Aseptic fluid couplings
12480608 ยท 2025-11-25
Assignee
Inventors
Cpc classification
A61M2039/1016
HUMAN NECESSITIES
A61M2039/1066
HUMAN NECESSITIES
A61M39/165
HUMAN NECESSITIES
A61M39/26
HUMAN NECESSITIES
F16L2201/44
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
F16L37/0982
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
F16L37/36
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
A61M39/1011
HUMAN NECESSITIES
International classification
Abstract
Some fluid coupling devices described herein are configured for use in fluid systems for purposes of providing a single-use, aseptic disconnection functionality that substantially prevents fluid spillage when being disconnected. In some embodiments, the coupling portions cannot be functionally reconnected to each other after being disconnected from each other. Some fluid coupling device embodiments described herein include a fluid flow path that is a metallic-free. Moreover, some embodiments of the fluid coupling devices provided herein include no metal whatsoever. That is, the fluid coupling devices are entirely metal-free.
Claims
1. A single-use aseptic fluid coupling assembly defining a longitudinal axis and an open fluid flow path through the single-use aseptic fluid coupling assembly along the longitudinal axis, the single-use aseptic fluid coupling assembly comprising: a first coupling comprising: a first housing; a first termination member fixedly coupled to the first housing and including a first termination; a shell that is rotatably coupled to the first housing; a first valve that is fixedly coupled to the first termination member; and a shuttle disposed about the first valve, the shuttle being coupled to the shell such that the shuttle is translatable along the longitudinal axis in response to rotation of the shell; and a second coupling releasably connected to the first coupling and comprising: a second housing; a second termination member fixedly coupled to the second housing and including a second termination; and a second valve movably coupled to the second termination, the second valve being translatable along the longitudinal axis relative to the second termination, wherein the first housing and the shell comprise a one-way rotation mechanism by which the shell is rotatable relative to the second coupling in only one direction.
2. The single-use aseptic fluid coupling assembly of claim 1, wherein the single-use aseptic fluid coupling assembly is metal-free.
3. The single-use aseptic fluid coupling assembly of claim 1, further comprising a valve gasket compressed between an outer annular face portion of the first valve and an outer annular face portion of the second valve.
4. The single-use aseptic fluid coupling assembly of claim 1, wherein the shell includes one or more projections that are movably disposed in one or more slots defined by the shuttle.
5. The single-use aseptic fluid coupling assembly of claim 1, wherein the one-way rotation mechanism comprises a ratchet and pawl mechanism.
6. The single-use aseptic fluid coupling assembly of claim 1, wherein the shuttle is releasably coupled to the second housing.
7. The single-use aseptic fluid coupling assembly of claim 4, wherein the one or more slots each include: (i) a spirally-extending portion and (ii) a circumferentially-extending portion.
8. The single-use aseptic fluid coupling assembly of claim 1, wherein the first coupling is separable from the second coupling by rotating the shell and then longitudinally separating the first and second couplings from each other.
9. The single-use aseptic fluid coupling assembly of claim 8, wherein the rotating the shell unlatches the first valve from the second valve.
10. The single-use aseptic fluid coupling assembly of claim 8, wherein the rotating the shell uncouples the shuttle from the second housing.
11. The single-use aseptic fluid coupling assembly of claim 8, wherein the first and second couplings cannot be separated from each other until: (i) the first valve is in a closed configuration relative to the shuttle and (ii) the second valve is in a closed configuration relative to the second termination member.
12. The single-use aseptic fluid coupling assembly of claim 11, wherein the rotating the shell moves the first valve to the closed configuration relative to the shuttle and the second valve to the closed configuration relative to the second termination member.
13. A single-use aseptic fluid coupling assembly defining a longitudinal axis and an open fluid flow path through the single-use aseptic fluid coupling assembly along the longitudinal axis, the single-use aseptic fluid coupling assembly comprising: a first coupling comprising: a first housing; and a first valve; and a second coupling releasably connected to the first coupling and comprising: a second housing; and a second valve, the second valve being translatable along the longitudinal axis; and a retainer clip releasably coupled to the first and second couplings and comprising a projection that: (i) passes through an opening defined by the first coupling and (ii) engages with the second coupling, wherein the retainer clip is a flexible C-shaped member that further comprises: (i) a second projection that passes through a second opening defined by the first coupling and engages with the second coupling and (ii) at least two latches spaced from the projection and the second projection that releasably couple with the first coupling, and wherein the first valve is releasably latched to the second valve.
14. The single-use aseptic fluid coupling assembly of claim 13, further comprising a valve gasket compressed between an outer annular face portion of the first valve and an outer annular face portion of the second valve.
15. The single-use aseptic fluid coupling assembly of claim 13, wherein the single-use aseptic fluid coupling assembly is metal-free.
16. The single-use aseptic fluid coupling assembly of claim 13, wherein the first and second couplings cannot be unconnected from each other until both the first valve and the second valve are in a closed configuration.
17. The single-use aseptic fluid coupling assembly of claim 13, wherein the first coupling further comprises a shell that is rotatably coupled to the first housing.
18. The single-use aseptic fluid coupling assembly of claim 17, wherein the shell includes one or more projections that are movably disposed in one or more slots defined by a shuttle.
19. The single-use aseptic fluid coupling assembly of claim 17, wherein the first coupling further comprises a shuttle disposed about the first valve, the shuttle being coupled to the shell such that the shuttle is translatable along the longitudinal axis in response to rotation of the shell.
20. A single-use aseptic fluid coupling assembly defining a longitudinal axis and an open fluid flow path through the single-use aseptic fluid coupling assembly along the longitudinal axis, the single-use aseptic fluid coupling assembly comprising: a first coupling comprising: a first housing; a shell that is rotatably coupled to the first housing, wherein the shell includes one or more projections that are movably disposed in one or more slots defined by a shuttle; and a first valve; and a second coupling releasably connected to the first coupling and comprising: a second housing; and a second valve, the second valve being translatable along the longitudinal axis; and a retainer clip releasably coupled to the first and second couplings and comprising a projection that: (i) passes through an opening defined by the first coupling and (ii) engages with the second coupling, wherein the first valve is releasably latched to the second valve.
21. The single-use aseptic fluid coupling assembly of claim 20, wherein the first coupling further comprises the shuttle disposed about the first valve, the shuttle being coupled to the shell such that the shuttle is translatable along the longitudinal axis in response to rotation of the shell.
22. The single-use aseptic fluid coupling assembly of claim 20, further comprising a valve gasket compressed between an outer annular face portion of the first valve and an outer annular face portion of the second valve.
23. The single-use aseptic fluid coupling assembly of claim 20, wherein the single-use aseptic fluid coupling assembly is metal-free.
24. The single-use aseptic fluid coupling assembly of claim 20, wherein the first and second couplings cannot be unconnected from each other until both the first valve and the second valve are in a closed configuration.
25. A single-use aseptic fluid coupling assembly defining a longitudinal axis and an open fluid flow path through the single-use aseptic fluid coupling assembly along the longitudinal axis, the single-use aseptic fluid coupling assembly comprising: a first coupling comprising: a first housing; a shell that is rotatably coupled to the first housing; a shuttle disposed about the first valve, the shuttle being coupled to the shell such that the shuttle is translatable along the longitudinal axis in response to rotation of the shell; and a first valve; a second coupling releasably connected to the first coupling and comprising: a second housing; and a second valve, the second valve being translatable along the longitudinal axis; and a retainer clip releasably coupled to the first and second couplings and comprising a projection that: (i) passes through an opening defined by the first coupling and (ii) engages with the second coupling, wherein the first valve is releasably latched to the second valve.
26. The single-use aseptic fluid coupling assembly of claim 25, wherein the shell includes one or more projections that are movably disposed in one or more slots defined by the shuttle.
27. The single-use aseptic fluid coupling assembly of claim 25, further comprising a valve gasket compressed between an outer annular face portion of the first valve and an outer annular face portion of the second valve.
28. The single-use aseptic fluid coupling assembly of claim 25, wherein the single-use aseptic fluid coupling assembly is metal-free.
29. The single-use aseptic fluid coupling assembly of claim 25, wherein the first and second couplings cannot be unconnected from each other until both the first valve and the second valve are in a closed configuration.
Description
DESCRIPTION OF THE DRAWINGS
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(29) Like reference numbers represent corresponding parts throughout.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
(30) Referring to
(31) In one non-limiting example, the fluid coupling 100 can provide a single-use, aseptic disconnection capability for a fluid path between the fluid system equipment in the form of a bioreactor system (connected directly to the coupling device 100 or connected via a fluid tube 22) and the fluid system container 30 in the form of a media bag (connected directly to the coupling device 100 or connected via a fluid tube 32).
(32) In the depicted embodiment, the fluid coupling assembly 100 includes a first coupling 200 and a second coupling 300. After the fluid transfer functionality of the fluid coupling assembly 100 has been used, the fluid coupling assembly 100 can be disconnected. That is, a user can disconnect the fluid coupling assembly 100 by separating the first coupling 200 and the second coupling 300 in accordance with a prescribed technique (e.g., see
(33) The first coupling 200 and the second coupling 300 are configured to disconnect from one another in a manner that provides an aseptic disconnection, and that mechanically prevents reconnection and reuse of the fluid flow path 103 through the first coupling 200 and the second coupling 300. As used herein, the term aseptic refers to any process that maintains a sterilized surface or volume. The first coupling 200 and the second coupling 300 are sometimes referred to herein as coupling halves or a coupling-half even though the first coupling 200 and the second coupling 300 are not necessarily equal halves in terms of size, shape, weight, features, or functionality.
(34) In some cases, the fluid coupling assembly 100 is provided to the end user in a sterile condition, or is made to be compatible with sterilization. As used herein, the term sterilize means a process of freeing, to a specified degree, a surface or volume from microorganisms. In example embodiments, the sterility of various components can be achieved using one or more sterilization techniques, including gamma irradiation, E-beam, ethylene oxide (EtO), and/or autoclave technologies. As used herein, the term aseptic refers to any process that maintains a sterilized surface or volume. In some cases, the fluid coupling device 100 is provided to the end user as a component of a system.
(35) Generally, the fluid coupling assembly 100 is provided to an end user in the coupled arrangement, with the coupled mating coupling halves 200 and 300, as depicted in
(36) The first coupling 200 includes a first termination 222. The second coupling 300 includes a second termination 322. While the first and second terminations 222 and 322 are depicted as barbed connections, it should be understood that the coupling halves 200 and 300 can have any type of connections such as, but not limited to, threaded connections (e.g., straight thread or pipe thread), sanitary fittings, compression fittings, aseptic connections, quick connects, quick disconnects, hydraulic connections, luer fittings, solder connections, welded connections, and the like, and combinations thereof. Such connections can be straight (as depicted) or in another arrangement such as, but not limited to, a 90 elbow arrangement, a 45 elbow, a straight fitting, a Tee fitting, a Y-fitting, and so on. In some embodiments, the coupling halves 200 and/or 300 can be configured to be fluidly coupled with a fluid conduit such as, but not limited to, a tube, pipe, a manifold, and the like, without limitation.
(37) The materials from which one or more of the components of the fluid coupling assembly 100 are made of include thermoplastics or thermosets. In particular embodiments, the materials from which the components of the fluid coupling assembly 100 are made of are thermoplastics, such as, but not limited to, acetal, ABS, polycarbonate, polysulfone, polyether ether ketone, polysulphide, polyester, polyvinylidene fluoride (PVDF), polyethylene, Perfluoropolymers (PFA, PTFE, PCTFE and the like), polyphenylsulfone (PPSU; e.g., Radel), polyetherimide (PEI; e.g., Ultem), polypropylene, polyphenylene, polyaryletherketone, Perfluoropolymers (PFA, PTFE, PCTFE and the like) and the like, and combinations thereof. In some embodiments, the thermoplastics can include one or more fillers such as, but not limited to, glass fiber, glass bead, carbon fiber, talc, etc.
(38) In some embodiments, the materials from which one or more of the components of the fluid coupling assembly 100 are made of include metals such as, but not limited to stainless steel, brass, aluminum, plated steel, zinc, and the like. In particular embodiments, one or both of the coupling halves 200 and 300 is/are metallic-free.
(39) In some embodiments, one or both of the coupling halves 200 and/or 300 includes one or more plastic (e.g., PEEK, PPS, etc.) or metallic spring members (e.g., spring steel, stainless steel such as 316 L, piano/music wire, beryllium copper, titanium, Hastelloy, Inconel, and the like).
(40) In certain embodiments, fluid coupling assembly 100 includes one or more gaskets or seals that are made of materials such as, but not limited to, silicone, fluoroelastomers (FKM), ethylene propylene diene monomer (EPDM), perfluoroelastomers (e.g., FFKM, Kalrez, Chemraz and the like), thermoplastic elastomers (TPE), bung, buna-N, thermoplastic vulcanizates (TPV), and the like. In some embodiments, the gaskets or seals can have a cross-sectional shape that is an hourglass-shape, an oval shape, a circular shape, D-shaped, X-shaped, square, rectangular, U-shaped, L-shaped, V-shaped, a polygonal shape, a multi-lobe shape, or any other suitable shape, without limitation.
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(42) The sequence of steps to disconnect the coupling halves 200 and 300 will ensure that the fluid flow paths of the coupling halves 200 and 300 (e.g., the fluid flow path 103 shown in
(43) Referring to
(44) Referring also to
(45) As shown in
(46) The first step of the sequence of steps to disconnect the coupling halves 200 and 300 is disengagement of the latching tabs 252 from the coupling half 300. This is illustrated in
(47) The shell 250 can be considered an anti-tamper sleeve or anti-taper guard because while the latching tabs 252 are engaged with the coupling half 300 no other step for disconnecting the coupling halves 200 and 300 can be performed. Accordingly, the unlatching of the latching tabs 252 from the coupling half 300 must be the first step in the sequence of steps required to disconnect the coupling halves 200 and 300.
(48) The first step in the sequence of steps to disconnect the coupling halves 200 and 300 is completed with the disengagement of the latching tabs 252.
(49) Referring to
(50) Hereinafter, the coupling half 200 can also be referred to as a body 200 or as a first coupling 200, and the coupling half 300 can also be referred to as an insert 300 or as a second coupling 300. The use of the nomenclature of body 200 and insert 300 will also be used to identify some of the components of the body 200 and the insert 300.
(51) As shown, for example, in
(52) The body valve gasket 260 has an annular portion 262 that is seated in a seal groove 234 defined by the body valve 230. The body valve gasket 260 also has a face seal portion 264 that provides a seal between the front face 232 of the body valve 230 and the front face 332 of the insert valve 330. The seal provided by the face seal portion 264 positioned between the front face 232 of the body valve 230 and the front face 332 of the insert valve 330 advantageously contributes to the non-spill performance feature of the fluid coupling assembly 100 by preventing fluid ingress between the body valve 230 and the insert valve 330.
(53) While the fluid coupling assembly 100 is in the operable configuration as shown in
(54) The shuttle 240 is shown in isolation in
(55) The shuttle 240 also defines grooves 242 that include a spirally-extending portion and a circumferentiallyextending portion. The grooves 242 slidably receive corresponding projections 254 (
(56) As the shuttle 240 is being longitudinally translated as a result of the manual rotation of the shell 250, the shuttle 240 longitudinally pulls along with it an insert housing 310 (shown in isolation in
(57) Alternatively, rather than the depicted arrangement in which the insert termination 320 includes a center post 324 on which the insert valve 330 slides, in some embodiments the insert termination 320 includes longitudinally extending ribs and the insert valve 330 includes corresponding grooves. This arrangement is like a double key and keyway arrangement. Other types of cooperating mechanical features between the insert termination 320 and the insert valve 330 by which the insert valve 330 can longitudinally translate relative to the insert termination 320 are also envisioned. For example, in some embodiments the insert termination 320 includes a centrally-located annular ring in which the insert valve 330 slides.
(58) The second step in the sequence of steps to disconnect the coupling halves 200 and 300 is completed with the closure/sealing of the body valve 230 relative to the shuttle 240 and the insert valve 330 relative to the insert termination 320.
(59) After the fluid coupling assembly 100 reaches the closed configuration shown in
(60) The separation of the body valve 230 and the insert valve 330 (as visible in
(61) In another configuration, the cantilevered arms 312 may deflect as a result of contact with ramps on the body housing 210 instead of the body shell 250. In such a case, the longitudinal travel of the shuttle 240 causes the deflection, rather than rotational travel of shell 250.
(62) During this third step in the sequence of steps to disconnect the coupling halves 200 and 300, as the compound ramps 256 exert force on cantilevered arms 312, a sliding O-ring seal between the insert termination 320 and the shuttle 240 is moved longitudinally from an area of high compression (sealed) to an area of low compression (released) within the shuttle 240.
(63) Further rotation of the shell 250 (while the cantilevered arms 312 of the insert housing 310 are disengaged from the shuttle 240) then results in the compound ramps 256 exerting longitudinal forces against the cantilevered arms 312 to force the insert housing 310 to move longitudinally away from the body 200. Referring to
(64) The third step in the sequence of steps to disconnect the coupling halves 200 and 300 is completed with the uncoupling of the insert housing 310 from the shuttle 240, and the longitudinal separation of the front faces 232 and 332 of the body valve 230 and the insert valve 330.
(65) The fourth and final step in the sequence of steps to disconnect the coupling halves 200 and 300 is completed with the manual longitudinal separation of the body 200 from the insert 300 as shown in
(66) The body 200 also includes the body housing 210 (
(67) The saw tooth pattern 212 engages with a pawl 259 (
(68) Moreover, the saw tooth pattern 212 is selectively designed and configured with a specific number of teeth and specific size of teeth so that each increment of rotation of the shell 250 (as determined by an individual tooth of the saw tooth pattern 212) corresponds to a desired distance of translation of the shuttle 240 and/or to a maximum allowable amount of reverse rotation of the shell 250. For example, in some embodiments the maximum allowable amount of reverse rotation of the shell 250 is determined by the width of the sealing surface of a seal 224 (
(69) The body 200 includes the body housing 210, the body termination 220, the body valve 230, the shuttle 240, the shell 250, and the body valve gasket 260. The shell 250 is rotatably coupled to the body housing 210. The body housing 210 is fixedly coupled to the body termination 220. The body valve 230 is fixedly coupled to the body termination 220. The shuttle 240 is disposed about the body valve 230 and movable (longitudinally translatable) relative to the body valve 230 between an open configuration and a closed configuration. The closed configuration is attained by rotating the shell 250, which drives the shuttle 240 to longitudinally from the open configuration to the closed configuration. The shuttle 240 does not rotate as it is being translated.
(70) The insert 300 includes the insert housing 310, the insert termination 320, and the insert valve 330. The insert housing 310 is fixedly coupled to the insert termination 320. The insert valve 330 is movably coupled to the insert termination 320 such that the insert valve 330 is longitudinally translatable relative to the insert termination 320 along the longitudinal axis between an open configuration and a closed configuration.
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(72) In the depicted embodiment of the fluid coupling assembly 100, the first coupling 200 includes a shell 250 and a retainer clip 252. These components are analogs or substitutes for the shell 250 (e.g.,
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(75) In the depicted embodiment, the retainer clip 252 includes two projections 253, each of which has an adjacent latch 255 (for a total of two latches 255). The latches 255 releasably detain the retainer clip 252 on the shell 250 (or on two of the shells 250). The two latches 255 releasably engage with the shell 250 at edge portions that define the cross-shaped openings 251. The projections 253 pass through the cross-shaped openings 251 of the shell 250. After passing through the cross-shaped openings 251, the projections 253 engage with openings defined by the insert housing 310 as described further below.
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(79) 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. 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.