Disposable intracardiac hemodynamic parameter monitoring catheter

By designing a disposable intracardiac hemodynamic parameter monitoring catheter integrated with multiple sensors, combined with Kalman filtering and weighted smoothing algorithms, the discomfort and high cost problems of existing monitoring methods are solved, and safe and efficient hemodynamic parameter monitoring is achieved, which is suitable for a variety of clinical applications.

CN120392052APending Publication Date: 2025-08-01NAN JING DAO YI SHENG WU YI XUE KE JI YOU XIAN GONG SI
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Patent Information

Application Number
CN202510272785.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-03-10
Publication Date
2025-08-01

AI Technical Summary

Technical Problem

The existing intracardiac hemodynamic parameter monitoring methods have problems such as discomfort, high risk of complications, expensive equipment and complex operation, especially thermal dilution and esophageal ultrasound methods have limitations and high costs in clinical applications.

Method used

A disposable hemodynamic parameter monitoring catheter in the heart cavity is designed, integrating temperature sensors, floating guide airbags, PAOP pressure transducers, blocking pressure airbags, CVP transducers and other sensors. The data processing is performed using anti-divergent Kalman filtering method and weighted smoothing algorithm. The structure is small and simple to operate, and can display hemodynamic parameters in real time.

Benefits of technology

It realizes low-cost, safe and efficient monitoring of hemodynamic parameters, reduces complication risks, simplifies operating procedures, is suitable for a variety of clinical scenarios, and reduces the cost of medical use.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention discloses a disposable intracardiac hemodynamic parameter monitoring catheter which is provided with a catheter body. A temperature sensor, a floating guide air bag, a PAOP pressure transducer, a blocking pressure air bag, a CVP transducer, a floating guide air bag injection port, a blocking pressure air bag injection port and an external equipment transmission interface are sequentially arranged from the front end to the rear end of the catheter main body, an oxygen saturation SPO2 sensor conduction optical fiber is installed in the catheter main body, and a graduated scale is arranged outside the catheter main body; according to the monitoring system of the disposable monitoring catheter for the hemodynamic parameters in the cardiac cavity, filtering is conducted on the cardiac cavity pressure measured by the catheter through an anti-divergence Kalman filtering method, then further processing is conducted through a weighted smoothing algorithm, and the hemodynamic parameters such as the pressure monitored in the cardiac cavity and the blood oxygen saturation degree can be accurately and dynamically displayed in real time; and through reasonable design, the monitoring catheter is novel and small in structure, simple in using method, safe and efficient.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical monitoring instruments and equipment, and particularly relates to a disposable intracardiac hemodynamic parameter monitoring catheter. Background Art

[0002] Intracardiac hemodynamic parameter monitoring plays an irreplaceable role in clinical diagnosis, treatment, rehabilitation and critical care management, and is an important tool indispensable to modern medicine; intracardiac hemodynamic parameters are important indicators for evaluating cardiac function. By monitoring these parameters, the pumping ability and circulation status of the heart can be comprehensively understood, so as to more accurately judge whether the patient has cardiac insufficiency. Monitoring of hemodynamic parameters can provide an important basis for clinical treatment. Accurately evaluating the volume status of the patient is the key to clinical treatment and helps doctors diagnose the cause more accurately; through invasive or non-invasive monitoring means, information such as the patient's volume status, preload, afterload and myocardial contractility can be determined. In addition, during the perioperative period, hemodynamic monitoring helps to optimize the patient's volume management and reduce postoperative complications.

[0003] At present, there are two commonly used methods for intracardiac hemodynamic parameter monitoring in clinical practice. One is the esophageal ultrasound method, but it needs to be inserted into the human body through the esophagus, which causes considerable discomfort after the patient's anesthesia recovery, and it cannot be used in the case of esophageal complications. There are many clinical limitations; the other commonly used method is the thermodilution method. It is to insert a balloon catheter into the venous system through the vein, and finally reach the pulmonary artery through the right atrium and right ventricle. The pulmonary artery pressure can be continuously measured during the patient's anesthesia, and the balloon at the end of the catheter can be inflated, float with the blood flow and wedge into the distal pulmonary arteriole to block the blood flow, and measure the pulmonary capillary wedge pressure. At present, conventional balloon catheters can measure a variety of hemodynamic indicators, but while monitoring the function of intracardiac hemodynamic parameters, a large number of external devices are needed to assist it to complete the corresponding data monitoring, and some monitoring needs to be completed by experienced doctors. At present, most of such monitoring devices and consumables are imported, with high prices and extremely high clinical use costs, extremely inconvenient to use, and improper operation can also cause serious complications or even death; for this reason, the applicant proposes a disposable intracardiac hemodynamic parameter monitoring catheter according to the monitoring requirements of intracardiac hemodynamic parameters. Through reasonable design, its structure is novel and compact, the usage method is simple, and it is safe and efficient. Summary of the Invention

[0004] To solve the above problems, the present invention discloses a disposable intracardiac hemodynamic parameter monitoring catheter. The monitoring catheter is provided with a catheter body, and a temperature sensor, a floating guiding balloon, a PAOP pressure transducer, an occlusion pressure balloon, a CVP transducer, a floating guiding balloon injection port, an occlusion pressure balloon injection port, and an external device transmission interface are sequentially arranged from the front end to the rear end of the catheter body. An oxygen saturation SPO2 sensor conduction optical fiber is installed inside the catheter body, and a scale is arranged outside. The monitoring system of the disposable intracardiac hemodynamic parameter monitoring catheter uses an anti-divergent Kalman filtering method to filter the intracardiac pressure measured by the catheter, and then further processes it using a weighted smoothing algorithm, which can accurately display the hemodynamic parameters such as the pressure and blood oxygen saturation monitored in the heart cavity in real time dynamically, facilitating doctors' clinical treatment and medication. Through reasonable design, the monitoring catheter has a novel and compact structure, a simple usage method, and is safe and efficient.

[0005] To achieve the above object, the technical solution of the present invention is as follows:

[0006] A disposable intracardiac hemodynamic parameter monitoring catheter, comprising a catheter body, a CVP pressure transducer, an occlusion pressure balloon, a PAOP pressure transducer, a floating guiding balloon, an oxygen saturation SPO2 sensor conduction optical fiber, a temperature sensor, and a scale, an external device transmission interface, an occlusion pressure balloon injection port, and a floating guiding balloon injection port. It is characterized in that the disposable intracardiac hemodynamic parameter monitoring catheter is provided with a catheter body. A temperature sensor is arranged at the front end of the catheter body (1), a floating guiding balloon is arranged at the rear end of the temperature sensor, a PAOP pressure transducer is arranged at the rear end of the floating guiding balloon, an occlusion pressure balloon is arranged at the rear end of the PAOP pressure transducer, a CVP transducer is arranged at the rear end of the occlusion pressure balloon, an occlusion pressure balloon injection port and a floating guiding balloon injection port are arranged at the rear end of the CVP transducer, an external device transmission interface is arranged at the tail end of the catheter body, an oxygen saturation SPO2 sensor conduction optical fiber is installed inside the catheter body, and a scale is arranged outside the catheter body. Wires communicating the temperature sensor, the PAOP pressure transducer, and the CVP transducer are further arranged inside the catheter body, a catheter communicating the floating guiding balloon with the floating guiding balloon injection port, and a catheter communicating the occlusion pressure balloon with the occlusion pressure balloon injection port; the CVP transducer, the PAOP pressure transducer, the oxygen saturation SPO2 sensor conduction optical fiber, and the temperature sensor are connected to an external device through the external device transmission interface.

[0007] Furthermore, the temperature sensor provided in the disposable intracardiac hemodynamic parameter monitoring catheter is arranged at a position 10 mm - 15 mm away from the front end of the catheter body, and the CVP transducer is arranged at a position 280 mm - 400 mm away from the front end of the catheter body.

[0008] Furthermore, the catheter body of the disposable intracardiac hemodynamic parameter monitoring catheter is made of high-density polyethylene, and the diameter of the catheter body is 2.3 mm-3 mm.

[0009] Furthermore, the occlusion pressure balloon provided in the disposable intracardiac hemodynamic parameter monitoring catheter is a tubular object, which is provided 70mm-100mm away from the front end of the catheter body. Its diameter in the uninflated state is 2.3mm-3mm, and its diameter after inflation is 13mm-15mm, and its volume is 1.5ml-1.8ml.

[0010] Furthermore, the PAOP pressure transducer provided in the disposable intracardiac hemodynamic parameter monitoring catheter is a tubular object with a diameter of 2.3 mm to 3 mm, and is provided at a distance of 50 mm to 70 mm from the front end of the catheter body.

[0011] Furthermore, the floating guide balloon provided in the disposable intracardiac hemodynamic parameter monitoring catheter is a tubular object, which is provided 20mm-40mm away from the front end of the catheter body. The diameter in the uninflated state is 2.3mm-3mm, and the diameter after inflation is 10mm-12mm, and the volume is 1.3ml-1.5ml.

[0012] Furthermore, the monitoring system of the disposable intracardiac hemodynamic parameter monitoring catheter uses an anti-divergence Kalman filtering method to filter the intracardiac pressure and aortic pressure collected by the catheter, and the specific steps are:

[0013] Step 1: Estimate the current pressure value based on the k-1th collected pressure value. The formula is:

[0014] X(k|k-1)=AX(k-1)

[0015] Where: X(k-1) is the blood pressure estimate of the k-1th sampling point;

[0016] X(k|k-1) represents the k-th blood pressure estimate obtained based on X(k-1);

[0017] A is the state transfer matrix;

[0018] Step 2: Introduce the anti-divergence factor and estimate the covariance of the current state based on the state value at the previous moment. The formula is:

[0019] P(k|k-1)=ζ(k)AP(k-1)A T +Q

[0020] Where: P is the state covariance matrix;

[0021] P(k-1) represents the state covariance matrix corresponding to the k-1th sampling point;

[0022] P(k|k - 1) represents the estimation of the k-th state covariance matrix obtained based on P(k - 1);

[0023] Q represents the process noise covariance matrix;

[0024] ζ(k) is the anti-divergence factor, and its expression is:

[0025]

[0026] Where: matrix N k , M k The specific expressions are:

[0027]

[0028] Where: β represents the weakening factor;

[0029] V0(k) represents the covariance matrix of the residuals;

[0030] R represents the observation noise covariance matrix;

[0031] H represents the observation matrix;

[0032] β takes 1.2;

[0033] The specific expression of V0(k) is:

[0034]

[0035] Where: ρ represents the forgetting factor, and the parameter is 0.98;

[0036] Step 3: Update the iterative parameters, where the updated parameters include the covariance matrix of the residuals, the Kalman filter

[0037] gain, the state value and state covariance matrix at the current stage; specifically:

[0038]

[0039] Where: Z(k) is the measured value of the k-th blood pressure;

[0040] K(k) represents the Kalman filter gain.

[0041] Furthermore, the process of smoothing the filtered pressure value using the weighted smoothing algorithm in the monitoring system of the disposable intracardiac hemodynamic parameter monitoring catheter can be expressed as:

[0042]

[0043] Where: f kIt represents the blood pressure value of the k-th sampling point after filtering processing;

[0044] w i represents f k+i corresponding weighting coefficient;

[0045] The value of m is selected as -2

[0046] The value of n is selected as 2.

[0047] The beneficial effects of the present invention are as follows:

[0048] 1. The present invention adopts a reasonable design, with a novel and compact structure, low production cost, few external devices, simple usage method, and is safe and efficient;

[0049] 2. The monitoring system of the present invention uses an anti-divergent Kalman filtering method for filtering, and then uses a weighted smoothing algorithm for further processing, which can accurately display the hemodynamic parameters such as the pressure and blood oxygen saturation monitored in the heart cavity in real time and dynamically, facilitating clinical treatment and medication by doctors.

[0050] 3. The present invention adopts an independently developed design, has good compatibility, can be compatible with some existing external devices, has a low cost for clinical medicine use, and has a wide application prospect. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Figure 1 is a schematic diagram of the partial structure of the present invention Figure I ;

[0052] Figure 2 is a schematic diagram of the partial structure of the present invention Figure II ;

[0053] Figure 3 is a schematic flow chart of the usage method of the present invention;

[0054] Figure 4 is a flow chart of the anti-divergent Kalman filtering algorithm adopted by the present invention;

[0055] Figure 5 is a flow chart of the acquisition parameters and algorithm processing display of the present invention.

[0056] LIST OF DRAWING REFERENCES:

[0057] 1. Catheter body; 2. CVP pressure transducer; 3. Occlusion pressure balloon; 4. PAOP pressure transducer; 5. Floating guiding balloon; 6. Oxygen saturation SPO2 sensor conduction optical fiber; 7. Temperature sensor; 8. Scale; 9. External device transmission interface; 10. Occlusion pressure balloon injection port; 11. Floating guiding balloon injection port. DETAILED DESCRIPTION OF THE INVENTION

[0058] The present invention will be further illustrated below in conjunction with the accompanying drawings and specific embodiments. It should be understood that the following specific embodiments are only used to illustrate the present invention and not to limit the scope of the present invention.

[0059] As Figure 1-2 shown, a disposable intracardiac hemodynamic parameter monitoring catheter includes a catheter body 1, a CVP pressure transducer 2, an occlusion pressure balloon 3, a PAOP pressure transducer 4, a floating guiding balloon 5, an oxygen saturation SPO2 sensor conducting optical fiber 6, a temperature sensor 7, and a scale 8, an external device transmission interface 9, an occlusion pressure balloon injection port 10, and a floating guiding balloon injection port 11. As Figure 1 shown, the disposable intracardiac hemodynamic parameter monitoring catheter is provided with a catheter body 1. The catheter body 1 is made of high-density polyethylene, with a diameter of 2.3 mm - 3 mm, and has the characteristics of safety, non-toxicity, and good softness. The front end of the catheter body 1 is provided with a temperature sensor 7, which is arranged at a position 10 mm - 15 mm away from the front end of the catheter body 1. The floating guiding balloon 5 is arranged at the rear end of the temperature sensor 7. The floating guiding balloon 5 is a tubular object, arranged at a position 20 mm - 40 mm away from the front end of the catheter body 1. The diameter in the non-inflated state is 2.3 mm - 3 mm, and the diameter after inflation is 10 mm - 12 mm, with a volume of 1.3 ml - 1.5 ml. The PAOP pressure transducer 4 is arranged at the rear end of the floating guiding balloon 5. The PAOP pressure transducer 4 is a tubular object, with a diameter of 2.3 mm - 3 mm, and is arranged at a position 50 mm - 70 mm away from the front end of the catheter body 1. The CVP pressure transducer 2 is arranged at a position 280 mm - 400 mm away from the front end of the catheter body 1. The occlusion pressure balloon 3 is arranged at the rear end of the PAOP pressure transducer 4. The occlusion pressure balloon 3 is a tubular object, arranged at a position 70 mm - 100 mm away from the front end of the catheter body 1. The diameter in the non-inflated state is 2.3 mm - 3 mm, and the diameter after inflation is 13 mm - 15 mm, with a volume of 1.5 ml - 1.8 ml. The CVP pressure transducer 2 is arranged at the rear end of the occlusion pressure balloon 3. The occlusion pressure balloon injection port 10 and the floating guiding balloon injection port 11 are arranged at the rear end of the CVP pressure transducer 2. The external device transmission interface 9 is arranged at the tail end of the catheter body 1. The oxygen saturation SPO2 sensor conducting optical fiber 6 is installed inside the catheter body 1, and the scale 8 is arranged outside the catheter body 1. Wires connecting the temperature sensor 7, the PAOP pressure transducer 4, and the CVP pressure transducer 2 are also arranged inside the catheter body 1. A catheter connecting the floating guiding balloon 5 and the floating guiding balloon injection port 11, and a catheter connecting the occlusion pressure balloon 3 and the occlusion pressure balloon injection port 10 are provided. The CVP pressure transducer 2, the PAOP pressure transducer 4, the oxygen saturation SPO2 sensor conducting optical fiber 6, and the temperature sensor 7 are connected to external devices through the external device transmission interface 9.

[0060] As shown in Figure 3, the following is the method of using a disposable intracardiac hemodynamic parameter monitoring catheter:

[0061] Step 1: After disinfection, make an incision in the jugular vein;

[0062] Step 2: Insert the monitoring catheter into the human body through the incision made in Step 1. At this time, the floating guiding balloon and the occlusion pressure balloon are not inflated;

[0063] Step 3: Inject CO2 gas into the floating guiding balloon through the injection port of the floating guiding balloon of the monitoring catheter; the diameter of the balloon is 2.3 mm - 3 mm in the non-inflated state, and after inflation, the diameter is 10 mm - 12 mm, and the volume is 1.3 ml - 1.5 ml;

[0064] Step 4: The PAOP pressure transducer is located in the aorta to measure the aortic pressure value;

[0065] Step 5: During the contraction of the right atrium, the balloon floats into the aorta along with the blood flow. The doctor detects the pressure change through an external device connected to the signal transmission interface;

[0066] Step 6: When the balloon moves to the end of the pulmonary artery, a regular waveform diagram will be displayed on the external device screen. At this time, it can be judged that the balloon has reached the aorta, and the gas in the balloon is released;

[0067] Step 7: Inject CO2 gas into the occlusion pressure balloon through the injection port of the occlusion pressure balloon of the monitoring catheter; the diameter of the balloon is 2.3 mm - 3 mm in the non-inflated state, and after inflation, the diameter is 13 mm - 15 mm, and the volume is 1.5 ml - 1.8 ml;

[0068] Step 8: Measure the pulmonary artery occlusion pressure value;

[0069] Step 9: Fix the monitoring catheter, and the intracardiac pressure signal, blood oxygen saturation, temperature, and aortic pressure signal can be continuously transmitted to the external device.

[0070] As Figure 4 shown, the monitoring system of the disposable intracardiac hemodynamic parameter monitoring catheter uses an anti-divergent Kalman filtering method to filter the intracardiac pressure and aortic pressure collected by the catheter. The specific steps are as follows:

[0071] Step 1: Estimate the current pressure value based on the pressure value collected at the (k - 1)th time. The formula is:

[0072] X(k|k - 1) = AX(k - 1)

[0073] where: X(k - 1) is the blood pressure estimator at the (k - 1)th sampling point;

[0074] X(k|k - 1) represents the k-th blood pressure estimator obtained based on X(k - 1);

[0075] A is the state transition matrix;

[0076] Step 2: Introduce an anti-divergence factor, and estimate the covariance of the current state based on the state value at the previous moment. The formula is:

[0077] P(k|k - 1) = ζ(k)AP(k - 1)A T +Q

[0078] Where: P is the state covariance matrix;

[0079] P(k - 1) represents the state covariance matrix corresponding to the (k - 1)-th sampling point;

[0080] P(k|k - 1) represents the estimate of the k-th state covariance matrix obtained based on P(k - 1);

[0081] Q represents the process noise covariance matrix;

[0082] ζ(k) is the anti-divergence factor, and its expression is:

[0083]

[0084] Where: matrix N k 、M k The specific expressions are:

[0085]

[0086] Where: β represents the weakening factor;

[0087] V0(k) represents the covariance matrix of the residual;

[0088] R represents the observation noise covariance matrix;

[0089] H represents the observation matrix;

[0090] β takes 1.2;

[0091] The specific expression of V0(k) is:

[0092]

[0093] Where: ρ represents the forgetting factor, and the parameter is 0.98;

[0094] Step 3: Update the iterative parameters. The updated parameters include the covariance matrix of the residual, the Kalman filter gain, the state value at the current stage, and the state covariance matrix; specifically:

[0095]

[0096] Wherein: Z(k) is the measured value of the k-th blood pressure;

[0097] K(k) represents the Kalman filter gain.

[0098] As Figure 5 shown, the process of smoothing the filtered pressure value by using the weighted smoothing algorithm in the monitoring system of the disposable intracardiac hemodynamic parameter monitoring catheter can be expressed as:

[0099]

[0100] Wherein: f k represents the blood pressure value at the k-th sampling point after filtering;

[0101] w i represents the weighting coefficient corresponding to f k+i ;

[0102] The value of m is selected as -2

[0103] The value of n is selected as 2.

[0104] The usage method of the present invention is as follows. After percutaneous puncture, the catheter enters the right atrium, right ventricle of the heart through the superior vena cava or inferior vena cava, and then enters the pulmonary artery and its branches. Combining the parameters monitored by the catheter can better judge the cardiac preload, afterload, and systolic function in real time, evaluate the cardiopulmonary function and the severity of the lesion, and is one of the relatively accurate methods for evaluating the condition and curative effect of critically ill patients; the clinical scenario indication of the present invention is the monitoring of critically ill patients and guiding clinicians to make diagnoses and treatments, including common clinical application scenarios:

[0105] 1. Anesthesia management and perioperative intensive care for patients undergoing cardiac surgery. Determine the hemodynamic status of critically ill patients, provide accurate clinical information for surgical patients in the intraoperative and postoperative intensive care unit (ICU), and the monitoring helps to evaluate the hemodynamic changes after fluid and drug treatments, maintain a satisfactory volume load, guide the use of vasoactive drugs and inotropic drugs, reduce the perioperative mortality and the incidence of major complications, shorten the ICU stay time and hospital stay, and ultimately improve the prognosis of patients;

[0106] 2. The risks brought to patients by specific surgical operations. Surgical treatment plans may lead to hemodynamic disorders and increase the risks of damage to the heart, blood vessels, kidneys, liver, lungs, or brain. Placing a catheter for monitoring during the operation may benefit patients, including high-risk and critically ill surgical patients. Such as peripheral vascular surgery, abdominal aortic surgery, neurosurgery, trauma surgery, obstetrics and gynecology surgery such as perioperative treatment of myocardial infarction during pregnancy, pulmonary hypertension, and organ transplantation surgery;

[0107] 3. Applications in ICU / CCU patients: (1) Myocardial infarction with cardiogenic shock or progressive hypotension; (2) Patients with severe sepsis and septic shock; (3) Patients with acute lung injury (ALI) / acute respiratory distress syndrome (ARDS).

[0108] 4. In terms of diagnosis: Assist in diagnosing acute right heart failure, acute left heart failure, septic shock, hemorrhagic shock, and acute pulmonary embolism.

[0109] 5. High-risk patients with ASA IV or V, at high risk of organ dysfunction or death, primary or secondary pulmonary hypertension, such as chronic pulmonary diseases, pulmonary edema, left heart failure, ARDS.

[0110] 6. Monitor cardiac function, guide the use of vasoactive drugs and evaluate the treatment effect.

[0111] 7. Applications in goal-directed therapy, monitor cardiac volume and guide volume therapy.

[0112] 8. Guide the implementation of right ventricular protective ventilation strategies and ensure the stability of cardiac output through monitoring.

[0113] The above are only the preferred embodiments of the present invention, and do not impose any other form of limitation on the present invention. Any modification or equivalent change made according to the technical essence of the present invention still falls within the scope claimed by the present invention.

Claims

1. A disposable intracardiac hemodynamic parameter monitoring catheter, comprising a catheter body (1), a CVP pressure transducer (2), an occlusion pressure balloon (3), a PAOP pressure transducer (4), a floating guiding balloon (5), an oxygen saturation SPO2 sensor conducting optical fiber (6), a temperature sensor (7), and a scale (8), an external device transmission interface (9), an occlusion pressure balloon injection port (10), and a floating guiding balloon injection port (11), characterized in that, The disposable intracardiac hemodynamic parameter monitoring catheter is provided with a catheter body (1). A temperature sensor (7) is arranged at the front end of the catheter body (1). A floating guiding balloon (5) is arranged at the rear end of the temperature sensor (7). A PAOP pressure transducer (4) is arranged at the rear end of the floating guiding balloon (5). An occlusion pressure balloon (3) is arranged at the rear end of the PAOP pressure transducer (4). A CVP pressure transducer (2) is arranged at the rear end of the occlusion pressure balloon (3). An occlusion pressure balloon injection port (10) and a floating guiding balloon injection port (11) are arranged at the rear end of the CVP pressure transducer (2). An external device transmission interface (9) is arranged at the tail end of the catheter body (1). An oxygen saturation SPO2 sensor conducting optical fiber (6) is installed inside the catheter body (1). A scale (8) is arranged outside the catheter body (1). Wires communicating the temperature sensor (7), the PAOP pressure transducer (4), and the CVP pressure transducer (2) are further arranged inside the catheter body (1). A catheter connecting the floating guiding balloon (5) and the floating guiding balloon injection port (11), and a catheter connecting the occlusion pressure balloon (3) and the occlusion pressure balloon injection port (10) are also arranged. The CVP pressure transducer (2), the PAOP pressure transducer (4), the oxygen saturation SPO2 sensor conducting optical fiber (6), and the temperature sensor (7) are connected to an external device through the external device transmission interface (9).

2. The disposable intracardiac hemodynamic parameter monitoring catheter according to claim 1, wherein The temperature sensor (7) arranged on the disposable intracardiac hemodynamic parameter monitoring catheter is arranged at a position 10 mm - 15 mm away from the front end of the catheter body (1). The CVP pressure transducer (2) is arranged at a position 280 mm - 400 mm away from the front end of the catheter body (1).

3. The disposable intracardiac hemodynamic parameter monitoring catheter according to claim 1, wherein The catheter body (1) of the disposable intracardiac hemodynamic parameter monitoring catheter is made of high-density polyethylene, and the diameter of the catheter body is 2.3 mm - 3 mm.

4. A disposable intracardiac hemodynamic parameter monitoring catheter according to claim 1, characterized in that, The occlusion pressure balloon (3) arranged on the disposable intracardiac hemodynamic parameter monitoring catheter is a tubular object, arranged at a position 70 mm - 100 mm away from the front end of the catheter body (1). Its diameter is 2.3 mm - 3 mm in the non-inflated state, 13 mm - 15 mm after inflation, and its volume is 1.5 ml - 1.8 ml.

5. The disposable intracardiac hemodynamic parameter monitoring catheter according to claim 1, wherein The PAOP pressure transducer (4) arranged on the disposable intracardiac hemodynamic parameter monitoring catheter is a tubular object, with a diameter of 2.3 mm - 3 mm, and is arranged at a position 50 mm - 70 mm away from the front end of the catheter body (1).

6. The disposable intracardiac hemodynamic parameter monitoring catheter according to claim 1, characterized in that, The floating guiding balloon (5) arranged on the disposable intracardiac hemodynamic parameter monitoring catheter is a tubular object, arranged at a position 20 mm - 40 mm away from the front end of the catheter body (1). Its diameter is 2.3 mm - 3 mm in the non-inflated state, 10 mm - 12 mm after inflation, and its volume is 1.3 ml - 1.5 ml.

7. A disposable intracardiac hemodynamic parameter monitoring catheter according to claim 1, characterized in that, The monitoring system of the disposable intracardiac hemodynamic parameter monitoring catheter uses an anti-divergent Kalman filtering method to filter the intracardiac pressure and aortic pressure collected by the catheter. The specific steps are as follows: Step 1. Estimate the current pressure value based on the (k - 1)-th collected pressure value. The formula is: X(k|k - 1) = AX(k - 1) Where: X(k - 1) is the blood pressure estimator at the (k - 1)-th sampling point; X(k|k - 1) represents the k-th blood pressure estimator obtained based on X(k - 1); A is the state transition matrix; Step 2. Introduce an anti-divergence factor and estimate the covariance of the current state based on the state value at the previous moment. The formula is: P(k|k - 1) = ζ(k)AP(k - 1)A T + Q Where: P is the state covariance matrix; P(k - 1) represents the state covariance matrix corresponding to the (k - 1)-th sampling point; P(k|k - 1) represents the estimate of the k-th state covariance matrix obtained based on P(k - 1); Q represents the process noise covariance matrix; ζ(k) is the anti-divergence factor, and the expression is: Among them: matrix N k and M k have the following specific expressions: Where: β represents the weakening factor; V0(k) represents the covariance matrix of the residual; R represents the observation noise covariance matrix; H represents the observation matrix; β is taken as 1.2; The specific expression of V0(k) is: Where: ρ represents the forgetting factor, and the parameter is 0.98; Step 3. Update the iterative parameters. The updated parameters include the covariance matrix of the residual, the Kalman filter gain, the state value at the current stage, and the state covariance matrix. Specifically: Where: Z(k) is the measured value of the k-th blood pressure; K(k) represents the Kalman filter gain.

8. A disposable intracardiac hemodynamic parameter monitoring catheter according to claim 7, characterized in that, In the monitoring system of the disposable intracardiac hemodynamic parameter monitoring catheter, the process of smoothing the filtered pressure value by using the weighted smoothing algorithm can be expressed as: where: f k represents the blood pressure value of the k-th sampling point after filtering; w i represents f k+i corresponding weighting factor; The m value is selected as -2 The n value is selected as 2.

Citation Information

Patent Citations

  • Self-adaptive high-order volume Kalman filtering method

    CN103927436A

  • Hemodynamic force simulation method and device

    CN113076705A

  • Ultrasonic catheter for monitoring in heart cavity

    CN116250861A