WO2013172449A1 - Needle equipped connecting member, and drug dissolution kit - Google Patents

Needle equipped connecting member, and drug dissolution kit Download PDF

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Publication number
WO2013172449A1
WO2013172449A1 PCT/JP2013/063788 JP2013063788W WO2013172449A1 WO 2013172449 A1 WO2013172449 A1 WO 2013172449A1 JP 2013063788 W JP2013063788 W JP 2013063788W WO 2013172449 A1 WO2013172449 A1 WO 2013172449A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
connecting member
chemical solution
hollow needle
elastic sheath
Prior art date
Application number
PCT/JP2013/063788
Other languages
French (fr)
Japanese (ja)
Inventor
宏哉 岩堀
Original Assignee
味の素株式会社
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 味の素株式会社 filed Critical 味の素株式会社
Priority to CN201380024984.0A priority Critical patent/CN104271104B/en
Priority to KR20147033447A priority patent/KR20150014474A/en
Priority to JP2013527196A priority patent/JP6234225B2/en
Priority to KR1020187009299A priority patent/KR20180037071A/en
Publication of WO2013172449A1 publication Critical patent/WO2013172449A1/en
Priority to IN9433DEN2014 priority patent/IN2014DN09433A/en
Priority to PH12014502543A priority patent/PH12014502543A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A61J1/1481—Inlet or outlet ports with connection retaining means, e.g. thread or snap-fit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • 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
    • A61J1/2055—Connecting means having gripping means
    • 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
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix 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
    • A61J1/2096—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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D47/00—Closures with filling and discharging, or with discharging, devices
    • B65D47/04—Closures with discharging devices other than pumps
    • B65D47/20—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge
    • B65D47/2018—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge comprising a valve or like element which is opened or closed by deformation of the container or closure
    • B65D47/2056—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge comprising a valve or like element which is opened or closed by deformation of the container or closure lift valve type
    • B65D47/2081—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge comprising a valve or like element which is opened or closed by deformation of the container or closure lift valve type in which the deformation raises or lowers the valve port
    • B65D47/2087—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge comprising a valve or like element which is opened or closed by deformation of the container or closure lift valve type in which the deformation raises or lowers the valve port the port being formed by a slidable rigid cap-like element which is moved linearly by the pressure of the contents
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/18—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
    • B65D81/20—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S215/00—Bottles and jars
    • Y10S215/03—Medical

Definitions

  • the present invention relates to a connecting member with a needle configured so that another vial can be connected to a chemical solution container, and a drug dissolution kit in which the connecting member with a needle and the chemical solution container are connected.
  • Patent Documents 1 to 3 Conventionally, as a chemical solution dissolution kit, for example, techniques disclosed in Patent Documents 1 to 3 have been proposed.
  • Patent Document 1 includes a glaze solution container and a vial holder.
  • the drug solution container has a communication port formed in the upper part of the container body and a discharge port for the drug solution formed in the lower part.
  • a coupling member is formed at the upper end of the communication port.
  • the vial holder is provided with a vial mounting port and a medical needle projecting from the bottom inner surface of the holder body, and the bottom of the holder body and the chemical container are connected to each other.
  • a drug dissolution kit characterized in that members are combined is disclosed.
  • Patent Document 2 includes a plastic solution liquid container main body having a mouth that is closed by a heel seal part and having an upper part, and a pair of upper and lower needle bodies each having a hollow part communicating therewith.
  • a double-ended needle positioned above the mouth, a drug vial having a mouth positioned above the double-ended needle and sealed at the lower end, and the double-ended needle concentrically surrounding the lysate container mouth
  • a protective cap that extends upward so as to cover the drug vial and can be appropriately removed from the mouth
  • the needle body of the double-ended needle has a mouth seal part of the drug vial in the protection cap Is pressed against the upper needle body, sliding with respect to the protective cap, puncturing the mouth seal portion of the dissolution liquid container with the lower needle body, and mouth seal of the drug vial with the upper needle body Piercing the part
  • the length is such that the medicine in the container can be moved downward through the needle body each time the container is inserted into both containers by being upside down and turned upside down.
  • Patent Document 3 discloses an infusion container having a flexible plastic container body in which a chemical solution such as a solution or a diluent is enclosed, and a means for communicating with another chemical solution container and a chemical solution outlet.
  • the communication means is a combination of a puncture needle that communicates with the inside of the container body and that can be punctured into the mouth of another drug container, and is concentrically integrated with the puncture needle.
  • the puncture needle is covered with a protective cap having a rubber inner layer made of a rubber member, and in this crowned state, the rubber inner layer of the protective cap is the puncture needle.
  • a restraining mechanism is formed between the protective cap and the communication means to restrain the protective cap in a crowned state, and a sealing mechanism is formed around the needle to keep the puncture needle sterile and liquid-tight.
  • the protective carrier The rotation of flops, infusion container, characterized in that it is configured to be taken selectively a restricting position and the non-arresting position is disclosed.
  • the above-described conventional technique has the following problems.
  • the needle part which is an assembly of a plurality of molded articles, is connected, it is difficult to guarantee the sterilization of the needle part in the sterilization process of the dissolution liquid part, and even a single needle is gamma sterilized. Therefore, there is a problem that the manufacturing cost becomes high.
  • the solution container with a double-ended needle described in Patent Document 2 has to be punctured by both double-ended needles in the stoppers of both the vial and the chemical solution, and the operation is troublesome. In addition, there are two opportunities for coring. Further, there is a problem that the cost is high due to the complicated structure.
  • the infusion container described in Patent Document 3 is a drug dissolution kit that exposes the needle before removing the needle cap and piercing the stopper of the vial. If the needle is exposed first, sterilization is guaranteed. There is a problem that it is not. Moreover, there is a problem such as danger because the needle tip is exposed.
  • This invention is made in view of the said situation, and makes it a subject to provide the connection member with a needle
  • the present invention includes, for example, a member main body in which a hollow needle is erected and an elastic sheath covering the hollow needle, and is opposite to the side of the member main body in which the hollow needle is erected.
  • a connecting member with a needle provided with a chemical container connecting portion configured to be connected to the chemical container on the surface side, wherein the elastic sheath body is in close contact with at least the outer surface of the hollow needle so as to be peeled off.
  • a connecting member with a needle characterized by being covered in a state.
  • the elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method.
  • the connecting member with a needle of the present invention it is preferable that at least the outer surface of the hollow needle covered with the elastic sheath body is guaranteed to be sterilized.
  • a flat portion is formed at the tip of the elastic sheath body.
  • the member body has a flange-shaped base portion having a flange portion that spreads from a peripheral edge of the base portion of the hollow needle, and the base portion of the elastic sheath body extends along the surface of the flange portion. It is preferable to have.
  • the chemical solution container connecting portion has a connecting pipe portion connectable with a tubular connecting portion provided in the chemical solution container to be connected.
  • a vial engaging portion to which a mouth portion of the vial is attached is provided on the surface side of the member main body where the hollow needle is erected.
  • the chemical solution container connecting portion may have a connection screw portion that can be screwed to a tubular screw portion provided in the chemical solution container to be connected.
  • the present invention includes the connecting member with a needle and a chemical liquid container provided with a tubular connecting part, and the connecting pipe part provided in the connecting member with the needle and the tubular connecting part of the chemical liquid container can flow the chemical liquid.
  • a drug dissolution kit characterized by being connected is provided.
  • the present invention includes the connecting member with a needle and a chemical liquid container provided with a tubular screw part, and the connecting screw part provided in the connecting member with a needle and the tubular screw part of the chemical liquid container can flow the chemical liquid.
  • a drug dissolution kit characterized by being screwed.
  • the chemical solution container is preferably provided with a chemical solution outlet for allowing the contained chemical solution to flow out.
  • a hanging tool configured to suspend and support the drug dissolution kit is provided on the connecting member with a needle or the chemical solution container.
  • the present invention also includes the connection member with a needle and a chemical liquid container provided with a tubular screw portion, and is connected so that the connection screw portion provided in the connection member with a needle and the tubular screw portion of the chemical liquid container can be attached and detached.
  • the drug dissolution kit is characterized in that both the connecting screw portion and the tubular screw portion are luer lock type.
  • the present invention has the following aspects.
  • a member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container, The elastic sheath body covers at least the outer surface of the hollow needle so as to be able to peel off, and a connecting member with a needle,
  • the connecting member with a needle according to (1), wherein the elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method (3)
  • the member main body has a flange portion that spreads from the periphery of the base portion of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion.
  • a connecting member with a needle as described in (8) On the surface side of the member body where the hollow needle is erected, a vial engaging portion configured to be fitted with a mouth portion of a vial is provided.
  • (1) to (7 ) A connecting member with a needle according to any one of (9) Any one of (1) to (8), wherein the chemical solution container connection portion has a connection screw portion configured to be screwed to a tubular screw portion provided in the chemical solution container to be connected.
  • the connecting member with a needle according to item (10) A connection member with a needle according to any one of (1) to (8) and a chemical solution container provided with a tubular connection part, and a connection pipe part provided in the connection member with a needle; A drug dissolution kit, connected to the tubular connection part of the drug solution container so that the drug solution can circulate; (11) The connecting member with a needle according to (9) and a chemical liquid container provided with a tubular screw part, wherein the connecting screw part provided in the connecting member with a needle and the tubular screw part of the chemical liquid container are chemicals Drug dissolution kit, connected by screwing, so that can be distributed (12) The drug solution kit according to (10) or (11), wherein the drug solution container is provided with a drug solution outlet for allowing the contained drug solution to flow out.
  • the connecting member with a needle according to (9) and a chemical liquid container provided with a tubular screw part, the connecting screw part provided in the connecting member with a needle and the tubular screw part of the chemical liquid container; Are connected so as to be detachable, and both the connecting screw portion and the tubular screw portion are luer lock type.
  • the connecting member with a needle includes a member main body in which a hollow needle is erected and an elastic sheath body that covers the hollow needle, and the surface of the member main body opposite to the side in which the hollow needle is erected.
  • the outer surface of the hollow needle covered by at least the elastic sheath can be sterilized by molding the elastic sheath by bringing the molten resin into close contact with the outer surface of the hollow needle, Since this part can be assured of sterilization, the sterilization process can be easily performed when used as a drug dissolution kit.
  • the drug dissolution kit of the present invention is configured to connect the drug solution container connecting portion of the connecting member with a needle to the drug container, at least the outer surface of the hollow needle covered with the elastic sheath body can guarantee sterilization.
  • a sterilization step can be easily performed.
  • FIG. 1 is a view showing a first example of a connecting member with a needle of the present invention.
  • the connecting member with a needle 1 of this example includes a member main body 3 in which a hollow needle 2 is erected and an elastic sheath body 4 that covers the hollow needle 2, and the hollow needle 2 of the member main body 3 is erected.
  • a vial engaging portion 8 configured to be fitted with the mouth portion 7 of the vial 6 is provided, and on the other surface side of the member main body 3, a drug solution container can be connected.
  • the connecting tube portion 12 (chemical solution container connecting portion) configured as described above is provided, and the elastic sheath body 4 covers at least the outer surface of the hollow needle 2 in a close contact state so as to be peeled off. .
  • the member main body 3 has a flange portion 11 that spreads from the periphery of the base portion of the hollow needle 2, and a base portion of the elastic sheath body 4 has a flange-like base portion 13 that extends along the surface of the flange portion 11. ing.
  • the flange-like base portion 13 that extends along the surface of the flange portion 11 in this way, when the vial 6 is attached, the top surface of the mouth portion 7 made of an aluminum cap or the like and the flange-like base portion made of an elastic resin. 13, the flange-like base portion 13 acts as a packing, and liquid leakage from this portion can be prevented.
  • the base portion of the hollow needle 2 indicates a root portion of the hollow needle 2 having the through hole 5 at the tip portion, and is a portion located at the center portion of the flange portion 11.
  • the base portion of the elastic sheath body 4 indicates an elastic sheath body portion at the upper part of the base portion of the hollow needle 2 and is a portion located at the center of the elastic sheath body 4 of the flange portion 11.
  • a vial engaging portion 8 including two or more protruding pieces 9 protruding upward from the peripheral edge of the flange portion 11 is provided on one surface side of the member body 3 where the hollow needle 2 is erected. It has been. As shown in FIG. 3, these protrusions 9 are formed with locking claws 10 that engage with the mouth portion 7 of the vial 6 when the vial 6 is attached to the connecting member 1 with a needle.
  • the member body 3 and the hollow needle 2 are integrally molded products of synthetic resin.
  • synthetic resin since it is important to maintain the shape even when inserted into the stopper of the vial 6, polyethylene, polypropylene, polycarbonate, ABS resin, and AS resin are used as resins having high rigidity suitable for the Japanese Pharmacopoeia. Etc. are preferably used, and polypropylene is more preferred.
  • the hollow needle 2 only needs to be configured so as to be able to puncture the stopper provided in the mouth portion 7 of the vial 6, and the dimensions and the tip shape are not particularly limited.
  • the diameter ⁇ a of the hollow needle 2 is preferably about 2.5 to 3.5 mm
  • the cylindrical part length b is preferably about 7.0 to 8.0 mm.
  • the height c is preferably about 15 to 17 mm.
  • the through-hole 5 drilled in the hollow needle 2 is configured such that one end opens at the tip of the hollow needle 2 and the other end opens on the other surface side of the member main body 3 so that the drug solution can flow. It has a hole diameter.
  • the material of the elastic sheath 4 is a resin conforming to the Japanese Pharmacopoeia, and an injectable thermoplastic elastomer can be used.
  • Styrene-ethylene-butylene-styrene block copolymer SEBS
  • styrene-ethylene- Block copolymer consisting of propylene-styrene block copolymer (SEPS), hydrogenated styrene-butadiene rubber (HSBR), styrene-ethylene-butadiene rubber (SEBR), or crystalline polyolefin block-ethylene block-butylene block-crystalline polyolefin block
  • CEBC combination
  • EVOH ethylene / vinyl alcohol copolymer
  • polyethylene polyethylene
  • SEBS styrene-ethylene-butylene-styrene block copolymer
  • EOH ethylene / vinyl alcohol copolymer
  • PE polyethylene
  • the elastic sheath body 4 covers the outer surface of the hollow needle 2 and is formed along the upper surface of the flange portion 11 of the member main body 3.
  • the distal end of the elastic sheath body 4 is a flat surface portion 14 formed in a flat shape without matching the needle tip shape of the hollow needle 2.
  • the thickness of the elastic sheath body 4 covering the needle tip of the hollow needle 2 is such that the needle tip does not protrude carelessly and does not become a resistance when puncturing the stopper of the vial 6. Is preferably from 1 mm to 10 mm, more preferably from 1 mm to 5 mm.
  • the tip of the elastic sheath body 4 uses a resistance generated when the vial 6 is mounted, and the elastic sheath body 4 is peeled off, so that the portion having the flat portion 14 that does not enter the vial 6 and receives the mounting resistance is used. Show.
  • the elastic sheath body 4 is peeled off from the distal end portion of the hollow needle 2 when the vial 6 is attached to the vial engaging portion 8.
  • the operation of breaking through the flat surface portion 14 of the elastic sheath 4 and piercing the stopper of the vial 6 and entering the inside of the vial 6 is performed smoothly.
  • the elastic sheath body 4 may enter the inside of the vial 6 without being peeled off from the hollow needle 2. In order to prevent this, it is preferable that the outer diameter of the flat portion 14 is not less than the diameter a of the hollow needle 2.
  • the connecting member 1 with a needle of this example is preferably manufactured by a two-color molding method using the resin material of the member main body 3 including the hollow needle 2 and the resin material of the elastic sheath body 4.
  • the two-color molding method is a molding technique in which different materials (materials) are combined and molded integrally.
  • the two-color molding method in the manufacturing method of the connecting member 1 with a needle of this example is to mold the member main body 3 including the hollow needle 2 and within the same mold as the hollow needle 2 after the molding of the member main body 3. This includes forming the elastic sheath body 4 integrally with the member main body 3.
  • the method of manufacturing the elastic sheath body 4 includes putting the hollow needle 2 into the cavity that becomes the elastic sheath body 4 while rotating the mold while the molded member main body 3 remains in the same core as the hollow needle 2, and This includes pouring the material to be the elastic sheath body 4 from the gate opening of the cavity of the elastic sheath body 4.
  • the connecting member with a needle 1 of this example is a product in which the member main body 3 including the hollow needle 2 and the elastic sheath body 4 are integrated.
  • the molding order is not limited to this, and the elastic sheath body 4 side can be molded first.
  • hook of this application it can also manufacture by an insert molding method other than the method shown above.
  • the member main body 3 is first formed, the member main body 3 is attached to the cavity of the elastic sheath body 4, and different materials (or different materials) are integrally formed.
  • the insert molding method only the member main body 3 can be molded first and left.
  • silicone oil can be applied to the surface of the hollow needle 2 before being integrated with the elastic sheath body 4 in order to further enhance the peeling effect of the elastic sheath body 4.
  • the silicone oil is preferably applied to the surface portion including the tip of the hollow needle 2 excluding the flange portion 11, and the elastic sheath body 4 is not applied to the flange portion 11 by applying silicone oil. Can be prevented from peeling off.
  • the molding condition of the member body 3 including the hollow needle 2 is within a range of a resin temperature of 180 to 300 ° C.
  • the molding conditions of the elastic sheath body 4 are preferably in the range of the resin temperature of 150 to 250 ° C.
  • the stretchability and peelability of the connecting member with needle were subjected to sensory evaluation by actually attaching the connecting member 3 with needle and the vial 6.
  • the elastic sheath body 4 and the hollow needle 2 are peeled off, it is necessary to insert only the hollow needle 2 into the vial 6 while the elastic sheath body 4 and the hollow needle 2 are peeled off.
  • the stretchability of the connecting member 3 with a needle in this case means whether the elastic sheath body 4 can be easily compressed into the gap when the connecting member 3 with the needle and the vial 6 are attached.
  • the stretchability of the connecting member 3 with a needle was evaluated according to the following criteria. A: It can be easily compressed.
  • B Although compressible, the pressing energy at the time of wearing is required compared with A.
  • C The elastic sheath body 4 is hard and compression is difficult.
  • the peelability of the connecting member 3 with a needle was evaluated according to the following criteria.
  • the connecting member 1 with a needle is manufactured by the two-color molding method or the insert molding method, a molten needle is supplied to the outer surface of the hollow needle 2 of the member main body 3 to mold the elastic sheath body 4, thereby forming a hollow needle.
  • the outer surface of 2 comes into contact with the molten resin, the temperature becomes high, and at least the outer surface of the hollow needle 2 is in a sterilized state. Therefore, the obtained connecting member 1 with a needle can ensure that at least the outer surface of the hollow needle 2 is sterilized if the elastic sheath 4 is intact.
  • Sterilization is what is called reducing the probability that microorganisms will survive in an object to be sterilized to 1 / 1,000,000 or less (that is, 1 object or less to be sterilized out of 1 million objects to be sterilized). is there.
  • the elastic sheath body 4 is formed by bringing a molten high-temperature elastic resin into contact with the outer surface portion of the molded hollow needle 2, at least the outer surface of the hollow needle 2 is sterilized to achieve a so-called aseptic condition. can do. That is, at least the outer surface of the hollow needle 2 can be assured.
  • a through hole 5 is set at the tip of the hollow needle 2, and the chemical solution and the outer surface of the hollow needle 2 come into contact through the through hole 5.
  • Sterilization of the present application is to reduce the probability of survival of an object to be sterilized, that is, at least microorganisms adhering to the outer surface of the hollow needle 2 by placing the connecting member with a needle 1 in the above-described situation.
  • FIG. 3 is a view showing a state when the vial 6 containing a medicine is attached to the connecting member 1 with a needle.
  • a vial bottle having a stopper that can be punctured on the top surface of the mouth 7, which is normally used in the medical field, can be used.
  • the stopper on the top surface of the mouth portion 7 of the vial 6 is exposed, and the mouth portion 7 is pushed into the vial engaging portion 8 of the connecting member 1 with a needle. Easy to install.
  • the stopper of the vial 6 When the vial body is attached, when the stopper of the vial 6 is brought into contact with the needle tip of the hollow needle 2 via the elastic sheath body 4 and a pressing force is applied thereto, the stopper body is connected to the hollow needle 2 via the elastic sheath body 4. Hit the tip of the needle. Further, due to the pressing force applied to the needle tip of the hollow needle 2, the elastic sheath body 4 is peeled from the outer surface of the distal end portion of the hollow needle 2, the needle tip of the hollow needle 2 breaks through the elastic sheath body 4, and further punctures the plug body. Inserted into the vial 6.
  • the mouth portion 7 of the vial 6 advances to the flange portion 11 side while spreading two or more projecting pieces 9 outward, and the respective engaging claws 10 get over the mouth portion 7 to reach the mouth reduced diameter portion. Thereafter, each protrusion 9 is elastically restored, and each engaging claw 10 is engaged with the mouth to hold the vial 6.
  • the hollow needle 2 penetrates the stopper and reaches the inside of the vial 6, and is connected to the inside of the vial 6 through the through hole 5 of the hollow needle 2.
  • the pipe portion 12 is in communication with the inside of the pipe.
  • the connecting member 1 with a needle of this example includes a member main body 3 in which a hollow needle 2 is erected and an elastic sheath body 4 that covers the hollow needle 2, and one of the member main body 3 in which the hollow needle 2 is erected.
  • a vial engaging portion 8 configured to be fitted with the mouth portion 7 of the vial 6 is provided, and the other surface side of the member main body 3 is configured to be connected to a drug solution container. Since the connecting tube portion 12 (medical solution container connecting portion) is provided and the elastic sheath body 4 is configured to cover at least the outer surface of the hollow needle 2 so as to be peeled off, the hollow needle 2 is provided.
  • the outer surface of the hollow needle 2 covered with at least the elastic sheath body 4 can be sterilized by molding the elastic sheath body 4 by bringing the molten resin into close contact with the outer surface of the hollow needle. Because this part can be sterilized, it can be used as a drug dissolution kit. It is possible to perform the sterilization process easily.
  • FIG. 4 is a view showing a second example of the connecting member with a needle of the present invention.
  • the connecting member 17 with a needle of this example is configured to include substantially the same components as the connecting member 1 with a needle of the first example described above, and the same components are denoted by the same reference numerals.
  • the connecting member 17 with a needle of this example is provided with a connecting screw part 15 in which a screw part 16 (male thread) is formed on the outer peripheral surface of the tubular body, instead of the connecting pipe part 12, as a chemical container connecting part. It is characterized by.
  • connection screw portion 15 is formed by screwing the connection screw portion 15 onto the tubular screw portion of the chemical solution container, thereby connecting the connection member 17 with the needle and the chemical solution. Connect the container so that it can be removed.
  • the screwing of the connection screw portion 15 to the tubular screw portion of the chemical liquid container means that the connection screw portion 15 is screwed into the tubular screw portion of the chemical liquid container.
  • the screw portion 16 that is a male screw is formed on the outer peripheral surface of the connection screw portion 15, but it is adapted to a chemical solution container in which a male screw is formed on the tubular screw portion.
  • the connecting screw portion 15 may be provided with a connecting screw portion in which a female screw is formed on the inner peripheral surface of the tubular body.
  • the connecting member 17 with the needle of this example can obtain substantially the same effect as the connecting member 1 with the needle of the first example described above, and can further be connected to the tubular screw portion of the chemical container so as to be detachable. With this configuration, it is possible to expand the usage forms of the drug dissolution kit, such as enabling replacement and replacement of the chemical solution container.
  • FIG. 5 is a diagram showing a first example of the drug dissolution kit of the present invention.
  • the drug dissolution kit 20 of the present example includes the above-described connecting member 1 with a needle and a chemical solution container 22, and the connecting pipe portion 12 provided on the connecting member 1 with a needle and the tubular connecting portion 21 of the chemical solution container 20 are connected to each other. It has been configured.
  • the chemical solution container 22 is formed by sealing and filling a chemical resin container body 23 with a chemical solution 23.
  • the tubular connection portion 21 is provided at one end of the container body, and a needle is attached to the distal end of the tubular connection portion 21.
  • the connecting member 1 is welded and joined.
  • the other end of the container main body is provided with a chemical liquid outlet 25 for allowing the stored chemical liquid 23 to flow out, and a stopper 26 is provided at the opening of the chemical liquid outlet 25.
  • the connecting pipe portion 12 of the connecting member with needle 1 and the tubular connecting portion 21 of the chemical solution container 20 are welded and joined at the joint portion 24.
  • the connecting pipe portion 12 of the connecting member 1 with the needle and the tubular connecting portion 21 of the chemical solution container 20 are made of the same kind of synthetic resin, for example, polypropylene, the end portions of the connecting pipe portion 12 and the tubular connecting portion 21 are used. They can be melted together and welded easily.
  • the method for connecting the connecting pipe portion 12 and the tubular connecting portion 21 is not limited to welding joining, and may be a connecting method using an appropriate connecting member such as a joint member.
  • FIG. 6 is a diagram showing a manufacturing process of the drug dissolution kit 20 of this example.
  • the connecting member 1 with a needle and the chemical solution container 22 are separately formed and prepared (FIG. 6 (a)).
  • the chemical solution container 22 is empty without the chemical solution 23, and the chemical solution outlet 25 is open.
  • FIG.6 (b) each edge part of the tubular connection part 21 of the chemical
  • the chemical liquid 23 is injected into the container from the chemical liquid outlet 25 of the chemical liquid container 22, and then a sealing body 26 is attached to the opening of the chemical liquid outlet 25 as shown in FIG. 22 is sealed. Thereby, the medicine dissolution kit 20 is produced.
  • the manufacturing process of the medicine dissolution kit 20 is not limited to the manufacturing process shown in FIG. 6.
  • the sealing member 26 is attached to the chemical liquid container 22, the chemical liquid is filled from the tubular connection part 21, and the connecting member 1 with a needle is attached. A process of connecting may be used.
  • the drug dissolution kit 20 is sterilized (FIG. 6D).
  • the chemical solution stored in the chemical solution container 22 is sterilized by a sterilization process such as high-pressure steam sterilization. At this time, since the inside of the chemical solution container 22 and the through-hole 5 of the hollow needle 2 communicate with each other, the inside of the hollow needle 2 is sterilized simultaneously with the sterilization of the chemical solution 23.
  • FIG. 7 is a diagram showing a method of using the drug dissolution kit 20 in a medical facility or the like.
  • This drug dissolution kit 20 is formed by pushing the mouth 7 of the vial 6 in which the desired drug 18 is sealed into the hollow needle 2 side of the connecting member 1 with a needle shown in FIG. And the inside of the chemical liquid container 22 communicate with each other, so that the medicine 18 and the chemical liquid 23 can be mixed.
  • FIG. 7B when the mouth portion 7 of the vial 6 is pushed in, the stopper of the vial 6 comes into contact with the tip of the hollow needle 2 via the elastic sheath body 4 so that the pressing force is applied. When applied, the stopper hits the tip of the hollow needle 2 through the elastic sheath 4.
  • the elastic sheath body 4 is peeled from the outer surface of the distal end portion of the hollow needle 2, the needle tip of the hollow needle 2 breaks through the elastic sheath body 4, and further punctures the plug body. Then, the hollow needle 2 is inserted into the vial 6.
  • the drug solution kit 20 is directed upward to inject the drug solution 23 into the vial 6.
  • the drug 18 contained in the vial 6 is dissolved (or dispersed) by the drug solution injected into the vial 6, and then the drug dissolution kit 20 is directed downward to remove the drug in the vial 6.
  • the contained chemical liquid moves into the chemical liquid container 22 through the through hole 5.
  • the drug solution 23 containing the drug 18 is supplied to the patient's body or the like through a liquid guide line or the like that is pierced through the stopper 26 of the drug solution container 22.
  • the drug dissolution kit 20 has a configuration in which the connecting member 1 with the needle is connected to the drug container 22, at least the outer surface of the hollow needle 2 covered by the elastic sheath body 4 can be guaranteed sterilization. When using as 20, a sterilization process can be performed simply.
  • FIG. 8 is a view showing an example provided with a lifting tool 27 configured to suspend and support the drug dissolution kit 20 described above.
  • a synthetic resin band-shaped lifting tool 27 is used, and both ends of the lifting tool 27 are attached to the outer surface of the member body 3 of the connecting member 1 with a needle.
  • the joining position of the hanger 27 is not limited to this example, and the hanger 27 may be joined to the chemical solution container 22 side, or hanger having various shapes other than the band shape may be used.
  • FIG. 9 is a diagram illustrating a first example of a method for attaching the hanger 27.
  • the end of the hanger 27 is superposed on the outer surface of the member main body 3 of the connecting member 1 with the needle, the heater 28 is brought close to that portion and heated, and the end of the hanger 27 is placed on the outer surface of the member main body 3. Welding.
  • FIG. 10 is a diagram illustrating a second example of a method for attaching the hanger 27.
  • attachment holes 27a are formed at both ends of the hanger 27, and mushroom-like protrusions 29 having heads configured to be inserted into the holes 27a are formed on the outer surface of the member body 3. Keep it. Then, by inserting the protrusions 29 on the outer surface of the member main body 3 into the holes 27a of the hanger 27, both ends of the hanger 27 can be attached to the outer surface of the member main body 3 of the connecting member 1 with the needle.
  • FIG. 11 is a front sectional view showing a manufacturing process of the second example of the drug dissolution kit of the present invention.
  • the connecting member 17 with the needle shown in FIG. 4 provided with the connecting screw portion 15 and the drug solution 32 are sealed with a rubber sealing material 33.
  • the syringe 30 (chemical solution container) and the piston member 34 having the distal end inserted into the syringe 30 are configured.
  • the distal end portion of the syringe 30 is provided with a tubular screw portion 31 provided with a screw portion 31a (female screw) on the inner peripheral surface, and the connection screw portion 15 of the connecting member 17 with the needle is provided on the tubular screw portion 31.
  • connection screw portion 15 being screwed to the tubular screw portion 31 means that the connection screw portion 15 is screwed into the tubular screw portion 31 and attached.
  • a separately prepared syringe 30 and a connecting member 17 with a needle are prepared, and a connecting member with a needle is attached to the tubular screw portion 31 of the syringe 30 as shown in FIG. 17 connecting screw portions 15 are fitted and screwed by turning in a mounting direction indicated by an arrow in the figure.
  • FIG. 11 (b) after the screwing of the connecting screw portion 15 of the connecting member 17 with the needle and the tubular screw portion 31 of the syringe 30 is completed and the connecting member 17 with the needle and the syringe 30 are connected, As shown in FIG. 11 (c), a chemical solution 32 is injected into the syringe 30.
  • FIG. 11 (b) after the screwing of the connecting screw portion 15 of the connecting member 17 with the needle and the tubular screw portion 31 of the syringe 30 is completed and the connecting member 17 with the needle and the syringe 30 are connected.
  • a chemical solution 32 is injected into the syringe 30.
  • a rubber sealing material 33 is plugged into the syringe 30 to seal the chemical solution 32 in the syringe 30, and the entire kit is further heat sterilized.
  • a piston member 34 for moving the rubber sealing material 33 is attached from the rear end side of the syringe 30 to obtain a drug dissolution kit 35.
  • FIG. 12 is a diagram illustrating a method of using the drug dissolution kit 35 of this example.
  • the mouth portion 7 of the vial 6 is connected with a needle of the drug dissolution kit 35 as shown in FIG.
  • the member 17 is pushed into the vial engaging portion 8.
  • the hollow needle 2 breaks through the elastic sheath body 4 and the stopper provided on the top surface of the vial 6 and enters the vial 6.
  • the piston member 34 of the syringe 30 is pushed in to inject a part or all of the drug solution 32 into the vial 6 and shaken to dissolve the drug in the vial 6.
  • the piston member 34 of the syringe 30 is pulled, and the drug solution 32 containing the drug in the vial 30 is sucked into the syringe 30.
  • the vial 6 is removed from the vial engaging part 8 of the connection member 17 with a needle
  • the connecting member 17 with the needle is rotated in the direction of detachment from the syringe 30 and the connecting member 17 with the needle is removed from the syringe 30 (FIG. 12C).
  • the luer lock type line 36 is connected to the tubular threaded portion 31 of the syringe 30, and a chemical solution containing the drug in the syringe 30 is mixedly injected.
  • the luer lock type refers to a method of attaching in a screwed and fixed manner formed into a screwed shape in accordance with the tubular screw portion 31.
  • this medicine dissolution kit 35 has a configuration in which the connecting member 17 with a needle is connected to the syringe 30, at least the outer surface of the hollow needle 2 covered with the elastic sheath body 4 can be assured of sterilization. Can be done.
  • the drug dissolution kit 35 is configured to connect the syringe 30 that is a chemical solution container and the connecting member 17 with the needle so as to be detachable, the connecting member 17 with the needle is removed from the syringe 30 after dissolving the drug in the chemical solution.
  • the use form of the drug dissolution kit can be expanded.
  • the connecting member with a needle is: A member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle, On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
  • the elastic sheath body covers at least the outer surface of the hollow needle so that it can be peeled off,
  • the elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method or an insert molding method, At least the outer surface of the hollow needle covered by the elastic sheath body is guaranteed to be sterilized,
  • a flat portion is formed at the tip of the elastic sheath body,
  • the member main body has a flange portion that spreads from the base periphery of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion,
  • the drug dissolution kit is as follows.
  • a member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
  • the elastic sheath body covers at least the outer surface of the hollow needle so that it can be peeled off,
  • the elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method or an insert molding method, At least the outer surface of the hollow needle covered by the elastic sheath body is guaranteed to be sterilized,
  • a flat portion is formed at the tip of the elastic sheath body,
  • the member main body has a flange portion that spreads from the base periphery of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion,
  • the drug dissolution kit is as follows.
  • a member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
  • the elastic sheath body covers at least the outer surface of the hollow needle so that it can be peeled off,
  • the elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method or an insert molding method, At least the outer surface of the hollow needle covered by the elastic sheath body is guaranteed to be sterilized,
  • a flat portion is formed at the tip of the elastic sheath body,
  • the member main body has a flange portion that spreads from the base periphery of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion,
  • the drug dissolution kit is as follows.
  • a member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
  • the elastic sheath body covers at least the outer surface of the hollow needle so that it can be peeled off,
  • the elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method or an insert molding method, At least the outer surface of the hollow needle covered by the elastic sheath body is guaranteed to be sterilized,
  • a flat portion is formed at the tip of the elastic sheath body,
  • the member main body has a flange portion that spreads from the base periphery of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion,
  • the present invention relates to a connecting member with a needle configured so that another vial can be connected to the drug solution container, and a drug dissolving kit in which the connecting member with a needle and the drug solution container are connected.
  • SYMBOLS 1 Connection member with a needle, 2 ... Hollow needle, 3 ... Member main body, 4 ... Elastic sheath body, 5 ... Through-hole, 6 ... Vial bottle, 7 ... Mouth part, 8 ... Vial bottle engaging part, 9 ... Projection piece DESCRIPTION OF SYMBOLS 10 ... Engagement nail

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Abstract

Provided is a needle equipped connecting member (1), and a drug dissolution kit (35) using same, comprising a member body (3) on which a hollow needle (2) is erected, and an elastic sheath (4) for covering the hollow needle (2), and having a drug solution container connection section (12) which is disposed on a side opposite the side of the member body (3) where the hollow needle (2) is erected and which can be connected to a drug solution container (22). The needle equipped connecting member (1) is characterized in that the elastic sheath (4) covers the hollow needle (2) in a state of close contact so as to allow at least an outer surface thereof to be removed. According to the present invention, during use as the drug dissolution kit (35), a sterilization process can be easily carried out.

Description

針付き接続部材、薬剤溶解キットConnecting member with needle, drug dissolution kit
　本発明は、薬液容器に別のバイアル瓶を接続できるように構成された針付き接続部材、及び前記針付き接続部材と薬液容器とを接続した薬剤溶解キットに関する。
　本願は２０１２年５月１７日に日本に出願された、特願２０１２－１１３５１７号に基づき優先権を主張し、その内容をここに援用する。 The present invention relates to a connecting member with a needle configured so that another vial can be connected to a chemical solution container, and a drug dissolution kit in which the connecting member with a needle and the chemical solution container are connected.
This application claims priority based on Japanese Patent Application No. 2012-113517 for which it applied to Japan on May 17, 2012, and uses the content here.
　従来、薬液溶解キットとしては、例えば、特許文献１～３に開示された技術が提案されている。 Conventionally, as a chemical solution dissolution kit, for example, techniques disclosed in Patent Documents 1 to 3 have been proposed.
　特許文献１には、 薬液容器とバイアル瓶ホルダーとから構成され、薬液容器は、容器本体の上部に連通口を形成しかつ下部に薬液の排出口を形成し、前記連通口の上端に結合部材を形成し、前記排出口の下端に封止体を装着し、バイアル瓶ホルダーはホルダー本体の底部内面にバイアル瓶装着口と医療用針が突設され、前記ホルダー本体の底部と薬液容器の結合部材を結合したことを特徴とする薬剤溶解キットが開示されている。 Patent Document 1 includes a glaze solution container and a vial holder. The drug solution container has a communication port formed in the upper part of the container body and a discharge port for the drug solution formed in the lower part. A coupling member is formed at the upper end of the communication port. The vial holder is provided with a vial mounting port and a medical needle projecting from the bottom inner surface of the holder body, and the bottom of the holder body and the chemical container are connected to each other. A drug dissolution kit characterized in that members are combined is disclosed.
　特許文献２には、 シール部により閉じられた口部を、上部に有した押圧変形自在なプラスチック製の溶解液容器本体と、相連通する中空部が形成された上下一対の針体を具備して前記口部の上方に位置する両頭針と、前記両頭針の上方に位置し下端にシールされた口部を有した薬剤バイアルと、前記溶解液容器口部を同心状に囲んで前記両頭針及び薬剤バイアルを覆うように上方に延び前記口部から適宜取外し得るように装着された保護キャップとを備えており、前記両頭針の針体は、前記保護キャップ内の薬剤バイアルの口部シール部を上部の針体に押し付けることにより、前記保護キャップに対する摺動を伴って、下部の針体による前記溶解液容器の口部シール部の穿刺、及び上部の針体による前記薬剤バイアルの口部シール部の穿刺を行なって両容器内に挿入され、且つ挿入後の前記両容器を上下反転する毎に前記針体を通じて下方へ容器内の薬剤を移動させ得る長さとされていることを特徴とする両頭針付溶解液容器が開示されている。 Patent Document 2 includes a plastic solution liquid container main body having a mouth that is closed by a heel seal part and having an upper part, and a pair of upper and lower needle bodies each having a hollow part communicating therewith. A double-ended needle positioned above the mouth, a drug vial having a mouth positioned above the double-ended needle and sealed at the lower end, and the double-ended needle concentrically surrounding the lysate container mouth And a protective cap that extends upward so as to cover the drug vial and can be appropriately removed from the mouth, and the needle body of the double-ended needle has a mouth seal part of the drug vial in the protection cap Is pressed against the upper needle body, sliding with respect to the protective cap, puncturing the mouth seal portion of the dissolution liquid container with the lower needle body, and mouth seal of the drug vial with the upper needle body Piercing the part With a double-headed needle, the length is such that the medicine in the container can be moved downward through the needle body each time the container is inserted into both containers by being upside down and turned upside down. A lysate container is disclosed.
　特許文献３には、内部に溶解液又は希釈液などのような薬液が封入された可撓性プラスチック製容器本体に、他の薬液容器への連通手段と薬液取出口とをそれぞれ備えた輸液容器において、上記連通手段は、上記容器本体内に連通し且つ他の薬剤容器の口部に穿刺可能な穿刺針と、前記穿刺針に同心状に一体に組合せられていて、連通時に他の薬剤容器を支持可能な支持部材とを構成要素として含み、上記穿刺針にはゴム部材からなるゴム内層を備えた保護キャップが被冠されており、この被冠状態において保護キャップのゴム内層は上記穿刺針の周りにシールを形成して前記穿刺針を無菌並びに液密状態に保持し、保護キャップと連通手段との間には、保護キャップを被冠状態に拘束する拘束機構が備えられ、前記拘束機構は、保護キャップの回動動作により、拘束位置と非拘束位置とを選択的にとり得るよう構成されていることを特徴とする輸液容器が開示されている。 Patent Document 3 discloses an infusion container having a flexible plastic container body in which a chemical solution such as a solution or a diluent is enclosed, and a means for communicating with another chemical solution container and a chemical solution outlet. The communication means is a combination of a puncture needle that communicates with the inside of the container body and that can be punctured into the mouth of another drug container, and is concentrically integrated with the puncture needle. The puncture needle is covered with a protective cap having a rubber inner layer made of a rubber member, and in this crowned state, the rubber inner layer of the protective cap is the puncture needle. A restraining mechanism is formed between the protective cap and the communication means to restrain the protective cap in a crowned state, and a sealing mechanism is formed around the needle to keep the puncture needle sterile and liquid-tight. The protective carrier The rotation of flops, infusion container, characterized in that it is configured to be taken selectively a restricting position and the non-arresting position is disclosed.
特開平１０－３３６３５号公報Japanese Patent Laid-Open No. 10-33635 実開平６－２２２７２号公報Japanese Utility Model Publication No. 6-22272 特開平８－２４３１３号公報JP-A-8-24313
　しかしながら、前述した従来技術には、次のような問題があった。
　特許文献１に記載の薬剤溶解キットは、複数の成形品の組立品である針部が接続されているため、溶解液部の滅菌工程では、針部の滅菌保証が難しく、針単体でもガンマ線滅菌等による滅菌が必要となるため、製造コストが高くなる問題がある。
　特許文献２に記載の両頭針付溶解液容器は、両頭針をバイアル瓶と薬液容の双方の栓体に穿刺しなければならず、操作が面倒であった。また、コアリング発生の機会が２回である。さらに構造が複雑であるためコスト高となる問題がある。
　特許文献３に記載の輸液容器は、針キャップを取り外して、バイアル瓶の栓体穿刺前に、針を露出するタイプの薬剤溶解キットであり、先に針を露出させてしまうと、滅菌が保証されないという問題がある。また、針先が露出するために危険である等の問題がある。 However, the above-described conventional technique has the following problems.
In the drug dissolution kit described in Patent Document 1, since the needle part, which is an assembly of a plurality of molded articles, is connected, it is difficult to guarantee the sterilization of the needle part in the sterilization process of the dissolution liquid part, and even a single needle is gamma sterilized. Therefore, there is a problem that the manufacturing cost becomes high.
The solution container with a double-ended needle described in Patent Document 2 has to be punctured by both double-ended needles in the stoppers of both the vial and the chemical solution, and the operation is troublesome. In addition, there are two opportunities for coring. Further, there is a problem that the cost is high due to the complicated structure.
The infusion container described in Patent Document 3 is a drug dissolution kit that exposes the needle before removing the needle cap and piercing the stopper of the vial. If the needle is exposed first, sterilization is guaranteed. There is a problem that it is not. Moreover, there is a problem such as danger because the needle tip is exposed.
　本発明は、前記事情に鑑みてなされ、薬剤溶解キットとして使用する際に滅菌工程を簡便に行うことができる針付き接続部材及びそれを用いた薬剤溶解キットの提供を課題とする。 This invention is made in view of the said situation, and makes it a subject to provide the connection member with a needle | hook which can perform a sterilization process simply when using as a chemical | medical agent dissolution kit, and a chemical | medical agent dissolution kit using the same.
　前記課題を達成するため、本発明は、例えば、中空針が立設された部材本体と、前記中空針を覆う弾性鞘体とを備え、前記部材本体の中空針が立設された側と反対の面側には、薬液容器と接続できるように構成された薬液容器接続部が設けられた針付き接続部材であって、前記弾性鞘体は、少なくとも前記中空針の外面を剥離可能に密着した状態で覆っていることを特徴とする針付き接続部材を提供する。 In order to achieve the above object, the present invention includes, for example, a member main body in which a hollow needle is erected and an elastic sheath covering the hollow needle, and is opposite to the side of the member main body in which the hollow needle is erected. A connecting member with a needle provided with a chemical container connecting portion configured to be connected to the chemical container on the surface side, wherein the elastic sheath body is in close contact with at least the outer surface of the hollow needle so as to be peeled off. Provided is a connecting member with a needle characterized by being covered in a state.
　本発明の針付き接続部材において、前記中空針の外面に前記弾性鞘体を二色成形法によって設けたことが好ましい。 In the connecting member with a needle of the present invention, it is preferable that the elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method.
　本発明の針付き接続部材において、少なくとも前記弾性鞘体によって覆われた中空針の外面が、滅菌保証されていることが好ましい。 In the connecting member with a needle of the present invention, it is preferable that at least the outer surface of the hollow needle covered with the elastic sheath body is guaranteed to be sterilized.
　本発明の針付き接続部材において、前記弾性鞘体の先端に平面部が形成されていることが好ましい。 In the connecting member with a needle of the present invention, it is preferable that a flat portion is formed at the tip of the elastic sheath body.
　本発明の針付き接続部材において、前記部材本体は、前記中空針の基部周縁から広がったフランジ部を有し、かつ前記弾性鞘体の基部が前記フランジ部の面に沿って広がるフランジ状基部を有していることが好ましい。 In the connecting member with a needle according to the present invention, the member body has a flange-shaped base portion having a flange portion that spreads from a peripheral edge of the base portion of the hollow needle, and the base portion of the elastic sheath body extends along the surface of the flange portion. It is preferable to have.
　本発明の針付き接続部材において、前記薬液容器接続部が、接続する薬液容器に設けられた管状接続部と接続可能な接続管部を有していることが好ましい。 In the connecting member with a needle of the present invention, it is preferable that the chemical solution container connecting portion has a connecting pipe portion connectable with a tubular connecting portion provided in the chemical solution container to be connected.
　本発明の針付き接続部材において、前記部材本体の中空針が立設された面側には、バイアル瓶の口部が装着されるバイアル瓶係合部が設けられていることが好ましい。 In the connecting member with a needle of the present invention, it is preferable that a vial engaging portion to which a mouth portion of the vial is attached is provided on the surface side of the member main body where the hollow needle is erected.
　本発明の針付き接続部材において、前記薬液容器接続部が、接続する薬液容器に設けられた管状ネジ部に螺着可能な接続ネジ部を有している構成としてもよい。 In the connecting member with a needle of the present invention, the chemical solution container connecting portion may have a connection screw portion that can be screwed to a tubular screw portion provided in the chemical solution container to be connected.
　また本発明は、前記針付き接続部材と、管状接続部が設けられた薬液容器とを備え、針付き接続部材に設けられた接続管部と、薬液容器の管状接続部とが薬液流通可能に接続されていることを特徴とする薬剤溶解キットを提供する。 Further, the present invention includes the connecting member with a needle and a chemical liquid container provided with a tubular connecting part, and the connecting pipe part provided in the connecting member with the needle and the tubular connecting part of the chemical liquid container can flow the chemical liquid. A drug dissolution kit characterized by being connected is provided.
　また本発明は、前記針付き接続部材と、管状ネジ部が設けられた薬液容器とを備え、針付き接続部材に設けられた接続ネジ部と、薬液容器の管状ネジ部とが薬液流通可能に螺着接続されていることを特徴とする薬剤溶解キットを提供する。 Further, the present invention includes the connecting member with a needle and a chemical liquid container provided with a tubular screw part, and the connecting screw part provided in the connecting member with a needle and the tubular screw part of the chemical liquid container can flow the chemical liquid. Provided is a drug dissolution kit characterized by being screwed.
　本発明の薬剤溶解キットにおいて、前記薬液容器は、収容している薬液を流出させるための薬液流出口が設けられていることが好ましい。 In the drug dissolution kit of the present invention, the chemical solution container is preferably provided with a chemical solution outlet for allowing the contained chemical solution to flow out.
　本発明の薬剤溶解キットにおいて、前記針付き接続部材又は前記薬液容器に、薬剤溶解キットを吊下げ支持できるように構成された吊り具が設けられたことが好ましい。 In the drug dissolution kit of the present invention, it is preferable that a hanging tool configured to suspend and support the drug dissolution kit is provided on the connecting member with a needle or the chemical solution container.
　また本発明は、前記針付接続部材と、管状ネジ部が設けられた薬液容器とを備え、針付き接続部材に設けられた接続ネジ部と薬液容器の管状ネジ部とが着脱できるように接続されており、この接続ネジ部と管状ネジ部が共にルアーロック式であることを特徴とする薬剤溶解キットを提供する。 The present invention also includes the connection member with a needle and a chemical liquid container provided with a tubular screw portion, and is connected so that the connection screw portion provided in the connection member with a needle and the tubular screw portion of the chemical liquid container can be attached and detached. The drug dissolution kit is characterized in that both the connecting screw portion and the tubular screw portion are luer lock type.
　また、本発明は以下の側面を有する。
（１）中空針が立設された部材本体と、前記中空針を覆う弾性鞘体とを備え、
　前記部材本体の中空針が立設された側と反対の面側には、薬液容器と接続できるように構成された薬液容器接続部が設けられた針付き接続部材であって、
　前記弾性鞘体は、少なくとも前記中空針の外面を剥離できるように密着した状態で覆っている、針付き接続部材、
（２）前記中空針の外面に前記弾性鞘体を二色成形法によって設けた、（１）に記載の針付き接続部材、
（３）前記中空針の外面に前記弾性鞘体をインサート成形法によって設けた、（１）に記載の針付き接続部材、
（４）少なくとも前記弾性鞘体によって覆われた中空針の外面が、滅菌保証されている、（１）～（３）のいずれか１項に記載の針付き接続部材、
（５）前記弾性鞘体の先端に平面部が形成されている、（１）～（４）のいずれか１項に記載の針付き接続部材、
（６）前記部材本体は、前記中空針の基部周縁から広がったフランジ部を有し、かつ前記弾性鞘体の基部が前記フランジ部の面に沿って広がるフランジ状基部を有している、（１）～（５）のいずれか１項に記載の針付き接続部材、
（７）前記薬液容器接続部が、接続する薬液容器に設けられた管状接続部と接続できるように構成された接続管部を有している、（１）～（６）のいずれか１項に記載の針付き接続部材、
（８）前記部材本体の中空針が立設された面側には、バイアル瓶の口部が装着されるように構成されたバイアル瓶係合部が設けられている、（１）～（７）のいずれか１項に記載の針付き接続部材、
（９）前記薬液容器接続部が、接続する薬液容器に設けられた管状ネジ部に螺着できるように構成された接続ネジ部を有している、（１）～（８）のいずれか１項に記載の針付き接続部材、
（１０）（１）～（８）のいずれか１項に記載の針付き接続部材と、管状接続部が設けられた薬液容器とを備え、針付き接続部材に設けられた接続管部と、薬液容器の管状接続部とが薬液が流通できるように接続されている、薬剤溶解キット、
（１１）（９）に記載の針付き接続部材と、管状ネジ部が設けられた薬液容器とを備え、針付き接続部材に設けられた接続ネジ部と、薬液容器の管状ネジ部とが薬液が流通できるように、螺着により接続されている、薬剤溶解キット、
（１２）前記薬液容器は、収容している薬液を流出させるための薬液流出口が設けられている、（１０）又は（１１）に記載の薬剤溶解キット、
（１３）前記針付き接続部材又は前記薬液容器に、薬剤溶解キットを吊下げ支持できるように構成された吊り具が設けられた、（１０）又は（１２）に記載の薬剤溶解キット、及び
（１４）（９）に記載の針付接続部材と、管状ネジ部が設けられた薬液容器とを備え、前記針付き接続部材に設けられた前記接続ネジ部と前記薬液容器の前記管状ネジ部とが着脱できるように接続されており、この前記接続ネジ部と前記管状ネジ部が共にルアーロック式である、薬剤溶解キット。 The present invention has the following aspects.
(1) A member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle,
On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
The elastic sheath body covers at least the outer surface of the hollow needle so as to be able to peel off, and a connecting member with a needle,
(2) The connecting member with a needle according to (1), wherein the elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method,
(3) The connecting member with a needle according to (1), wherein the elastic sheath body is provided on the outer surface of the hollow needle by an insert molding method,
(4) The connecting member with a needle according to any one of (1) to (3), wherein at least an outer surface of the hollow needle covered with the elastic sheath body is guaranteed to be sterilized.
(5) The connecting member with a needle according to any one of (1) to (4), wherein a flat portion is formed at a tip of the elastic sheath body,
(6) The member main body has a flange portion that spreads from the periphery of the base portion of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion. 1) A connecting member with a needle according to any one of (5),
(7) Any one of (1) to (6), wherein the chemical solution container connection portion has a connection pipe portion configured to be connected to a tubular connection portion provided in the chemical solution container to be connected. A connecting member with a needle as described in
(8) On the surface side of the member body where the hollow needle is erected, a vial engaging portion configured to be fitted with a mouth portion of a vial is provided. (1) to (7 ) A connecting member with a needle according to any one of
(9) Any one of (1) to (8), wherein the chemical solution container connection portion has a connection screw portion configured to be screwed to a tubular screw portion provided in the chemical solution container to be connected. The connecting member with a needle according to item,
(10) A connection member with a needle according to any one of (1) to (8) and a chemical solution container provided with a tubular connection part, and a connection pipe part provided in the connection member with a needle; A drug dissolution kit, connected to the tubular connection part of the drug solution container so that the drug solution can circulate;
(11) The connecting member with a needle according to (9) and a chemical liquid container provided with a tubular screw part, wherein the connecting screw part provided in the connecting member with a needle and the tubular screw part of the chemical liquid container are chemicals Drug dissolution kit, connected by screwing, so that can be distributed
(12) The drug solution kit according to (10) or (11), wherein the drug solution container is provided with a drug solution outlet for allowing the contained drug solution to flow out.
(13) The drug dissolution kit according to (10) or (12), wherein the connecting member with a needle or the drug solution container is provided with a hanging tool configured to suspend and support the drug dissolution kit, and 14) The connecting member with a needle according to (9) and a chemical liquid container provided with a tubular screw part, the connecting screw part provided in the connecting member with a needle and the tubular screw part of the chemical liquid container; Are connected so as to be detachable, and both the connecting screw portion and the tubular screw portion are luer lock type.
　本発明の針付き接続部材は、中空針が立設された部材本体と、前記中空針を覆う弾性鞘体とを備え、前記部材本体の中空針が立設された側と反対の面側には、薬液容器と接続できるように構成された薬液容器接続部が設けられ、前記弾性鞘体は、少なくとも前記中空針の外面を剥離できるように密着した状態で覆っている構成としたものなので、中空針を覆う弾性鞘体を形成する際、溶融樹脂を中空針外面に密着させて弾性鞘体を成形することで、少なくとも弾性鞘体によって覆われた中空針の外面を滅菌することができ、この部分の滅菌が保証できることから、薬剤溶解キットとして使用する際に滅菌工程を簡便に行うことができる。 The connecting member with a needle according to the present invention includes a member main body in which a hollow needle is erected and an elastic sheath body that covers the hollow needle, and the surface of the member main body opposite to the side in which the hollow needle is erected. Is provided with a chemical solution container connecting portion configured to be connected to the chemical solution container, and the elastic sheath body is configured to cover at least the outer surface of the hollow needle so as to be peeled off, When forming an elastic sheath covering the hollow needle, the outer surface of the hollow needle covered by at least the elastic sheath can be sterilized by molding the elastic sheath by bringing the molten resin into close contact with the outer surface of the hollow needle, Since this part can be assured of sterilization, the sterilization process can be easily performed when used as a drug dissolution kit.
　本発明の薬剤溶解キットは、薬剤容器に前記針付き接続部材の薬液容器接続部を接続した構成なので、少なくとも弾性鞘体によって覆われた中空針の外面については滅菌を保証することができることから、薬剤溶解キットとして使用する際に滅菌工程を簡便に行うことができる。 Since the drug dissolution kit of the present invention is configured to connect the drug solution container connecting portion of the connecting member with a needle to the drug container, at least the outer surface of the hollow needle covered with the elastic sheath body can guarantee sterilization. When used as a drug dissolution kit, a sterilization step can be easily performed.
本発明の針付き接続部材の第１例を示す正面断面図である。It is front sectional drawing which shows the 1st example of the connection member with a needle | hook of this invention. 中空針の概要図である。It is a schematic diagram of a hollow needle. 針付き接続部材にバイアル瓶を装着する状態を示す正面断面図である。It is front sectional drawing which shows the state which attaches a vial bottle to a connection member with a needle | hook. 本発明の針付き接続部材の第２例を示す正面断面図である。It is front sectional drawing which shows the 2nd example of the connection member with a needle | hook of this invention. 本発明の薬剤溶解キットの第１例を示す正面断面図である。It is front sectional drawing which shows the 1st example of the chemical | medical agent dissolution kit of this invention. 薬剤溶解キットの製造工程を示す正面断面図である。It is front sectional drawing which shows the manufacturing process of a chemical | medical agent dissolution kit. 薬剤溶解キットの使用状態を示す正面断面図である。It is front sectional drawing which shows the use condition of a chemical | medical agent dissolution kit. 吊り具を有する薬剤溶解キットの正面断面図である。It is front sectional drawing of the chemical | medical agent dissolution kit which has a hanging tool. 吊り具の取付方法の第１例を示す正面断面図である。It is front sectional drawing which shows the 1st example of the attachment method of a hanging tool. 吊り具の取付方法の第２例を示す正面断面図である。It is front sectional drawing which shows the 2nd example of the attachment method of a hanging tool. 本発明の薬剤溶解キットの第２例の製造工程を示す正面断面図である。It is front sectional drawing which shows the manufacturing process of the 2nd example of the chemical | medical agent dissolution kit of this invention. 本発明の薬剤溶解キットの第２例の使用状態を示す正面断面図である。It is front sectional drawing which shows the use condition of the 2nd example of the chemical | medical agent dissolution kit of this invention.
　以下、図面を参照して本発明の実施形態を説明する。
　以下に説明する針付き接続部材及び薬剤溶解キットの構成は、本発明の単なる例示であり、本発明はこれらの例示に限定されるものではなく、種々の変更や修正が可能である。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.
The configurations of the connecting member with a needle and the drug dissolution kit described below are merely examples of the present invention, and the present invention is not limited to these examples, and various changes and modifications can be made.
（針付き接続部材）
　図１は、本発明の針付き接続部材の第１例を示す図である。
　本例の針付き接続部材１は、中空針２が立設された部材本体３と、前記中空針２を覆う弾性鞘体４とを備え、前記部材本体３の中空針２が立設された一方の面側には、バイアル瓶６の口部７が装着されるように構成されたバイアル瓶係合部８が設けられ、前記部材本体３の他方の面側には、薬液容器と接続できるように構成された接続管部１２（薬液容器接続部）が設けられ、前記弾性鞘体４は、少なくとも前記中空針２の外面を剥離できるように密着した状態で覆っていることを特徴としている。 (Connecting member with needle)
FIG. 1 is a view showing a first example of a connecting member with a needle of the present invention.
The connecting member with a needle 1 of this example includes a member main body 3 in which a hollow needle 2 is erected and an elastic sheath body 4 that covers the hollow needle 2, and the hollow needle 2 of the member main body 3 is erected. On one surface side, a vial engaging portion 8 configured to be fitted with the mouth portion 7 of the vial 6 is provided, and on the other surface side of the member main body 3, a drug solution container can be connected. The connecting tube portion 12 (chemical solution container connecting portion) configured as described above is provided, and the elastic sheath body 4 covers at least the outer surface of the hollow needle 2 in a close contact state so as to be peeled off. .
　本例において、前記部材本体３は、中空針２の基部周縁から広がったフランジ部１１を有し、かつ弾性鞘体４の基部がフランジ部１１の面に沿って広がるフランジ状基部１３を有している。このようにフランジ部１１の面に沿って広がるフランジ状基部１３を設けたことで、バイアル瓶６を装着した際に、アルミキャップ等からなる口部７の天面と弾性樹脂からなるフランジ状基部１３とが接触し、フランジ状基部１３がパッキンとして作用して、この部分からの液漏れを防ぐことができる。
　前記中空針２の基部とは、先端部に貫通孔５を有する中空針２の根元部を示し、フランジ部１１の中心部に位置する部位である。
　前記弾性鞘体４の基部とは、前記中空針２の基部上部の弾性鞘体部を示し、フランジ部１１の弾性鞘体４の中心部に位置する部位である。 In this example, the member main body 3 has a flange portion 11 that spreads from the periphery of the base portion of the hollow needle 2, and a base portion of the elastic sheath body 4 has a flange-like base portion 13 that extends along the surface of the flange portion 11. ing. By providing the flange-like base portion 13 that extends along the surface of the flange portion 11 in this way, when the vial 6 is attached, the top surface of the mouth portion 7 made of an aluminum cap or the like and the flange-like base portion made of an elastic resin. 13, the flange-like base portion 13 acts as a packing, and liquid leakage from this portion can be prevented.
The base portion of the hollow needle 2 indicates a root portion of the hollow needle 2 having the through hole 5 at the tip portion, and is a portion located at the center portion of the flange portion 11.
The base portion of the elastic sheath body 4 indicates an elastic sheath body portion at the upper part of the base portion of the hollow needle 2 and is a portion located at the center of the elastic sheath body 4 of the flange portion 11.
　前記部材本体３の中空針２が立設された一方の面側には、前記フランジ部１１の周縁から上方に向けて突出した２本以上の突片９からなるバイアル瓶係合部８が設けられている。
　これらの突片９には、図３に示すように針付き接続部材１にバイアル瓶６を装着する際に、バイアル瓶６の口部７に係合する係止爪１０が形成されている。 On one surface side of the member body 3 where the hollow needle 2 is erected, a vial engaging portion 8 including two or more protruding pieces 9 protruding upward from the peripheral edge of the flange portion 11 is provided. It has been.
As shown in FIG. 3, these protrusions 9 are formed with locking claws 10 that engage with the mouth portion 7 of the vial 6 when the vial 6 is attached to the connecting member 1 with a needle.
　前記部材本体３と中空針２とは、合成樹脂の一体成形品になっている。この合成樹脂としては、バイアル瓶６の栓体に刺しても形状を維持することが重要なため、日本薬局方に適合する剛性が高い樹脂として、ポリエチレン、ポリプロピレン、ポリカーボネート、ＡＢＳ樹脂、及びＡＳ樹脂等を用いることが好ましく、ポリプロピレンがより好ましい。 The member body 3 and the hollow needle 2 are integrally molded products of synthetic resin. As this synthetic resin, since it is important to maintain the shape even when inserted into the stopper of the vial 6, polyethylene, polypropylene, polycarbonate, ABS resin, and AS resin are used as resins having high rigidity suitable for the Japanese Pharmacopoeia. Etc. are preferably used, and polypropylene is more preferred.
　前記中空針２は、バイアル瓶６の口部７に設けられた栓体に対して穿刺できるように構成されていればよく、寸法や先端形状などは特に限定されない。
　一例として、図２に示すように先端部分が尖った中空円筒状の中空針２が挙げられる。
　図２に示す形状の中空針２を用いる場合、中空針２の直径φａは２．５～３．５ｍｍ程度が好ましく、円筒部分長さｂは７．０～８．０ｍｍ程度が好ましく、中空針高さｃは１５～１７ｍｍ程度とすることが好ましい。 The hollow needle 2 only needs to be configured so as to be able to puncture the stopper provided in the mouth portion 7 of the vial 6, and the dimensions and the tip shape are not particularly limited.
As an example, there is a hollow cylindrical hollow needle 2 having a pointed tip as shown in FIG.
When the hollow needle 2 having the shape shown in FIG. 2 is used, the diameter φa of the hollow needle 2 is preferably about 2.5 to 3.5 mm, and the cylindrical part length b is preferably about 7.0 to 8.0 mm. The height c is preferably about 15 to 17 mm.
　前記中空針２に穿設された貫通孔５は、中空針２の先端部に一端が開口し、部材本体３の他方の面側に他端が開口し、薬液が流通できるように構成された孔径を有している。 The through-hole 5 drilled in the hollow needle 2 is configured such that one end opens at the tip of the hollow needle 2 and the other end opens on the other surface side of the member main body 3 so that the drug solution can flow. It has a hole diameter.
　前記弾性鞘体４の材質は、日本薬局方に適合する樹脂であり、射出可能な熱可塑性エラストマーを用いることができ、スチレン－エチレン－ブチレン－スチレンブロック共重合体（ＳＥＢＳ）、スチレン－エチレン－プロピレン－スチレンブロック共重合体（ＳＥＰＳ）、水素化スチレン‐ブタジエンゴム（ＨＳＢＲ）、スチレン－エチレン－ブタジエンゴム（ＳＥＢＲ）、又は結晶ポリオレフィンブロック－エチレンブロック－ブチレンブロック－結晶ポリオレフィンブロックからなるブロック共重合体（ＣＥＢＣ）、エチレン・ビニルアルコール共重合体（ＥＶＯＨ）又は、ポリエチレン等を挙げることができる。
　前記部材本体３と中空針２の材質がポリプロピレンの場合、前記弾性鞘体４の材質は、スチレン－エチレン－ブチレン－スチレンブロック共重合体（ＳＥＢＳ）、又はその混合材料を用いることが好ましい。又は、中空針２と弾性鞘体４が適度な剥離性を有するためには、スチレン－エチレン－ブチレン－スチレンブロック共重合体（ＳＥＢＳ）にエチレン・ビニルアルコール共重合体（ＥＶＯＨ）やポリエチレン（ＰＥ）を混合することが好ましい。 The material of the elastic sheath 4 is a resin conforming to the Japanese Pharmacopoeia, and an injectable thermoplastic elastomer can be used. Styrene-ethylene-butylene-styrene block copolymer (SEBS), styrene-ethylene- Block copolymer consisting of propylene-styrene block copolymer (SEPS), hydrogenated styrene-butadiene rubber (HSBR), styrene-ethylene-butadiene rubber (SEBR), or crystalline polyolefin block-ethylene block-butylene block-crystalline polyolefin block Examples thereof include a combination (CEBC), an ethylene / vinyl alcohol copolymer (EVOH), and polyethylene.
When the material of the member body 3 and the hollow needle 2 is polypropylene, it is preferable to use styrene-ethylene-butylene-styrene block copolymer (SEBS) or a mixed material thereof as the material of the elastic sheath body 4. Alternatively, in order for the hollow needle 2 and the elastic sheath 4 to have appropriate peelability, styrene-ethylene-butylene-styrene block copolymer (SEBS), ethylene / vinyl alcohol copolymer (EVOH), polyethylene (PE ) Is preferably mixed.
　前記弾性鞘体４は、前記中空針２の外面を覆い、さらに部材本体３のフランジ部１１の上面に沿って形成されている。この弾性鞘体４の先端は、中空針２の針先形状に合わせることなく平面状に形成された平面部１４になっている。中空針２の針先を覆う弾性鞘体４の厚みは、不用意に針先が突出することがなく、またバイアル瓶６の栓体を穿刺する際に抵抗とならないような厚さとされ、通常は１ｍｍ以上１０ｍｍ以下であることが好ましく、１ｍｍ以上５ｍｍ以下がより好ましい。
　弾性鞘体４の先端とは、バイアル瓶６の装着時に生じる抵抗を利用し、弾性鞘体４を剥離するため、バイアル瓶６に進入せず、且つ装着抵抗を受け止める平面部１４を有する部位を示す。
　弾性鞘体４の先端に平面部１４を設けたことによって、バイアル瓶係合部８にバイアル瓶６を装着した際に、中空針２の先端部から弾性鞘体４が剥離し、中空針２が弾性鞘体４の平面部１４を突き破り、さらにバイアル瓶６の栓体を穿刺してバイアル瓶６内部に侵入する動作がスムーズに行われる。平面部１４を設けない、或いは平面部１４の外径が小さいと、弾性鞘体４が中空針２から剥離しないでバイアル瓶６内部に侵入する可能性がある。それを防ぐため、平面部１４の外径を中空針２の直径ａ以上とすることが好ましい。 The elastic sheath body 4 covers the outer surface of the hollow needle 2 and is formed along the upper surface of the flange portion 11 of the member main body 3. The distal end of the elastic sheath body 4 is a flat surface portion 14 formed in a flat shape without matching the needle tip shape of the hollow needle 2. The thickness of the elastic sheath body 4 covering the needle tip of the hollow needle 2 is such that the needle tip does not protrude carelessly and does not become a resistance when puncturing the stopper of the vial 6. Is preferably from 1 mm to 10 mm, more preferably from 1 mm to 5 mm.
The tip of the elastic sheath body 4 uses a resistance generated when the vial 6 is mounted, and the elastic sheath body 4 is peeled off, so that the portion having the flat portion 14 that does not enter the vial 6 and receives the mounting resistance is used. Show.
By providing the flat portion 14 at the distal end of the elastic sheath body 4, the elastic sheath body 4 is peeled off from the distal end portion of the hollow needle 2 when the vial 6 is attached to the vial engaging portion 8. However, the operation of breaking through the flat surface portion 14 of the elastic sheath 4 and piercing the stopper of the vial 6 and entering the inside of the vial 6 is performed smoothly. If the flat surface portion 14 is not provided or the outer diameter of the flat surface portion 14 is small, the elastic sheath body 4 may enter the inside of the vial 6 without being peeled off from the hollow needle 2. In order to prevent this, it is preferable that the outer diameter of the flat portion 14 is not less than the diameter a of the hollow needle 2.
　本例の針付き接続部材１は、中空針２を含む部材本体３の樹脂材料と、弾性鞘体４の樹脂材料とを用い、二色成形法によって製造することが好ましい。
　二色成形法は、異材質（材料）同士を組み合わせて一体に成形する成形技術である。本例の針付き接続部材１の製造方法における二色成形法は、中空針２を含む部材本体３を成形すること、及び、部材本体３の成形後、中空針２と同一の金型内で弾性鞘体４となる部分を部材本体３と一体で成形させることを含む。弾性鞘体４の製造方法は、成形した部材本体３を中空針２と同一のコアに残した状態で金型を回転させながら、中空針２を弾性鞘体４となるキャビティへ入れること、及び弾性鞘体４となる材料を弾性鞘体４のキャビティのゲート口から注ぐことを含む。このような二色成形法により、本例の針付き接続部材１は、中空針２を含む部材本体３と弾性鞘体４が一体化した製品となる。成形順序は、これに限らず、弾性鞘体４側を先に成形することも可能である。 The connecting member 1 with a needle of this example is preferably manufactured by a two-color molding method using the resin material of the member main body 3 including the hollow needle 2 and the resin material of the elastic sheath body 4.
The two-color molding method is a molding technique in which different materials (materials) are combined and molded integrally. The two-color molding method in the manufacturing method of the connecting member 1 with a needle of this example is to mold the member main body 3 including the hollow needle 2 and within the same mold as the hollow needle 2 after the molding of the member main body 3. This includes forming the elastic sheath body 4 integrally with the member main body 3. The method of manufacturing the elastic sheath body 4 includes putting the hollow needle 2 into the cavity that becomes the elastic sheath body 4 while rotating the mold while the molded member main body 3 remains in the same core as the hollow needle 2, and This includes pouring the material to be the elastic sheath body 4 from the gate opening of the cavity of the elastic sheath body 4. By such a two-color molding method, the connecting member with a needle 1 of this example is a product in which the member main body 3 including the hollow needle 2 and the elastic sheath body 4 are integrated. The molding order is not limited to this, and the elastic sheath body 4 side can be molded first.
　本願の針付き接続部材１の製造方法としては、前記に示した方法以外にインサート成形法で製造することもできる。
　インサート成形法の場合は、先に部材本体３を成形して、その部材本体３を弾性鞘体４のキャビティへ取り付け、異材質（又は異材料）を一体に成形する。
　前記インサート成形法では、先に部材本体３だけを成型し、取り置きすることが可能である。
　前記インサート成形法では、弾性鞘体４の剥離効果をより高めるために、弾性鞘体４と一体化する前に中空針２表面部にシリコンオイルを塗布することもできる。弾性鞘体４と部材本体３を一体化する前にシリコンオイルを塗布することは、インサート成形法においては容易に可能である（インサート成形法では部材本体３だけを事前に取り置きするため）。
　インサート成形法においてシリコンオイルを塗布する部位としては、フランジ部１１を除く中空針２の先端を含む表面部とすることが好ましく、フランジ部１１にはシリコンオイルを塗布しないことで、弾性鞘体４が剥離されないようにすることが可能である。
　この二色成形法又はインサート成形法による針付き接続部材１の製造において、中空針２を含む部材本体３の成形条件は、樹脂温度１８０～３００℃の範囲内とすることが好ましい。また、弾性鞘体４の成型条件は、樹脂温度１５０～２５０℃の範囲内とすることが好ましい。 As a manufacturing method of the connection member 1 with a needle | hook of this application, it can also manufacture by an insert molding method other than the method shown above.
In the case of the insert molding method, the member main body 3 is first formed, the member main body 3 is attached to the cavity of the elastic sheath body 4, and different materials (or different materials) are integrally formed.
In the insert molding method, only the member main body 3 can be molded first and left.
In the insert molding method, silicone oil can be applied to the surface of the hollow needle 2 before being integrated with the elastic sheath body 4 in order to further enhance the peeling effect of the elastic sheath body 4. It is possible to easily apply silicone oil before integrating the elastic sheath body 4 and the member main body 3 in the insert molding method (since only the member main body 3 is reserved in advance in the insert molding method).
In the insert molding method, the silicone oil is preferably applied to the surface portion including the tip of the hollow needle 2 excluding the flange portion 11, and the elastic sheath body 4 is not applied to the flange portion 11 by applying silicone oil. Can be prevented from peeling off.
In the manufacture of the connecting member 1 with a needle by the two-color molding method or the insert molding method, it is preferable that the molding condition of the member body 3 including the hollow needle 2 is within a range of a resin temperature of 180 to 300 ° C. The molding conditions of the elastic sheath body 4 are preferably in the range of the resin temperature of 150 to 250 ° C.
　以下にインサート成形による針付き接続部材の成形試験を行った結果を示す。
　まず中空針（ＰＰ）を射出成型し、その後、下記表１に記載の配合例の樹脂による弾性鞘体の成形を行った結果、表１に示すような剥離状態であった。 The result of the molding test of the connecting member with needle by insert molding is shown below.
First, hollow needles (PP) were injection molded, and then an elastic sheath body was molded with the resin of the blending examples shown in Table 1 below. As a result, a peeled state as shown in Table 1 was obtained.
　針付き接続部材の伸縮性及び剥離性は、針付き接続部材３とバイアル瓶６を実際に装着して官能評価を実施した。
　弾性鞘体４と中空針２が剥離する時には、弾性鞘体４と中空針２が剥離しながら、中空針２のみバイアル瓶６の内部へ挿入することが必要であり、弾性鞘体４は、バイアル瓶６の内部へ挿入せずに針付き接続部材３とバイアル瓶６の装着時の隙間に圧縮される状態となる。この場合の針付き接続部材３の伸縮性とは、針付き接続部材３とバイアル瓶６の装着時の隙間に弾性鞘体４を容易に圧縮できるかどうかを意味する。
　針付き接続部材３の伸縮性は、下記の基準で評価した。
Ａ：容易に圧縮可能となる。
Ｂ：圧縮可能ではあるが、Aに比べて、装着時の押圧エネルギーが必要となる。
Ｃ：弾性鞘体４が硬く、圧縮が大変である。 The stretchability and peelability of the connecting member with needle were subjected to sensory evaluation by actually attaching the connecting member 3 with needle and the vial 6.
When the elastic sheath body 4 and the hollow needle 2 are peeled off, it is necessary to insert only the hollow needle 2 into the vial 6 while the elastic sheath body 4 and the hollow needle 2 are peeled off. Without being inserted into the inside of the vial 6, the connecting member 3 with the needle and the vial 6 are compressed into the gap at the time of mounting. The stretchability of the connecting member 3 with a needle in this case means whether the elastic sheath body 4 can be easily compressed into the gap when the connecting member 3 with the needle and the vial 6 are attached.
The stretchability of the connecting member 3 with a needle was evaluated according to the following criteria.
A: It can be easily compressed.
B: Although compressible, the pressing energy at the time of wearing is required compared with A.
C: The elastic sheath body 4 is hard and compression is difficult.
　針付き接続部材３の剥離性は、下記の基準で評価した。
Ａ：中空針２と弾性鞘体４が容易に剥離する。
Ｂ：中空針２と弾性鞘体４の剥離は比較的容易であるが、Ａに比べて、装着時のエネルギーが必要となる。
Ｃ：中空針２と弾性鞘体４は剥離するが、Ｂに比べて、装着時のエネルギーがさらに必要である。
Ｄ：剥離不能である。 The peelability of the connecting member 3 with a needle was evaluated according to the following criteria.
A: The hollow needle 2 and the elastic sheath body 4 easily peel off.
B: Separation of the hollow needle 2 and the elastic sheath body 4 is relatively easy, but the energy at the time of wearing is required as compared with A.
C: The hollow needle 2 and the elastic sheath body 4 are peeled off, but more energy is required for mounting than B.
D: Unpeelable.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
　針付き接続部材１を二色成形法又はインサート成形法により製造する場合、部材本体３の中空針２の外面に溶融状態の弾性樹脂を供給し、弾性鞘体４を成形することによって、中空針２の外面が溶融樹脂に接触することで高温となり、少なくとも中空針２の外面は滅菌された状態となる。
　従って、得られた針付き接続部材１は、弾性鞘体４が無傷の状態であれば、少なくとも中空針２の外面について滅菌されていることを保証することができる。
　滅菌とは、所謂、被滅菌物に微生物が生存する確率を１００万分の１個以下（すなわち、被滅菌物１００万個のうち微生物が存在する被滅菌物は１個以下）に減少させることである。本願では、成型した中空針２の外面部に、溶融した高温状態の弾性樹脂を接触させて弾性鞘体４を形成することから、少なくとも中空針２の外面は滅菌され、所謂、無菌状態を達成することができる。つまり少なくとも中空針２の外面は無菌状態が保証できる。
　中空針２の先端部には貫通孔５が設定されており、その貫通孔５を通して薬液と中空針２の外表面が接触することになる。中空針２と弾性鞘体４は、フランジ部１１以外は完全には熔着していない状態であるため、貫通孔５を通じて、熔着していない弾性鞘体部に薬液の滅菌時に発生する湿熱が入り込むことも可能となる。本願の滅菌とは、針付き接続部材１を前記のような状況下にすることで被滅菌物、すなわち少なくとも中空針２の外面に付着する微生物の生存する確率を減少させることである。 When the connecting member 1 with a needle is manufactured by the two-color molding method or the insert molding method, a molten needle is supplied to the outer surface of the hollow needle 2 of the member main body 3 to mold the elastic sheath body 4, thereby forming a hollow needle. When the outer surface of 2 comes into contact with the molten resin, the temperature becomes high, and at least the outer surface of the hollow needle 2 is in a sterilized state.
Therefore, the obtained connecting member 1 with a needle can ensure that at least the outer surface of the hollow needle 2 is sterilized if the elastic sheath 4 is intact.
Sterilization is what is called reducing the probability that microorganisms will survive in an object to be sterilized to 1 / 1,000,000 or less (that is, 1 object or less to be sterilized out of 1 million objects to be sterilized). is there. In the present application, since the elastic sheath body 4 is formed by bringing a molten high-temperature elastic resin into contact with the outer surface portion of the molded hollow needle 2, at least the outer surface of the hollow needle 2 is sterilized to achieve a so-called aseptic condition. can do. That is, at least the outer surface of the hollow needle 2 can be assured.
A through hole 5 is set at the tip of the hollow needle 2, and the chemical solution and the outer surface of the hollow needle 2 come into contact through the through hole 5. Since the hollow needle 2 and the elastic sheath body 4 are not completely welded except for the flange portion 11, wet heat generated during sterilization of the chemical solution through the through-hole 5 to the unsealed elastic sheath body portion. Can also enter. Sterilization of the present application is to reduce the probability of survival of an object to be sterilized, that is, at least microorganisms adhering to the outer surface of the hollow needle 2 by placing the connecting member with a needle 1 in the above-described situation.
　図３は、針付き接続部材１に薬剤入りのバイアル瓶６を装着する際の状態を示す図である。このバイアル瓶６としては、医療分野において通常に使用されている、口部７の天面に穿刺できるように構成された栓体を有するタイプのバイアル瓶を使用することができる。
　このバイアル瓶６を装着する場合、バイアル瓶６の口部７天面の栓体を露出させた状態とし、その口部７を針付き接続部材１のバイアル瓶係合部８に押し込むことで、簡単に装着することができる。 FIG. 3 is a view showing a state when the vial 6 containing a medicine is attached to the connecting member 1 with a needle. As the vial bottle 6, a vial bottle having a stopper that can be punctured on the top surface of the mouth 7, which is normally used in the medical field, can be used.
When the vial 6 is attached, the stopper on the top surface of the mouth portion 7 of the vial 6 is exposed, and the mouth portion 7 is pushed into the vial engaging portion 8 of the connecting member 1 with a needle. Easy to install.
　バイアル瓶装着時、中空針２の針先に、弾性鞘体４を介してバイアル瓶６の栓体が当接して押圧力が加わると、前記栓体が弾性鞘体４を介して中空針２の針先に当たる。さらに、中空針２の針先に加わる押圧力によって、中空針２の先端部外面から弾性鞘体４が剥離し、中空針２の針先が弾性鞘体４を突き破り、さらに栓体を穿刺してバイアル瓶６内部に挿入される。 When the vial body is attached, when the stopper of the vial 6 is brought into contact with the needle tip of the hollow needle 2 via the elastic sheath body 4 and a pressing force is applied thereto, the stopper body is connected to the hollow needle 2 via the elastic sheath body 4. Hit the tip of the needle. Further, due to the pressing force applied to the needle tip of the hollow needle 2, the elastic sheath body 4 is peeled from the outer surface of the distal end portion of the hollow needle 2, the needle tip of the hollow needle 2 breaks through the elastic sheath body 4, and further punctures the plug body. Inserted into the vial 6.
　バイアル瓶６の口部７は、２本以上の突片９を外方に広げながらフランジ部１１側に進行し、それぞれの係合爪１０が口部７を乗り越えて口元縮径部に達した後、それぞれの突片９が弾性的に復元し、それぞれの係合爪１０が口元に係合してバイアル瓶６を保持する。 The mouth portion 7 of the vial 6 advances to the flange portion 11 side while spreading two or more projecting pieces 9 outward, and the respective engaging claws 10 get over the mouth portion 7 to reach the mouth reduced diameter portion. Thereafter, each protrusion 9 is elastically restored, and each engaging claw 10 is engaged with the mouth to hold the vial 6.
　バイアル瓶６が係合爪１０に保持された状態において、中空針２は栓体を突き通してバイアル瓶６内部に到達しており、中空針２の貫通孔５を通してバイアル瓶６の内部と接続管部１２の管内とが連通した状態となる。 In a state where the vial 6 is held by the engaging claw 10, the hollow needle 2 penetrates the stopper and reaches the inside of the vial 6, and is connected to the inside of the vial 6 through the through hole 5 of the hollow needle 2. The pipe portion 12 is in communication with the inside of the pipe.
　本例の針付き接続部材１は、中空針２が立設された部材本体３と、中空針２を覆う弾性鞘体４とを備え、部材本体３の中空針２が立設された一方の面側には、バイアル瓶６の口部７が装着されるように構成されたバイアル瓶係合部８が設けられ、部材本体３の他方の面側には、薬液容器と接続できるように構成された接続管部１２（薬液容器接続部）が設けられ、弾性鞘体４は、少なくとも中空針２の外面を剥離できるように密着した状態で覆っている構成としたものなので、中空針２を覆う弾性鞘体４を形成する際、溶融樹脂を中空針外面に密着させて弾性鞘体４を成形することで、少なくとも弾性鞘体４によって覆われた中空針２の外面を滅菌することができ、この部分の滅菌が保証できることから、薬剤溶解キットとして使用する際に滅菌工程を簡便に行うことができる。 The connecting member 1 with a needle of this example includes a member main body 3 in which a hollow needle 2 is erected and an elastic sheath body 4 that covers the hollow needle 2, and one of the member main body 3 in which the hollow needle 2 is erected. On the surface side, a vial engaging portion 8 configured to be fitted with the mouth portion 7 of the vial 6 is provided, and the other surface side of the member main body 3 is configured to be connected to a drug solution container. Since the connecting tube portion 12 (medical solution container connecting portion) is provided and the elastic sheath body 4 is configured to cover at least the outer surface of the hollow needle 2 so as to be peeled off, the hollow needle 2 is provided. When forming the elastic sheath body 4 to be covered, the outer surface of the hollow needle 2 covered with at least the elastic sheath body 4 can be sterilized by molding the elastic sheath body 4 by bringing the molten resin into close contact with the outer surface of the hollow needle. Because this part can be sterilized, it can be used as a drug dissolution kit. It is possible to perform the sterilization process easily.
　図４は、本発明の針付き接続部材の第２例を示す図である。
　本例の針付き接続部材１７は、前述した第１例の針付き接続部材１とほぼ同様の構成要素を備えて構成されており、同一の構成要素には同一符号を付してある。
　本例の針付き接続部材１７は、薬液容器接続部として、前記接続管部１２に代えて、管状体の外周面にネジ部１６（雄ネジ）が形成された接続ネジ部１５を設けたことを特徴としている。 FIG. 4 is a view showing a second example of the connecting member with a needle of the present invention.
The connecting member 17 with a needle of this example is configured to include substantially the same components as the connecting member 1 with a needle of the first example described above, and the same components are denoted by the same reference numerals.
The connecting member 17 with a needle of this example is provided with a connecting screw part 15 in which a screw part 16 (male thread) is formed on the outer peripheral surface of the tubular body, instead of the connecting pipe part 12, as a chemical container connecting part. It is characterized by.
　この接続ネジ部１５は、管状ネジ部が設けられたプレフィルドシリンジタイプの薬液容器を用いる場合に、接続ネジ部１５を薬液容器の管状ネジ部に螺着することによって、針付き接続部材１７と薬液容器とを着脱できるように接続する。
　接続ネジ部１５を薬液容器の管状ネジ部に螺着するとは、接続ネジ部１５を薬液容器の管状ネジ部にねじ込んで取り着けることを意味する。
　図４に図示した例では、接続ネジ部１５の外周面に雄ネジとなるネジ部１６が形成された構成であるが、管状ネジ部に雄ネジが形成されているタイプの薬液容器に適合させる場合には、前記接続ネジ部１５として管状体の内周面に雌ネジが形成された接続ネジ部を備えた構成としてもよい。 When the prefilled syringe type chemical solution container provided with the tubular screw portion is used, the connection screw portion 15 is formed by screwing the connection screw portion 15 onto the tubular screw portion of the chemical solution container, thereby connecting the connection member 17 with the needle and the chemical solution. Connect the container so that it can be removed.
The screwing of the connection screw portion 15 to the tubular screw portion of the chemical liquid container means that the connection screw portion 15 is screwed into the tubular screw portion of the chemical liquid container.
In the example illustrated in FIG. 4, the screw portion 16 that is a male screw is formed on the outer peripheral surface of the connection screw portion 15, but it is adapted to a chemical solution container in which a male screw is formed on the tubular screw portion. In this case, the connecting screw portion 15 may be provided with a connecting screw portion in which a female screw is formed on the inner peripheral surface of the tubular body.
　本例の針付き接続部材１７は、前述した第１例の針付き接続部材１とほぼ同様の効果を得ることができ、さらに薬液容器の管状ネジ部と着脱できるように接続できる接続ネジ部１５を有する構成としたことによって、薬液容器の交換や付け替えが可能となるなど、薬剤溶解キットの利用形態を広げることができる。 The connecting member 17 with the needle of this example can obtain substantially the same effect as the connecting member 1 with the needle of the first example described above, and can further be connected to the tubular screw portion of the chemical container so as to be detachable. With this configuration, it is possible to expand the usage forms of the drug dissolution kit, such as enabling replacement and replacement of the chemical solution container.
（薬剤溶解キット）
　図５は、本発明の薬剤溶解キットの第１例を示す図である。
　本例の薬剤溶解キット２０は、前述した針付き接続部材１と、薬液容器２２とからなり、針付き接続部材１に設けられた接続管部１２と薬液容器２０の管状接続部２１とが接続された構成になっている。 (Drug dissolution kit)
FIG. 5 is a diagram showing a first example of the drug dissolution kit of the present invention.
The drug dissolution kit 20 of the present example includes the above-described connecting member 1 with a needle and a chemical solution container 22, and the connecting pipe portion 12 provided on the connecting member 1 with a needle and the tubular connecting portion 21 of the chemical solution container 20 are connected to each other. It has been configured.
　前記薬液容器２２は、合成樹脂製の容器本体に薬液２３が密封充填されてなり、前記容器本体の一端側には、前記管状接続部２１が設けられ、この管状接続部２１の先端に針付き接続部材１が溶着接合されている。また容器本体の他端側には、収容している薬液２３を流出させるための薬液流出口２５が設けられ、前記薬液流出口２５の開口には栓体２６が設けられている。 The chemical solution container 22 is formed by sealing and filling a chemical resin container body 23 with a chemical solution 23. The tubular connection portion 21 is provided at one end of the container body, and a needle is attached to the distal end of the tubular connection portion 21. The connecting member 1 is welded and joined. The other end of the container main body is provided with a chemical liquid outlet 25 for allowing the stored chemical liquid 23 to flow out, and a stopper 26 is provided at the opening of the chemical liquid outlet 25.
　針付き接続部材１の接続管部１２と薬液容器２０の管状接続部２１とは、接合部２４で溶着接合されている。針付き接続部材１の接続管部１２と薬液容器２０の管状接続部２１とが同種の合成樹脂、例えばポリプロピレン等で構成されている場合には、接続管部１２と管状接続部２１の端部同士を加熱溶融し、簡単に溶着することができる。接続管部１２と管状接続部２１とを接続するための方法は、溶着接合に限定されるものではなく、ジョイント部材などの適当な接続部材を用いた接続方法でもよい。 The connecting pipe portion 12 of the connecting member with needle 1 and the tubular connecting portion 21 of the chemical solution container 20 are welded and joined at the joint portion 24. When the connecting pipe portion 12 of the connecting member 1 with the needle and the tubular connecting portion 21 of the chemical solution container 20 are made of the same kind of synthetic resin, for example, polypropylene, the end portions of the connecting pipe portion 12 and the tubular connecting portion 21 are used. They can be melted together and welded easily. The method for connecting the connecting pipe portion 12 and the tubular connecting portion 21 is not limited to welding joining, and may be a connecting method using an appropriate connecting member such as a joint member.
　図６は、本例の薬剤溶解キット２０の製造工程を示す図である。
　この薬剤溶解キット２０を製造するには、針付き接続部材１と薬液容器２２とを別々に成形して用意する（図６（ａ））。この薬液容器２２は、薬液２３が入っていない空の状態であり、薬液流出口２５は開口している。
　次に、図６（ｂ）に示すように、薬液容器２２の管状接続部２１と針付き接続部材１の接続管部１２とのそれぞれの端部を加熱し、突き合わせることによって溶着接合する。 FIG. 6 is a diagram showing a manufacturing process of the drug dissolution kit 20 of this example.
In order to manufacture this medicine dissolution kit 20, the connecting member 1 with a needle and the chemical solution container 22 are separately formed and prepared (FIG. 6 (a)). The chemical solution container 22 is empty without the chemical solution 23, and the chemical solution outlet 25 is open.
Next, as shown in FIG.6 (b), each edge part of the tubular connection part 21 of the chemical | medical solution container 22 and the connection pipe part 12 of the connection member 1 with a needle | hook is heated, and it welds and joins by abutting.
　次に、薬液容器２２の薬液流出口２５から薬液２３を容器内に注入し、その後、図６（ｃ）に示すように、薬液流出口２５の開口に封止体２６を取り付けて、薬液容器２２を密封する。これによって薬剤溶解キット２０が作製される。薬剤溶解キット２０の製造工程は、図６に示す製造工程のみに限定されるものではなく、薬液容器２２に封止体２６を取り付け、管状接続部２１から薬液充填して針付き接続部材１を接続する工程でも良い。
　次に、この薬剤溶解キット２０に滅菌処理を施す（図６（ｄ））。高圧蒸気滅菌等の滅菌処理によって、薬液容器２２に収容された薬液は滅菌される。この時、薬液容器２２内部と中空針２の貫通孔５とは連通しているので、薬液２３の滅菌と同時に中空針２の内部まで滅菌される。 Next, the chemical liquid 23 is injected into the container from the chemical liquid outlet 25 of the chemical liquid container 22, and then a sealing body 26 is attached to the opening of the chemical liquid outlet 25 as shown in FIG. 22 is sealed. Thereby, the medicine dissolution kit 20 is produced. The manufacturing process of the medicine dissolution kit 20 is not limited to the manufacturing process shown in FIG. 6. The sealing member 26 is attached to the chemical liquid container 22, the chemical liquid is filled from the tubular connection part 21, and the connecting member 1 with a needle is attached. A process of connecting may be used.
Next, the drug dissolution kit 20 is sterilized (FIG. 6D). The chemical solution stored in the chemical solution container 22 is sterilized by a sterilization process such as high-pressure steam sterilization. At this time, since the inside of the chemical solution container 22 and the through-hole 5 of the hollow needle 2 communicate with each other, the inside of the hollow needle 2 is sterilized simultaneously with the sterilization of the chemical solution 23.
　図７は、薬剤溶解キット２０を医療施設等で使用する方法を示す図である。
　この薬剤溶解キット２０は、図７（ａ）に示す針付き接続部材１の中空針２側に、所望の薬剤１８が封入されたバイアル瓶６の口部７を押し込むことで、バイアル瓶６内部と薬液容器２２内部とが連通され、薬剤１８と薬液２３とを混合できるようになる。
　図７（ｂ）に示すように、バイアル瓶６の口部７を押し込んだ際、中空針２の針先に、弾性鞘体４を介してバイアル瓶６の栓体が当接して押圧力が加わると、前記栓体が弾性鞘体４を介して中空針２の針先に当たる。さらに、中空針２の針先に加わる押圧力によって、中空針２の先端部外面から弾性鞘体４が剥離し、中空針２の針先が弾性鞘体４を突き破り、さらに栓体を穿刺して中空針２がバイアル瓶６内部に挿入される。 FIG. 7 is a diagram showing a method of using the drug dissolution kit 20 in a medical facility or the like.
This drug dissolution kit 20 is formed by pushing the mouth 7 of the vial 6 in which the desired drug 18 is sealed into the hollow needle 2 side of the connecting member 1 with a needle shown in FIG. And the inside of the chemical liquid container 22 communicate with each other, so that the medicine 18 and the chemical liquid 23 can be mixed.
As shown in FIG. 7B, when the mouth portion 7 of the vial 6 is pushed in, the stopper of the vial 6 comes into contact with the tip of the hollow needle 2 via the elastic sheath body 4 so that the pressing force is applied. When applied, the stopper hits the tip of the hollow needle 2 through the elastic sheath 4. Further, due to the pressing force applied to the needle tip of the hollow needle 2, the elastic sheath body 4 is peeled from the outer surface of the distal end portion of the hollow needle 2, the needle tip of the hollow needle 2 breaks through the elastic sheath body 4, and further punctures the plug body. Then, the hollow needle 2 is inserted into the vial 6.
　中空針２がバイアル瓶６内部に侵入すると同時に、貫通孔５がバイアル瓶６内部に露出して、バイアル瓶６内部と薬液容器２２内部とが、中空針２の貫通孔５を通して連通する。この状態で薬剤溶解キット２０を上に向けることで、薬液２３がバイアル瓶６内部に注入される。バイアル瓶６内部に注入された薬液によって、バイアル瓶６内に収容されていた薬剤１８が溶解（或いは分散）し、その後、薬剤溶解キット２０を下に向けることで、バイアル瓶６内の薬剤を含んだ薬液が、貫通孔５を通して薬液容器２２内に移行する。
　薬剤１８を含む薬液２３は、薬液容器２２の栓体２６を穿刺して連結される導液ライン等により、患者の体内等に供給される。 At the same time as the hollow needle 2 enters the inside of the vial 6, the through hole 5 is exposed inside the vial 6, and the inside of the vial 6 and the inside of the drug solution container 22 communicate with each other through the through hole 5 of the hollow needle 2. In this state, the drug solution kit 20 is directed upward to inject the drug solution 23 into the vial 6. The drug 18 contained in the vial 6 is dissolved (or dispersed) by the drug solution injected into the vial 6, and then the drug dissolution kit 20 is directed downward to remove the drug in the vial 6. The contained chemical liquid moves into the chemical liquid container 22 through the through hole 5.
The drug solution 23 containing the drug 18 is supplied to the patient's body or the like through a liquid guide line or the like that is pierced through the stopper 26 of the drug solution container 22.
　この薬剤溶解キット２０は、薬剤容器２２に針付き接続部材１を接続した構成なので、少なくとも弾性鞘体４によって覆われた中空針２の外面については滅菌を保証することができることから、薬剤溶解キット２０として使用する際に滅菌工程を簡便に行うことができる。 Since the drug dissolution kit 20 has a configuration in which the connecting member 1 with the needle is connected to the drug container 22, at least the outer surface of the hollow needle 2 covered by the elastic sheath body 4 can be guaranteed sterilization. When using as 20, a sterilization process can be performed simply.
　図８は、前述した薬剤溶解キット２０を吊り下げて支持できるように構成された吊り具２７を備えた例を示す図である。
　本例では、合成樹脂製のバンド状の吊り具２７を用い、前記吊り具２７の両端を針付き接続部材１の部材本体３外面に取り付けた構成になっている。吊り具２７の接合位置は本例示に限定されず、薬液容器２２側に接合してもよいし、バンド状以外の各種の形状の吊り具を用いることもできる。 FIG. 8 is a view showing an example provided with a lifting tool 27 configured to suspend and support the drug dissolution kit 20 described above.
In this example, a synthetic resin band-shaped lifting tool 27 is used, and both ends of the lifting tool 27 are attached to the outer surface of the member body 3 of the connecting member 1 with a needle. The joining position of the hanger 27 is not limited to this example, and the hanger 27 may be joined to the chemical solution container 22 side, or hanger having various shapes other than the band shape may be used.
　図９は、吊り具２７の取り付け方法の第１例を示す図である。
　本例では、針付き接続部材１の部材本体３外面に、吊り具２７の端部を重ね合わせ、その部分にヒータ２８を接近させて加熱し、吊り具２７の端部を部材本体３外面に溶着している。 FIG. 9 is a diagram illustrating a first example of a method for attaching the hanger 27.
In this example, the end of the hanger 27 is superposed on the outer surface of the member main body 3 of the connecting member 1 with the needle, the heater 28 is brought close to that portion and heated, and the end of the hanger 27 is placed on the outer surface of the member main body 3. Welding.
　図１０は、吊り具２７の取り付け方法の第２例を示す図である。
　本例では、吊り具２７の両端部に、取付用の穴２７ａを穿設すると共に、部材本体３外面に、前記穴２７ａに挿入できるように構成された頭部を持つキノコ状の突起２９を設けておく。そして、吊り具２７の穴２７ａに部材本体３外面の突起２９を挿入することで、吊り具２７の両端を針付き接続部材１の部材本体３外面に取り付けることができる。 FIG. 10 is a diagram illustrating a second example of a method for attaching the hanger 27.
In this example, attachment holes 27a are formed at both ends of the hanger 27, and mushroom-like protrusions 29 having heads configured to be inserted into the holes 27a are formed on the outer surface of the member body 3. Keep it. Then, by inserting the protrusions 29 on the outer surface of the member main body 3 into the holes 27a of the hanger 27, both ends of the hanger 27 can be attached to the outer surface of the member main body 3 of the connecting member 1 with the needle.
　図１１は、本発明の薬剤溶解キットの第２例の製造工程を示す正面断面図である。
　本例の薬剤溶解キット３５は、図１１（ｅ）に示すように、接続ネジ部１５が設けられた図４に示す構成の針付き接続部材１７と、薬液３２がゴム封止材３３によって密封されているシリンジ３０（薬液容器）と、シリンジ３０内に先端側が挿入されたピストン部材３４とを備えて構成されている。シリンジ３０の先端部には、内周面にネジ部３１ａ（雌ネジ）が設けられた管状ネジ部３１が設けられ、この管状ネジ部３１には、針付き接続部材１７の接続ネジ部１５が挿入及び螺着され、針付き接続部材１７とシリンジ３０とが接続されている。管状ネジ部３１と接続ネジ部１５との接続部分には、液漏れ防止用のｏ－リングを介在させてもよい。
　管状ネジ部３１に接続ネジ部１５が螺着されるとは、接続ネジ部１５を管状ネジ部３１にねじ込んで取り着けることを意味する。 FIG. 11 is a front sectional view showing a manufacturing process of the second example of the drug dissolution kit of the present invention.
In the drug dissolution kit 35 of this example, as shown in FIG. 11 (e), the connecting member 17 with the needle shown in FIG. 4 provided with the connecting screw portion 15 and the drug solution 32 are sealed with a rubber sealing material 33. The syringe 30 (chemical solution container) and the piston member 34 having the distal end inserted into the syringe 30 are configured. The distal end portion of the syringe 30 is provided with a tubular screw portion 31 provided with a screw portion 31a (female screw) on the inner peripheral surface, and the connection screw portion 15 of the connecting member 17 with the needle is provided on the tubular screw portion 31. Inserted and screwed, the connecting member 17 with the needle and the syringe 30 are connected. An o-ring for preventing liquid leakage may be interposed at the connection portion between the tubular screw portion 31 and the connection screw portion 15.
The connection screw portion 15 being screwed to the tubular screw portion 31 means that the connection screw portion 15 is screwed into the tubular screw portion 31 and attached.
　この薬剤溶解キット３５を製造するには、別々に成形したシリンジ３０と針付き接続部材１７とを用意し、図１１（ａ）に示すように、シリンジ３０の管状ネジ部３１に針付き接続部材１７の接続ネジ部１５を嵌め込み、図中矢印で示す装着方向に回して螺着する。
　図１１（ｂ）に示すように、針付き接続部材１７の接続ネジ部１５とシリンジ３０の管状ネジ部３１との螺着が完了し、針付き接続部材１７とシリンジ３０とを接続した後、図１１（ｃ）に示すように、シリンジ３０内に薬液３２を注入する。
　次に、図１１（ｄ）に示すように、シリンジ３０内にゴム封止材３３を打栓してシリンジ３０内の薬液３２を密封し、さらにキット全体を加熱滅菌する。
　次に、図１１（ｅ）に示すように、シリンジ３０の後端側から、ゴム封止材３３を移動させるためのピストン部材３４を装着し、薬剤溶解キット３５を得る。 In order to manufacture the drug dissolution kit 35, a separately prepared syringe 30 and a connecting member 17 with a needle are prepared, and a connecting member with a needle is attached to the tubular screw portion 31 of the syringe 30 as shown in FIG. 17 connecting screw portions 15 are fitted and screwed by turning in a mounting direction indicated by an arrow in the figure.
As shown in FIG. 11 (b), after the screwing of the connecting screw portion 15 of the connecting member 17 with the needle and the tubular screw portion 31 of the syringe 30 is completed and the connecting member 17 with the needle and the syringe 30 are connected, As shown in FIG. 11 (c), a chemical solution 32 is injected into the syringe 30.
Next, as shown in FIG. 11 (d), a rubber sealing material 33 is plugged into the syringe 30 to seal the chemical solution 32 in the syringe 30, and the entire kit is further heat sterilized.
Next, as shown in FIG. 11 (e), a piston member 34 for moving the rubber sealing material 33 is attached from the rear end side of the syringe 30 to obtain a drug dissolution kit 35.
　図１２は、本例の薬剤溶解キット３５の使用方法を説明する図である。
　この薬剤溶解キット３５の薬液３２に、バイアル瓶６内の別の薬剤を混合するには、図１２（ａ）に示すように、バイアル瓶６の口部７を薬剤溶解キット３５の針付き接続部材１７のバイアル瓶係合部８に押し込む。この押し込み操作によって、中空針２が弾性鞘体４とバイアル瓶６の天面に設けられた栓体とを突き破ってバイアル瓶６内に侵入する。その後、シリンジ３０のピストン部材３４を押し込んで薬液３２の一部又は全部をバイアル瓶６内に注入し、振り混ぜることによってバイアル瓶６内の薬剤を溶解させる。次に、シリンジ３０のピストン部材３４を引き、バイアル瓶３０内の薬剤を含む薬液３２をシリンジ３０内に吸入する。 FIG. 12 is a diagram illustrating a method of using the drug dissolution kit 35 of this example.
In order to mix another drug in the vial 6 with the drug solution 32 of the drug dissolution kit 35, the mouth portion 7 of the vial 6 is connected with a needle of the drug dissolution kit 35 as shown in FIG. The member 17 is pushed into the vial engaging portion 8. By this pushing operation, the hollow needle 2 breaks through the elastic sheath body 4 and the stopper provided on the top surface of the vial 6 and enters the vial 6. Thereafter, the piston member 34 of the syringe 30 is pushed in to inject a part or all of the drug solution 32 into the vial 6 and shaken to dissolve the drug in the vial 6. Next, the piston member 34 of the syringe 30 is pulled, and the drug solution 32 containing the drug in the vial 30 is sucked into the syringe 30.
　次に、図１２（ｂ）に示すように、針付き接続部材１７のバイアル瓶係合部８からバイアル瓶６を取り外す。
　次に、針付き接続部材１７をシリンジ３０からの離脱方向に回し、針付き接続部材１７をシリンジ３０から取り外す（図１２（ｃ））。
　次に、図１２（ｄ）に示すように、シリンジ３０の管状ネジ部３１にルアーロック式のライン３６と接続し、シリンジ３０内の薬剤を含む薬液を混注する。
　ルアーロック式とは管状ネジ部３１に合わせて螺合形状に成形された螺着固定可能な方式で取り付ける方法を言う。 Next, as shown in FIG.12 (b), the vial 6 is removed from the vial engaging part 8 of the connection member 17 with a needle | hook.
Next, the connecting member 17 with the needle is rotated in the direction of detachment from the syringe 30 and the connecting member 17 with the needle is removed from the syringe 30 (FIG. 12C).
Next, as shown in FIG. 12 (d), the luer lock type line 36 is connected to the tubular threaded portion 31 of the syringe 30, and a chemical solution containing the drug in the syringe 30 is mixedly injected.
The luer lock type refers to a method of attaching in a screwed and fixed manner formed into a screwed shape in accordance with the tubular screw portion 31.
　この薬剤溶解キット３５は、シリンジ３０に針付き接続部材１７を接続した構成なので、少なくとも弾性鞘体４によって覆われた中空針２の外面については滅菌を保証することができることから、滅菌工程を簡便に行うことができる。
　また、この薬剤溶解キット３５は、薬液容器であるシリンジ３０と針付き接続部材１７とを着脱できるように接続する構成なので、薬剤を薬液に溶解後にシリンジ３０から針付き接続部材１７を取り外すことによって薬剤溶解キットの利用形態を広げることができる。 Since this medicine dissolution kit 35 has a configuration in which the connecting member 17 with a needle is connected to the syringe 30, at least the outer surface of the hollow needle 2 covered with the elastic sheath body 4 can be assured of sterilization. Can be done.
In addition, since the drug dissolution kit 35 is configured to connect the syringe 30 that is a chemical solution container and the connecting member 17 with the needle so as to be detachable, the connecting member 17 with the needle is removed from the syringe 30 after dissolving the drug in the chemical solution. The use form of the drug dissolution kit can be expanded.
　本発明のまた別の側面の針付き接続部材は、
　中空針が立設された部材本体と、前記中空針を覆う弾性鞘体とを備え、
　前記部材本体の中空針が立設された側と反対の面側には、薬液容器と接続できるように構成された薬液容器接続部が設けられた針付き接続部材であって、
　前記弾性鞘体は、少なくとも前記中空針の外面を剥離できるように密着した状態で覆い、
　前記中空針の外面に前記弾性鞘体を二色成形法又はインサート成形法によって設け、
　少なくとも前記弾性鞘体によって覆われた中空針の外面が、滅菌保証されており、
　前記弾性鞘体の先端に平面部が形成され、
　前記部材本体は、前記中空針の基部周縁から広がったフランジ部を有し、かつ前記弾性鞘体の基部が前記フランジ部の面に沿って広がるフランジ状基部を有し、
　前記薬液容器接続部が、接続する薬液容器に設けられた管状接続部と接続できるように構成された接続管部を有し、
　前記部材本体の中空針が立設された面側には、バイアル瓶の口部が装着されるように構成されたバイアル瓶係合部が設けられ、
　前記薬液容器接続部が、接続する薬液容器に設けられた管状ネジ部に螺着螺着できるように構成された接続ネジ部を有し、
　前記部材本体と前記中空針はポリプロピレンからなり、
　前記弾性鞘体はスチレン－エチレン－ブチレン－スチレンブロック共重合体（ＳＥＢＳ）からなることが好ましい。 The connecting member with a needle according to still another aspect of the present invention is:
A member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle,
On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
The elastic sheath body covers at least the outer surface of the hollow needle so that it can be peeled off,
The elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method or an insert molding method,
At least the outer surface of the hollow needle covered by the elastic sheath body is guaranteed to be sterilized,
A flat portion is formed at the tip of the elastic sheath body,
The member main body has a flange portion that spreads from the base periphery of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion,
The chemical liquid container connecting portion has a connecting pipe portion configured to be connected to a tubular connecting portion provided in a chemical liquid container to be connected,
On the surface side where the hollow needle of the member body is erected, a vial engaging portion configured to be attached to the mouth portion of the vial is provided,
The chemical liquid container connecting portion has a connection screw portion configured to be screwed into a tubular screw portion provided in the chemical liquid container to be connected,
The member body and the hollow needle are made of polypropylene,
The elastic sheath is preferably made of styrene-ethylene-butylene-styrene block copolymer (SEBS).
　本発明のまた別の側面の薬剤溶解キットは、
　中空針が立設された部材本体と、前記中空針を覆う弾性鞘体とを備え、
　前記部材本体の中空針が立設された側と反対の面側には、薬液容器と接続できるように構成された薬液容器接続部が設けられた針付き接続部材であって、
　前記弾性鞘体は、少なくとも前記中空針の外面を剥離できるように密着した状態で覆い、
　前記中空針の外面に前記弾性鞘体を二色成形法又はインサート成形法によって設け、
　少なくとも前記弾性鞘体によって覆われた中空針の外面が、滅菌保証されており、
　前記弾性鞘体の先端に平面部が形成され、
　前記部材本体は、前記中空針の基部周縁から広がったフランジ部を有し、かつ前記弾性鞘体の基部が前記フランジ部の面に沿って広がるフランジ状基部を有し、
　前記薬液容器接続部が、接続する薬液容器に設けられた管状接続部と接続できるように構成された接続管部を有し、
　前記部材本体の中空針が立設された面側には、バイアル瓶の口部が装着されるように構成されたバイアル瓶係合部が設けられ、
　前記部材本体と前記中空針はポリプロピレンからなり、
　前記弾性鞘体はスチレン－エチレン－ブチレン－スチレンブロック共重合体（ＳＥＢＳ）からなる、針付き接続部材と、
　管状接続部が設けられた薬液容器とを備え、
　針付き接続部材に設けられた接続管部と、薬液容器の管状接続部とが薬液が流通できるように接続されており、
　前記薬液容器は、収容している薬液を流出させるための薬液流出口が設けられ、
　前記針付き接続部材又は前記薬液容器に、薬剤溶解キットを吊下げ支持できるように構成された吊り具が設けられていることが好ましい。 The drug dissolution kit according to another aspect of the present invention is as follows.
A member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle,
On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
The elastic sheath body covers at least the outer surface of the hollow needle so that it can be peeled off,
The elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method or an insert molding method,
At least the outer surface of the hollow needle covered by the elastic sheath body is guaranteed to be sterilized,
A flat portion is formed at the tip of the elastic sheath body,
The member main body has a flange portion that spreads from the base periphery of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion,
The chemical liquid container connecting portion has a connecting pipe portion configured to be connected to a tubular connecting portion provided in a chemical liquid container to be connected,
On the surface side where the hollow needle of the member body is erected, a vial engaging portion configured to be attached to the mouth portion of the vial is provided,
The member body and the hollow needle are made of polypropylene,
The elastic sheath body is made of a styrene-ethylene-butylene-styrene block copolymer (SEBS), a connecting member with a needle,
A chemical container provided with a tubular connection part,
The connecting pipe part provided in the connecting member with the needle and the tubular connecting part of the chemical liquid container are connected so that the chemical liquid can circulate,
The chemical solution container is provided with a chemical solution outlet for discharging the contained chemical solution,
It is preferable that a hanging tool configured to suspend and support the drug dissolution kit is provided on the connecting member with a needle or the chemical solution container.
　本発明のまた別の側面の薬剤溶解キットは、
　中空針が立設された部材本体と、前記中空針を覆う弾性鞘体とを備え、
　前記部材本体の中空針が立設された側と反対の面側には、薬液容器と接続できるように構成された薬液容器接続部が設けられた針付き接続部材であって、
　前記弾性鞘体は、少なくとも前記中空針の外面を剥離できるように密着した状態で覆い、
　前記中空針の外面に前記弾性鞘体を二色成形法又はインサート成形法によって設け、
　少なくとも前記弾性鞘体によって覆われた中空針の外面が、滅菌保証されており、
　前記弾性鞘体の先端に平面部が形成され、
　前記部材本体は、前記中空針の基部周縁から広がったフランジ部を有し、かつ前記弾性鞘体の基部が前記フランジ部の面に沿って広がるフランジ状基部を有し、
　前記薬液容器接続部が、接続する薬液容器に設けられた管状接続部と接続できるように構成された接続管部を有し、
　前記部材本体の中空針が立設された面側には、バイアル瓶の口部が装着されるように構成されたバイアル瓶係合部が設けられ、
　前記薬液容器接続部が、接続する薬液容器に設けられた管状ネジ部に螺着できるように構成された接続ネジ部を有し、
　前記部材本体と前記中空針はポリプロピレンからなり、
　前記弾性鞘体はスチレン－エチレン－ブチレン－スチレンブロック共重合体（ＳＥＢＳ）からなる、針付き接続部材と、
　管状ネジ部が設けられた薬液容器とを備え、
　針付き接続部材に設けられた接続ネジ部と、薬液容器の管状ネジ部とが薬液が流通できるように螺着により接続され、
　前記薬液容器は、収容している薬液を流出させるための薬液流出口が設けられ、
　前記針付き接続部材又は前記薬液容器に、薬剤溶解キットを吊下げ支持できるように構成された吊り具が設けられていることが好ましい。 The drug dissolution kit according to another aspect of the present invention is as follows.
A member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle,
On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
The elastic sheath body covers at least the outer surface of the hollow needle so that it can be peeled off,
The elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method or an insert molding method,
At least the outer surface of the hollow needle covered by the elastic sheath body is guaranteed to be sterilized,
A flat portion is formed at the tip of the elastic sheath body,
The member main body has a flange portion that spreads from the base periphery of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion,
The chemical liquid container connecting portion has a connecting pipe portion configured to be connected to a tubular connecting portion provided in a chemical liquid container to be connected,
On the surface side where the hollow needle of the member body is erected, a vial engaging portion configured to be attached to the mouth portion of the vial is provided,
The chemical solution container connection portion has a connection screw portion configured to be screwed to a tubular screw portion provided in the chemical solution container to be connected,
The member body and the hollow needle are made of polypropylene,
The elastic sheath body is made of a styrene-ethylene-butylene-styrene block copolymer (SEBS), a connecting member with a needle,
A chemical container provided with a tubular screw part,
The connection screw part provided in the connecting member with the needle and the tubular screw part of the chemical liquid container are connected by screwing so that the chemical liquid can circulate,
The chemical solution container is provided with a chemical solution outlet for discharging the contained chemical solution,
It is preferable that a hanging tool configured to suspend and support the drug dissolution kit is provided on the connecting member with a needle or the chemical solution container.
　本発明のまた別の側面の薬剤溶解キットは、
　中空針が立設された部材本体と、前記中空針を覆う弾性鞘体とを備え、
　前記部材本体の中空針が立設された側と反対の面側には、薬液容器と接続できるように構成された薬液容器接続部が設けられた針付き接続部材であって、
　前記弾性鞘体は、少なくとも前記中空針の外面を剥離できるように密着した状態で覆い、
　前記中空針の外面に前記弾性鞘体を二色成形法又はインサート成形法によって設け、
　少なくとも前記弾性鞘体によって覆われた中空針の外面が、滅菌保証されており、
　前記弾性鞘体の先端に平面部が形成され、
　前記部材本体は、前記中空針の基部周縁から広がったフランジ部を有し、かつ前記弾性鞘体の基部が前記フランジ部の面に沿って広がるフランジ状基部を有し、
　前記薬液容器接続部が、接続する薬液容器に設けられた管状接続部と接続できるように構成された接続管部を有し、
　前記部材本体の中空針が立設された面側には、バイアル瓶の口部が装着されるように構成されたバイアル瓶係合部が設けられ、
　前記薬液容器接続部が、接続する薬液容器に設けられた管状ネジ部に螺着できるように構成された接続ネジ部を有し、
　前記部材本体と前記中空針はポリプロピレンからなり、
　前記弾性鞘体はスチレン－エチレン－ブチレン－スチレンブロック共重合体（ＳＥＢＳ）からなる、針付き接続部材と、
　管状ネジ部が設けられた薬液容器とを備え、
　前記針付き接続部材に設けられた前記接続ネジ部と前記薬液容器の前記管状ネジ部とが着脱できるように接続されており、この前記接続ネジ部と前記管状ネジ部が共にルアーロック式であることが好ましい。 The drug dissolution kit according to another aspect of the present invention is as follows.
A member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle,
On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
The elastic sheath body covers at least the outer surface of the hollow needle so that it can be peeled off,
The elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method or an insert molding method,
At least the outer surface of the hollow needle covered by the elastic sheath body is guaranteed to be sterilized,
A flat portion is formed at the tip of the elastic sheath body,
The member main body has a flange portion that spreads from the base periphery of the hollow needle, and the base portion of the elastic sheath body has a flange-like base portion that extends along the surface of the flange portion,
The chemical liquid container connecting portion has a connecting pipe portion configured to be connected to a tubular connecting portion provided in a chemical liquid container to be connected,
On the surface side where the hollow needle of the member main body is erected, a vial engaging portion configured to be fitted with a mouth portion of a vial is provided,
The chemical solution container connection portion has a connection screw portion configured to be screwed to a tubular screw portion provided in the chemical solution container to be connected,
The member body and the hollow needle are made of polypropylene,
The elastic sheath body is made of a styrene-ethylene-butylene-styrene block copolymer (SEBS), a connecting member with a needle,
A chemical container provided with a tubular screw part,
The connection screw portion provided in the connection member with the needle and the tubular screw portion of the chemical solution container are connected so as to be detachable, and both the connection screw portion and the tubular screw portion are of a luer lock type. It is preferable.
　本発明は、薬液容器に別のバイアル瓶を接続できるように構成された針付き接続部材、前記針付き接続部材と薬液容器とを接続した薬剤溶解キットに関する。 The present invention relates to a connecting member with a needle configured so that another vial can be connected to the drug solution container, and a drug dissolving kit in which the connecting member with a needle and the drug solution container are connected.
　１…針付き接続部材、２…中空針、３…部材本体、４…弾性鞘体、５…貫通孔、６…バイアル瓶、７…口部、８…バイアル瓶係合部、９…突片、１０…係合爪、１１…フランジ部、１２…接続管部（薬液容器接続部）、１３…フランジ状基部、１４…平面部、１５…接続ネジ部（薬液容器接続部）、１６…ネジ部、１７…針付き接続部材、１８…薬剤、２０…薬剤溶解キット、２１…管状接続部、２２…薬液容器、２３…薬液、２４…接合部、２５…薬液流出口、２６…栓体、２７…吊り具、２７ａ…穴、２８…ヒータ、２９…突起、３０…シリンジ、３１…管状ネジ部、３１ａ…ネジ部、３２…薬液、３３…ゴム封止材、３４…ピストン部材、３５…薬剤溶解キット、３６…ルアーロック式のライン。 DESCRIPTION OF SYMBOLS 1 ... Connection member with a needle, 2 ... Hollow needle, 3 ... Member main body, 4 ... Elastic sheath body, 5 ... Through-hole, 6 ... Vial bottle, 7 ... Mouth part, 8 ... Vial bottle engaging part, 9 ... Projection piece DESCRIPTION OF SYMBOLS 10 ... Engagement nail | claw, 11 ... Flange part, 12 ... Connection pipe part (chemical solution container connection part), 13 ... Flange-like base part, 14 ... Plane part, 15 ... Connection screw part (chemical solution container connection part), 16 ... Screw 17: Connecting member with needle, 18 ... Drug, 20 ... Drug dissolution kit, 21 ... Tubular connecting part, 22 ... Chemical solution container, 23 ... Chemical solution, 24 ... Joint, 25 ... Chemical solution outlet, 26 ... Plug body, 27 ... Suspension tool, 27a ... Hole, 28 ... Heater, 29 ... Protrusion, 30 ... Syringe, 31 ... Tubular screw part, 31a ... Screw part, 32 ... Chemical solution, 33 ... Rubber sealant, 34 ... Piston member, 35 ... Drug dissolution kit, 36 ... Luer lock type line.

Claims (14)

  1. 　中空針が立設された部材本体と、前記中空針を覆う弾性鞘体とを備え、
    　前記部材本体の中空針が立設された側と反対の面側には、薬液容器と接続できるように構成された薬液容器接続部が設けられた針付き接続部材であって、
    　前記弾性鞘体は、少なくとも前記中空針の外面を剥離できるように密着した状態で覆っている、針付き接続部材。     A member main body in which a hollow needle is erected, and an elastic sheath covering the hollow needle,
    On the side opposite to the side where the hollow needle of the member body is erected, there is a connecting member with a needle provided with a chemical solution container connecting portion configured to be connected to a chemical solution container,
    The elastic sheath body is a connecting member with a needle that covers at least the outer surface of the hollow needle so as to be peeled off.
  2. 　前記中空針の外面に前記弾性鞘体を二色成形法によって設けた、請求項１に記載の針付き接続部材。 The connecting member with a needle according to claim 1, wherein the elastic sheath body is provided on the outer surface of the hollow needle by a two-color molding method.
  3. 　前記中空針の外面に前記弾性鞘体をインサート成形法によって設けた、請求項１に記載の針付き接続部材。 The connecting member with a needle according to claim 1, wherein the elastic sheath body is provided on an outer surface of the hollow needle by an insert molding method.
  4. 　少なくとも前記弾性鞘体によって覆われた中空針の外面が、滅菌保証されている、請求項１～３のいずれか１項に記載の針付き接続部材。 The connecting member with a needle according to any one of claims 1 to 3, wherein at least an outer surface of the hollow needle covered with the elastic sheath body is guaranteed to be sterilized.
  5. 　前記弾性鞘体の先端に平面部が形成されている、請求項１～４のいずれか１項に記載の針付き接続部材。 The connecting member with a needle according to any one of claims 1 to 4, wherein a flat portion is formed at a tip of the elastic sheath body.
  6. 　前記部材本体は、前記中空針の基部周縁から広がったフランジ部を有し、かつ前記弾性鞘体の基部が前記フランジ部の面に沿って広がるフランジ状基部を有している、請求項１～５のいずれか１項に記載の針付き接続部材。 The member main body has a flange portion extending from a peripheral edge of the base portion of the hollow needle, and a base portion of the elastic sheath body has a flange-like base portion extending along the surface of the flange portion. The connecting member with a needle according to any one of 5.
  7. 　前記薬液容器接続部が、接続する薬液容器に設けられた管状接続部と接続できるように構成された接続管部を有している、請求項１～６のいずれか１項に記載の針付き接続部材。 The needle-attached device according to any one of claims 1 to 6, wherein the chemical liquid container connecting portion has a connecting pipe portion configured to be connected to a tubular connecting portion provided in a chemical liquid container to be connected. Connection member.
  8. 　前記部材本体の中空針が立設された面側には、バイアル瓶の口部が装着されるように構成されたバイアル瓶係合部が設けられている、請求項１～７のいずれか１項に記載の針付き接続部材。 The vial engaging portion configured to be fitted with a mouth portion of a vial is provided on a surface side of the member main body on which the hollow needle is erected. The connecting member with a needle according to item.
  9. 　前記薬液容器接続部が、接続する薬液容器に設けられた管状ネジ部に螺着できるように構成された接続ネジ部を有している、請求項１～８のいずれか１項に記載の針付き接続部材。 The needle according to any one of claims 1 to 8, wherein the chemical solution container connecting portion has a connection screw portion configured to be screwed to a tubular screw portion provided in the chemical solution container to be connected. With connecting member.
  10. 　請求項１～８のいずれか１項に記載の針付き接続部材と、管状接続部が設けられた薬液容器とを備え、針付き接続部材に設けられた接続管部と、薬液容器の管状接続部とが薬液が流通できるように接続されている、薬剤溶解キット。 A connecting member with a needle according to any one of claims 1 to 8 and a chemical liquid container provided with a tubular connecting part, a connecting pipe part provided in the connecting member with a needle, and a tubular connection of the chemical liquid container A drug dissolution kit that is connected to a part so that a chemical solution can be distributed.
  11. 　請求項９に記載の針付き接続部材と、管状ネジ部が設けられた薬液容器とを備え、針付き接続部材に設けられた接続ネジ部と、薬液容器の管状ネジ部とが薬液が流通できるように、螺着により接続されている、薬剤溶解キット。 A connecting member with a needle according to claim 9 and a chemical solution container provided with a tubular screw portion, and the connecting screw portion provided in the connecting member with a needle and the tubular screw portion of the chemical solution container can circulate the chemical solution. As such, the drug dissolution kit is connected by screwing.
  12. 　前記薬液容器は、収容している薬液を流出させるための薬液流出口が設けられている、請求項１０又は１１に記載の薬剤溶解キット。 The chemical solution kit according to claim 10 or 11, wherein the chemical solution container is provided with a chemical solution outlet for allowing the contained chemical solution to flow out.
  13. 　前記針付き接続部材又は前記薬液容器に、薬剤溶解キットを吊下げ支持できるように構成された吊り具が設けられた、請求項１０又は１２に記載の薬剤溶解キット。 13. The drug dissolution kit according to claim 10 or 12, wherein the connecting member with the needle or the drug solution container is provided with a lifting tool configured to suspend and support the drug dissolution kit.
  14. 　請求項９に記載の針付接続部材と、管状ネジ部が設けられた薬液容器とを備え、前記針付き接続部材に設けられた前記接続ネジ部と前記薬液容器の前記管状ネジ部とが着脱できるように接続されており、この前記接続ネジ部と前記管状ネジ部が共にルアーロック式である、薬剤溶解キット。 A connecting member with a needle according to claim 9 and a chemical solution container provided with a tubular screw portion, wherein the connecting screw portion provided in the connecting member with a needle and the tubular screw portion of the chemical solution container are attached and detached. The drug dissolution kit is connected so that the connection screw portion and the tubular screw portion are both luer-locked.
PCT/JP2013/063788 2012-05-17 2013-05-17 Needle equipped connecting member, and drug dissolution kit WO2013172449A1 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CN201380024984.0A CN104271104B (en) 2012-05-17 2013-05-17 Connecting part with a needle, dissolution kit
KR20147033447A KR20150014474A (en) 2012-05-17 2013-05-17 Needle equipped connecting member, and drug dissolution kit
JP2013527196A JP6234225B2 (en) 2012-05-17 2013-05-17 Connecting member with needle, drug dissolution kit
KR1020187009299A KR20180037071A (en) 2012-05-17 2013-05-17 Needle equipped connecting member, and drug dissolution kit
IN9433DEN2014 IN2014DN09433A (en) 2012-05-17 2014-11-10
PH12014502543A PH12014502543A1 (en) 2012-05-17 2014-11-14 Needle-equipped connecting member, and drug dissolution kit

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2012113517 2012-05-17
JP2012-113517 2012-05-17

Publications (1)

Publication Number Publication Date
WO2013172449A1 true WO2013172449A1 (en) 2013-11-21

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PCT/JP2013/063788 WO2013172449A1 (en) 2012-05-17 2013-05-17 Needle equipped connecting member, and drug dissolution kit

Country Status (6)

Country Link
JP (1) JP6234225B2 (en)
KR (2) KR20150014474A (en)
CN (1) CN104271104B (en)
IN (1) IN2014DN09433A (en)
PH (1) PH12014502543A1 (en)
WO (1) WO2013172449A1 (en)

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Also Published As

Publication number Publication date
KR20180037071A (en) 2018-04-10
KR20150014474A (en) 2015-02-06
PH12014502543B1 (en) 2015-01-21
CN104271104B (en) 2018-05-22
PH12014502543A1 (en) 2015-01-21
JP6234225B2 (en) 2017-11-22
CN104271104A (en) 2015-01-07
IN2014DN09433A (en) 2015-07-17
JPWO2013172449A1 (en) 2016-01-12

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