WO2020039420A2 - Device for the detection of vaginal diseases - Google Patents

Device for the detection of vaginal diseases Download PDF

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Publication number
WO2020039420A2
WO2020039420A2 PCT/IB2019/061324 IB2019061324W WO2020039420A2 WO 2020039420 A2 WO2020039420 A2 WO 2020039420A2 IB 2019061324 W IB2019061324 W IB 2019061324W WO 2020039420 A2 WO2020039420 A2 WO 2020039420A2
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WIPO (PCT)
Prior art keywords
vaginal
vial
detection
absorbent
pathogen
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PCT/IB2019/061324
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Spanish (es)
French (fr)
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WO2020039420A3 (en
Inventor
Alice Mathilde Jeanine MONCORGER
Cecilia CEMPINI
Paola Ximena DALGO AGUILAR
Roberto Carlos CUENCA JIMENEZ
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Universidad Técnica Particular De Loja
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Priority to PCT/IB2019/061324 priority Critical patent/WO2020039420A2/en
Publication of WO2020039420A2 publication Critical patent/WO2020039420A2/en
Publication of WO2020039420A3 publication Critical patent/WO2020039420A3/en

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    • 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
    • A61B10/02—Instruments for taking cell samples or for biopsy

Definitions

  • the object of the present invention is a device for domestic use for the detection of vaginal pathogens by means of a colorimetric detection system without the need for medical intervention.
  • the invention belongs to the technical field of domestic devices for the detection of vaginal diseases.
  • vaginal pathogens sexually transmitted diseases or diseases caused by vaginal pathogens are the main vaginal diseases that women suffer. The importance of early diagnosis and proper treatment is vital for the recovery of the patient.
  • vaginal pathogens Some of the most relevant vaginal pathogens are human papillomavirus (HPV), a group of viruses that can cause from warts to cervical cancer, vulvar and vaginal cancer in women.
  • HPV human papillomavirus
  • US4633886 A describes a device for the domestic detection of vaginal cancer comprising an aspiration element of the vaginal cells, a container with a breakable membrane to maintain the sterility of the device and a fixation solution to keep the cells intact to send it to the laboratory.
  • a device for own use of intravaginal sample collection is described to subsequently test the presence of HPV comprising a tube for inserting a finger next to a collection part for the vaginal sample.
  • a device that by means of an enzymatic assay allows the detection of viruses from a clinical sample in the absence of cell cultures, in particular the virus influenza.
  • the inventors have developed a device for domestic use for the detection of vaginal diseases without the need for external intervention.
  • the device comprises a colorimetric detection system that, in contact with pathogens found in vaginal tissues, allows diagnosis of a vaginal disease.
  • the device is formed by an internal vial comprising the colorimetric reagents for the detection of the pathogen, surrounded by an absorbent cover, within a rigid support next to an applicator, preferably removable or expandable.
  • the applicator comprises a perforating element that allows the vial to break with the reagents, which, depending on the presence of pathogens, allow a visible color change of the coverage, indicating the clinical diagnosis to the user. Therefore, a first aspect of the present invention is a device for the detection of vaginal diseases for domestic use, hereinafter the device of the invention, comprising:
  • the envelope of the device of the invention supports and protects the elements of the device: the vial with the colorimetric reagents, the absorbent encapsulation, the piercing element and the applicator.
  • the wrap is preferably made of a rigid material to prevent rupture of the device, flexible to facilitate its sliding through the vaginal cavity and of a hypoallergenic material to help reduce the risk of causing an allergic symptom or reaction in the patient.
  • the envelope material of the device of the invention is selected from the list which, without limitation, consists of: plastic, polyethylene, polypropylene, polystyrene, stainless steel, niobium, titanium, surgical steel, silicone, viscose and Any combination of them.
  • the vial of the device of the invention comprises at least one colorimetric detection reagent against vaginal pathogens.
  • Such reagents allow to carry out a colorimetric immuno-enzymatic reaction in the presence of the pathogen, significantly changing its color.
  • These reagents are able to react specifically with some element of the pathogen, such as membrane proteins or antigens, modifying the color of the sample solution and therefore of the absorbent encapsulation, thus diagnosing a vaginal disease.
  • the perforating element arranged next to the applicator, breaks or fractures the vial allowing the dispersion of the reagents through the absorbent encapsulation where said absorbent encapsulation changes color in the presence of a vaginal pathogen.
  • Said perforating element is a rigid element with a pointed end capable of penetrating into the vial, by sliding or moving towards it, breaking it and releasing the reagents.
  • the piercing element is selected from the list which, without limitation, consists of: needle, die, drill, spine, pin, skewer, barb, punch, nail, awl, stiletto and buril.
  • the piercing element is disposed inside the applicator, where the applicator next to the perforator, slides through the inside of the device casing, once inserted into the vagina, and performs the rupture of the vial releasing reagents to absorbent encapsulation.
  • the device of the invention can also comprise a sensor for detecting other vaginal biological parameters that may be indicators of suffering from a vaginal disease and the stage or severity of said disease.
  • the device of the invention further comprises at least one sensor for detecting a biological parameter that is selected from the list consisting of: pH, non-pathogenic vaginal flora, succinic acid, butyric acid, acetic acid and lactic acid.
  • said detection sensor of a biological parameter is an electrical sensor.
  • the results obtained in the device of the invention, both of the colorimetric reaction of pathogen detection and the results of the detection sensor of a biological parameter, can be transferred to another device by means of a wireless data transmission module.
  • the device of the invention further comprises at least one wireless data transmission module.
  • Said wireless data transmission module sends the data to another device via bluetooth, Wi-Fi, infrared, radio waves, radio frequency identification (RFID), which allow the transmission of the information of the device of the invention to another device such as, for For example, a computer, tablet, mobile phone or smartphone.
  • RFID radio frequency identification
  • the wireless data transmission module is connected to the detection sensor of a biological parameter.
  • the absorbent encapsulation that covers the vial allows, once the vial is fractured and the colorimetric reagents released, to absorb said colorimetric reagents and facilitate the reaction between said reagents and the pathogens present in the vagina. Because this device is inserted into the vaginal cavity, the absorbent encapsulation as well as the wrap are made of a hypoallergenic material that helps reduce the risk of causing an allergic reaction or symptom in the patient.
  • the absorbent encapsulation of the device of the invention is made of a hypoallergenic material that can be natural, synthetic or a combination of both.
  • said hypoallergenic material is selected from the list consisting of: cotton, wool, viscose, silk, polypropylene fiber and polyester fiber.
  • the applicator of the device of the invention allows said device, more specifically the wrapper, to be inserted into the vaginal cavity and to facilitate the rupture of the vial with the perforator to carry out the colorimetric reaction with a vaginal pathogen.
  • said applicator is extensible.
  • the device comprises a withdrawal element to facilitate expulsion of the device from the vagina to the outside.
  • the device removal element is a thread, preferably a thread of a hypoallergenic material.
  • the colorimetric reagents of the vial of the device of the invention allow to carry out a colorimetric immuno-enzymatic reaction in the presence of a pathogen by significantly changing its color, thus diagnosing a vaginal disease.
  • the vaginal pathogen is selected from the list consisting of: human papillomavirus, chlamydia, candida, mycoplasma, herpes simplex virus, streptococci and gardnerella.
  • vaginal pathogen is the human papillomavirus.
  • said vial may also comprise reagents for the detection of the patient's pregnancy.
  • the device further comprises a pregnancy detection reagent.
  • the device of the invention allows the detection of vaginal diseases without the need for external intervention, such as a doctor or laboratory analysis, allowing the user to have a quick and simple diagnosis.
  • the user can determine and identify the vaginal disease he suffers or determine if there is pregnancy, in a visual way.
  • the device of the invention further comprises an element for colorimetric assessment of the color of the absorbent package in the presence of a vaginal pathogen or a pregnancy.
  • the colorimetric assessment element can be a gradual color scale or a colorimetric band, which identifies a vaginal disease or pregnancy with a certain color.
  • Figure 1 Internal front view of a preferred embodiment of the device of the invention.
  • FIG. 3 Detailed view of the interior of the vial in a preferred embodiment of the device of the invention.
  • Figure 4 View of the packaging of the disease detection device in a preferred embodiment.
  • Figure 1 shows an internal front view of a preferred embodiment of the device comprising in its interior a vial (2) with the colorimetric detection reagents (3) for the detection of the vaginal pathogen coated by an absorbent encapsulation (1). Also shown in the figure is the withdrawal element (4) composed of a wire connected to the device.
  • Figure 2 shows an external front view of a preferred embodiment of the device comprising a wrapper (5), which supports and protects the elements of the device, attached to the extensible applicator (6) which comprises in its interior the piercing element (7) .
  • Figure 3 shows a detailed view of the inside of the vial (2) comprising the colorimetric detection reagents (3) in a preferred embodiment of the device.
  • Figure 3 shows the moment of rupture of the vial by means of the piercing element (7) and the release of the colorimetric detection reagents.
  • Figure 4 shows a view of a preferred embodiment of the packaging of the device comprising a box (8) comprising the device (9) inserted and a colorimetric band (10) indicating the values and diagnosis of the test.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The present invention relates to a home-use device for diagnosing vaginal diseases. The device is formed by a vial comprising colorimetric reagents for determining pathogens, which is encapsulated in an absorbent casing, together with an applicator. The applicator comprises a perforating element allowing the vial to be broken and, in the presence of pathogenic agents, the colour of the absorbent casing to change, indicating the clinical diagnosis to the user.

Description

DISPOSITIVO PARA LA DETECCIÓN DE ENFERMEDADES VAGINALES  DEVICE FOR THE DETECTION OF VAGINAL DISEASES
OBJETO DE LA INVENCIÓN OBJECT OF THE INVENTION
El objecto de la presente invención es un dispositivo de uso doméstico para la detección de patógenos vaginales mediante un sistema de detección colorimétrico sin necesidad de intervención médica. Así, la invención pertenece al campo técnico de dispositivos domésticos para la detección de enfermedades vaginales. The object of the present invention is a device for domestic use for the detection of vaginal pathogens by means of a colorimetric detection system without the need for medical intervention. Thus, the invention belongs to the technical field of domestic devices for the detection of vaginal diseases.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
Las enfermedades de transmisión sexual o las enfermedades causadas por patógenos vaginales son las principales enfermedades vaginales que sufren las mujeres. La importancia de un diagnóstico precoz y un tratamiento adecuado es vital para la recuperación del paciente. Sexually transmitted diseases or diseases caused by vaginal pathogens are the main vaginal diseases that women suffer. The importance of early diagnosis and proper treatment is vital for the recovery of the patient.
Algunos de los patógenos vaginales más relevantes son los virus del papiloma humano (VPH), un grupo de virus que pueden ocasionar desde verrugas hasta cáncer de cuello uterino, cáncer de vulva y de vagina en las mujeres. Some of the most relevant vaginal pathogens are human papillomavirus (HPV), a group of viruses that can cause from warts to cervical cancer, vulvar and vaginal cancer in women.
Existen en el estado de la técnica diferentes tipos de dispositivos para la detección de patógenos vaginales, así como enfermedades vaginales. Por ejemplo, el documento US4633886 A describe un dispositivo para la detección doméstica de cáncer vaginal que comprende un elemento de aspiración de las células vaginales, un contenedor con una membrana rompible para mantener la esterilidad del dispositivo y una solución de fijación para mantener las células intactas para enviarlo al laboratorio. There are different types of devices for the detection of vaginal pathogens in the state of the art, as well as vaginal diseases. For example, US4633886 A describes a device for the domestic detection of vaginal cancer comprising an aspiration element of the vaginal cells, a container with a breakable membrane to maintain the sterility of the device and a fixation solution to keep the cells intact to send it to the laboratory.
En el documento US201701 12478 A1 se describe un dispositivo de uso propio de recolección de muestra intravaginal para posteriormente testar la presencia del VPH que comprende un tubo para introducir un dedo junto a una parte recolectora para la muestra vaginal. Para la detección de virus existen en el estado de la técnica dispositivos como el que se describe en el documento US5766841 A, un dispositivo que mediante un ensayo enzimático permite la detección de virus de una muestra clínica en ausencia de cultivos celulares, en concreto del virus influenza. In US201701 12478 A1 a device for own use of intravaginal sample collection is described to subsequently test the presence of HPV comprising a tube for inserting a finger next to a collection part for the vaginal sample. For the detection of viruses there are devices in the state of the art such as the one described in US5766841 A, a device that by means of an enzymatic assay allows the detection of viruses from a clinical sample in the absence of cell cultures, in particular the virus influenza.
La mayoría de los dispositivos conocidos en el estado de la técnica son aparatos de recolección de muestras biológicas vaginales que necesitan un profesional para su procesamiento y posterior análisis, tienen riesgos de contaminación y/o desnaturalización de la muestra biológica en su manipulación y transporte a un laboratorio y suelen tener un costo elevado. Most of the devices known in the state of the art are devices for the collection of vaginal biological samples that need a professional for processing and subsequent analysis, have risks of contamination and / or denaturation of the biological sample in its handling and transport to a laboratory and usually have a high cost.
Por tanto, se hace necesario desarrollar nuevos dispositivos para la detección y análisis de enfermedades vaginales, de uso doméstico y que permita un fácil diagnóstico, es decir, que no requiera que el usuario tenga conocimientos técnicos específicos de la materia para comprender los resultados y el análisis de la muestra vaginal. Therefore, it is necessary to develop new devices for the detection and analysis of vaginal diseases, for domestic use and that allows an easy diagnosis, that is, that does not require the user to have specific technical knowledge of the subject to understand the results and the Vaginal sample analysis.
DESCRIPCIÓN DE LA INVENCIÓN DESCRIPTION OF THE INVENTION
Los inventores han desarrollado un dispositivo de uso doméstico para la detección de enfermedades vaginales sin necesidad de intervención externa. El dispositivo comprende un sistema de detección colorimétrico que, en contacto con patógenos que se encuentran en los tejidos vaginales, permite diagnosticar una enfermedad vaginal. The inventors have developed a device for domestic use for the detection of vaginal diseases without the need for external intervention. The device comprises a colorimetric detection system that, in contact with pathogens found in vaginal tissues, allows diagnosis of a vaginal disease.
El dispositivo está conformado por un vial interno que comprende los reactivos colorimétricos para la detección del patógeno, rodeado por una cobertura absorbente, dentro de un soporte rígido junto a un aplicador, preferiblemente extraíble o expandible. El aplicador comprende un elemento perforador que permite romper el vial con los reactivos, que en función de la presencia de agentes patógenos, permitan un cambio de color visible de la cobertura, indicando al usuario el diagnóstico clínico. Por tanto, un primer aspecto de la presente invención es un dispositivo para la detección de enfermedades vaginales de uso doméstico, de aquí en adelante el dispositivo de la invención, que comprende: The device is formed by an internal vial comprising the colorimetric reagents for the detection of the pathogen, surrounded by an absorbent cover, within a rigid support next to an applicator, preferably removable or expandable. The applicator comprises a perforating element that allows the vial to break with the reagents, which, depending on the presence of pathogens, allow a visible color change of the coverage, indicating the clinical diagnosis to the user. Therefore, a first aspect of the present invention is a device for the detection of vaginal diseases for domestic use, hereinafter the device of the invention, comprising:
- una envoltura,  - a wrap,
- un vial que comprende al menos un reactivo de detección colorimétrica frente a un patógeno vaginal, donde el vial está situado en el interior de la envoltura,  - a vial comprising at least one colorimetric detection reagent against a vaginal pathogen, where the vial is located inside the envelope,
- un encapsulado absorbente que recubre el vial, donde el encapsulado absorbente está situado en el interior de la envoltura,  - an absorbent encapsulation covering the vial, where the absorbent encapsulation is located inside the envelope,
- al menos un elemento perforador situado en el interior de la envoltura, - at least one perforating element located inside the envelope,
- al menos un aplicador dispuesto junto al elemento perforador en el interior de la envoltura, y - at least one applicator disposed next to the piercing element inside the envelope, and
- un elemento de retirada del dispositivo conectado a la envoltura, donde el elemento perforador se desliza por el interior de la envoltura y rompe el vial permitiendo la dispersión de los reactivos de detección colorimétrica a través del encapsulado absorbente, donde dicho encapsulado absorbente cambia de color en presencia de un patógeno vaginal.  - a withdrawal element of the device connected to the envelope, where the perforating element slides through the interior of the envelope and breaks the vial allowing the dispersion of the colorimetric detection reagents through the absorbent package, where said absorbent package changes color in the presence of a vaginal pathogen.
La envoltura del dispositivo de la invención da soporte y protege a los elementos del dispositivo: el vial con los reactivos colorimétricos, el encapsulado absorbente, el elemento perforador y el aplicador. La envoltura preferiblemente es de un material rígido para evitar la ruptura del dispositivo, flexible para facilitar su deslizamiento por la cavidad vaginal y de un material hipoalergénico para que ayude a disminuir el riesgo de provocar un síntoma o reacción alérgica en el paciente. The envelope of the device of the invention supports and protects the elements of the device: the vial with the colorimetric reagents, the absorbent encapsulation, the piercing element and the applicator. The wrap is preferably made of a rigid material to prevent rupture of the device, flexible to facilitate its sliding through the vaginal cavity and of a hypoallergenic material to help reduce the risk of causing an allergic symptom or reaction in the patient.
En una realización preferida, el material de la envoltura del dispositivo de la invención se selecciona de la lista que, sin limitar, consiste en: plástico, polietileno, polipropileno, poliestireno, acero inoxidable, niobio, titanio, acero quirúrgico, silicona, viscosa y cualquier combinación de ellos. In a preferred embodiment, the envelope material of the device of the invention is selected from the list which, without limitation, consists of: plastic, polyethylene, polypropylene, polystyrene, stainless steel, niobium, titanium, surgical steel, silicone, viscose and Any combination of them.
El vial del dispositivo de la invención comprende al menos un reactivo de detección colorimétrica frente a patógenos vaginales. Dichos reactivos permiten llevar a cabo una reacción inmuno-enzimática colorimétrica en presencia del patógeno, cambiando significativamente su color. Dichos reactivos son capaces de reaccionar específicamente con algún elemento del patógeno, tal como proteínas de membrana o antígenos, modificando el color de la solución de la muestra y por tanto del encapsulado absorbente, diagnosticando así una enfermedad vaginal. The vial of the device of the invention comprises at least one colorimetric detection reagent against vaginal pathogens. Such reagents allow to carry out a colorimetric immuno-enzymatic reaction in the presence of the pathogen, significantly changing its color. These reagents are able to react specifically with some element of the pathogen, such as membrane proteins or antigens, modifying the color of the sample solution and therefore of the absorbent encapsulation, thus diagnosing a vaginal disease.
El elemento perforador, dispuesto junto al aplicador, rompe o fractura el vial permitiendo la dispersión de los reactivos a través del encapsulado absorbente donde dicho encapsulado absorbente cambia de color en presencia de un patógeno vaginal. The perforating element, arranged next to the applicator, breaks or fractures the vial allowing the dispersion of the reagents through the absorbent encapsulation where said absorbent encapsulation changes color in the presence of a vaginal pathogen.
Dicho elemento perforador es un elemento rígido con un extremo puntiagudo capaz de, mediante su deslizamiento o movimiento hacia el vial, penetrar dentro de él, rompiéndolo y liberando los reactivos. Said perforating element is a rigid element with a pointed end capable of penetrating into the vial, by sliding or moving towards it, breaking it and releasing the reagents.
En otra realización preferida el elemento perforador se selecciona de la lista que, sin limitar, consiste en: aguja, troquel, taladro, espina, alfiler, pincho, púa, punzón, clavo, lezna, estilete y buril. In another preferred embodiment, the piercing element is selected from the list which, without limitation, consists of: needle, die, drill, spine, pin, skewer, barb, punch, nail, awl, stiletto and buril.
En otra realización más preferida, el elemento perforador se encuentra dispuesto en el interior del aplicador, donde el aplicador junto al perforador, se deslizan por el interior de la envoltura del dispositivo, una vez insertado en la vagina, y llevan a cabo la ruptura del vial liberizando los reactivos al encapsulado absorbente. In another more preferred embodiment, the piercing element is disposed inside the applicator, where the applicator next to the perforator, slides through the inside of the device casing, once inserted into the vagina, and performs the rupture of the vial releasing reagents to absorbent encapsulation.
El dispositivo de la invención además puede comprender un sensor de detección de otros parámetros biológicos vaginales que pueden ser indicadores de padecer una enfermedad vaginal y del estadio o gravedad de dicha enfermedad. The device of the invention can also comprise a sensor for detecting other vaginal biological parameters that may be indicators of suffering from a vaginal disease and the stage or severity of said disease.
Por tanto, en otra realización preferida el dispositivo de la invención además comprende al menos un sensor de detección de un parámetro biológico que se selecciona de la lista que consiste en: pH, flora vaginal no patogénica, ácido succínico, ácido butírico, ácido acético y ácido láctico. Therefore, in another preferred embodiment the device of the invention further comprises at least one sensor for detecting a biological parameter that is selected from the list consisting of: pH, non-pathogenic vaginal flora, succinic acid, butyric acid, acetic acid and lactic acid.
En otra realización más preferida, dicho sensor de detección de un parámetro biológico es un sensor eléctrico. Los resultados obtenidos en el dispositivo de la invención, tanto de la reacción colorimétrica de detección de patógenos como los resultados del sensor de detección de un parámetro biológico, pueden ser transferidos a otro dispositivo mediante un módulo de transmisión inalámbrica de datos. In another more preferred embodiment, said detection sensor of a biological parameter is an electrical sensor. The results obtained in the device of the invention, both of the colorimetric reaction of pathogen detection and the results of the detection sensor of a biological parameter, can be transferred to another device by means of a wireless data transmission module.
Así, en otra realización preferida el dispositivo de la invención además comprende al menos un módulo de transmisión inalámbrica de datos. Thus, in another preferred embodiment the device of the invention further comprises at least one wireless data transmission module.
Dicho módulo de transmisión inalámbrica de datos envía los datos a otro dispositivo mediante bluetooth, Wi-Fi, infrarrojos, ondas radio, identificación por radiofrecuencia (RFID), que permiten la transmisión de la información del dispositivo de la invención a otro dispositivo como, por ejemplo, un ordenador, tablet, teléfono móvil o smartphone. Said wireless data transmission module sends the data to another device via bluetooth, Wi-Fi, infrared, radio waves, radio frequency identification (RFID), which allow the transmission of the information of the device of the invention to another device such as, for For example, a computer, tablet, mobile phone or smartphone.
En otra realización aún más preferida, el módulo de transmisión inalámbrica de datos está conectado al sensor de detección de un parámetro biológico. In another even more preferred embodiment, the wireless data transmission module is connected to the detection sensor of a biological parameter.
El encapsulado absorbente que recubre el vial permite, una vez fracturado el vial y liberados los reactivos colorimétricos, absorber dichos reactivos colorimétricos y facilitar la reacción entre dichos reactivos y los patógenos presentes en la vagina. Debido a que este dispositivo se introduce dentro de la cavidad vaginal, el encapsulado absorbente al igual que la envoltura, son de un material hipoalergénico que ayude a disminuir el riesgo de provocar un síntoma o reacción alérgica en el paciente. The absorbent encapsulation that covers the vial allows, once the vial is fractured and the colorimetric reagents released, to absorb said colorimetric reagents and facilitate the reaction between said reagents and the pathogens present in the vagina. Because this device is inserted into the vaginal cavity, the absorbent encapsulation as well as the wrap are made of a hypoallergenic material that helps reduce the risk of causing an allergic reaction or symptom in the patient.
Así en otra realización preferida, el encapsulado absorbente del dispositivo de la invención es de un material hipoalergénico que puede ser natural, sintético o de una combinación de ambos. Thus in another preferred embodiment, the absorbent encapsulation of the device of the invention is made of a hypoallergenic material that can be natural, synthetic or a combination of both.
En otra realización más preferida, dicho material hipoalergénico se selecciona de la lista que consiste en: algodón, lana, viscosa, seda, fibra de polipropileno y fibra de poliéster. El aplicador del dispositivo de la invención permite introducir dicho dispositivo, más concretamente la envoltura, en el interior de la cavidad vaginal y facilitar la ruptura del vial con el perforador para llevar a cabo la reacción colorimétrica con un patógeno vaginal. In another more preferred embodiment, said hypoallergenic material is selected from the list consisting of: cotton, wool, viscose, silk, polypropylene fiber and polyester fiber. The applicator of the device of the invention allows said device, more specifically the wrapper, to be inserted into the vaginal cavity and to facilitate the rupture of the vial with the perforator to carry out the colorimetric reaction with a vaginal pathogen.
En otra realización preferida, dicho aplicador es extensible. In another preferred embodiment, said applicator is extensible.
Una vez llevada a cabo la reacción de detección colorimétrica de un patógeno vaginal, el dispositivo comprende un elemento de retirada para facilitar la expulsión del dispositivo de la vagina al exterior. Once the colorimetric detection reaction of a vaginal pathogen is carried out, the device comprises a withdrawal element to facilitate expulsion of the device from the vagina to the outside.
En otra realización preferida, el elemento de retirada del dispositivo es un hilo, preferiblemente un hilo de un material hipoalergénico. In another preferred embodiment, the device removal element is a thread, preferably a thread of a hypoallergenic material.
Los reactivos colorimétricos del vial del dispositivo de la invención permiten llevar a cabo una reacción inmuno-enzimática colorimétrica en presencia de un patógeno cambiando significativamente su color, diagnosticando así una enfermedad vaginal. The colorimetric reagents of the vial of the device of the invention allow to carry out a colorimetric immuno-enzymatic reaction in the presence of a pathogen by significantly changing its color, thus diagnosing a vaginal disease.
En otra realización preferida, el patógeno vaginal se selecciona de la lista que consiste en: virus papiloma humano, clamidia, cándida, micoplasma, virus herpes simple, estreptococos y gardnerella. In another preferred embodiment, the vaginal pathogen is selected from the list consisting of: human papillomavirus, chlamydia, candida, mycoplasma, herpes simplex virus, streptococci and gardnerella.
En otra realización más preferida el patógeno vaginal es el virus del papiloma humano. In another more preferred embodiment the vaginal pathogen is the human papillomavirus.
Además de los reactivos colorimétricos que comprende el vial del dispositivo de la invención, dicho vial además puede comprender reactivos para la detección del embarazo del paciente. Así en otra realización preferida, el dispositivo además comprende un reactivo de detección de embarazo. In addition to the colorimetric reagents comprising the vial of the device of the invention, said vial may also comprise reagents for the detection of the patient's pregnancy. Thus in another preferred embodiment, the device further comprises a pregnancy detection reagent.
El dispositivo de la invención permite la detección de enfermedades vaginales sin necesidad de intervención externa, como por ejemplo de un médico o del análisis de un laboratorio, permitiendo al usuario tener un diagnóstico rápido y sencillo. Mediante un elemento de valoración colorimétrica del color del encapsulado absorbente resultante en presencia de un patógeno vaginal o de un embarazo, el usuario puede determinar e identificar la enfermedad vaginal que padece o determinar si hay embarazo, de una manera visual. The device of the invention allows the detection of vaginal diseases without the need for external intervention, such as a doctor or laboratory analysis, allowing the user to have a quick and simple diagnosis. By means of an element of colorimetric assessment of the color of the absorbent encapsulation resulting in the presence of a vaginal pathogen or a pregnancy, the user can determine and identify the vaginal disease he suffers or determine if there is pregnancy, in a visual way.
Así, en otra realización preferida el dispositivo de la invención además comprende un elemento de valoración colorimétrica del color del encapsulado absorbente en presencia de un patógeno vaginal o de un embarazo. Thus, in another preferred embodiment, the device of the invention further comprises an element for colorimetric assessment of the color of the absorbent package in the presence of a vaginal pathogen or a pregnancy.
Por ejemplo, el elemento de valoración colorimétrica puede ser una escala gradual de colores o una banda colorimétrica, que identifique una enfermedad vaginal o el embarazo con un color determinado. For example, the colorimetric assessment element can be a gradual color scale or a colorimetric band, which identifies a vaginal disease or pregnancy with a certain color.
DESCRIPCIÓN DE LOS DIBUJOS DESCRIPTION OF THE DRAWINGS
Figura 1. Vista frontal interna de una realización preferida del dispositivo de la invención. Figure 1. Internal front view of a preferred embodiment of the device of the invention.
Figura 2. Vista frontal externa de una realización preferida del dispositivo de la invención. Figure 2. External front view of a preferred embodiment of the device of the invention.
Figura 3. Vista en detalle del interior del vial en una realización preferida del dispositivo de la invención. Figure 3. Detailed view of the interior of the vial in a preferred embodiment of the device of the invention.
Figura 4. Vista del empaquetamiento del dispositivo de detección de enfermedades en una realización preferida. Figure 4. View of the packaging of the disease detection device in a preferred embodiment.
REALIZACIÓN PEFERENTE DE LA INVENCIÓN PREFERRED EMBODIMENT OF THE INVENTION
Con la ayuda de las figuras 1 , 2, 3 y 4, se expone a continuación una realización preferida del dispositivo de la invención para la detección de enfermedades vaginales. With the aid of Figures 1, 2, 3 and 4, a preferred embodiment of the device of the invention for the detection of vaginal diseases is set forth below.
La figura 1 muestra una vista frontal interna de una realización preferida del dispositivo que comprende en su interior un vial (2) con los reactivos de detección colorimétrica (3) para la detección del patógeno vaginal recubierto por un encapsulado absorbente (1 ). También se muestra en la figura el elemento de retirada (4) compuesto por un hilo conectado al dispositivo. Figure 1 shows an internal front view of a preferred embodiment of the device comprising in its interior a vial (2) with the colorimetric detection reagents (3) for the detection of the vaginal pathogen coated by an absorbent encapsulation (1). Also shown in the figure is the withdrawal element (4) composed of a wire connected to the device.
La figura 2 muestra una vista frontal externa de una realización preferida del dispositivo que comprende una envoltura (5), que da soporte y protege los elementos del dispositivo, unida al aplicador extensible (6) que comprende en su interior el elemento perforador (7). Figure 2 shows an external front view of a preferred embodiment of the device comprising a wrapper (5), which supports and protects the elements of the device, attached to the extensible applicator (6) which comprises in its interior the piercing element (7) .
La figura 3 muestra una vista en detalle del interior del vial (2) que comprende los reactivos de detección colorimétrica (3) en una realización preferida del dispositivo. La figura 3 muestra el momento de ruptura del vial mediante el elemento perforador (7) y la liberación de los reactivos de detección colorimétrica. Figure 3 shows a detailed view of the inside of the vial (2) comprising the colorimetric detection reagents (3) in a preferred embodiment of the device. Figure 3 shows the moment of rupture of the vial by means of the piercing element (7) and the release of the colorimetric detection reagents.
La figura 4 muestra una vista de una realización preferida del empaquetamiento del dispositivo que comprende una caja (8) que comprende insertado el dispositivo (9) y una banda colorimétrica (10) indicadora de los valores y diagnóstico de la prueba. Figure 4 shows a view of a preferred embodiment of the packaging of the device comprising a box (8) comprising the device (9) inserted and a colorimetric band (10) indicating the values and diagnosis of the test.

Claims

REIVINDICACIONES
1 . Un dispositivo para la detección de enfermedades vaginales que comprende: one . A device for the detection of vaginal diseases comprising:
una envoltura,  a wrap,
un vial que comprende al menos un reactivo de detección colorimétrica frente a un patógeno vaginal, donde el vial está situado en el interior de la envoltura,  a vial comprising at least one colorimetric detection reagent against a vaginal pathogen, where the vial is located inside the envelope,
un encapsulado absorbente que recubre el vial, donde el encapsulado absorbente está situado en el interior de la envoltura, al menos un elemento perforador situado en el interior de la envoltura,  an absorbent encapsulation covering the vial, where the absorbent encapsulation is located inside the wrapper, at least one perforating element located inside the wrapper,
al menos un aplicador dispuesto junto al elemento perforador en el interior de la envoltura, y  at least one applicator disposed next to the piercing element inside the envelope, and
un elemento de retirada del dispositivo conectado a la envoltura, donde el elemento perforador se desliza por el interior de la envoltura y rompe el vial permitiendo la dispersión de los reactivos de detección colorimétrica a través del encapsulado absorbente, donde dicho encapsulado absorbente cambia de color en presencia de un patógeno vaginal.  a withdrawal element of the device connected to the envelope, where the perforating element slides inside the envelope and breaks the vial allowing the dispersion of the colorimetric detection reagents through the absorbent encapsulation, where said absorbent encapsulation changes color in presence of a vaginal pathogen.
2. El dispositivo según la reivindicación 1 que además comprende un sensor de detección de un parámetro biológico que se selecciona de la lista que consiste en: pH, flora vaginal no patogénica, ácido succínico, ácido butírico, ácido acético y ácido láctico. 2. The device according to claim 1 further comprising a sensor for detecting a biological parameter that is selected from the list consisting of: pH, non-pathogenic vaginal flora, succinic acid, butyric acid, acetic acid and lactic acid.
3. El dispositivo según la reivindicación 2 en donde el sensor de detección de un parámetro biológico es un sensor eléctrico. 3. The device according to claim 2 wherein the detection sensor of a biological parameter is an electrical sensor.
4. El dispositivo según una cualquiera de las reivindicaciones 1 a 3 que además comprende un módulo de transmisión inalámbrica de datos. 4. The device according to any one of claims 1 to 3 further comprising a wireless data transmission module.
5. El dispositivo según la reivindicación 4 en donde el módulo de transmisión inalámbrica de datos está conectado al sensor de detección de un parámetro biológico. 5. The device according to claim 4 wherein the wireless data transmission module is connected to the detection sensor of a biological parameter.
6. El dispositivo según una cualquiera de las reivindicaciones 1 a 5 en donde el encapsulado absorbente es de un material hipoalergénico natural y/o sintético. 6. The device according to any one of claims 1 to 5 wherein the absorbent encapsulation is of a natural and / or synthetic hypoallergenic material.
7. El dispositivo según la reivindicación 6 en donde el material hipoalergénico se selecciona de la lista que consiste en: algodón, lana, viscosa, seda, fibra de polipropileno, fibra de poliéster y cualquier combinación de los mismos. 7. The device according to claim 6 wherein the hypoallergenic material is selected from the list consisting of: cotton, wool, viscose, silk, polypropylene fiber, polyester fiber and any combination thereof.
8. El dispositivo según una cualquiera de las reivindicaciones 1 a 7 en donde el aplicador es extensible. 8. The device according to any one of claims 1 to 7 wherein the applicator is extensible.
9. El dispositivo según una cualquiera de las reivindicaciones 1 a 8 en donde elemento de retirada del dispositivo es un hilo, preferiblemente un hilo hipoalergénico. 9. The device according to any one of claims 1 to 8 wherein the device withdrawal element is a thread, preferably a hypoallergenic thread.
10. El dispositivo según una cualquiera de las reivindicaciones 1 a 9 en donde el patógeno vaginal se selecciona de la lista que consiste en: virus papiloma humano, clamidia, cándida, micoplasma, virus herpes simple, estreptococos y gardnerella. 10. The device according to any one of claims 1 to 9 wherein the vaginal pathogen is selected from the list consisting of: human papillomavirus, chlamydia, candida, mycoplasma, herpes simplex virus, streptococci and gardnerella.
1 1. El dispositivo según la reivindicación 10 en donde el patógeno vaginal es el virus del papiloma humano. 1 1. The device according to claim 10 wherein the vaginal pathogen is the human papillomavirus.
12. El dispositivo según una cualquiera de las reivindicaciones 1 a 1 1 en donde el dispositivo además comprende un reactivo de detección de embarazo. 12. The device according to any one of claims 1 to 1 1 wherein the device further comprises a pregnancy detection reagent.
13. El dispositivo según una cualquiera de las reivindicaciones 1 a 12 en donde el dispositivo además comprende un elemento de valoración colorimétrica del color del encapsulado absorbente en presencia de un patógeno vaginal o de un embarazo. 13. The device according to any one of claims 1 to 12 wherein the device further comprises an element for colorimetric assessment of the color of the absorbent encapsulation in the presence of a vaginal pathogen or a pregnancy.
PCT/IB2019/061324 2019-12-24 2019-12-24 Device for the detection of vaginal diseases WO2020039420A2 (en)

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US4424054A (en) * 1978-05-17 1984-01-03 Kcdp Corporation Fluid-expansible contraceptive tampon and applicator
US4788985A (en) * 1982-09-30 1988-12-06 Medtest Corporation Device for cell sampling in a body cavity
US4633886A (en) * 1985-05-02 1987-01-06 Bucaro Jr Russell J Device for home detection of cervical and vaginal cancer
US6117090A (en) * 1994-08-25 2000-09-12 Caillouette; James C. Method and apparatus for detecting amine producing organisms in the vagina
FR2726992B1 (en) * 1994-11-21 1997-06-27 Sgro Jean Claude DEVICE FOR THE SAMPLING AND ANALYSIS OF BIOLOGICAL LIQUIDS
US5769813A (en) * 1995-06-07 1998-06-23 Peiler; Frances K. Indicator tampon applicator
CA2307420A1 (en) * 1999-09-23 2001-03-23 Cleveland Blythe Vaginal probe having an improved sensor and method of using same
US7577476B2 (en) * 2001-10-26 2009-08-18 Athena Feminine Technologies, Inc System and method for transducing, sensing, or affecting vaginal or body conditions, and/or stimulating perineal musculature and nerves using 2-way wireless communications

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