Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
  • A61B10/0045—Devices for taking samples of body liquids
  • A61B10/007—Devices for taking samples of body liquids for taking urine samples
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
  • A61B2010/0003—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements including means for analysis by an unskilled person
  • A61B2010/0006—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements including means for analysis by an unskilled person involving a colour change

Definitions

• the present invention relates to a device for collecting and analyzing bodily secretions from the urogenital region, particularly in women.
• the present invention aims in particular at the diagnosis of low urogenital infections. It may also find applications in the field of monitoring weight-loss programs, monitoring the effectiveness of slimming products, or even monitoring antibiotic therapies.
• Low urogenital infections are localized infections of the vagina, vulva and cervix.
• the infectious agents to be detected are, in particular: Candida albicans, Chlamydia trachomatis, Corynebacterium vaginalis, Enterobacteriaceae, Enterococcus, Esche ⁇ chia coli, Gardnerella vaginalis, Haemophilus vaginalis, Klebsiella, Mycoplasma hominis, Neisseria gonorrhoeae, Trichomonas vagonasum, Trichomonas vagina , Proteus mirabilis, Staphylococcus aureus, Streptococcus beta-hemolytic, Ureaplasma urealyticum.
• the chemical mechanism involves the formation of specific bio bonds with the compounds to be detected and makes it possible to measure the following parameters with regard to urinary and / or vaginal infection: leukocyte esterase (leukocyturia), nitrites, pH, albumin, glucose, ketone bodies, urobilinogens, bilirubin, hemoglobin (hematuria).
• leukocyte esterase leukocyturia
• nitrites pH, albumin, glucose, ketone bodies
• urobilinogens bilirubin
• hemoglobin hematuria
• the micro biological analysis method performs the detection of the above infectious agents in selective culture media containing a substrate metabolizable by the microorganism, growth activators, antibiotics and chromogenic molecules which allow the colorimetric identification of the pathogen. Generally, this reading is carried out in the laboratory using a spectrophotometer.
• probes for example, intended for taking samples of urogenital fluids. These probes are generally used to carry out only the sampling, possibly the transfer of the fluid to be analyzed to the analysis medium or media, generally contained in flasks, test tubes or the like, as described in document EP237394.
• a disadvantage of these procedures is that the substance to be analyzed can be contaminated, or undergo physicochemical or bacteriological modifications by the preservatives during the pre-analytical period, thus distorting the final analysis.
• this type of sample requires a gynecological procedure which can be unpleasant for the patient, and at the very least restrictive in relation to her current activity.
• a sanitary napkin of design adapted to such a sampling, integrating a sampling strip or a sampling filter.
• This device is intended to facilitate the taking of samples, but does not solve the problems of delays and errors of analysis, because it in fact only serves to collect secretions, and to facilitate their transfer to place of analysis.
• the multiple influences of sampling conditions on the reliability and accuracy of the results cannot be avoided, and in particular the influence of the time between sampling and analysis remains on the viability of microorganisms or the alkalization of urine.
• the sampling operation alone already poses many binding problems on the methodology and the means to be used, to which are added the problems means of transport and storage, the influence of preservatives on the methods and results of the analysis, time before and for analysis, commonly performed in the laboratory, and time to return the results to the patient or to his doctor, etc.
• These methods require equipment and trained personnel, have fairly long response times, and are expensive.
• the usual sampling methods can cause considerable analytical variations, which could call into question the accuracy and reliability of the test results.
• the present invention aims to provide a solution to the problems mentioned above and aims in particular to provide a means of rapid detection of urinary tract and genital infections, which is comfortable to use and allows early, rapid and most rapid diagnosis. reliable possible by the user herself, while remaining very easy to use, and of a fairly low cost.
• the invention aims to allow direct and rapid analyzes of chemical parameters and infectious germs from bodily fluids taken from specific sites in the female urogenital region. These direct analyzes relate to the detection of chemical indices of infection, the enumeration and the identification of pathogenic microorganisms.
• the invention also aims to provide a product for ensuring easy monitoring of a weight loss treatment, or a control of the effectiveness of slimming products, by assaying the ketone bodies present in the fluids collected. Still other objectives are to enable monitoring of antibiotic therapy, or to provide medical assistance for procreation or monitoring the progress of pregnancy by assaying steroid hormones such as progesterone and gonadotrophic hormone cho ⁇ onique (hCG). .
• steroid hormones such as progesterone and gonadotrophic hormone cho ⁇ onique (hCG).
• the invention relates to a device for collecting and analyzing bodily secretions from the urogenital region, comprising an absorbent support adapted to be brought, by a first face, into intimate contact with the body in the urogenital region and comprising means for withdrawing bodily fluids for their analysis, characterized in that it comprises, integrates into the volume of the absorbent support, means for in-situ analysis of said fluids and display means for viewing the results of the analysis on its surface.
• the visualization will be done on the face opposite to said first face.
• the absorbent article according to the invention allows, thanks to suitable analysis means, the detection and direct diagnosis of the chemical parameters and / or of the microorganisms responsible for low urogenital infections. It preferably comes in the form of feminine protection such as a sanitary napkin, panty liner, tampon, or even in the form of a diaper for children or a layer for incontinence.
• an upper absorbent layer of contact with the urogenital region comprising at least one site for sampling bodily fluids or samples to be analyzed, - chemical reaction media or culture media, constituting the said means of analysis, layers and absorbent and diffusing conduits for bringing the bodily fluids collected to the sampling sites to the so-called chemical reaction media or culture media, then to an overflow storage area, an external waterproof and at least locally transparent film allowing a visual reading of the results on the visualization means.
• Each culture medium or reactive zone contains a chromogen and / or colored indicator which detects the modifications of the medium caused by the metabolism of microorganisms which signals an index of infection or an identification of the pathogenic agent.
• the device will include conventionally three sampling sites, for taking samples of urine, vaginal secretions and anal secretions respectively. In other applications, one or two sampling sites may suffice.
• each sampling site corresponds to a specific sampling zone on the surface of which are distributed analysis cups containing the analysis means, in direct contact with the sampling zone, the bottom of the cups flush with the external film. .
• distribution channels extend over the surface of the sampling zone, between the analysis wells.
• the sampling zone communicates by its periphery with overflow discharge conduits which are themselves in communication with the overflow storage zone which is located between the analysis cups and the external film and isolated from the sampling area;
• each sampling zone has on its surface an impermeable film in which an opening is provided at the sampling site, and an absorbent recovery band covers all of the impermeable films and is in communication by its periphery with the storage zone overflow;
• the principle of the feminine protective towel according to the invention is based on the fact that it absorbs physiological liquids and diffuses them over the entire surface comprising the reactive zones corresponding to a sampling site concerned.
• the fluids captured by a sampling site will be able to diffuse on the surface of the corresponding sampling zone and reach the different reactive zones of this sampling zone, but will not be able to diffuse from one sampling zone to another, to avoid mixtures of fluids.
• the overflows of each sampling zone will be channeled towards the overflow storage zone, insulated and sealed from the sampling zones and the reactive zones, where the fluids can mix without discomfort, and which will therefore ensure maximum absorption capacity.
• An advantage of feminine protection of the sanitary napkin type is that it constitutes an almost ideal support, the implementation of which is particularly easy. Placed and maintained in direct contact with the body for the period necessary for the analysis, it makes it possible to directly absorb physiological fluids and bring them into contact with the reagents without delay and also as directly as possible, minimizing the risks of exogenous contamination of fluids subjected to analysis. In addition it allows to respond to classic characteristics required of female protections, namely maximum absorption of body fluids, obtained thanks to the channeling and accumulation areas of the overflow, which evacuate in the thickness of the towel, as for a conventional sanitary napkin, the volumes of fluids exceeding what is necessary to supply the reactive zones.
• the conventional dimensions of the female protections make it possible to place the reactive elements therein, even in number, fairly easily and to provide a surface on which the visualization of the results can be easily carried out and observed, giving great ease of diagnosis without that it is necessary to make specific samples.
• the u ⁇ naires examinations first use chemical detection techniques, taking into account their speed and the nature of the urine which is free from microorganisms in the normal state, these techniques constituting a good orientation diagnostic support.
• examinations of urogenital secretions are more difficult to perform due to the presence of a commensal flora coexisting with the purely pathogenic flora.
• use is preferably made of biochemical techniques on selective culture media, which make it possible to identify the infectious agents at the origin of the pathology.
• a product model could be used to provide a method of rapid chemical detection, in approximately 30 minutes, using clues of urinary tract infection; and another model will propose a semi-rapid micro-biological method using culture media making it possible to identify the pathogenic agent.
• the detection of low urogenital infections according to the invention is a rapid, simple and precise method, which makes it possible to obtain a response in a particularly short time, of less than an hour.
• the preferred type of culture medium comprises a nutrient base necessary for the development of micro ⁇ organisms, of type known per se, a growth enhancer, a chromogenic or fluorogenic substrate and one or more antibiotics inhibit ⁇ unwanted growth of micro organisms in the culture medium.
• the chromogenic or fluorogenic substrates are those conventionally used for the detection of microorganisms.
• a substrate having a hydrolysis intensity linked to a strong coloration visible to the naked eye will be chosen, a maximum enzymatic affinity for the activity to be detected and good solubility which limits the signal to the immediate vicinity of the colonies.
• the amplification of the signal by release of the chromophore or fluorophore group is visualized without requiring the use of a device such as a UV lamp or a spectrophotometer.
• Another variant of the colorimetric identification method well known to those skilled in the art, consists in introducing into the culture medium substances which detect the slight changes generated by the growth of microorganisms.
• activators can be added to the culture medium to potentiate the enzymatic activity to be detected. They may be hexosamines, bivalent cationic compound salts such as the salts of Mn 2+ , Mg 2+ , Ca 2 X
• Permeabilization agents or surfactants can also be added to promote better enzyme-substrate bonding.
• the culture medium contains at least one inhibitor of microorganisms not sought.
• This inhibitor in the presence of other constituents of the medium, including the chromogenic compounds, makes it possible to obtain a culture medium entirely specific to the kind of microorganism sought.
• the culture medium allows specific detection as well as the counting of the microorganisms sought.
• FIG. 1 is a plan view of the towel illustrating the arrangement of the different elements which constitute it, it being understood that these different elements are integrated into the thickness of the towel and therefore not really visible from the outside;
• FIG. 2 is a cross-sectional view, on an enlarged scale, along the line II-II of FIG. 1
• FIG. 3 is a partial view in longitudinal section along the line III-III of FIG. 1
• FIG. 4 is a very schematic view in longitudinal section illustrating the juxtaposition of the three sampling zones
• FIG. 5 is a side view of an alternative embodiment, intended to improve the accuracy of the location of the samples
• each zone has an upper bulge corresponding, as will be seen below, to the sampling sites 110, 120, 130.
• bulges correspond respectively to the location of the unary meatus for the detection zone 11, from the vaginal canal for the detection zone 12, and to the anus for the detection zone 13. They make it possible to ensure optimal contact with the parts of the body which are the origins of the secretions to be analyzed.
• the particular shape of the suction cup given to the sampling sites aims to ensure even closer and above all very localized contact with the sources of the secretions, in particular for carrying out very localized sampling, and thus avoiding as much as possible disturbances that could be caused by absorption in the secretion collection areas contaminants from the periphery of the secretion sources to be analyzed.
• the detection device 1 comprises an envelope constituted, on the side of the upper face 2 intended to be placed in contact with the body, by a contact veil 21, of soft and porous material, covering the entire upper surface, and on the side opposes 3, downwards, an impermeable film 22, for example a thin film of plastic material, resistant to traction and to chemicals, which is connected to the contact veil by enveloping the periphery of the towel, as is see Figure 2, and which seals the device to the outside.
• a contact veil 21 of soft and porous material, covering the entire upper surface, and on the side opposes 3, downwards, an impermeable film 22, for example a thin film of plastic material, resistant to traction and to chemicals, which is connected to the contact veil by enveloping the periphery of the towel, as is see Figure 2, and which seals the device to the outside.
• each sampling zone is formed of an absorbent layer 27, for example of pure cotton (constituted by a succession of cellulose patterns) or of another material based on cellulose, cellulose acetate or other derivatives, or else d 'other highly absorbent materials offering good resistance and porosity characteristics, in relatively reduced thicknesses.
• Each absorbent layer 27 rests on a flexible plate 28 of impermeable material, shaped so as to have a plurality of analysis cups 29 of truncated shape and which extend up to the film. sealed 22.
• Each well 29 contains a chemical reagent or a reaction medium specifically intended to ensure the detection of an infectious agent.
• the bottom of each well is in contact with the waterproof and transparent film 22, which thus makes it possible to visualize the changes in color in the wells caused by the reaction of the chemical reagent or of the culture medium with the fluids withdrawn and directed towards the wells.
• the absorbent layer 27 ensures by capillarity the transfer of the fluids captured through the opening 26 towards the chemical reaction media or culture media predisposed in the wells.
• the ratio of the total surface of the absorbent layer 27 to the total surface of the openings of the wells is high, which promotes the penetration of fluids captured in the wells and the rapid filling of the wells, even those located furthest from the sampling site.
• This filling can also be favored by the existence of a vacuum provided for this purpose in the analysis wells, which also prevents the phenomena of overloading or dilution of the reagents.
• diffusion channels 30 are preferably made on the surface of the plate 28 to accelerate and homogenize the distribution of the fluids over the entire surface of the plate and therefore in the various analysis wells.
• the analysis wells preferably have a frustoconical shape favorable to better contact of fluids with the reaction medium which they contain.
• the reaction chamber formed by the bottom of the wells 29 will preferably be designed so as not to be completely full and to retain an air bubble which promotes mixing of the reaction medium.
• the addition of body fluid is achieved by direct aspiration in the reaction chamber which contains the reagents necessary for carrying out the reactions for detecting infectious agents.
• These wells are preferably made of a material such as polypropylene which ensures good heat distribution and maintains the temperature around 37 ° C. in the wells, which constitutes a micro-incubator necessary for the growth of microorganisms and upon detection.
• absorbent and diffusing strips or conduits 31, 32 are arranged, in contact with the edges of the absorbent layer 27, to redirect the fluid overflow to the overflow storage area 23 , consisting of a very absorbent material distributed between the plate 28 and the film 22, in the intervals between the cups 29.
• the diffusion channels 30 preferably extend longitudinally to distribute the fluids as well as possible, and open into the excess conduits -full 32, as seen in Figure 1.
• Holding cups 33 are preferably arranged in the overflow storage zone, between the analysis cups, as seen in FIGS. 2 and 3. These cups can also be produced in the form of a preformed plate as plate 28. They are also tapered, inverted with respect to the analysis cups, pierced and filled with a very absorbent material. In addition to their participation in the collection of the overflow, they give a certain rigidity to the device by preventing its crushing and therefore the deformation of the analysis cups, which ensures the maintenance of the initial reaction volume and therefore the accuracy and reproducibility of the results of the analyzes.
• the impermeable film 25 extends over and around the sampling zones, to border them outwards and separate them from one another. It thus avoids a mixing by diffusion of fluids from neighboring sampling sites. It also avoids mixing of the contaminating fluids captured by the recovery band 24 with the fluids to be analyzed captured by the absorbent layers 27.
• the band 24 extends along the edges of the napkin by forming peripheral drainage channels 34 which transfer the secretions contaminating towards the side overflow strips 31 and the overflow storage area 23.
• 6 to 8 show by way of illustration various possibilities, in no way limiting, of arrangements of display means on the side of the lower face , that is to say the one on which the results of the analyzes are made visible by change of color of the reagents contained in the wells 29, the change in color being perceived through the bottom 35 of the wells and of the external film 22.
• FIG. 6 shows for example a set of ten indicator zones 35 corresponding to ten chemical type analyzes, that is to say rapid tests, for example leukocyte esterase, nitrites, pH, albumin, glucose, ketone bodies, proteins, hemoglobin, bilirubin, urobilmogene.
• FIG. 6 shows for example a set of ten indicator zones 35 corresponding to ten chemical type analyzes, that is to say rapid tests, for example leukocyte esterase, nitrites, pH, albumin, glucose, ketone bodies, proteins, hemoglobin, bilirubin, urobilmogene.
• FIG. 7 similarly shows the indicator zones 35 in the case of semi-rapid tests for the detection of infectious agent, such as for example: Esche ⁇ chia coli, Neisse ⁇ a gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Yeasts, Herpes simplex, Candida albicans, Staphylococcus aureus, Pseudomonas aeruginosa.
• infectious agent such as for example: Esche ⁇ chia coli, Neisse ⁇ a gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Yeasts, Herpes simplex, Candida albicans, Staphylococcus aureus, Pseudomonas aeruginosa.
• FIG. 8 illustrates the case of a device used for the detection of chemical slimming indices, by presenting colored indicators of: acetone, aceto-acetic acid, beta-hydroxybuty ⁇ que acid, glucose, creatinme.
• the invention is not limited to the embodiment described above solely by way of example, and the technology of embodiment can be modified and adapted without departing from the scope of the invention as defined by the appended claims.
• a person skilled in the art can easily adapt the topology and the nature of the reagents to detect other pathologies or physiological states, for example: detection of chemical indicators of thinness, osteoporosis, nephropathy, myopathies, detection of infectious diseases (typhoid fever, measles, tuberculosis, pneumonia, general sarcomas or Hodgkin's disease), detection of intoxication (lead, phosphorus, mercury, cadmium, uranium, bismuth), avitaminosis, detection of mental retardation , detection of bone tumors, hyperparathyroidism, prenatal diagnosis of congenital malformations, diagnosis of pregnancy, medically assisted procreation, monitoring of the progress of pregnancy, etc.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Pathology (AREA)
• Engineering & Computer Science (AREA)
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• Hematology (AREA)
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• Molecular Biology (AREA)
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• Animal Behavior & Ethology (AREA)
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• 1999
  • 1999-05-19 FR FR9906441A patent/FR2793883A1/fr active Pending
• 2000
  • 2000-05-05 WO PCT/FR2000/001213 patent/WO2000072009A1/fr not_active Application Discontinuation
  • 2000-05-05 EP EP00925395A patent/EP1097376A1/de not_active Withdrawn

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