Synergistic control system for battery-free implantable myocardial contractility modulation device

Abstract

This invention provides a collaborative control system for a battery-free implantable myocardial contractility modulation device, comprising: pre-setting the priority of operating tasks; real-time monitoring of operating parameters to calculate power supply margin parameters; dynamically allocating computing resources based on priority and power supply margin; acquiring the recognition confidence level of electrocardiogram signals; determining whether to allow the output of myocardial stimulation pulses based on the recognition confidence level and power supply margin, thereby achieving safety interlocking; and feeding back the power supply status to the external unit to adjust the power. This application, through dynamic computing power scheduling and stimulation safety interlocking, combined with internal and external closed-loop control, ensures the operation of core tasks, guarantees the safe and effective output of stimulation, and improves system stability.

Description

Technical Field

[0001] This invention relates to the field of implantable medical device technology, specifically to a safety collaborative control system based on data priority and power supply status in a battery-free implantable myocardial contractility regulating device. Background Technology

[0002] A battery-free implantable myocardial contractility modulation system wirelessly powers the implanted device, solving problems associated with traditional solutions such as the limited lifespan of implanted batteries requiring surgical replacement and the large device size. Existing technologies typically employ resonant coupling for wireless power supply, using adaptive adjustment of the external transmitter's power to compensate for fluctuations in wireless coupling efficiency caused by factors such as changes in body posture, thereby maintaining power supply stability. In some existing solutions, the implanted device can monitor its own power supply voltage and feed this status back to the external transmitter, which then adjusts its transmission power accordingly, forming a closed-loop power control system to maintain power supply stability.

[0003] However, the aforementioned existing technologies primarily focus on optimizing the energy transmission link, neglecting the real-time computational resource requirements and stringent safety constraints of implanted diagnostic and therapeutic procedures. For example, when wireless power supply temporarily decreases due to changes in body position, the system's total computing power decreases accordingly. Routine non-critical tasks such as communication and storage may preempt the computational resources required for core ECG analysis tasks, leading to delays in critical QRS complex identification. This can cause stimulation pulses to miss the safety window, potentially inducing fatal arrhythmias. Furthermore, due to the lack of a backup energy storage unit, existing systems lack mechanisms to dynamically shut down low-priority tasks or link them to stimulation output when power supply is insufficient. This could result in the system attempting to output stimulation pulses even under severely insufficient power conditions, but the pulse amplitude would be insufficient and the waveform distorted, failing to achieve the therapeutic effect and potentially interfering with normal ECG rhythms. Summary of the Invention

[0004] To address the shortcomings of existing technologies, the purpose of this invention is to provide a safe and coordinated control system for a battery-free implantable myocardial contractility modulation device.

[0005] A collaborative control system for a battery-free implantable myocardial contractility modulation device according to the present invention includes: The priority setting module is used to pre-divide the operating tasks of the device in the body into multiple priorities, among which the core tasks related to electrocardiogram signal processing are set as the highest priority; The status monitoring module is used to monitor the operating parameters of the device in real time and calculate an energy margin parameter that characterizes the current energy supply status based on the operating parameters. The signal acquisition module is used to acquire electrocardiogram (ECG) signals. The resource allocation module is used to dynamically allocate computing resources to the multiple running tasks based on the priority of the tasks and the power supply margin parameters. The signal processing module is used to perform electrocardiogram (ECG) signal processing, which is the core task, to obtain the recognition confidence level of the ECG signal. The safety interlock module is used to determine whether to allow the output of myocardial stimulation pulses based on the recognition confidence of the electrocardiogram signal and the power supply margin parameter. The feedback module is used to feed back the power supply status of the device to the external power supply unit so that the external power supply unit can adjust its transmission power. The resource allocation module divides the energy supply status into at least a first under-energy condition and a second under-energy condition according to the energy supply margin parameter, wherein the energy supply situation of the second under-energy condition is worse than that of the first under-energy condition. When the system is in the first underpowered operating condition, reduce or shut down the computing resources of some low-priority tasks. When in the second underpowered operating condition, only the highest priority task and a preset specific second-highest priority task are kept running; When the system is in the first underpowered condition or the second underpowered condition, the output power of the external power supply unit is increased in a stepwise manner, realizing the synergistic effect of the inner and outer double-layer closed loop.

[0006] Furthermore, the running tasks are divided into five priority levels, with the core task being the highest priority level 0 task.

[0007] Furthermore, the operating parameters include real-time rectified voltage, implantation temperature, and myocardial electrode impedance.

[0008] Furthermore, the energy supply margin parameter is calculated using the following formula:

[0009] in, For real-time rectified voltage, The preset minimum operating voltage, The preset rated voltage, The temperature decay coefficient is based on the implantation temperature. This is the electrode impedance attenuation coefficient based on myocardial electrode impedance.

[0010] Furthermore, the priority of the task is determined by its inherent priority weight. The decision to dynamically allocate computing resources to the multiple running tasks includes: Monitoring equipment anomaly level; Based on the inherent priority weight of the task, the power supply margin parameter, and the equipment anomaly level, the running weight of each task is calculated using the following formula:

[0011] in, For running weights, For inherent priority weights, For energy margin parameters, The equipment malfunction level is represented by α and β, which are preset coefficients.

[0012] Furthermore, the steps for determining whether to allow the output of myocardial stimulation pulses include: Myocardial stimulation pulses are only allowed to be output when the recognition confidence level is not less than the first preset threshold and the energy margin parameter is not less than the second preset threshold.

[0013] Furthermore, the safety interlocking module is configured as follows: A CCM stimulation pulse safety interlocking check is performed once during each cardiac cycle, and the check logic is a double-condition AND logic:

[0014] in, To stimulate the enabling signal, To identify confidence levels for QRS, To identify a confidence safety threshold for QRS, To stimulate the minimum energy margin threshold for output, This refers to the energy supply margin parameter.

[0015] Furthermore, in the event of a functional failure, all tasks except the highest priority task will be shut down; During power restoration, tasks are woken up in stages according to the priority of the task and the power margin parameter.

[0016] Compared with the prior art, the present invention has the following beneficial effects: 1. Enhance core security: Through rigid task priority division and dynamic computing power allocation, the absolute priority of core ECG analysis tasks is ensured under any power supply conditions, fundamentally eliminating recognition delays and stimulation timing misalignments caused by computing power preemption, and significantly reducing the clinical risk of inducing arrhythmias.

[0017] 2. Achieve flexible power consumption scheduling and system stability: Based on the quantified power supply margin, the system actively degrades or shuts down unnecessary low-priority tasks when power is insufficient, thus achieving adaptive flexible scheduling of system power consumption. Without affecting core security, it effectively reduces the overall power consumption of the implant and improves the stability of the system under power supply fluctuations.

[0018] 3. Ensure the effectiveness and safety of stimulation: The innovative stimulation safety lockout logic uses ECG recognition confidence and energy supply margin as dual conditions for stimulation delivery, eliminating invalid and dangerous stimulation when ECG signal recognition is unreliable or energy is insufficient, ensuring that every stimulation is safe and effective.

[0019] 4. Construct an intelligent control system that integrates internal and external operations: The dual-layer closed-loop architecture of internal business computing power scheduling and external wireless power regulation enables the system to cope with complex internal and external changes in a coordinated manner throughout the entire process, filling the gap in the existing technology where the energy layer and business layer are separated.

[0020] 5. Enhanced clinical compatibility and engineering feasibility: This invention is fully compatible with existing hardware platforms, has low upgrade costs, and has strong engineering feasibility. Attached Figure Description

[0021] 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 a two-layer closed-loop control system architecture provided in an embodiment of this application.

[0022] Figure 2 A flowchart of a security collaborative control method provided in an embodiment of this application.

[0023] Figure 3 Signaling interaction timing diagram for the method embodiment provided in this application. Detailed Implementation

[0024] 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.

[0025] Example 1 This embodiment details the implementation of a safety-coordinated control system based on data priority and power supply status in a battery-free implantable myocardial contractility modulator under rated power supply conditions. It is understood that this condition typically corresponds to the patient being in a resting or stable state, where the wireless coupling between the external device and the implanted device is good, and energy transmission efficiency is high and stable.

[0026] Please see Figure 1This is a schematic diagram of the dual-layer closed-loop control system architecture provided in this application embodiment. The system is composed of an external transmitting unit 10 and an internal implanted device 20. The external transmitting unit 10 serves as the energy source and external control center, and its internal components mainly include a main control module, a power control module 11, and a wireless transmitting module 12. The power control module 11 may be a module with an embedded lookup table, responsible for adjusting the output power according to instructions; the wireless transmitting module 12 may be a high-efficiency Class E power amplifier, responsible for converting electrical energy into a high-frequency electromagnetic field and transmitting it wirelessly.

[0027] The implantable device 20 is implanted in the patient's body and serves as the core component for performing electrocardiogram (ECG) monitoring and myocardial stimulation therapy. This device does not contain batteries or high-capacity energy storage elements; its operation relies entirely on real-time received wireless energy. Specifically, the implantable device 20 includes: a wireless receiving module 21 for receiving externally emitted energy and converting it into electrical energy; a power management module 22 for rectifying, filtering, and regulating the received unstable AC power to provide a stable DC operating voltage for the entire implantable device; a main control microcontroller 23, serving as the control core of the implantable device and responsible for running the core safety collaborative control algorithm proposed in this application; an ECG acquisition front-end 24 for acquiring real-time ECG signals from the patient via electrodes implanted in the myocardium; a CCM stimulation output circuit 25, under the precise control of the main control microcontroller 23, for generating and applying therapeutic myocardial contractility modulation stimulation pulses to the myocardium; and a sensor group 26 for real-time monitoring of physical parameters of the implantation area (e.g., temperature and myocardial tissue electrode impedance).

[0028] like Figure 1 As shown, energy flow is unidirectionally transmitted from the external transmitting unit 10 to the implanted device 20. Correspondingly, information flow is bidirectional: the main control microcontroller 23 of the implanted device 20 feeds back key information such as its operating status and power supply status to the external transmitting unit 10 via wireless communication; the power control module 11 of the external transmitting unit 10 then dynamically adjusts the transmission power of the wireless transmitting module 12 based on this feedback information, thus forming an "external energy closed loop". At the same time, inside the implanted device 20, the main control microcontroller 23 performs fine-grained control of its own task operation and stimulation output based on real-time perceived power supply status and electrocardiogram data, forming an "in-vivo operational safety closed loop". These two closed loops work together to form the dual-layer closed-loop control system of this application.

[0029] In one specific embodiment of this application, to ensure the safety and resource protection of different services, all software tasks running in the main control microcontroller 23 of the implantable device 20 are pre-divided into five fixed, rigid priorities based on their risk level and importance to cardiac safety. This division is the basis for achieving safe scheduling. Specifically: Highest priority (Level 0): Safety-critical tasks. This level includes core tasks directly related to patient life safety, including real-time acquisition of ECG signals, beat-by-beat identification of QRS complexes, calculation of cardiac cycles, and timing judgment of CCM stimulation safety windows. These tasks must receive the highest priority computing power under any power supply conditions and are not allowed to be down-frequency, paused, or interrupted. Second highest priority (Level 1): Secondary critical safety detection tasks. This level includes tasks that play an important role in ensuring the safe operation of the system, such as continuous monitoring of myocardial electrode lead impedance to determine whether the electrodes have fallen off or have poor contact. Medium priority (Level 2): ​​Equipment operation monitoring tasks. This level includes routine monitoring tasks that maintain the stable operation of the equipment itself, such as monitoring the operating temperature of the main control microcontroller 23 and self-checking the memory status. Lower Priority (Level 3): Routine Communication and Storage Tasks. This level includes tasks that interact with external devices or record data, such as sending telemetry data to the host computer via Bluetooth Low Energy or writing operation logs to non-volatile memory. These tasks do not have high real-time requirements. Lowest Priority (Level 4): Redundant and Non-Essential Tasks. This level includes redundant data acquisition tasks used for R&D debugging or non-core functions.

[0030] Please refer to the following: Figure 2 This is a flowchart of the safety collaborative control method provided in this application embodiment. Under rated power supply conditions, the execution process of this method is as follows: In step S201, the main control microcontroller 23 continuously collects multiple key operating parameters through its internal analog-to-digital converter and the connected sensor group 26. Specifically, it collects the real-time rectified and regulated voltage output by the power management module 22, denoted as... The real-time temperature T of the implantation area is obtained through the temperature sensor in the sensor group 26; and the real-time impedance Z of the myocardial electrode is measured through the ECG acquisition front end 24.

[0031] Subsequently, in step S202, the main control microcontroller 23 uses the parameters acquired in step S201 to calculate a dimensionless real-time wireless power margin coefficient η using a preset real-time wireless power margin quantitative calculation formula. The formula is:

[0032] in, Provide the device's rated operating voltage (e.g., 3.3V). This is the minimum operating voltage (e.g., 2.4V) required for the device to maintain the safe operation of its core functions. It is a temperature decay coefficient obtained based on the temperature of the implantation area. These are electrode impedance attenuation coefficients obtained based on the myocardial electrode impedance. These two attenuation coefficients can be calculated using tables or formulas and are used to correct for the impact of temperature or impedance changes on the actual usable power. Under this rated power supply condition, assuming... It stabilizes at 3.35V, with both temperature and impedance within ideal ranges, making... It is 0.98. The value is 0.95. Therefore, the calculated value of η is:

[0033] In step S203, the main microcontroller 23 compares the calculated η value with a preset operating condition threshold. In one embodiment of this application, the operating conditions are divided into: rated power supply (η ≥ 0.8), slight power shortage (0.5 ≤ η < 0.8), severe power shortage (0.2 ≤ η < 0.5), and power supply failure (η < 0.2). Since the currently calculated η value is 0.97, which is much greater than 0.8, the main microcontroller 23 determines that the system is in the "rated power supply" operating condition.

[0034] In step S204, the main control microcontroller 23 calculates the dynamic scheduling priority weight for each running task in real time. This calculation is performed using the following multi-task dynamic scheduling comprehensive priority decision formula:

[0035] in, It is the inherent basic priority weight of the task (e.g., level 0 task). W 0=10, Level 1 task W 1=6, ..., 4-level task W4=0.2), α is the power supply sensitivity coefficient (e.g., 0.4), and β is the equipment anomaly amplification coefficient (e.g., 0.5). This refers to the hardware fault level corresponding to this task. Under this condition, it is assumed that there are no hardware faults, and all... All are 0. Since η = 0.97 is very close to 1, the (1-η) term is extremely small, resulting in the (1 + α × (1 - η)) term being approximately equal to 1.012. Therefore, the dynamic priority weights of each task... Its inherent weight The weights are roughly proportional, with high-priority tasks still having a much higher weight than low-priority tasks.

[0036] In step S205, the real-time operating system scheduler of the main microcontroller 23 calculates the time according to step S204. The scheduler allocates computing resources to all tasks. Under "rated power" conditions, with ample total energy and computing power, the scheduler allocates sufficient CPU time slices to all five levels of tasks, enabling them to run at full speed without delay.

[0037] In step S206, after the ECG acquisition front-end 24 acquires the ECG signal, the ECG analysis algorithm, as the highest priority level 0 task, is immediately executed. Due to sufficient computing power, this algorithm can perform complete filtering, baseline drift correction, QRS complex detection, and morphological analysis on the ECG signal, ultimately outputting a high-quality real-time QRS complex identification confidence score (Conf). For example, for a clear QRS complex, its Conf value can reach 0.95.

[0038] Subsequently, in the crucial step S207, the main control microcontroller 23 performs a CCM stimulation pulse safety lockout determination once per cardiac cycle. This determination logic is a double-condition AND logic:

[0039] in, To stimulate the enabling signal, To identify confidence levels for QRS, Identify a confidence safety threshold (e.g., 0.85) for QRS. This is the minimum energy margin threshold for the stimulus output (e.g., 0.35). Under this condition, Conf = 0.95 (greater than 0.85) and η = 0.97 (greater than 0.35), both conditions are met.

[0040] Therefore, in step S208, since When the value is 1, the main control microcontroller 23 determines that stimulation is permitted. It will accurately calculate the safe stimulation window within the absolute refractory period of the ventricle and send an instruction to the CCM stimulation output circuit 25 to deliver a CCM therapeutic pulse with a complete waveform and standard amplitude at the correct time.

[0041] Finally, in step S209, the main control microcontroller 23 packages the current system status, including the power supply condition as "rated power supply," the η value as 0.97, all tasks operating normally, and stimuli being delivered normally, into a status data frame and sends it to the external transmitting unit 10 via the wireless communication link. Upon receiving this information, the external transmitting unit 10's power control module 11 determines that the internal device is powered well and therefore maintains the current reference transmission power unchanged. Afterward, the process returns to step S201 to begin the next control cycle.

[0042] like Figure 3As shown in the timing diagram, during the initial normal phase, the implanted device periodically sends status feedback to the external transmitter unit, indicating that the system is operating normally. The entire process of this embodiment demonstrates the system's full-function operation mode under ideal conditions, where all diagnostic, monitoring, and communication functions work normally, thereby providing effective CCM treatment for patients.

[0043] Example 2 This embodiment describes the flexible degradation and coordinated adjustment process of the control method provided in this application under the condition of a slight decrease in wireless power supply, i.e., "slight underpowerment". This scenario may occur when the patient undergoes a slight change in body position (e.g., from lying flat to turning on their side), resulting in a decrease in the coupling efficiency between the external transmitting coil and the internal receiving coil.

[0044] Reference Figure 1 and Figure 2 When the aforementioned body position change occurs, the energy received by the wireless receiving module 21 of the implanted device 20 decreases, resulting in a reduction in the rectified and regulated voltage V output by the power management module 22. rec The temperature drops. In step S201, the main control microcontroller 23 acquires V... rec It has dropped from 3.35V to, for example, 2.9V.

[0045] In step S202, the main microcontroller 23 calculates the power margin coefficient η using the same formula. This assumes temperature and impedance attenuation coefficients. and If they remain 0.98 and 0.95, then:

[0046] In step S203, the main control microcontroller 23 compares η=0.51 with the preset threshold and determines that it falls within the range of [0.5, 0.8), so the system enters the "slightly underpowered" working condition.

[0047] Upon entering the "mild underpowerment" operating condition, the system immediately activates the preset flexible degradation strategy. In step S204, the main control microcontroller 23 recalculates the dynamic priority weights of each task. At this point, η = 0.51, and the term (1 + α × (1 - η)) becomes (1 + 0.4 × (1 - 0.51)) ≈ 1.196. This factor makes the dynamic weights of tasks with higher intrinsic weights W_i more stable. The increase is even greater, thus giving it a greater advantage in resource competition and enabling a further concentration of computing power on core tasks.

[0048] In step S205, the scheduler of the main microcontroller 23, according to the new... The system allocates computing power based on preset rules for "slightly underpowered" operating conditions. As an optional implementation, this degradation strategy can include: 1. Completely shutting down (suspending) all lowest-priority Level 4 tasks, such as stopping the acquisition of all redundant parameters, to maximize resource conservation; 2. Degrading lower-priority Level 3 tasks instead of completely shutting them down, for example, reducing the Bluetooth communication baud rate with the host computer from 1Mbps to 250kbps, or extending the log cache write interval from once per second to once every five seconds. This degradation significantly reduces task power consumption and CPU utilization while preserving basic functionality; 3. Simultaneously, ensuring that Level 0, Level 1, and Level 2 core and critical tasks receive all necessary computing resources to maintain their full-speed, uninterrupted operation.

[0049] In step S206, since the computing power of the level 0 task is absolutely guaranteed, the execution of the electrocardiogram analysis algorithm is not affected and can still stably output QRS recognition results with high confidence (e.g., Conf=0.94).

[0050] In step S207, a stimulus safety lockout determination is performed. At this time, Conf = 0.94 (greater than 0.85) and η = 0.51 (greater than 0.35), both conditions are still met simultaneously.

[0051] Therefore, in step S208, S en The signal remains at 1, and the CCM stimulation output circuit 25 is allowed to deliver treatment pulses normally. This demonstrates the advantage of the method in this application in ensuring uninterrupted core treatment functions.

[0052] In step S209, the main control microcontroller 23 feeds back the current status to the external transmitter unit 10. This information clearly includes the working condition indicator of "slight underpowerment", the value of η is 0.51, and detailed task operation status such as level 4 task has been shut down and level 3 task has been downgraded.

[0053] Reference Figure 3 In the second stage of the signaling interaction timing diagram, the power control module 11 of the external transmitting unit 10 responds immediately upon receiving status feedback indicating a decrease in the η value. This module queries its internal power adjustment lookup table and, based on the value η=0.51, determines that the transmission power needs to be increased by one or more levels to compensate for the energy loss caused by the decrease in coupling efficiency. Correspondingly, the output power of the wireless transmitting module 12 is increased in stages.

[0054] Through the above process, this embodiment demonstrates how the system can proactively reduce power consumption and ensure core functions when faced with slight power supply fluctuations by using an internal flexible degradation strategy (shutting down and downgrading low-priority tasks), while simultaneously stabilizing energy supply through an external power compensation mechanism (increasing transmission power). This successfully achieves the synergistic effect of the internal and external double-layer closed loop, ensuring the continuity of treatment and the stability of the system.

[0055] Example 3 This embodiment aims to illustrate in detail how the method of this application triggers a key stimulus safety interlock mechanism under conditions of severe wireless power shortage, i.e., "severe power deficiency," to reflect its highest safety principle of "not causing harm." This scenario may arise from a patient performing significant physical movements (such as bending over or lying deeply on their side), causing a severe misalignment between the external and internal coils, resulting in a significant drop in the efficiency of the wireless power supply link.

[0056] In this scenario, the energy received by the implanted device 20 decreases dramatically. Figure 2 In step S201, the main control microcontroller 23 monitors the voltage V output by the power management module 22. rec It has fallen to a lower level, such as 2.6V.

[0057] In step S202, the main control microcontroller 23 calculates the power margin coefficient η:

[0058] In step S203, the main control microcontroller 23 determines that η=0.21 falls into the range of [0.2, 0.5), and the system enters the "severe underpowerment" working condition.

[0059] The system then executes a more stringent resource contraction strategy. In steps S204 and S205, the scheduler of the main microcontroller 23 takes the following measures: 1. Immediately and completely shut down all Level 4 and Level 3 tasks, which means that all data communication and logging functions will be suspended, and the relevant data can be temporarily stored in the RAM cache, waiting to be processed after power is restored; 2. Level 2 tasks (equipment operation monitoring) are also strictly downgraded, for example, their sampling period is significantly extended from once every 100 milliseconds to once every 2 seconds, and only intermittent, low-frequency self-checks are performed; 3. All available resources are used to ensure the full-speed operation of Level 0 (core ECG tasks) and Level 1 (secondary critical safety detection tasks) to ensure that, even in extreme cases, the patient's heart rhythm and electrode status can still be accurately monitored.

[0060] In step S206, since the computing power of the level 0 task is still guaranteed, the ECG analysis algorithm can still accurately process the acquired ECG signals and output a reliable QRS wave recognition confidence level, such as Conf=0.92.

[0061] At this point, the process enters the most critical step S207, where a stimulus safety interlock determination is performed. The main microcontroller 23 performs a dual condition check: First condition: Conf ≥ Conf th The condition 0.92 ≥ 0.85 is true, indicating that the ECG signal recognition is reliable. The second condition: η ≥ η th The condition 0.21 ≥ 0.35 is false, indicating that the current energy margin is below the minimum energy threshold required to safely deliver a complete and effective stimulus pulse. Since the two conditions are in an AND logical relationship, if either condition is false, the final result is false.

[0062] Therefore, in step S208, the stimulus enable signal S output by the safety interlocking determination logic is... en The value is 0. Based on this, the main control microcontroller 23 forcibly locks the CCM stimulation output circuit 25, preventing the delivery of stimulation pulses even if the ECG signal is accurately identified. This mechanism successfully avoids the risk of ineffective or even harmful pulses due to insufficient energy output amplitude or waveform distortion, thus protecting the myocardium from potential electrical interference. It should be noted that while CCM treatment is paused at this time, the device's core function—cardiac rhythm monitoring—continues to operate normally.

[0063] In step S209, the main control microcontroller 23 reports an emergency status to the external transmitter unit 10 via wireless communication. This status information clearly includes the operating condition of "severe underpowerment", an η value of 0.21, and most importantly, the status of "stimulus output has been locked".

[0064] Reference Figure 3 In the third stage of the timing diagram, when the external transmitting unit 10 receives this emergency signal, its power control module 11 will immediately make the highest level of response, such as bypassing the conventional step-by-step adjustment and directly increasing the transmission power command of the wireless transmitting module 12 to the upper limit allowed by the system, making every effort to restore the power supply link in order to get the implanted device 20 out of the severe power shortage state as soon as possible.

[0065] This embodiment fully demonstrates the safety fallback capability of the method in extreme situations. By dual-binding the power supply margin with the confidence level of ECG recognition, intelligent and safe locking of stimulation output is achieved. While sacrificing some therapeutic functions (pausing stimulation), the principle of "safety first" is upheld, and the most core monitoring function is retained. At the same time, it is linked with external devices for strong compensation.

[0066] Example 4 This embodiment describes the highest safety protection logic of the method in this application under the extreme condition of impending power interruption, i.e., a "power failure" situation. This scenario corresponds to the extreme case where the external device is accidentally detached or the coil is completely misaligned, resulting in a near-complete interruption of wireless power supply. This embodiment aims to demonstrate how the system "keeps alive" its most critical functions and achieves safe recovery.

[0067] In the event of a power supply failure, the energy received by the implanted device 20 is negligible. Figure 2 In step S201, the main control microcontroller 23 detects V rec The voltage has been reduced to a critical value, such as 2.45V, which is only slightly above the minimum safe operating voltage. min (2.4V).

[0068] In step S202, the power margin coefficient η calculated by the main microcontroller 23 will be extremely low:

[0069] In step S203, the main control microcontroller 23 determines that η=0.05 is far below the threshold of 0.2, and the system enters the most severe "power supply failure" condition.

[0070] At this point, the system enters its highest safety protection mode, with the sole objective of maintaining the minimum operation of the most critical functions using the remaining meager residual energy. In steps S204 and S205, the main microcontroller 23 performs the most thorough resource reduction: immediately shutting down or placing all tasks except the highest priority level 0 task (including levels 1, 2, 3, and 4). In other words, even the secondary critical safety detection task at level 1 is temporarily abandoned to ensure that every microwatt of power is supplied to level 0 tasks.

[0071] In "power failure" mode, even a Level 0 task may be downgraded to a "silent monitoring" state. For example, the main control microcontroller 23 may only maintain the operation of the ECG acquisition front-end 24 and perform basic QRS wave detection on the acquired data at an extremely low frequency, solely to determine the presence or absence of a heartbeat, without performing complex morphological analysis or confidence calculations. All other functions, including stimulus output (naturally latched due to η being far below the threshold), wireless communication, log storage, and device self-testing, are all disabled to maximize the duration of the core monitoring function.

[0072] In this state, the implanted device 20 enters a silent monitoring mode, silently monitoring the patient's native electrocardiographic rhythm while waiting for power to be restored. Since the communication function is disabled, it will no longer send feedback to the external unit (step S209 is skipped). Alternatively, the external transmitting unit 10 can detect the loss of the power transmission link by means of changes in its own transmitting coil impedance, triggering an alarm to prompt the user to check the device's fit.

[0073] An important aspect of this embodiment is the stable restart strategy after power supply is restored. Once the user has re-worn the external device and the power supply link is re-established, the V of the implanted device 20... rec The η value will begin to rise. At this time, the main microcontroller 23 will not immediately wake up all tasks, because this would cause a momentary power consumption surge, which may cause the system voltage to drop again and trigger a "secondary power failure".

[0074] Instead, the main microcontroller 23 executes a smooth, phased recovery strategy. When the η value is detected to rise and stabilize above 0.2, the Level 1 secondary critical safety detection task is first activated to check the system status. When the η value further rises and stabilizes above 0.5, the Level 2 device monitoring task is activated, and the Level 3 communication task is restored in the previously degraded mode (e.g., low baud rate) to report to the external system that the system is recovering. Finally, when the η value has fully recovered to the "rated power supply" condition above 0.8, all tasks are restored to full-speed operation, and the CCM stimulation output is re-enabled based on the safety interlock determination result (at which point η has met the condition).

[0075] This embodiment, through its extreme protection and stable recovery strategy, ensures that the most critical cardiac electrophysiological monitoring function is maintained to the greatest extent possible in the worst-case scenario of impending shutdown, preserving a valuable data window for clinical judgment and emergency treatment. After power is restored, the orderly and smooth restart process ensures the stability and safe transition of the system.

[0076] 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 described in this application can be arbitrarily combined with each other.

Claims

1. A collaborative control system for a battery-free implantable myocardial contractility modulation device, characterized in that, include: The priority setting module is used to pre-divide the operating tasks of the device in the body into multiple priorities, among which the core tasks related to electrocardiogram signal processing are set as the highest priority. The status monitoring module is used to monitor the operating parameters of the device in real time and calculate an energy margin parameter that characterizes the current energy supply status based on the operating parameters. The signal acquisition module is used to acquire electrocardiogram (ECG) signals. The resource allocation module is used to dynamically allocate computing resources to the multiple running tasks based on the priority of the tasks and the power supply margin parameters. The signal processing module is used to perform electrocardiogram (ECG) signal processing, which is the core task, to obtain the recognition confidence level of the ECG signal. The safety interlock module is used to determine whether to allow the output of myocardial stimulation pulses based on the recognition confidence of the electrocardiogram signal and the power supply margin parameter. The feedback module is used to feed back the power supply status of the device to the external power supply unit so that the external power supply unit can adjust its transmission power. The resource allocation module divides the energy supply status into at least a first under-energy condition and a second under-energy condition according to the energy supply margin parameter, wherein the energy supply situation of the second under-energy condition is worse than that of the first under-energy condition. When the system is in the first underpowered operating condition, reduce or shut down the computing resources of some low-priority tasks. When in the second underpowered operating condition, only the highest priority task and a preset specific second-highest priority task are kept running; When the system is in the first underpowered condition or the second underpowered condition, the output power of the external power supply unit is increased in a stepwise manner, realizing the synergistic effect of the inner and outer double-layer closed loop.

2. The collaborative control system of the battery-free implantable myocardial contractility modulation device according to claim 1, characterized in that, The running tasks are divided into five priority levels, with the core task being the highest priority level 0 task.

3. The collaborative control system of the battery-free implantable myocardial contractility modulation device according to claim 1, characterized in that, The operating parameters include real-time rectified voltage, implantation temperature, and myocardial electrode impedance.

4. The collaborative control system of the battery-free implantable myocardial contractility modulation device according to claim 1, characterized in that, The energy supply margin parameter is calculated using the following formula: in, For real-time rectified voltage, The preset minimum operating voltage, The preset rated voltage, The temperature decay coefficient is based on the implantation temperature. This is the electrode impedance attenuation coefficient based on myocardial electrode impedance.

5. The collaborative control system of the battery-free implantable myocardial contractility modulation device according to claim 1, characterized in that, The priority of the task is determined by its inherent priority weight. The decision to dynamically allocate computing resources to the multiple running tasks includes: Monitoring equipment anomaly level; Based on the inherent priority weight of the task, the power supply margin parameter, and the equipment anomaly level, the running weight of each task is calculated using the following formula: in, For running weights, For inherent priority weights, For energy margin parameters, The equipment malfunction level is represented by α and β, which are preset coefficients.

6. The collaborative control system of the battery-free implantable myocardial contractility modulation device according to claim 1, characterized in that, The steps to determine whether to allow the output of myocardial stimulation pulses include: Myocardial stimulation pulses are only allowed to be output when the recognition confidence level is not less than the first preset threshold and the energy margin parameter is not less than the second preset threshold.

7. The collaborative control system of the battery-free implantable myocardial contractility modulation device according to claim 5, characterized in that, The safety interlocking module is configured as follows: A CCM stimulation pulse safety interlocking check is performed once during each cardiac cycle, and the check logic is a double-condition AND logic: in, To stimulate the enabling signal, To identify confidence levels for QRS, To identify a confidence safety threshold for QRS, To stimulate the minimum energy margin threshold for output, This refers to the energy supply margin parameter.

8. The collaborative control system of the battery-free implantable myocardial contractility modulation device according to claim 1, characterized in that, In the event of a functional failure, shut down all tasks except the highest priority task; During power restoration, tasks are woken up in stages according to the priority of the task and the power margin parameter.

Images