connector

Abstract

A connector for introducing or removing material to or from at least one recipient is provided, the connector comprising: a housing extending between a distal end and a proximal end, the housing comprising a pierceable seal at least at one end; a hollow needle at least partially mounted 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 respective first recipient and a second end of the hollow needle facing the pierceable seal at one 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 to form a communication through the pierceable seal to enable transfer of material through the connector.

Description

Technical Field

[0001] This invention relates to a connector, such as a sterile connector. More specifically, this invention relates to a connector for introducing material into or removing material from at least one receiver. The connector described herein can be incorporated into a cell and / or gene therapy manufacturing apparatus or process. Background Technology

[0002] Cell and gene therapy manufacturing processes are typically complex and involve manual or semi-automated steps across multiple devices. The equipment systems used in the various steps or unit operations of cell-based therapeutic products (CTP) manufacturing can include devices for a wide range of functions. These functions may include cell collection, cell isolation, cell selection, cell expansion, cell washing, volume reduction, cell storage, or delivery. Unit operations can vary considerably depending on the manufacturing model (i.e., autologous vs. allogeneic), cell type, intended purpose, and other factors. Furthermore, cells are “living” entities sensitive to even the simplest operations, such as variations in cell transfer procedures. The role of cell manufacturing equipment in ensuring scalability and reproducibility is a crucial factor in cell and gene therapy manufacturing.

[0003] Furthermore, cell-based therapeutic products (CTPs) have seen significant growth, necessitating improvements in cell manufacturing equipment for various cell manufacturing procedures. These procedures may include, for example, stem cell enrichment, chimeric antigen receptor (CAR) T cell generation, and various cell manufacturing processes such as collection, purification, genetic modification, incubation, recovery, washing, infusion into patients, or freezing.

[0004] Cell culture or processing typically requires the use of devices to contain the cells, such as placing them in a suitable culture medium during cell culture. Known devices include shake flasks, roller flasks, T-flasks, bags, etc. These devices usually need to be connected to other devices (such as containers, interfaces, etc.) to allow various media to be introduced into or removed from the cell-containing device.

[0005] Therefore, during cell and gene therapy manufacturing processes, it is necessary to connect one device to another to achieve fluid communication between devices. Furthermore, it is generally desirable to provide sterile or sterile connections between various devices, thereby enabling sterile or sterile fluid connections. However, known connectors have several drawbacks.

[0006] In some known connectors, particularly sterile connectors, a first device or container with a first fluid volume can be connected to a second device or container with a second fluid volume via a genderless connector, a male-female connector, a threaded connector, etc. 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. Each of the first and second portions of the connector includes opposing removable adhesive strips facing each other and providing a sterile sealing end for both the first and second devices. In use, a connection is formed between the first and second portions of the connector, and the opposing adhesive strips are adhered to each other. The user then removes the adhesive strips, thereby removing the adhered sterile strips from the connection. In this way, a sterile fluid path is provided between the first and second devices.

[0007] However, this type of sterilized connector has several drawbacks. The main disadvantage is that the first or second device or container cannot be disconnected and / or reconnected under sterile conditions. Instead, a non-sterile environment is created when the first and second parts of the connector are disconnected. Therefore, it is necessary to dispose of the connector or to sterilize it, both of which are costly for the user. Furthermore, the adhesive strip in this sterilized connector is unsuitable when in contact with liquids or under pressure (i.e., pressure greater than atmospheric pressure). Additionally, this adhesive strip is not suitable for automated processes and requires cumbersome assembly by the user.

[0008] Therefore, the object of the present invention is to address some of the drawbacks associated with known connectors (especially sterile connectors). Summary of the Invention

[0009] According to one aspect of the invention, a connector is provided for introducing material into or removing material from at least one receiver, the connector comprising:

[0010] A housing extending between a distal and a proximal end, the housing including a puncture-resistant seal at at least one end; and

[0011] A hollow needle, at least partially installed within the housing, is located between the distal and proximal ends of the housing. A first end of the hollow needle is connected to or can be connected to a first receiver, and a second end of the hollow needle faces a punctureable seal at one end of the housing.

[0012] An actuating mechanism acts on the housing or hollow needle to enable the hollow needle to pierce a pierceable seal, thereby creating a connection through the pierceable seal and allowing material to be transferred through the connector.

[0013] Appropriately, in some embodiments, the connector includes a housing that extends longitudinally between the distal and proximal ends.

[0014] 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 a specific embodiment, both the distal and proximal ends of the connector housing include pierceable seals.

[0015] In some embodiments, the first end of the hollow needle may be connected to the first receiver.

[0016] In some embodiments, the first end of the hollow needle is in communication with or can be in communication with the first receiver.

[0017] In some embodiments, the first receiving device includes material. The first receiving device can be any container capable of holding the material.

[0018] The material can be a solid. The material can be a fluid. The material can be a gas.

[0019] In some embodiments, the first end of the hollow needle may be pre-connected to the first receiver. For example, a connector may be part of the receiver.

[0020] In some embodiments, the hollow needle is directly connected to the first receiver.

[0021] In another aspect of the invention, a receiver is also provided, which includes a connector as described herein. In some embodiments, the connector may be part of a bioreactor.

[0022] In some embodiments, the connector may be configured and arranged to connect to the first receiver.

[0023] Appropriately, the hollow needle is configured to protrude through or puncture a punctureable seal. For example, the hollow needle may be pointed at one or both ends. In some embodiments, the hollow needle includes a pointed tip. In a particular embodiment, the hollow needle is pointed at both ends. In a particular embodiment, the hollow needle is double-ended. In a particular embodiment, the first or second end includes a nib-closed end and a port adjacent to the nib-closed end, i.e., a Whittare end. That is, this port allows fluid to flow into and / or out of the hollow orifice of the hollow needle. In a particular embodiment, the first end of the second end includes an open end. In a particular embodiment, the open end includes a beveled or chamfered open end. That is, the open end (such as a beveled or chamfered open end) allows fluid to flow into and / or out of the hollow orifice of the hollow needle.

[0024] In a particular embodiment, a longitudinally extending slot is disposed within the hollow needle, extending from the open end toward the opposite end (e.g., toward the collar). This provides the advantage that the longitudinally extending slot facilitates the drainage of fluid (e.g., liquid or material) from the fluid-connected receiver.

[0025] In a specific embodiment, 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 is made of stainless steel.

[0026] For ease of description herein, the distal end of the connector refers to the upper first end of the connector, which is away from the second receiver. For ease of description herein, the proximal end of the connector refers to the lower second end of the connector, which is close to the second receiver. These terms used to describe the ends of the connector housing or other parts of the connector are not intended to be limiting, but are merely for the purpose of describing the invention.

[0027] Advantageously, the present invention provides an easy-to-use connector for connecting a first receiver to a second receiver. Advantageously, this allows for the connection of a first receiver, for example, containing a fluid or a solid, to a second receiver, for example, containing a fluid or a solid. More advantageously, the present invention provides a connector suitable for automation (e.g., suitable for use in automated cell and / or gene therapy manufacturing processes).

[0028] Advantageously, the connector allows for easy communication between one or more receiving components for the introduction or removal of material. The introduction or removal of material can be achieved through any method mediated by the connector. For example, the connector facilitates the introduction of material into a container, or it facilitates the removal of material from a receiving component.

[0029] Those skilled in the art will appreciate that the present invention is applicable to the introduction or removal of any suitable material, such as fluids or solids. Fluids typically include liquids and gases, but may also include solutions, suspensions, gels, pastes, etc. Solids may be granular, such as powders. In some embodiments, a volume of fluid in the first or second receiver comprises one or more solids and one or more fluids. In some embodiments, one or more solids may be suspended within the fluid (e.g., a liquid). In some instances, the solid may comprise one or more magnetic beads for use in cell culture or processing. One or more magnetic beads may be suspended within the fluid (e.g., a liquid) or may not be suspended within the fluid.

[0030] The material may include magnetic beads. The material may include multiple magnetic beads.

[0031] The connector of this invention offers the advantage that the first receiver can be connected, disconnected, and reconnected to a second receiver via the connector. More specifically, the connection, disconnection, and reconnection can be performed in a sterile or aseptic manner. Furthermore, the connector may be more suitable for automated processes and may be easier to handle and use.

[0032] In some embodiments, the actuation mechanism may include a bias-mounted hollow needle.

[0033] In some embodiments, the hollow needle is biased mounted. In a specific embodiment, the hollow needle is at least partially biased mounted within the connector housing. In a specific embodiment, the hollow needle is at least partially biased mounted within the housing, and the longitudinal length of the needle extends at least partially between the proximal and distal ends of the connector housing. The hollow needle can be biased mounted in any manner. In some embodiments, a biasing mechanism is present to provide a first biasing force. This first biasing force can bias the hollow needle. In a specific embodiment, two biasing mechanisms are present to bias the hollow needle. In an embodiment with two biasing mechanisms, a second biasing mechanism can provide a second biasing force. This second biasing force can be applied to the hollow needle. In some embodiments, the connector includes springs to bias the hollow needle. In a specific embodiment, the connector includes two springs to bias the hollow needle. The hollow needle can be biased along one or both directions. In some embodiments, the first biasing mechanism includes a spring. In some embodiments, the second biasing mechanism includes a spring. In a specific embodiment, both the first and second biasing mechanisms include springs. In a more specific embodiment, the spring, or each spring, may be a helical spring.

[0034] In some embodiments, the actuation mechanism includes a collar. In some embodiments, the actuation mechanism includes a track. In some embodiments, the actuation mechanism includes a collar and a track. In some embodiments, the collar is attached to the housing of the connector. In some embodiments, the track is attached to the housing. In some embodiments, the collar is configured to move along the length of the track. In some embodiments, the collar includes one or more protrusions configured to engage the track.

[0035] In some embodiments, the bias-mounted pin is received by a collar within the connector housing. The collar can be considered a pin holder.

[0036] In some embodiments, the connector further includes an actuation mechanism to enable the hollow needle to pierce the pierceable seal, thereby connecting to the second receiver.

[0037] In some embodiments, the connector further includes an actuation mechanism to enable the hollow needle to pierce the pierceable seal.

[0038] In some embodiments, the connector further includes an actuation mechanism to enable a hollow needle to pierce a pierceable seal, thereby forming a connection through the pierceable seal.

[0039] In some embodiments, the connector further includes an actuation mechanism to enable a hollow needle to pierce a pierceable seal, thereby forming a connection through the pierceable seal, allowing material to be transferred through the connector.

[0040] This offers the advantage that the connector can be manually actuated without the risk of needlestick injury, or it can be actuated by an automated system. In some embodiments, this can advantageously enable the two receivers to be sterilized and connected.

[0041] The actuation mechanism may include the retraction or partial retraction of the housing. In some embodiments, the actuation mechanism includes a retractable housing.

[0042] Advantageously, this is a simple mechanism for connecting two receivers in an easy-to-use manner. The retractable housing for the connector is likely inexpensive and easy to manufacture. Advantageously, the connector with the retractable housing can be disposable.

[0043] In some embodiments, the actuation mechanism moves the hollow needle so that it can pierce the pierceable seal and connect to the second receiver.

[0044] In some embodiments, the actuating mechanism moves the hollow needle to pierce the pierceable seal. In some embodiments, the actuating mechanism moves the hollow needle to pierce the pierceable seal, thereby establishing communication with the second receiver. In some embodiments, the actuating mechanism moves the hollow needle to pierce the pierceable seal, thereby establishing communication through the pierceable seal with the second receiver.

[0045] In some embodiments, the actuation mechanism enables the hollow needle to translate axially. Axial translation of the hollow needle allows it to pierce a pierceable seal. In some embodiments, the actuation mechanism enables the hollow needle to translate axially to pierce a pierceable seal at the proximal end of the connector housing. In some embodiments, the actuation mechanism enables the hollow needle to translate axially to pierce a pierceable seal at the distal end of the connector housing. In some embodiments, the actuation mechanism enables the pierceable seal at the proximal end of the connector housing to translate axially to contact the hollow needle, thereby piercing the pierceable seal at the proximal end of the connector housing. In some embodiments, the actuation mechanism enables the pierceable seal at the distal end of the connector housing to translate axially to contact the hollow needle, thereby piercing the pierceable seal at the distal end of the connector housing.

[0046] In some embodiments, piercing a pierceable seal thereby forming a connection through the pierceable seal.

[0047] In some embodiments, piercing the pierceable seal creates a connection through the pierceable seal, allowing material to be transferred through the connector.

[0048] In a specific embodiment, the actuation mechanism enables the hollow needle to pierce the pierceable seals at the proximal and distal ends of the connector housing.

[0049] In a specific embodiment, when the actuation mechanism enables the hollow needle to pierce the pierceable parts at the proximal and distal ends of the connector housing, this can be achieved, for example, by axial translation of the hollow needle and axial translation of one of the pierceable seals.

[0050] In some embodiments, the actuation mechanism moves the housing or a portion of the housing to enable the hollow needle to pierce the pierceable seal, thereby connecting it to the second receiver.

[0051] In some embodiments, the actuation mechanism moves the housing or a portion of the housing so that the hollow needle can pierce the pierceable seal, thereby communicating with the second receiver.

[0052] In some embodiments, the housing is retractable between the proximal and distal ends to allow a hollow needle to pierce a pierceable seal, thereby connecting to a second receiver.

[0053] In some embodiments, the housing is retractable between the proximal and distal ends to allow a hollow needle to pierce a pierceable seal, thereby communicating with a second receiver.

[0054] In some embodiments, the actuation mechanism includes an outer sleeve configured such that a hollow needle can pierce a pierceable seal to connect to a second receiver.

[0055] In some embodiments, the actuation mechanism includes an outer sleeve configured such that a hollow needle can pierce a pierceable seal to communicate with a second receiver.

[0056] In some embodiments, the outer sleeve is configured such that at least a portion of rotation of the outer sleeve causes axial translation of the hollow needle to pierce the pierceable seal, thereby connecting it to the second receiver.

[0057] In some embodiments, the outer sleeve is configured such that at least a portion of rotation of the outer sleeve causes axial translation of the hollow needle to pierce the pierceable seal, thereby communicating with the second receiver.

[0058] This offers the advantage that the connector can be manually actuated without the risk of needle prick injury.

[0059] In some embodiments, a first end of the hollow needle is connected to or may be connected to a first receiver, and an actuation mechanism enables the hollow needle to pierce a pierceable seal to connect a second end of the hollow needle to a second receiver.

[0060] In some embodiments, a first end of the hollow needle is connected to or may be connected to a first receiver, and an actuation mechanism enables the hollow needle to pierce a pierceable seal so that a second end of the hollow needle can communicate with a second receiver.

[0061] In some embodiments, the actuation mechanism may be configured such that it is operable only when the connector has engaged with both the first and second receivers. That is, in some embodiments, the actuation mechanism is operable only when the first receiver is connected to the distal end of the housing and when the second receiver is connected to the proximal end of the housing.

[0062] In some embodiments, the actuation mechanism may include one or more engagement portions configured to engage with corresponding portions of the receiver, such that the actuation mechanism is operable when the engagement portions or each engagement portion engages with a corresponding portion.

[0063] This provides the advantage of avoiding needle prick injuries, because the hollow needle can only be actuated when connected to the corresponding first and second receivers.

[0064] In some embodiments, the outer sleeve is configured such that it creates a releasable locking engagement between the proximal end of the outer sleeve of the connector and a portion of a corresponding receiver (e.g., a second receiver).

[0065] This provides the advantage that users can easily identify whether the connector is correctly connected to the corresponding receiver by touch, sight, or tactile vision.

[0066] In some embodiments, the connector of the present invention can be releasably attached to one or more receivers. In some embodiments, the connector can be releasably attached to one or more receivers in a fluid-tight manner. In some embodiments, the connector can be releasably attached to one or more receivers in a sterile-tight manner.

[0067] In some embodiments, the retractable housing includes an upper housing portion and a lower housing portion, the upper housing portion being axially movable relative to the lower housing portion along a central longitudinal axis. Therefore, the upper housing portion can retract relative to the lower housing portion. In some examples, retracting the upper housing portion relative to the lower housing portion results in a hollow needle piercing through a puncture-resistant seal in the housing portion.

[0068] In some embodiments, a first portion of the retractable housing may be axially movable or translated relative to a second portion of the retractable housing along a central axis extending between the distal and proximal ends of the connector. Therefore, a movable portion and a fixed portion of the housing can be provided.

[0069] In some embodiments, the outer sleeve may allow the upper housing portion to retract or actuate relative to the lower housing portion.

[0070] Therefore, the outer sleeve can be considered as part of the actuation mechanism.

[0071] Alternatively, in some embodiments, the retractable housing includes an upper housing portion and a lower housing portion, the lower housing portion being axially movable relative to the upper housing portion along a central longitudinal axis. Therefore, the lower housing portion can retract relative to the upper housing portion. In some examples, retracting the lower housing portion relative to the upper housing portion results in a hollow needle piercing a puncture-resistant seal in the lower housing portion.

[0072] Further optionally, in some embodiments, the retractable housing includes an upper housing portion and a lower housing portion, the lower housing portion being axially movable relative to the upper housing portion along a central longitudinal axis, and the upper housing portion being axially movable relative to the lower housing portion along a central longitudinal axis. Therefore, each of the lower and upper housing portions can retract relative to each other. In some examples, retracting the lower housing portion relative to the upper housing portion and retracting the upper housing portion relative to the lower housing portion results in a hollow needle piercing a pierceable seal on both the housing portion and the lower housing portion. The sequential piercing of the seals can be controlled by the order of retraction.

[0073] In some embodiments, the upper housing portion includes at least one actuable lug configured to move the upper housing portion along a central longitudinal axis, the at least one actuable lug of the upper housing portion protruding at least partially, or substantially, 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 through which the actuable lug of the upper housing protrudes at least partially.

[0074] This provides the connector with the advantage of being suitable for automated actuation. Therefore, the connector is advantageously suited for automated cell and / or gene therapy manufacturing processes.

[0075] In some embodiments, the upper housing portion includes a plurality of actuable lugs. In some embodiments, the outer sleeve includes a plurality of slots. In a particular embodiment, each actuable lug protrudes at least partially, or substantially, or completely through one of the plurality of slots.

[0076] In some embodiments, the upper housing portion includes a pair of diameter-opposing actuating lugs. In some embodiments, the outer sleeve includes a pair of diameter-opposing slots. In a specific embodiment, each actuating lug protrudes at least partially through one of the pair of slots.

[0077] In some embodiments, the actuable lugs of the upper housing portion have a circular or cross-shaped (i.e., cross-shaped) cross section.

[0078] 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 being disposed on either side of an actuable lug of the upper housing portion. In a particular embodiment, the rib or each rib of the upper housing portion may be configured and arranged to mate with one or more corresponding recesses on the outer sleeve. In other embodiments, the rib or each rib of the upper housing portion may be configured and arranged to frictionally engage with the inner wall of the outer sleeve.

[0079] This provides the advantage of preventing rotational movement of the upper housing portion, particularly within the outer sleeve. Therefore, the hollow needle is held in a substantially vertical or longitudinally extending manner. In this way, the hollow needle moves substantially or completely axially during use, rather than forming an angle relative to the punctureable seal during actuation. Thus, a consistent puncture action can be achieved.

[0080] In some embodiments, the lower housing portion includes at least one outwardly extending flange. The outwardly extending flange extends outward from the outer surface of the lower housing portion (i.e., away from the central longitudinal axis 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 one or more outwardly extending flanges, or each outwardly extending flange, may be configured and arranged to be received in one or more corresponding slots of the outer sleeve.

[0081] This provides the advantage that the lower housing portion is held statically on the outer sleeve relative to the upper housing portion. Therefore, more reliable actuation of the connector can be ensured.

[0082] In some embodiments, the actuation mechanism includes a collar operably coupled to a hollow needle, the collar including at least one actuable lug configured to move the collar along a central longitudinal axis, the at least one actuable lug of the collar projecting at least partially through at least one slot in an outer sleeve. That is, in some embodiments, the outer sleeve further includes at least one slot through which the actuable lug of the collar projecting at least partially. Such at least one slot may be different from or the same as at least one slot from which the actuable lug of the upper housing portion projecting at least partially, i.e., a separate or integrated slot for the actuable lug of the collar and the actuable lug of the upper housing portion.

[0083] In some instances, the axial translation of the collar, and consequently the axial translation of the hollow needle along the central longitudinal axis toward the proximal end, causes the hollow needle to pierce the punctureable sealing seal of the lower housing portion.

[0084] This offers the advantage that the connector can be actuated sequentially by an automated system. Furthermore, it provides the advantage that the puncture sequence can be controlled by an automated system. Additionally, the use of this connector and the puncture of its seals are less susceptible to human error.

[0085] In some embodiments, the actuating lug of the collar has a circular or cross-shaped (i.e., cross-shaped) cross section.

[0086] In some embodiments, the collar includes a plurality of actuable lugs. In some embodiments, the outer sleeve includes a plurality of slots. In a particular embodiment, each actuable lug protrudes at least partially, or mostly, or completely through one of the plurality of slots.

[0087] In some embodiments, the collar includes a pair of actuating lugs with opposing diameters. In some embodiments, the outer sleeve includes a pair of slots with opposing diameters. In a specific embodiment, each actuating lug of the collar protrudes at least partially, or substantially, or completely through one of the slots.

[0088] In a specific embodiment, the outer sleeve includes a first set of multiple slots, each slot being configured and arranged such that an actuating lug of the upper housing portion protrudes at least partially, or substantially, or completely from the slot, and the outer sleeve includes a second set of multiple slots, each slot being configured and arranged such that an actuating lug of the collar protrudes at least partially, or substantially, or completely from the slot.

[0089] That is, in some embodiments, the actuating lugs of the upper housing portion have different slots, and the actuating lugs of the collar have different slots. In some examples, each slot in the first set of multiple slots may be spaced approximately 120° apart around the outer sleeve. In some examples, each slot in the second set of multiple slots may be spaced 120° apart around the outer sleeve and offset relative to the first set of multiple slots.

[0090] This provides the advantage that separate actuation mechanisms can be provided for engaging different actuable lugs.

[0091] In a specific embodiment, the outer sleeve includes a first slot and a second slot opposite to the diameter of the first slot, wherein one of the lugs of a pair of actuating lugs of the collar and one of the lugs of a pair of actuating lugs of the upper housing portion protrudes at least partially, or mostly, or completely through the first slot, and wherein the other lug of a pair of actuating lugs of the collar and the other lug of a pair of actuating lugs of the upper housing portion protrudes at least partially, or mostly, or completely through the second slot.

[0092] That is, the first slot includes an actuating lug of a collar and an actuating lug of the upper housing portion, both of which protrude at least partially therefrom. Similarly, the second slot includes an actuating lug of a collar and an actuating lug of the upper housing portion, both of which protrude at least partially therefrom.

[0093] Specifically, the outer sleeve includes a sidewall having a first slot and a second slot opposite to the diameter of the first slot. The first slot receives a first actuated lug of the upper housing portion and a first actuated lug of the collar. The second slot receives a second actuated lug of the upper housing portion and a second actuated lug of the collar.

[0094] More specifically, in some embodiments, the outer sleeve includes a sidewall having a first slot and a second slot, the second slot being diametrically opposed to the first slot; the upper housing portion includes a first actuable lug extending from the body of the upper housing portion and a second actuable lug extending from the body of the upper housing portion, the first actuable lug and the second actuable lug being diametrically opposed to each other; the collar includes a first actuable lug extending from the outer wall of the collar and a second actuable lug extending from the outer wall of the collar, the first actuable lug and the second actuable lug being diametrically opposed to each other; wherein the first actuable lug of the upper housing and the first actuable lug of the collar at least partially protrude through the first slot of the outer sleeve, and wherein the second actuable lug of the upper housing and the second actuable lug of the collar at least partially protrude through the second slot of the outer sleeve.

[0095] This offers the advantage of utilizing a smaller footprint actuator.

[0096] Typically, one or more slots in the outer sleeve provide access to the actuated lugs of the upper housing portion and / or collar. These slots may allow user access (i.e., manual access) or robotic access (i.e., automated access).

[0097] In some embodiments, the outer sleeve includes a sidewall, which is preferably substantially cylindrical. In some embodiments, one or more slots (i.e., a first slot or a first set of multiple slots and / or a second slot or a second set of multiple slots) are formed within the sidewall. The outer sleeve may be formed from two half-tube portions operatively joined together to form the outer sleeve. The two half-tube portions may be welded, bonded, clamped, etc., to each other.

[0098] In some embodiments, the outer sleeve includes a front wall, a rear wall, and side walls adjacent to the front and rear walls. There may be two side walls. In some examples, one or more slots (i.e., a first slot or a first set of multiple slots and / or a second slot or a second set of multiple slots) are disposed within said side walls or each side wall. The outer sleeve may further include a protective wall that forms a gripping area of ​​the outer sleeve, extending over one or more slots. In this way, the protective wall is configured to prevent manual access to components within the outer sleeve while allowing automated actuation of the connector. The protective wall may be knurled or similar to enhance the user's grip.

[0099] In some embodiments, at least one gaiter is provided to surround the hollow needle. In some examples, a single flexible gaiter is provided to surround the hollow needle and the collar. In other examples, 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 the upper surface of the collar to the lower surface of the upper housing portion. The second flexible gaiter can extend from the lower surface of the collar to the upper surface of the lower housing portion. The at least one gaiter can surround the hollow needle in a sterile or sterile environment. Therefore, the at least one gaiter can seal the hollow needle therein under sterile conditions. Therefore, the at least one gaiter can provide a tight seal for the hollow needle therein.

[0100] This provides the advantage of ensuring a sterile environment around the hollow needle. Furthermore, it prevents needlestick injuries.

[0101] In some embodiments, the hollow needle is a double-headed needle.

[0102] This provides the advantage that two receivers (optionally including a diaphragm) can be easily connected.

[0103] In some embodiments, both the proximal and distal ends of the connector housing include pierceable seals.

[0104] In some embodiments, a double-ended hollow needle is mounted within a housing, wherein when the double-ended hollow needle is biased within the housing, each end of the double-ended hollow needle faces a puncturable seal at a proximal or distal end of the housing.

[0105] This provides the advantage that hollow needles can be kept in a sterile or sterile environment.

[0106] In some embodiments, the first end of the double-ended hollow needle (i.e., the end proximal to the housing) includes a nib-closed end and a port adjacent to the nib-closed end. This end may be referred to as the Whitacre end.

[0107] This provides the advantage that the first end of the double-ended needle can repeatedly puncture resealable puncture-resistant seals (such as seals on connectors, containers, bioreactors, etc.) and ensure the resealability of such seals. Therefore, a sterile environment is maintained.

[0108] In some embodiments, the second end of the double-ended hollow needle (i.e., the distal end adjacent to the housing) includes an open end, such as a beveled open end.

[0109] This provides the advantage that the second end of the double-ended needle can easily pierce a pierceable seal. Specifically, the actuating force required for the second end to pierce a pierceable seal may be relatively small.

[0110] In some embodiments, the connector further includes an actuation mechanism to enable a double-ended hollow needle to pierce pierce a pierceable seal at both the proximal and distal ends.

[0111] In some embodiments, the actuation mechanism includes an outer sleeve configured such that a double-ended hollow needle can pierce a pierceable seal to connect to a first receiver and a second receiver.

[0112] This provides the advantage that, in some embodiments, the hollow needle can be connected to or communicate with a receiver at each end of the housing under sterile conditions.

[0113] 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 may be located on the connector housing. The outer sleeve may be located on the connector housing, between the proximal and distal ends of the connector housing. In some embodiments, the outer sleeve is rotatable. In some embodiments, the outer sleeve may rotate in two directions.

[0114] In some embodiments, the outer sleeve is configured such that at least a portion of rotation of the outer sleeve causes axial translation of the hollow needle to pierce at least one pierceable seal located at an end of the connector housing. For example, this could be a pierceable seal located at either the proximal or distal end of the housing.

[0115] In some embodiments, the outer sleeve is configured such that at least a portion of rotation of the outer sleeve causes axial translation of the punctureable seal to contact the hollow needle, thereby puncturing the punctureable seal located at an end of the connector housing. For example, this could be a punctureable seal located at either the proximal or distal end of the housing.

[0116] In some embodiments, the outer sleeve is configured such that partial rotation of the outer sleeve causes axial translation of the punctureable seals at the proximal and distal ends of the housing to contact the hollow needle, thereby puncturing the punctureable seals at the proximal and distal ends of the connector housing.

[0117] In some embodiments, the outer sleeve is configured such that at least a portion of rotation of the outer sleeve causes axial translation of the hollow needle to pierce each pierceable seal, thereby connecting to or communicating with the first and second receivers.

[0118] In a specific embodiment, the outer sleeve is configured such that at least a portion of the rotation of the outer sleeve causes axial translation of the hollow needle and axial translation of the seal that can be pierced.

[0119] 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 a portion of rotation of the outer sleeve causes axial translation of the hollow needle and the pierceable seal, such that the hollow needle pierces the pierceable seal at the distal end and the pierceable seal of the connector housing.

[0120] Rotating the outer sleeve portion to move the hollow needle or punctureable seal advantageously allows for easy puncture of one or more punctureable seals. Advantageously, this can be done in a fluid-sealing manner. Advantageously, this can be done in a sterilizing manner.

[0121] In some embodiments, the outer sleeve is configured such that at least a portion of rotation of the outer sleeve causes axial translation of the double-ended hollow needle to pierce each pierceable seal, thereby connecting to or communicating with the first and second receivers.

[0122] This offers the advantage that the connector can be manually actuated without the risk of needle prick injury.

[0123] In some embodiments, the outer sleeve is configured such that at least a portion of the axial translation of the outer sleeve causes axial translation of the hollow needle to pierce at least one pierceable seal located at an end of the connector housing. For example, this could be a pierceable seal located at either the proximal or distal end of the housing.

[0124] In some embodiments, the outer sleeve is configured such that at least a portion of the axial translation of the outer sleeve causes axial translation of the pierceable seal to contact the hollow needle, thereby piercing the pierceable seal located at an end of the connector housing. For example, this could be a pierceable seal located at a proximal or distal end of the housing.

[0125] In some embodiments, the outer sleeve is configured such that partial axial translation of the outer sleeve causes axial translation of the punctureable seals at the proximal and distal ends of the housing to contact the hollow needle, thereby puncturing the punctureable seals at the proximal and distal ends of the connector housing.

[0126] In some embodiments, the outer sleeve is configured such that axial translation of at least a portion of the outer sleeve causes axial translation of the hollow needle to pierce each pierceable seal, thereby connecting to or communicating with the first and second receivers.

[0127] In a specific embodiment, the outer sleeve is configured such that at least a portion of the axial translation of the outer sleeve causes axial translation of the hollow needle and axial translation of the piercing seal.

[0128] 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 a portion of the axial translation of the outer sleeve causes axial translation of the hollow needle and the pierceable seal, such that the hollow needle pierces the pierceable seal at the distal end and the pierceable seal of the connector housing.

[0129] Axial translation of the outer sleeve portion to move the hollow needle or punctureable seal advantageously allows for easy puncture of one or more punctureable seals. Furthermore, the axial translation of the outer sleeve ensures that this connector is more suitable for automated processing. Advantageously, this can be performed in a fluid-sealing manner. Advantageously, this can be performed in a sterilizing manner.

[0130] In some embodiments, the outer sleeve is configured such that axial translation of at least a portion of the outer sleeve causes axial translation of the double-ended hollow needle to pierce each pierceable seal, thereby connecting to or communicating with the first and second receivers.

[0131] This offers the advantage that the connector can be manually actuated without the risk of needle prick injury.

[0132] In some embodiments, the connector further includes a releasable attachment mechanism. The connector can be releasably attached to, for example, one or more containers, ports, connectors, or bioreactors. In some embodiments, the releasable attachment mechanism includes threads. In some embodiments, the connector includes threads corresponding to threads on a corresponding element to which the connector can be releasably attached. In some embodiments, the housing includes a releasable connection mechanism. In some embodiments, the housing includes a releasable connection mechanism at its proximal end. In some embodiments, the housing includes a releasable connection mechanism at its distal end. In some embodiments, the connector's outer sleeve includes a releasable attachment mechanism. In some embodiments, the outer sleeve includes a releasable connection mechanism at its proximal end. In some embodiments, the outer sleeve includes a releasable connection mechanism at its distal end.

[0133] In some embodiments, the connector can be rotated to releasably attach it to the corresponding element. In some embodiments, the corresponding element can be rotated to releasably attach it to the connector.

[0134] In some embodiments, the outer sleeve is configured such that it creates a releasable locking engagement between the proximal end of the connector's outer sleeve and a portion of a corresponding receiver (e.g., a second receiver).

[0135] This provides the advantage that users can easily identify whether the connector is correctly connected to the corresponding receiver by touch, sight, or tactile vision.

[0136] In some embodiments, the outer sleeve includes threads. In some embodiments, the outer sleeve includes threads at its proximal end. In some embodiments, the outer sleeve includes threads at its distal end. In some embodiments, the outer sleeve includes threads on its inner surface.

[0137] In some embodiments, the hollow needle is at least partially biased and mounted within the housing.

[0138] This provides the advantage that the hollow needle is designed to be movable, thereby preventing needlestick injuries. Advantageously, the hollow needle can be housed in a safe position, but in use it can be moved to pierce one or more pierceable seals.

[0139] In some embodiments, the double-ended hollow needle is biased in a direction toward the proximal end of the housing by a biasing mechanism. Preferably, the biasing mechanism is a helical spring. The helical spring may extend between a collar operatively coupled to the double-ended hollow needle and the upper housing portion.

[0140] This provides the advantage of enabling sequential puncture of a piercing seal using a single spring.

[0141] In some embodiments, the upper housing portion may include at least one actuable lug. The at least one actuable lug may extend through at least one slot in the outer sleeve of the connector. Actuation of the at least one actuable lug causes the upper housing portion to contract relative to the lower housing portion, thereby causing a hollow needle to pierce a pierceable seal within the lower housing portion. Further actuation causes spring compression, which subsequently causes piercing of the pierceable seal on the housing portion.

[0142] This offers the advantage of easy and precise control over sequential puncture. Therefore, this connector is suitable for automation.

[0143] In some embodiments, the double-ended hollow needle is biased in a direction toward the distal end of the housing by a biasing mechanism. Preferably, the biasing mechanism is a helical spring. The helical spring may extend between a collar operatively coupled to the double-ended hollow needle and the lower housing portion.

[0144] This provides the advantage of enabling sequential puncture of a piercing seal using a single spring.

[0145] In some embodiments, the lower housing portion may include at least one actuable lug. The at least one actuable lug may extend through at least one slot in the outer sleeve of the connector. Actuation of the at least one actuable lug causes the lower housing portion to contract relative to the upper housing portion, thereby causing a hollow needle to pierce a pierceable seal within the lower housing portion. Further actuation causes spring compression, which subsequently causes piercing of the pierceable seal in the lower housing portion.

[0146] This offers the advantage of easy and precise control over sequential puncture. Therefore, this connector is suitable for automation.

[0147] In some embodiments, the double-headed hollow needle is biased in a direction toward the proximal end of the housing by a first biasing mechanism and in a direction toward the distal end of the housing by a second biasing mechanism.

[0148] In some embodiments, a first biasing mechanism provides a first biasing force, and a second biasing mechanism provides a second biasing force, the first biasing force and the second biasing force being approximately equal.

[0149] This provides the advantage that the hollow needle can pierce each septum almost simultaneously.

[0150] In some embodiments, a first biasing mechanism provides a first biasing force, and a second biasing mechanism provides a second biasing force, the first biasing force being greater than the second biasing force.

[0151] This provides the advantage that the hollow needle can first puncture the second septum and then the first septum, thus providing sequential puncture of the septum.

[0152] In some embodiments, a first biasing mechanism provides a first biasing force, and a second biasing mechanism provides a second biasing force greater than the first biasing force.

[0153] This provides the advantage that the hollow needle can first puncture the first septum and then the second septum, thus providing sequential puncture of the septum.

[0154] In some embodiments, the first biasing mechanism includes an elastic or inelastic biasing mechanism.

[0155] In some embodiments, the second biasing mechanism includes an elastic or inelastic biasing mechanism.

[0156] In some embodiments, the first biasing mechanism or the second biasing mechanism or the first biasing mechanism and the second biasing mechanism include a helical spring or a deformable elastic material.

[0157] In some embodiments, the first or second end, or both ends of the double-ended hollow needle, are beveled. That is, in some embodiments, the first or second end, or both ends of the double-ended hollow needle, are beveled.

[0158] This provides the advantage that the fluid can be directly connected to the through-hole of the hollow needle, thereby ensuring that material is completely transferred, for example, from the first receiver to the second receiver. Furthermore, material spillage can be reduced or avoided. Additionally, material (e.g., particles within the fluid) can be guided through the hollow needle, allowing for efficient and effective material transfer, for example, between receivers.

[0159] In some embodiments, the distal end of the housing may be connected to the first receiver. In some embodiments, the proximal end of the housing may be connected to the first receiver.

[0160] In some embodiments, the distal end of the housing includes a threaded portion configured to engage with a corresponding threaded portion of the first receiver.

[0161] In some embodiments, the threaded portion includes a diaphragm seal with a centrally truncated tapered recess.

[0162] This provides the advantage of allowing fluid to be completely transferred from the receiver to the connector, for example. Furthermore, material spillage can be reduced or avoided. Additionally, materials (e.g., solid particles within the fluid) can be guided through the hollow needle, enabling efficient and effective material transfer between, for example, receivers.

[0163] In some embodiments, the threaded portion includes an anti-rotation member.

[0164] In some embodiments, the anti-rotation member includes a plurality of tilted notches configured to engage with a plurality of corresponding notches or slits on the receiver.

[0165] In some embodiments, the puncture-resistant seal at one or each end of the housing includes a puncture-resistant hermetic seal.

[0166] This provides the advantage of maintaining a sterile or sterile environment.

[0167] In some embodiments, a punctureable seal includes a punctureable sealing seal. In some embodiments, a punctureable seal includes a resealable punctureable seal. In some embodiments, a punctureable seal includes a releasable puncture-sealing seal. In some embodiments, a resealable puncture-sealing seal includes a diaphragm seal. In some embodiments, a resealable punctureable seal is self-sealing. In some embodiments, a resealable sealing seal is self-sealing. In some embodiments, a diaphragm seal is self-sealing. In some embodiments, a diaphragm seal is a self-sealing diaphragm seal. In a specific embodiment, a punctureable seal is a self-sealing diaphragm seal. In a specific embodiment, a punctureable seal is a self-sealing sealing seal.

[0168] This provides the advantage that the punctured seal is resealed, allowing for sterile or aseptic connection, disconnection, and reconnection.

[0169] In some embodiments, the puncturable seal includes an annular diaphragm seal. That is, the puncturable seal includes a diaphragm seal formed as an annular space. This annular space may be formed as a raised annular portion surrounding a circular flat base. A hollow needle may be configured to puncture the circular flat base. The raised annular portion may be configured to engage (e.g., face-to-face) with a corresponding puncturable seal (such as another annular diaphragm seal, for example, face-to-face engagement or reception within each other's annular spaces, or a flat diaphragm seal).

[0170] This provides the advantage that the annular protrusion ensures sterility within the closed area to be punctured. Therefore, a sterile or aseptic environment can be maintained.

[0171] In some embodiments, the connector further includes a cover disposed over the pierceable seal at said end or each end of the connector housing.

[0172] In some embodiments, the cover includes a removable sterile paper seal.

[0173] In some embodiments, the connector further includes a sterile sealing system comprising a sterile membrane and a clamping portion, the sterile membrane being disposed above a puncture-resistant seal at said end or each end of the connector housing and operatively coupled to the clamping portion.

[0174] This provides the advantage that, during the handling and / or setting of connectors and / or other components, the sterile membrane ensures a sterile environment at the puncture-resistant seal or each puncture-resistant seal.

[0175] In some embodiments, the clamping portion is slidably operably connected to the connector such that the clamping portion can slide between a first configuration and a second configuration, in which a sterilizing membrane is disposed above the puncture-resistant seal or each puncture-resistant seal, and in the second configuration, the sterilizing membrane is removed from the puncture-resistant seal or each puncture-resistant seal.

[0176] This offers the advantage that the sterilized sealing system can be removed by an automated system before actuation. Therefore, a sterile environment is ensured during use.

[0177] In some embodiments, the clamping portion is slidably connected to the outer sleeve of the connector.

[0178] In a specific embodiment, the clamping portion includes a track configured to be operably received slidably within a track receiving portion of the connector's outer sleeve.

[0179] In a specific embodiment, the clamping portion includes at least one (preferably two) protruding shoulders. In some examples, at least one protruding shoulder is configured to be operatively engaged by a sterile seal actuation mechanism. More specifically, in some embodiments, the sterile seal actuation mechanism is configured to apply a pushing force to said shoulders or each shoulder.

[0180] In a specific embodiment, the clamping portion includes at least a positioning element configured and arranged to engage with a corresponding positioning element of the outer sleeve. In another specific embodiment, the clamping portion includes outwardly extending ribs (e.g., longitudinal ribs) configured and arranged to engage with corresponding ribs or recesses of the outer sleeve (e.g., friction engagement).

[0181] This provides the advantage that the clamping portion and the sterilized sealing system remain in place before being engaged by the sterilized sealing actuation mechanism.

[0182] In some embodiments, the sterilization film includes a sterilization paper seal. Preferably, the sterilization film includes a sterilization polyethylene film.

[0183] In some embodiments, the sterilizing membrane includes at least one fold to form a first surface and a second surface, the first surface being configured to provide a sterilizing seal to the puncture-resistant seal or each puncture-resistant seal, and the second surface being configured to mate with the corresponding sterilizing membrane. Any number of folds may be provided.

[0184] In some embodiments, the connector is a sterile connector.

[0185] In some embodiments, at least one end of the connector is detachably engaged with the receiver by rotating the connector.

[0186] In some embodiments, the first end of the hollow needle may be in fluid connection with the first receiver. That is, a fluid connection may exist between the first end of the hollow needle and the first receiver.

[0187] In some embodiments, the first end of the hollow needle may be in fluid connection with the first receiver.

[0188] In some embodiments, the actuation mechanism acts on the housing or hollow needle to form fluid communication through a punctureable seal.

[0189] In some 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 indicate that the actuation mechanism acts on the corresponding component without any intervening or intermediate parts.

[0190] In some embodiments, the first receiver may include a volume, such as a volume of fluid. In some embodiments, the second receiver may include a volume, such as a volume of fluid.

[0191] The present invention also provides a sterilization sealing system as described herein.

[0192] In some embodiments, the sterilization sealing system may include a clamping portion and a sterilization membrane operatively coupled to the clamping portion.

[0193] In some embodiments, the clamping portion may include a front wall, a rear wall, side walls adjacent to the front and rear walls, and a bottom wall. The clamping portion may include a hollow body defined by the front, rear, side, and bottom walls. The hollow body may include one or more reinforcing ribs extending from an inner surface of the front wall to an inner surface of the rear wall. The front wall may include one or more projecting shoulders configured to engage with a sterilization seal actuation mechanism. The sterilization seal actuation mechanism may be configured to provide a pushing force to the projecting shoulders or each of the projecting shoulders. The bottom wall may include axially projecting members configured and arranged to mate with a receiving member of a corresponding sterilization sealing system, such as a container. The clamping portion may include one or more positioning elements, such as one or more outwardly extending ribs as described above, on one or both side walls.

[0194] In some embodiments, the clamping portion may include one or more rails configured to be slidably received within a corresponding rail receiving portion of the connector.

[0195] In some embodiments, the sterilizing film may include a sterilizing paper seal. Preferably, the sterilizing film includes a sterilized polyethylene film. The sterilizing film may include at least one fold to form a first surface and a second surface, the first surface being configured to sterilize and seal onto a puncture-resistant seal (such as a diaphragm seal), and the second surface being configured to mate with the corresponding sterilizing film.

[0196] The present invention also relates to a method for removing a sterilized sealing system from a connector.

[0197] In the first step, as described herein, a connector and a sterilized sealing system are provided.

[0198] In the second step, a sterilization-sealing actuation mechanism is provided. Optionally, the sterilization actuation mechanism can be integrated into the instrument (such as an incubator or housing).

[0199] In the third step, the sterilization seal actuation mechanism engages with the clamping portion of the sterilization seal system. Optionally, the sterilization seal actuation mechanism engages with one or more shoulders of the clamping portion.

[0200] In the fourth step, the sterilization sealing actuation mechanism applies force to the clamping portion to at least partially remove the sterilized sealing system from the connector. Optionally, the force can be a pushing force or a pulling force.

[0201] In the fifth step, at least partial removal of the clamping portion causes at least partial removal of the sterile membrane from the punctureable seal, thereby exposing at least a portion (preferably all) of the punctureable seal.

[0202] The present invention also provides a system comprising:

[0203] - Connectors as described in this article;

[0204] - A first receiver detachably coupled to one end of the connector, wherein the first receiver is connected to the first end of the hollow needle; and

[0205] - A second receiver detachably connected to one end of the connector, wherein the second receiver is connected to the second end of the hollow needle.

[0206] This offers the advantage that the first receiving element can be connected, disconnected, and reconnected to the second receiving element via a connector. More specifically, the connection, disconnection, and reconnection can be achieved in a sterile or aseptic manner. Furthermore, the system may be more suitable for automated processes and may be easier to handle and use.

[0207] In some embodiments, the first or second receiver includes a pierceable seal that is coaxially aligned with the pierceable seal at said end or each end of the connector housing.

[0208] In some embodiments, the puncture-resistant seal of the first or second receiver or each of the first and second receivers includes a puncture-resistant sealing seal, and wherein the puncture-resistant seal of the housing or each of the puncture-resistant seals includes a puncture-resistant sealing seal.

[0209] In some embodiments, one or more puncture-resistant seals include diaphragm seals. That is, in some embodiments, the puncture-resistant seal of the first receiver or the second receiver or the first receiver and the second receiver, or each puncture-resistant seal, includes a diaphragm seal. Additionally or alternatively, in some embodiments, the puncture-resistant seal of the housing, or each puncture-resistant seal, includes a diaphragm seal.

[0210] In some embodiments, the punctureable seal of the first or second receiver or each punctureable seal includes a sterile sealing system comprising a sterile membrane configured to mate with a sterile membrane of the connector.

[0211] In some embodiments, the system further includes a cell processing platform or a vacuum container.

[0212] In some embodiments, the first receiver may be fluidly connected to the first end of the hollow needle.

[0213] In some embodiments, the second receiver may be fluidly connected to the second end of the hollow needle.

[0214] In some embodiments, the first receiver may include a volume, such as a volume of fluid. In some embodiments, the second receiver may include a volume, such as a volume of fluid.

[0215] The present invention also provides a system comprising:

[0216] - Containers or vacuum containers; and

[0217] - Connectors as described in this article;

[0218] -The container or vacuum container is connected to the distal end of the connector housing, and the first end of the hollow needle is connected to the container or vacuum container.

[0219] This offers the advantage that the container or vacuum container can be connected, disconnected, and reconnected to a second receiving device via a connector. More specifically, the connection, disconnection, and reconnection can be achieved in a sterile or aseptic manner. Furthermore, the system may be more suitable for automated processes and may be easier to handle and use.

[0220] In some embodiments, the receiver, bioreactor, container, or vacuum container includes a volume of fluid.

[0221] In some embodiments, the first end of the hollow needle may be fluidly connected to a container or vacuum container, for example, to a fluid of a certain volume thereof.

[0222] According to another aspect of the invention, a receiver is also provided, which includes a connector as described herein. The receiver may include a container, a vacuum container, the like.

[0223] According to another aspect of the present invention, a method for connecting two receivers is also provided, comprising the following steps:

[0224] Provide connectors as described herein;

[0225] Connect the distal end of the connector housing to the first receiver, such that the first receiver is connected to the first end of the hollow needle;

[0226] The proximal end of the connector housing is detachably connected to a second receiver including a pierceable seal, such that the pierceable seal of the connector is coaxially aligned with the pierceable seal of the second receiver.

[0227] An actuated hollow needle is used to pierce the pierceable seal of the connector housing and pass through the pierceable seal of the second receiver, thereby connecting the first receiver and the second receiver.

[0228] This offers the advantage that the first receiving element can be connected, disconnected, and reconnected to the second receiving element via a connector. More specifically, the connection, disconnection, and reconnection can be performed in a sterile or aseptic manner. Furthermore, this method may be more suitable for automated processes and may be easier to handle and use. The method is simple to use and highly efficient.

[0229] In some embodiments, the step of actuating the hollow needle includes fluidly connecting the first receiver to the second receiver.

[0230] In some embodiments, the step of actuating the hollow needle includes fluidly connecting the first receiver to the second receiver, thereby forming communication between the first receiver and the second receiver.

[0231] In some embodiments, the step of connecting the remote end to the first receiver includes detachably connecting the remote end to the first receiver.

[0232] In some embodiments, the method further includes the step of: rotating the actuation mechanism at least partially so that the hollow needle pierces the pierceable seal of the connector housing and the pierceable seal of the first or second receiver or the first and second receiver.

[0233] In some embodiments, the method further includes the step of: at least partially contracting the upper housing portion of the connector relative to the lower housing portion of the connector along a central longitudinal axis, thereby causing a hollow needle to pierce the pierceable seal of the connector housing and the pierceable seal of the first receiver.

[0234] In some embodiments, the step of at least partially retracting the upper housing portion includes: engaging one or more actuated lugs of the upper housing portion with an actuation mechanism; and actuating the actuated lugs or each actuated lug of the upper housing portion to retract the upper housing portion relative to the lower housing portion of the connector along a central longitudinal axis.

[0235] In some embodiments, the step of at least partially retracting the upper portion of the connector results in a hollow needle piercing through the pierceable sealing seal of the housing portion.

[0236] In some embodiments, the method further includes the step of: axially translating a hollow needle at least partially along its central longitudinal direction toward the proximal end of the connector, thereby causing the hollow needle to pierce a pierceable seal of the connector housing and a pierceable seal of the second receiver.

[0237] In some embodiments, the step of at least partially axially translating the hollow needle includes engaging one or more actuated lugs of a collar operably coupled to the hollow needle with an actuation mechanism, and actuating the actuated lugs or each actuated lug of the collar to axially translate the collar and the hollow needle toward the proximal end of the connector.

[0238] In some embodiments, the step of axially translating the hollow needle at least partially causes the hollow needle to pierce the pierceable sealing seal of the lower housing portion.

[0239] In some embodiments, the punctureable seal or each punctureable seal is a punctureable tight seal.

[0240] In some embodiments, the puncture-resistant seal or each puncture-resistant seal includes a diaphragm seal.

[0241] According to another aspect of the invention, a connector as described herein and an actuation system configured to actuate the connector are provided.

[0242] In some embodiments, the actuation system is configured to actuate the pin safety feature of the connector, with the actuation mechanism acting on the hollow needle to cause it to pierce the pierceable seal or each pierceable seal and / or the sterile sealing system as described herein. The actuation system may be located externally to the connector. The actuation system may be incorporated into an instrument (such as an incubator).

[0243] According to another aspect of the present invention, a sterilization connection arrangement is also provided, comprising:

[0244] - A first sterilized sealing system, comprising a first clamping portion and a first sterilized membrane, the first clamping portion including a first connecting element, the first sterilized membrane being operatively coupled to the first clamping portion, the first sterilized membrane being disposed above at least a portion of a first punctureable seal;

[0245] - A second sterilization sealing system comprising a second clamping portion and a second sterilization membrane, the second clamping portion including a second connecting element configured to be operatively coupled to a first connecting element, the second sterilization membrane being operatively coupled to the second clamping portion and configured to be operatively coupled to the first sterilization membrane, the second sterilization membrane being disposed above at least a portion of a second punctureable seal.

[0246] This provides the advantage that the two fluid volumes can be connected and disconnected under sterile conditions. Specifically, this provides the advantage that the two fluid volumes can be connected and disconnected under sterile conditions in a manner suitable for automation (e.g., suitable for use in automated cell and / or gene therapy manufacturing processes).

[0247] In some embodiments, the first sterilization membrane and / or the second sterilization membrane are disposed above most or all of their respective first punctureable seal and / or second punctureable seal.

[0248] In some embodiments, the first sterilized sealing system and / or the second sterilized sealing system include a sterilized sealing system for the connector, wherein a corresponding first punctureable seal and / or second punctureable seal is formed as part of the connector. The connector may be a connector as described herein. The first sterilized sealing system and / or the second sterilized sealing system may be a sterilized sealing system for the connector as described herein.

[0249] In some embodiments, the first sterilized sealing system and / or the second sterilized sealing system include sterilized sealing systems for containers, bioreactors, interface plates, etc., with the corresponding first puncture-resistant seal and / or second puncture-resistant seal formed as part of the container, bioreactor, interface plate, etc.

[0250] In some embodiments, the first punctureable seal and / or the second punctureable seal includes seals as described herein, such as hermetic seals, resealable seals, diaphragm seals, etc.

[0251] In some embodiments, the first sterilized sealing system and / or the second sterilized sealing system are configured to be actuated by an actuation system. In some embodiments, actuation of the first sterilized sealing system and / or the second sterilized sealing system causes the first sterilized membrane and / or the second sterilized membrane to be removed from the corresponding first punctureable seal and / or second punctureable seal.

[0252] In some embodiments, a first clamping portion is slidably operably coupled to a portion of a component in which a first puncturable seal is disposed. In some embodiments, a second clamping portion is slidably operably coupled to a portion of a component in which a second puncturable seal is disposed. In a particular embodiment, a first sterilization sealing system and / or a second sterilization sealing system are arranged to be actuated to slidably move the first clamping portion and the second clamping portion, thereby removing a first sterilized film and a second sterilized film from corresponding first and second puncturable seals. In some embodiments, the first sterilization sealing system and / or the second sterilization sealing system are arranged to be actuated between a first configuration and a second configuration, in which a corresponding sterilized film is at least partially disposed above its corresponding puncturable seal, and in a second configuration, a corresponding sterilized film is removed from its corresponding puncturable seal.

[0253] According to another aspect of the present invention, a method for operating a sterilization connection arrangement is provided, comprising:

[0254] - Provide a first sterilized sealing system, the first sterilized sealing system including a first clamping portion and a first sterilized membrane, the first clamping portion including a first coupling element, the first sterilized membrane being operatively coupled to the first clamping portion, the first sterilized membrane being positioned above at least a portion of a first puncturable seal;

[0255] - Provide a second sterilization sealing system, the second sterilization sealing system including a second clamping portion and a second sterilization membrane, the second clamping portion including a second coupling element, the second sterilization membrane being operatively coupled to the second clamping portion, the second sterilization membrane being positioned above at least a portion of a second punctureable seal;

[0256] - Operablely connect the first connecting element to the second connecting element;

[0257] - Operablely attach the first sterilization membrane to the second sterilization membrane;

[0258] -Actuate the first sterilized sealing system and / or the second sterilized sealing system to remove the first sterilized film from a portion of the first puncturable seal and remove the second sterilized film from a portion of the second puncturable seal, so as to attach the outer surface of the first puncturable seal to the outer surface of the second puncturable seal under sterilized conditions.

[0259] This provides the advantage that the two fluid volumes can be connected and disconnected under sterile conditions. Specifically, this provides the advantage that the two fluid volumes can be connected under sterile conditions in a manner suitable for automation (e.g., suitable for use in automated cell and / or gene therapy manufacturing processes).

[0260] In some embodiments, the outer surface of the first punctureable seal is pushed into a sterile face-to-face engagement with the outer surface of the second punctureable seal.

[0261] In some embodiments, the method further includes treating a first sterilized sealing system and / or a second sterilized sealing system.

[0262] In some embodiments, the method further includes providing a fluid passage through a first puncturable seal and a second puncturable seal. The fluid passage may be provided by the connector described herein.

[0263] According to another aspect of the invention, a sterile or sterilized connector is provided for introducing material into or removing material from at least one receiver, the connector comprising:

[0264] - A housing extending between a distal end and a proximal end, the housing including a first puncturable seal at the distal end and a second puncturable seal at the proximal end;

[0265] - A hollow needle installed within a housing between a distal and proximal end, the first end of the hollow needle facing a first pierceable seal and connectable to a first receiver, and the second end of the hollow needle facing a second pierceable seal and connectable to a second receiver; and

[0266] - An actuation mechanism that acts on the housing or hollow needle to enable the hollow needle to pierce the first and second pierceable seals, thereby forming a connection through the pierceable seals, allowing material to be transferred through the sterile connector.

[0267] In some embodiments, a sterile connector or a connector according to any of the foregoing aspects forms a sterile or hermetically sealed connection through a punctureable seal, enabling material to be transferred sterilely or hermetically through the sterile connector or the connector.

[0268] In other words, the connection formed by the puncturable seal or the seal can be sterile (i.e., sterilized) or closed (i.e., fluid-tight). Therefore, a sterile or closed environment is ensured for material transfer. In some embodiments, the connection is sterile and closed.

[0269] According to another aspect of the invention, a sterile packaging or sterile container is provided, which includes a connector as described herein or a sterile connector.

[0270] That is, a sterile or sterilized package or container is provided, wherein the connector or sterile connector is packaged. The package or container may take the form of a pouch, a receiving item, a box, a bag, etc. The package or container and / or the connector or sterile connector may be sterilized before or after being packaged into the package or container. In some embodiments, the package or container, which optionally includes the connector or sterile connector, is subjected to gamma radiation before or after the connector or sterile connector is packaged into the package or container.

[0271] This offers the advantage of providing users with a completely sterile kit, thus providing readily available connectors in biomaterial handling systems.

[0272] As used herein, the terms “sterile attachment,” “sterilely sealed attachment,” or “sterilely sealed attachment” are used to describe sterile attachments. This includes attachments that are tight enough to substantially prevent the passage of microorganisms.

[0273] As used herein, the term "axial translation" describes movement parallel to or substantially parallel to the longitudinal axis. When used to describe the axial translation of a pin, this describes the possible movement of the pin parallel to the longitudinal axis of the pin and the connector. When the term is used to describe the axial translation of the outer sleeve, housing, or other components, this describes the movement of the outer sleeve, housing, or other components in a plane parallel to the longitudinal axis of the connector. The longitudinal axis of the connector extends between the proximal and distal ends of the connector. The longitudinal axis of the connector also extends between the proximal and distal ends of the connector housing.

[0274] As used herein, the terms “shrink” or “retractable” are used to describe a reduction in length or a movement that reduces length. As used herein, the terms “shrink” and “retractable” also include folding, sliding, turning, and rotation that may result in a reduction in length or height. For example, shrinkage of a housing or outer sleeve may include rotation of the housing or outer sleeve such that the height or length of the housing or outer sleeve is reduced. The terms “shrink” and “retractable” do not necessarily mean folding. The terms “shrink” and “retractable” do not necessarily mean that the reduction in height or length is irreversible. As used herein, the terms “retractable” and “shrink” also include partial shrinkage or contraction.

[0275] As used herein, the term "receiving vessel" is used to describe any vessel or container capable of containing material (e.g., solid or fluid). As used herein, the term "receiving vessel" includes both hard and soft receiving vessels, such as sacks, bags, corrugated pipes, bioreactors, or vacuum containers.

[0276] As used in this article, the term "double-ended hollow needle" is used to describe a hollow needle whose ends are both pointed or sharp.

[0277] As used herein, the term "material" is used to describe any material. The term "material" includes one or more solids or one or more fluids. The term "material" also includes gases, liquids, solutions, pastes, gels, etc.

[0278] As used herein, the term "fluid" is used to describe gases and liquids (including solutions), but also includes particulate solids (including powders). Particulate solids do not need to be in solution. Similarly, particulate solids can be in solution, for example, particulate solids can be suspended in liquid.

[0279] As used herein, the term "sealing seal" is used to describe a seal that is impermeable to fluids.

[0280] As used herein, the term "partial rotation" is used to describe partial movement in a rotational manner and direction. It can include all amounts or distances of rotation and any amount or distance. Specifically, in this document it will include rotation to a desired degree of rotation, for example, to perform a function (e.g., puncture a seal) or to releasably attach two items.

[0281] As used herein, the term "punctureable seal" is used to describe a seal that can be punctured, for example, by a needle.

[0282] The term "puncture-resistant seal" is used to describe a seal that is puncture-resistant but also resealable because the seal is able to reseal automatically once the cause of the puncture (e.g., a hollow needle) is removed. As used herein, the term "puncture-resistant seal" can also mean "puncture-resistant seal that can be resealed."

[0283] As used herein, the term “puncture” is used to describe the puncture of a material such that a puncturing element (e.g., a hollow needle) protrudes at least partially through the material.

[0284] As used herein, the term “self-sealing” for seals is used to describe a seal that can automatically reseal itself after the cause of the puncture or rupture has been removed. Therefore, the seal is constructed and made of a material capable of closing and resealing an opening or rupture.

[0285] As used herein, "diaphragm seal" is used to describe a seal that includes a material that provides a sterile seal, but the material may also be punctured, for example, by a needle.

[0286] As used herein, the term "self-sealing sterile seal" is used to describe a sterile seal that can be resealed after, for example, a hollow needle puncture or penetration to provide a sterile seal again.

[0287] Any features or steps described herein in connection with a connector or a method for manufacturing a connector, an apparatus (or system) for manufacturing a connector, components for such connectors, or a kit of components of such manufacturing apparatus including a connector or a method for manufacturing a connector, any apparatus (including a system) for manufacturing connector components, or a kit of components of such manufacturing apparatus including multiple manufacturing apparatuses suitable for manufacturing a connector or its connector components, are equally applicable to any connector described herein, any method for manufacturing connector components, apparatus (including a system) for manufacturing connector components, components thereof, or any other embodiment, aspect, or example of such manufacturing apparatus including multiple manufacturing apparatuses suitable for manufacturing a connector.

[0288] Referring now to the accompanying drawings, which depict one or more embodiments described in this disclosure. However, it should be understood that other embodiments not shown in the drawings also fall within the scope of this disclosure. Similar numbers used in the drawings refer to similar components, steps, etc. However, it should be understood that the use of numbers to designate parts in a given drawing is not intended to limit the designation of parts with the same numbers in another drawing. Furthermore, the use of different numbers to designate parts in different drawings does not mean that parts with different numbers cannot be the same as or similar to parts with other numbers. These drawings are presented for illustrative purposes and not for limiting purposes. The schematic diagrams presented in the drawings are not necessarily drawn to scale. Attached Figure Description

[0289] Now, by way of example only, exemplary embodiments of the invention will be described below with reference to the accompanying drawings, wherein:

[0290] Figure 1 A perspective view of a connector according to an embodiment of the present invention is shown, the connector including a removable sterile paper seal;

[0291] Figure 2 It shows Figure 1 A cross-sectional view of the connector;

[0292] Figure 3 It shows Figure 1 A cross-sectional view of the connector when connected to the first and second containers;

[0293] Figure 4 It shows Figure 3 Another sectional view;

[0294] Figure 5 This shows the process before assembly into the second container. Figure 1 A cross-sectional view of the connector when it is connected to the first container and the second container having another removable sterile paper seal;

[0295] Figure 6 It shows Figure 1 A cross-sectional view of the connector when connected to the first and second containers;

[0296] Figure 7 It shows Figure 1 A cross-sectional view of the connector when connected to the first and second containers, with the removable sterile paper seal removed;

[0297] Figure 8 It shows Figure 1 A cross-sectional view of the connector when connected to the first and second containers, wherein the hollow needle is connected to the second container;

[0298] Figure 9 It shows Figure 1A cross-sectional view of the connector when connected to the first and second containers, wherein the hollow needle is connected to the first and second containers;

[0299] Figure 10 It shows Figure 9 Another view, in which fluid can be transferred between the first and second containers;

[0300] Figure 11 It shows Figure 1 A cross-sectional view of the connector when it is connected to the first and second containers after the fluid connection is completed;

[0301] Figure 12 A side view of a connector according to another embodiment of the present invention when connected to a first container and a second container is shown;

[0302] Figure 13 It shows Figure 12 A sectional view;

[0303] Figure 14 It shows Figure 12 A cross-sectional view of the connector when it is connected to the first and second containers before fluid connection is made;

[0304] Figure 15 It shows Figure 12 A cross-sectional view showing the hollow needle connected to the second container;

[0305] Figure 16 It shows Figure 12 A cross-sectional view showing the hollow needle connected to the first and second containers;

[0306] Figure 17 It shows Figure 12 A cross-sectional view of the connector when it is connected to the first and second containers after the fluid connection is completed;

[0307] Figure 18 This illustrates the process when the connector and the first container are removed from the second container. Figure 12 A sectional view;

[0308] Figure 19 A perspective view of a connector according to another embodiment of the present invention is shown;

[0309] Figure 20 It shows Figure 19 A cross-sectional view of the connector;

[0310] Figure 21 It shows Figure 19 (a) perspective view, (b) top view, (c) side view, (d) sectional view and (e) bottom view of the lower housing portion of the connector;

[0311] Figure 22 It shows Figure 19 (a) perspective view, (b) top view, (c) side view, (d) sectional view and (e) bottom view of the upper housing portion of the connector;

[0312] Figure 23 It shows Figure 19 (a) perspective view, (b) top view, (c) side view, (d) sectional view and (e) bottom view of the outer sleeve of the connector;

[0313] Figure 24 It shows the use of with Figure 19 (a) perspective view, (b) top view, (c) side view, (d) sectional view and (e) bottom view of a sterilized sealing system used together with connectors;

[0314] Figure 25 It shows Figure 19 (a) perspective view, (b) top view, (c) side view, (d) sectional view and (e) bottom view of the connector's collar;

[0315] Figure 26 It shows Figure 19 (a) perspective view, (b) top view, (c) side view, (d) sectional view and (e) bottom view of the connector's protective cover;

[0316] Figure 27 It shows Figure 19 The connector is (a) before actuation, (b) after sterilization connection with the first fluid volume, (c) after sterilization connection with the second fluid volume, (d) after sterilization disconnection with the second fluid volume, and (e) after sterilization disconnection with the first fluid volume;

[0317] Figure 28 A perspective view of a connector according to another embodiment of the present invention is shown;

[0318] Figure 29 It shows Figure 28 A cross-sectional view of the connector;

[0319] Figure 30 It shows Figure 28 The connector is (a) before actuation, (b) after sterilization connection with the first fluid volume, (c) after sterilization connection with the second fluid volume, (d) after sterilization disconnection with the second fluid volume, and (e) after sterilization disconnection with the first fluid volume;

[0320] Figure 31 A perspective view of a connector according to another embodiment of the present invention is shown;

[0321] Figure 32 It shows Figure 31 A cross-sectional view of the connector;

[0322] Figure 33 It shows Figure 31 Another cross-sectional view of the connector;

[0323] Figure 34 It shows Figure 31 Top view of the connector;

[0324] Figure 35 It shows Figure 31 The connector is (a) before actuation, (b) after sterilization connection with the first fluid volume, (c) after sterilization connection with the second fluid volume, (d) after sterilization disconnection with the second fluid volume, and (e) after sterilization disconnection with the first fluid volume;

[0325] Figure 36 A perspective view of a connector according to another embodiment of the present invention is shown;

[0326] Figure 37 It shows Figure 36 A cross-sectional view of the connector;

[0327] Figure 38 It shows Figure 36 Top view of the connector;

[0328] Figure 39 It shows Figure 36 A bottom view of the connector;

[0329] Figure 40 It shows Figure 36 (a) perspective view, (b) top view, (c) side view, (d) bottom view and (e) sectional view of the lower housing portion of the connector;

[0330] Figure 41 It shows Figure 36 (a) perspective view, (b) top view, (c) side view, (d) bottom view and (e) sectional view of the upper housing portion of the connector;

[0331] Figure 42 It shows Figure 36 (a) perspective view, (b) top view, (c) side view, (d) bottom view and (e) sectional view of the connector's collar and hollow pin;

[0332] Figure 43 It shows Figure 36 (a) perspective view, (b) top view, (c) side view, (d) bottom view and (e) sectional view of the connector's protective cover;

[0333] Figure 44 It shows Figure 36 (a) perspective view of a portion of the outer sleeve of the connector, (b) perspective view of another portion of the outer sleeve, (c) bottom view of a portion of the outer sleeve, (d) side view of a portion of the outer sleeve, (e) top view of a portion of the outer sleeve, and (f) another side view of a portion of the outer sleeve.

[0334] Figure 45 It shows Figure 36 (a) perspective view, (b) top view, (c) side view, (d) bottom view and (e) sectional view of the internal components of the connector;

[0335] Figure 46 It shows the outer sleeve. Figure 45 (a) top view, (b) side view, (c) bottom view and (d) sectional view of the component;

[0336] Figure 47 It shows the use of with Figure 36 (a) perspective view, (b) top view, (c) side view, (d) bottom view, and (e) sectional view of a sterilized sealing system used with connectors, and with Figure 36 (f) Bottom view of the sterilization sealing system connected to the connector;

[0337] Figure 48 The following are shown: (a) a perspective view of the transport cover and the transport cap; (b) a side view of the transport cover and the transport cap; and (c) a side view of the transport cover and the transport cap. Figure 36 A cross-sectional view of a connector having a transport cover and a transport cap attached thereto;

[0338] Figure 49 The diagram shows (a) a perspective view of the receiving mechanism, (b) a top view of the receiving mechanism, (c) a bottom view of the receiving mechanism, and (d) a view of the receiving mechanism containing... Figure 36 A perspective view of the connector's housing mechanism;

[0339] Figure 50 The following are shown: (a) the containment mechanism, interface plate, bioreactor, and [other components] in use. Figure 36 (a) A perspective view of the connector and (b) the housing mechanism, interface board, and [other components] in use. Figure 36 A cross-sectional view of the connector;

[0340] Figure 51 A perspective view (a) and a cross-sectional view of a connector according to another embodiment of the present invention are shown;

[0341] Figure 52 It shows Figure 51 (a) perspective view and (b) sectional view of the outer sleeve of the connector;

[0342] Figure 53 It shows the use of in Figure 51 (a) perspective view, (b) bottom view and (c) top view of the sterilized sealing system used in the connector;

[0343] Figure 54 It shows the attachment Figure 53 The sterilization sealing system Figure 52 (a) perspective view and (b) side view of the outer sleeve;

[0344] Figure 55 It shows Figure 51 (a) perspective view, (b) top view and (c) side view of the connector's collar;

[0345] Figure 56 It shows (a) for use in Figure 51 Perspective view of the protective cover used in the connector. Figure 51 (b) sectional view and (c) perspective view of the connector's protective cover and collar;

[0346] Figure 57 It shows Figure 51 (a) perspective view, (b) side view and (c) bottom view of the lower housing portion of the connector;

[0347] Figure 58 It shows Figure 51 (a) perspective view, (b) side view, (c) bottom view and (d) top view of the upper housing portion of the connector;

[0348] Figure 59 It shows Figure 51 A perspective view of the first step in assembling the connector;

[0349] Figure 60 It shows Figure 51 (a) perspective view and (b) side view of the second step of connector assembly;

[0350] Figure 61 It shows Figure 51 (a) perspective view and (b) side view of the third step of connector assembly;

[0351] Figure 62 It shows Figure 51 (a) perspective view and (b) side view of the fourth step of connector assembly;

[0352] Figure 63 A connector according to another embodiment of the present invention is shown;

[0353] Figure 64 It shows Figure 63(a) perspective view, (b) rear view and (c) front view of a portion of the outer sleeve of the connector;

[0354] Figure 65 It shows Figure 63 (a) perspective view, (b) rear view and (c) front view of another part of the outer sleeve of the connector;

[0355] Figure 66 It shows Figure 63 (a) perspective view, (b) side view and (c) other side view of the upper housing portion of the connector;

[0356] Figure 67 It shows Figure 63 (a) Top view and (b) Bottom view of the upper housing portion of the connector;

[0357] Figure 68 It shows (a) Figure 63 (a) A perspective view of another embodiment of the upper housing portion of the connector and (b) a perspective view of the upper housing portion of (a) assembled to the outer sleeve;

[0358] Figure 69 It shows Figure 63 (a) perspective view, (b) front view and (c) side view of the lower housing portion of the connector;

[0359] Figure 70 It shows Figure 63 (a) Top view and (b) Bottom view of the lower housing portion of the connector;

[0360] Figure 71 It shows (a) Figure 63 A perspective view of another embodiment of the lower housing portion of the connector and a perspective view of (b) the lower housing portion assembled to the outer sleeve;

[0361] Figure 72 It shows Figure 63 (a) perspective view, (b) side view and (c) other side view of the connector's collar;

[0362] Figure 73 It shows Figure 63 (a) a side view and (b) a perspective view of another embodiment of the hollow pin and collar of the connector;

[0363] Figure 74 It shows Figure 63 (a) A perspective view of the first protective cover and (b) a perspective view of the second protective cover of the connector;

[0364] Figure 75 It shows the use of in Figure 63(a) perspective view, (b) front view and (c) rear view of the clamping portion of the sterilized sealing system used in the connector;

[0365] Figure 76 It shows Figure 75 (a) Top view and (b) Bottom view of the clamping part;

[0366] Figure 77 It shows (a) Figure 75 (a) A perspective view of another embodiment of the clamping portion and (b) a bottom view of the clamping portion assembled to the outer sleeve (a);

[0367] Figure 78 It shows the use of in Figure 63 (a) perspective view, (b) top view and (c) bottom view of the transport cover used in the connector;

[0368] Figure 79 It shows Figure 63 Perspective views of the connector assembly in steps (a) first step, (b) second step, (c) third step, (d) fourth step, (e) fifth step, (f) sixth step, (g) seventh step, (h) eighth step, (i) ninth step, and (j) tenth step; and

[0369] Figure 80 It is shown that it is arranged with Figure 63 A perspective view of an embodiment of an interface board for sterilization connection of connectors. Detailed Implementation

[0370] The exemplary embodiments described below with reference to the accompanying drawings relate to a connector for introducing material into or removing material from at least one receiver. Specifically, some embodiments relate to a connector as a sterile connector. Note that the terms "sterile" and "aseptic" are used interchangeably throughout the text. References to fluids in the detailed description are not intended to limit the scope of protection to these materials. As those skilled in the art will recognize, fluids as described herein are merely examples of suitable materials for use with the connector. Similarly, references to containers, vacuum containers, etc., may be made; however, these references in the detailed description are not intended to limit the scope of protection to such receivers or vessels. As those skilled in the art will recognize, containers, vacuum containers, etc., are described herein only as examples of suitable receivers.

[0371] The use of certain terms in the following description is for convenience only and not for limitation. The terms “upper” and “lower” in the accompanying drawings indicate a direction of reference and are relative to the parts described during assembly and installation. The terms “inner,” “inward,” “outer,” and “outward” refer to directions toward and away from the designated centerline or geometric center (e.g., central axis) of the described element, respectively, their specific meanings being self-evident in the context of the specification. Furthermore, the terms “proximal” (i.e., closer) and “farthest” (i.e., away) indicate positions relative to an axis or attachment point.

[0372] Furthermore, as used herein, the terms “connection,” “fixed connection,” “joint,” etc., are intended to include both direct connections between two components (without any other components in between) and indirect connections between components (with one or more other components in between). The terms include those specifically mentioned above, their derivatives, and words with similar meanings.

[0373] Furthermore, unless otherwise stated, the use of ordinal adjectives (such as "first," "second," "third," etc.) merely indicates reference to different instances of similar objects and does not imply that the objects described must be in a given order in time, space, sequence, or any other way. Similar reference numerals are always used to depict similar features.

[0374] like Figure 1 and Figure 2 As shown, a connector 100 for connecting two fluid volumes is provided. The connector 100 includes a housing 102 comprising 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 is axially movable or sliding relative to the lower housing portion 102b, as will be further described below.

[0375] The housing 102 includes a threaded portion 107 at its distal end 104 for connection to a corresponding threaded portion 208 of the first container 200 including the first fluid volume 202 (see [link]). Figure 3 and Figure 5 On the above. Those skilled in the art will appreciate that the housing 102 may not have the threaded portion 107, but rather another suitable connection mechanism for attachment to a portion of the container. Furthermore, the first container can be directly attached to the distal end 104 by any suitable mechanism; for example, the container can be pre-attached or sealed, for example, by adhesives. In some embodiments, the container is manufactured to include a connector according to the invention.

[0376] In this embodiment, the connector 100 includes a first diaphragm seal 108 disposed at a distal end 104 of a housing 102 and a second diaphragm seal 110 disposed at a proximal end 106 of the housing 102. The first diaphragm seal 108 includes a substantially planar (i.e., flat) punctureable surface facing outwards at the distal end 104. The second diaphragm seal 110 includes a generally annular portion extending outwards at the proximal end 106, which surrounds the substantially planar (i.e., flat) punctureable surface facing outwards at the proximal end 106. The housing 102 further includes a hollow needle 112 biasedly mounted within the housing 102. The hollow needle 112 is generally coaxially aligned with a longitudinal axis. The hollow needle 112 includes a first end 114 facing the first diaphragm seal 108 and a second end 116 facing the second diaphragm seal 110. The first end 114 is configured to pierce the first diaphragm seal 108 in use, and the second end 116 is configured to pierce the second diaphragm seal 110 in use. The first diaphragm seal 108, the second diaphragm seal 110, or either the first diaphragm seal 108 or the second diaphragm seal 110 may optionally be provided with a removable sterile paper seal 111.

[0377] The hollow needle 112 is mounted within the housing 102 via 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 fixedly mounted (so that the hollow needle does not move), and the housing 102 may move about the hollow needle 112. Further reference Figure 3 The collar 118 includes an upper surface 124 and a lower surface 128, the upper surface facing the inner surface 126 of the distal end 104 of the housing 102, and the lower surface facing the inner surface 130 of the proximal end 106 of the housing 102. The collar 118 engages with the hollow needle 112 via any suitable engagement mechanism (e.g., a friction-fit through-hole as shown). A first spring 120 extends from the inner surface 126 of the distal end 104 of the housing 102 to the upper surface 124 of the collar 118. A second spring 122 extends from the inner surface 130 of the proximal end 106 of the housing 102 to the lower surface 128 of the collar 118. In this way, the first spring 120 provides a first biasing force F1 to the hollow needle 112 in the direction toward the proximal end 106 of the housing 102 via the collar 118, and the second spring 122 provides a second biasing force F2 to the hollow needle 112 in the direction toward the distal end 104 of the housing 102 via the collar 118.

[0378] like Figure 3As best illustrated, the diameter of the wire in the first helical spring 120 (i.e., the thickness of the material forming the helical spring) is greater than the diameter of the wire in the second helical spring 122. In this way, the biasing force applied by the first spring 120 is greater than the biasing force applied by the second spring 122. That is, the first biasing force F1 is greater than the second biasing force F2. In other examples, the outer diameter of the first spring 120 (i.e., the diameter of the spring itself) may be greater than the outer diameter of the second spring 122, so that the first biasing force F1 provided by the first spring is greater than the second biasing force F2. Alternatively, in other embodiments, the first spring 120 and the second spring 122 may have equal biasing forces, or the second spring 122 may have a greater biasing force than the first spring 120. In an example where one of the first and second biasing forces is greater than the other (i.e., unequal), the hollow needle 112 is made to first pierce one of the first diaphragm seal 108 and the second diaphragm seal 110, and then pierce the other of the first diaphragm seal 108 and the second diaphragm seal 110. In this way, unequal first and second bias forces provide for the sequential puncture of the diaphragm, as described in more detail below.

[0379] As those skilled in the art will understand, other suitable biasing mechanisms can be used. In some examples, the helical springs or helical springs 120, 122 may be elastic or inelastic. In other examples, a deformable material or another type of spring may be provided instead of one or both helical springs 120, 122, such as an elastic material. The deformable material or each deformable material may be provided in the form of a bellows. The deformable material or each deformable material may be elastic or inelastic. Any combination may be used.

[0380] refer to Figures 1 to 3The connector 102 further includes an actuation mechanism 132 for causing the hollow needle 112 to pierce the diaphragm seals 108, 110. The actuation mechanism 132 includes an outer sleeve 134 arranged to retract 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 track 136 arranged to engage a protrusion (not shown) on the upper housing portion 102a. When the outer sleeve 134 is rotated, the protrusion is guided by the track 136, thereby translating the rotation of the outer sleeve 132 into an axial translation (i.e., retraction) of the upper housing portion 102a. As further described below, this causes the springs 120, 122 to compress and causes the hollow needle 112 to pierce the diaphragm seals 108, 110. The outer sleeve 134 may 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 may receive one or more protrusions 310 via a snap-fit ​​mechanism. The outer sleeve 134 may also include one or more openings 140 that allow a user to release the legs or each leg 308 of the second container 300, thereby releasing the releasable locking engagement.

[0381] refer to Figures 1 to 11 ,in particular Figures 3 to 11 The method of using connector 100 is now described. Connector 100 is first coupled to a first container 200 containing a first fluid volume 202 and a diaphragm seal 204. Diaphragm seal 204 may include a centrally frustoconical recess 206. The first container 200 may be in the form of a bellows, i.e., a container with walls that are corrugated or Z-folded at a distal end, a proximal end, and therebetween. In other examples, the first container 200 may be in the form of a vacuum container or a lid, i.e., an interface plate between connector 100, the first container 200, and another container.

[0382] The first container 200 can be detachably or permanently coupled to the distal end 104 of the connector 100. In the depicted example, the first container 200 includes a threaded portion 208 that threadedly engages with a threaded portion 107 at the distal end 104 of the housing 102 of the connector 100. In this way, the diaphragm seal 204 of the first container 200 abuts the first diaphragm seal 108 of the connector. In some examples, the first container 200 may include a removable sterile paper seal (not shown) disposed above the diaphragm seal 204, which is arranged to engage with a removable sterile paper seal (not shown) disposed above the first diaphragm 108 of the connector. In such an example, once a connection is formed between the connector 100 and the second container 200, the sterile paper seal can be removed by pulling a tab on each corresponding sterile paper seal, thereby providing sterile abutment between the diaphragm seal 204 of the first container 200 and the first diaphragm seal 108 of the connector.

[0383] Once connector 100 is attached to the first container 200, it can then be attached to a second container 300 containing a second fluid volume 302. The second container 300 can take the form of a container or bellows, a lid (i.e., an interface plate between connector 100, the first container 200, or another container) as described above. In the depicted example, the second container 300 takes the form of a lid that is attached to or can be attached to a container (e.g., a bioreactor (not shown)). The second container 300 includes a diaphragm seal 304 with a removable sterile paper seal 306 disposed above it. Furthermore, the second container 300 includes a plurality of legs 308, each leg 308 having a protrusion 310.

[0384] Connector 100 is detachably coupled to the second container 300 by snapping in the protrusions 310 on each leg 308 into the circumferential grooves 138 of the outer sleeve 134. One or more legs 308 are exposed through the orifices 140 of the outer sleeve 134, allowing the protrusions 310 to be released from the circumferential grooves 138 after use. During the detachable coupling of the second container 300 to connector 100, the removable sterile paper seal 111 of connector 100 engages 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 tabs or handles of each sterile paper seal 111, 306. In this way, sterile abutment is provided between the second diaphragm seal 110 of connector 100 and the diaphragm seal 304 of the second container 300, as Figure 6 As shown. Then, connector 100 is ready to provide fluid communication between the first fluid volume 202 and the second fluid volume 302.

[0385] For details, please refer to the following: Figures 8 to 11 The outer sleeve 134 of connector 100 rotates about the longitudinal axis of housing 100. This rotation causes the upper housing portion 102a to contract axially toward and within the lower housing portion 102b. In this way, when the biasing force of the first spring 120 is greater than that of the second spring 122, the hollow needle 112 first pierces the second diaphragm seal 110. In other words, the second spring 122 is compressed more than the first spring 120, or the second spring is more easily compressed than the first spring, thus allowing the hollow needle 112 to first pierce the second diaphragm seal 110 of connector 100. Continued rotation of the outer sleeve 134 causes the second end 116 of the hollow needle 112 to pierce the second diaphragm seal 110 of connector 100, enter the diaphragm seal 304 of the second container 300, and subsequently pass through it. In this way, the second end 116 of the hollow needle 112 is in fluid connection with the second container 300.

[0386] As the outer sleeve 134 of connector 100 continues to rotate about the longitudinal axis of housing 100, the hollow needle 112 pierces the first diaphragm seal 108 as the first spring 120 is compressed. In other words, since the second spring 122 is already fully compressed by means of a different biasing force, the first end 114 of the hollow needle 112 is forced through the first diaphragm seal 108 when the first spring 120 is forcibly compressed. The continued rotation of the outer sleeve 134 causes the first end 114 of the hollow needle 112 to pierce the first diaphragm seal 108 of connector 100, enter the diaphragm seal 204 of the first container 200, and subsequently pass through it. In this way, the first end 114 of the hollow needle 112 is fluidly connected to the first container 200, thereby fluidly connecting the first container 200, which includes a first fluid volume 202, to the second container 300, which includes a second fluid volume 302.

[0387] Then, the fluid in the first fluid volume 202 can be introduced into the second fluid volume 302. Alternatively, the fluid in the second fluid volume 302 can then be introduced into the first fluid volume 202.

[0388] In other examples where the second bias force F2 of the second spring 122 is greater than the first bias force F1 of the first spring 120, the diaphragms 108 and 110 are pierced sequentially in reverse order. That is, the first diaphragm 108 is pierced first, thereby fluidly connecting the first container 200 first, and then the second diaphragm 110 is pierced, thereby fluidly connecting the second container 300 second.

[0389] To remove the fluid connection between the two fluid volumes, the method is performed in reverse. That is, the outer sleeve 134 rotates in opposite directions, causing the hollow needle 112 to retract first from the first container 200 and the first diaphragm seal 114, and then from the second container 300 and the second diaphragm seal 116, as shown. Figure 11 As shown. Then, the connector 100 can be removed by pressing the support leg 310 to remove the protrusion 308 from the circumferential groove 138 of the outer sleeve 134.

[0390] like Figures 12 to 18 As shown, another embodiment of a connector 400 for connecting two fluid volumes is provided. Connector 400 is particularly suitable for rapid sampling of a given volume of fluid. Except for the details listed below, the construction of connector 400 is the same as that of connector 100. Similar reference numerals indicate similar features.

[0391] Connector 400 includes housing 102 and does not include outer sleeve 134 as described with respect to the first connector 100. However, in some examples, outer sleeve 134 may be present, or its components may be formed as part of the outer surface of housing 102.

[0392] The housing 102 additionally includes an axially movable cap 402 located at its distal end 104. The cap 402 serves to maintain a sterile environment within the housing 102. The cap 402 may include a puncture-resistant, rupture-resistant, or diaphragm seal (not shown) that allows the hollow needle 112 to puncture it while maintaining a sterile environment. The cap 402 is axially movable along the longitudinal axis of the connector 400; that is, the cap can retract or slide relative to the housing 102.

[0393] The connector 400 is used in a manner similar to that described with respect to connector 100. First, connector 400 is connected to a first container 500, which in this embodiment is depicted as a vacuum container having a first fluid volume 502. The first container 502 includes a threaded outer sleeve 504 and a diaphragm seal 506. The first container 502 is inserted into a cap 402, and the threaded outer sleeve 504 is threadedly engaged with the threaded portion 107 of the housing 102.

[0394] Once the first container 500 is connected to the connector 400 at its distal end 104, the connector 400 is connected to the second container 600 at its proximal end 106. In the depicted embodiment, the second container 600 is a cap that can be attached to or connected to a bioreactor (not shown), the second container having a second fluid volume 602 and a diaphragm seal 604. The connector 400 and the second container 600 can be connected in any suitable manner, including the manner described above with respect to the connector 100 and the second container 300.

[0395] like Figure 14 As shown, once the connector 400, the first container 500, and the second container 600 are connected, the first container 500 moves axially (i.e., is pushed) toward the second container 600. In this way, as described above, the hollow needle 112 first pierces the second diaphragm seal 110 of the housing 102 and the diaphragm seal 604 of the second container 600, as... Figure 15 As shown. Therefore, the second end 116 of the hollow needle 102 is fluidly connected to the second fluid volume 602.

[0396] like Figure 16 As shown, as the first container 500 is continuously pushed toward the second container 600, the hollow needle 112 pierces the diaphragm seal of the cap 402 and the diaphragm seal 506 of the first container 500. In doing so, the first end 114 of the hollow needle 102 is fluidly connected to the first fluid volume 502, thereby fluidly connecting the first fluid volume 502 to the second fluid volume 602.

[0397] Once the operation is complete, such as Figure 17 and 18 As shown, the user stops applying pressure to the first container 500, that is, stops pushing the first container 500, so that the connector 400 can be removed from the second container 600.

[0398] Additionally or alternatively, in some examples, connector 400 may be detached from the connection mechanism on the second container 600. The first container 500 can then be removed from connector 400 by unscrewing the threaded sleeve 504 of the first container from connector 400.

[0399] although Figures 12 to 18 The embodiments utilize two springs as part of the actuation mechanism, but it will be apparent to those skilled in the art that such an actuation mechanism can be replaced by any other actuation mechanism discussed herein (particularly the actuation mechanism discussed in the embodiments described below).

[0400] like Figures 19 to 27 As shown, another embodiment of a connector 700 for connecting two fluid volumes is provided. Except for the details listed below, the construction of connector 700 is similar to that described above. Figures 1 to 11 The connector 100 described herein has the same construction. Similar reference numerals indicate similar features.

[0401] Connector 700 includes, for example Figure 21 (a) to 21(e) as best shown, the lower housing portion 102b and as shown Figure 22 The upper housing portions 102a, best shown in (a) to 22(e), are composed of, as Figure 23The outer sleeve 134 is best shown in (a) to 23(e).

[0402] like Figure 19 As shown, the outer sleeve 134 of the connector 700 includes a plurality of teeth 702 formed as recesses within the outer surface of the outer sleeve 134. The plurality of teeth 702 are configured and arranged to engage with mating features of an automated actuation mechanism formed as part of an instrument (not shown). In this way, the outer sleeve 134 can be automatically actuated (i.e., rotated) by an actuation mechanism of an instrument, incubator, etc.

[0403] refer to Figure 21 (a) to 21(e) and further refer to Figure 22 (a) to 22(e), the lower housing portion 102b includes an inner body concentrically displaced within and attached to the outer body. The inner and outer bodies generally have the same height. Furthermore, the lower housing portion 102b includes a plurality of arms 704, each arm 704 extending axially from an upper or distal portion of the lower housing portion 102b. Each arm 704 also has a hook 706 at its distal end. The arms 704 may be elastically deformable or flexible. The lower housing portion 102b also includes a plurality of outwardly inclined tongues 708, which are inclined outward relative to a central longitudinal axis and optionally formed within a cutout portion of the outer body of the lower housing portion 102b. The tongues 708 may be elastically deformable or flexible. The tongues 708 are arranged to engage at their distal ends with the bottom edge of the upper housing portion 102a to prevent the upper housing portion 102a from being positioned above the lower housing portion 102b. In this way, the tongue 708 is formed as a pin-safe feature so as to allow the upper housing portion 102a to be positioned above the lower housing portion 102b only when needed and intended. This mitigates unintended axial translation of the upper housing portion 102a relative to the lower housing portion 102b. Specifically, in use, the upper housing portion 102a is positioned above the lower housing portion 102b. The bottom edge of the upper housing portion 102a engages with the tongue 708. The tongue 708 must be pushed inward by an actuating mechanism or the user to allow the upper housing portion 102a to be positioned above the lower housing portion 102b. In some examples, the tongue 708 may be pushed inward by one or more pins of an actuating mechanism (not shown). Conversely, when the upper housing portion 102a is removed from the lower housing portion 102b, the upper housing portion 102a is axially removed, and the tongue 708 returns to its original position by virtue of its elastically deformable nature.

[0404] The 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 the circumferential skirt 710. Each resiliently deformable portion 714 includes an outwardly extending or radially extending boss 716, which is configured and arranged to engage in use with a circumferential groove 138 of the outer sleeve 134 of the connector 700 (see...). Figure 20 This creates a snap-fit ​​arrangement. The circumferential skirt 710 may be interrupted by an opening that is constructed and arranged to receive a sterilization sealing system, as further described below.

[0405] refer to Figure 22 (a) to 22(e), the upper housing portion 102a includes a plurality of windows 720, which are configured and arranged to receive, in use, an arm 704 and its hook 706 passing through it (see...). Figure 21 (a) to 21(e)). Hook 706 (see Figure 21 (a) through (e)) are constructed and arranged to hold the lower housing portion 102b on the upper housing portion 102a and prevent its accidental release. Therefore, pin puncture 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. Thus, quick and pin-safe assembly and disassembly of the connector can be achieved.

[0406] In addition, the upper housing portion 102a also includes a plurality of protrusions formed as circular cylinders 722, which extend radially outward from the main body of the upper housing portion 102a, and these protrusions are aligned with... Figures 1 to 11 The same manner described in the above embodiments is configured and arranged to mate with the track 136 of the outer sleeve 134. A slot 724 is also provided formed in the body of the upper housing portion 102a, extending axially downward from each post 722 toward the bottom edge of the upper housing portion 102a. The slot 724 is configured and arranged to allow one or more pins or similar features of an actuating mechanism (not shown) to protrude therefrom to engage the pin safety feature (i.e., as described above). Figure 21 (a) to 21(e) the tongue 708) and / or protruding therefrom after actuation. Therefore, during assembly, the slot 724 and Figure 21 The tongues 708 of (a) to 21(e) are aligned and leave protruding space for one or more pins of the actuation mechanism (not shown).

[0407] refer to Figure 19 , 20In 24(a) to 24(e), connector 700 is provided with a sterile sealing system 730, which is constructed and arranged to mate with a corresponding sterile sealing system (not shown) on another component (such as a receiver, interface, etc.). The sterile sealing system 730 is provided with a clamping portion 732 and a sterile membrane 734. The clamping portion is preferably made of high-density polyethylene (HDPE) and is constructed and arranged to clamp onto the outer sleeve 134 of connector 700 during use. The clamping portion 732 is provided with a pair of substantially parallel lateral rails 735, each having an upright wall 736 at one end and an orifice 738 at the other end.

[0408] The vertical wall 736 is provided with radially outwardly extending protrusions 740. See details. Figure 19 and Figure 20 The track 735 is constructed and arranged to be slidably received within a corresponding portion of the outer sleeve 134 and detachably coupled to the circumferential groove 138 of the outer sleeve via the protrusion 740. As described above, the sterilization sealing system 730 is also arranged to be received within the space of the lower housing portion 102b. Thus, once received within the lower housing portion 102b in use, the protrusion 740 and the upright wall 736 cause the circumferential skirt 710 of the lower housing portion 102b (see Figure 21 (a) through 21(e)) become intact. In use, the upright wall 736 may break when the sterilized sealing system 730 is removed from the connector 700; that is, the upright wall 736 may be fragile. Therefore, this contributes to the single-use nature of the sterilized sealing system 730. Alternatively, the upright wall 736 may be separated from the outer sleeve 134 before removal.

[0409] The orifice 738 is configured and arranged to receive a corresponding protrusion formed as part of an actuation system (not shown) for engagement with it. Upon actuation, the protrusion engages the orifice 738 to allow slidable removal of the clamping portion 732 and the associated sterilization membrane 734.

[0410] The sterilization membrane 734 can be formed as a sterilization paper seal, a polyethylene film, etc., and is typically attached to the clamping portion 732. The sterilization membrane 734 includes at least one fold 742. The at least one fold 742 forms a sterilization surface 744 and a mating surface 746. The sterilization surface 744 is arranged to sterilize in use and seal (i.e., cover) the second diaphragm seal 110 (see...). Figure 2 The mating surface 746 is arranged to mate and match with a corresponding mating surface (not shown) of a corresponding sterilized sealing system (not shown). The mating surface 746 can mate with the corresponding mating surface by means of thermal welding, bonding, etc.

[0411] refer to Figure 25(a) to 25(e) show the collar 118 of the connector 700 in more detail. The collar 118 is formed to engage with the hollow pin 112 via friction fit. Figure 20 and 25 As can be seen in (d), the collar 118 is positioned off-center toward the second end 116 of the hollow needle 112 or away from the first end 114 of the hollow needle 112.

[0412] refer to Figure 20 and 26 (a) through 26(e), connector 700 further includes a flexible protective cover 760, typically formed as a cylindrical sleeve. The flexible protective cover 760 is coupled to the upper housing portion 102a at its distal end 762 and to the lower housing portion 102b at its proximal end 764. The protective cover 760 is flexible to accommodate axial displacement between the upper housing portion 102a and the lower housing portion 102b during use. The protective cover 760 can be coupled at its distal end 762 and proximal end 764 by any suitable means, such as by welding, adhesive, clips, etc.

[0413] refer to Figures 19 to 26 Especially reference Figure 27 (a) to 27(e) show connector 700 in use. Figure 27 In (a), connector 700 is coupled to corresponding fluid volumes (not shown) at its distal end 104 and proximal end 106. The sterile membrane 734 of sterile sealing system 730 is coupled to a corresponding sterile membrane on a fluid volume (not shown) adjacent to proximal end 106. An actuating device then preferably removes the sterile sealing system 730 coupled to the corresponding sterile sealing system (not shown) by slidably removing (i.e., pulling) the clamping portion 732 of the sterile sealing system 730. In some examples, the actuating device may include a protrusion received within an orifice 738 of the clamping portion 732. The action of slidably removing the sterile diaphragm 734 allows the second diaphragm seal 110 of connector 700 to sterilely engage face-to-face with a corresponding diaphragm seal of a given fluid volume. In some examples (such as the example shown), the sterile sealing system 730 remains in place, and a hollow needle 112 is arranged to pierce the sterile membrane 734.

[0414] like Figure 27 As shown in (b), the connector 700 is preferably actuated by a toothed actuation mechanism that engages with a plurality of teeth 702 on the outer sleeve 134 of the connector 700, thereby rotating the outer sleeve 134. Figure 27 As shown in (b) and 27(c), the continuous rotation of the outer sleeve 134 provides sequential puncture of the first diaphragm seal 108 and the second diaphragm seal 110, as described above, to provide a sterile fluid path between the two fluid volumes. Then, as... Figure 27As shown in (d) and 27(e), the actuation mechanism rotates the outer sleeve 134 in the opposite direction via the gear 702, thereby disconnecting the connection of the hollow needle 112 to a certain fluid volume under sterile conditions by sequentially disconnecting the connection of the hollow needle 112 to the first diaphragm seal 108 and the second diaphragm seal 110 under sterile conditions. The connector 700 can then be removed and discarded.

[0415] like Figures 28 to 30 As shown, another embodiment of a connector 800 for connecting two fluid volumes is provided. Except for the details listed below, the construction of connector 800 is similar to that described above. Figures 1 to 11 The connector 100 described herein has the same construction. Similar reference numerals indicate similar features.

[0416] like Figure 29 As shown, connector 800 includes a single helical spring 802 received between collar 118 and upper housing portion 102a. Specifically, the single helical spring 802 extends from the inner surface 126 of the distal end 104 of housing 102 (i.e., the inner surface 126 of upper housing portion 102a) to the upper surface 124 of collar 118. In other embodiments, the single helical spring may be received between collar 118 and lower housing portion 102b. In those embodiments, the single helical spring 802 extends from the inner surface 130 of the proximal end 106 of housing (i.e., the inner surface 130 of lower housing portion 102b) to the lower surface 128 of collar 118. In those embodiments, sequential piercing will be performed in the reverse order of the following sequence.

[0417] Further reference Figure 28 and 29 The upper housing portion 102a of connector 800 includes a pair of actuating lugs 804a, 804b. The actuating lugs 804a, 804b are shown as generally cylindrical protrusions extending radially from the outer surface of the upper housing portion 102a. The actuating lugs 804a, 804b can be of any size or shape. The outer sleeve 134 of connector 800 includes a pair of longitudinal slots 806, each slot being configured and arranged to receive one of the actuating lugs 804a, 804b. The actuating lugs 804a, 804b are axially movable, and the actuating lugs are also guided by the longitudinal slots 806 to allow axial translation (i.e., retraction) of the upper housing portion 102a relative to the lower housing portion 102b, as further described below. In other examples, the actuating lugs may be formed on the lower housing portion 102b to achieve sequential piercing via a sequence reversed from the order described below.

[0418] Connector 800 further includes the above-mentioned Figure 19 , 20 The sterilization sealing system 730 described in 24(a) to 24(e).

[0419] Further Special Reference Figure 30 (a) to 30(e) show connector 800 in use. Figure 30 In (a), connector 800 is coupled to corresponding fluid volumes at its distal end 104 and proximal end 106. The sterile membrane 734 of sterile sealing system 730 is coupled to a corresponding sterile membrane on a fluid volume (not shown) adjacent to proximal end 106. An actuating device then preferably removes the sterile sealing system 730 coupled to the corresponding sterile sealing system (not shown) by slidably removing (i.e., pulling) the clamping portion 732 of the sterile sealing system 730. In some examples, the actuating device may include a protrusion received within an orifice 738 of the clamping portion 732. The action of slidably removing the sterile diaphragm 734 allows the second diaphragm seal 110 of connector 800 to sterilely engage face-to-face with the corresponding diaphragm seal of the receiver. In some examples (such as the example shown), the sterile sealing system 730 remains in place, and a hollow needle 112 is arranged to pierce the sterile membrane 734.

[0420] like Figure 30 As shown in (b), the connector 800 is preferably actuated by an axially translatable actuation mechanism that engages with the distal end 104 of the connector 800, thereby causing the upper housing portion 102a to be axially translated (i.e., pushed or retracted) relative to the lower housing portion 102b. Alternatively, the actuation mechanism may be coupled to the pair of actuable lugs 804a, 804b (see... Figure 28 The upper housing portion 102a is engaged to allow axial translation of the upper housing portion. The actuation mechanism can be incorporated into the instrument (e.g., an incubator). Figure 30 As can be seen in (b), when the upper housing portion 102a contracts relative to the lower housing portion 102b, the collar 118 and the hollow needle 112 operably coupled thereto translate axially toward the second diaphragm seal 110 at its proximal end 106 of the connector 800. Due to the biasing force applied to the collar 118, the spring 802 remains in its initial configuration during this initial actuation step. Therefore, this axial translation causes the hollow needle 112 to pierce the second diaphragm seal 110 at its second end 116.

[0421] like Figure 30 As shown in (c), the continuous axial translation of the upper housing portion 102a causes compression of the spring 802, thereby allowing the upper housing portion 102a to contract further and thus causing the hollow needle 112 to pierce the first diaphragm seal 108 at its first end 114. Therefore, the fluid volume connected at each end of the connector 800 is fluidly connected via the hollow needle 112.

[0422] like Figure 30As shown in (d), the biasing force of spring 802 allows the upper housing portion 102a to relax, or to translate axially toward the distal end 104 of connector 800 (i.e., away from the proximal end 106 of connector 800). In this way, the hollow needle 112 stops piercing the first diaphragm seal 108 at its first end 114. Figure 30 As shown in (e), further axial translation of the upper housing portion 102a toward the distal end 104 of the connector 800 causes the hollow needle 112 to stop piercing the second diaphragm seal 110 at its second end 116. Thus, sterile disconnection is achieved. The connector 800 can then be removed and discarded.

[0423] like Figures 31 to 35 As shown, another embodiment of a connector 900 for connecting two fluid volumes is provided. Except for the details listed below, the construction of connector 900 is similar to that described above. Figures 1 to 11 The connector 100 described herein has the same construction. Similar reference numerals indicate similar features.

[0424] like Figures 31 to 33 As shown, unlike the previous embodiments, the connector 900 in this embodiment does not include a spring. Instead, the connector 900 is provided with a collar 118 including a plurality of actuable lugs 902 extending radially outward from the collar 118. The actuable lugs 902 can be of any size or shape. Furthermore, the upper housing portion 102a includes a plurality of actuable lugs 904 extending radially outward from the upper housing portion 102a. Again, the actuable lugs can be of any size and shape.

[0425] The outer sleeve 134 of connector 900 includes two semi-tube portions 134a and 134b, which can be welded, glued, clamped, etc., to secure them during use. Alternatively, the outer sleeve 134 can be formed integrally. The outer sleeve 134 typically includes a first set of multiple longitudinal slots 906 and a second set of multiple longitudinal slots 908. For example... Figure 31 As shown, each of the plurality of actuating lugs 902 of the collar 118 extends radially outward through each of the first set of a plurality of longitudinal slots 906, and each of the plurality of actuating lugs 904 of the upper housing portion 102a extends radially outward through each of the second set of a plurality of longitudinal slots 908. Further reference Figure 31 The lower stops of the first group of longitudinal slots 906 and the lower stops of the second group of longitudinal slots 908 are coplanar, meaning they are formed at substantially similar or identical distances relative to the proximal end 106 of the connector 900. The upper stops of the first group of longitudinal slots 906 and the upper stops of the second group of longitudinal slots 908 are not coplanar, meaning they are formed at substantially different distances relative to the proximal end 106 of the connector 900.

[0426] like Figure 34 As shown, the plurality of actuated lugs 902 extending from the collar 118 are each offset by approximately 120°. Similarly, the plurality of actuated lugs 904 extending from the upper housing portion 102a are each offset by approximately 120°. The slots of the first group of multiple longitudinal slots 906 and the slots of the second group of multiple longitudinal slots 908 are similarly offset by 120° relative to the other slots within the plurality of slots. Typically, as Figure 34 As shown, the actuating lug 902 of the collar 118 and the actuating lug 904 of the upper housing portion 102a are offset relative to each other. Similarly, the first set of multiple longitudinal slots 906 and the second set of multiple longitudinal slots 908 are offset relative to each other.

[0427] refer to Figures 31 to 34 Connector 900 is further provided with the features mentioned above. Figure 19 , 20 The sterilization sealing system 730 described in 24(a) to 24(e). However, as Figure 33 As best shown, the sterilization sealing system 730 does not include a protrusion for clamping onto the outer sleeve of the connector 900. Therefore, the sterilization sealing system 730 can slide freely relative to the outer sleeve.

[0428] Figure 35 (a) through 35(e) show connector 900 in use. Figure 35 In (a), connector 900 is coupled to corresponding fluid volumes at its distal end 104 and proximal end 106. The sterile membrane 734 of the sterile sealing system 730 is coupled to a corresponding sterile membrane on a fluid volume adjacent to proximal end 106. The actuating device then preferably removes the sterile sealing system 730 coupled to the corresponding sterile sealing system (not shown) by slidably removing (i.e., pulling) the clamping portion 732 of the sterile sealing system 730. In some examples, the actuating device may include a protrusion received within an orifice 738 of the clamping portion 732. The action of slidably removing the sterile diaphragm 734 allows the second diaphragm seal 110 of connector 900 to sterilely engage face-to-face with a corresponding diaphragm seal of a given fluid volume. In some examples (such as the example shown), the sterile sealing system 730 remains in place, and a hollow needle 112 is arranged to pierce the sterile membrane 734.

[0429] like Figure 35As shown in (b), the connector 900 is preferably actuated by an axially translatable actuation mechanism that engages with an actuable lug 904 extending from the upper housing portion 102a of the connector 900, thereby causing the upper housing portion 102a to be axially translated (i.e., pushed or retracted) relative to the lower housing portion 102b. Simultaneously, the axially translatable actuation mechanism engages with an actuable lug 902 extending from the collar 118 of the connector 900, so that the collar 118 and the hollow needle 112 are axially translated (i.e. pushed) toward the second diaphragm seal 110. Thus, the second end 116 of the hollow needle 112 pierces the second diaphragm seal 110. The actuation mechanism can be formed as part of an instrument (e.g., an incubator).

[0430] like Figure 35 As shown in (c), the axially translatable actuation mechanism, engaging with the actuating lug 904 extending from the upper housing portion 102a, continues to axially translate the upper housing portion 102a toward the proximal end 106 of the connector 900. Simultaneously, the axially translatable actuation mechanism, engaging with the actuating lug 902 of the collar 118, holds the collar 118 in place during further actuation of the upper housing portion 102a. In this way, the first end 114 of the hollow needle 112 pierces the first diaphragm seal 108, as... Figure 35 As shown in (c). In this way, a sterilization fluid path is formed between the connected fluid volumes.

[0431] like Figure 35 As shown in (d), in order to disconnect the connector 900 under sterile conditions, the upper housing portion 102a is axially translated toward the distal end 104 of the connector 900 by means of an axially translatable actuation mechanism that engages with the actuable lug 904 of the upper housing portion 102a. In this way, the hollow needle 112 stops piercing the first diaphragm seal 108 at its first end 114.

[0432] like Figure 35 As shown in (e), a further axial translation of the upper housing portion 102a of the connector 900 is provided by an actuation mechanism engaging with the actuating lug 904 of the upper housing portion 102a. Simultaneously, via an actuation mechanism engaging with the actuating lug 902 of the collar 118, the collar 118 and the hollow needle 112 are axially translated toward the distal end 104 of the connector 900, thereby stopping the hollow needle 112 from piercing the second diaphragm seal 110 at its second end 116. Thus, the connector 900 is fluidly disconnected under sterile conditions. The connector 900 can then be removed and discarded.

[0433] like Figures 36 to 50 As shown, another embodiment of a connector 1000 for connecting two fluid volumes is provided. Except for the details listed below, the construction of the connector 1000 is similar to that described above. Figures 31 to 35The connector 900 described herein has the same construction. Similar reference numerals indicate similar features.

[0434] like Figures 36 to 38 As shown, connector 1000 is structurally similar to connector 900, except that the actuating lug 902 of collar 118, operably coupled to hollow needle 112, and the actuating lug 904 of upper housing portion 102a are aligned and thus each can move axially within the same longitudinal slot 1002 of outer sleeve 134 of connector 1000. Furthermore, collar 118 has three actuating lugs 902: the first actuating lug is offset by 90° from the second actuating lug, the second actuating lug is offset by 90° from the third actuating lug, and the third actuating lug is offset by 180° from the first actuating lug. The same applies to the actuating lug 904 of upper housing portion 102a and longitudinal slot 1002. Therefore, the actuating lugs 902 and 904 are typically arranged in a T-shape.

[0435] Figure 40 (a) through 40(e) show the lower housing portion 102b of connector 1000 in more detail. Specifically, as described elsewhere, the lower housing portion 102b includes an outer, generally cylindrical body 1004 and an inner, generally cylindrical body 1006. The outer body 1004 and the inner body 1006 are substantially concentric and are separated by an annular space 1008. As described below, the upper housing portion 102a is arranged to be axially translatable above the outer body 1004. The inner body 1006 is used to receive a collar 118 and a hollow pin 112. The outer body 1004 is provided with a plurality of slots 1010 configured to allow actuation lugs 902 of the collar 118 (see...) Figure 36 ) and the actuable lug 904 of the upper housing portion 102a (see Figure 36 The internal body 1006 is provided with a plurality of slots 1012, which are configured to allow the actuating lug 902 of the collar 118 (see...) to protrude during use. Figure 36 It should be highlighted during use.

[0436] Figure 41 (a) through 41(e) show the upper housing portion 102a of the connector 1000 in more detail. Specifically, as described above, the upper housing portion 102a includes a plurality of actuating lugs 904 extending radially outward from the body of the upper housing portion 102a. Furthermore, the upper housing portion 102a is provided with a plurality of slots 1014 configured to allow the actuating lugs 902 of the collar 118 (see...) Figure 36 It protrudes from it during use. The upper housing portion 102a further includes a circumferentially projecting flange that separates the threaded portion 107 from the rest of the upper body portion 102a.

[0437] Figure 42 (a) through 42(e) show the collar 118 of the connector 1000 in more detail. As described above, the collar 118 is provided with a plurality of actuating lugs 902 projecting radially outward from the collar 118. As described above with respect to other embodiments, the collar 118 includes a generally cylindrical outer body 1016 and a generally cylindrical inner body 1018, with the actuating lugs 902 projecting from the outer body, and the inner body being constructed and arranged to operably engage the hollow needle 112, for example by friction engagement. An annular recess 1020 is provided between the inner body 1016 and the outer body 1018, which, in embodiments utilizing a spring, is configured to receive a spring. Figure 42 As can be seen in (a) to 42(e), the collar 118 is positioned off-center from the center of the hollow needle 112, such that the position of the collar 118 is closer to (i.e. closer to or toward) the second end 116 of the hollow needle 112 or the position of the collar 118 is further away from (i.e. further away from or away from) the first end 114 of the hollow needle 112.

[0438] Further reference Figure 37 and 43 (a) to 43(e), a first protective shield 1022 and a second protective shield 1024 surround the hollow needle 112 under sterile conditions. The first protective shield 1022 surrounds the upper portion of the hollow needle 112, extending from the collar 118 to a first end 114 of the collar. The second protective shield 1024 surrounds the lower portion of the hollow needle 112, extending from the collar 118 to a second end 116 of the collar. Thus, the protective shields 1022 and 1024 ensure a sterile environment for the hollow needle 112 and also prevent accidental needlestick injuries. The protective shields 1022 and 1024 are typically in a multi-pleated or corrugated shape, meaning they have multiple Z-shaped folds, and the protective shields may be made of flexible or elastically deformable materials to allow the protective shields 1022 and 1024 to contract during use. In some examples, the protective covers 1022 and 1024 may be independently composed of low-density polyethylene (LDPE), thermoplastic elastomer, etc. The first protective cover 1022 is secured to the upper housing portion 102a at one end and to the collar 118 at the other end by any suitable means (e.g., protective cover clip 1026 preferably composed of high-density polyethylene (HDPE), adhesive, heat welding, etc.). Similarly, the second protective cover 1024 is secured to the lower housing portion 102b at one end and to the collar 118 at the other end by any suitable means (e.g., protective cover clip 1026 preferably composed of high-density polyethylene (HDPE), adhesive, heat welding, etc.).

[0439] Figure 44(a) through 44(e) show the outer sleeve 134 of connector 1000 in more detail. Figure 44 As shown in (a) and 44(b), the outer sleeve 134 includes two generally semi-tubular portions 134a, 134b, which are substantially mirror images of each other. Each semi-tubular portion 134a, 134b of the outer sleeve 134 includes a sidewall 1032 terminating at a base 1034. The sidewall 1032 includes a plurality of longitudinal slots 1030, at least a portion of which are configured and arranged to allow actuable lugs 902, 904 to protrude therefrom during use, the slots extending axially within the sidewall 1032. The base 1034 further includes a sterile sealing system receiving region 1036, which is configured and arranged to receive a sterile sealing system, such as those described above. Figure 19 , 20 As described in 24(a) to 24(e) and Figure 36 and 37 The sterilization sealing system 730 is shown. A receiving area 1036 is shaped in a complementary manner to the sterilization sealing system 730. The receiving area 1036 may include one or more mating features (e.g., guide rails) that mate with one or more features (e.g., tracks) of the sterilization sealing system. In use, the receiving area 1036 may expose part or all of a second diaphragm seal (not shown). The sidewall 1032 includes one or more longitudinal grooves 1038 that terminate in corresponding orifices 1040 in the base 1034. The longitudinal grooves 1038 and orifices 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. Furthermore, the longitudinal grooves 1038 and orifices 1040 may mate with a fixing feature formed as part of an instrument, housing, containment mechanism, or incubator to restrict connector movement.

[0440] Figure 45 (a) to 45(e) show the assembled upper housing portion 102a, lower housing portion 102b, hollow needle 112, collar 118, and protective covers 1022 and 1024. It can be seen that the actuating lug 902 of the collar 118 and the actuating lug 904 of the upper housing portion 102a protrude outward through the respective slots as described above.

[0441] Figure 46 (a) to 46(d) show Figure 45 (a) to 45(e) assembly components, further including those assembled thereon Figure 44(a) to 44(f) the outer sleeve 134. It can be seen that, prior to assembling the sterilized sealing system, the second diaphragm seal 110 is exposed within the receiving area 1036 in the base 1034 of the outer sleeve 134. In this particular embodiment, the diaphragm seal 110 is formed of a material co-molded with a lower body portion having an annular raised region that defines a flat puncture area therein.

[0442] Figure 47 (a) to 47(f) show a sterilized sealing system 730 similar to the sterilized sealing system described above, for connector 1000. Figure 47 (f) shows a sterilization sealing system 730 received within a receiving portion 1036 of an outer sleeve 134.

[0443] Figure 48 (a) through 48(c) show a transport cover 1050 and a transport cap 1060 for use with connector 1000. Transport cover 1050 includes a hollow body whose size and shape are adapted to complement connector 1000 so as to receive connector 1000 within the hollow body. Transport cap 1060 is sized and shaped to complement proximal end 106 of connector 1000, and its shape and size are particularly suited to the shape and size of sterilization sealing system 730.

[0444] Figure 49 Images (a) to 49(d), 50(a) and 50(b) illustrate a receiving mechanism 1100 for accommodating connector 1000 in use, which may optionally be incorporated into an instrument, housing, or incubator. Figure 49 As best shown in (a) through 49(d), the receiving mechanism 1100 includes a generally columnar sidewall 1102 terminating at a base 1104. The sidewall 1102 includes a plurality of slots 1106 configured and arranged to receive or otherwise allow protruding actuating lugs 902, 904 of the connector to project therefrom. The base 1104 is configured to allow the connector 1000 to be received within a cavity formed by the base 1104 and the sidewall 1102. The base 1104 includes a plurality of recesses 1108 or pins or the like that stand upright on the base and parallel to the sidewall 1102, configured and arranged to engage and project therefrom longitudinal grooves 1038 and orifices 1040 formed in the outer sleeve 134 of the connector 1000. In this way, the connector 1000 can be easily positioned in the correct location. Each notch 1108 includes an enlarged head, the size and shape of which complement the orifice 1040 of the outer sleeve 134, to prevent the connector 1000 from moving within the receiving mechanism 1100 during use. Furthermore, during use, the notch 1108 extends via a slot 724 (see...). Figure 22(a) to 22(e)) and tongue 708 (see Figure 21 (a) to 21(e)) engagement is performed to activate the tongue 708 and allow secure actuation of the needles in the upper housing portion 102a and the lower housing portion 102b. The base 1104 further includes a cutout region 1110 configured to receive a sterile sealing system 730 of the connector 1000.

[0445] Figure 50 (a) and (b) show a connector 1000 and a receiving mechanism 1100 used 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 sealing systems 1152, which are complementary to the sterile sealing system 730. Specifically, each sterile sealing system 1152 includes a protrusion 1154 configured and arranged to interact with a portion 732 of the sterile sealing system 730 (e.g., an orifice 738). Figure 47 (a) to 47(f))) are connected. Furthermore, each sterilized sealing system includes a sterilization membrane 1156, which is configured to connect with the sterilization membrane 734 of the sterilized sealing system 730 (see also...). Figure 47 (a) Connection. The connection of membranes 734 and 1156 can be achieved by means of adhesive, thermal welding, etc. Once connected, the actuating device (not shown) can remove the connected sterile sealing system 730 and 1152, thereby exposing the second diaphragm seal 110 to the diaphragm seal 1158 of the interface plate 1150.

[0446] like Figures 51 to 62 As shown, another embodiment of a connector 1200 for connecting two fluid volumes is provided. Except for the details listed below, the construction of connector 1200 is similar to that described above. Figures 36 to 50 The connector 1000 described herein has the same construction. Similar reference numerals indicate similar features.

[0447] Connector 1200 includes a pair of actuated lugs 902 projecting from collar 118, instead of the three actuated lugs shown in connector 1000. The pair of actuated lugs 902 extend in opposite directions relative to each other, spaced 180° apart. In other words, the actuated lugs 902 extend radially outward and are diametrically opposed to each other. Similarly, connector 1200 includes a pair of actuated lugs 904 projecting from upper housing portion 102a, instead of the three actuated lugs shown in connector 1000. The pair of actuated lugs 904 extend in opposite directions relative to each other, spaced 180° apart. In other words, the actuated lugs 904 extend radially outward and are diametrically opposed to each other. Furthermore, both pairs of actuated lugs 902, 904 have a generally cross-shaped or cruciform cross-section. These features facilitate automation of the actuation mechanism.

[0448] Figure 51 The connector 1200 shown in (a) has a transport cover 1050 and a transport cap 1060, which are complementary to the corresponding ends of the connector 1200. It is noteworthy that the transport cover 1050 is used only to cover the proximal end of the connector 1200, while the transport cap 1060 is used only to cover the distal end of the connector 1200. Therefore, a portion of the connector 1200 remains uncovered. In some examples not shown, the transport cover 1050 and cap 1060 may be integrally formed to provide aseptic packaging for the connector 1200, which will be substantially as follows: Figure 51 (a) The package is contained within the transport cover 1050 and cap 1060 as shown in (a).

[0449] Figure 52 (a) and (b) show the outer sleeve 134 of the connector 1200. It can be seen that the outer sleeve 134 comprises only a pair of opposing longitudinal slots 1030 arranged in the sidewalls 1032 of the outer sleeve 134. As described above, such slots 1030 are arranged to allow actuating lugs 902, 904 to extend therefrom or otherwise protrude. As described above, the outer sleeve 134 may comprise two half-tube portions, or the outer sleeve may be formed as a single integral part. Feature 134c indicates a seam, weld, etc., between adjacent portions. The outer sleeve 134 may be composed of polycarbonate, acrylonitrile butadiene styrene (ABS), high-impact polystyrene sheet (HIPS), or other suitable materials.

[0450] Figure 53 (a) through 53(c) illustrate another embodiment of the sterile sealing system 1250 for connector 1200. The sterile sealing system 1250 includes a clamping portion 1252 and a sterile membrane 1254. Similar to... Figure 19 , 20The sterilization sealing system 730 shown in 24(a) to 24(e) has a clamping portion 1252 preferably composed of high-density polyethylene (HDPE), and this clamping portion is configured and arranged to clamp onto the outer sleeve 134 of the connector 1200 in use. In this particular example, the clamping portion 1252 includes a pair of substantially parallel lateral rails 1256 connected to a semi-circular wall 1258 and having shoulders 1259. The clamping portion 1252 also includes a protrusion 1260 projecting from the base 1262 of the clamping portion 1252, which is configured to engage and retain the sterilization diaphragm 1254. For this purpose, the protrusion 1260 may include one or more clamps. The lateral rails 1256 are arranged to correspond to the rail receiving portions of the outer sleeve 134 (see...). Figure 52 (a)) Fitting. The clamping part 1252 is also provided with a plurality of reinforcing ribs 1263 extending parallel to the track 1256.

[0451] The sterilization membrane 1254 can be formed as a sterilization paper seal, polyethylene film, etc., and is typically attached to the clamping portion 1252 by means of an orifice that engages with the protrusion 1260 and held in place by one or more clips. A fixing position 1265 is also provided for securing the sterilization membrane 1254 to the connector 1200 during use. The fixing position 1265 can mate with a corresponding feature of the connector 1200, or it can be used as a guide for correctly positioning the sterilization membrane 1254 during use for heat welding, bonding, etc.

[0452] Further reference Figure 54 (a) and 54(b), the clamping portion 1252 is slidably arranged within the track receiving portion of the outer sleeve 134. A semi-circular wall 1258 forms the outermost portion of the clamping portion 1252. A shoulder 1259 is arranged and configured to engage with the pushing portion of an actuation mechanism to slidably remove the clamping portion 1252, thereby removing the sterilization membrane 1254 from the diaphragm seal 110 in use.

[0453] Figure 55 (a) through 55(c) show the collar 118 of connector 1200. The collar 118 is substantially as described above and further includes a pair of apertures 1270 to allow air to pass between the upper and lower portions of the collar 118. In this way, smooth axial translation of the collar 118 is achieved in use. The collar 118 is preferably made of acrylonitrile butadiene styrene (ABS), high-impact polystyrene sheet (HIPS), polycarbonate, or similar materials. The hollow needle 112 is preferably made of stainless steel.

[0454] Figure 56 (a) through 56(c) show the first protective shield 1022 and the second protective shield 1024, which are substantially as described above. Figure 37 and 43 As described in (a) to 43(e), the protective cover may be composed of low-density polyethylene (LDPE), thermoplastic elastomer (TPE), silicone, or similar materials. As mentioned above, the protective cover clip may be composed of high-density polyethylene (HDPE).

[0455] Figure 57 (a) through 57(c) show the lower housing portion 102b of the connector 1200. The lower housing portion 102b further includes an inlet slot 1272 to allow the user to access the second protective shield 1024 during use (see Figure 60 (b) Furthermore, the second diaphragm seal 110 is provided with a raised annular region 1274, which, in use, surrounds the flat portion 1276 for puncture. A fixing point 1278 is also provided for securing a sterilizing membrane (not shown) to the lower housing portion 102b, specifically located above the diaphragm seal 110. The lower housing portion 102b may be composed of polycarbonate, acrylonitrile butadiene styrene (ABS), high-impact polystyrene sheet (HIPS), or similar materials. The diaphragm seal 110 may be composed of thermoplastic elastomer (TPE), silicone, etc.

[0456] Figure 58 (a) through 58(d) show the upper housing portion 102a of the connector 1200. The upper housing portion 102a further includes an inlet slot 1280 to allow the user to access the first protective cover 1022 during use (see...). Figure 60 (b) Furthermore, the protruding circumferential flange of the upper housing portion 102a in the previous embodiment is replaced by a step 1282. The upper housing portion 102a may be composed of polycarbonate, acrylonitrile butadiene styrene (ABS), high-impact polystyrene sheet (HIPS), or similar materials. The diaphragm seal 108 may be composed of thermoplastic elastomer (TPE), silicone, etc.

[0457] Figures 59 to 62 The assembly of connector 1200 is shown. First, the protective covers 1022, 1024 are clamped and attached to the collar 118, for example via clip 1026 or otherwise. Figure 59 Next, the collar 118 and the connected protective covers 1022 and 1024 are assembled into the lower housing portion 102b. Figure 60 (a) and 60(b)). The actuable lug 902 is also shown protruding outward through the lower housing portion 102b. Third, the upper housing portion 102a is arranged above the lower housing portion 102b. Figure 61(a) and 61(b)). Actuable lugs 902 and 904 are shown as protruding outwards, and are configured to be received within corresponding slots in the outer sleeve. Fourth, the outer sleeve 134 is arranged above the upper housing portion 102a and the lower housing portion 102b, and is secured, for example, by welding or clamping ( Figure 62 (a) and 62(b)) secure the outer sleeve in place to provide the assembled connector 1200.

[0458] like Figures 63 to 75 As shown, another embodiment of a connector 1300 for connecting two fluid volumes is provided. Except for the details listed below, the construction of connector 1300 is similar to that described above. Figures 51 to 62 The connector 1000 described herein has the same construction. Similar reference numerals indicate similar features.

[0459] Figure 64 (a) through 64(c) show a first portion 134a of the outer sleeve 134, which is formed as the front portion of the outer sleeve. The first portion 134a includes a sterilization sealing system inlet slot 1302a in a sidewall 1032 of the first portion 134a. A recess for a mark 1304 is also provided on the outer surface of the sidewall 1032. A shelf 1306a extending laterally from the inner surface of the sidewall 1032a is also provided, which is arranged to receive and retain internal components of the connector 1300, as further described below. The shelf 1306a also includes a track receiving portion for receiving the sterilization sealing system. Furthermore, the shelf 1306a includes one or more orifices 1307, two orifices in this embodiment, which are configured and arranged to allow one or more pins of an actuating mechanism (not shown) to protrude therefrom to activate a tongue 708 (see...). Figure 69 (a), as described below), thus relating to... Figure 21 The pin safety activation of the upper housing portion 102a and the lower housing portion 102b is provided in a manner similar to that described in (a) to 21(e), 22(a) to 22(e), and 44(a) to 44(f). The top wall 1308a of the first portion 134a includes an aperture 1310a to allow the upper housing portion 102a (see below) to protrude therefrom. The first portion 134a also includes a recess 1311 abutting the side wall 1032a to the top wall 1308a to allow the two portions to be welded together in use. The side wall 1032a further includes an arcuate slot 1309 for receiving a portion of the second portion 134b, as described below.

[0460] Figure 65(a) to 65(c) show a second portion 134b of the outer sleeve 134, which forms the rear portion of the outer sleeve. A shelf 1306b extending laterally from the inner surface of the sidewall 1032b is also provided, arranged to receive and retain internal components of the connector 1300, as further described below. The shelf 1306b includes one or more apertures 1309, two apertures in this embodiment, which are configured and arranged to allow one or more pins of an actuating mechanism (not shown) to protrude therefrom to activate the tongue 708 (see...). Figure 69 (a), as described below), thus relating to the above regarding Figure 64 The orifice 1307 of (a) and 64(b) provides needle safety activation for the upper housing portion 102a and the lower housing portion 102b in the same manner as described above.

[0461] The second portion 134b includes a pair of longitudinal slots 1312 formed in its sidewall 1032b to allow the actuation system to actuate the upper housing portion 102a and / or the collar 118 in use. The longitudinal slots 1312 are formed to prevent or at least mitigate interference between the user and the actuable lugs. The second portion 134b also includes an aperture 1310b formed in the top wall 1308b to allow the upper housing portion 102a (see below) to protrude therefrom, and the second portion also includes a flat rear wall 1314 having slots 1302b. The second portion 134b also includes raised ribs 1315 abutting the sidewall 1032b to the top wall 1308b to allow the two portions to be welded together in use, the raised ribs being received within recesses 1311 (see below). Finally, the sidewall 1302b includes a protective wall 1313 that forms a gripping area for the user and is arranged to be received within the arcuate slot 1309 (see above). The protective wall 1313 covers the longitudinal slot 1312 to close it off and helps prevent the user from entering the longitudinal slot 1312.

[0462] Note that the first part 134a and the second part 134b can be formed separately or integrally. If parts 134a and 134b are formed separately, any suitable method for joining parts 134a and 134b together is contemplated, including welding, bonding, clamping, etc.

[0463] Figure 66Images (a) to 66(c), 67(a), and 67(b) show the upper housing portion 102a of connector 1300. The upper housing portion 102a is provided with an anti-rotation feature 1320, which in this example is formed as a plurality of angled notches adjacent to or as part of the threaded portion 107 of connector 1300. The anti-rotation feature 1320 can mate with a corresponding anti-rotation feature (such as a complementary notch or slit) on the receiving part to be connected. Figure 67 As best shown in (a), the diaphragm seal 108 is co-molded with the upper housing portion 102a, and the diaphragm seal is formed of a raised annular portion that, in use, surrounds the flat portion for puncture.

[0464] Figure 68 Figures (a) and (b) show another embodiment of the upper housing portion 102a of the connector 1300. The upper housing portion 102(a) is as follows: Figure 66 As described in (a) to 66(c), 67(a) and 67(b), the upper housing portion further includes a pair of elongated ribs 1321 extending longitudinally on both sides of the actuating lugs 804a, 804b. The elongated ribs 1321 generally span a large portion of the length of the upper housing portion 102a. In use, the elongated ribs 1321 are frictionally engaged with a recess (not shown) or the inner surface of the outer sleeve 134.

[0465] Figure 69 (a) to 69(c), 70(a) and 70(b) show the lower housing portion 102b of the connector 1300. It can be seen that the lower housing portion 102b includes an inner body 1006 extending beyond the bottom edge of the outer body 1004. In this way, better engagement with the component to be coupled can be achieved. Furthermore, the lower housing portion 102b includes a co-molded diaphragm seal 110, substantially as described above.

[0466] The lower housing portion 102b further includes a plurality of reinforcing ribs 1301, each reinforcing rib being connected to one of the tongues 708. Each rib 1301 extends longitudinally or axially and is parallel to the tongue 708 to impart rigidity or increased strength. As described above regarding Figure 21 As described in (a) to 21(e) and 22(a) to 22(e), the tongue 708 serves as a needle safety feature.

[0467] Figure 71 (a) and (b) show another embodiment of the lower housing portion 102b of the connector 1300. It can be seen that the lower housing portion 102b is as follows: Figure 69As shown in (a) to 69(c), 70(a) and 70(b), the lower housing portion further includes a pair of flanges 1007 extending outward from the outer surface of the outer body 1004. The pair of flanges 1007 are diametrically opposed to each other, i.e., the pair of flanges are offset by an angle of 180 degrees. In use, as... Figure 71 As shown in (b), the pair of flanges 1007 are received in the corresponding slots 1009 of the outer sleeve 134 in order to prevent movement of the lower housing portion 102b during use.

[0468] Figure 72 (a) through 72(c) show a hollow pin 112 and a collar 118 of connector 1300. The hollow pin 112 is as described above, and specifically includes a nib-closed end 1011 (i.e., the closed end of the tip), which includes a port or aperture 1013 adjacent to the nib-closed end 1011 and extending perpendicularly to the axis of the hollow pin 112. The hollow pin further includes an open end 1015, which is beveled in the depicted embodiment.

[0469] Figure 73 (a) and (b) show another embodiment of the hollow pin 112 and collar 118 of connector 1300. It can be seen that the hollow pin 112, as... Figure 72 As described in (a) through 72(c), however, port 1013 extends through hollow needle 112, thereby forming a pair of openings 1013a, 1013b with opposing diameters. This allows fluid to drain from each opening to alleviate clogging of hollow needle 112 during use. The hollow needle further includes a longitudinally extending slot 1017 extending from the opening end 1015 toward collar 118. This allows fluid to be more easily drained from the connected container into the orifice of hollow needle 112.

[0470] Figure 74 Images (a) and (b) show a first protective shield 1022 and a second protective shield 1024. The first protective shield 1022 includes a central portion 1022a flanked by two end portions 1022b and 1022c. The central portion 1022a has a length greater than the lengths of the two end portions 1022b and 1022c. This arrangement facilitates proper contraction of the first protective shield 1022 during use. Specifically, the central portion 1022a of the bellows forms an extended cylindrical region without Z-shaped folds. This extended cylindrical region adjoins the two end portions 1022b and 1022c. The volume of the central portion 1022a can generally be larger than the volume of the end portions 1022b and 1022c.

[0471] Figure 75Images (a) to 75(c), 76(a), and 76(b) show a portion of a sterilization sealing system 1350, including a clamping portion 1352. The clamping portion 1352 is configured to be generally drawer-shaped. The clamping portion 1352 includes a front wall 1354, a rear wall 1356, and two side walls 1358 adjacent to the front wall 1354 and the rear wall 1356. Each side wall 1358 has a shoulder 1360. A base wall 1362 is configured to have a circular protrusion 1364 extending from the base wall. 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, extending parallel to the side walls 1358 and perpendicular to the front wall 1354 and the rear wall 1356. In some examples, a top wall (not shown) may also be provided.

[0472] A clamping portion 1352 is arranged to be coupled to a sterilization membrane (not shown) by means of a protrusion 1364. For this purpose, the protrusion 1364 may include one or more retaining clips. Furthermore, a shoulder 1360 is arranged to be engaged by an actuating mechanism so that the clamping portion 1352 can be pushed from the outer sleeve 134 once it is slidably received within the outer sleeve 134. Therefore, an automated system can be more easily implemented. The clamping portion 1352 may be composed of high-density polyethylene (HDPE), low-density polyethylene (LDPE), or similar materials.

[0473] Figure 77 (a) and (b) show another embodiment of the clamping portion 1352 of the connector 1300. It can be seen that the clamping portion 1352 is as follows: Figure 75 As shown in (a) to 75(c), 76(a) and 76(b), the clamping portion further includes positioning elements formed as longitudinally extending ribs 1365 formed on each sidewall 1358 of the clamping portion 1352. The ribs 1365 engage with corresponding ribs 1367 or corresponding recesses formed as part of the bottom portion of the outer sleeve 134.

[0474] Figure 78 Images (a) through 78(c) show a transport cover 1370 for covering the bottom (i.e., proximal end) of the connector 1300 during transport and storage. The transport cover 1370 is complementary in shape and size to the proximal end 106 of the connector 1300. Specifically, the transport cover 1370 includes a pair of protrusions 1372 configured to spatially engage corresponding portions of the connector 1300 and, in use, engage portions of the connector 1300 by frictional engagement.

[0475] Figure 79 (a) through 79(j) illustrate a method for assembling connector 1300. First, protective covers 1022, 1024 are assembled. Figure 79 (a)). Next, the protective covers 1022 and 1024 are assembled onto the collar 118 to surround the hollow needle 112. Figure 79 (b) The protective covers 1022 and 1024 can be secured in place by any suitable means (such as clips, adhesives, welding, etc.). Third, assemble the lower housing portion 102b onto the collar 118. Figure 79 (c)). Fourth, assemble the upper housing portion 102a onto the lower housing portion 102b. Figure 79 (d)). Fifth, assemble the second part 134b of the outer sleeve 134 to... Figure 79 (d) on the pre-assembled parts ( Figure 79 (e)). Sixth, assemble the first part 134a of the outer sleeve 134 onto the second part 134b of the outer sleeve 134. Figure 79 (f)). The first part 134a and the second part 134b can be assembled with each other by means of adhesive bonding, welding, clamping, etc. Seventh, a sterilization sealing system 1350 is provided. The sterilization sealing system 1350 includes a sterilization membrane 1351 and a clamping part 1352 as described above. The sterilization membrane 1351 is fixed to the lower housing part 102b to sterilize and seal the second diaphragm seal 110. The clamping part 1352 is slidably engaged with the outer sleeve 134. Then, the connector 1300 is provided with the sterilization sealing system 1350 ( Figure 79 (g)). Eighth, a transport cover 1370, optionally composed of polypropylene (PP) or low-density polyethylene (LDPE), is disposed above the proximal end 106 of the connector 1300. Figure 79 (h)). Ninth, a transport cap 1390, optionally composed of polypropylene (PP) or low-density polyethylene (LDPE), is disposed above the distal end 104 of the connector 1300. Figure 79 (i)). Tenth, add mark 1392 to the recessed area 1394 of the outer sleeve 134. Figure 79 (j)).

[0476] Figure 80 An embodiment of an interface board or container cover 1380 for use with any of the connectors described herein is shown. (See also: Regarding...) Figure 50 As described in (a) and 50(b), interface board 1380 is substantially similar to interface board 1150 and its associated operating mechanism.

[0477] Interface plate 1380 includes a base 1381 having sidewalls 1382 extending vertically from the base to a top wall 1384. The top wall 1384 is generally suspended above the sidewalls 1382 and is provided with a plurality of reinforcing ribs 1385 connecting the sidewalls 1382 to the lower surface of the top wall 1384. The base wall 1381 includes connecting elements (such as helical threads or clips) to allow interface plate 1380 to be connected to containers, receivers, etc. The top wall 1384 is provided with an outer circular edge 1386 and a centrally located diaphragm seal 1387 surrounded by a U-shaped upright positioning wall 1388. The diaphragm seal 1387 is a generally planar diaphragm seal (i.e., generally flat) recessed into the surface of the top wall 1384. A track 1390 is provided, extending radially outward from the open end of the U-shaped positioning wall 1388. A sterilization sealing system 1392 is further provided, which includes a clamping portion 1394 and a sterilization membrane 1396 attached to the clamping portion 1394. The sterilization membrane 1396 is disposed above the diaphragm seal 1387 to sterilize and seal the diaphragm seal, and the clamping portion 1394 is received within a track 1390 so that the clamping portion can slide within the track.

[0478] Now refer to, as follows Figures 63 to 77 The connector 1300 shown describes the interface plate 1380 in use, although any other connector described herein may also be used. First, the connector 1300 is positioned, accommodated, or otherwise held above the top wall 1384 of the interface plate 1380. The connector 1300 (particularly its sterile sealing system 1350) is engaged with the sterile sealing system 1392 of the interface plate 1380. Specifically, the protrusion 1364 of the sterile sealing system 1350 of the connector 1300 is engaged with the clamping portion 1394 of the sterile sealing system 1392 (particularly the hole 1397 within the clamping portion 1394). Next, simultaneously, the surface of the sterile membrane (not shown) of the sterile sealing system 1350 of the container 1300 is engaged with the surface of the sterile membrane 1398 of the interface plate 1380. For example, the sterilization membranes can be folded individually to form sterilization and connection surfaces, each sterilization surface positioned above its corresponding diaphragm seal 110, 1387, and the connection surface used for connection to a corresponding connection surface of another sterilized sealing system. The corresponding connection surfaces can be engaged and connected or coupled by any suitable means (e.g., adhesive). The upright wall 1388 facilitates positioning the sterilization membrane of connector 1300 onto the sterilization membrane 1396 of interface plate 1380.

[0479] Once the corresponding clamping portions 1352, 1394 and the corresponding sterilizing membrane are connected, an actuation system (not shown) can engage the sterilizing sealing system 1392 and / or the sterilizing sealing system 1350 of the connector 1300 to allow the corresponding clamping portions 1352, 1394 to slide along a radial axis. Typically, the corresponding clamping portions 1352, 1394 slide along an axis extending from the diaphragm seal 1387 and are generally defined by a track 1390 extending radially from the center of the top wall 1384. In this way, as each clamping portion 1352, 1394 slides away from the corresponding diaphragm seal 110, 1387, the corresponding sterilizing membrane is pulled, peeled off, or otherwise removed in a direction away from the corresponding diaphragm seal 110, 1387. In embodiments where the sterilizing membrane is folded, the specific removal step is determined by the fold geometry of the sterilizing membrane. Therefore, by removing each sterile membrane, each diaphragm seal 110, 1387 (i.e., the diaphragm seal of connector 1300 and the diaphragm seal of interface plate 1380) is allowed to engage with each other face-to-face and in a sterile or aseptic arrangement. Connector 1300 can then be operated as described above to provide fluid passage through the corresponding diaphragm seals 110, 1387, particularly by piercing the diaphragm seals 110, 1387 with a hollow needle 112, thereby fluidly connecting one fluid volume (e.g., the fluid volume connected to the end of connector 1300) to another fluid volume (e.g., the fluid volume connected to the end of interface plate 1380).

[0480] While several embodiments have been described herein, those skilled in the art will recognize that various aspects of each embodiment are disclosed in conjunction with any other embodiment. For example, any of the upper housing portion, lower housing portion, outer sleeve, collar, hollow needle, actuation mechanism, sterilization sealing system, etc., may be selected from the foregoing disclosure.

[0481] As those skilled in the art will understand, components such as connectors, receivers, interface boards, etc., can be made of any suitable material. For example: the outer sleeve can be made of polycarbonate, acrylonitrile butadiene styrene (ABS), or high-impact polystyrene sheet (HIPS); the sterile sealing system may include a clamping portion made of high-density polyethylene (HDPE) and / or a sterile membrane made of polyethylene (PE); the collar can be made of polycarbonate, acrylonitrile butadiene styrene (ABS), or high-impact polystyrene sheet (HIPS); the hollow needle can be made of stainless steel or another suitable biocompatible material or metal; the protective cover can be made of low-density polyethylene (LDPE), thermoplastic elastomer (TPE), silicone, etc.; the protective cover clip can be made of high-density polyethylene (HDPE); The lower housing portion can be composed of polycarbonate, acrylonitrile butadiene styrene (ABS), or high-impact polystyrene sheet (HIPS); the puncture-resistant seal of the lower housing portion can be composed of thermoplastic elastomer or silicone and / or can be co-molded with the lower housing portion; the upper housing portion can be composed of polycarbonate, acrylonitrile butadiene styrene (ABS), or high-impact polystyrene sheet (HIPS); the puncture-resistant seal of the upper housing portion can be composed of thermoplastic elastomer (TPE) or silicone and / or can be co-molded with the upper housing portion; and the transport cover and / or transport cap can be composed of polypropylene (PP), low-density polyethylene (LDPE), or combinations thereof. As described above, any combination of materials is also conceivable. In addition to being suitable for cell and / or gene therapy manufacturing, these materials offer a variety of manufacturing and processing advantages.

[0482] Generally, those skilled in the art will understand that the above embodiments have been described by way of example only and are not intended to be limiting, and that various substitutions and modifications can be made without departing from the scope of the invention as defined by the appended claims. Various modifications can be made to the detailed design described above, for example, changes may occur in shape, size, arrangement, assembly, sequence, etc.

Claims

1. A connector for introducing material into or removing material from at least one receiver, the connector comprising: - A housing extending between a distal end and a proximal end, the housing including at least a self-sealing diaphragm seal at the proximal end; - A hollow needle, which is at least partially installed within the housing, located between the distal and proximal ends of the housing, with a first end of the hollow needle connected to or capable of being connected to a first receiver at the distal end of the housing, and a second end of the hollow needle facing a self-sealing diaphragm seal at the proximal end of the housing; - An actuation mechanism that enables the hollow needle to pierce a self-sealing diaphragm seal at the proximal end of the housing, thereby forming communication through the self-sealing diaphragm seal, allowing material to be transferred through the connector. The actuation mechanism enables the hollow needle to be axially translated so that the hollow needle can pierce the self-sealing diaphragm seal at the proximal end of the housing.

2. The connector according to claim 1, wherein, The first end of the hollow needle is fluidly connected to or is fluidly connectable to the first receiver, and wherein the actuation mechanism allows the hollow needle to pierce the self-sealing diaphragm seal to fluidly connect the second end of the hollow needle to the second receiver.

3. The connector according to claim 1 or 2, wherein, The hollow needle is a double-ended hollow needle.

4. The connector according to claim 3, wherein, The near and far ends of the housing both include self-sealing diaphragm seals.

5. The connector according to claim 4, wherein, The double-ended hollow needle is installed inside the housing, and each end of the double-ended hollow needle faces the self-sealing diaphragm seal.

6. The connector according to claim 4, wherein, The actuation mechanism is configured to enable the double-headed hollow needle to pierce the self-sealing diaphragm seal at the proximal and distal ends of the housing.

7. The connector according to claim 3, wherein, The actuation mechanism further includes a retractable housing, wherein at least a portion of the housing is retractable between the proximal and distal ends to allow the double-ended hollow needle to pierce a self-sealing diaphragm seal at the distal end of the housing.

8. The connector according to claim 7, wherein, The retractable shell includes an upper shell portion and a lower shell portion, the upper shell portion being axially movable relative to the lower shell portion along a central longitudinal axis in order to retract relative to the lower shell portion.

9. The connector according to claim 8, wherein, The upper housing portion includes at least one actuable lug configured to move the upper housing portion along the central longitudinal axis.

10. The connector of claim 8 or claim 9, further comprising a collar operably coupled to the double-ended hollow needle, the collar including at least one actuable lug configured to move the collar along the central longitudinal axis.

11. The connector according to claim 9, further comprising a collar operably coupled to the double-ended hollow needle, the collar including at least one actuable lug configured to move the collar along the central longitudinal axis, and the connector further comprising an outer sleeve including a sidewall having a first slot and a second slot diametrically opposed to the first slot, the first slot receiving the first actuable lug of the upper housing portion and the first actuable lug of the collar, the second slot receiving the second actuable lug of the upper housing portion and the second actuable lug of the collar.

12. The connector according to claim 1, wherein, The actuation mechanism includes an outer sleeve configured such that rotation of at least a portion of the outer sleeve causes axial translation of the hollow needle.

13. The connector according to claim 12, wherein, The outer sleeve is configured such that it creates a releasable locking engagement between the proximal end of the outer sleeve of the connector and a portion of the second receiver.

14. The connector according to claim 3, wherein, The first end of the double-ended hollow needle includes a closed end with a pen tip and at least one port adjacent to the closed end with a pen tip, and the second end of the double-ended hollow needle includes a beveled open end.

15. The connector according to claim 3, wherein, The double-ended hollow needle is biasedly mounted within the housing; and wherein the actuation mechanism includes an outer sleeve configured such that at least a portion of rotation of the outer sleeve causes axial translation of the double-ended hollow needle to pierce at least one self-sealing diaphragm seal, thereby forming communication through the at least one self-sealing diaphragm seal.

16. The connector according to claim 3, wherein, The double-headed hollow needle is biasedly mounted in a direction toward the proximal end of the housing via a first biasing mechanism.

17. The connector according to claim 16, wherein, The double-headed hollow needle is biased and mounted in a direction toward the distal end of the housing via a second biasing mechanism.

18. The connector according to claim 17, wherein, 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.

19. The connector according to claim 17, wherein, The first biasing mechanism provides a first biasing force, and the second biasing mechanism provides a second biasing force, wherein the first biasing force is greater than the second biasing force.

20. The connector according to claim 1, wherein, The connector further includes a sterile sealing system comprising a sterile membrane and a clamping portion, the sterile membrane being disposed above a self-sealing diaphragm seal at each end of the connector housing and operably coupled to the clamping portion.

21. The connector according to claim 20, wherein, The clamping portion is slidably operably connected to the connector, such that the clamping portion can slide between a first configuration and a second configuration, in which the sterilizing membrane is disposed above each self-sealing diaphragm seal, and in the second configuration, the sterilizing membrane is removed from each self-sealing diaphragm seal.

22. The connector according to claim 1, wherein, The second receiver is connected to or can be connected to the housing of the connector.

23. The connector according to claim 1, wherein, The communication via the self-sealing diaphragm seal includes communication between a first receiver that is connected or capable of being connected and a second receiver that is connected or capable of being connected, such that material can be transferred between the first receiver and the second receiver via the connector.

24. A sterile connection system, comprising: - The connector according to any one of claims 1-23; - A first receiver, detachably coupled to one end of the connector, wherein the first receiver is connected to a first end of the hollow needle; and - A second receiver is detachably coupled to one end of the connector, wherein the second receiver is connected to the second end of the hollow needle.

25. A method for connecting two receivers, comprising the following steps: - Provide a connector according to any one of claims 1 to 23, - Connect the distal end of the connector housing to the first receiver, such that the first receiver is connected to the first end of the hollow needle; - The proximal end of the connector housing is detachably connected to a second receiver including a self-sealing diaphragm seal, such that the self-sealing diaphragm seal of the connector is coaxially aligned with the self-sealing diaphragm seal of the second receiver. - Actuate the hollow needle to pierce the self-sealing diaphragm seal of the connector housing and through the self-sealing diaphragm seal of the second receiver, thereby connecting the first receiver and the second receiver.

26. A sterile connector for introducing material into or removing material from at least one receiver, said sterile connector comprising: - A housing extending between a distal end and a proximal end, the housing including a first self-sealing diaphragm seal at the distal end and a second self-sealing diaphragm seal at the proximal end; - A hollow needle, which is installed inside the housing between the distal end and the proximal end, with a first end of the hollow needle facing the first self-sealing diaphragm seal and being connectable to the first receiver, and a second end of the hollow needle facing the second self-sealing diaphragm seal and being connectable to the second receiver; as well as - An actuation mechanism that acts on the housing or hollow needle to enable the hollow needle to pierce the first self-sealing diaphragm seal and the second self-sealing diaphragm seal, thereby forming a sterile connection through the self-sealing diaphragm seal, allowing material to be transferred through the sterile connector.

27. A sterile packaging or sterile container comprising a connector according to any one of claims 1 to 23 or a sterile connector according to claim 26.

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