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WO2024242914A1 - Adaptateur de seringue avec boîtier de membrane - Google Patents

Adaptateur de seringue avec boîtier de membrane Download PDF

Info

Publication number
WO2024242914A1
WO2024242914A1 PCT/US2024/029047 US2024029047W WO2024242914A1 WO 2024242914 A1 WO2024242914 A1 WO 2024242914A1 US 2024029047 W US2024029047 W US 2024029047W WO 2024242914 A1 WO2024242914 A1 WO 2024242914A1
Authority
WO
WIPO (PCT)
Prior art keywords
housing
membrane
outer housing
syringe adapter
biasing member
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/US2024/029047
Other languages
English (en)
Inventor
Rafael GONZALEZ MACIAS
Nicole Jean DISTEFANO
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.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
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 Becton Dickinson and Co filed Critical Becton Dickinson and Co
Publication of WO2024242914A1 publication Critical patent/WO2024242914A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

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
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1027—Quick-acting type connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1044—Verifying the connection, e.g. audible feedback, tactile feedback, visual feedback, using external light sources
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1061—Break-apart tubing connectors or couplings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1072—Tube connectors; Tube couplings with a septum present in the connector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1077—Adapters, e.g. couplings adapting a connector to one or several other connectors

Definitions

  • the present invention relates to a syringe adapter with a membrane housing.
  • Health care providers reconstituting, transporting, and administering hazardous drugs, such as chemotherapeutic medication, can put health care providers at risk of exposure to these medications and present a hazard in the health care environment. Unintentional chemotherapy exposure can affect the nervous system, impair the reproductive system, and bring an increased risk of developing blood cancers in the future.
  • Some drugs must be dissolved or diluted before they are administered, which involves transferring a solvent from one container to a sealed vial containing the drug in powder or liquid form. Drugs may be inadvertently released into the atmosphere in gas form or by way of aerosolization, during the withdrawal of the medication from the vial if any pressure differential between the interior of the vial and the surrounding atmosphere exists. In order to reduce the risk of health care providers being exposed to toxic drugs, the transfer of these drugs is accomplished utilizing a closed system transfer device or system.
  • Syringe adapters are utilized with a syringe to transfer medication from a container, such as a vial, to the syringe or to transfer a diluent from the syringe to the vial to reconstitute a medication.
  • Syringe adapters are also utilized to transfer medication from the syringe to a patient infusion line or to an infusion container, such as an IV bag, via an IV bag spike.
  • Syringe adapters include a membrane received by a membrane housing, with the membrane of the syringe adapter configured to engage a corresponding membrane of a mating component, such as a patient connector, vial adapter, or IV bag spike, to ensure the closed transfer of fluid between the components such that the medication is not exposed to the ambient environment.
  • a mating component such as a patient connector, vial adapter, or IV bag spike
  • a syringe adapter includes an outer housing having a first end and a second end positioned opposite the first end with a longitudinal axis extending from the first end of the outer housing to the second end of the outer housing, with the outer housing including a sidewall defining an interior space, a syringe connection configured to be connected to a syringe, and a membrane housing positioned within the interior space of the outer housing and moveable from a first position within the outer housing to a second position within the outer housing spaced from the first position.
  • the membrane housing receives a membrane.
  • the membrane housing includes a biasing member configured to engage the sidewall of the outer housing, the biasing member configured to provide a biasing force in a direction perpendicular to the longitudinal axis of the outer housing.
  • An inner diameter of the outer housing may be larger at the second end of the outer housing than the inner diameter of the outer housing at the first end of the housing, where the biasing member engages the sidewall of the outer housing as the membrane housing moves from the first position to the second position.
  • the biasing member of the membrane housing may be configured to bias the membrane housing toward the first position as the membrane housing moves from the first position to the second position.
  • the inner diameter of the outer housing may taper from the first end of the outer housing to the second end of the outer housing.
  • the biasing member may extend radially outward from the membrane housing.
  • the biasing member may include a plurality of arcuate projections.
  • Each of the plurality of arcuate projections may include a first end connected to the membrane housing, a second end positioned opposite to the first end, and a contact surface configured to engage an inner surface of the sidewall of the outer housing.
  • the contact surface of each of the plurality of arcuate projections may have a radius equal to a radius of a portion of the inner surface of the sidewall of the outer housing.
  • the biasing member may be configured to center the membrane housing within the interior space of the outer housing.
  • the membrane housing may have a first end and a second end positioned opposite the first end of the membrane housing, where the biasing member is positioned between the first and second ends of the membrane housing.
  • the biasing member may be positioned closer to the first end of the membrane housing than the second end of the membrane housing.
  • the syringe adapter may further include a needle received within the interior space of the outer housing.
  • a piercing tip of the needle may be positioned within the membrane when the membrane housing is in the first position, where the piercing tip of the needle is positioned outside of the membrane when the membrane housing is in the second position.
  • the membrane housing may include a collet configured to receive a connection interface of a mating connector.
  • FIG. 1 is a front view of a conventional syringe adapter.
  • FIG. 2 is a cross-sectional view of the syringe adapter of FIG. 1.
  • FIG. 3 is a perspective view of a membrane housing according to one aspect or embodiment of the present application.
  • FIG. 4 is a top view of the membrane housing of FIG. 3.
  • FIG. 5 is a cross-sectional view of the membrane housing of FIG. 3, showing the membrane housing engaged with a syringe adapter housing.
  • the syringe adapter 10 is one component of a system for the closed transfer of fluids.
  • the syringe adapter 10 is configured to connect to a syringe (not shown) and to another medical device or fluid container.
  • the medical device can be, for example, a patient line, vial adapter, fluid container, or infusion adapter.
  • the container can be a medical vial, syringe barrel, IV bag, or similar container for holding a fluid to be administered to a patient.
  • the syringe adapter 10 can be used to facilitate the closed transfer of fluids between the syringe and medical device or fluid container.
  • the syringe adapter 10 is shown and described in U.S. Patent Application Publication No. 2018/0200147, which is hereby incorporated by reference in its entirety.
  • the syringe adapter 10 includes an outer housing 12, a syringe connection 14, and a membrane housing 16.
  • the outer housing 12 has a first end 18 and a second end 20 positioned opposite the first end 18 with a longitudinal axis A extending from the first end 18 of the outer housing 12 to the second end 20 of the outer housing 12.
  • the outer housing 12 includes a sidewall 22 defining an interior space 24.
  • the syringe connection 14 is configured to be connected to a syringe.
  • the syringe connection 14 may be a luer connector, although other suitable connection arrangements may be utilized.
  • the membrane housing 16 is positioned within the interior space 24 of the outer housing 12 and is moveable from a first position within the outer housing 12 to a second position within the outer housing 12 that is spaced from the first position.
  • the membrane housing 12 receives a membrane 26.
  • the syringe adapter 10 further includes a needle 28 received within the interior space 24 of the outer housing 12. A piercing tip 30 of the needle 28 is positioned within the membrane 26 when the membrane housing 16 is in the first position and the piercing tip 30 of the needle 28 is positioned outside of the membrane 26 when the membrane housing 16 is in the second position.
  • the membrane housing 16 includes a collet 32 configured to receive a connection interface 34 of a mating connector 36, such as a patient connecter as shown in FIGS. 1 and 2.
  • the mating connector 36 includes a membrane 38.
  • the mating connector 36 may be other components of a closed system transfer device or system, such as a vial adapter or IV bag spike.
  • the syringe adapter 10 also includes a spring 40 received within the interior space 24 of the outer housing 12. The spring 40 biases the membrane housing 16 toward the first position.
  • the collet 32 of the membrane housing 16 receives the connection interface 34 of the mating connector 36 and moves the membrane housing 16 within the outer housing 12 toward the first end of the outer housing 12. As the membrane housing 16 moves, the collet 32 secures the membrane housing 16 to the mating connector 36 to ensure engagement between the membrane 38 of the mating connector 36 and the membrane 26 of the membrane housing 16.
  • the piercing tip 30 of the needle 28 pierces the membrane 26 of the membrane housing 16 and the membrane 38 of the mating connector 36 such that the piercing tip 30 is received within the mating connector 36 thereby placing the needle 28 in fluid communication with the mating connector 36.
  • the syringe connection 14 is in fluid communication with the needle 28 to allow a syringe (not shown) connected to the syringe connection 14 to be in fluid communication with the mating connector 36 when the syringe adapter 10 is connected to the mating connector 36.
  • the membrane housing 16 Moving the membrane housing 16 from the second position to the first position, which is aided by the spring 40, releases the mating connector 36 from the collet 32 to separate the mating connector 36 from the syringe adapter 10.
  • the membrane housing 16 is secured in the second position by a locking arrangement 42 of the mating connector 36 that engages a portion of the outer housing 12 to hold the membrane housing 16 in the second position. Pulling the mating connector 36 away from the syringe adapter 10 releases the locking arrangement 42 to allow the membrane housing 16 to move back to the first position from the second position.
  • the syringe adapter 10 includes a membrane housing 60 having a biasing member 62 configured to engage the sidewall 22 of the outer housing 12.
  • the biasing member 62 is configured to provide a biasing force in a direction perpendicular to the longitudinal axis A of the outer housing 12.
  • the membrane housing 60 receives the membrane 26 and may be utilized with the syringe adapter 10 shown in FIGS. 1 and 2 and operate in the same manner as the membrane housing 16 discussed above, except for the differences discussed below.
  • the membrane housing 60 of FIGS. 3-5 may also be utilized in connection with other types of syringe adapters, such as syringe adapters not including the spring or not including the needle.
  • the biasing member 62 of the membrane housing 60 is configured to automatically center the membrane housing 60 within the interior space 24 of the outer housing 12 to ensure consistent operation of the syringe adapter 10.
  • the biasing member 62 of the membrane housing 60 is configured to compensate for dimension variations in the parts of the syringe adapter 10 to ensure consistent functionality.
  • an inner diameter 64 of the outer housing 12 is larger at the second end 20 of the outer housing 12 than an inner diameter of the outer housing 12 at the first end 18 of the outer housing 12.
  • the biasing member 62 engages the sidewall 22 of the outer housing 12 as the membrane housing 60 moves from the first position to the second position.
  • the biasing member 62 of the membrane housing 60 is configured to bias the membrane housing 60 toward the first position as the membrane housing 60 moves from the first position to the second position.
  • the biasing member 62 eliminates the need for the spring 40 and returns the membrane housing 60 to the first position from the second position.
  • the inner diameter 64 of the outer housing 12 tapers from the first end 18 of the outer housing 12 to the second end 20 of the outer housing 12, although other suitable arrangements may be utilized.
  • the biasing force provided by the biasing member 62 may increase as the membrane housing 60 moves toward the second position closer to the first end 18 of the outer housing 12.
  • the biasing member 62 extends radially outward from the membrane housing 60.
  • the biasing member 62 is formed integrally with the membrane housing 60, although the biasing member 62 may be formed separately from the membrane housing 60 and may be secured to the membrane housing 60 in any suitable manner. As shown in FIGS. 3 and 4, the biasing member 62 is a plurality of arcuate projections 66, although one or more arcuate projections 66 may be utilized. As shown in FIG. 4, the biasing member 62 includes five equally- spaced arcuate projections 66.
  • Each of the plurality of arcuate projections 66 includes a first end 68 connected to the membrane housing 60, a second end 70 positioned opposite to the first end 68, and a contact surface 72 configured to engage an inner surface 74 of the sidewall 22 of the outer housing 12.
  • the contact surface 72 of each of the plurality of arcuate projections 66 has a radius equal to a radius of a portion of the inner surface 74 of the sidewall 22 of the outer housing 12.
  • the contact surface 72 of each of the plurality of arcuate projections 66 is curved, although other suitable arrangements may be utilized.
  • the membrane housing 60 has a first end 78 and a second end 80 positioned opposite the first end 78 of the membrane housing 60.
  • the biasing member 62 is positioned between the first and second ends 78, 80 of the membrane housing 60.
  • the biasing member 62 is positioned closer to the first end 78 of the membrane housing 60 than the second end 80 of the membrane housing 60, although other suitable positions may be utilized.

Landscapes

  • 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)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un adaptateur de seringue comprenant un boîtier externe doté d'une première extrémité et d'une seconde extrémité opposée à la première, avec un axe longitudinal s'étendant de la première à la seconde extrémité du boîtier externe, le boîtier externe comprenant une paroi latérale définissant un espace interne, un raccord de seringue configuré pour être raccordé à une seringue, et un boîtier de membrane positionné dans l'espace interne du boîtier externe et pouvant être déplacé d'une première position à l'intérieur du boîtier externe à une seconde position à l'intérieur du boîtier externe, à distance de la première position. Le boîtier de membrane reçoit une membrane. Le boîtier de membrane comprend un élément de sollicitation conçu pour venir en prise avec la paroi latérale du boîtier externe, l'élément de sollicitation étant conçu pour fournir une force de sollicitation dans une direction perpendiculaire à l'axe longitudinal du boîtier externe.
PCT/US2024/029047 2023-05-25 2024-05-13 Adaptateur de seringue avec boîtier de membrane Pending WO2024242914A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363468896P 2023-05-25 2023-05-25
US63/468,896 2023-05-25

Publications (1)

Publication Number Publication Date
WO2024242914A1 true WO2024242914A1 (fr) 2024-11-28

Family

ID=93590243

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/029047 Pending WO2024242914A1 (fr) 2023-05-25 2024-05-13 Adaptateur de seringue avec boîtier de membrane

Country Status (1)

Country Link
WO (1) WO2024242914A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150297454A1 (en) * 2014-04-21 2015-10-22 Becton Dickinson and Company Limited System for Closed Transfer of Fluids
US20180200498A1 (en) * 2017-01-17 2018-07-19 Becton Dickinson and Company Limited Connector for System for Closed Transfer of Fluids
US20180200147A1 (en) * 2017-01-17 2018-07-19 Becton Dickinson and Company Limited Syringe Adapter for Closed Transfer of Fluids
WO2022093878A1 (fr) * 2020-10-28 2022-05-05 Becton, Dickinson And Company Membrane avec surface de guidage
WO2023018926A1 (fr) * 2021-08-12 2023-02-16 Becton, Dickinson And Company Adaptateur de seringue avec raccord d'aiguille

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150297454A1 (en) * 2014-04-21 2015-10-22 Becton Dickinson and Company Limited System for Closed Transfer of Fluids
US20180200498A1 (en) * 2017-01-17 2018-07-19 Becton Dickinson and Company Limited Connector for System for Closed Transfer of Fluids
US20180200147A1 (en) * 2017-01-17 2018-07-19 Becton Dickinson and Company Limited Syringe Adapter for Closed Transfer of Fluids
WO2022093878A1 (fr) * 2020-10-28 2022-05-05 Becton, Dickinson And Company Membrane avec surface de guidage
WO2023018926A1 (fr) * 2021-08-12 2023-02-16 Becton, Dickinson And Company Adaptateur de seringue avec raccord d'aiguille

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