WO2009072856A1 - Vaginal speculum including a system and a specific method for diagnosing lesions caused by the human papillomavirus in the female genital tract - Google Patents

Vaginal speculum including a system and a specific method for diagnosing lesions caused by the human papillomavirus in the female genital tract 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
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WIPO (PCT)
Prior art keywords
diagnosis
human papillomavirus
genital tract
speculum
female genital
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PCT/MX2007/000147
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Spanish (es)
French (fr)
Inventor
Joel Gerardo DÍAZ SÁNCHEZ
José Gerardo Zertuche Zuani
Cala Hegde
Original Assignee
Diaz Sanchez Joel Gerardo
Zertuche Zuani Jose Gerardo
Cala Hegde
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Application filed by Diaz Sanchez Joel Gerardo, Zertuche Zuani Jose Gerardo, Cala Hegde filed Critical Diaz Sanchez Joel Gerardo
Priority to PCT/MX2007/000147 priority Critical patent/WO2009072856A1/en
Publication of WO2009072856A1 publication Critical patent/WO2009072856A1/en
Priority to MX2010005609A priority patent/MX2010005609A/en

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    • 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

Abstract

The high incidence of cases of cervical-uterine cancer reflects the lack of mass detection programmes and of low-cost medical methods and equipment that facilitate early detection of the disease even among the most remote populations. The invention relates to a very-low-cost novel diagnostic speculoscopy system for the detection of lesions caused by human papillomavirus (HPV) in the female genital tract. Said device weighs barely 200 grams. The novel invention combines a vaginal speculum with a fluorescence system specific to the marker of lesions caused by HPV. Said system contains a nitrogen gallium light-emitting diode (LED) that emits the blue light required to excite the marker in the diseased epithelium, the image of the lesions being observed with a yellow barrier filter. The electricity supply source used to power the illuminator is a long-life rechargeable battery, which enables the device to be used anywhere in the world.

Description

Espéculo vaginal con un sistema y método específico para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino. Vaginal speculum with a specific system and method for the diagnosis of lesions caused by the Human Papillomavirus in the female genital tract.
Sector técnico: Instrumentos médicos ópticos y opto-electrónicos, instrumentos y métodos ginecológicos para diagnóstico de lesiones producidas por el Virus del Papiloma Humano (VPH) en el tracto genital femenino mediante métodos visuales. Tecnologías emergentes en displasias, Óptica y Física Médica.Technical sector: Optical and opto-electronic medical instruments, gynecological instruments and methods for diagnosing lesions caused by Human Papillomavirus (HPV) in the female genital tract through visual methods. Emerging technologies in dysplasias, Optics and Medical Physics.
Antecedentes de Ia invención:Background of the invention:
El género viral Papilloma es demasiado extenso, son virus de DNA que infectan muchas especies de animales, incluyendo al Hombre. Existen más de 100 tipos de éstos conocidos como Virus del Papiloma Humano (VPH).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).
El interés por estos virus ha ido en aumento gradualmente a partir de 1970, cuando por primera vez se les atribuyó una función en la etiología del Cáncer Cérvico Uterino (CaCu).Interest in these viruses has gradually increased since 1970, when they were first assigned a role in the etiology of Cervical Cancer (CaCu).
El Cáncer Cérvico Uterino es una clase común de cáncer en la mujer, es un cambio de las células del tejido epitelial del cérvix, así como de las paredes vaginales y vulva. Estas células son inicialmente normales y gradualmente se convierten precancerosas. Antes de que se encuentren células cancerosas en el cérvix, sus tejidos experimentan cambios y empiezan a aparecer células anormales; Proceso conocido como Displasia o Neoplasia Intraepitelial Cervical (NIC).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).
Existen más de 30 tipos virales del VPH, que tienen la habilidad de infectar el tracto genital femenino, de estos tipos hay virus benignos llamados de "bajo riesgo", y otros oncogénicos llamados de "alto riesgo".There are more than 30 viral types of HPV, which have the ability to infect the female genital tract, of these types there are benign viruses called "low risk", and other oncogenic called "high risk".
El Cáncer Cérvico-Uterino es uno de los más comunes cánceres en la mujer. Se estima la cifra de 500,000 casos por año a escala mundial. Cerca del 80% de estos se presentan en los países en desarrollo. La alta incidencia de casos refleja la pobreza de los programas masivos de detección de cáncer cérvico-uterino (CaCu), así como de equipos y métodos médicos de bajo costo que faciliten la detección temprana de la enfermedad aún en los lugares más distantes de las poblaciones.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 .
El espéculo vaginal es uno de los instrumentos médicos más utilizados. Cada año se realiza en todo el mundo millones de exploraciones vaginales. El nombre del instrumento que se utiliza en toda exploración ginecológica es: Espéculo Vaginal. Este fue inventado hace muchos siglos, en el Talmud y en documentos antiguos procedentes de la India fechados hace 3,000 años, ya existen descripciones de éste. Fueron los Hebreos quienes introdujeron el uso del espéculo para examinar vaginalmente a las mujeres que padecían problemas del tracto genital femenino. Tal aparato consistía en un cilindro móvil contenido en un tubo de plomo. Los antiguos griegos y romanos dispusieron de un espéculo con paletas que podían separarse girando una tuerca, al que llamaban: "dióptero", derivado de la palabra griega "dioptra" que significa espiar o escrutar. El espéculo llegó a Europa a través de la medicina árabe manteniendo la forma y el nombre del dióptero romano.The 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.
En el siglo XVIII comenzó a llamársele espéculo quizás por tener que ver con el hecho de que la luz entra en la vagina mediante un espejo o posiblemente a las propiedades del metal empleado.In the eighteenth century it began to be called speculum perhaps because it has to do with the fact that light enters the vagina through a mirror or possibly the properties of the metal used.
Los espéculos vaginales más comúnmente usados hoy en día son los de Graves y de Pederson, desechables o esterilizables.The most commonly used vaginal speculums are Graves and Pederson's, disposable or sterilizable.
La técnica usada para la observación mediante el correcto manejo del espéculo se llama especuloscopía que consiste en su introducción en la vagina para observar la pared vaginal y el cérvix. La especuloscopía es considerada dentro de la ginecología como un método de inspección de visualización directa.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.
El cérvix o Portio es el horizonte del examen con el espéculo y es ahí donde pueden encontrarse los signos de las lesiones producidas por el Virus del Papiloma Humano (VPH), mismas que han ido incrementándose en la población durante los últimos 15 años, por lo que se denomina como enfermedad emergente. Técnica Anterior: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. Previous Technique:
Existen 3 rutas importantes de avance para el diagnóstico de las enfermedades del tracto genital femenino: modificaciones a las técnicas citológicas, diversas pruebas de biología molecular y nuevos instrumentos médicos como: Tomografía de coherencia óptica, todas éstas con costos elevados.There are 3 important pathways for the diagnosis of female genital tract diseases: modifications to cytological techniques, various molecular biology tests and new medical instruments such as: Optical coherence tomography, all of which have high costs.
Estado Actual de la TécnicaCurrent State of the Art
En el estado actual de la técnica algunos autores mencionan que la especuloscopía se refiere al método de inspección visual del cérvix utilizando la prueba del ácido acético e iluminando con luz químicoluminiscente blanca brillante. Actualmente esta técnica está únicamente considerada para fines de investigación y no está adjuntada a programas masivos de detección de cáncer cérvico-uterino (CaCu).In the current state of the art, some authors mention that 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).
Otro autor oriundo de la India menciona en una revista mexicana que la especuloscopía mediante una luz brillante y la aplicación de vinagre en el cérvix uterino ha podido detectar las displasias en una zona de la India, sin embargo este estudio aún está en desarrollo.Another author from India mentions in a Mexican magazine that speculacopy using bright light and the application of vinegar in the uterine cervix has been able to detect dysplasia in an area of India, however this study is still under development.
Problemática:Issue:
El Papanicolaou desde la mitad del siglo pasado ha ayudado a prevenir el cáncer cérvico- uterino a nivel mundial, pero su confíabilidad no es la que sería de desearse.The Pap smear since the middle of the last century has helped prevent cervical cancer worldwide, but its reliability is not as desired.
Como se mencionó anteriormente el cáncer cérvico-uterino es común entre los cánceres de la mujer; se estima una cifra de 500,000 casos por año a escala mundial, pero cerca del 80% se presentan en los países en vías de desarrollo, de los que fallecen alrededor de 200,000 a 250,000 mujeres.As mentioned earlier 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.
En los Estados Unidos de Norteamérica la incidencia de CaCu por 100,000 mujeres está calculada en 8 y para Israel en 4.2, mientras que para Perú y México se dan cifras de 54.6 y 50 casos, respectivamente. Entre la mortalidad por neoplasias en la población femenina de México el cáncer cérvico-uterino ocupa la primera posición, con 12 a 16 fallecimientos al día, pues en el año 2000 fueron registradas 4,604 defunciones según la Secretaría de Salud.In the United States, the incidence of CaCu per 100,000 women is estimated at 8 and for Israel at 4.2, while for Peru and Mexico there are figures of 54.6 and 50 cases, respectively. Among the mortality due to neoplasms in the female population of Mexico, cervical-uterine cancer occupies the first position, with 12 to 16 deaths per day, since in the year 2000 4,604 deaths were registered according to the Ministry of Health.
El cáncer cérvico-uterino inicia con cambios en las células del tejido epitelial del cérvix, que de manera gradual se van convirtiendo en células anormales llamadas coilocitos y disqueratocitos, que se tifien a nivel microscópico mediante el colorante de Papanicolaou diferente por la presencia de queratina y los núcleos celulares con aumento de tamaño; su presencia es indicador de infección producida por el VPH y se conoce con el término de displasia o neoplasia intraepitelial cervical (NIC).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).
El avance de la ciencia y tecnología desde el siglo pasado a la fecha en la enfermedad producida por el virus del papiloma humano han permitido disminuir la ventana epidemiológica (periodo entre el inicio de la presencia del agente etiológico y la aparición de la enfermedad), sin embargo actualmente la especuloscopía por sí sola no está situada para estudios masivos de la población debido a su baja sensibilidad y especificidad en el diagnóstico y en la detección temprana de displasias y cáncer cérvico-uterino.The advance of science and technology from the last century to date in the disease caused by the human papillomavirus has allowed the epidemiological window to decrease (period between the beginning of the presence of the etiologic agent and the appearance of the disease), without However, speculacopy alone is not currently located for massive population studies due to its low sensitivity and specificity in diagnosis and in the early detection of dysplasia and cervical-uterine cancer.
La falta en muchos consultorios y en los lugares mas remotos de un equipo óptimo, sencillo y barato así como pruebas sencillas para el diagnóstico de las displasias han hecho que los médicos recurran a las pruebas de laboratorio y el uso de recursos sofisticados con grandes demoras, en algunos casos, teniendo como consecuencia que el periodo de incertidumbre en la paciente afecte aún más su salud.The lack in many offices and in the most remote places of an optimal, simple and cheap equipment as well as simple tests for the diagnosis of dysplasias have made doctors resort to laboratory tests and the use of sophisticated resources with great delays, in some cases, resulting in the period of uncertainty in the patient affecting her health even more.
Solución al problema:Solution to the problem:
Por todo lo anteriormente mencionado acerca de que actualmente la especuloscopía por si sola no está situada para estudios masivos de la población por su baja sensibilidad, es por lo que hemos decidido combinar ésta con un sistema y un método específico para producir fluorescencia de alto poder en el tejido infectado por el VPH mediante el uso de un Diodo Emisor de Luz (siglas en ingles "LED") de Galio de Nitrógeno que emite luz azul ultra-brillante con longitud de onda exacta para excitar y producir fluorescencia en el fluorocromo marcador del tejido enfermo: Isotiocianato de fluoresceina (FITC). Para enviar esta luz directamente al cérvix o portio usamos un iluminador que se encuentra montado mediante un adaptador en el espéculo con la finalidad de producir el fenómeno de fluorescencia dentro del tejido celular enfermo en las lesiones del cérvix de acuerdo nuestro método y visualizando la imagen de este tejido mediante un filtro de supresión o barrera amarillo, obteniéndose ésta como una imagen rica de matices y contrastes sobre un fondo obscuro elevando de manera drástica la calidad de la imagen y teniendo un resultado altamente confiable. Es ideal su uso en los programas de control de salud reproductiva y también es un instrumento de uso rutinario para el consultorio del médico a nivel público o privado en el control de sus pacientes.For all the above mentioned that currently speculacopy alone is not located for mass studies of the population due to its low sensitivity, this is why we have decided to combine it with a specific system and method to produce high power fluorescence in HPV-infected tissue through the use of a Light Emitting Diode ("LED") of Nitrogen Gallium that emits ultra-bright blue light with exact wavelength to excite and produce fluorescence in the tissue fluorochrome marker patient: Fluorescein isothiocyanate (FITC). To send this light directly to the cervix or portio we use an illuminator that is mounted by means of an adapter in the speculum in order to produce the phenomenon of fluorescence within the diseased cell tissue in the lesions of the cervix according to our method and visualizing the image of this fabric by means of a suppression filter or yellow barrier, obtaining this as a rich image of shades and contrasts on a dark background, drastically raising the image quality and having a highly reliable result. It is ideal for use in reproductive health control programs and is also an instrument of routine use for the doctor's office at public or private level in the control of their patients.
El espéculo vaginal Graves, Pederson, Collin, Seyffert y Cusco, Trélat etc., desechable o esterilizable y su sistema de excitación de fluorescencia mediante el Diodo Emisor de Luz (LED) de Galio de Nitrógeno para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino presentado en la presente invención tiene por objeto, además de lo anteriormente descrito, reducir los costos médicos y aumentar el beneficio en el manejo de la paciente.The 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.
Ventajas de la invención:Advantages of the invention:
El sistema a patentar tiene características especiales y únicas así como ventajas competitivas:The system to be patented has special and unique characteristics as well as competitive advantages:
1.- Los sistemas de fluorescencia por lo general usan dos tipos de filtros, un excitador y un filtro barrera o de corte, el costo de un filtro de excitación es alto además de que requiere de una fuente de iluminación también costosa, con la introducción en este sistema de fluorescencia mediante un Diodo Emisor de Luz (LED) de Galio de Nitrógeno seleccionado a un espectro azul no requiere el sistema de un filtro excitador.1.- Fluorescence systems usually use two types of filters, an exciter and a barrier or cut filter, the cost of an excitation filter is high in addition to requiring an expensive lighting source, with the introduction In this fluorescence system using a Nitrogen Gallium Light Emitting Diode (LED) selected at a blue spectrum does not require the system of an exciter filter.
2.- El Diodo Emisor de Luz (LED) de Galio de Nitrógeno nos da la longitud de onda azul, brindándonos luz de alta calidad a un bajísimo costo.2.- The Nitrogen Gallium Light Emitting Diode (LED) gives us the blue wavelength, providing high quality light at a very low cost.
3.- El peso del equipo es no mayor a los 250 gramos lo que nos permite llevarlo a cualquier lugar.3.- The weight of the equipment is not more than 250 grams, which allows us to take it anywhere.
4.- El sistema funciona con batería recargable o bien con batería desechable.4.- The system works with rechargeable battery or disposable battery.
5.- El porta batería recargable contiene adaptadores de conexión para 120-220 voltios. 6.- La selección del filtro barrera de fácil uso en el sistema, acepta la técnica de fluorescencia con el fluorocromo específico para tejidos en vivo, así que permite la detección del fluorocromo dentro del tejido enfermo en una sola exploración.5.- 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.
7.- Nuestra técnica tiene como una de sus ventajas que el fluorocromo "isotiocianato de fluoresceína" es específico para reaccionar en la enfermedad producida por el virus del papiloma humano, al reaccionar y producir florescencia se ven las lesiones de ésta en fondo oscuro apareciendo las imágenes en colores llenos de matices, seleccionando lo que desea ver el observador, esto es el tejido lesionado por el VPH.7.- Our technique has as one of its advantages that the fluorochrome "fluorescein isothiocyanate" is specific to react in the disease caused by the human papillomavirus, when reacting and producing fluorescence the lesions of the latter are seen in dark background, appearing color images full of nuances, selecting what the observer wants to see, this is the tissue injured by HPV.
8.- Si se desea aumentar la imagen proveniente del espéculo se puede combinar con diferentes instrumentos como son: anteojos o lupas de aumentos, colposcopios, cámaras de video, cámaras digitales, detectores o cualquier analizador de imagen.8.- If you want to increase the image from the speculum, it can be combined with different instruments such as: magnifying glasses or magnifying glasses, colposcopes, video cameras, digital cameras, detectors or any image analyzer.
9.- El sistema puede ser usado tanto con espéculos de Graves, de Pederson, u otros esterilizables o desechables.9.- The system can be used with both Graves, Pederson, or other sterilizable or disposable specula.
10.- El cable eléctrico elegido para el iluminador está herméticamente sellado, lo que permite su esterilización.10.- The electrical cable chosen for the illuminator is hermetically sealed, which allows its sterilization.
11. -Esta técnica visual de selección mediante la especuloscopía podría ser empleada en los programas de detección temprana de las displasias del tracto genital femenino con inmediatos y buenos resultados en el mismo momento que el procedimiento es efectuado.11.-This visual technique of selection by speculacopy could be used in the early detection programs of dysplasia of the female genital tract with immediate and good results at the same time that the procedure is performed.
12.- Fuente de luz selectiva en su emisión de la banda para fluorescencia que requiere únicamente pocos minutos para el entrenamiento del personal médico y paramédico.12.- Selective light source in its emission of the fluorescence band that requires only a few minutes for the training of medical and paramedical personnel.
13.- Los resultados de la especuloscopía por fluorescencia son evaluados en el mismo momento de realizar el procedimiento y en el propio lugar donde se practique.13.- The results of fluorescence speculacopy are evaluated at the same time as the procedure and in the place where it is performed.
14.- El periodo de incertidumbre en la paciente se evita con este procedimiento ya que a la misma se le puede informar de inmediato la enfermedad que padece y qué tratamiento se seguirá.14.- The period of uncertainty in the patient is avoided with this procedure since it can be immediately informed of the disease and what treatment will be followed.
15.- Baja los costos en el manejo de los métodos y aumenta el beneficio para la población.15.- It lowers the costs in the handling of the methods and increases the benefit for the population.
Descripción técnica de Ia invención:Technical description of the invention:
Los detalles característicos de este novedoso sistema se muestran claramente en la siguiente descripción y en las figuras que le acompañan, así como una ilustración de aquella y siguiendo los mismos signos de referencia para indicar las partes de las figuras mostradas. La invención refiere una combinación de un espéculo vaginal (Graves o Pederson, etc., esterilizable o desechable) (Figura 1) con un sistema de excitación para fluorescencia mediante un iluminador de alto poder (Figura 1-A), con un Diodo Emisor de Luz (LED) de Galio de Nitrógeno (Figura 1-J) con el cual podemos realizar la excitación en el cérvix enfermo y producir el fenómeno de fluorescencia mediante luz azul usando el fluorocromo o colorante Isotiocianato de Fluoresceína como marcador del tejido infectado por el VPH, de igual manera para poder visualizar esta imagen el espéculo contiene un filtro barrera "Long Pass Band" o de corte color amarillo (Figuras 1-K y 2- D).The characteristic details of this new system are clearly shown in the following description and in the accompanying figures, as well as an illustration of it and following the same reference signs to indicate the parts of the figures shown. 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).
Con el propósito de describir plenamente este sistema ponemos en su conocimiento las siguientes definiciones y conocimientos básicos para describir el invento.In order to fully describe this system, we inform you of the following definitions and basic knowledge to describe the invention.
Energía luminosa-Luz:Light Energy-Light:
El mundo que nos rodea esta lleno de ondas, por algunas de ellas podemos ver u oír, pero la mayoría de estas, nuestros sentidos no las pueden detectar. En el mundo sub- microscópico, los átomos y moléculas están constituidos de electrones, protones, mesones, fotones etc., que se mueven ondulatoriamente formando ondas en sus enlaces. Apropiadamente estimulados, estos átomos y moléculas emiten ondas que llamamos: rayos gama, rayos equis, ondas ultravioleta, ondas visibles, televisión, radio, radiación infrarroja, etc. A esto se le conoce como: Espectro Electromagnético.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. In the sub-microscopic world, 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.
Las ondas son descritas por su amplitud (de cresta a cresta), frecuencia (Hz) y longitud (tamaño de largo) denominada Lambda (λ).The waves are described by their amplitude (peak to peak), frequency (Hz) and length (length size) called Lambda (λ).
En el espectro electromagnético, se denominan las ondas de luz de acuerdo a su longitud de onda, medida en nanómetros (nm), billonésimas del metro. Un nanómetro es: 10-9 metrosIn the electromagnetic spectrum, light waves are called according to their wavelength, measured in nanometers (nm), billionths of a meter. A nanometer is: 10- 9 meters
El Espectro visible, va del rojo profundo con 700 nm, al violeta con 400 nm.The visible spectrum, goes from deep red with 700 nm, to violet with 400 nm.
Existen diferentes tipos de filtros de luz, pues dejan pasar diferentes colores del espectro, con diferentes longitudes de onda, los hay verdes, azules, rojos, antitérmicos etc. pero no son exactos en escoger tan solo una longitud de onda, ya que para esto se requiere de filtros costosos, y fabricados especialmente con finalidades específicas.There are different types of light filters, because they let different colors of the spectrum pass, with different wavelengths, there are green, blue, red, anti-thermal etc. but no they are accurate in choosing just one wavelength, since this requires expensive filters, and specially manufactured for specific purposes.
Luminiscencia (Latín: lumen=luz) Es la habilidad que tiene un cuerpo para emitir luz cuando es excitado por una rúente de energía.Luminescence (Latin: lumen = light) It is the ability of a body to emit light when it is excited by a source of energy.
Científicamente hablando, luminiscencia es la radiación óptica de un sistema físico producida durante transferencia de una condición excitada a una condición básica. La luz (o energía fotónica) emitida es disparada por energía de frecuencia en el espectro de rayos x, ultravioleta, infrarrojo o visible.Scientifically speaking, 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.
La luminiscencia puede ser dividida en 2 fenómenos: fosforescencia y fluorescencia. En la fosforescencia el cuerpo continúa emitiendo luz después de ser excitado.The luminescence can be divided into 2 phenomena: phosphorescence and fluorescence. In phosphorescence the body continues to emit light after being excited.
El fenómeno de la fluorescencia ha sido observado por miles de años, este fenómeno ha sido mencionado en la literatura china desde hace 3,500 años.The phenomenon of fluorescence has been observed for thousands of years, this phenomenon has been mentioned in Chinese literature for 3,500 years.
En 1842 Sir George Gabriel Stokes (1819-1903) describió la luminiscencia observada en el mineral fluoruro de calcio y le llamó fluorescencia.In 1842 Sir George Gabriel Stokes (1819-1903) described the luminescence observed in the mineral calcium fluoride and called it fluorescence.
Fluorescencia es la propiedad de ciertas substancias químicas para absorber ondas cortas de energía luminosa y producir simultáneamente longitudes de onda largas. Ejemplo: Luz ultravioleta (corta energía) (Figura 3 -A) es absorbida primero por la sustancia y ésta excita a los electrones en sus órbitas (Figuras 3-B y 3-C) haciéndolos pasar a espines de órbita más largas emitiendo con este cambio luz de mayor longitud de onda que incide en el espectro visible (Figura 3 -D), entonces los electrones regresan a su sitio extinguiéndose con esto la radiación de luz de longitud de onda mayor, esta ley se conoce con el nombre de "Ley de Stokes- Adams "(Figura 3).Fluorescence is the property of certain chemical substances to absorb short waves of light energy and simultaneously produce long wavelengths. Example: 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).
Seguidamente se describe la excitación del fluorocromo en nuestro sistema:The fluorochrome excitation in our system is described below:
Primero, el fluorocromo es aplicado por nuestra técnica en el cérvix, y éste es absorbido por las células de los tejidos infectados por el Virus del Papiloma Humano. El haz de luz de color azul emitido por el Diodo Emisor de Luz (LED) incide en el fluorocromo dentro de las células, y tejidos infectados. Esta energía de luz es absorbida por éste en los tejidos, y entonces el fluorocromo por sí mismo emite luz en diferente longitud de onda de la luz con que fue irradiado. Se produce el fenómeno físico de fluorescencia: Las células del tejido fluorescen. La energía de la luz irradiada por el LED de Galio de Nitrógeno a una excitación color azul, es absorbida por el Isotiocianato de fluoresceina FITC dentro de las células infectadas excitando sus electrones, cambiando de espines y produciendo la emisión de fotones. El fotón es producido en el cambio del electrón en su espín, con este fenómeno físico nuevos fotones son emitidos en una longitud de onda mayor al azul, la cual es diferente que la longitud de onda con que fueron irradiados originalmente los tejidos y células.First, 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.
Para poder ver y localizar este fluorocromo en las células y tejidos lesionados se usa un filtro supresor: Band Pass Filter "filtro de paso de banda o de corte" que permite el paso de una longitud de onda amarilla y verde, la finalidad de éstos es dejar pasar una frecuencias mayores a 520 nm para ser vistas, así las células y tejidos infectados.To be able to see and locate this fluorochrome in the injured cells and tissues a suppressor filter is used: 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.
Hoy en día la Fluorescencia es la base de muchos métodos modernos dentro de las Ciencias de la Vida que en esta época tiene situado su mayor objetivo en la biología molecular y celular, inmunología, virología y oncología.Nowadays 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.
La combinación del espéculo vaginal con un sistema de excitación para fluorescencia mediante el Diodo Emisor de Luz (LED) de Galio de Nitrógeno y el fluorocromo Isotiocianato de Fluoresceina (FITC) para el diagnóstico de enfermedades producidas por el Virus del Papiloma Humano en el tracto genital femenino está integrada por varias partes que estructuran el sistema:The combination of the 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:
1.- El espéculo vaginal consiste en dos valvas u hojas en forma de "pico de pato" (Figura 1-B) mismas que son insertables en la vagina y que al abrirse con movimientos suaves se puede visualizar las paredes vaginales. El espéculo también posee un mango (Figura 1-C) con el cual nos permite realizar con diferentes movimientos la localización del cérvix uterino posicionando el espéculo de manera tal que no produzca sensación de malestar en la paciente. Una vez en correcta posición, éste lo podemos fijar con su respectiva perilla de ajuste (Figura 1-E), así como con el seguro de las valvas (Figura 1-D). El espéculo tiene dos entradas de quitar y poner, la que se encuentra situada en el mango nos permite fijar el iluminador (Figuras 1-F y 4-B) y la segunda situada en la valva superior nos permite poner el porta filtros barrera (Figuras 1-G y 2-A).1.- 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).
2.- El iluminador contiene el Diodo Emisor de Luz (LED) de Galio de Nitrógeno que brinda la luz al espéculo, este LED se caracteriza por su brillantez en la luz, con cable eléctrico de grado hospitalario, mismo que nos permite su esterilización.2.- 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.
3.- El iluminador (Figuras 1-A y 4- A) que consta de un Diodo Emisor de Luz (LED) de Galio de Nitrógeno con un espectro azul, está colocado en la parte distal del iluminador y está situado en el espéculo (Figuras 1-J y 4-D).3.- 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).
4.- El porta filtros barrera (Figuras 1-K y 2) se inserta en el labio posterior de la valva superior del espéculo mediante un clip de presión (Figuras 1-G y 2-A). El porta filtros es de forma anular con 2 anillos que permiten alojar el filtro barrera de manera sencilla (Figura 2-D), el filtro se aloja entre estos dos anillos (Figuras 2-B y 2-C).4.- 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).
5.- El iluminador se instala fácilmente en el mango del espéculo mediante el adaptador "U" que está fijado en el mango del espéculo (Figuras 1-1 y 4-B). De igual manera que el porta filtros, éste se inserta al espéculo en la valva superior mediante un clip de sujeción (Figura 4-C).5.- 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).
6.- El LED de Galio de Nitrógeno es alimentado por un cable eléctrico bipolar que proviene de una fuente de corriente eléctrica de bajo voltaje de corriente directa (Figuras 1-H y 4-E).6.- 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).
7.- La fuente de alimentación está constituida por una batería, ésta puede ser recargable mediante un sistema electrónico que permite su recarga en líneas de 120-220 volts de corriente alterna.7.- The power supply consists of a battery, it can be rechargeable by an electronic system that allows recharging in 120-220 volts AC lines.
8.- El interruptor de corriente se encuentra en el cable eléctrico, de los comúnmente llamados de paso, mismo que facilita su maniobrabilidad por el médico al realizar la exploración Técnica8.- The power switch is located in the electric cable, commonly called passage, which facilitates its maneuverability by the doctor when performing the scan Technique
Método de la Especuloscopía mediante el espéculo vaginal con un sistema y método específico para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino:Speculoscopy method using the vaginal speculum with a specific system and method for the diagnosis of lesions caused by the Human Papillomavirus in the female genital tract:
Método Clínico.Clinical Method
Hemos usado el fluorocromo Isotiocianato de Fluoresceina (FITC) por diversos motivos: Este es empleado ampliamente por los oftalmólogos, por vía intravenosa en las fluorangiografias (retina), y en solución local para ver las lesiones de la cornea, esto significa ninguna toxicidad de parte del colorante hacia la paciente.We have used Fluorescein Fluorochrome Isothiocyanate (FITC) for various reasons: This is widely used by ophthalmologists, intravenously in fluorangiographies (retina), and in local solution to see corneal lesions, this means no toxicity of part from the dye to the patient.
Procedimiento: • Colocar cómodamente a la paciente en posición ginecológica. La duración del estudio es de 10 minutos aproximadamente.Procedure: • Comfortably place the patient in a gynecological position. The duration of the study is approximately 10 minutes.
• Introducir el espéculo vaginal sin lubricantes.• Introduce the vaginal speculum without lubricants.
• Localizar el Cérvix.• Locate the cervix.
• Aplicar el Ácido Acético al 5% en el Cérvix durante un minuto. Esta solución acidificada tiene dos funciones, es un blanqueador de las células en las• Apply 5% Acetic Acid on the cervix for one minute. This acidified solution has two functions, it is a bleach of the cells in the
Neoplasias Cervicales Intraepiteliales (NIC), y es un agente copulador para el fluorocromo (FITC) con las células enfermas.Intraepithelial Cervical Neoplasms (NIC), and is a coupling agent for fluorochrome (FITC) with diseased cells.
• Aplicar uniformemente la solución de FITC (isotiocianato de fluoresceina) en el Cérvix por un minuto. • Encender el Diodo Emisor de Luz (LED).• Apply the solution of FITC (fluorescein isothiocyanate) evenly on the cervix for one minute. • Turn on the Light Emitting Diode (LED).
• Introducir el filtro supresor. Este es el paso más importante de los resultados, debido a que el diagnóstico es efectuado mediante este filtro, imagen con tejido fluorescente es positivo para infección por VPH, ausencia de tejido fluorescente negativo a infección de VPH, es decir paciente sana. Esta es la nueva imagen diagnóstica de fácil interpretación, motivo de la patente que estamos reclamando.• Insert the suppressor filter. This is the most important step of the results, because the diagnosis is made using this filter, imaging with fluorescent tissue is positive for HPV infection, absence of fluorescent tissue negative for HPV infection, that is, a healthy patient. This is the new diagnostic image of easy interpretation, reason for the patent we are claiming.
Los resultados son obtenidos en el mismo momento en que el procedimiento es efectuado y en el mismo sitio. The results are obtained at the same time the procedure is performed and in the same place.

Claims

Reivindicaciones Claims
Habiendo descrito suficiente la invención que hemos hecho, nosotros consideramos que nuestro invento, que es Un Nuevo Sistema y Método Específico de Especuloscopía para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino dentro de los Sistemas de Inspección Visual en el Mundo, y que por esta razón nosotros lo estamos reclamando como invención de nuestra propiedad está contenida en las siguientes cláusulas:Having sufficiently described the invention we have made, we consider that our invention, which is a New System and Specific Speculacopy Method for the diagnosis of lesions caused by the Human Papillomavirus in the female genital tract within the Visual Inspection Systems in the World, and that for this reason we are claiming it as an invention of our property is contained in the following clauses:
L- Especulo vaginal con un sistema y método específico para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino, caracterizado por la combinación de un espéculo vaginal estándar: Graves, Pederson etc., esterilizable o desechable con un sistema para producir fluorescencia mediante un Diodo Emisor de Luz (siglas en Ingles LED) de banda corta específica, montado en la parte superior del iluminador que se encuentra situado entre las 2 valvas del espéculo, sosteniéndose éste en el mango del mencionado espéculo, con la finalidad de emitir un rayo de luz azul de manera tal que el marcador Isotiocianato de Fluoresceina (FITC) con que es teñido el tejido y por sus características selectivas del método, únicamente el tejido epitelial dañado en las lesiones producidas por el virus del papiloma humano produzca el fenómeno de fluorescencia, y éste tejido sea observable mediante un filtro supresor, logrando un diagnóstico acertivo en el mismo momento en que se está efectuando el procedimiento, además de que se puede incorporar un sistema de lentes de aumento o bien un colposcopio.L- Vaginal speculum with a specific system and method for the diagnosis of lesions caused by the Human Papillomavirus in the female genital tract, characterized by the combination of a standard vaginal speculum: Serious, Pederson etc., sterilizable or disposable with a system to produce fluorescence by means of a specific short band Light Emitting Diode (acronym in English), mounted on the upper part of the illuminator that is located between the 2 leaflets of the speculum, holding it in the handle of the said speculum, with the purpose of emitting a blue ray of light in such a way that the Fluorescein Isothiocyanate (FITC) marker with which the tissue is stained and due to its selective characteristics of the method, only the damaged epithelial tissue in the lesions produced by the human papillomavirus produces phenomenon of fluorescence, and this tissue is observable through a suppressor filter, achieving an accurate diagnosis and At the same time the procedure is being performed, in addition to that a magnifying lens system or a colposcope can be incorporated.
2.- Espéculo vaginal con un sistema y método específico para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino, de acuerdo en la cláusula 1, el nuevo sistema de especuloscopía diagnóstica está caracterizado por la capacidad de usarse con espéculos vaginales comunes como son los de Graves, de Pederson u otras de este tipo, desechables o reutilizables. Que en asociación con el método específico de fluorescencia se logre un diagnóstico acertivo de las lesiones producidas por el virus del papiloma humano en el mismo momento en que se está efectuando el procedimiento. 2.- Vaginal speculum with a specific system and method for the diagnosis of lesions produced by the Human Papillomavirus in the female genital tract, according to clause 1, the new diagnostic speculoscopy system is characterized by the ability to be used with Common vaginal specula such as Graves, Pederson or others of this type, disposable or reusable. That in association with the specific fluorescence method, an accurate diagnosis of the lesions produced by the human papillomavirus is achieved at the same time the procedure is being performed.
3.- Espéculo vaginal con un sistema y método específico para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino, de acuerdo en la cláusula 1, el nuevo sistema de especuloscopía diagnóstica está caracterizado por usar un Diodo Emisor de Luz (siglas en Ingles LED) de Galio de Nitrógeno con una banda corta dentro del espectro luminoso, mismos que son requeridos para el sistema específico de fluorescencia con el marcador isotiocianato de fluoresceina (FITC), logrando un diagnóstico acertivo en el mismo momento en que se está efectuando el procedimiento.3. Vaginal speculum with a specific system and method for the diagnosis of lesions produced by the Human Papillomavirus in the female genital tract, according to clause 1, the new diagnostic speculacopy system is characterized by using a Diode Emitting Light (acronym in English LED) of Nitrogen Gallium with a short band within the luminous spectrum, which are required for the specific fluorescence system with the fluorescein isothiocyanate marker (FITC), achieving an accurate diagnosis at the same time The procedure is being carried out.
4.- Espéculo vaginal con un sistema y método específico para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino, de acuerdo en la cláusula 1, el nuevo sistema de especuloscopía diagnóstica está caracterizado por el uso de un iluminador en forma de la letra "L" invertida, su parte superior y mas corta se introduce en el centro de las valvas, sosteniendo al LED, permitiendo una amplia iluminación del cérvix uterino, en su parte mas larga este se sujeta al mango del espéculo mediante el adaptador "U", en su parte interna se encuentran los cables que suministran la corriente eléctrica, mediante el cable bipolar proveniente de la batería. El material del iluminador es esterilizable mismo que es requerido por el sistema, logrando un diagnóstico acertivo en el mismo momento en que se está efectuando el procedimiento.4.- Vaginal speculum with a specific system and method for the diagnosis of lesions caused by the Human Papillomavirus in the female genital tract, according to clause 1, the new diagnostic speculacopy system is characterized by the use of an illuminator In the form of the inverted letter "L", its upper and shorter part is introduced in the center of the leaflets, holding the LED, allowing ample illumination of the uterine cervix, in its longer part this is attached to the speculum handle by the adapter "U", inside are the cables that supply the electric current, using the bipolar cable from the battery. The material of the illuminator is sterilizable same as is required by the system, achieving an accurate diagnosis at the same time the procedure is being performed.
5.- Espéculo vaginal con un sistema y método específico para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino, de acuerdo en la cláusula 1, el nuevo sistema de especuloscopía diagnóstica está caracterizado por el uso de un filtro de corte o de supresión de banda ancha que permite el paso únicamente de la luz producida por el Isotiocianato de Fluoresceina (FITC) durante su excitación, este marcador del tejido lesionado por el virus del papiloma humano es excitado por la luz proveniente del Diodo Emisor de Luz (LED) , produciendo luz, este filtro suprime el paso de la luz producida por el LED y proporciona una imagen selectiva únicamente del tejido lesionado permitiendo identificar a éste, brindándonos un diagnóstico acertivo de la displasia en el mismo momento en que se está efectuando el procedimiento. 5.- Vaginal speculum with a specific system and method for the diagnosis of lesions caused by the Human Papillomavirus in the female genital tract, according to clause 1, the new diagnostic speculacopy system is characterized by the use of a filter of cutting or suppression of broadband that allows the passage of only the light produced by Fluorescein Isothiocyanate (FITC) during its excitation, this marker of the tissue injured by the human papillomavirus is excited by the light coming from the Emitting Diode of Light (LED), producing light, this filter suppresses the passage of light produced by the LED and provides a selective image only of the injured tissue allowing it to be identified, giving us an accurate diagnosis of dysplasia at the same time it is being made The procedure.
6.- Espéculo vaginal con un sistema y método específico para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino, de acuerdo en la cláusula 1, el nuevo sistema de especuloscopía diagnóstica está caracterizado por el uso de un adaptador "U" que permite la inserción mediante un clip del iluminador al mango del espéculo, logrando un diagnóstico acertivo en el mismo momento en que se está efectuando el procedimiento.6.- Vaginal speculum with a specific system and method for the diagnosis of lesions caused by the Human Papillomavirus in the female genital tract, according to clause 1, the new diagnostic speculacopy system is characterized by the use of an adapter "U" that allows insertion by means of a clip of the illuminator to the handle of the speculum, achieving an accurate diagnosis at the same time the procedure is being carried out.
7.- Espéculo vaginal con un sistema y método específico para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino, de acuerdo en la cláusula 1, el nuevo sistema de especuloscopía diagnóstica está caracterizado por un clip que permite la fijación del porta filtro barrera a la parte externa de la valva superior del espéculo y de igual manera nos permite introducir en el campo visual el filtro barrera para que permita identificar la lesión proporcionándonos un diagnóstico acertivo en el mismo momento en que se está efectuando el procedimiento.7.- Vaginal speculum with a specific system and method for the diagnosis of lesions caused by the Human Papillomavirus in the female genital tract, according to clause 1, the new diagnostic speculacopy system is characterized by a clip that allows fixing the barrier filter holder to the outer part of the upper leaflet of the speculum and in the same way allows us to introduce the barrier filter in the visual field so that it can identify the lesion providing us with an accurate diagnosis at the same time the procedure is being carried out .
8.- Espéculo vaginal con un sistema y método específico para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino, de acuerdo en la cláusula 1, el nuevo sistema de especuloscopía diagnóstica está caracterizado por un portafiltros barrera, mismo que consiste en dos anillos que están sujetos por una rosca mismos que permiten alojar al filtro barrera, mediante esta rosca de quitar, poner y dar una vuelta el filtro, es insertado con facilidad con la finalidad de proporcionar un diagnóstico acertivo en el mismo momento en que se está efectuando el procedimiento.8.- Vaginal speculum with a specific system and method for the diagnosis of lesions produced by the Human Papillomavirus in the female genital tract, according to clause 1, the new diagnostic speculacopy system is characterized by a barrier filter holder, same consisting of two rings that are held by a thread themselves that allow the barrier filter to be accommodated, through this thread to remove, put and turn the filter, it is easily inserted in order to provide an accurate diagnosis at the same time in that the procedure is being carried out.
9.- Espéculo vaginal con un sistema y método específico para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino, de acuerdo en la cláusula 1, el nuevo sistema de especuloscopía diagnóstica está caracterizado por una batería recargable mediante un convertidor de corriente de 110-220 Volts con la finalidad de proporcionar un diagnóstico acertivo en el mismo momento en que se está efectuando el procedimiento aun en los lugares mas distantes de la población. 9.- Vaginal speculum with a specific system and method for the diagnosis of lesions caused by the Human Papillomavirus in the female genital tract, according to clause 1, the new diagnostic speculacopy system is characterized by a rechargeable battery through a 110-220 Volt power converter in order to provide an accurate diagnosis at the same time that the procedure is being performed even in the most distant places of the population.
10.- Espéculo vaginal con un sistema y método específico para el diagnóstico de lesiones producidas por el Virus del Papiloma Humano en el tracto genital femenino, de acuerdo en la cláusula 1, el nuevo sistema de especuloscopía diagnóstica está caracterizado por un cable eléctrico sellado que proporciona la energía eléctrica al LED de grado hospitalario que permite su esterilización con la finalidad de proporcionar un diagnóstico acertivo en el mismo momento en que se está efectuando el procedimiento. 10.- Vaginal speculum with a specific system and method for the diagnosis of lesions produced by the Human Papillomavirus in the female genital tract, according to clause 1, the new diagnostic speculacopy system is characterized by a sealed electrical cable that It provides the electric power to the hospital-grade LED that allows its sterilization in order to provide an accurate diagnosis at the same time the procedure is being performed.
PCT/MX2007/000147 2007-12-04 2007-12-04 Vaginal speculum including a system and a specific method for diagnosing lesions caused by the human papillomavirus in the female genital tract WO2009072856A1 (en)

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MX2010005609A MX2010005609A (en) 2007-12-04 2010-05-21 Vaginal speculum including a system and a specific method for diagnosing lesions caused by the human papillomavirus in the female genital tract.

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CN105708410A (en) * 2016-01-20 2016-06-29 广州普露医疗科技有限公司 Vaginal uterine cervix examining and treating instrument

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