Abstract:
The present invention is a collection assembly useful for collecting small quantities of blood. The assembly comprises a container with an integral lip for facilitating collection of the blood, a cap suitable for enclosing the container and a flow inducing means. The assembly further comprises a sealing arrangement for securing the cap with the container and a cam arrangement for unsecuring the cap from the container.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    1. Field of the Invention  
           [0002]    This invention relates to a collection assembly and more particularly to a microcollection container and cap suitable for collecting small quantities of blood from a patient and maintaining the blood in secure fashion for subsequent testing.  
           [0003]    This invention is an improvement over the collection assembly described and claimed in U.S. Pat. No. 5,384,096, issued Jan. 24, 1995, which is hereby incorporated by reference.  
           [0004]    2. Description of Related Art  
           [0005]    Analytical instrumentation has made it possible to carry out a variety of hematological diagnostic procedures on very small quantities of blood. Because of this, a patient&#39;s finger or earlobe, for example, may be punctured and a very small quantity of blood may be rapidly collected into a container for such testing. However, in order to carry out testing and analysis on small quantities of blood, the blood must be rapidly collected prior to any coagulation thereof.  
           [0006]    A collection arrangement as described in U.S. Pat. Nos. 4,397,318 and 4,690,153 have been provided wherein a cap is configured to fit the top of a microcollection container with the cap having a removable capillary scoop for engaging the puncture site and transferring blood to the container. However, with such an arrangement, if precise positioning is not carried out, capillary action is not initiated or slowed and the collected blood will clot.  
           [0007]    Moreover, when a sample is taken with this collection arrangement, blood droplets may be left in and around the top area of the container. When the scoop is removed from the cap and the cap is fitted onto the top of the container, the excess blood may be forced onto the outside surface of the container.  
         SUMMARY OF THE INVENTION  
         [0008]    The present invention is a collection assembly comprising a container and a cap. The cap preferably comprises a top portion, a bottom portion, and an annular skirt extending from the top portion to the bottom portion having an inner surface and an outer surface. The cap further includes an inner inverted skirt portion surrounded by the inner surface of the annular skirt. Most preferably the inner inverted skirt portion is separated from the inner surface of the annular skirt by an annular space. Most preferably, the cap also includes a cam follower positioned on the bottom portion. Desirably, the inside surface of the annular skirt comprises at least one protrusion and the inner inverted skirt portion has a sealing ring. The cap further comprises a rim extending from the outer surface of the annular skirt.  
           [0009]    The container preferably comprises an open top portion, a closed bottom portion, a sidewall extending from the top portion to the bottom portion and an open end associated with the top portion having an integral collector. Most preferably the integral collector is a scoop that is the same diameter as the inner diameter of the container so that no air vent is required.  
           [0010]    Most preferably, the container further includes a flow inducing member which serves as a guide for inducing blood flow passage along a surface. Such flow inducing members include, for example, an elongated rod or strip arrangement incorporated into the container in such a way that the collected blood is guided from the integral collector continuously into the container. Therefore, capillary action causing blood “hang-up” does not take place and blood flows rapidly through the integral collector into the container. This is turn reduces blood sample waste in the small total quantities involved, resulting in a larger specimen yield.  
           [0011]    Most preferably, the flow inducing member is a strip that may be positioned along the integral collector and the inner wall of the container. Thus, the invention induces sequentially, rapid flow into the container, as well as rapid flow along the inner tube wall to the bottom thereof.  
           [0012]    Preferably, the flow inducing member is a single film strip made of polyethylene, polypropylene, polystyrene, polycarbonate, tetrafluoroethylene or glass.  
           [0013]    Desirably, the flow inducing member may be rigid or flexible, a thin film or a rigid strip.  
           [0014]    Preferably the elongated flow inducing member of the present invention may be in the form of integral or separate rods, strips or indentations so as to provide a continuous flow inducing or guiding surface for the sample being collected from the initial sample site to the bottom of the container and they may be separately formed, and either merely positioned or adhered to the inner wall of the container or may be incorporated into the mold of the container.  
           [0015]    Preferably, the container further includes a cap seating flange associated with the outer diameter of the top portion of the container and an extending annular skirt associated with the bottom portion. Most preferably, a reservoir is positioned within the cap seating flange and at least one lug is located in the reservoir. Preferably, the container also includes a locking ring associated between the integral collector and the cap seating flange.  
           [0016]    Preferably, the collection assembly includes means for securing the inner surfaces of the cap to the top portion of the container by the interaction of the protrusions of the cap with the locking ring of the container and the sealing ring of the cap with the inside surface of the top portion of the container. Most preferably, the collection assembly also includes means for unsecuring the cap from the container by a cam arrangement on the cap and container. This cam arrangement assists in substantially reducing fluid splatter from the container when the cap is removed from the container.  
           [0017]    In a preferred embodiment of the invention, the cam arrangement includes at least one cam follower positioned on the bottom portion of the cap and at least one cam surface positioned in the cap seating flange of the container. A downwardly rotational force applied to the cap and an upwardly force applied to the container along the longitudinal axis, causes the cam follower and the cam surface to align and the cap to snap-seal to the container by the interaction of the protrusions of the cap with the locking ring of the container and the sealing ring of the cap with the inside surface of the top portion of the container. This action, which may cause an audible-snap, in turn seals the container by compressing the protrusions of the cap against the locking ring of the container and the sealing ring of the cap against the inside surface of the top portion of the container to form a non-permanent lock and to substantially prevent the outer surface of the top portion of the container from making contacting with the inside surface of the cap&#39;s annular skirt.  
           [0018]    The cap and container are then unsecured in a twist off manner by applying a rotational force to the cap. Most preferably, an upward rotational force is applied to the cap and a downwardly force applied to the container along the longitudinal axis. This causes the cam follower to rise on the cam surface and in turn the cap is unsecured from the container. An important advantage of the present invention is that the rotational force applied to the cap can be bidirectional, that is clockwise or counter-clockwise.  
           [0019]    The collection assembly of the present invention is preferably used in microcentrifuges. However, an extension may be secured and unsecured to the bottom portion of the container. The extension increases the length dimension of the container. With the extension, the container may be compatible with standard clinical centrifuges.  
           [0020]    An advantage of the present invention is that any excess fluid on the outside surface of the integral collector is directed downwardly into the cap seating flange by the inner surface of the annular skirt of the cap when a downward force is applied to the cap as the cap and container are being secured. Therefore, radial spray of excess fluids are minimized.  
           [0021]    Another advantage of the invention is that the cap may be secured and unsecured to the bottom portion of the container. In particular, the annular space in the cap between the annular skirt and inverted skirt allows the cap to be removably secured with the bottom portion of the container by receiving the annular skirt of the container.  
           [0022]    Still another advantage of the invention is that the recessed inverted skirt and the sealing-ring substantially reduces cap contact with fluid collected in the container. Therefore the inner surfaces of the cap may be minimally exposed to fluid collected in the container when the cap is secured to the top portion of the container.  
           [0023]    Another advantage of the present invention is that the outer surface of the cap may preferably be configured to substantially limit movement or rolling of the cap or the assembly. This applies whether the cap is positioned with the top portion or bottom portion of the container.  
           [0024]    Still another advantage of the present invention is that when the cap is secured to the container, the rim of the cap substantially prevents contamination to the specimen inside the container.  
           [0025]    Most notably, the present invention enhances the movement of blood from the collection site and into the container. The present invention substantially minimizes blood “hang-up” so that blood flows rapidly through the internal collector and into the tube.  
           [0026]    The present invention assists the user in collecting small quantities of blood that can be transferred rapidly into a collection container. The present invention substantially minimizes the clotting of blood because of the rapid collection. 
       
    
    
     DESCRIPTION OF THE DRAWINGS  
       [0027]    [0027]FIG. 1 is a perspective view of a collection assembly illustrating the container with the cap unsecured.  
         [0028]    [0028]FIG. 2 is a side elevational view of the container of FIG. 1, partially in section of the cam surface area.  
         [0029]    [0029]FIG. 3 is an enlarged cross sectional view of the cap of FIG. 1, taken along line  3 - 3  thereof.  
         [0030]    [0030]FIG. 4 is a bottom view of the cap of FIG. 1.  
         [0031]    [0031]FIG. 5 is a side elevational view, partially in section, of the collection assembly of FIG. 1 with the cap secured to the top portion of the container.  
         [0032]    [0032]FIG. 6 is a side elevational view, partially in section, of the collection assembly of FIG. 1 with the cap removably secured to the bottom portion of the container.  
         [0033]    [0033]FIG. 7 is a perspective view of the preferred collection assembly of FIG. 1 and an optional extension that may be removably secured to the collection assembly.  
         [0034]    [0034]FIG. 8 is a side elevational view, partially in section, of the collection assembly of FIG. 7 with an extension removably secured to the bottom portion of the container.  
         [0035]    [0035]FIG. 9 is a perspective view of an alternate embodiment of the present invention illustrating a collection assembly with a container, a cap and a flow inducing means.  
         [0036]    [0036]FIG. 10 is a top end view of the collection assembly of FIG. 9 without the cap.  
         [0037]    [0037]FIG. 11 is a longitudinal cross-sectional view of the collection assembly of FIG. 9 without the cap. 
     
    
     DETAILED DESCRIPTION  
       [0038]    Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof, FIG. 1 illustrates a collection assembly  10  comprising a container  12  and a cap  14 .  
         [0039]    As illustrated in FIG. 1, container  12  has a sidewall  22  having an outer surface  24  and an inner surface  26 . The sidewall extends from an upper portion  28  to a lower portion  30 . Upper portion  28  includes an open end  31  and an inner surface  27  with a top surface  32  having an integral lip portion  34  with a receiving edge  36 . Lower portion  30  comprises a closed bottom end  38  and an annular skirt  37  extending from the closed bottom end and outer surface  24  to define a compartment area  39 . Annular skirt  37  provides a means for allowing the container to be placed upright on a flat surface.  
         [0040]    Upper portion  28  has a cap seating flange  40  positioned around the outer surface of the container which defines a well or trough  42  and an outer surface  41 . The cap seating flange has an upper surface edge  43  and a plurality of lugs  44  each having a cam surface  46 . Although a container having only one project lug is within the purview of the instant invention, a plurality of lugs is preferred. Also, although other shapes and configurations are within the purview of the instant invention, lugs  44  of this embodiment are triangularly shaped.  
         [0041]    As shown in FIG. 2, further positioned on the outer surface of the container on the upper portion is a locking ring  48  positioned between receiving edge  36  of integral lip portion  34  and cap seating flange  40 . The locking ring has an upper edge  50  and a lower edge  52 .  
         [0042]    Cap  14  as shown in FIG. 3, has a top surface  54 , a bottom stop ledge  56  and an annular outer skirt  58  extending from the top surface to the bottom stop ledge. The annular outer skirt has an outer wall surface  60  and an inner wall surface  62 . A shield  66  extends from the outer wall surface of the annular outer skirt and has an outer surface or circumference  76 .  
         [0043]    As shown in FIG. 3, cap  14  also has an inner annular inverted recessed skirt portion  64  that extends from top portion  54  to a bottom surface  63 . The inverted recessed skirt portion defines a compartment or cup area  65  on the top portion of the cap. The inner wall surface of the annular outer skirt and the inner annular inverted recessed skirt are spaced from each other to define an annular space  68 . The cap further includes, a plurality of circumferentially spaced protrusions  70  positioned on inner wall surface  62  and a sealing ring  67  positioned on inverted recessed skirt portion  64 . Projecting lugs  72  are located on bottom stop ledge  56  wherein each lug comprises a cam follower surface  74 . Although a cap having only one projecting lug is within the purview of the instant invention, a plurality of lugs is preferred. Also, although other shapes and configurations are within the purview of the instant invention, lugs  72  of this embodiment are triangularly shaped.  
         [0044]    As shown in FIG. 4, flats  77  are positioned on the outer surface of shield  66 . The flats substantially prevent the cap from rolling and provide a convenient grasping surface for ready removal and placement of the cap on the container. Although a shield with a smooth outer circumference without flats is within the purview of the instant invention, a shield with an outer surface with flats is preferred.  
         [0045]    As shown in FIG. 5, when cap  14  is removably secured to container  12 , space  68  of the cap receives the top portion of the container including the integral lip, protrusions  70  bear against lower edge  52  of locking ring  48  of the container, sealing ring  67  bears against inner surface  27  of the container and cam follower  74  contacts cam surface  46 . Shield  66  covers outer surface  44  of cap seating flange  40  and bottom stop ledge  56  abuts with upper surface edge  43  of the cap seating flange  40 , so as to form a non-permanent lock and substantially prevent any excess fluid in well  42  of the cap seating flange from spilling out. Any fluid that migrates between upper surface edge  43  and bottom stop ledge  56  is directed in a downward direction along the container. Further, any fluid in well  42  is substantially contained by the upper surface edge of the cap seating flange and the bottom stop ledge of the cap.  
         [0046]    Cam follower surface  74  and cam surface  46  are configured so that a downwardly rotational force applied to cap  14  about longitudinal axis  80  causes cam follower  74  to contact cam surface  46 . Cap  14  is snapped onto the top portion of the container as guided by cam follower surface  74  and cam surface  46 . Cap  14  is removably secured to container  12  by protrusions  70  and sealing ring  67  as they bear respectfully against lower edge  52  of the locking ring and inner surface  27  of the container. The position of the protrusions and sealing ring of the cap with the container forms space  69  between the outer surface of the top portion of the container and the inner wall surface of the cap&#39;s annular outer skirt. Therefore, wiping down of any fluid on the container&#39;s outer surface is substantially prevented.  
         [0047]    The cap is unsecured from the container in a twist-off manner by applying a rotational force about longitudinal axis  80  while holding the container. Rotation of the cap with respect to the container causes cam follower surface  74  to rise on cam surface  46  and in turn the cap is unsecured from the container. The rotational force applied to the cap can be bi-directional, that is clockwise or counter-clockwise.  
         [0048]    As shown in FIG. 6, cap  14  is readily compatible with skirt  37  on the lower portion of the container. Space  68  of the cap receives the skirt of the container. When the cap is positioned on the bottom of the container during fluid collection, the cap provides a means for allowing the container to be placed upright on a flat surface.  
         [0049]    As shown in FIGS. 7 and 8, extension  90  is optionally available to be inserted into skirt  37  on the lower portion of container  12 . The extension may be optionally used to make the collection assembly compatible with standard centrifuges or the need for additional space for labeling. Multiple extensions may be used if needed.  
         [0050]    The invention as shown in FIGS.  9 - 11  include many components which are substantially identical to the components of FIGS.  1 - 4 . Accordingly, similar components performing similar functions will be numbered identically to those components of FIGS.  1 - 4 , expect that a suffix “a” will be used to identify the similar components of FIGS.  9 - 11 .  
         [0051]    As illustrated in FIG. 9, an alternate embodiment of the invention is assembly  100  which includes a flow inducing means as shown in FIG. 9, in the form of a film strip  120 , one end of which is partially adhered to the inner surface of integral lip portion  34   a  and along inner surface  26   a  of sidewall  22   a . While strip  120  is adhered to the various surfaces of the container, it is within the purview of this invention that the flow inducing member may be positioned without adherence in desired locations in the collection assembly.  
         [0052]    Strip  120  serves to provide a transition or bridge across the inner surface of the integral lip portion onto the inner surface  26   a  of the container. Thus, when blood is collected by receiving edge  36   a  of integral lip portion  34   a , it comes in contact with strip  120  which serves to induce and lead the blood sample rapidly through the integral lip portion and into the container and thereon to lower portion  30   a  of the container.  
         [0053]    Preferably, strip  120  may be adhered to the inner surface of the integral lip portion and the inner wall of the container with heat or it may be adhered by an adhesive material.  
         [0054]    Preferably, strip  120  may be a flat, curved, concave, convex, bent into a “V” or “N” shape, square, round or triangular.  
         [0055]    In addition, a slight hollow may be formed between strip  120  and the inner surface of the integral lip portion to enhance capillary action.  
         [0056]    In addition, strip  120  may have a coating such as an anticoagulant or silicone. In addition, strip  120  may be treated by plasma or corona methods.  
         [0057]    The collection assembly of the invention may be made of a clear molded thermoplastic material so that the specimen collected may be readily viewed. Representative materials include, for example, polyethylene, polypropylene and polyvinyl chloride. The collection container may incorporate a hydrophilic material or a silicon may be applied to the internal surface thereof for enhancing the flow of blood introduced into the container.  
         [0058]    Although it is within the purview of the invention to provide caps which are colored to define specific forms of fluid collection containers containing materials for one reason or another or for defining the kind of examination to be conducted on the specimen collected, transparent caps may be provided. Also, it should be noted that the dimensions of the container are such as to provide space for labeling which may be important for identifying the collected specimens.  
         [0059]    Although it is within the purview of the invention to provide a flow inducing means which is color coded to define the location of the flow inducing means, the flow inducing means may be provided as the same color or transparent as the container.