Saliva collection device

Inventors

Skakoon, James G.

Assignees

Reflex Medical Corp

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.

Core Innovation

The invention relates to a device for collecting oral fluid that enables saliva to flow by gravity into a collection vessel while venting air through an upwardly oriented vent face portion. The device includes an upper header assembly with a header chamber and a mouthpiece received by a mouth, where the mouthpiece has a saliva inlet connected to the header chamber by way of a passageway. The collection vessel is removably attachable to the upper header assembly, and the header housing includes a lower receptacle portion defining a header chamber lower outlet for connection to the collection vessel.

Venting is provided by at least one vent opening extending from the header chamber to exterior the device, with a hydrophobic filter positioned adjacent the vent opening and traversing an upwardly oriented vent face portion that forms part of an upper chamber wall. The hydrophobic filter is configured as a layer at the vent, and the device further defines relative or comparative hydrophobic filter area limitations. The vent face and the hydrophobic filter are arranged at an oblique angle from horizontal in one configuration.

The saliva flow path includes a valve positioned at the saliva passageway, including a one way valve or check valve positioned in the device to allow saliva to pass into the header chamber but not from the header chamber to the inlet. The valve is captured by the mouthpiece at the header inlet in one configuration. In further configurations, the mouthpiece includes a shaft and a mouth guard, and the access means for the collection vessel includes one of a removable plug, a Luer connector and Luer plug, a needle-free access port, a pierceable area, a peelable strip, a frangible tab, or a separable portion of the collection vessel.

Claims Coverage

The document provides multiple independent claims defining a gravity-fed oral fluid collection device with a removable collection vessel. Across the independent claims, the inventive features focus on the upper header assembly with venting and a hydrophobic filter, gravity flow from a header chamber to the vessel, a mouthpiece-side inlet saliva passageway, and a valve or check valve arranged to prevent backflow, with additional geometric area and angular constraints and vessel access options.

Across the independent claims, the core claim coverage centers on a gravity-fed oral fluid collection device with a removably attachable collection vessel, a vent opening with a hydrophobic filter on an upwardly oriented vent face portion, and a mouthpiece-side inlet saliva passageway. Several independent claims further define main inventive constraints using hydrophobic filter area relationships and vent and filter orientation, while the valve or check valve arrangement and mouthpiece features prevent reverse flow and structure the inlet interface.

Stated Advantages

Documented Applications