Safety-first triggering management device for implantable myocardial contractility modulation

Abstract

The application provides a kind of implantable myocardial contractility regulation safety priority trigger management device, comprising: collecting multiple safety parameters including at least energy supply parameter and body temperature parameter;Based on the quantitative evaluation rule of pre-set, the comprehensive safety score is calculated;When detecting QRS wave, the trigger permission state is determined as one of allowing trigger, limiting trigger or prohibiting trigger according to the score;And according to the determination result, differential operation is carried out, when it is limiting trigger, stimulation is carried out after adjusting stimulation parameter.The application comprehensively quantitatively evaluates multidimensional safety risk and realizes three-level grading control, which comprehensively improves the safety and accuracy of stimulation trigger, and realizes the balance between safety and treatment effectiveness.

Description

Technical Field

[0001] This invention relates to the field of implantable medical device technology, and more specifically, to an implantable safety priority triggering management device for myocardial contractility regulation. Background Technology

[0002] CCM (Continuous Myocardial Contractility Modulation) is an emerging therapy that improves myocardial contractility in patients with heart failure by applying electrical stimulation during the absolute refractory period of the myocardium. To ensure therapeutic efficacy and patient safety, the timing of stimulation triggering must be precise. This is especially true for battery-free implantable CCM devices powered wirelessly, where the operating environment is more complex and safety requirements are higher. Since the energy is derived from external wireless transmission, the supply voltage is susceptible to fluctuations due to changes in coupling efficiency. Simultaneously, physiological parameters such as the temperature of the tissue surrounding the implant and the impedance between the tissue and the electrode are also dynamically changing; all these factors pose potential threats to the safety of triggering.

[0003] In existing technologies, the trigger management of some myocardial contractility modulation devices mainly relies on the detection of QRS waves in electrocardiogram signals. Once a QRS wave is detected, stimulation is triggered. This "single-condition triggering" mode ignores other critical safety factors. For example, if stimulation is forcibly triggered under conditions of unstable power supply voltage, excessively high tissue temperature, or abnormal tissue impedance, it may lead to insufficient or excessive stimulation energy, or even serious consequences such as tissue thermal damage.

[0004] While some existing technologies consider adjusting or switching treatment on / off based on certain physiological parameters or device status, their control logic is relatively coarse, typically involving simple threshold judgments and binary processing—that is, enabling or disabling treatment. This approach lacks a comprehensive quantitative assessment of multi-dimensional safety risks, fails to achieve refined hierarchical control, and struggles to achieve the optimal balance between ensuring absolute safety and maintaining treatment continuity. Furthermore, their emergency response mechanisms are often inadequate, potentially leading to response delays or direct restart of treatment after abnormal recovery, introducing secondary risks. Therefore, existing technologies generally suffer from incomplete safety considerations, a lack of quantitative hierarchical control mechanisms, and delayed emergency response, making them particularly unsuitable for battery-free wireless implantable scenarios with extremely stringent power consumption and safety requirements. Summary of the Invention

[0005] To address the shortcomings of existing technologies, the purpose of this invention is to provide a safety priority triggering management device for implantable myocardial contractility regulation.

[0006] An implantable safety priority triggering management device for myocardial contractility modulation according to the present invention includes: The acquisition module acquires multiple safety parameters, including at least energy supply parameters reflecting energy supply stability and body temperature parameters reflecting tissue thermal safety. The QRS wave detection module detects QRS waves in real time from the acquired electrocardiogram signals, providing a synchronization signal for myocardial stimulation; The main control MCU is configured as follows: Based on preset quantitative evaluation rules, a comprehensive security score is calculated according to the multiple security parameters; When a QRS wave of an electrocardiogram signal is detected, the triggering permission status of myocardial stimulation is determined to be one of permitted triggering, restricted triggering, or prohibited triggering, based on the comprehensive safety score. Differential operations are performed based on the trigger permission status: when triggering is allowed, a myocardial stimulation signal is output; when triggering is restricted, the stimulation parameters are adjusted and a myocardial stimulation signal is output; when triggering is prohibited, the output of the myocardial stimulation signal is prohibited. The adjustment of stimulation parameters includes: A trigger inhibition coefficient is calculated based on the comprehensive safety score, and the stimulation amplitude of the myocardial stimulation signal is reduced based on the trigger inhibition coefficient. The trigger suppression coefficient K(t) = 1 - S total (t) / 100, S total (t) represents the overall safety score; Calibrated stimulus amplitude A stim (t) = A0 × (1 - K(t) × 0.5), the calculated A stim (t) also needs to be compared with the minimum effective stimulus amplitude A min_stim Compare the two values ​​and take the larger one, with A0 being the standard stimulus amplitude.

[0007] Furthermore, the multiple safety parameters also include electrocardiogram (ECG) signal quality parameters and myocardial tissue impedance parameters, and the ECG signal quality parameters are used as indicators to evaluate the reliability of QRS wave detection and are used to calculate the comprehensive safety score.

[0008] Furthermore, the quantitative evaluation rules include: Each safety parameter is assigned an individual safety score, and then all individual safety scores are weighted and summed to obtain the comprehensive safety score. In the weighted summation, the body temperature parameter has the highest weight coefficient.

[0009] Furthermore, the overall safety score S total The calculation method for (t) is as follows:

[0010] Among them, the single safety score for energy supply stability is S U The calculation method for (t) is as follows:

[0011] U is the current power supply voltage. min U max These are the lower and upper limits of the power supply voltage; Temperature safety single-item safety score S T The calculation method for (t) is as follows:

[0012] The temperature of the implanted area within the body; ECG signal quality single-item safety score S Q The calculation method for (t) is as follows:

[0013] The minimum acceptable threshold for the ECG signal quality index is denoted as Q(t), where Q(t) is the current ECG signal quality index. Tissue impedance single-item safety score S Z The calculation method for (t) is as follows:

[0014] Z(t) represents the myocardial tissue impedance. This represents the lower limit of myocardial tissue impedance. This represents the upper limit of myocardial tissue impedance.

[0015] Furthermore, when the overall security score is lower than a preset emergency threshold, the determination of the trigger permission status is suspended, and instead an anomaly level is determined based on the overall security score, and the corresponding emergency handling strategy is executed based on the anomaly level.

[0016] Furthermore, the emergency response strategy includes at least one selected from triggering an alarm, disabling the output of myocardial stimulation signals, and cutting off energy reception.

[0017] Furthermore, after the abnormal state indicated by the abnormality level is resolved, a recovery verification phase is entered, and the normal trigger permission state determination is restored only after the preset recovery conditions are met.

[0018] Furthermore, the recovery verification phase includes an observation period, and the recovery conditions include: During the observation period, the standard deviation of the collected comprehensive safety scores is less than a preset stability threshold.

[0019] Furthermore, in the weighted summation, the weight coefficient of at least one security parameter is dynamically adjusted based on the real-time value of another security parameter.

[0020] Compared with the prior art, the present invention has the following beneficial effects: This invention comprehensively and quantitatively evaluates safety parameters from multiple dimensions, including energy supply stability, body temperature, ECG signal quality, and tissue impedance, and establishes clear safety priorities. It fundamentally solves the problem of existing technologies relying solely on a single ECG signal while ignoring other safety hazards. It ensures that stimulation is only performed when overall safety conditions are met, significantly reducing the risk of myocardial damage caused by unstable energy supply, tissue overheating, etc., thereby comprehensively improving safety.

[0021] This invention features a unique three-level trigger management mechanism of "allow, restrict, and prohibit," which changes the traditional coarse control method of "either on or off." When the safety status slightly declines, it uses "restricted triggering" and adaptive adjustment of stimulation parameters to ensure both the necessary safety margin and the continuity of treatment, achieving a precise balance between safety and treatment effectiveness, and realizing precise hierarchical control.

[0022] This invention includes rapid detection, graded processing, and recovery verification of abnormal states, forming a complete closed-loop management system. It can quickly suppress potential risks and prevent secondary risks caused by immediate recovery after the anomaly is resolved through a security verification mechanism before recovery. The system has high reliability.

[0023] The management method of this invention has a scoring mechanism for power supply fluctuations, which enables it to effectively cope with energy instability in wireless power supply scenarios. Moreover, the algorithm has low power consumption and is highly compatible with battery-free wireless power supply implantable devices that are extremely sensitive to power consumption. Attached Figure Description

[0024] Other features, objects, and advantages of the present invention will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings: Figure 1 This is a schematic diagram of the system structure of an implantable myocardial contractility modulation device provided in an embodiment of the present invention; Figure 2 A flowchart illustrating a security priority triggering management method provided in an embodiment of the present invention; Figure 3 This is a schematic diagram of trigger management state transition provided in an embodiment of the present invention; Figure 4 The signaling interaction timing diagram is provided for the method in the embodiments of the present invention. Detailed Implementation

[0025] The present invention will now be described in detail with reference to specific embodiments. These embodiments will help those skilled in the art to further understand the present invention, but do not limit the invention in any way. It should be noted that those skilled in the art can make several changes and improvements without departing from the concept of the present invention. These all fall within the protection scope of the present invention.

[0026] Example 1 In one embodiment of the present invention, a basic implementation scheme for a safety-priority triggering management method for implantable myocardial stimulation is provided. This method is applied to a battery-free, wirelessly powered implantable myocardial contractility modulation device, which achieves refined, hierarchical control of myocardial stimulation triggering by comprehensively and quantitatively evaluating multi-dimensional safety parameters.

[0027] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Please refer to... Figure 1 This is a schematic diagram of the system structure of the implantable myocardial contractility modulation device used in an embodiment of the present invention. Figure 1 As shown, the system mainly includes an external unit 10 and an internal implantation unit 20. The external unit 10 typically includes a wireless power transmission unit responsible for wirelessly powering the internal implantation unit 20 via electromagnetic coupling or other methods. The internal implantation unit 20, as the part implanted within the patient's body, is the main execution carrier of the method of this invention.

[0028] Specifically, the implantable unit 20 includes a main control MCU 21 as the control core, which connects to and manages multiple functional modules. These modules include: a wireless energy receiving and power management module 22, responsible for receiving energy from the external unit 10 and converting it into a stable DC voltage to supply the entire implantable unit 20; one or more temperature sensors 23, used to monitor the tissue temperature around the implantation area in real time; a myocardial stimulation and impedance detection module 24, which has a dual function: it can apply electrical stimulation to the myocardial tissue according to the instructions of the main control MCU 21, and it can also detect the contact impedance between the stimulation electrode and the myocardial tissue; a QRS wave detection module 25, used to detect QRS waves in real time from the acquired electrocardiogram signals to provide a synchronization signal for myocardial stimulation; and a Bluetooth communication module 26, used for data communication with the external unit 10 or external programming devices, such as reporting device status and receiving parameter adjustment instructions. In this embodiment, the main control MCU 21 coordinates the collaborative work of these modules by executing a preset program to achieve safety-first trigger management.

[0029] See also Figure 2 This illustrates the flow of a security priority triggering management method provided by an embodiment of the present invention. The core logic of this method is executed by the main control MCU 21, and specifically includes the following steps: Step S101, parameter initialization. Before device implantation or through external programming, a series of key parameters are pre-set and stored in the non-volatile memory of the main control MCU 21, serving as the basis for all subsequent calculations and decisions. In this embodiment, the initialized parameters specifically include: 1. Power supply voltage safety range: setting the lower limit U of the power supply voltage. min It is 2.8V, with an upper limit of U. max 3.6V is used to define the normal operating range of the output power supply voltage of the wireless power receiver and power management module 22. 2. Temperature safety upper limit: Sets the upper temperature limit T of the implanted area within the body. b_max The temperature is 39℃. It is understandable that exceeding this temperature may cause thermal damage to tissues. 3. ECG signal quality safety threshold: Set the minimum acceptable threshold Q for the ECG signal quality index. min The value is 60. A value below this indicates that the detection results of the QRS wave detection module 25 may be unreliable. 4. Tissue impedance safe range: Set the normal range of myocardial tissue impedance, with its lower limit Z... min It is 500Ω, with an upper limit of Z. max The impedance is 1500Ω. Abnormal impedance may indicate electrode detachment or tissue fibrosis. 5. Weighting coefficients: To reflect the importance of different safety parameters, respective weighting coefficients are set. Based on safety priority considerations, temperature is considered the highest priority risk, therefore it has the highest weight. Specifically, the temperature weight is W. T =4, power supply voltage weight W U =3, ECG signal quality weight W Q =2, tissue impedance weight W Z =1. 6. Comprehensive Safety Score Threshold: Two thresholds, S1 and S2, are set to classify the trigger permission state. S1 is set to 80, and S2 is set to 50, with S1 > S2. 7. Stimulation Parameters: The standard stimulation amplitude A0 is set to 5V, and the minimum effective stimulation amplitude A0 is set to ensure treatment effectiveness. min_stim It is 3V.

[0030] Step S102: Acquire safety parameters. During normal operation of the device, the main control MCU 21 periodically acquires real-time values ​​of four types of core safety parameters from various associated modules at a relatively high frequency (e.g., 100Hz). Specifically, the main control MCU 21 obtains the current power supply voltage U(t) from the wireless power receiving and power management module 22; and obtains the temperature T of the implanted area from the temperature sensor 23. b (t); obtain the quality index Q(t) of the current electrocardiogram signal from the QRS wave detection module 25; and obtain the myocardial tissue impedance Z(t) from the myocardial stimulation and impedance detection module 24.

[0031] Step S103: Calculate individual and overall scores. After obtaining real-time parameters, the main control MCU 21 immediately performs calculations according to preset quantitative evaluation rules. It should be noted that this calculation process is designed to use low-power fixed-point arithmetic to meet the stringent power consumption requirements of battery-free devices. First, calculate the individual safety score for each safety parameter, with a score range of 0 to 100; a higher score indicates greater safety. Power supply stability individual safety score S U (t) aims to assess the stability of the power supply voltage. The score is highest when the voltage is at the ideal center value, and decreases as it deviates to either side. The calculation formula is:

[0032] Where, if U(t) exceeds [U min U max If the voltage range is U(t) < 2.8V or U(t) > 3.6V, then the power supply is considered to be severely abnormal. U (t) is directly set to 0. Temperature safety single-item safety score S T (t) reflects the risk of thermal safety, scoring highest within the normal body temperature range and decreasing linearly with increasing temperature. Its calculation formula is:

[0033] Among them, T b_max The temperature was 39℃. The single-item safety score for ECG signal quality was S. Q (t) is used to evaluate the reliability of QRS wave detection. When the signal quality is below a threshold, the detection is considered unreliable, and the score is 0. The calculation formula is:

[0034] Among them, Q min The score is 60. The tissue impedance single-item safety score S... Z (t) is used to assess the contact state between the electrode and the tissue. Similar to the power supply voltage, a higher score is given when the impedance is in the ideal central region. However, considering that slight deviations in impedance may still be effective, a lower base score is given even if the impedance is outside the range. The calculation formula is as follows:

[0035] Where Z(t) exceeds [Z min Z max If the range of Z(t) is Z(t) < 500Ω or Z(t) > 1500Ω, then S_Z(t) is set to a lower value, such as 20.

[0036] Subsequently, the main control MCU 21 performs a weighted summation of all individual safety scores according to preset weighting coefficients to obtain a comprehensive safety score S that can characterize the current overall safety status.total (t). The calculation formula is:

[0037] After substituting the weight values, the formula is specifically as follows:

[0038] In step S104, the trigger permission state is determined. The main control MCU 21 waits for the QRS wave detection event signal sent by the QRS wave detection module 25. The reception of this signal marks the start of a valid cardiac cycle and triggers a stimulation decision. Correspondingly, the main control MCU 21 immediately adopts the latest calculated comprehensive safety score S total (t), and compares it with the preset thresholds S1 (80) and S2 (50), so as to dynamically determine the trigger permission state of myocardial stimulation as one of the following three. As shown in Figure 3 , it is a schematic diagram of trigger management state transition. If S total (t) ≥ S1 (80), it is determined as "allow trigger state" 301. If S2 (50) ≤ S total (t) < S1 (80), it is determined as "restrict trigger state" 302. If S total (t) < S2 (50), it is determined as "prohibit trigger state" 303. The dynamic transition between these three states according to the real-time value of S total (t) constitutes the core logic of hierarchical management and control.

[0039] In steps S105, S106, S107 and S108, differentiated stimulation control is executed. According to the determination result of the previous step, the main control MCU 21 sends a corresponding instruction to the myocardial stimulation and impedance detection module 24. For the "allow trigger state" (step S105), it indicates that the overall safety state of the current system is good. The main control MCU 21 will, within the absolute myocardial refractory period after the QRS wave is detected, instruct the myocardial stimulation and impedance detection module 24 to perform one myocardial stimulation with the standard stimulation amplitude A0 (5V) (step S108). Under the "restrict trigger state" (step S106), it indicates that there is a certain safety risk in the system, but it is not enough to completely stop the treatment. In order to balance maintaining treatment and ensuring safety, adaptive adjustment of stimulation parameters is required. Specifically, the main control MCU 21 first calculates a trigger suppression coefficient K(t) that is negatively correlated with the comprehensive safety score: the lower the score, the higher the suppression degree, and its calculation formula is: K(t) = 1 - S total (t) / 100. Then, the stimulation amplitude is reduced based on this suppression coefficient, and the calibrated stimulation amplitude A stim (t) = A0 × (1 - K(t) × 0.5). The calculated Astim (t) also needs to be compared with the minimum effective stimulus amplitude A min_stim (3V) Comparison, the larger of the two values ​​is taken to ensure the effectiveness of the stimulation. Finally, the main control MCU 21 instructs the myocardial stimulation and impedance detection module 24 to use the calibrated amplitude A stim (t) Execute the stimulus (step S108). When it is determined that "triggering is prohibited" (step S107), it indicates that there is a serious safety risk in the system and the treatment must be stopped immediately. At this time, the main control MCU21 will immediately suppress the output of the myocardial stimulation and impedance detection module 24 and will not execute this myocardial stimulation (step S108).

[0040] Step S109, Anomaly Monitoring and Handling. This is a parallel, continuously running monitoring task. When S... total (t) When the value falls below a certain threshold, a higher-level emergency response will be triggered, which will be detailed in other embodiments. After completing a trigger decision and execution, the process returns to step S102 to prepare for the next cardiac cycle, thus forming a closed loop.

[0041] To better understand the technical solution of this invention, an exemplary description is given below. Assume that at a certain moment t1, the main control MCU 21 collects the following parameters: U(t1) = 3.0V, T b (t1)=37.5℃, Q(t1)=90, Z(t1)=800Ω. The main control MCU 21 calculates the scores for each item: S U (t1) = 100 - (|3.0 - (2.8+3.6) / 2| / (3.6-2.8)) 100 = 100 - (|3.0 - 3.2| / 0.8) 100 = 75. S T (t1) = 100 - (37.5 - 37) 20 = 90. S Q (t1) = 90 (because 90 ≥ 60). S Z (t1) = 100 - (|800 - (500+1500) / 2| / (1500-500)) 80 = 100 - (|800 - 1000| / 1000) 80 = 84. Then calculate the overall safety score: S total (t1) ≈ (75) 3 + 90 4 + 90 2 + 84 1) / 10 = (225 + 360 + 180 + 84) / 10 = 84.9. Since Stotal (t1) = 84.9 ≥ 80, the main control MCU 21 determines that the current state is "trigger allowed" 301. After the QRS wave detection module 25 issues a QRS wave detection event, the main control MCU 21 will instruct the myocardial stimulation and impedance detection module 24 to perform stimulation with a standard amplitude of 5V.

[0042] Alternatively, in another embodiment, suppose that at another time t2, the temperature rises to T due to the patient's fever. b (t2) = 38.5℃, with other parameters remaining constant. At this time, S T (t2) = 100 - (38.5 - 37) 20 = 70. New overall safety score S total (t2) ≈ (75 3 + 70 4 + 90 2 + 841) / 10 = (225 + 280 + 180 + 84) / 10 = 76.9. Since 50 ≤ S total Since (t2) = 76.9 < 80, the main control MCU 21 determines the current state to be "limited trigger state" 302. At this time, the trigger suppression coefficient K(t2) = 1 - 76.9 / 100 = 0.231. The calibrated stimulus amplitude A... stim (t2) = 5 (1 -0.231 0.5) ≈ 4.42V. This value is greater than 3V, so it is a valid value. After the QRS wave is detected, the main control MCU 21 will instruct the myocardial stimulation and impedance detection module 24 to perform stimulation with an amplitude of 4.42V.

[0043] Figure 4 The signaling interaction timing during the implementation of this method is illustrated. Within a cardiac cycle, when the QRS wave detection module M1 detects a QRS wave, it sends a QRS wave detection event S1 to the main control MCU M2. Upon activation by this event, the main control MCU M2 immediately sends requests S2 to each sensor / module to obtain safety parameters. After receiving the latest parameter data S3 from each module, the main control MCU M2 executes a calculation and decision process S4, which includes calculating all individual scores, a comprehensive score, and making a final trigger permission determination. It is understood that the entire calculation and decision process is optimized and can be completed in a very short time (e.g., experimental data shows less than 10 milliseconds). Finally, the main control MCU M2 sends a stimulation or inhibition command S5 to the myocardial stimulation module M3. This rapid closed-loop response capability ensures that triggering decisions are made based on the latest safety status.

[0044] This embodiment achieves comprehensive monitoring of multi-dimensional safety parameters and hierarchical trigger management based on quantitative scoring through the above mechanism, thereby ensuring that appropriate triggering strategies are adopted under different safety conditions, which not only guarantees the safety of treatment, but also maintains the continuity of treatment where possible.

[0045] Example 2 As an optional implementation, this embodiment proposes a variant based on Embodiment 1, aiming to provide a more intelligent and sensitive safety assessment mechanism to complex risks. In Embodiment 1, the weights of each safety parameter are fixed. It is understood that in actual physiological environments, different safety risks may have a synergistic amplification effect. For example, an increase in body temperature may not only originate from the external environment or the patient's own fever, but may also be attributed to a decrease in wireless power supply efficiency, leading to increased heat generation by the wireless power receiving and power management module 22. In this case, the risk level of power supply stability should actually be increased accordingly.

[0046] To address this correlation between parameters, this embodiment introduces a dynamic weight adjustment mechanism. The system's hardware structure (such as...) Figure 1 (as shown) and most of the processing flow (such as) Figure 2 (As shown) is consistent with Example 1, with the core improvement being the calculation of the comprehensive safety score S. total In step (S103) of (t), some weighting coefficients are no longer fixed, but are dynamically adjusted according to the real-time values ​​of other safety parameters.

[0047] In this embodiment, the weight W for power supply stability is used. U Let's take an example to illustrate. Its basic weight remains W. U =3, but when the body temperature T detected by temperature sensor 23 b (t) When the temperature exceeds 37°C (normal body temperature), the system considers the risk of heat generation in the power supply module to be increased, thus requiring greater attention to the stability of the power supply voltage. Therefore, the weight W' for power supply stability... U The adjustment will be made dynamically according to the following rules: When T b When (t) ≤ 37℃, W' U = W U = 3. When T b When (t)>37℃, W' U = W U + (T b (t) - 37) × α. Where α is an adjustment factor, set to 2 in this embodiment. To prevent the weights from being infinitely amplified, an upper limit can also be set for them, for example, W' U The upper limit is 6. Therefore, the adjusted formula for the power supply stability weight is:

[0048] Accordingly, the overall safety score S total The formula for calculating (t) has also been updated to:

[0049] Among them, W T =4, W Q =2, W Z =1 remains unchanged.

[0050] The following describes this embodiment through a specific working scenario. Using the parameters from embodiment 1 at time t2: U(t2) = 3.0V, T b (t2)=38.5℃, Q(t2)=90, Z(t2)=800Ω. The calculation results of each individual safety score remain unchanged: S U (t2)≈75, S T (t2)=70, S Q (t2)=90, S Z (t2)≈84.

[0051] Under the fixed weights of Example 1, S total (t2) ≈ 76.9.

[0052] In the dynamic weighting mechanism of this embodiment, due to T b (t2) = 38.5℃ > 37℃, the main control MCU 21 needs to dynamically adjust the weight of power supply stability first: W' U = 3 + (38.5 - 37) 2 = 3 + 1.5 2 = 6. This value does not exceed the upper limit of 6, so it is a valid value. At this point, the new total weight is 6 + 4 + 2 + 1 = 13. The new comprehensive safety score is calculated as follows: S total (t2) ≈ (75 6 + 70 4 + 90 2 + 841) / 13 = (450 + 280 + 180 + 84) / 13 = 994 / 13 ≈ 76.46.

[0053] It should be noted that although the calculated comprehensive safety score of 76.46 in this specific example is very close to the result of 76.9 in Example 1, the underlying risk assessment logic is different. The significance of the dynamic weighting mechanism is that the system's "tolerance" for power supply stability decreases significantly when the temperature rises. Any fluctuation in the power supply voltage U(t) affects the total score S. totalThe negative impact of (t) will be due to the weight W' U The increase is amplified. For example, if the supply voltage also deteriorates slightly at this time, causing S... U If (t) decreases, then under dynamic weights, S total The decrease in (t) will be much greater than that in the case of fixed weights, thus enabling the "limited triggering" or "prohibited triggering" state to be triggered earlier and more sensitively.

[0054] Understandably, this dynamic weighting adjustment strategy can be extended to other parameters. For example, when the ECG signal quality index Q(t) decreases, the weight of tissue impedance Z(t) can be dynamically increased, since poor signal quality may be related to poor electrode contact (manifested as impedance abnormalities).

[0055] In summary, by introducing the synergistic effects between parameters, the safety assessment model in this embodiment is no longer a simple linear superposition, but rather a nonlinear model that reflects the coupling effect of risks. This model can more sensitively capture the "synergistic amplification effect" when multiple risks occur concurrently, making the safety assessment closer to a real physical and physiological model, thereby further improving the accuracy and timeliness of risk warnings and providing patients with a higher level of safety protection.

[0056] Example 3 This embodiment, based on Embodiment 1, further enhances the closed-loop management and recovery mechanism for abnormal states. Its purpose is to address the potential for "false recovery" or "instability after recovery" after an abnormal state is resolved, ensuring that the system's state is truly stable and reliable before resuming normal operation. This functionality mainly corresponds to... Figure 2 The flowchart includes the anomaly monitoring and handling S109 and its subsequent recovery logic.

[0057] In Example 1, when the comprehensive safety score S total When (t) is below the threshold S2(50), the system enters the "trigger-disabled state" 303. total (t) When the value rises above S2, the system will transition to either "limited trigger state" 302 or "allowed trigger state" 301 based on its value. Understandably, while this immediate recovery strategy is simple to implement, it may introduce risks. For example, it could lead to S... total (t) The root cause of the sudden drop (such as poor wireless power contact) may not have been completely eliminated, but only temporarily alleviated. In this case, S total (t) may fluctuate dramatically around the threshold. If high-amplitude stimulation is immediately resumed, it may have adverse effects on the patient should the abnormality recur.

[0058] Therefore, this embodiment introduces an enhanced closed-loop emergency response mechanism consisting of an "observation period" and "recovery trajectory monitoring".

[0059] The specific process of this mechanism is as follows: 1. Abnormal event identification and emergency response: The main control MCU 21 continuously monitors S total (t). When S total When (t) first falls below S2(50), the system not only enters the "prohibited trigger state" 303, but also determines that a "moderate abnormal event" has occurred. At this time, the main control MCU 21 will send a moderate abnormal alarm message to the external unit 10 through the Bluetooth communication module 26, and immediately suppress all stimulation outputs of the myocardial stimulation and impedance detection module 24.

[0060] 2. Entering the observation period: When the factors causing the abnormality subside, S total When the value of (t) rises from below 50 to 50 or above, the system does not immediately return to the state determined by S. total (t) The trigger state is not directly determined, but rather a "viewing period" of a preset duration is entered, such as 30 seconds. At the same time as entering the viewing period, the main control MCU 21 will send the status information of "entering the recovery viewing period" to the external unit 10 through the Bluetooth communication module 26.

[0061] 3. Restriction policy during the observation period: During the entire 30-second observation period, the system's trigger permission state is forcibly locked in "Restricted Trigger State" 302, even if S... total The instantaneous value of (t) may be much higher than the threshold S1. This means that when a QRS wave is detected during the observation period, the system will only execute the adjusted (i.e., reduced amplitude) stimulus. As an optional implementation, to ensure absolute safety, the calibrated stimulus amplitude A can be set during the observation period. stim (t) is restricted to a stricter upper limit, for example, not exceeding 80% of the standard stimulus amplitude A0 (i.e., 4V).

[0062] 4. Recovery Trajectory Monitoring: During the observation period, the core task of the main control MCU 21 is not only to confirm whether the score value has been recovered, but more importantly, to evaluate the quality of the recovery process. Specifically, the main control MCU 21 not only records the S... total The instantaneous value of (t) is also stored in a sliding window buffer of size 10 seconds, and all S values ​​within that window are calculated in real time. total (t) The standard deviation σ of the sampled values. This standard deviation σ intuitively reflects the stability or volatility of the overall safety score. For a system that recovers stably, its S... total The t-value should remain stable at a high level, with a small standard deviation σ; conversely, a "false recovery" or unstable system will have a small standard deviation σ. total The value of (t) will fluctuate drastically, resulting in a large standard deviation σ.

[0063] 5. Final Verification Upon Exiting the Observation Period: At the end of the 30-second observation period, the system will perform a final recovery verification. The system is considered to have fully stabilized and recovered, and can exit the observation period and return to the state set by S, only when both of the following conditions are met simultaneously. total (t) Normal trigger management mode determined by real-time value (i.e., the mode in Example 1): a. Scoring criteria: All S values ​​collected within the last 5 seconds of the observation period. total The instantaneous values ​​of (t) must all be greater than S1(80) to ensure that the system is in a highly safe state at the end of the observation period.

[0064] b. Stability condition: The calculated S during the last 10 seconds of the observation period. total The standard deviation σ of (t) must be less than a preset stability threshold (e.g., 2.0) to ensure that the recovery state is stable rather than fluctuating drastically.

[0065] 6. Handling of Verification Failure: If any of the above conditions are not met at the end of the observation period, the main control MCU 21 will determine it as "unstable recovery". In this case, the system will not exit the observation period, but will handle it according to the preset strategy, for example, extending the observation period by another 30 seconds and continuing to maintain the restriction strategy and monitoring. At the same time, the main control MCU 21 will send a "Unstable recovery, extended observation period" prompt message to the external unit 10 through the Bluetooth communication module 26 so that the doctor or patient can understand the situation.

[0066] The following is a working example illustrating this process. Assume that due to a drastic change in the patient's body posture, the coupling between the external unit 10 and the internal implanted unit 20 is briefly interrupted, causing a sudden drop in the wireless power supply voltage U(t), resulting in S... total (t) dropped rapidly from 85 to 30. The system immediately entered "trigger-disabled state" 303 and sent a moderate anomaly alarm. A few seconds later, the patient returned to a normal posture, power supply was restored, and S total (t) quickly rises to 85. At this point, the system does not immediately stimulate with a standard amplitude of 5V, but automatically enters a 30-second observation period. During this period, even if S total (t) remained at 85, and the amplitude of any triggered stimulus was limited to a maximum of 4V. The main control MCU 21 continuously monitored S during the observation period. total The stability of (t). Assume that during the observation period, due to imperfect coupling, the supply voltage experiences small fluctuations, leading to S... total (t) fluctuated between 82 and 88, but the standard deviation σ was always less than 2.0. At the end of the observation period, the S value for the last 5 seconds... totalThe t values ​​are all greater than 80, and the standard deviation σ of the last 10 seconds is also less than 2.0. The system determines that the recovery is successful, exits the observation period, and returns to the normal trigger management mode. Alternatively, in another scenario, if the power supply recovery is unstable, causing S... total If the value of (t) fluctuates wildly between 75 and 90, and the calculated standard deviation σ is greater than 2.0, then after the observation period ends, the system will be classified as "recovering from instability" and will continue to maintain the restricted state, while issuing an external alert.

[0067] Correspondingly, this enhanced closed-loop emergency response mechanism, by introducing an "observation period" and "recovery trajectory monitoring," can effectively prevent the system from rashly resuming full-power operation when the safety status is unstable. It elevates the consideration of safety management from "meeting instantaneous value standards" to the level of "continuous stability of the status," thereby significantly improving the robustness of the system and the safety of long-term use.

[0068] Example 4 This embodiment provides a simplified safety-priority triggering management scheme, designed to reduce power consumption and focus on core risks. In certain specific clinical applications or device models with stringent cost and power consumption requirements, a more streamlined yet still effective safety management strategy may be needed. The core idea of ​​this embodiment is to select only the two highest priority parameters—the body temperature T, which reflects tissue thermal safety—based on the safety priorities established in Embodiment 1 (temperature > power supply > ECG quality > tissue impedance). b (t) and the power supply voltage U(t) reflecting the stability of power supply – serve as the basis for safety assessment.

[0069] This simplified solution is proposed primarily based on the following considerations: Overheating and power interruption are the two most direct and fatal physical risks associated with implantable devices and must be prioritized. While ECG signal quality and tissue impedance are also important, their impact is relatively indirect in some cases or can be compensated for through other means. Therefore, a safety management system that only includes the two core parameters of temperature and power supply, although reducing the number of information dimensions, can still cover the vast majority of serious safety events, achieving a cost-effective protection.

[0070] The hardware structure of this embodiment (such as...) Figure 1 (as shown) and the overall methodology (as shown) Figure 2 The procedure shown is largely the same as that in Example 1, but the specific execution steps have been simplified.

[0071] 1. Parameter Initialization (Step S101): The list of parameters to be initialized is reduced, and only the safe range of the power supply voltage needs to be set [U]. min U max Temperature safety upper limit T b_max and the corresponding weighting coefficient WT and W U The comprehensive safety scoring thresholds S1 and S2, as well as the stimulus parameter A0, are still required. In this embodiment, the weights can be reallocated to emphasize the importance of both, for example, maintaining W... T =4, W U =3.

[0072] 2. Safety Parameter Acquisition (Step S102): The acquisition task of the main control MCU 21 is simplified, requiring only the acquisition of the power supply voltage U(t) from the wireless power receiving and power management module 22, and the body temperature T from the temperature sensor 23. b (t). The acquisition of ECG signal quality Q(t) and tissue impedance Z(t) for safety score calculation is no longer required, but the QRS wave detection module 25 still needs to operate to provide a trigger synchronization signal. This reduces the load on bus communication and data processing, thereby further reducing power consumption.

[0073] 3. Calculate individual and overall scores (step S103): This step has been significantly simplified. The main control MCU 21 only needs to calculate the single safety score S for power supply stability. U (t) and temperature safety single-item safety score S T (t), whose calculation formula is exactly the same as in Example 1. Subsequently, the comprehensive safety score S total The formula for calculating (t) is simplified to:

[0074] 4. After substituting the weight values, the formula is:

[0075] 5. Trigger Management (Steps S104 to S108): The subsequent trigger permission status determination, hierarchical execution, and control steps are logically identical to those in Example 1. In other words, the main control MCU 21 still operates based on this simplified S... total The comparison between (t) and thresholds S1 and S2 determines whether to perform "allow triggering", "restrict triggering", or "disable triggering". In the "restrict triggering" state, the adjustment of the stimulus amplitude is also based on this simplified S... total The trigger inhibition coefficient K(t) is calculated using (t).

[0076] The following working example demonstrates the operation of this simplified scheme. Assume that at a certain moment, the collected parameters are: U(t) = 3.0V, T b (t) = 37.5℃. The main control MCU 21 calculates the individual score: S U (t) = 100 - (|3.0 -3.2| / 0.8) 100 = 75. S T (t) = 100 - (37.5 - 37) 20 = 90. Calculate the simplified overall safety score: S total (t) ≈ (75 3 + 90 4) / (3+4) = (225 + 360) / 7 = 585 / 7 ≈ 83.57. Since S total (t) = 83.57>80 (S1), the main control MCU 21 determines that the trigger state is "allowed" 301. After receiving the QRS wave signal, standard myocardial stimulation will be performed.

[0077] This scheme ignores the impact of ECG signal quality and tissue impedance fluctuations on safety scores, focusing instead on the core risks of thermal safety and power supply safety. The scheme in this embodiment has the following advantages: First, it provides a lower-cost, less computationally intensive, and lower-power alternative, suitable for applications with extreme requirements for cost and battery life. Second, it demonstrates that the core idea of ​​this invention, "multi-parameter quantitative assessment and hierarchical control," remains effective and feasible even with simplified parameter sets. Furthermore, this embodiment provides support for constructing a multi-layered protection system; for example, it can strongly support a technical solution that only requires "at least power supply parameters reflecting power supply stability and in vivo temperature parameters reflecting tissue thermal safety," thereby achieving a wider range of protection.

[0078] Those skilled in the art will understand that, besides implementing the system and its various devices, modules, and units provided by this invention in the form of purely computer-readable program code, the same functions can be achieved entirely through logical programming of the method steps, making the system and its various devices, modules, and units of this invention function in the form of logic gates, switches, application-specific integrated circuits, programmable logic controllers, and embedded microcontrollers. Therefore, the system and its various devices, modules, and units provided by this invention can be considered as a hardware component, and the devices, modules, and units included therein for implementing various functions can also be considered as structures within the hardware component; alternatively, the devices, modules, and units for implementing various functions can be considered as both software modules implementing the method and structures within the hardware component.

[0079] Specific embodiments of the present invention have been described above. It should be understood that the present invention is not limited to the specific embodiments described above, and those skilled in the art can make various changes or modifications within the scope of the claims, which do not affect the essence of the present invention. Unless otherwise specified, the embodiments and features of the present invention can be arbitrarily combined with each other.

Claims

1. An implantable safety priority triggering management device for myocardial contractility regulation, characterized in that, include: The acquisition module acquires multiple safety parameters, including at least energy supply parameters reflecting energy supply stability and body temperature parameters reflecting tissue thermal safety. The QRS wave detection module detects QRS waves in real time from the acquired electrocardiogram signals, providing a synchronization signal for myocardial stimulation; The main control MCU is configured as follows: Based on preset quantitative evaluation rules, a comprehensive security score is calculated according to the multiple security parameters; When a QRS wave of an electrocardiogram signal is detected, the triggering permission status of myocardial stimulation is determined to be one of permitted triggering, restricted triggering, or prohibited triggering, based on the comprehensive safety score. Differential operations are performed based on the trigger permission status: when triggering is allowed, a myocardial stimulation signal is output; when triggering is restricted, the stimulation parameters are adjusted and a myocardial stimulation signal is output; when triggering is prohibited, the output of the myocardial stimulation signal is prohibited. The adjustment of stimulation parameters includes: A trigger inhibition coefficient is calculated based on the comprehensive safety score, and the stimulation amplitude of the myocardial stimulation signal is reduced based on the trigger inhibition coefficient. The trigger suppression coefficient K(t) = 1 - S total (t) / 100, S total (t) represents the overall safety score; Calibrated stimulus amplitude A stim (t) = A0 × (1 - K(t) × 0.5), the calculated A stim (t) also needs to be compared with the minimum effective stimulus amplitude A min_stim Compare the two values ​​and take the larger one, with A0 being the standard stimulus amplitude.

2. The implantable myocardial contractility modulation safety priority triggering management device according to claim 1, characterized in that, The multiple safety parameters also include electrocardiogram (ECG) signal quality parameters and myocardial tissue impedance parameters, and the ECG signal quality parameters are used as an indicator to evaluate the reliability of QRS wave detection and are used to calculate the comprehensive safety score.

3. The implantable myocardial contractility modulation safety priority triggering management device according to claim 1, characterized in that, The quantitative evaluation rules include: Each safety parameter is assigned an individual safety score, and then all individual safety scores are weighted and summed to obtain the comprehensive safety score. In the weighted summation, the body temperature parameter has the highest weight coefficient.

4. The implantable myocardial contractility modulation safety priority triggering management device according to claim 1, characterized in that, Overall safety rating: S total The calculation method for (t) is as follows: Among them, the single safety score for energy supply stability is S U The calculation method for (t) is as follows: U is the current power supply voltage. min U max These are the lower and upper limits of the power supply voltage; Temperature safety single-item safety score S T The calculation method for (t) is as follows: The temperature of the implanted area within the body; ECG signal quality single-item safety score S Q The calculation method for (t) is as follows: The minimum acceptable threshold for the ECG signal quality index is denoted as Q(t), where Q(t) is the current ECG signal quality index. Tissue impedance single-item safety score S Z The calculation method for (t) is as follows: Z(t) represents the myocardial tissue impedance. This represents the lower limit of myocardial tissue impedance. This represents the upper limit of myocardial tissue impedance.

5. The implantable myocardial contractility modulation safety priority triggering management device according to claim 1, characterized in that, When the overall security score is lower than a preset emergency threshold, the determination of the trigger permission status is suspended, and instead an anomaly level is determined based on the overall security score, and the corresponding emergency handling strategy is executed based on the anomaly level.

6. The implantable myocardial contractility modulation safety priority triggering management device according to claim 5, characterized in that, The emergency response strategy includes at least one selected from triggering an alarm, disabling the output of myocardial stimulation signals, and cutting off energy reception.

7. The implantable myocardial contractility modulation safety priority triggering management device according to claim 5, characterized in that, After the abnormal state indicated by the abnormality level is resolved, a recovery verification phase is entered, and the normal trigger permission state determination is restored only after the preset recovery conditions are met.

8. The implantable myocardial contractility modulation safety priority triggering management device according to claim 7, characterized in that, The recovery verification phase includes an observation period, and the recovery conditions include: During the observation period, the standard deviation of the collected comprehensive safety scores is less than a preset stability threshold.

9. The implantable myocardial contractility modulation safety priority triggering management device according to claim 3, characterized in that, In the weighted summation, the weight coefficient of at least one security parameter is dynamically adjusted based on the real-time value of another security parameter.

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