Two-component plug assembly for a spout
A two-piece plug assembly with a flow restrictor is used to address leakage issues in aseptic pouches by allowing pre-filling positioning and post-filling secure engagement, ensuring leak-proof operation and safe discharge.
Patent Information
- Application Number
- JP2025502860
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-07-21
- Filing Date
- 2023-07-21
- Publication Date
- 2025-07-30
AI Technical Summary
Existing aseptic pouch technologies face challenges in preventing leakage when the pouch is inverted or compressed, especially during the filling process, as incorporating a flow restrictor into the spout complicates filling operations.
A two-piece plug assembly is introduced, comprising a plug and a plug insert with a flow restrictor, which is positioned in a pre-filling state, allowing for filling without being fixed, then repositioned post-filling to securely engage with the spout, ensuring the flow restrictor remains in place to prevent leakage.
The solution effectively prevents leakage during inversion or compression by maintaining the flow restrictor within the spout, allowing safe discharge of the contents only when sufficient force is applied, thus ensuring a sterile and leak-proof operation.
Smart Images
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Abstract
Description
Technical Field
[0001] Cross - reference to Related Applications This application claims the benefit of the filing dates of U.S. Provisional Patent Application No. 63 / 391,102, filed on July 21, 2022, and U.S. Provisional Patent Application No. 63 / 395,612, filed on August 5, 2022, the disclosures of which are hereby incorporated by reference in their entireties.
[0002] This disclosure relates to a dispensing device for a container.
Background Art
[0003] Aseptic pouch technology that discloses a removable plug for aseptic filling is known in the art. U.S. Pat. Nos. 9,751,677, 10,035,614, and 10,370,165, which are hereby incorporated by reference in their entireties, generally relate to aseptic plug technology, where the plug is placed on the pouch and sterilized before aseptic filling with an aseptic filling machine. In the methods described in U.S. Pat. Nos. 9,751,677, 10,035,614, and 10,370,165, the plug is removed in a sterile environment before filling and re - positioned in a sterile environment after filling. Thereafter, a cap is placed on the plug. U.S. Pat. No. 10,829,286 and U.S. Patent Application No. 11,167,903, which are hereby incorporated by reference in their entireties, disclose cap structures and capping methods. U.S. Pat. No. 9,751,677 relates to the plug, and U.S. Pat. No. 10,035,614 relates to a method of filling an aseptic pouch. Both U.S. Pat. Nos. 9,751,677 and 10,035,614 are hereby incorporated by reference in their entireties. U.S. Pat. No. 10,370,165 relates to a closure structure including a plug and a cap, which is hereby incorporated by reference in its entirety.
[0004] For certain applications, it is necessary to prevent leakage from the pouch even when the pouch is inverted and the cap and plug are removed. Leakage can be prevented by incorporating a flow restrictor such as a valve or baffle into the spout or fitting. However, incorporating a flow restrictor into the spout can present challenges during filling, such as the need to fill through the flow restrictor.
SUMMARY OF THE INVENTION
[0005] The present disclosure solves these problems by introducing a two-piece plug assembly that includes a flow restrictor for a drip-preventing spout for a particularly low-acid sterile container that can be removed within a sterile zone prior to filling. The two-piece plug can be used in combination with the filling of a flexible container such as a sterile pouch. The steps of the filling process can include providing a pouch having a fitting with a spout, and the two-piece plug assembly can be sealingly engaged with the spout. Prior to filling the pouch, the plug assembly can be positioned in a pre-filling position partially pushed along the spout, thereby blocking access to the interior of the pouch, but the plug assembly is not yet fixed or locked to the spout. During filling, the plug assembly is removed and the pouch can be filled using a filling tube within a sterile filling machine. After filling, the plug assembly is repositioned, but the plug assembly is fixedly engaged with the spout at a position closer to the flexible container.
[0006] The two-piece plug assembly fixedly engages the spout using only one of the two parts. The two parts of the plug assembly are a plug and a plug insert. The plug forms the outer and upper part of the plug assembly, and the plug insert can be located inside the plug. The plug insert may include tabs and recesses for fixedly engaging the spout, and may also include a flow restrictor such as a valve or baffle. The flow restrictor may be designed to prevent leakage of a liquid or semi-liquid product contained in the flexible container before it is used by the consumer.
[0007] When discharging the product, the plug may first be removed. Since the plug insert is fixedly engaged with the spout, the plug insert and the flow restrictor may remain in the spout. By the plug insert and the associated flow restrictor remaining in the spout, leakage of the fluid substance in the pouch from the spout can be prevented when the container is inverted. In the present disclosure, the product can be discharged only when the pouch is squeezed with sufficient force.
Brief Description of the Drawings
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DETAILED DESCRIPTION OF THE INVENTION
[0009] 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 invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice of the present invention, the preferred methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. Further, it will be understood that the drawings are only schematic representations of the invention and that some components may be distorted from actual scale for visual clarity.
[0010] Details of one or more embodiments of the invention are described in the accompanying drawings and in the following description. Other features, objects, and advantages of the invention will become apparent from the description and drawings, and from the claims. All joints including friction fits can be adjusted by optimization to provide the intended results contemplated within the scope of this disclosure.
[0011] Reference is now made to the drawings. FIGS. 1 and 3 show plug 100 and plug assembly 300. Plug assembly 300 can be configured for use with a sterile pouch filler. The sterile filling assembly is configured to fill a pouch within a sterile environment and a sterile zone. The sterile zone includes a zone through which a sterilizing gas flows at a positive pressure. As sterile standards, the standards described in Title 21 of the Code of Federal Regulations by the U.S. Food and Drug Administration for heat-treated low-acid foods packaged in sealed containers, and standards such as those of 3-A Sanitary Standards, Inc., and the European Hygienic Engineering and Design Group (EHEDG) may be complied with.
[0012] Prior to filling, flexible container 1100 (shown in FIG. 36) can be pre-sterilized, for example, by gamma rays, X-rays, electron beams, or other sterilization processes before being introduced into the filling equipment, such that the internal cavity of flexible container 1100 is a pathogen-free sterile environment. The plug can be sealed, thereby maintaining a sterile environment throughout flexible container 1100 and within spout 400. Flexible container 1100 can include a metal or metallized layer in some embodiments and can be composed of a multilayer polymer structure that can be co-extruded and laminated.
[0013] FIG. 1 shows plug 100 attached to spout 400 of fixture 150. Fixture 150 may be in fluid communication with a container, which may be a flexible container 1100 such as a pouch for a fluid substance 600 (shown in FIG. 25). Fluid substance 600 may be a liquid or semi-solid substance. When a force is applied to flexible container 1100, fluid substance 600 can be discharged from spout 400.
[0014] A and B in FIG. 2 show cross-sectional views of two molded parts, plug 100 and plug-in insert 200. The components of the present disclosure may be composed of plastic, elastomer, or other materials recognized by those skilled in the art as suitable. The components of the present disclosure may be manufactured by molding, machining, or other methods, as is well known to those skilled in the art. Plug 100 and plug-in insert 200 are, in some embodiments, generally cylindrical with an annular cavity and may have a central axis.
[0015] Regarding A in FIG. 2, in one embodiment, the structure of the plug 100 may include an outer plug wall 102 having an inner surface, an outer surface, an upper end, and a lower end, and the inner surface defines a cavity. The outer plug wall 102 may have plug threads 108 on the inner surface and may have a knurled portion 110 on a part of the outer surface to facilitate removal of the threads of the plug 100 and provide a surface that is easy to grip. The easy-to-grip surface may be a non-uniform surface, or a rough surface, or other types of surfaces that those skilled in the art recognize as facilitating gripping. The material of the easy-to-grip surface may be rubber, plastic, silicon, etc. The plug threads 108 may be continuous or substantially continuous, and various types of threads known to those skilled in the art of screw closures may be used. The plug 100 may also include an upper plug wall 104, and the inner plug wall 106 extends longitudinally from the upper plug wall 104 in a direction approaching the flexible container 1100. The inner plug wall 106 may have an inner surface, an outer surface, an upper end, and a lower end, and the inner surface defines an internal cavity. The outer plug wall 102 may be connected to a tamper-evident break band 114 by a series of thin strips 112 in one embodiment. The tamper-evident break band 114 may include an inner chamfer 118 and an outer chamfer 116 on its inner and outer surfaces, respectively, to assist in connecting the outer plug wall 102 to the spout 400. The spout 400 and the fixture 150 may be molded from a polymer such as polyethylene, or other plastics, etc. The specific material forming the spout is disclosed only for illustrative purposes and is not considered limiting. In some embodiments, when the plug insert 200 is inserted into the plug 100 (shown in FIG. 3), for the purpose of engaging with a flow restrictor 250 (shown in B of FIG. 2) to prevent leakage of the fluid substance 600, the plug shaft 122 may extend downward from the upper plug wall 104.
[0016] B in FIG. 2 shows a plug insert 200 that can be inserted into the plug 100. The plug insert 200 may include a central plug insert portion 202, a distal plug insert portion 204, and a proximal plug insert portion 218. The proximal plug insert portion 218 is the portion of the plug insert 200 that is closest to the flexible container 1100 when the plug assembly 300 is disposed in the spout 400. The proximal plug insert portion 218 may include a plug insert recess 206, a plug insert tab 216, and a flow restrictor 250. The plug insert recess 206 may be discontinuously present around the plug insert 200 in some embodiments, and may be continuous in some embodiments.
[0017] The plug insert body 220 may include all elements of the plug insert 200 except the flow restrictor 250. In some embodiments, the flow restrictor 250 may be a baffle or valve having a hinge structure or capable of being hinged. The flow restrictor 250 may be made of plastic, elastomer, metal, composite material, or other materials recognized by those skilled in the art as appropriate. For example, when the flow restrictor 250 is a baffle as shown in FIG. 9, a more rigid material may be preferred in some cases. When the flow restrictor 250 is a valve as in one embodiment shown in FIGS. 10 - 11, a more flexible material may be preferred in some cases.
[0018] In some embodiments, the flow restrictor 250 may be connected to the proximal plug insert portion 218 by a hinge 210 having a narrow gap located between the flow restrictor 250 and the proximal plug insert portion 218. The hinge 210 may be a living hinge recognized by those skilled in the art, such as a straight or flat living hinge, a butterfly living hinge, a double or triple living hinge. The living hinge may be manufactured by methods recognized by those skilled in the art, such as subtractive machining, injection molding, 3D printing, rubber molding. Other suitable types of hinges recognized by those skilled in the art may also be used.
[0019] In some embodiments, the flow restrictor 250 may be a valve made of flexible plastic, silicon, silicone rubber, or a silicone-based material, and may be a star valve or an Aptar® SimpliSqueeze® type self-sealing valve that can be used in a condiment bottle. Such valves are well known to those skilled in the art as those used in condiment bottles and household cleaning bottles. Embodiments of such valves are shown in FIGS. 13 and 14 of U.S. Patent No. 5,213,236, described throughout the patent, and incorporated herein by reference in its entirety.
[0020] FIG. 3 shows a cross-sectional view of a plug assembly 300 formed by assembling the plug 100 and the plug insert 200. The outer diameter of the distal plug insert portion 204, which may have a diameter smaller than that of the central plug insert portion 202, and the inner diameter of the inner plug wall 106 may be designed to be sized such that the two parts can slide and combine or separate with minimal force, forming a dimensional fit known to those skilled in the art as a friction fit. In some embodiments, the friction fit may be sufficient to maintain a sterile or aseptic environment within the flexible container 1100.
[0021] In some embodiments, the plug 100 may or may not be threaded. In some embodiments, the plug 100 and the plug assembly 300 may be connected to the spout 400 by a threaded mechanism or by a friction fit. The plug 100 may be composed of a flexible, elastomeric, rigid, or semi-rigid material. In some embodiments, the plug 100 may have a dual function as a cap and a plug. In some embodiments, the plug 100 may have an outer surface adapted for gripping by a human hand.
[0022] FIG. 4 shows a cross-sectional view of a spout 400 including a spout neck 402, a spout screw 412, and a spout body 404. The lower end (not shown) of the spout body 404 is preferably designed to be in fluid communication with a pouch or other flexible container 1100 for the fluid substance 600. The flexible container 1100 may be filled by an automatic filling device and discharged by an end user such as a consumer. The spout body 404 may include, in some embodiments, a plurality of extension arms 408a and 408b and a plurality of arm tabs 410a and 410b designed to function as a tamper-evidence mechanism, as will be described in more detail below. At least one internal spout tab 414 can secure the plug insert 200 to the spout 400 after the flexible container 1100 is filled, as shown in FIG. 6. In some embodiments, the internal spout tab 414 may be located approximately above, near, or distal to the parting line of the mold.
[0023] FIG. 5 is a cross-sectional view of a plug assembly 300 disposed on a spout 400 after the spout 400 and the flexible container 1100 have been sterilized in some embodiments. As is apparent from the presence of a gap 302 between the inner spout tab 414 and the plug insert 200 when the plug assembly 300 is disposed on the spout 400 prior to filling, the plug screw 108 is not fully engaged with the spout screw 412. The plug insert tab 216 is in the pre-fill position of the plug assembly 300 and is disposed distal to the inner spout tab 414. Due to this limited engagement, when the plug assembly 300 is disposed on the spout 400 prior to filling, the tamper-evident break band 114 is not fixed by the arm tab 410, or the inner spout tab 414 does not enter the plug insert recess 206 to fixedly engage the plug insert tab 216, so that the plug insert 200 is not fixed within the spout 400. The plug insert tab 216 is generally defined as a feature adapted to be located adjacent to, below, or proximal to the plug insert recess 206 for the purposes of the present disclosure and fixedly engage the inner spout tab 414 to hold the plug insert 200 in place, and may not be limited by a particular structure. The contact between the plug assembly 300 and the spout 400 may be sufficient to form a seal that maintains the sterility of the plug assembly 300 to avoid contamination prior to filling the flexible container 1100. In some embodiments of the present disclosure, this seal meets the sterility processing criteria defined by the U.S. Food and Drug Administration (FDA) at the time of filing of the present disclosure.
[0024] FIG. 6 is a cross-sectional view of the plug assembly 300 inserted into the spout 400 after filling the flexible container 1100. Before filling, the plug assembly 300 can be placed in a sterile environment and the plug assembly 300 can be removed for filling. Next, a fluid substance 600 (shown in FIG. 25) can be injected into the flexible container 1100 through the spout neck 402. Thereafter, upon placement of the filled plug assembly 300, the plug assembly 300 can be repositioned and fully engaged with the spout thread 412. Complete engagement can include the plug-in insert tab 216 fixedly engaging with the inner spout tab 414, and the inner spout tab 414 is disposed within the plug-in insert recess 206. In some embodiments, complete engagement between the plug assembly 300 and the spout 400 can securely fix the tamper-evident break band 114 by the arm tab 410, and the inner spout tab 414 can be securely fixed within the plug-in insert recess 206 by fixedly engaging with the plug-in insert tab 216. The depth of the inner spout tab 414 can be minimized such that when placing the filling tube 1050 through the spout 400 during filling, they do not protrude significantly into the spout cavity and substantially interfere. On the other hand, the depth of the inner spout tab 414 can be large enough to fixedly engage with the plug-in insert tab 216 and hold the plug-in insert 200 within the spout before discharging the fluid substance 600. The optimal depth of the inner spout tab 414 can vary, but can be determined through ordinary optimization techniques as recognized by those skilled in the art.
[0025] The engaging means of the plug insert 200 and the spout 400 are illustratively shown in FIG. 6 to include the plug insert tab 216 and the internal spout tab 414, but this is not intended to be limiting. Any suitable means of fixed engagement, including connection means such as male-female (plug, pin, protrusion, receptacle, socket, slot), genderless, mechanical, magnetic, friction fit, modular, and other attachment or connection means recognized by those skilled in the art, are within the scope of the present disclosure. FIG. 6 shows the general configuration of the plug assembly 300 and the spout 400 when the device is ready for use by the consumer.
[0026] As shown in FIGS. 6, 7A, and 7B, in some embodiments, the plug shaft 122 may be adapted to engage the flow restrictor 250. The plug shaft 122 may serve to prevent inadvertent opening of the flow restrictor 250 during shipping, handling, or transportation. The plug shaft 122 may be integral with the upper plug wall 104 and engage the flow restrictor 250 within the plug assembly 300 to prevent inadvertent outflow through the flow restrictor 250. Since the plug shaft 122 is in proximity to the flow restrictor 250, it may forcibly prevent inadvertent opening of the flow restrictor 250. When the plug 100 is separated from the plug insert 200 by the end user, the plug shaft 122 may be removed from its position within the plug assembly 300, and by applying force to the flexible container 1100 by the user, the fluid substance 600 may be discharged through the flow restrictor 250.
[0027] A of FIG. 7 shows a cross-sectional view of a plug-in insert assembly 500 including a spout 400 after the plug 100 is removed, indicating a state where the plug-in insert 200 is held in a predetermined position by the internal spout tab 414 fixedly engaging with the plug-in insert tab 216. Also shown in A of FIG. 7 is a tamper-evident break band 114 fixed in a predetermined position by an arm tab 410. Regarding the tamper-evident feature, in some embodiments, when the user rotates the plug 100, a thin strip 112 breaks, thereby providing evidence that the plug 100 has not been removed previously. B of FIG. 7 shows the plug 100 after the tamper-evident break band 114 is separated and the plug 100 is removed from the spout 400, thereby enabling the discharge of the fluid substance 600.
[0028] After the flexible container 1100 is filled and the plug assembly 300 is repositioned to the post-filling position, the flexible container 1100 may be stored or placed with the spout 400 facing downward, and the flow restrictor 250 may prevent leakage of the fluid substance 600. In some embodiments, leakage may be prevented by capillary forces generated by a narrow gap between the flow restrictor 250, which may be a baffle as shown in FIG. 9, and the cylindrical inner surface of the plug-in insert 200. In some embodiments, the hinge 210 shown in B of FIG. 2 may bend when a predetermined internal pressure is applied to the flexible container 1100, and the fluid substance 600 is discharged from the plug-in insert 200. In some embodiments, the flow restrictor 250 may have a wedge portion 450 as shown in A of FIG. 7, and the wedge portion 450 may be rigid or flexible in some embodiments and opens when pressure is applied to the flexible container 1100. Other shapes and designs of the flow restrictor 250, including the solid circular shape of the baffle, are contemplated within the scope of the present disclosure.
[0029] FIG. 8 shows an embodiment of the present disclosure that includes features to prevent deformation of the plug insert 200. In some embodiments, it may be desirable to prevent deformation of the plug insert 200 during insertion to maintain the proper position of the flow restrictor 250. When inserting the plug insert 200 into its final position, a radial force can occur on the plug insert 200 when the plug insert tab 216 passes through the inner spout tab 414 and seats in the post-fill position. The compression support lip 802 may have an inclined surface that is disposed along the lower diagonal edge of the flow restrictor 250 that is above the compression support lip 802. With this configuration, when a radial force is applied to the plug insert 200 when inserting the plug assembly 300 into the spout 400, an upward force into the plug shaft 122 is imparted to the flow restrictor 250. The application of the radial force can prevent displacement of the flow restrictor 250 by the plug shaft 122, thereby preventing leakage of the fluidic material 600 and malfunction of the flow restrictor 250. The compression recess 806 can reduce the pressure applied to the flow restrictor 250 by the plug shaft 122 by allowing the end of the flow restrictor 250 to slide up onto the inner surface of the plug insert 200 during insertion into the spout 400 because the flow restrictor 250 may flex slightly around the plug shaft 122 during compression of the plug insert 200. The end of the flow restrictor 250 may be angled in some embodiments to slidably engage the compression recess 806. In some embodiments, the plug insert tab 216 may extend further into the spout 400 at an angle such that a substantially straight line is formed from the compression support lip 802 of the plug insert tab 216 to the inner surface of the spout body 404 in a direction opposite to the compression support lip 802.
[0030] An alternative approach to preventing compression of the plug insert 200 and displacement of the flow restrictor 250 may include positioning the flow restrictor 250 at a sufficient distance from the plug insert recess 206 to avoid deformation of the flow restrictor 250 when the plug assembly 300 is inserted into the spout 400. Alternatively, by shaping the inner spout tab 414 or the plug insert tab 216 in a fishhook shape to provide flexibility, deformation or displacement of the flow restrictor 250 can be reduced. In some embodiments, using a less rigid material for the plug 100 and the spout 400 can also reduce deformation or displacement of the flow restrictor 250. On the other hand, using a more rigid material for the plug insert 200 compared to the material of the spout 400 can suppress or reduce deformation and misalignment of the plug insert 200.
[0031] FIG. 9 is a top perspective view of a sterile plug insert 200 including a flow restrictor 250, and the flow restrictor 250 may have a hinge structure (as shown in B of FIG. 2) or may be hingeable. The flow restrictor 250 shown in FIG. 9 is shown as having a solid or plate shape, and in some embodiments, the plug insert body 220 may be composed of a rigid plastic or other rigid material. Also, the flow restrictor 250 shown in FIG. 10 may be composed of a rigid material such as rigid plastic and may be a one-way hinge type baffle. In some embodiments, the flow restrictor 250 may not have a hinge structure. In one embodiment, FIG. 10 shows a plug insert, the plug insert body 220 may be composed of a hard material such as plastic, and the flow restrictor 250 may be composed of an elastomeric material or a flexible material.
[0032] FIG. 10 is a top perspective view of the sterile plug insert 200, showing a flow restrictor 250 having a star or wedge shape. In some embodiments, the plug insert body 220 may be composed of a rigid plastic or other rigid material, and the flow restrictor 250 may be composed of a flexible material such as silicon, silicone rubber, rubber, or an elastomer having functionality similar to that of a silicon or silicon-based material. Alternatively, in some embodiments, the flow restrictor 250 shown in FIG. 10 may be composed of a rigid material such as a rigid plastic and may be a one-way hinge-type baffle.
[0033] FIG. 11 is a top perspective view of the sterile plug insert 200, and both the plug insert body 220 and the flow restrictor 250 may be molded from a flexible material such as silicon, silicone rubber, rubber, or an elastomer having functionality similar to that of a silicon or silicon-based material. In one embodiment, FIG. 11 shows a flexible plug insert 200, and the plug insert body 220 and the flow restrictor 250 may be composed of an elastomer.
[0034] FIGS. 12 and 13A - C show a plug 100 having a generally cylindrical interior and exterior, and the inner plug wall 106 may be dimensioned to frictionally engage the plug insert 200. The outer plug wall 102 may be dimensioned to form a seal that closely adheres to the spout 400 and the fixture 150. As shown in FIG. 12, in some embodiments, the plug 100 may include two sets of recesses: a short recess 1006 whose distal end terminates at a short recess stopper 1008 and a long recess 1010 whose distal end terminates at a long recess stopper 1012. These will be described in further detail below.
[0035] A - C of FIG. 13 show embodiments of a plug assembly 300 that is attached to a spout 400 of a fixture 150 by friction fit rather than by a screw mechanism. In one aspect, this embodiment of the plug 100 of the present disclosure may be a modification of the plug shown and described in U.S. Patent No. 9,751,677, and in the present disclosure, the plug may be modified to include a plug insert 200. Elements of the present disclosure that may be equivalent to specific elements of U.S. Patent No. 9,751,677 may have the same or different names in the present disclosure. However, differences or similarities in names between the present disclosure and U.S. Patent No. 9,751,677 are not intended to be limiting, nor are they necessarily intended to indicate similarities or differences in structure or function.
[0036] In some embodiments of the present disclosure, the plug 100 may include an upper plug wall 104, an inner plug wall 106, and an outer plug wall 102. The outer plug wall 102 may depend from the upper plug wall 104 in a direction opposite to the upper plug wall 104. The outer plug wall 102 may be axially spaced from the inner plug wall 106. The plug 100 may be attachable to the spout 400. In some embodiments, the inner plug wall 106 may extend into the spout 400 and may provide a seal between the inner plug wall 106 and the spout 400 and between the inner plug wall 106 and the distal plug insert portion 204.
[0037] FIG. 14 shows a plug 100 having a disk portion 1002 at the top of the plug 100 for grasping and lifting the plug 100. The disk portion 1002 may be integral with the top of the plug 100, and the rectangular portion 1004 between the disk portion 1002 and the plug upper wall 104 may facilitate positioning the plug 100 at an accurate angle relative to the fixture 150 during the filling process. Mechanisms for capping, grasping, and lifting the plug 100 are described in U.S. Patent No. 10,829,286 and U.S. Patent No. 11,167,903, which are hereby incorporated by reference in their entireties.
[0038] A and B of FIG. 15 show the flow restrictor 250 at the most proximal position within the plug-in insert 200 relative to the flexible container 1100. The flow restrictor 250 can be disposed at any position along the axis of the plug-in insert 200, which may be advantageous for certain applications in some embodiments.
[0039] A and B of FIG. 16 show the flow restrictor 250 at a distal position within the plug-in insert 200 relative to the flexible container 1100. The flow restrictor 250 can be disposed along the axis of the plug-in insert 200 at any position that is advantageous for a particular application.
[0040] A and B of FIG. 17 show the flow restrictor 250 at a central position within the plug-in insert 200 relative to the flexible container 1100 and disposed closer to the inlet of the plug-in insert 200 than to the outlet of the plug-in insert 200. The flow restrictor 250 can be disposed along the axis of the plug-in insert 200 at any position that is advantageous for a particular application.
[0041] A and B of FIG. 18 show a right cross-section of the plug 100, with two sets of recesses provided in the cylindrical outer plug wall 102 of the plug 100, allowing it to be inserted into the spout 400 at different depths. A of FIG. 18 shows the long recess 1010 whose distal end terminates at the long recess stopper 1012. B of FIG. 18 shows the short recess 1006 whose distal end terminates at the short recess stopper 1008. The positions of the long recess 1010 and the short recess 1006 are not limiting, and the positions, sizes, and dimensions of the recesses can vary within the scope of the present disclosure.
[0042] A and B of FIG. 19 show a fixture 150 with a mounting bar 1020 and a mounting bar stopper 1022, and the mounting bar 1020 can be arranged along the spout 400 of the fixture 150. In one embodiment of the present disclosure, the fixture 150 is designed to cooperate with the plug 100 and the plug insert 200 within the plug assembly 300 by engagement with the mounting bar 1020. The mounting bar 1020 may include, in one embodiment, two vertical mounting bars 1020 on the outer wall of the spout 400, which may be sized and dimensioned to slide up and down within the short recess 1006 and the long recess 1010 within the plug 100. In a first pre-filling configuration, the mounting bar 1020 may engage with the plug 100 within the short recess 1006 that first terminates at the short recess stopper 1008. The interaction between the mounting bar 1020 and the short recess 1006 may function as a physical barrier to maintain the plug assembly 300 in a pre-filling position. Prior to filling, the plug assembly 300 may be removed from the spout 400. Next, the flexible container 1100 may be filled. Next, in some embodiments, the plug assembly 300 may be rotated 90° about the central axis to align the mounting bar 1020 with the long recess 1010. The angle of rotation may be greater than or less than 90°, and the rotation may only be necessary to the extent that sufficient spacing is ensured between the recess 1006 and the long recess 1010 to avoid interference between them.
[0043] FIG. 20 shows a cross-sectional view of the plug assembly 300 showing the long recess 1010 and the long recess stopper 1012 within the plug 100. The removal and rotation of the plug assembly 300 can be performed by a servo mechanism recognized by those skilled in the art. The plug assembly 300 is repositioned on the spout 400 in a post-filling position, at which time the mounting bar 1020 is inserted into the long recess 1010. In the post-filling position, the plug insert tab 216 may be fixedly engaged with the inner spout tab 414. A seal may be formed by a friction fit or an interference fit between the spout 400 of the fixture 150 and the plug assembly 300 to maintain a sterile environment before and after filling as required.
[0044] As shown in FIG. 21, at the pre-filling position of the plug assembly 300 on the spout 400, the plug assembly 300 is not locked in place by a fixed engagement between the plug insert tab 216 and the inner spout tab 414, as is evident from the presence of a gap 302 between the inner spout tab 414 and the plug insert 200. In one embodiment, in this pre-filling arrangement, the plug assembly 300 is disposed on the spout 400 of the fixture 150 and can be vertically held in a predetermined position within the short recess 1006 by a mounting burst stopper 1022 that engages the short recess stopper 1008. In some embodiments, the plug assembly 300 can be disposed without the assistance of the short recess 1006 and the long recess 1010, and the filling machine can automatically position the plug assembly 300 partially downward along the spout 400 by a presetting mechanism or programming mechanism for the placement distance along the spout 400 and place it in the pre-filling position. In this embodiment of the present disclosure, after the initial placement in the pre-filling position, the plug assembly 300 is removed to fill the flexible container 1100, and then the plug assembly 300 can be fully engaged and disposed in the post-filling position by a preset or programmed mechanism of the filling machine. With the assistance of a servo mechanism, the automatic placement process can be executed.
[0045] In some embodiments, a servo mechanism of the filling machine may be used to dispose the plug assembly 300 on the spout 400. Generally, the method of disposing the plug assembly 300 on the spout 400 may be described in U.S. Pat. Nos. 9,751,677, 10,035,614, and 10,370,165 regarding aseptic plug techniques, each of which is hereby incorporated by reference in its entirety. Modifications to the techniques described in U.S. Pat. Nos. 9,751,677, 10,035,614, and 10,370,165 are described in the present disclosure. With respect to the components of the present disclosure, an appropriate friction fit can be designed to prevent the plug 100 from separating from the plug insert 200 during removal before filling, as is well known to those skilled in the art.
[0046] As shown at A and B in FIG. 22, when filling the flexible container 1100 which can be a pouch, the plug assembly 300 may be removed from the pre - filling position and held by a filling machine, while the filling tube 1050 may be inserted into the spout 400. As shown in FIG. 25, the fluid material 600 which can be a fluid food ingredient may be filled into the flexible container 1100 through the spout 400 of the fixture 150 from a sterile filling machine. When the filling is completed, the filling tube 1050 is removed from the fixture 150 and the pouch assembly 300 is re - positioned on the spout 400 at the post - filling position.
[0047] As shown in FIG. 23, when the plug assembly 300 is re - positioned after filling, in some embodiments, the mounting bar 1020 is positioned at the post - filling position where it is inserted into the long recess 1010. The switching of the placement from the short recess 1006 to the long recess 1010 may be done by rotating the plug assembly 300 after removing it from the fixture 150 for filling the flexible container 1100 or by aligning it in other ways. By this rotation, the positions of the mounting bar 1020 and the long recess 1010 are aligned before the plug assembly 300 is fully pushed onto the fixture 150 on the spout 400. When the plug assembly 300 is fully pushed in and positioned at the final post - filling position, it can be fixedly engaged with the fixture 150 via at least one internal spout tab 414 designed to fixedly engage with at least one plug - in insert tab 216 of the plug - in insert 200. By fixing the plug - in insert 200 in place after the plug 100 is removed, it becomes possible for the user to discharge the fluid substance 600.
[0048] In some embodiments, the internal spout tab 414 of the spout 400 may be replaced with a recess inside the spout 400, in which case, instead of the plug-in insert recess 206, a corresponding protruding plug-in insert tab is used. This embodiment of the present disclosure may be a reversal of the tab and recess embodiment shown in FIG. 23. In this embodiment, since there is no internal spout tab 414 protruding from the internal cylindrical wall of the spout 400 towards the inside of the spout 400, interference that may occur when the filling tube 1050 is inserted into the spout 400 during filling is avoided, whereby the entire diameter of the spout 400 is maintained over its entire length.
[0049] In this embodiment, the protruding plug-in insert tab may first engage a set of recesses at the top of the spout during the pre-filling arrangement. This set of recesses at the top of the spout is in a position offset from the horizontal plane and may have an upper surface inclined towards the distal end of the spout 400 with respect to the flexible container 1100, whereby the plug assembly 300 can be removed for filling without compromising the friction fit between the plug 100 and the plug-in insert 200. In some embodiments, the depth of the recesses at the top of the spout is slightly deeper than the depth to which the plug-in insert tab can protrude into the recesses, thereby preventing the weakening of the friction fit between the plug-in insert 200 and the plug 100. Further, such a configuration avoids the continuous inward pressure that may be exerted on the plug-in insert 200 in the absence of the recesses at the top of the spout, and avoids the deformation that may occur when the protruding plug-in insert tab is constantly compressed during the pre-filling arrangement of the plug assembly 300 or when the flexible container 1100 is stored.
[0050] In this embodiment, the recess at the upper part of the spout is also located at a position offset from the horizontal plane so that the protruding plug insert tab can pass through the recess at the upper part of the spout when the plug assembly 300 is in its final filled position after filling, and may also have a lower surface inclined towards the proximal end of the spout 400 with respect to the flexible container 1100. Here, a protruding plug insert tab that may have a horizontal upper surface can be fixed to the recess at the lower part of the spout that may have a corresponding horizontal upper surface. Thereby, the plug insert 200 is fixed in place, enabling the plug 100 to be separated from the plug insert 200 after filling, and the plug insert 200 and the flow restrictor 250 remain in place to prevent dripping and leakage during use of the flexible container 1100.
[0051] Figures 24A and 24B show where, after the plug 100 has been removed from the spout 400, the plug insert 200 is disposed in the spout 400, thereby forming the plug insert assembly 500. After the plug 100 has been removed from the plug assembly 300, the fluid substance 600 can be discharged from the device.
[0052] Figure 25 shows the inverted fixture 150, with the fluid substance 600 held within the plug insert assembly 500 and the flow restrictor 250 preventing leakage of the fluid substance 600 into the plug insert 200. In one embodiment, the capillary energy created by the small gap in the flow restrictor 250 can contribute to preventing dripping by the flow restrictor 250. In one embodiment, by pressing on the flexible container 1100, the flow restrictor 250 can allow the fluid substance to pass through the plug insert 200 and beyond.
[0053] The magnitude of the resistance exhibited by the flow restrictor 250 against the pressure or force applied to the flow restrictor 250 by pushing the flexible container 1100 can be controlled to prevent the flowable substance 600 from flowing unnecessarily into the plug insert 200. When the target pressure is reached, the flow restrictor 250 may allow the flowable substance 600 to flow into the plug insert 200. The flow restrictor 250 may enable flow at a specific target pressure. In some embodiments, the flow restrictor 250 may not allow the flow of the flowable substance 600 when the pressure is below the target pressure. In some embodiments, a force may be applied to the flexible container 1100 by compression with a plate or roller. In some embodiments, the force may be applied by hand or by a machine. In some embodiments, the resistance to pressure may be adjusted by using different materials having different rigidities or flexibilities, and the resistance to force may be imparted by adjusting or changing the thickness of the material constituting the hinge or hinge 210 of the flow restrictor 250. In some embodiments, an adhesive may be used to impart resistance to pressure. In some embodiments, resistance to pressure may be imparted by providing a thin and brittle link between the surfaces. In some embodiments, a foil seal may be used. In some embodiments, the flow restrictor 250 may be a breakable seal. In some embodiments, a rupturable foil seal may be used, and in some embodiments, the foil may be etched. In an exemplary embodiment, the seal of the flow restrictor 250 can be created using various methods (e.g., heat seal, foil seal, seal using an adhesive, etc.). In some embodiments, the flow restrictor 250 may include structures and methods known to those skilled in the art, while in other embodiments, the flow restrictor 250 may include the structures and methods described in this disclosure.
[0054] FIG. 26 shows the flexible container 1100, the spout 400, and the plug 100. In this embodiment, the flexible container 1100 is a pouch.
[0055] In some embodiments of the present disclosure, a method for filling a flexible container 1100, which can be a sterile pouch, is as follows: providing a flexible container 1100, the flexible container 1100 including a body formed by joining a plurality of panels to form a cavity, a spout 400 providing an entrance to the cavity, the spout 400 having a plug assembly 300 that is sealingly engaged with the spout 400 in a pre-filling position, preventing access to the cavity by being partially pushed along the spout 400, the plug assembly 300 being composed of two parts, a plug 100 and a plug insert 200, and before engaging the plug assembly 300 with the spout 400, inserting the plug insert 200, which may include a flow restrictor 250 for preventing the flow of a fluid substance 600, into the plug 100; cleaning the outer surface of the flexible container 1100; inducing the spout 400 and the plug assembly 300 into a sterile zone, the sterile zone being supplied with a sterilizing gas flowing at a positive pressure; removing the plug assembly 300; filling the flexible container 1100 with the fluid substance 600; repositioning the plug assembly 300 onto the spout 400 and sealing the flexible container 1100 by fully pushing the plug assembly 300 along the spout 400 so that the plug insert 200 is fixedly engaged with the spout 400; removing the spout 400 and the plug assembly 300 from the sterile zone; removing the plug 100 from the spout 400; leaving the plug insert 200 at a predetermined position within the spout to form a plug insert assembly 500, and in some embodiments, providing access to the cavity through a flow restrictor 250, which can be a hinged baffle or valve. In some embodiments, before the plug 100 is removed from the spout 400, the plug 100 can be coupled to a cap, and the cap can be coupled to the spout 400. Thereby, removing the cap also removes the plug 100. Some elements of the methods and structures described herein are described in U.S. Patent No. 10,035,614, which is hereby incorporated by reference in its entirety.
[0056] In some embodiments, the step of coupling the plug 100 to the cap further includes the step of rotatably coupling the cap to the spout 400. In some configurations, the step of providing the flexible container 1100 further includes the step of pre-sterilizing the cavity. In some embodiments, the flexible container 1100 can be sterilized by at least one of gamma rays, X-rays, and electron beams, or other ionizing radiation, before being placed within a filling machine for the flexible container 1100.
[0057] Other embodiments Although the invention has been described in conjunction with its detailed description, it should be understood that the foregoing description is intended to be illustrative, and not limiting, of the scope of the invention as defined by the appended claims. Other aspects, advantages, and modifications are within the scope of the following claims.
Claims
1. An apparatus including a plug assembly attachable to a spout, wherein the plug assembly includes a plug and a plug insert, the plug includes an upper plug wall, an outer plug wall, and an inner plug wall, the outer plug wall and the inner plug wall extend downward from the upper plug wall, the plug insert is adapted to be sealingly attached to the plug, the plug insert includes a plug insert body and means for suppressing the flow of a fluid substance through the spout, the plug insert body, a distal plug insert portion, a central plug insert portion, and a proximal plug insert portion, the distal plug insert portion is in sealing contact with the inner plug wall, the central plug insert portion extends in a vertical plane between the inner plug wall and at least one plug insert recess, the proximal plug insert portion includes the at least one plug insert recess and at least one plug insert tab, the apparatus, wherein when the plug is separated from the plug insert, at least one plug insert tab is adapted to engage at least one inner spout tab when the at least one inner spout tab is disposed within the at least one plug insert recess such that the plug insert is retained within the spout.
2. The apparatus according to claim 1, wherein an inner surface of the outer plug wall and the spout include threads for removably attaching the plug assembly to the spout.
3. The apparatus according to claim 1, wherein an inner surface of the outer plug wall and the spout include a friction fit for removably attaching the plug assembly to the spout.
4. The apparatus according to claim 1, wherein the plug insert recess has a width narrower than the central plug insert portion.
5. The apparatus according to claim 1, wherein an outer wall of the plug is knurled to facilitate gripping.
6. An apparatus including a plug assembly removably and sealably attachable to a spout, wherein the plug assembly includes a plug and a plug insert, the plug insert is adapted to be attached to the plug, The plug insert includes a plug insert body adapted to be removably attached to the plug, and means for suppressing the flow of the fluid substance through the spout. The plug insert and the spout include engagement means for holding the plug insert within the spout when the plug is separated from the plug insert, the device. **Claim 7** The plug insert is adapted to be attached to the plug, the device according to claim 6. **Claim 8** The plug includes an upper plug wall, an outer plug wall, and an inner plug wall. The outer plug wall and the inner plug wall extend downwardly from the upper plug wall. The plug insert body a distal plug insert portion; a central plug insert portion; and a proximal plug insert portion, and the distal plug insert portion is in sealing contact with the inner plug wall. The central plug insert portion extends in a vertical plane between the inner plug wall and at least one plug insert recess, the device according to claim 6. **Claim 9** The proximal plug insert portion includes the at least one plug insert recess and at least one plug insert tab. The at least one plug insert tab is adapted to engage the at least one inner spout tab when the at least one inner spout tab is disposed within the at least one plug insert recess, the device according to claim 8. **Claim 10** The engagement means between the plug insert and the spout is a male-female connector, the device according to claim 6. **Claim 11** The plug insert and the spout are axially disposed, and the plug insert is sized and shaped to fit within the spout, the device according to claim 6. **Claim 12** The means for suppressing the flow of the fluid substance through the spout is a one-way hinged baffle that opens in the distal direction, the device according to claim 6. **Claim 13** The means for suppressing the flow of the fluid substance through the spout is a one-way hinged baffle that opens in the distal direction, the device according to claim 6. **Claim 14** The means for suppressing the flow of the fluid substance through the spout is at least one of a one-way hinge baffle and a valve, and the at least one of the hinge baffle and the valve is adjacent to the plug shaft before the plug is separated from the plug insert to prevent leakage of the fluid material, the apparatus according to claim 6.
15. Removably inserting a plug assembly into a spout, wherein the plug assembly includes a plug and a plug insert, said inserting, removing the plug assembly from the spout, filling a container with a fluid substance through the spout, inserting the plug assembly into the spout in a non-removable manner, removing the plug from the spout while leaving the plug insert in the spout, A method comprising.
16. The plug assembly is inserted for the first time into a pre-filling position in which at least one plug insert tab does not engage with at least one internal spout tab, The plug assembly is inserted for the second time into a post-filling position in which the at least one plug insert tab engages with the at least one internal spout tab, the method according to claim 15.
17. Guiding the positioning of the plug assembly to the pre-filling position by including at least one short recess in the outer plug wall, Further comprising guiding the positioning of the plug assembly to the post-filling position by including at least one long recess in the outer plug wall, The at least one short recess and the at least one long recess are adapted to engage with at least one mounting bar on a fixture, the method according to claim 16.
18. The plug insert includes at least one of a baffle and a valve, the method according to claim 15.
19. Further comprising capping the plug before removing the plug from the spout, the method according to claim 15.
20. The method is aseptic, the method according to claim 15.