Heart premature beat detection device and method, ventricular assist system, storage medium and equipment

By collecting the speed data and pressure sensor data of the ventricular assist device, independently judging premature beats and automatically adjusting the device parameters, the problem that the ventricular assist device cannot independently detect premature beats is solved, and real-time, accurate premature beat detection and risk reduction are achieved.

CN120604977APending Publication Date: 2025-09-09SHANGHAI PHIGINE MEDICAL CO LTD

Patent Information

Application Number
CN202510664550.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-05-21
Publication Date
2025-09-09

AI Technical Summary

Technical Problem

Existing ventricular assist devices cannot detect premature beats independently and require the use of external equipment, which increases the complexity of detection and is limited in certain clinical scenarios, making it impossible to detect premature beats in a timely and accurate manner.

Method used

By collecting the speed data of the drive motor in the ventricular assist device and combining the relationship between the maximum speed, the historical average maximum speed and the gear speed, the occurrence of premature beats can be independently judged. When premature beats are detected, the device gear can be automatically adjusted and an alarm can be issued. Double verification can also be performed in combination with pressure sensor data.

Benefits of technology

It realizes the real-time detection of premature beats without the need for external monitoring equipment, simplifies the detection process, improves the accuracy and reliability of detection, and reduces surgical risks.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to a heart premature beat detection device and method, a ventricular assist system, a storage medium and equipment, and the detection device comprises a first sampling module which is configured to collect operation data of a drive motor in a ventricular assist device, and the operation data at least comprise rotation speed data; the calculation module is configured to determine a current rotating speed maximum value and a historical average maximum value according to the rotating speed data; the judgment module is configured to judge that premature beat occurs when the current rotating speed maximum value is larger than the gear rotating speed and smaller than the historical average maximum value. Compared with a traditional premature beat detection mode, premature beat detection can be carried out in real time in the operation process of the percutaneous ventricular auxiliary device, and traditional external monitoring equipment such as electrocardiogram or color Doppler ultrasound does not need to be relied on any more.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical devices for cardiac surgery, and in particular to a premature heart beat detection device, method, ventricular assist system, storage medium and equipment. Background Art

[0002] pVAD, or percutaneously inserted ventricular assist device, is a small blood pump that is inserted percutaneously into the ventricle in an interventional manner (femoral artery, etc.) to increase blood flow, enhance blood perfusion, reduce myocardial oxygen consumption, and help patients with acute heart failure enhance their heart pumping function in the short term. It is suitable for acute myocarditis with poor response to conventional treatment, cardiomyopathy with shock, refractory heart failure, cardiogenic shock caused by AMI, and perioperative support for high-risk PCI.

[0003] During the operation of the pVAD device, real-time monitoring of arrhythmias (especially premature beats) is crucial to the safety of patients. Specifically, premature beats refer to abnormal heart rhythm caused by premature contraction of heart muscles in the normal heartbeat sequence. They are commonly seen during surgery when stimulated by drugs or surgical operations / surgical equipment operation.

[0004] Currently, clinical detection of premature beats mainly relies on long-term electrocardiogram (ECG) monitoring or real-time color Doppler ultrasound (CDUS) monitoring. However, these traditional monitoring methods have significant limitations in certain clinical scenarios. For example, ECG electrodes may not be suitable for patients with exposed chest wounds. During surgery, the use of conventional monitoring equipment is also limited due to limited operating space or equipment interference. In addition, a single monitoring technology may lead to monitoring delays or errors in complex clinical environments, making it impossible to detect premature beats in a timely and accurate manner.

[0005] Based on the above reasons, how to fully utilize the data characteristics of the pVAD device itself to perform real-time detection of premature beats has become a technical problem that urgently needs to be solved. Summary of the Invention

[0006] In view of this, embodiments of the present invention provide a premature heart beat detection device, method, ventricular assist system, storage medium and equipment to solve the problems existing in the prior art.

[0007] The present invention adopts the following technical solutions:

[0008] In a first aspect, an embodiment of the present invention provides a device for detecting premature heart beats, comprising:

[0009] a first sampling module configured to collect operating data of a drive motor in the ventricular assist device, the operating data including at least rotational speed data;

[0010] a calculation module configured to determine a current maximum speed value and a historical average maximum speed value based on the speed data;

[0011] The judgment module is configured to determine that premature beats occur when the current maximum speed value is greater than the gear speed and less than the historical average maximum value.

[0012] In a second aspect, an embodiment of the present invention provides a method for detecting premature heart beats, comprising:

[0013] collecting operating data of a drive motor in a ventricular assist device, the operating data including at least speed data;

[0014] According to the speed data, determine the current maximum speed value and the historical average maximum speed value;

[0015] When the current maximum speed is greater than the gear speed and less than the historical average maximum, it is determined that premature beats have occurred.

[0016] In a third aspect, an embodiment of the present invention provides a ventricular assist system, comprising a drive motor and the premature heart beat detection device as described above.

[0017] In a fourth aspect, an embodiment of the present invention provides a computer-readable storage medium, wherein the storage medium stores at least one instruction, and the at least one instruction is loaded by a processor and executed to implement the premature heart beat detection method as described above.

[0018] In a fifth aspect, an embodiment of the present invention provides an electronic device, comprising a processor and a memory, wherein the memory stores at least one instruction, and the instruction is loaded and executed by the processor to implement the method for detecting premature heart beats as described above.

[0019] One embodiment of the above invention has the following advantages or beneficial effects:

[0020] The present invention mainly provides a device, method, ventricular assist system, storage medium and equipment for detecting premature heart beats, which can detect premature beats in real time during the operation of a percutaneous ventricular assist device, without relying on external monitoring equipment such as traditional electrocardiograms or color Doppler ultrasound. Compared with traditional premature beat detection methods, the present invention has obvious advantages for various special clinical scenarios where electrocardiograms cannot be used. The detection device provided by the embodiment of the present invention can continuously monitor premature beats without being restricted by the environment or the patient's pathological condition.

[0021] Specifically, the present invention collects speed data from the ventricular assist device's drive motor and independently determines the presence of premature beats by combining the relationship between maximum speed, historical average maximum speed, and gear speed, without relying on pressure sensor data. This solves the problem of premature beat detection in situations where the pressure sensor is faulty or absent. When a premature beat is detected, the device automatically lowers the assist device gear and issues an alarm, prompting the physician to closely monitor the patient's other physiological conditions, effectively reducing surgical risk.

[0022] The present invention also provides a comprehensive judgment mechanism that incorporates pressure sensor data. When a pressure sensor is present in a ventricular assist device and is functioning properly, the device provided by this embodiment can simultaneously analyze both pressure and speed data, improving the accuracy of premature beat detection through dual verification and providing more accurate reference information to medical personnel. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are provided to explain the present invention and do not constitute an undue limitation of the present invention. In the drawings:

[0024] Figure 1 A structural block diagram of a premature heart beat detection device provided by one embodiment of the present invention;

[0025] Figure 2 A schematic diagram of the rotational speed data of a catheter pump provided by one embodiment of the present invention;

[0026] Figure 3 A structural block diagram of a premature heart beat detection device provided by another embodiment of the present invention;

[0027] Figure 4 A schematic diagram of aortic pressure data acquired by a pressure sensor provided by one embodiment of the present invention;

[0028] Figure 5 A comparison chart of aortic pressure and speed data within the same time period provided by one embodiment of the present invention;

[0029] Figure 6 A flowchart of a method for detecting premature heart beats provided by one embodiment of the present invention;

[0030] Figure 7 A specific flow chart of a method for detecting premature heart beats provided by one embodiment of the present invention;

[0031] Figure 8 A flowchart of a method for detecting premature heart beats provided in another embodiment of the present invention;

[0032] Figure 9 A specific flow chart of a method for detecting premature heart beats provided in another embodiment of the present invention. DETAILED DESCRIPTION

[0033] To make the objectives, technical solutions, and advantages of the present invention more clear, the technical solutions of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally used in the sense of including "and / or" unless the content clearly indicates otherwise.

[0034] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. In addition, in the description of this application, the terms "first," "second," etc. are used only to distinguish descriptions and should not be understood to indicate or imply relative importance.

[0035] Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0036] The percutaneous ventricular assist device (pVAD) (hereinafter referred to as the ventricular assist device) is an important instrument in the transitional stage of treatment and transplantation surgery for patients with severe heart failure. In a preferred embodiment, the structure of the ventricular assist device includes a transvalvular catheter pump and an external control device. The catheter pump can be percutaneously inserted into the ventricle in an interventional manner to increase blood flow, enhance blood perfusion, reduce myocardial oxygen consumption, and help patients with acute heart failure enhance their cardiac pumping function in the short term. However, during the operation of the catheter pump, the patient may experience premature beats due to stimulation. In order to avoid complications caused by premature beats, it is necessary to detect premature beats in a timely manner and adjust the operating parameters of the catheter pump in a timely manner after detecting premature beats to ensure the patient's safety during the operation. However, existing ventricular assist devices cannot independently detect the occurrence of premature beats and must rely on other external equipment for auxiliary detection, which increases the complexity of the detection. In addition, due to limited operating space or equipment interference, the application of conventional detection equipment is often limited.

[0037] In order to solve the above problems, the embodiment of the present invention provides a device for detecting premature heart beats. Figure 1 The detection device includes at least a first sampling module 11, a calculation module 12 and a judgment module 13, wherein the first sampling module 11 is configured to collect operating data of the drive motor in the ventricular assist device; the calculation module 12 is configured to determine the current maximum speed and the historical average maximum value based on the speed data; the judgment module 13 is configured to determine that premature beats have occurred if the current maximum speed is greater than the gear speed and less than the historical average maximum value.

[0038] In a preferred embodiment, the operating data may be selected from the speed data or current data of the drive motor. Those skilled in the art will appreciate that, in the operating characteristics of the drive motor of a ventricular assist device, both speed data and current data can reflect cardiac activity and hemodynamic changes. When premature beats occur, the ventricles contract prematurely without sufficient filling, resulting in reduced blood output. At this time, the load on the drive motor changes accordingly, manifesting as both speed fluctuations and current changes. Compared to current data, speed data responds more directly and stably to cardiac activity and is less susceptible to external interference. Therefore, in this embodiment, the operating data preferably uses the speed data of the drive motor.

[0039] In a preferred embodiment, the first sampling module 11 is configured to collect the speed data of the driving motor at a first preset sampling interval, where the first preset sampling interval is no longer than the duration of one cardiac cycle.

[0040] In a preferred embodiment, the first preset sampling interval of the first sampling module 11 is set to 10-100ms. If the sampling interval is too short, higher-precision data can be obtained, but it will occupy more system memory and increase calculation time. If the sampling interval is too long, while it can reduce the system burden, it may cause subsequent calculations to be inaccurate. To achieve a balance between system resources and data accuracy, the first preset sampling interval is preferably set to 20ms.

[0041] In a preferred embodiment, the first sampling module 11 is further configured to perform necessary filtering on the collected speed data to eliminate noise interference. Specifically, during the operation of the catheter pump, speed data may be affected by various interference factors. By implementing an appropriate filtering algorithm, unnecessary data fluctuations can be effectively eliminated to extract speed variation trends that truly reflect cardiac activity. In this embodiment, no specific filtering algorithm is specified; those skilled in the art may select an appropriate algorithm based on their implementation requirements.

[0042] Preferably, the calculation module 12 processes the speed data by configuring a sliding window. The length of the sliding window is preferably set to include data of the past 20 maximum speed values ​​R. After the calculation module 12 obtains all the maximum speed values ​​R in the sliding window, it can further calculate the historical average maximum speed value R in the sliding window. H In addition, the calculation module 12 can also simultaneously determine the current maximum speed value R1 and the gear speed R0.

[0043] Specifically, the gear speed R0 refers to the basic working speed set by the catheter pump during the treatment process. This parameter is pre-set by the clinician according to the patient's specific condition, hemodynamic needs and treatment goals. It is the benchmark value for the ventricular assist device to provide stable blood circulation support. Ventricular assist devices usually provide multiple gear options, each gear corresponds to a different speed range to adapt to different degrees of cardiac function assistance needs. Under normal cardiac function, the speed range should be maintained within the gear speed R0 ± 800 range, showing a relatively stable fluctuation characteristic. Figure 2 The red box indicates the speed data waveform when premature beats occur, and the red straight line is the gear speed R0.

[0044] Because premature beats can lead to insufficient ventricular filling, the systolic blood return volume is reduced, which makes the maximum speed lower than the historical average. Therefore, preferably, when the judgment module 13 judges that R1>R0, and R1<R H , then this speed feature can be used as the basis for judging premature beats. Among them, R1>R0 indicates that the heart has indeed contracted at this time, R1<R H This indicates that there is less blood when the heart contracts.

[0045] In a preferred embodiment, the calculation module 12 is further configured to determine a speed determination threshold value based on the gear speed and the historical average maximum value; the judgment module 13 is further configured to determine that a premature beat occurs if the current maximum speed value is greater than the gear speed and less than the speed determination threshold value. Preferably, the speed determination threshold value is set to the gear speed R0 and the historical average maximum value R H The middle value of the speed judgment threshold is (1 / 2)×(R H +R0).

[0046] Specifically, when premature beats occur, the ventricular diastole is shortened, resulting in incomplete filling and a significant reduction in cardiac output. However, the heart does not completely lose its pumping function. This partial pumping state puts the blood circulation resistance in a transitional state. Based on clinical data analysis and mathematical model verification, it is known that the maximum speed in this transitional state is typically distributed between R0 and R H Therefore, taking the average of the two as the judgment threshold can more effectively and accurately capture the premature beat characteristics, forming R0 <R1<(1 / 2)×(R H +R0) further improves the sensitivity and specificity of the detection.

[0047] In a preferred embodiment, the calculation module 12 is further configured to determine the first maximum speed value after the current maximum speed value. The judgment module 13 is further configured to determine that a premature beat has occurred when the first maximum speed value is greater than the historical average maximum value. In this case, the first maximum speed value after the current maximum speed value R1 is defined as R2.

[0048] Specifically, after the premature beat occurs, the ventricle fails to complete a complete blood filling period, resulting in a decrease in the amount of blood discharged, making the current maximum speed R1 < R H However, due to the fact that part of the blood is pumped out, less blood accumulates in the ventricles during premature beats. In the subsequent cardiac contraction, since the blood was not completely discharged in the previous contraction, more blood accumulates in the ventricles in the next contraction. Therefore, the amount of blood discharged increases, resulting in a higher blood volume than usual. As a result, the first maximum speed value R2 that follows is greater than the average maximum value R H , that is, R2>R H .

[0049] In a preferred embodiment, the detection device further includes a control module 14 and an alarm module 15. Preferably, the control module 14 is configured to generate a control instruction to lower the gear of the ventricular assist device based on the premature beat determination result of the determination module 13. Preferably, the alarm module 15 is configured to generate an alarm prompt based on the premature beat determination result of the determination module 13.

[0050] Specifically, the gear of the VAD refers to the speed or power level of the catheter pump. When a premature beat event is detected, the control module 14 triggers the VAD to temporarily reduce one or more gears, reducing the pump speed or output power to accommodate the abnormal hemodynamic state of the heart during the premature beat, reduce clinical risks, and ensure that the VAD is compatible with the patient's heart condition.

[0051] Specifically, when the judgment module 13 confirms the occurrence of premature beats, the alarm module 15 can generate various forms of alarm prompts, including but not limited to sound alarms, visual prompts, tactile feedback or remote notifications. The severity of the alarm prompts can be dynamically adjusted according to the frequency and duration of premature beats, so that medical staff can understand the patient's heart rate status in a timely manner.

[0052] In this embodiment, the detection device can realize the real-time monitoring function of premature beats by acquiring and analyzing the rotational speed data of the catheter pump, without relying on traditional external monitoring equipment such as electrocardiogram or color ultrasound, thereby simplifying the process of premature beat detection; in addition, the premature beat detection algorithm based on rotational speed characteristics has a small amount of calculation and a fast response speed, and can trigger a response mechanism immediately after the premature beat occurs, so as to adjust the treatment strategy in time.

[0053] In a preferred embodiment, the catheter pump is also integrated with a pressure sensor for real-time collection of intravascular pressure change data. This data includes systolic and diastolic pressure information, which directly reflects the systolic and diastolic state of the heart and hemodynamic parameters. When premature beats occur, the characteristics of the diastolic pressure drop and subsequent systolic pressure increase caused by insufficient ventricular filling can serve as an important basis for determining premature beats. Therefore, preferably, the detection device of the present invention can further include a second sampling module 16, such as Figure 3 Second sampling module 16 is configured to collect data from the pressure sensor in the ventricular assist device. By acquiring and analyzing the pressure sensor data and combining it with the catheter pump speed data, the detection device can detect premature beats based on multiple parameters, further improving the accuracy and reliability of the detection.

[0054] Through the complementary verification of the speed data of the catheter pump in the ventricular assist device and the pressure sensor data, not only can the misjudgment rate caused by a single detection method be reduced, but also redundant protection can be provided when a certain sensor system fails, thereby ensuring the continuity, stability and reliability of the detection function.

[0055] Preferably, the second sampling module 16 is further configured to collect pressure sensor data at a second preset sampling interval, where the second preset sampling interval is no longer than the duration of one cardiac cycle. Preferably, the second preset sampling interval has the same optional interval as the first preset sampling interval, both of which are 10-100ms. In order to achieve a balance between system resources and data accuracy, and at the same time have time synchronization with the speed data obtained by the first sampling module 11, as shown in FIG. Figure 5 , so the second preset sampling interval is preferably set to 20ms.

[0056] In a preferred embodiment, the second sampling module 16 is further configured to perform necessary filtering processing on the collected pressure sensor data to eliminate noise interference.

[0057] In a preferred embodiment, the calculation module 12 is further configured to determine the real-time heart rate and the heart rate reference value, as well as the pressure extreme value and the pressure reference value according to the pressure sensor data.

[0058] Preferably, the calculation module 12 is further specifically configured to: identify adjacent extreme points based on pressure sensor data; determine the time interval between adjacent extreme points; determine the real-time heart rate based on the time interval; and determine the heart rate reference value based on historical heart rate data.

[0059] Optionally, the adjacent extreme value points identified by the calculation module 12 are adjacent pressure maximum value points or adjacent pressure minimum value points.

[0060] like Figure 4, is a schematic diagram of the aortic pressure data obtained by the pressure sensor, wherein the waveform is the aortic pressure data, the peaks and troughs marked with black circles are the pressure data when premature beats occur, and the two blue lines are the systolic pressure reference value and the diastolic pressure reference value, respectively. During the heart's pumping and blood circulation process, if there are two consecutive premature beats, the maximum point when the second premature beat occurs may not exceed the average value. If the maximum point is determined first, omissions may occur, resulting in errors in the real-time heart rate calculation. The minimum point of the pressure waveform has more stable characteristics. Selecting the minimum pressure point as the reference point for heart rate calculation can improve the calculation accuracy. Therefore, preferably, the calculation module 12 prioritizes identifying the minimum pressure point, that is, the lowest point of diastolic blood pressure.

[0061] Preferably, the calculation module 12 identifies the time interval between two adjacent minimum points, which corresponds to a complete cardiac cycle. If the time interval between the two minimum points is t (in seconds), the real-time heart rate a (in beats per minute) can be calculated using the formula a = 60 / t. By analyzing multiple consecutive cardiac cycles, the calculation module 12 can obtain a set of heart rate data A, where each element represents the real-time heart rate data at a specific moment.

[0062] Preferably, the calculation module 12 statistically analyzes the numerical distribution in the heart rate data set A and identifies the heart rate value with the highest frequency as the reference heart rate a0. The reference heart rate a0 reflects the patient's dominant heart rhythm state over a period of time and can be used as a benchmark value for judging abnormal changes in heart rate.

[0063] Preferably, the calculation module 12 is capable of continuously updating the heart rate data set A so as to remove outdated data and incorporate newly calculated real-time heart rates, ensuring that the reference heart rate a0 can dynamically adapt to slow changes in the patient's heart rhythm state.

[0064] In a preferred embodiment, the pressure reference value determined by the calculation module 12 includes a systolic pressure reference value and a diastolic pressure reference value. Preferably, the calculation module 12 is further configured to: determine the systolic pressure reference value based on the average of multiple historical maximum pressure values; and determine the diastolic pressure reference value based on the average of multiple historical minimum pressure values.

[0065] Specifically, the calculation module 12 dynamically monitors the pressure sensor data from the sampling module and continuously records the data of the extreme points in the pressure waveform. Those skilled in the art will understand that in a blood pressure waveform, the maximum pressure corresponds to the highest blood pressure point during the heart's contraction period, i.e., the systolic pressure, while the minimum pressure corresponds to the lowest blood pressure point during the heart's relaxation period, i.e., the diastolic pressure.

[0066] Preferably, the calculation module 12 processes the pressure data by configuring a sliding window, the length of which is preferably set to include data from the past 20 cardiac cycles. For the diastolic pressure reference value, the calculation module 12 calculates the average value of the past 20 minimum pressure values, which is defined as P L0 , which is used as the diastolic pressure reference value for judging abnormal diastolic pressure; for the systolic pressure reference value, the calculation module 12 calculates the average value of the past 20 maximum pressure values, which is defined as P H0 This value is used as the systolic blood pressure reference value for judging abnormal systolic blood pressure.

[0067] Furthermore, the calculation module 12 is further configured to determine a preset threshold value, wherein the preset threshold value includes a first preset threshold value and a second preset threshold value, the first preset threshold value is determined based on the diastolic pressure reference value, and the second preset threshold value is determined based on the systolic pressure reference value.

[0068] In a preferred embodiment, when determining the first preset threshold, the calculation module 12 takes the diastolic pressure reference value P L0 Subtract a preset offset, preferably 5 mmHg, that is, the first preset threshold is set to P L0 -5 (mmHg). Specifically, the setting of this offset is based on clinical observations, namely that within the normal heartbeat fluctuation range, the instantaneous change in diastolic blood pressure usually does not fall below the reference value by more than 5 mmHg; however, when premature beats occur, due to the shortened ventricular diastole and insufficient filling, diastolic blood pressure often decreases significantly.

[0069] In a preferred embodiment, the calculation module 12 takes the systolic pressure reference value P as the second preset threshold value. H0 Add a preset offset, preferably 5 mmHg, that is, the second preset threshold is set to P H0 +5 (mmHg). Specifically, the offset setting is also based on clinical data analysis. In a compensatory heartbeat following a premature beat, the prolonged filling time of the previous heartbeat and increased ventricular filling volume generate a stronger contractile force, causing systolic blood pressure to be significantly higher than normal.

[0070] It should be noted that when determining the first preset threshold and the second preset threshold, the preset offset in the calculation module 12 is not fixed, and those skilled in the art can make personalized adjustments based on the blood pressure baseline level, blood pressure fluctuation range and clinical sensitivity requirements of different patients.

[0071] In a preferred embodiment, the judgment module 13 is further configured to: comprehensively determine the occurrence of premature beats when the real-time heart rate is less than the heart rate reference value and the pressure extreme value deviates from the pressure reference value by more than a preset threshold.

[0072] The judgment module 13 receives the real-time heart rate data, the heart rate reference value, the extreme pressure value data, the pressure reference value, the first preset threshold value, and the second preset threshold value from the calculation module 12, and performs premature beat judgment based on the multiple parameters. Specifically, when the judgment module 13 is configured to judge premature beats based on the real-time heart rate and the extreme pressure value, the judgment criteria for the real-time heart rate are: the real-time heart rate is less than the heart rate reference value, and the real-time heart rate and the heart rate reference value satisfy a=ka0, where k is 0.4 to 0.6.

[0073] In a preferred embodiment, the ratio of the real-time heart rate to the heart rate reference value is set to 2×a=a0±10, meaning that the real-time heart rate is approximately half the reference heart rate. The pressure extreme value determination criterion is: when a minimum pressure value is detected to be lower than a first preset threshold, and the first subsequent maximum pressure value is higher than a second preset threshold, the pressure extreme value is determined to have deviated from the pressure reference value by more than the preset threshold.

[0074] Specifically, when premature beats occur, the normal heart rhythm will be interrupted, causing the real-time heart rate to drop significantly in a short period of time. Therefore, when the judgment module 13 makes a premature beat judgment based on the real-time heart rate, it first compares the relationship between the real-time heart rate a and the reference heart rate a0. When a≥a0 is detected and a=ka0 (k is 0.4~0.6), the judgment module 13 preliminarily identifies the possible premature beat characteristics; or, when a≥a0 is detected and 2×a=a0±10, the judgment module 13 preliminarily identifies the possible premature beat characteristics.

[0075] After making a judgment based on the real-time heart rate, the judgment module 13 further analyzes the extreme value characteristics of the pressure waveform. At this time, the judgment module 13 detects the minimum pressure value P of the current cardiac cycle. L , if P L <P L0 If the diastolic pressure is -5, the first pressure condition for premature beat determination is met. This significantly lowered diastolic pressure reflects the hemodynamic changes caused by insufficient ventricular filling and weakened contractility due to premature beats. At this time, the aorta does not have enough ventricular blood supply, so the diastolic pressure is lower than usual.

[0076] Furthermore, the judgment module 13 will also track and analyze the first maximum pressure value P H , if P H >P H0 +5, then the second pressure condition for premature beats is met. This is because after a premature beat occurs, more blood accumulates in the ventricles, increasing blood output and causing the subsequent systolic pressure to be higher than usual.

[0077] When the real-time heart rate characteristics and the two pressure characteristics meet the premature beat judgment conditions at the same time, the judgment module 13 can confirm that a premature heart beat has occurred to avoid misjudgment, so that the detection device can accurately distinguish between true premature beats and other physiological factors that cause blood pressure fluctuations, such as respiratory changes, changes in body position, etc.

[0078] In this embodiment, through the above-mentioned hierarchical progressive judgment mechanism, the detection device achieves high-precision identification of premature beats. Regardless of whether there is a pressure sensor or whether the pressure sensor fails, the detection device can provide reliable premature beat monitoring function, thereby minimizing the clinical risks that may be caused by premature beat events.

[0079] Specifically, the first sampling module 11, calculation module 12, judgment module 13, control module 14, alarm module 15, second sampling module 16 and other functional modules in the above embodiments are all integrated into the extracorporeal control device of the ventricular assist device. As the execution subject, the extracorporeal control device obtains feedback signals from the catheter pump drive motor and pressure sensor through the data interface, executes the premature beat detection described in the embodiments of the present invention, and dynamically adjusts the working parameters of the ventricular assist device according to the detection results, and at the same time issues corresponding alarms on the human-computer interaction interface.

[0080] An embodiment of the present invention further provides a ventricular assist system, which includes a ventricular assist device and an external control device. The premature beat detection device is integrated into the external control device, and its corresponding functional modules are implemented through a software program.

[0081] refer to Figure 6 、 Figure 7 One embodiment of the present invention further provides a method for detecting premature heart beats for a ventricular assist device, the method comprising the following steps:

[0082] Step S220 , collecting operating data of the drive motor in the ventricular assist device, where the operating data at least includes speed data.

[0083] In a preferred embodiment, the operating data may be selected from the speed data or current data of the drive motor. Since speed data responds more directly and stably to cardiac activity and is less affected by external factors, in this embodiment, the operating data preferably uses the speed data of the drive motor.

[0084] In a preferred embodiment, the speed data of the drive motor is collected at a first preset sampling interval, and the first preset sampling interval is no longer than the duration of a cardiac cycle. Preferably, the first preset sampling interval is set to 10-100 ms. To achieve a balance between system resources and data accuracy, the first preset sampling interval is preferably set to 20 ms.

[0085] Preferably, after the rotation speed data is obtained, it needs to be filtered to eliminate noise interference.

[0086] Step S240: Determine the current maximum speed value, the historical average maximum speed value, and the gear speed based on the speed data.

[0087] In a preferred embodiment, the speed data is processed by setting a sliding window, and the sliding window is preferably set to include data of the past 20 maximum speed values ​​R. After obtaining all the maximum speed values ​​R in the sliding window, the historical average maximum speed value R in the sliding window can be further calculated. H At the same time, the current maximum speed R1 and the gear speed R0 are determined. Gear speed R0 refers to the basic operating speed set by the catheter pump during treatment. This parameter is pre-set by the clinician based on the patient's specific condition, hemodynamic needs, and treatment goals. It is the baseline value for the ventricular assist device to provide stable blood circulation support. Under normal cardiac function, the speed range should be maintained within the gear speed R0 ± 800, showing a relatively stable fluctuation characteristic.

[0088] Step S260: If the current maximum speed value is greater than the gear speed value and less than the historical average maximum value, it is determined that premature beats have occurred.

[0089] In a preferred embodiment, when it is determined that R1>R0, and R1<R H , then this speed feature can be used as an auxiliary verification basis for premature beats. Among them, R1>R0 indicates that the heart has indeed contracted at this time, and R1<R H This indicates that there is less blood when the heart contracts.

[0090] In a preferred embodiment, step S240 further includes step S241 of determining a speed threshold based on the gear speed and the historical average maximum speed. Step S260 further includes step S261 of determining a premature beat if the current maximum speed is greater than the gear speed but less than the speed threshold.

[0091] Preferably, the speed judgment threshold is set to the gear speed R0 and the historical average maximum value R H The middle value of the speed judgment threshold is (1 / 2)×(R H +R0), at this time, if R1 satisfies R0 <R1<(1 / 2)×(R H +R0), it can be determined that premature beats have occurred.

[0092] In a preferred embodiment, step S240 further includes step S242 of determining the first maximum speed value after the current maximum speed value. Step S260 further includes step S262 of determining the occurrence of premature beats when the first maximum speed value is greater than the historical average maximum value. In this case, the first maximum speed value after the current maximum speed value R1 is defined as R2.

[0093] Specifically, after the premature beat occurs, the ventricle fails to complete a complete blood filling period, resulting in a decrease in the amount of blood discharged, making the current maximum speed R1 < R H However, due to the fact that part of the blood is pumped out, less blood accumulates in the ventricles during premature beats. In the subsequent cardiac contraction, since the blood was not completely discharged in the previous contraction, more blood accumulates in the ventricles in the next contraction. Therefore, the amount of blood discharged increases, resulting in a higher blood volume than usual. As a result, the first maximum speed value R2 that follows is greater than the average maximum value R H , that is, R2>R H .

[0094] In a preferred embodiment, the method further includes step S280, generating an alarm prompt and a control instruction to lower the gear of the ventricular assist device based on the premature beat determination result.

[0095] Specifically, the gear of the VAD refers to the speed or power level of the catheter pump. When a premature beat is detected, the VAD is temporarily downgraded to one or more gears, reducing the pump speed or output power to accommodate the abnormal hemodynamic state of the heart during the premature beat, mitigate clinical risks, and ensure the VAD is optimally adapted to the patient's heart condition.

[0096] Specifically, the alarm prompts include but are not limited to sound alarms, visual prompts, tactile feedback or remote notifications. The severity of the alarm prompts can be dynamically adjusted according to the frequency and duration of premature beats, so that medical staff can understand the patient's heart rate status in a timely manner.

[0097] refer to Figure 8 、 Figure 9 In a preferred embodiment, the catheter pump is also integrated with a pressure sensor for real-time acquisition of intravascular pressure change data. Preferably, it also includes:

[0098] Step S210: self-diagnose the working state of the pressure sensor. By monitoring the working state of the pressure sensor in real time, it is ensured that the pressure sensor data can be normally collected only when the pressure sensor is working normally, and premature beats are determined based on the pressure sensor data.

[0099] Step S230: collecting pressure sensor data in the ventricular assist device.

[0100] Step S250: Determine the real-time heart rate and heart rate reference value, as well as the pressure extreme value and pressure reference value based on the pressure sensor data.

[0101] Step S270: When the real-time heart rate is less than the heart rate reference value and the pressure extreme value deviates from the pressure reference value by more than a preset threshold, it is determined that a premature beat occurs.

[0102] It should be noted that step S230 can be performed simultaneously with step S220 or they can be performed sequentially; step S250 can be performed simultaneously with step S240 or they can be performed sequentially; step S270 can be performed simultaneously with step S260 or they can be performed sequentially.

[0103] In a preferred embodiment, in step S230, pressure sensor data is collected at a second preset sampling interval, where the second preset sampling interval is no longer than the duration of a cardiac cycle. Preferably, the second preset sampling interval has the same selectable interval as the first preset sampling interval, both being 10-100 ms. To achieve a balance between system resources and data accuracy, while also ensuring time synchronization with the speed data acquired in step S220, the second preset sampling interval is preferably set to 20 ms.

[0104] In a preferred embodiment, after the pressure sensor data is collected, it is necessary to perform necessary filtering processing on the collected pressure sensor data to eliminate noise interference.

[0105] In a preferred embodiment, in step S250, adjacent extreme points are first identified based on the pressure sensor data; the time interval between adjacent extreme points is determined; the real-time heart rate is determined based on the time interval; and the heart rate reference value is determined based on the historical heart rate data. Optionally, the adjacent extreme points are adjacent pressure maximum points or adjacent pressure minimum points.

[0106] Specifically, priority is given to identifying the pressure minimum point, that is, the lowest point of diastolic blood pressure. The time interval between two adjacent minimum points corresponds to a complete cardiac cycle. If the time interval between the two minimum points is t (unit: seconds), the real-time heart rate a (unit: times / minute) can be calculated by the formula a=60 / t. By analyzing multiple consecutive cardiac cycles, a set of heart rate data A can be obtained, in which each element represents the real-time heart rate data at a specific moment. By statistically analyzing the numerical distribution in the heart rate data set A, the heart rate value with the highest frequency of occurrence is identified as the reference heart rate a0. The reference heart rate a0 reflects the patient's dominant heart rhythm state over a period of time and can be used as a benchmark value for judging abnormal changes in heart rate.

[0107] Preferably, the pressure sensor data is dynamically monitored to continuously record the extreme point data in the pressure waveform. Preferably, the aforementioned pressure reference value includes a systolic pressure reference value and a diastolic pressure reference value. In step S230, the steps of determining the systolic pressure reference value based on the average of multiple historical maximum pressure values ​​and determining the diastolic pressure reference value based on the average of multiple historical minimum pressure values ​​are also included.

[0108] Preferably, the pressure data is processed by configuring a sliding window, and the length of the sliding window is preferably set to include data from the past 20 cardiac cycles. For the diastolic pressure reference value, the average value of the past 20 minimum pressure values ​​is calculated and defined as P L0 This value is used as the diastolic pressure reference value for judging abnormal diastolic pressure; for the systolic pressure reference value, the average value of the past 20 maximum pressure values ​​is calculated and defined as P H0 This value is used as the systolic blood pressure reference value for judging abnormal systolic blood pressure.

[0109] Preferably, step S250 further includes the step of determining a preset threshold, wherein the preset threshold includes a first preset threshold and a second preset threshold, the first preset threshold being determined based on a diastolic pressure reference value, and the second preset threshold being determined based on a systolic pressure reference value.

[0110] When determining the first preset threshold, the diastolic pressure reference value P L0 Subtract a preset offset, preferably 5 mmHg, that is, the first preset threshold is set to P L0 -5 (mmHg). Specifically, the setting of this offset is based on clinical observations, namely that within the normal heartbeat fluctuation range, the instantaneous change in diastolic blood pressure usually does not fall below the reference value by more than 5 mmHg; however, when premature beats occur, due to the shortened ventricular diastole and insufficient filling, diastolic blood pressure often decreases significantly.

[0111] When determining the second preset threshold, the systolic blood pressure reference value P H0 Add a preset offset, preferably 5 mmHg, that is, the second preset threshold is set to P H0 +5 (mmHg). Specifically, the offset setting is also based on clinical data analysis. In a compensatory heartbeat following a premature beat, the prolonged filling time of the previous heartbeat and increased ventricular filling volume generate a stronger contractile force, causing systolic blood pressure to be significantly higher than normal.

[0112] In a preferred embodiment, in step S270, when premature beats are determined based on the real-time heart rate and the extreme pressure value, the criteria for determining the real-time heart rate are: the real-time heart rate is lower than the heart rate reference value, and the real-time heart rate and the heart rate reference value satisfy a=ka0 (k is 0.4-0.6); or, the ratio of the real-time heart rate to the heart rate reference value satisfies 2×a=a0±10, that is, the real-time heart rate is approximately half of the reference heart rate. The criteria for determining the extreme pressure value are: when the minimum pressure value is detected to be lower than a first preset threshold value, and the first subsequent maximum pressure value is higher than a second preset threshold value, it is determined that the extreme pressure value deviates from the pressure reference value by more than the preset threshold value.

[0113] Preferably, if P L <P L0 -5, then the first pressure condition for premature beat judgment is met. Then track and analyze the first maximum pressure value P H , if P H >P H0 +5, the second pressure condition for premature beat determination is met. Only when the real-time heart rate feature and the two pressure features simultaneously meet the premature beat determination conditions can a premature beat be confirmed to have occurred, to avoid misjudgment.

[0114] One embodiment of the present application provides a computer-readable storage medium, wherein the storage medium stores at least one instruction, and the at least one instruction is loaded and executed by a processor to implement the premature beat detection method as described above.

[0115] An embodiment of the present application provides an electronic device, which includes a processor and a memory, wherein the memory stores at least one instruction, and the instruction is loaded and executed by the processor to implement the premature beat detection method as described above.

[0116] Those skilled in the art will understand that all or part of the steps to implement the above embodiments may be accomplished by hardware, or by a program to instruct the relevant hardware, and the program may be stored in a computer-readable storage medium, which may be a read-only memory, a disk, or an optical disk, etc.

[0117] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are protected by the present invention.

Claims

1. A device for detecting premature heart beats, characterized in that: include: a first sampling module configured to collect operating data of a drive motor in a ventricular assist device, wherein the operating data at least includes rotation speed data; a calculation module configured to determine a current maximum speed value and a historical average maximum speed value based on the speed data; The judgment module is configured to determine that premature beats occur when the current maximum speed value is greater than the gear speed and less than the historical average maximum value.

2. The premature heart beat detection device according to claim 1, wherein: The first sampling module is further configured to collect the rotation speed data at a preset sampling interval, where the preset sampling interval is no longer than the duration of one cardiac cycle.

3. The premature beat detection device according to claim 1, wherein: The calculation module is further configured to: determine a speed determination threshold value based on the gear speed and the historical average maximum value; The judgment module is further configured to: determine that premature beats occur when the current maximum speed value is greater than the gear speed and less than the speed judgment threshold.

4. The premature beat detection device according to claim 3, wherein: The speed determination threshold is half of the sum of the gear speed and the historical average maximum value.

5. The premature heart beat detection device according to claim 1, wherein: The calculation module is further configured to: determine the first maximum speed value after the current maximum speed value; The judgment module is further configured to determine that a premature beat occurs when the first maximum speed value is greater than a historical average maximum speed value.

6. The premature heart beat detection device according to claim 1, wherein: Also included is a second sampling module configured to collect pressure sensor data in the ventricular assist device; The judgment module is further configured to determine whether a premature beat occurs based on the pressure sensor data, and comprehensively determine the state of premature beat occurrence based on the premature beat determination result based on the speed data.

7. The premature beat detection device according to claim 6, wherein: The calculation module is further configured to: determine the real-time heart rate and heart rate reference value, as well as the pressure extreme value and pressure reference value based on the pressure sensor data; The judgment module is further configured to: when the real-time heart rate is less than the heart rate reference value, and the pressure extreme value deviates from the pressure reference value by more than a preset threshold, combine the judgment result of the speed data to determine that a premature beat has occurred.

8. The premature heart beat detection device according to claim 7, characterized in that: The calculation module is further configured to: Based on the pressure sensor data, identifying adjacent extreme value points; Determining the time interval between adjacent extreme points; determining the real-time heart rate according to the time interval; The heart rate reference value is determined based on historical heart rate data.

9. The premature heart beat detection device according to claim 8, characterized in that: The judgment module is further configured to: determine that a premature beat occurs when the real-time heart rate is less than the heart rate reference value and the real-time heart rate and the heart rate reference value satisfy a=ka0; Wherein k is 0.4-0.6, a is the real-time heart rate, and a0 is the heart rate reference value.

10. The premature heart beat detection device according to claim 7, characterized in that: The pressure reference value includes a systolic pressure reference value and a diastolic pressure reference value; The calculation module is further configured to: determine the systolic pressure reference value based on an average value of multiple historical pressure maximum values; and determine the diastolic pressure reference value based on an average value of multiple historical pressure minimum values.

11. The premature heart beat detection device according to claim 10, characterized in that: The preset threshold includes a first preset threshold and a second preset threshold, the first preset threshold is determined based on the diastolic pressure reference value, and the second preset threshold is determined based on the systolic pressure reference value; The judgment module is further configured to: when it is detected that the minimum pressure value is lower than the first preset threshold and the first maximum pressure value thereafter is higher than the second preset threshold, determine that the deviation of the pressure extreme value from the pressure reference value exceeds the preset threshold.

12. The premature heart beat detection device according to any one of claims 1 to 11, characterized in that: Also includes: The control module is configured to generate a control instruction for lowering the gear of the ventricular assist device according to the premature beat determination result of the determination module.

13. The premature heart beat detection device according to any one of claims 1 to 11, characterized in that: Also includes: The alarm module is configured to generate an alarm prompt according to the premature beat determination result of the determination module.

14. A method for detecting premature heart beats, characterized in that: include: Collecting operating data of a drive motor in a ventricular assist device, wherein the operating data at least includes speed data; Determining the current maximum speed value, the historical average maximum speed value, and the gear speed based on the speed data; When the current maximum speed value is greater than the gear speed and less than the historical average maximum value, it is determined that premature beats have occurred.

15. A ventricular assist system, characterized in that: It comprises a driving motor and a premature heart beat detection device as claimed in any one of claims 1 to 13.

16. A computer-readable storage medium, characterized in that The storage medium stores at least one instruction, which is loaded and executed by the processor to implement the premature beat detection method according to claim 14.

17. An electronic device, characterized in that: The electronic device includes a processor and a memory, wherein the memory stores at least one instruction, and the instruction is loaded and executed by the processor to implement the premature heart beat detection method according to claim 14.

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