WO2025155511A1 - System for closed fluid transfer - Google Patents

System for closed fluid transfer

Info

Publication number
WO2025155511A1
WO2025155511A1 PCT/US2025/011486 US2025011486W WO2025155511A1 WO 2025155511 A1 WO2025155511 A1 WO 2025155511A1 US 2025011486 W US2025011486 W US 2025011486W WO 2025155511 A1 WO2025155511 A1 WO 2025155511A1
Authority
WO
WIPO (PCT)
Prior art keywords
membrane
housing
component
connection interface
syringe adapter
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/US2025/011486
Other languages
French (fr)
Inventor
Jason Andrew WINE
Siddarth K. SHEVGOOR
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 WO2025155511A1 publication Critical patent/WO2025155511A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1027Quick-acting type connectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1072Tube connectors; Tube couplings with a septum present in the connector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1077Adapters, e.g. couplings adapting a connector to one or several other connectors

Definitions

  • a portion of the component housing may be configured to be received within the interior space of the housing of the syringe adapter to move the membrane from the first position to the second position, with the first connection is configured to engage the second connection interface when the portion of the component housing is positioned within the interior space of the housing of the syringe adapter with the membrane in the second position.
  • the syringe adapter may further include a membrane base connected to the membrane, with the biasing member in contact with the membrane base.
  • a system for closed transfer of fluids includes a syringe adapter having a housing having a first end and a second end positioned opposite the first end, with the housing includes a sidewall defining an interior space, a membrane received within the interior space of the housing and moveable from a first position within the housing to a second position within the housing spaced from the first position and a portion of the membrane extending outside of the interior space of the housing, a hub positioned at the first end of the housing and configured to be connected to a syringe, a needle connected to the hub, with the needle having a first end and a second end positioned opposite the first end and the second end of the needle received within the membrane when membrane is in the first position, a biasing member received within the housing, with the biasing member biasing the membrane toward the first position, and a first connection interface positioned on an outer surface of the housing.
  • a portion of the component housing may be configured to be received within the interior space of the housing of the syringe adapter to move the membrane from the first position to the second position, with the first connection interface configured to engage the second connection interface when the portion of the component housing is positioned within the interior space of the housing of the syringe adapter with the membrane in the second position.
  • the syringe adapter may include a membrane base connected to the membrane, with the biasing member in contact with the membrane base.
  • FIG. 1 is a front view of a conventional syringe adapter and patient connector
  • FIG. 2 is a cross-sectional view of the syringe adapter and patient connector of FIG. 1;
  • FIG. 3 is a perspective view of a system for closed transfer of fluids according to one aspect or embodiment of the present application, showing a syringe adapter and a secondary component connected to each other;
  • FIG. 6 is a cross-sectional view of the system of FIG. 3, showing a syringe adapter and a secondary component connected to each other;
  • FIG. 9 is a cross-sectional view of the system of FIG. 7, showing a syringe adapter and a secondary component connected to each other;
  • FIG. 11 is a cross-sectional view of the system of FIG. 10, showing a syringe adapter and a secondary component separated from each other;
  • FIG. 12 is a cross-sectional view of the system of FIG. 10, showing a syringe adapter and a secondary component connected to each other;
  • FIG. 13 is a front view of a conventional syringe adapter and patient connector in comparison with exemplary systems of the present application.
  • FIG. 14 is a perspective view of a conventional syringe adapter and patient connector in comparison with exemplary systems of the present application.
  • 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 transfer of fluids between the syringe and medical device or fluid container while preventing dripping of the fluid or expelling of the fluid outside of the system.
  • 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 needle hub 14 having a syringe connection, 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 needle hub 14 is configured to be connected to a syringe.
  • the needle hub 14 may include a luer connector, although other suitable connection arrangements may be utilized.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A system for closed transfer of fluids includes a syringe adapter having a housing, a membrane at least partially received within an interior space of the housing, a hub positioned at the first end of the housing, a needle connected to the needle hub, a biasing member received within the housing and biasing the membrane toward the first position, and a first connection interface positioned on an outer surface of the housing. The system also includes a secondary component having a component housing, a first component membrane, a second component, with the first component membrane spaced from the second component membrane, and a second connection interface positioned on an outer surface of the component housing.

Description

SYSTEM FOR CLOSED FLUID TRANSFER
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application claims priority to United States Provisional Patent Application No. 63/620,962 entitled “System for Closed Fluid Transfer” filed January 15, 2024, the disclosure of which is hereby incorporated by reference in its entirety.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The present invention relates to a system for the closed transfer of fluids and, more particularly, a syringe adapter and corresponding connector.
Description of Related Art
[0003] 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.
[0004] 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. SUMMARY OF THE INVENTION
[0005] In one aspect or embodiment, a system for closed transfer of fluids includes a syringe adapter having a housing with a first end and a second end positioned opposite the first end, the housing includes a sidewall defining an interior space, a membrane at least partially received within the interior space of the housing and moveable from a first position within the housing to a second position within the housing spaced from the first position, a hub positioned at the first end of the housing and configured to be connected to a syringe, a needle connected to the needle hub, with the needle having a first end and a second end positioned opposite the first end, and with the second end of the needle received within the membrane when membrane is in the first position, a biasing member received within the housing, with the biasing member biasing the membrane toward the first position, and a first connection interface positioned on an outer surface of the housing. The system also includes a secondary component having a component housing with a first end and a second end positioned opposite the first end, with the component housing including a sidewall defining passageway, a first component membrane at least partially received within the passageway, a second component membrane at least partially received within the passageway, with the first component membrane spaced from the second component membrane, and a second connection interface positioned on an outer surface of the component housing. The second connection interface is configured to engage the first connection interface to secure the syringe adapter to the secondary component.
[0006] A portion of the component housing may be configured to be received within the interior space of the housing of the syringe adapter to move the membrane from the first position to the second position, with the first connection is configured to engage the second connection interface when the portion of the component housing is positioned within the interior space of the housing of the syringe adapter with the membrane in the second position. The syringe adapter may further include a membrane base connected to the membrane, with the biasing member in contact with the membrane base. The membrane may include a head portion and a stem portion extending from the head portion, with the head portion including a convex surface and the stem portion including a protrusion, and with the stem portion of the membrane received within an opening defined by the membrane base and the protrusion of the stem portion securing the membrane to the membrane base. The stem portion of the membrane may define an opening and include a needle sealing portion extending into the opening, with the needle sealing portion configured to engage a portion of the needle. [0007] The convex surface of the head portion of the membrane may be at least partially positioned outside of the interior space of the housing. A portion of the second component membrane may be positioned outside of the passageway of the component housing.
[0008] The secondary component may include a luer connector. The first connection interface may be an annular groove and the second connection interface may be a cantilever arm.
[0009] In a further aspect or embodiment, a system for closed transfer of fluids includes a syringe adapter having a housing having a first end and a second end positioned opposite the first end, with the housing includes a sidewall defining an interior space, a membrane received within the interior space of the housing and moveable from a first position within the housing to a second position within the housing spaced from the first position and a portion of the membrane extending outside of the interior space of the housing, a hub positioned at the first end of the housing and configured to be connected to a syringe, a needle connected to the hub, with the needle having a first end and a second end positioned opposite the first end and the second end of the needle received within the membrane when membrane is in the first position, a biasing member received within the housing, with the biasing member biasing the membrane toward the first position, and a first connection interface positioned on an outer surface of the housing. The system also includes a secondary component having a component housing having a first end and a second end positioned opposite the first end, with the component housing includes a sidewall defining passageway, a component membrane received within the passageway of the component, with a portion of the component membrane extending outside of the passageway of the component housing, and a second connection interface positioned on an outer surface of the component housing. The second connection interface is configured to engage the first connection interface to secure the syringe adapter to the secondary component. [0010] A portion of the component housing may be configured to be received within the interior space of the housing of the syringe adapter to move the membrane from the first position to the second position, with the first connection interface configured to engage the second connection interface when the portion of the component housing is positioned within the interior space of the housing of the syringe adapter with the membrane in the second position. The syringe adapter may include a membrane base connected to the membrane, with the biasing member in contact with the membrane base. The membrane may include a head portion and a stem portion extending from the head portion, with the head portion including a convex surface and the stem portion including a protrusion, and with the stem portion of the membrane received within an opening defined by the membrane base and the protrusion of the stem portion securing the membrane to the membrane base. The stem portion of the membrane may define an opening and include a needle sealing portion extending into the opening, with the needle sealing portion configured to engage a portion of the needle. The convex surface of the head portion of the membrane may be at least partially positioned outside of the passageway of the component housing.
[0011] The component membrane may include a head portion and a stem portion extending from the head portion, with the head portion including a convex surface. The convex surface of the head portion of the component membrane may be at least partially positioned outside of the interior space of the housing. The first connection interface may include a recessed portion and the second connection interface may be a cantilever arm. The hub may include an extension extending from the first end of the housing of the syringe adapter toward the second end of the housing the syringe adapter, with the recessed portion of the first connection interface positioned on the extension. The hub and the housing of the syringe adapter may be formed integrally.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a front view of a conventional syringe adapter and patient connector;
[0013] FIG. 2 is a cross-sectional view of the syringe adapter and patient connector of FIG. 1;
[0014] FIG. 3 is a perspective view of a system for closed transfer of fluids according to one aspect or embodiment of the present application, showing a syringe adapter and a secondary component connected to each other;
[0015] FIG. 4 is a perspective view of the system of FIG. 3, showing a syringe adapter and a secondary component separated from each other;
[0016] FIG. 5 is a cross-sectional view of the system of FIG. 3, showing a syringe adapter and a secondary component separated from each other;
[0017] FIG. 6 is a cross-sectional view of the system of FIG. 3, showing a syringe adapter and a secondary component connected to each other;
[0018] FIG. 7 is a perspective view of a system for closed transfer of fluids according to a further aspect or embodiment of the present application, showing a syringe adapter and a secondary component connected to each other; [0019] FIG. 8 is a cross-sectional view of the system of FIG. 7, showing a syringe adapter and a secondary component separated from each other;
[0020] FIG. 9 is a cross-sectional view of the system of FIG. 7, showing a syringe adapter and a secondary component connected to each other;
[0021] FIG. 10 is a perspective view of a system for closed transfer of fluids according to a further aspect or embodiment of the present application, showing a syringe adapter and a secondary component connected to each other;
[0022] FIG. 11 is a cross-sectional view of the system of FIG. 10, showing a syringe adapter and a secondary component separated from each other;
[0023] FIG. 12 is a cross-sectional view of the system of FIG. 10, showing a syringe adapter and a secondary component connected to each other;
[0024] FIG. 13 is a front view of a conventional syringe adapter and patient connector in comparison with exemplary systems of the present application; and
[0025] FIG. 14 is a perspective view of a conventional syringe adapter and patient connector in comparison with exemplary systems of the present application.
DETAILED DESCRIPTION
[0026] For purposes of the description hereinafter, the terms such as “end”, “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting. Further, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary.
[0027] Referring to FIGS. 1 and 2, a conventional syringe adapter 10 is shown. The syringe adapter 10 is one component of a system for the closed transfer of fluids. In particular, 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 transfer of fluids between the syringe and medical device or fluid container while preventing dripping of the fluid or expelling of the fluid outside of the system. 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.
[0028] Referring again to FIGS. 1 and 2, the syringe adapter 10 includes an outer housing 12, a needle hub 14 having a syringe connection, 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 needle hub 14 is configured to be connected to a syringe. The needle hub 14 may include 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 16 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 needle 28 is secured to the needle hub 14 and rotates with the needle hub 14. In particular, the needle hub 14 is rotatable relative to the outer housing 12, which inhibits accidental disconnection of a syringe from the needle hub 14 by requiring a healthcare worker to grasp the needle hub 14 to connect and disconnect a syringe from the needle hub 14. 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.
[0029] When the mating connector 36 is inserted into the outer housing 12 of the syringe adapter 10, 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. As the membrane housing 16 is moved from the first position to the second position, 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 needle hub 14 is in fluid communication with the needle 28 to allow a syringe (not shown) connected to the needle hub 14 to be in fluid communication with the mating connector 36 when the syringe adapter 10 is connected to the mating connector 36. 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.
[0030] Referring to FIGS. 3-6, according to one aspect or embodiment of the present application, a system 100 for closed transfer of fluids includes a syringe adapter 102 and a secondary component 104. The syringe adapter 102 includes a housing 106 having a first end 108 and a second end 110 positioned opposite the first end 108, with the housing 106 having a sidewall 112 defining an interior space 114, a membrane 116 at least partially received within the interior space 114 of the housing 106 and moveable from a first position within the housing 106 to a second position within the housing 106 spaced from the first position, a hub 118 positioned at the first end 108 of the housing 106 and configured to be connected to a syringe, a needle 120 connected to the hub 118, a biasing member 122 received within the housing 106, and a first connection interface 124 positioned on an outer surface of the housing 106. The biasing member 122 biases the membrane 116 toward the first position. The needle 120 has a first end 126 and a second end 128 positioned opposite the first end 126, with the second end 128 of the needle 120 received within the membrane 116 when membrane 116 is in the first position. The secondary component 104 includes a component housing 130 having a first end 132 and a second end 134 positioned opposite the first end 132, with the component housing 130 having a sidewall 136 defining passageway 138, a first component membrane 140 at least partially received within the passageway 138, a second component membrane 142 at least partially received within the passageway 138, with the first component membrane 140 spaced from the second component membrane 142. The secondary component 104 also includes a second connection interface 144 positioned on an outer surface of the component housing 130, with the second connection interface 144 configured to engage the first connection interface 124 to secure the syringe adapter 102 to the secondary component 104.
[0031] In one aspect or embodiment, the system 100 of FIGS. 3-6 operates similarly to the syringe adapter 10 and the mating connector 36 shown in FIGS. 1 and 2 and discussed above. A portion of the component housing 130 is configured to be received within the interior space 114 of the housing 106 of the syringe adapter 102 to move the membrane 116 from the first position to the second position. The first connection interface 124 is configured to engage the second connection interface 144 when the portion of the component housing 130 is positioned within the interior space 114 of the housing 106 of the syringe adapter 102 with the membrane 116 in the second position.
[0032] In contrast to the syringe adapter 10 of FIGS. 1 and 2, however, the syringe adapter 102 does not include the collet 32 and relies on the biasing member 122 to ensure engagement and sealed surface between the second component membrane 142 and the membrane 116 of the syringe adapter 102. When the component housing 130 is inserted into the interior space 114 of the housing 106 of the syringe adapter 102, the second component membrane 142 engages the membrane 116 of the syringe adapter 102 with further movement of the secondary component 104 relative to the syringe adapter 102 causing movement of the membrane 116 from the first position to the second position and compression of the biasing member 122. Only the force from the biasing member 122 ensures the engagement between the second component membrane 142 and the membrane 116 of the syringe adapter 102. Further, in contrast to the mating connector 36 of FIGS. 1 and 2, the secondary component 104 includes the first component membrane 140 and the second component membrane 142 rather than a single membrane, which is configured to reduce the likelihood of leaks or drips during fluid transfer between the syringe adapter 102 and the secondary component 104. As shown in FIG. 6, with the secondary component 104 connected to the syringe adapter 102 and the second component membrane 142 engaged with the membrane 116 of the syringe adapter 102, the needle 120 extends through the membrane 116, the second component membrane 142, and the first component membrane 140, with the needle 120 in fluid communication with the passageway 138 of the secondary component 104. The first component membrane 140 and the second component membrane 142 as well as the spaced apart relationship ensures fluid is contained within the system 100. [0033] Referring again to FIGS. 3-6, in one aspect or embodiment, the syringe adapter 102 further includes a membrane base 146 connected to the membrane 116, with the biasing member 122 in contact with the membrane base 146. The biasing member 122 is a compression spring, although other suitable biasing members may be utilized, including but not limited to a compressible material, hydraulic or pneumatic members, and/or flexible materials or shapes. The membrane 116 includes a head portion 152 and a stem portion 154 extending from the head portion 152, with the head portion 152 including a convex surface 156 and the stem portion 154 including a protrusion 158. The stem portion 154 of the membrane 116 is received within an opening defined by the membrane base 146, with the protrusion 158 of the stem portion 154 securing the membrane 116 to the membrane base 146. The stem portion 154 of the membrane 116 defines an opening 160 and includes a needle sealing portion 162 extending into the opening 160, with the needle sealing portion 162 configured to engage a portion of the needle 120. The membrane 116, the first component membrane 140, and the second component membrane 142 may be formed from an elastomeric material, although other suitable materials may be utilized.
[0034] In one aspect or embodiment, as shown in FIGS. 5 and 6, the convex surface 156 of the head portion 152 of the membrane 116 is at least partially positioned outside of the interior space 114 of the housing 106 and a portion of the second component membrane 142 is positioned outside of the passageway 138 of the component housing 130. Positioning the contact portions of the membrane 116 and the second component membrane 142 outside of the housing 106 and the component housing 130, respectively, provides access for a healthcare worker to disinfect those surfaces thereby minimizing contamination during fluid transfer using the system 100.
[0035] Referring again to FIGS. 3-6, in one aspect or embodiment, the secondary component 104 includes a luer connector 164. The secondary component 104 is shown as a patient connector. However, rather than providing the luer connector 164, the secondary component 104 may include other features and may be other components of a closed system transfer device or system, such as a vial adapter or IV bag spike. In one aspect or embodiment, the first connection interface 124 is an annular groove 166, and the second connection interface 144 is a cantilever arm 168. The cantilever arm 168 is configured to engage a portion of the housing 106 and move radially outward until a projection 170 of the cantilever arm 168 is received within the annular groove 166. The secondary component 104 may be rotatable relative to the syringe adapter 102 when the first connection interface 124 is connected to the second connection interface 144, which can inhibit twisting of any lines connected to the secondary component 104. The secondary component 104 is disconnected from the syringe adapter 102 by pressing a portion of the second connection interface 144, which lifts the projection 170 from the annular groove 166 such that the force of the biasing member 122 moves the membrane 116 back to the first position to aid in or provide for the separation of the secondary component 104 from the syringe adapter 102. The second connection interface 144 includes two cantilever arms 168, although one or more cantilever arms 168 may be utilized. [0036] Referring to FIGS. 7-9, a system 200 for closed transfer of fluids according to a further aspect or embodiment of the present application is shown. The system 200 is similar to the system 100 shown in FIGS. 3-6 and operates in a similar manner. The system 200 includes a syringe adapter 202 and a secondary component 204. The syringe adapter 202 includes a housing 206 having a first end 208 and a second end 210 positioned opposite the first end 208, with the housing 206 including a sidewall 212 defining an interior space 214, a membrane 216 received within the interior space 214 of the housing 206 and moveable from a first position within the housing 206 to a second position within the housing 206 spaced from the first position, a hub 218 positioned at the first end 208 of the housing 206 and configured to be connected to a syringe, a needle 220 connected to the hub 218, a biasing member 222 received within the housing 206, and a first connection interface 224 positioned on an outer surface of the housing 206. The secondary component 204 includes a component housing 226 having a first end 228 and a second end 230 positioned opposite the first end 228, with the component housing 226 having a sidewall 232 defining passageway 234, a component membrane 236 received within the passageway 234 of the component housing 226, and a second connection interface 238 positioned on an outer surface of the component housing 226. The second connection interface 238 is configured to engage the first connection interface 224 to secure the syringe adapter 202 to the secondary component 204. The needle 220 has a first end 240 and a second end 242 positioned opposite the first end 240, with the second end 242 of the needle 220 received within the membrane 216 when the membrane 216 is in the first position. The biasing member 222 biases the membrane 216 toward the first position. A portion of the membrane 216 extends outside of the interior space 214 of the housing 206 and a portion of the component membrane 236 extends outside of the passageway 234 of the component housing 226. Positioning the contact portions of the membrane 216 and the component membrane 236 outside of the housing 206 and the component housing 226, respectively, provides access for a healthcare worker to disinfect those surfaces thereby minimizing contamination during fluid transfer using the system.
[0037] Referring to FIGS. 8 and 9, in one aspect or embodiment, the syringe adapter 202 includes a membrane base 244 connected to the membrane 216, with the biasing member 222 in contact with the membrane base 244. The biasing member 222 is a compression spring, although other suitable biasing members may be utilized, including but not limited to a compressible material, hydraulic or pneumatic members, and/or flexible materials or shapes. The membrane 216 includes a head portion 252 and a stem portion 254 extending from the head portion 252, with the head portion 252 including a convex surface 256 and the stem portion 254 including a protrusion 258. The stem portion 254 of the membrane 216 is received within an opening defined by the membrane base 244, with the protrusion 258 of the stem portion 254 securing the membrane 216 to the membrane base 244. The stem portion 254 of the membrane 216 defines an opening 260 and includes a needle sealing portion 262 extending into the opening 260, with the needle sealing portion 262 configured to engage a portion of the needle 220. The convex surface 256 of the head portion 252 of the membrane 216 is at least partially positioned outside of the interior space 214 of the housing 206. The component membrane 236 includes a head portion 264 and a stem portion 266 extending from the head portion 264, with the head portion 264 including a convex surface 268. The convex surface 268 of the head portion 252 of the component membrane 236 is at least partially positioned outside of the passageway 234 of the component housing 226.
[0038] Referring again to FIGS. 7-9, in one aspect or embodiment, the first connection interface 224 is a recessed portion 270 and the second connection interface 238 is a cantilever arm 272. The hub 218 includes an extension 274 extending from the first end 208 of the housing 206 of the syringe adapter 202 toward the second end 210 of the housing 206 the syringe adapter 202, with the recessed portion 270 of the first connection interface 224 positioned on the extension 274. The hub 218 and the housing 206 of the syringe adapter 202 are formed separated and connected to each other. The hub 218 may be rotatable relative to the housing 206, although other suitable arrangements may be utilized. The cantilever arm 272 and the recessed portion 270 may operate in the same manners as the cantilever arm 272 and groove 166 discussed above in connection with the system 100 of FIGS. 3-6. In some aspects or embodiments, only the second connection interface 238 is a cantilever arm, only the first connection interface 224 is a cantilever arm, or both the first and second connection interfaces 224, 238 includes cantilever arms. [0039] Referring to FIGS. 10-12, a system 300 for closed transfer of fluids according to a further aspect or embodiment of the present application is shown. The system 300 is similar to the system 200 shown in FIGS. 7-9, includes a syringe adapter 302 and a secondary component 304, and operates in a similar manner. Like references numbers are utilized for like elements. Rather than providing the hub 218 separately from the housing 206 of the syringe adapter 302 as with the syringe adapter 202 of FIGS. 7-9, the hub 218 and the housing 206 of the syringe adapter 302 shown in FIGS. 10-12 may be formed integrally. As opposed to discrete cantilever arms 272 of the second connection interface 238 of FIGS. 7-9, the second connection interface 238 may be defined by an annular ring 306 defining a plurality of slits 308 that form a plurality of cantilever arms 310 that are received by an annular groove or recessed portion 312 of the syringe adapter 302. The component membrane 236 shown in FIGS. 7-9 is also thicker, such as twice as thick, than the component membrane 236 of the syringe adapter 202 shown in FIGS. 10-12 or the conventional mating connector 36 of FIGS. 1 and 2.
[0040] Referring to FIGS. 13 and 14, the systems 100, 200, 300 according to aspects or embodiments of the present application are smaller in length and diameter/width relative to the syringe adapter 10 and mating connector 36 shown in FIGS. 1 and 2. For example, the syringe adapter 10 and mating connector 36 of FIGS. 1 and 2 have a length LI and a width W1 when connected to each other. The system 100 of FIGS. 3-6 has a length L2 and a width W2 that are smaller than the length LI and the width W1 of the syringe adapter 10 and mating connector 36, respectively. The system 200 of FIGS. 7-9 has a length L3 and a minor width W3A and major width W3B that are smaller than the length LI and the width W1 of the syringe adapter 10 and mating connector 36, respectively. The minor width W3A and the length L3 of the system 200 is also smaller than the length L2 and the width W2 of the system 100 of FIGS. 3- 6. The system 300 of FIGS. 10-12 has a length L4 and width W4 that are smaller than the length LI and the width W1 of the syringe adapter 10 and mating connector 36, respectively. The length L4 is smaller than the lengths LI, L2, L3 and the width is smaller than the widths Wl, W2. A reduced footprint via smaller lengths and widths reduces material and packaging costs as well as storage space needed for the system.
[0041] While this disclosure has been described as having exemplary designs, the present disclosure can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims. To the extent possible, one or more features of any aspect or embodiment discussed above can be combined with one or more features of any other aspect or embodiment.

Claims

THE INVENTION CLAIMED IS
1. A system for closed transfer of fluids comprising: a syringe adapter comprising: a housing having a first end and a second end positioned opposite the first end, the housing includes a sidewall defining an interior space; a membrane at least partially received within the interior space of the housing and moveable from a first position within the housing to a second position within the housing spaced from the first position; a hub positioned at the first end of the housing and configured to be connected to a syringe; a needle connected to the needle hub, the needle having a first end and a second end positioned opposite the first end, the second end of the needle received within the membrane when membrane is in the first position; a biasing member received within the housing, the biasing member biasing the membrane toward the first position; and a first connection interface positioned on an outer surface of the housing; and a secondary component comprising: a component housing having a first end and a second end positioned opposite the first end, the component housing includes a sidewall defining passageway; a first component membrane at least partially received within the passageway; a second component membrane at least partially received within the passageway, the first component membrane is spaced from the second component membrane; and a second connection interface positioned on an outer surface of the component housing, the second connection interface configured to engage the first connection interface to secure the syringe adapter to the secondary component.
2. The system of claim 1, wherein a portion of the component housing is configured to be received within the interior space of the housing of the syringe adapter to move the membrane from the first position to the second position, and wherein the first connection interface is configured to engage the second connection interface when the portion of the component housing is positioned within the interior space of the housing of the syringe adapter with the membrane in the second position.
3. The system of claim 1, wherein the syringe adapter further comprises a membrane base connected to the membrane, and wherein the biasing member is in contact with the membrane base.
4. The system of claim 3, wherein the membrane comprises a head portion and a stem portion extending from the head portion, the head portion including a convex surface and the stem portion including a protrusion, and wherein the stem portion of the membrane is received within an opening defined by the membrane base, with the protrusion of the stem portion securing the membrane to the membrane base.
5. The system of claim 4, wherein the stem portion of the membrane defines an opening and includes a needle sealing portion extending into the opening, the needle sealing portion configured to engage a portion of the needle.
6. The system of claim 4, wherein the convex surface of the head portion of the membrane is at least partially positioned outside of the interior space of the housing.
7. The system of claim 1, wherein a portion of the second component membrane is positioned outside of the passageway of the component housing.
8. The system of claim 1, wherein the secondary component comprises a luer connector.
9. The system of claim 1, wherein the first connection interface comprises an annular groove, and wherein the second connection interface comprises a cantilever arm.
10. A system for closed transfer of fluids comprising: a syringe adapter comprising: a housing having a first end and a second end positioned opposite the first end, the housing includes a sidewall defining an interior space; a membrane received within the interior space of the housing and moveable from a first position within the housing to a second position within the housing spaced from the first position, a portion of the membrane extending outside of the interior space of the housing; a hub positioned at the first end of the housing and configured to be connected to a syringe; a needle connected to the hub, the needle having a first end and a second end positioned opposite the first end, the second end of the needle received within the membrane when membrane is in the first position; a biasing member received within the housing, the biasing member biasing the membrane toward the first position; and a first connection interface positioned on an outer surface of the housing; and a secondary component comprising: a component housing having a first end and a second end positioned opposite the first end, the component housing includes a sidewall defining passageway; a component membrane received within the passageway of the component, a portion of the component membrane extending outside of the passageway of the component housing; and a second connection interface positioned on an outer surface of the component housing, the second connection interface configured to engage the first connection interface to secure the syringe adapter to the secondary component.
11. The system of claim 10, wherein a portion of the component housing is configured to be received within the interior space of the housing of the syringe adapter to move the membrane from the first position to the second position, and wherein the first connection interface is configured to engage the second connection interface when the portion of the component housing is positioned within the interior space of the housing of the syringe adapter with the membrane in the second position.
12. The system of claim 10, wherein the syringe adapter further comprises a membrane base connected to the membrane, and wherein the biasing member is in contact with the membrane base.
13. The system of claim 12, wherein the membrane comprises a head portion and a stem portion extending from the head portion, the head portion including a convex surface and the stem portion including a protrusion, and wherein the stem portion of the membrane is received within an opening defined by the membrane base, with the protrusion of the stem portion securing the membrane to the membrane base.
14. The system of claim 13, wherein the stem portion of the membrane defines an opening and includes a needle sealing portion extending into the opening, the needle sealing portion configured to engage a portion of the needle.
15. The system of claim 13, wherein the convex surface of the head portion of the membrane is at least partially positioned outside of the interior space of the housing.
16. The system of claim 10, wherein the component membrane comprises a head portion and a stem portion extending from the head portion, the head portion including a convex surface.
17. The system of claim 16, wherein the convex surface of the head portion of the component membrane is at least partially positioned outside of the passageway of the component housing.
18. The system of claim 10, wherein the first connection interface comprises a recessed portion, and wherein the second connection interface comprises a cantilever arm.
19. The system of claim 18, wherein the hub comprises an extension extending from the first end of the housing of the syringe adapter toward the second end of the housing the syringe adapter, and wherein the recessed portion of the first connection interface is positioned on the extension.
20. The system of claim 10, wherein the hub and the housing of the syringe adapter are formed integrally.
PCT/US2025/011486 2024-01-15 2025-01-14 System for closed fluid transfer Pending WO2025155511A1 (en)

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US63/620,962 2024-01-15

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US20120226238A1 (en) * 2009-06-02 2012-09-06 Sanofi-Aventis Deutschland Gmbh Medicated module with bypass and needle guard
WO2022207560A1 (en) * 2021-03-31 2022-10-06 B. Braun Melsungen Ag Fluid transfer device and closed medicine transfer system
US20220331574A1 (en) * 2021-04-19 2022-10-20 Becton, Dickinson And Company Multi-Layer Self-Healing Membrane for Septal Closure of a Medical Device
US20220339069A1 (en) * 2018-03-20 2022-10-27 Becton Dickinson and Company Limited Connection Arrangement for Closed System Transfer of Fluids

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120226238A1 (en) * 2009-06-02 2012-09-06 Sanofi-Aventis Deutschland Gmbh Medicated module with bypass and needle guard
US20120179128A1 (en) * 2009-10-28 2012-07-12 Terumo Kabushiki Kaisha Connector assembly
US20220339069A1 (en) * 2018-03-20 2022-10-27 Becton Dickinson and Company Limited Connection Arrangement for Closed System Transfer of Fluids
WO2022207560A1 (en) * 2021-03-31 2022-10-06 B. Braun Melsungen Ag Fluid transfer device and closed medicine transfer system
US20220331574A1 (en) * 2021-04-19 2022-10-20 Becton, Dickinson And Company Multi-Layer Self-Healing Membrane for Septal Closure of a Medical Device

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