Multi-stage oral-fluid testing device

• US 10,035,146 B2
• Filed: 05/27/2014
• Issued: 07/31/2018
• Est. Priority Date: 05/24/2013
• Status: Active Grant

• Current Assignee: Premier Biotech LLC
• Original Assignee: Premier Biotech, Inc.
• Inventors: Fuller, Kevin S., Altendorf, Wayde J., Bailey, Todd
• Primary Examiner(s): Soderquist, Arlen
• Application Number:
  US14/893,461
• Publication Number:
  US 20160121322A1
• Time in Patent Office: 1,526 Days
• Field of Search: 422408, 422413, 422417, 422419-420, 422430, 436 94, 436164, 436169
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 2010/0006 involving a colour change
• CPC Class Codes: A61B 2010/0009 Testing for drug or alcohol abuse
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/046 Function or devices integrated in the closure
• CPC Class Codes: B01L 2300/047 Additional chamber, reservoir
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: G01N 33/487 of liquid biological material

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

1. A multi-stage, oral-fluid collection and testing device for collecting and testing an oral-fluid for substances, the testing device comprising:

a body assembly and a cap assembly, the body assembly comprising;

a collection sponge for absorbing an oral fluid received from a donor, a test strip for receiving the oral fluid and presenting a visual indicator indicating presence of a predetermined substance,

a body portion securing the collection sponge and the test strip and defining a fluid reservoir and a test strip channel, the test strip located in the test strip channel, the body portion further defining a vent channel;

the cap assembly, including;

a cap having a first closed end and a second open end, and configured to receive a portion of the body assembly, the cap defining a cap cavity;

a fluid container having a sealing membrane and containing a fluid for mixing with the oral fluid, the fluid container housed within the cap cavity, and

a plunger having a penetrating tip and defining a fluid channel, the plunger axially slidable within the cap, the penetrating tip of the plunger initially positioned at the sealing membrane;

wherein when cap assembly receives a cap-engagement portion of the body assembly in a first engagement position, the plunger slides towards the fluid container, causing the penetrating tip to pierce the sealing membrane thereby causing a first-stage fluid flow.

2. The testing device of claim 1, wherein receiving the cap-engagement portion during the first fluid flow does not cause the collection sponge to be compressed.

3. The testing device of claim 1, wherein the cap assembly is further configured to compress the collection sponge such that an oral-fluid mixture comprising the oral fluid and the fluid for mixing flows from the sponge to the fluid reservoir, thereby causing a second-stage fluid flow.

4. The testing device of claim 3, wherein the second stage fluid flow further comprises the oral-fluid mixture contacting the test strip and flowing through the test channel toward a distal end of the body portion and away from the cap assembly.

5. The testing device of claim 1, wherein the testing device further comprises a second test strip and defines a second test strip channel.

6. The testing device of claim 1, wherein the plunger includes a plunger extension portion and the cap-engagement portion defines a plunger-guide channel for receiving the plunger extension portion.

7. The testing device of claim 6, wherein the plunger extension portion end the plunger-guide channel are not aligned in the initial engagement position.

8. The testing device of claim 1, wherein the cap includes an alignment member projecting radially inward from an inside surface of the cap, and the cap-engagement portion includes a cap-guide channel.

9. The testing device of claim 1, wherein the cap includes a visual alignment indicator and the body includes a visual alignment indicator.

10. The testing device of claim 9, wherein the cap visual alignment indicator comprises a ridge on an outer surface of the cap, and the body visual alignment indicator comprises a groove to be aligned with die ridge prior to the initial engagement position.

11. A multi-stage, oral-fluid collection and testing device for collecting and testing an oral-fluid for substances, the testing device comprising:

a body assembly and a cap assembly, the body assembly comprising;

a collection sponge for absorbing an oral fluid received from a donor, a test strip for receiving the oral fluid and presenting a visual indicator indicating presence of a predetermined substance,

a body portion securing the collection sponge and the test strip and defining a fluid reservoir and a test strip channel, the test strip located in the test strip channel; and

a vent sponge housed in a distal end of the body portion and adapted to allow exhausted air to pass;

the cap assembly, including;

a cap having a first closed end and a second open end, and configured to receive a portion of the body assembly, the cap defining a cap cavity;

a fluid container having a sealing membrane and containing a fluid for mixing with the oral fluid, the fluid container housed within the cap cavity, and

a plunger having a penetrating tip and defining a fluid channel, the plunger axially slidable within the cap, the penetrating tip of the plunger initially positioned at the sealing membrane;

wherein when cap assembly receives a cap-engagement portion of the body assembly in a first engagement position, the plunger slides towards the fluid container, causing the penetrating tip to pierce the sealing membrane thereby causing a first-stage fluid flow.

12. A method of testing an oral fluid for a substance, the method comprising:

receiving an oral fluid in a collection sponge of a testing device, the testing device including a cap assembly and a body assembly,

the cap assembly including a fluid container having fluid and a plunger slidably connected to a cap of the cap assembly;

axially aligning the cap assembly with the body assembly;

moving the cap assembly axially to a first engagement position to receive a cap-engagement portion of the body assembly, thereby causing the plunger to slide axially within the cap to pierce a membrane of the fluid container and causing fluid to flow from the fluid container through the plunger and to the collection sponge;

moving the cap assembly further axially to a second engagement position, thereby causing the collection sponge to be compressed and causing a mixture of the fluid and the oral fluid to flow into a fluid reservoir of the body assembly; and

exhausting air through a vent channel in a distal portion of the body.

13. The method of claim 12, further comprising displaying a visual indication of the presence of the oral fluid and fluid from the fluid container.

14. The method of claim 13, further comprising viewing the visual indication through a viewing window.

15. A method of testing an oral fluid for a substance, the method comprising:

receiving an oral fluid at a collection sponge of a testing device, the testing device including a cap assembly and a body assembly, the sponge attached to a body portion of the body assembly and defining an end of the body assembly;

engaging the cap assembly with the body portion with the sponge therebetween;

moving axially the cap to release a buffer solution that travels to the sponge before compressing the sponge;

compressing the sponge with the buffer solution and saliva into a restricted region with a saliva pathway outlet that leads to a test strip; and

exhausting air through a vent channel in a distal portion of the body.

16. The method of claim 15 further comprising axially moving the cap assembly further to a seating position.

17. The method of claim 15 further comprising axially moving the cap assembly further to a locked position whereby the cap cannot be removed without fracturing or damaging the testing device.

18. The method of claim 15 further comprising axially moving the cap assembly further to a locked position whereby the cap cannot be removed without fracturing or damaging the testing device unless tools are utilized to open same.