Abstract:
The urine collection device of the present invention is an open collection system designed to collect and transfer a liquid urine specimen into a non-evacuated tube through a valve. The device is designed to be user friendly and has a finger placement platform so that one can hold the container without risk of contaminating the inside of the container or becoming exposed to the specimen. The specimen is transferred into the non-evacuated tube when the tube is connected to the valve port. A blunt cannula is used on the collection tube to transfer the specimen thereby avoiding exposure to sharps. The collection tube is attached to the urine collection device at an oblique angle. Gravity allows the specimen to be transferred into the tube and automatically stop at a pre-determined volume based on the oblique angle. The urine collection device with the tube attached may be placed on a flat surface without tipping over. When the filled collection tube is removed from the urine collection device, another tube may be attached for further filling. The self-sealing feature of the valve prevents the remaining liquid from leaking out. The filled collection tube may then be shipped to a laboratory for further analysis.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention. 
     The present invention relates generally to a device and a method for collecting and transferring biological fluids. More particularly, the present invention relates to a device and a method for collecting and transferring a urine specimen in conjunction with a collection tube. 
     2. Description of Prior Art. 
     Biological fluids are collected periodically for laboratory analysis. Laboratory equipment that performs the analysis may only accept biological fluids stored in a test tube. However, a conventional test tube may be too small for the convenient collection of many biological fluids, such as urine. As a result, specimens often are collected in a fairly large container with a widely open top. After collection of the fluid in the container, the container is delivered to a medical technician. The technician then transfers a portion of the fluid to a test tube that can be sealed and transported to a laboratory for analysis. The transfer of biological fluid from the collection container to the test tube is an unpleasant task that creates the risk of contaminating the specimen or exposing the medical technician to potentially harmful pathogens in the specimen. 
     Some biological fluids, such as blood, are collected from patients with assemblies that include a vacuum tube and a double-ended needle cannula. One end of the needle cannula is placed in communication with the biological fluid, typically by piercing the skin of a patient. The opposite end of the needle cannula is urged through a vacuum seal into the vacuum tube. Low pressure within the vacuum tube generates a flow of the bodily fluid through the needle cannula and into the tube. Such vacuum tubes are very convenient and efficient for collecting blood samples. However, for urine specimen collection, vacuum tubes are not very useful because vacuum tubes only have a limited shelf life due to a gradual migration of gas molecules through the walls of the tube. Additionally, sharps or pointed cannula require careful shielding to avoid potential skin punctures. 
     In urine collection, some collection containers have a test tube that is attached. In these devices, a portion of the urine specimen in the container is automatically transferred to the test tube. The test tube then may be separated from the container, sealed and shipped to a laboratory for analysis. However, these prior art assemblies can lead to leakage during the initial collection of the specimen or after the separation of the test tube from the collection container. Additionally, control of the volume of the specimen in the test tube may vary from sample to sample. An improvement for controlling the volume in each specimen sample taken is needed to assure accurate results in the subsequent laboratory analysis. Also, the use of a non-sharp or blunt cannula in the transfer of the specimen from the collection container to the test tube is desired to avoid potential skin puncturing of the medical technician. Also, a collection container designed to avoid contact with the user to prevent contamination of the specimen would offer significant advantages. Prior art assemblies of collection containers can come into contact with the user&#39;s hands during collection which contaminate the specimen in the collection container. Finally, there is a need for a collection container to use a non-evacuated vacuum tube to avoid the potential limited shelf life of the vacuum tube. 
     SUMMARY OF THE INVENTION 
     The invention is directed to a urine collection device for use with a collection tube. Included in the urine collection device is an arcuate base, an open top defining a plane, and a plurality of opposing side walls extending from the base to the open top. The base has a top surface, a bottom surface and a conduit passing therethrough. Inclined is the top surface with respect to the plane. The conduit is located at the lowest gravitational point on the top surface. Further included in the urine collection device is an integrated valve in fluid communication with the conduit and the base. The valve is recessed within the base. The valve is also fixably and angularly attached to the arcuate base such that when the collection tube is attached to the valve, the collection tube is obliquely positioned with respect to the plane for collecting a predetermined volume in the collection tube. 
     The urine collection device preferably further comprises a tube holder fin centrally located on the bottom surface for holding the collection tube during collection. A plurality of releasable snap-fit arms may be disposed on the top surface of the collection device for holding the collection tube during storage of the device. The snap-fit arms are positioned on the top surface to assist in channeling the specimen toward the conduit. 
     A method for collecting and transferring a urine specimen comprises the steps of holding a urine collection device of the type having an arcuate base with an inclined top surface. The top surface leads to a near a low gravitational point on the top surface. A valve angularly attached and recessed in the base is also included in the device. The valve is in fluid communication with the conduit and the base. The next step is holding the urine collection device by a finger placement platform horizontally positioned on the device. The specimen is then collected in the urine collection device is the next step in this process. Next, a collection tube is attached to the device at an oblique angle for filling the collection tube to a predetermined volume. Finally, the collection tube is removed from the device for shipment to a laboratory for analysis. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     A preferred embodiment of the invention is now described in, greater detail by way of reference to the following drawings, wherein: 
     FIG. 1 is an exploded top perspective view of the urine collection device of the present invention in conjunction with a collection tube. 
     FIG. 2 shows an exploded bottom perspective view of the urine collection device of the present invention. 
     FIG. 3 shows an assembled side view of the urine collection device in FIG.  1 . 
     FIG. 4 illustrates a top view of the urine collection device of FIG.  1 . 
     FIG. 5 illustrates a front view of the urine collection device of FIG.  1 . 
     FIG. 6 is a cross-sectional view taken along line  6 — 6  of FIG.  4 . 
     FIG. 7 is an enlarged and exploded view of FIG. 6 unassembled. 
     FIG. 8 is a top view illustrating placement of a lid on the urine collection device with the collection tube stored in the device. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Turning now to the drawings, wherein like numerals denote like components, FIGS. 1-8 depict one embodiment of a urine collection device assembly  10 . Urine collection device assembly  10  comprises a urine collection device  16  and a collection tube  12  removably attached to urine collection device  16 . A specimen collection can be taken either with collection tube  12  attached or not attached to the collection device. Attachment of the collection tube allows the transfer of the specimen from the device to the collection tube for shipment to a laboratory for analysis. If collection tube  12  is attached, immediate transfer of the specimen in urine collection device  16  proceeds into collection tube  12 . Collection tube  12  can then be removed and another tube can be attached if more samples are desired. The advantage of collecting the specimen without tube  12  attached is that the medical technician has control over the transfer of the specimen. This control is especially important if the patient attempts to tamper with tube  12  during collection. 
     Urine collection device  16  includes an arcuate base  14 , an open top  20  which defines a plane “A,” and a side wall  24  extending from base  14  to open top  20 . Arcuate base  14  further includes a top surface  30 , a bottom surface  32 , and a conduit  34  passing through top surface  30  and bottom surface  32 . Preferably, top surface  30  is inclined with respect to plane “A.” Bottom surface  32  may be inclined as well, but it does not have to be inclined for device  16  and assembly  10  to function. However, the purpose of base  14  being arcuate or curved is to impart this incline on top surface  30  and allow the specimen to flow toward conduit  34 . 
     As shown in FIG. 6, conduit  34  is preferably located on base  14  at a region  96  which is the lowest gravitational area on top surface  30 . The purpose for region  96  is to allow the specimen in urine collection device  16  to flow by gravity down top surface  30  and toward conduit  34 . 
     Collection device  16  further includes valve  40  attached to base  14  through conduit  34 . Attachment of valve  40  into conduit  34  allows fluid communication among valve  40 , conduit  34  and base  14 . As the specimen flows toward conduit  34 , it also flows to valve  40 . 
     Valve  40  as shown in FIG. 7, is a closed valve and does not open until a piercing member  84  on collection tube  12  pierces it. Valve  40  self-seals after piercing member  84  is removed so no further specimen flows out of valve  40 . Valve  40  is preferably recessed in base  14  in a recess area  93 . Recessed area  93  has a top area  94  on top surface  30  as shown in FIG.  6 . 
     Top area  94  is inclined in the opposite direction of top surface  30 . This configuration allows the device to be tilted with respect to a flat surface in order to stop the flow of the specimen toward the valve. After the tube is filled to a predetermined volume, tilting the device in an orientation parallel to the tube and away from valve  40  assures the specimen will not flow toward the valve. This stoppage of flow is due to the incline of top area  94  which is in opposite orientation to top surface  30 . Once the tube is removed in this tilted position, valve  40  closes and the device can be set back on the flat surface. Recessing valve  40  provides for protection from any potential exposure to the specimen due to splatter when valve  40  is pierced or when piercing member  84  is removed. 
     Furthermore, valve  40  is preferably fixably and angularly attached to base  14 . As shown in FIG. 3, when collection tube  12  is attached to urine collection device  16 , urine collection device assembly  10  is formed and collection tube  12  is obliquely positioned with respect to plane “A.” Upon attachment of piercing member  84  through valve  40 , collection tube  12  is in fluid communication with valve  40 , base  14 , and urine collection device  16 . This position tilts collection tube  12  at an angle “α” with respect to plane “A.” Angle “α” is defined as the angle formed from the centerline of collection tube  12  to a line substantially parallel to plane “A.” Angle “α” is directly dependent and equivalent to the position of valve  40  with respect to plane “A.” It is the angularity of valve  40  and hence angle “α” that determines the volume of specimen that is transferred from the collection device into collection tube  12 . By changing angle “α,” the volume in collection tube  12  can be varied. Thus, a predetermined volume in collection tube  12  can be calculated or calibrated by changing angle “α” to provide for the desired volume to be transferred. Thus, the oblique position of attached collection tube  12  is characterized by an angle “α” shown in FIG. 3 
     In addition, an alternate volume control for the transfer of the specimen is an air flow tube  106  as shown in FIG.  6 . The air flow tube has a length “L” and a channel  108  that allows the flow of air to escape from the collection tube as the specimen flows into the collection tube. Once the specimen reaches a level where the channel is blocked, the flow of specimen from the device to the collection tube stops. Thus, in addition to varying angle “α”, the length of the air flow tube can be altered to control the desired volume of the specimen to be transferred. 
     Attachment of valve  40  into conduit  34  on base  14  is preferably done by a permanent snap fit design. It is well known to those skilled in the art the various snap fit designs valve  40  and mating conduit  34  may include. Such snap fit designs include cantilever snaps, annular snap joints and discontinuous annular snap joints. In addition, valve  40  may be attached by other methods of assembly known by those skilled in the art. Such methods include ultrasonic welding, heat welding, adhesive bonding, multi-shot molding and in-mold assembly. Valve  40 , alternatively, may be integrally formed on base  14 . Thus, valve  40  and base  14  may be made of the same material and molded together at the same time. Such materials would include ethylene-propylene-dienemonomer, styrene-butadiene block co-polymers, polyisoprene, polyisobutylene, silicone based rubber, polyester based polyurethane, and polybutadiene elastomers. Preferably, valve  40  is a separate component that is attached to base  14 . This feature allows base  14  to be made of a more rigid material than valve  40 . A rigid material is preferred for base  14  because it may provide more structural integrity than having the collection device being made entirely out of an elastomeric material with valve  40 . 
     Urine collection device  16  further includes a tube fin holder  42  centrally located on bottom surface  32  for holding collection tube  12  during collection. Preferably, tube fin holder  42  is a single fin as shown in FIG.  1  and FIG.  2 . However, tube fin holder  42  could be composed of a plurality of fins disposed on bottom surface  32 . The advantage of having a single fin is for ease of attaching and removing collection tube  12 . Tube fin holder  42  provides stability to collection tube  12 . The central location of tube fin holder  42  on bottom surface  32  provides stability of collection tube  12  when it is attached to urine collection device  16 . If the plurality of fins are used, all the fins may be centrally located in order to maintain stability of the test tube. If the fins are not centrally located a balance among the fins must exist to maintain stability. 
     Urine collection device  16  further includes a plurality of snap fit arms  44  disposed and positioned on top surface  30 . Snap fit arms  44  are for providing a secure holding place for collection tube  12  during storage of urine collection device  16 . The collection tube releasably snap fits in the snap-fit arms. 
     A finger placement platform  50  is also included on urine collection device  16 . Finger placement platform  50  is preferably perpendicularly and horizontally mounted to side wall  24 , although other orientations may be employed. Preferably only one platform  50  is mounted to the side wall. However, more than one could be attached to the side wall. The purpose of platform  50  is to provide the user and medical technician a means for holding the urine collection device without risking contamination of the inside of the device. Contamination of the specimen could affect the results of the subsequent laboratory analysis. In addition, the platform reduces the risk of getting the specimen on the user&#39;s or medical technician&#39;s hands. 
     Platform  50  has gripping surfaces  52  disposed on the top and bottom of the platform as shown in FIG.  3  and FIG.  6 . Gripping surface  52  is preferably perpendicularly and horizontally oriented from the side wall. Gripping surfaces  52  assist in holding device  16  giving slip resistant holding to the device. Preferably, the gripping surfaces are on the top and bottom of the platform to provide maximum gripping surface area. However, it is within the scope of the invention to provide a gripping surface on only one side of the platform. 
     Gripping surfaces  52  can be made in many different forms as known by those skilled in the art. These forms include contours, ridges, ribs or bumps molded in platform  50 . Gripping surfaces  52  may also have an abrasive form such as having a slight abrasive surfacing on the platform with a grain size between about 100 to about 220. In addition, the gripping surfaces may have the form of a multi-material overlaying such as having a softer elastomeric material surrounding the harder plastic of the platform. 
     Platform  50  may include a support rib  56  preferably centrally and perpendicularly attached to the bottom of platform  50  and also mounted to side wall  24 , although other orientations may be employed. The function of support rib  56  is to give added strength to platform  50 . In addition, the support rib acts as an additional holding platform to hold device  16 . 
     A planar portion  54  is further included in arcuate base  14  of the urine collection device. Preferably, planar portion  54  is located adjacent to integrated valve  40  as shown in FIG.  2 . The function of portion  54  is to provide flat surface support to urine collection device  16 . Planar portion  54  works by providing a flat surface so the device can rest securely on a corresponding flat surface. This support is available with or without collection tube  12  attached to device  16 . Preferably, finger placement platform  50  is on the same side of device  16  as planar portion  54 . This orientation provides for better ease of use of device  16 . More than one planar portion may be incorporated into the device for added flat surface supports. 
     Planar portion  54  also has a locking platform  60  located beneath finger placement platform  50 . As shown FIG. 5, locking platform  60  has a retaining depression  102  on the outside of the device. FIG. 4 illustrates a top portion  104  located on the inside of device  16 . The function of locking platform  60  is to provide for secure and releasable locking of collection tube  12  to device  16  during sample collection. Locking platform  60  functions by holding the edges of a closure  90  on tube  12  as shown in FIG.  4 . Closure  90  releasably snaps into locking platform  60  to provide releasable and secure locking to tube  12 . A retaining plug  100  on closure  90  inserts into mating component retaining depression  102  for releasable and secure locking of tube  12 . Preferably, retaining plug  100  and retaining depression  102  are mating and releasable snap fits. 
     A plurality of ribs  64  vertically oriented on the side wall is also included in the urine collection device. Ribs  64  assists in securely holding device  16  by allowing the user or medical technician to hold device  16  by side wall  24 . If the ribs are used in addition to the finger platform additional securement of the device is possible. 
     Side wall  24  further may have an oblong shape as shown in FIG. 2, FIG.  4  and FIG.  7 . The shape includes a plurality of depressions  70 . This shape allows the user or medical technician to hold the device in the middle for transport to a flat surface. However, it is preferred that finger placement platform  50  be used for holding device  16  to avoid contamination of the inside of device  16  and avoid exposure to the specimen. 
     Open top  20  is further characterized by having a rim  92  on the top of the side wall as shown in FIG. 7. A lid  62  is attached to rim  92  when urine collection device  16  is in storage. Such attachment methods known to one skilled in the art include heat sealing, adhesive bonding, and snap fitting. The function of lid  62  is to maintain the integrity and sterility of the inside of urine collection container  16 . Lid  62  is removed prior to use. 
     Collection tube  12  of urine collection device assembly  10  further includes a top  72 , a closed bottom  74  and cylindrical side walls  80  extending from closed bottom  74  to top  72 . A cap is disposed on top  72 . The function of cap  82  is preserve the specimen in collection tube  12  after transfer from urine collection device  16  and provide a leak resistant sealing during transport of the specimen to the laboratory for analysis. 
     Cap  82  has a piercing member  84  off centered and protruding from cap  82 . Piercing member  84  is preferably a blunt cannula but may be a sharp-ended needle cannula. Piercing member  84  is in fluid communication with collection tube  12  such that when piercing member  84  pierces valve  40 , the specimen flows through piercing member  84  and into collection tube  12 . Cap  82  further includes a closure  90 . Closure  90  may be hingedly attached to cap  82 . Closure  90  also provides leak resistant protection from the specimen inside collection tube  12  when the closure is rotated and sealed over the cap. When the cap is sealed by the closure a permanent or tamper-resistant seal is formed between closure  90  and cap  82 . Access to the specimen inside collection tube  12 . at this point is only obtained by rotation or removal of cap  82 . 
     As shown in FIG. 6, closure  90  has a retaining plug  100  centered and protruding from closure  90 . The function of retaining plug  100  is to provide secure and releasable locking engagement of collection tube  12  to base  14  and urine collection device  16 . When closure  90  is rotated over to seal cap  82 , retaining plug  100  does not interact with any component of cap  82 . The permanent seal formed between closure  90  and cap  82  and piercing member  84  does not involve retaining plug  100  but only closure  90 . Piercing member  84  is off-centered and retaining plug  100  is off-centered such that there is clearance between both components. 
     During sample collection, retaining plug  100  is inserted into retaining depression  102  for releasable and secure locking of collection tube  12  to base  14  and device  16  as shown in FIG.  5 . Preferably, retaining plug  100  and retaining depression  102  are mating and releasable snap fits. Closure  90  releasably snaps into locking platform  60  to provide additional releasable and secure locking to collection tube  12 . Retaining plug  100  with mating component retaining depression  102  and closure  90  with mating component locking platform  60  provide releasable locking and safety of collection tube  12  during the transfer of the specimen. Locking platform  60  also has a mating and releasable snap fit design in combination with the edges of closure  90 . It is well known to those skilled in the art the various snap fit designs retaining plug  100  has with retaining depression  102  and closure  90  has with locking platform  60 . Such snap fit designs include cantilever snaps, annular snap joints, and discontinuous annular snap joints. 
     Insertion of piercing member  84  into valve  40  also provides some support for collection tube  12 . Alignment of the cap so that the piercing member extends into the valve is done without any difficult manipulation. As shown in FIG. 6, cap  82  slides over valve  40 . Alignment of the piercing member is achieved during insertion by sliding the cap over the valve such that the inside of the cap comes in contact with the valve. Removal of collection tube  12  from device  16  after use is accomplished by depressing closure  90  in a downward direction to disengage retaining plug  100  from retaining depression  102  and closure  90  from locking platform  60 . Piercing member  84  is then removed from valve  40 . Prior to removal of the collection tube, the device is tilted by holding onto the finger placement platform in a direction parallel to the tube and away from valve  40  to assure the specimen will not flow toward the valve. The incline of top area  94  stops the flow of specimen in this position. 
     Materials for the components of urine collection device  16  and assembly  10  are selected from the following groups of materials. Preferably, valve  40  is made of an elastomeric material. Such an elastomeric material includes, but is not limited to, ethylene-propylene-diene-monomer, styrene-butadiene block co-polymers, polyisoprene, polyisobutylene, silicone based rubber, polyester based polyurethane and polybutadiene elastomers. Urine collection device  16  is preferably a unitary structure, excluding attached valve  40 , and is made of a thermoplastic material. Such thermoplastic material includes, but is not limited to, polyethylene, polypropylene, high impact polystyrene and acrylonitrile-butadiene-styrene terpolymer. Collection tube  12  may be made of glass, but is preferably made of a similar thermoplastic material to resist breakage. Cap  82  is preferably made of a similar thermoplastic material as previously listed. Lid  62  can be made of woven polyethylene, paper, or any thermoplastic material. Preferably, lid  62  is made of a material that is permeable to sterilization methods like ethylene oxide gas or gamma and e-beam radiation. 
     Operation of assembly  10  begins with removing lid  62  and taking the tube out of the device by releasing the tube from the snap-fit arms. Use of the assembly begins with holding finger placement platform  50  and collecting the specimen inside device  16  through open top  20 . Collection can occur with or without collection tube  12  attached because valve  40  is a closed valve. Valve  40  does not open until pierced by piercing member  84  on cap  82 . Thus, no leakage or spills of the specimen occurs if collection tube  12  is not attached to device  16  prior to collection. After the specimen is collected, if collection tube  12  is not attached, it is attached either by the user or medical technician. Preferably, this operation of attachment is done by the medical technician to provide control over the transfer process and minimize the risk of contamination of the specimen from user tampering. Piercing member  84  on cap  82  punctures valve  40  so that collection tube  12  is in fluid communication with urine collection device  16 . Piercing member  84  is preferably a blunt cannula to reduce the risk of injury. When piercing member  84  has entered valve  40 , collection tube  12  is positioned and attached to device  16  at an oblique angle to arcuate base  14  for filling collection tube  12  to a predetermined volume when the device is held level or placed on a flat surface. Altering the angle of tube  12  relative to plane “A” can vary this predetermined volume. Once the required volume of specimen is transferred the device is tilted by holding the finger placement platform and tilting the device in the direction away from valve  40  and parallel to the tube. The incline of top area  94  stops the flow of the specimen towards the valve. The tube is then removed. Once piercing member  84  is removed, valve  40  self-seals and prevents further transfer of the specimen out of device  16 . The device can be positioned back on a flat surface. Closure  90  is then rotated over cap  82  to form a permanent seal. Collection tube  12  is now ready for shipment to a laboratory for analysis. Another tube can be attached to device  16  if additional specimen samples are desired. 
     The embodiment depicted in FIGS. 1-7 is intended to be merely exemplary, and is not intended to depict all possible shapes for a collection device of the present invention. Rather, collection tube  12  and integrated valve  40  can be used with any shaped collection device that has mating components such as locking platform  60  and retaining depression  102  locking platform  60  and retaining depression  102  provide releasable locking and safety during the transfer of the specimen. 
     The present invention allows control over the volume of specimen transferred into collection tube  12  by the angle and position of valve  40  when the device is held or placed at a level orientation. In addition, collection tube  12  is securely and releasably attached during sample collection to urine collection device  16 . Thus, the present invention enables the specimen to be transferred at various volumes while providing safety from spills or leakage by controlling the angle device  16  holds collection tube  12 .