A targeted drug delivery system for treating children with dilated cardiomyopathy

Abstract

This invention discloses a targeted drug delivery system for treating dilated cardiomyopathy in children, relating to the field of targeted drug delivery technology. It includes a time baseline construction module, a heart rate mutation prediction module, a drug release rhythm control module, a phase-locked control module, and an energy distribution control module. The time baseline construction module establishes a unified time baseline during targeted drug delivery, integrating heart rate, blood flow velocity, and blood pressure signals in the same temporal order to generate a time reference baseline reflecting cardiac rhythm changes. This invention achieves time synchronization by establishing a unified time baseline and combining heart rate, blood flow, and blood pressure signals, ensuring that the drug release rhythm remains consistent with cardiac changes. Pre-emptive regulation is achieved through prediction windows and buffer indexes to eliminate feedback oscillations. The combination of a rhythm control table, phase-locked path, and energy distribution chain coordinates energy output with flow rate, maintaining stable and accurate drug delivery.

Description

Technical Field

[0001] This invention relates to the field of targeted drug delivery technology, and more specifically to a targeted drug delivery system for treating dilated cardiomyopathy in children. Background Technology

[0002] Targeted drug delivery systems for treating dilated cardiomyopathy in children refer to drug delivery technologies specifically designed to address the pathological characteristics of this condition, incorporating findings from medical research. The core of these systems lies in the targeted delivery of therapeutic drugs to myocardial tissue, particularly diseased cardiomyocytes or related microenvironments, through specific carrier structures, recognition mechanisms, or response mechanisms, achieving controlled release at appropriate times and locations. These systems typically consider the child's developmental stage, cardiac anatomy and metabolism, and the pathological changes in dilated cardiomyopathy, such as myocardial dilation, decreased systolic function, and myocardial remodeling. Leveraging molecular pathways and receptor distribution characteristics revealed by medical research, these systems utilize targeted ligands and physical or chemical guidance to enhance drug accumulation efficiency in the heart and reduce non-specific distribution in other tissues and organs. This approach ensures therapeutic efficacy while minimizing systemic toxicity and medication risks, resulting in safer and more precise drug treatment for dilated cardiomyopathy in children.

[0003] The existing technology has the following shortcomings: In existing technologies, drug release rates are typically adaptively adjusted using closed-loop control circuits. However, these control mechanisms suffer from inherent hysteresis and hypersensitive responses when processing dynamic physiological signals. When a patient's heart rate undergoes a sudden change, the cardiac dynamic parameters fed back by the system's real-time monitoring module momentarily deviate from the steady-state range, causing feedback oscillations in the drug release rate regulation loop due to delayed responses. Because existing feedback algorithms lack phase prediction and buffering mechanisms for heart rate mutations, the system continuously performs overcompensation-anticompensation operations within a short period, resulting in periodic self-excited oscillations and causing continuous fluctuations in the drug release rate. Furthermore, the control unit generates high-intensity energy-consuming pulses when frequently switching output states, which not only reduces the stability of the delivery system but may also lead to serious consequences such as overheating of drive components, premature aging of the drug release valve, and failure of the energy unit, thereby affecting overall treatment safety and drug efficacy accuracy.

[0004] The information disclosed in the background section is only intended to enhance the understanding of the background of this disclosure, and therefore may include information that does not constitute prior art known to those skilled in the art. Summary of the Invention

[0005] The purpose of this invention is to provide a targeted drug delivery system for treating dilated cardiomyopathy in children, thereby addressing the problems described in the background section.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a targeted drug delivery system for treating dilated cardiomyopathy in children, comprising a time baseline construction module, a heart rate mutation prediction module, a drug release rhythm control module, a phase-locking control module, and an energy distribution control module: The time baseline construction module establishes a unified time baseline during targeted drug delivery, integrating heart rate signals, blood flow velocity signals, and blood pressure signals in the same time sequence to generate a time reference baseline that reflects the rhythm of cardiac changes, which is used for time synchronization of subsequent drug release control. The heart rate mutation prediction module sets a heart rate mutation prediction window based on a unified time reference baseline. It generates a buffer index based on the changing trends of heart rate signal, blood flow velocity signal and blood pressure signal in the prediction window, forming a prediction reference for drug release time adjustment. The drug release rhythm control module establishes a drug release rhythm control table based on the buffer index, and redistributes the opening and closing times of the drug release valve within the prediction window, so that the drug release process avoids the peak segment of heart rate mutation in the time dimension. The phase-locked control module constructs a phase-locked path for the drug release rhythm based on the drug release rhythm control table, aligns the output pulse signal of the micro-pump with the cardiac rhythm, and implements flow rate limiting control according to time periods, thereby constraining the range of drug flow rate variation through time-segmented limiting. The energy distribution control module establishes an energy distribution chain based on the time segmentation and limiting results of the phase-locked path, segments the energy output of the drive unit in the time dimension, and controls the output state of the drive unit according to the timing of the energy distribution chain, thereby realizing the energy coordination control of the drug release drive process.

[0007] Preferably, the steps for constructing a time reference baseline are as follows: During the real-time monitoring phase of drug delivery, heart rate, blood flow velocity, and blood pressure signals are acquired, and the timestamps of various signals are synchronously expanded using time as the primary index. The signals are then arranged continuously according to a unified time scale, ensuring that the starting point and time interval of each signal remain consistent. After completing the signal time alignment, time gap filling is performed according to the principle of time continuity, so that the heart rate signal, blood flow velocity signal and blood pressure signal form a continuous data sequence on the same time scale, and the three types of signals are continuously connected on the time axis. After establishing a continuous time series, the heart rate signal, blood flow velocity signal, and blood pressure signal are divided into amplitudes according to the time axis arrangement order, the time series is divided into continuous rhythm units, and rhythm correlation is achieved between each rhythm unit in the time dimension. After completing the rhythm unit combination, time parameters are extracted and linearly arranged using a time series framework to generate a time reference baseline for time synchronization in the subsequent drug release control process.

[0008] Preferably, when generating the time reference baseline, the rhythmic units of the time series framework are used as the basis to maintain the time correspondence between heart rate signals, blood flow velocity signals, and blood pressure signals within the rhythmic units. The time start point, time interval, and connection sequence of each rhythmic unit are arranged continuously so that the time reference baseline accurately maps the rhythmic changes of each signal in the time dimension, and is used as a unified time reference for the drug release process.

[0009] Preferably, the buffer index generation steps are as follows: After establishing a unified time baseline, the heart rate signal, blood flow velocity signal and blood pressure signal are synchronously extracted using the time baseline as the reference axis. The continuous time reference interval is divided into multiple time sub-segments, and the start and end positions of each time sub-segment correspond to the time baseline. Using the middle position of the time sub-segment as a reference point, the time length and coverage of the prediction window are determined, and a partially overlapping prediction window is formed by time extension, so that the heart rate signal, blood flow velocity signal and blood pressure signal maintain a continuous transition in time. After forming a continuous prediction window, time correlation analysis is performed on the heart rate signal, blood flow velocity signal and blood pressure signal in each prediction window to determine the candidate start point, core region and termination segment, and then they are sequentially connected to form a buffer time index chain. The time index chains within each prediction window are mapped to a unified time baseline, and arranged in chronological order to generate a set of buffer indexes covering the entire time baseline, which serves as a prediction reference for drug release time adjustment.

[0010] Preferably, during the generation of the buffer time index chain, the temporal change direction and amplitude change of the heart rate signal, blood flow velocity signal, and blood pressure signal within the prediction window are compared in chronological order. When the three types of signals show synchronous changes in time, the corresponding time segment is marked as the starting position of the buffer, and the time segment where the signal change amplitude exceeds the range of the time baseline rhythm is determined as the core area of ​​the buffer, so as to form a continuous time index chain.

[0011] Preferably, the drug release rhythm control steps are as follows: After generating the buffer index, the start and end times of the buffer index are marked on the time axis using a unified time baseline, and a time partitioning structure is established within the time period to divide the time axis into continuous time control intervals. Based on the determined time control interval, and according to the time distribution characteristics of the buffer index, the opening and closing times of the drug release valve are reconstructed to divide the avoidance time period and the release time period and make the valve timing consistent with the time distribution of the buffer index. After completing the valve time reconstruction, the valve opening time, closing time, and buffer index number are recorded as time control groups, using time control intervals as units, and a continuous time control table is formed in chronological order. After the time control table is established, it is rhythmically mapped to the time range of the prediction window, so that the valve opening and closing time is dynamically adjusted within the prediction window, forming a drug release rhythm control table that runs through the drug delivery process.

[0012] Preferably, during the rhythm mapping process, the time control table uses the start time of the prediction window as the mapping starting point, redistributes the opening and closing times of the time control group to the corresponding prediction window according to a unified time baseline, and synchronously adjusts the valve timing while the prediction window slides, so that the drug release action maintains a phase correspondence with the cardiac rhythm in the time dimension.

[0013] Preferably, the drug release rhythm phase locking step is as follows: After the drug release rhythm control table is generated, the time records in the drug release rhythm control table are matched with the time positions of heart rate signal, blood flow velocity signal and blood pressure signal with the time baseline, so that the opening time of the drug release valve is aligned with the starting phase of the cardiac rhythm and the closing time is synchronized. After establishing the time alignment relationship between the drug release rhythm and the cardiac rhythm, the start and end times of the output pulse signal of the micro-pump are divided on the time axis using the time interval of the drug release rhythm control table as the unit, so that the time interval boundary is consistent with the valve control rhythm. After establishing a phase-locked pathway for drug release rhythm, the upper and lower limits of flow rate are set for each time period based on the time segmentation results, and a transition interval for time segmentation amplitude is established to keep the drug flow rate continuously controlled in each time period. After completing the flow rate limiting control, the upper and lower limits of flow rate and the transition interval of each time period are arranged in chronological order to form a flow rate distribution sequence. The flow rate distribution sequence is then superimposed with the drug release rhythm phase-locking path to ensure that the drug flow rate corresponds to the phase distribution of the cardiac rhythm on the time axis.

[0014] Preferably, the flow rate distribution sequence is continuously arranged according to the phase order of the cardiac rhythm during the time segmentation and amplitude limiting process. The output pulse signal of the micro-pump corresponds to the time boundary of each flow rate interval on the time axis, so that the flow rate change transitions in a time-continuous manner between adjacent time periods, thereby keeping the flow rate control of the drug release process and the phase distribution of the cardiac rhythm in time synchronization.

[0015] Preferably, the energy distribution control steps are as follows: After the phase-locking path of the drug release rhythm is determined, the time axis is divided into continuous energy control intervals based on the time segmentation and amplitude limiting results in the phase-locking path, and each energy control interval corresponds to the drug flow rate change interval in time. After the energy control zone is formed, the energy output level of the driving unit in the corresponding energy control zone is determined based on the flow rate limiting results of each time period in the phase-locked path, and the energy output intensity is kept synchronized with the time change of the drug flow rate. After determining the energy output level, all energy control intervals are connected in chronological order to form an energy distribution chain composed of continuous energy output units, and the energy distribution chain is aligned with the time period of the drug release rhythm phase-locked path on the time axis. After the energy distribution chain is established, the control drive unit enters the energy output state, energy holding state and energy transition state in sequence according to the time structure of the energy distribution chain, so that the energy release process presents a rhythmic distribution on the time axis and realizes energy coordination control.

[0016] The technical effects and advantages provided by the present invention in the above technical solution are as follows: This invention establishes a unified time baseline during drug delivery and integrates the time synchronization of heart rate, blood flow velocity, and blood pressure signals, ensuring that drug release is consistent with cardiac rhythm in the time dimension. By introducing a heart rate mutation prediction window and buffer index on the unified time baseline, the drug release rhythm has the ability to respond in advance to changes in cardiac rhythm, thereby completing valve timing and flow rate regulation before heart rate fluctuations and avoiding feedback oscillations in the drug release loop due to time lag. This method effectively improves the time coordination of the drug release process, enabling a dynamic matching relationship between drug flow rhythm and cardiac rhythm, ensuring a stable and continuous drug release rate.

[0017] This invention utilizes the synergistic effect of a drug release rhythm control table, a phase-locked path, and an energy distribution chain to ensure that the output state of the drive unit forms a unified logical chain with the drug release rhythm in time. Through time-based control of flow rate limiting and segmented energy distribution, energy output is evenly distributed across different rhythm intervals, avoiding sudden increases in energy consumption and mechanical fatigue caused by frequent switching of drive components. This structure achieves synchronous coordination between energy output and drug flow rate, ensuring stable operation of the drug delivery process in terms of time, flow rate, and energy, and guaranteeing the accuracy of drug delivery to the target tissue and therapeutic safety. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this invention. For those skilled in the art, other drawings can be obtained based on these drawings.

[0019] Figure 1 This is a schematic diagram of a targeted drug delivery system for treating dilated cardiomyopathy in children according to the present invention. Detailed Implementation

[0020] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the examples set forth herein; rather, they are provided so that the description of this disclosure will be more complete and fully convey the concept of the exemplary embodiments to those skilled in the art.

[0021] This invention provides, for example Figure 1 The targeted drug delivery system shown includes a time baseline construction module, a heart rate mutation prediction module, a drug release rhythm control module, a phase-locked control module, and an energy distribution control module for treating dilated cardiomyopathy in children. The time baseline construction module establishes a unified time baseline during targeted drug delivery, integrating heart rate signals, blood flow velocity signals, and blood pressure signals in the same time sequence to generate a time reference baseline that reflects the rhythm of cardiac changes, which is used for time synchronization of subsequent drug release control. To achieve time synchronization in the drug release control process, a unified time baseline needs to be established, ensuring that heart rate, blood flow velocity, and blood pressure signals correspond on the same time series and form a time reference baseline that reflects the rhythm of cardiac changes. The specific steps are as follows:

[0022] During the real-time monitoring phase of drug delivery, the patient's heart rate, blood flow velocity, and blood pressure signals are acquired. The timestamps of each signal type are synchronously expanded using time as the primary index, and each set of raw signals is continuously arranged according to a uniform time scale. In this process, all signals are integrated from different detection sources in chronological order, using the same time series as a reference, ensuring consistency between the starting point and time interval of each signal. This approach ensures that the heart rate, blood flow velocity, and blood pressure signals maintain a correspondence at any given time point, accurately locating the time position of each sampling point on the overall time axis.

[0023] After time alignment of the signals, time gaps are filled according to the principle of temporal continuity to address local signal interval differences in the time series, forming an uninterrupted continuous data sequence of heart rate, blood flow velocity, and blood pressure signals on the same time scale. In this step, time insertion and time interleaving are used to ensure continuous connection of the three signal streams on the same time axis, thereby eliminating time gaps caused by different sampling rates or signal acquisition delays. After this process, the three types of signals form a continuous, uniform, and traceable temporal distribution structure on the same time axis, laying the foundation for temporal integrity in the subsequent generation of the time baseline.

[0024] After establishing a continuous time series, the heart rate, blood flow velocity, and blood pressure signals are divided into amplitude segments according to their time axis arrangement, resulting in several continuous rhythm units. Each rhythm unit corresponds to one or more cycles of cardiac variability. This time partitioning method combines temporal continuity with the rhythmic characteristics of the signals, ensuring that each rhythm unit simultaneously contains time-series information on heart rate, blood flow velocity, and blood pressure. Subsequently, using the start and end positions of each rhythm unit as boundaries, it is sequentially connected with adjacent rhythm units in time, forming a complete time series framework. This ensures that various signals achieve a consistent rhythmic expression across the time dimension. Through this process, different signals form a fixed rhythmic correlation structure on the time axis, enabling the time baseline to reflect the true rhythmic changes of the heart.

[0025] After completing the continuous combination of rhythm units, the starting point, time interval, and sequential connection of each rhythm unit are extracted using a time series framework as a reference. These time parameters are then arranged linearly to generate a time reference baseline. During the generation process, the temporal correspondence between heart rate, blood flow velocity, and blood pressure signals within each rhythm unit is maintained, ensuring that the generated time reference baseline accurately maps the temporal position and rhythm of change of each signal. This time reference baseline, with time as the sole coordinate dimension, constitutes a time standard throughout the entire drug delivery process. It is used for unified reference at each time point in the subsequent drug release control phase, ensuring that the time sequence of drug release is consistent with the rhythm of cardiac activity. In this way, it is ensured that the drug release process and the rhythm of cardiac activity are corresponding in time, so that the drug release action always follows the same time reference, avoiding the impact of temporal inconsistencies of different signals on drug release control.

[0026] The heart rate mutation prediction module sets a heart rate mutation prediction window based on a unified time reference baseline. It generates a buffer index based on the changing trends of heart rate signal, blood flow velocity signal and blood pressure signal in the prediction window, forming a prediction reference for drug release time adjustment. In drug delivery, to establish a heart rate mutation prediction window reflecting the characteristics of cardiac rhythm fluctuations on a time reference baseline, and to form a predictive reference for adjusting drug release time within this window, it is necessary to perform time-domain segmentation and trend analysis on heart rate, blood flow velocity, and blood pressure signals based on a unified time baseline to generate a buffered time index structure. The specific steps are as follows:

[0027] After establishing a unified time baseline, using this baseline as the sole reference axis, synchronous time interception is performed on the heart rate, blood flow velocity, and blood pressure signals. By dividing the continuous time reference interval into several independently processable time sub-segments at equal intervals on the time baseline, each time sub-segment contains complete sequences of heart rate, blood flow velocity, and blood pressure signals. Each time sub-segment corresponds to a complete cardiac cycle or a combination of adjacent cycles. At this point, the start and end positions of each time sub-segment correspond one-to-one with the reference time points on the time baseline, thus fixing the temporal correspondence of the heart rate, blood flow velocity, and blood pressure signals. This method ensures that the temporal distribution structure of each signal remains strictly consistent with the time baseline, providing clear temporal boundaries for defining the prediction window.

[0028] After dividing the time into sub-segments, the midpoint of each sub-segment is used as the initial reference point to determine the time length and coverage of the prediction window. The time length of the prediction window is determined based on the rhythm interval of the time baseline, ensuring it covers the complete cycle of changes in heart rate, blood flow velocity, and blood pressure signals, while also including edge information from adjacent time segments to reflect the continuous trend of cardiac rhythm changes. In this process, the boundaries of each sub-segment are extended temporally, expanding the time range of the prediction window to include the end time of the previous cycle and the start time of the next cycle, thus creating an overlapping structure in time. This overlapping structure allows the heart rate, blood flow velocity, and blood pressure signals to exhibit a continuous transition state within the prediction window, enabling each prediction window to reflect the evolution of cardiac rhythm. In this way, multiple prediction windows are continuously arranged and partially overlapping on a unified time baseline, providing a continuous time reference for the subsequent generation of the buffer index.

[0029] After forming continuous prediction windows, time correlation analysis is performed on the heart rate, blood flow velocity, and blood pressure signals within each prediction window to extract temporal features reflecting the trend of cardiac fluctuations. By comparing the amplitude, direction, and time interval of signal changes between adjacent time points within the same prediction window, the trend of each signal within the time window is determined. When the heart rate, blood flow velocity, and blood pressure signals show synchronous changes or convergence in direction in time, the time position of that time segment is recorded as a candidate starting point of the buffer. When the amplitude of any of the three signals exceeds the rhythmic change range of the time baseline, its time interval is determined as the core region of the buffer. Based on this, the candidate starting point, core region, and termination segment within each prediction window are connected in chronological order to form a continuous buffer time index chain. This index chain records the temporal structure and fluctuation trend of signal changes within the prediction window, so that each prediction window corresponds to a time index set, used to characterize the distribution of time periods in which sudden changes in heart rate may occur within that window.

[0030] After forming the buffer time index chain, the time index sets within each prediction window are mapped to a unified time baseline, ensuring a unique correspondence between the time position of each buffer index and the time baseline. This ensures that the time positions of heart rate, blood flow velocity, and blood pressure signals on the time baseline align with the time periods of the buffer indexes, allowing the time index chain to fully reflect the temporal changes in cardiac rhythm. Subsequently, the time index chains of all prediction windows are arranged sequentially according to the time baseline, forming a buffer index set covering the entire time baseline. This set, with time as its core dimension, contains multiple interconnected time index segments, each corresponding to a prediction window's time period. This structure establishes a continuous time prediction reference on the unified time baseline, enabling drug release control to identify and avoid heart rate abrupt changes during time adjustment based on this time index set.

[0031] The drug release rhythm control module establishes a drug release rhythm control table based on the buffer index, and redistributes the opening and closing times of the drug release valve within the prediction window, so that the drug release process avoids the peak segment of heart rate mutation in the time dimension. To enable the opening and closing times of the drug release valves to be redistributed within the prediction window based on the buffer index, and to ensure that the drug release process avoids peak periods of heart rate fluctuations in the time dimension, a drug release rhythm control table needs to be established with the buffer index as the core reference. Through continuous steps such as time division, valve timing adjustment, and rhythm matching, a time control structure that reflects the changing patterns of cardiac rhythm is constructed. The specific steps are as follows:

[0032] After generating the buffer index, using a unified time baseline as the time axis, the start and end times of the buffer index are marked on the time axis, and a corresponding time partitioning structure is established within the time period of the buffer index. In this way, the entire time axis is divided into multiple consecutive time control intervals, each corresponding to a cardiac rhythm cycle. Each time control interval contains one or more buffer index time periods, forming a time reference frame for drug release timing planning. At this point, the boundaries of the time control intervals are correlated with the time positions of the buffer indexes, ensuring that each time interval includes time periods related to changes in cardiac rhythm. This provides clear time boundary conditions for valve opening and closing, enabling valve control to have a clearly defined adjustment range in the time dimension.

[0033] Based on the established time control intervals, the opening and closing times of the drug release valves are reconstructed using the time distribution characteristics within the buffer index. By analyzing the sequence and duration of each time segment in the buffer index, the time range that drug release should avoid in relation to the cardiac rhythm is determined. In this process, each time control interval is used as a basic unit, dividing the time range of the buffer index into avoidance and release periods. The avoidance period corresponds to the peak region of heart rate mutations, while the release period corresponds to the relatively stable region of the heart rate. Subsequently, the valve opening time is adjusted to fall within the release period, and the valve closing time is extended to before the starting boundary of the avoidance period, ensuring that the valve opening and closing actions are coordinated with the time distribution of the buffer index on the time axis. In this way, the working sequence of the drug release valves is aligned with the cardiac rhythm in terms of time distribution.

[0034] After reconstructing the valve opening and closing times, time control intervals are used as units to record the opening and closing times of each valve as time control groups. Each time control group includes an opening time point, a closing time point, and a corresponding buffer index number. These time control groups are then arranged in chronological order according to a unified time baseline, forming a continuous time control table. This time control table maintains a one-to-one correspondence with the distribution of buffer indices in time, ensuring that each entry matches a specific cardiac rhythm interval. In this process, each entry records not only the valve opening and closing times but also the duration of the time interval and the transition time between adjacent intervals, thus forming a time recording structure that reflects the rhythmicity of drug release. This structure allows for continuous planning of drug release in the time dimension, ensuring that drug release actions are sequentially linked to the cardiac rhythm.

[0035] After establishing the time control table, a rhythm mapping is performed to dynamically correspond it to the time range of the prediction window. In this process, using the starting time of the prediction window as the mapping starting point, the time positions of each time control group in the time control table are redistributed to their corresponding prediction windows according to a unified time baseline. As the prediction window slides to a new time position, the opening and closing times of each valve in the time control table shift synchronously with the prediction window, ensuring that the drug release action is always within a phase range that matches the cardiac rhythm. In this way, the time control table can dynamically reflect the drug release rhythm under different cardiac states, allowing the drug release valves to be redistributed in time according to the buffer index in each prediction window. The resulting drug release rhythm control table spans the entire drug delivery process in the time dimension, ensuring that the valve opening and closing actions are coordinated with heart rate, blood flow velocity, and blood pressure signals.

[0036] The phase-locked control module constructs a phase-locked path for the drug release rhythm based on the drug release rhythm control table, aligns the output pulse signal of the micro-pump with the cardiac rhythm, and implements flow rate limiting control according to time periods, thereby constraining the range of drug flow rate variation through time-segmented limiting. To ensure the output pulse signal of the micro-infusion pump is phase-aligned with the cardiac rhythm in time, and to implement flow rate limiting control based on time intervals, a drug release rhythm phase-locking path needs to be constructed based on the drug release rhythm control table. This ensures that the drug release action is synchronized with the cardiac rhythm in the time dimension, thereby maintaining a controlled range of drug flow rate variation across different time intervals. The specific steps are as follows:

[0037] After the drug release rhythm control table is generated, each time record in the table is mapped one-to-one with the time positions of heart rate, blood flow velocity, and blood pressure signals, using a time baseline as a reference. By calibrating the valve opening and closing times with the phase points of the cardiac rhythm on the time axis, a correspondence is established between each time period in the drug release rhythm control table and a specific phase position in the cardiac rhythm. Based on this, using the starting phase of the cardiac rhythm as a locking reference point, the opening time of the drug release valve is time-aligned with the starting phase of the cardiac rhythm, and the closing time of the drug release valve is synchronized with the phase termination position of the cardiac rhythm, ensuring that the drug release action is within the cyclical framework of the cardiac rhythm in the time dimension. In this way, a temporally continuous phase correspondence structure is formed, providing a time basis for phase locking of the output pulse signal of the micro-infusion pump.

[0038] After establishing the time alignment between the drug release rhythm and the cardiac rhythm, the output pulse signal of the micro-infusion pump is divided into time intervals using the time intervals of the drug release rhythm control table. By dividing the time axis into multiple consecutive time periods, each time period corresponds to a release interval in the drug release rhythm control table. Fixed start and end times are set for each time period to define the start and end times of the micro-infusion pump's output. During this process, the boundary positions of each time period are derived from the opening and closing times of the valves in the drug release rhythm control table, ensuring that the time sequence of the micro-infusion pump's output pulses remains synchronized with the valve control rhythm. In this way, the output pulse signal of the micro-infusion pump can form a phase correspondence with the heart rate, blood flow velocity, and blood pressure signals in time, thereby establishing a continuous drug release rhythm phase-locked path on the time axis.

[0039] After establishing a phase-locked pathway for the drug release rhythm, the range of drug flow rate variation within each time segment is limited based on the time division of this pathway. An upper limit for flow rate is set at the beginning of each time segment, and a lower limit is set at the end of the time segment, with a continuous transition interval for flow rate variation established within each time segment. This time-segmented limiting method constrains the range of drug flow rate variation within each time segment, thus preventing abrupt changes in drug flow rate within the time segment. During this process, the boundary conditions of the time-segmented limiting are consistent with the time partitions of the drug release rhythm control table, ensuring that the flow rate limiting range matches the phase interval of the cardiac rhythm. This structure allows the drug release process to both follow the changes in cardiac rhythm in time and maintain controlled flow rate variations within each time segment.

[0040] After completing the flow rate limiting control, the upper and lower limits of the flow rate and the intermediate transition intervals for each time period are recorded in chronological order as a flow rate distribution sequence. This flow rate distribution sequence, with time periods as units, forms a continuous flow rate change curve throughout the entire drug release cycle. Subsequently, this flow rate distribution sequence is superimposed on the drug release rhythm phase-locked path, ensuring a one-to-one correspondence between the drug flow rate and the phase distribution of the cardiac rhythm on the time axis. During drug release, when the micro-pump outputs pulses according to the phase-locked path, the flow rate distribution sequence acts as a limiting constraint, ensuring that the instantaneous flow rate of drug release remains within the limited range. Through this time-segmented limiting constraint method, the range of drug flow rate variation can be kept consistent with the temporal variation of the cardiac rhythm, ensuring a synchronous correspondence between the time distribution of the drug release process and the rhythmic characteristics of the cardiac cycle.

[0041] The energy distribution control module establishes an energy distribution chain based on the time segmentation and limiting results of the phase-locked path, segments the energy output of the drive unit in the time dimension, and controls the output state of the drive unit according to the timing of the energy distribution chain, thereby realizing the energy coordination control of the drug release drive process. An energy distribution chain is established based on the time-segmented limiting results of the phase-locked path, and the energy output of the drive unit is segmented and distributed in the time dimension. This requires maintaining synchronization between the drug release rhythm and the cardiac rhythm. Through a time-structured energy scheduling process, the output state of the drive unit corresponds to the range of drug flow rate changes, thus forming a time-correlated energy coordination control process. The specific steps are as follows:

[0042] After determining the phase-locked path for drug release rhythm, the time axis is divided into multiple continuous energy control intervals based on the time-segmented limiting results within the phase-locked path. Each energy control interval corresponds to a time-segmented limiting interval within the phase-locked path, ensuring that each energy control interval completely overlaps with the drug flow rate variation interval in time. By establishing this one-to-one temporal relationship on the time axis, the energy control intervals can directly inherit the time boundary conditions of the time-segmented limiting. In this process, the time baseline serves as a unified reference dimension, ensuring that the start and end times of the energy control intervals are completely consistent with the time segments of the phase-locked path. In this way, a time-centric energy allocation framework is formed, providing a temporal structural basis for the construction of the energy allocation chain, enabling continuous energy output allocation intervals on the time axis.

[0043] After establishing the energy control interval, the energy output level of the driving unit within the corresponding energy control interval is determined based on the flow rate limiting results for each time period in the phase-locked path. By analyzing the range of drug flow rate variation within each time period, the energy output amplitude and duration of the driving unit in that time period are determined. When the drug flow rate is at the upper limit of the limiting interval, the energy output level for the corresponding time period is set to a higher state; when the drug flow rate is at the lower limit of the limiting interval, the energy output level for the corresponding time period is set to a lower state. In the transition section of the limiting interval, the energy output level is stratified according to the principle of temporal continuity, so that the energy output forms a gradually changing state sequence in the time dimension. In this way, the energy output intensity of the driving unit is synchronized with the temporal change of the drug flow rate, thereby establishing a time-segmented energy output structure within each time control interval, giving the energy continuity and hierarchy in the time dimension, and providing a foundation for the temporal establishment of the energy distribution chain.

[0044] After determining the output levels of each energy control interval, all energy control intervals are connected sequentially in time to form a complete energy distribution chain. This energy distribution chain consists of multiple consecutively arranged energy output units, each corresponding to a time control interval, arranged in a time-dominant order. Each energy output unit includes the start and end times of energy output and the energy output amplitude value. All energy output units are sequentially connected, ensuring the energy distribution chain spans the entire drug release cycle. This continuous arrangement creates a rhythmic energy output structure on the time axis, corresponding one-to-one with the time periods of the drug release rhythm phase-locked path. Based on this, the energy distribution chain serves as the core basis for time-driven commands, precisely scheduling the energy release rhythm of the driving units, ensuring that the driving units output energy at set amplitudes within different time periods, thus giving the energy output process a clear temporal hierarchy.

[0045] After the energy distribution chain is established, the output state of the drive unit is controlled in time according to the temporal structure of the energy distribution chain. By using the start and end times of each time control interval in the energy distribution chain as a reference, the drive unit is controlled to sequentially enter the energy output state, energy holding state, and energy transition state in the time dimension. In the energy output state, the drive unit releases energy according to the corresponding output amplitude in the energy distribution chain; in the energy holding state, the drive unit maintains a constant energy output level to ensure the drug flow rate remains stable within the limit range; in the energy transition state, the energy output of the drive unit smoothly transitions between adjacent energy control intervals, making the energy change a continuous curve in time. Through this time-segmented energy output control, the energy release of the drive unit exhibits a periodic and rhythmic distribution on the time axis, forming a strict correspondence with the time period of the drug release rhythm phase-locked path. By combining time-segmented amplitude limiting with the energy distribution chain, the energy output process of the drive unit is synchronized with the changes in cardiac rhythm, thus forming a coordinated energy output pattern in time.

[0046] This invention establishes a unified time baseline during drug delivery and integrates the time synchronization of heart rate, blood flow velocity, and blood pressure signals, ensuring that drug release is consistent with cardiac rhythm in the time dimension. By introducing a heart rate mutation prediction window and buffer index on the unified time baseline, the drug release rhythm has the ability to respond in advance to changes in cardiac rhythm, thereby completing valve timing and flow rate regulation before heart rate fluctuations and avoiding feedback oscillations in the drug release loop due to time lag. This method effectively improves the time coordination of the drug release process, enabling a dynamic matching relationship between drug flow rhythm and cardiac rhythm, ensuring a stable and continuous drug release rate.

[0047] This invention utilizes the synergistic effect of a drug release rhythm control table, a phase-locked path, and an energy distribution chain to ensure that the output state of the drive unit forms a unified logical chain with the drug release rhythm in time. Through time-based control of flow rate limiting and segmented energy distribution, energy output is evenly distributed across different rhythm intervals, avoiding sudden increases in energy consumption and mechanical fatigue caused by frequent switching of drive components. This structure achieves synchronous coordination between energy output and drug flow rate, ensuring stable operation of the drug delivery process in terms of time, flow rate, and energy, and guaranteeing the accuracy of drug delivery to the target tissue and therapeutic safety.

[0048] The foregoing has only described certain exemplary embodiments of the present invention by way of illustration. Undoubtedly, those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the foregoing drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

Claims

1. A targeted drug delivery system for treating pediatric dilated cardiomyopathy, characterized in that, It includes a time baseline construction module, a heart rate mutation prediction module, a drug release rhythm control module, a phase-locked control module, and an energy distribution control module: The time baseline construction module establishes a unified time baseline during targeted drug delivery, integrating heart rate signals, blood flow velocity signals, and blood pressure signals in the same time sequence to generate a time reference baseline that reflects the rhythm of cardiac changes. The heart rate mutation prediction module sets a heart rate mutation prediction window based on a unified time reference baseline, and generates a buffer index based on the changing trends of heart rate signal, blood flow velocity signal and blood pressure signal within the prediction window. The drug release rhythm control module establishes a drug release rhythm control table based on the buffer index, and redistributes the opening and closing times of the drug release valves within the prediction window. The phase-locked control module constructs a phase-locked path for the drug release rhythm based on the drug release rhythm control table, aligns the output pulse signal of the micro-pump with the cardiac rhythm, and implements flow rate limiting control according to time periods, thereby constraining the range of drug flow rate variation through time-segmented limiting. The energy distribution control module establishes an energy distribution chain based on the time segmentation and limiting results of the phase-locked path, segments the energy output of the drive unit in the time dimension, and controls the output state of the drive unit according to the timing of the energy distribution chain.

2. The targeted drug delivery system for the treatment of pediatric dilated cardiomyopathy according to claim 1, wherein, The steps for constructing a time reference baseline are as follows: During the real-time monitoring phase of drug delivery, heart rate, blood flow velocity, and blood pressure signals are acquired, and the timestamps of various signals are synchronously expanded using time as the primary index, so that the signals are continuously arranged according to a unified time scale. After completing the signal time alignment, time gaps are filled according to the principle of time continuity, so that the heart rate signal, blood flow velocity signal and blood pressure signal can be formed into a continuous data sequence on the same time scale; After establishing a continuous time series, the heart rate signal, blood flow velocity signal, and blood pressure signal are divided into amplitudes according to the time axis arrangement order, the time series is divided into continuous rhythm units, and rhythm correlation is achieved between each rhythm unit in the time dimension. After completing the rhythm unit combination, time parameters are extracted with reference to the time series frame and linearly arranged to generate a time reference baseline.

3. The targeted drug delivery system for the treatment of pediatric dilated cardiomyopathy according to claim 2, wherein, When generating the time reference baseline, the rhythm units of the time series framework are used as the basis to maintain the time correspondence between heart rate signals, blood flow velocity signals, and blood pressure signals within the rhythm units. The time start point, time interval, and connection sequence of each rhythm unit are arranged continuously so that the time reference baseline accurately maps the rhythm changes of each signal in the time dimension.

4. The targeted drug delivery system for the treatment of pediatric dilated cardiomyopathy according to claim 3, wherein, The steps for generating a buffer index are as follows: After establishing a unified time baseline, the heart rate signal, blood flow velocity signal and blood pressure signal are synchronously extracted using the time baseline as the reference axis. The continuous time reference interval is divided into multiple time sub-segments, and the start and end positions of each time sub-segment correspond to the time baseline. Using the middle position of the time sub-segment as a reference point, the time length and coverage of the prediction window are determined, and a partially overlapping prediction window is formed by time extension, so that the heart rate signal, blood flow velocity signal and blood pressure signal maintain a continuous transition in time. After forming a continuous prediction window, time correlation analysis is performed on the heart rate signal, blood flow velocity signal and blood pressure signal in each prediction window to determine the candidate start point, core region and termination segment, and then they are sequentially connected to form a buffer time index chain. The time index chains within each prediction window are mapped to a unified time baseline, and then arranged in chronological order to generate a set of buffer indexes covering the entire time baseline.

5. The targeted drug delivery system for the treatment of pediatric dilated cardiomyopathy according to claim 4, wherein, During the generation of the buffer time index chain, the temporal change direction and amplitude changes of heart rate signal, blood flow velocity signal and blood pressure signal within the prediction window are compared in chronological order. When the three types of signals show synchronous changes in time, the corresponding time segment is marked as the starting position of the buffer, and the time segment where the signal change amplitude exceeds the range of the time baseline rhythm is determined as the core area of ​​the buffer, so as to form a continuous time index chain.

6. The targeted drug delivery system for the treatment of pediatric dilated cardiomyopathy according to claim 5, wherein, The steps for controlling the drug release rhythm are as follows: After generating the buffer index, the start and end times of the buffer index are marked on the time axis using a unified time baseline, and a time partitioning structure is established within the time period to divide the time axis into continuous time control intervals. Based on the determined time control interval, and according to the time distribution characteristics of the buffer index, the opening and closing times of the drug release valve are reconstructed to divide the avoidance time period and the release time period and make the valve timing consistent with the time distribution of the buffer index. After completing the valve time reconstruction, the valve opening time, closing time, and buffer index number are recorded as time control groups, using time control intervals as units, and a continuous time control table is formed in chronological order. After the time control table is established, it is rhythmically mapped to the time range of the prediction window, so that the valve opening and closing time is dynamically adjusted within the prediction window, forming a drug release rhythm control table that runs through the drug delivery process.

7. The targeted drug delivery system for the treatment of pediatric dilated cardiomyopathy according to claim 6, wherein, During the rhythm mapping process, the time control table uses the start time of the prediction window as the mapping starting point, redistributes the opening and closing times of the time control group into the corresponding prediction window according to a unified time baseline, and synchronously adjusts the valve timing while the prediction window slides, so that the drug release action maintains a phase correspondence with the cardiac rhythm in the time dimension.

8. The targeted drug delivery system for the treatment of pediatric dilated cardiomyopathy according to claim 6, wherein, The drug release rhythm phase locking steps are as follows: After the drug release rhythm control table is generated, the time records in the drug release rhythm control table are matched with the time positions of heart rate signal, blood flow velocity signal and blood pressure signal with the time baseline, so that the opening time of the drug release valve is aligned with the starting phase of the cardiac rhythm and the closing time is synchronized. After establishing the time alignment between the drug release rhythm and the cardiac rhythm, the start and end times of the output pulse signal of the micro-pump are divided on the time axis using the time interval of the drug release rhythm control table as the unit. After establishing a phase-locked pathway for drug release rhythm, the upper and lower limits of flow rate are set for each time period based on the time segmentation results, and a transition interval for time segmentation amplitude is established to keep the drug flow rate continuously controlled in each time period. After completing the flow rate limiting control, the upper and lower flow rate limits and transition intervals of each time period are arranged in chronological order to form a flow rate distribution sequence, and the flow rate distribution sequence is superimposed with the drug release rhythm phase locking path.

9. The targeted drug delivery system for the treatment of pediatric dilated cardiomyopathy according to claim 8, wherein, The flow rate distribution sequence is continuously arranged according to the phase order of the cardiac rhythm during the time segmentation and amplitude limiting process. The output pulse signal of the micro-pump corresponds to the time boundary of each flow rate interval on the time axis, so that the flow rate change transitions in a time-continuous manner between adjacent time periods, thereby keeping the flow rate control of the drug release process in time synchronized with the phase distribution of the cardiac rhythm.

10. The targeted drug delivery system for the treatment of pediatric dilated cardiomyopathy according to claim 8, wherein, The energy distribution control steps are as follows: After the phase-locking path of the drug release rhythm is determined, the time axis is divided into continuous energy control intervals based on the time segmentation and amplitude limiting results in the phase-locking path, and each energy control interval corresponds to the drug flow rate change interval in time. After the energy control zone is formed, the energy output level of the driving unit in the corresponding energy control zone is determined based on the flow rate limiting results of each time period in the phase-locked path, and the energy output intensity is kept synchronized with the time change of the drug flow rate. After determining the energy output level, all energy control intervals are connected in chronological order to form an energy distribution chain composed of continuous energy output units, and the energy distribution chain is aligned with the time period of the drug release rhythm phase-locked path on the time axis. After the energy distribution chain is established, the control drive unit enters the energy output state, energy holding state and energy transition state in sequence in the time dimension according to the timing structure of the energy distribution chain.

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