MXNL05000018A - Portable device for self-performing an uterine cervical cancer test by means of simultaneous electrical an optical measurements - Google Patents

Abstract

The present invention is related to a portable device for analyzing cervical tissue by means of two simultaneous measurements, namely an electrical measurement and an optical measurement. The aforementioned device examines different areas of cervical tissue, taking electrical measurements from same in different frequency ranges and optical measurements in three different wavelengths;a reading from both the electrical and optical measurements is taken and subsequently digitalized. Once the information have been obtained, it is compared with mathematical formulae stored in the device memory, so that three possible responses are obtained in real time as a prediagnostic. Said information may be stored in an external memory device so as to be compared with further information stored in an external database. The purpose of the present invention is to provide a minimally-invasive self-diagnostic device for Papanicolaou testing, and to offer women the alternative of visiting Gynaecologist or cytologist only if compulsory.

Description

"LAPTOP DEVICE FOR AUTODI AGNOSTIC TEST OF UTERINE CÉRVICO CANCER BY MEANS OF SIMULTANEOUS ELECTRICAL AND OPTICAL MEASUREMENTS " BACKGROUND OF THE INVENTION The identification of various types of tissues is based on the response of these to both the electrical stimulation and the response in the incidence of light. Currently there are various devices and techniques for the identification of different types of tissues, both normal, as well as tissues with human papillomavirus, precancerous and cancerous. There are several optical principles that are already proven for the identification of tissues such as Fluorescence or Spectroscopy, Raman Spectroscopy and OCT. As in the previous part, the biological tissues have a complicated electrical impedance, which is a function of frequency, this is because the tissue contains components that have both resistive and load storage (capacitive) characteristics. The magnitude of the impedance and its dependence on frequency are a function of the composition of the tissue. 5 The starting point of this investigation refers to the fact that no method has a sufficiently precise reliability, which gives us a high risk of a misdiagnosis, this becomes very important if we understand that this type of cancer can Being cured is detected at an early stage, otherwise it is deadly. . The conventional Papomaniacal test for cervical-uterine cancer has been practically the same for approximately 60 years. Since 1940 the percentage of deaths in women with cervical cancer has decreased by 70%, in large part because many women have had a Pap test or cervical cancer test. Although not infallible, this test detects 95% of cervical cancers and, more importantly, detects them in a state in which they are still not visible to the naked eye and, therefore, can be treated 5 and, almost invariably, cured. Here lies that every attempt to change the traditional method must be equal or better in the reliability aspect. At the moment countless investigations have been realized this thanks to the fact that the technology has evolved of unimaginable form, optical, electric, and biomedical investigations are had, in addition each one of these has different variables. For example, the article "Relation between tissue structure and imposed electrical current flow in cervical neoplasia" which refers to studies performed to how the cervix tissue reacts when electrical impulses are applied to different frequency ranges. For this development a thorough investigation has been made of all the parts involved in the invention, referring to the electrical measurement, the optical measurement, the related to the electronics within the device and the 5 materials that are going to be used for the assembly.

At present, there are inventions that use measurement of electrical dangers from tissue. Representative patents are: U.S. Patent No. 4,458,694, "Apparatus and method for detection of tumors in tissue"; U.S. Patent No. 5,353, 802, "Device for measurement of electrical impedance of organic and biological matefials"; U.S. Patent No. 5,361,762, "Apparatus for detecting properties, differences and changes of humans or animáis bodies"; and U.S. Patent No. 6,026,323, "Tissue diagnostic system". Regarding the optical part that is based on the methods of reflection of light from tissues representative patents sort the following; U.S. Patent No. 4,930,516, "Method for detecting cancerous tissue using visible native luminescence"; U.S. Patent No. 5,503,853, "Use of light conveyed by fiber optics to ligate tumors. Physiological test"; U.S. Patent No. 5,439,000, "Method of diagnosis tissue with guidewire", and U.S. Patent No. 6,026,323, "Tissue diagnostic system".

BRIEF DESCRIPTION OF FIGURES The drawings that accompany it are briefly described below. FIGURE 1. A schematic view of the apparatus of the present invention is presented. FIGURE 2. A side view of the specimen that is used in the present invention is presented. FIGURE 3. An isometric cross-sectional view of the housing or handle that is used in the present invention is presented. FIGURE 4. A cross-sectional view of the housing or handle that is used in the present invention is presented FIGURE 5. A view of the tip of the specimen that makes contact with the cervix is presented in the present invention. FIGURE 6. Block diagram of) operation for the device of the present invention.

DESCRIPTION OF THE INVENTION The invention presented in this document is a novel system designed for the detection of cancer, pre-cancer and human papillomavirus. The device is a portable optoelectronic self-diagnostic system. It is an instrument that is manipulated by the person who is going to apply the test and presents a result in real time without requiring taking physical samples of the tissue and transporting them to a laboratory for examination by means of a cytologist. In its outer part consists of three primordial parts the first is the housing (2) where is the entire electronic part of the system, consisting of a printed card which contains the LEDS necessary for optical measurement, as well as the photodiodes to receive the luminous intensity of the cells; it also contains a microcontroller which sends the signals for electrical stimulation, which is amplified by operational amplifiers to later stimulate the cells; the microcontroller receives the signals from the diodes and from the electrodes to make a digital analog conversion and interpret the measurements taken to give a real-time response; the second part is the specimen (1) where the fiber optic cables (4) that are required to transmit the emissions and the light receptions pass; on the other hand we have the tip of the test tube (3) where the emitting optical fibers (10) and receptors (11) are located, also the gold electrodes that generate the current (9), the fibers are in the middle of an epoxy resin (12) which protects the cables along the test piece which is made of a plastic material preferably sterilizable Ultem (8), the processing of the data collected in the different measurements is carried on an electronic card (6) where first the optical (13) and electrical signals (17) are sent, where both signals (14 and 18) are received in the central control system (15), to be processed (16) and the result is delivered in real time with the 3 (1 green indicating that the person is healthy, 1 yellow to indicate the presence of the Human Papillomavirus, 1 red indicating the presence of cancer cells) LEDs outdoors (7 and 19). In figure 5 there is shown a view of the tip of the specimen that makes contact with the cervix in the present invention where (8) is the Ultem (Polyetherimidex Probé), (9) gold electrodes (10 and 11) plastic optical fibers and (12) Epoxy resin. Figure 6 shows the flow diagram of the operation of the device, where 13 is the optical signal, 14 is the signal reception, 5 is the control block, 16 is the data processing, 17 is the sending of the signal electrical, 18 is the reception of the electrical signal and 19 is the emission of the prediagnosis in LEDs. The woman who applies the test passes the tip of the specimen through the cervix where measurements are made using electrical impulses at various frequencies, as well as pulses of light at three different wavelengths. The readings obtained from the measurements are compared with mathematical formulas programmed into the device in real time. The mathematical formulas were designed based on studies carried out where the impedance and luminous intensity values that must be obtained from the measurements made are known in advance. The value obtained in the central control is compared and classified as normal (green led) or abnormal (yellow or red LED). When an abnormality is found in the sample there are two possible causes of actions: Presence of the Human Papillomavirus (yellow LED lights), presence of cancer cells (the red LED lights up). This invention presents as its main characteristic that it is an instrument capable of making two simultaneous measurements, the electrical and the optical from very small sections of tissue, since currently there is no evidence that the tests affect each other. In addition, the device is portable and can be used as a self-diagnosis, that is, the person can be screened for cervical cancer without the help of another person, as explained above differs from all devices patented up to now such as the one titled, " Hybrid probé for tissue type recognition ", the one titled" Apparatus for tissue type recognition within a body canal ", the one titled" Integral sheathing apparatus for tissue recognition probes ", and the one titled" Tissue diagnostic system ". The invention consists in the sequence of tests carried out by the two methods of measuring the electrical and the optics, so that the tests are carried out properly, it is necessary that the tip of the specimen has contact with the cervix of the patient, it is important that the Measurement is made throughout the entire cervix to have a meaningful measurement of all tissues. In the case of the electrical part, the current of the surface is applied and this does not necessarily expand through the surface of the tissue, but penetrates into it at a certain depth, the characteristics of the electrical impedance of the tissues can be explained by changes in the arrangements of the cells and the size of the nucleus. This relationship is the basis for knowing the structure of the tissue based on the measurements of the electrical impedance spectrum, that is, this pattern will serve to differentiate normal from precancerous tissues. The major changes in the precancerous tissue occur in the subdivision into the superficial cell layers and there is an increase in the size of the nucleus. The proposed method is with a specimen of approximately 4.0 - 7.0 mm in diameter, with four gold electrodes of 0.8 - 1.2 mm in diameter, spaced between them with an intermediate circle of 1.5 - 2.0 mm, applying a current of 10 μA peak At peak for an effective measurement, the ratio between the measurement of the amplitude of the potential of the imposed current determines the transmitted impedance. In the case of the optical part, three different wave widths are sent and the luminous intensity with which each one returns is received. Because the size of the specimen is so small, the transmission is made throughout the specimen by means of optical fibers, these fibers are connected to the three LEDs to send the signal, while to read, there are six photodiodes. connected to fiber optic, then the signal is digitized and the comparison is made, to subsequently send the signal either normal or abnormal to deliver the final result to the user by means of three LEDs.

The best method to carry out both measurements successfully requires a series of steps that are briefly described below and in order: Place the tip of the specimen in the cervix and sweep it through; the electrical stimulation is carried out and the optical pulses are sent; the measurement of the impedance value and the light intensities is received, the signal is digitized, compared with the indicated values and a response is obtained immediately. It is advisable to do a sweep in the cervix of between one and two minutes to obtain a reliable measurement

Claims (1)

1. RE1NVIND1CACI0NES After having sufficiently described the invention, I consider as a novelty and therefore claim as my exclusive property contained in the following clauses: 1. A portable device for self-diagnostic test of cervical cancer by means of simultaneous electrical and optical measurements characterized in that it consists of three parts: a) A housing where the entire electronic part of the system is located, consisting of a printed card which contains the LEDs necessary for optical measurement, as well as the photodiodes to receive the luminous intensity of the cells; it also contains a microcontroller which sends the signals for electrical stimulation, which is amplified by operational amplifiers to later stimulate the cells; the microcontroller receives the signals from the diodes and from the electrodes to make the analogue digital conversion and interpret the measurements b) A specimen where the fiber optic cables required to transmit the emissions and the light receptions are contained. c) A set of emitting and receiving optical fibers placed at the tip of the specimen at the tip of the specimen where the emitting and receiving optical fibers are located, also the gold electrodes that generate the current, 2. A portable device for test of self-diagnosis of uterine cervical cancer by means of simultaneous electrical and optical measurements according to claim 1, characterized in that the fibers are in the middle of an epoxy resin which protects the cables along the specimen. 3. A portable device for self-diagnostic testing of uterine cervical cancer by means of simultaneous electrical and optical measurements according to claim 1 characterized in that the epoxy resin is made of a preferably sterilizable plastic material Ultem. 4. A portable device for self-diagnostic testing of uterine cervical cancer by means of simultaneous electrical and optical measurements according to claim 1, characterized in that it presents an electronic card receiving optical and electrical signals. 5. A portable device for self-diagnostic testing of uterine cervical cancer by means of simultaneous electrical and optical measurements according to claim 1, characterized in that the electronic card is connected to one or more external LEDs indicating the result. 6. A portable device for self-diagnostic testing of uterine cervical cancer by means of simultaneous electrical and optical measurements according to claim 1 characterized in that the electronic part is a printed card which contains LEDs, photodiodes, microcontroller, and operational amplifiers. RESET OF THE INVENTION The present invention relates to a portable device that analyzes the cervical tissue by means of two simultaneous measurements, an electrical and an optical. It examines different areas of the cervical tissue making different electrical measurements of it at wide ranges of frequencies, as well as optical measurements at three different wavelengths, then the reading of both electrical and optical measurements is made to later be digitized. After having the information this is compared with mathematical formulas stored in the memory of the device, to then give three possible answers in real time as pre-diagnosis. Also the same information collected can be stored in another external memory device to be compared with information in an external database. The object of this invention is to provide a self-diagnostic device for the Papanicolauo test, in order to make the device minimally invasive, with this it is sought that women only have to go to the gynecologist or cytologist if it is exclusively necessary.