Abstract:
An apparatus for testing for the presence of a drug is provided. The apparatus includes a first drug testing reagent, a first ampule, a vessel that contains the first ampule, and a fracturing means. The first drug testing reagent contains a controlled substance detecting chemical reagent. The vessel serves as a mixing chamber for mixing the reagents with the test subject fluid. Further, the vessel may include a transparent wall through which changes in coloration of mixtures of test subject fluids and reagents may be viewed. The vessel may also comprise a test subject fluid injection port to allow for the injection of a test subject fluid into the vessel. The vessel may also contain means for fracturing the ampule without damaging or opening the vessel. A method for conducting a drug test is also provided.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
         [0001]    Not applicable.  
         STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
         [0002]    Not applicable.  
         BACKGROUND OF THE INVENTION  
         [0003]    This invention relates to drug testing. More particularly, this invention relates to color change indicia chemical reagent drug testing, and to apparatus and method steps for facilitating color change indicia chemical reagent drug testing.  
           [0004]    Conducting tests for the presence or absence of drugs is known. One method of testing for the presence of a drug is to mix a reagent with the substance to be tested, which indicates the presence of a drug by a color change. Commonly known chemical reagents for color change indicia testing for the presence or absence of controlled substance drugs include Meyer&#39;s reagent, Marquis reagent, Nitric acid reagents, Cobalt Thiocyanate reagent, Dille-Koppanyi reagent, Mandeline reagent, Mecke&#39;s modified reagent, and Diazepam/Valium reagent. Classes of controlled substance drugs which are detectable through reagent color indicia testing include barbiturates, amphetamines, opiates, and synthetic opiates.  
           [0005]    In order to test for the presence or absence of controlled substance drugs, a reagent, for example liquid nitric acid, is commonly held in an unsealed container. Thereafter, a test subject fluid, for example a fluid suspected of including the opiate Demerol, is introduced and mixed with the nitric acid fluid within the open-ended container. A change in coloration of the solution represents a positive result, indicating the presence of an opiate. The absence of any change in coloration indicates the absence of opiates within the test subject fluid.  
           [0006]    However, the performance of such chemical reagent drugs tests suffer from a number of drawbacks and deficiencies. For instance, the test described above typically requires one or more measuring steps and the manipulation of various vials, which can be time consuming and inconvenient. Moreover, the aforementioned technique may result in mis-measurements, inaccuracies, and spillage of liquids, which may compromise the reliability of the test results. Furthermore, the vials and vessels used to perform such drug tests commonly have no capacity for preserving the results of a test for future observation.  
           [0007]    Accordingly, there exists a need for a convenient apparatus and method for testing for the presence of a drug that substantially reduces mis-measurements, inaccuracies and the spillage of liquids while providing for the preservation of the test result. The present invention fills these needs as well as other needs.  
         BRIEF SUMMARY OF THE INVENTION  
         [0008]    In order to overcome the above stated problems and limitations there is provided a drug testing apparatus that is convenient, efficient and allows for the preservation of the test result.  
           [0009]    In general, the apparatus may include a first drug testing reagent, a first ampule, a vessel and a fracturing means. The first drug testing reagent comprises a controlled substance detecting or indicating chemical reagent such as, but not limited to, Meyer&#39;s reagent, Marquis reagent, Nitric acid reagents, Cobalt Thiocyanate reagent, Dille Koppanyi reagent, Mandeline reagent, Mecke&#39;s modified reagent, or Diazepam/Valium reagent. The first reagent may be hermetically sealed within the first ampule. The first ampule includes a frangible wall and is contained within the vessel. In particular, the first ampule may be formed of a tubular shaped thin glass wall having hermetically closed ends, such ends preferably comprising crimped heat fusion closures. Where a particular drug test requires multiple reagents, multiple frangible ampules containing different reagents may be provided within the vessel.  
           [0010]    The first ampule contains a drug testing reagents that is contained within the vessel. The vessel serves as a mixing chamber for mixing the reagents with the test subject fluid. The vessel may include a transparent wall through which changes in coloration of mixtures of test subject fluids and reagents may be viewed. The vessel also may comprise a test subject fluid injection port, such as, but not limited to, those common to hypodermic injection vials. The test subject injection port may include a pierceable elastomeric cannula receiving membrane that closes or covers the port so that the test subject fluid may no escape into an external environment. The vessel may also contain means for fracturing the ampules without damaging or re-opening the vessel.  
           [0011]    The ampule fracturing means may comprise an inwardly flexible wall of the vessel, such wall being inwardly flexible to the extent that an inner surface of such wall may impinge upon the one or more ampules contained within the vessel. The fracturing means fractures the ampule causing as release of the reagent within the vessel. Further, the ampule fracturing means may comprise a positioning of the test subject injection port to underlie or overlie an ampule within the vessel, allowing a cannula extending through such port to impinge upon and fracture the ampule. Furthermore, the ampule fracturing means may comprise a moveable member, for example, a steel ball, within the vessel, such moveable member being capable of percussively striking and fracturing the ampule.  
           [0012]    Additionally, the interior surface of the vessel may comprise ampule holding brackets for fixedly positioning the ampules within the second vessel. Further, an absorbent, such as, but not limited to, a fibrous pad may be contained within the vessel for absorbing mixtures of test subject fluids and reagents after testing and use. A splash guard wall may also be disposed within the vessel and between the absorbent and the ampules to prevent the absorbent from receiving and absorbing testing subject fluids or reagents prior to completion of a drug test.  
           [0013]    A method for conducting a drug test is also within the scope of the present invention. Assuming, for example, that an operator is in possession of a test subject fluid which is suspected of including an opiate, the operator selects a drug test vessel containing a nitric acid filled ampule. The test subject fluid is preferably contained within a hypodermic syringe. Such operator uses the cannula on the syringe to pierce the elastomeric membrane covering the chamber&#39;s test subject fluid injection port. The hypodermic syringe is then operated to inject the test subject fluid into the interior space of the vessel. Thereafter, the operator manually presses inwardly upon the vessel&#39;s flexible wall, causing the wall to impinge upon and fracture the nitric acid filled ampule contained therein causing the nitric acid to spill into the interior space of the vessel, and allowing mixing of the nitric acid and the test subject fluid. The operator may then view the interior space of the vessel through such vessel&#39;s transparent wall, observing any change in coloration of the mixture. In the event a coloration change is observed, a positive test result is noted, indicating the presence of an opiate within the test subject fluid. The vessel may then be tilted so that the lower surface of the vessel slopes downwardly toward the absorbent to allow the absorbent to receive and retain the mixed fluids.  
           [0014]    A procedure substantially identical to that described above may be performed where an operator is in possession of a controlled substance drug such as Demerol, where the operator has need of disposing of such drug, and where the operator has further need of confirming and verifying to others that such drug has been properly disposed of or wasted as opposed to having been misappropriated. In such circumstance, the present invention serves as a convenient chamber for controlled substance drug wastage, the above described method serving as a means for verifying that a drug wastage event has properly occurred to prevent drug misappropriation.  
           [0015]    Accordingly, the present invention provides a drug testing or drug wastage vessel or chamber which is capable of facilitating drug testing or of drug wastage verification through the performance of a single exterior fluid handling step, that step being fluid injection into the chamber where all other fluid handling steps, including fluid storage, occurs within the interior of such chamber. The present invention also provides a drug testing or drug wastage chamber including or containing a transparent wall, a fluid injection port, frangible reagent vials or ampules, and means for fracturing contained ampules without opening the chamber. Moreover, the present invention to provide a method for using the apparatus described above.  
           [0016]    Additional objects, advantages and novel features of the present invention will be set forth in part in the description which follows, and will in part become apparent to those in the practice of the invention, when considered with the attached figures. 
       
    
    
     BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS  
       [0017]    The accompanying drawings form a part of the this specification and is to be read in conjunction therewith, wherein like reference numerals are employed to indicate like parts in the various views, and wherein:  
         [0018]    [0018]FIG. 1 is a perspective view of the apparatus constructed in accordance with the present invention;  
         [0019]    [0019]FIG. 2 is a cross-sectional view taken along line  2 - 2  in FIG. 1;  
         [0020]    [0020]FIG. 3 is an exploded view of the apparatus shown in FIG. 1;  
         [0021]    [0021]FIG. 4 is a perspective view of the inner surface of a lid that forms a part of the apparatus shown in FIG. 1;  
         [0022]    [0022]FIG. 5 is an enlarged view of the area designated by reference numeral “ 5 ” in FIG. 2 showing the connection between the lid and bowl of the apparatus;  
         [0023]    [0023]FIG. 6 is a top view of the apparatus shown in FIG. 1;  
         [0024]    [0024]FIG. 7 is a top view similar to FIG. 6 showing completion of a test subject fluid injection step;  
         [0025]    [0025]FIG. 8 is a top view similar to FIG. 7 and sequentially shows completion of a first ampule fracturing step;  
         [0026]    [0026]FIG. 9 is a top view similar to FIG. 8 and sequentially shows completion of a second ampule fracturing step;  
         [0027]    [0027]FIG. 10 is a top view similar to FIG. 9 and sequentially shows completion of a step of inversion of the apparatus, allowing fluids to flow into an absorption chamber;  
         [0028]    [0028]FIG. 11 is a top view similar to FIG. 10 and sequentially shows completion of a step of absorption of fluids by an absorbent material within the absorption chamber; and  
         [0029]    [0029]FIG. 12 is a flow chart of a method for testing drugs according to the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0030]    Referring now to the drawings in detail, and initially to FIG. 1, reference numeral  10  generally designates the drug testing apparatus constructed in accordance with a first embodiment of the present invention. With additional reference to FIG. 7, apparatus  10  includes a hermetically sealed vessel  12  having reagents  14 ,  16  contained therein that are capable of indicating or verifying the presence of a drug when combined with a test subject fluid  18 . Test subject fluid  18  may be inserted into vessel  12  through an injection port  20 , which prevents any fluid contained within vessel  12  from being transferred to into an external environment. Apparatus  10  may also have an absorbent material  22  contained therein to absorb reagents  14 ,  16  and test subject fluid  18  after the test has been completed.  
         [0031]    As best seen in FIGS.  1 - 3 , vessel  12  may include a lower “clam shell” bowl  24  and an upper “clam shell” lid  26 . With additional reference to FIG. 5, the periphery of lid  26  may include a downwardly extending flange  28  having an inwardly extending lock ridge  30 . Further, bowl  24  may have a lower surface  32  with an upstanding wall  34  that extends upwardly from the periphery of lower surface  32 . The upper edge of upstanding wall  34  includes an outwardly extending lock ridge  36  that is selectively engagable with flange  28  and inwardly extending lock ridge  30 . Upon compressively fitting lid  26  over bowl  24 , ridges  30 ,  36  engage with each other so that lid  26  and bowl  24  are locked and sealed with one another. Specifically, the connection between lid  26  and bowl  24  hermetically seals the interior space defined by lid  26  and bowl  24  so that fluid contained within vessel  12  is unable to pass between lid  26  and bowl  24 . Preferably, interlocking ridges  30 ,  36  engage each other with a strength sufficient to prevent manual disassembly. Furthermore, vessel  12  is preferably a generally rectangularly shaped, but it will be understood that vessel  12  may also be shaped in accordance with numerous other common geometric shapes. In addition, it is also within the scope of the present invention to provide a vessel that is a one-piece structure.  
         [0032]    As best seen in FIG. 2, vessel  12  may include an ampule chamber  38  and an absorbing chamber  40 , each being defined by a splash guard wall  42 , upstanding wall  34  and lid  26 . In particular, the vertical height of splash guard wall  42  is less than the height of upstanding wall  34  of the vessel  12  so that test subject fluid  18  and reagents  14 ,  16  may flow from ampule chamber  38  into absorption chamber  40 .  
         [0033]    As best seen in FIGS.  1 - 3 , lower surface  32  of bowl  24  include a pair of brackets  44 ,  46  that may be fixedly attached to lower surface  32  or integrally formed therewith. Further, brackets  44 ,  46  are adapted to cradle frangible glass ampules  48 ,  50  and hold them in position. It will be understood and appreciated that ampules  48 ,  50  may be a vessel or another type of enclosed container. Further, ampules  48 ,  50  may be cradled within brackets  44 ,  46  so that they are positioned off of lower surface  32  of bowl  24  by approximately one-eighth inch. However, it is also within the scope of the present invention to position ampules at other distances from lower surface  32 . Further, a pair of end pieces  52  are positioned on opposite sides of ampules  48 ,  50  to prevent them from moving or sliding relative to each of their longitudinal axis. Frangible ampules  48 ,  50  necessarily contain drug testing reagents that may fill the entire ampule, or just a portion thereof depending on the drug being tested. Where a particular drug test to be performed by vessel  12  requires use of only one reagent, a single ampule may be used and positioned in either of ampule brackets  44 ,  46 . In addition, the present invention may also include the use of more than two reagents depending on the drug to be tested, which of course may also include the addition of additional ampules within vessel  12 . Moreover, it is also within the scope of the present invention to eliminate the use of ampules  48 ,  50  to allow one or more reagents to flow freely within vessel  12  prior to introducing test subject fluid  18 . If no ampules are used in conjunction with the reagents, then vessel  12  may be formed of a material that will not deteriorate under prolonged exposure to the reagents used in the present invention.  
         [0034]    As best seen in FIGS.  1 - 4 , lid  26  may have ampule fracturing lugs or protrusions  54 ,  56  fixedly attached, or integrally formed, to an inner surface  58  of lid  26 . In particular, protrusions  54 ,  56  may be positioned in such a way that they overlie or aligned with ampules  48 ,  50 . It will be understood and appreciated that the number of protrusions included in the present invention may correspond to the number of ampules contained within vessel  12 . It will of course understood that protrusions  54 ,  56  may be in any size or shape that will operate to break ampules  48 ,  50 . Further, lid  26  may be formed of a flexible plastic that allows lid  26  to be manually flexed from a normal position, depicted in FIG. 1, to an inwardly flexed position. When lid  26  is in a flexed position, protrusions  54 ,  56  impinge downwardly upon, and respectively fracture, ampules  48 ,  50 , allowing reagents contained therein to spill into interior spaces of vessel  12 . It will also be understood that other means may be utilized in place of, or in addition to, protrusions  54 ,  56  to break ampules  48 ,  50 . Further, ampules  48 ,  40  may also be fractured by a positioning of test subject injection port  20  to underlie or overlie ampules  48 ,  50  within vessel  12 , allowing cannula  60  extending through injection port  20  to impinge upon and fracture ampules  48 ,  50 . Furthermore, ampules  48 ,  50  may also be fractured by a moveable member, for example, a steel ball, within vessel  12 , such moveable member being capable of percussively striking and fracturing either or both of ampules  48 ,  50 .  
         [0035]    As best seen in FIGS. 1 and 7, lid  12  may also include test subject fluid injecting port  20  that is adapted to allow test subject fluid  18  into vessel  12 . As best seen in FIG. 3, injection port  20  is positioned within an aperture  62  formed in lid  26 , and may include a cannula receiving elastomeric membrane  64  that allows for the passage of fluid from an external environment to the inside of vessel  12 . In particular, as best seen in FIGS. 2 and 3, elastomeric membrane  64  is positioned within aperture  62  and is seated on an inwardly extending ridge  66 . As best seen in FIG. 7, it will be understood that a cannula  60  or similar device may be used to penetrate elastomeric membrane  64  and allow for the insertion of test subject fluid  18  into vessel  12 . Elastomeric membrane  64  prohibits test subject fluid  18  from moving back into the external environment from vessel  12  through injection port  20 .  
         [0036]    As best seen in FIGS. 1 and 2, a fibrous absorbent material  22 , such as a sponge, may be contained within absorption chamber  40  within vessel  12 . Thus, pad  22  may be partitioned from ampules  48 ,  50  by splash guarding wall  42  to prevent the absorbent from receiving and absorbing testing subject fluids or reagents prior to completion of a drug test.  
         [0037]    As best seen in FIG. 1, at least a portion of vessel  12  may be transparent or otherwise able to allow for viewing of any color changes of fluids contained therein. In particular, lid  26  may be formed of a transparent material. Further, both lid  26  and bowl  24  may be formed of a transparent material such as, but not limited to, plastic or other types of polymeric material. In the case where the entire vessel  12  is formed of a transparent material, a white adhesive label, not depicted, may be affixed to the outer surface of vessel  12  to provide a white background which aids in viewing of coloration changes in test subject fluid and reagents, and as media for writing or printing reagent used in the drug test, the drug believed to be inserted into vessel  12 , the resulting color of the reagent and drug mixture, the name of the individual witnessing the insertion of the test subject fluid into vessel  12 , and other information. However, it will be understood that vessel  12  may also be formed of an opaque material that may not allow for the viewing of the contents contained within vessel  12 . In this case, other means for determining the results of the drug test may be used with the present invention such as, but not limited to, spectrometry, electro-analysis, and other types of tests that convey the test results to the user.  
         [0038]    The types of drug testing reagents  14 ,  16  that may be used in the present invention include, but are not limited to, Meyer&#39;s reagent, Marquis reagent, Nitric acid reagents, Cobalt Thiocyanate reagent, Dille Koppanyi reagent, Mandeline reagent, Mecke&#39;s modified reagent, or Diazepam/Valium reagent. It will be understood that either liquid or dry reagents may be used with the present invention. The use of other types of drug testing regents are also within the scope of the present invention.  
         [0039]    In performing the method of the present invention, test subject fluid  18  is contained within a hypodermic syringe  68  having cannula  60  or other type of fluid transfer device that is capable of transferring test subject fluid through injection port  20 . The point of cannula  60  is placed on the surface of elastomeric membrane  64 , and cannula  60  is driven through membrane  64  to extend into the interior space of vessel  12 . As best seen in FIG. 12, the plunger of such hypodermic syringe is then operated to inject test subject fluid  18  through injection port  20 , into the interior space of vessel  12  in step  76 . When cannula  60  is withdrawn from injection port  20 , the elastic character of membrane  64  closes the injection aperture to reseal vessel  12  and prevent test subject fluid  18  from being transferred out of vessel  12 .  
         [0040]    Next, as best seen in FIG. 7, vessel  12  may be vertically oriented so that test subject fluid pool  18  flows to the lower corner of vessel  12 , which may be ampule chamber  38 . However, it is also within the scope of the present invention to orient vessel  12  in a generally horizontal plane or other orientation so that test subject fluid  18  is distributed on all, or a part of lower surface  32  of bowl  24 .  
         [0041]    As best seen in FIGS. 8 and 12, lid  26  is manually pressed inwardly so that protrusion  54  impinges upon frangible ampule  50  thereby fracturing frangible ampule  50  at step  78 . Fracturing ampule  50  causes reagent  16  contained therein to spill out into ampule chamber  38  allowing reagent  16  and test subject fluid  18  to form pool  70 . Due to the fracturing of ampule  50 , there may also be shards  72  included within pool  70  or located on lower surface  32 . The sealed connection between lid  26  and bowl  24  keeps pool  70  retained within vessel  12 . However, it will be understood that this step may not be necessary of ampule  50  is not used to contain reagent  16 .  
         [0042]    Thereafter, as best seen in FIGS. 9 and 12, and assuming that the drug test being performed requires two separate reagents included within separate ampules, lid  26  may once again be pressed inwardly causing protrusion  56  to fracture ampule  48  thereby causing it to spill reagent  14  into the interior of vessel  12  also represented by step  78 . Breaking ampule  48  results in the mixing of test subject fluid  18 , reagent  14  and reagent  16  thereby forming pool  74  at step  80 . Fluid pool  74  not only contains test subject fluid  18 , reagent  14 , reagent  16 , but also may conatin shards  72  from ampules  48 ,  50 . However, it will be understood that this particular step may not be necessary of ampule  48  is not used to contain reagent  14 . In any case, the operator, or some other user of vessel  12  observes the color of fluid pool  74  at step  82 , noting any positive or negative drug test results on the white adhesive label at step  84 . In addition, it will be understood that it is also within the scope of the present invention to break ampules  48 ,  50  at the same time.  
         [0043]    Thereafter, as best seen in FIG. 10, vessel  12  is inverted, allowing fluid pool  74  to flow between the inner surface of lid  26  and the upper edge of splash guard wall  42  and into absorption chamber  38 . As best seen in FIGS. 11 and 12, absorbent material  22  absorbs fluid pool  74  at step  86  in order to reduce the amount of fluids from flowing freely between ampule chamber  38  and absorption chamber  40 . Further, the weight of the absorbing pad may be predetermined so that the absorbent pad may be weighed after the drug test has been performed to check the amount of the drug wastage inserted into the injection port.  
         [0044]    The present invention for drug testing overcomes or ameliorates the drawbacks and deficiencies in the prior art. Specifically, a hermetically sealed drug test vessel or chamber having frangible reagent containing vials or ampules contained therein and having or incorporating an ampule fracturing means adapted for fracturing the ampules contained within the test chamber without opening the chamber allows for the preservation of the results of a drug test. In addition, a portion of the apparatus may be transparent to allow for viewing of the test results without having to break the seal on the apparatus. Further, the fact that the one or more reagents are contained in an ampule within the sealed vessel eliminates the inconvenience of measuring each of the reagents and possibility of spilling or mis-measuring the amount of reagent that must be used to conduct the drug test.  
         [0045]    While particular embodiments of the invention have been shown, it will be understood, of course, that the invention is not limited thereto, since modifications may be made by those skilled in the art, particularly in light of the foregoing teachings. Reasonable variation and modification are possible within the scope of the foregoing disclosure of the invention without departing from the spirit of the invention.