Quantitative evaluation device for autonomic nerve function

Abstract

A quantitative evaluation device for autonomic nerve functions mainly comprises a control mainboard, an ear clip type heart rate sensor, a rechargeable battery and a human-computer interaction interface. The device has the advantages that the ear clip type heart rate sensor is adopted, two indexes SDNN and LF / HF which are highly related to autonomic nervous functions are screened out and serve as indexes for autonomic nervous function quantitative evaluation, the monitoring device is wearable or portable, and compared with existing heart rate variability monitoring devices, data acquisition is simpler in operation and lower in cost; and the application scene of the medical equipment is greatly expanded.

Description

Technical Field

[0001] The present disclosure relates to a device for quantitatively evaluating autonomic nerve function, belonging to the monitoring and evaluation equipment for human health status, and is for use in medical institutions, psychological rehabilitation institutions or families. Background Art

[0002] The autonomic nervous system (ANS), also known as the vegetative nervous system, is independent of the brain and conscious control and can automatically regulate the functions of the human body. The ANS is divided into the sympathetic nervous system and the parasympathetic nervous system. Under normal or stress conditions, the autonomic nervous system plays an important role in maintaining the cardiovascular system, gastrointestinal tract and body temperature homeostasis of the body. Disorders of autonomic nerve function can cause various diseases such as headache, sinus tachycardia, sleep disorders and depression.

[0003] Heart rate variability parameters have been widely used clinically as indicators for evaluating cardiovascular health. At the same time, it has been found that the time variation between heartbeats reflected by the heartbeat is caused by the regulation of the autonomic nervous system on the heart. Analyzing heart rate variability parameters mathematically can objectively reflect the measure of the interaction between the heart and the brain and evaluate the state of the human autonomic nervous system. The heart rate variability examination equipment commonly used in medical institutions usually requires 5-12 electrodes, and there are professional technical specifications for the fixed positions of the electrodes on the human body, detection methods, etc., and the price is expensive, so it is difficult to be effectively popularized and applied in places such as psychological institutions, communities and families. The single-channel earclip-type heart rate sensor adopted in the embodiments of the present disclosure has a simpler structure and is also very simple to operate. It only needs to be clipped on the earlobe position of the patient to dynamically collect heart rate information, and the heart rate variability parameters of the patient can be calculated through an open-source dedicated analysis software, providing a quantitative evaluation device for autonomic nerve function with objectivity and quantifiability, aiming to solve the deficiencies of the prior art. Summary of the Invention

[0004] The present disclosure provides a device for quantitatively evaluating autonomic nerve function, mainly including a control main board, an earclip-type heart rate sensor, a rechargeable battery and a human-computer interaction interface.

[0005] The control main board is an integrated circuit developed based on a core processor. The control main board includes a signal processing module, a power management module, a storage module and a communication module, etc. Among them, the core processor uses a microprocessor (also known as a single-chip microcomputer, MCU), and an embedded software is burned in the storage module of the control main board.

[0006] The embedded software is mainly used for controlling the driving of main board electronic components, executing operation instructions, signal calculation and processing, power management, information output, etc. Further, an algorithm for heart rate variability parameters is provided in the embedded software, and the algorithm for heart rate variability parameters adopts the international standard of "Measurement, Physiological Significance and Clinical Application of Heart Rate Variability", which was publicly released and open source by the European Society of Cardiology and the North American Society of Pacing and Electrophysiology in 1996.

[0007] The described ear clip type heart rate sensor mainly consists of two light emitting diodes, a photomultiplier tube, a fixing device, a silica gel gasket, a lead wire and a quick connector, where:

[0008] The two light emitting diodes adopted by the ear clip type heart rate sensor, one of which emits visible red light with a wavelength of 650nm ± 10nm, and the other light emitting diode emits invisible infrared light with a wavelength between 930nm ± 10nm.

[0009] The photomultiplier tube adopted by the ear clip type heart rate sensor is a photosensitive vacuum electron device that converts extremely weak light signals into electrical signals. The monitoring range of the photomultiplier tube is not less than a wavelength of 500nm - 1000nm. The photomultiplier tube is a photoelectric conversion device based on the external photoelectric effect, and has the advantages of high gain, low noise and high frequency, and can convert extremely low energy light signals into electrical signals.

[0010] The fixing device is a clip made of polymer material and capable of fixing on the patient's earlobe, usually consisting of two clip pieces that can be opened and closed left and right, a pin and a spring. The external shape of the fixing device is not limited, and it is preferably in line with the ergonomic structure.

[0011] The two light emitting diodes and a photomultiplier tube are respectively encapsulated in the central positions of the two clip pieces of the fixing device, and the light emitting windows of the two light emitting diodes face the monitoring window of the photomultiplier tube.

[0012] In order to increase the comfort of the fixing device when clipped on the patient's earlobe, a silica gel gasket is provided on the outer periphery of the two light emitting diodes and a photomultiplier tube, and the silica gel gasket is arranged on the inner sides of the two clip pieces of the fixing device.

[0013] The described lead wire is used for signal transmission between the ear clip type heart rate sensor and the control main board. The adopted lead wire is a 5-core shielded wire, which is respectively connected to the power supply ends and signal end interfaces of the two light emitting diodes and a photomultiplier tube.

[0014] The end of the lead wire is provided with a quick connector, which can be a 5-core aviation connector or a Type-C connector, and is used to connect the lead wire to the control main board.

[0015] The rechargeable battery is used to provide working power for components such as the control main board, and can be 2 or 4 18650 nickel-metal hydride batteries.

[0016] The display module of the human-machine interaction interface uses a 4.3-inch liquid crystal display screen, the warning device uses a conventional buzzer, the operation function keys use button-type electronic buttons, and the protective shell is injection-molded with ABS material.

[0017] The feature of this disclosure is the use of an earclip-type heart rate sensor, which is used to fix and dynamically collect electrocardiogram signals at the earlobe of the patient, and the collection time is 5-10 minutes each time. The earclip-type heart rate sensor uses photoplethysmography to collect the intervals (RR intervals) and heart rates (HR) of the heartbeat in real time, and inputs them into the control main board through the lead wire. After signal amplification, filtering, and AD conversion, the heart rate variability data is calculated through the heart rate variability algorithm in the embedded software. Then, among the calculated heart rate variability data, the indicators with a strong correlation with the autonomic nerve function are selected as the indicators for quantitative evaluation of the autonomic nerve function.

[0018] There are many indicators used clinically to evaluate cardiovascular health. The commonly used heart rate variability parameters include frequency domain indicators and time domain indicators. Among them, the frequency domain indicators include TP, HF, LF, VLF, LF%, HF%, LF / HF, and the time domain indicators include M-HRT, SDNN, SDANN, rMSSD, etc. According to clinical research, this disclosure selects two indicators with a strong correlation with the autonomic nerve function: the heart rate variability parameters SDNN and LF / HF are used as the indicators for quantitative evaluation of the autonomic nerve function.

[0019] SDNN: It is the standard deviation of all NN intervals (all sinus rhythm R-R intervals, and the R-R interval is the time between the R waves in two QRS waves), and the unit is ms (millisecond). SDNN is used to reflect the magnitude of the patient's heart rate variability and judge the state of the patient's autonomic nerve function. Taking 141±39ms as the standard threshold, when SDNN is higher than the standard threshold, it indicates that the patient has a higher autonomic nerve activity and a higher state of psychological resilience; on the contrary, when SDNN is lower than the normal range, it indicates that the patient has a poor autonomic nerve activity and a lower state of psychological resilience.

[0020] LF / HF is the spectral energy ratio of low-frequency power (spectrum of 0.04 - 0.15 Hz) and high-frequency power (spectrum of 0.15 - 0.4 Hz). The LF / HF ratio is used to reflect the balance state of the autonomic nervous system and represents the level of sympathetic nerve tension. Taking 1.5 - 2.0 as the standard threshold, the larger the LF / HF ratio, the higher the balance state of the patient's autonomic nervous system and the stronger the self-regulation ability; conversely, the lower the LF / HF ratio, the lower the balance state of the patient's autonomic nervous system and the weaker the self-regulation ability.

[0021] The beneficial effects of the present disclosure are as follows:

[0022] On the one hand, a set of medical devices for collecting patients' heart rate variability data at the earlobe part is provided. By using a photomultiplier tube to obtain the heart rate signal, it not only has lower working power consumption and higher collection sensitivity, enabling the monitoring device to be wearable or portable, but also the data collection is simpler and the cost is lower than that of existing heart rate variability monitoring devices, greatly expanding the application scenarios of medical devices. At the same time, due to the rich blood vessels and blood flow and thin skin at the earlobe part of the human body, the individual differences between different humans are small, and the stability and consistency of the collected data are better than those of the existing technical solutions.

[0023] On the other hand, two indicators SDNN and LF / HF with strong correlations with autonomic nerve function are selected as the indicators for quantitative evaluation of autonomic nerve function, making professional medical data more understandable, and providing an objective and quantifiable tracking and evaluation tool for psychological institutions, communities or home monitoring, which has good clinical significance and application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 is the circuit schematic diagram of the embodiment of the present disclosure

[0025] Figure 2 is the overall structure schematic diagram of the embodiment of the present disclosure

[0026] Figure 3 is a circuit diagram of the earclip-type heart rate sensor of the embodiment of the present disclosure

[0027] As shown in the figure: host (1), quick connector (2), lead wire (3), earclip (4), light-emitting diode with a wavelength of 650 nm ± 10 nm (5), light-emitting diode with a wavelength of 930 nm ± 10 nm (6), photomultiplier tube (7) DETAILED DESCRIPTION OF THE EMBODIMENTS

[0028] The present disclosure will be specifically described below in conjunction with the drawings and embodiments.

[0029] Embodiment: An example of the preparation method of a device for quantitative evaluation of autonomic nerve function

[0030] 1. Design and production of the control main board

[0031] The control main board is an integrated circuit developed based on a microcontroller (MCU), including general components such as a signal processor, a memory, a power management module, a WiFi / Bluetooth communication module, etc.

[0032] The model of the microcontroller used is STC89C52, produced by STC Company.

[0033] The communication module is used for the communication between the host of the present disclosure and the PC, iPad or mobile phone. The communication module uses a WiFi module with the model QCA9377, produced by Qualcomm.

[0034] Design the schematic diagram and PCB layout, and produce the control main board according to the traditional electronic chip mounting process.

[0035] 2. Design and production of the earclip-type heart rate sensor

[0036] According to Figure 3 Design the PCB circuit according to the shown circuit diagram. The earclip-type heart rate sensor is constructed by two light-emitting diodes, a photomultiplier tube and an earclip. Among them, one light-emitting diode emits visible red light with a wavelength of 650nm, and the other light-emitting diode emits invisible infrared light with a wavelength between 930nm.

[0037] The earclip is prepared by injection molding with medical polyvinyl chloride material. The two light-emitting diodes are located on one side of the earclip, and the photomultiplier tube is located on the other side of the earclip. And the two light-emitting diodes and the photomultiplier tube are arranged face to face on the same horizontal line. The peripheries of the two light-emitting diodes and the photomultiplier tube are connected and sealed with the earclip by silica gel.

[0038] 3. Production of the protective shell

[0039] The protective shell is made by injection molding with ABS material. There is a socket on the side of the protective shell for connecting the earclip-type heart rate sensor and the control main board.

[0040] 4. Product assembly

[0041] Install the control main board in the protective shell and fix it with screws.

[0042] The earclip-type heart rate sensor is connected and communicates with the control main board by a lead wire, and the connection method is to use a 6-core aviation plug.

[0043] The display module of the human-computer interaction interface uses a 4.3-inch liquid crystal display screen, and the operation function keys use button-type electronic buttons.

[0044] The above-mentioned drawings and embodiments are only used to illustrate the technical solutions of the present disclosure rather than to limit them. Although the present disclosure has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that the technical solutions of the present disclosure can be modified or equivalently replaced without departing from the spirit and scope of the technical solutions of the present disclosure, and they should all be covered within the scope of the claims of the present disclosure, without constituting any limitation to the protection scope of the present disclosure.

Claims

1. A quantization evaluation device for autonomic nerve function mainly includes a control main board, an earclip-type heart rate sensor, a rechargeable battery, and a human-computer interaction interface, and is characterized in that: The control main board is an integrated circuit developed based on a core processor. The earclip - type heart rate sensor mainly consists of two light - emitting diodes, a photomultiplier tube (7), a fixing device, a silica gel gasket, a lead wire (3) and a quick connector (2). The fixing device is a clip made of a polymer material and can fix on the patient's earlobe. The lead wire (3) is used for signal transmission between the earclip - type heart rate sensor and the control main board. The earclip - type heart rate sensor is used to fix on the patient's earlobe and dynamically collect electrocardiogram signals, and the collection time is 5 - 10 minutes each time.

2. The quantitative evaluation device for autonomic nerve function according to claim 1, characterized in that: Among the two light - emitting diodes used, one emits visible red light with a wavelength of 650nm ± 10nm, and the other emits invisible infrared light with a wavelength between 930nm ± 10nm.

3. The quantitative evaluation device for autonomic nerve function according to claim 1, characterized in that: The photomultiplier tube (7) used is a photosensitive vacuum electron device that converts extremely weak light signals into electrical signals. The monitoring range of the photomultiplier tube (7) is not less than wavelengths from 500nm to 1000nm.

4. The quantitative evaluation device for autonomic nerve function according to claim 1, characterized in that: The fixing device is a clip made of a polymer material and can fix on the patient's earlobe.

5. The quantitative evaluation device for autonomic nerve function according to claim 1, characterized in that: The two light - emitting diodes and a photomultiplier tube (7) are respectively encapsulated at the center positions of the two clip pieces of the fixing device, and the light - emitting windows of the two light - emitting diodes face the monitoring window of the photomultiplier tube (7).

6. The quantitative evaluation device for autonomic nerve function according to claim 1, characterized in that: The SDNN is used to reflect the magnitude of the patient's heart rate variability and judge the state of the patient's autonomic nerve function, with a standard threshold of 141 ± 39ms.

7. A quantification and evaluation device for autonomic nerve function according to claim 1, characterized in that: The LF / HF ratio is used to reflect the balance state of the autonomic nervous system, representing the level of sympathetic nerve tension, with a standard threshold of 1.5 - 2.0.

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