WO2023000153A1 - Integrated electrophysiological signal recording and processing system - Google Patents

Abstract

The present invention relates to the technical field of medical instruments, and in particular, to an integrated electrophysiological signal recording and processing system. The integrated electrophysiological signal recording and processing system comprises a patient coupling unit and an embedded SoM computing unit, which are characterized in that an input end of the patient coupling unit is connected to several external signals, the patient coupling unit and the embedded SoM computing unit are bidirectionally connected to each other, and an output end of the embedded SoM computing unit is connected to a display. In comparison with the prior art, an integrated electrophysiological signal recording and processing system is provided, in which system a patient interface unit and an electrophysiological signal amplification unit in an existing electrophysiological system are combined to form a patient coupling unit having a signal conditioning function, thereby reducing the number of interconnected devices in the existing electrophysiological system without reducing the performance of the system; and a communication cable and a power supply cable are combined by using PoE technology, thereby simplifying the connection between the devices.

Description

An integrated electrophysiological signal recording and processing system technical field

The invention relates to the technical field of medical equipment, in particular to an integrated electrophysiological signal recording and processing system.

Background technique

Modern medicine usually uses radiofrequency ablation to treat diseases such as atrial fibrillation and atrial flutter caused by abnormal electrical activity of the heart. Abnormal electrical activity within the patient's heart must be identified prior to treatment. At present, the identification of abnormal electrical activity in the heart is mainly completed by a multi-channel electrophysiological recording system. The operator passes the dedicated medical catheter through the patient's venous or arterial system, and the head end of the medical catheter finally reaches the patient's atrium or ventricle, and the intracardiac electrical activity signal (ie, cardiac electrophysiological signal) is detected by the electrode at the catheter head. The cardiac electrophysiological signals collected by the electrodes are amplified and adjusted through the equipment connected with the catheter, and then transmitted to the computer, which is further processed by the software in the computer and displayed as intracardiac electrophysiological signals with diagnostic significance. active waveform. The operator judges the abnormal electrical signal conduction pathway in the heart by analyzing the above electrical activity waveforms, and uses a special medical catheter to perform radiofrequency ablation for the purpose of treatment.

Among the existing disclosed products and technical solutions, a representative example is a multi-channel electrophysiological recording system with a mapping function disclosed by St. Jude Company of the United States, as shown in Figure 1. Its main It consists of three devices: 1. Amplifier, used to amplify and adjust the electrophysiological signal from the patient; 2. Display workstation, composed of a general computer system, used to communicate with the amplifier and display the waveform of electrical activity in the heart; 3. Patient connection module for electrical coupling between the patient and the amplifier. These three devices independently obtain power from the mains interface, and the devices are connected to each other with communication cables for communication. Another example is the LEAD multi-channel electrophysiological recorder disclosed by Sichuan Jinjiang Electronic Technology Co., Ltd., which is also composed of the above three devices and has a similar system structure.

It can be found that in the existing products and technical solutions, three devices with different functions need to be used to work together, and the reliability and stability of the entire system are somewhat lower than that of a single device. Assuming that under normal use and maintenance conditions, the failure rate of a single device is 5%, the probability that the amplifier, display workstation, and patient connection module will work normally at the same time is only 85.7%, which reduces the overall efficiency of the unit using the device. At the same time, the three types of equipment and patients are connected through power cables and communication cables respectively. The connections are often complicated and are more likely to cause failures due to poor cable connections. The operation of analyzing and troubleshooting brings difficulties. It is often necessary for the manufacturer to send professionals to the site for repairs. If the repairs cannot be completed on site, the equipment user needs to pay high logistics and price guarantee fees, and send it back to the manufacturer for repairs, which greatly Increase the maintenance cost of the unit using the equipment. In terms of the use environment of the equipment, due to the presence of other large equipment, such as X-ray machines, C-arms, etc., the electromagnetic disturbance and ionizing radiation generated by them will affect the communication between the equipment, and may also shorten the life of the electronic components inside the equipment, reducing the its reliability. Furthermore, since the equipment is powered by an independent AC mains, there is a risk of electric shock to the patient in a single fault state, such as when the protective grounding wire is disconnected, and there is a risk of micro-electric shock when there is no equipotential grounding. At the same time, the above three types of equipment occupy a large volume and weight, and require special trolleys for support and movement, which is not conducive to equipment sharing among operating rooms and reduces the utilization rate of high-value equipment.

From the analysis of typical scenarios of clinical use of existing equipment, patients with abnormal ECG usually receive unified diagnosis and treatment in the interventional ward or catheterization room of the hospital. Similar to other inpatients in the hospital, patients in the interventional ward also need the continuous monitoring of basic vital signs, such as electrocardiogram, fingertip blood oxygen saturation, non-invasive blood pressure and other parameters. At the same time, due to the large number of patients, medical staff usually have to monitor them in the form of a nurse station, but this kind of monitoring has problems such as low communication reliability and delay in information feedback, which brings some inconvenience to patient life monitoring, and even Security risks.

According to the above analysis, there is still a lack of a highly integrated electrophysiological signal recording system in the field of electrophysiology, which can not only reduce the size of the equipment, but also simplify the connection between equipment, integrate patient monitoring functions, and integrate distributed monitoring and diagnostics to enhance the safety, availability, reliability and connectivity of such devices.

Contents of the invention

In order to overcome the deficiencies of the prior art, the present invention provides an integrated electrophysiological signal recording and processing system, which combines the patient interface unit and the electrophysiological signal amplification unit in the existing electrophysiological system to form a signal conditioning system. The patient coupling unit reduces the number of interconnected devices in the system without reducing the performance of the existing electrophysiological system; uses PoE technology to combine communication cables and power supply cables to simplify the connection between devices.

In order to achieve the above purpose, an integrated electrophysiological signal recording and processing system is designed, including a patient coupling unit and an embedded SoM computing unit. The SoM computing unit is bidirectionally connected, and the output terminal of the embedded SoM computing unit is connected to the display; the patient coupling unit includes a shell, a main panel, a clamp protection circuit, a signal conditioning circuit, a left panel, a power supply and communication circuit, and a right side panel. Panel, non-invasive blood pressure detection circuit and blood oxygen saturation detection circuit. The shell is in the shape of a rectangular parallelepiped, and a clamp protection circuit, signal conditioning circuit, power supply and communication circuit are arranged inside the shell, and the clamp protection circuit, signal The conditioning circuit, power supply and communication circuit are separated and arranged through the circuit board guide rails on the left and right sides inside the housing. The main panel is embedded on the top of the housing, and the front and rear ends of the housing are respectively connected to the left panel and the right panel. One side of the circuit is provided with a noninvasive blood pressure detection circuit and a blood oxygen saturation detection circuit; the embedded SoM computing unit includes an upper cover, a power module, a computing unit main board, a bottom board, a left side board, and a right side board, and the The base plate is U-shaped structure, the upper part of the base plate is connected to the upper cover plate, the calculation unit main board is located inside between the base plate and the upper cover plate, and the upper side of the calculation unit main board is equipped with a power module, which is located at the front and rear ends of the base plate respectively. Connect the left and right panels.

The main panel of the patient coupling unit is provided with an intracardiac signal input interface; one side of the shell is provided with operation buttons; the left panel is respectively provided with a body surface ECG signal input interface, a blood oxygen saturation signal input interface, Non-invasive blood pressure measurement interface, invasive blood pressure signal input interface; channel expansion interface, analog output interface, RS-232 communication interface, power supply communication interface are respectively located on the right panel.

The left side board of the embedded SoM computing unit is provided with HDBT interface and Ethernet interface with PoE function respectively, and a cooling fan is embedded on the left side board of HDBT interface and Ethernet interface with PoE function. The said right board is provided with HDMI interface and USB interface respectively, and the power interface and switch are embedded on the right board located at one side of HDMI interface and USB interface.

The clamp protection circuit, signal conditioning circuit, power supply and communication circuit, non-invasive blood pressure detection circuit and blood oxygen saturation detection circuit inside the patient coupling unit are equipped with several functional modules, and the several functional modules include amplifiers, multiple Road switch, high-speed ADC, low-speed ADC, I/V sampler, stimulus releaser, programmable logic array and digital signal processor, Ethernet communication module, I/O device, serial port hub, NIBP module, _SpO2 module, heart The internal signal input interface and the body surface ECG signal input interface are respectively connected to one end of amplifier 1 and amplifier 2 through a clamp protection circuit, the other end of amplifier 1 and amplifier 2 is connected to one end of a multi-way switch, and the other end of the multi-way switch is connected to a high-speed ADC One end of one; the invasive blood pressure signal input interface is connected to one end of the low-speed ADC; the other end of the high-speed ADC and the low-speed ADC is connected to the programmable logic array and the digital signal processor through the electrical isolation interface one; the blood oxygen saturation signal input interface is connected to the electrical Isolation interface-connects one end of the NIBP module, the non-invasive blood pressure measurement interface connects one end of the _SpO2 module through the electrical isolation interface-connection, and the other end of the NIBP module and the _SpO2 module is connected to the serial port hub; the connection programmable logic array and digital signal processing The device is bidirectionally connected with the serial port hub, Ethernet communication module and I/O equipment; the Ethernet communication module is connected with the power supply communication interface through the second connection of the electrical isolation interface; the output terminal connected to the programmable logic array and the digital signal processor is divided into two , one end of the high-speed DAC is connected to one end of the high-speed DAC through the electrical isolation interface 2, and the other end of the high-speed DAC is connected to the analog output interface; The internal signal input interface is connected to the amplifier 2; the other is connected to one end of the I/V sampler, the other end of the I/V sampler is connected to one end of the high-speed ADC 2, and the other end of the high-speed ADC 2 is connected to the serial port hub through the electrical isolation interface 1.

The power supply communication interface is connected to the power bus through the PoE power supply.

The RS-232 communication interface is connected with the serial hub.

The NIBP module is a serial port hub connected to a non-invasive blood pressure measurement module.

The SpO ₂ module is a blood oxygen saturation module.

The computing unit motherboard inside the embedded SoM computing unit is provided with SoM module, HDBT driver, SATA interface, medical AC-DC converter, low-voltage power converter, PoE driver, is provided with coding logic module in SoM module, power supply There is a power manager in the module, and the 220V AC power supply is connected to the coding logic module, low-voltage power converter and PoE driver through the medical AC-DC converter; the Ethernet interface with PoE function is connected to the PoE driver bidirectionally; the PoE driver is connected to the PoE driver. The SoM module is bidirectionally connected; the SoM module is bidirectionally connected to the power manager in the power module; the encoding logic module in the SoM module is connected to the SATA interface, HDMI interface, and USB interface respectively, and the SATA interface is bidirectionally connected to the hard disk; the encoding logic in the SoM module The module is connected with the HDBT interface through the HDBT driver.

The electrophysiological signal recording and processing system is connected to the central station through the HDBT interface inside the embedded SoM computing unit, and the central station is connected to the PC end of the external network through a transmission link.

Compared with the prior art, the present invention provides an integrated electrophysiological signal recording and processing system, which combines the patient interface unit and the electrophysiological signal amplification unit in the existing electrophysiological system to form a patient signal conditioning function. The coupling unit reduces the number of interconnected devices in the system without reducing the performance of the existing electrophysiological system; uses PoE technology to combine communication cables and power supply cables to simplify the connection between devices.

The system is powered by a low-voltage DC power supply, which reduces the risk of electric shock to patients in a single fault state; the computing unit uses an embedded SoM as the core, which not only can be made very small in size, but also has abundant peripheral equipment resources, and does not require other redundant Auxiliary devices such as adapters can drive multiple display devices; it is convenient for device sharing, device transfer and remote deployment.

Description of drawings

FIG. 1 is a schematic diagram of functional modules of an existing medical electrophysiological signal recording device.

Fig. 2 is a schematic diagram of functional modules of the electrophysiological signal recording device of the present invention.

Fig. 3 is an exploded schematic diagram of the structure of the patient coupling unit in the present invention.

Fig. 4 is a structural front view of the patient coupling unit in the present invention.

Fig. 5 is a top view of the structure of the patient coupling unit in the present invention.

Fig. 6 is a left view of the structure of the patient coupling unit in the present invention.

Fig. 7 is a right view of the structure of the patient coupling unit in the present invention.

Fig. 8 is a schematic diagram of the functional modules of the patient coupling unit in the present invention.

FIG. 9 is a schematic exploded view of the structure of the embedded SoM computing unit in the present invention.

Fig. 10 is a structural front view of the embedded SoM computing unit in the present invention.

FIG. 11 is a top view of the structure of the embedded SoM computing unit in the present invention.

Fig. 12 is a rear view of the structure of the embedded SoM computing unit in the present invention.

Fig. 13 is a left view of the structure of the embedded SoM computing unit in the present invention.

Fig. 14 is a right view of the structure of the embedded SoM computing unit in the present invention.

FIG. 15 is a schematic diagram of functional modules of the embedded SoM computing unit in the present invention.

Fig. 16 is a structural diagram of sending data in a distributed manner and realizing real-time multi-party consultation.

Refer to Figure 3 to Figure 7, 1 is the channel expansion interface, 2 is the analog output interface, 3 is the RS-232 communication interface, 4 is the power supply communication interface, 5 is the operation button, 6 is the heart signal input interface, 7 is the body surface ECG signal input interface, 8 is the blood oxygen saturation signal input interface, 9 is the non-invasive blood pressure measurement interface, 10 is the invasive blood pressure signal input interface, 11 is the main panel, 12 is the clamp protection circuit, 13 is the signal conditioning circuit, 14 15 is a power supply and communication circuit, 16 is a circuit board guide rail, 17 is a shell, 18 is a noninvasive blood pressure detection circuit and a blood oxygen saturation detection circuit, and 19 is a right side panel.

Referring to Figures 9 to 12, 20 is the HDMI interface, 21 is the USB interface, 22 is the power interface and switch, 24 is the HDBT interface, 25 is the Ethernet interface with PoE function, 26 is the cooling fan, 27 is the upper cover, 28 is a power supply module, 29 is a computing unit main board, 30 is a bottom board, 31 is a left side board, and 32 is a right side board.

detailed description

The present invention will be further described below according to the accompanying drawings.

As shown in Figure 2, the input of the patient coupling unit is connected to several external signals, the patient coupling unit is bidirectionally connected to the embedded SoM computing unit, and the output of the embedded SoM computing unit is connected to the display.

As shown in Figures 3 to 7, the patient coupling unit includes a housing, a main panel, a clamp protection circuit, a signal conditioning circuit, a left panel, a power supply and communication circuit, a right panel, a noninvasive blood pressure detection circuit and a blood oxygen Saturation detection circuit, the shell 17 has a rectangular parallelepiped cylindrical structure, and the inside of the shell 17 is provided with a clamp protection circuit 12, a signal conditioning circuit 13, a power supply and communication circuit 15, and a clamp protection circuit 12, a signal conditioning circuit 13 , power supply and communication circuits 15 are spaced and arranged through the circuit board guide rails 16 on the left and right sides inside the housing 17, and the main panel 11 is embedded on the top of the housing 17, and the front and rear ends of the housing 17 are respectively connected to the left side panel 14 and the right side Panel 19; a noninvasive blood pressure detection circuit and a blood oxygen saturation detection circuit 18 are provided on one side of the signal conditioning circuit 13; an intracardiac signal input interface 6 is provided on the main panel 11 of the patient coupling unit; Operation buttons 5; located on the left panel 14 are respectively equipped with body surface ECG signal input interface 7, blood oxygen saturation signal input interface 8, non-invasive blood pressure measurement interface 9, and invasive blood pressure signal input interface 10; located on the right panel 19 There are channel expansion interface 1, analog output interface 2, RS-232 communication interface 3, and power supply communication interface 4 respectively.

As shown in Figure 8, the clamping protection circuit 12, the signal conditioning circuit 13, the power supply and communication circuit 15, the noninvasive blood pressure detection circuit and the blood oxygen saturation detection circuit 18 inside the patient coupling unit are provided with several functional modules. Several functional modules include amplifiers, multi-way switches, high-speed ADCs, low-speed ADCs, I/V samplers, stimulus distributors, programmable logic arrays and digital signal processors, Ethernet communication modules, I/O devices, serial hubs, NIBP Module, _SpO2 module, intracardiac signal input interface 6, and body surface ECG signal input interface 7 are respectively connected to one end of amplifier 1 and amplifier 2 through a clamp protection circuit, and the other end of amplifier 1 and amplifier 2 is connected to one end of a multi-way switch. The other end of the multi-way switch is connected to one end of the high-speed ADC 1; the invasive blood pressure signal input interface 10 is connected to one end of the low-speed ADC; the other end of the high-speed ADC 1 and the low-speed ADC are connected to the programmable logic array and the digital signal processor through the electrical isolation interface 1 The blood oxygen saturation signal input interface 8 is connected to one end of the NIBP module through the electrical isolation interface one, the non-invasive blood pressure measurement interface 9 is connected to one end of the _SpO2 module through the electrical isolation interface one, and the other end of the NIBP module and the _SpO2 module is connected to the serial port hub; The described connection programmable logic array and the digital signal processor are respectively connected to the serial hub, the Ethernet communication module and the I/O equipment bidirectionally; the Ethernet communication module is connected to the power supply communication interface 4 through the electrical isolation interface 2; the connection can be programmed The output terminals of the logic array and the digital signal processor are divided into two channels, one is connected to one end of the high-speed DAC through the electrical isolation interface 2, and the other end of the high-speed DAC is connected to the analog output interface 2; the other is connected to one end of the stimulus distributor through the electrical isolation interface 1 , the other end of the stimulus distributor is divided into two paths, one path is connected to the intracardiac signal input interface 6 and the amplifier two; the other path is connected to one end of the I/V sampler, and the other end of the I/V sampler is connected to one end of the high-speed ADC two, The other end of the high-speed ADC 2 is connected to the serial port hub through the electrical isolation interface 1.

The power supply communication interface 4 is connected to the power bus through a PoE power supply.

The RS-232 communication interface 3 is connected with the serial hub.

The model of amplifier one can be AD822; the model of amplifier two can be LT1468 or LT1469; the model of multi-channel switch can be ADG1206 or ADG1208; the model of high-speed ADC one can be AD7634; the model of low-speed ADC can be AD7195; programmable logic array The model of the programmable logic array in the digital signal processor can be Spartan-6 series, the model of the digital signal processor can be TMS320C6748; the model of the I/V sampler can be LTC2351; the model of the high-speed DAC can be AD5623; the serial port The model of the hub can be TL16CP754; the model of the Ethernet communication module can be LAN8710Ai; the model of the stimulus transmitter can be AD7391 high-speed ADC-the model can be AD5623.

The NIBP module is a serial port hub connected to a non-invasive blood pressure measurement module, and its model can be Advantage+.

The SpO ₂ module is a blood oxygen saturation module, and its model can be MSX2040.

As shown in Figures 9 to 14, the embedded SoM computing unit includes an upper cover, a power supply module, a computing unit main board, a bottom board, a left side board, and a right side board. Connected to the upper cover 27, the calculation unit main board 29 is arranged inside between the base plate 30 and the upper cover 27, and the upper side of the calculation unit main board 29 is provided with a power module 28, and the front and rear ends of the base plate 30 are respectively connected to the left side Plate 31 and right side plate 32.

The left side plate 31 of the embedded SoM computing unit is respectively provided with HDBT interface 24, Ethernet interface 25 with PoE function, and is located on the left side plate 31 of HDBT interface 24, the Ethernet interface 25 side with PoE function. There is a cooling fan 26; the right panel 32 is provided with an HDMI interface 20 and a USB interface 21 respectively, and a power interface and a switch 22 are embedded on the right panel 32 at one side of the HDMI interface 20 and the USB interface 21.

As shown in Figure 15, the computing unit motherboard 29 inside the embedded SoM computing unit is provided with SoM module, HDBT driver, SATA interface, medical AC-DC converter, low-voltage power converter, PoE driver, is provided with encoding Logic module, the power supply module 28 is equipped with a power manager, and the AC power supply of 220V is connected to the encoding logic module, low-voltage power converter and PoE driver through the medical AC-DC converter; the Ethernet interface 25 with PoE function is connected to the PoE driver Two-way connection; two-way connection between PoE driver and SoM module; two-way connection between SoM module and power manager in power supply module 28; coding logic module in SoM module is connected with SATA interface, HDMI interface 20, USB interface 21 respectively, SATA interface and hard disk Two-way connection; the coding logic module in the SoM module is connected with the HDBT interface 24 through the HDBT driver.

The model of SoM module can be Jetson TX2; the model of HDBT driver can be LT86104 and KSZ9897, the model of medical AC-DC converter can be NGB250 series, the model of low-voltage power converter can be TPS62140, JHM1012, the model of PoE driver can be Ag5300.

As shown in Figure 16, the electrophysiological signal recording and processing system is connected to the central station through the HDBT interface 24 inside the embedded SoM computing unit, and the central station is connected to the PC terminal of the external network through a transmission link.

The system of the present invention includes two cooperating units. Among them, the patient coupling unit with signal conditioning function achieves electrical coupling with the patient via body surface lead wires, internal catheter electrodes or other media, and collects various analog electrical signals with physiological and diagnostic significance from the patient's body. And through the optimized signal conditioning circuit, the collected analog electrical signal is converted into a digital signal, and passed to the embedded SoM (System- on-Module, the computing unit of the system module). The computing unit based on the embedded SoM draws power from its power supply subsystem, provides power to the PoE driver, and provides power to the patient coupling unit with signal conditioning through the network cable. The computing unit based on the embedded SoM further processes the received digital signal, transmits it through one or more digital video ports, and displays it on one or more general-purpose or special-purpose display devices for the operator to analyze and diagnose.

This highly integrated multifunctional medical electrophysiological signal recording device has the characteristics of small size, stable operation, and low failure rate, which can reduce the space occupation in the operating room and improve the overall efficiency of cardiac interventional operations. At the same time, this highly integrated multi-functional medical electrophysiological signal recording device provides a technical solution for remote deployment of operating room equipment, that is, the above-mentioned multiple computing units based on embedded SoM can be connected through a wired network or wireless network located in the hospital. The network establishes a data connection with the central station that is also located in the hospital, and the central station is connected to the network outside the hospital through a wired or wireless network port. By checking the data sent by the central station in the hospital, the remote medical staff can diagnose and conduct multi-party consultation on patients in the hospital in real time, as shown in Figure 16.

Compared with the existing medical electrophysiological recording system, this embodiment only includes two devices, the patient coupling unit with signal conditioning function and the computing unit based on the embedded SoM, and only one network cable is used for connection between the two devices, greatly The existing connection method is simplified; in terms of power supply, the power supply is converted into DC low-voltage power by the computing unit based on the embedded SoM, and then provided to the patient coupling unit with signal conditioning function, compared with the existing medical electrophysiological recording system. The independent power supply mode is safer; in terms of appearance, the size and weight of the existing medical electrophysiological recording system are greatly reduced. The weight of the whole device is less than 6kg, which is convenient for transportation, storage and use.

FIG. 8 is a schematic diagram of hardware function modules of the patient coupling unit with signal conditioning function of the present invention. The electrocardiographic signal collected from the patient's body surface and the intracardiac electrical signal collected from the catheter in the body are respectively coupled to the amplifier through the special interface on the coupling unit shell for amplification. The protection circuit ensures that the amplifier works in the linear region and protects its Protected from damage from potentially disruptive energy, such as defibrillation energy that might be present on the patient's body. The protection circuit mentioned above can be composed of a clamping circuit composed of diodes, a gas discharge tube, or a TVS tube.

For the body surface ECG signal, through the body surface ECG signal input interface 7, after the integrated instrumentation amplifier (such as the AD8422 produced by ADI Company) performs impedance transformation, it is sent to the amplifier one with integrated operation function (such as the AD822 produced by ADI Company) enlarge. The amplified body surface ECG signal is sent to a high-speed ADC (such as AD7634 produced by ADI) through a multi-way switch (such as ADG1206 or ADG1208 produced by ADI), and converted into a digital signal. The maximum sampling rate is not less than 250kSPS, and the conversion effective number of bits is not less than 14.

For the intracardiac electrical signal collected by the catheter in the patient's body, after the impedance conversion is carried out through the integrated instrumentation amplifier (such as the AD8429 produced by ADI Company) through the intracardiac electrical signal input interface 6, it is sent to the amplifier 2 with integrated operation function (such as the product produced by ADI Company). LT1468, LT1469) are amplified. Note that the amplified intracardiac electrical signal is still a single-ended signal and is susceptible to interference on the transmission link. Therefore, preferably, in order to enhance the anti-interference ability of the intracardiac electrical signal in the transmission link, a single-ended to differential signal can be used. An amplifier (such as ADA4922 produced by ADI) converts it into a differential signal, and then passes through a multi-channel switch and sends it to one of the high-speed ADCs.

For the invasive blood pressure in the patient's body, it is measured by the pressure sensor in the catheter through the invasive blood pressure signal input interface 10, which is essentially a Wheatstone bridge composed of four resistors, and the resistance value of one of the resistors varies with the invasive blood pressure. fluctuations will change. Therefore, when in use, a known excitation signal must be applied to one diagonal of the bridge from the outside to obtain the output voltage difference on the other diagonal. In the blood pressure environment of the human body, the typical value of the voltage difference is 1-3mV. The low-speed ADC is a 24-bit low-speed ADC with a bandwidth of 4.8KHz built in AD7195 produced by ADI. After the AC excitation signal is applied to the bridge by AD7195, its built-in ADC directly converts the voltage difference output by the bridge into a digital signal.

Under the control of the program, the stimulation delivery module sends the intracardiac stimulation signal to the patient through the catheter through the intracardiac signal input interface. The current and voltage of the stimulation signal are collected by the I/V sampler and sent to the high-speed ADC2 for real-time monitoring.

The non-invasive blood pressure cuff connected to the non-invasive blood pressure measurement interface 9 measures the patient's non-invasive blood pressure under program control; the blood oxygen sensor connected to the blood oxygen saturation signal input interface 8 measures the patient's blood oxygen saturation under program control; Finally, the channel expansion interface 1 on the housing 17 is used to expand the channel of the above-mentioned patient signal.

The above body surface electrocardiographic signals, intracardiac electrical signals, invasive blood pressure signals, and voltage and current signals of stimulation signals are converted into corresponding digital signals, passed through the electrical isolation interface 1, and processed in the programmable logic array and digital signal processor. be processed in. Electrical isolation interface 1 is used to isolate the live part of the patient and the patient coupling unit. The signal isolation part is realized by digital isolation devices, such as ADuM261, ADuM263, ADuM2251 produced by ADI Company; the power isolation part is realized by the existing electrical function Realized switching power supply module.

The main devices after the electrical isolation interface 1 are programmable logic arrays (such as Spartan-6 series produced by Xilinx Company) and digital signal processors (such as TMS320C6748 produced by TI Company). The digital processing module composed of the two is connected with a serial port hub (such as TL16CP754 produced by TI Company). The serial port hub is connected to the non-invasive blood pressure measurement module (ie, NIBP module) and the blood oxygen saturation module (ie, SpO ₂ module). The aforementioned non-invasive blood pressure signal is sent to the digital processing module for processing through the NIBP module and the serial port hub; the aforementioned blood oxygen saturation signal is also sent to the digital processing module for processing through the _SpO2 module and also via the serial port hub. At the same time, the serial port hub is connected to the serial port interface on the shell 17 for external diagnosis and debugging. In addition to being connected to the above-mentioned equipment, the digital processing module is also connected to an Ethernet communication module (such as LAN8710Ai), which is used to communicate with the computing unit based on the embedded SoM through the RJ-45 interface; inside the shell 17, the digital processing module is also connected to the I These I/O devices include some buttons, knobs, indicator lights, buzzers and other human-computer interaction devices; at the same time, the digital signal of the digital processing module passes through the electrical isolation interface 2 to drive a high-speed DAC (such as ADI Corporation). Produced AD5623), the analog signal is output from the analog output port, and the analog signal can be synchronized and transmitted between devices with external analog signal input.

The patient coupling unit with signal conditioning function is powered by the RJ-45 interface with PoE function, the power bus as shown by the thick arrow in Figure 15, through its internal PoE power supply, and DC-DC converter with electrical isolation , to supply power for the digital signal processing part and the analog front-end circuit respectively. The electrical isolation interface 2 shown in the figure is used to isolate the external PoE power supply and the internal digital signal processing device. The signal isolation part is realized by using the existing Ethernet transformer; the power supply isolation part is realized by the existing switching power supply module with electrical functions.

As shown in Fig. 3 to Fig. 7, the design view of the patient coupling unit with signal conditioning function, its size is 224.5×160×80mm. Among them, a single patient coupling unit has a 50-channel intracardiac signal input interface 6, which can be used to receive the patient's intracardiac signal and recognize all input signals as unipolar signals. In the software of the computing unit, any channel can be arbitrarily Single and bipolar configurations. At the same time, it has a body surface ECG signal input interface 7, a blood oxygen saturation input interface 8, a non-invasive blood pressure measurement interface 9, and an invasive blood pressure input interface 10, which can measure the above physiological signals.

There are 50 intracardiac signal input interfaces 6 on the main panel 11, which can be used to receive the patient's intracardiac signal. Clamping protection circuit 12 performs clamping protection on 50 intracardiac signal input interfaces 6 respectively, so as to prevent large-scale interference signals (such as body surface defibrillation signals and radio frequency ablation signals) that may appear on the interface from causing damage to subsequent circuits. damage. In addition, the non-invasive blood pressure circuit and blood oxygen saturation circuit 18 collects and processes non-invasive blood pressure signals and blood oxygen saturation signals from the patient's body. The signal conditioning circuit 13 conditions the above various signals from the patient, and finally transmits them to the power supply and communication circuit 15 in the form of digital signals. The power supply and communication circuit 15 further processes the digital signal and sends it to the computing unit based on the embedded SoM through the power supply communication interface 4 . In addition, the power supply and communication circuit 15 also converts the power supply communication interface 4 from the Ethernet interface 25 with PoE function to a voltage usable by other circuits through a DC-DC converter, so as to provide power for the entire patient coupling unit. The above-mentioned circuits are all integrated in the patient coupling unit housing 17 through the circuit board guide rail 16 , and obtain signals and power through the connectors on the left side panel 14 and the right side panel 19 . There may be cooling holes on the left side panel 14 and the right side panel 19 to play the role of cooling the patient coupling unit.

As shown in FIG. 15 , a schematic diagram of the functional modules of the computing unit based on the embedded SoM. The computing unit is based on a high-performance SoM (such as Jetson TX2 produced by NVIDIA), and has a power manager, various digital interfaces, and peripherals such as Ethernet interfaces with PoE functions and HDBT interfaces with PoE functions. As shown by the thick arrow in Figure 15, the computing unit is powered by a medical AC-DC converter, which obtains power from the mains interface, converts it into a DC power supply for the computing unit itself, and drives the PoE driver at the same time. The network interface supplies power to the patient coupling unit with signal conditioning.

The working process of the computing unit is described in detail below. After the calculation unit is connected to the RJ-45 interface of the patient coupling unit with signal conditioning function through the Ethernet interface shown in Figure 15 through the network cable, the calculation unit sends a data transmission request to the patient coupling unit, and performs data exchange through Ethernet. The patient's surface ECG signal, intracardiac electrical signal, invasive blood pressure signal, blood oxygen saturation signal and non-invasive blood pressure signal that have been collected and converted into digital signals are obtained from the patient coupling unit. The computing unit processes these signals separately according to the sending time and device information marked by the patient coupling unit. For signals from the same coupling unit, classify according to the type of the signal, and then sort the received data according to the marked sending time. The sorted data reflects the patient's physiological signals over a period of time. In the next step, the computing unit uses the internal data encoding logic to re-encode the sorted data, which can be output through different transmission paths depending on the encoding. In this embodiment, if the data is encoded into a USB data format, it can be sent to an external USB device through the USB interface; if the data is encoded into a format supported by HDBT and sent to the HDBT driver, then the video signal and the data signal can be transmitted through the HDBT interface. After packaging, the corresponding video data will be output in the form of network data through the network cable; if the data is encoded in HDMI video format, it can be output to an external display device through the HDMI interface for real-time analysis and diagnosis by doctors; if the data is encoded in hard disk file format, it can be Save to the local hard disk through the SATA interface.

9 to 14 are design views of an embedded SoM-based computing unit in an embodiment of the present invention, and its size is 330×330×45mm. The computing unit housing consists of an upper cover 27, a bottom plate 30 and side panels, all of which are made of aluminum alloy. The side panel has a cooling fan 26, which has good heat dissipation performance and good electromagnetic interference shielding performance. The power switch and interface 22 is used to connect the power supply and control the switch of the power module 28 . 24HDBT interface is used to connect display or central station to transmit digital video and data signals; Ethernet interface 25 with PoE function is connected to patient coupling unit with signal conditioning function to supply power and transmit data; 20HDMI interface is connected to display to output digital Video signal; 21USB interface can be used for programming and debugging of high-performance SoM, and can also connect external USB devices.

The calculation unit main board 29 is fixed on the base plate 30 and has a power supply module 28 which functions as an AC-DC conversion and provides power for the calculation unit main board 29 .

As shown in FIG. 16 , it is a structural diagram of the distributed data transmission and the realization of real-time multi-party consultation in the present invention. Among them, several embedded SoM-based computing units and central stations are deployed in the hospital's internal network. The above-mentioned central stations can be realized by switches or servers, and can be arranged in hospitals such as nurse stations and monitoring stations. The computing units based on the embedded SoM are respectively connected to the central station through their own HDBT interfaces, and transmit the data processed respectively, so that the medical staff in the hospital can monitor the physiological parameters of the patients in the hospital at the central station. At the same time, after the central station performs certain operations on the transmitted data, such as adding some data source marks, data encryption, etc., the data is transmitted to the hospital's external network through the transmission link. The above-mentioned transmission link may be based on a wireless network, or may be based on a wired network, or a transmission link based on an optical fiber. Physicians located remotely establish a connection with the central station through their respective PCs via a transmission link, and the received data is analyzed by the dedicated software in the PC and displayed on the monitor, so that multiple physicians can simultaneously monitor the patient's Electrophysiological waveforms can be used to diagnose and realize multi-party consultation on patients.

The invention combines the patient interface unit and the electrophysiological signal amplification unit in the existing electrophysiological system to form a patient coupling unit with signal conditioning function, and reduces the number of interconnected devices in the system without reducing the performance of the existing electrophysiological system The number of the number; PoE technology is used to combine communication cables and power supply cables to simplify the connection between devices; the system uses low-voltage DC power supply internally to reduce the risk of electric shock to patients under a single fault state; the computing unit adopts an embedded system based on As the core, the SoM can not only be made very compact, but also has abundant peripheral equipment resources. It can drive multiple display devices without other auxiliary devices such as adapters; it is convenient for equipment sharing, equipment transfer and remote deployment.

In the system of the present invention, the patient coupling unit and the embedded SoM computing unit, the integrated circuits, modules, interfaces, etc. used inside can be replaced and adjusted by professional technicians in the field according to the needs of specific actual conditions. Types and models are not limited to the above-mentioned disclosed types and models, and the above-mentioned disclosed types and models are only provided by the invention that can realize a complete technical solution.

The main advantages of the present invention include: greatly reducing the overall volume and weight of the traditional electrophysiological system; simplifying the connection in cardiac interventional surgery; stable work and low failure rate; reducing the cost of transportation and storage; safer for patients; efficiency.

Claims (10)

1. An integrated electrophysiological signal recording and processing system, including a patient coupling unit and an embedded SoM computing unit, characterized in that: the input end of the patient coupling unit is connected to several external signals, and the patient coupling unit is bidirectionally connected to the embedded SoM computing unit , the output end of the embedded SoM computing unit is connected to the display; the patient coupling unit includes a shell, a main panel, a clamp protection circuit, a signal conditioning circuit, a left panel, a power supply and communication circuit, a right panel, and a noninvasive blood pressure detection circuit And blood oxygen saturation detection circuit, the shell (17) is a rectangular parallelepiped cylindrical structure, located inside the shell (17) is provided with a clamp protection circuit (12), a signal conditioning circuit (13), a power supply and communication circuit (15 ), and the clamping protection circuit (12), signal conditioning circuit (13), power supply and communication circuit (15) are spaced apart from each other and arranged through the circuit board guide rails (16) on the left and right sides of the housing (17), and are located in the housing (17) ) is embedded with a main panel (11), and the front and rear ends of the housing (17) are respectively connected to the left side panel (14) and the right side panel (19); one side of the signal conditioning circuit (13) is provided with a noninvasive blood pressure Detection circuit and blood oxygen saturation detection circuit (18);

   The embedded SoM computing unit includes an upper cover plate, a power supply module, a computing unit main board, a base plate, a left side plate, and a right side plate, and the described base plate (30) is in a U-shaped structure, and the top of the base plate (30) is connected to The cover plate (27) is provided with a calculation unit main board (29) inside between the base plate (30) and the upper cover plate (27), and the upper side of the calculation unit main board (29) is provided with a power supply module (28), which is located The front and rear ends of the bottom plate (30) are respectively connected to the left side plate (31) and the right side plate (32).
2. An integrated electrophysiological signal recording and processing system according to claim 1, characterized in that: the main panel (11) of the patient coupling unit is provided with an intracardiac signal input interface (6); 17) is provided with operation buttons (5) on one side; on the left panel (14) are respectively provided with body surface ECG signal input interface (7), blood oxygen saturation signal input interface (8), non-invasive blood pressure measurement interface ( 9), invasive blood pressure signal input interface (10); located on the right panel (19), there are channel expansion interface (1), analog output interface (2), RS-232 communication interface (3), power supply communication interface (4).
3. A kind of integrated electrophysiological signal recording and processing system according to claim 1, is characterized in that: the left side board (31) of described embedded SoM computing unit is respectively provided with HDBT interface (24), has The Ethernet interface (25) of the PoE function is located at the HDBT interface (24), and the left side plate (31) of the Ethernet interface (25) with the PoE function is embedded with a cooling fan (26); HDMI interface (20) and USB interface (21) are respectively arranged on the side panel (32), and power interface and switch are embedded on the right side panel (32) on the side of HDMI interface (20) and USB interface (21). (twenty two).
4. An integrated electrophysiological signal recording and processing system according to claim 1 or 2, characterized in that: the clamp protection circuit (12), signal conditioning circuit (13), power supply And the communication circuit (15) and the noninvasive blood pressure detection circuit and the blood oxygen saturation detection circuit (18) are provided with several functional modules, and the several functional modules include amplifiers, multi-way switches, high-speed ADCs, low-speed ADCs, I/V Sampler, stimulus distributor, programmable logic array and digital signal processor, Ethernet communication module, I/O device, serial port hub, NIBP module, _SpO2 module, intracardiac signal input interface (6), body surface ECG signal The input interface (7) is respectively connected to one end of the amplifier one and the amplifier two through the clamp protection circuit, the other end of the amplifier one and the amplifier two is connected to one end of the multi-way switch, and the other end of the multi-way switch is connected to one end of the high-speed ADC one; The blood pressure signal input interface (10) is connected to one end of the low-speed ADC; the other end of the high-speed ADC one and the low-speed ADC is connected to the programmable logic array and the digital signal processor through an electrical isolation interface one; the blood oxygen saturation signal input interface (8) is connected through an electrical One end of the isolation interface one connects the NIBP module, the noninvasive blood pressure measurement interface (9) connects one end of the _SpO2 module through the electrical isolation interface one, and the other end of the NIBP module and the _SpO2 module connects the serial port hub; the described connection programmable logic array and The digital signal processor is bidirectionally connected with the serial port hub, the Ethernet communication module and the I/O device respectively; the Ethernet communication module is connected with the power supply communication interface (4) through the second connection of the electrical isolation interface; it is connected with the programmable logic array and the digital signal processor The output end of the device is divided into two routes, one is connected to one end of the high-speed DAC through the electrical isolation interface 2, and the other end of the high-speed DAC is connected to the analog output interface (2); The other end is divided into two roads, one road is connected with the inner signal input interface (6) and the amplifier two; the other road is connected with one end of the I/V sampler, and the other end of the I/V sampler is connected with one end of the high-speed ADC two, and the high-speed ADC two The other end of the cable is connected to the serial port hub through the electrical isolation interface one.
5. An integrated electrophysiological signal recording and processing system according to claim 4, characterized in that: said power supply communication interface (4) is connected to a power bus through a PoE power supply.
6. An integrated electrophysiological signal recording and processing system according to claim 4, characterized in that: said RS-232 communication interface (3) is connected to a serial port hub.
7. An integrated electrophysiological signal recording and processing system according to claim 4, characterized in that: the NIBP module is a serial port hub connected to a noninvasive blood pressure measurement module.
8. An integrated electrophysiological signal recording and processing system according to claim 4, wherein the SpO ₂ module is a blood oxygen saturation module.
9. A kind of integrated electrophysiological signal recording and processing system according to claim 1, is characterized in that: SoM module, HDBT driver, SATA interface, medical AC-DC converter, low-voltage power converter, PoE driver, the SoM module is provided with an encoding logic module, the power supply module (28) is provided with a power manager, and the 220V AC power passes through the medical AC-DC converter and Coding logic module, low-voltage power converter and PoE driver power supply connection; Ethernet interface (25) with PoE function is connected to PoE driver bidirectionally; PoE driver is connected to SoM module bidirectionally; SoM module and power management in the power supply module (28) The coding logic module in the SoM module is connected with the SATA interface, the HDMI interface (20), the USB interface (21) respectively, and the SATA interface is connected with the hard disk bidirectionally; the coding logic module in the SoM module passes the HDBT driver and the HDBT interface ( 24) Connect.
10. An integrated electrophysiological signal recording and processing system according to any one of claims 1 to 11, characterized in that: the electrophysiological signal recording and processing system uses HDBT inside the embedded SoM computing unit The interface (24) is connected with the central station, and the central station is connected with the PC end of the external network through a transmission link.

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