WO2013099610A1 - Unité adaptatrice - Google Patents

Unité adaptatrice Download PDF

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Publication number
WO2013099610A1
WO2013099610A1 PCT/JP2012/082214 JP2012082214W WO2013099610A1 WO 2013099610 A1 WO2013099610 A1 WO 2013099610A1 JP 2012082214 W JP2012082214 W JP 2012082214W WO 2013099610 A1 WO2013099610 A1 WO 2013099610A1
Authority
WO
WIPO (PCT)
Prior art keywords
cap
adapter
base end
guide
screwing
Prior art date
Application number
PCT/JP2012/082214
Other languages
English (en)
Japanese (ja)
Inventor
将郎 川村
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2013099610A1 publication Critical patent/WO2013099610A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2065—Connecting means having aligning and guiding means

Definitions

  • the present invention relates to an adapter unit.
  • a vial container drug storage container
  • a container body having a mouth portion at the tip thereof, and a soft sealing member for sealing the mouth portion.
  • an adapter unit device including an adapter to which a syringe can be connected is attached to the mouth of the vial container (see, for example, Patent Document 1). Via this adapter, the vial container and the syringe are connected.
  • the adapter unit described in Patent Document 1 is a base end side structure (support) having a mounting portion to be mounted on the mouth of the vial container, and is detachably mounted (connected) to the base end side structure.
  • the cap and the adapter are assembled by screwing together, and by rotating the cap around its axis, the adapter moves toward the vial container and pierces the sealing member with a hollow needle Can do.
  • the base end side structure and the cap are connected by engagement (snap fitting) between a convex portion (bead) provided in the base end side structure and a concave portion (groove) provided in the cap. Yes.
  • An object of the present invention is to provide an adapter unit that can be easily and reliably attached to a medical container and that can be reliably used after the cap is removed in the attached state.
  • An adapter unit that is used in a mounted state mounted on a medical container that has a cylindrical shape and has a container body having a mouth portion at a tip portion thereof and a soft sealing member that seals the mouth portion.
  • a first cap-side threaded portion having a first threaded portion spirally formed around the central axis on the inner peripheral side of the cylindrical body, and the first of the cylindrical body.
  • a cap having a second cap-side threaded portion having a second threaded portion spirally formed around the central axis at a position different from the cap-side threaded portion of 1;
  • a main body portion having a disk-like disk portion, which is disposed on the inner side of the cap so as to be movable in the proximal direction, and provided on an outer peripheral portion of the disk portion, the first cap side
  • An adapter having an adapter-side threaded portion that is threadedly engaged with the threaded portion; and a hollow needle that can pierce the sealing member;
  • a first operation as an assembled adapter assembly Performing the second operation of assembling the adapter assembly and the base end side structure by screwing the second cap side screwing portion and the base end side screwing portion; During the second operation, the adapter and the base-end-side structure approach each other. At that time, the guide portion is pressed while the tip portion presses the elastic piece toward the tip. Sliding toward the guide hole with respect to the elastic piece elastically deformed, inserted into the guide hole, By rotating the cap around the central axis in the mounted state, the screwing between the second cap side screwing portion and the base end side screwing portion is released, and the cap is moved to the base end.
  • the adapter When the adapter is detached from the side structure, the adapter moves toward the base end while preventing rotation due to the insertion of the guide portion into the guide hole, and thereby the adapter side screw is removed.
  • the adapter is characterized in that a joint part is detached from the first cap side screwing part, the hollow needle pierces the sealing member, and the inside of the container body communicates with the outside through the hollow needle. unit.
  • the base-end structure is mounted on the medical container in advance, or is mounted on the medical container after being assembled with the adapter assembly in the second operation (1) Adapter unit as described in.
  • the number of turns of the screw at the first cap-side screwing portion is the same as or less than the number of turns of the screw at the second cap-side screwing portion (1) or (2 Adapter unit as described in).
  • the second cap-side screwing portion is formed on the inner peripheral side of the cylindrical body on the base end side with respect to the first cap-side screwing portion.
  • the base-end-side structure includes the guide portion, the guide structure that can be mounted in the storage portion, and the restriction portion that restricts rotation of the guide structure with respect to the storage portion.
  • the guide structure has a ring-shaped main body part, a guide part protrudingly formed at a distal end of the main body part, and a leg part protrudingly formed at a base end of the main body part,
  • the storage portion has a rib formed to protrude from the inner peripheral portion,
  • limiting part is an adapter unit as described in said (10) comprised by the rib of the said leg part and the said accommodating part.
  • a detachment prevention portion that prevents the guide structure from being detached from the storage member is formed on the base end side of the base end side screwing portion.
  • the adapter communicates with the hollow needle and has a connection portion to which a syringe is connected in a state where the cap is detached.
  • the adapter unit according to any one of (1) to (12), wherein when the syringe is connected to the connection portion, the syringe and the container main body communicate with each other via the connection portion and the hollow needle.
  • the adapter unit can be easily and reliably attached to the medical container by a simple operation of screwing the cap and the base end side structure. Further, this mounting state is reliably maintained by screwing the cap and the base end side structure, and the cap is unintentionally detached even if a tensile force in the distal direction acts on the cap, for example. Is prevented.
  • the adapter is configured to be attached to the medical container in conjunction with the operation of removing the cap.
  • the adapter has an adapter and a cap that are screwed together, and a base end side structure, and is engaged (snapped) between a protrusion provided on the base end structure and a recess provided on the cap.
  • the cap and the base end side structure are connected by fitting
  • a tensile force is applied to the cap unintentionally during the rotation of the cap (for example, an operator)
  • the adapter will detach from the proximal structure with the cap before it is fully attached to the medical container.
  • a syringe cannot be connected to the medical container, and the medical container cannot be used.
  • the medical container can be used quickly and reliably after the cap is removed, and the operability is excellent.
  • FIG. 1 is a longitudinal cross-sectional view sequentially illustrating the operation process of the adapter unit (first embodiment) of the present invention.
  • FIG. 2 is a longitudinal cross-sectional view sequentially illustrating the operation process of the adapter unit (first embodiment) of the present invention.
  • FIG. 3 is a longitudinal cross-sectional view sequentially illustrating the operation process of the adapter unit (first embodiment) of the present invention.
  • FIG. 4 is a longitudinal cross-sectional view sequentially showing the operation process of the adapter unit (first embodiment) of the present invention.
  • FIG. 5 is a longitudinal cross-sectional view sequentially illustrating the operation process of the adapter unit (first embodiment) of the present invention.
  • FIG. 6 is a longitudinal cross-sectional view sequentially illustrating the operation process of the adapter unit (first embodiment) of the present invention.
  • FIG. 7 is a cross-sectional view showing the change over time in the positional relationship between the elastic piece of the adapter and the guide portion of the proximal end structure in the operation process of the adapter unit of the present invention ((a) is the direction of arrow B in FIG. (B) is a view seen from the direction of arrow C in FIG. 3, and (c) is a view seen from the direction of arrow D in FIG. 4).
  • FIG. 8 is a perspective view of an adapter provided in the adapter unit of the present invention.
  • FIG. 9 is a plan view of an adapter provided in the adapter unit of the present invention.
  • FIG. 10 is a cross-sectional view taken along line AA in FIG.
  • FIG. 11 is a longitudinal sectional view sequentially illustrating the operation process of the adapter unit (second embodiment) of the present invention.
  • FIG. 12 is a longitudinal cross-sectional view sequentially illustrating the operation process of the adapter unit (second embodiment) of the present invention.
  • 13 is a cross-sectional view taken along line EE in FIG.
  • FIGS. 1 to 6 are longitudinal sectional views sequentially showing the operation process of the adapter unit (first embodiment) of the present invention
  • FIG. 7 is an elastic piece and a base end of the adapter in the operation process of the adapter unit of the present invention.
  • Sectional drawing which shows a time-dependent change of the positional relationship with the guide part of a side structure ((a) is the figure seen from the arrow B direction in FIG. 2, (b) is the figure seen from the arrow C direction in FIG.
  • FIG. 8 is a perspective view of the adapter included in the adapter unit of the present invention
  • FIG. 9 is a plan view of the adapter included in the adapter unit of the present invention.
  • 10 is a cross-sectional view taken along line AA in FIG.
  • the lower side in FIGS. 1 to 8 (the same applies to FIGS. 11 and 12) is “base” or “down (downward)”, and the upper side is “tip” or “upper”. (Up) ”.
  • the medical device set 100 includes a medical container 1 and an adapter unit 10 used in a mounted state attached to the medical container 1.
  • the medical device set 100 includes a syringe 20 in addition to the medical container 1 and the adapter unit 10 (see FIG. 6).
  • a syringe 20 in addition to the medical container 1 and the adapter unit 10 (see FIG. 6).
  • the medical container 1 includes a container body 2 and a plug (sealing member) 3.
  • the medical container 1 stores a medicine P in powder form, liquid form or the like (in this embodiment, powder form) in advance.
  • the medicine P is mixed with a liquid Q such as a dissolving liquid, a diluting liquid, or a chemical liquid supplied from the syringe 20. This mixture is the chemical solution R.
  • medicine P it is necessary to dissolve when using a medicine, an antibiotic, a hemostatic agent, or the like that is dangerous if a medical worker accidentally touches it, such as an anticancer agent or an immunosuppressant.
  • Drugs drugs that need to be diluted, such as drugs for children, vaccines, heparin, drugs that are used multiple times, such as drugs for children, drugs that easily foam when dissolved in protein preparations or when sucked into syringes, antibody drugs, etc. Examples include drugs with small amounts of stored medicine.
  • the liquid Q is not particularly limited, and examples thereof include physiological saline.
  • the container body 2 is composed of a bottomed cylindrical member.
  • the distal end portion of the container body 2 has an inner diameter and an outer diameter that are reduced in diameter, and constitutes a mouth portion 21 through which liquid passes.
  • the proximal end structure 6 included in the adapter unit 10 is attached to the mouth portion 21.
  • a ring-shaped protrusion 211 is formed on the outer peripheral portion of the mouth portion 21 along the circumferential direction.
  • the constituent material of the container body 2 is not particularly limited, and other than glass, for example, polyolefins such as polyethylene and polypropylene, cyclic polyolefins such as cycloolefin polymers and cyclic olefin copolymers, polyesters such as polyethylene terephthalate, vinyl chloride resins, Examples thereof include vinyl resins such as polyvinyl alcohol, polyamides such as nylon 6, nylon 6,6, nylon 6,10, nylon 6,12, etc., and other resin materials such as thermoplastic resins. Species or a combination of two or more can be used. In addition, in order to cut a specific wavelength, a material obtained by adding a light shielding additive to a constituent material may be used.
  • polyolefins such as polyethylene and polypropylene
  • cyclic polyolefins such as cycloolefin polymers and cyclic olefin copolymers
  • polyesters such as polyethylene terephthalate
  • the inner surface of the container body 2 may be coated with Teflon (“Teflon” is a registered trademark) or a fluorine coating. Each of these members may have transparency in order to ensure internal visibility.
  • a soft plug 3 made of an elastic material is attached to the mouth 21 of the container body 2. Thereby, the mouth part 21 can be liquid-tightly sealed.
  • the plug 3 has a top plate 31 formed of a circular plate and a cylindrical portion 33 protruding from the base end surface 311 of the top plate 31.
  • the top plate 31 is a portion through which a bottle needle (hollow needle) 50 of an adapter (inner structure) 30 as a connection tool provided in the adapter unit 10 is pierced. And the syringe 20 is connected to the adapter 30 which penetrated the top plate 31 (refer FIG. 6). By operating the syringe 20 in this connected state, the liquid Q from the syringe 20 flows in through the mouth portion 21 or the chemical solution R flows out toward the syringe 20.
  • the top plate 31 is particularly sterilized at the distal end surface 312.
  • the sterilized state that is, the aseptic state, is maintained by the seal member 16 described later.
  • the outer diameter of the cylindrical portion 33 is set slightly larger than the inner diameter of the mouth portion 21 of the container body 2. Thereby, when the tubular portion 33 is inserted into the mouth portion 21, the tubular portion 33 is in close contact with the inner peripheral surface of the mouth portion 21. Thereby, the mouth part 21 is sealed in a liquid-tight manner.
  • Examples of the elastic material constituting the plug body 3 include various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, urethane rubber and fluororubber, and various thermoplastic elastomers such as styrene and polyolefin. 1 type or 2 types or more of these can be mixed and used.
  • the syringe 20 is a syringe filled with a liquid Q mixed with the medicine P in advance.
  • the syringe 20 has an outer cylinder 201.
  • the outer cylinder 201 has a bottomed cylindrical shape, and a mouth part 202 that protrudes in a tubular shape in the distal direction is formed at the bottom.
  • the syringe 20 includes a gasket (not shown) that can slide in a liquid-tight manner in the outer cylinder 201, and a plunger (not shown) that is connected to the gasket and moves the gasket in the outer cylinder 201. have. Then, by pressing the plunger, the liquid Q can be discharged from the mouth portion 202 with the gasket.
  • a ring-shaped lock member (lock adapter) 203 is disposed concentrically with the mouth portion 202 on the outer peripheral side of the mouth portion 202.
  • a female screw 204 that is screwed into the adapter 30 is formed on the inner peripheral portion of the lock member 203.
  • the syringe 20 and the adapter 30 are connected by this screwing.
  • the lock member 203 is integrally formed with the mouth portion 202, but is not limited thereto, and may be configured separately from the mouth portion 202.
  • the lock member 203 may be supported so as to be movable along the axial direction of the mouth portion 202, and around the axis of the mouth portion 202. You may be supported so that rotation is possible.
  • Such a syringe 20 is connected to the medical container 1 via the adapter 30.
  • the adapter unit 10 As shown in FIGS. 1 to 6, the adapter unit 10 is attached to a cap (tip-side structure) 7 formed of a cylindrical body, an adapter 30 disposed inside the cap 7, and the medical container 2. And a proximal-side structure 6.
  • a cap tip-side structure
  • the adapter unit 10 is attached to a cap (tip-side structure) 7 formed of a cylindrical body, an adapter 30 disposed inside the cap 7, and the medical container 2.
  • a proximal-side structure 6 it does not specifically limit as a constituent material of the cap 7, the adapter 30, and the base end side structure 6,
  • the material similar to the container main body 2 of the medical container 1 can be used.
  • the cap 7 is a member that is detachably attached to the base end side structure 6 and is rotated around the central axis O when the base end side structure 6 is detached from the base end side structure 6 so that the disengagement operation is performed.
  • the cap 7 includes a top plate 75 and a wall 76 that is formed in a cylindrical shape along the edge of the top plate 75 and protrudes from the edge toward the proximal direction.
  • a cap-side female screw portion (first cap-side screwed portion) 73 is formed in the wall portion 76 (cylindrical body) of the cap 7 in the middle of the inner peripheral portion (inner peripheral side) in the central axis O direction. Yes. Further, on the inner peripheral portion of the wall portion 76 of the cap 7, the cap-side female screw portion (second second end) is located at a position different from the cap-side female screw portion 73, that is, at the base end side of the cap-side female screw portion 73. Cap side screwing part) 74 is formed.
  • the cap-side female screw portion 73 is a portion having a first screw thread (first screw portion) 731 formed in a spiral shape around the central axis O.
  • the cap-side female screw portion 74 is a portion having a second screw thread (second screw portion) 741 formed in a spiral shape around the central axis O.
  • the pitch s 1 between the first screw threads 731 adjacent to each other along the direction of the central axis O in the cap-side female screw portion 73 is equal to the central axis in the cap-side female screw portion 74. It is larger than the pitch s 2 between the second screw threads 741 adjacent to each other along the O direction. Further, the formation length u 1 along the direction of the central axis O of the cap side female screw portion 73 is longer than the formation length u 2 along the direction of the central axis O of the cap side female screw portion 74.
  • the number of turns of the first screw thread 731 in the cap-side female screw part 73 is the same as or less than the number of turns of the second screw thread 741 in the cap-side male screw part 74.
  • a portion on the tip side of the inner peripheral portion of the cap 7 with respect to the cap-side female screw portion 73 is a reduced diameter portion 77 whose inner diameter is reduced.
  • the adapter 30 is disposed inside the cap 7 so as to be movable in the proximal direction. As shown in FIGS. 1 to 6 and 8, the adapter 30 is connected to the main body 40, a bottle needle (hollow needle) 50 that can pierce the stopper 3 of the medical container 1, and the syringe 20. Part 90.
  • the main body 40 is composed of a disk-shaped disk part 403 and an adapter-side male screw part (adapter-side threaded part) 408 provided on the outer periphery of the disk part 403.
  • the disc portion 403 is formed with a plurality of (three in the illustrated configuration) guide holes 409 penetrating in the thickness direction.
  • the guide holes 409 are arranged at equiangular intervals around the central axis O, respectively.
  • Each guide part 67 which the base end side structure 6 has is inserted in each such guide hole 409. FIG.
  • each guide portion 67 can guide the adapter 30 (see FIG. 5).
  • two slits 406 communicate with each guide hole 409.
  • the two slits 406 pass through the disk portion 403 in the thickness direction, and are formed side by side so as to extend from the guide hole 409 in the clockwise direction in FIG. 9, that is, around the central axis O. Yes.
  • a portion surrounded by the two slits 406 and the guide hole 409 formed in this way becomes an elastic piece 407 having an arc shape along the circumferential direction of the disc portion 403.
  • the elastic piece 407 can be elastically changed by the pressing by the guide portion 67 of the base end side structure 6 and the release of the pressing.
  • the elastic piece 407 is configured by a portion surrounded by the two slits 406 and the guide hole 409, but is not limited to this, and the single slit 406 and the guide hole 409 is configured. It may be composed of a portion surrounded by. In this case, the guide hole 409 is open toward the outer peripheral side of the disc portion 403.
  • a plurality of (three in the configuration shown in FIG. 9) engagement holes 405 are formed in the disk portion 403 at a portion inside the three guide holes 409.
  • Each engagement hole 405 has a proximal-side structure when the adapter 30 moves toward the proximal end, and at the movement limit, that is, when the bottle needle 50 penetrates the stopper 3 of the medical container 2. This is the part with which the body 6 is engaged. By this engagement, it is possible to reliably prevent the bottle needle 50 of the adapter 30 from being removed from the plug body 3.
  • the adapter-side male screw portion 408 is a portion that is screwed with the cap-side female screw portion 73 of the cap 7.
  • the adapter-side male screw portion 408 includes a protrusion 401 formed in a ring shape along the circumferential direction of the outer peripheral portion (edge portion) of the disc portion 403, and the protrusion 401 This is a portion where a plurality of (three in the configuration shown in FIG. 9) grooves 402 are formed in the middle of the forming direction.
  • Each groove 402 is formed to be inclined with respect to the central axis O.
  • the first thread 731 of the cap-side female thread portion 73 of the cap 7 can be engaged, that is, inserted.
  • the adapter-side male screw portion 408 and the cap-side female screw portion 73 are screwed together.
  • the bottle needle 50 is disposed on the central axis O on the base end surface of the disc portion 403.
  • the bottle needle 50 has a sharp needle tip 501 that can pierce the top plate 31 of the stopper 3 of the medical container 1.
  • the bottle needle 50 is a hollow needle and has at least one (two in this embodiment) side hole 502 opened on a side surface thereof (see FIG. 4).
  • connection part 90 is a part to which the syringe 20 is connected in a state where the cap 7 is detached (see FIG. 6).
  • the connecting portion 90 has a cylindrical shape and is disposed on the central axis O at the distal end surface of the disc portion 403. This connecting portion 90 communicates with the bottle needle 50.
  • the inner peripheral part 901 of the connecting part 90 has a tapered shape whose inner diameter gradually decreases in the proximal direction. And when the syringe 20 is connected to the connection part 90, the outer peripheral part 205 of the opening part 202 of the syringe 20 and the inner peripheral part 901 of the connection part 90 fit. In this state, the syringe 20 and the medical container 1 (container body 2) communicate with each other via the connection unit 90 and the bottle needle 50, and the liquid can flow back and forth between them.
  • a male screw 902 is formed on the outer periphery of the connecting portion 90.
  • the female screw 204 of the lock member 203 of the syringe 20 can be screwed into the male screw 902. By this screwing, the state where the syringe 20 is connected to the connecting portion 90 can be maintained.
  • the base end side structure 6 includes a cylindrical base portion 61, a disc portion (base end side disc portion) 62 disposed on the front end side of the base portion 61, and A connecting portion 64 that connects the base portion 61 and the disc portion 62 is provided.
  • the base 61 is arranged concentrically with the container main body 2 on the outer peripheral side of the container main body 2 in a mounted state mounted on the medical container 1.
  • the adapter unit 10 When the adapter unit 10 is operated, that is, when the cap 7 is rotated around the central axis O, the cap 7 is gripped by one hand and the base 61 is gripped by the other hand to perform the operation. be able to.
  • the base 61 functions as a gripping part that is gripped when the adapter unit 10 is operated.
  • a base end side male screw portion (base end side screwing portion) 69 is provided on the outer peripheral end portion of the base portion 61.
  • the proximal-side male screw portion 69 has a groove 691 formed in a spiral shape around the central axis O. Then, the second screw thread 741 of the cap-side female screw portion 74 of the cap 7 can be inserted into the groove 691, that is, inserted. Thereby, the base end side male screw portion 69 and the cap side female screw portion 74 are screwed together.
  • the formation length along the central axis O direction of the base end side male screw portion 69 is the same as the formation length u 2 of the cap side female screw portion 74.
  • a plurality of (for example, three) ribs 611 extending along the central axis O direction are formed to protrude from the inner peripheral portion of the base portion 61.
  • Each rib 611 can be in contact with the outer peripheral portion of the container body 2 of the medical container 1 to prevent rattling, that is, radial displacement of the medical container 1 with respect to the proximal end structure 6.
  • the disc part 62 has a disc shape, and its surface is orthogonal to the central axis O and is concentrically arranged with the base part 61.
  • the diameter of the disc part 62 is smaller than the diameter of the base part 61.
  • a plurality of sharp (for example, four) protrusions 621 are formed on the base end face of the disc portion 62 so as to protrude. Each protrusion 621 is punctured on the distal end surface 312 of the plug 3 of the medical container 1. Thereby, positioning of base end side structure 6 (guide part 67) and medical container 1 is made.
  • the connecting portion 64 includes a plurality of columnar portions 641 (three in the illustrated configuration) that are arranged at equiangular intervals around the central axis O.
  • the proximal-side structure 6 includes a mounting portion 66 to be attached to the medical container 1, and a plurality of (three in the present embodiment) guide portions 67 that guide the adapter 30 moving toward the proximal direction. And an engaging portion 68 that engages with the adapter 30 at the movement limit.
  • the mounting portion 66 is composed of three projecting pieces 661 projecting from the base end surface of the disc portion 62 toward the base end direction.
  • the protrusions 661 are arranged at equiangular intervals around the central axis O, respectively. Further, the protruding pieces 661 and the columnar portions 641 constituting the connecting portion 64 are alternately arranged around the central axis O.
  • each protrusion 661 is formed with a claw 662 protruding inward at the lower end thereof. And this nail
  • Each guide part 67 is a part that forms a columnar shape (long shape) that protrudes from the distal end surface of the disc part 62 toward the distal end direction.
  • the guide portions 67 are arranged at equiangular intervals around the central axis O, and are positioned on the extended lines of the columnar portions constituting the connecting portion 64.
  • each guide portion 67 is inserted into the guide hole 409 of the adapter 30, respectively.
  • each guide portion 67 is inserted into the guide hole 409 of the adapter 30
  • the distal end 671 (the distal end portion) of each elastic piece 407 of the adapter 30 extends from the proximal end side. Press. Details of this will be described later.
  • the engaging portion 68 includes three protruding pieces 681 that protrude from the distal end surface of the disc portion 62 toward the distal end direction.
  • the protrusions 681 are arranged at equiangular intervals around the central axis O, respectively. Further, the protruding pieces 681 and the guide portions 67 are alternately arranged around the central axis O.
  • Each protrusion 681 is formed with a claw 682 protruding outward at the upper end thereof. As shown in FIGS. 5 and 6, the claw 682 can be engaged with the edge of the engagement hole 405 formed in the main body 40 of the adapter 30. Thereby, the base end side structure 6 and the adapter 30 are connected, and the adapter 30 is prevented from being unintentionally detached from the base end side structure 6.
  • a seal member 16 is interposed between the inner peripheral portion of the base portion 61 of the proximal end structure 6 and the outer peripheral portion of the container body 2 of the medical container 1. .
  • the seal member 16 has a ring shape along the inner peripheral portion of the base portion 61 and is fixed to the inner peripheral portion of the base portion 61.
  • the fixing method is not particularly limited, and for example, a method using adhesion (adhesion with an adhesive or a solvent), a method using fusion (thermal fusion, high frequency fusion, ultrasonic fusion, etc.), or the like can be used. .
  • Such a sealing member 16 maintains the sterilized state of the top plate 31 of the plug 3. This state is reliably maintained until the medical device set 100 is used. Therefore, in the medical device set 100, the seal member 16 functions as a means for maintaining the sterilized state of the top plate 31 of the plug 3 while the adapter unit 10 is mounted on the medical container 1.
  • the sealing member 16 does not specifically limit as a constituent material of the sealing member 16,
  • the material similar to the plug 3 of the medical container 1 can be used.
  • proximal end structure 6 is mounted on the medical container 1 and assembled in advance before performing the first operation and the second operation. This assembly is performed as follows.
  • an adapter assembly (first assembly) 101 in which a cap 7 and an adapter 30 are assembled is used. This assembly is performed as follows.
  • the adapter 30 is inserted into the cap 7 from its proximal end side, and the cap-side female screw portion 73 of the cap 7 and the adapter-side male screw portion 408 of the adapter 30 are screwed together.
  • the adapter-side male screw portion 408 is screwed with the cap-side female screw portion 74 positioned on the base end side with respect to the cap-side female screw portion 73 before being screwed with the cap-side female screw portion 73.
  • the inner diameter of the cap-side female screw portion 74 is larger than that of the cap-side female screw portion 73, the cap-side female screw portion 74 is not screwed and passes through the cap-side female screw portion 74. Can do.
  • the adapter assembly 101 in which the adapter 30 is housed in the cap 7 and assembled is obtained.
  • the medical container assembly 102 is inserted into the cap 7 of the adapter assembly 101 from the proximal end side thereof, and the adapter assembly 101 is rotated around the central axis O in a predetermined direction with respect to the medical container assembly 102.
  • the cap-side female screw portion 74 of the cap 7 and the base-end side male screw portion 69 of the base-end side structure 6 are screwed together.
  • the adapter 30 and the proximal end structure 6 gradually approach each other, and the distal ends 671 of the respective guide portions 67 of the proximal end structure 6 are moved.
  • Abuts against the base end surface of each elastic piece 407 of the adapter 30 see FIGS. 2 and 7A).
  • each guide portion 67 slides toward the guide hole 409 with respect to the elastic piece 407 that is elastically deformed by being pressed while the tip 671 presses the elastic piece 407 toward the tip. It moves (see FIGS. 3 and 7B). Since each elastic piece 407 is an arc-shaped portion as described above, each guide portion 67 is elastic when the screwing is advanced (the adapter assembly 101 is rotated). The piece 407 can be reliably pressed along the arc shape.
  • each guide portion 67 gets over the elastic piece 407 and is inserted into the guide hole 409 (see FIGS. 4 and 7C). At this time, each elastic piece 407 is released from being pressed by the guide portion 67 and restored to its original shape.
  • the adapter assembly 101 in which the adapter 30 is housed in the cap 7 and assembled is obtained.
  • the assembled medical container 1 with the adapter unit 10 attached is obtained by such assembly.
  • the adapter unit 10 can be easily and securely attached to the medical container 1 by a simple operation of screwing the cap 7 of the adapter assembly 101 and the proximal end structure 6 of the medical container assembly 102 together. can do. Further, this mounting state is reliably maintained by screwing between the cap 7 and the base end side structure 6, and the cap 7 is unintentional even if a tensile force in the distal direction acts on the cap 7. It is prevented from leaving.
  • the proximal-side structure 6 is mounted on the medical container 1 in advance, but is not limited thereto.
  • the base-end structure 6 is assembled with the adapter assembly 101 by the second operation without using the medical container assembly 102. After that, it may be attached to the medical container 1.
  • the cap 7 is gradually released from being screwed with the base-end-side male screw portion 69 of the base-end-side structure 6 of the cap-side female screw portion 74, Move toward the tip.
  • the pitch s 1 of the cap-side female screw portion 73 is set larger than the pitch s 2 of the cap-side female screw portion 74. Accordingly, when the cap 7 rotates, the adapter 30 screwed into the cap-side female screw portion 73 is prevented from rotating at each guide portion 67 and corresponds to the rotation amount of the cap 7 along the guide portion 67. It moves toward the base end by the distance (corresponding).
  • the total moving distance of the adapter 30 is “((length of one pitch of the cap-side female screw portion 73) ⁇ (length of one pitch of the cap-side male screw portion 74)) ⁇ (cap-side female screw portion 73. No. of turns) ”.
  • the cap 7 is detached from the base end side structure 6 when the screwing with the base end side structure 6 is completely released.
  • the number of turns of the first screw thread 731 at the cap-side female screw part 73 is equal to or less than the number of turns of the second screw thread 741 at the cap-side male screw part 74.
  • 30 is moving the total moving distance, so that the adapter-side male screw portion 408 is detached from the cap-side female screw portion 73, and the bottle needle 50 penetrates the stopper 3 of the medical container 1, and the bottle needle The inside of the medical container 1 communicates with the outside through 50.
  • the engaging portion 68 of the base end structure 6 is engaged with the edge portion of each engaging hole 405 of the adapter 30. Thereby, the removal of the base end side structure 6 of the adapter 30 is prevented, and thus the piercing state of the bottle needle 50 to the stopper 3 is maintained.
  • the syringe 20 is connected to the adapter 30 in communication with the medical container 1 (hereinafter, this state is referred to as “connected state”). Thereby, the medical container 1 and the syringe 20 communicate with each other via the adapter 30.
  • connection operation is performed by screwing the male screw 902 of the connecting portion 90 of the adapter 30 and the female screw 204 of the lock member 203 of the syringe 20.
  • the plunger of the syringe 20 is pressed in the connected state to supply the liquid Q from the syringe 20 into the medical container 1.
  • the liquid Q flows down the connecting portion 90 and the bottle needle 50 in this order, and flows into the medical container 1 through the side hole 502 of the bottle needle 50.
  • medical agent P mix, and the chemical
  • the drug P is completely dissolved in the liquid Q, and the drug solution R is reliably generated.
  • the adapter unit 10 configured as described above is configured such that the adapter 90 is securely attached to the medical container 1 in conjunction with the operation of removing the cap 7, that is, removing the cap.
  • the medical container 1 can be used reliably after the cap 7 is detached.
  • the adapter has an adapter and a cap that are screwed together, and a base end side structure, and is engaged (snapped) between a protrusion provided on the base end structure and a recess provided on the cap.
  • the cap and the base end side structure are connected by fitting
  • a tensile force is applied to the cap unintentionally during the rotation of the cap (for example, an operator)
  • the adapter will detach from the proximal structure with the cap before it is fully attached to the medical container.
  • a syringe cannot be connected to the medical container, and the medical container cannot be used.
  • the adapter unit 10 can use the medical container 1 quickly and reliably after the cap 7 is removed, and is excellent in operability.
  • FIGS. 11 and 12 are longitudinal sectional views sequentially showing the operation process of the adapter unit (second embodiment) of the present invention
  • FIG. 13 is a sectional view taken along line EE in FIG.
  • the cap 7A has a cap-side male screw portion (second cap-side screw) that is screwed to the base end-side structure 6A at its outer peripheral portion (outer peripheral side). 79) is formed.
  • the cap side male screw portion 79 is a portion having a second screw thread 791 formed in a spiral shape around the central axis O.
  • the pitch s 1 at the cap-side female screw portion 73 is the pitch s between the second screw threads 791 adjacent to each other along the central axis O direction at the cap-side male screw portion 79. Greater than 2 . Further, the formation length u 1 of the cap side female screw portion 73 is longer than the formation length u 2 along the direction of the central axis O of the cap side male screw portion 79.
  • the adapter 30A has the engagement hole 405 omitted from the disc portion 403, and the disc portion 403 is provided with an engagement portion 404 that engages the medical container 1.
  • the engaging portion 404 includes three projecting pieces 404 a that project from the base end surface of the disc portion 403 toward the base end direction.
  • the protrusions 404a are arranged at equiangular intervals around the central axis O, respectively.
  • each protrusion 404a is formed with a claw 404b protruding inward at the lower end thereof. And this nail
  • claw 404b can be engaged with the protrusion part 221 currently formed in the mouth part 22 of the container main body 2.
  • FIG. Thereby, the adapter 30A can be reliably engaged with the medical container 1, and the unintentional detachment from the medical container 1 is prevented.
  • the proximal-side structure 6 ⁇ / b> A includes a storage member (storage unit) 65 having a bottomed cylindrical shape that can store the entire medical container 1, and a guide unit 67. And a guide structure 63 attached to the.
  • the storage member 65 can store the medical container 1 inside thereof. Thereby, even when the medicine P is a dangerous medicine if a medical worker touches it by mistake, even if the medicine P adheres to the outer surface of the container body 2 during the manufacture of the medical container 1, for example, the storage member 65 Since the container main body 2 is covered, it is possible to prevent the surrounding contamination and to ensure the safety of the medical staff. Further, the medical container 1 can be gripped through the storage member 65 in the same manner as a conventional vial container.
  • the base end side female screw part (base end side screwing part) 651 screwed with the cap side male screw part 79 of the cap 7A is formed in the inner peripheral part of the front end of the storage member 65. Then, the cap-side male screw portion 79 and the base end-side female screw portion 651 are screwed together so that the sterilized state of the top plate 31 of the plug 3 is maintained until the medical device set 100 is used.
  • a detachment preventing portion 652 configured by a ring-shaped protrusion along the circumferential direction is provided at a portion closer to the base end side than the base end side female screw portion 651. Protrusions are formed.
  • the separation preventing portion 652 is a portion that engages with the guide structure 63 and prevents the guide structure 63 from being detached from the storage member 65.
  • a plurality of (for example, three) ribs 653 extending along the central axis O direction protrude from the inner peripheral portion of the storage member 65 at a portion closer to the base end side than the separation preventing portion 652.
  • the ribs 653 are arranged at equiangular intervals around the central axis O, respectively.
  • each rib 653 can contact
  • Each rib 653 also functions as a restricting portion that restricts rotation of the medical container 1 around the central axis O with respect to the storage member 65.
  • the inner peripheral portion of the storage member 65 has a seal portion that is deformed by being pressed by the outer peripheral portion of the cap 7 ⁇ / b> A at a portion between the proximal female screw portion 651 and the separation preventing portion 652. 654 is formed to protrude.
  • the seal portion 654 is a portion that forms a ring shape along the circumferential direction of the inner peripheral portion of the storage member 65.
  • Such a seal portion 654 ensures that the sterilized state of the top plate 31 of the stopper 3 is more reliably maintained until the medical device set 100 is used. Therefore, the seal portion 654 functions as a means for more reliably maintaining the sterilized state of the top plate 31 of the plug body 3 when the adapter unit 10 is attached to the medical container 1.
  • the guide structure 63 has a ring-shaped main body portion 631, three guide portions 67 protruding from the distal end surface of the main body portion 631, and three leg portions 634 protruding from the base end surface of the main body portion 631. is doing.
  • each rib 653 and each leg 634 functions as a restricting portion that restricts the rotation of the guide structure 63 around the central axis O relative to the storage member 65.
  • an engaging portion 633 that engages with the shoulder portion 22 of the container main body 2 is formed on the inner peripheral portion of the main body portion 631. Thereby, detachment
  • Each guide portion 67 is inserted into each guide hole 409 of the adapter 30A, and can perform guidance and rotation restriction of the adapter 30A.
  • the adapter unit 10 can be easily and reliably attached to the medical container 1 as in the first embodiment. Further, since the guide structure 63 is reliably prevented from rotating around the central axis O with respect to the storage member 65, the adapter 30 is medically attached when the cap 7A is removed as shown in FIG. Mounted on the container 1. And if the syringe 20 is connected to the adapter 30 after that, the medical container 1 can be used reliably.
  • each part which comprises an adapter unit is a thing of arbitrary structures which can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.
  • the adapter unit of the present invention may be a combination of any two or more configurations (features) of the above embodiments.
  • the number of guide portions for guiding the adapter in the base-end-side structure is three in each of the embodiments described above, but is not limited thereto, and may be one, two, four or more, for example. May be.
  • the adapter unit according to the present invention has a cylindrical shape, and is an adapter used in a mounted state mounted on a medical container including a container main body having a mouth portion at a distal end portion thereof and a soft sealing member for sealing the mouth portion.
  • a first cap-side threaded portion having a first threaded portion formed in a cylindrical shape around the central axis on the inner circumferential side of the cylindrical body,
  • a cap having a second cap-side threaded portion having a second threaded portion spirally formed around the central axis at a position different from the first cap-side threaded portion of the cylindrical body;
  • a main body having a disk-like disk part and an outer peripheral part of the disk part, the first cap side screwing
  • the adapter side screwing portion to be screwed with the portion, and the inside of the sealing member can be pierced
  • An adapter having a needle, a mounting portion to be attached to the container body, a proximal-side screwed portion to be
  • the adapter When the adapter is guided along the moving direction, the adapter is restricted from rotating together with the cap, and has a base end side structure having at least one guide portion having a long shape.
  • a pitch of the first screw portion is larger than a pitch of the second screw portion, the disc portion penetrates in a thickness direction thereof, and a guide hole into which the guide portion is inserted.
  • Having at least one slit formed around the central axis and communicating with the guide hole, and a portion surrounded by the slit and the guide hole is an elastic piece that elastically changes.
  • the adapter and the base end side structure approach each other.
  • the guide portion is pressed and elastic while the tip portion presses the elastic piece toward the tip.
  • the second cap side screw is formed by sliding toward the guide hole with respect to the deformed elastic piece, being inserted into the guide hole, and rotating the cap around the central axis in the mounted state. Release the screwing between the mating part and the base end side screwing part.
  • the adapter moves toward the base end while preventing rotation by inserting the guide portion into the guide hole, As a result, the adapter side screwing part is detached from the first cap side screwing part, the hollow needle penetrates the sealing member, and the inside of the container body communicates with the outside via the hollow needle. To do. Therefore, it can be easily and reliably attached to the medical container, and the medical container can be used reliably after the cap is removed in the attached state. Therefore, the adapter unit of the present invention has industrial applicability.
  • Adapter unit 101 Adapter assembly (1st assembly) 102 medical container assembly (second assembly) DESCRIPTION OF SYMBOLS 1 Medical container 2 Container main body 21 Mouth part 211 Protrusion part 22 Shoulder part 3 Plug body (sealing member) 31 Top plate 311 Base end surface 312 Front end surface 6 Base end side structure 61 Base portion 611 Rib 62 Disc portion (base end side disc portion) 621 Projection 63 Guide structure 631 Main body portion 633 Engagement portion 634 Leg portion 64 Connection portion 641 Columnar portion 65 Storage member (storage portion) 651 Proximal female screw part (proximal screw part) 652 Detachment prevention part 653 Rib 654 Seal part 66 Mounting part 661 Projection piece 662 Claw 67 Guide part 671 Tip 68 Engagement part 681 Projection piece 682 Claw 69 Base end side male screw part (base end side screwing part) 691 Groove 7 Cap (tip side structure) 73 Cap-side female

Abstract

La présente invention concerne une unité adaptatrice (10) utilisée à l'état monté sur un récipient à usage médical (1). Ladite unité adaptatrice comprend : un bouchon (7) ; un adaptateur (30) comportant une partie en forme de plaque circulaire (403) comprenant une section élastique (407) ; et une structure située du côté de la base (6) comportant une section de guidage (67) destinée à guider l'adaptateur (30). Lors du montage de l'unité adaptatrice (10), on procède à une opération d'assemblage. Ladite opération d'assemblage est réalisée de façon à ce que le bouchon (7) d'un ensemble, ensemble obtenu par assemblage du bouchon (7) et de l'adaptateur (30), et la structure située du côté de la base (6) soient rendus solidaires par vissage. Lors de cette opération, la section de guidage (67) appuie, au niveau de son extrémité avant (671) sur la section élastique (407) pour la faire avancer vers l'extrémité avant et coulisse en direction d'un orifice de guidage (409) du fait de la déformation élastique subie par la section élastique (407) sous l'effet de la pression appliquée par la section de guidage (67). Ainsi, la section de guidage (67) vient se loger dans l'orifice de guidage (409).
PCT/JP2012/082214 2011-12-28 2012-12-12 Unité adaptatrice WO2013099610A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2011289188 2011-12-28
JP2011-289188 2011-12-28

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016120155A1 (fr) * 2015-01-26 2016-08-04 Bayer Pharma Aktiengesellschaft Dispositif pour transférer un liquide entre un réservoir et au moins un autre récipient d'utilisation
CN106232082A (zh) * 2014-04-16 2016-12-14 贝克顿迪金森有限公司 带有能够轴向地和可旋转地运动的部分的流体输送装置
US11224555B2 (en) 2018-04-23 2022-01-18 Hospira, Inc. Access and vapor containment system for a drug vial and method of making and using same

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Publication number Priority date Publication date Assignee Title
JP2001161792A (ja) * 1999-10-20 2001-06-19 Becton Dickinson & Co 瓶および医療容器用の移送セット
JP2001508680A (ja) * 1997-01-24 2001-07-03 スミスクライン・ビーチャム・バイオロジカルス（ソシエテ・アノニム） 新規デバイス
JP2005525971A (ja) * 2002-02-20 2005-09-02 ビオドム 容器とコンテナとの間を接続するためのデバイスおよびこのデバイスを備えるすぐに使用可能なアセンブリ
WO2007068825A1 (fr) * 2005-12-14 2007-06-21 Biocorp Recherche Et Developpement Dispositif de connexion a fonctionnement securise entre deux recipients
JP2011224223A (ja) * 2010-04-21 2011-11-10 Terumo Corp 医療用具接続具および薬剤投与具

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001508680A (ja) * 1997-01-24 2001-07-03 スミスクライン・ビーチャム・バイオロジカルス（ソシエテ・アノニム） 新規デバイス
JP2001161792A (ja) * 1999-10-20 2001-06-19 Becton Dickinson & Co 瓶および医療容器用の移送セット
JP2005525971A (ja) * 2002-02-20 2005-09-02 ビオドム 容器とコンテナとの間を接続するためのデバイスおよびこのデバイスを備えるすぐに使用可能なアセンブリ
WO2007068825A1 (fr) * 2005-12-14 2007-06-21 Biocorp Recherche Et Developpement Dispositif de connexion a fonctionnement securise entre deux recipients
JP2011224223A (ja) * 2010-04-21 2011-11-10 Terumo Corp 医療用具接続具および薬剤投与具

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106232082A (zh) * 2014-04-16 2016-12-14 贝克顿迪金森有限公司 带有能够轴向地和可旋转地运动的部分的流体输送装置
CN106232082B (zh) * 2014-04-16 2019-03-12 贝克顿迪金森有限公司 带有能够轴向地和可旋转地运动的部分的流体输送装置
WO2016120155A1 (fr) * 2015-01-26 2016-08-04 Bayer Pharma Aktiengesellschaft Dispositif pour transférer un liquide entre un réservoir et au moins un autre récipient d'utilisation
US11224555B2 (en) 2018-04-23 2022-01-18 Hospira, Inc. Access and vapor containment system for a drug vial and method of making and using same

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