A connector

Abstract

The invention relates to a connector, a kit of parts and assembly comprising a connector, and a method of selectively forming two or more connections. The connector includes a housing extending between a distal end and a proximal end. The connector also includes a first valve element and a second valve element at one end of the housing. At least one fluid conduit provided at least partially within the housing, a first end of the at least one fluid conduit being fluidly connected to, or fluidly connectable to, a component, and a second end of the at least one fluid conduit operably engageable with at least one of the first valve element and the second valve element to selectively provide a fluid flow path through the at least one conduit and the respective valve element. The connector further includes least one activation mechanism operable to selectively cause relative movement between the at least one fluid conduit and at least one of the first valve element and the second valve element to enable operable engagement therebetween.

Description

A CONNECTORTECHNICAL FIELD

[0001] The invention relates to a connector. The invention also relates to a kit of parts and a method of providing two fluid pathways in a connector. Specifically, the invention relates to a fluid connector. More particularly, the invention relates to a sterile, or aseptic, connector providing two sterile, or aseptic, fluid pathways. The connector as discussed herein may be particularly suited to bioprocessing.BACKGROUND

[0002] In many processes, material is transferred between various components, such as containers, bags, consumables, vessels and modules. Often, processes require material to be transferred in a manner that prevents the introduction of contaminants, such as macroscopic particles, inorganic compounds, organic compounds or pathogens. These processes may include, without limitation, bioprocesses, chemical processes, pharmaceutical production processes, or food production processes. Materials may be transferred for various reasons during these processes, such as for treatment and preparation of materials, the combination of the materials for manufacturing processes, the removal of materials for testing or analysis, or for the removal of a final product. Various techniques exist to transfer material between components. These techniques can be labour intensive, costly, unsuited to automation and provide a risk of introducing contaminants during the transfer of material. In one example, material may be transferred between components manually, such as by decanting, or using instruments, such as pipettes. This is labour intensive and provides a high risk of contamination as it is a manual task where operators can make errors and expose the material to contaminants during transfer, and the material may be exposed to the environment during the transfer. Such processes are also difficult to automate, such as by using robotics, and so are not well suited for larger scale manufacture. In another example, a user may utilise tube welding to connect and disconnect tubes connected to respective components in a sterile manner. The manual process of tube welding must be done by highly skilled operators and is labour intensive. This process also relies upon the suitability for a container to be connected by tubing, which may not be the case in certain scenarios.

[0003] Bioprocessing can require various unit operations to be carried out on biological materials or substances. These unit operations depend upon the type of material or substanceand the target output of the process. Bio processing, in some non-limiting examples, may include biological processing, such as cell processing. Some examples of bioprocessing methods include cell and / or gene therapy manufacture, cell culture, processing of cellular materials or cellular products, processing of cells or microorganisms for water treatment, biofuel production, small molecule production, screening and process development, tissue engineering, production of cultured meat, processing of blood products, amongst others.

[0004] In examples, there may be a need for an apparatus, assemblies or systems for use in bioprocessing. Some non-limiting examples of such apparatus, assemblies or systems include an algae bioreactor for producing a biofuel therein, an apparatus for carrying out one or more operations in cell and / or gene therapy manufacture, an apparatus for producing small molecules from E.coli, an apparatus for deriving primary cells from solid biopsies and single organoid culture, an apparatus for separating blood products from whole blood, an apparatus for carrying out one or more operations in the growth of tissue grafts, and an apparatus for use in screening and process development.

[0005] In one particular non-limiting example, there may be a need for an apparatus for use in performing one or more unit operations in cell and / or gene therapy manufacture. In such examples, cell and gene therapy manufacturing processes are often complex and include manual or semi-automated steps across several devices and hence require multiple material transfers. Hence, a connection, particularly a sterile, or aseptic, connection, is desired between the devices.

[0006] The unit operations in cell and / or gene therapy manufacture may include, for example, cell collection, cell isolation, selection, cell expansion, cell washing, volume reduction, cell storage or transportation. The unit operations can vary immensely based on the manufacturing model (i.e. autologous versus allogenic), cell type, intended purpose, among other factors. In addition, cells are “living” entities sensitive to even the simplest manipulations (such as differences in a cell transferring procedure). The skilled person hence recognises that the provision of a reliable, universal, sterile and automatable connection is highly desired.

[0007] In some known connectors, devices are connected through genderless connectors, male-female connectors, threaded connectors or the like. However, whilst such connectors enable a sterile, or aseptic, connection, they cannot be disconnected and / or reconnected in a sterile, or aseptic, manner. This is of particular concern where multiple connections and disconnections are required during a manufacturing process.

[0008] Whilst connectors have been developed to enable sterile, or aseptic, connection and disconnection, such as those discussed in WO2021 / 123760 A1 , there remains the need to enable sterile, or aseptic, connection and disconnection between multiple components. In particular, there is a need to provide several sterile, or aseptic, fluid connections using a single connector.

[0009] Thus, the invention aims to obviate or mitigate at least one of the aforementioned problems. Particularly, the invention aims to obviate or mitigate some of the disadvantages associated with known connectors, particularly sterile, or aseptic, connectors.SUMMARY OF INVENTION

[0010] In one aspect, there is provided a connector for selectively providing at least two fluid pathways therethrough. The connector comprises: a housing extending between a distal end and a proximal end; a first valve element and a second valve element at one end of the housing; at least one fluid conduit provided at least partially within the housing, a first end of the at least one fluid conduit being fluidly connected to, or fluidly connectable to, a component, and a second end of the at least one fluid conduit operably engageable with at least one of the first valve element and the second valve element to selectively provide a fluid flow path through the at least one conduit and the respective valve element; and at least one activation mechanism operable to selectively cause relative movement between the at least one fluid conduit and at least one of the first valve element and the second valve element to enable operable engagement therebetween.

[0011] In this way, a connector is provided that enables multiple, separate, fluid pathways. The fluid pathways may be selectively connected and / or disconnected as desired by the user. This allows for multiple transfers of fluid through the same connector through different fluid pathways.

[0012] In some examples, each of the first valve element and the second valve element may comprise a pierceable seal. That is, the first valve element may be a first pierceable seal and the second valve element may be a second pierceable seal. Alternatively, the first valve element and the second valve element are formed as a single, unitary, pierceable seal.

[0013] In some examples, the proximal end may comprise the first valve element and the second valve element. In some examples, the distal end of the housing may comprise a third valve element.

[0014] In this way, the connector is closed, or sealed, at each end until the activation mechanism is actuated to engage the at least one fluid conduit with the first valve element or the second valve element.

[0015] In some examples, the third valve element may comprise a pierceable seal.

[0016] In some examples, the or each pierceable seal comprises a septum seal, such as a selfsealing or self-healing septum seal.

[0017] In some examples, the at least one fluid conduit may comprise a piercing member. The piercing member may face the pierceable seal of the first valve element and / or the second valve element. The piercing member may face the pierceable seal of the first valve element. The piercing member may face the pierceable seal of the second valve element. The piercing member may face the pierceable seal of the first valve element and the second valve element.

[0018] In some examples, the at least one activation mechanism may be operable to cause relative movement between the piercing member and the pierceable seal of the first valve element and / or the second valve element to enable the piercing member to pierce the pierceable seal and form the fluid flow path through the at least one fluid conduit and the pierceable seal. In some examples, the at least one activation mechanism may be operable to cause relative movement between the piercing member and the pierceable seal of the first valve element. In some examples, the at least one activation mechanism may be operable to cause relative movement between the piercing member and the pierceable seal of the second valve element. In some examples, the at least one activation mechanism may be operable to cause relative movement between the piercing member and the pierceable seal of the first valve element and the second valve element.

[0019] In some examples, the at least one fluid conduit may be a hollow needle. In some examples, the hollow needle may be a double-ended (e.g., a piercing end at each end of the) hollow needle.

[0020] In this way, the septum seal can be pierced two or more times in the same position by a piercing member or hollow needle to permit multiple connections through the same fluid conduit, whilst maintaining a sterile, sealed environment within the connector.

[0021] In some examples, the at least one activation mechanism may be operable to cause relative movement between the first end of the double-ended hollow needle and the proximal end of the housing to enable a first end of the double-ended hollow needle to pierce the pierceable seal of the first valve element and / or the second valve element. The at least one activation mechanism may be operable to cause relative movement between a second end of the double-ended hollow needle and the distal end of the housing to enable the second end of the double-ended hollow needle to pierce the pierceable seal of the third valve element.

[0022] In some examples, the connector may further comprise a selection mechanism operably coupled to the at least one fluid conduit and / or the first and second valve elements, and operable to move the fluid conduit and / or the first and second valve elements between: a first configuration in which the at least one fluid conduit is coaxially aligned with the first valve element so as to permit the operable engagement between the at least one fluid conduit and the first valve element, and a second configuration in which the at least one fluid conduit is coaxially aligned with the second valve element so as to permit the operable engagement between the at least one fluid conduit and the second valve element. In some examples, the selection mechanism may be operably coupled to the at least one fluid conduit. In some examples, the selection mechanism may be operably coupled to the first and second valve elements. In some examples, the selection mechanism may be operably coupled to the at least one fluid conduit and the first and second valve elements. In some examples, the at least one activation mechanism comprises a selection mechanism as contemplated above and / or herein.

[0023] In this way, the selection mechanism allows the connector to selectively permit the formation of a fluid pathway through the connector. For example, the fluid pathway may be selectively formed through the connector between a first component connected to one end of the connector and each of a second component and a third component connected to the other end of the connector. Alternatively, the selection mechanism allows the connector to selectively permit the formation of a fluid pathway between a first component connected to one end of the connector to each of a first port and a second port of an interface of a second component connected to the other end of the connector. The selection mechanism allows for selectively aligning the fluid conduit with the first valve element or the second valve element, and the activation mechanism can subsequently be actuated to create a fluid flow path through the fluid conduit and the selected valve element.

[0024] In some examples, operation of the selection mechanism may be automated. In some examples, the selection mechanism may be operable by a selection system of an automated system.

[0025] In some examples, the selection mechanism may be operated by a robot or by robotics. For example, the selection mechanism may be operable by a robotic arm. In some examples, the robotic arm terminates in an engaging portion configured and arranged to cooperate (e.g., engage) with the selection mechanism to operate the same.

[0026] In this way, the connector can be operated to select the fluid pathway therethrough in an automated manner. This allows the connector to be used to transfer fluids in an automated system, and operation of the connector can be controlled by a computer.

[0027] In some examples, the connector may comprise: a first fluid conduit, wherein a first end of the first fluid conduit is fluidly connected to, or fluidly connectable to, a component, and a second end of the first fluid conduit operably engageable with the first valve element; a first activation mechanism operable to cause relative movement between the first fluid conduit and the first valve element to enable the first fluid conduit to operably engage the first valve element, thereby providing a first fluid flow path through the first fluid conduit and the first valve element; a second fluid conduit, wherein a first end of the second fluid conduit is fluidly connected to, or fluidly connectable to, a component, and a second end of the second fluid conduit operably engageable with the second valve element; and a second activation mechanism operable to cause relative movement between the second fluid conduit and the second valve element to enable the second fluid conduit to operably engage the second valve element thereby providing a second fluid flow path through the second fluid conduit and the second valve element. In some examples, the first activation mechanism and the second activation mechanism may be independently operable.

[0028] The first fluid flow path may form a first fluid pathway through the connector between two components. The second fluid flow path may form a second fluid pathway through the connector between two components (which may be the same component, or different components^ fluidly connected via the first fluid pathway).

[0029] In this way, a connector is provided that enables multiple, separate, fluid pathways. The fluid pathways may be manipulated independently to enable connection and / or disconnection as desired by the user.

[0030] In some examples, the first valve element and the second valve element are the same valve element.

[0031] In some examples, the first valve element and the second valve element are distinct valve elements.

[0032] In some examples, operation of the at least one activation mechanism may be automated. In some examples, the at least one activation mechanism may be operable by an activation system of an automated system.

[0033] In some examples, the at least one activation mechanism may be operable by a robot or by robotics. For example, the at least one activation mechanism may be operable by a robotic arm. In some examples, the robotic arm terminates in an engaging portion configured and arranged to cooperate (e.g., engage) with the activation mechanism to operate the same.

[0034] In this way, the connector can be operated to establish fluid pathways therethrough in an automated manner. This allows the connector to be used to transfer fluids in an automated system, and operation of the connector can be controlled by a computer.

[0035] In some examples, the connector is a connector for introducing or extracting fluid to, or from, at least one component. In some examples, the connector is a connector for fluidly connecting at least a first component and a second component. Any number of components may be connected as described herein. In some examples, the fluid may comprise a biological material.

[0036] In some examples, the connector is an aseptic connector for selectively forming two or more aseptic connections. The aseptic connector may be arranged to aseptically fluidly connect two or more volumes of fluid. The aseptic connector may be arranged to provide two or more aseptic fluid pathways.

[0037] In some examples, the connector may be for use in a bioprocessing method. In some examples, the connector may be for use in cell and / or gene therapy manufacture.

[0038] In another aspect, there is provided a kit of parts. The kit of parts comprises: a connector as described herein; a first component connectable to the distal end of the housing; and a second component connectable to the proximal end of the housing.

[0039] In another aspect, there is provided an apparatus. The apparatus comprises: a connector as described herein; a first component connected to the distal end of the housing; and a second component connected to the proximal end of the housing.

[0040] In another aspect, there is provided a system. The system comprises: a connector as described herein, or the apparatus as described herein; and an activation system configured to operably engage with the at least one activation mechanism to cause relative movement between the at least one fluid conduit and the first valve element and / or the second valve element.

[0041] In this way, the activation system allows for automated actuation of the connector to selectively enable connection and / or disconnection of two fluid pathways through the connector as desired by the user.

[0042] In other examples, the connector, kit of parts, apparatus, or system may have features described herein with regard to other aspects and examples of the connectors, kit of parts, apparatus, or systems.

[0043] In another aspect, there is provided a method of transferring fluid through a connector. The method comprises: establishing a first fluid pathway between two ports of the connector to enable fluid communication through the connector; transferring a first fluid through the connector byway of the first fluid pathway; terminating the first fluid pathway to prevent fluid communication therethrough; establishing a second fluid pathway between two ports of the connector, the second fluid pathway being different from the first fluid pathway, to enable fluid communication through the connector; transferring a second fluid through the connector by way of the second fluid pathway.

[0044] In some examples, the step of establishing a first fluid pathway and / or the step of establishing a second fluid pathway may comprise selectively configuring the connector to place the respective two ports in fluid communication.

[0045] In some examples, one or both of the two ports of the first fluid pathway and one or both of the two ports of the second fluid pathway may be the same ports. In other words, one of the two ports of the first fluid pathway and a corresponding one of the two ports of the second fluid pathway may be the same port. Additionally or alternatively, the other of the two ports of the first fluid pathway and the corresponding other one of the two ports of the second fluid pathway may be the same port.

[0046] In some examples, the two ports of the first fluid pathway and the two ports of the second fluid pathway may be distinct.

[0047] In some examples, the first fluid and the second fluid may be the same fluid.

[0048] In some examples, the first fluid and the second fluid may be distinct fluids.

[0049] In some examples, the method may further comprise terminating the second fluid pathway to prevent fluid communication therethrough.

[0050] In some examples, the first fluid pathway and the second fluid pathway may be fluidly isolated from one another.

[0051] In some examples, establishing the first fluid pathway between two ports of the connector may comprise establishing a sealed first fluid pathway between two ports of the connector. In some examples, establishing the second fluid pathway between two ports of theconnector may comprise establishing a sealed second fluid pathway between two ports of the connector.

[0052] In some examples, establishing the first fluid pathway between two ports of the connector may comprise establishing a sterile first fluid pathway between two ports of the connector. In some examples, establishing the second fluid pathway between two ports of the connector may comprise establishing a sterile second fluid pathway between two ports of the connector.

[0053] In some examples, the first fluid pathway and the second fluid pathway may be independently establishable.

[0054] In some examples, each of the two ports may be a valve element.

[0055] In some examples, the first fluid pathway and / or the second fluid pathway may be formed at least partly by a fluid conduit arranged to engage each valve element.

[0056] In some examples, each of the two ports may comprise a pierceable seal. In some examples, the fluid conduit may be a double-ended hollow needle. In some examples, the step of establishing a first fluid pathway and / or establishing a second fluid pathway may comprise engaging each end of the hollow needle with the pierceable seal.

[0057] In some examples, the first fluid pathway may be a first aseptic fluid pathway. The second fluid pathway may be a second aseptic fluid pathway.

[0058] In some examples, the steps are ordered.

[0059] In some examples, two or more of the steps are concurrent. In one example, the steps of establishing a first fluid pathway and establishing a second fluid pathway may be concurrent. In another example, the steps of transferring a first fluid through the connector and transferring a second fluid through the connector may be concurrent. In another example the steps of terminating the first fluid pathway and terminating the second fluid pathway may be concurrent. In another example, the steps of terminating the first fluid pathway and establishing a second fluid pathway may be concurrent.

[0060] In some examples, the connector may be the connector as described herein.

[0061] In another aspect, there is provided a method of providing at least two fluid pathways to fluidly connect a component with two or more ports of one or more further components, the method comprising:providing a connector comprising: a housing extending between a distal end and a proximal end; a first valve element and a second valve element at one end of the housing; at least one fluid conduit provided at least partially within the housing, a first end of the at least one fluid conduit being fluidly connected to, or fluidly connectable to, a component, and a second end of the at least one fluid conduit operably engageable with at least one of the first valve element and the second valve element to selectively provide a fluid flow path through the at least one conduit and the respective valve element; and at least one activation mechanism operable to selectively cause relative movement between the at least one fluid conduit and at least one of the first valve element and the second valve element to enable operable engagement therebetweenconnecting the first valve element to a first port of the two or more ports;activating the at least one activation mechanism to cause the at least one fluid conduit to operably engage the first valve element and provide a fluid flow path through the at least one fluid conduit and the first valve element, to permit the flow of fluid from the component through the first port;deactivating the at least one activation mechanism to cause the at least one fluid conduit to operably disengage the first valve element and block the fluid flow path;connecting the second valve element to a second port of the two or more ports; andactivating the at least one activation mechanism to cause the at least one fluid conduit to operably engage the second valve element and provide a fluid flow path through the at least one fluid conduit and the second valve element, to permit the flow of fluid from the component through the second port.

[0062] In another aspect, there is provided a method of sampling a fluid from a container comprising:fluidly connecting a transfer component to a first end of a connector;fluidly connecting a second end of the connector to a port of the container to provide a first fluid pathway through the connector and the port of the container;withdrawing a volume of the fluid from the container into the transfer component via the first fluid pathway of the connector;fluidly disconnecting the second end of the connector from the port of the container;transferring the transfer component to an analytics module;fluidly connecting the second end of the connector to a port of the analytics module to provide a second fluid pathway through the connector and the port of the analytics module, the second fluid pathway being different from the first fluid pathway; andintroducing the volume of fluid from the transfer component into the analytics module via the second fluid pathway of the connector.

[0063] In some examples, fluidly connecting the connector to the transfer component, the port of the container and / or the port of the analytics module may comprise piercing a pierceable seal of the connector with a piercing member of the connector.

[0064] In some examples, each of the first fluid pathway and second fluid pathway may be sterile fluid pathways.

[0065] In some examples, the connector may be the connector as described herein.

[0066] In another aspect, a connector includes a housing extending between a distal end and a proximal end; a first fluid conduit provided at least partially within the housing, a first end of the first fluid conduit being fluidly connected to, or fluidly connectable to, a component, and a second end of the first fluid conduit operably engageable with a first valve element at one of the distal end and the proximal end of the housing; a first activation mechanism operable to cause relative movement between the first fluid conduit and the first valve element to enable the first fluid conduit to operably engage the first valve element, thereby providing a first fluid flow path through the first fluid conduit and the first valve element; a second fluid conduit provided at least partially within the housing, a first end of the second fluid conduit being fluidly connected to, or fluidly connectable to, a component, and a second end of the second fluid conduit operably engageable with a second valve element at one of the distal end and the proximal end; and a second activation mechanism operable to cause relative movement between the second fluid conduit and the second valve element to enable the second fluid conduit to operably engage the second valve element thereby providing a second fluid flow path through the second fluid conduit and the second valve element, where the first activation mechanism and the second activation mechanism are independently operable.

[0067] The first fluid flow path may form a first fluid pathway through the connector between two components. The second fluid flow path may form a second fluid pathway through theconnector between two components (which may be the same component, or different components^ fluidly connected via the first fluid pathway).

[0068] In this way, a connector is provided that enables multiple, separate, fluid pathways. The fluid pathways may be manipulated independently to enable connection and / or disconnection as desired by the user.

[0069] In some examples, the connector may comprise a plurality of fluid conduits, valve elements and activation mechanisms so as to form a plurality of fluid pathways through the connector. The connector, or a part thereof, may be moveable. The connector, or a part thereof, may be moveable to enable selection of a fluid conduit (or fluid conduits) for activation. The connector, or a part thereof, may be rotatable. The connector, or a part thereof, may be rotatable to enable selection of a fluid conduit (or fluid conduits) for activation. For example, the housing, or a portion of the housing, may be moveable or rotatable.

[0070] In this way, the connector (or part thereof) is moveable or rotatable to align one of the plurality of activation mechanisms with an actuator of an activation system. This allows for selected actuation of each fluid pathway through the connector. For example, the housing, or a portion of the housing, may be moveable or rotatable to align one of the plurality of activation mechanisms with an actuator of an activation system.

[0071] In some examples, the first valve element and the second valve element are the same valve element. That is, the first valve element and the second valve element may form a single valve element or a unitary valve element. As such, each fluid conduit is operably engageable with the valve element. As such, the first fluid conduit may be operably engageable with the valve element, thereby providing a first fluid pathway through the connector (e.g. through the valve element), and the second fluid conduit may be operably engageable with the valve element, thereby providing a second fluid pathway through the connector (e.g. through the valve element).

[0072] In some examples, the first valve element and the second valve element are distinct valve elements. That is, the first valve element and the second valve element are formed as separate, and distinct, valve elements. As such, the first fluid conduit may be operably engageable with the first valve element, thereby providing a first fluid pathway through the connector (e.g. through the first valve element), and the second fluid conduit may be operably engageable with the second valve element, thereby providing a second fluid pathway through the connector (e.g. through the second valve element).

[0073] In some examples, each of the distal end and the proximal end of the housing comprise at least one valve element. That is, there may be provided at least one valve element, or one ormore valve elements, at the distal end of the housing, and there may be provided at least one valve element, or one or more valve elements, at the proximal end of the housing.

[0074] In this way, the connector is closed, or sealed, at each end until the first or second activation mechanism is actuated to provide the fluid flow path through the respective fluid conduit and valve element.

[0075] In some examples, the first valve element and the second valve element comprise a pierceable seal. That is, the first valve element may be a first pierceable seal and the second valve element may be a second pierceable seal. Alternatively, the first valve element and the second valve element are formed as a single, unitary, pierceable seal.

[0076] In some examples, the or each pierceable seal comprises a septum seal, such as a selfsealing or self-healing septum seal.

[0077] In this way, the septum seal can be pierced two or more times in the same position by a piercing member to permit multiple connections through the same fluid conduit, whilst maintaining a sterile, sealed environment within the connector.

[0078] In some examples, each of the second end of the first fluid conduit and the second end of the second fluid conduit comprise a piercing member.

[0079] In this way, the piercing member of the first fluid conduit faces the first pierceable seal and the piercing member of the second fluid conduit faces the second pierceable seal.Accordingly, the first activation mechanism is operable to cause piercing of the piercing member of the first fluid conduit through the first pierceable seal, and the second activation mechanism is operable to cause piercing of the piercing member of the second fluid conduit through the second pierceable seal. In this way, the respective piercing of the first pierceable seal and the second pierceable seal by the first fluid conduit and the second fluid conduit provides, respectively, provides a first communication through the first pierceable seal and a second communication through the second pierceable seal.

[0080] In some examples, each end of the first fluid conduit includes a piercing member. That is, the first end of the first fluid conduit comprises a piercing member and the second end of the first fluid conduit comprises a piercing member. In other words, the first end of the first fluid conduit is a first piercing end of the first fluid conduit, and the second end of the first fluid conduit is a second piercing end of the first fluid conduit.

[0081] In some examples, each piercing member of the first fluid conduit faces a pierceable seal at each end of the housing. That is, the first end of the first fluid conduit comprises a piercingmember facing a pierceable seal at one end of the housing, and the second end of the first fluid conduit comprises a piercing member facing a pierceable seal at the other end of the housing. In other words, the first piercing end of the first fluid conduit faces a pierceable seal at one end of the housing, and the second piercing end of the first fluid conduit faces a pierceable seal at the other end of the housing.

[0082] In this way, the connector is closed, or sealed, at each end. Actuation of the first activation mechanism causes relative movement between each piercing member and the pierceable seal that it faces to create a fluid flow path through the respective piercing member and pierceable seal and permit fluid communication therethrough. Furthermore, each piercing member can be independently actuated by a single or respective activation mechanism to pierce the respective pierceable seal at each end of the housing.

[0083] In some examples, the first piercing end of the first fluid conduit faces a pierceable seal at distal end of the housing, and the second piercing end of the first fluid conduit faces a pierceable seal at the proximal end of the housing.

[0084] In some examples, each end of the second fluid conduit includes a piercing member. That is, the first end of the second fluid conduit comprises a piercing member and the second end of the second fluid conduit comprises a piercing member. In other words, the first end of the second fluid conduit is a first piercing end of the second fluid conduit, and the second end of the second fluid conduit is a second piercing end of the second fluid conduit.

[0085] In some examples, each piercing member of the second fluid conduit faces a pierceable seal at each end of the housing. That is, the first end of the second fluid conduit comprises a piercing member facing a pierceable seal at one end of the housing, and the second end of the second fluid conduit comprises a piercing member facing a pierceable seal at the other end of the housing. In other words, the first piercing end of the second fluid conduit faces a pierceable seal at one end of the housing, and the second piercing end of the second fluid conduit faces a pierceable seal at the other end of the housing.

[0086] In this way, the connector is closed, or sealed, at each end. Actuation of the second activation mechanism causes relative movement between each piercing member and the pierceable seal that it faces to create a fluid flow path through the respective piercing member and pierceable seal and permit fluid communication therethrough. Furthermore, each piercing member can be independently actuated by a single or respective activation mechanism to pierce the respective pierceable seal at each end of the housing.

[0087] In some examples, the first piercing end of the second fluid conduit faces a pierceable seal at the distal end of the housing, and the second piercing end of the second fluid conduit faces a pierceable seal at the proximal end of the housing.

[0088] In some examples, each end of the first fluid conduit includes a piercing member, and each end of the second fluid conduit includes a piercing member. In such cases, the first piercing end of the first fluid conduit and the first piercing end of the second fluid conduit may face the same pierceable seal at one end of the housing, such as at the distal end of the housing. In other examples in such cases, the first piercing end of the first fluid conduit and the first piercing end of the second fluid conduit may face separate, or different, pierceable seals at one end of the housing, such as at the distal end of the housing.

[0089] In this way, the connector is closed, or sealed, at each end. Actuation of the respective activation mechanism causes relative movement between each piercing member and the pierceable seal that it faces to create a fluid flow path through the respective piercing member and pierceable seal and permit fluid communication therethrough. Furthermore, each piercing member can be independently actuated by a single or respective activation mechanism to pierce the respective pierceable seal at each end of the housing.

[0090] In some examples, the proximal end of the housing includes the first pierceable seal and the second pierceable seal. The second end of the first fluid conduit may face the first pierceable seal. The second end of the second fluid conduit may face the second pierceable seal.

[0091] In some examples, the first activation mechanism is operable to cause relative movement between the first fluid conduit and the first pierceable seal to enable the piercing member of the first fluid conduit to pierce the first pierceable seal and form the first fluid flow path through the first fluid conduit (e.g. through the first piercing member) and the first pierceable seal.

[0092] In some examples, the second activation mechanism is operable to cause relative movement between the second fluid conduit and the second pierceable seal to enable the piercing member of the second fluid conduit to pierce the second pierceable seal and form the second fluid flow path through the second fluid conduit (e.g. through the second piercing member) and the second pierceable seal.

[0093] In this way, the first and second activation mechanisms can be independently actuated to form first and second fluid flow paths through each of the piercing members and their respective pierceable seals. This provides for two fluid pathways through the connector. Eachfluid pathway is manipulated independently by the respective activation mechanism to enable connection and / or disconnection as desired by the user.

[0094] In some examples, one end of the housing comprises a third pierceable seal. In some examples, the distal end of the housing comprises a third pierceable seal.

[0095] In some examples, each of the first end of the first fluid conduit and the first end of the second fluid conduit comprises a piercing member that faces the third pierceable seal. That is, each of the first fluid conduit and the second fluid conduit comprises a piercing member that faces the third pierceable seal. In other words, the first piercing end of the first fluid conduit and the first piercing end of the second fluid conduit faces the third pierceable seal.

[0096] In this way, the connector is closed, or sealed, at each end. Actuation of the respective activation mechanism causes relative movement between the first piercing end of each of the first and second fluid conduits and the third pierceable seal to create a fluid flow path through the respective piercing member and the third pierceable seal and permit fluid communication therethrough. The third pierceable seal can be pierced by the piercing members of each of the first and second fluid conduits to provide two fluid flow paths through the third pierceable seal.

[0097] In some examples, the connector may also include a third fluid conduit mounted at least partially between the distal end and the proximal end of the housing, a first end of the third fluid conduit fluidly connected to the first end of the first fluid conduit, and a second end of the third fluid conduit facing the third pierceable seal, the second end of the third fluid conduit includes a piercing member; a third activation mechanism operable to cause relative movement between the third fluid conduit and the third pierceable seal to enable the piercing member of the third fluid conduit to pierce the third pierceable seal and form a third fluid flow path through the third fluid conduit (e.g. the piercing member of the third fluid conduit) and the third pierceable seal; where the first activation mechanism, the second activation mechanism, and the third activation mechanism are each independently operable.

[0098] That is, the connector may include at least three fluid conduits. The first fluid conduit may be fluidly connected to the third fluid conduit to provide fluid communication between the first fluid conduit and the third fluid conduit. The first fluid conduit and the third fluid conduit may each be moveable, by their respective activation mechanisms, to cause relative movement and hence piercing through their respective pierceable seals.

[0099] In this way, the first, second and third activation mechanisms can be independently actuated to form first, second and third fluid flow paths through each of the piercing members and their respective pierceable seals. The third fluid conduit and the first fluid conduit are fluidlyconnected to provide the first fluid pathway through the connector. The third fluid conduit and first fluid conduit are independently actuatable to allow for controlled connection to, and disconnection from, components connected at each end of the housing, as desired by the user.

[0100] In some examples, the first end of the third fluid conduit is fluidly connected to the first end of the first fluid conduit by a tube. In some examples, the tube may be a flexible tube. In other examples, the tube may be an extendible tube. For example, at least a portion of the tube may comprise a bellows (or a bellows arrangement) to allow the tube to be extended and compressed.

[0101] In this way, the tube provides a fluid-tight passage between the third fluid conduit and the first fluid conduit to provide the first fluid pathway through the connector. The flexible tube or extendible tube provides a flexible connection between the first and third fluid conduits to permit independent actuation of the first fluid conduit and the third fluid conduit by the respective activation mechanism. This allows for the formation of the first fluid flow path and the third fluid flow path to be independently controlled to enable connection and / or disconnection as desired by the user.

[0102] In some examples, one end of the housing comprises a fourth pierceable seal. In some examples, the distal end of the housing comprises a fourth pierceable seal.

[0103] In some examples, the first end of the first fluid conduit faces the third pierceable seal, and the first end of the second fluid conduit faces the fourth pierceable seal. That is, the first fluid conduit comprises a piercing member that faces the third pierceable seal, and the second fluid conduit comprises a piercing member that faces the fourth pierceable seal. In other words, the first piercing end of the first fluid conduit faces the third pierceable seal, and the first piercing end of the second fluid conduit faces the fourth pierceable seal.

[0104] In this way, the connector is closed, or sealed, at each end. Actuation of the respective activation mechanism causes relative movement between the first piercing end of each of the first and second fluid conduits to create a fluid flow path through the piercing member and the respective third or fourth pierceable seal and permit fluid communication therethrough.

[0105] In some examples, the connector may also include a fourth fluid conduit mounted at least partially between the distal end and the proximal end of the housing, a first end of the fourth fluid conduit fluidly connected to the first end of the second fluid conduit, and a second end of the fourth fluid conduit facing the fourth pierceable seal, the second end of the fourth fluid conduit includes a piercing member; a fourth activation mechanism operable to cause relative movement between the fourth fluid conduit and the fourth pierceable seal to enable the piercing member of the fourth fluid conduit to pierce the fourth pierceable seal and form a fourth fluidflow path through the fourth fluid conduit (e.g. the piercing member of the fourth fluid conduit) and the fourth pierceable seal; where the first activation mechanism, the second activation mechanism, the third activation mechanism, and the fourth activation mechanism are each independently operable.

[0106] That is, the connector may include at least four fluid conduits. The first fluid conduit may be fluidly connected to the third fluid conduit to provide fluid communication between the first fluid conduit and the third fluid conduit, and the second fluid conduit may be fluidly connected to the fourth fluid conduit to provide fluid communication between the second fluid conduit and the fourth fluid conduit. The first fluid conduit, the second fluid conduit, the third fluid conduit and the fourth fluid conduit may each be moveable, by their respective activation mechanisms, to cause relative movement and hence piercing through their respective pierceable seals.

[0107] In this way, the first, second, third and fourth activation mechanisms can be independently actuated to form first, second, third and fourth fluid flow paths through each of the piercing members and their respective pierceable seals. The third fluid conduit and the first fluid conduit are fluidly connected to provide the first fluid pathway (or first fluid communication) through the connector, and the fourth fluid conduit and the second fluid conduit are fluidly connected to provide the second fluid pathway (or second fluid communication) through the connector. Each fluid conduit is independently actuatable to allow for controlled connection to, and disconnection from, components connected at each end of the housing, as desired by the user.

[0108] In some examples, the first end of the fourth fluid conduit is fluidly connected to the first end of the second conduit by a tube. In some examples, the tube may be a flexible tube. In other examples, the tube may be an extendible tube. For example, at least a portion of the tube may comprise a bellows (or a bellows arrangement) to allow the tube to be extended and compressed.

[0109] In this way, the tube provides a fluid-tight passage between the fourth fluid conduit and the second fluid conduit to provide the second fluid pathway through the connector. The flexible tube or extendible tube provides a flexible connection between the second and fourth fluid conduits to permit independent actuation of the second fluid conduit and the fourth fluid conduit by the respective activation mechanism. This allows for the formation of the second fluid flow path and the fourth fluid flow path to be independently controlled to enable connection and / or disconnection as desired by the user.

[0110] In some examples, any activation mechanism described herein (e.g. the first activation mechanism, the second activation mechanism, the third activation mechanism and / or the fourthactivation mechanism) may include an axially moveable collar coupled to its respective fluid conduit (e.g. the first fluid conduit, the second fluid conduit, the third fluid conduit and / or the fourth fluid conduit).

[0111] In some examples, the collar includes one or more protrusions engageable by an actuator of an activation system. The activation system may be an external activation system, i.e. separate to the connector.

[0112] In this way, actuation of each fluid conduit can be automated by engagement of the actuator of the activation system with the protrusion(s) of the respective collar.

[0113] In some examples, operation of the first activation mechanism and the second activation mechanism may be automated. In some examples, the first activation mechanism and the second activation mechanism may be operable by an activation system of an automated system.

[0114] In some examples, the first activation mechanism and the second activation mechanism may be operable by a robot or by robotics. For example, the first activation mechanism and the second activation mechanism may each be operable by a robotic arm. In some examples, the robotic arm terminates in an engaging portion configured and arranged to cooperate (e.g., engage) with each activation mechanism to operate the same. The first activation mechanism and the second activation mechanism may each be operable by the same robotic arm or different robotic arms.

[0115] In this way, the connector can be operated to independently establish at least two fluid pathways therethrough in an automated manner. This allows the connector to be used to transfer fluids in an automated system, and operation of the connector can be controlled by a computer.

[0116] In some examples, the connector is a connector for introducing or extracting fluid to, or from, at least one component. In some examples, the connector is a connector for fluidly connecting at least a first component and a second component. Any number of components may be connected as described herein. In some examples, the fluid may comprise a biological material.

[0117] In some examples, the connector is a sterile connector. The sterile connector may be arranged to fluidly connect two or more volumes of fluid in a sterile manner. The sterile connector may be arranged to provide two or more sterile fluid pathways.

[0118] In some examples, the connector is an aseptic connector. The aseptic connector may be arranged to aseptically fluidly connect two or more volumes of fluid. The aseptic connector may be arranged to provide two or more aseptic fluid pathways.

[0119] In some examples, each of the valve elements, for example the first, second, third and / or fourth valve elements, are coupled to an aseptic seal system. The aseptic seal system may be configured to couple to a further aseptic seal system of a component. The aseptic seal system may comprise an aseptic membrane arranged to seal the valve element and a housing portion coupled to the aseptic membrane and configured to be engaged by an actuator to remove the aseptic membrane from the valve element.

[0120] In this way, the aseptic seal system maintains sterility of the valve element prior to use. This enables an aseptic face-to-face engagement between valve elements, such as pierceable seals, of respective components.

[0121] In some examples, the connector may be for use in a bioprocessing method. In some examples, the connector may be for use in cell and / or gene therapy manufacture.

[0122] In another aspect, there is provided a sterile package or a sterile container comprising the connector as described herein.

[0123] In another aspect, there is provided a kit of parts, includes a connector as described herein, a first component connectable to one end (e.g. the distal end) of the housing, and a second component connectable to the other end (e.g. the proximal end) of the housing.

[0124] The first component and / or the second component may be any component as described herein.

[0125] In some examples, the kit of parts may further comprise a third component connectable to an end (e.g. the proximal end) of the housing. In examples, the kit of parts may further comprise a fourth component connectable to an end (e.g. the distal end) of the housing.

[0126] In another aspect, there is provided an apparatus, comprising a connector as described herein, a first component connected to one end (e.g. the distal end) of the housing, and a second component connected to the other end (e.g. the proximal end) of the housing.

[0127] The first component and / or the second component may be any component as described herein.

[0128] In another aspect, there is provided a system, comprising a connector as described herein, or the apparatus as described herein; and an activation system configured to operably engage with the first activation mechanism to cause relative movement between the first fluidconduit and the first valve element, and further configured to operably engage with the second activation mechanism to cause relative movement between the second fluid conduit and the second valve element.

[0129] In this way, the activation system allows for automated actuation of the connector to independently to enable connection and / or disconnection of two fluid pathways through the connector as desired by the user.

[0130] In another aspect, there is provided a method of using the connector as described herein.

[0131] In some examples, the method comprises activating the first activation mechanism to cause relative movement between the first fluid conduit and the first valve element such that the first fluid conduit operably engages the first valve element to form a first fluid communication (e.g. a first fluid pathway) through the connector; and activating the second activation mechanism to cause relative movement between the second fluid conduit and the second valve element such that the second fluid conduit operably engages the second valve element to form a second fluid communication (e.g. a second fluid pathway) through the connector.

[0132] In another aspect, there is provided a method of forming two fluid communications or pathways in a connector, comprising activating a first activation mechanism to cause relative movement between a first fluid conduit and a first valve element such that the first fluid conduit operably engages the first valve element to form a first fluid pathway or first fluid communication through the connector; and activating a second activation mechanism to cause relative movement between a second fluid conduit and a second valve element such that the second fluid conduit operably engages the second valve element to form a second fluid pathway or second fluid communication through the connector.

[0133] In some examples, the method further comprises deactivating the first activation mechanism to cause relative movement between the first fluid conduit and the first valve element such that the first fluid conduit operably disengages the first valve element to block the first fluid pathway or prevent the first fluid communication.

[0134] In some examples, the method further comprises deactivating the second activation mechanism to cause relative movement between the second fluid conduit and the second valve element such that the second fluid conduit operably disengages the second valve element to block the second fluid pathway or prevent the second fluid communication.

[0135] In some examples of the method described herein, the connector is an aseptic connector, and the first fluid pathway or the first fluid communication is a first aseptic fluid pathway or a first aseptic fluid communication, and the second fluid pathway or second fluid communication is a second aseptic fluid pathway or a second aseptic fluid communication.

[0136] In some examples, the step of activating the first activation mechanism comprises piercing a first pierceable seal with a piercing member of the first fluid conduit, and the step of activating the second activation mechanism comprises piercing a second pierceable seal with a piercing member of the second fluid conduit.

[0137] In some examples, the first component and / or the second component comprise a volume of fluid. In some examples, the fluid comprises a biological material. In some examples, the fluid is for use in a bioprocessing method. In some examples, the fluid is for use in cell and / or gene therapy manufacture.

[0138] In some examples, the first component and / or the second component is one of: a receptacle, a container, a vacutainer, an interface, a cell processing module, a cell processing interface, a bioreactor or the like.

[0139] In some examples, the first component and / or the second component comprises an interface coupled to a container. In some examples, the first component and / or the second component comprises a container.

[0140] In some examples, in the kit of parts as described herein, or in the apparatus as described herein, the first component and / or the second component includes an interface coupled to a container. In some examples, in the kit of parts as described herein, or in the apparatus as described herein, the first component and / or the second component includes a container.

[0141] In another aspect of the invention, there is provided a connector. The connector comprises:a housing extending between a distal end and a proximal end;a fluid conduit provided at least partially within the housing, a first end of the fluid conduit being fluidly connected to, or fluidly connectable to, a component, and a second end of the fluid conduit operably engageable with a valve element at one of the distal end and the proximal end of the housing, wherein the valve element is moveable with respect to the fluid conduit;an activation mechanism operable to cause relative movement between the fluid conduit and the valve element to enable the fluid conduit to operably engage the valve element, thereby providing a fluid flow path through the fluid conduit and the valve element; anda selection mechanism operably coupled to at least one of the fluid conduit and the valve element, and operable to move at least one of the fluid conduit and the valve element to coaxially align the second end of the fluid conduit with the valve element so as to permit the operable engagement between the fluid conduit and the valve element.

[0142] In this way, the selection mechanism allows the connector to selectively permit, and prevent, the formation of a fluid pathway through the connector. For example, the fluid pathway may be selectively formed between a first component coupled to one end of the connector and a second component coupled to the other end of the connector. Specifically, the connector can be used to selectively permit the formation of a fluid pathway between the first component to the second component by moving the valve element into coaxial alignment with the fluid conduit, and to selectively prevent the formation of a fluid pathway between the first component from the second component by moving the valve element out of coaxial alignment with the fluid conduit. Furthermore, the activation mechanism allows the connector to selectively connect and disconnect the first and second components when the valve element is in coaxial alignment with the fluid conduit by creating a fluid flow path through the fluid conduit and the valve element to provide the fluid pathway through the connector between the components.

[0143] In another aspect of the invention, there is provided a connector. The connector comprises:a housing extending between a distal end and a proximal end, the distal end connected to, or connectable to, a component, and the proximal end comprising a first valve element and a second valve element;a fluid conduit provided at least partially within the housing, the first end of the fluid conduit being fluidly connected to, or fluidly connectable to, the component, and a second end of the fluid conduit operably engageable with the first valve element or the second valve element; andan activation mechanism operable to cause relative movement between the fluid conduit and the proximal end of the housing to enable the second end of fluid conduit to operably engagethe first valve element or the second valve element, thereby providing a fluid flow path through the fluid conduit and the first valve element or second valve element; anda selection mechanism operably coupled to at least one of the proximal end of the housing, the first valve element, the second valve element, or the fluid conduit, and operable to move at least one of the proximal end of the housing, the first valve element, the second valve element, or the fluid conduit between a first configuration in which the fluid conduit is coaxially aligned with the first valve element, and a second position in which the fluid conduit is coaxially aligned with the second valve element.

[0144] In this way, the selection mechanism allows the connector to selectively permit the formation of a fluid pathway through the connector. For example, the fluid pathway may be selectively formed through the connector between a first component connected to one end of the connector and each of a second component and a third component connected to the other end of the connector. Alternatively, the selection mechanism allows the connector to selectively permit the formation of a fluid pathway between a first component connected to one end of the connector to each of a first port and a second port of an interface of a second component connected to the other end of the connector. The selection mechanism allows for selectively aligning the fluid conduit with the first valve element or the second valve element, and the activation mechanism can subsequently be actuated to create a fluid flow path through the fluid conduit and the selected valve element.

[0145] In examples, the selection mechanism may be operable to move at least one of the fluid conduit and the valve element between a first configuration in which the fluid conduit is coaxially aligned with the valve element, and a second configuration in which the fluid conduit is coaxially displaced from the valve element.

[0146] In this way, the selection mechanism selectively brings the valve element into coaxial alignment with the valve element to permit actuation of the connector to create a fluid flow path through the fluid conduit and the valve element. When the valve element is not in coaxial alignment with the valve element, the fluid conduit and the valve element cannot cooperate to form a fluid flow path, and fluid is prevented from entering, or exiting, the connector through the valve element.

[0147] In examples, the valve element may be a first valve element. The connector may further comprise a second valve element at the same end of the housing as the first valve element. The selection mechanism may be operably coupled to the fluid conduit and / or the first and secondvalve elements. The selection mechanism may be operable to move the fluid conduit and / or the first and second valve elements between: a first configuration in which the fluid conduit is coaxially aligned with the first valve element, and a second configuration in which the fluid conduit is coaxially aligned with the second valve element.

[0148] In this way, the selection mechanism allows the connector to selectively permit the formation of a fluid pathway through the connector. For example, the fluid pathway may be selectively formed through the connector between a first component connected to one end of the connector and each of a second component and a third component connected to the other end of the connector. Alternatively, the selection mechanism allows the connector to selectively permit the formation of a fluid pathway between a first component connected to one end of the connector to each of a first port and a second port of an interface of a second component connected to the other end of the connector. The selection mechanism allows for selectively aligning the fluid conduit with the first valve element or the second valve element, and the activation mechanism can subsequently be actuated to create a fluid flow path through the fluid conduit and the selected valve element.

[0149] In examples, each of the distal end and the proximal end of the housing may comprise a valve element. That is, there may be provided at least one valve element, or one or more valve elements, at the distal end of the housing, and there may be provided at least one valve element, or one or more valve elements, at the proximal end of the housing.

[0150] In this way, the connector is closed, or sealed, at each end until the activation mechanism is actuated to create a fluid flow path through the fluid conduit and respective valve element.

[0151] In examples, the valve element may comprise a pierceable seal. The fluid conduit may be a hollow needle.

[0152] In examples, the pierceable seal may comprise a septum seal, such as a self-sealing or self-healing septum seal.

[0153] In this way, the septum seal can be pierced two or more times in the same position by a piercing member to permit multiple connections through the same fluid conduit, whilst maintaining a sterile, sealed environment within the connector.

[0154] In examples, the activation mechanism may be operable to cause relative movement between the hollow needle and the pierceable seal to enable the hollow needle to pierce the pierceable seal and form the fluid flow path through the hollow needle and the pierceable seal. Insome examples, the activation mechanism may enable axial translation of the hollow needle. In some examples, the axial translation of the hollow needle may enable the hollow needle to pierce the pierceable seal.

[0155] In examples, the hollow needle may be a double-ended hollow needle.

[0156] In examples, the activation mechanism may be operable to cause relative movement between the first end of the double-ended hollow needle and one of the proximal end or the distal end of the housing to enable the first end of the double-ended hollow needle to pierce the pierceable seal of the valve element at said proximal end or distal end. The activation mechanism may further be operable to cause relative movement between the second end of the double-ended hollow needle and the other of the proximal end or distal end of the housing to enable the second end of the double-ended hollow needle to pierce the pierceable seal of the valve element at said other of the proximal end or distal end.

[0157] In examples, the activation mechanism may comprise a first activation element operable to cause relative movement between the first end of the double-ended hollow needle and one of the proximal end or the distal end of the housing to enable the first end of the double-ended hollow needle to pierce the pierceable seal of the valve element at said proximal end or distal end. The activation mechanism may further comprise a second activation element operable to cause relative movement between the second end of the double-ended hollow needle and the other of the proximal end or distal end of the housing to enable the second end of the double-ended hollow needle to pierce the pierceable seal of the valve element at said other of the proximal end or distal end.

[0158] In examples, the selection mechanism may be a first selection mechanism. The connector may further comprise a second selection mechanism operably coupled to at least one of the fluid conduit and the valve element at the other of the proximal end or distal end. The second selection element may be operable to move at least one of the fluid conduit and the valve element to coaxially align the first end of the fluid conduit with the valve element so as to permit the operable engagement between the fluid conduit and the valve element.

[0159] In this way, the connector can be used to selectively permit the formation of a fluid pathway through the connector between either of a first or second valve element at one end of the connector and either of a third or fourth valve element at the other end of the connector. This allows for selectively connecting one of two components connected to one end of the connector to one of two components connected to the other end of the connector, or to one of two ports of an interface of a component connected to the other end of the connector housing.

[0160] In examples, the housing may comprise a static portion and a selection portion moveably coupled to the static portion at one of the proximal end or the distal end of the housing. The selection portion may comprise the valve element.

[0161] In this way, the selection portion of the housing is moveable to selectively coaxially align the valve element with the fluid conduit.

[0162] In examples, the selection mechanism may be operably coupled to the selection portion of the housing.

[0163] In some examples, the selection portion may be slidably coupled to the static portion. In examples, the static portion may comprise an end surface facing the selection portion, and the selection portion may be configured to slide against the end surface. In examples, the selection portion may have a surface that corresponds to the end surface of the static portion. In examples, the static portion may extend along a longitudinal axis of the housing. The selection portion may slide in a direction that is not parallel to the longitudinal axis. In some examples, the selection portion may slide in a direction that is substantially perpendicular to the longitudinal axis. In other examples, the selection portion may slide along an arc that intersects with the longitudinal axis.

[0164] In other examples, the selection portion may be rotatably coupled to the static portion. In yet other examples, the selection portion may be pivotably coupled to the static portion.

[0165] In examples, the selection mechanism may comprise one or more protrusions engageable by an external actuator.

[0166] In this way, movement of the selection portion to selectively align the fluid conduit with the valve element can be automated by engagement of an external actuator with the protrusion(s) of the selection mechanism.

[0167] In some examples, operation of the selection mechanism may be automated. In some examples, the selection mechanism may be operable by a selection system of an automated system.

[0168] In some examples, the selection mechanism may be operated by a robot or by robotics. For example, the selection mechanism may be operable by a robotic arm. In some examples, the robotic arm terminates in an engaging portion configured and arranged to cooperate (e.g., engage) with the selection mechanism to operate the same.

[0169] In this way, the connector can be operated to select the fluid pathway therethrough in an automated manner. This allows the connector to be used to transfer fluids in an automated system, and operation of the connector can be controlled by a computer.

[0170] In examples, the housing may further comprise a flexible wall extending between the moveable portion and the static portion. In some examples, the flexible wall may be sealed to the moveable portion at one end and sealed to the static portion at another end. In some examples, the flexible wall may be a bellows wall.

[0171] In this way, the flexible wall encloses an internal volume of the connector. The flexible wall seals the internal volume, providing an aseptic environment within the connector.

[0172] In examples, the selection portion may comprise an internal volume. A collapsible sleeve may extend between a first end and a second end. The first end may be connected to an outer surface of the fluid conduit. The second end may be connected to the selection portion. The second end may be connected to the internal volume of the selection portion. In some examples, the collapsible sleeve may be sealed to the outer surface of the fluid conduit at the first end. In some examples, the collapsible sleeve may be sealed to the selection portion at the second end. In some examples, the collapsible sleeve may be a bellows sleeve.

[0173] In this way, the collapsible sleeve encloses an end of the fluid conduit and the internal volume of the selection volume. This creates a sealed, sterile environment for the end of the fluid conduit, so as to at least substantially prevent the introduction of contaminants into the fluid conduit, or onto the end of the fluid conduit.

[0174] In examples, the activation mechanism may comprise an axially moveable collar coupled to the fluid conduit. The collar may be slidably mounted within the housing. In some examples, the collar may be slidably mounted within the static portion of the housing. In some examples, the collar may be fixed to an external surface of the fluid conduit.

[0175] In examples, the collar may comprise one or more protrusions engageable by an external actuator.

[0176] In this way, actuation of the fluid conduit can be automated by engagement of an external actuator with the protrusion(s) of the collar.

[0177] In some examples, operation of the activation mechanism may be automated. In some examples, the activation mechanism may be operable by an activation system of an automated system.

[0178] In some examples, the activation mechanism may be operable by a robot or by robotics. For example, the activation mechanism may be operable by a robotic arm. In some examples, the robotic arm terminates in an engaging portion configured and arranged to cooperate (e.g., engage) with the activation mechanism to operate the same.

[0179] In this way, the connector can be operated to establish fluid pathways therethrough in an automated manner. This allows the connector to be used to transfer fluids in an automated system, and operation of the connector can be controlled by a computer.

[0180] In examples, the activation mechanism may further comprise an axially moveable connection element at one of the proximal end or the distal end of the housing. The connection element may be slidably mounted within the housing. In some examples, the connection element may be slidably mounted within the static portion of the housing. In some examples, the connection element is coupled to, or configured to be coupled to, the component.

[0181] In examples, the connection element may be configured to engage the collar when the connection element is actuated to slide within the housing.

[0182] In examples, the connection element may comprise one or more protrusions engageable by an external actuator.

[0183] In this way, movement of the connection element and actuation of the connector to create a fluid pathway therethrough can be automated by engagement of an external actuator with the protrusion(s) of the connection element.

[0184] In examples, the connector is a sterile connector. The sterile connector may be arranged to fluidly connect two or more volumes of fluid in a sterile manner. The fluid pathway may be a sterile fluid pathway.

[0185] In examples, the connector may be an aseptic connector. The fluid pathway may be an aseptic fluid pathway.

[0186] In some examples, each of the valve elements, for example the first and / or second valve elements, are coupled to an aseptic seal system. The aseptic seal system may be configured to couple to a further aseptic seal system of a component. The aseptic seal system may comprise an aseptic membrane arranged to seal the valve element and a housing portion coupled to the aseptic membrane and configured to be engaged by an actuator to remove the aseptic membrane from the valve element.

[0187] In this way, the aseptic seal system maintains sterility of the valve element prior to use. This enables an aseptic face-to-face engagement between valve elements, such as pierceable seals, of respective components.

[0188] In examples, the connector may be a connector for introducing fluid into, or extracting fluid from, at least one component. In examples, the connector may be a connector for transferring material between a first component and one or both of a second component and a third component. In some examples, the connector may be for transferring a fluid between a first component and one or both of a second component and a third component. In some examples, the fluid may comprise a biological material.

[0189] In examples, the connector may be for use in a bioprocessing method. In some examples, the connector may be for use in cell and / or gene therapy manufacture.

[0190] In another aspect of the present invention, there is provided a sterile package or a sterile container comprising the connector as described herein.

[0191] In another aspect of the invention, there is provided a kit of parts. The kit of parts comprises: a connector as described herein; a first component connectable to one end (e.g. the distal end) of the housing; and a second component connectable to the other end (e.g. the proximal end) of the housing.

[0192] The first component and / or the second component may be any component as described herein.

[0193] In examples, the kit of parts may further comprise a third component connectable to an end (e.g. the proximal end) of the housing. In examples, the kit of parts may further comprise a fourth component connectable to an end (e.g. the distal end) of the housing.

[0194] In another aspect of the invention, there is provided an apparatus. The apparatus comprises a connector as described herein; a first component connected to one end (e.g. the distal end) of the housing; and a second component connected to the other end (e.g. the proximal end) of the housing.

[0195] In examples, the apparatus may further comprise a third component connected to an end (e.g. the proximal end) of the housing. In examples, the apparatus may further comprise a fourth component connected to an end (e.g. the distal end) of the housing.

[0196] The first component and / or the second component may be any component as described herein.

[0197] In examples, the first component and / or the second component may comprise a container. In examples, the first component and / or the second component may comprise an interface coupled to a container.

[0198] In examples, the first component and / or the second component may comprise a volume of fluid. In some examples, the fluid may comprise a biological material. In some examples, the fluid may be for use in a bioprocessing method. In some examples, the fluid may be for use in cell and / or gene therapy manufacture.

[0199] In examples, the first component and / or the second component may be one of: a receptacle, a container, a vacutainer, an interface, a cell processing module, a cell processing interface, a bioreactor or the like.

[0200] In another aspect of the invention, there is provided a system. The system comprises: a connector as described herein or an apparatus as described herein; an activation system configured to operably engage with the activation mechanism to cause relative movement between the fluid conduit and the valve element, and a selection system configured to operably engage with the selection mechanism to cause relative movement between the fluid conduit and the valve element.

[0201] In this way, the activation system and selection system allow for automated selection and actuation of the connector to selectively connect a first component to a second component and optionally a third component.

[0202] In another aspect of the invention, there is provided a method of using a connector as described herein.

[0203] In examples, the method may comprise activating the selection mechanism to cause relative movement between the valve element and the fluid conduit to coaxially align the valve element with the fluid conduit; and activating the activation mechanism to cause relative movement between the fluid conduit and the valve element such that the fluid conduit operably engages the valve element to form a fluid pathway through the connector.

[0204] In another aspect of the invention, there is provided a method of forming a fluid pathway in a connector. The method comprises the steps of:activating a selection mechanism to cause relative movement between a first valve element at a first end of the connector and a fluid conduit to coaxially align the first valve element with the fluid conduit; andactivating an activation mechanism to cause relative movement between the fluid conduit and the first valve element such that the fluid conduit operably engages the first valve element to form a first fluid pathway through the connector.

[0205] In examples, the method may further comprise the step of deactivating the activation mechanism to cause relative movement between the fluid conduit and the first valve element such that the fluid conduit operable disengages the first valve element to block the first fluid pathway.

[0206] In examples, the method may further comprise the step of activating the selection mechanism to cause relative movement between a second valve element at the first end of the connector and the fluid conduit to coaxially align the second valve element with the fluid conduit. The method may further comprise the step of activating the activation mechanism to cause relative movement between the fluid conduit and the second valve element such that the fluid conduit operably engages the second valve element to form a second fluid pathway through the connector.

[0207] In some examples, the method may further comprise the step of deactivating the activation mechanism to cause relative movement between the fluid conduit and the second valve element such that the fluid conduit operable disengages the second valve element to block the second fluid pathway.

[0208] In examples, the connector may be an aseptic connector, and the first fluid pathway may be a first aseptic fluid pathway, and the second fluid pathway may be a second aseptic fluid pathway.

[0209] In examples, the first valve element may be a first pierceable seal, the fluid conduit may be a needle, and the step of activating the activation mechanism comprises piercing the first pierceable seal with the needle. In examples, the second valve element may be a second pierceable seal, and the step of activating the activation mechanism comprises piercing the second pierceable seal with the needle.

[0210] Other technical features may be readily apparent to one skilled in the art from the following figures, descriptions, and claims.

[0211] As used herein, the term “bioprocessing” is used to describe the processing of any biological material. A “biological material” is any material or substance taken or derived from a human or animal body, a plant, or another organism, including microorganisms. Some nonlimiting examples of biological material include tissue, cells, biomolecules such as DNA, rNA orproteins, fluids such as whole blood, saliva or urine, and the like, and any materials derived therefrom. Bioprocessing, according to a non-limiting example, includes one or more operations in the manufacture of a bioproduct. A bioproduct may include, but is not limited to, a cellular product, a blood product, a biofuel, or any other product containing a biological material. Such operations include, but are not limited to, the analysis, preparation, processing, storage, modification, manipulation, culturing, mixing, dilution, harvesting or the like of any suitable material used in the manufacture of a bioproduct. The material may include a medium for cells, with or without cells therein, a growth factor, a virus, a bead-based reagent, a final product such as a final bioproduct, or the like. In a specific non-limiting example, the bioproduct may be a cellular product. The cellular product may be a CAR-T product.

[0212] As used herein, the terms “sterile”, “aseptic” and like terms are intended to relate to an arrangement or configuration of an apparatus, a system, an element, a connection or a process in which the introduction of outside contaminants such as microbes is prevented, or at least substantially prevented, so as to mitigate the risk of contaminating a substance contained within or introduced into, or via, the apparatus, system element or connection, or used in the process.

[0213] As used herein, the term “axial translation” or “axial movement" is used to describe movement parallel or substantially parallel to a longitudinal axis, such as a central longitudinal axis of the connector.

[0214] As used herein, the term “collapse” or “collapsible” is used to describe shortening in length or movement to shorten in length.

[0215] As used herein, the term “receptacle” or “container” are used to describe any vessel or container able to hold a material, such as a solid or a fluid. The terms “receptacle” or “container” as used herein includes both rigid and flexible receptacles, including bags, bellows, bioreactors, flexible containers, rigid containers, vacutainers or the like.

[0216] As used herein, the term “bellows” is used to describe a wall or other element having a series of alternately arranged inward folds and outward folds, such as z-folds, that allow the wall or other element to collapse like a bellows or concertina.

[0217] As used herein, “piercing member” is used to describe a member capable of piercing a material. The pierceable member as used herein includes a hollow member ending in a point, such as a needle or a part thereof. The piercing member as used herein may include an aperture or bore to enable a fluid communication (e.g. a fluid inlet and / or a fluid outlet).

[0218] As used herein, the term “double-ended hollow needle” is used to describe a hollow needle that is pointed, or sharp, at both ends.

[0219] As used herein, the term “material” is used to describe any material, including a solid, a fluid, a gas, a liquid, a solution, a paste, a gel or the like.

[0220] As used herein, the term “fluid” is used to describe gases and liquids, including solutions, but also granular solids including powders. The granular solids need not be in a solution, although may equally be in a solution such as in the form of a suspension.

[0221] As used herein, the term “pierceable seal” is used to describe a seal that can be pierced, for example by a needle.

[0222] As used herein, the term “to pierce” is used to describe the piercing of a material, such that the piercing member or needle at least partially protrudes through the material.

[0223] As used herein, the term “self-sealing” or “self-healing”, in reference to a seal, is used to describe a seal that, once the cause of the piercing is removed, such as a needle, the seal can reseal automatically itself, thus the seal is configured and made of material that enables the opening or rupture to close and reseal.

[0224] As used herein, the term “septum seal” is used to describe a seal that comprises a material that provides an aseptic seal, but the material can also be pierced, for example, by a needle. Such “septum seal” may be made of any suitable material, for example, a thermoplastic elastomer, a silicone or the like.

[0225] It is noted that the terms “embodiments”, “aspects” and “examples” are not intended to be limiting on various combination, and the person skilled in the art will recognize that the various “embodiments” and “examples” discussed herein apply to any and all “aspects”.BRIEF DESCRIPTION OF THE DRAWINGS

[0226] Example embodiments of the invention are now described, byway of example only, hereinafter with reference to the accompanying drawings, in which:FIG. 1 illustrates a front perspective view of a connector in accordance with one embodiment of the invention;FIG. 2 illustrates a rear perspective view of the connector of FIG. 1 ;FIG. 3A illustrates a partial cross-sectional view of the connector of FIG. 1 and FIG. 2 in an unactuated configuration;FIG. 3B illustrates a partial cross-sectional view of the connector of FIG. 1 and FIG. 2 in a first actuated configuration to provide a first fluid pathway;FIG. 3C illustrates a partial cross-sectional view of the connector of FIG. 1 and FIG. 2 in a second actuated configuration to provide a second fluid pathway;FIG. 4A illustrates a side view of an aseptic seal system of the connector of FIG. 1 and FIG.2;FIG. 4B illustrates a partial side view of the aseptic seal system of FIG. 4A;FIG. 4C illustrates a pierceable seal of the connector as described herein;FIG. 5 illustrates a method in accordance with one embodiment of the invention;FIG. 6 illustrates an front perspective view of a connector in accordance with another embodiment of the invention;FIG. 7A illustrates a partial cross-sectional view of the connector of FIG. 6;FIG. 7B illustrates a top and bottom view of the connector of FIG. 6;FIG. 8 illustrates a partial cross-sectional view of a connector in accordance with another embodiment of the invention;FIG. 9A illustrates a partial cross-sectional view of the connector of FIG. 8 in a first unactuated configuration;FIG. 9B illustrates a partial cross-sectional view of the connector of FIG. 8 in a first actuated configuration;FIG. 9C illustrates a partial cross-sectional view of the connector of FIG. 8 in a second unactuated configuration;FIG. 9D illustrates a partial cross-sectional view of the connector of FIG. 8 in a second actuated configuration; andFIG. 10 illustrates a method of forming two fluid pathways in a connector.DETAILED DESCRIPTION

[0227] The described example embodiment relates to a connector and a method of use. They primarily relate to connectors used for the transfer of material in a sterile or aseptic manner. In particular, the connectors may be used in bioprocessing, such as in cell and / or gene therapy, but are not limited thereto.

[0228] As used herein, the terms “connected”, “attached”, “coupled”, “mounted” are intended to include direct connections between two members without any other members interposed therebetween, as well as, indirect connections between members in which one or more other members are interposed therebetween. The terminology includes the words specifically mentioned above, derivatives thereof, and words of similar import.

[0229] Certain terminology is used in the following description for convenience only and is not limiting. The words “right”, “left”, “lower”, “upper”, “front”, “rear”, “upward”, “down”, “downward”, “above” and “below” designate directions in the drawings to which reference is made and are with respect to the described part when assembled and mounted (e.g. in situ). The words “inner”, “inwardly” and “outer”, “outwardly” refer to directions toward and away from, respectively, a designated centreline or a geometric centre of an element being described (e.g. central axis), the particular meaning being readily apparent from the context of the description. Further, the terms “proximal” (i.e. nearer to) and “distal” (i.e. away from) designate positions relative to a body or a point of attachment.

[0230] Further, unless otherwise specified, the use of ordinal adjectives, such as, “first”, “second”, “third” etc. merely indicate that different instances of like objects are being referred to and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking or in any other manner. Like reference numerals are used to depict like features throughout.

[0231] Through the description and claims of this specification, the terms “comprise”, “include”, “have” and “contain”, and variations thereof, are interpreted to mean “including but not limited to”, and they are not intended to (and do not) exclude other moieties, additives, parts, integers or steps. Throughout the description and claims of this specification, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality, as well as, singularity, unless the context requires otherwise.

[0232] Further embodiments and examples are provided below with reference to FIG. 1 to FIG.10.

[0233] As shown in FIG. 1 and FIG. 2, there is provided a connector 100 including a housing 102 that generally extends between a distal end 104 and a proximal end 106. The housing 102 is provided so that a first component (not shown) is connectable to the distal end 104 and a second component (not shown) is connectable to the proximal end 106. The first and second components may be coupled to the connector 100 in any known manner. For example, the connector 100 is provided with a threaded portion 108 at the distal end 104 for coupling with corresponding threads of a component, although other mechanisms of coupling are equally contemplated. The threaded portion 108 depicted includes anti-rotational threads at its uppermost, distal, end to prevent unintended decoupling of the component (not shown) from the threaded portion 108 during use.

[0234] Additionally, as shown in FIG. 1 , and described in more detail below in respect of FIG. 4A and FIG. 4B, the connector 100 includes two aseptic seal systems 200 provided at the proximal end 106.

[0235] Referring further to FIG. 1 and FIG. 2, the housing 102 of the connector 100 generally includes a front portion and a rear portion. The front portion and rear portion are connected by two side portions. The front portion, rear portion and two side portions are generally formed as walls. As best shown in FIG. 2, the connector 100 includes a first activation mechanism 110 accessible through a first window 112 on the rear portion of the housing 102. There is also provided a second activation mechanism 114 accessible through a second window 116 on the rear portion of the housing 102, a third activation mechanism 118 accessible through a third window 120 on the rear portion of the housing 102, and a fourth activation mechanism 122 accessible through a fourth window 124 on a rear portion of the housing 102.

[0236] In the depicted example, the first window 112 and the third window 120 are provided on a first section of the rear portion of the housing 102, whilst the second window 116 and the fourth window 124 are provided on a section of the rear portion of the housing 102. The first section and the second section of the rear portion of the housing 102 are generally angled with respect to one another, although in other examples they may be provided co-planar.

[0237] The first window 112, the second window 116, the third window 120 and the fourth window 124 serve to provide as access means for one or more actuators of an activation system (not shown) which is engageable with each of the first activation mechanism 110, the second activation mechanism 114, the third activation mechanism 118 and the fourth activation mechanism 122 to enable the fluid flow paths and hence fluid pathways (or fluid communications) to be formed, during use, as discussed in more detail below. Each of the firstwindow 112, the second window 116, the third window 120 and the fourth window 124 generally define a limit through which their respective activation mechanism may operate. More specifically, each of the windows limit the axial movement of their respective activation mechanisms as discussed in more detail below.

[0238] FIG. 3A shows a partial cross-sectional view and best depicts each of the first activation mechanism 110, the second activation mechanism 114, the third activation mechanism 118, and the fourth activation mechanism 122 prior to use. This may be regarded as an unactuated configuration. The first activation mechanism 110 is provided to enable a first fluid conduit 136 (see FIG. 3B), particularly a piercing member 144 thereof, to pierce through the first pierceable seal 128 to form a first fluid flow path therethrough. The second activation mechanism 114 is provided to enable a second fluid conduit 138 (see FIG. 3B), particularly a piercing member 144 thereof, to pierce through the second pierceable seal 130 to form a second fluid flow path therethrough. The third activation mechanism 118 is provided to enable a third fluid conduit 140, particularly a piercing member 144 thereof, to pierce through the third pierceable seal 132 to form a third fluid flow path therethrough. Finally, the fourth activation mechanism 122 is provided to enable a fourth fluid conduit 142, particularly a piercing member 144 thereof, to pierce through the fourth pierceable seal 134 to form a fourth fluid flow path therethrough.

[0239] Each of the first activation mechanism 110, the second activation mechanism 114, the third activation mechanism 118 and the fourth activation mechanism 122 includes a collar 126 that is coupled to the respective fluid conduit. Each collar 126 is axially translatable and hence enables translation of the respective fluid conduit, during use. Each collar 126 is provided with a protrusion 148 that is engageable by one or more actuators of an activation system (not shown) to enable axial translation of the collar 126 and hence the respective fluid conduit. Whilst the protrusion 148 is shown as being generally square, it is appreciated that the protrusion 148 may have any suitable shape. As best shown in FIG. 2, the protrusion 148 protrudes into, and optionally through, each of the first window 112, the second window 116, the third window 120 and the fourth window 124, and each protrusion 148 is accessible by the one or more actuators of the activation system (not shown). The protrusion 148 of each activation system extends into the respective window, such that the window delimits the axial translation of the respective collar 126. That is, the axial displacement of the protrusion 148, and hence the collar 126, is defined by each window.

[0240] FIG. 3B shows a partial cross-sectional view similar to that of FIG. 3A except in that the first activation mechanism 110 and the third activation mechanism 118 have been actuated toprovide a first fluid pathway formed through the first fluid conduit 136 and first pierceable seal 128 (i.e. through the first fluid flow path formed), through the first flexible tube 146a and through the third fluid conduit 140 and third pierceable seal 132 (i.e. through the third fluid flow path formed). This may be regarded as the first actuated configuration. In this way, the first fluid pathway is provided between a component connected to the distal end 104 of the connector 100, specifically adjacent the first fluid conduit 136, and another component connected to the proximal end 106 of the connector 100, specifically adjacent the third fluid conduit 140.

[0241] In this example, although not shown, each component at the distal end 104 and the proximal end 106 may be provided with a pierceable seal. In this way, the piercing member 144 of each of the first fluid conduit 136 and the third fluid conduit 140 pierces through its respective first pierceable seal 128 and third pierceable seal 132, and also the pierceable seal of its respective component.

[0242] As shown in FIG. 3A and FIG. 3B, the first activation mechanism 110 and the third activation mechanism 118 each include the protrusion 148 as part of their respective collar 126. An actuator of an activation system (not shown) engages with the protrusion 148 and axially translates the collar 126. In the case of the first activation mechanism 110, the actuator of the activation system (not shown) engages with the protrusion 148 and axially translates the collar 126 downwardly, that is, towards the distal end 104. In the case of the third activation mechanism 118, the actuator of the activation system (not shown) engages with the protrusion 148 and axially translates the collar 126 upwardly, that is, towards the proximal end 106. The actuator of the activation system (not shown) may axially translate the respective collar 126 simultaneously or sequentially. Following actuation of the first activation mechanism 110 and the third activation mechanism 118, the first fluid pathway is formed through the connector 100, namely between the connected components.

[0243] In the first actuated configuration, as shown in FIG. 3B, a first fluid transfer may be provided between a first component, e.g. at the distal end 104, and a second component, e.g. at the proximal end 106. The first fluid transfer may be effected by a pump, such as a peristaltic pump, or another suitable means for enabling the first fluid transfer. In specific examples, the first component and / or the second component comprises a flexible, such as a compressible, container, and hence the first component and / or the second component may act as a pump.

[0244] Once the first fluid transfer is complete, the first activation mechanism 110 and the third activation mechanism 118 are unactuated by operating the first activation mechanism 110 and the third activation mechanism 118 in the opposite manner to that discussed above. In this way,the connector 100 returns to the unactuated configuration, as shown in FIG. 3A, in which the first fluid pathway is no longer formed, or otherwise blocked or prevented, such that the first fluid transfer (and, generally, a fluid transfer) cannot be effected.

[0245] FIG. 3C shows a partial cross-sectional view similar to that of FIG. 3A except in that the second activation mechanism 114 and the fourth activation mechanism 122 have been actuated to provide a second fluid pathway formed through the second fluid conduit 138 and second pierceable seal 130 (i.e. through the second fluid flow path formed), through the second flexible tube 146b and through the fourth fluid conduit 142 and fourth pierceable seal 134 (i.e. through the fourth fluid flow path formed). This may be regarded as the second actuated configuration. In this way, a second fluid pathway is provided between a component connected to the distal end 104 of the connector 100, specifically adjacent the second fluid conduit 138, and another component connected to the proximal end 106 of the connector 100, specifically adjacent the fourth fluid conduit 142.

[0246] In this example, although not shown, each component at the distal end 104 and the proximal end 106 may be provided with a pierceable seal. In this way, the piercing member 144 of each of the second fluid conduit 138 and the fourth fluid conduit 142 pierces through its respective second pierceable seal 130 and fourth pierceable seal 134, and also the pierceable seal of its respective component.

[0247] As shown in FIG. 3A and FIG. 3C, the second activation mechanism 114 and the fourth activation mechanism 122 each include the protrusion 148 as part of their respective collar 126. An actuator of an activation system (not shown) engages with the protrusion 148 and axially translates the collar 126. In the case of the second activation mechanism 114, the actuator of the activation system (not shown) engages with the protrusion 148 and axially translates the collar 126 downwardly, that is, towards the distal end 104. In the case of the fourth activation mechanism 122, the actuator of the activation system (not shown) engages with the protrusion 148 and axially translates the collar 126 upwardly, that is, towards the proximal end 106. The actuator of the activation system (not shown) may axially translate the respective collar 126 simultaneously or sequentially. Following actuation of the second activation mechanism 114 and the fourth activation mechanism 122, the second fluid pathway is formed through the connector 100, namely between the connected components.

[0248] In the second actuated configuration, as shown in FIG. 3C, a second fluid transfer may be provided between a third component, e.g. at the distal end 104, and the second component (e.g. the same second component discussed in respect of FIG. 3B), e.g. at the proximal end 106.In other examples, a fourth component may be provided, e.g. at the proximal end 106. The second fluid transfer may be effected by a pump, such as a peristaltic pump, or another suitable means for enabling the second fluid transfer. In specific examples, the first component and / or the second component comprises a flexible, such as a compressible, container, and hence the first component and / or the second component may act as a pump.

[0249] Once the second fluid transfer is complete, the second activation mechanism 114 and the fourth activation mechanism 122 are unactuated by operating the second activation mechanism 114 and the fourth activation mechanism 122 in the opposite manner to that discussed above. In this way, the connector 100 returns to its unactuated configuration, as shown in FIG. 3A, in which the second fluid pathway is no longer formed or otherwise blocked or prevented, such that the second fluid transfer (and, generally, a fluid transfer) cannot be provided.

[0250] FIG. 4A illustrates the aseptic seal system 200 of FIG. 1 in more detail. The aseptic seal system 200 is coupled to a pierceable seal 300 described in relation to FIG. 4C, such as the first pierceable seal 128 and the third pierceable seal 132 as shown and discussed in relation to FIG.3A to FIG. 3C. The pierceable seal 300 may be any pierceable seal as described herein.

[0251] The aseptic seal system 200 is configured and arranged to mate with a corresponding aseptic seal system (not shown) on another component, such as a connector, a receptacle, an interface or the like. The aseptic seal system 200 is provided with a housing portion 202, preferably composed of high density polyethylene (HDPE), configured and arranged to detachably couple (for example, clip) to a portion of the housing 102 of the connector 100 (see FIG. 1). The housing portion 202 is provided with an aseptic membrane 204, preferably composed of a polyethylene (PE) film or the like, coupled thereto.

[0252] The housing portion 202 is provided with a pair of substantially parallel lateral rails 206 extending from an upstanding wall 208 at one end to an opening 210 at the opposing end. The upstanding wall 208 is provided with a coupling protrusion 212 that enables coupling to the aseptic membrane 204, for example, by virtue of a friction-fit, heat welding or the like.

[0253] The housing portion 202 is received within a portion of the housing 102 of the connector 100 (see FIG. 1 ), particularly the pair of substantially parallel lateral rails 206 are received within a corresponding track or guide of the housing 102 (see FIG. 1). In this way, the pair of substantially parallel lateral rails 206 are received in a sliding relationship within the housing 102 and are laterally moveable (for example, perpendicular) with respect to the general central longitudinal axis of the connector 100.

[0254] The aseptic membrane 204 is shown in more detail in FIG. 4B. In particular, the aseptic membrane 204 includes a first side 214 and a second side 216. The second side 216 may be sterilised by any known method, such as by UV sterilisation. The second side 216 may be regarded as an aseptic side, or forming an aseptic surface. The second side 216 is provided in contact with a closed end 314 of the pierceable seal 300 (see FIG. 3C) and is arranged to also to mate with a corresponding second, or aseptic side, of a corresponding membrane on a corresponding aseptic seal system (not shown). The second side 216 is afforded with such geometry by virtue of a fold 218 which enables the second side 216 to engage with the respective parts as described.

[0255] Referring to FIG. 4A and FIG. 4B, during use, an actuator of an activation system (not shown - which may be the same, or a different, activation system as described in respect of FIG.3A to FIG. 3C) engages the upstanding wall 208 to cause lateral translation of the housing portion 202 with respect to the housing 102 (see FIG. 1). In particular, the housing portion 202 is engaged such that the pair of substantially parallel lateral rails 206 are substantially removed from the corresponding track or guide of the housing 102 (see FIG. 1). In this way, such lateral translation causes the aseptic membrane 204 to be drawn laterally and removed, particularly such that the second side 216 is removed from the closed end 314 of the pierceable seal 300, thereby exposi ng the closed end 314 (see FIG. 4C). More particularly, during use, the aseptic membrane 204 is coupled to a corresponding aseptic membrane provided over a pierceable seal of a component (not shown), such that each aseptic membrane is removed, and thus enabling an aseptic face-to-face engagement between the pierceable seals.

[0256] FIG. 4C illustrates a detailed view of a pierceable seal 300 that may be used in the connector 100 as described herein, such as the first pierceable seal 128, second pierceable seal 130, third pierceable seal 132 or fourth pierceable seal 134 described in relation to FIG. 3A to FIG.3C. The pierceable seal 300 includes a bellows portion 302 and a static portion 304.

[0257] The bellows portion 302 includes a first wall portion 306 and a second wall portion 308 which are each conical sections angled relative to one another. The first wall portion 306 and the second wall portion 308 extend outwardly from the longitudinal axis of the pierceable seal 300 and together define a V-shape. The first wall portion 306 is connected to the second wall portion 308 by virtue of an outer return 312. The adjacent first wall portion 306 and second wall portion 308 flanking either side of the first wall portion 306 and the second wall portion 308 are connected by an inner return 310. The bellows portion 302 is formed as a number of Z-folds and enables compressibility of the bellows portion 302.

[0258] The bellows portion 302 is connected to the terminating first wall portion 306 of the bellows portion 302. Namely, the bellows portion 302 and the static portion 304 are integrally formed. The static portion 304 remains generally immoveable during use, unlike the bellows portion 302. The static portion 304 includes a closed end 314 which provides a terminating end for the pierceable seal 300. This closed end 314 is pierceable by a piercing member of a fluid conduit as described in relation to FIG. 3A to FIG. 3C.

[0259] During use, the static portion 304 is retained and coupled to a portion of the housing 102 (see FIG. 1), thereby ensuring that the static portion 304 is immoveable - or fixed - during use, whilst the bellows portion 302 is collapsible and extendible as the collar 126 (see FIG. 3A) is axially translated. In this way, the piercing member 144 of each fluid conduit (see FIG. 3B and FIG. 3C) pierces the closed end 314 of the pierceable seal 300 during use.

[0260] FIG. 5 illustrates a method 400 of forming two fluid pathways in a connector, such as the connector 100. In particular, although not exclusively and not intended to be limiting, the method 400 may be a method of using the connector 100.

[0261] As a first step, there is provided a step of activating a first activation mechanism 402, the first activation mechanism being part of the connector, such as that described above. The step of activating a first activation mechanism 402 comprises causing relative movement between a first fluid conduit of the connector and a first valve element of the connector, such that the first fluid conduit operably engages the first valve element to form a first fluid pathway through the connector.

[0262] The step of activating a first activation mechanism 402 generally comprises piercing a first pierceable seal of the connector with a piercing member of the first fluid conduit.

[0263] The step of activating a first activation mechanism 402 may be provided by virtue of an actuator of an activation system (not shown). For example, the step of activating a first activation mechanism 402 comprises engaging an actuator of an activation system (not shown) with the first activation mechanism and activating the first activation mechanism using the activation system.

[0264] As a second step, albeit optionally, there is provided a step of deactivating the first activation mechanism 404. The step of deactivating the first activation mechanism 404 comprises causing relative movement between the first fluid conduit and the first valve element such that the first fluid conduit operably disengages the first valve element to block the first fluid pathway.

[0265] The step of deactivating the first activation mechanism 404 generally comprises removing the piercing member of the first fluid conduit from the pierceable seal of the connector. In this way, the fluid passageway formed (i.e. the first fluid pathway) is removed, prevented or blocked.

[0266] As a third step, there is provided a step of activating a second activation mechanism 406, the second activation mechanism being part of the connector, such as that described above. The step of activating a second activation mechanism 406 comprises causing relative movement between a second fluid conduit of the connector and a second valve element of the connector, such that the second fluid conduit operably engages the second valve element to form a second fluid pathway through the connector.

[0267] The step of activating a second activation mechanism 406 generally comprises piercing a second pierceable seal of the connector with a piercing member of the second fluid conduit.

[0268] The step of activating a second activation mechanisms 406 may be provided by virtue of an actuator of an activation system (not shown). The activation system may be the same, or different, to the activation system acting to provide the step of activating a first activation mechanism 402 as described above. For example, the step of activating a second activation mechanism 406 comprises engaging an actuator of an activation system (not shown) with the second activation mechanism and activating the second activation mechanism using the activation system.

[0269] As a fourth step, albeit optionally, there is provided a step of deactivating the second activation mechanism 408. The step of deactivating the second activation mechanism 408 comprises causing relative movement between the second fluid conduit and the second valve element such that the second fluid conduit operably disengages the second valve element to block the second fluid pathway.

[0270] The step of deactivating the second activation mechanism 408 generally comprises removing the piercing member of the second fluid conduit from the pierceable seal of the connector. In this way, the fluid passageway formed (i.e. the second fluid pathway) is removed, prevented or blocked.

[0271] For completeness, it is noted that the connector discussed in respect of the method of FIG. 5 may be connector 100 described in respect of FIG. 1 to FIG. 3C. As such, there may be further fluid conduits (such as a third fluid conduit and a fourth fluid conduit) and further valve elements (such as a third valve element and a fourth valve element) that operate as part of the method. For example, although not shown in FIG. 5, there may be further steps of activating athird activation mechanism, deactivating the third activation mechanism, activating a fourth activation mechanism, and deactivating the fourth activation mechanism. The steps may be ordered as described or provided in any appropriate order.

[0272] FIGS. 6, 7A and 7B illustrate another embodiment of the connector 600 with a number of fluid pathways through the connector. Features in common with embodiment of the connector 100 illustrated in FIGS. 1 to 3C are depicted with reference numerals beginning with the prefix ‘6’ instead of ‘1 ’ and will not be described further.

[0273] As illustrated in FIG. 6, the connector 600 is rotatable about a central longitudinal axis 608, as shown by arrow A. The housing 602 of the connector 600 has a generally cylindrical shape.

[0274] The connector 600 includes proximal activation mechanisms 610 accessible through proximal windows 612 of the housing 602, and distal activation mechanisms 614 accessible through distal windows 616 of the housing 602. Each proximal window 612 extends along an axis, and is aligned with a corresponding distal window 616 which extends along the same axis.

[0275] An activation system 700 is provided for activating the proximal activation mechanisms 610 and the distal activation mechanisms 614. The activation system 700 includes two external actuators 702. The external actuators 702 are moveable along a first direction, as shown by arrow B, to engage a pair of proximal and distal activation mechanisms 610, 614. The external actuators 702 are also moveable along a second direction, as shown by arrow C, to activate the proximal and distal activation mechanisms 610, 614 to cause the piercing members 644 (shown in FIG. 7A) to pierce the pierceable seal 628 and create a fluid pathway through the connector 600. The connector 600 - such as the housing 602 as discussed below - is rotatable to subsequently align further pairs of proximal and distal activation mechanisms 610, 614 with the external actuators 702, to enable the creation of a number of fluid pathways through the connector 600.

[0276] The external actuators 702 may be controlled independently, so as to independently activate the proximal activation mechanism 610 and the distal activation mechanism 614.Alternatively, the external actuator 702 may be controlled in unison to concurrently activate the proximal activation mechanism 610 and the distal activation mechanism 614.

[0277] To use the connector 600, the connector 600 is rotated to align a pair of proximal and distal activation mechanisms 610, 614 with the external actuators 702 of the activation system 700. In particular, the housing 602 is coupled to each of the piercing members 644, the proximal and distal activation mechanisms 610, 614 and flexible tubes 646 (described below with reference to FIG. 7A), and the housing 602 is rotatable. In other examples, each of the piercingmembers 644, the proximal and distal activation mechanisms 610, 614 and flexible tubes 646 (described below with reference to FIG. 7A) are provided on an internal carousel that is rotatable with respect to the housing 602. For example, such internal carousel may be rotated by the activation mechanism 700.

[0278] The external actuators 702 are then actuated to the engage the pair of proximal and distal activation mechanisms 610, 614 and to activate them to cause the piercing members 644 (shown in FIG. 7A) connected to each of the proximal and distal activation mechanisms 610, 614 to pierce the respective pierceable seal 628 and create a first fluid pathway through the connector 600. The external actuators 702 are then actuated to deactivate the pair of proximal and distal activation mechanisms 610, 614 to block, or otherwise prevent, the first fluid pathway, and then disengage from the proximal and distal activation mechanisms 610, 614. The connector 600 can then be rotated to align another pair of proximal and distal activation mechanisms 610, 614 with the external actuators 702 which can be activated to create a second fluid pathway through the connector 600. Further rotation of the connector 600 and activation of the proximal and distal activation mechanisms 610, 614 can create third, fourth, fifth, and subsequent fluid pathways through the connector 600. It will be appreciated that any suitable number of fluid pathways may be provided through the connector, and the same pair of proximal and distal activation mechanisms 610, 614 may be actuated two or more times.

[0279] It will also be appreciated by the skilled person that the activation system 700 may alternately or additionally be moveable about the connector 600 to align the external actuators 702 with a desired pair of proximal and distal activation mechanisms 610, 614. The activation system 700 will be moveable about a circular path around the connector 600 and rotatable to allow the external actuators 702 to align, and engage, with the proximal and distal activation mechanisms 610, 614. In such an example, it is not necessary for the connector 600 to be rotatable, although it may be rotatable in addition to the activation system 700 being moveable or rotatable about the connector 600.

[0280] FIG. 7A shows a partial cross-sectional view of the connector 600. The connector 600 is shown in an unactuated configuration. The connector 600 has a number of proximal activation mechanisms 610, distal activation mechanisms 614, piercing members 644 and flexible tubes 646 positioned within the housing 602 and radially about a central longitudinal axis 608 of the connector 600. Although not shown, each piercing member 644 may be isolated from each adjacent piercing member 644, for example by an internal collapsible wall element, so as to maintain sterility of each of the piercing members 644.

[0281] FIG. 7B shows a top and bottom view of the connector 600. Proximal and distal ends of the housing 602 include a pierceable seal 628. The pierceable seal 628 is in the shape of an annulus. The pierceable seal 628 is positioned along an outer circumferential section of the proximal and distal ends of the housing 602. Each of the piercing members 644 (shown in FIG. 7B) are arranged to face the pierceable seal 628 at their respective proximal or distal end, such that activation of the proximal activation mechanism 610 and / or the distal activation mechanism 614 will cause the piercing member 644 connected thereto to pierce the pierceable seal 628. In other examples, although not illustrated, there may be provided a series of pierceable seals, each corresponding to a piercing member 644, positioned circumferentially around each of the proximal and distal ends of the housing 602.

[0282] As shown in FIG. 8, there is provided a connector 800 including a housing 802 that generally extends between a distal end 804 and a proximal end 806. The housing 802 is provided so that a first component (not shown) is connectable to a connection element 808 at the distal end 804 and a second component (not shown) and a third component (not shown) are connectable to the proximal end 806. The first, second and third components may be coupled to the connector 800 in any known manner. For example, the connection element 808 is provided with a threaded portion for coupling with corresponding threads of a first component, although other mechanisms of coupling are equally contemplated. The connection element 808 depicted includes anti-rotational threads at its uppermost, distal, end to prevent unintended decoupling of the component (not shown) from the connection element 808 during use.

[0283] The housing 802 has a static portion 810, a selection portion 812 and a flexible wall 814. The selection portion 812 is moveable with respect to the static portion 810. Specifically, the static portion 810 has a rounded surface 816 facing the selection portion 812. The selection portion 812 has a corresponding rounded surface 818 facing the static portion 810. These corresponding rounded surfaces 816, 818 permit the selection portion 812 to slide along the proximal end 806 of the static portion 810 of the housing 802 in a direction substantially perpendicular to a longitudinal axis of the housing 802. The selection portion 812 is slidable in the directions indicated by arrow A.

[0284] The flexible wall 814 is connected at one end to the static portion 810 and at the other end to the selection portion 812. The flexible wall 814 encloses gaps between the static portion 810 and the selection portion 812 so that an internal volume 836 of the housing 802 is closed to the external environment. The flexible wall 814 is a bellows wall having a concertina arrangement that allows the flexible wall 814 to fold onto itself in order to collapse. In particular, the flexiblewall 814 may comprise a series of alternately arranged inward folds and outward folds that allow the flexible wall 814 to collapse like a bellows or concertina. Each side of the flexible wall 814 can therefore expand and contract as the selection portion 812 is moved with respect to the static portion 810.

[0285] The selection portion 812 has a conical-shaped proximal wall 832 and a side wall 834 which define an internal volume 836 of the selection portion 812. A first valve element 826 and a second valve element 828 are provided in the selection portion 812. The first valve element is a first pierceable seal 826 and the second valve element is a second pierceable seal 828. The first pierceable seal 826 and the second pierceable seal 828 are provided in the proximal wall 832 of the selection portion 812. The first pierceable seal 826 and the second pierceable seal 828 spaced apart from one another in the selection portion 812.

[0286] The selection portion 812 is provided with a selection mechanism (not shown). The selection mechanism may be a protrusion engageable by an actuator of a selection system (not shown). Activation of the selection mechanism will cause the selection portion 812 to move between a first configuration and a second configuration in use. In the first configuration, the selection portion 812 is in a first position with respect to the static portion 810. In the second configuration, the selection portion 812 is in a second position with respect to the static portion 810.

[0287] A third valve element 830 is provided in the connection element 808. The third valve element is a third pierceable seal 830. The connection element 808 is axially translatable and hence enables translation of the third pierceable seal 830, during use. The connection element 808 is mounted within the distal end 804 of the housing 802. The connection element 808 is slidably mounted to an inner surface of the housing 802 such that it is slidable along the axial direction of the housing 802. The connection element 808 has an activation mechanism 824. The activation mechanism 824 has openings for receiving an actuator of an activation system (not shown). In some embodiments, the activation mechanism 824 protrudes through a window (not shown) of the housing 802 and is engageable by the actuator of the activation system. The actuator is operable to enable axial translation of the connection element 808 within the housing 802. It will be appreciated that the selection system and the activation system may be the same system controllable to actuate each of the selection mechanism and the activation mechanism 824. Alternatively, each of the selection system and the activation system may be distinct systems.

[0288] A hollow needle 820 is mounted in the housing 802 by a collar 822. The collar 822 is axially translatable and hence enables translation of the hollow needle 820, during use.Specifically, the collar 822 is slidably mounted to an inner surface of the static portion 810 of the housing 802 such that it is slidable along the axial direction of the housing 802. The hollow needle 820 is a double-ended hollow needle having a first end 820a facing the distal end 804 of the housing 802 and a second end 820b facing the proximal end 806 of the housing 802. The first end 820a of the hollow needle 820 faces the third pierceable seal 830 and the second end 820b of the hollow needle 820 faces the selection portion 812.

[0289] The collar 822 is engageable by the activation mechanism 824. Actuation of the activation mechanism 824 to axially translate the connection element 808 towards the proximal end 806 of the housing 802 causes the activation mechanism 824 to engage the collar 822.Further actuation of the activation mechanism 824 to axially translate the connection element 808 towards the proximal end 806 will also cause axial translation of collar 822 towards the proximal end 806 and consequently cause the hollow needle 820 to move towards the proximal end 806 of the housing 802.

[0290] Axial translation of the connection element 808 by the activation mechanism 824 towards the proximal end 806 of the housing 802 will cause the first end 820a of the hollow needle 820 to pierce the third pierceable seal 830, in use. Piercing of the third pierceable seal 830 by the first end 820a of the hollow needle 820 forms a first fluid flow path through the hollow needle 820 and the third pierceable seal 830. Axial translation of the collar 822 towards the proximal end 806 of the housing 802 will cause the second end 820b of the hollow needle 820 to pierce the first pierceable seal 826 or the second pierceable seal 828, in use. Piercing of the first pierceable seal 826 or the second pierceable seal 828 by the second end 820b of the hollow needle 820 forms a second fluid flow path through the hollow needle 820 and the first pierceable seal 826 or the second pierceable seal 828.

[0291] The first and second pierceable seals 826, 828 include a static sleeve portion having a closed end which provides a terminating end for the pierceable seal 826, 828. This closed end is pierceable by the hollow needle 820. During use, the static sleeve portion is retained and coupled to the proximal wall 832 of the selection portion 812 of the housing 802, thereby ensuring that the static sleeve portion is immoveable - or fixed - during use. In this way, the hollow needle 820 pierces the closed end of the first and / or second pierceable seal 826, 828 during use.

[0292] Two aseptic seal systems (not shown) may be provided at the proximal end 806 to seal the first and second pierceable seals 826, 828. Each aseptic seal system may be coupled to arespective one of the first pierceable seal 826 and the second pierceable seal 828. The aseptic seal system is configured and arranged to mate with a corresponding aseptic seal system on another component, such as a connector, a receptacle, an interface or the like.

[0293] A collapsible sleeve 838 is coupled between a distal end of the side wall 834 of the selection portion 812 and the collar 822. The collapsible sleeve 838 is a bellows sleeve. The collapsible sleeve 838 is formed as a number of Z-folds which enables compressibility of the collapsible sleeve 838. During use, the collapsible sleeve 838 is collapsible and extendible as the collar 822 is axially translated. In this way, the hollow needle 820 pierces the closed end of the first pierceable seal 826 or the second pierceable seal 828 during use.

[0294] The third pierceable seal 830 includes a collapsible sleeve portion 840 and static sleeve portion 842. The collapsible sleeve portion 840 is a bellows sleeve. The collapsible sleeve portion 840 is formed as a number of Z-folds which enables compressibility of the collapsible sleeve portion 840. The static sleeve portion 842 is connected to an end of the collapsible sleeve portion 840. Namely, the collapsible sleeve portion 840 and the static sleeve portion 842 are integrally formed. The static sleeve portion 842 remains generally immoveable during use, unlike the collapsible sleeve portion 840. The static sleeve portion 842 includes a closed end which provides a terminating end for the third pierceable seal 830. This closed end is pierceable by the hollow needle 820. During use, the static sleeve portion 842 is retained and coupled to the connection element 808, thereby ensuring that the static sleeve portion 842 is immoveable - or fixed - during use, whilst the collapsible sleeve portion 840 is coupled between the connection element 808 and the collar 822 and is collapsible and extendible as the connection element 808 is axially translated. In this way, the hollow needle 820 pierces the closed end of the third pierceable seal 830 during use.

[0295] As shown in FIG. 8, the connector 800 is in a neutral unactuated configuration. The first end 820a of the hollow needle 820 is facing the third pierceable seal 830 and the second end 820b is facing the selection portion 812, the hollow needle 820 has not pierced any of the first, second or third pierceable seals 826, 828, 830. The selection portion 812 in FIG. 8 is in a neutral position in which the second end 820b of the hollow needle 820 is not coaxially aligned with the first pierceable seal 826 or the second pierceable seal 828. It will be appreciated that the hollow needle 820 is not coaxially aligned with the first pierceable seal 826 or the second pierceable seal 828 when the hollow needle 820 is in a position in which it not make contact with, or pierce, any portion of either of the first pierceable seal 826 or the second pierceable seal 828 when the hollow needle 820 is moved in an axial direction towards the proximal end 806 of the housing 802.The second end 820b of the hollow needle 820 is facing the proximal wall 832 of the selection portion 812 between the first pierceable seal 826 and the second pierceable seal 828.

[0296] FIG. 9A shows the connector 800 of FIG. 8 in a first unactuated configuration. The selection mechanism (not shown) has been actuated to move the selection portion 812 to a first configuration in which the hollow needle 820 is coaxially aligned with the first pierceable seal 826. Specifically, the selection mechanism has been actuated to slide the selection portion 812 in the direction of arrow A to bring the first pierceable seal 826 into coaxial alignment with the second end 820b of the hollow needle 820. It will be appreciated that the first pierceable seal 826 is coaxially aligned with the hollow needle 820 when the first pierceable seal 826 is in a position in which the hollow needle 820 will make contact with, or pierce, any portion of the first pierceable seal 826 when the hollow needle 820 is moved in an axial direction towards the proximal end 806 of the housing 802. Similar to the neutral unactuated configuration of FIG. 8, the activation mechanism has not been actuated and the hollow needle 820 has not pierced any of the first, second or third pierceable seals 826, 828, 830.

[0297] The selection mechanism (not shown) has a protrusion, an opening or another suitable element engageable by an actuator. An actuator of a selection system (not shown) engages with the selection mechanism and slides the selection portion 812. Specifically, the actuator of the selection system (not shown) engages the selection system and translates the selection portion 812 to the right, that is, towards one side of the selection portion 812 in the direction of arrow A. This translation of the selection portion 812 moves the first pierceable seal 826 relative to the second end 820b of the hollow needle 820, bringing the first pierceable seal 826 into coaxial alignment with the hollow needle 820.

[0298] FIG. 9B shows the connector 800 of FIG. 8 in a first actuated configuration. The selection portion 812 is in the first configuration as shown in FIG. 9A. The activation mechanism 824 has been actuated to axially translate the connection element 808 and the collar 822 in the direction of arrow B towards the proximal end 806 of the housing 802. The first end 820a of the hollow needle 820 has pierced the third pierceable seal 830. The second end 820b of the hollow needle 820 has pierced the first pierceable seal 826. In this first actuated configuration, the activation mechanism 824 has been actuated to provide a first fluid pathway formed through the hollow needle 820, the first pierceable seal 826 and the third pierceable seal 830. In this way, the first fluid pathway is provided between a component connected to the connection element 808 at the distal end 804 of the connector 800, and another component connected to the proximal end 806 of the connector 800, specifically adjacent the first pierceable seal 826.

[0299] Each component (not shown) at the distal end 804 and the proximal end 806 may be provided with a pierceable seal. In this way, hollow needle 820 pierces through the first pierceable seal 826 and the third pierceable seal 830, and also the pierceable seal of its respective component.

[0300] As shown in FIG. 9A and 9B, the activation mechanism 824 has an opening. An actuator of an activation system (not shown) engages with the opening of the activation mechanism 824 and axially translates the connection element 808. Specifically, the actuator of the activation system (not shown) engages the activation mechanism 824 and axially translates the connection element 808 downwardly, that is, towards the distal end 804 in the direction of arrow B. This axial translation of the connection element 808 moves the third pierceable seal 830 relative to the first end 820a of the hollow needle 820, causing the first end 820a to pierce the third pierceable seal 830 and forms the first fluid flow path. The actuator of the activation mechanism (not shown) remains engaged with the activation mechanism 824 and further axially translates the connection element 808 downwardly. The activation mechanism 824 engages the collar 822 and axially translates the collar 822 downwardly, that is, towards the distal end 804 in the direction of arrow B. This axial translation of the collar 822 moves the second end 820b of the hollow needle 820 relative to the first pierceable seal 826, causing the second end 820b to pierce the first pierceable seal 826 and forms the second fluid flow path. Following actuation of the activation mechanism 824, the connector 800 is in the actuated configuration as shown in FIG. 9B, and the first fluid pathway is formed through the connector 800, namely between the connected components.

[0301] In the first actuated configuration, as shown in FIG. 9B, a first fluid transfer may be provided between a first component, e.g. at the distal end 804, and a second component, e.g. at the proximal end 806, specifically adjacent to the first pierceable seal 826. The first fluid transfer may be effected by a pump, such as a peristaltic pump, or another suitable means for enabling the first fluid transfer. In specific examples, the first component and / or the second component comprises a flexible, such as a compressible, container, and hence the first component and / or the second component may act as a pump.

[0302] Once the first fluid transfer is complete, the activation mechanism 824 is unactuated by operating the activation mechanism 824 in the opposite manner to that discussed above. In this way, the connector 800 returns to the unactuated configuration, as shown in FIG. 9A, in which the first fluid pathway is no longer formed, such that the first fluid transfer (and, generally, a fluid transfer) cannot be effected.

[0303] It will be appreciated that the collar 822 may be biased towards the unactuated configuration. In other words, the collar 822 may be biased towards the distal end 804 of the housing 802. Accordingly, operation of the activation mechanism 824 in the opposite manner permits the collar 822 to return to the unactuated configuration. Alternatively, the collar 822 may be provided with a second activation mechanism engageable by an actuator of the activation system. Accordingly, the collar 822 can be actuated by the actuator to move the collar 822 between the actuated configuration and the unactuated configuration.

[0304] FIG. 9C shows the connector 800 of FIG. 8 in a second unactuated configuration. The selection mechanism (not shown) has been actuated to move the selection portion 812 from the first configuration shown in FIG. 9A to the second configuration in which the hollow needle 820 is coaxially aligned with the second pierceable seal 828. Specifically, the selection mechanism has been actuated to slide the selection portion 812 in the direction of arrow A to bring the second pierceable seal 828 into coaxial alignment with the second end 820b of the hollow needle 820. It will be appreciated that the second pierceable seal 828 is coaxially aligned with the hollow needle 820 when the second pierceable seal 828 is in a position in which the hollow needle 820 will make contact with, or pierce, any portion of the second pierceable seal 828 when the hollow needle 820 is moved in an axial direction towards the proximal end 806 of the housing 802. The activation mechanism has not been actuated and the hollow needle 820 has not pierced any of the first, second or third pierceable seals 826, 828, 830.

[0305] The actuator of a selection system (not shown) engages with the selection mechanism and slides the selection portion 812. Specifically, the actuator of the selection system (not shown) engages the selection system and translates the selection portion 812 to the left, that is, towards the other side of the selection portion 812 in the direction of arrow A. This translation of the selection portion 812 moves the second pierceable seal 828 relative to the second end 820b of the hollow needle 820, bringing the second pierceable seal 828 into coaxial alignment with the hollow needle 820.

[0306] FIG. 9D shows the connector 800 of FIG. 8 in a second actuated configuration. The selection portion 812 is in the second configuration as shown in FIG. 9C. The activation mechanism 824 has been actuated to axially translate the connection element 808 and the collar 822 in the direction of arrow B. The first end 820a of the hollow needle 820 has pierced the third pierceable seal 830 and the second end 820b has pierced the second pierceable seal 828. In this second actuated position, the activation mechanism 824 has been actuated to provide a second fluid pathway formed through the hollow needle 820, the second pierceable seal 828 and thethird pierceable seal 830. In this way, the second fluid pathway is provided between a component connected to the connection element 808 at the distal end 804 of the connector 800, and another component connected to the proximal end 806 of the connector 800, specifically adjacent the second pierceable seal 828.

[0307] Each component (not shown) at the distal end 804 and the proximal end 806 may be provided with a pierceable seal. In this way, hollow needle 820 pierces through the second pierceable seal 828 and the third pierceable seal 830, and also the pierceable seal of its respective component.

[0308] The activation mechanism 824 is actuated in the same way as described with respect to FIG. 9B. This axial translation of the collar 822 moves the second end 820b of the hollow needle 820 relative to the second pierceable seal 828, causing the second end 820b to pierce the second pierceable seal 828 and forms the second fluid flow path. Following actuation of the activation mechanism 824, the connector is in the actuated configuration as shown in FIG. 9D, and the second fluid pathway is formed through the connector 800, namely between the connected components.

[0309] In the second actuated configuration, as shown in FIG. 9B, a second fluid transfer may be provided between the first component, e.g. at the distal end 804, and the second component (e.g. the same second component discussed in respect of FIG. 9B). In other examples, a third component may be provided, e.g. at the proximal end 806, specifically adjacent to the second pierceable seal 828. The second fluid transfer may be effected by a pump, such as a peristaltic pump, or another suitable means for enabling the first fluid transfer. In specific examples, the first component, the second component and / or the third component comprises a flexible, such as a compressible, container, and hence the first component, the second component and / or the third component may act as a pump.

[0310] Once the second fluid transfer is complete, the activation mechanism 824 is unactuated by operating the activation mechanism 824 in the opposite manner. In this way, the connector 800 returns to the unactuated configuration, as shown in FIG. 9C, in which the second fluid pathway is no longer formed, such that the second fluid transfer (and, generally, a fluid transfer) cannot be effected.

[0311] Accordingly, the connector 800 as shown in FIG. 9A to FIG. 9D allows for a dual connection at one end of the connector. Specifically, the connector 800 is capable of selectively connecting a first component to each of a second and a third component.

[0312] FIG. 3 illustrates a method 1000 of forming two fluid pathways in a connector, such as the connector 800. In particular, although not exclusively and not intended to be limiting, the method 1000 may be a method of using the connector 800.

[0313] As a first step, there is provided a step of activating a selection mechanism to a first configuration 1002, the selection mechanism being a part of the connector, such as that described above. The step of activating a selection mechanism to a first configuration 1002 comprises causing relative movement between a first valve element at a first end of the connector and a fluid conduit to coaxially align the first valve element with the fluid conduit.

[0314] The step of activating a selection mechanism to a first configuration 1002 generally comprises activating the selection mechanism to slide a selection portion of the connector housing including the first valve element relative to a static portion of the connector housing to bring the first valve element into coaxial alignment with the fluid conduit.

[0315] The step of activating a selection mechanism to a first configuration 1002 may be provided by virtue of an actuator of a selection system (not shown). For example, the step of activating a selection mechanism to a first configuration 1002 comprises engaging an actuator of a selection system (not shown) with the selection mechanism and activating the selection mechanism using the selection system.

[0316] As a second step, there is provided a step of activating an activation mechanism 1004, the activation mechanism being part of the connector, such as that described above. The step of activating an activation mechanism 1004 comprises causing relative movement between the fluid conduit and the first valve element, such that the fluid conduit operably engages the first valve element to form a first fluid pathway through the connector.

[0317] The step of activating an activation mechanism 1004 generally comprises piercing a first pierceable seal of the connector with a hollow needle that forms the fluid conduit.

[0318] The step of activating an activation mechanism 1004 may be provided by virtue of an actuator of an activation system (not shown). For example, the step of activating an activation mechanism 1004 comprises engaging an actuator of an activation system (not shown) with the activation mechanism and activating the activation mechanism using the activation system.

[0319] As a third step, there is provided a step of deactivating the activation mechanism 1006. The step of deactivating the activation mechanism 1006 comprises causing relative movement between the fluid conduit and the first valve element such that the fluid conduit operably disengages the first valve element to block the first fluid pathway.

[0320] The step of deactivating the activation mechanism 1006 generally comprises removing the hollow needle from the first pierceable seal of the connector. In this way, the fluid passageway formed (i.e. the first fluid pathway) is removed, prevented or blocked.

[0321] As a fourth step, there is provided a further step of activating the selection mechanism to a second configuration 1008. The step of activating the selection mechanism to a second configuration 1008 comprises causing relative movement between a second valve element at the first end of the connector and the fluid conduit to coaxially align the second valve element with the fluid conduit.

[0322] The step of activating the selection mechanism to a second configuration 1008 generally comprises activating the selection mechanism to slide the selection portion of the connector housing including the first valve element and the second valve element relative to the static portion of the connector housing to bring the second valve element into coaxial alignment with the fluid conduit. The selection mechanism is activated to slide in a direction opposite to the direction the selection mechanism is slid in the step of activating a selection mechanism to a first configuration 1002.

[0323] As a fifth step, there is provided a further step of activating the activation mechanism 1010. The step of activating the activation mechanism 1010 comprises causing relative movement between the fluid conduit and the second valve element, such that the fluid conduit operably engages the second valve element to form a second fluid pathway through the connector.

[0324] The step of activating the activation mechanism 1010 generally comprises piercing a second pierceable seal of the connector with the hollow needle.

[0325] As a sixth step, albeit optionally, there is provided a further step of deactivating the activation mechanism 1012. The step of deactivating the activation mechanism comprises causing relative movement between the fluid conduit and the second valve element such that the fluid conduit operably disengages the second valve element to block the second fluid pathway.

[0326] The step of deactivating the activation mechanism 1012 generally comprises removing the hollow needle from the second pierceable seal of the connector. In this way, the fluid passageway formed (i.e. the second fluid pathway) is removed, prevented or blocked.

[0327] As a seventh step, albeit optionally, there is provided a yet a further step of activating the selection mechanism to a neutral first configuration 1014. The step of activating the selection mechanism to a neutral first configuration 1014 comprises causing relative movement betweenthe fluid conduit, the first valve element and the second valve element to coaxially displace the fluid conduit from each of the first valve element and the second valve element.

[0328] The step of activating the selection mechanism to a second configuration 1008 generally comprises activating the selection mechanism to slide the selection portion of the connector housing including the first valve element and the second valve element relative to the static portion of the connector housing to a position in which the fluid conduit faces the proximal wall of the selection portion 812. The selection mechanism is activated to slide in a direction opposite to the direction the selection mechanism is slid in the step of activating the selection mechanism to a second configuration 1008.

[0329] Whilst the connector 100 is described as having four fluid conduits, four pierceable seals, and four activation mechanisms, and two fluid pathways through the connector, the skilled person will appreciate that the number of fluid conduits, pierceable seals, activation mechanisms and fluid pathways may vary appropriately. For example, in some examples, two fluid conduits may be provided, each with a respective activation mechanism, a distal end of each of the fluid conduits facing a first pierceable seal at one end (e.g. a distal end 104) of the housing 102, and a proximal end of each of the fluid conduits facing a second pierceable seal at the other end (e.g. a proximal end 106) of the housing 102. Accordingly, a single pierceable seal can be pierced in different positions by each of the piercing members at the same end of the housing. Furthermore, the pierceable seal may be a self-sealing seal, such as a self-sealing septum seal, that can be pierced two or more times in the same position by a piercing member to permit multiple connections through the same fluid conduit. In yet other examples, there may be further fluid pathways formed through the connector, such as a third fluid pathway, a fourth fluid pathway etc., to enable the desired number of fluid pathways through the connector and to various connected components. Likewise, other examples are contemplated within the scope of this disclosure.

[0330] The skilled person will also appreciate that the activation system (not shown) may have four actuators, each actuator corresponding to a respective activation mechanism (110, 114, 118, 122). Alternatively, the activation system may have two actuators, each actuator arranged to actuate two activation mechanisms (e.g. the first activation mechanism 110 and the third activation mechanism 118, or the second activation mechanism 114 and the fourth activation mechanism 122) so as to provide a fluid pathway through the connector 100. In yet other embodiments, the connector 100, 600, or a part thereof, may rotatable or otherwise moveable to align an activation mechanism with a corresponding actuator. For example, connector 100, 600may have a number of fluid conduits, pierceable seals and activation mechanisms such that it is capable of forming a plurality of fluid pathways through the connector, the activation system may have two actuators, and a part of the connector 100, 600 is rotatable to align a pair of opposing activation mechanisms with the two actuators.

[0331] The valve elements described herein are pierceable seals 128, 130, 132, 134, 300, 628, 826, 828, 830. However, it will be appreciated that the valve elements may alternatively be any suitable valve element, for example a valve moveable between an open and a closed position. Specifically, the valve may be a plug valve, a butterfly valve, a gate valve, a diaphragm valve, or any other suitable valve.

[0332] The fluid conduit of the connector 800 is described herein as a double-ended hollow needle 820. However, it will be appreciated that the fluid conduit may be a needle having only a single pointed end. Alternatively, the fluid conduit may be any suitable fluid conduit for conveying a fluid through the connector 800, for example the fluid conduit may be a flexible or a rigid tube.

[0333] The selection portion 812 of the housing 802 of the connector 800 described herein is slidable with respect to the static portion 810. However, it will be appreciated that the selection portion 812 may be otherwise movable with respect to the static portion 810 to move each of the first and second valve elements 826, 828 into, and out of, alignment with the hollow needle 820. For example, the selection portion 812 may be rotatable. In another example, the selection portion 812 may be pivotable. Yet further, the first and second valve elements 826, 828 are described as being movable, and can be actuated to move with respect to the hollow needle 820. Specifically, the first and second valve elements 826, 828 are provided in the selection portion 812 which is movable and can be actuated to move with respect to the hollow needle 820.However, it will be appreciated that the hollow needle 820 may alternatively be movable, and can be actuated to move with respect to the first and second valve elements 826, 828.

[0334] The connector 800 is described herein as having first and second pierceable seals 826, 828 at the proximal end 806 and a third pierceable seal 830 at the distal end 804. However, it will be appreciated that only one pierceable seal may be provided at the proximal end 806, and the pierceable seal may be movable such that the hollow needle 820 can coaxially align with a first portion of the pierceable seal and a second portion of the pierceable seal. Accordingly, the hollow needle 820 can pierce different portions of the pierceable seal to create different flow paths through the pierceable seal. Furthermore, the pierceable seal may be a self-sealing seal, such as a self-sealing septum seal, that can be pierced two or more times in the same position by a piercing member to permit multiple connections through the same fluid conduit. It will also beappreciated that any number of valve elements, for example pierceable seals, may be provided at the proximal end 806 of the housing 802. Specifically, any number of valve elements may be provided in the selection portion 812 of the housing 802. For example, three, four, five, six, or more valve elements may be provided at the proximal end 806 of the housing 802. Yet further, it will be appreciated that the distal end 804 of the housing 802 may not be provided with a pierceable seal. Instead, the distal end 804 of the housing 802 and the first end 820a of the fluid conduit may be fluidly coupled to a component. It will also be appreciated that a second selection portion may be provided at the distal end 804 of the housing 802 that is movable with respect to the static portion 810. The second selection portion may have two or more valve elements that are moveable to be coaxially aligned with the first end 820a of the hollow needle 820.

[0335] Further, whilst the connectors 100, 600, 800 are described as connecting three components (a first component to a second component, and a third component to the second component), any appropriate number of components may be utilised. For example, the connector 100, 600, 800 may be utilised to connect a first component to a second component, disconnect such components, and then reconnect the first component and the second component. Likewise, the first component and the second component may be connected, disconnected, and then further (new) components, such as a third component and a fourth component, may be connected. Likewise, other examples are contemplated within the scope of this disclosure.

[0336] As will be appreciated by persons skilled in the art, the parts of the connector 100, 600, 800 may be composed of any suitable material. For example: the aseptic seal system may include a housing portion composed of high density polyethylene (HDPE) and / or an aseptic membrane composed of polyethylene (PE); the collar may be composed of polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS); the fluid conduit may be composed of stainless steel or another appropriate biocompatible material or metal; the pierceable seal may be composed of low density polyethylene (LDPE), polypropylene (PP), a thermoplastic elastomer (TPE), a silicon or the like; the pierceable seal may be co-moulded with a portion of the housing. Any combination of materials is also envisaged as discussed above. Such materials provide multiple manufacturing and processing advantages, in addition to being suitable for cell and / or gene therapy manufacture.

[0337] Generally, it will be appreciated by persons skilled in the art that the above embodiments have been described by way of an example only and not in any limitative sense, andthat various alternations and modifications are possible without departing from the scope of the invention as defined by the appended claims. Various modifications to the detailed designs as described above are possible, for example, variations may exist in shape, size, arrangement, assembly, sequence or the like.

[0338] Certain implementations are described in the following numbered clauses:Clause A1 . A connector, comprising:a housing extending between a distal end and a proximal end;a first fluid conduit provided at least partially within the housing, a first end of the first fluid conduit being fluidly connected to, or fluidly connectable to, a component, and a second end of the first fluid conduit operably engageable with a first valve element at one of the distal end and the proximal end of the housing;a first activation mechanism operable to cause relative movement between the first fluid conduit and the first valve element to enable the first fluid conduit to operably engage the first valve element, thereby providing a first fluid flow path through the first fluid conduit and the first valve element;a second fluid conduit provided at least partially within the housing, a first end of the second fluid conduit being fluidly connected to, or fluidly connectable to, a component, and a second end of the second fluid conduit operably engageable with a second valve element at one of the distal end and the proximal end; anda second activation mechanism operable to cause relative movement between the second fluid conduit and the second valve element to enable the second fluid conduit to operably engage the second valve element thereby providing a second fluid flow path through the second fluid conduit and the second valve element,wherein the first activation mechanism and the second activation mechanism are independently operable.Clause A2. The connector of clause A1, wherein the first valve element and the second valve element are the same valve element.Clause A3. The connector of clause A1, wherein the first valve element and the second valve element are distinct valve elements.Clause A4. The connector of any one of clauses A1 to A3, wherein each of the distal end and the proximal end of the housing comprise at least one valve element.Clause A5. The connector of any one of clauses A1 to A4, wherein the first valve element and the second valve element comprise a pierceable seal, and wherein each of the second end of the first fluid conduit and the second end of the second fluid conduit comprise a piercing member.Clause A6. The connector of clause A5, wherein each end of the first fluid conduit comprises a piercing member, and wherein each piercing member of the first fluid conduit faces a pierceable seal at each end of the housing.Clause A7. The connector of clause A5 or A6, wherein each end of the second fluid conduit comprises a piercing member, and wherein each piercing member of the second fluid conduit faces a pierceable seal at each end of the housing.Clause A8. The connector of any one of clauses A5 to A7, wherein the proximal end of the housing comprises the first pierceable seal and the second pierceable seal, the second end of the first fluid conduit facing the first pierceable seal, and the second end of the second fluid conduit facing the second pierceable seal.Clause A9. The connector of clause A8, wherein:the first activation mechanism is operable to cause relative movement between the first fluid conduit and the first pierceable seal to enable the piercing member of the first fluid conduit to pierce the first pierceable seal and form the first fluid flow path through the first fluid conduit and the first pierceable seal; andthe second activation mechanism is operable to cause relative movement between the second fluid conduit and the second pierceable seal to enable the piercing member of the second fluid conduit to pierce the second pierceable seal and form the second fluid flow path through the second fluid conduit and the second pierceable seal.Clause A10. The connector of clause A8 or A9, wherein the distal end of the housing comprises a third pierceable seal.Clause A11 . The connector of clause A10, wherein each of the first end of the first fluid conduit and the first end of the second fluid conduit comprises a piercing member that faces the third pierceable seal.Clause A12. The connector of clause A10, further comprising:a third fluid conduit mounted at least partially between the distal end and the proximal end of the housing, a first end of the third fluid conduit fluidly connected to the first end of the first fluid conduit, and a second end of the third fluid conduit facing the third pierceable seal, the second end of the third fluid conduit comprising a piercing member;a third activation mechanism operable to cause relative movement between the third fluid conduit and the third pierceable seal to enable the piercing member of the third fluid conduit to pierce the third pierceable seal and form a third fluid flow path through the third fluid conduit and the third pierceable seal;wherein the first activation mechanism, the second activation mechanism, and the third activation mechanism are each independently operable.Clause A13. The connector of clause A12, wherein the first end of the third fluid conduit is fluidly connected to the first end of the first fluid conduit by a tube, such as a flexible tube.Clause A14. The connector of any one of clauses A10 to A13, wherein the distal end of the housing comprises a fourth pierceable seal.Clause A15. The connector of clause A14, wherein the first end of the first fluid conduit faces the third pierceable seal, and wherein the first end of the second fluid conduit faces the fourth pierceable seal.Clause A16. The connector of clause A14, further comprising:a fourth fluid conduit mounted at least partially between the distal end and the proximal end of the housing, a first end of the fourth fluid conduit fluidly connected to the first end of the second fluid conduit, and a second end of the fourth fluid conduit facing the fourth pierceable seal, the second end of the fourth fluid conduit comprising a piercing member;a fourth activation mechanism operable to cause relative movement between the fourth fluid conduit and the fourth pierceable seal to enable the piercing member of the fourth fluid conduit to pierce the fourth pierceable seal and form a fourth fluid flow path through the fourth fluid conduit and the fourth pierceable seal;wherein the first activation mechanism, the second activation mechanism, the third activation mechanism, and the fourth activation mechanism are each independently operable.Clause A17. The connector of clause A16, wherein the first end of the fourth fluid conduit is fluidly connected to the first end of the second fluid conduit by a tube, such as a flexible tube.Clause A18. The connector of any one of clauses A1 to A17, wherein each respective activation mechanism comprises an axially moveable collar coupled to the respective fluid conduit.Clause A19. The connector of clause A18, wherein the collar comprises one or more protrusions engageable by an actuator of an activation system.Clause A20. The connector of any one of clauses A1 to A19, wherein the connector is an aseptic connector.Clause A21 . A sterile package or a sterile container comprising the connector of any one of clauses A1 to A19.Clause A22. A kit of parts, comprising:a connector according to any one of clauses A1 to A20;a first component connectable to the distal end of the housing; anda second component connectable to the proximal end of the housing.Clause A23. An apparatus, comprising:a connector according to any one of clauses A1 to A20;a first component connected to the distal end of the housing; anda second component connected to the proximal end of the housing.Clause A24. The kit of parts of clause A22 or the apparatus of clause A23, wherein the first component and / or the second component comprises an interface coupled to a container or a container.Clause A25. A system, comprising:a connector according to any one of clauses A1 to A20, or the apparatus of clause A23;an activation system configured to operably engage with the first activation mechanism to cause relative movement between the first fluid conduit and the first valve element, and further configured to operably engage with the second activation mechanism to cause relative movement between the second fluid conduit and the second valve element.Clause A26. A method of forming two fluid pathways in a connector, comprising:activating a first activation mechanism to cause relative movement between a first fluid conduit and a first valve element such that the first fluid conduit operably engages the first valve element to form a first fluid pathway through the connector; andactivating a second activation mechanism to cause relative movement between a second fluid conduit and a second valve element such that the second fluid conduit operably engages the second valve element to form a second fluid pathway through the connector.Clause A27. The method of clause A26, further comprising deactivating the first activation mechanism to cause relative movement between the first fluid conduit and the first valve element such that the first fluid conduit operably disengages the first valve element to block the first fluid pathway.Clause A28. The method of clause A26 or A27, further comprising deactivating the second activation mechanism to cause relative movement between the second fluid conduit and the second valve element such that the second fluid conduit operably disengages the second valve element to blockthe second fluid pathway.Clause A29. The method of any one of clauses A26 to A28, wherein the connector is an aseptic connector, and wherein the first fluid pathway is a first aseptic fluid pathway and wherein the second fluid pathway is a second aseptic fluid pathway.Clause A30. The method of any one of clauses A26 to A29, wherein the step of activating the first activation mechanism comprises piercing a first pierceable seal with a piercing member of the first fluid conduit, and wherein the step of activating the second activation mechanism comprises piercing a second pierceable seal with a piercing member of the second fluid conduit.Clause B1 . A connector, comprising:a housing extending between a distal end and a proximal end;a fluid conduit provided at least partially within the housing, a first end of the fluid conduit being fluidly connected to, or fluidly connectable to, a component, and a second end of the fluid conduit operably engageable with a valve element at one of the distal end and the proximal end of the housing, wherein the valve element is moveable with respect to the fluid conduit;an activation mechanism operable to cause relative movement between the fluid conduit and the valve element to enable the fluid conduit to operably engage the valve element, thereby providing a fluid flow path through the fluid conduit and the valve element; anda selection mechanism operably coupled to at least one of the fluid conduit and the valve element, and operable to move at least one of the fluid conduit and the valve element to coaxially align the second end of the fluid conduit with the valve element so as to permit the operable engagement between the fluid conduit and the valve element.Clause B2. A connector according to clause B1 , wherein the selection mechanism is operable to move at least one of the fluid conduit and the valve element between a first configuration in which the fluid conduit is coaxially aligned with the valve element, and a second configuration in which the fluid conduit is coaxially displaced from the valve element.Clause B3. A connector according to clause B1 or B2, wherein the valve element is a first valve element, and further comprising a second valve element at the same end of the housing as the first valve element, wherein the selection mechanism is operably coupled to the fluid conduit and / or the first and second valve elements, and operable to move the fluid conduit and / or the first and second valve elements between:a first configuration in which the fluid conduit is coaxially aligned with the first valve element, anda second configuration in which the fluid conduit is coaxially aligned with the second valve element.Clause B4. A connector according to any one of clauses B1 to B3, wherein each of the distal end and the proximal end of the housing comprises a valve element.Clause B5. A connector according to any one of clauses B1 to B4, wherein the valve element comprises a pierceable seal, and wherein the fluid conduit is a hollow needle.Clause B6. A connector according to clause B5, wherein the activation mechanism is operable to cause relative movement between the hollow needle and the pierceable seal to enable the hollow needle to pierce the pierceable seal and form the fluid flow path through the hollow needle and the pierceable seal.Clause B7. A connector according to clause B5 or B6, when dependent upon clause B4, wherein the hollow needle is a double-ended hollow needle.Clause B8. A connector according to clause B7, wherein:the activation mechanism is operable to cause relative movement between the first end of the double-ended hollow needle and one of the proximal end or the distal end of the housing to enable the first end of the double-ended hollow needle to pierce the pierceable seal of the valve element at said proximal end or distal end, andthe activation mechanism is further operable to cause relative movement between the second end of the double-ended hollow needle and the other of the proximal end or distal end of the housing to enable the second end of the double-ended hollow needle to pierce the pierceable seal of the valve element at said other of the proximal end or distal end.Clause B9. A connector according to clause B7, wherein the activation mechanism comprises:a first activation element operable to cause relative movement between the first end of the double-ended hollow needle and one of the proximal end or the distal end of the housing to enable the first end of the double-ended hollow needle to pierce the pierceable seal of the valve element at said proximal end or distal end, anda second activation element operable to cause relative movement between the second end of the double-ended hollow needle and the other of the proximal end or distal end of the housing to enable the second end of the double-ended hollow needle to pierce the pierceable seal of the valve element at said other of the proximal end or distal end.Clause B10. A connector according to clause B4, or any one of clauses B5 to B9 when dependent upon clause B4, wherein the selection mechanism is a first selection mechanism, and wherein the connector further comprises a second selection mechanism operably coupled to at least one of the fluid conduit and the valve element at the other of the proximal end or distal end, the second selection element operable to move at least one of the fluid conduit and the valve element to coaxially align the first end of the fluid conduit with the valve element so as to permit the operable engagement between the fluid conduit and the valve element.Clause B11. A connector according to any one of clauses B1 to B10, wherein the housing comprises a static portion and a selection portion moveably coupled to the static portion at one of the proximal end or the distal end of the housing, the selection portion comprising the valve element.Clause B12. A connector according to clause B11 , wherein the selection mechanism is operably coupled to the selection portion of the housing.Clause B13. A connector according to clause B11 or B12, wherein the selection portion is slidably coupled to the static portion.Clause B14. A connector according to any one of clauses B11 to B13, wherein the housing further comprises a flexible wall extending between the moveable portion and the static portion.Clause B15. A connector according to any one of clauses B11 to B14, wherein the selection portion comprises an internal volume, and wherein a collapsible sleeve extends between a first end and a second end, the first end connected to an outer surface of the fluid conduit and the second end connected to the internal volume of the selection portion.Clause B16. A connector according to any one of clauses B1 to B15, wherein the activation mechanism comprises an axially moveable collar coupled to the fluid conduit, wherein the collar is slidably mounted within the housing.Clause B17. A connector according to clause B16, wherein the collar comprises one or more protrusions engageable by an external actuator.Clause B18. A connector according to clause B16 or B17, wherein the activation mechanism further comprises an axially moveable connection element at one of the proximal end or the distal end of the housing, wherein the connection element is slidably mounted within the housing.Clause B19. A connector according to clause B18, wherein the connection element is configured to engage the collar when the connection element is actuated to slide within the housing.Clause B20. A connector according to clause B19, wherein the connection element comprises one or more protrusions engageable by an external actuator.Clause B21 . A connector according to any one of clauses B1 to B20, wherein the connector is an aseptic connector, and wherein the fluid pathway is an aseptic fluid pathway.Clause B22. A connector, comprising:a housing extending between a distal end and a proximal end, the distal end connected to, or connectable to, a component, and the proximal end comprising a first valve element and a second valve element;a fluid conduit provided at least partially within the housing, the first end of the fluid conduit being fluidly connected to, or fluidly connectable to, the component, and a second end of the fluid conduit operably engageable with the first valve element or the second valve element; andan activation mechanism operable to cause relative movement between the fluid conduit and the proximal end of the housing to enable the second end of fluid conduit to operably engage the first valve element or the second valve element, thereby providing a fluid flow path through the fluid conduit and the first valve element or second valve element; anda selection mechanism operably coupled to at least one of the proximal end of the housing, the first valve element, the second valve element, or the fluid conduit, and operable to move at least one of the proximal end of the housing, the first valve element, the second valveelement, or the fluid conduit between a first configuration in which the fluid conduit is coaxially aligned with the first valve element, and a second position in which the fluid conduit is coaxially aligned with the second valve element.Clause B23. A sterile package or a sterile container comprising the connector of any one of clauses B1 to B22.Clause B24. A kit of parts, comprising:a connector according to any one of clauses B1 to B22;a first component connectable to the distal end of the housing; anda second component connectable to the proximal end of the housing.Clause B25. The kit of parts of clause B24, further comprising a third component connectable to the proximal end of the housing.Clause B26. An apparatus, comprising:a connector according to any one of clauses B1 to B22;a first component connected to the distal end of the housing; anda second component connected to the proximal end of the housing.Clause B27. The apparatus of clause B26, further comprising a third component connected to the proximal end of the housing.Clause B28. The kit of parts of clause B24 or the apparatus of clause B26, wherein the first component and / or the second component comprises a container or interface coupled to a container.Clause B29. A system, comprising:a connector according to any one of clauses B1 to B22, or the apparatus of clause B26;an activation system configured to operably engage with the activation mechanism to cause relative movement between the fluid conduit and the valve element, anda selection system configured to operably engage with the selection mechanism to cause relative movement between the fluid conduit and the valve element.Clause B30. A method of forming a fluid pathway in a connector, comprising the steps of:activating a selection mechanism to cause relative movement between a first valve element at a first end of the connector and a fluid conduit to coaxially align the first valve element with the fluid conduit; andactivating an activation mechanism to cause relative movement between the fluid conduit and the first valve element such that the fluid conduit operably engages the first valve element to form a first fluid pathway through the connector.Clause B31 . The method according to clause B30, further comprising the step of:deactivating the activation mechanism to cause relative movement between the fluid conduit and the first valve element such that the fluid conduit operably disengages the first valve element to block the first fluid pathway.Clause B32. The method according to clause B31, further comprising the steps of:activating the selection mechanism to cause relative movement between a second valve element at the first end of the connector and the fluid conduit to coaxially align the second valve element with the fluid conduit;activating the activation mechanism to cause relative movement between the fluid conduit and the second valve element such that the fluid conduit operably engages the second valve element to forms a second fluid pathway through the connector; andoptionally deactivating the activation mechanism to cause relative movement between the fluid conduit and the second valve element such that the fluid conduit operably disengages the second valve element to block the second fluid pathway.LISTING OF DRAWING ELEMENTSconnector 138 second fluid conduithousing 140 third fluid conduitdistal end 142 fourth fluid conduitproximal end 144 piercing memberthreaded portion 146a first flexible tubefirst activation mechanism 146b second flexible tubefirst window 148 protrusionsecond activation mechanism 200 aseptic seal systemsecond window 202 clip portionthird activation mechanism 204 aseptic membranethird window 206 pair of substantially parallel lateral railsfourth activation mechanism208 upstanding wallfourth window210 openingcollar212 coupling protrusion first pierceable seal214 first sidesecond pierceable seal216 second sidethird pierceable seal218 foldfourth pierceable seal300 pierceable sealfirst fluid conduit302 bellows portion 610 proximal activation mechanism304 static portion612 proximal window306 first wall portion614 distal activation mechanism 308 second wall portion616 distal window310 inner return626 collar312 outer return628 pierceable seal314 closed end636 proximal fluid conduit 400 method638 distalfluid conduit 402 activating a first activationmechanism 644 piercing member404 deactivating the first 646 flexible tubeactivation mechanism648 protrusion406 activating a second activation700 activation system mechanism702 external actuator408 deactivating the secondactivation mechanism 800 connector600 connector 802 housing602 housing 804 distal end604 distal end 806 proximal end606 proximal end 808 connection element608 central longitudinal axis 810 static portionselection portion 840 collapsible sleeve portionflexible wall 842 static sleeve portionrounded surface 1000 methodrounded surface 1002 activating a selection mechanism to a first configuration hollow needle1004 activating an activation a first endmechanismb second end1006 deactivating the activation collar mechanismactivation mechanism 1008 activating the selection mechanism to a second first pierceable sealconfigurationsecond pierceable seal1010 activating the activation third pierceable seal mechanismproximal wall 1012 deactivating the activation mechanismside wall1014 activating the selection internal volumemechanism to a neutral first configurationcollapsible sleeve

Claims

CLAIMSWhat is claimed is:1 . A connector for selectively providing at least two fluid pathways therethrough, the connector comprising:a housing extending between a distal end and a proximal end;a first valve element and a second valve element at one end of the housing;at least one fluid conduit provided at least partially within the housing, a first end of the at least one fluid conduit being fluidly connected to, or fluidly connectable to, a component, and a second end of the at least one fluid conduit operably engageable with at least one of the first valve element and the second valve element to selectively provide a fluid flow path through the at least one conduit and the respective valve element; andat least one activation mechanism operable to selectively cause relative movement between the at least one fluid conduit and at least one of the first valve element and the second valve element to enable operable engagement therebetween.

2. The connector of claim 1, wherein each of the first valve element and the second valve element comprise a pierceable seal.

3. The connector of claim 2, wherein the proximal end comprises the first valve element and the second valve element, and the distal end of the housing comprises a third valve element.

4. The connector of claim 3, wherein the third valve element comprises a pierceable seal.

5. The connector of any one of claims 2 to 4, wherein the at least one fluid conduit comprises a piercing member, and wherein the piercing member faces the pierceable seal of the first valve element and / or the second valve element.

6. The connector according to claim 5, wherein the at least one activation mechanism is operable to cause relative movement between the piercing member and the pierceable seal of the first valve element and / or the second valve element to enable the piercing member to pierce the pierceable seal and form the fluid flow path through the at least one fluid conduit and the pierceable seal.

7. The connector of claim 5 or 6, wherein the at least one fluid conduit is a hollow needle.

8. The connector of claim 7, wherein the hollow needle is a double-ended hollow needle.

9. The connector according to claim 8, wherein:the at least one activation mechanism is operable to cause relative movement between the first end of the double-ended hollow needle and the proximal end of the housing to enable a first end of the double-ended hollow needle to pierce the pierceable seal of the first valve element and / or the second valve element, andthe at least one activation mechanism is operable to cause relative movement between a second end of the double-ended hollow needle and the distal end of the housing to enable the second end of the double-ended hollow needle to pierce the pierceable seal of the third valve element.

10. The connector according to any one of claims 1 to 9, further comprising a selection mechanism operably coupled to the at least one fluid conduit and / or the first and second valve elements, and operable to move the fluid conduit and / or the first and second valve elements between:a first configuration in which the at least one fluid conduit is coaxially aligned with the first valve element so as to permit the operable engagement between the at least one fluid conduit and the first valve element, anda second configuration in which the at least one fluid conduit is coaxially aligned with the second valve element so as to permit the operable engagement between the at least one fluid conduit and the second valve element.

11. The connector according to any one of claims 1 to 9, wherein the connector comprises:a first fluid conduit, wherein a first end of the first fluid conduit is fluidly connected to, or fluidly connectable to, a component, and a second end of the first fluid conduit operably engageable with the first valve element;a first activation mechanism operable to cause relative movement between the first fluid conduit and the first valve element to enable the first fluid conduit to operably engage the first valve element, thereby providing a first fluid flow path through the first fluid conduit and the first valve element;a second fluid conduit, wherein a first end of the second fluid conduit is fluidly connected to, or fluidly connectable to, a component, and a second end of the second fluid conduit operably engageable with the second valve element; anda second activation mechanism operable to cause relative movement between the second fluid conduit and the second valve element to enable the second fluid conduit to operably engage the second valve element thereby providing a second fluid flow path through the second fluid conduit and the second valve element,wherein the first activation mechanism and the second activation mechanism are independently operable.

12. The connector of any one of claims 1 to 11, wherein the first valve element and the second valve element are the same valve element.

13. The connector of any one of claims 1 to 11, wherein the first valve element and the second valve element are distinct valve elements.

14. The connector of any one of claims 1 to 13, wherein the connector is an aseptic connector for selectively forming two or more aseptic connections.

15. A kit of parts, comprising:a connector according to any one of claims 1 to 14;a first component connectable to the distal end of the housing; anda second component connectable to the proximal end of the housing.

16. An apparatus, comprising:a connector according to any one of claims 1 to 14;a first component connected to the distal end of the housing; anda second component connected to the proximal end of the housing.

17. A system, comprising:a connector according to any one of claims 1 to 14, or the apparatus of claim 16; and an activation system configured to operably engage with the at least one activation mechanism to cause relative movement between the at least one fluid conduit and the first valve element and / or the second valve element.

18. A method of transferring fluid through a connector, the method comprising:establishing a first fluid pathway between two ports of the connector to enable fluid communication through the connector;transferring a first fluid through the connector by way of the first fluid pathway;terminating the first fluid pathway to prevent fluid communication therethrough; establishing a second fluid pathway between two ports of the connector, the second fluid pathway being different from the first fluid pathway, to enable fluid communication through the connector;transferring a second fluid through the connector byway of the second fluid pathway.

19. The method of claim 18, wherein the step of establishing a first fluid pathway and / or the step of establishing a second fluid pathway comprise selectively configuring the connector to place the respective two ports in fluid communication.

20. The method of claim 18 or 19, wherein one or both of the two ports of the first fluid pathway and one or both of the two ports of the second fluid pathway are the same ports.

21. The method of claim 18 or 19, wherein the two ports of the first fluid pathway and the two ports of the second fluid pathway are distinct.

22. The method of any one of claims 18 to 21 , wherein the first fluid and the second fluid are the same fluid.

23. The method of any one of claims 18 to 21, wherein the first fluid and the second fluid are distinct fluids.

24. The method of any one of claims 18 to 23, further comprising terminating the second fluid pathway to prevent fluid communication therethrough.

25. The method of any one of claims 18 to 24, wherein the first fluid pathway and the second fluid pathway are fluidly isolated from one another.

26. The method of any one of claims 18 to 25, wherein the first fluid pathway and the second fluid pathway are independently establishable.

27. The method of any one of claims 18 to 26, wherein each of the two ports is a valve element.

28. The method of claim 27, wherein the first fluid pathway and / or the second fluid pathway is formed at least partly by a fluid conduit arranged to engage each valve element.

29. The method of claim 28, wherein each of the two ports comprises a pierceable seal, wherein the fluid conduit is a double-ended hollow needle, and wherein the step of establishing a firstfluid pathway and / or establishing a second fluid pathway comprises engaging each end of the hollow needle with the pierceable seal.

30. The method of any one of claims 18 to 29, wherein the first fluid pathway is a first aseptic fluid pathway, and the second fluid pathway is a second aseptic fluid pathway.

31. The method of any one of claims 18 to 30, wherein the steps are ordered.

32. The method of any one of claims 18 to 30, wherein two or more of the steps are concurrent.

33. The method of any one of claims 18 to 32, wherein the connector is the connector of any one of claims 1 to 17.

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