Body position hypotension real-time monitoring system

Abstract

The invention discloses a postural hypotension real-time monitoring system, and belongs to the field of medical instruments. The monitoring system comprises a sensing module composed of three pressure sensors, the three pressure sensors are located on the endocardium of the right ventricle, the endocardium of the right atrium and the inferior vena cava respectively, pressure signals of the three positions are transmitted to a signal processing module, the signal processing module judges signal changes, meanwhile, the signals are transmitted to a communication module, and the communication module is connected with the communication module. And the communication module transmits the pressure signal to external equipment. The signal processing module sends an instruction to the stimulation module after judging the situation needing intervention, and the pulse generator sends pulses to the electrode, so that the electrode stimulates cardiac contraction. According to the invention, the pressure change of the human body caused by the change of the body position can be more comprehensively evaluated, so that danger stratification, early recognition and intervention can be more easily carried out, reasonable clinical treatment can be guided, and the patient and related medical personnel can conveniently monitor the blood pressure condition of the patient in real time.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and specifically relates to a real-time monitoring system for postural hypotension, which can accurately determine the spatiotemporal dynamic changes of pressure distribution inside the cardiovascular system, monitor postural hypotension in real time, and provide real-time electrical stimulation in coordination with an electrical stimulation module. Background Art

[0002] Postural hypotension, also known as orthostatic hypotension, is a common clinical disease in people of all ages, especially in the elderly. According to statistics, the incidence of postural hypotension in the elderly over 65 years old is as high as 20%. The core pathophysiological feature of this disease is that the autonomic nervous system responsible for regulating vasoconstriction weakens or even loses its ability to respond when the patient changes from a supine position to a standing position, resulting in a significant decrease in venous return. This change causes a sudden drop in the pressure of the right heart cavity and the inferior vena cava, which in turn causes a sharp drop in the effective amount of blood pumped by the heart, inducing a series of clinical symptoms, such as dizziness, and even syncope in severe cases. It is worth noting that although the clinical symptoms of postural hypotension of different severities are diverse, they all first manifest as significant fluctuations in cardiovascular pressure. Dynamic and continuous monitoring of cardiovascular pressure is undoubtedly of great value for disease risk stratification, early symptom identification and intervention, and guidance of precise clinical treatment in patients with orthostatic hypotension.

[0003] The current implantable devices used for intra-cardiovascular pressure monitoring mainly serve temporary hemodynamic assessments rather than continuous, real-time monitoring of the pressure status of the cardiovascular system. The limitation of such devices is that they can only obtain pressure readings from a single monitoring point, and these isolated absolute pressure values ​​cannot fully depict the overall picture of intra-cardiovascular pressure, especially the lack of insight into the overall pressure distribution and dynamic changes. In addition, since the data from a single monitoring point is easily affected by the patient's daily activities, behaviors such as position changes and limb movements may cause fluctuations in pressure readings, thereby interfering with the accuracy of the monitoring results. In practical applications, this limitation may cause transient pressure changes caused by daily activities to be misjudged as pathological phenomena, or pressure changes that are truly related to orthostatic hypotension to be ignored due to incomplete data monitoring.

[0004] At the same time, existing related monitoring devices cannot make timely intervention and treatment when postural hypotension occurs. As a widely used treatment device for arrhythmias, pacemakers can intervene in cardiac activity, but they cannot monitor the pressure signals in the heart chambers.

[0005] In summary, although existing cardiovascular pressure monitoring devices have clinical value in specific circumstances, they have obvious limitations for patients with orthostatic hypotension. They are difficult to meet the needs of real-time, comprehensive monitoring that is not interfered with by daily activities, and limit their ability to accurately capture and judge orthostatic hypotension events that occur in a short period of time. Therefore, they are not suitable as an effective tool for long-term and accurate monitoring of cardiovascular pressure in such patients, and they are unable to intervene when orthostatic hypotension occurs to prevent serious consequences. Summary of the invention

[0006] In view of the above-mentioned deficiencies or shortcomings, a new generation of device is provided to realize continuous, multi-point and dynamic monitoring and treatment of cardiovascular pressure. The present invention provides a real-time monitoring system for orthostatic hypotension.

[0007] A real-time monitoring system for postural hypotension, comprising a sensor module, a stimulation module, a signal processing module and a communication module;

[0008] The sensing module includes three pressure sensors, namely a first pressure sensor fixed on the endocardium of the right ventricle, a second pressure sensor fixed on the endocardium of the right atrium, and a third pressure sensor fixed in the cavity of the inferior vena cava. Each pressure sensor continuously transmits the detected pressure signal to the signal processing module.

[0009] The endocardial pressure sensor is fixed by biological glue or a physical fixing unit; the physical fixing unit is a micro claw or a micro button; the intravascular pressure sensor is fixed by a ring bayonet.

[0010] The sensing elements used in pressure sensors are piezoelectric materials or triboelectric materials, both of which are flexible materials.

[0011] The signal processing module determines the overall pressure change information based on the pressure signals transmitted by each pressure sensor, and sends the pressure signals and the overall pressure change information transmitted by each pressure sensor to an external terminal device by wireless transmission through the communication module; at the same time, a judgment is made on the pressure signal and the overall pressure change information to determine whether intervention is required.

[0012] The stimulation module consists of electrodes and a pulse generator, which are connected by wires. The pulse generator uses the pulse generator of a pacemaker device. The electrode is located in the right ventricle, the same as the electrode position of a traditional pacemaker. The module is connected to the signal processing module and is controlled by it. When the signal processing module determines that intervention is needed based on the processing results, the signal processing module issues instructions to the stimulation module to control the pulse generator to generate pulses. After the pulse signal reaches the electrode, it directly stimulates the heart to contract.

[0013] The external device gives feedback based on the received pressure signal and pressure change information, and adjusts the system parameters through the communication module, thereby regulating the overall operation and parameter settings of the system.

[0014] The working process of the real-time monitoring system for postural hypotension is:

[0015] First, normal pressure range data is obtained; the normal pressure range data includes a first normal pressure range, a second normal pressure range and a third normal pressure range; the first normal pressure range, the second normal pressure range and the third normal pressure range refer to normal pressure ranges of the right ventricle, the right atrium and the inferior vena cava respectively;

[0016] Then, the current severity level of the disease is determined based on the normal pressure range data and the first pressure signal, the second pressure signal and the third pressure signal monitored in real time. The current severity level of the disease is used to reflect the severity of orthostatic hypotension, and the intervention measures of the signal processing module and the stimulation module are determined based on the severity.

[0017] The severity is related to the pressure drop range and the pressure drop position obtained by the pressure sensor. When a person transitions from a lying position to a standing position, if the autonomic nervous system's ability to regulate vasoconstriction is weakened or even disappears, the return blood flow will decrease. At this time, the second pressure sensor and the third pressure sensor detect the pressure drop. Combined with the data of the first pressure sensor at this time, the intervention measures taken by the signal processing module are as follows:

[0018] (1) If the first pressure sensor does not detect a pressure drop, a low-intensity intervention measure is given, and the signal processing module sends a low-intensity intervention signal to the stimulation module;

[0019] (2) When the first pressure sensor detects a pressure drop, a high-intensity intervention measure is taken, and the signal processing module sends a high-intensity intervention signal to the stimulation module.

[0020] The advantages of the real-time diagnosis and treatment system for postural hypotension of the present invention are:

[0021] (1) The functional material with force-electricity conversion effect is applied to the pressure sensor. The force conditions at different positions are reflected through the output electrical signals by using the characteristics of the functional material with force-electricity conversion effect. The output electrical signals are processed to obtain the pressure magnitude and range at three different positions.

[0022] (2) The system can classify the severity of the patient's disease by comparing the measured normal pressure range with the real-time measurement data, providing data support for subsequent diagnosis by medical staff;

[0023] (3) The functional materials used can convert this piezoelectricity into an electrical signal and output it outside the body through a signal transmission module. The signal can be used to monitor the blood pressure in the heart cavity in real time. At the same time, the pressure data collected based on the three sites can help to more comprehensively evaluate the pressure changes caused by changes in body position in patients with orthostatic hypotension, which in turn can help to conduct risk stratification, early identification and intervention, and guide reasonable clinical treatment, so that the patient himself and relevant medical staff can monitor the patient's blood pressure in real time and promptly discover and seek medical treatment when abnormal blood pressure occurs.

[0024] (4) The present invention realizes the integration of pressure detection and treatment, and can timely intervene in cardiac contraction and other functions when severe hypotension occurs, ensuring that patients receive timely treatment and preventing serious consequences. It is of urgent necessity and important value for improving the diagnostic accuracy and treatment refinement of orthostatic hypotension. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a structural schematic diagram of the real-time monitoring system for postural hypotension of the present invention;

[0026] Figure 2 The position diagram of each module of the real-time monitoring system for postural hypotension of the present invention is

[0027] Figure 3 This is a flow chart of the operation of the real-time monitoring system for postural hypotension of the present invention.

[0028] In the figure:

[0029] 11-pressure sensing module, 12-signal processing module, 13-communication module, 14-electrical stimulation module;

[0030] 21 - first pressure sensor, 22 - second pressure sensor, 23 - third pressure sensor, 24 - electrode. DETAILED DESCRIPTION

[0031] The present invention will be further described in detail below with reference to the accompanying drawings and embodiments.

[0032] The present invention provides a real-time monitoring system for postural hypotension, which mainly includes a three-point pressure monitoring device in the cardiovascular system and a stimulation system controlled by data processing. The device monitors the blood pressure in the heart and intervenes through electrical stimulation when abnormal signals appear.

[0033] The structure of the monitoring system is as follows Figure 1 As shown, it includes a pressure sensing module 11, a signal processing module 12, a communication module 13 and an electrical stimulation module 14.

[0034] The pressure sensing module 11 is mainly composed of three pressure sensor units, which are fixed at three positions in the cardiovascular system. Figure 2 As shown, they are fixed in the endocardium of the right ventricle, the endocardium of the right atrium, and the cavity of the inferior vena cava, respectively. For the convenience of distinction, the pressure sensor fixed in the endocardium of the right ventricle can be called the first pressure sensor 21, the pressure sensor fixed in the endocardium of the right atrium can be called the second pressure sensor 22, and the pressure sensor fixed in the cavity of the inferior vena cava can be called the third pressure sensor 23. The three pressure sensors simultaneously collect pressure data of the three regions in the cardiovascular system, and each pressure sensor is used to continuously transmit the detected pressure signal to the signal processing module 12.

[0035] The principle of the pressure sensor unit used in the pressure sensing module can be piezoelectric, triboelectric, capacitive or piezoresistive, etc. The sensing element used in the present invention preferably uses piezoelectric material or triboelectric material, and both are flexible materials. The softness and bendability of the pressure sensor made of flexible materials enable it to better adapt to the shape of the heart or blood vessels, which can reduce the discomfort of the patient after implantation in the patient's cardiovascular system and improve the patient's acceptance and comfort.

[0036] The signal processing module 12 is connected to the pressure sensing module 11, the communication module 13 and the electrical stimulation module 14. The signal processing module receives the electrical signal from the pressure sensing module 11, obtains the pressure information of each point after processing, and transmits the information to the communication module 13 and then to the external device, which can be used to monitor the blood pressure information of various positions of the heart in real time. In addition, when a preset abnormal signal appears, the signal processing module will issue an instruction to the electrical stimulation module 14, start the electrical stimulation module 14, and control the pulse generator in the electrical stimulation module to emit an electrical signal.

[0037] The communication module 13 is connected to the signal processing module 12, and is connected to an external device through a wireless method such as Bluetooth to achieve mutual transmission of signals; the information collected by the system can be transmitted to an external device such as a mobile phone through this module, and the external device visualizes the pressure data and overall pressure change information fed back by the signal processing and communication module, and the pressure information of each point can be monitored and viewed in real time through the external device, so that doctors and patients can intuitively understand the real-time pressure situation in the patient's cardiovascular system. At the same time, the system parameters can be adjusted through external devices such as mobile phones to regulate the overall operation and parameter settings of the system.

[0038] The electrical stimulation module 14 includes a pulse generator and a stimulation electrode 24, which are connected by a wire. When the module receives an instruction from the signal processing module 12, the pulse generator will generate a pulse signal of a certain frequency and size according to the instruction. The signal is transmitted to the stimulation electrode 24 through the wire, and finally stimulates the heart to contract.

[0039] The specific working mode of the system is as follows Figure 3 As shown, specifically:

[0040] First, the normal pressure ranges of three points under normal conditions can be acquired through the pressure sensing module, including the first normal pressure range, the second normal pressure range and the third normal pressure range; the first normal pressure range, the second normal pressure range and the third normal pressure range refer to the normal pressure ranges of the right ventricle, the right atrium and the inferior vena cava respectively;

[0041] Then, by comparing the real-time pressure data, the current severity level of the disease is determined according to the normal pressure range data and the first pressure signal, the second pressure signal and the third pressure signal. The current severity level of the disease is used to reflect the severity of orthostatic hypotension, and intervention measures are taken according to the severity.

[0042] The severity is mainly related to the pressure drop range and pressure drop position obtained by the pressure sensor, and is adjusted according to the actual situation and patient condition.

[0043] Under normal circumstances, the pressure in the inferior vena cava of the human body is about 3-9 mmHg, the pressure in the right atrium is about 5-10 mmHg, and the pressure in the right ventricle is about 15-20 mmHg. There is a certain pressure gradient ratio between the three. Blood returns from the blood vessels throughout the body to the inferior vena cava, then to the right atrium and right ventricle, and is pumped into the pulmonary circulation by the right ventricle.

[0044] When someone transitions from a lying position to a standing position, the autonomic nervous system's ability to regulate vasoconstriction is significantly weakened or even disappears, resulting in a significant drop in venous return. In this context, the pressure drop detected by the second and third pressure sensors is a clear signal of insufficient venous return, indicating that the patient is at risk of hypotension. At this time, the signal processing module combines the data from the first pressure sensor to make intervention measures:

[0045] (1) If the first pressure sensor does not detect a pressure drop, low-intensity intervention measures are given to improve atrial filling, compensate for the impact of reduced venous return, and appropriately increase cardiac output to prevent the occurrence of hypotension events;

[0046] (2) If the first pressure sensor detects a drop in pressure, indicating that the patient is about to experience a hypotensive event, high-intensity intervention measures are given to further improve ventricular filling and contraction to prevent the occurrence of a hypotensive event.

[0047] Afterwards, the acquired pressure signal and overall pressure change information are sent to the external device in real time by wireless transmission. The external terminal device analyzes the existing data and adjusts the parameters of the implanted device as needed. And when a more serious pressure signal abnormality occurs, the signal processing module controls the stimulation module to generate electrical stimulation to intervene in the heart activity, ensure the heart's blood output, and prevent serious consequences.

Claims

1. A real-time monitoring system for postural hypotension, characterized in that: It includes a sensing module, a stimulation module, a signal processing module and a communication module; The sensing module includes three pressure sensors, namely a first pressure sensor fixed on the endocardium of the right ventricle, a second pressure sensor fixed on the endocardium of the right atrium, and a third pressure sensor fixed in the cavity of the inferior vena cava, each of which continuously transmits a detected pressure signal to the signal processing module; The signal processing module determines the overall pressure change information according to the pressure signals transmitted by each pressure sensor, and sends the pressure signals and the overall pressure change information transmitted by each pressure sensor to the external terminal device by wireless transmission through the communication module; at the same time, the signal processing module makes a judgment on the pressure signal and the overall pressure change information to determine whether intervention is required; The stimulation module consists of electrodes and a pulse generator, which are connected by wires. The pulse generator uses the pulse generator of a pacemaker device, and the electrode is located in the right ventricle. The module is connected to the signal processing module. When the signal processing module determines that intervention is needed, the signal processing module sends an instruction to the stimulation module to control the pulse generator to generate a pulse. After the pulse signal reaches the electrode, it directly stimulates the heart to contract.

2. A real-time monitoring system for postural hypotension according to claim 1, characterized in that: The endocardial pressure sensor is fixed by biological glue or a physical fixing unit, and the intravascular pressure sensor is fixed by a ring bayonet.

3. A real-time monitoring system for postural hypotension according to claim 1 or 2, characterized in that: The sensing elements used in pressure sensors are piezoelectric materials or triboelectric materials, both of which are flexible materials.

4. A real-time monitoring system for postural hypotension according to claim 1, characterized in that: The external device gives feedback based on the received pressure signal and pressure change information, and adjusts the system parameters through the communication module, thereby regulating the overall operation and parameter settings of the system.

5. A working process of a real-time monitoring system for postural hypotension, characterized in that: Specifically: First, normal pressure range data is obtained; the normal pressure range data includes a first normal pressure range, a second normal pressure range and a third normal pressure range; the first normal pressure range, the second normal pressure range and the third normal pressure range refer to normal pressure ranges of the right ventricle, the right atrium and the inferior vena cava respectively; Then, the current severity level of the disease is determined based on the normal pressure range data and the first pressure signal, the second pressure signal and the third pressure signal monitored in real time. The current severity level of the disease is used to reflect the severity of orthostatic hypotension, and the intervention measures of the signal processing module and the stimulation module are determined based on the severity.

6. The working process of a real-time monitoring system for postural hypotension according to claim 5 is characterized in that: The severity is related to the pressure drop range and the pressure drop position obtained by the pressure sensor. When a person transitions from a lying position to a standing position, if the autonomic nervous system's ability to regulate vasoconstriction is weakened or even disappears, the return blood flow will decrease. At this time, the second pressure sensor and the third pressure sensor detect the pressure drop. Combined with the data of the first pressure sensor at this time, the intervention measures taken by the signal processing module are as follows: (1) If the first pressure sensor does not detect a pressure drop, a low-intensity intervention measure is given, and the signal processing module sends a low-intensity intervention signal to the stimulation module; (2) When the first pressure sensor detects a pressure drop, a high-intensity intervention measure is taken, and the signal processing module sends a high-intensity intervention signal to the stimulation module.

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