A warning system and method for implantable pulse generator

Abstract

The present application relates to the field of medical device technology, and in particular to an early warning system and method for an implantable pulse generator. The system includes an intracavitary electrocardiogram (ICEG) data acquisition module, a Bluetooth module, an intracavitary electrocardiogram (ICEG) data processing module, a signal indication module, and a pulse generator. The method first obtains a programmable parameter combination in the pulse generator, and pre-processes the obtained raw ICEG data to obtain theoretical results of the ICEG data to be used and its status; then determines the capture accuracy and loss of capture accuracy of the preset parameter combination for the ICEG data to be used; and finally determines the early warning level of the programmable parameter combination. The system and method adopt a management method of actively monitoring the pacing threshold, which can improve the reliability of the implantable pulse generator, and automatically optimize the programmable parameter combination according to its early warning level to ensure the effectiveness of the pacing pulse. The system and method only remind the user to go to the clinic for follow-up when necessary, reducing on-site follow-up work.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to an early warning system and method for an implantable pulse generator. Background Art

[0002] The most basic function of an implantable pulse generator is to stimulate the myocardium by issuing atrial or ventricular pacing pulses to avoid cardiac arrest. However, as time goes by, the user's atrial and ventricular pacing thresholds will change to a certain extent. Therefore, it is necessary to continuously optimize the pacing output amplitude of the pulse generator to ensure the effectiveness of the pacing pulse. In order to achieve this goal, early pulse generators had to require users to visit the clinic regularly for follow-up and optimize the pacing pulse amplitude when necessary. However, this regular follow-up method has the following disadvantages: First, it cannot be discovered in time that the pacing pulse cannot effectively capture the myocardium. Therefore, the optimization of the pacing output amplitude often cannot be completed in the first time; second, after follow-up, the pacing pulse amplitude of most users does not need to be optimized. Therefore, it wastes limited medical resources and the user's time and follow-up costs. For example Figure 1 As shown in the figure, in the four regular follow-ups, the first and third follow-ups confirmed that the pacing pulse was effective, so there was no need to optimize the pacing pulse amplitude; while the second and fourth follow-ups confirmed that the pacing pulse was ineffective, so the pacing pulse amplitude needed to be optimized. However, the optimization timing was not optimal, so long-term pacing ineffectiveness occurred in the time periods T1~T2 and T3~T4.

[0003] The automatic pacing threshold capture function with beat-by-beat detection can identify the capture and loss of capture status of each pacing pulse of the implantable pulse generator, and when loss of capture is detected, it will promptly start the pacing threshold search and automatically optimize the pacing pulse amplitude. Figure 2 As shown in the figure, at times T1, T2, and T3, pacing ineffectiveness occurs due to changes in the pacing threshold. The beat-by-beat detection function can immediately optimize the pacing pulse amplitude, thereby ensuring the effectiveness of the pacing pulse. Therefore, the beat-by-beat detection function largely overcomes the shortcomings of regular follow-up, enabling timely optimization of the pacing pulse amplitude while saving medical resources and follow-up costs.

[0004] However, the automatic pacing threshold capture function is established based on intracavitary electrocardiogram data. Therefore, when the intracavitary electrocardiogram data changes, the reliability of the automatic pacing threshold capture function may decrease. When the automatic pacing threshold capture function cannot correctly identify the loss of capture state of the pacing pulse, the effectiveness of the pacing pulse will not be guaranteed. Figure 3As shown in the figure, at T1 and T2, the automatic pacing threshold capture function identified the pacing pulse's loss of capture and correctly optimized the pacing pulse amplitude, thereby ensuring the effectiveness of the pacing pulse. However, at T3, due to changes in the intracavitary electrocardiogram data, the automatic pacing threshold capture function failed to successfully detect the loss of capture, resulting in the continued ineffectiveness of the pacing pulse after T3. Therefore, in theory, implantable pulse generators with automatic pacing threshold capture also require users to visit the clinic for regular follow-up to ensure the effectiveness of the pacing pulse. Summary of the Invention

[0005] The present application provides an early warning system and method for an implantable pulse generator to solve the problem that the traditional automatic pacing threshold capture function of the implantable pulse generator cannot successfully detect the loss of capture state when the intracavitary electrocardiogram data changes, thereby making the effectiveness of the pacing pulse unable to be guaranteed.

[0006] The technical solutions adopted by this application to solve the above technical problems are as follows:

[0007] In a first aspect, the present application provides an early warning system for an implantable pulse generator, comprising an intracavitary electrocardiogram (ICG) data acquisition module, a Bluetooth module, an intracavitary electrocardiogram (ICG) data processing module, a signal indication module, and a pulse generator;

[0008] The pulse generator is used to deliver pacing pulses and collect original intracavitary electrocardiogram data;

[0009] The intracavitary electrocardiogram data acquisition module is electrically connected to the pulse generator, and is used to read the program-controlled parameter combination in the pulse generator, and is also used to control the pulse generator to acquire the raw intracavitary electrocardiogram data, and pre-process the raw intracavitary electrocardiogram data to obtain the ready-to-use intracavitary electrocardiogram data;

[0010] The Bluetooth module is electrically connected to the intracavitary electrocardiogram data acquisition module and is used to communicate with the mobile terminal;

[0011] The intracavitary electrocardiogram data processing module is used to obtain the capture accuracy rate and the loss-capture accuracy rate of the to-be-used intracavitary electrocardiogram data by a preset parameter combination, and the programmable parameter combination is a set of parameter combinations in the preset parameter combination;

[0012] The information indication module is electrically connected to the intracavitary electrocardiogram data processing module, and is used to determine the warning level of the program-controlled parameter combination and display an operation indication corresponding to the warning level.

[0013] Furthermore, the intracavitary electrocardiogram data acquisition module includes: a timer, a first counter, a timer, an intracavitary electrocardiogram data preprocessing unit and a first storage unit;

[0014] The timer is electrically connected to the pulse generator and is used to trigger the intracavitary electrocardiogram data acquisition module to start working through the pulse generator at a first preset time;

[0015] The first counter is electrically connected to the pulse generator, and is used to record the number of groups of the collected original intracavitary electrocardiogram data, and trigger the Bluetooth module to work when the number of groups reaches a preset value;

[0016] The timer is electrically connected to the pulse generator, and is used to control the pulse generator to collect two sets of raw intracavitary electrocardiogram data after the first pulse and the second pulse in the preset collection area of the programmed parameter combination, and trigger the pulse generator to deliver a pacing pulse at a second preset time;

[0017] The intracavitary electrocardiogram data preprocessing unit is electrically connected to the pulse generator and is used to preprocess the original intracavitary electrocardiogram data to obtain the to-be-used intracavitary electrocardiogram data;

[0018] The first storage unit is electrically connected to the intracavitary electrocardiogram data preprocessing unit, and is used to store the standby intracavitary electrocardiogram data, and is also used to read and store the program-controlled parameter combination from the pulse generator.

[0019] Furthermore, the intracavitary electrocardiogram data processing module includes a third storage unit, a plurality of registers, a plurality of comparators and a plurality of counters;

[0020] The registers include a first register, a second register, a third register and a fourth register;

[0021] The first register is used to read the intracavitary electrocardiogram data of the standby cavity;

[0022] The second register is used to read the preset fluctuation value in the preset parameter combination;

[0023] The third register is used to store the preset critical value in the preset parameter combination;

[0024] The comparator includes a first comparator, a second comparator and a third comparator;

[0025] The first comparator is electrically connected to the first register and the second register respectively, and is used to determine whether each data point of the to-be-used intracavitary electrocardiogram data is outside the fluctuation range defined by the preset fluctuation value, and if the data point is outside the fluctuation range defined by the preset fluctuation value, the data point is a valid point;

[0026] The fourth register is used to store the accumulated calculated value of all valid points of a set of to-be-used intracavitary electrocardiogram data;

[0027] The second comparator is electrically connected to the third register and the fourth register respectively, and is used to compare the accumulated calculation value with the preset critical value and output a corresponding comparison result, wherein the comparison result includes a capture determination and a loss of capture determination;

[0028] The first input terminal of the third register is electrically connected to the second comparator, the second input terminal of the third register inputs the theoretical result of the to-be-used intracavitary electrocardiogram data, and the third register is used to compare the comparison result with the theoretical result, wherein the theoretical result includes theoretical capture and theoretical loss of capture;

[0029] The counter includes a second counter, a third counter, a fourth counter and a fifth counter electrically connected to the third comparator respectively;

[0030] The second counter is used to count once when the determined capture and the theoretical capture are input to the input terminal of the third comparator at the same time;

[0031] The third counter is used to count once when the determined loss of capture and the theoretical loss of capture are input to the input terminal of the third comparator at the same time;

[0032] The fourth counter is used to count once when the determined capture and the theoretical loss of capture are input to the input terminal of the third comparator at the same time;

[0033] The fifth counter is used to count once when the determined loss of capture and the theoretical capture are input to the input terminal of the third comparator at the same time;

[0034] The third storage unit is used to store the capture accuracy rate and the loss-capture accuracy rate of the preset parameter combination.

[0035] Further, the signal indication module includes a fifth register, a sixth register, a seventh register, a fourth comparator and a fifth comparator;

[0036] The fifth register is used to store a usage standard, wherein the usage standard is a minimum standard for the capture accuracy and the loss-of-capture accuracy of the preset parameter combination to meet usage requirements, including a minimum capture accuracy and a minimum loss-of-capture accuracy;

[0037] The sixth register is electrically connected to the third storage unit of the intracavitary electrocardiogram data processing module, and is used to read the program-controlled parameter combination from the database, and obtain the capture accuracy and loss-of-capture accuracy of the program-controlled parameter combination from the third storage unit;

[0038] The seventh register is electrically connected to the third storage unit and is used to determine an alternative preset parameter combination, where the alternative preset parameter combination is a preset parameter combination with the highest capture accuracy and a corresponding loss of capture accuracy of 100%;

[0039] The fourth comparator is electrically connected to the fifth register and the sixth register, respectively, and is used to compare the capture accuracy rate and the loss-of-capture accuracy rate of the program-controlled parameter combination with the minimum capture accuracy rate and the minimum loss-of-capture accuracy rate corresponding to the usage standard, and output a corresponding first operation instruction;

[0040] The fifth comparator is electrically connected to the fourth comparator and the seventh register, respectively, and is used to compare the capture accuracy and loss-of-capture accuracy of the programmed parameter combination with the capture accuracy and loss-of-capture accuracy corresponding to the alternative preset parameter combination, and output a corresponding second operation instruction.

[0041] In a second aspect, the present application provides an early warning method for an implantable pulse generator, comprising the following steps:

[0042] Acquiring original intracavitary electrocardiogram data and a program-controlled parameter combination, wherein the program-controlled parameter combination is a parameter used in a pulse generator;

[0043] Preprocessing the original intracavitary electrocardiogram data to obtain the intercavitary electrocardiogram data to be used;

[0044] Determining theoretical results of the to-be-used intracavitary electrocardiogram data, wherein the theoretical results include theoretical capture and theoretical loss of capture;

[0045] Determine the capture accuracy and loss-of-capture accuracy of the to-be-used intracavitary electrocardiogram data by a preset parameter combination, wherein the programmable parameter combination is a set of parameter combinations in the preset parameter combination;

[0046] The warning level of the program-controlled parameter combination is determined according to the usage standard and the capture accuracy rate and loss-of-capture accuracy rate of the preset parameter combination, wherein the usage standard is that the capture accuracy rate and loss-of-capture accuracy rate of the preset parameter combination meet the minimum standard of usage requirements, including the minimum capture accuracy rate and the minimum loss-of-capture accuracy rate.

[0047] Furthermore, determining the warning level of the program-controlled parameter combination according to the usage standard and the capture accuracy and loss of capture accuracy of the preset parameter combination includes the following steps:

[0048] S1: Obtaining the minimum capture accuracy and the minimum loss of capture accuracy of the usage standard;

[0049] S2: Obtaining the capture accuracy and the loss-capture accuracy of the preset parameter combination;

[0050] S3: determining an alternative preset parameter combination, wherein the alternative preset parameter combination is a preset parameter combination having the highest capture accuracy among all the preset parameter combinations and a corresponding loss of capture accuracy of 100%;

[0051] S4: comparing the loss-of-capture accuracy of the program-controlled parameter combination with the minimum loss-of-capture accuracy; if the loss-of-capture accuracy of the program-controlled parameter combination is inconsistent with the minimum loss-of-capture accuracy, the warning level of the program-controlled parameter combination is level 1; otherwise, proceed to S5;

[0052] S5: comparing the capture accuracy of the program-controlled parameter combination with the minimum capture accuracy; if the capture accuracy of the program-controlled parameter combination is less than the minimum capture accuracy, the warning level of the program-controlled parameter combination is level 2; otherwise, proceed to S6;

[0053] S6: comparing the capture accuracy of the program-controlled parameter combination with the capture accuracy of the alternative preset parameter combination; if the capture accuracy of the program-controlled parameter combination is lower than the capture accuracy of the alternative preset parameter combination, the warning level of the program-controlled parameter combination is level 3; otherwise, proceed to S7;

[0054] S7: Evaluate two sets of preset parameter combinations adjacent to the programmed parameter combination based on the alternative preset parameter combination, the two sets of preset parameter combinations being preset parameter combinations whose preset critical values are adjacent to the preset critical value of the programmed parameter combination, and whose preset critical value is an intermediate value. If the capture accuracy rates of the two sets of preset parameter combinations are consistent with the capture accuracy rate of the alternative preset parameter combination, and the loss-of-capture accuracy rates of the two sets of preset parameter combinations are consistent with the loss-of-capture accuracy rate of the alternative preset parameter combination, then the warning level of the programmed parameter combination is level five; otherwise, the warning level of the programmed parameter combination is level four.

[0055] Furthermore, the method comprises the following steps:

[0056] S1: The second register obtains the preset fluctuation value of the preset parameter combination;

[0057] S2: The third register obtains a set of preset critical values of the preset parameter combination;

[0058] S3: The first register obtains a set of standby intracavitary electrocardiogram data;

[0059] S4: If the standby intracavitary electrocardiogram data corresponds to the first pacing pulse, a high level is input to the second input terminal of the third comparator, indicating that the theoretical state of the standby intracavitary electrocardiogram data is theoretical capture;

[0060] If the pair of intracavitary electrocardiogram data to be used corresponds to the second pacing pulse, the second input terminal of the third comparator inputs a low level, indicating that the theoretical state of the intracavitary electrocardiogram data to be used is theoretical loss of capture;

[0061] S5: Reading a data point of the to-be-used intracavitary electrocardiogram data from the first register;

[0062] S6: If the data point is outside the fluctuation range defined by the preset fluctuation value stored in the second register, the data point is a valid point and the process goes to S7; otherwise, the data point is an invalid point and the process goes to S8;

[0063] S7: adding the calculated value of the data point to the calculated value of the previous data point to obtain an accumulated calculated value, storing the accumulated calculated value in a fourth register, and proceeding to S8;

[0064] S8: If the data point is the last data point of the to-be-used intracavitary electrocardiogram data, proceed to S9; otherwise, read the next data point of the to-be-used intracavitary electrocardiogram data and proceed to S6;

[0065] S9: If the accumulated calculated value in the fourth register is greater than the preset critical value in the third register, the second comparator inputs a high level to the first input terminal of the third comparator, indicating that the preset parameter combination determines that the state of the stand-by intracavitary electrocardiogram data is captured;

[0066] Otherwise, the second comparator inputs a low level to the first input terminal of the third comparator, indicating that the preset parameter combination determines that the state of the standby intracavitary electrocardiogram data is loss of capture;

[0067] S10: If the first input terminal and the second input terminal of the third comparator are both at a high level, the second counter performs one count;

[0068] If the first input terminal and the second input terminal of the third comparator are both at a low level, the third counter performs one count;

[0069] If the first input terminal of the third comparator is at a high level and the second input terminal is at a low level, the fourth counter counts once;

[0070] If the first input terminal of the third comparator is at a low level and the second input terminal is at a high level, the fifth counter counts once;

[0071] S11: If the standby intracavitary electrocardiogram data in the first register is not the last set of standby intracavitary electrocardiogram data, proceed to S12; otherwise, proceed to S13;

[0072] S12: the first register obtains the next set of standby intracavitary electrocardiogram data and proceeds to S4;

[0073] S13: determining a capture accuracy rate and a loss of capture accuracy rate of the preset parameter combination according to the counting results of the second counter, the third counter, the fourth counter, and the fifth counter, and saving the capture accuracy rate and the loss of capture accuracy rate of the preset parameter combination to a third storage unit;

[0074] S14: Clearing data in the fourth register, the second counter, the third counter, the fourth counter, and the fifth counter;

[0075] S15: If the preset critical value obtained by the third register is not the preset critical value of the last set of the preset parameter combination, the third register obtains the preset critical value of the next set of preset parameter combination and performs S3; otherwise, the preset parameter combination processing is completed.

[0076] Furthermore, the capture accuracy rate and the loss capture accuracy rate are calculated using the following formulas:

[0077]

[0078]

[0079] The technical solution provided by this application includes the following beneficial technical effects:

[0080] The present application provides an early warning system and method for an implantable pulse generator, the system comprising an intracavitary electrocardiogram (ICG) data acquisition module, a Bluetooth module, an intracavitary electrocardiogram (ICG) data processing module, a signal indication module, and a pulse generator; the pulse generator is used to emit pacing pulses and collect original ICG data; the ICG data acquisition module is electrically connected to the pulse generator, and is used to read the programmed parameter combination in the pulse generator, and is also used to control the pulse generator to collect original ICG data, and pre-process the original ICG data to obtain stand-by ICG data; the Bluetooth module is electrically connected to the ICG data acquisition module, and is used to communicate with a mobile terminal; the ICG data processing module is used to obtain the capture accuracy and loss-of-capture accuracy of the stand-by ICG data by a preset parameter combination, wherein the programmed parameter combination is a group of parameter combinations in the preset parameter combination; the information indication module is electrically connected to the ICG data processing module, and is used to determine the early warning level of the programmed parameter combination, and display an operation indication corresponding to the early warning level. The method includes obtaining original intracavitary electrocardiogram (ICE) data and a programmable parameter combination used in a pulse generator; preprocessing the original intracavitary electrocardiogram (ICE) data to obtain standby intracavitary electrocardiogram (SEEG) data; determining theoretical results of the standby intracavitary electrocardiogram (SEEG) data, the theoretical results including theoretical capture and theoretical loss of capture; determining the capture accuracy and loss of capture accuracy of the preset parameter combination for the SEEG data to be used; and determining the warning level of the programmable parameter combination based on the capture accuracy and loss of capture accuracy of the preset parameter combination using the standard and the preset parameter combination. Using the early warning system and method for an implantable pulse generator provided by the present application can change the previous clinical passive monitoring method of pacing thresholds and change the management method of pacing thresholds to active monitoring. On the one hand, remote monitoring of the automatic pacing threshold capture function can be achieved, thereby improving the reliability of the implantable pulse generator. On the other hand, by determining the warning level of the programmable parameter combination of the automatic pacing threshold capture function, automatic optimization of the programmable parameter combination can be achieved, thereby ensuring the effectiveness of the pacing pulse and only reminding the user to go to the clinic for follow-up when necessary, thereby reducing unnecessary on-site follow-up work. BRIEF DESCRIPTION OF THE DRAWINGS

[0081] Figure 1 Schematic diagram of regular follow-up for implantable pulse generator users;

[0082] Figure 2 Schematic diagram of automatic pacing threshold capture function with beat-by-beat detection function;

[0083] Figure 3 Schematic diagram of the automatic pacing threshold capture function when intracavitary electrocardiogram data changes;

[0084] Figure 4 A schematic diagram of an early warning system for an implantable pulse generator provided in an embodiment of the present application;

[0085] Figure 5 A comparison between the early warning system solution for an implantable pulse generator provided in an embodiment of the present application and the prior art;

[0086] Figure 6 A schematic diagram of the composition of an early warning system for an implantable pulse generator provided in an embodiment of the present application;

[0087] Figure 7 This is a circuit block diagram of an intracavitary electrocardiogram data acquisition module and a Bluetooth module for an early warning system for an implantable pulse generator provided in an embodiment of the present application;

[0088] Figure 8 A circuit block diagram of an intracavitary electrocardiogram data processing module for an early warning system for an implantable pulse generator provided in an embodiment of the present application;

[0089] Figure 9 A circuit block diagram of a signal indication module for an early warning system for an implantable pulse generator provided in an embodiment of the present application;

[0090] Figure 10 A schematic diagram of signal indication provided in an embodiment of the present application;

[0091] Figure 11 An example of the ECG data processing results provided in the embodiments of this application;

[0092] Figure 12 The normal intracavitary electrocardiogram provided in the embodiment of the present application;

[0093] Figure 13 An intracavitary electrocardiogram of an electrode dislocation provided in an embodiment of the present application;

[0094] Figure 14 An abnormal intracavitary electrocardiogram is provided in an embodiment of the present application.

[0095] Description of the accompanying drawings: 1-implantable pulse generator, 2-mobile terminal, 3-intracavitary electrocardiogram data processor, 100-intracavitary electrocardiogram data acquisition module, 101-timer, 102-first counter, 103-timer, 104-intracavitary electrocardiogram data preprocessing unit, 105-first storage unit, 200-Bluetooth module, 300-intracavitary electrocardiogram data processing module, 301-first register, 302-second register, 303-third register, 304-first comparator, 305-fourth register, 306-second comparator, 307-third comparator, 308-fourth register, 309-fourth comparator, 310-fourth comparator, 311-fourth comparator, 312-fourth comparator, 313-fourth comparator, 314-fourth comparator, 315-fourth comparator, 316-fourth comparator, 317-fourth comparator, 318-fourth comparator, 319-fourth comparator, 320-fourth comparator, 321-fourth comparator, 322-fourth comparator, 323-fourth comparator, 324-fourth comparator, 325-fourth comparator, 326-fourth comparator, 327-fourth comparator, 328-fourth comparator, 329-fourth comparator, 330-fourth comparator, 8-second counter, 309-third counter, 310-fourth counter, 311-fifth counter, 312-third storage unit, 400-signal indication module, 401-fifth register, 402-sixth register, 403-seventh register, 404-fourth comparator, 405-fifth comparator, 406-red indicator light, 407-orange indicator light, 408-yellow indicator light, 409-blue indicator light, 410-green indicator light, 500-implantable pulse generator, 501-pacing circuit, 502-sensing circuit, 503-second storage unit. DETAILED DESCRIPTION

[0096] To facilitate the description and understanding of the technical solution of the application, some abbreviations and other concepts involved in this application are first explained below.

[0097] Xp: pacing pulse, which can be atrial pacing pulse or ventricular pacing pulse;

[0098] Xp(F): first pacing pulse, which can be the first atrial pacing pulse or the first ventricular pacing pulse;

[0099] Xp(S): second pacing pulse, which can be the second atrial pacing pulse or the second ventricular pacing pulse;

[0100] Vp(F): first ventricular pacing pulse;

[0101] Vp(S): second ventricular pacing pulse;

[0102] Vp: ventricular pacing pulse;

[0103] Vs: intrinsic ventricular excitation.

[0104] The technical solution of the present application is further described below with reference to the accompanying drawings and embodiments.

[0105] See also Figure 4 , is a schematic diagram of the early warning system for an implantable pulse generator provided in an embodiment of the present application. Figure 4As shown, the early warning system provided by the embodiment of the present application has an intracavitary electrocardiogram (ICEG) data acquisition module embedded in the implantable pulse generator 1, which can regularly collect the user's IECG data and send the IECG data to the user's mobile terminal 2, such as a mobile phone or tablet computer or other personal device, via Bluetooth. The user's mobile phone or tablet computer or other personal device then sends the IECG data to the database via a mobile network or Wi-Fi. The IECG data processor 3 located at the network terminal can analyze the collected IECG data and indicate the reliability of the user's automatic pacing threshold capture function. If it is detected that the automatic pacing threshold capture function has a better preset parameter combination, the mobile network or Wi-Fi is used to feed back the better preset parameter combination to the pulse generator via Bluetooth through the user's mobile phone or tablet computer or other personal device, so as to achieve the purpose of optimizing the pulse generator. If necessary, the user is reminded to go to the clinic for follow-up by phone to ensure that the pulse generator can work normally. For example, for Figure 3 In the situation shown in , the intracavitary electrocardiogram data processor 3 will be able to identify at time T3 that the reliability of the automatic pacing threshold capture function is reduced. Therefore, the user can be reminded by phone to go to the clinic for follow-up and the parameter settings of the pulse generator can be optimized in time to ensure the effectiveness of the pacing pulse.

[0106] See also Figure 5 , is a comparison between the early warning system solution for implantable pulse generator provided by the embodiment of the present application and the prior art. Figure 5 As shown in , this early warning system solution has the following advantages:

[0107] First, it changed the previous clinical passive monitoring method of pacing thresholds to active monitoring;

[0108] Second, the reliability of the implantable pulse generator is improved by remote monitoring of the automatic pacing threshold capture function;

[0109] Third, the effectiveness of the pacing pulse is ensured by automatically optimizing the programmable parameter combination of the automatic pacing threshold capture function;

[0110] Fourth, users are reminded to go to the clinic for follow-up only when necessary, reducing unnecessary on-site follow-up work.

[0111] The following is a detailed description of the early warning system for an implantable pulse generator provided in an embodiment of the present application.

[0112] See also Figure 6, which is a schematic diagram of the composition of an early warning system for an implantable pulse generator provided in an embodiment of the present application, mainly includes four basic modules and a portion of an existing pulse generator 500. The four basic modules are: an intracavitary electrocardiogram (ICEG) data acquisition module 100, a Bluetooth module 200, an intracavitary electrocardiogram (ICEG) data processing module 300, and a signal indication module 400. The IECG data acquisition module 100 and the Bluetooth module 200 are built on the pulse generator 500, while the IECG data processing module 300 and the signal indication module 400 are built on a network terminal.

[0113] For details, see Figure 7 , which is a circuit block diagram of the intracavitary electrocardiogram data acquisition module 100 and the Bluetooth module 200 of the early warning system for an implantable pulse generator provided in an embodiment of the present application.

[0114] Figure 7The figure also shows the parts of the pulse generator 500 associated with the intracavitary ECG data acquisition module 100, including the pacing circuit 501, the sensing circuit 502, and the second storage unit 503. The intracavitary ECG data acquisition module 100 includes a timer 101, a first counter 102, a timer 103, an intracavitary ECG data preprocessing unit 104 consisting of a filter, an amplifier, and an A / D converter, and a first storage unit 105. When the set time arrives, the timer 101 triggers the intracavitary ECG data acquisition module 100 to start operating through the pulse generator 500. The first storage unit 105 of the intracavitary electrocardiogram data acquisition module 100 is electrically connected to the second storage unit 503 of the pulse generator 500, and reads the programmed parameter combination for collecting the original intracavitary electrocardiogram data programmed by the user from the second storage unit 503. The programmed parameter combination includes a preset collection area consisting of a collection start point and a collection end point, a preset fluctuation value and a preset critical value. At the same time, the timer 103 reads the collection start point T1 and the collection end point T2 of the preset collection area of the programmed parameter combination from the second storage unit 503, wherein the collection start point T1 and the collection end point T2 are within 20ms to 100ms after the pacing pulse. When the pacing circuit 501 delivers a pacing pulse Xp, the timer 103 starts its timing function. Timer 103 has three functions: first, it enables the intracavitary electrocardiogram (ICEG) data preprocessing unit 104 to read the raw ICEG data collected by the sensing circuit 502 within the interval from the acquisition start point T1 to the acquisition end point T2 after the first pacing pulse Xp(F); second, it triggers the pacing circuit 501 to deliver the second pacing pulse Xp(S) at 120 ms; and third, it enables the ICEG data preprocessing unit 104 to read the raw ICEG data collected by the sensing circuit 502 within the interval from the acquisition start point T1 to the acquisition end point T2 after the second pacing pulse Xp(S). The read raw ICEG data is processed by the ICEG data preprocessing unit 104 to obtain the ready-to-use ICEG data, which is then stored in the first storage unit 105. Counter 102 is used to record the number of sets of raw ICEG data to be collected, with an optional range of 20 to 200, a step size of 20, and a default value of 40. After the intracavitary electrocardiogram data acquisition module 100 starts working, each time the pacing circuit 501 emits a first pacing pulse Xp(F) or a second pacing pulse Xp(S), the counter 102 records a pacing event, that is, the number of groups of original intracavitary electrocardiogram data collected. When the number of recorded groups reaches a preset value, the counter 102 will trigger the Bluetooth module 200 to send the stand-by intracavitary electrocardiogram data and programmed parameter combination in the first storage unit 105 to the user's personal device such as a mobile phone or tablet computer.

[0115] See also Figure 8 , is a circuit block diagram of an intracavitary electrocardiogram data processing module for an early warning system for an implantable pulse generator provided in an embodiment of the present application. Figure 8As shown in , the IECG data processing module 300 consists of registers, comparators, counters, and storage units. The IECG data and programmable parameter combinations stored in the user's personal device, such as a mobile phone or tablet, are sent to a backend database via a mobile network or Wi-Fi. The IECG data processing module 300 can read the IECG data and programmable parameter combinations in the database. A first register 301 is used to read the IECG data in the database. A second register 302 is used to read the preset fluctuation value from a preset parameter combination in the database. The programmable parameter combination is a set of parameter combinations within the preset parameter combination. The same preset parameter combination includes a preset acquisition area, a preset fluctuation value, and a preset critical value. A third register 303 is used to store the preset critical value, with an optional range of 1 to 16 and a step size of 1. A first comparator 304 is used to determine whether each data point in the IECG data in use is outside the preset fluctuation value, that is, the positive and negative fluctuation range of the baseline. Data points outside the positive and negative fluctuation range are considered valid points. The fourth register 305 is used to store the cumulative calculated value of all valid points in the pending intracavitary electrocardiogram data. This calculated value can be the absolute value of the valid points based on the baseline, i.e., the amplitude value. The second comparator 306 is used to determine the capture or loss of capture status of the current pending intracavitary electrocardiogram data at the current preset critical value, outputting a high level if capture is determined and a low level if loss of capture is determined. Taking the total amplitude as an example, the amplitude corresponding to the 16 preset critical values ranges from 25 to 100 mV, with a step size of 5 mV. If the preset critical value of the third register 303 is 50 mV, i.e., a value of 6, and the preset fluctuation value read by the second register 302 is 2 mV, the first comparator 304 considers data points outside the baseline ±2 mV as valid points. The total amplitude value of the fourth register 305 is the sum of the absolute values of all valid points. If the total amplitude value of the fourth register 305 is greater than 50 mV, a high level is output; otherwise, a low level is output. The first input terminal V1 of the third comparator 307 receives the output level of the second comparator 306. If the intracavitary electrocardiogram data currently in use in the first register 301 is the intracavitary electrocardiogram data corresponding to the first pacing pulse Xp(F), that is, the intracavitary electrocardiogram data currently in use is a capture wave in the theoretical sense, then a high level is input to the second input terminal V2 of the third comparator 307. If the intracavitary electrocardiogram data currently in use in the first register 301 is the intracavitary electrocardiogram data corresponding to the second pacing pulse Xp(S), that is, the intracavitary electrocardiogram data currently in use is a loss-of-capture wave in the theoretical sense, then a low level is input to the second input terminal V2 of the third comparator 307.The second counter 308, the third counter 309, the fourth counter 310, and the fifth counter 311 are respectively used to record the results of the capture and loss-of-capture determination of the intracavitary electrocardiogram data to be used based on a preset parameter combination. The second counter 308 is used to record the number of times the first input terminal V1 and the second input terminal V2 of the third comparator 307 are both at a high level; the third counter 309 is used to record the number of times the first input terminal V1 and the second input terminal V2 of the third comparator 307 are both at a low level; the fourth counter 310 is used to record the number of times the first input terminal V1 of the third comparator 307 is at a high level and the second input terminal V2 is at a low level; and the fifth counter 311 is used to record the number of times the first input terminal V1 of the third comparator 307 is at a low level and the second input terminal V2 is at a high level. The third storage unit 312 is used to store 16 preset parameter combinations and the accuracy rates of the capture and loss-of-capture determinations of the intracavitary electrocardiogram data to be used based on the 16 preset parameter combinations.

[0116] See also Figure 9 , is a circuit block diagram of the signal indication module for the early warning system for an implantable pulse generator provided in an embodiment of the present application. The signal indication module 400 is composed of a register, a comparator, and a signal indicator light. The fifth register 401 stores a usage standard, which is the minimum standard for the capture accuracy and loss of capture accuracy of a preset parameter combination to meet the usage requirements, including the minimum capture accuracy and the minimum loss of capture accuracy. For example, the minimum capture accuracy of this usage standard can be selected from 50% to 100% with a step size of 5% and a default value of 80%. The minimum loss of capture accuracy standard is not selectable and is fixed at 100%. The sixth register 402 is electrically connected to the third storage unit 312 of the intracavitary electrocardiogram data processing module 300. It reads the programmable parameter combination from the database and reads the capture accuracy and loss of capture accuracy of the programmable parameter combination from the third storage unit 312. The seventh register 403 is electrically connected to the third storage unit 312 and reads from the third storage unit 312 the alternative preset parameter combination with the highest capture accuracy and a corresponding loss-of-capture accuracy of 100%, as well as the capture accuracy and loss-of-capture accuracy of the alternative preset parameter combination. A fifth comparator 405 is configured to compare the capture accuracy and loss-of-capture accuracy of the program-controlled parameter combination with the capture accuracy and loss-of-capture accuracy corresponding to the alternative preset parameter combination. Five signal indicators are configured to display the warning level corresponding to the program-controlled parameter combination.

[0117] The working process of the signal indication module 400 is as follows:

[0118] The sixth register 402 reads the program-controlled parameter combination and its capture accuracy and loss-of-capture accuracy. The fourth comparator 404 compares the capture accuracy and loss-of-capture accuracy of the program-controlled parameter combination with the usage standard stored in the fifth register 401. If the loss-of-capture accuracy of the program-controlled parameter combination does not meet the following conditions:

[0119] The accuracy of loss of program-controlled parameter combination = 100%,

[0120] The warning level of the program-controlled parameter combination is level 1, and the red indicator light 406 is set to a high level;

[0121] Otherwise, if the capture accuracy of the program-controlled parameter combination does not meet the following conditions:

[0122] The capture accuracy of the program-controlled parameter combination ≥ the minimum capture accuracy,

[0123] The warning level of the program-controlled parameter combination is level 2, and the orange indicator light 407 is set to a high level;

[0124] Otherwise, the fifth comparator 405 works and needs to further perform the following determination process:

[0125] If the capture accuracy of the program-controlled parameter combination meets the following conditions:

[0126] The capture accuracy of the program-controlled parameter combination is less than the capture accuracy of the alternative preset parameter combination.

[0127] The warning level of the program-controlled parameter combination is level three, and the yellow indicator light 408 is set to a high level;

[0128] Otherwise, the following judgment process needs to be further performed:

[0129] Two sets of preset parameter combinations adjacent to the programmed parameter combination are determined from the candidate preset parameter combinations, wherein the two sets of preset parameter combinations are two sets of preset parameter combinations whose preset critical values are adjacent to the preset critical value of the programmed parameter combination and whose preset critical value of the programmed parameter combination is an intermediate value, and if the capture accuracy and the loss-of-capture accuracy of the two sets of preset parameter combinations meet the following two conditions:

[0130] The capture accuracy of the two sets of preset parameter combinations adjacent to the program-controlled parameter combination = the capture accuracy of the alternative preset parameter combination,

[0131] The loss-recapture accuracy of the two preset parameter combinations adjacent to the programmed parameter combination = 100%,

[0132] The warning level of the program-controlled parameter combination is level five, and the green indicator light 410 is set to a high level;

[0133] Otherwise, the warning level of the program-controlled parameter combination is level four, and the blue indicator light 409 is set to a high level.

[0134] See also Figure 10 , is a schematic diagram of signal indication provided by the embodiment of the present application. Figure 10As shown in the , the display can display the ECG data analysis results of all users through different indicator colors. One page can display the ECG data analysis results of 24 users, and mark orange and red signals as abnormal. The user with abnormal ECG data analysis results is automatically displayed at the top. The meaning of each color signal is explained below:

[0135] Green signal: Under the programmed parameter combination, the reliability of the automatic pacing threshold capture function is very high and no treatment is required.

[0136] Blue signal: Under the programmed parameter combination, the reliability of the automatic pacing threshold capture function is high. If there is a green preset parameter combination among the 16 preset parameter combinations, the preset parameter combination will be fed back to the pulse generator via Bluetooth through the user's mobile phone or tablet computer and other personal devices using mobile network or Wi-Fi to achieve the purpose of optimizing the pulse generator.

[0137] Yellow signal: Under the programmed parameter combination, the reliability of the automatic pacing threshold capture function is moderate. If a green or blue preset parameter combination exists among the 16 preset parameter combinations (the green preset parameter combination is preferred), the parameter combination will be fed back to the pulse generator via Bluetooth through the user's personal device such as a mobile phone or tablet computer using a mobile network or Wi-Fi to achieve the purpose of optimizing the pulse generator.

[0138] Orange signal: Under the programmed parameter combination, the reliability of the automatic pacing threshold capture function is low. The user should be reminded by phone immediately to go to the clinic for follow-up to eliminate the risk of electrode lead dislocation and optimize the pulse generator parameter settings in a timely manner to ensure the effectiveness of the pacing pulse.

[0139] Red signal: Under the programmed parameter combination, the reliability of the automatic pacing threshold capture function is very low. The user should be reminded by phone immediately to go to the clinic for follow-up to eliminate risks such as electrode lead dislocation or abnormal perception, and the parameter settings of the pulse generator should be optimized in time to ensure the effectiveness of the pacing pulse.

[0140] See also Figure 11 , is an example of the ECG data processing result provided by the embodiment of the present application. This further explains the working principle of the early warning system for implantable pulse generator provided by the embodiment of the present application. If the acquisition starting point, acquisition end point, and preset fluctuation value of the preset parameter combination are 8, 15, and 3 respectively, then after processing the ECG data of the cavity to be used, the following will be obtained: Figure 11 16 preset parameter combinations with different preset thresholds and the corresponding capture and loss accuracy rates are shown. Figure 11It also lists the signal light colors corresponding to the 16 preset parameter combinations when they are used as program parameter combinations. For example, if the program parameter combination is 8-15-3-7, the green indicator light 410 is set to a high level and no processing is required; if the program parameter combination is 8-15-3-10, the blue indicator light 409 is set to a high level, and the preset parameter combination 8-15-3-8 should be fed back to the pulse generator to achieve the optimization purpose; if the program parameter combination is 8-15-3-11, the yellow indicator light is set to a high level. The indicator light 408 is set to a high level, and the parameter combination 8-15-3-8 should be fed back to the pulse generator to achieve the optimization purpose; if the program parameter combination is 8-15-3-14, the orange indicator light 407 is set to a high level, and the user should be reminded by phone immediately to go to the clinic for follow-up to eliminate the risk of electrode lead dislocation; if the program parameter combination is 8-15-3-4, the red indicator light 406 is set to a high level, and the user should be reminded by phone immediately to go to the clinic for follow-up to eliminate the risk of electrode lead dislocation or abnormal perception.

[0141] Specifically, the examples provided in this application are as follows Figure 8 Based on the intracavitary electrocardiogram data processing module of the early warning system for an implantable pulse generator shown in the figure, the early warning method for an implantable pulse generator provided in the embodiment of the present application is as follows:

[0142] S1: The second register 302 obtains a preset fluctuation value of a preset parameter combination from a database;

[0143] S2: The third register 303 obtains a set of preset critical values of a preset parameter combination;

[0144] S3: The first register 301 obtains a set of standby intracavitary electrocardiogram data from the database;

[0145] S4: If the set of standby intracavitary electrocardiogram data corresponds to the first pacing pulse Xp(F), a high level is input to the second input terminal V2 of the third comparator 307, indicating that the theoretical state of the standby intracavitary electrocardiogram data is theoretical capture;

[0146] If it corresponds to the second pacing pulse Xp(S), the second input terminal V2 of the third comparator 307 inputs a low level, indicating that the theoretical state of the to-be-used intracavitary electrocardiogram data is theoretical loss of capture;

[0147] S5: Read a data point of the currently used intracavitary electrocardiogram data from the first register 301;

[0148] S6: If the read data point is outside the fluctuation range defined by the preset fluctuation value stored in the second register 302, the data point is a valid point and the process goes to S7; otherwise, the data point is an invalid point and the process goes to S8;

[0149] S7: Add the calculated value of the data point to the calculated value of the previous data point, store the accumulated calculated value in the fourth register 305, and proceed to S8;

[0150] S8: If the current data point is the last data point of the currently used intracavitary electrocardiogram data, proceed to S9; otherwise, read the next data point of the current intracavitary electrocardiogram data and proceed to S6;

[0151] S9: If the accumulated value obtained by the fourth register 305 is greater than the current preset critical value in the third register 303, the second comparator 306 outputs a high level, indicating that the current preset parameter combination identifies the state of the currently used intracavitary electrocardiogram data as captured; otherwise, the second comparator 306 outputs a low level, indicating that the current preset parameter combination identifies the state of the currently used intracavitary electrocardiogram data as lost capture.

[0152] S10: If the first input terminal V1 and the second input terminal V2 of the third comparator 307 are both at a high level, it indicates that the current preset parameter combination identifies the current standby intracavitary electrocardiogram data as captured and is consistent with the theoretical capture state in the theoretical sense, and a count is performed by the second counter 308;

[0153] If the first input terminal V1 and the second input terminal V2 of the third comparator 307 are both at a low level, it indicates that the current preset parameter combination identifies the current standby intracavitary electrocardiogram data as loss of capture and is consistent with the theoretical loss of capture state, and the third counter 309 performs a count once.

[0154] If the first input terminal V1 of the third comparator 307 is at a high level and the second input terminal V2 is at a low level, it indicates that the current preset parameter combination identifies the current standby intracavitary electrocardiogram data as captured and inconsistent with the theoretical loss of capture state in the theoretical sense, and the fourth counter 310 performs one count;

[0155] If the first input terminal V1 of the third comparator 307 is at a low level and the second input terminal V2 is at a high level, it indicates that the current preset parameter combination identifies the current standby intracavitary electrocardiogram data as loss of capture and is inconsistent with the theoretical capture state in the theoretical sense, and a count is performed through the fifth counter 311.

[0156] S11: If the standby intracavitary electrocardiogram data in the first register 301 is not the last set of standby intracavitary electrocardiogram data in the database, proceed to S12; otherwise, proceed to S13;

[0157] S12: The first register 301 obtains the next set of standby intracavitary electrocardiogram data from the database and proceeds to S4;

[0158] S13: Calculate the capture accuracy and loss-of-capture accuracy of the capture and loss-of-capture state determination of all pending intracavitary electrocardiogram data using the current preset parameter combination based on the counting results of the second counter 308, the third counter 309, the fourth counter 310, and the fifth counter 311, and save the calculation results to the third storage unit 312, thus completing the processing of the pending intracavitary electrocardiogram data using the current preset parameter combination.

[0159]

[0160]

[0161] S14: Clear the data in the fourth register 305, and clear the data in the second counter 308, the third counter 309, the fourth counter 310, and the fifth counter 311;

[0162] S15: If the preset critical value currently obtained by the third register 303 is not the preset critical value in the last set of preset parameter combinations, the third register 303 obtains the preset critical value of the next set of preset parameter combinations and performs S3; otherwise, the preset parameter combination is used to complete the processing of the waiting intracavitary electrocardiogram data.

[0163] Taking ventricular pacing as an example, the working method of the early warning system for an implantable pulse generator provided by the embodiment of the present application is explained through several sets of intracavitary electrocardiogram examples.

[0164] See also Figure 12 , is the normal intracavitary electrocardiogram provided by the embodiment of the present application. Figure 12 As shown in FIG, when timer 101 triggers the IEC data acquisition module 100 to operate, it collects IEC data for the first and second ventricular pacing pulses Vp(F) and Vp(S) within the IEC data acquisition window. If intrinsic ventricular excitation Vs occurs, this event is ignored. Because the second ventricular pacing pulse Vp(S) falls within the myocardial refractory period, Vp(S) cannot capture myocardium. This IEC data acquisition method can capture both captured and uncaptured IEC data without disrupting the user's normal heart rhythm. Because the IEC data is not collected by increasing the pacing frequency, there is a certain probability that the collected IEC data for the first ventricular pacing pulse Vp(F) will be interfered with by fusion waves, resulting in a capture accuracy rate less than 100% obtained by the IEC data processing module 300. Therefore, the default minimum capture accuracy standard is set at 80%, rather than 100%, and yellow signals are not classified as abnormal. Generally, green or blue signals are obtained after processing of intraventricular electrocardiogram data. When occasional fusion waves affect the intraventricular electrocardiogram data of the first ventricular pacing pulse Vp(F), yellow signals may also be obtained.

[0165] See also Figure 13 , is the intracavitary electrocardiogram of the electrode dislocation provided in the embodiment of the present application. Figure 13 As shown by arrows ① and ②, neither the first ventricular pacing pulse Vp(F) nor the second ventricular pacing pulse Vp(S) can capture myocardial myocardium. In this case, the capture accuracy is 0%, and therefore, the intracavitary ECG data processing will produce an orange signal. Furthermore, if intrinsic ventricular activation Vs occurs at the location of the second ventricular pacing pulse Vp(S), the capture accuracy may decrease, resulting in a red signal after intracavitary ECG data processing. When red or orange signals appear, the user should be notified by phone to visit the clinic for follow-up. If electrode dislocation is confirmed, prompt treatment should be provided to ensure the proper functioning of the pulse generator.

[0166] See also Figure 14 , which is an abnormally sensed intracavitary electrocardiogram provided by an embodiment of the present application. At this time, the sensing circuit 502 of the pulse generator 500 cannot correctly sense the user's own ventricular excitation Vs. On the one hand, the collected intracavitary electrocardiogram data of the first ventricular pacing pulse Vp(F) may be interfered with by the fusion wave. On the other hand, the first ventricular pacing pulse Vp(F) may not be captured because it falls into the myocardial refractory period after the own ventricular excitation Vs. As shown at I, the first ventricular pacing pulse Vp(F) after the own ventricular excitation Vs cannot be captured because it falls into the myocardial refractory period. On the contrary, as shown at II, the second ventricular pacing pulse Vp(S) is captured because it is outside the refractory period; as shown at III, the first ventricular pacing pulse Vp(F) and the own ventricular excitation Vs form a fusion wave, causing the corresponding intracavitary electrocardiogram data to be interfered with. At this time, both the loss-of-capture accuracy and the capture accuracy may be significantly reduced, and a red or orange signal will be obtained after processing the intracavitary electrocardiogram data. When a red or orange signal appears, the user needs to be reminded by phone to go to the clinic for follow-up. If abnormal perception is confirmed, it should be treated in a timely manner to ensure that the pulse generator can work normally.

[0167] The early warning system and method for an implantable pulse generator provided in the embodiments of the present application actively judge the early warning level of the programmed parameter combination to determine whether the programmed parameter combination is the optimal preset parameter combination, thereby optimizing the pulse generator. This can improve the reliability of the implantable pulse generator, ensure the effectiveness of the pacing pulse, and only remind the user to go to the clinic for follow-up when necessary, thereby reducing on-site follow-up work.

Claims

1. An early warning system for an implantable pulse generator, characterized in that: include: An intracavitary electrocardiogram data acquisition module (100), a Bluetooth module (200), an intracavitary electrocardiogram data processing module (300), a signal indication module (400), and a pulse generator (500); The pulse generator (500) is used to deliver pacing pulses and collect raw intracavitary electrocardiogram data; The intracavitary electrocardiogram data acquisition module (100) is electrically connected to the pulse generator (500), and is used to read the program-controlled parameter combination in the pulse generator (500), and is also used to control the pulse generator (500) to acquire the original intracavitary electrocardiogram data, and pre-process the original intracavitary electrocardiogram data to obtain the intracavitary electrocardiogram data to be used; The Bluetooth module (200) is electrically connected to the intracavitary electrocardiogram data acquisition module (100) and is used to communicate with a mobile terminal; The intracavitary electrocardiogram data processing module (300) is used to obtain the capture accuracy rate and the loss-capture accuracy rate of the to-be-used intracavitary electrocardiogram data by a preset parameter combination, wherein the programmable parameter combination is a set of parameter combinations in the preset parameter combination; The signal indication module (400) is electrically connected to the intracavitary electrocardiogram data processing module (300), and is used to determine the warning level of the program-controlled parameter combination and display an operation indication corresponding to the warning level; The intracavitary electrocardiogram data processing module (300) comprises a third storage unit (312), a plurality of registers, a plurality of comparators and a plurality of counters; The registers include a first register (301), a second register (302), a third register (303) and a fourth register (305); The first register (301) is used to read the intracavitary electrocardiogram data to be used; The second register (302) is used to read the preset fluctuation value in the preset parameter combination; The third register (303) is used to store the preset critical value in the preset parameter combination; The comparator includes a first comparator (304), a second comparator (306) and a third comparator (307); The first comparator (304) is electrically connected to the first register (301) and the second register (302) respectively, and is used to determine whether each data point of the intracavitary electrocardiogram data to be used is outside the fluctuation range defined by the preset fluctuation value, and if the data point is outside the fluctuation range defined by the preset fluctuation value, the data point is a valid point; The fourth register (305) is used to store the accumulated calculated value of all valid points of a set of the to-be-used intracavitary electrocardiogram data; The second comparator (306) is electrically connected to the third register (303) and the fourth register (305) respectively, and is used to compare the accumulated calculation value with the preset critical value and output a corresponding comparison result, wherein the comparison result includes a capture determination and a loss of capture determination; The first input terminal of the third comparator (307) is electrically connected to the second comparator (306), and the second input terminal of the third comparator (307) inputs the theoretical result of the intracavitary electrocardiogram data to be used. The third comparator (307) is used to compare the comparison result with the theoretical result, and the theoretical result includes theoretical capture and theoretical loss of capture.

2. The early warning system for an implantable pulse generator according to claim 1, characterized in that: The counter includes a second counter (308), a third counter (309), a fourth counter (310) and a fifth counter (311) electrically connected to the third comparator (307) respectively; The second counter (308) is used to count once when the determined capture and the theoretical capture are input to the input end of the third comparator (307) at the same time; The third counter (309) is used to count once when the determined loss of capture and the theoretical loss of capture are simultaneously input to the input end of the third comparator (307); The fourth counter (310) is used to count once when the determined capture and the theoretical loss of capture are simultaneously input to the input end of the third comparator (307); The fifth counter (311) is used for counting once when the determined loss of capture and the theoretical capture are input to the input end of the third comparator (307) at the same time; The third storage unit (312) is used to store the capture accuracy rate and the loss-capture accuracy rate of the preset parameter combination; The signal indication module (400) comprises a fifth register (401), a sixth register (402), a seventh register (403), a fourth comparator (404) and a fifth comparator (405); The fifth register (401) is used to store a usage standard, wherein the usage standard is the minimum standard for the capture accuracy and the loss-capture accuracy of the preset parameter combination to meet the usage requirements, including the minimum capture accuracy and the minimum loss-capture accuracy; The sixth register (402) is electrically connected to the third storage unit (312) of the intracavitary electrocardiogram data processing module (300), and is used to read the program-controlled parameter combination from a database, and obtain the capture accuracy and loss-of-capture accuracy of the program-controlled parameter combination from the third storage unit (312); The seventh register (403) is electrically connected to the third storage unit (312) and is used to determine an alternative preset parameter combination, wherein the alternative preset parameter combination is a preset parameter combination with the highest capture accuracy and a corresponding loss of capture accuracy of 100%; The fourth comparator (404) is electrically connected to the fifth register (401) and the sixth register (402), respectively, and is used to compare the capture accuracy and loss-of-capture accuracy of the program-controlled parameter combination with the capture accuracy and loss-of-capture accuracy corresponding to the usage standard, and output a corresponding first operation instruction; The fifth comparator (405) is electrically connected to the fourth comparator (404) and the seventh register (403) respectively, and is used to compare the capture accuracy and loss-of-capture accuracy of the programmed parameter combination with the capture accuracy and loss-of-capture accuracy corresponding to the alternative preset parameter combination, and output a corresponding second operation instruction.

3. The early warning system for an implantable pulse generator according to claim 1, characterized in that: The intracavitary electrocardiogram data acquisition module (100) comprises: a timer (101), a first counter (102), a timer (103), an intracavitary electrocardiogram data preprocessing unit (104) and a first storage unit (105); The timer (101) is electrically connected to the pulse generator (500) and is used to trigger the intracavitary electrocardiogram data acquisition module (100) to start working through the pulse generator (500) at a first preset time; The first counter (102) is electrically connected to the pulse generator (500) and is used to record the number of groups of the collected original intracavitary electrocardiogram data, and trigger the Bluetooth module (200) to operate when the number of groups reaches a preset value; The timer (103) is electrically connected to the pulse generator (500) and is used to control the pulse generator (500) to collect two sets of original intracavitary electrocardiogram data after the first pulse and the second pulse within the preset collection area of the programmable parameter combination, and to trigger the pulse generator (500) to release a pacing pulse at a second preset time; The intracavitary electrocardiogram data preprocessing unit (104) is electrically connected to the pulse generator (500) and is used to preprocess the original intracavitary electrocardiogram data to obtain the to-be-used intracavitary electrocardiogram data; The first storage unit (105) is electrically connected to the intracavitary electrocardiogram data preprocessing unit (104), and is used to store the standby intracavitary electrocardiogram data, and is also used to read and store the program-controlled parameter combination from the pulse generator (500).

4. An early warning method for an implantable pulse generator, characterized in that: The method is applied to the early warning system for an implantable pulse generator according to claim 1, comprising the following steps: S1: The second register (302) obtains a preset fluctuation value of a preset parameter combination; S2: The third register (303) obtains a set of preset critical values of the preset parameter combination; S3: The first register (301) obtains a set of intracavitary electrocardiogram data to be used; S4: If the intracavitary electrocardiogram data to be used corresponds to the first pacing pulse, a high level is input to the second input terminal of the third comparator (307), indicating that the theoretical state of the intracavitary electrocardiogram data to be used is theoretical capture; If the pair of intracavitary electrocardiogram data to be used corresponds to the second pacing pulse, a low level is input to the second input terminal of the third comparator (307), indicating that the theoretical state of the intracavitary electrocardiogram data to be used is theoretical loss of capture; S5: Reading a data point of the to-be-used intracavitary electrocardiogram data from the first register (301); S6: If the data point is outside the fluctuation range defined by the preset fluctuation value stored in the second register (302), the data point is a valid point and the process proceeds to S7; otherwise, the data point is an invalid point and the process proceeds to S8; S7: adding the calculated value of the data point to the calculated value of the previous data point to obtain an accumulated calculated value, storing the accumulated calculated value in the fourth register (305), and proceeding to S8; S8: If the data point is the last data point of the to-be-used intracavitary electrocardiogram data, proceed to S9; otherwise, read the next data point of the to-be-used intracavitary electrocardiogram data and proceed to S6; S9: If the accumulated calculated value in the fourth register (305) is greater than the preset critical value in the third register (303), the second comparator (306) inputs a high level to the first input terminal of the third comparator (307), indicating that the preset parameter combination determines that the state of the standby intracavitary electrocardiogram data is captured; Otherwise, the second comparator (306) inputs a low level to the first input terminal of the third comparator (307), indicating that the preset parameter combination determines that the state of the standby intracavitary electrocardiogram data is loss of capture; S10: If the first input terminal and the second input terminal of the third comparator (307) are both at a high level, the second counter (308) performs one count; If the first input terminal and the second input terminal of the third comparator (307) are both at a low level, the third counter (309) performs one count; If the first input terminal of the third comparator (307) is at a high level and the second input terminal is at a low level, the fourth counter (310) counts once; If the first input terminal of the third comparator (307) is at a low level and the second input terminal is at a high level, the fifth counter (311) counts once; S11: If the standby intracavitary electrocardiogram data in the first register (301) is not the last set of standby intracavitary electrocardiogram data, proceed to S12; otherwise, proceed to S13; S12: the first register (301) obtains the next set of intracavitary electrocardiogram data to be used, and proceeds to S4; S13: determining the capture accuracy rate and the loss-of-capture accuracy rate of the preset parameter combination according to the counting results of the second counter (308), the third counter (309), the fourth counter (310), and the fifth counter (311), and saving the capture accuracy rate and the loss-of-capture accuracy rate of the preset parameter combination to a third storage unit (312); S14: Clearing the data in the fourth register (305), the second counter (308), the third counter (309), the fourth counter (310) and the fifth counter (311); S15: If the preset critical value obtained by the third register (303) is not the preset critical value of the last set of preset parameter combinations, the third register (303) obtains the preset critical value of the next set of preset parameter combinations and performs S3, otherwise the preset parameter combination processing is completed.

5. The early warning method for an implantable pulse generator according to claim 4, characterized in that: The following steps are involved: Acquiring original intracavitary electrocardiogram data and a program-controlled parameter combination, wherein the program-controlled parameter combination is a parameter used in a pulse generator; Preprocessing the original intracavitary electrocardiogram data to obtain the intercavitary electrocardiogram data to be used; Determining theoretical results of the to-be-used intracavitary electrocardiogram data, wherein the theoretical results include theoretical capture and theoretical loss of capture; Determine the capture accuracy and loss-of-capture accuracy of the to-be-used intracavitary electrocardiogram data by a preset parameter combination, wherein the programmable parameter combination is a set of parameter combinations in the preset parameter combination; Determining an early warning level of the program-controlled parameter combination according to a usage standard and the capture accuracy rate and the loss-of-capture accuracy rate of the preset parameter combination, wherein the usage standard is that the capture accuracy rate and the loss-of-capture accuracy rate of the preset parameter combination meet a minimum standard of usage requirements, including a minimum capture accuracy rate and a minimum loss-of-capture accuracy rate; Determining the warning level of the program-controlled parameter combination according to the usage standard and the capture accuracy rate and the loss-of-capture accuracy rate of the preset parameter combination comprises the following steps: S1: Obtaining the minimum capture accuracy and the minimum loss of capture accuracy of the usage standard; S2: Obtaining the capture accuracy and the loss-capture accuracy of the preset parameter combination; S3: determining an alternative preset parameter combination, wherein the alternative preset parameter combination is a preset parameter combination having the highest capture accuracy among all the preset parameter combinations and a corresponding loss of capture accuracy of 100%; S4: comparing the loss-of-capture accuracy of the program-controlled parameter combination with the minimum loss-of-capture accuracy; if the loss-of-capture accuracy of the program-controlled parameter combination is inconsistent with the minimum loss-of-capture accuracy, the warning level of the program-controlled parameter combination is level 1; otherwise, proceed to S5; S5: comparing the capture accuracy of the program-controlled parameter combination with the minimum capture accuracy; if the capture accuracy of the program-controlled parameter combination is less than the minimum capture accuracy, the warning level of the program-controlled parameter combination is level 2; otherwise, proceed to S6; S6: comparing the capture accuracy of the program-controlled parameter combination with the capture accuracy of the alternative preset parameter combination; if the capture accuracy of the program-controlled parameter combination is lower than the capture accuracy of the alternative preset parameter combination, the warning level of the program-controlled parameter combination is level 3; otherwise, proceed to S7; S7: Evaluate two sets of preset parameter combinations adjacent to the programmed parameter combination based on the alternative preset parameter combination, the two sets of preset parameter combinations being preset parameter combinations whose preset critical values are adjacent to the preset critical value of the programmed parameter combination, and whose preset critical value is an intermediate value. If the capture accuracy rates of the two sets of preset parameter combinations are consistent with the capture accuracy rate of the alternative preset parameter combination, and the loss-of-capture accuracy rates of the two sets of preset parameter combinations are consistent with the loss-of-capture accuracy rate of the alternative preset parameter combination, then the warning level of the programmed parameter combination is level five; otherwise, the warning level of the programmed parameter combination is level four.

6. The early warning method for an implantable pulse generator according to claim 5, characterized in that: The capture accuracy rate and the loss capture accuracy rate are calculated by the following formulas:

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