Saliva collection device

• US 9,113,850 B2
• Filed: 08/22/2011
• Issued: 08/25/2015
• Est. Priority Date: 08/20/2010
• Status: Active Grant

• Current Assignee: Reflex Medical Corp.
• Original Assignee: Reflex Medical Corp.
• Inventors: Skakoon, James G.
• Primary Examiner(s): Henson, Devin
• Assistant Examiner(s): McCrosky, David J
• Application Number:
  US13/214,722
• Publication Number:
  US 20120046574A1
• Time in Patent Office: 1,464 Days
• Field of Search: 422/562, 425/8, 600/573
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30

Abstract

A device for collecting oral fluid includes a mouthpiece with a fluid inlet connected to a collection chamber. The collection chamber includes a collecting vessel, a venting outlet, and an access port. The venting outlet may be covered by a liquid-impervious or resistant membrane, such as a hydrophobic membrane, and the access port is suitable for removing some or all of the collected fluid. This arrangement allows a saliva donor to continuously spit saliva and blow air into the closed collection chamber, without pressure build-up in the collection chamber, and without the need for the donor to release from the device until the desired oral fluid volume is collected. A valve, including a check valve may be in the saliva flow stream and baffles and structure creating a tortuous path may be utilized to keep saliva away from the membrane.

Claims

1. A device for collecting oral fluid comprising:

an upper header assembly and a collection vessel removably attachable to the upper header assembly, the collection vessel defining a vertical axis extending through the upper header assembly when attached to the upper header assembly, the upper header assembly comprising;

a header housing defining a header chamber therein, the housing comprising an upwardly oriented vent face portion having at least one vent opening with a hydrophobic filter adjacent thereto;

the header housing including a converging portion defining a converging portion of the header chamber, the converging portion of the header housing extending to a lower receptacle portion defining a header chamber lower outlet where the collection vessel attaches, the header housing having a side inlet connecting to a mouthpiece extending laterally from the header housing, the upwardly oriented vent face portion positioned above the side inlet, the mouthpiece shaped to be received by a mouth and having a saliva inlet connecting to the header chamber by way of a passageway, the header housing having an upright wall opposite the side inlet;

the collection vessel removably engaged with the lower receptacle portion whereby saliva received in the header chamber can flow by gravity into the collection vessel and the filter is positioned above the side inlet.

2. The device of claim 1 wherein the upwardly oriented vent face portion is generally planar and defines an upper chamber wall traversed by the hydrophobic filter.

3. The device of claim 1 wherein the filter comprises polytetrafluoroethylene.

4. The device of claim 1 wherein the mouthpiece includes a shaft extending from the housing and a mouth guard extending from the shaft, the saliva passageway extending through the shaft.

5. The device of claim 1 further comprising a valve positioned in the device along the saliva passageway and captured by the mouthpiece.

6. The device of claim 5 wherein the valve is a one way valve to allow saliva to pass into the header chamber from the saliva inlet but not from the header chamber to the inlet.

7. The device of claim 1 further comprising an access means for the collection vessel, the access means comprising one of the set of:

a removable plug, a Luer connector and Luer plug, a needle-free access port, a pierceable area, a peelable strip, a frangible tab, and a separable portion of the collection vessel.

8. The device of claim 1 wherein the vessel is a configured as a transparent vial and has gradations thereon and threadingly attaches to the lower receptacle portion.

9. A device for collecting oral fluid comprising:

an upper header assembly and a collection vessel removably attached to the upper header assembly, the upper header assembly comprising;

a header housing defining a header chamber therein, the housing comprising an upwardly oriented vent face portion having at least one vent opening with a hydrophobic filter adjacent thereto;

a converging portion extending from the vent face, the converging portion defining a converging portion of the chamber, the converging portion extending to a lower receptacle portion defining a header chamber lower outlet, a mouthpiece extending from the header housing, the mouthpiece shaped to be received by a mouth and having a saliva inlet connecting to the header chamber by way of a passageway;

the collection vessel removably engaged with the lower receptacle portion whereby saliva in the header chamber can flow by gravity into the collection vessel;

wherein the device has a vertical axis and the area of the hydrophobic filter is greater than the area of a cross-section of the header portion chamber taken at a plane perpendicular to the axis of the device.

10. A device for collecting oral fluid comprising:

an upper header assembly and a collection vessel removably attached to the upper header assembly, the upper header assembly comprising;

a header housing defining a header chamber therein, the housing comprising an upwardly oriented vent face portion having at least one vent opening with a hydrophobic filter adjacent thereto;

a converging portion extending from the vent face, the converging portion defining a converging portion of the chamber, the converging portion extending to a lower receptacle portion defining a header chamber lower outlet, a mouthpiece extending from the header housing, the mouthpiece shaped to be received by a mouth and having a saliva inlet connecting to the header chamber by way of a passageway;

the collection vessel removably engaged with the lower receptacle portion whereby saliva in the header chamber can flow by gravity into the collection vessel;

wherein the device has a vertical axis and the vent face and the hydrophobic filter are arranged at an oblique angle from horizontal.

11. A device for collecting oral fluid comprising:

an upper header assembly and a collection vessel removably attached to the upper header assembly, the collection vessel having a vertical axis, the upper header assembly comprising;

a header housing defining a header chamber therein, the housing having at least one vent opening extending from the header chamber to exterior the device, the header housing comprising a lower receptacle portion defining a header chamber lower outlet for connection to the collection vessel, the header housing having a side inlet with a mouthpiece extending horizontally therefrom, the mouthpiece shaped to be received by a mouth and having a saliva inlet connecting to the header chamber by way of a saliva passageway, the saliva passageway extending straight and horizontally from the saliva inlet into the header chamber;

a check valve positioned in the device at the saliva passageway;

the collection vessel removably engaged with the lower receptacle portion, wherein the valve is a one way valve to allow saliva to pass into the header chamber from the saliva inlet but not from the header chamber to the inlet and the valve is captured by the mouthpiece at the header inlet.

12. The device of claim 11 wherein the valve is a duckbill valve.

13. A device for collecting oral fluid comprising:

an upper header assembly and a collection vessel removably attached to the upper header assembly, the collection vessel having a vertical axis, the upper header assembly comprising;

a header housing defining a header chamber therein, the housing having at least one vent opening extending from the header chamber to exterior the device, the header housing comprising a lower receptacle portion defining a header chamber lower outlet for connection to the collection vessel, the header housing having a side inlet with a mouthpiece extending horizontally therefrom, the mouthpiece shaped to be received by a mouth and having a saliva inlet connecting to the header chamber by way of a saliva passageway, the saliva passageway extending straight and horizontally from the saliva inlet into the header chamber;

a check valve positioned in the device at the saliva passageway;

the collection vessel removably engaged with the lower receptacle portion, wherein the housing comprises an upwardly oriented vent face portion and the vent is positioned thereat, the vent face portion being generally planar and part of an upper chamber wall traversed by a hydrophobic filter.

14. A device for collecting oral fluid comprising:

an upper header assembly and a collection vessel removably attached to the upper header assembly, the upper header assembly comprising;

a header housing defining a header chamber therein, the housing having at least one vent opening extending from the header chamber to exterior the device, the header housing comprising a lower receptacle portion defining a header chamber lower outlet, a mouthpiece extending from the header housing, the mouthpiece shaped to be received by a mouth and having a saliva inlet connecting to the header chamber by way of a saliva passageway;

a valve positioned in the device at the saliva passageway;

the collection vessel removably engaged with the lower receptacle portion;

wherein the device has a vertical axis and a hydrophobic filter configured as a layer at the vent, the area of the hydrophobic filter is greater than an area of a cross-section of the header portion chamber taken at a plane perpendicular to the axis of the device.

15. The device of claim 14 wherein the filter comprises polytetrafluoroethylene.

16. A device for collecting oral fluid comprising:

an upper header assembly and a collection vessel removably attached to the upper header assembly, the collection vessel having a vertical axis, the upper header assembly comprising;

a header housing defining a header chamber therein, the housing having at least one vent opening extending from the header chamber to exterior the device, the header housing comprising a lower receptacle portion defining a header chamber lower outlet for connection to the collection vessel, the header housing having a side inlet with a mouthpiece extending horizontally therefrom, the mouthpiece shaped to be received by a mouth and having a saliva inlet connecting to the header chamber by way of a saliva passageway, the saliva passageway extending straight and horizontally from the saliva inlet into the header chamber;

a check valve positioned in the device at the saliva passageway;

the collection vessel removably engaged with the lower receptacle portion, wherein the vent has a hydrophobic filter adjacent thereto and the hydrophobic filter has an dimensional area exposed to the interior of the header chamber and the vessel has a horizontal cross sectional area and the area exposed to the interior of the header chamber is at least twice the horizontal cross sectional area of the vessel.

17. The device of claim 16 wherein the hydrophobic filter has an area exposed to the interior of the header chamber and the header chamber has a maximum horizontal cross sectional area and the area exposed to the interior of the header chamber is equal to or greater that the maximum horizontal cross sectional area of the header chamber.

18. The device of claim 16 wherein the hydrophobic filter has an area exposed to the interior of the header chamber and the header chamber has a maximum horizontal cross sectional area and the area exposed to the interior of the header chamber is at least half of the horizontal cross sectional area of the vessel.

19. A device for collecting oral fluid comprising:

an upper header assembly and a collection vessel removably attached to the upper header assembly, the collection vessel having a vertical axis, the upper header assembly comprising;

a header housing defining a header chamber therein, the housing having at least one vent opening extending from the header chamber to exterior the device, the header housing comprising a lower receptacle portion defining a header chamber lower outlet for connection to the collection vessel, the header housing having a side inlet with a mouthpiece extending horizontally therefrom, the mouthpiece shaped to be received by a mouth and having a saliva inlet connecting to the header chamber by way of a saliva passageway, the saliva passageway extending straight and horizontally from the saliva inlet into the header chamber;

a check valve positioned in the device at the saliva passageway;

the collection vessel removably engaged with the lower receptacle portion, wherein the mouthpiece includes a shaft extending from the housing and a mouth guard extending from the shaft, the saliva passageway extending through the shaft.

20. A device for collecting oral fluid comprising:

an upper header assembly and a collection vessel removably attached to the upper header assembly, the collection vessel having a vertical axis, the upper header assembly comprising;

a header housing defining a header chamber therein, the housing having at least one vent opening extending from the header chamber to exterior the device, the header housing comprising a lower receptacle portion defining a header chamber lower outlet for connection to the collection vessel, the header housing having a side inlet with a mouthpiece extending horizontally therefrom, the mouthpiece shaped to be received by a mouth and having a saliva inlet connecting to the header chamber by way of a saliva passageway, the saliva passageway extending straight and horizontally from the saliva inlet into the header chamber;

a check valve positioned in the device at the saliva passageway;

the collection vessel removably engaged with the lower receptacle portion, the device further comprising an access means for the collection vessel, the access means comprising one of the set of;

a removable plug, a Luer connector and Luer plug, a needle-free access port, a pierceable area, a peelable strip, a frangible tab, and a separable portion of the collection vessel.

21. The device of claim 20 wherein the mouthpiece includes a mouthguard, said mouthguard providing a stop at a proper insertion depth in the mouth.

22. The device of claim 20 wherein said access means further comprises a tamper-evident means.

23. A device for collecting oral fluid comprising:

an upper header assembly and a collection vessel removably attached to the upper header assembly, the collection vessel having a vertical axis, the upper header assembly comprising;

a header housing defining a header chamber therein, the housing having at least one vent opening extending from the header chamber to exterior the device, the header housing comprising a lower receptacle portion defining a header chamber lower outlet for connection to the collection vessel, the header housing having a side inlet with a mouthpiece extending horizontally therefrom, the mouthpiece shaped to be received by a mouth and having a saliva inlet connecting to the header chamber by way of a saliva passageway, the saliva passageway extending straight and horizontally from the saliva inlet into the header chamber;

a check valve positioned in the device at the saliva passageway;

the collection vessel removably engaged with the lower receptacle portion, the device further comprising at least one of the following;

preservatives, anti-foaming agents, and chemical test reagents.