# US 12,214,345 B2 · Multi-stage oral-fluid testing device with cap containing plunger for oral-fluid release from collection sponge > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,214,345 B2 - Document ID: US12214345B2 - Status: Granted - Kind: B2 - Application number: 17/403,013 - Filed: 2021-08-16 - Published: 2022-01-27 - Granted: 2025-02-04 - Earliest claimed: 2013-05-24 - Assignees: Premier Biotech, Inc. - Applicants: Premier Biotech, LLC - Inventors: Kevin S. Fuller; Wayde J. Altendorf; Todd Bailey - Web page: https://patentgrep.com/patent/US12214345B2 ## CPC - B01L 3/5023: {with a sample being transported to, and subsequently stored in an absorbent for analysis} - A61B 10/0051: {for taking saliva or sputum samples (devices for receiving spittle A61J9/00)} - B01L 3/5029: {using swabs} - G01N 33/487: of liquid biological material - A61B 2010/0006: {involving a colour change} - A61B 2010/0009: {Testing for drug or alcohol abuse} - B01L 2200/025: Align devices or objects to ensure defined positions relative to each other - B01L 2200/0684: Venting, avoiding backpressure, avoid gas bubbles - B01L 2200/10: Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept - B01L 2300/042: Caps; Plugs - B01L 2300/046: Function or devices integrated in the closure - B01L 2300/047: Additional chamber, reservoir - B01L 2300/0663: Whole sensors - B01L 2300/069: Absorbents; Gels to retain a fluid - B01L 2300/0825: Test strips - B01L 2300/0864: comprising only one inlet and multiple receiving wells, e.g. for separation, splitting - B01L 2400/0406: capillary forces - B01L 2400/0478: pistons - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract In an embodiment, the claimed invention includes an oral-fluid collection and testing device that. is simple to operate. The device includes a body assembly and a cap assembly that are easy to handle by a user. A collection sponge projects from an end of the body assembly for absorbing the oral fluid of a donor, A cap assembly is easily aligned with the body assembly by way of visual alignment indicators on both the body and the cap. Once the cap is aligned with the body, a user simply pushes the cap onto the ‘body, which causes a first stage fluid, flow. More specifically, a buffer fluid is released from the cap and mixes with the oral fluid collected on the sponge—After waiting a short time* the cap is rotated, then pushed again, causing a second-stage fluid flow in which the sponge is compressed such that the buffer fluid/oral fluid exits the sponge and flows toward a. pair of test strips. A user can then easily view the test results by observing a visual indication, such as a color change of the test strips through a viewing window. ## Claims ### Claim 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. ### Claim 2 (depends on 1) The testing device of claim 1, wherein the plunger comprises a body portion extending from the end wall, the body portion having a tip, wherein the tip is spaced apart from the sealing membrane when the cap assembly is separated from the body assembly prior to use. ### Claim 3 (depends on 2) The testing device of claim 2, wherein the tip penetrates the sealing membrane of the fluid container when the plunger is in the earlier engagement position. ### Claim 4 (depends on 1) The testing device of claim 1, wherein the body assembly comprises a test strips channel configured to receive a mixture of the bodily fluid and the mixing fluid. ### Claim 5 (depends on 4) The testing device of claim 4, wherein the body assembly further comprises one or more test strips disposed in the test strips channel. ### Claim 6 (depends on 5) The testing device of claim 5, wherein the collection sponge is in fluid communication with the one or more test strips. ### Claim 7 (depends on 1) The testing device of claim 1, wherein when the cap receives a cap engagement portion of the body assembly. ### Claim 8 (depends on 1) The testing device of claim 1, wherein the body assembly and the cap assembly are configured such that the cap will be in a first angular orientation in the earlier engagement position and a second angular orientation in the later engagement position. ### Claim 9 (depends on 1) The testing device of claim 1, wherein a second side of the end wall of the plunger facing the second end of the cap will contact the compression sponge in the earlier engagement position with a first side of the end wall facing the first end of the cap. ### Claim 10 (depends on 7) The testing device of claim 7, wherein the cap engagement portion of the body assembly defines a plurality of channels configured to guide axial movement of the cap assembly. ### Claim 11 (depends on 10) The testing device of claim 10, wherein the plurality of channels includes at least one axial channel to guide an extension portion of the plunger and at least one configured channel to guide axial movement of the cap. ### Claim 12 (depends on 11) The testing device of claim 11, wherein the cap and plunger are configured such that the cap can move relative to the plunger in a rotational direction. ### Claim 13 (depends on 11) The testing device of claim 11, wherein the configured channel has a first axial channel portion, a second radial channel portion, and a third axial channel portion. ### Claim 14 (depends on 13) The testing device of claim 13, wherein the cap includes an inwardly directed alignment member operative to engage the configured channel of the cap engagement portion. ### Claim 15 (depends on 1) The testing device of claim 1, wherein the plunger further includes a plunger extension portion and a body portion of the body assembly further includes a cap-engagement portion for receiving the plunger extension portion. ### Claim 16 (depends on 15) The testing device of claim 15, wherein the body assembly and the cap assembly are configured such that the extension portion will engage a rim of the cap-engagement portion when the cap assembly is in an initial engagement position prior to the earlier engagement position. ### Claim 17 (depends on 1) The testing device of claim 1, wherein a body portion of the body assembly further includes a vent channel. ### Claim 18 (depends on 1) The testing device of claim 1, wherein the body assembly and the cap assembly are separated prior to use. ### Claim 19 (depends on 8) The testing device of claim 8, wherein the body assembly and the cap assembly are further configured such that the cap will be in a third angular orientation in an initial engagement position prior to the earlier engagement position. ### Claim 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. ### Claim 21 (depends on 20) The testing device of claim 20, wherein the plunger is configured to engage the collection sponge but the collection sponge is not compressed when the plunger is at the first position. ### Claim 22 (depends on 20) The testing device of claim 20, wherein the plunger is configured to engage the collection sponge and the plunger is at the second position when the collection sponge is compressed. ### Claim 23 (depends on 22) The testing device of claim 22, wherein the plunger is movable along with the cap relative to the body portion in order to cause compression of the collection sponge.