Abstract:
A method of using a fluid transfer and mixing collection assembly includes depressing a flexible member to cause a force to be imparted to a breakable vial to break the vial, releasing the second fluid therein into an interior of the flexible member; releasing the flexible member to impart a negative pressure in the interior of the flexible member to draw a first fluid into the interior of the flexible member through the inlet check valve to mix with the second fluid; and depressing the flexible member to impart a positive pressure in the interior of the flexible member to pump the mixed first fluid and second fluid out of the interior of the flexible member through an outlet check valve and be transferred to test media.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]    This application claims the benefit of provisional patent application 61/092,948, filed Aug. 29, 2008 under 35 U.S.C. 119(e). This provisional patent application is incorporated by reference herein as though set forth in full. 
     
    
     FIELD OF THE INVENTION  
       [0002]    The present invention is, in general, in the field of fluid-transfer collection assemblies, and, in particular, in the field of fluid transfer and mixing collection assemblies. 
       BACKGROUND OF THE INVENTION  
       [0003]    Collection kits used for testing one or more analytes of a sample include multiple separate components such as a pipettes, collection tubes, vials or ampoules containing needed diluents or reagents, and test media devices. Because these collection kits have so many separate pieces, in most cases, use of such collection kits has been limited to a laboratory. Simple tests may be performed outside of the laboratory using only test media devices, but these test media devices are limited as to the types of tests that can be performed. More elaborate tests require diluents, pipettes, collection tubes, etc., and are difficult and awkward to perform outside of the laboratory. 
         [0004]    Accordingly, a need exists for a simple fluid transfer and mixing collection assembly that does not include numerous separate pieces, is easy to use, can be used for multiple different types of tests and can be used in and outside a laboratory. 
       SUMMARY OF INVENTION  
       [0005]    Accordingly, an aspect of the invention involves a fluid transfer and mixing collection assembly. The collection assembly includes a base, a test media carried by the base, an inlet for receiving a first fluid, the inlet including an inlet check valve, an outlet including an outlet check valve, a glass vial carried by the base between the inlet and the outlet and including an interior with a second fluid therein, and a pair of depressable, flexible members carried on opposite sides of the base between the inlet and the outlet and including an interior with the glass vial disposed therein. The flexible members are depressable to break the glass vial therein, releasable to draw the first fluid into the interior of the flexible members through the inlet check valve to mix with the second fluid from the glass vial, and depressable again to pump the mixed first and second fluids out of the interior of the flexible members through the outlet check valve and be transferred to the test media. 
         [0006]    Another aspect of the invention involves a method of using a fluid transfer and mixing collection assembly. The method includes providing a fluid transfer and mixing collection assembly including a base, a test media carried by the base, an inlet for receiving a first fluid, the inlet including an inlet check valve, an outlet including an outlet check valve, a breakable vial carried by the base between the inlet and the outlet and including an interior with a second fluid therein, and a depressable, flexible member carried by the base between the inlet and the outlet, the flexible member including an interior with the breakable vial therein; depressing the flexible member to cause a force to be imparted to the breakable vial to break the vial, releasing the second fluid therein into the interior of the flexible member; releasing the flexible member to impart a negative pressure in the interior of the flexible member to draw the first fluid into the interior of the flexible member through the inlet check valve to mix with the second fluid; and depressing the flexible member to impart a positive pressure in the interior of the flexible member to pump the mixed first fluid and second fluid out of the interior of the flexible member through the outlet check valve and be transferred to the test media. 
         [0007]    A further aspect of the invention involves a fluid transfer and mixing collection assembly. The fluid transfer and mixing collection assembly includes a base; a test media carried by the base; an inlet for receiving a first fluid, the inlet including an inlet check valve; an outlet including an outlet check valve; a breakable vial carried by the base between the inlet and the outlet and including an interior with a second fluid therein, and a depressable, flexible member carried by the base between the inlet and the outlet, the flexible member including an interior with the breakable vial therein, the flexible member depressable to cause a force to be imparted to the breakable vial to break the vial, releasing the second fluid therein into the interior of the flexible member, the flexible member releasable to impart a negative pressure in the interior of the flexible member to draw the first fluid into the interior of the flexible member through the inlet check valve to mix with the second fluid, and the flexible member depressable again to impart a positive pressure in the interior of the flexible member to pump the mixed first fluid and second fluid out of the interior of the flexible member through the outlet check valve and be transferred to the test media. 
         [0008]    Other and further objects, features, aspects, and advantages of the present inventions will become better understood with the following detailed description of the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0009]      FIG. 1  is a perspective view of a fluid transfer and mixing collection assembly constructed in accordance with an embodiment of the invention. 
           [0010]      FIG. 2  is a cut-away perspective view of the fluid transfer and mixing collection assembly. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0011]    With reference to  FIGS. 1 and 2 , an embodiment of a fluid transfer and mixing collection assembly  10 , and method of using the same will now be described. Further below, the collection assembly  10  will be described as an optical assay test device in an optical assay test method; however, the collection assembly  10  may be used in other devices, processes, and applications where mixing of two or more fluids and/or delivery of one or more fluids to a collection area is desired. 
         [0012]    The collection assembly  10  includes a substantially flat, rectangular, elongated, plastic base  20  that carries a bulb pump  30  comprised of a pair of depressable, flexible, domed elastic members  35  carried on opposite sides of the base  20  and a glass vial  40  disposed in an interior of the bulb pump  30 /members  35 . 
         [0013]    Although the bulb pump  30  is shown as being a pair of depressable members located on an upper surface and a bottom surface of the base  20 , and oriented outwardy, away from the base  20 , in alternative embodiments, the bulb pump  30  may be a single depressable member, may be located at other locations on the base  20 , and/or may be oriented in one or more of an upward, a downward, a lateral, a forward, and a rearward direction with respect to the base  20 . Similarly, the glass vial  40  may be located at other locations on the base  20 , oriented differently, and/or fixed/mounted differently. In the embodiment shown, the glass vial has an elongated, narrow, cylindrical configuration. In alternative embodiments, breakable vessels made of other materials (e.g., plastic) and/or having other configurations may be used. 
         [0014]    In the embodiment shown, fluid in an interior  64  of bulb pump  30  is air and fluid in an interior  68  of the vial  40  is one or more chemical reagents or diluents. In alternative embodiments, one or more different types of fluids may be used in the bulb pump  30  and/or the vial  40 . 
         [0015]    The interior  64  of the bulb pump  30  forms a fluid path  69  (formed by interior walls  71 ) between an inlet check valve  70  of an inlet  72  and an outlet check valve  80  of an outlet  82 . The inlet  72  may include an inlet port  90  that communicates with a sample tube  100 . The sample tube  100  may include a proximal end  102  and a distal end  104 . The outlet check valve  80  communicates with one or more test media  110  via one or more fluid paths  120 . One or more vents (not shown) in the collection assembly  10  allow air to escape where needed so that the pumping and fluid transferring action can be performed. 
         [0016]    In the embodiment shown, the one or more test media  110  may include visual indicia to visually indicate the presence, absence, or concentration of a target analyte or other target object(s). The test media  110  may include one or more of the following: base strip(s), sample pad(s), conjugate pad(s), membrane(s), and absorbent pad(s). 
         [0017]    The collection assembly  10  will now be described in use as an optical assay test device in an exemplary optical assay method of use. The collection assembly  10  and method of use may be used in applications such as, but not by way of limitation, drug screening, chemical analysis, crime/accident scene investigations, ground water testing (EPA), and livestock testing. In alternative embodiments, the collection assembly  10  is used in other fluid transfer and/or fluid collection applications. 
         [0018]    The distal end  104  of the sample tube  100  may be put in communication with a fluid sample source. The fluid sample may be any fluid medium such as, but not by way of limitation, a gas, a liquid, a suspension, an extracted or dissolved sample, or a supercritical fluid, as long as some flow properties exist in the sample. The sample may include one or more target analytes of interest for detection. Example analytes include, but not by way of limitation, antigens, antibodies, receptors, ligands, chelates, proteins, enzymes, nucleic acids, DNA, RNA, pesticides, herbicides, inorganic or organic compounds or any material for which a specific binding reagent may be found. 
         [0019]    The bulb  30  is depressed by squeezing the opposite flexible, domed elastic members  35  inwardly, towards each other. As the opposite flexible, domed elastic members  35  are pressed inwardly, the glass vial  40  deforms and, then, breaks, causing fluid therein to be released/flow out of the vial  40 . 
         [0020]    Release of the bulb  30  creates a vacuum force in the bulb  30 , causing the sample to flow from the fluid sample source, through the tube  100  and the inlet check valve  70 , into the fluid path  69  in the interior  64  of the bulb  30 , where the sample mixes and reacts with the reagent released from the vial  40 . 
         [0021]    The bulb  30  is depressed again, causing the resulting reaction fluid to flow via the fluid path  69  out of the interior  64  of the bulb  30  and broken vial  40 , through the outlet check valve  80  and the one or more fluid paths  120 , and to the one or more test media  110 . The visual indicia of the one or more test media  110  may indicate the presence, absence, or concentration of a target analyte for the optical assay method. In an embodiment of the invention, multiple test media  110  are used to test for the presence, absence, or concentration of a target analyte of interest. 
         [0022]    Numerous features, implementations, and embodiments of the collection assembly  10  will now be described. The collection assembly  10  may be used more than once to perform the same test, different tests, or may be disposed of after single use. Different collection assemblies  10  may be used to perform different tests. The collection assembly  10  may be used to test for the presence, absence, or concentration of one or more analytes. The collection assembly  10  may be held and operated with a single hand of a user. The user may operate the depressable members  35  of the bulb pump  30  with a thumb and second digit of the same hand used to hold the collection assembly  10 . In an alternative embodiment, the collection assembly  10  may have only one depressable member  35 . The collection assembly  10  is especially advantageous in that the multiple transfer and mixing steps can all be done with a single hand of the user. 
         [0023]    Although the embodiment of the collection assembly  10  shown includes a single glass vial  40  with one or more chemical reagents or diluents, in an alternative embodiment, the collection assembly  10  may have multiple breakable viles or vessels  40 . The viles  40  may contain the same or different reagent(s)/diluent(s). Further, the collection assembly  10  may have one or more viles  40  containing one or more reagent(s)/diluent(s) and/or one or more separate reagent(s)/diluent(s) may be used with collection assembly  10  during the test process. 
         [0024]    In one or more embodiments of the collection assembly  10 , the sample tube  100  may have one or more of the following: the sample tube  100  may be fixed to the inlet  72 , the sample tube  100  may be retractable, the sample tube  100  may not be retractable, the sample tube  100  may lock to the inlet  72 , the sample tube  100  may not lock  72  to the inlet  72 , the sample tube  100  may detachably connectable to the inlet  72 , the sample tube  100  may include or be replaced with one or more wicks, sponges, open-cell foams, porous materials, or other absorbent materials. 
         [0025]    In a further embodiment, the collection assembly  10  may include one or both of the inlet check valve  70  and the outlet check valve  80 . Further, one or both of the inlet check valve  70  and the outlet check valve  80  may be replaced with one or more different types of valves. Still further, the collection assembly  10  may have a number of valves other than that shown, the number of valves depending on the number of bulb pumps  30 . 
         [0026]    The assembly  10  is advantageous in that it can be gripped in one hand and by the simple action of pressing and releasing the depressable members  35  of the bulb pump  30  with two digits of the same hand, fluid can be drawn into the fluid path  69  of the interior  64  of the bulb pump  30  through the inlet check valve  70 . Pressing and releasing the bulb pump  30  can cause the vial  40  to break (so the fluid therein is released) and the fluids to mix in the interior  64  of the bulb pump  30 . Pressing the bulb pump  30  again pumps the fluid out of the bulb pump  30  through the outlet check valve  80 . In an exemplary embodiment of the assembly  10 , the fluid pumped out of the bulb pump  30  can be collected on one or more test media to test the fluid for the presence, absence, or concentration of a target object in the fluid. Because the unit is so simple to use, the assembly  10  may be used by the user for testing in the field, in the lab, and in the home for a wide variety of applications. 
         [0027]    The above figures may depict exemplary configurations for the invention, which is done to aid in understanding the features and functionality that can be included in the invention. The invention is not restricted to the illustrated architectures or configurations, but can be implemented using a variety of alternative architectures and configurations. Additionally, although the invention is described above in terms of various exemplary embodiments and implementations, it should be understood that the various features and functionality described in one or more of the individual embodiments with which they are described, but instead can be applied, alone or in some combination, to one or more of the other embodiments of the invention, whether or not such embodiments are described and whether or not such features are presented as being a part of a described embodiment. Thus the breadth and scope of the present invention, especially in the following claims, should not be limited by any of the above-described exemplary embodiments. 
         [0028]    Terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term “including” should be read as mean “including, without limitation” or the like; the term “example” is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; and adjectives such as “conventional,” “traditional,” “standard,” “known” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Likewise, a group of items linked with the conjunction “and” should not be read as requiring that each and every one of those items be present in the grouping, but rather should be read as “and/or” unless expressly stated otherwise. Similarly, a group of items linked with the conjunction “or” should not be read as requiring mutual exclusivity among that group, but rather should also be read as “and/or” unless expressly stated otherwise. Furthermore, although item, elements or components of the disclosure may be described or claimed in the singular, the plural is contemplated to be within the scope thereof unless limitation to the singular is explicitly stated. The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent.