A follow-up system for implantable medical devices

Abstract

The present invention discloses a follow-up system for implantable medical devices, belonging to the technical field of medical devices. A patient client receives device parameter data and physiological parameter data collected by an implantable medical device, and transmits the data to a server. The server extracts parameter characteristic values ​​after preprocessing the received device parameter data and physiological parameter data, and obtains working parameter program-controlled suggestions based on the physiological parameter characteristic values ​​and / or device parameter characteristic value evaluations. The working parameter program-controlled suggestions include physiological parameter program-controlled suggestions and device parameter program-controlled suggestions. After a doctor client obtains the working parameter program-controlled suggestions from the server, the working parameter program-controlled values ​​of the implantable medical device are updated through a program controller according to the working parameter program-controlled suggestions. The program-controlled suggested values ​​of various working parameters are remotely deduced based on historical physiological data and the working parameters of the device, and the implantable medical device is managed and maintained according to the program-controlled suggested values, thereby improving the efficiency and quality of follow-up.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a follow-up system for implantable medical devices. Background Art

[0002] With the development of science and technology and medical technology, implantable medical devices work longer and longer in the human body. For example, implantable cardiac pacemakers and defibrillators can generally work in the human body for 15 to 20 years after being implanted. In order to monitor the working status of these devices and the physiological status of patients with implantable medical devices, implantable medical devices and patients with implantable medical devices must be followed up regularly. Therefore, patients need to go to the hospital for follow-up regularly. During the follow-up, doctors generally read the working parameters of the device and the patient's own physiological parameters through a programmable instrument to determine whether the working status of the device and the patient's physiological status are normal. At the same time, doctors adjust the working parameters of the implantable medical device as needed to achieve the best treatment effect for patients.

[0003] Due to the lack of medical resources, implant treatment is usually performed by experienced attending physicians in hospitals, while postoperative follow-up is usually performed by physician assistants or follow-up physicians. Physician assistants and follow-up physicians often need to seek help from professional physicians to complete follow-up visits due to their lack of rich programming experience and professional technical guidance, which brings great inconvenience to follow-up visits. At the same time, in some remote areas or cities, due to the backward level of medical technology, patients cannot receive implant treatment and postoperative follow-up in local hospitals and need to go to developed cities for treatment and follow-up.

[0004] Patients with heart implants need to go to the hospital for follow-up every three to six months to monitor and adjust the main working parameters of the implanted medical device, such as pacing frequency, pacing threshold and sensing sensitivity. However, as the number of patients with heart implants increases, the burden of follow-up visits to hospitals is also increasing, especially in large hospitals in developed cities.

[0005] At present, in order to ease the follow-up burden of doctors and patients, major implantable medical device manufacturers have also launched corresponding products, such as remote follow-up, remote monitoring and remote assistance systems. These systems have solved the follow-up burden of doctors and patients to a certain extent. For example, patients in remote areas do not need to go to developed cities for follow-up. Follow-up doctors in local hospitals can request remote follow-up experts and doctors to complete the follow-up through remote assistance. However, they all rely on experienced follow-up doctors and experts for follow-up, and they need to make appointments with remote experts and doctors in advance, which has certain limitations. Summary of the invention

[0006] In view of the above, an object of the present invention is to provide a follow-up system for an implantable medical device, which remotely calculates the programmed recommended values ​​of various working parameters based on the collected historical physiological data and the working parameters of the device, manages and maintains the implantable medical device according to the programmed recommended values, and improves the efficiency and quality of follow-up.

[0007] In order to achieve the above-mentioned invention object, the present invention provides the following technical solutions:

[0008] A follow-up system for an implantable medical device, comprising a patient client, a doctor client and a server, wherein the patient client and the doctor client are both connected to the server in communication; the patient client is connected to the implantable medical device in communication, receives device parameter data collected by the implantable medical device and the patient's physiological parameter data, and transmits the data to the server;

[0009] The server extracts parameter characteristic values ​​after preprocessing the received device parameter data and physiological parameter data, and obtains working parameter program control suggestions based on the physiological parameter characteristic values ​​and / or the device parameter characteristic values, wherein the working parameter program control suggestions include physiological parameter program control suggestions and device parameter program control suggestions;

[0010] After the doctor client obtains the working parameter programming suggestion from the server, it updates the working parameter programming value of the implantable medical device through the programming instrument according to the working parameter programming suggestion.

[0011] Compared with the prior art, the present invention has the following beneficial effects:

[0012] The implantable medical device follow-up system provided by the present invention collects and stores the working parameter data of the implantable cardiac device and the physiological parameter data of the patient, summarizes and analyzes the historical parameter data, extracts the characteristic values ​​of each parameter, and then evaluates the reasonable program control recommended values ​​of each parameter according to the parameter characteristic values ​​and the current program control values. The follow-up doctor can remotely obtain the program control recommended values ​​of each parameter through the doctor client during the follow-up, and program the implantable cardiac device according to the selection. This can assist the follow-up doctor in postoperative follow-up, making the follow-up programming simpler and more instructive, while reducing the follow-up time of doctors and patients to improve the follow-up efficiency and quality. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0014] Figure 1 is a schematic structural diagram of a follow-up system for an implantable medical device provided by an embodiment of the present invention;

[0015] Figure 2 It is a schematic diagram of functional modules of a patient client in a follow-up system provided by an embodiment of the present invention;

[0016] Figure 3 Schematic diagram of functional modules of a server in a follow-up system provided by an embodiment of the present invention;

[0017] Figure 4 It is a schematic diagram of the functional modules of the doctor client in the follow-up system provided by an embodiment of the present invention. DETAILED DESCRIPTION

[0018] To make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific implementation methods described herein are only used to explain the present invention and do not limit the scope of protection of the present invention.

[0019] In order to solve the problem that most follow-up doctors have difficulty in postoperative follow-up of patients with cardiac implant devices due to lack of professional follow-up knowledge and rich follow-up experience, an embodiment of the present invention provides a follow-up system for implantable medical devices, which collects the working parameters of the device and the physiological parameters of the patient through the implantable cardiac device, and transmits the collected data to the patient terminal at regular intervals every day, and the patient terminal transmits the data to the server. The server stores the data received every day and summarizes and analyzes the stored data over a period of time, extracts the characteristic values ​​of each parameter, and evaluates the recommended program values ​​of each parameter based on the characteristic values ​​and the current program values, and feeds back to the follow-up doctor. In this way, the efficiency and quality of follow-up of patients using implantable medical devices are improved.

[0020] Figure 1 The following is a schematic diagram of the structure of the follow-up system for implantable medical devices provided by an embodiment of the present invention. Figure 1 As shown, the follow-up system for implantable medical devices provided in the embodiment includes an implantable medical device 100, a patient client 200, a server 300, a doctor client 400 and a programmer 500, wherein the dotted line frame indicates that the components are not visible, and the solid line frame indicates that the components are visible.

[0021] The implantable medical device 100 is implanted in the patient's body to assist the patient's normal physiological needs when the patient needs it. The implantable medical device 100 can be a medical device such as a pacemaker generator for heart rate pacing. These implantable medical devices can collect various device parameter data when the device is working in real time, such as battery voltage, internal resistance, electrode impedance, pacing voltage, etc., and can also collect various physiological parameter data of the patient in real time, such as heart rate, cardiac events, atrioventricular conduction interval, atrioventricular block events, sensory sensitivity, pacing threshold, premature beat events, atrial high frequency, ventricular high frequency, intracavitary electrocardiogram, motion information, etc. The implantable medical device 100 also has a Bluetooth communication function. The Bluetooth communication function is turned on at regular intervals every day, and a Bluetooth communication connection is actively established with the patient client 200 carried by the patient and the collected data is transmitted to the patient client 200.

[0022] The patient client 200 is a portable terminal set up at the patient's end. It is generally a universal or customized mobile phone with low-power Bluetooth, 5G or WI-FI function. It can communicate with the implantable medical device 100 and the server 300 at the same time, receive the device parameter data and physiological parameter data uploaded by the implantable medical device 100, store them, and then upload them to the server 300. Before uploading the data, data verification and confirmation are required. Only after confirmation that there is no problem will it be uploaded to the server 300.

[0023] Figure 2 Schematic diagram of the functional modules of the patient client 200 provided in the embodiment. Figure 2 As shown, the patient client 200 provided in the embodiment includes a Bluetooth communication module 201 , a first network communication module 202 , a first authorization authentication module 203 and a first local storage module 204 .

[0024] The Bluetooth communication module 201 is used to establish a communication channel with the implantable medical device, broadcast the implantable medical device, and receive device parameter data and patient physiological parameter data uploaded by the implantable medical device.

[0025] The first network communication module 202 is used to establish a communication channel with the server 300, and upload the received device parameter data and the patient's physiological parameter data to the server 300. Among them, the first network communication module 202 adopts a public network interface, and can use cellular networks such as 4G, 5G, and local area networks such as WI-FI to transmit data with the server 300.

[0026] The first authorization authentication module 203 is used to verify user information and implantable medical device identification. The user information includes the patient's username and password, which constrain the user correspondence between the patient client 200 and the server 300. When the username and password correspondence is verified to be correct, the patient client 200 and the server 300 will transmit the collected data; the implantable medical device identification is generally the device serial number, which constrains the binding relationship between the patient client 200 and the implantable medical device 100. When it is verified that the implantable medical device 100 in the patient's body is bound to the current user client 200, the patient client 200 and the implantable medical device 100 will transmit the collected data.

[0027] The first local storage module 204 is used to store the received device parameter data, the patient's physiological parameter data, and data transmission records. The first local storage module 204 is generally used as a cache storage module to store some historical device parameter data, the patient's physiological parameter data, and data transmission records within a set period closest to the current one. For example, the set period can be 1 week or 2 weeks.

[0028] In the follow-up system, the patient client 200 and the implantable medical device 100 and the server 300 all transmit data in an encrypted manner. The patient client 200 and the server 300 also generally transmit data in a regular periodic manner. Generally, 7 days is selected as a cycle, and the patient client 200 regularly uploads 7 days of collected data to the server 300 every week.

[0029] After the implantable medical device 100 establishes a Bluetooth connection with the patient client 200 through the Bluetooth communication module 201, the implantable medical device 100 first needs to send its own device identification to the patient client 200. The patient client 200 verifies the device identification of the implantable medical device 100 through the first authorization authentication module 203, and receives the collected data uploaded by the implantable medical device 100 after the verification. Before verifying the device identification of the implantable medical device 100, the patient client 200 needs to request the device information of the current user from the server 300. The device information contains the device identification, and the implantable medical device 100 is verified based on the device identification.

[0030] The server 300 serves as a background processing and management platform, and has a public network interface. It establishes communication with the patient client 200 and the doctor client 400 through the cellular network and the local area network at the same time. After receiving the equipment parameter data and physiological parameter data uploaded by the patient client 200, it extracts the characteristic values ​​of each parameter in combination with the data received at that time and the historical data stored in the past period of time, and obtains the working parameter programming suggestions based on the evaluation of the characteristic values ​​of each parameter and the current parameter programming values, and saves them for download by the doctor client 400.

[0031] Figure 3 Schematic diagram of the functional modules of the server in the follow-up system provided by the embodiment of the present invention. Figure 3 As shown, the server 300 provided in the embodiment includes a second network communication module 301 , a data processing module 302 , a second authorization authentication module 303 , a database module 304 , a data evaluation module 305 and a log recording module 306 .

[0032] The second network communication module 301 is used to establish a communication channel with the patient client 200 and the doctor client 400, receive the device parameter data and the patient's physiological parameter data uploaded by the patient client 200, and send the working parameter program control suggestion to the doctor client 400. Among them, the second network communication module 301 also uses a public network interface, and can use cellular networks such as 4G, 5G, and local area networks such as WI-FI to transmit data with the patient client 200 and the doctor client 400.

[0033] The data processing module 302 is used for data analysis, assembly and storage in the database module 304. After the data is packaged, it is transmitted to the server 300 along with the communication signal. After the packaged data packet is obtained, it is generally processed by data analysis and data classification and reorganization for classification and storage.

[0034] The second authorization authentication module 303 is used for user management and data access permission management. User management is used to verify the user's username and password, which constrains the user correspondence between the patient client 200 and the server 300. When the username and password correspondence is verified to be correct, the collected data will be transmitted between the patient client 200 and the server 300; data access permission management is used to manage the user's permission to read and write data, such as the parameter program control recommended value only allows the user to read, but not write.

[0035] The database module 304 is used to store user information, implantable medical device information, received device parameter data and patient physiological parameter data, and working parameter program control suggestions. That is, the collected data and calculated data of the entire follow-up system must be stored in the database module.

[0036] The data evaluation module 305 is used to extract parameter characteristic values ​​based on the device parameter data and the physiological parameter data, and then analyze the physiological parameter characteristic values ​​and / or the device parameter characteristic values ​​to obtain working parameter program control suggestions, wherein the working parameter program control suggestions include physiological parameter program control suggestions and device parameter program control suggestions.

[0037] Among them, the parameter feature can be a value that is reasonably stable under normal working conditions predicted or derived based on the actual working value of the implantable medical device 100 in the past period of time. When evaluating the physiological parameter programming suggestion, the physiological parameter programming suggestion can be obtained based on the characteristic values ​​of each physiological parameter and the current parameter programming value. For example, for cardiac pacing treatment, the pacing frequency programming suggestion can be evaluated based on cardiac events, heart rate ranges, and current pacing frequency programming values. Of course, the physiological parameter programming suggestion can also be evaluated based on the characteristic values ​​of each physiological parameter, the characteristic values ​​of each device parameter, and the current parameter programming value. For example, for cardiac pacing pulse treatment, the pacing threshold programming suggestion can be evaluated based on the pacing voltage value and cardiac capture status of the cardiac device and the current pacing threshold programming value.

[0038] When evaluating the device parameter program control suggestion, the device parameter program control suggestion can be obtained based on the characteristic values ​​of each device parameter and the current parameter program control value. Of course, the device parameter program control suggestion can also be obtained based on the characteristic values ​​of each physiological parameter, the characteristic values ​​of each device parameter and the current parameter program control value.

[0039] In a possible implementation, in the data evaluation module 305, parameter characteristic values ​​are extracted by analyzing the distribution status of device parameter data and physiological parameter data; during implementation, a machine learning-based method can be used to analyze the distribution status of device parameter data and physiological parameter data, and then extract parameter characteristic values, wherein the machine learning can be various deep learning methods composed of neural networks and fully connected networks, and different deep learning models are used for parameters of different items; of course, traditional feature extraction methods can also be used to extract parameter characteristic values, such as wavelet transform.

[0040] Based on the parameter characteristic value, the parameter setting standard in the industry is used to derive the working parameter program control recommended value, and the distribution of the working parameter characteristic value and the parameter program control recommended value constitute the working parameter program control recommended value. The physiological parameter program control recommended values ​​given for different working parameters will also be different.

[0041] The log recording module 306 is used to store user access records and data transmission records. Generally, the log recording module 306 is used to store some historical user access records and some historical data transmission records within the set period closest to the current one. For example, if the set period is 7 days, the user access record data transmission records within 7 days are recorded.

[0042] The doctor client 400 can be a PC client or mobile client with 5G or WI-FI function set at the doctor's end. The working parameter program control suggestion obtained by the evaluation of the server 300 is downloaded by establishing communication with the server 300, and the working parameter program control value of the implantable medical device is updated through the program controller according to the working parameter program control suggestion.

[0043] Figure 4 Schematic diagram of the functional modules of the doctor client in the follow-up system provided by the embodiment of the present invention. Figure 4 As shown, the doctor client 400 provided in the embodiment includes a third communication module 401 , a programmer display module 402 , a third authorization authentication module 403 and a second local storage module 404 .

[0044] The third communication module 401 is used to establish a communication channel with the server, and obtain the working parameter program control suggestion from the server based on the sent data request. In the embodiment, the doctor client 400 and the server 300 transmit data in an encrypted transmission manner.

[0045] The programmer display module 402 is used to display the acquired working parameter programming suggestions. This module provides a friendly data viewing interface for doctors, through which the working parameter programming suggestions acquired from the server 300 are displayed.

[0046] The third authorization authentication module 403 is used to verify user information. The user information includes the doctor's username and password, which constrains the user correspondence between the doctor client 400 and the server 300. When the username and password correspond correctly, the doctor client 400 and the server 300 will transmit the collected data.

[0047] The second local storage module 404 is used to store the program-controlled suggestions for working parameters and the data request records. The second local storage module 404 is generally used as a cache storage module to store some program-controlled suggestions for working parameters and some data request records within the set period closest to the current one. For example, the set period can be 7 days, that is, the historical program-controlled suggestions for working parameters and the historical data request records of 7 days are stored.

[0048] The doctor client 400 can also be integrated into the programmer 500, and the doctor can obtain working parameter programming suggestions directly from the server 300 through the programmer.

[0049] The programmer 500 is an external device used to manage the implantable medical device 100 . The doctor can reset the program value of the working parameter of the implantable medical device 100 through the programmer 500 .

[0050] In the embodiment, the follow-up process of the follow-up system using the above implantable medical device is as follows:

[0051] 1. Preparation of the doctor's client device before follow-up. Turn on the network function of the doctor's client device to ensure normal network communication; run the doctor's client software, enter the doctor's user name and password, and ensure that the doctor user logs in successfully.

[0052] 2. Preparation of the programmer. The doctor uses the programmer to establish a session connection with the implanted medical device in the patient's body and read the working parameters and data of the implanted medical device.

[0053] 3. Doctors obtain and view working parameter program control suggestions through the doctor client.

[0054] 4. The doctor uses a programmer to program parameters into the implantable medical device in the patient's body as needed.

[0055] The application of the follow-up system of the above-mentioned implantable medical device in cardiac pacing is described in detail below.

[0056] When an implantable medical device is used for cardiac pacing, the implantable medical device is a pacemaker. The pacing frequency refers to the patient's lowest heart rate when the pacemaker is in normal working condition (except for pacemakers with pacing hysteresis function). When the patient's own heart rate is higher than the pacing frequency, the pacemaker will not send pacing pulses. Only when the patient's own heart rate is lower than the pacing frequency will the pacemaker send pacing pulses. For patients whose own heart rate is intermittent, the pacing frequency should be programmed according to the patient's autonomous heart rate, so that the patient's blood supply function can be guaranteed by issuing pulses when the patient's own heart rate is insufficient, and the patient's own heart rate can be encouraged by not issuing pulses when the patient's own heart rate is normal. Therefore, it is particularly important to guide the programming of pacing frequency parameters by tracking and confirming the patient's autonomous heart rate.

[0057] The embodiment provides a method for extracting characteristic values ​​of the pacing frequency of a pacemaker in single-chamber mode and a method for evaluating program control recommendations. When an implantable medical device is used for cardiac pacing, the collected physiological parameter data is cardiac event data. After the server determines the characteristic value of the cardiac event based on the distribution state of the cardiac event data in the heart rate range, it determines the program control recommendation of the pacing frequency based on the characteristic value of the cardiac event and the preset upper and lower limits of the pacing ratio.

[0058] Specifically, the pacemaker counts and records the patient's cardiac event data every day, and transmits the cardiac event data within the past 24 hours to the server at a fixed time every day. The server extracts the characteristic value of the cardiac event data within the past period of time, and the time period is generally the same as the patient's follow-up period. After the server 13 successfully extracts the characteristic value of the cardiac event, it evaluates the patient's pacing frequency programming value based on the characteristic value of the cardiac event.

[0059] In the single-chamber VVI mode, the cardiac events counted by the pacemaker include ventricular pacing events (VP), ventricular sensing events (VS) and ventricular sensing events during the refractory period (VR). In order to save storage space and reduce data transmission, the pacemaker only counts the total number of each cardiac event in different heart rate intervals. In the embodiment, the heart rate range is divided into multiple heart rate intervals according to a fixed step size. When collecting physiological parameter data, the total number of VP, VS and VR events in each heart rate interval is recorded separately, so the total statistical data has 3*16 dimensional data. In the embodiment, the pacing frequency value range is generally 30-175ppm, with an interval of 5ppm.

[0060] The cardiac events used in feature value extraction are valid cardiac events, which refer to cardiac events that occur under the patient's normal autonomous heart rate and pacing heart rate. VR is a ventricular sensing event within the refractory period, which does not affect the patient's heart rate and is not considered a valid cardiac event. VP events will only appear in the heart rate grouping interval corresponding to the pacing frequency programming value, and VS events will only appear in the heart rate grouping interval corresponding to a value higher than the pacing frequency programming value. VS events within the heart rate group that exceed a certain proportion of the pacing frequency programming value are also not considered valid cardiac events. This proportion is defined as the heart rate floating value. In this case, although it is the patient's autonomous heart rate, the heart rate at this time is not considered to be the patient's normal heart rate.

[0061] Based on this, the characteristic values ​​of cardiac events are determined according to the distribution state of cardiac event data in the heart rate interval, including:

[0062] Determine the starting heart rate interval and the ending heart rate interval of the effective cardiac event according to the current pacing frequency and the preset heart rate floating ratio value, construct the effective cardiac event period according to the starting heart rate interval and the ending heart rate interval, and take the ventricular pacing events and ventricular sensing events within the effective cardiac event period as the effective cardiac event;

[0063] The proportion of each type of valid cardiac event in the valid cardiac events during the valid cardiac event period is calculated as the cardiac event characteristic value.

[0064] In one possible implementation, the process of constructing a valid cardiac event period is:

[0065] The heart rate range is divided into multiple heart rate intervals according to a fixed step size. For example, when the heart rate range is divided into 16 heart rate intervals, they are: <=40, 40-50, 50-60, 60-70, 70-80, 80-90, 90-100, 100-110, 110-120, 120-130, 130-140, 150-160, 160-170, 170-180, >180.

[0066] The heart rate interval where the current pacing frequency LR is located is the starting heart rate interval SHRD of the effective cardiac event, and the heart rate interval where the floating pacing frequency is located determined according to the current pacing frequency LR and the heart rate floating ratio value HF is the ending heart rate interval EHRD of the effective cardiac event; in the embodiment, the ending heart rate interval EHRD can be determined according to the formula LR*(1+HP).

[0067] The effective cardiac event period is composed of the starting heart rate interval SHRD of the effective cardiac event and the ending heart rate interval EHRD of the effective cardiac event, together with all the heart rate intervals experienced in between. All ventricular pacing events VP and ventricular sensing events VS in the effective cardiac event period are effective cardiac events.

[0068] On the basis of determining the effective cardiac events and the effective cardiac event period, the proportion of each type of effective cardiac events in the effective cardiac event period is calculated as the cardiac event characteristic value, including:

[0069] The proportion of ventricular pacing events in the effective cardiac event period to all effective cardiac events is taken as the first characteristic value, that is, the first characteristic value T = N VP / (N VP +N VS ), N VP N is the number of all ventricular pacing events VP during the effective cardiac event period. VS is the number of all ventricular sensing events VS;

[0070] The proportion of ventricular sensing events in each heart rate interval in the effective cardiac event period to all ventricular sensing events in the effective cardiac event period is taken as the second eigenvalue corresponding to each heart rate interval, that is, the second eigenvalue corresponding to the i-th heart rate interval is the number of ventricular sensing events VS in the i-th heart rate interval. When the effective cardiac event period includes M heart rate intervals, there are M second eigenvalues.

[0071] The calculated first characteristic value and second characteristic value are used as the basis for evaluating the pacing frequency programming recommendation data. Based on this, the pacing frequency programming recommendation is determined according to the cardiac event characteristic value and the preset pacing ratio upper and lower limits, including:

[0072] Compare the first characteristic value T with the pacing ratio lower limit value LP. When the first characteristic value T is greater than the pacing ratio lower limit value LP, keep the current pacing frequency programming value unchanged. In the embodiment, when the first characteristic value T is greater than the pacing ratio lower limit value LP, it can be considered that the patient's own heart rate is low, and the patient's heart rate is usually mainly based on pacing. It is recommended that the pacing frequency maintain the current pacing frequency programming value LR. The pacing ratio lower limit value LP can be programmed by the doctor to the pacemaker through the programming instrument, and the pacemaker transmits LP to the server. The doctor can also program it to the server through the doctor client, such as setting it to 80%.

[0073] When the first eigenvalue is less than the upper limit of the pacing ratio, the heart rate interval corresponding to the maximum second eigenvalue is used as the reference heart rate interval, and a heart rate value within the reference heart rate interval is taken as the pacing frequency programming value. When the first eigenvalue T is less than the upper limit of the pacing ratio HP, the patient's heart rate is usually mainly autonomous, and it is recommended to increase the pacing frequency. The upper limit of the pacing ratio HP can be programmed by the doctor to the pacemaker through the program controller, and the pacemaker is prepared to transmit LP to the server. The doctor can also program it to the server through the doctor client, such as setting it to 20%.

[0074] How to adjust the pacing frequency and how many levels to increase it, refer to the second characteristic value, and take the second characteristic value F1 to the second characteristic value F M The heart rate interval corresponding to the maximum value is the dominant heart rate of the patient's autonomous heart rate, because the heart rate in this heart rate interval accounts for the largest proportion, which means that the patient's heart rate is mainly distributed in this interval when there is a spontaneous heart rate, and it also means that this heart rate interval is the baseline heart rate of the patient during normal activities. The pacing frequency should be adjusted to the corresponding heart rate range, because even if the patient's own heart rate is not there, the patient can reach a heart rate equivalent to the autonomous heart rate through the pacing frequency. When determining the pacing frequency programming value specifically based on the reference heart rate interval, any heart rate within the reference heart rate interval can be selected as the pacing frequency programming value, and preferably the lower limit of the reference heart rate interval can be selected as the pacing frequency programming value. For example, assuming that the current pacing frequency is 70ppm and the determined reference heart rate interval is 80-90ppm, 80ppm can be selected as the pacing frequency programming value.

[0075] When the first characteristic value T is greater than the upper limit value HP of the pacing ratio and less than the lower limit value LP of the pacing ratio, this situation is used as a pacing frequency programming recommendation. When T is greater than HP and less than LP, it means that the patient's pacing heart rate is not much different from his own heart rate. In this case, the patient's pacing frequency ratio HF and the distribution of his own heart rate interval are recommended to the doctor, who will adjust the pacing frequency programming value according to the patient's actual situation.

[0076] In the single-chamber AAI mode, the cardiac events counted by the pacemaker include atrial pacing events (AP), atrial sensed events (AS) and atrial sensed events during the refractory period (AR). In this AAI mode, the process of programming the cardiac pacing frequency based on atrial pacing events by the follow-up system of the implantable medical device is similar to that in the VVI mode. It can be understood that AP, AS and AR are directly replaced by VP, VS and VR respectively, and the same method of extracting cardiac event characteristic values ​​and determining the pacing frequency programming recommendation based on the cardiac event characteristic values ​​and the preset upper and lower limits of the pacing ratio are used. The specific implementation process and effects are detailed in the process of programming the cardiac pacing frequency based on atrial pacing events by the follow-up system of the implantable medical device in the VVI mode, which will not be repeated here.

[0077] The specific implementation methods described above provide a detailed description of the technical solutions and beneficial effects of the present invention. It should be understood that the above is only the most preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, supplements and equivalent substitutions made within the scope of the principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A follow-up system for an implantable medical device, comprising a patient client, a doctor client and a server, wherein the patient client and the doctor client are both connected to the server in communication; the patient client is connected to the implantable medical device in communication, characterized in that: The patient client receives device parameter data and patient physiological parameter data collected by the implantable medical device and transmits the data to the server, wherein the implantable medical device is used for cardiac pacing and the collected physiological parameter data is cardiac event data; The server extracts parameter characteristic values ​​after preprocessing the received device parameter data and physiological parameter data, including: for cardiac pacing, determining cardiac event characteristic values ​​according to the distribution state of cardiac event data in the heart rate interval, specifically including: in the single-chamber VVI mode, the cardiac events include ventricular pacing events, ventricular sensing events and ventricular sensing events in the refractory period; determining the starting heart rate interval and the ending heart rate interval of the effective cardiac event according to the current pacing frequency and the preset heart rate floating ratio value, constructing the effective cardiac event period according to the starting heart rate interval and the ending heart rate interval, and taking the ventricular pacing events and ventricular sensing events in the effective cardiac event period as the effective cardiac events; calculating the proportion of each type of effective cardiac events in the effective cardiac events in the effective cardiac event period as the cardiac event characteristic value, specifically taking the proportion of ventricular pacing events in the effective cardiac event period to all effective cardiac events as the first characteristic value; taking the proportion of ventricular sensing events in each heart rate interval in the effective cardiac event period to all ventricular sensing events in the effective cardiac event period as the second characteristic value corresponding to each heart rate interval; The server is also used to evaluate and obtain working parameter program control suggestions based on physiological parameter characteristic values ​​and / or device parameter characteristic values, and the working parameter program control suggestions include physiological parameter program control suggestions and device parameter program control suggestions, including: for cardiac pacing, determining pacing frequency program control suggestions based on cardiac event characteristic values ​​and preset pacing ratio upper and lower limits, specifically including: comparing the first characteristic value with the pacing ratio lower limit, when the first characteristic value is greater than the pacing ratio lower limit, keeping the current pacing frequency program control value unchanged; when the first characteristic value is less than the pacing ratio upper limit, taking the heart rate interval corresponding to the maximum second characteristic value as the reference heart rate interval, and taking a heart rate value within the reference heart rate interval as the pacing frequency program control value; when the first characteristic value is greater than the pacing ratio upper limit and less than the pacing ratio lower limit, taking this situation as the pacing frequency program control suggestion; wherein the pacing ratio lower limit is set to 80%, and the pacing ratio upper limit is set to 20%; After the doctor client obtains the working parameter programming suggestion from the server, it updates the working parameter programming value of the implantable medical device through the programming instrument according to the working parameter programming suggestion.

2. The follow-up system for an implantable medical device according to claim 1, characterized in that: The patient client includes a Bluetooth communication module, a first network communication module, a first authorization authentication module and a first local storage module. The Bluetooth communication module is used to establish a communication channel with the implantable medical device, broadcast the implantable medical device and receive device parameter data uploaded by the implantable medical device and the patient's physiological parameter data; The first network communication module is used to establish a communication channel with the server and upload the received device parameter data and the patient's physiological parameter data to the server; The first authorization authentication module is used to verify user information and implantable medical device identification; The first local storage module is used to store received device parameter data, patient physiological parameter data, and data transmission records.

3. The follow-up system for an implantable medical device according to claim 1, characterized in that: The server includes a second network communication module, a second authorization authentication module, a data processing module, a database module, a data evaluation module and a log recording module; The second network communication module is used to establish a communication channel with the patient client and the doctor client, receive the device parameter data and the patient's physiological parameter data uploaded by the patient client, and send the working parameter program control suggestion to the doctor client; The second authorization and authentication module is used for user management and data access permission management; The data processing module is used for analyzing, assembling and storing data in a database module; The database module is used to store user information, implantable medical device information, received device parameter data and patient physiological parameter data, and working parameter program control suggestions; The data evaluation module is used to extract parameter characteristic values ​​based on the device parameter data and the physiological parameter data, and then analyze the physiological parameter characteristic values ​​and / or the device parameter characteristic values ​​to obtain working parameter program control suggestions; The log recording module is used to store user access records and data transmission records.

4. The follow-up system for an implantable medical device according to claim 3, characterized in that: In the data evaluation module, parameter characteristic values ​​are extracted by analyzing the distribution states of the device parameter data and the physiological parameter data; Based on the parameter characteristic value, the working parameter program control recommended value is derived by using the parameter setting standard in the industry. The working parameter program control recommended value and the distribution of the parameter characteristic value constitute the working parameter program control recommendation.

5. The follow-up system for an implantable medical device according to claim 3, characterized in that: In the data evaluation module, a machine learning-based method is used to analyze the distribution status of device parameter data and physiological parameter data, and then parameter characteristic values ​​are extracted.

6. The follow-up system for an implantable medical device according to claim 1, wherein: The doctor client includes a third communication module, a program controller display module, a third authorization authentication module and a second local storage module. The third communication module is used to establish a communication channel with the server and obtain a physiological parameter program-controlled suggestion from the server based on the sent data request; The program controller display module is used to display the acquired working parameter program control suggestions; The third authorization and authentication module is used to verify user information; The second local storage module is used to store working parameter program control suggestions and data request records.

7. The follow-up system for an implantable medical device according to claim 1, characterized in that: The patient client and the implantable medical device and the server all transmit data in an encrypted manner; the doctor client and the server transmit data in an encrypted manner.

8. The follow-up system for an implantable medical device according to claim 1, wherein: The process of constructing a valid cardiac event period is: Divide the heart rate range into multiple heart rate zones according to fixed step lengths; The heart rate interval where the current pacing frequency is located is used as the starting heart rate interval of the effective cardiac event, and the heart rate interval where the floating pacing frequency is located, which is determined according to the current pacing frequency and the heart rate floating ratio value, is used as the ending heart rate interval of the effective cardiac event; The effective cardiac event period is composed of the starting heart rate interval of the effective cardiac event and the ending heart rate interval of the effective cardiac event, together with all the heart rate intervals experienced in between.

9. The follow-up system for an implantable medical device according to any one of claims 1 to 8, characterized in that: In the single-chamber AAI mode, the cardiac events counted by the pacemaker include atrial pacing events, atrial sensing events, and atrial sensing events during the refractory period; In the single-chamber AAI mode, the follow-up system of the implantable medical device performs a programming process of the cardiac pacing frequency based on atrial pacing events, which is similar to the single-chamber VVI mode, that is, ventricular pacing events, ventricular sensing events, and ventricular sensing events during the refractory period replace atrial pacing events, respectively. After atrial sensing events and atrial sensing events during the refractory period, the same cardiac event feature value extraction method and the method of determining the pacing frequency programming recommendation based on the cardiac event feature values ​​and the preset upper and lower limits of the pacing ratio are used.

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