Overmolded connector and method for manufacturing the same

Abstract

This disclosure provides a fluid coupling assembly for transferring fluids from chemical and / or biological processes, etc., through multiple different pipes, fittings, and storage containers. [Solution] A fluid connection assembly comprising a plurality of tubes having a first open end and a second open end opposite the first open end, and a plurality of connectors. Each connector comprises at least two connector portions, in which each of the at least two connector portions has a first end extending from the center of the connector and connected to the center of the connector, and a second end connected to the second open end of one of the plurality of tubes. The connector portions are formed continuously with the centers of the tubes and connectors, and the connector portions are fluidly connected to one another.

Description

Technical Field

[0001] This disclosure claims the benefit of U.S. Provisional Patent Application No. 63 / 274,357, filed Nov. 1, 2021. The priority document is incorporated herein by reference.

[0002] This disclosure is directed to a fluid connection assembly for transferring fluids from chemical processes and / or biological processes, etc. through a plurality of different pipes, joints, and storage containers.

Background Art

[0003] Chemical processes and / or biological processes may utilize or produce process materials stored in storage containers such as bags, bioprocess bags, etc. that contain pharmaceutical fluids or biological fluids. Pipes or other types of joints and connectors may be utilized to supply process materials and / or reactants into the storage containers. The process materials may need to be frozen or otherwise kept at low temperatures within the storage containers. Then, pipes or other types of joints and connectors may be utilized to remove and / or transfer the process materials from the storage containers.

Summary of the Invention

[0004] Some embodiments of the fluid connection assembly include a plurality of tubes and a plurality of connectors, each of which includes at least two connector portions. Each connector portion has a first end extending from the center of the connector and connected to the center of the connector, and a second end connected to the tube. The connector portions are formed continuously with the center of the tube and the connector so as to be fluidly connected to one another. Each connector portion is tapered into a cone shape, and the outer diameter of the first end at the center of the connector is greater than the outer diameter of the second end of the connector portion so as to be flexible. In some embodiments, the connector portion includes a strain relief portion provided along the outer surface of the connector portion. In some embodiments, the strain relief portion includes a plurality of rib sections provided in parallel along the longitudinal direction of the connector portion, with the rib sections provided closer to the center of the connector having a larger outer diameter than the rib sections provided at the second end of the connector portion. In other embodiments, the strain relief portion includes a helical rib section provided along the longitudinal direction of the connector portion, wherein the first end of the helical rib section, located closer to the center of the connector, has a larger outer diameter than the second end of the helical rib section located at the second end of the connector portion. In yet another embodiment, the strain relief portion includes a segmented core portion removed from the outer surface of the connector portion. It is recognized that such a structure allows the connector and the connector portion to be flexible.

[0005] Other embodiments may include a method for manufacturing a fluid connection assembly that includes a connector having a connector portion formed continuously with a tube. In some embodiments, the continuous formation of the connector portion and the tube is achieved by overmolding the connector portion and the tube so that the connector portion is fluidly connected to the center of the connector and the tube.

[0006] Details of one or more embodiments of this disclosure will be made apparent in the accompanying drawings and description and in the claims.

[0007] Refer to the accompanying drawings, which form part of this disclosure, and which illustrate embodiments that can put into practice the systems and methods described herein. [Brief explanation of the drawing]

[0008] [Figure 1] This is a schematic diagram of a fluid connection assembly according to one embodiment. [Figure 2A] Figure 1 is a front view of the connector of the fluid connection assembly. [Figure 2B] Figure 1 is a cross-sectional view of the connector of the fluid connection assembly. [Figure 2C] Figure 1 is a perspective view of the connector of the fluid connection assembly. [Figure 2D] Figure 1 is a perspective view of the connector of the fluid connection assembly. [Figure 3A-3B] Front view and cross-sectional view of another embodiment of the distortion relief portion of the connector. [Figure 4A-4B] Front view and cross-sectional view of another embodiment of the distortion relief portion of the connector. [Figure 4C-4D] Front view and cross-sectional view of another embodiment of the distortion relief portion of the connector. [Figure 4E-4F] Front view and cross-sectional view of another embodiment of the distortion relief portion of the connector. [Figure 4G-4H] Front view and cross-sectional view of another embodiment of the distortion relief portion of the connector. [Figure 5A-5B] Front view and cross-sectional view of another embodiment of the connector shape. [Figure 5C-5D] Front view and cross-sectional view of another embodiment of the connector shape. [Figure 5E] This is a front view of another embodiment of the connector shape. [Figure 5F] This is a perspective view of a spine assembly and connector of at least one embodiment. [Figure 6] This is a flowchart illustrating a method for manufacturing a fluid connection assembly with a connector. [Modes for carrying out the invention]

[0009] Similar numbers represent similar characteristics.

[0010] This disclosure generally relates to fluid connection assemblies for transferring fluids. More specifically, this disclosure relates to fluid connection assemblies comprising a plurality of tubes and a plurality of connectors for transferring fluids from storage containers, e.g., filling and unfilling. Fluids related to chemical and / or biological processes are discussed below, but such discussion is not intended to limit the scope of the invention and is recognized as being provided as embodiments of the invention.

[0011] Some chemical and / or biological processes utilize or produce process materials that are stored in storage containers, such as bags containing pharmaceutical or biological fluids. Pharmaceutical or biological fluids may also require to be frozen or otherwise maintained at low temperatures within the storage container. Fluids are recognized to contain, but are not limited to, substances that flow or deform when shear stress is applied. Fluids may include, for example, liquids.

[0012] Fluid connection assemblies, including piping and / or other types of fittings and connectors, may be used to supply pharmaceutical or biological fluids into, for example, a plurality of storage containers, such as a bag assembly, and / or to withdraw pharmaceutical or biological fluids from, for example, a plurality of storage containers, such as a bag assembly. For example, connectors are used to connect pipes and bag assemblies to form a spine-like assembly for the transfer of pharmaceutical or biological fluids into and from a plurality of storage containers.

[0013] However, it has been observed that conventional connectors, including hose barbs and mechanical connectors for connecting rigid connectors to piping, such as 3-clamp connection systems, use rigid connectors that cannot be bent. Such conventional connectors not only internally create gaps between the piping and the rigid connector that can form pockets that accumulate fluid and lead to contamination and damage of cells in the fluid, but also cause interruptions in the flow path when the piping connected to the rigid connector is bent, for example, by creating kinks in the piping and / or creating an oval internal shape that affects the flow path. To overcome the limitations in the flow path, the process pressure was typically increased. Such increases in pressure not only resulted in different supply pressures being provided to the bag assemblies, leading to overfilling and underfilling of the bag assemblies, but the increased pressure also led to failures of the piping, connectors, mechanical connectors, and / or bag assemblies, resulting in leakage of pharmaceutical or biological fluids. Thus, conventional connectors not only created limitations in the flow path, but also increased the pressure and mechanical connectors, leading to potential failure points, such as fluid leakage due to pressure differences in vertebral assemblies.

[0014] It has also been observed that, when conventional rigid connectors and spine assemblies using mechanical connectors are stored at extremely low temperatures below -190°C, the ultra-low temperatures cause leakage in the spine assemblies, thereby allowing, for example, the intrusion of cryogenic fluids such as liquid nitrogen or similar into the storage container, or leakage of pharmaceutical or biological fluids. While we do not wish to be constrained by theory, it is understood that when spine assemblies are introduced into cryogenic systems, spine assemblies, piping, and / or rigid connectors, which may be made of different materials having different thicknesses and different coefficients of thermal expansion (and contraction), will contract at different rates and / or have different thermal properties, such as rigidity / flexibility, particularly at ultra-cold cryogenic temperatures. Therefore, when spine assemblies, tubes, and connectors are introduced into cryogenic systems, the differences in contraction rates and / or thermal properties can cause the connections between spine assemblies, such as tubes, mechanical connectors, and joints between connectors, to fail, resulting in the intrusion of nitrogen in liquid or gaseous form into storage containers, or leakage of pharmaceutical or biological fluids.

[0015] Referring to Figures 1 to 2C, one embodiment of a fluid connection assembly 1 that overcomes the shortcomings of the prior art is shown. The fluid connection assembly 1 includes a plurality of tubes 4 and a plurality of connectors 6 that together form a spine-like assembly, which is used to connect a bag assembly 8 for the transfer of pharmaceutical or biological fluids to and from a processing facility 10. The plurality of tubes include tubes having an inner diameter between 1 / 8 inch and 1 inch and an outer diameter between 1 / 4 inch and 1 1 / 4 inches or a combination thereof. The bag assembly may be a cryogenic fluid storage container or a similar storage container for storing pharmaceutical or biological fluids.

[0016] The fluid connection assembly 1 is a pressurization system for the transfer of pharmaceutical fluids or biological fluids. The fluid connection assembly 1 can be used to evenly distribute the pharmaceutical fluid or biological fluid to the bag assemblies. In other embodiments, the pharmaceutical fluid or biological fluid can be distributed to the bag assemblies in different amounts according to the user's requirements, such as bag assemblies of different sizes. In some embodiments, it is recognized that instead of the fluid connection assembly being used in a pressurization system, a negative pressure can be used to transfer the pharmaceutical fluid or biological fluid from the bag assemblies.

[0017] Figures 2A - 2D show one embodiment of one of the plurality of connectors. As seen in Figure 2A, the connector 6 includes a plurality of connector portions 210 extending from the center 215 of the connector 6. The plurality of connector portions includes at least two connector portions, but can include between 3 and 10 connector portions, preferably 4 connector portions. The first end 212 of the connector portion 210 is continuously formed with the center 215 of the connector 6, while the second end 214 is continuously formed with one end of the tube 4. The tube 4 can have the other end of the tube 4 connected to at least one of the bag assembly 8, the processing facility 10, another connector 6, or other processing devices for the pharmaceutical fluid or biological fluid.

[0018] Multiple tubes 4 and connectors 6 can be formed from various thermoplastic polymers and / or thermosetting elastomers so that the tubes and connectors are flexible. For example, tubes 4 and / or connectors 6 can be formed from thermoplastic polymers selected from the group consisting of fluoropolymers, polyurethanes, vulcanized products, flexible polyvinyl chloride (PVC), thermoplastic elastomers (TPE), high-density polyethylene (HDPE), ethylene vinyl acetate (EVA), copolymers / polyolefins, high-impact polystyrene (HIPS), polypropylene (PP), acrylonitrile butadiene styrene (ABS), polytetrafluoroethylene (PTFE, or ETFE), or mixtures thereof, or thermosetting elastomers or mixtures thereof such as liquid silicone rubber (LSR). Thus, the tubes and / or connectors are made from materials that remain flexible even at extremely low temperatures, such as -196°C. Tubes and connectors may be made from the same or different materials, but generally from materially compatible materials, for example, tubes and connectors having similar or the same thermal expansion / contraction coefficients, similar melting temperatures and flow properties, the same chemical resistance or compatibility, and / or other properties required by the application for the fluid connection assembly, such as UV protection. Tubes and / or connectors may also be made from relatively inert materials that do not leach or substantially absorb, and are non-reactive, for example, pharmaceutical or biological fluids.

[0019] FIG. 2B shows a cross-sectional view of the connector 6. The connector portion 210 is formed continuously with the tubes and is connected thereto such that an internal flow path 220 is formed continuously between the connector portion 210 and the plurality of tubes 4, and a mechanical connector is not used to connect them. Each of the connector portions 210 has an internal flow path having an inner diameter and an outer surface having an outer diameter. The internal flow path of the connector portion 210 is complementary to the outer surface of the tube 4 in configuration such that the tube 4 can be at least partially disposed within the connector portion 210. Thus, the connector portions 210 of the connector 6 are fluidly connected to each other and to the plurality of tubes 4 through the center 215 of the connector 6. In this embodiment, the connector 6 has an internal flow path having an inner diameter equal to or similar to the inner diameter of the tube 4, but it is recognized that the connector 6 can also have an internal flow path having an inner diameter larger or smaller than the inner diameter of the tube depending on the requirements for transporting pharmaceutical or biological fluids. For example, in one embodiment, when the central connector 6 is used to supply a pharmaceutical or biological fluid to a spinal assembly, the central connector 6 can have an internal flow path with a larger inner diameter to distribute the pharmaceutical or biological fluid to other connectors 6 of the spinal assembly having a smaller inner diameter connector 6 and / or tubing 4. That is, at least the sizing of the inner diameter of the connector and / or tubing is volume-dependent, and for example, the connector can be sized to be used as a reducer, an expander, or a combination thereof.

[0020] The connector portion 210, which is formed continuously with the pipe 4, can be carried out in various ways. For example, in one embodiment, the connector portion 210 is overmolded together with the pipe 4 in a single overmolding process using a single mold between a molding process (e.g., using thermosetting or injection molding), casting (e.g., two-part casting), thermoforming, etc. Thus, the connector portion 210 and the pipe 4 are formed from polymer together, either directly or continuously. In other embodiments, it is recognized that the connector portion 210 and the pipe 4 can be formed continuously using other processes, including but not limited to welding or joining techniques such as thermal bonding, impulse welding, laser welding, ultrasonic welding, platen welding, or similar fusion bonding / fusion welding techniques. In other words, it is recognized that the continuous formation of the connector portion and the pipe results in a connector assembly formed as a single unit, for example, a connector assembly that does not include a discontinuous connection in between, or does not use a clamp between the connector portion and the pipe, by using a joining process, fusion process, or molding process so that the pipe cannot be pulled out of the connector portion. Therefore, the connector assembly and the tube have a sufficiently high pull-out force so that there are no leakage points between the connector and the tube, even during cryogenic freezing.

[0021] In other words, although we do not wish to be constrained by theory, it was unexpectedly found that by continuously forming the connector portion and the tube, or by continuously forming the polymer of the connector portion and the tube, there is no need for a connector or clamp to attach the tube to the connector portion of the connector, thus eliminating potential leak points. In this case, at least the fluid connection assembly is formed continuously, so during cryogenic freezing processes at temperatures below -190°C, for example, the fluid connection system has no leak points and instead has an uninterrupted flow path from the process equipment through the fluid connection system. As a result, the fluid connection system maintains structural integrity and can prevent the ingress of cryogenic fluids, such as pharmaceutical or biological fluids. It was unexpectedly found that when the connector and tube are formed from the same or similar polymer, such as EVA, the connector and tube have the same or similar thermal shrinkage coefficient and / or thermal properties and / or material properties, such as rigidity. Therefore, at least the connector and tube shrink at the same rate, and thus have the same or similar thermal properties, for example, thus eliminating potential leak points and, as a result, maintaining the structural integrity of the system.

[0022] While the material of the connector 6 provides flexibility to the connector, it is recognized that the flexibility of the connector 6 can also be enhanced based on the structure of the connector 6. For example, the connector portion 210 is tapered into a conical shape, in which case the outer diameter of the first end 212 of the connector portion 210 is larger than the outer diameter of the second end 214 of the connector portion 210. Thus, having such a structure further enhances the flexibility of the connector portion 210.

[0023] As shown in Figure 2C, the connector 6 may also have additional strain relief sections to further enhance the flexibility of the connector 6. For example, each connector portion 210 may include a plurality of rib sections 230 provided along the outer surface of the conically tapered connector portion 210. The plurality of rib sections 230 are arranged in parallel along the length direction of the connector portion, in which case the rib section provided at the first end 212 closest to or near the center 215 of the connector 6 has a larger outer diameter than the rib section provided at the second end 214 of the connector portion connected to the pipe 4. Figure 2C includes four rib sections, but the number and arrangement of rib sections may be modified depending on the size / length of the connector, the size / length of the pipe, and various other factors to the design of the connector when used for fluid transfer, for example, it is recognized that the rib sections may be further spaced apart or closer together. Having such a structure, the connector portion 210 of the connector 6 can be further articulated, for example, moved, and as a result, when the pipe is moved or adjusted, the connector portion 210 is articulated and / or bent so that the pipe 4 is not subjected to stress, thereby preventing the formation of a restricting section in the flow path. In other words, since no kinking and / or tightening or buckling of the pipe occurs, the flow transition between the connector and the pipe is maintained, for example, maintaining a smooth flow curve along the flow path.

[0024] Figures 2C and 2D also show that the connector 6 may also have a portion to be removed around the center 215, or may have a center 215 that is thinner than the connector portion 210. That is, as seen in Figure 2D, the center 215 has a center portion 216 from which the material of the connector 6 has been removed, such that the center portion 216 has a thinner wall thickness than the rest of the connector 6, in which case the center portion has a rectangular shape, for example, the contour of a cube. It is recognized that the center portion 216 may also have other geometric shapes, such as conical, cylindrical, or similar shapes. Having a center portion 216 of the connector 6 with a thinner wall thickness and / or from which the material has been removed from the center portion further increases the flexibility of the connector 6, and as a result the connector portion 210 can move more articulately with the movement of the pipe, for example, so that there is no kinking, tightening, or buckling of the pipe when the pipe is moved, so that the flow transition between the pipe and the connector portion is not restricted.

[0025] It is recognized that the strain relief portion may include other structures to enhance the flexibility of the connector 6. Figure 3A shows one embodiment for enhancing the flexibility of a connector 306 including a strain relief portion, in which the outer surface of the connector portion 310 includes a helical rib section 320 provided longitudinally on the outer surface of the connector portion. The helical rib section 320 has a first end 316 located closer to the center 315 of the connector 306, and the first end 316 has a larger outer diameter than the helical rib section 310 at a second end 317 located at a second end 314 of the connector portion 310. The thickness of the helical rib section is shown in Figure 3A, but it is recognized that the thickness of the helical rib section may vary to provide flexibility to the connector portion. Furthermore, in some embodiments, as shown in Figure 3A, the center 315 of the connector 306 may include segmented core portions 330 provided between adjacent connector portions 310, in which case the material around the center 315 is removed to further enhance the flexibility of the connector portions 310, for example, allowing the connector portions 310 to move more articulately when the pipe 4 is moved.

[0026] Figure 3B shows a cross-sectional view of the connector 306 of Figure 3A. As seen in Figure 3B, in one embodiment, the connector 306 and the tube 4 may have the same or similar inner diameters, in which case the outer surface of the tube 4 is complementary to the inner surface of the connector portion 310. A contact surface 310A may be provided inside the connector 306 between the center 315 and the connector portion 310, in which case the tube 4 is in contact with the contact surface 310A to allow alignment prior to the continuous formation of the connector and the tube. It is recognized that the inner diameters of the connector 306 and the tube 4 may also be sized so that the tube 4 may have a larger or smaller inner diameter depending on the requirements of fluid transfer. That is, the sizing of the inner diameters of at least the connector and / or the tube is volume-dependent, and for example, the connector may be sized to be used as a reducer, expander, or a combination thereof.

[0027] Figure 4A shows another embodiment having a strain relief portion to enhance the flexibility of connector 406. In this embodiment, the strain relief portion of connector portion 410 includes a segmented portion 440 removed from the outer surface of connector portion 410. That is, the segmented portion is the remaining part of the connector portion from which the outer surface has been removed, resulting in a connector portion having a thickness equal to or the nominal thickness of the connector portion. For example, the remaining thickness of the connector portion in the segmented portion may be 10 to 60% of the nominal wall thickness, preferably 50% of the thickness, and may also be based on further variables such as the flexibility (durometer) of the piping, the characteristics of the piping during bending, the OM resin used, the geometry of the connector, for example, having sufficient thickness to maintain the strength and stability of connector portion 410, for example, having a thickness that can withstand system pressures between 20 and 100 psi, preferably about 30 psi, and / or pressure bursts between 100 and 300 psi. The segmented portions 440 may be provided on both sides of the connector portion 410 or alternately along the length of the connector portion to increase the flexibility of the connector portion. As seen in Figure 4A, the number of segmented portions 440 may be variable, for example, between one and four, and the design may be modified, for example, by removing portions on both sides along the length of the connector portion or by removing an entire section, or any combination thereof, to increase the flexibility of the connector portion.

[0028] Figure 4B shows a cross-sectional view of the connector 406 of Figure 4A. As seen in Figure 4B, in one embodiment, the connector 406 and the tube 4 may have the same or similar inner diameters, in which case the outer surface of the tube 4 is complementary to the inner surface of the connector portion 410. A contact surface 410A may be provided inside the connector 406 between the center 415 and the connector portion 410, in which case the tube 4 is in contact with the contact surface 410A to allow alignment before the continuous formation of the connector and the tube.

[0029] Figure 4C shows an alternative design for the connector 406 including a segmented portion 440. In this embodiment, the segmented portion 440 is a portion of the connector that has been removed from the connector portion 410 such that the segmented portion 440 extends through the connector portion 410, for example, the outer surface of the tube is exposed from the connector portion 410 through at least one or more of the segmented portions 440. It is recognized that such a design not only provides flexible strain relief but also allows the tube to be held in a specific position during the continuous formation of the connector and tube.

[0030] Figure 4D shows a cross-sectional view of the connector 406 in Figure 4C. As seen in Figure 4D, in one embodiment, the connector 406 and the tube 4 may have the same or similar inner diameters, in which case the outer surface of the tube 4 is complementary to the inner surface of the connector portion 410. A contact surface 410A may be provided inside the connector 406 between the center 415 and the connector portion 410, in which case the tube 4 is in contact with the contact surface 410A to allow alignment before the continuous formation of the connector and the tube.

[0031] Figure 4E shows another design of the connector 406 including segmented portions 440. In this embodiment, the segmented portions 440 are also portions of the connector portion 410 that have been removed from the connector portion 410 so that the segmented portions 440 extend through the connector portion 410, for example, the outer surface of the tube is exposed from the connector portion 410 through at least one or more of the segmented portions 440. In this embodiment, the segmented portions 440 are provided in a parallel arrangement along the length of the connector portion 410. It is recognized that such a design not only provides flexible strain relief but also allows the tube to be held in a specific position during the continuous formation of the connector and tube.

[0032] Figure 4F shows a cross-sectional view of the connector 406 of Figure 4E. As seen in Figure 4F, in one embodiment, the connector 406 and the tube 4 may have the same or similar inner diameters, in which case the outer surface of the tube 4 is complementary to the inner surface of the connector portion 410. A contact surface 410A may be provided inside the connector 406 between the center 415 and the connector portion 410, in which case the tube 4 is in contact with the contact surface 410A to allow alignment before the continuous formation of the connector and the tube.

[0033] Figure 4G shows another design of the connector 406 including a segmented portion 440. In this embodiment, the segmented portion 440 is provided in parallel along the length of the connector portion 410 and is the remaining portion of the connector portion after it has been removed from the outer surface of the connector portion 410. In other words, the segmented portion 410 is the remaining portion of the connector portion after its outer surface has been removed, and as a result, the segmented portion gives the connector portion a thickness equal to or the nominal thickness of the connector portion. For example, the remaining thickness of the connector portion in the segmented portion may be 10 to 60% of the nominal thickness, preferably 50% of the thickness, and may also be based on further variables such as the flexibility (durometer) of the piping, the characteristics of the piping during bending, the OM resin used, the geometry of the connector, for example, having sufficient thickness to maintain the strength and stability of the connector portion 410, for example, having a thickness that can withstand system pressures between 20 and 100 psi, preferably about 30 psi, and / or pressure bursts between 100 and 300 psi.

[0034] Figure 4H shows a cross-sectional view of the connector 406 of Figure 4G. As seen in Figure 4H, in one embodiment, the connector 406 and the tube 4 may have the same or similar inner diameters, in which case the outer surface of the tube 4 is complementary to the inner surface of the connector portion 410. A contact surface 410A may be provided inside the connector 406 between the center 415 and the connector portion 410, in which case the tube 4 is in contact with the contact surface 410A to allow alignment before the continuous formation of the connector and the tube.

[0035] The segmented portions 440 shown in Figures 4A to 4H, which have been removed or partially removed, may be of various designs and may be combined in various combinations to provide strain relief to the connector portion without departing from the scope of various embodiments.

[0036] While connector design has been discussed in relation to strain relief portions on the outer surface of the connector portion, it is also recognized that various features may extend at least partially through the inner surface of the connector portion, for example, through the wall thickness. Therefore, at least a portion of the ribs, helical portions, and / or segmented portions may extend into the inner surface so that the ribs, helical portions, and / or segmented portions can intersect with the tube inserted into the connector portion in order to maintain the position of the tube during the molding process.

[0037] The above embodiment shows a connector having four connector portions arranged as a four-arm cross design, but it is recognized that the connector may be provided in different design configurations within various embodiments depending on the number of connector portions. For example, the connector may include multiple connector portions arranged as a four-arm cross mold design, a six-arm cross mold design (or star mold design), a T-mold design, a Y-mold design, an elbow mold design, or any combination thereof. The connector design configuration may be selected based on the number of bag assemblies to be filled, the layout of the bag assemblies or processing equipment, or other design considerations. For example, the connector may be configured as a reducer, expander, or a combination thereof when it is necessary to connect pipes or components of different sizes.

[0038] For example, as shown in Figure 5A, the connector 506 includes three connector portions 510 in the y-mold design. In this embodiment, the connector portions 510 extend from the center 515 of the connector 506 in the y-design, in which case one of the tubes 4 may be provided to supply a pharmaceutical or biological fluid to the other two connector portions 510. The connector portion 510 includes a plurality of rib sections 530 provided parallel to the length of the outer surface of the connector portion 510, in which case the rib section provided at the first end 512 closest to or near the center 515 of the connector 506 has a larger outer diameter than the rib section provided at the second end 514 of the connector portion connected to the tube 4.

[0039] Figure 5B shows a cross-sectional view of the connector 506 of Figure 5A. As seen in Figure 5B, in one embodiment, the connector 506 and the tube 4 may have the same or similar inner diameters, in which case the outer surface of the tube 4 is complementary to the inner surface of the connector portion 510. A contact surface 510A may be provided inside the connector 506 between the center 515 and the connector portion 510, in which case the tube 4 is in contact with the contact surface 510A to allow alignment before the continuous formation of the connector and the tube.

[0040] Figure 5C shows another design of the connector portion, in which six connector portions 510 are provided as a six-arm cross mold design (or star mold design). In this embodiment, the connector portions 510 extend from the center 515 of the connector 506 in the six-arm cross or star design, in which case one(s) of the tubes 4 may be provided to supply a pharmaceutical or biological fluid to the other connector portions 510. The connector portion 510 includes a plurality of rib sections 530 provided parallel to the length of the outer surface of the connector portion 510, in which the rib section provided at the first end 512 closest to or near the center 515 of the connector 506 has a larger outer diameter than the rib section provided at the second end 514 of the connector portion that connects to the tubes 4.

[0041] Figure 5D shows a cross-sectional view of the connector 506 in Figure 5C. As seen in Figure 5D, in one embodiment, the connector 506 and the tube 4 may have the same or similar inner diameters, in which case the outer surface of the tube 4 is complementary to the inner surface of the connector portion 510. A contact surface 510A may be provided inside the connector 506 between the center 515 and the connector portion 510, in which case the tube 4 is in contact with the contact surface 510A to allow alignment before the continuous formation of the connector and the tube.

[0042] Figure 5E shows another design of the connector portion, in which five connector portions 510 are provided as a multi-port design. In this embodiment, the connector portions 510 extend from the center 515 of the connector 506, and in this case, the connector portions connected to the supply pipes have a larger inner diameter than the remaining connector portions 510. For example, the horizontally positioned pipes 4A and 4B in Figure 5E may be used to supply pharmaceutical or biological fluids to a bag assembly through pipes 4C, 4D, and 4E. In one embodiment, the connector portions 510 may have a size similar to the size of the pipes, for example, the connector portions 510 connected to pipes 4A and 4B have a larger inner and / or outer diameter than the remaining connector portions 510 of the connector 506. Thus, the connector 506 may be used as an expander, a reducer, or a combination thereof. Similar to the embodiments described above, the connector portion 510 includes a plurality of rib sections 530 provided parallel to the length of the outer surface of the connector portion 510, in which case the rib section provided at the first end 512 closest to or near the center 515 of the connector 506 has a larger outer diameter than the rib section provided at the second end 514 of the connector portion connected to the pipe 4. Thus, the rib sections provided at the connecting portions 510 connected to pipes 4A and 4B have a larger outer diameter than the rib sections on the connecting portions 510 connected to pipes 4C, 4D, and 4E.

[0043] The connector may include a single design configuration or a combination of various design configurations, and it is recognized that, for example, various features of various embodiments of the connector may be combined with other designs or the same design of the connector. For example, as seen in Figure 5F, the spine assembly 500 may include a connector 506 that uses any combination of design configurations for the distribution of pharmaceutical or biological fluids into a bag assembly, and for example, the mold may include a four-arm cross mold design to form the connector. The connector 506 has a plurality of conically tapered connector portions 510, where the outer diameter of the first end 512 at a plurality of centers 515 of the connector 506 is greater than the outer diameter of the second end 514. Thus, each of the connector portions 510 is flexible and can be articulated, for example, when the bag assembly is moved, and as a result, there are no flow restrictions, such as kinking or pinching, in the flow transition between the tube 4 and the connector portion 510. It is also recognized that the flexibility of the connector portion can reduce catch points or snag points during the movement of the bag assembly (and tubes) and / or during the packaging of the system.

[0044] In other words, all embodiments of connectors 6, 306, 406, and 506 are formed with a structure that overcomes the shortcomings of conventional connector designs. For example, since the connector includes a connector portion formed continuously with the tube, the tube and connector portion do not require a mechanical connector to connect the tube and connector portion, and no gap is created between the piping and the connector along the internal flow path. Thus, the connector structure avoids the formation of pockets that accumulate fluid and lead to contamination and damage to cells, and the internal flow path is smooth while maintaining sufficient pull force. Furthermore, since the connector and tube are formed continuously in some embodiments, it has been surprisingly found that if the connector and pipe are made of the same or similar material, for example, having the same or similar thermal properties, the fluid connection assembly can be used in cryogenic processes while maintaining the structural integrity of the system, for example, preventing leakage and / or contamination. For example, the connector can withstand impact tests at -196°C and freeze-drop tests at -195°C and can be used in freeze-thaw applications.

[0045] Furthermore, connectors 6, 306, 406, and 506 are flexible, and the connector portion can be articulated when the pipe is moved. Therefore, when, for example, the bag assembly or processing equipment is moved, the pipe is not bent, kinked, or constricted, and as a result, no interruption in the flow path between the pipe and the connector portion is created. Thus, the fluid connection assembly can be used to transfer a fixed amount of pharmaceutical or biological fluid to the bag assembly, and a consistent flow can be maintained across the fluid connection assembly, for example, because no interruption in the flow is created.

[0046] Referring to Figure 6, a flowchart for method 600 for manufacturing a fluid connection assembly is shown. For example, method 600 may be used to manufacture the fluid connection assemblies in Figures 1 to 5F. Starting from S610, a plurality of tubes are formed having a first open end and a second open end opposite the first open end. In S620, a plurality of connectors are formed, in this case each connector is formed to have a plurality of connector portions. Each connector portion is formed to have a first end connected to the center of the connector and a second open end. Each connector portion is formed to be tapered into a cone shape, where the outer diameter of the first end at the center of the connector is greater than the outer diameter of the second end of the connector portion, so that the connector portion is flexible.

[0047] In S630, a plurality of tubes, for example, at least three tubes, and one of the connectors are arranged within the mold. It is recognized that the tube is inserted into the connector portion of the connector such that mechanical friction holds the tube and the connector portion together. For example, the tube may be inserted into the second end of the connector portion until the open end of the tube abuts against an internal surface provided along the internal flow path of the connector portion, or until it is inserted to a position of at least one-quarter, preferably one-half, of the length of the connector portion. Thus, the tube is fluidly connected to the center of the connector and to the other connector portions of the connector.

[0048] In S640, the connector is overmolded with the tube within a mold. The overmolding process can occur as a single overmolding process using a single mold between molding processes (e.g., using thermosetting or injection molding), casting (e.g., two-part casting), thermoforming, etc. For example, if a thermosetting material is used, the thermosetting resin material, such as silicone, is placed in a mold pin together with a catalyst or other resin. The mold pin is then heated to a controlled temperature, for example, set to a controlled temperature, or the thermosetting resin material is cured to form a connector overmolded with the tube. Alternatively, an injection molding method may be used in which a thermoplastic is injected into the mold to overmolde the connector portion and the tube. Thus, the connector and the connector portion and the tube are formed directly or continuously from each other by the polymer.

[0049] In S650, the process is repeated for each connector and pipe assembly to form a vertebral assembly of the fluid connection assembly, for example by sequential overmolding, by moving the mold pins to the remaining connectors and continuously forming the connector portion of the connector with the other pipe assemblies.

[0050] manner Any of embodiments 1 to 9 can be combined with any of embodiments 10 to 16 and / or embodiments 17 to 18, and vice versa.

[0051] Embodiment 1. A plurality of pipes having a first open end and a second open end opposite the first open end, A plurality of connectors, each of which comprises at least two connector portions, each of which has a first end extending from the center of the connector and connected to the center of the connector, and a second end connected to a second open end of one of the plurality of tubes, wherein the connector portions are formed continuously with the tubes and the center of the connectors, and the connector portions are fluidly connected to one another. A fluid connection assembly comprising, A fluid connection assembly in which each of at least two connector portions is tapered in a conical shape, and the outer diameter of the first end at the center of the connector is greater than the outer diameter of the second end of the connector portion, such that the connector portion is flexible.

[0052] Embodiment 2. The fluid connection assembly according to Embodiment 1, wherein the connector portion comprises a strain relief portion provided along the outer surface of each connector portion.

[0053] Embodiment 3. The fluid connection assembly according to Embodiment 2, wherein the strain relief portion comprises a plurality of rib sections arranged parallel to each other along the length of the connector portion, and the rib sections located closer to the center of the connector have a larger outer diameter than the rib sections located at the second end of the connector portion.

[0054] Embodiment 4. A fluid connection assembly according to Embodiment 2, wherein the strain relief portion comprises a spiral rib section provided along the longitudinal direction of the connector portion, and the first end of the spiral rib section provided closer to the center of the connector has a larger outer diameter than the second end of the spiral rib section provided at the second end of the connector portion.

[0055] Embodiment 5. The fluid connection assembly of Embodiment 2, wherein the strain relief portion comprises a segmented core portion removed from the outer surface of the connector portion.

[0056] Embodiment 6. A fluid connection assembly according to Embodiment 2, wherein the connector comprises a thermoplastic elastomer or a thermosetting material.

[0057] Embodiment 7. The fluid connection assembly according to Embodiment 6, wherein the thermoplastic elastomer is ethylene vinyl acetate (EVA) or silicone.

[0058] Embodiment 8. A fluid connection assembly according to any one of Embodiments 1 to 7, wherein the connector has a design selected from the group consisting of a 4-arm cross mold, a 6-arm star mold, a T mold, a Y mold, an elbow mold, and combinations thereof, as a reducer.

[0059] Embodiment 9. A fluid connection assembly according to Embodiments 1 to 8, wherein the first end opening of one of the multiple pipes is fluidly connected to a bag assembly.

[0060] Embodiment 10. At least two connector portions, each having a first end extending from the center of the connector and connected to the center of the connector, and a second end extending laterally from the center of the connector, formed continuously with the center of the connector, and fluidly connected to each other. A connector equipped with, A connector in which at least two connector portions are tapered in a conical shape, and the outer diameter of the first end at the center of the connector is greater than the outer diameter of the second end of the connector portion, such that the connector portion is flexible.

[0061] Embodiment 11. The connector according to Embodiment 10, wherein the connector portion includes a strain relief portion provided along the outer surface of each connector portion.

[0062] Embodiment 12. The connector according to Embodiment 11, wherein the strain relief portion comprises a plurality of rib sections arranged parallel to each other along the length of the connector portion, and the rib sections located closer to the center of the connector have a larger outer diameter than the rib sections located at the second end of the connector portion.

[0063] Embodiment 13. The connector according to Embodiment 11, wherein the strain relief portion comprises a spiral rib section provided along the longitudinal direction of the connector portion, and the first end of the spiral rib section provided closer to the center of the connector has a larger outer diameter than the second end of the spiral rib section provided at the second end of the connector portion.

[0064] Embodiment 14. The connector according to Embodiment 11, wherein the strain relief portion comprises a block core portion removed from the outer surface of the connector portion.

[0065] Embodiment 15. A connector comprising any one of Embodiments 10 to 14, comprising a thermoplastic elastomer.

[0066] Embodiment 16. The connector according to Embodiment 15, comprising thermoplastic ethylene vinyl acetate (EVA).

[0067] Embodiment 17. A method for manufacturing a fluid connection assembly, To form a plurality of tubes having a first open end and a second open end opposite the first open end, The present invention relates to forming a plurality of connectors, each of which is formed to have at least two connector portions, each of which has a first end extending from the center of the connector and connected to the center of the connector, and a second end connected to a second open end of one of the plurality of tubes, wherein the connector portions are fluidly connected to one another. Overmolding at least one of the two connector portions and the second open end of one of the multiple tubes so that the connector portion is fluidly connected to the center of the connector and the tube, Includes, A method wherein each of at least two connector portions is formed to be tapered in a conical shape, and the outer diameter of the first end at the center of the connector is greater than the outer diameter of the second end of the connector portion, such that the connector portion is flexible.

[0068] Embodiment 18. The method of Embodiment 17, wherein the overmolding step occurs in a single step.

[0069] The examples disclosed in this application should be considered in all respects to be illustrative and not restrictive. The scope of the invention is indicated by the appended claims rather than by the foregoing description, and all modifications that fall within the meaning and scope of the equivalents of the claims are intended to be encompassed within the claims.

Claims

1. A plurality of pipes having a first open end and a second open end opposite the first open end, A plurality of connectors, each of which comprises at least two connector portions, each of which has a first end extending from the center of the connector and connected to the center of the connector, and a second end connected to the second open end of one of the plurality of tubes, wherein the connector portions are formed continuously with the tubes and the center of the connectors, and the connector portions are fluidly connected to one another. A fluid connection assembly comprising, A fluid connection assembly in which each of the at least two connector portions is tapered into a cone shape, and the outer diameter of the first end at the center of the connector is greater than the outer diameter of the second end of the connector portion, such that the connector portion is flexible.

2. The fluid connection assembly according to claim 1, wherein the connector portion comprises a strain relief portion provided along the outer surface of each of the connector portions.

3. The fluid connection assembly according to claim 2, wherein the strain relief portion comprises a plurality of rib sections arranged in parallel along the length of the connector portion, and the rib sections located closer to the center of the connector have a larger outer diameter than the rib sections located at the second end of the connector portion.

4. The fluid connection assembly according to claim 2, wherein the strain relief portion comprises a spiral rib section provided along the length of the connector portion, and the first end of the spiral rib section provided closer to the center of the connector has a larger outer diameter than the second end of the spiral rib section provided at the second end of the connector portion.

5. The fluid connection assembly according to claim 2, wherein the strain relief portion comprises a segmented core portion removed from the outer surface of the connector portion.

6. The fluid connection assembly according to any one of claims 1 to 5, wherein the connector comprises a thermoplastic elastomer or a thermosetting material.

7. The fluid connection assembly according to claim 6, wherein the thermoplastic elastomer is ethylene vinyl acetate (EVA) or silicone.

8. The fluid connection assembly according to any one of claims 1 to 7, wherein the connector has a design selected from the group consisting of a four-arm cross mold, a six-arm star mold, a T mold, a Y mold, an elbow mold, and combinations thereof, as a reducer.

9. The fluid connection assembly according to any one of claims 1 to 8, wherein the first end opening of one of the plurality of pipes is fluidly connected to the bag assembly.

10. At least two connector portions, each having a first end extending from the center of the connector and connected to the center of the connector, and a second end extending laterally from the center of the connector, formed continuously with the center of the connector, and fluidly connected to each other. A connector equipped with, A connector in which each of the at least two connector portions is tapered into a cone shape, and the outer diameter of the first end at the center of the connector is greater than the outer diameter of the second end of the connector portion, such that the connector portion is flexible.

11. The connector according to claim 10, wherein the connector portion comprises a strain relief portion provided along the outer surface of each of the connector portions.

12. The connector according to claim 11, wherein the strain relief portion comprises a plurality of rib sections arranged in parallel along the length of the connector portion, and the rib sections located closer to the center of the connector have a larger outer diameter than the rib sections located at the second end of the connector portion.

13. The connector according to claim 11, wherein the strain relief portion comprises a helical rib section provided along the length of the connector portion, and the first end of the helical rib section provided closer to the center of the connector has a larger outer diameter than the second end of the helical rib section provided at the second end of the connector portion.

14. The connector according to claim 11, wherein the strain relief portion comprises a block core portion removed from the outer surface of the connector portion.

15. The connector according to claim 10, comprising a thermoplastic elastomer.

16. The connector according to claim 15, comprising thermoplastic ethylene vinyl acetate (EVA).

17. A method for manufacturing a fluid connection assembly, To form a plurality of tubes having a first open end and a second open end opposite the first open end, The present invention relates to forming a plurality of connectors, each of which is formed to have at least two connector portions, each of which has a first end extending from the center of the connector and connected to the center of the connector, and a second end connected to the second open end of one of the plurality of tubes, and the connector portions are fluidly connected to one another. Overmolding at least one of the two connector portions and the second open end of one of the plurality of tubes so that the connector portion is fluidly connected to the center of the connector and the tube, Includes, A method wherein each of the at least two connector portions is formed to be tapered in a conical shape, and the outer diameter of the first end at the center of the connector is greater than the outer diameter of the second end of the connector portion, such that the connector portion is flexible.

18. The method according to claim 17, wherein the overmolding step occurs in a single step.

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