WO2025170673A1

WO2025170673A1 - Pop up container closure

Info

Publication number: WO2025170673A1
Application number: PCT/US2024/060147
Authority: WO
Inventors: Virgil Claudiu MANTA; Mihai Alexandru MAIER
Original assignee: Baxter Healthcare SA; Baxter International Inc
Current assignee: Baxter Healthcare SA; Baxter International Inc
Priority date: 2024-02-06
Filing date: 2024-12-13
Publication date: 2025-08-14
Anticipated expiration: 2026-08-06

Abstract

New and improved container outlet valve closures are provided for medical solution containers. The closures are flexible and keep the solutions in their containers until acted upon. By applying a certain force on the closure, a pop-up valve is opened to permit flow of the medical solution from the container. The closures may be used with a variety of materials. Closure opening is easily activated and does create particle pollution for the medical solution. Closures for sidewall mounted and gondola style containers are provided.

Description

POP UP CONTAINER CLOSURE

Background

[0001] The present disclosure relates to medical fluid containers such as soft-walled flexible bags or semi-rigid containers for IV solutions and renal solutions used in IV therapies, dialysis therapies and the like and especially to the features used to control their outlet openings.

[0002] Currently, medical container closures generally have employed two classical closure types. The first is a frangible type which is a breakable system. This closure type often creates undesirable particles which are contaminants in the solution and these frangible closures are very fragile. The second classical closure type is the peelable seal applied to the solution bag. Peelable seal closures are also fragile. Moreover, these classical approaches are generally plastic dependent. A need still exists for new and improved container closures which may be used with a variety of materials that do not create particle pollution and are simple to activate to open the container and permit the solution to flow out.

Summary

[0003] The present disclosure provides a flexible container closure able to keep the solution inside the container until the user wants to get access to it. By applying a certain force, the user can activate a pop up system and the solution can flow freely into the coil conduit for conveyance to a dialysis system, for example. The container closure may be employed with several solution container types. In a first embodiment, a one piece molded container closure, typically made from a thermoplastic elastomer material compatible with polyolefin films, may be used to control the access and outflow for the container.

[0004] In a first embodiment, a container closure for flexible and semi-rigid containers is provided in a flexible or semi-rigid fluid container closure comprising:

[0005] a valve body extending axially between a container contacting end having a first diametrical dimension with an annular face and a central opening leading to an interior cavity and an opposed top wall extending parallel to and spaced from the annular face having a second smaller diametrical dimension, a double ended elongate cylindrical shaft extending axially through the top wall from an inner end having an inner end face disposed in the cavity at a point intermediate the annular face and the top wall to an opposed outer end spaced from the top wall outside the cavity, the shaft including a central fluid passageway, the inner end including at least one window opening communicating with the central passageway, the valve body including a foldable collapsible peripheral sidewall bounding the cavity extending from the container contacting end to the top wall, the sidewall being movable between an inwardly folded closed position in which the inner end face is positioned adjacent the annular face in the central opening and an extended open position in which the end face is spaced inwardly away from the annular face, whereby the container closure in the closed position may be welded to a container wall along the annular face and along the end face and movement of the valve body from the closed position to the open position is effective to rupture the container wall or a foil seal between the annular face and the end face, thereby permitting fluid to flow from the container through the window opening into the central passageway. In this embodiment the outer end is connectable with a matable coil conduit, preferably through a luer connection well known to those skilled in the art. This container closure is best suited to be used with containers made from olefin polymers and copolymers especially those which comprise polypropylene.

[0006] In a second embodiment, a flexible or semi-rigid fluid container closure comprises:

[0007] a base member having a planar disk like configuration including opposed major surfaces and a central orifice extending therethrough;

[0008] a valve body extending axially between a base contacting end having a first diametrical dimension with an annular face and a central opening leading to an interior cavity and an opposed top wall extending parallel to and spaced from the annular face having a second smaller diametrical dimension, a double ended elongate cylindrical shaft extending axially through the top wall from an inner end having an inner end face disposed in the cavity at a point intermediate the annular face and the top wall to an opposed outer end spaced from the top wall outside the cavity, the shaft having a central fluid passageway, the inner end including an exterior barb disposed peripherally adjacent the inner end face and at least one lateral window opening communicating with the central fluid passageway, the body including a foldable collapsible peripheral sidewall bounding the cavity extending from the base contacting end to the top wall, the sidewall being movable between an inwardly folded closed position in which the barb on the inner end extends from and is sealingly received within the central orifice of the base and an extended open position in which the inner end and barb are spaced from the central orifice,

[0009] the base member being welded to the valve body in the closed position along the annular face and along the barb whereby the container closure in the closed position may be welded to a container wall and the container wall may be perforated adjacent the flow aperture of the base and thereafter movement of the valve body from the closed position to the open position is effective to pull the barb out of the central orifice thereby permitting fluid to flow from the container through the central orifice to the lateral window openings and into the central passageway.

[0010] In a third embodiment, a flexible or semi-rigid fluid container closure comprises:

[0011] a base member having a disk like configuration including opposed major surfaces including an outer facing surface and an inner facing surface, the inner facing surface including a central upstanding receptacle with central recess and a distal peripheral latch recess, the base having at least one flow aperture defined therein;

[0012] a valve body extending axially between a base contacting end having a first diametrical dimension with an annular face and a central opening leading to an interior cavity and an opposed top wall extending parallel to and spaced from the annular face having a second smaller diametrical dimension, a double ended elongate cylindrical shaft extending axially through the top wall from an inner end having an inner end face disposed in the cavity at a point intermediate the annular face and the top wall to an opposed outer end spaced from the top wall outside the cavity, the shaft including a central fluid passageway, the inner end of the shaft including a frontal opening communicating with the central passageway, the valve body including a foldable collapsible peripheral sidewall bounding the cavity extending from the base contacting end to the top wall, the sidewall being movable between an inwardly folded closed position in which the inner end face is disposed in the receptacle recess and an extended open position in which the end face is spaced inwardly from the receptacle, the valve body further including a plurality of elongate, spaced, resilient cantilevered latch arms extending inwardly from the top wall at a point intermediate the sidewall and the shaft and having a free end disposed in the cavity between the inner end face and the top wall, the free end of each latch arm including a latch proj ection extending radially inwardly and peripherally adjacent the free end having a latch shoulder positioned for cooperative latching engagement with a distil latch recess of the receptacle,

[0013] the base member being welded to the valve body in the closed position along the annular face such that the inner end is sealingly received within the upstanding receptacle, and the latch projections are received in the latch recesses, whereby the container closure in the closed position may be welded to a container wall and the container wall perforated adjacent the flow aperture of the base and thereafter movement of the valve body from the closed position to the open position is effective to displace the latch arms out of the latch recesses and move the inner end of the shaft out of sealing engagement in the upstanding receptacle exposing the frontal opening to permit fluid to flow from the container through a flow aperture into the frontal opening and into the central passageway and out to a destination for the fluid, such as a coil conduit connected to the outer end of the shaft.

[0014] In accordance with a fourth embodiment, a flexible or semi-rigid fluid container closure comprises:

[0015] a base member having a disk like configuration including opposed major surfaces including an outer facing surface and an inner facing surface, the inner facing surface including a central upstanding receptacle, the base having at least one flow aperture defined therein;

[0016] a valve body extending axially between a base contacting end having a first diametrical dimension with an annular face and a central opening leading to an interior cavity and an opposed top wall extending parallel to and spaced from the annular face having a second smaller diametrical dimension, a double ended elongate cylindrical shaft extending axially through the top wall from an inner end having an inner end face disposed in the cavity at a point intermediate the annular face and the top wall to an opposed outer end spaced from the top wall outside the cavity, the shaft including a central fluid passageway, the inner end including at least one opening communicating with the central passageway, the valve body including a peripheral sidewall bounding the cavity extending from the base contacting end to the top wall, the valve body sidewall including a first cylindrical section extending from the annular face to a point intermediate the annular face and the top wall and a second foldable collapsible section extending from the first cylindrical section to the top wall, the sidewall being movable between an inwardly folded closed position in which the inner end face is sealingly received within the upstanding receptacle and an extended open position in which the end face is spaced from the receptacle, the valve body further including lateral side mounting flanges projecting outwardly from the first cylindrical section for facilitating welding the valve body between two opposed sheets of film of a bag container,

[0017] the base member being welded to the valve body in the closed position along the annular face so that the upstanding receptacle extends into the cavity and the inner end face is sealingly received within the upstanding receptacle whereby, the container closure in the closed position may be welded into a container seam between two sheets of container film and thereafter movement of the valve body from the closed position to the open position is effective to permit fluid to flow from the container through the flow aperture and into the central passageway.

[0018] The closures provided by this disclosure are compatible and weldable to a variety of container materials. Opening action does not create particles to contaminate the medical solution. The closures are easy to activate to open the pop up valves. The closures work well with sidewall mounted closures or outlet valves and also with gondola style closures and containers.

Brief Description of the Drawings

[0019] Fig. l is a perspective view of the lower portion of a renal solution bag container with the new and improved container closure welded to the lower sidewall of the solution bag.

[0020] Fig. 2 is an elevated side view of a renal solution bag container provided with a gondola style container closure in accordance with an alternate embodiment of the present disclosure wherein the container closure is shown welded between two layers of film in the bottom seam of the bag.

[0021] Fig. 3 is a schematic view of another flexible soft walled solution bag container in an unfilled condition with the new and improved container closure welded to the lower sidewall of the container film.

[0022] Fig. 4 is a perspective view of a solution container filled with a medical fluid shown in the closed condition with a coil conduit received over the outer end of the shaft.

[0023] Fig. 5 is a perspective view of the valve body of new and improved container closure in accordance with a first embodiment with the valve body shown in an open condition.

[0024] Fig. 6 is a schematic cross-sectional view of the valve body of Fig. 5 shown in an open position with inner shaft shown in phantom lines. [0025] Fig. 7 is a perspective view of the valve body of Fig 5 shown in a closed condition.

[0026] Fig. 8 is a cross-sectional view of the closed container closure of Fig. 7 with an optional foil layer cover extending over the central opening.

[0027] Fig. 9 is a schematic cross-sectional view showing the container closure of Fig. 8 after activation to the open position and showing the rupture of the foil layer in a separated condition.

[0028] Fig. 10 is schematic perspective view of the rigid base member in accordance with a second embodiment of the container closure in accordance with this disclosure.

[0029] Fig. 11 is a schematic view partly in section of the alternate valve body in accordance with the second embodiment shown in the closed position.

[0030] Fig. 12 is an elevated cross-sectional view of the container closure of the second embodiment showing the barb seal engagement between the closed valve body of Fig. 11 and the base member of Fig. 10, shown in the closed position ready for welding to a container sidewall.

[0031] Fig. 13 is a rear perspective view of another alternate container closure in accordance with the third embodiment shown in the open position.

[0032] Fig. 14 is a perspective front view of the bell-shaped valve body in accordance with a third embodiment shown in the closed position.

[0033] Fig. 15 is a perspective view of the alternate base member of the third embodiment.

[0034] Fig. 16 is a cross-sectional view of the valve body and the base in closed condition in accordance with the third embodiment.

[0035] Fig. 17 is a cross-sectional view of the valve body and the base in welded and open condition in accordance with the third embodiment.

[0036] Fig. 18 is a perspective view of a valve body in accordance with a fourth embodiment of the container closure.

[0037] Fig. 19 is a cross-sectional view of the valve body shown in Fig. 18 in the closed position.

[0038] Fig. 20 is a perspective view of the base member of the fourth embodiment.

[0039] Fig. 21 is a perspective view of the assembled and welded container closure of the fourth embodiment shown in the closed position. [0040] Fig. 22 is a cross-sectional view of the assembled and welded container closure of the fourth embodiment shown in the closed position.

[0041] Fig. 23 is a cross-sectional view of the assembled and welded container closure of the fourth embodiment shown in the open position.

Detailed Description

[0042] Figs. 1 and 2 show the use of the new and improved container closure 18 connected to two common types of solution containers. In Fig. 1, the bag container 10 is made by folding a selected polymer film forming two sidewalls. The edges are sealed by heat welding to provide an open topped bag. In one common context, the three sided bag envelope being formed may be filled with medical solution and a top edge seal with an inlet port tubing welded into the seam may be formed. Fig. 1 shows a bottom portion of polymer bag 10 including edge seams 16 and a bottom fold 14. The bag sidewalls 12 are made from a suitable polymer film material, preferably comprising a polyolefin film such as polyethylene or polypropylene or blends or copolymers thereof. The new and improved container closure 18 of the disclosure is shown welded to the lower end of the bag 10 on sidewall 12. The container closure 18 is shown in an open flowing condition. Closure 18 includes a flexible valve body 20 having a bell shape. The valve body is elongated and extends from a bag contacting end 22 to a spaced apart top wall 26. Bag contact end 22 has an annular face 24 which is welded and sealed to the bag sidewall 12. Closure 18 includes a movable shaft for opening and closing the valve. The free outer end 28 of the shaft may be coupled to a coil tubing conduit for a dialysis treatment machine. The connection to the coil may be any suitable conduit or tubing connection method, e g. matable Luer connectors.

[0043] Fig. 2 shows a medical fluid container with a gondola style outlet port configuration. This bag body 34 has film sidewalls 36, edge seals 38 and bottom seal 40. The new and improved gondola style container closure 42 of the disclosure is shown welded into the bag 34 between two layers of film in the bottom seal 40. The container closure 42 has a cylindrical body with mounting wings clearly visible in the bottom seam 40.

[0044] Turning now to Figs, 3 and 4, an unfilled and a filled renal solution container is shown respectively. Unfilled solution bag 52 includes top seam 54, side seams 56, bottom seam 58, and a welded inlet port 64 with inlet tube 60 and a cap 62. Container closure 18 is welded to the lower end of the bag sidewall to provide a leak proof valve for containing a medical solution during handling, shipment and storage. Fig. 4 shows the filled solution bag 68 ready for use or shipment. Bag 68 has a coil conduit 72 connected to the outer end of shaft 28. The new and improved container closure 18 is located at a lower side wall, well positioned to dispense the solution contents using gravity.

[0045] In greater detail and referring now to Figs. 5-9, a new and improved container closure 18 in accordance with a first embodiment of the disclosure is shown. Closure 18 includes an elongate bell-shaped valve body 20 having a first bag contacting end 22 including an annular face 24 with a central opening 78 leading to an inner cavity 80. A top wall 84 extends generally parallel to and spaced from the bag contacting end 22. The top wall 84 has a diametrical dimension c that is smaller than the diametrical dimension b of bag contacting end 22 as illustrated in Fig. 11. Closure 18 is generally symmetrical about a longitudinal axis, a. An elongate double ended shaft 82 extends axially through top wall 84 from an inner end 74 having an inner end face 88 disposed in cavity 80 at a point intermediate annular face 24 and top wall 84 to an outer end 28 which extends beyond top wall 84 located outside of cavity 80. Shaft 82 has a central passageway 76 extending therethrough for conducting fluids along the length of the shaft and to a central exit opening 78 in the outer end 28. Inner end 74 includes at least one fluid flow window opening 90 disposed between the inner end 74 and top wall 84 communicating with central passageway 76.

[0046] Valve body 20 includes a foldable collapsible peripheral sidewall 85 bounding cavity 80 extending between bag contacting end 22 and top wall 84. Sidewall 85 is movable between an inwardly folded and closed position as shown at 86 in Figs. 7-8. In the closed position the inner end face 88 of shaft 82 is positioned adjacent the annular face 24 in the central opening 78. In the closed position top wall 84 is advanced forwardly to lie relatively closer to bag contacting end 22 and sidewall 85 is folded as shown at 86. Sidewall 85 is also movable to an extended open position as shown in Figs. 5-6 and 9, In the open position, inner end face 88 is spaced away from annular face 24 to lie inwardly within the cavity and top wall 84 is spaced relatively outwardly from the bag contacting end. Sidewall 85 is no longer collapsed and folded but is now unfolded and extended as indicated at 92 in Fig. 9.

[0047] Container closure 18 in the closed position is welded to either a flexible container film 12 as shown in Figs. 1 and 3, or a metal foil layer 99 as shown in Figs. 8-9, welding all along the annular face 24 and along the inner end face 88. Heat welding generally reduces the thickness of the layers being welded and reduces the tear strength of the container film. Closure 18 will remain in the closed position unless it is forceably activated by pulling on outer end 28 (or by pulling on a coil conduit connected to outer end 28) to flip the closure from the closed position to the open position. The act of moving the closure from the closed to the open position is effective to rupture the container film 12 of the container wall or the metal foil layer 99 between the annular face weld and the end face weld as shown in Fig. 9. In the open position shown in Fig. 9, container fluid flows through the ruptured film opening around retracted inner end 74 into the side fluid flow window openings 90 on shaft 82 into the central passageway 76, out through central opening 78 and out into a conduit connected to outer end 28. This flow path is indicated by arrow f as shown in Fig. 9.

[0048] In a preferred embodiment shown in Fig. 8 central opening 78 is sealed or closed by a foil layer 99. Foil 99 is welded to valve body about annular face 24 and inner end face 88. In this sealed condition, closure 18 may be sterilized, packaged and shipped for later affixation to a container. Foil layer 99 may be peeled or torn off prior to welding to a container film or it may remain in place during subsequent welding to the container sidewall or container outlet orifice.

[0049] In accordance with the preferred first embodiment, the valve body 20 comprises a one- piece unitary integral shaped molded part. Preferably the valve material is a thermoplastic elastomer (TPE) compatible with polyolefin container films. These materials are well known to those skilled in this art.

[0050] The TPE material selected should have the required flexibility and toughness when molded into the bell shape and be compatible with the container materials as well as the medical fluids. The container closure in accordance with the first embodiment is especially adapted for use on containers comprising polypropylene. This is because the closure is designed to break the container film in use and polypropylene containing films do not fragment into particles. Other container films, especially those comprising polycarbonate, fragment into particles which could contaminate the medical fluid which is unacceptable or the fragments may occlude the flow through the closure which is also unacceptable. In preferred embodiments, the container sidewall film comprises polypropylene and the container closure comprises a blend of polypropylene and polyamide, especially preferably 75% of Bormed RD808CF™ (polypropylene) and 25% of Kraiburg TM5MHD SIOOB™ (polyamide). In other preferred embodiments, the container sidewall film comprises polyethylene and the container closure comprises a blend of polyethylene, polyamide and polyacrylonitrile. [0051] The withdrawal force that must be exerted on the coil conduit and outer end of the shaft should not be so low as to permit unintentional opening of the closure. The withdrawal force should not be so high that medical personnel are unable to move the closure from the closed position to the open position by pulling outwardly on the outer end of the shaft or a coil connector connected to the outer end. The combination of the film thinning at the welding lines, the tear strength of the container film itself and a preload force of the valve body which must be overcome to flip the closure from closed to open and maintain it in the open position all factor into calculating the withdrawal force desired. Typical withdrawal forces for the container closure used with popular flexible bag packaging for renal solutions is from about 3 to 10 psi (0.2 to 0.7 kg/cm²). Preferably the displacement distance to activate the closure from closed to open position is from about 5 to about 20mm, especially about 10mm.

[0052] Reference is now made to a second embodiment of a new and improved container closure 113 shown in Figs. 10 - 12. As shown in Fig. 12, the closure 113 includes a different valve body 114 shown in the closed position. Valve body 114 includes an annular face 24 similar to the previous embodiment which is provided with an annular shoulder 118 which defines a base-receiving recess for flush mounting of a base 120 into annular face 24, as shown in Fig. 12. A major difference and improvement is provided at the inner end 126 of valve body 114 by having a barb seal feature 116 at the tip of shaft 130 adjacent inner end face 128. Inner end 126 is also provided with lateral side windows 90 which communicate with the central passageway 134. Closure 113 includes a disk shaped base 120 having a central orifice 124 as shown in Fig. 10.

[0053] The assembled closure 113 is shown in Fig. 12. The base is mounted into the base receiving recess defined by annular shoulder 118 provided in annular face 24. In the closed position, sidewall 86 is collapsed and folded inwardly and the inner end face 128 projects outwardly through central orifice 124 so that barb sealing section 116 sealingly engages central orifice 124 of the base 120. In accordance with this embodiment, the base material is a harder polyolefin molded part. The valve body 114 is molded from a polymer blend which is softer and resilient, such that when the outer end 138 is inserted into central orifice 124, the barb sealing section 116 deforms and resiles back about the central orifice 124, firmly inserting the shaft 130 into the base 120. The closure 113 is welded along the perimeter of the base 120 and annular face 24 and also about the barb sealing section 116 and central orifice 124. [0054] Closure 113 may be welded to a container sidewall along annular face 24 and along inner end face 128. A perforator may be used to create a container opening adjacent the inner end face 128. In the open position of closure 113 (not shown), outer end 138 of shaft 130 is pulled outwardly, popping the sidewall 86 to expanded unfolded condition and inner end 126 is withdrawn from the central orifice of the base 120. In the open position, fluid may flow through the central orifice 124 into the lateral windows 136 into the central passageway 134 and out through outer end 138.

[0055] Referring now to Figs. 13 through 17, a third embodiment of the new improved container closure 100 in accordance with this disclosure is shown. In this embodiment, closure 100 comprises two separate parts, which are welded together before being attached to a container sidewall. More particularly closure 100 comprises a base member 102 as shown in Figs.13 and 15. Base 102 has a planer disc-shaped configuration, including an inner face 104 and an outer face 106. An upstanding receptacle 108 is provided on inner face 104. Base 102 further includes a plurality fluid flow apertures 110. Upstanding receptacle 108 includes a frusto-conical central recess 111 for receiving the inner end 74 of the valve body 92 in the closed position, best shown in Figs. 16 - 17. Upstanding receptacle 108 is also provided with a distal latch receiving peripheral recess 103.

[0056] One major difference in valve body 92 from valve body 20 in the first embodiment is that the inner end 74 is not provided with any fluid flow windows 90 and instead a frontal opening 112 is provided in the inner end face 88 which communicates with the central passageway 76 in shaft 82. The valve body 92 further includes a plurality of elongate, spaced, resilient cantilevered latch arms 105 and 107, extending inwardly from the top wall at a point intermediate the sidewall and the shaft and having a free end 109 disposed in the cavity between the inner end face and the top wall. The free end 109 of each latch arm 105,107 includes a latch projection 113 extending radially inwardly and peripherally adjacent the free end 109 having a latch shoulder 115 positioned for cooperative latching engagement with a distil latch recess 103 of the receptacle 108.

[0057] In the assembled closed position of closure 100 shown in Fig. 16, the inner surface of the base is welded to the annular face 24 of valve body 92. Closure 100 in the closed position with the base 102 assembled and welded to the annular face 24 of valve body 92 may be mounted and welded to a container sidewall, by welding along the periphery of the closure 100. Thereafter, the container sidewall may be perforated adjacent the fluid flow apertures 110. In the closed position the inner end 74 is slidably and sealingly received in recess 111 so that frontal opening 112 is closed off and the latching shouldersl 15 on the latch projections 113 of latch arms 105, 107 are latchingly received in the distil peripheral latch recess 103. In the closed position, no container fluid may flow from fluid flow apertures 110 into frontal opening 112 which is sealingly closed off by seating in the inner end 74 in recess 111 of upstanding receptacle 108.

[0058] Fig. 17 shows closure 100 in an open position in which outer end 28 has been pulled outwardly to pop the sidewall 92 to its extended and expanded position similar to Fig. 9. In the process of moving closure 100 from the closed position to the open position, inner end 74 is retracted from the base 102 and the inner end face 88 with frontal opening 112 is outwardly spaced away from upstanding receptacle 108 so that container fluid may flow through the fluid flow openings 110 around upstanding receptacle 108 into the frontal opening and passageway 76 to flow into an attached coil conduit as shown by flow arrow h.

[0059] Turning now to the fourth embodiment of the new and improved closure 140 in accordance with this disclosure depicted in Figs. 18-23. Figs. 18-19 depict the valve body in a closed position before being assembled to the base 182. Fig. 20 shows the base member 182. Figs. 21-22 show the new and improved closure 140 in a closed position with the valve body 142 welded to the base member 182. Fig. 23 shows the closure 140 after activation in an open condition.

[0060] Closure 140 is intended for gondola style closure as depicted in Fig. 2.

[0061] Closure 140 includes a valve body 142 and a base member 182. Valve body

142 extends from a disk contacting end 144 having a central opening 174 and an interior cavity 170 to a top wall 146. Shaft 150 extends from an inner end 160 positioned at base contacting end 144, in the closed position shown in the Figs.18-19 and 21, to a spaced and opposed outer end 148 extending outwardly through the top wall 146. Shaft 150 includes a central passageway 176. The inner end 160 includes an inner end face 162 with an opening 168 communicating with passageway 176. Valve body 142 includes a sidewall 153 extending from base contacting end 144 to top wall 146 bounding cavity 170. Sidewall 153 includes a relatively rigid cylindrical section 154 leading to a foldable collapsible section 156. Side mounting flanges 178 extend outwardly from cylindrical section 154.

[0062] Closure 140 includes a base member 182 shown in Fig. 20. Base member 182 is a planar disk having an outwardly facing surface 186, an inner facing surface 184 and an upstanding receptacle 188 projecting from the inner facing surface 184. Base member 182 has at least one flow aperture 190 and in accordance with the preferred embodiment shown there are four flow apertures 190 provided in base member 182. The assembled and welded closure 140 is shown in the closed position in Fig. 21.

[0063] Closure 140 is assembled by inserting base member 182 in the central opening so that the inner end 160 is fully sealingly seated in upstanding receptacle 188. The periphery of base member 182 is welded to the disk contacting surface 192. As was true of the other embodiments, closure 140 is moved to an open position by pulling on outer end 148 which pops section 156 to an unfolded extended position. The inner end 160 is displaced outwardly a sufficient amount so that inner end face 162 is freed from upstanding receptacle 188 as shown in Fig. 23.

[0064] Closure 140 is welded into the bottom seam of a solution container between two layers of film as shown in Fig. 2. When closure 140 is pulled to an open position by pulling downwardly on outer end 148 or a coil conduit connected to the outer end 148, medical fluid flows from the container through flow apertures 190, through inner end opening 168 into central passageway 176 and out through shaft passageway opening 152 in outer end 148.

[0065] The closures provided in each of the disclosed embodiments are all effective to close and seal the containers for shipment, storage and handling without opening or leaking because of their respective retention features including welding, barbing or latching. All require a definite intended application of force to move the closures from closed to open position by pulling rearwardly or downwardly on the outer end of the shaft or a conduit connected to the outer end. The closures stay closed unless acted upon and once opened, remain open unless acted upon. The new and improved container closures may be used with a variety of materials, do not create particle pollution and are simple to activate to open the container and permit the solution to flow out.

Claims

CLAIMS What is claimed is:

1. A flexible or semi-rigid fluid container closure comprising: a valve body extending axially between a container contacting end having a first diametrical dimension with an annular face and a central opening leading to an interior cavity and an opposed top wall extending parallel to and spaced from the annular face having a second smaller diametrical dimension, a double ended elongate cylindrical shaft with a central fluid passageway extending axially through the top wall from an inner end having an inner end face disposed in the cavity at a point intermediate the annular face and the top wall to an opposed outer end spaced from the top wall outside the cavity, the inner end including at least one window opening communicating with the central passageway, the body including a foldable collapsible peripheral sidewall bounding the cavity extending from the container contacting end to the top wall, the sidewall being movable between an inwardly folded closed position in which the inner end face is positioned adjacent the annular face in the central opening and an extended open position in which the end face is spaced inwardly away from the annular face, whereby the container closure in the closed position may be welded to a container wall along the annular face and along the end face and movement of the valve body from the closed position to the open position is effective to rupture the container wall between the annular face and the end face, thereby permitting fluid to flow from the container through the window opening into the central passageway.

2. A container closure as defined in Claim 1, wherein the outer end includes a luer connector for connecting the container and closure to a matable luer connector on the end of a coil conduit.

3. A container closure as defined in Claim 1 wherein the closure is a one piece molded part.

4. A container closure as defined in Claim 1 wherein the closure comprises a thermoplastic elastomer.

5. A container closure as defined in Claim 1 wherein the valve body comprises polypropylene and polyamide.

6. A container closure as defined in Claim 5 wherein the valve body comprises a blend of about 75% by weight polypropylene and 25% by weight polyamide.

7. A container closure as defined in Claim 1 further including a foil layer welded to the annular face and the inner end face in the closed position covering the central opening.

8. A container closure as defined in Claim 1 wherein the valve remains in a closed position until a requisite withdrawal force is applied on the outer end of the shaft to move the valve body to the open position.

9. A flexible or semi-rigid fluid container including a film sidewall comprising polypropylene and a container closure as defined in Claim 1 welded to the film sidewall in the closed position and welded along the annular face and the along the inner end face.

10. A flexible or semi-rigid fluid container closure comprising: a base member having a planar disk like configuration including opposed major surfaces and a central orifice extending therethrough; a valve body extending axially between a base contacting end having a first diametrical dimension with an annular face and a central opening leading to an interior cavity and an opposed top wall extending parallel to and spaced from the annular face having a second smaller diametrical dimension, a double ended elongate cylindrical shaft with a central fluid passageway extending axially through the top wall from an inner end having an inner end face disposed in the cavity at a point intermediate the annular face and the top wall to an opposed outer end spaced from the top wall outside the cavity, the inner end including an exterior barb disposed adjacent the inner end face and at least one fluid flow window opening, the valve body including a foldable collapsible peripheral sidewall bounding the cavity extending from the disk contacting end to the top wall, the sidewall being movable between an inwardly folded closed position in which the barb on the inner end extends from and is sealingly received within the central orifice of the base and an extended open position in which the inner end and barb are spaced from the central orifice, the base member being welded to the valve body along the annular face and along the barb and orifice whereby the container closure in the closed position may be welded to a container wall and the container wall may be perforated adjacent the flow aperture of the base and thereafter movement of the valve body from the closed position to the open position is effective to permit fluid to flow from the container through the central orifice and fluid flow window opening into the central passageway.

11. A container closure as recited in Claim 10 wherein the annular face includes a shoulder defining a base receiving recess and the base is disposed in the recess and welded in place so that in the closed position, the barb extends outwardly through the central orifice.

12. A container closure as defined in Claim 10, wherein the outer end includes a luer connector for connecting the container and closure to a matable luer connector on the end of a coil conduit.

13. A container closure as defined in Claim 10 wherein the valve body comprises polypropylene and polyamide.

14. A container closure as defined in Claim 13 wherein the valve body comprises a blend of about 75% by weight polypropylene and 25% by weight polyamide.

15. A container closure as defined in Claim 10 wherein the valve body comprises a blend of about 80% by weight polyethylene and about 20 % of a blend of polyamide and polyacrylonitrile.

16. A container closure as defined in Claim 10 wherein the valve remains in a closed position until a requisite withdrawal force is applied on the outer end of the shaft to move the valve body to the open position.

17. A flexible or semi-rigid fluid container including a film sidewall comprising polyethylene and a container closure as defined in Claim 10 welded to the film sidewall in the closed position and welded along the annular face and the along the barb and central orifice.

18. A flexible or semi-rigid fluid container closure comprising: a base member having a disk like configuration including opposed major surfaces including an outer facing surface and an inner facing surface, the inner facing surface including a central upstanding receptacle with a central recess and distal peripheral latch recess, the base having at least one flow aperture defined therein; a valve body extending axially between a base contacting end having a first diametrical dimension with an annular face and a central opening leading to an interior cavity and an opposed top wall extending parallel to and spaced from the annular face having a second smaller diametrical dimension, a double ended elongate cylindrical shaft extending axially through the top wall from an inner end having an inner end face disposed in the cavity at a point intermediate the annular face and the top wall to an opposed outer end spaced from the top wall outside the cavity, the shaft including a central fluid passageway, the inner end of the shaft including a frontal opening communicating with the central passageway, the valve body including a foldable collapsible peripheral sidewall bounding the cavity extending from the base contacting end to the top wall, the sidewall being movable between an inwardly folded closed position in which the inner end face is disposed in the receptacle opening and an extended open position in which the end face is spaced inwardly from the receptacle, the valve body further including a plurality of elongate, spaced, resilient cantilevered latch arms extending inwardly from the top wall at a point intermediate the sidewall and the shaft and having a free end disposed in the cavity between the inner end face and the top wall, the free end of each latch arm including a latch projection extending radially inwardly and peripherally adjacent the free end having a latch shoulder positioned for cooperative latching engagement with a distil latch recess of the upstanding receptacle, the base member being welded to the valve body in the closed position along the annular face such that the inner end is sealingly received within the central recess of the upstanding receptacle, and the latch projections are received in the latch recess, whereby the container closure in the closed position may be welded to a container wall and the container wall perforated adjacent the flow aperture of the base and thereafter movement of the valve body from the closed position to the open position is effective to displace the latch arms out of the latch recesses and move the inner end of the shaft out of sealing engagement in the upstanding receptacle exposing the frontal opening to permit fluid to flow from the container through a flow aperture into the frontal opening and into the central passageway to the outer end.

19. A container closure as defined in Claim 18, wherein the outer end includes a luer connector for connecting the container and closure to a matable luer connector on the end of a coil conduit.

20. A container closure as defined in Claim 18 wherein the valve body comprises polypropylene and polyamide.

21. A container closure as defined in Claim 18 wherein the valve body comprises a blend of about 75% by weight polypropylene and 25% by weight polyamide.

22. A container closure as defined in Claim 18 wherein the valve body comprises a blend of about 80% by weight polyethylene and about 20 % of a blend of polyamide and polyacrylonitrile.

23. A container closure as defined in Claim 18 wherein the valve remains in a closed position until a requisite withdrawal force is applied on the outer end of the shaft to move the valve body to the open position.

24. A flexible or semi-rigid fluid container including a film sidewall comprising polyethylene and a container closure as defined in Claim 18 welded to the film sidewall in the closed position and welded along the annular face.

25. A flexible or semi-rigid fluid container closure comprising: a base member having a disk like configuration including opposed major surfaces including an outer facing surface and an inner facing surface, the inner facing surface including a central upstanding receptacle, the base having at least one flow aperture defined therein; a valve body extending axially between a base contacting end having a first diametrical dimension with an annular face and a central opening leading to an interior cavity and an opposed top wall extending parallel to and spaced from the annular face having a second smaller diametrical dimension, a double ended elongate cylindrical shaft with a central fluid passageway extending axially through the top wall from an inner end having an inner end face disposed in the cavity at a point intermediate the annular face and the top wall to an opposed outer end spaced from the top wall outside the cavity, the inner end including at least one opening communicating with the central passageway, the valve body including a peripheral sidewall bounding the cavity extending from the disk contacting end to the top wall, the sidewall including a first cylindrical section extending from the annular face to a point intermediate the annular face and the top wall and a second foldable collapsible section extending from the first cylindrical section to the top wall, the sidewall being movable between an inwardly folded closed position in which the inner end face is sealingly received within the upstanding receptacle and an extended open position in which the end face is spaced from the receptacle, the valve body further including lateral side mounting flanges projecting outwardly from the first cylindrical section for facilitating welding the valve body between two opposed sheets of film of a bag container, the base member being welded to the valve body in the closed position along the annular face so that the upstanding receptacle extends into the cavity and the inner end face is sealingly received within the upstanding receptacle, whereby the container closure in the closed position may be welded into a container seam between two sheets of container film and thereafter movement of the valve body from the closed position to the open position is effective to permit fluid to flow from the container through the flow aperture and into the central passageway.

26. A container closure as defined in Claim 25, wherein the outer end includes a luer connector for connecting the container and closure to a matable luer connector on the end of a coil conduit.

27. A container closure as defined in Claim 25 wherein the valve body comprises polypropylene and polyamide.

28. A container closure as defined in Claim 25 wherein the valve body comprises a blend of about 75% by weight polypropylene and 25% by weight polyamide.

29. A container closure as defined in Claim 25 wherein the valve body comprises a blend of about 80% by weight polyethylene and about 20 % by weight of a blend of polyamide and polyacrylonitrile.

30. A container closure as defined in Claim 25 wherein the valve remains in a closed position until a requisite withdrawal force is applied on the outer end of the shaft to move the valve body to the open position.