Abstract:
A screening device for testing bodily fluids for the presence of certain constituents. The device can include a planar front face through which all of the test strips are viewed. The device also includes an inclined surface that directs the fluid under test to test strips with more efficiency, and partitions the fluid that is directed to a given test strip to better assure that the test strip receives an adequate amount of bodily fluid for a valid analysis. In one embodiment, the device includes a three-dimensional gasket that creates a pressurized environment upon insertion of the sampling stem for improved diffusion of the bodily fluid into the test strips.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 14/079,558, filed Nov. 13, 2013, which claims the benefit of U.S. Provisional Patent Application No. 61/725,898, filed Nov. 13, 2012, the disclosures of which are incorporated by reference herein in their entireties. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This application is directed generally to devices and methods for analysis of the presence of constituents in fluids, and more specifically to devices and methods for analysis of the presence of constituents in bodily fluids for drug test screening. 
       BACKGROUND OF THE INVENTION 
       [0003]    Various drug screening devices are known for testing a sample of bodily fluids for the presence of certain constituents. These devices typically include a container for receiving a bodily fluid from a delivery device, and a plurality of reagent test strips arranged to contact the bodily fluid, with each test strip being sensitive to a particular constituent of interest. The targeted constituents for screening can range from controlled substances such as alcohol and marijuana to illegal substances such as cocaine and methamphetamines. 
         [0004]    For screening purposes, it is desirable to test for as many constituents as possible with a single sample, so as to reduce the nuisance factor associated with obtaining multiple bodily fluid samples. This is particularly a problem with saliva where sufficient quantities from multiple tests is problematic. Accordingly, many devices are intended to distribute the sampled bodily fluid among as many test strips as reasonably possible. This is typically accomplished by arranging a plurality of test strips on each of several sides of the container. 
         [0005]    Problems associated with a plurality of test strips arrayed on several sides of a test container include maldistribution of bodily fluid samples to the various test strips and the necessity to inspect more than one side of the container to determine the screening result. A screening device that addresses these maladies would be welcomed. 
       SUMMARY OF THE INVENTION 
       [0006]    Various embodiments of the invention include a device and method for adequately distributing a sample of bodily fluid among a plurality of test strips and preventing maldistribution of sampled fluid that can lead to an invalid test result, all while displaying the test results on a single face of the screening device. Certain embodiments also enable a slight and passive pressurization of a sampling chamber to augment the wicking or capillary action of the sampled fluid along the test strips. 
         [0007]    One problem with the prior art arrangement of having a plurality of test strips arrayed on several sides of a test container is that the arrangement is prone to operator error. Persons conducting the screening test often hold the screening device in their hand while awaiting the test results. While holding the device, there is a tendency to tilt the proximal face of the device backward for easier reading. Unfortunately, this can cause the bodily fluid under test to pool at the bottom of the distal face of the testing device, thus starving the test strips that are disposed on the proximal face. The result is an invalid test for the constituents represented by the test strips on the proximal face. 
         [0008]    Structurally, various embodiments of the invention include a container or cup having a first or “viewing” side through which all of the test strips can be viewed. The bottom of the cup is inclined and intersects the viewing side along a junction line that constitutes the lowest portion of the cavity within the cup where the bodily fluid collects. The test strips are oriented so that the detection end proximate the junction line for in contact with the bodily fluid that collects at the low portion of the cavity. By this arrangement, all of the test strips can be inspected by viewing a single surface of the cup, and the inclined surface of the bottom of the cup directs all of the bodily fluid into contact with the detection end of the test strips. Furthermore, the angle of the intersection between the bottom and the viewing side can be steep enough to counter a substantial holding angle induced by the operator. 
         [0009]    In certain embodiments, a three-dimensional gasket is implemented to provide certain sealing and pressurization advantages. The three-dimensional gasket can be made of a soft, pliable material to provide a sealing surface between the gasket and the cup and to provide a seal between a sampling stem that is inserted through the gasket. The pliable material can also cause the three-dimensional gasket to act as a diaphragm; when the sampling stem is inserted into the three-dimensional gasket, the displaced air causes the three-dimensional gasket to expand (as would a diaphragm), thereby causing the air contained by the three-dimensional gasket to become slightly pressurized. The pressurization can assist in the diffusion of the bodily fluid into the test strips, thus augmenting the capillary action between the bodily fluid and the test strip. 
         [0010]    The device can also provide barriers between the detection ends of adjacent test strips to prevent more absorbent or faster absorbing test strips from drawing test fluid away from less absorbent or slower absorbing test strips. 
         [0011]    A feature and advantage of embodiments of the invention is a specimen sampling device for saliva where the saliva is absorbed in a sponge, is squeezed into a saliva pathway of a specimen container, the saliva pathway is pressurized urging the saliva into engagement with a plurality of sample test strips. In embodiments a vent may be provided downstream of where the saliva engages the test strips. In embodiments, the plurality of test strips are each positioned in a plurality of recesses in a row, the recesses having an overfill level whereby fluid that overflows one recess flows into an adjacent recess. In embodiments, the pressurization may be provided by a stem attached to the sponge, the stem having a sliding plunger member. In embodiments the pressurization may be provided by a separate manual squeeze or push pump as part of the specimen sampling device. 
         [0012]    Another feature and advantage of embodiments of the invention is a specimen sampling device for saliva where the saliva is absorbed in a sponge, is squeezed into a saliva pathway of a specimen container, the saliva pathway leading to a plurality of sample test strips aligned in a linear row of at least 8 strips positioned on a substantially planar wall and exposed to be readable through one or more transparent regions, the strips having a sample receiving end that is placed at the bottom of an inclined plate in the saliva pathway. In some such embodiments, embodiments may have a gasket sealingly enclosing a specimen chamber including the inclined plate and a row of recesses into which the at least 8 strips extend. In some such embodiments, a curved, wall is positioned opposite the planar wall. 
         [0013]    An additional feature and advantage of embodiments of the invention is a specimen sampling device for saliva where the saliva is absorbed in a sponge, is squeezed into a saliva pathway of a specimen container, the saliva pathway leading to a plurality of sample test reservoirs, each with test strip extending therein, a gasket with a separate aperture for each respective test strip, the gasket providing sealing between the saliva pathway including and the reservoirs and regions of the container above the saliva pathway thereby preventing unintended migration of the saliva upward. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1  is an exploded view of a testing assembly for screening of bodily fluids in an embodiment of the invention; 
           [0015]      FIG. 2  is a perspective view of a cup of the testing assembly of  FIG. 1  in an embodiment of the invention; 
           [0016]      FIG. 3  is a sectional view of the cup of  FIG. 2 ; 
           [0017]      FIG. 4  is a perspective view of a test strip and sampling stem holder of  FIG. 1  in an embodiment of the invention; 
           [0018]      FIG. 5  is a side sectional view of the holder of  FIG. 4 ; 
           [0019]      FIG. 6  is a perspective view of the top of a three-dimensional gasket of  FIG. 1  in an embodiment of the invention; 
           [0020]      FIG. 7  is a perspective view of the bottom of the three-dimensional gasket of  FIG. 6 ; 
           [0021]      FIG. 8  is a perspective view of a test strip; 
           [0022]      FIG. 9  is a perspective view of a sampling stem of  FIG. 1  in an embodiment of the invention; 
           [0023]      FIG. 10  is a perspective cutaway view of the holder and three-dimensional gasket of  FIG. 1  in assembly; 
           [0024]      FIG. 11  is a sectional view of the cup, holder and three-dimensional gasket of  FIG. 1  in assembly; and 
           [0025]      FIG. 12  is a perspective cutaway view of the cup, holder and three-dimensional gasket of  FIG. 1  in assembly. 
       
    
    
     DETAILED DESCRIPTION 
       [0026]    Referring to  FIG. 1 , a testing assembly  20  for screening bodily fluids for the presence of certain constituents is depicted in an embodiment of the invention. The screening device includes a container or cup  22 , a test strip and sampling stem holder  24  (hereinafter “holder  24 ”), a three-dimensional gasket  26  and a sampling stem  28 . 
         [0027]    Referring to  FIGS. 2 and 3 , the cup  22  is depicted in isolation in an embodiment of the invention. The cup  22  includes a plurality of sides  32  and  34  that extend upward from a containment bottom  38  to form a continuous upper edge  36 , the sides  32 ,  34  and containment bottom  38  defining a cavity  42 . The sides  32  and  34  can also extend below the containment bottom  38  to establish a base portion  40  with a lower edge  41  registers the testing assembly  20  in an upright position. A first of the sides (side  32  in  FIGS. 2 and 3 ) can be substantially planar. In one embodiment, the containment bottom  38  defines an inclined surface  44  that intersects the plurality of sides  32  and  34 . The inclined surface  44  intersects the first side  32  along a junction line  46 , defining an acute angle θ between the first side  32  and the inclined surface  44 . The junction line  46  is the lowermost extremity of the cavity  42  when the cup  22  is in the upright position. 
         [0028]    While the inclined surface  44  is depicted as being substantially planar, it is noted that the inclined surface  44  is not limited to a planar configuration. For example, the inclined surface could also be convex, with a steeper slope at the junction line  46  than at other locations on the inclined surface. Alternatively, the inclined surface could be concave, with a more gradual slope at the junction line  46  than at other locations. 
         [0029]    In one embodiment, the containment bottom  38  can further include a pedestal portion  48  that extends from the inclined surface  44  into the cavity  42 . The pedestal portion  48  can include a top face  49  having a perimeter  50 . A securing structure  51 , such as a point or barb (as depicted in  FIG. 3 ), can be included on or as part of the top face  49  of the pedestal portion. 
         [0030]    Various embodiments of the cup  22  can also include a syringe access port  53  located proximate a lower corner of the cup  22 . The syringe access port comprises a region where the thickness of the cup  22  is thinned to enable manual puncturing with a syringe. 
         [0031]    The cup  22  can be fabricated from a variety of materials available to the artisan, including but not limited to polycarbonate, styrene-butadiene copolymers (SBCs) such as K-RESIN, and clear styrene. 
         [0032]    Referring to  FIGS. 4 and 5 , the holder  24  is depicted in isolation in an embodiment of the invention. The holder  24  includes a cap portion  52  having an access port  54  formed therein. The holder  24  also includes a through passage structure  56  that defines a through passage  58  that passes through the holder  24 . The through passage structure  56  includes a proximal end  60  and a distal end  62 , each being concentric about an insertion axis  64 . The proximal end  60  of the through passage structure  56  includes the access port  54 . The through passage structure  56  can comprise a hollow tube that depends from the cap portion  52  (as depicted), or a bore that extends through a substantially solid holder  24 . 
         [0033]    The holder  24  also includes a planar face  66  that extends downward from the cap portion  52 . The planar face  66  includes a plurality of parallel ribs  68  that define a plurality of elongate channels  72 . The elongate channels  72  each define a channel axis  74 . 
         [0034]    The holder  24  can be fabricated from a variety of materials available to the artisan, including but not limited to polycarbonate, styrene and acrylonitrile butadiene styrene (ABS). 
         [0035]    Referring to  FIGS. 6 and 7 , the three-dimensional gasket  26  is depicted in an embodiment of the invention. The three-dimensional gasket  26  includes a passage extension structure  82  that defines an extended passage  84  and a diaphragm portion  86  that depends from and extends radially outward from the passage extension structure  82 . A perimeter structure  88  of the three-dimensional gasket  26  surrounds and depends from the diaphragm portion  86 , the perimeter structure  88  having a lower face  92  that extends below the diaphragm portion  86 . The three-dimensional gasket can also include a notch  91  that, upon assembly, aligns with the syringe access port  53  of the cup, enabling easy access to the chamber  150 . The three-dimensional gasket  26  can also include guide tabs  93  that assist in guiding, registering and seating the three-dimensional gasket into the holder  24  during assembly. 
         [0036]    The perimeter structure  88  includes a front portion  90  having an outer face  94  and an inner face  96 . The outer face  94  is adapted to contact an inner surface of the first side  32  of the cup  22 . In one embodiment, the inner face  96  includes a plurality of riblets  102  that extend inwardly, in the general direction of the extended passage  84 . The riblets  102  can include lower surfaces  104  configured to engage the inclined surface  44  of the containment bottom  38 . In one embodiment, the three-dimensional gasket  26  is fabricated from a soft, pliable material such as polyvinylchloride (PVC) or neoprene. 
         [0037]    Referring to  FIG. 8 , a test strip  110  is depicted. The test strip  110  includes a detection end  112  and a non-detection end  113 . The detection end  112  wicks fluid to a sensing zone  114  via capillary action through an absorbent material  116 . The sensing zone  114  is configured with reagents that react and provide a visual indication when a certain constituent is present in the bodily fluid. A width  118  of the test strip  110  is dimensioned to slidingly engage a corresponding one of the elongate channels  72 . In the depicted embodiment, the test strip  110  is characterized as having increased thickness at both the detection and non-detection ends  112  and  113  due to the presence of the absorbent material  116 . 
         [0038]    Referring to  FIG. 9 , the sampling stem  28  is depicted in an embodiment of the invention. The sampling stem  28  is characterized as having a proximal portion  132  and a distal portion  134 . The proximal portion  132  can include a handle or knob  135  for handling and manipulation of the sampling stem  28 . Certain aspects of the sampling stem  28  are depicted and described at U.S. Patent Application Publication No. 2012/0094303 to Engel et al., which is hereby incorporated by reference herein except for express definitions contained therein. The sampling stem  28  can be fabricated from a variety of materials available to the artisan, including but not limited to polycarbonate, styrene-butadiene copolymers (SBCs) such as K-RESIN, and clear styrene. 
         [0039]    In one embodiment, the proximal portion  132  includes structure that is complementary with structure on the cap portion  52  for securing the sampling stem  28  in a fixed position along the insertion axis  64  relative to the cap portion  52 . In the depicted embodiment, the complementary structures comprise a female threaded structure  136  proximate the access port  54  of the cap portion  52  of the holder  24  and a male threaded portion  138  proximate the proximal portion  132  of the sampling stem  28 . Other complementary structures could also be utilized, including a detent-and-groove snap fit structure a bayonet-style lock or a clasp. 
         [0040]    In one embodiment, the sampling stem  28  and the access port  54  are configured to provide a ratchet-and-pawl mechanism for rotationally locking the sampling stem  28  relative to the holder  24 . In the depicted embodiment, the sampling stem  28  includes a pawl  142  distal to the male threaded portion  138 . The pawl  142  is configured to engage ratchet notches  144  ( FIG. 4 ). 
         [0041]    The distal portion  134  of the sampling stem  28  includes a sampling swab  140  that is mounted to a collar  141 . In one embodiment, the collar  141  is comprised of a transparent material to enable ultraviolet activation of bonding agents that are placed between the sampling swab  140  and the collar  141 . The distal portion  134  is configured for insertion through the through passage  58  and extended passage  84 . In one embodiment, the collar  141  is sized to provide a sliding seal between the collar  141  and the extended passage  84 . Also, in one embodiment, the through passage  58  as well as the extended passage  84  is tapered (i.e., has a larger diameter at the proximal end than at the distal end) in order to guide the distal portion  134  without causing it to bind, but still affecting a seal as the collar  141  approaches its final axial location along the insertion axis  64 . 
         [0042]    Referring to  FIGS. 10 through 12 , the testing assembly  20  is depicted in various states of assembly. In assembly, the three-dimensional gasket  26  is coupled to the bottom of the holder  24  and the test strips inserted into the respective elongate channels  72  so that the detection end extends into the extended channel. The holder  24  and three-dimensional gasket  26  assembly, with test strips  110  loaded in the channels  72 , is inserted into the cup  22  such that the three-dimensional gasket  26  is disposed between the holder  24  and the containment bottom  38 . The cap portion  52  of the holder  24  is brought into contact with and joined to the continuous upper edge  36  of the cup  22  ( FIG. 12 ). Any joining or bonding method available to the artisan can be utilized to join the cap portion  52  to the cup  22 , including gluing, fusion or sonic welding, or a detent-and-groove snap fit engagement. 
         [0043]    After assembly, the orientation of the elongate channels  72  of the holder  24  are such that the channel axes  74  are substantially perpendicular to the junction line  46 . The extended passage  84  is in substantial alignment with the through passage  58  and is substantially concentric about the insertion axis  64 . The pedestal portion  48  can extend partway into the extended passage  84 . The perimeter  50  of the top face  49  of the pedestal portion  48  can be normal to the insertion axis  64 , and can also be concentric about the insertion axis  64 . 
         [0044]    The three-dimensional gasket  26  can be compressed between the holder  24  and the inclined surface  44  of the containment bottom such that the lower face  92  of the perimeter structure  88  is in sealing contact with the inclined surface  44  of the containment bottom  38 . The outer face  94  of the front portion  90  of the perimeter structure  88  can also be in sealing contact with the interior of the first side  32  of the cup  22  just above the junction line  46 . In this way, a chamber  150  is defined, bounded by the diaphragm portion  86 , the perimeter structure  88  and the inclined surface  44 . The chamber  150  is accessible via the extended passage  84 . 
         [0045]    Each of the riblets  102  of the three-dimensional gasket  26  extend into the chamber  150  and are in substantial alignment with a corresponding one of the ribs  68  of the planar face  66  of the holder  24  to form a plurality of channel extensions  152 . Engagement of the lower surfaces  104  of the riblets  102  with the inclined surface  44  creates a plurality of pockets  154  (partially depicted in  FIG. 7 ) that are proximate the junction line  46 . In one embodiment, the detection end  112  of a given strip  110  accesses the channel extensions  152  and pockets  154  through slots  156  ( FIG. 6 ) formed proximate the front portion  90  of the perimeter structure  88  of the three-dimensional gasket  26 . The slots  156  can be dimensioned so that the absorbent material  116  of the detection end  112  of an occupying test strip  110  is in light contact with the interior of the slot  156 . During assembly, the light contact between the test strip  110  and the slot  156  can be enough to hold the test strip  110  in its respective elongate channel  72  until the assembly operation is complete. 
         [0046]    In operation, the sampling swab  140  of the sampling stem  28  is saturated with bodily fluid to be analyzed (e.g., saliva from a person being screened for drug use). The distal portion  134  of the sampling stem  28  is then inserted into the access port  54  and slid through the through passage  58  of the holder  24  and into the extended passage  84  of the three-dimensional gasket  26 . The sampling swab  140  is thereby brought into contact with the pedestal portion  48 . The sampling stem  28  is further pushed into the access port  54  until the male threaded portion  138  of the sampling stem  28  is engageable with the female threaded structure  136  of the access port  54  (or other complementary coupling structures become engageable). The male threaded portion  138  is then threaded into the female threaded structure  136  until the proximal portion  132  of the sampling stem  28  is fully engaged within the access port  54  (e.g., by registration of the knob  135  against an upper periphery of the access port  54 ). 
         [0047]    For embodiments utilizing the ratchet-and-pawl mechanism, the threading action (rotation of the sampling stem  130 ) causes the pawl  142  to engage with the ratchet notches  144 . This prevents the sampling stem  28  from rotating out of the access port  154 , thus locking the sampling stem  28  in a fixed axial position along the insertion axis  64 . 
         [0048]    The threading action between the proximal portion  132  and the access port  54  also causes the sampling swab  140  to be further extended into the extended passage  84  of the three-dimensional gasket  26 , causing the sampling swab  140  to be compressed against the pedestal portion  48  (when present) or, more generally, against the containment bottom  38 . The securing structure  51  secures the sampling swab  140 , thereby inhibiting the swab  140  from sliding laterally relative to the insertion axis  64 . By securing the sampling swab  140 , more efficient extraction of bodily fluid from the sampling swab  140  is attained during compression. 
         [0049]    The compression acts to wring the bodily fluid out of the sampling swab  140 , which then flows over the pedestal portion  48 , down the inclined surface  44  and along saliva pathways  160  ( FIG. 12 ) to pool along the inner face  96  of the perimeter structure  88  proximate the lower most portion of the cavity  42 , i.e., into the pockets  154  located proximate the junction line  46 ). The pockets  154  that are nearest the center of the three-dimensional gasket  26  (i.e., more proximate the insertion axis  64 ) will tend to receive more fluid initially than the pockets  154  located near the extreme corners of the three-dimensional gasket  26 . The riblets  102  can be dimensioned so that the pockets  154  accept only an amount needed to adequately activate the corresponding test strip  110 . Accordingly, as the bodily fluid flows into the nearest of the pockets  154 , these pockets will overflow and cascade over the riblets  102  as the pockets  154  become successively filled. Given an ample quantity of bodily fluid, all of the pockets  154  should receive sufficient bodily fluid for analysis. In one embodiment, the riblets  102  are sized and spaced so that a dozen pockets  154  can hold 1 ml of fluid and the sampling swab  140  sized to accept 20 ml of bodily fluid. 
         [0050]    The depicted embodiments present twelve elongate channels  72  for housing twelve test strips  110 ; however, configurations having more or less channels  72  can also be implemented, depending on the quantity of fluid available for analysis. Typically, the number of elongate channels  72  ranges from 6 to 15. 
         [0051]    While the cascading action between the pockets  154  can take several seconds, the absorption by the test strips  110  is on the order of minutes. Therefore, the riblets  102  prevent more absorbent or faster absorbing test strips from drawing test fluid away from less absorbent or slower absorbing test strips, thus providing better and more predictable analysis results. 
         [0052]    The insertion of the distal portion  134  of the sampling stem  28  into the extended passage  84  also acts to pressurize the chamber. The three dimensional gasket  26  can be made of a soft, pliable material, so that the perimeter structure  88  provides a seal with the inclined surface  44 , and a seal is also affected between the collar  141  and the extended passage  84  as the collar  141  of the sampling stem  28  reaches its final position within the extended passage  84 . Thus, as the distal portion  134  of the sampling stem  28  moves into its final position, air is displaced and pushed into the chamber  150 . The pliable material can also cause the diaphragm portion  86  to flex, thereby causing the air contained by the three-dimensional gasket  26  to become slightly pressurized. While some venting may occur between these sealed surfaces, as well as through the absorbent material  116  deposited in the slots  152 , the pressurization can still assist in the diffusion of the bodily fluid into the absorbent material  116 , thus augmenting the capillary action between the bodily fluid and the test strip  110 . 
         [0053]    All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, can be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. 
         [0054]    Each feature disclosed in this specification (including any accompanying claims, abstract and drawings) can be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features. 
         [0055]    For purposes of interpreting the claims for the present invention, it is expressly intended that the provisions of Section 112, sixth paragraph of 35 U.S.C. are not to be invoked unless the specific terms “means for” or “step for” are recited in the subject claim.