Pulmonary artery floating catheter based on FBG sensing technology

Abstract

The pulmonary artery floating catheter based on the FBG sensing technology comprises a balloon, a catheter body, an adapter port and an adapter tube, an inflation hole is formed in one end of the catheter body, the balloon is bonded to one end of the catheter body and wraps the inflation hole, the adapter port is connected to the other end of the catheter body, and the adapter tube is connected to the other end of the catheter body. The catheter main body is provided with an adapter port, the adapter port is connected with an adapter tube interface, the adapter tube interface is connected with at least one FBG joint, a temperature sensor joint, a near-end hole joint, a far-end hole joint and an inflation injector, the number of the FBG joints is at least one, and the FBG joints are located at different positions; the cavities comprise the first cavity, the second cavity, the third cavity, the fourth cavity and the FBG cavity, the pressure is measured by adopting the FBG sensing technology, real-time monitoring can be achieved, and data are accurate. Meanwhile, parts, assembly and finished products of the device can be finished in China, localization is achieved, the device is not limited by foreign suppliers, and the purchase cost can be effectively reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, relates to hemodynamic detection equipment, and specifically relates to a pulmonary artery flotation catheter based on FBG sensing technology. Background Technique

[0002] Pulmonary hypertension refers to a hemodynamic and pathophysiological state in which the pulmonary artery pressure rises above a certain threshold, which can lead to right heart failure. It can be an independent disease, a complication, or a syndrome, and has gradually become a cardiovascular disease that has attracted much attention, with a very high late-stage fatality rate. In 1970, the pulmonary artery flotation catheter (also known as the SWAN-GANZ catheter or PC catheter) began to be used clinically. It can measure the pulmonary artery pressure and pulmonary capillary wedge pressure, and at the same time can monitor the pressure and its subtle changes at some specific sites in the cardiovascular system. By monitoring these physiological indicators, the real-time pulmonary artery pressure of the patient can be measured, and the cardiovascular function status of the patient can be judged.

[0003] The pulmonary artery flotation catheter has three advantages: fewer ventricular arrhythmias, can be quickly inserted into the pulmonary artery, and does not require X-ray fluoroscopy. It has currently become the clinical standard for detecting pulmonary artery pressure. The flotation catheter is inserted through puncture of the cubital vein, femoral vein, internal jugular vein, or subclavian vein, and then enters the right atrium and right ventricle through the superior or inferior vena cava, and reaches the pulmonary artery through the guidance of the head gas balloon, so as to measure the pulmonary artery pressure and pulmonary capillary wedge pressure.

[0004] In existing pulmonary artery flotation catheter products, there are mainly two pressure measurement methods. One is to directly measure using a pressure sensor, but the price is relatively expensive; the other is to draw blood from different sites out of the body and then measure the pressure through a pressure measurement device. This method has a pressure difference problem, and there will be a certain deviation in the measured pressure data. Moreover, most pulmonary artery flotation catheter products are purchased abroad, with a relatively high price and difficult sources. The existing pulmonary artery flotation catheter products can no longer meet the increasing clinical needs.

[0005] FBG was first applied by NASA to the strain measurement of aerospace structures. It entered the stage of mature application around 2000. Its full name is Fiber Bragg Grating, that is, an optical fiber Bragg grating, which is a grating with a periodic spatial phase distribution formed in the core. The essence of its function is to form a narrow-band (transmission or reflection) filter or mirror in the core. When the temperature and stress states in the FBG area change, the Bragg wavelength changes accordingly in real time. The temperature measurement accuracy of FBG can reach 0.1K, and the strain measurement accuracy can reach 1 microstrain. The sampling rate ranges from a few Hz to a few kHz, and basically can achieve real-time data transmission. There can be multiple FBG gratings on one optical fiber, each working independently with its Bragg wavelength as a marker, forming a serial sensor, that is, one optical fiber completes signal transmission, sensing, signal reading, wiring and maintenance are simple, and it is suitable for multi-point temperature and strain measurement in space-constrained areas.

[0006] Most of the current mainstream pulmonary artery flotation catheters come from Edwards Company in the United States. There are 1 - 6 cavity openings at the top of the pulmonary artery flotation catheter, so there are types of double-cavity to seven-cavity balloon flotation catheters. The most commonly used products currently are five-cavity balloon flotation catheters and six-cavity balloon flotation catheters. As Figure 1 shown, there is an opening at the top of the flotation catheter connected to the distal pulmonary artery port, which is used for pressure detection or injection and aspiration. There is also a sensor at the top. There is a balloon around 1 mm from the tip of the flotation catheter, which is used to make the catheter "float" when inflated. There is another opening 30 cm from the tip connected to the proximal infusion port. There is a 11-cm-long thermal expansion coil at 14 cm from the tip for measuring CCO through temperature. In addition, there are markings at every 10-cm increment from the tip, which are used to assist catheter insertion.

[0007] There are six ports at the end of the catheter, which are used to connect various other devices, including:

[0008] ① Balloon inflation port

[0009] ② Distal pulmonary artery port

[0010] ③ Optical module connection port

[0011] ④ Proximal infusion port

[0012] ⑤ and ⑥ Thermistor connection port and hot wire connection port.

[0013] This flotation catheter (Swan-Ganz) is widely used in hospital clinics, mainly used to monitor pulmonary artery pressure and hemodynamic parameters to judge the cardiovascular function status of patients.

[0014] In the prior art, measuring pressure with a pulmonary artery flotation catheter requires drawing blood from different sites outside the body and then measuring the pressure through a pressure measuring device. This method has problems with pressure differences, the data will lag, and there will be certain deviations in the measured pressure data.

[0015] Most of the flotation catheter products are purchased from abroad. Restricted by foreign suppliers, they are expensive and difficult to obtain. The accuracy of domestic pressure sensors fails to meet clinical requirements, and the quantity of products cannot meet the growing clinical needs.

[0016] To solve the problems of pressure difference, difficult access, and high price of the pulmonary artery flotation catheter, this application intends to apply the FBG optical fiber sensing technology to the pressure measurement of the flotation catheter, and provide a domestic pulmonary artery flotation catheter, specifically a pulmonary artery flotation catheter based on the FBG sensing technology. Summary of the Invention

[0017] To solve the above technical problems, the present invention proposes a pulmonary artery flotation catheter based on the FBG sensing technology. Measuring pressure using the FBG sensing technology can achieve real-time monitoring with accurate data. At the same time, the parts, assembly, and finished products of this device can all be completed domestically, achieving localization, not being restricted by foreign suppliers, and being able to effectively reduce the procurement cost.

[0018] To achieve the above object, the technical solution adopted by the present invention is:

[0019] A pulmonary artery flotation catheter based on FBG sensing technology, characterized in that: it includes a balloon, a catheter body, a transfer port and a transfer tube. The catheter body is of a hollow structure and has an inflation hole provided at one end thereof. The balloon is adhered to one end of the catheter body and is arranged to wrap the inflation hole. The transfer port is connected to the other end of the catheter body. A transfer tube interface is connected to the transfer port. An FBG connector, a temperature sensor connector, a proximal hole connector, a distal hole connector and an inflation syringe are connected to the transfer tube interface. At least one FBG connector is provided and is located at different positions. A cavity is sequentially arranged along the axial direction in the catheter body. The cavity includes a first cavity, a second cavity, a third cavity, a fourth cavity and an FBG cavity. One end of the first cavity is a proximal hole, and the other end is connected to the proximal hole connector through a transfer tube. The second cavity connects the inflation hole and the inflation syringe. One end of the third cavity is a distal hole, and the other end is connected to the distal hole connector through a transfer tube. A temperature sensor is adhered in the fourth cavity, and the sensing head of the temperature sensor is located at the front end opening of the fourth cavity. The connecting wire of the temperature sensor is connected to the temperature sensor connector. An FBG optical fiber is adhered in the FBG cavity. A hole is opened at the front end of the FBG cavity to expose at least one grating area on the FBG optical fiber. The tail end of the FBG cavity is connected to the FBG connector. When the pulmonary artery flotation catheter is delivered to the measurement point, the temperature sensor at the front end of the catheter body can detect the blood temperature at the measurement point. At least one FBG optical fiber located at different positions at the front end of the catheter body can detect the coupling value of temperature and pressure at the measurement point and is transmitted to the device through the FBG connector. After obtaining the measurement value, the HHO-KELM model in the device is used for decoupling, and the real-time pressure value here can be obtained.

[0020] In the above structure: The present invention proposes a pulmonary artery floating catheter based on FBG sensing technology. By using FBG sensing technology to measure pressure, real-time monitoring can be achieved with accurate data. At the same time, the parts, assembly, and finished products in this application can all be completed domestically, realizing localization, being unrestricted by foreign suppliers, and being able to effectively reduce procurement costs. The specific technical solution is as follows: It includes a balloon, a catheter body, a transfer port, and a transfer tube. Among them, the catheter body is a hollow structure and an inflation hole is provided at one end thereof. The balloon is bonded to one end of the catheter body and is arranged to wrap the inflation hole. The transfer port is connected to the other end of the catheter body, and a transfer tube interface is connected to the transfer port. An FBG connector, a temperature sensor connector, a proximal hole connector, a distal hole connector, and an inflation syringe are connected to the transfer tube interface. Among them, at least one FBG connector is provided and is located at different positions. Cavities are sequentially arranged along the axial direction of the catheter body. The cavities include a first cavity, a second cavity, a third cavity, a fourth cavity, and an FBG cavity. The installation and realization of the FBG connector, temperature sensor connector, proximal hole connector, distal hole connector, and inflation syringe are achieved through the provided cavities. Among them, one end of the first cavity is a proximal hole, and the other end is connected to the proximal hole connector through a transfer tube. The proximal hole connector can be connected to a syringe, etc., to infuse a specific part, or can also infuse ice water to measure cardiac output by the thermodilution method. The second cavity connects the inflation hole and the inflation syringe. One end of the third cavity is a distal hole, and the other end is connected to the distal hole connector through a transfer tube. The distal hole connector can be connected to a syringe, etc., to infuse the distal part. A temperature sensor is bonded in the fourth cavity, and the sensing head of the temperature sensor is located at the front opening of the fourth cavity to facilitate measuring the temperature at the measurement point. The connection line of the temperature sensor is connected to the temperature sensor connector to realize the transmission of temperature sensor data. This application uses FBG sensing technology for pressure measurement. Since the data measured by the FBG optical fiber is a coupled value of temperature and pressure, a temperature sensor is added for temperature measurement. After obtaining the temperature value, the HHO-KELM model is used to decouple the FBG optical fiber data to obtain an accurate pressure value. Considering that the floating catheter moves in the blood vessel and may stick to the blood vessel wall, 2 FBG optical fibers are selected for simultaneous measurement, which can ensure that at least one FBG optical fiber can detect the real pressure of the blood.

[0021] During use, the pulmonary artery floating catheter is transported to the measurement point. The temperature sensor at the front end of the catheter body can detect the blood temperature at the measurement point, and the FBG optical fiber at the front end of the catheter body can detect the coupling value of temperature and pressure at the measurement point. Considering that the floating catheter moves in human blood and may adhere to the blood vessel wall, two FBG optical fibers at different positions are selected for measurement together, which can ensure that at least one FBG optical fiber can detect the true blood pressure. After obtaining the measurement value, the HHO-KELM model is used for decoupling, and the real-time pressure value here can be obtained. The present invention breaks through the limitations of foreign floating catheters, innovatively uses FBG optical fibers for pressure measurement, with real-time and accurate data and low cost, realizing localization.

[0022] As a preferred technical solution of the present invention: there are two FBG cavities, namely the fifth cavity and the sixth cavity, the fifth cavity and the sixth cavity are arranged in a staggered manner, one FBG optical fiber is bonded in each of the fifth cavity and the sixth cavity, holes are respectively opened at the front ends of the fifth and sixth cavities to expose at least one grating area on the FBG optical fiber, and the tail ends of the fifth cavity and the sixth cavity are respectively connected to the FBG connector.

[0023] In the above structure: there are two FBG cavities, namely the fifth cavity and the sixth cavity, the fifth cavity and the sixth cavity are arranged in a staggered manner, which is convenient for the FBG optical fibers installed therein to be at different positions. Holes are respectively opened at the front ends of the fifth and sixth cavities to expose at least one grating area on the FBG optical fiber, which is convenient for the FBG optical fiber at the front end of the catheter body to detect the coupling value of temperature and pressure at the measurement point during measurement. The tail ends of the fifth cavity and the sixth cavity are respectively connected to the FBG connector, which is convenient for transporting the coupling value of temperature and pressure measured by the FBG optical fiber to the device.

[0024] As a preferred technical solution of the present invention: there are two FBG connectors, namely the FBG1 connector and the FBG2 connector, and the tail ends of the fifth cavity and the sixth cavity are respectively connected to the FBG1 connector and the FBG2 connector.

[0025] In the above structure: there are two FBG connectors, namely the FBG1 connector and the FBG2 connector, and the two FBG connectors are at different positions. Two FBG optical fibers at different positions are selected for measurement together, which can ensure that at least one FBG optical fiber can detect the true blood pressure.

[0026] As a preferred technical solution of the present invention: it further includes a hollow tube, one end of the hollow tube is respectively connected to the adapter tube, and the FBG connector, the temperature sensor connector, the proximal hole connector, the distal hole connector and the inflation syringe are respectively connected to the other end of the hollow tube.

[0027] In the above structure: The hollow tube is connected to the adapter tube. The FBG connector, temperature sensor connector, proximal hole connector, distal hole connector, and inflation syringe are respectively connected to the adapter tube through the hollow tube to achieve connection.

[0028] As a preferred technical solution of the present invention: The catheter body is provided with a fiber optic glue injection hole for installing the FBG optical fiber, an inflation hole, and a temperature sensor glue injection hole for installing the temperature sensor. The fiber optic glue injection hole communicates with the FBG cavity, the inflation hole communicates with the second cavity, and the temperature sensor glue injection hole communicates with the fourth cavity. After the FBG optical fiber and the temperature sensor are installed through the fiber optic glue injection hole and the temperature sensor glue injection hole, they are bonded with a biocompatible glue and the gaps are filled.

[0029] In the above structure: The catheter body is provided with a fiber optic glue injection hole for installing the FBG optical fiber, an inflation hole, and a temperature sensor glue injection hole for installing the temperature sensor. During installation, after the FBG optical fiber and the temperature sensor are installed through the fiber optic glue injection hole and the temperature sensor glue injection hole, they are bonded with a biocompatible glue and the gaps are filled, and the excess glue is polished off.

[0030] As a preferred technical solution of the present invention: A hydrophilic coating is provided on the outer wall of the catheter body, and a scale is provided every 10 cm on the hydrophilic coating.

[0031] In the above structure: A hydrophilic coating is provided on the outer wall of the catheter body. After the catheter body enters the human body, it is convenient to move. A scale is provided every 10 cm on the hydrophilic coating, which is convenient for medical staff to observe whether the measurement point is reached.

[0032] As a preferred technical solution of the present invention: A syringe is connected to the proximal hole connector for infusing a specific part or measuring cardiac output by thermodilution with infusion of ice water.

[0033] As a preferred technical solution of the present invention: A syringe is connected to the distal hole connector for infusing at the distal end. Compared with the prior art, the beneficial effects of the present invention are:

[0034] A pulmonary artery floating catheter based on FBG sensing technology proposed by the present invention can achieve real-time monitoring and accurate data by using FBG sensing technology to measure pressure. At the same time, the parts, assembly, and finished products of this application can be completed in China, realizing localization and being not restricted by foreign suppliers.

[0035] The present invention transports a pulmonary artery flotation catheter to the measurement point. The temperature sensor at the front end of the catheter body can detect the blood temperature at the measurement point, and the FBG optical fiber at the front end of the catheter body can detect the coupling value of temperature and pressure at the measurement point. In this application, two FBG optical fibers at different positions are selected for measurement together, which can ensure that at least one FBG optical fiber can detect the true pressure of the blood. After obtaining the measurement value, the HHO-KELM model is used for decoupling, and then the real-time pressure value here can be obtained. This application breaks through the limitations of foreign flotation catheters, innovatively uses FBG optical fibers for pressure measurement, with real-time and accurate data and low cost, achieving localization.

[0036] The present invention obtains accurate pressure values by decoupling the FBG optical fiber data and temperature sensor data through an adaptive closed-loop HHO-KELM model. This model uses the temperature parameter output by the temperature sensor to perform closed-loop correction on the pressure output of the KELM model, which can effectively eliminate the errors caused by the model during signal detection. Compared with traditional methods, it greatly improves the accuracy of pressure value decoupling.

[0037] The adaptive closed-loop mechanism of the present invention enables the model to dynamically adjust the output of the pressure value according to the temperature information real-time feedback by the temperature sensor, adapt to the influence of different ambient temperature changes on pressure measurement, and improve the adaptability and stability of the model in complex environments. Description of the Drawings

[0038] Figure 1 is a schematic diagram of the overall structure of a flotation catheter in the prior art;

[0039] Figure 2 is a schematic diagram of the overall structure of the flotation catheter in the present invention;

[0040] Figure 3 is Figure 2 a partial enlarged view of part A in

[0041] Figure 4 is Figure 2 a side view of the partial enlarged view of part A in

[0042] Figure 5 is Figure 2 a cross-sectional view of part B in

[0043] Figure 6 is Figure 2 a cross-sectional view of part C in

[0044] Figure 7 is Figure 2 a partial enlarged view of the FBG optical fiber in

[0045] Figure 8 is the flow chart of the optimized parameters of the present invention

[0046] List of reference numerals:

[0047] 1. Balloon; 2. Catheter body; 21. First cavity; 22. Second cavity; 23. Third cavity; 24. Fourth cavity; 25. Fifth cavity; 26. Sixth cavity; 3. Adapter port; 31. Temperature sensor; 32. FBG optical fiber; 33. FBG optical fiber grating region; 34. FBG optical fiber matrix; 4. Adapter tube; 5. FBG1 connector; 6. FBG2 connector; 7. Temperature sensor connector; 8. Proximal hole connector; 9. Distal hole connector; 10. Inflation syringe; 11. Proximal hole; 12. Distal hole; 13. Optical fiber glue injection hole; 14. Inflation hole; 15. Temperature sensor glue injection hole. Detailed implementation manners

[0048] The present invention will be further described in detail below in conjunction with the accompanying drawings and specific implementation manners:

[0049] As Figure 2-7As shown in the figure, the present invention provides a pulmonary artery floating catheter based on FBG sensing technology, which includes a balloon 1, a catheter body 2, a transfer port 3 and a transfer tube 4. The catheter body 2 is of a hollow structure and has an inflation hole 14 provided at one end thereof. The balloon 1 is adhered to one end of the catheter body 2 and is arranged to wrap the inflation hole 14. The transfer port 3 is connected to the other end of the catheter body 2, and a transfer tube 4 interface is connected to the transfer port 3. An FBG connector, a temperature sensor connector 7, a proximal hole connector 8, a distal hole connector 9 and an inflation syringe 10 are connected to the transfer tube 4 interface. At least one FBG connector is provided and is located at different positions. A cavity is sequentially arranged along the axial direction of the catheter body 2. The cavity includes a first cavity 21, a second cavity 22, a third cavity 23, a fourth cavity 24 and an FBG cavity. One end of the first cavity 21 is a proximal hole 11, and the other end is connected to the proximal hole connector 8 through the transfer tube 4. The second cavity 22 connects the inflation hole 14 and the inflation syringe 10. One end of the third cavity 23 is a distal hole 12, and the other end is connected to the distal hole connector 9 through the transfer tube 4. A temperature sensor 31 is adhered in the fourth cavity 24, and the sensing head of the temperature sensor 31 is located at the front end opening of the fourth cavity 24. The connecting wire of the temperature sensor 31 is connected to the temperature sensor connector 7. An FBG optical fiber 32 is adhered in the FBG cavity. A hole is opened at the front end of the FBG cavity to expose at least one grating area on the FBG optical fiber 32. The tail end of the FBG cavity is connected to the FBG connector. When the pulmonary artery floating catheter is delivered to the measurement point, the temperature sensor 31 at the front end of the catheter body 2 can detect the blood temperature at the measurement point. At least one FBG optical fiber 32 located at different positions at the front end of the catheter body 2 can detect the coupling value of temperature and pressure at the measurement point, and is transmitted to the device through the FBG connector. After obtaining the measurement value, the HHO-KELM model in the device is used for decoupling, and the real-time pressure value here can be obtained.

[0050] The present invention provides a pulmonary artery floating catheter based on FBG sensing technology. By using FBG sensing technology to measure pressure, real-time monitoring can be achieved with accurate data. At the same time, the parts, assembly, and finished products in this application can all be completed domestically, realizing localization, being not restricted by foreign suppliers, and being able to effectively reduce procurement costs. The specific technical solution is as follows: It includes a balloon 1, a catheter body 2, a transfer port 3, and a transfer tube 4. Among them, the catheter body 2 is of a hollow structure and an inflation hole 14 is provided at one end thereof. The balloon 1 is bonded to one end of the catheter body 2 and is arranged to wrap the inflation hole 14. The transfer port 3 is connected to the other end of the catheter body 2, and a transfer tube 4 interface is connected to the transfer port 3. An FBG connector, a temperature sensor connector 7, a proximal hole connector 8, a distal hole connector 9, and an inflation syringe 10 are connected to the transfer tube 4 interface. Among them, at least one FBG connector is provided and is located at different positions. Cavities are sequentially arranged along the axial direction of the catheter body 2. The cavities include a first cavity 21, a second cavity 22, a third cavity 23, a fourth cavity 24, and an FBG cavity. The installation of the FBG connector, the temperature sensor connector 7, the proximal hole connector 8, the distal hole connector 9, and the inflation syringe 10 is realized through the provided cavities. Among them, one end of the first cavity 21 is a proximal hole 11, and the other end is connected to the proximal hole connector 8 through the transfer tube 4. The proximal hole connector can be connected to a syringe, etc., for infusing fluids into a specific part, or for infusing ice water to measure cardiac output by the thermodilution method. The second cavity 22 connects the inflation hole 14 and the inflation syringe 10. One end of the third cavity 23 is a distal hole 12, and the other end is connected to the distal hole connector 9 through the transfer tube 4. The distal hole connector 9 can be connected to a syringe, etc., for infusing fluids at the distal end. A temperature sensor 31 is bonded in the fourth cavity 24, and the sensing head of the temperature sensor 31 is located at the front end opening of the fourth cavity 24, facilitating the measurement of the temperature at the measurement point. The connection line of the temperature sensor 31 is connected to the temperature sensor connector 7 to realize the transmission of the data of the temperature sensor 31. This application uses FBG sensing technology for pressure measurement. Since the data measured by the FBG optical fiber 32 is a coupled value of temperature and pressure, a temperature sensor 31 is added for temperature measurement. After obtaining the temperature value, the data of the FBG optical fiber 32 can be decoupled to obtain an accurate pressure value. Considering that the floating catheter may move in the blood vessel and may stick to the blood vessel wall, 2 FBG optical fibers 32 are selected for simultaneous measurement, which can ensure that at least one FBG optical fiber 32 can detect the real pressure of the blood.

[0051] During use, the pulmonary artery floating catheter is delivered to the measurement point. The temperature sensor 31 at the front end of the catheter body 2 can detect the blood temperature at the measurement point, and the FBG optical fiber 32 at the front end of the catheter body 2 can detect the coupling value of temperature and pressure at the measurement point. Considering that the floating catheter moves in the human blood and may adhere to the blood vessel wall, two FBG optical fibers 32 at different positions are selected for measurement together, which can ensure that at least one FBG optical fiber 32 can detect the true blood pressure. After obtaining the measurement value, the HHO-KELM model is used for decoupling, and the real-time pressure value here can be obtained. The present invention breaks through the limitations of foreign floating catheters, innovatively uses FBG optical fibers 32 for pressure measurement, with real-time and accurate data and low cost, realizing localization.

[0052] Specific operation examples of this patent:

[0053] First, after connecting the FBG connector, temperature sensor connector 7, proximal hole connector 8, and distal hole connector 9 on the floating catheter to the device, the catheter body 2 is punctured into the internal jugular vein subcutaneously, and the floating catheter is pushed into the right atrium and right ventricle along the vein. Subsequently, the inflation syringe 10 is pressed to inject 1.5 mL of carbon dioxide into the balloon 1. The balloon 1 drives the catheter body 2 to move to the pulmonary artery. The temperature sensor 31 at the front end of the catheter body 2 can measure the blood temperature at this position, and the FBG optical fiber 32 at the front end of the catheter body 2 can measure the coupling value of blood temperature and pressure. After decoupling, the real-time and accurate value of the pulmonary artery pressure can be obtained. After recording the data, the balloon 1 is deflated using the inflation syringe 10, and then the floating catheter is slowly withdrawn.

[0054] In this embodiment: there are two FBG cavities, namely the fifth cavity 25 and the sixth cavity 26, which are arranged in a staggered manner. One FBG optical fiber 32 is bonded in each of the fifth cavity 25 and the sixth cavity 26. Holes are respectively opened at the front ends of the fifth and sixth cavities 26 to expose at least one grating area on the FBG optical fiber 32. The tails of the fifth cavity 25 and the sixth cavity 26 are respectively connected to the FBG connector.

[0055] There are two FBG cavities, namely the fifth cavity 25 and the sixth cavity 26. The fifth cavity 25 and the sixth cavity 26 are arranged in a staggered manner, facilitating the FBG optical fiber 32 installed therein to be at different positions. Holes are respectively opened at the front ends of the fifth and sixth cavities 26 to expose at least one grating area on the FBG optical fiber 32. When measuring, the FBG optical fiber 32 at the front end of the catheter body 2 can detect the coupling value of temperature and pressure at the measurement point. The tail ends of the fifth cavity 25 and the sixth cavity 26 are respectively connected to the FBG connectors, facilitating the transmission of the coupling value of temperature and pressure measured by the FBG optical fiber 32 to the device. The FBG optical fiber 32 includes an FBG optical fiber matrix 34, and FBG optical fiber grating areas 33 are separated on the FBG optical fiber matrix 34.

[0056] In this embodiment: There are two FBG connectors, namely the FBG1 connector 5 and the FBG2 connector 6. The tail ends of the fifth cavity 25 and the sixth cavity 26 are respectively connected to the FBG1 connector 5 and the FBG2 connector 6.

[0057] There are two FBG connectors, namely the FBG1 connector 5 and the FBG2 connector 6. The two FBG connectors are located at different positions. Selecting two FBG optical fibers 32 at different positions to measure together can ensure that at least one FBG optical fiber 32 can detect the true blood pressure.

[0058] In this embodiment: It further includes a hollow tube. One end of the hollow tube is respectively connected to the adapter tube 4, and the FBG connector, the temperature sensor connector 7, the proximal hole connector 8, the distal hole connector 9, and the inflation syringe 10 are respectively connected to the other end of the hollow tube.

[0059] The hollow tube is connected to the adapter tube 4. The FBG connector, the temperature sensor connector 7, the proximal hole connector 8, the distal hole connector 9, and the inflation syringe 10 are respectively connected to the adapter tube 4 through the hollow tube to achieve connection.

[0060] In this embodiment: The catheter body 2 is provided with an optical fiber glue injection hole 13 for installing the FBG optical fiber 32, an inflation hole 14, and a temperature sensor glue injection hole 15 for installing the temperature sensor 31. The optical fiber glue injection hole 13 communicates with the FBG cavity, the inflation hole 14 communicates with the second cavity 22, and the temperature sensor glue injection hole 15 communicates with the fourth cavity 24. After the FBG optical fiber 32 and the temperature sensor 31 are installed through the optical fiber glue injection hole 13 and the temperature sensor glue injection hole 15, they are bonded with a biocompatible glue and the gaps are filled.

[0061] On the catheter body 2, there are provided an optical fiber injection hole 13 for installing the FBG optical fiber 32, an inflation hole 14, and a temperature sensor injection hole 15 for installing the temperature sensor 31. During installation, after the FBG optical fiber 32 and the temperature sensor 31 are installed through the optical fiber injection hole 13 and the temperature sensor injection hole 15, they are bonded with a biocompatible glue, the gap is filled, and the excess glue is polished off.

[0062] In this embodiment: A hydrophilic coating is provided on the outer wall of the catheter body 2, and a scale is provided every 10 cm on the hydrophilic coating.

[0063] A hydrophilic coating is provided on the outer wall of the catheter body 2, which facilitates movement after the catheter body 2 enters the human body. A scale is provided every 10 cm on the hydrophilic coating, which facilitates medical staff to observe whether the measurement point is reached.

[0064] A syringe is connected to the proximal hole connector 8 for infusing a specific part or measuring cardiac output by thermodilution method using ice water infusion.

[0065] A syringe is connected to the distal hole connector 9 for infusing at the distal end.

[0066] A pulmonary artery floating catheter based on FBG sensing technology proposed by the present invention can achieve real-time monitoring and accurate data by using FBG sensing technology to measure pressure. At the same time, the parts, assembly, and finished products of this application can be completed domestically, realizing localization and being not restricted by foreign suppliers.

[0067] The present invention transports the pulmonary artery floating catheter to the measurement point. The temperature sensor 31 at the front end of the catheter body 2 can detect the blood temperature at the measurement point, and the FBG optical fiber 32 at the front end of the catheter body 2 can detect the coupling value of temperature and pressure at the measurement point. Two FBG optical fibers 32 at different positions are selected in this application for measurement, which can ensure that at least one FBG optical fiber 32 can detect the true pressure of the blood. After obtaining the measurement value, the HHO-KELM model is used for decoupling, and the real-time pressure value here can be obtained. This application breaks through the limitations of foreign floating catheters, innovatively uses FBG optical fibers 32 for pressure measurement, with real-time and accurate data and low price, realizing localization.

[0068] The specific method for decoupling the FBG optical fiber data and the temperature sensor data by using the adaptive closed-loop HHO-KELM model to obtain the accurate pressure value is as follows:

[0069] Step 1: Data acquisition and preprocessing. Use the FBG optical fiber sensor to collect signal data containing temperature and pressure information, and use the temperature sensor to collect temperature signals. Perform low-pass filtering on the collected data.

[0070] Step 2: Initialize the kernel function and initial parameters, and construct the KELM model. Use the preprocessed FBG fiber optic sensor data as the input, and temperature and pressure as the output. The pressure output of the temperature parameter closed-loop correction model output by the temperature sensor is used to eliminate the error caused by the model during the signal detection process.

[0071] Step 2.1. Kernel function selection and parameter initialization

[0072] Use the radial basis function as the kernel function of KELM, and its mathematical expression is:

[0073] K(x i ,x j )=exp(-γ||x i -x j || 2 )

[0074] Among them, K(x i ,x j ) is the radial basis kernel function, ||·|| is the Euclidean distance, x i is the i-th sample, x j is the j-th sample, γ is the kernel parameter that controls the width of the kernel function. The relationship between the kernel parameter γ and the bandwidth parameter σ can be expressed as:

[0075]

[0076] Initialize the kernel function parameters and the bandwidth parameter γ0 = 0.5, σ0 = 1.0, and the initial value of the regularization coefficient C is C0 = 100.

[0077] Step 2.2. Define the input and output data structures

[0078] The input data matrix of the KELM model is the input matrix X ∈ R N×D formed by the preprocessed FBG sensor signal data, where N is the number of samples and D is the number of sensor channels. The output data matrix of the KELM model has the target outputs of temperature and pressure values, forming the matrix Y ∈ R N×2 , with the first column being the temperature value and the second column being the pressure value.

[0079] Step 2.3. Kernel matrix calculation and model construction

[0080] Based on the training data X and the initial parameter γ0, calculate the kernel matrix Ω ∈ R N×N , and the elements of the kernel matrix are:

[0081]

[0082] Among them, Ω ijis the kernel matrix element calculated for individuals i and j. Then, according to the KELM theory, calculate the output weight matrix β ∈ R N×2 :

[0083]

[0084] where I is the identity matrix.

[0085] Step 2.4. Model Output

[0086] Define the output function of KELM as:

[0087]

[0088] where is the output of KELM, i.e., the predicted pressure and temperature

[0089] The pressure output of the closed-loop correction model of the temperature parameter output by the temperature sensor:

[0090]

[0091] where P is the final output pressure of the model, and T measure is the temperature measured by the temperature sensor.

[0092] Step 3: Use the HHO algorithm to optimize the KELM model parameters. Use the HHO algorithm to optimize the kernel function parameters and regularization coefficients of the KELM model to obtain the optimal KELM model parameters. The flowchart of the optimized parameters is as Figure 8 shown.

[0093] Step 3.1. HHO Algorithm Parameter Setting

[0094] Set the number of Harris hawk individuals M = 50, define the maximum number of iterations T max = 100, and set the escape energy threshold E0 ∈ [0, 1]. The search range of the kernel parameter γ ∈ [10 -3 , 10 3 , and the search range of the regularization coefficient C ∈ [10 -3 , 10 3

[0095] For each Harris hawk individual i, i = 1, 2, …, M, randomly generate the parameter combinations of the kernel function parameter and the regularization coefficient (γ i , C i ):

[0096] γ i = γ min +(γ max -γ min ​)·rand(0,1)

[0097] C i = C min +(C max - C min )·rand(0,1)

[0098] where γ min and γ max are the lower and upper bounds of the search for the kernel parameter γ, C min and C max are the lower and upper bounds of the search for the regularization coefficient C, and rand(0,1) is a uniformly distributed random number.

[0099] Step 3.2. Fitness function design

[0100] Take the mean square error of the KELM model on the training set samples as the fitness value to minimize the prediction error:

[0101]

[0102] where Fitness(γ, C) is the fitness function used to evaluate the quality of the parameter combination (γ, C), y k is the true temperature and pressure value, is the model prediction value, k is the sample index, and N is the number of samples. For each Harris hawk individual (γ i , C i ), recalculate the kernel matrix Ω i and the weight matrix β i according to the formula in Step 2. Use the training data itself as the input to calculate the prediction value and calculate the fitness value Fitness i of this individual.

[0103] Step 3.3. Simulation of Harris hawk hunting behavior

[0104] Step 3.3.1 Escape energy update

[0105] In each iteration t, dynamically update the escape energy E to control the algorithm to switch from global exploration to local exploitation:

[0106]

[0107] where T max is the maximum number of iterations. When |E| ≥ 1, global exploration is performed and the prey has not been found. When |E| < 1, local exploitation is performed and the prey is surrounded.

[0108] Step 3.3.2 Global exploration phase

[0109] If |E| ≥ 1, the Harris hawk randomly searches for the prey's location, and the position update formula is expressed as:

[0110]

[0111] where X(t + 1) is the parameter position of the Harris hawk at the (t + 1)-th iteration, X(t) is the parameter position of the Harris hawk at the t-th iteration, represents the parameter combination (γ, C), X rand (t) is the parameter position of a random individual in the current population at the t-th iteration, X best (t) is the position of the current optimal individual at the t-th iteration, X mean (t) is the average position of the population at the t-th iteration, r1, r2, r3, r4 are random numbers within [0, 1], q is a random probability value, and L, U are the lower and upper limits of parameter search.

[0112] Step 3.3.3 Local development stage

[0113] If |E| < 1, according to the prey escape energy E and the random number r, where the range of the random number r is 0 to 1, select the following strategies:

[0114] Set soft enclosure, r ≥ 0.5 and |E| ≥ 0.5:

[0115] X(t + 1) = X best (t) - X(t) - E|JX best (t) - X(t)|

[0116] where J = 2(1 - r5) simulates the random jump intensity of the prey, and r5 ∈ [0, 1].

[0117] Set hard enclosure, r ≥ 0.5 and |E| < 0.5:

[0118] X(t + 1) = X best (t) - E|X best (t) - X(t)|

[0119] Set progressive rapid dive, r < 0.5 and |E| ≥ 0.5, generate a random vector S ∈ R 2 , and calculate the dive position:

[0120] X temp = X best (t) - E|JX best (t) - X(t)|

[0121]

[0122] where X temp is a temporary variable, and Levy() is the Levy flight random step size.

[0123] Set a quick dive attack, where r < 0.5 and |E| < 0.5:

[0124] X(t + 1) = X best (t) - E|X best (t) - X mean (t)|

[0125] Step 3.4. Parameter optimization and model update

[0126] Stop when reaching T max or when the fitness value converges. And record the global optimal individual X best = (γ opt , C opt ).

[0127] Step 4: Model training. Use the optimized KELM model to train the training data to ensure that the model can accurately extract temperature and pressure information.

[0128] Step 4.1 Input data division. Divide the data preprocessed in Step 1 into a training set D train and a validation set D val , and make the output matrices Y train and Y val of the training set and the validation set correspond one-to-one with the input data.

[0129] Step 4.2 Model parameter loading. Obtain the kernel parameter γ opt optimized by the HHO algorithm and the regularization coefficient C opt from Step 3. Based on the training set data D train and γ opt , recalculate the kernel matrix Ω train :

[0130] Ω train = exp(-γ opt ||x i - x j || 2 )

[0131] Use the optimized C opt to solve the weight matrix β opt :

[0132]

[0133] Adopt Cholesky decomposition to ensure the numerical stability of matrix inversion. Obtain the output trained function:

[0134]

[0135] Step 5: Use the trained adaptive HHO-KELM model to predict the measurement data to obtain the decoupled values of temperature and pressure.

[0136] As described above, it is only a preferred embodiment of the present invention, and it is not a limitation of the present invention in any other form. Any modification or equivalent change made according to the technical essence of the present invention still belongs to the scope of protection required by the present invention.

Claims

1. A pulmonary artery floating catheter based on FBG sensing technology, characterized in that: The invention comprises a balloon (1), a catheter body (2), a transfer port (3) and a transfer tube (4); the catheter body (2) is a hollow structure and one end of the catheter body is provided with an inflation hole (14); the balloon (1) is bonded to one end of the catheter body (2) and wraps around the inflation hole (14); the transfer port (3) is connected to the other end of the catheter body (2); the transfer port (3) is connected to the transfer tube (4); the transfer tube (4) is connected to an FBG connector, a temperature sensor connector (7), a proximal hole connector (8), and a distal hole connector (9); The invention relates to a catheter body (2) and a catheter head (9) and an inflation syringe (10), wherein at least one FBG connector is provided and located at different positions, and cavities are sequentially provided in the catheter body (2) along the axial direction thereof, wherein the cavities include a first cavity (21), a second cavity (22), a third cavity (23), a fourth cavity (24) and an FBG cavity, wherein one end of the first cavity (21) is a proximal hole (11), and the other end is connected to the proximal hole connector (8) through a transfer tube (4), and the second cavity (22) is connected to the inflation hole (14) and the inflation syringe (1 0), one end of the third cavity (23) is a distal hole (12), and the other end is connected to the distal hole connector (9) through a transfer tube (4), a temperature sensor (31) is bonded in the fourth cavity (24), a sensing head of the temperature sensor (31) is located at the front end opening of the fourth cavity (24), a connecting line of the temperature sensor (31) is connected to the temperature sensor connector (7), an FBG optical fiber (32) is bonded in the FBG cavity, a hole is opened at the front end of the FBG cavity, and at least one grid area on the FBG optical fiber (32) is exposed The tail end of the FBG cavity is connected to the FBG connector. When the pulmonary artery floating catheter is delivered to the measuring point, the temperature sensor (31) at the front end of the catheter body (2) can detect the blood temperature at the measuring point. At least one FBG optical fiber (32) located at a different position at the front end of the catheter body (2) can detect the coupling value of the temperature and pressure at the measuring point and deliver it to the device through the FBG connector. After the measured value is obtained, the HHO-KELM model in the device is used for decoupling, so that the real-time pressure value at the measuring point can be obtained.

2. The pulmonary artery floating catheter based on FBG sensing technology according to claim 1, characterized in that: The FBG cavities are provided with two, namely a fifth cavity (25) and a sixth cavity (26); the fifth cavity (25) and the sixth cavity (26) are arranged in a staggered manner; an FBG optical fiber (32) is bonded into each of the fifth cavity (25) and the sixth cavity (26); holes are respectively opened at the front ends of the fifth cavity (25) and the sixth cavity (26) to expose at least one grid area on the FBG optical fiber (32); and the tail ends of the fifth cavity (25) and the sixth cavity (26) are respectively connected to FBG connectors.

3. The pulmonary artery floating catheter based on FBG sensing technology according to claim 2, characterized in that: The FBG connectors are provided with two, namely the FBG1 connector (5) and the FBG2 connector (6), and the tail ends of the fifth cavity (25) and the sixth cavity (26) are connected to the FBG1 connector (5) and the FBG2 connector (6) respectively.

4. The pulmonary artery floating catheter based on FBG sensing technology according to claim 1, characterized in that: It also comprises a hollow tube, one end of which is respectively connected to the transfer tube (4), and the FBG connector, the temperature sensor connector (7), the proximal hole connector (8), the distal hole connector (9) and the inflation syringe (10) are respectively connected to the other end of the hollow tube.

5. The pulmonary artery floating catheter based on FBG sensing technology according to claim 1, characterized in that: The catheter body (2) is provided with an optical fiber glue injection hole (13) for installing an FBG optical fiber (32), an air filling hole (14), and a temperature sensor glue injection hole (15) for installing a temperature sensor (31); the optical fiber glue injection hole (13) is connected to the FBG cavity, the air filling hole (14) is connected to the second cavity (22), and the temperature sensor glue injection hole (15) is connected to the fourth cavity (24); after the FBG optical fiber (32) and the temperature sensor (31) are installed through the optical fiber glue injection hole (13) and the temperature sensor glue injection hole (15), they are bonded with biocompatible glue and the gap is filled.

6. The pulmonary artery floating catheter based on FBG sensing technology according to claim 1, characterized in that: A hydrophilic coating is provided on the outer wall of the catheter body (2), and a scale is provided every 10 cm on the hydrophilic coating.

7. The pulmonary artery floating catheter based on FBG sensing technology according to claim 1, characterized in that: The proximal hole connector (8) is connected to a syringe for infusing a specific part with fluid or ice water to measure cardiac output using a thermodilution method.

8. The pulmonary artery floating catheter based on FBG sensing technology according to claim 1, characterized in that: The distal hole connector (9) is connected to a syringe for infusing fluid into the distal end.

9. The pulmonary artery floating catheter based on FBG sensing technology according to claim 1, characterized in that: The specific method of using the adaptive closed-loop HHO-KELM model to decouple the FBG fiber data and the temperature sensor data to obtain accurate pressure values ​​is as follows: Step 1: Data acquisition and preprocessing: Use FBG fiber optic sensor to collect signal data containing temperature and pressure information, temperature sensor to collect temperature signal, and perform low-pass filtering on the collected data; Step 2: Initialize the kernel function and initial parameters to build the KELM model; use the preprocessed FBG fiber sensor data as input, temperature and pressure as output, and use the temperature parameter output by the temperature sensor to close the loop to correct the pressure output of the model, eliminating the error caused by the model in the signal detection process; Step 2.

1. Kernel function selection and parameter initialization The radial basis function is used as the kernel function of KELM, and its mathematical expression is: K(x i ,x j )=exp(-γ||x i -x j || 2 ) Among them, K(x i ,x j ) is the radial basis kernel function, ||·|| is the Euclidean distance, x i is the i-th sample, x j is the jth sample, γ is the kernel parameter, which controls the width of the kernel function. The relationship between the kernel parameter γ and the bandwidth parameter σ can be expressed as: Initialize kernel function parameters and bandwidth parameters γ0=0.5, σ0=1.0, and the initial value of regularization coefficient C is C0=100; Step 2.

2. Define input and output data structures The KELM model input data matrix is ​​the preprocessed FBG sensor signal data that constitutes the input matrix X∈R N×D , where N is the number of samples and D is the number of sensor channels; the KELM model output data matrix is ​​the target output, which is the temperature and pressure values, forming the matrix Y∈R N×2 , the first column is the temperature value, and the second column is the pressure value; Step 2.

3. Kernel matrix calculation and model construction Based on the training data X and the initial parameter γ0, calculate the kernel matrix Ω∈R N×N , the kernel matrix elements are: Ω ij =K(x i ,x j )=exp( - γ0||x i - x j || 2 ) Among them, Ω ij is the kernel matrix element calculated for individuals i and j, and then according to the KELM theory, the output weight matrix β∈R is calculated N×2 : Where I is the identity matrix; Step 2.

4. Model output The output function of KELM is defined as: in is the output of KELM, i.e. the predicted pressure and temperature The pressure output of the closed-loop correction model for the temperature parameter output by the temperature sensor is: Among them, P is the final output pressure of the model, T measure Measure the temperature for the temperature sensor; Step 3: Use the HHO algorithm to optimize the KELM model parameters. Use the HHO algorithm to optimize the kernel function parameters and regularization coefficients of the KELM model to obtain the optimal KELM model parameters. Step 3.

1. HHO algorithm parameter setting Set the number of Harris Hawk individuals M = 50 and define the maximum number of iterations T max =100, set the escape energy threshold E0∈[0,1]; the kernel parameter search range γ∈[10 -3 ,10 3 ], the regularization coefficient search range C∈[10 -3 ,10 3 ] For each Harris Hawk individual i, i = 1, 2, ..., M, a combination of kernel function parameters and regularization coefficient parameters (γ i ,C i ): c i =c min +(c max -c min )·rand(0,1) C i =C min +(C max -C min )·rand(0,1) Among them, γ min and γ max is the search lower and upper bounds of the kernel parameter γ, C min and C max are the search lower and upper limits of the regularization coefficient C, and rand(0,1) is a uniformly distributed random number; Step 3.

2. Fitness function design The mean square error of the KELM model on the training set samples is used as the fitness value to minimize the prediction error: Among them, Fitness(γ,C) is the fitness function, which is used to evaluate the quality of the parameter combination (γ,C), y k is the real temperature and pressure value, is the model prediction value, k is the sample index, and N is the number of samples; for each Harris hawk individual (γ i ,C i ), recalculate the kernel matrix Ω according to the formula in step 2 i and the weight matrix β i ; Use the training data itself as input to calculate the predicted value Calculate the fitness value of the individual i ; Step 3.

3. Harris Hawk hunting behavior simulation Step 3.3.1 Escape Energy Update In each iteration t, the escape energy E is dynamically updated, and the control algorithm shifts from global exploration to local development: Among them, T max is the maximum number of iterations. When |E|≥1, global exploration is performed and the prey is not discovered; when |E|<1, local development is performed and the prey is surrounded; Step 3.3.2 Global Exploration Phase If |E|≥1, the Harris Hawk randomly searches for the prey location, and the position update formula is expressed as: Among them, X(t+1) is the parameter position of Harris Hawk at the t+1th iteration, X(t) is the parameter position of Harris Hawk at the tth iteration, representing the parameter combination (γ, C), X rand (t) is the parameter position of the random individual in the current population at the tth iteration, X best (t) is the position of the current optimal individual at the tth iteration, X mean (t) is the average position of the population at the tth iteration, r1, r2, r3, r4 are random numbers in [0,1], q is the random probability value, L, U are the lower and upper limits of the parameter search; Step 3.3.3 Local development phase If |E|<1, according to the prey escape energy E and the random number r, the range of random number r is 0~1, select the following strategy: set soft encirclement, r≥0.5 and |E|≥0.5: X(t+1)=X best (t)-X(t)-E|JX best (t)-X(t)| Among them, J = 2(1-r5) simulates the random jumping intensity of prey, r5∈[0,1]; Set hard bracketing, r ≥ 0.5 and |E| < 0.5: X(t+1)=X best (t)-E|X best (t)-X(t)| Set a progressive fast dive, r<0.5 and |E|≥0.5, generate a random vector S∈R 2 , calculate the dive position: X temp =X best (t)-E|JX best (t)-X(t)| Among them, X temp is a temporary variable, Levy() is the random step length of Levy flight; Set up a fast dive attack, r < 0.5 and |E| < 0.5: X(t+1)=X best (t)-E|X best (t)-X mean (t)| Step 3.

4. Parameter optimization and model update When reaching T max Or stop when the fitness value converges; and record the global optimal individual X best =(γ opt ,C opt ); Step 4: Model training: Use the optimized KELM model to train the training data to ensure that the model can accurately extract temperature and pressure information; Step 4.1 Input data division: divide the preprocessed data in step 1 into training set D in a ratio of 7:3 train and validation set D val , and the output matrix Y of the training set and the validation set train and Y val One-to-one correspondence with input data; Step 4.2 Model parameter loading, obtain the kernel parameter γ optimized by the HHO algorithm from step 3 opt and the regularization coefficient C opt , based on the training set data D train and γ opt , recalculate the kernel matrix Ω train : Oh train =exp(-γ opt ||x i -x j || 2 ) Using the optimized C opt Solving for the weight matrix β opt : Cholesky decomposition is used to ensure the numerical stability of matrix inversion; the output trained function is obtained: Step 5: Use the trained adaptive HHO-KELM model to predict the measured data and obtain the decoupled values ​​of temperature and pressure.

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