Patent Application
20160023885
The present invention relates to pouch connectors and related methods, and more particularly, to pouch connectors and related methods including piercing members for piercing the pouches and, in turn, placing the connectors in fluid communication with the pouches.
Aseptic packaging is widely used to prolong the shelf life of food and drink products. With conventional aseptic packaging, the product is filled and sealed in the package under aseptic conditions. It is well known from people of the art, that aseptic conditions are aimed at preventing as well as possible, contamination of the product and of the inner packaging in contact with the product, from being exposed to germs of the environment. The product is said to be aseptic, when the number of packages filled does not exceed 1 per 3,000 units. The almost irreducible rate of failure is mainly due to the fact that containers are filled open in the environment within the filling machine, which itself is cleaned aseptically.
One such prior art dispenser system that employs an aseptically filled package is shown in U.S. Pat. No. 6,024,242. The package includes a pouch that holds the food or beverage, and a flexible, open-ended tube connected to the pouch for dispensing the product therethrough. A pinch valve is used in the dispenser to pinch the open end of the tube and thereby close the tube from the ambient atmosphere. In order to dispense product, the pinch valve is released from the tube, and the product is in turn allowed to flow from the pouch and through the open end of the tube.
The prior art dispenser and packaging are limited by numerous drawbacks, including:
Thus, a method to alleviate the risks discussed above including the following risks is needed:
All risks related to the connection of a tubing to a pouch can be significantly reduced. The risk related to the contamination of the connector also needs to be addressed to dramatically reduce the rate of Nosocomial Infections, especially, and in general, to reduce the risk of contamination of all the products filled in pouches, whether for injection, feeding, industrial or any other kinds of uses of products delivered in pouches.
It is an object of the present invention to overcome one or more of the above-described drawbacks and/or disadvantages of the prior art.
In accordance with a first aspect, the present invention is directed to a connector for a pouch defining a storage chamber. The connector comprises a housing including a piercing member, unexposed to human interaction, hermetically sealed within the housing and movable between (i) a disengaged position wherein the piercing member is not piercing the pouch, and (ii) an engaged position wherein the piercing member is piercing the pouch, and is in fluid communication with the storage chamber of the pouch. A first external pouch-engaging surface of the housing is engageable with a first side of the pouch and forms a hermetic seal therebetween. A stop member of the pouch connector includes a second pouch-engaging surface engageable with a second side of the pouch opposite the first side of the pouch, and a stop surface that stops the piercing member in the engaged position.
In accordance with another aspect, the present invention provides for a method for sealing surfaces together in a sterile manner so that no germs are transported inside the pouch by the piercing member. In accordance with another aspect, the sealing process itself is between the outer device. If the sealing process is physical (e.g., ultrasonic or high frequency sealing), there is a risk of sealing both sides of the pouch at once. In some embodiments, only one side of the pouch is sealed while the other side of the pouch is not sealed around the outflow hole created by the piercing member. If the sealing process is chemical, the leach-ability of the chemical into the wall of the pouch may be propagated into the liquid contained in the pouch, and therefore the chemical and/or the pouch material is selected to prevent or substantially prevent this from occurring.
One rationale of the invention is based on the demonstration that physical curing of specific adhesives, such as some ultraviolet or “UV” curing liquid silicones and acrylics, can also under certain conditions of wavelength, energy and time of exposure, sterilize the contact surfaces at substantially the same time. As an example, an ultraviolet wavelength in the range of about 254 nanometers, known to damage the DNA or the RNA of germs, has been demonstrated to sterilize the surfaces sealed together by different adhesives, during the curing of the adhesives, under UV pulse light within the similar range of about 254 nanometers and about 365 nanometers. The cured liquid silicone, in a currently preferred configuration, has been demonstrated to be biocompatible and not subject to toxic levels of extractibles.
As a result, curing of the chemical adhesive, under specific controlled physical conditions, allows to both limit the seal to the pouch surface, and sterilize the interface surfaces sealed together, in a definitive way regardless of the environment that the filled pouch is going to be exposed to.
In some embodiments of the present invention, the stop member is coupled to the housing, and the stop member and/or housing is movable relative to the other. In some such embodiments, a hinge is connected between the stop member and housing. In some such embodiments, the stop member and housing are formed integral with each other, and the hinge is a living hinge extending between the stop member and housing.
In some embodiments of the present invention, the pouch connector further comprises a locking member coupled to the piercing member in the disengaged position and preventing movement of the piercing member from the disengaged position to the engaged position. In some such embodiments, the locking member includes a frangible portion frangibly connecting the locking member to the housing with the piercing member in the disengaged position, and the locking member is frangibly removable from the housing to permit movement of the piercing member from the disengaged position to the engaged position. Some embodiments of the present invention further comprise an actuator coupled to the piercing member for moving the piercing member from the disengaged position to the engaged position. In some such embodiments, the actuator defines a manually-engageable surface that is manually engageable to move the actuator and piercing member from the disengaged position to the engaged position.
In some embodiments of the present invention, the pouch connector further includes a spring coupled to the piercing member and normally biasing the piercing member in a direction toward the disengaged position. In some such embodiments, the spring is defined by a wall of the housing. In some such embodiments, at least a portion of the wall of the housing defines a bellows that forms the spring normally biasing the piercing member toward the disengaged position. In some such embodiments, the wall of the housing is made of a relatively flexible material, such as low durometer polypropylene, and has a shape providing longitudinal flexibility and resilience, such as a bellows and/or a dome spring, with the ability to store some resilience energy in radial deformation during the longitudinal motion of the housing bearing the piercing member molded preferably in a single piece with the housing and the sealing surface.
In some embodiments of the present invention, the first pouch-engaging surface includes a first sealant thereon for sealing the first pouch-engaging surface to the first side of the pouch, and the second pouch-engaging surface includes a second sealant thereon for sealing the second pouch-engaging surface to the second side of the pouch. In some such embodiments, each of the first and second sealants is an adhesive, a plastic film and/or a thermally weldable surface, by sealing (via ultrasonic, high frequency, infrared or otherwise) as well as other methods known in the art.
In a preferred embodiment, a sealant adhesive, curable under high energy UV pulse light, for example, allows to seal only the interfaces between the seal surface of the device and the outer layer(s) of the pouch. The sterilization of the interface may be accomplished via a UV source during curing itself.
In accordance with another aspect, the present invention is directed to a combination of a pouch connector and a pouch, wherein the pouch includes a first side sealed to the first pouch-engaging surface, and a second side sealed to the second pouch-engaging surface. In some embodiments, the chamber of the pouch is empty and sterile, and the interior of each of the housing and stop member is sterile. In other embodiments, the chamber of the pouch is filled with a substance, such as any of numerous different types of fluids, the chamber is sterile, and the interior of each of the housing and stop member is sterile.
In some embodiments of the present invention, the pouch connector further includes a port coupled in fluid communication with the piercing member and/or interior of the housing for receiving substance from the chamber of a pouch when the piercing member is in the engaged position. Some embodiments of the present invention include a conduit coupled in fluid communication with the piercing member and/or interior of the housing, and a valve coupled in fluid communication with the conduit for controlling a flow of substance from the connector and conduit therethrough.
In accordance with another aspect, the present invention is directed to a method comprising the following steps:
Some embodiments of the present invention further comprise the steps of allowing substance to flow from a storage chamber of the pouch, through the pierced portion of the pouch, and into the pouch connector.
Some embodiments of the present invention further comprise the steps of sterilizing at least a portion of each of the first and second sides of the pouch and the first and second pouch-engaging surfaces prior to the sealing steps, and maintaining the interfaces of the first and second pouch-engaging surfaces and first and second sides of the pouch, respectively, sterile after the sealing steps. Some such embodiments further comprise performing the sealing steps under an overpressure of sterile gas, such as sterile (such as by filtering) air. In an alternative embodiment, the pouch, pouch connector or both are sterilized in a chamber to maintain an aseptic condition. In each case, the method may further comprise the step of sterilizing the sealed pouch prior to filling same. Preferably, the sterilizing step includes at least one of (i) transmitting radiation, such as gamma or e-beam radiation, and (ii) transmitting a fluid sterilant, such as VHP or nitric oxide, onto the pouch and/or pouch connector. In other embodiments of the present invention, the interface(s) between the pouch connector and pouch are sterilized during activation of an adhesive or other sealant located at the interface(s), such as by UV or other pulsed radiation activation, or by chemical interaction between the adhesive or other sealant and the interface surfaces of the pouch and pouch connector.
Some embodiments of the present invention further comprise the following steps: prior to the moving step (i.e., step (iii)), maintaining a locking member coupled to the piercing member and preventing movement of the piercing member from the disengaged position to the engaged position, and then removing the locking member and, in turn, moving the piercing member from the disengaged position to the engaged position.
In some embodiments of the present invention, the flexible pouch defines a sealed, aseptic storage chamber adapted to receive therein a substance to be stored and dispensed 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 beverage. In one such embodiment, the pouch is formed of a plastic laminate including an oxygen/water barrier and an approved food contact layer. In one such embodiment, the substance is selected from the group including lyophilized substances or liquids such as a milk-based product, milk, evaporated milk, condensed milk, cream, half-and-half, baby formula, growing up milk, yogurt, soup, ice cream, powder, juice, syrup, coffee, condiments, ketchup, mustard, mayonnaise, and coffee aroma. In at least some embodiments, the pouch is filled with a substance that is a drug, medicament or other therapy to be delivered to a patient. In another aspect, the pouch and pouch connector, in combination with a sterile connector at the other end of the tube, is used for transporting all kinds of substances including products which cannot be a source of contamination of the environment into which they are aimed at being delivered, or vice versa.
In accordance with another aspect, a significant issue for the international space station, is to prevent germs from being conveyed to the station and the astronauts, or the opposite, i.e., to prevent people on the ground from being exposed to possibly hazardous material(s) to be shipped from the station. The pouch and pouch connector may be used to store and deliver water, which is in scarce quantity and vital for astronauts who are expected to stay during long periods of time in confined station or space transportation modules.
In another aspect, the pouch and pouch connector are useful for transporting specific germ samples which cannot be contaminated by other germs or germ colonies. In these situations, the pouch connector might be sealed to an empty pouch and the pouch connector connected to a tubing or to a stopper which can be over-molded, co-molded or otherwise connected to the pouch connector. The pouch connector is used to fill the pouch with fluids, liquids, gases, or solids, preferably particles, lyophilized or powder products, which are filled according to another specific technology.
In some such embodiments, the pouch connector is used to fill a pouch, either via a stopper, or a sterile connector molded in one piece with the pouch connector. Such a sterile connector is disclosed in co-pending U.S. patent application Ser. No. 13/080,537, filed Apr. 5, 2011, entitled “Aseptic Connector with Deflectable Ring of Concern and Method”, which claims priority from U.S. provisional patent application Ser. No. 61/320,857, filed Apr. 5, 2010, entitled “Aseptic Connector with Deflectable Ring of Concern and Method”, which are both hereby expressly incorporated by reference in their entireties as part of the present disclosure.
Some embodiments of the present invention further comprise a flexible tube coupled in fluid communication between the pouch and pouch connector. In one such embodiment, a flexible line or tube is connected to the flexible pouch and pouch connector by at least one of (i) a fitting mounted on at least one of the flexible pouch and pouch connector that frictionally engages a respective end of the tube to form a hermetic seal therebetween, (ii) a heat seal, (iii) a weld, and (iv) an adhesive.
In accordance with another aspect, the present invention is directed to an assembly in combination with a dispenser. The dispenser comprises a relatively rigid container receiving therein the flexible pouch, and a surface for supporting and positioning the pouch connector for dispensing substances therefrom and into another container. In one such embodiment, the dispenser further includes a pump operatively coupled to the pouch and/or pouch connector, and a control unit electrically coupled to the pump to control operation of the pump and, in turn, control dispensing of substance within the pouch, through the pouch connector, and into another container. In one such embodiment, the dispenser includes at least one pouch, and the at least one pouch includes at least one of coffee, coffee concentrate, milk, milk-based product, half-and-half, and creamer. In one such embodiment, the dispenser further includes at least one pouch containing coffee aroma.
In accordance with another aspect, the present invention is directed to a flexible pouch and valve assembly for aseptically storing a substance, dispensing multiple portions of the stored substance therefrom, and maintaining substance remaining in the pouch in an aseptic condition sealed with respect to ambient atmosphere. The flexible pouch and valve assembly are receivable within a relatively rigid housing and adapted to cooperate with a pump for pumping discrete portions of substance from the pouch and through the pouch connector to dispense the substance therefrom.
In one embodiment of the present invention, the pouch contains a milk-based product, and a pouch connector or means for substantially preventing micro-organisms from entering into the variable-volume storage chamber and for permitting the milk-based product to be stored and dispensed without refrigeration.
In some embodiments of the present invention, the method comprises the step of aseptically filling the pouch with at least one of a milk-based product, a baby formula, and a water-based product. One such embodiment further comprises the step of maintaining the milk-based product, baby formula, or water-based product substantially preservative-free substantially throughout the filling and dispensing of the product. One such embodiment further comprises the step of maintaining the milk-based product, baby formula, or water-based product substantially at ambient temperature throughout the shelf-life and dispensing of multiple servings of the product from the pouch.
Some embodiments of the present invention further comprise the steps of: (i) providing a flexible tube coupled on one end in fluid communication with the pouch and/or pouch connector, and a pump in the form of a peristaltic pump; and (ii) engaging with the peristaltic pump an external portion of the flexible tube and pumping discrete portions of fluid therethrough.
One advantage of the present invention is that it enables a pouch connector to be connected to the pouch either before or after filling the pouch. Another advantage of the present invention is that the connector maintains the chamber of the pouch hermetically sealed throughout the shelf-life, storage and/or non-use of the pouch, but allows the connector to be readily placed in fluid communication with the chamber of the pouch by moving the piercing member from the disengaged position to the engaged position. Yet another advantage of currently preferred embodiments of the present invention is that they can specifically eliminate any risk for the piercing member, also referred to as a “spike”, from being contaminated by the hands of the operator. Yet another advantage of the present invention is that the pouch connector can be connected to a dispensing line or other conduit which, in turn, can be connected to a sterile connector or other one-way valve to control dispensing of the fluid or other substance therethrough.
One advantage of some currently preferred embodiments of the present invention is that the pouch connector can hermetically seal the product in the pouch throughout, for example, the shelf life of the product. The pouch connector is able to maintain the interior of the pouch in a sterile condition.
Another advantage of the pouch connector, especially if it is applied to the pouch after filling, is that the same filling machine traditionally used for filling pouches, can be used, even simplified, by mere disconnection of the sealing fixture that some of the machines have, to seal the port of the connector inside of the pouch prior to filling. As a consequence, the safety level of the existing filling machine can be increased and no significant additional capital expenses are needed to use the pouch connector.
Another advantage of the pouch connector is to lower the rate of contamination of existing filling machines and the failure rate of the pouch aseptic filling process. Moreover, when the pouch connector is sealed to a tube in combination with a non-contamination sterile connector, the rate of nosocomial infection should also be dramatically lowered when the pouch connector and deflectable ring of concern valve are used in combination as in a currently preferred configuration.
Other advantages of the present invention and/or of the currently preferred embodiments thereof will become readily apparent in view of the following detailed description and accompanying drawings.
In
The pouch 100 can be configured and formed using a variety of materials depending on the desired application or field of use. In one embodiment, the material of the pouch 100 is an oxygen/water barrier material. An exemplary such material is a plastic laminate with an approved food contact material layer. In one such embodiment, the material is a heat-sealable 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 biaxially orientated, polyethylene, polypropylene, and polystyrene. Examples of oxygen/water barrier materials are ethylene vinyl alcohol (EVOH) and silicon oxide. An exemplary heat-sealable material is polyethylene, such as linear low-density, ultra linear low-density, high-density or metallocene catalyzed polyethylene. An exemplary pouch material is a laminate including a nylon co-polymer, on the outside, EVOH, and metallocene catalyzed polyethylene on the inside, wherein the layers of the laminate are adhered together in a manner known to those of ordinary skill in the pertinent art.
The pouch 100 may be initially filled with a substance 110 as described above using any number of techniques known in the art. In some embodiments, the pouch 100 is filled using filling techniques such as those found in U.S. patent application Ser. No. 12/901,420, filed Oct. 8, 2010 and entitled “Device With Co-Molded Closure, One-Way Valve and Variable-Volume Storage Chamber and Related Method.” The pouch 100 may also be filled using methods such as the INTASEPT™ technology whereby hermetically sealed membranes provide ‘tamper evident’ protection, before and after filling. These double membranes also maintain the high barrier properties of the pouch. Before filling, the top membrane is completely sealed and the internal membrane is partially sealed. During filling, the internal membrane is completely heat-sealed from below. After filling, the internal membrane is fully sealed, providing tamper-evidence for the filled pack.
With reference to
The main connector 400 of pouch connector 200 is adapted to fixedly secure or otherwise attach to a portion of the pouch 100. In some embodiments, the main connector 400 is coupled to one side of pouch 100 after the pouch has been filled with a substance 110. In some other embodiments, the main connector 400 is coupled to one side of pouch 100 before the pouch has been filled with a substance 100. The main connector 400 includes a base portion 410, a body portion 430, a piercing member 450 and an actuating portion 420. The base portion 410 is a flexible pouch-engaging surface which couples to a side of pouch 100. Connected to the base portion 410 is body portion 430. Preferably, body portion 430 is a housing formed of a spring-like thermoplastic material that is normally biased towards an uncompressed disengaged position, and compressible upon actuation of main connector 400 into an engaged position. The main connector 400 further includes a piercing member 450 having an angled piercing surface 460 and a piercing tip 470, for piercably engaging pouch 100 when main connector 400 is actuated. The piercing member 450 may be formed of a plastic or thermoplastic material. In some embodiments, the piercing member 450 is formed of a metal. In at least some other embodiments, the piercing member 450 includes both plastic and metal portions. It will be understood that the piercing member 450 may alternatively include any needle, pin, spike, dowel, nail, screw or any other sharp or pointed member configured to pierce, slash, cut, slit or otherwise provide a hole or passageway through a portion of pouch 100. The piercing member 450 of the main connector 400 is further coupled to the actuating portion 420 configured to drive the piercing member 450 when engaged by the user. Actuator portion 420 defines a manually-engageable surface that is manually engageable to move the actuator portion, and thus compress body portion 430, with piercing member 450 within, from a disengaged position, wherein the piercing member 450 has not pierced pouch 100, to an engaged position, wherein the piercing member 450 pierces pouch 100.
As seen in
In at least some embodiments, the safety cap 300 and the main connector 400 are sterilized upon coupling of the polymeric membranes 250. The pouch connector 200 is preferably sterilized prior to assembly by, for example, applying radiation, such as gamma, ultraviolet or e-beam radiation thereto, or another type of sterilant, such as vaporized hydrogen peroxide (“VHP”). It will be understood that sterilization may be performed during formation of the pouch connector 200, during assembly of the pouch connector 200 to the pouch 100 and/or after assembly of the pouch connector 200 to pouch 100. In embodiments where sterilization is performed on the pouch 100, the sterilization method should be chosen so that a substance 110 which may be contained in the pouch 100 would not be adversely affected.
The apparatus and methods for sterilizing the pouch connector may take the form of any of the apparatus and methods disclosed in the following commonly assigned patents and patent applications which are hereby expressly incorporated by reference as part of the present disclosure: U.S. patent application Ser. No. 10/766,172, filed Jan. 28, 2004, entitled “Medicament Vial Having A Heat-Sealable Cap, And Apparatus and Method For Filling The Vial”, which is a continuation-in-part of similarly titled U.S. patent application Ser. No. 10/694,364, filed Oct. 27, 2003, which is a continuation of similarly titled co-pending U.S. patent application Ser. No. 10/393,966, filed Mar. 21, 2003, which is a divisional of similarly titled U.S. patent application Ser. No. 09/781,846, filed Feb. 12, 2001, now U.S. Pat. No. 6,604,561, issued Aug. 12, 2003, which, in turn, claims the benefit of similarly titled U.S. Provisional Application Ser. No. 60/182,139, filed Feb. 11, 2000; and U.S. Provisional Patent Application No. 60/443,526, filed Jan. 28, 2003; and similarly titled U.S. Provisional Patent Application No. 60/484,204, filed Jun. 30, 2003; U.S. patent application Ser. No. 10/655,455, entitled “Sealed Containers And Methods Of Making And Filling Same”, filed Sep. 3, 2003, which, in turn, claims the benefit of similarly-titled U.S. Provisional Patent Application No. 60/408,068 filed Sep. 3, 2002; U.S. Provisional Patent Application No. 60/551,565, filed Mar. 8, 2004, titled “Apparatus and Method for Molding and Assembling Containers with Stoppers”; U.S. patent application Ser. No. 10/600,525 filed Jun. 19, 2003 titled “Sterile Filling Machine Having Needle Filling Station Within E-Beam Chamber”, which, in turn, claims the benefit of similarly-titled U.S. Provisional Application No. 60/390,212 filed Jun. 19, 2002; U.S. patent application Ser. No. 10/983,178 filed Nov. 5, 2004 titled “Needle Filling and Laser Sealing Station”, which, in turn, claims the benefit of similarly-titled U.S. Provisional Patent Application No. 60/518,267 filed Nov. 7, 2003 and similarly-titled U.S. Provisional Patent Application No. 60/518,685 filed Nov. 10, 2003; U.S. Provisional Patent Application No. 60/550,805 filed Mar. 5, 2004 titled “Apparatus for Needle Filling and Laser Resealing”; and U.S. patent application Ser. No. 08/424,932 filed Apr. 11, 1995 now U.S. Pat. No. 5,641,004 issued Jun. 24, 1997 titled “Process for Filling a Sealed Receptacle Under Aseptic Conditions.”
As shown in
In at least some embodiments, the main connector 400 is further connected to a pump (not shown) for dispensing the substance through the main connector 400. The pump may be a conventional peristaltic pump that is rotatably driven to pump substance 110 from the reservoir pouch 100, through the pouch connector 200, and into a receiving container or other receptacle. Alternatively, the pouch 100 may be used in combination with any of numerous different pumps, such as electrically-actuated, manually-actuated, or pedal actuated pumps, or may be used with dispensers that employ pressurized air or other gas to pump the fluid through the valve, that are currently known, or that later become known.
With the safety ring 800 removed, a user 1000 (e.g., a physician, nurse, health care provider, server, consumer, etc.) may then grasp the safety cap 300 and the main connector 400 to actuate the pouch connector 200.
It will be understood that the configuration of the piercing member 450 and the pouch connector 200 as a whole may be varied in a number of ways. For example, instead of axial actuation, the main connector 400 may be configured as a threaded combination. A body portion 430 of the main connector 400 may include a female thread while the actuating member 420 includes a complementary male thread. To actuate, the actuating member 420 may be rotated relative to the body portion 430 of the main connector 400 so that the threads are advanced. By rotating the actuating member 420, the piercing member 450 may be advanced to pierce the pouch 100 and provide fluid communication between the pouch 100 and a dispensing line 500 or valve 600.
One advantage of the present invention is that the same product may remain shelf-stable in the pouch, whether refrigerated or not, throughout the shelf life and usage of the pouch. Accordingly, the present invention is particularly suitable for storing and dispensing ready-to-drink products, including non-acid products, such as those that are generally difficult to preserve upon opening of the package, including without limitation, drinks such as wine, milk-containing drinks, cocoa-based drinks, malt based drinks, tea, coffee, coffee concentrate, tea concentrate, other concentrates for making beverage or food products, sauces, such as cheese and milk, or meat-based sauces, gravies, soups, and nutritional drink supplements, meal replacements, baby formulas, milks, growing-up milks, etc. Accordingly, a significant advantage of the currently preferred embodiments of the present invention is that they allow the above-mentioned and any of numerous other products to be distributed and stored at an ambient temperature and allow the product to remain shelf-stable even after dispensing product from the pouch, 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 customary temperature, or for any of numerous reasons that are currently known or that later become known.
The pouch 100 and pouch connector 200 may be modified in combination with subject matter disclosed in U.S. patent application Ser. No. 11/295,274, filed Dec. 5, 2005, entitled “One-Way Valve And Apparatus Using The Valve”, U.S. patent application Ser. No. 11/295,251, filed Dec. 5, 2005, entitled “Method Of Using One-Way Valve And Related Apparatus”, U.S. Provisional Patent Application Ser. No. 60/633,332, filed Dec. 4, 2004, U.S. Provisional Patent Application Ser. No. 60/644,130, filed Jan. 14, 2005, both of which are entitled “One-Way Valve, Apparatus and Method of Using the Valve”, U.S. Provisional Patent Application Ser. No. 60/757,161, filed Jan. 5, 2006, and U.S. Provisional Patent Application Ser. No. 60/843,131, filed Sep. 9, 2006, both of which are entitled “One-Way Valve and Apparatus and Method of Using the Valve”. Each of the foregoing patent applications is hereby incorporated by reference in its entirety as part of the present disclosure.
The pouch 100 and pouch connector 200 may further be modified to include one or more penetrable and resealable members, penetrable by a needle or injection member for aseptically filling pouch 100, wherein the resulting penetration aperture is resealable by radiation or laser energy, or by a liquid sealant, such as liquid silicone, in accordance with the teachings of the following patents and co-pending patent applications that are hereby expressly incorporated by reference as part of the present disclosure: U.S. Pat. No. 6,604,561, entitled “Medicament Vial Having a Heat-Sealable Cap, and Apparatus and Method for Filling the Vial”; U.S. Pat. No. 6,684,916, entitled “Medicament Vial Having a Heat-Sealable Cap, and Apparatus and Method for Filling the Vial”; U.S. patent application Ser. No. 10/694,364, filed Oct. 27, 2003, entitled “Medicament Vial Having a Heat-Sealable Cap, and Apparatus and Method for Filling the Vial”; U.S. patent application Ser. No. 10/766,172, filed Jan. 28, 2004, entitled “Medicament Vial Having a Heat-Sealable Cap, and Apparatus and Method for Filling the Vial”; U.S. patent application Ser. No. 10/600,525, filed Jun. 19, 2003, entitled “Sterile Filling Machine Having Needle Filling within E-Beam Chamber”; U.S. patent application Ser. No. 10/655,455, filed Sep. 3, 2003, entitled “Sealed Containers and Methods of Making and Filling Same”; U.S. provisional patent application Ser. No. 60/518,685, filed Nov. 10, 2003, entitled “Needle Filling and Laser Sealing Station”; U.S. patent application Ser. No. 11/070,440, filed Mar. 2, 2005, entitled “Apparatus for Needle Filling and Laser Resealing”; U.S. provisional patent application Ser. No. 61/250,363, filed Oct. 9, 2009, entitled “Device with Co-Molded Closure, One-Way Valve and Variable-Volume Storage Chamber, and Related Method”; and U.S. patent application Ser. No. 12/901,420, filed Oct. 8, 2010, entitled “Device with Co-Molded Closure, One-Way Valve and Variable-Volume Storage Chamber, and Related Method”.
As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments 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 any of numerous different materials that are currently known, or that later become known for performing the function(s) of each such component. Similarly, the components of the apparatus may take any of numerous different shapes and/or configurations, additional components may be added, components may be combined, and one or more components or features may be removed.
This patent application is a continuation of U.S. patent application Ser. No. 13/279,141, filed on Oct. 21, 2011, entitled “Pouch Connector and Related Method”, now U.S. Pat. No. 9,090,445, claiming benefit pursuant to 35 U.S.C. §119(e) of U.S. Provisional Application Ser. No. 61/406,080, filed Oct. 22, 2010, entitled “Pouch Connector and Related Method”, U.S. Provisional Patent Application Ser. No. 61/406,937, filed Oct. 26, 2010, entitled “Pouch Connector and Related Method”, and U.S. Provisional Patent Application Ser. No. 61/407,349, filed Oct. 27, 2010, entitled “Pouch Connector and Related Method”, the contents of which are all hereby expressly incorporated by reference in their entirety as part of the present disclosure.
| Number | Date | Country | |
|---|---|---|---|
| 61406080 | Oct 2010 | US | |
| 61406937 | Oct 2010 | US | |
| 61407349 | Oct 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13279141 | Oct 2011 | US |
| Child | 14811330 | US |
