WO2023095425A1 - バイアルアダプタ - Google Patents

バイアルアダプタ Download PDF

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Publication number
WO2023095425A1
WO2023095425A1 PCT/JP2022/034475 JP2022034475W WO2023095425A1 WO 2023095425 A1 WO2023095425 A1 WO 2023095425A1 JP 2022034475 W JP2022034475 W JP 2022034475W WO 2023095425 A1 WO2023095425 A1 WO 2023095425A1
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WO
WIPO (PCT)
Prior art keywords
vial
flow path
gas flow
vial adapter
gas
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.)
Ceased
Application number
PCT/JP2022/034475
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English (en)
French (fr)
Japanese (ja)
Inventor
佑 栗山
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.)
Terumo Corp
Original Assignee
Terumo Corp
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Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Priority to JP2023563527A priority Critical patent/JPWO2023095425A1/ja
Publication of WO2023095425A1 publication Critical patent/WO2023095425A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe

Definitions

  • the present disclosure relates to vial adapters.
  • vials have been used as containers for compounding drugs or containers for containing liquid medicines. Extraction of the drug solution from the inside of the vial and supply of a liquid such as a diluent into the vial are sometimes performed via a vial adapter attached to the vial.
  • Patent Literature 1 describes this type of vial adapter.
  • the vial adapter described in Patent Document 1 includes a puncture needle with a sharp tip and a female connector.
  • the puncture needle of Patent Document 1 is provided with a liquid channel and a gas channel extending along the longitudinal direction of the puncture needle.
  • the liquid channel of Patent Document 1 communicates with the female connector.
  • the gas flow path of Patent Literature 1 communicates with a vent that opens toward the outside.
  • the gas is allowed to flow from the vent to the gas channel on the gas communication path that communicates the gas channel in the puncture needle and the vent, and the gas is allowed to flow from the gas channel to the vent.
  • a one-way valve is provided that prohibits gas from flowing to.
  • a one-way valve as a check valve prohibits gas from flowing from the gas flow path to the vent.
  • the one-way valve may be deformed so that the gas flows from the gas flow path to the vent.
  • An object of the present disclosure is to provide a vial adapter capable of suppressing malfunction of a check valve.
  • a vial adapter is a vial adapter attachable to a vial, comprising a liquid channel capable of discharging liquid in the vial and an inlet, and introducing gas into the vial. an inhalable gas flow path; a check valve arranged in the gas flow path to restrict the gas in the vial from being discharged from the suction port; and an operation regulating unit that regulates malfunction of the check valve when pressure in a gas discharge direction toward the suction port reaches a predetermined pressure or higher.
  • the check valve is a duckbill valve that includes a deformed plate portion, and the operation regulating portion abuts against the deformed plate portion of the duckbill valve so as to press the deformed plate portion of the duckbill valve. It is a deformation restricting portion that restricts the inside-out deformation of the portion.
  • the deformation restricting portion is a rod-shaped portion extending within the gas flow path and having one end disposed on the back side of the deformation plate portion of the duckbill valve.
  • the deformation restricting portion does not contact the deformation plate portion of the duckbill valve when the pressure in the gas flow path in the discharge direction is less than the predetermined pressure, When the pressure in the gas flow path in the discharge direction is equal to or higher than the predetermined pressure, the deformed plate portion of the duckbill valve abuts.
  • a hydrophobic filter is provided in the gas flow path and through which gas can flow but liquid cannot pass.
  • the gas flow path includes a volume-varying section defining a variable space whose volume can be varied, and the volume-varying section is deformable according to the pressure in the gas flow path.
  • a deformation membrane is provided.
  • the volume changing section includes a membrane fixing section to which the deformable membrane is fixed and partitions the variable space between itself and the deformable membrane, and the suction port includes the membrane fixing section. , and the check valve and the operation restricting portion are arranged at the suction port.
  • FIG. 4 is a cross-sectional view showing a vial adapter attached to a vial according to an embodiment of the present disclosure
  • FIG. 3 is an explanatory view showing details of a check valve and an operation restricting portion of the vial adapter shown in FIG. 1
  • 3A and 3B are diagrams for explaining operations of a check valve and an operation restricting unit shown in FIG. 2
  • FIG. 3A and 3B are diagrams for explaining operations of a check valve and an operation restricting unit shown in FIG. 2
  • FIG. 3A and 3B are diagrams for explaining operations of a check valve and an operation restricting unit shown in FIG. 2
  • FIG. 1 is a perspective view of a vial adapter according to one embodiment of the present disclosure
  • FIG. 5 is a diagram showing an example of use of the vial adapter shown in FIG. 4;
  • FIG. 7 is a cross-sectional view of the vial adapter shown in FIG. 4 taken along line I-I in FIG. 6;
  • 5 is an exploded perspective view of the vial adapter shown in FIG. 4;
  • FIG. 9 is an exploded perspective view further disassembling a part of the vial adapter shown in FIG. 8;
  • 8 is an enlarged view showing the vicinity of a check valve and an operation restricting portion in FIG. 7;
  • FIG. FIG. 5 is a diagram showing an example of use of the vial adapter shown in FIG. 4;
  • FIG. 5 is a diagram showing an example of use of the vial adapter shown in FIG. 4;
  • FIG. 5 is a diagram showing an example of use of the vial adapter shown in FIG. 4; 5 is a view showing a modification of the vial adapter shown in FIG. 4; FIG. FIG. 5 is a perspective view showing an example of a medical connector that can be connected to the connecting portion of the vial adapter shown in FIG. 4; 14B is a perspective view of the medical connector shown in FIG. 14A from a different perspective than FIG. 14A; FIG.
  • FIG. 1 is a cross-sectional view of a vial adapter 10 as one embodiment of a vial adapter according to the present disclosure.
  • FIG. 1 shows the vial adapter 10 attached to the vial 200 .
  • the vial adapter 10 is attached to a vial 200 and used.
  • the vial adapter 10 is used, for example, when injecting liquid into the vial 200 .
  • the vial adapter 10 is used, for example, when extracting liquid from inside the vial 200 .
  • Injection of a liquid into the vial 200 is performed, for example, when injecting a liquid such as physiological saline into the vial 200 in order to dilute a powdered drug contained in the vial 200 .
  • a liquid is injected into the vial 200 through the vial adapter 10 from, for example, a syringe 81 (see FIGS. 11 and 12) connected to the vial adapter 10 .
  • Extraction of the liquid from the vial 200 is performed, for example, when extracting the drug solution stored in the vial 200 for use.
  • the liquid is extracted from the vial 200 through the vial adapter 10 using, for example, a syringe 81 (see FIGS. 11 and 12) connected to the vial adapter 10 .
  • 11 and 12 show a state in which the vial 200 contains a liquid X such as a chemical solution.
  • the usage of the vial adapter 10 is not limited to the usage example described above.
  • the vial adapter 10 includes a liquid channel 11 and a gas channel 12.
  • the liquid flow path 11 is a flow path capable of supplying liquid into the vial 200 from the outside.
  • the liquid channel 11 is a channel through which the liquid X in the vial 200 can be discharged.
  • the gas flow path 12 has an inlet 12a.
  • the gas channel 12 is a channel through which gas such as outside air can be sucked into the vial 200 .
  • a check valve 13 is arranged in the gas flow path 12 .
  • the check valve 13 allows ventilation in the suction direction B from the suction port 12 a into the vial 200 . That is, outside air can be taken into the vial 200 from the suction port 12a. Therefore, even if the liquid in the vial 200 is extracted through the liquid flow path 11 by the extractor 80 (see FIG. 12) such as a syringe 81 (see FIGS. 11 and 12), outside air may enter the vial 200 through the suction port 12a. Since the liquid is taken in, the inside of the vial 200 can be prevented from becoming negative pressure, and the normal pressure can be maintained.
  • the check valve 13 regulates the gas in the vial 200 from being discharged from the suction port 12 a of the gas flow path 12 .
  • the gas inside the vial 200 may contain substances that are harmful to the human body, for example, volatilized from the chemical solution. Therefore, the check valve 13 arranged in the gas flow path 12 can suppress the release of the gas in the vial 200 to the outside through the gas flow path 12 .
  • the vial adapter 10 further includes an operation restricting section 14 .
  • FIG. 2 is a diagram showing the details of the check valve 13 and the operation restricting section 14. As shown in FIG.
  • the operation restricting part 14 restricts malfunction of the check valve 13 in the gas flow path 12 under predetermined conditions.
  • the operation restricting unit 14 restricts the malfunction of the check valve 13 when the pressure in the discharge direction A of the gas from the inside of the vial 200 toward the suction port 12a reaches a predetermined pressure or higher.
  • the malfunction of the check valve 13 means an operation in which the check valve 13 does not function normally as a one-way valve that allows the flow of gas in the suction direction B in the gas flow path 12 . In other words, it means that the check valve 13 allows the gas to flow in the discharge direction A.
  • the check valve 13 of this embodiment is a duckbill valve having a deformed plate portion 24a.
  • the operation restricting portion 14 of the present embodiment is a deformation restricting portion that abuts against the deformed plate portion 24a of the duckbill valve as the check valve 13 and restricts the inside-out deformation of the deformed plate portion 24a.
  • the deformation restricting portion as the operation restricting portion 14 of the present embodiment extends within the gas flow path 12, and one end of the deforming plate portion 24a of the duckbill valve serving as the check valve 13 (suction port 12a side).
  • One end of the bar-shaped portion 15 abuts against the deformation plate portion 24a, thereby suppressing deformation of the deformation plate portion 24a inside out toward the suction port 12a. Details of this will be described later (see FIGS. 3A-3C).
  • a pressure higher than expected may be applied in the discharge direction A. In such a case, there is concern that the check valve 13 may malfunction.
  • the operation restricting portion 14 it is possible to restrict the malfunction of the check valve 13 even if a pressure higher than expected is applied in the gas flow path 12 in the discharge direction A. This can prevent the gas in the vial 200 from being discharged through the gas flow path 12 .
  • a vial adapter 10 of this embodiment includes an adapter body 2 , a valve member 3 and a cap member 4 .
  • the adapter main body 2 includes a puncture section 5 and a main body section 6.
  • the puncture part 5 is a puncture needle capable of puncturing a stopper 201 that closes the opening 200a of the vial 200.
  • the vial adapter 10 is attached to the vial 200 with the puncture part 5 piercing the stopper 201 . That is, as shown in FIG. 1 , in the vial adapter 10 attached to the vial 200 , the tip of the puncture part 5 passes through the plug 201 and reaches the inside of the vial 200 .
  • a first opening 5a and a second opening 5b are formed at the distal end of the puncture part 5. As shown in FIG. 1 , the first opening 5 a and the second opening 5 b are positioned within the vial 200 when the vial adapter 10 is attached to the vial 200 .
  • the body part 6 is connected to the puncture part 5 .
  • the body portion 6 includes a connection portion 7 having a connection port 7a.
  • an extractor 80 such as a syringe 81 (see FIGS. 11 and 12) capable of extracting the liquid in the vial 200 .
  • an intake port 12 a of the gas flow path 12 is formed in the body portion 6 .
  • the body portion 6 of the present embodiment includes a first tubular opening portion 6a and a second tubular opening portion 6b that protrude outward.
  • the connection portion 7 of the present embodiment is configured by the first cylindrical opening portion 6a.
  • the connection port 7a of this embodiment is comprised by the opening end of the 1st opening cylinder part 6a.
  • the suction port 12a of this embodiment is configured by the open end of the second cylindrical opening portion 6b.
  • the body portion 6 of the present embodiment includes a cylindrical mounting portion 8 that surrounds the puncture portion 5 and is mounted on the head portion 202 of the vial 200 .
  • an engaging claw 8a is formed to fit into the position of the neck portion 203 positioned between the head portion 202 and the body portion 204 of the vial 200. As shown in FIG.
  • the liquid flow path 11 extends from the puncture portion 5 to the connection port 7a of the connection portion 7 of the body portion 6. More specifically, the liquid flow path 11 extends from the first opening 5a of the puncture portion 5 to the connection port 7a of the connection portion 7 of the body portion 6 . Therefore, by connecting an injection tool 82 (see FIG. 11) such as a syringe 81 (see FIGS. 11 and 12) to the connecting portion 7, for example, the liquid in the injection tool 82 (see FIG. 11) can be transferred to the liquid channel. 11 into the vial 200 . Further, by connecting an extraction tool 80 (see FIG.
  • a liquid such as a drug solution in the vial 200 can be extracted from the vial 200 through the liquid flow path 11.
  • Syringe 81 is both injection tool 82 and extraction tool 80 .
  • the gas flow path 12 extends from the puncture portion 5 to the suction port 12a of the main body portion 6. More specifically, the gas flow path 12 extends from the second opening 5b of the puncture portion 5 to the suction port 12a of the body portion 6. As shown in FIG. Therefore, when an extraction tool 80 (see FIG. 12) such as a syringe 81 (see FIGS. 11 and 12) is connected to the connecting portion 7 to extract the liquid in the vial 200, the pressure inside the vial 200 should not be negative. In addition, outside air can be taken into the vial 200 through the gas flow path 12 .
  • an extraction tool 80 see FIG. 12
  • a syringe 81 see FIGS. 11 and 12
  • liquid channel 11 and the gas channel 12 of this embodiment are formed by the puncture portion 5 and the body portion 6 of the adapter body 2 .
  • Examples of the constituent material of the adapter body 2 of the present embodiment include polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymer; ethylene-vinyl acetate copolymer (EVA); polyvinyl chloride; polyvinylidene chloride; Polyamide; polyimide; polyamideimide; polycarbonate; poly-(4-methylpentene-1); ionomer; acrylic resin; resin); butadiene-styrene copolymer; polyester such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polycyclohexane terephthalate (PCT); polyether; polyether ketone (PEK); polyether ether ketone (PEEK) Polyetherimide; Polyacetal (POM); Polyphenylene oxide; Modified polyphenylene oxide; Polysulfone; Polyether sulfone; Polyphenylene sulfide; Various resin materials such as resin
  • valve member 3 is arranged at an inlet 12a of the gas flow path 12 formed in the body portion 6 of the adapter body 2. As shown in FIG.
  • the valve member 3 of this embodiment constitutes a duckbill valve as the check valve 13 of the vial adapter 10 .
  • the valve member 3 of this embodiment includes a valve body portion 21 and a fixing portion 22 .
  • the valve main body portion 21 includes a tubular portion 23 and a valve portion 24 that continues to the tip that is one axial end of the tubular portion 23 .
  • the fixed portion 22 continues to the proximal end, which is the other end in the axial direction, of the cylindrical portion 23 of the valve body portion 21 .
  • the axial direction of the cylindrical portion 23 from the base end side to the tip end side may be simply referred to as "the tip direction C”.
  • the direction from the distal side to the proximal side in the axial direction of the cylindrical portion 23 may be simply referred to as "the proximal direction D".
  • the valve portion 24 of the valve main body portion 21 includes two deformable plate portions 24a that are inclined toward each other from the base end connected to the tip of the cylindrical portion 23 toward the tip end direction C.
  • the deformation plate portion 24 a is an inclined plate portion that extends obliquely with respect to the axial direction of the tubular portion 23 .
  • the tip portions of the two deformation plate portions 24a are in contact with each other to form a slit 25 therebetween.
  • valve portion 24 includes a connection plate portion 24b located between the two deformation plate portions 24a in the circumferential direction of the cylindrical portion 23.
  • the connection plate portion 24b is a curved plate portion that is formed by extending the cylindrical portion 23 and that curves in an arc shape.
  • the two deformation plate portions 24a are connected by two connection plate portions 24b located on both sides of the cylinder portion 23 in the circumferential direction.
  • the slit 25 formed by the distal ends of the two deformation plate portions 24a is closed at both ends in the slit longitudinal direction.
  • the distal end portions of the two deformable plate portions 24a are in a state of being in contact with each other in the slit width direction in a natural state (a state in which no external force is applied). That is, the slit 25 is closed.
  • the slits 25 are opened by deforming the center portions of the distal ends of the two deformation plate portions 24a in the longitudinal direction of the slits so as to separate from each other in the width direction of the slits.
  • the slit 25 is formed by the entire distal end portions of the two deformable plate portions 24a, but is not limited to this configuration, and may be formed by only a part of the distal end portions.
  • the valve member 3 is arranged in the gas flow path 12 so that the tip direction C is the suction direction B. More specifically, the valve member 3 of this embodiment is inserted from the suction port 12a of the gas flow path 12 formed in the body portion 6 of the adapter body 2 so that the tip end direction C is the suction direction B. It is attached to the main body 6 in this state. Therefore, when outside air flows into the gas passage 12 from the suction port 12a, the flowing gas presses the inner surfaces of the two deformable plate portions 24a in a direction to separate the two deformable plate portions 24a from each other. As a result, the slit 25 is opened, and the check valve 13 formed by the valve member 3 allows the gas in the suction direction B to flow.
  • the valve main body 21 of the present embodiment includes the cylindrical portion 23 and the valve portion 24, but is not limited to this configuration.
  • the valve body portion 21 may be configured to include only the valve portion 24 .
  • the valve portion 24 of the present embodiment includes two deformation plate portions 24a and two connection plate portions 24b, the configuration is not limited to this.
  • the valve portion 24 may include three or more deformation plate portions.
  • the connection plate portion of the valve portion 24 may be appropriately designed according to the number and shape of the deformation plate portions, and may be configured without the connection plate portion.
  • the fixed portion 22 protrudes radially outward of the tubular portion 23 from the proximal end of the tubular portion 23 of the valve body portion 21 . That is, the fixing portion 22 of this embodiment is an annular flange projecting from the proximal end of the tubular portion 23 . In the valve member 3 of the present embodiment, the fixing portion 22 is sandwiched between the opening end of the second opening cylindrical portion 6b of the main body portion 6 of the adapter main body 2 and the cap member 4 to seal the space therebetween. state and is fixed.
  • the check valve 13 configured by the valve member 3 of this embodiment is arranged at the suction port 12a, but may be arranged at a different position within the gas flow path 12. However, as in this embodiment, when the check valve 13 is configured as a separate member from the adapter main body 2 forming the gas flow path 12, maintenance such as inspection and replacement and attachment at the time of installation are easy. From the point of view, it is preferable to dispose at the suction port 12a.
  • valve member 3 of the present embodiment examples include synthetic rubbers such as polybutadiene, nitrile, and chloroprene; natural rubbers such as polyisoprene; and thermosetting elastomers such as urethane rubber, silicone rubber, and fluororubber. , thermoplastic elastomers, or other elastomers.
  • the cap member 4 of the present embodiment is fixed to the body portion 6 of the adapter body 2 in a state in which the fixing portion 22 of the valve member 3 is sandwiched between the body portion 6 and the body portion 6 of the adapter body 2.
  • the cap member 4 of the present embodiment includes a bar-shaped portion 15 as an operation restricting portion 14 of the vial adapter 10 .
  • the cap member 4 of this embodiment includes a fixing portion 31 and a rod portion 15 .
  • the fixing part 31 is not particularly limited as long as it is configured to be fixed to the main body part 6 of the adapter main body 2 .
  • the fixing portion 31 of this embodiment includes a tubular portion 32 and a bottom plate portion 33 .
  • the tubular portion 32 is fitted onto the second opening tubular portion 6 b of the body portion 6 .
  • a pawl portion 32a is formed on the inner surface of the cylindrical portion 32 so as to get over the locking protrusion 6b1 formed on the outer surface of the second opening cylindrical portion 6b of the main body portion 6 and to be hooked.
  • the bottom plate portion 33 continues to one axial end of the tubular portion 32 .
  • the bottom plate portion 33 fixes the valve member 3 between the bottom plate portion 33 and the opening end of the second opening cylinder portion 6b in a state in which the claw portion 32a of the cylinder portion 32 rides over the locking projection portion 6b1 of the second opening cylinder portion 6b.
  • An annular flange as part 22 is sandwiched.
  • the cap member 4 of the present embodiment is fixed to the body portion 6 with the fixing portion 22 of the valve member 3 sandwiched between the cap member 4 and the body portion 6 .
  • the bottom plate portion 33 covers the open end of the second tubular opening portion 6b that constitutes the suction port 12a.
  • the bottom plate portion 33 is formed with one or more (four in this embodiment) through holes 33a. Therefore, the intake port 12a can inhale outside air through the through hole 33a.
  • the rod-shaped portion 15 extends in the gas flow path 12 and one end is arranged on the back side of the deformed plate portion 24 a of the duckbill valve as the check valve 13 .
  • the rod-shaped portion 15 is not particularly limited as long as the tip, which is one end thereof, is arranged near the inner surface of the deformable plate portion 24a.
  • the rod-shaped portion 15 of this embodiment protrudes from the bottom plate portion 33 toward the inside of the cylindrical portion 32 .
  • Constituent materials of the cap member 4 of the present embodiment include, for example, the materials listed above as constituent materials of the adapter main body 2 .
  • the vial adapter 10 of this embodiment is composed of three members, the adapter body 2, the valve member 3, and the cap member 4, but is not limited to this configuration.
  • the vial adapter 10 may be composed of, for example, only one member having the functions of the adapter main body 2, the valve member 3 and the cap member 4. Also, the vial adapter 10 may realize the functions of the adapter main body 2, the valve member 3, and the cap member 4 by two or four or more members. In other words, the number of members constituting the vial adapter 10 is not particularly limited.
  • FIG. 3A is a diagram for explaining the operation of the check valve 13 when gas pressure acts on the check valve 13 from the suction direction B.
  • FIG. 3A is a diagram for explaining the operation of the check valve 13 when gas is sucked into the vial 200 from the suction port 12a.
  • the two deformation plate portions 24a are pressed apart from each other by the gas flowing in from the suction port 12a.
  • the two deformable plate portions 24a are deformed so as to separate from each other, allowing gas to flow into the vial 200 from the suction port 12a.
  • the rod-shaped portion 15 as the motion restricting portion 14 does not restrict the motion of the deformation plate portion 24a.
  • FIGS. 3B and 3C are diagrams for explaining the operation of the check valve 13 when gas pressure acts on the check valve 13 from the discharge direction A.
  • FIG. 3B and 3C are diagrams for explaining the operation of the check valve 13 when pressure acts on the check valve 13 to discharge gas from the vial 200 through the suction port 12a.
  • FIG. 3B shows the case where the pressure of the gas in the discharge direction A acting on the check valve 13 is less than the predetermined pressure.
  • FIG. 3C shows a case where the gas pressure in the discharge direction A acting on the check valve 13 is equal to or higher than a predetermined pressure.
  • the "predetermined pressure” referred to here means the maximum pressure at which the check valve 13 normally operates as a one-way valve.
  • the two deformation plate portions 24a are pressed toward each other by the gas from the vial 200.
  • the slit 25 formed by the distal ends of the two deformable plate portions 24a remains closed.
  • the check valve 13 operates normally to regulate the discharge of gas from the vial 200 toward the suction port 12a.
  • the rod-shaped portion 15 as the motion restricting portion 14 does not restrict the motion of the deformation plate portion 24a.
  • the tip portions of the two deformation plate portions 24a It may be transformed to turn inside out. In such cases, the slit 25 may unintentionally open.
  • the rod-shaped portion 15 as the movement restricting portion 14 restricts the above-described turning over deformation of the two deformation plate portions 24a. Specifically, when the deformable plate portion 24a attempts to deform so as to turn inside out, the distal end portion of the bar-shaped portion 15 abuts against the inner surface of the deformable plate portion 24a. As a result, even if a pressure equal to or higher than the predetermined pressure acts on the check valve 13 in the discharge direction A, the opening of the slit 25 can be suppressed. Therefore, malfunction of the check valve 13 can be prevented.
  • the operation restricting portion 14 of the present embodiment is a deformation restricting portion that restricts deformation of the deformed plate portion 24a of the duckbill valve as the check valve 13, but is not limited to this configuration.
  • the operation restricting portion 14 may be appropriately designed to restrict malfunction according to the configuration of the check valve 13 .
  • the deformation restricting portion as the motion restricting portion 14 of the present embodiment is the bar-shaped portion 15, the shape of the deformation restricting portion is not particularly limited.
  • the shape of the deformation restricting portion as the motion restricting portion 14 may be appropriately designed according to the configuration of the check valve 13 .
  • the check valve 13 be a duckbill valve with a simple configuration. Therefore, it is preferable that the operation restricting portion 14 also be a deformation restricting portion that restricts abnormal deformation of the deformable plate portion 24a of the duckbill valve. Furthermore, since the duckbill valve as the check valve 13 is arranged in the gas flow path 12, the deformation regulating section as the operation regulating section 14 is a rod-shaped portion like this embodiment, which can be easily arranged in the gas flow path 12. 15 is preferred.
  • the deformation restricting portion as the operation restricting portion 14 is a deformed plate portion of the duckbill valve as the check valve 13 when the pressure in the discharge direction A in the gas flow path 12 is less than the predetermined pressure (see FIG. 3B). It is preferred not to abut 24a.
  • the deformation restricting portion as the operation restricting portion 14 is a deformed plate portion of the duckbill valve as the check valve 13. 24a is preferred. By doing so, it is possible to prevent the normal operation of the duckbill valve as the check valve 13 from being unintentionally hindered by the deformation restricting portion as the operation restricting portion 14 when the pressure is less than the predetermined pressure.
  • FIG. 4 and 5 are perspective views of the vial adapter 100 viewed from different viewpoints.
  • FIG. 6 is a top view of the vial adapter 100.
  • FIG. 7 is a cross-sectional view of vial adapter 100 taken along line II in FIG.
  • FIG. 8 is an exploded perspective view of the vial adapter 100.
  • FIG. 9 is an exploded perspective view in which a portion of the vial adapter 100 shown in FIG. 8 is further exploded.
  • FIG. 10 is an enlarged view showing the vicinity of the check valve 13 and the operation restricting portion 14 in FIG. FIG.
  • FIG. 11 shows an example of use in which liquid X is injected into vial 200 through vial adapter 100.
  • FIG. 12 shows an example of use in which the liquid X in the vial 200 is extracted through the vial adapter 100.
  • FIG. 12 shows an example of use in which the liquid X in the vial 200 is extracted through the vial adapter 100.
  • the vial adapter 10 includes a liquid channel 11 and a gas channel 12.
  • the liquid channel 11 is a channel capable of supplying the liquid X into the vial 200 from the outside.
  • the liquid channel 11 is a channel through which the liquid X in the vial 200 can be discharged.
  • the gas flow path 12 has an inlet 12a.
  • the gas channel 12 is a channel through which gas such as outside air can be sucked into the vial 200 .
  • a check valve 13 is arranged in the gas flow path 12 .
  • the check valve 13 allows ventilation in the suction direction B from the suction port 12 a into the vial 200 . That is, outside air can be taken into the vial 200 from the suction port 12a. Therefore, as shown in FIG. 12, even if the liquid X in the vial 200 is extracted through the liquid flow path 11 by the extractor 80 such as the syringe 81, outside air is taken into the vial 200 through the suction port 12a. It is possible to suppress the inside of 200 from becoming a negative pressure. However, as shown in FIG. 11, when the volume varying portion 12b, which will be described later, contains gas, the gas stored in the volume varying portion 12b enters the vial 200 without taking in outside air from the suction port 12a. You may move.
  • the check valve 13 regulates the gas in the vial 200 (see FIGS. 11 and 12) from being discharged from the suction port 12a of the gas flow path 12.
  • the gas inside the vial 200 may contain substances that are harmful to the human body, for example volatilized from the chemical solution. Therefore, the check valve 13 arranged in the gas flow path 12 can suppress the release of the gas in the vial 200 to the outside through the gas flow path 12 .
  • the vial adapter 100 further includes an operation restricting section 14 .
  • the check valve 13 and the operation restricting portion 14 of the present embodiment have the same configuration as the vial adapter 10 described above, and thus description thereof is omitted here.
  • the vial adapter 100 of the present embodiment mainly has the presence or absence of the volume variation portion 12b of the gas flow path 12 and the hydrophobic filter 43.
  • the configuration is different depending on the presence or absence of
  • the gas flow path 12 of this embodiment includes a volume variation portion 12b.
  • the volume variation section 12b defines a variable space 12b1 whose volume can be varied. Therefore, as shown in FIG. 11, the gas in the vial 200 can be accommodated in the variable space 12b1 of the volume variable section 12b. By doing so, it is possible to suppress the gas inside the vial 200 from being released to the outside, and it is possible to suppress the inside of the vial 200 from becoming a positive pressure.
  • the volume variation section 12b of this embodiment includes a deformable membrane 41 that can be deformed according to the pressure inside the gas flow path 12.
  • the deformable membrane 41 deforms so that the volume of the variable space 12b1 increases when the pressure in the gas flow path 12 increases. Further, the deformable membrane 41 deforms so that the volume of the variable space 12b1 decreases when the pressure in the gas flow path 12 decreases.
  • the volume varying portion 12b can be formed with a simple configuration.
  • the volume changing portion 12b of the present embodiment includes a film fixing portion 42 to which the deformable film 41 is fixed.
  • the film fixing portion 42 defines a variable space 12b1 between itself and the deformable film 41 .
  • a concave portion 42a is formed on the surface of the film fixing portion 42 of this embodiment.
  • the deformable membrane 41 extends along the concave portion 42a of the membrane fixing portion 42 in a natural state.
  • the outer edge of the deformable film 41 is joined to the edge of the concave portion 42a of the film fixing portion 42 by welding, bonding, or the like.
  • the deformable film 41 when gas flows between the deformable film 41 and the recess 42a of the film fixing portion 42, the deformable film 41 swells away from the recess 42a of the film fixing portion 42, as shown in FIG. Increase the volume of the variable space 12b1.
  • the suction port 12 a of the gas flow path 12 of this embodiment is formed in the membrane fixing portion 42 .
  • a through hole 42b is formed in the membrane fixing portion 42, one end of which communicates with the variable space 12b1 and the other end of which communicates with the outside.
  • the suction port 12a of the gas flow path 12 of this embodiment is configured by this through hole 42b.
  • the check valve 13 and the operation restricting portion 14 are arranged in the suction port 12 a formed in the membrane fixing portion 42 . Therefore, the volume variation portion 12 b is positioned in the suction direction B of the gas flow path 12 with respect to the check valve 13 .
  • the gas flowing from the vial 200 toward the suction port 12 a flows into the volume variation portion 12 b before reaching the check valve 13 .
  • a groove portion 42a1 is formed in the concave portion 42a of the film fixing portion 42.
  • the through hole 42b of the membrane fixing portion 42 which constitutes the suction port 12a, communicates with the variable space 12b1 on the inner surface of the groove portion 42a1.
  • a portion of the gas flow path 12 extending from the vial 200 to the variable space 12b1 also communicates with the variable space 12b1 on the inner surface of the groove portion 42a1.
  • the volume of the variable space 12b1 does not become zero due to the groove 42a1, and the gas flow path 12 from the inlet 12a to the inside of the vial 200 is It is maintained by the groove portion 42a1 of the recess portion 42a.
  • the vial adapter 100 of this embodiment includes a hydrophobic filter 43 arranged inside the gas flow path 12 .
  • the hydrophobic filter 43 is configured to allow gas to flow but not to allow liquid to flow.
  • the liquid X see FIGS. 11 and 12
  • the gas flow path 12 of the vial adapter 10 of this embodiment includes the above-described volume variation portion 12b.
  • the hydrophobic filter 43 is preferably positioned in the suction direction B from the volume varying portion 12b in the gas flow path 12. As shown in FIG. By doing so, even if the liquid X in the vial 200 flows into the gas flow path 12, it can be suppressed from reaching the volume variation portion 12b.
  • the vial adapter 100 of this embodiment includes an adapter body 2, a valve member 3, a cap member 4, a filter member 61, and a volume change member 62. Since the valve member 3 and the cap member 4 are the same as those of the vial adapter 10 described above, their description is omitted here.
  • the adapter body 2 of this embodiment includes a puncture section 5 and a body section 6 .
  • the puncture part 5 is a puncture needle capable of puncturing the stopper 201 that closes the opening 200a of the vial 200.
  • the puncture unit 5 has the same configuration as the vial adapter 10 described above, the description thereof is omitted here.
  • the body part 6 is connected to the puncture part 5 .
  • the body portion 6 includes a connection portion 7 having a connection port 7a.
  • the connecting portion 7 is connected with an extractor 80 such as a syringe 81 capable of extracting the liquid X in the vial 200 .
  • the connecting part 7 may be connected to an injection tool 82 such as a syringe 81 capable of injecting the liquid X into the vial 200 .
  • the body portion 6 includes a connection portion 50 having a connection port 50a. The connection portion 50 is connected to the volume variation member 62 with the filter member 61 sandwiched therebetween.
  • the connecting portion 7 is hereinafter referred to as the "first connecting portion 7", and the connecting portion 50 is referred to as the "second connecting portion 50". Further, the connection port 7a of the first connection portion 7 is described as “first connection port 7a”, and the connection port 50a of the second connection portion 50 is described as “second connection port 50a”.
  • the body portion 6 of the present embodiment includes a cylindrical mounting portion 8 that surrounds the puncture portion 5 and is mounted on the head portion 202 of the vial 200 .
  • the inner surface of the cylindrical mounting portion 8 of this embodiment is not formed with a locking claw that fits into the position of the neck portion 203 positioned between the head portion 202 and the body portion 204 of the vial 200.
  • a locking claw 8a may be formed.
  • the constituent material of the adapter body 2 of this embodiment for example, the same material as that of the adapter body 2 of the vial adapter 10 described above can be used.
  • the filter member 61 constitutes the hydrophobic filter 43 . As shown in FIGS. 7 and 8 , the filter member 61 is configured so that the second connection portion 50 of the main body portion 6 of the adapter main body 2 and the volume variation member 62 are connected to each other. 6 and a connection hole 42c of the volume varying member 62, which will be described later.
  • the filter member 61 may be, for example, a membrane whose surface is hydrophobized or a hydrophobic membrane.
  • materials constituting such hydrophobic membranes include polypropylene, polyethylene, polyester, polysulfone, polyacrylonitrile, and polytetrafluoroethylene.
  • the filter member 61 is preferably made porous by stretching, microphase separation, electron beam etching, sintering, argon plasma particles, or the like.
  • the method of the hydrophobization treatment is not particularly limited, and for example, the filter member 61 may be coated with a constituent material having hydrophobic properties on its surface.
  • the volume-varying member 62 constitutes the volume-varying portion 12 b of the gas flow path 12 .
  • the volume varying member 62 includes a bowl-shaped body 71 and a membrane body 72 .
  • the deformable film 41 of the volume changing portion 12b of the present embodiment described above is composed of a film body 72.
  • the film fixing portion 42 of the volume changing portion 12b of the present embodiment described above is configured by the bowl-shaped body 71. As shown in FIG.
  • the bowl-shaped body 71 includes a bowl-shaped body portion 71a and an opening cylindrical portion 71b projecting outward from the bottom of the bowl-shaped body portion 71a.
  • the through hole 42b of the membrane fixing portion 42 of the volume varying portion 12b described above is formed by a hole extending from the inner surface of the bowl-shaped main body portion 71a of the bowl-shaped body 71 to the open end of the open cylindrical portion 71b. . That is, the suction port 12a of the gas flow path 12 of this embodiment is formed by the open end of the open cylindrical portion 71b of the bowl-shaped body 71.
  • the valve member 3 and the cap member 4 of this embodiment are attached to the opening cylinder portion 71b.
  • the configuration for attaching the valve member 3 and the cap member 4 to the opening cylinder portion 71b is as follows. Since it is the same as the mounting configuration, the description is omitted here.
  • the bowl-shaped main body portion 71a is formed with a connection hole 42c in addition to the through hole 42b described above.
  • the bowl-shaped main body portion 71a is connected to the main body portion 6 of the adapter main body 2 in such a manner that the connection hole 42c and the second connection port 50a of the main body portion 6 of the adapter main body 2 are ventilated via the filter member 61 .
  • the groove portion 42 a 1 of the present embodiment described above is formed in the concave portion of the bowl-shaped body portion 71 a of the bowl-shaped body 71 .
  • the through hole 42b and the connection hole 42c communicate with the variable space 12b1 on the inner surface of the groove portion 42a1.
  • the outer edge portion of the film body 72 is joined to the edge portion of the bowl-shaped body portion 71a of the bowl-shaped body 71 by adhesion, welding, or the like.
  • the central portion surrounded by the outer edge portion of the film body 72 extends along the inner surface of the concave portion of the bowl-shaped main body portion 71a in a natural state.
  • a variable space 12b1 is defined between the inner surface of the concave portion of the bowl-shaped main body portion 71a of the bowl-shaped body 71 and the central portion of the film body 72. As shown in FIG.
  • the constituent material of the bowl-shaped body 71 is, for example, the same material as the adapter main body 2 of the vial adapter 10 described above.
  • the constituent material of the film body 72 is, for example, polyolefin such as polyethylene, polypropylene, ethylene-propylene copolymer; ethylene-vinyl acetate copolymer (EVA); polyvinyl chloride; polyvinylidene chloride; polystyrene; polyamide; imide; polycarbonate; poly-(4-methylpentene-1); ionomer; acrylic resin; polymethyl methacrylate; acrylonitrile-butadiene-styrene copolymer (ABS resin); Styrene copolymer; polyester such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polycyclohexane terephthalate (PCT); polyether; polyether ketone (PEK); polyether ether ketone (PEEK); polyacetal (POM); polyphenylene oxide; modified polyphenylene oxide; polysulfone; polyether sulfone; polypheny
  • the constituent materials of the film body 72 include, for example, natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, and ethylene-propylene rubber. , hydrin rubber, urethane rubber, silicone rubber, fluororubber, styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, transpolyisoprene, fluororubber , various thermoplastic elastomers such as chlorinated polyethylene.
  • the liquid flow path 11 of this embodiment extends from the puncture portion 5 to the first connection port 7a of the first connection portion 7 of the main body portion 6 . More specifically, the liquid flow path 11 extends from the first opening 5a of the puncture portion 5 to the first connection port 7a of the first connection portion 7 of the body portion 6 . Therefore, as shown in FIG. 11, by connecting an injection tool 82 such as a syringe 81 to the first connecting portion 7, for example, the liquid X in the injection tool 82 is injected into the vial 200 through the liquid flow path 11. can do. Further, as shown in FIG.
  • the gas flow path 12 of this embodiment extends from the puncture section 5 to the suction port 12a of the volume varying member 62.
  • the gas flow path 12 of the present embodiment extends from the second opening 5b of the puncture portion 5 to the second connection port 50a of the second connection portion 50 of the body portion 6, the filter member 61, and the volume variation member 62. It passes through the connection hole 42c (see FIG. 8, etc.), the variable space 12b1 of the volume varying member 62, and the through hole 42b of the volume varying member 62 in order, and extends to the suction port 12a. Therefore, as shown in FIG.
  • the liquid flow path 11 of this embodiment is formed by the puncture portion 5 and the body portion 6 of the adapter body 2 .
  • the gas flow path 12 of this embodiment is formed by the puncture portion 5 of the adapter body 2, the body portion 6, the filter member 61 and the volume variation member 62. As shown in FIG.
  • the vial adapter 100 of this embodiment is composed of five members, namely, the adapter body 2, the valve member 3, the cap member 4, the filter member 61, and the volume change member 62, but this configuration is limited. can't
  • the vial adapter 100 may be composed of, for example, only one member having the functions of the adapter main body 2, the valve member 3, the cap member 4, the filter member 61 and the volume changing member 62.
  • the vial adapter 100 may realize the functions of the adapter main body 2, the valve member 3, the cap member 4, the filter member 61 and the volume variation member 62 by two to four or six or more members. In other words, the number of members constituting vial adapter 100 is not particularly limited.
  • the vial adapter according to the present disclosure is not limited to the configuration specifically shown in the above-described embodiment, and various modifications, changes, and combinations are possible without departing from the scope of claims.
  • the volume varying portion 12b of the vial adapter 100 of the second embodiment may be applied to the vial adapter 10 of the first embodiment.
  • the hydrophobic filter 43 of the vial adapter 100 of the second embodiment may be applied to the vial adapter 10 of the first embodiment.
  • FIG. 13A and 13B are diagrams showing a modification of the vial adapter 100.
  • FIG. 13 is a cross-sectional view of a modification of vial adapter 100 at the same position as in FIG.
  • the suction port 12a is not formed in the membrane fixing portion 42, but is formed in the body portion 6 of the adapter body 2.
  • the suction port 12a shown in FIG. 13 is located in the suction direction B in the gas flow path 12 from the volume varying portion 12b.
  • the valve member 3 and the cap member 4 shown in FIG. 13 are attached to the opening cylinder portion 6c.
  • the configuration for attaching the valve member 3 and the cap member 4 to the opening cylinder portion 6c is such that the valve member 3 and the cap member 4 of the vial adapter 10 (see FIG. 1) are attached to the second opening cylinder portion 6b (see FIG. 1). Since it is the same as the mounting configuration, the description is omitted here.
  • the suction port 12a is formed in the body portion 6, so the bowl-shaped body 71 that constitutes the membrane fixing portion 42 does not have the opening cylindrical portion 71b. Further, in the vial adapter 100 shown in FIG. 13, since the suction port 12a is formed in the body portion 6, the membrane fixing portion 42 does not need to be provided with the groove portion 42a1 as shown in FIG.
  • FIGS. 14A and 14B show a medical connector as an example of a medical connector connectable to the connecting portion 7 of the vial adapter 10 of the first embodiment and the first connecting portion 7 of the vial adapter 100 of the second embodiment.
  • 300 is a diagram showing FIG.
  • a medical connector 300 shown in FIGS. 14A and 14B includes a luer lock type male connector portion 301 and a closed type female connector portion 302 .
  • the male connector portion 301 is inserted into the connection port 7a of the connection portion 7 of the vial adapter 10 of the first embodiment and the first connection port 7a of the first connection portion 7 of the vial adapter 100 of the second embodiment.
  • a male luer 303 is provided.
  • the male connector portion 301 includes a cylindrical portion 304 surrounding the male luer 303 .
  • a female screw portion that can be screwed into the male screw portion provided on the connection portion 7 of the vial adapter 10 of the first embodiment and the first connection portion 7 of the vial adapter 100 of the second embodiment. 304a is formed.
  • the female connector section 302 includes a cylindrical section 305 defining an insertion opening 305a into which a male luer having the same shape as the male luer 303 can be inserted, and an elastic valve body 306 having a slit 306a and closing the insertion opening 305a.
  • connection part 7 of the vial adapter 10 of the first embodiment and the first connecting part 7 of the vial adapter 100 of the second embodiment are connected to the injector or the extractor via the medical connector 300. may be connected.
  • connection portion 7 of the vial adapter 10 of the first embodiment and the first connection portion 7 of the vial adapter 100 of the second embodiment are connected by a closed female connector portion 302 including an elastic valve body 306, for example. may be configured.
  • the present disclosure relates to vial adapters.
  • Adapter main body 3 Valve member 4: Cap member 5: Puncture part 5a: First opening 5b: Second opening 6: Main body part 6a: First cylindrical opening part 6b: Second cylindrical opening part 6b1: Locking protrusion 6c: Opening cylindrical portion 7: First connection portion (connection portion) 7a: first connection port (connection port) 8: Mounting part 8a: Locking claws 10, 100: Vial adapter 11: Liquid channel 12: Gas channel 12a: Suction port 12b: Volume change part 12b1: Change space 13: Check valve 14: Operation regulation part 15: Rod-shaped part (deformation control part) 21: valve body 22: fixed portion 23: cylindrical portion 24: valve portion 24a: deformation plate portion 24b: connection plate portion 25: slit 31: fixed portion 32: cylindrical portion 32a: claw portion 33: bottom plate portion 33a: through hole 41: deformation film 42: film fixing portion 42a: concave portion 42a1: groove portion 42b: through hole 42c: connection hole 43: hydrophobic filter 50: second connection portion

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  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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  • Medical Preparation Storing Or Oral Administration Devices (AREA)
PCT/JP2022/034475 2021-11-25 2022-09-14 バイアルアダプタ Ceased WO2023095425A1 (ja)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6095281A (ja) * 1983-09-26 1985-05-28 ヴアーネイ・ラボラトリーズ・インコーポレーテツド 弁組立体
JP2016504155A (ja) * 2013-01-23 2016-02-12 アイシーユー メディカル インコーポレイテッドＩＣＵ Ｍｅｄｉｃａｌ，Ｉｎｃ． 医療用アダプタ及び圧力調節バイアルアダプタ

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6095281A (ja) * 1983-09-26 1985-05-28 ヴアーネイ・ラボラトリーズ・インコーポレーテツド 弁組立体
JP2016504155A (ja) * 2013-01-23 2016-02-12 アイシーユー メディカル インコーポレイテッドＩＣＵ Ｍｅｄｉｃａｌ，Ｉｎｃ． 医療用アダプタ及び圧力調節バイアルアダプタ

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