The present disclosure relates to assemblies for retaining and dispensing liquids and, more specifically but not exclusively, to bioprocess bag assemblies, such as (without limitation) those used in medical, laboratory, and cell and gene therapy applications.
This section introduces aspects that may help facilitate a better understanding of the disclosure. Accordingly, the statements of this section are to be read in this light and are not to be understood as admissions about what is prior art or what is not prior art.
Containers (e.g., flexible bags) for fluid containment have been used in numerous applications including bioprocess applications that require a high degree of assurance that (i) contamination will not enter the closed system and (ii) leakage will not occur.
Embodiments of the disclosure will become more fully apparent from the following detailed description, the appended claims, and the accompanying drawings in which like reference numerals identify similar or identical elements.
Detailed illustrative embodiments of the present disclosure are disclosed herein. However, specific structural and functional details disclosed herein are merely representative for purposes of describing example embodiments of the present disclosure. The present disclosure may be embodied in many alternate forms and should not be construed as limited to only the embodiments set forth herein. Further, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments of the disclosure.
As used herein, the singular forms “a,” “an,” and “the,” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It further will be understood that the terms “comprises,” “comprising,” “contains,” “containing,” “includes,” and/or “including,” specify the presence of stated features, steps, or components, but do not preclude the presence or addition of one or more other features, steps, or components. It also should be noted that in some alternative implementations, the functions/acts noted may occur out of the order noted in the figures. For example, two figures shown in succession may in fact be executed substantially concurrently or may sometimes be executed in the reverse order, depending upon the functions/acts involved.
As used herein, the term “port sizer” refers to a type of port fitting that receives a valve connector that supports both (i) a “closed” configuration in which the valve connector is inserted into the port sizer to a “closed position” at which fluid cannot flow through the port sizer and (ii) an “open” configuration in which the valve connector is inserted into the port sizer to an “open position” at which fluid can flow through the port sizer. Another type of port fitting, referred to herein as a “fixed port fitting,” is permanently in an open configuration and is not designed to receive a valve connector.
As known in the art, two pieces of a single-layer or multi-layer flexible plastic, fluoropolymer, or silicone film or some combination are assembled, e.g., by welding, to form the bag chamber 112. A single-port or multi-port, rigid, plastic or fluoropolymer, injection-molded canoe, such as the three-port canoe 114, is then assembled into an unwelded end of the bag chamber 112, e.g., by welding, to form a bag, such as the bag 104. Canoes of the present disclosure may be made of other suitable materials, such as (without limitation) thermoplastic elastomers (TPEs), thermoplastic polyurethane (TPU), or fluoropolymers, and/or manufactured using other suitable techniques, such as (without limitation) 3D printing.
The particular bag assembly 102 of
This provides the user the opportunity to select and customize the internal diameter of the fluid flow and thus the tube size. Those skilled in the art will understand that these sizes are examples and that other suitable sizes are possible.
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Each locking arm 604 has a detent 618 and a rotation stop 620. As shown in
Port sizer 108(3) has two opposing tether tabs 610, which, as described further below, assist in retaining the tethered safety clip 406.
As shown most clearly in
As shown in
Note that the numbers of O-ring grooves in the port sizers 108 and/or in the valve connectors 110 may be different in different embodiments of the present disclosure from those shown in the figures.
As shown in
As shown in the “closed” configuration of
As shown in the “open configuration of
As represented in
Note that the canoe assembly 402 of
To insert a valve connector 110 into a correspondingly sized port sizer 108, the top portion of the valve connector 110 (configured with three O-rings) is inserted into the bottom end of the port sizer 108 with the valve connector keyway guide 718 aligned to engage the port sizer keyway 616, which in turn aligns the valve connector locking tabs 706 and 708 with the port sizer locking clips 606.
When the valve connector 110 is initially inserted into the port sizer 108 to the “closed” configuration, the port sizer locking clips 606 will engage with the valve connector “closed” locking tabs 706. In particular, as the valve connector 110 proceeds along the port sizer channel 614, the port sizer locking clips 606 will pivot outwardly about their locking clip connections 622 as the outer surface of valve connector 110 pushes outwardly on the beveled surfaces of the locking clips 606 until the “closed” configuration is reached, at which point, the beveled upper portions of the locking clips 606 will be received within the beveled valve connector “closed” locking tabs 706, which prevents subsequent removal of the valve connector 110 from the port sizer 108. In this “closed” configuration, the valve connector’s uppermost O-ring is still within the port sizer channel 614 such that fluid flow into and out of the bag 104 through the valve connector 110 is prevented. In addition, in this “closed” configuration, the convex valve connector top surface 716 is flush with the convex canoe top surface 404 (
Note that the port sizer locking clips 606 and the valve connector “closed” locking tabs 706 are designed to prevent the valve connector 110 from being removed from the port sizer 108 after the “closed” configuration has been achieved. In alternative embodiments, the valve connectors and the port sizers may be designed such that the valve connectors are removable from the port sizers.
As described further below, after achieving the “closed” configuration and with the tether clip 410 of the tethered safety clip 406 disengaged from the valve connector 110, the “open” configuration can be achieved by pushing the valve connector 110 further into the port sizer 108 such that the port sizer locking clips 606 will transition from engaging with the valve connector “closed” locking tabs 706 to be engaged with the valve connector “open” locking tabs 708 in a manner analogous to the initial transition to the “closed” configuration. At this “open” configuration, the valve connector stop 710 abuts the port sizer stop 612, thereby preventing the valve connector 110 from being pushed any further into the port sizer 108 in order to prevent leakage.
Note that the port sizer locking clips 606 and the valve connector “open” locking tabs 708 are designed to prevent the valve connector 110 from being removed from the “open” configuration after the “open” configuration has been achieved. In alternative embodiments, the valve connectors and the port sizers may be designed (i) to enable the valve connectors to transition from the “open” configuration back to the “closed” configuration and (ii) possibly to enable the valve connectors to be removable from the port sizers.
To mount a port sizer 108 into a canoe through-hole 504, the top portion of the port sizer 108 (configured with two O-rings) is inserted into the canoe through-hole 504 until the port sizer locking arms 604 abut the bottom surface of the canoe 114 and then the inserted port sizer 108 is rotated clockwise to engage the two port sizer locking arms 604 with the two corresponding canoe retention clips 506 to keep the port sizer 108 in place within the canoe through-hole 504. Note that the port sizer locking arms 604 have rotation stops 620 that stop the clockwise rotation of the port sizer 108 with respect to the canoe 114 to retain the top curvature profile when the rotation stops 620 abut the sides of the canoe retention clips 506. Note further that the locking arms 604 has detents 618 that prevent the mounted port sizer 108 from being removed from the canoe 114. The main functions of the port sizers 108 are to determine the inside diameter of the fluid path and, in some instances, to house the function of the valve connectors 110. The valve connectors allow the operator to open the bag 104 for fluid input and removal.
Referring again to the bag assembly 102 of
When a tube (not shown in
In certain embodiments, the bag chamber 112 may be made of multiple layers of HDPE/EVOH/Nylon or COC – PE/Cyclic Olefin for non-binding. The various other plastic elements may be made of polyethylene (PE), polypropylene (PP), polyvinylidene difluoride (PVDF), or other barrier and breathable layers.
Although port fittings have been described in the context of so-called two-dimensional (2D) bags having canoes, such as bag assembly 100 of
As shown in
The tube retainer system of the present disclosure, which include a threaded tube barb 810 and a threaded tube retainer 1404, can also be applied in fixed tube-to-tube connectors, such as connector 3302 and reducer 3304 shown in the side view of
In this embodiment, the valve connector 3504 can be inserted into the port sizer 3506 and then rotated clockwise to a closed position in which the assembly 3502 is configured in a closed configuration that prevents fluid from flowing through the assembly 3502. The valve connector 3504 can then be further rotated clockwise to an open position in which the assembly 3502 is configured in an open configuration that enables fluid to flow through the assembly 3502. The valve connector 3504 can then be rotated counterclockwise to return the assembly 3502 to the closed configuration. In addition, valve connector 3504 can be further rotated counterclockwise to completely remove the valve connector 3504 from the port sizer 3506. When assembled, the tethered safety clip 406 can be used in a manner analogous to that described previously to prevent the valve connector 3504 from inadvertently advancing from the closed position to the open position.
Note that, in order to enable the valve connector 3504 to rotate inside the port sizer 3506, certain features, such as the locking tabs 706/708 and the keyway guide 718 of the valve connector 110 and the keyway 616 and the locking clip 606 of the port sizer 108, may need to be modified or even removed in the designs of the valve connector 3504 and the port sizer 3506.
Although the disclosure has been described in the context of port sizers (e.g., 108) that receive valve connectors (e.g., 110) having locking mechanisms (e.g., 606, 706, 708) that (i) prevent the valve connector from being removed from the port sizer after the valve connector has reached the closed position and (ii) prevent the valve connector from moving back to the closed position after the valve connector has reached the open position, the disclosure also covers embodiments in which (a) the valve connector can be moved back to the closed position from the open position and/or (b) the valve connect can be removed from the port sizer from the closed position. One possible implementation would involve corresponding threads on the outer diameter of the valve connector and the inner diameter of the port sizer that would allow selective clockwise or counterclockwise rotation of the valve connector with respect to the port sizer to move between closed and open positions. Such an implementation would involve modification and possibly removal of some of the existing features of the port sizer 108 and the valve connector 110, such as the locking mechanisms and keying features.
Although the disclosure has been described in the context of containers (e.g., 102) that receive interchangeable port sizers/fittings (e.g., 108/808), where the port fittings (e.g., 808) or valve connectors (e.g., 110) that are inserted into the port sizers (e.g., 108) have threaded tube barbs (e.g., 810) that receive threaded tube retainers (e.g., 1404), the disclosure also includes containers having permanent ports, where the permanent ports or analogous valve connectors that are inserted into the permanent ports have analogous threaded tube barbs that receive analogous threaded tube retainers.
Bag assemblies of the present disclosure may provide one or more of the following features:
102
104
106
108
110
112
114
402
404
406
408
410
412
414
502
504
506
508
602
604
606
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610
612
614
616
618
620
622
624
626
628
702A
702B
704
706
708
710
712
714
716
718
802
802A
803
804
806
808
810
812
814
816
818
902
904
1002
1004
1006
1008
1102
1104
1106
1108
1202
1204
1206
1208
1210
1302
1402
1404
1802
2002
2004
2006
2008
2202
2204
2206
2208
2302
2304
2502
2504
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2604
2606
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2616
2618
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2802
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2904
3002
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3006
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3106
3202
3204
3302
3304
3306
3308
3310
3312
3314
3402
3404
3502
3504
3506
3508
In certain embodiments of the present disclosure, an assembly comprises a port fitting (e.g., 108/802/808/814/816) for a container (e.g., 104). The port fitting comprises (i) at least one O-ring groove (e.g., 602) at a first end of the port fitting and configured to receive at least one O-ring and (ii) two opposing locking arms (e.g., 604) between the at least one O-ring groove and the second end of the port fitting. The port fitting is configured to be mounted onto the container by (a) inserting the first end of the port fitting into a port (e.g., 504) in the container such that the at least one O-ring forms a seal between the port fitting and the container and (b) rotating the port fitting to engage the two opposing locking arms with two opposing retention clips (e.g., 506) of the container.
In at least some of the above embodiments, each locking arm comprises (1) a rotation stop (e.g., 620) configured to stop the rotation of the port fitting relative to the container at one of the retention clips and (2) a detent (e.g., 618) configured to inhibit removal of the port fitting from the container by rotation.
In at least some of the above embodiments, the first end of the port fitting has a curvilinear shape (e.g., 628) configured to match a curvilinear shape of an interior of the container at the port fitting when the port fitting is mounted onto the container.
In at least some of the above embodiments, the assembly further comprises the container having one or more ports (e.g., 504) and two opposing retention clips (e.g., 506) for each port, each port configured to receive any one of two or more port fittings having differently sized passageways enabling different flow rates.
In at least some of the above embodiments, the container comprises two or more of the ports.
In at least some of the above embodiments, the container is a flexible bag chamber (e.g., 112) permanently connected to a rigid canoe (e.g., 114) having the one or more ports (e.g., 504) and the two opposing retention clips (e.g., 506) for each port.
In at least some of the above embodiments, the canoe has a curvilinear inner surface (e.g., 404) configured to match a curvilinear shape of the interior of the flexible bag chamber at the canoe.
In at least some of the above embodiments, the port fitting is a fixed port fitting (e.g., 802/808/814/816) having (i) a channel (e.g., 614/804) from an open first end of the port fitting to an opposing open second end of the port fitting and (ii) a tube barb (e.g., 806) at the open second end of the port fitting and configured to receive a flexible tube (e.g., 1802) over the tube barb.
In at least some of the above embodiments, the port fitting (e.g., 814/816) has one or more additional open ends.
In at least some of the above embodiments, the port fitting (e.g., 808/814/816) further comprises threading (e.g., 812) between the tube barb and the locking arms, wherein the flexible tube is configured to be secured to the tube barb by (a) feeding the flexible tube through an opening in a threaded tube retainer (e.g., 1404); (b) inserting an end of the flexible tube over the tube barb; and (c) rotating the threaded tube retainer onto the port fitting’s threading.
In at least some of the above embodiments, the assembly further comprises the threaded tube retainer.
In at least some of the above embodiments, the port fitting further comprises a port fitting stop (e.g., 612) between the threading and the locking arms, wherein the port fitting stop is configured to stop the rotation of the threaded tube retainer.
In at least some of the above embodiments, the port fitting stop comprises at least one retainer locking tab (e.g., 818) configured to engage at least one anti-rotation feature (e.g., 2206) of the threaded tube retainer to lock the threaded tube retainer in place onto the port fitting.
In at least some of the above embodiments, the assembly further comprises a valve connector (e.g., 110/1102/1104/1106/3504) comprising (1) a closed first end; (2) a channel (e.g., 714) from (i) at least one side port (e.g., 704) near the closed first end of the valve connector to (ii) an opposing open second end of the valve connector; (3) at least one upper O-ring groove (e.g., 702A) between (i) the closed first end of the valve connector and (ii) the at least one side port and configured to receive at least one upper O-ring; (4) at least one lower O-ring groove (e.g., 702B) between (i) the at least one side port and (ii) the open second end of the valve connector and configured to receive at least one lower O-ring; and (5) a tube barb (e.g., 712) at the open second end of the valve connector and configured to receive a flexible tube (e.g., 1802) over the tube barb. The valve connector is configured to be mounted onto the port fitting into a closed configuration by inserting the closed first end of the valve connector into the second end of the port fitting to a closed position such that the upper and lower O-rings form seals between the valve connector and the port fitting. The valve connector is configured to be moved from the closed configuration to an open configuration by further inserting the valve connector into the port fitting to an open position in which the at least one side port of the valve connector is open to the interior of the container to connect the interior of the container to the channel through the valve connector with the at least one lower O-ring forming at least one seal between the valve connector and the port fitting.
In at least some of the above embodiments, the valve connector (e.g., 1102/1104/1106) has one or more additional open ends.
In at least some of the above embodiments, the closed first end of the valve connector has a curvilinear shape (e.g., 716) configured to match a curvilinear shape of an interior of the container at the valve connector when (i) the port fitting is mounted onto the container and (ii) the valve connector is inserted into the port fitting up to the closed position.
In at least some of the above embodiments, the port fitting comprises a port fitting stop (e.g., 612) at the second end of the port fitting, and the valve connector comprises a valve connector stop (e.g., 710) between the at least one lower O-ring groove and the tube barb, wherein the valve connector stop and the port fitting stop are configured to stop the insertion of the valve connector into the port fitting at the open position.
In at least some of the above embodiments, the assembly further comprises a tethered safety clip (e.g., 406) configured to be removably positioned between the valve connector stop and the port fitting stop to prevent the valve connector from moving from the closed position to the open position.
In at least some of the above embodiments, the valve connector further comprises threading (e.g., 1402) between the tube barb and the valve connector stop, wherein the flexible tube is configured to be secured to the tube barb by (a) feeding the flexible tube through an opening in a threaded tube retainer (e.g., 1404); (b) inserting an end of the flexible tube over the tube barb; and (c) rotating the threaded tube retainer onto the port fitting’s threading, wherein the valve connector stop is configured to stop the rotation of the threaded tube retainer.
In at least some of the above embodiments, the assembly further comprises the threaded tube retainer.
In at least some of the above embodiments, the valve connector stop comprises at least one retainer locking tab (e.g., 818) configured to engage at least one anti-rotation feature (e.g., 2206) of the threaded tube retainer to lock the threaded tube retainer in place onto the valve connector.
In at least some of the above embodiments, the port fitting comprises (i) at least one locking clip (e.g., 606) located between the locking arms and the second end of the port fitting and (ii) at least one keyway (e.g., 618) located between the at least one locking clip and the second end of the port fitting, and the valve connector comprises (i) at least one closed locking tab (e.g., 706) located between the at least one lower O-ring groove and the tube barb; (ii) at least one open locking tab (e.g., 708) located between the at least one closed locking tab and the tube barb; and (iii) at least one keyway guide (e.g., 718) located between the at least one open locking tab and the tube barb. The at least one keyway is configured to receive the at least keyway guide to ensure proper rotational orientation when the valve connector is inserted into the port fitting; the at least one locking clip is configured to receive the at least one closed locking tab at the closed position and inhibit removal of the valve connector from the port fitting; and the at least one locking clip is configured to receive the at least one open locking tab at the open position and inhibit moving the valve connector from the open position to the closed position.
In at least some of the above embodiments, the valve connector (e.g., 3504) is movable from the open position back to the closed portion within the port fitting (e.g., 3506) to reconfigure the assembly from the open configuration back to the closed configuration.
In certain embodiments of the present disclosure, an assembly comprises a connector (e.g., 110/808) and a threaded tube retainer (e.g., 1404). The connector comprises a first end; an open second end; a tube barb (e.g., 712/806) at the open second end and configured to receive a flexible tube (e.g., 1802) over the tube barb; threading (e.g., 812/1402) between the first end and the tube barb; and a connector stop (e.g., 710/612) between the first end and the threading. The flexible tube is configured to be secured to the tube barb by feeding the flexible tube through an opening in the threaded tube retainer; inserting an end of the flexible tube over the tube barb; and rotating the threaded tube retainer onto the connectors threading, wherein the connector stop is configured to stop the rotation of the threaded tube retainer.
In at least some of the above embodiments, the connector stop comprises at least one retainer locking tab (e.g., 818) configured to engage at least one anti-rotation feature (e.g., 2206) of the threaded tube retainer to lock the threaded tube retainer in place onto the valve connector.
In at least some of the above embodiments, the threaded tube retainer comprises an inner smooth frustum portion (e.g., 2204) adjacent to the threaded tube retainer’s threading and configured to form seals between (i) the tube barb and an inner surface of the flexible tube and between (ii) an outer surface of the flexible tube and the threaded tube retainer.
In at least some of the above embodiments, the threaded tube retainer comprises to opposing wings (e.g., 2208) providing leverage for rotating the threaded tube retainer onto the connector’s threading.
In at least some of the above embodiments, the connector is a valve connector (e.g., 110).
In at least some of the above embodiments, the connector is a fixed port fitting (e.g., 808).
In at least some of the above embodiments, the connector is tube-to-tube connector (e.g.,3302-3306, 3312).
While this disclosure includes references to illustrative embodiments, this specification is not intended to be construed in a limiting sense. Various modifications of the described embodiments, as well as other embodiments within the scope of the disclosure, which are apparent to persons skilled in the art to which the disclosure pertains are deemed to lie within the principle and scope of the disclosure, e.g., as expressed in the following claims.
Unless explicitly stated otherwise, each numerical value and range should be interpreted as being approximate as if the word “about” or “approximately” preceded the value or range.
It will be further understood that various changes in the details, materials, and arrangements of the parts which have been described and illustrated in order to explain the nature of this disclosure may be made by those skilled in the art without departing from the scope of the disclosure, e.g., as expressed in the following claims.
Reference herein to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the disclosure. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. The same applies to the term “implementation.”
Unless otherwise specified herein, the use of the ordinal adjectives “first,” “second,” “third,” etc., to refer to an object of a plurality of like objects merely indicates that different instances of such like objects are being referred to, and is not intended to imply that the like objects so referred-to have to be in a corresponding order or sequence, either temporally, spatially, in ranking, or in any other manner.
Also for purposes of this description, the terms “couple,” “coupling,” “coupled,” “connect,” “connecting,” or “connected” refer to any manner known in the art or later developed in which energy is allowed to be transferred between two or more elements, and the interposition of one or more additional elements is contemplated, although not required. Conversely, the terms “directly coupled,” “directly connected,” etc., imply the absence of such additional elements. The same type of distinction applies to the use of terms “attached” and “directly attached,” as applied to a description of a physical structure. For example, a relatively thin layer of adhesive or other suitable binder can be used to implement such “direct attachment” of the two corresponding components in such physical structure.
The described embodiments are to be considered in all respects as only illustrative and not restrictive. In particular, the scope of the disclosure is indicated by the appended claims rather than by the description and figures herein. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.
In this specification including any claims, the term “each” may be used to refer to one or more specified characteristics of a plurality of previously recited elements or steps. When used with the open-ended term “comprising,” the recitation of the term “each” does not exclude additional, unrecited elements or steps. Thus, it will be understood that an apparatus may have additional, unrecited elements and a method may have additional, unrecited steps, where the additional, unrecited elements or steps do not have the one or more specified characteristics.
The use of figure numbers and/or figure reference labels in the claims is intended to identify one or more possible embodiments of the claimed subject matter in order to facilitate the interpretation of the claims. Such use is not to be construed as necessarily limiting the scope of those claims to the embodiments shown in the corresponding figures.
All documents mentioned herein are hereby incorporated by reference in their entirety or alternatively to provide the disclosure for which they were specifically relied upon.
The embodiments covered by the claims in this application are limited to embodiments that (1) are enabled by this specification and (2) correspond to statutory subject matter. Non-enabled embodiments and embodiments that correspond to non-statutory subject matter are explicitly disclaimed even if they fall within the scope of the claims.
While preferred embodiments of the disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that various alternatives to the embodiments of the disclosure described herein may be employed in practicing the technology of the disclosure. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
This application claims the benefit of the filing date of U.S. provisional application no. 63/323,150, filed on 3/24/22 as attorney docket no. 1405.001 PROV, the teachings of which are incorporated herein by reference in their entirety.
Number | Date | Country | |
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63323150 | Mar 2022 | US |