Devices and methods for collecting and analyzing fluid samples from the oral cavity

#The present invention relates to devices and methods suitable for in-home use to collect fluid samples from the oral cavity for analysis.

#In addition to regular professional dental checkups, daily oral hygiene is generally recognized as an effective preventative measure against the onset, development, and/or exacerbation of periodontal disease, gingivitis and/or tooth decay. Unfortunately, however, even the most meticulous individuals dedicated to thorough brushing and flossing practices often fail to reach, loosen and remove deep-gum and/or deep inter-dental food particulate, plaque or biofilm. Most individuals have professional dental cleanings biannually to remove tarter deposits.

#For many years products have been devised to facilitate the simple home cleaning of teeth, although as yet a single device which is simple to use and cleans all surfaces of a tooth and/or the gingival or sub-gingival areas simultaneously is not available. The conventional toothbrush is widely utilized, although it requires a significant input of energy to be effective and, furthermore, a conventional toothbrush cannot adequately clean the inter-proximal areas of the teeth. Cleaning of the areas between teeth currently requires the use of floss, pick, or some such other additional device apart from a toothbrush.

#FIG. 1 is a schematic drawing of one embodiment of an apparatus that may be utilized in the present invention;

#FIG. 2 is a schematic drawing of an alternative embodiment of an apparatus that may be utilized in the present invention;

#FIG. 3 is a schematic drawing of another alternative embodiment of an apparatus that may be utilized in the present invention;

#The present invention is directed to devices suitable for collecting samples of a fluid from the oral cavity of a mammal. The device includes a mouthpiece comprising a chamber for fitting around the teeth of the user and means for collecting the fluid sample from the oral cavity. In certain embodiments, the mouthpiece is suitable for directing a liquid onto a plurality of surfaces of the oral cavity. In such embodiments, the chamber maintains the liquid proximate the plurality of surfaces of the oral cavity and the front and rear inner walls include a plurality of openings. The mouthpiece includes a first manifold for containing a first portion of the liquid and providing the first portion to the chamber through the openings of the front inner wall, a second manifold for containing a second portion of the liquid and providing the second portion to the chamber through the openings of the rear inner wall, a first port for conveying the first portion of liquid to and from the first manifold, a second port for conveying the second portion of liquid to and from the second manifold. The mouthpiece further includes means for providing an effective seal of the mouthpiece within the oral cavity. The invention is further directed to methods of collecting and analyzing samples of fluid from the oral cavity, including the steps of placing the device in the oral cavity, collecting the fluid samples and conducting an analysis of the fluid samples.

#The terms “reciprocating movement of liquid(s)” and “reciprocation of liquid(s)” are used interchangeably herein. As used herein, both terms mean alternating the direction of flow of the liquid(s) back and forth over surfaces of the oral cavity of a mammal from a first flow direction to a second flow direction that is opposite the first flow direction.

#By “effective fit or seal”, it is meant that the level of sealing between the means for directing liquid onto and about the plurality of surfaces in the oral cavity, e.g. an application tray, is such that the amount of leakage of liquid from the tray into the oral cavity during use is sufficiently low so as to reduce or minimize the amount of liquid used and to maintain comfort of the user, e.g. to avoid choking or gagging. Without intending to be limited, gagging is understood to be a reflex (i.e. not an intentional movement) muscular contraction of the back of the throat caused by stimulation of the back of the soft palate, the pharyngeal wall, the tonsillar area or base of tongue, meant to be a protective movement that prevents foreign objects from entering the pharynx and into the airway. There is variability in the gag reflex among individuals, e.g. what areas of the mouth stimulate it. In addition to the physical causes of gagging, there may be a psychological element to gagging, e.g. people who have a fear of choking may easily gag when something is placed in the mouth.