The present invention relates broadly to fluid control devices and methods for introducing or withdrawing a fluid into or from a container. More specifically, the present invention concerns a device and method for aseptically or non-aseptically accessing a fluid in a container, such as a large-volume tank, using an existing container opening.
It is often desirable to sample a fluid in a container. While containers often include valves or other simple mechanisms for accessing the fluids, these simple mechanisms do not allow for maintaining the fluids and/or the interiors of the containers in aseptic or otherwise controlled conditions.
Furthermore, while more complex mechanisms are known in the art which allow for accessing the fluids while maintaining the controlled conditions, these mechanisms require substantial machining of the containers, including, in some cases, the creation of additional openings in the containers. One such mechanism, for example, involves creating an additional opening in the container, welding a fitting over the opening, and installing a septum in the fitting so that thereafter the fluid can be accessed by using a needle to penetrate the septum. It will be appreciated that such additional machining is undesirably laborious and time-consuming, and that the additional openings undesirably provide additional points through which the controlled conditions may be compromised.
Due to these and other problems and limitations, an improved device and method is needed for accessing fluid in a container.
The present invention overcomes the above-described and other problems and limitations in the prior art by providing a device and method for aseptically or non-aseptically accessing a fluid in a container, such as a large-volume tank, using an existing container opening.
In one embodiment, the device broadly comprises a sanitary fitting for attaching the device to the container over the existing container opening, and a sample coupling associated with the sanitary fitting. The sanitary fitting includes a first port, and the sample coupling includes at least two second ports. The sample coupling is rotatable relative to the sanitary fitting in one direction to cause the first port to successively align with each of the second ports, and thereby allows access to the fluid through the aligned first and second ports.
The device may further include, for each of the second ports, a nipple associated with the second port, a sample container for receiving the fluid flowing through the aligned first and second ports, and tubing extending between the nipple and the sample container. The second port, nipple, sample container, and tubing may be pre-sterilized. The device may further include one or more clamps operable to control the flow of the fluid through the tubing. The device may further include a plurality of teeth operable to allow the sample coupling to rotate relative to the sanitary fitting in the one direction and to prevent relative rotation in an opposite direction. The device may further include a stop structure for stopping rotation of the sample coupling relative to the sanitary fitting when one of the second ports is aligned with the first port. The device may further include a stop selection mechanism for disengaging the stop structure and allowing rotation of the sample coupling relative to the sanitary fitting. The stop structure may also be operable to stop rotation of the sample coupling relative to the sanitary fitting when the first port is located at a particular point between adjacent second ports. The device may further include a final stop mechanism operable to prevent rotating the sample coupling relative to the sanitary fitting more than approximately 360 degrees in the one direction. The device may further include a gasket surrounding each of the second ports, and a recess in which the gasket is received, wherein the gasket is interlockingly received in the recess so as to substantially prevent movement of the gasket relative to the second ports. The device may further include a cover operable to retain the sample coupling on the sanitary fitting. The cover may include an opening corresponding to each of the second ports and through which the respective aforementioned nipple projects.
In one embodiment, the method of the present invention broadly comprises the step of removing the aforementioned device, having been pre-sterilized, from an airtight packaging, attaching the sanitary fitting to the container over the existing container opening such that substantially no additional machining of the container is necessary to attach the device, sterilizing an inside of the container and, in so doing, an inside of the sanitary fitting, and placing the fluid inside the container. The method includes, when it is desired to sample the fluid, the step of rotating the sample coupling relative to the sanitary fitting in the one direction until the first port aligns with one of the second ports, and capturing the fluid flowing through the aligned first and second ports.
The method may further include, when it is desired to stop sampling the fluid, the step of rotating the sample coupling relative to the sanitary fitting in the one direction until the first port is no longer aligned with the one of the second ports. The method may further include, when it is desired to take a second sample, the step of rotating the sample coupling relative to the sanitary fitting in the one direction until the first port aligns with another a next one of the second ports.
Thus, it will be appreciated that the present invention advantageously allows for conveniently accessing the fluid within the container using an existing container opening, thereby avoiding laborious and time-consuming additional machining of the container and avoiding the creation of an additional point through which the controlled conditions within the container may be compromised.
These and other features of the present invention are described below in more detail in the section titled DETAILED DESCRIPTION OF THE INVENTION, below.
The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present invention. The figures are examples only, and do not limit the scope of the invention. The words “top” and “bottom” are used only to convey relative location or direction, and do not limit the scope of the invention.
With reference to the drawing figures, a device 10 and method is described, shown, and other disclosed in accordance with a preferred embodiment of the present invention. Broadly, the present invention concerns a disposable device and associated method for aseptically or non-aseptically introducing or withdrawing a fluid into or from a container using an opening which is already present in or on the container.
In one potential application, the container is a large-volume tank for producing commercial quantities of the fluid. The fluid may be a liquid, semi-liquid, gel, or paste. Whether a particular application requires aseptic or non-aseptic procedures depends on such factors as the nature of the fluid and the purpose for which the fluid will be used. For example, the present invention may be used to aseptically withdraw a sample of a biological product, such as a reagent from a tank, or to cleanly but non-aseptically withdraw a sample of an ink or drinkable spirit from a tank. As used herein, the term “aseptic” refers to both the fluid and its path through the system being maintained in a substantially sterile condition during the introduction or withdrawal process. The term “aseptic” similarly encompasses the fluid and the path being maintained in an uncontrolled or substantially controlled, but not substantially sterile, condition.
Referring to
Referring also to
The connector projection 36 cooperates with the retainer mechanism 18 to secure the cover 16 and the sample coupling 14 to the sanitary fitting 12. To that end, the connector projection 36 may present first and second grooves 40, or channels, the function of which is described below.
Referring also to
Referring also to
The ratchet arm 48 engages the plurality of ratchet teeth 34, which are inclined in the direction of rotation, in a stepped-rotation ratchet operation, allowing the sample coupling 14 to rotate in one direction relative to the sanitary fitting 12 but not in the opposite direction, thereby preventing returning to a previously used nipple 56 and associated tubing and sample bag, as described below. The plurality of second ports 52 are thereby each alignable, in turn, with the first port 32 when it is desired to introduce or withdraw fluid from the container.
The plurality of stops 54 are each spaced apart from the other and operable to receive or otherwise engage the stop selection mechanism 28 and thereby selectively stop or allow movement of the sample coupling 14 relative to the sanitary fitting 12. Each stop 54 corresponds either to an “open” position, in which the first port 32 is aligned with one of the plurality of second ports 52 such that fluid can flow out of the sanitary fitting 12 and through the sample coupling 14, or a “closed” position in which the first port 32 is not so aligned and therefore none of the fluid can flow out of the sanitary fitting 12 or through the sample coupling 14. In the illustrated embodiment, there are eight such stops 54, i.e., four “open” and four “closed”.
The plurality of nipples 56 each provide a fitting for coupling the device 10 with the tubing or other structure for directing the fluid into or out of the device 10. Each of the nipples 56 is associated with a respective one of the second ports 52 and extends outwardly therefrom. The sample coupling 14 may present knurling or other contouration on its outer gripping surface to facilitate gripping the sample coupling 14 when turning it relative to the sanitary fitting 12 in order to align or not align the first port 32 with one of the second ports 52.
In one embodiment, the tubing is provided extending from each nipple 56 to a sample bag (see
Referring also to
The retainer mechanism 18 engages the connector projection 36 and cover 18 to substantially prevent relative movement therebetween. The retainer mechanism 18 may take the form of first and second clips operable to engage, respectively, the first and second grooves 40, or channels, thereby trapping the cover surface between the clips and substantially preventing movement of the cover 16 relative to the sample coupling 14.
The plurality of surrounding openings 64 each fits over a respective one of the nipples 56, leaving at least an end portion of each nipple 56 accessible. An inner surface of each of the surrounding openings 64 presents a raised portion 66 which asserts a retaining force on the tubing inserted into the surrounding opening 64 and over the nipple 56. The cover 16, once installed, is not movable relative to the sample coupling 14 because one or more peripheral projections 82 in the cover 16 positively engage one or more peripheral recesses 86 in the sample coupling 14 in order to prevent such relative motion. The cover 16 may present knurling or other contouration on its outer gripping surface to facilitate gripping the cover 16 and associated sample coupling 14 when turning the sample coupling 14 relative to the sanitary fitting 12 in order to align or not align the first port 32 with the second ports 52.
Additionally, the device 10 may further include a final stop mechanism for preventing turning the sample coupling 14 more than approximately 360 degrees relative to the sanitary fitting 12 and thereby preventing reuse of a previously used nipple 56. The final stop mechanism includes a locking pin 84 on or near a lower wall surface of the cover 16, a first locking pin opening 88 on or near an upper wall surface of the sample coupling 14, and a second locking pin opening 90 on or near an upper wall surface of the sanitary fitting 12. When the sample coupling 14 and the cover 16 are initially brought together, and the locking projection 84 extends through the first locking pin opening 88, and rides in a groove, or channel provide in the sanitary fitting 12. Once the sample cover 14 and the cover 16 have rotated approximately 360 degrees relative to the sanitary fitting 12, the locking pin 84 aligns with and penetrates the second pin locking opening 90, thereby locking all three components together and preventing any further relative movement therebetween.
In exemplary use and operation, referring also to
Subsequently, when it is desired to sample the contents of the container 210, the stop selection mechanism 28 is disengaged, the sample coupling 14 and cover 16 are turned until the first port 32 aligns with one of the second ports 52, and the stop selection mechanism 28 is engaged with a next one of the stops 54. The fluid then flows from the container 210, through the aligned ports 32,52 in the device 10, through the associated tube 212, and into the associated sample bag 214 or other container. During filling, the pinch clamp 216 provided on the tubing 212 allows for temporarily slowing or stopping the flow of fluid. When finished, the stop selection mechanism 28 is again disengaged, the sample coupling 14 and cover 16 are turned until the first port 32 is aligned with an area between the adjacent second ports 52 such that the first port 32 is sealed, and the stop selection mechanism 28 is engaged with a next one of the stops 54. The cutting clamp 218 can then be used to seal and cut the tubing, thereby allowing the filled sample bag to be removed for testing. The process can be repeated as many times as there are nipples 56 and associated tubes 212 and sample bags 214.
Thus, it will be appreciated that the present invention advantageously allows for conveniently accessing the fluid within the container using an existing container opening, thereby avoiding laborious and time-consuming additional machining of the container and avoiding the creation of an additional point through which the controlled conditions within the container may be compromised.
Although the invention has been disclosed with reference to various particular embodiments, it is understood that equivalents may be employed and substitutions made herein without departing from the scope of the invention as recited in the claims.
The present non-provisional patent application is related to and claims priority benefit of an earlier-filed provisional patent application titled “Device and Method for Fluid Sampling”, Ser. No. 60/803,410, filed May 30, 2006. The identified earlier-filed application is hereby incorporated by reference into the present application.
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