This document relates to fluid coupling devices for fluid systems and methods of using the fluid coupling devices. For example, some embodiments described in this document relate to genderless fluid couplings that can be used to provide a sterile connection for drug delivery.
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.
Some fluid couplings can be used in a medical context, such as for connecting a source of a therapeutic agent (or “drug”) to an intravenous drug delivery system. In some cases, the steps for intravenously delivering a drug to a patient can include: (i) connecting a syringe to a bottle or vial containing a drug, (ii) transferring an amount of the drug from the bottle into the syringe, (iii) disconnecting the syringe from the bottle, (iv) connecting the syringe to an intravenous (IV) bag and/or tubing, and then (v) delivering the drug via the IV tubing to the patient.
This document describes fluid coupling devices for fluid systems and methods. For example, in some embodiments this document describes genderless fluid couplings that can be used to provide a sterile connection for drug delivery.
In some embodiments, the fluid coupling devices can be implemented as multi-use, sterile fluid coupling devices that are configured to reduce the likelihood of fluid spillage when being disconnected. The fluid coupling devices described herein also minimize dead space so that a minimal amount of fluid is retained in the coupling devices after use.
Additionally, in some such multi-use embodiments or in other embodiments, the fluid coupling devices can be configured as “sterile” or “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 multi-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 aspect, this disclosure is directed to a fluid coupling device that includes: (i) a housing defining an internal space and a lumen configured for fluid flow, the lumen defining a central axis; (ii) a seal member affixed to the housing and including an upper surface exposed to the internal space, the seal member defining a through-hole in alignment with the lumen; and (iii) a shuttle disposed within the internal space and slidable relative to the housing along a path that intersects the central axis. The shuttle is slidable between: (i) a first position in which the shuttle is abutted against the upper surface of the seal member to cover the through-hole and prevent fluid flow through the lumen, and (ii) a second position in which the shuttle is spaced apart from and out of contact with the seal member.
Such a fluid coupling device may optionally include one or more of the following features. The fluid coupling device may also include a spring disposed between the housing and the shuttle. The spring may bias the shuttle toward the first position. The fluid coupling may also include a latch member attached to the housing. The latch member may detain the shuttle member in the first position as the spring pushes the shuttle member into contact against the latch member. The latch member may be manually pivotable relative to the shuttle member. The path that the shuttle slides along relative to the housing may be orthogonal to the central axis. The seal member may include a circular rib that is concentric with the through-hole. In some embodiments, the seal member includes two circular ribs that are each concentric with the through-hole. In some embodiments, while the shuttle is in the second position, the through-hole is open to the internal space. The cross-sectional shape of the internal space taken parallel to the central axis may be semicircular. The cross-sectional shape of the shuttle taken parallel to the central axis may be semicircular. The housing may have a semicircular front face with a size that matches the cross-sectional shape of the shuttle.
In another aspect, this disclosure is directed to a fluid coupling system that includes a first fluid coupling device and a second fluid coupling device that is identical to the first fluid coupling device. The first fluid coupling device may include a first housing defining a first internal space and a first lumen configured for fluid flow, the first lumen defining a first central axis; a first seal member affixed to the first housing and including a first upper surface exposed to the first internal space, the first seal member defining a first through-hole in alignment with the first lumen; and a first shuttle disposed within the first internal space and slidable relative to the first housing along a first path that intersects the first central axis, the first shuttle being slidable between: (i) a first position in which the first shuttle is abutted against the first upper surface of the first seal member to cover the first through-hole and prevent fluid flow through the first lumen, and (ii) a second position in which the first shuttle is spaced apart from and out of contact with the first seal member.
Such a fluid coupling system may optionally include one or more of the following features. In some embodiments, the first and second fluid couplings are slidable relative to each other into a coupled arrangement that defines an open fluid flow path therethrough. The first housing and the second housing may each have a front face. A shape of the front face may match a shape of an end of the first shuttle and an end of the second shuttle. The first and second fluid coupling devices may be coupleable by: (i) aligning the first and second fluid coupling devices such that the front face of the first housing is in contact with the second shuttle and the front face of the second housing is in contact with the first shuttle, and (ii) pushing the first and second fluid coupling devices toward each other to slide the first and second shuttles to their second positions. When the first and second shuttles are in their second positions the first and second through-holes may be in alignment with each other. The first fluid coupling device may include a first latch member, and the second fluid coupling device may include a second latch member. When the first and second shuttles are in their second positions: (i) the first latch member may be releasably engaged with the second housing and (ii) the second latch member may be releasably engaged with the first housing. The first latch member may be manually pivotable relative to the first housing, and the second latch member may be manually pivotable relative to the second housing. When the first and second fluid coupling devices are uncoupled from each other, a first spring of the first fluid coupling device may force the first shuttle into engagement against the first latch member and the first latch member may detain the first shuttle in the first position against the forces of the first spring.
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 facilitate a greater number of sterile connections as compared to conventional connection means (e.g., a needle piercing a silicon membrane or septum).
Second, in some embodiments, the fluid coupling devices described herein may advantageously reduce the amount of dead volume in the fluid coupling system.
Third, some embodiments of the fluid coupling devices provided herein are genderless couplings, meaning that a pair of two single couplings that are identical are conveniently used to make the fluid connection, rather than requiring specific male and female couplings.
Fourth, some embodiments of the fluid coupling devices provide an improved aseptic connection and 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 connection and/or 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 latching system. That is, when the two halves of the coupling are operably connected with each other, they are also mechanically latched or locked together. In some embodiments, to release the lock, two levers must be simultaneously depressed. This redundant requirement (e.g., simultaneous actuation of two levers or other actuators) for unlocking the coupling halves may reduce the likelihood of unintentional disconnections.
Sixth, in some embodiments the fluid couplings described herein are configured to reduce the likelihood of fluid spillage when being disconnected. Further, the fluid couplings described herein are designed to prevent the inclusion of air into the fluid, as can often result during the process of joining male and female couplings together.
Seventh, some embodiments do not have springs in the flow path.
Eighth, some embodiments have a smooth, unobstructed flow path.
In the context of this disclosure, the term “fluid” includes gases, liquids, and powders.
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. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.
Like reference numbers represent corresponding parts throughout.
This document describes fluid coupling devices for fluid systems and methods. For example, in some embodiments this document describes genderless fluid couplings that can be used to provide a sterile connection for drug delivery. In some embodiments, the fluid coupling devices can be implemented as multi-use, sterile fluid coupling devices that are configured to reduce the likelihood of fluid spillage when being disconnected.
The couplings and coupling systems described herein solve, for example, some issues related to repeatably providing a sterile connection for drug delivery. The couplings and coupling systems described herein achieve this by use of a wiping seal and a minimum number of components. The coupling device is also a genderless connector (meaning there are no traditional male and female halves). These attributes (e.g., the minimum number of components and the genderless arrangement) combine to provide a solution that can be mass manufactured cost-effectively.
Referring to
The materials from which one or more of the components of the fluid coupling 100 are made of include thermoplastics. In particular embodiments, the materials from which the components of the fluid coupling 100 are made of are thermoplastics, such as, but not limited to, acetal, polycarbonate, polysulfone, polyether ether ketone, polysulphide, polyester, polyvinylidene fluoride (PVDF), polyethylene, polyphenylsulfone (PPSU; e.g., Radel®), polyetherimide (PEI; e.g., Ultem®), polypropylene, polyphenylene, polyaryletherketone, and the like, and combinations thereof.
In some embodiments, the materials from which one or more of the components of the fluid coupling 100 are made of include metals such as, but not limited to stainless steel, brass, aluminum, plated steel, and the like. In particular embodiments, the fluid coupling 100 is metallic-free.
In some embodiments, the spring 140 is made of a metallic material (e.g., spring steel, stainless steel such as 316L, and the like). In some embodiments, the spring 140 can be made of a polymeric or elastomeric material.
In certain embodiments, the seal member 130 can be made of materials such as, but not limited to, silicone, fluoroelastomers (FKM), ethylene propylene diene monomer (EPDM), thermoplastic elastomers (TPE), buna, buna-N, thermoplastic vulcanizates (TPV), and the like.
The shuttle 120 is slidably coupled in relation to the housing 110. That is, the shuttle 120 can slide within a space defined by the housing 110.
The spring 140 is disposed between the housing 110 and the shuttle 120. The spring 140 biases the shuttle 120 to its first end of travel position (as shown) and resists (but allows) the shuttle 120 to be slid in relation to the housing 110 toward its opposite, second end of travel position. As the shuttle 120 is slid in relation to the housing 110 (away from its depicted end of travel position) the spring 140 become further compressed.
The housing 110 includes a fluid connection or termination 118 that can be configured in any desired manner (e.g., as a luer fitting, a barbed connection, a threaded connection, as any type of adapter, a sanitary fitting, etc.). The termination 118 defines a lumen 119. The lumen 119 provides the fluid flow path of the fluid coupling 100 when two fluid couplings 100 are fully coupled together (as described further below). The lumen 119 is blocked and fluidly sealed-off by the shuttle 120 in the depicted configuration.
Referring also to
The seal member 130 defines a through-hole 132. The through-hole 132 is aligned with the lumen 119. Accordingly, the lumen 119 and the through-hole 132 of the seal member 130 provide the fluid flow path of the fluid coupling 100 when two fluid couplings 100 are fully coupled together (as described further below).
When the shuttle 120 is in its first end of travel position (e.g., as depicted in
As shown in
In the depicted embodiment, the cross-sectional shape of the internal space 112 is semicircular (and the shuttle 120 has a slightly smaller semicircular outer profile). In addition, the cross-sectional shape of a front face 113 of the housing is also semicircular and the same size as the shuttle 120. Alternatively, other cross-sectional shapes can be used such as, but not limited to, rectangular, triangular, polygonal, and so on.
Still referring in particular to
The latch member 114 includes a first end that includes at least one projection 115 and an opposite, second end that includes a depressible arm 117. The latch support members 116a and 116b are each attached to the latch member 114 between the first and second ends of the latch member 114.
When the depressible arm 117 is manually depressed by a user of the fluid coupling 100, the latch member 114 will pivot. As the latch member 114 pivots, the first end that includes the at least one projection 115 will pivot in an upward direction away from the seal member 130 (in a direction opposite of the depressible arm 117 as it is depressed).
In the depicted embodiment, when the depressible arm 117 is manually depressed the latch support members 116a and 116b will twist to allow the latch member 114 to pivot. Then, when the force from the manual depression of the depressible arm 117 is removed, the latch support members 116a and 116b will rebound (naturally untwist) to return the latch member 114 to the depicted arrangement. In some embodiments, the housing 110 (including the latch member 114 and latch support members 116a and 116b) is a monolithic, unitary component (e.g., injection molded). Accordingly, the latch support members 116a and 116b can be said to provide a living hinge (or living torsion springs) type of connection for the latch member 114 to the rest of the housing 110. In some embodiments, the housing 110 can be constructed from separate but coupled components rather than being monolithic.
As visible in
Now referring to
In this cross-sectional view, it can be seen that the shuttle 120a is engaged against the seal member 130a, and the shuttle 120b is engaged against the seal member 130b. Accordingly, the lumens 119a and 119b are blocked and fluidly sealed at the interface between the shuttles 120a-b and seal members 130a-b. The shuttles 120a-b and seal members 130a-b act as valves.
In this view, it can also be seen that the housing 110a of the first coupling 100a defines a groove 111a, and the housing 110b of the second coupling 100b defines a groove 111b. These grooves 111a and 111b will be used to latch the couplings 100a and 100b together, as described further below.
Now referring also to
By comparing the uncoupled arrangement of
As the first coupling 100a and the second coupling 100b are pushed toward each other to operatively couple the first coupling 100a and the second coupling 100b, the latch members 114a-b do not need to be manually manipulated. Then, when the first coupling 100a and the second coupling 100b are fully coupled together, the at least one projection 115a-b (
To uncouple the first coupling 100a and the second coupling 100b a user will simultaneously depress the depressible arms 117a (
As the first coupling 100a and the second coupling 100b are coupled together (i.e., transitioned from the arrangement of
These wiping actions are advantageous for multiple reasons. First, when the first coupling 100a and the second coupling 100b are coupled together no surfaces that are exposed to the ambient ever contact areas that are wetted by a fluid contained in the lumens 119a-b. Accordingly, a sterile connection can be made. The same holds true when the first coupling 100a and the second coupling 100b are uncoupled from each other, i.e., no surfaces that are exposed to the ambient ever contact areas that are wetted by a fluid contained in the lumens 119a-b. Accordingly, a sterile disconnection can be made in some cases, and/or virtually no inclusion (captured ambient air) will be induced into the fluid flow paths of the couplings 100a-b. Moreover, no wetted surfaces are ever exposed to ambient. For these reasons, the first coupling 100a and the second coupling 100b can, under some circumstances, be used in a sterile manner over the course of multiple cycles of connection and disconnection. In some cases, sterile wiping of the portions of the fluid couplings 100a-b may help facilitate use of the fluid couplings 100a-b in a sterile manner over the course of multiple cycles of connection and disconnection.
Moreover, the wiping actions that take place during coupling and uncoupling of the first coupling 100a and the second coupling 100b advantageously prevent fluid spillage when uncoupling and air inclusion when coupling.
While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any invention or of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments of particular inventions. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described herein as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.
Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system modules and components in the embodiments described herein should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single product or packaged into multiple products.
Particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results. As one example, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In certain implementations, multitasking and parallel processing may be advantageous.
This application claims the benefit of U.S. Provisional Application Ser. No. 63/038,321, filed Jun. 12, 2020. The disclosure of the prior application is considered part of (and is incorporated by reference in) the disclosure of this application.
Number | Date | Country | |
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63038321 | Jun 2020 | US |