Field war wound rapid hemostasis experiment device

Abstract

The invention aims to provide a rapid hemostasis experiment device for on-site war wounds. The rapid hemostasis experiment device comprises a simulated blood circulation unit; a wound bleeding experiment module; the blood coagulation state regulation and control module is communicated with the simulated blood circulation unit and is used for regulating the addition amount of blood coagulation factors and anticoagulant substances in simulated blood according to the control signal and regulating the local fluid resistance of a simulated blood flow loop; the control input of the blood coagulation state regulation and control module comprises the simulated blood temperature parameter and the dilution degree parameter; a complex war wound scene of'high-pressure massive hemorrhage + low temperature + dilution + blood coagulation disorder + rebleeding test 'can be realistically reconstructed, objective and comparable quantitative evaluation can be carried out on different hemostasis schemes, and a unified experimental platform is provided for research, development and optimization of battlefield rapid hemostasis instruments.

Description

Technical Field

[0001] This invention belongs to the field of battlefield simulation training, and specifically relates to an experimental device for rapid hemostasis of combat wounds in the field. Background Technology

[0002] Massive hemorrhage in battlefield environments is one of the leading causes of combat casualty death. How to effectively stop bleeding in a very short time is a core issue in the field of combat wound care. To verify and optimize rapid hemostasis devices, materials, and procedures, clinical and research personnel have gradually conducted various bleeding simulations and hemostasis training exercises. Most existing combat wound simulation devices and hemostasis training models use silicone prostheses or human models, with internal simulated blood vessel tubing of fixed diameter. Colored fluid is delivered to the wound via an external reservoir and circulation pump to create a visual "bleeding effect" for teaching and skills training. Some devices incorporate simple pressure or flow sensors in the tubing to determine whether the tourniquet or bandage has effectively covered the bleeding point.

[0003] However, these traditional bleeding simulation devices have significant limitations in structure and function. First, most devices use fixed materials and have fixed compliance for the simulated blood vessels, and hemodynamics are usually provided by a pump with a constant rotation speed. This makes it impossible to simulate the dynamic changes in vascular compliance and mean arterial pressure during the early stages of trauma and the progression of blood loss, and it is also difficult to reflect the differences in hemodynamics among different individuals and at different stages of shock. Second, in terms of wound simulation, existing models are mostly single superficial wounds or single large blood vessel ruptures. They lack an integrated representation of multiple types and locations of combat injuries, such as superficial soft tissue bleeding, deep large blood vessel spurting bleeding, and occult bleeding in the abdominal cavity and pelvis. They cannot construct complex multi-source bleeding scenarios on a single platform.

[0004] Thirdly, regarding environmental factors and coagulation status, existing devices mostly use colored liquids without coagulation ability as "blood," focusing primarily on flow rate and visual effects. They lack systematic control over temperature, dilution, and coagulation factor levels, and also lack dynamic modeling of the coagulation process. This makes it difficult to simulate real physiological states such as hypothermia, dilutional coagulation dysfunction caused by large-volume infusions, and the effects of anticoagulants. In traditional systems, "stopping" is often achieved only by passively stopping the fluid or manually closing the valve, which is far removed from the actual "bleeding-coagulation-rebleeding" process.

[0005] Fourth, in terms of monitoring and evaluation, existing combat wound hemostasis training largely relies on instructors' subjective observation and experience-based scoring. Even when sensors are present, they are mostly used for simple functions such as whether a trigger has been activated or whether a certain pressure threshold has been reached. There is a lack of systematic collection of multi-dimensional data such as flow rate near the wound, cumulative blood loss volume, and pressure distribution at the wound interface. Furthermore, there is a lack of combining this data with mathematical models to form a unified comprehensive score that can be compared across materials and scenarios. Experimental results of different hemostatic instruments and materials are often scattered, incomparable, and difficult to trace, and cannot be precipitated into a searchable and reusable "response fingerprint" through model parameters.

[0006] Against this backdrop, there is an urgent need for a rapid battlefield hemostasis experimental device that can integrate on a single platform: adjustable simulated blood flow circulation, variable vascular compliance, multi-type wound modules, environmental temperature and dilution control, coagulation state regulation and kinetic modeling, multi-parameter sensor monitoring, and standardized scoring and parameter identification. This device must be able to realistically reconstruct complex battlefield wound scenarios involving "high-pressure massive hemorrhage + hypothermia + dilution + coagulation disorders + rebleeding testing," and also provide objective and comparable quantitative evaluations of different hemostasis methods, offering a unified experimental platform for the research and optimization of rapid battlefield hemostasis devices. Summary of the Invention

[0007] The purpose of this invention is to provide an experimental device for rapid hemostasis of battlefield wounds. This invention can realistically reconstruct complex battlefield wound scenarios such as "high-pressure massive bleeding + low temperature + dilution + coagulation disorder + rebleeding test", and can also provide objective and comparable quantitative evaluation of different hemostasis schemes, thus providing a unified experimental platform for the research and optimization of rapid hemostasis equipment for the battlefield.

[0008] To achieve the above objectives, the present invention provides the following technical solution, comprising: an experimental device for rapid hemostasis of battlefield wounds, used to experimentally evaluate the effectiveness of rapid hemostasis measures for battlefield wounds, characterized in that it comprises:

[0009] A simulated blood circulation unit includes a simulated blood storage container, a circulation pump, and a simulated blood vessel tubing. The circulation pump is connected to the simulated blood storage container and the simulated blood vessel tubing to form a closed simulated blood flow loop. The simulated blood vessel tubing is provided with a variable compliant blood vessel segment.

[0010] The wound bleeding experiment module is connected to the simulated blood vessel via a connecting pipe. The wound bleeding experiment module is equipped with multiple wound channels, and each wound channel is equipped with an independent valve to control the opening state and degree of the corresponding wound channel, so as to generate simulated bleeding of different forms and intensities.

[0011] An environment and dilution control module, which is connected to the simulated blood circulation unit, is used to adjust the temperature and dilution degree of the simulated blood, and output the simulated blood temperature parameters and dilution degree parameters to the control system.

[0012] A coagulation state control module, which is connected to the simulated blood circulation unit, is used to adjust the amount of coagulation factors and anticoagulants added to the simulated blood according to the control signal, and to adjust the local fluid resistance of the simulated blood flow circuit. The control input of the coagulation state control module includes the simulated blood temperature parameter and the dilution degree parameter.

[0013] The sensing and monitoring module is arranged on the simulated blood circulation unit and the wound bleeding experiment module. It is used to collect experimental data on simulated intravascular pressure, wound channel bleeding flow, cumulative blood loss volume and simulated blood temperature, and to collect interface pressure distribution data at the corresponding position on the wound surface.

[0014] An experimental control and evaluation module, electrically connected to the simulated blood circulation unit, the wound bleeding experiment module, the environment and dilution control module, the coagulation state regulation module, and the sensor monitoring module, is used for: sending control signals to the simulated blood circulation unit, the environment and dilution control module, the coagulation state regulation module, and the wound bleeding experiment module according to a set target combat injury experimental scenario; establishing the initial pressure of simulated blood flow, the simulated blood temperature, and the simulated blood dilution degree; and determining the combination of wound channels participating in the experiment and the corresponding bleeding intensity; receiving experimental data collected by the sensor monitoring module during the hemostasis experiment; determining the hemostasis onset time, residual bleeding flow after hemostasis, cumulative blood loss volume, number of rebleedings after hemostasis, and the quantity of hemostatic materials used; and combining the hemostasis onset time, residual bleeding flow after hemostasis, cumulative blood loss volume, number of rebleedings after hemostasis, and quantity of hemostatic materials used into a comprehensive score for rapid hemostasis capability according to a preset scoring function, and outputting the experimental results for evaluating the rapid hemostasis scheme in the tested field.

[0015] Furthermore, the variable compliance vascular segment includes a flexible inner tube and a rigid outer shell, with the flexible inner tube sleeved inside the rigid outer shell, forming a closed pressure chamber between them. The closed pressure chamber is connected to an adjustable pressure source via a catheter.

[0016] A first pressure sensor is arranged upstream of the variable compliance vascular segment, and a second pressure sensor is arranged downstream of the variable compliance vascular segment;

[0017] The experimental control and evaluation module sends a control signal to the adjustable pressure source based on the pressure difference measured by the first pressure sensor and the second pressure sensor and the target vascular compliance range, thereby adjusting the pressure inside the closed pressure chamber and adjusting the compliance of the flexible inner tube at different experimental stages, so that the variable compliance vascular segment exhibits predetermined vascular mechanical properties.

[0018] Furthermore, the wound bleeding experimental module includes a superficial soft tissue wound chamber, a deep large blood vessel wound chamber, and a hidden bleeding chamber;

[0019] The superficial soft tissue wound cavity is connected to the simulated blood vessel via multiple small-diameter connecting tubes to form a diffuse bleeding area;

[0020] The deep large blood vessel wound cavity is connected to the main trunk of the simulated blood vessel through a large-diameter connecting pipe, which is used to simulate the bleeding of a large blood vessel rupture.

[0021] The concealed bleeding chamber is connected to the simulated blood circulation unit via a slender, high-resistance connecting tube, used to simulate slow bleeding within the chamber;

[0022] The experimental control and evaluation module is configured to set the initial pressure and the opening degree of the corresponding wound channel in the connecting pipeline of the superficial soft tissue wound chamber, the deep large blood vessel wound chamber and the hidden bleeding chamber, respectively, so as to construct different types of combat wound bleeding experimental scenarios.

[0023] Furthermore, the outer surface of the superficial soft tissue wound cavity is covered with a simulated skin layer, and the interface pressure sensing array is disposed below the simulated skin layer, with multiple pressure sensing units of the interface pressure sensing array distributed in two dimensions in the wound area.

[0024] The experimental control and evaluation module calculates the pressure sufficiency index and pressure non-uniformity index based on the pressure distribution data output by the interface pressure sensor array, and uses the pressure sufficiency index and pressure non-uniformity index as one of the input parameters for the comprehensive score of rapid hemostasis capability, in order to evaluate the pressure quality of hemostasis measures in the wound area.

[0025] Furthermore, the environment and dilution control module includes a heat exchange unit, a temperature sensor, and a diluent injection unit disposed on the simulated blood storage container;

[0026] The heat exchange unit includes a heating device and a cooling device. The temperature sensor feeds back the simulated blood temperature to the experimental control and evaluation module. The experimental control and evaluation module controls the heating device and the cooling device to maintain the simulated blood temperature within a set range of 32 to 40°C.

[0027] The diluent injection unit includes a diluent storage container and a metering pump. Under the control of the experimental control and evaluation module, the metering pump injects diluent into the simulated blood storage container to obtain a simulated blood dilution degree in the range of 0-50%, and outputs the current dilution degree as a dilution degree parameter.

[0028] Furthermore, the experimental control and evaluation module uses the simulated blood temperature parameter and dilution parameter as environmental parameters to adjust the start and stop of the coagulation factor addition unit and anticoagulant addition unit in the coagulation state regulation module, as well as the injection rate, and to update the maximum reaction rate parameter, clot formation rate parameter and initial coagulation factor concentration in the coagulation kinetic model.

[0029] Furthermore, the coagulation state regulation module includes a coagulation factor addition unit connected to the procoagulant reservoir, an anticoagulant addition unit connected to the anticoagulant reservoir, and a throttling element arranged locally in the simulated blood circulation unit.

[0030] The experimental control and evaluation module is configured to control the injection time and injection volume of the coagulation factor addition unit and the anticoagulant addition unit at different experimental stages, and to control the opening of the throttling element to adjust the local coagulation factor concentration and local fluid resistance, thereby simulating normal coagulation function, weakened coagulation function and hypercoagulable state in simulated blood flow.

[0031] Furthermore, the experimental control and evaluation module incorporates a coagulation dynamics calculation unit, which uses a calculation method that includes the concentration of coagulation factors C. f (t) and clot volume V clot The system of differential equations (t) models the coagulation process, and the system of differential equations includes at least the following:

[0032] Equation of coagulation factor concentration change

[0033] Equation of change in volume of aggregate

[0034]

[0035] Where T is the simulated blood temperature parameter, D is the dilution degree parameter, τ(t) is the shear stress near the wound, and V max K m K c k form k lysis k shear The experimental control and evaluation module uses the numerical solution of the differential equation system combined with sensor monitoring data to determine the degree of clot formation and hemostasis status, which are the model parameters.

[0036] Furthermore, the sensing and monitoring module includes an arterial pressure sensor arranged on the simulated blood vessel trunk, a chamber pressure sensor arranged in the wound cavity, a flow sensor arranged at the outlet of each wound channel, and a weight sensor or liquid level sensor connected to a waste liquid collection container. The experimental control and evaluation module constructs bleeding flow-time curves and cumulative blood loss volume-time curves based on the data output by the flow sensor and the weight sensor or the liquid level sensor, and uses them to calculate the hemostasis onset time, the cumulative blood loss volume, and the residual bleeding flow after hemostasis.

[0037] Furthermore, the experimental control and evaluation module further includes a parameter identification unit and a hemostasis scheme fingerprint database.

[0038] The parameter identification unit is used to adjust the model parameters in the coagulation dynamics calculation unit with the measured wound bleeding flow-time curve and cumulative blood loss volume-time curve as target data, so that the error between the model output and the target data is reduced to a preset range, thereby obtaining the model parameter set of the rapid hemostasis scheme at the test site.

[0039] The hemostasis scheme fingerprint database is used to store model parameter sets and comprehensive scores of rapid hemostasis capabilities for multiple on-site rapid hemostasis schemes. After completing experiments on new on-site rapid hemostasis schemes, the model parameter sets of the new on-site rapid hemostasis schemes are compared with the existing model parameter sets in the hemostasis scheme fingerprint database for similarity comparison, which is used to classify and optimize the on-site rapid hemostasis schemes.

[0040] Beneficial effects

[0041] Compared with existing technologies, the on-site rapid hemostasis experimental device for combat wounds of the present invention has the following significant advantages through system design at the structural and modeling levels:

[0042] First, by combining a simulated blood circulation unit with a variable compliance vascular segment, a simulated blood flow environment was established that possesses both a closed-loop structure and adjustable hemodynamic characteristics. Through the design of a flexible inner tube, a rigid outer shell, and a closed pressure chamber, coupled with upstream and downstream pressure sensors and closed-loop control of an adjustable pressure source, vascular compliance can be dynamically adjusted during the experiment. This allows the simulated blood vessel to exhibit different states such as normal, contracted, and hardened at different stages, thus realistically simulating changes in vascular compliance and pressure during blood loss and shock, improving the realism and control precision of the experimental scenario at the hemodynamic level.

[0043] Secondly, through the hierarchical structural design of the superficial soft tissue wound chamber, the deep large blood vessel wound chamber, and the hidden bleeding chamber in the wound bleeding experimental module, and by setting independent connecting pipes and valves to control each chamber, this invention realizes a flexible combination of multiple types of wounds, such as diffuse superficial bleeding, high-flow large blood vessel jet bleeding, and hidden oozing within the cavity, on a single device. It can construct complex combat wound bleeding scenarios with multiple sources of bleeding, superficial and deep bleeding, and overt and hidden bleeding, which is significantly better than existing technologies with only a single wound model.

[0044] Third, by arranging an interface pressure sensor array under the simulated skin layer of a superficial wound, and having the experimental control and evaluation module calculate the sufficiency and unevenness of pressure, this invention quantifies the mass of pressure applied to the wound surface by hemostasis measures into measurable parameters. This allows for a direct reflection of whether the pressure coverage of a tourniquet, airbag patch, or finger pressure in space is sufficient and uniform. This information can not only serve as feedback for operational training but is also directly incorporated into the comprehensive score of rapid hemostasis ability, effectively solving the problem that the mass of pressure is difficult to quantify in existing training and can only be judged based on experience.

[0045] Fourth, through the coupled design of the environmental and dilution control module and the coagulation state regulation module, this invention can precisely control the temperature and dilution degree of simulated blood. Temperature and dilution parameters are input as environmental variables into the coagulation dynamics model and the factor / anticoagulant injection control logic, constructing an integrated "temperature-dilution-coagulation state" regulation mechanism. The device can simulate various states from undiluted at room temperature to weakened coagulation function and unstable clots under low temperature and high dilution conditions, realistically reproducing the impact of the "fatal triad" on hemostasis in battlefield treatment, significantly improving the reference value of experimental results under complex physiological conditions.

[0046] Fifth, by introducing a set of kinetic differential equations including coagulation factor concentration and clot volume into the experimental control and evaluation module, and combining shear stress and local pressure drop with the clot evolution process, this invention establishes a simplified coagulation mathematical model tightly coupled with sensor data at the experimental device level. This model can not only explain and predict the morphology of bleeding flow changes over time (such as rapid hemostasis, slow oozing, rebleeding, etc.), but also conduct "numerical experiments" by adjusting the environment and coagulation parameters to help understand the characteristics of different hemostasis measures in terms of clot formation speed, stability, and recurrence rate, which is not available in traditional purely mechanical simulation devices.

[0047] Sixth, by simultaneously arranging multiple sensors, such as arterial pressure sensors, cavity pressure sensors, wound flow sensors, and cumulative blood loss sensors, in the sensing and monitoring module, this invention can comprehensively record data from upstream blood supply pressure and local wound pressure to instantaneous bleeding flow, cumulative blood loss volume, and even residual bleeding after hemostasis. Combined with the scoring function in the experimental control and evaluation module, multiple indicators such as hemostasis onset time, cumulative blood loss, residual bleeding flow, number of rebleeding events, and quantity of hemostatic materials used are integrated into a rapid hemostasis capability score. This enables objective comparison of different hemostasis methods under a unified indicator system, overcoming the shortcomings of existing technologies that rely on subjective scoring by observers and the incomparability between different experiments.

[0048] Seventh, by establishing a parameter identification unit and a hemostasis scheme fingerprint database, this invention achieves "parametric profiling" of different rapid hemostasis schemes at the device level. The parameter identification unit fits coagulation dynamics model parameters based on measured bleeding flow and blood loss volume curves to obtain the model parameter set for a specific hemostasis scheme in a specific scenario, and stores it in the fingerprint database along with the corresponding score. In subsequent experiments, the parameter set of the new scheme can be compared with existing schemes in the fingerprint database to determine which strategy it is closer to in terms of mechanism and effect. This provides a unified and searchable quantitative basis for hemostasis product selection, strategy optimization, and evidence accumulation, which is something traditional experimental platforms and training models cannot provide.

[0049] In summary, this invention, through its overall design of "structural modules—environmental control—coagulation modeling—multi-parameter monitoring—comprehensive scoring—fingerprint recognition," not only achieves a realistic physical reproduction of the process of bleeding and hemostasis in combat wounds, but also constructs a self-consistent, computable, and comparable evaluation system, significantly improving the experimental capabilities and engineering application value of on-site rapid hemostasis solutions for combat wounds. Attached Figure Description

[0050] Figure 1 This is a block diagram of the overall structure of the experimental device for rapid hemostasis of battlefield wounds in this invention.

[0051] Figure 2This is a schematic diagram of the simulated blood circulation unit and the variable compliance vascular segment of the present invention. In the diagram, the simulated blood storage container 1 is located on the left side, its bottom connected to the inlet of the circulation pump 2 via a pipe. The outlet of the circulation pump 2 is connected to the system on the right side via the simulated blood vessel pipe 3, forming a closed simulated blood circulation loop. A variable compliance vascular segment 31 is located in the middle section of the simulated blood vessel pipe 3. A rigid outer shell is fitted over the flexible inner tube of the variable compliance vascular segment 31, forming a closed pressure chamber 32 between them. The closed pressure chamber 32 is connected to an adjustable pressure source 33 via a conduit. Pressure sensing positions P1 and P2 are respectively located upstream and downstream of the variable compliance vascular segment 31 to measure the pressure before and after this segment. The arrow points from the simulated blood storage container 1 through the circulation pump 2 to the simulated blood vessel pipe 3, and then through the variable compliance vascular segment 31, indicating that the simulated blood flows through the variable compliance vascular segment 31 under the drive of the circulation pump 2 to the subsequent modules.

[0052] Figure 3 This is a schematic diagram of the wound bleeding experimental module of the present invention. In the diagram, the overall outer frame is the wound bleeding experimental module 4, which contains, from left to right, a superficial soft tissue wound cavity 4a, a deep large blood vessel wound cavity 4b, and a hidden bleeding chamber 4c. The bottom of the superficial soft tissue wound cavity 4a is connected to the simulated blood vessel pipeline 3 via multiple small-diameter connecting pipes 41, forming a multi-point bleeding path. A simulated skin layer covers the superficial soft tissue wound cavity 4a, and an interface pressure sensor array 46 is arranged below the simulated skin layer. A hemostasis interface area 45 is set on the surface of the simulated skin layer for applying pressure hemostasis. The deep large blood vessel wound cavity 4b has a deeper cavity inside. Its lower part is connected to the main trunk of the simulated blood vessel pipeline 3 via a large-diameter connecting pipe 42, and its upper part has a wound channel. A wound channel valve 44 is installed at the wound channel for simulating large blood vessel rupture and bleeding, and controlling its opening and closing. The occult bleeding chamber 4c is connected to the simulated blood circulation unit via a slender, high-resistance connecting tube 43, and is used to simulate occult bleeding in cavities such as the abdominal cavity or pelvic cavity. The three chambers are connected to the simulated blood vessel tubing 3 via corresponding connecting tubes 41, 42, and 43, respectively, and the bleeding type and intensity are adjusted by opening and deflecting the wound channel valve 44.

[0053] Figure 4This is a schematic diagram showing the connection between the environment and dilution control module and the coagulation state regulation module of the present invention. In the diagram, the left rectangle represents the environment control section. The simulated blood storage container 1 is arranged inside the heat exchange unit 5, with the outer edge of the heat exchange unit 5 indicated by a dashed box. Heating device 51 and cooling device 52 are respectively arranged at the upper and lower parts of the heat exchange unit 5 for heating or cooling the simulated blood. The middle rectangle represents the diluent injection unit 6. A diluent storage container 61 and a metering pump 62 are arranged sequentially inside the diluent injection unit 6. The diluent storage container 61 is connected to the simulated blood storage container 1 via the metering pump 62, for injecting a predetermined volume of diluent into the simulated blood. The larger rectangle on the right represents the coagulation state regulation module 7. Module 7 contains a coagulation factor addition unit 7a and an anticoagulant addition unit 7b, arranged horizontally at the top. A throttling element 7c is arranged at the bottom of module 7 for adjusting the local hydraulic resistance of the simulated blood flow. On the right side of the figure, an experimental control and evaluation module 10 is set up, marked with a rectangle. Three arrows are drawn from the left edge of the experimental control and evaluation module 10, pointing to the environmental control part where the simulated blood storage container 1 is located, the diluent injection unit 6, and the coagulation state regulation module 7, respectively, indicating the unified control relationship of the experimental control and evaluation module 10 over the environmental temperature, dilution process and coagulation state.

[0054] Figure 5 This diagram illustrates the arrangement of the sensing and monitoring module of the present invention at a simulated blood circulation site and wound. In the diagram, the simulated blood storage container 1 is connected to the simulated blood vessel pipeline 3 via a circulation pump 2. An arterial pressure sensor 81 is mounted on the main branch of the simulated blood vessel pipeline 3 to measure the upstream simulated blood flow pressure in real time. The end of the simulated blood vessel pipeline 3 is connected to the wound bleeding experimental module 4. A flow sensor 82 is mounted on the outlet pipeline of the wound channel to measure the instantaneous bleeding flow rate at the wound. Below the simulated blood storage container 1, a waste fluid collection container 9 is connected via a pipeline. A cumulative blood loss sensor 83 is installed below the waste fluid collection container 9 to measure the cumulative blood loss volume in the waste fluid collection container 9. A simulated blood temperature sensor 84 is installed inside the simulated blood storage container 1 to measure the simulated blood temperature. An interface pressure sensor array 46, represented by a dashed rectangle, is arranged below the simulated skin layer of the superficial soft tissue wound chamber 4a to collect the interface pressure distribution on the wound surface when hemostasis measures are applied. The output signals of the above sensors are all collected by the sensor monitoring module and transmitted to the experimental control and evaluation module 10 for monitoring the hemostasis process and evaluating the results.

[0055] Figure 6This is a flowchart of the experimental method for rapid hemostasis of battlefield wounds in this invention. Five flowcharts, labeled S1 to S5, are arranged from top to bottom. Step S1 is the scenario setting step, where the experimental control and evaluation module 10 sets the initial pressure of simulated blood flow, simulated blood temperature, simulated blood dilution degree, and wound channel combination, and configures the initial value of coagulation state. Step S2 is the blood flow and bleeding initiation step, controlling the simulated blood circulation unit to establish the target simulated blood flow and controlling the wound bleeding experiment module to open the selected wound channel to form a predetermined bleeding intensity. Step S3 is the hemostasis application and data acquisition step, where the rapid hemostasis measures to be tested are applied to the interface area of ​​the hemostasis measures, while the sensor monitoring module collects pressure, flow rate, and cumulative data. The data includes accumulated blood loss volume, simulated blood temperature, and interface pressure distribution. Step S4 is the calculation of hemostasis indicators. The experimental control and evaluation module calculates indicators such as hemostasis onset time, accumulated blood loss volume, residual bleeding flow after hemostasis, and number of rebleedings after hemostasis based on the collected data. Step S5 is the scoring and fingerprint storage step. The experimental control and evaluation module generates a comprehensive score for rapid hemostasis capability based on a preset scoring function, identifies the parameters of the coagulation dynamics model, and stores the scoring results and model parameter groups into the hemostasis scheme fingerprint database for comparison and optimization of different rapid hemostasis schemes in different situations. Detailed Implementation

[0056] The following detailed description, in conjunction with the accompanying drawings and embodiments, provides a particularly detailed account of the "Experimental Device for Rapid Hemostasis of Battle Wounds in the Field" of the present invention. Those skilled in the art will understand that the following description represents preferred embodiments based on the claims, used to fully disclose the structure, control logic, and mathematical model of the present invention, and does not constitute a limitation on the scope of protection.

[0057] I. Overall System Structure and Working Approach

[0058] In a preferred embodiment, such as Figure 1 As shown, the field rapid hemostasis experimental device for combat wounds of the present invention includes a simulated blood circulation unit, a wound bleeding experimental module, an environment and dilution control module, a coagulation state regulation module, a sensor monitoring module, and an experimental control and evaluation module. Each module is connected by a liquid circuit and an electrical circuit to form a closed-loop system of "blood flow drive - environment regulation - coagulation response - wound bleeding - sensor monitoring - calculation evaluation".

[0059] The simulated blood circulation unit provides simulated blood flow with controllable pressure and flow, equivalent to the human cardiovascular system; the wound bleeding experiment module generates simulated bleeding of different forms and intensities in different chambers and channels, equivalent to the injured parts of the human body; the environment and dilution control module changes the temperature and dilution of the simulated blood to recreate common battlefield scenarios such as "hypothermia + large-volume infusion"; the coagulation state regulation module adjusts the coagulation rate and clot stability through chemical factor injection and throttling devices to achieve switching between multiple states such as "normal coagulation, coagulation disorder, and hypercoagulable state"; the sensing and monitoring module collects data such as pressure, flow, temperature, liquid level, and pressure distribution at the wound interface in real time; the experimental control and evaluation module, as the central control and computing unit, is responsible for coordinating the operation of each module, solving the built-in coagulation dynamics model, judging the hemostasis process, and outputting a comprehensive score of rapid hemostasis capability based on the scoring function, as well as the optional model parameter "fingerprint".

[0060] The entire system's operation can be summarized as follows: After setting a specific combat injury scenario (e.g., femoral artery tear combined with hypothermia and dilution conditions), simulated blood flow drives continuous bleeding from the wound, and then the on-site hemostasis measures to be tested are applied; during this process, environmental and dilution control, coagulation regulation, and throttling devices change the system state according to the control strategy, and sensors record pressure / flow / blood loss in real time; after the experiment, the rapid hemostasis capability of the hemostasis measures in the current scenario is quantitatively evaluated through the built-in mathematical model and scoring algorithm.

[0061] II. Structure and Parameters of the Simulated Blood Circulation Unit

[0062] In this embodiment, the simulated blood circulation unit is as follows: Figure 2 As shown, it mainly includes a simulated blood storage container, a circulation pump, simulated blood vessel tubing, and a variable compliance blood vessel segment.

[0063] The preferred container for the simulated blood is a transparent acrylic glass jar with a capacity of 2–5 L, filled with simulated blood. The simulated blood can be prepared by mixing distilled water, glycerol, and a thickener in a specific ratio, such as 60% water, 35% glycerol, and 5% polymeric thickener by volume, resulting in a dynamic viscosity of approximately 3–4 mPa·s at 37°C, close to that of human blood. The container has a filling port and a vent at the top, and graduations or a level sensor on the side wall to monitor the current volume of simulated blood. An outlet is located at the bottom of the container, connected to the inlet of a circulation pump.

[0064] The circulation pump can be a medical peristaltic pump, with an adjustable flow rate range of 0–3 L / min achieved by changing the pump tubing and adjusting the rotation speed. Under standard settings, the target mean arterial pressure can be set to 80–100 mmHg, corresponding to common pressure levels in large blood vessels such as the femoral artery; it can also be lowered to 30–60 mmHg to simulate post-hemorrhagic hypotension or venous pressure environments. To increase realism, the control system can periodically adjust the pump rotation speed around a reference value, generating a pulsed flow rate of 60–120 times / min, thus producing a pulsating pressure waveform in the simulated blood vessel tubing that closely resembles physiological patterns.

[0065] The simulated vascular tubing is constructed from medical-grade silicone tubing, with a mid-section inner diameter selectable at 6–10 mm and a wall thickness of approximately 1 mm, corresponding to a medium-diameter artery in the human body. The tubing connects to subsequent wound and environmental / coagulation modules via a tee connector and connecting tubing, forming a closed loop. A variable compliance vascular segment, approximately 100–200 mm in length, is incorporated in the middle of the main tubing. This segment consists of a flexible inner tube and a rigid outer shell. The inner tube is a thinner silicone tube, with a rigid transparent tube fitted around its periphery, forming a closed annular pressure chamber. This closed pressure chamber is connected to an adjustable pressure source (small air pump + pressure regulating valve + pressure sensor) via a small-diameter catheter. In the unpressurized state, the inner tube maintains its natural diameter. When gas is injected into the closed pressure chamber, the pressure in the outer chamber increases, causing radial compression of the inner tube and reducing its effective compliance. Conversely, when some gas is extracted to create a relative negative pressure, the inner tube expands slightly, increasing its effective compliance.

[0066] Upstream and downstream of the variable compliance vascular segment, first and second pressure sensors are installed respectively to measure the pressures Pup and Pdown in real time. The experimental control and evaluation module estimates the hydraulic resistance and volume change of this segment based on the pressure difference ΔP = Pup - Pdown and the output flow rate Q of the circulating pump (measured by the main flow sensor), and accordingly estimates the current compliance C = ΔVΔP. To achieve the target compliance trajectory (e.g., linearly decreasing from 1.2 mL / kPa to 0.6 mL / kPa within 0–60 s), the control module employs a closed-loop control strategy, periodically calculating the deviation between the current compliance and the target value, and adjusting the output pressure Pc of the adjustable pressure source through a PID control algorithm. Under a specific setting, the pressure chamber operating range can be set from -50 to 200 kPa, correspondingly achieving continuous adjustment of vascular compliance within the original range of approximately 0.5–2.0 mL / kPa, used to simulate different vascular states such as normal, spasmodic, and sclerotic.

[0067] Through the above structure and control, the simulated blood circulation unit can provide stable and controllable driving blood flow, and can also dynamically change vascular compliance during the experiment, so that the whole system presents a hemodynamic process similar to "early stability → mid-term compensation → late decompensation" on the time axis.

[0068] III. Structure and Bleeding Patterns of the Wound Bleeding Experiment Module

[0069] In the wound bleeding experimental module, this implementation is as follows: Figure 3 The diagram shows three types of functional chambers: a superficial soft tissue wound chamber, a deep large blood vessel wound chamber, and a hidden bleeding chamber. All three are connected in parallel to the simulated blood vessel trunk via branch lines and can be opened independently or in combination via control valves.

[0070] The superficial soft tissue wound chamber is a shallow, disc-shaped structure, with a planar dimension of, for example, 50mm × 50mm and a depth of approximately 10–15mm. The bottom is connected to simulated blood vessels via several small-diameter connecting tubes. These connecting tubes, with an inner diameter of, for example, 1–2mm, are evenly distributed at multiple points, equivalent to a cluster of terminal branches of small arteries / venules. Simulated blood seeps into the chamber through these small branches and flows out from the open wound surface at the top, forming diffuse oozing or low-velocity splashing under the combined effects of gravity and pressure. By adjusting the opening of the micro-needle valves on each branch, the bleeding intensity of each small vessel can be controlled, thus creating an overall bleeding pattern of "multiple superficial wounds." A simulated skin layer, approximately 2–3mm thick silicone sheet, is placed above the chamber, with an opening in the center to allow bleeding to flow through the simulated skin to the outside.

[0071] The deep major blood vessel wound chamber is a closed cavity with a volume of approximately 50–200 mL. Its bottom or sidewall is directly connected to the simulated blood vessel trunk via a large-diameter connecting tube (4–8 mm inner diameter), equivalent to a major blood vessel rupture. A single, relatively large wound channel (e.g., 4–6 mm in diameter) is located at the top of the chamber, leading to the simulated tissue surface. Initially, the wound channel is fully open, and simulated blood jets out under a pressure of 80–100 mmHg, with a flow rate reaching hundreds to thousands of mL / min, used to simulate severe combat injuries such as those to the femoral artery and brachial artery.

[0072] The occult bleeding chamber simulates the slow seepage of blood from the abdominal cavity, pelvic cavity, etc. Its volume can range from 100 to 300 mL, and it is connected to the simulated blood circulation unit via a slender, high-resistance connecting tube (inner diameter 1–2 mm, length 0.5–1 m). Simulated blood continuously flows into this chamber at a low flow rate and accumulates. The external surface may not have any obvious open wounds, or only a small amount of fluid may seep out through micropores, making it difficult to detect visually. By adjusting the opening of the valve on the connecting tube, different degrees of occult internal bleeding can be simulated.

[0073] Each wound cavity outlet (exposed point) is equipped with an independent wound access valve, preferably a direct-acting solenoid valve with a response time of less than 50ms. When the solenoid valve is fully open, it bleeds at maximum flow rate to the corresponding cavity. In the partially open state, the bleeding flow rate can be reduced proportionally by adjusting the opening degree, or it can be opened according to cardiac cycle pulses in the control program to achieve pulsatile spurting blood synchronized with the heartbeat. In actual experiments, the valve combination states of the superficial, deep, and concealed cavities can be set to various scenarios such as deep bleeding only, combined superficial and concealed bleeding, and simultaneous bleeding of all three, to simulate various combat injury combinations.

[0074] Beneath the simulated skin layer of a superficial soft tissue wound chamber, an interface pressure sensor array is uniformly arranged. The array comprises, for example, 4×4 thin-film pressure sensor units, covering the entire wound area. Each unit has a sensing area of ​​approximately 1 cm², a measurement range of 0–50 kPa, and outputs an analog voltage signal. When hemostatic measures (such as tourniquets, compression dressings, pneumatic pads, or finger pressure) are applied to the wound surface, each unit measures the local pressure value. The experimental control and evaluation module can then calculate the adequacy of compression (the proportion of the area with pressure exceeding a certain threshold to the effective wound area) and pressure non-uniformity (the ratio of the pressure standard deviation to the average value) to assess the quality of compression.

[0075] IV. Implementation of the Environment and Dilution Control Module

[0076] The environment and dilution control module is mainly used to reproduce common battlefield conditions such as low temperatures and blood dilution. In this embodiment, a flexible electric heating belt is wrapped around the outer wall of the simulated blood storage container, and a water cooling jacket is installed externally to form a two-way temperature regulation structure. The heating belt and cooling water pump are driven by the output control signal of the temperature controller, and the temperature sensor is installed in the middle of the storage tank to accurately measure the liquid temperature. The experimental control and evaluation module reads the temperature sensor signal and uses a PID control algorithm to maintain the simulated blood within the target temperature range. For example, the temperature is set to 37°C to simulate normal body temperature, or 35°C and 33°C to simulate mild to moderate low temperature conditions, respectively. The temperature control stability can reach ±0.2°C, and the response time (from room temperature to 35°C) is approximately 5 to 10 minutes.

[0077] The dilution control section includes a diluent storage tank (e.g., a 1L tank containing 0.9% NaCl solution) and a micro-peristaltic pump. The pump outlet is connected to the side wall interface of the simulated blood storage tank via an injection pipeline. Before the experiment begins, a dilution scheme can be set, such as "injecting the diluent at a rate of 10mL / s for the first 30 seconds, then stopping," with a total injection volume of 300mL, resulting in approximately 30% dilution of the original 700mL of simulated blood; or a scheme of "continuous injection at 5mL / s for 60 seconds throughout," with a total volume of 300mL, also achieving 30% dilution, but with a different time distribution. To accurately control the degree of dilution, the system can simultaneously use the storage tank level sensor and flow meter data to estimate the current total liquid volume, thereby calculating the dilution ratio D=V_original_blood / (V_original_blood + V_diluent). This value is input as an environmental parameter into the coagulation kinetic model, affecting parameters such as the initial concentration of coagulation factors Cf(0), the maximum reaction rate Vmax, and the clot formation rate kform.

[0078] In different experiments, temperature T and dilution ratio D can be set in combination to construct, for example, an ideal state of "37℃ + 0% dilution", a mildly disturbed state of "35℃ + 20% dilution", and a severe coagulation disorder state of "33℃ + 40% dilution", to examine the robustness of hemostasis measures under different environments.

[0079] V. Coagulation Status Regulation Module and Mathematical Model

[0080] The coagulation state regulation module includes a coagulation factor addition unit, an anticoagulant addition unit, and a throttling element in hardware, and a coagulation dynamics model and parameter management module in software.

[0081] The coagulation factor addition unit consists of a precision injection pump equipped with a procoagulant reservoir. The procoagulant can be a high-concentration calcium ion solution, a polymeric colloid simulating thrombin / fibrin function, or a platelet suspension containing microparticles. When accelerated coagulation is needed, the control module sends a command to the injection pump to introduce, for example, 1–5 mL of the procoagulant into the simulated blood at a given rate. The anticoagulant addition unit is similar, with a reservoir containing a solution of simulated heparin or other anticoagulants, which is injected into the circulation when a simulated anticoagulant state is required or when coagulation function is impaired.

[0082] The throttling element is a variable-aperture needle valve or an electrically controlled throttling valve arranged on the simulated blood vessel tubing. Its opening is adjusted by the control module to change the local flow velocity and shear force upstream of the wound. In some scenarios, the system can briefly increase the throttling opening during the observation period after clot formation to generate a shear impact to test the stability of the clot.

[0083] To characterize the coagulation process using a unified mathematical model, this embodiment implements the following set of differential equations in the experimental control and evaluation module. Let the local coagulation factor concentration be Cf(t), the clot volume be Vclot(t), the ambient temperature be T, and the dilution ratio be D, then:

[0084] The maximum reaction rate Vmax(T,D) in the coagulation factor kinetic equation varies with temperature T and dilution degree D, and is preferably expressed in the form of Arrhenius / Q10, for example:

[0085] Among them, V max,37 Q10 is the temperature sensitivity coefficient (e.g., 2.0) at 37°C and undiluted conditions, T is the current simulated blood temperature (in °C), and D is the dilution ratio (a dimensionless number between 0 and 1, where D=1 indicates undiluted).

[0086] The Michaelis constant Km is a parameter in the Michaelis–Menten model, used to characterize the concentration of coagulation factors at which the half-maximum reaction rate is reached.

[0087] The term S(t) represents the coagulation factor generation term caused by the injection of exogenous procoagulant reagent or simulated tissue release, which can be modeled according to the injection rate and duration of the procoagulant reagent in this invention.

[0088] The term Df(t) represents the amount of coagulation factor loss due to factors such as natural degradation, dilution, and blood flow erosion, and can preferably be approximated as:

[0089] Where kdeg is the natural degradation rate constant of coagulation factor, kwash is the effective concentration loss rate constant caused by blood flow erosion, and Cf(t) is the coagulation factor concentration at the current moment.

[0090] Bulk kinetic equation:

[0091] Wherein, kform(T,D) is the clot formation rate constant, which varies with temperature and dilution, generally reaching its maximum value at 37℃ in undiluted conditions; Kc is the concentration scale for clot formation; klysis(T) is the dissolution constant, which may decrease slightly at low temperatures; kshear is the shear sensitivity coefficient; and τ(t) is the local shear stress near the wound, which varies with local flow velocity and pipe diameter. To reflect the threshold effect of shear fracture, the critical shear τ can also be introduced. critWhen τ(t)≤τcrit, kshear is considered to be very small, resulting in only slow erosion; when τ(t)>τcrit, kshear is switched to a larger value, or a rapidly decaying "rupture pulse" is added to the equation - that is, at a certain moment tb triggers Vclot(tb^+)=βVclot(tb^-), where β<1 represents the proportion of remaining clots after rupture.

[0092] The local pressure drop Pdrop(t) is used to reflect the degree of clot blockage and can be defined as:

[0093]

[0094] Pblood(t) is measured by the upstream pressure sensor, and KP is a scaling volume constant related to the wound geometry. When Vclot→0, Pdrop≈0, and the wound is almost not blocked; when Vclot≫KP, Pdrop→Pblood, and the wound is almost completely blocked.

[0095] During actual operation, the experimental control and evaluation module performs numerical integration on the above equations at time steps Δt (e.g., 0.01–0.1 s), and compares the model output with sensor data (real-time flow rate, pressure drop) at each step. If the model predicts that the flow rate approaches zero and the measured flow rate also drops below the threshold, it can be determined that the bleeding has been stopped; if a sudden increase in flow rate and shear stress is subsequently detected, accompanied by a sharp decrease in Vclot in the model, a rebleeding event is determined to have occurred.

[0096] VI. Arrangement and Signal Acquisition of Sensor Monitoring Modules

[0097] The sensing and monitoring module includes an arterial pressure sensor, a chamber pressure sensor, a flow sensor, a cumulative blood loss sensor (liquid level or weight), a temperature sensor, and an interface pressure array. The arterial pressure sensor is installed near the outlet of the circulation pump on the simulated blood vessel trunk to monitor the upstream pressure supplied to the wound. The chamber pressure sensor is installed in deep and hidden chambers to monitor changes in intracavitary pressure as bleeding and coagulation fill the cavity; the range is selectable from 0 to 300 mmHg, with an optimal accuracy of ±1 mmHg. The flow sensor is installed on the outlet pipeline of each wound channel to measure the instantaneous flow rate at each bleeding point in real time; a suitable range is 0 to 2000 mL / min, with an optimal resolution of 1 mL / min. The cumulative blood loss sensor can be a weight sensor installed at the bottom of the waste fluid collection tank to calculate the total blood loss volume through real-time weighing, or a float level gauge can be used to record changes in the container's liquid level and then convert them into volume. The temperature sensor is arranged in the storage tank and the main circulation pipeline to provide feedback for the temperature control structure.

[0098] As previously described, the interfacial pressure array, located beneath the surface of a superficial wound, provides a two-dimensional measurement of the pressure distribution applied by hemostasis measures. All sensor signals are input to the experimental control and evaluation module via a multi-channel A / D converter. The sampling frequency is selected based on the signal type: pressure and flow signals can be set to 100Hz; liquid level and temperature signals can be set to 10Hz; and the interfacial pressure array to 10–20Hz. The collected data is used for both real-time display and subsequent scoring and model parameter identification.

[0099] VII. Experimental Control and Evaluation Module, Scoring and Parameter Identification

[0100] The experimental control and evaluation module can be implemented using an industrial control computer or an embedded control board in terms of hardware, and multiple functional modules can be built in terms of software, including a scenario setting module, a process control module, a data recording module, a coagulation model solving module, a scoring module, and a parameter identification and fingerprint database module.

[0101] In the scenario setting module, users can input or select specific combat injury scenarios through a graphical interface, such as "femoral artery tear + 35℃ + 40% dilution + superficial / deep / occult bleeding combination," etc. Based on this, the system automatically sets the target pressure of the circulation pump, temperature setpoint, dilution scheme (injection time and total amount), the wound cavity to be opened and its valve opening degree, and the initial coagulation state (e.g., setting Cf(0) and Vmax), etc. The process control module executes the control actions of each actuator according to the time axis and sensor feedback. The state machine can be divided into stages such as "bleeding initialization," "intervention of hemostasis measures," "observation period," and "shear impact test."

[0102] The data logging module records time-series data from various sensors and action events from each actuator to a log file. The coagulation model solving module performs numerical calculations on coagulation factors and clot volume in real-time or playback mode according to the differential equations given in the previous section, and outputs prediction curves such as Cf(t), Vclot(t), and Pdrop(t) for further analysis.

[0103] The scoring module provides a quantitative evaluation of the hemostasis process. For this current embodiment, the following scoring function can be defined:

[0104]

[0105] Where T is the time to hemostasis (the time from the onset of bleeding to the first drop in blood flow below the threshold), Vloss is the cumulative blood loss volume during the experimental period, Qres is the average residual oozing flow during the observation period, Nr is the number of rebleeding events, and Nm is the number of hemostatic materials used or the number of interventions. Weights w1 to w5 can be set according to the application scenario. For example, in battlefield hemostasis scenarios where "time is life," w1 can be larger; in scenarios where the overall blood loss is more important, w2 can be increased. For ease of interpretation, S can be normalized to a score of 0-100, with smaller values ​​indicating better hemostasis, or defined as Sgood=KS, where a larger value is better.

[0106] The parameter identification and fingerprint database module is used to extract a set of characteristic parameters for a specific rapid on-site hemostasis protocol from experimental data. This module uses the measured bleeding flow-time curve Q(t) and blood loss volume-time curve Vloss(t) as target data, calls the aforementioned coagulation kinetic model, and selects the parameter vector to be identified, for example...

[0107]

[0108] The parameter identification unit uses least squares or other numerical optimization algorithms to adjust the parameter vector θ so that the bleeding flow curve Qmodel(t;θ) and blood loss volume curve Vmodel(t;θ) output by the model are as close as possible to the measured curves.

[0109] In one specific implementation, an error function can be constructed:

[0110] Where ti is the i-th sampling time, N is the number of sampling points, and λ is a non-negative coefficient used to balance the weights of flow error and volume error. The parameter identification unit reduces the error function E(θ) to below a preset threshold through iterative solution. The parameter vector θ⋆ obtained at this time is regarded as the characteristic parameter set of the hemostasis scheme under the current combat injury experimental scenario, and serves as the "response fingerprint" of the scheme.

[0111] The system establishes a fingerprint database for each tested rapid on-site hemostasis protocol. Each record includes at least: the hemostasis protocol name, a summary of experimental scenario parameters, a comprehensive rapid hemostasis capability score S, and the corresponding parameter vector θ⋆. When testing new rapid on-site hemostasis protocols, the parameter identification and fingerprint database module first obtains a new parameter vector θnew based on the new experimental data. Then, it compares θnew with existing parameter vectors in the fingerprint database, for example, by calculating Euclidean distance or correlation coefficients. Based on the distance, it determines the category of existing protocols that are similar to the new protocol in terms of dynamic characteristics, thus providing a quantitative basis for the classification and optimization of rapid on-site hemostasis protocols.

[0112] VIII. Specific Numerical Examples: Femoral Artery Tear Combat Wound Scenario

[0113] In one specific embodiment, a femoral artery laceration was simulated in a battlefield environment. First, the simulated blood pressure was set to 90 mmHg, the simulated blood temperature to 35°C, and the dilution rate to 40% in the scenario setting module. The deep large vessel wound chamber (wound diameter 5 mm) was selected as the main bleeding chamber, and a small channel (diameter 2 mm) of the concealed bleeding chamber was opened to simulate accompanying internal bleeding. The initial flow rate of the circulation pump was set to approximately 1.5 L / min, corresponding to a measured main flow sensor reading of approximately 1500 mL / min.

[0114] At the start of the experiment, all coagulant and anticoagulant injection pumps were shut off, and the throttling element opening was neutral. The control module opened the wound valves in the deep and hidden chambers, and simulated blood was rapidly ejected through a 5mm diameter wound under a 90mmHg pressure in the main wound. The flow sensor recorded an initial flow rate of approximately 800mL / min in the main wound and approximately 80mL / min in the hidden wound. The cumulative blood loss volume increased rapidly on a second-by-second basis, reaching 60mL within 5 seconds and approximately 130mL within 10 seconds.

[0115] At the predetermined time t=10s, the system prompted the application of hemostasis measures. In this embodiment, a compression balloon patch was selected as the rapid hemostasis measure to be tested. The mechanical actuator completed the application at t≈12s, and then the control module started the patch inflation pump to slowly increase the interface pressure to approximately 70mmHg. The interface pressure array data showed that the pressure in most wound areas was higher than 60mmHg, the compression adequacy was approximately 92%, and the pressure non-uniformity was approximately 0.12. At the same time, at two time points t=13s and t=18s, the coagulation factor addition unit injected 1mL and 0.5mL of gel-promoting agent, respectively, to increase the local coagulation factor concentration Cf and enter the rapid coagulation stage.

[0116] Based on the aforementioned kinetic equations, the coagulation model within the control module predicted that Cf would gradually decrease from its initial value of Cf(0)≈1 unit to approximately 0.3 units within the 10–30 s interval, while Vclot would increase from 0 to approximately Vmax within the same timeframe, with the rate of increase gradually slowing down and stabilizing over time. Correspondingly, the measured flow rate at the main wound site decreased rapidly within 5 seconds after application, dropping below 5 mL / min at t≈28 s and remaining below 5 mL / min for more than 10 seconds. The system automatically recorded the hemostasis onset time as T=28 s. At this point, the cumulative blood loss volume Vloss≈230 mL, with a small amount of slow oozing still present in the hidden chamber, but the total amount was limited. During the observation period, the control module maintained a constant patch pressure, and the throttling element opening was slightly tightened to simulate mild spasm of the downstream blood vessels. No significant rebleeding occurred within the subsequent 5 minutes, and the flow sensor only recorded intermittent trace oozing of 1–3 mL / min.

[0117] To test clot stability, at t=5min, the control module briefly increased the circulation pump speed and opened the throttle valve, creating a high-shear impact where the shear stress τ exceeded the preset critical value τcrit. The model equation predicted a momentary increase in the kshearτVclot term, causing a rapid decrease in Vclot of approximately 10-20%, and a slight decrease in the local pressure drop Pdrop in the wound channel. In the measured data, the main wound flow rate suddenly increased from 0-3 mL / min to 40 mL / min within approximately 3 seconds, lasting for about 8 seconds, and then dropped again below 5 mL / min under continuous pressure and residual coagulation, without further increasing. The system therefore recorded a rebleeding event Nr=1, and considered the time when the flow rate dropped below the threshold for the second time as the "stable hemostasis completion" time.

[0118] After the experiment, the control module compiled the following data: hemostasis onset time T=28s, cumulative blood loss volume Vloss=230mL, average residual bleeding flow rate Qres≈3mL / min after stable hemostasis, number of rebleeding events Nr=1, and hemostatic material usage Nm=1 (using only one patch). Substituting the preset scoring parameters, such as w1=1, w2=0.2, w3=1, w4=7.5, w5=0, the following results were obtained:

[0119] S=1×28+0.2×230+1×3+7.5×1+0×1=84.5

[0120] If further converted to a "good" score of 0-100 through linear normalization, approximately 81.5 points can be obtained. The system simultaneously fits the coagulation model parameters through a parameter identification module to obtain the characteristic parameter set corresponding to this hemostasis protocol, for example... And so on, and stored in the fingerprint database. Compare with the fingerprints of a standard tourniquet protocol from previous experiments (e.g., θ). （tourniquet） The comparison revealed that the two were similar in kform and KP, but kshear was slightly larger. This indicates that the compression balloon patch is similar to the tourniquet in terms of clot formation ability and degree of blockage, but it is slightly more prone to partial rupture under high shear conditions, resulting in a slightly higher risk of rebleeding.

[0121] As can be seen from the above embodiments, the experimental apparatus provided by this invention can not only reconstruct complex combat injury scenarios including "high-pressure massive hemorrhage + low temperature + dilution + multi-source hemorrhage + rebleeding test", but also conduct in-depth and detailed quantitative analysis of different hemostasis measures using clear mathematical models and scoring standards. Those skilled in the art can adjust the size, materials, parameter ranges, and model form of each module according to specific needs, without departing from the essential spirit of this invention.

Claims

1. An experimental device for rapid hemostasis of battlefield wounds, used to experimentally evaluate the effectiveness of rapid hemostasis measures for battlefield wounds, characterized in that, include: A simulated blood circulation unit includes a simulated blood storage container, a circulation pump, and a simulated blood vessel tubing. The circulation pump is connected to the simulated blood storage container and the simulated blood vessel tubing to form a closed simulated blood flow loop. The simulated blood vessel tubing is provided with a variable compliant blood vessel segment. The wound bleeding experiment module is connected to the simulated blood vessel via a connecting pipe. The wound bleeding experiment module is equipped with multiple wound channels, and each wound channel is equipped with an independent valve to control the opening state and degree of the corresponding wound channel, so as to generate simulated bleeding of different forms and intensities. An environment and dilution control module, which is connected to the simulated blood circulation unit, is used to adjust the temperature and dilution degree of the simulated blood, and output the simulated blood temperature parameters and dilution degree parameters to the control system. A coagulation state control module, which is connected to the simulated blood circulation unit, is used to adjust the amount of coagulation factors and anticoagulants added to the simulated blood according to the control signal, and to adjust the local fluid resistance of the simulated blood flow circuit. The control input of the coagulation state control module includes the simulated blood temperature parameter and the dilution degree parameter. The sensing and monitoring module is arranged on the simulated blood circulation unit and the wound bleeding experiment module. It is used to collect experimental data on simulated intravascular pressure, wound channel bleeding flow, cumulative blood loss volume and simulated blood temperature, and to collect interface pressure distribution data at the corresponding position on the wound surface. An experimental control and evaluation module, electrically connected to the simulated blood circulation unit, the wound bleeding experiment module, the environment and dilution control module, the coagulation state regulation module, and the sensor monitoring module, is used for: sending control signals to the simulated blood circulation unit, the environment and dilution control module, the coagulation state regulation module, and the wound bleeding experiment module according to a set target combat injury experimental scenario; establishing the initial pressure of simulated blood flow, the simulated blood temperature, and the simulated blood dilution degree; and determining the combination of wound channels participating in the experiment and the corresponding bleeding intensity; receiving experimental data collected by the sensor monitoring module during the hemostasis experiment; determining the hemostasis onset time, residual bleeding flow after hemostasis, cumulative blood loss volume, number of rebleedings after hemostasis, and the quantity of hemostatic materials used; and combining the hemostasis onset time, residual bleeding flow after hemostasis, cumulative blood loss volume, number of rebleedings after hemostasis, and quantity of hemostatic materials used into a comprehensive score for rapid hemostasis capability according to a preset scoring function, and outputting the experimental results for evaluating the rapid hemostasis scheme in the tested field.

2. The experimental device for rapid hemostasis of battlefield wounds according to claim 1, characterized in that, The variable compliance vascular segment includes a flexible inner tube and a rigid outer shell. The flexible inner tube is fitted inside the rigid outer shell, and a closed pressure chamber is formed between the two. The closed pressure chamber is connected to an adjustable pressure source through a catheter. A first pressure sensor is arranged upstream of the variable compliance vascular segment, and a second pressure sensor is arranged downstream of the variable compliance vascular segment. The experimental control and evaluation module sends a control signal to the adjustable pressure source based on the pressure difference measured by the first pressure sensor and the second pressure sensor and the target vascular compliance range, thereby adjusting the pressure inside the closed pressure chamber and adjusting the compliance of the flexible inner tube at different experimental stages, so that the variable compliance vascular segment exhibits predetermined vascular mechanical properties.

3. The experimental device for rapid hemostasis of battlefield wounds according to claim 1, characterized in that, The wound bleeding experimental module includes a superficial soft tissue wound chamber, a deep large blood vessel wound chamber, and a hidden bleeding chamber. The superficial soft tissue wound cavity is connected to the simulated blood vessel via multiple small-diameter connecting tubes to form a diffuse bleeding area; The deep large blood vessel wound oral cavity is connected to the main trunk of the simulated blood vessel through a large-diameter connecting pipe, which is used to simulate the bleeding of a large blood vessel rupture. The concealed bleeding chamber is connected to the simulated blood circulation unit via a slender, high-resistance connecting tube, used to simulate slow bleeding within the chamber; The experimental control and evaluation module is configured to set the initial pressure and the opening degree of the corresponding wound channel in the connecting pipeline of the superficial soft tissue wound chamber, the deep large blood vessel wound chamber and the hidden bleeding chamber, respectively, so as to construct different types of combat wound bleeding experimental scenarios.

4. The experimental device for rapid hemostasis of battlefield wounds according to claim 3, characterized in that, The superficial soft tissue wound cavity exterior surface is covered with a simulated skin layer, and the interface pressure sensing array is disposed below the simulated skin layer. Multiple pressure sensing units of the interface pressure sensing array are distributed in two dimensions in the wound area. The experimental control and evaluation module calculates the pressure sufficiency index and pressure non-uniformity index based on the pressure distribution data output by the interface pressure sensor array, and uses the pressure sufficiency index and pressure non-uniformity index as one of the input parameters for the comprehensive score of rapid hemostasis capability, in order to evaluate the pressure quality of hemostasis measures in the wound area.

5. The experimental device for rapid hemostasis of battlefield wounds according to claim 1, characterized in that, The environment and dilution control module includes a heat exchange unit, a temperature sensor, and a diluent injection unit installed on the simulated blood storage container; The heat exchange unit includes a heating device and a cooling device. The temperature sensor feeds back the simulated blood temperature to the experimental control and evaluation module. The experimental control and evaluation module controls the heating device and the cooling device to maintain the simulated blood temperature within a set range of 32 to 40°C. The diluent injection unit includes a diluent storage container and a metering pump. Under the control of the experimental control and evaluation module, the metering pump injects diluent into the simulated blood storage container to obtain a simulated blood dilution degree in the range of 0-50%, and outputs the current dilution degree as a dilution degree parameter.

6. The experimental device for rapid hemostasis of battlefield wounds according to claim 5, characterized in that, The experimental control and evaluation module uses the simulated blood temperature parameters and dilution parameters as environmental parameters to adjust the start and stop of the coagulation factor addition unit and anticoagulant addition unit in the coagulation state regulation module, as well as the injection rate, and to update the maximum reaction rate parameter, clot formation rate parameter, and initial coagulation factor concentration in the coagulation kinetic model.

7. The experimental device for rapid hemostasis of battlefield wounds according to claim 1, characterized in that, The coagulation state regulation module includes a coagulation factor addition unit connected to the procoagulant reservoir, an anticoagulant addition unit connected to the anticoagulant reservoir, and a throttling element arranged locally in the simulated blood circulation unit. The experimental control and evaluation module is configured to control the injection time and injection volume of the coagulation factor addition unit and the anticoagulant addition unit at different experimental stages, and to control the opening of the throttling element to adjust the local coagulation factor concentration and local fluid resistance, thereby simulating normal coagulation function, weakened coagulation function and hypercoagulable state in simulated blood flow.

8. The experimental device for rapid hemostasis of battlefield wounds according to claim 7, characterized in that, The experimental control and evaluation module has a built-in coagulation dynamics calculation unit, which uses a method that includes coagulation factor concentration C. f (t) and clot volume V clot The system of differential equations (t) models the coagulation process, and the system of differential equations includes at least the following: Equation of coagulation factor concentration change Equation of change in volume of aggregate Where T is the simulated blood temperature parameter, D is the dilution degree parameter, τ(t) is the shear stress near the wound, and V max K m K c k form k lysis k shear The experimental control and evaluation module uses the numerical solution of the differential equation system combined with sensor monitoring data to determine the degree of clot formation and hemostasis status, which are the model parameters.

9. The experimental device for rapid hemostasis of battlefield wounds according to claim 1, characterized in that, The sensing and monitoring module includes an arterial pressure sensor arranged on the simulated blood vessel trunk, a chamber pressure sensor arranged in the wound cavity, a flow sensor arranged at the outlet of each wound channel, and a weight sensor or liquid level sensor connected to a waste liquid collection container. The experimental control and evaluation module constructs bleeding flow-time curves and cumulative blood loss volume-time curves based on the data output by the flow sensor and the weight sensor or the liquid level sensor, and uses them to calculate the hemostasis onset time, the cumulative blood loss volume, and the residual bleeding flow after hemostasis.

10. The experimental device for rapid hemostasis of battlefield wounds according to claim 8, characterized in that, The experimental control and evaluation module further includes a parameter identification unit and a hemostasis scheme fingerprint database. The parameter identification unit is used to adjust the model parameters in the coagulation dynamics calculation unit with the measured wound bleeding flow-time curve and cumulative blood loss volume-time curve as target data, so that the error between the model output and the target data is reduced to a preset range, thereby obtaining the model parameter set of the rapid hemostasis scheme at the test site. The hemostasis scheme fingerprint database is used to store model parameter sets and comprehensive scores of rapid hemostasis capabilities for multiple on-site rapid hemostasis schemes. After completing experiments on new on-site rapid hemostasis schemes, the model parameter sets of the new on-site rapid hemostasis schemes are compared with the existing model parameter sets in the hemostasis scheme fingerprint database for similarity comparison, which is used to classify and optimize the on-site rapid hemostasis schemes.

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