Abstract:
A biological fluid collection device with a pivotable faucet is disclosed. The device is designed to collect, hold and transfer a biological specimen into a non-evacuated tube through an integrated pivotable faucet component. This device uses no needles, either blunt or sharp, and provides safety from needle puncture. The device works with a non-evacuated tube and a specially designed cap that attaches to the container via the pivotable faucet. The device includes a container for collecting, holding and transferring the biological fluid. The design of the container facilitates use of the tube as a handle in order to position the container to receive collection of the biological fluids. The method of collection begins with using the non-evacuated tube as a handle to hold the container and collecting the biological specimen in the container. A lid is attached to the top of the container to prevent contamination and exposure to the specimen during transfer into the non-evacuated tube. The non-evacuated tube is rotated and stopped in place by a detent. The transfer of the biological fluid is without any contact to the liquid specimen. Gravity allows the liquid to transfer. Liquid transfer is stopped by rotation of the tube and pivotable faucet. The tube is rotated back to its original position as a handle and pulled off the container. The second tube may be filled at that time or the container can be discarded for proper disposal.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of Invention 
     The invention relates generally to an apparatus for collecting and transferring biological fluids. More particularly, the present invention relates to a biological fluid collection device with a pivotable faucet for collecting and transferring a fluid specimen to 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 test tube is 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. 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 collection tube that can be sealed and transported to a laboratory for analysis. The transfer of biological fluid from the collection container to the collection 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. 
     In urine specimen collection, vacuum tubes are usually not very useful because vacuum tubes usually have a limited shelf life due to a gradual migration of gas molecules through the walls of the tube. Some prior art collection containers have a test tube that is attached. In this prior art device, a portion of the specimen in the container is automatically transferred to the tube. The 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. A means 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 tube is preferred to avoid potential skin puncturing of the medical technician. A collection container designed to avoid human contact during transfer of the specimen is desired in order to prevent specimen contamination. Also, 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 present invention alleviates in great part the drawbacks associated with the prior art biological fluid collection devices. Provided is a biological fluid collection device comprising a container for holding the fluid having an upper open portion, a lower portion and side walls therebetween. The container further includes an orifice through the container at a low gravitational point inside the container. A projecting faucet pivotably attached to the container is also provided. The faucet is in fluid communication with the orifice. The orifice and faucet can be disposed on either the lower portion or side walls. The pivotable faucet has closed and open positions. Because the faucet has open and closed positions, pivoting or rotation of the faucet controls the fluid transfer from the container. 
     Further included in the device is a tube having a closed bottom, an open top and side walls therebetween. The tube used in the biological fluid collection device is preferably non-evacuated. However, an evacuated tube may be used in this device. The tube further includes a cap disposed on the open top. The cap has an off-centered hole therethrough for receiving the pivotable faucet in releasable locking engagement. Thus, no needles, either blunt or sharp, are used in the transfer of the fluid from the container to the tube. The cap on the test tube further includes a closure lid hingedly attached to the cap for permanently sealing the cap after fluid collection. A plug on the closure lid mates with the hole in the cap to provide a leak-resistant seal. 
     The faucet rotates in a closed position when the tube is used as a handle for holding the container during collection. The faucet is rotated in the open position when the fluid flows through the hole into the tube. When the orifice and pivotable faucet are disposed on the lower portion, the biological fluid collection device can further comprise an annular skirt attached to the lower portion. The annular skirt has a planar bottom for flat surface support. The annular skirt further includes a recessed portion for securing the tube in the closed position. Also included in the biological fluid device, when the orifice and faucet are disposed on the lower portion, is a detent mounted on the annular skirt. The purpose for the detent is for securing the tube in the open position. The detent also has a planar bottom for assisting in flat surface support. 
     When the orifice and pivotable faucet are disposed on the side walls of the container, the side walls have a recessed portion for securing the tube in the closed position. In this embodiment, the lower portion is substantially planar for providing flat surface support. 
     The biological fluid collection device further comprises a lid disposed on the upper portion of the container for protecting the fluid in the container from contamination. The lid on the biological fluid collection device further comprises a vent which allows air flow during the transfer process to the tube. The vent contains a membrane which is disposed on the lid. The membrane allows the air flow through the vent and prevents fluid flow through the lid. 
     The biological fluid collection device can further include depressions on the side walls for assisting and gripping the container. The container could also include snap fits mounted to the lower portion to hold the tube during storage. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The invention is now described in greater detail by way of reference to the following drawings wherein: 
     FIG. 1 is an exploded front perspective view of the biological fluid collection device with a pivotable faucet of the present invention. 
     FIG. 2 shows an assembled back perspective view of the biological fluid collection device in FIG.  1 . 
     FIG. 3 shows a front view of the biological fluid collection device of FIG.  2 . 
     FIG. 4 illustrates a side view of the biological fluid collection device of FIG.  2 . 
     FIG. 5 is an exploded front perspective view of the biological fluid collection device in FIG. 2 in conjunction with a tube. 
     FIG. 6 is a side view of the biological fluid collection device assembled with a tube positioned in the closed position. 
     FIG. 7 is a side view of the biological fluid collection device assembled with a tube in the open position. 
     FIG. 8 is a cross-sectional view of FIG.  6 . 
     FIG. 9 is a cross-sectional view of FIG.  7 . 
     FIG. 10 is a perspective view of an alternate embodiment of the biological fluid collection device in FIG. 6 in the closed position. 
     FIG. 11 is a side view of the device in FIG. 10 in the open position. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Turning now to the drawings, wherein like numerals denote like components, FIGS. 1-11 depict a biological fluid collection device with a pivotable faucet generally shown as numeral  8 . Device  8  comprises a container  10 , a tube  40 , and a projecting faucet  30 . Container  10  is for collecting, holding, and transferring the fluid. Container  10  has an upper portion  12 , a lower portion  14 , and side walls  20  therebetween. Preferably, side walls  20  are cylindrically shaped. However, such a shape is not necessary for device  8  to function. Other such shapes for side walls  20  include oblong shaped, elliptical shaped, contoured shaped, and rectangularly shaped side walls. Container  10  further includes an orifice  22  through container  10 . Orifice  22  is located at a low gravitational point  24  inside container  10 . Low gravitational point  24  need not be the lowest gravitational point in container  10  for device  8  to function. All that is needed for device  8  to transfer the fluid within is that orifice  22  is at a low gravity point. 
     Projecting faucet  30  is pivotably attached to container  10  and in fluid communication with orifice  22 . Pivotable faucet  30  has a closed position  32  and an open position  34  as shown in FIGS. 6 and 7, respectively. Orifice  22  and pivotable faucet  30  are preferably disposed on lower portion  14 . However, orifice  22  and pivotable faucet  30  may be disposed on side walls  20  as shown in FIGS. 10 and 11. 
     Pivotable faucet  30  is further characterized as shown in FIG. 5 to include a conduit  36  therethrough, a male distal end  38  and a proximal end  39 . Male distal end  38  attaches to a cap  52  on tube  40 . Cap  52  has a hole  54  which male distal end  38  enters into for secure and releasable attachment. Hole  54  is off-centered to provide maximum clearance for attachment of tube  40  to container  10  and for tube  40  to pivot. Thus, no needle cannula, either sharp or blunt, is required for the transfer of fluid from container  10  to tube  40 . Preferably, tube  40  is attached to container  10  prior to collection. However, tube  40  does not have to be connected to container  10  for device  8  to function. If tube  40  is not attached to container  10  during collection, faucet  30  must be in closed position  32 , otherwise fluid comes out of male distal end  38 . Thus, after tube  40  is removed from container  10  when transfer is completed, fluid will leak out unless faucet is placed in closed position  32 . This attachment is seen in FIG.  8  and FIG.  9 . Faucet  30  also has a pivot point  35 . When faucet  30  is pivoted about point  35  and conduit  36  at proximal end  39  is in fluid communication with orifice  22 , faucet  30  is opened and fluid transfer from container  10  commences. Conversely, when faucet  30  is pivoted so that conduit  36  at proximal end  39  is not in fluid communication with orifice  22 , faucet  30  is closed and no fluid transfer commences. Thus, pivotable faucet  30  controls the amount of fluid that is transferred out of container  10 . 
     Tube  40  as shown in FIGS. 5-9 is further included in device  8 . Tube  40  is characterized by a closed bottom  42 , an open top  44  and cylindrical side walls  50  therebetween. Preferably, tube  40  is a non-evacuated tube for collection purposes. However, an evacuated tube may be used. A non-evacuated tube is preferred because there is no shelf-life for the vacuum which pulls the fluid in the tube. In the present invention, gravity pulls the fluid from container  10  into tube  40 . Tube  40  further includes cap  52  disposed on open top  44 . There are many methods for cap  52  to be disposed on open top  44 . Such methods include thread attachment, snap-fittings, and mechanical fasteners. 
     Hole  54  is through cap  52  for receiving male distal end  38  of faucet  30  in releasably locking engagement. Hole  54  is off-centered with respect to the center point of cap  52 . The function of this geometry is to provide maximum clearance for tube  40  to pivot when tube  40  is connected to faucet  30 . Faucet  30  is in closed position  32  when tube  40  is perpendicular to container  10 . Tube  40  is then used as a handle  60  for holding container  10  during collection. Faucet  30  is rotated in open position  34  when fluid flows through hole  54  into tube  40 . Rotation of faucet  30  is enabled by pivoting tube  40 . 
     Lower portion  14  is characterized by an annular skirt  16 . Annular skirt  16  is attached to the bottom of lower portion  14 . Preferably, in this embodiment, annular skirt  16  and lower portion  14  are a unitary structure and made of the same material. However, both may be separate components mounted together. Methods for mounting include ultra-sonic welding, adhesive bonding, and mechanical fasteners. Annular skirt  16  is further characterized by having a planar bottom  18  for flat surface support. Thus, device  8  can be placed on a flat surface without tipping over. Annular skirt  16  is also characterized by having a recessed portion  62  for securing tube  40  in closed position  32 . 
     A detent  64  is further included on annular skirt  16 . Detent  64  is mounted on the back end of annular skirt  16  opposite recessed portion  62  for securing tube  40  in open position  34 . Detent  64  has a planar bottom  19  for flat surface support with planar bottom  18  of annular skirt  16 . Such structures are shown in FIG.  4 . The function of detent  64  is to prevent further backward motion of tube  40  when pivoted into open position  34 . Detent  64  also provides support to tube  40  when in open position  34 . 
     Annular skirt  16  is further characterized by having an open area  65  adjacent to detent  64 . Open area  65  is preferably rectangular in shape but is not limited to such a shape for device  8  to function. Other such shapes include semi-circles, triangles and elliptical shapes. A rectangular shape is preferred for open area  65  so that side walls  50  of tube  40  creates a frictional fit on the inner walls of open area  65 . This frictional fit assists in the stability of tube  40  during transfer. Open area  65  also functions as a space for tube  40  to sit when in position  34 . 
     Alternatively, orifice  22  and pivotable faucet  30  are disposed on a side wall  120  as shown in FIGS. 10 and 11. In this alternate embodiment, side wall  120  is further characterized by having a recessed portion  63  for securing tube  40  in a closed position  142  as shown in FIG.  10 . This alternate embodiment is generally described as a container  110 . Container  110  has a storage lid  94  disposed thereon. 
     Container  110  is characterized by an upper portion  112 , a lower portion  114  and oblong side walls  120  therebetween. Storage lid  94  is disposed on upper portion  112 . Preferably, storage lid  94  is a woven polyethylene material heat sealed on upper portion  112 . However, storage lid  94  can be made of various thermoplastics. Such materials include polyethylene, styrene, polypropylene and polyester. Other attachment methods include snap fits, adhesive bonding and mechanical fasteners. 
     Lower portion  114  is characterized by having a substantially planar bottom  70  for providing flat surface support for container  110 . Lower portion  114  further includes an array of snap fits  92  as shown in FIG.  10 . The function of snap fits  92  is to hold tube  40  when container  110  is in storage prior to use. Preferably, snap fits  92  and container  110  are a unitary structure. However, snap fits  92  can be a separate component and be attached to lower portion  114  by several methods known to those skilled in the art. Such methods include heat welding, adhesive bonding, mechanical fasteners, ultrasonic welding, and snap fittings. 
     Side walls  120  is characterized by having a pair of depressions  90  as shown in FIG.  10  and FIG.  11 . Depressions  90  allow the user to ergonomically and safely grasp container  110  without contaminating the fluid specimen inside. 
     In the preferred embodiment shown in FIGS. 1-9, container  10  has a lid  72  disposed on upper portion  12  for protecting the fluid in container  10  from contamination. In the alternate embodiment shown in FIGS. 10-11, storage lid  94  is disposed on upper portion  112  for protecting the contents inside container  110  prior to use. Such contents include tube  40  in snap fits  92 . Unlike protective lid  72 , storage lid  94  is not re-attached after collection. Protective lid  72  is placed on upper portion  12  after the specimen collection has been taken. 
     Protective lid  72  is further characterized by having at least one internal projection  82  for lockingly engaging at least one external projection  80  on side wall  20 . External projection  80  is adjacent to upper portion  12 . Preferably, internal projection  82  and external projection  80  are matching threads. However, it is within the purview of the invention for internal projection  82  and external projection  80  to be matching snap fits, or mechanical fasteners. In addition, internal projection  82  may be on side walls  20  and external projection  80  may be on lid  72 . 
     When protective lid  72  is disposed on upper portion  12 , a permanent and leak-resistant seal is formed. This seal prevents re-opening of lid  72  after collection of the biological fluid in container  10 . The leak-resistant seal enables container  10  to provide safety from leaks or spills when the fluid is transferred into tube  40 . After transfer, tube  40  is transported to the laboratory instead of container  10 . Lid  72  provides protection from the biological fluid inside container  10  and protects the fluid specimen from contamination. 
     Protective lid  72  is further characterized by a plurality of ribs  73  circumferentially disposed on the edges of lid  72 . Side walls  20  further includes a plurality of vertical ribs  21  also circumferentially disposed around the outside of container  10  adjacent to upper portion  12 . The function of ribs  73  and vertical ribs  21  is to allow gripping of lid  72  and container  10  when attaching to form the permanent and leak resistant seal between lid  72  and container  10 . 
     Cap  52  is further characterized by comprising a closure lid  74  hingedly attached to cap  52  for permanently sealing cap  52  after fluid collection. Closure lid  74  further includes a plug  75  off-centered from the center point of closure lid  74  to attach inside off-centered hole  54  of cap  52 . A hinge  76  attaches closure lid  74  to cap  52 . When plug  75  attaches to hole  54 , a permanent and leak-resistant seal is formed. Tube  40  with transferred fluid from container  10  is transported to a laboratory for analysis with this safety feature which resists leaking or spilling fluid. There are many methods plug  75  can attach to hole  54 . Such methods include matching snap fits, mechanical fasteners and latches known to those skilled in the art. 
     As shown in FIGS. 8 and 9, protective lid  72  it is further characterized by including a vent  84  for allowing air flow therethrough. Vent  84  includes an orifice  85 . Fluid and air can penetrate orifice  85 . A membrane  86  is disposed on the top of lid  72  to facilitate air flow from vent  84  during collection. Membrane  86  prevents fluid from escaping or penetrating while allowing air to permeate. Membrane  86  is disposed on lid  72  rather than in vent  84  to provide maximum air flow through orifice  85  and vent  84 . Fluid is prevented from flowing through the rest of the lid  72  by membrane  86 . 
     Operation of biological fluid collection device  8  begins with collecting a specimen in container  10 . Collection can occur with or without collection tube  40  attached because pivotable faucet  30  has a closed position  32 . Preferably, test tube  40  is attached to container  10  so that test tube  40  can be used as handle  60  during the collection process. After collection has taken place, protective lid  72  is disposed on upper portion  12  to prevent contamination and exposure to the specimen in container  10 . Tube  40 , if not attached, is attached to the container  10  by inserting hole  54  over male distal end  40  in releasably locking engagement. Male distal end  40  has a luer taper to match with hole  54  which has a corresponding taper. In closed position  32 , closed bottom  42  of test tube  40  is perpendicular to container  10 . Rotation of tube  40  towards recessed portion  62  allows pivotable faucet  30  to be in open position  34 . In open position  34 , closed bottom  42  of tube  40  is lower than lower portion  14  and fluid begins to flow through hole  54  and into tube  40 . Once a sufficient amount of specimen has been transferred into tube  40 , tube  40  is then rotated back into closed position  32 . In closed position  32 , no fluid is transferred from container  10 . Tube  40  is then removed from pivotable faucet  30  and closure lid  72  is rotated on cap  52  such that plug  75  enters hole  54  for permanent and leak-resistant sealing. At this point, tube  40  is ready to be shipped to a laboratory for further analysis. Another tube may be attached to container  10  in a similar manner if more specimen samples are desired. 
     Test tube  40  can also be used with alternate collection container  110  as shown in FIGS. 10 and 11. Container  110  includes orifice  22  through side walls  120  at a low gravitational point inside container  110 . Side walls  120  has recessed portion  63  for supporting tube  40  in closed position  142 . Like the preferred embodiment, this alternate embodiment allows tube  40  to be used as a handle during the collection process. Container  110  is further characterized by having snap fits  92  mounted to lower portion  114  to hold tube  40  thereon during storage. Storage lid  94  is disposed over upper portion  112  and is removed before collection commences. Storage lid  94  is not replaced on upper portion  112  after the collection process has been completed. Side walls  120  further includes depressions  90  for assisting and gripping container  110 . 
     Pivotable faucet  30 , as shown in FIGS. 10 and 11, is rotated into closed position  142  and into recessed portion  63  when closed bottom  42  of tube  40  is above upper portion  112 . Tube  40  again can be used as a handle for container  110  during collection. After collection, pivotable faucet  30  is rotated away from recessed portion  63  in an open position  144 . Open position  144  is shown when closed bottom  42  of tube  40  is lowered for the fluid to flow through hole  54  and transfer into tube  40 . Tube  40  can be rotated back into closed position  142  after the desire volume is transferred into tube  40 . Tube  40  is removed and subsequently sealed by closure lid  74 , similar to the preferred embodiment, for transport to a laboratory for analysis. At that point, another tube can be attached to container  110  if further specimen samples are desired. For both embodiments, it is preferred not to have faucet  30  in open position  34  or open position  144  during collection. Both embodiments preferably should have faucet  30  in closed position  32  or closed position  142  during collection in container  10  or container  110 . This procedure is preferred because it reduces the risk of specimen leaks or spills during collection. During transfer into tube  40 , faucet  30  is opened. 
     The embodiments depicted in FIGS. 1-11 are intended to merely be exemplary. They are not intended to depict all possible collection containers. Rather, pivotable faucet  30  and tube  40  can be used with any containers having the appropriate dimensions for mating male distal end  38  into hole  54 . Pivotable faucet  30  can also be used in any desired angle of orientation. The present invention is able to control the volume of specimen transferred into tube  40  by pivotable faucet  30  without creating a potential for leakage or spills and without the use of blunt or sharp cannula. Thus, the present invention improves the safety and transfer control in biological fluid collection devices by eliminating the use of piercing members and controlling the transfer of the biological fluid by a pivotable faucet.