Patent Publication Number: US-6705482-B2

Title: Ball and socket closure

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 08/681,034, filed on Jul. 22, 1996 now abandoned. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to a closure for body fluid collection, transport or storage containers and, more particularly, relates to a ball and socket closure to be used to resealably close a container being used in a laboratory or other clinical environment. 
     2. Background Description 
     After a doctor, phiebotomist or nurse has used an evacuated blood collection tube or other primary tube to draw a primary sample of body fluid from a patient in a hospital or doctor&#39;s office, the primary sample will typically be “poured off” or pipetted into a secondary tube so that the sample can be simultaneously tested in two or more different areas of a clinical chemistry laboratory. For example, the sample may undergo routine chemistry, hormone, immunoassay, or special chemistry testing. In addition, the sample is sometimes “poured off or pipetted” into a secondary tube for overnight storage, to transport the sample from one laboratory to another, or to remove the plasma or serum sample from a separator gel or red blood cells used in the primary tube. When the secondary tube is not being used or is being transported, it is very important to close the open end of the secondary tube with a closure to prevent contamination, evaporation or loss of the sample. 
     Current closures for secondary tubes include plastic caps that snap over or into the secondary tube or cork or rubber stoppers, wherein the stopper is solid and includes a plug portion that fits in the open end of the tube and an enlarged head portion used to remove the closure from the tube using a two-handed method. Such closures provide means for sealing the open end of the tube, but are difficult to remove with two hands and impossible to remove using only one hand. This presents a problem, since the closure must be removed from the tube and discarded prior to placing the tube in a chemical analyzer due to the inability of most sample probes to penetrate any solid closure material. In view of the above, it is desirable to have a closure that can be easily removed from the tube or a closure that can remain on the tube and be easily opened and closed many times for manual sample access and/or during dire sampling by a chemical analyzer. 
     SUMMARY OF INVENTION 
     The present invention overcomes the problems identified in the background material by providing a closure for primary or secondary fluid collection, transport or storage containers or tubes for body fluids that can easily be opened and closed multiple times. 
     A preferred embodiment of a closure according to the present invention includes a bail and socket closure to be used to resealably close a specimen container or s tube used in a laboratory or other clinical environment. In one embodiment, the ball and socket closure is snap-fitted into a tube. The ball has a tab extending therefrom that is pushed by a user approximately 90 degrees to rotate the ball within the socket to a position wherein a passageway through the ball aligns with the opening of the tube and provides access through the closure to the inside of the tube. When the tab is pushed 90 degrees in the opposite direction the ball rotates to close the passageway and seal the open end of the tube for storage to avoid evaporation and for possible access or retest at a later date. 
     An object of the ball and socket closure of the present invention is to provide dirt access to the tube such that a transfer pipette or an analyzer sample probe can access the fluid contents of the tube without the probe contacting the inner surface of the tube or the closure itself. This structure prevents contact or contamination of the probe while maintaining a one handed closure operation. The tab on the ball provides for an easy opening and closing operation with one hand during use which is also a major ergonomic and workflow improvement over existing closures and tubes. 
     Another object of the present invention is to provide a closure having an outer diameter that is no larger than the outer diameter of a current primary specimen collection container with closure (i.e., the VACUTAINER® SST® Brand Tube sold by Becton Dickinson and Company) so that the entire closure and tube assembly can be loaded into conventional analyzer racks, carousels or holders without removing the closure from the tube. Since the closure does not need to be removed from the tube, risk of loss or accidental contamination is minimized. 
     In addition, the ability to use only one closure through multiple samplings rather than replacement of stoppers multiple times reduces cost for the user. 
     In addition, the closure of the present invention is dimensioned to develop a liquid seal that prevents any liquid from leaking out of the tube through or past the ball and socket closure when it is in the closed position. 
     These and other aspects, features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings. 
    
    
     DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of a ball and socket closure according to the present invention assembled with a tube, with the closure in a closed position; 
     FIG. 2 is a perspective view of the ball and socket closure and tube assembly shown in FIG. 1, with the closure in an open position; 
     FIG. 3 is a cross-sectional view of the ball and socket closure and tube assembly shown in FIG. 1 along line  3 — 3 ; 
     FIG. 4 is a cross-sectional view of the ball and socket closure and tube assembly shown in FIG. 2 along line  4 — 4 ; 
     FIG. 5 is a cross-sectional view of the ball and socket closure and tube assembly shown in FIG. 3 along line  5 — 5 ; 
     FIG. 6 is an enlarged cross-sectional view of the ball and socket closure shown in FIG. 5; 
     FIG. 7 is a cross-sectional view of the ball and socket closure shown in FIG. 3 mounted on a small diameter tube; and 
     FIG. 8 is an enlarged cross-sectional view of another alternative ball and socket closure according to the present invention. 
    
    
     DETAILED DESCRIPTION 
     FIG. 1 is a perspective view of a closure  100  according to the present invention assembled with a tube  20 , with closure  100  in a closed position. Tube  20  includes an open top end  21  and an open bottom end  22  with an optional false conical bottom  23  located between top end  21  and bottom end  22 . False conical bottom  23  provides tube  20  with an upper chamber  26  for holding small volumes of liquid. This type of structure allows for easy access to liquid in chamber  26  when utilizing a manual transfer pipette or an automated sample probe from a clinical analyzer. By using false conical bottom  23  the pipette or probe does not need to travel the full length of tube  20  to access the liquid therein. 
     Closure  100  is inserted and snap-fit into open top end  21  of tube  20  and is made of two parts: a ball  70  and a socket  50 . Ball  70  includes a passageway  73  extending theretrough that can be aligned with open top end  21  to provide access to tube  20  or can be moved out of alignment, i.e., by 90 degrees, to prevent access to and seal open top end  21 . A tab  71  extends from ball  70  and is used to rotate ball  70  within socket  50  between a first closed position and a second open position. When tab  71  is in the position shown in FIG. 1, ball  70  is in the first closed position wherein passageway  73  is not aligned with open top end  21  and thereby closing closure  100 . However, when tab  71  is in the position shown in FIG. 2, passageway  73  is aligned with open top end  21  and closure  100  is open. Of course, use of tab  71 , in the present embodiment, is merely exemplary since a protrusion or other type of extension from ball  70  could be used to rotate ball  70 . 
     Tab  71  on ball  70  allows for easy opening and closing of closure  100  with one hand during use, which is an improvement over existing closures and tubes. Existing devices require the operator to remove the closure, place it on the workbench, pour from the primary container into the secondary container and then replace the closure with the second hand. The present invention provides a closure and tube assembly that can be held in one hand while the thumb of that hand is used to open or close the closure. The second hand is then free to pour from the primary container, which clearly simplifies the process and minimizes the risk of loss or spillage of biological fluids. As will be seen and described further below, the open position of closure  100  is also unique since it and no other currently available closure allows access to the liquid or specimen within a tube without having to remove a cap or stopper or penetrate a septum, rubber stopper or membrane. In effect, the present invention provides a “zero penetration force” closure. This improved overall safety and ease of use is important since the nature of the biological specimen routinely handled in laboratories and clinical environments may be infectious. 
     FIG. 3 is a cross-sectional view of closure  100  and tube  20 , shown in FIG. 1, along line  3 — 3  and FIG. 4 is a cross-sectional view of closure  100  and tube  20 , shown in FIG. 2, along line  4 — 4 . As shown in FIGS. 3 and 4, ball  70  includes a pair of annular flat surfaces  72  that together with a pair of corresponding annular flat surfaces within socket  50  provides an axis about which ball  70  rotates within socket  50 . Socket  50  also includes an annular plug portion  51  extending from a lower end of socket  50  that is received in open top end  21  of tube  20 . Plug portion  51  also includes an annular groove  52  on its outer surface that forms a snap-fit with an annular protrusion  25  located on an inside wall  24  of tube  20  just within open top end  21 . The ball and socket closure  100  is snap fit into the open top end  21  of tube  20  when annular plug portion  51  is inserted into open top end  21  and annular protrusion  25  is received within annular groove  52 . Annular plug portion  51  includes an opening  53  therethrough with a shoulder  56  therein for optionally receiving the open end of a small diameter tube  30 , as shown in FIG.  7 . 
     FIGS. 5 and 6 are cross-sectional views of closure  100  and tube  20 , shown in FIG. 3, along line  5 — 5 , and more clearly show the detail of the snap-fit arrangement between annular protrusion  25  on tube  20  and annular groove  52  on annular plug portion  51 . In addition, FIG. 6 shows how outer surface  74  of ball  70  is dimensioned to fit within and interact with inner surface  54  of socket  50  to develop a liquid tight seal at location  75 . The liquid tight seal at location  75  thereby prevents any liquid within tube  20  from leaking out of tube  20  through or past ball  70  and socket  50  when closure  100  is in the closed position shown in FIGS. 1,  3 ,  5  and  6 . In addition, when closure  100  is in the closed position, passageway  73  is perpendicular to passageway  53  and open top end  21  which also prevents access to the inside of tube  20 . 
     Alternatively when closure  100  is in the open position shown in FIGS. 2 and 4, passageway  73  is aligned with passageway  53  and open top end  21  thereby providing access to the inside of tube  20  and releasing the liquid tight seal at location  75 . The internal diameter of passageway  73  and passageway  53  is preferably 10.5 millimeters when the closure is being used on a 16 millimeter primary or secondary tube. Of course, smaller passageways  25  and  73  can be used such as on tubes having smaller outer diameters. However, passageway  53  should at least have an internal diameter of approximately 1.0 millimeter to allow access to fluid through passageway  73  and  53  when the closure is used in combination with smaller diameter tubes or containers or in use with very small bore probes on needles. The preferred internal diameter for a 16 millimeter tube has therefore been selected to be large enough to accept commercially available specimen probes without the probe coming into contact with the interior surfaces of ball  70 , socket  50  or tube  20 . Therefore, the above-noted dimension provides a “zero penetration force” closure. 
     It is also important not to have too large of a passageway  73  and  53 , since the outside diameter of closure  100  or socket  50  must not be too large. If the outside diameter of closure  100  or socket  50  is larger than the outside diameter of a standard primary blood collection tube and closure system, there is an increased risk that tube  20  and closure  100  will not properly fit or function in conventional chemistry analyzer specimen carriers. Therefore, it is preferable to have the outside diameter of socket  50  less than approximately 19.05 millimeters. 
     Closure  100  is easily moved from the closed position shown in FIG. 1 to the open position in FIG. 2 by pushing tab  71  to rotate ball  70  by 90 degrees and thereby align passageway  73  with passageway  53  and open top end  21 . Likewise, when tab  71  is pushed in the opposite direction by 90 degrees ball  70  is rotated to move passageway  73  perpendicular to passageway  53  and close closure  100 . By consistently assembling and orienting closure  100  during manufacturing tab  71  can be placed in a sample tube holder and automatically opened or closed using a robotic arm or device as in an automated laboratory environment. 
     FIG. 7 is a cross-sectional view of the ball and socket closure mounted on a small diameter tube  30 . Tube  30  is smaller than tube  20  but still includes an open top end  31 , an open bottom end  32  and an optional false conical bottom  23  located between top end  31  and bottom end  32 . Open top end  31  is received and press-fit in opening  53  in annular plug portion  51  of socket  50  and abuts a shoulder  56  therein to provide a liquid tight seal between tube  30  and closure  100 . Therefore, the structure of closure  100  provides a very functional “zero penetration force” closure that is flexible enough to be used on two different diameter tubes. 
     FIG. 8 is an enlarged cross-sectional view of an alternative ball and socket closure  200  according to the present invention. In that embodiment, closure  200  includes an annular receiving groove  259  in the lower end of socket  250  for receiving open top end  21  of tube  20 , as opposed to using the snap-fit in closure  100  described above. Annular receiving groove  259  on the lower end of socket  250  is formed by an outer skirt  258  and an inner skirt  251 . Outer skirt  258  extends down the outside of tube  20  and inner skirt  251  extends down the inside wall of tube  20 , when open top end  21  is inserted into annular receiving groove  259 . 
     Otherwise, closure  200  is very similar to closure  100  and includes a ball  270  having a passageway  273  therethrough that can be aligned with a passageway  253  in socket  250 . Ball  270  can be moved from the closed position shown in FIG. 7 to an open position by pushing on a tab  271  extending from ball  270  and thereby rotating ball  270  by 90 degrees. 
     Ball  270  has an outer surface  274  that interacts with an inner surface  254  of socket  260  to provide a liquid tight seal at locations  275  and prevent liquid within container  20  from evaporating, being contaminated, or otherwise passing between socket  250  and ball  270  and out of tube  20 . Ball  270  also includes a pair of flat surfaces (not shown) that interact with a pair of flat surfaces  272  on the inside surface  254  of socket  250  to define an axis about which ball  270  rotates within socket  250 . 
     The above-described closure can be manufactured using many methods, but the best method is by separately molding the ball and socket and then assembling the ball into the socket. The socket is made from an elastomeric like material to allow the large diameter ball to be forced past the socket opening. The material used to make the socket can be. polyethylene or TPE, and the ball can be made of a harder material like styrene or polypropylene. It is also possible to use a “two-shot molding” approach that allows the ball to be molded first and then automatically mold another material over the ball to form the socket. The “two-shot molding” approach has the advantage of saving an assembly step. It is also possible to have the closure manufactured in three pieces, wherein a two-piece socket split in half to receive the ball is assembled around the ball into a single unit. However, of course, these manufacturing techniques and materials are merely exemplary, various other manufacturing methods and materials could also be used. 
     In the foregoing discussion, it is to be understood that the above-described embodiments of the present invention are simply illustrative of various features of closures for a body fluid collection, transport or storage containers. Other suitable variations, modifications and combinations of these features could be made to or used in these embodiments and still remain within the scope of the present invention.