Abstract:
An assaying device for collecting, storing, and assaying fluid samples includes a container and a cap. Disposed within the cap is a chamber for housing an assay testing system. A flow channel is provided for communicating between the container and the testing system and enabling the fluid samples to be introduced to the testing system from the container upon change of orientations of the device. A tamper-proof flow control valve and a key are provided for regulating the flow of the fluid sample in the flow channel, thereby, the assaying can be activated only when desired by an authorized person with the key.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of priority under 35 U.S. Code §119 of German Patent Application Number 202007004797.5, filed on Mar. 30, 2007 by the present inventor. 
       FEDERALLY SPONSORED RESEARCH 
       [0002]    None 
       SEQUENCE LISTING OR PROGRAM 
       [0003]    None 
       FIELD OF THE INVENTION 
       [0004]    The present invention generally relates to an assaying device and more specifically relates to assay devices for testing the presence of chemical or hormonal constituents in fluid samples, such as human urine. 
       BACKGROUND OF THE INVENTION 
       [0005]    To achieve minimal handling of the fluid samples by a technician during an in-field screening and testing process, prior arts have developed convenient in-field assaying devices where fluid collection containers and assay testing systems were integrated into a single unit, and a flow channel in the unit communicates between the container and the testing system enabling the fluid samples to be introduced to the testing system from the container, such as upon a change of orientation of the container, eliminating the need for the technician to pipette the fluid samples from a collection container into a separate device that houses the testing system. 
         [0006]    Generally, the testing systems for an in-field screening and testing process utilize test results that manifest chromatographic test results for ease of observing the results in the fields. The assay runs automatically once the fluid samples are introduced to the testing systems. As it would be appreciated by those skilled in the art, the ability to control the exact lapse of time of the test is required in order to ascertain accurate readings of a chromatographic test result. However, sometimes, this ability is frustrated by the fluid samples&#39; donors, because following the collection of the fluid samples, the donors can, accidentally or intentionally, introduce the fluid samples into the testing systems and do not relinquish the assaying device to the technicians after substantial time has been elapsed, and in which case, the technicians have no way of ascertaining the exact lapse of time for the test in order to obtain an accurate test result. As such, it is highly desirable to have a tamper-proof in-field assaying device where the testing system can only be activated by a technician, and cannot be activated by a donor; thus, the technician can measure the accurate lapse of time of the test. 
         [0007]    The present invention provides a tamper-proof regulator in the flow channel of the device that can seal and unseal the testing system from the fluid sample collection container by a specifically designed key, whereby a person without the key, such as the donor, cannot unseal the testing system from the fluid samples and activate the assaying. 
         [0008]    Still further objects and advantages will become apparent from a consideration of the ensuing description and drawings. 
       SUMMARY OF INVENTION 
       [0009]    The present invention is an assay device for collection of fluid samples and testing chemical or hormonal constituents in the fluid samples. The assay device generally includes a container for collecting the fluid samples and a cap for sealing the container. A testing chamber having an assay testing system is disposed in the cap. An opening is also disposed in the cap between the testing chamber and the container defines a flow channel for the fluid samples to be introduced to the testing chamber. The testing system preferably comprises at least one test strip element having reagents suitable for chemical or immunological reaction with specific detecting substances, such as marijuana metabolites or phenocyclidine (PCP) and capable of manifesting chromatographic results. 
         [0010]    A flow control valve is disposed in the flow channel as a regulator for the flow channel, so that when the flow control valve is closed, the flow channel is sealed and no fluid samples can flow from the container to the testing chamber or vice versa. The device is tamper-proof in that the flow control valve can be opened or closed only with a specifically designed key. 
         [0011]    If the assaying were not performed immediately following the collection of the fluid samples, later during the assaying, a negative pressure created by the cooling of warm sample fluids in a sealed container can interfere with the flow of the fluid samples into the testing chamber. The device in accordance with the present invention therefore further includes an air flow path, or an air vent, disposed in the cap for enabling ambient air to flow into the container, and the ingress of the ambient air can equalize any negative pressure that was formed in the container due to the cooling of the fluid samples. Furthermore, in the device in accordance with the present invention, a vent control valve is disposed in the air flow path to regulate the flow of the ambient air. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    The present invention and the objects and advantage thereof will become more obvious from the following description when taken in light with the accompanying drawings wherein like reference numerals denote like elements and in which: 
           [0013]      FIG. 1  is an exploded perspective view of the device for collecting and analyzing fluid samples in accordance with the present invention generally showing a container and a cap, which comprises a base and a cover. 
           [0014]      FIG. 2  is a perspective view of a base with valves. 
           [0015]      FIG. 3  is a perspective view of a base with a testing system disposed in a testing chamber. 
           [0016]      FIG. 4(   a ) is a perspective view of a valve. 
           [0017]      FIG. 4(   b ) is a cross-sectional view of a valve, taken across line  2 - 2  of  FIG. 4(   a ). 
           [0018]      FIG. 5(   a ) is a cross-sectional view showing a flow control valve disposed inside a flow channel and rotated to an open position. 
           [0019]      FIG. 5(   b ) is a cross-sectional view showing a flow control valve disposed inside a flow channel and rotated to a close position. 
           [0020]      FIG. 6  is a cross-sectional view showing a vent control valve disposed inside an air flow path and rotated to an open position. 
           [0021]      FIG. 7(   a ) is a bottom perspective view of a key. 
           [0022]      FIG. 7(   b ) is a top perspective view of a key with a valve. 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    Turning to  FIG. 1 , an example of an assaying device  10  for collecting and analyzing body fluid samples, in accordance with the present invention, is shown. The device generally comprises a container  20  and a cap  50 . The container  20  generally includes an opening  21  which provides a means for collecting the fluid samples in an interior space  22  of the container  20 . Screw threads  23  are disposed in the container  20  proximate to the opening  21  for accepting the cap  50  and sealing the container  20 . In the illustrated embodiment, the container  20  has a rotationally symmetric body, which may be formed from any suitable material, such as plastic. 
         [0024]    The cap  50  comprises of a base  30  and a cover  40 . The base  30  comprises an elongated air-vent opening  31  for enabling the ingress of ambient air into the container  20 . The base  30  further comprises a testing chamber  32  for housing a testing system to assay the fluid samples. The testing chamber  32  comprises of a chamber rim  33  defining the test chamber  32 . The testing chamber  32  further comprises a sloped plenum  34 , or a depression, at a first end. An elongated opening  35  is disposed at the bottom of the plenum  34 . When the cap  50  is engaged to the container  20 , the elongated opening  35  defines a flow channel that communicates between the container  20  and the testing chamber  32  enabling the fluid samples to be deposited to the plenum  34  from the container  20 . 
         [0025]    As hereinafter described in more detail, a regulator can be disposed in the flow channel to regulate the flow of the fluid samples. In the illustrated embodiment in  FIG. 2 , a flow control valve  36  can be disposed in the opening  35  as the regulator for regulating the flow of the fluid samples in the flow channel. The flow channel can be closed or opened by closing or opening the flow control valve  36  as hereinafter described in more detail. Also illustrated in  FIG. 2 , a vent control valve  37  can be disposed in the air-vent opening  31  for regulating the flow of ambient air into the container  20 . 
         [0026]    As shown in  FIG. 3 , a testing system can be disposed in the testing chamber  32  for assaying the fluid samples. As hereinafter described in more detail, when the device  10  is tilted toward the plenum  34 , the fluid samples can be introduced from the container  20  to the plenum  34  through the flow channel as defined by the elongated opening  35 , and the fluid samples deposited in the plenum  34  can be chemically or immunologically reacted with the testing system providing observable chromatographic results for indicating a presence or absence of detecting substances in the fluid samples. 
         [0027]    Returning to  FIG. 1 , the cover  40  may be permanently fixed to the base  30  after the testing system is laid down in the testing chamber  32 . The cover  40  may be formed from any suitable material, such as plastic, but preferably, the material is transparent for ease of observing the chromatographic test results. The means to fix the cover  40  to the base  30  are not described in detail herein, as such details are well known and are not considered a part of the present invention. A portion of the cover  40  overlaying the testing chamber  32  also defines a top wall of the testing chamber  32 . Preferably, the cover  40  is sonically welded with the chamber rim  33  to provide a tight seal especially, between the plenum  34  and the cover  40 . 
         [0028]    The cover  40  further comprises a first opening  41  and a second opening  42 , wherein the second opening  42  has a notch  43 . When the cover  40  is fixed to the base  30 , the positions of the first opening  41  and the second opening  42  align with the positions of the opening  35  and the air-vent opening  31  respectively, which are required for operating the flow control valves  36  and the vent control valve  37  ( FIG. 2 ) after the cover  40  is fixed to the base  30 . 
         [0029]    Referring now to  FIG. 3 , generally, the testing system includes test strips  26 , wick materials  27  for introducing the fluid samples to the test strips  26  and the wick materials  28  for facilitating permeation of the fluid samples in the test strips  26 . In operation, the plenum  34  acts as a reservoir for the fluid samples to be tested. The fluid samples are first deposited in the plenum  34 . The fluid samples deposited in the plenum  34  then becomes absorbed by the wick materials  27  and begin migrating through the test strips  26  by capillary action. The test strips  26  provide for chromatographical means for indicating a presence or absence of a specific detecting substance in the fluid samples. The functionality of the test strips and the assembly of the testing system are not described in detail herein, as such details are well known and are not considered a part of the present invention. 
         [0030]    The testing chamber  32  further comprises a plurality lower limiting elements  47 , which partially define the plenum  34 , and a plurality upper limiting elements  48 . The plurality test strips  26  may be separated from one another by disposing one end of the test strips  26  between the upper limiting elements  48  and the other ends between the lower limiting elements  47 . While four test strips are shown, a greater or smaller number of individual strips may be utilized by increasing or decreasing the corresponding numbers of lower limiting elements  48  and upper limiting elements  47 , thus any number of concurrent tests for detecting substances may be performed with the device of the present invention. Furthermore, when the fluid samples were deposited into the plenum  34 , the lower limiting elements  47 , in cooperation with the cover  40 , prevents the escape of the fluid samples from the plenum  34  to the other parts of the testing chamber  32  except through the wick materials  27  and the test strips  26 . 
         [0031]    Same type of valve can be used for the flow control valve  36  and the vent control valve  37 .  FIG. 4(   a ) shows an embodiment of a valve  60  as used for the flow control valve  36  and the vent control valve  37 . The valve  60  is preferably cylindrically shaped and can be rotated. As shown in  FIG. 4(   b ), a cross-sectional view of the valve, the valve  60  comprises an actuating element  62  at a first end, and a right angled bore  63  having a first opening  64  at a first end and a second opening  65  at a second end. 
         [0032]    Referring now to  FIG. 5(   a ), the opening  35  comprises a flange  39  at a first end that extends laterally inward for holding the flow control valve  36  inside the opening  35 . When a same type of valve as the valve  60  is used for the flow control valve  36 , the flow control valve  36  comprises a flow valve actuating element  62   a  and a first opening  64   a  and a second opening  65   a.  As the valve  36  is rotated to an open position, the second opening  65   a  faces the plenum  34  that establishes a flow path for the fluid samples to flow from the container  20 , through the first opening  64   a  and then the second opening  65   a,  and into the plenum  34  as indicated by an arrow  3 . As shown in  FIG. 5(   b ), when the flow control valve  36  is rotated to a closed position, the second opening  65   a  is blocked by the inner wall of the elongated opening  35 , thus preventing the flow of the fluid samples from the container  20  to the plenum  34 . 
         [0033]    As shown in  FIG. 6 , the air-vent opening  31  comprises a flange  69  at a first end that extends laterally inward for holding a valve inside the air-vent opening  31 . The air-vent opening  31  further comprises a notch  68  formed from the flange  69  to the top of the base  30  that partially defines an air flow path for ambient air flow into the container  20 . As noted above, the same type of valve  60  can be used for the vent control valve  37 . When a same type of valve as the valve  60  is used for the vent control valve  37 , the vent control valve  37  comprises a vent valve actuating element  62   b  and a first opening  64   b  and a second opening  65   b.  As the valve  37  is rotated to an open position, the second opening  65   b  aligns with the notch  68  which establishes the air flow path enabling the ambient air to flow into the container  20  through the notch  68  and via the second opening  65   b  and the first opening  64   b,  as indicated by an arrow  5 . When the valve  37  is rotated to a closed position, the second opening  65   b  misaligns with the notch  68  and faces the inner wall of the air-vent opening  31 , and is blocked by the inner wall of the air-vent opening  31 , thus preventing the flow of the ambient air to the container  20 . 
         [0034]    In the illustrated embodiment, the flow control valve  36  and the vent control valve  37  can be opened or closed by rotating the valves. The valves can be rotated by means of an actuation key.  FIG. 7(   a ) shows an embodiment of the actuation key  70 . The actuation key  70  comprises a projection element  71 . The projection element  71  can be designed with the complementary shape of the depression of the actuating element  62  of the valve  60 , and thereby, the key  70  can be engaged with the valve  60  by inserting the projection element  71  into the actuating element  62 , as best illustrated in  FIG. 7(   b ). The valve  60  then can be rotated by turning the key  70 . When the same type of valve  60  is used for both the flow control valve  36  and the vent control valve  37 , the flow control valve  36  and the vent control valve  37  can be rotated by using the key  70 . 
         [0035]    The key  70  further comprises a protruding heel  72  ( FIG. 7(   a )). Referring to  FIG. 1 , the first opening  41  and the second opening  42  further comprise depressions  44  and  45  respectively, which are shaped like an arc, or circular ring sections. When the key  70  is inserted in the flow control valve  36 , the heel  72  will be automatically engaged, or inserted, into the depression  44 , and likewise when the key  70  is inserted in the vent control valve  37 , the heel  72  will be automatically engaged, or inserted, into the depression  45 . Because the heel  72  can only move within the range of the arcing distance of the depression, the depression  44  or  45  thereby delimits the rotational range of the key  70 . Delimiting the rotation of the key  70 , in turn delimits the rotational ranges of the flow control valve  36  and the vent control valve  37 . The placement and the arcing distance of the depression can be coordinated so that when the heel  72  is at one end of the depression, the valve assumes an open position and when at another end, the valve assumes a close position; thereby, it can assist a technician to accurately locate the open and close positions of the valves. 
         [0036]    The operation of the present invention with the above embodiments is as follows: prior to collecting the fluid samples, the flow control valve  36  and the vent control valve  37  are closed. The closure of the flow control valve  36  seals the testing chamber  32  and prevents tampering with the testing system, such as by prematurely introducing the fluid samples into the testing chamber. After the fluid samples are collected in the container  20 , the cap  50  is screwed tightly onto the container  20 . The fluid samples then can be tested in the field immediately following the collection or stored in a suitable storage environment, such as a refrigerator, and tested later. 
         [0037]    When desired to test the sample fluid, the flow control valve  36  and the vent control valve  37  are opened by inserting the actuating key  70  and rotating the valves to open positions. The device  10  is tilted toward the plenum  34  until the plenum  34  is filled with the fluid samples. When the plenum  34  is filled with the fluid samples, the flow control valve  36  and the vent control valve  37  are closed by rotating the valves with the actuating key  70  to the close position. The device  10  is then brought to its upright position. 
         [0038]    The closure of the flow channel immediately after the fluid samples are deposited in the test chamber  32  provides an important function in that it prevents the backward flow of the fluid samples that may have already chemically or immunologically interacted with the reagents in the test strips  26 . Prevention of the backflowing substantially eliminates the fluid samples that have interacted with the reagents from contaminating the remaining fluid samples in the container  20 . In so doing, it preserves the integrity of the fluid samples remaining in the container  20  for any further testing. 
         [0039]    The test begins to run automatically as the sample fluids migrate through the wick materials  27  and permeate through the test strips  26 . The technician can observe the chromatograph test results on the test strips  26  through the cover  40 . If any of the results are positive, the remaining fluid samples in the container can be sent to a certified laboratory for further testing. 
         [0040]    Although there has been hereinabove described an assaying device in accordance with the present invention, for the purpose of illustrating the manner in which the invention may be used to advantage, it should be appreciated that the invention is not limited thereto. Accordingly, any and all modifications, variations, or equivalent arrangements which may occur to those skilled in art, should be considered to be within the scope of the present invention as defined in the appended claims.