WO2020196511A1 - Adapter - Google Patents

Adapter Download PDF

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Publication number
WO2020196511A1
WO2020196511A1 PCT/JP2020/012999 JP2020012999W WO2020196511A1 WO 2020196511 A1 WO2020196511 A1 WO 2020196511A1 JP 2020012999 W JP2020012999 W JP 2020012999W WO 2020196511 A1 WO2020196511 A1 WO 2020196511A1
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WO
WIPO (PCT)
Prior art keywords
puncture needle
adapter
circle
port
claws
Prior art date
Application number
PCT/JP2020/012999
Other languages
French (fr)
Japanese (ja)
Inventor
森岡淳治
野口央照
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
Publication of WO2020196511A1 publication Critical patent/WO2020196511A1/en

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    • 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
    • A61M39/02Access sites
    • A61M39/04Access sites having pierceable self-sealing members
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube

Definitions

  • the present invention relates to an adapter provided with a puncture needle capable of puncturing a female connector and a claw engaging with a female connector.
  • infusion solutions that administer drug solutions containing drugs, nutritional components, electrolytes, etc. to patients are widely used.
  • the infusion is generally performed according to the following procedure. First, prepare an infusion bag, a syringe, and an infusion set. Physiological saline and the like are stored in advance in the infusion bag. A liquid containing a drug or the like to be administered to a patient is stored in the syringe.
  • the infusion set consists of a long, flexible tube, the upstream end of which is provided with a puncture needle with a sharp tip and the downstream end of which is provided with an injection needle.
  • the metal needle of the syringe is punctured into the rubber stopper of the port of the infusion bag, the liquid in the syringe is injected into the infusion bag, and the drug solution is prepared in the infusion bag.
  • the metal needle is pulled out, and instead, the puncture needle of the infusion set is punctured into the rubber stopper of the port.
  • the needle of the infusion set is punctured into the patient's vein.
  • the clamp provided in the infusion set is opened to start the infusion.
  • the metal needle of the syringe and the puncture needle of the infusion set are sequentially pierced into the rubber stopper of the port of the infusion bag.
  • a puncture hole (puncture mark) remains in the rubber stopper after puncturing the metal needle.
  • the puncture needle deforms the rubber stopper.
  • the puncture hole is enlarged, and the drug solution in the infusion bag may leak to the outside through the puncture hole. This can lead to medical accidents in which workers and patients are exposed to drugs when the drug solution contains dangerous drugs such as anticancer drugs. Therefore, as shown in FIG.
  • a region 92 to be pierced with a metal needle and a region 93 to be pierced with a piercing needle may be displayed.
  • the region 92 and the region 93 are arranged apart from each other at positions off the center of the rubber stopper 91. As long as the metal needle and the puncture needle are correctly punctured in the region 92 and the region 93, respectively, the possibility of leakage of the drug solution is low.
  • a bag-shaped bag body constituting the infusion bag is attached to the base end 99 of the port 90, but the bag body is not shown in FIG.
  • the puncture needle of the infusion set may be simply punctured into the rubber stopper 91, the puncture needle may come out of the rubber stopper 91 when tension is applied to the tube of the infusion set. In this case, the chemical solution may leak to the outside world and a medical accident similar to the above may occur.
  • Patent Document 1 describes an example of an adapter for preventing unintentional separation between the port of the infusion bag and the infusion set.
  • the adapter comprises a puncture needle with a sharp tip, multiple claws arranged around the puncture needle, and a mixed injection port communicating with the puncture needle.
  • the puncture needle is pierced into the rubber stopper of the port of the infusion bag, and the plurality of claws are engaged with the port.
  • the mixed injection port includes a plate-shaped partition member (hereinafter referred to as “septum”) in which a linear slit is formed.
  • the septum is made of an elastic material such as rubber and functions as a self-closing valve.
  • a set having a male connector that can be connected to the mixed injection port is provided at the upstream end thereof (see, for example, Patent Document 2).
  • the male connector includes a male member inserted into the slit of the septum and a claw that engages with the mixed injection port (see, for example, Patent Document 3).
  • the multiple claws of the adapter engage the ports of the infusion bag, and the claws of the male connector of the infusion set engage the mixed injection port of the adapter, so that even if tensile force is applied to the infusion set, the port, adapter, The connection between the male connectors is maintained.
  • the adapter is configured such that the piercing needle pierces the center of the rubber stopper. Therefore, when the adapter is connected to the port 90, the puncture needle punctures the center of the rubber stopper 91 instead of the area 93 that should be punctured originally.
  • the adapter be connected to the port of the infusion bag before preparing the drug solution in the infusion bag. That is, the adapter is connected to the infusion bag in which the physiological saline or the like is stored and before the predetermined drug or the like is injected. A predetermined drug or the like is injected into the infusion bag through the mixed injection port of the adapter to prepare the drug solution. Then connect the infusion set to the mixed injection port. In this case, since the metal needle is not punctured in the rubber stopper 91, there is no problem even if the puncture needle of the adapter punctures the center of the rubber stopper 91 instead of the region 93.
  • a metal needle of a syringe is punctured into the area 92 of the rubber stopper 91 of the port 90 to inject a predetermined drug or the like into an infusion bag to prepare a drug solution, and then an adapter is attached to the port 90. May connect to.
  • the center of the rubber stopper 91 punctured by the puncture needle of the adapter is relatively close to the region 92 in which the puncture hole by the metal needle is formed. Therefore, when the puncture needle is punctured, the rubber stopper is deformed, the puncture hole by the metal needle is enlarged, and the chemical solution may leak.
  • An object of the present invention is to provide an adapter capable of puncturing a puncture needle at a position off the center of a rubber stopper.
  • the adapter of the present invention includes a puncture needle capable of puncturing a female connector, a plurality of claws protruding toward the puncture needle so as to engage with the female connector when the puncture needle is punctured into the female connector, and the plurality of claws.
  • the claws are provided, and a plurality of arms that can be elastically deformed so that the plurality of claws are separated from the puncture needle, and a mixed injection port communicating with the puncture needle are provided.
  • the piercing needle When viewed along the longitudinal direction of the piercing needle, the piercing needle is eccentric with respect to a circle inscribed in the plurality of nails.
  • the puncture needle can be punctured at a position off the center of the female connector while engaging a plurality of claws with the female connector.
  • FIG. 1 is a perspective view of an adapter according to the first embodiment of the present invention.
  • FIG. 2 is a perspective view of the adapter according to the first embodiment of the present invention as viewed from another direction.
  • FIG. 3 is a cross-sectional perspective view of the adapter according to the first embodiment of the present invention along the surface including the 3-3 line of FIG.
  • FIG. 4 is a bottom view of the adapter according to the first embodiment of the present invention.
  • FIG. 5 is a perspective view of the adapter according to the first embodiment of the present invention immediately before connecting to the port of the infusion bag.
  • FIG. 6 is a perspective view of the adapter according to the first embodiment of the present invention connected to the port of the infusion bag.
  • FIG. 7 is a cross-sectional view of the adapter according to the first embodiment of the present invention along the plane including the line 7-7 of FIG.
  • FIG. 8 is a perspective view of the adapter according to the second embodiment of the present invention.
  • FIG. 9 is a perspective view of the adapter according to the second embodiment of the present invention as viewed from another direction.
  • FIG. 10 is a cross-sectional perspective view of the adapter according to the second embodiment of the present invention along the surface including the line 10-10 of FIG.
  • FIG. 11 is a bottom view of the adapter according to the second embodiment of the present invention.
  • FIG. 12 is a perspective view of the adapter according to the second embodiment of the present invention connected to the port of the infusion bag.
  • FIG. 13 is a cross-sectional view of the adapter according to the second embodiment of the present invention along the plane including lines 13-13 of FIG.
  • FIG. 14 is a perspective view showing an example of a port of the infusion bag.
  • the plurality of claws may be unevenly arranged along the circle.
  • “Non-uniform” means that the plurality of claws are not evenly spaced along the circle, or that the plurality of claws are not evenly spaced with respect to the center of the circle.
  • an external force particularly, a tensile force via an infusion set
  • the tilt of the adapter with respect to the female connector is effective with a limited number of claws. It is advantageous to suppress the target.
  • the plurality of claws and the plurality of arms may not be arranged on the side where the center of the circle is located with respect to the puncture needle. Such an embodiment facilitates visual inspection of the tip of the puncture needle and the female connector when connecting the adapter to the female connector.
  • the adapter of the present invention may further include a top plate protruding outward at a position between the puncture needle and the mixed injection port.
  • the plurality of arms may be provided on the top plate.
  • the portion of the top plate on the side where the center of the circle is located with respect to the piercing needle may be cut out.
  • the mixed injection port may be eccentric to the circle on the same side as the puncture needle is eccentric to the circle.
  • the mixed injection port may be more eccentric with respect to the circle than the puncture needle.
  • Each of the plurality of arms may include a first elastic portion and a second elastic portion extending substantially parallel to the puncture needle.
  • the claw may be provided on the tip side of the first elastic portion and the second elastic portion.
  • the first elastic portion and the second elastic portion may be arranged along a circle concentric with the circle.
  • the first elastic portion may be arranged closer to the puncture needle than the second elastic portion.
  • the first elastic portion may have higher strength than the second elastic portion.
  • the arm provided with the claw closest to the puncture needle may have higher strength than the other arms.
  • Such an embodiment is advantageous in preventing the claw from being disengaged from the female connector when a tensile force is applied to the adapter with the adapter connected to the female connector.
  • FIG. 1 and 2 are perspective views of the adapter 1 according to the first embodiment of the present invention.
  • FIG. 3 is a cross-sectional perspective view of the adapter 1 along the surface including the 3-3 line of FIG.
  • the adapter 1 includes a puncture needle 10, two claws 20 protruding toward the puncture needle 10, two arms 30 provided with the two claws 20, and a mixed injection port 40.
  • the longitudinal direction of the puncture needle 10 is referred to as "vertical direction”
  • the direction parallel to the plane orthogonal to the longitudinal direction of the puncture needle 10 is referred to as "horizontal direction”.
  • the piercing needle 10 has a rod shape that extends straight, and its tip 11 is sharply formed.
  • a flow path 12 through which a liquid (for example, a chemical solution) flows is provided along the longitudinal direction of the puncture needle 10.
  • Two openings (horizontal holes) 13 are provided on the outer peripheral surface near the tip 11 of the puncture needle 10.
  • the flow path 12 communicates with the opening 13 and communicates with the outside world through the opening 13.
  • the top plate 35 is outward along the direction perpendicular to the longitudinal direction (that is, the radial direction) of the puncture needle 10. It is extending.
  • the top plate 35 is a thin plate having an outer peripheral edge having a substantially circular (or substantially arc) shape in a plan view (a shape viewed along the longitudinal direction of the piercing needle 10).
  • Two arms 30 extend downward from the outer peripheral edge of the top plate 35 so as to face the puncture needle 10.
  • Each arm 30 includes two elastic portions 31 extending in the vertical direction from the top plate 35 and a cross-linking portion 32 connecting the lower ends of the two elastic portions 31, thereby forming a substantially "U" shape as a whole.
  • the elastic portion 31 is an elongated plate-shaped member, and its main surface (the surface having the largest area) faces the puncture needle 10.
  • the cross-linked portion 32 has a substantially arc shape along a horizontal plane (a plane parallel to the horizontal direction).
  • a substantially rectangular opening 33 surrounded by the arm 30 and the top plate 35 is formed, and the puncture needle 10 inside the arm 30 can be seen through the opening 33.
  • a claw 20 is provided on the cross-linked portion 32 that constitutes the tip portion of each arm 30.
  • the claw 20 projects toward the puncture needle 10 from the surface of the cross-linking portion 32 facing the puncture needle 10.
  • the claw 20 includes a locking plate 22 and a rib 23 provided on the lower surface of the locking plate 22.
  • the locking plate 22 is a flat plate having a substantially trapezoidal shape, a substantially triangular shape, or a substantially fan shape, and is inclined toward the tip 21 (the portion closest to the puncture needle 10) so as to approach the top plate 35.
  • the tip (that is, the tip of the claw 20) 21 of the locking plate 22 is recessed in an arc shape.
  • the rib 23 is a thin plate-like protrusion protruding downward from the lower surface of the locking plate 22.
  • the lower edge 24 of the rib 23 is bulged in an arc shape, and smoothly connects the tip 21 of the claw 20 and the lower end of the bridge portion 32.
  • the arm 30 has a cantilever support structure having a fixed end at a connecting portion with the top plate 35.
  • the elastic portion 31 constituting the arm 30 can be elastically bent and deformed relatively easily.
  • the claw 20 is provided at the free end of the arm 30. Therefore, the arm 30 can be elastically deformed so that the claw 20 is separated from the puncture needle 10. Since the slits 36 are provided between the adjacent arms 30, each arm 30 can be deformed independently of each other.
  • the mixed injection port 40 includes a tubular portion 41 having a substantially cylindrical shape, a partition wall member (hereinafter referred to as “septum”) 45 provided at the upper end of the tubular portion 41, and a cap 47 covered with the septum 45.
  • the lumen 42 in the tubular portion 41 communicates with the flow path 12 in the puncture needle 10.
  • the septum 45 is a thin plate made of an elastic material such as rubber and having a circular plan view shape.
  • a linear slit (cut) 46 that penetrates the septum 45 in the vertical direction is formed in the center of the septum 45.
  • the septum 45 is placed on the upper end of the tubular portion 41, and the cap 47 is attached to the tubular portion 41 from above the septum 45.
  • the septum 45 is sandwiched in the vertical direction by the tubular portion 41 and the cap 47.
  • the slit 46 of the septum 45 is exposed in the opening 48 formed on the upper surface of the cap 47.
  • FIG. 4 is a bottom view of the adapter 1 viewed from the tip 11 side of the puncture needle 10 along the longitudinal direction of the puncture needle 10.
  • the arc of the tip 21 of the two claws 20 is along the common circle 25 indicated by the alternate long and short dash line.
  • the point 26 is the center of the circle 25.
  • the cross-linked portion 32 of the arm 30 is along a common circle concentric with the circle 25.
  • the main surface of the elastic portion 31 of the arm 30 is in contact with a common circle concentric with the circle 25.
  • the outer peripheral edge of the top plate 35 (see FIGS. 1 and 2) is also along a circle concentric with the circle 25.
  • the puncture needle 10 is located off the center 26 of the circle 25.
  • the piercing needle 10 is eccentric with respect to the circle 25 inscribed in the tip 21 of the claw 20.
  • the side where the puncture needle 10 is located with respect to the center 26 of the circle 25 is referred to as the "eccentric side” (the side facing the arrow D1 in FIG. 4), and the puncture needle 10 is located with respect to the center 26 of the circle 25.
  • the side opposite to the position side (that is, the side where the center 26 of the circle 25 is located with respect to the puncture needle 10) is referred to as the "anti-eccentric side” (the side in which the arrow D2 faces in FIG. 4).
  • the puncture needle 10 is located inside the circle 25.
  • the surface S including the center 26 and the central axis of the puncture needle 10 (not shown.
  • the central axis passes through the tip 11 and extends along the longitudinal direction of the puncture needle 10) is referred to as an "eccentric direction surface".
  • the cross section of FIG. 3 coincides with the eccentric direction plane S.
  • the claw 20 is arranged so that the distance from the piercing needle 10 to the claw 20 (particularly the tip 21 thereof) is shortened on the eccentric side D1.
  • the claws 20 are unevenly arranged along the circle 25.
  • the claw 20 and the arm 30 are not arranged on the anti-eccentric side D2 with respect to the center 26 (or the puncture needle 10).
  • the top plate 35 is provided with a notch 37 extending from the edge of the anti-eccentric side D2 to the vicinity of the proximal end of the puncture needle 10 (see FIG. 1).
  • the adapter 1 is symmetrical with respect to the eccentric plane S.
  • the portion of the adapter 1 excluding the septum 45 and the cap 47 is integrally manufactured as one part by injection molding a resin material.
  • the resin material that can be used is not limited, and examples thereof include polyethylene, polypropylene, polycarbonate, styrene ethylene, polyethylene terephthalate, polybutylene terephthalate, and butylene styrene block copolymer, but those used for medical purposes and arms. Considering that 30 is elastically bent and deformed, polyolefin resins such as polyethylene and polypropylene are preferable.
  • the material of the cap 47 is not limited, but is preferably a hard material, and for example, a resin material such as polycarbonate, polypropylene, polyacetal, polyamide, hard polyvinyl chloride, and polyethylene can be used.
  • the material of the septum 45 is not limited, but is preferably a soft material having rubber elasticity, and for example, a rubber material such as isoprene rubber, silicone rubber, or butyl rubber, a thermoplastic elastomer, or the like can be used.
  • the adapter 1 is made to face the port (female connector) 90 of the infusion bag.
  • the port 90 is the same as that shown in FIG.
  • the infusion bag includes a port 90 and a flexible bag-shaped bag body attached to the base end 99 of the port 90. Similar to FIG. 14, in FIG. 5, the bag body is not shown.
  • the upwardly facing opening 95 of the port 90 is sealed with a rubber stopper 91.
  • a predetermined drug or the like has already been injected into the infusion bag by puncturing the area 92 of the rubber stopper 91 with a metal needle of a syringe. Therefore, a puncture hole (puncture mark) 92a by a metal needle is formed in the region 92. Since the rubber stopper 91 elastically recovers when the metal needle is removed, the puncture hole 92a is substantially closed in the state of FIG.
  • the adapter 1 is brought close to the port 90, and the puncture needle 10 is punctured into the area 93 of the rubber stopper 91.
  • the adapter 1 When the adapter 1 is pushed toward the port 90, the piercing needle 10 is inserted into the rubber stopper 91, and in parallel with this, the end edge 24 (see FIG. 3) of the rib 23 integrally provided on the claw 20 is ported. It slides on the upper edge 96 of 90. The edge 24 moves the claw 20 away from the puncture needle 10 (outside) while sliding on the upper edge 96. As the claw 20 moves, the elastic portion 31 of the arm 30 elastically bends and deforms. Further, the adapter 1 is pushed toward the port 90. When the tip 21 of the claw 20 exceeds the step 97 of the port 90, the elastic portion 31 elastically recovers, and the claw 20 fits into the small diameter portion 98 having a relatively small outer diameter. The claw 20 engages with a step 97 adjacent to the small diameter portion 98.
  • FIG. 7 is a cross-sectional view taken along a plane (eccentric direction plane) including the line 7-7 of FIG.
  • the two claws 20 sandwich the small diameter portion 98 of the port 90.
  • the claw 20 is substantially along a circle concentric with the central axis (not shown) of the port 90.
  • the two claws 20 each stably engage the port 90. Even if a force is applied to the adapter 1 and the port 90 in a direction to separate them, the engagement of the claw 20 with the port 90 is not disengaged.
  • the arm 30 can be appropriately deformed according to the outer diameter of the port 90.
  • the adapter 1 can be connected to a plurality of types of ports 90 having different outer diameters.
  • the puncture needle 10 is eccentric with respect to the inscribed circle 25 of the nail 20 (see FIG. 4). Therefore, when the claw 20 engages with the port 90, the puncture needle 10 makes the region 93 off the center of the rubber stopper 91 perpendicular to the surface of the rubber stopper 91 (or on the central axis of the port 90). Puncture (in parallel).
  • the puncture needle is arranged at the center of the circle inscribed in the tips of a plurality of nails when viewed along the longitudinal direction of the puncture needle. Therefore, in order to properly engage the plurality of claws with the port 90, it is necessary to puncture the puncture needle in the center of the rubber stopper 91. Since the center of the rubber stopper 91 is close to the puncture hole 92a by the metal needle already formed in the region 92, the puncture hole 92a expands when the puncture needle pierces the rubber stopper 91, and the drug solution in the infusion bag leaks out. The problem arises.
  • the adapter 1 of the first embodiment can solve the above-mentioned problems of the conventional adapter.
  • the puncture needle 10 can puncture the region 93 off the center of the rubber stopper 91 without tilting with respect to the rubber stopper 91. Region 93 is separated from Region 92. Therefore, even if the puncture hole 92a by the metal needle is formed in the region 92, the puncture hole 92a is not expanded by puncturing the rubber stopper 91 with the puncture needle 10, and the drug solution does not leak out.
  • the male connector After connecting the adapter 1 to the port 90 as shown in FIGS. 6 and 7, connect the male connector (not shown) at the upstream end of the infusion set to the mixed injection port 40 of the adapter 1.
  • the male connector includes a male member inserted into the slit 46 of the septum 45 and a claw that engages with the mixed injection port 40 (see, for example, Patent Document 3).
  • the claw 20 of the adapter 1 engages the port 90, and the claw of the male connector engages the mixed injection port 40. Therefore, even if a tensile force is applied to the infusion set, the connection between the port 90, the adapter 1, and the male connector is maintained.
  • a notch 37 is formed on the top plate 35.
  • the notch 37 is provided from the edge of the anti-eccentric side D2 of the top plate 35 toward the piercing needle 10.
  • the notch 37 has the following effects. First, as can be seen from FIGS. 5 and 6, when the adapter 1 is connected to the port 90, the tip 11 of the puncture needle 10 and the upper surface (particularly the region 93) of the rubber stopper 91 are connected through the notch 37. Can be visually observed. This is advantageous for accurately puncturing the puncture needle 10 into the region 93 of the rubber stopper 91. Second, as shown in FIGS. 6 and 7, after the adapter 1 is connected to the port 90, the upper surface (particularly the region 92) of the rubber stopper 91 is exposed through the notch 37.
  • the arm 30 is not provided in the portion of the top plate 35 where the notch 37 is provided. Therefore, the claw 20 and the arm 30 are not arranged on the side (anti-eccentric side D2) where the center 26 of the inscribed circle 25 is located with respect to the puncture needle 10. This makes it easy to visually recognize the tip 11 of the puncture needle 10 and the upper surface (particularly the region 93) of the rubber stopper 91 from the anti-eccentric side D2 when the adapter 1 is connected to the port 90 (FIG. 5, FIG. (See FIG. 6).
  • the mixed injection port 40 is eccentric to the inscribed circle 25 (see FIG. 4) of the claw 20 on the same side (eccentric side D1) as the puncture needle 10 is eccentric. ..
  • the mixed injection port 40 is more eccentric to the eccentric side D1 with respect to the inscribed circle 25 than the puncture needle 10. Therefore, even if the mixed injection port 40 has a diameter larger than that of the puncture needle 10, the mixed injection port 40 does not substantially overlap the notch 37 formed in the top plate 35 in the vertical direction. The notch 37 is opened upward without being blocked by the mixed injection port 40.
  • the claws 20 are along the inscribed circle 25 so that the distance between the adjacent claws 20 along the circumferential direction is narrow on the eccentric side D1 and wide on the anti-eccentric side D2. Is unevenly arranged. That is, on the eccentric side D1 where the distance from the puncture needle 10 to the claw 20 (particularly, the tip 21 thereof) is relatively short, the distance between the claws 20 is narrow.
  • the fact that the claws 20 are densely arranged near the piercing needle 10 in this way suppresses the inclination of the adapter 1 with respect to the port 90 when an external force is applied to the adapter 1 while the adapter 1 is connected to the port 90. It is advantageous for.
  • the tensile force applied to the infusion set acts upward on the mixed injection port 40 as shown by the arrow F in FIG.
  • the tensile force F generates a rotational moment with the engagement point between the claw 20 and the port 90 as a fulcrum.
  • the magnitude of the rotational moment depends on the horizontal distance from the mixed injection port 40 to the claw 20.
  • the mixed injection port 40 is eccentric to the eccentric side D1 (preferably larger than the puncture needle 10) with respect to the inscribed circle 25. This shortens the horizontal distance between the mixed injection port 40 and the claw 20. Therefore, the rotational moment becomes small. This is advantageous for reducing the inclination of the adapter 1 with respect to the port 90 when a tensile force F is applied to the adapter 1.
  • the claw 20 When the adapter 1 is tilted with respect to the port 90, the claw 20 is disengaged from the port 90.
  • the puncture needle 10 is tilted with respect to the rubber stopper 91 to form a gap between the puncture needle 10 and the rubber stopper 91.
  • the chemical solution in the chemical solution bag leaks to the outside through this gap, and the like may occur. In the first embodiment, such a problem is unlikely to occur.
  • the slit 36 between the adjacent arms 30 does not reach the top plate 35 (see FIG. 2).
  • the first elastic portion 31a adjacent to the slit 36 is shorter than the second elastic portion 31b. Therefore, the first elastic portion 31a has higher strength than the second elastic portion 31b and is less likely to be bent and deformed.
  • the relatively high-strength first elastic portion 31a is arranged closer to the puncture needle 10 (or mixed injection port 40) than the second elastic portion 31b. (See FIGS. 1 to 4). This is advantageous in preventing the claw 20 from being disengaged from the port 90 when a tensile force F is applied. The reason for this is as follows.
  • the tensile force F acts on the mixed injection port 40 to pull the adapter 1 away from the port 90 along the longitudinal direction of the puncture needle 10 (see FIG. 7).
  • the first elastic portion 31a which is closer to the puncture needle 10 and the mixed injection port 40, mainly opposes the tensile force F.
  • the relatively high strength of the first elastic portion 31a reduces the deformation of the first elastic portion 31a when a tensile force F is applied to the mixed injection port 40. Therefore, the engagement of the claw 20 with the port 90 is difficult to be disengaged.
  • the relatively low strength of the second elastic portion 31b facilitates the work of connecting the adapter 1 to the port 90.
  • the method of making the first elastic portion 31a stronger than the second elastic portion 31b is not limited to the first embodiment and is arbitrary.
  • the first elastic portion 31a may have a relatively high strength by increasing the cross-sectional area of the first elastic portion 31a, providing a rib for reinforcement in the first elastic portion 31a, or the like.
  • the first elastic portion 31a and the second elastic portion 31b may have substantially the same strength.
  • FIG. 10 is a cross-sectional perspective view of the adapter 2 along the surface (eccentric direction surface) including the line 10-10 of FIG.
  • the adapter 2 of the second embodiment has two claws 20 and two arms 30 in that it includes three claws 220 protruding toward the puncture needle 10 and three arms 230 provided with the three claws 220. It is different from the adapter 1 of the first embodiment including.
  • the adapter 2 of the second embodiment will be described with a focus on the differences from the first embodiment.
  • the claw 220a is arranged between the claw 220b and the claw 220c.
  • the claws 220a, 220b, 220c are provided on the arms 230a, 230b, 230c, respectively.
  • each arm 230 extend downward from the outer peripheral edge of the top plate 35 so as to face the puncture needle 10. Similar to the arm 30 of the first embodiment, each arm 230 includes two elastic portions 31 extending in the vertical direction from the top plate 35 and a bridging portion 32 connecting the lower ends of the two elastic portions 31. As a whole, it has a substantially "U" shape.
  • a claw 220 is provided on the cross-linked portion 32 forming the tip portion of the arm 230.
  • the claw 220 protrudes toward the piercing needle 10 from the surface of the bridging portion 32 facing the piercing needle 10.
  • each claw 220 includes a locking plate 22 and a rib 23 provided on the lower surface of the locking plate 22.
  • Two ribs 23 are provided on the central claw 220a, and one rib 23 is provided on the claws 220b and 230c on both sides thereof.
  • the arm 230 can be elastically deformed so that the claw 220 is separated from the puncture needle 10. Since the slits 36 are provided between the arm 230a and the arm 230b and between the arm 230a and the arm 230c, the arms 230a, 230b, and 230c can be deformed independently of each other.
  • FIG. 11 is a bottom view of the adapter 2 as viewed from the tip 11 side of the puncture needle 10 along the longitudinal direction of the puncture needle 10. Similar to the first embodiment, the arc of the tip 21 of the three claws 220 is along the common circle 25 indicated by the two-point chain line.
  • the cross-linked portion 32 of the arm 230 is along a common circle concentric with the circle 25.
  • the main surface of the elastic portion 31 of the arm 230 is in contact with a common circle concentric with the circle 25.
  • the outer peripheral edge of the top plate 35 (see FIGS. 8 and 9) is also along a circle concentric with the circle 25.
  • the puncture needle 10 is eccentric to the eccentric side D1 with respect to the circle 25.
  • the claws 220 are unevenly arranged along the circle 25.
  • the claw 220 and the arm 230 are not arranged on the anti-eccentric side D2 with respect to the center 26 (or the piercing needle 10).
  • the top plate 35 is provided with a notch 37 extending from the edge of the anti-eccentric side D2 to the vicinity of the proximal end of the puncture needle 10.
  • the adapter 2 is symmetrical with respect to the eccentric plane S.
  • the central claw 220a is located on the eccentric direction surface S.
  • FIG. 12 is a perspective view of the adapter 2 connected to the port 90.
  • FIG. 13 is a cross-sectional view taken along a plane (eccentric direction plane) including lines 13-13 of FIG.
  • the three claws 220 engage with the step 97 of the port 90 and sandwich the small diameter portion 98.
  • the claw 220 is substantially along a circle concentric with the central axis (not shown) of the port 90.
  • Each of the three claws 220 is stably engaged with the port 90. Even if a force is applied to the adapter 2 and the port 90 in a direction to separate them, the engagement of the claw 220 with the port 90 is not disengaged.
  • the puncture needle 10 punctures the region 93 off the center of the rubber stopper 91 perpendicularly to the surface of the rubber stopper 91 (or parallel to the central axis of the port 90). Even if the puncture hole 92a by the metal needle is formed in the region 92 of the rubber stopper 91, the puncture hole 92a is not expanded by puncturing the region 93 with the puncture needle 10 and the drug solution does not leak out.
  • a male connector (not shown) at the upstream end of the infusion set is connected to the mixed injection port 40 of the adapter 2.
  • the claw 220 is along the inscribed circle 25 so that the distance between adjacent claws 220 along the circumferential direction is narrow on the eccentric side D1 and wide on the anti-eccentric side D2. Is unevenly arranged.
  • the claw 220a located on the eccentric side D1 with respect to the piercing needle 10 is arranged closest to the piercing needle 10.
  • Such an arrangement of the claws 220 is advantageous in suppressing the inclination of the adapter 2 with respect to the port 90 when an external force is applied to the adapter 2 while the adapter 2 is connected to the port 90.
  • the mixed injection port 40 is eccentric to the eccentric side D1 (preferably larger than the puncture needle 10) with respect to the inscribed circle 25. Therefore, the horizontal distance from the mixed injection port 40 to the claw 220 (particularly the claw 220a) is short. This is advantageous in suppressing the inclination of the adapter 2 with respect to the port 90 when a tensile force F (see FIG. 13) is applied to the adapter 2.
  • the distance between the two elastic portions 31 constituting the arm 230a provided with the claw 220a is the distance between the two elastic portions 31 constituting the arms 230b and 230c, respectively. Greater than the distance. Therefore, the arm 230a has higher strength than the arms 230b and 230c and is less likely to be bent and deformed.
  • the main surface of each elastic portion 31 faces the center 26 of the inscribed circle 25.
  • the claw 220 When viewed along the longitudinal direction of the piercing needle 10, the claw 220 constitutes a direction in which the claw 220 moves away from the piercing needle 10 (or the center 26 of the inscribed circle 25) and an arm 230 provided with the claw 220.
  • the arm 230a is relatively strong with respect to moving the claw 230a.
  • the arm 230a is provided with a claw 220a closest to the puncture needle 10. This is advantageous in preventing the claw 220 (particularly the claw 220a) from being disengaged from the port 90 when a tensile force F is applied. This is because the claw 220a and the arm 230a mainly oppose the tensile force F.
  • the relatively low strength of the arms 230b and 230c facilitates the work of connecting the adapter 2 to the port 90.
  • the method of making the arm 230a stronger than the arms 230b and 230c is not limited to the second embodiment and is arbitrary.
  • the arm 230a may be made relatively high in strength by increasing the cross-sectional area of the elastic portion 31 constituting the arm 230a, providing reinforcing ribs in the elastic portion 31 constituting the arm 230a, or the like. .. Unlike the second embodiment, in the present invention, all the arms 230 may have substantially the same strength.
  • the elastic portion (first elastic portion) close to the puncture needle 10 may be configured with relatively high strength. ..
  • the number of claws and arms included in the adapter of the present invention is not limited to the above embodiment.
  • the number of claws and arms is preferably two or more, and may be four or more.
  • the shape of the claw can be changed arbitrarily.
  • the tip 21 of the nail does not need to be provided with an arcuate recess along the inscribed circle 25 of the nail.
  • the tip 21 of the nail may be provided with a flat surface or an arc-shaped or dome-shaped convex portion.
  • the shape of the claw locking plate 22 can be changed arbitrarily. Further, the locking plate 22 does not need to be inclined so as to approach the top plate 35 toward the tip 21.
  • the locking plate 22 may be omitted, and the claws may be composed of ribs 23 parallel to each other in the vertical direction.
  • the number of ribs 23 provided on one claw is arbitrary.
  • the shape of the rib 23 is also arbitrary.
  • the claws may not have ribs 23.
  • Two or more claws may be provided on one arm.
  • a plurality of claws and a plurality of arms may be arranged at equal intervals with respect to the center 26 (that is, at equal intervals in the circumferential direction along the inscribed circle 25).
  • the shape of the arm can also be changed arbitrarily.
  • the arm need not be composed of two elastic portions 31 and one bridging portion 32 connecting the lower ends thereof.
  • the arm may not include a member corresponding to the cross-linked portion 32.
  • the arm may consist of only one rod-shaped (or elongated plate-shaped) elastic portion extending in the vertical direction.
  • the shape of the top plate 35 is arbitrary.
  • the plan view shape of the top plate 35 is not limited to a circle, but may be an ellipse, a polygon (for example, a triangle, a quadrangle), or the like.
  • the top plate 35 does not have to have the notch 37.
  • the adapter of the present invention does not have to include the top plate 35.
  • the arm may extend from the base end of the puncture needle 10.
  • the horizontal position of the mixed injection port 40 is also arbitrary.
  • the mixed injection port 40 may be arranged coaxially with the puncture needle 10 or may be arranged concentrically with the inscribed circle 25.
  • the mixed injection port 40 and the puncture needle 10 may be connected via a flexible tube.
  • the configuration of the mixed injection port 40 is not limited to the needleless port shown in the above embodiment.
  • the self-closing valve function may be realized by a configuration other than the septum 45.
  • the mixed injection port does not have to have a self-closing valve function.
  • the mixed injection port may be a known connector (female connector) having a tapered surface. Any known mixed injection port can be applied to the adapter of the present invention.
  • only one flow path 12 through which the liquid flows is formed in the puncture needle 10, but in addition to the flow path through which the liquid flows, a flow in which a gas flows in order to prevent pressure fluctuation in the container. Roads may be formed.
  • the metal needle of the syringe was punctured into the rubber stopper 91 to prepare the drug solution in the infusion bag.
  • the present invention is not limited to this.
  • the adapter may be connected to the port 90 without puncturing the rubber stopper 91 with a metal needle. After that, a predetermined drug or the like may be injected into the infusion bag via the adapter to prepare the drug solution.
  • the area to which the metal needle should be punctured and the area 93 to which the puncture needle should be punctured may not be displayed on the port to which the adapter of the present invention is connected.
  • the female connector to which the adapter of the present invention is connected is not limited to the port of the infusion bag.
  • the adapter of the present invention may be connected to the vial.
  • the female connector comprises a plug capable of piercing the piercing needle (eg, a rubber plug).
  • the liquid flowing through the flow path 12 of the puncture needle 10 may be a chemical solution, but may be any liquid other than the chemical solution.
  • the present invention is not limited, but can be preferably used in the medical field, especially in infusion.
  • the adapter of the present invention can be preferably used as an adapter for connecting to a female connector of a container that stores a liquid (particularly a chemical solution).

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Abstract

This adapter (1) is provided with: a puncture needle (10); a plurality of claws (20) that protrude toward the puncture needle (10); a plurality of elastically-deformable arms (30) that are provided with the plurality of claws (20); and a co-injection port (40) that is connected to the puncture needle (10). The puncture needle (10) is disposed eccentrically with respect to a circle (25) that inscribes the plurality of claws (20) when viewed along the longitudinal direction of the puncture needle (10).

Description

アダプタadapter
 本発明は、メスコネクタに穿刺可能な穿刺針と、メスコネクタに係合可能な爪とを備えたアダプタに関する。 The present invention relates to an adapter provided with a puncture needle capable of puncturing a female connector and a claw engaging with a female connector.
 医療の分野において、薬剤や、栄養成分、電解質などを含む薬液を患者に投与する輸液が広く行われている。輸液は、概略以下の手順で行われる。最初に、輸液バッグとシリンジと輸液セットとを用意する。輸液バッグ内には、生理食塩水等があらかじめ貯留されている。シリンジには、患者に投与する薬剤等を含む液体が貯留されている。輸液セットは、長尺の柔軟なチューブからなり、その上流端には、鋭利な先端を備えた穿刺針が設けられ、その下流端には注射針が設けられている。次に、輸液バッグのポートのゴム栓にシリンジの金属針を穿刺して、シリンジ内の液体を輸液バッグに注入し、輸液バッグ内で薬液を調製する。その後、金属針を抜き、代わりに、ポートのゴム栓に輸液セットの穿刺針を穿刺する。輸液セットの注射針を患者の静脈に穿刺する。そして、輸液セットに設けられたクランプを開いて、輸液を開始する。 In the medical field, infusion solutions that administer drug solutions containing drugs, nutritional components, electrolytes, etc. to patients are widely used. The infusion is generally performed according to the following procedure. First, prepare an infusion bag, a syringe, and an infusion set. Physiological saline and the like are stored in advance in the infusion bag. A liquid containing a drug or the like to be administered to a patient is stored in the syringe. The infusion set consists of a long, flexible tube, the upstream end of which is provided with a puncture needle with a sharp tip and the downstream end of which is provided with an injection needle. Next, the metal needle of the syringe is punctured into the rubber stopper of the port of the infusion bag, the liquid in the syringe is injected into the infusion bag, and the drug solution is prepared in the infusion bag. After that, the metal needle is pulled out, and instead, the puncture needle of the infusion set is punctured into the rubber stopper of the port. The needle of the infusion set is punctured into the patient's vein. Then, the clamp provided in the infusion set is opened to start the infusion.
 上記の手順では、輸液バッグのポートのゴム栓に、シリンジの金属針と、輸液セットの穿刺針とが順次穿刺される。金属針を穿刺した後のゴム栓には穿刺孔(穿刺痕)が残る。相対的に太い穿刺針をゴム栓に穿刺したとき、穿刺針はゴム栓を変形させる。金属針による穿刺孔の近くに穿刺針を穿刺すると、穿刺孔が拡大され、その穿刺孔を通じて輸液バッグ内の薬液が外界に漏れ出る場合がある。これは、薬液が抗がん剤などの危険薬剤を含む場合には、作業者や患者が薬剤被爆するという医療事故につながり得る。そこで、図14に示すように、ポート90のゴム栓91の外面に、金属針を穿刺すべき領域92と穿刺針を穿刺すべき領域93とが表示されている場合がある。領域92及び領域93は、ゴム栓91の中央から外れた位置に、互いに離れて配置されている。金属針及び穿刺針を領域92及び領域93にそれぞれ正しく穿刺する限り、薬液の漏れ出しが起こる可能性は低い。なお、実際には、ポート90の基端99に、輸液バッグを構成する袋状のバッグ本体が取り付けられているが、図14ではバッグ本体の図示を省略している。 In the above procedure, the metal needle of the syringe and the puncture needle of the infusion set are sequentially pierced into the rubber stopper of the port of the infusion bag. A puncture hole (puncture mark) remains in the rubber stopper after puncturing the metal needle. When a relatively thick puncture needle is punctured into a rubber stopper, the puncture needle deforms the rubber stopper. When a puncture needle is pierced near a puncture hole by a metal needle, the puncture hole is enlarged, and the drug solution in the infusion bag may leak to the outside through the puncture hole. This can lead to medical accidents in which workers and patients are exposed to drugs when the drug solution contains dangerous drugs such as anticancer drugs. Therefore, as shown in FIG. 14, on the outer surface of the rubber stopper 91 of the port 90, a region 92 to be pierced with a metal needle and a region 93 to be pierced with a piercing needle may be displayed. The region 92 and the region 93 are arranged apart from each other at positions off the center of the rubber stopper 91. As long as the metal needle and the puncture needle are correctly punctured in the region 92 and the region 93, respectively, the possibility of leakage of the drug solution is low. In reality, a bag-shaped bag body constituting the infusion bag is attached to the base end 99 of the port 90, but the bag body is not shown in FIG.
 輸液セットの穿刺針をゴム栓91に単に穿刺しただけでは、輸液セットのチューブに張力が加えられたときに、穿刺針がゴム栓91から抜け出てしまう場合がある。この場合、薬液が外界に漏れ出て、上記と同様の医療事故が発生する可能性がある。 If the puncture needle of the infusion set is simply punctured into the rubber stopper 91, the puncture needle may come out of the rubber stopper 91 when tension is applied to the tube of the infusion set. In this case, the chemical solution may leak to the outside world and a medical accident similar to the above may occur.
 輸液バッグのポートと輸液セットとの意図しない分離を防止するためのアダプタの一例が、特許文献1に記載されている。このアダプタは、鋭利な先端を有する穿刺針と、穿刺針の周囲に配された複数の爪と、穿刺針に連通した混注ポートとを備える。穿刺針は輸液バッグのポートのゴム栓に穿刺され、複数の爪はポートに係合される。混注ポートは、直線状のスリットが形成された板状の隔壁部材(以下「セプタム」という)を備える。セプタムは、ゴム等の弾性材料からなり、自閉式の弁として機能する。輸液セットとして、その上流端に、混注ポートに接続可能なオスコネクタが設けられたものを用いる(例えば特許文献2参照)。オスコネクタは、セプタムのスリットに挿入されるオス部材と、混注ポートに係合する爪とを備える(例えば特許文献3参照)。アダプタの複数の爪が輸液バッグのポートに係合し、且つ、輸液セットのオスコネクタの爪がアダプタの混注ポートに係合するので、輸液セットに引張り力が加えられても、ポート、アダプタ、オスコネクタ間の接続は維持される。 Patent Document 1 describes an example of an adapter for preventing unintentional separation between the port of the infusion bag and the infusion set. The adapter comprises a puncture needle with a sharp tip, multiple claws arranged around the puncture needle, and a mixed injection port communicating with the puncture needle. The puncture needle is pierced into the rubber stopper of the port of the infusion bag, and the plurality of claws are engaged with the port. The mixed injection port includes a plate-shaped partition member (hereinafter referred to as “septum”) in which a linear slit is formed. The septum is made of an elastic material such as rubber and functions as a self-closing valve. As the infusion set, a set having a male connector that can be connected to the mixed injection port is provided at the upstream end thereof (see, for example, Patent Document 2). The male connector includes a male member inserted into the slit of the septum and a claw that engages with the mixed injection port (see, for example, Patent Document 3). The multiple claws of the adapter engage the ports of the infusion bag, and the claws of the male connector of the infusion set engage the mixed injection port of the adapter, so that even if tensile force is applied to the infusion set, the port, adapter, The connection between the male connectors is maintained.
 上記のアダプタでは、複数の爪が、穿刺針を中心とする共通の円に沿って等間隔で配置されている。即ち、アダプタは、穿刺針がゴム栓の中央を穿刺するように構成されている。このため、アダプタをポート90に接続したとき、穿刺針は、本来穿刺すべき領域93ではなく、ゴム栓91の中央を穿刺してしまう。 In the above adapter, multiple nails are arranged at equal intervals along a common circle centered on the puncture needle. That is, the adapter is configured such that the piercing needle pierces the center of the rubber stopper. Therefore, when the adapter is connected to the port 90, the puncture needle punctures the center of the rubber stopper 91 instead of the area 93 that should be punctured originally.
 アダプタは、輸液バッグ内で薬液を調製する前に、輸液バッグのポートに接続されることが推奨されている。即ち、アダプタは、生理食塩水等が貯留され且つ所定の薬剤等が注入される前の輸液バッグに接続される。アダプタの混注ポートを介して、所定の薬剤等を輸液バッグに注入し、薬液を調製する。その後、混注ポートに輸液セットを接続する。この場合、ゴム栓91には、金属針は穿刺されないから、アダプタの穿刺針が、領域93ではなく、ゴム栓91の中央を穿刺しても何ら問題はない。 It is recommended that the adapter be connected to the port of the infusion bag before preparing the drug solution in the infusion bag. That is, the adapter is connected to the infusion bag in which the physiological saline or the like is stored and before the predetermined drug or the like is injected. A predetermined drug or the like is injected into the infusion bag through the mixed injection port of the adapter to prepare the drug solution. Then connect the infusion set to the mixed injection port. In this case, since the metal needle is not punctured in the rubber stopper 91, there is no problem even if the puncture needle of the adapter punctures the center of the rubber stopper 91 instead of the region 93.
特開2014-079355号公報Japanese Unexamined Patent Publication No. 2014-07935 国際公開第2018/074294号International Publication No. 2018/074294 国際公開第2013/154050号International Publication No. 2013/154050
 ところが、実際の医療の現場では、ポート90のゴム栓91の領域92にシリンジの金属針を穿刺して所定の薬剤等を輸液バッグに注入して薬液を調製し、続いて、アダプタをポート90に接続する場合がある。アダプタの穿刺針が穿刺するゴム栓91の中央は、金属針による穿刺孔が形成された領域92から比較的近い。このため、穿刺針を穿刺すると、ゴム栓が変形し、金属針による穿刺孔が拡大され、薬液が漏れ出る可能性がある。 However, in an actual medical field, a metal needle of a syringe is punctured into the area 92 of the rubber stopper 91 of the port 90 to inject a predetermined drug or the like into an infusion bag to prepare a drug solution, and then an adapter is attached to the port 90. May connect to. The center of the rubber stopper 91 punctured by the puncture needle of the adapter is relatively close to the region 92 in which the puncture hole by the metal needle is formed. Therefore, when the puncture needle is punctured, the rubber stopper is deformed, the puncture hole by the metal needle is enlarged, and the chemical solution may leak.
 本発明は、穿刺針をゴム栓の中央から外れた位置に穿刺することができるアダプタを提供することを目的とする。 An object of the present invention is to provide an adapter capable of puncturing a puncture needle at a position off the center of a rubber stopper.
 本発明のアダプタは、メスコネクタに穿刺可能な穿刺針と、前記穿刺針をメスコネクタに穿刺したとき前記メスコネクタに係合するように前記穿刺針に向かって突出した複数の爪と、前記複数の爪が設けられ、前記複数の爪が前記穿刺針から離れるように弾性変形可能な複数のアームと、前記穿刺針に連通した混注ポートとを備える。前記穿刺針の長手方向に沿って見たとき、前記複数の爪に内接する円に対して前記穿刺針が偏心している。 The adapter of the present invention includes a puncture needle capable of puncturing a female connector, a plurality of claws protruding toward the puncture needle so as to engage with the female connector when the puncture needle is punctured into the female connector, and the plurality of claws. The claws are provided, and a plurality of arms that can be elastically deformed so that the plurality of claws are separated from the puncture needle, and a mixed injection port communicating with the puncture needle are provided. When viewed along the longitudinal direction of the piercing needle, the piercing needle is eccentric with respect to a circle inscribed in the plurality of nails.
 本発明のアダプタによれば、複数の爪をメスコネクタに係合させながら、穿刺針をメスコネクタの中央から外れた位置に穿刺することができる。 According to the adapter of the present invention, the puncture needle can be punctured at a position off the center of the female connector while engaging a plurality of claws with the female connector.
図1は、本発明の実施形態1にかかるアダプタの斜視図である。FIG. 1 is a perspective view of an adapter according to the first embodiment of the present invention. 図2は、本発明の実施形態1にかかるアダプタの別の方向から見た斜視図である。FIG. 2 is a perspective view of the adapter according to the first embodiment of the present invention as viewed from another direction. 図3は、図1の3-3線を含む面に沿った、本発明の実施形態1にかかるアダプタの断面斜視図である。FIG. 3 is a cross-sectional perspective view of the adapter according to the first embodiment of the present invention along the surface including the 3-3 line of FIG. 図4は、本発明の実施形態1にかかるアダプタの下面図である。FIG. 4 is a bottom view of the adapter according to the first embodiment of the present invention. 図5は、輸液バッグのポートに接続する直前の、本発明の実施形態1にかかるアダプタの斜視図である。FIG. 5 is a perspective view of the adapter according to the first embodiment of the present invention immediately before connecting to the port of the infusion bag. 図6は、輸液バッグのポートに接続された本発明の実施形態1にかかるアダプタの斜視図である。FIG. 6 is a perspective view of the adapter according to the first embodiment of the present invention connected to the port of the infusion bag. 図7は、図6の7-7線を含む面に沿った、本発明の実施形態1にかかるアダプタの断面図である。FIG. 7 is a cross-sectional view of the adapter according to the first embodiment of the present invention along the plane including the line 7-7 of FIG. 図8は、本発明の実施形態2にかかるアダプタの斜視図である。FIG. 8 is a perspective view of the adapter according to the second embodiment of the present invention. 図9は、本発明の実施形態2にかかるアダプタの別の方向から見た斜視図である。FIG. 9 is a perspective view of the adapter according to the second embodiment of the present invention as viewed from another direction. 図10は、図8の10-10線を含む面に沿った、本発明の実施形態2にかかるアダプタの断面斜視図である。FIG. 10 is a cross-sectional perspective view of the adapter according to the second embodiment of the present invention along the surface including the line 10-10 of FIG. 図11は、本発明の実施形態2にかかるアダプタの下面図である。FIG. 11 is a bottom view of the adapter according to the second embodiment of the present invention. 図12は、輸液バッグのポートに接続された本発明の実施形態2にかかるアダプタの斜視図である。FIG. 12 is a perspective view of the adapter according to the second embodiment of the present invention connected to the port of the infusion bag. 図13は、図12の13-13線を含む面に沿った、本発明の実施形態2にかかるアダプタの断面図である。FIG. 13 is a cross-sectional view of the adapter according to the second embodiment of the present invention along the plane including lines 13-13 of FIG. 図14は、輸液バッグのポートの一例を示した斜視図である。FIG. 14 is a perspective view showing an example of a port of the infusion bag.
 上記の本発明のアダプタにおいて、前記複数の爪は、前記円に沿って不均一に配置されていてもよい。「不均一」とは、複数の爪が円に沿って等間隔で配置されていないこと、または、複数の爪が円の中心に対して等角度間隔で配置されていないことを意味する。かかる態様は、アダプタをメスコネクタに接続した状態でアダプタに外力(特に、輸液セットを介した引張り力)が加えられたときに、メスコネクタに対するアダプタの傾きを、限られた数の爪で効果的に抑えるのに有利である。 In the above adapter of the present invention, the plurality of claws may be unevenly arranged along the circle. “Non-uniform” means that the plurality of claws are not evenly spaced along the circle, or that the plurality of claws are not evenly spaced with respect to the center of the circle. In this aspect, when an external force (particularly, a tensile force via an infusion set) is applied to the adapter with the adapter connected to the female connector, the tilt of the adapter with respect to the female connector is effective with a limited number of claws. It is advantageous to suppress the target.
 前記穿刺針に対して前記円の中心が位置する側には、前記複数の爪及び前記複数のアームは配置されていなくてもよい。かかる態様は、アダプタをメスコネクタに接続するときに、穿刺針の先端とメスコネクタとを目視するのを容易にする。 The plurality of claws and the plurality of arms may not be arranged on the side where the center of the circle is located with respect to the puncture needle. Such an embodiment facilitates visual inspection of the tip of the puncture needle and the female connector when connecting the adapter to the female connector.
 本発明のアダプタは、前記穿刺針と前記混注ポートとの間の位置に外向きに突出した天板を更に備えていてもよい。前記天板に前記複数のアームが設けられていてもよい。前記穿刺針の長手方向に沿って見たとき、前記天板の、前記穿刺針に対して前記円の中心が位置する側の部分が切り欠かれていてもよい。かかる態様は、第1に、アダプタをメスコネクタに接続するときに、穿刺針の先端とメスコネクタとを目視するのを容易にし、第2に、アダプタをメスコネクタに接続した状態で、メスコネクタにシリンジの金属針等を穿刺するのを可能にする。 The adapter of the present invention may further include a top plate protruding outward at a position between the puncture needle and the mixed injection port. The plurality of arms may be provided on the top plate. When viewed along the longitudinal direction of the piercing needle, the portion of the top plate on the side where the center of the circle is located with respect to the piercing needle may be cut out. Such an embodiment makes it easy to visually recognize the tip of the puncture needle and the female connector when the adapter is connected to the female connector, and secondly, the female connector with the adapter connected to the female connector. Allows the metal needle of a syringe to be pierced.
 前記混注ポートは、前記円に対して、前記穿刺針が前記円に対して偏心するのと同じ側に偏心していてもよい。特に、前記混注ポートは、前記円に対して、前記穿刺針よりも更に大きく偏心していてもよい。かかる態様は、第1に、アダプタをメスコネクタに接続した状態で、メスコネクタにシリンジの金属針等を穿刺するのを容易にし、第2に、アダプタをメスコネクタに接続した状態でアダプタに引張り力が加えられたときに、メスコネクタに対するアダプタの傾きを抑えるのに有利である。 The mixed injection port may be eccentric to the circle on the same side as the puncture needle is eccentric to the circle. In particular, the mixed injection port may be more eccentric with respect to the circle than the puncture needle. In such an embodiment, firstly, it is easy to pierce the female connector with a metal needle of a syringe or the like while the adapter is connected to the female connector, and secondly, the adapter is pulled to the adapter while being connected to the female connector. It is advantageous to suppress the tilt of the adapter with respect to the female connector when a force is applied.
 前記複数のアームのそれぞれは、前記穿刺針と略平行に延びた第1弾性部及び第2弾性部を備えていてもよい。前記第1弾性部及び前記第2弾性部の先端側に前記爪が設けられていてもよい。前記第1弾性部及び前記第2弾性部は、前記円と同心の円に沿って配置されていてもよい。前記第1弾性部は、前記第2弾性部よりも、前記穿刺針に接近して配置されていてもよい。前記第1弾性部は、前記第2弾性部に比べて高強度であってもよい。かかる態様は、アダプタをメスコネクタに接続した状態でアダプタに引張り力が加えられたときに、メスコネクタに対する爪の係合が外れるのを防止するのに有利である。 Each of the plurality of arms may include a first elastic portion and a second elastic portion extending substantially parallel to the puncture needle. The claw may be provided on the tip side of the first elastic portion and the second elastic portion. The first elastic portion and the second elastic portion may be arranged along a circle concentric with the circle. The first elastic portion may be arranged closer to the puncture needle than the second elastic portion. The first elastic portion may have higher strength than the second elastic portion. Such an embodiment is advantageous in preventing the claw from being disengaged from the female connector when a tensile force is applied to the adapter with the adapter connected to the female connector.
 前記複数の爪のうち前記穿刺針から最も近い爪が設けられたアームは、他のアームに比べて高強度であってもよい。かかる態様は、アダプタをメスコネクタに接続した状態でアダプタに引張り力が加えられたときに、メスコネクタに対する爪の係合が外れるのを防止するのに有利である。 Of the plurality of claws, the arm provided with the claw closest to the puncture needle may have higher strength than the other arms. Such an embodiment is advantageous in preventing the claw from being disengaged from the female connector when a tensile force is applied to the adapter with the adapter connected to the female connector.
 以下に、本発明を好適な実施形態を示しながら詳細に説明する。但し、本発明は以下の実施形態に限定されないことはいうまでもない。以下の説明において参照する各図は、説明の便宜上、本発明の実施形態を構成する主要部材を簡略化して示したものである。従って、本発明は以下の各図に示されていない任意の部材を備え得る。また、本発明の範囲内において、以下の各図に示された各部材を変更または省略し得る。各実施形態の説明において引用する図面において、先行する実施形態で引用した図面に示された部材に対応する部材には、当該先行する実施形態の図面で付された符号と同じ符号が付してある。そのような部材については、重複する説明が省略されており、先行する実施形態の説明を適宜参酌すべきである。 The present invention will be described in detail below with reference to suitable embodiments. However, it goes without saying that the present invention is not limited to the following embodiments. For convenience of explanation, each figure referred to in the following description is a simplified representation of the main members constituting the embodiment of the present invention. Therefore, the present invention may include any member not shown in each of the following figures. Further, within the scope of the present invention, each member shown in each of the following figures may be changed or omitted. In the drawings cited in the description of each embodiment, the members corresponding to the members shown in the drawings cited in the preceding embodiments are designated by the same reference numerals as those assigned in the drawings of the preceding embodiments. is there. Overlapping description of such members has been omitted, and description of the preceding embodiments should be taken into account as appropriate.
 (実施形態1)
 図1及び図2は、本発明の実施形態1にかかるアダプタ1の斜視図である。図3は、図1の3-3線を含む面に沿ったアダプタ1の断面斜視図である。アダプタ1は、穿刺針10と、穿刺針10に向かって突出した2つの爪20と、2つの爪20が設けられた2つのアーム30と、混注ポート40とを備える。以下の説明の便宜のため、穿刺針10の長手方向を「上下方向」といい、穿刺針10の長手方向に直交する平面に平行な方向を「水平方向」という。上下方向において、混注ポート40の側を「上」側、穿刺針10の先端11の側を「下」側という。但し、「上下方向」、「上」、「下」、「水平方向」は、アダプタ1の実際の使用時の向きを意味するものではない。
(Embodiment 1)
1 and 2 are perspective views of the adapter 1 according to the first embodiment of the present invention. FIG. 3 is a cross-sectional perspective view of the adapter 1 along the surface including the 3-3 line of FIG. The adapter 1 includes a puncture needle 10, two claws 20 protruding toward the puncture needle 10, two arms 30 provided with the two claws 20, and a mixed injection port 40. For the convenience of the following description, the longitudinal direction of the puncture needle 10 is referred to as "vertical direction", and the direction parallel to the plane orthogonal to the longitudinal direction of the puncture needle 10 is referred to as "horizontal direction". In the vertical direction, the side of the mixed injection port 40 is referred to as the "upper" side, and the side of the tip 11 of the puncture needle 10 is referred to as the "lower" side. However, "vertical direction", "upper", "lower", and "horizontal direction" do not mean the orientation of the adapter 1 when it is actually used.
 穿刺針10は、まっすぐに延びた棒形状を有し、その先端11は鋭利に形成されている。穿刺針10内には、液体(例えば薬液)が流れる流路12が、穿刺針10の長手方向に沿って設けられている。穿刺針10の先端11近傍の外周面に2つの開口(横孔)13が設けられている。流路12は、開口13と連通し、開口13を介して外界と連通している。 The piercing needle 10 has a rod shape that extends straight, and its tip 11 is sharply formed. In the puncture needle 10, a flow path 12 through which a liquid (for example, a chemical solution) flows is provided along the longitudinal direction of the puncture needle 10. Two openings (horizontal holes) 13 are provided on the outer peripheral surface near the tip 11 of the puncture needle 10. The flow path 12 communicates with the opening 13 and communicates with the outside world through the opening 13.
 穿刺針10と混注ポート40との間の位置(または穿刺針10の基端)から、穿刺針10の長手方向に垂直な方向(即ち、半径方向)に沿って外向きに、天板35が延びている。天板35は、平面視形状(穿刺針10の長手方向に沿って見た形状)が略円形(または略円弧)の外周端縁を有する薄板である。天板35の外周端縁から2つのアーム30が、穿刺針10に対向するように下方に向かって延びている。各アーム30は、天板35から上下方向に沿って延びた2つの弾性部31と、2つの弾性部31の下端をつなぐ架橋部32とを含み、これらによって全体として略「U」字形状を有している。弾性部31は、細長い板状部材であり、その主面(面積が最大である面)は、穿刺針10と対向している。架橋部32は、水平面(水平方向に平行な面)に沿った略円弧形状を有している。アーム30と天板35とで、これらに囲まれた略矩形の開口33が形成され、当該開口33を介してアーム30より内側の穿刺針10を見通すことができる。 From the position between the puncture needle 10 and the mixed injection port 40 (or the base end of the puncture needle 10), the top plate 35 is outward along the direction perpendicular to the longitudinal direction (that is, the radial direction) of the puncture needle 10. It is extending. The top plate 35 is a thin plate having an outer peripheral edge having a substantially circular (or substantially arc) shape in a plan view (a shape viewed along the longitudinal direction of the piercing needle 10). Two arms 30 extend downward from the outer peripheral edge of the top plate 35 so as to face the puncture needle 10. Each arm 30 includes two elastic portions 31 extending in the vertical direction from the top plate 35 and a cross-linking portion 32 connecting the lower ends of the two elastic portions 31, thereby forming a substantially "U" shape as a whole. Have. The elastic portion 31 is an elongated plate-shaped member, and its main surface (the surface having the largest area) faces the puncture needle 10. The cross-linked portion 32 has a substantially arc shape along a horizontal plane (a plane parallel to the horizontal direction). A substantially rectangular opening 33 surrounded by the arm 30 and the top plate 35 is formed, and the puncture needle 10 inside the arm 30 can be seen through the opening 33.
 各アーム30の先端部分を構成する架橋部32に爪20が設けられている。爪20は、架橋部32の穿刺針10に対向する面から、穿刺針10に向かって突出している。爪20は、係止板22と、係止板22の下面に設けられたリブ23とを含む。係止板22は、略台形、略三角形、または略扇形を有する平板であって、先端21(穿刺針10に最も近い部分)に向かって天板35に接近するように傾斜している。係止板22の先端(即ち、爪20の先端)21は、円弧状に窪んでいる。リブ23は、係止板22の下面から下方に向かって突出した薄板状の突起である。リブ23の下側の端縁24は、円弧状に膨らんでおり、爪20の先端21と架橋部32の下端とをなめらかにつなぐ。 A claw 20 is provided on the cross-linked portion 32 that constitutes the tip portion of each arm 30. The claw 20 projects toward the puncture needle 10 from the surface of the cross-linking portion 32 facing the puncture needle 10. The claw 20 includes a locking plate 22 and a rib 23 provided on the lower surface of the locking plate 22. The locking plate 22 is a flat plate having a substantially trapezoidal shape, a substantially triangular shape, or a substantially fan shape, and is inclined toward the tip 21 (the portion closest to the puncture needle 10) so as to approach the top plate 35. The tip (that is, the tip of the claw 20) 21 of the locking plate 22 is recessed in an arc shape. The rib 23 is a thin plate-like protrusion protruding downward from the lower surface of the locking plate 22. The lower edge 24 of the rib 23 is bulged in an arc shape, and smoothly connects the tip 21 of the claw 20 and the lower end of the bridge portion 32.
 アーム30は、天板35との接続部分を固定端とする片持ち支持構造を有している。アーム30を構成する弾性部31は、比較的容易に弾性的に曲げ変形可能である。爪20は、アーム30の自由端に設けられている。従って、アーム30は、爪20が穿刺針10から離れるように弾性的に変形することができる。隣り合うアーム30間にスリット36が設けられているので、各アーム30は互いに独立して変形することができる。 The arm 30 has a cantilever support structure having a fixed end at a connecting portion with the top plate 35. The elastic portion 31 constituting the arm 30 can be elastically bent and deformed relatively easily. The claw 20 is provided at the free end of the arm 30. Therefore, the arm 30 can be elastically deformed so that the claw 20 is separated from the puncture needle 10. Since the slits 36 are provided between the adjacent arms 30, each arm 30 can be deformed independently of each other.
 混注ポート40は、略円筒形状を有する筒状部41と、筒状部41の上端に設けられた隔壁部材(以下「セプタム」という)45と、セプタム45にかぶせられたキャップ47とを備える。筒状部41内の内腔42は、穿刺針10内の流路12と連通している。セプタム45は、ゴム等の弾性材料からなり、円形の平面視形状を有する薄板である。セプタム45の中央に、セプタム45を上下方向に貫通する直線状のスリット(切り込み)46が形成されている。筒状部41の上端にセプタム45を載置し、セプタム45の上方からキャップ47を筒状部41に装着する。セプタム45は筒状部41とキャップ47とにより上下方向に挟持される。セプタム45のスリット46は、キャップ47の上面に形成された開口48内に露出する。セプタム45のスリット46に、鋭利な先端を有しない筒状のオス部材(図示せず)を挿入すると、セプタム45が弾性変形し、筒状部41内の内腔42とオス部材とが連通する。オス部材をセプタム45から引き抜くと、セプタム45は直ちに初期状態に復帰し、スリット46は液密に閉じられる。このように、セプタム45は、自閉式の弁として機能する。このような自閉式の混注ポート40は、「ニードルレスポート」とも呼ばれる。 The mixed injection port 40 includes a tubular portion 41 having a substantially cylindrical shape, a partition wall member (hereinafter referred to as “septum”) 45 provided at the upper end of the tubular portion 41, and a cap 47 covered with the septum 45. The lumen 42 in the tubular portion 41 communicates with the flow path 12 in the puncture needle 10. The septum 45 is a thin plate made of an elastic material such as rubber and having a circular plan view shape. A linear slit (cut) 46 that penetrates the septum 45 in the vertical direction is formed in the center of the septum 45. The septum 45 is placed on the upper end of the tubular portion 41, and the cap 47 is attached to the tubular portion 41 from above the septum 45. The septum 45 is sandwiched in the vertical direction by the tubular portion 41 and the cap 47. The slit 46 of the septum 45 is exposed in the opening 48 formed on the upper surface of the cap 47. When a tubular male member (not shown) having no sharp tip is inserted into the slit 46 of the septum 45, the septum 45 is elastically deformed and the cavity 42 in the tubular portion 41 and the male member communicate with each other. .. When the male member is pulled out from the septum 45, the septum 45 immediately returns to the initial state, and the slit 46 is closed liquid-tightly. In this way, the septum 45 functions as a self-closing valve. Such a self-closing mixed injection port 40 is also referred to as a "needleless port".
 図4は、穿刺針10の先端11側から、穿刺針10の長手方向に沿って見たアダプタ1の下面図である。2つの爪20の先端21の円弧は、二点鎖線で示した共通する円25に沿っている。点26は、円25の中心である。アーム30の架橋部32は、円25と同心の共通する円に沿っている。アーム30の弾性部31の主面は、円25と同心の共通する円に接している。天板35(図1、図2参照)の外周端縁も、円25と同心の円に沿っている。一方、穿刺針10は、円25の中心26から外れた位置にある。即ち、穿刺針10は、爪20の先端21に内接する円25に対して偏心している。本発明では、円25の中心26に対して穿刺針10が位置する側を「偏心側」(図4において、矢印D1が向く側)といい、円25の中心26に対して穿刺針10が位置する側とは反対側(即ち、穿刺針10に対して円25の中心26が位置する側)を「反偏心側」(図4において、矢印D2が向く側)という。穿刺針10は、円25の内側に位置している。中心26と穿刺針10の中心軸(図示せず。中心軸は、先端11を通り、穿刺針10の長手方向に沿って延びる。)とを含む面Sを「偏心方向面」という。図3の断面は、偏心方向面Sと一致する。穿刺針10から爪20(特にその先端21)までの距離が偏心側D1において短くなるように、爪20が配置されている。爪20は、円25に沿って不均一に配置されている。中心26(または穿刺針10)に対して反偏心側D2には、爪20及びアーム30は配置されていない。天板35には、反偏心側D2の端縁から穿刺針10の基端近傍にまで達する切り欠き37が設けられている(図1参照)。アダプタ1は、偏心方向面Sに対して対称である。 FIG. 4 is a bottom view of the adapter 1 viewed from the tip 11 side of the puncture needle 10 along the longitudinal direction of the puncture needle 10. The arc of the tip 21 of the two claws 20 is along the common circle 25 indicated by the alternate long and short dash line. The point 26 is the center of the circle 25. The cross-linked portion 32 of the arm 30 is along a common circle concentric with the circle 25. The main surface of the elastic portion 31 of the arm 30 is in contact with a common circle concentric with the circle 25. The outer peripheral edge of the top plate 35 (see FIGS. 1 and 2) is also along a circle concentric with the circle 25. On the other hand, the puncture needle 10 is located off the center 26 of the circle 25. That is, the piercing needle 10 is eccentric with respect to the circle 25 inscribed in the tip 21 of the claw 20. In the present invention, the side where the puncture needle 10 is located with respect to the center 26 of the circle 25 is referred to as the "eccentric side" (the side facing the arrow D1 in FIG. 4), and the puncture needle 10 is located with respect to the center 26 of the circle 25. The side opposite to the position side (that is, the side where the center 26 of the circle 25 is located with respect to the puncture needle 10) is referred to as the "anti-eccentric side" (the side in which the arrow D2 faces in FIG. 4). The puncture needle 10 is located inside the circle 25. The surface S including the center 26 and the central axis of the puncture needle 10 (not shown. The central axis passes through the tip 11 and extends along the longitudinal direction of the puncture needle 10) is referred to as an "eccentric direction surface". The cross section of FIG. 3 coincides with the eccentric direction plane S. The claw 20 is arranged so that the distance from the piercing needle 10 to the claw 20 (particularly the tip 21 thereof) is shortened on the eccentric side D1. The claws 20 are unevenly arranged along the circle 25. The claw 20 and the arm 30 are not arranged on the anti-eccentric side D2 with respect to the center 26 (or the puncture needle 10). The top plate 35 is provided with a notch 37 extending from the edge of the anti-eccentric side D2 to the vicinity of the proximal end of the puncture needle 10 (see FIG. 1). The adapter 1 is symmetrical with respect to the eccentric plane S.
 アダプタ1の、セプタム45及びキャップ47を除く部分は、樹脂材料を射出成形することにより全体を一部品として一体的に製造されることが好ましい。使用できる樹脂材料は、制限はないが、ポリエチレン、ポリプロピレン、ポリカーボネート、スチレンエチレン、ポリエチレンテレフタレート、ポリブチレンテレフタレート、ブチレンスチレンブロック共重合体などを例示することができるが、医療用に用いられることやアーム30が弾性曲げ変形されることを考慮すると、ポリエチレン、ポリプロピレンなどのポリオレフィン系樹脂が好ましい。キャップ47の材料は、制限はないが、硬質の材料であることが好ましく、例えば、ポリカーボネート、ポリプロピレン、ポリアセタール、ポリアミド、硬質ポリ塩化ビニル、ポリエチレン等の樹脂材料を用いることができる。セプタム45の材料は、制限はないが、ゴム弾性を有する軟質の材料であることが好ましく、例えば、イソプレンゴム、シリコーンゴム、ブチルゴム等のゴム材料や、熱可塑性エラストマー等を用いることができる。 It is preferable that the portion of the adapter 1 excluding the septum 45 and the cap 47 is integrally manufactured as one part by injection molding a resin material. The resin material that can be used is not limited, and examples thereof include polyethylene, polypropylene, polycarbonate, styrene ethylene, polyethylene terephthalate, polybutylene terephthalate, and butylene styrene block copolymer, but those used for medical purposes and arms. Considering that 30 is elastically bent and deformed, polyolefin resins such as polyethylene and polypropylene are preferable. The material of the cap 47 is not limited, but is preferably a hard material, and for example, a resin material such as polycarbonate, polypropylene, polyacetal, polyamide, hard polyvinyl chloride, and polyethylene can be used. The material of the septum 45 is not limited, but is preferably a soft material having rubber elasticity, and for example, a rubber material such as isoprene rubber, silicone rubber, or butyl rubber, a thermoplastic elastomer, or the like can be used.
 アダプタ1の使用方法の一例を説明する。 An example of how to use the adapter 1 will be explained.
 最初に、図5に示すように、アダプタ1を、輸液バッグのポート(メスコネクタ)90に対向させる。ポート90は、図14に示したものと同じである。輸液バッグは、ポート90と、ポート90の基端99に取り付けらた柔軟な袋状のバッグ本体を備える。図14と同様に、図5においても、バッグ本体の図示を省略している。ポート90の上方を向いた開口95がゴム栓91で封止されている。輸液バッグには、ゴム栓91の領域92にシリンジの金属針を穿刺して所定の薬剤等が既に注入されている。従って、領域92には金属針による穿刺孔(穿刺痕)92aが形成されている。金属針を抜き去るとゴム栓91は弾性回復するので、図5の状態では穿刺孔92aは実質的に閉じている。 First, as shown in FIG. 5, the adapter 1 is made to face the port (female connector) 90 of the infusion bag. The port 90 is the same as that shown in FIG. The infusion bag includes a port 90 and a flexible bag-shaped bag body attached to the base end 99 of the port 90. Similar to FIG. 14, in FIG. 5, the bag body is not shown. The upwardly facing opening 95 of the port 90 is sealed with a rubber stopper 91. A predetermined drug or the like has already been injected into the infusion bag by puncturing the area 92 of the rubber stopper 91 with a metal needle of a syringe. Therefore, a puncture hole (puncture mark) 92a by a metal needle is formed in the region 92. Since the rubber stopper 91 elastically recovers when the metal needle is removed, the puncture hole 92a is substantially closed in the state of FIG.
 ポート90にアダプタ1を接近させ、穿刺針10をゴム栓91の領域93に穿刺する。 The adapter 1 is brought close to the port 90, and the puncture needle 10 is punctured into the area 93 of the rubber stopper 91.
 アダプタ1をポート90に向かって押し込むと、穿刺針10がゴム栓91に挿入され、これと並行して、爪20に一体的に設けられたリブ23の端縁24(図3参照)がポート90の上側端縁96上を摺動する。端縁24は、上側端縁96上を摺動しながら、爪20を穿刺針10から離れる向き(外側)に移動させる。爪20の移動にしたがって、アーム30の弾性部31が弾性的に曲げ変形する。更に、アダプタ1をポート90に向かって押し込む。爪20の先端21がポート90の段差97を越えると、弾性部31は弾性回復し、爪20は、相対的に小さな外径の径小部98に嵌入する。爪20は、径小部98に隣接する段差97に係合する。 When the adapter 1 is pushed toward the port 90, the piercing needle 10 is inserted into the rubber stopper 91, and in parallel with this, the end edge 24 (see FIG. 3) of the rib 23 integrally provided on the claw 20 is ported. It slides on the upper edge 96 of 90. The edge 24 moves the claw 20 away from the puncture needle 10 (outside) while sliding on the upper edge 96. As the claw 20 moves, the elastic portion 31 of the arm 30 elastically bends and deforms. Further, the adapter 1 is pushed toward the port 90. When the tip 21 of the claw 20 exceeds the step 97 of the port 90, the elastic portion 31 elastically recovers, and the claw 20 fits into the small diameter portion 98 having a relatively small outer diameter. The claw 20 engages with a step 97 adjacent to the small diameter portion 98.
 かくして、図6に示すように、アダプタ1をポート90に接続することができる。図7は、図6の7-7線を含む面(偏心方向面)に沿った断面図である。2つの爪20(図1~図5参照)は、ポート90の径小部98を挟持する。爪20は、ポート90の中心軸(図示せず)と同心の円にほぼ沿っている。2つの爪20は、それぞれポート90に安定的に係合する。アダプタ1及びポート90に、両者を引き離す向きの力が加えられても、ポート90に対する爪20の係合は外れない。 Thus, as shown in FIG. 6, the adapter 1 can be connected to the port 90. FIG. 7 is a cross-sectional view taken along a plane (eccentric direction plane) including the line 7-7 of FIG. The two claws 20 (see FIGS. 1 to 5) sandwich the small diameter portion 98 of the port 90. The claw 20 is substantially along a circle concentric with the central axis (not shown) of the port 90. The two claws 20 each stably engage the port 90. Even if a force is applied to the adapter 1 and the port 90 in a direction to separate them, the engagement of the claw 20 with the port 90 is not disengaged.
 アーム30は、ポート90の外径に応じて適宜変形可能である。アダプタ1は、外径が異なる複数種類のポート90に接続することができる。 The arm 30 can be appropriately deformed according to the outer diameter of the port 90. The adapter 1 can be connected to a plurality of types of ports 90 having different outer diameters.
 穿刺針10は、爪20の内接円25に対して偏心している(図4参照)。このため、爪20がポート90に係合したとき、穿刺針10は、ゴム栓91の中央から外れた領域93を、ゴム栓91の表面に対して垂直に(あるいは、ポート90の中心軸に平行に)穿刺する。 The puncture needle 10 is eccentric with respect to the inscribed circle 25 of the nail 20 (see FIG. 4). Therefore, when the claw 20 engages with the port 90, the puncture needle 10 makes the region 93 off the center of the rubber stopper 91 perpendicular to the surface of the rubber stopper 91 (or on the central axis of the port 90). Puncture (in parallel).
 上述したように、従来のアダプタでは、穿刺針の長手方向に沿って見たとき、複数の爪の先端に内接する円の中心に穿刺針が配置されていた。このため、ポート90に複数の爪を正しく係合させるためには、穿刺針をゴム栓91の中央に穿刺する必要があった。ゴム栓91の中央は、領域92に既に形成された金属針による穿刺孔92aから近いので、穿刺針がゴム栓91を穿刺することによって穿刺孔92aが拡大して輸液バッグ内の薬液が漏れ出るという問題が生じる。一方、穿刺針をゴム栓91の中央から外れた領域93に無理に穿刺しようとすると、(1)複数の爪の全てをポート90に係合させることができない、(2)爪が設けられたアームや穿刺針に曲げ力が作用してこれらが破損する、(3)ゴム栓91を斜めに穿刺した穿刺針10がゴム栓91を大きく変形させ、拡大された穿刺孔92aを通って、または、穿刺針10とゴム栓91との間の隙間を通って、薬液が漏れ出る、等の問題が発生する。 As described above, in the conventional adapter, the puncture needle is arranged at the center of the circle inscribed in the tips of a plurality of nails when viewed along the longitudinal direction of the puncture needle. Therefore, in order to properly engage the plurality of claws with the port 90, it is necessary to puncture the puncture needle in the center of the rubber stopper 91. Since the center of the rubber stopper 91 is close to the puncture hole 92a by the metal needle already formed in the region 92, the puncture hole 92a expands when the puncture needle pierces the rubber stopper 91, and the drug solution in the infusion bag leaks out. The problem arises. On the other hand, when an attempt is made to forcibly puncture the puncture needle into the region 93 off the center of the rubber stopper 91, (1) all of the plurality of claws cannot be engaged with the port 90, and (2) the claws are provided. Bending force acts on the arm and the puncture needle to damage them. (3) The puncture needle 10 that punctures the rubber stopper 91 at an angle greatly deforms the rubber stopper 91 and passes through the enlarged puncture hole 92a or , The chemical liquid leaks through the gap between the puncture needle 10 and the rubber stopper 91, and the like occurs.
 本実施形態1のアダプタ1は、従来のアダプタの上記の問題を解消することができる。本実施形態1によれば、穿刺針10を、ゴム栓91の中央から外れた領域93に、ゴム栓91に対して傾くことなく穿刺することができる。領域93は領域92から離れている。このため、領域92に金属針による穿刺孔92aが形成されていても、穿刺針10をゴム栓91に穿刺したことによって穿刺孔92aが拡大されて薬液が漏れ出るという事態は生じない。 The adapter 1 of the first embodiment can solve the above-mentioned problems of the conventional adapter. According to the first embodiment, the puncture needle 10 can puncture the region 93 off the center of the rubber stopper 91 without tilting with respect to the rubber stopper 91. Region 93 is separated from Region 92. Therefore, even if the puncture hole 92a by the metal needle is formed in the region 92, the puncture hole 92a is not expanded by puncturing the rubber stopper 91 with the puncture needle 10, and the drug solution does not leak out.
 図6及び図7のようにポート90にアダプタ1を接続した後、アダプタ1の混注ポート40に、輸液セットの上流端のオスコネクタ(図示せず)を接続する。オスコネクタは、セプタム45のスリット46に挿入されるオス部材と、混注ポート40に係合する爪とを備える(例えば特許文献3参照)。アダプタ1の爪20がポート90に係合し、オスコネクタの爪が混注ポート40に係合する。このため、輸液セットに引張り力が加えられても、ポート90、アダプタ1、オスコネクタ間の接続は維持される。 After connecting the adapter 1 to the port 90 as shown in FIGS. 6 and 7, connect the male connector (not shown) at the upstream end of the infusion set to the mixed injection port 40 of the adapter 1. The male connector includes a male member inserted into the slit 46 of the septum 45 and a claw that engages with the mixed injection port 40 (see, for example, Patent Document 3). The claw 20 of the adapter 1 engages the port 90, and the claw of the male connector engages the mixed injection port 40. Therefore, even if a tensile force is applied to the infusion set, the connection between the port 90, the adapter 1, and the male connector is maintained.
 天板35には切り欠き37が形成されている。切り欠き37は、天板35の反偏心側D2の端縁から穿刺針10に向かって設けられている。切り欠き37は、以下の作用をもたらす。第1に、図5及び図6から理解できるように、アダプタ1をポート90に接続するときには、穿刺針10の先端11とゴム栓91の上面(特に領域93)とを、切り欠き37を介して目視することができる。これは、穿刺針10をゴム栓91の領域93に正確に穿刺するのに有利である。第2に、図6及び図7に示されているように、アダプタ1をポート90に接続した後は、ゴム栓91の上面(特に領域92)が、切り欠き37を介して露出される。これは、アダプタ1をポート90に接続した状態で、ゴム栓91の領域92にシリンジの金属針を穿刺して輸液バッグに薬剤等を含む液体を注入して輸液バッグ内で薬液を調製できるという、従来のアダプタでは不可能であった操作を可能にする。 A notch 37 is formed on the top plate 35. The notch 37 is provided from the edge of the anti-eccentric side D2 of the top plate 35 toward the piercing needle 10. The notch 37 has the following effects. First, as can be seen from FIGS. 5 and 6, when the adapter 1 is connected to the port 90, the tip 11 of the puncture needle 10 and the upper surface (particularly the region 93) of the rubber stopper 91 are connected through the notch 37. Can be visually observed. This is advantageous for accurately puncturing the puncture needle 10 into the region 93 of the rubber stopper 91. Second, as shown in FIGS. 6 and 7, after the adapter 1 is connected to the port 90, the upper surface (particularly the region 92) of the rubber stopper 91 is exposed through the notch 37. This means that with the adapter 1 connected to the port 90, a metal needle of a syringe can be pierced into the region 92 of the rubber stopper 91 to inject a liquid containing a drug or the like into the infusion bag to prepare a drug solution in the infusion bag. , Enables operations that were not possible with conventional adapters.
 天板35の切り欠き37が設けられた部分には、アーム30は設けられていない。このため、穿刺針10に対して内接円25の中心26が位置する側(反偏心側D2)には、爪20及びアーム30は配置されていない。これは、アダプタ1をポート90に接続するときに、穿刺針10の先端11とゴム栓91の上面(特に領域93)とを、反偏心側D2から目視するのを容易にする(図5、図6参照)。 The arm 30 is not provided in the portion of the top plate 35 where the notch 37 is provided. Therefore, the claw 20 and the arm 30 are not arranged on the side (anti-eccentric side D2) where the center 26 of the inscribed circle 25 is located with respect to the puncture needle 10. This makes it easy to visually recognize the tip 11 of the puncture needle 10 and the upper surface (particularly the region 93) of the rubber stopper 91 from the anti-eccentric side D2 when the adapter 1 is connected to the port 90 (FIG. 5, FIG. (See FIG. 6).
 図7に示されているように、混注ポート40は、爪20の内接円25(図4参照)に対して、穿刺針10が偏心するのと同じ側(偏心側D1)に偏心している。特に、混注ポート40は、内接円25に対して、穿刺針10よりも更に大きく偏心側D1に偏心している。このため、混注ポート40が穿刺針10よりも大径であっても、天板35に形成された切り欠き37に対して、混注ポート40が上下方向に実質的に重ならない。切り欠き37は、混注ポート40によって塞がれることなく、上方に向かって開放される。これは、アダプタ1をポート90に接続した状態(図6、図7参照)でゴム栓91の領域92にシリンジの金属針を穿刺するとき、シリンジやその金属針が混注ポート40に衝突するのを回避するのに有利である。 As shown in FIG. 7, the mixed injection port 40 is eccentric to the inscribed circle 25 (see FIG. 4) of the claw 20 on the same side (eccentric side D1) as the puncture needle 10 is eccentric. .. In particular, the mixed injection port 40 is more eccentric to the eccentric side D1 with respect to the inscribed circle 25 than the puncture needle 10. Therefore, even if the mixed injection port 40 has a diameter larger than that of the puncture needle 10, the mixed injection port 40 does not substantially overlap the notch 37 formed in the top plate 35 in the vertical direction. The notch 37 is opened upward without being blocked by the mixed injection port 40. This is because the syringe and its metal needle collide with the mixed injection port 40 when the metal needle of the syringe is punctured in the region 92 of the rubber stopper 91 with the adapter 1 connected to the port 90 (see FIGS. 6 and 7). It is advantageous to avoid.
 図4に示したように、隣り合う爪20間の周方向に沿った間隔が、偏心側D1で狭く、且つ、反偏心側D2で広くなるように、爪20は、内接円25に沿って不均一に配置されている。即ち、穿刺針10から爪20(特に、その先端21)までの距離が相対的に短い偏心側D1において、爪20間の間隔が狭い。このように穿刺針10の近くに爪20が密に配置されていることは、アダプタ1をポート90に接続した状態において外力がアダプタ1に加えられたとき、アダプタ1のポート90に対する傾きを抑えるのに有利である。 As shown in FIG. 4, the claws 20 are along the inscribed circle 25 so that the distance between the adjacent claws 20 along the circumferential direction is narrow on the eccentric side D1 and wide on the anti-eccentric side D2. Is unevenly arranged. That is, on the eccentric side D1 where the distance from the puncture needle 10 to the claw 20 (particularly, the tip 21 thereof) is relatively short, the distance between the claws 20 is narrow. The fact that the claws 20 are densely arranged near the piercing needle 10 in this way suppresses the inclination of the adapter 1 with respect to the port 90 when an external force is applied to the adapter 1 while the adapter 1 is connected to the port 90. It is advantageous for.
 輸液セットに加えられた引張り力は、図7の矢印Fのように、混注ポート40に上向きに作用する。引張り力Fは、爪20とポート90との係合箇所を支点とする回転モーメントを発生させる。回転モーメントの大きさは、混注ポート40から爪20までの水平方向距離に依存する。本実施形態1では、上述したように、混注ポート40は、内接円25に対して偏心側D1に(好ましくは穿刺針10よりも大きく)偏心している。これは、混注ポート40と爪20との間の水平方向距離を短くする。このため、回転モーメントが小さくなる。これは、アダプタ1に引張り力Fが加えられたとき、ポート90に対するアダプタ1の傾きを小さくするのに有利である。アダプタ1がポート90に対して傾くと、ポート90に対する爪20の係合が外れる、穿刺針10がゴム栓91に対して傾くことによって穿刺針10とゴム栓91との間に隙間が形成され、この隙間を通って薬液バッグ内の薬液が外界に漏れ出る、等の問題が生じる可能性がある。本実施形態1では、このような問題が生じにくい。 The tensile force applied to the infusion set acts upward on the mixed injection port 40 as shown by the arrow F in FIG. The tensile force F generates a rotational moment with the engagement point between the claw 20 and the port 90 as a fulcrum. The magnitude of the rotational moment depends on the horizontal distance from the mixed injection port 40 to the claw 20. In the first embodiment, as described above, the mixed injection port 40 is eccentric to the eccentric side D1 (preferably larger than the puncture needle 10) with respect to the inscribed circle 25. This shortens the horizontal distance between the mixed injection port 40 and the claw 20. Therefore, the rotational moment becomes small. This is advantageous for reducing the inclination of the adapter 1 with respect to the port 90 when a tensile force F is applied to the adapter 1. When the adapter 1 is tilted with respect to the port 90, the claw 20 is disengaged from the port 90. The puncture needle 10 is tilted with respect to the rubber stopper 91 to form a gap between the puncture needle 10 and the rubber stopper 91. , The chemical solution in the chemical solution bag leaks to the outside through this gap, and the like may occur. In the first embodiment, such a problem is unlikely to occur.
 隣り合うアーム30間のスリット36は、天板35にまで達していない(図2参照)。各アーム30を構成する2つの弾性部31(31a,31b)のうち、スリット36に隣接する第1弾性部31aは、第2弾性部31bに比べて短い。このため、第1弾性部31aは、第2弾性部31bよりも高強度で曲げ変形しにくい。穿刺針10の長手方向に沿って見たとき、相対的に高強度の第1弾性部31aが、第2弾性部31bよりも穿刺針10(または混注ポート40)に接近して配置されている(図1~図4参照)。これは、引張り力Fが加えられたときに、ポート90に対する爪20の係合が外れるのを防止するのに有利である。この理由は以下の通りである。引張り力Fは、混注ポート40に、アダプタ1をポート90から穿刺針10の長手方向に沿って引き離すように作用する(図7参照)。この引張り力Fに対して、2つの弾性部31a,31bのうち、穿刺針10及び混注ポート40により近い第1弾性部31aが主として対抗する。第1弾性部31aが相対的に高強度であることは、混注ポート40に引張り力Fが加えられたときの第1弾性部31aの変形を小さくする。このため、ポート90に対する爪20の係合が外れにくくなるのである。一方、第2弾性部31bが相対的に低強度であることは、アダプタ1をポート90に接続する作業を容易にする。 The slit 36 between the adjacent arms 30 does not reach the top plate 35 (see FIG. 2). Of the two elastic portions 31 (31a, 31b) constituting each arm 30, the first elastic portion 31a adjacent to the slit 36 is shorter than the second elastic portion 31b. Therefore, the first elastic portion 31a has higher strength than the second elastic portion 31b and is less likely to be bent and deformed. When viewed along the longitudinal direction of the puncture needle 10, the relatively high-strength first elastic portion 31a is arranged closer to the puncture needle 10 (or mixed injection port 40) than the second elastic portion 31b. (See FIGS. 1 to 4). This is advantageous in preventing the claw 20 from being disengaged from the port 90 when a tensile force F is applied. The reason for this is as follows. The tensile force F acts on the mixed injection port 40 to pull the adapter 1 away from the port 90 along the longitudinal direction of the puncture needle 10 (see FIG. 7). Of the two elastic portions 31a and 31b, the first elastic portion 31a, which is closer to the puncture needle 10 and the mixed injection port 40, mainly opposes the tensile force F. The relatively high strength of the first elastic portion 31a reduces the deformation of the first elastic portion 31a when a tensile force F is applied to the mixed injection port 40. Therefore, the engagement of the claw 20 with the port 90 is difficult to be disengaged. On the other hand, the relatively low strength of the second elastic portion 31b facilitates the work of connecting the adapter 1 to the port 90.
 なお、第1弾性部31aを第2弾性部31bより高強度にする方法は、本実施形態1に限定されず、任意である。例えば、第1弾性部31aの断面積を大きくする、第1弾性部31aに補強用のリブを設ける、等の方法により、第1弾性部31aを相対的に高強度にしてもよい。本実施形態1とは異なり、本発明では、第1弾性部31aと第2弾性部31bとが実質的に同じ強度を有していてもよい。 The method of making the first elastic portion 31a stronger than the second elastic portion 31b is not limited to the first embodiment and is arbitrary. For example, the first elastic portion 31a may have a relatively high strength by increasing the cross-sectional area of the first elastic portion 31a, providing a rib for reinforcement in the first elastic portion 31a, or the like. Unlike the first embodiment, in the present invention, the first elastic portion 31a and the second elastic portion 31b may have substantially the same strength.
 本実施形態1のアダプタ1では、穿刺針10をゴム栓91の中央に穿刺することは困難である。しかしながら、これは輸液を行うに際して何の問題も生じさせない。 With the adapter 1 of the first embodiment, it is difficult to puncture the puncture needle 10 in the center of the rubber stopper 91. However, this does not cause any problems when infusing.
 (実施形態2)
 図8及び図9は、本発明の実施形態2にかかるアダプタ2の斜視図である。図10は、図8の10-10線を含む面(偏心方向面)に沿ったアダプタ2の断面斜視図である。本実施形態2のアダプタ2は、穿刺針10に向かって突出した3つの爪220と、3つの爪220が設けられた3つのアーム230とを備える点で、2つの爪20と2つのアーム30とを備える実施形態1のアダプタ1と異なる。以下、実施形態1と異なる点を中心に、本実施形態2のアダプタ2を説明する。
(Embodiment 2)
8 and 9 are perspective views of the adapter 2 according to the second embodiment of the present invention. FIG. 10 is a cross-sectional perspective view of the adapter 2 along the surface (eccentric direction surface) including the line 10-10 of FIG. The adapter 2 of the second embodiment has two claws 20 and two arms 30 in that it includes three claws 220 protruding toward the puncture needle 10 and three arms 230 provided with the three claws 220. It is different from the adapter 1 of the first embodiment including. Hereinafter, the adapter 2 of the second embodiment will be described with a focus on the differences from the first embodiment.
 以下の説明において、3つの爪220及び3つのアーム230を区別する必要がある場合には、図8及び図9に示されているように、それらの符号に添え字「a」、「b」、または「c」を付す。爪220bと爪220cとの間に爪220aが配置されている。爪220a,220b,220cは、アーム230a,230b,230cにそれぞれ設けられている。 In the following description, when it is necessary to distinguish between the three claws 220 and the three arms 230, the subscripts "a" and "b" are added to their symbols as shown in FIGS. 8 and 9. , Or "c". The claw 220a is arranged between the claw 220b and the claw 220c. The claws 220a, 220b, 220c are provided on the arms 230a, 230b, 230c, respectively.
 天板35の外周端縁から3つのアーム230が、穿刺針10に対向するように下方に向かって延びている。実施形態1のアーム30と同様に、各アーム230は、天板35から上下方向に沿って延びた2つの弾性部31と、2つの弾性部31の下端をつなぐ架橋部32とを含み、これらによって全体として略「U」字形状を有している。 Three arms 230 extend downward from the outer peripheral edge of the top plate 35 so as to face the puncture needle 10. Similar to the arm 30 of the first embodiment, each arm 230 includes two elastic portions 31 extending in the vertical direction from the top plate 35 and a bridging portion 32 connecting the lower ends of the two elastic portions 31. As a whole, it has a substantially "U" shape.
 アーム230の先端部分を構成する架橋部32に爪220が設けられている。爪220は、架橋部32の穿刺針10に対向する面から、穿刺針10に向かって突出している。実施形態1の爪20と同様に、各爪220は、係止板22と、係止板22の下面に設けられたリブ23とを含む。中央の爪220aには2つのリブ23が設けられ、その両側の爪220b,230cには1つのリブ23が設けられている。 A claw 220 is provided on the cross-linked portion 32 forming the tip portion of the arm 230. The claw 220 protrudes toward the piercing needle 10 from the surface of the bridging portion 32 facing the piercing needle 10. Similar to the claw 20 of the first embodiment, each claw 220 includes a locking plate 22 and a rib 23 provided on the lower surface of the locking plate 22. Two ribs 23 are provided on the central claw 220a, and one rib 23 is provided on the claws 220b and 230c on both sides thereof.
 アーム230は、爪220が穿刺針10から離れるように弾性的に変形することができる。アーム230aとアーム230bとの間、及び、アーム230aとアーム230cとの間に、それぞれスリット36が設けられているので、各アーム230a,230b,230cは互いに独立して変形することができる。 The arm 230 can be elastically deformed so that the claw 220 is separated from the puncture needle 10. Since the slits 36 are provided between the arm 230a and the arm 230b and between the arm 230a and the arm 230c, the arms 230a, 230b, and 230c can be deformed independently of each other.
 図11は、穿刺針10の先端11側から、穿刺針10の長手方向に沿って見たアダプタ2の下面図である。実施形態1と同様に、3つの爪220の先端21の円弧は、二点鎖線で示した共通する円25に沿っている。アーム230の架橋部32は、円25と同心の共通する円に沿っている。アーム230の弾性部31の主面は、円25と同心の共通する円に接している。天板35(図8、図9参照)の外周端縁も、円25と同心の円に沿っている。一方、穿刺針10は、円25に対して偏心側D1に偏心している。爪220は、円25に沿って不均一に配置されている。中心26(または穿刺針10)に対して反偏心側D2には、爪220及びアーム230は配置されていない。天板35には、反偏心側D2の端縁から穿刺針10の基端近傍にまで達する切り欠き37が設けられている。アダプタ2は、偏心方向面Sに対して対称である。中央の爪220aは、偏心方向面S上に位置する。 FIG. 11 is a bottom view of the adapter 2 as viewed from the tip 11 side of the puncture needle 10 along the longitudinal direction of the puncture needle 10. Similar to the first embodiment, the arc of the tip 21 of the three claws 220 is along the common circle 25 indicated by the two-point chain line. The cross-linked portion 32 of the arm 230 is along a common circle concentric with the circle 25. The main surface of the elastic portion 31 of the arm 230 is in contact with a common circle concentric with the circle 25. The outer peripheral edge of the top plate 35 (see FIGS. 8 and 9) is also along a circle concentric with the circle 25. On the other hand, the puncture needle 10 is eccentric to the eccentric side D1 with respect to the circle 25. The claws 220 are unevenly arranged along the circle 25. The claw 220 and the arm 230 are not arranged on the anti-eccentric side D2 with respect to the center 26 (or the piercing needle 10). The top plate 35 is provided with a notch 37 extending from the edge of the anti-eccentric side D2 to the vicinity of the proximal end of the puncture needle 10. The adapter 2 is symmetrical with respect to the eccentric plane S. The central claw 220a is located on the eccentric direction surface S.
 アダプタ2は、実施形態1のアダプタ1と同様に、輸液バッグのポート90に接続される。図12はポート90に接続されたアダプタ2の斜視図である。図13は、図12の13-13線を含む面(偏心方向面)に沿った断面図である。 The adapter 2 is connected to the port 90 of the infusion bag in the same manner as the adapter 1 of the first embodiment. FIG. 12 is a perspective view of the adapter 2 connected to the port 90. FIG. 13 is a cross-sectional view taken along a plane (eccentric direction plane) including lines 13-13 of FIG.
 3つの爪220が、ポート90の段差97に係合し、径小部98を挟持する。爪220は、ポート90の中心軸(図示せず)と同心の円にほぼ沿っている。3つの爪220は、それぞれポート90に安定的に係合する。アダプタ2及びポート90に、両者を引き離す向きの力が加えられても、ポート90に対する爪220の係合は外れない。 The three claws 220 engage with the step 97 of the port 90 and sandwich the small diameter portion 98. The claw 220 is substantially along a circle concentric with the central axis (not shown) of the port 90. Each of the three claws 220 is stably engaged with the port 90. Even if a force is applied to the adapter 2 and the port 90 in a direction to separate them, the engagement of the claw 220 with the port 90 is not disengaged.
 穿刺針10は、ゴム栓91の中央から外れた領域93を、ゴム栓91の表面に対して垂直に(あるいは、ポート90の中心軸に平行に)穿刺している。ゴム栓91の領域92に金属針による穿刺孔92aが形成されていても、穿刺針10を領域93に穿刺したことによって穿刺孔92aが拡大されて薬液が漏れ出るという事態は生じない。 The puncture needle 10 punctures the region 93 off the center of the rubber stopper 91 perpendicularly to the surface of the rubber stopper 91 (or parallel to the central axis of the port 90). Even if the puncture hole 92a by the metal needle is formed in the region 92 of the rubber stopper 91, the puncture hole 92a is not expanded by puncturing the region 93 with the puncture needle 10 and the drug solution does not leak out.
 実施形態1と同様に、図12及び図13のようにポート90にアダプタ2を接続した後、アダプタ2の混注ポート40に、輸液セットの上流端のオスコネクタ(図示せず)を接続する。 Similar to the first embodiment, after connecting the adapter 2 to the port 90 as shown in FIGS. 12 and 13, a male connector (not shown) at the upstream end of the infusion set is connected to the mixed injection port 40 of the adapter 2.
 図11に示したように、隣り合う爪220間の周方向に沿った間隔が、偏心側D1で狭く、且つ、反偏心側D2で広くなるように、爪220は、内接円25に沿って不均一に配置されている。特に、穿刺針10に対して偏心側D1に位置する爪220aは、穿刺針10に最も接近して配置されている。このような爪220の配置は、アダプタ2をポート90に接続した状態において外力がアダプタ2に加えられたとき、アダプタ2のポート90に対する傾きを抑えるのに有利である。 As shown in FIG. 11, the claw 220 is along the inscribed circle 25 so that the distance between adjacent claws 220 along the circumferential direction is narrow on the eccentric side D1 and wide on the anti-eccentric side D2. Is unevenly arranged. In particular, the claw 220a located on the eccentric side D1 with respect to the piercing needle 10 is arranged closest to the piercing needle 10. Such an arrangement of the claws 220 is advantageous in suppressing the inclination of the adapter 2 with respect to the port 90 when an external force is applied to the adapter 2 while the adapter 2 is connected to the port 90.
 実施形態1と同様に、混注ポート40は、内接円25に対して偏心側D1に(好ましくは穿刺針10よりも大きく)偏心している。このため、混注ポート40から爪220(特に爪220a)までの水平方向距離が短い。これは、アダプタ2に引張り力F(図13参照)が加えられたときの、ポート90に対するアダプタ2の傾きを抑えるのに有利である。 Similar to the first embodiment, the mixed injection port 40 is eccentric to the eccentric side D1 (preferably larger than the puncture needle 10) with respect to the inscribed circle 25. Therefore, the horizontal distance from the mixed injection port 40 to the claw 220 (particularly the claw 220a) is short. This is advantageous in suppressing the inclination of the adapter 2 with respect to the port 90 when a tensile force F (see FIG. 13) is applied to the adapter 2.
 更に、図9及び図11から理解できるように、爪220aが設けられたアーム230aを構成する2つの弾性部31間の距離は、アーム230b,230cのそれぞれを構成する2つの弾性部31間の距離より大きい。従って、アーム230aは、アーム230b,230cよりも高強度で曲げ変形しにくい。その理由は、以下の通りである。図11に示されているように、各弾性部31の主面は、内接円25の中心26を向いている。穿刺針10の長手方向に沿って見たとき、爪220が穿刺針10(または内接円25の中心26)から離れるように移動する方向と、その爪220が設けられたアーム230を構成する弾性部31の主面の法線方向とは一致しない。アーム230を構成する2つの弾性部31間の距離が大きくなるほど、爪220の移動方向と弾性部31の法線方向とがなす角度が大きくなり、弾性部31を爪220の移動方向に変形させるのにより大きな力が必要になる。従って、アーム230aは、爪230aを移動させることに関して相対的に高強度である。このアーム230aに、穿刺針10に最も近い爪220aが設けられている。これは、引張り力Fが加えられたときに、ポート90に対する爪220(特に爪220a)の係合が外れるのを防止するのに有利である。引張り力Fに対して、爪220a及びアーム230aが主として対抗するからである。一方、アーム230b,230cが相対的に低強度であることは、アダプタ2をポート90に接続する作業を容易にする。 Further, as can be understood from FIGS. 9 and 11, the distance between the two elastic portions 31 constituting the arm 230a provided with the claw 220a is the distance between the two elastic portions 31 constituting the arms 230b and 230c, respectively. Greater than the distance. Therefore, the arm 230a has higher strength than the arms 230b and 230c and is less likely to be bent and deformed. The reason is as follows. As shown in FIG. 11, the main surface of each elastic portion 31 faces the center 26 of the inscribed circle 25. When viewed along the longitudinal direction of the piercing needle 10, the claw 220 constitutes a direction in which the claw 220 moves away from the piercing needle 10 (or the center 26 of the inscribed circle 25) and an arm 230 provided with the claw 220. It does not match the normal direction of the main surface of the elastic portion 31. As the distance between the two elastic portions 31 constituting the arm 230 increases, the angle formed by the moving direction of the claw 220 and the normal direction of the elastic portion 31 increases, and the elastic portion 31 is deformed in the moving direction of the claw 220. Requires greater power. Therefore, the arm 230a is relatively strong with respect to moving the claw 230a. The arm 230a is provided with a claw 220a closest to the puncture needle 10. This is advantageous in preventing the claw 220 (particularly the claw 220a) from being disengaged from the port 90 when a tensile force F is applied. This is because the claw 220a and the arm 230a mainly oppose the tensile force F. On the other hand, the relatively low strength of the arms 230b and 230c facilitates the work of connecting the adapter 2 to the port 90.
 なお、アーム230aをアーム230b,230cより高強度にする方法は、本実施形態2に限定されず、任意である。例えば、アーム230aを構成する弾性部31の断面積を大きくする、アーム230aを構成する弾性部31に補強用のリブを設ける、等の方法により、アーム230aを相対的に高強度にしてもよい。本実施形態2とは異なり、本発明では、全てのアーム230が実質的に同じ強度を有していてもよい。 The method of making the arm 230a stronger than the arms 230b and 230c is not limited to the second embodiment and is arbitrary. For example, the arm 230a may be made relatively high in strength by increasing the cross-sectional area of the elastic portion 31 constituting the arm 230a, providing reinforcing ribs in the elastic portion 31 constituting the arm 230a, or the like. .. Unlike the second embodiment, in the present invention, all the arms 230 may have substantially the same strength.
 実施形態1と同様に、アーム230b,230cのそれぞれを構成する2つの弾性部31のうち穿刺針10に接近した弾性部(第1弾性部)を、相対的に高強度に構成してもよい。 Similar to the first embodiment, of the two elastic portions 31 constituting the arms 230b and 230c, the elastic portion (first elastic portion) close to the puncture needle 10 may be configured with relatively high strength. ..
 上記の実施形態1,2は例示に過ぎない。本発明は、上記の実施形態1,2に限定されず、適宜変更することができる。 The above embodiments 1 and 2 are merely examples. The present invention is not limited to the above-described first and second embodiments, and can be appropriately modified.
 本発明のアダプタが備える爪及びアームの数は、上記の実施形態に限定されない。爪及びアームの数は、好ましくはそれぞれ2つ以上であり、それぞれ4つ以上であってもよい。 The number of claws and arms included in the adapter of the present invention is not limited to the above embodiment. The number of claws and arms is preferably two or more, and may be four or more.
 爪の形状は、任意に変更できる。例えば、爪の先端21に、爪の内接円25に沿った円弧状の凹部が設けられている必要はない。爪の先端21に、平坦面、または、円弧状もしくはドーム状の凸部が設けられていてもよい。 The shape of the claw can be changed arbitrarily. For example, the tip 21 of the nail does not need to be provided with an arcuate recess along the inscribed circle 25 of the nail. The tip 21 of the nail may be provided with a flat surface or an arc-shaped or dome-shaped convex portion.
 爪の係止板22の形状は、任意に変更できる。また、係止板22は、先端21に向かって天板35に接近するように傾斜している必要はない。係止板22を省略し、爪が上下方向に平行なリブ23で構成されていてもよい。 The shape of the claw locking plate 22 can be changed arbitrarily. Further, the locking plate 22 does not need to be inclined so as to approach the top plate 35 toward the tip 21. The locking plate 22 may be omitted, and the claws may be composed of ribs 23 parallel to each other in the vertical direction.
 1つの爪に設けられるリブ23の数は、任意である。リブ23の形状も任意である。爪がリブ23を備えていなくてもよい。 The number of ribs 23 provided on one claw is arbitrary. The shape of the rib 23 is also arbitrary. The claws may not have ribs 23.
 1つのアームに2以上の爪が設けられていてもよい。 Two or more claws may be provided on one arm.
 複数の爪及び複数のアームが、中心26に対して等角度間隔で(即ち、内接円25に沿って周方向に等間隔で)配置されていてもよい。 A plurality of claws and a plurality of arms may be arranged at equal intervals with respect to the center 26 (that is, at equal intervals in the circumferential direction along the inscribed circle 25).
 アームの形状も、任意に変更できる。例えば、アームが、2つの弾性部31と、これらの下端をつなぐ1つ架橋部32とで構成されている必要はない。例えば、アームが、架橋部32に相当する部材を備えていなくてもよい。アームが、上下方向に沿って延びた1つの棒状(または細長い板状)の弾性部のみで構成されていてもよい。 The shape of the arm can also be changed arbitrarily. For example, the arm need not be composed of two elastic portions 31 and one bridging portion 32 connecting the lower ends thereof. For example, the arm may not include a member corresponding to the cross-linked portion 32. The arm may consist of only one rod-shaped (or elongated plate-shaped) elastic portion extending in the vertical direction.
 天板35の形状は任意である。例えば、天板35の平面視形状は、円形に限定されず、楕円形、多角形(例えば三角形、四角形)等であってもよい。天板35が切り欠き37を備えていなくてもよい。本発明のアダプタは、天板35を備えていなくてもよい。例えば、穿刺針10の基端から、アームが延びていてもよい。 The shape of the top plate 35 is arbitrary. For example, the plan view shape of the top plate 35 is not limited to a circle, but may be an ellipse, a polygon (for example, a triangle, a quadrangle), or the like. The top plate 35 does not have to have the notch 37. The adapter of the present invention does not have to include the top plate 35. For example, the arm may extend from the base end of the puncture needle 10.
 混注ポート40の水平方向の位置も任意である。例えば、混注ポート40が、穿刺針10と同軸に配置されていてもよく、あるいは、内接円25と同心に配置されていてもよい。混注ポート40と穿刺針10とが、柔軟なチューブを介して接続されていてもよい。 The horizontal position of the mixed injection port 40 is also arbitrary. For example, the mixed injection port 40 may be arranged coaxially with the puncture needle 10 or may be arranged concentrically with the inscribed circle 25. The mixed injection port 40 and the puncture needle 10 may be connected via a flexible tube.
 混注ポート40の構成は、上記の実施形態で示したニードルレスポートに限定されない。例えば、自閉式の弁機能を、セプタム45以外の構成によって実現してもよい。混注ポートが、自閉式の弁機能を備えていなくてもよい。例えば、混注ポートが、テーパ面を備えた公知のコネクタ(メスコネクタ)であってもよい。公知の任意の混注ポートを、本発明のアダプタに適用することができる。 The configuration of the mixed injection port 40 is not limited to the needleless port shown in the above embodiment. For example, the self-closing valve function may be realized by a configuration other than the septum 45. The mixed injection port does not have to have a self-closing valve function. For example, the mixed injection port may be a known connector (female connector) having a tapered surface. Any known mixed injection port can be applied to the adapter of the present invention.
 上記の実施形態では、穿刺針10内に、液体が流れる1本の流路12のみが形成されていたが、液体が流れる流路に加えて、容器内の圧力変動を防ぐために気体が流れる流路が形成されていてもよい。 In the above embodiment, only one flow path 12 through which the liquid flows is formed in the puncture needle 10, but in addition to the flow path through which the liquid flows, a flow in which a gas flows in order to prevent pressure fluctuation in the container. Roads may be formed.
 上記のアダプタの使用方法では、ポート90に本発明のアダプタを接続する前に、ゴム栓91にシリンジの金属針を穿刺して輸液バック内で薬液を調製した。しかしながら、本発明はこれに限定されない。例えば、ゴム栓91に金属針を穿刺することなく、ポート90にアダプタを接続してもよい。その後、アダプタを介して、所定の薬剤等を輸液バッグに注入し、薬液を調製してもよい。 In the above method of using the adapter, before connecting the adapter of the present invention to the port 90, the metal needle of the syringe was punctured into the rubber stopper 91 to prepare the drug solution in the infusion bag. However, the present invention is not limited to this. For example, the adapter may be connected to the port 90 without puncturing the rubber stopper 91 with a metal needle. After that, a predetermined drug or the like may be injected into the infusion bag via the adapter to prepare the drug solution.
 本発明のアダプタが接続されるポートに、金属針を穿刺すべき領域92と穿刺針を穿刺すべき領域93とが表示されていなくてもよい。 The area to which the metal needle should be punctured and the area 93 to which the puncture needle should be punctured may not be displayed on the port to which the adapter of the present invention is connected.
 本発明のアダプタが接続されるメスコネクタは、輸液バッグのポートに限定されない。例えば、本発明のアダプタを、バイアルに接続してもよい。好ましくは、メスコネクタは、穿刺針を穿刺可能な栓体(例えばゴム栓)を備える。 The female connector to which the adapter of the present invention is connected is not limited to the port of the infusion bag. For example, the adapter of the present invention may be connected to the vial. Preferably, the female connector comprises a plug capable of piercing the piercing needle (eg, a rubber plug).
 穿刺針10の流路12を流れる液体は、薬液であってもよいが、薬液以外の任意の液体であってもよい。 The liquid flowing through the flow path 12 of the puncture needle 10 may be a chemical solution, but may be any liquid other than the chemical solution.
 本発明は、制限はないが、医療分野、特に輸液において好ましく利用することができる。本発明のアダプタは、液体(特に、薬液)を貯留した容器のメスコネクタに接続するアダプタとして好ましく利用することができる。 The present invention is not limited, but can be preferably used in the medical field, especially in infusion. The adapter of the present invention can be preferably used as an adapter for connecting to a female connector of a container that stores a liquid (particularly a chemical solution).
1,2 アダプタ
10 穿刺針
20,220,220a,220b,220c 爪
25 爪の内接円
26 内接円の中心
30,230,230a,230b,230c アーム
35 天板
37 切り欠き
31,31a,31b 弾性部
40 混注ポート
90 ポート(メスコネクタ)
1, 2, Adapter 10 Puncture needle 20, 220, 220a, 220b, 220c Claw 25 Claw inscribed circle 26 Center of inscribed circle 30, 230, 230a, 230b, 230c Arm 35 Top plate 37 Notch 31, 31a, 31b Elastic part 40 Mixed injection port 90 port (female connector)

Claims (8)

  1.  メスコネクタに穿刺可能な穿刺針と、
     前記穿刺針をメスコネクタに穿刺したとき前記メスコネクタに係合するように前記穿刺針に向かって突出した複数の爪と、
     前記複数の爪が設けられ、前記複数の爪が前記穿刺針から離れるように弾性変形可能な複数のアームと、
     前記穿刺針に連通した混注ポートとを備えたアダプタであって、
     前記穿刺針の長手方向に沿って見たとき、前記複数の爪に内接する円に対して前記穿刺針が偏心していることを特徴とするアダプタ。
    A puncture needle that can puncture the female connector,
    A plurality of claws protruding toward the puncture needle so as to engage with the female connector when the puncture needle is punctured into the female connector.
    A plurality of arms provided with the plurality of claws and elastically deformable so that the plurality of claws are separated from the puncture needle.
    An adapter provided with a mixed injection port communicating with the puncture needle.
    An adapter characterized in that the puncture needle is eccentric with respect to a circle inscribed in the plurality of nails when viewed along the longitudinal direction of the puncture needle.
  2.  前記複数の爪は、前記円に沿って不均一に配置されている請求項1に記載のアダプタ。 The adapter according to claim 1, wherein the plurality of claws are unevenly arranged along the circle.
  3.  前記穿刺針に対して前記円の中心が位置する側には、前記複数の爪及び前記複数のアームは配置されていない請求項1又は2に記載のアダプタ。 The adapter according to claim 1 or 2, wherein the plurality of claws and the plurality of arms are not arranged on the side where the center of the circle is located with respect to the puncture needle.
  4.  前記穿刺針と前記混注ポートとの間の位置に外向きに突出した天板を更に備え、
     前記天板に前記複数のアームが設けられており、
     前記穿刺針の長手方向に沿って見たとき、前記天板の、前記穿刺針に対して前記円の中心が位置する側の部分が切り欠かれている請求項1~3のいずれか一項に記載のアダプタ。
    A top plate protruding outward is further provided at a position between the puncture needle and the mixed injection port.
    The plurality of arms are provided on the top plate.
    Any one of claims 1 to 3 in which a portion of the top plate on the side where the center of the circle is located is cut out when viewed along the longitudinal direction of the puncture needle. The adapter described in.
  5.  前記混注ポートは、前記円に対して、前記穿刺針が前記円に対して偏心するのと同じ側に偏心している請求項1~4のいずれか一項に記載のアダプタ。 The adapter according to any one of claims 1 to 4, wherein the mixed injection port is eccentric to the circle on the same side as the puncture needle is eccentric to the circle.
  6.  前記混注ポートは、前記円に対して、前記穿刺針よりも更に大きく偏心している請求項5に記載のアダプタ。 The adapter according to claim 5, wherein the mixed injection port is eccentric to the circle even more than the puncture needle.
  7.  前記複数のアームのそれぞれは、前記穿刺針と略平行に延びた第1弾性部及び第2弾性部を備え、
     前記第1弾性部及び前記第2弾性部の先端側に前記爪が設けられており、
     前記第1弾性部及び前記第2弾性部は、前記円と同心の円に沿って配置されており、
     前記第1弾性部は、前記第2弾性部よりも、前記穿刺針に接近して配置されており、
     前記第1弾性部は、前記第2弾性部に比べて高強度である請求項1~6のいずれか一項に記載のアダプタ。
    Each of the plurality of arms includes a first elastic portion and a second elastic portion extending substantially parallel to the puncture needle.
    The claw is provided on the tip side of the first elastic portion and the second elastic portion.
    The first elastic portion and the second elastic portion are arranged along a circle concentric with the circle.
    The first elastic portion is arranged closer to the puncture needle than the second elastic portion.
    The adapter according to any one of claims 1 to 6, wherein the first elastic portion has higher strength than the second elastic portion.
  8.  前記複数の爪のうち前記穿刺針から最も近い爪が設けられたアームは、他のアームに比べて高強度である請求項1~7のいずれか一項に記載のアダプタ。 The adapter according to any one of claims 1 to 7, wherein the arm provided with the claw closest to the puncture needle among the plurality of claws has higher strength than the other arms.
PCT/JP2020/012999 2019-03-27 2020-03-24 Adapter WO2020196511A1 (en)

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Citations (4)

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JPS485709B1 (en) * 1970-05-27 1973-02-19
JP2014079355A (en) * 2012-10-16 2014-05-08 Jms Co Ltd Puncture needle adapter
JP2014534026A (en) * 2011-10-31 2014-12-18 ジーイー・ヘルスケア・リミテッド Puncture filling device
JP2015526235A (en) * 2012-08-26 2015-09-10 メディモップ・メディカル・プロジェクツ・リミテッド Liquid transfer device

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4552271B2 (en) * 2000-05-15 2010-09-29 ニプロ株式会社 Liquid transfer tool
KR101986869B1 (en) * 2012-02-02 2019-06-07 벡톤 디킨슨 홀딩즈 피티이 엘티디. Adaptor for coupling with a medical container

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS485709B1 (en) * 1970-05-27 1973-02-19
JP2014534026A (en) * 2011-10-31 2014-12-18 ジーイー・ヘルスケア・リミテッド Puncture filling device
JP2015526235A (en) * 2012-08-26 2015-09-10 メディモップ・メディカル・プロジェクツ・リミテッド Liquid transfer device
JP2014079355A (en) * 2012-10-16 2014-05-08 Jms Co Ltd Puncture needle adapter

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