BRPI0706436A2 - one-way valve and apparatus and method of use thereof - Google Patents

Abstract

UNIDIRECTIONAL VALVE AND APPARATUS AND METHOD OF USE A flexible bag and valve assembly is provided for aseptically storing a substance, releasing multiple parts of the stored substance, and keeping the remaining substance in the bag in an airtight, sealed, atmospheric condition. environment. The valve assembly and flexible pouch may be received in a relatively rigid housing, and are adapted to cooperate with a pump to pump discrete portions of substance from the pouch and through the one-way valve to release substance from it. The assembly comprises a flexible pouch defining in this a variable volume storage chamber sealed from the ambient atmosphere for aseptically storing multiple parts of the substance therein. A one-way valve in the assembly includes a valve housing defining an axially extending valve base and at least one flow opening extending through the valve housing and / or valve base. A valve cap is mounted on the valve housing and includes an axially extending portion formed of an elastic material covering the base of the valve and covering a substantial portion thereof extending axially. The valve part defines a predetermined radial thickness and forms an interference fit with the valve base. The valve part and valve base define an axially extending joint between them forming a normally closed valve opening extending axially, and the valve part is moved radially between (1) a normally closed position with the valve portion engaged. (ii) an open position with at least one radially spaced valve portion segment of the valve base for connecting the valve port in fluid communication with at least one flow port and thereby allowing passage of substance from the variable volume storage chamber through the valve opening. In normally closed and open positions, the one-way valve maintains remaining substance in the variable volume storage chamber in an aseptic and sealed condition with respect to the ambient atmosphere.

Description

"UNIDIRECTIONAL VALVE AND APPARATUS AND METHOD OF USE

OF THE SAME"

Cross Reference to Related Patent Applications

This patent application is a continuation in part of U.S. Patent Application Serial No. 11 / 295,274, filed December 5, 2005 entitled "One-Way Valve and Apparatus Using It", and claims priority for the application. Provisional Patent Application No. 60 / 757,161 filed January 5, 2006 entitled "One-way Valve and Apparatus and Method of Use". Each of the foregoing patent applications is incorporated herein by reference in its entirety as part of present description.

Field of the Invention

The present invention relates to one-way valves and apparatus and methods using them, and more particularly to one-way valves defining valve bases and flexible valve caps over the valve bases, and the dosers and packaging incorporating such valves. and their methods of use.

Background of the Invention

Aseptic packaging is widely used to extend the shelf life of food and beverages. With conventional masseptic packaging, the product is filled and sealed in the package under sterile, bacteria-free conditions. In order to maximize shelf life before opening, the product and packaging material can be sterilized prior to pre-filling, and it is performed under conditions that prevent product contamination. Such a prior art metering system employing aseptically filled packaging is shown in U.S. Patent No. 6,024,242. The package includes a pouch that holds the food or drink, and an open-ended flexible tube connected to the pouch to release the product through it. A diaphragm valve is used on the dispenser to compress the open end of the tube and thereby close it from the ambient temperature. In order to release the product, the diaphragm valve is released from the tube, and the product is in turn allowed to flow from the bag and through the open end of the tube.

One of the disadvantages of this type of prior art dispenser and packaging is that during installation of the pouch and tube assembly in the dispenser and during release there is a risk that bacteria and other unwanted substances may enter the open end tube. and contaminate the product. If the product is a non-acidic product, such as a milk product, it must be kept refrigerated to ensure the life of the product.

It is an object of the present invention to overcome one or more of the disadvantages described above in the prior art.

Summary of the Invention

According to a first aspect, the present invention is directed to a flexible valve and pouch assembly for aseptically storing a substance, releasing multiple parts of the substance stored therein, and maintaining the remaining substance in the substance. bag in an aseptic condition sealed from the ambient atmosphere. The valve assembly and flexible bag are receivable in a relatively rigid housing, and are adapted to cooperate with a pump to pump discrete portions of substance from the bag and through the one-way valve to release the substance therefrom. The assembly comprises a flexible pouch defining therein a sealed ambient volume variable volume storage chamber for aseptically storing multiple parts of the substance. A one-way valve in the assembly includes a valve housing defining an axially extending valve base. and at least one flow opening extending through at least one of the valve housing and the valve base. A valve cap is mounted on the valve housing, and includes an axially extending portion formed of an elastic material over the valve base and covering a substantially axially extending portion thereof. The valve part defines a predetermined radial thickness and forms an interference fit with the valve base, the valve part and the valve base define an axially extending joint forming an normally closed axially extending valve opening, and the valve part is radially movable between (i) a normally closed position with the valve part engaged with the valve base, and (ii) an open position with at least one segment of the valve part radially spaced from the valve base. The valve to connect the valve port in fluid communication with at least one flow port and thereby allow passage of substance from the variable volume storage chamber through the valve port. In normally closed and open positions, the one-way valve keeps the remaining substance in the variable return storage chamber in an aseptic condition and sealed from the ambient atmosphere.

In some embodiments of the present invention, the flexible pouch defines an aseptic, empty, sealed storage chamber adapted to receive a substance to be stored and released therefrom. In some embodiments of the present invention, the flexible pouch is aseptically filled with a substance that is at least one of a food and a beverage. In such an embodiment, the pouch is formed of a plastic laminate including an oxygen / water barrier and an approved food contact layer. In such fashion, the substance is selected from the group which includes a milk, milk, evaporated milk, condensed milk, cream, half milk and half cream, baby formula, growing milk. , yogurt, soup, ice cream, juice, syrup, coffee, condiments, ketchup, mustard, mayonnaise, and coffee aroma.

Some embodiments of the present invention further comprise a flexible tube coupled in fluid communication to the bag and the one-way valve by at least one of (i) a fitment mounted on at least one flexible pocket and the one-way valve which it engages by a snap on a respective end of the pipe to form an airtight seal between them, (ii) a heat seal, (i-ii) a weld, and (iv) an adhesive.

In some embodiments of the present invention, the assembly additionally includes an electrical activator coupled in fluid communication between the bag and the one-way valve that is manually moved to pump substance from the variable volume storage chamber through the one-way valve. In such an embodiment, the electrical activator is approximately dome-shaped. Some such modalities additionally comprise a manually engaged operator which is manually engaged to press the electric activator and in turn release substance from the variable volume storage chamber via one-way valve. In some such embodiments, the manually engaged operator is a lever.

In some embodiments of the present invention, the assembly further comprises a relatively rigid container receiving the flexible pouch. In some such embodiments, the relatively rigid container is made of paper or plastic.

In another aspect, the present invention is directed to the assembly in combination with a dispenser.

The dispenser comprises a relatively rigid container housing the flexible pouch, and a surface for supporting and positioning the one-way valve to release substance from it and into another container. In such a mode, the dispenser additionally includes a pump operably coupled between the variable volume storage chamber and the one-way valve, and a control unit electrically coupled to the pump to control pump operation and in turn control the pump. release of substance into the variable volume storage chamber through the one-way valve and the other container. In such an embodiment, the dispenser includes at least one pouch, and at least one pouch includes at least one of coffee, coffee concentrate, milk, milk product, half milk and half cream, and cream. In such an embodiment, the dispenser further includes at least one coffee aroma-containing pouch.

In another aspect, the present invention is directed to a flexible bag and valve assembly for aseptically storing a substance, releasing multiple parts of the stored substance, and maintaining the remaining substance in the pouch in one container. aseptic condition sealed with respect to the ambient atmosphere. The valve assembly and flexible pouch may be received in a relatively rigid housing and adapted to cooperate with a pump to pump discrete portions of substance from the pocket and through the one-way valve to release the substance from it. The assembly comprises first device by defining in it a flexible variable volume storage chamber sealed with respect to the ambient atmosphere to aseptically store multiple parts of the substance. The assembly additionally comprises second device to allow substance from the storage chamber. variable volume is released through it, and to keep the remaining substance in the variable volume storage chamber in an aseptic condition and sealed from the ambient atmosphere during and after releasing the substance from it. The second device includes the third device for forming an axially extending valve base and at least one flow opening and also includes the fourth device mounted on the third device by defining an elastic portion extending axially over the third device and covering a portion. substantially extending axially, defining a predetermined radial thickness and forming an interference fit with the third device, and defining an axially extending junction between the third and fourth device, to form a normally closed, axially extending valve opening, and to radially move between (i) a normally closed position with the fourth device engaging the third device, and (ii) an open position with at least one segment of the fourth spacer device radially of the third device for connecting the valve port in fluid communication with at least one flush opening and thus allow the passage of substance from the variable volume storage chamber through the valve opening. The fourth device cooperates with the third device for maintaining the remaining substance in the variable volume storage chamber in an aseptic and sealed condition with respect to the ambient atmosphere in normally closed and open locations.

In one embodiment of the present invention, the variable volume storage chamber contains a milk-based product, and the second device is to substantially prevent microorganisms from entering the variable-volume storage chamber and to allow the milk-based product to be stored. and released without refrigeration.

In one embodiment of the present invention, the first device is a flexible pouch, the second device is a one-way valve, the third device is a valve housing and the fourth device is a flexible valve cap.

In another aspect, the present invention is directed to a method for storing fluid and releasing multiple parts of the stored fluid comprising the following steps:

(1) providing a storage chamber and storing multiple parts of the fluid therein in an aseptic condition;

(2) providing a one-way valve assembly which includes (i) a valve housing defining a valve base and a flow opening extending through at least one of the valve housing and valve base; and (ii) a valve cap formed of an elastic material which includes a valve part over the valve base, wherein the valve part defines a predetermined radial thickness and forms an interference fit with the valve base, the valve part and valve base define a normally closed valve opening extending axially therebetween, and the valve part is moved relative to the valve base between a normally closed position with valve apart engaging the valve base, and an open position with at least one segment of the spaced valve portion of the valve base for connecting the valve port in fluid communication with the flow port and thereby allowing fluid to pass from the flow port through the port. valve opening; and

(3) keep the fluid in the storage chamber in aseptic condition for life and release fluid through the one-way valve assembly.

In some embodiments of the present invention, the method further comprises the step of providing a hermetically sealed variable volume storage chamber and storing multiple parts of the fluid therein in a substantially airless condition, and maintaining the fluid in the storage chamber. of substantially airless variable volume during service life and release fluid through one-way valve assembly. In some embodiments of the present invention, the method further comprises the step of providing a pump coupled between the storage chamber and the one-way valve assembly and pumping discrete portions of fluid from the storage chamber through the opening through the opening. flow, and in turn through the valve port.

In some embodiments of the present invention, the method further comprises the steps of: (i) providing at least one of the storage chamber, pump assembly and one-way valve with a thermally releaseable and needle penetrable portion; and (ii) filling the storage chamber with fluid by penetrating the thermally releasable, needle-penetrable portion with a needle, introducing fluid through the needle and the storage chamber, withdrawing the needle, and hermetically releasing a The resulting needle noise is thermally releasable and needle penetrable by applying thermal energy thereto.

In such an embodiment, the method further comprises the step of forming a substantially transparent needle-penetrable thermally releasable portion by combining (i) a styrene block copolymer; (ii) an oleofine; (iii) a pigment added in an amount of less than approximately 150 ppm; and (iv) a lubricant. In such an embodiment, the pigment is a substantially nearly transparent infra-red absorber.

In some embodiments of the present invention, the variable volume storage chamber is defined by (i) a flexible pouch, including, for example, the interior of a flexible pouch, or the space between a flexible pouch and a relatively rigid container or shell. or (ii) a rigid casing including, for example, a slidingly recessed piston in the casing, and forming a fluid impermeable seal between a peripheral portion of the step and the casing, and defining the chamber variable-volume storage space between the piston and the one-way valve assembly flow opening. In an alternate embodiment, the container or other housing defines the storage chamber and includes a filter coupled in fluid communication between the storage chamber and the ambient atmosphere to filter air or other gas flowing into the chamber upon the release of fluid from it to sterilize air or other gases flowing in the chamber and thereby maintain an aseptic condition of the fluid in the chamber. In each case, the method further comprises the step of sterilizing the flexible, empty, sealed variable volume storage chamber or other storage chamber prior to filling it. Preferably, the sterilizing step includes at least one of (i) transmitting radiation, such as gamma radiation or electron defect, and (ii) transmitting a deflected sterilant, such as VHP, in the storage chamber.

In such embodiments of the present invention, the method comprises the step of aseptically filling the storage chamber with at least one of a milk-based product, a baby formula, and a water-based product. Such an embodiment further comprises the step of maintaining the milk-based product, the baby formula or the substantially preservative-free water-based product substantially throughout the filling and release of the product. Such an embodiment further comprises the step of keeping the milk product, the baby formula, and the water product substantially at room temperature for the entire shelf life and releasing multiple doses of the product from the storage chamber.

Some embodiments of the present invention further comprise the steps of: (i) providing a flexible tube coupled at one end in fluid communication with the storage chamber, and coupled at another end in fluid communication with an assembly. one-way valve, and a pump in the form of a peristaltic pump; and (ii) engaging with the peristaltic pump an external part of the hose and pumping discrete portions of fluid therethrough.

Other embodiments of the present invention further comprise the steps of: (i) providing a pump in the form of a manually engaging pump or a pedal activated pump including a compression chamber, a compressive surface received in the compression chamber, and a manually engaging or coupling actuator to pedal at least one between the compression chamber and the compressive surface; and (ii) manually engaging the manually engaging activator or engaging the pedal and moving the activator or pedal with at least one of the compressive surface and the compression chamber relative to the other between a rest position and at least one activated position, and in turn pressurize fluid into the compression chamber and release it through the one-way valve assembly.

An advantage of the apparatus and method of the present invention is that the unidirectional valve assembly can hermetically seal the product in the variable volume storage chamber for the entire life and multiple release of the product. As a result, non-acidic products, such as milk-based products, do not require refrigeration during their product life or use. Other advantages of the apparatus and method of the present invention will become apparent from the following detailed description and accompanying drawings.

FIG. 1 is a side elevational view of an apparatus embodying the present invention including a one-way valve and tube assembly;

FIG. Figure 2 is a schematic view of a dispenser engaging the one-way valve and tube assembly in combination with a storage reservoir as a released substance, and a pump for pumping the substance from the reservoir through the one-way valve assembly and tube;

FIG. 3 is a cross-sectional view of the one-way valve assembly of FIG. 1;

FIG. 4 is a front perspective view of the one-way valve assembly of FIG. 1;

FIG. 5 is a front perspective view of another embodiment of a one-way valve assembly with the removed flexible valve cap, and including a chamfered edge on the release tip to prevent collection of the tip after release;

FIG. 6 is a partial cross-sectional view of the valve housing and adjustment of the one-way valve assembly of FIG. 5;

FIG. 7 is a partial cross-sectional schematic view of a valve assembly, flexible bag, and tube received in a box and mounted on a dispenser;

FIG. 8 is a perspective view of the flexible shell, tube and valve assembly of FIG. 7;

FIG. 9 is an exploded cross-sectional view of a door located in the flexible pouch of FIG. 7 including a laser-release or needle-penetrable plug to penetrate the needle-plug and fill the pouch with a fluid and laser-release the resulting needle-hole in the plug after removing the needle therefrom;

FIG. 10 is a perspective view of another embodiment of a valve assembly of the present invention including a manually engaging dome-shaped activator for pumping fluids through the valve where it is mounted in a housing and coupled in fluid communication with a localized flexible pouch. In the box;

FIG. 11 is a cross-sectional view of the valve assembly of FIG. 10;

FIG. 12 is a rear view of the valve assembly of FIG. 11;

FIG. 13 is a top perspective cross-sectional view of the valve assembly of FIG. 11;

FIG. 14 is a side elevational view of the valve assembly of FIG. 11 connected to the flexible pouch;

FIG. 15 is a cross-sectional perspective view of the valve assembly of FIG. 11 connected to a solid housing including a slidingly received piston therein and forming with the housing a variable volume storage chamber;

FIG. 16 is a cross-sectional view of another embodiment of a valve assembly, dome-shaped activator, and fluid-coupled flexible pouch with the dome-shaped activator and valve assembly mounted in a relatively rigid container;

FIG. 17 is a top plan view of the snap ring of the assembly of FIG. 17 securing the domed integrated actuator and valve cap to the container;

FIG. 18 is a top plan view of the vaulted integral activator and valve cap of FIG. 16;

FIG. 19 is a schematic cross-sectional view of another apparatus of the invention including an expandable bladder or pouch mounted in a relatively rigid container defining a variable volume storage chamber therebetween, and a unidirectional pump and valve assembly coupled in fluid communication with the chamber. volume storage device to release fluid product from it

FIG. 20 is a schematic cross-sectional view of another apparatus of the invention including a container defining a storage chamber therein, a microbicidal filter coupled in fluid communication between the ambient atmosphere and the storage chamber for filtering and in turn sterilizing air flowing into the chamber, and a pump and a one-way valve assembly coupled in fluid communication with the storage chamber to release fluid product therefrom;

FIG. 21 is a schematic cross-sectional view of another apparatus of the invention including a flexible pouch defining a variable volume storage chamber mounted in a relatively rigid container, a pressurized source or other coupled gas in fluid communication with the chamber formed between the flexible pouch and the container for pressurizing fluid product in the bag, and a release valve and one-way valve assembly in-fluid communication with the variable volume storage chamber to release pressurized fluid into the storage chamber through the directional valve;

FIG. 22 is a schematic cross-sectional view of another apparatus of the invention including a manually or pedal-activated peristaltic pump for pumping fluid product from the variable volume storage chamber through the one-way valve; and

FIG. 23 is a schematic cross-sectional view of another apparatus of the invention including a manually actuated swingarm pump to pump fluid product from the variable volume storage chamber through the one-way valve.

Detailed Description of the Invention

In FIGs. 1 and 2, an apparatus embodying the present invention is indicated generally by reference numeral 10. Apparatus 10 comprises a one-way valve assembly 12 connected in fluid communication with a tube 14. Apparatus 10 is used for hermetically sealing a substance in tube 14 to the ambient atmosphere and paralyzing the substance through the one-way valve assembly 12. The substance may take the form of any of the numerous different products which are currently known. or later known, including without limitation any of the numerous different food and drink products, such as milk products, including milk, evaporated milk, condensed milk, cream, half milk and half cream , baby formula, growing milk, yogurt, soup, low acidic fluids, non-acidic fluids, and any of the numerous other liquid nourishing products, ice cream (including daily and non-daily, such as soy-based ice cream) , juice, syrup, coffee, condiments such as ketchup, mustard and mayonnaise, gases such as coffee aroma, and biological or biopharmaceuticals such as vaccines, co therapies m monoclonal genes and antibodies.

With reference to FIG. 2, apparatus 10 is mounted on a dispenser 16 comprising a pump 18 which is connectable to tube 14 to compress the tube and in turn release a substance in the tube through the one-way valve 12 and a container 20. The doser also includes a reservoir 22 which In the embodiment illustrated, it defines a variable volume storage chamber 24 for storing the released substance. The reservoir 24 includes a fit 26 connected to the end of the tube 24 opposite the one-way valve12 and coupled in fluid communication between the tube and the variable volume storage chamber 24 to allow for substance passage from the storage chamber. pipe. Alternatively, the tube may be heat-sealed, welded, adhesively bonded, or otherwise connected to the reservoir, or material forming the reservoir, such as a plastic or laminated pouch, of any of a number of different shapes which are known, or will become known later. The dispenser 16 also includes a housing 28 for enclosing the components as illustrated, and includes access panels or other openings in a manner known to those skilled in the art to allow access to the interior of the housing to install a fresh reservoir when it is empty, and / or to repair or replace components.

As shown in FIG. 3, the one-way valve assembly 12 includes a valve housing 30 defining an axially extending first passage 32, an axially extending valve base 34, and a flow opening 36 extending axially through the valve housing 30 adjacent to the valve base 34 and coupled in fluid communication with the axially extending first passage 32. The one-way valve assembly 12 further includes a valve cap 38 formed of an elastic material and including a cap base 40 mounted in the valve housing 30 and securely secured against axial movement relative thereto, and a valve portion 42 on the valve base. The valve part 42 defines a predetermined radial thickness and an inner diameter D1 smaller than the outer diameter D2 of the valve base 34 to thereby form an interference fit therebetween, as indicated by the overlapping lines. in FIG. 3. As can be seen, valve part 42 and valve base 34 define a normally closed valve opening or junction extending axially 44 therebetween. As further described below, valve portion 42 is moved radially between a normally closed position as shown in FIG. 3, with the valve portion 42 engaging the valve base 34, and an open position (not shown) with at least one radially spaced valve segment segment 42 of the valve base 34 for connecting the valve opening 44 in fluid communication with the valve port. flow 36 thereby to allow the passage of substance from the flow passage 36 through the valve opening 44. As also shown in FIG. 3, an adjustment 46 is fixedly secured to the valve housing 30 and forms an airtight seal between them. Fit 46 defines a second passage 48 coupled in fluid communication with the first axially extending passage 32 to allow substance flow therebetween, and an axially extending pipe connection surface 50 which is hermetically connectable to tube 14 with the second passage48. coupled in fluid communication with the tube to thereby allow substance to pass from the tube 14 through the second passage 48 and in turn through the first axially extending passage 32, flow opening 36 and valve opening 44 .

As shown in FIG. 3, the valve housing 30 additionally includes a housing base 52 including an annular mounting flange 54 extending radially outwardly to mount the valve assembly, for example, in the dispenser 16 of FIG. 2. The valve housing 30 also deforms a substantially frusto-conical first portion 56 extending between the housing base 52 and the valve base34. As can be seen, the flow opening 36 extends axially through the first substantially frusto-conical portion 56 such that the radially inner edge of the flow opening 36 is substantially contiguous with valve base 34. Valve cap 38 includes a second substantially frusto-conically portion 58 extending between cap base 40 and valve portion 42, over the substantially substantially frusto-conical portion 56 of valve housing 30, and as indicated by overlapping lines in FIG. 3, forming an interference fit between them.

As can be seen from FIG. 3 each of the substantially frusto-conical portion and valve portion 58 and 42, respectively, of valve cap 38 defines a progressively decreasing radial thickness when moving axially in one direction from substantially frusto-conical portion 58. towards valve part 42. As a result, progressively lower energy is required to open the valve when moving axially inwardly toward the outside of the valve. Substance is released through the valve by pumping the substance at a sufficient pressure (either manually, mechanically or electro-mechanically by compressing the tube 14, or otherwise pumping the substance through the tube or valve) through from flow port 36 to open valve port or junction 44 (the "valve port pressure"). Since the pressurized substance enters the valve opening or junction 44, progressively less energy is required to open the respective axial segments of the valve cap progressively when moving axially inwardly toward the exterior of the valve. As a result, the valve itself operates as a pump to force the substance through the normally closed valve opening 44.

Preferably, a substantially annular segment of valve part 42 engages valve base 34 substantially throughout any substance release period through valve opening 44 to maintain an airtight seal between valve opening 44 and the ambient atmosphere. If desired, the valve may be configured in other ways to progressively require less energy to open the valve (i.e. to decrease the valve opening pressure) when moving in the axial direction from the interior toward the outside of the valve. For example, valve cap 38 and valve housing 30 may define a decreasing degree of interference between them when moving inwardly and outwardly of the valve assembly. Alternatively, valve base 34 may define a progressively increasing diameter when moving axially in one direction from an inner end toward a distal end of the valve base (or from the inner end to the outer end of the valve base). valve it). If desired, the valve assembly may include only one of these characteristics, or may include any desired combination of these characteristics to achieve the desired performance characteristics.

Valve assembly 12, otherwise, is preferably constructed in accordance with the teachings of the following co-pending patent applications assigned therein which are incorporated herein by reference in their entirety as part of the present description: North Patent Application Serial No. 10 / 640,500, filed August 13, 2003, entitled "Valve and Recipient Assembly for Storing and Releasing Substances", and Related Method, U.S. Patent Application Serial No. 29 / 174,939 , filed January 27, 2003, entitled "Valve Assembly and Container", U.S. Patent Application Serial No. 60 / 613,583, filed September 27, 2004, entitled "Side Activated Dispenser with One-Way Valve for Storing" and Release Quantities of Substances ", U.S. Patent Application Serial No. 29 / 188,310, filed August 15, 2003, entitled" Valve and Tube Assembly ", U.S. Patent Application Serial No. 29 / 191,510, filed Oct. 7, 2003, entitled "Valve Assembly and Container", and U.S. Patent Serial No. 60 / 528,429, filed December 10, 2003, entitled "Valve Set and Tube Kit for Storing and Releasing Substances, and Related Method".

According to such teachings, at least one of the valve base diameter D2, the degree of interference between valve part 42 and valve base 34 (as indicated by the overlapping lines in FIG. 3), The predetermined radial thickness of the valve portion 42 and a predetermined modulus of elasticity of the valve cap material 38 is selected to: (1) define a predetermined valve opening pressure generated by tube compression. 14 allowing passage of the substance from the tube through the normally closed valve opening44, and (2) hermetically sealing the valve 12 and preventing the entry of bacteria or contamination through the valve opening 4 and into the tube 14 in the normally closed position. . The illustrated embodiment of the present invention, each of the valve base diameter D2, the degree of interference between valve part 42 and valve base 34, the predetermined ra-dial thickness of valve part 42, and the predetermined elasticity modulus of the valve cap material38 is selected to (1) define a predetermined valve opening pressure generated by compression of the tube 14 which allows passage of the substance from the pipe (or storage chamber). variable volume coupled with fluid communication thereto) through the valve opening44, and (2) hermetically sealing the valve opening 44 and preventing bacteria or contamination from entering the pipe into the normally closed position.

Flow opening 36 extends angularly with respect to the valve base. In the illustrated embodiment, the flow opening extends angularly in the range of approximately 30 ° to approximately 45 °. However, as may be recognized by those skilled in the relevant art based on the teachings provided herein, this angular range is exemplified only, and may be changed if desired or otherwise required. In addition, one or more additional flow apertures 36 may be added and angularly spaced from the aperture 36 as shown, for example, in any of the same co-pending patent applications incorporated by reference above.

As shown in FIG. 3, the valve housing 30 defines an annular recess 60 formed at the base joint 52 and the frusto-conical portion 56. The valve cover 38 includes a corresponding annular flange 62 which projects radially inwardly, is received in the annular recess 60 of the valve housing 30 to secure the valve cap to the valve housing. As can be seen, valve housing 30 defines a conical surface 64 on the front or axially outer side of annular recess 62 to facilitate movement of flangeanular 62 in annular recess 60.

Valve assembly 12 further includes a protective cap or shield 66 that extends annularly around the flexible valve cap 38, and extends axially from the valve cap base 38 to a point adjacent the valve release tip, but axially spaced into it. As shown in FIG. 3, valve housing 30 defines a first peripheral recess 68 formed at the junction of mounting flange 54 and housing base 52, and valve guard 66 defines a corresponding first annular protuberance 70 which projects radially inwardly and engages. in the peripheral recess 68 to lock the valve switch in the valve housing. In addition, the valve protector 66 defines a second peripheral recess 72 formed on the axially internally lateral first annular protrusion 70, and the casing base 52 defines a corresponding second protrusion 74 that projects radially outwardly and engages the peripheral recess. 72 to additionally lock the valve guard to the valve housing.

As also shown in FIG. 3, valve guard 66 is spaced radially with respect to the second frusto-conical portion 58 and valve portion 42 of valve cover38 to form an annular gap 76 extending axially therebetween. The gap 76 allows the valve cap to freely expand or move radially outwardly during release of substance through the valve opening or normally closed junction 44. Tip 78 of valve portion 42 defines an annular portion 80 which radially narrows to it is directed toward the distal end 82 of the valve guard 66 to substantially block or block a substantial part of the distal end of the annular gap 76 to thereby prevent any unwanted substances from depositing therein.

The fitting 46 includes an annular mounting flange 84 which is received in a corresponding mounting recess 86 for mounting the fitting to the valve housing 30. As shown in FIG. 3, the valve housing and fit form an interference with the inner annular surfaces 88 and 90 of this to allow the valve housing and fit to be ultrasonic welded together and form a hermetic seal. between them the annular hitch line of these surfaces. An advantage of the illustrated shear joint design is that it ensures relatively high joint strength and an airtight seal through it. As may be recognized by those skilled in the relevant art based on the teachings provided, the valve housing and fitting may be connected to each other in any number of different ways which are currently known, or which will be known later on. Alternatively, the adjusting and valve housing may be formed integral with one another when molding them. An advantage of forming the separate fit of the valve housing is that different adjustment sizes, and / or different types of adjustments, can be connected to the valve housings. As shown in FIG. 3, the pipe connecting surface 50 is a conventional barbed fit surface that frictionally engages the inside of the hose 14 to secure the fit to the tube and form an airtight seal therebetween. In the illustrated embodiment, tube 14 is a conventional silicone tube. However, as may be recognized by those of ordinary skill in the art based on the teachings provided herein, the fit and / or tube may take the form of any of a number of different configurations and / or may be formed of any of the numerous different materials which are currently known, or will later be known.

As shown in FIG. 2, the tube valve assembly 10 may be mounted on a dispenser 16 and connected to a conventional peristaltic pump 18 which is rotatably driven, as indicated by the arrows in FIG. 2 to compress the tube 14 and in turn pump substance from the reservoir 24 through the one-way valve 12 and into a receiving container or other receptacle 20. Alternatively, the valve and tube assembly 10 may be mounted on any of the many different containers or dosers, and may be used in combination with any of a number of different pumps, such as electrically activated, manually activated, or pedal activated pumps, or may be used with dispensers employing pressurized air or other gas to pump fluid through the valve, which are currently known or will be known later.

In FIGs. 5 and 6, another valve assembly embodying the present invention is indicated generally by reference numeral 112. Valve assembly 112 is substantially similar to the valve assembly 12 described above, and thus reference numerals. Similar values preceded by the number "1" are used to indicate similar elements. The primary difference from valve assembly 112 compared to valve assembly 12 is that the valve base release tip 134 defines a recess 192 therein, and an annular chamfered edge. very thin 194 formed between the recess 192 and the distal edge of the valve base 134. As can be seen, the radial width of the beveled edge 194 is substantially less than the axial depth of the recess 192 and the valve base diameter 134 (e.g. a magnitude in both cases of at least about 5, and preferably at least about 10). In one embodiment of the present invention, the radial width of the edge portion is in the range of approximately 5 mm to approximately 25 mm. An advantage of this configuration is that the thin annular rim 194 substantially prevents any substance from being collected at the release point after being released from the valve. Preferably, valve 112 is mounted in a substantially vertical and perpendicular orientation (as shown typically). 2) such that the release tip is turned downward (or such that the valve shaft is oriented substantially perpendicular or at an acute angle to the horizontal). The light surface area of annular edge 194 substantially prevents any surface flowing fluid from having sufficient surface tension to overcome the force of gravity that pulls downward and parallel flow of such surface. As a result, the annular edge194 substantially prevents any fluid or other substance from being collected on it, and thus facilitates the maintenance of a clean release tip.

In FIGs. 7-9, another tube and valve assembly employing the present invention is indicated generally by reference numeral 210. The tube and valve assembly 210 is substantially similar to the tube valve assemblies 10, 110 described above, and thus reference numerals. Similar numbers preceded by the number "2" or preceded by the number "2" instead of the number "1" are used to indicate similar elements. A primary difference of valve and tube assembly 210 compared to the valve and tube assemblies described above is that the tube 214 is formed integrated with the flexible bag forming the reservoir 224, and the valve, tube and flexible bag assembly may be mounted in a relatively rigid housing 225. In one embodiment, the inlet end 226 of the tube 214 is embedded in the 222, such as by heat sealing, ultrasonic welding, crimping, or adhesively connecting the tube to the bag material. Based on the relevant art, based on the teachings herein, the tube may be connected in or formed fluid communication with the bag in any of a number of different forms which are currently known or will be known thereafter.

As indicated in FIG. 7, when mounted in the housing of the dispenser 216, the tube 214 is coupled to a peristaltic pump 218 of a type known to those skilled in the relevant art, and the valve assembly 212 extends through an opening. 221 formed in a panel 223 of the metering housing 216. As can be seen, the mounting flange 254 is seated on the inner side of the panel 223, and a clamp 229 with one or more suitable fasteners 221, such as thumbscrews, which formally lock valve 212 in place. A control unit 233 is electrically coupled to the pump 218 to control the operation of the pump and in turn control the release of the food or beverage product into reservoir 224 from bag 222 through tube 214 of one-way valve assembly 212 , and in the cup or other receptacle220. The dispenser may include suitable controls which enable a user to activate control unit 233 and pump218, such as buttons or switches, all of a type known to those skilled in the relevant art.

In one embodiment, the bag material 222 is an oxygen / water barrier material. One such e-exemplified material is a plastic laminate having a layer of approved food contact material. In such an embodiment, the material is a heat-sealed film including an oxygen / water barrier layer and preferably an outer layer exhibiting appropriate wear and flexibility properties. Examples of suitable outer layers are nylon, either linear or bi-axially oriented, polyethylene, polypropylene, and polystyrene. Examples of oxygen / water layer materials are ethylene vinyl alcohol (EVOH) and silicon oxide. An exemplary heat-sealed material is polyethylene such as low linear density, ultra-low density low density, high density or metallocene catalyzed polyethylene. An exemplary pouch material is a laminate comprising an outer nylon-EVOH copolymer and inner metallocene catalyzed polyethylene, where the laminate layers are adhered together in a manner known to those of skill in the art. As can be appreciated by those skilled in the art, if the tube is not provided as an integral part of the bag, anti-block additives should be avoided to ensure good tube / bag edge fusion.

The tube 214 is preferably effect of a material which is soft enough that it may be compressed or otherwise deformed, for example by the peristaltic pump218, but does not puncture or deform permanently when compressed or deformed. In one embodiment of the present invention, the material is a coextruded metallocene catalyzed polyethylene, such as metallocene catalyzed resin by Dow Chemical Corporation under the trademark Dow AG8180. As indicated above, the tube material may be hot sealed, crimped, or adhesively bonded to the pouch material.

The dimensions of tube 214 may be adapted to the type of food material or other substance to be released therethrough. In some embodiments, the inner diameter of the pipe is in the range of approximately 5 mm to approximately 15 mm, and preferably is in the range of approximately 7 mm to approximately 8 mm. In some such embodiments, the thickness of the tube material is in the range of approximately 1 mm to approximately 2 mm, and in one such embodiment, the thickness is approximately 1.5 mm. The length of the tube 214 may be configured as desired or otherwise required by a particular release system. In some embodiments, the length of the tube is in the range approximately 15 cm to approximately 25 cm. As may be appreciated by those skilled in the relevant art based on the teachings provided herein, valve, tube and bag assembly construction materials may take the form of any of the numerous different materials which are currently known, or which will subsequently be known to perform the functions of the materials. their components. Similarly, the dimensions of these components, and the way in which they are connected or otherwise, may take any of the numerous different dimensions or configurations as desired or otherwise required. For example, the materials of the pouch, or the dimensions of the pouch and dotubo, may be the same as those described in U.S. Patent No. 6,024,252, which is expressly incorporated herein by reference in its entirety as part of the disclosure. presented description.

Depending on the design of the dispenser housing 216, it may not be necessary to arrange the pouch 222 in the box25. However, box 225 may provide a convenient mechanism for holding and carrying flexible pouch 222, and / or for mounting pouch 222 in dispenser housing 216. In one embodiment of the present invention, box 216 is a cardboard box. a type known to those skilled in the relevant art. As shown in FIG. 9, housing 225 may define an opening 227 extending through a base wall thereof which allows the valve assembly and tube to be passed therethrough. Alternatively, housing 25 may be provided with a perforated or breakable portion allowing part of the housing to be removed to access the valve and pipe assembly. As can be appreciated by those skilled in the relevant art based on the teachings provided herein, the box may be formed of any of numerous different materials, and may define any of a number of different shapes and / or configurations, which are currently known, or which will be thereafter. In addition, the flexible bag and valve assembly may be mounted in any of the numerous different containers or dispensers, and may be used in combination with any of a number of different pumps, such as manually activated, electrically activated pumps, or footswitches, or may be used with dispensers that employ pressurized air or other gas to pump or otherwise pressurize fluid to flow through the valve, which are currently known or will be thereafter.

As shown in FIGs. 7 - 9, pouch 222 preferably includes a thermally release and needle-penetrable plug 235 to fill the reservoir 224 through the plug with a needle or other injection member, and thermally release the resulting common needle orifice. laser or other thermal or chemical source. As can be seen, the plug 235 is mounted or otherwise received in a door 237 extending through an upper portion of the pocket 222. As shown in FIG. 9, door 237 may extend through an opening formed in an upper wall of housing 225. If desired, a support ring 239 may be located between a flange 241 of door 237 and the surrounding wall of housing 225. As shown in FIG. As can be seen, the support ring 239 extends laterally (or radially outwardly) from the door to support it during fill-up and release through the plug. The valve assembly, tube and pouch are preferably sterilized before filling, for example by applying radiation such as gamma or electron beam radiation to them, or another type of sterilant such as peroxide. of vaporized hydrogen ("VHP"). Then, the empty, sterilized, and hermetically sealed valve assembly, tube and pouch are aseptically filled with a liquid food, beverage or other substance to be contained therein. An advantage of this method of filling and construction is that it provides increased life of the substance in the pouch, and allows the pouch to be refrigerated during storage and throughout the pouch (ie, the pouch may remain uncooled). first to last dose released from it).

If desired, and as typically indicated in dashed lines in FIG. 7, a tamperproof cap 24 may be secured to the door flange 241 after filling with the needle therethrough, and thermally release the cap 235 to prevent removal of the cap or otherwise tamper with the cap without damage to cap 243. Cap 235 forms a fluid impermeable peripheral seal with port 237 in a manner known to those of ordinary skill in the art. In addition, the lid 243 may form a fluid-tight seal between the plug and the ambient atmosphere and in turn provide additional moisture and / or vapor transmission barrier between the plug and the ambient atmosphere. The lid 243 may be connected to the door. in any of a number of different shapes that are currently known or will be known thereafter, including by a joint connection, ultrasonic welding, adhesive, or otherwise.

As shown in FIG. 9, in an alternative embodiment, the cap 235 may be retained on port 237 by a cap 245 which is snap-fitted to port 237 to securely secure the cap to port. Cap 245 includes an inner flange 247 which engages a peripheral flange 249 with cap 235 to secure the cap to the door. Inner flange 247 defines a central opening 251 for receiving a central raised portion 253 of the cap 235 into a needle penetrable and thermally releasable portion of the plug. Lid 245 further defines a plurality of locking flanges 255 angularly spaced relative to each other below inner flange 247. Each lug flange 255 defines a narrow transverse configuration to allow lid 245 to be slidably mounted over door flange 237. 2390 and to form a snap fit in engagement with the underside of the door flange 237 to prevent the lid from being removed from the door. Preferably, when seated in place, the inner flange 247 applies a predetermined substantially compressive preload to the elastic flange 249 of the cap 235 to thereby form a fluid impermeable seal between the cap, the cap and the port. In addition, the inner peripheral edge 257 of the plug is configured in a manner known to those of ordinary skill in the art based on the teachings provided herein to engage the inner surfaces of the door 237 and form a fluid tight seal between them throughout the life and use of the pouch. Cap 245 includes a cap disc 259 which is received in a peripheral recess 261 formed in the upper side of inner flange 247 formed by the cap. Cap disc 259 defines an annular protrusion 263, and defines an annular recess 265 for receiving the cap annulant protrusion thereon and thereby securely holds the lid disc thereon. The cap disk 259 is secured to the cap after needle penetration and thermal release of the cap 253 to thereby prevent access to the cap and provide an additional barrier to prevent the transmission of moisture, steam, or gas through the cap. plug.

In FIGs. 10-13, another assembly embodying the present invention is indicated generally by reference numeral 310. Assembly 310 is similar in many respects to assembly 210 described above with respect to FIGs. 7 - 9, and thus similar reference numbers preceded by the number "3" instead of the number "2" are used to indicate similar elements. As shown in FIG. 10, the one-way valve assembly 312 includes a manually engageable plunger activator 315 for releasing substantially measured amounts of fluid from the pouch 322 (FIG. 14) defining a variable volume storage chamber 324 through the valve. Valve assembly 312 includes an integrated rigid tube 314 defining at an upward end thereof a mounting flange 317 for mounting the valve and tube assembly to a relatively rigid housing 325 containing flexible bag 322 therein (FIG. 14) Box 325 and pouch 322 may be the same or substantially similar to the box and pouch described above, or may be made of any of a number of different materials, and / or may take any of numerous different shapes and / or configurations that are currently known or will be later. Vaulted activator 315 is made of an elastomeric material that is flexible and can be manually engaged and pressed inward to operate the activator and thereby pump fluid from the variable volume storage chamber 324 through the one-way valve 312. As shown in FIG. 11, the one-way valve 312 includes a tab 317 extending inwardly from the activator 315, the valve housing 330 defining a compression chamber 332 to receive from the variable volume storage chamber 324 each discrete dosage or portion of fluid to be released, a relatively rigid valve base 334, and at least one flow opening 3336 extending through the valve housing 330 adjacent to the valve base 334 and coupled in fluid communication with the compression chamber 332. The unidirectional valve 312 additionally includes a valve cap 338 formed of an elastic material and including a cap base 340 mounted on the valve housing 330 and secured against axial movement thereon, and a valve part 342 thereon. valve base 334. Δ valve part342 and valve housing 330 form an interference fit between them. As can be seen, valve part 342 and valve base 334 define a normally closed valve opening or joint extending axially 344 between them. Valve part 342 is moved radially between a normally closed position, as shown, with valve part 342 engaging valve base 334, and an open position (not shown) with at least one segment of valve part 342. radially spaced from valve base 33 to connect valve port 344 in fluid communication with flow port 336 and thereby allow fluid to pass from compression chamber 332 to flow port 336 and through valve junction 344.

The one-way valve 312 also includes an inlet port 348 extending through the tube 314 and coupled in fluid communication with the variable volume storage chamber 324 (FIG. 12). The one-way valve 312 may be connected directly to the variable volume storage chamber 324 and then welded or otherwise sealed to the pouch 322 such as to prevent contaminants from entering the compression chamber or valve. Alternatively, the inlet passage 348 may be coupled to a flexible tube of the type shown, for example, in FIG. 2, and the flexible tube can in turn connect the valve 312 to the storage chamber 324. As can be seen, in its normally closed position, the tab 317 separates the pressure chamber 332 from the inlet passage 348 and Thus, during the downward stroke of the domed activator 315, as indicated by the arrow in FIG.11, the tab 317 prevents fluid in the compression chamber 332 from flowing backwardly back into the storage chamber. opening port 348 and variable volume storage chamber 324, and in turn allows the manually depressed activator to pressurize the fluid in the compression chamber sufficiently to exceed the valve opening pressure and to release it through the valve. Then, during the upward or downward stroke of the domed activator 315, the suction or vacuum force created in the compression chamber causes flap 317 to flex from the inlet opening, as indicated by the arrow in FIG. 11, thereby locating the decompression chamber 332 in fluid communication with the inlet passage 348 and allowing the next dose of fluid to flow into the compression chamber.

The valve assembly 312 may otherwise be constructed in accordance with the teachings of co-pending patent applications assigned to the same applicant, incorporated by reference above. According to such teachings, at least one of the valve base diameter D2 (as shown in FIG. 11, the valve base defines a gradually decreasing diameter when moving from the upward end toward the downward end of the valve base). valve), the degree of interference between the valve part 342 and the valve base 334, the predetermined radial thickness of the valve part 342, and a predetermined modulus of elasticity of the valve cap material 338, are selected to (1) define a predetermined valve opening pressure generated by pressure of the domed shaped actuator 315 which allows fluid to pass from the compression chamber 332 through the normally closed valve opening 344, and (2) hermetically sealing valve312 and preventing bacteria or other contaminants from entering through valve opening 344 and into normally closed passageway 348. In the illustrated embodiment of the present invention, each of the diameter of the valve base D2, the degree of interference between the valve part 342 and the valve base 334, the predetermined radial thickness of the valve part 342, and the modulus of elasticity. Predefined Valve Cap Material 338, are selected to (1) define a predetermined valve opening pressure generated by activator pressure 315 which allows a predetermined volume of fluid to flow from the reservoir 324 in chamber 332 through valve port 344, and (2) hermetically seal valve port 344 and prevent bacteria or other contaminants from entering the normally closed position.

Valve assembly 312 additionally includes a protective cap or protector 366 (not shown in FIG. 10) which extends annularly around the flexible valve cap 338, and extends axially from the valve datamp base 338 to a point adjacent to the valve release point, but axially spaced into it. Protector 366 is mounted to valve housing 330 and includes a peripheral flange 367 which compressively engages a corresponding peripheral flange 369 of the dome-shaped activator 315 to securely secure the activator to the valve housing, and includes a lower annular flange 371 which engages compressively in the valve cover cover base 340 to securely hold the valve cover to the valve housing.

The 312 one-way valve assembly operates as follows. The dome-shaped activator 315 is pressed downwards, such as by manual engagement, to pressurize and in turn displace a substantially predetermined volume of fluid located in the compression chamber332. The resulting fluid pressure in the compression chamber 33 causes the tab 317 to seal against the valve housing wall surrounding the inlet passage 348 to thereby prevent fluid communication between the inlet passage and the compression chamber. If desired, flap 317 and / or the wall surrounding the inlet passage 348 may be angled to assist in creating a seal between the flap and the wall. A substantially predetermined volume of fluid then moves from the compression chamber 332 through the flow port 336 at the valve base 334 and out through the valve port 344. When the activator 315 is depressed downwards, the chamber 332 is emptied or substantially emptied. When the user releases activator 315, a vacuum is created in chamber 332 and the tab swings out of passage 348, as indicated by the arrow in FIG. 11, which allows fluid to flow from reservoir 324 in compression chamber 332.

If desired, and as typically shown in FIG. 13, valve housing 330 may include an arm 319 which is spaced below and adjacent flap 317 a sufficient distance to define a gap 321 between the arm and the flap is located in the normally closed position.

The arm 319 operates as a stop to prevent further downward movement of the tab and thereby to prevent the overhang from being out of position. As shown, arm 319 may define one or more flow openings therethrough to allow fluid to flow freely when the flap is open. As shown in FIGs. 12, 13 and 14, the valve and pipe assembly may additionally include a radially spaced valve cap or housing 321 for forced pipe 314 to cover the pipe and, if desired, support the valve and pipe assembly against the housing 325 (FIG. 10).

As can be appreciated by those of skill in the art based upon the teachings provided herein, activator 315 and compression chamber 332 may take any of a number of different shapes and / or configurations, and / or may be formed of any of a number of different materials. are currently known, or will later be required to perform the functions of these components. For example, the compression chamber 332 may define a curvilinear shape to facilitate engagement between the lower part of the dome activator and the compression chamber in the downward stroke of the activator. Similarly, the underside of the activator may form a more traditional piston shape, such as a cylindrical protrusion, which is slidably received in a correspondingly formed compression chamber. In addition, the activator may include a lever or other operator that is manually engaging to depress the activator, and in turn release metered amounts or substantially metered quantities of fluids from the variable volume storage chamber and through the one-way valve.

In an alternative embodiment shown in FIG. 15, the variable volume storage chamber 324 is not defined by a box-mounted flexible pouch as defined above with respect to FIGs. 7-14, but preferably is defined by a relatively rigid tubular housing 322. A piston 325 is slidably mounted to the tubular housing 322 and forms a fluid impermeable seal between the peripheral surface of the piston and the inner wall of the piston. tube carcass. As can be seen, the variable volume storage chamber 324 is formed between the plunger 325 and the inlet passage 348 for the valve assembly 312. The tubular housing 322 includes an end cap 367 defined as a flow flow opening. fluid 369 in it to allow it to flow freely therethrough and thereby allow the piston 325 to slide into the tubular housing 322 by releasing fluid from the variable volume storage chamber 324. In this embodiment, the vacuum created in the chamber compression chamber 332 in the upward or return stroke of the dome-shaped activator 315 directs fluid from the variable volume storage chamber 324 and in turn causes the plunger 325 to move inwardly toward the inlet passage 348 and correspondingly. adjusts the volume of the storage chamber to compensate for fluid release.

The apparatus and methods for pre-sterilizing the sealed valve, tube, empty pouch assembly for mounting the plug to the bag or other container, and / or for aseptically filling the sterilized valve, tube and pocket assembly through the penetrable plugs and laser-releasable, may take the form of any of the apparatuses and methods described in the following patents and patent applications assigned to the same applicant which are hereby incorporated by reference as part of the present disclosure: U.S. Patent Application No. Seri-al 10 / 766,172 filed January 28, 2004, entitled "Medication Bottle Having a Hot-Sealable Cap, and Apparatus and Method for Filling the Bottle", which is a continuation in part of the Request for U.S. Patent similarly entitled Serial No. 10 / 694,364 filed October 27, 2003, which is a continuation of the similarly co-pending U.S. Patent Application. entitled No. Serial 09 / 781,846 filed February 12, 2001, now U.S. Patent No. 6,604,561, issued August 12, 2003, which in turn claims the similarly entitled United States Provisional Application. Serial 60 / 182,139 filed February 11, 2000 and U.S. Provisional Patent Application No. 60 / 443,526 filed January 28, 2003; and U.S. Provisional Patent Application similarly titledNo. 60 / 484,204 filed June 30, 2003; U.S. Patent Application No. 10 / 655,455, entitled "Sealed Containers and Methods of Manufacturing and Filling", filed September 3, 2003, which in turn claims the benefit of the Patent Application. Provisional Court similarly titled No. 60 / 408,068 filed September 3, 2002; U.S. Provisional Patent Application No. 60 / 551,565 filed March 8, 2004, entitled "Apparatus and Method for Buffer Molding and Mounting"; U.S. Patent Application No. 10 / 600,525 filed June 19, 2003 entitled "Sterile Filling Machine Having Electron Beam Chamber Needle Filling Station" which in turn claims the benefit of the US Provisional Patent Application. American similarly titled No. 60 / 390,212 deposited June 19, 2002; U.S. Patent Application No. 10 / 983,178 filed November 5, 2004 entitled "Laser Filling and Needle Filling Station", which in turn claims the benefit of the similarly filed U.S. Provisional Patent Application. No. 60 / 518,267 filed November 7, 2003 and similarly filed US Provisional Patent Application No. 60 / 518,685 filed November 10, 2003; U.S. Patent Application No. 60 / 550,805 filed March 5, 2004 entitled "Laser Release Needle Prefilling Apparatus"; and U.S. Patent Application No. 08 / 424,932 filed April 11, 1995, now U.S. Patent No. 5,641,004, issued June 24, 1997 entitled "Process for Filling a Receptacle Sealed Under Aseptic Conditions ".

In the presently preferred embodiments of the present invention, each releasable plug is formed of a thermoplastic material defining a needle penetration region that is pierceable with a needle to form a needle opening therethrough, and is releasable. hot to hermetically seal the needle aperture by applying alaser radiation at a predetermined wavelength and energy therein. Each plug includes a thermoplastic shell defining (i) a predetermined wall thickness in an axial direction thereof, (ii) a predetermined color and opacity that substantially absorbs laser radiation at the predetermined wavelength and substantially prevents radiation from passing through. through the predetermined wall thickness, and (iii) a predetermined color and opacity that causes laser radiation at the predetermined wavelength and energy to hermetically seal the needle aperture forming the needle penetration region in a period of time. predetermined time and substantially without burning the needle penetration region and / or the cover portion of the cap (i.e. without creating an irreversible change in the molecular structure or chemical properties of the material). In some embodiments, the predetermined time period is approximately 2 seconds, preferably less than or equal to approximately 1 second. In some of these embodiments, the predetermined laser radiation wavelength is approximately 980 nm, and the predetermined cadalaser energy is preferably less than approximately 30 Watt, and preferably less than or equal to approximately 10 Watts, or in the range of approximately 8 Watt. at about 10 Watts. Also, in some of these embodiments, the predetermined color of the material is gray, and the predetermined opacity is defined by a dark gray dye (or pigment) added to the buffer material in a range of from about 0.3% to about 0.6% dope.

In addition, if desired, a lubricant of a type known to those skilled in the relevant art may be added to or included in each of the aforementioned thermoplastic compounds to prevent or otherwise reduce particle formation by penetrating the penetration region. of the thermoplastic part with the needle. In one embodiment, the lubricant is a mineral oil which is added to the styrene block copolymer or other thermoplastic compound in an amount sufficient to prevent, or substantially prevent, the formation of departments by penetrating it with the needle or other filler member. In another embodiment, the lubricant is a silicone, such as liquid silicone sold by Dow Corning Corporation under the brand name "360 Medical Fluid, 350 CST", or a silicone oil, which is added to styrene block polymer or other compound. thermoplastic in an amount sufficient to prevent, or substantially prevent, particle formation by sieving it with the needle or other filler member. In such an embodiment, the silicone oil is included in an amount ranging from about 0.4% to about 1% by weight, and preferably in the range of about 0.4 to about 0.6% by weight. and most preferably in the range of about 0.51 or about 0.5% by weight.

As described above, the needle configuration that is penetrating the plug, the frictional forces created on the needle / plug interface, and / or the needle travel through the plug may also be controlled to further reduce or substantially prevent the formation of particles by penetrating the plugs with the needles.

Also according to a presently preferred embodiment, the porlaser releasable needle penetrable buffer comprises: (i) a styrene block copolymer, such as any such styrene block copolymers described above, in the range of approximately 80% to approximately 97%. wt% (e.g. 95 wt% as described above); (ii) an olefin, such as any of the ethylene alpha olefins, polyolefins or olefins described above, in the range of approximately 3% to approximately 20% dope (e.g., approximately 5% as described above); a sufficiently added pigment or colorant to absorb laser energy, convert radiation to heat, and melt the buffer material, preferably to a depth of at least about 1/3 to about H of depth. from the orifice of the needle in a time period of less than approximately 3 seconds, more preferably less than approximately 1 - 1/2 seconds, and more preferably less than approximately 2 seconds; and (iv) a lubricant, such as a mineral oil, liquid silicone, or silicone oil as described above, added in an amount sufficient to substantially reduce the frictional forces on the inter-needle / plug during needle penetration of the plug by itself. rather substantially prevent particle formation.

In one embodiment of the invention, the pigment is sold under the brand name Lumogem ™ IR 788 by BASF Aktiengesellschaftde Ludwigshafen, Germany. Lumogen IR products are highly transparent selective infrared absorbers designed to absorb radiation from semiconductor lasers with wavelengths close to 800 nm. In this mode, the Lumogen pigment is added to the elastomeric mixture in an amount sufficient to convert the radiation to heat, and to melt the buffer material, preferably to a depth of at least about 1/3 to approximately Ή the depth of the orifice of the needle over a time period of less than approximately 3 seconds, more preferably less than approximately 1 second, and more preferably less than approximately H second. The Lumogen IR 788 pigment is highly absorbent at approximately 788 nm, and therefore, in conjunction with this embodiment, the laser preferably transmits radiation at approximately 788 nm (or approximately 800 nm). An advantage of Lumogen IR 788 pigment is that very small amounts of this pigment may be added to the elastomeric mixture to achieve release by Ia-ser at the desired or otherwise desired time and depth of release, and therefore desired. Thus, the needle-penetrable, laser-releasable plug may be transparent or substantially transparent. This can be a significant aesthetic advantage. In one embodiment of the invention, the Lumogen IR 788 pigment is added to the elastomeric mixture at a concentration of less than about 150 ppm, is preferably in the range of from about 10 ppm to approximately 100 ppm, and more preferably. is in the range of about 20 ppm to about 80 ppm. In this embodiment, the 800 nm laser energized level is preferably less than approximately 30 Watts, or in the range of approximately 8 Watts to approximately 18 Watts.

Also according to a presently preferred embodiment, in addition to controlling one or more of the above mentioned parameters to reduce and / or eliminate particle formation (i.e. including silicone oil or other lubricant in the thermoplastic compound, and controlling the confi- needle friction, the degree of friction at the needle / plug interface, and / or the needle stroke through the plug), the differential elongation of the releasable buffer thermoplastic components is selected to reduce and / or eliminate particle deformation.

Thus, according to such an embodiment, the laser-release needle penetrable plug comprises: (i) a first thermoplastic material in the range of from about 80% to about 97% by weight and defining a first elongation; (ii) a second thermoplastic material in the band about 3% to about 20% by weight and defining a second elongation less than the elongation of the first material; (iii) a pigment or colorant is added to an amount sufficient to absorb the energy to be, convert the radiation to heat, and melt the buffer material, preferably to a depth of at least about 1/3 to approximately the depth of the water. needle orifice in a shorter time than approximately 2 seconds, more preferably less than approximately 1.5 seconds, and more preferably less than approximately 1 second; and (iv) a lubricant, such as a mineral oil, liquid silicone, or silicone oil as described above, added in an amount sufficient to substantially reduce forces of needle / buffer interface atritone during tampon needle penetration to, for example, in turn substantially prevent particle formation.

According to a further aspect, a first material defines a lower melting point (or Vicat softening temperature) than that of the second material. In some embodiments, the first material is a styrene block copolymer, and the second material is an olefin, such as any of a variety of ethylene alpha olefins or polyolefins. Also according to a presently preferred embodiment, the first material defines an elongation of at least about 75% by force of 10 lbs (i.e., the length increases by approximately 75% when subjected to a force of 10 lbs), preferably at least 85%, and most preferably at least 90%; and the second material defines an elongation of at least about 5% by force of 10 lbs, preferably at least about 10%, and more preferably at least about 15%, or in the range of about 15%. and approximately 25%.

In FIGs. 16 - 18, another assembly embodying the present invention is indicated generally by reference numeral 410. Assembly 410 is similar in many respects to assemblies 210 and 310 described above with respect to FIGs. 7-15, and therefore, numerals. Similar reference numbers preceded by the number "4" instead of the numbers "2" or "3" are used to indicate similar elements. Variable volume storage chamber 424 is defined by a flexible pouch 422 received in a relatively rigid box or other suitably container 425. A tube 414 defining an inlet passage 448 is coupled in fluid communication between the variable volume storage chamber 424 and compression chamber 432. A substantially elastic vault-shaped actuator or pump 415 defines on its internal side a compression chamber valve member 417 that forms a tapered transverse configuration that inwards toward the free end of the valve member. In the downward stroke of the dome-shaped activator 415, as indicated by the arrow in FIG. 16, the free end of the compression chamber valve member 417 is received in the inlet passage 448 of the tube 414 to prevent any additional fluid from flowing from the storage chamber 424 in the compression chamber 432 and in turn to sufficiently pressurize with additional hand compression of the dome-shaped activator 415 the fluid in the compression chamber 432 to override the opening pressure of the valve and to release a substantially predetermined amount of fluid through the one-way valve 412. In the return or upward stroke of the dome activator 415, the free end of the valve member 417 is pushed up and out of the inlet passage 448 of tube 414 to in turn locate the compression chamber 432 in communication. with the variable volume storage chamber 424 and thereby allow fluid to flow from the storage chamber 424 into the storage chamber. 432. The pouch 422 is sufficiently flexible to decrease in internal volume by an amount corresponding to the amount of fluid flowing from the storage chamber 424 in the compression chamber 432 in the return stroke of the shaped activator. of vault415. Preferably, the dome-shaped activator 415 is configured to retain sufficient spring force when pressed inwardly downwardly to push it up and back to the ready position as typically shown in FIG. 16 when manually released.

The one-way valve assembly 412 includes a valve housing 430 defining an axially extending valve base 434, and an elongated flow opening 436 formed in valve housing 430 and extending in fluid communication between the compression chamber. 432 and the valve seat 434. The one-way valve assembly 412 additionally includes a valve cap 438 formed of elastic material and integrated with the dome-shaped activator 415. Valve cap 438 includes a mounted cap base 440 in the valve housing 430 and securely secured against such movement by a flange 467 of a relatively rigid locking ring 467, and a valve portion 442 on the valve base 434. As shown in FIG. 18, valve portion 442 is arcuate in shape when viewed in a plane perpendicular to the elongate axis "X" of the assembly, and as typically shown in FIG. 16, when viewed in a plane of the elongate axis X, valve portion 442 defines a substantially conical transverse configuration that narrows inwardly when moving inward from the valve (or from the base toward the tip of the valve). valve release). Valve portion 442 defines a predetermined radial thickness that is progressively thinner when moving inwardly toward the outside of the valve (or from the base toward the deliberate tip of the valve). As shown in FIG. 16, the inner surface of the valve cap 442 is defined by a first variable radius R1 which progressively increases in magnitude as it moves toward the base toward the release point of the valve cap, and the outer surface of the valve base. Valve 434 is defined by a second variable radius R2 which equally progressively increases in magnitude as it moves toward the base to the valve base release tip. Similar to the one-way valves described above, for each engaged valve cover segment and valve base, R2 is larger than R1 to thereby form an interference fit between the valve cover and the valve base. Consequently, as with the one-way valves described above, the flexible valve portion 442 and valve base 434 cooperate to define a normally closed valve or junction opening extending axially 444 therebetween. Also like the one-way valves described above, the valve part 442 is moved radially between a normally closed position as shown in FIG. 16, with the valve part 442 engaging the valve base 434, and an open position (not shown) with at least A segment of the radially spaced valve portion 442 of the valve seat 434 to connect the valve opening 444 in fluid communication with the flow opening 436 to desemode fluid to flow from the flow opening 436 through the valve opening 444. As typically shown in FIG. 18, valve portion 442 is substantially semicircular when viewed in a plane perpendicular to the elongate axis X of the assembly. As indicated in FIG. 16, valve base 434 corresponds in shape and extends to valve side 442 to thereby form the normally closed valve opening or junction extending axially444 therebetween. As may be appreciated by those skilled in the relevant art based on the teachings herein, the shape of the valve base and valve part, including the arcuate extent of each such component, may vary from that shown herein as desired. or otherwise dictated by applying the set and desired performance characteristics. As shown in FIG. 17, snap ring 466 includes opposing snap flanges 469 which engage corresponding side portions of the valve base 434 to securely hold the snap ring to the valve base, and in turn securely retain the valve cap and valve apart between them. As shown in FIG. 16, the tube 414 is formed integrated at one end thereof with a base wall 471 of the compression chamber 432, and is formed integrated in another end thereof with a flange 473 fixedly secured to the pouch 422. The base wall 471 of the compression chamber 432 It is received in an opening 475 of the container 425, and includes a peripheral flange 477 sealingly engaged in an annular recess 479 of the container. Snap ring 466 defines a peripheral snap flange 481 which engages the lower portion of a peripheral flange 483 of container 425 to compress peripheral flange 469 and cap base 440 between the snap ring and container flange. in a substantially predetermined pre-charge to prevent any leakage for the entire life and use of the assembly, thereby securely holding the integral mounted dome-shaped activator and valve cover, valve and tube assembly, and container together.

In operating the 410 assembly, a user releases a substantially predetermined amount of fluid through the one-way valve 412 by manually engaging the dome-shaped actuator 415 with, for example, one or more fingers or the palm of the hand. press down. At the downward or inner side of the activator, the valve end free end of the compression chamber 417 is received in the outlet port 448 of the tube 414 to thereby block the flow of any fluid between the compression chamber 432 and the storage chamber 424. Then, at As the dome activator 415 is further depressed, the flow in the compression chamber 432 is sufficiently pressurized to exceed the opening pressure of the one-way valve 412 and in turn to open the valve and release subs. - Mostly all fluid in the compression chamber through the valve. The user then removes his or her hand from the dome-shaped activator 415, and the spring force inherent in it activates the activator to return to its original shape or position as shown in FIG. 16. As the dome-shaped activator 415 returns to its ready position, the free end of the compression chamber valve member 417 is removed from inlet passage 448 which in turn allows fluid to be directed to above from the storage chamber into the compression chamber due to vacuum or suction created in the compression chamber in the upward stroke of the activator. When it returns to its original position, the compression chamber 432 is filled with fluid and the assembly is ready to release another predetermined volume of fluid. Although not shown, housing 425 may define at least one opening to allow air to flow into the space between pouch 422 and housing 425 to facilitate the ability of the pouch to bend inward as fluid is released from it.

As may be appreciated by those of skill in the art based upon the teachings provided herein, the dome-shaped pouch or activator may include a needle-penetrable or laser-releasable plug to needle-fill the variable-volume storage chamber and release by laser. the resulting needle orifice as described above. The pouch 422 and the box 425 may be made of the same materials as the pouch and box described above, respectively, or may be made of any of the numerous other materials that are currently known, or will be thereafter. For example, the housing 425 may be made of plastic, such as by blow molding or thermosetting. In addition, the one-way valve 412 may define a configuration that is the same or more similar to any of the one-way valves described above in conjunction with the other embodiments.

In FIG. 19, another apparatus incorporating this invention is indicated generally by reference numeral 510. Apparatus 510 is similar in many respects to the various embodiments described above, and thus similar reference numbers preceded by the numeral "5". ", or preceded by the number" 5 "instead of another number, are used to indicate similar elements. The primary difference from the apparatus 510 compared to the apparatus described above is that the apparatus 510 includes an expandable bladder or pouch 522 mounted in a relatively rigid container 528 and defining a variable volume storage chamber 524 between them for storing the apparatus. fluid to be released. Preferably, the fluid is stored in chamber 524 in a hermetically sealed, substantially airtight condition for the entire life and use of the apparatus (i.e., throughout the release of multiple doses or parts of the product from the apparatus. ). An inlet port 525 is coupled in fluid communication between an inner chamber 527 of the expandable bladder 522 to allow air or other gas to flow into the chamber 527 to in turn allow the bladder 522 to expand outwardly. by releasing fluid from the variable volume storage chamber 524 and via the one-way valve assembly 512. In one embodiment, the expandable bladder 522 is inherently elastic and angled outward to expand outward upon release. fluid from the variable volume storage chamber 524. In another embodiment, the apparatus includes an inlet valve 529 coupled in fluid communication between the interior chamber 527 of the bag and the ambient atmosphere and / or a gas source. (not shown) to control the flow of air or other gas into the inner chamber 527. In such an embodiment, the pressurized gas is introduced through the inlet valve 529 and into the inner chamber. 527 to pressurize the expandable bladder 522 outward and in turn pressurize the fluid in the variable volume storage chamber 524 to facilitate fluid release through the one-way valve assembly 512. In the illustrated embodiment, the apparatus in It includes a manually engageable activator 515 to pump metered or fluid doses through the valve assembly 512. However, as can be recognized by those versed in the relevant technique based on the learned teachings, any of the numerous manually different pumps engaging, pedal-activated, electrically-activated, or electro-mechanically-activated locks that are currently known, or will later be, can also be nailed.In FIG. 20, another apparatus embodying the present invention is indicated generally by reference numeral 610. Apparatus 610 is similar in many respects to the various embodiments described above, and thus similar reference numbers preceded by the numeral "6". ", or preceded by the number" 6 "instead of another number, are used to indicate similar elements. The primary difference from the apparatus 610 compared to the apparatus described above is that the apparatus 610 does not include a bladder or flexible pouch defining a variable volume storage chamber, but preferably the storage chamber 624 is defined by the interior of the container 62 8. A sterilization filter 631 is mounted in the container 628 and coupled in fluid communication between the storage chamber 624 and the ambient atmosphere to allow air or other gas to flow into the storage chamber and sterilize the air or another gas by passing it through the filter to thereby keep the fluid in the container in an aseptic condition. The filter 631 can take the form of any of the numerous different filters that are currently known, or will later be performed to perform the function of the filter 631, including a microbicidal filter. Such a filter defines a pore size of less than 10 microns, preferably less than 5 microns, and more preferably less than or equal to approximately 2 microns. The container 628 may be rigid, semi-rigid, or flexible, and may be made of any of a number of different materials, or may be formed in any of a number of different shapes or configurations, which are presently known or to be thereafter. In the illustrated embodiment, the apparatus includes a manually engaging activator 615 for pumping measured parts or doses of fluid through valve assembly 612. However, as may be appreciated by those skilled in the relevant art based on the teachings provided herein, any Of the number of different manually engaging, pedal-activated, electrically activated, or electro-mechanically activated pumps that are currently known, or to be later, may also be employed.

In FIG. 21, another apparatus embodying the present invention is indicated generally by reference numeral 710. Apparatus 710 is similar in many respects to the various embodiments described above, and thus similar reference numbers preceded by the numeral "7". ", or preceded by the number" 7 "instead of another number, are used to indicate similar elements. As with various embodiments described above, apparatus 710 includes a flexible pouch 722 defining a variable volume storage chamber 724, a one-way valve assembly 712, and a flexible tubing 714 coupled in fluid communication between the one-way valve and the storage chamber. An inlet valve 729 is mounted on the container 728 and is fluidly connectable between a pressurized fluid source, such as air or other gas, and the inner chamber 727 formed between the flexible bag 722 and the relatively rigid container 728. In one embodiment, the pressure source 733 introduces pressurized air or other gas into the chamber 727 to in turn pressurize the pouch 722 and the contained fluid product. A valve 715 of a type known to those of skill in the relevant art is movable between (i) a closed position where it squeezes the flexible tube 714 into a closed position to prevent fluid from passing therethrough, and (ii) an open position in the which releases the flexible tube 714 and allows fluid to pass through it. In the open position, pressurized gas in chamber 727 creates sufficient pressure to move fluid product through the one-way valve712. The valve 715 may be manually engageable to open and close the valve, or may be electrically or electro-mechanically activated between the open and closed position. In one embodiment, the container is initially filled with pressurized gas, and this amount of pressurized gas is sufficient to release the entire fluid product through the valve. In another embodiment, the pressure source 733 may take the form of a pump that pumps pressurized air or other gas into chamber 727 to release product through the one-way valve. In this embodiment, valve 715 can be deleted and pump 733 can be activated to release fluid through the valve. Also in this embodiment, the pump 733 can take the form of any of the numerous different manually engaging, pedal activated, electrically activated, or electro-mechanically activated pumps that are currently known or will be thereafter.

In FIG. 22, another apparatus employing the present invention is indicated generally by reference numeral 810. Apparatus 810 is similar in many respects to various embodiments described above, and thus similar reference numbers preceded by the number "8", or preceded by the number "8" rather than another number, are used to indicate similar elements. As with various embodiments described above, apparatus 810 includes a flexible pouch 822 defining a variable volume storage chamber 824, a one-way valve assembly 812, and a flexible tubing 814 coupled in fluid communication between the one-way valve and the storage chamber. Apparatus 810 comprises a manually actuated peristaltic pump 815 mounted adjacent and engageable with flexible tube 814 to pump metered portions or doses of fluid product from variable volume storage chamber 824 through tube 814 and one-way valve assembly 812.

In the illustrated embodiment, the pump 815 is manually activated or pedal activated, and comprises a pivotally mounted peristaltic pumping member 835 including a plurality of rollers 837 mounted around the periphery to pivotably engage the hose 814 and compress it to, for example. In turn, pump the fluid product through it. A rigid curvilinear pump block 839 is mounted on the opposite side of hose 814 relative to peristaltic pumping member 835 to allow rollers 837 to compress hose 814 against the block and pump fluid product therethrough. . A connection assembly 841, such as the multi-bar connection, is connected to the peristaltic pumping member 835 to pivot the pumping member. A manually engaging lever or foot pedal (not shown) is operably connected to port 841 to actuate the port and in turn pivotably engages peristaltic pumping member 835 to pump metered portions of fluid product from the storage chamber. variable volume 824 through the one-way valve assembly 812. The flexible pouch, tube and valve assembly are provided in a disposable form such that they are disposed of when empty; however, container 810 and pump 815 do not normally touch the fluid product and therefore may be reused with numerous different bags, tubes and valve assemblies, or may also be provided in disposable form.

In FIG. 23, another apparatus employing the present invention is indicated generally by reference numeral 910. Apparatus 910 is similar in many respects to various modalities described above, and thus similar reference numbers preceded by the number "9", or preceded by the number "9" rather than another number, are used to indicate similar elements. As with various embodiments described above, apparatus 910 includes a flexible pouch 922 defining a variable volume storage chamber 924, a one-way valve assembly 912, and a flexible tubing 914 coupled in fluid communication between the one-way valve and the storage chamber. In the illustrated embodiment, the pump 915 is manually activated or activated by the pedal, and comprises the pump block 939 mounted on one side of the flexible tube 914, and an oscillating arm 935 pivotally mounted on the opposite side of the flexible tube. indicated by the arrow and dashed lines in the drawing, the oscillating frame is manually activated downward in the drawing to engage the flexible tube 914 and in turn compress the tube to pump measured parts or doses of the fluid flow through it. Swingarm 935 may be manually self-engaging, or a manually engageable lever or other activator may be coupled to the swiveling arm to move it in the manner indicated and in turn pump measured portions of fluid product through the one-way valve. . The flexible bag, tube and valve assembly are provided in a disposable form such that they are discharged when emptied; however, the container 910 and pump 915 do not normally touch the fluid product and therefore may be reused with numerous different bags, tubes and valve assemblies, or may also be provided in disposable form.

An advantage of the present invention is that the same product may remain stable in the pouch, if refrigerated or otherwise, for the entire life and use of the pouch. Accordingly, the present invention is particularly suited for storing and releasing ready-to-drink products, including non-acidic products, such as those which are generally difficult to preserve upon opening the package, including without limitation, beverages such as wine, beverages containing milk, cocoa-based drinks, malt-based drinks, tea, coffee, coffee concentrate, tea concentrate, other concentrates to make beverage or food products, sauces, such as cheese and milk, or meat sauces, sauces meat, soups, nutritional supplements, meal replacements, baby formulas, milks, growing milks, etc. Accordingly, a significant advantage of the presently preferred modes of the present invention is that they allow the above mentioned products and any of the numerous other products to be distributed and stored at room temperature and allow the product to remain stable even after releasing the product from the product. bol-sa, whether refrigerated or not. However, for certain products, it may be desirable to refrigerate the product to provide a better taste, to provide the product at a desired or standard temperature, or for any of the numerous reasons that are currently known or will be thereafter.

This patent application contains subject matter relating to that US Patent Application Serial No. 11 / 295,274, filed December 5, 2005, entitled "One-Way Valve and Apparatus Using The Same", US Patent Application Serial No. 11 / 295,251 filed December 5, 2005, entitled "Method of Use of One-Way Valve and Related Apparatus", U.S. Provisional Patent Application No. 60 / 633,332 filed December 4, 2004, U.S. Provisional Patent Application No. 60 / 644,130, filed on January 14, 2005, both of which are entitled "One-way Valve, Apparatus and Method of Use"; U.S. Provisional Patent Application No. 60 / 757,161 filed January 5, 2006, and U.S. Provisional Patent Application No. 60 / 843,131 filed September 9, 2006, both of which are entitled " Unidirectional Valve Apparatus and Method of Use ". Each of the foregoing patent applications is incorporated herein by reference as part of the present disclosure.

As may be appreciated by those of skill in the art based upon the teachings provided herein, numerous changes and modifications may be made to the embodiments described above and others of the present invention without departing from the spirit of the invention as defined in the claims. For example, the components of the apparatus may be made of numerous different materials which are currently recognized or will later be performed to perform the function (s) of each such component. Similarly, the apparatus components may take any of numerous different forms and / or configurations, additional components may be added, components may be combined, and one or more components or features may be removed.

In addition, the apparatus may be used to release any of the numerous different types of fluids or other substances into any of the numerous different applications, including, for example, nutritional, food, beverage, hospital, bio-pharmaceutical, dehydrating processing and pharmaceuticals. For example, the dispenser may take the form of a self-tinted food or beverage dispenser of the type described in U.S. Patent Application No. 10 / 328,826 filed December 24, 2002, entitled "Automated Internal Food or Beverage Dispenser" "(Publication No. US 2004/0118291 Al), or U.S. Patent Application Serial No. 10 / 83,110, filed April 28, 2004 entitled" Automated Internal Food or Beverage Dispenser "(Publication No. US 2004/0194811 A1), each of which is expressly incorporated herein by reference as part of the present disclosure. In this exemplified application, the one-way valve and pipe assembly described herein replaces the pipe and compression valve coupled between the reservoir and the manifold. Alternatively, the one-way valve assembly, tube and pouch described herein replace each tube and associated compression valve and reservoir described in such patent applications. A significant advantage of this application is that the one-way valve substantially prevents any microorganisms from entering the reservoir which may contain a milk-based product, and furthermore allows it to be released at room temperature without require container cooling. In addition, the one-way valve, tube and pouch assembly may be used to store any of the numerous different release products, such as milk products, including milk concentrate, half milk and half cream, and others. baby creams, food or formulas, decreasing milk, other liquid nutrition products, coffee, coffee concentrate, tea, tea concentrate, syrup, such as hot chocolate chocolate syrup, decappuccino syrups, or other mixtures or syrups, flavoring coffee to give off a "fresh" coffee aroma on the spot, or especially when it comes to releasing coffee, or other everyday products such as yogurt and ice cream, or non-daily products such as juices, coffee products soy, supplemental nutritional drinks, functional food products, mixed drinks, or meal replacement drinks.

In addition, the filling machines used to fill the reservoirs used with the apparatus of the present invention may take any of the numerous different configurations that are currently known, or which will subsequently be known to fill the reservoirs, pouches or dispensers. For example, filling machines may have any of a number of different mechanisms for sterilizing, filling, evacuating and / or filling the one-way valve, tube and bag, or otherwise filling the reservoirs. In addition, instead of using the laser penetrable needle-penetrable plug, the reservoir may employ a fill valve as described in the following patent application which is assigned to the Applicant of the present invention, and is incorporated herein. for reference as part of the present description: U.S. Application Serial No. 10 / 83,902 filed May 12, 2004 entitled "Doser and Apparatus and Method for Filling a Doser". In such alternative embodiments, the inflating valve may extend through the pouch or otherwise may be coupled in fluid communication with the storage chamber to evacuate and / or fill it. Alternatively, the reservoir may include a one-way valve to evacuate the interior of the reservoir and another valve to fill the reservoir storage chamber. In addition, any of the numerous different types of bag filling machines and / or methods currently known, or to be known later, may be used. Still further, the pump and / or release valve may have a configuration which is different from that described herein. For example, the bomb may take the form of any of the numerous different bombs that are currently known, or will be later.

For example, the pump may include a piston that is movable in a plunger chamber connectable in fluid communication such as pipe and / or the variable volume storage chamber, a manually engaging portion for moving the piston and in turn pumping the substance. from the variable volume storage chamber through the one-way valve. Alternatively, instead of a vaulted member, the pump can define an elastic compression bulb that is manually compressed to release a substantially measured volume of fluid. from the variable volume storage chamber and through the one-way valve, or you can define a different type of manually engaging activator and a different type of spring, such as a coil spring, or an elastic spring, which creates sufficient force. demolishes in a downward stroke of the manually engaging activator to return the activator to its ready position when released by the user. Alternatively, the pump may include a lever coupled to a piston or dome-shaped member to release fluids through the valve, or may include another type of manually engaging or pedal member that is currently known or will be thereafter. Consequently, this detailed description of presently preferred embodiments is taken in an illustrative sense, as opposed to a limiting one.

Claims (25)

1. Valve and flexible bag assembly for aseptically storing a substance, releasing multiple parts of the stored substance, and keeping the remaining substance in the bag in a sealed aseptic condition with respect to the ambient atmosphere, the valve assembly and the bag The flexible hose can be received in a relatively rigid housing and adapted to cooperate with a pump to pump discrete parts of substance from the pouch and through a one-way valve to release the substance from it, FEATURED by the fact that comprising: a flexible pouch defining therein a sealed variable volume storage chamber with respect to the ambient atmosphere for aseptically storing multiple parts of the substance; a one-way valve including a valve housing defining an axially extending valve base and at least one flow opening extending through the valve housing and / or valve base; and a valve cap mounted on the valve housing and comprising an axially extending portion formed of an elastic material covering the valve base and covering a substantially axially extending portion thereof, wherein the valve portion defines a predetermined radial thickness and forms an interference fit with the valve base, the valve part and the valve base define a joint extending axially between them forming a normally closed valve opening extending axially, and the valve part is moved radially between (i) a position normally closed with the valve part engaged with the valve base, and (ii) an open position with at least one valve portion radially spaced from the valve base to connect the valve port in fluid communication with minus a valve port. flow and thereby allow passage of substance from the variable volume storage of the valve opening, where in normally closed and open positions, the one-way valve holds the remaining substance in the variable volume storage chamber in an aseptic and sealed condition with respect to the ambient atmosphere. An assembly according to claim 1, characterized in that the flexible pouch defines an aseptic, empty and sealed storage chamber adapted to receive a substance to be stored and released therefrom. An assembly according to claim 1, characterized in that the flexible pouch is aseptically shaped fill with a substance that is at least one between a food and a drink. Assembly according to Claim 3, characterized in that the substance is selected from the group including a milk product, Ie te, evaporated milk, condensed milk, cream, half milk cream, formula for baby, growing milk, yogurt, soup, ice cream, juice, syrup, coffee, condiments, ket-chup, mustard, mayonnaise, and coffee aroma. An assembly according to claim 1, further characterized by the fact that it comprises a flexible hose coupled in fluid communication between the bag and the one-way valve. Assembly according to Claim 5, characterized in that the hose is connected to the hose and the one-way valve by at least one of (i) an adjustment fitted to at least one of the flexible bag and the one-way valve that engages. by friction at a respective end of the pipe to form an airtight seal therebetween, (ii) a heat seal, (iii) a weld, and (iv) an adhesive. An assembly according to claim 1, characterized in that the pouch is formed of a plastic laminate which includes an oxygen / water barrier and an approved food contact layer. Assembly in combination with a dispenser according to claim 1, characterized in that the doser comprises a relatively rigid container receiving the flexible pouch, and a surface to support and position the one-way valve to release substances from this and another container. Assembly and dispenser according to Claim 8, characterized in that the dispenser additionally includes a pump operably coupled between the variable volume storage chamber and the one-way valve, and a unit control valve electrically coupled to the pump to control pump operation and in turn control the release of substance into the variable volume storage chamber through the one-way valve and the other container. Set and dispenser according to claim 9, characterized by the fact that the dispenser includes at least one pouch, and at least one pouch includes at least one of coffee, coffee concentrate, milk, milk product. milk, half milk and half cream, and cream. Assembly and dispenser according to Claim 10, characterized in that the dispenser includes at least one coffee aroma-containing pouch. An assembly according to claim 1, further characterized by the fact that it includes an electric actuator coupled in fluid communication between pockets and the one-way valve and manually moved to pump substance from the variable volume storage chamber through the valve. one way. Assembly according to Claim 12, characterized in that the electric activator is approximately dome-shaped. An assembly according to claim 13, further characterized by the fact that it comprises a manually engaged operator which is manually engaged to press the electrical activator and in turn to release substance from the variable volume storage chamber. through the one-way valve. Assembly according to Claim 14, characterized in that the manually engaged operator is a lever. An assembly according to claim 14, further characterized by the fact that it comprises a relatively rigid container receiving the flexible pouch. An assembly according to claim 16, characterized in that the relatively rigid container is made of either cardboard or plastic. 18. Valve and flexible bag assembly for aseptically storing a substance, releasing multiple parts of the stored substance, and keeping the remaining substance in the bag in a sealed aseptic condition with respect to the ambient atmosphere, the valve assembly and the bag The flexible hose can be received in a relatively rigid housing and adapted to cooperate with a pump to pump discrete parts of substance from the pouch and through a one-way valve to release the substance from it, FEATURED by the fact that comprising: first device herein defining a flexible variable volume storage chamber sealed with respect to the ambient atmosphere for aseptically storing multiple parts of the substance; second device to allow substance from the variable-volume storage chamber to be released therethrough, and to maintain the remaining substance in the variable-volume storage chamber in an aseptic condition and sealed from the ambient atmosphere during and after release. the substance from it; wherein the second device includes the third device for forming an axially extending valve base and at least one flow opening, and the fourth device mounted on the third device and including an axially extending elastic portion covering the third device and covering a substantial portion of it extending axially, defining a predetermined radial thickness and forming an interference fit with the third device, and defining an axially extending junction between the third and fourth device to form a valve opening normally. axially extending closed position and to move radially between (i) a normally closed position with the fourth device engaged with the third device, and (ii) an open position with at least one segment of the radially spaced fourth device of the third device to connect the valve port in fluid communication with at least one flow port thereby permitting the passage of substance from the variable volume storage chamber through the valve opening, and to maintain the remaining substance in the variable volume storage chamber in an aseptic and sealed condition with respect to the ambient atmosphere in the normally closed and open positions. . An assembly according to claim 18, characterized in that the variable-volume storage chamber contains a milk-based product, and the second device is to substantially prevent microorganisms from entering the storage chamber. variable volume and to allow the milk product to be stored and released without refrigeration. An assembly according to claim 18, characterized in that the first device is a flexible bag, the second device is a one-way valve, the third device is a valve housing and the fourth device is a flexible valve cap. . 21. Method for storing fluid and releasing multiple parts of the stored fluid, characterized in that it comprises the following steps: (1) providing a storage chamber and storing multiple parts of the fluid therein in an aseptic condition; (2) providing a one-way valve assembly which includes (i) a valve housing defining a valve base and a flow opening extending through at least one of the valve housing and valve base; and (ii) a valve cap formed of an elastic material which includes a valve part covering the valve base, wherein the valve part defines a predetermined radial thickness and forms an interference fit with the valve base, the valve part. and the valve base define a normally closed valve opening extending axially therebetween, and the valve part is moved relative to the valve base between a normally closed position with valve apart engaging the valve base, and a open position with at least one segment of the spaced valve portion of the valve base to connect the valve port in fluid communication with the flow port and thereby allow fluid to flow from the flow port through the port port. valve; and (3) keeping the fluid in the storage chamber in an aseptic condition for life and releasing the fluid through the one-way valve assembly. A method according to claim 21, further characterized by the fact that it comprises the step of providing a hermetically sealed variable volume storage chamber and storing therein multiple portions of the fluid in a substantially airless condition, emanating the fluid in the substantially airless variable volume storage chamber over the life and release fluid through the one-way valve assembly. A method according to claim 21, further characterized by the fact that it comprises the means of aseptically filling the storage chamber with at least one of a milk product, a baby formula, and a product. Water based. A method according to claim 23, further characterized by the fact that it comprises keeping the milk-based product, the congratulations formula, and the substantially free water-based product substantially conserved throughout the filling and binding. product confirmation. A method according to claim 23, further characterized by the fact that it comprises the step of maintaining the milk-based product, the parabeb formula, and the water-based product at substantially room temperature over the entire shelf life. and releasing multiple doses of the product from the storage chamber.