SK1112024U1 - A portable device for analyzing biomarkers and its method of operation - Google Patents

Abstract

A portable device for analyzing biomarkers and its method of operation is described. The declared technical solution consists of a control module (1), which is connected to a measuring module (2), while the latter is conductively connected to the sensor (10). Within the measurement module (2) there is a block (9) of additional sensors installed in close proximity to the sensor (10), which is powered by the voltage generation block (6) and whose output is monitored by the small current measurement block (8) as well as by the (7) voltage measurements. The entire device is controlled by a microprocessor (3), which initializes measurements based on user commands obtained through the communication interface (4) and stores them in memory (5). The measurement itself takes place by inserting the sensor (10) into the device, creating a reference measurement before adding the solution matrix with the analyte, and then repeating it after the addition.

Description

The declared invention falls into the field of diagnostic devices. The portable device for the analysis of biomarkers and the way it works is a detection system for many civilizational diseases, which with minor modifications can be detected. The portable device for the analysis of biomarkers works on the principle of binding biomarkers to the sensor with subsequent divergence of its electrical characteristics.

Current state of the art

Analyzes focused on parameters such as the presence of specific biomarkers that work on the principle of molecular recognition are a key part of modern laboratory health tests. These biomarkers, which are often proteins or other molecules produced in the body in response to certain diseases or conditions, make it possible to diagnose and monitor a patient's health with high accuracy. Early diagnosis based on these analyzes can significantly alleviate the course of the disease and improve the prognosis for a significant proportion of patients.

One of the most used techniques for studying and evaluating biomarkers is enzyme-linked immunosorbent assay (ELISA). ELISA is a sensitive method that uses antibodies to detect the presence and concentration of specific biomarkers in biological samples such as blood or urine. This technique is highly accurate and enables the quantification of even very low concentrations of biomarkers, which is crucial for the early diagnosis of many diseases. However, the disadvantage of this technique is the time required to perform the analysis and the need for special laboratory equipment and environment. ELISA tests can be time-consuming, which may limit their applicability in emergency situations. In addition, they require trained personnel and adequate laboratory conditions, which can be problematic for some medical facilities. Therefore, new technologies and methods are currently being developed that could overcome these limitations. For example, the development of rapid tests based on biosensors and other innovative technologies promises to speed up the diagnostic process and simplify analyses, thereby improving the accessibility and efficiency of healthcare. These advances may revolutionize the diagnosis and monitoring of patients' health in the future, allowing for faster and more accurate interventions.

Biosensors can be classified as a subgroup of chemical sensors that can detect concentrations of biomarkers - analyte in a solution matrix. The analyte can be detected within the solution matrix in several ways, specifically with the help of a mass spectrometer using chromatography, or by absorbing radiation of specific wavelengths, by changing the conductivity of the sensitive captured layer or by changing the dielectric properties. However, several evaluation methods are expensive, large and slow, therefore biosensors based on organic transistors are coming to the fore. These sensors are mainly characterized by their compactness, high sensitivity and quick response to stimuli, while maintaining a low production price. In terms of construction, the biosensor can be divided into the element itself and bioreceptors. It is bioreceptors that play a key role in the detection of the mentioned biomarkers through biochemical reactions. These are special molecules that serve to bind the analyte. According to the bioreceptors used, biosensors can be classified into: antigenic, enzyme, DNA, and cellular. Bioreceptors are either covalently attached to the transducer or contained in the bioactive layer. The most common types of bioreceptors nowadays are antibody and enzyme.

However, the use of biosensors with a bioactive layer is characterized by several disadvantages, namely rapid degradation caused by the environment. At the same time, interpreting the signal from a biosensor with a bioactive layer requires precise laboratory equipment, which is in direct contrast to the low production costs of the sensor itself. The mentioned shortcomings provided an opportunity to solve this problem by appropriate technical means, specifically by means of the declared invention of a portable device for the analysis of biomarkers and its method of operation, which deals with a sensor based on organic semiconducting materials and a compact device capable of interpreting data from the mentioned sensor.

The essence of the invention

The declared invention consists of the device itself of a portable device for the analysis of biomarkers and a sensor. The sensor itself is formed by one organic field controlled by a transistor with a floating gate (electrode at a floating potential). The floating gate is treated with a suitable surfactant

SK 111-2024 U1 ensuring the adsorption of the analyte from the solution matrix. The OFET is subsequently controlled using a gate capacitor where the floating gate also represents an electrode with a floating potential.

The portable device for biomarker analysis consists of a measurement and control module. The control module consists mainly of a microprocessor responsible for the initialization of measurements, processing and rendering of data on the integrated display of the device. Using the communication interface, the microprocessor is able to transfer the measured data to a personal computer for further storage via USB. The measurement module is responsible for the course of measurements on the sensor, while it can be divided into a small current measurement block, a voltage generation block, a voltage measurement block and a block of additional sensors.

In the small current measurement block, there are DC/DC converters that create an isolated power supply for the ADC converter and the analog part itself. At the analog input of the measured signal of the ADC converter, there is a first-order low-pass filter for each channel with a cut-off frequency of at least 1KHz to eliminate spectrum mirroring caused by signal sampling. In the analog part, there are two transimpedance converters, which ensure reliable conversion of current to voltage with the possibility of switching ranges. The entire analog part of the small current measurement block is shielded, which prevents the influence of ambient interference on the very sensitive part of the transimpedance amplifier. The shielding is formed by a ferromagnetic sheet which is conductively connected to zero potential.

There are DC/DC converters in the voltage measurement block, which provide power to the ADC converter and the analog part. In the analog part, there are two voltage trackers, which ensure reliable voltage monitoring, with minimal influence on the measured signal. Subsequently, the voltage signal is transformed using a voltage divider and further adjusted for the ADC converter using operational amplifiers. Like the small current measurement block, this block is also galvanically isolated.

The voltage generation block is formed by a DAC converter, which ensures the conversion of a digital value into an analog signal. The second important part is the analog part, which amplifies the output of the DAC converter to the desired voltage level, up to ±32V maximum. The last part is the power supply part which supplies the necessary voltages and currents for individual parts.

Within the block of additional sensors there are commercial sensors aimed at detecting temperature, humidity, pressure and VOC (volatile organic compounds) and electronic circuits necessary for their correct functioning. The functionality of the block of additional sensors consists in monitoring the conditions under which the measurement itself takes place.

All blocks of the measuring part also contain a galvanic isolator, which ensures their galvanic separation and thus minimizes the risk of interference and noise transmission. Also, this optical isolator ensures safe and reliable communication between the measuring card and the base board through optical data transmission.

The operation of the device itself is conditioned by the insertion of the sensor into the device of the portable device for the analysis of biomarkers. The contacts of the sensor are connected to the measuring module, while the voltage generation block applies a constant voltage to the sensor. Through the block of voltage measurement and the block of small currents, the characteristic of the organic field controlled transistor with a floating gate is obtained. These data represent a reference measurement that is initiated prior to the addition of the solution matrix to the extended gate of the sensor. Subsequently, after the addition of the solution matrix, which contains the analyte, it is bound by means of the surfactant to the extended gate. Subsequently, the charge-modulated organic transistor is controlled by means of a gate control capacitor, where the floating gate represents an electrode with a floating potential. This changes its transmission and output characteristics, which are evaluated on the basis of data obtained through the current measurement block and the voltage measurement block.

Overview of images on drawings

fig. no. 1: Block diagram of a portable device for biomarker analysis

Implementation examples

Individual embodiments according to the technical solution are presented for illustration and not as limitations of the technical solutions. Those skilled in the art will find or be able to find, using no more than routine experimentation, many equivalents to specific embodiments of the technical solution. Such equivalents will also fall within the scope of the following protection claims.

SK 111-2024 U1

Example 1

In this example of a particular implemented system of the technical solution, a portable device for analyzing biomarkers and the sensor 10 itself are described.

The portable device for the analysis of biomarkers consists of a control module 1 and a measurement module 2. The control module consists of a microprocessor 3 responsible for initializing measurements, processing and rendering data on the integrated display of the device and storing them in memory 5. Using the communication interface 4, the microprocessor 3 is capable of transmitting measured data to a personal computer for further storage via USB. The measurement module 2 is responsible for the course of measurements on the sensor 10, while it can be divided into a small current measurement block 8, a voltage generation block 6, a voltage measurement block 7 and a block 9 of additional sensors, while all blocks communicate with the microprocessor 3 via PCI-E connector.

Within block 8 of small current measurement there are two DC/DC isolated converters that create an isolated power supply for the ADC converter and the analog part of block 8 of small current measurement. The first DC/DC converter serves to convert the voltage from 5V to ±3.3V, which is subsequently stabilized by an LDO stabilizer to +2.5V and an LDO stabilizer to -2.5V, which power the analog part. The type of DC/DC converter is used to convert the voltage from 5V to 5V, which is then stabilized by an LDO stabilizer to +3.3V for powering the digital part of the ADC converter, while the type of LDO stabilizer to +3.3V is used to power the analog part of the ADC converter. In addition to these two LDO stabilizers, there is also a 3.3V voltage reference for the ADC converter on this DC/DC converter. In the analog part, there are two transimpedance converters based on operational amplifiers. While for current to voltage transformation, quality thin-film metallic SMD resistors with values of 100Ω, 100kΩ and 100ΜΩ were used, which represented the measurement ranges of +-20nA, +- 16uA and +- 16mA.

The most important part in block 6 of voltage generation is the DAC converter, which ensures the conversion of a digital value into an analog signal. The second important part is the analog part which amplifies the output of the DAC converter to the desired voltage level, up to ±32V maximum.

Block 7 of voltage measurement consists of six DC/DC isolated converters. The first DC/DC converter provides a +3.3V power supply for the digital part of the ADC converter, while the other DC/DC converters are connected in series with the outputs and together generate voltages of ±36V, which is then stabilized and supplies the analog part. In the analog part, there are two voltage trackers, which ensure reliable voltage monitoring, with minimal influence on the measured signal. These voltage followers are based on operational amplifiers. Subsequently, the voltage signal is transformed using a voltage divider and further adjusted for the ADC converter using operational amplifiers.

In block 9 of additional sensors there is a temperature, humidity and VOC sensor with their adjustment components. The basis of the selected sensor element is an organic field-controlled transistor with a floating gate in the top contact botom gate structure. The thickness of the deposited organic semiconductor DNTT was 100 nm, while maintaining a channel width of 100 μm and a length of 5 mm.

Example 2

The principle of operation of the invention of the portable device for biomarker analysis is based on the generation of a voltage signal through the voltage generation block 6, while the response of the sensor 10 is simultaneously sensed. Specifically, the entire measurement takes place by initializing the voltage measurement block 7 and the small current measurement block 8 during voltage generation. Subsequently, the sensor 10 is inserted into the device, where the appropriate measurement method is selected. For the measurement of sensor transistors, it is the measurement of the transfer characteristic, where the corresponding measurement ranges are also loaded. After reading the relevant measurement parameters, the measurement cycle is started, which consists in setting a constant voltage to the electrodes of the sensor 10 and obtaining a reference transfer characteristic with a gradual sweep of the voltage in the relevant ranges.

Subsequently, a solution matrix containing an analyte is placed on the floating gate of the sensor 10, which changes the potential on the given gate and thereby changes its output electrical parameters. After applying the analyte to the floating gate, the measurement of the transfer characteristic of the sensor 10 is performed again. From this, the rate of change of the threshold voltage parameter, which corresponds to the rate of detection of the selected substances, is subsequently evaluated.

Industrial applicability

Industrial applicability of the declared technical solution. A portable device for the analysis of biomarkers, it consists in the detection of the analyte in different solution matrices. The device can therefore be used in healthcare to detect the presence of specific biomarkers in blood with high accuracy while maintaining a low production and operating price.

SK 111-2024 U1

List of relationship tags

1. Control module

2. Measuring module

5 3. Microprocessor 4. Communication interface 5. Memory 6. Voltage generation block 7. Voltage measurement block 10 8. Small current measurement block 9. Block of additional sensors 10. Sensor

Claims (6)

1. A portable device for the analysis of biomarkers, characterized in that it consists of a control module 1, which is connected to a measurement module 2, while the latter is conductively connected to a sensor 10. 2. A portable device for analyzing biomarkers according to claim 1, characterized in that the measurement module 2 consists of a block 9 of additional sensors mounted in close proximity to the sensor 10, which is powered by a voltage generation block 6 and whose output is monitored by a small current measurement block 8 as well as block 7 of voltage measurement. 3. Portable device for biomarker analysis according to claim 1, characterized in that the control module 1 consists of a microprocessor 3, a communication interface 4 and a connected memory 5. 4. A portable device for the analysis of biomarkers according to claim 1, characterized in that the sensor 10 is formed by one organic field controlled by a transistor with a floating gate. 5. The method of operation of the portable device for the analysis of biomarkers, characterized in that the measurement is initialized by a command from the microprocessor 3 followed by voltage generation on the voltage generation block 6, the measurement is initialized through the voltage measurement block 7 and the small current measurement block 8, a reference is obtained transfer characteristic, the solution matrix containing the analyte is added to the floating gate of the sensor 10, the measurement is re-initialized through the voltage measurement block 7 and the block 8 measurements of small currents and a new transmission characteristic is obtained, the microprocessor 3 evaluates the differences in the characteristics and then they are stored in the memory 5. 6. The method of operation of the portable device for analyzing biomarkers according to claim 5, characterized in that during the measurement the surroundings of the sensor 10 are monitored using a block 9 of additional sensors.