Abstract:
The present invention is a stopper and shield closure assembly 16 millimeter (mm) fluid collection tube whereby the 16 millimeter tube is compatible with conventional needle holders.

Description:
This application claims benefit of provisional application 60/149,580 filed Aug. 18, 1999. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to a stopper and shield closure for fluid collection tubes and more particularly to a stopper and shield closure assembly for 16 millimeters (mm) fluid collection tubes. 
     2. Description of Related Art 
     An evacuated blood collection tube is commonly used by a doctor, phlebotomist or nurse to draw a sample of body fluids from a patient in a hospital or doctor&#39;s office for diagnostic testing. During the use of such a tube, a double-ended needle that is attached to a needle holder, is inserted in a vein of the patient, and the closure end of the evacuated tube is inserted into the open end of the holder until the needle in the holder pierces the tube&#39;s closure. The blood collection tube contains a vacuum that then draws a body fluid sample from the patient into the tube. Therefore, it is important for the closure on the tube to fit securely on the open end of the tube and maintain the vacuum in the tube before, during and after the blood collection procedure. 
     Currently, closures for 13 millimeter or less evacuated blood collection tubes may include plastic shields containing a rubber stopper, wherein the stopper is thick or has an enlarged head to fit snugly within and remain attached to the shield and a plug portion that fits in the open end of the tube. Retention of the stopper in the shield is important when the shield and stopper are being removed from the open end of the tube so that blood within the tube can be tested and when the tube is mated with the end of a double ended needle in a needle holder and body fluid is being obtained from a patient. 
     Standard needle holders, have a fixed internal diameter and accept 13 millimeter or less evacuated blood collection tubes that have a plastic shield containing a rubber stopper. Standard needle holders will also accept 16 millimeter evacuated blood collection tubes that have a rubber stopper and not a plastic shield. Standard needle holders are not compatible with 16 millimeter evacuated blood collection tubes that have a plastic shield that is scaled up from a 13 millimeter tube because the outside diameter of the plastic shield is greater than the internal diameter of the standard needle holder. 
     Therefore, there exists a need to provide a stopper and shield closure on a 16 millimeter tube that is compatible with standard needle holders. 
     SUMMARY OF THE INVENTION 
     The present invention is a specific stopper-shield assembly comprising a plastic shield that is mounted over a rubber stopper for use with a 16 millimeter evacuated tube and that would be compatible with standard needle holders. 
     The present invention provides a stopper and shield closure assembly having an overall diameter the same or similar to that of stopper and shield closure used with 13 millimeter tubes. 
     Most preferably, the stopper-shield assembly of the present invention comprises dimensions whereby use of the stopper-shield assembly with a 16 millimeter plastic tube may be used with a conventional needle holder. The dimensions of the stopper-shield assembly have been minimized to be compatible with conventional needle holders while maintaining the aspects, features and advantages of a stopper-shield assembly that is currently used with 13 millimeter plastic tubes. 
     Most preferably, the two-piece composite closure of the present invention is for use with 16 millimeter plastic tubes. The two-piece composite closure preferably comprises a plastic shield and a rubber stopper. 
     Most notably is that the two-piece composite closure of the present invention comprises an outside diameter that is not proportional to the scale up of the stopper and shield closure assembly that is used with a 13 millimeter tube. 
     An important feature of the stopper and shield closure assembly of the present invention is that the diameter of the assembly allows the closure to fit in conventional needle holders. 
     Another important feature is that the shield material is more rigid than shields commonly used with tubes of 13 millimeters or less. 
     A further notable advantage is that the two-piece composite provides a 16 millimeter tube with a closure that can be used with conventional needle holders. 
    
    
     DESCRIPTION OF THE DRAWINGS 
     FIG. 1 (prior art) perspective view of a 13 millimeter assembly. 
     FIG. 2 (prior art) perspective view of a 16 millimeter assembly. 
     FIG. 3 (prior art) cross sectional view of the container and closure of FIG. 1 taken along  3 — 3  thereof. 
     FIG. 4 (prior art) enlarged cross-sectional view of the assembly of FIG.  3 . 
     FIG. 5 (prior art) enlarged cross-sectional view of the assembly of FIG.  3 . 
     FIG. 6 is a perspective view of the assembly of the present invention illustrating the container with the closure. 
     FIG. 7 is a cross sectional view of the assembly of the present invention of FIG. 6 taken along line  7 — 7  thereof. 
     FIG. 8 is a t op view of the closure of FIG.  6 . 
     FIG. 9 is an enlarged cross sectional view of the assembly of FIG.  7 . 
     FIG. 10 is an enlarged cross sectional view of the assembly of FIG.  7 . 
     FIG. 11 is a cross sectional view of the assembly of the present invention shown in FIG. 7 mounted in a conventional needle holder. 
    
    
     DETAILED DESCRIPTION 
     Referring to the drawings in which like reference characters refer to like parts throughout the several views thereof, FIGS. 1,  3 ,  4  and  5 , illustrate a standard 13 millimeter tube  10  with a stopper  40  and a shield  60  and FIG. 2 illustrates a standard 16 millimeter tube  80  with a stopper  90 . 
     As shown in FIGS. 3 and 4, tube  10  comprises a sidewall  12  having an outer surface  14  and an inner surface  16 . Sidewall  12  extends from an upper portion  18  to a lower portion  20 . Upper portion  18  includes an open end  22  and a rim  24 . Lower portion  20  comprises a closed bottom end  26 . Interior volume  34  extends between top surface  24  and closed bottom end  26 . 
     As shown in FIG. 4, stopper  20  has a radially enlarged upper flange portion  42  and a smaller lower sealing portion  44 . Positioned between upper portion  42  and lower portion  44  is a radial notch  46 . Positioned centrally in the top surface  48  of stopper  20  is a finger well  47 . The bottom surface  49  of stopper  20  is convex. 
     Extending over the top of stopper  20  is a plastic cap or shield  60  which may be comprised of a flexible thermoplastic resin and which includes a radially extending top  62  for extending over the top surface  48  of stopper  20  and an annular skirt  63  extending from top  62 . Radially extending top surface defines an opening  64  through which a needle may pass to be inserted into and through stopper  20 . An integral annular abutment  66  is provided to engage the stopper. Annular abutment  66  includes a tapered surface for ease of assembly of cap  60  over upper flange  42  of stopper  20 . 
     The dimensions of stopper  20  and cap  60  are illustrated in FIG.  5  and are as follows: 
     
       
         
               
               
               
             
           
               
                   
                 TABLE 1 
               
               
                   
                   
               
               
                   
                 DIMENSION 
                 INCHES 
               
               
                   
                   
               
             
             
               
                   
                 A 
                 .217 
               
               
                   
                 B 
                 .442 
               
               
                   
                 C 
                 .225 
               
               
                   
                 D 
                 .013 
               
               
                   
                 E 
                 .028 
               
               
                   
                 F 
                 .215 
               
               
                   
                 G 
                 .061 
               
               
                   
                 H 
                 .018 
               
               
                   
                 I 
                 .019 
               
               
                   
                 J 
                 .041 
               
               
                   
                 K 
                 .126 
               
               
                   
                 L 
                 .021 
               
               
                   
                   
               
             
          
         
       
     
     FIGS. 6 and 7, illustrate the 16 millimeter tube assembly  100  of the present invention. The assembly comprises a tube  120 , a stopper  160  and a shield  180 . 
     As shown in FIGS. 6,  7 ,  8  and  9  assembly  100  of the present invention comprises a tube  120  that comprises a sidewall  122  having an outer surface  124  and an inner surface  126  and extending from an upper portion  128  to a lower portion  130 . 
     Stopper  160  includes a top surface  162 , a bottom surface  164 , a radially enlarged upper flange portion  166  and a smaller lower annular sealing portion  168 . Positioned between upper portion  166  and lower portion  168  is a radial notch  170 . Upper portion  166  defines a top surface  162  wherein a finger well  172  is positioned centrally. The bottom surface  174  of stopper  160  is convex. Although it is within the purview of the invention that bottom surface  174  of stopper  160  is concave. 
     Extending over the top of stopper  160  is a plastic cap or shield  180  which may be comprised of a flexible thermoplastic resin and which includes a top surface  182 , a bottom stop ledge  184 , an annular outer skirt  186  extending from the top surface to the bottom stop ledge. Annular outer skirt  186  has an outer wall surface  188  and inner wall surface  190 . Shield  180  further includes a central opening  192  in top surface  182 . An integral annual abutment  194  is provided to engage the tube. Annular abutment includes a tapered surface for ease of assembly of shield  180  over upper flange  166  of stopper  160 . 
     The dimensions of stopper  160  and shield  180  are illustrated in FIG. 10 measured with reference to said center-line A axis and are as follows: 
     
       
         
               
               
               
             
           
               
                   
                 TABLE 2 
               
               
                   
                   
               
               
                   
                 DIMENSION 
                 INCHES 
               
               
                   
                   
               
             
             
               
                   
                 A 
                 .462 
               
               
                   
                 B 
                 .235 
               
               
                   
                 C 
                 .615 
               
               
                   
                 D 
                 .227 
               
               
                   
                 E 
                 .018 
               
               
                   
                 F 
                 .225 
               
               
                   
                 G 
                 .015 
               
               
                   
                 H 
                 .013 
               
               
                   
                 I 
                 .010 
               
               
                   
                 J 
                 .016 
               
               
                   
                   
                 .032 
               
               
                   
                 L 
                 .016 
               
               
                   
                 M 
                 .129 
               
               
                   
                   
               
             
          
         
       
     
     Most notably is that the dimension H of annular outer skirt  186  of shield  180  is 0.011 to 0.021 and most preferably 0.013, the dimension J of annular abutment  194  of shield  180  is 0.008 to 0.018 and most preferably 0.016, and dimension D of stopper  168  is 0.227 so that a 16 millimeter tube may be used with a conventional needle holder. 
     Therefore as shown in FIG. 11, the 16 millimeter tube assembly of the present invention of FIG. 7, which includes a stopper and a shield, is compatible with a standard needle holder.