connector

Abstract

The present invention relates to a connector including a housing extending between a distal end and a proximal end; a hollow needle at least partially mounted within the housing, a first end of the hollow needle connected or connectable to a first container and a second end of the hollow needle facing a pierceable seal; an actuation mechanism configured to cause relative movement between the hollow needle and the pierceable seal to enable the hollow needle to pierce the pierceable seal; and a locking mechanism that, in a first configuration, prevents the actuation mechanism from causing relative movement between the hollow needle and the pierceable seal and, in a second configuration, enables the actuation mechanism to cause relative movement between the hollow needle and the pierceable seal.

Description

[Technical field]

[0001] The present invention relates to connectors, e.g., sterile connectors. More particularly, the present invention relates to connectors for introducing or extracting material from at least one container. The connectors described herein may form part of a biological processing device, such as a cell and / or gene therapy manufacturing device. [Background technology]

[0002] Biological processing methods, particularly those used in the manufacture of cell and / or gene therapy products, are often complex and require manual or semi-automated steps across multiple devices. The systems used in the various steps of manufacturing a cell-based therapeutic product (CTP), also called unit operations, may include multiple devices for various functions. These various functions may include, for example, cell collection, separation, selection, expansion, proliferation, washing, storage, or propagation. Unit operations may vary greatly based on the manufacturing model (i.e., autologous or allogeneic), cell type, application, among other factors. Moreover, cells are "living" and are sensitive to even the slightest manipulation or change of conditions, particularly during transfer between various devices.

[0003] Cultivation or processing of cells typically requires the use of a device that holds the cells in a medium suitable for growth. Such known devices include shake flasks, roller bottles, T-flasks, bags, bioreactors, etc. Subsequently, an addition step to the device or a removal step from the device may be desirable. For example, the addition of medium, culture nutrients, cytokines, recombinant media, or similar substances may be desirable to support the culture or processing method. Similarly, it may be desirable to remove exhausted medium, such as in a "wash" step, or to take a sample from the device.

[0004] Thus, during biological processing methods, such as cell and / or gene therapy manufacturing, it is necessary to connect one device to another to allow fluid communication between the devices. Furthermore, it is often desirable to achieve sterile or aseptic connections between such devices, and sterile separation once material transfer is complete.

[0005] One solution is to provide a needle-based connector to allow communication between the two devices to be connected through the needle-based connector, however, one drawback of such needle-based connectors is the need to mitigate or at least reduce needlestick injuries, such injuries not only being harmful to the user who may be exposed to harmful biological agents, but also compromising the sterility of the connection. Summary of the Invention [Problem to be solved by the invention]

[0006] It is therefore an object of the present invention to address one of the shortcomings associated with known connectors, particularly sterile needle-based connectors. In particular, but not by way of limitation, one object of the present invention is to mitigate, obviate or otherwise reduce needlestick injuries when handling needle-based connector systems. [Means for solving the problem]

[0007] According to one aspect of the invention, there is provided a connector for introducing or extracting material from at least one container, comprising: a housing extending between a distal end and a proximal end; a hollow needle at least partially mounted within the housing between a distal end and a proximal end, a first end of the hollow needle connected or connectable to a first container and a second end of the hollow needle facing the pierceable seal; an actuation mechanism configured to cause relative movement between the hollow needle and the pierceable seal to enable the hollow needle to pierce the pierceable seal, thereby creating communication through the pierceable seal; a locking mechanism operable between a first configuration in which the locking mechanism prevents the actuation mechanism from causing relative movement between the hollow needle and the pierceable seal, and a second configuration in which the locking mechanism allows the actuation mechanism to cause relative movement between the hollow needle and the pierceable seal; A connector is provided.

[0008] This provides the advantage that upon actuation of the locking mechanism, the hollow needle exclusively pierces the pierceable seal. That is, in the first state position, the hollow needle is prevented from piercing the pierceable seal. In the second state position, when the locking mechanism is actuated by a user or machine, the hollow needle is enabled to pierce the pierceable seal and form communication through the pierceable seal. Thus, needlestick injuries may be mitigated or at least reduced during use of the needle-based connector.

[0009] In some embodiments, the pierceable seal is a self-sealing seal. In some embodiments, the pierceable seal is a septum seal. In some embodiments, the pierceable seal is an airtight seal. In some embodiments, the housing includes the pierceable seal. In other embodiments, a portion of the actuation mechanism may include the pierceable seal.

[0010] In one embodiment, the actuation mechanism includes a collapsible sleeve assembly, at least a portion of which is foldable between the proximal and distal ends of the housing to enable the hollow needle to pierce the pierceable seal, thereby forming communication through the pierceable seal.

[0011] Thus, in one embodiment, the locking mechanism is operable between a first configuration in which the locking mechanism prevents the collapsible housing from collapsing and a second state position in which the locking mechanism allows the collapsible housing to collapse and permit the hollow needle to pierce the pierceable seal.

[0012] In some embodiments, the collapsible sleeve assembly may include a portion of a housing, hi some embodiments, the housing or a portion thereof may be configured to cause the collapsible sleeve assembly to collapse.

[0013] In one embodiment, the collapsible sleeve assembly includes a movable sleeve portion and a stationary sleeve portion, the movable sleeve portion being axially movable relative to the stationary sleeve portion along a central longitudinal axis to collapse relative to the stationary sleeve portion.

[0014] Thus, in one embodiment, the locking mechanism is operable between a first configuration in which the locking mechanism prevents axial movement of the movable sleeve portion and a second state position in which the locking mechanism allows axial movement of the movable sleeve portion to enable the hollow needle to pierce the pierceable seal.

[0015] In certain embodiments, the movable sleeve portion includes at least one actuatable element configured to be operatively engaged by an actuation system. In certain embodiments, the at least one actuatable element includes a protrusion, shoulder, projection, catch, connecting element, fastener, loop, etc. The at least one actuatable element may be hollow. In some embodiments, the movable sleeve portion includes a pair of actuatable elements.

[0016] In certain embodiments, the movable sleeve portion includes a pierceable seal. In some embodiments, the movable sleeve portion includes a pierceable seal at its distal end adjacent or coinciding with the distal end of the housing.

[0017] In one embodiment, the locking mechanism includes a clip slidably disposed within a lateral slot of the movable sleeve portion, and in a first state position, the movable clip is engaged with a portion of the stationary sleeve portion, and in a second state position, the movable clip is released from the portion of the stationary sleeve portion.

[0018] In certain embodiments, the locking element includes a clip slidably disposed within a hollow actuatable element of the movable sleeve portion.

[0019] In an embodiment, the clip is biased towards or to the first state position by a biasing element.

[0020] This provides the advantage that following actuation of the actuation mechanism and therefore the hollow needle, the locking mechanism returns to the first or locked position, thereby mitigating or at least reducing needle stick injuries.

[0021] In some embodiments, the clip includes at least one spring arm. In some embodiments, the clip is provided with a pair of spring arms. The or each spring arm may be deflectable or resilient.

[0022] In certain embodiments, the hollow needle is a double ended hollow needle. The double ended hollow needle may include a piercing end at each end thereof.

[0023] In some embodiments, the stationary sleeve portion includes a pierceable seal and the double-ended hollow needle is disposed between each of the pierceable seals, i.e., in some embodiments, the double-ended hollow needle is disposed between the pierceable seal of the movable sleeve portion and the pierceable seal of the stationary sleeve portion, i.e., in some embodiments, each end of the double-ended hollow needle faces a pierceable seal.

[0024] In one embodiment, the actuation mechanism is configured to cause relative movement between the double-ended hollow needle and each of the pierceable seals and to enable the double-ended hollow needle to pierce each of the pierceable seals, thereby forming communication through each of the pierceable seals.

[0025] In certain embodiments, the actuation mechanism further includes a collar operably coupled to the hollow needle, the collar being axially movable along the central longitudinal axis.

[0026] This provides the advantage that the translational movement of the hollow needle can be controlled along the central longitudinal axis.

[0027] In one embodiment, the locking mechanism is operable between a first configuration in which the locking mechanism prevents translational movement of the collar along the central longitudinal axis and a second configuration in which the locking mechanism allows translational movement of the collar along the central longitudinal axis.

[0028] In some embodiments, the collar includes at least one actuatable element configured to be operatively engaged by the actuation system. In some embodiments, the at least one actuatable element includes a protrusion, shoulder, projection, catch, interlocking element, fastener, loop, etc. The at least one actuatable element can be hollow. In some embodiments, the collar includes a pair of actuatable elements.

[0029] In one embodiment, the locking mechanism includes a clip slidably disposed within a lateral slot of the collar, and in a first state position, the clip is engaged with a portion of the stationary sleeve portion, and in a second state position, the movable clip is released from the portion of the stationary sleeve portion.

[0030] In some embodiments, the collar includes a clip that is slidably disposed within a hollow actuatable element of the collar.

[0031] In an embodiment, the clip is biased towards the first state position by a biasing element.

[0032] This provides the advantage that following actuation of the actuation mechanism and therefore the hollow needle, the locking mechanism returns to the first or locked position, thereby mitigating or at least reducing needle stick injuries.

[0033] In some embodiments, the clip includes at least one spring arm. In some embodiments, the clip is provided with a pair of spring arms. The or each spring arm may be deflectable or resilient.

[0034] According to another aspect of the present invention, A connector as described herein; an actuation system configured to operatively engage the locking mechanism to enable movement of the locking mechanism between the first and second configurations; A system is provided that includes:

[0035] In certain embodiments, the actuation system is further configured to actuate the actuation mechanism to enable the hollow needle to pierce the pierceable seal and form communication through the pierceable seal.

[0036] In one embodiment, the actuation system includes at least one prong configured to operably engage the locking mechanism to enable movement of the locking mechanism between the first and second configurations.

[0037] In an embodiment, at least one prong of the actuation system is configured to operatively engage a clip disposed within a lateral slot of the movable sleeve portion or collar.

[0038] In some embodiments, at least one prong of the actuation system is further configured to actuate an actuatable element of the movable sleeve portion or collar, hi some embodiments, at least one prong of the actuation system is further configured to translate the movable sleeve portion or collar by engaging the actuatable element.

[0039] In an embodiment, the actuation system includes a first prong configured to operably engage a clip disposed in the lateral slot of the movable sleeve portion and a second prong configured to operably engage a clip disposed in the lateral slot of the collar. The first prong may be provided as a pair of prongs to operably engage the pair of clips. The second prong may be provided as a second pair of prongs to operably engage the pair of clips.

[0040] In some embodiments, the first prong is further configured to actuate an actuatable element of the movable sleeve portion. In some embodiments, the first prong of the actuation system is further configured to translate the movable sleeve portion by engaging the actuatable element. In some embodiments, the second prong is further configured to actuate an actuatable element of the collar. In some embodiments, the second prong of the actuation system is further configured to translate the collar by engaging the actuatable element.

[0041] According to another aspect of the invention, there is provided a method of connecting two containers, comprising the steps of: Providing a connector as described herein; Providing an actuation system as described herein; connecting a distal end of the housing of the connector to a first container such that the first container is connected to a first end of the hollow needle; releasably connecting a proximal end of the housing of the connector to a second container including a pierceable seal such that the pierceable seal of the connector is coaxially aligned with the pierceable seal of the second container; operatively engaging a locking feature of the connector using an actuation system to operate the locking feature from a first configuration to a second configuration; actuating the hollow needle to pierce the pierceable seal of the connector and to pierce the pierceable seal of the second container, thereby connecting the first container and the second container; A method is provided, which includes:

[0042] In an embodiment, the method comprises: deactivating the hollow needle to stop piercing the pierceable seal of the connector, thereby separating the first container and the second container; releasing the actuation system from the locking mechanism of the connector to actuate the locking mechanism from the second configuration to the first configuration; Further includes:

[0043] Reference is now made to the drawings, which depict one or more embodiments described in this disclosure. However, it will be understood that other embodiments not shown in the drawings will fall within the scope of this disclosure. Like numbers used in the figures refer to like components, steps, etc. However, it will be understood that the use of numbers to refer to components in a given figure is not intended to limit components in another figure that are numbered the same or different in nature. The figures are shown for illustrative purposes and not limiting. Schematic drawings shown in the figures are not necessarily drawn to scale. [Brief description of the drawings]

[0044] [Figure 1] 1 is a perspective view of a connector according to an embodiment of the present invention. [Diagram 2] FIG. 2 is an exploded view of the connector of FIG. 1. [Diagram 3]FIG. 2 is a detailed view of the actuation mechanism of the connector of FIG. 1. [Figure 4] FIG. 2 is a cross-sectional view of the connector of FIG. 1. [Diagram 5] 2 is a perspective view of the connector of FIG. 1: (a) with the locking feature in a first configuration, (b) with the locking feature in a second configuration, and (c) after piercing of the first pierceable seal. [Figure 6] 2A-2D are partial cutaway side views of the connector of FIG. 1 with the locking mechanism in a first configuration, (b) the locking mechanism in a second configuration, (c) after piercing of the first pierceable seal, and (d) after piercing of the second pierceable seal. [Figure 7] 2A-2D are partial cutaway rear views of the connector of FIG. 1 with the locking mechanism in a first configuration, (b) with the locking mechanism in a second configuration, (c) after piercing of the first pierceable seal, and (d) after piercing of the second pierceable seal. [Figure 8] 2A-2C are side views of the clip of the locking mechanism shown in FIG. 1 in: (a) a first configuration; and (b) a second configuration. [Figure 9] FIG. 2 is a diagram of an actuation system for enabling movement of the connector of FIG. 1 in use. [Figure 10] 10A through 10E are diagrams illustrating the use of the actuation system of FIG. 9 to enable operation of the connector of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] The described example embodiments relate to connectors for introducing or extracting materials from at least one container. In particular, some embodiments relate to connectors that are sterile connectors, or more particularly, connectors that maintain a sterile environment during material transfer. The terms "sterile" and "aseptic" are interchangeable. References to fluids in the detailed description are not intended to limit the scope of protection to such materials. As will be appreciated by those of skill in the art, the fluids described herein are merely examples of suitable materials for use with the described connectors. Similarly, although references may be made to containers, blood collection tubes, and the like, such references in the detailed description are not intended to limit the scope of protection of such containers or tubes. As will be appreciated by those of skill in the art, containers, blood collection tubes, and the like are described herein as merely examples of suitable containers.

[0046] In the following description, certain terminology is used merely for convenience and is not limiting. The words "upper" and "lower" designate orientations within the referenced drawings and relate to the components being described when assembled and attached. The words "inner," "inwardly," and "outer," as well as "outwardly," refer to directions toward and away from a designated centerline or geometric center (e.g., central axis) of the element being described, respectively, and their particular meanings are readily apparent from the context of the description. Additionally, the terms "proximal" (i.e., closer) and "distal" (i.e., away) designate positions relative to an axis or attachment point.

[0047] Additionally, as used herein, the terms "connected," "fixed," "coupled," and the like are intended to include a direct connection between two members where no other members are interposed between them, and an indirect connection between the members where one or more other members are interposed between them. The terminology includes the words specifically mentioned above, derivatives thereof, and words of similar import.

[0048] Further, unless otherwise specified, the use of ordinal adjectives such as "first," "second," "third," etc. is indicated merely to refer to various instances of similar objects, and does not imply that the objects so described must be in a particular order, temporally, spatially, sequentially, or in any other manner. Like reference numerals are used throughout to denote like features.

[0049] FIG. 1 shows a connector 10 including a housing 100 extending between a distal end and a proximal end. The housing 100 includes an outer cover 120 having a flat side wall, a curved front wall, a portion of an actuation mechanism, and a stationary sleeve portion 160, which will be described below. The stationary sleeve portion 160 is provided with a pair of magnets 168 for cooperation with cooperating magnets on an actuation system, which will be further discussed below, to provide tactile feedback to the user during installation. The connector 10 also includes a cap 140 disposed at the proximal end of the housing 100 to enclose a base of the connector 10. The connector 10 also includes a receptacle receiving portion 122, as part of a movable sleeve portion, which will be described below, that is substantially cylindrical and includes an internally threaded portion 214. The receptacle receiving portion 122 is also provided with an anti-rotation screw 216 designed as a ratchet mechanism that interacts with a cooperating element on a received receptacle (not shown).

[0050] Figure 2 shows an exploded view of the connector 10 of Figure 1. As shown, the connector 10 is comprised of the outer cover 120 and the cap 140 previously described. The connector 10 also includes a double ended hollow needle 240 operably connected to a collar 260, as described below. The hollow needle 240 is actuated by an actuation mechanism including a movable sleeve portion 200 and a stationary sleeve portion 160, in this embodiment configured as a collapsible sleeve mechanism. The connector 10 is also provided with a sliding drawer 300 slidably connected to the stationary sleeve portion 160 and covered by the cap 140 during transport of the connector 10.

[0051] 2-4, the actuation mechanism is described as follows: A movable sleeve portion 200 is provided which includes a pair of laterally extending hollow projections 202, 204, each of which includes a laterally extending slot 206, 208. A clip 220 is provided within the hollow projections 202, 204, which is slidably disposed within each hollow projection 202, 204. Each clip 220 is provided with a projection 222 which extends through a respective slot 206, 208 of projections 202, 204. As will become apparent from the remaining description, clip 220 serves as a locking mechanism to prevent piercing of the pierceable seal by a needle 240 prior to use. The clip 220 is provided with a pair of spring arms 224, described in further detail below, which in a first configuration extend through recesses in the hollow projections 202, 204 adjacent the hollow projections' open ends 210, 212. The projections 202, 204 are accessible, i.e. at their open ends 210, 212, through a pair of longitudinally extending slots 162 (see FIG. 1) in the stationary sleeve portion 160.

[0052] 5(a) through 5(c), the hollow projections 202, 204 include a rib portion 218 having a varying thickness. Specifically, the rib portion 218 has a greater thickness adjacent the open ends 210, 212 and a lesser thickness at the opposite end. In this manner, tactile feedback is provided to the user when the connector is placed onto an actuation system, as described below.

[0053] A collar 260 is provided that includes a pair of laterally extending hollow projections 262, 264. Collar 260 is operatively coupled to hollow needle 240, for example, by friction fit, push fit, adhesive, etc. Projections 262, 264 are accessible through a pair of longitudinally extending slots 162 (see FIG. 1) in stationary sleeve portion 160.

[0054] Although not shown, the projections 262 , 264 of the collar 260 may include clips in addition to or as an alternative to the clips 220 provided within the projections 202 , 204 of the movable sleeve portion 200 .

[0055] 1 and 2, two gaiters 280, 290 are provided, one surrounding each side of hollow needle 240, one on either side of collar 260. That is, a first gaiter 280 extends from a first side of collar 260 toward the distal end of connector 10, and a second gaiter 290 extends from a second, opposite side of collar 260 toward the proximal end of connector 10. Gaiters 280, 290 act as a sterile barrier during use to ensure a sterile environment for needle 240.

[0056] Finally, with reference to Figures 2 and 3, a sliding drawer 300 is provided which is slidably connected to and slidable relative to the stationary sleeve portion (see Figure 2). The sliding drawer 300 includes a front portion 302 from which rails extend and which, in use, is received in corresponding slots in the stationary sleeve portion. The sliding drawer 300 is coupled to a sterile seal 304 by heat welding. The sterile seal 304 is provided as a folded piece of polymeric material which ensures sterility of the pierceable seal over which it is provided.

[0057] In addition to those features already described, the connector 10 includes, inter alia, a first pierceable seal 282 formed in the movable sleeve portion 200 toward the distal end of the connector 10 and a second pierceable seal 292 formed in the stationary sleeve portion 160 (see FIG. 2) toward the proximal end of the connector 10. Each pierceable seal 282, 292 encloses the hollow needle 240 therebetween, such that each end of the hollow needle 240 faces a pierceable seal 282, 292 at a respective end. Prior to use, the hollow needle 240 faces each pierceable seal 282, 292 and does not protrude through them. After actuation of the connector, the needle 240 is caused to pierce each pierceable seal 282, 292 to form a connection between the two receptacles, each of which is disposed proximate to each pierceable seal 282, 292.

[0058] With further reference to Figures 5(a) through 5(c), the operation of the actuation and locking mechanism of the actuation mechanism in use is illustrated. In particular, as shown in these figures, the clip 220 (see Figure 4) of the hollow projections 202, 204 is moved laterally within the projections 202, 204, and the projections 222 move within the respective slots 206, 208. The clip 220 (see Figure 4) is moved between a first configuration (Figure 5(a)) and a second configuration (Figure 5(b)). As described in more detail with respect to Figure 6, in the second configuration (Figure 5(b)), the movable sleeve portion 200 is allowed to translate longitudinally downwardly, toward the proximal end of the connector, to allow piercing of the first pierceable seal 282 by the needle 240 (see Figure 4).

[0059] Referring now to Figures 6(a) to 6(d) and 7(a) to 7(d), the operation of the connector 10 will be described. The connector 10 is provided in a locked state, also known as a first configuration, as shown in Figures 6(a) and 7(a). As shown in Figure 6(a), the protrusion 222 of the clip 220 (Figures 2 to 4) is in engagement with the shoulder 164 of the stationary sleeve portion 160. In this configuration, the protrusion 222 abuts the shoulder 164 causing the lock, so that the movable sleeve portion 200 cannot move longitudinally relative to the stationary sleeve portion 160.

[0060] 6(b) and 7(b), clip 220 is moved laterally within projections 202, 204, thereby moving protrusion 222 along slots 206, 208. In this manner, protrusion 222 is released from shoulder 164 of stationary sleeve portion 160. Protrusion 222 is disposed within longitudinal slot 166 and therefore does not block longitudinal translational movement of movable sleeve portion 200.

[0061] 6(c) and 7(c), the movable sleeve portion 200 is translated axially, i.e., downwardly, toward the proximal end of the connector 10, thereby allowing the hollow needle 240, which is held stationary during operation, to pierce through the first pierceable seal 282 (see FIG. 4). This achieves connection to a receiver received at the distal end of the connector 10, within the receiver receiving portion 122 (see FIG. 1).

[0062] 6(d) and 7(d), the movable sleeve portion 200 is caused to continue in its axial trajectory while the collar 260 is simultaneously caused to translate axially, i.e., downwardly, toward the proximal end of the connector 10. In this manner, the hollow needle 240 continues to pierce the first pierceable seal 282, i.e., the seal of the movable sleeve portion 200, and is caused to pierce through the second pierceable seal 292 of the stationary sleeve portion 160, thereby achieving end-to-end communication of the connector 10. Thus, although not shown, two containers are connected at each end of the connector 10.

[0063] 8(a) and 8(b) show detailed views of the clip 220, which may be provided within the hollow projections 202, 204, 262, 264 of the movable housing portion 200 and / or collar 160. As shown, the clip 220 includes a protrusion 222 extending substantially perpendicular to the body of the clip 220. The clip 220 is also provided at one end with a pair of spring arms 224 that act as a biasing means. In use, as the clip 220 moves within the projections 202, 204 (see FIGS. 5(a) and 5(b)), the spring arms 224 are compressed and compressed into the configuration shown in FIG. 8(b). In the configuration shown in FIG. 8(b), the spring arms 224 are compressed and thus the spring force biases the clip 220 towards the first configuration (i.e., as shown in FIG. 8(a)). Thus, the force acting on clip 220 to move it to the second configuration is removed and clip 220 is biased back to the first configuration. Spring arms 224 are also each provided with a lip 224a to provide a gripping surface on a portion of the actuation system, described in more detail below. Alternatively, or in addition, lip 224a may be positioned to engage a recess or groove in a portion of the actuation system. In this manner, clip 220 may be pulled out by the actuation system upon release of the locking mechanism. Additionally, this interaction may provide tactile feedback to the user when installing / removing the connector onto the actuation system.

[0064] 9 illustrates an actuation system 420 for actuating the connector 10, and in particular its locking and actuation mechanisms, in use. As shown in FIG. 9, the actuation system 420 is provided as part of the incubator apparatus 400. The actuation system 420 includes a first pair of prongs 422, 424 and a second pair of prongs 426, 428. The first pair of prongs 422, 424 are further configured to engage the projections 202, 204 of the movable sleeve portion 200 and to engage the clip 220 received therein. In particular, when a user places the connector 10 on the actuation system 420, the first pair of prongs 422, 424 move the clip 220 from a first configuration to a second configuration. Each prong 422, 424 may include a recess or groove (not shown) that is positioned to engage lip 224a (see FIGS. 8(a) and 8(b)) of clip 220 to engage between prong 422, 424 and clip 220 and also to provide tactile feedback to a user when installing / removing connector 10 onto actuation system 420. Actuation system 420 is then operable to move movable sleeve portion 200, i.e., to cause axial translation thereof to cause piercing of first pierceable seal 282 as previously described.

[0065] Additionally, the actuation system 420 includes a second pair of prongs 426, 428 configured to engage the projections 262, 264 of the collar 260. The second pair of prongs 426, 428 may similarly engage any clips within such projections 262, 264. The actuation system 420 is then operable to move the collar 260, i.e., cause axial translation thereof, to cause piercing of the second pierceable seal 292 as previously described.

[0066] 10(a) through 10(e) illustrate the use of the actuation system 420 to actuate and operate the connector 10 during use. FIG. 10(a) illustrates the actuation system 420 in detail with the prong 422 engaged with the clip 220 within one of the hollow projections of the movable sleeve portion 200. Also shown is the gaiter 280 covering the needle and the sliding drawer 300. With further reference to FIGS. 8(a) and 8(b), the prong 422 engages the clip 220 such that the lip 224a of the clip 220 engages a recess or groove in the prong 422 when the spring arm 224 folds inward during engagement. In FIG. 10(a), the clip 220 remains in a first configuration. FIG. 10(b) illustrates the prong 422 inserted into the projection of the movable sleeve portion 200 to move the clip 220 to a second configuration for movement (see FIGS. 6 and 7 above). FIG. 10(c) illustrates actuation of the sliding drawer 300 to remove the sterile seal (see FIG. 2) from the second pierceable seal 292 before the needle is actuated. The actuation system may provide a force to the sliding drawer 300 to move it to the position shown. FIG. 10(d) illustrates the prongs 422 acting on the movable sleeve portion 200 to translate it downward, i.e., toward the proximal end of the connector, and thus pierce the first pierceable seal with the needle (see FIGS. 6 and 7). FIG. 10(e) illustrates the continued trajectory of movement, with the prongs 426, 428 (see FIG. 9) also acting on a collar (not shown) to move the hollow needle 240 through the second pierceable seal, as described in more detail above. Material may then be transferred through the connector. Once transfer has occurred, the steps may be reversed to allow the connector to be removed from the actuation system.

[0067] As will be appreciated by those skilled in the art, the connector components, receptacles, interface locations, etc. may be constructed of any suitable material. For example, the housing may be constructed of polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS); the sterile seal may be constructed of polyethylene (PE); the collar may be constructed of polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS); the hollow needle may be constructed of stainless steel or another suitable biocompatible material or metal and may have any suitable gauge; the gaiter may be constructed of low density polyethylene (LDPE), thermoplastic elastomer (TPE), silicone, etc; the gaiter clip may be constructed of high density polyethylene (HDPE); the stationary sleeve portion may be constructed of polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS); the hollow needle may be constructed of stainless steel or another suitable biocompatible material or metal and may have any suitable gauge; the gaiter may be constructed of low density polyethylene (LDPE), thermoplastic elastomer (TPE), silicone, etc. ... The stationary sleeve portion may be constructed of polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS); the pierceable seal of the stationary sleeve portion may be constructed of thermoplastic elastomer, or silicone, and / or may be integrally molded with the stationary sleeve portion; the movable sleeve portion may be constructed of polycarbonate, acrylonitrile butadiene styrene (ABS), high impact polystyrene sheet (HIPS); the pierceable airtight seal of the upper housing portion may be constructed of thermoplastic elastomer (TPE), or silicone, and / or may be integrally molded with the movable sleeve portion; the cap may be constructed of polypropylene (PP), low density polyethylene (LDPE), or combinations thereof. Also, any combination of materials is contemplated as discussed above. Such materials, in addition to being suitable for cell and / or gene therapy manufacturing, offer multiple manufacturing and processing advantages.

[0068] In general, it will be appreciated by those skilled in the art that the above embodiments are described merely by way of example and not in any limiting sense, and that various changes and modifications are possible without departing from the scope of the present invention as defined by the appended claims. Various modifications to the detailed designs described above are possible, for example, variations may exist in shape, size, arrangement, assembly, sequence, etc. [Explanation of symbols]

[0069] 10 Connectors 100 Housing 120 Outer cover 122 Container receiving part 140 Cap 160 Stationary sleeve part 162, 206, 208 Slots 164 Shoulder 166 Longitudinal Slot 168 Magnet 200 Movable sleeve part 202, 204 (of the movable sleeve) hollow protrusion 210, 212 open end 214 Inner thread part 216 Anti-rotation screw 218 Rib section 220 (of central projections 202, 204) clip 222 Protrusion 224 Spring Arm 224a (Spring arm) lip 240 Double-ended hollow needle 260 Color 262, 264 (color) protrusions 280 First Gaiter 282 First pierceable seal 290 Second Gaiter 292 Second Pierceable Seal 300 Sliding drawer 302 (Front part of sliding drawer) 304 Sterile Seal 400 Incubator Equipment 420 Actuation System 422, 424 First pair of prongs 426, 428 Second pair of prongs

Claims

1. A connector for introducing or extracting material from at least one container, comprising: a housing extending between a distal end and a proximal end; a hollow needle at least partially mounted within the housing between the distal end and the proximal end, a first end of the hollow needle connected or connectable to a first container and a second end of the hollow needle facing a pierceable seal; an actuation mechanism configured to cause relative movement between the hollow needle and the pierceable seal to enable the hollow needle to pierce the pierceable seal, thereby creating communication through the pierceable seal; a locking mechanism operable between a first configuration in which the actuation mechanism prevents relative movement between the hollow needle and the pierceable seal and a second configuration in which the locking mechanism allows the actuation mechanism to cause said relative movement between the hollow needle and the pierceable seal; Including, the connector.

2. 2. The connector of claim 1, wherein the actuation mechanism includes a collapsible sleeve assembly, at least a portion of which is foldable between the proximal and distal ends of the housing to enable the hollow needle to pierce the pierceable seal, thereby forming communication through the pierceable seal.

3. 3. The connector of claim 2, wherein the foldable sleeve assembly includes a movable sleeve portion and a stationary sleeve portion, the movable sleeve portion being axially movable along a central longitudinal axis relative to the stationary sleeve portion to fold relative to the stationary sleeve portion.

4. The connector of claim 3 , wherein said movable sleeve portion includes said pierceable seal.

5. 5. The connector of claim 3 or 4, wherein the locking mechanism includes a clip slidably disposed within a lateral slot of the movable sleeve portion, and in a first state position, the movable clip is engaged with a portion of the stationary sleeve portion, and in a second state position, the movable clip is released from the portion of the stationary sleeve portion.

6. The connector of claim 5 , wherein the clip is biased toward the first state position by a biasing element.

7. The connector of claim 6 , wherein the clip includes at least one spring arm.

8. The connector according to claim 1 , wherein the hollow needle is a double-ended hollow needle.

9. 9. The connector of claim 8 when dependent on any one of claims 4 to 7, wherein the stationary sleeve portion includes pierceable seals, and the double ended hollow needles are disposed between each pierceable seal.

10. 10. The connector of claim 9, wherein the actuation mechanism is configured to cause relative movement between the double-ended hollow needle and each of the pierceable seals to enable the double-ended hollow needle to pierce each of the pierceable seals, thereby forming communication through each pierceable seal.

11. The connector of claim 1 , wherein the actuation mechanism further comprises a collar operably coupled to the hollow needle, the collar being axially movable along the central longitudinal axis.

12. 12. The connector of claim 11, wherein the locking mechanism is operable between a first configuration in which the locking mechanism prevents translational movement of the collar along the central longitudinal axis and a second configuration in which the locking mechanism allows the translational movement of the collar along the central longitudinal axis.

13. 13. The connector of claim 12, wherein the locking mechanism includes a clip slidably disposed within a lateral slot of the collar, and in the first state position, the clip is engaged with the portion of the stationary sleeve portion, and in the second state position, the movable clip is released from the portion of the stationary sleeve portion.

14. The connector of claim 13 , wherein the clip is biased toward the first state position by a biasing element.

15. The connector of claim 14 , wherein the clip includes at least one spring arm.

16. A connector according to any one of claims 1 to 15; an actuation system configured to operatively engage the locking mechanism to enable movement of the locking mechanism between the first configuration and the second configuration; Including, the system.

17. 17. The system of claim 16, wherein the actuation system is further configured to actuate the actuation mechanism to enable the hollow needle to pierce the pierceable seal and create communication through the pierceable seal.

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