Interventional hemostasis compressor for angiography surgery

Abstract

The invention relates to the technical field of medical apparatus and instruments, and particularly discloses an interventional hemostasis compressor for angiography surgery, which realizes real-time acquisition of multi-dimensional signals of a hemostasis area, accurate positioning of a target spot and self-adaptive pressure regulation through the synergistic effect of an adaptive mechanism, a regulation unit and a feedback unit. The system has the functions of antibacterial protection, remote monitoring and emergency regulation and control, is convenient to operate and high in safety, can remarkably reduce the occurrence rate of complications such as postoperative bleeding and hematoma, and improves the accuracy and safety of hemostasis after an angiography operation.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, and particularly relates to an interventional hemostasis compressor for angiography surgery. BACKGROUND

[0002] Angiography surgery is an important interventional means for diagnosing and treating cardiovascular diseases. Through puncturing a peripheral blood vessel (such as a radial artery or a femoral artery) to send in a contrast catheter, lesion examination and treatment are completed under the guidance of imaging. Postoperative hemostasis treatment of the puncture site is a key link for the safety of the surgery. If hemostasis is not timely or compression is improper, complications such as hematoma and uncontrolled bleeding are easily caused, which seriously affects the recovery of the patient.

[0003] Currently, the interventional hemostasis compressors commonly used in clinical practice mainly include a manually adjustable compressor and a semi-automatic compression device. The manually adjustable compressor relies on medical personnel to judge the compression point and force according to experience, which is highly subjective and needs to be repeatedly adjusted, and the operation is complicated. The semi-automatic compression device can provide basic pressure adjustment, but lacks real-time monitoring of the hemostasis effect, and cannot dynamically adjust the compression parameters according to individual differences of the patient (such as blood vessel diameter and blood coagulation function), which has the risk of causing blood vessel injury due to excessive compression or bleeding due to insufficient compression.

[0004] To solve the above problems, we propose an interventional hemostasis compressor for angiography surgery. SUMMARY

[0005] The present application aims to provide an interventional hemostasis compressor for angiography surgery, which aims to solve the technical problems in the prior art.

[0006] In order to achieve the above object, an intervention hemostasis compressor for angiography surgery is adopted, comprising an adaptive mechanism, a control unit and a feedback unit, the adaptive mechanism comprises a support frame, a fitting ring, a shell and a control panel, the lower end of the support frame is fixedly provided with the shell, the inside of the shell is fixedly provided with the fitting ring, and the control panel is arranged on one side of the upper end of the support frame; the control unit and the feedback unit are arranged between the shell and the fitting ring; the control unit comprises a feedback processor, a positioning driving module, a pressure actuator and a signal receiver; the feedback unit comprises a blood flow monitoring sensor, a pressure sensing array and a temperature detector, the blood flow monitoring sensor is embedded in the inside of the fitting ring, the pressure sensing array is arranged on the fitting surface of the support frame and the fitting ring, and the temperature detectors are uniformly distributed on the inner wall of the fitting ring; the feedback unit is used for collecting blood flow velocity signals, real-time pressure signals and local temperature signals of a hemostasis area, outputting target point positioning information and pressure adjustment parameters based on multi-dimensional signal fusion analysis; the signal receiver in the control unit receives the target point positioning information and the pressure adjustment parameters, calibrates the compression target point through the positioning driving module, and the pressure actuator applies adaptive pressure to the hemostasis layer according to the pressure adjustment parameters.

[0007] Among them, the adaptive mechanism is the basis for the device to fit the patient's body and realize function integration, taking into account the fitting, stability and operation convenience, adapting to patients of different body types and different puncture sites, which is composed of a support frame, a fitting ring, a shell and a control panel: The support frame is the supporting core of the whole device, which is made of medical-grade high-strength lightweight alloy material, has rigidity and toughness, is light in weight and comfortable to wear, and can avoid compression damage to the patient's limbs caused by long-term wearing; the support frame comprises an arc-shaped clamping arm, an arc-shaped fitting plate and a standing frame, the arc-shaped clamping arm is arranged on the outer surface of the shell and is designed in an ergonomic arc shape, which can flexibly clamp the patient's limbs (such as arms and thighs), adapt to patients with different limb thicknesses, firmly clamp and not affect the blood circulation of the limbs; the arc-shaped fitting plate is fixed to the upper end of the shell close to the arc-shaped clamping arm, the part of the patient's skin is wrapped with flexible material to improve the wearing comfort and enhance the stability of the device to avoid displacement of the device; the standing frame is fixed above the arc-shaped fitting plate and can be used to fix bandages, catheters and other auxiliary medical components, which is convenient for the fixation and clinical operation of the device and further improves the clinical adaptability of the device.

[0008] The fitting ring is a core component in direct contact with the patient's puncture site to achieve hemostasis function. It adopts a layered design, taking into account hemostasis effect, antibacterial protection and pressure transmission performance. It is composed of a tourniquet, an anion antibacterial layer and a pressure transmission pad. The tourniquet is 2-3 mm thick and made of medical-grade flexible hemostatic material. It is soft, breathable, and can closely fit the puncture site to avoid pressure damage to the skin. It also has good hemostatic toughness to ensure the effectiveness of compression hemostasis. The anion antibacterial layer is fixed to the outer surface of the tourniquet and is made of silver ion modified non-woven fabric. Silver ions have high and broad-spectrum antibacterial properties, which can effectively inhibit the growth and reproduction of common pathogenic bacteria (such as Staphylococcus aureus and Escherichia coli) at the puncture site, reducing the risk of postoperative infection and meeting the needs of clinical sterile operation. The pressure transmission pad is fixed to the outer surface of the anion antibacterial layer and is made of flexible conductive material. It can evenly transmit the pressure applied by the pressure actuator to the tourniquet, ensuring uniform pressure on the puncture site and avoiding excessive or insufficient local pressure. It can also buffer pressure impact and improve patient tolerance. The fitting ring is designed to be detachable, allowing for quick replacement after use. The support frame and other components can be reused after sterilization, reducing medical costs and avoiding cross-infection and improving device reusability.

[0009] The shell is fixed to the lower end of the support frame and is made of medical-grade sealing material. It forms a sealed installation space inside to house the core components of the control unit and feedback unit, providing protection, dust and water resistance. It prevents impurities and liquids in the medical environment from damaging internal electronic components and isolates external interference to ensure stable signal transmission of the control unit and feedback unit. The control panel is located on one side of the upper end of the support frame, which is convenient for medical staff to operate. It integrates a display screen, a wireless transmitter and an emergency adjustment button to realize the integration of parameter display, remote monitoring and emergency control.

[0010] The feedback unit is the core of real-time monitoring and precise analysis. It can collect multi-dimensional physiological signals in the hemostatic area and output precise target positioning information and pressure adjustment parameters through signal fusion analysis, providing scientific basis for the adaptive control of the control unit and solving the technical defect of the lack of real-time feedback of existing devices. It is composed of a blood flow monitoring sensor, a pressure sensor array and a temperature detector, which work cooperatively and complementarily. The blood flow monitoring sensor is embedded in the inner part of the fitting ring, close to the tourniquet side. It can collect blood flow velocity signals in real time, with high accuracy and fast response, and can capture subtle changes in blood flow velocity. Through filtering processing of blood flow velocity signals, interference signals are removed and blood flow peak change rate is extracted. When the change rate is lower than the preset threshold, a preliminary hemostasis judgment signal is generated, providing a direct basis for hemostasis effect judgment and avoiding blind compression.

[0011] The pressure sensing array is arranged on the contact surface of the support frame and the contact ring in a uniform distribution, can collect real-time pressure signals of the puncture site in real time, accurately capture the distribution of the compression strength, construct a pressure-time curve, calculate the slope change of the curve, match the corresponding pressure adjustment gradient, judge whether the current compression strength is suitable for the individual needs of the patient, and avoid excessive or insufficient compression.

[0012] The temperature detectors are uniformly distributed on the inner wall of the contact ring, can collect local skin temperature signals of the puncture site in real time, reflect the skin tolerance and local blood circulation state of the patient; when the local temperature is higher than 37.5℃, it indicates that the puncture site may have abnormal conditions such as congestion and ischemia, triggering a pressure fine-tuning instruction to automatically reduce the compression strength by 5%-10%, relieving local discomfort, improving patient tolerance, and reducing the risk of vascular injury; multi-dimensional signal fusion analysis can realize comprehensive judgment of hemostatic effect, compression strength, and patient tolerance, and the output target positioning information and pressure adjustment parameters are more accurate and more in line with clinical actual needs.

[0013] The control unit is the core of "accurate positioning and self-adaptive control", receives the signals and parameters output by the feedback unit, drives the cooperative work of each component through closed-loop control logic, realizes compression target point calibration and pressure self-adaptive adjustment, and solves the technical defects of existing devices relying on manual adjustment and low control accuracy. It consists of a feedback processor, a positioning driving module, a pressure actuator, and a signal receiver: The signal receiver is responsible for receiving the target positioning information and pressure adjustment parameters output by the feedback unit, the signal transmission is stable and has strong anti-interference ability, ensuring that the parameter transmission is delay-free and deviation-free, and providing protection for the accurate control of the control unit.

[0014] The feedback processor, as the "core brain" of the control unit, uses a high-precision embedded processor with fast operation speed and accurate logic judgment, can receive the parameters transmitted by the signal receiver, combine the preset control algorithm, further analyze and optimize the target positioning information and pressure adjustment parameters, and output accurate control instructions to coordinate the cooperative work of the positioning driving module and the pressure actuator.

[0015] The positioning driving module includes an on-off module, an adjustment module, and an analysis module, with clear division of labor and rigorous logic: after the analysis module receives the target positioning information transmitted by the feedback processor, it quickly analyzes whether the current compression area accurately corresponds to the puncture target point and whether pressure adjustment is needed; if adjustment is needed, the on-off module is started to control the adjustment module to send adjustment signals to the feedback processor, and then the feedback processor sends accurate adjustment instructions to the pressure actuator, realizing real-time calibration of the compression target point and dynamic adjustment of the pressure, and ensuring accurate and deviation-free compression of the target point.

[0016] The pressure executor adopts medical-grade high-precision pressure driving components, has fast response speed and high adjustment precision, can accurately apply adaptive pressure according to the adjustment instructions sent by the feedback processor, and can reduce the pressure according to a preset gradient to avoid rebleeding caused by sudden pressure relief; the pressure executor cooperates with the pressure conduction pad to ensure that the pressure is uniformly conducted to the puncture site, and the hemostasis effect and patient tolerance are considered.

[0017] The various components of the control panel cooperatively realize parameter display, remote monitoring and emergency regulation, and improve the clinical operation convenience and safety of the device: The display screen is fixed on the side of the control panel away from the support frame, adopts a high-definition touch display screen, can display the target point coordinates, real-time pressure value, blood flow velocity, local temperature and hemostasis state in real time, and medical staff can intuitively master the patient's hemostasis situation without repeated inspection, saving labor cost; the display screen supports touch operation, can manually set parameters such as pressure threshold and hemostasis time, and adapts to individual needs of different patients.

[0018] The wireless transmitter is fixed on the side of the display screen, adopts a medical-grade wireless communication module, can establish stable data communication with a hospital medical terminal (such as a nurse station monitor, a doctor's mobile terminal), realize remote monitoring and remote parameter adjustment of hemostasis parameters; when the hemostasis state is abnormal, an alarm signal can be automatically sent to the medical terminal, medical staff can intervene in time to avoid sudden risks and improve the convenience and timeliness of clinical monitoring.

[0019] The emergency regulation button is arranged below the wireless transmitter and includes a pressure emergency key and a pressure relief key, which are suitable for emergency treatment of clinical emergencies: when the pressure emergency key is pressed, the pressure executor can quickly increase the compression force by 20% within 1-2 seconds to deal with sudden bleeding at the puncture site; when the pressure relief key is pressed, the pressure executor reduces the pressure by gradient until the safety threshold to deal with the situation of excessive compression of the patient's limbs such as numbness and ischemia, further improving the clinical safety of the device.

[0020] The interventional hemostasis compressor for angiography surgery of the application has a scientific and convenient use process, adapts to the clinical operation rhythm, and specifically includes the following steps: Preoperative preparation and device installation: according to the disease type and puncture site (such as radial artery, femoral artery) of the patient to be treated, the surgical incision position is determined, the arc-shaped clamping arm of the support frame is adjusted, the device is stably installed at the puncture site of the patient, the close-fitting ring is tightly attached to the puncture site, and the fixed bandage is passed through the vertical stand to ensure that the device is fixed firmly and does not shift.

[0021] Multi-dimensional signal fusion analysis, after the device is installed, the feedback unit is started, the blood flow monitoring sensor, the pressure sensing array and the temperature detector work synchronously to collect the blood flow velocity signal, the real-time pressure signal and the local temperature signal of the hemostasis area respectively; the blood flow velocity signal is filtered and processed to extract the blood flow peak change rate, the real-time pressure signal is combined to construct a pressure-time curve, the curve slope change is calculated, the pressure parameter is corrected through the temperature signal, multi-dimensional signal fusion analysis is completed, and target positioning information and pressure adjustment parameters are output.

[0022] Adaptive target calibration and pressure application, the signal receiver of the regulation unit receives the target positioning information and the pressure adjustment parameter, and transmits it to the feedback processor; after the feedback processor is analyzed and optimized, an instruction is sent to the positioning driving module, the analysis module of the positioning driving module judges whether the compression target is accurate, and the compression target is calibrated through the start-stop module and the adjustment module; after the calibration is completed, the feedback processor sends an adjustment instruction to the pressure actuator, and the pressure actuator applies adaptive pressure to the tourniquet through the pressure conduction pad according to the pressure adjustment parameter, so as to ensure that the compression force is uniform and the target is accurate.

[0023] Gradient pressure relief and hemostasis monitoring, after the pressure adjustment is completed, the device enters a continuous hemostasis monitoring state, the feedback unit collects real-time signals of each dimension, and the regulation unit dynamically adjusts the pressure according to the signal change; when the compression time exceeds 2 hours, the pressure actuator reduces the pressure according to the preset gradient: reduces the total compression force by 5% in 35 minutes, when the total compression force is reduced to 65% of the original force, reduces the current force by 15% in 20 minutes, when the current force is reduced to 40% of the original force, reduces the current force by 15% in 15 minutes, when the current force is reduced to 20% of the original force, removes the compression force completely after 30 minutes, avoids sudden pressure relief leading to rebleeding, and ensures rapid healing of the patient's wound.

[0024] Device disassembly and reuse processing, after hemostasis is completed, the device power is turned off, the arc-shaped clamping arm and the fixed bandage are loosened, and the device is removed; the detachable fitting ring is disassembled and destroyed; the support frame, the shell, the control panel and other reusable parts are disinfected with medical-grade disinfectant, and are stored after disinfection to facilitate subsequent reuse, reduce medical costs and avoid cross infection.

[0025] Beneficial effects: 1. The intervention hemostasis compressor for angiography surgery of the present application constructs a "feedback-regulation" closed loop system, realizes precise and intelligent hemostasis, and completely solves the technical pain points of the existing device relying on manual experience and low hemostasis precision. Through the blood flow monitoring sensor, pressure sensing array, and temperature detector of the feedback unit, multi-dimensional physiological signals of the hemostasis area can be collected in real time, and based on signal fusion analysis, precise target positioning information and pressure regulation parameters are output, avoiding subjective bias of manual judgment; the regulation unit accurately calibrates the compression target point through the positioning drive module, and the pressure actuator applies adaptive pressure, which can dynamically adjust the compression parameters according to individual differences and hemostasis state of the patient, realize "precise positioning and on-demand compression", effectively avoid blood vessel injury and limb ischemia caused by excessive compression, and complications such as bleeding and hematoma caused by insufficient compression, significantly improve the precision and safety of postoperative hemostasis, and have high clinical application value.

[0026] 2. The intervention hemostasis compressor for angiography surgery of the present application has strong adaptability and convenient operation, and takes into account practicality and reusability, which meets the clinical diagnosis and treatment needs. The support frame adopts ergonomic arc design, which can adapt to patients of different body types and different puncture sites, and is comfortable and fixed firmly. The fitting ring adopts detachable layered design, has hemostasis, antibacterial and pressure transmission functions, the silver ion antibacterial layer can effectively reduce the risk of postoperative infection, and the detachable design is convenient to replace. The support frame, shell and other components can be reused after disinfection, which not only reduces medical costs, but also avoids cross infection. The control panel integrates parameter display, remote monitoring and emergency regulation functions, so that medical staff can intuitively master the hemostasis state without repeated inspection. The wireless transmitter realizes remote monitoring and parameter adjustment, and the emergency adjustment button can cope with emergencies. The operation process is simple, and professional training is not required for skilled operation, which can greatly save medical manpower cost, improve clinical diagnosis and treatment efficiency, and is convenient for hospitals at all levels to promote and apply.

[0027] 3. The intervention hemostasis compressor for angiography surgery of the present application has high safety and low clinical risk, and has a perfect emergency protection mechanism, which meets the clinical safety requirements of medical devices. The patient's skin tolerance is monitored in real time through the temperature signal, and the pressure is automatically adjusted when the local temperature is abnormal, which improves the patient's tolerance. The pressure actuator adopts a gradient pressure relief mode to avoid rebleeding caused by sudden pressure relief and ensure rapid healing of the wound. The wireless transmitter can realize remote monitoring and abnormal alarm, and the emergency adjustment button can quickly respond to sudden bleeding and excessive compression, forming a comprehensive safety protection system. All components of the device are made of medical-grade materials, which are non-toxic, non-irritating and non-sensitizing, meet the biological compatibility requirements of medical devices, have extremely low clinical application risk, can effectively improve the clinical safety of angiography surgery, and promote the development of interventional medical technology. BRIEF DESCRIPTION OF DRAWINGS

[0028] In order to make the technical scheme of the embodiments of the present application or the prior art clearer, the accompanying drawings needed in the embodiments or prior art description will be briefly introduced. Obviously, the accompanying drawings in the following description only need to explain the embodiments of the present application, and other drawings can be obtained by those skilled in the art without any creative effort.

[0029] Figure 1 is a structural schematic diagram of an interventional hemostasis compressor for angiography surgery.

[0030] Figure 2 is a top view of an interventional hemostasis compressor for angiography surgery.

[0031] Figure 3 is a front view of an interventional hemostasis compressor for angiography surgery.

[0032] Figure 4 is a flow step diagram of an interventional hemostasis compressor for angiography surgery.

[0033] Figure 5 is a flow step diagram of a feedback unit signal fusion analysis process of the present application.

[0034] Figure 6 is a control logic block diagram of a feedback unit of the present application.

[0035] Figure 7 is a control logic block diagram of a regulation unit of the present application.

[0036] 1-adapter mechanism, 11-support frame, 111-arc-shaped clamping arm, 112-arc-shaped fitting plate, 113-stand, 12-fitting ring, 121-tourniquet, 122-anion antibacterial layer, 123-pressure transmission pad, 13-housing, 14-control panel, 141-display screen, 142-wireless transmitter, 143-emergency adjustment button, 2-regulation unit, 21-feedback processor, 22-positioning drive module, 221-start-stop module, 222-adjustment module, 223-analysis module, 23-pressure actuator, 24-signal receiver, 3-feedback unit, 31-calibration processor, 32-temperature control detector, 33-blood flow monitoring sensor, 34-pressure sensing array, 35-signal feedback module. DETAILED DESCRIPTION

[0037] In order to make those skilled in the art better understand the present application, the technical scheme of the present application will be further described below in combination with the accompanying drawings and embodiments.

[0038] Among them, the drawings are only used for illustrative description, and the representation is only a schematic diagram, not a physical diagram, and cannot be understood as a limitation on the present application; in order to better illustrate the embodiments of the present application, some components of the drawings will be omitted, enlarged or reduced, and do not represent the size of the actual product; for those skilled in the art, it is understandable that some well-known structures and their descriptions in the drawings can be omitted.

[0039] The same or similar reference numerals in the drawings of the embodiments of the present application correspond to the same or similar components; in the description of the present application, it should be understood that if the terms "upper", "lower", "left", "right", "inner", "outer" and the like indicate the orientation or positional relationship shown in the drawings, they are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, therefore the terms describing the positional relationship in the drawings are only used for illustrative description, and cannot be understood as a limitation on the present application, for those skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances.

[0040] In the description of the present application, unless otherwise explicitly specified and limited, if the term "connection" and the like appear to indicate the connection relationship between components, the term should be interpreted broadly, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication or interaction relationship between two components. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0041] As shown in Figures 1-7 The present application provides an interventional hemostatic compression device for angiography surgery, which aims to solve the technical problems of the hemostatic compression device for angiography surgery in the prior art, such as relying on manual experience, low hemostatic precision, lack of real-time feedback and dynamic regulation ability, high risk of complications, poor adaptability and complicated operation, and to realize precise, safe and convenient postoperative hemostasis, and to meet the urgent needs of clinical practice.

[0042] As shown in Figures 1-7 Each core component is first processed, and the processing precision and material performance are strictly controlled according to the medical grade standard, and then the whole assembly and debugging are carried out, so as to ensure stable operation, precision and safety of the device: 1. Process the adaptive mechanism 1: (1) Support frame 11: made of medical-grade high-strength lightweight aluminum alloy material, arc-shaped clamping arm 111 is ergonomically curved, with a radius of 120°-150°, which can adapt to patients with different limb thickness, and the clamping force can be manually adjusted; the arc-shaped fitting plate 112 is wrapped with medical-grade flexible silicone, with a thickness of 3-5 mm, which improves the wearing comfort; the through stand 113 is made of stainless steel material, with a height of 8-10 cm and a diameter of 2-3 mm, which ensures that the bandage and catheter can be stably worn, and the parts are welded and fixed, the surface is polished and rust-proof treated to ensure that there are no burrs and sharp corners to avoid damaging the patient's skin.

[0043] (2) Fitting ring 12: tourniquet 121 is made of medical-grade flexible hemostatic gauze material, with a thickness of 2-3 mm and a diameter of 5-8 cm, which is suitable for common puncture sites; anion antibacterial layer 122 is made of silver ion modified non-woven fabric material, with a silver ion content of 0.5-1.0 g / m², which ensures antibacterial effect while avoiding excessive silver ion stimulation of the skin, with a thickness of 1-2 mm; pressure transmission pad 123 is made of medical-grade silicone material, with a thickness of 2-3 mm and a hardness of Shore A 20-A30, which ensures uniform pressure transmission; tourniquet 121, anion antibacterial layer 122 and pressure transmission pad 123 are sequentially bonded and fixed to form a detachable fitting ring 12, which fits the mounting position of the shell 13, ensuring firm installation and convenient disassembly.

[0044] (3) Shell 13: made of medical-grade ABS sealing material, with a size suitable for support frame 11 and internal components, a thickness of 3-5 mm, and a reserved installation space for control unit 2 and feedback unit 3, with a sealing groove to ensure sealing performance and prevent impurities and liquids from entering; the surface of the shell 13 is sterilized and fixed to the lower end of the support frame 11 to ensure firm fixation and no looseness.

[0045] (4) Control panel 14: made of medical-grade ABS material to process the control panel shell, with a size of 10-12 cm x 8-10 cm x 2-3 cm; display screen 141 is a 2.8-inch high-definition touch display screen with a resolution of 320 x 240, supporting touch operation and parameter display; wireless transmitter 142 is a medical-grade Bluetooth 5.0 module with a transmission distance of not less than 10 m, supporting stable communication with medical terminals; emergency adjustment button 143 is a medical-grade waterproof button with pressure emergency key and pressure relief key, with a response time of ≤0.5 seconds; display screen 141, wireless transmitter 142 and emergency adjustment button 143 are integrated and installed inside the control panel 14 and connected with the internal circuit, and are fixed to one side of the upper end of the support frame 11 to ensure convenient operation and stable signal.

[0046] 2. Process control unit 2 and feedback unit 3: (1) Feedback unit 3: Blood flow monitoring sensor 33 selects a miniature ultrasonic blood flow sensor, with an accuracy of ≤0.1 cm / s and a response time of ≤100 ms. It is embedded in the inside of the fitting ring 12, close to one side of the tourniquet 121. The pressure sensor array 34 selects a micro piezoresistive pressure sensor, with a number of 6-8, evenly distributed on the fitting surface of the support frame 11 and the fitting ring 12, measuring range 0-100 kPa, accuracy ≤1 kPa. The temperature probe 32 selects a micro thermistor sensor, measuring range 32-42℃, accuracy ≤0.1℃, evenly distributed on the inner wall of the fitting ring 12, number of 4-6. Connect each sensor to the signal processing module, package and install between the shell 13 and the fitting ring 12, to ensure stable signal transmission and accurate detection.

[0047] (2) Control unit 2: Feedback processor 21 selects STM32L4 series embedded processor, with an operation speed of ≥80 MHz and support for multi-signal synchronous processing. The positioning drive module 22 is composed of an opening and closing module, an adjustment module, and an analysis module. It selects a micro relay and a high-precision adjustment chip, with a response time of ≤50 ms, and can realize accurate calibration of the target point. The pressure actuator 23 selects a micro electric push rod pressure actuator, with a stroke of 5-10 mm, a pressure adjustment range of 0-100 kPa, an adjustment accuracy of ≤1 kPa, and a response time of ≤500 ms. The signal receiver 24 selects a signal receiving module matched with the feedback unit, with strong anti-interference ability, ensuring no delay and no deviation in signal transmission. The feedback processor 21, positioning drive module 22, pressure actuator 23, and signal receiver 24 are integrated and installed inside the shell 13, connected with the feedback unit 3 and control panel 14 through the circuit, and a closed-loop control logic is constructed.

[0048] 3. Overall assembly and debugging: (1) Overall assembly: Fix the control unit 2 and the feedback unit 3 inside the shell 13, connect the circuits of each component, and ensure firm and short-circuit-free circuit connection. Install the detachable fitting ring 12 inside the shell 13, ensuring firm and tight fitting. Connect the control panel 14 with the internal circuit and fix it on the upper end of the support frame 11. Install the battery module, which selects a medical-grade lithium battery with a capacity of ≥2000 mAh and a continuous running time of ≥8 hours, supports charging, and ensures continuous and stable operation of the device. Complete the overall assembly and perform comprehensive sterile treatment on the surface of the device.

[0049] (2) Performance debugging: Debug the feedback unit 3, test the detection accuracy and response speed of the blood flow monitoring sensor 33, the pressure sensor array 34, and the temperature detector 32, ensure that the collected signals are accurate and stable, the signal fusion analysis logic is rigorous, and the output target positioning information and pressure regulation parameters are accurate; Debug the control unit 2, test the target calibration accuracy of the positioning driving module 22, the error is ≤0.5mm, test the pressure regulation accuracy and response speed of the pressure actuator 23, ensure that the adaptive control logic is smooth, the pressure is uniform, and the gradient pressure relief meets the preset requirements; Debug the control panel 14, test the parameter display effect of the display screen 141, the communication stability of the wireless transmitter 142, and the response speed and control effect of the emergency adjustment button 143, ensure that each function operates normally; Debug the overall sealing and stability of the device to ensure stable operation in a clinical environment without looseness or signal interference.

[0050] (3) Clinical simulation test: Choose a simulated human puncture model to simulate the hemostasis scene after radial artery and femoral artery puncture, test the fit, hemostasis effect and safety of the device; Simulate individual differences such as blood vessel diameter and coagulation function in different patients, test the adaptive control ability of the device to ensure that the compression strength adapts to different needs; Simulate sudden bleeding and excessive compression, test the control effect of the emergency adjustment button 143 to ensure that it can quickly respond to sudden risks; After multiple simulation tests, optimize the device parameters to ensure that the hemostasis accuracy, safety and convenience of the device meet clinical requirements, and the complication simulation rate is ≤0.5%.

[0051] In actual clinical application, taking radial artery angiography postoperative hemostasis as an example, the use process is as follows: S1: Device placement, after the patient completes the radial artery angiography surgery, the medical staff determines the puncture wound position, adjusts the arc-shaped clamping arm 111 of the support frame 11, and places the device stably at the puncture site of the patient's wrist, ensuring that the hemostat belt 121 of the fit ring 12 is tightly fitted with the puncture wound, and the fixed bandage is wound through the walking stand 113, ensuring that the device is fixed firmly and does not shift, and does not affect the patient's finger blood circulation.

[0052] S2: Signal acquisition and analysis, start the device power supply, the feedback unit 3 starts to work, the blood flow monitoring sensor 33 collects the blood flow velocity signal (cm / s) of the puncture site in real time, the pressure sensor array 34 collects the real-time pressure signal (the pressure between the contact part of the patient and the fitting ring 12), and the temperature detector 32 collects the local skin temperature signal; The device filters the blood flow velocity signal (collects the blood flow velocity signal in the hemostasis area, needs to accurately capture the blood flow peak change rate to judge the hemostasis effect, at the same time avoids the interference signals such as electromagnetic interference and skin contact noise in the medical environment, uses low-pass filtering as the basic filtering, adapts to the signal transmission characteristics of the miniature ultrasonic blood flow sensor (precision ≤0.1 cm / s, response time ≤100 ms)), extracts the blood flow peak change rate, and generates a preliminary hemostasis judgment signal (whether the current hemostasis effect meets the standard) when the change rate is lower than the preset threshold 0.3 cm / s; combined with the real-time pressure signal, a pressure-time curve is constructed (a corresponding two-dimensional curve graph is generated with time as the X axis and pressure as the Y axis), the curve slope change is calculated, and the corresponding pressure adjustment gradient is matched (when the curve slope of the N-1 min period is more than 25% than the curve slope of the N min period, the current 10% pressure will be increased, and when the curve slope of the N-1 min period is less than the curve slope of the N min period, the current 5% pressure will be reduced); when the local temperature is higher than 37.5℃, the signal feedback module 35 will send a pressure fine-tuning instruction to the signal receiver 24 after feedback, and then the signal receiver 24 will automatically reduce the compression force of the pressure actuator 23 by 5%-10%, thereby completing multi-dimensional signal fusion analysis, outputting target point positioning information and pressure adjustment parameters.

[0053] S3: Adaptive regulation, the signal receiver 24 of the regulation unit 2 receives the target point positioning information and the pressure adjustment parameters, and transmits them to the feedback processor 21; after analysis by the feedback processor 21, the feedback processor 21 sends an instruction to the positioning driving module 22, the analysis module of the positioning driving module 22 judges whether the compression target point is accurate, and calibrates the compression target point through the start-stop module 221 and the adjustment module 222 to ensure that the compression target point corresponds to the puncture wound accurately; after calibration, the feedback processor 21 sends an adjustment instruction to the pressure actuator 23, and the pressure actuator 23 applies adaptive pressure to the tourniquet 121 according to the pressure adjustment parameters through the pressure conduction pad 123, and the initial pressure is set to 30-40 kPa, ensuring that the compression force is uniform and the hemostasis is effective.

[0054] S4: Gradient pressure relief and monitoring. During the hemostasis process, the feedback unit 3 continuously collects signals in each dimension, and the control unit 2 dynamically fine-tunes the pressure. When the compression time exceeds 2 hours, the pressure actuator 23 reduces the pressure according to the preset gradient: reduce the total compression force by 5% every 35 minutes, and when the total compression force is reduced to 65% of the original force, reduce the current force by 15% every 20 minutes; when it is reduced to 40% of the original force, reduce the current force by 15% every 15 minutes; when it is reduced to 20% of the original force, remove the compression force completely after 30 minutes; medical staff can directly understand the hemostasis state through the display screen 141, and also can monitor remotely through the medical terminal. When an abnormality occurs, the device automatically alarms, and medical staff can intervene in time.

[0055] S5: Disassembly and reuse. After the hemostasis is completed and the blood flow speed is stable and there is no bleeding, turn off the power of the device, loosen the arc-shaped clamping arm 111 and the fixed bandage, and remove the device; disassemble the fitting ring 12 and perform centralized destruction treatment; the recycled parts such as the support frame 11, the shell 13, and the control panel 14 are subjected to overall disinfection with medical-grade alcohol 75%, and are stored in a sterile environment after disinfection, facilitating subsequent reuse.

[0056] Periodically maintain the device, check the connection of each part, tighten the loose parts in time; calibrate the sensors of the feedback unit 3 to ensure detection accuracy; check the battery endurance and charge in time; clean the impurities and stains on the surface of the device to ensure the sterile state and running stability of the device and prolong the service life of the device.

[0057] The above is only an embodiment of the present application, and the circuit, electronic components and modules involved are all prior art. Those skilled in the art can implement them without further description. The content protected by the present application does not involve improvement of software and methods. The specific structure and characteristics of the scheme known in the art are not described in detail here. Those skilled in the art know all the ordinary technical knowledge in the field of the application as of the filing date or the priority date, can know all the prior art in the field, and have the ability to apply conventional experimental means before that date. Those skilled in the art can improve and implement the present scheme based on their own ability under the guidance of the present application. Some typical known structures or methods should not be an obstacle for those skilled in the art to implement the present application. It should be noted that those skilled in the art can make several modifications and improvements without departing from the structure of the present application, which should be considered as the protection scope of the present application. These do not affect the effect and practicality of the present application.

Claims

1. An interventional hemostatic compression device for angiography surgery, characterized in that, It includes an adapter mechanism (1), a control unit (2) and a feedback unit (3). The adapter mechanism (1) includes a support frame (11), a fitting ring (12), a housing (13) and a control panel (14). The housing (13) is fixedly installed at the lower end of the support frame (11). The fitting ring (12) is fixedly installed inside the housing (13). The control panel (14) is located on one side of the upper end of the support frame (11). The control unit (2) and the feedback unit (3) are respectively disposed between the outer shell (13) and the fitting ring (12); The control unit (2) includes a feedback processor (21), a positioning drive module (22), a pressure actuator (23), and a signal receiver (24). The feedback unit (3) includes a blood flow monitoring sensor (33), a pressure sensor array (34), and a temperature detector (32). The blood flow monitoring sensor (33) is embedded inside the fitting ring (12). The pressure sensor array (34) is arranged on the mating surface of the support frame (11) and the fitting ring (12). The temperature detector (32) is evenly distributed on the inner wall of the fitting ring (12). The feedback unit (3) is used to collect blood flow velocity signals, real-time pressure signals and local temperature signals in the hemostasis area, and output target location information and pressure regulation parameters based on multi-dimensional signal fusion analysis. The signal receiver (24) in the control unit (2) receives target location information and pressure adjustment parameters, calibrates the compression target through the positioning drive module (22), and the pressure actuator (23) applies adaptive pressure to the hemostatic layer according to the pressure adjustment parameters.

2. The interventional hemostatic compressor for angiography surgery as described in claim 1, characterized in that, The support frame (11) includes an arc-shaped clamping arm (111), which is disposed on the outer surface of the outer shell (13). An arc-shaped bonding plate (112) is fixedly disposed on the upper end of the outer shell (13) near the arc-shaped clamping arm (111), and a through-stand (113) is fixedly disposed above the arc-shaped bonding plate (112).

3. The interventional hemostatic compressor for angiography surgery as described in claim 1, characterized in that, The fitting ring (12) includes a tourniquet (121), an anionic antibacterial layer (122) is fixedly disposed on the outer surface of the tourniquet (121), a pressure transmission pad (123) is fixedly disposed on the outer surface of the anionic antibacterial layer (122), the tourniquet (121) has a thickness of 2-3 mm, and the anionic antibacterial layer (122) is made of silver ion modified non-woven fabric.

4. The interventional hemostatic compression device for angiography surgery as described in claim 1, characterized in that, The control panel (14) includes a display screen (141), which is fixedly disposed on the inner side of the control panel (14) away from the support frame (11). The display screen (141) is used to display the target coordinates, real-time pressure value and hemostasis status.

5. The interventional hemostatic compressor for angiography surgery as described in claim 4, characterized in that, A wireless transmitter (142) is fixedly installed on one side of the display screen (141). The wireless transmitter (142) is used to establish data communication with the medical terminal to realize remote monitoring and parameter adjustment.

6. The interventional hemostatic compressor for angiography surgery as described in claim 5, characterized in that, An emergency adjustment button (143) is fixedly installed below the wireless transmitter (142). The emergency adjustment button (143) includes a pressure increase button and a pressure release button. When the pressure increase button is pressed, the pressure actuator (23) increases the pressure by 20% within 1-2 seconds. When the pressure release button is pressed, the pressure actuator (23) reduces the pressure in a gradient until the safety threshold is reached.

7. The interventional hemostatic compressor for angiography surgery as described in claim 1, characterized in that, The positioning drive module (22) includes an opening / closing module (221), an adjustment module (222), and an analysis module (223). After receiving the target location information from the feedback processor (21), the analysis module (223) analyzes whether the current area needs pressure adjustment. When adjustment is needed, the opening / closing module (221) is activated, and the opening / closing module (221) controls the adjustment module (222) to send an adjustment signal to the feedback processor (21). The feedback processor (21) then sends an adjustment command to the pressure actuator (23).

8. The interventional hemostatic compressor for angiography surgery as described in claim 1, characterized in that, Includes the following steps: S1: Determine the location of the surgical wound based on the type of illness of the patient to be treated, and place the device on the wound site; S2: After placement, the feedback signal from the feedback unit (3) is used for fusion analysis; S3: The control unit (2) receives the target location information and pressure adjustment parameters, calibrates the compression target through the positioning drive module (22), and the pressure actuator (23) applies adaptive pressure to the hemostatic layer according to the pressure adjustment parameters; S4: After the pressure is adjusted, the pressure actuator (23) will reduce the pressure in a gradient to ensure that the patient can heal the wound in a short time. S5: After hemostasis is completed, remove the device, replace the fitting ring (12), and disinfect the support frame (11), shell (13), control panel (14) and other reusable parts.

9. The interventional hemostatic compressor for angiography surgery as described in claim 8, characterized in that, The signal fusion analysis process of the feedback unit (3) includes: S201: Filter the blood flow velocity signal, extract the blood flow peak change rate, and generate a preliminary hemostasis judgment signal when the change rate is lower than a preset threshold. S202: Construct a pressure-time curve by combining real-time pressure signals, calculate the change in the curve slope, and match the corresponding pressure regulation gradient; S203: The pressure parameters are corrected by the temperature signal. When the local temperature is higher than 37.5℃, the pressure fine-tuning command is triggered to reduce the pressure by 5%-10%.

10. The interventional hemostatic compressor for angiography surgery as described in claim 8, characterized in that, The pressure actuator (23) reduces pressure in a gradient manner as follows: when the compression time exceeds 2 hours, the total pressure will be reduced by 5% over 35 minutes; when the total pressure is reduced to 65% of the original total pressure, the current pressure will be reduced by 15% over 20 minutes; when the total pressure is reduced to 40% of the original total pressure, the current pressure will be reduced by 15% over 15 minutes; when the total pressure is reduced to 20% of the original total pressure, the pressure on the patient will be removed after 30 minutes.

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