Fluid transfer assembly having a junction with multiple fluid paths - Patents.com

Abstract

A fluid transfer assembly is described. The fluid transfer assembly includes a single junction having an upstream portion and a downstream portion, the single junction defining a plurality of curved fluid paths between the upstream portion and the downstream portion. The assembly further includes at least one flexible fluid conduit sealed to the junction so as to be in fluid communication with at least one of the plurality of curved fluid paths. [Selected Figure] Figure 1

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 62 / 585,699, filed November 14, 2017.

[0002] (Incorporated by reference) U.S. Provisional Patent Application No. 62 / 585,699, filed November 14, 2017, is incorporated herein by reference for all purposes as if set forth herein in its entirety.

[0003] The present disclosure relates generally to a junction that allows for the transfer of a fluid, particularly a liquid, mixture, or suspension, from a source to a destination via at least one flexible conduit. The present disclosure particularly relates to an assembly having a junction for use in an aseptic system. [Background technology]

[0004] Biopharmaceutical and pharmaceutical developers and manufacturers often develop and manufacture fluid products that must be handled with care to maintain a sterile environment and avoid contamination. Drugs developed and manufactured by biopharmaceutical and pharmaceutical companies are often manufactured through multiple steps that may require the transfer of fluids through conduits for sampling, packaging, mixing, separation, or passage between stations for various steps in the manufacturing process.

[0005] The manufacturing and testing processes required by biopharmaceutical and pharmaceutical companies require significant opportunities for fluid transfer. Every time a fluid transfer occurs that relies on separate containers, conduits, or components to leave a source and reach a destination, an opportunity exists for a leak to occur or for contamination to occur.

[0006] Often, multiple fluid paths are required to enter and exit various containers. Traditionally, the fluid paths have all been maintained independently of one another, requiring numerous separate fittings between the conduits and a significant amount of space to separately accommodate the fittings for each fluid path.

[0007] This disclosure describes improvements to maintain a sterile environment and avoid contamination during fluid transfer by minimizing leak points, increasing fluid path organization, reducing space requirements, and simplifying assembly to produce a reliable, low-cost fluid transfer assembly. Because fluid transfer assemblies are often sterile and intended for single use, reducing assembly steps and maintaining low cost can provide significant advantages. Summary of the Invention

[0008] An embodiment of the present disclosure includes a fluid transfer assembly comprising a single junction having an upstream portion and a downstream portion, the single junction defining a plurality of curved fluid paths between the upstream portion and the downstream portion, the assembly further including at least one flexible fluid conduit sealed to the junction in fluid communication with at least one of the plurality of curved fluid paths.

[0009] Another embodiment of the present disclosure comprises a fluid transfer assembly including a single junction having an upstream portion and a downstream portion, the single junction defining a plurality of curved fluid paths between the upstream portion and the downstream portion. The assembly further includes at least one flexible fluid conduit connected (e.g., sealed) to the junction in fluid communication with at least one of the plurality of curved fluid paths. At least one of the upstream portion and the downstream portion includes a plurality of male inserts corresponding to the plurality of fluid paths, respectively, configured to be inserted into the at least one fluid conduit to facilitate fluid communication. The single junction is formed from multiple layers of material, each layer having approximately the same thickness.

[0010] A further embodiment of the present disclosure includes a method of manufacturing a fluid transfer assembly. The method includes using an additive manufacturing device to form successive layers of material to form a single junction having an upstream portion and a downstream portion, the single junction defining a plurality of curved fluid paths between the upstream portion and the downstream portion. At least one of the upstream portion and the downstream portion includes a plurality of male inserts corresponding to the plurality of fluid paths, respectively. The method further includes inserting at least one of the plurality of male inserts into a lumen of a flexible fluid conduit and securing the flexible fluid conduit to the junction.

[0011] These and other aspects of the present disclosure will become apparent to those skilled in the art after reviewing the following description of the preferred embodiments in conjunction with the drawings. It is to be understood that both the foregoing general description and the following detailed description are explanatory only and are not restrictive of the invention as claimed. [Brief explanation of the drawings]

[0012] [Figure 1] 1 shows a fluid transfer assembly according to a first embodiment. [Figure 1A] 2 illustrates the fluid transfer assembly of FIG. 1 with optional additional components. [Figure 2] 2 shows a longitudinal cross section of the fluid transfer assembly of FIG. 1; [Figure 3] 2 shows a first perspective view of a junction of the fluid transfer assembly of FIG. 1; [Figure 4] 2 shows a second perspective view of the junction of the fluid transfer assembly of FIG. 1; [Figure 5] 2 shows a first end view of a junction of the fluid transfer assembly of FIG. 1; [Figure 6] 2 shows a second end view of the junction of the fluid transfer assembly of FIG. 1; [Figure 7] 2 shows a side view of a junction of the fluid transfer assembly of FIG. 1; [Figure 8] 1 shows a perspective view of a fluid transfer assembly according to a second embodiment. [Figure 9] 1 shows a perspective view of a fluid transfer assembly according to a second embodiment. [Figure 10] 10 shows a longitudinal cross section of the fluid transfer assembly of FIGS. 8 and 9. [Figure 11] 10 shows a perspective view of a junction according to the embodiment of FIGS. 8 and 9; FIG. [Figure 12] 10 shows a perspective view of a junction according to the embodiment of FIGS. 8 and 9; FIG. [Figure 13] A side view of the junction in Figs. [Figure 14] An end view of the junction of Figs. [Figure 15] An end view of the junction of Figs. [Figure 16] 10 shows a fluid transfer assembly according to a third embodiment. [Figure 17] 17 shows a diagram of a junction used in the fluid transfer assembly of FIG. 16. [Figure 18] 17 shows a diagram of a junction used in the fluid transfer assembly of FIG. 16. [Figure 19] 17 shows a diagram of a junction used in the fluid transfer assembly of FIG. 16. [Figure 20] 17 shows a diagram of a junction used in the fluid transfer assembly of FIG. 16. [Figure 21] 17 shows a diagram of a junction used in the fluid transfer assembly of FIG. 16. [Figure 22] 10 shows a fluid transfer assembly according to a fourth embodiment. [Figure 23] 23 shows a view of a junction of the fluid transfer assembly of FIG. 22. [Figure 24] 23 shows a view of a junction of the fluid transfer assembly of FIG. 22. [Figure 25] 23 shows a view of a junction of the fluid transfer assembly of FIG. 22. [Figure 26] 23 shows a view of a junction of the fluid transfer assembly of FIG. 22. [Figure 27] 23 shows a view of a junction of the fluid transfer assembly of FIG. 22. [Figure 28] 23 shows a view of a junction of the fluid transfer assembly of FIG. 22. [Figure 29] 23 shows a view of a junction of the fluid transfer assembly of FIG. 22. [Figure 30] Another cross section of the junction according to Fig. 23-29 is shown. [Figure 31] FIG. 9 shows a diagram of a junction suitable for use with the fluid transfer assembly of FIGS. [Figure 32] FIG. 9 shows a diagram of a junction suitable for use with the fluid transfer assembly of FIGS. [Figure 33] FIG. 9 shows a diagram of a junction suitable for use with the fluid transfer assembly of FIGS. [Figure 34] FIG. 9 shows a diagram of a junction suitable for use with the fluid transfer assembly of FIGS. [Figure 35] FIG. 9 shows a diagram of a junction suitable for use with the fluid transfer assembly of FIGS. [Figure 36] FIG. 9 shows a diagram of a junction suitable for use with the fluid transfer assembly of FIGS. [Figure 37] 10 shows a diagram of yet another embodiment of a junction suitable for use in a fluid transfer assembly according to an embodiment of the present disclosure. [Figure 38] 10 shows a diagram of yet another embodiment of a junction suitable for use in a fluid transfer assembly according to an embodiment of the present disclosure. [Figure 39] 10 shows a diagram of yet another embodiment of a junction suitable for use in a fluid transfer assembly according to an embodiment of the present disclosure. [Figure 40] 10 shows a diagram of yet another embodiment of a junction suitable for use in a fluid transfer assembly according to an embodiment of the present disclosure. [Figure 41] 10 shows a diagram of yet another embodiment of a junction suitable for use in a fluid transfer assembly according to an embodiment of the present disclosure. [Figure 42] 10 shows a diagram of yet another embodiment of a junction suitable for use in a fluid transfer assembly according to an embodiment of the present disclosure. [Figure 43] 10 shows a diagram of yet another embodiment of a junction suitable for use in a fluid transfer assembly according to an embodiment of the present disclosure. [Figure 44] 10 shows a perspective view of a junction according to a further embodiment of the present disclosure; [Figure 45] 10 shows a perspective view of a junction according to a further embodiment of the present disclosure; [Figure 46] 10 shows a cross-sectional view of a junction according to a further embodiment of the present disclosure; [Figure 47] 10 shows a cross-sectional view of a junction according to a further embodiment of the present disclosure; [Figure 48] 44-47 illustrate adapters or fittings for use with the junctions shown in FIGS. [Figure 49] 10 shows a perspective view of a junction according to a further embodiment of the present disclosure; [Figure 50] 10 shows a perspective view of a junction according to a further embodiment of the present disclosure; [Figure 51] 10 shows a cross-sectional view of a junction according to a further embodiment of the present disclosure; [Figure 52] 10 shows a cross-sectional view of a junction according to a further embodiment of the present disclosure; [Figure 53] FIG. 10 shows a side view of a junction according to another embodiment of the present disclosure. [Figure 54] 1 illustrates a fluid transfer assembly according to one aspect of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0013] Exemplary embodiments of the present disclosure are described below and illustrated in the accompanying drawings, in which like numerals refer to like parts throughout the several views. The described embodiments provide examples and should not be construed as limiting the scope of the invention. Other embodiments, as well as modifications and improvements to the described embodiments, will be apparent to those skilled in the art, and all such other embodiments, modifications, and improvements are within the scope of the present invention. Features from one embodiment or aspect may be combined with features from any other embodiment or aspect in any suitable combination. For example, any individual or collective feature of a method aspect or embodiment may be applied to an apparatus, product, or component aspect or embodiment, and vice versa.

[0014] 1 illustrates a fluid transfer assembly 100 suitable for aseptically transferring liquids, mixtures, or suspensions during biopharmaceutical and pharmaceutical manufacturing. The fluid transfer assembly 100 is intended to provide a sterile fluid transfer pathway. The fluid transfer assembly 100 is not particularly limited to use in pharmaceutical development or manufacturing.

[0015] The fluid transfer assembly 100 is shown with multiple fluid conduits 102 attached to a junction 104. In the illustrated embodiment, the fluid conduits 102 are attached to both an upstream and downstream portion of the junction 104. In other embodiments, either the upstream or downstream portion of the junction 104 may be attached to a tank or other vessel.

[0016] As used herein, the terms upstream and downstream are used for clarity to refer to any direction of fluid flow through junction 104. Those skilled in the art will understand that the junction 104 described herein is not particularly limited to a particular flow direction. Thus, although the upstream and downstream portions are distinct, they can be reversed so that the upstream side becomes the downstream side, and vice versa, simply by reversing the flow of fluid through the junction during use. Thus, in some embodiments, junction 104 can be used in either flow direction.

[0017] The conduit 102 is preferably a flexible conduit suitable for use in a medical environment. The conduit 102 can be constructed of a thermosetting or thermoplastic polymer. When a thermosetting material is used, silicone, polyurethane, fluoroelastomer, or perfluoropolyether are preferred materials of construction for the conduit. When a thermosetting material is used, C-Flex® tubing, styrene-ethylene-butylene-styrene block copolymer, PureWeld, PVC, polyolefin, polyethylene, and blends of EPDM and polypropylene (such as Santoprene®) are preferred materials of construction. Semi-rigid thermoplastics, including but not limited to fluoropolymers PFA, PEP, PTFR, THV, PVDF, and other thermoplastics such as polyamide, polyethersulfone, polyolefin, polystyrene, and PEEK, can also be used in one or more portions or sections of the conduit to make them flexible. Multiple conduits 102 attached to the junction 104 can be made from different materials. In some embodiments, at least one of the conduits 102 attached to the junction may be a rigid conduit.

[0018] The conduit 102 may be of various sizes in outer and inner diameters depending on the intended use of the fluid transfer assembly 100. The conduit 102 may be a single lumen conduit as shown in Figure 1 or a multi-lumen conduit as shown in Figure 9. If the conduit 102 includes multiple lumens, each lumen may be the same diameter or cross-section, or the lumens may have multiple diameters or cross-sections within a single conduit 102.

[0019] 1A, the conduit 102 may extend from or lead to additional components 105, which may form part of the fluid transfer assembly. The additional components 105 may include one or more containers, including but not limited to vessels, beakers, jars, canisters, flasks, bags, receptacles, tanks, vats, vials, tubing, syringes, carboys, tanks, pipes, etc., commonly used to contain liquids, slurries, and other similar substances. The containers may be closed with MYCAP®, available from Sartorius Stedim North America. The conduit 102 may terminate in a component 105 that includes an ApeptiQuik® connector available from Colder Products Company of St. Paul, Minnesota, a BENCHMARK® fitting available from Sartorius Stedim North America, an OPTA sterile connector available from Sartorius Stedim North America, a ReadyMate connector available from GE Healthcare of Chicago, Illinois, or other terminus such as a syringe, centrifuge tube, or plug. The embodiment shown in FIG. 1A includes a junction 104 and multiple conduits 102 leading to the following optional exemplary components: a 3 / 8" hose barb ApeptiQuik® sterile connector 105a; a 60 ml bottle assembly with MYCAP® 105b; a 50 ml centrifuge tube assembly with MYCAP® 105c; a 50 ml bag assembly 105d; a dual stopcock valve assembly 105e with a 15 ml centrifuge tube 105f, a 30 ml bottle with MYCAP® 105g, and a 500 ml purge bag 105h; an ApeptiQuik® sterile connector 105i; a 10 cc syringe 105j; a capped needleless access site 105k; and a capped luer fitting 105l. Some of the conduits 102 are provided with Quickseal® 105m, available from Sartorius Stedim North America.The example shown in FIG. 1A is intended to illustrate a small sample of available containers, connectors, and fittings that can be used in fluid communication with junction 104 and is not intended to limit the present disclosure.

[0020] Figure 2 shows a cross-sectional view of junction 104. Figures 3-7 show various perspective and top views of junction 104 according to one embodiment. In particular, Figure 7 shows a side view of junction 104 shown as rotationally symmetric.

[0021] The junction 104 is preferably constructed as a single, unitary body. Once manufactured, the junction 104 is one piece and does not require the assembly of two or more parts. A single, unitary body can be formed from processes known in the art, such as injection molding, machined cast parts, or other similar processes. As used herein, additive manufacturing processes also produce a "single" body. In one embodiment, the junction 104 is manufactured using an additive manufacturing process. As known in the art, additive manufacturing, also known as 3D printing, involves building a material by stacking thin layers of substantially similar thicknesses on top of each other to form a body. Thus, in some embodiments, the junction 104 of the present disclosure may be a "single" body or may be formed from multiple layers of material, each layer having approximately the same thickness. In traditional additive manufacturing, layers are built up one on top of the layer below. Alternatively, in another embodiment, the present disclosure can use CLIP technology, such as that offered by Carbon, Inc. of Redwood City, California, which uses, for example, digital light synthesis, a pattern of light to partially cure product layers, layer by layer, so that as a body of cured or semi-cured material is lifted from a reservoir of uncured material, the uncured material is cured to the bottom of the stack.

[0022] Suitable materials for the junction 104 include thermoplastics such as polyolefins, polypropylene, polyethylene, polysulfone, polyester, polycarbonate, and glass-filled thermoplastics. The junction may also be made from thermoset materials such as epoxies, phenolics, silicones, and copolymers of silicone and novolac. Other suitable materials include polyamides, PEEK, PVDF, polysulfones, cyanate esters, polyurethanes, and urethane methacrylates. However, metallic materials such as stainless steel, aluminum, titanium, etc., or ceramics such as aluminum oxide can also be used. However, the present disclosure is not limited to junctions made from any particular material, and any suitable materials or combinations thereof can be used without departing from the scope of the present disclosure.

[0023] Additive manufacturing techniques may enable the creation of structures that cannot be produced by traditional molding or machining processes. These structures result in reduced packaging space and fewer components, which helps reduce leak points and reduce the cost of assembling the fluid transfer assembly 100.

[0024] In some embodiments, the junction 104 may be surface treated to affect its appearance, hydrophobicity, and / or surface roughness. Minimizing surface roughness is particularly desirable in bioprocessing to minimize the likelihood of trapped bacteria. Examples of surface treatments include metallizing with electroless nickel, copper, or other metals to fill surface pits. Metallized surfaces also improve adhesion and allow the junction 104 to be inductively heated. In another example, the junction 104 may be coated with an inorganic material, such as silicon oxide (glass or glass-like), or with an organometallic material. A silane coupling agent can be applied to the surface to alter the surface hydrophobicity. If metal, the junction 104 may be electropolished to improve surface roughness. The junction may be further polished using a paste abrasive, such as one available from Extrude Hone LLC, Pennsylvania.

[0025] With reference to FIG. 2 , junction 104 can be described as having an upstream portion 106 and a downstream portion 108. In this example, fluid is assumed to flow from left to right across FIG. 2 , as indicated by arrow F. As noted above, junction 104 can be used with fluids flowing in the opposite direction. Thus, the terms upstream and downstream apply to portions 106, 108 only by way of example and may be reversed. Junction 104 provides multiple fluid pathways 110 between upstream portion 106 and downstream portion 108. Preferably, at least a portion of each pathway 110 is a curved segment 112. A curved segment is a segment that deviates from a straight line without sharp breaks or corners. The curvature preferably allows progression from a small area (i.e., the end of a multi-lumen or single-lumen conduit) to multiple independent conduits that necessarily occupy more space. To connect extremes in surface area, the shortest, smoothest path between them is considered to be a curved path. Curved paths have not previously been used because they are difficult or impossible to manufacture with conventional molding or machining processes.

[0026] 1-7 includes eight fluid paths 110, however, any other suitable number of fluid paths, such as four, five, six, seven, nine, ten, or more fluid paths, may be used without departing from the scope of this disclosure. The fluid paths 110 within the junction 104 share a common path segment 114. For fluid flowing in direction F, the fluid paths 110 may be described as joining at the common path segment 114. When the flow is reversed, the fluid from the common path segment 114 may be described as splitting to produce the eight illustrated fluid paths 110.

[0027] In embodiments where the junction 104 is a unitary structure, the junction itself may not include additional components. For example, the multiple fluid paths 110 from the upstream portion to the downstream portion may not include diaphragms that can restrict or stop flow. In other words, valves may not be incorporated into the junction to control fluid flow.

[0028] 1-7 includes eight openings 116 on the upstream portion 106 corresponding to eight fluid paths 110 and one opening 116 on the downstream portion 108 because all of the illustrated fluid paths 110 join a single common path segment 114 that leads to openings 116 on the downstream portion of the junction. Thus, in embodiments including a common path segment 114, the number of openings 116 on the upstream portion 106 may not correspond to the number of openings on the downstream portion 108. In some embodiments not shown, the common path segment 114 may include an intermediate mixing chamber having an equal number of separate path segments extending upstream and downstream.

[0029] Referring to FIG. 2 , the fluid conduits 102 are attached to, and preferably sealed to, the junction 104 to place one or more lumens 120 of the fluid conduits 102 in fluid communication with the respective fluid pathways 110. Preferably, the junction 104 includes a male insert 122 corresponding to each lumen 120 of each fluid conduit 102. The male inserts 122 are configured to be inserted into their respective lumens 120. According to the embodiment of FIG. 2 , the male inserts 122 on the upstream portion 106 of the junction 104 include a cylindrical tubular structure. In the illustrated embodiment, the multiple male inserts 122 are substantially parallel to one another. As shown in the downstream portion 108, the male inserts 122 may include one or more barbs 124 or teeth. In FIGS. 1-7 , the junction 104 is shown attached to each lumen 120 of each conduit 102 using the male inserts 122. In some embodiments, the junction 104 may include a female attachment portion that surrounds the exterior of one or more conduits 102. In other embodiments, the male insert 122 can be configured to abut the end of the conduit instead of being inserted into the conduit. For example, the insert 122 can terminate in a flange suitable for use with a tri-clamp, as is well known in the bioprocessing equipment art. If a tri-clamp is used, the clamp connection can comply with ASME-BPE 2016.

[0030] 2 and 3, the plurality of male inserts 122 in the upstream portion of the junction 104 are surrounded by a peripheral wall 128, also referred to as a flange or skirt. The peripheral wall 128 forms a cavity 130 consisting of the interstitial space between the male inserts 122. In one embodiment, the peripheral wall 128 is scalloped to closely follow the contours of the plurality of fluid conduits 102 attached to the corresponding portion of the junction 104.

[0031] In some embodiments, the peripheral wall 128 is configured to accommodate an adhesive or curable material used to secure the fluid conduit 102 to the junction 104. In one embodiment, a silicone adhesive (LIM8040) can be placed within the peripheral wall 128 of the junction 104, and then the multi-lumen silicone conduit 102 can be placed within the cavity. In one variation, the adhesive can be heat-cured at about 150°C for about 30 minutes, although other temperatures (e.g., about 140°C to about 160°C, or other numbers therebetween) and durations (e.g., about 20 to about 40 minutes, or other suitable times therebetween) can be used without departing from the scope of the present disclosure. In some embodiments, the curable material can provide a cast seal. When used, the cast seal surrounds the conduit 102 and secures it to the junction 104. In one embodiment, the cast seal is comprised of a self-leveling, pourable silicone, such as room-temperature-vulcanizing (RTV) silicone. RTV silicones may be two-component systems (base plus curing agent) ranging in hardness from relatively soft to medium hardness, such as from about 9 Shore A to about 56 Shore A. Suitable RTV silicones include Wacker® Elastosil® RT 622 (available from Wacker Chemie AG), a pourable, addition-cure, two-component silicone rubber that vulcanizes at room temperature, and Rhodorsil® RTV 1556 (available from Blue Star Silicones), a two-component, high-strength, addition-cure, room-temperature or heat-vulcanizing silicone rubber compound. Both Wacker® Elastosil® RT 622 and Bluestar Silicones Rhodorsil® RTV 1556 have viscosities of about 12,000 cP (mPa.s). The above silicones and their equivalents offer low viscosity, high tear resistance, high temperature and chemical resistance, excellent flexibility, low shrinkage, and the ability to cure cast silicone seals at temperatures as low as about 75° F. Cast seals can also be constructed from dimethyl silicone, low temperature diphenyl silicone, or methyl phenyl silicone.An example of a phenyl silicone is Nusil MED 6010, which is particularly suitable for low-temperature applications. In another embodiment, the casting agent is a perfluoropolyether liquid. A preferred perfluoropolyether liquid is Sifer 2167, available from Shin-Etsu Chemical Co., Ltd. of Tokyo, Japan. In some cases, a primer may be used to promote bonding of the mold seal to the conduit 102 and junction 104. Suitable primers are SS-4155, available from Momentive®, Med-162, available from NuSil Technology, and Rodorsil® V-O6C, available from Bluestar Silicones of Lyon, France.

[0032] The conduit 102 may be secured to the junction 104, such as by being secured around the male insert 122, using one or more of several other known attachment techniques. For example, the conduit 102 shown attached to the male insert 122 on the downstream portion 108 of the junction 104 may be held by friction and supplemented by barbs shown on the male insert. Additionally or alternatively, several clamping methods are known in the art, including Oetiker clamps, hose clamps, cable ties, and the like. The conduit 102 may also be welded to the junction 104. In some embodiments, the junction 104 may be formed with a receiver for the conduit 102 to facilitate quick connect installation, similar to the MPC series fittings by Colder Products Company, Inc., of St. Paul, Minnesota.

[0033] Figures 8-15 illustrate a fluid transfer assembly 200 having fluid conduits 202 and a junction 204. As shown in Figures 8-9, one of the fluid conduits 202 is a multi-lumen conduit. The illustrated multi-lumen conduit has a central lumen sealingly joined to the junction 204 and configured for fluid communication with a fluid pathway 210. The junction 204 is substantially similar to the junction 104 shown in Figures 1-7, but is comprised of a central fluid pathway 210 and seven peripheral fluid pathways to correspond to the arrangement of lumens 220 through the multi-lumen conduit. The central fluid pathway 210 does not have a curved segment 212, while the peripherally disposed fluid pathways do. Instead of barb fittings as shown in Figure 2, the junction 204 includes a peripheral wall 228 surrounding a plurality of male inserts 222 at each of the upstream and downstream portions 206, 208 of the junction.

[0034] FIG. 16 illustrates a third fluid transfer assembly 300. The fluid transfer assembly 300 includes a junction 304 sealingly attached to the ends of a plurality of conduits 302, which are themselves coupled to the junctions 104 or 204 as described above. FIGS. 17-21 include a perspective view, a top view, a bottom view, a major side view, and a minor side view of the junction 304, respectively. Unlike the junctions 104, 204 of the first and second embodiments, the third embodiment of the junction 304 includes multiple fluid paths 310, each with a curved segment 312, but each path terminates in a nozzle 334, thereby forming a predetermined upstream portion 306 and downstream portion 308 for the junction 304.

[0035] Figure 22 shows a fourth fluid transfer assembly 400. The fluid transfer assembly 400 includes a plurality of fluid conduits 402, including a multi-lumen conduit at one end of a junction 404 and a plurality of single-lumen conduits arranged radially around the central axis of the junction. Figures 23-29 show various views of the junction 404. The junction 404 includes a plurality of male inserts 422 on the upstream portion 406 and a plurality of male inserts 422 on the downstream portion 408. The male inserts 422 on the downstream portion are arranged radially and are shown in the form of barb fittings.

[0036] The junction 404 includes an optional marker 440 adjacent one of the male inserts 422 that corresponds to a fluid pathway 410 accessible along the central axis of the junction 404. While the marker 440 is illustrated as an oval boss, the marker may be any marker capable of providing a user with an indication of which male insert 122 corresponds to the central one of the male inserts 422 on the upstream portion 406. Because the pathways 410 corresponding to the circumferentially disposed inserts 422 of the upstream portion 406 may be apparent to a user, only a single marker 440 for a single insert 422 may be necessary. However, in other embodiments, each pathway 410 may be labeled.

[0037] Junctions according to the various embodiments described above, particularly junctions 104, 204, and 404, are shown in cross-section in FIGS. 2, 10, and 23 as being substantially solid. However, by utilizing additive manufacturing techniques, junctions (e.g., 104, 204, and 404) can be formed to have one or more hollow cavities 450 ( FIG. 30 ) that are independent of, i.e., not in fluid communication with, the plurality of fluid paths 410. The inventors have determined that additive manufacturing provides an opportunity to construct the fluid paths 410 of the junction 404 and the walls of the shell 454 without necessarily filling the remainder of the shell 454 with material. By forming one or more hollow cavities 450 within the junction 404, the cost of manufacturing the junction can be reduced because material costs are reduced as less material is used. Additionally, depositing less material allows for shorter manufacturing times. This again reduces the cost of manufacturing the junction.

[0038] 31-36 illustrate a junction 504 according to a fifth embodiment. The junction 504 includes a generally circular peripheral wall 528 instead of a scalloped peripheral wall, but is otherwise substantially similar to the junction 104 of the first embodiment (FIGS. 1-7). FIG. 36 illustrates the junction 504 as being substantially solid in areas other than the fluid path 510. In other embodiments, a hollow cavity may be integrated into the junction 504.

[0039] 37-43 show a junction 604 according to a sixth embodiment. The junction 604 is particularly suitable for mounting adjacent to or directly on the opening of a flexible polymer container, such as a bioreactor bag. The junction 604 of the illustrated embodiment integrates three fluid paths 610 in a fixed orientation, helping to maintain the conduits in an organized manner. If a reducer is provided at the distal end of the junction 604 out of the plane of the fluid paths, the packaging space can be reduced and the number of junctions can be minimized.

[0040] 44-47 show perspective and cross-sectional views of a junction 704 according to a seventh embodiment. As shown in FIGS. 44-47, the junction 704 generally includes a body 705 having an upstream portion 706 and a downstream portion 708 (e.g., fluid may flow from left to right across FIG. 46). However, the junction 704 may also be used with fluid flowing in the opposite direction, and thus the terms upstream and downstream as applied to portions 706, 708 are used by way of example only and may be used vice versa.

[0041] Junction 704 further includes a plurality of fluid pathways 710 defined through junction body 705 between upstream portion 706 and downstream portion 708, with each fluid pathway 710 generally including at least one curved segment 712 ( FIG. 46 ). In the illustrated embodiment, junction 704 of FIGS. 44-46 includes five fluid pathways 710, although any suitable number of fluid pathways (e.g., less than five, e.g., three or four fluid pathways, or more than five, e.g., six, seven, eight, or more fluid pathways) may be used without departing from the scope of the present disclosure.

[0042] 44-46 also includes five openings 716 on the upstream portion 706 and five openings 718 on the downstream portion 708 corresponding to the five fluid paths 710. Each fluid path 710 extends between a corresponding opening 716 on the upstream portion 706 and a corresponding opening 718 on the downstream portion 708, placing the openings 716 / 718 in fluid communication with one another (e.g., allowing fluid flow into opening 716 and out of opening 718, or allowing fluid flow into opening 718 and out of opening 716).

[0043] As shown in FIGS. 45, 46, and 47, the downstream portion 708 of the junction 704 further includes a plurality of male inserts 722 configured to be attached or coupled to the fluid conduit 102 to fluidly connect one or more lumens 120 of the fluid conduit 102 to a respective fluid pathway 710. For example, each male insert 722 includes at least a portion of a fluid pathway and includes an opening 718 defined therein. The male inserts 722 are configured to be inserted into their respective lumens 120 and generally include a cylindrical tubular structure, although other suitable shapes, configurations, etc. are possible without departing from the scope of the present disclosure. The plurality of male inserts 722 may also be substantially parallel to one another. While the embodiment shown in FIGS. 44-47 shows male inserts 722, other suitable attachment assemblies, such as female attachments or connectors (e.g., that at least partially surround and engage the exterior of the fluid conduit 102) for fluidly coupling the fluid conduit 102 to the fluid pathway 710, may be used without departing from the scope of the present disclosure.

[0044] The plurality of male inserts 722 on the downstream portion 708 of the junction 704 are surrounded by a peripheral wall 728, also referred to as a flange or skirt. The peripheral wall 728 forms a cavity 730 consisting of interstitial spaces between the male inserts 722. In one embodiment, the peripheral wall 728 is scalloped to roughly follow the contours of the plurality of fluid conduits 102 attached to corresponding portions of the junction 704. The plurality of fluid conduits 102 may engage at least a portion of the peripheral wall 728 when connected to the male inserts 722, for example, to facilitate a mating connection between the conduits and the junction, although the fluid conduits 102 may be spaced apart (i.e., not engaged) from the peripheral wall 728 when connected to the male inserts 722.

[0045] 44-47 further show that the upstream portion 706 of the junction 704 includes a connection assembly 750 for connecting the junction 704 to a barbed connector 752 of a fluid containment vessel 754 (e.g., a fluid containment vessel, including a flexible vessel such as a bag, rigid container, or other suitable vessel for receiving and storing a fluid). The barbed connector 752 may include a cylindrical body 756 defining a lumen or fluid pathway 758 that communicates with a chamber 760 of the fluid containment vessel 754. The connection assembly 750 further includes a stem or post 762 (e.g., having a substantially cylindrical configuration, although other configurations are possible) configured to be received within the lumen 758 of the barbed connector body 756, as generally shown in FIG.

[0046] The stem or post 762 further includes a plurality of O-ring seats 764 / 766 defined therealong (FIGS. 44, 46, and 47). The O-ring seats 764 / 766 are configured to receive O-rings or other suitable sealing members, such as a first O-ring 768 and a second O-ring 770 (FIG. 47). With the stem 762 received within the lumen 758 of the barbed connector body 756, the first O-ring 768 engages the interior of the lumen 758 to form a primary seal (e.g., substantially seal) between the barbed connector 752 and the junction 704. Furthermore, with the stem 762 received within the lumen 758, the second O-ring 770 engages the end 756A of the barbed connector body 756 to form an additional or secondary seal between the barbed connector 752 and the junction 704. The secondary seal formed by the second O-ring 770 helps to maintain a substantial seal between the barbed connector 752 and the junction 704, for example, in the event of failure, leakage, etc. of the first O-ring 768.

[0047] Further, as generally shown in FIGS. 44, 46, and 47, at least a portion of the flow path 710 is defined through the stem 762. The opening 716 in the upstream portion 706 is further defined along the end 762A of the stem 762. In one embodiment, the end 762A of the stem 762 can have a generally dome-shaped, hemispherical, or arcuate configuration, and the opening 716 can be formed along a curved outer surface or face 772 of the end 762A. However, the end 762A of the stem 762 can have any suitable shape, structure, configuration, etc. (e.g., a substantially flat end 862A as shown in FIGS. 49, 51, and 52) without departing from the scope of the present disclosure.

[0048] The connection assembly 750 further includes a peripheral wall 774, also referred to as a flange or skirt, that surrounds the stem 762 and is configured to facilitate connection between the junction 704 and the barbed connector 752. In one embodiment, as shown in FIGS. 47 and 48 , the connection assembly 750 includes a fitting or adapter 776 that engages the peripheral wall 774 and the barbed connector body 756 to facilitate attachment / connection between the junction 704 and the barbed connector 752. The fitting 776 includes a body 778 (e.g., having a generally cylindrical configuration) and a plurality of locking features 780 (e.g., protruding portions or other suitable members / bodies having a generally cylindrical configuration) extending from the fitting body 778. The fitting body 778 further includes a passageway 779 formed therethrough that is sized, shaped, configured, etc. to receive at least a portion of the barbed connector body 756. Thus, the fitting 776 may be received about the barbed connector body 756 such that the end 778A of the fitting body 778 engages the surface or face 782A defined by the barb 782 of the barbed connector 752. The peripheral wall 774 may further be received about the fitting 776 and the barbed connector body 752 such that at least a portion of the locking feature 780 (e.g., end 780A) engages a lip or shoulder 784 defined along the peripheral wall 774 to compress or engage the second O-ring 770 against the end 756A of the barbed connector body 756.

[0049] Figures 49-52 show perspective and cross-sectional views of a junction 804 according to an eighth embodiment. The junction 804 is substantially similar to the junction 704 shown in Figures 44-47, except that the end 862A of the stem 862 is generally flat (e.g., with the opening 816 disposed on a generally flat surface 872), and the peripheral wall 774 and fitting 776 are omitted. As shown in Figures 49-52, the upstream portion 806 of the junction 804 instead includes a plurality of locking features 890 configured to facilitate attachment between the barbed connector 752 and the junction 804. The locking features 890 may include a plurality of spaced apart portions or bodies 892 having tabs, protrusions, or the like 894 defined therealong and configured to engage the barbs 782 of the barbed connector 752. For example, locking feature 890 can be biased inward to engage tab 894 with barb 782 and / or to engage tab 894 with barbed connector body 756. Thus, to attach / couple junction 804 to barbed connector 752, locking feature 890 can be received around barbed connector body 756 until tab 894 and barb 782 lock into position to press or engage O-ring 870 against end 756A of barbed connector body 756.

[0050] FIG. 53 shows a side view of a junction 904 according to a ninth embodiment of the present disclosure. As shown in FIG. 53, the junction 904 can include multiple fluid paths 910 that communicate with a common fluid path 914. In the illustrated embodiment, the junction 904 can include six fluid paths 910 that communicate with the common fluid path 914; however, any suitable number of fluid paths, such as two, three, four, five, seven, eight, or more fluid paths, can be used without departing from the scope of the present disclosure. One set of fluid paths 910 can include curved segments or portions 912, where a curved segment is one that deviates from a straight line without a sharp break or bend. For example, the fluid paths at the end of the junction 904 can include curved segments or portions 912. Another set of fluid paths 910 can be substantially straight (i.e., without curved segments or portions). For example, the fluid paths 910 between the fluid paths 910 at the ends of the junctions 904 may be substantially straight, e.g., without curved segments or portions, although the fluid paths between the ends of the fluid paths at the ends of the junctions 904 may include one or more curved segments.

[0051] 53 further illustrates that the junction 904 includes a plurality of male inserts 922 configured to be attached or coupled to the fluid conduit 102 to place one or more lumens 120 of the fluid conduit 102 in fluid communication with the respective fluid pathways 910. For example, each male insert 922 includes at least a portion of the fluid pathway 910 and includes an opening 918 defined therein. The male inserts 922 are configured to be inserted into the respective lumens 120 and generally comprise a cylindrical, tubular structure. In the illustrated embodiment, the plurality of male inserts 922 are substantially parallel to one another. The male inserts 922 may further include one or more barbs or teeth 924 to facilitate connection / attachment to the fluid conduit 102. In the illustrated embodiment, a male insert 922 is shown, however, other suitable attachment assemblies, such as a female attachment or connector (e.g., at least partially surrounding and engaging the exterior of the fluid conduit 102) for fluidly coupling the fluid conduit 102 to the fluid path 910, may be used without departing from the scope of the present disclosure.

[0052] FIG. 54 illustrates a sterile fluid transfer assembly 1000 according to one embodiment of the present disclosure. The fluid transfer assembly 1000 includes multiple fluid conduits 102 attached to a junction (e.g., junction 704 as shown in FIGS. 44-47 , but also other suitable junctions described herein, such as junction 804 shown in FIGS. 49-52 ), and can be used without departing from the scope of the present disclosure. The fluid conduits 102 are attached to a downstream portion 708 of the junction 704. The fluid conduits 102 may be attached to, lead from, or to one or more containers 1006, including, but not limited to, vessels, beakers, bottles, canisters, flasks, bags, receptacles, tanks, vats, vials, tubing, syringes, carboys, tanks, pipes, and the like, commonly used to contain liquids, slurries, and other similar substances. Additionally, the upstream portion 706 of the junction 704 may be coupled to a barbed connector 752 of an additional container 1008. In one embodiment, the additional container 1008 can include a bag or other suitable flexible container for containing liquids, slurries, and other similar substances, although the additional container 1008 can include a rigid container such as a bottle, flask, beaker, or other rigid container without departing from the scope of this disclosure. The barbed connector 752 can be secured to the additional container 1008 by heat sealing or other suitable attachment method. The additional container 1008 generally has a volume substantially larger than the volume of one or more of the containers 1006, although the container 1008 can have a volume smaller than the volume of one or more of the containers 1006 without departing from the scope of this disclosure. One or more of the containers 1006 (or containers 1008) can further include one or more valves in communication therewith, which can be actuated, e.g., opened or closed, to initiate the transfer of fluids to and from the container 1006 (or container 1008). For example, fluid flow may be initiated (e.g., when a valve is opened) due to a pressure difference between vessel 1006 and vessel 1008 (e.g., due to a volume difference between vessels (1006 / 1008)).The container 1006 may further include a syringe or other mechanism for drawing fluid from the container 1008 .

[0053] 54 can be used to transfer liquids, slurries, and other similar substances (e.g., provided in container 1008 or one or more containers 1006) between one or more containers 1006 and container 1008 via junction 704. In one embodiment, fluid from container 1008 can flow into opening 716 in upstream portion 706 of junction 704, through fluid path 710, and into opening 718 in downstream portion 708 of junction 704. The fluid can then flow out opening 718 in downstream portion 708 into fluid conduit 102 and through fluid conduit 102 into one or more containers 1006. For example, a fluid sample can be transferred from container 1008 to one or more containers 1006 for sterility testing, cell viability testing, or other suitable testing of a biological sample.

[0054] In additional or alternative embodiments, fluid may be transferred from one or more containers 1006 to container 1008 (e.g., an acid or base may be provided to container 1008 from one or more containers 1006, an antifoaming agent may be provided to container 1008 from one or more containers 1006 to reduce foaming therein, small packages of cells may be provided to container 1008 from one or more containers 1006 to promote cell growth therein, or other suitable fluid may be provided or otherwise introduced to container 1008 from one or more containers 1006 to inoculate container 1008, etc.). For example, fluid may flow from one or more containers 1006 into fluid conduit 102, from which it flows into opening 718 in downstream portion 708 of junction 704. The fluid then flows through fluid path 710 in junction 704 to opening 716 in upstream portion 706 of junction 704, and out opening 716 into container 1008.

[0055] Returning again to the embodiment shown in FIGS. 44-47, the opening 716 in the upstream portion 706 of the junction 704 can have a diameter that is substantially smaller than the diameter of the opening 718 in the downstream portion 708 of the junction 704. For example, the opening 716 can have a diameter ranging from about 0.05 mm to about 5.0 mm, e.g., about 0.06 mm, about 0.07 mm, about 0.08 mm, about 0.1 mm, about 0.12 mm, about 0.13 mm, about 0.14 mm, about 0.15 mm, about 0.16 mm, about 0.17 mm, about 0.18 mm, about 0.19 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, about 2.0 mm, about 3.0 mm, about 4.0 mm, or other suitable values, although diameters smaller than 0.05 mm and greater than 5 mm can be used without departing from the scope of the present disclosure. Alternatively, the opening 718 can have a diameter ranging from about 5 mm to about 20 mm, e.g., about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or other suitable values ​​therebetween, although diameters less than 5 mm and greater than 20 mm can also be used without departing from the scope of the present disclosure. The opening 716 is generally sized, dimensioned, configured, etc., to allow liquids, slurries, and other similar substances of appropriate viscosity to flow into or out of the opening 716 through the junction 704, and further, the opening 716 may generally be sized, dimensioned, configured, etc., to help substantially prevent, reduce, or inhibit backflow or return flow from the fluid path 710, such as when the sealable portion 1010 of the fluid conduit (FIG. 54) is clamped, crimped, or closed to seal the conduit 102, or when the conduit 102 is otherwise closed.The sealable portion can include a Quickseal® portion available from Sartorius Stedim North America, examples of which are shown and described in commonly owned U.S. Patent No. 8,505,586, which is incorporated herein by reference as if set forth in its entirety. The openings 816 and 818 of junction 804 shown in Figures 49-52 can also have a similar structure (e.g., the same structure) as the openings 716 and 718 of junction 704 shown in Figures 44-47.

[0056] A method of manufacturing / assembling a fluid transfer assembly may include securing the barbed connector 752 to the container 1008 (e.g., if the container 1008 includes a bag, the barbed connector 752 may be secured to the bag by heat sealing the barbed connector 752 to the bag). The method may further include attaching a junction according to an embodiment described herein, such as junction 704, junction 804, or other suitable junction described herein, to the barbed connector 752; for example, the upstream portion 706 / 806 of junction 704 / 804 may be attached to the barbed connector 752 as described above. Additionally, the conduit 102 may be attached to the downstream portion 708 / 808 of junction 704 / 804 as described above. For example, the method may include inserting at least one of a plurality of male inserts 722 / 822 into the lumen 120 of the flexible fluid conduit 102 to secure the flexible fluid conduit to the junction. The conduit 102 can further be attached to one or more containers 1006. Upon assembly of the fluid transfer assembly (e.g., upon connection of the container 1008, junction 704 / 804, conduit 102, and one or more containers 1006), the fluid transfer assembly can be packaged in a single polyethylene bag, multiple polyethylene bags, or other suitable packaging, such as a thermoformed tray with a removable lid or other suitable container, to form, for example, a packaged assembly. After packaging the fluid transfer assembly, the packaged assembly can be rendered substantially sterilized, for example, by applying gamma radiation, as described below. However, it will be understood that the above steps are not limited to any particular order or sequence, and one or more of the above steps can be rearranged, omitted, or additional steps added without departing from the scope of the present disclosure. For example, the assembly can be rendered substantially sterilized prior to packaging, and / or one or more conduits and their corresponding containers can be attached to the junctions prior to attachment of the junctions and barbed connectors.

[0057] To conserve space and minimize the use of separate components, junctions 104, 204, 304, 404, 504, 604, 704, 804, and 904 of the present disclosure each have at least one fluid path through the junction that includes a nonlinear, preferably curved, segment. As noted above, implementing the preferred path for each fluid path is difficult or simply not feasible using conventional injection molding or boring techniques.

[0058] Thus, in some embodiments, a method of manufacturing / assembling a fluid transfer assembly according to the present disclosure includes depositing successive layers of material using an additive manufacturing device (e.g., a 3D printer) to form a single junction having an upstream portion and a downstream portion, the single junction defining multiple curved fluid paths between the upstream portion and the downstream portion. Alternatively, the junction can be formed using CLIP technology, such as that offered by Carbon, Inc., which uses, for example, digital light compositing, a pattern of light to partially cure product layers, layer by layer, such that as a body of cured or semi-cured material is lifted from a reservoir of uncured material, the uncured material is cured to the bottom of the stack. In some embodiments, at least one of the upstream portion and the downstream portion includes multiple male inserts, each corresponding to a multiple of the fluid paths.

[0059] During the step of depositing successive layers of material, the act of depositing the material may form at least one hollow cavity within the junction sealed from the plurality of fluid paths. The method also includes inserting a plurality of male inserts into the lumen of the flexible fluid conduit and securing the flexible fluid conduit to the junction. In one embodiment, securing the flexible fluid conduit to the junction includes overmolding the conduit onto the junction.

[0060] The method of manufacturing / assembling the fluid transfer assembly may further include rendering the fluid transfer assembly substantially sterilized, for example, by gamma radiation. Alternatively, the entire fluid transfer assembly or its components may be rendered substantially sterilized by exposure to steam above 121°C for a time sufficient to eliminate microorganisms. The entire assembly or its components may also be rendered sterilized by chemical treatment, such as ethylene oxide (ETO). Once rendered substantially sterilized, the fluid transfer assembly may be suitably packaged and stored to maintain its substantially sterility until ready for use.

[0061] The foregoing description generally illustrates and describes various embodiments of the present disclosure. However, it will be understood by those skilled in the art that various changes and modifications can be made to the above-described configurations and systems without departing from the spirit and scope of the present disclosure as set forth herein, and that all matter contained in the above description or shown in the accompanying drawings is intended to be interpreted as illustrative and not limiting. Furthermore, the scope of the present disclosure is to be construed as including, in addition to the above-described embodiments, the various modifications, combinations, additions, alterations, and the like, which are considered to be within the scope of the present disclosure. Thus, the various features and properties described herein may be selectively interchanged and applied to other illustrated and non-illustrated embodiments, and numerous variations, modifications, and additions may still be made without departing from the spirit and scope of the present invention as set forth in the appended claims.

Claims

1. a single junction having an upstream portion and a downstream portion, the single junction defining a plurality of curved fluid paths between the upstream portion and the downstream portion, each of the curved fluid paths defining a central axis along its length, the central axis comprising a straight first segment, a curved second segment, and a straight third segment, the second segment being disposed between the first and third segments, the second segment of the central axis deviating from a straight line to define a smooth curve; a plurality of flexible fluid conduits sealed to the single junction at one of the upstream portion or the downstream portion so as to be in fluid communication with the plurality of curved fluid paths; the plurality of flexible fluid conduits are connected to a plurality of first containers; the plurality of curved fluid paths are in fluid communication with a second container via the other of the upstream portion or the downstream portion; fluid is transferred between the plurality of first containers and the second container through the single junction; the single junction is manufactured using an additive manufacturing process, such that the upstream portion, the downstream portion, and the plurality of curved fluid paths of the single junction are a single, seamless, integral structure; Fluid transfer assembly.

2. The fluid transfer assembly of claim 1 , wherein the single junction is formed from multiple layers of material.

3. 3. The fluid transfer assembly of claim 2, wherein each of said plurality of layers of material is of approximately the same thickness.

4. 2. The fluid transfer assembly of claim 1, wherein said one of said upstream portion and said downstream portion comprises a plurality of male inserts respectively corresponding to said plurality of curved fluid paths, said plurality of male inserts being inserted into said plurality of flexible fluid conduits to facilitate fluid communication therebetween.

5. The fluid transfer assembly of claim 4 , wherein the single junction comprises a peripheral wall surrounding the plurality of male inserts.

6. 6. The fluid transfer assembly of claim 5, wherein a hardenable material is contained by said peripheral wall and attaches said plurality of flexible fluid conduits to said single junction.

7. The fluid transfer assembly of claim 5 wherein said peripheral wall is scalloped.

8. 5. The fluid transfer assembly of claim 4, wherein said plurality of flexible fluid conduits includes a plurality of lumens equal to said plurality of male inserts such that each of said plurality of male inserts engages a respective lumen of said plurality of flexible fluid conduits.

9. 5. The fluid transfer assembly of claim 4, wherein said male inserts are substantially parallel to one another.

10. 5. The fluid transfer assembly of claim 4, wherein said plurality of male inserts are radially arranged about a central axis of said single junction.

11. The other of the upstream portion and the downstream portion comprises a plurality of other male inserts respectively corresponding to the plurality of curved fluid paths; the plurality of other male inserts are disposed at and around the center of the single junction; 11. The fluid transfer assembly of claim 10, wherein the single junction includes a marking adjacent to one male insert of the plurality of male inserts, the one male insert corresponding to a central insert of the other male insert of the plurality.

12. The fluid transfer assembly of claim 1 , wherein the single junction includes a common path portion that provides a portion of at least two of the plurality of curved fluid paths.

13. 13. The fluid transfer assembly of claim 12, wherein the common path portions are arranged such that the number of openings in the downstream portion is not equal to the number of openings in the upstream portion.

14. 10. The fluid transfer assembly of claim 1, wherein the plurality of curved fluid paths from the upstream portion to the downstream portion do not have diaphragms capable of restricting or stopping flow.

15. The fluid transfer assembly of claim 1 , wherein the single junction comprises a hollow cavity separate from the plurality of curved fluid paths.

16. 10. The fluid transfer assembly of claim 1, further comprising at least one additional component including at least one of a container, a fitting, and a connector.

17. 2. The fluid transfer assembly of claim 1, wherein the upstream portion includes a connection assembly for coupling the single junction to a barbed connector of the first container, the connection assembly including a stem and a peripheral wall at least partially surrounding the stem to facilitate attachment of the single junction to the barbed connector.

18. 18. The fluid transfer assembly of claim 17, wherein the connection assembly includes a fitting for engaging the barbed connector and the peripheral wall, the fitting including a body having a plurality of locking features extending from the body and configured to engage at least a portion of the single junction.

19. 20. The fluid transfer assembly of claim 18, wherein the single junction is formed by digital light synthesis using a pattern of light that at least partially cures the single junction layer by layer such that uncured material is cured to the bottom of the stack as a body of cured or semi-cured material is lifted from a reservoir of uncured material.

20. a single junction having an upstream portion and a downstream portion, the single junction including walls defining a plurality of curved fluid paths between the upstream portion and the downstream portion, each of the curved fluid paths defining a central axis, the walls defining each of the curved fluid paths comprising a first straight section, a second curved section, and a third straight section, the second section being disposed between the first section and the third section, the second section defining a segment of the central axis having a smooth curve along a length of the central axis; a plurality of flexible fluid conduits sealed to the single junction at one of the upstream portion or the downstream portion so as to be in fluid communication with the plurality of curved fluid paths; a plurality of containers connected to the plurality of flexible fluid conduits; the one of the upstream portion or the downstream portion comprising a plurality of male inserts respectively corresponding to the plurality of curved fluid paths, the plurality of male inserts being inserted into the plurality of flexible fluid conduits to facilitate fluid communication therebetween; the single junction is manufactured using an additive manufacturing process, such that the upstream portion, the downstream portion, and the plurality of curved fluid paths of the single junction are a single, seamless, integral structure; Fluid transfer assembly.

21. 21. The fluid transfer assembly of claim 20, wherein the plurality of containers comprises bags, beakers, bottles, canisters, flasks, tanks, vats, vials, tubes, syringes, or combinations thereof.

22. 21. The fluid transfer assembly of claim 20, wherein the single junction is formed from multiple layers of material, each layer being approximately the same thickness.

23. 21. The fluid transfer assembly of claim 20, wherein the single junction includes a hollow cavity separate from the plurality of curved fluid paths.

24. the single junction includes a common path portion that forms part of at least two of the plurality of curved fluid paths; the common path portion is arranged such that the number of access points in the downstream portion is not equal to the number of access points in the upstream portion; 21. The fluid transfer assembly of claim 20.

25. the single junction includes a peripheral wall surrounding the plurality of male inserts; a hardenable material contained by the peripheral wall and attaching the plurality of flexible fluid conduits to the single junction; 21. The fluid transfer assembly of claim 20.

26. 21. The fluid transfer assembly of claim 20, wherein the plurality of flexible fluid conduits comprises a plurality of lumens equal to the plurality of male inserts such that each of the plurality of male inserts engages a respective lumen of the plurality of flexible fluid conduits.

27. 21. The fluid transfer assembly of claim 20, wherein the male inserts are substantially parallel to one another.

28. 21. The fluid transfer assembly of claim 20, wherein the plurality of male inserts are radially arranged about a central axis of the single junction.

29. The other of the upstream portion and the downstream portion comprises a plurality of other male inserts respectively corresponding to the plurality of curved fluid paths; the plurality of other male inserts are disposed at and around the center of the single junction; 29. The fluid transfer assembly of claim 28, wherein the single junction includes a mark adjacent to one male insert of the plurality of male inserts, the one male insert corresponding to a central insert of the other male insert of the plurality.

30. forming successive layers of material using an additive manufacturing apparatus to form a single junction having an upstream portion and a downstream portion, the single junction defining a plurality of curved fluid paths between the upstream portion and the downstream portion, each of the plurality of curved fluid paths defining a central axis, the central axis comprising a straight first segment, a curved second segment, and a straight third segment, the second segment being disposed between the first segment and the third segment, the second segment of the central axis deviating from a straight line to define a smooth curve, and one of the upstream portion or the downstream portion including a plurality of male inserts corresponding respectively to the plurality of curved fluid paths; inserting the plurality of male inserts into the lumens of a plurality of flexible fluid conduits; securing the plurality of flexible fluid conduits to the single junction; Including, the plurality of flexible fluid conduits are connected to a plurality of containers; the single junction is manufactured using an additive manufacturing process, such that the upstream portion, the downstream portion, and the plurality of curved fluid paths of the single junction are a single, seamless, integral structure; A method for manufacturing a fluid transfer assembly.

31. 31. The method of claim 30, wherein said forming step includes forming a hollow cavity in said single junction that is sealed from said plurality of curved fluid paths.

32. 31. The method of claim 30, wherein the step of securing the flexible fluid conduit to the unitary junction comprises overmolding the flexible fluid conduit to the unitary junction.

33. further comprising the steps of rendering the single junction and the flexible fluid conduit substantially sterile; packaging the single junction and the flexible fluid conduit to maintain substantial sterility until ready for use; 31. The method of manufacturing a fluid transfer assembly of claim 30, comprising:

34. 31. The method of manufacturing a fluid transfer assembly of claim 30, further comprising treating an exterior surface of the single junction.

35. 1. A method for fluid transfer through a single junction, comprising: providing a fluid to a first container connected to an upstream portion of the single junction, the upstream portion having a connection assembly for engaging a connector of the first container; transporting the fluid through a plurality of curved fluid paths defined through the single junction, each of the plurality of curved fluid paths defining a central axis, the central axis comprising a first straight segment, a second curved segment, and a third straight segment, the second segment being disposed between the first and third segments, and the second segment of the central axis deviating from a straight line to define a smooth curve; receiving fluid in a plurality of second vessels in communication with a downstream end of the single junction via a plurality of flexible fluid conduits connected to the plurality of curved fluid paths; Including, the single junction is manufactured using an additive manufacturing process, such that the upstream portion, the downstream end, and the plurality of curved fluid paths of the single junction are a single, seamless, monolithic body; A method for fluid transport through a single junction.

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