Patent Document

CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]    The present application is a continuation-in-part of, and claims the benefit under all relevant U.S. statutes, including 35 U.S.C. §120, to U.S. application Ser. No. 10/002,313 filed Oct. 24, 2001, titled APPARATUS FOR SAMPLING AND TESTING A SPECIMEN, in the name of Kenneth Alley. The present application also claims the benefits under 35 U.S.C. § 19(e) of U.S. Provisional Application No. 60/465,885 filed Apr. 28, 2003, titled ALLEY-AUTO SEALING APPARATUS FOR USE WITH DIAGNOSTIC TESTING CASSETTES in the name of Kenneth A. Alley.  
         [0002]    U.S. application Ser. No. 10/002,313 filed Oct. 24, 2001, and U.S. Provisional Application No. 60/465,885 filed Apr. 28, 2003, are hereby incorporated by reference as if fully set forth herein. 
     
    
     
       FIELD OF THE INVENTION  
         [0003]    The present invention relates generally to specimen collection and testing devices and, more specifically, to a self-contained, tamper-proof specimen testing system.  
         BRIEF DESCRIPTION OF THE PRIOR ART  
         [0004]    More companies are requiring new employees to undergo pre-employment drug testing before hiring. Also, post-accident drug testing is almost routine, especially when flammable or hazardous waste hauling is involved, or where the safety of a large number of people are concerned (e.g., oil tanker captain, truck driver or high-speed train engineer). Normally, a urine specimen is taken and tested by a local lab. If the test turns up positive, the specimen must then be sent to a more sophisticated, usually remotely located, testing lab.  
           [0005]    Companies that manufacture drug testing systems have developed specimen collection containers designed to be used with test cassettes. The test cassettes have reagent test strips attached thereto that change color in the presence of certain chemicals. The test cassettes must be submerged into the specimen collection container holding the liquid specimen. If the test results are positive, the cassettes are then removed and a lid is placed over the container prior to sending the remaining specimen to another lab for confirmation. Some companies incorporate a slot on top of the lid to slide the test cassette through, and if the test is positive, the entire lid must be replaced with a leak-proof lid.  
         SUMMARY OF THE INVENTION  
         [0006]    The present invention is a specialized container system that communicates with both typical testing cassettes and specialized split sample test cassettes also part of this invention. The system includes means to automatically seal the specimen container after the removal of the testing cassette. Unlike the AlleyBioSystems, totally self-contained, tamper-proof screening, testing and storage apparatus, the present invention is adapted to incorporate typical card style cassettes commonly used for diagnostic testing purposes. The auto sealing system may also be adapted to include the AlleyBio Isolator system, thus, splitting the sample and if desired, the untested portion of the sample may be preserved for future testing. The present invention may also be adapted to work with several geometric shapes including the round cassette that AlleyBio developed for its specialized toxicity cup technology. The present invention consists of a typical specimen container, a test cassette with means to communicate with the apparatus, a specialized closure that attaches to the specimen container, and a unique plug that communicates with both, the closure and the testing cassette.  
           [0007]    In order to ensure that there has been no tampering with the specimen and to prevent contamination of the specimen, AlleyBioSystems has developed a self-contained screening device. The self-contained screening device comprises a specimen container having a screw-top closure and a cassette with a single test strip or a plurality of reagent test strips that is encapsulated within the closure. The closure communicates with the cassette thus, providing means to activate the test when desired.  
           [0008]    The present invention does not require opening the specimen container during testing or prior to sending the sample out for confirmation, thus preventing to potential for cross contamination and or exposure to a bio-hazardous specimen. It also, improves the validity of the results by controlling access to the specimen.  
           [0009]    The present invention relates generally to specimen collection and testing devices, more specifically the specimen collection system includes a unique closure system that communicates with typical testing cassettes and with specialized testing cassettes claimed in this application. The specimen collection system provides means to safely access the specimen with a testing cassette and upon removal of the cassette the system is automatically sealed. The split specimen cassette separates the bulk specimen from the tested specimen. This system minimizes the potential for cross contamination and improves the chain of custody related to Drug of Abuse devices.  
           [0010]    After a patient has provided a specimen, the container can be sealed with the specially designed closure to prevent tampering and to prevent the accidental spilling of the specimen. When the cassette is engaged on to the closure, the test may be conducted without having to remove the closure. Additionally, after the test is preformed the cassette may be removed, thus simultaneously the container is automatically resealed and if necessary the entire container may be sent to a remote laboratory for confirmation testing.  
           [0011]    The present invention also consists of a specialized cassette designed to communicate with the closure and plug system. The specialized cassette consists of the described locking means to communicate with the plug and closure and additionally the cassette is adapted to a separate housing/cover that incorporates a wick. When the cassette is submerged into a specimen cup the wick is the only portion that contacts the sample specimen, thus splitting the specimen. The test strips never come into physical contact with the bulk specimen. (All other existing cassettes that are designed to dip into a specimen container actually submerge the bottom of the test strip into the bulk specimen, potentially contaminating the remaining specimen. In order to assure that the specimen is completely unadulterated the specimen would need to be split prior to dipping a test strip into the bulk specimen). The present invention provides a cassette that does not allow the test strips to contact the bulk specimen. The cassette consists of a strip holder and a housing that incorporates a wick. When the wick is submerged the cassette&#39;s test strips are isolated within the housing, thus physically separated. When the cassette is removed, the plug seal of the closure seals the container and then the cassette test strips move (slide) relative to the wetted wick, thus activating the test strips.  
           [0012]    (Note: The Wick is in the cover in the drawings, although it may be desired to place the wick on the cassette slide and the test strips on the housing cover, thus when the 2 separate components slide together the wick makes contact with the test strips. This particular configuration would be desired, if there was and over cap (or a pull tab at the top of the cassette to activate the test) to push to two components together to activate the test verses the plug system in the closure that pulls onto the cassette slide).  
           [0013]    The cassette or the wick may move relative to one another in order for the two components to make physical contact. The cassette has its own isolator system built into its design. As noted, such a cassette may also be adapted to communicate with an over-cap instead of a cup system. An over cap system may be more desirable for saliva or blood specimens where a buffer or reagent may be introduced when placing the cap over the specimen pad. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0014]    The foregoing summary, as well as the following detailed description may be better understood when read in conjunction with the accompanying drawings, which are incorporated in and form a part of the specification. The drawings serve to explain the principles of the invention and illustrate embodiments of the present invention that are preferred at the time the application was filed. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.  
         [0015]    In the drawings:  
         [0016]    [0016]FIG. 1 is a stacked side view of the ALLEY-auto sealing, tamper-proof screening, testing and storage apparatus.  
         [0017]    [0017]FIG. 2 is a top perspective view of the unique closure of the ALLEY-auto sealing, tamper-proof screening, testing and storage apparatus shown in FIG. 1.  
         [0018]    [0018]FIG. 3 is a side perspective view of the unique plug/seal of the ALLEY-auto sealing, tamper-proof screening, testing and storage apparatus shown in FIG. 1.  
         [0019]    [0019]FIG. 4A is a side perspective view of another embodiment of the ALLEY-auto sealing, tamper-proof screening, testing and storage apparatus with the Alley Isolator system adapted to the round cassette style of the Alley Toxicity Cup.  
         [0020]    [0020]FIG. 4B is a side perspective view of the round style cassette used in the Alley Toxicity Cup. The unique cassette may incorporate a test strip that is flexed (oriented) and operates in multiple planes. This cassette may be adapted to the closure described in FIG. 4A, of the ALLEY-auto sealing, tamper-proof screening, testing and storage apparatus with or without the Alley Isolator system adapted.  
         [0021]    [0021]FIG. 5 is a perspective view of the specimen isolator cassette designed to split the tested specimen from the bulk specimen. It includes Cover A. and Cassette-Slide B. Cassette B is placed into Cover A during assembly. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0022]    Referring now to FIG. 1, an apparatus for screening for the presence of drugs is shown. The apparatus consists of a test cassette  10  a lid  20 , a plug  30  and a specimen container  40 .  
         [0023]    The container  40  has a closed end and an open end. The lid  20  is designed to attach to the open end of the container  40  in order to close off the open end, thereby preventing the specimen stored in the container from escaping. In a preferred embodiment, the lid  20  is screwed onto the container  40 ; however, one skilled in the art could develop other means for attaching the lid to the container for example, snapping the lid over the container (for example, snapping the lid over the container&#39;s edges).  
         [0024]    In the present embodiment, the plug  30  snaps into the bottom of closure  20  prior to placing the closure onto the specimen container  40 .  
         [0025]    A patient deposits a specimen into container  40 . The container  40  is sealed with the specially designed lid  20  in order to store the specimen until a lab worker can test the specimen. The sealed container also prevents of the specimen.  
         [0026]    The lid  20  has a cassette slot  26  and receptacle  24  as shown in FIG. 2 to which the plug  30  is adapted. Referring now to FIG. 3, the plug  30  has sealing lips  35  that are designed to frictionally seal the cassette slot  26 . After the lid  20  is attached to container  40 , the specimen inside the container  40  is secured for transport and future testing.  
         [0027]    The plug  30  also has a gripping jaw  31  that extends partially into the slot  26  of the lid  20 . The jaw  31  is flexible and its purpose will be evident at least from the description that follows.  
         [0028]    When the specimen is to be tested, a specially designed cassette  10  may be utilized to access the specimen without opening the secured lid  20 . Referring again to FIG. 1, cassette  10  has rapid test strips attached thereto.  
         [0029]    In one embodiment illustrated herein, the test strips, are sandwiched between the thin, plastic that form the cassette  10 . Viewing windows  11  are placed on one side of the plastic sheets so that the provided test results may be read. Wicks  13  of the test cassette  10  are attached to the bottom ends of the test strips and will be submerged into the specimen, the wick  13  absorbs a small amount of the specimen and delivers the small amount to the test strips thus, activating the test strips.  
         [0030]    The cassette  10  is designed to slide through the slot  26  located on the top surface  22  of lid  20 . The cassette  10  has a leading edge receiving aperture  15 . The receiving aperture  15  is designed to communicate with the jaw  31  of plug  30 . When the cassette  10  engages the jaw  31 , the leading edge of the cassette  10  forces open the jaws  31  until teeth  33  snap into the cassette&#39;s receiving apertures  15 , thereby releasably locking the plug  30  to the cassette  10 .  
         [0031]    A downward force applied onto the cassette  10  will disengage plug  30  from the receptacle  24  of lid  20 . The cassette  10  slides through slot  26  until wicks  13  are submerged in the specimen, thus activating a rapid test strips.  
         [0032]    After the desired submersion time, the test cassette  10  may be pulled upward back through slot  26  of lid  20 . Since teeth  33  of the plug  30  are gripping the end of the cassette  10  through receiving aperture  15 , when the cassette  10  is removed from the specimen, the plug  30  is drawn upwards. Eventually the sealing lips  35  will engage the interior of receptacle  24  thereby aligning and once again securing the plug  30  to the cassette  10  by applying further force while withdrawing the cassette  10  the teeth  33  of plug  30  will open slightly thereby disengaging the receiving aperture  15  allowing the cassette to be completely withdrawn from the container  40 .  
         [0033]    It would be apparent to one skilled in the art, after reading the present disclosure, that modifications may be made to the basic invention. For example, FIGS. 4A and 4B illustrate the present invention modified to be used with a cylindrical cassette  70 .  
         [0034]    In this embodiment, apparatus  50  has a lid  55  adapted to a specimen container  57 , a plug  58  that seals the lid  55 , and a cassette  70 . (This embodiment may be adapted to be used with any cylindrically-shaped cassette, but is particularly adapted to be used with the specimen testing apparatus described in U.S. application Ser. No. 10/002,313 filed Oct. 24, 2001.) The container  57  stores the specimen. In one embodiment, the container has threads on its outer surface proximate its open end that matingly engage the lid  55 . A cup-shaped insert  56  is located inside the container  57  at its bottom.  
         [0035]    The cassette  70  has a circular top portion  77  and an elongated tube  78  that is designed to be inserted into the container through a cylindrical opening  52  in the lid  55 . The cassette  70  also has at least one test strip that lays flat against the circular top portion  77  and extends partially into the elongated tube  78 . The end of the test strip(s) that extend into the tube  78  may have appropriate wicks to assist in absorbing the speciment.  
         [0036]    The lid  55  has a cylindrical opening  52  adapted to communicate with both the round plug  58  and the elongated tube of cassette  70 . Circumferentially located about the cylindrical opening  52  is an isolator shaft  54  that extends away from the lid  55  and has an open end. The isolator shaft  54  has a clip means proximate its open end for engaging the cup-shaped insert  56  of the container  57 .  
         [0037]    After a specimen is deposited into container  57 , the lid  55  is screwed onto the container  57 . As the lid  55  seals over the open end of the container  57 , the isolator shaft  54  is immersed into the specimen and eventually snaps into the cup-shaped insert  56 , therby physically isolating a portion of the specimen from the rest of the specimen. The majority of the specimen is retained between the outer surface of the isolator shaft  54  and the inner surface of the container  57 . The portion of the specimen that is isolated within the isolator shaft  54  will eventually be used to “wet” the test strips within cassette  70 .  
         [0038]    Locking mechanism  72  shown in FIG. 4B performs a similar function as the aperture  15  of the previous embodiment. The cassette  70  enters through the cylindrical opening  52  of the lid  55 . The locking mechanism  72  of cassette  70  engages the fingers  59  of plug  58 , thereby allowing the plug  58  to move with the cassette  70  similar to the plug/cassette arrangement illustrated in the embodiment of FIG. 1.  
         [0039]    When the plug  58  latches on to cassette  70 , the further insertion of the cassette  70  will force the plug  58  to disengage from the end of the cylindrical opening  52  of lid  55  and the isolator shaft  54  will begin to be submerged into the isolated specimen within the isolator shaft  54 . Eventually the plug  58  will frictionally engage the cup-shaped insert  56  and seat itself within the cup-shaped insert  56 . When the isolator shaft  54  is sealed onto the isolator cup  56  there will be a portion of the specimen in both the inner isolator shaft  54  and a portion of specimen outside the isolator chamber. This isolator container provides the means necessary to split the sample. When the test cassette  70  is introduced to the apparatus  50  the test cassette will only contact the specimen within the inner isolator shaft  54 , thus leaving an unadulterated portion of the specimen between the isolator shaft  54  and the interior of the speciment container  57  for future testing.  
         [0040]    For example, if a positive result was obtained from the initial specimen, a second lab usually must confirm the results. At the second lab, the technician would remove the lid  55  from the specimen container. As the technician removes the lid  55 , the isolator shaft  54  is permanently attached to the cup-shaped insert  56 , thereby withdrawing the entire isolated portion of the specimen that was exposed to the original test strip(s). The remaining sample within the container  57  has never been exposed to any chemical reagents that may have been left by the first test strip(s). The remaining specimen would be unadulterated and may be used for future testing purposes.  
         [0041]    Referring now to FIG. 5, a perspective view of a specimen isolator cassette  100  designed to split a tested specimen from a bulk specimen is shown. This embodiment of the cassette  100  includes cover A and cassette-Slide B and is intended to take the place of the cassette  10  illustrated in FIG. 1. Cassette-slide B is designed to slide into Cover A during assembly. This specialized cassette  100  splits a portion of the specimen from the remaining bulk specimen and prevents the bulk specimen from interacting with the test strips.  
         [0042]    During assembly of cassette  100 , test strips are placed into grooves  101  of cassette-slide B. Cassette-slide B is then slid into cover A. (Cover A has its bottom end open thus allowing cassette-slide B to be slid into this opening.) As cassette-slide B is inserted into cover A, ears  110  are bent inwards and slide smoothly within cover A; however, detents  113  on cassette-slide B engage cutouts  111  in cover A, thereby preventing the cassette-slide B from moving any further relative to cover A.  
         [0043]    It is important to note that cassette-slide B also has ears  110  spaced a pre-determined distance away from detents  113 . The reason for including ears  110  and their positioning relative to detents  113  will become apparent after reading the entire disclosure. Finally, a pad wick  120  is placed in a depression on the inside of cover A; however, the pad wick  120  does not physically touch the test strips  13 .  
         [0044]    Proximate the leading edge of the cassette is a receiving aperture  15 B is designed to communicate with the jaw  31  of plug  30  in FIG. 1. When the cassette engages the jaw  31  they are forced around the leading edge of the cassette until jaw  31  snaps into the receiving apertures  15 B.  
         [0045]    A downward force applied to the cassette  100  will disengage plug  30  from the receptacle  24  of lid  20 . The jaw  31  of plug  30  is now attached to the receiving aperture  15 B of cassette  100 . Eventually, the absorbent pad wick  120  will be submerged into the specimen. (Note this does not activate the test as in prior art cassettes). The absorbent pad wick  120  of cassette  100  is isolated from the test strips in grooves  101 . After the absorbent pad wick  120  is wetted by the specimen within the container, the cassette  100  is removed from the bulk specimen container  40 . As the cassette  100  is withdrawn from the container  40 , the plug  30  again engages lid  20  and the sealing lips  35  close off the remainder of the specimen within the container  40 . Further pulling on cassette  100  will then force cover A to move relative to cassette-slide B forcing the detents  113  to disengage the cutouts  114  until ears  110  lock into cutouts  111  thereby permanently locking cassette-slide B to cover A at a new pre-determined position. As cover A moves relative to cassette-slide B, the wetted wick  120  then moves onto the lower ends of the testing strips, thereby activating the diagnostic test. Simultaneously, the jaws  31  disengage cutout  15 B thereby allowing the cassette  100  to be completely withdrawn from the container  40 .  
         [0046]    Referrring again to FIG. 5, cassette  100  may be adapted to communicate with an over-cap that holds a small specimen and has means to communicate with the receiving aperture  15 B of the cassette slide B. Cassette  100  may also be activated by physically pulling outward or by pushing inward (thus reversing the strip pad configuration) on the leading edge mechanism.  
         [0047]    The sample could be applied via dropper directly onto the absorbent wick  120 . With an over-cap, reagents could also be adapted through a liquid bypass.  
         [0048]    It should be noted that the cassette  100  could be adapted to work without the lid system of FIG. 1. Cassette-Slide B (tab) could extend up through cover A and, after the absorbent pad wick is wetted, the cassette may be removed from the bulk specimen and the tab can be pushed to activate the test, again never exposing the test strips to the bulk specimen.  
         [0049]    It would be apparant to one skilled in the art, after reading the present disclosure, to modify the invention described herein by, for example, placing the test strips within 100 cover A and placing the absorbent pad wick on cassette-slide B.  
         [0050]    In this particular embodiment, after the wick is wetted with a specimen, including saliva (or submerged into a cup) the cassette slide B, could be pulled upward, via tab or pushed (over-cap-with or without extra reagents) into the cover A, activating the test strips, again the bulk specimen never comes into contact with the test strips.  
         [0051]    Although this invention has been described and illustrated by reference to specific embodiments, it will be apparent to those skilled in the art that various changes and modifications may be made which clearly fall within the scope of this invention. The present invention is intended to be protected broadly within the spirit and scope of the appended claims.

Technology Category: 7