Implantable myocardial contractility modulation device with endocardial dual electrode cooperation

Abstract

The application provides an endocardial double-electrode coordinated implantable myocardial contraction regulating device, and relates to the technical field of implantable medical devices. The device comprises an implant body and a double electrode, wherein the implant body is electrically connected with the double electrode; the implant body comprises an algorithm control unit and a medium-frequency electric stimulation module; and the medium-frequency electric stimulation module generates corresponding electric stimulation pulses to the double electrode according to the instructions output by the algorithm control unit. Through closed-loop adaptive control, the application realizes accurate quantification of the interaction state of the double electrode and the endocardium, coordinated compensation of impedance drift, on-demand regulation of stimulation energy and correction of long-term stability of the system, thereby significantly improving the reliability, stability and safety of the implanted device.

Description

Technical Field

[0001] This invention relates to the field of implantable medical device technology, specifically to an implantable myocardial contraction regulation device with endocardial dual-electrode coordination. Background Technology

[0002] Modulated myocardial contraction (CCM) is an electrical stimulation therapy used to treat heart failure. It applies specific electrical pulses to myocardial tissue via an implanted device. The endocardial electrode, a key component of this device, is responsible for accurately and stably transmitting the electrical stimulation signal to the endocardium. To improve stimulation efficacy and stability, the use of a dual-electrode structure has become a technological trend.

[0003] However, existing endocardial dual-electrode techniques and their control strategies have shortcomings. First, in terms of structural design, existing electrodes are mostly rigid or symmetrical structures, making it difficult to adapt to the irregular curved surface of the endocardium and the continuous peristalsis of the myocardium. This may lead to unstable electrode-tissue adhesion, contact gaps, signal attenuation, or damage to endocardial tissue due to excessive local pressure. Second, in terms of control strategies, the primary and secondary electrodes often operate independently, lacking a synergistic mechanism. When a single electrode experiences poor adhesion or impedance drift due to blood flow impact, tissue hyperplasia, or other reasons, the system cannot perform synergistic compensation, resulting in a decrease in overall stimulation effect and poor reliability. Furthermore, some existing adaptive adjustment methods typically have relatively simple stimulation parameter adjustment logic, and most do not fully consider the complex dynamic factors of the endocardial implantation environment, such as temperature fluctuations, tissue fluid corrosion, and electrode material aging. They cannot dynamically optimize based on the real-time physical interaction between the electrode and the tissue, which may not only waste energy but also cause unnecessary tissue electrical stimulation damage. More importantly, existing solutions generally lack a closed-loop correction mechanism to combat parameter drift caused by long-term operation (such as electrode aging and material fatigue), making it difficult to guarantee the long-term operating accuracy and stability of the device. Summary of the Invention

[0004] To address the shortcomings of existing technologies, the purpose of this invention is to provide an implantable myocardial contraction regulation device with endocardial dual-electrode coordination.

[0005] An implantable myocardial contraction modulation device with endocardial dual-electrode coordination according to the present invention includes: an implant body and dual electrodes, wherein the implant body is electrically connected to the dual electrodes; The implant body includes an algorithm control unit and a mid-frequency electrical stimulation module; The intermediate frequency electrical stimulation module generates corresponding electrical stimulation pulses to the dual electrodes according to the instructions output by the algorithm control unit; The algorithm control unit is configured to perform the following steps and output instructions: Initialization steps: Initialize the impedance compensation adjustment coefficient and the stimulation parameter adjustment coefficient; Quantification steps of dual-electrode collaborative adhesion state: Based on multiple real-time parameters collected from the dual electrodes, the dual-electrode collaborative adhesion state coefficient, which characterizes the overall adhesion state between the dual electrodes and the endocardium, is calculated. Dual-electrode impedance co-compensation step: Based on the real-time parameters, the dual-electrode co-adhesion state coefficient, and the impedance compensation adjustment coefficient, the compensated impedance is calculated to compensate for the impedance drift of the dual electrodes; Stimulation parameter coordination adjustment step: Based on the dual-electrode coordinated fit state coefficient, the compensated impedance, and the stimulation parameter adjustment coefficient, the parameters of the electrical stimulation signal applied to the dual electrodes are dynamically and coordinatedly adjusted. Closed-loop feedback correction step: Based on the deviation between the actual output value and the corresponding target value obtained from at least one measurement characterizing the operating state or myocardial response state of the implanted myocardial contraction regulation device, the impedance compensation adjustment coefficient and the stimulation parameter adjustment coefficient are dynamically corrected.

[0006] Furthermore, the multiple real-time parameters collected in the dual-electrode collaborative bonding state quantification step include: bonding pressure, contact impedance, operating temperature, tensile deformation, blood flow impact pressure fluctuation, and dual-electrode spacing of each of the two electrodes.

[0007] Furthermore, the dual-electrode impedance collaborative compensation step specifically includes: calculating the impedance compensation amount of the main electrode and the auxiliary electrode based on the real-time contact impedance, working temperature, and blood flow impact pressure fluctuation of the dual electrodes, and in combination with the dual-electrode collaborative adhesion state coefficient.

[0008] Furthermore, the coordinated regulation step of the stimulation parameters specifically includes: Based on the dual-electrode synergistic fit coefficient, the compensated impedance, the deviation between the working temperature and a preset reference temperature, the distance between the dual electrodes, and the fluctuation of blood flow impact pressure, the amplitude, pulse width, and frequency of the electrical stimulation signals of the main electrode and the secondary electrode are dynamically adjusted, wherein the preset reference temperature is a pre-set reference temperature value.

[0009] Furthermore, the closed-loop feedback correction step specifically includes: After the stimulation parameters are adjusted in a coordinated manner, the recalculated dual-electrode coordinated fit state coefficient, the impedance compensation amount, and the actual values ​​of the stimulation parameters are collected in real time. Calculate the adjustment deviation between the actual values ​​of the dual-electrode synergistic adhesion state coefficient, the impedance compensation amount, and the stimulation parameters and their respective preset target values; Based on the adjustment deviation of the dual-electrode cooperative bonding state coefficient, the impedance compensation adjustment coefficient is dynamically adjusted; and The adjustment coefficient of the stimulation parameter is dynamically adjusted based on the impedance compensation amount and / or the adjustment deviation of the stimulation parameter.

[0010] Furthermore, the algorithm control unit also includes components configured to: Based on the aforementioned multiple real-time parameters, a quantitative and graded real-time safety warning is issued, and corresponding emergency procedures are performed when the warning level triggers preset conditions.

[0011] Furthermore, the algorithm control unit also includes components configured to: When the fluctuations of the dual-electrode collaborative bonding state coefficient and the compensated impedance within a preset time period are both less than their respective preset thresholds, the system enters a low-power standby mode; and When a command is received or at least one of the dual-electrode cooperative bonding state coefficient or the compensated impedance is detected to exceed a preset safety range, the system is woken up from the low-power standby mode.

[0012] Furthermore, the algorithm control unit also includes components configured to: When an abnormal state is detected in the dual electrodes, such as open circuit, short circuit, or impedance value exceeding a preset threshold, the roles of the main and secondary electrodes are dynamically switched to ensure the continuity of electrical stimulation.

[0013] Furthermore, it also includes: an external control module and a wireless power supply module; The external control module is configured to set parameters, monitor status, and issue commands to the implant. The wireless power supply module is configured to provide the implant with the electrical power required for operation via wireless power transmission. Compared with the prior art, the present invention has the following advantages: This invention achieves accurate and real-time quantitative evaluation of the complex interaction between dual electrodes and the endocardium through a collaborative bonding state quantification algorithm, significantly improving the bonding reliability and synergy of electrodes in dynamic environments.

[0014] This invention utilizes an impedance co-compensation algorithm to effectively compensate for impedance drift caused by factors such as temperature, aging, and blood flow impact, ensuring stable and efficient transmission of stimulation energy.

[0015] This invention utilizes a stimulation parameter collaborative adjustment algorithm to enable stimulation parameters to adapt to real-time changes in fit, impedance, and spacing, achieving "on-demand allocation" of stimulation, improving energy utilization efficiency, and avoiding unnecessary tissue damage.

[0016] This invention uses a closed-loop feedback correction mechanism to dynamically counteract control parameter drift caused by electrode aging, material fatigue, etc., thus ensuring the long-term operational accuracy and reliability of the device.

[0017] Furthermore, this invention, through a quantitative and graded safety early warning algorithm and a dynamic switching mechanism for the roles of primary and secondary electrodes, can capture and handle various safety hazards in real time, ensuring the continuity of stimulation when the primary electrode is abnormal, thus greatly improving the safety and reliability of the implanted device. Attached Figure Description

[0018] 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 architecture of an implantable myocardial contraction regulation system provided in an embodiment of this application; Figure 2 This is a schematic diagram of the endocardial dual electrode structure provided in an embodiment of this application; Figure 3 A flowchart illustrating an endocardial dual-electrode collaborative control method provided in this application embodiment; Figure 4 This is a timing diagram illustrating the signaling interaction between the modules in the embodiments of this application. Detailed Implementation

[0019] 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.

[0020] Example 1 This embodiment provides an implantable myocardial contraction modulation device with endocardial dual-electrode coordination, which can achieve precise sensing of the interaction state between the dual electrodes and endocardial tissue, coordinated compensation for impedance drift, on-demand adjustment of stimulation energy, and long-term stability correction of the control system itself.

[0021] Reference Figure 1This figure is a schematic diagram of the overall architecture of the implantable myocardial contraction regulation system used in this embodiment. The system mainly includes an external control module 10 and a wireless power supply module 20 located outside the body, and an implant body 30 implanted inside the patient. The external control module 10 is used for parameter setting, status monitoring, and command issuance to the implant body 30. The wireless power supply module 20 provides the necessary electrical energy to the implant body 30 through percutaneous wireless power transmission technology. As the core carrier of the technical solution of this application, the implant body 30 internally encapsulates an algorithm control unit 31 and a mid-frequency electrical stimulation module 32, and is electrically connected to the endocardial dual electrodes 40. The algorithm control unit 31 can typically be implemented by a low-power microcontroller or application-specific integrated circuit, and is the main body for executing the collaborative control method described in this embodiment. Correspondingly, the mid-frequency electrical stimulation module 32 generates electrical stimulation pulses with specific parameters according to the instructions output by the algorithm control unit 31. The endocardial dual electrode 40, as a component that directly interacts with the endocardium, is responsible for both applying electrical stimulation signals to the myocardial tissue and collecting various physical parameters that reflect its own interaction with the tissue.

[0022] The following will combine Figure 3 and Figure 4 The technical solutions in the embodiments of this application are clearly and completely described, wherein... Figure 3 This is a detailed flowchart of the collaborative control method described in this embodiment. Figure 4 This demonstrates the signaling interaction timing between various modules of the system. In one embodiment of this application, the cooperative control method may specifically include the following steps: Step S101: Initialization. Upon first startup of the implantable myocardial contraction modulation device or during routine maintenance, the algorithm control unit 31 loads a series of preset baseline values, thresholds, and internal adjustment coefficients from its internal non-volatile memory. It should be noted that these parameters are fundamental to ensuring the accurate operation of the algorithm and are typically obtained through extensive offline experimental calibration. For example, in an experimental setup simulating a human body environment (temperature 35℃-39℃, simulated body fluids), by changing the electrode contact pressure and stretching state, the corresponding changes in impedance, temperature, and other parameters are recorded, thereby calibrating a series of baseline values. In this embodiment, the initialization parameters may include: contact pressure baseline value. For example, set to 0.12 Newtons; contact resistance reference value For example, set to 500 ohms; dual electrode spacing reference value For example, set to 5 millimeters; and stimulus amplitude baseline value. Pulse width reference value Frequency reference value Meanwhile, a series of adjustment coefficients used to control the internal logic of the algorithm are also initialized, such as impedance compensation adjustment coefficients (e.g., impedance compensation correlation coefficients). , , ) and stimulus parameter regulation coefficients (such as stimulus parameter regulation correlation coefficients) , , , , These coefficients determine the algorithm's sensitivity and adjustment range in response to changes in input.

[0023] Step S102: Acquire multidimensional sensor data. Within each cycle of the control loop (e.g., response time no greater than 7 milliseconds), the algorithm control unit 31 transmits data to the sensing and monitoring layer 42 of the endocardial dual electrode 40 (see...). Figure 2 The sensor monitoring layer 42 integrates multiple micro-sensors, capable of measuring and returning a series of real-time parameters reflecting the physical state of the electrodes synchronously. Understandably, these parameters form the data basis for a comprehensive assessment of the electrode-tissue interaction state. Specifically, the acquired real-time parameters include the respective contact pressures of the main and secondary electrodes. and The contact impedances were measured by the microelectromechanical system pressure sensor 421. and The operating temperature of each circuit was obtained by measuring the circuit using the four-point method. and The tensile deformation was measured by a miniature thermistor or other temperature sensor 422; and This parameter can be calculated collaboratively from changes in adhesion pressure and contact impedance, or measured directly by strain gauges integrated into the flexible electrode structure. Additionally, it includes fluctuations in blood flow impact pressure measured by sensors integrated on the implant body 30. And the real-time spacing between the two electrodes measured by sensors on the flexible dual-electrode bridge. These data are transmitted through conductive layer 43 (see...). Figure 2 Transmitted back to the algorithm control unit 31.

[0024] Step S103: Calculate the co-fitting state coefficient. This step aims to integrate the collected multi-dimensional, discrete physical parameters into a single index that can comprehensively and quantitatively characterize the overall reliability and synergy of the two electrodes' fit with the endocardium, namely the two-electrode co-fitting state coefficient. Specifically, the algorithm control unit 31 first calculates the individual bonding state coefficients of the main electrode and the secondary electrode respectively. and This calculation comprehensively considers factors such as bonding pressure, contact resistance, operating temperature, tensile deformation, and the common environmental factor of blood flow impact. The calculation formula can be:

[0025]

[0026] in, and The real-time contact impedances of the main and secondary electrodes and their reference values ​​are respectively. Deviation; and This represents the deviation between the real-time operating temperature and the preset reference temperature (e.g., 37°C). The coefficients in the formula (e.g., 0.08, 0.02, 0.01, 0.1) are weighting coefficients calibrated through offline experiments, reflecting the degree of influence of different physical parameters on the bonding state. For example, the exponential decay term of the contact impedance indicates that the greater the impedance deviation from the reference value, the worse the bonding state. Furthermore, the algorithm control unit 31 combines the two individual bonding state coefficients with the influence of the dual-electrode spacing to calculate the final dual-electrode collaborative bonding state coefficient. Its formula can be:

[0027] This formula reflects the different importance of the main electrode (weight 0.6) and the secondary electrode (weight 0.4) in their cooperative operation, and introduces a penalty term for the cooperativeness caused by deviations of the electrode spacing from the reference value. The resulting... It is a dimensionless value. The closer its value is to 1, the more ideal the overall adhesion of the two electrodes and the better the synergy.

[0028] Step S104: Calculate the impedance compensation amount and obtain the compensated impedance. Considering the complexity of the endocardial environment, factors such as temperature fluctuations, tissue proliferation, and blood flow impact can all cause the contact impedance of the electrodes to drift, thereby affecting the stable transmission of stimulation energy. Therefore, this step aims to calculate the amount of compensation required for the output impedance based on the real-time status to counteract this drift. The algorithm control unit 31, based on the real-time contact impedance, operating temperature, and blood flow impact pressure fluctuations collected in step S102, and combined with the dual-electrode cooperative adhesion state coefficient calculated in step S103, calculates the impedance. The impedance compensation amounts for the main electrode and the secondary electrode are calculated using the following dual-electrode impedance synergistic compensation formula. and :

[0029]

[0030] in, , It is the impedance compensation adjustment coefficient (a part of the impedance compensation adjustment coefficient) related to the main and secondary electrodes. This is the temperature compensation adjustment coefficient. This formula shows that the impedance compensation amount is not only related to the deviation of the impedance itself, but also affected by the combined effects of temperature, blood flow impact, and the overall fit. For example, when the overall fit coefficient... When the impedance is low, the compensation magnitude will be reduced accordingly to avoid overcompensation when the fit is poor. After calculating the compensation amount, the algorithm control unit 31 can obtain the compensated impedance and use it as the input for the next calculation.

[0031] Step S105: Adjusting stimulation parameters. This step, as the core of achieving adaptive stimulation, aims to dynamically and collaboratively adjust the electrical stimulation signal parameters applied to the dual electrodes based on the real-time changing electrode-tissue interaction state, in order to achieve energy conservation and safety while ensuring therapeutic efficacy. The algorithm control unit 31 calculates based on step S103... The compensated output impedance obtained in step S104 and In addition to other real-time parameters, the amplitude, pulse width, and frequency of the electrical stimulation signals from the main and secondary electrodes are dynamically adjusted through a series of coordinated stimulation parameter adjustment formulas. As an optional implementation method, the specific adjustment formula can be designed as follows: Coordinated Stimulation Amplitude Adjustment Formula:

[0032]

[0033] Stimulation pulse width co-regulation formula:

[0034]

[0035] Stimulus frequency coordination regulation formula:

[0036] in, , , , , These are the stimulus parameter adjustment coefficients (a part of the stimulus parameter adjustment coefficients). These formulas embody a refined adjustment logic: when the coefficient of the co-fit state... At higher levels, the stimulation amplitude and pulse width are increased accordingly to ensure the stimulation effect; conversely, they are reduced to conserve energy and avoid damage to tissues with unstable contact. Simultaneously, factors such as temperature, blood flow, and electrode spacing are also incorporated into the regulation model, achieving multivariate synergistic optimization.

[0037] Step S106: Output stimulus signal. The algorithm control unit 31 outputs the final stimulus parameters (amplitude) calculated in step S105. , pulse width , ,frequency , The signal is sent to the intermediate frequency electrical stimulation module 32. The intermediate frequency electrical stimulation module 32 generates a corresponding electrical pulse sequence and applies it to the target location on the endocardium through the endocardial dual electrode 40.

[0038] Step S107: Calculate the adjustment deviation and correct the internal coefficient. To address system parameter drift caused by long-term factors such as electrode aging, material fatigue, and tissue encapsulation, this embodiment introduces a closed-loop feedback correction mechanism. After each control cycle, the algorithm control unit 31 collects or recalculates the actual output values ​​of the adjusted system state, such as the actual value of the adjusted dual-electrode cooperative fit state coefficient, the actual value of the impedance compensation amount, and the actual value of the stimulation parameters. Then, these actual output values ​​are compared with preset ideal target values ​​(e.g., the target value of the cooperative fit state coefficient). (It can be set to 0.85) for comparison, and the adjustment deviation can be calculated, such as the deviation of the fit state coefficient. Deviation of impedance compensation Deviation in stimulus amplitude Based on these deviations, the algorithm control unit 31 dynamically and minutely adjusts the adjustment coefficients of the first and stimulation parameters used in steps S104 and S105 using a closed-loop feedback correction formula. For example, the corrected impedance compensation coefficient... and stimulus amplitude adjustment coefficient It can be calculated as follows:

[0039]

[0040] in, It is the closed-loop correction reference coefficient. With this, when the system detects that its adjustment result continues to deviate from the target, it can automatically adjust its internal control parameters (i.e., internal adjustment coefficients), thereby enabling the entire control system to have the adaptive ability to resist long-term drift, and thus ensuring the operating accuracy and stability of the device within its design life of several years (e.g., greater than or equal to 5 years).

[0041] Step S108: Parallel execution of security warning judgment. In each cycle of the main control process, the security warning algorithm will run in parallel; its specific details will be described in Example 3.

[0042] In summary, by cyclically executing steps S101 to S107, the method of this embodiment constitutes a complete closed-loop adaptive control system, which enables implantable devices to achieve long-term, stable, reliable and efficient collaborative operation in the complex dynamic physiological environment of the endocardium.

[0043] Example 2 This embodiment describes in detail a preferred hardware structure for an endocardial dual electrode 40. This structure provides high-quality, multi-dimensional, and synchronous physical parameter input for the effective implementation of the collaborative control method described in Embodiment 1, and is the physical basis for achieving high-precision collaborative control.

[0044] Reference Figure 2 The figure shows a schematic diagram of the structure of a single electrode unit in the endocardial dual electrode 40. The endocardial dual electrode 40 of this embodiment includes a main electrode and a secondary electrode, which are connected by a flexible bridge (not shown in the figure) with specific flexibility and length. Figure 2 (As shown in the diagram) Connection. This dual-electrode layout provides the basis for collaborative work. Each electrode unit (whether the main electrode or the sub-electrode) adopts a precise layered composite structure design, with each layer having a clear division of labor and complementary functions, from the outer layer that contacts the tissue to the inner support layer.

[0045] Specifically, the layered structure includes, from the outside in, the following: Contact layer 41: This layer is the interface between the electrode and the endocardial tissue, where electrochemical reactions and physical contact occur directly. To ensure excellent biocompatibility, corrosion resistance, and conductivity, contact layer 41 is preferably made of a platinum-iridium alloy (e.g., 90% platinum / 10% iridium). This material is stable and can effectively reduce electrode reactions and tissue inflammation, while ensuring low-loss transmission of the electrical stimulation signal. Its surface can be microporousized to increase the specific surface area, thereby reducing the electrode-tissue interface impedance.

[0046] Sensing and monitoring layer 42: This layer, located immediately inside the contact layer 41, is the core functional layer for realizing multi-dimensional physical parameter sensing. Through microfabrication technology, this layer highly integrates a series of miniature sensors. Specifically, it may include at least one microelectromechanical system (MEMS) pressure sensor 421 for directly measuring the adhesion pressure between the electrode and the endocardium. At least one miniature temperature sensor 422, such as an NTC thermistor, is used for real-time monitoring of the local operating temperature of the electrode. This is crucial for assessing tissue thermal effects and performing temperature-related impedance compensation. Furthermore, this layer integrates a method for achieving four-point measurement of contact impedance. The microelectrode, by setting a pair of driving electrodes and a pair of sensing electrodes on the contact layer 41, can accurately measure the true impedance between the electrode and the tissue, eliminating interference from wire resistance. The tensile deformation of the electrode... It can also be indirectly calculated from the data of this layer, for example, by establishing a functional model between tensile deformation and bonding pressure and contact resistance changes.

[0047] Conductive layer 43: This layer is located inside the sensing and monitoring layer 42 and is typically manufactured using flexible printed circuit board technology. Multiple independent signal paths, mutually insulated, are precisely laid out on it. One part of the paths transmits the high-current stimulation signal from the intermediate-frequency electrical stimulation module 32 to the contact layer 41; another part transmits various weak sensor signals (such as pressure, temperature, and impedance sensing signals) from the sensing and monitoring layer 42 to the algorithm control unit 31. This separate wiring design effectively avoids crosstalk and interference from the strong electrical stimulation signal to the weak sensing signal, thereby ensuring the signal-to-noise ratio and accuracy of the acquired data.

[0048] Supporting Reinforcement Layer 44: This layer is the innermost structure of the electrode, providing necessary mechanical support and overall compliance for the entire electrode tip. Its structural design requires a delicate balance between rigidity and flexibility. Internally, it may contain a micro-framework made of a bio-grade polymer such as polyetheretherketone (PEEK), which provides sufficient axial stiffness to ensure good delivery and maneuverability of the electrode during its passage through the blood vessels to the heart. Externally, a layer of more flexible, biocompatible medical-grade silicone rubber, such as polydimethylsiloxane, is wrapped around the outside. This silicone rubber layer gives the electrode tip excellent overall compliance, allowing it to gently and adaptively conform to the irregular curves of the endocardium, reducing mechanical damage to the myocardial tissue.

[0049] Furthermore, the flexible bridge connecting the main and secondary electrodes is specially designed to integrate a spacing sensor, such as a Hall effect-based sensor or a miniature optical sensor, for real-time measurement of the distance between the two electrodes. The materials and structural design of the flexible bridge itself also ensure that the two electrodes maintain a relatively stable yet slightly adaptive spacing during heartbeats.

[0050] In summary, the hierarchical, collaborative adaptive hardware structure integrating multifunctional sensors described in this embodiment can capture all the key physical parameters required by the control algorithm in Embodiment 1 in real time and synchronously, which is an important prerequisite and physical guarantee for the realization of the entire technical solution.

[0051] Example 3 This embodiment details a parallel, multi-dimensional safety early warning and emergency response mechanism in the technical solution of this application, designed to ensure the long-term operational safety of implanted devices. This mechanism corresponds to... Figure 3 Step S108 in the flowchart is executed in parallel with the main control flow, realizing the transformation from passive response to proactive prevention.

[0052] The core of this safety early warning mechanism lies in a quantitative judgment algorithm, which is executed by the algorithm control unit 31 in each calculation cycle. It integrates multiple independent real-time parameters that may indicate risk into a single, comprehensive safety early warning level coefficient through a weighted summation formula. .

[0053] In a specific implementation, the formula for quantitative judgment of safety warnings can be designed as follows:

[0054] in, , , They represent the current moment. The maximum values ​​of operating temperature, contact resistance, and bonding pressure in the main and secondary electrodes. Each of these parameters has a weighting coefficient, which sums to 1. These weights are set according to the degree of influence of different parameters on safety; for example, the weight of temperature. It may be the highest (e.g., 0.3), followed by impedance. (e.g., 0.25). is a normalization function used to map physical parameter values ​​of different units and dimensions to the interval [0, 1]. Its general form is:

[0055] in, These are real-time parameter values. and These are the preset lower and upper limits of the safety range for this parameter. These thresholds were determined based on extensive biosafety experiments and preclinical studies, such as the upper limit of the safe operating temperature. The safe upper limit for contact resistance can be set to 40℃. It can be set to 1500Ω.

[0056] Based on the calculated safety warning level coefficient The system executes a tiered response. The warning levels are divided into four levels: Level 1 Warning (Normal / Attention): This indicates that all system parameters are within the ideal range, requiring no special handling; it will only be recorded in the log. Level 2 Warning (Minor Risk): This indicates that some parameters have begun to deviate from the normal range, but have not yet posed a substantial threat. The system will increase the monitoring frequency of abnormal parameters and send a "watchlist" level status message to the external control module 10 via the wireless communication module, prompting the doctor to pay attention at the next follow-up visit. Level 3 Warning (Serious Potential Risk): This indicates that one or more key parameters are approaching or have reached a dangerous threshold, posing a high risk. The system will immediately trigger corresponding emergency actions. For example, if excessive temperature is detected, it will proactively reduce the amplitude and pulse width of the stimulation signal to decrease heat generation, while simultaneously sending a "serious warning" alarm signal to the external control module 10 and advising the patient to contact a doctor. Level 4 Warning (Emergency Danger): This indicates that the system has detected an extreme anomaly that may pose a direct threat to patient safety. For example, if the operating temperature of any electrode exceeds 40°C, or the contact resistance is greater than 1500Ω (potentially indicating electrode detachment or lead breakage) or less than 50Ω (potentially indicating a short circuit). In this case, the system will execute the highest level of emergency response: immediately cut off all electrical stimulation outputs via the control of the intermediate frequency electrical stimulation module 32, and send a highest-level alarm signal to the external control module 10 via the wireless communication module, forcibly prompting the patient to seek immediate medical attention.

[0057] To better understand the technical solution of this application, a specific working process is used as an example for illustration below: Suppose at a certain moment... Due to acute inflammation in the local tissue, the algorithm control unit 31 monitored the operating temperature of the main electrode. The temperature abnormally rose to 39.5℃, and its contact resistance also increased. The Ω also abnormally increased to 1400Ω. The algorithm control unit 31 then displays the current maximum temperature value. and maximum impedance value Substitute the parameters into the safety warning quantitative judgment formula. Assume the safety threshold is set as follows: , Weight Calculate the normalized value:

[0058]

[0059] Calculate the safety warning level coefficient (for simplicity, only the effects of temperature and impedance are considered here): Due to the calculated The value (approximately 0.493) falls within the secondary warning range [0.3, 0.6). The system classifies this state as a minor risk and accordingly increases the monitoring frequency of temperature and impedance, while sending an alert to the external device. Conversely, if the situation continues to worsen, for example, if the temperature rises to 39.8℃ or the impedance rises to 1480Ω, leading to... If the calculated value exceeds 0.6, a level 3 warning will be triggered, and the system will proactively reduce the stimulus energy and issue a higher-level alarm.

[0060] Through this quantitative and hierarchical early warning mechanism, the technical solution of this application can intervene in a timely and appropriate manner before safety hazards evolve into substantial damage, greatly improving the long-term safety of implantable devices.

[0061] Example 4 This embodiment demonstrates two important functions designed to ensure the long-term, reliable operation of implantable devices: a low-power standby and wake-up mechanism, and a redundancy fault-tolerant mechanism for dynamic switching of primary and secondary electrode roles. Both functions are intelligently scheduled and executed by the algorithm control unit 31 according to preset logical conditions.

[0062] First, this embodiment discloses a low-power standby and wake-up mechanism. Since the battery capacity of implantable devices is limited, power consumption control is crucial. The control algorithm of this application itself adopts a low-power design; for example, the calculation of all core formulas can be efficiently completed in a 16-bit fixed-point arithmetic environment, and the overall operating power consumption can be controlled below 3.5 microamps. In addition, this embodiment also designs an intelligent standby and wake-up strategy. Its working process is as follows: After the implantable myocardial contraction modulation device completes one treatment (e.g., stimulation lasting several hours), it enters a monitoring period. During this period, the algorithm control unit 31 still runs in the background, but its main task is to monitor the electrode status. If the algorithm control unit 31 continuously monitors for a preset time (e.g., 1 minute) and finds that all operating parameters of the dual electrodes are in a highly stable state, such as the dual-electrode cooperative adhesion state coefficient... If the impedance consistently exceeds a relatively high stability threshold (e.g., 0.8), and the compensated impedance fluctuations are all less than a preset fluctuation threshold (e.g., ±10Ω), the system will determine that the interaction between the device and the tissue has entered a stable equilibrium state. At this time, the system will automatically trigger to enter a low-power standby mode. In this mode, the algorithm control unit 31 will execute a series of energy-saving measures, including but not limited to: significantly extending the sensor acquisition cycle and the execution cycle of the main control loop from high frequency (e.g., 7 milliseconds) to low frequency (e.g., 100 milliseconds or longer); temporarily shutting down some non-core computing modules and peripheral interfaces; and reducing the processor clock frequency. Through these measures, the system's standby power consumption can be further reduced to below 0.5 microamps, greatly extending the battery life. The system will not remain in standby indefinitely; it will be woken up by one of the following two conditions and immediately return to full-function normal operation: 1. Receiving a wireless command from the external control module 10 to "start the next stimulation" or "force wake up"; 2. Detecting any key parameter (e.g., ...) during low-frequency periodic monitoring. If the impedance (or compensated impedance) fluctuates drastically or exceeds the preset safety range, this intelligent power management strategy minimizes energy consumption while ensuring uninterrupted safety monitoring.

[0063] Secondly, this embodiment also discloses a dynamic switching function for the roles of the primary and secondary electrodes. This function provides critical hardware redundancy for the system, aiming to improve the system's fault tolerance and reliability in the event of a single point of failure. Its working process is as follows: During a normal electrical stimulation process, the algorithm control unit 31 continuously monitors the health status of both the primary and secondary electrodes. Assuming that at a certain moment, the algorithm control unit 31 detects through the data collected in step S102 that the contact impedance of the primary electrode... The current impedance suddenly jumps from around 500Ω to over 1500Ω, and this state persists for more than three sampling cycles (approximately 21 milliseconds). The system's fault diagnosis logic determines that the main electrode has most likely experienced severe poor contact with the endocardium (detachment), or even a broken lead. At this point, the system immediately triggers an emergency plan for dynamic switching between the main and auxiliary electrode roles: 1. Internally, the algorithm control unit 31 switches the original "main electrode" to "failed / monitoring electrode" and stops assigning stimulation tasks to it. 2. Simultaneously, it smoothly switches the original "auxiliary electrode" to the new "main electrode." 3. The algorithm control unit 31 immediately re-executes steps S103 to S105 based on the real-time sensor data of the new main electrode (i.e., the original auxiliary electrode) to obtain a set of stimulation parameters suitable for the new main electrode. 4. This newly calculated set of stimulation parameters is sent to the intermediate frequency electrical stimulation module 32, which drives the new main electrode to continue electrical stimulation. The entire switching process is designed to be completed within tens of milliseconds, thus helping to ensure the continuity of myocardial contraction modulation therapy. 5. After the switching is complete, the algorithm control unit 31 sends a clear status message, such as "Main electrode malfunction, automatically switched to backup electrode, please arrange for inspection," to the external control module 10 via the wireless communication module, so that medical personnel can understand the device status and arrange subsequent treatment. Understandably, this dynamic role switching function makes the secondary electrode not only a cooperating component but also a critical redundant backup. This design greatly improves the reliability and robustness of the entire implantation system in the event of a sudden hardware failure.

[0064] 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.

[0065] 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. An implantable myocardial contraction modulation device with endocardial dual-electrode coordination, characterized in that, include: An implant body and a dual electrode, wherein the implant body is electrically connected to the dual electrode; The implant body includes an algorithm control unit and a mid-frequency electrical stimulation module; The intermediate frequency electrical stimulation module generates corresponding electrical stimulation pulses to the dual electrodes according to the instructions output by the algorithm control unit; The algorithm control unit is configured to perform the following steps and output instructions: Initialization steps: Initialize the impedance compensation adjustment coefficient and the stimulation parameter adjustment coefficient; Quantification steps of dual-electrode collaborative adhesion state: Based on multiple real-time parameters collected from the dual electrodes, the dual-electrode collaborative adhesion state coefficient, which characterizes the overall adhesion state between the dual electrodes and the endocardium, is calculated. Dual-electrode impedance co-compensation step: Based on the real-time parameters, the dual-electrode co-adhesion state coefficient, and the impedance compensation adjustment coefficient, the compensated impedance is calculated to compensate for the impedance drift of the dual electrodes; Stimulation parameter coordination adjustment step: Based on the dual-electrode coordinated fit state coefficient, the compensated impedance, and the stimulation parameter adjustment coefficient, the parameters of the electrical stimulation signal applied to the dual electrodes are dynamically and coordinatedly adjusted. Closed-loop feedback correction step: Based on the deviation between the actual output value and the corresponding target value obtained from at least one measurement characterizing the operating state or myocardial response state of the implanted myocardial contraction regulation device, the impedance compensation adjustment coefficient and the stimulation parameter adjustment coefficient are dynamically corrected.

2. The implantable myocardial contraction modulation device with endocardial dual-electrode synergy according to claim 1, characterized in that, The multiple real-time parameters collected in the dual-electrode collaborative bonding state quantification step include: bonding pressure, contact impedance, operating temperature, tensile deformation, blood flow impact pressure fluctuation, and dual-electrode spacing of each of the two electrodes.

3. The endocardial dual-electrode synergistic implantable myocardial contraction modulation device according to claim 2, characterized in that, The dual-electrode impedance collaborative compensation step specifically includes: calculating the impedance compensation amount of the main electrode and the auxiliary electrode based on the real-time contact impedance, working temperature, and blood flow impact pressure fluctuation of the dual electrodes, and in combination with the dual-electrode collaborative adhesion state coefficient.

4. The implantable myocardial contraction modulation device with endocardial dual-electrode synergy according to claim 2, characterized in that, The coordinated regulation step of the stimulation parameters specifically includes: Based on the dual-electrode synergistic fit coefficient, the compensated impedance, the deviation between the working temperature and a preset reference temperature, the distance between the dual electrodes, and the fluctuation of blood flow impact pressure, the amplitude, pulse width, and frequency of the electrical stimulation signals of the main electrode and the secondary electrode are dynamically adjusted, wherein the preset reference temperature is a pre-set reference temperature value.

5. The implantable myocardial contraction modulation device with endocardial dual-electrode synergy according to claim 3, characterized in that, The closed-loop feedback correction step specifically includes: After the stimulation parameters are adjusted in a coordinated manner, the recalculated dual-electrode coordinated fit state coefficient, the impedance compensation amount, and the actual values ​​of the stimulation parameters are collected in real time. Calculate the adjustment deviation between the actual values ​​of the dual-electrode synergistic adhesion state coefficient, the impedance compensation amount, and the stimulation parameters and their respective preset target values; Based on the adjustment deviation of the dual-electrode cooperative bonding state coefficient, the impedance compensation adjustment coefficient is dynamically adjusted; and The adjustment coefficient of the stimulation parameter is dynamically adjusted based on the impedance compensation amount and / or the adjustment deviation of the stimulation parameter.

6. The implantable myocardial contraction modulation device with endocardial dual-electrode synergy according to claim 1, characterized in that, The algorithm control unit also includes components configured to: Based on the aforementioned multiple real-time parameters, a quantitative and graded real-time safety warning is issued, and corresponding emergency procedures are performed when the warning level triggers preset conditions.

7. The implantable myocardial contraction modulation device with endocardial dual-electrode synergy according to claim 1, characterized in that, The algorithm control unit also includes components configured to: When the fluctuation of the dual-electrode collaborative bonding state coefficient and the compensated impedance within a preset time period is less than their respective preset thresholds, the system enters a low-power standby mode. as well as When a command is received or at least one of the dual-electrode cooperative bonding state coefficient or the compensated impedance is detected to exceed a preset safety range, the system is woken up from the low-power standby mode.

8. The implantable myocardial contraction modulation device with endocardial dual-electrode synergy according to claim 1, characterized in that, The algorithm control unit also includes components configured to: When an abnormal state is detected in the dual electrodes, such as open circuit, short circuit, or impedance value exceeding a preset threshold, the roles of the main and secondary electrodes are dynamically switched to ensure the continuity of electrical stimulation.

9. The endocardial dual-electrode synergistic implantable myocardial contraction modulation device according to claim 1, characterized in that, Also includes: External control module and wireless power supply module; The external control module is configured to set parameters, monitor status, and issue commands to the implant. The wireless power module is configured to provide the implant with the electrical power required for operation via wireless power transfer.

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