Portable electronic sensor for detection of volatile amines in the exploration of the female genital tractSector of the techniqueI. - Medical sector: a) .- Medical devices, b) .- Diagnostic tests for office and field.
II. - Technological sector: a) .- Electronic sensory equipment, b) .- Volatile amines detectors, c) .- Medical instrumentation.
State of the artFrom the second half of the 19th century, chemistry, physics and electronics technologies have given rise to a plethora of scientific and technological developments for medical diagnoses and treatments, resulting in new devices, with which it has been possible to investigate and to understand more the interaction of medical, chemical, physical and electronic instrumentation with the biological tissues belonging to the field of immunohistochemistry and pathology, thus, having as a target, as in our case, the study, diagnosis and treatment of the genital tract female.
Given that infectious and sexually transmitted diseases are currently considered emerging, as a consequence there has been an increasing demand to solve diseases of the genital tract of women, leading to the development in the last twenty years of new medical devices, both for diagnosis as for medical treatment, however these new methods have different disadvantages, among them the high economic cost that implies its use, even in developing countries it is almost impossible to be at the required technological level.
As an example of equipment and methods of advanced technology in developed countries for diagnosis in the area of sensors we can mention: The ion mobility spectrometry (Ion Mobility Spectrometer IMS) of biogenic amines, product of the pathogens of the genital tract, this same graphic equipment and determines these amines qualifying and quantifying them, the problem is that it requires high training and knowledge for the staff that manages the team.
A method that to say this is economical for the diagnosis of infectious diseases of the genital tract, has been the "Direct Preparation of the Drop" with a correct diagnosis in 60-70%, which consists of taking with a handle of platinum two drops of vaginal discharge, the first of which is placed on a slide or slide and mixed with a drop of physiological saline covering it with a coverslip for observation under a microscope. The second drop is also placed on a slide to which a drop of 10% Potassium Hydroxide (KOH) is added. This sample is placed close to the doctor's nose so that the test of the known amines can be made through the nose. also as proof of Whiff, if in about thirty seconds have been released amines of unpleasant smell we are facing an exaggerated growth of pathogens.
The use of the microscope by means of the microscopic technique of "phase contrast" of the first lamina through objectives and capacitor "Ph" of 10 and 40 increases respectively is a visualization method that allows us to observe in a fast way the pathogenic germs of the diseases, as well as the state of the genital epithelial cells looking also in each microscopic field for the number of leukocytes.
A third drop can be placed on a litmus paper to measure the PH (Acid-Basic) of the genital exudate.
The disadvantage of microscopy is that the gynecologist must be very familiar with what he is seeing and generally prefers to resort to other laboratory studies, with the consequence that patients do not have the appropriate treatment, since it is not applied at the same time. the query.
BACKGROUND OF THE INVENTIONIn order to fully understand the operation and benefits of this new device, the concepts required for this are first described.
Infectious diseases of sexual transmission (STD) are those that are transmitted during sexual intercourse, these are usually asymptomatic and any sexually active person is at risk of acquiring them.
There are several types of pathogenic microorganisms that produce them, these can be: mycosis-producing fungi, bacteria, protozoa and viruses.
Vaginosis is a pathological process that affects the vagina and is considered a syndrome due to alterations of the bacterial flora that results in physicochemical changes of the vaginal secretions and in which the characteristics of the host and his sexual partner intervene. It is the current term that has been conferred is: a clinical polymicrobial syndrome that is characterized by presenting an abnormal vaginal discharge with disturbances in the vaginal ecosystem with displacement of lactobacillus by pathogenic microorganisms.
In a large part of the infected cases, we found the combination of multiple pathogens. Vaginosis and cervicitis continue to be the most frequent female genital tract disorder in women of reproductive age, with a high economic impact on a global scale.
The amines test or Whiff test, the amines (trimethylamine, putrescine and cadaverine) are produced by the vaginal flora combined with pathogenic germs and are detected when the vaginal secretions are mixed with potassium hydroxide in a lamella or porta-objects. The smell of amine recalls the smell of fish, this occurs when a drop of vaginal discharge is mixed with a drop of 10% potassium hydroxide. This odor does not occur in the absence of pathogenic germs.
The amines test used alone predicts the diagnosis of vaginosis in exactly 94% of patients.
A sensor is a device that physically measures and detects a quantity of something and converts it into a signal, which can be read by an observer or an instrument.
ProblematicFrequently, diseases of infectious etiology of the female genital tract are not easily diagnosed or treated, as they are lacking in the fieldof a team's office and tests that easily facilitate the diagnosis of these, which causes the gynecologist to have to resort to laboratory tests with a large margin of error, or to the use of sophisticated and high-cost equipment, which requires of a long time of training for its users, in addition that these teams are available only in the industrialized countries, and not to the technological reach in the developing countries by multiple factors.
The use of the microscope using the phase contrast technique for observing vaginal secretion was also mentioned previously, but there are very few gynecologists with training in microscopy techniques (such as phase contrast, dark field, contrast). differentiated, etc.), so in most gynecological offices there are no microscopes.
The great help that the test of the amines gives us is unquestionable, a low cost of the test with a high precision of the diagnosis, however there are errors because it is left to consideration of the doctor's sense of smell, and besides that in the Patients seeing that the doctor brings the sample that he got from his vagina to his nose causes a bad impression and psychological discomfort.
All this results in the patients, the consequent waiting times of the results, multiple consultations, inadequate treatments, psychological discomfort and therefore increasing the costs for patients, when the ideal is to see and treat properly in a single consultation.
Today in the technological advance of robotics and electronics it is common to see that there is a wide range of electronic sensors: smoke alarms, distance sensors, pressure and position sensors, sensors for various types of gases such as C02, CO, steam of alcohol, etc. however, these have not been used in clinical practice.
Objective of the present inventionIn order to solve the aforementioned problems, the creation of this new invention was conceived: "Portable electronic sensor for the detection of aminesvolatile in the exploration of the female genital tract ", which serves to make the diagnosis early and provide timely treatment in diseases of infectious etiology of the female genital tract, to be acquired by the doctor the required information of the disease in real time, that is, it is an instrument with the "See and treat" imperative.
With the new "Portable electronic sensor for detection of volatile amines in the exploration of the female genital tract", expensive studies are avoided, annoying maneuvers for women that cause psychological discomforts and long-term procedures to have a highly reliable result in terms of detection and treatment of diseases of infectious origin of the female genital tract.
Description of the equipmentThe invention described and detailed in this document and its systems basically comprise an electronic device that detects the presence and quantity of amines (triethylamine, putrescine and cadaverine) that help the doctor to determine an accurate diagnosis in the presence of genital tract infections. female.
This device also has the option of giving values with visual, numerical and auditory information to the presence and quantity of amines, as well as a registration form that facilitates the way of saving data for future research studies and patient history. .
This detection is aided by sensors and LED screens that determine with color code the presence of exuberant or poor amines. The test of the amines alone has shown an accuracy in diagnosis with 94% which induces that this device will cover with that precision but in turn reduction in costs, time and autonomy for the doctor who uses it.
The reduction in costs, times and autonomy are due to the fact that thanks to the possibility of diagnosis with the electronic nose, doctors no longer have to wait for the laboratory result, the tests of the amines in combination with this noseThe electronic system may be within the economic reach of various media and countries, improving the doctor's accuracy in its diagnosis.
Sets of parts in the portable electronic sensorThe new portable electronic sensor is integrated by several parts that structure your system. To understand we have: mechanical and electronic parts, structuring:I.- Mechanical Set:First constituted by the cabinet that is the structure or skeleton, which contains and serves as support for the electronic parts of the equipment, it may be bakelite, metal, rigid plastic, PBC or any other material for this purpose.
At the base of this structure we find the bracket of the heating resistance.
Continuing with the slide holder that enters and leaves the cabinet. Above is the sensor holder. Above this is the air passage regulator as well as the fan holder. In the upper part of the cabinet there are small holes that allow ventilation. Inside and on the sides there are the rails where the electronic circuits are placed. Also the space for the speaker or buzzer and the spaces for the mini ammeter, digital numbers and the colored LEDs.
Solar cells and rechargeable batteries are placed behind the structure.
II.- Electronic set:It is basically constituted by: thermal resistance, sensor (s), fan, electronic circuits, ammeter, buzzer or buzzer, memory (s), colored LEDs, batteries, digital numbers, solar cells and switches.
Operation and handling of the portable electronic sensor for the detection of volatile amines in the exploration of the female genital tractThe management shown below when performed in practice is not restrictive as it is not a limiting example in the use of the device, since this instrument is designed for multiple applications in the present and in the future within the medical area.
• Place the patient comfortably in a gynecological position. The duration of the study is 10 to 5 minutes.
• Introduce a vaginal speculum.
• The sample of our patient is taken.
• This is placed on the electronic nose foil, a drop of 10% KOH is added.
• The regulator of the air passage of the equipment is closed.
• The foil is introduced into the equipment and heated under induction, raising the temperature of the sample.
• The sensor captures the particles and quantifies them.
• This information is transmitted to an electronic system that determines the severity of the infection in the sample.
• According to the severity of the infection and the criterion, the electronic nose generates the following answers: Numerical, visual and auditory supported ammeter, LED screen, buzzer and digital numbers.
• At the end of the equipment, it gives two beeps showing that it has finished examining the result and the air dosimeter of the equipment opens.
• At the end of the examination of the sample the fan is activated and by air dosificador, the cleaning of particles takes place also giving freshness to the system inside, being ready for the next sample to examine.
• At this time you can remove the vaginal speculum or continue with the gynecological examination if required.
The result can be communicated to the patient in an easy and quick way.
Description of team activities• Sample-sensor interaction.
• Data transmission in Analog and Digital form.
• Result of the data in digital form: Numerical, visual and auditory.
• Clean the particle system by ventilation.
• And again to the first step.
Description of the figureParts:I. - Air doser (or air passage regulator)2 - . 2 - Fan3. - Digital numbers4. - Solar cells5. - LED screen (intensity)6. - Rechargeable battery7. - Rest of the foil8. - Laminate heat induction system9. - Ammeter10. - SensorI I. - Memory and software system12. - Horn13-Chamber of vapors of the foil