Training evaluation method and device for balloon blocking hemostasis, medium and product

Abstract

The invention provides a training evaluation method and device for balloon blocking hemostasis, a medium and a product, and relates to the technical field of intelligent teaching. And respectively acquiring static pressure data reflecting the mechanical characteristics of the blood vessel wall and dynamic pressure data reflecting the hemodynamic characteristics. On the basis, the system combines specific preset bleeding case data, and determines hemostasis pressure ranges and partial hemostasis pressure ranges corresponding to different areas of the aorta under specific operation conditions through calculation. When a user operates, the system can call the matched pressure range standard according to the current real-time blocking position and the target operation combination parameter, and compares the collected real-time blocking pressure with the matched pressure range standard. According to the scheme, the technical problem that an existing simulation training system is difficult to adapt to complex fluid mechanics changes of a simulated person in different physiological states is solved.

Description

Technical Field

[0001] This application relates to the field of intelligent teaching technology, specifically to a training and assessment method, equipment, medium, and product for balloon occlusion hemostasis. Background Technology

[0002] Balloon aortic occlusion is a crucial technique in trauma emergency care for controlling massive bleeding at vital organs and the trunk junction. Through femoral / carotid / brachial / radial artery puncture, a balloon catheter is inserted into the corresponding location in the aorta and inflated to block blood flow below the balloon level, thus maintaining blood perfusion to core organs such as the heart and brain. Given the high risk of this procedure, skills training using medical simulation systems has become a standard approach in clinical teaching. These systems aim to create simulated experimental environments that allow trainees to practice procedures such as femoral / carotid / brachial / radial artery puncture, arterial sheath insertion, balloon catheter insertion into the aorta, balloon inflation to occlude the aorta, balloon release and retrieval, arterial sheath removal, and hemostasis at the arterial puncture site, thereby improving their balloon aortic occlusion hemostasis skills.

[0003] Existing simulation training systems typically consist of a mannequin, a fluid drive device, and a monitoring unit. Technically, the system uses the drive device to simulate blood circulation and presets fixed pressure or flow rates as assessment criteria. During training, the system monitors the tubing parameters after the balloon is inflated, directly comparing the collected real-time values ​​with preset fixed thresholds. When the monitored values ​​meet the preset criteria, the system determines that the hemostasis operation is complete and outputs feedback results accordingly.

[0004] However, blood vessels in real physiological environments possess complex hydrodynamic properties, and vascular compliance varies under different physiological states, making the pressure conditions required for safe hemostasis dynamically change. Existing technologies employ fixed thresholds or single-index judgment logic, simplifying the interaction mechanism between the balloon and the vessel wall, making it difficult to accurately distinguish between the pressure effect generated by fluid occlusion and the mechanical pressure exerted by the balloon on the vessel wall. This approach, when faced with complex training scenarios, fails to sensitively reflect the nonlinear relationship between operational force and changes in physiological parameters, resulting in insufficient accuracy in assessing the safety and effectiveness of the procedure in training evaluation results. Summary of the Invention

[0005] This application provides a training and evaluation method, device, medium, and product for balloon occlusion of aortic hemostasis, in order to solve the technical problem that existing simulation training systems are unable to adapt to the complex fluid dynamic changes of simulated humans under different physiological states, resulting in the inability to accurately evaluate the effectiveness and safety of hemostasis operations.

[0006] In a first aspect, this application provides a training and assessment method for balloon occlusion hemostasis, including: Based on the static and dynamic pressure data of the aorta of the simulated human, the hemostasis pressure range and partial hemostasis pressure range corresponding to different regions of the aorta under different operating combination parameters are calculated. The static pressure data is used to represent the vascular pressure of different regions of the aorta under different volumes of saline-filled balloons when the simulated human heart pumping mechanism is closed. The dynamic pressure data is used to represent the vascular pressure of different regions of the aorta under different volumes of saline-filled balloons under different operating combination parameters when the simulated human heart pumping mechanism is open. Based on preset bleeding case data, the simulator is controlled to run with a target running combination parameter to determine the bleeding status of the simulator. The target running combination parameter is any one of the plurality of different running combination parameters. Real-time data on hemostasis operations performed by the user on the aorta of the simulated human, including real-time occlusion location and real-time occlusion pressure; The target hemostasis pressure range and the target partial hemostasis pressure range are determined based on the target operating combination parameters and the real-time blocking position. The occlusion operation determination result is determined based on the target hemostasis pressure range, the target partial hemostasis pressure range, and the real-time occlusion pressure. The occlusion operation determination result includes: effective occlusion, partial occlusion, ineffective occlusion, and damaging occlusion.

[0007] Optionally, the step of calculating the hemostasis pressure range and partial hemostasis pressure range corresponding to different regions of the aorta under different operating parameter combinations based on the static and dynamic pressure data of the simulated human aorta further includes: When the heart pumping simulation mechanism is turned off, the baseline static pressure data corresponding to the target area of ​​the aorta of the simulated human is collected, and the target area is any one of a plurality of preset areas; After placing the simulated balloon into the target area, several different preset volume values ​​of physiological saline were determined; The target volume value of physiological saline is injected into the simulated balloon multiple times, and corresponding sampling static pressure data are collected for each injection. The target volume value is any one of the multiple different preset volume values. The average static pressure data corresponding to the target volume value is obtained by averaging multiple sampled static pressure data. The difference between the average static pressure data and the basic static pressure data corresponding to the target area is calculated to obtain the target static pressure data corresponding to the target area under the target volume value.

[0008] Optionally, the step of calculating the hemostasis pressure range and partial hemostasis pressure range corresponding to different regions of the aorta under different operating parameter combinations based on the static and dynamic pressure data of the simulated human aorta further includes: When the heart pumping simulation mechanism is activated, multiple different combinations of operating parameters for the simulated human are determined; When the simulated human is in the target operating combination parameters, the basic dynamic pressure data corresponding to the target region of the aorta of the simulated human is collected, and the target region is any one of a plurality of preset regions; After the simulated balloon is placed into the target area of ​​the aorta of the simulated human, multiple different preset volume values ​​of saline are determined; The target volume of physiological saline was injected into the simulated balloon multiple times, and corresponding dynamic pressure data were collected for each injection. The target volume was any one of the multiple different preset volume values. The average dynamic pressure data corresponding to the target volume value is obtained by averaging multiple sampled dynamic pressure data. Based on the difference between the average dynamic pressure data and the basic dynamic pressure data corresponding to the target area, the target dynamic pressure data corresponding to the target area when the simulated person is in the target operating combination parameters and the target volume value is obtained.

[0009] Optionally, determining the target hemostasis pressure range and the target partial hemostasis pressure range based on the target operating combination parameters and the real-time blocking position specifically includes: For the target area, a static pressure curve of the target area is plotted based on the target static pressure data, and an extreme pressure point where the slope of the static pressure curve exceeds a preset safety threshold is selected, and the pressure value of the extreme pressure point is determined as the highest safe pressure value. The target hemostasis pressure range is determined by taking the highest safe pressure value as the upper limit of the range and the minimum effective hemostasis pressure value pre-marked in the target dynamic pressure data as the lower limit of the range. The minimum effective hemostatic pressure value is used as the upper limit of the range, and the pre-marked initial blocking pressure value in the target dynamic pressure data is used as the lower limit of the range to determine the target partial hemostatic pressure range.

[0010] Optionally, determining the occlusion operation judgment result based on the target hemostasis pressure range, the target partial hemostasis pressure range, and the real-time occlusion pressure specifically includes: When the real-time blocking pressure is less than the lower limit of the target part hemostasis pressure range, the blocking operation determination result is determined to be invalid blocking; When the real-time blocking pressure is greater than or equal to the lower limit of the target partial hemostasis pressure range and less than the upper limit of the target partial hemostasis pressure range, the blocking operation determination result is determined as partial blocking; When the real-time blocking pressure is greater than or equal to the upper limit of the target hemostasis pressure range and less than or equal to the upper limit of the target hemostasis pressure range, the blocking operation determination result is determined as the effective blocking; When the real-time blocking pressure is greater than the upper limit of the target hemostasis pressure range, the blocking operation determination result is determined as the invasive blocking.

[0011] Optionally, after real-time acquisition of hemostasis operation data of the user on the aorta of the simulated human, the hemostasis operation data also includes blood loss and operation time, and the method further includes: Based on a preset blood loss grading standard, the blood loss is mapped to a blood loss control score; Based on a preset operation duration threshold, an operation efficiency score corresponding to the operation duration is determined; The blood loss control score and the operational efficiency score are weighted and calculated according to preset weighting coefficients to obtain the operational score.

[0012] Optionally, the method further includes: A flexible pressure sensor array is disposed on the inner and outer walls of the simulated human blood vessel; The flexible pressure sensor array collects the pressure type data corresponding to the user's hemostasis operation.

[0013] In a second aspect, embodiments of this application provide a training and evaluation device for balloon occlusion hemostasis, the training and evaluation device for balloon occlusion hemostasis comprising: one or more processors and a memory; the memory is coupled to the one or more processors, the memory being used to store computer program code, the computer program code including computer instructions, the one or more processors calling the computer instructions to cause the training and evaluation device for balloon occlusion hemostasis to perform the method as described in the first aspect and any possible implementation thereof.

[0014] Thirdly, embodiments of this application provide a computer program product containing instructions that, when the computer program product is run on a training and evaluation device for balloon occlusion hemostasis, cause the training and evaluation device for balloon occlusion hemostasis to perform the method described in the first aspect and any possible implementation thereof.

[0015] Fourthly, embodiments of this application provide a computer-readable storage medium including instructions that, when executed on a training and evaluation device for balloon occlusion hemostasis, cause the training and evaluation device for balloon occlusion hemostasis to perform the method described in the first aspect and any possible implementation thereof.

[0016] In summary, one or more technical solutions provided in the embodiments of this application have at least the following technical effects or advantages: 1. By adopting the above technical solution, the system first acquires static pressure data reflecting the mechanical properties of the blood vessel wall and dynamic pressure data reflecting the hemodynamic properties, based on data from the simulated human heart pumping mechanism in both closed and open states. On this basis, the system, combined with specific preset bleeding case data, calculates and determines the hemostatic pressure range and partial hemostatic pressure range corresponding to different regions of the aorta under specific operating conditions. During user operation, the system can call up the matching pressure range standard based on the current real-time occlusion position and target operating parameters, and compare the collected real-time occlusion pressure with it. This processing method deconstructs complex physiological feedback into quantifiable multi-range indicators, enabling the system to distinguish between four states: normal pressure - effective occlusion, low pressure - partial occlusion, low pressure - ineffective occlusion, and high pressure - damaging occlusion, achieving a refined assessment of the safety and effectiveness of interventional hemostasis operations.

[0017] 2. By adopting the above technical solution, under conditions where the cardiac pumping simulation mechanism is closed and there is no fluid impact interference, the system collects baseline static pressure data for the target area and performs multiple filling tests using physiological saline with different preset volumes. By averaging the collected static pressure data and subtracting the influence of baseline static pressure data, the system can obtain target static pressure data after eliminating background noise. This process isolates fluid dynamic factors and calibrates solely for the mechanical pressure generated on the vessel wall by the simulated balloon expansion. The obtained target static pressure data accurately reflects the compliance characteristics of the simulated vessel wall under different filling volume conditions, providing pure and accurate physical reference data to support subsequent determination of whether operations will cause mechanical damage to the vessel wall.

[0018] 3. By adopting the above technical solution, the system simulates different physiological operating conditions and collects corresponding baseline dynamic pressure data when the cardiac pumping simulation mechanism is activated. By injecting different preset volumes of saline solution into the simulated balloon, the system records the resulting sampled dynamic pressure data. After averaging and calculating the difference with baseline data, the target dynamic pressure data is obtained. This process simulates the pressure accumulation effect of real blood flow obstruction and establishes a mapping relationship between balloon inflation volume, operating parameters, and changes in intravascular fluid pressure. This allows the system to quantify the hydrodynamic conditions required to achieve different degrees of blockage under specific cardiac pulsation and blood flow conditions, providing dynamic data consistent with physiological laws for determining the lower limit of hemostasis effectiveness.

[0019] 4. By adopting the above technical solution, the system constructs a pressure change curve using target static pressure data and identifies the inflection point where the vessel wall compliance decreases sharply by analyzing the rate of change of the curve's slope, thereby determining the highest safe pressure value characterizing the vessel wall's tolerance limit. Subsequently, the system logically combines this highest safe pressure value with the minimum effective hemostatic pressure value and the initial occlusion pressure value derived from target dynamic pressure data to construct a target hemostatic pressure range and a target partial hemostatic pressure range with clearly defined upper and lower limits. This judgment logic effectively combines the mechanical tolerance limit of the vessel wall with the effectiveness requirement of blood flow occlusion, strictly limiting the safe boundary of the operating pressure while ensuring hemostasis, thus enabling an objective evaluation of whether the trainee has completed an effective hemostatic operation without causing mechanical damage to the vessel. Attached Figure Description

[0020] Figure 1 This is a flowchart illustrating a training and evaluation method for balloon occlusion hemostasis in an embodiment of this application; Figure 2 This is a schematic diagram of the circuit structure in an embodiment of this application; Figure 3 This is a schematic diagram of the physical device structure of a training and evaluation device for balloon occlusion hemostasis in the embodiments of this application. Detailed Implementation

[0021] To enable those skilled in the art to better understand the technical solutions in this specification, the technical solutions in the embodiments of this specification will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments.

[0022] In the description of the embodiments of this application, the words "for example" or "for instance" are used to indicate examples, illustrations, or explanations. Any embodiment or design that is described as "for example" or "for instance" in the embodiments of this application should not be construed as being more preferred or advantageous than other embodiments or design options. Rather, the use of the words "for example" or "for instance" is intended to present the relevant concepts in a specific manner.

[0023] In the description of the embodiments of this application, the term "multiple" means two or more. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the indicated technical features. Thus, a feature defined with "first," "second," or "third" may explicitly or implicitly include one or more of that feature. The terms "comprising," "including," "having," and variations thereof all mean "including but not limited to," unless otherwise specifically emphasized. It should be noted that all data collection in this scheme is conducted after obtaining user consent.

[0024] This application provides a training and assessment method for balloon occlusion hemostasis, referring to... Figure 1 , Figure 1 This is a flowchart of a training and evaluation method for balloon occlusion hemostasis provided in an embodiment of this application. The method includes: Step S101: Calculate the hemostasis pressure range and partial hemostasis pressure range of different regions of the aorta under different operating parameter combinations based on the static and dynamic pressure data of the simulated human aorta. In this scheme, the different regions mainly target three regions: Aortic Region I (between the left subclavian artery and the celiac trunk), Aortic Region II (between the celiac trunk and the renal artery), and Aortic Region III (between the renal artery and the aortic bifurcation). Static pressure data refers to the mechanical resistance pressure of the blood vessel wall measured when different gradient volumes of physiological saline are injected into the hemostatic balloon in the three regions with different diameters and compliance, when the simulated human heart pumping mechanism is closed and the fluid is in a static state. For example, injecting 20 ml of physiological saline into the larger diameter Aortic Region I produces a pressure of 180 mmHg, while injecting the same volume into the smaller diameter Aortic Region III produces a pressure of 240 mmHg. Dynamic pressure data refers to the superimposed pressure, including fluid impact force, measured when different volumes of saline are injected into the hemostatic balloon in zones I, II, and III of the aorta under different combinations of heart rate and stroke volume (operational combination parameters) when the cardiac pumping simulation mechanism is activated and outputting pulsatile flow. For example, in a shock simulation state with a heart rate of 120 beats / min and a stroke volume of 30 ml, the pressure generated by injecting 15 ml into zone I of the aorta is 140 mmHg, while in a normal state with a heart rate of 70 beats / min and a stroke volume of 70 ml, the pressure generated by injecting the same volume into the same zone is 160 mmHg. The operation combination parameters mainly include heart rate and stroke volume, which are used to define the working state of the cardiac pumping simulation mechanism, such as the combination of "high heart rate and low stroke volume" or "low heart rate and high stroke volume". The hemostatic pressure range is used to indicate the pressure range that can effectively counteract the hydrodynamic pressure generated by the current heart rate and stroke volume without exceeding the static tolerance limit of the vessel wall in that area. For example, for the aortic zone III, it may be 150 to 190 mmHg at a heart rate of 70 beats / min and a stroke volume of 70 ml. The partial hemostatic pressure range is used to indicate the transitional pressure range that can only partially block blood flow. For example, for the aortic zone III, it may be 100 to 149 mmHg at a heart rate of 70 beats / min and a stroke volume of 70 ml.

[0025] Specifically, this step is executed as part of the system's initial data construction phase. The calculation unit first reads static pressure data, establishes physical characteristic models of the vessel walls in aortic zones I, II, and III, and determines the maximum safe pressure threshold for each zone. Subsequently, the system combines dynamic pressure data to analyze the required intraballoon pressure to overcome blood flow impact and achieve aortic occlusion under different combinations of heart rate (e.g., 60 to 150 beats / min) and stroke volume (e.g., 20 to 100 ml). Through multidimensional data fusion, the system constructs a large lookup table or database that records in detail the complete hemostasis pressure window (hemostasis pressure range) and partial hemostasis pressure window (partial hemostasis pressure range) for each aortic zone I, II, and III under each combination of heart rate and stroke volume.

[0026] Step S102: Based on preset bleeding case data, control the simulator to run with target running parameters to determine the bleeding status of the simulator; Among them, the preset bleeding case data refers to the parameter configuration files stored in the system that correspond to specific clinical emergency situations, such as "splenic artery rupture bleeding", "abdominal aortic rupture bleeding", "traumatic abdominal bleeding", "pelvic bleeding", "car accident causing pelvic fracture with massive bleeding in aortic zone III" or "fall from a height causing chest trauma with aortic zone I injury", etc.; the target operating combination parameters refer to the specific execution instructions issued by the controller to the cardiac pumping simulation mechanism (model DC40-2470 water pump) in order to reproduce the above cases, mainly reflected in specific target heart rate values ​​and target stroke volume values, such as setting the heart rate to 130 beats / min and the stroke volume to 35 ml to simulate hemorrhagic shock; the bleeding status represents the macroscopic physical characteristics of the fluid circuit after the simulated person executes the above parameters, such as a decrease in mean arterial pressure, a rapid and weak pulse, and a continuous decrease in simulated circulating blood volume.

[0027] Specifically, this step is performed at the beginning of training. The main control module analyzes the preset bleeding case data selected by the teaching end and converts it into low-level control signals for the fluid drive system. The system drives the simulated heart pump to reciprocate at the target heart rate frequency and adjusts the piston stroke to achieve the target stroke volume, while simultaneously opening the leakage valve in the corresponding area (such as aortic zone III). By precisely controlling these two core variables, the fluid dynamics environment inside the simulated human is forced to change from a resting state to a specific pathological state, providing trainees with a realistic operating environment with specific flow rate, volume, and pressure characteristics.

[0028] Step S103: Real-time data collection of hemostasis operation on the aorta of the simulated human, including real-time occlusion location and real-time occlusion pressure; Among them, hemostasis operation data represents the set of physical quantities generated when the user interacts with the mannequin using the interventional balloon catheter; real-time occlusion position refers to the specific anatomical region of the simulated blood vessel where the tip of the balloon catheter is currently located, clearly distinguishing whether it is located in aortic zone I, aortic zone II, or aortic zone III. For example, the position sensor return signal indicates that the balloon is located in "aortic zone III" below the renal artery; real-time occlusion pressure refers to the pressure exerted on the blood vessel wall during balloon inflation. For example, the data stream shows that the pressure is rising from 50 mmHg to 250 mmHg.

[0029] Specifically, this step is integrated throughout the user's entire operation. The system utilizes an electromagnetic tracking system or segmented radio frequency identification sensors arranged along the simulated blood vessel path to scan the balloon position at millisecond-level frequencies, determining in real time whether the balloon is currently positioned in aortic zone I, II, or III. Simultaneously, a pressure transmitter connected to the end of the balloon catheter continuously collects pressure change data within the balloon. The acquisition unit synchronously converts the position coordinate information and simulated pressure and voltage signals into digital signals, adds a time stamp, and transmits them to the central processing unit for subsequent logical operations.

[0030] Step S104: Determine the target hemostasis pressure range and the target partial hemostasis pressure range based on the target operating combination parameters and the real-time blocking position; The target hemostatic pressure range refers to the pressure standard range that is defined as "effective and safe" by the system based on the specific anatomical location (aortic zone I, II, or III) at the current moment and the current operating status of the cardiac pumping simulation mechanism (specific heart rate and stroke volume). For example, when the balloon is located in aortic zone I and the heart rate is 100 beats / min, the corresponding effective range is 100 to 180 mmHg. The target partial hemostatic pressure range refers to the pressure standard range that is defined as "resisted but not complete" under the same conditions, such as 80 to 110 mmHg.

[0031] Specifically, this step is executed within the data processing logic. The processor extracts the real-time occlusion location identified in step S103 (e.g., "Aortic Zone II") and the target operating parameters set in step S102 (e.g., "heart rate 110, stroke volume 40"). Using these two sets of data as index keys, the processor searches the database generated in step S101 to quickly locate the pressure threshold applicable to the current specific anatomical location and hemodynamic state. This mechanism ensures that the evaluation criteria are dynamically updated: if operating in Aortic Zone I, the system will use the high-pressure criteria for Zone I; if moving to Aortic Zone III, the system will automatically switch to the appropriate criteria for Zone III.

[0032] Step S105: Determine the blocking operation judgment result based on the target hemostasis pressure range, the target partial hemostasis pressure range, and the real-time blocking pressure; The occlusion operation judgment result represents the system's final qualitative evaluation of the user's hemostasis effect, including four discrete states: normal pressure - effective occlusion (perfect operation), low pressure - partial occlusion (incomplete hemostasis), low pressure - ineffective occlusion (no effect), and high pressure - damaging occlusion (may cause blood vessel rupture).

[0033] Specifically, this step is where the evaluation conclusion is output. The system compares the real-time occlusion pressure value collected in real time with the target hemostasis pressure range and the target partial hemostasis pressure range dynamically retrieved in step S104. If the real-time pressure falls within the target hemostasis pressure range, it is determined to be normal pressure - effective occlusion; if it falls within the target partial hemostasis pressure range, it is determined to be slightly low pressure - partial occlusion; if it is below the lower limit of the partial hemostasis pressure range, it is determined to be too low pressure - ineffective occlusion; if it is above the upper limit of the target hemostasis pressure range (i.e., exceeding the safety limit determined based on static data for this area), it is determined to be too high pressure - damaging occlusion. This result is then used to generate a training report or trigger an alarm feedback.

[0034] Specifically, when the real-time blocking pressure is greater than or equal to the lower limit of the target part hemostasis pressure range and less than the upper limit of the target part hemostasis pressure range, the blocking operation judgment result is determined as slightly lower pressure - partial blocking. When the real-time blocking pressure is greater than or equal to the upper limit of the target hemostasis pressure range and less than or equal to the upper limit of the target hemostasis pressure range, the blocking operation result is determined as normal pressure - effective blocking. When the real-time occlusion pressure exceeds the upper limit of the target hemostasis pressure range, the occlusion operation result is determined as excessive pressure - damaging occlusion.

[0035] The following is a more detailed description of the process of the method provided in this implementation.

[0036] Optionally, this solution collects various stress data during the simulated human operation process using the following methods; Step S106: A flexible pressure sensor array is disposed on the inner and outer walls of the simulated human blood vessel; Among them, the inner and outer walls of the simulated human blood vessel refer to the inner and outer surfaces of the silicone or biomimetic material tubes used in the simulated human model to reproduce the aorta and its branch structures. These surfaces are in direct contact with the simulated blood and bear the physical contact force from the balloon catheter. The flexible pressure sensor array refers to a mesh or strip-shaped electronic device composed of multiple miniaturized, flexible and deformable pressure-sensitive elements, such as a polyimide film sensor matrix based on piezoresistive or capacitive principles, which has high spatial resolution and good curved surface fitting ability. Setting refers to fixing or embedding the sensor array into the inner layer of the blood vessel tube through micro-encapsulation technology, adhesive bonding or integral casting, so that it covers the inner circumferential surface of the critical operating areas such as zone I, zone II, and zone III of the aorta.

[0037] Specifically, this step is a key process in the hardware manufacturing and assembly stage of the simulation system. The manufacturing system first designs a sensor wiring diagram that matches the inner diameter of the blood vessel based on the anatomical data of the real human aorta. A flexible substrate material with biocompatibility and a mechanical modulus similar to that of the simulated blood vessel material is selected, and high-density pressure-sensing pixels (e.g., four sensing points per square centimeter) are fabricated on it using photolithography or printing processes. Subsequently, during or after blood vessel formation, this flexible pressure sensor array is seamlessly attached to the inner wall of the blood vessel, ensuring that the sensor array can deform synchronously with the pulsation of the blood vessel wall without altering the original hydrodynamic properties of the blood vessel or obstructing the passage of interventional devices. This layout ensures full-coverage monitoring of the force at any location inside the blood vessel, eliminating blind spots that may exist in traditional single-point measurements.

[0038] Step S107: Collect pressure type data corresponding to the user's hemostasis operation through the flexible pressure sensor array; In the circuit principle, each sensing unit of the flexible pressure sensor array is equivalent to a variable resistor (RS) whose resistance changes with external pressure. For example, when the balloon compresses the blood vessel wall, the resistance value of the sensing unit at the pressure point shifts significantly. The user's hemostasis operation refers to the physical process in which the operator controls the balloon to inflate at a specific location within the blood vessel, thereby applying mechanical pressure to the blood vessel wall and the sensor array. Data acquisition refers to the process by which the electronic measurement system reads the analog voltage signals of the circuit nodes connected in series with each sensing unit. Pressure type data refers to the set of physical quantities calculated backward from the voltage signals, mainly including balloon position data determined by the resistance change location, and pressure distribution data determined by the resistance change amplitude.

[0039] For details, please refer to Figure 2This step is performed based on the principle of a series voltage divider circuit. The system provides a constant power supply voltage (Vcc) to the flexible pressure sensor array and connects each sensing unit in the array, which acts as a variable resistor (RS), in series with a fixed resistor (R) of known resistance. In the initial state where the user is not operating, the sensor resistance RS is relatively stable, and the output voltage (Vout) across the fixed resistor remains at a reference value. When the user performs hemostasis, causing the balloon to inflate and compress the inner wall of the blood vessel, the sensor unit in the stressed area deforms, resulting in a change in the physical resistance RS of the sensor unit. Since both the power supply voltage Vcc and the fixed resistor R are known and constant, according to the voltage divider formula Vout = Vcc * R / (R + RS), the change in the sensor resistance RS directly causes a nonlinear change in the output voltage Vout. The data acquisition unit monitors the output voltage Vout across the fixed resistor in real time, and the processor uses the above formula to calculate the current sensor resistance RS based on the change in this voltage value. The system determines the balloon position based on the physical coordinates of the sensing units in the array that experience resistance changes within the blood vessel; simultaneously, it maps the corresponding pressure intensity based on the magnitude of the resistance RS change, thereby generating pressure type data containing both position and pressure intensity information.

[0040] Optionally, steps S10801-S10805 constitute the method for obtaining static pressure data in this scheme.

[0041] Step S10801: When the heart pumping simulation mechanism is turned off, collect the baseline static pressure data corresponding to the target area of ​​the aorta of the simulated human, wherein the target area is any one of multiple preset areas; The target area refers to the specific blood vessel location selected for pressure data acquisition in the current measurement step; multiple preset areas refer to the set of all measurable blood vessel segments predefined by the system based on anatomical features, such as aortic zones I, II, and III; the baseline static pressure data represents the hydrostatic pressure of the fluid within the target area when the fluid power source is stopped and there is no interventional device dilation, such as the baseline pressure of 5 mmHg or 8 mmHg measured when the pump is off and the tubing is full of fluid.

[0042] Specifically, this step is performed during the initialization phase of the static calibration process. Before the system begins the formal balloon pressure test, the controller first sends a shutdown command to the cardiac pumping simulation mechanism, causing the fluid in the simulated circulation loop to stop circulating and reach a state of static equilibrium. At this time, because the system tubing is still filled with simulated blood, and the fluid itself possesses gravitational potential energy, the blood vessel walls will experience a certain hydrostatic pressure. The data acquisition system selects a target area (such as aortic zone III) and reads the current pressure value through pressure sensors placed in that area. To ensure data accuracy, the system typically collects data continuously for a period of time (such as 3 seconds) and calculates the average, locking it as the baseline static pressure data for that area. This data will serve as the "zero point" or subtraction item for subsequent calculations, used to eliminate the interference of the fluid's own gravity on the balloon inflation pressure measurement.

[0043] Step S10802: After placing the simulated balloon into the target area, determine multiple different preset volume values ​​of physiological saline. Among them, the simulated balloon refers to an inflatable elastic balloon component located at the tip of the interventional catheter, such as a compliant balloon with a maximum volume of 40 ml; insertion refers to the operation of delivering the catheter and balloon to a specific location inside the vascular model by physical propulsion; multiple preset volume values ​​represent a series of incremental or specific injection volume nodes set in order to construct a pressure-volume relationship curve, such as a volume sequence of 2 ml, 5 ml, 10 ml, 15 ml, 20 ml and 30 ml.

[0044] Specifically, this step is performed during the parameter configuration phase after the basic data acquisition is completed. Once the operating device precisely positions the simulated balloon to the target area selected in step S10801, the control system calls upon the corresponding test protocol based on the vessel diameter characteristics of that target area (e.g., the diameter is larger in aortic zone I and smaller in aortic zone III). The system extracts a list of volume gradients suitable for that area from the database, determining multiple different preset volume values ​​required for this test. For example, for the smaller aortic zone III, the determined preset volume value sequence may be more dense and have a lower upper limit (e.g., 2ml to 20ml); while for the larger aortic zone I, the determined upper limit of the sequence may be higher (e.g., up to 30ml). This step ensures that the test covers the entire process from when the balloon does not contact the vessel wall to when blood flow is completely blocked.

[0045] Step S10803: Inject physiological saline of the target volume value into the simulated balloon multiple times, and collect corresponding sampling static pressure data for each injection. The target volume value is any one of the multiple different preset volume values. The target volume value refers to the specific injection volume set in the current single test cycle, such as the specific value of "10 ml" in the sequence; multiple injections refer to repeatedly performing the "fill-hold-drain" cycle for the same target volume value, such as repeating the operation 3 or 5 times for the 10 ml volume; sampled static pressure data represents the instantaneous total pressure value recorded by the sensor after each injection operation is completed and stabilized, such as 85 mmHg after the first injection of 10 ml and 86 mmHg after the second injection of the same volume.

[0046] Specifically, this step is performed in the core implementation phase of data acquisition. A high-precision infusion pump draws a precise dose of saline solution into the balloon according to instructions, bringing it to the target volume. Due to the viscoelastic properties of the balloon material and the vascular model material (such as silicone), stress relaxation occurs after the pressure momentarily inflates. Therefore, the system waits for a preset stabilization time (e.g., 2 seconds) after injection to allow the pressure reading to stabilize before triggering data acquisition and recording the current static pressure data. Subsequently, the system aspirates the fluid to empty the balloon. To eliminate random errors from a single operation and the hysteresis effect of the material, the system repeats the above process for the same target volume. For example, for a target volume of 15 ml, the system performs 5 injections, collecting 5 sets of static pressure data for each, providing samples for subsequent statistical processing.

[0047] Step S10804: Average the multiple sampled static pressure data to obtain the average static pressure data corresponding to the target volume value; The average static pressure data refers to the standard pressure response value obtained after calculation, which represents the target area under a specific filling volume.

[0048] Specifically, this step is performed during the data cleaning phase after the single-point test cycle. The calculation unit extracts all raw sampled static pressure data acquired in step S10803 for the same target volume value (e.g., 20 ml). The system first executes an outlier removal algorithm to filter out extreme data caused by air bubbles or mechanical vibration, and then sums the remaining valid data and divides it by the sample size. The calculated arithmetic mean is defined as the average static pressure data at that volume. This value characterizes the statistically expected total pressure exerted on the vessel wall when the balloon inflates to that volume after eliminating random measurement errors.

[0049] Step S10805: Calculate the difference between the average static pressure data and the basic static pressure data corresponding to the target area to obtain the target static pressure data corresponding to the target area under the target volume value; The target static pressure data refers to the mechanical pressure exerted on the blood vessel wall by the balloon inflation, after deducting the baseline static pressure.

[0050] Specifically, this step is the calculation stage for generating the final calibration data. The processor uses the baseline static pressure data of the region measured in step S10801 as the background noise value, and uses the average static pressure data calculated in step S10804 as the total measurement value including the background. Through subtraction (average static pressure data minus baseline static pressure data), the system removes the influence of hydrostatic pressure, thereby obtaining the vessel wall stress data caused only by balloon volume expansion. This target static pressure data and the corresponding target volume value are paired and stored. The system iterates through all preset volume values ​​and repeats the above steps to finally generate complete target static pressure data for the target region.

[0051] Optionally, steps S10901-S10906 constitute the method for obtaining dynamic pressure data in this scheme.

[0052] Step S10901: When the heart pumping simulation mechanism is turned on, determine multiple different operating combination parameters of the simulated human. Among them, the operating combination parameters refer to the core variable pair that directly controls the output characteristics of the heart pumping simulation mechanism. In this embodiment, it specifically refers to the specific numerical combination of the two parameters: heart rate (number of heartbeats per minute) and stroke volume (volume of blood pumped out in a single heartbeat), such as the combination of "heart rate of 75 beats / min and stroke volume of 70 ml". Multiple different operating combination parameters refer to the system's preset list of operating conditions covering a variety of physiological states, which is used to comprehensively test the performance of the balloon in pumping capacity under different heart pumping simulation mechanisms.

[0053] Specifically, this step is performed during the initiation phase of the dynamic calibration process. The system controller activates the cardiac pumping simulation mechanism, preparing it to deliver simulated blood into the tubing. To establish a pressure database applicable to different patient physiological characteristics, the system first plans the range of operating conditions to be tested. The processor reads a series of parameter configuration files from the pre-stored database, determining the various states that need to be executed sequentially in this experiment. For example, the system determines that the first set of parameters simulates a normal resting state (e.g., heart rate 70 beats / min, stroke volume 70ml), and the second set of parameters simulates a high-volume exercise state (e.g., heart rate 100 beats / min, stroke volume 90ml). This step ensures that the subsequently acquired pressure data can adapt to the complex intravascular fluid environment caused by changes in heart rate and pump volume.

[0054] Step S10902: When the simulated human is in the target operating combination parameters, collect the basic dynamic pressure data corresponding to the target region of the aorta of the simulated human. The target operating combination parameters are any one of the multiple different operating combination parameters, and the target region is any one of the multiple preset regions. Among them, the target running combination parameters refer to the specific set of heart rate and stroke volume settings that are being executed in the current test cycle, such as the current setting of "heart rate 60 beats / min, stroke volume 60ml"; the baseline dynamic pressure data represent the periodic vascular pressure data driven by a specific heart rate and stroke volume that the inner wall of the blood vessel is subjected to in the absence of balloon intervention and only in the state of simulated blood flow.

[0055] Specifically, this step aims to acquire the current "ambient background noise." Once the system controls the cardiac pumping simulation mechanism to operate stably according to the target operating parameters (i.e., the set heart rate and stroke volume), and before the balloon is inserted or inflated, the data acquisition system initiates monitoring of the selected target area. Because the cardiac pumping simulation mechanism pumps fluid at a fixed frequency and output, the pressure within the blood vessel exhibits regular fluctuations. The system records pressure changes over several complete cardiac cycles and extracts the characteristic values ​​under these conditions using signal processing algorithms, collectively referred to as baseline dynamic pressure data. This data reflects the impact pressure exerted by the fluid itself on the blood vessel wall under the current specific cardiac workload conditions.

[0056] Step S10903: After placing the simulated balloon into the target area of ​​the aorta of the simulated human, determine multiple different preset volume values ​​of physiological saline. Specifically, this step is the preparation and planning phase for dynamic testing. After measuring the background pressure, the operating device inserts the balloon catheter into the target area filled with flowing fluid. The system sets the test volume gradient based on the current anatomical dimensions of the vessel (e.g., vessel diameter) and the balloon specifications. Unlike static testing, the fluid impact determined by heart rate and stroke volume in dynamic testing may affect the balloon's morphology; therefore, the determined preset volume values ​​may require more fine grading to capture subtle pressure changes in the balloon under blood flow impact. The system generates a control list containing all test volume points, ready to execute the fluid injection operation sequentially.

[0057] Step S10904: Inject physiological saline of the target volume value into the simulated balloon multiple times, and collect corresponding sampling dynamic pressure data for each injection. The target volume value is any one of the multiple different preset volume values. Among them, the sampling dynamic pressure data represents the total pressure signal recorded by the sensor array when the balloon is inflated to the target volume and maintained in that state. This signal is a composite pressure value composed of the "compression force of the balloon wall on the blood vessel" and the "pulsating blood flow impact force generated by a specific heart rate and stroke volume".

[0058] Specifically, under conditions where the cardiac pumping simulation mechanism operates continuously at a set heart rate and stroke volume, the system controls the infusion pump to precisely inject a target volume of saline into the balloon. The balloon inflates and partially or completely blocks blood flow. At this time, the sensor located at the contact surface between the balloon and the blood vessel wall not only bears the static tension of the balloon expansion but also the transmitted pressure generated by the blood flow impacting the balloon. The system continuously collects pressure data for a period of time while the balloon remains inflated. To eliminate random errors caused by blood flow phase fluctuations (such as the injection timing falling precisely during the ejection or filling phase of the cardiac pumping simulation mechanism), the system performs multiple repeated tests, recording the dynamic pressure data after each inflation to ensure statistical representativeness of the sample.

[0059] Step S10905: Average the multiple sampled dynamic pressure data to obtain the average dynamic pressure data corresponding to the target volume value. The mean dynamic pressure data refers to the standard total pressure value obtained after processing, which represents the target area under a specific combination of heart rate and stroke volume, and a specific volume of saline injection. For example, 161 mmHg is obtained by averaging the average pressures of 160 mmHg, 165 mmHg, and 158 mmHg obtained from multiple measurements.

[0060] Specifically, pressure readings under dynamic conditions fluctuate dramatically due to the periodic movements of the cardiac pumping simulation mechanism (i.e., the frequency affected by heart rate and the amplitude affected by stroke volume), directly using a single measurement value would lead to significant errors. The processor extracts all sampled dynamic pressure data obtained in step S10904 and calculates a stable value using an algorithm. This average dynamic pressure data characterizes the stable pressure level detected by the sensor when the saline injection volume reaches the target volume value under the current specific operating parameters of the cardiac pumping simulation mechanism.

[0061] Step S10906: Based on the difference between the average dynamic pressure data and the basic dynamic pressure data corresponding to the target area, obtain the target dynamic pressure data corresponding to the target area when the simulated person is at the target volume value under the target operating combination parameters; Among them, the target dynamic pressure data refers to the net pressure value attributable to the physical expansion of the balloon after removing the background pressure of blood flow determined by heart rate and stroke volume in a dynamic environment with blood flow impact, that is, the effective contact stress of the balloon on the blood vessel wall; the target area under the target operating combination parameter conditions and the target volume value conditions refers to the specific multi-dimensional operating condition label (specific heart rate and stroke volume, specific injection volume, specific anatomical location) corresponding to the data.

[0062] Specifically, the system uses the average dynamic pressure data obtained in step S10905, which includes both blood flow and balloon effects, and subtracts the baseline dynamic pressure data measured in step S10902, which only includes blood flow effects (generated by the current heart rate and stroke volume). This calculation logic aims to eliminate the interference of fluid dynamic pressure on the measurement, thereby resolving the mechanical pressure characteristics of the balloon itself. For example, if the total pressure is 180 mmHg, and the average background fluid pressure generated by a specific heart rate and stroke volume at that time is 100 mmHg, then the calculated 80 mmHg is the target dynamic pressure data. Finally, the system associates and stores this data with the current heart rate, stroke volume, and volume value.

[0063] Optionally, steps S10401-S10403 are a more specific solution to step S104.

[0064] Step S10401: For the target area, draw a static pressure curve of the target area based on the target static pressure data, and select the extreme pressure point where the slope of the static pressure curve exceeds a preset safety threshold, and determine the pressure value of the extreme pressure point as the maximum safe pressure value. The target region refers to the specific vascular anatomical segment selected for data analysis in the current operation, such as aortic region I or aortic region III. The target static pressure data refers to the set of corresponding values ​​between balloon volume and vessel wall stress obtained in previous steps, after eliminating hydrostatic interference; for example, a set of data pairs containing a volume of 10 ml corresponding to a pressure of 80 mmHg and a volume of 20 ml corresponding to a pressure of 120 mmHg. The static pressure curve is used to represent a function graph or mathematical model of continuous pressure variation with volume, such as a non-linear growth curve plotted with volume as the x-axis and pressure as the y-axis. The slope refers to the static pressure curve... The inclination of the tangent at a specific point is mathematically represented by the first derivative of pressure with respect to volume (dP / dV), and physically represents the reciprocal of the stiffness or compliance of the blood vessel wall in its current state. The preset safety threshold is a critical value of stiffness defined by the system, representing the elastic limit of the blood vessel wall or the critical value of the impending physical damage. For example, a slope value of 3 mmHg / ml is set as a critical standard. The limit pressure point is the coordinate point on the static pressure curve when the slope value first reaches or exceeds the preset safety threshold. The maximum safe pressure value is the pressure value corresponding to the limit pressure point on the vertical axis. For example, 180 mmHg represents the upper limit of pressure to prevent blood vessel rupture.

[0065] Specifically, this step is performed during the data processing and analysis phase, aiming to establish the physical boundaries of safe operation. After acquiring discrete measurement data of the target area, the computing unit first uses mathematical algorithms such as interpolation or least squares to fit the discrete target static pressure data into a continuous static pressure curve. Subsequently, the system performs differential operations on the curve to calculate the slope at each point. Physiologically, as the balloon volume increases, the blood vessel wall is stretched. Initially, the blood vessel wall is elastic, and the pressure increase is gradual (small slope). When the blood vessel wall is stretched to near its limit, collagen fibers are stretched, the blood vessel wall hardens, and a small increase in volume leads to a sharp increase in pressure (sharply increased slope). The system iterates through the slope values ​​at each point on the curve. Once it detects that the slope of a certain point exceeds a preset safety threshold, it determines that the point is the inflection point of loss of vascular compliance, i.e., the limit pressure point. The system extracts the pressure value at this point and locks it as the highest safe pressure value to prevent aortic dissection or rupture due to overfilling.

[0066] Step S10402: Take the highest safe pressure value as the upper limit of the range and the minimum effective hemostasis pressure value pre-marked in the target dynamic pressure data as the lower limit of the range to determine the target hemostasis pressure range. Among them, the maximum safe pressure value refers to the safe pressure boundary that the blood vessel wall can withstand, as determined in step S10401; the upper limit of the range refers to the maximum numerical boundary that is allowed to be reached when the pressure range is set; the target dynamic pressure data refers to the comprehensive pressure-volume-flow rate dataset that includes hemodynamic information (such as the influence of heart rate and stroke volume); the minimum effective hemostatic pressure value refers to the minimum internal pressure value of the balloon required to completely block distal blood flow under dynamic blood flow impact, for example, under the condition of systolic blood pressure of 120 mmHg, when the distal flow rate drops to zero when the balloon pressure reaches 130 mmHg, then 130 mmHg is this value; the lower limit of the range refers to the minimum numerical boundary required when the pressure range is set; the target hemostatic pressure range is used to represent the optimal working pressure range that can achieve complete blockage of blood flow without causing vascular damage.

[0067] Specifically, this step is performed during the parameter planning phase of the complete blockade strategy. The system needs to define a "green zone" that can effectively stop bleeding without rupturing blood vessels. First, the system calls the maximum safe pressure value calculated in step S10401 and sets it directly as the top boundary of the zone.

[0068] Secondly, the system analyzes the target dynamic pressure data to find the critical point for complete blood flow occlusion. This typically requires combining flow rate sensor data or the characteristic of the distal pressure waveform disappearing to find the balloon pressure corresponding to the point where fluid flow just stops. This value is marked as the minimum effective hemostatic pressure and set as the bottom boundary of the range. The target hemostatic pressure range determined by these two boundaries provides clinicians or automated control systems with clear guidelines for complete occlusion: as long as the balloon pressure is maintained within this range, it ensures that the bleeding source is completely cut off without exceeding the physical tolerance limit of the vessel wall.

[0069] Step S10403: The minimum effective hemostatic pressure value is used as the upper limit of the range, and the pre-marked initial blocking pressure value in the target dynamic pressure data is used as the lower limit of the range, thus determining the target partial hemostatic pressure range. The minimum effective hemostatic pressure value refers to the critical pressure value that can achieve complete blood flow occlusion, which serves as the end point of the partial occlusion interval. The initial occlusion pressure value refers to the balloon pressure value at which the balloon wall begins to contact the blood vessel wall and generate initial resistance to blood flow during balloon inflation, resulting in an observable decrease in distal blood flow or pressure. For example, when the balloon pressure reaches 40 mmHg, the distal mean arterial pressure begins to decrease from the normal value. The target partial hemostatic pressure range is used to indicate that the balloon is in a partially inflated state, and some blood flow is still perfusing distal organs.

[0070] Specifically, this step is performed during parameter planning for partial occlusion strategies or weaning phases. Partial occlusion is necessary when prolonged occlusion may lead to ischemia and necrosis of distal limbs or organs. The system defines the complete occlusion point (i.e., the minimum effective hemostatic pressure value) determined in step S10402 as the highest point of this interval, meaning that exceeding this value initiates a complete occlusion state. Simultaneously, the system backtracks through the target dynamic pressure data to find the moment the balloon begins to function, i.e., the initial occlusion pressure value, and sets this as the lowest point of the interval. The thus determined target partial hemostatic pressure range covers the entire process from partial vascular obstruction to near-complete obstruction. Adjusting the pressure within this range allows for precise control of blood flow through the stenosis, helping healthcare professionals find a balance between controlling proximal bleeding and maintaining the basic metabolic needs of distal organs, achieving refined partial perfusion management.

[0071] In addition, the minimum effective hemostatic pressure value and the initial occlusion pressure value can be determined through the following methods.

[0072] Specifically, when building and populating the system's core database, the system analyzes synchronously acquired hemodynamic data for the currently selected target area and the set combination of operating parameters (specific heart rate and stroke volume). During the initial inflation phase of the balloon, distal blood flow maintains the baseline level for that combination (e.g., flow rate at 100% of the baseline value). As the infusion volume increases, the system monitors changes in the derivative of the flow rate curve. When the decrease in distal flow rate relative to the baseline value first exceeds a preset interference threshold (e.g., a flow rate decrease exceeding 5%), or when the distal pulse pressure gradient begins to narrow, the system determines that the balloon has formed an initial obstruction. At this point, the system immediately indexes the target dynamic pressure data corresponding to that moment (i.e., the calculated value representing the actual force on the vessel wall), locks it, and marks it as the "initial occlusion pressure value" under that specific combination of operating parameters. For example, when the infusion volume is 5 ml, the distal flow rate begins to decrease significantly, and the target dynamic pressure data at this time is found to be 40 mmHg; the system then marks 40 mmHg as the initial occlusion pressure value.

[0073] Subsequently, while maintaining the aforementioned target area and operating parameter combination, the system continues to track blood flow data as the infusion volume increases. When the distal flow velocity reading remains consistently stable at zero (or below a very small noise floor threshold), or the distal arterial pressure no longer exhibits a pulsatile waveform but decreases to a flat flow (mean systemic filling pressure), the system determines that a complete occlusion state has been achieved. The system captures the target dynamic pressure data corresponding to the instant when this zero flow velocity state is first reached. The system locks and marks the pressure value at this critical point as the "minimum effective hemostatic pressure value" under this specific operating parameter combination. For example, when the infusion volume increases to 15 ml, the distal flow velocity returns to zero, and the target dynamic pressure data at this time is found to be 130 mmHg; therefore, 130 mmHg is marked as this value.

[0074] Optionally, the hemostasis operation data also includes the amount of bleeding and the operation time. This protocol can also execute steps S110-S112. Step S110: Based on a preset bleeding volume grading standard, the bleeding volume is mapped to a bleeding control score; Among them, bleeding volume refers to the total volume of blood lost by the subject during the entire hemostasis process. For example, in a certain interventional emergency simulation, the cumulative bleeding volume recorded by the sensor was 450 ml. The preset bleeding volume grading standard refers to the hierarchical mapping rule set according to clinical pathophysiological characteristics or experimental design requirements to define the severity of different bleeding volumes. For example, bleeding volume less than 750 ml is set as the first-level low-risk interval, bleeding volume between 750 ml and 1500 ml is set as the second-level intermediate-risk interval, and bleeding volume greater than 1500 ml is set as the third-level high-risk interval. The bleeding control score refers to the quantitative value assigned by the system based on the position of bleeding volume in the preset bleeding volume grading standard, which is used to evaluate the effect of hemostasis on blood loss. For example, bleeding volume corresponding to the first-level low-risk interval is assigned a high score of 90 to 100 points, while bleeding volume corresponding to the third-level high-risk interval is assigned a low score of less than 60 points.

[0075] This step is performed during the data settlement phase after a single hemostasis operation, or in scenarios where the performance of an automated control algorithm is evaluated offline. Specifically, the system first obtains the cumulative bleeding volume during the hemostasis process. This value is then used as an input variable and substituted into a preset bleeding volume grading standard for retrieval and matching. This standard is typically constructed as a piecewise function or lookup table, establishing an inverse correlation between "bleeding volume" and "evaluation score." If the bleeding volume falls within the excellent range of low bleeding, the system outputs a higher score through a mapping function, indicating that the control strategy effectively reduced bodily damage. If the bleeding volume falls within the dangerous range of massive bleeding, the system maps a lower score. Through this step, the physical volume data is transformed into a dimensionless evaluation index that can be used for horizontal comparison, thus intuitively quantifying the effectiveness of the operation in the "blood preservation" dimension.

[0076] Step S111: Based on a preset operation duration threshold, determine the operation efficiency score corresponding to the operation duration; The operation time refers to the time span from when the system initiates the hemostasis procedure to when the system confirms that a stable hemostasis state has been achieved. For example, the time taken from when the balloon starts injecting fluid to when the distal blood flow reaches zero and remains stable is 12 minutes. The preset operation time threshold is a key time node value set based on the golden time window for emergency treatment to measure the speed of operation. For example, 5 minutes is set as the dividing line between efficient and inefficient operation, or 10 minutes is set as the limit of safe time to complete the operation. The operation efficiency score is a quantitative value generated by comparing the actual operation time with the preset operation time threshold. It is used to evaluate the agility of the hemostasis process. For example, a high score is obtained when the actual time is much lower than the threshold, and a low score is obtained when the actual time is much higher.

[0077] This step is executed after the system confirms hemostasis is complete and locks the timestamp. Specifically, the system extracts the operation time recorded for this task and compares it with a preset operation time threshold. The system typically has a pre-set linear decay model or a stepped deduction algorithm: if the operation time is less than the set optimal threshold, the system determines the operation is extremely agile and directly assigns a full score for operational efficiency; if the operation time exceeds the optimal threshold but does not reach the limit safety time, the system deducts points according to the excess time and a predetermined slope; if the operation time exceeds the limit safety time, the operation is deemed timed out and given a very low score or zero points. This step aims to quantify the operation's performance in terms of "timeliness," reflecting the system's or operator's response speed in emergency situations.

[0078] Step S112: The bleeding control score and the operation efficiency score are weighted according to preset weighting coefficients to obtain the operation score; Among them, the preset weight coefficient refers to the numerical factor that is set by humans to balance the relative importance of the bleeding control dimension and the operation efficiency dimension in the overall evaluation. Usually, the sum of the weight coefficients of the two dimensions is 1. For example, in a scenario that emphasizes rapid hemostasis, the weight of operation efficiency is set to 0.6 and the weight of bleeding control is set to 0.4. The operation score refers to the final result that represents the overall quality of a single hemostasis task after weighted calculation. For example, the score of 88 points calculated by combining the two indicators is used as the final rating basis for this operation.

[0079] This step, performed after obtaining the scores for the two independent dimensions mentioned above, is the comprehensive calculation stage for generating the final report. Specifically, the system retrieves the preset weighting coefficients configured for the current application scenario. These coefficients define the contribution percentage of "reducing bleeding" and "shortening time" under the current evaluation system. The system multiplies the calculated bleeding control score by the corresponding weighting coefficient to obtain a weighted score for the bleeding dimension; simultaneously, it multiplies the calculated operational efficiency score by the corresponding weighting coefficient to obtain a weighted score for the efficiency dimension. Subsequently, the system sums the two products to obtain a unique operational score. This operational score eliminates the one-sidedness of a single indicator and, together with the blocking operation judgment result, can serve as a quantitative indicator to evaluate the comprehensive performance of the user's hemostasis operation under different working conditions.

[0080] The training and evaluation device for balloon occlusion hemostasis in the embodiments of this invention is described below from the perspective of hardware processing. Please refer to [link to relevant documentation]. Figure 3 This is a schematic diagram of a physical device structure for a training and evaluation device for balloon occlusion hemostasis in this application embodiment.

[0081] It should be noted that, Figure 3 The structure of the training and evaluation device for balloon occlusion hemostasis shown is merely an example and should not impose any limitation on the functionality and scope of use of the embodiments of the present invention.

[0082] like Figure 3 As shown, the training and evaluation device for balloon occlusion hemostasis includes a CPU 301, which can perform various appropriate actions and processes based on a program stored in the read-only memory ROM 302 or a program loaded from the storage section 308 into the random access memory RAM 303, such as performing the methods described in the above embodiments. The RAM 303 also stores various programs and data required for system operation. The CPU 301, ROM 302, and RAM 303 are interconnected via a bus 304. An I / O interface 305 is also connected to the bus 304.

[0083] The following components are connected to I / O interface 305: input section 306 including audio input devices, push-button switches, etc.; output section 307 including a liquid crystal display (LCD) and audio output devices, indicator lights, etc.; storage section 308 including a hard disk, etc.; and communication section 309 including a network interface card such as a LAN (Local Area Network) card, modem, etc. Communication section 309 performs communication processing via a network such as the Internet. Drive 310 is also connected to I / O interface 305 as needed. Removable media 311, such as a disk, optical disk, magneto-optical disk, semiconductor memory, etc., are installed on drive 310 as needed so that computer programs read from them can be installed into storage section 308 as needed.

[0084] In particular, according to embodiments of the present invention, the processes described above with reference to the flowcharts can be implemented as computer software programs. For example, embodiments of the present invention include a computer program product comprising a computer program carried on a computer-readable medium, the computer program containing computer programs for performing the methods shown in the flowcharts. In such embodiments, the computer program can be downloaded and installed from a network via communication section 309, and / or installed from removable medium 311. When the computer program is executed by CPU 301, it performs the various functions defined in the present invention.

[0085] It should be noted that specific examples of computer-readable storage media may include, but are not limited to: electrical connections having one or more wires, portable computer disks, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM), flash memory, optical fiber, portable compact disc read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination thereof. In this invention, a computer-readable storage medium can be any tangible medium containing or storing a program that can be used by or in conjunction with an instruction execution system, apparatus, or device.

[0086] The flowcharts and block diagrams in the accompanying drawings illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present invention. Each block in a flowchart or block diagram may represent a module, program segment, or portion of code, which contains one or more executable instructions for implementing a specified logical function. It should also be noted that in some alternative implementations, the functions indicated in the blocks may occur in a different order than those shown in the drawings.

[0087] Specifically, the training and evaluation device for balloon occlusion hemostasis in this embodiment includes a processor and a memory. The memory stores a computer program, and when the computer program is executed by the processor, it implements the training and evaluation method for balloon occlusion hemostasis provided in the above embodiment.

[0088] In another aspect, the present invention also provides a computer-readable storage medium, which may be included in the balloon occlusion hemostasis training and evaluation device described in the above embodiments; or it may exist independently and not assembled into the balloon occlusion hemostasis training and evaluation device. The storage medium carries one or more computer programs that, when executed by a processor of the balloon occlusion hemostasis training and evaluation device, cause the balloon occlusion hemostasis training and evaluation device to implement the balloon occlusion hemostasis training and evaluation method provided in the above embodiments.

[0089] Those skilled in the art will understand that all or part of the processes in the methods of the above embodiments can be implemented by a computer program instructing related hardware. This program can be stored in a computer-readable storage medium, and when executed, it can include the processes described in the above method embodiments. The aforementioned storage medium includes various media capable of storing program code, such as ROM or random access memory (RAM), magnetic disks, or optical disks.

Claims

1. A training and assessment method for balloon occlusion hemostasis, characterized in that, The method includes: Based on the static and dynamic pressure data of the aorta of the simulated human, the hemostasis pressure range and partial hemostasis pressure range corresponding to different regions of the aorta under different operating combination parameters are calculated. The static pressure data is used to represent the vascular pressure of different regions of the aorta under different volumes of saline-filled balloons when the simulated human heart pumping mechanism is closed. The dynamic pressure data is used to represent the vascular pressure of different regions of the aorta under different volumes of saline-filled balloons under different operating combination parameters when the simulated human heart pumping mechanism is open. Based on preset bleeding case data, the simulator is controlled to run with a target running combination parameter to determine the bleeding status of the simulator. The target running combination parameter is any one of the plurality of different running combination parameters. Real-time data on hemostasis operations performed by the user on the aorta of the simulated human, including real-time occlusion location and real-time occlusion pressure; The target hemostasis pressure range and the target partial hemostasis pressure range are determined based on the target operating combination parameters and the real-time blocking position. The occlusion operation determination result is determined based on the target hemostasis pressure range, the target partial hemostasis pressure range, and the real-time occlusion pressure. The occlusion operation determination result includes: effective occlusion, partial occlusion, ineffective occlusion, and damaging occlusion.

2. The method according to claim 1, characterized in that, The calculation of the hemostasis pressure range and partial hemostasis pressure range for different regions of the aorta under different operating parameter combinations based on static and dynamic pressure data of the simulated human aorta, prior to which also includes: When the heart pumping simulation mechanism is turned off, the baseline static pressure data corresponding to the target area of ​​the aorta of the simulated human is collected, and the target area is any one of a plurality of preset areas; After placing the simulated balloon into the target area, several different preset volume values ​​of physiological saline were determined; The target volume value of physiological saline is injected into the simulated balloon multiple times, and corresponding sampling static pressure data are collected for each injection. The target volume value is any one of the multiple different preset volume values. The average static pressure data corresponding to the target volume value is obtained by averaging multiple sampled static pressure data. The difference between the average static pressure data and the basic static pressure data corresponding to the target area is calculated to obtain the target static pressure data corresponding to the target area under the target volume value.

3. The method according to claim 2, characterized in that, The calculation of the hemostasis pressure range and partial hemostasis pressure range for different regions of the aorta under different operating parameter combinations based on static and dynamic pressure data of the simulated human aorta, prior to which also includes: When the heart pumping simulation mechanism is activated, multiple different combinations of operating parameters for the simulated human are determined; When the simulated human is under the target operating parameters, the basic dynamic pressure data corresponding to the target region of the aorta of the simulated human are collected. The target region is any one of a plurality of preset regions. After placing the simulated balloon into the target area of ​​the aorta of the simulated human, several different preset volume values ​​of saline were determined; The target volume of physiological saline was injected into the simulated balloon multiple times, and corresponding dynamic pressure data were collected for each injection. The target volume was any one of the multiple different preset volume values. The average dynamic pressure data corresponding to the target volume value is obtained by averaging multiple sampled dynamic pressure data. Based on the difference between the average dynamic pressure data and the basic dynamic pressure data corresponding to the target area, the target dynamic pressure data corresponding to the target area under the target volume value when the simulated person is in the target operating combination parameters is obtained.

4. The method according to claim 3, characterized in that, The determination of the target hemostasis pressure range and the target partial hemostasis pressure range based on the target operating combination parameters and the real-time occlusion position specifically includes: For the target area, a static pressure curve of the target area is plotted based on the target static pressure data, and an extreme pressure point where the slope of the static pressure curve exceeds a preset safety threshold is selected, and the pressure value of the extreme pressure point is determined as the highest safe pressure value. The target hemostasis pressure range is determined by taking the highest safe pressure value as the upper limit of the range and the minimum effective hemostasis pressure value pre-marked in the target dynamic pressure data as the lower limit of the range. The minimum effective hemostatic pressure value is used as the upper limit of the range, and the pre-marked initial blocking pressure value in the target dynamic pressure data is used as the lower limit of the range to determine the target partial hemostatic pressure range.

5. The method according to claim 4, characterized in that, The determination of the occlusion operation judgment result based on the target hemostasis pressure range, the target partial hemostasis pressure range, and the real-time occlusion pressure specifically includes: When the real-time blocking pressure is less than the lower limit of the target part hemostasis pressure range, the blocking operation determination result is determined to be invalid blocking; When the real-time blocking pressure is greater than or equal to the lower limit of the target partial hemostasis pressure range and less than the upper limit of the target partial hemostasis pressure range, the blocking operation determination result is determined as the partial blocking. When the real-time blocking pressure is greater than or equal to the upper limit of the target hemostasis pressure range and less than or equal to the upper limit of the target hemostasis pressure range, the blocking operation determination result is determined as the effective blocking; When the real-time blocking pressure is greater than the upper limit of the target hemostasis pressure range, the blocking operation determination result is determined as the invasive blocking.

6. The method according to claim 1, characterized in that, After real-time acquisition of hemostasis operation data of the user on the aorta of the simulated human, the hemostasis operation data also includes blood loss and operation time, and the method further includes: Based on a preset blood loss grading standard, the blood loss is mapped to a blood loss control score; Based on a preset operation duration threshold, an operation efficiency score corresponding to the operation duration is determined; The blood loss control score and the operational efficiency score are weighted and calculated according to preset weighting coefficients to obtain the operational score.

7. The method according to claim 1, characterized in that, The method further includes: A flexible pressure sensor array is disposed on the inner and outer walls of the simulated human blood vessel; The flexible pressure sensor array collects the pressure type data corresponding to the user's hemostasis operation.

8. A training and assessment device for balloon occlusion hemostasis, characterized in that, The balloon occlusion hemostasis training and evaluation device includes: one or more processors and a memory; the memory is coupled to the one or more processors, the memory is used to store computer program code, the computer program code including computer instructions, and the one or more processors call the computer instructions to cause the balloon occlusion hemostasis training and evaluation device to perform the method as described in any one of claims 1-7.

9. A computer-readable storage medium comprising instructions, characterized in that, When the instruction is executed on a training and evaluation device for balloon occlusion hemostasis, the training and evaluation device for balloon occlusion hemostasis performs the method as described in any one of claims 1-7.

10. A computer program product, characterized in that, When the computer program product is run on a training and evaluation device for balloon occlusion hemostasis, the training and evaluation device for balloon occlusion hemostasis performs the method as described in any one of claims 1-7.

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