US2022338847A1PendingUtilityA1

Oral fluid collection device

63
Assignee: ORASURE TECH INCPriority: Apr 26, 2021Filed: Mar 31, 2022Published: Oct 27, 2022
Est. expiryApr 26, 2041(~14.8 yrs left)· nominal 20-yr term from priority
A61B 2010/009A61B 10/0051
63
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Claims

Abstract

An oral fluid collection device includes a plunger and funnel to simultaneously collect and split a single specimen into metered doses for drug testing. The device may be used with collection tubes for collection of the metered doses and later testing. The device, when used, drives the metered dose into the collection tubes and removes bubbles in the specimen to provide improved accuracy in testing.

Claims

exact text as granted — not AI-modified
The claimed invention is: 
     
         1 . An oral fluid collection device for drug testing, comprising:
 a funnel for collecting a specimen of oral fluids and simultaneously split the specimen into two or more metered doses, the funnel comprising:
 a valve that allows the specimen to exit the funnel when a plunger is driven into the funnel; and 
   the plunger that at least partially nests in the funnel to drive the specimen out of the funnel through the valve in the two or more metered doses.   
     
     
         2 . The device of  claim 1 , wherein the funnel includes two or more legs for collecting the two or more metered doses in a single specimen. 
     
     
         3 . The device of  claim 1 , wherein the funnel includes a translucent or transparent material to allow a user to verify a volume of the specimen that has been collected in the funnel. 
     
     
         4 . The device of  claim 1 , wherein the funnel includes a fill indicator to verify a volume of the specimen has met a minimum and/or maximum volume. 
     
     
         5 . The device of  claim 4 , wherein the fill indicator accounts for foaming of the specimen when collected. 
     
     
         6 . The device of  claim 1 , wherein the plunger further comprises:
 an overflow channel for overflow of the specimen and air to escape from the funnel when driven by the plunger.   
     
     
         7 . The device of  claim 6 , wherein the plunger further comprises:
 a cover to prevent the overflow of the specimen from escaping the plunger and to allow air to escape.   
     
     
         8 . The device of  claim 1 , wherein the valve is overmolded to the funnel. 
     
     
         9 . The device of  claim 1 , wherein the plunger further comprises:
 a hard stop for metering the two or more metered doses.   
     
     
         10 . An oral fluid collection assembly for drug testing, comprising:
 a funnel for collecting a specimen of oral fluids and simultaneously split the specimen into two or more metered doses, the funnel comprising:
 a valve that allows the specimen to exit the funnel when a plunger is driven into the funnel; 
   the plunger that at least partially nests in the funnel to drive the specimen out of the funnel through the valve in the two or more metered doses; and   two or more tubes to collect each of the two or more metered doses from the funnel.   
     
     
         11 . The device of  claim 10 , wherein the funnel includes two or more legs for collecting the two or more metered doses in a single specimen. 
     
     
         12 . The device of  claim 10 , wherein the funnel includes a translucent or transparent material to allow a user to verify a volume of the specimen that has been collected in the funnel. 
     
     
         13 . The device of  claim 10 , wherein the funnel includes a fill indicator to verify a volume of the specimen has met as minimum and/or maximum volume. 
     
     
         14 . The device of  claim 13 , wherein the fill indicator accounts for foaming of the specimen when collected. 
     
     
         15 . The device of  claim 10 , wherein the plunger further comprises:
 an overflow channel for overflow of the specimen and air to escape from the funnel when driven by the plunger.   
     
     
         16 . The device of  claim 15 , wherein the plunger further comprises:
 a cover to prevent the overflow of the specimen from escaping the plunger and to allow air to escape.   
     
     
         17 . The device of  claim 10 , wherein the valve is overmolded to the funnel. 
     
     
         18 . The device of  claim 10 , wherein the plunger further comprises:
 a hard stop for metering the two or more metered doses.   
     
     
         19 . The method of collecting a specimen of an oral fluid for drug testing, the method comprising:
 collecting the specimen in a funnel to simultaneously split the specimen into two or more metered doses;   driving the specimen from the funnel with a plunger; and   collecting, via a valve of the funnel, each of the two or more metered doses in a testing tube.   
     
     
         20 . The method of  claim 19 , further comprising:
 adding a buffer solution or preservative to the testing tube; and   mixing the buffer solution or preservative and each of the two or more metered doses in the testing tube.   
     
     
         21 . The method of  claim 19 , wherein each of the two or more metered doses is at least about one milliliter (mL). 
     
     
         22 . The method of  claim 20 , wherein a volume of the mixed buffer solution or preservative is around two mL.

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