Container and valve assembly for storing and dispensing substances, and related method

A device for storing fluid and dispensing multiple portions of the stored fluid therefrom, comprising:

• a flexible container defining a hermetically sealed, variable-volume storage chamber containing therein multiple portions of the fluid hermetically sealed within the storage chamber with respect to ambient atmosphere;
• and
• a one-way valve comprising a valve member formed of an elastic material and forming a normally closed valve opening and an inlet to the valve opening in fluid communication with the variable-volume storage chamber, wherein the valve member is movable between a normally closed position, and an open position with at least a segment of the valve member spaced away from the closed position to allow the passage of fluid from the variable-volume storage chamber through the valve opening, and configured such that one or more of (a) the energy required to open respective segments of the valve member progressively decreases in a direction from an upstream end toward a downstream end of the valve opening or (b) a segment of the valve member is not spaced away from the closed position substantially throughout any period of dispensing to maintain a hermetic seal between the valve opening and ambient atmosphere;
• wherein during dispensing of fluid through the one-way valve, the one-way valve and storage chamber substantially prevent ingress of air and maintain any remaining fluid in the storage chamber sealed with respect to ambient atmosphere.

A valve assembly that is connectable to a tube for dispensing a substance therefrom, the tube including a squeezable tubular body defining therein a tubular chamber for receiving and dispensing the substance therefrom, and a portion located at one end of the tubular body and connectable to the valve assembly, wherein the tubular body defines a first axially extending passageway forming an unobstructed axially extending flow path therethrough, the valve assembly comprising:

• (a) a valve body connectable to the tube and including:
• a body base defining a second axially extending passageway connectable in fluid communication with the first axially extending passageway and defining an unobstructed axially extending flow path therebetween;
• an axially extending valve seat defining a diameter less than a diameter of the body base;
• a first substantially tapered portion extending between the body base and the valve seat;
• and
• at least one flow aperture axially extending in a direction of an axis of the valve assembly through the substantially tapered portion adjacent to the valve seat;
• and
• (b) a valve cover formed of an elastic material defining a predetermined modulus of elasticity, and including:
• a cover base mounted on the body base and fixedly secured against axial movement relative thereto, wherein the cover base defines a diameter less than a diameter of the body base to thereby form an interference fit therebetween;
• a valve portion overlying the valve seat, wherein the valve portion defines a predetermined radial thickness and a diameter less than a diameter of the valve seat to thereby form an interference fit therebetween, the valve portion and valve seat defining a normally closed, axially extending valve opening therebetween, and the valve portion is movable between a normally closed position with the valve portion engaging the valve seat and an open position with a segment of the valve portion spaced away from the valve seat to allow the passage of substance at a predetermined valve opening pressure therebetween;
• and
• a second substantially tapered portion extending between the cover base and valve portion, overlying the first substantially tapered portion of the body, and forming an interference fit therebetween;
• and
• wherein (a) one or more of i) the valve seat diameter, ii) a degree of interference between the valve cover and valve seat, iii) the predetermined radial thickness of the valve portion, or iv) a predetermined modulus of elasticity of the valve cover material, is selected to (1) define a predetermined valve opening pressure generated upon squeezing the tube that allows passage of the substance from the storage chamber through the valve opening, and (2) hermetically seal the valve and prevent the ingress of bacteria through the valve and into the tube in the normally closed position, and (b) the valve cover and valve body define a progressively decreasing degree of interference along the valve opening in a direction from the interior to the exterior of the valve assembly.

A method comprising:

• aseptically storing substance in and dispensing substance from an internally sterile assembly including a variable-volume storage chamber, and a one-way valve coupled in fluid communication with the variable-volume storage chamber and including an elastic valve member forming a normally closed valve opening, wherein the valve member is movable between a normally closed position, and an open position with at least a segment of the valve member spaced away from the closed position to allow the passage of substance from the variable-volume storage chamber through the valve opening, and configured such that one or more of (a) the energy required to open respective segments of the valve member progressively decreases in a direction from an upstream end toward a downstream end of the valve opening or (b) a segment of the valve member is not spaced away from the closed position substantially throughout any period of dispensing to maintain a hermetic seal between the valve opening and ambient atmosphere;
• the steps of storing and dispensing including
• (i) sterile filling the variable-volume storage chamber with a substance;
• (ii) hermetically sealing the substance within the variable-volume storage chamber;
• (iii) dispensing a plurality of different portions of the substance at different points in time from the variable-volume storage chamber through the one-way valve;
• and
• (iv) maintaining the substance within the variable-volume storage chamber sterile and hermetically sealed with respect to ambient atmosphere throughout steps (ii) and (iii).

A device for aseptically storing and dispensing a substance, comprising:

• an assembly including a variable-volume storage chamber, and a one-way valve coupled in fluid communication with the variable-volume storage chamber and including an elastic valve member forming a normally closed valve opening,
• wherein the valve member is movable between a normally closed position, and an open position with at least a segment of the elastic valve member spaced away from the closed position to allow the passage of substance from the variable-volume storage chamber through the valve opening, and configured such that one or more of (a) the energy required to open respective segments of the valve member progressively decreases in a direction from an upstream end toward a downstream end of the valve opening or (b) a segment of the valve member is not spaced away from the closed position substantially throughout any period of dispensing to maintain a hermetic seal between the valve opening and ambient atmosphere, and
• wherein the variable-volume storage chamber is sterile filled with a substance, the substance is hermetically sealed in the variable-volume storage chamber, and the assembly maintains the substance within the variable-volume storage chamber sterile and hermetically sealed with respect to ambient atmosphere throughout dispensing a plurality of different portions of the substance from the storage chamber through the one-way valve.

A container for aseptically storing fluid and dispensing multiple portions of the stored fluid therefrom, comprising:

• a flexible container defining a hermetically sealed, variable-volume storage chamber containing therein multiple portions of fluid in an aseptic condition and hermetically sealed within the storage chamber with respect to ambient atmosphere;
• a one-way valve comprising a valve member formed of an elastic material and forming a normally closed valve opening and an inlet to the valve opening in fluid communication with the variable-volume storage chamber, wherein the valve member is movable in response to fluid at the inlet to the valve opening exceeding a valve opening pressure between (i) a normally closed position and (ii) an open position with at least a segment of the valve member spaced away from the closed position to allow fluid from the variable-volume storage chamber to be dispensed through the valve opening, and configured such one or more of (a) the energy required to open respective segments of the valve member progressively decreases in a direction from an upstream end toward a downstream end of the valve opening or (b) a segment of the valve member is not spaced away from the closed position substantially throughout any period of dispensing to maintain a hermetic seal between the valve opening and ambient atmosphere, and
• wherein during dispensing of fluid through the one-way valve, the one-way valve and storage chamber maintain any remaining fluid in the storage chamber in an aseptic condition and sealed with respect to ambient atmosphere.

A method for aseptically storing fluid and dispensing multiple portions of the stored fluid therefrom, comprising the following steps:

• providing a flexible container defining a hermetically sealed, variable-volume storage chamber containing therein multiple portions of fluid in an aseptic condition and hermetically sealed within the storage chamber with respect to ambient atmosphere;
• providing a rigid or semi-rigid outer body and receiving therein the flexible container;
• providing a one-way valve comprising a valve member formed of an elastic material and forming a normally closed valve opening and an inlet to the valve opening in fluid communication with the variable-volume storage chamber;
• pressurizing fluid at the inlet to the valve opening to a pressure at least equal to a valve opening pressure and moving the elastic valve member between (i) a normally closed position and (ii) an open position with at least a segment of the valve member spaced away from the closed position, and, in turn, dispensing fluid from the variable-volume storage chamber through the valve opening;
• and
• during dispensing of fluid through the one-way valve, maintaining any remaining fluid in the storage chamber in an aseptic condition and sealed with respect to ambient atmosphere;
• wherein the step of providing the one-way valve includes providing the one-way valve with a configuration such that one or more of (a) the energy required to open respective segments of the valve member progressively decreases in a direction from an upstream end toward a downstream end of the valve opening or (b) a segment of the valve member is not spaced away from the closed position substantially throughout any period of dispensing to maintain a hermetic seal between the valve opening and ambient atmosphere.

A method comprising:

• storing fluid in a device comprising (i) a flexible container defining a hermetically sealed, variable-volume storage chamber containing therein multiple portions of the fluid hermetically sealed within the storage chamber with respect to ambient atmosphere and (ii) a one-way valve comprising (a) a valve member formed of an elastic material and forming a normally closed valve opening, wherein the valve member is movable between a normally closed position, and an open position with at least a segment of the valve member spaced away from the closed position to allow the passage of fluid from the variable-volume storage chamber through the valve opening, and configured such that one or more of (I) the energy required to open respective segments of the valve member progressively decreases in a direction from an upstream end toward a downstream end of the valve opening or (II) a segment of the valve member is not spaced away from the closed position substantially throughout any period of dispensing to maintain a hermetic seal between the valve opening and ambient atmosphere, and (b) an inlet to the valve opening in fluid communication with the variable-volume storage chamber;
• and
• dispensing at least one of the multiple portions of the stored fluid, the dispensing step comprising:
• pressurizing fluid at the inlet to the valve opening to a pressure at least equal to a valve opening pressure and moving the elastic valve member between (i) a normally closed position and (ii) an open position with at least a segment of the valve member spaced away from the closed position, and, in turn, dispensing fluid through the valve opening;
• and
• during dispensing of fluid through the one-way valve, substantially preventing ingress of air and thereby maintaining any remaining fluid in the storage chamber sealed with respect to ambient atmosphere.

A method comprising the following steps:

• (a) aseptically storing fluid in a device comprising a flexible container defining a hermetically sealed, variable-volume storage chamber containing therein multiple portions of the fluid in an aseptic condition and hermetically sealed within the storage chamber with respect to ambient atmosphere;
• a rigid or semi-rigid outer body and receiving therein the flexible container;
• and a one-way valve comprising a valve member formed of an elastic material and forming a normally closed valve opening and an inlet to the valve opening in fluid communication with the variable-volume storage chamber;
• (b) pressurizing fluid at the inlet to the valve opening to a pressure at least equal to a valve opening pressure and moving the elastic valve member between (i) a normally closed position and (ii) an open position with at least a segment of the valve member spaced away from the closed position, and, in turn, dispensing fluid from the variable-volume storage chamber through the valve opening;
• and
• (c) during dispensing of fluid through the one-way valve, maintaining any remaining fluid in the storage chamber in an aseptic condition and sealed with respect to ambient atmosphere;
• wherein the one way valve is configured such that one or more of (a) the energy required to open respective segments of the valve member progressively decreases in a direction from an upstream end toward a downstream end of the valve opening or (b) a segment of the valve member is not spaced away from the closed position substantially throughout any period of dispensing;
• and further performing the step of maintaining a hermetic seal between the valve opening and ambient atmosphere during said dispensing step.

A device for storing fluid and dispensing stored fluid therefrom, comprising:

• a manually squeezable body containing a storage chamber therein;
• a fluid within the storage chamber;
• a one-way valve comprising a valve seat and a valve member formed of an elastic material overlying the valve seat and forming a normally closed valve opening therewith defined by a seam between the valve seat and the valve member and defining a valve opening pressure, and an inlet to the valve opening in fluid communication with the storage chamber,
• wherein the valve member is movable between a normally closed position in which the valve member engages the valve seat, and an open position with at least a segment of the valve member spaced away from the closed position to allow passage of at least a portion of fluid from the storage chamber through the valve opening, and configured such that substantially throughout any period of dispensing the one-way valve substantially prevents the ingress of bacteria or other unwanted impurities from the ambient atmosphere through the one-way valve and into the storage chamber;
• wherein one or more of (a) the valve member and the valve seat define a progressively decreasing degree of interference along the valve opening in a direction from the interior to the exterior of the one way valve, (b) the energy required to open respective segments of the valve member progressively decreases in a direction from an upstream end toward a downstream end of the valve opening or (c) a segment of the valve member is not spaced away from the closed position substantially throughout any period of dispensing to maintain a hermetic seal between the valve opening and ambient atmosphere;
• and
• an airflow passageway in fluid communication between an exterior and an interior of the manually squeezable body for regulating a flow of air into the interior of the body, wherein bacteria and unwanted impurities in air passing through the airflow passageway are substantially prevented from contaminating the fluid in the storage chamber;
• wherein upon manually squeezing the manually squeezable body, fluid at the inlet to the valve opening is pressurized to a pressure at least equal to the valve opening pressure and moving the elastic valve member between the normally closed position and the open position with at least a segment of the valve member spaced away from the closed position, and, in turn, dispensing at least a portion of the stored fluid through the valve opening;
• and
• wherein upon relaxation of the squeezing, air enters the interior of the manually squeezable body through the airflow passageway without bacteria and unwanted impurities in said air contaminating the fluid in the storage chamber.