WO2020039420A2 - Dispositif pour la détection de maladies vaginales - Google Patents

Dispositif pour la détection de maladies vaginales 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
Authority
WO
WIPO (PCT)
Prior art keywords
vaginal
vial
detection
absorbent
pathogen
Prior art date
Application number
PCT/IB2019/061324
Other languages
English (en)
Spanish (es)
Other versions
WO2020039420A3 (fr
Inventor
Alice Mathilde Jeanine MONCORGER
Cecilia CEMPINI
Paola Ximena DALGO AGUILAR
Roberto Carlos CUENCA JIMENEZ
Original Assignee
Universidad Técnica Particular De Loja
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Universidad Técnica Particular De Loja filed Critical Universidad Técnica Particular De Loja
Priority to PCT/IB2019/061324 priority Critical patent/WO2020039420A2/fr
Publication of WO2020039420A2 publication Critical patent/WO2020039420A2/fr
Publication of WO2020039420A3 publication Critical patent/WO2020039420A3/fr

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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
    • A61B10/02—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.

Landscapes

  • 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

La présente invention porte sur un dispositif à usage domestique pour diagnostiquer des maladies vaginales. Le dispositif est constitué d'un flacon qui comprend des réactifs colorimétriques qui réagissent à des agents pathogènes, lequel flacon est encapsulé par une protection absorbante, conjointement à un applicateur. L'applicateur comprend un élément perforateur qui permet de briser le flacon qui, en présence d'agents pathogènes, produit un changement de couleur de l'encapsulage absorbant, indiquant à l'utilisateur le diagnostic clinique.
PCT/IB2019/061324 2019-12-24 2019-12-24 Dispositif pour la détection de maladies vaginales WO2020039420A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2019/061324 WO2020039420A2 (fr) 2019-12-24 2019-12-24 Dispositif pour la détection de maladies vaginales

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2019/061324 WO2020039420A2 (fr) 2019-12-24 2019-12-24 Dispositif pour la détection de maladies vaginales

Publications (2)

Publication Number Publication Date
WO2020039420A2 true WO2020039420A2 (fr) 2020-02-27
WO2020039420A3 WO2020039420A3 (fr) 2020-10-08

Family

ID=69592709

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2019/061324 WO2020039420A2 (fr) 2019-12-24 2019-12-24 Dispositif pour la détection de maladies vaginales

Country Status (1)

Country Link
WO (1) WO2020039420A2 (fr)

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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 (fr) * 1994-11-21 1997-06-27 Sgro Jean Claude Dispositif pour le prelevement et l'analyse de liquides biologiques
US5769813A (en) * 1995-06-07 1998-06-23 Peiler; Frances K. Indicator tampon applicator
CA2307420A1 (fr) * 1999-09-23 2001-03-23 Cleveland Blythe Sonde vaginale munie d'un detecteur ameliore, ainsi que sa methode d'utilisation
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

Also Published As

Publication number Publication date
WO2020039420A3 (fr) 2020-10-08

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