Patent Publication Number: US-2005133396-A1

Title: Biological specimen collection container

Description:
FIELD OF THE INVENTION  
      The present invention relates to a biological specimen collection container and in particular to a biological specimen collection container having an integral closure indicator to indicate when the container is properly sealed.  
     BACKGROUND OF THE INVENTION  
      Biological specimen containers serve to assure the integrity of the biological specimen being collected for testing as well as to protect the health care professional or handler from the possible pathogens in the container. The safe handling of biological specimens has become increasingly critical in view of the increase in both the number and severity of potential hazards associated with the handling of such specimens. The onset of acquired immunodeficiency syndrome arising from infection by the highly contagious HIV virus has resulted in increased awareness of the need for safe handling of biological specimens. This factor, along with such factors as potential infection from hepatitis virus and the increased awareness of the carcinogenic properties of substances in common medical use has created a demand for biological specimen containers that are of reasonable cost and readily sealed.  
      There are at present many plastic biological specimen containers in use, particularly those manufactured of polypropylene. Polypropylene has many of the required characteristics such as high resistance to leakage, chemical or biological infiltration, moderate cost, resilient yet substantially inert, stable at temperatures of normal use and relatively safely incinerated. However, polypropylene does have a tendency, when it is elastically deformed at pressure points such as the seal to gradually drawback from the pressure point thereby reducing the contact seal, resulting in increased susceptibility to leakage. In order to provide for this proper seal it is necessary that the cap or lid of the container be securely and completely screwed down. If this is not done, then the cap or lid may release and allow leakage of the contents of the container.  
      There have in the past been some proposals for ways to indicate that the lid is completely sealed. One example of such a system is shown in United States patent number which describes a paper label placed on the lid and container for indicating when the container is properly sealed. However this system has a drawback in that should the label be removed from the lid or container the indication of proper sealing is no longer present  
      There thus remains a need for a simple way of indicating that a biological specimen container has been properly sealed.  
     SUMMARY THE INVENTION  
      The present invention provides for a biological specimen collecting container for holding a biological specimen in a long-term sustained and sealed environment. The biological specimen collecting container comprises a container for holding the biological specimen and a sealing closure. The container is of circular section and has a generally vertical side wall, the side wall at the top being provided with a first thread on an exterior surface thereof. The sealing closure has a peripheral groove to receive the container rim, an outer wall of the closure being provided with a second thread complementary to the first thread on the container for engagement therewith. The exterior of the outer wall of the sealing closure is provided with an integral indicator. The exterior wall of the container below the first thread is provided with an integral indicator in a position such that when the indicator of the closure lines up with the indicator on the container, the cap is secure and the container is closed and sealed.  
      In an aspect of the invention, the integral sealing indicator is selected from a solid arrow shape, a triangle, square, rectangle and a plurality of vertically extending raised indicator bars or other shape which serves as an indicator on the vial portion of the container. The indicator on the cap may be a bar, an arrow or other shape to indicate the position of the cap relative to the container.  
      In another aspect of the invention the integral indicator on the exterior wall of the container is a plurality of vertically extending raised indicator bars spaced along the outer wall, the bars increasing in length in the direction of closure of the cap.  
      In another aspect of the invention the cap is provided with two integral indicator bars 180° apart on the exterior of the cap  
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      A preferred embodiment of the present invention is illustrated in the attached drawings in which:  
       FIG. 1  is a perspective view of a biological collection container in accordance with the present invention;  
       FIG. 2  is a side view of the container of  FIG. 1  in the process of being closed;  
       FIG. 3  is a side view of the container of  FIG. 1  in a closed configuration;  
       FIG. 4  is a a perspective view of a second embodiment of a biological collection container in accordance with the present invention; and  
       FIG. 5  is a side view of the container of  FIG. 4  in a closed configuration. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
      A preferred embodiment of the biological specimen collection container of the present invention is illustrated in the attached figures. A container  10  is provided for holding a biological sample, the container  10  being closed and sealed by a sealing closure cap  12  as illustrated in the drawings. The container  10  and closure cap  12  are engaged and held in engaged relationship by the use of complementary threads comprising a first thread  14  provided on the exterior of the container  10  and a second thread  16  provided on the interior of the outer wall of the cap  12 .  
      The container  10  is circular in section having a vertical side wall  18 , a bottom  20  and an open mouth  22  defined by a rim  24 . The side wall  18  below the rim is provided with a first thread  14  and below the thread  14  is provided an integral sealing indicator  26 , the function of which will be explained further below. In a preferred embodiment illustrated in the figures, the integral sealing indicator  26  is provided as a plurality of individual vertically oriented raised lines on the exterior wall which increase in length in the direction of closure of the closure cap  12 .  
      Closure cap  12  has a peripheral groove  28  to receive the container rim  24 , the groove  28  being defined by an outer wall  30 , inner wall  32  and a top  34 . The interior of the outer wall  30  is provided with a second thread  34 , complementary to the first thread  14  on the exterior of the container  10 . The closure cap  12  also has a crown portion  36  and a connection portion  38  extending between the crown portion  36  and the inner wall  32  of the groove  28 . The exterior of the outer wall  30  is provided with an integral sealing indicator  40 , the function of which will also be explained below. In the preferred embodiment illustrated in the figures, closure cap  12  is provided with two integral sealing indicators  40  located 180° apart on the exterior of the outer wall  30 .  
      When one wishes to close and seal the biological specimen container of the present invention, the closure cap  12  is placed on the top of the container  10  and turned in a clockwise direction to allow the complementary threads  14  and  34  to engage one another and thereby seal the container. The indication of cap closure is evident by the position of the indicator  40  on the closure cap  12  relative to the indicator  26  on the container  10 . When the indicator  40  of the closure cap  12  is positioned over any portion of the indicator  26  of the container  10 , the closure cap  12  is secure and the container  10  is closed. By providing the indicator  26  on the container  10  as a plurality of individual bars increasing in length the positive engagement of the cap to the container of at least 95 kPa may be indicated. When the indicator  40  on the closure cap is  12  turned completely to the left of the indicator  26  on the container  10 , the sealing is 95 kPa compliant.  
      Several indicator positions, such a one to four or more, however for clarity one or two position points are preferred. As a product label may obscure on of the indicators a minimum of two indicators is preferred.  
      The indicator profiles are machined into the steel molds thus the locations of the indicator profiles on the plastic vials and caps are located precisely.  
      The integral indicators  26  and  40  of the present invention are easily formed during the molding of the container  10  and closure cap  12  respectively. As the closure indicators are integral to the cap or container, there is no risk of the indicators becoming dissociated from the container and thus as they are always associated with the container, the user of the container always knows if the container is properly sealed. In addition, as the closure indicators are formed during the molding operation, the required position of the indicators is easily determined. One does not have to first securely seal the container and then attach an external closure indicator as in the prior art. This separate step is susceptible to error if the container has not been properly closed prior to attachment of the external closure indicator.  
      Although various preferred embodiments of the present invention have been described herein in detail, it would be appreciated by those skilled in the art, that variations may be made thereto without departing from the spirit of the invention of the scope of the appended claims.