Abstract:
A liquid specimen collection container is described that includes a cup which has a base, an edge portion, and a sidewall extending from the base to the edge portion. The container additionally includes a lid disposed on the edge portion. The lid has a recessed portion which forms a protrusion extending downward into the cup. The container also includes a flexible extraction tube permanently affixed to the bottom of the protrusion with the tube reaching the base of the cup. The container further typically includes a transfer means positioned inside the recessed portion of the lid, the transfer means in liquid communication with the flexible tube. The transfer means assists in transferring liquid from the container to another vessel. A system is also described that includes the above specimen collection container and a vessel into which collected liquid is transferred from the container.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to a specimen collection container for collecting biological fluids, particularly urine specimens. 
       BACKGROUND OF THE INVENTION 
       [0002]    Laboratory analysis is often required of biological fluids. This is particularly true of urine. Collecting and analyzing urine is problematic because collection is typically done in open top cups. After collection of the urine, the cup is closed with a tight fitting lid attached by threads or snapped on employing flange-like elements. However, for analysis purposes, smaller portions of the liquid than the amount generally collected are required; these smaller portions are typically removed from the cup into 5-10 cc evacuated test tubes. 
         [0003]    Removal of these smaller portions is typically effected by assemblies that include an evacuated test tube and a needle cannula. One end of the needle cannula is positioned to be in liquid communication with the urine in the cup, while the second end of the needle cannula is configured to be pushed through a vacuum seal into an evacuated test tube. The resultant pressure differential generates a flow of the bodily fluid through the needle cannula into the test tube. 
         [0004]    Evacuated test tubes may be used for collecting urine when the amount of urine collected is sufficient for the needle cannula to extend into the cup and reach the liquid. However, when only small amounts of urine are collected from a patient, the level of the liquid may not reach the cannula. In such cases, medical personnel often must tilt the specimen cup so that the maximum amount of liquid can reach the cannula while an amount of liquid remains in the cup. Even more problematically, medical personnel may try to exert additional pressure. They may try to push the test tube and needle cannula deeper into the cup. In some cases, this approach may be successful as the lid through which the cannula extends is usually formed of relatively thin plastic. However, often this approach is unsuccessful and may even be dangerous. 
         [0005]    Pushing sharp and fragile objects, particularly when possibly biologically hazardous materials are involved, is not a good strategy. It would therefore be advantageous to develop a specimen collection container which allows for drawing off samples of sufficient size when the total amount of liquid collected is smaller than the amount for the required one or two test tubes. 
         [0006]    When an insufficient amount of urine is obtained from a patient, the nurse or doctor will ordinarily request the patient to go to the facilities and try to produce more urine. Often, the patient is unsuccessful. He repeats this procedure several times walking back to the facilities without producing the desired result. He may then sit opposite the nurse disturbing her in various ways, such as by asking her questions. He will make visits to the cafeteria after which he will return again to disturb the nurse and in general be disruptive. The nurse therefore wants a simple quick method and device to reduce the frequency of occurrence of such situations. Therefore, it again would be advantageous for the develop of a specimen collection container which allows for drawing off samples of sufficient size when the total amount of liquid collected is small. 
         [0007]    A typical prior art liquid specimen collection container is described in U.S. Pat. No. 6,921,395 to Carano et al. The system described therein indicates many of the elements appearing in currently constructed specimen collection containers. 
       SUMMARY OF THE PRESENT INVENTION 
       [0008]    It is an object of the present invention to provide a specimen collection container for transferring the maximum amount of collected biological fluid where the total amount of collected fluid may be small. Typically, but without intending to be limiting, the fluid is urine. 
         [0009]    It is a further object of the present invention to provide a specimen collection container having a flexible extraction tube reaching the bottom surface of the container. Such a container does not require tilting or additional pressure to remove a portion of the collected liquid for laboratory analysis. 
         [0010]    It is yet a further object of the present invention to provide a system for collecting a biological fluid and extracting a portion of the collected fluid for use in laboratory analysis. 
         [0011]    There is thus provided in accordance with one aspect of the present invention a liquid specimen collection container. The container includes a cup and a lid. The cup has a base, a sidewall extending substantially transversely from the base, terminating in an edge portion, such that the base and the sidewall form a cavity. The lid is formed for leak-resistant seating on the edge portion. The lid has a recessed portion having formed therein a generally hollow protrusion terminating in a free end which, when the lid sits on the edge portion of the cup, extends into the interior of the cup. The free end is spaced apart from the base. A flexible extraction tube is present, the tube having a first end affixed to the free end of the protrusion and a second end arranged to lie on the base of the cup. The second end of the flexible extraction tube is immersed in a liquid disposed in the cup. When a suction force is applied to the recessed portion of the lid, the hollow protrusion and the flexible extraction tube are operative to transfer the suction force to the liquid, causing liquid to be drawn into the tube and through the protrusion and out of the collection container. 
         [0012]    In a further embodiment of the liquid specimen collection container, the container further includes a transfer means positioned inside the recessed portion of the lid. The transfer means is in liquid communication with the flexible extraction tube and used in transferring liquid from the cup to another vessel. 
         [0013]    In another embodiment of the specimen collection container, the base of the cup has a tapered or slanted shape and the lowest gravitational point of the base is at its center. In variations of this embodiment, the tapered or slanted base has an added depression at its lowest gravitational point. 
         [0014]    In yet another embodiment of the specimen collection container of the present invention, the cup further includes a locking means selected from a group of locking means consisting of a plurality of threads or one or more flanges. In still another embodiment of the specimen container, the base of the cup includes more than one depression. The depressions are distributed substantially circularly on the base. Each of these depressions has the same depth, that depth being the lowest gravitational point on the base. When the lid is in locked engagement with the locking means, one of the depressions is aligned with the recessed portion and the flexible extraction tube extends into and reaches the bottom surface of that depression. In another embodiment of the liquid specimen collection container, the base of the cup further contains a channel connecting the plurality of depressions. 
         [0015]    In another embodiment of the specimen collection container according to the present invention, the flexible extraction tube extends into and reaches the bottom surface of one of the depressions, the depression lying adjacent to the sidewall of the cup and the flexible extraction tube resting against and being partially supported by the sidewall. 
         [0016]    In yet another embodiment of the specimen collection container, the flexible extraction tube has an accordion-like shape. 
         [0017]    In yet another aspect of the present invention there is provided a system for drawing off liquid to be analyzed in a laboratory. The system includes a liquid specimen collection container and a vessel. The liquid specimen collection container includes a cup and a lid. The cup has a base, a sidewall extending substantially transversely from the base, terminating in an edge portion, such that the base and the sidewall form a cavity. The lid is formed for leak-resistant seating on the edge portion. The lid has a recessed portion having formed therein a generally hollow protrusion terminating in a free end which, when the lid sits on the edge portion of the cup, extends into the interior of the cup. The free end is spaced apart from the base. A flexible extraction tube is present, the tube having a first end affixed to the free end of the protrusion and a second end arranged to lie on the base of the cup. The second end of the flexible extraction tube is immersed in a liquid disposed in the cup. The cup also includes a transfer means positioned inside the recessed portion of the lid and in liquid communication with the flexible extraction tube. The vessel is arranged for receiving a sample of liquid drawn from the specimen container. The vessel is in liquid communication with the container by the transfer means and the flexible extraction tube. In the presence of a suction force applied to the transfer means, the transfer means and the flexible extraction tube transfer the suction force to the liquid so as to cause liquid to be drawn into the tube, through the transfer means and into the vessel. 
         [0018]    In an embodiment of the system, the vessel is an evacuated test tube having a closed bottom, an open top, cylindrical sidewalls extending therebetween, and a penetrable membrane attached to the open top. The penetrable membrane is penetrable by the transfer means such that the pressure differential between the container and the test tube allows for liquid to be drawn into the tube via the transfer means and flexible extraction tube. 
         [0019]    In an embodiment of the system, the base of the cup has a tapered or slanted shape where the lowest gravitational point is at the center of the base. 
         [0020]    In another embodiment of the system, the cup further includes a locking means selected from a group of locking means consisting of a plurality of threads or at least one flange. The base of the cup includes a plurality of depressions distributed substantially circularly on the base, each of the depressions having the same depth, that depth being the lowest gravitational point on the base. When the lid is in locked engagement with the locking means, the recessed portion is aligned with one of the depressions and the flexible extraction tube extends into and reaches the bottom surface of that depression. Sometimes, the flexible extraction tube extends into and reaches the bottom surface of one of the depressions, and the depression lies adjacent to the sidewall of the cup with the tube resting against, and being partially supported by, the sidewall. 
         [0021]    In yet another embodiment of the system, the cup further includes a locking means selected from a group of locking means consisting of a plurality of threads or at least one flange. The base of the cup includes a plurality of depressions distributed substantially circularly on the base and the base contains a channel connecting the plurality of depressions. Each of the depressions has the same depth, that depth being the lowest gravitational point on the base. When the lid is in locked engagement with the locking means, the recessed portion is aligned with one of the depressions and the flexible extraction tube extends into and reaches the bottom surface of that depression. Sometimes, the flexible extraction tube extends into and reaches the bottom surface of one of the depressions and the depression lies adjacent to the sidewall of the cup with the tube resting against, and being partially supported by, the sidewall. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]    The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in greater detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. 
           [0023]    In the drawings: 
           [0024]      FIG. 1A  is a schematic side view of a specimen collection container constructed according to a first embodiment of the present invention; 
           [0025]      FIG. 1B  is a schematic top view of the container shown in  FIG. 1A ; 
           [0026]      FIG. 1C  is a schematic side view of a flexible extraction tube which may be used with the container appearing in  FIG. 1A ; 
           [0027]      FIG. 2  is a schematic side view of a specimen collection container constructed according to a second embodiment of the present invention; 
           [0028]      FIG. 3A  is a schematic side view of a specimen collection container constructed according to a third embodiment of the present invention; 
           [0029]      FIG. 3B  is a schematic top view of the container shown in  FIG. 3A ; 
           [0030]      FIG. 3C  is a schematic side view of a flexible extraction tube which may be used with the container appearing in  FIG. 3A ; 
           [0031]      FIG. 4A  is a schematic side view of a specimen collection container constructed according to a fourth embodiment of the present invention; 
           [0032]      FIG. 4B  is a schematic view of the base of the cup of the container shown in  FIG. 4A ; 
           [0033]      FIG. 5  is a schematic side view of a specimen collection container constructed according to a fifth embodiment of the present invention; and 
           [0034]      FIG. 6  is a schematic side view of another embodiment of the flexible extraction tube used in specimen collection containers constructed according to the present invention. 
       
    
    
       [0035]    Similar elements in the Figures are numbered with similar reference numerals. 
       DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0036]    Transferring bodily fluids for laboratory analysis, particularly urine, from a liquid specimen collection container used in collecting these fluids, is difficult in all cases. This is even truer when there is only a small volume of collected fluid. Typically, urinalysis requires samples of at least 5 ccs; multiples of this minimum volume are required when multiple analyses are to be analyzed. 
         [0037]    Patients often find it difficult to provide the required minimum quantity of liquid on demand and samples of smaller than 5 ccs are often collected. In order to use such small samples, a specimen collection container is herein provided which includes a flexible extraction tube. The tube is constructed to reach the bottom of the container and is affixed to a protrusion which extends downward from the lid of the specimen collection container. Such a configuration is absent in prior art where only rigid plastic tubes are used to draw off samples of the collected fluid. Additionally, prior art rigid tubes have lengths that are typically at least 3 mms short of the bottom of the container. 
         [0038]    A flexible extraction tube reaching the bottom of the cup obviates the need for tilting the container when extracting small samples for analysis. Additionally, pressing down on a test tube positioned in a recess of the lid in order to have a rigid plastic tube more closely approach the bottom surface of the container is unnecessary when using the present invention. This prevents damage to the container and its parts and inadvertent injury to a technician from sharp, often biologically contaminated, objects such as needle cannulas or test tubes. It is also envisioned that the specimen collection container constructed according to embodiments of the present invention will allow use of substantially all of the collected fluid, even when the volume of liquid is small. 
         [0039]    In what is discussed and described herein reference is made to urine. However, it is to be understood that the specimen collection containers described herein may also be used in collecting other bodily fluids. 
         [0040]    Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting. 
         [0041]    It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. 
         [0042]    Reference is now made to  FIG. 1A  which shows a side view of a liquid specimen collection container  10 , constructed and operative in accordance with a first embodiment of the present invention. Container  10  includes a cup  11  and a lid  12 . Cup  11  has a generally cylindrical shape and lid  12  is configured to include a cylindrical recess  20 . Cup  11  includes sidewalls  18  extending from base  24  to an open top (not visible), the open top here being covered by lid  12 . Lid  12  may be joined to sidewalls  18  by threads  16  on lid edge  14 . In other embodiments, lid  12  may be joined to the sidewalls  18  of cup  11  by at least one flange-like element extending from the sidewalls  18  of the cup allowing for a snap-on locking engagement. As is readily evident, cup  11  and lid  12  may be made from any of many plastic materials known to those skilled in the art. 
         [0043]      FIG. 1A  shows lid  12  as having only a single cylindrical recess  20 . In other embodiments, more than one recess may be present in lid  12 . As shown in  FIG. 1B , the cylindrical recess  20  in the embodiment shown in  FIG. 1A  is positioned at the center of lid  12 . In other embodiments, as will be discussed below, the one or more cylindrical recesses may be positioned at a distance removed from the center of lid  12 . Additionally, in yet another embodiment, recess  20  may be configured to have a shape other than cylindrical. 
         [0044]    Recess  20  generates a protrusion  23  extending downward into cup  11  in the direction of base  24 . Extending from protrusion  23  is a flexible extraction tube  26  which extends to the base  24  of cup  11 . The increased length of extraction tube  26  allows for substantially greater amounts of liquid to be withdrawn from container  10  even when the container sits level on an external surface. Additional pressure is not required to be placed on an evacuated receiving test tube to bring the flexible extraction tube  26  into closer proximity to base  24 . Additionally, because of the flexibility of tube  26 , if additional pressure would be exerted, damage to container  10  would not occur. Without limiting the materials that may be used in fabricating flexible extraction tube  26 , tube  26  may be made from silicones, polyurethane (PU) rubber or poly vinyl chloride (PVC). 
         [0045]    Flexible extraction tube  26  is sealed to the bottom face  29  of protrusion  23 . Sealing may be effected by hot welding or solvent welding, two techniques both well-known to those skilled in the art of working with polymeric materials. Alternatively, flexible tube  26  may be mechanically joined to protrusion  23  by forcing tube  26  to fit over a fitted portion of protrusion  23 . The above techniques are exemplary methods for joining tube  26  to protrusion  23  and are not deemed to be an exhaustive list. 
         [0046]    Tube  26  is in liquid communication with needle cannula  22  which extends from the bottom of recess  20  in an upward direction toward lid  12  and away from base  24  of cup  11 . Needle cannula  22  is used to pierce an evacuated test tube (not shown) when a sample must be drawn off from container  10 . When not in use, needle cannula  22  is covered by protective needle case  25 , which typically, but without being limiting, is made of silicone rubber. When the evacuated test tube is positioned in recess  20  and pressed down, protective needle case  25  also moves downward exposing needle cannula  22 . The needle is then free to puncture a penetrable membrane covering the mouth of the test tube. After the test tube is filled, the tube is removed, its membrane reseals, and protective needle case  25  moves upward again covering the needle preventing unintentional injuries. The needle cannula  22  is also at times referred to herein as a transfer means. 
         [0047]      FIG. 1B , to which reference is now made, shows a top view of specimen collection container  10  with recess  20  centrally positioned in lid  12 . It should be readily understood, and as will be presented in other embodiments below, recess  20  need not be centrally located but may be positioned away from the center of lid  12 . 
         [0048]    The end of flexible extraction tube  26  closest to the base  24  of cup  11  may have a slanted edge  44  as is shown in  FIG. 1C  now referred to. This slanted configuration however is not intended to limit other possible configurations of tube  26 . 
         [0049]    Reference is now made to  FIG. 2  where a specimen collection container constructed according to a second embodiment of the present invention is shown. Specimen collection container  210  includes all the elements of specimen collection container  10  discussed above in conjunction with  FIG. 1A . These elements are similarly numbered. Additionally, in this second embodiment, the base  24  of cup  11  is slanted or tapered, allowing small amounts of collected liquid to concentrate at tapered end  27 . Tapered end  27  may also include an additional depression  28  which allows for gathering of an even smaller amount of fluid. Flexible extraction tube  26  is positioned so as to reach the bottommost portion of slanted base  24 , and when depression  28  is present, to reach the bottom of depression  28 . Since base  24  is not flat, the sidewalls  18  of cup  11  may extend downward circumferentially forming sidewall extensions  35  allowing for a level stable positioning of container  210  on an external surface. 
         [0050]    A ring (not shown) additionally and optionally may be affixed to sidewalls  18  of cup  11 . This ring would act to further stabilize container  210  allowing it to remain level and stable when placed on a surface. 
         [0051]    Reference is now made to  FIG. 3A  where a specimen collection container constructed according to a third embodiment of the present invention is shown. Specimen collection container  310  includes all the elements of the specimen collection container in  FIG. 1A  and these elements are similarly numbered. Additionally, base  24  of cup  11  of container  310  contains several depressions  39  into which urine may collect from base  24 . 
         [0052]    In the embodiment of  FIG. 3A , recess  20  is positioned off-center of lid  12  and flexible extraction tube  26  extends into the bottom of one of the depressions  39 . As shown by the broken lines in  FIG. 3B , a schematic top view of the container in  FIG. 3A , recess  20  may be positioned in any of three positions, each position approximately 120° apart from its neighbors. Dashed circles  34  represent the other two possible positions of recess  20  as lid  12  is rotated. Dashed line  32  indicates the path of travel of needle cannula  22  when moving between the three locked positions. These positions correspond to the standard three thread lock lids commercially available, which, with only a partial turn of the lid, allows the lid to tightly lock and engage with the cup. In these three positions, flexible tube  26  always extends into one of the three aligned depressions  39  positioned on base  24  of cup  11 . 
         [0053]    In  FIG. 3C , now referred to, flexible tube  26  may have a slanted edge  44  at its end closest to base  24  of cup  11  of container  310 . This slanted configuration, however, is not intended to limit other possible configurations of tube  26 . 
         [0054]    Reference is now made to  FIG. 4A  where a fourth embodiment of the present invention is shown. Specimen collection container  410  includes all the elements of the container in  FIG. 1A  and those of the container in  FIG. 3A  and these are similarly numbered. Additionally, base  24  of cup  11  of container  410  contains a symmetrical circumferential channel  42  ( FIG. 4B ) connecting the several depressions  39  located in base  24  of cup  11 . Once again each of these depressions is aligned with one of the three thread lock positions of lid  12  and recess  20 . Liquid gathers in this channel and then flows into depressions  39 . 
         [0055]    In this embodiment, recess  20  is positioned off center of lid  12  and flexible extraction tube  26  extends into the bottom of one of depressions  39  aligned with recess  20  when lid  12  is in one of its locked positions. As shown in  FIG. 4B , a schematic view of base  24  of cup  11  in  FIG. 4A , each of the three depressions  39  are positioned  1200  apart from its nearest neighbors. As in  FIG. 3B , these positions correspond to and are aligned with one of the locked positions of conventional three thread lock lids commercially available. Only a partial turn of lid  12  is required to tightly lock it with cup  11 . In these three positions, flexible extraction tube  26  always extends and reaches the bottom of one of the aligned depressions  39 . 
         [0056]    A specimen collection container  510  constructed in accordance with a fifth embodiment of the present invention is shown in  FIG. 5 . Specimen collection container  510  is similar to the one shown in  FIG. 3A  or  FIG. 4A  and identical elements are similarly numbered. Again recess  20  is off-center with respect to the center of lid  12 . Flexible tube  26  lies close to sidewall  18  of cup  11  of container  510  allowing it to more easily draw off specimen gathered in depression  39 . Tube  26  may even partially rest on sidewall  18  as shown in  FIG. 5 . Depression  39  may be, and usually is, also positioned very close to sidewall  18  in this embodiment. 
         [0057]      FIG. 6 , now referenced, illustrates another embodiment of the flexible extraction tube. Tube  126  is constructed slightly differently from the tubes  26  shown in  FIGS. 1A-5 . Tube  126  is formed as an accordion-like tube, similar in shape to the shape of the bend in a soda straw. This shape allows for easier access to small volumes of fluid. Tube  126  may be fabricated from the same plastic materials used to produce the flexible extraction tubes  26  shown in  FIGS. 1A-5 . 
         [0058]    In the above embodiments, samples have been described as being drawn off by an evacuated test tube with liquid passing to the test tube via flexible extraction tube  26  or  126  in liquid communication with needle cannula  22 . The evacuated test tube is sized to be insertable into recess  20  during the drawing off process. 
         [0059]    In the embodiments discussed previously, the flexible extraction tube is described as reaching the bottom surface of the container. In other embodiments the flexible tube may be long enough to lie flat along the bottom surface and may even curl back upon itself, possibly curling back even more than once. 
         [0060]    Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. 
         [0061]    Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. 
         [0062]    It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described herein above. Rather the scope of the invention is defined by the claims that follow.