Oral fluid, saliva and sputum collection device and method

Abstract

Disclosed herein are devices and methods for collecting oral fluids, saliva, or sputum. One exemplary device includes a collection cup with a hollow needle extending from a bottom end of the cup, where the hollow needle is covered with a compressible sleeve. A clear vacuum tube is positioned beneath the hollow needle. Oral fluids, saliva, or sputum from a donor are collected into the collection cup, and the vacuum tube is pushed onto the hollow needle and the hollow needle passes through the compressible sleeve, through a seal of the vacuum tube, and into the vacuum tube. Oral fluids, saliva, or sputum from the collection cup are drawn into the vacuum tube until the vacuum in the vacuum tube dissipates. An oral fluid specimen is, thus, provided ready for laboratory transport, point of collection screening, or diagnostic analysis while the oral fluid specimen is still in the transparent vacuum tube.

What is claim: 
     
         1 . An assembly for collecting oral fluids, saliva, or sputum, comprising:
 a housing having a top end and a bottom end;   a collection cup attached to the top end of the housing, the collection cup comprising:
 a top end; 
 a bottom end; and 
 one or more openings extending through the bottom end of the collection cup; 
   one or more hollow needles each aligned with one of the one or more openings in the bottom end of the collection cup and extending from the bottom end of the collection cup into an interior of the housing;   one or more vacuum tubes each comprising:
 a top end; and 
 a bottom end; 
   one or more penetrable seals, each positioned to seal the top end of one of the one or more vacuum tubes; and   a base arranged to be reversibly attached to the bottom end of the housing and further arranged so that the bottom end of each of the one or more vacuum tubes can be at least partially positioned in the base.   
     
     
         2 . The assembly of  claim 1 , wherein:
 the assembly further comprises a vacuum tube holder positioned within the base and arranged to reversibly engage the one or more vacuum tubes;   the bottom end of the housing includes a threaded portion; and   the base includes a threaded portion arranged to reversibly engage the threaded portion of the bottom end of the housing to reversibly attach the base to the housing.   
     
     
         3 . The assembly of  claim 1 , further comprising one or more penetrable sleeves, each covering one of the one or more hollow needles. 
     
     
         4 . The assembly of  claim 1 , further comprising a filter arranged to be positioned in an interior of the collection cup. 
     
     
         5 . The assembly of  claim 1 , wherein the one or more hollow needles are integrally formed with the collection cup. 
     
     
         6 . The assembly of  claim 1 , wherein each of the one or more hollow needles is arranged to be reversibly attached to the bottom end of the collection cup to align with one of the one or more openings in the bottom end of the collection cup. 
     
     
         7 . The assembly of  claim 6 , wherein the one or more hollow needles are reversibly attached to the bottom end of the collection cup using a luer lock mechanism. 
     
     
         8 . The assembly of  claim 1 , wherein:
 the assembly further comprises a cap; and   the collection cup further comprises a threaded section positioned at the top end of the collection cup to facilitate attachment of the cap to the top end of the collection cup.   
     
     
         9 . The assembly of  claim 2 , wherein when the vacuum tube holder engages the one or more vacuum tubes, as the threaded portion of the base engages the threaded portion of the bottom end of the housing to reversibly attach the base to the housing, the one or more vacuum tubes are moved upward relative to the housing and further into the interior of the housing. 
     
     
         10 . The assembly of  claim 9 , wherein as the one or more vacuum tubes are moved upward into the interior of the housing, one of the one or more hollow needles penetrate one of the penetrable seals positioned to seal the top end of one of the one or more vacuum tubes and forms one or more passageways from the collection cup to the one or more vacuum tubes. 
     
     
         11 . The assembly of  claim 10 , as the threaded portion of the base disengages the threaded portion of the bottom end of the housing to detach the base from the housing:
 the one or more vacuum tubes are moved downward relative to the housing;   the one or more hollow needles are removed from the one or more penetrable seals; and   the one or more penetrable seals reseal the top ends of the one or more vacuum tubes.   
     
     
         12 . The assembly of  claim 10 , wherein:
 the one or more openings in the bottom end of the collection cup comprises a first opening;   the one or more hollow needles tubes comprises a first hollow needle;   the one or more vacuum tubes comprise a first vacuum tube;   the one or more penetrable seals comprises a first penetrable seal; and   the one or more passageways comprises a first passageway.   
     
     
         13 . The assembly of  claim 12 , wherein:
 the threaded portion of the bottom end of the housing is positioned on an interior surface of the bottom end of the housing;   the base further comprises:   a pedestal; and   a stem extending from the pedestal, where the threaded portion of the base is positioned on an outside surface of the stem.   
     
     
         14 . The assembly of  claim 13 , wherein a cylindrical interior surface of the stem forms the vacuum tube holder. 
     
     
         15 . The assembly of  claim 14 , wherein the vacuum tube holder engages the first vacuum tube such that when the first vacuum tube is moved upward into the interior of the housing, the alignment of the first vacuum tube is maintained such that the first hollow needle penetrates the first penetrable seal and forms the first passageway from the collection cup to the first vacuum tube. 
     
     
         16 . The assembly of  claim 10 , wherein:
 the one or more openings in the bottom end of the collection cup comprises a first opening and a second opening;   the one or more hollow needles comprises a first hollow needle and a second hollow needle;   the one or more vacuum tubes comprise a first vacuum tube and a second vacuum tube; and   the one or more penetrable seals comprises a first penetrable seal and a second penetrable seal.   
     
     
         17 . The assembly of  claim 16 , wherein:
 the threaded portion of the bottom end of the housing is positioned on an interior surface of the bottom end of the housing;   the base further comprises:
 a pedestal; and 
 a stem extending from the pedestal, where the threaded portion of the base is positioned on an outside surface of the stem. 
   
     
     
         18 . The assembly of  claim 17 , wherein the vacuum tube holder is positioned in an interior of the stem of the base and comprises a generally cylindrical body with a first recess arranged to reversibly engage the first vacuum tube and a second recess arranged to reversibly engage the second vacuum tube. 
     
     
         19 . The assembly of  claim 18 , wherein the assembly further comprises:
 a first vacuum tube guide extending from the bottom end of the collection cup and into the interior of the housing; and   a second vacuum tube guide extending from the bottom end of the collection cup and into the interior of the housing.   
     
     
         20 . The assembly of  claim 19 , wherein when the first vacuum tube and second vacuum tube are moved upward into the interior of the housing:
 the first recess of the vacuum tube holder and the first vacuum guide engage the first vacuum tube such that the alignment of the first vacuum tube is maintained such that the first hollow needle penetrates the first penetrable seal and forms the first passageway from the collection cup to the first vacuum tube; and   the second recess of the vacuum tube holder and the second vacuum guide engage the second vacuum tube such that the alignment of the second vacuum tube is maintained such that the second hollow needle penetrates the second penetrable seal and forms the second passageway from the collection cup to the second vacuum tube.