An integrated electrophysiological signal recording and processing system

Abstract

The present invention relates to the technical field of medical devices, and specifically to an integrated electrophysiological signal recording and processing system. An integrated electrophysiological signal recording and processing system includes a patient coupling unit and an embedded SoM computing unit. It is characterized in that: the input end 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 end of the embedded SoM computing unit is connected to a display. Compared with the prior art, an integrated electrophysiological signal recording and processing system is provided, which 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, reducing the number of interconnected devices in the system without degrading the performance of the existing electrophysiological system; using PoE technology, combining communication cables and power supply cables to simplify the connection between devices.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an integrated electrophysiological signal recording and processing system. Background Art

[0002] For diseases such as atrial fibrillation and atrial flutter caused by abnormal cardiac electrical activities in modern medicine, radiofrequency ablation is usually used for treatment. Before treatment, it is necessary to identify the abnormal electrical activities in the patient's heart. Currently, the identification of abnormal electrical activities in the heart is mainly completed by a multi-channel electrophysiological recording system. The operator inserts a special medical catheter through the patient's venous or arterial system, and the tip of the medical catheter finally reaches the patient's atrium or ventricle, and collects the intracardiac electrical activity signals (i.e., cardiac electrophysiological signals) through the electrodes on the tip of the catheter. Then, through the device connected to the catheter, the cardiac electrophysiological signals collected by the electrodes are amplified and conditioned, and then transmitted to a computer, where the software in the computer further processes and displays them as intracardiac electrical activity waveforms with diagnostic significance. The operator analyzes the above electrical activity waveforms, judges the abnormal electrical signal conduction pathway in the heart, and uses a special medical catheter to perform radiofrequency ablation to achieve the purpose of treatment.

[0003] Among the existing publicly disclosed products and technical solutions, a representative one is a multi-channel electrophysiological recording system with mapping function publicly disclosed by St. Jude Company in the United States, as Figure 1 shown. It mainly consists of three devices: 1. An amplifier, which is used to amplify and condition the electrophysiological signals from the patient; 2. A display workstation, which consists of a general computer system and is used to communicate with the amplifier and display the intracardiac electrical activity waveforms; 3. A patient connection module, which is used for the electrical coupling between the patient and the amplifier. These three devices independently obtain electrical energy 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 publicly disclosed by Sichuan Jinjiang Electronic Technology Co., Ltd., which also consists of the above three devices and has a similar system structure.

[0004] It can be found that in the existing products and technical solutions, three devices with different functions need to work together. Compared with a single device, the reliability and stability of the entire system have decreased to a certain extent. Assuming that under general usage and maintenance conditions, the failure rate of a single device is 5%, then the probability that the amplifier, display workstation, and patient connection module all work properly at the same time is only 85.7%, which reduces the overall efficiency of the device user. At the same time, these three devices are connected to each other and to the patient through two types of cables, namely power cables and communication cables. The connection is often relatively complex and more likely to cause failures due to problems such as poor cable contact, which also brings difficulties to the operation of analyzing and troubleshooting faults. Often, the manufacturer needs to send professional personnel to the site for repair. If the repair cannot be completed on-site, the device user also needs to pay high logistics and insurance costs to send the device back to the manufacturer for inspection, which greatly increases the repair and maintenance costs of the device user. In terms of the usage environment of the device, due to the presence of other large devices such as X-ray machines and C-arm machines, the electromagnetic interference and ionizing radiation generated by them will affect the communication between devices and may also shorten the lifespan of the electronic components inside the device, reducing its reliability. Further, since the device is powered by independent AC mains power, in the event of a single fault, such as when the protective grounding wire is broken, there is a risk of patient electric shock, and in the case of non-equipotential grounding, there is a risk of microshock. At the same time, the above three devices are relatively large in size and weight and require a special trolley for support and movement, which is not conducive to the sharing of devices between operating rooms and reduces the utilization rate of high-value devices.

[0005] From the analysis of the typical scenarios of clinical use of existing devices, patients with electrocardiogram abnormalities are usually treated uniformly in the interventional ward or catheterization laboratory of the hospital. Similar to other inpatients in the hospital, patients in the interventional ward also need continuous monitoring of basic vital signs such as electrocardiogram, fingertip oxygen saturation, and non-invasive blood pressure. At the same time, due to the large number of patients, medical staff usually need to monitor them in the form of a nurse station, but this kind of monitoring has problems such as low communication reliability and delayed information feedback, which brings certain inconvenience and even potential safety hazards to the life monitoring of patients.

[0006] Based on the above analysis, there is currently a lack of a highly integrated electrophysiological signal recording system in the electrophysiology field, which can not only reduce the size of the device, simplify the connection between devices, integrate patient monitoring functions, and integrate the structure of distributed monitoring and diagnosis, thereby enhancing the safety, usability, reliability, and interconnectivity of such devices. Summary of the Invention

[0007] 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 patient coupling unit with signal conditioning function, reducing the number of interconnected devices in the system without degrading the performance of the existing electrophysiological system; using PoE technology, combining the communication cable and the power supply cable to simplify the connection between devices.

[0008] To achieve the above object, an integrated electrophysiological signal recording and processing system is designed, 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, the patient coupling unit is bidirectionally connected to the embedded SoM computing unit, and the output end of the embedded SoM computing unit is connected to a display; the patient coupling unit includes a housing, a main panel, a clamping protection circuit, a signal conditioning circuit, a left panel, a power supply and communication circuit, a right panel, a non-invasive blood pressure detection circuit and a blood oxygen saturation detection circuit. The housing is in a cuboid cylindrical structure. Inside the housing, there are a clamping protection circuit, a signal conditioning circuit, and a power supply and communication circuit. The clamping protection circuit, the signal conditioning circuit, and the power supply and communication circuit are spaced apart and arranged through the circuit board guides on the left and right sides inside the housing. The main panel is embedded at 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; on one side of the signal conditioning circuit, there are a non-invasive blood pressure detection circuit and a blood oxygen saturation detection circuit; the embedded SoM computing unit includes an upper cover plate, a power module, a computing unit main board, a bottom plate, a left side plate, and a right side plate. The bottom plate is in a U-shaped structure, and the upper cover plate is connected above the bottom plate. Inside the space between the bottom plate and the upper cover plate, there is a computing unit main board. The power module is arranged on one side above the computing unit main board. The front and rear ends of the bottom plate are respectively connected to the left side plate and the right side plate.

[0009] On the main panel of the patient coupling unit, there is an intracardiac signal input interface; on one side of the housing, there are operation buttons; on the left panel, there are a surface ECG signal input interface, a blood oxygen saturation signal input interface, a non-invasive blood pressure measurement interface, and an invasive blood pressure signal input interface respectively; on the right panel, there are a channel expansion interface, an analog output interface, an RS-232 communication interface, and a power supply and communication interface respectively.

[0010] On the left side plate of the embedded SoM computing unit, there are an HDBT interface and an Ethernet interface with PoE function respectively. On the left side plate on one side of the HDBT interface and the Ethernet interface with PoE function, there is a cooling fan embedded; on the right side plate, there are an HDMI interface and a USB interface respectively. On the right side plate on one side of the HDMI interface and the USB interface, there are a power interface and a switch embedded.

[0011] There are several functional modules provided on the clamping 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. The several functional modules include an amplifier, a multiplexer, a high-speed ADC, a low-speed ADC, an I / V sampler, a stimulator, a programmable logic array and a digital signal processor, an Ethernet communication module, an I / O device, a serial port hub, a NIBP module, a SpO2 module. The intracardiac signal input interface and the body surface ECG signal input interface are respectively connected to one end of amplifier one and amplifier two through the clamping protection circuit. The other ends of amplifier one and amplifier two are connected to one end of the multiplexer. The other end of the multiplexer is connected to one end of high-speed ADC one. The invasive blood pressure signal input interface is connected to one end of the low-speed ADC. The other ends of high-speed ADC one and the low-speed ADC are connected to the programmable logic array and the digital signal processor through electrical isolation interface one. The non-invasive blood pressure measurement input interface is connected to one end of the NIBP module through electrical isolation interface one. The blood oxygen saturation signal input interface is connected to one end of the SpO2 module through electrical isolation interface one. The other ends of the NIBP module and the SpO2 module are connected to the serial port hub. The connection between the programmable logic array and the digital signal processor is respectively bidirectionally connected to the serial port hub, the Ethernet communication module and the I / O device. The Ethernet communication module is connected to the power supply and communication interface through electrical isolation interface two. The output end of the connection between the programmable logic array and the digital signal processor is divided into two paths. One path is connected to one end of the high-speed DAC through electrical isolation interface two. The other end of the high-speed DAC is connected to the analog output interface. The other path is connected to one end of the stimulator through electrical isolation interface one. The other end of the stimulator is divided into two paths. One path is connected to the intracardiac signal input interface and amplifier two. The other path is connected to one end of the I / V sampler. The other end of the I / V sampler is connected to one end of high-speed ADC two. The other end of high-speed ADC two is connected to the serial port hub through electrical isolation interface one.

[0012] The power supply and communication interface is connected to the power bus through a PoE power supply.

[0013] The RS-232 communication interface is connected to the serial port hub.

[0014] The NIBP module is a non-invasive blood pressure measurement module connected to the serial port hub.

[0015] The SpO2 module is a blood oxygen saturation module.

[0016] On the computing unit motherboard inside the described embedded SoM computing unit, there are an SoM module, an HDBT driver, a SATA interface, a medical AC-DC converter, a low-voltage power converter, and a PoE driver. There is an encoding logic module inside the SoM module, and a power manager inside the power module. The 220V AC power supply is connected to the encoding logic module, the low-voltage power converter, and the PoE driver through the medical AC-DC converter; The Ethernet interface with PoE function is bidirectionally connected to the PoE driver; The PoE driver is bidirectionally connected to the SoM module; The SoM module is bidirectionally connected to the power manager inside the power module; The encoding logic module inside the SoM module is respectively connected to the SATA interface, the HDMI interface, and the USB interface. The SATA interface is bidirectionally connected to the hard disk; The encoding logic module inside the SoM module is connected to the HDBT interface through the HDBT driver.

[0017] The described 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 terminal on the external network through the transmission link.

[0018] 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 coupling unit with signal conditioning function, reducing the number of interconnected devices in the system without reducing the performance of the existing electrophysiological system; Utilizing PoE technology, combining communication cables and power supply cables simplifies the connection between devices.

[0019] The system is powered by a low-voltage DC power supply internally, reducing the risk of patient electric shock 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 rich peripheral device resources, and can drive multiple display devices without other auxiliary devices such as additional adapters; Facilitating device sharing, device transportation, and remote deployment. Description of the Drawings

[0020] Figure 1 It is a schematic diagram of the functional modules of an existing medical electrophysiological signal recording device.

[0021] Figure 2 It is a schematic diagram of the functional modules of the electrophysiological signal recording device of the present invention.

[0022] Figure 3 It is an exploded view of the structure of the patient coupling unit in the present invention.

[0023] Figure 4 It is a front view of the structure of the patient coupling unit in the present invention.

[0024] Figure 5This is the top view of the patient coupling unit in the present invention.

[0025] Figure 6 This is the left view of the patient coupling unit in the present invention.

[0026] Figure 7 This is the right view of the patient coupling unit in the present invention.

[0027] Figure 8 This is the schematic diagram of the functional modules of the patient coupling unit in the present invention.

[0028] Figure 9 This is the exploded view of the structure of the embedded SoM computing unit in the present invention.

[0029] Figure 10 This is the front view of the structure of the embedded SoM computing unit in the present invention.

[0030] Figure 11 This is the top view of the structure of the embedded SoM computing unit in the present invention.

[0031] Figure 12 This is the rear view of the structure of the embedded SoM computing unit in the present invention.

[0032] Figure 13 This is the left view of the structure of the embedded SoM computing unit in the present invention.

[0033] Figure 14 This is the right view of the structure of the embedded SoM computing unit in the present invention.

[0034] Figure 15 This is the schematic diagram of the functional modules of the embedded SoM computing unit in the present invention.

[0035] Figure 16 This is the structural diagram for distributed data transmission and real-time multi-party consultation.

[0036] See Figures 3 to 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 intracardiac 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 input interface, 10 is the invasive blood pressure signal input interface, 11 is the main panel, 12 is the clamping protection circuit, 13 is the signal conditioning circuit, 14 is the left panel, 15 is the power supply and communication circuit, 16 is the circuit board guide rail, 17 is the housing, 18 is the non-invasive blood pressure detection circuit and blood oxygen saturation detection circuit, 19 is the right panel.

[0037] See Figures 9 to 12, 20 is an HDMI interface, 21 is a USB interface, 22 is a power interface and switch, 24 is an HDBT interface, 25 is an Ethernet interface with PoE function, 26 is a cooling fan, 27 is an upper cover plate, 28 is a power module, 29 is a computing unit main board, 30 is a bottom plate, 31 is a left side plate, and 32 is a right side plate. Detailed implementation

[0038] The present invention will be further described below with reference to the accompanying drawings.

[0039] As Figure 2 shown, the input end 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 end of the embedded SoM computing unit is connected to the display.

[0040] As Figures 3 to 7 shown, the patient coupling unit includes a housing, a main panel, a clamping protection circuit, a signal conditioning circuit, a left side panel, a power supply and communication circuit, a right side panel, a non-invasive blood pressure detection circuit, and a blood oxygen saturation detection circuit. The housing 17 has a rectangular parallelepiped tubular structure. Inside the housing 17, there are a clamping protection circuit 12, a signal conditioning circuit 13, and a power supply and communication circuit 15. The clamping protection circuit 12, the signal conditioning circuit 13, and the power supply and communication circuit 15 are spaced apart from each other and arranged through the circuit board guides 16 on the left and right sides inside the housing 17. The main panel 11 is embedded at the top of the housing 17. 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 non-invasive blood pressure detection circuit and a blood oxygen saturation detection circuit 18 are provided on one side of the signal conditioning circuit 13. The main panel 11 of the patient coupling unit is provided with an intracardiac signal input interface 6. An operation button 5 is provided on one side of the housing 17. A body surface ECG signal input interface 7, a blood oxygen saturation signal input interface 8, a non-invasive blood pressure measurement interface 9, and an invasive blood pressure signal input interface 10 are respectively provided on the left side panel 14. A channel expansion interface 1, an analog output interface 2, an RS-232 communication interface 3, and a power supply communication interface 4 are respectively provided on the right side panel 19.

[0041] As Figure 8As shown, several functional modules are provided on the clamping protection circuit 12, signal conditioning circuit 13, power supply and communication circuit 15, non-invasive blood pressure detection circuit and blood oxygen saturation detection circuit 18 inside the patient coupling unit. The several functional modules include an amplifier, a multiplexer, a high-speed ADC, a low-speed ADC, an I / V sampler, a stimulation generator, a programmable logic array and a digital signal processor, an Ethernet communication module, an I / O device, a serial port hub, a NIBP module, a SpO2 module. The intracardiac signal input interface 6 and the body surface ECG signal input interface 7 are respectively connected to one end of amplifier one and amplifier two through the clamping protection circuit. The other ends of amplifier one and amplifier two are connected to one end of the multiplexer. The other end of the multiplexer is connected to one end of high-speed ADC one. The invasive blood pressure signal input interface 10 is connected to one end of the low-speed ADC. The other ends of high-speed ADC one and low-speed ADC are connected to the programmable logic array and the digital signal processor through electrical isolation interface one. The non-invasive blood pressure measurement input interface 9 is connected to one end of the NIBP module through electrical isolation interface one. The blood oxygen saturation signal input interface 8 is connected to one end of the SpO2 module through electrical isolation interface one. The other ends of the NIBP module and the SpO2 module are connected to the serial port hub. The connection between the programmable logic array and the digital signal processor is respectively bidirectionally connected to the serial port hub, the Ethernet communication module and the I / O device. The Ethernet communication module is connected to the power supply and communication interface 4 through electrical isolation interface two. The output end of the connection between the programmable logic array and the digital signal processor is divided into two paths. One path is connected to one end of the high-speed DAC through electrical isolation interface two. The other end of the high-speed DAC is connected to the analog output interface 2. The other path is connected to one end of the stimulation generator through electrical isolation interface one. The other end of the stimulation generator is divided into two paths. One path is connected to the intracardiac signal input interface 6 and amplifier two. The other path is connected to one end of the I / V sampler. The other end of the I / V sampler is connected to one end of high-speed ADC two. The other end of high-speed ADC two is connected to the serial port hub through electrical isolation interface one.

[0042] The power supply and communication interface 4 is connected to the power bus through a PoE power supply.

[0043] The RS-232 communication interface 3 is connected to the serial port hub.

[0044] The model of Amplifier 1 can be AD822; the model of Amplifier 2 can be LT1468 or LT1469; the model of the multiplexer can be ADG1206 or ADG1208; the model of High-Speed ADC 1 can be AD7634; the model of the Low-Speed ADC can be AD7195; the model of the programmable logic array in the programmable logic array and digital signal processor can be the Spartan-6 series, and 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 model of the serial port hub can be TL16CP754; the model of the Ethernet communication module can be LAN8710Ai; the model of the stimulator can be AD7391. The model of High-Speed ADC 1 can be AD5623.

[0045] The NIBP module is a serial port hub connecting to the non-invasive blood pressure measurement module, and its model can be Advantage+.

[0046] The SpO2 module is a blood oxygen saturation module, and its model can be MSX2040.

[0047] As Figures 9 to 14 shown, the embedded SoM computing unit includes an upper cover plate, a power module, a computing unit main board, a bottom plate, a left side plate, and a right side plate. The bottom plate 30 is in a U-shaped structure. The upper cover plate 27 is connected above the bottom plate 30. The computing unit main board 29 is arranged inside between the bottom plate 30 and the upper cover plate 27. A power module 28 is arranged on one side above the computing unit main board 29. The left side plate 31 and the right side plate 32 are respectively connected to the front and rear ends of the bottom plate 30.

[0048] On the left side plate 31 of the embedded SoM computing unit, there are respectively an HDBT interface 24 and an Ethernet interface 25 with PoE function. A cooling fan 26 is embedded on the left side plate 31 on one side of the HDBT interface 24 and the Ethernet interface 25 with PoE function. On the right side plate 32, there are respectively an HDMI interface 20 and a USB interface 21. A power interface and switch 22 are embedded on the right side plate 32 on one side of the HDMI interface 20 and the USB interface 21.

[0049] As Figure 15As shown in the figure, on the computing unit main board 29 inside the embedded SoM computing unit, there are an SoM module, an HDBT driver, a SATA interface, a medical AC-DC converter, a low-voltage power converter, and a PoE driver. Inside the SoM module, there is an encoding logic module, and inside the power module 28, there is a power manager. The 220V AC power supply is connected to the encoding logic module, the low-voltage power converter, and the PoE driver through the medical AC-DC converter for power supply; the Ethernet interface 25 with PoE function is bidirectionally connected to the PoE driver; the PoE driver is bidirectionally connected to the SoM module; the SoM module is bidirectionally connected to the power manager inside the power module 28; the encoding logic module inside the SoM module is respectively connected to the SATA interface, the HDMI interface 20, and the USB interface 21, and the SATA interface is bidirectionally connected to the hard disk; the encoding logic module inside the SoM module is connected to the HDBT interface 24 through the HDBT driver.

[0050] The model of the SoM module can be Jetson TX2; the models of the HDBT driver can be LT86104 and KSZ9897, the model of the medical AC-DC converter can be the NGB250 series, the models of the low-voltage power converter can be TPS62140 and JHM1012, and the model of the PoE driver can be Ag5300.

[0051] As Figure 16 shown in the figure, 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 side of the external network through a transmission link.

[0052] The system of the present invention includes two units that work together. Among them, the patient coupling unit with signal conditioning function realizes electrical coupling with the patient through surface lead wires, in-vivo catheter electrodes or other media, collects various analog electrical signals with physiological and diagnostic significance from the patient's body, converts the collected analog electrical signals into digital signals through an optimized signal conditioning circuit, and transmits them to the computing unit based on the embedded SoM (System-on-Module) through a PoE (Power over Ethernet, active Ethernet) interface that complies with the IEEE 802.3at standard. The computing unit based on the embedded SoM obtains electrical energy from its power supply subsystem, provides electrical energy for the PoE driver, and provides electrical energy for the patient coupling unit with signal conditioning function through the network cable. After further processing the received digital signals, the computing unit based on the embedded SoM is transmitted through one or more digital video ports and displayed on one or more general or special display devices for the operator to analyze and diagnose.

[0053] This highly integrated multi-functional medical electrophysiological signal recording device is characterized by its small size, stable operation, and low failure rate. It can reduce the space occupied in the operating room and improve the overall efficiency of cardiac interventional surgery. 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 plural computing units based on the embedded SoM can establish a data connection with the central station also located in the hospital through the wired network or wireless network within the hospital, and the central station is connected to the network outside the hospital through the wired or wireless network port. Medical staff located remotely can diagnose patients in the hospital in real time and conduct multi-party consultations by viewing the data sent out by the central station in the hospital, such as Figure 16 shown.

[0054] Compared with the existing medical electrophysiological recording system, this embodiment only includes two devices, namely a patient coupling unit with signal conditioning function and a computing unit based on the embedded SoM. Only one network cable is used to connect the two devices, greatly simplifying the existing connection method; in terms of power supply, after the computing unit based on the embedded SoM converts the power supply into a DC low-voltage power supply, it is provided to the patient coupling unit with signal conditioning function, which is safer than the independent power supply mode adopted by the existing medical electrophysiological recording system; in terms of appearance, the size and weight of the existing medical electrophysiological recording system are greatly reduced, and the weight of the whole device is less than 6 kg, which is convenient for transportation, storage and use.

[0055] Figure 8 shown is a schematic diagram of the hardware function module of the patient coupling unit with signal conditioning function of the present invention. The electrocardiogram signal collected from the patient's body surface and the intracardiac electrical signal collected from the intracorporeal catheter are respectively coupled to the amplifier through the dedicated interface on the coupling unit housing for amplification. The protection circuit ensures that the amplifier operates in the linear region and protects it from possible damaging energy and damage, such as the defibrillation energy that may appear on the patient's body surface. The above-mentioned protection circuit can be composed of a clamping circuit composed of diodes, or can be composed of a gas discharge tube, or a TVS tube.

[0056] For the electrocardiogram signal on the body surface, through the body surface ECG signal input interface 7, after impedance transformation by an integrated instrumentation amplifier (such as AD8422 produced by ADI Corporation), it is sent to amplifier one with integrated operation function (such as AD822 produced by ADI Corporation) for amplification. The amplified electrocardiogram signal on the body surface passes through a multiplexer (such as ADG1206 or ADG1208 produced by ADI Corporation) and is sent into high-speed ADC one (such as AD7634 produced by ADI Corporation) to be converted into a digital signal. The highest sampling rate of the above-mentioned high-speed ADC one is not less than 250 kSPS, and the effective number of conversion bits is not less than 14 bits.

[0057] For the intracardiac electrical signals collected by the catheter in the patient, after impedance transformation through the intracardiac electrical signal input interface 6 by an integrated instrumentation amplifier (such as AD8429 produced by Analog Devices, Inc.), they are sent to the second amplifier with integrated operational functions (such as LT1468 and LT1469 produced by Analog Devices, Inc.) for amplification. It should be noted that the amplified intracardiac electrical signals are still single-ended signals and are vulnerable to interference in the transmission link. Therefore, preferably, to enhance the anti-interference ability of the intracardiac electrical signals in the transmission link, a single-ended to differential amplifier (such as ADA4922 produced by Analog Devices, Inc.) can be used to convert them into differential signals, and then through a multiplexer, they are sent to the high-speed ADC1.

[0058] For the invasive blood pressure in the patient, it is measured by the pressure sensor in the catheter through the invasive blood pressure signal input interface 10. In essence, it is a Wheatstone bridge composed of four resistors, and the resistance value of one resistor changes with the fluctuation of the invasive blood pressure. Therefore, when in use, a known excitation signal must be applied to one diagonal of the bridge from the outside, and the voltage difference output on the other diagonal is obtained. In the human body blood pressure environment, the typical value of this voltage difference is 1 - 3 mV. The low-speed ADC is a 24-bit low-speed ADC with a bandwidth of 4.8 KHz built in AD7195 produced by Analog Devices, Inc. After AD7195 applies an AC excitation signal to the bridge, its built-in ADC directly converts the voltage difference output by the bridge into a digital signal.

[0059] Under program control, the stimulation delivery module delivers intracardiac stimulation signals to the patient through the intracardiac signal input interface via the catheter. The current and voltage of the stimulation signal are collected by the I / V sampler and sent to the high-speed ADC2 to perform the function of real-time monitoring.

[0060] The non-invasive blood pressure cuff connected to the non-invasive blood pressure measurement interface 9 measures the non-invasive blood pressure of the patient under program control; the blood oxygen sensor connected to the blood oxygen saturation signal input interface 8 measures the blood oxygen saturation of the patient under program control; finally, the channel expansion interface 1 on the housing 17 is used to expand the channels of the above patient signals.

[0061] After the above surface electrocardiogram signals, intracardiac electrical signals, invasive blood pressure signals, and voltage and current signals of the stimulation signals are converted into corresponding digital signals, they are processed in the programmable logic array and digital signal processor after passing through the electrical isolation interface 1. The electrical isolation interface 1 is used to isolate the patient and the live parts in the patient coupling unit. Among them, the signal isolation part is implemented by digital isolation devices, such as ADuM261, ADuM263, ADuM2251, etc. produced by Analog Devices, Inc.; the power isolation part is implemented by an existing switching power supply module with electrical functions.

[0062] The main devices after the electrical isolation interface 1 are a programmable logic array (such as the Spartan-6 series produced by Xilinx) and a digital signal processor (such as the TMS320C6748 produced by TI). The digital processing module composed of the two is connected to a serial port hub (such as the TL16CP754 produced by TI). The serial port hub is connected to a non-invasive blood pressure measurement module (i.e., the NIBP module) and a blood oxygen saturation module (i.e., the SpO2 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 sent to the digital processing module for processing through the SpO2 module and also through the serial port hub. At the same time, the serial port hub is connected to the serial port interface on the housing 17 for external diagnosis and debugging. In addition to being connected to the above-mentioned devices, the digital processing module is also connected to an Ethernet communication module (such as the LAN8710Ai) for communicating with a computing unit based on an embedded SoM through an RJ-45 interface; inside the housing 17, the digital processing module is also connected to I / O devices, including some human-computer interaction devices such as buttons, knobs, indicator lights, and buzzers; 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 the AD5623 produced by ADI), and an analog signal is output from the analog output port, and this analog signal can be synchronized and signal-transmitted with external analog signal input devices.

[0063] The patient coupling unit with signal conditioning function is powered by an RJ-45 interface with PoE function, such as Figure 15 The power bus shown by the thick arrow supplies power to the digital signal processing part and the analog front-end circuit respectively through the PoE power supply inside it and a DC-DC converter with electrical isolation. The electrical isolation interface 2 shown in the figure is used to isolate the external PoE power supply and the internal digital signal processing devices. Among them, the signal isolation part is implemented using an existing Ethernet transformer; the power isolation part is implemented by an existing switching power supply module with electrical function.

[0064] Figures 3 to 7 As shown, the design view of the patient coupling unit with signal conditioning function has a size of 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 intracardiac signals of patients and identify all input signals as unipolar signals. In the software of the computing unit, any channel can be arbitrarily configured as single or bipolar. At the same time, it has a 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, and can measure the above physiological signals.

[0065] The main panel 11 is provided with 50 intracardiac signal input interfaces 6, which can be used to receive the intracardiac signals of patients. The clamping protection circuit 12 performs clamping protection on the 50 intracardiac signal input interfaces 6 respectively to prevent large-amplitude interference signals (such as body surface defibrillation signals and radiofrequency ablation signals) that may appear on the interfaces from damaging the subsequent circuits. In addition, the non-invasive blood pressure circuit and the blood oxygen saturation circuit 18 collect and process the non-invasive blood pressure signals and blood oxygen saturation signals from the patient's body. The signal conditioning circuit 13 conditions the various signals from the patient above, 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 signals and sends them 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 obtains power from the Ethernet interface 25 with PoE function through the power supply communication interface 4, and converts it into a voltage that can be used by other circuits through a DC-DC converter, so as to realize power supply for the entire patient coupling unit. The above circuits are all integrated in the patient coupling unit housing 17 through the circuit board guide rail 16, and signals and power are obtained through the connectors on the left panel 14 and the right panel 19. The left panel 14 and the right panel 19 may be provided with heat dissipation holes to play a role in dissipating heat from the patient coupling unit.

[0066] Figure 15 As shown, it is a schematic diagram of the functional modules of the computing unit based on the embedded SoM. This computing unit takes a high-performance SoM as the core (such as Jetson TX2 produced by NVIDIA Corporation), has a power manager, various digital interfaces, and peripherals such as an Ethernet interface with PoE function and an HDBT interface with PoE function. As Figure 15 shown by the thick arrow in the figure, the power supply of this computing unit uses a medical AC-DC converter to obtain power from the mains interface, convert it into a DC power supply to supply power to the computing unit itself, and at the same time drive the PoE driver to supply power to the patient coupling unit with signal conditioning function through the Ethernet interface with PoE function.

[0067] The working process of this computing unit is described in detail below. The computing unit uses a network cable through Figure 15After the shown Ethernet interface is connected to the RJ-45 interface of the patient coupling unit with signal conditioning function, the computing unit sends a data transfer request to the patient coupling unit, conducts data exchange via Ethernet, and obtains the electrocardiogram signals on the patient's body surface, intracardiac electrical signals, invasive blood pressure signals, blood oxygen saturation signals, and non-invasive blood pressure signals that have been collected and converted into digital signals from the patient coupling unit. The computing unit processes these signals respectively according to the sending time and device information marked by the patient coupling unit. For signals from the same coupling unit, they are classified according to the signal category, and then the received data is sorted according to the marked sending time. The sorted data reflects the physiological signals of the patient over a period of time. Next, the computing unit uses the internal data encoding logic to re-encode the sorted data, and according to the different encodings, it can be output through different transmission paths. In this embodiment, if the data is encoded in the USB data format, it can be sent to an external USB device through the USB interface; if the data is encoded in the format supported by HDBT and sent to the HDBT driver, then through the HDBT interface, the video signal and data signal can be packed and the corresponding video data can be output in the form of network data through the network cable; if the data is encoded in the HDMI video format, it can be output to an external display device for real-time analysis and diagnosis by the physician; if the data is encoded in the hard disk file format, it can be saved to the local hard disk through the SATA interface.

[0068] Figures 9 to 14 As shown, it is the design view of the computing unit based on the embedded SoM in an embodiment of the present invention, with a size of 330×330×45mm. The housing of the computing unit consists of an upper cover plate 27, a bottom plate 30, and side panels, all made of aluminum alloy. The side panels are equipped with a cooling fan 26, having good heat dissipation performance and good electromagnetic interference shielding performance. The power switch and interface 22 are used to connect the power supply and control the switch of the power supply module 28. The 24HDBT interface is used to connect to a monitor or a central station to transmit digital video and data signals; the Ethernet interface 25 with PoE function is connected to the patient coupling unit with signal conditioning function to supply power to it and transmit data; the 20HDMI interface is connected to a monitor to output digital video signals; the 21USB interface can be used for programming and debugging of the high-performance SoM and can also be connected to an external USB device.

[0069] The main board 29 of the computing unit is fixed on the bottom plate 30 and has a power supply module 28, which functions as AC-DC conversion to provide electrical energy for the main board 29 of the computing unit.

[0070] Figure 16As shown in the figure, it is the structural diagram of the distributed data transmission and real-time multi-party consultation implementation of the present invention. Among them, several computing units based on embedded SoM and a central station are deployed in the hospital internal network. The above central station can be implemented through methods such as switches or servers, and can be arranged in places within the hospital such as nurse stations and monitoring stations. The computing units based on embedded SoM are respectively connected to the central station through their own HDBT interfaces and transmit the data they have processed, so that medical staff in the hospital can monitor the physiological parameters of in-hospital patients at the central station. At the same time, after performing certain operations on the transmitted data, such as adding some marks of the data sources and encrypting the data, the central station transmits these data to the hospital external network through the transmission link. The above transmission link can be a wireless network-based transmission, a wired network-based transmission, or an optical fiber-based transmission link. Physicians located remotely establish connections with the central station through their respective PCs via the transmission link, and the dedicated software in the PCs parses the received data and displays it on the monitors, so that multiple physicians can simultaneously diagnose the electrophysiological waveforms of the patients and achieve multi-party consultation for the patients.

[0071] The present 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, reducing the number of interconnected devices in the system without reducing the performance of the existing electrophysiological system; using PoE technology to combine communication cables and power supply cables to simplify the connection between devices; the system internally uses a low-voltage DC power supply to reduce the risk of patient electric shock in a single fault state; the computing unit uses an embedded SoM as the kernel, which can not only be made very small in volume, but also has rich peripheral device resources, and can drive multiple display devices without other redundant adapters and other auxiliary devices; it is convenient for device sharing, device transfer and remote deployment.

[0072] In the system of the present invention, for the integrated circuits, modules, interfaces, etc. used inside the patient coupling unit and the embedded SoM computing unit, those skilled in the art can replace and adjust them according to the specific actual situation requirements, and the types and models used are not limited to the types and models disclosed above, and the types and models disclosed above are only provided for the present invention to be able to implement a complete technical solution.

[0073] 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 intervention surgery; stable in operation and low in failure rate; reducing the costs of transportation and storage; safer for patients; improving the surgical efficiency.

Claims

1. An integrated electrophysiological signal recording and processing system, comprising 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. The patient coupling unit is bidirectionally connected to the embedded SoM computing unit, and the output end of the embedded SoM computing unit is connected to the display. The patient coupling unit includes a housing, a main panel, a clamping protection circuit, a signal conditioning circuit, a left panel, a power supply and communication circuit, a right panel, a non-invasive blood pressure detection circuit and a blood oxygen saturation detection circuit. The housing (17) is in a cuboid cylinder structure. Inside the housing (17), there are a clamping protection circuit (12), a signal conditioning circuit (13), and a power supply and communication circuit (15). The clamping protection circuit (12), the signal conditioning circuit (13), and the power supply and communication circuit (15) are spaced apart from each other and arranged through the circuit board guides (16) on the left and right sides inside the housing (17). The main panel (11) is embedded at the top of the housing (17). The front and rear ends of the housing (17) are respectively connected to the left panel (14) and the right panel (19). The non-invasive blood pressure detection circuit and the blood oxygen saturation detection circuit (18) are provided on one side of the signal conditioning circuit (13). The embedded SoM computing unit includes an upper cover plate, a power module, a computing unit main board, a bottom plate, a left plate, and a right plate. The bottom plate (30) is in a U-shaped structure. The upper cover plate (27) is connected above the bottom plate (30). Inside the space between the bottom plate (30) and the upper cover plate (27), there is a computing unit main board (29). The power module (28) is provided on one side above the computing unit main board (29). The left plate (31) and the right plate (32) are respectively connected to the front and rear ends of the bottom plate (30). On the main panel (11) of the patient coupling unit, there is an intracardiac signal input interface (6). An operation button (5) is provided on one side of the housing (17). On the left panel (14), there are a body surface ECG signal input interface (7), a blood oxygen saturation signal input interface (8), a non-invasive blood pressure measurement interface (9), and an invasive blood pressure signal input interface (10). On the right panel (19), there are a channel expansion interface (1), an analog output interface (2), an RS-232 communication interface (3), and a power supply and communication interface (4). On the left plate (31) of the embedded SoM computing unit, there are an HDBT interface (24) and an Ethernet interface with PoE function (25). A cooling fan (26) is embedded on the left plate (31) on one side of the HDBT interface (24) and the Ethernet interface with PoE function (25). On the right plate (32), there are an HDMI interface (20) and a USB interface (21). A power interface and a switch (22) are embedded on the right plate (32) on one side of the HDMI interface (20) and the USB interface (21). There are several functional modules provided on the clamping protection circuit (12), signal conditioning circuit (13), power supply and communication circuit (15), non-invasive blood pressure detection circuit and blood oxygen saturation detection circuit (18) inside the patient coupling unit. The several functional modules include an amplifier, a multiplexer, a high-speed ADC, a low-speed ADC, an I / V sampler, a stimulation emitter, a programmable logic array and a digital signal processor, an Ethernet communication module, an I / O device, a serial port hub, a NIBP module, an SpO2 module. The intracardiac signal input interface (6) and the body surface ECG signal input interface (7) are respectively connected to one end of amplifier one and amplifier two through the clamping protection circuit. The other ends of amplifier one and amplifier two are connected to one end of the multiplexer. The other end of the multiplexer is connected to one end of high-speed ADC one. The invasive blood pressure signal input interface (10) is connected to one end of the low-speed ADC. The other ends of high-speed ADC one and low-speed ADC are connected to the programmable logic array and the digital signal processor through electrical isolation interface one. The non-invasive blood pressure measurement input interface (9) is connected to one end of the NIBP module through electrical isolation interface one. The blood oxygen saturation signal input interface (8) is connected to one end of the SpO2 module through electrical isolation interface one. The other ends of the NIBP module and the SpO2 module are connected to the serial port hub. The connection between the programmable logic array and the digital signal processor is respectively bidirectionally connected to the serial port hub, the Ethernet communication module and the I / O device. The Ethernet communication module is connected to the power supply communication interface (4) through electrical isolation interface two. The output end of the connection between the programmable logic array and the digital signal processor is divided into two paths. One path is connected to one end of the high-speed DAC through electrical isolation interface two. The other end of the high-speed DAC is connected to the analog output interface (2). The other path is connected to one end of the stimulation emitter through electrical isolation interface one. The other end of the stimulation emitter is divided into two paths. One path is connected to the intracardiac signal input interface (6) and amplifier two. The other path is connected to one end of the I / V sampler. The other end of the I / V sampler is connected to one end of high-speed ADC two. The other end of high-speed ADC two is connected to the serial port hub through electrical isolation interface one. On the computing unit motherboard (29) inside the described embedded SoM computing unit, there are an SoM module, an HDBT driver, a SATA interface, a medical AC-DC converter, a low-voltage power converter, and a PoE driver. An encoding logic module is provided inside the SoM module, and a power manager is provided inside the power module (28). The 220V AC power supply is connected to the encoding logic module, the low-voltage power converter, and the PoE driver through the medical AC-DC converter; an Ethernet interface (25) with PoE function is bidirectionally connected to the PoE driver; the PoE driver is bidirectionally connected to the SoM module; the SoM module is bidirectionally connected to the power manager inside the power module (28); the encoding logic module inside the SoM module is respectively connected to the SATA interface, the HDMI interface (20), and the USB interface (21), and the SATA interface is bidirectionally connected to the hard disk; the encoding logic module inside the SoM module is connected to the HDBT interface (24) through the HDBT driver.

2. An integrated electrophysiological signal recording and processing system according to claim 1, wherein: The described power supply and communication interface (4) is connected to the power bus through a PoE power supply.

3. An integrated electrophysiological signal recording and processing system according to claim 1, characterized in that: The described RS-232 communication interface (3) is connected to a serial port hub.

4. An integrated electrophysiological signal recording and processing system according to claim 1, wherein: The described NIBP module is a non-invasive blood pressure measurement module connected to the serial port hub.

5. An integrated electrophysiological signal recording and processing system according to claim 1, wherein: The described SpO2 module is a blood oxygen saturation module.

6. An integrated electrophysiological signal recording and processing system according to any one of claims 1 to 5, characterized in that: The described 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 end of the external network through a transmission link.

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