A connector

Abstract

There is provided a connector including a housing, a fluid conduit provided at least partially within the housing, an actuating mechanism configured 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 communication through the fluid conduit and the valve element, and a locking mechanism comprising at least one locking element pivotable so as to lock or unlock the actuating mechanism.

Description

A CONNECTORBACKGROUND

[0001] Biological processing techniques, particularly those used in the manufacture of cell and / or gene therapy products, are frequently complex and necessitate manual or semi-automated processes involving multiple devices. In particular, multiple devices, each serving different purposes or so-called unit operations, may be incorporated into cell and / or gene therapy manufacture systems and methodologies. The unit operations in such a methodology may include one or more of cell collection, isolation, selection, expansion, proliferation, washing, storing, and harvesting. However, the unit operations can vary significantly based on the manufacturing model (i.e. autologous or allogenic), the type of cell, the intended purpose, amongst other factors. As such, the current state of the art is inflexible and often cannot accommodate such a wide variety of methodologies and variables. Furthermore, cells are “living” entities, and are sensitive to even the most minor manipulations or changes in their environment, particularly during transfer between various devices.

[0002] The culture or processing of cells typically requires the use of a device to maintain the cells in an appropriate culture medium for proliferation and growth. Such known devices include shaker flasks, roller bottles, T-flasks, bags, bioreactors and the like. Subsequently, an addition or extraction step may be desirable to, or from, the device. For example, it may be desirable to provide an addition of culture medium, culture nutrients, cytokines, genetic modification agents, or like materials, in order to support the culture or processing methodology. Equally, it may be desirable to provide an extraction of exhausted culture medium, such as in a "washing" step, or to remove a sample directly from the device. There is also the need to accommodate for the transfer of materials between the multitude of devices utilized in a cell and / or gene therapy manufacture process, as stipulated above, each such transfer representing an opportunity to compromise sterility of the system, and hence the cell culture.

[0003] Therefore, there is a need for connecting one device to another device during biological processing methodologies, such as cell and / or gene therapy manufacture, in order to provide a communication, such as a fluid communication, between devices. Moreover, it is often desirable to provide a sterile, or an aseptic, connection between such devices, in addition to a sterile disconnection once the material transfer has been completed.

[0004] One solution is to provide a needle-based connector to enable communication through such a needle-based connector between two devices to be connected. However, one disadvantageof these needle-based connectors is the requirement to mitigate, or at least reduce, needle-stick injuries. These types of injuries are not only harmful to a user, whom may be exposed to harmful and / or toxic biological agents, but it also compromises the sterility of the connection and the contents of the devices to be connected.

[0005] Whilst attempts have been made to improve needle safety, for instance by providing locking mechanisms to prevent movement of the needle prior to an intentional actuation of the connector, there remains a problem that such locking mechanisms may become accidentally “unlocked” prior to the intended use. For instance, if a user accidentally drops such a connector, such locking mechanisms may become unintentionally “unlocked” through forces imparted onto the connector, and hence provides for the possibility of needle-stick injuries through unintentional actuation of the needle.

[0006] Therefore, a further object of the present invention is to enable a more reliable locking mechanism designed to mitigate, or at least reduce, needle-stick injuries.SUMMARY OF INVENTION

[0007] According to one aspect of the present invention, there is provided a connector, for introducing or extracting material to or from at least one receptacle, 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 connected or connectable to a first receptacle at the distal end, and a second end of the fluid conduit operably engageable with a valve element at the proximal end; an actuating mechanism configured 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 communication through the fluid conduit and the valve element; and a locking mechanism, comprising at least one locking element pivotable between a first configuration, in which the at least one locking element prevents the actuating mechanism from causing relative movement between the fluid conduit and the valve element, and a second configuration, in which the at least one locking element permits the actuating mechanism to cause relative movement between the fluid conduit and the valve element.

[0008] This provides the advantage that the fluid conduit only becomes connected to the valve element upon operation of the locking mechanism. That is, in the first configuration, the fluid conduit is prevented from operably engaging with the valve element, which is the lockedconfiguration. That is, in the second configuration, once the locking mechanism is operated by the user or a machine, the fluid conduit is permitted to operably engage with the valve element and form a communication therethrough. Thus, a communication is only formed upon an intentional actuation by the user or a machine.

[0009] Additionally, the provision of at least one locking element that is pivotable provides a locking mechanism that reliably maintains the first (i.e. locked) configuration prior to operation of such locking mechanism by the user or a machine. In particular, a pivotable locking element enables the locking element to withstand the forces experienced when dropping the connector, such that the locking mechanism does not unintentionally move to the second (i.e. unlocked) configuration prior to an intentional operation of such locking mechanism by the user or a machine. In particular, the pivotable nature of the locking element is advantageous in comparison to other locking elements, such as sliding clips.

[0010] In certain embodiments, the first end of the fluid conduit is operably engageable with a valve element at the distal end. That is, the valve element at the distal end may be regarded as a first valve element, and the valve element at the proximal end may be regarded as a second valve element, or vice versa.

[0011] In certain embodiments, the first end of the fluid conduit is operably engageable with the first valve element to enable a communication (e.g. fluid communication) with the first receptacle, and the second end of the fluid conduit is operably engageable with the second valve element to enable a communication (e.g. fluid communication) with the second receptacle.

[0012] In certain embodiments, the valve element (such as the first valve element and / or the second valve element) is formed as part of the connector, such as the housing. In some embodiments, the first valve element and the second valve element are formed as part of the connector.

[0013] In certain embodiments, the actuating mechanism is configured to cause relative movement between the fluid conduit and the second valve element to enable the fluid conduit to operably engage the second valve element, thereby providing a fluid communication through the fluid conduit and the second valve element.

[0014] In certain embodiments, the actuating mechanism is configured (or further configured) to cause relative movement between the fluid conduit and the first valve element to enable the fluid conduit to operably engage the first valve element, thereby providing a fluid communication through the fluid conduit and the first valve element.

[0015] In certain embodiments, the actuating mechanism is configured to cause relative movement between the fluid conduit and each of the first valve element and the second valve element to enable the fluid conduit to operably engage the first valve element and the second valve element, thereby providing a fluid communication through the first valve element, the fluid conduit, and the second valve element. In some embodiments, the actuating mechanism is configured to cause such relative movement in a sequential manner. For example, the actuating mechanism may be configured to cause relative movement between the fluid conduit and the second valve element, and then subsequently to cause relative movement between the fluid conduit and the first valve element. Equally, the actuating mechanism may be configured to cause relative movement between the fluid conduit and the first valve element, and then subsequently to cause relative movement between the fluid conduit and the second valve element

[0016] In certain embodiments, the fluid conduit is a hollow needle. The hollow needle may have a first end and a second end. Either the first end or the second end, or each of the first end and second end, may be a piercing end or an end configured to pierce a pierceable seal. The first end may be configured to pierce a pierceable seal at the distal end of the housing, such as a first pierceable seal. The second end may be configured to pierce a seal at the proximal end of the housing, such as a second pierceable seal.

[0017] In certain embodiments, the or each valve element is a valve. The or each valve may be a ball-valve, a check valve, a butterfly valve or the like. In such embodiments, the fluid conduit is moveable with respect to the or each valve so as to engage the or each valve between a closed configuration and an open configuration.

[0018] In certain embodiments, the or each valve element is a pierceable seal. In certain embodiments, the fluid conduit is a hollow needle and the or each valve element is a pierceable seal. In some embodiments, the fluid conduit is a hollow needle, and the valve element at the distal end (e.g. a first valve element) is a pierceable seal. In some embodiments, the fluid conduit is a hollow needle, and the valve element at the proximal end (e.g. a second valve element) is a pierceable seal. In some embodiments, the fluid conduit is a hollow needle, the first valve element is a first pierceable seal and the second valve element is a second pierceable.

[0019] In certain embodiments, the or each pierceable seal is a self-sealing seal. In certain embodiments, the or each pierceable seal is a septum seal, such as a self-sealing septum seal. In certain embodiments, the or each pierceable seal is, or forms, a hermetic seal. In certainembodiments, the housing comprises the or each pierceable seal. In certain embodiments, a portion of the actuating mechanism may comprise the or each pierceable seal.

[0020] A self-sealing seal or septum seal provides the advantage that sterility is maintained prior to, during, and after piercing of such a seal. A hermetic seal likewise enables sterility to be maintained.

[0021] In certain embodiments, the first end of the hollow needle is fluidly connectable to a first receptacle, and the actuating mechanism is operable to enable or cause the hollow needle to pierce a pierceable seal at the distal end of the housing (e.g. a first pierceable seal) to fluidly connect the first end of the hollow needle to the first receptacle.

[0022] In certain embodiments, the second end of the hollow needle is fluidly connectable to a second receptacle, and the actuating mechanism is operable to enable or cause the hollow needle to pierce the pierceable seal at the proximal end of the housing (e.g. a second pierceable seal) to fluidly connect the second end of the hollow needle to the second receptacle.

[0023] In certain embodiments, the first end of the hollow needle is fluidly connected or fluidly connectable to a first receptacle, and the actuating mechanism enables (or is operable to enable or cause) the hollow needle to pierce the pierceable seal (e.g. at the proximal end of the housing) to fluidly connect the second end of the hollow needle to a second receptacle.

[0024] This provides the advantage that the hollow needle only becomes connected to the pierceable seal when the actuating mechanism is engaged. The hollow needle cannot interact with the pierceable seal when it is in the first (i.e. locked) position. In the second (i.e. unlocked) position, the hollow needle is allowed to communicate with the pierceable seal and form a communication therethrough once the locking mechanism is operated by the user or a machine. As a result, using the needle-based connector may prevent, or at least lessen, needle-stick injuries.

[0025] In certain embodiments, the hollow needle is a double ended hollow needle. In some examples, the double ended hollow needle comprises a piercing end at each end. In some examples, one or both ends of the double ended hollow needle may be pointed and comprise an aperture in the side (i.e. shaft) of the needle to allow fluid flow. In other examples, one or both ends of the double ended hollow needle may be pointed and comprise an aperture at such end.

[0026] In certain embodiments, the hollow needle is a double ended hollow needle, and each of the proximal end and the distal end of the housing comprise a pierceable seal. That is, the distalend of the housing comprises a first pierceable seal, and the second end of the housing comprises a second pierceable seal.

[0027] In certain embodiments, the double ended hollow needle faces a pierceable seal at each of its ends (i.e. at a first end and a second end thereof).

[0028] This provides the advantage that the sterility of the connector and the communication pathway is maintained prior to use.

[0029] In certain embodiments, the actuating mechanism comprises at least a portion of the connector.

[0030] In certain embodiments, the actuating mechanism comprises at least a portion of the housing.

[0031] In certain embodiments, the housing comprises a collapsible sleeve assembly, wherein at least part of the collapsible sleeve assembly is collapsible between the proximal end and the distal end of the housing. As such, this may enable the hollow needle to pierce the or each pierceable seal, thereby forming a communication, such as a fluid communication, therethrough.

[0032] In certain embodiments, the collapsible sleeve assembly is collapsible between a collapsed configuration and a non-collapsed configuration. The collapsible sleeve assembly may be collapsible along an axis, such as a longitudinal axis, for example a central longitudinal axis of the connector. In certain embodiments, the collapsible sleeve assembly is collapsible along an axis that is parallel, or co-axial, to a pivot axis of the locking mechanism (i.e. an axis about which the locking mechanism pivots).

[0033] In certain embodiments, the collapsible sleeve assembly is biased towards the noncollapsed configuration by at least one biasing mechanism. That is, the collapsible sleeve assembly is biased into, and resists movement from, the non-collapsed configuration by the at least one biasing mechanism. The at least one biasing mechanism may act upon the collapsible sleeve assembly to urge or bias the collapsible sleeve assembly into or towards the non-collapsed configuration. The collapsible sleeve assembly may be operated from the non-collapsed configuration into the collapsed configuration upon application of a force that overcomes a predetermined threshold force imparted by the at least one biasing mechanism to the collapsible housing assembly.

[0034] This provides the advantage that unintentional actuation of the hollow needle is mitigated, for example during transit, as a force must be applies to overcome the predetermined forceimparted by the biasing mechanism to the collapsible sleeve assembly. As such, sterility of the connector is maintained prior to intended use.

[0035] In certain embodiments, the at least one biasing mechanism comprises a spring. For example, the at least one biasing mechanism comprises a helical spring.

[0036] In certain embodiments, the actuating mechanism comprises a collapsible housing, which at least a portion of which can be collapsed between the proximal and distal ends, thereby enabling the hollow needle to pierce the or each pierceable seal, thereby forming a communication, such as a fluid communication, therethrough. The collapsible housing may comprise the housing of the connector.

[0037] In certain embodiments, the collapsible housing comprises the valve element, such as a pierceable seal. In some embodiments, the collapsible housing comprises a first valve element at its distal end and a second valve element at its proximal end. In specific embodiments, the collapsible housing comprises a first pierceable seal at its distal end and a second pierceable seal at its proximal end.

[0038] In certain embodiments, the collapsible housing is collapsible such that the first valve element is moveable relative to the fluid conduit. In certain embodiments, the collapsible housing is collapsible such that the second valve element is moveable relative to the fluid conduit. In certain embodiments, the collapsible housing is collapsible such that each of the first valve element and the second valve element are moveable relative to the fluid conduit.

[0039] In certain embodiments, the collapsible sleeve assembly or collapsible housing comprises a moveable housing portion and a static housing portion, the moveable housing portion being axially moveable with respect to the static housing portion so as to collapse with respect thereto. The moveable housing portion may be axially moveable along a central axis, such as a central longitudinal axis of the connector, with respect to the static housing portion.

[0040] In certain embodiments, in the first configuration, the at least one locking element is operably engaged or engageable with a portion of the moveable housing portion to prevent axial movement of the moveable housing portion with respect to the static portion, and wherein, in the second configuration, the at least one locking element is operable disengaged from, or non- engageable with, the portion of the moveable housing portion to allow axial movement of the moveable housing portion with respect to the static portion.

[0041] Thus, in certain embodiments, the locking mechanism is operated between a first configuration, in which the locking mechanism prevents axial movement of the moveable housing portion, and a second configuration, in which the locking mechanism permits axial movement of the moveable housing portion.

[0042] In certain embodiments, the moveable housing portion comprises an engaging portion and the at least one locking element comprises a receiving portion, wherein the engaging portion of the moveable housing portion is operably engaged or engageable with the receiving portion of the at least one locking element in the first configuration, and wherein the engaging portion of the moveable housing portion is operably disengaged from, or non-engageable with, the receiving portion in the second configuration.

[0043] In certain embodiments, the moveable housing portion comprises an engaging portion and the at least one locking element comprises a receiving portion. In the first configuration, the receiving portion may be configured to receive the engaging portion to prevent relative movement between the moveable housing portion and the static housing portion. In the second configuration, the receiving portion may be configured to not receive (or be otherwise disengaged from) the engaging portion to allow relative movement between the moveable housing portion and the static housing portion.

[0044] Equally, in alternative embodiments, the moveable housing portion comprises the receiving portion and the at least one locking element comprises the engaging portion.

[0045] In certain embodiments, the engaging portion may comprise a projection, a lug, a hollow lug, a protrusion, a male member, or the like. In certain embodiments, the receiving portion may comprise a shelf, a shoulder, a window, a female member, or the like. In certain embodiments, the engaging portion and the receiving portion may be complementary, for example, complementary shapes and / or sizes.

[0046] In certain embodiments, the moveable housing portion comprises a projection and the at least one locking element comprises a shelf, wherein the projection of the moveable housing portion is engageable or engaged with the shelf in the first (i.e. locked) configuration, and wherein the projection of the moveable housing portion is non-engageable or disengaged from the shelf in the second (i.e. unlocked) configuration.

[0047] That is, the moveable housing portion comprises a projection, a lug, a hollow lug, a protrusion, a male member or the like that is engaged with, or is configured to engage with, a shelf, a shoulder, a window, a female member or the like in the first (i.e. locked) configuration. In thesecond (i.e. unlocked) configuration, the locking element is orientated such that the projection, lug or the like is disengaged from, or is configured to disengage from, the shelf, shoulder or the like.

[0048] In certain embodiments, the moveable housing portion comprises at least one actuatable element configured to be operable engaged by an activation system or activation apparatus. In certain embodiments, the at least one actuatable element comprises the engaging portion (such as the projection, the lug, the hollow lug, the protrusion, the male member or the like as discussed above). In certain embodiments, the moveable housing portion comprises a pair of actuatable elements, such as diametrically opposing actuatable elements.

[0049] In certain embodiments, the at least one actuatable element comprises an alignment feature. The alignment feature may prevent incorrect alignment between the at least one actuatable element and an activation system or activation apparatus that operably engages the at least one actuatable element during use.

[0050] In certain examples, the alignment feature may comprise a lead-in edge. The lead-in edge may be configured, shaped and / or located to direct a portion of the activation system or activation apparatus to the, or a portion of the, at least one actuatable element.

[0051] In certain embodiments, the alignment feature may comprise a longitudinally extending stem. In particular examples, the alignment features may comprise a longitudinally extending stem that extends in parallel to a longitudinal slot of the housing. Accordingly, the longitudinally extending stem may serve to block passage of a portion of the activation system or activation apparatus into the incorrect portion of the longitudinal slot of the housing.

[0052] In certain embodiments, each actuatable element may include an alignment feature or a plurality of alignment features.

[0053] In certain embodiments, the alignment feature is a locating feature. That is, the locating feature may operably engage a corresponding feature of the activation system or activation apparatus to ensure that the at least one actuatable element is correctly located with respect to the activation system or activation apparatus.

[0054] In certain embodiments, the static housing portion comprises the valve element, such as the pierceable seal. In some embodiments, the static housing portion comprises the valve element, such as the pierceable seal, at a proximal end thereof, which may be adjacent to, or corresponding with, the proximal end of the housing.

[0055] In certain embodiments, the moveable housing portion comprises the valve element, such as the pierceable seal. In some embodiments, the moveable housing portion comprises the valve element, such as the pierceable seal, at a distal end thereof, which may be adjacent to, or corresponding with, the distal end of the housing.

[0056] In certain embodiments, the moveable housing portion comprises a first valve element, such as a first pierceable seal. In some embodiments, the moveable housing portion comprises the first valve element, such as the first pierceable seal, at a distal end thereof, which may be adjacent to, or corresponding with, the distal end of the housing.

[0057] In certain embodiments, the static housing portion comprises a second valve element, such as a second pierceable seal. In some embodiments, the static housing portion comprises the second valve element, such as the second pierceable seal, at a proximal end thereof, which may be adjacent to, or corresponding with, the proximal end of the housing.

[0058] In certain embodiments, the actuating mechanism comprises a collar operably coupled or coupled to the fluid conduit (such as a hollow needle) and configured to be moved, or moveable, along an axis, such as a central longitudinal axis of the connector. As such, movement of the collar enables movement of the fluid conduit (such as a hollow needle), during use.

[0059] In certain embodiments, the fluid conduit (such as a hollow needle) may be coupled to the collar by virtue of an adhesive, a push-fit, a clip or the like.

[0060] In certain embodiments, in the first configuration, the at least one locking element is operably engaged or engageable with a portion of the collar to prevent axial movement of the collar, and wherein, in the second configuration, the at least one locking element is operable disengaged from, or non-engageable with, the portion of the collar to allow axial movement of the collar.

[0061] Thus, in certain embodiments, the locking mechanism is operated between a first configuration, in which the locking mechanism prevents axial movement of the collar, and a second configuration, in which the locking mechanism permits axial movement of the collar.

[0062] In certain embodiments, the collar comprises an engaging portion and the at least one locking element comprises a receiving portion, wherein the engaging portion of the collar is operably engaged or engageable with the receiving portion of the at least one locking element in the first configuration, and wherein the engaging portion of the collar is operably disengaged from, or non-engageable with, the receiving portion of the at least one locking element in the second configuration.

[0063] In certain embodiments, the collar comprises an engaging portion and the at least one locking element comprises a receiving portion. In the first configuration, the receiving portion may be configured to receive the engaging portion to prevent relative movement of the collar. In the second configuration, the receiving portion may be configured to not receive (or be otherwise disengaged from) the engaging portion to allow relative movement of the collar.

[0064] Equally, in alternative embodiments, the moveable housing portion comprises the receiving portion and the at least one locking element comprises the engaging portion.

[0065] In certain embodiments, the collar may comprise (as an engaging portion) a projection, a lug, a hollow lug, a protrusion, a male member, or the like. In certain embodiments, the receiving portion may comprise a shelf, a shoulder, a window, a female member, or the like. In certain embodiments, the engaging portion and the receiving portion may be complementary.

[0066] In certain embodiments, the collar comprises (as an engaging portion) a projection and the at least one locking element comprises a shelf, wherein the projection of the collar is engageable or engaged with the shelf in the first (i.e. locked) configuration, and wherein the projection of the collar is non-engageable or disengaged from the shelf in the second (i.e. unlocked) configuration.

[0067] That is, the collar comprises a projection, a lug, a hollow lug, a protrusion, a male member or the like that is engaged with, or is configured to engage with, a shelf, a shoulder, a window, a female member or the like in the first (i.e. locked) configuration. In the second (i.e. unlocked) configuration, the locking element is orientated such that the projection, lug or the like is disengaged from, or is configured to disengage from, the shelf, shoulder or the like.

[0068] In certain embodiments, the collar comprises at least one actuatable element configured to be operable engaged by an activation system or activation apparatus. In certain embodiments, the at least one actuatable element comprises the engaging portion (such as the projection, the lug, the hollow lug, the protrusion, the male member or the like as discussed above). In certain embodiments, the collar comprises a pair of actuatable elements, such as diametrically opposing actuatable elements.

[0069] In certain embodiments, the at least one actuatable element comprises an alignment feature. The alignment feature may prevent incorrect alignment between the at least one actuatable element and an activation system or activation apparatus that operably engages the at least one actuatable element during use.

[0070] In certain examples, the alignment feature may comprise a lead-in edge. The lead-in edge may be configured, shaped and / or located to direct a portion of the activation system or activation apparatus to the, or a portion of the, at least one actuatable element.

[0071] In certain embodiments, the alignment feature may comprise a longitudinally extending stem. In particular examples, the alignment features may comprise a longitudinally extending stem that extends in parallel to a longitudinal slot of the housing. Accordingly, the longitudinally extending stem may serve to block passage of a portion of the activation system or activation apparatus into the incorrect portion of the longitudinal slot of the housing.

[0072] In certain embodiments, each actuatable element may include an alignment feature or a plurality of alignment features.

[0073] In certain embodiments, the alignment feature is a locating feature. That is, the locating feature may operably engage a corresponding feature of the activation system or activation apparatus to ensure that the at least one actuatable element is correctly located with respect to the activation system or activation apparatus.

[0074] In certain embodiments, the at least one locking element is pivotable about an axis that is parallel to, or coaxial with, an axis substantially defined by the fluid conduit. That is, a pivot axis of the at least one locking element may be substantially parallel to, or coaxial with, an axis defined by the fluid conduit. In certain embodiments, each locking element comprises a pivot axis, and each such pivot axis may be substantially parallel to, or coaxial with, an axis defined by the fluid conduit. In specific embodiments, an axis defined by the fluid conduit is coaxial with a central longitudinal axis of the connector.

[0075] In certain embodiments, the at least one locking element comprises at least one pivotable arm.

[0076] In certain embodiments, the at least one locking element (such as the at least one pivotable arm) is pivotable about an axis that is parallel to a central longitudinal axis of the connector. Alternatively, the axis may be coaxial or perpendicular to the central longitudinal axis of the connector.

[0077] In certain embodiments, the at least one locking element comprises at least one pair of pivotable arms. The pair of pivotable arms may be an opposing pair, such as a diametrically opposing pair, of pivotable arms.

[0078] In certain embodiments, the at least one locking element comprises a first locking element (such as a first pivotable arm) and a second locking element (such as a second pivotable arm).

[0079] In some embodiments, the first locking element (such as a first pivotable arm) and the second locking element (such as a second pivotable arm) may be pivotable about the same axis or different axes.

[0080] In some embodiments, the first locking element comprises a first pair of pivotable arms. Each pivotable arm in the first pair of pivotable arms may be pivotable about an axis, such as a longitudinal axis, each axis being substantially parallel to one another.

[0081] In some embodiments, the second locking element comprises a second pair of pivotable arms. Each pivotable arm in the second pair of pivotable arms may be pivotable about an axis, such as a longitudinal axis, each axis being substantially parallel to one another.

[0082] In particular embodiments, a first arm in the first pair of pivotable arms and a first arm in the second pair of pivotable arms may be pivotable about a first axis, such as a first longitudinal axis. That is, each of the first arm of the first pair of pivotable arms and the first arm of the second pair of pivotable arms around pivotable about the same axis (i.e. the axes of each are co-axial). In particular embodiments, a second arm in the first pair of pivotable arms and a second arm in the second pair of pivotable arms may be pivotable about a second axis, such as a second longitudinal axis. That is, each of the second arm of the first pair of pivotable arms and the second arm of the second pair of pivotable arms around pivotable about the same axis (i.e. the axes of each are coaxial).

[0083] In particular embodiments, a first arm in the first pair of pivotable arms and a first arm in the second pair of pivotable arms each comprise an engagement surface. The engagement surface may be configured to receive a portion of an activation system or activation apparatus. Each engagement surface of the first arm in the first pair of pivotable arms and the first arm in the second pair of pivotable arms may be substantially coplanar.

[0084] In particular embodiments, a second arm in the first pair of pivotable arms and a second arm in the second pair of pivotable arms each comprise an engagement surface. The engagement surface may be configured to receive a portion of an activation system or activation apparatus. Each engagement surface of the second arm in the first pair of pivotable arms and the second arm in the second pair of pivotable arms may be substantially coplanar.

[0085] In certain embodiments, where the housing comprises a moveable housing portion and a static housing portion, the first locking element (such as a first pivotable arm) is pivotable between a first configuration, in which the first locking element (such as a first pivotable arm) is operably engaged with a portion of the moveable housing portion to prevent axial translation (or movement) of the moveable housing portion, and a second configuration, in which the first locking element (such as a first pivotable arm) is operably disengaged from the portion of the moveable housing portion to allow axial translation (or movement) of the moveable housing portion.

[0086] In certain embodiments, where the actuating mechanism comprises a collar coupled to the fluid conduit (such as the hollow needle), the second locking element (such as a second pivotable arm) is pivotable between a first configuration, in which the second locking element (such as a second pivotable arm) is operably engaged with a portion of the collar to prevent axial translation (or movement) of the collar (and hence the fluid conduit, such as the hollow needle), and a second configuration, in which the second locking element (such as a second pivotable arm) is operably disengaged from the portion of the collar to allow axial translation (or movement) of the collar (and hence the fluid conduit, such as the hollow needle).

[0087] In certain embodiments, the at least one locking element comprises a returning mechanism configured to return the at least one locking element into the first configuration. In specific embodiments, the returning mechanism comprises or is a biasing mechanism, for example a biasing means such as a spring, acting upon the at least one locking element.

[0088] In certain embodiments, the at least one locking element is biased into, or towards, the first configuration.

[0089] In certain embodiments, the at least one locking element is resiliently biased into, or towards, the first configuration.

[0090] In certain embodiments, the at least one locking element is resiliently biased by at least one spring. In particular embodiments, the at least one spring is operably coupled to each pivotable arm in a pair of pivotable arms.

[0091] This provides the advantage that the locking mechanism returns to its first (i.e. locked) configuration following actuation, without the need for locking mechanism to be reset via any mechanical interference.

[0092] In certain embodiments, the biasing mechanism comprises a retention element. The retention element may comprise a protrusion or a hook that operably engages and retains thebiasing means (e.g. the spring). The retention element may be formed on a pivotable arm of the pair of pivotable arms. There may be a plurality of retention elements. There may be a retention element provided on each pivotable arm in the pair of pivotable arms. For example, there may be a first retention element operably engaging and retaining a first end of the biasing means (e.g. the spring) and a second retention element operably engaging and retaining a second end of the biasing means (e.g. the spring).

[0093] In certain embodiments, the connector comprises a locating element. The locating element may comprise a protrusion or other like feature that is configured and / or located to locate or assemble the biasing means (e.g. the spring) to the or each retention element. In particular examples, there may be one or more such protrusions on each pivotable arm in the pair of pivotable arms.

[0094] In accordance with another aspect of the present invention, there is provided a method of connecting two receptacles, comprising the steps of: providing a connector as described herein; coupling a first receptacle to the distal end of the connector; coupling a second receptacle to the proximal end of the connector; operating the locking mechanism of the connector from the first configuration to the second configuration; and actuating the actuating mechanism to provide a fluid communication between the first receptacle and the second receptacle through the fluid conduit and the valve element.

[0095] In accordance with another aspect of the present invention, there is provided a system, comprising: a connector as described herein; and an activation apparatus configured to operably engage with the locking mechanism to enable operation of the locking mechanism between the first configuration and the second configuration.

[0096] In certain embodiments, the activation apparatus is further configured to actuate the actuating mechanism to enable the fluid conduit to engage the or each valve element and provide the fluid communication through the fluid conduit and the or each valve element.

[0097] In certain embodiments, the activation apparatus comprises at least one protrusion or prong that is configured to operably engage the locking mechanism to enable operation of the locking mechanism between the first configuration and the second configuration.

[0098] In certain embodiments, the at least one protrusion or prong of the activation apparatus is configured to operable engage at least one pivotable arm of the locking mechanism.

[0099] In certain embodiments, the at least one prong of the activation apparatus is further configured to actuate the actuatable element of the moveable housing portion and / or the collar. In certain embodiments, the at least one protrusion or prong of the activation apparatus is further configured to translate or move the moveable housing portion and / or the collar.

[0100] In certain embodiments, the activation apparatus includes a first protrusion or prong configured to engage a first pivotable arm of the locking mechanism acting upon the moveable housing portion, and a second protrusion or prong configured to operably engage a second pivotable arm of the locking mechanism acting upon the collar. In some embodiments, the first protrusion or prong may be further configured to actuate (e.g. translate or move) the moveable housing portion, and the second protrusion or prong may be further configured to actuate (e.g. translate or move) the collar. The first protrusion or prong may be provided as a pair of first protrusions or prongs to operable engage a pair of first pivotable arms. The second protrusion or prong may be provided as a pair of second protrusions or prongs to operable engage a pair of second pivotable arms.

[0101] In accordance with another aspect of the present invention, there is provided a sterile package or a sterile container comprising the connector as described herein.

[0102] In accordance with another aspect of the present invention, there is provided the connector as described herein comprising a container at an end thereof. For example, the container may be provided at a distal end or a proximal end thereof. In particular examples, the container may be provided coupled to the moveable housing potion. In any of the examples herein, the container may be a rigid container, a flexible container, a compressible container, a container comprising a bellows side wall (i.e. a side wall including Z-folds), a syringe, a syringe comprising a moveable plunger, a vacutainer or the like. The connector and the container herein may be regarded as a consumable, a dispensing apparatus, a sampling apparatus or the like.

[0103] In any of the aspects or embodiments noted herein, the connector is an aseptic, or sterile connector. In such cases, the communication, or fluid communication, is also aseptic or sterile.

[0104] It is noted that the terms “embodiments” and “aspects” are not intended to be limiting on various combination, and the person skilled in the art will recognize that the various “embodiments” discussed herein apply to any and all “aspects”.

[0105] As used herein, the term “aseptic” or “sterile” is used to describe a component, system, apparatus or method in which the passage of microbes is substantially, or entirely, prevented.

[0106] 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.

[0107] As used herein, the term “collapse” or “collapsible” is used to describe shortening in length or movement to shorten in length.

[0108] As used herein, the term “receptacle” is used to describe any vessel or container able to hold a material, such as a solid or a fluid. The term “receptacle” as used herein includes both rigid and flexible receptacles, including bags, bellows, bioreactors, flexible containers, rigid containers, vacutainers or the like.

[0109] As used herein, the term “double ended hollow needle” is used to describe a hollow needle that is pointed, or sharp, at both ends.

[0110] 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.

[0111] 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.

[0112] As used herein, the term “hermetic seal” is used to describe a fluid tight seal.

[0113] As used herein, the term “pierceable seal” is used to describe a seal that can be pierced, for example by a needle.

[0114] As used herein, the term “resealable pierceable seal” is used to describe a seal that is pierceable but also resealable in that, once the cause of the piercing is removed, such as a needle, the seal is able to reseal automatically.

[0115] As used herein, the term “to pierce” is used to describe the piercing of a material, such that the piercing element, such as a needle, at least partially protrudes through the material.

[0116] As used herein, the term “self-sealing”, 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.

[0117] 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.

[0118] Reference will now be made to the drawings, which depict one or more of embodiments described in this disclosure. However, it will be understood that other embodiments not depicted in the drawings will fall within the scope of this disclosure. Like numbers used in the figures refer to like components, steps and the like. However, it will be understood that the use of a number to refer to a component in a given figure is not intended to limit the component in another figure labelled with the same, or indeed a different, number. The figures are represented for the purpose of illustration and are not limiting. Schematic drawings presented in the figures are not necessarily to scale unless otherwise specified.BRIEF DESCRIPTION OF THE DRAWINGS

[0119] FIG. 1 illustrates a perspective view of a connector according to an embodiment;

[0120] FIG. 2 illustrates a detailed view of the actuating mechanism of the connector of FIG. 1 having the outer cover and the cap removed;

[0121] FIG. 3 illustrates a cross sectional view of the connector of FIG. 1 in a first configuration;

[0122] FIG. 4 illustrates a cross sectional view of the connector of FIG. 1 having the outer cover and cap removed, in a partially actuated configuration;

[0123] FIG. 5 illustrates a cross sectional view of the connector of FIG. 1 having the outer cover and cap removed, in a fully actuated configuration;

[0124] FIG. 6 illustrates a front view of the connector of FIG. 1 having the outer cover and cap removed; and

[0125] FIG. 7 illustrates (a) a cross sectional view of the connector of FIG. 1 having the outer cover and cap removed, and illustrating the upper pair of pivotable arms and (b) a cross sectional view of FIG. 1 having the outer cover and cap removed, and illustrating the lower pair of pivotable arms.

[0126] FIG. 8 illustrates a front view of an activation apparatus for use with the connector as described herein.DETAILED DESCRIPTION

[0127] The description example embodiments relate to a connector for introducing or extracting material to or from at least one receptacle. In particular, some embodiments relate to a connector that is an aseptic connector, or more particularly, a connector which maintains an aseptic environment during a material transfer. The terms “sterile” and “aseptic” are interchangeable. References to fluids in the detailed description are not intended to limit the scope of protection to such materials. As will be recognised by a person skilled in the art, fluids as described herein are merely an example of a suitable material for use with the described connector. Equally, reference may be made to a container, vacutainer or the like, however, such references in the detailed description are not intended to limit the scope of protection to such receptacles or vessels. As will be recognised by a person skilled in the art, containers, vacutainers or the like are described herein as mere examples of suitable receptacles.

[0128] Certain terminology is used in the following description for convenience only and is not limiting. The words ‘upper’ and ‘lower’ designate directions in the drawings to which reference is made and are with respect to the described component when assembled and mounted. The words ‘inner’, ‘inwardly' and ‘outer’, and ‘outwardly’ refer to directions toward and away from, respectively, a designated centreline or a geometric centre of an element being described (e.g. a 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 an axis or a point of attachment.

[0129] Further, as used herein, the terms ‘connected', ‘affixed’, ‘coupled’ and the like 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.

[0130] 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.

[0131] FIG. 1 illustrates a connector 100 including a housing 102 extending between a distal end 104 and a proximal end 106. The housing 102 includes an outer cover 108 having a flat rear wall 1 10 and a curved front wall 1 12. The flat rear wall 1 10 includes a pair of longitudinally extending slots 1 14 through which an activation apparatus (see FIG. 8) can access the actuating mechanism 1 16 of the connector 100 as described further below. The connector 100 also includes a cap 118 disposed at the proximal end 106 of the housing 102 for enclosing a base of the connector 100. The connector 100 also includes, as part of a moveable housing portion 120 (see FIG. 2), as described hereinafter, a container receiving portion 122 that is substantially cylindrical and includes an internally screw threaded portion 124. The container receiving portion 122 is also provided with anti-rotational threads 126 which are designed as a ratchet mechanism to interact with cooperating elements on a received container (not shown).

[0132] FIG. 2 and FIG. 3 illustrates a view of the actuating mechanism 1 16 and a locking mechanism 128 of the connector 100 of FIG. 1. As illustrated, the connector 100 includes a double ended hollow needle 130 that is operably coupled to a collar 132 as described below. The hollow needle 130 is operated by virtue of the actuating mechanism 1 16, in this embodiment composed of a collapsible sleeve arrangement, including a moveable housing portion 120 and a static housing portion (i.e. a portion 132 of the outer cover 108) as described further below.

[0133] The hollow needle 130 is disposed between a first self-sealing septum seal 138a towards the distal end 104 and a second self-sealing septum seal 138b towards the proximal end 106. The first self-sealing septum seal 138a is provided integrally as part of a compressible first gaiter 140 and is fixed, for example, by virtue of a friction-fit, adhesion or welding, to the moveable housing portion 120. The second self-sealing septum 138b is provided integrally as part of a compressible second gaiter 142 and is fixed, for example, by virtue of a friction-fit, adhesion or welding, to a portion of the outer cover 108. The first gaiter 140 and the second gaiter 142 house the hollow needle 130 therebetween, for example within a sterile volume, and ensure sterility of the hollow needle 130 prior to use.

[0134] The connector 100 is also provided with a sliding drawer 144, which is slidably coupled to the outer cover 108 and covered by the cap 1 18 during transit of the connector 100. The sliding drawer 144 is operably coupled, such as by virtue of an adhesive or by heat welding, to a polymeric membrane 146. The polymeric membrane 146 is disposed over the second septum seal 138b and is configured to be removed prior to actuation. In particular, the sliding drawer 144 may be operated from a first configuration (see FIG. 2) into a second configuration in which the polymeric membrane 146 is removed (e.g. pulled) from the second septum seal 138b so as toexpose the same. In this way, the polymeric membrane 146 forms an additional sterility barrier prior to use.

[0135] Referring to FIG.2 and FIG. 3, the actuating mechanism 1 16 is described as follows. There is provided a moveable housing portion 120 that includes a first pair of laterally extending hollow lugs 148, 150, and a collar 132 that includes a second pair of laterally extending hollow lugs 152, 154. The collar 132 is fixedly coupled to the hollow needle 130, for example, by virtue of a friction-fit, a push-fit, welding or adherence. Each hollow lug 148, 150 in the first pair of hollow lugs 148, 150 of the moveable housing portion 120, and each hollow lug 152, 154 in the second pair of hollow lugs 152, 154 of the collar 132 include an opening 156 that is configured and arranged to receive a protrusion of an activation apparatus (see FIG. 8) that enables unlocking of the locking mechanism 128 and axial movement of the moveable housing portion 120 and the collar 132, during use, as described further below. In some examples, although not illustrated, any one or more of the hollow lugs 148, 150, 152, 154 may include a longitudinally extending stem so as to “block” access above and / or below or the hollow lugs 148, 150, 152, 154 during use.Such longitudinally extending stem(s) may extend longitudinally and in parallel to the longitudinally extending slots 1 14 (see FIG. 1 ). This is particularly advantageous to ensure correct alignment with the hollow lugs 148, 150, 152, 154 as their openings 156 receive protrusions of an activation apparatus during use (see FIG. 8).

[0136] With further reference to FIG. 2 and FIG. 3, the actuating mechanism 1 16 also includes a biasing mechanism provided in the form of a helical spring 164, acting upon the moveable housing portion 120 and biasing the same into an unactuated position as shown in FIG. 3. In particular, the helical spring 164 is provided between the moveable housing portion 120 and the collar 132 to bias the moveable housing portion 120 away from the collar 132 and into the unactuated position, as shown in FIG. 3. In this way, the helical spring 164 provides a predetermined spring force that must be overcome by the activation apparatus in order to enable the hollow needle 130 to pierce the first self-sealing septum seal 138a, thereby mitigating accidental actuations of the connector 100 and hence needle-stick injuries. Whilst a helical spring 164 is depicted in this embodiment, the skilled person will appreciate that its inclusion is optional.

[0137] Referring further to FIG.2 and FIG. 3, the locking mechanism 128 is described as follows. The locking mechanism 128 includes a first pair of pivotable arms 166, 168 and a second pair of pivotable arms 170, 172. The a first pair of pivotable arms 166, 168 are provided adjacent the distal end 104 of the connector 100 and may be regarded as an upper pair of pivotable arms,whilst the second pair of pivotable arms 170, 172 are provided adjacent the proximal end 106 of the connector 100 and may be regarded as a lower pair of pivotable arms. Each arm 166, 168, 170, 172 is pivotable about an axis that is generally substantially perpendicular with a central longitudinal axis of the connector 100, as best shown in FIG. 2. In particular, a first pivotable arm 166 of the first pair of pivotable arms 166, 168 and a first pivotable arm 170 of the second pair of pivotable arms 170, 172 are pivotable about a first co-axial axis L1 . A second arm 168 of the first pair of pivotable arms 166, 168, and a second pivotable arm 172 of the second pair of pivotable arms 170, 172 are pivotable about a second co-axial axis L2.

[0138] Each arm 166, 168 in the first pair of pivotable arms 166, 168 includes a shelf 174 configured and arranged to receive at least a portion of the hollow lugs 148, 150 of the moveable housing portion 120 thereupon. As such, the shelf 174 of each arm 166, 168 is arranged so that each of the hollow lugs 148, 150 sit thereupon, or act as a stop, in the first (i.e. locked) configuration. The first pair of pivotable arms 166, 168 thereby act to resist axial movement of the hollow lugs 148, 150, and thus the moveable housing portion 120, during transit, thereby ensuring the hollow needle 130 does not pierce the first self-sealing septum seal 138a until desired. For completeness, it is noted as shown in FIG. 3, an upper end (i.e. an end adjacent the distal end 104) of the outer cover 108 provides a stop for the moveable housing portion 120. As such, a window is provided between the outer cover 108 and the shelves 174 in which the hollow lugs 148, 150 are received or otherwise provided in the first (i.e. locked) configuration.

[0139] Each arm 170, 172 in the second pair of pivotable arms 170, 172 includes a shelf 176 configured and arranged to receive at least a portion of the hollow lugs 152, 154 of the collar 132 thereupon. As such, the shelf 176 of each arm 170, 172 is arranged so that each of the hollow lugs 152, 154 sit thereupon, or act as a stop, in the first (i.e. locked) configuration. The second pair of pivotable arms 170, 172 thereby act to resist axial movement of the hollow lugs 152, 154, and thus the collar 132, during transit, thereby ensuring the hollow needle 130 does not pierce the second self-sealing septum seal 138b until desired. For completeness, it is noted, as shown in FIG. 3, that the shelf 176 of each of the second pair of pivotable arms 170, 172 provides a stop for the hollow lugs 152, 154 in a first direction, and that the shelf 174 of each of the first pair of pivotable arms 166, 168 provides a stop for the hollow lugs 152, 154 in a second direction. As such, the stops (i.e. abutting surfaces of the shelves 174, 176) together form a window between therebetween in which the hollow lugs 152, 154 are provided in the first (i.e. locked) configuration. 1

[0140] The operation of the actuating mechanism 1 16 and the locking mechanism 128 shall now be described with reference to FIG. 3 to FIG. 5. As noted above, FIG. 3 illustrates locking mechanism 128 of the connector 100 in its first (i.e. locked) configuration, with the hollow lugs 148, 150, 152, 154 engaging within their respective windows by virtue of respective shelves 174, 176, so as to prevent movement of the moveable housing portion 120 and the collar 132 (i.e. together the actuating mechanism 1 16), and hence preventing any relative movement between the hollow needle 130 and the septum seals 138a, 138b.

[0141] FIG. 4 illustrates the locking mechanism 128 of the connector 100 in its second (i.e. unlocked) configuration, where an activation apparatus (see FIG. 8) has engaged and acted upon each of the pivotable arms 166, 168, 170, 172, thereby pivoting the pivotable arms 166, 168, 170, 172 outwardly about their respective axes L1 , L2 (see FIG. 2) and hence out of the axial translation path of the hollow lugs 148, 150, 152, 154. In particular, the protrusions of the activation apparatus (see FIG. 8) pass through the hollow lugs 148, 150, 152, 154 and onto the respective lead-in edge 178 located on each arm 166, 168, 170, 172 (see FIG. 7) to cause them to pivot outwardly out of the path of the hollow lugs 148, 150, 152, 154, thereby allowing for axial translation of the moveable housing portion 120 and the collar 132. Once in the second (i.e. unlocked) configuration, the actuating mechanism 1 16 may be actuated, also by the activation apparatus (see FIG. 8), such that the hollow needle 130 pierces the second septum seal 138b, as illustrated in FIG. 4. In particular, the collar 132 is moved axially downwardly (i.e. towards the proximal end 106 shown in FIG. 2) such that the hollow needle 130 pierces through the second septum seal 138b.

[0142] FIG. 5 illustrates further actuation of the actuating mechanism 1 16. In particular, the moveable housing portion 120 is translated axially downwardly (i.e. towards the proximal end 106 shown in FIG. 2) such that the hollow needle 130 pierces the first septum seal 138a. The further actuation may be provided by the activation apparatus (see FIG. 8) in a similar manner to that in respect of the movement of the collar 132. In this way, the hollow needle 130 is caused to pierce through each of the first and second septum seals 138a, 138b, thereby providing communication through the hollow needle 130 of the connector 100. As such, although not shown, two receptacles may be fluidly connected, one at each of the distal end 104 and the proximal end 106 of the connector 100 (shown best in FIG. 2).

[0143] FIG. 6 illustrates a returning mechanism for the locking mechanism 128. In particular, the returning mechanism is provided in the form of a first coiled spring 180 and a second coiled spring 182. The first coiled spring 180 is operably connected to each arm 166, 168 in the first pairof pivotable arms 166, 168, and is configured to provide a bias to the first pair of pivotable arms 166, 168 towards one another and hence into the first (i.e. locked) configuration. In particular, the first coiled spring 180 is coupled to a protrusion 184 of each arm 166, 168. In this example, the protrusion 184 is provided as a hook. Although not illustrated, there may be a series of protrusions surrounding the hook so as to act as locating features for the first coiled spring 180. This also enables the first coiled spring 180 to be retained in position even if it were to become detached from the protrusion 184.

[0144] In this way, as the first pair of pivotable arms 166, 168 are pivoted outwardly with respect to one another, and forced apart, during use, the coiled spring 180 acts to return, i.e. pull, the first pair of pivotable arms 166, 168 back into their first (i.e. locked) configuration once the force imparted by the activation apparatus (see FIG. 8) is removed. This allows for the locking mechanism 128 to revert to the locked configuration following an actuation of the connector 100.

[0145] Similarly, the second coiled spring 182 is operably connected to each arm 170, 172 in the second pair of pivotable arms 170, 172 and is configured to provide a bias to the second pair of pivotable arms 170, 172 towards the first (i.e. locked) configuration. In particular, the second coiled spring 182 is coupled to a protrusion 186 of each arm 170, 172. In this example, the protrusion 186 is provided as a hook. As discussed above in respect of the first coiled spring 180, there may also be a series of protrusions surrounding the hook so as to act as locating features for the second coiled spring 182. This also enables the second coiled spring 182 to be retained in position even if it were to become detached from the protrusion 186.

[0146] In this way, as the second pair of pivotable arms 170, 172 are pivoted outwardly with respect to one another, and forced apart, during use, the second coiled spring 182 acts to return i.e. pull, the second pair of pivotable arms 170, 172 back into their first (i.e. locked) configuration once the force imparted by the activation apparatus is removed. This allows for the locking mechanism 128 to revert to the locked configuration following an actuation of the connector 100.

[0147] FIG. 7 and FIG. 8 are now referred to, in addition to FIG. 3, for illustrating the activation apparatus 200 and its interaction with the connector 100. In particular, the activation apparatus 200, shown in FIG. 8, includes a first moveable portion 201 including a first protrusion 202 and a second protrusion 204 forming a first pair of protrusions 202, 204. The activation apparatus 200 also includes a second moveable portion 205 including a first protrusion 206 and a second protrusion 208 forming a second pair of protrusions 206, 208. The first pair of protrusions 202, 204 interface with the moveable housing portion 120, namely the hollow lugs 148, 150 thereof(see FIG. 3). In particular, with reference also to FIG. 3, the first protrusion 202 is caused to pass through the hollow lug 148 and the second protrusion 204 is caused to pass through the hollow lug 150. In this way, the first pair of protrusions 202, 204 engage the lead-in edge 178 of the first pair of pivotable arms 166, 168 and disengage those pivotable arms 166, 168 from the hollow lugs 148, 150 of the moveable housing portion 120, enabling movement thereof.

[0148] Moreover, the second pair of protrusions 206, 208 interface with the collar 130, namely the hollow lugs 152, 154 thereof. In particular, the first protrusion 206 is caused to pass through the hollow lug 152 and the second protrusion 208 is caused to pass through the hollow lug 154. In this way, the second pair of protrusions 206, 208 engage the lead-in edge 178 of the second pair of pivotable arms 170, 172 and disengage those pivotable arms 170, 172 from the hollow lugs 152, 154 of the collar 132, enabling movement thereof.

[0149] Furthermore, the activation apparatus 200 also acts to actuate the actuating mechanism 1 16 as shown in FIG. 1 and FIG. 2. In particular, the first pair of protrusions 202, 204 act upon the moveable housing portion 120 and enable axial movement of the same. Moreover, the second pair of protrusions 206, 208 act upon the collar 132 and enable axial movement of the same. As such, the activation apparatus 200 enables both activation of the actuating mechanism 1 16 and the locking mechanism 128.

[0150] The activation apparatus 200 may be manually operated or may be semi-automated or fully automated. The activation apparatus 200 may include a user interface to enable a user to provide an input to the activation apparatus 200 to enable unlocking of the locking mechanism 128 and / or actuation of the actuating mechanism 1 16. The user may also select the order of piercing on the user interface.

[0151] Although the present embodiment is shown such that the second septum seal 138b is pierced prior to the first septum seal 138a, it will be appreciated by persons skilled in the art that the first septum seal 138a may be pierced prior to, or at the same time as, the second septum seal 138b.

[0152] It will be appreciate by persons skilled in the art that any manner of volumes may be coupled by virtue of the connector 100 described herein. By way of an example, although not shown, a first volume may include a container that incorporates a screw thread may be operably coupled (i.e. threadingly coupled) to the container receiving portion 122 (see FIG. 1 ). The container may be a receptacle, a vacutainer, a syringe or the like of any construction as desired by persons skilled in the art. By way of further example, although not shown, a second volumemay include a further container. The further container may comprise a container coupled to an interface. The container may be a bioreactor, and particularly may be a compressible container or bioreactor, such as that having Z-folds in its side wall. The interface may have a port. The port may be a septum seal, such as a self-sealing septum seal. During use, the second septum seal 138b may be arranged to abut the septum seal of the interface, and the hollow needle 130 may be caused to pierce both septum seal 126a of the connector 100 and also the septum seal of the interface, thereby providing a fluid communication to the second volume (e.g. further container).

[0153] As will be appreciated by persons skilled in the art, the components of the connectors, receptacles, interface place and the like may be composed of any suitable material. For example: the housing (such as the outer cover, the front curved wall, the rear flat wall, the cap, the moveable housing portion and the like) may be composed of polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS); the polymeric membrane composed of polyethylene (PE); the collar may be composed of polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS); the hollow needle may be composed of stainless steel or another appropriate biocompatible material or metal and may have any suitable gauge; the gaiters may be composed of low density polyethylene (LDPE), a thermoplastic elastomer (TPE), a silicon or the like; the first pierceable seal (i.e. of the moveable housing portion) may be composed of a thermoplastic elastomer, or a silicon and / or may be comoulded with the stationary sleeve portion; the moveable sleeve portion may be composed of polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS); the second pierceable seal (i.e. of the static housing portion) may be composed of a thermoplastic elastomer (TPE), or a silicon and / or may be co-moulded with the moveable sleeve portion; and the cap may be composed of polypropylene (PP), low density polyethylene (LDPE), or a combination thereof. 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.

[0154] 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, and that 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.

Claims

CLAIMS1 . A connector, for introducing or extracting material to or from a receptacle, 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 connected or connectable to a first receptacle at the distal end, and a second end of the fluid conduit operably engageable with a valve element at the proximal end; an actuating mechanism configured 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 communication through the fluid conduit and the valve element; and a locking mechanism, comprising at least one locking element pivotable between a first configuration, in which the at least one locking element prevents the actuating mechanism from causing relative movement between the fluid conduit and the valve element, and a second configuration, in which the at least one locking element permits the actuating mechanism to cause relative movement between the fluid conduit and the valve element.

2. A connector according to claim 1 , wherein the first end of the fluid conduit is operably engageable with a first valve element at the distal end, and wherein the valve element at the proximal end is a second valve element.

3. A connector according to claim 2, wherein the actuating mechanism is further configured to cause relative movement between the fluid conduit and the first valve element to enable the fluid conduit to operably engage the first valve element, thereby providing a fluid communication through the fluid conduit and the first valve element.

4. A connector according to any preceding claim, wherein the valve element is formed as part of the connector.

5. A connector according to any preceding claim, wherein the fluid conduit is a hollow needle.

6. A connector according to claim 5, wherein the valve element is a pierceable seal.

7. A connector according to claim 6, wherein the first end of the hollow needle is fluidly connected or fluidly connectable to a first receptacle at the distal end, and wherein the actuating mechanism enables the hollow needle to pierce the pierceable seal to fluidly connect the second end of the hollow needle to a second receptacle at the proximal end.

8. A connector according to any preceding claim, wherein the hollow needle is a double ended hollow needle, and wherein each of the proximal end and the distal end of the housing comprise a pierceable seal.

9. A connector according to any preceding claim, wherein the actuating mechanism comprises at least a portion of the housing.

10. A connector according to any preceding claim, wherein the housing comprises a collapsible sleeve assembly, wherein at least part of the collapsible sleeve assembly is collapsible between the proximal end and the distal end of the housing.11 . A connector according to claim 10, wherein the collapsible sleeve assembly is collapsible between a collapsed configuration and a non-collapsed configuration, and wherein the collapsible sleeve assembly is biased towards the non-collapsed configuration by at least one biasing mechanism.

12. A connector according to claim 1 1 , wherein the at least one biasing mechanism comprises a spring, such as a helical spring.

13. A connector according to any one of claims 10 to 12, wherein the collapsible sleeve assembly comprises a moveable housing portion and a static housing portion, the moveable housing portion being axially moveable along a central longitudinal axis with respect to the static housing portion so as to collapse with respect thereto.

14. A connector according to claim 13, wherein, in the first configuration, the at least one locking element is operably engaged or engageable with a portion of the moveable housing portion to prevent axial movement of the moveable housing portion with respect to the static portion, and wherein, in the second configuration, the at least one locking element is operable disengaged from, or non-engageable with, the portion of the moveable housing portion to allow axial movement of the moveable housing portion with respect to the static portion.

15. A connector according to claim 14, wherein the moveable housing portion comprises an engaging portion and the at least one locking element comprises a receiving portion, wherein the engaging portion of the moveable housing portion is operably engaged or engageable with the receiving portion of the at least one locking element in the first configuration, and wherein the engaging portion of the moveable housing portion is operably disengaged from, or non- engageable with, the receiving portion in the second configuration.

16. A connector according to claim 15, wherein the engaging portion of the moveable housing portion comprises a projection, a lug, a hollow lug, or a protrusion, and wherein the receiving portion of the at least one locking element comprises a shelf, a shoulder or a window.

17. A connector according to any preceding claim, wherein the actuating mechanism comprises a collar coupled to the fluid conduit and configured to be moved along the central longitudinal axis.

18. A connector according to claim 17, wherein, in the first configuration, the at least one locking element is operably engaged or engageable with a portion of the collar to prevent axial movement of the collar, and wherein, in the second configuration, the at least one locking element is operable disengaged from, or non-engageable with, the portion of the collar to allow axial movement of the collar.

19. A connector according to claim 18, wherein the collar comprises an engaging portion and the at least one locking element comprises a receiving portion, wherein the engaging portion of the collar is operably engaged or engageable with the receiving portion of the at least one locking element in the first configuration, and wherein the engaging portion of the collar is operably disengaged from, or non-engageable with, the receiving portion of the at least one locking element in the second configuration.

20. A connector according to claim 19, wherein the engaging portion of the collar comprises a projection, a lug, a hollow lug, or a protrusion, and wherein the receiving portion of the at least one locking element comprises a shelf, a shoulder or a window.21 . A connector according to any preceding claim, wherein the at least one locking element comprises at least one pivotable arm.

22. A connector according to claim 21 , wherein the at least one pivotable arm is pivotable about an axis that is parallel to a central longitudinal axis of the connector.

23. A connector according to claim 21 or 22, wherein the at least one locking element comprises at least one pair of pivotable arms.

24. A connector according to any preceding claim, wherein the at least one locking element is biased towards the first configuration.

25. A connector according to claim 24, wherein the at least one locking element is resiliently biased towards the first configuration.

26. A connector according to claim 25, wherein the at least one locking element is resiliently biased by at least one spring.

27. A method of connecting two receptacles, comprising the steps of: providing a connector in accordance with any preceding claim; coupling a first receptable to the distal end of the connector; coupling a second receptacle to the proximal end of the connector; operating the locking mechanism of the connector from the first configuration to the second configuration; and actuating the actuating mechanism to provide a fluid communication between the first receptacle and the second receptacle through the fluid conduit and the valve element.

28. A system, comprising: a connector in accordance with any one of claims 1 to 26; an activation apparatus configured to operably engage with the locking mechanism to enable operation of the locking mechanism between the first configuration and the second configuration.

29. The system of claim 28, wherein the activation apparatus is further configured to actuate the actuating mechanism to enable the fluid conduit to engage the valve element and provide the fluid communication through the fluid conduit and the valve element.

30. A sterile package or a sterile container comprising the connector according to any one of claims 1 to 26.

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