Tube assembly

Abstract

This tube assembly comprises at least one set of three components: a flexible tube through which a fluid flows; a connector having an insertion section to be inserted into the end portion of the tube and at least one large-diameter section provided on a part of the insertion section and protruding radially; and a fastener that is provided at one location at the end portion when the insertion section is inserted, between the end face of the end portion and the large-diameter section located closest to the end face, and fastens the end portion from the outside to fix the connector to the tube, wherein the axial distance between the large-diameter section located closest to the end face of the end portion and the fastener is within 4 mm.

Description

Tube Assembly

[0001] The technology of the present disclosure relates to tube assemblies.

[0002] US Pat. No. 5,250,041 and WO 2017 / 042899 describe a tube assembly including a tube for delivering a liquid and a connector connected to an end of the tube.

[0003] In such tube assemblies, leakage, where liquid leaks from the connection between the tube and the connector, can be a problem. Depending on the application, liquid leakage can cause serious contamination or even lead to poor product quality. Therefore, suppressing leakage in tube assemblies is an important issue.

[0004] One well-known measure to prevent leaks is to use a fixture to secure the tube and connector, such as a sturdy clamp, which has high leak prevention performance if cost is not a consideration.

[0005] However, in bioprocesses such as cell culture and medical applications, many tubing assemblies are single-use. Single-use assemblies often have cost-saving constraints, and there is a strong demand for low-cost leak suppression.

[0006] The technology disclosed herein provides a tube assembly that can effectively suppress leaks while keeping costs down.

[0007] The tube assembly according to the disclosed technology includes at least one set of three components: a flexible tube for carrying a fluid; an insertion section to be inserted into the end of the tube; a connector having at least one large diameter section provided on a part of the insertion section and protruding radially; and a fastener that is provided at a single location on the end of the tube when the insertion section is inserted, between the end face of the end and the large diameter section located closest to the end face, and that fastens the end from the outside to secure the connector to the tube; and the axial distance between the large diameter section located closest to the end face of the end and the fastener is within 4 mm.

[0008] The inner diameter of the tube may range from 6 mm to 26 mm.

[0009] The radial protrusion height of the large diameter portion of the connector may be in the range of 0.5 mm to 2 mm.

[0010] The large diameter portion of the connector may be a maximum diameter portion where the outer diameter of the insertion portion is greatest.

[0011] The connector may have a flange portion on the proximal end side of the insertion portion against which the end face of the end of the tube can abut.

[0012] The large diameter portion of the connector may have a tapered shape in which the diameter increases from the tip end side toward the base end side in the insertion direction.

[0013] The fastening device may be a fastening band having a strip-shaped band portion that can be wrapped around the outer peripheral surface of the end of the tube, a head portion provided at one end of the band portion with an insertion hole through which the other end side of the band portion is inserted, and the insertion hole has a claw formed on the head portion to prevent the inserted portion on the other end side from falling off.

[0014] The head portion may be provided in such a position that, when the tube is fastened, the insertion direction of the insertion hole is along a tangent direction to the outer periphery of the tube.

[0015] When there are multiple sets, the types of fasteners may be the same.

[0016] The connector may include at least one of a connector used to connect a tube to a container that contains a fluid, and a connector used to connect a plurality of tubes.

[0017] The container may be a single-use bag.

[0018] The connector may constitute a branching portion that branches the fluid flow path into a plurality of flow paths.

[0019] The material of the tube may be selected from at least one of silicone, polyvinyl chloride, thermoplastic elastomers, and ethylene vinyl acetate.

[0020] The tubing assembly may be used in bioprocessing.

[0021] The tubing assembly may be used in combination with a tubing pump.

[0022] According to the technology of the present disclosure, it is possible to effectively suppress leaks while suppressing costs.

[0023] 1 is a diagram showing an example of a tube assembly; FIG. 2 is a diagram showing a connector for connecting a plurality of tubes; FIG. 3 is an exploded perspective view showing an example of a tube assembly; FIG. 4 is a cross-sectional view of the fastener shown in FIG. 5; FIG. 6 is a cross-sectional view of the fastener shown in FIG. 6; FIG. 7 is a diagram showing the procedure for assembling a tube assembly; FIG. 8 is a diagram showing dimensions of each part of a tube assembly; FIG. 9 is a diagram showing dimensions of each part of a tube assembly of a comparative example; FIG. 10 is a diagram showing an example of a T-shaped connector; FIG. 11 is a diagram showing an example of a Y-shaped connector; FIG. 12 is a diagram showing experimental results of a water leakage pressure resistance test; FIG. 13 is a diagram showing an experimental method; FIG. 14 is a diagram showing experimental results of a water leakage pressure resistance test for the technology of the present disclosure; FIG. 15 is a diagram showing experimental results of a water leakage pressure resistance test for a comparative example.

[0024] As shown in FIG. 1 , a tube assembly 11 according to the technology of the present disclosure is used, for example, in bioprocessing applications such as the production of biopharmaceuticals and vaccines. In a bioprocess, for example, the tube assembly 11 is used together with a plastic bag 10. The plastic bag 10 contains process solutions used in each step of the bioprocess. The process solutions include, for example, cell suspensions used in cell culture, culture media, culture media additives, buffers, and the like. The plastic bag 10 is an example of a "container" according to the technology of the present disclosure.

[0025] The tube assembly 11 is connected to the plastic bag 10 via a port 12 provided in the plastic bag 10. The tube assembly 11 has a flexible tube 16 through which a fluid including a process solution flows. The tube 16, for example, supplies and discharges the process solution to and from the plastic bag 10. Using this tube assembly 11, for example, perfusion culture, in which cells are cultured while circulating a cell suspension, is performed. A pump 13 is connected to the tube 16, and the process solution is delivered by the pressure applied by the pump 13.

[0026] In bioprocessing, it is important to prevent contamination to ensure the quality of the product, so the tube assembly 11 and plastic bag 10 are single-use.

[0027] A tube pump is used as the pump 13, for example. As is well known, a tube pump applies liquid transfer pressure to the liquid in the tube 16 by compressing the tube 16 from the outside, so the tube pump does not come into contact with the liquid in the tube 16. Therefore, the tube pump can be used repeatedly as long as the tube 16 is replaced. In bioprocess applications, such tube pumps are often used from the perspective of preventing contamination.

[0028] The capacity of the plastic bag 10 is, for example, approximately 500 L. Considering the need to process a relatively large volume of process solution, such as in a bioprocess involving perfusion culture of cells, the capacity is preferably 50 L or more. A capacity of approximately 100 L to 1000 L is more preferable.

[0029] As shown in FIGS. 2 and 3 , the tube assembly 11 is an assembly including a tube 16, a connector 17, and a fastener 18. The material of the tube 16 is a flexible resin, for example, selected from at least one of silicone, polyvinyl chloride (PVC), thermoplastic elastomers (TPE), and ethylene-vinyl acetate (EVA). The inner diameter of the tube 16 is, for example, in the range of 6 mm to 26 mm. This is the typical size for tubes 16 used in bioprocessing. The connector 17 is, for example, a connector for connecting multiple tubes 16 together.

[0030] As shown in FIG. 3 , the connector 17 is attached to the end 16A of the tube 16. A flow path communicating with the conduit of the tube 16 is formed inside the connector 17. The connector 17 has an insertion portion 17A that is inserted into the end 16A of the tube 16. The insertion portion 17A has a shaft portion 17B having an outer diameter that serves as a reference for the insertion portion 17A. The connector 17 is available in a variety of sizes corresponding to the inner diameter of the tube 16, and the size of the connector 17 is selected based on the inner diameter of the tube 16 to be attached. The shaft portion 17B has an outer diameter that corresponds to the inner diameter of the tube 16 and serves as a reference for determining the size of the connector 17. Because the connector 17 is attached to the elastic tube 16, the outer diameter of the shaft portion 17B of a connector 17 sized to correspond to the inner diameter of the tube 16 is approximately the same as or slightly larger than the inner diameter of the tube 16. This allows the elastic force of the tube 16 to generate a clamping force that clamps the shaft portion 17B.

[0031] The insertion portion 17A has a large diameter portion 17C that is larger in diameter than the shaft portion 17B in a portion thereof. As an example, the large diameter portion 17C is provided on the tip side that first enters the tube 16, and protrudes radially from the outer circumferential surface of the shaft portion 17B. As an example, the large diameter portion 17C has a tapered shape in which the diameter increases from the tip side toward the base end in the insertion direction. In the large diameter portion 17C, the base end side is the maximum diameter portion 17C1. The large diameter portion 17C is an example of a "large diameter portion" in the technology of the present disclosure. The maximum diameter portion 17C1 is an example of a "maximum diameter portion" in the insertion portion 17A where the outer diameter is the largest.

[0032] Large diameter portion 17C functions as a catch portion that prevents tube 16 from coming off when insertion portion 17A of connector 17 is inserted into tube 16. In addition, large diameter portion 17C is tapered and narrowed toward the tip, making it easier to insert connector 17 into tube 16.

[0033] It should be noted that the tapered large diameter portion 17C does not necessarily have to have a larger diameter than the shank 17B throughout the entire axial direction. That is, the large diameter portion 17C only needs to have a larger diameter than the shank 17B at least on the base end side, and the diameter on the tip end side where the diameter becomes smaller may be smaller than the shank 17B. Also, instead of making the large diameter portion 17C tapered, it may be tapered in stages.

[0034] A flange 17D protruding in the radial direction is provided on the proximal end of the insertion section 17A. The flange 17D functions as an abutment section against which the open end surface 16B of the end 16A of the tube 16 can abut.

[0035] 2 , two tubes 16 are connected by a connector 17. As an example, the connector 17 is attached to each end 16A of the two tubes 16 to be connected. The two tubes 16 are then connected by fitting the flange portions 17D of the two connectors 17 together. In this way, as an example, the connector 17 functions as a joint that connects multiple tubes 16.

[0036] In this example, the base ends (i.e., flange portions 17D) of the connectors 17 attached to the two tubes 16 are connected together by fitting, thereby linking the two tubes 16. In other words, two separate and independent connectors 17 are combined to function as a single joint that links the two tubes 16. However, it is also possible to provide insertion portions 17A at both ends of a single connector, and to have the single connector function as a joint that links the two tubes 16.

[0037] As will be described later, the "connector" according to the technology of the present disclosure can take various forms, and in addition to the form shown in FIG. 2, connector 17 also includes connector 170 (see FIG. 11) and connector 171 (see FIG. 12) that can connect three tubes 16. Furthermore, connectors also include port 12 provided in plastic bag 10 shown in FIG. 1. That is, the connector may be a connector used to connect tube 16 and plastic bag 10. In this case, port 12 is provided with insertion portion 17A, shaft portion 17B, and large diameter portion 17C.

[0038] 4 and 5, fastener 18 fastens end 16A of tube 16 from the outside when insertion portion 17A is inserted, thereby fixing connector 17 to tube 16. Fastener 18 is provided at one location between end surface 16B of end 16A and large diameter portion 17C.

[0039] In this example, only one large diameter portion 17C is provided in the insertion portion 17A, but multiple large diameter portions 17C may be provided in the insertion portion 17A. In this case, the location where the fastener 18 is provided is between the end face 16B of the end portion 16A and the large diameter portion 17C that is closest to the end face 16B of the end portion 16A in the axial direction of the end portion 16A.

[0040] As an example, the fastener 18 is a fastening band having a strip-shaped band portion 18A that can be wrapped around the outer peripheral surface of the end portion 16A of the tube 16, a head portion 18B provided at one end of the band portion 18A, an insertion hole 18C through which the other end of the band portion 18A is inserted, and a claw formed on the head portion 18B to prevent the inserted portion of the other end from falling out of the insertion hole 18C. The band portion 18A is wrapped around the end portion 16A following the shape of the end portion 16A and fastens the end portion 16A from all directions around the outer peripheral surface of the end portion 16A. Such fasteners 18 are generally used to bundle multiple cables together, and are therefore also called binding bands, cable ties, etc.

[0041] In fastener 18, head portion 18B has insertion hole 18C formed along the extension direction of band portion 18A. In other words, head portion 18B is oriented such that, when tube 16 is fastened, the insertion direction of insertion hole 18C is along the tangent direction TL of the outer periphery of tube 16. By using such fastener 18, it is less likely that a gap will form between fastener 18 and the outer periphery of end portion 16A of tube 16.

[0042] 6 and 7 may be used as the fastener 18. In the fastener 180, the head portion 180B has an insertion hole 180C formed in a direction intersecting the extension direction of the band portion 180A. In other words, when the head portion 180B fastens the tube 16, the insertion direction of the insertion hole 180C is inclined in a direction away from the outer periphery of the tube 16 with respect to the tangent direction TL of the outer periphery of the tube 16. Therefore, compared to the fastener 18 shown in FIG. 5, a gap is more likely to occur between the fastener 180 and the outer periphery of the end portion 16A of the tube 16.

[0043] 8A and 8B illustrate a method for assembling the tube assembly 11. First, as shown in FIG. 8A, the tube 16 and the connector 17 are aligned along their imaginary axes AX, and the end face 16B of the end 16A of the tube 16 and the insertion portion 17A of the connector 17 are positioned facing each other. In this state, the insertion portion 17A is inserted into the end 16A so that the end 16A covers the insertion portion 17A. Because the tube 16 is flexible, the insertion portion 17A is inserted while pushing the opening of the end 16A outward in the radial direction. As shown in FIG. 8B, the end 16A passes over the large diameter portion 17C and is inserted until the end face 16B abuts against the flange portion 17D.

[0044] As shown in FIG. 8C , when the insertion portion 17A is inserted into the end portion 16A, the fastener 18 is attached to the end portion 16A at a single location between the end surface 16B of the end portion 16A and the large-diameter portion 17C closest to the end surface 16B. The fastener 18 is attached as follows: First, the band portion 18A is wrapped around the end portion 16A. Then, the band portion 18A is inserted into the insertion hole 18C of the head portion 18B from the other end side (i.e., the side opposite the head portion 18B). The inserted end portion of the other end is then pulled, causing the band portion 18A to fasten the end portion 16A from the outside. The portion of the band portion 18A inserted into the insertion hole 18C of the head portion 18B engages with the claws of the head portion 18B, preventing it from being returned in the opposite direction to the insertion direction. This prevents the band portion 18A from falling off and maintains the fastening force. After the fastening is completed, the excess length of the band portion 18A that has passed through the insertion hole 18C of the head portion 18B is cut off.

[0045] The position where fastener 18 is attached corresponds to a position on shaft portion 17B that is closer to the base end than large diameter portion 17C in connector 17. Fastener 18 secures connector 17 to tube 16 by tightening end portion 16A from the outside.

[0046] As shown in Figure 8(B), when the insertion portion 17A of the connector 17 is inserted into the tube 16, the elasticity of the tube 16 causes the tube 16 to generate a clamping force that clamps the insertion portion 17A. This causes the inner periphery of the tube 16 to tightly contact the outer periphery of the insertion portion 17A. Then, as shown in Figure 8(C), by further attaching a clamping device 18, it is possible to generate a clamping force greater than the elasticity of the tube 16. This increases the tight contact between the inner periphery of the tube 16 and the outer periphery of the insertion portion 17A, thereby suppressing leakage of liquid from the connection portion with the connector 17.

[0047] 9, when the axial distance between the large diameter portion 17C and the fastener 18 is S, the fastener 18 is attached within a range that satisfies the condition S≦4 mm. Specifically, the distance S is the axial distance between the end face on the base end side of the large diameter portion 17C and the end face on the tip end side of the fastener 18. In this example, the end face on the base end side of the large diameter portion 17C coincides with the end face on the base end side of the maximum diameter portion 17C1 because the base end side of the large diameter portion 17C is the maximum diameter portion 17C1.

[0048] The components of the tube assembly 11, namely, the connector 17, the tube 16, and the fastener 18, are, for example, commercially available products. The approximate relationship between the sizes of the components of the commercially available connector 17 and the tube 16 is as follows, for example. In the connector 17, the diameter D0 of the shank 17B (see FIG. 9A) is slightly larger than the inner diameter TDI of the corresponding tube 16 (see FIG. 9B), as described above. For example, if the inner diameter TDI of the tube 16 is 1 / 2 inch (12.70 mm) in inches, the diameter D0 of the shank 17B of the connector 17 that is compatible with the 1 / 2-inch tube 16 is approximately 14 mm.

[0049] In addition, in the ½-inch connector 17, the diameter D1 (see FIG. 9A) of the maximum diameter portion 17C1 is, for example, approximately 16 mm. The radial protrusion height H (see FIG. 9A) of the maximum diameter portion 17C1 relative to the shaft portion 17B is half the difference in outer diameter between the shaft portion 17B and the maximum diameter portion 17C1, and is therefore approximately 1 mm in this example.

[0050] While there are various sizes of tubing 16, those used in bioprocessing applications are often in the range of ¼ inch to 1 inch, i.e., 6 mm to 26 mm. The diameter D0 of the shaft portion 17B of various connectors 17 corresponding to this size range is approximately 6 mm to approximately 26 mm. Furthermore, in various connectors 17 corresponding to this size range, the protruding height H of the maximum diameter portion 17C1 is in the range of 0.5 mm to 2 mm.

[0051] The outer diameter TDE (see FIG. 9B) of the tube 16 with an inner diameter of 1 / 2 inch (12.70 mm) is approximately 19.05 mm, and in this case, the wall thickness of the tube 16 is approximately 3.5 mm, which is half the difference between the outer diameter TDE and the inner diameter TDI (approximately 7 mm). The wall thickness of commercially available tubes 16 in the range of 1 / 4 inch to 1 inch (range of 6 mm to 26 mm) is approximately 3 mm to 5 mm.

[0052] In commercially available connectors 17 in the ¼ inch to 1 inch range, the axial length AD (see FIG. 9A) of the shaft portion 17B is in the range of about 10 mm to about 25 mm, with many in the range of about 11 mm to about 16 mm. Furthermore, the width W (see FIG. 9B) of the band portion 18A of commercially available fasteners 18 is in the range of about 4 mm to 6 mm, with the fastener 18 in this example being about 5 mm.

[0053] In a tube assembly 11 composed of components of this size, setting the spacing S to 4 mm or less has the following advantages. Specifically, as described above, when the connector 17 is inserted into the tube 16, the elasticity of the tube 16 generates a clamping force that clamps the insertion portion 17A of the connector 17. In the insertion portion 17A, the clamping force due to the elasticity of the tube 16 is greater at the large-diameter portion 17C, which has a larger diameter, than at the shank 17B. In addition to this elasticity, the presence of the clamping tool 18 can generate a clamping force greater than the elasticity of the tube. It is believed that this force is greater the closer the clamping position is to the large-diameter portion 17C.

[0054] 10 of a comparative example in which the distance S is greater than 4 mm, if the fastening position is far from the large diameter portion 17C, even if the end portion 16A is fastened with the fastener 18, the fastening force of the fastener 18 is unlikely to be transmitted to the position of the large diameter portion 17C. The farther the position of the fastener 18 is from the large diameter portion 17C, that is, the larger the distance S, the less the fastening force of the fastener 18 acts on the large diameter portion 17C.

[0055] As shown in Figure 9, if the gap S is within 4 mm, a clamping force equal to or greater than the elastic force of the tube 16 can be effectively applied to the large diameter portion 17C. This effectively prevents liquid leakage. As described above, cost reduction is highly desirable for single-use tube assemblies 11. Therefore, according to the technology disclosed herein, by devising the mounting position of one clamping tool 18, it is possible to achieve both cost reduction and leakage prevention.

[0056] Furthermore, although the connector constituting the tube assembly 11 has been described as an example of a connector that connects two tubes 16 in series, the connector 17 may take other forms, such as the connector 170 shown in Fig. 11 and the connector 171 shown in Fig. 12. The connector 170 shown in Fig. 11 is a connector that can connect three tubes 16 and is a so-called T-connector in which connectors 17 having insertion portions 17A are provided on three sides. As an example, the connector 170 has each connector 17 formed integrally, forming an overall T-shape.

[0057] Similarly to the connector 170 shown in FIG. 11, the connector 171 shown in FIG. 12 is capable of connecting three tubes 16, but the connectors 17 provided on the three sides have different angles, making it a Y-shaped connector with an overall Y-shape.

[0058] Even when the tube assembly 11 is constructed using the connector 170 shown in FIG. 11 and the connector 171 shown in FIG. 12, the attachment position of the fastener 18 is set so as to satisfy the condition of the spacing S (S≦4 mm) shown in FIG. 9.

[0059] Such connectors 170 and 171 constitute branching sections in the tube assembly 11 that branch the flow paths of fluids flowing in from the multiple tubes 16 into multiple flow paths.

[0060] As described above, there are various types of connectors that make up the tube assembly 11. In addition, there may be multiple connectors 17. That is, the tube assembly 11 according to the technology of the present disclosure may include at least one set of three components: the tube 16, the connector 17 (connectors 170, 171, etc. in addition to the connector 17), and the fastener 18.

[0061] Furthermore, even when the tube assembly 11 includes multiple sets of three components and various connectors 17, it is preferable that the fasteners 18 be of the same type. Using the same type of fasteners 18 is expected to improve the assembly process. Improvements to the assembly process include, for example, reducing work errors such as mixing up the type of fastener 18, and improving workability by allowing the use of the same tools. Of course, using the same type of fasteners 18 is also expected to reduce costs by reducing component costs.

[0062] 13 to 17 illustrate experimental results of a water leakage pressure test demonstrating the leak suppression effect at the connection between the tube 16 and the connector 17 of the tube assembly 11 according to the technology disclosed herein. FIG. 13 is a graph showing the change in water leakage pressure when the distance S is changed, with the horizontal axis representing the distance S (unit: mm) and the vertical axis representing the water leakage pressure (unit: MPa). The water leakage pressure is the limit pressure at which water leakage occurs. For example, a water leakage pressure of 0.12 MPa means that water leakage does not occur up to 0.12 MPa, but occurs above 0.12 MPa. As shown in FIG. 13 , when the distance S is 4 mm or less, the water leakage pressure is higher than when the distance S exceeds 4 mm. PUmax indicates the specified limit value for the operating pressure when the tube assembly 11 is actually used. PUmax is, for example, 0.11 MPa. It can be seen that when the distance S is 4 mm or less, the water leakage pressure exceeds PUmax.

[0063] The experimental method for the water leakage pressure resistance test shown in FIG. 13 will be described using FIG. 14 . As shown in FIG. 14 , first, the tube assembly 11 is assembled using three components: the tube 16, the connector 17, and the fastener 18. Then, all necessary locations in the tube assembly 11 are blocked except for the locations where water and air are injected. In this state, water is injected into the flow paths of the tube 16 and the connector 17. The water-injected flow paths are then further pressurized by injecting air. While pressurized by air, the free end of the tube 16 is bent from the connector 17 side as a base point, and water leakage is confirmed. The bending angle is 45° in both the positive and negative directions relative to the axial direction of the tube 16 when no external force is applied. The tube 16 is repeatedly bent while increasing the air pressure, and the water leakage pressure resistance is confirmed. The air pressure just before water leakage occurs is the water leakage pressure resistance.

[0064] The tube 16 used in the water leak pressure test of FIG. 13 is manufactured by Saint-Gobain and has the model number "374-500-4." The inner diameter of the tube 16 (see symbol TDI in FIG. 9B) is 1 / 2 inch (12.70 mm), the outer diameter (see symbol TDE in FIG. 9B) is 3 / 4 inch (19.05 mm), and the material is thermoplastic elastomer (TPE). The upper limit of the operating pressure specified for the tube 16 is 0.11 MPa. The connector 17 is manufactured by Eldon James and has the model number "Y0-8PP-QC." This connector 17 is a Y-shaped connector like the connector 170 shown in FIG. 12. The fastener 18 is manufactured by Panduit and has the model number "CBR2S-MO." The material is nylon, and the width (see symbol W in FIG. 9B) is 4.8 mm.

[0065] Under these conditions, a water leakage pressure resistance test was carried out while changing the position of the fastener 18 (the distance S in FIG. 9B), and the experimental results shown in FIG. 13 were obtained.

[0066] 15 and 16 show the experimental results of a similar water leakage pressure resistance test using test samples of tube assemblies 11 with different configurations. The test samples were three types, samples A to C. FIG. 15 shows the experimental results of the tube assemblies 11 according to the technology of the present disclosure, in which the spacing S was set to 4 mm or less for each of test samples A to C. FIG. 16 shows the experimental results of a comparative example in which the spacing S was set to greater than 4 mm for similar test samples A to C.

[0067] Test sample A is a tube assembly 11 that combines a tube 16 with an inner diameter of ¾ inch (19.05 mm) and three types of connectors 17 corresponding to the ¾ inch diameter. The fasteners 18 are manufactured by the aforementioned "Panduit" company. In other words, test sample A uses three types of connectors 17, and if one of each type of connector 17 is provided, it includes at least three combinations of tube 16, connector 17, and fastener 18. The first type of connector 17 is manufactured by "CPC" and is called "AseptiQuik (registered trademark) G" with the model number "AQG17012." The protrusion height H of this connector 17 is 1.78 mm. The second type is manufactured by "Cytiva" and is called "ReadyMate (registered trademark)" with the model number "28-9366-89." The protruding height H of this connector 17 is 1.20 mm. The third connector is manufactured by Eldon James, has the product name "Tee Fitting," and the model number is "T0-12PP-QC." The third connector 17 is a T-shaped connector as shown in FIG. 11, and has an insertion portion 17A consisting of a horizontal portion extending laterally and a vertical portion extending vertically. The protruding height H of both the vertical and horizontal portions of this connector 17 is 0.87 mm.

[0068] Test sample A also uses three types of tubing 16. All three types of tubing 16 have an inner diameter of 3 / 4 inch (19.05 mm), but their outer diameters vary slightly. The first type is manufactured by DuPont, has a trade name of Liveo™ Pharma TPE Tubing, has a model number of 12089901, and has an outer diameter of 9 / 8 inch (28.58 mm). The second type is manufactured by Saint-Gobain, has a trade name of C-Flex™ 374, has a model number of 374-750-6, and has an outer diameter of 9 / 8 inch (28.58 mm). The third one is manufactured by DuPont, has the trade name Liveo (trademark) Pharma-65 Reinforced Tubing, has the model number 4036490, and has an outer diameter of 1.1 inches (27.94 mm).

[0069] Test sample B uses one type of tubing 16 and two types of connectors 17. Test sample B has a configuration in which multiple tubings 16 are connected in series, as shown in FIG. 2. The inner diameter of the tubing 16 is 1 / 2 inch (12.70 mm), and connectors 17 corresponding to the size of the tubing 16 are used. In test sample B, the tubing 16 is manufactured by DuPont, has the trade name "Liveo™ Pharma TPE Tubing," has the model number "12078432," and has an outer diameter of 3 / 4 inch (19.05 mm). The first connector 17 is manufactured by CPC, has the trade name "AseptiQuik™ G," and has the model number "AQG17008." The protrusion height H of this connector 17 is 0.64 mm. The second one is manufactured by Cytiva, has the product name ReadyMate (registered trademark), and has the model number 28-9366-88. The protruding height H of this connector 17 is 0.55 mm.

[0070] Like test sample B, test sample C uses one type of tube 16 and two types of connectors 17. Like test sample B, test sample C also has a configuration in which multiple tubes 16 are connected in series. Like test sample B, the inner diameter of the tube 16 is 1 / 2 inch (12.70 mm), and connectors 17 corresponding to the size of the tube 16 are used. In test sample C, the manufacturer of the tube 16 is "Saint-Gobain", the product name is "C-Flex (registered trademark) 374", the model number is "374-500-4", and the outer diameter is 3 / 4 inch (19.05 mm). The connectors 17 of test sample C are the same as those of test sample B.

[0071] A water leakage pressure resistance test was conducted on these test samples A to C using the method shown in Figure 14. The air pressurization pressure value was set to the upper limit of the operating pressure of each tube 16. When the upper limit of the operating pressure was 0.11 MPa, the air pressurization pressure value was also 0.11 MPa. Furthermore, when the upper limit of the operating pressure exceeded 0.2 MPa, the upper limit was set to 0.2 MPa. Figures 15 and 16 show the occurrence of water leakage in this case.

[0072] In FIGS. 15 and 16 , the numerical value listed for each combination of connector 17 and tube 16 is the value of the spacing S that defines the position of fastener 18. In FIG. 15 , for example, in test sample A, the spacing S is 1.8 mm for the combination of DuPont tube 16 with model number "12089901" and CPC connector 17 with model number "AQG17012." The spacing S is 0.7 mm for the combination of the same tube 16 and Cytiva connector 17 with model number "28-9366-89." In FIG. 15 , the spacing S values ​​for all combinations n are within 4 mm. In contrast, in FIG. 16 , which shows the comparative example, the spacing S is 11.8 mm, 8.7 mm, 6.4 mm, and 4.9 mm, all of which are greater than 4 mm.

[0073] The hatched areas in Fig. 16 indicate where water leakage occurred, and it can be seen that water leakage occurred in some, but not all, combinations in Fig. 16. In contrast, there are no hatched areas in Fig. 15, and no water leakage occurred in any of the combinations. The experimental results of the water leakage test shown in Figs. 15 and 16 also show that it is effective to set the interval S that defines the position of the fastener 18 to 4 mm or less.

[0074] As described above, the tube assembly 11 according to the technology of the present disclosure includes at least one set of three components: a flexible tube 16 through which a fluid flows; a connector 17 having an insertion portion 17A inserted into an end portion 16A of the tube 16, and at least one large-diameter portion 17C provided on a portion of the insertion portion 17A and protruding radially; and a fastener 18 provided at a single location on the end portion 16A between an end face 16B of the end portion 16A and the large-diameter portion 17C located closest to the end face 16B when the insertion portion 17A is inserted, and fastening the end portion 16A from the outside to fix the connector 17 to the tube 16. The axial distance S between the large-diameter portion 17C located closest to the end portion 16A of the tube 16 and the fastener 18 is within 4 mm.

[0075] This makes it possible to effectively suppress leaks while keeping costs down. That is, by using only one fastener 18, component costs are reduced compared to using multiple fasteners 18, such as duplicated fasteners. Furthermore, by providing the fasteners 18 at positions where the spacing S is within 4 mm, leaks can be effectively suppressed even with a single fastener 18.

[0076] In the above embodiment, the inner diameter of the tube 16 is preferably in the range of 6 mm to 26 mm. The effect of setting the interval S that defines the position of the fastener 18 to 4 mm or less is considered to be particularly effective when the inner diameter of the tube 16 is in this range. Furthermore, since tubes 16 with inner diameters in the range of 6 mm to 26 mm are often used in bioprocess applications, the technology of the present disclosure is particularly effective in bioprocess applications.

[0077] In the above embodiment, the radial protrusion height H of the large diameter portion 17C of the connector 17 is in the range of 0.5 mm to 2 mm. Positioning the fastener 18 with a spacing S of 4 mm or less is particularly effective for connectors 17 having a maximum diameter portion 17C1 with a protrusion height H in the range of 0.5 mm to 2 mm. Insertion portions 17A having a maximum diameter portion 17C1 of this size are commercially available and therefore easy to obtain. This reduces costs compared to custom manufacturing.

[0078] Furthermore, in the above embodiment, in connector 17, large diameter portion 17C that defines spacing S with fastener 18 is maximum diameter portion 17C1, which is the largest outer diameter portion in insertion portion 17A. If spacing S between fastener 18 and maximum diameter portion 17C1 is 4 mm or less, it is considered that the fastening force from fastener 18 is most easily transmitted compared to a case in which large diameter portion 17C that defines spacing S is present separately from maximum diameter portion 17C1. For this reason, it is preferable that large diameter portion 17C that defines spacing S is maximum diameter portion 17C1.

[0079] In this example, the large diameter portion 17C that defines the spacing S is the maximum diameter portion 17C1, but it does not have to be the maximum diameter portion 17C1. This is because, as long as the large diameter portion 17C that defines the spacing S is the large diameter portion 17C that is located closest to the end face 16B of the end 16A of the tube 16, the effect of increasing the fastening force of the fastener 18 can be expected.

[0080] In the above embodiment, the connector 17 has a flange 17D on the proximal end side of the insertion section 17A, against which the end face 16B of the end section 16A of the tube 16 can abut. The presence of the flange 17D makes it easy to properly control the insertion amount of the tube 16 into the insertion section 17A of the connector 17, for example, by indicating an operation procedure such as inserting the tube 16 until it abuts against the flange 17D. This makes it possible to prevent leaks caused by insufficient insertion of the tube 16.

[0081] In the above embodiment, the large diameter portion 17C of the connector 17 has a tapered shape in which the diameter increases from the distal end toward the proximal end in the insertion direction. The tapered shape of the large diameter portion 17C makes it easy to insert the connector 17 into the tube 16, and the relatively larger diameter of the proximal end side catches on the inner diameter of the tube 16, making it difficult for the tube 16 to come off.

[0082] Furthermore, the large diameter portion 17C does not have to be tapered, and may have a constant diameter in the axial direction. Furthermore, the large diameter portion 17C does not have to be formed all the way to the tip, and may be provided in, for example, a central portion of the axial direction of the shank 17B. As described above, the large diameter portion 17C may be provided in two or more locations on the shank 17B. In this case, the distance S is the distance between the fastener 18 and the large diameter portion 17C closest to the end face 16B of the end portion 16A, as shown in FIG. 9 .

[0083] 4 and 5, the fastener 18 is a fastening band having a band-like band portion 18A that can be wrapped around the outer peripheral surface of the end portion 16A of the tube 16, a head portion 18B provided at one end of the band portion 18A, an insertion hole 18C through which the other end of the band portion 18A is inserted, and a claw formed on the head portion 18B to prevent the inserted portion of the other end from falling off the insertion hole 18C. The fastener 18 may also be a fastening band shown as fastener 180 in FIGS. 6 and 7. Since the fastener 18 is in the form of a commonly available cable tie, it is easy to use a commercially available product, and costs can be reduced.

[0084] The fastener 18 may be a type other than a clamping band such as the so-called cable tie shown in FIGS. 4 to 7 . Examples of such fasteners include hose bands and hose clips. Such hose bands and hose clips are composed of an annular portion that fastens the outer circumference of the tube 16 and an engaging portion that tightens the annular portion. The annular portions of hose bands and hose clips are often made of metal such as stainless steel, but due to concerns about corrosion of metal, plastic is preferred for use in bioprocessing. The engaging portion may be a screw type, clip type, gear type, or wire type, but all of these have a more complex structure than the head portion 18B of a clamping band such as a cable tie.

[0085] Although these hose bands and hose clips are more robust than tightening bands such as cable ties, they have the disadvantage of being expensive. In addition, the rigidity of the annular portion results in the following disadvantage in terms of workability: Because the annular portion is inflexible, the hose band or hose clip must be attached to the tube 16 before inserting the connector 17 into the tube 16. This makes it impossible to assemble the tube 16 according to the procedure shown in Figure 8, in which the connector 17 is inserted into the tube 16 and then the tightening device 18 is attached. This can increase the number of assembly steps, making the workability worse than when tightening bands are used.

[0086] Furthermore, because the annular portions of hose bands and hose clips are hard, it is necessary to select an appropriate size depending on the size of the tube 16. Tightening bands such as cable ties also come in multiple sizes depending on the length of the band portion 18A, but since the excess portion of the band portion 18A can be simply cut off, there is a greater degree of freedom in size selection compared to hose bands and hose clips. The degree of freedom in size selection not only affects costs, but also affects workability, such as preventing the wrong size from being selected.

[0087] In this way, using a fastening band as the fastener 18 is advantageous in terms of cost and workability compared to using a hose band and a hose clip.

[0088] 4 and 5, the head portion 18B is preferably positioned such that, when the tube 16 is tightened, the insertion direction of the insertion hole 18C is aligned with the tangent direction TL of the outer circumference of the tube 16. This makes it less likely that a gap will form between the tightening band and the outer circumference of the tube 16, making it easier to apply a tightening force evenly around the entire circumference of the tube 16. Therefore, a tightening device 18 of this type is effective in suppressing leaks.

[0089] Furthermore, in the above embodiment, when there are multiple sets of tubes 16, connectors 17, and fasteners 18, it is preferable that the fasteners 18 are the same type. This is expected to prevent work errors such as mix-ups by using the same type of fasteners 18, and to improve workability by allowing the use of the same tools. Of course, using the same type of parts also has the effect of reducing costs.

[0090] In the above embodiment, the connector 17 is used to connect multiple tubes 16. As described above, the connector 17 may also be used to connect the tubes 16 to a plastic bag 10, which is an example of a container for storing a fluid, like the port 12 shown in Fig. 1. As such, the connector 17 can be used for various purposes, and therefore the tube assembly 11 according to the technology of the present disclosure can be applied to various forms.

[0091] Furthermore, in the above embodiment, a container that uses a connector 17 as the port 12, such as the plastic bag 10, is single-use. When the tube assembly 11 is used in combination with such a single-use plastic bag 10, there is a strong demand for cost reduction. Therefore, in such cases, the technology of the present disclosure, which has the effect of reducing costs, is particularly effective.

[0092] In the above-described embodiment, the connector 17 may also constitute a branching portion that branches the fluid flow path into multiple flow paths, as shown by the connector 170 in Fig. 11 and the connector 171 in Fig. 12. This allows the technology of the present disclosure to be applied to a variety of tube assemblies 11.

[0093] In the above embodiment, the material of the tube 16 is selected from at least one of silicone, polyvinyl chloride, thermoplastic elastomer, and ethylene vinyl acetate. These materials are often used as materials for the tube 16. The technology of the present disclosure is highly versatile because it can be effectively used with a tube 16 made of such a material.

[0094] Furthermore, in the above embodiment, the tube assembly 11 is used in a bioprocess. In bioprocess applications, leaks often cause serious contamination and lead to a decrease in product quality, so there is a high need to prevent leaks. On the other hand, since the components used are often single-use, there is also a high need to reduce costs. For this reason, the technology disclosed herein is particularly effective in bioprocess applications.

[0095] In the above embodiment, the tube assembly 11 is used in combination with a tube pump as the pump 13 (see FIG. 1 ). As described above, tube pumps are often used in bioprocessing applications to prevent contamination. However, because a tube pump applies a liquid delivery pressure to the tube 16 while compressing it from the outside, the tube 16 is subjected to a load, such as periodic bending of the tube 16 due to vibration, in addition to the liquid delivery pressure. Naturally, the load due to vibration is also applied to the connection between the tube 16 and the connector 17. Therefore, when the tube assembly 11 is used in combination with a tube pump, it is more important to take measures to prevent liquid leakage at the connection than when the tube assembly 11 is used in combination with other pumps. In the experimental method shown in FIG. 14 , one of the reasons for repeatedly applying a bending load to the tube 16 is to simulate the load applied to the tube 16 due to the vibration of the tube pump. The technology disclosed herein has been proven effective in preventing leaks due to the vibration of such a tube pump, and is therefore particularly effective when used in combination with a tube pump.

[0096] In addition, the tube assembly 11 according to the technology disclosed herein can be used not only to connect to the plastic bag 10 in a bioprocess, but also to connect various devices used in the bioprocess other than the plastic bag 10.

[0097] Although the tube assembly 11 has been described as being used in a bioprocess, the tube assembly 11 may also be used in medical applications for transporting blood, etc. The tube assembly 11 may also be used in fields where it is necessary to effectively prevent leaks while keeping costs down.

[0098] Although the fluid flowing through the tube assembly 11 is a liquid, the fluid may be a gas.

[0099] The above embodiments further disclose the following. [Supplementary Item 1] A tube assembly including at least one set of three components: a flexible tube through which a fluid flows; a connector having an insertion section to be inserted into the end of the tube and at least one large-diameter section provided on a part of the insertion section and protruding radially; and a fastener provided at the end of the tube with the insertion section inserted, at a location between the end face of the end and the large-diameter section located closest to the end face, and fastening the end from the outside to secure the connector to the tube, wherein the axial distance between the large-diameter section located closest to the end face of the end and the fastener is 4 mm or less. [Supplementary Item 2] A tube assembly according to Supplementary Item 1, in which the inner diameter of the tube is in the range of 6 mm to 26 mm. [Supplementary Item 3] A tube assembly according to Supplementary Item 1 or Supplementary Item 2, in which the radial protrusion height of the large-diameter section of the connector is in the range of 0.5 mm to 2 mm. [Supplementary Item 4] The tube assembly according to any one of Supplementary Items 1 to 3, wherein the large-diameter portion of the connector is a maximum-diameter portion of the insertion portion where the outer diameter is greatest. [Supplementary Item 5] The tube assembly according to any one of Supplementary Items 1 to 4, wherein the connector has a flange portion at the proximal end of the insertion portion against which the end face of the end of the tube can abut. [Supplementary Item 6] The tube assembly according to any one of Supplementary Items 1 to 5, wherein the large-diameter portion of the connector has a tapered shape whose diameter increases from the distal end to the proximal end in the insertion direction. [Supplementary Item 7] The tube assembly according to any one of Supplementary Items 1 to 6, wherein the fastener is a fastening band having a strip-shaped band portion that can be wrapped around the outer peripheral surface of the end of the tube, and a head portion provided at one end of the band portion, the head portion having an insertion hole through which the other end of the band portion is inserted, and a pawl formed in the insertion hole to prevent the inserted portion of the other end from falling off. [Supplementary Item 8] The tube assembly according to Supplementary Item 7, wherein the head portion is provided in a position such that the insertion direction of the insertion hole is along the tangent direction of the outer periphery of the tube when the tube is fastened. [Supplementary Item 9] The tube assembly according to any one of Supplementary Items 1 to 8, wherein when there are multiple sets, the fasteners are of the same type.[Supplementary Item 10] The tube assembly according to any one of Supplementary Items 1 to 9, wherein the connector includes at least one of a connector used to connect a tube to a container containing a fluid and a connector used to connect multiple tubes. [Supplementary Item 11] The tube assembly according to any one of Supplementary Items 1 to 10, wherein the container is a single-use bag. [Supplementary Item 12] The tube assembly according to any one of Supplementary Items 1 to 11, wherein the connector forms a branching section that branches a fluid flow path into multiple flow paths. [Supplementary Item 13] The tube assembly according to any one of Supplementary Items 1 to 12, wherein the material of the tube is selected from at least one of silicone, polyvinyl chloride, thermoplastic elastomer, and ethylene vinyl acetate. [Supplementary Item 14] The tube assembly according to any one of Supplementary Items 1 to 13, wherein the tube is used in a bioprocess. [Supplementary Item 15] The tube assembly according to any one of Supplementary Items 1 to 14, wherein the tube is used in combination with a tube pump.

[0100] The above-described description and illustrations are a detailed explanation of the parts related to the technology of the present disclosure and are merely an example of the technology of the present disclosure. For example, the above description of the configuration, functions, actions, and effects is an explanation of an example of the configuration, functions, actions, and effects of the parts related to the technology of the present disclosure. Therefore, it goes without saying that unnecessary parts may be deleted, new elements may be added, or replacements may be made to the above-described description and illustrations within the scope of the gist of the technology of the present disclosure. Furthermore, to avoid confusion and facilitate understanding of the parts related to the technology of the present disclosure, the above-described description and illustrations omit explanations of common technical knowledge that do not require particular explanation to enable the implementation of the technology of the present disclosure.

[0101] In this specification, "A and / or B" is synonymous with "at least one of A and B." In other words, "A and / or B" means that it may be only A, only B, or a combination of A and B. Furthermore, in this specification, the same concept as "A and / or B" is also applied when three or more things are expressed by connecting them with "and / or."

[0102] The disclosure of Japanese Patent Application No. 2024-134661, filed on August 9, 2024, is incorporated herein by reference in its entirety. In addition, all documents, patent applications, and technical standards described herein are incorporated herein by reference to the same extent as if each individual document, patent application, and technical standard was specifically and individually indicated to be incorporated by reference.

Claims

1. A tube assembly comprising at least one set of three components: a flexible tube for allowing fluid to flow; a connector having an insertion section inserted into the end of the tube and at least one large diameter section provided on a part of the insertion section and protruding radially; and a fastener provided at a single location on the end between the end face of the end and the large diameter section located closest to the end face when the insertion section is inserted, for fastening the end from the outside to secure the connector to the tube; wherein the axial distance between the large diameter section located closest to the end face of the end and the fastener is within 4 mm.

2. The tube assembly of claim 1, wherein the inner diameter of the tube ranges from 6 mm to 26 mm.

3. A tube assembly according to claim 1, wherein the radial protrusion height of the large diameter portion of the connector is in the range of 0.5 mm to 2 mm.

4. The tube assembly according to claim 1, wherein the large diameter portion of the connector is a maximum diameter portion where the outer diameter of the insertion portion is greatest.

5. The tube assembly according to claim 1, wherein the connector has a flange portion on the proximal end side of the insertion portion against which the end face of the end of the tube can be abutted.

6. A tube assembly according to claim 1, wherein the large diameter portion of the connector has a tapered shape in which the diameter increases from the tip end toward the base end in the insertion direction.

7. The tube assembly according to claim 1, wherein the fastening device is a fastening band having a band-like portion that can be wrapped around the outer periphery of the end of the tube, a head portion provided at one end of the band portion, with an insertion hole through which the other end of the band portion is inserted, and a claw formed in the insertion hole to prevent the inserted portion of the other end from falling off.

8. A tube assembly according to claim 7, wherein said head portion is oriented such that, when said tube is fastened, the insertion direction of said insertion hole is along the tangent direction of the outer periphery of said tube.

9. The tube assembly according to claim 1, wherein when there are a plurality of sets, the types of fasteners are the same.

10. The tube assembly according to claim 1, wherein the connector includes at least one of a connector used to connect the tube to a container containing the fluid, and a connector used to connect a plurality of tubes.

11. The tube assembly of claim 10, wherein the container is a single-use bag.

12. The tube assembly according to claim 1, wherein the connector forms a branching portion that branches the fluid flow path into a plurality of flow paths.

13. The tube assembly of claim 1, wherein the tube material is selected from at least one of silicone, polyvinyl chloride, thermoplastic elastomers, and ethylene vinyl acetate.

14. The tube assembly according to claim 1, which is used in a bioprocess.

15. The tube assembly of claim 1 used in combination with a tube pump.

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