IPC분류정보
국가/구분 |
United States(US) Patent
등록
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국제특허분류(IPC7판) |
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출원번호 |
US-0764624
(2004-01-26)
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발명자
/ 주소 |
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출원인 / 주소 |
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대리인 / 주소 |
Cook, Alex, McFarron, Manzo, Cummings &
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인용정보 |
피인용 횟수 :
20 인용 특허 :
36 |
초록
▼
Presteralized manifolds are provided which are designed for sterile packaging and single-use approaches. Disposable tubing and flexible-wall containers are assembled via aseptic connectors. These manifolds interact with at least one remotely controlled pinch valve which engages only the outside surf
Presteralized manifolds are provided which are designed for sterile packaging and single-use approaches. Disposable tubing and flexible-wall containers are assembled via aseptic connectors. These manifolds interact with at least one remotely controlled pinch valve which engages only the outside surface of the manifold tubing. Such manifold and pinch valve systems can be used in conjunction with a peristaltic type of pump, which, together with the remotely operated pinch valve, can be operated by a controller which provides automated and accurate delivery of biotechnology fluid in an aseptic environment while avoiding or reducing cleaning and quality assurance procedures.
대표청구항
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The invention claimed is: 1. A manifold system for biotechnology uses, comprising: a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including: (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, a
The invention claimed is: 1. A manifold system for biotechnology uses, comprising: a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including: (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough, (b) at least one single-use bag having a primary access port, and (c) an aseptic connector means for operatively connecting said length of tubing with said primary access port of the single-use bag; and a plurality of pinch valves, at least one of which is remotely operable in response to a signal remote from said pinch valve, each said pinch valve engages said outside surface of the length of tubing at a discrete location therealong, each said pinch valve independently selectively allowing or stopping flow of the biotechnology fluid through said inside surface of the length of tubing at said discrete location for that pinch valve. 2. The manifold system in accordance with claim 1, wherein said primary access port of the single-use bag includes a shut-off clamp. 3. The manifold system in accordance with claim 1, wherein said single-use bag further includes access port means for releasing gas or pressure build-up from said bag. 4. The manifold system in accordance with claim 1, wherein said single-use bag further includes an auxiliary access port. 5. The manifold system in accordance with claim 1, wherein said single-use bag further includes access port means for releasing gas or pressure build-up from said bag and further includes an auxiliary access port. 6. The manifold system in accordance with claim 5, further including a shut-off clamp for said access port means and for said auxiliary access port. 7. The manifold system in accordance with claim 1, further including a singleuse sterilizing filter positioned along said length of tubing such that the biotechnology fluid flows therethrough at a location upstream of said outlet and portion. 8. The manifold system in accordance with claim 1, wherein said system is for automated aseptic fluid transfer, wherein said outlet end portion of the tubing has a plurality of serially arranged outlet passageways having one of said aseptic connector means for operable connection with said single-use bag, and wherein each said pinch valve controls passage of the biotechnology fluid from the tubing to the single-use bag. 9. The manifold system in accordance with claim 8, further including a single-use sterilizing filter positioned along said length of tubing such that the biotechnology fluid flows therethrough at a location upstream of said outlet end portion. 10. The manifold system in accordance with claim 8, further including a disposable pressure sensor positioned along said length of tubing such that the biotechnology fluid flows therethrough at a location upstream of said outlet end portion. 11. The manifold system in accordance with claim 9, further including a disposable pressure sensor positioned along said length of tubing such that the biotechnology fluid flows therethrough at a location downstream of said sterilizing filter and upstream of said outlet end portion. 12. A manifold system for biotechnology uses, wherein said system is for automated, aseptic fluid transfer, comprising: a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including: (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough, (b) a plurality of single-use bags, each having a primary access port, (c) aseptic connector means for operatively connecting said length of tubing with said primary access port of at least one of said single-use bags, and (d) said outlet end portion of the tubing has a plurality of serially arranged outlet passageways having one of said aseptic connector means for operable connection with said single-use bag; and a plurality of pinch valves, at least one of which is remotely operable in response to a signal remote from said pinch valve, each said pinch valve engages said outside surface of the length of tubing at a discrete location therealong, each said pinch valve independently selectively allowing or stopping flow of the biotechnology fluid through said inside surface of the length of tubing at said discrete location for that pinch valve, and wherein each said pinch valve controls passage of the biotechnology fluid from the tubing to each said single-use bag. 13. The manifold system in accordance with claim 12, further including a singleuse sterilizing filter positioned along said tubing such that the biotechnology fluid flows therethrough at a location upstream of said outlet passageways. 14. The manifold system in accordance with claim 13, further including a disposable pressure sensor positioned along said tubing such that the biotechnology fluid flows therethrough at a location downstream of said sterilizing filter and upstream of said outlet passageways. 15. The manifold system in accordance with claim 12, further including a disposable pressure sensor positioned along said tubing such that the biotechnology fluid flows therethrough at a location upstream of said outlet passageways. 16. The manifold system in accordance with claim 12, wherein said primary access port of the single-use bag includes a shut-off clamp. 17. The manifold system in accordance with claim 12, wherein said singleuse bag further includes access port means for releasing gas or pressure build-up from said bag. 18. The manifold system in accordance with claim 12, wherein said singleuse bag further includes an auxiliary access port. 19. The manifold system in accordance with claim 12, wherein said singleuse bag further includes access port means for releasing gas or pressure build-up from said bag and further includes an auxiliary access port. 20. The manifold system in accordance with claim 19, further including a shut-off clamp for said access port means and for said auxiliary access port. 21. A manifold and pump system for biotechnology uses, comprising: a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including: (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough, (b) at least one single-use bag having an access port, and (c) an aseptic connector means for operatively connecting said length of tubing with said access port of the single-use bag; a plurality of pinch valves, at least one of which is remotely operable in response to a signal remote from said pinch valve, each said pinch valve engages said outside surface of the length of tubing at a discrete location therealong, each said pinch valve independently selectively allowing or stopping flow of the biotechnology fluid through said inside surface of the length of tubing at said discrete location for that pinch valve; and a pump unit which engages said outside surface of the length of tubing at a selected location upstream of said discrete location for the pinch valve. 22. The manifold and pump system in accordance with claim 21, further including a controller which controls operation of said pump unit and of said pinch valve. 23. The manifold and pump system in accordance with claim 22, wherein said controller is a programmable unit. 24. The manifold and pump system in accordance with claim 22, wherein said controller is programmable and is included in said pump unit. 25. The manifold and pump system in accordance with claim 21, wherein said pinch valve is pneumatically operated. 26. The manifold and pump system in accordance with claim 21, wherein said pinch valve is electronically operated. 27. A manifold and pump system for biotechnology uses, wherein said system is for automated, aseptic fluid transfer, comprising: a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including: (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough, (b) a plurality of single-use bags, each having an access port, (c) aseptic connector means for operatively connecting said length of tubing with said access port of at least one of said single-use bags, and (d) said outlet end portion of the tubing has a plurality of serially arranged outlet passageways having one of said aseptic connector means for operable connection with said single-use bag; a plurality of pinch valves, at least one of which is remotely operable in response to a signal remote from said pinch valve, each said pinch valve engages said outside surface of the length of tubing at a discrete location therealong, each said pinch valve independently selectively allowing or stopping flow of the biotechnology fluid through said inside surface of the length of tubing at said discrete location for that pinch valve, and wherein each said pinch valve controls passage of the biotechnology fluid from the tubing to each said single-use bag; and a pump unit which engages said outside surface of the length of tubing at a selected location upstream of said discrete location for the pinch valve. 28. An automated manifold and pump system for biotechnology uses, comprising: a manifold unit which is pre-sterilized and disposable so as to be adapted for single-time usage, including: (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough, (b) at least one single-use bag having an access port, and (c) an aseptic connector means for operatively connecting said length of tubing with said single-use bag; a plurality of pinch valves, at least one of which is remotely operable, and each said pinch valve engages said outside surface of the length of tubing; a pump unit which engages said outside surface of the length of tubing at a selected location upstream of said pinch valve; and a controller which controls operation of said pump unit and of said pinch valve, said controller having control logic which dictates the timing of opening and closing of said remotely operable pinch valve. 29. The automated system in accordance with claim 28, wherein said control logic of the controller determines the extent of filling of the single-use bag by processing data monitored by the system to achieve filling of the single-use bag by volume, by weight, or by pump rate and filling time. 30. The automated system in accordance with claim 28, wherein said control logic of the controller dictates the rate of pumping of said pump unit. 31. An automated manifold and pump system for biotechnology uses, wherein said system is for automated, aseptic fluid transfer, comprising: a manifold unit which is pre-sterilized and disposable so as to be adapted for single time usage, including: (a) at least one length of tubing having at least one inlet end portion, at least one outlet end portion, an outside surface, and an inside surface which is sterilized for passage of a biotechnology fluid therethrough, (b) a plurality of single-use bags, each having an access port, (c) an aseptic connector for operatively connecting said length of tubing with said access port of at least one of said single-use bags, and (d) said outlet end portion of the tubing has a plurality of serially arranged outlet passageways having one of said aseptic connectors for operable connection with said single-use bag; a plurality of pinch valves, at least one of which is remotely operable, and each said pinch valve engages said outside surface of the length of tubing at a discrete location therealong and controls passage of the biotechnology fluid from the tubing to each said single-use bag; a pump unit which engages said outside surface of the length of tubing at a selected location upstream of said discrete location for the pinch valve; and a controller which controls operation of said pump unit and of said pinch valve, said controller having control logic which dictates the timing of opening and closing of said remotely operable pinch valve. 32. The automated system in accordance with claim 31, wherein said control logic of the controller dictates the rate of pumping of said pump unit. 33. The automated system in accordance with claim 31, wherein said control logic of the controller determines the extent of filling of the single-use bag by processing data monitored by the system to achieve filling of the single-use bag by volume, by weight, or by pump rate and filling time. 34. The automated system in accordance with claim 31, wherein said control logic activates pumping action of said pump unit and opens a first remotely operable pinch valve for a length of time needed to pump a selected volume or weight of biotechnology fluid into a first said single-use bag associated with said first remotely operable pinch valve, wherein said control logic activates pumping action of said pump unit and opens a second remotely operable pinch valve for a length of time needed to pump a selected volume or weight of biotechnology fluid into a second said single-use bag associated with said second remotely operable pinch valve, and wherein said control logic activates pumping action of said pump unit and opens a further remotely operable pinch valve for a length of time needed to pump a selected volume or weight of biotechnology fluid into a further said single-use bag associated with said second remotely operable pinch valve until a user-selected number of singleuse bags are filled. 35. The automated system in accordance with claim 31, wherein said control logic activates pumping action of said pump unit and opens a first remotely operable pinch valve for a length of time needed to pump a selected volume or weight of biotechnology fluid into a first said single-use bag associated with said first remotely operable pinch valve, and wherein said control logic activates pumping action of said pump unit and opens a further remotely operable pinch valve for a length of time needed to pump a selected volume or weight of biotechnology fluid into a further said single-use bag associated with said second remotely operable pinch valve until a user-selected number of single-use bags are filled.
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