A pacing frequency adaptive adjustment device and a cardiac pacing device with automatic parameter optimization

Abstract

The application discloses a parameter automatic optimization pacing frequency self-adaptive adjusting device and a cardiac pacing device, which comprises an acceleration signal acquisition module, a motion amount evaluation and statistics module, a target heart rate calculation and statistics module, a pacing frequency adjusting and statistics module and a parameter automatic optimization module; the target heart rate value is determined through the motion amount evaluation value, the pacing frequency value at the next moment is determined through the size relation between the target heart rate value and the actual heart rate value and the selection of the time-pacing frequency rising / falling curve, the pacing related parameters are automatically optimized and adjusted, so that the program control setting of the frequency self-adaptive adjusting function is simplified, the function always works in the best parameter state, and the daily life quality is improved; after the daily life state changes, the pacing related parameters are also automatically optimized and adjusted, so that the needs of different dynamic changes can be met; after the upper and lower limit motion amounts are automatically optimized, the motion amount-target heart rate curve can adopt multiple adjustment strategies, and the personalized needs of different patients can be met.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to a pacing frequency adaptive adjustment device with automatic parameter optimization and a cardiac pacing device. Background Technology

[0002] A cardiac pacemaker stimulates the heart by sending electrical pulses to restore its normal electrical activity. For pacemakers, adaptive pacing rate is a crucial function designed to provide sufficient cardiac output to pacemaker patients under varying metabolic demands. Adaptive pacing rate can significantly compensate for symptoms of chronotropic cardiac dysfunction and greatly improve the exercise tolerance of pacemaker patients. Currently, clinically applied adaptive pacing schemes are mainly based on minute ventilation, closed-loop stimulation, or accelerometers. Accelerometers, which adjust the pacing rate based on the acceleration signal of human movement, are the most widely used sensors in pacemakers. Their advantages include good long-term stability and high sensitivity; their disadvantages include poor specificity and inability to directly sense changes in physiological state.

[0003] Adaptive pacing frequency adjustment using an accelerometer involves the following steps: assessing exercise intensity based on acceleration signals; calculating the target heart rate based on exercise intensity; and gradually transitioning from the current heart rate to the target heart rate according to a specific strategy, based on the relative relationship between the target heart rate and the current pacing frequency. The programmable parameters related to adaptive pacing include at least the following six items: lower limit sensor frequency, upper limit sensor frequency, exercise intensity threshold, target heart rate slope, pacing frequency rise time, and pacing frequency fall time. Specifically, the lower limit sensor frequency determines the lowest pacing frequency a patient can achieve at rest; the upper limit sensor frequency determines the maximum pacing frequency a patient can achieve during strenuous exercise; the exercise intensity threshold determines the minimum exercise intensity required to trigger an increase in heart rate; the target heart rate slope determines the rate of heart rate change under different exercise intensities; the pacing frequency rise time determines the time required for the pacing frequency to rise from the lower limit sensor frequency to the upper limit sensor frequency when the patient begins high-intensity exercise; and the pacing frequency fall time determines the time required for the pacing frequency to fall from the upper limit sensor frequency back to the lower limit sensor frequency after high-intensity exercise at rest.

[0004] To meet the needs of different patients, doctors usually manually set or adjust the relevant parameters of frequency adaptive pacing during follow-up. However, manual setting has the following problems: (1) Doctors usually determine the relevant parameters based on personal experience and patient inquiries, which leads to a great deal of subjectivity and uncertainty in parameter setting, making it difficult to make the pacemaker work in the optimal parameter state; (2) When setting parameters, doctors can only select a fixed set of parameters from a limited range of levels, which cannot meet the personalized needs of all patients; (3) Doctors can only set parameters based on the patient's current physical condition and activity level during follow-up, but the patient's daily life status is constantly changing, and fixed parameters cannot meet the patient's real-time dynamic needs; (4) The patient follow-up period is usually several months to a year. During the follow-up period, the patient's physical condition and daily activity status may change significantly. If the relevant parameters are not adjusted in time, it may affect the patient's quality of life. In addition, given that the process of configuring and optimizing frequency adaptive pacing parameters is cumbersome and time-consuming, in clinical practice, many patients who have been implanted with frequency adaptive pacemakers still have their pacing parameters set at the factory (default parameters) without adjustment. This practice is obviously not patient-friendly. Summary of the Invention

[0005] In view of the limitations of manually setting or adjusting relevant parameters in the aforementioned frequency adaptive pacemaker using an accelerometer, the present invention provides a pacing frequency adaptive adjustment device and a cardiac pacing device with automatic parameter optimization to achieve automatic optimization of relevant parameters.

[0006] In a first aspect, the embodiment provides a pacing frequency adaptive adjustment device with automatic parameter optimization, including an acceleration signal acquisition module, an exercise volume assessment and statistics module, a target heart rate calculation and statistics module, a pacing frequency adjustment and statistics module, and an automatic parameter optimization module;

[0007] The acceleration signal acquisition module is used to convert the patient's physical activity signals acquired by the acceleration sensor into acceleration signals;

[0008] The exercise volume assessment and statistics module is used to assess the patient's exercise volume based on the collected acceleration signal using the threshold comparison method to obtain the exercise volume assessment value, and to statistically analyze the distribution of the acceleration signal within different acceleration threshold ranges within a preset period, as well as the distribution of the exercise volume assessment value within different exercise volume ranges within a preset period.

[0009] The target heart rate calculation and statistics module is used to determine the target heart rate value that should be achieved by the exercise volume assessment value according to the exercise volume-target heart rate curve, and to statistically analyze the distribution of the target heart rate value in different heart rate ranges within a preset period.

[0010] The pacing frequency adjustment and statistics module is used to select the time-pacing frequency rise / fall curve to determine the pacing frequency value at the next moment based on the relationship between the target heart rate value and the actual heart rate value, and to statistically analyze the distribution of the pacing frequency value in different heart rate ranges within a preset period.

[0011] The automatic parameter optimization module is used to automatically optimize and adjust the following parameters based on the statistical distribution of acceleration signals, exercise volume assessment values, target heart rate values, and pacing frequency values: relative acceleration threshold, lower limit exercise volume, upper limit exercise volume, lower limit pacing frequency, upper limit pacing frequency, and rise and fall times of pacing frequency.

[0012] Secondly, an embodiment provides a cardiac pacing device, characterized in that it includes:

[0013] The pacing rate adaptive adjustment device with automatically optimized parameters as described in the first aspect;

[0014] The pacing control unit is communicatively connected to the pacing frequency adaptive adjustment device and is used to send cardiac pacing events, i.e. cardiac pacing pulse signals, according to the cardiac pacing frequency output by the pacing frequency adaptive adjustment device.

[0015] The technical solutions provided in the above embodiments have at least the following beneficial effects:

[0016] The adaptive pacing frequency adjustment device provided in this embodiment determines a target heart rate value based on exercise volume assessment values. It then selects a time-pacing frequency rise / fall curve based on the relationship between the target heart rate value and the actual heart rate value to determine the pacing frequency value for the next moment. Simultaneously, it automatically optimizes and adjusts pacing-related parameters based on the statistical distribution of acceleration signals, exercise volume assessment values, target heart rate values, and pacing frequency values. This simplifies the programming settings of the adaptive frequency adjustment function and ensures that the function always operates at optimal parameter levels, improving the patient's quality of life. When the patient's daily life changes, the pacing-related parameters are also automatically optimized and adjusted to meet the needs of different dynamic changes. After automatic optimization of the upper and lower limits of exercise volume, the exercise volume-target heart rate curve can employ various adjustment strategies to meet the personalized needs of different patients.

[0017] The cardiac pacing device provided in this embodiment employs a pacing frequency adaptive adjustment device that can output a suitable cardiac pacing frequency and send cardiac pacing pulse signals according to the cardiac pacing frequency, thereby improving pacing effect and ensuring life safety. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of the structure of an adaptive pacing frequency adjustment device with automatic parameter optimization provided in one embodiment;

[0020] Figure 2 This is a flowchart illustrating the exercise volume assessment and related parameter statistics provided in one embodiment;

[0021] Figure 3 This is a flowchart of pacing rate adjustment and related parameter statistics provided in one embodiment;

[0022] Figure 4 This is a schematic diagram of acceleration signal acquisition provided in an embodiment, wherein (a), (b) and (c) are schematic diagrams of acceleration signal acquisition when the relative acceleration threshold is too large, the threshold is too small and the threshold is moderate, respectively;

[0023] Figure 5 This is a schematic diagram of the exercise volume-target heart rate curve provided in one embodiment, wherein (a), (b) and (c) are schematic diagrams of the exercise volume-target heart rate curve corresponding to three automatic optimization schemes for lower limit exercise volume, respectively;

[0024] Figure 6 This is a schematic diagram of the exercise volume-target heart rate curve provided in one embodiment, wherein (a), (b) and (c) are schematic diagrams of the exercise volume-target heart rate curves corresponding to three automatic optimization schemes for the upper limit of exercise volume, respectively;

[0025] Figure 7 This is a schematic diagram of the time-pacing rate rise curve provided in one embodiment, wherein (a) and (b) are schematic diagrams of the linear time-pacing rate rise curve and the exponential time-pacing rate rise curve with automatic rise time optimization, respectively.

[0026] Figure 8 This is a schematic diagram of the time-pacing rate decline curve provided in one embodiment, wherein (a) and (b) are schematic diagrams of the linear time-pacing rate decline curve and the exponential time-pacing rate decline curve with automatic optimization of decline time, respectively.

[0027] Figure 9 This is a schematic diagram of the cardiac pacing device provided in an embodiment of the present invention. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and do not limit the scope of protection of this invention.

[0029] To address the limitations of manually setting or adjusting parameters in frequency-adaptive pacemakers using accelerometers, this invention provides an automatically optimized pacing frequency adaptive adjustment device and a cardiac pacing device, belonging to the field of implantable medical devices.

[0030] Figure 1 This is a schematic diagram of the pacing rate adaptive adjustment device with automatic parameter optimization provided in an embodiment of the present invention. Figure 1 As shown, the adaptive adjustment device 100 provided in the embodiment includes an acceleration signal acquisition module 101, an exercise volume assessment and statistics module 102, a target heart rate calculation and statistics module 103, a pacing frequency adjustment and statistics module 104, and a parameter automatic optimization module 105. The acceleration signal acquisition module 101 is communicatively connected to the exercise volume assessment and statistics module 102, the exercise volume assessment and statistics module 102 is communicatively connected to the target heart rate calculation and statistics module 103, the target heart rate calculation and statistics module 103 is communicatively connected to the pacing frequency adjustment and statistics module 104, and the pacing frequency adjustment and statistics module 104 is communicatively connected to the parameter automatic optimization module 105.

[0031] The acceleration signal acquisition module 101 converts the patient's body activity signals acquired by the acceleration sensor into acceleration signals; the exercise volume assessment and statistics module 102 uses a threshold comparison method to assess the patient's exercise volume based on the acquired acceleration signals to obtain an exercise volume assessment value, and statistically analyzes the distribution of acceleration signals within different acceleration threshold ranges within a preset period, as well as the distribution of exercise volume assessment values ​​within different exercise volume ranges within a preset period; the target heart rate calculation and statistics module 103 determines the target heart rate value that should be achieved based on the exercise volume-target heart rate curve, and statistically analyzes the target heart rate value within a preset period. The distribution of heart rate values ​​within the same heart rate interval; the pacing frequency adjustment and statistics module 104 is used to determine the pacing frequency value at the next moment by selecting the time-pacing frequency rise / fall curve based on the relationship between the target heart rate value and the actual heart rate value, and to statistically analyze the distribution of pacing frequency values ​​within different heart rate intervals within a preset period; the automatic parameter optimization module 105 is used to automatically optimize and adjust pacing-related parameters based on the statistical distribution of acceleration signals, exercise volume assessment values, target heart rate values, and pacing frequency values: relative acceleration threshold, lower limit exercise volume, upper limit exercise volume, lower limit pacing frequency, upper limit pacing frequency, and the rise and fall times of pacing frequency.

[0032] In its specific implementation, the acceleration signal acquisition module 101 uses an accelerometer to collect body activity signals and converts them into analog acceleration signals. These analog acceleration signals undergo preprocessing such as modulation, amplification, phase-sensitive demodulation, anti-aliasing filtering, and analog-to-digital conversion before being converted into digital acceleration signals, simply referred to as acceleration signals. In this embodiment, the accelerometer can be a 3-axis capacitive MEMS accelerometer. Considering the characteristics of human motion acceleration, the amplitude detection range is set to ±2g. The analog-to-digital converter uses a 10-bit resolution. Considering that the main frequency of acceleration during daily human activities is usually below 4Hz, the sampling rate of the accelerometer is fixed at 10Hz, i.e., the sampling interval Δn is 100ms.

[0033] In its specific implementation, the exercise volume assessment and statistics module 102 calculates the relative acceleration value of the main axis based on the acceleration signal at each sampling moment, compares the relative acceleration value of the main axis with multiple set relative acceleration thresholds, and calculates the proportion of the relative acceleration value of the main axis in each relative acceleration threshold interval to obtain the distribution of the acceleration signal in different acceleration threshold intervals within a preset period. The relative acceleration value of the main axis located in different relative acceleration threshold intervals corresponds to different weights of exercise volume scores. The sum of the exercise volume scores at all sampling moments within a period of time is used as the exercise volume assessment value at the current moment. Based on the equal division interval of the maximum exercise volume, the proportion of the exercise volume assessment value in each equal division interval within a preset period is calculated to obtain the distribution of the exercise volume assessment value in different exercise volume intervals.

[0034] Figure 2 This is a flowchart illustrating the exercise volume assessment and related parameter statistics provided in one embodiment. For example... Figure 2As shown, in this embodiment, a three-axis acceleration sensor is adopted to obtain the acceleration sampling values Ai(n) of each axis at time n, where i = x, y, z, respectively representing the three single axes of x, y, and z. The absolute value of the difference between the acceleration sampling values of each axis at two adjacent sampling times is used as the relative acceleration of each axis, and the axis with the maximum relative acceleration is taken as the main axis. That is, the relative acceleration of the main axis at the current time n is J(n) = max(|Ai(n) - Ai(n - 1)|). Three gears of relative acceleration thresholds Tj1, Tj2, and Tj3 are preset, and Tj1 < Tj2 < Tj3. The percentages of J(n) in the intervals [0, Tj1), [Tj1, Tj2), [Tj2, Tj3), and [Tj3, +∞) within the time range t1 before the current time are updated in real time. When the relative acceleration J(n) of the main axis belongs to the interval [0, Tj1), the corresponding motion score value S(n) = s1; when J(n) belongs to the interval [Tj1, Tj2), the corresponding motion score value S(n) = s2; when J(n) belongs to the interval [Tj2, Tj3), the corresponding motion score value S(n) = s3; when J(n) belongs to the interval [Tj3, +∞), the corresponding motion score value S(n) = s4. If the current is the exercise amount evaluation time N, then the sum of the motion score values S(k) at all sampling times within the time range t0 before the current time with the current time as the end point is used as the exercise amount evaluation value M(N) at the current time, that is The total exercise amount interval range [0, Mmax] is equally divided into 10 sub-intervals, where Mmax is the maximum exercise amount. The proportion of M(N) in each interval within the time range t2 before the current time is updated in real time. Thus, an exercise amount evaluation process is completed, and the distribution of the exercise amount evaluation value in different exercise amount interval ranges is obtained, and it waits for the arrival of the next sampling time. In a specific embodiment, the preset multi-gear relative acceleration thresholds are in a multiple relationship, Tj1 = 140mg, Tj2 = 2 × Tj1 = 280mg, Tj3 = 4 × Tj1 = 560mg, where the adjustable range of Tj1 is [80, 200mg]; s1 = 0, s2 = 1, s3 = 2, and s4 = 4 are preset as the motion score values; the exercise amount evaluation duration t0 is 6 seconds. Since the sampling rate is 10Hz, M(N) is the sum of the motion score values at 60 sampling times before the current exercise amount evaluation time, and the maximum value of the upper limit exercise amount Mmax can be calculated to be 240; the preset statistical period t1 of the acceleration is 1 day; the preset short-term statistical period t2 of the exercise amount is 1 day, and the long-term statistical period t3 is 7 days. The above preset parameter values are for illustrative purposes only and can be set according to requirements in actual applications.

[0035] In the specific implementation of the target heart rate calculation and statistics module 103, a lower limit exercise volume Mmin is preset. When the exercise volume assessment value at the current moment is less than the lower limit exercise volume, it is determined that the current moment is in a resting state, and the target heart rate corresponding to the resting state is the lower limit pacing frequency. When the exercise volume assessment value at the current moment is not less than the lower limit exercise volume Mmin, it is determined that the current moment is in an exercise state, and the target heart rate corresponding to the exercise state is calculated based on the exercise volume assessment value M(N) at the current moment, the lower limit exercise volume Mmin, the upper limit exercise volume Mmax, the lower limit pacing frequency HRmin, and the upper limit pacing frequency HRmax. Preferably, the target heart rate TR(N) = (HRmax - HRmin) / (Mmax ​​- Mmin) × (M(N) - Mmin) + HRmin. After determining the target heart rate value at each sampling moment, the proportion of the target heart rate value in each equally divided interval within the preset period is statistically analyzed according to the equally divided interval [HRmin, HRmax] to obtain the distribution of the target heart rate value in different heart rate intervals.

[0036] In its specific implementation, the pacing rate adjustment and statistics module 104 determines the pacing rate value at the next moment by using the time-pacing rate rising curve when the current actual heart rate value is less than or equal to the target heart rate value; and determines the pacing rate value at the next moment by using the time-pacing rate falling curve when the current actual heart rate value is greater than the target heart rate value. Based on the equal division of the interval [HRmin, HRmax], it statistically analyzes the proportion of the pacing rate value in each equal division interval within the preset period to obtain the distribution of the pacing rate value in different heart rate intervals.

[0037] Figure 3 This is a flowchart illustrating the pacing rate adjustment and related parameter statistics provided in one embodiment; as follows: Figure 3As shown, at time N after a fixed time interval ΔN, the patient's current exercise volume assessment value M(N) is obtained. The target heart rate TR(N) is calculated using the exercise volume-target heart rate curve. The value range of TR(N) [HRmin, HRmax] is divided into 10 sub-intervals, and the proportion of TR(N) in each interval within the time range t3 before the current time is updated in real time. Then, the current actual heart rate HR(N) and the target heart rate TR(N) are compared. If HR(N) ≤ TR(N), the pacing frequency PR(N) for the next time moment is determined by the time-pacing frequency rising curve. If HR(N) > TR(N), the pacing frequency PR(N) for the next time moment is determined by the time-pacing frequency falling curve. The value range of PR(N) [HRmin, HRmax] is divided into 10 sub-intervals, and the proportion of pacing frequency PR(N) in each interval within the time range t4 before the current time moment is updated in real time. This completes one pacing frequency adjustment and waits for the next pacing frequency update. In this specific embodiment, the lower limit exercise intensity Mmin is set to 20, the upper limit exercise intensity Mmax is set to 240, the upper limit pacing frequency HRmax is set to 160 bpm, and the lower limit pacing frequency HRmin is set to 60 bpm; the pacing frequency update interval ΔN is set to 2 seconds; the preset statistical period t4 for TR(N) is 7 days; and the preset statistical period t5 for PR(N) is 7 days. The parameter values ​​provided are illustrative examples and can be set according to actual needs in practical applications.

[0038] In this embodiment, the time-pacing rate rise curve indicates the process of heart rate rising from HRmin to HRmax. The pacing rate can increase with time according to a linear or exponential function. Therefore, the time-pacing rate rise curve is a linear function curve or an exponential function curve, where the exponential function is more physiological. In this embodiment, the preset total rise time Inc can be 30 seconds. The time-pacing rate fall curve indicates the process of heart rate falling from HRmax to HRmin. The pacing rate can decrease with time according to a linear or exponential function. Therefore, the time-pacing rate fall curve is a linear function curve or an exponential function curve, where the exponential function is more physiological. In this specific embodiment, the preset total fall time Dec is 5 minutes.

[0039] In the automatic parameter optimization module 105, the automatic optimization and adjustment process of the relative acceleration threshold includes:

[0040] Based on the distribution of acceleration signals within different acceleration threshold ranges within the latest preset period t1, the system judges whether the current relative acceleration threshold setting is reasonable according to the preset discrimination criteria. If the threshold setting is too high, the acceleration threshold for each level will be reduced by a certain amount. If the threshold setting is too low, the acceleration threshold for each level will be increased by a certain amount. If the threshold setting is reasonable, it will remain unchanged.

[0041] In this embodiment, the proportions of relative acceleration within the intervals [0,Tj1), [Tj1,Tj2), [Tj2,Tj3), and [Tj3,+∞) are set as Pj1, Pj2, Pj3, and Pj4, respectively. Two preset discrimination standards are set at 25% and 50%, respectively. If Pj4 / Pj3 < 25%, the threshold is considered too high. Figure 4 As shown in (a), 20 mg, 40 mg, and 80 mg are subtracted from Tj1, Tj2, and Tj3, respectively; if Pj4 / Pj3 > 50%, the threshold is considered too low. Figure 4 As shown in (b), 20 mg, 40 mg, and 80 mg are added to Tj1, Tj2, and Tj3 respectively; if 25% ≤ Pj4 / Pj3 ≤ 50%, the threshold is considered reasonable. Figure 4 As shown in (c), Tj1, Tj2, and Tj3 remain unchanged. The preset discrimination criteria and threshold adjustment amounts in this process are for illustrative purposes only; in actual applications, they can be set according to requirements.

[0042] In the parameter automatic optimization module 105, the automatic optimization and adjustment process of the lower limit exercise volume includes:

[0043] The system presets daily exercise volume. Based on the distribution of exercise volume assessment values ​​within different exercise volume ranges in the latest preset period t2, it analyzes the first proportion of exercise volume within the range of [lower limit exercise volume Mmin, daily exercise volume Mdaily] to determine whether the current lower limit exercise volume setting is reasonable. If the first proportion is greater than the set upper limit value, the lower limit exercise volume setting is considered too low, and the lower limit exercise volume is increased by a certain amount. If the first proportion is less than the set lower limit value, the lower limit exercise volume setting is considered too high, and the lower limit exercise volume is decreased by a certain amount. If the first proportion is within the range of the set lower limit value and the set upper limit value, the current lower limit exercise volume setting is considered reasonable, and the lower limit exercise volume remains unchanged. During the adjustment process, it is ensured that the lower limit exercise volume does not exceed the settable range. In this embodiment, Mdaily is set to 80; the reasonable percentage of exercise within the range [Mmin, Mdaily] is 10%-25%, i.e., the lower and upper limits of the first percentage are set to 10% and 25% respectively; if the first percentage is lower than 10%, the current Mmin setting is considered too high, and Mmin is reduced by 2; if the first percentage is higher than 25%, the current Mmin setting is considered too low, and Mmin is increased by 2; the value range of Mmin is [10, 30]. In this process, the preset value of Mdaily, the adjustment amount of Mmin, and the setting of the lower and upper limits of the first percentage are all illustrative examples. In actual applications, they can be set according to requirements.

[0044] In the parameter automatic optimization module 105, the automatic optimization and adjustment process of the upper limit of exercise volume includes:

[0045] Based on the distribution of exercise volume assessment values ​​within different exercise volume ranges within the latest preset period t3, the second proportion of exercise volume within the range of [daily exercise volume Mdaily, maximum exercise volume Mmax] is analyzed to determine whether the current maximum exercise volume setting is reasonable. If the second proportion is greater than the set upper limit value, the maximum exercise volume is considered too high, and the maximum exercise volume is reduced by a certain amount; if the second proportion is less than the set lower limit value, the maximum exercise volume is considered too low, and the maximum exercise volume is increased by a certain amount; if the second proportion is within the range of the set lower limit value and the set upper limit value, the current setting is considered reasonable, and the maximum exercise volume remains unchanged; during the adjustment process, it is ensured that the maximum exercise volume does not exceed the settable range. In this embodiment, the reasonable percentage of exercise within the range of [Mdaily, Mmax] in the total exercise is 5%-15%, i.e., the lower limit and upper limit of the second ratio are 5% and 15%, respectively. If the second ratio is lower than 5%, the current Mmax setting is considered too low, and Mmax is increased by 4; if the second ratio is higher than 15%, the current Mmax setting is considered too high, and Mmax is decreased by 4. The value range of Mmax is [200, 240]. In this process, the preset value of Mdaily, the adjustment amount of Mmax, and the setting of the lower and upper limits of the second ratio are all illustrative examples. In actual applications, they can be set according to requirements.

[0046] In the parameter automatic optimization module 105, after the lower limit of exercise volume is automatically optimized and adjusted, the optional adjustment strategies for the exercise volume-target heart rate curve include: keeping the upper limit of exercise volume unchanged, and adjusting the overall slope of the curve, such as... Figure 5 As shown in (a); or keep the preset daily exercise volume unchanged, and only adjust the slope of the curve for the portion of the daily exercise volume that is less than the preset daily exercise volume, such as Figure 5 As shown in (b); or keep the slope of the curve unchanged, only shift the portion of the curve that is less than the daily exercise volume, such as... Figure 5 As shown in (c). In actual use, one of the adjustment strategies should be selected and programmed by the doctor according to the patient's actual needs.

[0047] In the parameter automatic optimization module 105, after the automatic optimization and adjustment of the upper limit of exercise volume, the optional adjustment strategies for the exercise volume-target heart rate curve include: keeping the lower limit of exercise volume unchanged, and adjusting the overall slope of the curve, such as... Figure 6 As shown in (a); or keep the preset daily exercise volume unchanged, and only adjust the slope of the curve for the portion exceeding the daily exercise volume, such as... Figure 6 As shown in (b); or keep the slope of the curve constant, only shift the portion of the curve that exceeds the daily exercise volume, such as... Figure 6 As shown in (c). In actual use, one of the adjustment strategies should be selected and programmed by the doctor according to the patient's actual needs.

[0048] In the automatic parameter optimization module 105, the automatic optimization and adjustment process of the lower limit pacing rate includes:

[0049] The resting state is divided into sleep state, daily rest state, and post-exercise rest state. The lower limit pacing frequency HRmin takes different values ​​in different states. If the current period is sleep and the rest duration exceeds the preset first duration (e.g., 1 hour), it is determined to be in sleep state, and the lower limit pacing frequency is reduced by a certain amount, for example, HRmin = HRmin(preset value) - 10 = 50 beats / minute, where HRmin(preset value) is preset to 60 beats / minute. If the current period is not sleep and the rest duration exceeds the preset second duration (e.g., 1 hour), it is determined to be in daily rest state, and the lower limit pacing frequency remains unchanged, i.e., HRmin = HRmin(preset value) = 60 beats / minute. If the current continuous rest duration is less than the preset third duration (e.g., 1 hour), it is determined to be in post-exercise rest state, and the lower limit pacing frequency is increased by a certain amount, for example, HRmin = HRmin(preset value) + 10 = 70 beats / minute.

[0050] In the automatic parameter optimization module 105, the automatic optimization and adjustment process of the upper limit pacing rate includes:

[0051] Based on the distribution of the target heart rate value within different heart rate intervals within the latest preset period t4, the third proportion of the target heart rate value within the interval [α × upper limit pacing frequency HRmax, upper limit pacing frequency HRmax] to the total heart rate is analyzed. If the third proportion is greater than the set upper limit value of the third proportion, it is determined that the upper limit pacing frequency is set too low, and the upper limit pacing frequency is increased by a certain amount; if the third proportion is less than the set lower limit value of the third proportion, it is determined that the upper limit pacing frequency is set too high, and the upper limit pacing frequency is decreased by a certain amount; if the third proportion is within the range of the set lower limit value and the upper limit value of the third proportion, it is determined that the current setting is reasonable, and the upper limit pacing frequency remains unchanged; during the adjustment process, it is ensured that the upper limit pacing frequency does not exceed the settable range. In this embodiment, α is a preset value less than 1. Preferably, the value of α ranges from 0.80 to 0.95, and specifically, the preferred value is 0.90. The reasonable proportion of the target heart rate value in the total heart rate within the range of [α×HRmax, HRmax] is 2.5%-5%, that is, the lower limit and upper limit of the third proportion are set to 2.5% and 5% respectively. If the third proportion is greater than 5%, HRmax is increased by 5 beats / minute; if the third proportion is less than 2.5%, HRmax is decreased by 5 beats / minute. The value range of HRmax is [HRmax(preset value)-10, HRmax(preset value)+10], which is [150, 170] in this example. In this process, the adjustment amount of HRmax and the setting of the lower limit and upper limit of the third proportion are for illustrative purposes only. In actual applications, they can be set according to requirements.

[0052] In the automatic parameter optimization module 105, the automatic optimization and adjustment process of the rise time of the pacing rate includes:

[0053] Based on the distribution of the target heart rate value within different heart rate intervals within the latest preset period t4 and the distribution of the pacing frequency value within different heart rate intervals within the preset period t5, the fourth proportion of the pacing frequency value within the range of [β × upper limit pacing frequency HRmax, upper limit pacing frequency HRmax] and the fifth proportion of the target heart rate within this range to the total target heart rate are obtained. Let the sixth proportion = fourth proportion / fifth proportion. If the sixth proportion is greater than the set upper limit of the sixth proportion, it is determined that the rise time is too fast, and the rise time is increased by a certain amount; if the sixth proportion is less than the set lower limit of the sixth proportion, it is determined that the rise time is too slow, and the rise time is decreased by a certain amount; if the sixth proportion is within the range of the set lower and upper limits of the sixth proportion, it is determined that the current setting is appropriate, and the rise time does not remain unchanged; during the adjustment process, it is ensured that the rise time does not exceed the selectable value range. In this embodiment, β is a preset value less than 1. Preferably, the value of β ranges from 0.80 to 0.95, with a specific preferred value of 0.90. The reasonable proportion range of the sixth ratio within the range of [β×HRmax, HRmax] is 25%-75%, that is, the lower limit and upper limit of the sixth ratio are 25% and 75% respectively. If the sixth ratio is greater than 75%, it is determined that the rise time is too fast, and the rise time Inc is increased by 5 seconds; if the sixth ratio is less than 25%, it is determined that the rise time is too slow, and Inc is decreased by 5 seconds. The selectable value range of Inc is [15, 60] seconds. In this process, the adjustment amount of Inc and the setting of the lower and upper limits of the sixth ratio are for illustrative purposes only. In actual applications, they can be set according to requirements. The time-pacing rate rise curve before and after Inc adjustment is shown in the figure. Figure 7 As shown.

[0054] In the automatic parameter optimization module 105, the automatic optimization and adjustment process of the pacing rate fall time includes:

[0055] Based on the distribution of the target heart rate value within different heart rate intervals within the latest preset period t4 and the distribution of the pacing frequency value within different heart rate intervals within the preset period t5, the seventh proportion of the pacing frequency value within the interval [γ×lower limit pacing frequency, δ×upper limit pacing frequency] and the eighth proportion of the target heart rate value within this range are obtained. Let the ninth proportion = seventh proportion / eighth proportion. If the ninth proportion is greater than the set upper limit of the ninth proportion, it is determined that the descent time is too slow, and the descent time is reduced by a certain amount; if the ninth proportion is less than the set lower limit of the ninth proportion, it is determined that the descent time is too fast, and the descent time is increased by a certain amount; if the ninth proportion is within the range of the set lower and upper limits of the ninth proportion, it is determined that the current setting is appropriate, and the descent time does not remain unchanged; during the adjustment process, it is ensured that the descent time does not exceed the selectable value range. In this embodiment, γ is a preset value greater than 1, and δ is a preset value less than 1. Preferably, the value range of γ is 1.05-1.20, and the value range of δ is 0.80-0.95. The preferred value of γ is 1.10, and the preferred value of δ is 0.90. The reasonable proportion range of the ninth ratio within the range of [γ×HRmax, δ×HRmax] is 25%-75%, that is, the lower limit and upper limit of the ninth ratio are set to 25% and 75% respectively. If the ninth ratio is greater than 75%, it is determined that the descent time is too slow, and the descent time Dec is reduced by 0.5 minutes. If the ninth ratio is less than 25%, it is determined that the descent time is too fast, and Dec is increased by 0.5 minutes. The value range of Dec is [2, 10] minutes. In this process, the adjustment amount of Dec and the setting of the lower limit and upper limit of the ninth ratio are for illustrative purposes only. In actual application, they can be set according to the requirements. The time-pacing rate decrease curve before and after Dec adjustment is as follows. Figure 8 As shown.

[0056] The automatic parameter optimization adaptive pacing frequency adjustment device provided in this embodiment describes the adaptive adjustment process of the cardiac pacing frequency using the aforementioned functional modules. These functions can be assigned to different functional modules as needed; that is, the computer program stored in the storage medium can be divided into different functional modules to complete all or part of the functions described above. In this embodiment, the automatic parameter optimization adaptive pacing frequency adjustment device can be implemented in an application-specific integrated circuit (ASIC), a digital signal processing (DSP), or a microcontroller (MCU).

[0057] The automatic optimization pacing frequency adaptive adjustment device provided in this embodiment determines the target heart rate value through exercise volume assessment values. It then selects the time-pacing frequency rise / fall curve based on the relationship between the target heart rate value and the actual heart rate value to determine the pacing frequency value for the next moment. Simultaneously, it automatically optimizes and adjusts pacing-related parameters based on the statistical distribution of acceleration signals, exercise volume assessment values, target heart rate values, and pacing frequency values. This simplifies the programming settings of the frequency adaptive adjustment function and ensures that the function always operates at the optimal parameter state, improving the quality of daily life. When daily life conditions change, the pacing-related parameters are also automatically optimized and adjusted to meet the needs of different dynamic changes. After automatic optimization of the upper and lower limits of exercise volume, the exercise volume-target heart rate curve can employ various adjustment strategies to meet the personalized needs of different patients.

[0058] Figure 9 This is a schematic diagram of the cardiac pacing device provided in an embodiment of the present invention. Figure 9 As shown, the cardiac pacing device 900 provided in this embodiment includes: an automatically optimized pacing frequency adaptive adjustment device 901 and a pacing control unit 902. The automatically optimized pacing frequency adaptive adjustment device 901 is the aforementioned pacing frequency adaptive adjustment device 100. This adaptive adjustment device 901 is communicatively connected to the pacing control unit 902. The adaptive adjustment device 901 outputs a cardiac pacing frequency, and the pacing control unit 902 sends cardiac pacing events, i.e., cardiac pacing pulse signals, based on the cardiac pacing frequency output by the automatic adjustment device 901.

[0059] The cardiac pacing device provided in this embodiment adds an automatic parameter optimization function to the existing pacing frequency adaptive adjustment technology, which can make the pacemaker's frequency adaptive adjustment function always work in the optimal parameter state, meet the dynamic and personalized needs of different patients, and improve the patients' quality of life.

[0060] The specific embodiments described above illustrate the technical solution and beneficial effects of the present invention in detail. It should be understood that the above description is only the most preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, additions, and equivalent substitutions made within the scope of the principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A pacing frequency adaptive adjustment device with automatic parameter optimization, characterized in that, The acceleration signal acquisition module, the motion amount evaluation and statistics module, the target heart rate calculation and statistics module, the pacing frequency adjustment and statistics module, and the parameter automatic optimization module are included. The acceleration signal acquisition module is configured to convert the patient physical activity signal collected by the acceleration sensor into an acceleration signal. The motion amount evaluation and statistics module is configured to evaluate the patient's motion amount according to the collected acceleration signal by using a threshold comparison method to obtain a motion amount evaluation value, and to statistically analyze the distribution of the acceleration signal in different acceleration threshold interval ranges and the distribution of the motion amount evaluation value in different motion amount interval ranges within a preset period. The target heart rate calculation and statistics module is configured to determine the target heart rate value that the motion amount evaluation value should reach according to a motion amount-target heart rate curve, and to statistically analyze the distribution of the target heart rate value in different heart rate interval ranges within a preset period. In the target heart rate calculation and statistics module, a preset lower limit motion amount is used. When the motion amount evaluation value at the current time is less than the lower limit motion amount, it is determined that the current time is in a static state, and the target heart rate corresponding to the static state is the lower limit pacing frequency. When the motion amount evaluation value at the current time is not less than the lower limit motion amount, it is determined that the current time is in a motion state, and the target heart rate corresponding to the motion state is calculated according to the motion amount evaluation value M(N) at the current time, the lower limit motion amount Mmin, the upper limit motion amount Mmax, the lower limit pacing frequency HRmin, and the upper limit pacing frequency HRmax: target heart rate TR(N) = (HRmax-HRmin) / (Mmax-Mmin)×(M(N)-Mmin)+HRmin. Then, according to the equal interval of the interval [HRmin, HRmax], the proportion of the target heart rate value in each equal interval within a preset period is statistically analyzed to obtain the distribution of the target heart rate value in different heart rate interval ranges. The pacing frequency adjustment and statistics module is configured to select a time-pacing frequency rising / falling curve according to the size relationship between the target heart rate value and the actual heart rate value to determine the pacing frequency value at the next time, and to statistically analyze the distribution of the pacing frequency value in different heart rate interval ranges within a preset period. The parameter automatic optimization module is configured to automatically optimize and adjust the adaptive pacing related parameters, including the relative acceleration threshold, the lower limit motion amount, the upper limit motion amount, the lower limit pacing frequency, the upper limit pacing frequency, the rising time and the falling time of the pacing frequency, according to the statistical distribution of the acceleration signal, the motion amount evaluation value, the target heart rate value, and the pacing frequency value. The automatic optimization adjustment process of the lower limit exercise amount includes: presetting a daily exercise amount, according to the distribution of the latest exercise amount evaluation value in different exercise amount interval ranges, analyzing a first proportion of the exercise amount in the [lower limit exercise amount, daily exercise amount] interval to the total exercise amount to determine whether the current lower limit exercise amount setting is reasonable, if the first proportion is greater than a set first proportion upper limit value, it is determined that the lower limit exercise amount setting is low, and the lower limit exercise amount is increased by a certain amount; if the first proportion is less than a set first proportion lower limit value, it is determined that the lower limit exercise amount setting is high, and the lower limit exercise amount is reduced by a certain amount; if the first proportion is within the range of the set first proportion lower limit value and the first proportion upper limit value, it is determined that the current lower limit exercise amount setting is reasonable, and the lower limit exercise amount remains unchanged; and the adjustment process ensures that the lower limit exercise amount cannot exceed the settable range; The automatic optimization adjustment process of the upper limit exercise amount includes: according to the distribution of the latest exercise amount evaluation value in different exercise amount interval ranges, analyzing a second proportion of the exercise amount in the [daily exercise amount, upper limit exercise amount] interval to the total exercise amount to determine whether the current upper limit exercise amount setting is reasonable, if the second proportion is greater than a set second proportion upper limit value, it is determined that the upper limit exercise amount is high, and the upper limit exercise amount is reduced by a certain amount; if the second proportion is less than a set second proportion lower limit value, it is determined that the upper limit exercise amount is low, and the upper limit exercise amount is increased by a certain amount; if the second proportion is within the range of the set second proportion lower limit value and the second proportion upper limit value, it is determined that the current setting is reasonable, and the upper limit exercise amount remains unchanged; and the adjustment process ensures that the upper limit exercise amount cannot exceed the settable range; After the automatic optimization adjustment of the lower limit exercise amount, the adjustment strategy of the exercise amount-target heart rate curve includes: keeping the upper limit exercise amount unchanged, adjusting the overall slope of the curve; or keeping the preset daily exercise amount unchanged, only adjusting the slope of the curve less than the daily exercise amount; or keeping the curve slope unchanged, only translating the curve less than the daily exercise amount; After the automatic optimization adjustment of the upper limit exercise amount, the adjustment strategy of the exercise amount-target heart rate curve includes: keeping the lower limit exercise amount unchanged, adjusting the overall slope of the curve; or keeping the preset daily exercise amount unchanged, only adjusting the slope of the curve greater than the daily exercise amount; or keeping the curve slope unchanged, only translating the curve greater than the daily exercise amount.

2. The automatically optimizing parameter pacing rate adaptive adjustment device according to claim 1, characterized in that, In the exercise amount evaluation and statistics module, the main shaft relative acceleration value is calculated according to the acceleration signal at each sampling time, the main shaft relative acceleration value is compared with a plurality of gear relative acceleration threshold values, and the proportion of the main shaft relative acceleration value in each relative acceleration threshold interval is counted to obtain the distribution of the acceleration signal in different acceleration threshold interval ranges in a preset period; The main shaft relative acceleration value is located in different relative acceleration threshold intervals, corresponding to different weight exercise amount scores, the sum of the exercise amount scores of all sampling times in a period of time is taken as the exercise amount evaluation value at the current time, and according to the equal interval of the maximum exercise amount, the proportion of the exercise amount evaluation value in each equal interval in a preset period is counted to obtain the distribution of the exercise amount evaluation value in different exercise amount interval ranges.

3. The automatically-optimizing parameter pacing rate adaptive adjustment device according to claim 1, characterized in that, In the pacing frequency adjustment and statistics module, when the current actual heart rate value is less than or equal to the target heart rate value, the pacing frequency value at the next time is determined through a time-pacing frequency rising curve; When the current actual heart rate value is greater than the target heart rate value, the pacing frequency value at the next time is determined through a time-pacing frequency falling curve; According to the equal interval of the interval [HRmin, HRmax], the proportion of the pacing frequency value in each equal interval in the preset period is counted to obtain the distribution of the pacing frequency value in different heart rate interval ranges.

4. The automatically optimizing parameter pacing rate adaptive adjustment device according to claim 3, characterized in that, The time-pacing frequency rising curve is a linear function curve or an exponential function curve; and the time-pacing frequency falling curve is a linear function curve or an exponential function curve.

5. The automatically-optimizing parameter pacing rate adaptive adjustment apparatus as defined in claim 1 wherein, In the parameter automatic optimization module, the automatic optimization adjustment process of the relative acceleration threshold value includes: According to the distribution of the acceleration signal in the latest preset period in different acceleration threshold value interval ranges, whether the current relative acceleration threshold value setting is reasonable is judged according to a preset judgment standard, if it is judged that the threshold value setting is too high, each acceleration threshold value is reduced by a certain amount, if it is judged that the threshold value setting is too low, each acceleration threshold value is increased by a certain amount, and if it is judged that the threshold value setting is reasonable, it remains unchanged.

6. The automatically-optimizing parameter pacing rate self-adapting adjustment device according to claim 1, characterized in that, In the parameter automatic optimization module, the automatic optimization adjustment process of the lower limit pacing frequency includes: The static state is divided into sleep state, daily rest state and post-exercise rest state, and the lower limit pacing frequency takes different values in different states; if the current is in a sleep period and the rest time is longer than a preset first time length, it is judged to be in a sleep state, and the lower limit pacing frequency is reduced by a certain amount; if the current is in a non-sleep period and the rest time is longer than a preset second time length, it is judged to be in a daily rest state, and the lower limit pacing frequency remains unchanged; if the current continuous rest time is less than a preset third time length, it is judged to be in a post-exercise rest state, and the lower limit pacing frequency is increased by a certain amount; The automatic optimization adjustment process of the upper limit pacing frequency includes: According to the distribution of the target heart rate value in the latest preset period in different heart rate interval ranges, analyze the target heart rate value in the interval of the upper limit pacing frequency and the upper limit pacing frequency α If the third proportion is greater than the set third proportion upper limit value, it is judged that the upper limit pacing frequency is set too low, and the upper limit pacing frequency is increased by a certain amount; if the third proportion is less than the set third proportion lower limit value, it is judged that the upper limit pacing frequency is set too high, and the upper limit pacing frequency is decreased by a certain amount; if the third proportion is within the range of the set third proportion lower limit value and the third proportion upper limit value, it is judged that the current setting is reasonable, and the upper limit pacing frequency remains unchanged; during the adjustment process, the upper limit pacing frequency cannot exceed the settable range, α The preset value is less than 1.

7. The automatically-optimizing parameter pacing rate self-adapting adjustment apparatus as defined in claim 1, characterized by, In the parameter automatic optimization module, the automatic optimization adjustment process of the rising time of the pacing frequency includes: According to the distribution of the target heart rate values in different heart rate interval ranges in the latest preset period and the distribution of the pacing frequency values in different heart rate interval ranges in the preset period, the pacing frequency values in the range of [HRmin, HRmax] are obtained, and the fourth proportion of the pacing frequency values in the range of [HRmin, HRmax] in the total pacing frequency values and the fifth proportion of the target heart rate in the total target heart rate are obtained. β The sixth proportion is equal to the fourth proportion / the fifth proportion. If the sixth proportion is greater than a set upper limit value of the sixth proportion, it is judged that the rising time is too fast, and the rising time is increased by a certain amount. If the sixth proportion is less than a set lower limit value of the sixth proportion, it is judged that the rising time is too slow, and the rising time is decreased by a certain amount. If the sixth proportion is within the range of the set lower limit value and the upper limit value of the sixth proportion, it is judged that the current setting is appropriate, and the rising time remains unchanged. During the adjustment process, it is ensured that the rising time cannot exceed the selectable value range. β The preset value is less than 1. The automatic optimization adjustment process of the falling time of the pacing frequency includes: Based on the distribution of the target heart rate value within different heart rate intervals within the latest preset cycle and the distribution of the pacing frequency value within different heart rate intervals within the preset cycle, the following is obtained: γ ×Lower limit pacing frequency δ [×Upper Limit Pacing Frequency] Within the interval, the pacing frequency value accounts for the seventh percentage of the total pacing frequency value, and the target heart rate value accounts for the eighth percentage of the total target heart rate value. Let the ninth percentage = seventh percentage / eighth percentage. If the ninth percentage is greater than the set upper limit of the ninth percentage, the descent time is considered too slow, and the descent time is reduced by a certain amount. If the ninth percentage is less than the set lower limit of the ninth percentage, the descent time is considered too fast, and the descent time is increased by a certain amount. If the ninth percentage is within the range of the set lower and upper limits of the ninth percentage, the current setting is considered appropriate, and the descent time remains unchanged. During the adjustment process, ensure that the descent time does not exceed the selectable value range. γ A preset value greater than 1 , δ The preset value is less than 1. 。 8. A cardiac pacing device, characterized by It includes: The parameter automatic optimization pacing frequency adaptive adjustment device of any one of claims 1-7; The pacing control unit is in communication connection with the pacing frequency adaptive adjustment device, and is used for sending a heart pacing event, i.e. a heart pacing pulse signal, according to the heart pacing frequency output by the pacing frequency adaptive adjustment device.

Images