Aseptic coupling assembly and method of aseptic coupling

Abstract

The sterile cryogenic coupling assembly includes a first connector, a second connector, and a gasket disposed on the first or second connector. The first and second connectors include first and second retaining features configured to couple the first and second connectors to one another and align openings in the first and second connectors. The gasket is formed to have little deformation after being cooled to at least -50°C and then heated to ambient temperature. The method of sterile connecting a cryogenic fluid storage container includes coupling the first connector to the second connector via the first and second retaining features of the connectors. The coupling compresses the gasket between the first and second connectors and aligns the opening in the first connector with the opening in the second connector.

Description

[Technical Field]

[0001] SUMMARY The present disclosure is directed to aseptic connections and coupling assemblies used in aseptic connections of cryogenic storage containers. [Background technology]

[0002] Chemical and / or biological processes may utilize or produce process materials that are stored in storage vessels, such as bags for storing chemical or biological fluids, bioprocessing bags, etc. Piping or other types of connections may be used to deliver process materials and / or reactants into the storage vessels. The process materials may need to be refrigerated or otherwise maintained at low temperatures within the storage vessels. Piping or other types of connections may then be used to remove the process materials from the storage vessels. Summary of the Invention

[0003] In one embodiment, the sterile cryogenic coupling assembly includes a first connector, a second connector, and a gasket disposed in one of the first and second connectors. The first and second connectors each include a fluid passageway having an opening. Each of the first and second connectors also includes a first and second retention feature disposed on either side of the opening of the fluid passageway of each of the first and second connectors. The first and second retention features have complementary shapes.

[0004] The first connector and the second connector are configured to be coupled to each other by engaging the first and second retention features of the first connector with the first and second retention features of the second connector, and the opening of the first fluid passage aligns with the opening of the second fluid passage. The gasket is formed to have little deformation after being cooled to at least -50°C and then heated to ambient temperature.

[0005] In one embodiment, a method for sterile connecting a cryogenic fluid storage container includes coupling a first connector to a second connector via a first retention feature and a second retention feature, wherein the first connector and the second connector each include a fluid passageway extending therethrough.

[0006] Coupling the first connector to the second connector includes engaging the first retention feature with the second retention feature, compressing a gasket between the first connector and the second connector, and aligning openings of the first and second fluid passages. Each of the first connector and the second connector includes one of the first retention features and one of the second retention features disposed on either side of an opening in the respective one of the first connector and the second connector. A gasket is disposed on one of the first connector and the second connector. The first gasket is formed to exhibit little deformation after being heated from a temperature of at least -50°C to ambient temperature. [Brief explanation of the drawings]

[0007] [Figure 1] FIG. 1 illustrates a front perspective view of one embodiment of a sterile cryogenic coupling assembly. [Figure 2] FIG. 2 is a rear perspective view, partially in section, of the sterile cryo-coupling assembly of FIG. 1, according to one embodiment. [Figure 3] FIG. 3 is a cross-sectional view of a sterile cryogenic coupling assembly as shown in FIG. 2, according to one embodiment. [Figure 4] FIG. 1 is a schematic diagram of one embodiment of a cryogenic storage vessel sterilely connected to a processing device using a prefabricated sterile cryogenic coupling assembly. [Figure 5] FIG. 10 is a front perspective view of a second embodiment of a sterile cryogenic coupling assembly. [Figure 6] FIG. 6 is a cross-sectional view of a sterile cryogenic coupling assembly as shown in FIG. 5, according to one embodiment. [Figure 7] FIG. 12 is a top perspective view of one embodiment of a connector for a sterile cryogenic coupling assembly. DETAILED DESCRIPTION OF THE INVENTION

[0008] Like numbers represent like features.

[0009] FIG. 1 is a perspective view of one embodiment of a sterile cryogenic coupling assembly 1. The coupling assembly 1 includes a first connector 10A and a second connector 10B configured to mate with each other to form a sealed fluid connection. The first connector 10A includes a first fluid passageway 12A extending therethrough. The second connector 10B includes a second fluid passageway 12B extending therethrough. The first fluid passageway 12A and the second fluid passageway 12B are generally indicated by dashed lines in FIG. 1. When the first connector 10A is mated to the second connector 10B, the first fluid passageway 12A and the second fluid passageway 12B are coupled to form a sealed fluid connection extending through the mated connectors 10A, 10B.

[0010] The first fluid passageway 12A includes an opening 14A disposed on an outer surface of the first connector 10A. For example, the opening 14A is disposed on a top surface 40A of the first connector 10A that faces the second connector 10B when mated. The first fluid passageway 12A also includes a second opening 16A at the opposite end of the first fluid passageway 12A. In one embodiment, the second opening 16A may be an inlet of the first connector 10A, and the first opening 14A may be an outlet of the first connector 10A.

[0011] The second fluid passage 12B includes an opening 14B disposed on an outer surface of the second connector 10B. For example, the opening 14B is disposed on a bottom surface 40B of the second connector 10B (shown in FIG. 3 ) that faces the first connector 10A when mated. The second fluid passage 12B also includes a second opening 16B at the opposite end of the second fluid passage 12B. For example, the first opening 14B may be an inlet for the second fluid passage 12B and the second connector 10B, and the second opening 16B may be an outlet for the second fluid passage 12B and the second connector 10B. In the mated connectors 10A, 10B, the opening 16A may be an inlet for the assembly 1, while the opening 16B may be an outlet for the assembly 1. The connection of the passages 12A, 12B within the mated connectors is described in more detail below.

[0012] The first connector 10A and the second connector 10B include retention features 30A, 30B, 32A, 32B, 34A, 34B, 36A, 36B (retention feature 36A is hidden in FIG. 1 ) used to couple the connectors 10A, 10B to one another. The retention features include first retention features 30A, 32A, 30B, 32B (one of the first retention features 30B is hidden in FIG. 1 ) and corresponding second retention features 34A, 36A, 34B, 36B. Each connector 10A, 10B has a first retention feature 30A, 30B and a second retention feature 34A, 34B disposed on either side of an opening 14A, 14B of a respective fluid passageway 12A, 12B of the connector 10A, 10B.

[0013] The first and second retention features 30A, 32A, 34A, and 36A of the first connector 10A engage with the first and second retention features 30B, 32B, 34B, and 36B of the second connector 10B to interconnect the first and second connectors 10A and 10B. In the first and second connectors 10A and 10B, the first retention features 30A / 30B, 32A / 32B, and the second retention features 34A / 34B, 36A / 36B have corresponding shapes. The first and second retention features 30A and 34A of the first connector 10A have corresponding shapes. For example, the first retention feature 30A has a shape that can engage with the second retention feature 34B. As shown in FIG. 1, the first connector 10A can have the same number and configuration of retention features as the second connector 10B. For example, the first connector 10A and the second connector 10B can have the same overall shape.

[0014] The connectors 10A, 10B are coupled to one another (e.g., as shown in FIG. 2) by first retention features 30A, 32A, 30B, 32B engaging with second retention features 34A, 36A, 34B, 36B. The first retention features 30A, 32A of the first connector 10A engage with corresponding second retention features 34B, 36B of the second connector 10B, and the first retention features 30B, 32B of the second connector 10B engage with corresponding second retention features 34A, 36A of the first connector 10A. For example, first retaining feature 30A engages with second retaining feature 34B, first retaining feature 32A engages with second retaining feature 36B, first retaining feature 30B engages with second retaining feature 34A, and first retaining feature 32B engages with second retaining feature 36A.

[0015] Connectors 10A, 10B are genderless connectors. Each of connectors 10A, 10B has at least one of first retention features 30A, 30B, 32A, 32B and at least one of second retention features 34A, 34B, 36A, 36B. In the illustrated embodiment, each of connectors 10A, 10B includes two of first retention features 30A / 30B, 32A / 32B and two of second retention features 34A / 34B, 36A / 36B. In one embodiment, first connector 10A and second connector 10B may each have one first retention feature 30A, 30B, 32A, 32B and one second retention feature 34A, 34B, 36A, 36B.

[0016] The first connector 10A and the second connector 10B each include a plurality of first retention features 30A, 32A and a plurality of second retention features 34A, 36A. The first connector 10A and the second connector 10B may each include two of the first retention features 30A / 30B, 32A / 32B and two of the second retention features 34A / 34B, 36A / 36B. In one embodiment, the first connector 10A may include one or more of the first retention features 30A, 32A and one or more of the second retention features 34A, 36A. In one embodiment, the second connector 10B includes at least one first retention feature 30B, 32B and at least one second retention feature 34B, 36B. Thus, each of the first connector 10A and the second connector 10B is a genderless connector such that it includes both male retention features (e.g., first retention features 30A / 30B, 32A / 32B) and female retention features (e.g., second retention features 34A / 34B, 36A / 36B).

[0017] The first retention features 30A, 30B, 32A, 32B may be any suitable structure for forming a mechanical connector with complementary second retention features 34A, 34B, 36A, 36B to form a snap fit, press fit, or the like. For example, each first retention feature 30A, 32A of the first connector 10A may be any suitable structure for forming a mechanical connector with a respective complementary retention feature 34B, 36B of the second connector 10B. The retention features may include, for example, slots, tabs, flanges, detents, hooks, or any other suitable structure for mechanical engagement with other structures. In the embodiment of FIG. 1, the first retention features 30A, 30B, 32A, 32B include retention protrusions.

[0018] The second retention features 34A, 34B, 36A, 36B may be any suitable structure for forming a mechanical connector with a complementary first retention feature 30A, 30B, 32A, 32B to form a snap fit, press fit, or the like. For example, each first retention feature 30A, 32A of the first connector 10A may be any suitable structure for forming a mechanical connector with a respective complementary retention feature 34B, 36B of the second connector 10B. Retention features may include, for example, slots, tabs, flanges, detents, hooks, or any other suitable structure for mechanical engagement with other structures. In the embodiment of FIG. 1, the second retention features 34A, 34B, 36A, 36B include retention slots. The retention slots may extend all the way through their respective connectors 10A, 10B.

[0019] The sterile cryogenic coupling assembly 1 can include a pair of removable films 20A, 20B that can seal the first and second fluid passageways 12A, 12B from the ambient environment prior to mating of the connectors 10A, 10B. The removable films 20A, 20B cover and seal the openings of the respective first and second fluid passageways 12A, 12B. For example, the first pull film 20A covers and seals the opening 14A of the first fluid passageway 12A, and the second pull film 20B covers and seals the opening 14B of the second fluid passageway 12B. The removable films 20A, 20B are configured to maintain the sterility of the fluid passageways 12A, 12B prior to mating of the connectors 10A, 10B. For example, each pull film 20A, 20B prevents airborne contaminants (e.g., dust, moisture, etc.) from entering the openings 14A, 14B of the respective fluid passages 12A, 12B of the connectors 12A, 12B used to fluidly connect the fluid passages 12A, 12B within the mated connectors 12A, 12B. Opposing openings of each fluid passage 12A, 12B (e.g., opening 16A of the first fluid passage 12A, opening 16B of the second fluid passage 12B) can be attached to a sealed connection (e.g., tubing, bioprocessing bags, etc.). The removable films 20A, 20B are removed once the connectors 10A and 10B are connected. For example, the removable films 20A, 20B are removed after being compressed between the mated connectors 10A, 10B.

[0020] In one embodiment, the removable films 20A, 20B are pull films configured to be removed by being pulled from the connectors 10A, 10B. Coupling compresses the pair of removable films 20A, 20B between the two connectors 10A, 10B. Assembly of the sterile cryogenic coupling assembly 1 may include pulling the compressed removable films 20A, 20B to remove the removable films 20A, 20B from the mated connectors 10A, 10B. In one embodiment, the compressed removable films 20A, 20B are configured to be simultaneously pulled and removed from between the mated connectors 10A, 10B. For example, connectors 10A, 10B compress removable films 20A, 20B along a first direction (e.g., compressed along direction D2 in FIG. 2), and the compressed removable films 20A, 20B are detached by being pulled in a second direction transverse to the first direction (e.g., pulled in direction D3 in FIG. 2).

[0021] The removable films 20A, 20B are attached to the connectors 10A, 10B in a manner that allows the removable films 20A, 20B, when compressed between the mated connectors 10A, 10B, to be simultaneously pulled from between and removed from the connectors 10A, 10B. The attachment of the removable films 20A, 20B allows a user to simultaneously grasp both removable films 20A, 20B so that the removable films 20A, 20B can be simultaneously pulled and removed. The configuration of the removable films 20A, 20B allows a user to manually grasp both removable films 10A, 10B and pull the films 10A, 10B in a direction transverse to the direction of compression (e.g., in the transverse direction D3). For example, the removable films 20A, 20B can each include an end 22A, 22B configured to be pulled away from their respective connectors 10A, 10B. The ends 22A, 22B are configured to be pulled away from their connectors 10A, 10B, thus forming the entire removable film 20A, 20B into a planar shape that can then be pulled in a single lateral direction to remove the compressed removable film 20A, 20B from between the two connectors 10A, 10B. Once removed, the removable film 20A, 20B will be completely detached from the connectors 10A, 10B.

[0022] This configuration of connectors 10A, 10B and removable films 20A, 20B allows the openings of first fluid passageway 12A and second fluid passageway 12B to remain sealed by the respective films 20A, 20B of connectors 10A, 10B until assembly 1 is assembled. This is advantageous for maintaining the sterility of fluid passageways 12A, 12B until they can form a sealed connection with one another within mated connectors 10A, 10B.

[0023] Figure 2 shows a perspective partial cross-sectional view of an assembled sterile cryogenic coupling assembly 1, according to one embodiment. A cross-sectional view of the second connector 10B is shown in Figure 2. Hidden features are shown in dashed lines in Figure 2.

[0024] As shown in the illustrated embodiment, the first retention feature can include a first retention protrusion and a second retention protrusion, and the second retention feature can include a first retention slot and a second retention slot. For example, first retention feature 32A is a first retention protrusion that engages with second retention feature 36B, which is a first retention slot, and first retention feature 32B is a second retention protrusion that engages with second retention feature 36A, which is a second retention slot. In one embodiment, other first retention features 30A, 30B, 32B can engage with their respective second retention features 34A, 34B, 36A in a manner similar to first retention feature 32A and second retention feature 36B shown in FIG. 2.

[0025] The retention protrusion 32A extends from a top surface 40A of the connector 10A. The top surface 40A of the connector 10A faces the opposing connector 10B when the connectors 10A, 10B are connected. In the embodiment shown in FIGS. 2 and 3, the tab 33 on the retention protrusion 32A forms a snap fit over the lip 37 of the retention slot 36B. The retention protrusion 32A is inserted into the retention slot 36B in a first direction D1, and then engaged with the retention slot 36B by moving the retention protrusion 32A in a second direction. Movement in the first direction D1 aligns the retention protrusion 32A with the lip 37 within the retention slot 36B (e.g., aligns the retention protrusion 32A with the lip 37 in the horizontal direction D1), and movement in the second direction D2 snaps the tab 33 onto and over the lip 37. For example, movement in a first direction D1 generally moves the connectors 10A, 10B perpendicular to one another, and movement in a second direction D2 moves the connectors 10A, 10B closer to one another.

[0026] The retention slot 36B may also include a bendable limiting member 41 that prevents the retention protrusion 32A from disengaging when inserted into the retention slot 36B. Inserting the retention protrusion 32A into the retention slot 36B in the first direction D1 causes the limiting member 41 to bend. For example, after the retention protrusion 32A is fully inserted into the retention slot 36B in the first direction D1, the limiting member 41 limits movement of the retention protrusion 32A along the first direction D1 (e.g., limits movement of the retention protrusion 32A in the opposite direction). The limiting member 41 is configured to allow the associated protrusion 32A to be moved in the second direction D2 to snap-fit ​​the tab 33 with the lip 37.

[0027] FIG. 3 shows a cross-sectional view of an assembled sterile cryogenic coupling assembly 1 according to one embodiment. The cross-sectional view of FIG. 3 is suggested by FIG. 2. FIG. 3 illustrates the connection of the first fluid passageway 12A of the first connector 10A and the second fluid passageway 12B of the second connector 10B in the assembled sterile cryogenic coupling assembly 1. As shown in FIG. 3, the first connector 10A can be configured to only directly contact the second connector 10B via its retention features when coupled together. For example, a gap 44 can be provided between the major opposing surfaces 40A, 40B of the connectors 10A, 10B (e.g., between the upper surface 40A of the first connector 10A and the lower surface 40B of the second connector 10B).

[0028] The first fluid passageway 12A includes an opening 14A disposed on an outer surface of the first connector 10A. For example, as shown in FIG. 3, the opening 14A is disposed on a top surface 40A of the first connector 10A that faces the second connector 10B when mated. The first fluid passageway 12A also includes a second opening 16A at an opposite end of the first fluid passageway 12A. For example, the first opening 14A may be configured to be an inlet of the first connector 10A, and the second opening 16A may be configured to be an outlet of the first connector 10A.

[0029] The second fluid passage 12B includes an opening 14B disposed on the outer surface of the second connector 10B. For example, as shown in FIG. 3 , the opening 14B is disposed on the underside 40B of the second connector 10B, which faces the first connector 10A when mated. The second fluid passage 12B also includes a second opening 16B at the opposite end of the second fluid passage 12B. For example, the first opening 14B can be an inlet for the second fluid passage 12B and the second connector 10B, and the second opening 16B can be an outlet for the second fluid passage 12B and the second connector 10B. In the mated connectors 10A and 10B, the opening 16A can be an inlet for the assembly 1, while the opening 16B can be an outlet for the assembly 1.

[0030] As shown in Figure 3, in the mated connectors 10A, 10B, the opening 14A of the first fluid passage 12A is aligned with the opening 14B of the second fluid passage 12B. The openings 14A, 14B are aligned by at least partially overlapping. As shown in Figure 3, the openings are aligned and overlap with respect to the second direction D2 (e.g., vertically).

[0031] The assembled sterile cryogenic coupling assembly 1 includes a first gasket 70 and a second gasket 75. The first gasket 70 is hidden in FIG. 1 because it is covered by a first pull film 20A. Prior to bonding, the pull film 20A (shown in FIG. 1) is disposed over the first gasket 70 and the first fluid passageway 12A to seal the first gasket 70 and the first fluid passageway 12A. For example, the pull film 20A covers and forms a seal over the opening 14A and the first gasket 70 disposed over the opening 14A of the first fluid passageway 12A. In a similar manner, the pull film 20B (shown in FIG. 1) is disposed over the second gasket 75 and the second fluid passageway 12B to seal the second gasket 75 and the second fluid passageway 12B. As described above, mating of connectors 10A, 10B compresses removable films 20A, 20B between connectors 10A, 10B. More specifically, removable films 20A, 20B are compressed between two gaskets 70, 75. Materiel coupling of connectors 10A, 10B pinches removable films 20A, 20B between two gaskets 70, 75. For example, removable films 20A, 20B are pinched between the top of first gasket 70 and the bottom of second gasket 75.

[0032] As shown in FIG. 3 , a first gasket 70 is disposed in a first connector 10A, and a second gasket 75 is disposed in a second connector 10B. The first gasket 70 is disposed in a first fluid passage 12A of the first connector 10A. The second gasket 75 is disposed in a second fluid passage 12B of the second connector 10B. More specifically, the first gasket 70 is disposed at an end of the first fluid passage 12A and extends outward through an opening 14A of the first fluid passage 12A. The second gasket 75 is disposed at an end of the second fluid passage 12B and extends outward through an opening 14B of the second fluid passage 12B. 3, the first gasket 70 and the second gasket 75 are disposed between the opening 14A of the first fluid passage 12A and the opening 14B of the second fluid passage 12B, respectively. More specifically, the ends of each gasket 70, 75 are disposed between the opening 14A of the first fluid passage 12A and the opening 14B of the second fluid passage 12B.

[0033] In the illustrated embodiment, the gaskets 70, 75 have a cylindrical shape. In other embodiments, the gaskets 70, 75 may have different shapes. For example, the first gasket 70 in one embodiment may have an O-ring shape.

[0034] Mating the first connector 10A and the second connector 10B involves moving the connectors 10A, 10B closer to one another (e.g., moving the first connector 10A in direction D2 in FIG. 3 , moving the second connector 10B in direction D3 in FIG. 3 , etc.) to engage their corresponding retention features. Mating the first connector 10A and the second connector 10B compresses the first gasket 70 and the second gasket 75 between the first connector 10A and the second connector 10B. Mating the connectors 10A, 10B presses the first gasket 70 against the second gasket 75, compressing the gaskets 70, 75. The first gasket 70 is compressed between the first connector 10A and the second gasket 75. The second gasket 75 is compressed between the second connector 10B and the first gasket 70.

[0035] As shown in FIG. 3 , the compressed gaskets 70, 75 form a channel 42 that fluidly connects the first fluid passage 12A to the second fluid passage 12B in a sealed manner. Compression of the gaskets 70, 75 against each other and against the connectors 10A, 10B results in a sealed connection between the first and second fluid passages 12A, 12B. Mating the connectors 10A, 10B as shown in FIG. 3 connects the first fluid passage 12A with the second fluid passage 12B to form a sealed fluid connection extending through the mated connectors 10A, 10B. In one embodiment, fluid can then flow through the sealed fluid connection formed in the assembled coupler assembly 1, as indicated by the dashed arrows in FIG. 3 . For example, the opening 16A of the first fluid passage 12A serves as an inlet for the sealed fluid connection, while the opening 16B of the second fluid passage 12B serves as an outlet for the sealed fluid connection.

[0036] 4 is a schematic diagram of a bioprocessing bag 90 sterilely connected to a processing device 92 using a prefabricated sterile cryogenic coupling assembly 1. For example, the processing equipment 92 can include equipment for supplying process materials or reactants that form the process materials to fill the bag 90 and / or equipment for utilizing the process materials stored in the bioprocessing bag 90. The bioprocessing bag 90 is an example of a cryogenic fluid storage container. The inlet (e.g., opening 16A of the first connector 10A) of the assembly 1 is fluidly connected to the bioprocessing bag 90, and the outlet 2 (e.g., opening 16B of the second connector 10B) is fluidly connected to the processing equipment 92. For example, the inlet of the assembly 1 is configured to be inserted into piping 96 that connects to the bioprocessing bag 90, and the outlet of the assembly 1 is configured to be inserted into piping 98 that connects to the processing equipment 92. In another embodiment, the inlet of the assembly 1 (e.g., opening 16A of the first connector 10A) may be configured to be attached (e.g., molded, fused, etc.) directly to the bioprocessing bag 90.

[0037] The filled bioprocessing bag 90 is configured to be stored at freezing temperatures (e.g., temperatures below 0°C). For example, the bag holder 94 can be configured to hold the bioprocessing bag 90 in a refrigeration system (e.g., a blast chiller, a low-temperature freezer, etc.). In one embodiment, the bioprocessing bag 90 is configured to be stored at temperatures below -50°C. In one embodiment, the bioprocessing bag 90 is configured to be stored at cryogenic temperatures below -150°C. In one embodiment, the bioprocessing bag 90 is configured to be stored at cryogenic temperatures below -190°C. As shown in FIG. 4 , the first connector 10A and the second connector 10B are configured to be disposable within the bag holder 94 along with the bag 90. For example, the first connector 10A is configured to be disposed within the bag holder 94 along with the bag 90 during freezing.

[0038] The assembly 1 is configured to form a sealed connection after being frozen with the bioprocessing bag 90 and then heated back to ambient temperature. For example, the assembly 1 is configured to provide a sealed connection after being frozen to the storage temperature of the bag 90 and then heated (e.g., by applying heat to the bioprocessing bag 90 and exposing the bioprocessing bag 90 to ambient temperature, etc.). The first connector 10A, after being frozen with the bioprocessing bag 90 and then heated back above freezing (e.g., to ambient temperature), is connected with the second connector 10B to form a sealed connection. In one embodiment, the second connector 10B does not freeze with the first connector 10A and the bag 90. For example, the ambient temperature is at or about 20°C. The first connector 10A, the second connector 10B, and the gaskets 70, 75 are formed to have little deformation after being cooled to at least -50°C and then heated to ambient temperature. Substantial deformation includes, for example, visible cracking in the material, shrinkage or expansion of the material relative to its original shape at ambient temperatures that may interfere with the connection between the first connector 10A and the second connector 10B or adversely affect the seal of the connection. The gaskets 70, 75 are each formed to exhibit little deformation by being made of a material that remains elastic even when cooled to temperatures such as liquid nitrogen. In embodiments, suitable gaskets that exhibit little deformation at low temperatures can be determined by tests including, by way of non-limiting example, low-temperature elastic recovery testing and / or brittleness testing. Low-temperature elastic recovery testing can be performed according to ASTM D1329, ISO 2921, or any other suitable test method to determine suitable elastic recovery characteristics of a material at temperatures at which the gasket may be used. Brittleness testing can be performed according to ASTM D2137, ISO 28702, or any other suitable test method to determine resistance to cracking at temperatures at which the gasket may be used.

[0039] The first connector 10A and its attached pull film 20A, and the second connector 10B and its attached second pull film 20B, are each formed to exhibit little deformation after returning to ambient temperature from a temperature below -50°C. The connectors 10A, 10B and the pull film 20A are each formed of a polymer material that exhibits no visible cracking and maintains the seal of the first opening 14A by the first pull film 20A and the second opening 14B by the second pull film 20B when cooled to a certain temperature after returning to ambient temperature from a temperature below -50°C. The connectors 10A, 10B may be made of the same or different types of polymer materials. The pull films 20A, 20B may be made of the same or different types of polymer materials. In one embodiment, the first connector 10A and its attached pull film 20A, and the second connector 10B and its attached second pull film 20B are each formed to exhibit little deformation after returning to ambient temperature from a temperature of -150°C or below. In such an embodiment, the connectors 10A, 10B and the pull films 20A, 20B are each formed of a polymer material that does not exhibit any visible cracking and maintains the seal of the first opening 14A by the first pull film 20A and the second opening 14B by the second pull film 20B after returning to ambient temperature from a temperature of -150°C or below. In one embodiment, the connectors 10A, 10B and the pull films 20A, 20B are formed of a polymer material that exhibits little deformation after returning to ambient temperature from a temperature of -190°C or below. In such an embodiment, connectors 10A, 10B and pull films 20A, 20B are each formed of a polymeric material that does not exhibit any visible cracking and maintains the seal of first opening 14A by first pull film 20A and second opening 14B by second pull film 20B after returning to ambient temperature from a temperature of −190° C. or below. For example, this may allow assembly 1 to be used at cryogenic storage temperatures.

[0040] The polymeric material of connectors 10A, 10B is typically a polymer that is generally non-reactive (e.g., non-reactive to air, non-reactive to process materials or reactants used in bioprocessing bags). For example, in one embodiment, connectors 10A, 10B each comprise a fluoropolymer. The polymeric material of connectors 10A, 10B has sufficient stiffness at ambient temperatures to compress gaskets 70, 75 between connectors 10A, 10B to form a sealed connection between fluid pathways 12A, 12B and to prevent accidental disengagement of engaged first and second retention features.

[0041] The polymeric material of pull films 20A, 20B is typically a polymer that is generally non-reactive (e.g., non-reactive to air, non-reactive to process materials or reactants used in bioprocessing bags). The polymeric material of gaskets 70, 75 at ambient temperatures has compressibility that allows gaskets 70, 75, when compressed between connectors 10A, 10B, to form a sealed connection between fluid pathways 12A, 12B. For example, in one embodiment, gaskets 70, 75 include one or more of silicone and ethylene vinyl acetate (EVA).

[0042] Figure 5 is a perspective view of another embodiment of a sterile cryogenic coupling assembly 101. The coupling assembly 101 includes a first connector 110A and a second connector 110B that mate to form a sealed fluid connection. The first connector 110A includes a first fluid passageway 112A extending therethrough. The second connector 110B includes a second fluid passageway 112B extending therethrough. The first fluid passageway 112A and the second fluid passageway 112B are generally indicated by dashed lines in Figure 5. The connectors 110A, 110B may be made of materials similar to those described above for the connectors 10A, 10B of the assembly 1 of Figures 1-3.

[0043] Coupling assembly 101 includes a pair of pull films (not shown), omitted for purposes of illustration. A first pull film covers and seals first fluid passageway 112A, and a second pull film covers and seals second fluid passageway 112B. The pull films can be attached to each connector 110A, 110B and cover the respective fluid passageways 112A, 112B of connectors 110A, 110B in a manner similar to pull films 20A, 20B described for assembly 1 of FIG. 1.

[0044] Connectors 110A, 110B include first retention features 130A, 130B and second retention features 134A, 134B. Each of connectors 110A, 110B has at least one of the first retention features 134A, 134B and at least one of the second retention features 134A, 134B. Connectors 110A, 110B are coupled to one another (e.g., as shown in FIG. 6 ) by engaging first retention features 130A, 130B with second retention features 134A, 134B, as similarly described for connectors 10A, 10B of FIGS. 1-3 . A first retention feature 130A of the first connector 110A engages a corresponding second retention feature 134B of the second connector 110B, and a first retention feature 130B of the second connector 110B engages a corresponding second retention feature 134A of the first connector 110A. For example, the first retention feature 130A engages with the second retention feature 134B, and the first retention feature 130B engages with the second retention feature 134A.

[0045] The first retention features 134A, 134B may have a structure similar to that described above with respect to the first retention features of the connectors 10A, 10B of FIGS. 1-3. The second retention features 134A, 134B may have a structure similar to that described above with respect to the second retention features of the connectors 10A, 10B of FIGS. 1-3. The first retention features 134A, 134B engage with corresponding second retention features 134A, 134B to couple the connectors 110A, 110B together. For example, the first retention feature 130A may include a retention protrusion having a tab 133, and the second retention feature 134B may be a retention slot. As shown in the illustrated embodiment, the first retention feature 130A on the first connector 110A may include a pair of retention protrusions, each including a tab 133. In one embodiment, the first retention feature 130A may include a single retention protrusion.

[0046] The first connector 110A and the second connector 110B are moved toward each other in a first direction D4 to engage corresponding retention features 130A, 130B, 134A, 134B of the first connector 110A and the second connector 110B and couple the connectors (e.g., moving the first connector 110A in direction D4 in FIG. 5 and moving the second connector 110B in the opposite direction to direction D4 in FIG. 5). In contrast to assembly 1 of FIGS. 1-3, movement of connectors 110A, 110B along one direction D4 couples connectors 110A, 110B together.

[0047] The first fluid passageway 112A includes an opening 114A disposed on an outer surface of the first connector 110A. For example, as shown in FIG. 5 , the opening 114A is disposed on a top surface of the first connector 110A that faces the second connector 110B when mated. The first fluid passageway 112A also includes a second opening 116A at an opposite end of the first fluid passageway 112A. For example, the first opening 114A may be configured to be an inlet of the first connector 110A, and the second opening 116A may be configured to be an outlet of the first connector 110A.

[0048] The second fluid passage 112B includes an opening 114B disposed on the outer surface of the second connector 110B. For example, as shown in FIG. 3 , the opening 114B is disposed on the underside of the second connector 110B that faces the first connector 110A when mated. The second fluid passage 112B also includes a second opening 116B at the opposite end of the second fluid passage 112B. For example, the first opening 114B may be an inlet for the second fluid passage 112B and the second connector 110B, and the second opening 116B may be an outlet for the second fluid passage 112B and the second connector 110B. In the mated connectors 110A, 110B, the opening 116A may be an inlet for the assembly 101, while the opening 116B may be an outlet for the assembly 101.

[0049] A first gasket 170 is disposed in the opening 116A of the first fluid passage 112A, and a second gasket 175 is disposed in the opening 116B of the second fluid passage 112B. The gaskets 170, 175 can have a similar configuration in the first and second connectors 110A, 110B as described above for the gaskets 70, 75 in the first and second connectors 10A, 10B of Figures 1-3. The gaskets 170, 175 can be formed of the same materials as described above for the gaskets 70, 75 in the assembly 1 of Figures 1-3.

[0050] FIG. 6 is a cross-sectional view of the assembled coupling assembly 101. The cross-sectional view is a horizontal plane along the line shown in FIG. 5. Mating the first connector 110A and the second connector 110B involves moving the connectors 110A, 110B closer to each other (e.g., moving the first connector 110A in direction D4 in FIG. 5 and moving the second connector 110B in the opposite downward direction in FIG. 5) to engage corresponding retention features of the connectors 110A, 110B. Mating the first connector 110A and the second connector 110B compresses the first gasket 170 and the second gasket 175 between the first connector 110A and the second connector 110B. Mating the connectors 110A, 110B presses the first gasket 170 against the second gasket 175, compressing the gaskets 170, 175. The first gasket 170 is compressed between the first connector 110A and the second gasket 175. The second gasket 175 is compressed between the second connector 110B and the first gasket 170.

[0051] As shown in FIG. 6 , the compressed gaskets 170, 175 form a channel 142 that fluidly connects the first fluid passage 112A to the second fluid passage 112B in a sealed manner. Compression of the gaskets 170, 175 against each other and against the connectors 110A, 110B results in a sealed connection between the first and second fluid passages 112A, 112B. Mating the connectors 110A, 110B as shown in FIG. 6 connects the first fluid passage 112A with the second fluid passage 112B to form a sealed fluid connection extending through the mated connectors 110A, 110B. In one embodiment, fluid can then flow through the sealed fluid connection formed in the assembled coupler assembly 101, as indicated by the dashed arrows in FIG. 6 . For example, opening 116A of first fluid passageway 112A serves as an inlet for the sealed fluid connection, while opening 116B of second fluid passageway 112B serves as an outlet for the sealed fluid connection.

[0052] As shown in the embodiment of FIG. 6 , a tab 133 on the retention protrusion of the first retention feature 130A forms a snap fit over a lip 137 of the retention slot of the second retention feature 134B. The retention slot can also include multiple lips 137, 139 for engaging the retention protrusions. The first lip 139 is at a first depth of the retention slot, and the second lip 137 is at a second depth of the retention slot. For example, the first lip 139 may be used to initially mate the first connector 110A to the second connector 110B, and the second lip 137 may be used to compress the gaskets 70, 75 to a desired compression for the assembled assembly 101. The two retention protrusions may be configured to be pressed together to fit in and past the lips 133. For example, the two retention protrusions are configured to be pinched together to fit in and past the lips 133.

[0053] Figure 7 is a top perspective view of a connector 210 for a sterile cryogenic coupling assembly. The sterile cryogenic coupling assembly includes two of the connectors 230 that are configured to mate with each other to form a sealed fluid connection in a manner generally similar to the connectors 10A, 10B of the assembly 1 of Figures 1-3 and the connector of the assembly of Figures 5-6.

[0054] Connector 210 generally has features similar to first connector 110A of FIG. 4 , except for the configuration of first retention feature 230 and second retention feature 234. For example, connector 210 includes a fluid passageway 212 (shown generally in dashed lines in FIG. 7 ) that extends through first connector 210 and includes a first opening 214 and a second opening 216 disposed at opposite ends of fluid passageway 212. Gasket 270 is disposed in connector 210. For example, gasket 270 can have a similar configuration in connector 210 as described above for gasket 70 of assembly 1 and first connector 10A of FIGS. 1-3 .

[0055] Connector 210 includes a first retention feature 230 and a second retention feature 234. First retention feature 230 includes two retention protrusions, and second retention feature 234 includes a retention slot. The retention slot includes a pair of lips 233, 235 disposed on opposite sides of the retention slot. The two retention protrusions are configured to bend closer to each other to fit past the lips 233, 235 in the opposing connector. For example, the retention protrusions can be pinched together to fit past the lips 233, 235 in the retention slot.

[0056] Aspects: Any of the embodiments 1 to 15 may be combined with any of the embodiments 16 to 18.

[0057] Aspect 1. A first connector including a first fluid passage extending therethrough, the first fluid passage including an opening; and a second connector including a second fluid passage extending therethrough, the second fluid passage including an opening; the first connector and the second connector including first and second retention features, respectively, disposed on either side of the opening in one of the first and second connectors, the first and second retention features having complementary shapes. a first gasket disposed on one of the first connector and the second connector, the first connector and the second connector being configured to be coupled to one another by engaging the first and second retaining features of the first connector with the first and second retaining features of the second connector, the opening of the first fluid passage being aligned with the opening of the second fluid passage, and the first gasket being formed to have little deformation after being cooled to at least -50°C and then heated to ambient temperature.

[0058] Aspect 2. A sterile low-temperature coupling assembly as described in Aspect 1, wherein the coupling of the first connector and the second connector compresses the first gasket between the first connector and the second connector, and the first gasket is disposed between the opening of the first fluid passage and the opening of the second fluid passage.

[0059] Aspect 3. A sterile cryogenic coupling assembly according to aspect 1 or 2, further comprising a first removable film disposed over the opening of the first fluid passageway to seal the opening of the first fluid passageway, and a second removable film disposed over the opening of the second fluid passageway to seal the opening of the second fluid passageway.

[0060] Aspect 4. A sterile low-temperature coupling assembly as described in Aspect 3, wherein in the coupling of the first connector and the second connector, the first removable film and the second removable film are compressed between the first connector and the second connector, and the first removable film and the second removable film are configured to be removable while compressed between the first connector and the second connector.

[0061] Aspect 5. A sterile low-temperature coupling assembly described in any one of aspects 1 to 4, further comprising a second gasket, the second gasket being disposed in the second connector and the first gasket being disposed in the first connector, and the coupling of the first connector and the second connector pressing the first gasket against the second gasket and compressing both the first gasket and the second gasket between the first connector and the second connector.

[0062] Aspect 6. A sterile cryogenic coupling assembly described in any one of Aspects 1 to 5, wherein the first retention feature includes a first retention protrusion and a second retention protrusion, the second retention feature includes a first retention slot and a second retention slot, the first retention protrusion is inserted into the first retention slot, and the second retention protrusion is inserted into the second retention slot to couple the first connector and the second connector.

[0063] Aspect 7. A sterile cryogenic coupling assembly as described in Aspect 6, wherein the first connector includes the first retention protrusion and the first retention slot, and the second connector includes the second retention protrusion and the second retention slot.

[0064] Aspect 8. The sterile cryogenic coupling assembly of aspect 6 or 7, wherein the first retention protrusion and the second retention protrusion have the same shape.

[0065] Aspect 9. A sterile low-temperature coupling assembly described in any one of aspects 1 to 8, wherein the first connector is formed of a polymeric material that has little deformation after being cooled to at least -50°C and then heated back to the ambient temperature.

[0066] Aspect 10. A sterile low-temperature coupling assembly described in any one of aspects 1 to 9, wherein the first connector is formed of a polymeric material that does not exhibit cracking and maintains a seal after being cooled to at least -190°C and then heated back to the ambient temperature.

[0067] Aspect 11. A sterile low-temperature coupling assembly described in any one of aspects 1 to 10, wherein the first connector, the second connector, and the first gasket are configured to provide a sealed fluid connection after being cooled to at least -50°C and then heated back to the ambient temperature.

[0068] Aspect 12. A sterile low-temperature coupling assembly described in any one of Aspects 1 to 1, wherein the first connector comprises a fluoropolymer.

[0069] Aspect 13. A sterile cryogenic coupling assembly described in any one of aspects 1 to 12, wherein the first gasket comprises one or more of silicone and ethylene vinyl acetate (EVA).

[0070] Aspect 14. The aseptic low-temperature coupling assembly of any one of Aspects 1 to 13, wherein the gasket exhibits no abnormalities when tested at -190°C according to ISO Standard 28702, Method B.

[0071] Aspect 15. A sterile cryogenic coupling assembly described in any one of aspects 1 to 15, wherein the first connector and the second connector are configured to be disposably coupled together with a bag within a bag holder, and the first connector is configured to be fluidly connected to the bag.

[0072] Aspect 16. A method of sterile connecting a cryogenic fluid storage container, the method comprising: coupling a first connector to a second connector via a first retention feature and a second retention feature, a first fluid passageway extending through the first connector and a second fluid passageway extending through the second connector, the first fluid passageway and the second fluid passageway each including an opening; coupling the first connector to the second connector by engaging the first retention feature with the second retention feature, the first connector and the second connector engaging the opening in the respective one of the first connector and the second connector. a first connector including one of the first retaining features and one of the second retaining features disposed on opposite sides of a portion of the first connector, the first retaining feature engaging the first retaining feature with the second retaining feature; compressing a first gasket between the first connector and the second connector, the first gasket being disposed on one of the first connector and the second connector; and aligning the opening of the first fluid passage with the opening of the second fluid passage, the first gasket being formed to have little deformation after being heated from a temperature of at least -50°C to ambient temperature.

[0073] Aspect 17. The method of aspect 16, further comprising compressing each of a first pull film disposed over the outlet of the first fluid passage and a second pull film disposed over the opening of the second fluid passage between the first connector and the second connector, and simultaneously removing the first pull film and the second pull film compressed between the first connector and the second connector by simultaneously pulling the first pull film and the second pull film in the lateral direction.

[0074] Aspect 18. The method of Aspect 17 further includes compressing a second gasket between the first connector and the second connector, wherein the first gasket is disposed in the first connector and the second gasket is disposed in the second connector, and before removal, the first pull film is disposed over the first passage and the first gasket to seal the first passage and the first gasket.

[0075] The examples disclosed in this application are to be considered in all respects as illustrative and not restrictive. The scope of the invention is indicated by the appended claims, rather than the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are intended to be embraced therein.

Claims

1. a first connector including a first fluid passageway extending therethrough, the first fluid passageway including an opening; a second connector including a second fluid passageway extending therethrough, the second fluid passageway including an opening, the first connector and the second connector including first and second retention features, respectively, disposed on opposite sides of the opening in one of the first and second connectors, the first and second retention features having complementary shapes; a first gasket disposed on one of the first connector and the second connector; Equipped with the first connector and the second connector are configured to be coupled to one another by engaging the first and second retention features of the first connector with the first and second retention features of the second connector, and the opening of the first fluid passage is aligned with the opening of the second fluid passage; the first gasket is formed to have little deformation after being cooled to at least −50° C. and then heated to ambient temperature; A sterile cryogenic coupling assembly, wherein the first connector and the second connector are configured to disposably mate with a bag in a bag holder, and the first connector is configured to be fluidly connected to the bag.

2. a first removable film disposed over the opening of the first fluid passage to seal the opening of the first fluid passage; a second removable film disposed over the opening of the second fluid passageway to seal the opening of the second fluid passageway; and 10. The sterile cryogenic coupling assembly of claim 1, further comprising:

3. 2. The sterile cryogenic coupling assembly of claim 1, wherein the first retention feature includes a first retention protrusion and a second retention protrusion, the second retention feature includes a first retention slot and a second retention slot, the first retention protrusion being inserted into the first retention slot and the second retention protrusion being inserted into the second retention slot to couple the first connector and the second connector.

4. 2. The sterile cryogenic coupling assembly of claim 1, wherein the ambient temperature is at least 20°C.

5. 1. A method for sterile connecting a cryogenic fluid storage container, comprising: a first fluid passage extending through the first connector and a second fluid passage extending through the second connector, the first fluid passage and the second fluid passage each including an opening; and coupling the first connector to the second connector via a first retention feature and a second retention feature, the first fluid passage extending through the first connector and the second fluid passage each including an opening; engaging the first retention feature with the second retention feature, wherein the first connector and the second connector each include one of the first retention features and one of the second retention features disposed on either side of the opening in one of the first connector and the second connector; compressing a first gasket between the first connector and the second connector, the first gasket being disposed on one of the first connector and the second connector; aligning the opening of the first fluid passage with the opening of the second fluid passage; the first gasket is configured to undergo little deformation after being heated from a temperature of at least −50° C. to ambient temperature; The method, wherein the first connector and the second connector are configured to disposably mate in a bag holder together with a bag, and the first connector is configured to be fluidly connected to the bag.

6. The method of claim 5, wherein the ambient temperature is at least 20°C.

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