A portable non-invasive early thrombus screening device

Abstract

The present invention relates to a portable non-invasive early thrombus screening instrument, which includes a separable optical probe and an instrument main body. The separable optical probe is attached to the skin surface of the user to perform optical detection on this part and transmit the detection data to the instrument main body. The instrument main body is used to receive and analyze the data sent by the separable optical probe and display the analyzed thrombus monitoring results. The present invention monitors the hemodynamic changes in the corresponding area of the body through the separable optical probe, converts the obtained optical signal into an electrical signal, and then through the modified Beer-Lambert law for the processed data, the corresponding hemodynamic parameters can be obtained, providing a long-term dynamic display of the thrombus changes for users at home or during outdoor activities, realizing the function of non-invasive and instant monitoring of thromboembolism, facilitating the early screening of thrombus quickly and conveniently, and avoiding possible risks.

Description

Technical Field

[0001] The present invention belongs to the technical field of biomedical engineering, and in particular, to a portable non-invasive early thrombus screening device. Background Art

[0002] Thromboembolism is a potentially lethal disease caused by the formation of blood clots in arteries or veins. Once a thrombus is formed, it will slow down or block normal blood flow, and even break off and migrate to other organs. Moreover, thromboembolism can also lead to serious consequences. For example, the three major killers of cardiovascular diseases: myocardial infarction, stroke, and venous thromboembolism (VTE), are all closely related to it.

[0003] The Expert Committee of "World Thrombosis Day" released a global disease burden research report on the world's first "World Thrombosis Day". The article shows that the annual incidence of VTE globally is close to 10 million cases, and the annual incidence rate of the population is between 0.75‰ and 2.69‰. The incidence rate of people over 70 years old increases to between 2‰ and 7‰. Since thrombus is not easily detectable in the early stage of the disease, if the patient goes to the hospital for treatment when the disease breaks out, the condition of the thrombus is already relatively serious at this time. And the onset of thrombus will cause strong physiological reactions in the patient, and even endanger the patient's life. Therefore, it is necessary to develop a portable and non-invasive early thrombus screening device, which can not only monitor the thrombus condition of a specific part of the user in real time, but also play a role in early screening of thrombus to avoid the expansion of risks.

[0004] There is no dedicated thrombus monitor on the market at present. Generally, devices such as CT angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA) are used to monitor thrombus. These devices are all very professional and need to be operated by professional medical staff in the hospital to monitor patients. Moreover, the above devices are not portable monitoring devices, do not support patients to use at home or outdoors, and all require large-scale systems to support, are not suitable for long-term continuous monitoring, and are not suitable for local thrombus monitoring and thrombus disease monitoring.

[0005] After retrieval, the following patent documents related to thrombus monitoring instruments were found: a utility model patent for a thrombus monitoring and warning device (patent publication number CN217138071U), a non-destructive intelligent thrombus detection device based on EMD and neural network (patent application number 202110884748.2), and a cerebrovascular thrombus detection device (patent publication number CN112618233B). Among them, the patent document "a thrombus monitoring and warning device" only uses the difference in skin tension and temperature difference of the patient as the judgment basis for whether a thrombus is formed during monitoring, with low reliability. Moreover, when in use, sensors need to be pasted on the big feet, calves, and ankles of both sides of the patient's limbs, which is not portable and the operation is relatively complex and requires the assistance of others; the patent document "a non-destructive intelligent thrombus detection device based on EMD and neural network" uses ultrasonic Doppler technology to detect the thrombus situation in the blood flow. During monitoring, the instrument needs to be worn around the neck, which has great limitations and can only be used to detect thrombus situations in the neck and cannot detect the limbs; the "cerebrovascular thrombus detection device" can only be used for hospital monitoring. This device is not portable and is not conducive to actual operation, requiring professional medical staff to operate. Summary of the Invention

[0006] The purpose of the present invention is to overcome the deficiencies of the prior art and propose a portable non-invasive early thrombus screening instrument, which can provide users who are at home or engaged in outdoor activities with a long-term dynamic display of thrombus changes, give early warnings to users in real time, and avoid possible risks.

[0007] The technical problems of the prior art are solved by the present invention by adopting the following technical solutions:

[0008] A portable non-invasive early thrombus screening instrument includes a separable optical probe and an instrument main body. The separable optical probe is attached to the user's skin surface to perform optical detection on this part and transmit the detection data to the instrument main body. The instrument main body is used to receive and analyze the data sent by the separable optical probe and display the analyzed thrombus monitoring results;

[0009] The separable optical probe includes a micro-control processor and a near-infrared light source, a photosensitive detector, a light source driving module, a power supply and charging module connected thereto; the near-infrared light source is used to emit three wavelengths of near-infrared light; the photosensitive detector is used to collect optical signals and convert them into corresponding digital electrical signals for processing; the light source driving module drives the near-infrared light source to work; the micro-control processor controls the light source driving module to sequentially light up the near-infrared light source according to a set time sequence, receive the data collected by the photosensitive detector and transmit it to the instrument host part; the power supply and charging module is responsible for supplying power to the separable optical probe;

[0010] The main body of the instrument includes a main control unit module, a power supply circuit module, a data processing module, a data storage module, and a data display module connected thereto; the power supply circuit module supplies power to the entire early thrombosis screening instrument; the data acquisition module converts the collected analog signals for convenient analysis and storage; the main control unit module is used to receive the data sent by the separated optical probe, convert it into hemodynamic parameter changes by the modified Beer-Lambert law, store the data as hemodynamic data, and transmit the measured data to the data display module in real time to display the detection results;

[0011] The method for the main control unit module to obtain hemodynamic parameters using the modified Beer-Lambert law is as follows:

[0012] ⑴ The relationship between the light intensity (OD) and HbO 2 , Hb can be obtained through the modified Beer-Lambert law as OD γ :

[0013]

[0014] where OD represents the light intensity, the subscript symbol γ represents the wavelength of the near-infrared irradiation light, and correspond to the molar extinction coefficients of HbO 2 , Hb at the wavelength value of γ respectively; PLF is the differential path length factor, d SD is the symbol representing the interval between the near-infrared light source and the photosensitive detector, and this value is a fixed constant value, C[HbO 2 and C[Hb] represent the numerical values of the corresponding HbO 2 , Hb at a specific time;

[0015] ⑵ Based on the modified Beer-Lambert law, under the condition that the absorption coefficient changes little, the relationship between the concentration changes (Δ[o-Hb], Δ[deo-Hb]) of the main substances o-Hb and deo-Hb that cause light attenuation in tissues and ΔOD is:

[0016]

[0017] In the formula, ΔOD 1 and ΔOD 2 represent the light density changes of two different wavelengths of light respectively; c, c', v, and v' are two groups of coefficients to be determined. When the blood concentration remains unchanged and the concentration of deoxyhemoglobin is 0, ΔOD 2 and ΔOD 1, whose ratio is equal to v / c; ΔOD measured in two states where the deoxyhemoglobin concentration is 0 and the oxyhemoglobin concentration is 0 respectively 1 The ratio is equal to c / c';

[0018] (3) The ratios of the undetermined coefficients v / c, v' / c' and c / c' are converted into ratios of optical densities and measured as follows:

[0019]

[0020] (4) According to (2) and (3), the conversion formulas of ΔOD with respect to Δ[o-Hb] and Δ[deo-Hb] are derived:

[0021]

[0022] where R is related to the optical path differential factor, and this value is 1. Then, by experimental methods, v / c, v' / c' and c / c' are measured according to (3). Finally, the relative quantity measurement formula for measuring tissue blood oxygen saturation is obtained through formula (4);

[0023] The separable optical probe further includes an auxiliary monitoring module, and the auxiliary monitoring module includes a temperature sensor, a pressure touch sensor, etc., for detecting human physiological parameters related to thrombus onset;

[0024] The near-infrared light source emits three wavelengths of near-infrared light under the control of the micro-control processor and driven by the light source driving module; the light source driving module lights each wavelength of the multi-wavelength near-infrared light source in a certain time sequence, and the lighting frequency of each wavelength of the near-infrared light source and the luminous power of the near-infrared light source are regulated by the light source driving module;

[0025] The wavelength ranges of the three wavelengths of light are: 700nm - 750nm, 750nm - 800nm, 800nm - 850nm;

[0026] The separable optical probe is encapsulated together by a flexible material, and is arranged in a linear layout with the photosensitive detector as the center and two near-infrared light sources surrounding the photosensitive detector. The distance between the center of the near-infrared light source and the center of the photosensitive detector is 20mm - 40mm.

[0027] Furthermore, the separable optical probe further includes a first wireless communication module connected to the micro-control processor, and the instrument main body part further includes a second wireless communication module connected to the main control unit module. The separable optical probe and the instrument main body part realize data interaction functions through the first communication module and the second communication module. The second communication module also performs data transmission and storage with a mobile phone or a tablet computer through Bluetooth or WIFI transmission methods.

[0028] Furthermore, the separable optical probe and the instrument main body are respectively provided with serial communication interfaces connected to the micro-control processor and the main control unit module, and the separable optical probe and the instrument main body realize the data interaction function through the serial communication interfaces.

[0029] Furthermore, the instrument main body further includes an alarm module connected to the main control unit module. When the measurement result is greater than the set threshold, an alarm is given through the alarm module.

[0030] Furthermore, the power supply module includes a wired power supply part and a wireless charging part. The wired power supply part is used to supply power to the instrument main body. When the instrument main body is not in use, the separable optical probe is received inside the instrument main body, and the two are inductively coupled to supply power to the separable optical probe by the instrument main body.

[0031] The advantages and positive effects of the present invention are:

[0032] 1. By using the separable optical probe to monitor the hemodynamic changes in the corresponding body area, the present invention converts the obtained optical signal into an electrical signal, and then through the modified Beer-Lambert law for the processed data, the corresponding hemodynamic parameters can be obtained, providing a long-term dynamic display of the thrombus changes for users at home or during outdoor activities, realizing the function of non-invasive and immediate monitoring of thromboembolism, facilitating the early screening of thrombus quickly and conveniently, and at the same time providing a warning for patients according to the degree of thromboembolism to avoid possible risks.

[0033] 2. The present invention adopts a flexible and lightweight separable optical probe, which can realize the functions of self-test and other-test, meet the needs of multiple scenarios, can perfectly fit the measured part, and has the advantages of directly monitoring the hemodynamics of the relevant part, being portable, non-invasive, continuously diagnosable, quickly diagnosable and highly reliable. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 is the circuit block diagram of the present invention;

[0035] Figure 2 is the layout diagram of the one-word probe with two near-infrared light sources and a single photosensitive detector adopted by the present invention;

[0036] Figure 3 is the circuit block diagram of the first embodiment of the present invention;

[0037] Figure 4 is the circuit block diagram of the second embodiment of the present invention;

[0038] Figure 5 is the structural schematic diagram of the movable monitoring handle of the second embodiment of the present invention. Detailed implementation manners

[0039] The embodiments of the present invention will be further described in detail below with reference to the accompanying drawings.

[0040] A portable non-invasive early thrombus screening instrument, as Figure 1 shown, includes a separable optical probe and an instrument main body part. The separable optical probe is attached to the skin surface of the user to perform optical detection on this part and transmit the detection data to the instrument main body part. The instrument main body part is used to receive and analyze the data sent by the separable optical probe, inform the user of the thrombus monitoring result and provide an alarm function.

[0041] The separable optical probe includes a near-infrared light source, a photosensitive detector, a light source driving module, a micro-control processor, a first wireless communication module, a power supply and charging module, and an auxiliary monitoring module. The near-infrared light source is used to emit three kinds of near-infrared light suitable for the present invention; the photosensitive detector is used to collect optical signals and convert them into corresponding digital electrical signals for processing; the light source driving module can make the three-wavelength near-infrared light source light up and go out successively according to requirements; the first wireless communication module communicates with the instrument main body part to realize functions such as data transmission; the micro-control processor controls the light source driving module to light up the near-infrared light source in sequence according to the set timing, and at the same time receives the data collected by the photosensitive detector, encodes and transmits it to the instrument host part through the wireless communication module; the power supply and charging module is responsible for supplying power to the separable optical probe; the auxiliary monitoring module is used to monitor some human physiological signals such as body temperature and pressure touch.

[0042] The near-infrared light source is used to emit two or more near-infrared lights of three kinds of wavelengths; the wavelength ranges of the three kinds of wavelengths are: 700nm - 750nm, 750nm - 800nm, 800nm - 850nm.

[0043] The near-infrared light source and the photosensitive detector are arranged in a linear layout with the photosensitive detector as the center and the near-infrared light source surrounding the photosensitive detector. The distance between the center of the near-infrared light source and the center of the photosensitive detector is 20mm - 40mm, as Figure 2 shown.

[0044] The separable optical probe is internally provided with a power supply and charging module. This power supply and charging module charges with the power supply circuit module of the instrument main body part to maintain the power of the separable optical probe, so as to ensure the normal operation of each module of the separable optical probe.

[0045] The first wireless communication module is used to receive the relevant instruction information sent by the instrument main body part, and at the same time transmit the collected information to the second wireless communication module of the instrument main body part for later analysis and processing.

[0046] The auxiliary monitoring module includes a temperature sensor, a pressure touch sensor, etc., which are used to detect human physiological parameters related to thrombus attacks, such as temperature and pressure touch. The following auxiliary functions can be realized through the auxiliary monitoring module:

[0047] (1) Since a thrombus will block blood vessels, resulting in restricted blood return, causing limb swelling, local tissue ischemia, which may trigger inflammation, causing local body temperature to rise, and at the same time the skin tension increases, and the skin color will turn cyanotic or purplish-red. Therefore, the auxiliary monitoring module is used to help the overall system to assist in judging the occurrence of thrombus.

[0048] (2) The temperature sensor in the auxiliary monitoring module is used to monitor the temperature of the human body part. To avoid the influence of light source heating, the central position of the temperature sensor should be far away from the light source and set at a distance of 1 mm to 5 mm from the photosensitive detector.

[0049] In this embodiment, the split optical probe encapsulates the above modules together through a flexible material. The positional relationship between the two light sources and a photosensitive detector is as Figure 2 shown. The value of d1 (the distance between the left near-infrared light source and the photosensitive detector) should be between 20 mm and 40 mm, and the value of d2 (the distance between the right near-infrared light source and the photosensitive detector) should be between 20 mm and 40 mm. The distances of d1 and d2 should be kept the same. The split optical probe is flexible and can fit well on the surface of the human body part during use, ensuring that no ambient light can enter the photosensitive detector, and the photosensitive detector only receives the light returned from human tissues. Since the split optical probe is made of flexible material, it plays a good buffering role for the embolism attack part, reduces the uncomfortable compression feeling, improves the fit with the skin, avoids the interference of ambient light, and improves the monitoring accuracy. The light source and the photosensitive detector are just embedded in the flexible material.

[0050] The main body part of the instrument includes a main control unit module, a second wireless communication module, a power supply circuit module, a data processing module, a data storage module, a data display module, and an alarm module. The main control unit module is used to coordinate and allocate the work of each module and part of the circuit, and can also play a control and guiding function; the second wireless communication module is responsible for receiving the data sent by the first wireless communication module of the split optical probe, and is also responsible for transmitting the relevant processed data to mobile devices such as mobile phones; the power supply circuit module is responsible for supplying power to the entire early thrombus screening instrument system, reducing the noise of the system, and improving the stability of the system; the data acquisition module converts the collected analog signals for convenient analysis and storage.

[0051] The main control unit module, as the control core of the entire system, realizes the following functions: receiving the data sent by the discrete optical probe, and converting the processed data into changes in hemodynamic parameters, such as blood oxygen saturation, etc., via spatial resolved near-infrared spectroscopy or the modified Beer-Lambert law, and storing the data as hemodynamic data; transmitting the calculated data to the data display module in real time for display to the user; monitoring the changes in the user's hemodynamic physiological signals through the calculated data, and immediately sending an alarm signal when reaching the thrombus-related threshold, etc.

[0052] The method for the main control unit module to obtain hemodynamic parameters (blood oxygen saturation) based on the modified Beer-Lambert law is as follows:

[0053] (1) The relationship between the light intensity (OD) and HbO 2 and Hb can be described by the modified Beer-Lambert law as the following equation expression:

[0054]

[0055] where OD represents the light intensity, the subscript symbol γ represents the wavelength of the near-infrared irradiation light, and correspond to the molar extinction coefficients of HbO 2 and Hb at the wavelength value of γ respectively. PLF is the differential path length factor, and d SD represents the symbol of the distance between the near-infrared light source and the photosensitive detector. In clinical experiments, this value is a fixed constant value. C[HbO 2 and C[Hb] represent the magnitude values of the corresponding HbO 2 and Hb at a specific time. This expression can clearly show the stage change amounts of HbO 2 and Hb (corresponding to Δ[HbO 2 and Δ[Hb]) depend on the accuracy of the extinction coefficient ε and the differential path length factor PLF.

[0056] (2) After the near-infrared light enters the human tissue, a part of the light returns after scattering and refraction. By detecting the change in the light intensity of the incident and outgoing light before and after, the change in the optical density (ΔOD, optical density) of the light in the human tissue can be known. Based on the modified Beer-Lambert law, in the case where the absorption coefficient changes little, the relationship between the concentration changes (Δ[o-Hb], Δ[deo-Hb]) of the main substances o-Hb and deo-Hb that cause the attenuation of the light in the tissue and ΔOD is as follows:

[0057]

[0058] ΔOD in Equation (2) 1 and ΔOD 2 respectively represent the changes in optical density of light with two different wavelengths in two weeks; c (c') and v (v') are two sets of coefficients to be determined. It can be seen from Equation (2) that when the blood concentration remains unchanged and the concentration of deoxyhemoglobin is 0, ΔOD 2 and ΔOD 1 are measured respectively, and their ratio will be equal to v / c; the ratio of ΔOD 1 measured in two states where the concentration of deoxyhemoglobin is 0 and the concentration of oxyhemoglobin is 0 respectively is equal to c / c'.

[0059] (3) The ratios of the coefficients to be determined v / c, v' / c' and c / c' can be measured by converting them into ratios of optical density, as shown in the following formula:

[0060]

[0061] (4) Since the changes in oxyhemoglobin and deoxyhemoglobin are the measurement objects, combined with (2) and (3), the conversion formula between ΔOD and Δ[o-Hb], Δ[deo-Hb] is deduced:

[0062]

[0063] where R is related to the optical path differential factor, which is tentatively set to 1 here. Then, through experimental methods, v / c, v' / c' and c / c' are measured according to (3), and the three coefficients in (3) can be calculated. Finally, the relative quantity measurement formula for measuring tissue blood oxygen saturation is obtained through Equation (4).

[0064] The second wireless communication module receives the data sent by the first wireless communication module of the separated optical probe by setting the master-slave mode, and at the same time conducts data transmission and storage with mobile devices such as mobile phones and tablets through transmission methods such as Bluetooth or WIFI.

[0065] The data processing module amplifies, filters, and converts the detected signal from analog to digital, and transmits it to the main control unit module. The original signal collected is a voltage signal representing the attenuation of light intensity.

[0066] The data storage module is connected to the main control unit module and is used to store the data processed by the data processing module in the memory. The memory is divided into two parts, namely the host memory and the extended memory. The extended memory is a USB flash drive, an SD card or other storage media.

[0067] The data display module uses an OLED display screen, which is connected to the main control unit module and is used to display the changes in the human blood dynamic physiological signals processed by the data processing module over time in real time through the OLED screen, providing intuitive blood dynamic physiological parameters of the patient for the user.

[0068] The alarm module uses a buzzer, which is connected to the main control unit module. When the thrombosis attack suspicion index obtained according to the measurement result is greater than the set threshold, an alarm is sent to the user through the buzzer.

[0069] The power supply module includes a wired power supply part and a wireless charging part: The wired power supply part is used to supply power to the main body part of the instrument; The wireless charging part: When the main body of the instrument is not in use, the detachable optical probe can be stored inside the main body part of the instrument. When the two are inductively coupled with each other, the main body part of the instrument supplies power to the detachable optical probe.

[0070] The working principle of the present invention is as follows: The micro-control processor of the detachable optical probe sends a control instruction to the light source driving module. The light source driving module sequentially lights up each wavelength of the multi-wavelength near-infrared light source according to a certain time sequence. The lighting frequency of each wavelength of the near-infrared light source and the luminous power of the near-infrared light source can be adjusted through the light source driving module. The light emitted by the near-infrared light source is incident on the tissue to be measured. The photosensitive detector with a pre-amplification function located on the same side of the near-infrared light source receives the backscattered photons after being absorbed and scattered by the tissue to be measured, converts the optical signal into a voltage signal and performs pre-amplification. The pre-amplified voltage signal and the human physiological signals such as body temperature and pressure touch monitored by the auxiliary monitoring module are sent by the micro-control processor of the detachable optical probe to the first wireless communication module, and the first wireless communication module transmits the signal to the second wireless communication module of the main body part of the instrument. Then the received data is transmitted to the data processing module, amplified, filtered and subjected to high-precision analog-to-digital conversion, and then transmitted to the main control unit module. Then the main control unit module saves the data through the data storage module, and at the same time calculates the data according to the algorithm to obtain the blood dynamic physiological signal parameters of the user, and transmits the measurement result and the auxiliary monitored human physiological signals to the data display module for display and stores them in the data storage module. It can also be transmitted to the mobile phone APP through the second wireless communication module for analysis. At the same time, judge the blood dynamic physiological signal parameters after measurement and processing. If the thrombus-related threshold is reached, an alarm signal is immediately sent and other functions.

[0071] Figure 3The first embodiment of the present invention is given. When monitoring and measuring, the detachable optical probe can be fixed on a special buckle. The user wears the buckle on the middle finger. The detachable optical probe with a curved design can well fit the curve of the human body part, and can realize the function of accurate self-measurement by a single person. During monitoring, the micro-control processor of the detachable optical probe sends a control instruction to the light source driving module, and the light source driving module sequentially lights up each wavelength of the three-wavelength near-infrared light source according to a certain time sequence. The light emitted by the near-infrared light source enters the tissue of the part to be measured, and the photosensitive detector located on the same side of the near-infrared light source receives the backscattered photons after being absorbed and scattered by the tissue of the part to be measured, converts the optical signal into a voltage signal and performs pre-amplification. Then, the voltage signal is sent by the micro-control processor of the detachable optical probe to the first wireless communication module, and the first wireless communication module transmits the signal to the second wireless communication module of the main body of the instrument. After that, the received data is passed to the data processing module, and after amplification, filtering and high-precision analog-to-digital conversion, it is passed to the main control unit module. Then, the main control unit module saves the data through the data storage module, and at the same time calculates the data according to the algorithm, so as to obtain the user's hemodynamic physiological signal parameters, and transmits the measurement result to the data display module for display. This embodiment greatly demonstrates the convenience of the present invention, can meet the usage requirements of users in multiple scenarios, and can accurately and reliably perform non-invasive real-time monitoring of the thrombus condition of any part of the user.

[0072] Figure 4 In the second embodiment of the present invention, when monitoring and measuring, the detachable optical probe can be connected and fixed to the upper end of the main body of the instrument through the upper TYPE-C connection port of the main body of the instrument to form an integrated movable monitoring handle with the optical probe and the main body of the instrument as a whole. The structural diagram of this movable monitoring handle is as Figure 5As shown in the figure. The movable monitoring handle has an optical probe with a radian design, which can well fit the curve radian of the human body part, and can realize the functions of accurate self-test by an individual or measurement by others, and is suitable for the elderly or users with inconvenient hands and feet, and the scenario of measurement by others. During monitoring, the optical probe micro-control processor sends control instructions to the light source driving module, and the light source driving module sequentially lights up each wavelength of the three-wavelength near-infrared light source according to a certain time sequence. The light emitted by the near-infrared light source enters the tissue of the part to be measured, and the photosensitive detector located on the same side of the near-infrared light source receives the backscattered photons after being absorbed and scattered by the tissue of the part to be measured, converts the optical signal into a voltage signal and performs pre-amplification. The separated optical probe is connected to the main body of the instrument through a serial port by wire, and there is no need to start the first wireless communication module. The received data is transmitted to the data processing module, and after amplification, filtering and high-precision analog-to-digital conversion, it is transmitted to the main control unit module. Then the main control unit module saves the data through the data storage module, and at the same time calculates according to the algorithm to obtain the user's hemodynamic physiological signal parameters, and transmits the measurement result to the data display module for display. It can also be transmitted to the mobile phone APP through the second wireless communication module, which is convenient for the family members of users such as the elderly to view and eliminate potential risks.

[0073] It should be emphasized that the embodiments described in the present invention are illustrative rather than restrictive. Therefore, the present invention includes but is not limited to the embodiments described in the specific implementation manners. Any other implementation manners obtained by those skilled in the art according to the technical solutions of the present invention also belong to the scope of protection of the present invention.

Claims

1. A portable non-invasive early thrombosis screening instrument, characterized in that: it includes a separable optical probe and an instrument main body part. The separable optical probe is attached to the skin surface of the user to perform optical detection on this part and transmit the detection data to the instrument main body part. The instrument main body part is used to receive and analyze the data sent by the separable optical probe and display the thrombosis monitoring result obtained from the analysis; the separable optical probe includes a micro-control processor and a near-infrared light source, a photosensitive detector, a light source driving module, and a power supply and charging module connected thereto; the near-infrared light source is used to emit three wavelengths of near-infrared light; the photosensitive detector is used to collect optical signals and convert them into corresponding digital electrical signals for processing; the light source driving module drives the near-infrared light source to work; the micro-control processor controls the light source driving module to sequentially light up the near-infrared light source according to a set time sequence, receive the data collected by the photosensitive detector and transmit it to the instrument host part; the power supply and charging module is responsible for supplying power to the separable optical probe; the instrument main body part includes a main control unit module and a power supply circuit module, a data processing module, a data storage module, and a data display module connected thereto; the power supply circuit module supplies power to the entire early thrombosis screening instrument; the data acquisition module converts the collected analog signals for convenient analysis and storage; the main control unit module is used to receive the data sent by the separable optical probe, convert it into hemodynamic parameter changes by the modified Beer-Lambert law, store the data as hemodynamic data, and transmit the measured data to the data display module in real time to display the detection result; the method for the main control unit module to obtain hemodynamic parameters using the modified Beer-Lambert law is: ⑴ The relationship between the light intensity (OD) and HbO, Hb can be obtained through the modified Beer-Lambert law: OD 2 , Hb both is OD γ : where OD represents the light intensity, and the subscript symbol γ represents the wavelength of the near-infrared irradiation light, and correspond to the molar extinction coefficients of HbO 2 and Hb at the wavelength value of γ, respectively; PLF is the differential path length factor, d SD is the symbol representing the distance between the near-infrared light source and the photosensitive detector, and this value is a fixed constant value. C[HbO 2 and C[Hb] represent the magnitudes of the corresponding HbO 2 and Hb at a specific time; ⑵ Based on the modified Beer-Lambert law, in the situation where the change in the absorption coefficient is relatively small, the relationship between the concentration changes (Δ[o-Hb], Δ[deo-Hb]) of the main substances o-Hb and deo-Hb that cause light attenuation in tissues and ΔOD is: where ΔOD 1 and ΔOD 2 respectively represent the changes in optical density of light with two different wavelengths in two weeks; c, c', v, and v' are two sets of coefficients to be determined. When the blood concentration remains unchanged and the concentration of deoxyhemoglobin is 0, ΔOD 2 and ΔOD 1 are measured respectively, and the ratio of them is equal to v / c; the ratio of ΔOD 1 measured under two states where the concentration of deoxyhemoglobin is 0 and the concentration of oxyhemoglobin is 0 is equal to c / c'; ⑶ The ratios of the undetermined coefficients v / c, v' / c', and c / c' are converted into ratios of optical densities and measured as follows: ⑷ According to ⑵ and ⑶, the conversion formula of ΔOD with respect to Δ[o-Hb] and Δ[deo-Hb] is derived: where R is related to the optical path differential factor, and this value is 1. Then, through experimental methods, v / c, v' / c', and c / c' are measured according to ⑶, and finally, the relative quantity measurement formula for measuring tissue oxygen saturation is obtained through formula ⑷; the separable optical probe further includes an auxiliary monitoring module, and the auxiliary monitoring module includes a temperature sensor, a pressure touch sensor, etc., for detecting human physiological parameters related to the onset of thrombosis; the near-infrared light source emits three wavelengths of near-infrared light under the control of the micro-control processor and driven by the light source driving module; the light source driving module sequentially lights up each wavelength of the multi-wavelength near-infrared light source according to a certain time sequence, and the lighting frequency of each wavelength of the near-infrared light source and the light emission power of the near-infrared light source are regulated by the light source driving module; The wavelength ranges of the three wavelengths of light are: 700nm to 750nm, 750nm to 800nm, and 800nm to 850nm; The separable optical probe is encapsulated together by a flexible material, with the photosensitive detector as the center and two near-infrared light sources arranged in a linear layout around the photosensitive detector. The distance between the centers of the near-infrared light sources and the center of the photosensitive detector is 20mm to 40mm.

2. A portable non-invasive early thrombosis screening instrument according to claim 1, characterized in that: The separable optical probe further includes a first wireless communication module connected to the micro-control processor. The instrument main body part further includes a second wireless communication module connected to the main control unit module. The separable optical probe and the instrument main body part realize data interaction functions through the first communication module and the second communication module. The second communication module also performs data transmission and storage with a mobile phone or a tablet computer through Bluetooth or WIFI transmission.

3. A portable non-invasive early thrombosis screening instrument according to claim 1, characterized in that: The separable optical probe and the instrument main body part are respectively provided with serial communication interfaces connected to the micro-control processor and the main control unit module. The separable optical probe and the instrument main body part realize data interaction functions through the serial communication interfaces.

4. A portable non-invasive early thrombosis screening instrument according to claim 1, characterized in that: The instrument main body part further includes an alarm module connected to the main control unit module. When the measurement result is greater than the set threshold, an alarm is given through the alarm module.

5. A portable non-invasive early thrombosis screening instrument according to any one of claims 1 to 4, characterized in that: The power supply module includes a wired power supply part and a wireless charging part. The wired power supply part is used to supply power to the instrument main body part. When the instrument main body part is not in use, the wireless charging part houses the separable optical probe inside the instrument main body part, and the two are inductively coupled to supply power to the separable optical probe by the instrument main body part.

Images