Valve assembly with directional flow path

Abstract

A valve assembly having a multidirectional flow path includes a valve body that includes respective hinged portions that define respective passages extending through the valve body when the valve body is in a closed state. A flexible conduit or tube having a loop portion and a plurality of branches extending from the loop portion is at least partially located within the valve body. Portions of the loop extending beyond the valve body are encapsulated by respective rigid sheaths. A plurality of valves are located on the valve body and are used to selectively clamp the loop portion in different clamped configurations to direct fluid to or from particular branches. The valve assembly can be integrated into a manufacturing process or other production process having optional additional sheaths that encapsulate the flexible conduit branches.

Description

[0001] This application is a divisional application. The original parent application has the application number 201680057308.7 (international application number PCT / US2016 / 055016), the application date is September 30, 2016, and the invention title is "Valve assembly with directional flow path". Technical Field

[0002] The field of this invention generally relates to valve systems for use in conjunction with pharmaceutical or bioprocess applications. More specifically, the field of this invention relates to valve systems comprising flexible, sterile catheters or tubing that can be used in pharmaceutical or bioprocess applications. The valve assemblies described herein are particularly suitable for use with reflux-based chromatography, filtration, or capture applications. Background Technology

[0003] Many commercial products are manufactured using chemical and biological processes. For example, scaled-up reactors and other equipment are used to manufacture commercial quantities of pharmaceuticals. So-called biologics are drugs or other compounds manufactured or isolated from living organisms such as cells or tissues. Biologics can consist of proteins, nucleic acids, or complex combinations of these substances. They can even include living organisms such as cells. Manufacturing commercial-grade biologics requires complex and expensive equipment. In pharmaceuticals and biologics, various processing steps are required, for example, before obtaining the final product. For example, in the case of biologics, cells may be grown in growth chambers, and the nutrients in the growth chamber may need to be carefully regulated. Waste products from the cells may also need to be removed from the fermentation chamber on a controlled basis. As another example, it may be necessary to extract and concentrate biological products produced by living cells or other organisms. This process may include various filtration and separation techniques.

[0004] Because there are many separate methods required to manufacture the final product, various reagents, solutions, and rinsing agents are typically pumped or otherwise delivered to various subsystems using tubing and associated valves. These systems can be very bulky and structurally complex due to the large number of tubing, valves, sensors, etc., that may be required within them. These systems not only appear complex (e.g., like spaghetti), but they also include many components that need to be sterilized between uses to avoid cross-contamination. In fact, in the case of pharmaceutical and biologics manufacturing, the Food and Drug Administration (FDA) has become increasingly stringent regarding the cleaning, sterilization, or biocontamination reduction processes required for drug and biologic manufacturing. This is a particularly concerning issue because many of these products are manufactured in batches, requiring repeated cleaning, sterilization, or biocontamination reduction activities on multiple components.

[0005] Recently, disposable solutions using flexible (e.g., silicone) tubing have been proposed for use in manufacturing processes. Flexible tubing can be discarded after use and replaced with new tubing, thus avoiding the need for sterilization of part or all of the equipment. For valve operation, the flexible tubing is placed within a two-piece valve, and an actuator is used to selectively clamp the flexible tubing. When the actuator clamps the flexible tubing, the valve is closed, and when the actuator leaves the flexible tubing in a stationary open state, the valve is open. These valves typically need to be engaged or connected to other processing operations. In many pharmaceutical or bioprocess applications, specific processing operations may require reversed fluid flow. In such cases, as with chromatography columns, this could require numerous individual valves and tubing to achieve the desired reflux. Therefore, a simpler and more compact solution is needed for flow reversal, which also includes the benefits of using flexible, disposable tubing. Summary of the Invention

[0006] In one embodiment, the valve assembly with multidirectional flow paths includes a valve body comprising corresponding hinged portions that, when the valve body is closed, define corresponding channels extending through the valve body. A flexible conduit or pipe having a loop portion and multiple branches extending from the loop portion is at least partially located within the valve body. In some embodiments, the loop portion is entirely contained within the valve body. For embodiments where the loop extends beyond the valve body, these portions are encapsulated by corresponding rigid sheaths. Multiple valves are located on the valve body and are used to selectively clamp the loop portion in different clamping configurations to direct fluid to or from a specific branch. The valve assembly can be integrated into a manufacturing process or other production process with optional additional sheaths used to encapsulate the flexible conduit branches.

[0007] In another embodiment, the valve assembly with a multidirectional flow path includes a valve body having a first body portion (e.g., one half) and a second body portion (e.g., one half) connected to each other at one or more hinges, the first and second body portions defining respective channels extending through the valve body when the valve body is closed. A flexible conduit is disposed in the channel of the valve body. The flexible conduit has a ring or ring portion connected to a first branch, a second branch, a third branch, and a fourth branch, wherein the second and fourth branches are fluidly connected to each other via a connector segment (serving as a bypass) across the ring portion. A first valve is disposed on the valve body and has an actuator configured to actuate a pinching element to clamp the ring of the flexible conduit between the first and second branches. A second valve is disposed on the valve body and has an actuator configured to actuate the pinching element to clamp the ring of the flexible conduit between the second and third branches. A third valve is disposed on the valve body and has an actuator configured to actuate the pinching element to clamp the ring of the flexible conduit between the third and fourth branches. A fourth valve is disposed on the valve body and has an actuator configured to actuate a clamping element to clamp a ring of the flexible conduit between the fourth branch and the first branch. A fifth valve is disposed on the valve body and has an actuator configured to actuate a clamping element to clamp the flexible conduit in a connector section (e.g., a bypass section). In this embodiment, a first portion of the ring extends outside the valve body and is contained within a first rigid sheath, and a second portion of the ring extends outside the valve body and is contained within a second rigid sheath. At least one fastener may be included on the valve assembly to secure the valve body in a closed state.

[0008] In another embodiment, the valve assembly with a multidirectional flow path includes a valve body having a first body portion (e.g., one half) and a second body portion (e.g., one half) connected to each other at one or more hinges, the first and second body portions defining respective channels extending through the valve body when the valve body is closed. A flexible conduit is disposed within the channel of the valve body. The flexible conduit has a ring or ring portion contained within the valve body and connected to a first branch, a second branch, a third branch, and a fourth branch, wherein the second and fourth branches are fluidly connected to each other via connector segments across the ring portion. A first valve is disposed on the valve body and has an actuator configured to actuate a clamping element to clamp the ring of the flexible conduit between the first and second branches. A second valve is disposed on the valve body and has an actuator configured to actuate a clamping element to clamp the ring of the flexible conduit between the first and second branches. A third valve is disposed on the valve body and has an actuator configured to actuate a clamping element to clamp the ring of the flexible conduit between the second and third branches. A fourth valve is disposed on the valve body and has an actuator configured to actuate a clamping element to clamp a ring of the flexible conduit between the second and third branches. A fifth valve is disposed on the valve body and has an actuator configured to actuate a clamping element to clamp a ring of the flexible conduit between the third and fourth branches. A sixth valve is disposed on the valve body and has an actuator configured to actuate a clamping element to clamp a ring of the flexible conduit between the third and fourth branches. A seventh valve is disposed on the valve body and has an actuator configured to actuate a clamping element to clamp a ring of the flexible conduit between the fourth and first branches. An eighth valve is disposed on the valve body and has an actuator configured to actuate a clamping element to clamp a ring of the flexible conduit between the fourth and first branches. A ninth valve is disposed on the valve body and has an actuator configured to actuate a clamping element to clamp a flexible conduit in a connector section (e.g., a bypass section). The valve assembly includes at least one fastener configured to secure the valve body in a closed state.

[0009] In another embodiment, the flexible conduit or pipe for use in a multidirectional flow path includes a ring having a first branch, a second branch, a third branch, and a fourth branch, wherein the second and fourth branches are fluidly connected to each other via connector segments across the ring portion, wherein the ring is formed by three (three) components joined at four (4) engagement locations. The engagement locations can be formed by overmolding (secondary molding) a connector, such as a foam connector, at the engagement locations. In one embodiment, the three (three) components include a central double-cross component that engages with two T-shaped members at the four (4) engagement locations.

[0010] In another embodiment, a method of manufacturing a flexible conduit having a ring portion includes the following steps or operations: providing a double cross-shaped conduit segment; providing a first T-shaped conduit segment and a second T-shaped conduit segment; securing one end of the first T-shaped conduit segment to the double cross-shaped conduit segment via a first overmolding connector; securing one end of the second T-shaped conduit segment to the double cross-shaped conduit segment via a second overmolding connector; securing the second end of the first T-shaped conduit segment to the double cross-shaped conduit segment via a third overmolding connector; and securing the second end of the second T-shaped conduit segment to the double cross-shaped conduit segment via a fourth overmolding connector. Attached Figure Description

[0011] Figure 1 A perspective view of a valve assembly according to one embodiment is shown.

[0012] Figure 2 It shows Figure 1 Bottom view of the valve assembly.

[0013] Figure 3 It shows Figure 1 A top view of the valve assembly.

[0014] Figure 4 It shows Figure 1 The bottom view of the valve assembly shows half of the valve body removed to reveal the flexible conduit within. The corresponding half of the rigid sheath has also been removed in this view.

[0015] Figure 5 It shows Figure 1 A perspective view of the valve assembly, with half of the valve body removed (and the flexible conduit removed).

[0016] Figure 6 It shows from Figure 5 Perspective view of the removed half.

[0017] Figure 7A A flexible catheter according to one embodiment is shown.

[0018] Figures 7B to 7F A method for manufacturing a flexible catheter having a ring portion therein is shown.

[0019] Figure 8 A rigid sheath according to one embodiment is shown.

[0020] Figure 9 This illustrates how the actuator and clamping element switch between closed and open states in response to the movement of the clamping element.

[0021] Figure 10 The diagram shows the piping and instrumentation used in conjunction with the valve assembly and chromatography column.

[0022] Figure 11 The diagram shows a valve assembly used in a representative high-pressure application, which utilizes multiple sheaths to encapsulate flexible conduits.

[0023] Figure 12A Another embodiment of a valve assembly is shown, in which the annular portion of a flexible conduit is completely encapsulated within the valve body. The valve body is shown in a closed state.

[0024] Figure 12B Another embodiment of a valve assembly is shown, in which the annular portion of a flexible conduit is completely encapsulated within the valve body. The valve body is shown in the open position. Detailed Implementation

[0025] Figures 1 to 10 An embodiment of a valve assembly 10 for generating a multidirectional flow path is shown. The valve assembly 10 includes a valve body 12, which includes components via one or more hinges 18 (see...). Figure 2 , Figure 3 , Figure 4 , Figure 5 , Figure 6 The valve body 12 consists of a first body portion 14 and a second body portion 16 connected to each other. The valve body 12 and the corresponding portions 14, 16 are typically made of a metallic material (e.g., stainless steel), but may also be formed of a suitable hard plastic material. When in the closed state, the first body portion 14 and the second body portion 16 define a channel 20 (in... Figure 5 and Figure 6 (Best viewed in the image), the channel 20 extends through the closed valve body 12 receiving the flexible conduit 70. In one embodiment, the cross-section of the channel 20 is substantially circular when the valve body 12 is closed. For example, the first body portion 14 may include a semi-annular or semi-circular channel formed in its surface that matches a corresponding semi-annular or semi-circular channel formed in the surface of the second body portion 16 to create an annular or circular channel 20. While a circular channel 20 is preferred, other shapes may also be used. The channel 20 is specifically arranged to accommodate the flexible conduit or conduit 70 placed therein. The channel 20 is sized and shaped such that the flexible conduit 70 is fitted therein. For example, the inner diameter of the channel 20 may closely match the outer diameter of the flexible conduit 20. The flexible conduit or conduit 70, as disclosed in more detail below, includes an annular portion 72 for creating a multidirectional flow path when used in combination with a series of valves as described herein. The flexible conduit 70 includes an inner lumen 71 (see... Figure 1 The fluid travels through the inner cavity 71.

[0026] One or more fasteners 22 can be used to secure the first body portion 14 and the second body portion 16 in a closed state. The fasteners 22 may include a pivot latch 24 having threads, on which a knob 26 is rotated to tighten and / or loosen the knob 26 to selectively close / open the valve body 12. The pivot latch 24 can be rotated into a slot 25, etc., located on the first body portion 14 and the second body portion 16 (see...). Figure 1 and Figure 5 The knob 26 is tightened to keep the valve body 12 in the closed position. Alternatively, the knob 26 can be loosened and the pivot latch 24 can be rotated out of the slot 25 to allow the valve body 12 to be opened via one or more hinges 18.

[0027] refer to Figures 1 to 4 and Figure 7A and Figure 7F In this embodiment, the flexible conduit 70 includes a ring portion 72 defining a circular fluid passage. In this embodiment, a first branch 74, a second branch 76, a third branch 78, and a fourth branch 80 are fluidly connected to the ring portion 72. The flexible conduit 70 includes a connector segment 82 fluidly connected to opposite sides of the ring portion 72. The connector segment 82 is used to form a bypass passage between the second branch 76 and the fourth branch 80. This connector segment 82 may be located between the second branch 76 and the fourth branch 80, but it may also be indirectly connected to the branches 76 and 80 via the ring. A key requirement is that the connector segment 82 is located within the ring portion 72, which is situated within the closure point described below.

[0028] The flexible conduit 70 is used to transport fluid through the valve assembly 10. In the illustrated embodiment, the flexible conduit 70 transports pressurized fluid, such as fluid at a pressure above 50 psig. The flexible conduit 70 may comprise silicone (e.g., platinum-cured silicone), however other materials may be used. These materials include, for example, polymers such as thermoplastic elastomers (TPE), thermoplastic rubbers (TPR), etc. The flexible conduit 70 may be unreinforced as shown, or in some embodiments it may be reinforced. The embodiments described herein are particularly suitable for unreinforced flexible conduits 70. The flexible conduit 70 may have various sizes. For example, without limiting the invention, the flexible conduit 70 may have an inner diameter of 0.5 inches and an outer diameter of 0.75 inches. Of course, this is merely illustrative, and other diameters may be used.

[0029] exist Figure 7AIn the diagram, the ends of the first branch 74, the second branch 76, the third branch 78, and the fourth branch 80 are shown as relatively short segments; however, it should be understood that these branches 74, 76, 78, and 80 can be longer (or shorter). Additionally, the ends of branches 74, 76, 78, and 80 may terminate in flanges or the like, so that another segment (not shown) can be coupled to the ends of branches 74, 76, 78, and 80 using connectors or the like. The first branch 74, the second branch 76, the third branch 78, and the fourth branch 80 may extend beyond the valve assembly 10 by a certain distance and may be encapsulated or surrounded in one or more sheaths 120, such as... Figure 11 As shown in the diagram. The sheath 120 may comprise a two-piece sheath attached to each other via hinges or the like. The sheath 120 may enclose the flexible conduit or pipe 70 and be secured in a closed state using one or more fasteners (such as those disclosed herein) to prevent the flexible conduit 70 from expanding and failing under high fluid pressure. The sheath 120 may also be used to guide the flexible conduit or pipe 70 to adjacent components or operations that are part of the manufacturing process. The sheath 120 provides the ability to guide the flexible conduit or pipe 70 in three-dimensional space to orderly arrange and manage the manufacturing or production processes using the flexible conduit or pipe 70.

[0030] refer to Figures 7A to 7F In one embodiment, the loop portion 72 of the flexible catheter 70 can be formed by connecting multiple different segments of the flexible catheter 70 to form Figure 7A The final structure is shown in the figure. In this example, three different components or portions of the flexible conduit 70 are bonded or otherwise secured to each other during molding to form a complete ring portion 72. For example, in one embodiment, overmolded foam connectors 88a, 88b, 88c, 88d can be used to bond the double-ten field 84 to the two “Y” or T-shaped segments 86’, 86”, and the overmolded foam connectors 88a, 88b, 88c, 88d connect the respective ends of the T-shaped segments 86’, 86” to the double-ten field 84 formed during the formation of the flexible conduit 70. In this embodiment, there are four (4) engagement locations formed where the two Y or T-shaped segments 86’, 86” are secured to the ends of the ten field 84 (i.e., foam connectors 88a, 88b, 88c, 88d). Note that in other embodiments, the ring or ring portion 72 may have additional branches formed beyond the four branches 74, 76, 78, 80 shown.

[0031] To form a flexible catheter 70 with a ring portion 72, the first Y or T-shaped segment 86' is fixed to the double-ten field 84, such as Figure 7BAs shown in the diagram. The insert mandrel 90, as shown, can be a metal shaft or the like with an outer diameter approximately the same as the inner diameter of the flexible conduit forming the double-ten field 84 and the Y or T segment 86'. The connecting structure is then placed in a mold (not shown), the mold including a cavity defining a foam connector 88a. A polymeric material, such as silicone, is then injected into the mold and cured (e.g., platinum curing) to form the foam connector 88a at the interface between the first Y or T segment 86' and the double-ten field 84. This can then be achieved by... Figure 7B In the direction of arrow A, pull the mandrel 90 out of the now-formed structure to remove the mandrel 90. Next, refer to... Figure 7C Secure the second Y or T segment 86” to the double ten field 84. Insert the mandrel 90 into the second Y or T segment 86” and the double ten field 84. Then, as previously described, place the connecting structure into the mold, wherein a foam connector 88b is formed around the joint between the second Y or T segment 86” and the double ten field 84, as shown. Figure 7C As shown in the diagram. After curing, the mandrel 90 is removed by pulling it in the direction of arrow B.

[0032] Next, refer to Figure 7D The mandrel 90 is positioned within one segment or leg of the first Y- or T-shaped segment 86' and the double-ten field 84, as shown. The connecting structure is then placed into the mold as previously described, wherein a foam connector 88c is formed around the joint between the second Y- or T-shaped segment 86' and the double-ten field 84, as shown. Figure 7C As shown in the diagram. After curing, mandrel 90 is removed by pulling it in the direction of arrow C. Reference Figure 7E Then, the mandrel 90 is positioned within the remaining segment or leg of the second Y or T segment 86” and the double ten field 84, as shown. The connecting structure is then placed into the mold as previously described, wherein a foam connector 88d is formed around the joint between the second Y or T segment 86” and the double ten field 84. After curing, the mandrel 90 is removed by pulling it in the direction of arrow D. Note that, alternatively, the segment or leg of the second Y or T segment 86” may be connected to the double ten field 84 before connecting the segment or leg of the first Y or T segment 86” to the double ten field 84.

[0033] Figure 7FA view of the complete flexible conduit 70 with an annular portion 72 is shown. Note the four branches 74, 76, 78, 80, or ends extending from the annular portion 72. These branches 74, 76, 78, 80 may have various lengths. Additionally, the branches 74, 76, 78, 80 of the flexible conduit 70 may have one or more additional optional ends or connectors (not shown). These can be added via another molding operation. These may include extensions of: transparent tubing, braided hose, hose barbs, or molded triple clamping washers.

[0034] A significant advantage of manufacturing the flexible conduit 70 with the ring portion 72 in this manner is that the valve closure points 92a, 92b, 92c, 92d, 92e, 92f, 92g, 92h, and 92i can be located at positions that eliminate or significantly reduce the retaining volume of any ring portion 72. Other manufacturing methods use large or bulbous overmolded connectors between various intersecting pathways. The valve closure points 92a, 92b, 92c, 92d, 92e, 92f, 92g, 92h, and 92i cannot be located where these larger overmolded features would be. Conversely, as in Figure 7F As seen in the diagram, valve closure points 92a, 92b, 92c, 92d, 92e, 92f, 92g, 92h, and 92i can be located very close to intersecting fluid passages. Importantly, these valve closure points 92a, 92b, 92c, 92d, 92e, 92f, 92g, 92h, and 92i are all located in positions where there is a naturally flexible conduit 70 that is not covered or obstructed by any overmolded or other bulky connecting material.

[0035] Preferably, the closure points 92a, 92b, 92c, 92d, 92e, 92f, 92g, 92h, and 92i are less than 1 cm away from intersecting or adjacent flow paths or fluid passages. Even more preferably, the closure points 92a, 92b, 92c, 92d, 92e, 92f, 92g, 92h, and 92i are located as close as possible to intersecting or adjacent flow paths or fluid passages, without encroaching upon or adversely affecting another flow path or fluid passage. For example, as in... Figure 7F As seen, there are four (4) valve closure points 92a, 92b, 92c, and 92d, which are generated directly adjacent to the crossflow paths of the double-ten field 84. The closure of these valve closure points 92a, 92b, 92c, and 92d prevents valuable reagents or products from remaining in the legs or segments of the double-ten field 84 or the first or second Y or T-shaped segments 86', 86'. For example, for... Figures 1 to 6The valve assembly 10 shown has five (5) valves, which are positioned to produce closure points 92a, 92b, 92c, 92d, and 92e, which are located close to the bypass passage formed between branches 76, 80 and connector segment 82.

[0036] It may also have additional valve closing points 92f, 92g, 92h, 92i, such as Figure 7F As shown in [the document]. For example, in [the document]. Figure 7F In the middle, there are four (4) additional valve closure points 92f, 92g, 92h, 92i located near the legs or segments of the Y or T-shaped sections 86', 86" . These valve closure points 92f, 92g, 92h, 92i prevent fluid from being retained from branches 74, 78. For example, in the use of nine (9) valves Figure 12A and Figure 12B These additional closure points 92f, 92g, 92h, and 92i are used in the valve assembly. This minimizes or even eliminates the characteristic of the holding volume with the ring portion 72, which is particularly important for pharmaceutical and biopharmaceutical applications where even small quantities of drug or product can represent significant sums. Furthermore, the holding volume region can contain residual fluids and / or reagents, which can contaminate or adversely affect other processes occurring during manufacturing operations. These could, for example, affect product yield.

[0037] refer to Figures 1 to 4 and Figure 8 In one embodiment, the valve assembly 10 includes a rigid sheath 30 that encapsulates portions of a flexible conduit 70. Specifically, the rigid sheath 30 encapsulates portions of annular portions 72 extending outside the valve body 12. Each sheath 30 includes a first half 32 and a second half 34, which are connected to each other via one or more hinges 36. Similar to the valve body 12, when the first half 32 and the second half 34 of the sheath 30 are closed, channels 38 are formed within the sheath 30 to transport portions of the flexible conduit 70. These channels 38 are sized to accommodate the flexible conduit 70 (e.g., circular when fully closed). The first half 32 and the second half 34 of each sheath 30 include semi-annular or semi-circular grooves that, when together in a closed state, form a circular or annular channel 38 accommodating the flexible conduit 70. The channels 38 are sized such that the flexible conduit 70 is held securely within them, much like the valve body 12.

[0038] In one aspect, the sheath 30 is formed of a rigid, polymer-based material. These include, for example, polymeric materials such as acrylonitrile butadiene styrene (ABS) or other engineering thermoplastics suitable for the environment or application. Examples include standard thermoplastics and polyolefins such as polyethylene (PE) and polypropylene (PP), polyetherimide (PEI) (e.g., ULTEM resin), aliphatic polyamides (e.g., nylon), polyphenylene sulfone (e.g., RADEL), fluoropolymers such as polyvinylidene fluoride (PVDF) or perfluoroalkoxy (PFA), polytetrafluoroethylene (PTFE), polycarbonate (which may be more heat-resistant), and polysulfone (PSU). Of course, the sheath 30 may also be made of a metallic material (e.g., stainless steel).

[0039] In one embodiment, the sheath 30 is received or held in a closed state by the valve body 12. Specifically, as in Figure 5 and Figure 6 As seen in the diagram, the first body portion 14 and the second body portion 16 may include recesses 40 formed therein that receive the ends of the sheath 30, thereby sealing the outer periphery of the sheath 30 when the valve body 12 is in the closed state. Alternatively, the sheath 30 may be held closed by one or more fasteners, such as the fastener 22 described herein. Friction fits / press fits or similar techniques may also be used to hold the sheath 30 together. In other embodiments, the ends of the sheath 30 may include flange ends, etc., configured to engage with a corresponding receiving portion on the valve body 12 (or vice versa). These may include shoulders or grooves formed in the recesses 40, sized to receive and receive the flange ends. The ends of the sheath 30 may include one or more protrusions, such as posts 31, that insert into holes or bores 13 in the valve body 12, as in Figure 5 , Figure 6 and Figure 8 As shown, this helps to secure the sheath 30 relative to the valve body 12.

[0040] In yet another embodiment, the sheath 30 may not be in contact with the interior of the valve body 12 and may only abut against its outer surface (or be located near the edge of the valve body 12). In still another embodiment, the sheath 30 may be omitted entirely, and the valve body 12 may be made larger to accommodate the entire annular portion 72 of the flexible conduit 70. Figure 12A and Figure 12B This embodiment is shown in the figure.

[0041] Return to reference Figure 1In this particular embodiment, five (5) individual valves 50, 52, 54, 56, and 58 are secured to a first body portion 14 of the valve body 12. These valves are referred to as first valve 50, second valve 52, third valve 54, fourth valve 56, and fifth valve 58. Although valves 50, 52, 54, 56, and 58 are shown as being secured to the first body portion 14, they may also be secured to a second body portion 16, or they may be located on both portions 12 and 14 (e.g., to provide greater space between the valves). As illustrated herein, valves 50, 52, 54, 56, and 58 are used to selectively clamp a flexible conduit 70 contained within the valve body 12. In the illustrated embodiment, a clamp 60 is used to secure each valve 50, 52, 54, 56, and 58 to the valve body 12; although the clamp 60 is optional, in some other embodiments, valves 50, 52, 54, 56, and 58 may be directly secured to the valve body 12.

[0042] Each valve 50, 52, 54, 56, 58 includes an actuator 62, which is included in arrow A ( Figure 9 The clamping element 64 moves in the direction of the flexible conduit 70 to selectively close / open the central cavity 71. The actuator 62 can be moved using any number of methods. For example, the actuator 62 can be a pneumatically actuated valve using an air port 66 (connected to an air line; not shown). The actuator 62 can also be manually forward / retracted using a rotated valve cap, etc. The actuator 62 can also be actuated using a manually activated toggle-type mechanism that does not require rotation of the valve cap, etc. This allows for rapid switching between open / closed states of the valve. The actuator 62 can also be actuated using an electric drive motor or servo. Typically, valves 50, 52, 54, 56, and 58 are automatically controlled using valve electronics to control their open / closed states. For example, a solenoid located in a separate control panel assembly (not shown) is used to control the airflow to the air port 66 to turn valves 50, 52, 54, 56, and 58 on / off.

[0043] refer to Figure 4 , Figure 5 and Figure 10 The first valve 50 is actuated by a clamping element 64 passing through a hole 65 located in the first valve body portion 14 to clamp the flexible conduit 70 at the closure point #1, as in Figure 4As seen in the diagram. Closure point #1 is located between the first branch 74 and the second branch 76. The second valve 52 is actuated through the clamping element 64 located in the hole 65 in the first valve body portion 14 to clamp the flexible conduit 70 at closure point #2. Closure point #2 is located between the second branch 76 and the third branch 78. The third valve 54 is actuated through the clamping element 64 located in the hole 65 in the first valve body portion 14 to clamp the flexible conduit 70 at closure point #3. Closure point #3 is located between the third branch 78 and the fourth branch 80. The fourth valve 56 is actuated through the clamping element 64 located in the hole 65 in the first body portion 14 to clamp the flexible conduit 70 at closure point #4. Closure point #4 is located between the fourth branch 80 and the first branch 74. The fifth valve 58 is actuated through the clamping element 64 located in the hole 65 in the first body portion 14 to clamp the flexible conduit 70 at closure point #5. Closure point #5 is located in the connector section 82.

[0044] Figure 10 A piping and instrumentation diagram is shown for the combination of valve assembly 10 and chromatography column 100. In this embodiment, chromatography column 100 can operate in either co-current or reflux mode. (See reference...) Figure 1 The valve assembly 10 has a first branch 74 of the flexible conduit 70 connected to the inlet port of the chromatography column 100. A third branch 78 of the flexible conduit 70 is connected to the outlet port of the chromatography column 100. Fluid from drug handling or bioprocess handling (e.g., feed pumps and upstream instruments) enters the valve assembly 10 via a second branch 76 of the flexible conduit 70 and flows through a fourth branch 80 of the flexible conduit 70 (downstream (outflow) instrument) (see...). Figure 2 ) Exit valve assembly 10. In Figure 10 In the diagram, PY-001, PY-002, PY-003, PY-004, and PY-005 show the solenoid valves associated with each of valves 50, 52, 54, 56, and 58.

[0045] During the operation of the chromatography column 100 in a co-current manner, such as during column packing or normal capture mode, valves 50, 52, 54, 56, and 58 are in an open / closed state according to Table 1 below.

[0046] Table 1 - Downstream

[0047]

[0048] During the operation of the chromatography column 100 using reflux, such as during column cleaning or expanded bed treatment, valves 50, 52, 54, 56, and 58 are in the open / closed state according to Table 2 below.

[0049] Table 2 - Reflux

[0050]

[0051] During operations that require bypassing the chromatography column 100, valves 50, 52, 54, 56, and 58 are in an open / closed state according to Table 3 below.

[0052] Table 3 - Bypass Flow

[0053]

[0054] Figure 11 A valve assembly 10 used in a representative high-pressure process is shown. In this embodiment, the flexible conduit 70 located outside the valve assembly 10 is itself surrounded by a separate sheath 120. The sheath 120 may be formed of a first half and a second half, which surround the flexible conduit 70 and can be locked in place using fasteners (such as those described herein with respect to valve assembly 10), press-fit arrangements, etc. The sheath 120 may be made of a suitable rigid material, such as metal or polymeric material (such as those described herein), to serve as an exoskeleton-type structure, thereby containing the flexible conduit 70 and preventing “aneurysm”-like failure of the flexible conduit 70 in response to the transport of high-pressure fluid. The sheath 120 may be modular and interconnected (or connected to other processing components) so that there is no exposed area of ​​the flexible conduit 70. Clamp 122 (in Figure 11 The diagram shows one that can be used to connect adjacent sheaths 120, or sheaths 120 may include fittings for connecting various components. Sheaths 120 may have many sizes and shapes to arrange the flexible conduits 70 in an orderly manner according to the process in which the sheaths are used.

[0055] Figure 12A and Figure 12B Another embodiment of the valve assembly 200 is shown. In this embodiment, the valve assembly 200 includes a valve body 202, which includes a first body portion 204 and a second body portion 206, the first body portion 204 and the second body portion 206 being connected to each other via one or more hinges 208. The valve body 202 and the corresponding portions 204, 206 are typically made of a metallic material (e.g., stainless steel), but they may also be formed of a suitable rigid plastic material. In this embodiment, the entire annular portion 72 of the flexible conduit 70 ( Figure 12BThe flexible conduit 70 is contained within the valve body 202. Therefore, in this embodiment, there is no rigid sheath for encapsulating the annular portion 72 of the flexible conduit 70. In this embodiment, the inward-facing surfaces of the first body portion 204 and the second body portion 206 each define a corresponding semi-annular or semi-circular channel that, when together in the closed state, defines a channel 209 (e.g., a circular channel) for retaining the annular portion 72 of the flexible conduit 70. The valve body 202 can be secured in the closed state using one or more fasteners 210, as described herein. The fastener 210 may include a pivot latch 212 having threads, on which a knob 214 is rotated to tighten and / or loosen the knob 214 to selectively close / open the valve body 202. The pivot latch 212 can be rotated into a notch 216 located on the first body portion 204 and the second body portion 206. Figure 12B In the case of valve body 202, the knob 214 is tightened to keep the valve body 202 in the closed position. Alternatively, the knob 214 can be loosened and the pivot latch 212 can be rotated out of the slot 216 to allow the valve body 202 to be opened via one or more hinges 208.

[0056] In this embodiment, there are nine individual valves 220, 222, 224, 226, 228, 230, 232, 234, and 236 fixed to the valve body 202. In the illustrated embodiment, five of these valves 220, 222, 224, 226, and 228 are fixed to the first body portion 204, while the remaining four valves 230, 232, 234, and 236 are fixed to the second body portion 206. Each valve 220, 222, 224, 226, 228, 230, 232, 234, and 236 is fixed to the valve body 202 via a clamp 238. Although the clamp 238 is optional, in some other embodiments, the valves 220, 222, 224, 226, 228, 230, 232, 234, and 236 may be directly fixed to the valve body 12. Valves 220, 222, 224, 226, 228, 230, 232, 234, and 236 can be any type of valve as described herein, and each valve is used to selectively clamp the flexible conduit 70 contained within the valve body 202. Each valve 220, 222, 224, 226, 228, 230, 232, 234, and 236 includes an actuator and clamping element (not shown) as previously described in previous embodiments herein to selectively close / open the central cavity 71 of the flexible conduit 70.

[0057] In this embodiment, valves 220, 222, 224, 226, 228, 230, 232, 234, and 236 are positioned to provide, for example, Figure 7FThe closure points are shown in the diagram. Therefore, in this embodiment, by placing the closure points 92a, 92b, 92c, 92d, 92e, 92f, 92g, 92h, and 92i near the intersecting flow paths in the annular portion 72 of the flexible conduit 70, the volume that may be retained in the double-ten field 84 or the legs or segments of the first or second Y or T-shaped segments 86', 86" is reduced or eliminated, such as... Figure 7F The volumes 92f-92b, 92h-92a, 92i-92c, 92d-92g between the closure points are shown in the diagram. Further, in this embodiment, valves 220, 222, 224, 226, 228, 230, 232, 234, and 236 are positioned on both sides of the valve body 202, providing sufficient space to install all nine valves. In this embodiment, two valves 228 and 232 can be closed to isolate the flow path between the first branch 74 and the second branch 76. Two more valves 222 and 230 can be closed to isolate the flow path between the second branch 76 and the third branch 78. Two more valves 220 and 234 can be closed to isolate the flow path between the third branch 78 and the fourth branch 80. Two additional valves 226 and 236 can be closed to isolate the flow path between the fourth branch 80 and the first branch 74. A single valve 224 is used to close the flow path in connector section 82 (e.g., bypass passage).

[0058] One advantage of the valve assemblies 10, 200 described herein is their relatively compact design, allowing for manual positioning, opening, and closing without the need for complex installation structures or tools. Furthermore, valve assemblies 10, 200 allow for the rapid replacement of the flexible conduit 70 with another alternative. In applications requiring sterilization or aseptic conditions, the new flexible conduit 70 can be used to replace the old one. This can be done quickly by using fasteners 22, 210 to open valve assemblies 10, 200, removing the old or disposable flexible conduit 70, inserting the new flexible conduit 70, and closing valve assemblies 10, 200 using fasteners 22, 210. In addition to their relatively compact design, valve assemblies 10, 200 can optionally be used with an additional sheath 120, which can be used to guide and manage the flexible conduit 70 in multiple dimensions to other processing units or components.

[0059] Although embodiments of the invention have been shown and described, various modifications can be made without departing from the scope of the invention. For example, although valve assemblies 10, 200 have been described as being used in conjunction with a chromatography column, valve assemblies 10, 200 can be used in any application requiring reflux and bypass flow. As another example, although the flexible conduit 70 including the ring portion 72 is shown as having four branches 74, 76, 78, 80, it can have more branches coupled to the ring portion 72. In this configuration, an additional valve will be added to the valve assembly. Furthermore, although... Figure 12A and Figure 12B An embodiment of nine (9) valves is shown where the entire ring portion 72 is included in the valve body 202, but it is also possible to construct... Figures 1 to 6 An embodiment of five (5) valves is provided, such that the entire ring portion 72 is within the valve body 12, thereby eliminating the rigid sheath 30. Furthermore, it should be understood that while various embodiments are described herein, various features of one embodiment may be combined or used together with another embodiment. That is, features of one embodiment may be substituted or used in another embodiment. Therefore, the invention is not limited except by the following claims and their equivalents.

Claims

1. A valve assembly having a multidirectional flow path, comprising: A valve body includes a first body portion and a second body portion connected to each other at one or more hinges, wherein when the valve body is in a closed state, the first body portion and the second body portion define a passage extending through the valve body; A flexible conduit, at least a portion of which extends through a channel in the valve body, the flexible conduit comprising: The first branch includes the first T-shaped segment; Second branch; The third branch includes the second T-shaped segment; The fourth branch; and The connector segment is located between the second and fourth branches; The ring portion is connected to the first T-shaped segment of the first branch via first and second overmolded connectors, and to the second T-shaped segment of the third branch via third and fourth overmolded connectors; Multiple valves are disposed on a valve body, each of the multiple valves including an associated clamping element; and A plurality of actuators, associated with the plurality of valves, the plurality of actuators being configured to actuate a clamping element associated with each of the plurality of valves to move the clamping element through a corresponding hole in a first or second body portion and into one of the channels; in: The plurality of valves include: a first valve including a first actuator associated with a first clamping element; a second valve including a second actuator associated with a second clamping element; a third valve including a third actuator associated with a third clamping element; a fourth valve including a fourth actuator associated with a fourth clamping element; and a fifth valve including a fifth actuator associated with a fifth clamping element. The first clamping element is configured to clamp the flexible catheter loop between the first branch and the second branch at a position on the flexible catheter located between the first overmolded connector and the third overmolded connector. The second clamping element is configured to clamp the flexible conduit ring between the second branch and the third branch at a position on the flexible conduit located between the first overmolded connector and the third overmolded connector. The third clamping element is configured to clamp the flexible catheter ring between the third branch and the fourth branch at a position on the flexible catheter located between the second overmolded connector and the fourth overmolded connector. The fourth clamping element is configured to clamp the flexible catheter ring between the fourth branch and the first branch at a position on the flexible catheter located between the second overmolded connector and the fourth overmolded connector; and The fifth clamping element is configured to clamp the flexible conduit in the connector segment. The first, second, third, and fourth valves are positioned less than 1 cm away from adjacent intersections or adjacent flow paths or fluid passages to minimize any retention volume of fluid within the loop.

2. The valve assembly according to claim 1, wherein, The plurality of valves are disposed on the first body portion.

3. The valve assembly according to claim 1, wherein, At least one of the plurality of valves is disposed on the first body portion, and at least one of the plurality of valves is disposed on the second body portion.

4. The valve assembly according to claim 1, wherein, The actuator is manually actuable.

5. The valve assembly according to claim 1, wherein, The actuator is capable of automatic actuation.

6. The valve assembly according to claim 1, wherein, A first portion of the ring extends outside the valve body and is contained within a first rigid sheath, and a second portion of the ring extends outside the valve body and is contained within a second rigid sheath, the first and second rigid sheaths being configured to receive a flexible conduit.

7. The valve assembly according to claim 6, wherein, The valve body comprises a metallic material, and the first and second rigid sheaths comprise a polymer material.

8. The valve assembly according to claim 6, wherein, The first and second rigid sheaths include hinged sheaths.

9. The valve assembly according to claim 6, wherein, The first rigid sheath and the second rigid sheath each include a corresponding half that is fastened to each other by fasteners.

10. The valve assembly according to claim 6, wherein, The first rigid sleeve and the second rigid sleeve are fixed in corresponding grooves formed in the first body portion and the second body portion of the valve body.

11. The valve assembly of claim 6, wherein, The first and second rigid sheaths each include a corresponding post that extends into a corresponding hole or cavity formed in at least one of the first and second body portions of the valve body.

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