Intraarterial Advanced Hemodynamic Monitoring System and Method

Abstract

The invention relates to a minimally invasive hemodynamic monitoring system and method that enables continuous measurement of arterial cross-sectional area, arterial blood flow velocity, and intra-arterial blood pressure via a single arterial catheter that can be placed in a peripheral artery and has an ultrasonic transducer and blood pressure measurement sensor at its distal end, and automatic calculation of arterial blood output, changes in cardiac output, vascular resistance, and fluid responsiveness parameters using these measurements.

Description

1 TARIFF Intraarterial Advanced Hemodynamic Monitoring System and Method TECHNICAL AREA 5 The invention describes a device that can be implanted in a peripheral artery and transmit blood via an ultrasonic transducer at its distal end. Arterial cross-sectional area, arterial pressure measurement sensor is obtained via a single arterial catheter. continuous measurement of blood flow velocity and intra-arterial blood pressure, these measurements arterial blood flow, changes in cardiac output, vascular resistance, and fluid response were measured using 10 methods. Minimally invasive technology that enables automatic calculation of yieldability parameters. It relates to hemodynamic monitoring systems and methods. PREVIOUS TECHNIQUE Today, shock is the deprivation of oxygen and other vital nutrients that the organs that make up the body require. fatal, resulting from an insufficient supply of molecules for various reasons. It is a disease that requires rapid intervention and is frequently observed in intensive care units. Shock Early diagnosis and prompt management are crucial; otherwise, it can affect one or more organs. Organ failures can occur. These organ failures are permanent even if the shock condition improves. This is possible. Therefore, in patients facing shock, kidney, heart, and liver organs may be affected. permanent organ failure, psychosomatic disorders, loss of muscle strength, difficulty swallowing, walking Immobilization, or undesirable situations such as being constantly dependent on a ventilator. This can occur. To prevent these undesirable situations, shock syndrome... It should be identified, typed, and treated early. There are 25 subtypes of shock disease. These are obstructive shock, cardiogenic shock, distributional shock, and hypovolemic shock. All of these shock subtypes... The main problem in these types is insufficient blood supply to the organs. In obstructive shock, the main vascular problem is... Blood circulation is impaired due to blockages in the structures. In cardiogenic shock, blood... The heart's pump, which provides circulation, has weakened and is not pumping enough blood to the tissues. This is not possible. In distributional shock, however, a 30-degree shock affects the entire vascular network in our body. There is a loss of muscle tone (vasodilation) and an increase in permeability. Therefore, the blood vessel... The volume of blood inside decreases (intravascular fluid leaks out of the vessel) and at the same time the blood The blood pressure cannot be generated at the desired level, resulting in reduced blood flow to the tissues. In hypovolemic shock, the net fluid loss is due to a cause such as excessive bleeding, vomiting, or diarrhea. It exists and is associated with a decrease in intravascular circulating blood volume in organ 35. Blood supply is impaired. 2 Shock patients need to be quickly transferred to intensive care units upon diagnosis. Shock some for the evaluation, classification and management of patients in intensive care Biochemical and physical parameters are used. Various biochemical parameters are included within these parameters. These include blood tests, blood gas analyses, and serum lactate level measurement. Biochemical parameters are not included in this invention. Physical parameters include 5. Cardiac output, systemic vascular resistance, blood pressure, fluid responsiveness, central venous pressure It is located there. The measurement of these parameters constitutes the main subject of this invention. This Physical parameters can be measured with advanced hemodynamic monitoring devices. However, the method used by each of the devices currently in use, which are described below in turn It has its own specific limitations and advantages. Transthoracic echocardiography 10 With transthoracic ultrasound (TTE), some hemodynamic parameters can be obtained non-invasively. TTE can be used to examine the heart... Flow rate measurement can be done directly. Simultaneously, central venous pressure and blood pressure can be measured. If known, systemic vascular resistance can be calculated indirectly. Central venous resistance with TTE. Blood pressure can be estimated indirectly based on measurements of the inferior vena cava. Fluid responsiveness can be assessed with TTE. For example, respiratory response in maximal aortic blood flow. The level of variation can be measured, the collapse / distensibility of the inferior vena cava can be measured, and the heart... Passive leg raising (PLR) or "mini" by utilizing flow rate measurement. A "fluid challenge" (MFC) test can be performed. However, in order to take all these measurements... a specialist who is well-trained in echocardiography and hemodynamic monitoring A physician is needed, therefore these measurements should be taken by a nurse or any other physician. 20 It is not possible to do so. TTE measurements may reveal certain anatomical problems in the patient, or difficulties in positioning the patient. open wounds on the chest wall, mechanical ventilation, COPD (Chronic obstructive pulmonary disease) This is not always possible due to reasons such as the presence of lung disease, or image 25 Inadequacies in quality reduce the reliability of the measurements. In addition, TTE Continuous measurement of hemodynamic parameters is not possible with this method and can only be done intermittently. Measurements can be made. For all these reasons, shock patients should be evaluated using TTE. It is quite limited. TTE is performed by a physician with sufficient experience, provided the image quality is adequate. It can be used intermittently in the assessment of shock patients. Another advanced 30 Hemodynamic monitoring is performed using pulmonary artery catheterization (PAC). Thermodilution is the gold standard method for hemodynamic monitoring. It is a method, but due to its invasive nature and potentially serious complications, it is not widely used today. Limited, selected patient group (patients in shock with advanced right and left cardiac failure) It is not used otherwise. Another advanced hemodynamic monitoring method is 35 This is transpulmonary thermodilution (TPTD). In this method, hemodynamics are improved minimally invasively. Parameters can be obtained using this method, transpulmonary thermodilution. 3 Cardiac output is measured every 8 hours, and this measured cardiac output is reliable, like PAC. However, this Continuous cardiac output measurement other than main measurements is called "pulse pressure contour analysis (PPCA)". Measurements continue indirectly based on "pulse contour analysis". Transpulmonary For thermomodulation, one of the central venous vessels (usually the internal jugular vein) is used. a catheter placed into the (or subclavian vein) and one of the arterial vessels 5 This requires a catheter to be placed in a (usually femoral artery or radial artery). A small amount (usually 15 mL) of cold compresses is injected into a central venous catheter. +4 °C) saline solution (SF) is administered to the right heart, lungs, left heart, and arterial vessels, respectively. It passes through the tip of the catheter that has been inserted into the arterial vessel. The catheter has a thermistor at its tip used to measure the temperature of the blood. This is cold SF 10. Following the application, the arterial thermistor detects blood temperature over time. Cardiac output is calculated using the obtained curve. In TPTD, cardiac output is calculated based on NBKA. Pulmonary output measurements indicate tachycardia, atrial fibrillation, severe aortic valve insufficiency, and increased pulmonary function. Its reliability decreases in situations such as capillary permeability. Central venous pressure during TPTD. and arterial blood pressure is already 15 located within the arterial and venous vessels. It can be measured directly via catheters. Fluid responsiveness can be assessed with TPTD. For example... Pulse pressure variation (PPV) and stroke volume variation (SVV) can be used. In addition, continuous cardiac output measurement can be provided for the assessment of fluid responsiveness. PLR or MFC tests can be easily performed. Despite all these positive aspects, the TPTD method requires well-trained hemodynamic monitoring. This requires a physician with sufficient experience in the field. Continuous cardiac output measurements are recommended for NBKA. It is based on and measurement errors can occur in various situations. Another advanced hemodynamic approach... The monitoring method, however, is solely based on NBKA (Non-Biological Cardiac Output) estimation. This In this method, only 25 injectors are placed inside an arterial vessel (usually the radial or femoral artery). There is a catheter. Through this catheter, blood pressure is measured invasively over time, and the obtained pulse waveform and other clinical information about the patient (e.g., gender, age, height) Cardiac output is estimated based on (such as) measurements. Measurements are taken continuously. However, the heart Its use in shock patients in intensive care due to the inability to directly measure its flow rate. It is not preferred; rather, advanced hemodynamic monitoring is more commonly performed in operating room settings. 30 It is used for this purpose. In addition, there are applanation tonometers, "volume clamps," etc. Some non-invasive, continuous measurement devices used for hemodynamic monitoring There are also other methods. However, the use of these methods is limited in patients with severe circulatory disorders. It is unsuitable, and measurement errors can be quite high. As can be seen... The advanced hemodynamic monitoring techniques used today have several limitations. 35 Because of these limitations, there is a need for methods that provide better hemodynamic monitoring. That is the subject. 4 The main problems encountered with the technology as it is known are as follows:  Cardiac output measurement in current minimally invasive hemodynamic monitoring techniques It can be measured continuously but indirectly (estimated, based on calculations). TPTD In this method, measurements made by applying cold SF during calibration are directly obtained, but only after 5 These are intermittent cardiac output measurements. However, this is necessary after the calibration process. Continuous cardiac output measurements are based on the NBKA method and are indirect measurements. Apart from this, the NBKA method, which is based solely on arterial catheterization, is similar. Cardiac outputs of patients are obtained based on parameters such as gender and body weight. It is estimated by evaluating the invasive blood pressure graph obtained and is measured indirectly. 10 Indirect measurements of cardiac output can be inaccurate in some clinical situations. This can lead to inaccurate measurements and misdirected treatment of patients.  PPV and SVV parameters from fluid responsiveness tests are only available to mechanical ventilators. fluid in a restricted patient group that is bound, has no spontaneous breathing, and is passively ventilated It can be used as a responsiveness parameter. Those with spontaneous breathing or who are intubated 15 It is not available for the patient group that does not have this condition. Apart from that, there are serious problems in patients. Tachycardia, arrhythmia, severe heart valve insufficiency, increased pulmonary capillary leakage, pulmonary The use of PPV and SVV in conditions such as hypertension and decreased pulmonary compliance. This is not appropriate. Therefore, the appropriate use of PPV and SVV in intensive care is crucial. This is possible in a very small percentage of patients. Therefore, some clinics... In some cases, it may be necessary to use other fluid responsiveness parameters. However, continuous cardiac output measurement is required for the use of other parameters such as MFC or PLR. The use of one of these systems is required. As explained above, continuous heart Devices that measure cardiac output do not directly measure cardiac output; they measure it indirectly. It measures the flow rate. Therefore, the measurement is prone to errors in some clinical situations and 25 It can misdirect the patient's treatment.  PLR and MFC tests are not calculated automatically; they require the user's / physician's pre-test data and After the test, cardiac output values ​​are recorded and the patient is expected to calculate it themselves. This During the calculation, the physician carefully examines all the data to determine the highest possible heart rate. It is expected to determine the flow rate. In this case, the test is prone to errors, along with human senses. 30 and tests based on cardiac output variability, such as PLR and MFC, are prone to errors. This situation is inevitable. A catheter inserted with so much difficulty and risk... A key endpoint of minimally invasive systems requiring fluid responsiveness (evaluation) associating it with human senses in this way is quite significant. That's the problem. 35  In current systems, systemic vascular resistance (SVR) is measured according to the following formula: It is calculated. SVR is the ratio of blood flow to blood flow within a vessel where blood flow is present. It is the resistance applied and the relationship between blood pressure (BP), SVR, and cardiac output (CA). This is shown in the following formula. KB = SVR x KD Therefore, to calculate SVR, we need to know the cardiac output and blood volume within the same vessel. It is necessary to determine the pressure values. Today, the TPTD method measures the main cardiac output. During the measurements, both blood pressure and current heart rate are measured in the area where the catheter is inserted. Since the flow rate can be calculated, the SVR can be accurately determined, however, this main 10 Errors in SVR measurements based on continuous cardiac output measurements, apart from other measurements. This is observable. Therefore, SVR measurements are not dynamic. As a result of research conducted in the literature, it has been determined that the application number PCT / US2014 / 027133 and International invention titled "Hemodynamic Monitoring Device and Methods of its Use" 15 A patent application has been found. The application concerns blood within the superior vena cava. measurement of blood flow velocity via intravascular Doppler probe and the obtained blood flow velocity The patient's fluid responsiveness is assessed by correlating the data with respiratory cycle data. It is related to a hemodynamic monitoring system that allows for the assessment of the condition. However In the aforementioned application, artery 20 is treated via a single arterial catheter placed in a peripheral artery. Determination of the cross-sectional surface area using B-mode ultrasonography, catheter cross-sectional area of ​​arterial cross-section subtraction of the area, calculation of arterial blood volume and arterial blood flow, intra-arterial direct measurement of blood pressure and the use of this data to determine arterial vascular resistance and fluid a system that enables the simultaneous and continuous determination of responsiveness parameters No evidence related to this has been found. 25 Ultimately, the problems mentioned above, which cannot be solved with current technology, are the subject of this technical analysis. This has made it necessary to make an innovation in the field. A BRIEF DESCRIPTION OF THE INVENTION The present invention aims to eliminate the aforementioned disadvantages and introduce new technologies to the relevant technical field. Advanced intra-arterial hemodynamic monitoring system and method to bring advantages It is related to. 6 The main purpose of the invention is to provide an additional artery via an arterial catheter placed in a single peripheral artery. advanced hemodynamic monitoring parameters without the need for invasive measurement methods The goal is to ensure that it is obtained continuously, instantly, and automatically. Another aim of the invention is to detect 5 via an ultrasonic transducer located at the distal end of the catheter. Determination of the cross-sectional surface area of ​​the artery using B-mode ultrasonography technique to provide. Another objective of the invention is to reduce the known cross-sectional surface area of ​​the catheter from the cross-sectional surface area of ​​the artery. By removing it, the net cross-sectional surface area through which the blood passes is automatically calculated as 10. The aim is to enable the calculation. Another aim of the invention is to measure blood flow within an artery using continuous wave Doppler technology. continuous measurement of speed as a function of time and obtaining a speed-time graph to provide. 15 Another aim of the invention is to obtain the integral of the velocity-time graph over a specific time interval. the distance traveled by the blood is determined and this value, along with the net cross-sectional surface area, is used to The aim is to enable the calculation of arterial blood volume and arterial blood flow rate. Another aim of the invention is to measure arterial blood levels before and after fluid administration. Fluid responsiveness tests, such as mini fluid loading tests, can be performed using flow rate values. The goal is to enable automatic evaluation. Another aim of the invention is to measure arterial blood pressure before and after a passive leg raise test. The patient's fluid responsiveness status can be determined using blood flow rate values. The aim is to ensure its identification. Another aim of the invention is to improve respiration in patients who breathe spontaneously or are mechanically ventilated. Maximum and minimum arterial blood flow velocities occurring throughout the cycle 30 Calculation of fluid responsiveness parameters by determining their changes to provide. Another purpose of the invention is to monitor blood pressure through a blood pressure sensor located on the catheter. The aim is to enable direct and continuous measurement of intra-arterial blood pressure. 35 7 Another aim of the invention is to simultaneously obtain arterial blood pressure and arterial blood volume. vascular resistance value of the arterial region measured using flow rate values The goal is to enable automatic calculation. Another aim of the invention is to measure arterial cross-sectional area, blood flow velocity, blood pressure, arterial blood output, 5 Vascular resistance and fluid responsiveness values ​​can be measured via wired or wireless connection. The goal is to transmit the data to a monitor. Another purpose of the invention is to display the calculated hemodynamic parameters on a monitor, smartphone, or The goal is to enable real-time monitoring via a tracking device such as a tablet. 10 Another aim of the invention is to provide treatment for patients requiring intensive care, operating rooms, and advanced hemodynamic monitoring. Multiple measurement methods used in other clinical fields can be performed with a single minimally invasive catheter. The aim is to ensure their integration within the system. All the purposes mentioned above and those that will emerge from the detailed explanation below. The present invention is designed to implement an intraarterial advanced hemodynamic monitoring system. Its characteristic is; - an arterial catheter that can be placed inside a peripheral artery, - B-mode 20 located in the distal section of the arterial catheter in question. Determining the cross-sectional surface area of ​​the artery and continuous analysis using ultrasonography techniques. The time-dependent determination of blood flow velocity within an artery is determined using wave Doppler technology. at least one ultrasonic transducer that enables measurement, - positioned on the arterial catheter in question and measuring intra-arterial blood pressure at least one blood pressure measurement sensor that allows direct measurement, 25 - Arterial cross-sectional surface area and blood flow velocity obtained from ultrasonic transducer. using the previously known cross-sectional surface area of ​​the arterial catheter to obtain the data, the blood blood obtained over a specific time interval that determines the net cross-sectional surface area through which it progresses By processing flow velocity data, arterial blood volume and arterial blood flow rate can be determined. calculates arterial blood flow rate and / or blood flow velocity obtained at different times 30 Determining the fluid responsiveness parameter by comparing values ​​and intra-arterial blood vascular resistance parameter based on blood pressure and arterial blood flow data. at least one unit of measurement and calculation, - measured and calculated hemodynamic data via wired and / or wireless means. at least one data communication unit that enables the transmission and 35 8 - Arterial cross-sectional surface area, blood flow velocity, intra-arterial blood pressure, arterial blood volume, arterial blood flow, fluid responsiveness parameter, and vascular resistance at least one monitoring unit that enables the display of at least one of the parameters It includes. The best way to utilize the advantages of the existing invention, together with its structure and additional elements. For it to be understood, it must be considered together with the figures explained below. BRIEF DESCRIPTION OF THE FIGURES Figure 1 shows a representative view of the intraarterial advanced hemodynamic monitoring system that is the subject of this invention. It is a representation. Figure 2 shows the calculations and records made in both time intervals (times T1 and T2). It is a representative illustration of the speed-time graph. Figure 3 shows the blood flow in the arterial space during inspiration in patients with spontaneous breathing. that the blood flow rate during exhalation (minVa) is lower than the blood flow rate during exhalation (maxVa) It is a representative representation that shows. Figure 4 shows passively ventilated, intubated patients without spontaneous respiratory effort. the blood flow velocity in the arterial space at the end of inspiration (maxVa) compared to the blood flow velocity during expiration This is a representative illustration showing that it is greater than the current rate (minVa). 20 Figure 5 shows other aspects of the intraarterial advanced hemodynamic monitoring system that is the subject of this invention. It is a representative illustration. The drawings do not necessarily need to be scaled and are necessary for understanding the invention. Details that are not present may have been overlooked. Furthermore, at least to a large extent, 25 Elements that are identical or at least have substantially identical functions are numbered the same. It is shown. REFERENCE NUMBERS 1. Arterial catheter 2. Ultrasonic transducer 3. Blood pressure measurement sensor 4. Unit of measurement and calculation 5. Data communication unit 35 6. Monitoring unit 9 A1. Cross-sectional surface area of ​​the artery A2. Previously known cross-sectional surface area of ​​the arterial catheter. A3. Velocity-time integral Va. Blood flow rate KBa. Intra-arterial blood pressure 5 Ha. Arterial blood volume Yes. Arterial blood flow preDa. Arterial blood flow before testing. PostDa. Arterial blood flow after test. preKD. Cardiac output before test 10 postKD. Cardiac output after test. maxVa. Maximum blood flow rate. minVa. Minimum blood flow rate. VRa. Arterial vascular resistance value. DETAILED DESCRIPTION OF THE INVENTION This detailed description explains the subject of the invention: advanced intraarterial hemodynamic monitoring. The system and method are solely aimed at a better understanding of the subject, with no limiting effects. This is explained with examples that will not create a problem. 20 Within the scope of the invention, an arterial catheter (1) is used, such as a radial artery, femoral artery or brachial artery. a device placed inside a peripheral artery that allows hemodynamic measurements to be performed This refers to the catheter. With this invention, the arterial blood flow obtained is directed to the artery where the catheter is inserted. This is the cardiac output. To calculate the main cardiac output, the catheter tip should be positioned as proximal as possible. 25 It needs to be advanced into the aorta. When this is not possible, a method such as echocardiography is used. The methods allow a single main cardiac output value to be defined in the device, and thus The device continues to measure cardiac output. Ultrasonic transducer (2), arterial catheter. (1) The cross-sectional surface of the artery is examined by positioning it in the distal section and using B-mode ultrasonography technique. The area (A1) and the blood flow velocity (Va) within the artery using continuous wave Doppler technique are 30 the transceiver structure that enables measurement; blood pressure measurement sensor (3), arterial catheter (1) by positioning it on the surface, it allows for the direct and instantaneous measurement of intra-arterial blood pressure. the sensor providing; measurement and calculation unit (4), ultrasonic transducer (2) and blood By processing the data obtained from the pressure measurement sensor (3), arterial blood volume, arterial blood cardiac output, amount of change in cardiac output, fluid responsiveness parameters, and vascular resistance 35 The unit that calculates the values; data communication unit (5), measured and calculated hemodynamic The unit that enables the transmission of data via wired and / or wireless means; the monitoring unit (6) The transmitted hemodynamic data is displayed in real-time via monitor, smartphone and / or tablet. It refers to the unit that enables monitoring and tracking. This invention measures arterial intravascular blood flow velocity (Va), blood pressure, and arterial intravascular cross-section. Data such as surface area are obtained automatically, based on instantaneous and direct measurements. This is possible. This invention application, which will be placed in only a single arterial area, Fluid responsiveness based on direct cardiac output measurement via a defined catheter. Tests (PLR, MFC, PPV, SVV, etc.) are measured directly. SVR and cardiac output are also measured with the same catheter. Measurements can be made directly and continuously. Intravascular direct blood pressure This measurement helps to overcome the difficulties encountered in blood pressure measurements. 10 The invention is related to the fields of medicine and biomedicine and involves blood sampling via intravascular ultrasonography. Intravascular invasive blood pressure can be calculated using flow velocities (Va) and vessel cross-sectional area. Measurements will be taken. With this device and catheter, advanced hemodynamic parameters (cardiac output, blood pressure, systemic 15 (vascular resistance) can be detected with detailed and continuous measurements, the same In addition to PPV / SVV tests, other tests based on changes in cardiac output, such as PLR and MFC, are also used. It will be integrated with the device. For MFC measurement, the physician / user will monitor the device. He will tap the tab that will start the MFC test. Before starting the test... How many mL (preset 100 mL) and how many seconds the liquid will be pushed during the test (preset 20 mL) (as 60 seconds) and to calculate the change in cardiac output after the push procedure. The minimum waiting time (60 seconds as a preset) can be specified in seconds. After the device is notified that the push procedure has been initiated, it obtains the continuous cardiac output. Pre-test cardiac output and post-test maximal cardiac output based on measurements It can automatically calculate and display the MFC value as a percentage on the monitor. PLR 25 To start the test, you will first need to tap the PLR ​​start tab on the device. The device In this case, the continuous cardiac output measurements obtained will be used for pre-test cardiac output assessment. Then, after the user / physician places the patient in the PLR ​​position, the PLR ​​on the device... It will click the "position completed" tab. For the previously set PLR account. After the minimum waiting time has passed, the device displays 30 of the continuous measurement values ​​it obtains. The system will obtain cardiac output measurements after the maximal test and consequently determine the PLR ​​value as a percentage. This will allow the test to be displayed on the screen. This will make it much easier to conduct the test and for people. Errors will be prevented, and tests will be automated. Tests like PLR ​​and MFC will be quite effective. most intensive care units are reliable and whether intubated or not, and whether or not they have spontaneous breathing. These are tests that can be used on the care patient. These tests are easily used thanks to this device, PPV 35. and the use of tests that have very limited use in critically ill patients such as SVV. This will largely eliminate the need for tests like PPV and SVV. Nevertheless, 11 If needed, PPV can be administered via a pressure transducer located on the catheter. Thanks to the ability to continuously calculate the pulse volume (ultrasonic transducer (2)) SVV can be calculated (via, for example, MFC test in patients without venous catheter) such as the inability to perform the PLR ​​test or the inability to perform the PLR ​​test due to excessive intra-abdominal pressure. (in cases). 5 With the new method described below, patients undergo continuous, direct cardiac surgery minimally and invasively. Blood flow rate, blood pressure, and systemic vascular resistance measurements can be obtained, and fluid responsiveness can be assessed. Tests can be performed. No additional method is needed for any of these measurements. This The method is an intravascular ultrasonography and intravascular 10 already used for other purposes. It is related to Doppler methods. Today, intravascular ultrasonography is used to examine the inside of the coronary arteries. in evaluating the structure, in assessing the intra-arterial lumen patency, i.e., the state of stenosis, It can be used to evaluate the structure of atheroma plaque. In addition, it can be used in the pulmonary artery. Cardiac output can be measured using intravascular ultrasonography performed at this level. However, intravascular ultrasonography in shock patients, as mentioned above, is more advanced than 15 It is not used for hemodynamic monitoring purposes. With the new method described below... Cardiac output measurement, systemic vascular resistance measurement, blood pressure measurement, and fluid response measurement. Compatibility tests can be performed via a single catheter without the need for any other method. It is possible to do this. The patient can receive injections into any peripheral artery (radial artery, femoral artery, a catheter with an ultrasonic transducer (2) at its end to be placed in the brachial artery etc.) 20 via blood flow velocities (Va) passing through the arterial space and the cross-sectional area of ​​blood passing through the artery Continuous measurements of cardiac output and fluid responsiveness status are calculated. can be evaluated. In Figure 1, a device with an ultrasound receiver / transmitter (transducer) at its end is shown. The image shows the catheter and the insertion of this ultrasonic catheter into the artery. Here, A1 A1 represents the cross-sectional surface area of ​​the artery, and A2 represents the cross-sectional surface area of ​​the catheter. A1 section 25 The area is controlled via a transducer located at the tip of the ultrasonic catheter, in B mode. This can be calculated using ultrasonography techniques. The A2 sectional area is currently... The manufactured catheter has a structural value that is known and fixed at the time of manufacturing. Other One definition is the variable Va, which indicates the velocity of blood flow within an artery. The Va variable... "Continuous wave Doppler" capability via the transducer located at the tip of the ultrasonic catheter. 30 It can be calculated continuously using and determined over time (Figure 2). Calculations were made and recorded within both time intervals (times T1 and T2) in 2 days. The velocity-time graph is shown. The area value A3 represents the velocity obtained between times T1 and T2. It represents the area under the time graph (the integral of the velocity-time graph). Here This defined AZ value represents the total distance the blood travels within the vessel between T1 and T2 intervals, which is 35 minutes. It shows the distance. Therefore, it progresses by moving in the T1-T2 time interval. 12 The total volume of blood, Ha, can be calculated using the following formula. In the formula below, (A1-A2) represents the volume of blood. It represents the net surface area over which it spreads: Ha = A3 x (A1-A2). Flow rate is defined as the volume of blood passing through a unit surface area per unit time. The blood flow rate (Da) in the measured arterial area is calculated according to the following formula: computable: Da = Ha / (T2-T1). 10 Because this method allows for continuous measurement of blood flow in the arterial area being measured, the heart... Liquid responsiveness parameters are determined by calculating the amount of change in flow rate. This can be done. For example, in the "mini fluid challenge" test, the patient is given 100 ml in 1 minute. SF is given as an IV bolus. The aim of this test is to measure the amount of intravenous fluid given to the patient in 15 seconds. The goal is to determine how much of an increase in cardiac output this will cause. If after the test... If there is a significant increase in cardiac output, this indicates a positive result to us, and this After this stage, the patient may receive higher volume fluid therapy. Mini Cardiac output before fluid administration (preKD) and fluid during the fluidity challenge test. Cardiac output (post-cardiopulmonary output) is calculated 2 minutes after administration, and the rate of change in cardiac output is 20. The test result is calculated by means of this calculation. Similarly, arterial analysis is performed to determine this result. Pre-test arterial flow rate (preDa) and test results are obtained via an ultrasonic catheter placed in the area. It is necessary to determine the post-arterial flow rate (postDa). Determination of preDa and postDa. After completion, preKD and postKD are calculated according to the following formulas. preKD = kx preDa postKD = kx postDa The coefficient k here represents the distribution of the total cardiac output over the measured arterial area. It indicates and is a constant value for pre- and post-test measurements. For example, with echocardiography, 30 a measured cardiac output value is defined in the system via the device's monitor In this case, a constant value of k can be calculated. After calculating this k value, the device's continuous operation is determined. This allows for the calculation of the main cardiac output, such as in the Mini Fluid Challenge (MFC) test. Post-test heart rate analysis for tests calculated based on the amount of change in cardiac output. The amount of change in flow rate (dmKD) is calculated according to the following formula: 35 dmKD = ((postKD - preKD) x 100) / postKD 13 The necessary simplification occurs when preKD and postKD are replaced with their respective equivalents in this formula. When this is done, the following formula is obtained. dmKD = ((kx postDa - kx preDa) x 100) / kx postDa 5 dmKD = (kx (postDa - preDa) x 100) / kx postDa dmKD = ((postDa - preDa) x 100) / postDa As seen, the change in cardiac output after a test like the "mini fluid challenge" test. amount (dmKD) a catheter with an ultrasonic transducer placed in a peripheral artery 10 It can be understood that this can be calculated automatically through this method. Another example is the amount of increase in cardiac output in conjunction with the passive leg raise test. It is a calculation. In the passive leg raise test, the patient is given an intravenous fluid bolus. This method utilizes the ability to return blood from the patient's lower extremities back to the heart without performing any other procedure. 15 If a patient is lying supine at an angle of 30-45 degrees, and then completely on their back... If the person is lying down and their legs are raised at a 45-degree angle, the lower extremities... Approximately 250-300 milliliters of blood return to the right heart, and with this maneuver, cardiac output increases. If a sufficient increase is detected, patients are said to be responsive to fluids. "mini fluid" Pre-KD and post-test 20, obtained while the patient is in the supine position, as in the "challenge" test. The dmKD value is obtained similarly by calculating postKD at 2 minutes according to the following formula: It is done. dmKD = ((postDa - preDa) x 100) / postDa In addition, this method continuously monitors the velocity of blood in the measured arterial area. because it can be done, the blood flow velocities in arterial vessels during the respiratory cycle (Va) Change amounts can be calculated. The amount of change in blood flow velocity in the arterial space. It can be used as a fluid responsiveness parameter dependent on cardiopulmonary interaction. Figure 3-4 shows the change in arterial blood flow velocity over time during the respiratory cycle (30). The change has been shown. The graph pattern in patients with spontaneous breathing versus those with passive ventilation. The radiographic pattern differs in intubated patients. In patients with spontaneous breathing... Blood flow rate in the arterial space during inspiration (minVa) and blood flow rate during expiration It is lower than the current rate (maxVa) (Figure-3). Conversely, passively In ventilated, intubated patients without spontaneous respiratory effort, the end of inspiration is 35. Blood flow velocity in the arterial space (maxVa) is compared to blood flow velocity during expiration (minVa). It is higher compared to others (Figure-4). Therefore, in patients with spontaneous respiratory effort, again 14 similarly measured by inserting a catheter with an intraarterial ultrasonic transducer (2). maxVa and minVa values ​​and arterial blood flow during the respiratory cycle The amount of change (dmVa) can be determined: dmVa = ((maxVa-minVa) x 100) / maxVa. 5 Similarly, maxVa and were obtained in intubated patients without spontaneous respiratory effort. Based on the minVa values, the dmVa value can be determined according to the following formula: dmVa = ((maxVa-minVa) x 200) / (maxVa + minVa). 10 This was obtained in both patient groups with spontaneous respiratory effort and those receiving passive ventilation. The dmVa value can be used as a fluid responsiveness parameter. In addition to this, via a blood pressure measurement sensor (3) placed at the end of the defined arterial catheter (1). Intra-arterial blood pressure (BPb) can be measured instantaneously. The intra-arterial blood pressure measurement value is 15 In order to obtain a clear reading, the device measures the air pressure outside the patient. It requires a separate pressure sensor. This pressure sensor, located outside the patient, controls the device. It will be located inside the monitor. It measures air pressure from the intra-arterial pressure value. Dynamically determining the patient's intra-arterial blood pressure value by subtracting the sensor's pressure. It will be accessible as follows. Simultaneously, arterial cardiac output (Da) is continuously monitored using ultrasonic imaging. Since intra-arterial vascular resistance (VRa) can be measured via a sensor, the value above is as follows: According to the formula described, it can be obtained instantaneously (KBa = VRa x Da). The aforementioned Ha, Parameters such as Da, A1, A2, A3, maxVa, minVa, and VRa are calculated automatically for the device. Data transfer can be monitored via the screen. This relates to arterial ultrasonic catheterization. The monitor can be connected via cable or wirelessly. In addition, 25 mobile through software on mobile devices such as smartphones or tablets The device data can also be monitored with other devices. This invention enables advanced hemodynamic monitoring. all necessary intensive care units, operating rooms, and other areas have potential It has a wide range of applications. Its minimally invasive nature and advanced hemodynamics with a single catheter. The advantage is that monitoring parameters will be obtained. 30

Claims

REQUESTS 1. It is an intraarterial advanced hemodynamic monitoring system, the feature of which is; - an arterial catheter that can be placed into a peripheral artery (1), 5 - B-mode catheter located in the distal section of the said arterial catheter (1) Determination of the cross-sectional surface area (A1) of the artery using ultrasonography technique and the blood flow velocity within the artery can be determined using continuous wave Doppler technique. (Va) at least one ultrasonic transducer (2) that enables measurement in relation to time, - positioned on the said arterial catheter (1) and intra-arterial blood 10 at least one blood pressure measuring device that allows direct measurement of blood pressure (KBa) sensor (3), - Arterial cross-sectional surface area (A1) and blood flow obtained from ultrasonic transducer (2). obtaining velocity (Va) data, the previously known cross-sectional area of ​​the arterial catheter (1) Determine the net cross-sectional surface area through which blood flows using (A2), at a specific time 15 By processing blood flow velocity data obtained within the range, arterial blood volume (Ha) can be determined. and calculates arterial blood flow (Da) from arterial blood flows obtained at different times. Fluid responsiveness by comparing blood output and / or blood flow velocity values. parameters that determine intra-arterial blood pressure (KBa) and arterial blood flow (Da) At least one measurement that calculates the vascular resistance parameter based on the data 20 and unit of calculation (4), - measured and calculated hemodynamic data via wired and / or wireless means. at least one data communication unit (5) that enables the transfer of data and - Arterial cross-sectional surface area (A1), blood flow velocity (Va), intra-arterial blood pressure (KBa), arterial blood volume (Ha), arterial blood flow rate (Da), fluid responsiveness 25 visualization of at least one of the following parameters: vascular resistance and vascular resistance. at least one monitoring unit providing (6) It includes.

2. The system according to claim 1, and its feature is; the unit of measurement and calculation (4), T1 and T2 30 The area under the blood flow velocity-time graph obtained between the specified times is the velocity- Determining the time integral as (A3), the velocity-time integral (A3) in question is the blood. It uses it as the distance traveled within the artery between T1 and T2 times. arterial blood volume (Ha) and arterial blood flow rate (Da); Ha = A3 × (A1 − A2) and Da = It is a unit that calculates according to the relationship Ha / (T2 − T1). 35 3. The system according to claim 1 or 2, and its characteristic is that the unit of measurement and calculation is (4); 16 - mini fluid initiated via monitoring unit (6) with physician / user guidance Arterial blood pressure measured before load loading test (MFC) / passive leg raise test (PLR) blood flow rate is measured as pre-test arterial blood flow rate (preDa), and post-test blood flow rate. Arterial blood flow rate is determined as post-test arterial blood flow rate (postDa), - a constant representing the distribution of total cardiac output across the measured arterial region 5 Pre-test cardiac output is calculated using a coefficient k, preKD = k × preDa, and test output is calculated as follows: Determining post-cardiac output according to the relationship postKD = k × postDa, - The amount of change in cardiac output; dmKD = ((postDa − preDa) × 100) / postDa calculating according to the relation, - In patients with spontaneous respiratory effort, 10 within a respiratory cycle maximum blood flow rate (maxVa) and minimum blood flow rate (minVa) By determining the amount of change in blood flow velocity, dmVa = ((maxVa − minVa) × 100) / Calculates according to the maxVa relation and - Blood flow in patients who do not have spontaneous respiratory effort and are passively ventilated. The rate of change is calculated as: dmVa = ((maxVa − minVa) × 200) / (maxVa + minVa) 15 blood pressure measurement sensor (3) and ultrasonic which calculate according to the relationship pulse pressure based on data obtained via transducer (2) Calculating the variation in stroke volume (PPV) and / or stroke volume variation (SVV) and fluid response. It is a unit that determines the availability status.

4. A system according to any of claims 1-3, whose characteristic is; unit of measurement and calculation. (4), intra-arterial blood pressure (KBa) measured by the blood pressure measurement sensor (3) Using arterial blood flow (Da) data, determine the arterial vascular resistance value (VRa); It is a unit that calculates according to the relation VRa = KBa / Da.

5. The system is compliant with Claim 1 and its feature is that the monitoring unit (6) calculates the hemodynamic receiving data via data communication unit (5) and a monitor, smartphone and / or It is an electronic device in the form of a tablet.

6. At least one ultrasonic transducer in the distal section of a peripheral artery (2) 30 and via an arterial catheter (1) with at least one blood pressure measurement sensor (3) It is an advanced intraarterial hemodynamic monitoring method performed, and its characteristic feature is; - using B-mode ultrasonography technique via ultrasonic transducer (2) Determination of the cross-sectional surface area (A1) of the artery, - The cross-sectional surface area of ​​the arterial catheter (1) determined and fixed during production is 35 (A2) obtaining, 17 - from the cross-sectional surface area of ​​the artery (A1) to the cross-sectional surface area of ​​the arterial catheter (A2) Determining the net cross-sectional surface area through which blood flows by removing it. - using continuous wave Doppler technique via ultrasonic transducer (2) The measurement of blood flow velocity (Va) within an artery as a function of time. - A velocity-time 5 is derived from blood flow velocity data measured between times T1 and T2. creating the graph, - the area under the velocity-time graph between times T1 and T2 Determined as the velocity-time integral (A3), Times T1 and T2 are determined using the net cross-sectional surface area with the velocity-time integral (A3). Calculation of arterial blood volume (Ha) progressing between 10 - Arterial blood volume (Ha) and the time difference between T1 and T2 are used to calculate arterial blood volume. Calculation of blood flow rate (Da), - Arterial blood flow rate (Da) and / or blood flow velocity (Va) measured at different times by comparing the values ​​of the fluid responsiveness parameter determination, 15 - direct measurement of intra-arterial blood pressure (KBa) via blood pressure measurement sensor (3) measuring, - Vascular resistance using intra-arterial blood pressure (BP) and arterial blood flow (DA). calculation of the parameter and - Measured and calculated hemodynamic data transmitted via wired and / or wireless means to a 20 transfer to the monitoring unit (6) It includes the steps of the process.

7. The method is based on claim 6 and its characteristic is that blood flows through the arteries between times T1 and T2. Determining the distance covered within it as the velocity-time integral (A3), arterial 25 Blood volume is calculated according to the relationship Ha = A3 × (A1 − A2), and arterial blood Calculating the flow rate according to the relationship Da = Ha / (T2 − T1) is done using the following steps: It includes.

8. The method is according to claim 6 or 7, and its characteristic is; 30 - mini fluid initiated via monitoring unit (6) with physician / user guidance Arterial blood count before load loading test (MFC) / passive leg raise test (PLR) Determining the blood flow rate as pre-test arterial blood flow rate (preDa), - the arterial blood flow rate after the test in question, post-test arterial blood The flow rate is determined as (postDa), 35 18 - pre-test cardiac output is calculated as preKD = k × preDa and post-test cardiac output is calculated as follows: Determined according to the relationship postKD = k × postDa, - The amount of change in cardiac output is calculated as: dmKD = ((postDa − preDa) × 100) / postDa Calculation according to the relationship, - Maximum blood flow velocity (maxVa) and 5 in patients with spontaneous respiratory effort The amount of change in blood flow velocity can be determined using the minimum blood flow velocity (minVa); Calculation according to the relation dmVa = ((maxVa − minVa) × 100) / maxVa and - Blood flow in patients who do not have spontaneous respiratory effort and are passively ventilated. The rate of change is calculated as: dmVa = ((maxVa − minVa) × 200) / (maxVa + minVa) Calculation according to the relationship, blood pressure measurement sensor (3) and ultrasonic 10 pulse pressure based on data obtained via transducer (2) Fluid response by calculating the variation in stroke volume (PPV) and / or stroke volume variation (SVV). Determining the availability status, According to the relationship between cardiac output = kxDa, another method can be used, for example... After the cardiac output data measured by echocardiography is defined in the device, k 15 Determination of the coefficient and subsequent kx Da data from main cardiac output measurements Continuing to measure by multiplication, - Advancing the catheter tip from the arterial space to the proximal aorta results in heart damage. the flow rate can be determined directly by measuring Da without needing the k coefficient It includes the steps of the process. 20 9. The method is based on any of claims 6-8, and its characteristic is: - intra-arterial blood pressure (KBa) measured by the blood pressure measurement sensor (3) and Arterial vascular resistance value is determined using arterial blood flow (Da); VRa = Calculation according to the KBa / Da relationship, 25 - Arterial cross-sectional surface area (A1), blood flow velocity (Va), intra-arterial blood pressure (KBa), arterial blood volume (Ha), arterial blood flow rate (Da), fluid responsiveness The parameter and at least one of the arterial vascular resistance values ​​must be in the data communication unit. (5) transfer of the transferred data via a monitor, smartphone and / or Display on tablet 30 It includes the steps of the process.

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