Bimodal blood pressure evaluation system for critical patient

Abstract

The invention discloses a bimodal blood pressure assessment system for critical patients, which belongs to the technical field of medical instruments and comprises an intelligent invasive blood pressure sensing device, a non-invasive blood pressure sensing device and a host processing unit. Wherein the invasive blood pressure sensing device comprises an artery puncture assembly and a pressure detection assembly, the pressure detection assembly is connected with the artery puncture assembly, and the invasive blood pressure sensing device is configured to detect a first pressure value through the pressure detection assembly after the artery puncture assembly is inserted into an artery; the non-invasive blood pressure sensing device is configured to be a flexible sensing module which can be worn on an artery body surface position and is used for detecting a second pressure value; the host processing unit is in signal connection with the invasive blood pressure sensing device and the non-invasive blood pressure sensing device, and the host processing unit is used for receiving the first pressure value or the second pressure value and calculating the blood pressure value. The bimodal blood pressure assessment system can provide reliable blood pressure information in different illness state stages or complex clinical scenes by adapting to blood pressure monitoring in different conditions.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a dual-modal blood pressure assessment system for critically ill patients. Background Art

[0002] At present, for clinically traumatic shock patients, especially those admitted to the emergency room or intensive care unit, it is crucial to quickly obtain their actual blood pressure. However, many patients have limb injuries and wear a lot of clothing, which makes it impossible to use traditional blood pressure cuff normally, and it is difficult to measure blood pressure in time in an emergency, delaying the judgment of the condition. On the other hand, for critically ill shock patients, if drugs such as norepinephrine that strongly constrict peripheral blood vessels need to be pumped in, the values obtained by using non-invasive blood pressure measurement methods on the periphery are often higher than the actual blood pressure, and cannot truly reflect the patient's blood pressure situation. In terms of invasive blood pressure monitoring, although invasive femoral artery pressure monitoring can obtain the patient's central pressure, before monitoring, complex femoral artery catheterization, connection of pressure sensors, and the provision of dedicated monitoring equipment (such as PICCO) are required. The operation is cumbersome and time-consuming, and may not be able to meet clinical needs in time in an emergency. And non-invasive blood pressure monitoring is prone to motion artifacts in the face of interference such as limb movement of patients, resulting in inaccurate measurement results. Existing blood pressure monitoring devices only have a single monitoring mode, and it is difficult to provide comprehensive, accurate and timely blood pressure information in different disease stages or complex clinical scenarios. Summary of the Invention

[0003] The object of the present invention is to solve the problem that existing blood pressure monitoring devices only have a single monitoring mode and it is difficult to provide comprehensive, accurate and timely blood pressure information in different disease stages or complex clinical scenarios, and to provide a dual-modal blood pressure assessment system for critically ill patients. An invasive blood pressure sensing device can be inserted into an artery by means of an arterial puncture assembly, and a first pressure value can be accurately detected by a pressure detection component. The non-invasive blood pressure sensing device is a flexible sensing module that can be worn on the surface position of the artery to detect a second pressure value. The host processing unit is signal-connected to the invasive blood pressure sensing device and the non-invasive blood pressure sensing device, and can receive and calculate pressure values from different sources to obtain blood pressure values, which can adapt to blood pressure monitoring in different situations and can provide reliable blood pressure information in different disease stages or complex clinical scenarios.

[0004] To achieve the above object, the present invention adopts the following technical solutions: According to a first aspect of the present invention, there is provided a dual-modal blood pressure assessment system for critically ill patients, comprising: An invasive blood pressure sensing device, the invasive blood pressure sensing device includes an arterial puncture assembly and a pressure detection component, the pressure detection component is connected to the arterial puncture assembly, and the invasive blood pressure sensing device is configured to insert into an artery through the arterial puncture assembly and then detect a first pressure value through the pressure detection component; A non-invasive blood pressure sensing device, the non-invasive blood pressure sensing device configured to be wearable at an arterial body surface position for a flexible sensing module that detects a second pressure value; A host processing unit, the host processing unit being respectively signal-connected to the invasive blood pressure sensing device and the non-invasive blood pressure sensing device, the host processing unit being configured to receive the first pressure value or the second pressure value and calculate a blood pressure value.

[0005] Further, the arterial puncture assembly includes an arterial puncture needle, the pressure detection assembly includes a pressure sensor, the pressure sensor is disposed at the tip of the arterial puncture needle, and the pressure sensor is configured to detect the first pressure value based on arterial blood flow.

[0006] Further, the arterial puncture needle includes a double-lumen needle body structure, an intelligent hemostatic valve, and a puncture limiter. The double-lumen needle body structure is provided with a first cavity and a second cavity. A guide wire for guiding the arterial puncture needle into the artery is disposed in the first cavity, and the pressure sensor is disposed in the second cavity. The inner diameter of the first cavity is greater than the inner diameter of the second cavity; the intelligent hemostatic valve is configured to prevent blood from entering the first cavity; the puncture limiter is configured to limit the maximum puncture depth of the arterial puncture needle.

[0007] Further, the invasive blood pressure sensing device further includes a self-adhesive fixing patch, the self-adhesive fixing patch being fixedly connected to the arterial puncture needle, and the self-adhesive fixing patch being configured to fix the arterial puncture needle at an arterial body surface position when the invasive blood pressure sensing device is operating.

[0008] Further, the non-invasive blood pressure sensing device includes an adaptive wristband and a sensor array. The adaptive wristband has an inner side and an outer side disposed opposite to each other. When the adaptive wristband is worn at an arterial body surface position, it contacts the arterial body surface position of the limbs through the inner side, and the sensor array is disposed on the inner side of the adaptive wristband to detect the second pressure value.

[0009] Further, the sensor array is provided with arranged in a manner of

[0010] a plurality of piezoelectric sensing units and Doppler blood flow probes arranged in a certain way. The pressure sensing unit is configured to capture the pressure fluctuation signal of the artery, and the Doppler blood flow probe is configured to detect the blood flow velocity of the artery through an ultrasonic beam. Further, the sensor array has multiple working modes, and the working modes at least include a first working mode, a second working mode, and a calibration mode. When the sensor array is in the first working mode, the second pressure value is detected through two diagonally arranged piezoelectric sensing units. When the pressure sensor is in the second working mode, through One of the piezoelectric sensing units detects the second pressure value, and when the sensor array is in the calibration mode, the second pressure value is corrected by the blood flow velocity detected by the Doppler blood flow probe.

[0011] Furthermore, the host processing unit includes a signal calibration module configured to eliminate the invasive catheter resonance effect generated by the invasive blood pressure sensing device or eliminate the non-invasive motion artifact generated by the non-invasive blood pressure sensing device.

[0012] Furthermore, the host processing unit has multiple monitoring modes, and the monitoring modes at least include an invasive monitoring mode, a non-invasive monitoring mode, and a dual-mode monitoring mode. When the host processing unit is in the invasive monitoring mode, it only receives the first pressure value fed back by the invasive blood pressure sensing device. When the host processing unit is in the non-invasive monitoring mode, it only receives the second pressure value fed back by the non-invasive blood pressure sensing device. When the host processing unit is in the dual-mode monitoring mode, it simultaneously receives the first pressure value and the second pressure value.

[0013] Furthermore, the host processing unit includes a data fusion module configured to create a blood pressure dynamic association model based on the first pressure value and the second pressure value when the host processing unit is in the dual-mode monitoring mode, and output a third pressure value according to the blood pressure dynamic association model.

[0014] Advantages of the present invention: The invasive blood pressure sensing device is inserted into the artery through the arterial puncture assembly, and the pressure detection assembly is used to accurately detect the first pressure value. For critically ill shock patients using vasoconstrictive drugs, it can provide the true central pressure, solving the problem of distorted non-invasive measurement values. The non-invasive blood pressure sensing device, as a flexible sensing module, can be directly worn on the surface position of the artery for patients with limb mutilation injuries or those with too many clothes to use traditional cuffs to detect the second pressure value, and can quickly obtain preliminary blood pressure data to avoid delaying the judgment of the condition. The host processing unit is signal-connected to the invasive blood pressure sensing device and the non-invasive blood pressure sensing device, and can flexibly select the monitoring mode according to different disease stages. In the stable stage of the disease, the non-invasive monitoring mode can achieve long-term continuous monitoring with little trauma to the patient. In the critical stage of the disease, when high precision of blood pressure is required, the invasive monitoring mode can provide accurate data. In complex clinical scenarios, the dual-mode monitoring mode is activated, and the host processing unit simultaneously receives the two pressure values, and the data fusion module creates a blood pressure dynamic association model to output a more accurate third pressure value, providing reliable blood pressure information for medical staff comprehensively, accurately and in a timely manner.

[0015] The above invention content is only an overview of the technical solution of the present invention. In order to understand the technical means of the present invention more clearly, it can be implemented according to the content of the specification. And in order to make the above and other purposes, features and advantages of the present invention more obvious and understandable, the following specific embodiments of the present invention are specifically given. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Other features, objects and advantages of the present invention will become more apparent by reading the detailed description of the non-limiting embodiments with reference to the following drawings. The drawings are only for the purpose of showing the preferred embodiments and are not considered to be a limitation of the present invention. Moreover, throughout the drawings, the same reference numerals are used to represent the same components.

[0017] Figure 1 It is a schematic structural diagram of a dual-modal blood pressure assessment system for critically ill patients disclosed in an embodiment of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0018] In order to make the purpose, technical solution and advantages of the present invention clearer and clearer, the present invention will be further described in detail below with reference to the drawings and embodiments. It should be understood that the specific embodiments described here are only the best embodiments of the present invention, only used to explain the present invention, and do not limit the protection scope of the present invention. All other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present invention.

[0019] Before discussing the exemplary embodiments in more detail, it should be mentioned that some exemplary embodiments are described as processes or methods depicted as flowcharts. Although the flowcharts depict the operations (or steps) as being processed sequentially, many of the operations (or steps) can be processed in parallel, concurrently or simultaneously. In addition, the order of the operations can be rearranged. The process can be terminated when its operations are completed, but there can also be additional steps not included in the drawings; the process can correspond to a method, function, procedure, subroutine, subprogram, etc.

[0020] Embodiment: According to the first aspect of this embodiment, a dual-modal blood pressure assessment system for critically ill patients is provided, as Figure 1As shown, it includes an invasive blood pressure sensing device 10, a non-invasive blood pressure sensing device 20 and a host processing unit 30. Among them, the invasive blood pressure sensing device includes an arterial puncture component 11 and a pressure detection component 12, the pressure detection component is connected to the arterial puncture component, and the invasive blood pressure sensing device is configured to detect a first pressure value through the pressure detection component after the arterial puncture component is inserted into the artery; the non-invasive blood pressure sensing device is configured as a flexible sensor module 21 that can be worn on the surface of the artery for detecting a second pressure value; the host processing unit is respectively connected to the invasive blood pressure sensing device and the non-invasive blood pressure sensing device, and the host processing unit is used to receive the first pressure value or the second pressure value and calculate the blood pressure value.

[0021] In this embodiment, the non-invasive blood pressure sensing device is used as a flexible sensing module that can be worn on the surface of the artery. Without wrapping a cuff, the non-invasive blood pressure of the limbs can be sensed by feeling the pressure. It greatly improves the timeliness of obtaining the patient's basal blood pressure, and can provide key guidance for clinical diagnosis and treatment at the first time. For critically ill patients with shock who need to strongly contract peripheral blood vessels, the traditional peripheral non-invasive blood pressure measurement will be higher than the actual blood pressure and cannot reflect the real situation. In this embodiment, the femoral artery cannulation and pressure suit provided by the invasive blood pressure sensing device can quickly complete the femoral artery cannulation, and the femoral artery pressure can be accurately obtained through the pressure detection component, that is, reflecting the patient's central pressure. This effectively overcomes the problem of peripheral blood pressure measurement distortion caused by vasoactive drugs, provides medical staff with real and reliable blood pressure values ​​of patients, helps to accurately assess the condition and formulate scientific treatment plans, and improves the level of treatment for such critically ill patients. Through the two methods of invasive blood pressure sensing device and non-invasive blood pressure sensing device, the host processing unit receives and processes pressure values ​​from different sources to calculate the blood pressure value, meeting the needs of different stages of the disease and scenarios. The non-invasive method is used for preliminary rapid testing to provide basic data for emergency situations; the invasive method ensures the accuracy of blood pressure measurement under special and complex conditions. The two methods complement each other and comprehensively improve the effectiveness and comprehensiveness of blood pressure assessment of critically ill patients.

[0022] Furthermore, the arterial puncture assembly includes an arterial puncture needle, the pressure detection assembly includes a pressure sensor, the pressure sensor is arranged at the needle tip of the arterial puncture needle, and the pressure sensor is configured to detect a first pressure value based on arterial blood flow.

[0023] In this embodiment, the pressure sensor is arranged at the needle tip of the arterial puncture needle, so that the sensor can be in direct and close contact with the arterial blood flow. Based on the direct detection of pressure by arterial blood flow, the pressure sensor can instantly capture the dynamic changes of arterial blood pressure with heart beats, and present the patient's blood pressure fluctuations in real time. Whether it is the changes in systolic and diastolic blood pressure, or the instantaneous fluctuations in blood pressure, they can be keenly perceived. For critically ill patients whose conditions change rapidly, medical staff can grasp the real-time status of the patient's blood pressure in a timely manner, and detect abnormal fluctuations in blood pressure in a timely manner, so as to quickly take corresponding medical measures.

[0024] Furthermore, the arterial puncture needle includes a double-lumen needle body structure, an intelligent hemostatic valve, and a puncture limiter. The double-lumen needle body structure is provided with a first cavity and a second cavity. A guide wire for guiding the arterial puncture needle into the artery is inserted into the first cavity, and a pressure sensor is arranged in the second cavity. The inner diameter of the first cavity is larger than that of the second cavity; the intelligent hemostatic valve is used to prevent blood from entering the first cavity; the puncture limiter is used to limit the maximum puncture depth of the arterial puncture needle.

[0025] The arterial puncture needle is made of medical-grade stainless steel material to ensure its strength and biocompatibility. The inner diameter of the first cavity is designed to be 2 mm, and the inner diameter of the second cavity is 1 mm. In actual operation, the guide wire is inserted through the first cavity to guide the arterial puncture needle to accurately enter the artery. The diameter of the guide wire is 1.5 mm, and its front end has a soft elastic tip to reduce damage to the inner wall of the blood vessel.

[0026] The intelligent hemostatic valve is installed at a position near the needle tail of the first cavity. The intelligent hemostatic valve adopts an intelligent control mechanism based on pressure sensing. When the arterial puncture needle is not inserted into the artery, the intelligent hemostatic valve is in a closed state. When the arterial puncture needle successfully enters the artery, the blood pressure will trigger the pressure sensor in the intelligent hemostatic valve, causing the intelligent hemostatic valve to open and allowing the guide wire to pass through. After the guide wire is withdrawn, the intelligent hemostatic valve will automatically close again to prevent blood from flowing out, effectively avoiding the risks of blood leakage and infection.

[0027] The puncture limiter is configured as an adjustable plastic part and is connected to the needle body of the arterial puncture needle by threads. Medical staff can rotate the puncture limiter according to the specific situation of the patient, such as the depth of the blood vessel, to adjust the distance between it and the needle tip, thereby limiting the maximum puncture depth of the arterial puncture needle. For example, for pediatric patients or patients with relatively shallow blood vessels, the puncture limiter can be adjusted to a position 1-2 cm away from the needle tip; for adult patients with relatively deep blood vessels, the distance can be appropriately increased to 3-4 cm.

[0028] In this embodiment, the guide wire threaded through the first cavity plays a key guiding role during the puncture process. It has a diameter of 1.5 mm and a soft elastic tip at the front end. When inserted into the artery, it can effectively reduce the risk of scratching and damaging the inner wall of the blood vessel. Especially for patients with relatively fragile blood vessels, such as the elderly, children, or patients with vascular diseases, the guidance of the guide wire can ensure that the arterial puncture needle accurately enters the artery, reduce the vascular trauma caused by repeated punctures, improve the puncture success rate, and ensure the smooth progress of subsequent pressure detection. A pressure sensor is arranged in the second cavity, and the inner diameter of the first cavity is larger than that of the second cavity. This layout provides a stable and suitable installation environment for the pressure sensor. On the one hand, it can prevent the pressure sensor from being damaged by excessive external force during the puncture process; on the other hand, the second cavity can provide a certain protection for the pressure sensor, enabling it to focus on sensing the changes in arterial blood flow pressure, ensuring the accuracy of pressure detection, providing a hardware guarantee for obtaining accurate first pressure values, and laying a foundation for accurately judging the patient's blood pressure condition clinically. The intelligent hemostatic valve is based on a pressure-sensing intelligent control mechanism. When the arterial puncture needle is not inserted into the artery, the hemostatic valve is closed, which can effectively prevent external bacteria and other contaminants from entering the first cavity and avoid potential infection risks. When the puncture needle successfully enters the artery, the blood pressure triggers the hemostatic valve to open, allowing the guide wire to pass through; it automatically closes after the guide wire is withdrawn, preventing blood from flowing out. It greatly reduces the situation of blood leakage and reduces the possibility of infection caused by blood exposure, improving the safety during the invasive blood pressure measurement process. The puncture limiter is threadedly connected to the body of the arterial puncture needle. Medical staff can flexibly adjust its distance from the needle tip according to individual differences such as the patient's blood vessel depth, improving the applicability of the arterial puncture needle in different patient groups and enhancing the safety and effectiveness of the invasive blood pressure measurement operation.

[0029] Furthermore, the invasive blood pressure sensing device further includes a self-adhesive fixing patch, which is fixedly connected to the arterial puncture needle. The self-adhesive fixing patch is configured to fix the arterial puncture needle at the arterial body surface position when the invasive blood pressure sensing device is working. The self-adhesive fixing patch is made of a medical-grade breathable, waterproof and highly adhesive silicone material. On the adhesive surface of the self-adhesive fixing patch, a layer of hypoallergenic adhesive is pre-coated to ensure that it can firmly adhere to the patient's skin during long-term use without causing discomfort symptoms such as skin allergies in the patient. The edge of the self-adhesive fixing patch is designed in a wavy shape, increasing the contact area between the fixing patch and the skin and further improving the fixing stability. When the invasive blood pressure sensing device is working, medical staff first paste the fixing patch around the puncture point on the patient's arterial body surface, and then insert the arterial puncture needle into the artery through the small hole of the fixing patch, so that the arterial puncture needle is firmly fixed together with the fixing patch to prevent the puncture needle from shifting when the patient moves.

[0030] In this embodiment, the self - adhesive fixing patch can firmly fix the arterial puncture needle at the arterial body surface position when the invasive blood pressure sensing device is working, effectively avoiding the situation where the puncture needle is displaced due to the patient's movement. In the actual clinical scenario, it is often difficult for patients to remain absolutely still during intensive care. The displacement of the puncture needle may lead to inaccurate measurement and even damage to blood vessels. The fixing patch can ensure that the puncture needle is always in the correct position, maintaining the continuity and accuracy of blood pressure measurement. The medical - grade breathable, waterproof and highly adhesive silicone material is selected, which not only ensures the function of the fixing patch but also takes into account the patient's comfort. The breathable performance can prevent the skin from feeling stuffy and sweating due to long - term covering, reducing discomfort. The waterproof property can avoid water infiltration during daily care operations such as body wiping, which may affect the fixing effect or cause infection. At the same time, the hypoallergenic adhesive pre - coated on the adhesive surface can greatly reduce the risk of skin allergy in patients. For patients with relatively sensitive skin, this design is particularly crucial and can significantly improve the patient's tolerance during the use of the invasive blood pressure sensing device. The edge of the self - adhesive fixing patch adopts a wavy design, which greatly increases the contact area with the skin. Compared with the ordinary flat edge, the wavy edge can better adapt to the subtle undulations of the human skin surface, making the fixing patch fit more closely with the skin. When the skin tension changes due to the patient's body movement, the wavy edge can disperse the stress through its own deformation, maintaining the fixing effect, further improving the fixing stability of the arterial puncture needle and ensuring the reliability of the invasive blood pressure measurement process.

[0031] Furthermore, a high - precision micro - piezoresistive pressure sensor is selected as the pressure sensor, which can accurately detect the pressure changes generated by arterial blood flow. The micro - piezoresistive pressure sensor is tightly installed at the tip of the arterial puncture needle. Through a special sealing process, it is ensured that the pressure sensor can accurately sense the pressure in the artery without being damaged by blood erosion. A flexible conductive circuit is used to connect the micro - piezoresistive pressure sensor and the arterial puncture needle. The flexible conductive circuit has good flexibility and anti - tensile performance and will not affect the normal operation of the arterial puncture needle. At the same time, the conductive circuit is coated with an insulating and waterproof material to prevent faults such as short - circuits during use.

[0032] In this embodiment, a high-precision micro piezoresistive pressure sensor is selected, which can accurately capture the subtle pressure changes generated by arterial blood flow. The pressure sensor is tightly installed at the tip of the arterial puncture needle, minimizing the pressure conduction path and reducing the loss and interference during signal transmission, ensuring that the pressure sensor can quickly and directly sense the pressure in the artery. The good flexibility and tensile resistance of the flexible conductive circuit ensure that during the arterial puncture process, the circuit will not be damaged due to operations such as the movement and bending of the puncture needle, nor will it impede the normal use of the puncture needle, guaranteeing the smoothness and accuracy of the puncture operation. At the same time, the outer coating of insulating and waterproof materials further enhances the reliability of the circuit, effectively preventing short-circuit faults in a humid clinical environment or due to blood contact, etc., ensuring the stability and accuracy of signal transmission between the pressure sensor and the host processing unit, and ensuring that blood pressure data can be transmitted in a timely and accurate manner.

[0033] Furthermore, the non-invasive blood pressure sensing device includes an adaptive wristband and a sensor array. The adaptive wristband has an inner side and an outer side that are oppositely arranged. When the adaptive wristband is worn at the arterial body surface position, it contacts the body surface position of the limb artery through the inner side, and the sensor array is arranged on the inner side of the adaptive wristband to detect the second pressure value.

[0034] Specifically, the adaptive wristband is made of adjustable elastic materials, such as a composite material of silicone and elastic fiber, to adapt to the thickness of the limbs of different patients. The length of the wristband can be adjusted between 15 - 40 cm, and the width is 3 - 5 cm. The inner side of the wristband is made of a soft skin-friendly material such as polyurethane foam to ensure that it will not cause irritation to the patient's skin when worn. The outer side of the wristband is provided with adjustable fasteners, including Velcro or buckles, which are convenient for medical staff to adjust according to the wrist circumference of the patient, enabling the wristband to be worn tightly and comfortably at the arterial body surface position of the patient, such as the radial artery at the wrist or the brachial artery at the elbow. When the wristband is worn at the arterial body surface position, its inner side can make full contact with the body surface position of the limb artery, providing good conditions for the sensor array to accurately detect the pressure value.

[0035] In this embodiment, the adaptive wristband is made of adjustable elastic material and can be adapted to the thickness of different patients' limbs. When worn, its inner side is in full contact with the surface position of the artery of the limbs, enabling the sensor array to accurately detect the second pressure value. The good adaptability of the adaptive wristband ensures that for any patient, the sensor array can stably and effectively sense the arterial pressure fluctuations, improving the universality and reliability of blood pressure detection. The sensor array is arranged on the inner side of the adaptive wristband, enabling it to sense the pressure changes of the artery closely and directly, and can capture the details of arterial pressure fluctuations more sensitively and accurately. For example, during the detection process, the pressure signal characteristics corresponding to systolic blood pressure and diastolic blood pressure can be clearly distinguished, improving the accuracy of non-invasive blood pressure measurement and providing more valuable blood pressure data for clinical diagnosis. Further, the sensor array is provided with arranged in the way of

[0036] a plurality of piezoelectric sensing units and a Doppler blood flow probe. The pressure sensing unit is used to capture the arterial pressure fluctuation signal, and the Doppler blood flow probe is used to detect the blood flow velocity of the artery through an ultrasonic beam.

[0037] Specifically, the sensor array is provided with 16 piezoelectric sensing units arranged in a 3×3 manner and a Doppler blood flow probe. The piezoelectric sensing unit is made of piezoelectric ceramic material, and the size of each piezoelectric sensing unit is 2mm×2mm×1mm. The piezoelectric sensing unit can sensitively capture the arterial pressure fluctuation signal. When the pressure in the artery changes, the piezoelectric sensing unit will generate corresponding electrical signal changes. The Doppler blood flow probe is installed at the center position of the sensor array, and its operating frequency is 5MHz. By emitting and receiving ultrasonic beams, the Doppler blood flow probe can detect the blood flow velocity of the artery. In actual operation, the ultrasonic beam is emitted into the artery blood vessel, and the red blood cells in the blood will scatter the ultrasonic wave. According to the Doppler effect, the frequency of the reflected ultrasonic wave will change. By detecting this frequency change, the blood flow velocity of the artery can be calculated. By arranging a plurality of piezoelectric sensing units in this

[0038] arrangement mode, the arterial pressure fluctuation signal can be captured in all directions. When the arterial blood pressure changes, the piezoelectric sensing units sense the pressure changes from different positions and angles, convert the pressure signal into an electrical signal, and provide rich data dimensions for blood pressure calculation. At the same time, combined with the Doppler blood flow probe, the blood flow velocity of the artery is detected by emitting and receiving ultrasonic beams. The blood flow velocity is closely related to blood pressure, and the combination of the two enables the system to obtain more comprehensive physiological information. Further, the sensor array has multiple working modes, and the working modes at least include a first working mode, a second working mode, and a calibration mode. When the sensor array is in the first working mode, the second pressure value is detected through 2 diagonally arranged piezoelectric sensing units. When the pressure sensor is in the second working mode, through A piezoelectric sensing unit detects the second pressure value, and when the sensor array is in the calibration mode, the detected blood flow velocity by the Doppler blood flow probe is used to correct the second pressure value.

[0039] Specifically, in the first working mode, only 2 diagonally arranged piezoelectric sensing units are used to detect the second pressure value. The first working mode is suitable for a preliminary and rapid detection of blood pressure, for example, when the patient's condition is relatively stable and a rough blood pressure data is needed quickly. By the diagonally arranged piezoelectric sensing units, the pressure fluctuations of the artery can be detected from two different directions to preliminarily judge the range of blood pressure. In the second working mode, all 9 piezoelectric sensing units are used to detect the second pressure value. When a more accurate blood pressure measurement is required, switch to this mode. The 9 piezoelectric sensing units comprehensively detect the pressure fluctuations of the artery from multiple angles, and can obtain more detailed and accurate pressure signals, thereby improving the accuracy of blood pressure measurement. In the calibration mode, the detected blood flow velocity by the Doppler blood flow probe is used to correct the second pressure value. Since there is a certain correlation between blood pressure and blood flow velocity, when the blood pressure measurement is affected by external interference or a more accurate measurement result is needed, the blood flow velocity data detected by the Doppler blood flow probe is used, combined with a preset algorithm to correct the pressure value detected by the piezoelectric sensing unit to improve the accuracy of blood pressure measurement. For example, when an abnormal blood flow velocity is detected, the algorithm will adjust the pressure value according to the relationship model between blood flow velocity and blood pressure, so as to obtain a more accurate blood pressure value.

[0040] In this embodiment, the first working mode detects the second pressure value only through two diagonally arranged piezoelectric sensing units, which greatly improves the detection speed. When the patient's condition is relatively stable and only approximate blood pressure data needs to be obtained quickly, the first working mode can respond quickly, reducing the amount of data processing and giving a preliminary blood pressure range in a short time. For example, in the emergency room, when a large number of patients need to be triaged quickly, the blood pressure data obtained in the first working mode can be used to initially determine whether the patient's blood pressure is in the dangerous range, so as to determine the priority of subsequent diagnosis and treatment and gain precious time for emergency treatment. The second working mode enables all piezoelectric sensing units to detect the pressure value, comprehensively covering the pressure fluctuations of the artery. Each unit senses the pressure changes from different angles, and the collected signals are more abundant and comprehensive. For example, when treating a patient with hypertensive crisis, accurate blood pressure values can help doctors accurately adjust the dosage of antihypertensive drugs, avoid over-lowering or under-lowering of blood pressure, and ensure the treatment effect and patient safety. The correction mode corrects the second pressure value by using the blood flow velocity detected by the Doppler blood flow probe, fully considering the internal relationship between blood pressure and blood flow velocity. When external factors interfere with blood pressure measurement, such as the distortion of pressure signals caused by the movement of the patient's limb, the blood flow velocity is relatively stable and can be used as a correction basis. According to the preset algorithm, integrating the blood flow velocity data into the pressure value calculation can effectively correct the measurement deviation. For example, when the patient is in the rehabilitation training stage and the limbs are moving frequently, it can ensure that the blood pressure measurement results are close to the true value, providing reliable blood pressure information for medical staff and facilitating the evaluation of the patient's rehabilitation progress and physical condition.

[0041] Further, the host processing unit includes a signal calibration module, which is configured to eliminate the invasive catheter resonance effect generated by the invasive blood pressure sensing device or eliminate the non-invasive motion artifacts generated by the non-invasive blood pressure sensing device. Specifically, for the invasive catheter resonance effect generated by the invasive blood pressure sensing device, the signal calibration module of this embodiment adopts an algorithm based on digital filtering. When the invasive blood pressure sensing device is working, the signal calibration module collects the electrical signal output by the pressure sensor in real time. Since the invasive catheter resonance effect can cause periodic interference fluctuations in the electrical signal, the signal calibration module uses a band-stop filter to filter the electrical signal by identifying the frequency characteristics of the interference fluctuations, and removes the signal components related to the resonance frequency of the invasive catheter, thereby eliminating the influence of the invasive catheter resonance effect on blood pressure measurement. For the non-invasive motion artifacts generated by the non-invasive blood pressure sensing device, the signal calibration module adopts a method combining an acceleration sensor and adaptive filtering. A miniature acceleration sensor is integrated on the adaptive wristband to detect the movement of the patient's limbs. When the patient's limbs move, the acceleration sensor will generate corresponding electrical signal changes. The signal calibration module judges the patient's movement state based on the signal of the acceleration sensor, and uses an adaptive filtering algorithm to process the pressure signal detected by the sensor array. For example, when a large amplitude movement of the patient's limbs is detected, the adaptive filtering algorithm will adjust the parameters of the filter to enhance the suppression of motion-related interference components in the pressure signal, thereby eliminating non-invasive motion artifacts and improving the accuracy of blood pressure measurement.

[0042] In this embodiment, the resonance effect of the invasive catheter will interfere with the pressure signal collected by the invasive blood pressure sensing device, resulting in deviations in the measured data. The signal calibration module uses an algorithm based on digital filtering to capture the electrical signal output by the pressure sensor in real time. By accurately identifying the frequency characteristics of the periodic interference fluctuations generated by the resonance of the invasive catheter, the band-stop filter is used to perform targeted processing on the electrical signal to remove the interference signal components related to the resonance frequency. The invasive blood pressure measurement data is closer to the patient's actual blood pressure value, providing accurate blood pressure data support for doctors when performing critical care, such as cardiac surgery and severe shock rescue, which helps doctors accurately judge the condition, reasonably adjust the treatment plan, and ensure the safety of patients' lives. During non-invasive blood pressure monitoring, the patient's limb movement is prone to non-invasive motion artifacts, which seriously affects the accuracy of blood pressure measurement. The signal calibration module uses a micro-accelerometer integrated on the adaptive wristband to monitor the patient's limb movement in real time. When it is detected that the limb movement causes the acceleration sensor's electrical signal to change, the signal calibration module judges the patient's movement state based on these signals, and uses an adaptive filtering algorithm to optimize the pressure signal detected by the sensor array. For example, when the patient turns over, raises his hand, etc., the algorithm will automatically adjust the filter parameters to strengthen the suppression of motion-related interference components in the pressure signal and effectively eliminate non-invasive motion artifacts.

[0043] Furthermore, the host processing unit has multiple monitoring modes, and the monitoring modes at least include an invasive monitoring mode, a non-invasive monitoring mode, and a dual-mode monitoring mode. When the host processing unit is in the invasive monitoring mode, it only receives the first pressure value feedback by the invasive blood pressure sensing device. When the host processing unit is in the non-invasive monitoring mode, it only receives the second pressure value feedback by the non-invasive blood pressure sensing device. When the host processing unit is in the dual-mode monitoring mode, it receives both the first pressure value and the second pressure value simultaneously.

[0044] Specifically, when the host processing unit is in the invasive monitoring mode, the host processing unit only receives the first pressure value feedback by the invasive blood pressure sensing device. At this time, the host processing unit obtains the pressure data of the pressure sensor of the invasive blood pressure sensing device through wireless communication. Then, according to the preset blood pressure calculation algorithm, the pressure value is converted into a blood pressure value and displayed on the display screen of the host processing unit. The invasive monitoring mode is applicable to critically ill patients with extremely high requirements for blood pressure measurement accuracy. For example, during a cardiac operation, doctors can understand the blood pressure changes of patients in real time and accurately through the invasive monitoring mode. When the host processing unit is in the non-invasive monitoring mode, the host processing unit only receives the second pressure value feedback by the non-invasive blood pressure sensing device. The host processing unit communicates with the sensor array of the non-invasive blood pressure sensing device to obtain the data detected by the piezoelectric sensing unit and the Doppler blood flow probe. According to different working modes, these data are processed and calculated accordingly to obtain the blood pressure value and display it. The non-invasive monitoring mode is applicable to situations where the patient's condition is relatively stable and long-term and continuous blood pressure monitoring is required. The non-invasive monitoring causes less trauma to the patient and is more acceptable to the patient. When the host processing unit is in the dual-mode monitoring mode, the host processing unit receives both the first pressure value and the second pressure value simultaneously. At this time, the host processing unit comprehensively analyzes the data obtained by the invasive blood pressure sensing device and the non-invasive blood pressure sensing device. Through the data fusion module, a blood pressure dynamic association model is created according to the first pressure value and the second pressure value.

[0045] In this embodiment, the invasive monitoring mode is applicable to critically ill patients with extremely high requirements for blood pressure measurement accuracy, such as in cases of cardiac surgery, severe traumatic shock, etc. In this mode, the host processing unit only receives the first pressure value feedback by the invasive blood pressure sensing device. Since invasive measurement can directly obtain the arterial pressure, excluding the interference of peripheral factors, the data accuracy is high. Doctors can thereby accurately and in real time grasp the patient's blood pressure changes, providing a reliable basis for finely adjusting treatment plans, such as the dosage of cardiovascular active drugs, cardiac surgery operations, etc., and greatly ensuring the patient's life safety. The non-invasive monitoring mode is mainly used in scenarios where the patient's condition is relatively stable and long-term and continuous blood pressure monitoring is required. The host processing unit only receives the second pressure value feedback by the non-invasive blood pressure sensing device. Because the non-invasive method causes minimal trauma to the patient and the patient has good tolerance, it can be worn for a long time for monitoring. In situations such as the rehabilitation period of chronic disease patients and partial mild case monitoring, medical staff can continuously obtain the patient's blood pressure data through this mode, understand the development trend of the condition, timely discover potential problems, and will not bring additional pain and infection risks to the patient.

[0046] Further, the host processing unit includes a data fusion module, and the data fusion module is configured to create a blood pressure dynamic association model according to the first pressure value and the second pressure value when the host processing unit is in the dual-mode monitoring mode, and output a third pressure value according to the blood pressure dynamic association model.

[0047] The data fusion module of this embodiment uses an algorithm based on machine learning to create a blood pressure dynamic association model. In the dual-mode monitoring mode, the data fusion module collects a large amount of data of the first pressure value of the invasive blood pressure sensing device and the second pressure value of the non-invasive blood pressure sensing device, and combines other physiological parameters of the patient, such as heart rate, blood oxygen saturation, etc. Using these data, a neural network model is trained, and the neural network model can learn the dynamic relationship between invasive blood pressure and non-invasive blood pressure. For example, through the training of a large amount of data, the neural network model finds that when the invasive blood pressure increases, the pressure fluctuation signal and blood flow velocity of the non-invasive blood pressure will also show specific change trends. When the host processing unit is in the dual-mode monitoring mode, the data fusion module inputs the real-time received first pressure value and second pressure value into the trained neural network model, and the model outputs a third pressure value according to the learned dynamic relationship. This third pressure value synthesizes the information of both invasive and non-invasive measurement methods, and can more accurately reflect the patient's true blood pressure situation compared with single invasive or non-invasive blood pressure measurement, providing a more reliable basis for doctors to diagnose and treat the condition of critically ill patients.

[0048] In this embodiment, in the dual-modal monitoring mode, the data fusion module integrates the first pressure value and the second pressure value, and the created blood pressure dynamic correlation model can integrate multi-dimensional data. Compared with a single measurement method, it can effectively make up for their respective limitations. For example, invasive measurements may be interfered by catheter factors, and non-invasive measurements are easily affected by limb movements. After fusion, they can correct each other, and the output third pressure value is closer to the patient's actual blood pressure, providing doctors with more reliable data support for diagnosing the disease and adjusting the treatment plan, and playing a key role in complex disease judgment and precise medication dosage adjustment.

[0049] Beneficial effects of this embodiment: The non-invasive blood pressure sensing device, as a wearable flexible sensing module, does not need to wrap a cuff, and can quickly sense the non-invasive blood pressure of the limbs. In emergency situations, such as when a patient with traumatic shock is sent to the hospital, the basal blood pressure can be obtained in the first time, which buys precious time for clinical diagnosis and treatment. The invasive blood pressure sensing device sets the pressure sensor at the tip of the arterial puncture needle, closely contacts the arterial blood flow, accurately detects the first pressure value, and presents the blood pressure fluctuation in real time. For shock patients using vasoactive drugs, the problem of peripheral non-invasive blood pressure measurement distortion can be overcome. The various working modes of the sensor array can be adjusted according to needs. For example, in complex conditions, the correction mode uses the blood flow velocity detected by the Doppler blood flow probe to correct the pressure value and improve the measurement accuracy. The signal calibration module of the host processing unit can effectively eliminate the resonance effect of the invasive catheter and the non-invasive motion artifact to ensure data reliability. A variety of monitoring modes can meet different stages of the disease. The invasive monitoring mode is suitable for critical illnesses that require extremely high precision, such as providing doctors with accurate blood pressure data to adjust treatment plans during heart surgery; the non-invasive monitoring mode is used for long-term continuous monitoring during the stable period of the disease, which causes less trauma to the patient; in the dual-modal monitoring mode, the data fusion module creates a blood pressure dynamic correlation model, and the output third pressure value integrates invasive and non-invasive measurement information to more realistically reflect the patient's blood pressure, provide a strong basis for the diagnosis and treatment of complex diseases, and comprehensively improve the effectiveness and comprehensiveness of blood pressure assessment for critically ill patients.

[0050] The above specific implementation is a preferred implementation of the present invention having a dual-modal blood pressure assessment system for critically ill patients, and is not intended to limit the specific implementation scope of the present invention. The scope of the present invention includes but is not limited to this specific implementation. All equivalent changes made in accordance with the shape and structure of the present invention are within the protection scope of the present invention.

Claims

1. A dual-modal blood pressure assessment system for critically ill patients, characterized in that, Comprising: An invasive blood pressure sensing device, the invasive blood pressure sensing device includes an arterial puncture assembly and a pressure detection assembly, the pressure detection assembly is connected to the arterial puncture assembly, and the invasive blood pressure sensing device is configured to detect a first pressure value through the pressure detection assembly after being inserted into an artery through the arterial puncture assembly; A non-invasive blood pressure sensing device, the non-invasive blood pressure sensing device is configured as a flexible sensing module wearable at the surface position of an artery for detecting a second pressure value; A host processing unit, the host processing unit is respectively signal-connected to the invasive blood pressure sensing device and the non-invasive blood pressure sensing device, and the host processing unit is used to receive the first pressure value or the second pressure value and calculate the blood pressure value.

2. The dual-modal blood pressure assessment system for critically ill patients according to claim 1, characterized in that, The arterial puncture assembly includes an arterial puncture needle, the pressure detection assembly includes a pressure sensor, the pressure sensor is arranged at the tip of the arterial puncture needle, and the pressure sensor is configured to detect the first pressure value based on arterial blood flow.

3. The dual-modal blood pressure assessment system for critically ill patients according to claim 2, characterized in that, The arterial puncture needle includes a double-lumen needle body structure, an intelligent hemostatic valve and a puncture limiter. The double-lumen needle body structure is provided with a first cavity and a second cavity. A guide wire for guiding the arterial puncture needle into the artery is inserted into the first cavity, and the pressure sensor is arranged in the second cavity. The inner diameter of the first cavity is larger than that of the second cavity; the intelligent hemostatic valve is used to prevent blood from entering the first cavity; the puncture limiter is used to limit the maximum puncture depth of the arterial puncture needle.

4. A dual-modal blood pressure assessment system for critically ill patients according to claim 2, characterized in that, The invasive blood pressure sensing device further includes a self-adhesive fixing patch, the self-adhesive fixing patch is fixedly connected to the arterial puncture needle, and the self-adhesive fixing patch is configured to fix the arterial puncture needle at the surface position of the artery when the invasive blood pressure sensing device is working.

5. The dual-modal blood pressure assessment system for critically ill patients according to claim 1, characterized in that, The non-invasive blood pressure sensing device includes an adaptive wristband and a sensor array. The adaptive wristband has an inner side and an outer side arranged oppositely. When the adaptive wristband is worn at the surface position of the artery, it contacts the surface position of the limb artery through the inner side, and the sensor array is arranged on the inner side of the adaptive wristband to detect the second pressure value.

6. The dual-modal blood pressure assessment system for critically ill patients according to claim 5, characterized in that The sensor array is provided with arranged in a manner, and a Doppler blood flow probe. The pressure sensing unit is used to capture the pressure fluctuation signal of the artery, and the Doppler blood flow probe is used to detect the blood flow velocity of the artery through an ultrasonic beam.

7. The dual-modal blood pressure assessment system for critically ill patients according to claim 6, wherein The sensor array has multiple operating modes, and the operating modes at least include a first operating mode, a second operating mode, and a calibration mode. When the sensor array is in the first operating mode, the second pressure value is detected by two diagonally arranged piezoelectric sensing units. When the pressure sensor is in the second operating mode, the second pressure value is detected by piezoelectric sensing units, and when the sensor array is in the calibration mode, the second pressure value is corrected by the blood flow velocity detected by the Doppler blood flow probe.

8. A dual-modal blood pressure assessment system for critically ill patients according to claim 1, characterized in that, The host processing unit includes a signal calibration module, and the signal calibration module is configured to eliminate the invasive catheter resonance effect generated by the invasive blood pressure sensing device or eliminate the non-invasive motion artifact generated by the non-invasive blood pressure sensing device.

9. The dual-modal blood pressure assessment system for critically ill patients according to claim 1, wherein The host processing unit has multiple monitoring modes, and the monitoring modes at least include an invasive monitoring mode, a non-invasive monitoring mode and a dual-mode monitoring mode. When the host processing unit is in the invasive monitoring mode, it only receives the first pressure value feedback by the invasive blood pressure sensing device. When the host processing unit is in the non-invasive monitoring mode, it only receives the second pressure value feedback by the non-invasive blood pressure sensing device. When the host processing unit is in the dual-mode monitoring mode, it simultaneously receives the first pressure value and the second pressure value.

10. A dual-modal blood pressure assessment system for critically ill patients according to claim 9, characterized in that, The host processing unit includes a data fusion module, and the data fusion module is configured to create a blood pressure dynamic association model according to the first pressure value and the second pressure value when the host processing unit is in the dual-mode monitoring mode, and output a third pressure value according to the blood pressure dynamic association model.

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