CN104660717B

CN104660717B - A kind of method of work of the remote monitoring system of implantable medical devices

Info

Publication number: CN104660717B
Application number: CN201510115286.2A
Authority: CN
Inventors: 陈玥; 陈浩; 马伯志; 郝红伟; 李路明
Original assignee: Beijing Pins Medical Co Ltd
Current assignee: Beijing Pins Medical Co Ltd
Priority date: 2015-03-16
Filing date: 2015-03-16
Publication date: 2018-01-23
Anticipated expiration: 2035-03-16
Also published as: CN104660717A

Abstract

The present invention relates to a kind of method of work of the remote monitoring system of implantable medical devices, it comprises the following steps：Step S12, patient's external controller judge whether to receive instruction in one second time threshold, if it is, into step S13, if it is not, then into step S19；Step S13, patient's external controller decision instruction type, if electricity physiological signal acquisition instructions, then into step S15；Step S15, electricity physiological signal is gathered, the above-mentioned electricity physiological signal collected is sent to the remote monitoring server, and return to step S12；And step S19, indicate communication failure and terminate to communicate.The method of work of the remote monitoring system of implantable medical devices provided by the invention can gather the electricity physiological signal of patient, monitoring means variation, it is possible to achieve the more comprehensively monitoring to patient by the electricity physiological signal sensor.

Description

Working method of remote monitoring system of implantable medical device

Technical Field

The invention relates to the field of implantable medical devices, in particular to a remote monitoring system of an implantable medical device and a working method thereof.

Background

In an implantable medical device, a nerve stimulator effectively controls the symptoms of functional neurological and psychiatric disorders by chronic electrical stimulation of target nerves. FDA approved neurostimulators in the united states and their indications include deep brain stimulators for tremors, parkinson's disease, dystonia, obsessive compulsive disorder, vagus nerve stimulators for epilepsy, depression, spinal cord stimulators for pain, sacral nerve stimulators for urinary incontinence, and the like.

During the treatment of the implantable neurostimulator, patients need to visit the hospital regularly after the operation for follow-up. The medical stimulator has the advantages that on one hand, the monitoring function is achieved, namely, a doctor observes the disease improvement condition of a patient and uses the program controller to obtain stimulator information such as battery capacity, electrode impedance, stimulation parameters and the like, and on the other hand, the program control function is achieved, namely, the doctor adjusts the stimulation parameters according to the change condition of the disease condition and the medication of the patient, so that the patient can move with better curative effect. Patients typically require several or even more hospital visits per year. This burdens the patient with mobility difficulties or remote residence and risks the patient if the implantable neurostimulator fails or the stimulation parameters are inadequate during the interval between visits.

The existing remote monitoring system for implantable medical devices usually employs a huge multimedia electronic device, and doctors are required to observe the condition of patients by operating the angle and the focal length of a camera through a remote controller. The remote monitoring system of the implanted medical apparatus monitors patients only through audio-video communication, has a single means, and has the problems of high operation complexity, poor portability, incomplete monitoring and the like.

Disclosure of Invention

In view of the above, it is necessary to provide a working method of a remote monitoring system for an implantable medical device, which has diversified monitoring means and can monitor more comprehensively.

A method of operating a remote monitoring system for an implantable medical device, the remote monitoring system comprising: the system comprises a doctor terminal, a remote monitoring server, an audio and video communication server, a data analysis server, a patient client, a patient external controller, an implanted medical device and an electrophysiological signal sensor; the patient in-vitro controller comprises a signal acquisition module for controlling the electrophysiological signal sensor to acquire electrophysiological signals of a patient; the working method of the remote monitoring system comprises the following steps:

step S10, the patient external controller judges whether a handshake signal from a patient client is received within a first time threshold, if so, the step S11 is carried out, and if not, the step S19 is carried out;

step S11, sending a response signal, and entering step S12;

step S12, the patient external controller judges whether an instruction is received within a second time threshold, if yes, the step S13 is carried out, and if not, the step S19 is carried out;

step S13, the patient external controller judges the type of the instruction, and if the instruction is a communication parameter setting instruction, the step S14 is carried out; if the command is an electrophysiological signal acquisition command, then step S15 is entered; if the command is a remote program control command, the step S16 is carried out; if the instruction is a stop instruction, directly entering step S19;

step S14, setting communication parameters, sending a communication result to the patient client and returning to the step S12;

s15, collecting electrophysiological signals, sending the collected electrophysiological signals to the remote monitoring server, and returning to the S12;

step S16, judging whether the check instruction is legal, if so, entering step S17, otherwise, returning to step S12;

step S17, sending an instruction to the implantable medical device and entering step S18;

s18, acquiring a program control result, sending the program control result to the remote monitoring server, and returning to the S12; and

step S19, indicating communication failure and ending communication.

Compared with the prior art, the working method of the remote monitoring system of the implantable medical device provided by the invention can acquire the electrophysiological signals of the patient through the electrophysiological signal sensor, the monitoring means are diversified, and the patient can be monitored more comprehensively.

Drawings

Fig. 1 is a block diagram of a remote monitoring system for an implantable medical device according to a first embodiment of the present invention.

Fig. 2 is a block diagram of a patient extracorporeal controller according to a first embodiment of the present invention.

Fig. 3 is a block diagram of a signal acquisition module of the patient extracorporeal controller according to the first embodiment of the present invention.

Fig. 4 is a frame diagram of a patient terminal according to a first embodiment of the present invention.

Fig. 5 is a frame diagram of a doctor terminal according to a first embodiment of the present invention.

Fig. 6 is a block diagram of a remote monitoring server according to a first embodiment of the present invention.

Fig. 7 is a block diagram of a remote monitoring website of the remote monitoring server according to the first embodiment of the present invention.

Fig. 8 is a block diagram of an advanced monitoring module of the remote monitoring server according to the first embodiment of the present invention.

Fig. 9 is a schematic diagram illustrating an operation principle of the av communication server according to the first embodiment of the present invention.

Fig. 10 is a flowchart illustrating the operation of the implantable medical device according to the first embodiment of the present invention.

Fig. 11 is a block diagram of a remote monitoring system for an implantable medical device in accordance with a second embodiment of the present invention.

Fig. 12 is a block diagram of a signal acquisition controller of a remote monitoring system for an implantable medical device in accordance with a second embodiment of the present invention.

Detailed Description

The remote monitoring system for an implantable medical device and the working method thereof according to the present invention will be described in detail with reference to the accompanying drawings and specific embodiments. The embodiments described in the drawings are illustrative only and should not be construed as limiting the invention.

Referring to fig. 1, a first embodiment of the present invention provides a remote monitoring system 10 for an implantable medical device 100, comprising: an implantable medical device 100, a patient external controller 200, an electrophysiological signal sensor 300, a patient client 400, a doctor terminal 500, a remote monitoring server 600, a data analysis server 700, and an audio video communication server 800. The patient external controller 200, the electrophysiological signal sensor 300 and the patient client 400 together form a patient terminal.

The implantable medical device 100 is implanted in a patient during use. The implantable medical device 100 may be a cardiac pacemaker, defibrillator, deep brain stimulator, spinal cord stimulator, vagus nerve stimulator, gastrointestinal stimulator, or other similar implantable medical device. The present invention will be described by taking only an electrical stimulator for deep brain as an example.

The patient external controller 200 is connected to the implantable medical device 100 and the patient client 400, respectively, and can perform bidirectional communication with the implantable medical device 100 and the patient client 400 and output data or instructions. The patient extracorporeal controller 200 is connected to the electrophysiological signal sensor 300 by wire or wirelessly. When the operation condition of the implantable medical device 100 is critical, the patient external controller 200 automatically determines the risk level and transmits the determination result data to the remote monitoring server 600.

As shown in fig. 2, the external controller 200 of the patient includes a first communication module 210, a second communication module 220, a third communication module 230, a signal acquisition module 240, a microprocessor 250, a display screen 260, a button and switch 270, a power management module 280, and an electrophysiological signal determination module 290.

The first communication module 210 is wirelessly connected to the implantable medical device 100, and is configured to receive the operating condition of the implantable medical device 100 and forward an instruction to the implantable medical device 100. The second communication module 220 is connected to the patient client 400, and is configured to receive an instruction from the patient client 400 and forward the operating status of the implantable medical device 100 and the electrophysiological data of the patient to the patient client 400. The third communication module 230 is connected to the remote monitoring server 600, and is configured to report a result with a higher risk identification result to the remote monitoring server 600. The signal acquisition module 240 is connected to the electrophysiological signal sensor 300, and is configured to acquire an electrophysiological signal of a patient and send the electrophysiological signal to the microprocessor 250. The signal collecting module 240 may specifically collect surface electromyogram, electrocardiograph, deep brain electrical signals, and other electrophysiological signals, but is not limited to collecting these signals. The microprocessor 250 is the control core of the patient external controller 200, and mainly includes two operation modes: a patient autonomous adjustment mode and a doctor remote monitoring mode. The microprocessor 250 is provided with an instruction input end for outputting each control key, a parameter input end for each toggle switch, an electrophysiological signal input end, and a data input and output end of a remote monitoring system. The microprocessor 250 is respectively connected to and controls the first communication module 210, the second communication module 220, the third communication module 230, the signal acquisition module 240, the display screen 260, and the key and switch 270. All components of the patient external controller 200 work under the coordination and control of the microprocessor 250, so as to realize the functions of controlling human beings and interaction, setting a communication protocol, modulating and demodulating communication data and the like.

Further, the patient external controller 200 further comprises an electrophysiological signal determination module 290. The microprocessor 250 is connected to the electrophysiological signal determination module 290. Preferably, the electrophysiological signal determination module 290 is connected in series between the microprocessor 250 and the signal acquisition module 240. The electrophysiological signal determination module 290 can simply analyze the electrophysiological signals collected by the signal collection module 240 to classify the electrophysiological signals according to different risk levels. When the risk level is low, the microprocessor 250 transmits data to the patient client 400 through the second communication module 220, and then transmits the data to the remote monitoring server 600 through the patient client 400. When the risk level is high, the microprocessor 250 directly transmits data to the remote monitoring server 600 through the third communication module 230 for timely processing by the doctor. For example, the electrophysiological signal determination module 290 calculates a cardiac rhythm data to obtain a cardiac rhythm data, and reports the cardiac rhythm data to the remote monitoring server 600 if the cardiac rhythm exceeds a normal range.

As shown in fig. 3, the signal acquisition module 240 includes a signal input interface 241, a signal sorting circuit 242 connected to the signal input interface 241, and a signal output interface 243 connected to the signal sorting circuit 242. The signal input interface 241 includes a wired interface module 2411, a wireless interface module 2412 and a selector module 2413 respectively connected to the wired interface module 2411 and the wireless interface module 2412, wherein the wired interface module 2411 is configured to receive wired inputs of the electrophysiological signals of the electrophysiological signal sensor 300 such as the surface myoelectric electrode 301 and the electrocardio-electrode 302, and the wireless interface module 2412 is configured to receive the radio physiological signals transmitted by the deep brain electrode 303 and the transmitter 304 thereof, and the wireless transmitter of the electrophysiological signal sensor 300 such as the electrocardio Holter 305. Namely, the surface myoelectric electrode and the electrocardio electrode are in wired connection with the patient external controller 200; the implanted deep brain electrode and the electrocardio Holter305 are wirelessly connected with the external controller 200 of the patient. The selector module 2413 is controlled by the microprocessor 250 to select data channels, so as to realize the acquisition of different signals. The signal sorting circuit 242 is configured to perform noise elimination and amplification processing on the acquired signal and output the signal by the signal output interface 243. The signal output interface 243 includes an analog-to-digital conversion circuit 2431 and a digital output port 2432 connected to the analog-to-digital conversion circuit 2431. The digital output port 2432 interfaces with the microprocessor 250. The electrophysiological data is forwarded to the second communication module 220 via the microprocessor 250 and finally transmitted to the remote monitoring server 600 via the patient client 400.

In one embodiment of the present invention, the first communication module 210 periodically communicates with the implantable medical device 100 to obtain the operating condition of the implantable medical device 100. The microprocessor 250 determines whether there is an obvious abnormal condition in the operating condition of the implantable medical device 100 according to the operating condition of the implantable medical device 100. When the operation status of the implantable medical device 100 is not significantly abnormal, the operation status data is sent to the patient client 400 through the second communication module 220, and then sent to the remote monitoring server 600 by the patient client 400. When the operation condition of the implantable medical device 100 is obviously abnormal or an emergency event is encountered, the program in the microprocessor 250 determines the attribute and level of the event, and if the event is an emergency event, the data is immediately sent to the remote monitoring server 600 through the third communication module 230, and the remote monitoring server 600 sends the data to the doctor terminal 500.

In an embodiment of the present invention, the patient external controller 200 and the implanted medical device 100 perform reliable bidirectional communication, and the signal channel may adopt analog modulation modes such as amplitude modulation and frequency modulation, and may also adopt digital modulation modes such as amplitude keying ASK, frequency shift keying FSK, and pulse position modulation PPM. The second communication module 220 integrates a data link interface, which serves as a communication relay between the patient client 400 and the implantable medical device 100, and receives instructions from the patient client 400. The method can be realized by adopting wired communication modes such as synchronous/asynchronous serial interfaces, USB buses and the like, and can also be realized by adopting wireless communication modes such as Bluetooth, satellites and the like. The communication mode of the third communication module 230 is a wireless communication mode, for example, wireless communication services such as wireless local area network WLAN, general packet radio service GPRS, worldwide interoperability for microwave access WiMAX, third generation mobile communication network 3G, and the like. The patient external controller 200 directly wirelessly communicates with the remote monitoring server 600 through the third communication module 230 to update the communication key.

The electrophysiological signal sensor 300 is not limited in kind, and may be one or more of a surface myoelectric electrode, an electrocardiograph electrode, an implantable deep brain electrode, an acceleration sensor, an electrocardiograph Holter, and the like. The electrophysiological signal sensor 300 is used to measure an electrophysiological signal of a patient during telemonitoring. The electrophysiological signal sensor 300 can be implanted in a patient or can be disposed outside the patient's body during use. For example, the implanted deep brain electrode is implanted into the body of a patient when in use, and the surface myoelectric electrode is arranged on the body surface of the patient when in use.

One end of the patient client 400 is connected to the patient external controller 200, and the other end is connected to the remote monitoring server 600 and the audio video communication server 800, respectively. The patient client 400 transmits the received operation condition data of the medical instrument 100 to the remote monitoring server 600, and transmits the audio-video data of the patient to the audio-video communication server 800 while receiving the audio-video data of the doctor.

Referring to fig. 4, the patient client 400 includes a microprocessor 410, an authentication component 420, a remote monitoring component 430, a communication component 440, an audio/video component 450, an audio/video capture device 460, and a power module 470.

The microprocessor 410 acts as the control core for the patient client terminal 400, and all components of the physician monitoring client operate under the coordination and control of the microprocessor 410. The identity authentication component 420 is used for performing secure authentication on a patient and includes a patient identity authentication module and a doctor identity authentication module. The patient identity authentication module is used for verifying the identity of an operator, and the patient inputs a user identification code (user ID) and a password into the identity authentication component and then carries out advanced authentication. The advanced authentication may be authentication methods such as digital signature, digital certificate, identification card or smart card identification, short message password, dynamic password, USB suspicion, biometric identification (such as voice recognition, fingerprint recognition, etc.). After some or some of the above advanced authentications, the patient identity authentication is completed. The doctor identity authentication module is used to query the database of the remote monitoring server 600 and provide the authenticated doctor status to the authenticated patient. The patient can initiate a remote monitoring request to the doctor who passes the identity authentication, the doctor establishes a remote monitoring connection after agreeing, the patient enters the remote monitoring component, and the remote monitoring is received while audio and video interaction is carried out on the patient and the doctor. In this embodiment, advanced identity authentication is performed by combining a digital certificate and a short message password, and the patient client 400 needs to provide a valid digital certificate and a valid short message password to the remote monitoring server 600 to pass verification.

The remote monitoring module 430 is used to provide a remote monitoring and programming interface for the patient, and is connected to the remote monitoring server 600 and the audio video communication server 800 through the communication module 440 under the control of the microprocessor 410. The remote monitoring component 430 provides a display screen, a key or a keyboard and other operation devices and a visual image operation interface. After the doctor sends the remote monitoring instruction through the doctor terminal 500, the remote monitoring server 600 forwards the remote monitoring instruction to the remote monitoring component 430 of the patient client 400 to determine the type of the instruction, for example: a status detection instruction of the implantable medical device 100, a parameter programming instruction, a patient electrophysiological data acquisition instruction, and the like. Are packaged according to different instruction types according to a protocol agreed upon with the patient external controller 200 and forwarded to the patient external controller 200 via a local communication module of the communication component 440. The patient external controller 200 analyzes the instruction and then communicates with the implantable medical device 100 or the electrophysiological signal sensor 300 to complete the execution of the instruction. The instruction execution result is forwarded to the remote monitoring component 430 through the communication module 440 and is presented on a display screen in a friendly interface form. The remote monitoring component 430 further transmits the working status, the patient electrophysiological data or the parameter programming result obtained by communication to the remote monitoring server 600 through the network communication module of the communication component 440 for the doctor to view. The remote monitoring module 430 mainly includes remote monitoring related functions such as graphically displaying operating parameters and states of the implantable medical device 100, receiving a remote monitoring instruction, invoking a patient controller to execute the instruction, uploading an instruction execution result, and the like, and is a functional core of a remote monitoring patient terminal.

The communication component 440 serves as a communication interface for the patient remote monitoring terminal, and includes an encryption module and a communication module. The encryption module is used for encrypting all data sent by the communication component, and may be a symmetric encryption algorithm or an asymmetric encryption algorithm, in this example, the data to be sent to the remote monitoring server 600 is encrypted by using an RSA asymmetric encryption method, and the encryption key is periodically synchronized by the network communication module and the remote monitoring server. The communication module comprises a network communication module and a local communication module, wherein the network communication module is connected with the remote monitoring server and the audio/video communication server in a wired or wireless mode, and the network mode can be any access mode of similar network communication services such as a local area network, a metropolitan area network, a wide area network, the internet, a wireless broadband network, a Wireless Local Area Network (WLAN), a General Packet Radio Service (GPRS), a Worldwide Interoperability for Microwave Access (WiMAX), a third generation mobile communication network 3G, a fourth generation mobile communication network 4G and the like. The present example employs broadband network access. The local communication module is connected with the patient controller in a wired or wireless mode, maintains data exchange between the patient client and the patient controller, and can be realized by adopting communication modes such as a synchronous/synchronous serial interface, a Universal Serial Bus (USB) or Bluetooth, and the like, wherein the embodiment adopts a Bluetooth 4.0 communication mode.

The audio-video component 450 is used to establish real-time audio-video communication with a physician. The audio/video component 450 and the remote monitoring component 430 share a display screen and keys, and are provided with a loudspeaker and a 3.5mm earphone interface (refer to international standard CTIA or national standard OMTP). The patient initiates a video communication request to the audio and video communication server 800 through the audio and video component 450, the doctor receives the request by clicking a key to respond, the audio and video communication server 800 establishes bidirectional communication and generates an identity after a requester agrees with a receiver, then the audio and video component 450 performs real-time audio and video communication with the doctor in a remote monitoring process by adopting an audio and video communication protocol (such as rtmp, rimfp, SIP and H.264) forwarded by a P2P or a server, different video resolutions can be selected according to network conditions in the communication process, and three gears are available: high definition 720p, standard definition 480p, fluent 320p.

The audio and video acquisition device 460 is used for capturing audio and video of a doctor for the audio and video component to call. In this example, the device may be a portable digital camera (e.g., 640px. 480px, interface mode USB 2.0), a portable computer-integrated digital camera, or a camera device of an intelligent terminal. The power management module 470 stabilizes the battery voltage to 5V to power the microprocessor 410 and the components, boosts the battery voltage to 9V to power the communication component 440, and controls the charging input to charge the battery. In this example, the UI display and operation of the patient client 400 is controlled by dedicated Winform client software running in the microprocessor 410, developed using the.Net framework 4.0.

The doctor terminal 500 is connected to the remote monitoring server 600 and the audio video communication server 800, respectively. The doctor terminal 500 receives and monitors the operation status of the implantable medical device 100, obtains the electrophysiological signals and data analysis results of the patient, and also sends the audio and video data of the doctor to the audio and video communication server 800, while receiving the audio and video data of the patient.

Referring to fig. 5, the doctor terminal 500 includes a microprocessor 510, an authentication component 520, a remote monitoring component 530, a communication component 540, an audio/video component 550, an audio/video capture device 560, and a power module 570.

The microprocessor 510 serves as the core of the doctor terminal 500, and all components of the doctor monitoring client operate under the coordination and control of the microcontroller 510. The identity authentication component 520 is used for performing safety authentication on doctors and limiting the authority of different doctors according to the authentication result, and comprises a doctor identity authentication module and a patient identity authentication module. The doctor identity authentication module is used for verifying the identity of an operator, and after a doctor inputs a user identification code (user ID) and a password to the identity authentication component, advanced authentication is performed. In this embodiment, the identity authentication component adopts an advanced authentication mode combining a digital certificate and a short message password, the digital certificate is issued by the remote monitoring server 600, the doctor terminal 500 can access the remote monitoring server 600 only if a legal digital certificate is installed, and the short message password is sent to a mobile phone or other mobile intelligent devices of the doctor by the remote monitoring server 600.

According to different authentication results, the remote monitoring component limits the operation authority of the doctor. In this example, the primary monitoring physician (e.g., clinical specialist, nurse) can only use the primary monitoring module in the remote monitoring component 530. A high level monitoring physician (e.g., a neurosurgeon, an attending physician, etc.) may use the primary and high level monitoring modules of the remote monitoring assembly 530. In addition, the authentication result limits doctors with different levels to be responsible for patient lists with different ranges, in this example, a doctor in the program control main center can program all patients responsible for the center, and a doctor in the sub-center can only program and distribute the administered patients.

In embodiments of the invention where a high-level physician corresponds to a plurality of patients, when there are patients or a plurality of patients requesting high-level monitoring, the medical professional may choose to approve the request of one patient and may agree with the request of the next patient only after the connection with the current patient is disconnected. After the connection is agreed, the patient currently monitored by the professional doctor is recorded in the database of the remote monitoring server 600, and the page jumps to the high-level monitoring module after the connection is successful.

The remote monitoring component 530 is used to provide a remote monitoring and programming interface for the doctor, and is connected to the remote monitoring server 600 through the communication component 540 under the control of the microprocessor 510. The remote monitoring component 530 provides a display screen, a key or a keyboard and other operation equipment, a visual image operation interface, and provides a remote monitoring operation interface for a doctor. The remote monitoring module comprises a primary monitoring module and an advanced monitoring module. The primary monitoring module is used to perform simple status query functions (e.g., telemetry, battery charge query, patient information query, etc.) on its implanted medical device 100.

In one embodiment of the invention, the primary doctor enters the primary monitoring module and displays all the events to be processed, and the primary doctor processes the events according to the urgency of the events (the urgency is the same, and the events are processed according to the time sequence). For higher-urgency events, such as the implantable medical device operating parameter exceeding the normal range, the patient electrophysiological data exceeding the normal range, etc., the primary physician immediately sends a command to the patient terminal to shut down or initiate a safe operating mode. The patient's primary monitoring request is processed by the primary physician as an event including a basic operating status query for the implantable medical device, a daily maintenance recommendation, a charge reminder, a battery replacement reminder, a security key update, etc. In the case of less urgent events, such as a work report submitted by the patient's external programmer on an on-schedule basis, the primary physician may analyze the work report, advise the patient whether to change batteries or require recharging, whether to perform advanced monitoring, etc., based on operating specifications. The advanced monitoring module is used to display patient information of a medical professional, perform complex programming on the implantable medical device 100, and read and analyze electrophysiological data of a patient, and the detailed functions thereof will be described with reference to fig. 8.

In this example, the operation logic, data structure and interface display of the identity authentication component 520 and the remote monitoring component 530 are controlled by ASP website built inside the remote monitoring server, and the website adopts MVC three-layer architecture of Net frames 4.0. The doctor terminal 500 performs identity authentication, remote monitoring operation, and data query and entry through a browser.

The audio-visual component 550 is used to establish real-time audio-visual communication with the patient. The audio/video component 550 may share a display screen and buttons with the remote monitoring component 530, a speaker and a 3.5mm headphone interface (refer to international standard CTIA or national standard OMTP). The patient initiates a video communication request to the audiovisual communication server 800 through the audiovisual component 550 with similar functionality. The audio and video component 550 calls the communication component 540 through a microprocessor to acquire a communication request of a patient from a server, a doctor receives the request by clicking a key to respond, the audio and video communication server 800 establishes two-way communication and generates an identity after a requester agrees with a receiver, and then the audio and video component 550 performs real-time audio and video communication with the patient in a remote monitoring process by adopting an audio and video communication protocol (such as rtmp, rimfp, SIP and H.264) forwarded by a P2P or server.

The audio/video component 550 has video recording and uploading functions, and can record and upload videos of patients in a program control process to the remote monitoring server 600 to be stored as medical record data of the patients. The audio/video component 550 also has a video communication media stream control, so that doctors and patients can select to perform high-definition two-way audio/video communication, standard-definition two-way audio/video communication, smooth two-way audio/video communication, two-way audio communication for receiving the video of patients and only two-way audio communication between doctors and patients according to network conditions, wherein the resolution of the video high-definition communication sent by the doctors is 720p, the standard-definition resolution is 480p, and the smooth resolution is 320p. In this example, the User Interface (UI) of the audio/video component 550 is graphical operating software running in the microprocessor, and has operating keys and a video display window for adjusting definition, connecting a doctor, disconnecting a connection, and the like. In this example, the audio/video component software part uses a WebRTC framework and communicates based on a WHATWG protocol. The audio/video capture device 560 is used to capture the audio and video of the doctor for the audio/video component 550 to call. In this example, the device may be a portable digital camera (e.g., 640px. 480px, interface mode USB 2.0), a portable computer-integrated digital camera, or a camera device of an intelligent terminal.

The communication component 540 serves as a communication interface of the doctor terminal 500, and is bidirectionally connected to the microprocessor 510, so as to realize data transmission between the doctor terminal 500 and the remote monitoring server 600 and between the doctor terminal and the audio/video communication server 800. The communication component 540 includes an encryption module and a communication module: the encryption module is used for encrypting all data transmitted by the network communication assembly, a hardware encryption circuit is adopted and is matched with a microprocessor to realize encryption, the encryption method can be symmetric encryption or asymmetric encryption, and an encryption key is periodically synchronized with a server; the communication module comprises a wired communication module and a wireless communication module, and can be accessed to the remote monitoring server through any one of similar network communication services such as a local area network, a metropolitan area network, a wide area network, the internet, a wireless broadband network, a Wireless Local Area Network (WLAN), a General Packet Radio Service (GPRS), worldwide Interoperability for Microwave Access (WiMAX), a third generation mobile communication network 3G, a fourth generation mobile communication network 4G and the like. The power management module 17 stabilizes the battery voltage to 5V to supply power to the microprocessor 510 and the components, boosts the battery voltage to 9V to supply power to the communication component 540, and controls the charging input to charge the battery.

The remote monitoring Server 600 establishes a database to store relevant information, such as SQL Server, mySQL, XML files, and the like. One end of the remote monitoring server 600 is connected to the patient client 400, and the other end is connected to the doctor terminal 500. The remote monitoring server 600 is directly connected to the patient external controller 200, and can directly obtain the operation status of the implantable medical device 100 and the related electrophysiological data of the patient from the patient external controller 200. When the patient external controller 200 determines a critical situation, it directly reports to the remote monitoring server 600 so that the doctor can make a faster response.

The remote monitoring server 600 is further connected to the data analysis server 700, and exchanges data with the data analysis server 700. The data analysis server 700 is configured to perform online or offline analysis on the electrophysiological data of the patient, obtain an evaluation result with reference meaning by using analysis methods such as linear analysis, nonlinear analysis, and machine learning, and push the evaluation result to the doctor terminal 500. The linear analysis includes amplitude analysis, frequency analysis, power spectrum analysis, wavelet transform analysis, and the like. The nonlinear analysis comprises statistical analysis, chaos theory analysis and the like. The machine learning comprises SVM classification, neural network calculation and the like. In an embodiment of the present invention, the data analysis server 700 is configured to analyze epidemiological and clinical data of a patient, count and evaluate health status of the patient and specificity of the implantable medical device 100 by using machine learning and artificial intelligence methods, obtain an evaluation result with reference significance, and push the evaluation result to the doctor terminal 500.

In one embodiment of the present invention, the data analysis server 700 uses microsoft WCF framework and is connected to the remote monitoring server 600 through a local area network. When a doctor needs to analyze, the remote monitoring server 600 calls a calculation interface of the data analysis server 700, transmits data information to the data analysis server 700, obtains a calculation result, and displays the calculation result on the doctor terminal 500.

In one embodiment of the present invention, the audiovisual communication server 800 is used to maintain video communication between a physician and a patient during a remote monitoring process. The audio and video communication server 800 is composed of a signaling server and a forwarding server. The signaling server has an algorithm for firewall traversal, such as STUN traversal technology, ALG traversal technology, and the like, and can perform NAT traversal on the audio and video components of the doctor terminal 500 and the patient client 400 when establishing connection. The audiovisual communication server 800 preferably attempts to establish a peer-to-peer connection and firewall traversal between the physician client audio video communication component 530 and the patient client audio video communication component 430 through a signaling server when selecting the connection mode. If the establishment is successful, the audio and video data are directly transmitted between the two audio and video components without being forwarded by the server. If the establishment fails, such as firewall blocking or other reasons, transmission is attempted through the forwarding server as a relay of the video communication data. In one embodiment of the invention, the audio and video communication mode can be point-to-point or server forwarding, and the transmission protocol can be rtmp, rimfp, SIP, H.264 and the like;

in one embodiment of the present invention, the doctor terminal audio video communication component 530 is supported to record the video of the patient undergoing remote program control and upload the recorded video to the remote monitoring server for storage as the electronic medical record data of the patient.

As shown in fig. 6, the remote monitoring server 600 includes a processor 610, a storage device 620, a network interface 630, a wireless network card 640 and a GSM module 650. The processor 610 is configured to run a program for remotely monitoring a website. The memory 620 is used to store programs and data for the physician, patient, and the implantable medical device 100. The network interface 630 is used to provide a communication interface for the patient client 400 and the doctor terminal 500. The wireless network card 640 is used for the processor to provide a communication interface with the patient external controller 200. The GSM module 650 is used to send messages to the mobile communication device of the patient or doctor.

In one embodiment of the present invention, the doctor terminal 500 and the patient client 400 access the remote monitoring server 600 through the network interface 630, respectively, and access the remote monitoring server 600 using the respective clients. When the implantable medical device 100 is abnormal, the operation status data of the implantable medical device 100 is sent to the remote monitoring server 600 through the wireless network card 640 for timely processing. When the patient or doctor is not on-line, the request of the requesting party is sent to the mobile communication device of the requested party through the GSM module 650 for data interaction.

In an embodiment of the present invention, the doctor terminal 500, the patient client 400 and the remote monitoring server 600 employ certain network security technologies to ensure communication security, for example, a virtual private network VPN tunnel technology is used for connection, and protocols such as LTF, LT2F, SSL, etc. may be employed in the transport layer. In an embodiment of the invention, the remote monitoring website is realized by adopting an MVC three-layer architecture, wherein an M (Model) layer is responsible for database reading and writing, a V (View) layer is responsible for page design, and a C (Control) layer is responsible for website logic Control. In one embodiment of the present invention, the remote monitoring website is implemented by a high-speed network, and any one of a local area network, a metropolitan area network, a wide area network, and the internet may be used. The remote monitoring website accepts the access of a host connected to the same network after being released on the network, and the release of the website can be realized by adopting website server release software, such as Apache, IIS, netBox and the like.

As shown in FIG. 7, the remote monitoring website includes a login module 611, an appointment module 612, a patient information module 613, a primary physician information module 614, a professional physician information module 615, a primary monitoring module 616, and a high-level monitoring module 617. The login module 611 is configured to check the identities of the login users according to the stored information of the patient and the doctor in the database, and the patient and the doctor respectively enter their respective information modules after the check is successful. The appointment module 612 is used for appointments between doctors and patients before remote monitoring. In this example, if the patient needs to receive the conventional remote monitoring, the reservation request is sent in advance in the reservation module, the request includes the information of the designated doctor and the monitoring mode, after the doctor receives the request, if the reservation is agreed, the both parties agree to complete, and the remote monitoring can be performed at the appointed time. The patient information module 613 is used for the patient to log in the remote server to perform audio-video interaction with the doctor and obtain monitoring detection.

In one embodiment of the invention, after the patient successfully logs in, the personal information of the patient is displayed on a page, and whether the professional doctor of the patient is on line or not is detected. If the current offline of the professional doctor is displayed, the patient cannot receive advanced monitoring, and the patient can choose to request primary monitoring or directly send information to the mobile communication equipment of the professional doctor, such as a mobile phone, a palm computer and the like. When the patient chooses to send a request to the mobile communication device of the medical professional, then the request is sent by the GSM module 650 of the remote monitoring server 600 to the terminal or mobile device of the medical professional. The medical professional can inform the patient of the response by replying a message to the remote monitoring server 600. If the professional doctor is on line, the patient can directly initiate a high-level monitoring request to establish connection, at the moment, the patient information module enters a waiting instruction state, and if a program control instruction exists, an interface is called to execute the instruction. Meanwhile, the patient external controller 200 starts to collect electrophysiological signals of the patient, including surface electromyography, electrocardio-signal and deep brain electrical signal of the patient, according to the requirements of the professional doctor, and these data are transmitted to the remote monitoring server 600 through the patient client 400 together with the return data of the implanted medical device 100.

The primary physician information module 630 is used for the primary physician to process the patient assigned by the system. In an embodiment of the present invention, the primary doctor registers its own status as working on the remote monitoring server 600 through the operation interface, and the remote monitoring server 600 allocates a certain event to be processed to the primary doctor, so as to enter the primary monitoring module. The specialist information module 640 is used for displaying patient information of a specialist and performing audio-video interaction with a patient.

In an embodiment of the present invention, the professional doctor information module 614 refreshes the online status of the patient for which the doctor is responsible, and accesses the database of the remote monitoring server 600 to obtain the name of the patient, whether the patient is online, whether a high-level monitoring request is initiated, and the like.

In an embodiment of the invention, one medical professional corresponds to a plurality of patients. When there is a patient or a plurality of patients requesting advanced monitoring, the practitioner can choose to approve the request of one patient and can approve the request of the next patient only after the connection to the current patient is broken. After the connection is approved, the patient currently monitored by the professional doctor is recorded in the database of the remote monitoring server 600, and the page jumps to the high-level monitoring module 616 after the connection is successful. The advanced monitoring module 616 is used for advanced telemonitoring of the implantable medical device 600.

In one embodiment of the present invention, the primary physician enters the primary monitoring module 615 and displays all pending events. The junior physicians handle the event according to its urgency (the same urgency is followed by a chronological order). For more urgent events, such as the implantable medical device 100 operating parameters exceeding normal ranges, etc., the primary physician immediately sends an instruction to the patient extracorporeal controller 200 to shut down or initiate a safe operating mode. The primary monitoring request of the patient is processed by the primary doctor as an event, and the patient can receive primary monitoring of the primary doctor, including basic working state inquiry, daily maintenance suggestion, charging reminder, battery replacement reminder, safety key updating and the like of the implantable medical device. In the event of a less urgent event, such as a work report submitted by the patient external controller 200 on schedule, the primary physician may analyze the work report, advise the patient whether to replace the battery or require recharging, whether to perform advanced monitoring, etc., based on operating specifications.

In one embodiment of the present invention, the primary doctor performs security maintenance on the patient external controller 200 through the primary monitoring module 615, and updates the communication key between the patient external controller 200 and the remote monitoring server 600. The junior doctor transmits information to inform the patient that the patient needs to be informed (the patient does not need to log in to the remote monitoring server) to the remote monitoring server 600 through the doctor terminal 500, and the remote monitoring transmits information to the mobile communication device of the patient through the GSM module 650.

The advanced monitoring module 617 is configured to perform audio/video delivery on a patient of a medical professional, send a telemetry command to obtain operating condition data of the implantable medical device 100, send a programming command to program the implantable medical device 100, and obtain a real-time electrophysiological signal of the patient.

As shown in fig. 8, the advanced monitoring module 617 includes a raw electrophysiological data module 6171, an electrophysiological data analysis module 6172, an operating status monitoring module 6173, an operating parameter programming module 6174, and a monitoring parameter and patient status query/save module 6175. The raw electrophysiological data module 6171 is configured to display the raw electrophysiological signal collected by the patient client 400. The electrophysiological data analysis module 6172 is configured to invoke a computing interface of the data analysis server 700, analyze the electrophysiological data of the patient using linear analysis, nonlinear analysis, machine learning, and other analysis methods, and present an analysis result of the electrophysiological data of the patient to a physician, thereby assisting the physician in evaluating symptoms of the patient during the remote program control process. The electrophysiological data analysis module 6172 calls the computing interface of the data analysis server 700, and utilizes the patient's flow and pathology statistics, clinical data, etc. to perform expert scoring, evaluate the health status of the patient and the specificity of the implantable medical device 100, and the results are presented to the doctor to help the doctor to implement a personalized treatment. The operation status monitoring module 6173 is configured to display a current operation status of the implantable medical device 100, and after a medical professional enters the advanced monitoring module 617 to establish a video connection with a patient, the medical professional performs telemetry through the advanced monitoring module 617 to obtain current operating parameters and status of the implantable medical device 100 in the patient. The operating parameter programming module 6174 is configured to send a programming command to the remote implantable medical device 100, including parameter setting, information setting, working mode setting, clock calibration and other programming commands. The monitoring parameter and patient status query/save module 6175 is used to provide an interface for querying/storing an electronic medical record database, and a doctor can query the patient history program control parameters and the severity or improvement degree of patient symptoms under the parameters through the monitoring parameter and patient status query/save module 6175. The monitoring parameter and patient status query/storage module 6175 may store a certain working parameter combination of the implantable medical device 100 and the corresponding patient symptoms thereof at any time during remote programming. For example, in this example, the physician can query the historical programming parameters (amplitude, frequency, pulse width, etc.) of the implantable neurostimulator 100 and its corresponding patient symptoms and save a new programming record through the monitoring parameter and patient status query/save module 6175.

As shown in fig. 9, the patient terminal audio video data acquisition device 420 captures local sounds and images, presents them in a designated area, and the patient terminal audio video communication component 430 connects to the audio video communication server 800 through an IP address, sends a peer-to-peer protocol connection request, and after the connection is successful, acquires an ID returned by the audio video communication server 800 as an identification for communication with other terminals. Similarly, the doctor terminal audio and video data acquisition device 520 captures local sounds and images, presents the local sounds and images in a designated area, and the doctor terminal audio and video communication component 530 connects to the audio and video communication server 800 through an IP address, sends a peer-to-peer protocol connection request, and after the connection is successful, acquires an ID returned by the audio and video communication server 800 as an identification for communication with other terminals. The patient terminal audio and video communication component 430 publishes a local audio and video stream on the network, and the local audio and video stream is used as a publisher to wait for the doctor terminal audio and video communication component 530 to subscribe, and the doctor terminal audio and video communication component 530 obtains the identity ID of the publisher, so as to subscribe the audio and video stream of the publisher. The doctor terminal audio and video communication component 530 publishes its own audio and video stream information on the network while subscribing, and the patient terminal audio and video communication component 530 makes a reverse subscription to subscribe the doctor's audio and video stream, so as to realize bidirectional audio and video communication, after the communication is successfully established, the audio and video communication server 800 has no data transfer, and the data of the audio and video communication is directly transmitted among the audio and video communication components.

The audio and video data acquisition devices of the patient client 400 and the doctor terminal 500 capture sound and images, the audio and video communication components of the patient client 400 and the doctor terminal 500 are respectively connected to the audio and video communication server 800, and the patient and the doctor perform audio and video communication through the audio and video communication components.

The remote monitoring system 10 of the implantable medical device 100 according to the embodiment of the present invention integrates the electrophysiological signal sensor 300 and the data analysis server 700, so that the electrophysiological signal of the patient can be collected by the electrophysiological signal sensor 300, and the collected electrophysiological signal can be analyzed by the data analysis server 700 and the analysis result can be sent to the doctor for reference. Therefore, the remote monitoring system 10 is simple to operate, has various monitoring means, and can monitor patients more comprehensively.

The operation of the remote monitoring system 10 of the implantable medical device 100 of the present embodiment will now be described. It is to be understood that the embodiments of the present invention are merely illustrative of the manner in which the remote monitoring system 10 operates in connection with the electrophysiological signal sensor 300.

Referring to fig. 10, the method of operating the patient extracorporeal controller 200 of the remote monitoring system 10 of the present invention includes the steps of:

step S10, judging whether a handshake signal from the patient client 400 is received within a first time threshold, if yes, entering step S11, and if not, entering step S19;

step S11, sending a response signal, and entering step S12;

step S12, judging whether an instruction is received within a second time threshold, if yes, entering step S13, and if not, entering step S19;

step S13, judging the type of the instruction, and if the instruction is a communication parameter setting instruction, entering step S14; if the command is an electrophysiological signal acquisition command, the method goes to step S15; if the command is a remote program control command, the step S16 is carried out; if the instruction is a stop instruction, directly entering step S19;

step S14, setting communication parameters, sending a communication result to the patient client 400 and returning to step S12;

step S15, collecting electrophysiological signals, sending the collected electrophysiological signals to the remote monitoring server 600, and returning to step S12;

step S16, judging whether the checking instruction is legal, if so, entering step S17, and if not, returning to step S12;

step S17, sending an instruction to the implantable medical device 100 and proceeding to step S18;

step S18, obtaining a program control result, sending the program control result to the remote monitoring server 600, and returning to step S12; and

step S19, indicating communication failure and ending communication.

In step S10, the determination of whether the handshake signal is received within the first time threshold refers to a determination of whether the second communication module 220 receives the handshake signal of the patient client 400. The first time threshold may be set as desired. In this embodiment, the first time threshold is 5 minutes.

In step S11, the sending the response signal refers to sending the response signal to the patient client 400 through the second communication module 220.

In step S12, the determination of whether the instruction is received within the second time threshold refers to a determination of whether the instruction of the patient client 400 is received by the second communication module 220. The second time threshold may be set as desired. In this embodiment, the second time threshold is 20 seconds.

In the step S13, the microprocessor 250 performs the step of determining the type of the instruction.

In step S14, the setting of the communication parameters refers to setting of communication parameters between the patient external controller 200 and the patient client 400, such as a communication mode, a baud rate, a verification mode, a master-slave mode, a wakeup mode, a transmission power, a sleep mode, and the like.

In the step S15, the acquiring the electrophysiological signals refers to the signal acquisition module 240 acquiring the electrophysiological signals of the patient through the electrophysiological signal sensor 300. The step S15 of sending the acquired electrophysiological signals to the remote monitoring server 600 further includes the steps of:

step S151, simply analyzing the collected electrophysiological signals through the electrophysiological signal discrimination module 290, and classifying according to different risk levels;

step S152, when the risk level is low, sending data to the patient client 400 through the second communication module 220, and then sending the data to the remote monitoring server 600 through the patient client 400; and

step S153, when the risk level is higher, directly sending the data to the remote monitoring server 600 through the third communication module 230, so that the doctor can process the data in time.

The risk level may be set as desired. For example: setting the heart rate to last 5% -15% beyond the normal range is a lower risk, and setting the heart rate to last 15% beyond the normal range is a higher risk, and needs advanced monitoring or visit to a nearby hospital immediately. Also for example: setting the normalized energy of the 4Hz-6Hz frequency component of the surface electromyographic signal to be less than 30%, and setting the surface electromyographic signal to continuously show no or slight tremor or stiffness as no risk; the normalized energy of the 4Hz-6Hz frequency component of the surface electromyogram signal is more than 30% and less than 60%, and the surface electromyogram signal continuously presents moderate tremor or stiffness with lower risk; the normalized energy of the 4Hz-6Hz frequency component of the surface electromyogram signal is more than 60%, and the surface electromyogram signal continuously presents severe tremor or stiffness as a higher risk.

Further, in step S15, if the signal collecting module 240 cannot collect the electrophysiological signals of the patient through the electrophysiological signal sensor 300, the microprocessor 250 sends a report to the remote monitoring server 600 for the doctor to process in time.

In step S16, the microprocessor 250 acquires a check code from the remote monitoring server 600 through the third communication module 230, so as to determine whether the remote program control command is legal.

In step S17, a command is sent to the implantable medical device 100 through the first communication module 210.

In step S18, sending the program control result to the remote monitoring server 600 further includes the following steps:

step S181, performing simple analysis on the program control result through the microprocessor 250, and classifying according to different risk levels;

step S182, when the risk level is low, sending the program control result to the patient client 400 through the second communication module 220, and then sending the program control result to the remote monitoring server 600 through the patient client 400; and

step S183, when the risk level is higher, directly sending the program control result to the remote monitoring server 600 through the third communication module 230, so that the doctor can process the program control result in time. For example, if the operating voltage of the implantable medical device 100 is greater than 2.9V, there is no risk if the voltage is less than 2.9V and greater than 2.7V, there is a lower risk if the voltage is less than 2.7V, and there is a higher risk if the voltage is less than 2.7V, it is necessary to immediately contact the general control center to stop the operation of the implantable medical device 100 or replace the battery.

In step S19, a communication failure is indicated through the display screen 260.

Further, the operation method of the remote monitoring system 10 of the present invention further includes the following steps:

step S20, the remote monitoring server 600 transmits the received electrophysiological signal to the data analysis server 700;

step S21, the data analysis server 700 analyzes and processes the electrophysiological signal and feeds back the analyzed result to the remote monitoring server 600; and

in step S22, the remote monitoring server 600 sends the result to the doctor terminal 500, and presents the result to the doctor through the doctor terminal 500.

In step S21, the method for analyzing the electrophysiological signal by the data analysis server 700 includes analysis methods such as linear analysis, nonlinear analysis, and machine learning.

Taking the surface electromyogram signal of a parkinson patient as an example, the method for performing online operation processing on the collected surface electromyogram data through the data analysis server 700 includes the following steps:

step S211, performing noise elimination filtering on the surface electromyogram signal;

step S212, normalizing the surface electromyogram signal, which follows a normalization formula:

wherein x is original surface electromyography data, x _i For each acquisition point of the raw data, SEMG is normalized surface electromyography data. The processed SEMG signal is used for depth calculation; and

step S213, calculating an overall condition score, which follows the formula:

U＝ω ₁ ·RMS+ω ₂ ·MDF+ω ₃ ·Kur+ω ₄ ·Samp+ω ₅ ·Efreq+ω ₆ REC

wherein, RMS is normalized effective value of surface electromyogram signal, and the calculation method is:

MDF is the intermediate frequency of the surface electromyogram signal, and after the power spectrum estimation of the signal is calculated by adopting a numerical calculation method, the frequency which divides the power spectrum area into two is found to be the intermediate frequency;

kur is the kurtosis coefficient, which is calculated as:

samp is sample entropy;

efreq is the total energy of the frequency components of the myoelectricity of the Parkinson patient from 3Hz to 10Hz, and the calculation formula is as follows:

REC is a data regression rate index in the recursive quantitative analysis;

ω ₁ ～ω ₆ the weight sequence for each patient can be obtained by the data analysis server 700 through comparison learning of the historical medical record and the historical surface electromyography data of the patient by using algorithms such as linear analysis, nonlinear analysis, machine learning, and the like. Under this weight, the composite score U calculated by the data analysis server 700 has the largest correlation coefficient with the parkinsonian unified rating scale (UPDRS) score in the patient medical record. The optimized selected sequences are stored in the data analysis server 700 according to the patient's IP for later use in online computing.

In this embodiment, the data analysis server 700 is utilized to perform weight analysis and index calculation on 7 parkinson patients with marked tremor symptoms, and the analysis result shows that the significance of the U value calculation model can reach 0.96 (p < 0.1) under the finally selected weight, and the U value calculation model can be used as an effective online evaluation means. It can be understood that each index calculated by various analysis methods (time domain analysis, frequency domain analysis, nonlinear analysis and the like) is related to the score of the Parkinson unified scale through a weighting calculation method, so that the method has obvious reference significance for doctors, and can express the behavioral symptoms of patients through the analysis of electrophysiological signals.

In the step S22, the remote monitoring server 600 presents the analysis result of the electrophysiological signal on the audio/video component 550 of the doctor terminal 500 in the form of a web page. Specifically, the results are presented in the advanced monitoring module 617 of the remote monitoring website. The physician can determine whether to perform parameter adjustment or shutdown processing or the like on the implantable medical device 100 in the patient based on the analysis result of the electrophysiological signal.

Further, in the step S22, the remote monitoring server 600 stores the analysis result of the electrophysiological signal in the monitoring parameter and patient status query/storage module 6175. The remote monitoring server 600 compares the analysis result of the data analysis server 700 with the analysis result stored in the monitoring parameter and patient status query/storage module 6175, and presents the comparison analysis result to the doctor.

It is to be understood that, in the step S22, the remote monitoring server 600 may not send the result to the doctor terminal 500, but automatically select a common parameter in the stored patient medical record information according to the analysis result of the data analysis server 700, and send a parameter adjustment or shutdown instruction to the implantable medical device 100.

Referring to fig. 11, a second embodiment of the present invention provides a remote monitoring system 20 for an implantable medical device 100, comprising: an implantable medical device 100, a patient external controller 200, an electrophysiological signal sensor 300, a signal acquisition controller 900, a patient client 400, a doctor terminal 500, a remote monitoring server 600, a data analysis server 700, and an audio video communication server 800. Wherein the patient external controller 200, the electrophysiological signal sensor 300 and the patient client 400 together form a patient terminal.

The remote monitoring system 20 of the implantable medical device 100 according to the second embodiment of the present invention has substantially the same structure as the remote monitoring system 10 of the implantable medical device 100 according to the first embodiment of the present invention, except that the remote monitoring system 20 further includes a signal acquisition controller 900, the electrophysiological signal sensor 300 is connected to the signal acquisition controller 900, but not to the patient external controller 200, and is connected to the patient client 400 and the remote monitoring server 600 through the signal acquisition controller 900, respectively. That is, in the first embodiment of the present invention, the signal acquisition controller 900 is integrated with the patient extracorporeal controller 200.

It is understood that in the second embodiment of the present invention, the signal acquisition module 240 is not required to be disposed inside the controller 200. Since the electrophysiological signal sensor 300 does not need to be connected to the patient external controller 200, the signal acquisition controller 900 is only required to be carried along with the patient during the process of being remotely monitored, and the patient external controller 200 does not need to be carried along with the patient.

Specifically, referring to fig. 12, the signal acquisition controller 900 includes a first communication module 910, a second communication module 920, a microprocessor 930, and a signal acquisition module 940. The first communication module 910 is configured to communicate with the patient client 400, and the second communication module 920 is configured to communicate with the remote monitoring server 600. The microprocessor 930 selects and controls the electrophysiological signal sensor 300 to acquire different physiological signals via the signal acquisition module 940. The signal collection module 940 has the same structure as the signal collection module 240.

Further, the signal acquisition controller 900 further includes an electrophysiological signal determination module 950. The microprocessor 930 is connected to the electrophysiological signal determination module 950. Preferably, the electrophysiological signal determination module 950 is connected in series between the microprocessor 930 and the signal acquisition module 940. The electrophysiological signal determination module 950 is structurally identical to the electrophysiological signal determination module 290.

The remote monitoring system 20 operates in a manner substantially the same as the remote monitoring system 10, except that the electrophysiological signal sensor 300 is controlled by the signal acquisition controller 900 to acquire and transmit electrophysiological signals of a patient.

The remote monitoring system of the implantable medical device provided by the invention has the following advantages. First, by collecting the electrophysiological signals of the patient through the electrophysiological signal sensor 300, the monitoring means are diversified, and more comprehensive monitoring of the patient can be achieved. Secondly, the data analysis server 700 is used for performing online analysis on the electrophysiological data of the patient and presenting the analysis result to the doctor, so that the monitoring of the patient is safer and more effective.

In addition, other modifications within the spirit of the invention may occur to those skilled in the art, and such modifications within the spirit of the invention are intended to be included within the scope of the invention as claimed.

Claims

1. A method of operating a remote monitoring system for an implantable medical device, the remote monitoring system comprising: the system comprises a doctor terminal, a remote monitoring server, an audio and video communication server, a data analysis server, a patient client, a patient external controller, an implanted medical apparatus and an electrophysiological signal sensor; the patient in-vitro controller comprises a signal acquisition module for controlling the electrophysiological signal sensor to acquire electrophysiological signals of the patient; the working method of the remote monitoring system comprises the following steps:

step S11, sending a response signal, and entering step S12;

step S13, the patient external controller judges the type of the instruction, and if the instruction is a communication parameter setting instruction, the step S14 is executed; if the command is an electrophysiological signal acquisition command, then step S15 is entered; if the command is a remote program control command, the step S16 is carried out; if the instruction is a stop instruction, directly entering step S19;

s18, acquiring a program control result, sending the program control result to the remote monitoring server, and returning to the S12;

step S19, indicating communication failure and ending communication;

step S20, the remote monitoring server transmits the received electrophysiological signals to the data analysis server;

step S21, the data analysis server analyzes and processes the electrophysiological signals and feeds back the analyzed and processed results to the remote monitoring server; and

step S22, the remote monitoring server sends the result to the doctor terminal and displays the result through the doctor terminal;

the method is characterized in that the electrophysiological signal is a surface electromyogram signal of a Parkinson patient, and in step S21, the method for analyzing and processing the electrophysiological signal by the data analysis server comprises the following steps:

wherein x is original surface electromyography data, x _i For each acquisition point of the original data, the SEMG is surface electromyogram data after normalization; and

step S213, calculating an overall condition score, which follows the formula:

wherein, RMS is normalized effective value of surface electromyogram signal, the calculation method is:

the MDF is the intermediate frequency of the surface electromyogram signal, and after the power spectrum estimation of the signal is calculated by adopting a numerical calculation method, the frequency which divides the power spectrum area into two is found and is the intermediate frequency;

kur is the kurtosis coefficient, which is calculated as:

samp is sample entropy;

REC is a data regression rate index in recursive quantitative analysis;

ω ₁ ～ω ₆ as a weight sequence for each patient.

2. The method of claim 1, wherein the patient external controller further comprises an electrophysiological signal determination module, and the step S15 of sending the acquired electrophysiological signals to the remote monitoring server comprises the steps of:

step S151, simply analyzing the collected electrophysiological signals through the electrophysiological signal discrimination module, and classifying according to different risk levels;

step S152, when the risk level is lower, data is sent to the patient client side and then sent to the remote monitoring server through the patient client side; and

and step S153, when the risk level is higher, directly sending the data to the remote monitoring server.

3. The method of claim 1, wherein in step S15, if the signal acquisition module cannot acquire the electrophysiological signals of the patient through the electrophysiological signal sensor, a report is sent to the remote monitoring server.

4. The method of claim 1, wherein in step S22, the remote monitoring server presents the analysis result of the electrophysiological signal in the form of a web page to an audio/video component of the physician terminal.

5. The method of claim 1, wherein the results are presented in an advanced monitoring module of the remote monitoring website.

6. The method of claim 1, wherein in step S22, the remote monitoring server automatically selects common parameters in the stored patient medical record information according to the analysis result of the data analysis server, and sends a command for adjusting or closing parameters to the implantable medical device.

7. The method of claim 1, wherein the analyzing of the electrophysiological signal by the data analysis server comprises utilizing linear analysis, nonlinear analysis, and machine learning.

8. The method of claim 1, wherein in step S22, the remote monitoring server stores the analysis result of the electrophysiological signal in a monitoring parameter and patient status query/storage module.