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WO2009072856A1 - Speculum vaginal équipé d'un système et procédé spécifique de diagnostic des lésions produites par le virus du papillome humain dans le tractus génital féminin - Google Patents

Speculum vaginal équipé d'un système et procédé spécifique de diagnostic des lésions produites par le virus du papillome humain dans le tractus génital féminin Download PDF

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Publication number
WO2009072856A1
WO2009072856A1 PCT/MX2007/000147 MX2007000147W WO2009072856A1 WO 2009072856 A1 WO2009072856 A1 WO 2009072856A1 MX 2007000147 W MX2007000147 W MX 2007000147W WO 2009072856 A1 WO2009072856 A1 WO 2009072856A1
Authority
WO
WIPO (PCT)
Prior art keywords
diagnosis
human papillomavirus
genital tract
speculum
female genital
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/MX2007/000147
Other languages
English (en)
Spanish (es)
Inventor
Joel Gerardo DÍAZ SÁNCHEZ
José Gerardo Zertuche Zuani
Cala Hegde
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to PCT/MX2007/000147 priority Critical patent/WO2009072856A1/fr
Publication of WO2009072856A1 publication Critical patent/WO2009072856A1/fr
Priority to MX2010005609A priority patent/MX2010005609A/es
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/303—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the vagina, i.e. vaginoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00163—Optical arrangements
    • A61B1/00186—Optical arrangements with imaging filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/043—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances for fluorescence imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/0661—Endoscope light sources
    • A61B1/0684—Endoscope light sources using light emitting diodes [LED]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/32—Devices for opening or enlarging the visual field, e.g. of a tube of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters

Definitions

  • Vaginal speculum with a specific system and method for the diagnosis of lesions caused by the Human Papillomavirus in the female genital tract.
  • the viral genus Papilloma is too extensive, they are DNA viruses that infect many species of animals, including Man. There are more than 100 types of these known as Human Papillomavirus (HPV).
  • HPV Human Papillomavirus
  • Cervical Cancer Uterine is a common class of cancer in women, it is a change of the cells of the epithelial tissue of the cervix, as well as the vaginal and vulvar walls. These cells are initially normal and gradually become precancerous. Before cancer cells are found in the cervix, their tissues undergo changes and abnormal cells begin to appear; Process known as Dysplasia or Cervical Intraepithelial Neoplasia (NIC).
  • Dysplasia or Cervical Intraepithelial Neoplasia (NIC).
  • HPV HPV-like virus
  • Cervical-Uterine Cancer is one of the most common cancers in women. The figure of 500,000 cases per year is estimated worldwide. About 80% of these occur in developing countries. The high incidence of cases reflects the poverty of massive cervical cancer screening programs (CaCu), as well as low-cost medical equipment and methods that facilitate early detection of the disease even in the most distant locations of the populations .
  • CaCu massive cervical cancer screening programs
  • vaginal speculum is one of the most used medical instruments. Every year millions of vaginal exams are performed worldwide. The name of the instrument used in any gynecological examination is: Vaginal speculum. This was invented many centuries ago, in the Talmud and in ancient documents from India dated 3,000 years ago, there are already descriptions of it. It was the Hebrews who introduced the use of the speculum to vaginally examine women suffering from female genital tract problems. Such an apparatus consisted of a mobile cylinder contained in a lead tube. The ancient Greeks and Romans had a speculum with vanes that could be separated by turning a nut, which they called: "diopter", derived from the Greek word "dioptra” which means spying or scrutinizing. The speculum arrived in Europe through Arab medicine while maintaining the form and name of the Roman diopter.
  • vaginal speculums The most commonly used vaginal speculums are Graves and Pederson's, disposable or sterilizable.
  • speculacopy The technique used for observation through the correct handling of the speculum is called speculacopy, which consists of its introduction into the vagina to observe the vaginal wall and the cervix. Speculoscopy is considered within gynecology as a direct visualization inspection method.
  • the cervix or Portio is the horizon of the examination with the speculum and that is where the signs of the injuries caused by the Human Papillomavirus (HPV) can be found, which have been increasing in the population during the last 15 years, so It is called as an emerging disease.
  • HPV Human Papillomavirus
  • speculoscopy refers to the method of visual inspection of the cervix using the acetic acid test and illuminating with bright white chemiluminescent light. This technique is currently only considered for research purposes and is not attached to massive cervical cancer screening programs (CaCu).
  • cervical-uterine cancer is common among woman's cancers; a figure of 500,000 cases per year is estimated worldwide, but about 80% occur in developing countries, of which about 200,000 to 250,000 women die.
  • Cervical-uterine cancer begins with changes in the cells of the epithelial tissue of the cervix, which gradually become abnormal cells called coilocytes and dyskeratocytes, which are typed at a microscopic level by a different Pap smear due to the presence of keratin and cell nuclei with increasing size; Its presence is an indicator of infection caused by HPV and is known by the term cervical intraepithelial dysplasia or neoplasia (CIN).
  • CIN cervical intraepithelial dysplasia or neoplasia
  • vaginal speculum Graves, Pederson, Collin, Seyffert and Cusco, Trélat etc., disposable or sterilizable and its fluorescence excitation system using the Light Emitting Diode (LED) of Gallium Nitrogen for the diagnosis of lesions caused by the Virus of the Human papilloma in the female genital tract presented in the present invention aims, in addition to the above, to reduce medical costs and increase the benefit in the management of the patient.
  • LED Light Emitting Diode
  • the weight of the equipment is not more than 250 grams, which allows us to take it anywhere.
  • the rechargeable battery holder contains connection adapters for 120-220 volts. 6.- The selection of the easy-to-use barrier filter in the system accepts the fluorescence technique with the specific fluorochrome for live tissues, so it allows the detection of the fluorochrome inside the diseased tissue in a single scan.
  • the system can be used with both Graves, Pederson, or other sterilizable or disposable specula.
  • the electrical cable chosen for the illuminator is hermetically sealed, which allows its sterilization.
  • the invention relates to a combination of a vaginal speculum (Serious or Pederson, etc., sterilizable or disposable) (Figure 1) with an excitation system for fluorescence by means of a high power illuminator (Figure 1-A), with an Emitting Diode of Light (LED) of Nitrogen Gallium (Figure 1-J) with which we can perform the excitation in the diseased cervix and produce the phenomenon of fluorescence by blue light using fluorochrome or Fluorescein Isothiocyanate dye as a marker of HPV-infected tissue Likewise, in order to visualize this image, the speculum contains a "Long Pass Band” barrier filter or a yellow cut ( Figures 1-K and 2- D).
  • Electromagnetic Spectrum The world around us is full of waves, for some of them we can see or hear, but most of these, our senses cannot detect them.
  • atoms and molecules are made up of electrons, protons, mesons, photons etc., which move undulatingly forming waves in their bonds. Appropriately stimulated, these atoms and molecules emit waves that we call: gamma rays, x-rays, ultraviolet waves, visible waves, television, radio, infrared radiation, etc. This is known as: Electromagnetic Spectrum.
  • the waves are described by their amplitude (peak to peak), frequency (Hz) and length (length size) called Lambda ( ⁇ ).
  • the visible spectrum goes from deep red with 700 nm, to violet with 400 nm.
  • luminescence is the optical radiation of a physical system produced during transfer of an excited condition to a basic condition.
  • the light (or photonic energy) emitted is triggered by frequency energy in the x-ray, ultraviolet, infrared or visible spectrum.
  • the luminescence can be divided into 2 phenomena: phosphorescence and fluorescence. In phosphorescence the body continues to emit light after being excited.
  • Fluorescence is the property of certain chemical substances to absorb short waves of light energy and simultaneously produce long wavelengths.
  • Ultraviolet light (short energy) (Figure 3 -A) is absorbed first by the substance and it excites electrons in their orbits ( Figures 3-B and 3-C) by passing them to longer orbit spins emitting with this change of light of greater wavelength that affects the visible spectrum ( Figure 3 -D), then the electrons return to their site, extinguishing with this the radiation of light of greater wavelength, this law is known as "Law of Stokes-Adams "( Figure 3).
  • fluorochrome is applied by our technique in the cervix, and it is absorbed by the cells of tissues infected by the Human Papillomavirus.
  • the blue light beam emitted by the Light Emitting Diode (LED) affects the fluorochrome inside the cells, and infected tissues. This light energy is absorbed by it in the tissues, and then the fluorochrome itself emits light at different wavelengths of the light with which it was irradiated.
  • the physical phenomenon of fluorescence occurs: The tissue cells fluoresce.
  • the energy of the light irradiated by the Nitrogen Gallium LED at a blue excitation is absorbed by the FITC fluorescein isothiocyanate inside the infected cells exciting their electrons, changing spins and producing the emission of photons.
  • the photon is produced in the change of the electron in its spin, with this physical phenomenon new photons are emitted in a wavelength greater than blue, which is different than the wavelength with which the tissues and cells were originally irradiated.
  • Band Pass Filter “band or cut-off filter” that allows the passage of a yellow and green wavelength, the purpose of these is let frequencies greater than 520 nm pass to be seen, thus infected cells and tissues.
  • Fluorescence is the basis of many modern methods within the Life Sciences that at this time has its greatest objective in molecular and cellular biology, immunology, virology and oncology.
  • vaginal speculum with an excitation system for fluorescence by means of the Light Emitting Diode (LED) of Nitrogen Gallium and the fluorochrome Isothiocyanate Fluorescein (FITC) for the diagnosis of diseases caused by the Human Papillomavirus in the genital tract Feminine is composed of several parts that structure the system:
  • the vaginal speculum consists of two leaflets or leaves in the form of a "duck's beak" ( Figure 1-B) that are insertable in the vagina and that when opened with smooth movements, the vaginal walls can be visualized.
  • the speculum also has a handle ( Figure 1-C) with which it allows us to perform the location of the uterine cervix with different movements, positioning the speculum in a way that does not produce a feeling of discomfort in the patient. Once in correct position, this can be fixed with its respective adjustment knob (Figure 1-E), as well as with the leaflet safety (Figure 1-D).
  • the speculum has two entries to remove and put, the one located in the handle allows us to fix the illuminator ( Figures 1-F and 4-B) and the second located in the upper leaflet allows us to put the barrier filter holder ( Figures 1-G and 2-A).
  • the illuminator contains the Light Emitting Diode (LED) of Gallium Nitrogen that provides the light to the speculum, this LED is characterized by its brilliance in the light, with hospital-grade electric cable, which allows us to sterilize it.
  • LED Light Emitting Diode
  • the illuminator ( Figures 1-A and 4- A) consisting of a Light Emitting Diode (LED) of Nitrogen Gallium with a blue spectrum, is placed in the distal part of the illuminator and is located in the speculum ( Figures 1-J and 4-D).
  • LED Light Emitting Diode
  • the barrier filter holder ( Figures 1-K and 2) is inserted into the posterior lip of the upper leaflet of the speculum by means of a pressure clip ( Figures 1-G and 2-A).
  • the filter holder is annular with 2 rings that allow the barrier filter to be accommodated easily (Figure 2-D), the filter is housed between these two rings ( Figures 2-B and 2-C).
  • the illuminator is easily installed in the speculum handle by means of the "U" adapter that is fixed in the speculum handle ( Figures 1-1 and 4-B). In the same way as the filter holder, it is inserted into the speculum in the upper leaflet by means of a clamping clip ( Figure 4-C).
  • the Nitrogen Gallium LED is powered by a bipolar electrical cable that comes from a low-voltage direct current source ( Figures 1-H and 4-E).
  • the power supply consists of a battery, it can be rechargeable by an electronic system that allows recharging in 120-220 volts AC lines.
  • the power switch is located in the electric cable, commonly called passage, which facilitates its maneuverability by the doctor when performing the scan Technique
  • Fluorescein Fluorochrome Isothiocyanate FITC
  • Procedure • Comfortably place the patient in a gynecological position.
  • the duration of the study is approximately 10 minutes.
  • NIC Intraepithelial Cervical Neoplasms
  • FITC fluorochrome

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Optics & Photonics (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Microelectronics & Electronic Packaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)

Abstract

L'incidence élevée de cas de cancer cervico-utérin reflète les limites des programmes massifs de détection, ainsi que des équipements et des procédés médicaux de faible coût facilitant la détection précoce de la maladie, y compris dans les populations les plus retirées, objet de la présente invención. L'invention concerne un nouveau système de spéculoscopie diagnostique de très faible coût pour la détection des lésions causées par le virus du papillome humain (VPH) dans le tractus génital féminin. Le poids de cet équipement est d'à peine 200 grammes. La nouvelle invention combine un speculum vaginal et un système de fluorescence spécifique pour le marqueur des lésions produites par le VPH. Ce système comprend une diode électroluminescente (DEL) de gallium d'azote émettant une lumière bleue requise pour l'excitation du marqueur dans l'épithélium malade, l'image des lésions pouvant être observée à travers un filtre de suppression jaune. La source d'alimentation en électricité pour l'alimentation du dispositif d'éclairage est une batterie rechargeable de longue durée, ce qui permet d'utiliser ledit équipement dans n'importe quel endroit du monde.
PCT/MX2007/000147 2007-12-04 2007-12-04 Speculum vaginal équipé d'un système et procédé spécifique de diagnostic des lésions produites par le virus du papillome humain dans le tractus génital féminin Ceased WO2009072856A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/MX2007/000147 WO2009072856A1 (fr) 2007-12-04 2007-12-04 Speculum vaginal équipé d'un système et procédé spécifique de diagnostic des lésions produites par le virus du papillome humain dans le tractus génital féminin
MX2010005609A MX2010005609A (es) 2007-12-04 2010-05-21 Especulo vaginal con un sistema y metodo especifico para el diagnostico de lesiones producidas por el virus del papiloma humano en el tracto genital femenino.

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/MX2007/000147 WO2009072856A1 (fr) 2007-12-04 2007-12-04 Speculum vaginal équipé d'un système et procédé spécifique de diagnostic des lésions produites par le virus du papillome humain dans le tractus génital féminin

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WO2009072856A1 true WO2009072856A1 (fr) 2009-06-11

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PCT/MX2007/000147 Ceased WO2009072856A1 (fr) 2007-12-04 2007-12-04 Speculum vaginal équipé d'un système et procédé spécifique de diagnostic des lésions produites par le virus du papillome humain dans le tractus génital féminin

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Country Link
WO (1) WO2009072856A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102578997A (zh) * 2012-03-08 2012-07-18 夏荣 一种家用妇科阴道自检和情趣一体装置
CN102934985A (zh) * 2012-10-29 2013-02-20 上海商联医疗器械有限公司 窥阴射光固定器
GB2500241A (en) * 2012-03-15 2013-09-18 Evexar Medical Ltd Speculum with mounting unit
WO2014022792A1 (fr) * 2012-08-03 2014-02-06 Mm Optics, Ltda. Dispositif de diagnostic, dispositif thérapeutique, et leurs utilisations
CN105708410A (zh) * 2016-01-20 2016-06-29 广州普露医疗科技有限公司 阴道子宫颈检治仪

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5251613A (en) * 1991-05-06 1993-10-12 Adair Edwin Lloyd Method of cervical videoscope with detachable camera
WO2004040314A1 (fr) * 2002-10-31 2004-05-13 Chemometec A/S Procede d'evaluation de particules
WO2005039403A1 (fr) * 2003-10-27 2005-05-06 Joel Gerardo Diaz Sanchez Detection specifique de lesions produites par le virus du papillome humain dans le tractus genital feminin inferieur
US20060215406A1 (en) * 2005-02-18 2006-09-28 William Thrailkill Medical diagnostic instrument with highly efficient, tunable light emitting diode light source
WO2006107877A2 (fr) * 2005-04-01 2006-10-12 Welch Allyn, Inc. Speculum vaginal
WO2006105654A1 (fr) * 2005-04-08 2006-10-12 Led Medical Diagnostics, Inc. Speculums substantiellement non fluorescents et méthodes qui s’y rattachent
WO2007043020A2 (fr) * 2005-10-13 2007-04-19 United Medical Partners Ag Lampe portable integree destinee a etre fixee sur un speculum

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5251613A (en) * 1991-05-06 1993-10-12 Adair Edwin Lloyd Method of cervical videoscope with detachable camera
WO2004040314A1 (fr) * 2002-10-31 2004-05-13 Chemometec A/S Procede d'evaluation de particules
WO2005039403A1 (fr) * 2003-10-27 2005-05-06 Joel Gerardo Diaz Sanchez Detection specifique de lesions produites par le virus du papillome humain dans le tractus genital feminin inferieur
US20060215406A1 (en) * 2005-02-18 2006-09-28 William Thrailkill Medical diagnostic instrument with highly efficient, tunable light emitting diode light source
WO2006107877A2 (fr) * 2005-04-01 2006-10-12 Welch Allyn, Inc. Speculum vaginal
WO2006105654A1 (fr) * 2005-04-08 2006-10-12 Led Medical Diagnostics, Inc. Speculums substantiellement non fluorescents et méthodes qui s’y rattachent
WO2007043020A2 (fr) * 2005-10-13 2007-04-19 United Medical Partners Ag Lampe portable integree destinee a etre fixee sur un speculum

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102578997A (zh) * 2012-03-08 2012-07-18 夏荣 一种家用妇科阴道自检和情趣一体装置
GB2500241A (en) * 2012-03-15 2013-09-18 Evexar Medical Ltd Speculum with mounting unit
GB2500241B (en) * 2012-03-15 2018-04-18 Griffiths & Nielsen Ltd Medical device
WO2014022792A1 (fr) * 2012-08-03 2014-02-06 Mm Optics, Ltda. Dispositif de diagnostic, dispositif thérapeutique, et leurs utilisations
US9550072B2 (en) 2012-08-03 2017-01-24 Cerca Solutions, LLC Diagnostic device, therapeutic device, and uses thereof
TWI657801B (zh) * 2012-08-03 2019-05-01 美商塞卡解答公司 光診斷裝置
CN102934985A (zh) * 2012-10-29 2013-02-20 上海商联医疗器械有限公司 窥阴射光固定器
CN105708410A (zh) * 2016-01-20 2016-06-29 广州普露医疗科技有限公司 阴道子宫颈检治仪

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