Sterile fluid coupling

Abstract

Some of the fluid coupling devices described herein are configured for use in a fluid system for the purpose of providing a single use sterile disconnect function that substantially prevents fluid overflow when disconnected. In some embodiments, the coupler portions cannot be functionally reconnected to each other after being disconnected from each other.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 344,786, filed May 23, 2022. The disclosure of the prior application is considered part of (and incorporated by reference into) the disclosure of the present application. Technical Field

[0003] This document relates to fluid coupling devices for use in fluid systems and methods.For example, some embodiments described herein relate to single-use aseptic disconnect fluid coupling devices. Background Art

[0004] Fluid systems typically include components such as pipes, pumps, reservoirs, fittings, couplings, heat exchangers, sensors, filters, valves, seals, etc. Such components may be connected together in a network to define one or more fluid flow paths.

[0005] Fluids can be moved through a fluid system using a fluid pressure differential. For example, in some cases, a pump or vacuum source is used to create a pressure differential that causes fluid to flow within a fluid system. In another example, gravity is used to cause fluid to flow within a fluid system. In other examples, mechanical equipment can be used to apply an external force on a tube or reservoir, thereby causing fluid to flow. A peristaltic pump is an example. In other examples, a combination of such technologies is used to cause fluid to flow within a fluid system.

[0006] Some fluid couplings can be used for sterile fluid delivery, for example, for connecting the source of one or more sterile components to a sterilization treatment system, such as a bioreactor or other type of sterilization system or container. Fluid couplings for sterile fluid delivery can also be used to extract samples from a sterilization treatment system. Fluid couplings for sterile fluid delivery can also be used to connect two or more sterilization treatment equipment together.

[0007] In the context of some fluid systems (such as some bioprocessing fluid systems), it may be desirable to have a pipe coupling that can aseptically disconnect a fluid flow path. In such an exemplary embodiment, it is desirable to aseptically disconnect one or more containers (e.g., culture medium bags) from a bioreactor system. In this case, an aseptic coupling can be used to disconnect a container from a bioreactor system, while substantially preventing the biological contamination of the disconnected end of a container, pipeline, other connected parts, and a bioreactor via a coupling during and after the disconnection process. This aseptic connection will also be used to limit fluid exposure to the surrounding environment. Summary of the invention

[0008] Fluid coupling devices for fluid systems and methods are described herein. In some embodiments, the fluid coupling device can be implemented as a single-use sterile disconnect fluid coupling device, which is configured to reduce the possibility of fluid spillage when disconnected. In some embodiments, the coupling parts cannot be reconnected to each other (or to other coupling parts) after being disconnected from each other. Therefore, the fluid coupling device is referred to as a "single-use" sterile disconnect coupling.

[0009] In the context of the present disclosure, the term "fluid" refers to any substance that can flow, including but not limited to liquids, gases, granular or powdered solids, mixtures or emulsions of two or more fluids, suspensions of solids in liquids or gases, vapor, steam, mist, gel, semisolids, etc.

[0010] In certain embodiments, the fluid coupling devices described herein are disposable devices because the fluid path of one or both parts is irreversibly blocked after the two parts of the coupling (also referred to herein as "coupling halves," "connectors," or "bodies" and "inserts") are disconnected from each other. Thus, in these certain embodiments, the fluid coupling devices provided herein are structurally configured as single-use disconnect devices such that after the single-use coupling halves have been disconnected from each other, they cannot be operably reconnected to each other (or to any other coupling halves) to reestablish an open fluid flow path therethrough, and / or cannot be mechanically reconnected to each other.

[0011] In addition, in this single-use embodiment or in other embodiments, the fluid coupling device can be constructed as a "sterile" coupling device, because during disconnection and after the two parts of the coupling device are disconnected from each other, the fluid path of the two parts is mechanically blocked, for example, by a valve, so as to inhibit biological contamination from migrating into the flow path. In some such embodiments, the mechanical blocking of the fluid path is irreversible, for example, the valve cannot be opened by reversing the action taken during the disconnection process. This "sterile" coupling will also be used to limit fluid exposure to the surrounding environment. As used herein, the term "sterile" refers to any process or device that maintains a sterilized surface or volume. As used herein, "sterile" refers to being free of bacteria or other live microorganisms, or having bacteria or other live microorganisms below a specific level.

[0012] In addition, in such single-use embodiments or other embodiments, the fluid coupling device can be constructed as a spill-free coupling device because when the two parts of the coupling device are disconnected from each other, one or more mechanical components will reduce the likelihood of fluid exhausting the fluid system (e.g., by blocking such exhaust path), and / or prevent spills by limiting fluid inclusion caused when the coupling is used and / or when the couplings are connected to each other.

[0013] Specific embodiments of the subject matter described herein can be implemented to achieve one or more of the following advantages. First, the coupling halves of the fluid coupling device provided herein are designed so that the separation process involves closing the valves in a specific order, thereby eliminating or minimizing the spillage (discharge) of the fluid (i.e., non-spillage disconnection capability). Accordingly, contamination of the surrounding environment can be prevented.

[0014] Second, in some embodiments, the fluid coupling device is designed for use with relatively large pipes (e.g., 1 / 4 inch and larger diameters, 3 / 4 inch and larger sanitary fittings, etc.) and provides flow characteristics consistent with such large diameter pipes.

[0015] Third, some embodiments of the fluid coupling device provide improved aseptic disconnect capabilities, which in some cases can optionally reduce or eliminate the need for a sterile room or sterile bench environment. Therefore, these embodiments of the aseptic fluid coupling device described herein can promote efficient and cost-effective operations or uses that would otherwise be costly or even cost-prohibitive in some traditional settings that require disconnecting specific fluid couplings in a sterile room or sterile flow hood to prevent biological contamination.

[0016] Fourth, some embodiments of the fluid coupling devices provided herein are advantageously designed as single-use couplings that cannot be operably reconnected to reestablish an open flow path therethrough, thereby preventing the possibility of contamination from repeated use.

[0017] Fifth, some embodiments of the fluid coupling devices provided herein include a metal-free fluid flow path. In addition, some embodiments of the fluid coupling devices provided herein do not include any metal. In other words, the fluid coupling devices are completely metal-free.

[0018] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. In addition, the materials, methods, and examples of the embodiments described herein are illustrative only and not limiting.

[0019] The details of one or more embodiments of the invention are set forth in the drawings and the description herein. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a schematic diagram of a fluid system using an exemplary fluid coupling system according to some embodiments described herein.

[0021] Figure 2 yes Figure 1A perspective view of a fluid connection system.

[0022] Figure 3 is in an operational configuration Figure 1 Longitudinal cross-sectional view of a fluid connection system.

[0023] Figure 4 is configured to be in the first disconnection stage Figure 1 A perspective view of a fluid connection system.

[0024] Figure 5 Yes Figure 4 A longitudinal cross-sectional view of a fluid connection system constructed in FIG.

[0025] Figure 6 is configured to be in the second disconnection stage Figure 1 A perspective view of a fluid connection system.

[0026] Figure 7 Yes Figure 6 A longitudinal cross-sectional view of a fluid connection system constructed in FIG.

[0027] Figure 8 is constructed to be in the third disconnection stage Figure 1 A perspective view of a fluid connection system.

[0028] Fig. 9 Yes Figure 8 A longitudinal cross-sectional view of a fluid connection system constructed in FIG.

[0029] Fig.10 is constructed to be in the fourth and final stage of disconnection Figure 1 A perspective view of a fluid connection system.

[0030] Fig.11 Yes Fig.10 A longitudinal cross-sectional view of a fluid connection system constructed in FIG.

[0031] Fig.12 and Fig.13 Shows Figure 1 Various views of a shell body component of a fluid coupling system.

[0032] Figure 14-16 Shows Figure 1 Various views of the main valve components of the fluid coupling system.

[0033] Figure 17-19 Shows Figure 1 Various views of an insert valve component of a fluid coupling system.

[0034] Figure 20-23 Shows Figure 1 Various views of the body valve gasket of a fluid coupling system.

[0035] Figure 24-26 Shows Figure 1 Various views of the shuttle component of a fluid coupling system.

[0036] Figure 27-29 Shows Figure 1 Various views of an insert housing body member of a fluid coupling system.

[0037] Figure 30-32 Shows Figure 1 Various views of an insert terminal component of a fluid coupling system.

[0038] Figure 33-35 Shows Figure 1 Various views of the main housing body of a fluid coupling system.

[0039] Figure 36-38 Show Figure 1 Various views of the main terminal components of the fluid coupling system.

[0040] Fig.39 is a perspective view of another example fluid coupling system according to some embodiments described herein.

[0041] Fig.40 and 41 Shows Fig.39 Various views of example shell components of a fluid coupling system.

[0042] Fig.42 and 43 Shows Fig.39 Various views of an example retainer clamp component of a fluid coupling system.

[0043] Fig.44 and 45 Shows Fig.39 Various views of another example retainer clip component of a fluid coupling system.

[0044] Fig.46 Shows Fig.39 A perspective view of another example retainer clip component of a fluid coupling system.

[0045] Fig.47 Show Fig.46 A cross-sectional view of a retainer clip assembly.

[0046] Fig.48 Shows Fig.39 A side view of an example insert housing and terminal of a fluid coupling system.

[0047] Fig.49 Shows Fig.48Cross-sectional view of the insert housing and terminal piece.

[0048] Like reference numerals designate corresponding parts throughout. DETAILED DESCRIPTION

[0049] refer to Figure 1-3 , some example embodiments of the fluid system 10 include an example fluid coupling assembly 100 that is configured, for example, to releasably connect a first fluid system device or container 20 to a second fluid system device or container 30. In some embodiments, the fluid system 10 may include at least one fluid coupling assembly 100 that is a single-use sterile disconnect fluid coupling device. The fluid coupling assembly 100 (or more simply, "fluid coupling 100") defines a longitudinal axis 102 ( Figure 1 and Figure 2 ), and an open fluid flow path 103 ( Figure 3 ). The depicted configuration of the fluid coupling assembly 100 where there is an open fluid flow path 103 is also referred to herein as an "open configuration" or an "operable configuration."

[0050] In one non-limiting example, the fluid connector 100 can provide a single-use sterile disconnect capability for a fluid path between a fluid system device 20 in the form of a bioreactor system (directly connected to the coupling device 100 or connected via a fluid tube 22) and a fluid system container 30 in the form of a culture medium bag (directly connected to the coupling device 100 or connected via a fluid tube 32).

[0051] In the depicted embodiment, the fluid coupling assembly 100 includes a first coupling 200 and a second coupling 300. After the fluid transfer function of the fluid coupling assembly 100 has been used, the fluid coupling assembly 100 can be disconnected. That is, the user can disconnect the fluid coupling assembly 100 by separating the first coupling 200 and the second coupling 300 according to a prescribed technique (e.g., see Figures 4 to 11 ). This systematic disconnection process is described in further detail below.

[0052] The first coupling 200 and the second coupling 300 are configured to disconnect from each other in a manner that provides sterile disconnection and mechanically prevents the fluid flow path 103 from being reconnected and reused by the first coupling 200 and the second coupling 300. As used herein, the term "sterile" refers to any process that maintains a sterile surface or volume. The first coupling 200 and the second coupling 300 are sometimes referred to as "a plurality of coupling halves" or "coupling halves" in this article, even though the first coupling 200 and the second coupling 300 are not necessarily equal halves in size, shape, weight, features or functions.

[0053] In some cases, the fluid coupling assembly 100 is provided to the end user under sterile conditions, or is made compatible with sterilization. As used herein, the term "sterilization" refers to the process of making a surface or volume free from microorganisms to a certain extent. In an exemplary embodiment, one or more sterilization techniques can be used to achieve the sterility of various components, and the sterilization techniques include gamma radiation, electron beam, ethylene oxide (EtO) and / or autoclave technology. As used herein, the term "sterile" refers to any process that maintains a sterile surface or volume. In some cases, the fluid coupling device 100 is provided to the end user as a component of the system.

[0054] Usually, if Figure 1-3 As shown, the fluid coupling assembly 100 is provided to the end user in a coupling arrangement together with the coupled mating coupling halves 200 and 300. The end user will use the fluid coupling assembly 100 in the coupling arrangement and then disconnect the first coupling 200 and the second coupling 300 from each other after such use. When disconnection is performed, the fluid flow path 103 in each of the coupling halves 200 and 300 is aseptically sealed in a closed state. In addition, when disconnection of the coupling halves 200 and 300 is performed, no fluid (or only a minimal amount of fluid) overflows to an area outside the fluid coupling assembly 100 during the disconnection process.

[0055] The first connector 200 includes a first terminal 222. The second connector 300 includes a second terminal 322. Although the first terminal 222 and the second terminal 322 are depicted as barbed connectors, it should be understood that the connector halves 200 and 300 can have any type of connector, such as but not limited to threaded connectors (e.g., straight threads or pipe threads), sanitary fittings, compression fittings, aseptic connectors, quick connectors, quick disconnects, hydraulic connectors, Luer fittings, solder connectors, welding connectors, etc., and combinations thereof. Such connectors can be straight (as shown) or in another arrangement, such as but not limited to a 90° elbow arrangement, a 45° elbow, a straight fitting, a T-shaped fitting, a Y-shaped fitting, etc. In some embodiments, the connector halves 200 and / or 300 can be configured to be fluidly coupled to a fluid conduit, such as but not limited to a tube, a pipe, a manifold, etc., but not limited thereto.

[0056] The material from which one or more components of the fluid coupling assembly 100 are made includes thermoplastics or thermosetting plastics. In certain embodiments, the material from which the components of the fluid coupling assembly 100 are made is a thermoplastic, such as, but not limited to, acetal, ABS, polycarbonate, polysulfone, polyetheretherketone, polysulfide, polyester, polyvinylidene fluoride (PVDF), polyethylene, perfluoropolymers (PFA, PTFE, PCTFE, etc.), polyphenylsulfone (PPSU, e.g. ), polyetherimide (PEI, e.g. ), polypropylene, polyphenylene, polyaryletherketone, perfluoropolymer (PFA, PTFE, PCTFE, etc.), etc. and combinations thereof. In some embodiments, the thermoplastic may include one or more fillers, such as but not limited to glass fiber, glass beads, carbon fiber, talc, etc.

[0057] In some embodiments, the material from which one or more components of fluid coupling assembly 100 are made includes metal, such as but not limited to stainless steel, brass, aluminum, plated steel, zinc, etc. In certain embodiments, one or both coupling halves 200 and 300 are metal-free.

[0058] In some embodiments, one or both of the coupling halves 200 and / or 300 include one or more plastics (e.g., PEEK, PPS, etc.) or metal spring members (e.g., spring steel, stainless steel such as 316L, piano / music wire, beryllium copper, titanium, wait).

[0059] In certain embodiments, the fluid coupling assembly 100 includes one or more gaskets or seals made of materials such as, but not limited to, silicone, fluoroelastomer (FKM), ethylene propylene diene monomer (EPDM), perfluoroelastomer (e.g., FFKM, The gasket or seal may be made of materials such as TPE, buna, buna-N, thermoplastic vulcanizate (TPV), etc. In some embodiments, the gasket or seal may have a cross-sectional shape of hourglass, oval, round, D-shaped, X-shaped, square, rectangular, U-shaped, L-shaped, V-shaped, polygonal, multi-lobal, or any other suitable shape, but is not limited thereto.

[0060] Figures 4 to 11The process of disconnecting the coupling halves 200 and 300 is shown. The components of the fluid coupling assembly 100 are designed so that the steps described below for disconnecting the coupling halves 200 and 300 can only be performed in the order described. That is, the fluid coupling assembly 100 includes a mechanical structure that prevents any steps from being performed out of sequence. In addition, when a step is fully performed, the step cannot be reversed. The fluid coupling assembly 100 includes a mechanical structure that latches the components in various positions associated with the completion of each sequential step of the disconnection process.

[0061] The sequence of steps for disconnecting coupling halves 200 and 300 will ensure that the fluid flow paths of coupling halves 200 and 300 (e.g., Figure 3 The fluid flow path 103 shown in FIG. 1 is closed in a fluid-tight manner before the coupling halves 200 and 300 are separated. Therefore, the fluid flow path of the coupling halves 200 and 300 is prevented from being contaminated. In addition, when the coupling halves 200 and 300 are separated, no fluid (or only very little fluid) is spilled or released.

[0062] Specific reference Figure 4 and Figure 5 , coupling half 200 includes a shell 250 surrounding a portion of coupling half 200. Shell 250 is manually rotatable relative to fluid coupling assembly 100. Manual rotation of shell 250 about longitudinal axis 102 of fluid coupling assembly 100 drives the closing of valves in each of coupling halves 200 and 300 and the physical separation of coupling halves 200 and 300, as described further below.

[0063] Also refer to Fig.12 and Fig.13 , one half of the shell 250 is shown separately here so that the features of the shell 250 can be more clearly visualized. The shell 250 includes the two half shells shown. That is, in the embodiment of the coupling half 200 shown, two identical half shells are joined together to form a cylindrical shell 250 that is rotatably connected to the coupling half 200. In some embodiments, the components that constitute the shell 250 can be different from each other. In the depicted embodiment, the two identical half shells are mechanically snapped together to form the cylindrical shell 250. In some embodiments, other connection techniques can be used, or the shell 250 can be created as a single integral component.

[0064] like Figure 4 , Figure 5 , Fig.12 and Fig.13As shown, the housing includes two latch tabs 252. The latch tabs 252 are releasably engaged with the coupling half 300. When the latch tabs 252 are engaged with the coupling half 300, the housing 250 cannot rotate relative to the fluid coupling assembly 100. Figures 1 to 3 The latch tab 252 is shown engaged with the coupling half 300 .

[0065] The first step in the sequence of steps to disconnect the coupling halves 200 and 300 is to disengage the latch tab 252 from the coupling half 300. Figure 4 and Figure 5 . In the depicted embodiment, the latch tab 252 is manually pivoted radially outward to disengage the latch tab 252 from the coupling half 300. In some embodiments, other types of disengagement mechanisms and techniques (besides pivoting the latch tab 252) may be used. For example, in some embodiments, the disengagement mechanism may be (or may include) a removable locking tab, a spring loaded clip, a clamp and release mechanism, a push and release mechanism, a tear ring component that locks the shell 250 to the insert housing 310 and the shuttle 240 during operation, a deflectable feature (such as a cantilever that the user will deflect to remove the interference and allow rotation). Another disengagement mechanism would be a translatable feature - such as a sliding latch on each side that moves axially, or a single ring that engages two slots and is pulled back / moved axially to allow rotation.

[0066] Shell 250 may be considered a tamper-resistant sleeve or anti-cone guard because other steps for disconnecting coupling halves 200 and 300 cannot be performed when latch tab 252 is engaged with coupling half 300. Therefore, unlocking of latch tab 252 from coupling half 300 must be the first step in the sequence of steps required to disconnect coupling halves 200 and 300.

[0067] The first step in the sequence of steps to disconnect coupling halves 200 and 300 is accomplished by disengagement of latch tab 252 .

[0068] refer to Figure 6 and Figure 7 With the latch tab 252 disengaged from the coupling half 300, the next step in the sequence of steps to disconnect the coupling halves 200 and 300 is to manually rotate the housing 250, such as Figure 6 (In other embodiments, the housing 250 may be rotated in the opposite direction.) The rotation of the housing 250 closes the valve in each of the coupling halves 200 and 300, such that the previously open fluid flow path 103 is blocked.

[0069] Hereinafter, the coupling half 200 may also be referred to as the body 200 or as the first coupling 200, and the coupling half 300 may also be referred to as the insert 300 or as the second coupling 300. The use of the nomenclature of the body 200 and the insert 300 will also be used to identify some of the components of the body 200 and the insert 300.

[0070] As shown, for example, in Figure 5 and 7 In the embodiment, the main body 200 includes a main body valve 230, and the insert 300 includes an insert valve 330. The main body valve 230 is Figures 14 to 16 , and the insert valve 330 is shown separately in Figures 17 to 19 The front face 232 of the main body valve 230 and the front face 332 of the insert valve 330 have complementary structures by which the main body valve 230 and the insert valve 330 can be releasably coupled to each other (e.g., as Figure 3 , Figure 5 and Figure 7 ), until the body 200 is separated from the insert 300. In addition, the body valve gasket 260 ( Figure 20-23 ) provides a face seal between the outer annular sealing surfaces of the front faces 232 and 332 of the main body valve 230 and the insert valve 330.

[0071] The body valve gasket 260 has an annular portion 262 that is seated in the sealing groove 234 defined by the body valve 230. The body valve gasket 260 also has a face seal portion 264 that provides a seal between the front face 232 of the body valve 230 and the front face 332 of the insert valve 330. The seal provided by the face seal portion 264 positioned between the front face 232 of the body valve 230 and the front face 332 of the insert valve 330 advantageously contributes to the no-spill performance feature of the fluid coupling assembly 100 by preventing fluid from entering between the body valve 230 and the insert valve 330.

[0072] When the fluid coupling assembly 100 is in the Figure 1-3 In the operative configuration shown, for example, both the body valve 230 and the insert valve 330 are in their open configurations (such that an open fluid flow path 103 exists). However, after a sufficient amount of rotation of the housing 250 (e.g., Figure 6 ), both the main valve 230 and the insert valve 330 are transformed into their closed configurations (such that the open fluid flow path 103 no longer exists). For example, the closed configuration Figure 7 As rotation of the housing 250 drives the insert 300 (except for the insert valve 330) and the shuttle 240 to translate further longitudinally into the body 200, a closed configuration is created.

[0073] The shuttle 240 Figure 24 to Figure 26 The shuttle 240 is an open cylinder. Figure 5 and Figure 7 As can be seen in FIG. 1 , when the fluid coupling assembly 100 is in the operable configuration, the body valve 230 and the insert valve 330 are located within the open interior space defined by the shuttle 240 .

[0074] The shuttle 240 further defines a groove 242 that includes a helical extension and a circumferential extension. The groove 242 slidably receives a corresponding protrusion 254 ( Fig.12 ). Thus, rotation of housing 250 causes protrusion 254 to move within groove 242 of shuttle 240 (because shuttle 240 is restrained from rotating while being free to translate longitudinally). As protrusion 254 moves within the helical extension of groove 240 due to rotation of housing 250, shuttle 240 is thereby forced to translate longitudinally. Sufficient continuation of this longitudinal translation of shuttle 240 removes fluid coupling assembly 100 from Figure 1-3 The operable / open configuration shown in is reconfigured as Figure 6 and 7 The closed configuration shown in .

[0075] When the shuttle 240 is longitudinally translated due to manual rotation of the shell 250, the shuttle 240 longitudinally pulls the insert housing 310 (at Figure 27-29 ) and the insert terminal 320 (shown separately in Figure 30-32 Insert terminal 320 includes a central post 324 that is slidably coupled to insert valve 330. Thus, when insert terminal 320 translates due to rotation of housing 250 and translation of shuttle 240, insert terminal 320 slides relative to insert valve 330. Figure 5 and Figure 7 This is obvious in comparison.

[0076] Alternatively, rather than the depicted arrangement in which the insert terminal 320 includes a central post 324 on which the insert valve 330 slides, in some embodiments, the insert terminal 320 includes longitudinally extending ribs and the insert valve 330 includes corresponding grooves. This arrangement is similar to a double key and keyway arrangement. Other types of cooperating mechanical features between the insert terminal 320 and the insert valve 330 are also contemplated by which the insert valve 330 can be longitudinally translated relative to the insert terminal 320. For example, in some embodiments, the insert terminal 320 includes a centrally located annular ring in which the insert valve 330 slides.

[0077] The second step in the sequence of steps to disconnect coupling halves 200 and 300 is accomplished by closing / sealing of body valve 230 relative to shuttle 240 and insert valve 330 relative to insert terminal 320 .

[0078] When the fluid coupling assembly 100 arrives Figure 6 and Figure 7 After the closed configuration shown in FIG. 1 , continued / additional rotation of the housing 250 then reconfigures the fluid coupling assembly 100 into Figure 8 and Fig. 9 The arrangement shown in Figure 8 and Fig. 9 In the illustrated configuration, the front faces 232 and 332 of the body valve 230 and the insert valve 330 have become unengaged and physically separated from one another.

[0079] Separation of the main valve 230 and the insert valve 330 (eg Fig. 9 As can be seen in the following example, Figure 7 and 27 -29, the insert housing 310 includes two flexible cantilever arms 312, which are initially aligned with the recess 244 ( Figure 24-26 However, when the insert housing 310 translates due to the rotation of the shell 250, the cantilever 312 eventually contacts the compound ramp 256 located on the inner diameter surface of the shell 250 (see Fig.12 The compound ramp 256 exerts a radially outward force on the cantilever 312 to resiliently deflect the cantilever 312 radially outward into a recessed area 258 defined by the inner diameter surface of the shell 250. The radially outward deflection of the cantilever 312 causes the insert housing 310 to separate from the shuttle 240. Figure 7 and Fig. 9 This is obvious in comparison.

[0080] In another configuration, the cantilever 312 may deflect due to contact with a ramp on the body housing 210 rather than the body shell 250. In this case, the longitudinal travel of the shuttle 240 causes deflection of the shell 250 rather than rotational travel.

[0081] During this third step in the sequence of steps for disconnecting the coupling halves 200 and 300, as the compound ramp 256 applies force on the cantilever 312, the sliding O-ring seal between the insert terminal 320 and the shuttle 240 moves longitudinally within the shuttle 240 from a high compression (sealing) area to a low compression (release) area.

[0082] Further rotation of the shell 250 (when the cantilevered arms 312 of the insert housing 310 disengage from the shuttle 240) then causes the compound ramp 256 to exert a longitudinal force on the cantilevered arms 312 to force the insert housing 310 to move longitudinally away from the body 200. Fig.10 and Fig.11 , further rotation of the shell 250 (while the cantilever arm 312 of the insert housing 310 is disengaged from the shuttle 240) then causes the compound ramp 256 to apply a longitudinal force to the cantilever arm 312 to force the insert housing 310 to move longitudinally away from the body 200.

[0083] The third step in the sequence of steps to disconnect coupling halves 200 and 300 is accomplished by disengagement of insert housing 310 from shuttle 240 and longitudinal separation of front faces 232 and 332 of body valve 230 and insert valve 330 .

[0084] The fourth and final step in the sequence of steps for disconnecting the coupling halves 200 and 300 is accomplished by manually separating the body 200 longitudinally from the insert 300, as shown in FIG. Fig.10 and Fig.11 By Fig. 9 and Fig.11 This is obvious in comparison.

[0085] The main body 200 further includes a main body housing 210 ( Figure 33-35 ) and the main terminal 220 ( Figure 36-38 ). The main body valve 230 is fixedly coupled to the central column 224 of the main body terminal 220. The front of the main body housing 210 is configured with an annular sawtooth pattern 212. In another configuration, the ratchet and pawl mechanism can be reversed. That is, the sawtooth pattern 212 can be placed on the shell 250, wherein the flexible pawl extends from the main body housing 210.

[0086] The sawtooth pattern 212 and the pawl 259 of the housing 250 ( Fig.12 ) are engaged to include a one-way rotation mechanism. That is, in a general sense, due to the ratchet and pawl mechanism provided by the sawtooth pattern 212 of the main body shell 210 and the pawl 259 of the shell 250, the shell 250 can only rotate in one direction relative to the main body 200 and the insert 300. However, more specifically, it should be understood that the ratchet and pawl mechanism provided by the sawtooth pattern 212 and the pawl 259 allows a small amount of rotation of the shell 250 in the opposite direction. The amount of rotation in the reverse direction is limited by the size of the teeth of the sawtooth pattern 212. That is, the shell 250 can rotate in the reverse direction up to, but not more than, the width of a single tooth of the sawtooth pattern 212.

[0087] Furthermore, sawtooth pattern 212 is selectively designed and configured with a specific number of teeth and specific sizes of teeth such that each rotation increment of housing 250 (determined by a single tooth of sawtooth pattern 212) corresponds to a desired translation distance of shuttle 240 and / or a maximum allowable reverse rotation amount of housing 250. For example, in some embodiments, the maximum allowable reverse rotation amount of housing 250 is determined by seal 224 ( Figure 5 ), the seal 224 is radially compressed in position between the shuttle 240 and the body terminal 220. By limiting the maximum allowable amount of reverse rotation of the housing 250, reverse translation of the seal 224 of the shuttle 240 relative to the body terminal 220 can be limited to no more than the width of the sealing surface of the seal 224, thereby preventing contaminants from entering the fluid-wetted interior area of ​​the fluid coupling assembly 100.

[0088] The body 200 includes a body housing 210, a body terminal 220, a body valve 230, a shuttle 240, a shell 250, and a body valve gasket 260. The shell 250 is rotatably coupled to the body housing 210. The body housing 210 is fixedly coupled to the body terminal 220. The body valve 230 is fixedly coupled to the body terminal 220. The shuttle 240 is disposed around the body valve 230 and is movable (can be longitudinally translated) relative to the body valve 230 between an open configuration and a closed configuration. The closed configuration is obtained by rotating the shell 250, which drives the shuttle 240 longitudinally from the open configuration to the closed configuration. The shuttle 240 does not rotate when translated.

[0089] Insert 300 includes an insert housing 310, an insert terminal 320, and an insert valve 330. Insert housing 310 is fixedly coupled to insert terminal 320. Insert valve 330 is movably coupled to insert terminal 320 such that insert valve 330 is longitudinally translatable relative to insert terminal 320 along a longitudinal axis between an open configuration and a closed configuration.

[0090] Fig.39 Another fluid coupling assembly 100' is shown. The fluid coupling assembly 100' includes a first coupling 200' and a second coupling 300'. The fluid coupling assembly 100' operates in the same manner as the fluid coupling assembly 100. The structure of the fluid coupling assembly 100' is similar to the fluid coupling assembly 100, except that the first coupling 200' and the second coupling 300' have several different components compared to the first coupling 200 and the second coupling 300, as further described below.

[0091] In the depicted embodiment of the fluid coupling assembly 100', the first coupling 200' includes a shell 250' and a retainer clip 252'. These components are the shell 250 of the first coupling 200 (e.g., Fig.12and Fig.13 ) and a latch tab 252 (e.g., Fig.12 and Fig.13 ). While in the embodiment of the first coupling 200 the latch tab 252 is integrally formed with the shell 250, in the embodiment of the first coupling 200' the shell 250' and the retainer clip 252' are separate components. In particular, the first step in the sequence of steps for disconnecting the coupling halves 200' and 300' is to remove the retainer clip 252' from its engagement with the shell 250'.

[0092] Fig.40 and 41 Shell 250' is shown separately. Like shell 250 described above, shell 250' includes protrusions 254, compound ramps 256, and detents 259. In addition, shell 250' includes or defines a cross-shaped opening 251. Cross-shaped opening 251 allows corresponding protrusions of retainer clip 252' to pass through shell 250' and engage with insert housing 310' of second coupling 300'.

[0093] Fig.42 and 43 The retainer clip 252' is shown separately. The retainer clip 252' is a C-shaped flexible member that can be manually deflected to remove it from its engagement with the shell 250' of the first coupling 200' and the insert housing 310' of the second coupling 300'.

[0094] In the depicted embodiment, the retainer clip 252' includes two protrusions 253, each protrusion 253 having an adjacent latch 255 (two latches 255 total). The latches 255 releasably retain the retainer clip 252' on the shell 250' (or on two of the shells 250'). The two latches 255 releasably engage with the shell 250' at the edge portion defining the cross-shaped opening 251. The protrusion 253 passes through the cross-shaped opening 251 of the shell 250'. After passing through the cross-shaped opening 251, the protrusion 253 engages with the opening defined by the insert housing 310', as further described below.

[0095] Fig.44 and 45Another embodiment of a retainer clip 252" is shown separately. Retainer clip 252" may be used in place of retainer clip 252'. Retainer clip 252" includes two protrusions 253, each protrusion 253 having two adjacent latches 255 (four latches 255 for a total of four latches 255). The latches 255 releasably retain the retainer clip 252' on the shell 250' (or on two of the shells 250'). The four latches 255 releasably engage with the shell 250' at edge portions defining the cross-shaped opening 251. The protrusion 253 passes through the cross-shaped opening 251 of the shell 250'. After passing through the cross-shaped opening 251, the protrusion 253 engages with the opening defined by the insert housing 310', as further described below.

[0096] Fig.46 and 47 Another embodiment of a retainer clip 252'" is shown separately. Two of the removable retainer clips 252'" can replace a single retainer clip 252' or a single retainer clip 252" for a fluid coupling assembly 100'. Each retainer clip 252'" includes a protrusion 253 and two adjacent latches 255. The latches 255 releasably retain the retainer clip 252'" on the shell 250'. The two latches 255 releasably engage with the shell 250' at the edge portion defining the cross-shaped opening 251. The protrusion 253 passes through the cross-shaped opening 251 of the shell 250'. After passing through the cross-shaped opening 251, the protrusion 253 engages with the opening defined by the insert housing 310', as further described below.

[0097] Fig.48 and 49The insert housing 310' of the second coupling 300' is shown. The insert housing 310' also includes a second terminal 322. In other words, compared to the second coupling 300 (which includes the insert housing 310 and the insert terminal 320 as separate components), the insert housing 310' is a single integral component that acts as the insert housing and terminal of the second coupling 300'. The insert housing 310' defines two openings 311. The opening 311 releasably receives the protrusion 253 of the retainer clip 252', the retainer clip 252" or the retainer clip 252"'. Although this specification contains many specific implementation details, these should not be interpreted as limitations on any invention or the scope of protection that may be claimed, but rather as descriptions of features that may be specific to a specific embodiment of a particular invention. Certain features described in the context of separate embodiments in this specification may also be implemented in combination in a single embodiment. Conversely, the various features described in the context of a single embodiment may also be implemented in multiple embodiments individually or in any suitable sub-combination. Furthermore, although features may be described herein as working in certain combinations and even initially claimed as such, one or more features from the claimed combination may in some cases be deleted from the combination, and the claimed combination may be directed to sub-combinations or variations of sub-combinations.

[0098] Similarly, although operations are depicted in a particular order in the drawings, this should not be understood as requiring that the operations be performed in the particular order shown or in sequential order, or that all of the operations shown be performed, to achieve the desired results. In addition, the separation of various system modules and components in the embodiments described herein should not be understood as requiring such separation in all embodiments.

Claims

1. A single-use sterile fluid coupling assembly, the single-use sterile fluid coupling assembly defining a longitudinal axis and an open fluid flow path through the fluid coupling assembly along the longitudinal axis, the fluid coupling assembly comprising: A first connecting member, the first connecting member comprising: a first shell; a first terminal member fixedly coupled to the first housing and including a first terminal; a shell rotatably coupled to the first housing; a first valve fixedly coupled to the first terminal member; and a shuttle disposed about the first valve, the shuttle coupled to the housing such that the shuttle is translatable along the longitudinal axis in response to rotation of the housing; and A second coupling member releasably connected to the first coupling member and comprising: a second shell; a second terminal member fixedly coupled to the second housing and including a second terminal; and a second valve movably coupled to the second terminal, the second valve being translatable relative to the second terminal along the longitudinal axis, Wherein the first valve is releasably latched to the second valve.

2. The fluid coupling assembly of claim 1, wherein the fluid coupling assembly is metal-free.

3. The fluid coupling assembly of claim 1 or 2, further comprising a valve gasket compressed between the outer annular surface portion of the first valve and the outer annular surface portion of the second valve.

4. The fluid coupling assembly of claim 1 or 2, wherein the housing includes one or more protrusions movably disposed in one or more slots defined by the shuttle.

5. The fluid coupling assembly of claim 4, wherein the one or more slots each comprise: (i) a helically extending portion and (ii) a circumferentially extending portion.

6. The fluid coupling assembly of any one of claims 1 to 5, wherein the shuttle is releasably coupled to the second housing.

7. A fluid coupling assembly according to any one of claims 1 to 5, wherein the first coupling is separable from the second coupling by rotating the housing and then longitudinally separating the first coupling and the second coupling from each other.

8. The fluid coupling assembly of claim 7, wherein the first coupling and the second coupling cannot be separated from each other until: (i) the first valve is in a closed configuration relative to the shuttle, and (ii) the second valve is in a closed configuration relative to the second terminal member.

9. The fluid coupling assembly of claim 8, wherein rotating the housing moves the first and second valves to the closed configuration.

10. The fluid coupling assembly of claim 7, wherein rotating the housing unlocks the first valve from the second valve.

11. The fluid coupling assembly of claim 7, wherein rotating the housing decouples the shuttle from the second housing.

12. A single-use sterile fluid coupling assembly, the single-use sterile fluid coupling assembly defining a longitudinal axis and an open fluid flow path through the fluid coupling assembly along the longitudinal axis, the fluid coupling assembly comprising: A first connecting member, the first connecting member comprising: a first housing; and a first valve; and A second coupling member releasably connected to the first coupling member and comprising: a second housing; and a second valve that is translatable along said longitudinal axis, wherein the first valve is releasably latched to the second valve, and Wherein once the first coupling and the second coupling have been disconnected from one another, the first coupling and the second coupling cannot be reconnected to define an open fluid flow path.

13. The fluid coupling assembly of claim 12, wherein the first coupling further comprises a shell rotatably coupled to the first housing.

14. The fluid coupling assembly of claim 13, wherein the housing includes one or more projections movably disposed in one or more slots defined by the shuttle.

15. The fluid coupling assembly of claim 14, wherein the first coupling further comprises a shuttle disposed about the first valve, the shuttle coupled to the housing such that the shuttle is translatable along the longitudinal axis in response to rotation of the housing.

16. The fluid coupling assembly of any one of claims 12 to 15, further comprising a valve gasket compressed between the outer annular surface portion of the first valve and the outer annular surface portion of the second valve.

17. The fluid coupling assembly of any one of claims 12 to 15, wherein the fluid coupling assembly is metal free.

18. The fluid coupling assembly of any one of claims 12 to 15, wherein the first coupling and the second coupling cannot be disconnected from each other until both the first valve and the second valve are in the closed configuration.

19. The fluid coupling assembly of any one of claims 12 to 15, further comprising a retainer clip releasably coupled to the first coupling and the second coupling.

20. The fluid coupling assembly of claim 19, wherein the retainer clip is a flexible C-shaped member comprising: (i) two projections that are releasably engaged within an opening defined by the first link and the second link, and (ii) at least two latches that are releasably coupled to the first link.

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