Patent Description:
This document relates to fluid coupling devices for fluid systems and methods. For example, some embodiments described in this document relate to single-use, aseptic disconnection fluid coupling devices.

Fluid systems commonly include components such as tubing, pumps, reservoirs, fittings, couplings, heat exchangers, sensors, filters, valves, seals, and the like. Such components can be connected together in a network to define one or more fluid flow paths. Some fluid systems are open systems, meaning that the fluid flows through the network once and then exits the network. Other fluid systems are closed systems, meaning that the fluid recirculates within the network of components. Fluids may be moved through fluid systems using fluid pressure differentials. For example, in some cases, a pump or a vacuum source is used to create a pressure differential that causes the fluid to flow within the fluid system. In another example, gravity is used to cause the fluid to flow within the fluid system. In other examples, a combination of such techniques is used to cause the fluid to flow within the fluid system.

In the context of some fluid systems, such as some bioprocessing fluid systems, it may be desirable to have a coupler that can aseptically disconnect a fluid flow path. In one such example implementation, it is desirable to aseptically disconnect one or more media bags from a bioreactor system. In that scenario, an aseptic coupling can be used to disconnect the media bag(s) from the bioreactor system while substantially preventing biological contamination of the media bags and of the bioreactor via the disconnected ends of the coupling during and after the disconnection process. Such an aseptic coupling will also serve to limit the exposure of the fluid to the surrounding environment.

<CIT> describes a coupling which includes male and female portions thereof. The male portion usually has pressure applied to it due to heat build up from the environment. The male portion can be and usually is attached to a farm implement. Left in a field in the sun, pressure builds in the male portion while it is disconnected from the female portion. The female portion of the coupling enables the connection of the male portion without spilling any fluid from either the male or the female portions.

<CIT> describes a snap-closure coupling for flowing medium ducts has two halves one of which can be plugged into the other. The arrangement is such that the flow paths through both the plug half (which is connected to a medium source) and through the socket or sleeve half (which is connected to a reservoir, such as the applied brakes of a trailer) will be blocked when the plug half is pressureless and the sleeve half is pressurized. However, when the plug half is inserted into the sleeve half, the flow paths through both halves are automatically opened.

<CIT> describes a female coupling member for a low-spill, quick-disconnect coupling where a male coupling member has a valve with a conical head projecting axially forward of a forward end of a body of the male coupling member.

<CIT> describes a high flow low spill quick coupling valve assembly that is used to connect to pressurized, large diameter fluid lines.

This document describes a number of fluid coupling devices for fluid systems and methods. In some embodiments, the fluid coupling devices can be implemented as single-use, aseptic disconnection fluid coupling devices that are configured to reduce the likelihood of fluid spillage when being disconnected. In the context of this disclosure, the term "fluid" includes both gases and liquids.

In particular embodiments, the fluid coupling devices described herein are single-use devices because, after the two portions of the coupling (also referred to herein as "coupling halves" and/or "connectors") are disconnected from each other, the fluid paths of both portions are irreversibly blocked. For example, such single-use coupling devices are equipped with one or more mechanical components that operates such that, even if the coupling halves are reconnected to each other after being disconnected, the flow paths will remain blocked. Hence, in these particular embodiments, the fluid coupling devices provided herein are structurally configured to be single-use disconnection devices so 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).

Additionally, in such single-use embodiments or in other embodiments, the fluid coupling devices can be configured as "aseptic" coupling devices in that, after the two portions of the coupling device are disconnected from each other, the fluid paths of both portions are mechanically blocked so as to inhibit biological contamination migrating into the flow paths. Such an "aseptic" coupling will also serve to limit the exposure of the fluid to the surrounding environment.

Further, in such single-use embodiments, or other embodiments, the fluid coupling devices can be configured as no-spill coupling devices because, as the two portions of the coupling device are being disconnected from each other, one or more mechanical components will reduce the likelihood of fluid discharge out of the fluid system (for example, by blocking as such discharge paths).

In one implementation, a fluid coupling device includes a male connector component. The male connector component defines a first male connector internal space and a second male connector internal space. The fluid coupling device also includes a male coupling shuttle valve member partially disposed within the first male connector internal space and partially disposed within the second male connector internal space. The fluid coupling device also includes a locking sleeve coupled to the male connector component. The fluid coupling device also includes a female connector component that is releasably matable with the male connector component. The female connector component defines a female connector internal space. The fluid coupling device also includes a female coupling shuttle valve member at least partially disposed within the female connector internal space. The female coupling shuttle valve member is also partially disposed within the second male connector internal space when the female connector component releasably mates with the male connector component.

Such a fluid coupling device may also include one or more of the following optional features. In some embodiments, a cross-sectional shape of each of the male coupling shuttle valve member and the female coupling shuttle valve member is non-circular. The locking sleeve may be coupled with the male coupling shuttle valve member. In various embodiments, the male coupling shuttle valve member and the female coupling shuttle valve member are each the same physical shape. The locking sleeve may be slidably coupled to the male connector component. In some embodiments, the locking sleeve comprises one or more unlocking members that must be actuated prior to sliding the locking sleeve in relation to the male connector component. The male coupling shuttle valve member and the female coupling shuttle valve member may each include one or more apertures. In some embodiments, all elements of the fluid coupling device are non-metallic. In particular embodiment, when the male connector component is fully disconnected from the female connector component, the male coupling shuttle valve member blocks fluid flow through the first male connector internal space and blocks fluid flow through the second male connector internal space, and the female coupling shuttle valve member blocks fluid flow through the female connector internal space. Optionally, the male connector component and the female connector component are releasably coupled via a bayonet connection.

In another implementation, a fluid coupling device includes a male connector component and a male coupling shuttle valve member disposed within the male connector component. The fluid coupling device also includes a locking sleeve coupled to the male connector component. The locking sleeve is coupled to the male coupling shuttle valve member. The fluid coupling device also includes a female connector component releasably matable to the male connector component, and a female coupling shuttle valve member partially disposed within the male connector component and partially disposed within the female connector component when the female connector component releasably mates with the male connector component.

Such a fluid coupling device may optionally include one or more of the following features. The locking sleeve may be slidably coupled to the male connector component. In some embodiments, sliding the locking sleeve longitudinally along the male connector component also longitudinally slides the male coupling shuttle valve member and the female coupling shuttle valve member within the fluid coupling device. In particular embodiments, the sliding the locking sleeve may cause a blockage of fluid flow through the fluid coupling device. The blockage of the fluid flow through the fluid coupling device may be irreversible in some implementations. Optionally, no components other than seals are under substantial mechanical stress while the female connector component releasably mates with the male connector component. In some embodiments, the fluid coupling device is metallic-free. The fluid coupling device may define a fluid flow path through the fluid coupling device. The fluid flow path may extend through: a) a first male connector internal space defined by the male connector component, b) an internal male coupling shuttle valve member space defined by the male coupling shuttle valve member, c) a second male connector internal space defined by the male connector component, d) an internal female coupling shuttle valve member space defined by the female coupling shuttle valve member, and e) a female connector internal space defined by the female connector component. In some embodiments, the sliding the locking sleeve along the male connector component toward the female connector component causes a blockage of the fluid flow path. In particular embodiments, the blockage of the fluid flow path is irreversible.

In another implementation, a fluid system is provided that includes a first fluid system equipment or container, a second fluid system equipment or container, and a single-use, aseptic disconnection fluid coupling device. The single-use, aseptic disconnection fluid coupling device is configured to provide a fluid path between the first fluid system equipment or container and the second fluid system equipment or container. The single-use, aseptic disconnection fluid coupling device includes a male connector component releasably lockable with a corresponding female connector component, a male coupling shuttle valve member disposed within the male connector component, and a locking sleeve coupled to the male connector component. The locking sleeve is coupled to the male coupling shuttle valve member. The single-use, aseptic disconnection fluid coupling device also includes a female coupling shuttle valve member at least partially disposed within the female connector component and partially disposed within the male connector component when the male connector component releasably locks with the female connector component.

In another implementation, a method of using a single-use, aseptic disconnection fluid coupling device includes providing a fluid path through a single-use, aseptic disconnection fluid coupling device and between a first fluid system equipment or container and a second fluid system equipment or container. The method of using a single-use, aseptic disconnection fluid coupling device also includes disconnecting a male connector component of the single-use, aseptic disconnection fluid coupling device from a corresponding female connector component so that the fluid path through each of the male connector component and female connector component are irreversibly and mechanically blocked by a corresponding mechanical element.

Particular embodiments of the subject matter described in this document can be implemented to realize one or more of the following advantages. First, in some embodiments the fluid coupling devices provided herein are configured to allow fluid flow therethrough with a minimized amount of pressure drop. For example, some embodiments of the fluid coupling device can be configured for connection to ½-inch inside diameter tubing while also having a pressure drop that is similar to the pressure drop of an equivalent length of ½-inch inside diameter tubing.

Second, in some embodiments, the fluid coupling devices may advantageously provide a user with audible and/or tactile feedback in reference to the motions performed for physically disconnecting the two portions of the fluid coupling devices from each other. Such audible and/or tactile feedback can provide the user with an efficient and conclusive indication or confirmation of the proper function and desired configuration of the fluid coupling device.

Third, some embodiments of the fluid coupling devices provided herein are a metallic-free construction (also referred to as a nonmetallic fluid coupling device). As such, such embodiments of the nonmetallic fluid coupling devices can be advantageously sterilized using a gamma sterilization technique. Also, in some circumstances, the nonmetallic fluid coupling devices exhibit enhanced fatigue-resistance characteristics, minimal installed stress, and enhanced corrosion resistance in comparison to some fluid couplings that include traditional metallic parts such as metal springs.

Fourth, some embodiments of the fluid coupling devices provide an improved aseptic disconnection capability that may optionally reduce or eliminate the need for sterile rooms or sterile benchtop environments in some cases. As such, these embodiments of the aseptic fluid coupling devices described herein may facilitate efficient and cost-effective operations or uses that would otherwise be high-cost or even cost prohibitive in some traditional settings that required the disconnection of particular fluid couplings in a sterile room or within a sterile flow-hood to prevent biological contamination.

Fifth, some embodiments of the fluid coupling devices provided herein are advantageously designed with a robust locking system. That is, when the two halves of the coupling are operably connected with each other, they are also mechanically locked together. In some embodiments, to release the lock, two buttons on the coupling must be simultaneously depressed. This redundant requirement (e.g., simultaneous actuation of two buttons or other actuators) for unlocking the coupling halves may reduce the likelihood of unintentional disconnections.

Sixth, in some optional embodiments, when the two halves of the fluid coupling devices are mated together, most components of the coupling device are not under substantial mechanical stress that would induce warping. This configuration is advantageous because, for example, the heat associated with some sterilization processes may cause stressed components to warp or to induce warping of other components. Since most of the components of the coupling device are not under substantial mechanical stress during sterilization, the propensity for the coupling device to warp is reduced or substantially eliminated.

Seventh, in some embodiments, the coupling halves of the fluid coupling devices provided herein are coupled via a bayonet connection that is configured to assist with disconnection of the coupling halves. As explained further below, the bayonet connection mechanism includes a non-orthogonal slot that induces a slight longitudinal separation of the coupling halves as the coupling halves are rotated in relation to each other during disconnection. The resulting slight separation is advantageous for breaking a seal (or vacuum) that may exist between the coupling halves, and that may otherwise be difficult or inconvenient for a user to break.

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 this disclosure pertains. In addition, the materials, methods, and examples of the embodiments described herein are illustrative only and not intended to be limiting.

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description herein.

Like reference numbers represent corresponding parts throughout.

Referring to <FIG>, some example embodiments of a fluid system <NUM> include one or more example fluid coupling devices <NUM> configured to, for example, releasably connect a first fluid system equipment or container <NUM> to a second fluid system equipment or container <NUM>. In some implementations, the fluid system <NUM> may include at least one fluid coupling device <NUM> that is a single-use, aseptic disconnection fluid coupling device, in which first and second mating components <NUM> and <NUM> are configured to disconnect from one another in a manner that provides an aseptic disconnection and that mechanically prevents reuse of the fluid path through the mating components <NUM> and <NUM>. (The first and second mating portions <NUM> and <NUM> are sometimes referred to herein as "coupling halves" or a "coupling-half" even though the components <NUM> and <NUM> are not necessarily equal halves in terms of size, shape, or weight. ) In one non-limiting example, the fluid coupling <NUM> can provide a single-use, aseptic disconnection capability for a fluid path between the fluid system equipment <NUM> in the form of a bioreactor system (connected directly to the coupling device <NUM> or connected via a fluid tube <NUM>) and the fluid system container <NUM> in the form of a media bag (connected directly to the coupling device <NUM> or connected via a fluid tube <NUM>).

Still referring to <FIG>, the fluid coupling <NUM> in the depicted embodiment includes the mating components <NUM> and <NUM> in the form a male coupling-half <NUM> and a female coupling-half <NUM>. The male coupling-half <NUM> and the female coupling-half <NUM> are selectively matable to each other. The coupling halves <NUM> and <NUM> are shown coupled (connected) in <FIG>. The coupling halves <NUM> and <NUM> are shown uncoupled (disconnected) from each other in <FIG>. Each coupling-half <NUM> and <NUM>, as well as the assembled coupling <NUM> overall, defines a longitudinal axis <NUM>. Optionally, the male coupling-half <NUM> and the female coupling-half <NUM> are structured to be coupled using a bayonet-style connection. Accordingly, the male coupling-half <NUM> has two radially protruding posts 114a and 114b that are about <NUM>° opposed from each other. The female coupling-half <NUM> has two corresponding slots 164a and 164b that can receive the radially protruding posts 114a and 114b. Each slot 164a and 164b has an end-of-slot-aperture through which the radially protruding posts 114a and 114b can enter the slots 164a and 164b respectively.

To initiate the coupling of the coupling halves <NUM> and <NUM>, the radially protruding posts 114a and 114b must be oriented into alignment with the end-of-slot-apertures of the slots 164a and 164b. Then, the coupling halves <NUM> and <NUM> can be longitudinally pressed towards each other. In doing so, the radially protruding posts 114a and 114b enter into the slots 164a and 164b by passing through the end-of-slot-apertures of the slots 164a and 164b. Thereafter, the male coupling-half <NUM> can be rotated in relation to the female coupling-half <NUM>. The rotation causes the radially protruding posts 114a and 114b to travel within the slots 164a and 164b respectively. The coupling process is completed when the male coupling-half <NUM> has been rotated in relation to the female coupling-half <NUM> to the extent that the radially protruding posts 114a and 114b reach the ends of the slots 164a and 164b that are opposite from the end-of-slot-apertures of the slots 164a and 164b. In some embodiments, the bayonet connection is structured such that about <NUM>° of relative rotation between the male coupling-half <NUM> and the female coupling-half <NUM> will accomplish the bayonet-style coupling action.

In some embodiments, other types of coupling mechanisms and techniques are used for selectively coupling the male coupling-half <NUM> and the female coupling-half <NUM>. For example, in some embodiments threaded connections, detent connections, clamp connections, and the like, are used to selectively couple the male coupling-half <NUM> with the female coupling-half <NUM>.

While the coupling halves <NUM> and <NUM> are coupled as shown in <FIG>, an open fluid flow path is established through the coupling <NUM>. That is, in the operably coupled configuration, fluid can flow through the coupling <NUM> between a first connection <NUM> and a second connection <NUM>.

While the coupling <NUM> is in its operably coupled configuration, structural elements of the coupling <NUM> lock the coupling halves <NUM> and <NUM> in their respective operable positions. Therefore, to disconnect the coupling halves <NUM> and <NUM> from each other, the user is required to perform an unlocking procedure.

In the depicted embodiment, the procedure to unlock the coupling <NUM> is performed by manipulating a locking sleeve <NUM> that is slidably coupled to the male coupling-half <NUM>. Once the locking sleeve <NUM> has been slid (translated longitudinally) to a position near to the female coupling-half <NUM>, then the user can rotate the coupling halves <NUM> and <NUM> in relation to each other to disengage the bayonet connection. Conversely, until the locking sleeve <NUM> is slid (translated longitudinally) to a position near to the female coupling-half <NUM>, the coupling halves <NUM> and <NUM> cannot be rotated in relation to each other. Instead, the coupling halves <NUM> and <NUM> remain locked in the operably coupled configuration. That is the case at least because shuttle valve members within the coupling <NUM> have non-circular cross-sectional shapes, as described further below.

In the depicted embodiment, the locking sleeve <NUM> includes a first unlocking member 122a and a second unlocking member 122b (not visible). In some embodiments, the first unlocking member 122a and the second unlocking member 122b are oriented at about <NUM>° in relation to each other on the locking sleeve <NUM>. In the depicted embodiment, the unlocking members 122a and 122b must be simultaneously depressed in order to unlock the locking sleeve <NUM>, so that it can then be slid from its orientation in the operably coupled configuration (as shown in <FIG>) to a position near to the female coupling-half <NUM>. In the depicted embodiment, unless both unlocking members 122a and 122b are depressed simultaneously, the locking sleeve <NUM> cannot be slid towards the female coupling-half <NUM>.

In a summarized manner, the unlocking procedure of the depicted embodiment of coupling <NUM> is performed as follows. Beginning with the coupling <NUM> in the operably coupled configuration of <FIG>, the user first simultaneously depresses the first and second unlocking members 122a and 122b. While maintaining the first and second unlocking members 122a and 122b in their depressed orientations, the user then slides the locking sleeve <NUM> towards the female coupling-half <NUM>. When the unlocking sleeve <NUM> has been slid to its end of travel near the female coupling-half <NUM>, then the user can rotate the coupling halves <NUM> and <NUM> in relation to each other to disengage the bayonet connection. The user can then longitudinally separate the coupling halves <NUM> and <NUM> as depicted in <FIG>. It should be understood that this unlocking procedure, and the corresponding structural elements that facilitate this unlocking procedure, are merely examples of the kinds of unlocking procedures and structures that can be incorporated into various embodiments of the single-use, aseptic disconnection fluid coupling devices provided herein (of which the coupling <NUM> is one example).

While the coupling halves <NUM> and <NUM> are disconnected from each other as shown in <FIG>, fluids are blocked from flowing through the coupling halves <NUM> and <NUM> individually. That is, in the disconnected configuration, even though a fluid source is connected to the first connection <NUM> and/or to the second connection <NUM>, the fluid will not flow out of the coupling halves <NUM> and/or <NUM>. That is the case because, as described further below, a shuttle valve member in each of the coupling halves <NUM> and <NUM> blocks fluid from flowing out of the coupling halves <NUM> and <NUM> while the coupling halves <NUM> and <NUM> are disconnected from each other.

The face of the male coupling shuttle valve member <NUM> is visible in <FIG>. As shown, in the disconnected configuration the face of the male coupling shuttle valve member <NUM> is substantially flush with the end of the male coupling bore <NUM> in which the male coupling shuttle valve member <NUM> is slidably disposed.

As described further below, the shuttle valve members are individually slidable along a longitudinal path within bores of the coupling halves <NUM> and <NUM>, between open and fully closed positions. While the shuttle valve members <NUM> and <NUM> are in their fully closed positions, fluid is blocked from flowing out of the coupling halves <NUM> and <NUM>, and biological contaminants are blocked from entering into the fluid flow paths of the coupling halves <NUM> and <NUM>. <FIG> provides an illustration of the male coupling shuttle valve member <NUM> positioned in its fully closed position such that fluid is blocked from flowing out of the male coupling-half <NUM>, and biological contaminants are blocked from entering the fluid flow path of the male coupling-half <NUM>. The female coupling-half <NUM> also has a shuttle valve member (not visible in <FIG>) that functions in the same fashion as the male coupling shuttle valve member <NUM> within the male coupling-half <NUM>.

In some embodiments, one or more of the shuttle valve members have non-circular cross-sectional shapes. For example, in the depicted embodiment the shuttle valve members <NUM> and <NUM> have ovular cross-sectional shapes (as illustrated by the male coupling shuttle valve member <NUM>). As described further below, due to the ovular shape of the shuttle valve members <NUM> and <NUM>, the coupling halves <NUM> and <NUM> cannot be rotated in relation to each other unless the shuttle valve members <NUM> and <NUM> are each longitudinally located in their fully closed position. Accordingly, the coupling halves <NUM> and <NUM> cannot be disconnected from each other unless the shuttle valve members <NUM> and <NUM> are each in their fully closed position. One of skill in the art will recognize that this structure prevents biological contamination of the fluid flow paths of the coupling halves <NUM> and <NUM> because the coupling halves <NUM> and <NUM> can only be disconnected from each other if the shuttle valve members <NUM> and <NUM> are each in their fully closed position. In addition, as described further below, when the shuttle valve members <NUM> and <NUM> are in their fully closed position, the shuttle valve members <NUM> and <NUM> are locked (detained) therein. Hence, coupling <NUM> is referred to herein as an aseptic disconnect coupling.

In the depicted embodiment, the first connection <NUM> and the second connection <NUM> are illustrated as barbed connections. It should be understood that the first connection <NUM> and/or the second connection <NUM> can be any type of connection including, but not limited to, threaded fittings, sanitary flanges, compression fittings, luer fittings, luer-lock fittings, and the like. In some embodiments, the first connection <NUM> and the second connection <NUM> are dissimilar types of connections. In some embodiments, the first connection <NUM> and/or the second connection <NUM> facilitate multiple points of connection (e.g., a Y-fitting, a T-fitting, a manifold, and the like).

In some embodiments, the materials from which the components of the coupling <NUM> are made of include thermoplastics. In particular embodiments, the materials from which the components of the coupling <NUM> are made of are biocompatible thermoplastics, such as, but not limited to, polycarbonate, polysulphone, polyether ether ketone, polysulphide, polyester, polyphenylene, polyaryletherketone, and the like, and combinations thereof. In some embodiments, the coupling <NUM> is metallic-free. That is, in some embodiments no metallic materials are included in the coupling <NUM>. In some embodiments, no metallic springs are included in the coupling <NUM>. In various embodiments, substantially no components of the coupling <NUM> (other than one or more seals) are under mechanical stress while the coupling <NUM> is in the operably coupled configuration. In some embodiments, the seals are made of materials such as, but not limited to, silicone, fluoroelastomers (FKM), ethylene propylene diene monomer (EPDM), and the like.

Referring to <FIG>, the coupling <NUM> can be oriented in an operably coupled configuration such that a fluid flow path <NUM> extends between the first connection <NUM> and the second connection <NUM>. In the operably coupled configuration, as shown, the male coupling-half <NUM> and the female coupling-half <NUM> abut each other at a circumferential interface <NUM>. An o-ring seal <NUM> between the male coupling-half <NUM> and the female coupling-half <NUM> near the circumferential interface <NUM> provides a fluid seal.

The coupling <NUM> includes the male coupling shuttle valve member <NUM> and the female coupling shuttle valve member <NUM>. The shuttle valve members <NUM> and <NUM> are slidable in relation to the male coupling-half <NUM> and the female coupling-half <NUM>, along the longitudinal axis <NUM> of the coupling <NUM>.

In the operably coupled configuration, as shown, the male coupling shuttle valve member <NUM> and the female coupling shuttle valve member <NUM> are abutted, face-to-face, and are positioned longitudinally toward the male coupling-half <NUM>. It can be said that, while in the operably coupled configuration, the male coupling shuttle valve member <NUM> and the female coupling shuttle valve member <NUM> are longitudinally biased towards the male coupling-half <NUM> because their abutting faces are positioned longitudinally away from the circumferential interface <NUM> towards the side of the male coupling-half <NUM>.

The fluid flow through coupling <NUM> can be in the direction from the first connection <NUM> to the second connection <NUM>, or vice versa. The coupling <NUM> is not limited to having the fluid flow therethrough in one particular direction. Rather, fluid can flow through coupling <NUM> in either direction.

The flow path <NUM> from the first connection <NUM> to the second connection <NUM> (i.e., from top to bottom in <FIG>) passes through the coupling <NUM> as follows. Fluid enters the first connection <NUM> and passes into a first male coupling-half internal space <NUM> defined by the male coupling-half <NUM>. The flow path <NUM> then enters into an internal male coupling shuttle valve member space <NUM> defined by the male coupling shuttle valve member <NUM>. The flow path <NUM> then passes through one or more male coupling shuttle valve apertures <NUM> defined by the male coupling shuttle valve member <NUM> and into a second male coupling-half internal space <NUM> defined by the male coupling-half <NUM>. The flow path <NUM> then passes through one or more female coupling shuttle valve apertures <NUM> defined by the female coupling shuttle valve member <NUM> and into an internal female coupling shuttle valve member space <NUM> defined by the female coupling shuttle valve member <NUM>. The flow path <NUM> then enters a female coupling-half internal space <NUM> defined by the female coupling-half <NUM>, and then passes out through the second connection <NUM>.

The flow path <NUM> from the second connection <NUM> to the first connection <NUM> (i.e., from bottom to top in <FIG>) passes through the coupling <NUM> as follows. Fluid enters the second connection <NUM> and passes into the female coupling-half internal space <NUM> defined by the female coupling-half <NUM>. The flow path <NUM> then enters into the internal female coupling shuttle valve member space <NUM> defined by the female coupling shuttle valve member <NUM>. The flow path <NUM> then passes through one or more female coupling shuttle valve apertures <NUM> defined by the female coupling shuttle valve member <NUM> and into the second male coupling-half internal space <NUM> defined by the male coupling-half <NUM>. The flow path <NUM> then passes through one or more male coupling shuttle valve apertures <NUM> defined by the male coupling shuttle valve member <NUM> and into the internal male coupling shuttle valve member space <NUM> defined by the male coupling shuttle valve member <NUM>. The flow path <NUM> then enters the first male coupling-half internal space <NUM> defined by the male coupling-half <NUM>, and then passes out through the first connection <NUM>.

In some embodiments, the first connection <NUM> and/or the second connection <NUM> are formed integrally with the other portions of the male coupling-half <NUM> and/or the female coupling-half <NUM>. Alternatively, in some embodiments the first connection <NUM> and/or the second connection <NUM> are formed separately from other portions of the male coupling-half <NUM> and/or the female coupling-half <NUM>, and then subsequently affixed to the other portions of the male coupling-half <NUM> and/or the female coupling-half <NUM> respectively. Such a manufacturing technique can be referred to as modular construction. Joining techniques such as, but not limited to, ultrasonic welding, laser welding, solvent bonding, gluing, overmolding, insert molding, and the like, and combinations thereof, can be used to affix the first connection <NUM> and/or the second connection <NUM> with the other portions of the male coupling-half <NUM> and/or the female coupling-half <NUM>.

In the operably coupled configuration as shown, the coupling halves <NUM> and <NUM> cannot be rotated in relation to each other. That is the case because the female coupling shuttle valve member <NUM> (that has a non-circular cross-sectional shape) extends within the male coupling bore <NUM> and within a female coupling bore <NUM>. The bores of the male coupling bore <NUM> and the female coupling bore <NUM> have non-circular cross-section shapes that correspond to the non-circular cross-sectional shape of the female coupling shuttle valve member <NUM>. Hence, the coupling halves <NUM> and <NUM> cannot be rotated in relation to each other.

In the depicted embodiment, the female coupling shuttle valve member <NUM> has an ovular cross-sectional shape, and both the male coupling bore <NUM> and the female coupling bore <NUM> have ovular cross-sectional shapes that correspond to the ovular cross-sectional shape of the female coupling shuttle valve member <NUM>. This arrangement provides a keyed relationship between the coupling halves <NUM> and <NUM>, with the female coupling shuttle valve member <NUM> being the key. Hence, the coupling halves <NUM> and <NUM> cannot be rotated in relation to each other.

In the operably coupled configuration as shown, the locking sleeve <NUM> is locked in its longitudinal position on the male coupling-half <NUM>. As described above, the unlocking members 122a and 122b must be simultaneously depressed in order to unlock the locking sleeve <NUM> so that it can then be slid from its orientation in the operably coupled configuration to a position near to the female coupling-half <NUM>. Unless both unlocking members 122a and 122b are depressed, the locking sleeve <NUM> cannot be slid towards the female coupling-half <NUM>.

It should be understood from the foregoing description that, while the coupling <NUM> is in the operably coupled configuration, no reconfiguration of the coupling <NUM> is likely to occur unintentionally. That is the case, for example, because the coupling halves <NUM> and <NUM> cannot be rotated in relation to each other, and because the locking sleeve <NUM> cannot be slid from its orientation in the operably coupled configuration unless the unlocking members 122a and 122b are simultaneously depressed. Hence, without intentional actions of a user, the coupling <NUM> will steadfastly remain in its operably coupled configuration.

The arrangement and operation of the coupling <NUM> in its operably coupled configuration has now been described. The following figures and description will provide step-by-step details of techniques for disconnecting the male coupling-half <NUM> from the female coupling-half <NUM>. It should be understood from the following figures and description that the structure of the coupling <NUM> ensures that the coupling <NUM> provides a single-use, aseptic disconnection fluid coupling device that substantially prevents fluid discharge when being disconnected.

Referring to <FIG>, for the depicted embodiment of coupling <NUM>, the technique for disconnection of the male coupling-half <NUM> from the female coupling-half <NUM> begins with unlocking the locking sleeve <NUM> and then sliding the locking sleeve <NUM> towards the female coupling-half <NUM>. These figures show the position of the locking sleeve <NUM> after the locking sleeve <NUM> has been unlocked and slid fully towards the female coupling-half <NUM>.

In the depicted embodiment, the locking sleeve <NUM> cannot be slid longitudinally towards the female coupling-half <NUM> until the unlocking members 122a and 122b are both simultaneously held in a depressed arrangement. In some embodiments, other types of unlocking mechanisms are used.

While the unlocking members 122a and 122b are both simultaneously held in a depressed arrangement, the locking sleeve <NUM> can be slid longitudinally towards the female coupling-half <NUM>. As the locking sleeve <NUM> slides towards the female coupling-half <NUM>, an inner male coupling-half barrel member <NUM> slides within an outer male coupling-half barrel member <NUM> that remains stationary. The inner male coupling-half barrel member <NUM> is coupled with the locking sleeve <NUM>. Consequently, the inner male coupling-half barrel member <NUM> moves in conjunction with the locking sleeve <NUM>. The outer male coupling-half barrel member <NUM> remains stationary in relation to the female coupling-half <NUM> while the locking sleeve <NUM> and the inner male coupling-half barrel member <NUM> are translated longitudinally towards the female coupling-half <NUM>. An o-ring seal <NUM> is disposed between the inner male coupling-half barrel member <NUM> and the outer male coupling-half barrel member <NUM> to provide a fluid seal therebetween.

As the locking sleeve <NUM> and the inner male coupling-half barrel member <NUM> are translated longitudinally towards the female coupling-half <NUM>, the male coupling shuttle valve member <NUM> also translates longitudinally towards the female coupling-half <NUM>. That is the case because the male coupling shuttle valve member <NUM> is coupled to the inner male coupling-half barrel member <NUM>. Moreover, because the male coupling shuttle valve member <NUM> is abutted face-to-face with the female coupling shuttle valve member <NUM>, the female coupling shuttle valve member <NUM> is also forced to translate longitudinally towards the female coupling-half <NUM>.

The locking sleeve <NUM> is translated longitudinally towards the female coupling-half <NUM> until the position of the face-to-face abutment of the male coupling shuttle valve member <NUM> and the female coupling shuttle valve member <NUM> is longitudinally aligned with the circumferential interface <NUM> between the coupling halves <NUM> and <NUM>. This is the arrangement shown in <FIG>. When the shuttle valve members <NUM> and <NUM> reach the arrangement shown in <FIG>, both of the shuttle valve members <NUM> and <NUM> become detained in those respective positions (where the face-to-face abutment of the shuttle valve members <NUM> and <NUM> is longitudinally aligned with the circumferential interface <NUM>).

The arrangement shown in <FIG> results in a blockage of the previously existing flow path <NUM> (refer to <FIG>). That is, when the locking sleeve <NUM> is slid longitudinally to its end-of-travel position near to the female coupling-half <NUM> (as shown in <FIG>), a flow path no longer exists between the first connection <NUM> and the second connection <NUM>. Rather, the longitudinal sliding of the locking sleeve <NUM> to its end-of-travel position near to the female coupling-half <NUM> (as shown in <FIG>) eliminates the previously existing flow path <NUM> between the first connection <NUM> and the second connection <NUM>. What is more, because both of the shuttle valve members <NUM> and <NUM> become detained in their respective positions (as shown in <FIG>), the previously existing flow path <NUM> cannot be reestablished after the locking sleeve <NUM> is slid longitudinally to its end-of-travel position near to the female coupling-half <NUM>. Rather, the flow path <NUM> through coupling <NUM> is permanently blocked. Hence, coupling <NUM> is referred to as a single-use coupling.

As described above, prior to sliding the locking sleeve <NUM> to configure the coupling <NUM> in the arrangement shown in <FIG>, the female coupling shuttle valve member <NUM> extended within the male coupling bore <NUM> and within the female coupling bore <NUM>. Said differently, the female coupling shuttle valve member <NUM> (that has a non-circular cross-sectional shape) straddled the circumferential interface <NUM> between the coupling halves <NUM> and <NUM>. In that arrangement, the coupling halves <NUM> and <NUM> could not be rotated in relation to each other.

In the arrangement shown in <FIG>, however, the female coupling shuttle valve member <NUM> is no longer straddling the circumferential interface <NUM> between the coupling halves <NUM> and <NUM>. Rather, the face-to-face abutment of the male coupling shuttle valve member <NUM> and the female coupling shuttle valve member <NUM> is longitudinally aligned with the circumferential interface <NUM> between the coupling halves <NUM> and <NUM>. Consequently, rotation between the coupling halves <NUM> and <NUM> is no longer structurally prevented.

Referring to <FIG>, the next step in the process for disconnecting the coupling halves <NUM> and <NUM> from each other is rotation of the coupling halves <NUM> and <NUM> in relation to each other. Such a rotation will partly disengage the bayonet connection mechanism between the coupling halves <NUM> and <NUM>. <FIG> show the coupling halves <NUM> and <NUM> after the rotation has been completed.

As the coupling halves <NUM> and <NUM> are rotated in relation to each other, the two radially protruding posts 114a and 114b slide within the two corresponding slots 164a and 164b. In some embodiments, such as the depicted embodiment, the slots 164a and 164b are not orthogonal with the longitudinal axis <NUM>. Rather, in the depicted embodiment the slots 164a and 164b extend at a non-orthogonal angle <NUM> in relation to the longitudinal axis <NUM>. In some embodiments, the non-orthogonal angle <NUM> is in a range from about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°. In some embodiments, the slots 164a and 164b are generally orthogonal to the longitudinal axis <NUM>.

Because the slots 164a and 164b of the depicted embodiment extend along the non-orthogonal angle <NUM>, as the coupling halves <NUM> and <NUM> are rotated in relation to each other the coupling halves <NUM> and <NUM> will also translate longitudinally in relation to each other. That is, as the two radially protruding posts 114a and 114b are slid within the two corresponding slots 164a and 164b along the non-orthogonal angle <NUM> by the relative twisting of the coupling halves <NUM> and <NUM>, the two radially protruding posts 114a and 114b travel longitudinally and cause the male coupling-half <NUM> to also travel longitudinally (in relation to the female coupling-half <NUM>). Hence, the coupling halves <NUM> and <NUM> become slightly longitudinally separated from each other as the coupling halves <NUM> and <NUM> are rotated in relation to each other. This separation is visible in <FIG> and <FIG> at the circumferential interface <NUM>. A gap exists there between the male coupling-half <NUM> and the female coupling-half <NUM> where the two previously directly abutted each other.

The structures that result in the coupling halves <NUM> and <NUM> becoming slightly separated from each other as the coupling halves <NUM> and <NUM> are rotated in relation to each other can be advantageous in some cases. For example, the resulting slight separation may be advantageous for breaking a seal (or vacuum) that may exist between the coupling halves <NUM> and <NUM>, and that may otherwise be difficult or inconvenient for a user to break.

It is also apparent, by close observation near the area of the circumferential interface <NUM> in <FIG> and <FIG>, that the male coupling shuttle valve member <NUM> and the female coupling shuttle valve member <NUM> appear to have differing diameters. That appears to be the case in <FIG> and <FIG> because, as described above, the male coupling shuttle valve member <NUM> and the female coupling shuttle valve member <NUM> have non-circular cross-sectional shapes (ovular cross-sectional shapes in the depicted embodiment). The relative rotation between the coupling halves <NUM> and <NUM> also rotates the male coupling shuttle valve member <NUM> in relation to the female coupling shuttle valve member <NUM>. Hence, because of the perspective of the figures, the male coupling shuttle valve member <NUM> appears wider than the female coupling shuttle valve member <NUM> in <FIG>, and the male coupling shuttle valve member <NUM> appears narrower than the female coupling shuttle valve member <NUM> in <FIG>. In reality, in the depicted embodiment the male coupling shuttle valve member <NUM> and the female coupling shuttle valve member <NUM> have ovular cross-sectional shapes that are dimensionally equal to each other. Further, in some embodiments the male coupling shuttle valve member <NUM> and the female coupling shuttle valve member <NUM> are two of the very same physical design (shape), and are arranged as mirror images of each other (face-to-face) in the assembled coupling <NUM>.

As described above, each slot 164a and 164b has an end-of-slot-aperture through which the radially protruding posts 114a and 114b can pass, respectively. In the arrangement of <FIG>, the radially protruding posts 114a and 114b are longitudinally aligned with the end-of-slot-apertures of slots 164a and 164b respectively.

Referring to <FIG>, the coupling halves <NUM> and <NUM> of coupling <NUM> can be disconnected (uncoupled) from each other. With the radially protruding posts 114a and 114b longitudinally aligned with the end-of-slot-apertures of slots 164a and 164b respectively, the male coupling-half <NUM> can be separated from the female coupling-half <NUM> by simply pulling them apart longitudinally.

<FIG> and <FIG> illustrate that, when the coupling halves <NUM> and <NUM> are disconnected from each other, the face of the male coupling shuttle valve member <NUM> is substantially flush with the end of the male coupling bore <NUM>. Similarly, the face of the female coupling shuttle valve member <NUM> is substantially flush with the end of the female coupling bore <NUM>. In addition, <FIG> and <FIG> illustrate that an o-ring <NUM> is positioned between the male coupling shuttle valve member <NUM> and the male coupling bore <NUM>, near to the end of the male coupling bore <NUM>. Similarly, an o-ring <NUM> is positioned between the female coupling shuttle valve member <NUM> and the female coupling bore <NUM>, near to the end of the female coupling bore <NUM>.

The arrangement where the face of the male coupling shuttle valve member <NUM> is substantially flush with the end of the male coupling bore <NUM>, and the o-ring <NUM> is near to the end of the male coupling bore <NUM>, inhibits or substantially prevents biological contamination from entering the male coupling-half <NUM>. Similarly, the arrangement where the face of the female coupling shuttle valve member <NUM> is substantially flush with the end of the female coupling bore <NUM>, and the o-ring <NUM> is near to the end of the female coupling bore <NUM>, inhibits or substantially prevents biological contamination from entering the female coupling-half <NUM>. In other words, these structural features make coupling <NUM> an aseptic disconnection fluid coupling device.

In addition, the aforementioned arrangement regarding the faces of the coupling shuttle valve members <NUM> and <NUM> being substantially flush with the ends of the coupling bores <NUM> and <NUM>, and the o-rings <NUM> and <NUM> being near to the ends of the coupling bores <NUM> and <NUM> substantially prevents fluid discharge when the coupling halves <NUM> and <NUM> are being disconnected from each other.

When the coupling halves <NUM> and <NUM> have been disconnected from each other using the process described above, particular components of the coupling <NUM> are detained (effectively locked) in their respective positions. For example, the shuttle valve members <NUM> and <NUM> are detained in relation to the coupling bores <NUM> and <NUM>. In addition, the locking sleeve <NUM> is detained in its position longitudinally on the male coupling-half <NUM>. Hence, even if the bayonet connection between the coupling halves <NUM> and <NUM> is restored, the flow path through coupling <NUM> will not be reopened. For this reason, the coupling <NUM> is termed as a single-use coupling device. In other words, once the coupling halves <NUM> and <NUM> have been disconnected from each other, the coupling halves <NUM> and <NUM> cannot be reconnected so as to create a flow path through the coupling <NUM>.

The inventive concepts provided herein pertaining to single-use, aseptic disconnection fluid coupling devices can be further illustrated in the context of additional example embodiments. For example, <FIG> illustrate another example single-use, aseptic disconnection fluid coupling device <NUM> in accordance with some embodiments. Many of the functional characteristics of fluid coupling device <NUM> that make it a single-use, aseptic disconnection fluid coupling device are also shared by the aseptic disconnection fluid coupling device <NUM>. However, some of the particular mechanisms that facilitate the functionality of coupling device <NUM> as a single-use, aseptic disconnection fluid coupling device are in different from the particular mechanisms of coupling device <NUM>. This illustrates that many different types of mechanisms can be alternatively or additionally incorporated in the single-use, aseptic disconnection fluid coupling devices provided herein, and such variations are within the scope of the present disclosure.

<FIG> illustrates another example fluid system <NUM> that can include one or more example fluid coupling devices <NUM> configured to, for example, releasably connect the first fluid system equipment or container <NUM> to the second fluid system equipment or container <NUM>. In some implementations, the fluid system <NUM> may include at least one fluid coupling device <NUM> that is a single-use, aseptic disconnection fluid coupling device, in which first and second mating components <NUM> and <NUM> are configured to disconnect from one another in a manner that provides an aseptic disconnection, and that mechanically prevents reuse of the fluid path through the mating components <NUM> and <NUM>. (The first and second mating portions <NUM> and <NUM> are sometimes referred to herein as "coupling halves" or a "coupling-half" even though the components <NUM> and <NUM> are not necessarily equal halves in terms of size, shape, or weight. ) In one non-limiting example, the fluid coupling <NUM> can provide a single-use, aseptic disconnection capability for a fluid path between the fluid system equipment <NUM> in the form of a bioreactor system (connected directly to the coupling device <NUM> or connected via a fluid tube <NUM>) and the fluid system container <NUM> in the form of a media bag (connected directly to the coupling device <NUM> or connected via a fluid tube <NUM>).

Referring also to <FIG>, the fluid coupling <NUM> in the depicted embodiment includes the mating components <NUM> and <NUM> in the form a male coupling-half <NUM> and a female coupling-half <NUM>. The male coupling-half <NUM> and the female coupling-half <NUM> are selectively matable to each other. The coupling halves <NUM> and <NUM> are shown coupled (connected) in <FIG> and <FIG>. The coupling halves <NUM> and <NUM> are shown uncoupled (disconnected) from each other in <FIG>. Each coupling-half <NUM> and <NUM>, as well as the assembled coupling <NUM> overall, defines a longitudinal axis <NUM>. Optionally, the male coupling-half <NUM> and the female coupling-half <NUM> are structured to be coupled using a bayonet-style connection. Accordingly, the male coupling-half <NUM> has two radially protruding posts 214a and 214b that are about <NUM>° opposed from each other. The female coupling-half <NUM> has two corresponding slots 264a and 264b that can receive the radially protruding posts 214a and 214b. Each slot 264a and 264b has an end-of-slot-aperture through which the radially protruding posts 214a and 214b can enter the slots 264a and 264b respectively.

To initiate the coupling of the coupling halves <NUM> and <NUM>, the radially protruding posts 214a (not visible) and 214b must be oriented into alignment with the end-of-slot-apertures of the slots 264a (not visible) and 264b. Then, the coupling halves <NUM> and <NUM> can be longitudinally advanced towards each other. In doing so, the radially protruding posts 214a and 214b enter into the slots 264a and 264b by passing through the end-of-slot-apertures of the slots 264a and 264b. Thereafter, the male coupling-half <NUM> can be rotated in relation to the female coupling-half <NUM>. The rotation causes the radially protruding posts 214a and 214b to travel within the slots 264a and 264b respectively. The coupling process is completed when the male coupling-half <NUM> has been rotated in relation to the female coupling-half <NUM> to the extent that the radially protruding posts 214a and 214b reach the ends of the slots 264a and 264b that are opposite from the end-of-slot-apertures of the slots 264a and 264b. In some embodiments, the bayonet connection is structured such that about <NUM>° of relative rotation between the male coupling-half <NUM> and the female coupling-half <NUM> will accomplish the bayonet-style coupling action. In some embodiments, the bayonet connection is structured such that about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or about <NUM>°, or less than <NUM>° of relative rotation between the male coupling-half <NUM> and the female coupling-half <NUM> will accomplish the bayonet-style coupling action.

While the coupling halves <NUM> and <NUM> are coupled as shown in <FIG> and <FIG>, an open fluid flow path is established through the coupling <NUM>. That is, in the operably coupled configuration, fluid can flow through the coupling <NUM> between a first connection <NUM> and a second connection <NUM>. The open fluid flow path established through the coupling <NUM> is sealed. Accordingly, liquid(s) that are flowing through the coupling <NUM> are isolated from the environment outside of the fluid flow path, and the environment outside of the fluid flow path is isolated from the liquid(s) that are flowing through the coupling <NUM>. Hence, the coupling <NUM> is configured to operate as an aseptic coupling, and the sterility of the fluid flow path (in cases where the fluid flow path is sterile prior to use) can be maintained even if the environment outside of the fluid flow path is non-sterile.

While the coupling <NUM> is in its operably coupled configuration, structural elements of the coupling <NUM> releasably lock the coupling halves <NUM> and <NUM> in their respective operable positions. Therefore, to disconnect the coupling halves <NUM> and <NUM> from each other, the user is required to perform an unlocking procedure.

In the depicted embodiment, the procedure to unlock the coupling <NUM> is performed by manipulating a locking sleeve <NUM> that is slidably coupled to the male coupling-half <NUM>. Once the locking sleeve <NUM> has been slid (translated longitudinally) to a position near to the female coupling-half <NUM>, then the user can rotate the coupling halves <NUM> and <NUM> in relation to each other to disengage the bayonet connection. Conversely, until the locking sleeve <NUM> is slid (translated longitudinally) to a position near to the female coupling-half <NUM>, the coupling halves <NUM> and <NUM> cannot be rotated in relation to each other. Instead, the coupling halves <NUM> and <NUM> remain locked in the operably coupled configuration.

In the depicted embodiment, the locking sleeve <NUM> can be physically obstructed from sliding toward the female coupling-half <NUM> by the presence of a removable locking collar <NUM> that is latchable in the space between the locking sleeve <NUM> and the female coupling-half <NUM> as illustrated in <FIG>. The locking collar <NUM> can have various configurations. For example, as illustrated in <FIG>, in the depicted embodiment the locking collar <NUM> is a c-shaped element that is elastically flexible to facilitate convenient installation and/or removal of the locking collar <NUM> from its designated position between the locking sleeve <NUM> and the female coupling-half <NUM>. To decouple the coupling halves <NUM> and <NUM>, the locking collar <NUM> can be removed so that the locking sleeve <NUM> can then be longitudinally translated toward the female coupling-half <NUM>.

In a summarized manner, the unlocking procedure of the depicted embodiment of coupling <NUM> is performed as follows. Beginning with the coupling <NUM> in the operably coupled configuration of <FIG>, the user first removes the locking collar <NUM> as depicted in <FIG>. The user then slides the locking sleeve <NUM> towards the female coupling-half <NUM>. When the unlocking sleeve <NUM> has been slid to its end of travel near the female coupling-half <NUM>, then the user can rotate the coupling halves <NUM> and <NUM> in relation to each other to disengage the bayonet connection. The user can then longitudinally separate the coupling halves <NUM> and <NUM> as depicted in <FIG>. It should be understood that this unlocking procedure, and the corresponding structural elements that facilitate this unlocking procedure, are merely examples of the kinds of unlocking procedures and structures that can be incorporated into various embodiments of the single-use, aseptic disconnection fluid coupling devices provided herein (of which the coupling <NUM> is one example).

As described further below, the shuttle valve members are individually slidable along a longitudinal path within bores of the coupling halves <NUM> and <NUM>, between open and fully closed positions. While the shuttle valve members <NUM> and <NUM> are in their fully closed positions (and during the process of decoupling the coupling halves <NUM> and <NUM> which moves the shuttle valve members <NUM> and <NUM> to their fully closed positions), fluid is blocked from flowing out of the coupling halves <NUM> and <NUM>, and biological contaminants are blocked from entering into the fluid flow paths of the coupling halves <NUM> and <NUM>. In the depicted embodiment of coupling <NUM>, the shuttle valve members <NUM> and <NUM> have circular cross-sectional shapes (as opposed to the ovular shapes of the shuttle valve members <NUM> and <NUM> described above in reference to coupling <NUM>).

In some embodiments, the materials from which the components of the coupling <NUM> are made of include thermoplastics. In particular embodiments, the materials from which the components of the coupling <NUM> are made of are biocompatible thermoplastics, such as, but not limited to, polycarbonate, polysulfone, polyether ether ketone, polysulphide, polyester, polyphenylene, polyaryletherketone, and the like, and combinations thereof. In some embodiments, the coupling <NUM> is metallic-free. That is, in some embodiments no metallic materials are included in the coupling <NUM>. In some embodiments, no metallic springs are included in the coupling <NUM>. In various embodiments, substantially no components of the coupling <NUM> (other than stresses associated with the one or more seals) are under mechanical stress while the coupling <NUM> is in the operably coupled configuration. In some embodiments, the seals are made of materials such as, but not limited to, silicone, fluoroelastomers (FKM), ethylene propylene diene monomer (EPDM), and the like.

The coupling <NUM> includes the male coupling shuttle valve member <NUM> and the female coupling shuttle valve member <NUM>. The shuttle valve members <NUM> and <NUM> are slidable in relation to the male coupling-half <NUM> and the female coupling-half <NUM>, along the longitudinal axis <NUM> of the coupling <NUM>. In the depicted embodiment, the shuttle valve members <NUM> and <NUM> have circular cross-sectional shapes.

In the operably coupled configuration, as shown, the male coupling shuttle valve member <NUM> and the female coupling shuttle valve member <NUM> are abutted, face-to-face, and are positioned longitudinally toward the male coupling-half <NUM> (in comparison to the circumferential interface <NUM>). It can be said that, while in the operably coupled configuration, the male coupling shuttle valve member <NUM> and the female coupling shuttle valve member <NUM> are longitudinally biased towards the male coupling-half <NUM> because their abutting faces are positioned longitudinally away from the circumferential interface <NUM> towards the side of the male coupling-half <NUM>.

The flow path <NUM> from the first connection <NUM> to the second connection <NUM> (i.e., from bottom to top in <FIG> and <FIG>) passes through the coupling <NUM> as follows. Fluid enters the first connection <NUM> and passes into a first male coupling-half internal space <NUM> defined by the male coupling-half <NUM>. The flow path <NUM> then enters into an internal male coupling shuttle valve member space <NUM> defined by the male coupling shuttle valve member <NUM>. The flow path <NUM> then passes through one or more male coupling shuttle valve apertures <NUM> defined by the male coupling shuttle valve member <NUM> and into a second male coupling-half internal space <NUM> defined by the male coupling-half <NUM>. The flow path <NUM> then passes through one or more female coupling shuttle valve apertures <NUM> defined by the female coupling shuttle valve member <NUM> and into an internal female coupling shuttle valve member space <NUM> defined by the female coupling shuttle valve member <NUM>. The flow path <NUM> then enters a female coupling-half internal space <NUM> defined by the female coupling-half <NUM>, and then passes out through the second connection <NUM>.

The flow path <NUM> from the second connection <NUM> to the first connection <NUM> (i.e., from top to bottom in <FIG> and <FIG>) passes through the coupling <NUM> as follows. Fluid enters the second connection <NUM> and passes into the female coupling-half internal space <NUM> defined by the female coupling-half <NUM>. The flow path <NUM> then enters into the internal female coupling shuttle valve member space <NUM> defined by the female coupling shuttle valve member <NUM>. The flow path <NUM> then passes through one or more female coupling shuttle valve apertures <NUM> defined by the female coupling shuttle valve member <NUM> and into the second male coupling-half internal space <NUM> defined by the male coupling-half <NUM>. The flow path <NUM> then passes through one or more male coupling shuttle valve apertures <NUM> defined by the male coupling shuttle valve member <NUM> and into the internal male coupling shuttle valve member space <NUM> defined by the male coupling shuttle valve member <NUM>. The flow path <NUM> then enters the first male coupling-half internal space <NUM> defined by the male coupling-half <NUM>, and then passes out through the first connection <NUM>.

Referring also to <FIG> (with locking collar <NUM> not shown), while the fluid coupling <NUM> is in its operably coupled configuration as shown, the coupling halves <NUM> and <NUM> cannot be rotated in relation to each other. That is the case because a projection <NUM> that is affixed to the male coupling-half <NUM> is rotationally captured between a latch member <NUM> and a wall <NUM> that are both attached to the female coupling-half <NUM>. Accordingly, as described further below, the coupling halves <NUM> and <NUM> cannot be rotated in relation to each other until the locking sleeve <NUM> has been slid (translated longitudinally) to a position near to the female coupling-half <NUM>. Then, while the locking sleeve <NUM> is at its end of travel position near to the female coupling-half <NUM>, the latch member <NUM> will be actuated so that the projection <NUM> will no longer be detained by the latch member <NUM>. In that arrangement, as described further below, the user can rotate the coupling halves <NUM> and <NUM> in relation to each other to disengage the bayonet connection. Conversely, until the locking sleeve <NUM> is slid (translated longitudinally) to its end of travel position near to the female coupling-half <NUM>, the coupling halves <NUM> and <NUM> cannot be rotated in relation to each other. Instead, the coupling halves <NUM> and <NUM> remain locked in the operably coupled configuration.

Still referring to <FIG>, in the operably coupled configuration as shown, the locking sleeve <NUM> is detained in its longitudinal position on the male coupling-half <NUM> by the locking collar <NUM>. As described above, the locking collar <NUM> must be removed in order to allow the locking sleeve <NUM> to be slid from its orientation in the operably coupled configuration to a position near to the female coupling-half <NUM>. Unless the locking collar <NUM> is removed from between the locking sleeve <NUM> and the female coupling-half <NUM>, the locking sleeve <NUM> cannot be slid towards the female coupling-half <NUM>.

It should be understood from the foregoing description that, while the coupling <NUM> is in the operably coupled configuration, no reconfiguration of the coupling <NUM> is likely to occur unintentionally. That is the case, for example, because the coupling halves <NUM> and <NUM> cannot be rotated in relation to each other, and because the locking sleeve <NUM> cannot be slid from its orientation in the operably coupled configuration unless the locking collar <NUM> is removed from between the locking sleeve <NUM> and the female coupling-half <NUM>. Hence, without intentional actions of a user, the coupling <NUM> will steadfastly remain in its operably coupled configuration.

Referring to <FIG>, for the depicted embodiment of coupling <NUM>, the technique for disconnection of the male coupling-half <NUM> from the female coupling-half <NUM> begins with removing the locking collar <NUM> and then sliding the locking sleeve <NUM> towards the female coupling-half <NUM>. These figures show the position of the locking sleeve <NUM> after the locking sleeve <NUM> has been slid fully towards the female coupling-half <NUM>.

In the depicted embodiment, the locking sleeve <NUM> cannot be slid longitudinally towards the female coupling-half <NUM> until the locking collar <NUM> has been physically removed from the rest of the coupling <NUM>. In some embodiments, other types of mechanisms are used for locking/unlocking the locking sleeve <NUM>.

As the locking sleeve <NUM> is translated toward the female coupling-half <NUM>, an inner male coupling-half barrel member <NUM> slides within an outer male coupling-half barrel member <NUM> that remains stationary. The inner male coupling-half barrel member <NUM> is coupled with the locking sleeve <NUM>. Consequently, the inner male coupling-half barrel member <NUM> moves in conjunction with the locking sleeve <NUM>. The outer male coupling-half barrel member <NUM> remains stationary in relation to the female coupling-half <NUM> while the locking sleeve <NUM> and the inner male coupling-half barrel member <NUM> are translated longitudinally toward the female coupling-half <NUM>. An o-ring seal <NUM> is disposed between the inner male coupling-half barrel member <NUM> and the outer male coupling-half barrel member <NUM> to provide a fluid seal therebetween.

As the locking sleeve <NUM> and the inner male coupling-half barrel member <NUM> are translated longitudinally toward the female coupling-half <NUM>, the male coupling shuttle valve member <NUM> also translates longitudinally towards the female coupling-half <NUM>. That is the case because the male coupling shuttle valve member <NUM> is coupled to the inner male coupling-half barrel member <NUM>. Moreover, because the male coupling shuttle valve member <NUM> is abutted face-to-face with the female coupling shuttle valve member <NUM>, the female coupling shuttle valve member <NUM> is also forced to translate longitudinally towards the female coupling-half <NUM>.

The locking sleeve <NUM> can be manually translated longitudinally towards the female coupling-half <NUM> until the position of the face-to-face abutment of the male coupling shuttle valve member <NUM> and the female coupling shuttle valve member <NUM> is longitudinally aligned with the circumferential interface <NUM> between the coupling halves <NUM> and <NUM>. This is the arrangement shown in <FIG>. When the shuttle valve members <NUM> and <NUM> reach the arrangement shown in <FIG>, both of the shuttle valve members <NUM> and <NUM> become detained in those respective positions (where the face-to-face abutment of the shuttle valve members <NUM> and <NUM> is longitudinally aligned with the circumferential interface <NUM>).

The arrangement shown in <FIG> results in a blockage of the previously existing flow path <NUM> (refer to <FIG> and <FIG>). That is, when the locking sleeve <NUM> is slid longitudinally to its end-of-travel position near to the female coupling-half <NUM> (as shown in <FIG>), a flow path no longer exists between the first connection <NUM> and the second connection <NUM>. Rather, the longitudinal sliding of the locking sleeve <NUM> to its end-of-travel position near to the female coupling-half <NUM> (as shown in <FIG>) eliminates the previously existing flow path <NUM> between the first connection <NUM> and the second connection <NUM>. What is more, because both of the shuttle valve members <NUM> and <NUM> become detained in their respective positions (as shown in <FIG>), the previously existing flow path <NUM> cannot be reestablished after the locking sleeve <NUM> is slid longitudinally to its end-of-travel position near to the female coupling-half <NUM>. Rather, the flow path <NUM> through coupling <NUM> is permanently blocked. Hence, coupling <NUM> is referred to as a single-use coupling.

In some embodiments, the locking sleeve <NUM> is configured to be detained in its end-of-travel positions. For example, in the depicted embodiment the locking sleeve <NUM> includes one or more inward projection(s) <NUM> that can mate with either of a first recess 219a or a second recess 219b (or multiples thereof) that are defined by the outer male coupling-half barrel member <NUM>. Prior to sliding the locking sleeve <NUM> to its end-of-travel position near to the female coupling-half <NUM>, the inward projection(s) <NUM> can be releasably engaged with the first recess 219a. Then, while the locking sleeve <NUM> is at its end-of-travel position near to the female coupling-half <NUM>, the inward projection(s) <NUM> can be un-releasably engaged with the second recess 219b (see also <FIG>).

The inward projection(s) <NUM> and the complementary second recess 219b can be configured to latch-ably detain the locking sleeve <NUM> in its end-of-travel position near to the female coupling-half <NUM>. For example, in the depicted embodiment the inward projection(s) <NUM> and the complementary second recess 219b are ramped or beveled on the leading end but not on the trailing end. Hence, when the inward projection(s) <NUM> engages with the complementary second recess 219b, the locking sleeve <NUM> will be latched and un-releasably detained in its end-of-travel position near to the female coupling-half <NUM>.

In the depicted embodiment, the coupling halves <NUM> and <NUM> cannot be rotated in relation to each other unless the shuttle valve members <NUM> and <NUM> are each longitudinally located in their fully closed position. It follows that the coupling halves <NUM> and <NUM> cannot be disconnected from each other unless the shuttle valve members <NUM> and <NUM> are each in their fully closed position. One of skill in the art will recognize that this structure prevents biological contamination of the fluid flow paths of the coupling halves <NUM> and <NUM> because the coupling halves <NUM> and <NUM> can only be disconnected from each other if the shuttle valve members <NUM> and <NUM> are each in their fully closed position. In addition, as described further below, when the shuttle valve members <NUM> and <NUM> are in their fully closed position, the shuttle valve members <NUM> and <NUM> are locked (detained) therein. Hence, coupling <NUM> is referred to herein as a single-use, aseptic disconnect coupling.

As described above, prior to sliding the locking sleeve <NUM> to configure the coupling <NUM> in the arrangement shown in <FIG>, the coupling halves <NUM> and <NUM> could not be rotated in relation to each other. However, with the locking sleeve <NUM> at its end of travel position near to the female coupling-half <NUM>, relative rotation between the coupling halves <NUM> and <NUM> is no longer structurally prevented.

Referring also to <FIG>, relative rotation between the coupling halves <NUM> and <NUM> is no longer structurally prevented when the locking sleeve <NUM> is at its end of travel position near to the female coupling-half <NUM>. That is the case because the latch member <NUM> becomes actuated by virtue of positioning the locking sleeve <NUM> at its end of travel position near to the female coupling-half <NUM>. More particularly, locking sleeve <NUM> includes a latch actuation member <NUM> that makes contact with the latch member <NUM> when the locking sleeve <NUM> is at its end of travel position near to the female coupling-half <NUM>. For example, in the depicted embodiment the latch actuation member <NUM> includes a beveled leading end that deflects the latch member <NUM> out of the way of the projection <NUM>. Then, the latch member <NUM> no longer restrains the projection <NUM> from rotational movement. Rotation of the male coupling-half <NUM> in relation to the female coupling-half <NUM> can take place by rotating the projection <NUM> away from the wall <NUM> as depicted by an arrow <NUM>.

As the coupling halves <NUM> and <NUM> are rotated in relation to each other, the two radially protruding posts 214a and 214b slide within the two corresponding slots 264a and 264b. In some embodiments, such as the depicted embodiment, the slots 264a and 264b are not totally orthogonal with the longitudinal axis <NUM>. Rather, in the depicted embodiment a portion of the slots 264a and 264b extends at a non-orthogonal angle <NUM> in relation to the longitudinal axis <NUM>. In some embodiments, the non-orthogonal angle <NUM> is in a range from about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°, or about <NUM>° to about <NUM>°. In some embodiments, the slots 264a and 264b are generally orthogonal to the longitudinal axis <NUM>.

Because the slots 264a and 264b of the depicted embodiment extend along the non-orthogonal angle <NUM>, as the coupling halves <NUM> and <NUM> are rotated in relation to each other the coupling halves <NUM> and <NUM> will also translate longitudinally in relation to each other. That is, as the two radially protruding posts 214a and 214b are slid within the two corresponding slots 264a and 264b along the non-orthogonal angle <NUM> by the relative twisting of the coupling halves <NUM> and <NUM>, the two radially protruding posts 214a and 214b travel longitudinally and cause the male coupling-half <NUM> to also travel longitudinally (in relation to the female coupling-half <NUM>). Hence, the coupling halves <NUM> and <NUM> become slightly longitudinally separated from each other as the coupling halves <NUM> and <NUM> are rotated in relation to each other. This separation is visible in <FIG> at the circumferential interface <NUM>. A gap exists there between the male coupling-half <NUM> and the female coupling-half <NUM> where the two previously directly abutted each other.

As described above, each slot 264a and 264b has an end-of-slot-aperture through which the radially protruding posts 214a and 214b can pass, respectively. In the arrangement of <FIG>, the radially protruding posts 214a and 214b are longitudinally aligned with the end-of-slot-apertures of slots 264a and 264b respectively.

Referring to <FIG>, the coupling halves <NUM> and <NUM> of coupling <NUM> can be disconnected (uncoupled) from each other. With the radially protruding posts 214a and 214b longitudinally aligned with the end-of-slot-apertures of slots 264a and 264b respectively, the male coupling-half <NUM> can be separated from the female coupling-half <NUM> by simply pulling them apart longitudinally.

<FIG> illustrates that, when the coupling halves <NUM> and <NUM> are disconnected from each other, the face of the male coupling shuttle valve member <NUM> is substantially flush with the end of the male coupling bore <NUM>. Similarly, the face of the female coupling shuttle valve member <NUM> is substantially flush with the end of the female coupling bore <NUM>. In addition, <FIG> illustrates that an o-ring <NUM> is positioned between the male coupling shuttle valve member <NUM> and the male coupling bore <NUM>, near to the end of the male coupling bore <NUM>. Similarly, an o-ring <NUM> is positioned between the female coupling shuttle valve member <NUM> and the female coupling bore <NUM>, near to the end of the female coupling bore <NUM>.

When the coupling halves <NUM> and <NUM> have been disconnected from each other using the process described above, particular components of the coupling <NUM> are detained (effectively locked) in their respective positions. For example, the shuttle valve members <NUM> and <NUM> are detained in relation to the coupling bores <NUM> and <NUM>. In addition, the locking sleeve <NUM> is detained in its position longitudinally on the male coupling-half <NUM>. Hence, even if the bayonet connection between the coupling halves <NUM> and <NUM> is restored, the flow path through coupling <NUM> will not be reopened. For this reason, the coupling <NUM> is termed as a single-use coupling device. In other words, once the coupling halves <NUM> and <NUM> have been disconnected from each other, the coupling halves <NUM> and <NUM> cannot be reconnected so as to recreate a flow path through the coupling <NUM>.

Claim 1:
A fluid coupling device (<NUM>; <NUM>) comprising:
a male connector component (<NUM>; <NUM>) including a male coupling shuttle valve member (<NUM>; <NUM>) that is slidable along a longitudinal axis (<NUM>) of the male connector component (<NUM>; <NUM>); and
a female connector component (<NUM>; <NUM>) including a female coupling shuttle valve member (<NUM>; <NUM>) that is slidable along a longitudinal axis (<NUM>; <NUM>) of the female connector component (<NUM>),
wherein the male and female connector components are coupleable in a first arrangement in which an open flow path exists through each of the male and female connector components and in a second arrangement in which:
i) the male coupling shuttle valve member (<NUM>; <NUM>) is permanently locked in an end-of-travel position in which the male coupling shuttle valve member (<NUM>) blocks flow through the male connector component (<NUM>; <NUM>) and
ii) the female coupling shuttle valve member (<NUM>; <NUM>) is permanently locked in an end-of-travel position in which the female coupling shuttle valve member (<NUM>; <NUM>) blocks flow through the female connector component (<NUM>; <NUM>).