Abstract:
The present invention is directed to diagnostic kits that house and deliver a carrier for an analyte, such as a test strip carrying an blood glucose analyte used by persons afflicted with diabetes in order to determine their blood glucose levels.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention is directed to diagnostic kits that house and deliver a carrier for an analyte, such as a test strip carrying a blood glucose analyte used by persons afflicted with diabetes in conjunction with determining their blood glucose levels.  
         BACKGROUND OF THE INVENTION  
         [0002]    Numerous devices are known in the art for packaging and housing the test strips which contain any of a number of analytes used by persons in the medical arts, or persons who, due to a medical condition, must test for the presence, absence, or level of a substance in their body. For instance, persons with diabetes apply their blood to test strips, in order to determine their blood glucose levels.  
         SUMMARY OF THE INVENTION  
         [0003]    The present invention is directed to a meter strip dispenser assembly which includes a housing containing components that when actuated, will dispense a test strip. Further the assembly includes a vial which contains a cassette that houses test strips, and further, an assembly that delivers the test strips to a location where they are displaced from the container.  
           [0004]    The vial containing the cassette and test strips is situated within the housing. The housing is further provided with a button that is in engagement with a mechanism that moves a rod into contact with a test strip, and displaces it from the vial. In one embodiment, the test strip is movable from a first position within the vial to a second position partially outside the vial, and a third position in which it has been completely removed from the vial. In a further embodiment, the movement from the first to second to third position is dependent upon the actuation of the mechanism, which moves between positions to effect the aforenoted movements of the test strips.  
           [0005]    In a further embodiment, a cassette is housed within the vial. The cassette is provided with a mechanism that moves test strips into a position from which they can be dispensed from the vial.  
           [0006]    The vial used in the meter strip assembly is one that can be opened to permit access to the test strips housed within it. However, when the assembly is not in use, it may be desirable to seal the strips of from the environment to prevent strip degradation, something which could be brought about by humidity, among other things. Accordingly, the vial may be made resealable, such as by providing the vial with a cap or a lid that can be sealed onto the container body (or removed therefrom, as the case may be) as often as necessary. In yet a further embodiment, the vial is provided with a lip seal, in which the displacement of test strips can be pushes them through the seal and out of the container. In this arrangement, the vial remains in substantially sealed except in those brief moments when a strip is moved through the seal. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0007]    [0007]FIG. 1 is an exploded view of an embodiment of the assembly of the present invention.  
         [0008]    [0008]FIG. 2 is an exploded view of a further embodiment of the present invention.  
         [0009]    [0009]FIG. 3 is a perspective view of an aspect of an embodiment of the present invention.  
         [0010]    [0010]FIG. 3A is an elevational view of an embodiment of the present invention.  
         [0011]    [0011]FIG. 4 is a side elevational view showing the movement of the pegs through the guide track.  
         [0012]    [0012]FIG. 5 is an exploded view of the vial, cassette, and lift mechanism of a further embodiment of the present invention.  
         [0013]    [0013]FIG. 6 is an exploded view of the assembly of the present invention showing the vial, cassette, and lift mechanism of FIG. 5.  
         [0014]    [0014]FIG. 6A is an exploded view of an embodiment of the assembly of the present invention  
         [0015]    [0015]FIG. 7 is a side elevational view of a vial in a further embodiment of the present invention.  
         [0016]    [0016]FIG. 7A is another view of the vial of FIG. 7.  
         [0017]    [0017]FIG. 7B is an alternative to the vial of FIGS. 7 and 7A.  
         [0018]    [0018]FIG. 8 shows a further embodiment of the present invention 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0019]    Meter Strip Dispenser  
         [0020]    The meter strip dispenser  10 , shown in an exploded view in FIG. 1, is constructed of a housing  12  constructed of two halves  14 , a button  16 , an actuator  18 , and a spring  20 . Each of two halves are provided with opposing sides  22  and skirts  24  which extend perpendicular to the opposing sides  22 . The skirts  24  are each provided at their edges with a profile complimentary to the profile of the other skirt, which permits the joinder of the halves, forming the predominant portion of the housing. The two halves can be joined together by screws, such as an arrangement in which a screw passes from one half and is received by apertures provided in the other half.  
         [0021]    Each of the halves are provided with openings in their skirt regions  24 , one opening  26  being provided on the top side  28 , and the other opening  30  being provided on one of the long sides  32 . When the halves are joined, the openings  26 ,  30  form an aperture in the top side  26  and an the aperture  30  in the long side  32 . The vial containing the test strips resides in the top opening  26 , while button  16  resides in the side opening  30 .  
         [0022]    Recesses  34 A, defined by partitions  34 , are provided on the inside of each half  14 . The partitions  34  extend inwardly from the sidewalls, into the interior of the housing  12 . The recesses receive pegs  36  that are provided on the actuator  18 . When the halves  14  of the housing  12  are joined together, the pegs  36  reside within the recesses. The partitions  34  that define the recesses guide the actuator  18  along a path which results in the movement of a test strip out of the housing. Further, situating the pegs within the recesses stabilizes the actuator mechanism so that it is not able to engage in significant side-to-side movement within the housing. The actuator is, however, able to move along the path, as will be explained later.  
         [0023]    Additional recesses  38  are provided up in the inside of each half  14 . These recesses receive pegs  40  provided on the button  16 . When the button is pressed, the button pivots inwardly around the pegs.  
         [0024]    The inward facing side  42  of button  16  is provided with a recess  44  in which elbow  46  of the actuator  18  is snugly fitted, forming an interference fit. Elbow  46  is provided with knob  48  having aperture  50  which receives hook  52  of coil spring  54 . A second hook  52  is provided at the other end of the spring, which is positioned around peg  56 . The spring biases the button positioned to the inwards position.  
         [0025]    Actuator  18  is provided with lower portion  56  which includes leg portion  57  which ramps upward to elbow  46 . Lower portion  56  ends with fork  58 , to which studs  36  are attached. Upper portion  60  of the actuator  18  includes leg  61  that ramps up and away from elbow  46  to bend  62 . Vertical portion  63  extends from the bend  63  to pusher bar  64  which extends horizontally from upper position  63 .  
         [0026]    Pushing on the button  16  of the assembled housing moves the actuator, with the pusher bar moving in a substantially horizontal plane. The pusher bar is positioned within the slot  66  formed by the horizontally extending members located on the inside of the halves  14 . Pusher bar  64  is slidably mounted within slot  66 . Slot  66  guides the motion of the pusher bar  64 .  
         [0027]    All materials used in the making of the housing and associated components (with the exception of the spring, which preferably is a metal material) can be formed of plastic materials, according to well known extrusion, blow molding, or injection molding techniques.  
         [0028]    In an alternative embodiment, shown in FIG. 2, the actuator  18  and pusher bar  64  are shown as discrete components, as opposed to a unitary construction as in the previous embodiment. Here, the actuator  18  is comprised of a distinct lower component  56 , and upper component  60 , and pusher bar  64 . The lower component  56  is attached to the housing  10  by pegs  36  that are received in recesses within the housing. At one end, lower component  56  is joined to button at location  44  where peg is inserted into the aperture  51  on the end of the lower component  56 . Lower component  56  is further provided with an aperture  50  that receives an end of spring  20 . The spring  20  has another end  21  which is fixed to a peg or the like on the housing  12 . The spring is biased to keep the button in an inward position.  
         [0029]    The upper component  60  is joined to the pusher bar  64  by peg  36 . Upper component  60  is joined to the button at location  44  where peg  36  is inserted into the aperture  51  on the end of the upper component  60 . The pusher bar  64  resides within the slot  66 . The pusher bar is positioned within the slot  66  formed by the horizontally extending members located on the inside of the halves  14 . Pusher bar  64  is slidably mounted within slot  66 . Slot  66  guides the motion of the pusher bar  64 .  
         [0030]    Vial and Cassette  
         [0031]    Turning now to FIG. 3, the test strips are housed within a cassette  70  located within a vial  72 . The cassette is a box-shaped apparatus that resides within the vial. The cassette is dimensioned and structured to receive a stack of test strips, dispense them one at a time, until the cassette has been emptied. The cassette is provided with length dimension L and width dimension W which accommodate the corresponding dimensions of the strip while maintaining the strips in an orderly stack. The cassette is further provided with a height dimension H that permits the cassette to hold a plurality of test strips. Merely for exemplary purposes, the height dimension H may be selected to allow for 50 test strips. However, the height dimension H may be varied to allow for a greater or lesser number of strips.  
         [0032]    The cassette is closed on its top surface  72  and open on the bottom surface 74  (i.e., no bottom wall material is present at  74 ). The test strips are loaded into the cassette from the bottom  74 . Apertures  76  are located near the top surface  72  of the cassette on the small sides  78  of the cassette. The apertures are large enough to permit the pusher bar  64  to move in and out of one of the slots, and to permit an individual test strip to be moved out of the other opening on the cassette.  
         [0033]    At least one of the large sides  80  of the cassette is provided with a slot that runs in the height direction H. The slot runs from the bottom  74  of the cassette to the top  72  of the cassette, to at least the level of the opening  78 .  
         [0034]    The Vial and Cassette Construction  
         [0035]    Vial  81  is of a conventional design having a cap  82 , container  83 , sidewall  84 , and container bottom  85 . The cap  82  is attached to the container by a hinge  86 . Suitable vial constructions have been described in U.S. Pat. Nos. 5,911,937, 6,080,350, 6,124,006, and 6,130,263, as well as pending application nos. 09/156,937, and 09/156,720. In another embodiment, a plug or other similar insert may be inserted into the container that is constructed of a desiccant plastic, or at least a portion of the interior of the container may be constructed of a desiccant plastic. The desiccant plastic is described in U.S. Pat. Nos. 5,911,937, 6,080,350, 6,124,006, and 6,130,263, as well as pending application nos. 09/156,937, and 09/156,720 all of which are incorporated by reference herein.  
         [0036]    The cassette  80  is loaded with strips, placed inside the vial, with lift apparatus  88  positioned under the test strips. The lift apparatus has a post  90  which is threaded through the coils of a helical spring  92 . One end  93  of the spring  92  rests within the vial at the bottom thereof. At the top end  94  of the pole  92  a lift  96  is threaded over the pole  92 . The lift  96  is provided with pole  92  engaging portion  97  in which apertures  98  are present in a solid surface  99 . Pole engaging portion of lift is connected to the lift surface  100  by mid portion  101 . The lift surface  101  is sized and shaped to fit within the cassette, and to move in the height dimension of the cassette without being unduly interfered with by the inside walls of the cassette.  
         [0037]    In operation, the test strips are loaded into the cassette. The lift surface  100  is placed inside the cassette, so that the test strips rest on the lift surface  100 . The midportion  101  is positioned within the slot  82  on the cassette. The biasing action of the spring, which presses against the floor of the vial container and the underside of the pole engaging portion  97 , keeps the pole engaging portion elevated, so that the top most test strip of the stack is in position to be removed from the cassette.  
         [0038]    The vial and cassette, as loaded in the housing, is shown in FIG. 3A. To dispense a test strip, the user pushes the button  16  on the housing  10 . This moves the actuator so that the pusher bar  64  enters through an opening  78  in the cassette, pushing the top strip of the stack partially out of the cassette and exposing it so the user can use it for testing, such as by wetting the strip with a bodily fluid, such as blood. After the strip has been wetted, a second push of the button, the pusher bar moves the test strip completely out of the canister. The upward biasing action of the spring on the lift move the lift upward when this tet strip is dispensed, which moves the next highest test strip into the dispensing position.  
         [0039]    Pushing button  16  inward activates components  60 ,  61  and  64 . The pegs associated with these components which sit in the guide tracks keep the components in the tracks. In response to activation, the components move through the tracks and the pusher bar enters the vial.  
         [0040]    [0040]FIG. 4 is a side elevational view which tracks the movement of a lower peg  36  through recess  36 , which serves as a guide track. The peg starts at position A. When the button is pressed, the levers are activated. The peg tracks to position B, and continue on to position C, where it comes to rest. At position C, the pusher bar has pushed the test strip partially out of the opening in the cassette. When the button is activated a second time, the peg travels to position D, and then continues back to position A, where it comes to rest. At this position, the test strip has been pushed completely out of the cassette.  
         [0041]    In a further embodiment, shown in FIGS. 5 and 6, the lift apparatus has a different arrangement. The vial  84  is provided with an aperture (not shown) on its bottom surface, through which an activating rod  110  is inserted into the interior of the vial  84  . The activating rod  110  is threaded, and receives the threaded aperture provided on the lift  96 .  
         [0042]    The bottom side of the vial is provided with downwardly extending sidewalls  112  which house a gear  114  having a threaded aperture  116  that receives the bottom threaded portion  118  of the activating rod  110  . Spacer  120  is provided on the activating rod and rests on the gear.  
         [0043]    To accommodate this lift apparatus construction, the meter strip dispenser of FIG. 1 is modified to include a second recess  44   a  into which the butt end  124  of gear actuating member  126  is received. This arrangement is shown in FIG. 6A. Gear actuating member  126  has a base portion  128 , on one side of which the butt end  124  extends. Two parallel rails  130  extend out from the opposite side of the base portion  128 . Teeth  132  are provided on the inside walls  134  of the parallel rails  130 . The teeth  132  may be angled out from the inside walls  134  and provided with a flat edgel 36  facing away from the base portion  128 .  
         [0044]    When the button is pushed, the gear actuating member  126  moves forward, which causes the teeth  132  to engage the gear  120 , and the activator rod  110  to rotate. However, the lift  96 , which is threaded on to the activator rod  110  , is constrained against rotation by the tight space in which it is located, i.e., the tight space immediately adjacent the vial sidewalls and the cassette. Accordingly, the activator rod  110  rotates through the lift, causing the lift to rise. Since the activation of the button turns the gear in an incremental movement, the lift rises in an increment, which corresponds to the thickness of a test strip. The test strip is dispensed in a manner consistent with the manner described with respect to the FIG. 1 embodiment.  
         [0045]    Another suitable embodiment for a vial construction is shown in FIG. 7. In this embodiment, the vial is provided with a lip seal  119 , through which the test strips pass when they are dispensed from the vial. At least a portion of the interior of the vial maybe lined with a desiccant plastic  121 , which is discontinued in the region of the lip seal, providing a location for an opening through which the test strips are dispensed. See FIG. 7A. The lip seal  119  is located at the junction between the top side wall  120 A and bottom side wall  120 B. The outer container side walls  184  can be formed by blending a sufficient amount of elastomer with the carrier thermoplastic material. The flexibility of this material allows for the formation of the lip seal. That is, the lip seal exhibits a desirable degree of flexibility that permits the test strip to exit through the seal when subjected to the action of the pusher element. The desiccant plastic  121  may optionally be provided with tip  122  positioned so that the top test strip of the stack slides over it when it is dispensed from the container. FIG. 7B shows the absence of the tip.  
         [0046]    The lip seal  119  can be modified in a yet a further embodiment in which a mating profile is provided in the thickness dimension of the elastomer has a mating profile that. That is, as shown in FIG. 7, the top side wall  120 A is provided with an member  121  which extends beyond edge  125  of top side wall  120 A. Member  121  mates with groove  123  provided in edge  126  of the bottom side wall  120 B. This arrangement helps guide the lip seal components back together after a test strip has been dispensed through the lip seal.  
         [0047]    In yet a further embodiment, the lift assembly may constructed of a coiling spring, such as a TENSATOR® spring. This spring tends to coil, so that as the spring coils from an initial elongated position, the stack of test strips placed on top is moved upward as the diameter of the coil increases incrementally. The spring is fixed at a first movable end within the vial. In response to the dispensing of the test strips, the spring moves downward in the cassette, causing the spring to coil, moving the stack upward.  
         [0048]    [0048]FIG. 8 illustrates an embodiment of a vial construction in which the spring can be employed. The vial  81  is provided with the aforenoted components: the container  183 , the cap  182 , and the hinge  186 . A number of ribs  188  extend from the container sidewalls  184  into the container interior, defining an open space  190  into which the test strips can be snugly fitted. (In this embodiment, housing the test strips in a cassette is optional.) The interior of the vial is further provided with an upper wall region  192  that define a basin  194  having a sink  195  and a notch  196 . The upper portion of the spring  200  has a head  198  and neck portion  199  attached to the body  201  of the spring  200 , which are respectively fitted in the sink  195  and the notch  196 . The lift apparatus  202  is an element having a flat upper surface  204  upon which the test strips rest. Sidewalls  206  extend downward from the flat upper surface  204  on the long  205  and short sides  207  of the apparatus. On the long side  205  of the lift apparatus  202 , the middle M of the apparatus is open. In other words, the downwardly extending long side  205  is discontinued in the middle M of the apparatus  202 , providing a location where the coil  210  of the spring  200  can pass under the apparatus. With this arrangement, the apparatus rests on the coil  210 , which increases in diameter as the stack of test strips is depleted.  
         [0049]    When the head  198  and neck  199  of the spring  200  are placed within sink  195  and notch  196 , the spring  200  is coiled, the coil  210  being near the top of the open space  190  in which the cassette or test strips is to be placed. When the test strips are placed on the coil  210 , the spring  200  uncoils partially. The lid  182  of the vial  81 is shut. Preferably, the vial  81  is provided with a lip seal  119  such as that described in conjunction with FIG. 7. Test strips are dispensed from the vial by the movement of mechanisms previously described, with pusher bar  64  entering the vial from one end and pushing a test strip out through the other end. The underside of the vial lid is provided with guide tracks  220  that guide the pusher bar  64  along the path it takes when moving through the vial.  
         [0050]    Numerous modifications and variations of the present invention are possible in light of the above teachings. It is evident that variations on the present invention may be constructed, which, in accordance with controlling law, are still subject to the claims written in view of the preceding disclosure.