Connector

Abstract

To provide a connector for introducing material into or extracting material from at least one receptacle.SOLUTION: The connector of the present invention includes: a housing extending between a distal end and a proximal end and including a pierceable seal at least one end; a hollow needle mounted at least partially within the housing between the distal end and the proximal end of the housing, a first end of the hollow needle being connected or connectable to a first corresponding receptacle, and a second end of the hollow needle facing the pierceable seal at the end of the housing; and an actuation mechanism acting on the housing or the hollow needle to enable the hollow needle to pierce the pierceable seal, thereby forming communication through the pierceable seal and allowing material to be transferred through the connector.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to connectors, e.g., sterile connectors. More specifically, the present invention relates to connectors for introducing material into or extracting material from at least one receptacle. The connectors described herein can form part of a cell and / or gene therapy manufacturing device or process. [Background technology]

[0002] Cell and gene therapy manufacturing processes are often complex, involving manual or semi-automated steps across several devices. The equipment systems used in various steps (or unit operations) of cell-based therapeutic product (CTP) manufacturing can include devices for various functions. These various functions can be, for example, cell collection, cell isolation, cell selection, cell expansion, cell washing, volume reduction, cell storage, or transport. Unit operations can vary greatly based on the manufacturing model (i.e., autologous versus allogeneic), cell type, and intended purpose, among other factors. Additionally, cells are "living" entities that are sensitive to even the simplest manipulations (e.g., differences in cell transfer procedures). The role of cell manufacturing equipment in ensuring scalability and reproducibility is a critical factor for cell and gene therapy manufacturing.

[0003] Additionally, cell-based therapeutic products (CTPs) are experiencing a significant expansion, and therefore, there is a need for improved cell manufacturing equipment for various cell manufacturing procedures, which may include, for example, stem cell enrichment, chimeric antigen receptor (CAR) T-cell generation, and various cell manufacturing processes (e.g., collection, purification, genetic modification, culture, harvesting, washing, infusion into patients, or freezing).

[0004] Cell cultivation or processing typically requires the use of a device to hold the cells in, for example, a suitable culture medium as they are cultured. Known devices include shaker flasks, roller bottles, T-flasks, bags, etc. Such devices are typically required to be connected to other devices (e.g., containers or interfaces) so that various media can be introduced into (or removed from) the cell-holding device.

[0005] As such, a need exists for connecting one device to another and enabling fluid communication between the devices during the cell and gene therapy manufacturing process. Moreover, it is often desirable to provide sterile (or aseptic) connections between various devices so that sterile (or aseptic) fluid connections can be achieved. However, known connectors suffer from several drawbacks.

[0006] In some known connectors (particularly sterile connectors), a first device or container having a first volume of fluid can be connected to a second device or container having a second volume of fluid through a genderless connector, a male-female connector, a threaded connector, or the like. Typically, a first portion of the connector is connected to the first device, and a second portion of the connector is connected to the second device. The first and second portions of the connector each include opposing removable adhesive strips that face each other, providing sterilely sealed ends for the first and second devices. During use, a connection is made between the first and second portions of the connector, and the opposing adhesive strips adhere to each other. The user then removes the adhesive strip, thus removing the attached sterile strip from the connection. In this way, a sterile fluid pathway is provided between the first and second devices.

[0007] However, such sterile connectors have many drawbacks. The primary disadvantage of such sterile connectors is that the first and second devices or containers cannot be disconnected and / or reconnected aseptically. Instead, a non-sterile environment is created when the first and second portions of the connector are disconnected. Therefore, it is necessary to dispose of such connectors or to sterilize them, both of which are costly for the user. Moreover, the adhesive strips in such sterile connectors are unsuitable for use in applications where they may come into contact with liquids or are subject to pressure (i.e., pressures greater than atmospheric pressure). Moreover, such adhesive strips are unsuitable for automated processes and require tedious assembly on the part of the user. Summary of the Invention [Problem to be solved by the invention]

[0008] SUMMARY OF THE INVENTION It is therefore an object of the present invention to address some of the disadvantages associated with known connectors, particularly sterile connectors. [Means for solving the problem]

[0009] According to one aspect of the present invention, there is provided a connector for introducing material into or extracting material from at least one receptacle, the connector comprising: - a housing extending between a distal end and a proximal end, the housing including a pierceable seal at at least one end; - a hollow needle mounted at least partially within the housing between a distal end and a proximal end of the housing, a first end of the hollow needle being connected or connectable to a first receptacle and a second end of the hollow needle facing a pierceable seal at an end of the housing; an actuation mechanism acting on the housing or hollow needle to enable the hollow needle to pierce the pierceable seal, thereby creating communication through the pierceable seal and allowing material to be transferred through the connector; A connector is provided, including:

[0010] Suitably, in some embodiments, the connector includes a housing extending longitudinally between a distal end and a proximal end.

[0011] In some embodiments, the distal end of the connector housing includes a pierceable seal. In some embodiments, the proximal end of the connector housing includes a pierceable seal. In certain embodiments, both the distal end of the connector housing and the proximal end of the housing include pierceable seals.

[0012] In some embodiments, the first end of the hollow needle may be connected to a first receptacle. In some embodiments, the first end of the hollow needle may be connectable to a first receptacle.

[0013] In some embodiments, the first end of the hollow needle is in communication with or is capable of communicating with the first receptacle.

[0014] In some embodiments, the first receptacle contains the material. The first receptacle can be any vessel capable of holding the material.

[0015] The material can be a solid. The material can be a fluid. The material can be a gas.

[0016] In some embodiments, the first end of the hollow needle may be pre-connected to the first receptacle, for example, the connector may be part of the receptacle.

[0017] In some embodiments, the hollow needle is in direct communication with the first receptacle.

[0018] In another aspect of the present invention, there is provided a receptacle comprising a connector as described herein. In some embodiments, the connector can be part of a bioreactor.

[0019] In some embodiments, the connector may be constructed and arranged to be connected to the first receptacle.

[0020] In suitable configurations, the hollow needle is configured to protrude (or pierce) through the pierceable seal. For example, the hollow needle can be sharpened at one or both ends. In some embodiments, the hollow needle includes a sharpened end. In certain embodiments, the hollow needle is sharpened at both ends. In certain embodiments, the hollow needle is double-ended. In certain embodiments, the first end or the second end includes a pencil-point closed end and a port adjacent to the pencil-point closed end (i.e., a Whitacre end). That is, the port can provide for the entry and / or exit of fluids into and / or from the hollow bore of the hollow needle. In certain embodiments, the first end or the second end includes an open end. In certain embodiments, the open end includes a beveled open end or a chamfered open end. That is, the open end (e.g., a beveled open end or a chamfered open end) can provide for the entry and / or exit of fluids into and / or from the hollow bore of the hollow needle.

[0021] In certain embodiments, a longitudinally extending slot is provided in the hollow needle, extending from the open end toward the opposing end (e.g., toward the collar), which provides the advantage that evacuation of fluid (e.g., liquid or material) from a fluidly connected receptacle is aided by the longitudinally extending slot.

[0022] In certain embodiments, the hollow needle is an 18 gauge (18G) needle. In other embodiments, the hollow needle is a 14 gauge (14G), 15 gauge (15G), 20 gauge (20G), 21 gauge (21G), 22 gauge (22G), 23 gauge (23G), 25 gauge (25G), or 27 gauge (G) needle. Preferably, the hollow needle comprises stainless steel.

[0023] For ease of describing the invention herein, the distal end of the connector refers to the upper (first) end of the connector, distal to the second receptacle. For ease of describing the invention herein, the proximal end of the connector refers to the lower (second) end of the connector, proximal to the second receptacle. These terms used to describe the ends of the connector housing or other parts of the connector are not meant to be limiting, but are merely to aid in describing the invention.

[0024] Advantageously, the present invention provides a connector that is easy to use to connect a first receptacle with a second receptacle. Advantageously, this can be for connecting a first receptacle (e.g., containing a fluid or a solid) with a second receptacle (e.g., containing a fluid or a solid). Further advantageously, the present invention provides a connector that is suitable for automation, for example, for use in automated cell therapy and / or gene therapy manufacturing processes.

[0025] Advantageously, the connector allows for easy communication between one or more receptacles for introducing or extracting a material. The introduction or extraction of a material can be in either manner through the connector. For example, the connector can allow for easy introduction of a material into a receptacle, or it can allow for easy extraction of a material from a receptacle.

[0026] As will be apparent to one skilled in the art, the present invention applies to the introduction or extraction of any suitable material (e.g., fluid or solid). Fluids generally include liquids and gases, but can also include solutions, suspensions, gels, pastes, etc. Solids can be granular (e.g., powders). In some embodiments, the volume of fluid in the first receptacle or the second receptacle contains one or more solids or one or more fluids. In some embodiments, the one or more solids can be suspended in the fluid (e.g., liquid). In some examples, the solid can include one or more magnetic beads for use in cell culturing or processing. The one or more magnetic beads may or may not be suspended in the fluid (e.g., liquid).

[0027] The material may include a magnetic bead.The material may include a plurality of magnetic beads.

[0028] The connector of the present invention provides the advantage that a first receptacle can be connected, disconnected, and reconnected to a second receptacle by the connector. More specifically, the connection, disconnection, and reconnection can be accomplished in an aseptic (or sterile) manner. Moreover, the connector can be more suitable for automated processes and can be easier to handle and use.

[0029] In some embodiments, the actuation mechanism can include a hollow needle being bias mounted.

[0030] In some embodiments, the hollow needle is biased to load. In certain embodiments, the hollow needle is biased to load at least partially within the connector housing. In certain embodiments, the hollow needle is biased to load at least partially within the housing, with the longitudinal length of the needle extending at least partially between the proximal and distal ends of the connector housing. The hollow needle may be biased to load by any means. In some embodiments, there is one biasing mechanism for providing a first biasing force. This first biasing force may be to bias the hollow needle to load. In certain embodiments, there are two biasing mechanisms for biasing the hollow needle to load. In embodiments where there are two biasing mechanisms, the second biasing mechanism may provide a second biasing force. This second biasing force may be on the hollow needle. In some embodiments, the connector includes a spring for biasing the hollow needle to load. In certain embodiments, the connector includes two springs for biasing the hollow needle to load. The hollow needle may be mounted with a bias in one direction or two directions. In some embodiments, the first biasing mechanism includes a spring. In some embodiments, the second biasing mechanism includes a spring. In certain embodiments, both the first biasing mechanism and the second biasing mechanism include a spring. In more specific embodiments, the or each spring may be a helical spring.

[0031] In some embodiments, the actuation mechanism includes a collar. In some embodiments, the actuation mechanism includes a rail. In some embodiments, the actuation mechanism includes both a collar and a rail. In some embodiments, the collar is with the connector housing. In some embodiments, the rail is with the housing. In some embodiments, the collar is configured to be able to move along the length of the rail. In some embodiments, the collar includes one or more protrusions configured to engage with the rail.

[0032] In some embodiments, the bias-loaded needle is held within the connector housing by a collar, which may be considered a needle holder.

[0033] In certain embodiments, the connector further includes an actuation mechanism that allows the hollow needle to pierce the pierceable seal and connect to the second receptacle.

[0034] In certain embodiments, the connector further includes an actuation mechanism that allows the hollow needle to pierce the pierceable seal.

[0035] In certain embodiments, the connector further includes an actuation mechanism that allows the hollow needle to pierce the pierceable seal, thereby creating communication through the pierceable seal.

[0036] In certain embodiments, the connector further includes an actuation mechanism that allows the hollow needle to pierce the pierceable seal, thereby creating communication through the pierceable seal and allowing material to be transferred through the connector.

[0037] This provides the advantage that the connector can be actuated manually or by an automated system without the risk of needlestick injury, and in certain embodiments, this can advantageously allow for the connection of two receptacles in a sterile manner.

[0038] The actuation mechanism can include folding (or partially folding) the housing. In some embodiments, the actuation mechanism includes a foldable housing.

[0039] Advantageously, this is a simple mechanism for achieving connection of two receptacles in an easy-to-use manner. A foldable housing for a connector can be cheap and simple to manufacture. Advantageously, a connector with a foldable housing can be disposable.

[0040] In certain embodiments, the actuation mechanism moves the hollow needle, allowing the hollow needle to pierce the pierceable seal and connect to the second receptacle.

[0041] In certain embodiments, the actuation mechanism moves the hollow needle, enabling the hollow needle to pierce the pierceable seal. In certain embodiments, the actuation mechanism moves the hollow needle, enabling the hollow needle to pierce the pierceable seal and enable communication with the second receptacle. In certain embodiments, the actuation mechanism moves the hollow needle, enabling the hollow needle to pierce the pierceable seal, thereby forming communication through the pierceable seal and enabling communication with the second receptacle.

[0042] In some embodiments, the actuation mechanism enables axial translation of the hollow needle. The axial translation of the hollow needle can enable the hollow needle to pierce the pierceable seal. In some embodiments, the actuation mechanism enables axial translation of the hollow needle to pierce the pierceable seal at the proximal end of the connector housing. In some embodiments, the actuation mechanism enables axial translation of the hollow needle to pierce the pierceable seal at the distal end of the connector housing. In some embodiments, the actuation mechanism enables axial translation of the pierceable seal at the proximal end of the connector housing to contact the hollow needle and pierce the pierceable seal at the proximal end of the connector housing. In some embodiments, the actuation mechanism enables axial translation of the pierceable seal at the distal end of the connector housing to contact the hollow needle and pierce the pierceable seal at the distal end of the connector housing.

[0043] In some embodiments, piercing the pierceable seal thereby creates communication through the pierceable seal.

[0044] In some embodiments, piercing the pierceable seal thereby creates communication through the pierceable seal, allowing material to be transferred through the connector.

[0045] In certain embodiments, the actuation mechanism allows a hollow needle to pierce pierceable seals at both the proximal and distal ends of the connector housing.

[0046] In certain embodiments, where the actuation mechanism allows the hollow needle to pierce pierceable seals at both the proximal and distal ends of the connector housing, this may be by, for example, axial translation of the hollow needle and axial translation of one of the pierceable seals.

[0047] In certain embodiments, the actuation mechanism moves the housing or a portion of the housing, allowing the hollow needle to pierce the pierceable seal and connect to the second receptacle.

[0048] In certain embodiments, the actuation mechanism moves the housing or a portion of the housing, allowing the hollow needle to pierce the pierceable seal and communicate with the second receptacle.

[0049] In certain embodiments, the housing is foldable between the proximal and distal ends to allow a hollow needle to pierce the pierceable seal and connect to the second receptacle.

[0050] In certain embodiments, the housing is foldable between the proximal and distal ends to allow the hollow needle to pierce the pierceable seal and communicate with the second receptacle.

[0051] In certain embodiments, the actuation mechanism includes an outer sleeve configured to allow the hollow needle to pierce the pierceable seal and connect to the second receptacle.

[0052] In certain embodiments, the actuation mechanism includes an outer sleeve configured to allow the hollow needle to pierce the pierceable seal and communicate with the second receptacle.

[0053] In certain embodiments, the outer sleeve is configured such that at least partial rotation of the outer sleeve causes axial translation of the hollow needle to pierce the pierceable seal and connect to the second receptacle.

[0054] In certain embodiments, the outer sleeve is configured such that at least partial rotation of the outer sleeve causes axial translation of the hollow needle to pierce the pierceable seal and communicate with the second receptacle.

[0055] This provides the advantage that the connector can be manually actuated without the risk of needle stick injury.

[0056] In some embodiments, a first end of the hollow needle is connected or connectable to a first receptacle, and an actuation mechanism enables the hollow needle to pierce the pierceable seal and connects a second end of the hollow needle to a second receptacle.

[0057] In some embodiments, a first end of the hollow needle is connected or connectable to a first receptacle, and an actuation mechanism enables the hollow needle to pierce the pierceable seal and enables a second end of the hollow needle to communicate with a second receptacle.

[0058] In some embodiments, the actuation mechanism may be configured such that it is operable only when the connector is engaged with both the first receptacle and the second receptacle, i.e., in some embodiments, the actuation mechanism may be operable only when the first receptacle is connected to the distal end of the housing and when the second receptacle is connected to the proximal end of the housing.

[0059] In some embodiments, the actuation mechanism may include one or more engagement portions configured to engage with corresponding portions of the receptacle such that the actuation mechanism is operable when the or each engagement portion engages with the corresponding portion.

[0060] This provides the advantage that needle stick injuries are avoided as the hollow needles can only be activated when connected to the respective first and second receptacles.

[0061] In certain embodiments, the outer sleeve is configured such that the outer sleeve causes a releasable locking engagement between a proximal end of the outer sleeve and a portion of a corresponding receptacle (e.g., a second receptacle) of the connector.

[0062] This provides the advantage that a user can easily identify, either tactilely, visually, or tactile-visually, that a connector is properly connected to a corresponding receptacle.

[0063] In some embodiments, the connectors of the present invention can be releasably attached to one or more receptacles. In some embodiments, the connectors can be releasably attached to one or more receptacles in a fluid-tight manner. In some embodiments, the connectors can be releasably attached to one or more receptacles in a sterile, tight manner.

[0064] In certain embodiments, the foldable housing includes an upper housing portion and a lower housing portion, and the upper housing portion is axially movable along a central longitudinal axis relative to the lower housing portion. Thus, the upper housing portion can be foldable relative to the lower housing portion. In some instances, folding the upper housing portion relative to the lower housing portion causes the hollow needle to pierce a pierceable hermetic seal of the upper housing portion.

[0065] In some embodiments, the first portion of the foldable housing may be axially movable (or translatable) relative to the second portion of the foldable housing along a central axis extending between the distal and proximal ends of the connector. Thus, a movable portion of the housing and a stationary portion of the housing may be provided.

[0066] In certain embodiments, the outer sleeve may provide folding (or actuation) of the upper housing portion relative to the lower housing portion, and thus the outer sleeve may be considered to form part of the actuation mechanism.

[0067] Alternatively, in certain embodiments, the foldable housing includes an upper housing portion and a lower housing portion, the lower housing portion being axially movable along the central longitudinal axis relative to the upper housing portion. Thus, the lower housing portion may be foldable relative to the upper housing portion. In some instances, folding the lower housing portion relative to the upper housing portion causes the hollow needle to pierce the pierceable hermetic seal of the lower housing portion.

[0068] Further alternatively, in certain embodiments, the foldable housing includes an upper housing portion and a lower housing portion, the lower housing portion being axially movable along a central longitudinal axis relative to the upper housing portion, and the upper housing portion being axially movable along the central longitudinal axis relative to the lower housing portion. Thus, each of the lower and upper housing portions may be foldable relative to one another. In some examples, folding the lower housing portion relative to the upper housing portion and folding the upper housing portion relative to the lower housing portion causes the hollow needle to pierce the pierceable hermetic seal of the upper housing portion and the pierceable hermetic seal of the lower housing portion. The sequential piercing of the seals may be controlled by the folding order.

[0069] In certain embodiments, the upper housing portion includes at least one actuatable lug configured to move the upper housing portion along the central longitudinal axis, and the at least one actuatable lug of the upper housing portion protrudes at least partially (or mostly or completely) through at least one slot of the outer sleeve. That is, in some embodiments, the outer sleeve further includes at least one slot, and the actuatable lug of the upper housing protrudes (at least partially through) the at least one slot.

[0070] This provides the advantage that the connector is suitable for automated operation, and therefore the connector is advantageously suitable for automated cell therapy and / or gene therapy manufacturing processes.

[0071] In some embodiments, the upper housing portion includes a plurality of actuatable lugs. In some embodiments, the outer sleeve includes a plurality of slots. In certain embodiments, each actuatable lug protrudes at least partially (or mostly or completely) through one of the plurality of slots.

[0072] In some embodiments, the upper housing portion includes a pair of diametrically opposed actuatable lugs. In some embodiments, the outer sleeve includes a pair of diametrically opposed slots. In certain embodiments, each actuatable lug protrudes at least partially through one of the pair of slots.

[0073] In some embodiments, the actuatable lug on the upper housing portion has a circular or cruciform (ie, cross-shaped) cross-section.

[0074] In some embodiments, the upper housing portion includes at least one rib. In some embodiments, the upper housing portion includes a pair of ribs. In some embodiments, the upper housing portion includes a pair of ribs, each rib disposed on either side of the actuatable lug of the upper housing portion. In certain embodiments, the or each rib of the upper housing portion may be configured and arranged to cooperate with one or more corresponding recesses on the outer sleeve. In other embodiments, the or each rib of the upper housing portion may be configured and arranged to frictionally engage an inner wall of the outer sleeve.

[0075] This provides the advantage that rotational movement of the upper housing portion (specifically, within the outer sleeve) is prevented. The hollow needle is therefore maintained in a substantially vertical (or longitudinally extending) manner. In this way, during use, the hollow needle is caused to move substantially (or completely) axially during actuation, rather than at an angle relative to the pierceable seal. Therefore, a consistent piercing action can be achieved.

[0076] In some embodiments, the lower housing portion includes at least one outwardly extending flange. The outwardly extending flange can extend outwardly (i.e., away from the central longitudinal axis of the lower housing portion) from an outer surface of the lower housing portion. In some embodiments, the lower housing portion includes a pair of outwardly extending flanges. In some embodiments, the pair of outwardly extending flanges are diametrically opposed. In some embodiments, the or each outwardly extending flange or flanges can be configured and arranged to be received within a corresponding slot or slots of the outer sleeve.

[0077] This provides the advantage that the lower housing part is held fixedly in a stationary manner on the outer sleeve, for example relative to the upper housing part, and therefore a more reliable operation of the connector can be ensured.

[0078] In certain embodiments, the actuation mechanism includes a collar operably coupled to the hollow needle, the collar including at least one actuatable lug configured to move the collar along the central longitudinal axis, the at least one actuatable lug of the collar protruding at least partially through at least one slot of the outer sleeve. That is, in some embodiments, the outer sleeve further includes at least one slot, and the actuatable lug of the collar protrudes (at least partially through) the at least one slot. Such at least one slot may be different from or the same as the at least one slot through which the actuatable lug of the upper housing portion at least partially protrudes (i.e., separate slots or integral slots may be present for both the actuatable lug of the collar and the actuatable lug of the upper housing portion).

[0079] In some instances, axial translation of the collar (and thus the hollow needle) along the central longitudinal axis toward the proximal end causes the hollow needle to pierce the pierceable hermetic seal of the lower housing portion.

[0080] This provides the advantage that the connector can be actuated in a sequential manner by an automated system. Further, this provides the advantage that the piercing in a sequential manner can be controlled by an automated system. Additionally, the use of such a connector (and the piercing of its seal) is less susceptible to human error.

[0081] In some embodiments, the actuatable lug of the collar has a circular or cruciform (ie, cross-shaped) cross-section.

[0082] In some embodiments, the collar includes a plurality of actuatable lugs. In some embodiments, the outer sleeve includes a plurality of slots. In certain embodiments, each actuatable lug protrudes at least partially (or mostly or completely) through one of the plurality of slots.

[0083] In some embodiments, the collar includes a pair of diametrically opposed actuatable lugs. In some embodiments, the outer sleeve includes a pair of diametrically opposed slots. In certain embodiments, each actuatable lug of the collar protrudes at least partially (or mostly or completely) through one of the pair of slots.

[0084] In certain embodiments, the outer sleeve includes a first plurality of slots, each configured and arranged to allow the actuatable lugs of the upper housing portion to at least partially (or mostly or completely) protrude therethrough, and the outer sleeve includes a second plurality of slots, each configured and arranged to allow the actuatable lugs of the collar to at least partially (or mostly or completely) protrude therethrough.

[0085] That is, in certain embodiments, there is a separate slot for the actuatable lug on the upper housing portion and a separate slot for the actuatable lug on the collar. In some examples, each of the first plurality of slots is spaced approximately 120° apart around the outer sleeve. In some examples, each of the second plurality of slots can be spaced 120° apart around the outer sleeve and offset relative to the first plurality of slots.

[0086] This provides the advantage that separate actuation mechanisms can be provided for engaging the individual actuatable lugs.

[0087] In certain embodiments, the outer sleeve includes a first slot and a second slot diametrically opposite the first slot, one of the pair of actuatable lugs on the collar and one of the pair of actuatable lugs on the upper housing portion protruding at least partially (or mostly or completely) through the first slot, and the other of the pair of actuatable lugs on the collar and the other of the pair of actuatable lugs on the upper housing portion protruding at least partially (or mostly or completely) through the second slot.

[0088] That is, the first slot has both an actuatable lug on the collar and an actuatable lug on the upper housing portion protruding (at least partially) therethrough, and similarly, the second slot has both an actuatable lug on the collar and an actuatable lug on the upper housing portion protruding (at least partially) therethrough.

[0089] Specifically, the outer sleeve includes a sidewall portion having a first slot and a second slot, the first slot receiving a first actuable lug on the upper housing portion and a first actuable lug on the collar, and the second slot, diametrically opposite the first slot, receiving a second actuable lug on the upper housing portion and a second actuable lug on the collar.

[0090] More specifically, in certain embodiments, the outer sleeve includes a sidewall having a first slot and a second slot, the second slot being diametrically opposite the first slot; the upper housing portion includes a first actuatable lug extending from a body portion of the upper housing portion and a second actuatable lug extending from the body portion of the upper housing portion, the first and second actuatable lugs being diametrically opposite one another; the collar includes a first actuatable lug extending from an outer wall portion of the collar and a second actuatable lug extending from an outer wall portion of the collar, the first and second actuatable lugs being diametrically opposite one another; the first actuatable lug of the upper housing and the first actuatable lug of the collar protrude at least partially through the first slot of the outer sleeve, and the second actuatable lug of the upper housing and the second actuatable lug of the collar protrude at least partially through the second slot of the outer sleeve.

[0091] This provides the advantage that an actuation mechanism with a smaller footprint can be utilized.

[0092] Generally, one or more slots in the outer sleeve can provide access to actuatable lugs on the upper housing portion and / or collar. The one or more slots can provide user access (i.e., manual access) or robotic access (i.e., automated access).

[0093] In certain embodiments, the outer sleeve includes a sidewall (preferably a substantially cylindrical sidewall). In some embodiments, one or more slots (i.e., a first slot or slots and / or a second slot or slots) are formed in the sidewall. The outer sleeve may be formed from two half-pipe sections that are operably coupled together to form the outer sleeve. The two half-pipe sections may be welded, glued, clipped, or the like, to one another.

[0094] In certain embodiments, the outer sleeve includes a front wall, a rear wall, and a side wall that adjoins the front and rear walls. There can be two side walls. In some examples, one or more slots (i.e., a first slot or a plurality of slots and / or a second slot or a plurality of slots) are provided in the or each side wall. The outer sleeve can further include a protective wall that forms a gripping area of ​​the outer sleeve and extends over the one or more slots. In this manner, the protective wall is configured to prevent manual access to components within the outer sleeve while enabling automated actuation of the connector. The protective wall can be knurled or otherwise configured to enhance gripping by a user.

[0095] In certain embodiments, at least one gaiter is provided to surround the hollow needle. In some instances, a single flexible gaiter is provided to surround the hollow needle and the collar. In other instances, a first flexible gaiter is provided to surround a first portion of the hollow needle, and a second flexible gaiter is provided to surround a second portion of the hollow needle. The first flexible gaiter can extend from an upper surface of the collar to a lower surface of the upper housing portion. The second flexible gaiter can extend from a lower surface of the collar to an upper surface of the lower housing portion. The at least one gaiter can surround the hollow needle in a sterile (or aseptic) environment. Thus, the at least one gaiter can aseptically seal the hollow needle therein. Thus, the at least one gaiter can hermetically seal the hollow needle therein.

[0096] This provides the advantage that a sterile environment is guaranteed around the hollow needle. Furthermore, needlestick injuries can be prevented.

[0097] In certain embodiments, the hollow needle is a double-ended needle.

[0098] This provides the advantage that two receptacles (optionally including a septum) can be easily connected.

[0099] In certain embodiments, both the proximal and distal ends of the connector housing include pierceable seals.

[0100] In certain embodiments, both hollow needles are mounted within the housing, with each end of the both hollow needles facing a pierceable seal at either the proximal or distal end of the housing when biased and mounted within the housing.

[0101] This provides the advantage that the hollow needle can be maintained in a sterile (or aseptic) environment.

[0102] In certain embodiments, the first end of the double-headed hollow needle (i.e., adjacent the proximal end of the housing) includes a pencil-point closed end and a port adjacent the pencil-point closed end, such an end may be referred to as a Whitacre end.

[0103] This provides the advantage that the first end of the double-ended needle can repeatedly pierce a resealable pierceable seal, for example, in a connector, container, or bioreactor, ensuring the resealability of such a seal, thus maintaining a sterile environment.

[0104] In certain embodiments, the second end of the double hollow needle (ie, adjacent the distal end of the housing) comprises an open end (eg, a beveled open end, etc.).

[0105] This provides the advantage that the second end of the double-ended needle can easily pierce the pierceable seal, among other things, a smaller actuation force may be required for the second end to pierce the pierceable seal.

[0106] In certain embodiments, the connector further includes an actuation mechanism that allows dual hollow needles to pierce the pierceable seals at both the proximal and distal ends.

[0107] In certain embodiments, the actuation mechanism includes an outer sleeve configured to allow both hollow needles to pierce the respective pierceable seals and connect to the first receptacle and the second receptacle.

[0108] This provides the advantage that in some embodiments the hollow needles can be sterilely connected to (or communicate with) receptacles at each end of the housing.

[0109] In some embodiments, the connector further includes an outer sleeve. In some embodiments, the connector housing includes the outer sleeve. In some embodiments, the actuation mechanism includes the outer sleeve. The outer sleeve can be positioned over the connector housing. The outer sleeve can be positioned over the connector housing between a proximal end and a distal end of the connector housing. In some embodiments, the outer sleeve is rotatable. In some embodiments, the outer sleeve is rotatable in both directions.

[0110] In some embodiments, the outer sleeve is configured such that at least partial rotation of the outer sleeve causes axial translation of the hollow needle to pierce at least one pierceable seal positioned at an end of the connector housing, which can be, for example, a pierceable seal positioned at the proximal or distal end of the housing.

[0111] In some embodiments, the outer sleeve is configured such that at least partial rotation of the outer sleeve causes axial translation of the pierceable seal to contact the hollow needle and pierce a pierceable seal positioned at an end of the connector housing, which can be, for example, a pierceable seal positioned at the proximal or distal end of the housing.

[0112] In some embodiments, the outer sleeve is configured such that partial rotation of the outer sleeve causes axial translation of pierceable seals at both the proximal and distal ends of the housing, both of which contact the hollow needle and pierce the pierceable seals at both the proximal and distal ends of the connector housing.

[0113] In certain embodiments, the outer sleeve is configured such that at least partial rotation of the outer sleeve causes axial translation of the hollow needle to pierce the respective pierceable seals and connect to (or communicate with) the first receptacle and the second receptacle.

[0114] In certain embodiments, the outer sleeve is configured such that at least partial rotation of the outer sleeve causes axial translation of the hollow needle and axial translation of the pierceable seal.

[0115] In some specific embodiments, the connector includes a pierceable seal at the proximal end of the housing and a pierceable seal at the distal end of the housing, and the outer sleeve can be configured such that at least partial rotation of the outer sleeve causes axial translation of the hollow needle and axial translation of the pierceable seal, such that the hollow needle pierces the pierceable seal at the distal end and the pierceable seal at the proximal end of the connector housing.

[0116] Partial rotation of the outer sleeve to move the hollow needle or pierceable seal advantageously allows for easy piercing of one or more pierceable seals. Advantageously, this can be in a fluid-tight manner. Advantageously, this can be in a sterile manner.

[0117] In certain embodiments, the outer sleeve is configured such that at least partial rotation of the outer sleeve causes axial translation of both hollow needles to pierce their respective pierceable seals and connect to (or communicate with) the first receptacle and the second receptacle.

[0118] This provides the advantage that the connector can be manually actuated without the risk of needle stick injury.

[0119] In some embodiments, the outer sleeve is configured such that at least partial axial translation of the outer sleeve causes axial translation of the hollow needle to pierce at least one pierceable seal positioned at an end of the connector housing, which can be, for example, a pierceable seal positioned at the proximal or distal end of the housing.

[0120] In some embodiments, the outer sleeve is configured such that at least partial axial translation of the outer sleeve causes axial translation of the pierceable seal to contact the hollow needle and pierce a pierceable seal positioned at an end of the connector housing, which can be, for example, a pierceable seal positioned at the proximal or distal end of the housing.

[0121] In some embodiments, the outer sleeve is configured such that partial axial translation of the outer sleeve causes axial translation of the pierceable seals at both the proximal and distal ends of the housing, both of which contact the hollow needle and pierce the pierceable seals at both the proximal and distal ends of the connector housing.

[0122] In certain embodiments, the outer sleeve is configured such that at least partial axial translation of the outer sleeve causes axial translation of the hollow needle to pierce the respective pierceable seals and connect to (or communicate with) the first receptacle and the second receptacle.

[0123] In certain embodiments, the outer sleeve is configured such that at least partial axial translation of the outer sleeve causes axial translation of the hollow needle and axial translation of the pierceable seal.

[0124] In some specific embodiments, the connector includes a pierceable seal at the proximal end of the housing and a pierceable seal at the distal end of the housing, and the outer sleeve can be configured such that at least partial axial translation of the outer sleeve causes axial translation of the hollow needle and axial translation of the pierceable seal, such that the hollow needle pierces the pierceable seal at the distal end and the pierceable seal at the proximal end of the connector housing.

[0125] The partial axial translation of the outer sleeve to move the hollow needle or pierceable seal advantageously allows for easy piercing of one or more pierceable seals. Moreover, the axial translation of the outer sleeve ensures that such connectors are more suitable for automated processing. Advantageously, this can be in a fluid-tight manner. Advantageously, this can be in a sterile manner.

[0126] In certain embodiments, the outer sleeve is configured such that at least partial axial translation of the outer sleeve causes axial translation of both hollow needles to pierce their respective pierceable seals and connect to (or communicate with) the first receptacle and the second receptacle.

[0127] This provides the advantage that the connector can be manually actuated without the risk of needle stick injury.

[0128] In certain embodiments, the connector further comprises a releasable attachment mechanism. The connector may be releasably attached to, for example, one or more containers, ports, connectors, or bioreactors. In some embodiments, the releasable attachment mechanism comprises threads. In some embodiments, the connector comprises threads that correspond to threads on a corresponding element to which the connector may be releasably attached. In some embodiments, the housing comprises the releasable connection mechanism. In some embodiments, the housing comprises the releasable connection mechanism at a proximal end of the housing. In some embodiments, the housing comprises the releasable connection mechanism at a distal end of the housing. In some embodiments, the outer sleeve of the connector comprises the releasable attachment mechanism. In some embodiments, the outer sleeve comprises the releasable connection mechanism at a proximal end of the outer sleeve. In some embodiments, the outer sleeve comprises the releasable connection mechanism at a distal end of the outer sleeve.

[0129] In some embodiments, the connector can be rotated to releasably attach to the corresponding element. In some embodiments, the corresponding element can be rotated to releasably attach to the connector.

[0130] In certain embodiments, the outer sleeve is configured such that the outer sleeve causes a releasable locking engagement between a proximal end of the outer sleeve and a portion of a corresponding receptacle (e.g., a second receptacle) of the connector.

[0131] This provides the advantage that a user can easily identify, either tactilely, visually, or tactile-visually, that a connector is properly connected to a corresponding receptacle.

[0132] In some embodiments, the outer sleeve includes threads. In some embodiments, the outer sleeve includes threads at a proximal end of the outer sleeve. In some embodiments, the outer sleeve includes threads at a distal end of the outer sleeve. In some embodiments, the outer sleeve includes threads on an inner surface of the outer sleeve.

[0133] In certain embodiments, the hollow needle is bias-mounted (at least partially) within the housing.

[0134] This provides the advantage that the hollow needle is arranged to move, thereby preventing needlestick injuries. Advantageously, the hollow needle can be held in a safe position but can be moved to pierce one or more pierceable seals in use.

[0135] In certain embodiments, the hollow needles are biased toward the proximal end of the housing by a biasing mechanism, preferably a helical spring, which can extend between a collar (operably coupled to the hollow needles) and the upper housing portion.

[0136] This provides the advantage that sequential piercing of the pierceable hermetic seals is achieved through a single spring.

[0137] In some embodiments, the upper housing portion can include at least one actuatable lug. The at least one actuatable lug can extend through at least one slot in the outer sleeve of the connector. Upon actuation of the at least one actuatable lug, the upper housing portion is caused to fold relative to the lower housing portion, causing the hollow needle to pierce a pierceable closure seal in the lower housing portion. Further actuation causes the spring to compress, subsequently piercing the pierceable closure seal of the upper housing portion.

[0138] This provides the advantage that sequential drilling can be easily and precisely controlled, and therefore the connector is suitable for automation.

[0139] In certain embodiments, the hollow needles are biased toward the distal end of the housing by a biasing mechanism, preferably a helical spring, which can extend between a collar (operably coupled to the hollow needles) and the lower housing portion.

[0140] This provides the advantage that sequential piercing of the pierceable hermetic seals is achieved through a single spring.

[0141] In some embodiments, the lower housing portion can include at least one actuatable lug. The at least one actuatable lug can extend through at least one slot in the outer sleeve of the connector. Upon actuation of the at least one actuatable lug, the lower housing portion is caused to fold relative to the upper housing portion, causing the hollow needle to pierce a pierceable closure seal in the upper housing portion. Further actuation causes the spring to compress, subsequently piercing the pierceable closure seal of the lower housing portion.

[0142] This provides the advantage that sequential drilling can be easily and precisely controlled, and therefore the connector is suitable for automation.

[0143] In certain embodiments, the hollow needles are biased toward the proximal end of the housing by a first biasing mechanism and toward the distal end of the housing by a second biasing mechanism.

[0144] In certain embodiments, the first biasing mechanism provides a first biasing force and the second biasing mechanism provides a second biasing force, wherein the first biasing force and the second biasing force are approximately equal.

[0145] This provides the advantage that the hollow needles can pierce each septum at approximately the same time.

[0146] In certain embodiments, the first biasing mechanism provides a first biasing force and the second biasing mechanism provides a second biasing force, the first biasing force being greater than the second biasing force.

[0147] This provides the advantage that the hollow needle can first pierce the second septum and secondly pierce the first septum, thereby providing sequential piercing of the septa.

[0148] In certain embodiments, the first biasing mechanism provides a first biasing force and the second biasing mechanism provides a second biasing force, the second biasing force being greater than the first biasing force.

[0149] This provides the advantage that the hollow needle can first pierce a first septum and then a second septum, thereby providing sequential piercing of the septa.

[0150] In certain embodiments, the first biasing mechanism includes a resilient or non-resilient biasing mechanism.

[0151] In certain embodiments, the second biasing mechanism includes a resilient or non-resilient biasing mechanism.

[0152] In certain embodiments, the first biasing mechanism, or the second biasing mechanism, or both the first and second biasing mechanisms include a helical spring or a deformable elastomeric material.

[0153] In certain embodiments, the first end, or the second end, or both the first and second ends of both hollow needles are beveled, i.e., in certain embodiments, either the first end or the second end of both hollow needles is beveled, or both the first and second ends are beveled.

[0154] This provides the advantage that a fluid can be directly connected into the through bore of the hollow needle, thereby ensuring, for example, that a material is completely transferred from a first receptacle to a second receptacle. Moreover, leakage of material can be reduced (or avoided). Moreover, material (e.g., particles in a fluid) can also be directed through the hollow needle, such that the material can be efficiently and effectively transferred, for example, between receptacles.

[0155] In certain embodiments, the distal end of the housing is connectable to the first receptacle. In certain embodiments, the proximal end of the housing is connectable to the first receptacle.

[0156] In certain embodiments, the distal end of the housing includes a threaded portion configured to engage a corresponding threaded portion of the first receptacle.

[0157] In certain embodiments, the threaded portion includes a septum seal having a central frusto-conical recess.

[0158] This provides the advantage that fluid is completely transferred, for example, from a receptacle to a connector. Moreover, leakage of material can be reduced (or avoided). Moreover, material (e.g., solid particles in a fluid) can also be directed through the hollow needle, so that material can be efficiently and effectively transferred, for example, between receptacles.

[0159] In certain embodiments, the threaded portion includes an anti-rotation member.

[0160] In certain embodiments, the anti-rotation member includes a plurality of angled notches configured to engage a plurality of corresponding notches or lips on the receptacle.

[0161] In certain embodiments, the pierceable seal at the or each end of the housing comprises a pierceable hermetic seal.

[0162] This provides the advantage that a sterile (or aseptic) environment can be maintained.

[0163] In some embodiments, the pierceable seal comprises a pierceable hermetic seal. In some embodiments, the pierceable seal comprises a resealable pierceable seal. In some embodiments, the pierceable seal comprises a resealable pierceable hermetic seal. In certain embodiments, the resealable pierceable hermetic seal comprises a septum seal. In some embodiments, the resealable pierceable seal is self-sealing. In some embodiments, the resealable hermetic seal is self-sealing. In some embodiments, the septum seal is self-sealing. In some embodiments, the septum seal is a self-sealing septum seal. In certain embodiments, the pierceable seal is a self-sealing septum seal. In certain embodiments, the pierceable seal is a self-sealing hermetic seal.

[0164] This provides the advantage that the pierceable hermetic seal is resealable, allowing for aseptic (or sterile) connections, disconnections and reconnections to be made.

[0165] In certain embodiments, the pierceable seal includes an annular septum seal. That is, the pierceable seal includes a septum seal formed as an annular body. The annular body may be formed as a raised annular portion surrounding a circular flat base. The hollow needle may be configured to pierce through the circular flat base. The raised annular portion may be configured to engage (e.g., face-to-face engagement) with a corresponding pierceable seal (e.g., another annular septum seal (e.g., corresponding raised annular portions in face-to-face engagement or received within each other's annular body), a flat septum seal, etc.).

[0166] This provides the advantage that the annular raised portion ensures sterility within the enclosed area to be pierced, and therefore a sterile (or aseptic) environment can be maintained.

[0167] In certain embodiments, the connector further includes a cover disposed over the pierceable seal at the or each end of the connector housing.

[0168] In certain embodiments, the cover comprises a removable sterile paper seal.

[0169] In certain embodiments, the connector further includes a sterile seal system including a sterile membrane and a clip portion, the sterile membrane being disposed over the pierceable hermetic seal at the or each end of the connector housing and operably coupled to the clip portion.

[0170] This provides the advantage that the sterile membrane ensures a sterile environment at the or each pierceable hermetic seal during handling and / or set-up of connectors and / or other components.

[0171] In certain embodiments, the clip portion is slidably operably connected to the connector such that the clip portion is slidable between a first configuration and a second configuration, wherein in the first configuration the sterile membrane is disposed over the or each pierceable hermetic seal and wherein in the second configuration the sterile membrane is removed from the or each pierceable hermetic seal.

[0172] This provides the advantage that the sterile sealing system can be removed by an automated system prior to actuation, thus ensuring a sterile environment during use.

[0173] In some embodiments, the clip portion is slidably operably connected to the outer sleeve of the connector.

[0174] In certain embodiments, the clip portion includes a rail configured to be slidably operably received within the rail-receiving portion of the outer sleeve of the connector.

[0175] In certain embodiments, the clip portion includes at least one (preferably two) protruding shoulders. In some instances, the at least one protruding shoulder is configured to be operably engaged by a sterile seal actuation mechanism. More specifically, in some embodiments, the sterile seal actuation mechanism is arranged to apply a biasing force onto the or each shoulder.

[0176] In certain embodiments, the clip portion includes at least a locating element configured and arranged to cooperate with a corresponding locating element on the outer sleeve, hi certain embodiments, the clip portion includes outwardly extending ribs (e.g., longitudinal ribs, etc.) configured and arranged to cooperate with (e.g., frictionally engage) a corresponding rib or recess on the outer sleeve.

[0177] This provides the advantage that the clip portions (and thus the sterile seal system) are maintained in the proper position prior to engagement by the sterile seal actuation mechanism.

[0178] In some embodiments, the sterile membrane comprises a sterile paper seal. Preferably, the sterile membrane comprises a sterile polyethylene film.

[0179] In some embodiments, the sterile membrane includes at least one fold, thereby forming a first surface configured to provide a sterile seal for the or each pierceable closure seal, and a second surface configured to mate with a corresponding sterile membrane. Any number of folds may be provided.

[0180] In certain embodiments, the connector is a sterile connector.

[0181] In certain embodiments, at least one end of the connector is removably engageable with the receptacle by rotating the connector.

[0182] In certain embodiments, the first end of the hollow needle can be fluidly connected to the first receptacle, i.e., there can be a fluid connection between the first end of the hollow needle and the first receptacle.

[0183] In certain embodiments, the first end of the hollow needle may be fluidly connectable to a first receptacle.

[0184] In certain embodiments, the actuation mechanism acts on the housing or the hollow needle to create fluid communication through the pierceable seal.

[0185] In certain embodiments, the actuation mechanism acts directly on the housing. In other embodiments, the actuation mechanism acts directly on the hollow needle. The term "directly" is used to mean that the actuation mechanism acts on the respective component without any intervening or intermediate parts.

[0186] In some embodiments, the first receptacle can include a predetermined volume (e.g., a volume of fluid). In some embodiments, the second receptacle can include a predetermined volume (e.g., a volume of fluid).

[0187] The present invention also provides a sterile sealing system as described herein.

[0188] In some embodiments, the sterile seal system can include a clip portion and a sterile membrane operably coupled to the clip portion.

[0189] In some embodiments, the clip portion can include a front wall, a rear wall, side walls adjoining the front and rear walls, and a bottom wall. The clip portion can include a hollow body defined by the front, rear, side, and bottom walls. The hollow body can include one or more reinforcing ribs extending from the inner surface of the front wall to the inner surface of the rear wall. The front wall can include one or more protruding shoulders configured to be engaged by a sterile seal actuation mechanism. The sterile seal actuation mechanism can be configured to provide a biasing force on the or each protruding shoulder. The bottom wall can include an axially protruding member configured and arranged to cooperate with a receiving member of a corresponding sterile seal system (e.g., of a container, etc.). The clip portion can include one or more positioning elements (e.g., an outwardly extending rib or multiple outwardly extending ribs, as described above) on one or both side walls.

[0190] In some embodiments, the clip portion can include one or more rails configured to be slidably received within a corresponding rail-receiving portion of the connector.

[0191] In some embodiments, the sterile membrane can include a sterile paper seal. Preferably, the sterile membrane includes a sterile polyethylene film. The sterile membrane can include at least one fold, thereby forming a first surface configured to aseptically seal against a pierceable closure seal (e.g., a septum seal) and a second surface configured to mate with a corresponding sterile membrane.

[0192] The present invention also relates to a method for removing a sterile sealing system from a connector.

[0193] In a first step, a connector and a sterile sealing system are provided as described herein.

[0194] In a second step, a sterile seal actuation mechanism is provided. Optionally, the sterile actuation mechanism may be provided as part of the instrument (e.g., the incubator or housing, etc.).

[0195] In a third step, a sterile seal actuation mechanism engages a clip portion of the sterile seal system. Optionally, the sterile seal actuation mechanism engages one or more shoulders of the clip portion.

[0196] In a fourth step, the sterile seal actuation mechanism applies a force to the clip portion to remove (at least partially) the sterile seal system from the connector. Optionally, the force can be a pushing or pulling force.

[0197] In a fifth step, at least partial removal of the clip portion causes at least partial removal of the sterile membrane from the pierceable hermetic seal, thereby exposing at least a portion (preferably all) of the pierceable hermetic seal.

[0198] The present invention also provides a system, the system comprising: - a connector as described herein; - a first receptacle removably coupled to one end of the connector, the first receptacle being connected to a first end of the hollow needle; a second receptacle removably coupled to one end of the connector, the second receptacle being connected to a second end of the hollow needle; and The present invention provides a system including:

[0199] This provides the advantage that a first receptacle can be connected, disconnected, and reconnected to a second receptacle by the connector. More specifically, the connection, disconnection, and reconnection can be accomplished in an aseptic (or sterile) manner. Moreover, the system may be more suitable for automated processes and may be easier to handle and use.

[0200] In certain embodiments, the first receptacle or the second receptacle, or both the first receptacle and the second receptacle, include a pierceable seal coaxially aligned with a pierceable seal at the or each end of the connector housing.

[0201] In certain embodiments, the or each pierceable seal of the first receptacle or the second receptacle, or both the first receptacle and the second receptacle, comprises a pierceable hermetic seal, and the or each pierceable seal of the housing comprises a pierceable hermetic seal.

[0202] In certain embodiments, one or more of the pierceable hermetic seals include a septum seal. That is, in certain embodiments, the or each pierceable seal of the first receptacle or the second receptacle, or both the first receptacle and the second receptacle, includes a septum seal. Additionally or alternatively, in certain embodiments, the or each pierceable hermetic seal of the housing includes a septum seal.

[0203] In certain embodiments, the or each pierceable seal of the first receptacle or the second receptacle, or both the first receptacle and the second receptacle, includes a sterile seal system including a sterile membrane configured to mate with a sterile membrane of the connector.

[0204] In certain embodiments, the system further comprises a cell processing platform or vacutainer.

[0205] In certain embodiments, the first receptacle may be fluidly connected to a first end of the hollow needle.

[0206] In certain embodiments, the second receptacle may be fluidly connected to the second end of the hollow needle.

[0207] In some embodiments, the first receptacle can include a predetermined volume (e.g., a volume of fluid). In some embodiments, the second receptacle can include a predetermined volume (e.g., a volume of fluid).

[0208] The present invention also provides a system, the system comprising: - with a container or vacutainer; - a connector as described herein; Includes; - A system is provided, wherein a container or vacutainer is coupled to a distal end of the housing of the connector, and a first end of the hollow needle is connected to the container or vacutainer.

[0209] This provides the advantage that the container or vacutainer can be connected, disconnected, and reconnected to a second receptacle by the connector. More specifically, the connection, disconnection, and reconnection can be accomplished in an aseptic (or sterile) manner. Moreover, the system may be more suitable for automated processes and may be easier to handle and use.

[0210] In certain embodiments, the receptacle or bioreactor or container or vacutainer contains a predetermined volume of fluid.

[0211] In certain embodiments, the first end of the hollow needle may be fluidly connected to (eg, fluidly connected to) a container or vacutainer.

[0212] According to another aspect of the present invention, there is also provided a receptacle including a connector as described herein. The receptacle may comprise a container or a vacutainer.

[0213] According to another aspect of the present invention, there is provided a method of connecting two receptacles, the method comprising: - providing a connector as described herein; - connecting a distal end of the connector housing to a first receptacle, the first receptacle adapted to connect with a first end of the hollow needle; - removably connecting a proximal end of the housing of the connector to a second receptacle including a pierceable seal such that the pierceable seal of the connector is coaxially aligned with the pierceable seal of the second receptacle; - actuating the hollow needle to pierce the pierceable seal of the housing of the connector and through the pierceable seal of the second receptacle, thereby connecting the first receptacle and the second receptacle; A method is provided, comprising:

[0214] This provides the advantage that a first receptacle can be connected, disconnected, and reconnected to a second receptacle by the connector. More specifically, the connection, disconnection, and reconnection can be achieved in an aseptic (or sterile) manner. Moreover, the method may be more suitable for automated processes and may be easier to handle and use. The method is easy to use and efficient.

[0215] In certain embodiments, actuating the hollow needle includes fluidly connecting the first receptacle to the second receptacle.

[0216] In certain embodiments, actuating the hollow needle includes fluidly connecting the first receptacle to the second receptacle, thereby forming communication between the first receptacle and the second receptacle.

[0217] In certain embodiments, connecting the distal end to the first receptacle includes removably connecting the distal end to the first receptacle.

[0218] In certain embodiments, the method further includes at least partially rotating the actuation mechanism, thereby causing the hollow needle to pierce the pierceable hermetic seal of the housing of the connector and the pierceable seals of the first receptacle, or the second receptacle, or both the first receptacle and the second receptacle.

[0219] In certain embodiments, the method further includes at least partially folding an upper housing portion of the connector along the central longitudinal axis relative to a lower housing portion of the connector, thereby causing the hollow needle to pierce a pierceable hermetic seal of the connector housing and a pierceable seal of the first receptacle.

[0220] In some embodiments, the step of at least partially folding the upper housing portion includes engaging one or more actuatable lugs of the upper housing portion with an actuation mechanism; and actuating the or each actuatable lug of the upper housing portion to fold the upper housing portion along the central longitudinal axis relative to the lower housing portion of the connector.

[0221] In some embodiments, the step of at least partially folding the upper portion of the connector causes the hollow needle to pierce a pierceable hermetic seal of the upper housing portion.

[0222] In certain embodiments, the method further includes at least partially axially translating the hollow needle along the central longitudinal axis toward the proximal end of the connector, thereby causing the hollow needle to pierce the pierceable hermetic seal of the connector housing and the pierceable seal of the second receptacle.

[0223] In some embodiments, the step of at least partially axially translating the hollow needle includes engaging one or more actuatable lugs of the collar (operably coupled to the hollow needle) with an actuation mechanism, and actuating the or each actuatable lug of the collar to axially translate the collar (and thus the hollow needle) toward the proximal end of the connector.

[0224] In some embodiments, the step of at least partially axially translating the hollow needle causes the hollow needle to pierce a pierceable hermetic seal of the lower housing portion.

[0225] In certain embodiments, the or each pierceable seal is a pierceable hermetic seal.

[0226] In certain embodiments, the or each pierceable hermetic seal comprises a septum seal.

[0227] According to yet another aspect of the present invention, there is provided a connector as described herein, and an actuation system configured to actuate the connector.

[0228] In certain embodiments, the actuation system is configured to actuate a needle-safe feature of the connector, where the actuation mechanism acts on the hollow needle, i.e., causes piercing of the hollow needle through the or each pierceable seal and / or sterile seal system, as described herein. The actuation system can be external to the connector. The actuation system can be formed as part of an instrument (e.g., an incubator, etc.).

[0229] According to yet another aspect of the present invention, there is provided a sterile connection arrangement, the sterile connection arrangement comprising: - a first sterile seal system including a first clip portion and a first sterile membrane, the first clip portion including a first connecting element, the first sterile membrane operably connected to the first clip portion and disposed over at least a portion of the first pierceable seal; - a second sterile seal system including a second clip portion and a second sterile membrane, the second clip portion including a second connecting element, the second connecting element configured to operably couple to the first connecting element, the second sterile membrane operably coupled to the second clip portion and configured to operably couple to the first sterile membrane, the second sterile seal system being disposed over at least a portion of the second pierceable seal; A sterile connection construct is provided, comprising:

[0230] This provides the advantage that the two fluid volumes can be connected and disconnected aseptically, particularly in a manner that is suitable for automation (e.g., suitable for use in an automated cell therapy and / or gene therapy manufacturing process).

[0231] In some embodiments, the first sterile membrane and / or the second sterile membrane may be disposed over most (or all) of their respective first pierceable seal and / or second pierceable seal.

[0232] In some embodiments, the first and / or second sterile sealing systems comprise a connector sterile sealing system, wherein the respective first and / or second pierceable seals are formed as part of the connector. The connector can be a connector as described herein. The first and / or second sterile sealing systems can be a connector sterile sealing system as described herein.

[0233] In some embodiments, the first sterile sealing system and / or the second sterile sealing system comprise a sterile sealing system such as a container, a bioreactor, or an interface plate, and the respective first and / or second pierceable seal is formed as part of the container, bioreactor, or interface plate.

[0234] In some embodiments, the first pierceable seal and / or the second pierceable seal comprise a seal as described herein (e.g., a hermetic seal, a resealable seal, or a septum seal, etc.).

[0235] In some embodiments, the first and / or second sterile seal systems are arranged to be activated by an activation system, and when the first and / or second sterile seal systems are activated, the first and / or second sterile membranes are caused to be removed from the respective first and / or second pierceable seals.

[0236] In some embodiments, the first clip portion is slidably operably coupled to a portion of the component on which the first pierceable seal is disposed. In some embodiments, the second clip portion is slidably operably coupled to a portion of the component on which the second pierceable seal is disposed. In certain embodiments, the first and / or second sterile seal systems are arranged to be actuated to slidably move the first and second clip portions, thereby removing the first and second sterile membranes from the respective first and second pierceable seals. In some embodiments, the first and / or second sterile seal systems are arranged to be actuated between a first configuration and a second configuration, wherein in the first configuration, each sterile membrane is at least partially disposed over its respective pierceable seal, and in the second configuration, each sterile membrane is removed from its respective pierceable seal.

[0237] According to yet another aspect of the present invention, there is provided a method of operating a sterile connection arrangement, the method comprising: - providing a first sterile seal system over at least a portion of the first pierceable seal, the first sterile seal system including a first clip portion including a first connecting element and a first sterile membrane operably connected to the first clip portion; - providing a second sterile seal system over at least a portion of the second pierceable seal, the second sterile seal system including a second clip portion including a second connecting element and a second sterile membrane operably connected to the second clip portion; - operably connecting a first connecting element to a second connecting element; - operably connecting a first sterile membrane to a second sterile membrane; - activating the first sterile seal system and / or the second sterile seal system, thereby removing the first sterile membrane from a portion of the first pierceable seal, removing the second sterile membrane from a portion of the second pierceable seal, and aseptically coupling an outer surface of the first pierceable seal to an outer surface of the second pierceable seal; A method is provided, comprising:

[0238] This provides the advantage that the two fluid volumes can be connected and disconnected aseptically, particularly in a manner that is suitable for automation (e.g., suitable for use in an automated cell therapy and / or gene therapy manufacturing process).

[0239] In some embodiments, the outer surface of the first pierceable seal is urged into sterile face-to-face engagement with the outer surface of the second pierceable seal.

[0240] In some embodiments, the method further comprises discarding the first sterile sealing system and / or the second sterile sealing system.

[0241] In some embodiments, the method further includes providing a fluid passageway through the first pierceable seal and the second pierceable seal. The fluid passageway may be provided by a connector described herein.

[0242] According to yet another aspect of the present invention, there is provided a sterile (or aseptic) connector for introducing material into or extracting material from at least one receptacle, the sterile connector comprising: - a housing extending between a distal end and a proximal end, the housing including a first pierceable seal at the distal end and a second pierceable seal at the proximal end; - a hollow needle mounted within the housing between a distal end and a proximal end, a first end of the hollow needle facing a first pierceable seal and connectable to a first receptacle, and a second end of the hollow needle facing a second pierceable seal and connectable to a second receptacle; an actuation mechanism acting on the housing or the hollow needle to enable the hollow needle to pierce the first pierceable seal and the second pierceable seal, thereby forming communication through the pierceable seals and allowing material to be transferred through the sterile connector; and A sterile (or aseptic) connector is provided, comprising:

[0243] In some embodiments, the sterile connector (or connector according to any of the above aspects) forms a sterile or sealed communication through the pierceable seal such that materials can be transferred through the sterile connector or connector in a sterile or sealed manner.

[0244] That is, the communication formed through one or more pierceable seals can be sterile (i.e., aseptic) or sealed (i.e., fluid-tight). Thus, a sterile or sealed environment is ensured for material transfer. In some embodiments, the communication is both sterile and sealed.

[0245] According to yet another aspect of the present invention, there is provided a sterile package or container comprising a connector or sterile connector as described herein.

[0246] That is, a sterile (or aseptic) package or container is provided having the connector or sterile connector packaged therein. The package or container can take the form of a packet, receptacle, box, bag, or the like. The package or container and / or the connector or sterile connector can be sterilized prior to (or subsequent to) packaging in the package or container. In some embodiments, the package or container (optionally including the connector or sterile connector) is gamma irradiated prior to (or subsequent to) packaging the connector or sterile connector in the package or container.

[0247] This offers the advantage that a completely sterile kit is provided to the user, thus providing a ready-to-use connector into a biological material handling system.

[0248] As used herein, the terms "sterilely attached," "attached in a sterile, tight manner," or "attached in a sterile manner" are used to describe a sterile attachment, including an attachment that is sufficiently tight to substantially prevent the passage of microorganisms.

[0249] As used herein, the term "axial translation" is used to describe movement parallel or substantially parallel to a longitudinal axis. When used to describe axial translation of a needle, it describes possible movement of the needle parallel to the longitudinal axis of the needle and connector. When used to describe axial translation of an outer sleeve, or housing, or other element, it describes movement of the outer sleeve, housing, or other element in a plane parallel to the longitudinal axis of the connector. The longitudinal axis of a connector extends between the proximal and distal ends of the connector. Also, the longitudinal axis of a connector extends between the proximal and distal ends of the connector housing.

[0250] As used herein, the terms "fold" or "foldable" are used to describe a reduction in length or a movement to reduce a length. Also, as used herein, the terms "fold" and "foldable" include bending, sliding, turning, and rotating, which may result in a reduction in length or height. For example, folding a housing or outer sleeve can include rotating the housing or outer sleeve such that the height or length of the housing or outer sleeve is reduced. The terms "folding" and "foldable" do not necessarily mean folding. The terms "folding" and "foldable" do not necessarily mean that the reduction in height or length cannot be reversed. As used herein, the terms "foldable" and "fold" also include partial folding or folding.

[0251] As used herein, the term "receptacle" is used to describe any vessel or container capable of holding a material (e.g., a solid or a fluid). The term "receptacle" as used herein includes both rigid and flexible receptacles (e.g., a sack, bag, bellows, bioreactor, or vacutainer, etc.).

[0252] As used herein, the term "double-ended hollow needle" is used to describe a hollow needle that is pointed (or sharp) on both ends.

[0253] As used herein, the term "material" is used to describe any substance. The term "material" includes one or more solids or fluids. The term "material" also includes gases, liquids, solutions, pastes, gels, and the like.

[0254] As used herein, the term "fluid" is used to describe gases and liquids (including solutions), but also includes granular solids, including powders. A granular solid need not be in solution. Likewise, a granular solid may be in solution; for example, a granular solid may be suspended in a liquid.

[0255] As used herein, the term "hermetic seal" is used to describe a seal that is fluid-tight.

[0256] As used herein, the term "partial rotation" is used to describe partial movement in a rotational manner and direction. It can include any and all amounts or distances of rotation. Specifically, in this specification, it will include rotation to a desired degree of rotation, for example, to complete a function, such as to pierce a seal or to releasably attach two items.

[0257] As used herein, the term "pierceable seal" is used to describe a seal that can be pierced by, for example, a needle.

[0258] The term "resealable pierceable seal" is used to describe a seal that is resealable in that it can be pierced, but once the cause of the piercing is removed (e.g., a hollow needle), the seal is able to automatically reseal. The term "pierceable seal" as used herein can be a "resealable pierceable seal."

[0259] As used herein, the term "pierce" is used to describe the perforation of a material such that a piercing element (e.g., a hollow needle) protrudes (at least partially) through the material.

[0260] As used herein, the term "self-sealing" with respect to a seal is used to describe a seal that is capable of automatically resealing itself after removal of the cause of the puncture or rupture, and thus is constructed and made from materials that allow the opening or rupture to close and reseal.

[0261] As used herein, "septum seal" is used to describe a seal that includes a material that provides a sterile seal, but which material can also be pierced by, for example, a needle.

[0262] As used herein, the term "self-sealing sterile seal" is used to describe a sterile seal that is capable of resealing after being punctured or punctured, for example, by a hollow needle, to re-provide a sterile seal.

[0263] Any feature or step described herein in relation to one embodiment, aspect, or example of a connector, or of a method for manufacturing a connector, or of an apparatus (or system) for manufacturing a connector, a component for the connector, or a kit of parts including the connector, or of a manufacturing apparatus of a method for manufacturing a connector, or an apparatus (including a system) for manufacturing a component for the connector, or a kit of parts including a plurality of manufacturing apparatuses suitable for manufacturing the connector or a component for the connector, may be equally applicable to any other embodiment, aspect, or example of any connector described herein, or of a method for manufacturing a component for the connector, or an apparatus (including a system) for manufacturing a component for the connector, or a kit of parts including a plurality of manufacturing apparatuses suitable for manufacturing the component or connector.

[0264] Reference will now be made to the drawings, which illustrate one or more embodiments described in the present disclosure. However, it will be understood that other embodiments not shown in the drawings are also within the scope of the present disclosure. Like numbers used in the figures refer to like components, steps, etc. 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 labeled with the same number. Additionally, the use of different numbers to refer to components in different figures is not intended to indicate that differently numbered components cannot be the same or similar other numbered components. The figures are presented for purposes of illustration, not limitation. Schematic drawings presented in the figures are not necessarily to scale.

[0265] Exemplary embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0266] [Figure 1] 1 is a perspective view of a connector according to an embodiment of the present invention including a removable sterile paper seal. [Figure 2] FIG. 2 is a cross-sectional view of the connector of FIG. 1. [Figure 3] 2 is a cross-sectional view of the connector of FIG. 1 when connected to a first container and a second container. [Figure 4] FIG. 4 is another cross-sectional view of FIG. 3. [Figure 5] 2 is a cross-sectional view of the connector of FIG. 1 when connected to a first container and a second container having another removable sterile paper seal, prior to assembly to a second container. [Figure 6] 2 is a cross-sectional view of the connector of FIG. 1 when connected to a first container and a second container. [Figure 7] 2 is a cross-sectional view of the connector of FIG. 1 when connected to a first container and a second container, with the removable sterile paper seal having been removed. [Figure 8] 2 is a cross-sectional view of the connector of FIG. 1 when connected to a first container and a second container, with a hollow needle connected to the second container. [Figure 9] 2 is a cross-sectional view of the connector of FIG. 1 when connected to a first container and a second container, with a hollow needle connected to the first container and the second container. FIG. [Figure 10] 10 is another view of FIG. 9 in which fluid may be transferred between a first container and a second container. [Figure 11] 2 is a cross-sectional view of the connector of FIG. 1 when connected to a first container and a second container after a fluid connection has been made. [Figure 12] FIG. 10 is a side view of a connector according to another embodiment of the present invention when connected to a first container and a second container. [Figure 13] FIG. 13 is a cross-sectional view of FIG. 12. [Figure 14]13 is a cross-sectional view of FIG. 12 when connected to a first container and a second container before a fluid connection is made. [Figure 15] FIG. 13 is a cross-sectional view of FIG. 12, with the hollow needle connected to a second container. [Figure 16] 13 is a cross-sectional view of FIG. 12, in which the hollow needle is connected to the first container and the second container. [Figure 17] 13 is a cross-sectional view of FIG. 12 when connected to a first container and a second container after a fluid connection has been made. [Figure 18] 13 is a cross-sectional view of FIG. 12 when the connector and first container are removed from the second container. [Figure 19] FIG. 10 is a perspective view of a connector according to another embodiment of the present invention. [Figure 20] FIG. 20 is a cross-sectional view of the connector of FIG. 19. [Figure 21] 20A-20E are (a) perspective, (b) top, (c) side, (d) cross-sectional, and (e) bottom views of the lower housing portion of the connector of FIG. 19. [Figure 22] 20A-20E are (a) perspective, (b) top, (c) side, (d) cross-sectional, and (e) bottom views of the upper housing portion of the connector of FIG. 19. [Figure 23] 20A-20E are (a) perspective, (b) top, (c) side, (d) cross-sectional, and (e) bottom views of the outer sleeve of the connector of FIG. 19. [Figure 24] 20A-20E are (a) perspective, (b) top, (c) side, (d) cross-sectional, and (e) bottom views of a sterile sealing system for use with the connector of FIG. 19. [Figure 25] 20A-20E are (a) perspective, (b) top, (c) side, (d) cross-sectional, and (e) bottom views of the collar of the connector of FIG. 19. [Figure 26] 20A-20E are (a) perspective, (b) top, (c) side, (d) cross-sectional, and (e) bottom views of the gaiter of the connector of FIG. 19. [Figure 27]20A-20E illustrate the connector of FIG. 19 (a) before activation, (b) after sterile connection to a first fluid volume, (c) after sterile connection to a second fluid volume, (d) after sterile disconnection from the second fluid volume, and (e) after sterile disconnection from the first fluid volume. [Figure 28] FIG. 10 is a perspective view of a connector according to another embodiment of the present invention. [Figure 29] FIG. 29 is a cross-sectional view of the connector of FIG. 28. [Figure 30] 29 illustrates the connector of FIG. 28 (a) before activation, (b) after sterile connection to a first fluid volume, (c) after sterile connection to a second fluid volume, (d) after sterile disconnection from the second fluid volume, and (e) after sterile disconnection from the first fluid volume. [Figure 31] FIG. 10 is a perspective view of a connector according to another embodiment of the present invention. [Figure 32] FIG. 32 is a cross-sectional view of the connector of FIG. 31. [Figure 33] FIG. 32 is another cross-sectional view of the connector of FIG. 31. [Figure 34] FIG. 32 is a top view of the connector of FIG. 31. [Figure 35] 32A-32E illustrate the connector of FIG. 31 (a) before activation, (b) after sterile connection to a first fluid volume, (c) after sterile connection to a second fluid volume, (d) after sterile disconnection from the second fluid volume, and (e) after sterile disconnection from the first fluid volume. [Figure 36] FIG. 10 is a perspective view of a connector according to another embodiment of the present invention. [Figure 37] FIG. 37 is a cross-sectional view of the connector of FIG. 36. [Figure 38] FIG. 37 is a top view of the connector of FIG. 36. [Figure 39] FIG. 37 is a bottom view of the connector of FIG. 36. [Figure 40] 37A-37E are (a) perspective, (b) top, (c) side, (d) bottom, and (e) cross-sectional views of the lower housing portion of the connector of FIG. 36. [Figure 41]37A-37E are (a) perspective, (b) top, (c) side, (d) bottom, and (e) cross-sectional views of the upper housing portion of the connector of FIG. 36. [Figure 42] 37A-37E are (a) perspective, (b) top, (c) side, (d) bottom, and (e) cross-sectional views of the collar and hollow needle of the connector of FIG. 36. [Figure 43] 37A-37E are (a) perspective, (b) top, (c) side, (d) bottom, and (e) cross-sectional views of the gaiter of the connector of FIG. 36. [Figure 44] (a) A perspective view of one portion of the outer sleeve, (b) a perspective view of another portion of the outer sleeve, (c) a bottom view of a portion of the outer sleeve, (d) a side view of a portion of the outer sleeve, (e) a top view of a portion of the outer sleeve, and (f) another side view of a portion of the outer sleeve of the connector of Figure 36. [Figure 45] 37A-37E are (a) perspective, (b) top, (c) side, (d) bottom, and (e) cross-sectional views of the inner components of the connector of FIG. 36. [Figure 46] 46A-46D are (a) top, (b) side, (c) bottom, and (d) cross-sectional views of the component of FIG. 45 including the outer sleeve. [Figure 47] (a) A perspective view, (b) a top view, (c) a side view, (d) a bottom view, and (e) a cross-sectional view of a sterile sealing system for use with the connector of Figure 36, and (f) a bottom view of the sterile sealing system connected to the connector of Figure 36. [Figure 48] 37A and 37B are a perspective view and a side view, respectively, of the transit cover and the transit cap, and a cross-sectional view of the connector of FIG. 36 with the transit cover and the transit cap attached, respectively. [Figure 49] 37A-37D are (a) a perspective view of a retention mechanism having the connector of FIG. 36 therein, (b) a top view of the retention mechanism, (c) a bottom view of the retention mechanism, and (d) a perspective view of the retention mechanism. [Figure 50](a) A perspective view of the retention mechanism, interface plate, bioreactor, and connector of FIG. 36 in use, and (b) a cross-sectional view of the retention mechanism, interface plate, and connector of FIG. 36 in use. [Figure 51] 1A and 1B are a perspective view and a cross-sectional view, respectively, of a connector according to another embodiment of the present invention. [Figure 52] 52A and 52B are perspective and cross-sectional views of the outer sleeve of the connector of FIG. 51. [Figure 53] 52A-52C are (a) perspective, (b) bottom, and (c) top views of a sterile sealing system for use in the connector of FIG. 51. [Figure 54] 54A and 54B are perspective and side views, respectively, of the outer sleeve of FIG. 52 with the sterile sealing system of FIG. 53 attached thereto. [Figure 55] 52A, 52B, and 52C are (a) perspective, (b) top, and (c) side views of the collar of the connector of FIG. 51. [Figure 56] 52A is a perspective view of a gaiter for use in the connector of FIG. 51, (b) a cross-sectional view, and (c) a perspective view of the gaiter and collar of the connector of FIG. 51. [Figure 57] 52A is a perspective view, FIG. 52B is a side view, and FIG. 52C is a bottom view of the lower housing portion of the connector of FIG. 51. [Figure 58] 52A-52D are (a) perspective, (b) side, (c) bottom, and (d) top views of the upper housing portion of the connector of FIG. 51. [Figure 59] FIG. 52 is a perspective view of a first step in the assembly of the connector of FIG. 51. [Figure 60] 52A and 52B are perspective and side views, respectively, of a second step in assembling the connector of FIG. 51. [Figure 61] 52A and 52B are (a) and (b) perspective and (b) side views of a third step in assembling the connector of FIG. 51. [Figure 62] 52A and 52B are (a) and (b) perspective and (b) side views of a fourth step in assembling the connector of FIG. 51. [Figure 63] 10A-10C illustrate a connector according to another embodiment of the present invention. [Figure 64] 64A-64C are (a) perspective, (b) rear, and (c) front views of a portion of the outer sleeve of the connector of FIG. 63. [Figure 65] 64A is a perspective view, FIG. 64B is a rear view, and FIG. 64C is a front view of another portion of the outer sleeve of the connector of FIG. 63. [Figure 66] 64A is a perspective view, FIG. 64B is a side view, and FIG. 64C is another side view of the upper housing portion of the connector of FIG. 63. [Figure 67] 64A and 64B are top and bottom views of the upper housing portion of the connector of FIG. 63. [Figure 68] 64A is a perspective view of another embodiment of the upper housing portion of the connector of FIG. 63; and FIG. 64B is a perspective view of the upper housing portion of FIG. 63 assembled to an outer sleeve. [Figure 69] 64A is a perspective view, FIG. 64B is a front view, and FIG. 64C is a side view of the lower housing portion of the connector of FIG. 63. [Figure 70] 64A and 64B are top and bottom views of the lower housing portion of the connector of FIG. 63. [Figure 71] 64A is a perspective view of another embodiment of the lower housing portion of the connector of FIG. 63; and FIG. 64B is a perspective view of the lower housing portion of FIG. 63 assembled to an outer sleeve. [Figure 72] 64A is a perspective view, FIG. 64B is a side view, and FIG. 64C is another side view of the collar of the connector of FIG. 63. [Figure 73] 64A and 64B are (a) a side view and (b) a perspective view of another embodiment of the hollow needle and collar of the connector of FIG. 63. [Figure 74] 64A is a perspective view of a first gaiter of the connector of FIG. 63, and FIG. 64B is a perspective view of a second gaiter of the connector of FIG. 63. [Figure 75] 64A-64C are (a) perspective, (b) front, and (c) rear views of a clip portion of a sterile seal system for use in the connector of FIG. 63. [Figure 76]76A and 76B are top and bottom views of the clip portion of FIG. 75. [Figure 77] 76A and 76B are perspective and bottom views, respectively, of another embodiment of the clip portion of FIG. 75 (a) and (b) of the clip portion of (a) assembled to an outer sleeve; [Figure 78] 64A-64C are (a) perspective, (b) top, and (c) bottom views of a transit cover for use in the connector of FIG. 63. [Figure 79(a)] FIG. 64 is a perspective view of the first step (a) of assembling the connector of FIG. 63. [Figure 79(b)] FIG. 64 is a perspective view of the second step (a) of assembling the connector of FIG. 63. [Figure 79(c)] FIG. 64 is a perspective view of the third step (a) of assembling the connector of FIG. 63. [Fig. 79(d)] FIG. 64 is a perspective view of the fourth step (a) of assembling the connector of FIG. 63. [Figure 79(e)] FIG. 64 is a perspective view of (a) the fifth step in assembling the connector of FIG. 63. [Fig. 79(f)] FIG. 64 is a perspective view of (a) the sixth step of assembling the connector of FIG. 63. [Figure 79(g)] FIG. 64 is a perspective view of the seventh step (a) of assembling the connector of FIG. 63. [Figure 79(h)] FIG. 64 is a perspective view of the eighth step (a) of assembling the connector of FIG. 63. [Figure 79(i)] FIG. 64 is a perspective view of the ninth step (a) of assembling the connector of FIG. 63. [Figure 79(j)] FIG. 64 is a perspective view of the tenth step (a) of assembling the connector of FIG. 63. [Figure 80] FIG. 64 is a perspective view of an embodiment of an interface plate positioned to be sterilely connected to the connector of FIG. 63. DETAILED DESCRIPTION OF THE INVENTION

[0267] The exemplary embodiments described relate to connectors for introducing materials into or extracting materials from at least one receptacle. In particular, some embodiments relate to connectors that are aseptic connectors. It is noted that the terms "aseptic" and "sterile" may be used interchangeably throughout. References to fluids in the detailed description are not intended to limit the scope of protection for such materials. As will be recognized by those skilled in the art, fluids as described herein are merely examples of materials suitable for use with the described connectors. Similarly, references may be made to containers, vacutainers, and the like, but such references in the detailed description are not intended to limit the scope of protection to such receptacles or vessels. As will be recognized by those skilled in the art, containers, vacutainers, and the like are described herein as merely examples of suitable receptacles.

[0268] Certain terminology is used in the following description for convenience only and not as a limitation. The terms "upper" and "lower" designate directions within the referenced drawings and relate to the described components when assembled and mounted. The terms "inner" and "inwardly," and "outer" and "outwardly," refer to directions toward and away from a designated centerline or geometric center (e.g., a central axis) of the described element, respectively, with the particular meaning being readily apparent from the context of the description. Additionally, the terms "proximal" (i.e., nearer to) and "distal" (i.e., away from) designate positions relative to an axis or point of attachment.

[0269] Furthermore, as used herein, terms such as "connected," "affixed," and "coupled" are intended to include a direct connection between two members, without any other members intervening between them, as well as an indirect connection between members where one or more other members are intervening between them. The terminology includes the words and phrases specifically mentioned above, derivatives thereof, and words of similar import.

[0270] Furthermore, unless otherwise specified, the use of ordinal adjectives (e.g., "first," "second," "third," etc.) merely indicates that different instances of similar objects are being referred to and is not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, sequentially, or in any other manner. Like reference numerals are used throughout to indicate like features.

[0271] As shown in Figures 1 and 2, a connector 100 for connecting two volumes of fluid is provided. The connector 100 includes a housing 102, which includes an upper housing portion 102a and a lower housing portion 102b. The housing 102 extends along a longitudinal axis between a distal end 104 and a proximal end 106. The upper housing portion 102a may be axially movable (or slidable) relative to the lower housing portion 102b, as will be further described below.

[0272] Housing 102 includes a threaded portion 107 at its distal end 104 for connection to a corresponding threaded portion 208 of a first container 200 containing a first volume of fluid 202 (see FIGS. 3 and 5 ). As will be apparent to one skilled in the art, housing 102 may be provided without threaded portion 107 and may instead be provided with another suitable connection mechanism for connecting to a portion of the container. Furthermore, the first container may be attached directly to distal end 104 by any suitable mechanism; for example, the container may be pre-connected or sealed, for example, via an adhesive or the like. In some embodiments, the container is manufactured including a connector according to the present invention.

[0273] In this embodiment, the connector 100 includes a first septum seal 108 disposed at the distal end 104 of the housing 102 and a second septum seal 110 disposed at the proximal end 106 of the housing 102. The first septum seal 108 includes a substantially planar (i.e., flat) pierceable surface facing outward at the distal end 104. The second septum seal 110 includes a generally annular portion that extends outward at the proximal end 106 and surrounds the substantially planar (i.e., flat) pierceable surface facing outward at the proximal end 106. The housing 102 further includes a hollow needle 112 that is bias-mounted within the housing 102. The hollow needle 112 is generally coaxially aligned with the longitudinal axis. Hollow needle 112 includes a first end 114 (facing first septum seal 108) and a second end 116 (facing second septum seal 110). First end 114 is configured to be capable of piercing first septum seal 108 in use, and second end 116 is configured to be capable of piercing second septum seal 110 in use. First septum seal 108, second septum seal 110, or both first and second septum seals 108, 110 may optionally be provided with a removable sterile paper seal 111.

[0274] The hollow needle 112 is mounted within the housing 102 through a collar 118, which is spring-biased by a first helical spring 120 and a second helical spring 122. In other embodiments, the hollow needle 112 may be mounted in another suitable manner; for example, the hollow needle 112 may be statically mounted (i.e., it does not move) and the housing 102 may be movable about the hollow needle 112. With further reference to FIG. 3 , the collar 118 includes an upper surface 124 and a lower surface 128, where the upper surface 124 faces an inner surface 126 of the distal end 104 of the housing 102 and the lower surface 128 faces an inner surface 130 of the proximal end 106 of the housing 102. The collar 118 engages with the hollow needle 112 through any suitable engagement mechanism (e.g., a friction-fit throughbore as shown). The first spring 120 extends from an inner surface 126 of the distal end 104 of the housing 102 to an upper surface 124 of the collar 118. The second spring 122 extends from an inner surface 130 of the proximal end 106 of the housing 102 to a lower surface 128 of the collar 118. Thus, the first spring 120 provides a first biasing force F1 on the hollow needle 112 via the collar 118 in a direction toward the proximal end 106 of the housing 102, and the second spring 122 provides a second biasing force F2 on the hollow needle 112 via the collar 118 in a direction toward the distal end 104 of the housing 102.

[0275] As best shown in FIG. 3 , the first helical spring 120 includes a wire diameter (i.e., the thickness of the material from which the helical spring is formed) that is larger than the wire diameter of the second helical spring 122. As such, the first spring 120 exerts a greater biasing force than the second spring 122. That is, the first biasing force F1 is greater than the second biasing force F2. In other examples, the first spring 120 can have an outer diameter (i.e., the diameter of the spring itself) that is larger than the outer diameter of the second spring 122, thereby providing a first biasing force F1 that is greater than the second biasing force F2. Alternatively, in other embodiments, the first spring 120 and the second spring 122 can have equal biasing forces, or the second spring 122 can have a greater biasing force than the first spring 120. In instances where one of the first and second biasing forces is greater than the other (i.e., unequal), hollow needle 112 is caused to first pierce one of first septum seal 108 and second septum seal 110 and then pierce the other of first septum seal 108 and second septum seal 110. In this manner, the unequal first and second biasing forces provide for sequential piercing of the septa, as described in more detail below.

[0276] As will be appreciated by those skilled in the art, other suitable biasing mechanisms may also be used. In some examples, one or both helical springs 120, 122 may be elastic or non-elastic. In other examples, a deformable material or another type of spring may be provided in place of one or both helical springs 120, 122 (e.g., an elastomeric material). The or each deformable material may be provided in the form of a bellows. The or each deformable material may be elastic or non-elastic. Any combination may also be used.

[0277] 1-3 , the connector 100 further includes an actuation mechanism 132 for causing the hollow needle 112 to pierce the septum seals 108, 110. The actuation mechanism 132 includes an outer sleeve 134 that is positioned to collapse the upper housing portion 102a relative to the lower housing portion 102b. The outer sleeve 134 is rotatable relative to the housing 102 about a central longitudinal axis of the housing 102. More specifically, the outer sleeve 134 includes a rail 136 that is positioned to engage with a protrusion (not shown) on the upper housing portion 102a. When the outer sleeve 134 is rotated, the protrusion is guided by the rail 136, thereby translating the rotation of the outer sleeve 134 into axial translation (i.e., collapsing) of the upper housing portion 102a. As described further below, this causes the springs 120, 122 to compress, causing the hollow needle 112 to pierce the septum seals 108, 110. The outer sleeve 134 can also include a circumferential groove 138 at its proximal end. The circumferential groove 138 is configured to receive one or more protrusions 310 on one or more legs 308 of the second container 300 to provide a releasable locking engagement with the second container, as described below. The circumferential groove 138 can receive the one or more protrusions 310 via a snap mechanism. The outer sleeve 134 can also include one or more apertures 140 that allow a user to release the or each leg 308 of the second container 300, thereby releasing the releasable locking engagement.

[0278] With reference to Figures 1 through 11 (particularly Figures 3 through 11), a method of using connector 100 will now be described. Connector 100 is initially coupled to a first container 200 containing a first volume of fluid 202 and a septum seal 204. Septum seal 204 can include a central frusto-conical recess 206. First container 200 can take the form of a bellows, which is a container having a distal end, a proximal end, and a wavy (or Z-folded) wall therebetween. In other examples, first container 200 can take the form of a vacutainer or lid (i.e., an interface plate between connector 100, first container 200, and another container).

[0279] The first container 200 can be removably or permanently coupled to the distal end 104 of the connector 100. In the example shown, the first container 200 includes a threaded portion 208 that threadingly engages with the threaded portion 107 at the distal end 104 of the housing 102 of the connector 100. In this manner, the septum seal 204 of the first container 200 abuts the first septum seal 108 of the connector. In some examples, the first container 200 can include a removable sterile paper seal (not shown) disposed over the septum seal 204, which is arranged to engage with a removable sterile paper seal (not shown) disposed over the first septum 108 of the connector. In such an example, once the connection between the connector 100 and the second container 200 has been made, the sterile paper seals may be removed by pulling the pull tab on each of the respective sterile paper seals, thereby providing a sterile abutment between the septum seal 204 of the first container 200 and the first septum seal 108 of the connector.

[0280] Once the connector 100 is coupled to the first container 200, the connector 100 can then be connected to a second container 300 containing a second volume of fluid 302. The second container 300 can take the form of a container or bellows as described above, or a lid (i.e., an interface plate between the connector 100, the first container 200, or another container), etc. In the example shown, the second container 300 takes the form of a lid that is connected or connectable to a container (e.g., a bioreactor (not shown)). The second container 300 includes a septum seal 304 having a removable sterile paper seal 306 disposed thereon. Additionally, the second container 300 includes a plurality of legs 308, each having a protrusion 310.

[0281] The connector 100 is removably coupled to the second container 300 by snapping the protrusions 310 on each leg 308 into the circumferential groove 138 of the outer sleeve 134. One or more of the legs 308 are exposed through apertures 140 in the outer sleeve 134, thereby allowing the protrusions 310 to be released from the circumferential groove 138 after use. During removably coupling between the second container 300 and the connector 100, the removable sterile paper seal 111 of the connector 100 engages with the removable sterile paper seal 306 of the second container 300. Once the second container 300 is engaged with the outer sleeve 134, the removable sterile paper seals 111, 306 are removed by pulling the pull tabs (or handles) of the respective sterile paper seals 111, 306. In this manner, a sterile abutment is provided between the second septum seal 110 of the connector 100 and the septum seal 304 of the second container 300, as shown in Figure 6. The connector 100 is then ready to provide fluid communication between the first volume of fluid 202 and the second volume of fluid 302.

[0282] 8-11 , the outer sleeve 134 of the connector 100 is rotated about the longitudinal axis of the housing 102. The rotation of the outer sleeve 134 causes the upper housing portion 102a to axially collapse toward (and into) the lower housing portion 102b. In this manner, the hollow needle 112 is caused to pierce the second septum seal 110 first because the biasing force of the first spring 120 is greater than the biasing force of the second spring 122. In other words, the second spring 122 is compressed to a greater extent (or more easily) than the first spring 120, thus allowing the hollow needle 112 to initially pierce the second septum seal 110 of the connector 100. Continued rotation of outer sleeve 134 causes second end 116 of hollow needle 112 to pierce second septum seal 110 of connector 100 and pass into and through septum seal 304 of second container 300. In this manner, second end 116 of hollow needle 112 is fluidly connected to second container 300.

[0283] As the outer sleeve 134 of the connector 100 is continuously rotated about the longitudinal axis of the housing 102, the first spring 120 is caused to compress, causing the hollow needle 112 to pierce the first septum seal 108. In other words, as the first spring 120 is forced to compress, the first end 114 of the hollow needle 112 is forced through the first septum seal 108 because the second spring 122 is already fully compressed due to the different biasing forces. The continued rotation of the outer sleeve 134 causes the first end 114 of the hollow needle 112 to pierce the first septum seal 108 of the connector 100 and enter and then pass through the septum seal 204 of the first container 200. In this manner, the first end 114 of the hollow needle 112 is fluidly connected to the first container 200, thereby fluidly connecting the first container 200 (containing a first volume of fluid 202) to the second container 300 (containing a second volume of fluid 302).

[0284] The fluid in the first volume of fluid 202 may then be introduced into the second volume of fluid 302. Additionally or alternatively, the fluid in the second volume of fluid 302 may then be introduced into the first volume of fluid 202.

[0285] In other examples where the second biasing force F2 of the second spring 122 is greater than the first biasing force F1 of the first spring 120, the septa 108, 110 are pierced sequentially in the reverse order, i.e., the first septum 108 is pierced first, thus fluidly connecting the first container 200, followed by piercing the second septum 110, thus fluidly connecting the second container 300.

[0286] To remove the fluid connection between the two fluid volumes, the method is followed in reverse: outer sleeve 134 is rotated in the opposite direction so that hollow needle 112 is first retracted from first container 200 and first septum seal 114, and then from second container 300 and second septum seal 116, as shown in FIG. 11 . Connector 100 can then be removed by depressing legs 308 to remove protrusion 310 from circumferential groove 138 of outer sleeve 134.

[0287] As shown in Figures 12 through 18, another embodiment of a connector 400 for fluidly connecting two volumes of fluid is provided. Connector 400 is particularly suitable for rapid sampling of a predetermined volume of fluid. Connector 400 is similar in construction to connector 100, except for the details listed below. Like reference numbers indicate like features.

[0288] Connector 400 includes a housing 102 and does not include an outer sleeve 134 as described in connection with first connector 100. However, in some examples, outer sleeve 134 may be present, or that element may be formed as part of the outer surface of housing 102.

[0289] The housing 102 additionally includes an axially movable cap 402 at the distal end 104 of the housing 102. The cap 402 serves to maintain a sterile environment within the housing 102. The cap 402 can include a pierceable, breakable, or septum seal (not shown), which allows the hollow needle 112 to pierce therethrough while maintaining the sterile environment. The cap 402 is axially movable along the longitudinal axis of the connector 400, i.e., it can be foldable or slidable relative to the housing 102.

[0290] Connector 400 is used in a manner similar to that described in connection with connector 100. Initially, connector 400 is connected to a first container 500 (shown in this embodiment as a vacutainer) having a first volume of fluid 502. First container 500 includes a threaded outer sleeve 504 and a septum seal 506. First container 500 is inserted into cap 402, and threaded outer sleeve 504 is threadably engaged with threaded portion 107 of housing 102.

[0291] When first container 500 is connected at its distal end 104 to connector 400, connector 400 is connected at its proximal end 106 to second container 600. In the embodiment shown, second container 600 is a lid that is connected to or connectable to a bioreactor (not shown) and has a second volume of fluid 602 and a septum seal 604. Connector 400 and second container 600 may be connected in any suitable manner, including the manner described above in connection with connector 100 and second container 300.

[0292] 14, once the connector 400, first container 500, and second container 600 are connected, the first container 500 is axially moved (i.e., pushed) toward the second container 600. Thus, as described above, the hollow needle 112 first pierces the second septum seal 110 of the housing 102 and the septum seal 604 of the second container 600, as shown in FIG. 15. Thus, the second end 116 of the hollow needle 102 is fluidly connected to the second volume of fluid 602.

[0293] As the first container 500 is continually pushed toward the second container 600, the hollow needle 112 is caused to pierce the septum seal of the cap 402 and the septum seal 506 of the first container 500, as shown in FIG. 16. In doing so, the first end 114 of the hollow needle 102 becomes fluidly connected to the first volume of fluid 502, thereby fluidly connecting the first volume of fluid 502 to the second volume of fluid 602.

[0294] Once the operation is complete, and as shown in Figures 17 and 18, the user stops applying pressure to the first container 500, i.e., stops pushing on the first container 500, so that the connector 400 can be removed from the second container 600.

[0295] Additionally or alternatively, in some examples, the connector 400 may be disengaged from the connection mechanism on the second container 600. The first container 500 may then be removed from the connector 400 by unscrewing the threaded outer sleeve 504 of the first container from the connector 400.

[0296] While the embodiment of Figures 12-18 utilizes two springs as part of the actuation mechanism, it will be apparent to one skilled in the art that such actuation mechanism may be replaced by any of the other actuation mechanisms discussed herein, particularly those discussed in the embodiments described below.

[0297] As shown in Figures 19 through 27, another embodiment of a connector 700 for connecting two volumes of fluid is provided. Connector 700 is of the same construction as connector 100 described in connection with Figures 1 through 11, except for the details listed below. Like reference numbers indicate like features.

[0298] Connector 700 includes a lower housing portion 102b (as best shown in FIGS. 21(a) to 21(e)) and an upper housing portion 102a (as best shown in FIGS. 22(a) to 22(e)) surrounded by an outer sleeve 134 (as best shown in FIGS. 23(a) to 23(e)).

[0299] 19, the outer sleeve 134 of the connector 700 includes a plurality of tines 702 that are recessed into the outer surface of the outer sleeve 134. The tines 702 are configured and arranged to engage cooperating features of an automated actuation mechanism formed as part of an instrument (not shown). In this manner, the outer sleeve 134 can be automatically actuated (i.e., rotated) by an actuation mechanism such as an instrument or incubator.

[0300] 21(a) through 21(e) and with further reference to FIGS. 22(a) through 22(e), the lower housing portion 102b includes an inner body portion that is concentrically displaced within and attached to the outer body portion. The inner body portion and the outer body portion are generally of equal height. Furthermore, the lower housing portion 102b includes a plurality of arms 704, each extending axially from an upper (or distal) portion of the lower housing portion 102b. Furthermore, each arm 704 is provided with a hook portion 706 at its distal end. The arms 704 may be elastically deformable or otherwise flexible. The lower housing portion 102b is also provided with a plurality of outwardly angled tongues 708, which are angled outward relative to the central longitudinal axis and are optionally formed within cutouts in the outer body portion of the lower housing portion 102b. The tongues 708 may be elastically deformable or otherwise flexible. The tongues 708 are positioned at their distal ends to engage the bottom edge of the upper housing portion 102a, preventing the upper housing portion 102a from being disposed over the lower housing portion 102b. In this manner, the tongues 708 are configured as a needle safety feature, allowing the upper housing portion 102a to be disposed over the lower housing portion 102b only when desired and intended. Accidental axial translation of the upper housing portion 102a relative to the lower housing portion 102b is therefore mitigated. Notably, in use, upper housing portion 102a is placed over lower housing portion 102b. A bottom edge of upper housing portion 102a engages tongue 708. To allow upper housing portion 102a to be disposed over lower housing portion 102b, tongue 708 must be pushed inward by an actuation mechanism or by a user. In some examples, tongue 708 may be pushed inward by one or more pins of an actuation mechanism (not shown).In contrast, when removing the upper housing portion 102a from the lower housing portion 102b, the upper housing portion 102a is removed axially and the tongue 708 returns to its original position due to its elastically deformable nature.

[0301] Lower housing portion 102b also includes a circumferential skirt 710 having a plurality of slots 712 thereby defining a plurality of resiliently deformable portions 714 of circumferential skirt 710. Each resiliently deformable portion 714 includes an outwardly (or radially) extending ledge portion 716 that is configured and arranged to engage, in use, with a circumferential groove 138 of outer sleeve 134 of connector 700 (see FIG. 20 ), thereby forming a snap-fit ​​arrangement. Circumferential skirt 710 may be interrupted by an opening configured and arranged to receive a sterile sealing system, as described further below.

[0302] Referring to FIGS. 22(a) through 22(e), the upper housing portion 102a includes a plurality of windows 720 configured and arranged to receive an arm 704 and its hook portion 706 (see FIGS. 21(a) through 21(e)) therethrough during use. The hook portion 706 (see FIGS. 21(a) through 21(e)) is configured and arranged to retain the lower housing portion 102b to the upper housing portion 102a and prevent its accidental release. Therefore, needlestick injuries and connector malfunctions can be prevented. In other words, the arm 704 extending through the window 720 must be compressed to release the upper housing portion 102a from the lower housing portion 102b. Therefore, rapid and needle-safe assembly and disassembly of the connector can be achieved.

[0303] Additionally, the upper housing portion 102a also includes a plurality of protrusions formed as circular studs 722 extending radially outward from the body of the upper housing portion 102a and configured and arranged to cooperate with the rails 136 of the outer sleeve 134 in the same manner as described in the above embodiment of Figures 1-11. Slots 724 are also provided, formed in the body of the upper housing portion 102a and extending axially downward from each of the studs 722 toward the bottom edge of the upper housing portion 102a. The slots 724 are configured and arranged to allow one or more pins (or similar features) of an actuation mechanism (not shown) to protrude therethrough and engage with and / or protrude through the needle safety feature (i.e., tongue 708) of Figures 21(a)-21(e) as described above. As such, when assembled, slot 724 is aligned with tongue 708 in Figures 21(a) to 21(e) to allow space for one or more pins of an actuation mechanism (not shown) to protrude.

[0304] 19, 20, and 24(a)-24(e), connector 700 is provided with a sterile seal system 730 that is configured and arranged to mate with a corresponding sterile seal system (not shown) on another component (e.g., a receptacle or interface, etc.). Sterile seal system 730 is provided with a clip portion 732 and a sterile membrane 734, with clip portion 732 preferably constructed from high-density polyethylene (HDPE) and configured and arranged to clip onto outer sleeve 134 of connector 700 in use. Clip portion 732 is provided with a pair of substantially parallel lateral rails 735 that have an upstanding wall 736 at one end and an aperture 738 at another end.

[0305] Upstanding wall 736 is provided with a protrusion 740 extending radially outward. Referring particularly to FIGS. 19 and 20 , rail 735 is constructed and arranged to be slidably received within a corresponding portion of outer sleeve 134 and removably coupled to circumferential groove 138 thereof by protrusion 740. Sterile seal system 730 is also arranged to be received within a space in lower housing portion 102b, as described above. Thus, when received within lower housing portion 102b, in use, protrusion 740 and upstanding wall 736 complete circumferential skirt 710 (see FIGS. 21(a) to 21(e)) of lower housing portion 102b. In use, when sterile seal system 730 is removed from connector 700, upstanding wall 736 may be caused to break, i.e., upstanding wall 736 may be frangible. This facilitates the single-use nature of the sterile seal system 730. Alternatively, the upstanding wall 736 may be released from the outer sleeve 134 prior to removal.

[0306] Aperture 738 is constructed and arranged to receive a corresponding protrusion formed as part of an actuation system (not shown) for coupling to the actuation system such that, upon actuation, the protrusion engages aperture 738 to slidably remove clip portion 732 and associated sterile membrane 734.

[0307] Sterile membrane 734 may be formed as a sterile paper seal, polyethylene film, or the like, and is typically coupled to clip portion 732. Sterile membrane 734 includes at least one fold 742. At least one fold 742 forms a sterile surface 744 and a mating surface 746. Sterile surface 744 is positioned to aseptically seal (i.e., cover) second septum seal 110 (see FIG. 2) in use. Mating surface 746 is positioned to cooperate and mate with a corresponding mating surface (not shown) of a corresponding sterile seal system (not shown). Mating surface 746 may be heat welded, glued, or the like to the corresponding mating surface.

[0308] 25(a) through 25(e), the collar 118 of the connector 700 is shown in greater detail. The collar 118 is configured to engage the hollow needle 112 via a friction fit. As can be seen in FIGS. 20 and 25(d), the collar 118 is positioned off-center, either toward the second end 116 of the hollow needle 112 or away from the first end 114 of the hollow needle 112.

[0309] 20 and 26(a) through 26(e), connector 700 further includes a flexible gaiter 760, which is generally formed as a cylindrical sleeve. Flexible gaiter 760 is coupled at a distal end 762 to upper housing portion 102a and at a proximal end 764 to lower housing portion 102b. Gaiter 760 is flexible to allow for axial displacement between upper and lower housing portions 102a, 102b during use. Gaiter 760 may be coupled at its distal and proximal ends 762, 764 by any suitable means (e.g., by welding, adhesive, clips, or the like).

[0310] 19 through 26, and particularly with reference to FIGS. 27(a) through 27(e), connector 700 is shown in use. In FIG. 27(a), connector 700 is coupled at its distal end 104 and proximal end 106 to respective volumes of fluid (not shown). A sterile membrane 734 of sterile seal system 730 is coupled adjacent proximal end 106 to a corresponding sterile membrane on one of the volumes of fluid (not shown). The sterile seal system 730, coupled to a corresponding sterile seal system (not shown), is then removed by an actuation device, preferably through slidably removing (i.e., pulling) clip portion 732 of sterile seal system 730. In some examples, the actuation device can include a protrusion that is received in an aperture 738 of clip portion 732. The act of slidably removing sterile membrane 734 allows for sterile, face-to-face engagement of second septum seal 110 of connector 700 with a corresponding septum seal of a predetermined volume of fluid. In some examples (such as the example shown), sterile seal system 730 remains in place and hollow needle 112 is positioned to pierce through sterile membrane 734.

[0311] As shown in FIG. 27(b), the connector 700 is preferably actuated through a toothed actuation mechanism that engages a plurality of teeth 702 on the outer sleeve 134 of the connector 700 to rotate the outer sleeve 134. As shown in FIGS. 27(b) and 27(c), continued rotation of the outer sleeve 134 provides sequential piercing of the first and second septum seals 108, 110, as described above, providing a sterile fluid pathway between the two volumes of fluid. Then, as shown in FIGS. 27(d) and 27(e), the actuation mechanism counter-rotates the outer sleeve 134 via the teeth 702, sequentially aseptically disconnecting the hollow needle 112 from the first and second septum seals 108, 110, thereby aseptically disconnecting the volumes of fluid. The connector 700 can then be removed and discarded.

[0312] As shown in Figures 28-30, another embodiment of a connector 800 for connecting two volumes of fluid is provided. Connector 800 is of the same construction as connector 100 described in connection with Figures 1-11, except for the details listed below. Like reference numbers indicate like features.

[0313] As best shown in FIG. 29 , connector 800 includes a single helical spring 802 received between collar 118 and upper housing portion 102a. Specifically, single helical spring 802 extends from inner surface 126 of distal end 104 of housing 102 (i.e., inner surface 126 of upper housing portion 102a) to upper surface 124 of collar 118. In other embodiments, single helical spring 802 may be received between collar 118 and lower housing portion 102b. In those embodiments, single helical spring 802 would extend from inner surface 130 of proximal end 106 of housing 102 (i.e., inner surface 130 of lower housing portion 102b) to lower surface 128 of collar 118. In those embodiments, sequential drilling would be accomplished in the reverse order from that described below.

[0314] 28 and 29, the upper housing portion 102a of the connector 800 includes a pair of actuatable lugs 804a, 804b. The actuatable lugs 804a, 804b are shown as generally cylindrical protrusions extending radially from the outer surface of the upper housing portion 102a. The actuatable lugs 804a, 804b can be of any size or shape. The outer sleeve 134 of the connector 800 includes a pair of longitudinal slots 806, each configured and arranged to receive one of the actuatable lugs 804a, 804b. The actuatable lugs 804a, 804b are axially movable and guided by the longitudinal slots 806 to permit axial translation (i.e., folding) of the upper housing portion 102a relative to the lower housing portion 102b, as described further below. In other examples, actuatable lugs may be formed on lower housing portion 102b to achieve sequential drilling in the reverse order to that described below.

[0315] The connector 800 further includes a sterile seal system 730, as described above in connection with Figures 19, 20 and 24(a) through 24(e).

[0316] 30(a) through 30(e), connector 800 is shown in use. In FIG. 30(a), connector 800 is coupled to respective volumes of fluid at its distal end 104 and proximal end 106. A sterile membrane 734 of sterile seal system 730 is coupled to a corresponding sterile membrane on one of the volumes of fluid (not shown) adjacent proximal end 106. Sterile seal system 730, coupled to a corresponding sterile seal system (not shown), is then removed by an actuation device, preferably through slidably removing (i.e., pulling) clip portion 732 of sterile seal system 730. In some examples, the actuation device can include a protrusion that is received in an aperture 738 of clip portion 732. The act of slidably removing sterile membrane 734 allows for sterile, face-to-face engagement of second septum seal 110 of connector 800 with a corresponding septum seal of the receptacle. In some instances (such as the example shown), sterile seal system 730 remains in place and hollow needle 112 is positioned to pierce through sterile membrane 734.

[0317] As shown in FIG. 30(b), the connector 800 is preferably actuated through an axially translatable actuation mechanism that engages the distal end 104 of the connector 800 to axially translate (i.e., push or fold) the upper housing portion 102a relative to the lower housing portion 102b. Alternatively, the actuation mechanism can engage a pair of actuable lugs 804a, 804b (see FIG. 28) to axially translate the upper housing portion 102a. The actuation mechanism may be formed as part of the instrument (e.g., an incubator, etc.). As can be seen in FIG. 30(b), when the upper housing portion 102a folds relative to the lower housing portion 102b, the collar 118 (and thus the hollow needle 112 operably coupled thereto) is axially translated toward the second septum seal 110 at the proximal end 106 of the connector 800. Spring 802 remains in its original configuration during this initial actuation step due to the biasing force exerted on collar 118. Such axial translation therefore causes hollow needle 112 to pierce second septum seal 110 at its second end 116.

[0318] 30(c), continued axial translation of upper housing portion 102a causes compression of spring 802, allowing upper housing portion 102a to further collapse, thus causing hollow needle 112 to pierce first septum seal 108 at its first end 114. Thus, the volumes of fluid connected at each end of connector 800 are fluidly connected by hollow needle 112.

[0319] As shown in FIG. 30(d), upper housing portion 102a is allowed to relax, or upper housing portion 102a is axially translated toward distal end 104 of connector 800 (i.e., away from proximal end 106 of connector 800) through the biasing force of spring 802. In this manner, hollow needle 112 stops piercing first septum seal 108 at its first end 114. Further axial translation of upper housing portion 102a toward distal end 104 of connector 800, shown in FIG. 30(e), causes hollow needle 112 to stop piercing second septum seal 110 at its second end 116. Thus, aseptic disconnection is achieved. Connector 800 can be removed and discarded.

[0320] As shown in Figures 31 through 35, another embodiment of a connector 900 for connecting two volumes of fluid is provided. Connector 900 is of the same construction as connector 100 described in connection with Figures 1 through 11, except for the details listed below. Like reference numbers indicate like features.

[0321] 31-33 , unlike the previous embodiment, the connector 900 of this embodiment does not include a spring. Instead, the connector 900 is provided with a collar 118 that includes a plurality of actuatable lugs 902 extending radially outward from the collar 118. The actuatable lugs 902 can be any size or shape. Additionally, the upper housing portion 102a includes a plurality of actuatable lugs 904 extending radially outward from the upper housing portion 102a. Similarly, the actuatable lugs can be any size or shape.

[0322] The outer sleeve 134 of the connector 900 includes two half-pipe sections 134a, 134b, which may be welded, glued, clipped, or the like to secure the two half-pipe sections 134a, 134b together during use. Alternatively, the outer sleeve 134 may be integrally formed. The outer sleeve 134 generally includes a first plurality of longitudinal slots 906 and a second plurality of longitudinal slots 908. As shown in FIG. 31 , each of the plurality of actuatable lugs 902 of the collar 118 extends radially outward through each of the first plurality of longitudinal slots 906, and each of the plurality of actuatable lugs 904 of the upper housing portion 102a extends radially outward through each of the second plurality of longitudinal slots 908. 31 , the lower stops of the first plurality of longitudinal slots 906 and the lower stops of the second plurality of longitudinal slots 908 are coplanar, i.e., they are formed at substantially similar or the same distance from the proximal end 106 of the connector 900. The upper stops of the first plurality of longitudinal slots 906 and the upper stops of the second plurality of longitudinal slots 908 are non-coplanar, i.e., they are formed at substantially different distances from the proximal end 106 of the connector 900.

[0323] As best shown in FIG. 34 , the plurality of actuatable lugs 902 extending from the collar 118 are offset from each other by approximately 120°. Similarly, the plurality of actuatable lugs 904 extending from the upper housing portion 102a are offset from each other by approximately 120°. The slots of the first plurality of longitudinal slots 906 and the slots of the second plurality of longitudinal slots 908 are similarly offset from each other by 120° relative to the others of the plurality of slots. Generally, as shown in FIG. 34 , the actuatable lugs 902 of the collar 118 and the actuatable lugs 904 of the upper housing portion 102a are offset from each other. Similarly, the first and second pluralities of longitudinal slots 906, 908 are offset from each other.

[0324] 31-34, connector 900 is further provided with sterile seal system 730, as described above in connection with Figures 19, 20, and 24(a)-24(e). However, as best shown in Figure 33, sterile seal system 730 does not include a protruding portion for clipping onto the outer sleeve of connector 900. Thus, sterile seal system 730 is freely slidable relative to the outer sleeve.

[0325] The connector 900 in use is shown in Figures 35(a) through 35(e). In Figure 35(a), the connector 900 is coupled to respective volumes of fluid at its distal end 104 and proximal end 106. The sterile membrane 734 of the sterile seal system 730 is coupled to a corresponding sterile membrane on one of the volumes of fluid adjacent the proximal end 106. The sterile seal system 730, coupled to a corresponding sterile seal system (not shown), is then removed by an actuation device, preferably through slidably removing (i.e., pulling) the clip portion 732 of the sterile seal system 730. In some examples, the actuation device can include a protrusion that is received in an aperture 738 of the clip portion 732. The act of slidably removing the sterile membrane 734 enables sterile, face-to-face engagement of the second septum seal 110 of the connector 900 with the corresponding septum seal of the predetermined volume of fluid. In some instances (such as the example shown), the sterile seal system 730 remains in place and the hollow needle 112 is positioned to pierce through the sterile membrane 734 .

[0326] As shown in FIG. 35(b), the connector 900 is preferably actuated through an axially translatable actuation mechanism that engages an actuable lug 904 extending from the upper housing portion 102a of the connector 900 to axially translate (i.e., push or fold) the upper housing portion 102a relative to the lower housing portion 102b. Simultaneously, the axially translatable actuation mechanism engages an actuable lug 902 extending from the collar 118 of the connector 900 to axially translate (i.e., push) the collar 118 (and thus the hollow needle 112) toward the second septum seal 110. Thus, the second end 116 of the hollow needle 112 is caused to pierce the second septum seal 110. The actuation mechanism may be formed as part of an instrument (e.g., an incubator, etc.).

[0327] As shown in FIG. 35(c), the axially translatable actuation mechanism (engaged with actuatable lug 904 extending from upper housing portion 102a) continues to axially translate upper housing portion 102a toward proximal end 106 of connector 900. Simultaneously, the axially translatable actuation mechanism (engaged with actuatable lug 902 of collar 118) holds collar 118 in place during further actuation of upper housing portion 102a. In this manner, first septum seal 108 is caused to be pierced by first end 114 of hollow needle 112, as shown in FIG. 35(c). A sterile fluid pathway is thus formed between the connected volumes of fluid.

[0328] 35(d), to aseptically disconnect connector 900, upper housing portion 102a is axially translated toward distal end 104 of connector 900 via an axially translatable actuation mechanism engaged with actuatable lug 904 of upper housing portion 102a. In this manner, hollow needle 112 is caused to stop piercing first septum seal 108 at its first end 114.

[0329] 35(e), further axial translation of upper housing portion 102a of connector 900 is provided through an actuation mechanism engaged with actuatable lug 904 of upper housing portion 102a. Simultaneously, collar 118 (and thus hollow needle 112) is axially translated toward distal end 104 of connector 900 via an actuation mechanism engaging actuatable lug 902 of collar 118, causing hollow needle 112 to cease piercing second septum seal 110 at its second end 116. Connector 900 is thus aseptically fluidly disconnected. Connector 900 may be removed and discarded.

[0330] As shown in Figures 36 through 50, another embodiment of a connector 1000 for connecting two volumes of fluid is provided. Connector 1000 is of the same construction as connector 900 described in connection with Figures 31 through 35, except for the details listed below. Like reference numbers indicate like features.

[0331] As best shown in Figures 36-38, connector 1000 is similar in construction to connector 900, except that actuatable lug 902 of collar 118 (operably coupled to hollow needle 112) and actuatable lug 904 of upper housing portion 102a are aligned and therefore axially movable within the same longitudinal slot 1002 of outer sleeve 134 of connector 1000. Additionally, there are three actuatable lugs 902 of collar 118, with the first actuatable lug offset by 90° from the second actuatable lug, which is offset by 90° from the third actuatable lug, which is offset by 180° from the first actuatable lug. The same applies to actuatable lug 904 and longitudinal slot 1002 of upper housing portion 102a. Thus, the actuatable lugs 902, 904 form a generally T-shaped arrangement.

[0332] The lower housing portion 102b of the connector 1000 is shown in more detail in Figures 40(a) through 40(e). In particular, as described elsewhere, the lower housing portion 102b includes a substantially cylindrical outer body portion 1004 and a substantially cylindrical inner body portion 1006. The outer body portion 1004 and the inner body portion 1006 are substantially concentric and spaced apart by an annular space 1008. As described below, the upper housing portion 102a is disposed axially translatably over the outer body portion 1004. The inner body portion 1006 serves to retain the collar 118 (and thus the hollow needle 112). The outer body portion 1004 is provided with a plurality of slots 1010 configured to allow the actuatable lugs 902 (see FIG. 36) of the collar 118 and the actuatable lugs 904 (see FIG. 36) of the upper housing portion 102a to protrude therethrough in use. Similarly, the inner body portion 1006 is provided with a plurality of slots 1012 configured to allow the actuatable lugs 902 (see FIG. 36) of the collar 118 to protrude therethrough in use.

[0333] The upper housing portion 102a of the connector 1000 is shown in more detail in Figures 41(a) through 41(e). Among other things, as described above, the upper housing portion 102a includes a plurality of actuatable lugs 904 extending radially outward from the body portion of the upper housing portion 102a. Additionally, the upper housing portion 102a is provided with a plurality of slots 1014 configured to allow the actuatable lugs 902 (see Figure 36) of the collar 118 to protrude therethrough in use. The upper housing portion 102a further includes a circumferentially protruding flange separating the threaded portion 107 from the remainder of the upper body portion 102a.

[0334] The collar 118 of the connector 1000 is shown in more detail in Figures 42(a) through 42(e). The collar 118 is provided with a plurality of actuatable lugs 902 projecting radially outward from the collar 118, as described above. As described above in connection with other embodiments, the collar 118 includes a substantially cylindrical outer body portion 1016 and a substantially cylindrical inner body portion 1018, with the actuatable lugs 902 projecting from the substantially cylindrical outer body portion 1016, which is configured and arranged to operably engage the hollow needle 112, for example, through a friction fit. In those embodiments in which a spring is utilized, an annular recess 1020 is provided between the inner and outer body portions 1016, 1018, which is configured to receive the spring. As can be seen in Figures 42(a) to 42(e), the collar 118 is positioned off-center on the hollow needle 112 such that the collar 118 is positioned closer to (i.e., more proximal or toward) the second end 116 of the hollow needle 112, or such that the collar 118 is positioned further away from (i.e., more distal or away from) the first end 114 of the hollow needle 112.

[0335] 37 and 43(a) through 43(e), hollow needle 112 is sterilely surrounded by first and second gaiters 1022, 1024. First gaiter 1022 surrounds an upper portion of hollow needle 112 and extends from collar 118 to its first end 114. Second gaiter 1024 surrounds a lower portion of hollow needle 112 and extends from collar 118 to its second end 116. Thus, gaiters 1022, 1024 ensure a sterile environment for hollow needle 112 and also serve to prevent accidental needlestick injuries. Gaiters 1022, 1024 are generally concertina or bellows shaped, i.e., they have multiple Z-folds and are constructed of a flexible (or elastically deformable) material, allowing gaiters 1022, 1024 to fold during use. In some examples, gaiters 1022, 1024 may be independently constructed of low-density polyethylene (LDPE), a thermoplastic elastomer, or the like. First gaiter 1022 is secured at one end to upper housing portion 102a and at its other end to collar 118 via any suitable means, such as gaiter clip 1026 (preferably constructed of high-density polyethylene (HDPE)), adhesive, or heat welding. Second gaiter 1024 is similarly secured at one end to lower housing portion 102b and at its other end to collar 118 via any suitable means, such as gaiter clip 1026 (preferably constructed from high density polyethylene (HDPE)), adhesive, or heat welding.

[0336] The outer sleeve 134 of the connector 1000 is shown in more detail in Figures 44(a) through 44(f). As shown in Figures 44(a) and 44(b), the outer sleeve 134 generally includes two half-pipe sections 134a, 134b that are substantially mirror images of one another. Each half-pipe section 134a, 134b of the outer sleeve 134 includes a sidewall 1032 that terminates at a base 1034. The sidewall 1032 includes a plurality of longitudinal slots 1030, at least a portion of which are constructed and arranged to allow the actuatable lugs 902, 904 to protrude therethrough in use, and which extend axially through the sidewall 1032. The base 1034 further includes a sterile seal system receiving area 1036 configured and arranged to receive a sterile seal system (such as the sterile seal system 730 described above in connection with FIGS. 19, 20, and 24(a)-24(e) and shown in FIGS. 36 and 37). The receiving area 1036 is shaped in a complementary manner to the sterile seal system 730. The receiving area 1036 can include one or more cooperating features (e.g., rail guides, etc.) that cooperate with one or more features (e.g., rails, etc.) of the sterile seal system. The receiving area 1036 can expose a portion (or all) of a second septum seal (not shown) during use. The sidewall 1032 includes one or more longitudinal grooves 1038 that terminate in respective apertures 1040 in the base 1034. The longitudinal groove 1038 and aperture 1040 are configured and arranged to allow one or more pins of an actuation mechanism (not shown) to activate a needle safety feature (i.e., a tongue) in the lower housing portion. Additionally, the longitudinal groove 1038 and aperture 1040 can cooperate with a retention feature (formed as part of the instrument, housing, retention mechanism, or incubator) to limit movement of the connector.

[0337] Figures 45(a) through 45(e) illustrate the upper housing portion 102a, lower housing portion 102b, hollow needle 112, collar 118, and gaiters 1022, 1024 when assembled. As can be seen, actuatable lugs 902, 904 on collar 118 and upper housing portion 102a, respectively, project outwardly through various slots, as described above.

[0338] Figures 46(a) through 46(d) illustrate the assembled components of Figures 45(a) through 45(e), further including the outer sleeve 134 of Figures 44(a) through 44(f) assembled thereto. As can be seen, prior to assembly of the sterile seal system, the second septum seal 110 is exposed in a receiving area 1036 in the base 1034 of the outer sleeve 134. In this particular embodiment, the septum seal 110 is formed as a co-molded material to the lower body portion having an annular raised area defining a flat perforation area therein.

[0339] Figures 47(a) through 47(f) illustrate a sterile sealing system 730 similar to that described above for use with connector 1000. Figure 47(f) illustrates sterile sealing system 730 received within receiving portion 1036 of outer sleeve 134.

[0340] 48(a) through 48(c) illustrate a transit cover 1050 and a transit cap 1060 for use with the connector 1000. The transit cover 1050 includes a hollow body portion that is sized and shaped to be complementary to the connector 1000 so as to receive the connector 1000 therein. The transit cap 1060 is sized and shaped to be complementary to the proximal end 106 of the connector 1000, and specifically is shaped and sized to take into account the shape and size of the sterile seal system 730.

[0341] 49(a) through 49(d), 50(a), and 50(b) illustrate a retention mechanism 1100 for retaining the connector 1000 during use, which is optionally formed as part of an instrument, housing, or incubator. As best shown in FIGS. 49(a) through 49(d), the retention mechanism 1100 includes a generally cylindrical sidewall 1102 terminating in a base 1104. The sidewall 1102 includes a plurality of slots 1106 configured and arranged to receive (or otherwise allow to protrude therethrough) the protruding actuatable lugs 902, 904 of the connector. The base 1104 is configured to allow the connector 1000 to be retained within a cavity formed by the base 1104 and the sidewall 1102. The base 1104 includes a plurality of notches 1108 (or pins, etc.) that extend upright from the base 1104 and are parallel to the sidewall 1102 and are constructed and arranged to engage with and protrude through longitudinal grooves 1038 and apertures 1040 formed in the outer sleeve 134 of the connector 1000. In this manner, the connector 1000 can be easily positioned in the correct position. The notches 1108 each include an enlarged head that is complementary in size and shape to the apertures 1040 of the outer sleeve 134 to prevent movement of the connector 1000 within the retention mechanism 1100 during use. Furthermore, the notch 1108 is adapted to engage and activate the tongue 708 (see FIGS. 21(a) to 21(e)) via the slot 724 (see FIGS. 22(a) to 22(e)) in use, thereby enabling needle-safe activation of the upper and lower housing portions 102a, 102b. The base 1104 further includes a cutout region 1110 that is configured to receive the sterile seal system 730 of the connector 1000.

[0342] 50(a) and 50(b) illustrate the connector 1000 and retention mechanism 1100 in use with an interface plate 1150 and a bioreactor 1160. The interface plate 1150 is formed as a lid for the bellows-based bioreactor 1160. The interface plate 1150 is formed with a plurality of sterile seal systems 1152 that are complementary to the sterile seal systems 730. Among other things, each sterile seal system 1152 includes a protruding portion 1154 that is configured and arranged to couple with a portion of the clip portion 732 (e.g., aperture 738) of the sterile seal system 730 (see also FIGS. 47(a) through 47(f)). Additionally, each sterile seal system includes a sterile membrane 1156 that is configured to couple with the sterile membrane 734 of the sterile seal system 730 (see also FIG. 47(a)). The coupling of the membranes 734, 1156 can be by adhesive or heat welding, etc. Once coupled, an actuation device (not shown) can remove the coupled sterile seal system 730, 1152, thereby exposing the second septum seal 110 to the septum seal 1158 of the interface plate 1150.

[0343] As shown in Figures 51 through 62, another embodiment of a connector 1200 for connecting two volumes of fluid is provided. Connector 1200 is of the same construction as connector 1000 described in connection with Figures 36 through 50, except for the details listed below. Like reference numbers indicate like features.

[0344] Connector 1200 includes a pair of actuatable lugs 902 projecting from collar 118 rather than the three actuatable lugs shown in connector 1000. The pair of actuatable lugs 902 extend in opposite directions relative to one another (180° apart). In other words, the actuatable lugs 902 extend radially outward and are diametrically opposite one another. Similarly, connector 1200 includes a pair of actuatable lugs 904 projecting from upper housing portion 102a rather than the three actuatable lugs shown in connector 1000. The pair of actuatable lugs 904 extend in opposite directions relative to one another (180° apart). In other words, the actuatable lugs 904 extend radially outward and are diametrically opposite one another. Additionally, both pairs of actuatable lugs 902, 904 include a substantially cross-shaped (or cruciform) cross section. These features allow for easy automation of the actuation mechanism.

[0345] The connector 1200 in FIG. 51( a) is shown with a transit cover 1050 and a transit cap 1060, which are complementary to the respective ends of the connector 1200. In particular, the transit cover 1050 serves to cover only the proximal end of the connector 1200, and the transit cap 1060 serves to cover only the distal end of the connector 1200. Thus, a portion of the connector 1200 remains uncovered. In some examples (not shown), the transit cover 1050 and the cap 1060 may be integrally formed to provide a sterile package for the connector 1200, which is packaged within the transit cover 1050 and the cap 1060 in a manner substantially as shown in FIG. 51( a).

[0346] 52(a) and 52(b) illustrate the outer sleeve 134 of the connector 1200. As can be seen, the outer sleeve 134 includes only a pair of opposing longitudinal slots 1030 disposed in a sidewall portion 1032 of the outer sleeve 134. As described above, such slots 1030 are positioned to allow the actuatable lugs 902, 904 to extend (or otherwise protrude) therethrough. The outer sleeve 134 can include two half-pipe sections, as described above, or can be formed as a unitary component. Feature 134c indicates a seam, weld, or the like between adjacent sections. The outer sleeve 134 can be constructed from polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS), or another suitable material.

[0347] Figures 53(a) through 53(c) illustrate another embodiment of a sterile seal system 1250 for a connector 1200. The sterile seal system 1250 includes a clip portion 1252 and a sterile membrane 1254. Similar to the sterile seal system 730 shown in Figures 19, 20, and 24(a) through 24(e), the clip portion 1252 is preferably constructed from high-density polyethylene (HDPE) and is constructed and arranged to clip onto the outer sleeve 134 of the connector 1200 during use. In this particular example, the clip portion 1252 includes a pair of substantially parallel lateral rails 1256 connected to a semicircular wall 1258 and having a shoulder 1259. The clip portion 1252 also includes a protrusion 1260 that protrudes from a base 1262 of the clip portion 1252 and is configured to engage and retain the sterile membrane 1254. For this purpose, the protrusion 1260 may include one or more clips. The lateral rail 1256 is arranged to cooperate with a corresponding rail-receiving portion of the outer sleeve 134 (see FIG. 52(a)). The clip portion 1252 is also provided with a plurality of reinforcing ribs 1263, which extend parallel to the rail 1256.

[0348] Sterile membrane 1254 may be formed as a sterile paper seal, polyethylene film, or the like, and is typically connected to clip portion 1252 by an aperture connected to protrusion 1260 and held in place by one or more clips. Also provided is an affixation location 1265 for affixing sterile membrane 1254 to connector 1200 during use. Attachment location 1265 may cooperate with a corresponding feature on connector 1200 or may serve as a guide for properly positioning sterile membrane 1254 for heat welding, gluing, or the like during use.

[0349] 54(a) and 54(b), clip portion 1252 is slidably disposed within the rail-receiving portion of outer sleeve 134. A semi-circumferential wall 1258 forms the outermost portion of clip portion 1252. Shoulder portion 1259 is positioned and configured to be engaged by a pushing portion of an actuation mechanism to slidably remove clip portion 1252, and thus sterile membrane 1254, from septum seal 110 during use.

[0350] 55(a) through 55(c) illustrate the collar 118 of the connector 1200. The collar 118 is substantially as described above, and further includes a pair of apertures 1270 to allow the passage of air between an upper portion of the collar 118 and a lower portion of the collar 118. In this manner, smooth axial translation of the collar 118 during use is achieved. The collar 118 may preferably be constructed from acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS), polycarbonate, or a similar material. The hollow needle 112 may preferably be constructed from stainless steel.

[0351] Figures 56(a) through 56(c) illustrate first and second gaiters 1022, 1024, substantially as described in connection with Figures 37 and 43(a) through 43(e). The gaiters may be constructed from low-density polyethylene (LDPE), thermoplastic elastomer (TPE), silicone, or similar materials. As described above, the gaiter clips may be constructed from high-density polyethylene (HDPE).

[0352] FIGS. 57(a) through 57(c) illustrate the lower housing portion 102b of the connector 1200. The lower housing portion 102b further includes an access slot 1272, allowing the user to access the second gaiter 1024 during use (see FIG. 60(b)). Additionally, the second septum seal 110 is provided with a raised annular region 1274 that encloses a flat portion 1276 therein for puncturing during use. Also provided are fastening points 1278 for fastening a sterile membrane (not shown) to the lower housing portion 102b (specifically, over the septum seal 110). The lower housing portion 102b may be constructed from polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS), or a similar material. The septum seal 110 may be made of a thermoplastic elastomer (TPE), silicone, or the like.

[0353] FIGS. 58(a) through 58(d) illustrate the upper housing portion 102a of the connector 1200. The upper housing portion 102a further includes an access slot 1280, allowing the user to access the first gaiter 1022 during use (see FIG. 60(b)). Additionally, the protruding circumferential flange of the previous embodiment of the upper housing portion 102a has been replaced by a step 1282. The upper housing portion 102a may be constructed from polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS), or similar materials. The septum seal 108 may be constructed from a thermoplastic elastomer (TPE), silicone, or the like.

[0354] Figures 59-62 illustrate assembly of connector 1200. First, gaiters 1022, 1024 are clipped (or otherwise coupled) to collar 118, e.g., via clip 1026 (Figure 59). Second, collar 118 and coupled gaiters 1022, 1024 are assembled into lower housing portion 102b (Figures 60(a) and 60(b)). Also, actuatable lug 902 is shown protruding outwardly through lower housing portion 102b. Third, upper housing portion 102a is positioned over lower housing portion 102b (Figures 61(a) and 61(b)). Actuatable lugs 902, 904 are shown protruding outwardly and are configured to be received in corresponding slots in the outer sleeve. Fourth, the outer sleeve 134 is placed over the upper and lower housing portions 102a, 102b and secured in place, for example by welding or clipping (FIGS. 62(a) and 62(b)), to provide the assembled connector 1200.

[0355] As shown in Figures 63 through 75, another embodiment of a connector 1300 for connecting two volumes of fluid is provided. Connector 1300 is of the same construction as connector 1000 described in connection with Figures 51 through 62, except for the details listed below. Like reference numbers indicate like features.

[0356] 64(a) through 64(c) illustrate the first portion 134a (formed as the front portion) of the outer sleeve 134. The first portion 134a includes a sterile seal system access slot 1302a in the side wall 1032 of the first portion 134a. A recess for indicia 1304 is also provided on the outer surface of the side wall 1032. A ledge 1306a is also provided, extending laterally from the inner surface of the side wall 1032a and positioned to hold and retain the inner components of the connector 1300, as described further below. The ledge 1306a also includes a rail-receiving portion for receiving a sterile seal system. Additionally, shelf 1306a includes one or more apertures 1307 (in this embodiment, two apertures) configured and arranged to allow one or more pins of an actuation mechanism (not shown) to protrude therethrough to activate tongue 708 (see FIG. 69(a) as discussed below) and provide needle-safe activation of upper and lower housing portions 102a, 102b in a manner similar to that described in connection with FIGS. 21(a) through 21(e), 22(a) through 22(e), and 44(a) through 44(f). Top wall 1308a of first portion 134a includes aperture 1310a to allow upper housing portion 102a (see below) to protrude therethrough. First portion 134a also includes a recess 1311 that adjoins side wall 1032a to top wall 1308a, allowing the two portions to be welded together in use. Side wall 1032a further includes an arcuate slot 1309 for receiving a portion of second portion 134b, as described below.

[0357] FIGS. 65(a) through 65(c) illustrate the second portion 134b (formed as the rear portion) of the outer sleeve 134. A ledge 1306b is also provided, extending laterally from the inner surface of the sidewall 1306b and positioned to hold and retain the inner components of the connector 1300, as described further below. The ledge 1306b includes one or more apertures 1309 (in this embodiment, two apertures) configured and arranged to allow one or more pins of an actuation mechanism (not shown) to protrude therethrough to activate the tongue 708 (see FIG. 69(a) as discussed below) and provide needle-safe activation of the upper and lower housing portions 102a, 102b in the same manner as described above in connection with the aperture 1307 of FIGS. 64(a) and 64(b).

[0358] The second portion 134b includes a pair of longitudinal slots 1312 formed in its side walls 1032b to allow an actuation system to actuate the upper housing portion 102a and / or collar 118 during use. The longitudinal slots 1312 are shaped to prevent (or at least mitigate) user intervention with the actuable lug. The second portion 134b also includes an aperture 1310b formed in its top wall 1308b to allow the upper housing portion 102a (see below) to protrude therethrough, and a flat rear wall 1314 having a slot 1302b. The second portion 134b also includes a raised rib 1315 that adjoins the side walls 1032b to the top wall 1308b, the raised rib 1315 being received in a recess 1311 (see above) to allow the two portions to be welded together during use. Finally, side wall 1302b includes protective wall 1313, which is formed as a gripping area for a user and is positioned to be received by arcuate slot 1309 (see above). Protective wall 1313 overlaps and surrounds longitudinal slot 1312, helping to mitigate user access within longitudinal slot 1312.

[0359] It is noted that the first portion 134a and the second portion 134b may be separately or integrally formed. If the portions 134a, 134b are separately formed, any suitable means for connecting the portions 134a, 134b together is envisioned, including welding, adhesive, clipping, or the like.

[0360] Figures 66(a)-66(c), 67(a), and 67(b) illustrate the upper housing portion 102a of the connector 1300. The upper housing portion 102a is provided with anti-rotation features 1320, which in this example are formed as a plurality of angled notches adjacent to (or as part of) the threaded portion 107 of the connector 1300. The anti-rotation features 1320 can cooperate with corresponding anti-rotation features (e.g., complementary notches or lips) on the mating receptacle. As best shown in Figure 67(a), the septum seal 108 is co-molded with the upper housing portion 102a and, in use, is formed by a raised annular portion surrounding a flat portion for piercing.

[0361] Figures 68(a) and 68(b) illustrate another embodiment of the upper housing portion 102a of the connector 1300. The upper housing portion 102(a) is as described in Figures 66(a) through 66(c), 67(a), and 67(b) and further includes a pair of elongated ribs 1321 extending longitudinally on either side of the actuatable lugs 804a, 804b. The elongated ribs 1321 generally span the majority of the length of the upper housing portion 102a. In use, the elongated ribs 1321 are caused to frictionally engage a recess (not shown) or inner surface of the outer sleeve 134.

[0362] 69(a)-69(c), 70(a), and 70(b) illustrate the lower housing portion 102b of the connector 1300. As can be seen, the lower housing portion 102b includes an inner body portion 1006 that extends beyond the bottom edge of the outer body portion 1004. In this manner, better engagement with the components to be coupled can be achieved. Additionally, the lower housing portion 102b includes a co-molded septum seal 110, substantially as described above.

[0363] Lower housing portion 102b further includes a plurality of reinforcing ribs 1301, each connected to one of the tongues 708. Each rib 1301 extends longitudinally or axially and parallel to tongue 708, imparting stiffness (or increased strength) thereto. As described above in connection with Figures 21(a) through 21(e) and 22(a) through 22(e), tongue 708 serves as a needle safety feature.

[0364] FIGS. 71(a) and 71(b) illustrate another embodiment of the lower housing portion 102b of the connector 1300. As can be seen, the lower housing portion 102b is as described in FIGS. 69(a) through 69(c), 70(a), and 70(b), and further includes a pair of flanges 1007 extending outward from the outer surface of the outer body portion 1004. The pair of flanges 1007 are diametrically opposed to one another, i.e., they are offset by an angle of 180 degrees. In use, the pair of flanges 1007 are received in corresponding slots 1009 in the outer sleeve 134, as shown in FIG. 71(b), to resist movement of the lower housing portion 102b during use.

[0365] Figures 72(a) to 72(c) illustrate the hollow needle 112 and collar 118 of the connector 1300. The hollow needle 112 is as described above and includes, among other things, a pencil point closed end 1011 (i.e., a pointed closed end) that includes a port (or aperture) 1013 adjacent the pencil point closed end 1011 and extending perpendicular to the shaft of the hollow needle 112. The hollow needle further includes an open end 1015, which, in the embodiment shown, is beveled.

[0366] Figures 73(a) and 73(b) illustrate a further embodiment of the hollow needle 112 and collar 118 of the connector 1300. As can be seen, the hollow needle 112 is as described in Figures 72(a) through 72(c), but the port 1013 extends through the hollow needle 112 to form a pair of diametrically opposed openings 1013a, 1013b. This allows fluid to exit through each of the openings, reducing blockage of the hollow needle 112 during use. The hollow needle further includes a longitudinally extending slot 1017 extending from the open end 1015 toward the collar 118. This allows fluid to more easily exit from the connected container into the bore of the hollow needle 112.

[0367] 74(a) and 74(b) illustrate first and second gaiters 1022, 1024. The first gaiter 1022 includes a central portion 1022a sandwiched between two end portions 1022b, 1022c. The central portion 1022a has a longer length than the two end portions 1022b, 1022c. This arrangement assists in proper folding of the first gaiter 1022 during use. That is, the central portion 1022a of the bellows forms an elongated cylindrical region without a Z-fold. The elongated cylindrical region is adjacent to the two end portions 1022b, 1022c. The volume of the central portion 1022a can generally be larger than the volume of the end portions 1022b, 1022c.

[0368] Figures 75(a)-75(c), 76(a), and 76(b) illustrate a portion of a sterile seal system 1350, including a clip portion 1352. The clip portion 1352 is formed as a generally drawer-like feature. The clip portion 1352 includes a front wall 1354, a rear wall 1356, and two side walls 1358 adjacent the front wall 1354 and rear wall 1356. The side walls 1358 are each formed with a shoulder 1360. A base wall 1362 is provided having a circular protrusion 1364 extending therefrom. The front wall 1354, rear wall 1356, side walls 1358, and base wall 1362 generally define a hollow body. A plurality of reinforcing ribs 1363 are provided within the hollow body and extend parallel to the side walls 1358 and perpendicular to the front and rear walls 1354, 1356. In some examples, a top wall (not shown) may also be provided.

[0369] Clip portion 1352 is arranged to couple to a sterile membrane (not shown) by protrusion 1364. To this end, protrusion 1364 can include one or more retaining clips. Additionally, shoulder 1360 is arranged to be engaged by an actuation mechanism such that, when slidably received therein, it can push clip portion 1352 from outer sleeve 134. Thus, automated systems can be more easily implemented. Clip portion 1352 can be constructed from high-density polyethylene (HDPE), low-density polyethylene (LDPE), or a similar material.

[0370] 77(a) and 77(b) illustrate another embodiment of the clip portion 1352 of the connector 1300. As can be seen, the clip portion 1352 is as described in FIGS. 75(a) through 75(c), 76(a), and 76(b), and further includes a locating element formed as a longitudinally extending rib 1365 formed on each of the side walls 1358 of the clip portion 1352. The ribs 1365 cooperate with corresponding ribs 1367 (or alternatively, corresponding recesses) formed as part of the bottom portion of the outer sleeve 134.

[0371] 78(a) through 78(c) illustrate a transit cover 1370 for covering the bottom (i.e., proximal) end of the connector 1300 during shipping and storage. The transit cover 1370 is complementary in shape and size to the proximal end 106 of the connector 1300. Among other things, the transit cover 1370 includes a pair of protruding blocks 1372 that are configured to engage corresponding spaces in the connector 1300 and to engage a portion of the connector 1300 via a friction fit during use.

[0372] Figures 79(a) through 79(j) illustrate a method of assembling connector 1300. First, gaiters 1022, 1024 are assembled (Figure 79(a)). Second, gaiters 1022, 1024 are assembled to collar 118, surrounding hollow needle 112 (Figure 79(b)). Gaiters 1022, 1024 may be secured in place by any suitable means (e.g., clips, adhesive, or welding). Third, lower housing portion 102b is assembled to collar 118 (Figure 79(c)). Fourth, upper housing portion 102a is assembled to lower housing portion 102b (Figure 79(d)). Fifth, second portion 134b of outer sleeve 134 is assembled to the pre-assembled components of Figure 79(d) (Figure 79(e)). Sixth, the first portion 134a of the outer sleeve 134 is assembled to the second portion 134b of the outer sleeve 134 (FIG. 79(f)). The first portion 134a and the second portion 134b may be glued, welded, clipped, or the like to one another. Seventh, a sterile seal system 1350 is provided. The sterile seal system 1350 includes a sterile membrane 1351 and a clip portion 1352, as described above. The sterile membrane 1351 is affixed to the lower housing portion 102b and is adapted to aseptically seal the second septum seal 110. The clip portion 1352 is slidably engaged with the outer sleeve 134. The connector 1300 is then provided with the sterile seal system 1350 (FIG. 79(g)). Eighth, a transit cover 1370 (optionally constructed from polypropylene (PP) or low density polyethylene (LDPE)) is provided over the proximal end 106 of the connector 1300 (FIG. 79(h)). Ninth, a transit cap 1390 (optionally constructed from polypropylene (PP) or low density polyethylene (LDPE)) is provided over the distal end 104 of the connector 1300 (FIG. 79(i)). Tenth, indicia 1392 are added to a recessed area 1394 of the outer sleeve 134 (FIG. 79(j)).

[0373] Figure 80 illustrates an embodiment of an interface plate (or container lid) 1380 for use with any of the connectors as described herein. The interface plate 1380 is substantially similar to the interface plate 1150 and its associated operating mechanism as described in connection with Figures 50(a) and 50(b).

[0374] The interface plate 1380 includes a base 1381 having a side wall 1382 upstanding therefrom to a top wall 1384. The top wall 1384 generally overhangs the side wall 1382 and is provided with a plurality of reinforcing ribs 1385 connecting the side wall 1382 to the lower surface of the top wall 1384. The base wall 1381 includes connecting elements (e.g., screw threads or clips, etc.) to enable connection of the interface plate 1380 to a container, receptacle, or the like. The top wall 1384 is provided with an outer circular rim 1386 and a centrally disposed septum seal 1387 surrounded by a U-shaped upstanding positioning wall 1388. Septum seal 1387 is a generally planar (i.e., generally flat) septum seal that is recessed into the surface of top wall 1384. Rails 1390 are provided and extend radially outward from the open end of U-shaped positioning wall 1388. A sterile seal system 1392 is further provided and includes a clip portion 1394 and a sterile membrane 1396 attached to clip portion 1394. Sterile membrane 1396 is disposed over septum seal 1387 to sterilely seal it, and clip portion 1394 is received within rail 1390 so as to be slidably movable therewithin.

[0375] The interface plate 1380 in use will now be described with reference to the connector 1300 as shown in FIGS. 63 through 77 , although any of the other connectors described herein may be used. First, the connector 1300 is positioned, held, or otherwise retained above the top wall 1384 of the interface plate 1380. The connector 1300 (specifically, its sterile seal system 1350) is caused to engage with the sterile seal system 1392 of the interface plate 1380. In particular, the protrusion 1364 of the sterile seal system 1350 of the connector 1300 is caused to engage with the clip portion 1394 (specifically, the aperture 1397 in the clip portion 1394) of the sterile seal system 1392. Second, and simultaneously, the surface of the sterile membrane (not shown) of the sterile seal system 1350 of the container 1300 is caused to engage with the surface of the sterile membrane 1398 of the interface plate 1380. For example, the sterile membranes can each be folded to form a sterile surface (each sterile surface disposed over its respective septum seal 110, 1387) and a connecting surface (for connecting to a corresponding connecting surface of another sterile seal system). The connecting surfaces can be caused to engage and connect (or interlock) by any suitable means (e.g., adhesive, etc.). The upstanding wall 1388 assists in positioning the sterile membrane of the connector 1300 over the sterile membrane 1396 of the interface plate 1380.

[0376] Once the respective clip portions 1352, 1394 and respective sterile membranes are coupled, an actuation system (not shown) can engage the sterile seal system 1392 and / or the sterile seal system 1350 of the connector 1300 to slide the respective clip portions 1352, 1394 along a radial axis. Generally, the respective clip portions 1352, 1394 are slid along an axis extending from the septum seal 1387, the axis being generally defined by a rail 1390 that extends radially from a central location of the top wall 1384. In this manner, as the respective clip portions 1352, 1394 are slid away from the respective septum seal 110, 1387, the respective sterile membranes are caused to pull, peel, or otherwise remove in a direction distal to the respective septum seal 110, 1387. The particular removal step is dictated by the folding geometry of the sterile membrane in embodiments in which the sterile membrane is folded. Thus, by removing the respective sterile membranes, the respective septum seals 110, 1387 (i.e., of the connector 1300 and of the interface plate 1380) are permitted to engage with one another in a face-to-face and sterile (or aseptic) configuration. The connector 1300 can then be operated as described above, specifically by piercing the septum seals 110, 1387 with the hollow needle 112, thereby providing a fluid passageway through the respective septum seals 110, 1387, thereby fluidly connecting a fluid volume (e.g., one connected to an end of the connector 1300) to another fluid volume (e.g., one connected to an end of the interface plate 1380).

[0377] Although several embodiments are described herein, one skilled in the art will recognize that aspects of each embodiment are disclosed in combination with any other embodiment, such as any of the upper housing portion, lower housing portion, outer sleeve, collar, hollow needle, actuation mechanism, or sterile sealing system, etc., may be selected from those disclosed above.

[0378] As will be appreciated by those skilled in the art, components such as the connector, receptacle, and interface plate can be constructed from any suitable material. For example, the outer sleeve can be constructed from polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS); the sterile seal system can include a clip portion constructed from high density polyethylene (HDPE) and / or a sterile membrane constructed from polyethylene (PE); the collar can be constructed from polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS); the hollow needle can be constructed from stainless steel or another suitable biocompatible material or metal; the gaiter can be constructed from low density polyethylene (LDPE), thermoplastic elastomer (TPE), silicone, or the like; the gaiter clip can be constructed from high density polyethylene (HDPE); the lower housing portion ... lower housing portion can be constructed from polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS); the hollow needle can be constructed from stainless steel or another suitable biocompatible material or metal; the gaiter can be constructed from low The upper housing portion may be constructed of polycarbonate, acrylonitrile butadiene styrene (ABS), or high impact polystyrene sheet (HIPS); the pierceable seal of the lower housing portion may be constructed of a thermoplastic elastomer or silicone and / or may be co-molded with the lower housing portion; the upper housing portion may be constructed of polycarbonate, acrylonitrile butadiene styrene (ABS), or high impact polystyrene sheet (HIPS); the pierceable seal of the upper housing portion may be constructed of a thermoplastic elastomer (TPE) or silicone and / or may be co-molded with the upper housing portion; and the transit cover and / or transit cap may be constructed of polypropylene (PP), low-density polyethylene (LDPE), or a combination thereof. As discussed above, any combination of materials is also contemplated. In addition to being suitable for cell therapy and / or gene therapy manufacturing, such materials offer multiple manufacturing and processing advantages.

[0379] In general, the above-described embodiments have been described by way of example only and not in a limiting sense, and it will be recognized by those skilled in the art that various alternatives and modifications are possible without departing from the scope of the present invention as defined by the appended claims. Various modifications to the detailed designs as described above are possible, and there may be variations in shape, size, arrangement, assembly, or sequence, for example. [Explanation of symbols]

[0380] 100 Connectors 102 Housing 102a Upper housing part 102b Lower housing part 104 distal end 106 Proximal end 107 Threaded Part 108 First Septum Seal 110 Second septum seal 111 Removable sterile paper seal 112 Hollow needle 114 first end 116 Second end 118 Color 120 First Helical Spring 122 Second helical spring 124 upper surface 126 Inner surface 128 Lower surface 130 Inner surface 132 Operating Mechanism 134 Outer sleeve 134a, 134b Half-pipe section 134c Features 136 Rail 138 Circumferential groove 140 aperture 200 First Container 202 first volume of fluid 204 Septum seal 206 Recess 208 Threaded Part 300 Second Container 302 second volume of fluid 304 Septum Seal 306 Removable sterile paper seal 308 Leg 310 Protrusion 400 Connector 402 Cap 500 First Container 502 a first volume of fluid 504 Threaded Outer Sleeve 506 Septum Seal 600 Second Container 602 second volume of fluid 604 Septum Seal 700 Connector 702 teeth 704 Arm 706 Hook part 708 Tongue 710 Circumferential Skirt 712 Slots 714 Elastically deformable parts 716 Ledge 720 Window 722 circular stud 724 Slots 730 Aseptic Sealing System 732 Clip part 734 Sterile membrane 735 Lateral Rail 736 Upright Wall 738 Aperture 740 Protrusion 742 Folding section 744 Sterile Surface 746 Mating Surface 760 Gator 762 Distal end 764 Proximal end 800 Connector 802 Single Helical Spring 804a, 804b Operable lugs 806 Longitudinal Slot 900 Connector 902 Working Lug 904 Working Lug 906 first plurality of longitudinal slots 908 second plurality of longitudinal slots 1000 Connectors 1002 longitudinal slot 1004 Outer body part 1006 Inner body part 1007 Flange 1008 Circular Space 1009 Slots 1010 Slots 1011 Pencil Point Closed End 1012 Slots Port 1013 1013a, 1013b opening 1014 Slots 1015 Open end 1016 Outer body part 1017 Slots 1018 Inner body part 1020 Annular recess 1022 The First Gator 1022a central part 1022b, 1022c end section 1024 The Second Gator 1026 Gator Clip 1030 Longitudinal Slot 1032 Side wall 1034 base 1036 Aseptic Sealing System Receiving Area 1038 Longitudinal groove 1040 aperture 1050 Transit Cover 1060 Transit Cap 1100 Retention Mechanism 1102 Side wall 1104 Base 1106 Slots 1108 Notch 1110 Cutout Area 1150 Interface Plate 1152 Aseptic Sealing System 1154 Projecting part 1156 Sterile membrane 1158 Septum Seal 1160 Bioreactor 1200 Connector 1250 Aseptic Sealing System 1252 Clip part 1254 Sterile membrane 1256 lateral rail 1258 Semicircular wall 1259 Shoulder part 1260 Protrusion 1262 Base 1263 Reinforced Rib 1265 Attachment position 1270 aperture 1272 Access Slots 1274 Raised circular area 1276 Flat Area 1278 fixed points 1280 access slots 1282 steps 1300 Connector 1301 Reinforced rib 1302a Aseptic Seal System Access Slot 1302b Aseptic Seal System Access Slot 1304 Sign 1306a Shelf 1306b Shelf 1307 Aperture 1308a Upper wall 1308b Upper wall 1309 Arc-shaped slot, aperture 1310a aperture 1310b aperture 1311 recess 1312 Longitudinal slot 1313 Protective wall section 1314 Rear wall 1315 Raised Ribs 1320 Anti-rotation feature 1321 Long rib 1350 Aseptic Sealing System 1352 Clip part 1354 Front wall 1356 Rear wall 1358 Side wall 1360 Shoulder part 1362 Base wall 1363 Reinforced Rib 1364 Circular protrusion 1365 Ribs 1367 Rib 1370 Transit Cover 1372 Protruding Block 1380 Interface Plate 1381 Base wall 1382 Side wall 1384 Upper wall 1385 Reinforced rib 1386 outer circular rim 1387 Septum Seal 1388 U-shaped upright positioning wall 1390 Transit Cap, Rail 1392 Mark, Sterile Sealing System 1394 Clip part 1396 Sterile membrane 1397 Aperture 1398 Sterile membrane F1 First Force F2 Second biasing force

Claims

1. a first sterile seal system including a first clip portion and a first sterile membrane, the first clip portion including a first connecting element, the first sterile membrane operably connected to the first clip portion and disposed over at least a portion of a first pierceable seal; a second sterile seal system including a second clip portion and a second sterile membrane, the second clip portion including a second connecting element configured to operably connect to the first connecting element, the second sterile membrane operably connected to the second clip portion and configured to operably connect to the first sterile membrane, and the second sterile seal system being disposed over at least a portion of the second pierceable seal; A sterile connection construct comprising:

2. 2. The sterile connection arrangement of claim 1, wherein the first sterile membrane and / or the second sterile membrane are disposed over the entire first pierceable seal and / or the second pierceable seal.

3. 2. The sterile connection arrangement of claim 1, wherein the first sterile sealing system and / or the second sterile sealing system are sterile sealing systems of a connector, and the first pierceable seal and / or the second pierceable seal are formed as part of the connector.

4. 4. The sterile connection arrangement of claim 3, wherein the connector is a needle-type connector.

5. 2. The sterile connection arrangement of claim 1, wherein the first and / or second sterile sealing system is a sterile sealing system of a container, a bioreactor, or an interface plate, and the first and / or second pierceable seal is formed as part of the container, the bioreactor, or the interface plate.

6. 2. The sterile connection arrangement of claim 1, wherein the first pierceable seal and / or the second pierceable seal is a hermetic seal, a resealable seal, or a septum seal.

7. 2. The sterile connection arrangement of claim 1, wherein the first sterile sealing system and / or the second sterile sealing system are arranged to be actuated by an actuation system.

8. 8. The sterile connection configuration of claim 7, wherein when the first sterile seal system and / or the second sterile seal system is activated, the first sterile membrane and / or the second sterile membrane is removed from the first pierceable seal and / or the second pierceable seal.

9. the first clip portion being slidably and operably coupled to a portion of a component on which the first pierceable seal is disposed; and / or 10. The sterile connection arrangement of claim 1, wherein the second clip portion is slidably and operably coupled to a portion of a component on which the second pierceable seal is disposed.

10. 10. The sterile connection arrangement of claim 9, wherein the first and / or second sterile seal systems are arranged to be actuated to slidably move the first and / or second clip portions, thereby removing the first and / or second sterile membranes from the first and / or second pierceable seals.

11. 2. The sterile connection arrangement of claim 1, wherein the first and / or second sterile seal systems are arranged to be actuated between a first configuration and a second configuration, wherein in the first configuration the first and second sterile membranes are at least partially disposed to cover the first and second pierceable seals, and wherein in the second configuration the first and second sterile membranes are removed from the first and second pierceable seals.

12. 2. The sterile connection construct of claim 1, wherein the first and second clip portions comprise a front wall, a rear wall, side walls adjacent the front and rear walls, and a bottom wall, the front wall comprising one or more protruding shoulders.

13. 2. The sterile connection arrangement of claim 1, wherein the first sterile membrane and / or the second sterile membrane is a sterile paper seal or a sterile polyethylene film.

14. 2. The sterile connection arrangement of claim 1, wherein the first and second sterile membranes each include at least one fold that forms a first surface configured to provide a sterile seal for the first and second pierceable seal, respectively, and a second surface configured to mate with the first or second pierceable seal.

15. 1. A method for operating a sterile connection construct, comprising: providing a first sterile seal system including a first clip portion and a first sterile membrane, the first clip portion including a first connecting element, the first sterile membrane operably connected to the first clip portion and disposed over at least a portion of a first pierceable seal; a second sterile seal system including a second clip portion and a second sterile membrane, the second clip portion including a second connecting element, the second sterile membrane operably connected to the second clip portion, configured to operably connect to the first sterile membrane, and disposed over at least a portion of a second pierceable seal; operably connecting the first connecting element to the second connecting element; operably connecting the first sterile membrane to the second sterile membrane; activating the first sterile seal system and / or the second sterile seal system, wherein the first sterile membrane is removed from at least a portion of the first pierceable seal and the second pierceable seal to aseptically couple an outer surface of the first pierceable seal to an outer surface of the second pierceable seal; A method comprising:

16. 16. The method of claim 15, further comprising the step of bringing the outer surface of the first pierceable seal into sterile face-to-face engagement with the outer surface of the second pierceable seal.

17. 16. The method of claim 15, further comprising disposing of the first sterile sealing system and / or the second sterile sealing system after use.

18. The method of claim 15, further comprising providing a fluid passageway through the first pierceable seal and the second pierceable seal.

19. 20. The method of claim 18, wherein the fluid passage is provided by a needle-type connector.

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