US 12,214,345 B2
Multi-stage oral-fluid testing device with cap containing plunger for oral-fluid release from collection sponge
Kevin S. Fuller, Chaska, MN (US); Wayde J. Altendorf, Hickson, ND (US); and Todd Bailey, Shorewood, MN (US)
Assigned to Premier Biotech, LLC, Minneapolis, MN (US)
Filed by Premier Biotech, LLC, Minneapolis, MN (US)
Filed on Aug. 16, 2021, as Appl. No. 17/403,013.
Application 17/403,013 is a continuation of application No. 16/050,921, filed on Jul. 31, 2018, granted, now 11,090,648.
Application 16/050,921 is a continuation of application No. 14/893,461, granted, now 10,035,146, previously published as PCT/US2014/039607, filed on May 27, 2014.
Claims priority of provisional application 61/827,328, filed on May 24, 2013.
Prior Publication US 2022/0023858 A1, Jan. 27, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/487 (2006.01); A61B 10/00 (2006.01); B01L 3/00 (2006.01)
CPC B01L 3/5023 (2013.01) [A61B 10/0051 (2013.01); B01L 3/5029 (2013.01); G01N 33/487 (2013.01); A61B 2010/0006 (2013.01); A61B 2010/0009 (2013.01); B01L 2200/025 (2013.01); B01L 2200/0684 (2013.01); B01L 2200/10 (2013.01); B01L 2300/042 (2013.01); B01L 2300/046 (2013.01); B01L 2300/047 (2013.01); B01L 2300/0663 (2013.01); B01L 2300/069 (2013.01); B01L 2300/0825 (2013.01); B01L 2300/0864 (2013.01); B01L 2400/0406 (2013.01); B01L 2400/0478 (2013.01)] 23 Claims
OG exemplary drawing
 
1. A testing device for collecting and testing a bodily fluid for a substance, the testing device comprising:
a body assembly including a collection sponge;
a cap assembly, including:
a cap having a first end and a second end opposite the first end, and configured to receive a portion of a body assembly at the second end when the portion of body assembly is inserted into the cap, the cap defining a first cap cavity at the first end and a second cap cavity at the second end;
a fluid container disposed in the first cap cavity, wherein the fluid container includes a sealing membrane and contains a mixing fluid for mixing with a bodily fluid; and
a plunger with an end wall, the plunger being movably disposed in the second cap cavity, wherein the body assembly and the cap assembly are configured to interact such that relative axial movement of the cap from an earlier engagement position to a later engagement position will cause compression of the collection sponge by the end wall of the plunger.
 
20. A multi-stage, bodily-fluid collection and testing device for collecting and testing a bodily fluid for a substance, the testing device comprising:
a body assembly, including:
a body portion including a fluid flow path extending from a collection sponge cavity to a test strips channel;
a collection sponge attached to the body portion in the collection sponge cavity for absorbing a bodily fluid from a donor; and
one or more test strips for receiving the bodily fluid and presenting a visual indicator indicating the presence of a predetermined substance; and
a cap assembly, including:
a cap having a first closed end and a second open end, and configured to receive a portion of the body portion when the portion of the body assembly is inserted into the cap, the cap defining a cap cavity;
a fluid container having a sealing membrane and containing a mixing fluid for mixing with the bodily fluid, the fluid container being housed within the cap cavity; and
a plunger movably disposed in the cap cavity, wherein the plunger includes a piercing end, wherein the plunger is able to be moved from a first position to a second position, and wherein at the first position the piercing end is spaced apart from the sealing membrane, and at the second position the piercing end penetrates the sealing membrane, wherein the plunger is also configured to engage and compress the collection sponge.