WO2024154420A1 - 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
WO2024154420A1
WO2024154420A1 PCT/JP2023/040630 JP2023040630W WO2024154420A1 WO 2024154420 A1 WO2024154420 A1 WO 2024154420A1 JP 2023040630 W JP2023040630 W JP 2023040630W WO 2024154420 A1 WO2024154420 A1 WO 2024154420A1
Authority
WO
WIPO (PCT)
Prior art keywords
flow path
vial
volume
gas
gas flow
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.)
Pending
Application number
PCT/JP2023/040630
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English (en)
French (fr)
Japanese (ja)
Inventor
広恵 川名
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
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 Terumo Corp filed Critical Terumo Corp
Priority to JP2024571629A priority Critical patent/JPWO2024154420A1/ja
Publication of WO2024154420A1 publication Critical patent/WO2024154420A1/ja
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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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

Definitions

  • This disclosure relates to a vial adapter.
  • a vial adapter has a fluid flow path capable of discharging liquid from within a vial, a gas flow path having a suction port and capable of sucking gas from the suction port into the vial, and a backflow suppression section disposed in the gas flow path that prevents gas from being discharged from the suction port, the gas flow path having a volume fluctuation section that forms a variable space whose volume can be varied (see, for example, FIG. 21 of Patent Document 1).
  • the variable space may not be able to contract sufficiently because gas is sucked into the vial from the suction port through the gas flow path.
  • an aspirating/discharging device such as a syringe
  • the capacity of the gas flow path is likely to be insufficient to return all the liquid to the vial.
  • the present disclosure therefore aims to provide a vial adapter that is less likely to have a shortage of gas flow path capacity to return all liquid to the vial.
  • a fluid flow path capable of discharging liquid from within the vial; a gas flow path having a suction port and capable of suctioning gas from the suction port into the vial;
  • the backflow suppression unit is disposed in the gas flow path and prevents the gas from being discharged from the suction port.
  • the volume varying portion includes a deformation membrane that is deformable in response to pressure in the gas flow path, and a membrane fixing portion to which the deformation membrane is fixed and that forms the fluctuation space between the deformation membrane and a membrane fixing portion,
  • the deformable membrane comes into contact with the inner surface of the membrane fixing portion when a predetermined volume of gas that is 1.3 times the maximum volume of the variable space is sucked from the gas flow path into the vial at a predetermined flow rate within a range of 0.1 to 10 cm3 /s that remains constant over time, from a most expanded state in which the volume of the variable space is at its maximum, in an unobstructed state in which suction from the suction port is not obstructed.
  • the membrane fixing portion has a bowl-shaped portion
  • the vial adapter according to any one of claims [1] to [3], wherein the deformable membrane, in the unobstructed state, contacts the inner surface of the bowl-shaped portion of the membrane fixing portion when the specified volume of gas is sucked from the gas flow path into the vial at the specified flow rate that becomes constant over time from the maximum expanded state.
  • the present disclosure provides a vial adapter that is less likely to run short of gas flow path capacity to return all liquid to the vial.
  • FIG. 1 is an external view of a vial adapter according to one embodiment.
  • 2 is an external view of an attachment body formed by attaching the vial adapter shown in FIG. 1 to a vial.
  • FIG. FIG. 3 is a cross-sectional view of the mounting body shown in FIG. 2 .
  • FIG. 3 is an explanatory diagram illustrating the operation of supplying liquid from a syringe to a vial through a vial adapter in the mounting body shown in FIG. 2, and then aspirating the mixed liquid obtained by mixing the liquid with the contents in the vial into the syringe through the vial adapter.
  • FIG. 1 is an external view of a vial adapter according to one embodiment.
  • 2 is an external view of an attachment body formed by attaching the vial adapter shown in FIG. 1 to a vial.
  • FIG. FIG. 3 is a cross-sectional view of the mounting body shown in FIG. 2 .
  • FIG. 3 is an explanatory diagram illustrating the operation of supplying
  • FIG. 3 is an explanatory diagram illustrating a measurement procedure for measuring a first suction force when gas equivalent to the maximum volume of the variable space from the most expanded state is sucked into the vial at a predetermined flow rate that remains constant over time when the suction port is blocked by an obstructing member in the attachment shown in FIG.
  • FIG. 3 is an explanatory diagram illustrating a measurement procedure for measuring a second suction force when gas equivalent to the maximum volume of the variable space in the most contracted state is sucked from the suction port into the vial at a predetermined flow rate that remains constant over time in the attachment shown in FIG.
  • a vial adapter 1 has a fluid flow path 3 capable of discharging liquid from within a vial 2, a gas flow path 4 having an suction port 4a and capable of sucking gas into the vial 2 from the suction port 4a, a backflow suppression section 5 disposed in the gas flow path 4 and restricting the gas from being discharged from the suction port 4a, and a volume fluctuation section 6 forming a variable space 4b in the gas flow path 4 whose volume can be varied.
  • the volume fluctuation section 6 has a deformation membrane 6a that can deform in response to the pressure within the gas flow path 4, and a membrane fixing section 6b to which the deformation membrane 6a is fixed and which forms the variable space 4b between the deformation membrane 6a and the membrane fixing section 6b.
  • the volume fluctuation section 6 and the backflow suppression section 5 can suppress the discharge of gas to the outside, which is effective when the contents generate harmful gas, such as when the contents are anticancer drugs.
  • the attachment 7 formed by attaching the vial adapter 1 to the vial 2 is turned upside down, and the mixed liquid is sucked from the vial 2 through the fluid flow path 3 into the suction/discharge device (see the thick arrow in Figure 4).
  • the amount of gas sucked from the suction port 4a may become too large and the fluctuation space 4b may not be able to contract sufficiently.
  • the capacity of the gas flow path 4 (fluctuation space 4b) to return all of the liquid to the vial 2 is likely to be insufficient.
  • the deformable membrane 6a comes into contact with the inner surface of the membrane fixing portion 6b when a predetermined volume of gas that is 1.3 times the maximum volume of the variable space 4b is sucked from the gas flow path 4 into the vial 2 at a predetermined flow rate within the range of 0.1 to 10 cm3 /s that remains constant over time from the most expanded state in which the volume of the variable space 4b is maximum.
  • variable space 4b in the most expanded state is a space partitioned by the inner surface of the deformation membrane 6a in the most expanded state and the above-mentioned inner surface of the deformation membrane 6a in the most contracted state. Therefore, the volume of this space is the maximum volume of the variable space 4b.
  • the variable space 4b in the most contracted state coincides with the above-mentioned inner surface of the deformation membrane 6a in the most contracted state. Therefore, the minimum volume of the variable space 4b is zero.
  • the specified volume is preferably 1.0 times the maximum volume of the variable space 4b.
  • the predetermined flow rate is preferably within a range of 0.5 to 5 cm 3 /s.
  • the maximum volume of the fluctuation space 4b is preferably within the range of 5 to 500 mL. More preferably, it is within the range of 10 to 100 mL. With the above configuration, it is possible to further reduce the occurrence of a shortage in the capacity of the gas flow path 4 for returning all the liquid to the vial 2.
  • the membrane fixing portion 6b has a bowl-shaped portion 8, and the deformable membrane 6a comes into contact with the inner surface 8a of the bowl-shaped portion 8 of the membrane fixing portion 6b (see FIG. 4) when, in an unobstructed state, a predetermined volume of gas is sucked from the gas flow path 4 into the vial 2 at a predetermined flow rate that remains constant over time from the most expanded state.
  • the bowl-shaped portion 8 has a peripheral wall portion 8b, a bottom wall portion 8c connected to the peripheral wall portion 8b, and a flange portion 8d connected to the end of the peripheral wall portion 8b opposite the bottom wall portion 8c.
  • the deformation membrane 6a is formed of a bowl-shaped flexible sheet material. The outer periphery of the deformation membrane 6a is fixed to the flange portion 8d. With the above configuration, the volume fluctuation portion 6 can be easily formed.
  • the backflow suppression unit 5 is composed of a one-way valve 5a. With the above configuration, the backflow suppression unit 5 can be easily formed.
  • the one-way valve 5a is a duckbill valve. With the above configuration, the backflow prevention section 5 can be easily formed.
  • the gas flow path 4 has a branching section 4c that branches into the fluctuation space 4b side and the suction port 4a side.
  • the vial adapter 1 has a first filter 9 arranged between the fluctuation space 4b and the branching portion 4c in the gas flow path 4. This configuration makes it possible to prevent foreign matter from entering the mixed liquid.
  • the first filter 9 is made of a hydrophobic material. With the above configuration, even if the mixed liquid enters the gas flow path 4, the mixed liquid can be prevented from entering the fluctuation space 4b via the first filter 9.
  • the vial adapter 1 has a second filter 10 that is disposed between the suction port 4a and the branching portion 4c in the gas flow path 4. This configuration makes it possible to prevent foreign matter from entering the mixed liquid.
  • the second filter 10 is preferably made of a hydrophobic material. With the above configuration, even if the mixed liquid enters the gas flow path 4, the mixed liquid can be prevented from being discharged to the outside through the suction port 4a via the second filter 10.
  • the second filter 10 may be made of a hydrophilic material.
  • the suction port 4a when the suction port 4a is blocked by an obstructing member 11 such as a sheet-like adhesive member that obstructs suction from the suction port 4a, the first suction force when gas equivalent to the maximum volume of the variable space 4b from the most expanded state is sucked into the vial 2 at a predetermined flow rate that remains constant over time is always smaller from the start to the end of suction, compared to the second suction force when gas equivalent to the maximum volume of the variable space 4b is sucked into the vial 2 from the suction port at a predetermined flow rate that remains constant over time in the most contracted state in which the volume of the variable space 4b is at its smallest, as shown in FIG. 6.
  • an obstructing member 11 such as a sheet-like adhesive member that obstructs suction from the suction port 4a
  • the first suction force can be measured, for example, by connecting a suction force measuring device to the liquid flow path with a vial 2 attached to the vial adapter 1 as shown in Figure 5, and using the suction force measuring device to aspirate a predetermined flow rate of gas that remains constant over time from the gas flow path 4 through the liquid flow path and the vial 2 (see the thick arrow and hollow arrow in Figure 5) while recording the suction force required for this aspirate. Measurements may also be made by directly aspirating the gas flow path 4 without attaching the vial 2.
  • the second suction force can be measured, for example, by connecting a suction force measuring device to the liquid flow path with a vial 2 attached to the vial adapter 1 as shown in Figure 6, and using the suction force measuring device to aspirate a predetermined flow rate of gas that remains constant over time from the gas flow path 4 through the liquid flow path and the vial 2 (see the thick arrow and hollow arrow in Figure 6) while recording the suction force required for this aspirate. Measurements may also be made by directly aspirating the gas flow path 4 without attaching the vial 2.
  • Methods for reducing the first suction force include, for example, reducing the thickness of the deformation membrane 6a, increasing the pore size of the first filter 9, and increasing the effective area of the first filter 9.
  • Methods for increasing the second suction force include, for example, reducing the effective flow path cross-sectional area when the one-way valve 5a is open (such as reducing the slit length of the duckbill valve), reducing the hole diameter of the second filter 10, and reducing the effective area of the second filter 10.
  • the vial adapter 1 has a spike portion 12 that can pierce the stopper 2a of the vial 2.
  • the spike portion 12 has a first communication port 3a that connects the liquid flow path to the inside of the vial 2.
  • the first communication port 3a is provided on the side wall of the spike portion 12.
  • the liquid flow path extends from a connection port 3b to which an aspiration/discharge device can be connected to the communication port.
  • the vial adapter 1 has a medical device connection portion 13 that forms the connection port 3b.
  • the medical device connection part 13 has a valve body 13a that can close the connection port 3b.
  • the medical device connection part 13 is a closed type. With the above configuration, it is possible to prevent foreign matter from entering the liquid flow path.
  • the spike portion 12 has a second communication port 4d that connects the gas flow path 4 to the inside of the vial 2.
  • the second communication port 4d is provided closer to the tip of the spike portion 12 than the first communication port 3a.
  • the vial adapter 1 has a fluid flow path 3 capable of discharging liquid from within a vial 2, a gas flow path 4 having an aspiration port 4a and capable of sucking gas from the aspiration port 4a into the vial 2, a backflow suppression section 5 disposed in the gas flow path 4 and restricting the gas from being discharged from the aspiration port 4a, and a volume fluctuation section 6 forming a variable space 4b in the gas flow path 4 whose volume can be varied, the volume fluctuation section 6 having a deformation membrane 6a that can be deformed in response to the pressure in the gas flow path 4, and a membrane fixing section 6b to which the deformation membrane 6a is fixed and which forms the variable space 4b between the deformation membrane 6a and the membrane fixing section 6b, and the deformation membrane 6a, in an unobstructed state in which the aspiration from the aspiration port 4a is not obstructed, flows from the gas flow path 4 into the vial 2 at a volume that is constant

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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)
PCT/JP2023/040630 2023-01-18 2023-11-10 バイアルアダプタ Pending WO2024154420A1 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024571629A JPWO2024154420A1 (enrdf_load_stackoverflow) 2023-01-18 2023-11-10

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2023-005992 2023-01-18
JP2023005992 2023-01-18

Publications (1)

Publication Number Publication Date
WO2024154420A1 true WO2024154420A1 (ja) 2024-07-25

Family

ID=91955577

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2023/040630 Pending WO2024154420A1 (ja) 2023-01-18 2023-11-10 バイアルアダプタ

Country Status (2)

Country Link
JP (1) JPWO2024154420A1 (enrdf_load_stackoverflow)
WO (1) WO2024154420A1 (enrdf_load_stackoverflow)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070106244A1 (en) * 2005-11-07 2007-05-10 Gilero, Llc Vented safe handling vial adapter
WO2015118432A1 (en) * 2014-02-07 2015-08-13 Industrie Borla S.P.A. Access device for containers of fluidizable substances

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070106244A1 (en) * 2005-11-07 2007-05-10 Gilero, Llc Vented safe handling vial adapter
WO2015118432A1 (en) * 2014-02-07 2015-08-13 Industrie Borla S.P.A. Access device for containers of fluidizable substances

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Publication number Publication date
JPWO2024154420A1 (enrdf_load_stackoverflow) 2024-07-25

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