FR2752718A1 - REMOVABLE HYGIENIC MOUTHPIECE - Google Patents

Abstract

The invention concerns a removable hygienic mouthpiece of the type comprising a mouthpiece (1) capable of being adapted on an apparatus for controlling expired air and comprising an inlet connection piece (4) and an outlet connection piece (7) separated by a baffle (10, 11) and it is characterised in that the baffle (10, 11) comprises a foam with open cells and in that the mouthpiece (1) is made of materials treated against microbes. The invention is useful in particular, associated with a breathalyser, for measuring the amount of alcohol in a subject.

Description

Removable hygienic mouthpiece
The present invention relates to a hygienic mouthpiece adaptable to devices intended to carry out measurements on exhaled respiratory air, in particular breathalyzers, spirometers or other respiratory analysis or control devices.

Prior art
Certain devices intended for controlling the exhaled respiratory air such as, for example, breathalyzers, are generally used successively by different people and the problem then arises of ensuring good hygiene in order to eliminate any risk of contamination between successive users. . For this purpose, the simplest solution is to place a disposable tip that is discarded after a single use. In this case, it is important to provide a device intended to avoid a return of pollution from the measuring circuits of the device, as is for example recommended according to US 4,564,021 which offers a disposable tip provided with a check valve. -back near the inlet tubing or FR-2 577 677 which recommends a valve at the inlet of the sampling tube. We also find other descriptions of disposable tips such as for example according to FR 2 709 000 which describes a tip whose functional parts are particularly adapted to the sampling technology, but does not make any special provisions intended to limit contamination. .

 The use of disposable disposable tips assumes that the tip will actually be changed with each use and therefore requires a certain discipline. It is also necessary to have a reserve of clean tips which must be stored in good conditions and to manage the destruction of used tips.

 The use of permanent tips is possible in the case of devices used under the supervision of qualified personnel who can ensure cleaning by means of decontaminating solutions or by means of high temperature sterilization. Such constraints are not compatible with small devices of the breathalyzer type which are used on an outpatient basis, without the assistance of medical personnel.

Subject of the invention
The present invention provides a mouthpiece which ensures good hygiene of use due to its design and the materials used for its production.

Description
According to the invention, the mouthpiece comprises an inlet tubing and an outlet tubing separated by a baffle comprising an absorbent foam with open cells, the assembly being manufactured using treated antimicrobial materials.

detailed description
The mouthpiece according to the invention, adaptable to apparatuses of the ethylometer or spirometer type, is of the semi-permanent type and comprises an inlet pipe for the expired air and an outlet pipe adaptable to the device, these two tubing being separated by a baffle in which one or more elements of an open cell foam have been placed. The inlet tubing is of a suitable size and shape for the user to blow with the mouth, and may in practice take the form of a whistle mouthpiece. The outlet tube is of a size suitable for cooperating in leaktight manner with the measuring device. These two pipes are not aligned and form a baffle between them which generates turbulence in the exhaled air flow. According to the invention, the walls of this turbulence zone are covered with an open cell cellular material which has the function of retaining the particles in suspension or drops of saliva which could be entrained from the mouth by the air. respiratory exhaled. In order to ensure better hygiene for the user, the various constituent materials of the tip contain anti-microbial agents chosen to suppress any microbial proliferation: thus the tip can be used several times, without risk of microbial development.

 The accompanying drawings which complete the description allow a better appreciation of the invention.

 Figure 1 shows a perspective view of the nozzle according to the present invention.

 Figure 2 shows a longitudinal section of the nozzle according to the invention.

 FIG. 3 represents a view of the end piece in a section located in the area common to the two pipes of said end piece.

The mouthpiece (1) according to the present invention consists of a body (2) comprising
an inlet part 3 in the form of a whistle and comprising an access orifice 4 which is extended by a first tube 5, of predetermined length,
an outlet part 6 in which a second tube 7 is formed, and whose axis 8 is offset with respect to the axis 9 of the tube 5.

 Buffers 10 and 11 are placed respectively in the bottom of the tubing 5 and in the bottom of the tubing 7 and form a stop baffle for the penetration of saliva or particles into the tubing 7.

 The production of a mouthpiece according to the invention was made from a food-grade polypropylene in which 0.5% N- (trichlomethylthio) -4-cyclohexene-1,2 was added by hot mixing. - dicarboximide, (antimicrobial known under the DCI CAPTAN and marketed under the brand VANCIDE 89 by the company VANDERBILT). The pads 10 and 11 are made of synthetic foam and, according to the shape shown in FIGS. 2 and 3, have been cut from an open cell polyurethane foam containing an anti microbial agent (sold under the name Permafresh by the company ROGERS) and held by a point of glue at the bottom of each of the tubes.

 Bacteriological tests in the laboratory show that the microbial strains commonly encountered in the oral environment do not develop in the mouthpiece according to the invention. A test carried out on the polypropylene treated as indicated above and which has undergone an initial microbial seeding of 5.5 × 10 5 CFU / mm 2 Staphylococcus aureus shows after 24 hours a reduction according to a factor of 100 compared to a control of untreated polypropylene.

 Other tests carried out on the guinea pig or the hamster demonstrate for the polypropylene treated an absence of sensitization and an absence of irritation of the oral mucosa. Finally, tests on cell cultures of fibroblasts prove that this material is not cytotoxic.

 The mouthpiece produced thus has entirely favorable new qualities for ensuring correct hygiene and considerably reducing the risks of contamination linked to repeated use of the device fitted with this mouthpiece.

 This example, obtained with a rate of 0.5% of Vancide 89 in polypropylene, is not limiting and one can use any other antimicrobial agent compatible in nature and in dosage with contact at the level of the oral mucous membranes.

 Such a mouthpiece is particularly suitable for equipping electronic breathalyzers, in particular individual breathalyzers which can be portable or installed in motor vehicles.

 The nozzle according to the invention is intended to be used with a device for measuring a component of the air exhaled by an individual, such as for example a breathalyzer 12 of the electronic type and comprising a cell for measuring and memorizing value of the component measured by the cell. The breathalyzer 12 is provided with a connecting member 13 which is fitted into the tube 7 of the end piece 1 and can be connected for example by means of a connection member 14 to a receiving element provided in the dashboard of a motor vehicle. The reception element which can be analogous to that of a conventional cigarette lighter is connected to an electronic circuit of the vehicle, which receives the measurement signal delivered by the measurement cell and which is capable of processing said measurement signal and display the measured value on a screen provided for this purpose in the vehicle. In this way, each individual likely to drive the vehicle can measure their alcohol level to determine whether or not they can drive the vehicle, using their own tip.

 It is also possible to provide a device for measuring a component of the air exhaled by an individual, which includes its own means for measuring, processing and displaying the measured value, and on which the end piece would be mounted. according to the invention. In this case, a connection to an electronic circuit of the vehicle would no longer be necessary.

Claims (3)

1. Mouthpiece (1) adaptable to an expired air control device and comprising an inlet pipe (4) and an outlet pipe (7) separated by a baffle (10, 11), characterized in that the baffle (10, 11) comprises an open cell foam and in that the end piece (1) is made from treated antimicrobial materials. 2. Mouthpiece according to claim 1 characterized in that the open cell foam is a polyurethane foam. 3. Use of a mouthpiece according to claim 1 for the equipment of an electronic breathalyzer (12) capable of being integrated into equipment of a motor vehicle.