WO2024182637A2 - Raccords pour la prévention ou la réduction de la contamination dans des environnements de traitement - Google Patents

Raccords pour la prévention ou la réduction de la contamination dans des environnements de traitement Download PDF

Info

Publication number
WO2024182637A2
WO2024182637A2 PCT/US2024/017920 US2024017920W WO2024182637A2 WO 2024182637 A2 WO2024182637 A2 WO 2024182637A2 US 2024017920 W US2024017920 W US 2024017920W WO 2024182637 A2 WO2024182637 A2 WO 2024182637A2
Authority
WO
WIPO (PCT)
Prior art keywords
socket
plug
connector
seal
snap
Prior art date
Application number
PCT/US2024/017920
Other languages
English (en)
Inventor
Alexander Charles GRAFF
Original Assignee
National Resilience, Inc.
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 National Resilience, Inc. filed Critical National Resilience, Inc.
Publication of WO2024182637A2 publication Critical patent/WO2024182637A2/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/56—Labware specially adapted for transferring fluids
    • B01L3/563—Joints or fittings ; Separable fluid transfer means to transfer fluids between at least two containers, e.g. connectors
    • 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
    • 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
    • A61M39/1011—Locking means for securing connection; Additional tamper safeties

Definitions

  • the present disclosure is directed to connectors that prevent, or minimize, contamination in fluidic pathways during the connection and/or disconnection process, and that simplify these processes relative to conventional devices and methods.
  • a connector comprises: a socket comprising a first fluidic pathway; and a plug comprising a second fluidic pathway; wherein the socket and the plug are (1) releasably couplable to connect the first fluidic pathway with the second fluidic pathway, and (2) decouplable to disconnect the first fluidic pathway from the second fluidic pathway, wherein contamination in each of the first fluidic pathway and the second fluidic pathway is prevented, or minimized, during and/or post disconnection.
  • the socket can be configured to be attached to a cartridge.
  • the plug can be configured to be attached to a storage container.
  • the connector further comprises a shroud configured to couple to the socket and the plug, wherein the socket and the plug are releasably couplable via the shroud.
  • the socket comprises a socket seal defining at least in part the first fluidic pathway
  • the plug comprises a plug seal defining at least in part the second fluidic pathway.
  • the socket seal and the plug seal are each compressible. The socket seal and the plug seal are each in a compressed state when the socket and the plug are releasably coupled together. The socket seal may be in the compressed state due to a flange of the plug exerting a compressive force on the socket seal.
  • the plug seal may be in the compressed state due to a flange of the socket exerting a compressive force on the plug seal.
  • the compressed state of the socket seal causes a slit in the socket seal to widen and permit access to the first fluidic pathway.
  • the compressed state of the plug seal causes a slit in the plug seal to widen and permit access to the second fluidic pathway.
  • the socket seal and the plug seal are each in a neutral state when the socket and the plug are decoupled from each other.
  • the socket seal may be in the neutral state due to removal of a compressive force exerted by a flange of the plug on the socket seal.
  • the plug seal may be in the neutral state due to removal of a compressive force exerted by a flange of the socket on the plug seal.
  • the neutral state of the socket seal causes a slit of the socket seal to close and inhibit access to the first fluidic pathway, thereby preventing, or minimizing, contamination of the first fluidic pathway.
  • the neutral state of the plug seal causes a slit of the plug seal to close and inhibit access to the second fluidic pathway, thereby preventing, or minimizing, contamination of the second fluidic pathway.
  • the socket seal and the plug seal are configured to be compressed and/or de-compressed (to a neutral state) in a stepwise or sequential manner.
  • the plug seal may be compressed to open the second fluidic pathway (e.g., for acceptance of a sample from the first fluidic pathway) before the socket seal is compressed to open the first fluidic pathway (e.g., for releasing the sample to the second fluidic pathway).
  • the socket seal may return to its neutral (de-compressed) state to close the first fluidic pathway (e.g., to clear any dead volume from spaces within the connector) before the plug seal returns to its neutral (de-compressed) state to close the second fluidic pathway (e.g., to seal the plug from exposure to surrounding environment).
  • the socket seal and the plug seal are cylindrical.
  • the socket and the plug are configured to prevent, or minimize, contamination in each of the first fluidic pathway and the second fluidic pathway during and/or post disconnection.
  • the plug is configured to be decoupled from the socket without requiring a tool to decouple or separate the socket and the plug into two distinct pieces.
  • the socket and/or the plug comprise one or more snap features.
  • the one or more snap features are configured to allow the plug to be releasably coupled to the socket.
  • the one or more snap features comprise one or more wedges and one or more corresponding torsion snaps.
  • the socket comprises the one or more wedges and the plug comprises the corresponding one or more torsion snaps.
  • the one or more wedges are circumferentially distributed around the socket and the corresponding one or more torsion snaps are circumferentially distributed around the plug.
  • the socket and/or the shroud comprise one or more snap features, wherein the one or more snap features are configured to allow the shroud to be releasably coupled to the socket.
  • the shroud comprises one or more locking snap features
  • the plug comprises one or more mating features. The one or more locking snap features and the one or more mating features are configured to couple the plug with the shroud. In some embodiments, a first force required to decouple the plug from the socket, is less than a second force required to decouple the plug from the shroud.
  • the socket may be configured to remain on a cartridge when the plug is being decoupled from the socket.
  • the socket, the plug and/or the shroud are disposable and configured for single use.
  • a biomanufacturing system comprises: a cartridge comprising one or more ports; one or more storage containers for collecting a sample from the cartridge; and one or more connectors configured to connect the one or more storage containers with the one or more ports on the cartridge, wherein each connector comprises: a socket comprising a first fluidic pathway, wherein the socket is configured to attach to a port on the cartridge; and a plug comprising a second fluidic pathway, wherein the plug is configured to attach to a storage container; wherein the socket and the plug for each connector are (1) releasably couplable to connect the first fluidic pathway with the second fluidic pathway, and (2) decouplable to disconnect the first fluidic pathway from the second fluidic pathway, preventing, or minimizing, contamination in each of the first fluidic pathway and the second fluidic pathway during and/or post disconnection.
  • the system further comprises a shroud configured to couple to the socket and the plug, wherein the socket and the plug are releasably couplable via the shroud.
  • the cartridge is configured to be used for automated cell therapy manufacturing.
  • the plug(s) of the one or more connectors are molded separately from the one or more storage containers, and coupled to the one or more storage containers via a bonding process.
  • the ports are connected to a bioreactor.
  • a two-stage snap connector comprises: a plug comprising one or more snap extrusions, wherein at least one of the one or more snap extrusions comprises a cut portion; and a socket comprising one or more openings corresponding to the one or more snap extrusions and one or more snap levers extending into said openings, wherein the plug and the socket are configured to reversibly couple to one another in a first stage when the one or more snap extrusions are traversed into the one or more openings such that the one or more snap levers snap into the at least one cut portion of the one or more snap extrusions, and wherein the plug and the socket are configured to irreversibly couple to each other in a second stage when the one or more snap extrusions are fully traversed into the one or more openings such that the one or more snap levers lock onto a flange of the one or more snap extrusions.
  • the plug comprises a spike having a first fluidic pathway.
  • the socket comprises a septum, wherein the septum is configured to seal a second fluidic pathway.
  • the first stage causes the spike to traverse towards the septum.
  • the second stage causes the spike to pierce the septum.
  • the septum is pierced to allow fluid to flow through the first fluidic pathway and the second fluidic pathway.
  • the fluid may flow through the first fluidic pathway and the second fluidic pathway with aid of gravity and/or a pump.
  • the socket may be connected to a cartridge, and the fluid may be transported to the cartridge through the first fluidic pathway and the second fluidic pathway.
  • the socket comprises one or more channels comprising the one or more openings, wherein the one or more channels and corresponding snap extrusions are configured to provide one or more keying features for coupling the socket and the plug.
  • FIG. 1 shows an exemplary system including several connectors, in accordance with some embodiments
  • FIG. 2 shows an exploded view of an exemplary connector, in accordance with some embodiments
  • FIG. 3 shows different views of an exemplary plug, in accordance with some embodiments
  • FIG. 4 shows different views of an exemplary shroud, in accordance with some embodiments
  • FIG. 5 shows a cross-sectional view of an exemplary connector in its disconnected/separated state, in accordance with some embodiments
  • FIG. 6 shows an exemplary workflow for disconnecting a storage container from a cartridge (e.g., after filling the storage container with a sample from the cartridge), in accordance with some embodiments;
  • FIG. 7 shows cross-sectional views of an exemplary connector before, during and after the disconnection process, in accordance with some embodiments
  • FIG. 8 shows various views of an exemplary connector in a connected state (i.e., with open fluid path), in accordance with some embodiments
  • FIG. 9 shows various views of an exemplary connector during the disconnection process, in accordance with some embodiments.
  • FIG. 10 shows various views of an exemplary connector in a disconnected state, in accordance with some embodiments.
  • FIG. 11 shows various views of an exemplary socket seal and a plug seal in a compressed state and a neutral state, in accordance with some embodiments
  • FIG. 12 shows various views of torsion snap features on an exemplary shroud, and wedges on an exemplary socket, as well as cross-sectional views of the torsion snap features being deflected by the wedges during disconnection, in accordance with some embodiments;
  • FIG. 13 shows an exemplary two-stage snap connector, in accordance with some embodiments.
  • FIG. 14 shows various views of an exemplary plug of the two-stage snap connector of FIG. 13, in accordance with some embodiments
  • FIG. 15 shows various views of an exemplary socket of the two-stage snap connector of FIG. 13, in accordance with some embodiments;
  • FIG. 16 shows a first stage of the two-stage snap connection, in accordance with some embodiments.
  • FIG. 17 shows a second stage of the two-stage snap connection, in accordance with some embodiments.
  • connectors that prevent, or minimize, contamination during a connection and/or disconnection process, and that may simplify these processes relative to conventional devices and methods.
  • the connectors described herein can prevent, or minimize, contamination of fluidic pathways during and/or after the connection/disconnection process (e.g., in a biomanufacturing system). Additionally, the connectors described herein are designed/configured to prevent an operator from accidentally or intentionally contaminating the fluidic pathways during and/or after the connection/disconnection process.
  • FIG. 1 shows a system 100 including several connectors, in accordance with some embodiments.
  • the system 100 may be used in biopharmaceutical research and/or manufacturing (biopharma) environment, for example.
  • the biomanufacturing environment may be a cell therapy manufacturing system (e.g., an automated CAR-T cell therapy manufacturing system).
  • the system 100 may include a cartridge 102 and one or more storage containers 104.
  • the cartridge 102 may be, for example, a (bio)-manufacturing consumable.
  • the cartridge 102 may be inserted into an instrument (not shown), for example.
  • the cartridge 102 may include one or more ports (not shown).
  • a storage container 104 may be operably coupled to a port of the cartridge 102 via a connector 106.
  • a storage container 104 can be configured to collect a sample from the cartridge 102.
  • four storage containers 104 connected to the cartridge 102 are shown, although any number of storage containers can be connected, for example, depending on the size of the cartridge and/or scale of the system 100 (e.g., the application in which the system is used, such as cell therapy manufacturing, bio process development, research, etc.).
  • Storage container(s) 104 can be used to store a sample collected through a corresponding port on the cartridge 102.
  • a connector 106 can be configured to connect the corresponding storage container 104 with the corresponding port on the cartridge 102, and to enable fluidic communication between the cartridge 102 and the storage container 104.
  • Connector(s) 106 are configured such that storage container(s) 104 can be disconnected and removed from the cartridge 102, for example, after a sample was collected in the storage container(s) 104.
  • the system and its components for example prior to connecting the storage container 104 to the cartridge 102, can be sterilized such that the components are substantially free of contamination.
  • the connectors 106 can be configured to prevent, or minimize, contamination in different fluidic pathways (e.g., a fluidic pathway to the cartridge 102 and/or a fluidic pathway to the storage container 104) during and/or post disconnection.
  • the disconnection corresponds to removal of a storage container 104 from the cartridge 102, for example, after the storage container 104 has been filled with a sample from the cartridge 102.
  • FIG. 2 shows an exploded view of a connector 106, in accordance with some embodiments.
  • the connector 106 can include a socket 110 and a plug 120.
  • the connector 106 can further include a shroud 130 (the features described herein with respect to the shroud can also be implemented into the plug and/or socket).
  • the socket 110 can be configured to be attached to the cartridge 102.
  • the socket 110 may be molded separately from the cartridge 102, and attached to the cartridge 102 (for example, using one or more snap fits).
  • the socket 110 may be molded together as part of the cartridge 102, or otherwise permanently attached.
  • the plug 120 can be configured to be attached to a storage container 104.
  • the plug 120 may be molded separately and subsequently bonded to the storage container 104.
  • the plug 120 may be configured to be screwed onto the storage container 104, or otherwise attached.
  • the shroud 130 can be configured to couple with the socket 110 and the plug 120, and to facilitate connection/disconnection between the socket 110 and the plug 120.
  • the connector 106 can include a socket seal 114 and a plug seal 124.
  • the socket 110 may comprise a fluidic pathway 112 (which is at least partially defined by or extends through a lumen within the socket seal 114), and the plug 120 may comprise a fluidic pathway 122 (which is at least partially defined by or extends through a lumen within the plug seal 124).
  • the lumens in the socket seal 114 and the plug seal 124 are described in further detail with reference to FIG. 11.
  • the socket 110 and the plug 120 can be releasably coupled directly, or via the shroud 130, to connect the fluidic pathway 112 with the fluidic pathway 122.
  • the socket 110 and the plug 120 can also be decoupled to disconnect the fluidic pathway 112 from the fluidic pathway 122, while preventing, or minimizing, contamination in each of the fluidic pathways 112 and 122 during and/or post disconnection.
  • the plug 120 (either directly or via the shroud 130) can be decoupled from the socket 110 automatically, semi-automatically, or manually, while preventing, or minimizing, contamination in each of the fluidic pathways 112 and 122.
  • the manual, semi-automatic, or automatic coupling/decoupling enabled by the disclosed connectors improves over conventional connectors providing advantages, such as forming a consistent and reliable coupling/decoupling process that is independent of dexterity and experience level among operators. Further, the automatic or semi-automatic coupling/decoupling process is independent of varying individual operator response time.
  • the plug 120 (either directly or via the shroud 130) can be decoupled from the socket 110 without requiring a tool to decouple or separate the socket 110 and the plug 120 into two distinct pieces.
  • tools e.g., specialized tools for engaging or disengaging connections
  • the connector 106 can eliminate the use of specialized tools, which can provide cost savings and/or greater efficiency in processing time and/or speed.
  • the plug 120 (either directly or via the shroud 130) can be decoupled from the socket 110 automatically, semi-automatically, or manually within a short time period, while preventing, or minimizing, contamination in each of the fluidic pathways 112 and 122. This is advantageous from a manufacturing/process efficiency perspective, since it enables the storage containers 104 to be promptly and quickly removed from the cartridge 102 once the storage containers 104 have been filled with a sample.
  • the socket seal 114 and the plug seal 124 are each compressible, as described and shown, for example, with respect to FIGs. 7-11.
  • the socket 110 can include a socket flange 118.
  • the socket flange 118 may have a substantially flat surface.
  • the socket flange 118 may be in the form of an annular flat surface/rim on a distal end of the socket 110, for example as shown in FIG. 2.
  • the socket flange 118 can exert a compressive force on the plug seal 124, which causes the plug seal 124 to transition to a compressed state when the socket 110 and the plug 120 are coupled together, as described and shown, for example, in Part A of FIG. 7 and FIG. 8.
  • the plug 120 or shroud 130 can comprise one or more torsion snap features 132.
  • the socket 110 can comprise one or more wedges 116, for example a plurality of wedges 116 circumferentially distributed around the socket 110.
  • the wedges 116 and the torsion snap features 132 can be configured to allow the plug 120, or the shroud 130, to be releasably coupled to the socket 110.
  • socket 110 and the plug 120, or shroud 130 can be configured to provide one or more keying features to ensure that correct components are connected to one another.
  • a socket 110 can include a number of channels (e.g., 1, 2, 3, 4, 5, etc.) that correspond to a number of extrusions (e.g., 1, 2, 3, 4, 5, etc.) of a plug 120, or shroud 130, to be connected to the socket 110.
  • a number of channels e.g., 1, 2, 3, 4, 5, etc.
  • extrusions e.g., 1, 2, 3, 4, 5, etc.
  • the shroud 130 can comprise locking snap features (e.g., locking snap features 134) and the plug 120 can comprise mating features (e.g., mating features 126).
  • the mating features 126 may be in the form of openings, that are configured such that the locking snap features 134 can snap onto and couple with the mating features 126.
  • the locking snap features 134 on the shroud 130, and the mating features 126 on the plug 120 can be configured to couple the plug 120 with the shroud 130 (for example, either creating an irreversible coupling between the plug 120 and the shroud 130, or a coupling that cannot easily be disconnected).
  • an exemplary connection using a snap feature is described herein, any other connection between the plug and shroud also is contemplated, such as clips, latches, etc.
  • the socket 110, the plug 120, and/or the shroud 130 are disposable and/or configured for single use. For example, after the plug 120 with a storage container 104 has been disconnected from the socket 110 (either directly or via the shroud 130), the plug 120 may be subsequently removed from the storage container 104 and disposed.
  • FIG. 3 shows various views of a plug 120, in accordance with some embodiments.
  • the plug 120 may comprise a fluidic pathway 122 (which is at least partially defined by or extends through a lumen of the plug seal 124).
  • the plug 120 can include one or more mating features 126.
  • the mating feature(s) 126 on the plug 120, and the locking snap feature(s) 134 on the shroud 130 can be configured to couple the plug 120 with the shroud 130 (for example, either creating an irreversible coupling between the plug 120 and the shroud 130, or a coupling that cannot easily be disconnected).
  • the plug 120 can comprise first opening 123, a second opening 127, and a lumen 121.
  • the lumen 121 can be configured to accommodate the plug seal 124.
  • the plug 120 may also comprise an extruded portion 129, which can be configured to couple, for example, to a storage container 104.
  • an internal or external surface of the extruded portion 129 can be threaded, to couple with corresponding mating threads on a storage container 104.
  • the plug 120 can be molded separately from a storage container 104, and can be coupled to the storage container 104 (e.g., through a bonding process).
  • the plug 120 further can comprise a plug flange 128.
  • the plug flange 128 may have a substantially flat surface.
  • the plug flange 128 can exert a compressive force on a socket seal 114, which causes the socket seal 114 to transition to a compressed state when the socket 110 and the plug 120 are coupled together, as described herein and shown in Part A of FIG. 7 and FIG. 8.
  • FIG. 4 shows various views of a shroud 130, in accordance with some embodiments (the features described with respect to the shroud 130 can also be implemented into the plug 120 and/or the socket 110).
  • the shroud 130 can comprise one or more torsion snap features 132, and one or more locking snap features 134.
  • the shroud 130 may comprise a cavity 131 having an internal bottom surface 133.
  • the torsion snap features 132 may be arranged circumferentially around the internal bottom surface
  • the shroud 130 comprises four sets of torsion snap features 132, that are evenly spaced apart from one another. Any number of torsion snap features, in any spatial configuration relative to one another, may be contemplated (for example, to customize the ease of release of the shroud 130 from the socket 110).
  • the torsion snap features 132 may be prefabricated as part of the shroud 130. As described herein, the torsion snap features 132 on the shroud 130, and the wedges 116 on the socket 110, are configured to allow the shroud 130 with the plug 120 to be releasably coupled to the socket 110.
  • any other connection between the socket and plug (or shroud) also is contemplated, such as such as annular snap-fits, cantilever snap-fits, spring clips, mechanical clamps or locks.
  • the locking snap feature(s) 134 on the shroud 130, and the mating feature(s) 126 on the plug 120 can be configured to couple the plug 120 with the shroud 130 (for example, either creating an irreversible coupling between the plug 120 and the shroud 130, or a coupling cannot easily be disconnected).
  • the locking snap features 134 may have a wide cantilevered structure, and may be spaced opposite each other.
  • FIG. 5 shows a cross-sectional view of a connector 106 in its disconnected/separated state, in accordance with some embodiments.
  • the socket 110 can remain on the cartridge 102, while the plug 120 (and the shroud 130 if used) can remain, for example, with storage container 104.
  • Contamination in each of the fluidic pathway 112 and the fluidic pathway 122 can be prevented, or minimized, during and/or post disconnection.
  • access to the fluidic pathway 112 in the socket 110 e.g., to the cartridge 102
  • access to the fluidic pathway 122 in the plug 120 e.g., to the storage container 104
  • the plug seal 124 is closed/prevented by the plug seal 124.
  • the connector 106 can be configured to prevent the plug from being re-attached after disconnecting the plug from the socket, e.g., to avoid inadvertently releasing a collected sample.
  • the connector 106 can be configured to prevent inadvertent compression of the plug seal and/or the socket seal, for example, by added features protecting the seals and/or the geometry (e.g., the size or shape) of the of the components.
  • the disconnection process, along with the operational mechanics of the socket seal 114 and the plug seal 124, will be described as follows with reference to FIGs. 6-12.
  • FIG. 6 shows a workflow for disconnecting a plug (e.g., with storage container 104) from a socket (e.g., coupled with cartridge 102), in accordance with some embodiments (e.g., after a storage container 104 has been filled with a sample from a cartridge 102).
  • empty storage containers 104 can be initially coupled to a cartridge 102 via connectors 106, for collection of a sample through ports on the cartridge 102.
  • connectors 106 storage containers 104 can be disconnected/removed from the cartridge 102 (e.g., when the storage container 104 has been filled with a sample), while preventing contamination of the fluidic pathways.
  • storage containers 104 can be removed from the cartridge 102 automatically, semi -automatically, or manually once they have been filled, or after a certain time has elapsed.
  • the storage containers 104 can be removed from the cartridge 102 /sequentially, in parallel, or in one or more batches.
  • the socket 110 remains on the cartridge 102, while the plug 120 and the shroud 130 remain on the storage container 104 (see for example FIG. 6, Disconnection Complete).
  • a plug 120, shroud 130 (if used), and/or storage container 104 may be pre-connected to a socket 110 on the cartridge 102.
  • the connector 106 comprising socket 110, plug 120 and shroud 130 (if used)
  • storage container 104 may be sterilized using industry-standard sterilization methods (e.g., gamma radiation, ethylene oxide gas, etc.) for manufacturing consumables.
  • An instrument can be configured to control the cartridge 102 to (automatically) fill the storage containers 104 with samples from a bioreactor during a manufacturing run.
  • the storage containers 104 may be filled either sequentially, in parallel, or in one or more batches. After the storage containers 104 have been filled, they can be removed from the cartridge 102 by disconnecting the shroud 130 / plug 120 from the socket 110.
  • FIG. 7 shows cross-section views of a connector 106 before, during and after the disconnection process, in accordance with some embodiments.
  • Part A of FIG. 7 is shown in further detail in FIG. 8, which shows various views of the system 100 in a connected state, with the socket seal 114 and the plug seal 124 in a compressed state, and the fluidic pathway 112 connected with the fluidic pathway 122.
  • Part B of FIG. 7 is shown in further detail in FIG. 9, which shows various views of the system 100 during the disconnection process.
  • Part C of FIG. 7 is shown in further detail in FIG. 10, which shows various views of the system 100 in a disconnected state.
  • the socket seal 114 and the pug seal 124 are in a compressed state, which enables the fluidic pathway 112 to connect at 140 with the fluidic pathway 122, thus allowing, for example, a sample to flow from the cartridge 102 to the storage container 104.
  • the socket seal 114 is in the compressed state due to the plug flange 128 (see also FIG. 3 for location of the plug flange 128) exerting a compressive force on the socket seal 114. Referring to the compressed seals shown in FIG.
  • a slit 115 in the socket seal 114 is widened to permit access to the fluidic pathway 112.
  • the plug seal 124 is in the compressed state due to the socket flange 118 (see FIG. 2 for location of the socket flange 118) exerting a compressive force on the plug seal 124.
  • a slit 125 in the socket seal 124 is widened to permit access to the fluidic pathway 122.
  • the disconnection process begins (e.g., when the storage container 104 has been filled with a sample from the cartridge 102), whereby the plug 120 (and shroud 130 if used) is traversed away from the cartridge 102.
  • the traversing motion causes wedges 116 on the socket 110 to deflect the torsion snap features 132 on the shroud 130, thereby releasing plug 120 (or the shroud 130 if used) from the socket 110.
  • the traversing motion also causes the socket seal 114 and the plug seal 124 to transition from the compressed state to a neutral state as the socket 110 and the plug 120 are being decoupled from one another.
  • the socket seal 114 transitions to the neutral state due to removal of the compressive force exerted by the plug flange 128 on the socket seal 114.
  • the slit 115 of the socket seal 114 closes and inhibits access to the fluidic pathway 112 at 142 (corresponding to “socket disconnect”), thereby preventing, or minimizing, contamination of the fluidic pathway 112.
  • the plug seal 124 further transitions to the neutral state, due to removal of a compressive force exerted by the socket flange 118 on the plug seal 124.
  • the seals in neutral state shown in FIG. 11 when the plug seal 124 is in the neutral state, the slit 125 of the socket seal 124 closes and inhibits access to the fluidic pathway 122 at 144 (corresponding to “plug disconnect”), thereby preventing, or minimizing, contamination of the fluidic pathway 122.
  • the socket 110 is configured to remain on the cartridge 102 while the plug 120 and the shroud 130 are being decoupled from the socket 110. The disconnection is complete when the plug 120 is fully disconnected from the socket 110, which inhibits/closes access to the fluidic pathway 112 and the fluidic pathway 122, thereby preventing, or minimizing, contamination in each of those fluidic pathways.
  • Part D of FIG. 7 shows the shroud 130 / plug 120 fully decoupled from the socket 110, such that there is no physical contact between the shroud 130 / plug 120 with the socket 110.
  • the filled storage container 104 (with the plug 120 and shroud 130 attached thereto) may be transported to another location for further use and/or processing of the collected sample, for example.
  • the socket seal 114 and the plug seal 124 are configured to be compressed and/or de-compressed in a stepwise or sequential manner.
  • the plug seal 124 may be initially compressed to open the fluidic pathway 122 to prepare for acceptance of fluid flow (e.g., a sample) from the fluidic pathway 112, before the socket seal 114 is compressed to open the fluidic pathway 112 for releasing the sample to the fluidic pathway 122.
  • the socket seal 114 may return to its neutral (de-compressed) state to close the fluidic pathway 112 (e.g., to clear any dead volume from spaces within the connector 106) before the plug seal 124 returns to its neutral (de-compressed) state to close the fluidic pathway 122 (e.g., to seal the plug 120 and a storage container 104 attached thereto from exposure to a surrounding environment).
  • the socket seal 114 and the plug seal 124 can have a variety of shapes and/or sizes.
  • the socket seal 114 and the plug seal 124 can be cylindrical.
  • the socket seal 114 can have a lumen 146 for defining at least a portion of the fluidic pathway 112.
  • the plug seal 124 can have a lumen 148 defining at least a portion of the fluidic pathway 122.
  • an outer diameter of the socket seal 114 can be less than an outer diameter of the plug seal 124.
  • an outer diameter of the socket seal 114 can be the same as, or greater than an outer diameter of the plug seal 124.
  • an inner diameter of the socket seal 114 can be less than an inner diameter of the plug seal 124, for example as shown in FIG. 11. In some implementations, an inner diameter of the socket seal 114 can be same as, or greater than an inner diameter of the plug seal 124.
  • the inner diameter of the socket seal 114 can be a diameter of the lumen 146.
  • the inner diameter of the plug seal 124 can be a diameter of the lumen 148.
  • a diameter of the lumen 146 can be substantially uniform throughout a length of the lumen 146. In some implementations, a diameter of the lumen 146 can vary along a length of the lumen 146 (e.g., having a tapered or sloping profile). In some implementations, a diameter of the lumen 148 can be substantially uniform throughout a length of the lumen 148. In some implementations, a diameter of the lumen 148 can vary along a length of the lumen 148 (e.g., having a tapered or sloping profile).
  • the socket seal 114 and the plug seal 124 can have substantially a same size (e.g., height or length) when the socket seal 114 and the plug seal 124 are each in the compressed state. In some implementations, the socket seal 114 and the plug seal 124 can have different sizes (e.g., height or length) when the socket seal 114 and the plug seal 124 are each in the compressed state.
  • the socket seal 114 and the plug seal 124 can have different sizes (e.g., height or length) when the socket seal 114 and the plug seal 124 are each in the neutral state.
  • the socket seal 114 can have a smaller size (e.g., height or length) compared to the plug seal 124 when the socket seal 114 and the plug seal 124 are each in the neutral state, such as shown in FIG. 11.
  • the socket seal 114 can have a larger size (e.g., height or length) compared to the plug seal 124 when the socket seal 114 and the plug seal 124 are each in the neutral state.
  • the socket seal 114 and the plug seal 124 can have substantially the same size (e.g., height or length) when the socket seal 114 and the plug seal 124 are each in the neutral state.
  • the socket seal 114 and the plug seal 124 can have the same stiffness or different stiffness.
  • a spring constant ki of the socket seal 114 can be less than a spring constant k2 of the plug seal 124.
  • a spring constant ki of the socket seal 114 can be greater than a spring constant k2 of the plug seal 124.
  • the stiffness of the socket seal 114 and the plug seal 124 can be configured/customized based on a size and/or shape of the socket 110 and the plug 120, to ensure that the slits 115/125 in the seals 114/124 open sufficiently to permit fluidic flow, and to fully close to inhibit/prevent fluidic flow when the seals 114/124 transition from the compressed state to the neutral state.
  • the double compression sealing scheme described herein can enable ease of disconnection.
  • conventional disconnection devices and methods designed to prevent contamination of fluidic pathways tend to be complex and intensive, and often require actuation to ensure that a seal is maintained before two halves of a conventional connector are pulled apart/separated.
  • the connectors (e.g., connector 106) described herein can address the above issues, by quickly generating a seal when disconnection occurs. This is achieved, for example, by providing adequate elasticity and spring force in the seals 114/124 to quickly close the fluidic pathways 112/122 when the compressed seals 114/124 return to their neutral state during disconnection.
  • the connectors e.g., connector 106 can simplify the disconnection process, since an operator merely has to pull the plug 120/shroud 130 away from the socket 110, to seal the socket 110 and the plug 120, and disconnect and remove the storage container 104 from the cartridge 102, for example.
  • FIG. 12 shows magnified views of exemplary torsion snap features 132 on the shroud 130 and the wedges 116 on the socket 110, in accordance with some embodiments (as noted previously, any features described with respect to the shroud 130 can be implemented into the plug 120 and/or the socket 110, for example, when shroud 130 is not used).
  • FIG. 12 also shows cross-sectional views of the torsion snap features 132 being deflected by the wedges 116, to permit the plug 120 with the shroud 130 to decouple from the socket 110 when the plug 120/shroud 130 are lifted off the socket 110.
  • the socket 110 comprises one or more wedges 116, for example a plurality of wedges 116 circumferentially distributed around the socket 110 at a port on the cartridge 102.
  • the shroud 130 comprises one or more torsion snap features 132 and locking snap features 134.
  • the wedges 116 and the torsion snap features 132 can be configured to allow the shroud 130 with the plug 120 to be releasably coupled to the socket 110.
  • the torsion snap features 132 can extend below an extruded portion of the wedges 116, to secure the shroud 130 with the plug 120 to the socket 110.
  • the torsion snap features 132 deflect as they move past the top extruded portion of the wedges 116, which permits the shroud 130 with the plug 120 to disconnect and traverse away from the socket 110.
  • a stiffness and/or design of the torsion snap features 132 and locking snap features 134 can be configured such that a first force required to decouple the shroud 130 with the plug 120 from the socket 110, is less than a second force required to decouple the plug 120 from the shroud 130.
  • the locking snap features 134 on the shroud 130, and the mating features 126 on the plug 120 are configured to couple the plug 120 with the shroud 130 (for example, either creating an irreversible coupling between the plug 120 and the shroud 130, or a coupling that cannot be easily disconnected). Accordingly, the locking snap features 134 do not deflect (or deflect by a small amount) as the shroud 130 with the plug 120 are being disconnected from the socket 110, which keeps the plug 120 coupled to the shroud 130 during the disconnection process.
  • Disconnection is complete when the plug 120 is disconnected from the socket 110, which inhibits/prevents access to the fluidic pathway 112 and the fluidic pathway 122 (by the socket seal 114 and the plug seal 124 respectively) and prevents, or minimizes, contamination in each fluidic pathway 112/122, as described herein.
  • the torsion snap features 132 on the shroud 130 revert to their original undeflected state when disconnection is complete.
  • the connector 106 can be configured to prevent reconnecting the plug 120 to the socket 110 after disconnection is complete.
  • FIG. 13 shows an exemplary two-stage snap connector 200, in accordance with some embodiments.
  • the connector 200 comprises a plug 210 and a socket 220.
  • the plug 210 may be a male connector
  • the socket 220 may be a female connector.
  • FIG. 14 shows various views of the exemplary plug 210
  • FIG. 15 shows various views of the exemplary socket 220.
  • the plug 210 can comprise one or more snap extrusions 212.
  • Each of the snap extrusions 212 can comprise a cut portion 214 and a flange 215.
  • the plug 210 can further comprise a spike 216 having a fluidic pathway 219.
  • the socket 220 can comprise one or more channels 221, opening(s) 222 within the channels 221, and snap lever(s) 224 extending into the opening(s) 222.
  • the locations of the channel (s) 221 in the socket 220 correspond to the locations of the snap extrusion(s) 212 of the plug 210, allowing for the snap extrusion(s) 212 of the plug 210 to be traversed into the channel(s) 221 of the socket 220.
  • the socket 220 can include a septum 226 that seals a fluidic pathway 223 through the socket 220.
  • the channel(s) 221 of the socket 220 and snap extrusions 212 of the plug 210 can be configured to provide keying features to ensure that correct components are connected to one another.
  • a socket 220 can include a number of channels 221 (e.g., 1, 2, 3, 4, 5, etc.) that correspond to a number of snap extrusions 212 (e.g., 1, 2, 3, 4, 5, etc.) of a plug 210 to be connected to the socket 220.
  • Such keying features can ensure that only correct connections are made, for example, that the correct reagent vials are connected to the correct socket.
  • the plug 210 can be coupled to, for example, a device, container, tube, etc., via portion 218.
  • the socket 220 can be coupled to, for example, a device, container, tube, etc., via portion 228.
  • Portions 218 and 228 can be coupled via any connection scheme used for fluidic pathways.
  • FIGs. 16 and 17 show the connection process of the plug 210 and socket 220.
  • FIG. 16 shows a first stage of the exemplary two-stage snap connection, in accordance with some embodiments.
  • the snap extrusion(s) 212 of the plug 210 are traversed into corresponding channel(s) 221 of the socket 220 such that the snap lever(s) 224 in the opening(s) 222 snap onto the cut portion(s) 214 of the snap extrusion(s) 212.
  • This snap connection causes the plug 210 and the socket 220 to couple to one another, while the connection remains reversible.
  • an operator can disconnect the plug 210 and the socket 220, by moving them apart from one another which causes the snap lever(s) 224 to snap out of the cut portion(s) 214 of the snap extrusion(s) 212.
  • the spike 216 of the plug 210 traverses towards the septum 226 of the socket 220, but the spike 216 does not pierce the septum 226.
  • FIG. 17 shows a second stage of the exemplary two-stage snap connection, in accordance with some embodiments.
  • the snap extrusion(s) 212 of the plug 210 are traversed further into the corresponding channel(s) 221 of the socket 220, i.e., past the snap lever(s) 224 being snapped onto the cut portion(s) 214 of the snap extrusion(s) 212 (as the plug 210 is traversed further into the socket 220, the snap lever(s) 224 move out of the cut portion(s) 214 of the snap extrusion(s) 212).
  • the spike 216 penetrates the septum 226. Penetration of the septum 226 establishes a fluidic pathway through the plug 210 and socket 220.
  • the snap lever(s) 224 lock onto flange(s) 215 of the snap extrusion(s) 212.
  • this locking connection causes the plug 210 and the socket 220 to irreversibly couple to one another. For example, once the snap lever(s) 224 have locked onto the flange(s) 215 of the snap extrusion(s) 212, it would be difficult to disconnect the plug 210 and the socket 220 from one another.
  • Penetration of the septum 226 can allow fluid, e.g., a reagent, to flow through the fluidic pathway 223 of the socket 220 and the fluidic pathway 219 of the spike 216 (e.g., from the socket 220 to the plug 201, or vice versa).
  • the portion 228 may be connected to a cartridge, and the fluid can flow from or to the cartridge via the fluidic pathways 219 and 223.
  • Penetration of the septum 226 during the connection process establishes a fluidic pathway through the plug 210 and socket 220, while preventing, or minimizing, contamination, for example, for transporting fluid to/from a cartridge.
  • the fluid may flow through the fluidic pathways with aid of gravity and/or a pump.
  • the first stage of the connection is reversible, such that the plug 210 can be disconnected from the socket 220, automatically, semi-automatically, or manually, after the first stage of the connection has been completed. This can be advantageous, for example, if an incorrect container and/or an incorrect cartridge has been loaded, and the connection process needs to be aborted.
  • the second stage of the connection is irreversible, such that the plug 210 cannot be disconnected from the socket 220 after the second stage of the connection has been completed (e.g., the snap lever(s) 224 are locked onto flange(s) 215 of the snap extrusion(s) 212).
  • the first stage can be a pre-connection for fluid staging, and can be (i) performed manually (e.g., by an operator), (ii) semi-automated or (iii) fully automated.
  • the second stage can be (i) performed manually (e.g., by an operator), (ii) semi -automated or (iii) fully automated.
  • the second stage may be performed by a controller (e.g., using a controller of a bioreactor to implement the second stage when reagent is needed for sample processing).
  • each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Quick-Acting Or Multi-Walled Pipe Joints (AREA)

Abstract

L'invention concerne des raccords qui empêchent, ou minimisent, la contamination dans des voies fluidiques pendant et après des processus d'accouplement et/ou de désaccouplement.
PCT/US2024/017920 2023-03-01 2024-02-29 Raccords pour la prévention ou la réduction de la contamination dans des environnements de traitement WO2024182637A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363487765P 2023-03-01 2023-03-01
US63/487,765 2023-03-01

Publications (1)

Publication Number Publication Date
WO2024182637A2 true WO2024182637A2 (fr) 2024-09-06

Family

ID=92590388

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/017920 WO2024182637A2 (fr) 2023-03-01 2024-02-29 Raccords pour la prévention ou la réduction de la contamination dans des environnements de traitement

Country Status (1)

Country Link
WO (1) WO2024182637A2 (fr)

Similar Documents

Publication Publication Date Title
JP6325510B2 (ja) 雄型バヨネットコネクター
US20030028156A1 (en) Fluid connector devices and methods of use
US20020185186A1 (en) Fluid transfer devices and methods of use
EP2811964B1 (fr) Dispositif de transvasement équipé d'un filtre pour fluide
EP2658502B1 (fr) Distribution à plusieurs flacons
CA2216924C (fr) Ensemble connecteur
US6655655B1 (en) Connector assemblies, fluid systems, and methods for making a connection
CN104272109B (zh) 样品引入系统
US20040162540A1 (en) Transfer device
CN113368345A (zh) 流体输送装置的改进型组件
US20110204622A1 (en) Male bayonet connector
US11904129B2 (en) Coupling device and method for using the same
JP4838938B2 (ja) モジュール式固相抽出プレートアセンブリ
CA2574322C (fr) Cartouche reversible de filtre a vide
WO2024182637A2 (fr) Raccords pour la prévention ou la réduction de la contamination dans des environnements de traitement
US11123738B2 (en) High pressure seal connector
CN214209158U (zh) 血管通路装置接合器和抽血套件
CN104614538A (zh) 多用一次性输血交叉配血试验组合器
US20210291162A1 (en) Storage Vial
CN210472677U (zh) 一种医疗废弃物收集设备
CN204422550U (zh) 多用一次性输血交叉配血试验组合器
CN219110627U (zh) 适配器、医疗设备以及中央供液系统
CN104380119A (zh) 用于生物分析仪器的流体连接设备、合适的流体部件及配有该流体部件的生物分析设备
JP2024530733A (ja) 遠心分離された材料の清浄な移送のための装置および方法