EP3498251A1 - Connecteur, récipient de médicament fixé à un connecteur, dispositif d'alimentation en médicament liquide - Google Patents

Connecteur, récipient de médicament fixé à un connecteur, dispositif d'alimentation en médicament liquide Download PDF

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Publication number
EP3498251A1
EP3498251A1 EP17839548.9A EP17839548A EP3498251A1 EP 3498251 A1 EP3498251 A1 EP 3498251A1 EP 17839548 A EP17839548 A EP 17839548A EP 3498251 A1 EP3498251 A1 EP 3498251A1
Authority
EP
European Patent Office
Prior art keywords
inner tube
end side
connector
outer tube
distal end
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
EP17839548.9A
Other languages
German (de)
English (en)
Other versions
EP3498251A4 (fr
EP3498251B1 (fr
Inventor
Takeshi Oguro
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nipro Corp
Original Assignee
Nipro Corp
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 Nipro Corp filed Critical Nipro Corp
Publication of EP3498251A1 publication Critical patent/EP3498251A1/fr
Publication of EP3498251A4 publication Critical patent/EP3498251A4/fr
Application granted granted Critical
Publication of EP3498251B1 publication Critical patent/EP3498251B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—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
    • 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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • 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
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration

Definitions

  • the present invention relates to a connector, a connector-attached drug container, and a liquid drug transfer device for use in mixing a drug and a liquid drug to prepare a drug solution.
  • a conventional liquid drug transfer device is disclosed in, for example, Japanese National Patent Publication No. 2016-511662 (PTL 1).
  • the liquid drug transfer device disclosed in PTL 1 includes a syringe (drug container), a vial with its mouth sealed by an elastic lid, a connecting tool (connector) connected to a distal end of the syringe, and a coupling tool connecting the connecting tool and the vial to each other.
  • the coupling tool has a needle having a liquid hole and sticking into the elastic lid.
  • the connecting tool includes a tubular portion that is screwed with a screwing portion of the syringe and is axially movable relative to the needle.
  • the tubular portion has a hollow passage at one end thereof and a needle insertion attachment portion at the other end thereof.
  • the hollow passage is in communication with the interior of the syringe while being screwed with the syringe.
  • the needle insertion attachment portion can receive the proximal end side of the needle.
  • the liquid hole of the needle is provided so as to be in communication with the hollow passage.
  • the needle is stuck into the elastic lid of the vial and is attached to the vial, and subsequently, the syringe is brought closer to the one end side of the tubular portion, thereby screwing the tubular portion with the screwing portion of the syringe.
  • the proximal end side of the needle is inserted into the needle insertion attachment portion of the syringe screwed with the tubular portion, and the syringe is pushed toward the vial. This causes the proximal end side of the needle to enter the tubular portion so as to approach the one end of the tubular portion.
  • the distal end side of the hollow passage passes through a sealing film provided on the proximal end side of the needle, so that the interior of the syringe and the interior of the vial are in communication with each other through the hollow passage of the tubular portion and the liquid hole of the needle.
  • the liquid drug contained in the syringe is transferred into the drug container, and the liquid drug and the drug contained in the vial are mixed together, thus preparing a drug solution.
  • the liquid drug transfer device disclosed in PTL 1 has a configuration in which one end side of the tubular portion is screwed with the screwing portion of the syringe to attach the syringe to the connecting tool. Consequently, when the position of the liquid drug transfer device is changed, for example, the syringe and the coupling tool may be unscrewed from each other to cause leakage of the liquid contained in the syringe.
  • the present invention has been made in view of the above problem, and has an object to provide a connector, a connector-attached drug container, and a liquid drug transfer device capable of preventing a drug container from becoming detached from a connecting tool.
  • a connector according to the present invention includes an outer tube, an inner tube held by the outer tube while being inserted into the outer tube, a fluid channel which has a hollow passage and is fixed to a distal end side of the inner tube and accommodated in the outer tube, and a ratchet mechanism which allows rotation of the inner tube in one direction while restricting rotation of the inner tube in the other direction.
  • the inner tube includes an insertion attachment portion which is provided on a proximal end side of the inner tube and with which a distal end side of a drug container is screwed to be attached thereto by insertion.
  • the ratchet mechanism restricts rotation of the inner tube together with the drug container in a screwing direction and allows the inner tube to rotate freely relative to the outer tube together with the drug container in an unscrewing direction opposite to the screwing direction.
  • the ratchet mechanism preferably includes a ratchet tooth fixed relative to the inner tube and provided to project radially outwardly of the inner tube, and a ratchet pawl provided on a proximal end side of the outer tube and projecting inwardly of the outer tube from an inner peripheral surface of the outer tube.
  • the connector according to the present invention further includes a ratchet tooth support supporting the ratchet tooth.
  • the ratchet tooth support preferably includes a flange projecting radially outwardly from an outer peripheral surface of the inner tube, and a wall extending in a tube axis direction of the inner tube and having one end side connected to the flange and the other end side serving as a free end.
  • the ratchet tooth is preferably provided to project radially outwardly from the wall.
  • the connector according to the present invention preferably further includes a valve having a valve hole which is provided so as to open and close and closes a distal end side of the outer tube.
  • a connector-attached drug container includes a connector and a drug container.
  • the connector includes an outer tube, an inner tube held by the outer tube while being inserted into the outer tube, a fluid channel which has a hollow passage and is fixed to a distal end side of the inner tube and accommodated in the outer tube, and a ratchet mechanism which allows rotation of the inner tube in one direction while restricting rotation of the inner tube in the other direction.
  • the drug container includes a tubular container and a plunger inserted from a proximal end side of the tubular container.
  • the tubular container has a nozzle provided on a distal end side of the tubular container and a surrounding portion surrounding at least a proximal end side of the nozzle, and contains a liquid drug.
  • the inner tube includes an insertion attachment portion which is provided on a proximal end side of the inner tube and with which a distal end side of the drug container is screwed to be attached thereto by insertion.
  • the surrounding portion has a screwing portion screwed with the insertion attachment portion of the connector.
  • the ratchet mechanism restricts rotation of the inner tube together with the drug container in a screwing direction and allows the inner tube to rotate freely relative to the outer tube together with the drug container in an unscrewing direction opposite to the screwing direction.
  • the screwing portion is screwed with the insertion attachment portion to connect the connector to the distal end side of the drug container.
  • a liquid drug transfer device includes a connector, a first coupling tool, and a drug container.
  • the connector includes an outer tube, an inner tube held by the outer tube while being inserted into the outer tube, a fluid channel which has a hollow passage and is fixed to a distal end side of the inner tube and accommodated in the outer tube, and a ratchet mechanism which allows rotation of the inner tube in one direction while restricting rotation of the inner tube in the other direction.
  • the first coupling tool has a mouth. The mouth is tightly closed by an elastic stopper body.
  • the first coupling tool couples a vial containing a drug and the connector to each other.
  • the drug container includes a tubular container and a plunger inserted from a proximal end side of the tubular container.
  • the tubular container has a nozzle provided on a distal end side of the tubular container and a surrounding portion surrounding at least a proximal end side of the nozzle, and contains a liquid drug.
  • the inner tube includes an insertion attachment portion which is provided on a proximal end side of the inner tube and with which the distal end side of drug container is screwed to be attached thereto by insertion.
  • the surrounding portion has a screwing portion screwed with the insertion attachment portion of the connector.
  • the ratchet mechanism restricts rotation of the inner tube together with the drug container in a screwing direction and allows the inner tube to rotate freely together with the drug container relative to the outer tube in an unscrewing direction opposite to the screwing direction.
  • the first coupling tool includes a tubular portion which is inserted into a distal end side of the outer tube of the connector to cause a distal end side of the fluid channel to be inserted thereinto, and a puncture needle which has a liquid hole being in communication with an interior of the tubular portion and is provided so as to stick into an elastic stopper body of the vial.
  • the screwing portion is screwed with the insertion attachment portion to connect the connector to the distal end side of the drug container and in a state in which the puncture needle sticks into the elastic stopper body of the vial to insert the distal end side of the fluid channel into the tubular portion, an interior of the vial, the liquid hole, an interior of the tubular portion, the hollow passage of the fluid channel, an interior of the inner tube, and an interior of the nozzle are in communication with each other to allow transfer of the liquid drug contained in the drug container into the vial.
  • the present invention can provide a connector, a connector-attached drug container, and a liquid drug transfer device capable of preventing a drug container from becoming detached from a connecting tool.
  • Fig. 1 is a sectional view of components of a liquid drug transfer device and a vial according to Embodiment 1. With reference to Fig. 1 , the liquid drug transfer device according to Embodiment 1 will be described.
  • a liquid drug transfer device 100 connects a syringe 10 serving as a drug container, a connector 20 serving as a connecting tool, a first coupling tool 30 serving as a first coupling tool, and a vial 40 to each other to cause the interior of syringe 10 and the interior of vial 40 to be in communication with each other, allows a liquid drug L contained in syringe 10 to be transferred into vial 40, and mixes a drug (not shown) contained in vial 40 and liquid drug L in vial 40, thereby preparing a drug solution.
  • liquid drug transfer device 100 includes syringe 10, connector 20, and first coupling tool 30.
  • Syringe 10 includes a tubular container 11 which is open at its opposite ends, and a plunger 17.
  • Tubular container 11 contains liquid drug L.
  • Liquid drug L is an object to be contained which forms a drug.
  • Tubular container 11 has a nozzle 12 provided on its distal end side and a surrounding portion 13 surrounding nozzle 12.
  • a screwing portion 14 having a spiral shape is provided on the inner peripheral surface of surrounding portion 13.
  • Plunger 17 is inserted into tubular container 11 from the proximal end side of tubular container 11.
  • a gasket 16 is provided on the distal end side of plunger 17.
  • Gasket 16 is provided to be freely slidable within tubular container 11 and keeps the inner peripheral surface of tubular container 11 and gasket 16 liquid tight.
  • Liquid drug L is contained in the space defined by tubular container 11 and gasket 16.
  • Gasket 16 may be, for example, natural rubber, butyl rubber, chlorinated butyl rubber, ethylene-butadiene rubber, or thermoplastic elastomer.
  • Vial 40 contains a drug (not shown).
  • Vial 40 includes a container body 41 having a mouth 42, and an elastic stopper body 43 sealing mouth 42.
  • Container body 41 may be, for example, a glass container or a resin container.
  • Elastic stopper body 43 may be, for example, a rubber member or a thermoplastic elastomer resin.
  • Fig. 2 is a perspective view of the connector according to Embodiment 1.
  • Fig. 3 is a perspective view showing the interior on the proximal end side of the connector according to Embodiment 1.
  • Fig. 4 is a sectional view of the connector according to Embodiment 1. With reference to Figs. 2 to 4 , connector 20 serving as the connecting tool according to Embodiment 1 will be described.
  • Connector 20 includes an outer tube 210, an inner tube 220, a needle 230, a ratchet mechanism 240, a valve 250, and a ratchet tooth support 260.
  • Outer tube 210 includes a first outer tube 211, a second outer tube 212, and a third outer tube 213.
  • First outer tube 211 is located on the distal end side of outer tube 210.
  • First outer tube 211 accommodates the distal end side of inner tube 220 and the distal end side of needle 230.
  • First outer tube 211 is configured to allow one end side of first coupling tool 30, more specifically, a tubular portion 310 side (cap 350 side) of first coupling tool 30, which will be described below, to be inserted thereinto.
  • a lid 215 is attached to a distal end 211a of first outer tube 211.
  • Lid 215 has an annular shape.
  • a through-hole 216 passing through lid 215 thicknesswise is formed in the center portion of lid 215.
  • Through-hole 216 has an outside diameter slightly greater than the outside diameter of cap 350 of first coupling tool 30, which will be described below. Consequently, in coupling of connector 20 to first coupling tool 30, cap 350 and accordingly tubular portion 310 are positioned to allow needle tube 231 of needle 230 to be reliably guided into tubular portion 310.
  • Valve 250 is sandwiched between lid 215 and distal end 211a of first outer tube 211. Valve 250 closes the distal end side of outer tube 210. Valve 250 has a valve hole 251 provided to open and close in accordance with the insertion and removal of the one end side (cap 350 side) of first coupling tool 30. Valve hole 251 is provided like a slit.
  • Valve 250 is formed of an elastic member.
  • the material for the elastic member of valve 250 may be any appropriate material that can restore its original shape when a load exerted on valve 250 is removed.
  • the material may be a rubber material such as isoprene rubber, butyl rubber, or silicone rubber.
  • Second outer tube 212 is located between first outer tube 211 and third outer tube 213 and connects first outer tube 211 and third outer tube 213 to each other.
  • the inside diameter of second outer tube 212 is greater than the inside diameter of first outer tube 211.
  • Second outer tube 212 accommodates a middle portion of inner tube 220 (specifically, the proximal end side of second inner tube 222), which will be described below, a hitting portion 223, which will be described below, and an O-ring 270.
  • Third outer tube 213 is located on the proximal end side of outer tube 210.
  • Third outer tube 213 mainly accommodates the proximal end side of inner tube 220.
  • the inside diameter of third outer tube 213 is greater than the inside diameter of second outer tube 212.
  • Third outer tube 213 allows a ratchet tooth 241, which will be described below, to rotate around the central axis of outer tube 210.
  • Inner tube 220 is held by outer tube 210 while being inserted into outer tube 210.
  • the tube axis of inner tube 220 coincides with the tube axis of outer tube 210.
  • Inner tube 220 is held by outer tube 210 so as to rotate around the tube axis of inner tube 220.
  • O-ring 270 is press-fitted between inner tube 220 and outer tube 210, so that inner tube 220 is rotatably held by the outer tube.
  • O-ring 270 is located between a flange 261 and hitting portion 223 in the tube axis direction. This prevents O-ring 270 from becoming detached from inner tube 220.
  • Inner tube 220 has a first inner tube 221 and a second inner tube 222.
  • First inner tube 221 has a tubular shape.
  • First inner tube 221 is provided on the proximal end side of inner tube 220.
  • First inner tube 221 is mainly located inside third outer tube 213.
  • a spiral protrusion 225 is provided on the outer peripheral surface of first inner tube 221.
  • a spiral groove 226 is formed along spiral protrusion 225. Spiral groove 226 is screwed with screwing portion 14 of syringe 10.
  • First inner tube 221 functions as an insertion attachment portion with which the distal end side of syringe 10 is screwed to be attached thereto by insertion.
  • Second inner tube 222 has a tubular shape. Second inner tube 222 is provided on the distal end side of inner tube 220. The interior of second inner tube 222 is in communication with the interior of first inner tube 221. Second inner tube 222 is inserted into second outer tube 212 and first outer tube 211. A needle hub 232 of needle 230, which will be described below, is inserted into second inner tube 222.
  • Hitting portion 223 is provided on the outer periphery of second inner tube 222.
  • Hitting portion 223 has an annular shape.
  • Hitting portion 223 projects radially outwardly from the outer peripheral surface of second inner tube 222.
  • Hitting portion 223 hits the end on the proximal end side of first outer tube 211. Consequently, inner tube 220 is positioned.
  • Needle 230 is fixed to the distal end side of inner tube 220 and is accommodated in outer tube 210.
  • Needle 230 includes a needle tube 231 having a hollow passage 231a and needle hub 232 holding needle tube 231.
  • Hollow passage 231a is configured to allow a fluid to flow therethrough.
  • needle 230 having hollow passage 231a is configured to allow a liquid drug to flow therethrough and functions as a fluid channel.
  • Needle hub 232 has a closed tubular shape. Needle hub 232 is attached to second inner tube 222. With needle hub 232 attached to second inner tube 222, the interior of needle hub 232 is in fluid-tight communication with the interior of first inner tube 221.
  • Hollow passage 231a of needle tube 231 is in fluid-tight communication with the interior of first inner tube 221 through the interior of needle hub 232.
  • Needle tube 231 is coated with a coating 233.
  • Coating 233 is formed of, for example, a rubber cap. Coating 233 is elastically provided. Coating 233 is provided to allow needle tube 231 to stick thereinto.
  • Ratchet mechanism 240 restricts rotation of inner tube 220 together with syringe 10 in the screwing direction (DR1 direction) in the insertion attachment state in which the distal end of the syringe is attached by insertion to first inner tube 221 (insertion attachment portion).
  • Ratchet mechanism 240 allows inner tube 220 to rotate freely relative to outer tube 210 together with syringe 10 in the unscrewing direction (DR2 direction) in the above insertion attachment state.
  • the screwing direction is a direction in which syringe 10 is rotated when the distal end side of syringe 10 is screwed with inner tube 220, and the unscrewing direction is opposite to the screwing direction.
  • Ratchet mechanism 240 has ratchet teeth 241 and a plurality of ratchet pawls 242.
  • Ratchet pawls 242 have, for example, a plate shape. Ratchet pawls 242 extend along the tube axis of outer tube 210. Ratchet pawls 242 are provided to project from the inner peripheral surface of third outer tube 213 toward the interior of third outer tube 213. Ratchet pawls 242 are circumferentially provided at pitches of 90°. Ratchet pawls 242 are provided to project in different directions. The directions in which ratchet pawls 242 adjacent to each other anticlockwise project differ by 90° around the central axis of outer tube 210.
  • Ratchet teeth 241 are provided to project radially outwardly of inner tube 220. Specifically, each of ratchet teeth 241 is provided to project radially outwardly of inner tube 220 from a corresponding wall 262, which will be described below.
  • Ratchet tooth 241 includes a hitting portion 241a that can hit against a tip 242a of ratchet pawl 242 and a curved portion 241b slidable toward ratchet pawl 242.
  • Hitting portion 241a hits against tip 242a of ratchet pawl 242 when the distal end of syringe 10 is screwed to inner tube 220 (specifically, first inner tube 221) and syringe 10 is then rotated further in the screwing direction (DR1 direction). This restricts rotation of inner tube 220 together with syringe 10 in the screwing direction (DR1 direction) in the insertion attachment state described above.
  • Curved portion 241b is generally formed in a fan shape and is configured to be slidable toward ratchet pawl 242 located forward in the rotation direction in the unscrewing direction (DR2 direction).
  • the holding force by which outer tube 210 holds inner tube 220 is smaller than the frictional force between syringe 10 and inner tube 220 which is required to unscrew syringe 10 from the insertion attachment state in which the distal end of syringe 10 is attached to first inner tube 221.
  • rotating syringe 10 in the unscrewing direction in the above insertion attachment state causes syringe 10 to rotate in the unscrewing direction together with inner tube 220 without being unscrewed from inner tube 220.
  • ratchet tooth 241 slides toward ratchet pawl 242, which allows inner tube 220 to rotate freely relative to outer tube 210 together with syringe 10 in the unscrewing direction (DR2 direction).
  • Ratchet teeth 241 is fixed relative to inner tube 220.
  • Ratchet teeth 241 are supported by ratchet tooth support 260.
  • Ratchet tooth support 260 includes flange 261 and walls 262.
  • Flange 261 projects radially outwardly of first inner tube 221 from the outer peripheral surface of first inner tube 221.
  • Flange 261 has an approximately annular shape.
  • Walls 262 extend along the tube axis of inner tube 220. One end side of each of walls 262 is connected to the peripheral portion of flange 261. The other end side of each of walls 262 is a free end. This allows walls 262 to flexibly deform. In the insertion attachment state of syringe 10, when syringe 10 is rotated in the unscrewing direction, flexible deformation of wall 262 reduces a sliding resistance between ratchet tooth 241 and ratchet pawl 242, thereby facilitating the rotations of syringe 10 and inner tube 220.
  • Walls 262 are spaced circumferentially. Walls 262 are provided corresponding to the number of ratchet teeth 241.
  • Fig. 5 is a perspective view of the first coupling tool according to Embodiment 1 with one end side of the first coupling tool directed upward.
  • Fig. 6 is a perspective view of the first coupling tool according to Embodiment 1 with the other end side of the first coupling tool directed upward.
  • Fig. 7 is a sectional view of the first coupling tool according to Embodiment 1. With reference to Figs. 5 to 7 , first coupling tool 30 according to Embodiment 1 will be described.
  • First coupling tool 30 includes a tubular portion 310, a puncture needle 320, a vial insertion attachment portion 330, a port 340, and a cap 350.
  • Tubular portion 310 is provided on one end side (proximal end side) of first coupling tool 30.
  • Tubular portion 310 is configured to accommodate the distal end side of needle 230 (specifically, the distal end side of needle tube 231).
  • Tubular portion 310 is covered with cap 350.
  • Cap 350 includes a tubular main body 351 and a closing film 352.
  • Main body 351 covers tubular portion 310.
  • Closing film 352 closes one end side of main body 351 and also closes one end side of tubular portion 310.
  • Closing film 352 has a first film body 353 and a second film body 354.
  • Closing film 352 is formed of first film body 353 and second film body 354 overlaid in the tube axis direction of cap 350.
  • Closing film 352 is formed as an integral elastic member of first film body 353 and second film body 354 layered to keep intimate contact.
  • Puncture needle 320 is provided on the other end side (distal end side) of first coupling tool 30. Puncture needle 320 is provided to stick into elastic stopper body 43 of vial 40. Puncture needle 320 is arranged in line with tubular portion 310 along the axis of tubular portion 310.
  • Puncture needle 320 has a first hole 321 serving as a liquid hole and a second hole 322. One end side of first hole 321 is connected to the other end side of tubular portion 310. This allows first hole 321 to be in communication with the interior of tubular portion 310. The other end side of first hole 321 is open on the outer peripheral surface of puncture needle 320.
  • First hole 321 is preferably formed at a position deviated from the axis center of puncture needle 320. This reduces the generation of an aerosol floating for a long period of time due to direct spraying of liquid drug L to the drug in vial 40 when liquid drug L is transferred from syringe 10 into vial 40.
  • Second hole 322 is separate from first hole 321. One end side of second hole 322 is connected to port 340. The other end side of second hole 322 is open on the other end side of puncture needle 320.
  • Port 340 serves to dissipate the gas in vial 40 to the outside of the system when the internal pressure of vial 40 rises.
  • An aerosol filter 341 is disposed in port 340. Aerosol filter 341 prevents the aerosol which is contained in the gas and contains components of liquid drug L, drug, drug solution, and the like from leaking outside the system.
  • a hydrophobic material such as water-repellent resins including polytetrafluoroethylene and ethylene-tetrafluoroethylene, and resins and fibers each having a water-repellent surface.
  • the poser size, structure, and thickness of aerosol filter 341 are appropriately selected.
  • An aerosol floating for a long period of time usually has a diameter of about 10 nm to 500 nm.
  • a hydrophilic filter, a filter having positive or negative electrostatic property, active carbon, or the like may be combined compositely to form aerosol filter 341.
  • First coupling tool 30 may have a configuration devoid of aerosol filter 341.
  • Vial insertion attachment portion 330 has a tubular shape. Vial insertion attachment portion 330 is provided to be attachable to mouth 42 of vial 40. The inside diameter of vial insertion attachment portion 330 is provided to be slightly smaller than that of mouth 42. With vial insertion attachment portion 330 attached to mouth 42, vial insertion attachment portion 330 is widened outwardly, and the inner peripheral surface of vial insertion attachment portion 330 catches the outer peripheral portion of mouth 42.
  • a cutout 331 is provided in vial insertion attachment portion 330. Providing cutout 331 facilitates flexible deformation of vial insertion attachment portion 330, so that vial insertion attachment portion 330 is attached by insertion to mouth 42.
  • vial insertion attachment portion 330 The inner peripheral surface of vial insertion attachment portion 330 is provided to be slidable on the outer periphery of mouth 42. With vial insertion attachment portion 330 inserted into mouth 42, first coupling tool 30 can be pushed toward vial 40.
  • Vial insertion attachment portion 330 may be shaped integrally with puncture needle 320 and tubular portion 310 described above.
  • the material for vial insertion attachment portion 330, puncture needle 320, and tubular portion 310 is preferably ABS resin, SB resin, polycarbonate, or polystyrene.
  • First coupling tool 30 may further include a protective cap 360.
  • Protective cap 360 protects puncture needle 320.
  • Protective cap 360 is removed from puncture needle 320 when first coupling tool 30 is attached to vial 40.
  • liquid drug transfer device 100 In use of liquid drug transfer device 100, first, syringe 10 is attached to connector 20.
  • Fig. 8 is a sectional view showing a state in which the syringe according to Embodiment 1 is attached to the connector by insertion. As shown in Fig. 8 , in attachment of syringe 10 to connector 20, the distal end side of syringe 10 is inserted from the proximal end side of connector 20 into first inner tube 221 with the distal end of syringe 10 directed upward.
  • Syringe 10 is rotated in the screwing direction, and screwing portion 14 of syringe 10 is screwed with spiral groove 226 formed on the outer peripheral side of first inner tube 221, thereby attaching syringe 10 to the connector. Consequently, a connector-attached syringe with connector 20 attached by insertion to the distal end side of syringe 10, which serves as a connector-attached drug container, is provided.
  • syringe 10 In the insertion attachment state in which syringe 10 is attached to the connector, syringe 10 can rotate together with inner tube 220 in the screwing direction (DR1) and the unscrewing direction (DR2 direction) as described above.
  • Fig. 9 is a bottom view showing a first state of the connector in the insertion attachment state shown in Fig. 8 .
  • Fig. 9 shows only connector 20 viewed from the proximal end side and does not show syringe 10.
  • Fig. 10 is a bottom view showing a second state of the connector in the insertion attachment state shown in Fig. 8 .
  • Fig. 10 shows only connector 20 viewed from the proximal end side and does not show syringe 10.
  • the holding force by which outer tube 210 holds inner tube 220 is smaller than the frictional force between syringe 10 and inner tube 220 which is required to unscrew syringe 10 from the above insertion attachment state. Consequently, rotating syringe 10 in the unscrewing direction (DR2) in the above insertion attachment state causes syringe 10 to rotate together with inner tube 220 in the unscrewing direction without being unscrewed from inner tube 220.
  • Syringe 10 and inner tube 220 rotate freely together relative to outer tube 210 as described above, thus preventing syringe 10 from becoming detached from connector 20. Consequently, a leakage of liquid drug L from the interior of syringe 10 can be prevented.
  • FIG. 11 is a sectional view showing the state in which the first coupling tool is connected to the vial according to Embodiment 1. As shown in Fig. 11 , first coupling tool 30 is pressed down toward vial 40 with puncture needle 320 puncturing elastic stopper body 43 of vial 40, thereby attaching vial insertion attachment portion 330 to mouth 42. Consequently, first coupling tool 30 is connected to vial 40.
  • syringe 10 may be attached to connector 20 after first coupling tool 30 is connected to vial 40.
  • Fig. 12 is a sectional view showing a state in which the connector-attached syringe, the first coupling tool, and the vial according to Embodiment 1 are connected to each other.
  • a connector-attached syringe is attached by insertion to first coupling tool 30 connected to vial 40, and vial 40 and connector 20 are coupled to each other through first coupling tool 30.
  • first coupling tool 30 is pressed down toward first coupling tool 30 such that the one end side (cap 350 side) of first coupling tool 30 is inserted into outer tube 210 through valve hole 251.
  • coating 233 covering needle tube 231 contacts closing film 352 closing the interior of cap 350 and also closing the opening on one end side of tubular portion 310. Further pressing down the connector-attached syringe elastically deforms coating 233, so that needle tube 231 passes through coating 233 and sticks into first film body 353 and second film body 354. As a result, the distal end side of needle 230 (specifically, the distal end side of needle tube 231) is inserted into tubular portion 310. At this time, first film body 353 and second film body 354 adhere to the periphery of needle tube 231, thus allowing hollow passage 231a and the interior of tubular portion 310 to be in communication with each other while keeping the fluid-tight state.
  • screwing portion 14 is screwed with spiral groove 226 with the distal end side of nozzle 12 coming in inner tube 220 of connector 20.
  • This allows the interior of vial 40, first hole 321, the interior of tubular portion 310, hollow passage 231a of needle 230, the interior of inner tube 220, and the interior of nozzle 12 to be in communication with each other in the state in which connector 20 is attached by insertion to the distal end side of syringe 10 and in the state in which puncture needle 320 sticks into elastic stopper body 43 of vial 40 to cause the distal end side of needle 230 to be inserted into tubular portion 310.
  • Pressing down plunger 17 of syringe 10 causes liquid drug L contained in syringe 10 to be transferred into vial 40 so as to be sprayed onto the inner wall of vial 40 through the interior of nozzle 12, the interior of inner tube 220, the interior of hollow passage 231a, the interior of tubular portion 310, and first hole 321.
  • vial 40 rises, causing the gas contained in vial 40 to be discharged out of the system from port 340 through second hole 322 formed in puncture needle 320.
  • aerosol filter 341 prevents the aerosol generated by spraying of liquid drug L from being discharged out of the system.
  • the drug in vial 40 is dissolved in liquid drug L which has been transferred, thereby preparing a desired drug solution.
  • liquid drug transfer device 100 and vial 40 are inverted vertically while liquid drug transfer device 100 and vial 40 are kept connected. That is to say, the positions of liquid drug transfer device 100 and vial 40 are changed such that vial 40 is positioned above syringe 10 and syringe 10 is positioned below vial 40.
  • Pulling plunger 17 downward in this state causes the drug solution to be transferred from vial 40 into syringe 10 through the interior of vial 40, first hole 321, the interior of tubular portion 310, hollow passage 231a of needle 230, the interior of inner tube 220, and the interior of nozzle 12.
  • the drug solution is drawn and taken into syringe 10 up to the nominal capacity.
  • the connector-attached syringe is detached from first coupling tool 30 in order to cause the drug solution drawn into syringe 10 to be charged into the liquid drug contained in infusion container 50 (see Fig. 13 ) again.
  • the connector-attached syringe is separated away from first coupling tool 30 such that one end side (cap 350 side) of first coupling tool 30 is pulled out of outer tube 210 through valve hole 251.
  • needle tube 231 is removed from first film body 353 and second film body 354.
  • the drug solution which has adhered to the distal end of needle tube 231 in transfer of the prepared drug solution from vial 40 to syringe 101, remains at the distal end of needle tube 231.
  • needle tube 231 When needle tube 231 is removed from first film body 353 and second film body 354, needle tube 231 slides against first film body 353 and second film body 354 with first film body 353 and second film body 354 adhering to the outer peripheral surface of needle tube 231. This causes an action of squeezing needle tube 231 by first film body 353 and second film body 354. Consequently, the drug solution adhering to the outermost surface of needle tube 231 is removed. The drug solution squeezed by first film body 353 and second film body 354 is caught between first film body 353 and second film body 354.
  • valve hole 251 of valve 250 is closed.
  • the first coupling tool is used separately to couple syringe 10 and the infusion container containing the liquid drug to each other, thereby transferring the drug solution into the infusion container.
  • connector 20 allows ratchet mechanism 240 to restrict rotation of inner tube 220 together with syringe 10 in the screwing direction and allow inner tube 220 to rotate freely relative to outer tube 210 together with syringe 10 in the unscrewing direction opposite to the screwing direction in the state in which syringe 10 and connector 20 are connected to each other, that is, the state in which connector 20 is attached by insertion to the distal end of syringe 10. Consequently, syringe 10 cannot be detached from connector 20 in the state in which syringe 10 and connector 20 are connected to each other. This prevents leakage of the liquid drug from syringe 10 due to unintentional detachment of connector 20 from syringe 10.
  • needle tube 231 of connector 20 is coated with coating 233, thus preventing leakage of the liquid drug of syringe 10 also from connector 20. Further, providing valve 250 that closes the distal end side of outer tube 210 of connector 20 can further prevent leakage of the liquid drug from connector 20.
  • liquid drug transfer device 100 including a connector-attached syringe with connector 20 attached by insertion to the distal end of syringe 10 and the first coupling tool
  • syringe 10 is not detached from connector 20 even when liquid drug transfer device 100 is out of position. That is to say, syringe 10 and connector 20 are detached from first coupling tool 30 with syringe 10 connected to connector 20. This prevents leakage of the liquid drug from syringe 10 as described above.
  • coating 233 returns to its original state, and coating 233 coats needle tube 231 of connector 20, thus preventing leakage of the liquid drug into syringe 10 from the connector 20 side.
  • Fig. 13 is a perspective view showing a state in which a connector-attached syringe, a second coupling tool, and an infusion container according to Embodiment 2 are connected to each other.
  • Fig. 14 is a sectional view of components of a liquid drug transfer device and the infusion container according to Embodiment 2. With reference to Figs. 13 and 14 , the components of a liquid drug transfer device 100A and an infusion container 50 according to Embodiment 2 will be described.
  • Infusion container 50 contains a liquid drug.
  • Infusion container 50 includes a container body 51 having a mouth 52 and an elastic stopper body 53 sealing mouth 52.
  • Mouth 52 has a first frame body 521 passing through container body 51 and a second frame body 522 attached to the tip end of first frame body 521.
  • First frame body 521 and second frame body 522 have a tubular shape.
  • First frame body 521 and second frame body 522 are formed of, for example, a resin member.
  • Elastic stopper body 53 is held by second frame body 522.
  • Elastic stopper body 53 may be, for example, a rubber member or thermoplastic elastomer resin.
  • Liquid drug transfer device 100A uses the drug solution prepared in Embodiment 1 as the liquid drug contained in syringe 10 and causes this drug solution to be transferred to infusion container 50 serving as a drug container.
  • Liquid drug transfer device 100A includes connector 20, syringe 10, and a second coupling tool 30A serving as the first coupling tool.
  • Syringe 10 has a configuration substantially identical to that of syringe 10 according to Embodiment 1, the configuration of which will be omitted.
  • Connector 20 has a configuration substantially identical to that of connector 20 according to Embodiment 1, the configuration of which will be omitted.
  • the connector-attached syringe in which syringe 10 is inserted into connector 20 has a configuration substantially identical to that of the connector-attached syringe according to Embodiment 1.
  • Second coupling tool 30A has an outlet port 380 formed on one end side and a puncture needle 320A formed on the other end side with respect to an axis, where the axis is the direction in which second coupling tool 30A sticks into the plug body of infusion container 50, and is provided with a tubular portion 310 that projects obliquely from the axis.
  • tubular portion 310 of second coupling tool 30A and cap 350 are substantially identical to the configurations of tubular portion 310 of first coupling tool 30 and cap 350.
  • Puncture needle 320A is substantially identical to the configuration of puncture needle 320 of first coupling tool 30.
  • Puncture needle 320A has a first hole 321A serving as a liquid hole and a second hole 322A.
  • First hole 321A is in communication with the interior of tubular portion 310.
  • Second hole 322A is separate from first hole 321A.
  • Second hole 322A is connected to outlet port 380.
  • a closing member 381 that allows a bottle needle of an infusion line to stick thereinto is provided at the tip end of outlet port 35.
  • Closing member 381 is usually a thin film having elasticity so that it allows the bottle needle of the infusion line to stick thereinto, does not allow easy disengagemen by the bottle needle in the sticking position, and does not impair the fluid-tightness.
  • a material for closing member 381 which satisfies the above performance is determined in view of compatibility with a drug in contact with it, and is appropriately selected from among natural rubber, butyl rubber, chlorinated butyl rubber, styrene butadiene rubber, thermoplastic elastomer, and the like.
  • the opening of outlet port 380 preferably has a cylindrical shape having an inside diameter slightly smaller than that of the bottle needle of the infusion line for assisting holding of the bottle needle.
  • a liquid valve (not shown) that can bidirectionally open in response to a predetermined pressure or more is disposed at the other end (lower end side in Fig. 14 ) of tubular portion 310.
  • the liquid valve is configured to allow first hole 321A and the interior of tubular portion 310 to be in communication with each other.
  • the liquid valve opens upon application of a predetermined pressure or more when the drug solution is transferred from syringe 10 to infusion container 50.
  • the liquid valve described above may be a one-way valve that allows a flow of liquid from the interior of tubular portion 310 toward first hole 321A and prohibits a flow in the reverse direction so that the drug solution can be irreversibly transferred from syringe 10 to infusion container 50.
  • liquid drug transfer device 100A A way of using liquid drug transfer device 100A will now be described.
  • second coupling tool 30A is connected to infusion container 50.
  • elastic stopper body 53 is punctured with puncture needle 320A.
  • the connector-attached syringe that contains the drug solution prepared as described above is attached by insertion to second coupling tool 30A to couple infusion container 50 and connector 20 to each other with second coupling tool 30A therebetween.
  • infusion container 50 This allows the interior of infusion container 50, first hole 321A, the interior of tubular portion 310, hollow passage 231a of needle 230, the interior of inner tube 220, and the interior of nozzle 12 to be in communication with each other. Consequently, the drug solution contained in syringe 10 can be transferred into infusion container 50.
  • Pressing down plunger 17 of syringe 10 causes the drug solution contained in syringe 10 to be transferred into infusion container 50 through the interior of nozzle 12, the interior of inner tube 220, the interior of hollow passage 231a, the interior of tubular portion 310, and first hole 321. Consequently, a new drug solution is prepared.
  • Fig. 15 shows an example of the infusion line according to Embodiment 2.
  • an infusion line 400 is formed of infusion container 50, an infusion container 50A, bottle needles 71 and 71A, intravenous chambers 72 and 72A, roller clamps 73 and 73A, tubes 74 and 74A, and connectors 75 and 75A, and the prepared drug solution is administered to a patient.
  • connector 20 As described above, connector 20, the connector-attached syringe, and liquid drug transfer device 100A according to Embodiment 2 can also achieve effects substantially identical to those of Embodiment 1.
  • ratchet mechanism 240 is formed of ratchet tooth 241 and ratchet pawl 242
  • the present invention is not limited thereto.
  • Ratchet pawl 242 may be replaced by a ratchet groove that restricts the rotation of a ratchet tooth in one direction and prohibits the rotation in the other direction.
  • Ratchet tooth 241 may be provided directly in inner tube 220 as long as the attachment by insertion of the distal end of syringe 10 is not affected.
  • ratchet tooth support 260 is formed of inner tube 220.
  • Embodiment 1 described above has illustrated the case in which a syringe and a vial are connected to each other as the manner of using a liquid drug transfer device and Embodiment 2 has illustrated the case in which a syringe and an infusion container are connected to each other as the manner of using a liquid drug transfer device
  • the liquid drug transfer device of the present invention is not limited to such examples.
  • the liquid drug transfer device of the present invention can be used in transfer of any liquid, external leakage of which is desirably prohibited.
  • the liquid drug transfer device of the present invention can be used for transferring a liquid containing pathogenic bacteria, bacteria to be prevented from having resistance, or the like.
  • the liquid drug transfer device according to the present invention can be appropriately used, for example, for transferring a drug solution from a syringe to a drug bag, for transferring an infusion from an infusion line to an empty syringe for sampling, for transferring a liquid specimen containing pathogenic bacteria from a specimen collecting tool to an inspection kit.
  • the liquid drug transfer device according to the present invention can be used for transferring a dangerous solvent such as trichloroethylene or a solution containing an endocrine-disrupting substance.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP17839548.9A 2016-08-09 2017-08-09 Connecteur, récipient de médicament fixé à un connecteur, dispositif d'alimentation en médicament liquide Active EP3498251B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016156513 2016-08-09
PCT/JP2017/028978 WO2018030481A1 (fr) 2016-08-09 2017-08-09 Connecteur, récipient de médicament fixé à un connecteur, dispositif d'alimentation en médicament liquide.

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EP3498251A1 true EP3498251A1 (fr) 2019-06-19
EP3498251A4 EP3498251A4 (fr) 2020-03-04
EP3498251B1 EP3498251B1 (fr) 2021-04-07

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IL257778B (en) * 2018-02-27 2022-07-01 Equashield Medical Ltd Device for securing device connections
CN108168986B (zh) * 2018-03-21 2024-08-30 深圳市鹏一医疗仪器有限公司 全自动液基细胞制片染色一体机及制片染色方法
US11484470B2 (en) * 2019-04-30 2022-11-01 West Pharma. Services IL, Ltd. Liquid transfer device with dual lumen IV spike

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ATE385826T1 (de) 2002-08-12 2008-03-15 Jms Co Ltd Nadelllose öffnung und herstellungsverfahren dafür
US8864725B2 (en) * 2009-03-17 2014-10-21 Baxter Corporation Englewood Hazardous drug handling system, apparatus and method
EP2554152A4 (fr) 2010-03-30 2015-09-23 Terumo Corp Connecteur et ensemble connecteur
EP2575734B1 (fr) 2010-05-27 2017-04-19 J&J Solutions, Inc. Système fermé de transfert de fluide
JP5804675B2 (ja) 2010-05-27 2015-11-04 日本コヴィディエン株式会社 コネクター用キャップ及びこれを備えた輸液ラインの接続装置
EP2765972B1 (fr) * 2011-10-14 2016-01-13 Novo Nordisk Health Care AG Agencement de transfert de fluide préassemblé
US9510997B2 (en) 2013-02-07 2016-12-06 Equashield Medical Ltd. Closed drug transfer system
JP2017513613A (ja) 2014-04-21 2017-06-01 ベクトン ディキンソン アンド カンパニー リミテッド 流体の閉じた移送のためのシステム
BR112016024683B1 (pt) 2014-04-21 2021-12-21 Becton Dickinson and Company Limited Adaptador de seringa com desengate de movimento composto e método

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EP3498251A4 (fr) 2020-03-04
JPWO2018030481A1 (ja) 2019-06-13
JP7151481B2 (ja) 2022-10-12
AU2017308385A1 (en) 2019-03-21
EP3498251B1 (fr) 2021-04-07
AU2017308385B2 (en) 2021-12-02
WO2018030481A1 (fr) 2018-02-15

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