One-way valve and apparatus and method of using the valve
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
B65B-039/00
B65D-037/00
B67D-001/00
B67D-001/08
B67D-001/10
B67D-001/12
B67D-003/00
B67D-003/04
B65D-051/00
F04B-053/10
B05B-011/00
B65D-051/16
출원번호
US-0943536
(2015-11-17)
등록번호
US-9938128
(2018-04-10)
발명자
/ 주소
Py, Daniel
Chan, Julian V.
Adamo, Benoit
Houle, Nathaniel
출원인 / 주소
MEDINSTILL DEVELOPMENT LLC
대리인 / 주소
McCarter & English, LLP
인용정보
피인용 횟수 :
0인용 특허 :
138
초록▼
A flexible pouch and valve assembly is provided 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 assemb
A flexible pouch and valve assembly is provided 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 are adapted to cooperate with a pump for pumping discrete portions of substance from the pouch and through the one-way valve to dispense the substance therefrom. The assembly comprises a flexible pouch defining therein a variable-volume storage chamber sealed with respect to the ambient atmosphere for aseptically storing therein multiple portions of the substance. A one-way valve of the assembly includes a valve body defining an axially-extending valve seat and at least one flow aperture extending through the valve body and/or the valve seat.
대표청구항▼
1. An apparatus for aseptically storing a substance, dispensing multiple portions of the stored substance therefrom, and maintaining the substance remaining therein in an aseptic condition, the apparatus comprising: a storage chamber for aseptically storing therein multiple portions of the substance
1. An apparatus for aseptically storing a substance, dispensing multiple portions of the stored substance therefrom, and maintaining the substance remaining therein in an aseptic condition, the apparatus comprising: a storage chamber for aseptically storing therein multiple portions of the substance; anda one-way valve including a valve body defining at least one substantially axially-extending flow aperture therein connected or connectible in fluid communication with the substance from the storage chamber, a valve seat, and a valve portion overlying the valve seat formed of an elastic or flexible material, the valve seat and valve portion defining a normally-closed substantially axially-extending valve opening therebetween, and an inlet to the valve opening connected or connectible in fluid communication with the at least one flow aperture, wherein the valve portion is movable between (i) a normally closed position with the valve portion engaging the valve seat, and (ii) an open position with at least a segment of the valve portion spaced away from the valve seat to allow passage of the substance from the storage chamber through the valve opening, wherein in the normally closed and open positions the one-way valve prevents one or more of air or other gas, or micro-organisms or other contaminants from ambient atmosphere from flowing into the storage chamber through the valve;and a filter coupled in fluid communication between the storage chamber and ambient atmosphere configured to allow the one or more of air or other gas to flow therethrough into the storage chamber after dispensing of the substance therefrom, and to sterilize the one or more of air or other gas flowing into the storage chamber through the filter. 2. An apparatus as defined in claim 1, wherein pressurizing of the substance at the inlet to the valve opening to a pressure at least equal to the valve opening pressure causes the valve portion to move between the normally closed position and the open position, such that, in turn, a portion of the substance stored in the storage chamber can be dispensed through the one-way valve, and wherein, after dispensing of the substance through the one-way valve, the one or more of air or other gas flows into the storage chamber through the filter, and the filter sterilizes the one or more of air or other gas flowing into the chamber and thereby maintains any substance within the storage chamber in aseptic condition. 3. An apparatus as defined in claim 1, wherein the storage chamber contains therein the substance that is substantially preservative-free. 4. An apparatus as defined in claim 3, wherein the substance is one or more of an aseptic vaccine, medicine, pharmaceutical product, food, or beverage. 5. An apparatus as defined in claim 1, wherein the valve portion defines a dimension that is less than a dimension of the valve seat to form an interference fit with the valve seat in at least one location where the valve portion overlies the valve seat. 6. An apparatus as defined in claim 5, wherein one or more of (i) the valve portion and valve seat define a decreasing degree of interference therebetween in a direction from an upstream end toward a downstream end of the valve opening, (ii) the valve portion defines a decreasing radial thickness when moving in a direction from an upstream end toward a downstream end of the valve opening, or (iii) the valve portion and valve seat define a configuration such that energy required to open respective segments in the valve portion progressively decreases in a direction from an upstream end toward a downstream end of the valve opening. 7. An apparatus as defined in claim 1, wherein the valve seat is axially extending, and the valve portion is axially extending and covers a substantially axially-extending portion of the valve seat. 8. An apparatus as defined in claim 1, wherein the one-way valve forms an external portion of the apparatus. 9. An apparatus as defined in claim 1, wherein the storage chamber is a variable-volume storage chamber. 10. An apparatus as defined in claim 1, wherein the storage chamber is defined by a container that is semi-rigid or flexible. 11. An apparatus as defined in claim 1, wherein the storage chamber is defined by a flexible pouch or bladder. 12. An apparatus as defined in claim 1, wherein the apparatus includes an engageable portion configured to be squeezed and thereby pump the substance into the inlet of the one-way valve and through the one-way valve. 13. An apparatus as defined in claim 12, wherein the engageable portion is comprised of an elastic material that is normally biased toward a ready position and which, when squeezed, is configured to create an elastic spring force sufficient to restore the engageable portion to the ready position upon releasing of the engageable portion. 14. An apparatus as defined in claim 12, wherein the engageable portion is manually engageable. 15. An apparatus as defined in claim 14, wherein the manually engageable portion includes an actuator that is manually engageable to depress the actuator and, in turn, pump the substance into the inlet of the one-way valve and through the valve. 16. An apparatus as defined in claim 1, wherein the filter is a microbial filter. 17. An apparatus as defined in claim 1, wherein the filter defines a pore size of less than about 10 microns. 18. A method for aseptically storing substance and dispensing multiple portions of stored substance, comprising the following steps: (1) storing multiple portions of the substance in an aseptic condition in an apparatus comprising (i) a storage chamber; (ii) a one-way valve including a valve body defining at least one substantially axially-extending flow aperture therein connected or connectible in fluid communication with the substance from the storage chamber, a valve seat, and a valve portion formed of an elastic or flexible material overlying the valve seat, the valve portion and the valve seat defining a normally closed substantially axially-extending valve opening therebetween, and an inlet to the valve opening connected or connectible in fluid communication with the at least one flow aperture, wherein the valve portion is movable relative to the valve seat between a normally closed position with the valve portion engaging the valve seat, and an open position with at least a segment of the valve portion spaced away from the valve seat to allow passage of the substance from the storage chamber through the valve opening, wherein in the normally closed and open positions the one-way valve prevents one or more of air other gas, or micro-organisms or other contaminants from ambient atmosphere from flowing into the storage chamber through the valve, and (iii) a filter coupled in fluid communication between the storage chamber and ambient atmosphere configured to allow the one or more of air or other gas to flow therethrough into the storage chamber after dispensing of the substance through the one-way valve, and to sterilize the one or more of air or other gas flowing into the storage chamber through the filter; and(2) maintaining the substance in the storage chamber in an aseptic condition during a shelf life and dispensing of the substance through the one-way valve. 19. A method as defined in claim 18, wherein the storing step further comprises storing the substance in the storage chamber one or more of (i) preservative-free, or (ii) at ambient temperature; andthe maintaining step further comprises maintaining the substance in the storage chamber one or more of (i) preservative-free, or (ii) at ambient temperature during the shelf life and dispensing of the substance through the one-way valve. 20. A method as defined in claim 18, further comprising aseptically filling the storage chamber with the substance comprising one or more of a substantially preservative free vaccine, a medicine, a pharmaceutical product, a food or a beverage. 21. A method as defined in claim 18, wherein the storage chamber is a variable-volume storage chamber. 22. A method as defined in claim 18, wherein the storage chamber is defined by a container that is semi-rigid or flexible. 23. A method as defined in claim 18, wherein the storage chamber is defined by a flexible pouch or bladder. 24. A method as defined in claim 18, further comprising: dispensing the substance from the storage chamber through the valve, andflowing the one or more of air or other gas into the storage chamber through the filter, and thereby sterilizing the one or more of air or other gas and maintaining any substance remaining in the storage chamber in an aseptic condition. 25. A method as defined in claim 24, further comprising preventing ingress of the one or more of air other gas, or micro-organisms or other contaminants into the storage chamber during the dispensing of the substance through the valve. 26. A method as defined in claim 24, wherein the dispensing step further comprises pressurizing the substance at the inlet to the valve opening, and thereby causing the valve portion to move to the open position. 27. A method as defined in claim 26, wherein the pressurizing step comprises squeezing an engageable portion of the apparatus and thereby pumping the substance into the inlet of the one-way valve and through the one-way valve. 28. A method as defined in claim 27, wherein the engageable portion is comprised of an elastic material that is normally biased toward a ready position and which, when squeezed, is configured to create an elastic spring force sufficient to restore the engageable portion to the ready position; and wherein the squeezing step comprises creating said elastic spring force, and wherein the method further comprises releasing the engageable portion and thereby allowing the elastic spring force to restore the engageable portion to the ready position. 29. A method as defined in claim 27, wherein the engageable portion is manually engageable, and the squeezing step comprises manually engaging the manually engageable portion. 30. A method as defined in claim 29, wherein the manually enagageable portion includes an actuator, and the squeezing step comprises depressing the actuator to thereby pump substance into the inlet of the one-way valve and through the one-way valve. 31. A method as defined in claim 18, wherein the valve portion defines a dimension that is less than a dimension of the valve seat to form an interference fit with the valve seat in at least one location where the valve portion overlies the valve seat. 32. A method as defined in claim 31, wherein one or more of (i) the valve portion and valve seat define a decreasing degree of interference therebetween in a direction from an upstream end toward a downstream end of the valve opening, (ii) the valve portion defines a decreasing radial thickness when moving in a direction from an upstream end toward a downstream end of the valve opening, or (iii) the valve portion and valve seat define a configuration such that energy required to open respective segments in the valve portion progressively decreases in a direction from an upstream end toward a downstream end of the valve opening. 33. A method comprising the following steps: (1) storing multiple portions of a substance in an aseptic condition in a device comprising (i) a storage chamber; (ii) a one-way valve including a valve seat and a valve portion formed of an elastic of flexible material overlying the valve seat, the valve portion and the valve seat defining a normally closed valve opening therebetween, and an inlet to the valve opening in fluid communication with the substance from the storage chamber, wherein the valve portion defines a dimension that is less than a dimension of the valve seat to form an interference fit with the valve seat in at least one location where the valve portion overlies the valve seat, wherein the valve portion is movable relative to the valve seat between a normally closed position with the valve portion engaging the valve seat, and an open position with at least a segment of the valve portion spaced away from the valve seat to allow passage of the substance from the storage chamber through the valve opening, wherein in the normally closed and open positions the one-way valve prevents one or more of air other gas, or micro-organisms or other contaminants from ambient atmosphere from flowing into the storage chamber through the valve, and (iii) a filter coupled in fluid communication between the storage chamber and ambient atmosphere configured to allow the one or more of air or other gas to flow therethrough into the storage chamber after dispensing of the substance through the one-way valve, and to sterilize the one or more of air or other gas flowing into the storage chamber through the filter; and(2) maintaining the substance in the storage chamber in an aseptic condition during a shelf life and dispensing of the substance through the one-way valve. 34. A method as defined in claim 33, further including a penetrable and resealable portion in fluid communication with the storage chamber for introducing the substance into the storage chamber, wherein the penetrable and resealable portion and the filter are in fluid communication with the storage chamber at an opposite side thereof relative to the one way valve. 35. A method as defined in claim 34, further comprising penetrating the penetrable and resealable portion with a needle, filling, or injection member, introducing the substance into the storage chamber, and hermetically resealing a penetration aperture in the penetrable and resealable portion resulting from said penetration of the needle, filling, or injection member. 36. An apparatus comprising: a storage chamber for aseptically storing therein multiple portions of a substance; anda one-way valve including a valve seat and a valve portion overlying the valve seat formed of an elastic or flexible material, the valve seat and valve portion defining a normally-closed valve opening therebetween, wherein the valve portion defines a dimension that is less than a dimension of the valve seat to form an interference fit with the valve seat in at least one location where the valve portion overlies the valve seat, and an inlet to the valve opening connected or connectible in fluid communication with the substance from the storage chamber, wherein the valve portion is movable between (i) a normally closed position with the valve portion engaging the valve seat, and (ii) an open position with at least a segment of the valve portion spaced away from the valve seat to allow passage of the substance from the storage chamber through the valve opening, wherein in the normally closed and open positions the one-way valve prevents one or more of air or other gas, or micro-organisms or other contaminants from ambient atmosphere from flowing into the storage chamber through the valve;and a filter coupled in fluid communication between the storage chamber and ambient atmosphere configured to allow the one or more of air or other gas to flow therethrough into the storage chamber after dispensing of the substance therefrom, and to sterilize the one or more of air or other gas flowing into the storage chamber through the filter. 37. An apparatus as defined in claim 36, further including a penetrable and resealable portion in fluid communication with the storage chamber for introducing substance into the storage chamber, wherein the penetrable and resealable portion and the filter are in fluid communication with the storage chamber at an opposite side thereof relative to the one way valve. 38. An apparatus as defined in claim 36, wherein one or more of (i) the valve portion and valve seat define a decreasing degree of interference therebetween in a direction from an upstream end toward a downstream end of the valve opening, (ii) the valve portion defines a decreasing radial thickness when moving in a direction from an upstream end toward a downstream end of the valve opening, or (iii) the valve portion and valve seat define a configuration such that the energy required to open respective segments in the valve portion progressively decreases in a direction from an upstream end toward a downstream end of the valve opening.
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이 특허에 인용된 특허 (138)
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