Thrombus aspiration catheter with flow monitoring function

Abstract

The invention provides a thrombus aspiration catheter with a flow monitoring function. The device comprises a suction tube body, a suction handle, an ultrasonic flow sensing assembly, a processing unit and a display module, the ultrasonic flow sensing assembly is arranged at the far end of the suction pipe body and used for monitoring a blood flow signal at a suction opening of the suction pipe body. The processing unit is electrically connected with the ultrasonic flow sensing assembly and is used for processing the blood flow signal and calculating to obtain suction indication information; the display module is connected with the processing unit and is used for displaying the suction indication information; the suction indication information comprises blood flow information. Therefore, the blood flow near the suction port of the suction catheter can be obtained through monitoring of the ultrasonic flowmeter, whether the suction port is aligned with the thrombus or not and whether the thrombus is sucked into the catheter or not can be judged in an auxiliary mode, the thrombus can be sucked more accurately without unnecessarily drawing out blood, blood loss of a patient is reduced, meanwhile, the suction efficiency is improved, and the blood taking time is shortened. The treatment effect is improved.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a thrombus aspiration catheter with flow monitoring. Background Art

[0002] Pulmonary embolism (PE) is a general term for a group of diseases or clinical syndromes caused by various emboli blocking the pulmonary artery or its branches, including pulmonary thromboembolism (PTE), fat embolism syndrome, amniotic fluid embolism, air embolism, tumor embolism, etc., among which PTE is the most common type of pulmonary embolism.

[0003] Acute pulmonary embolism is the most serious clinical manifestation of VTE. In most cases, acute pulmonary embolism is secondary to DVT. Existing epidemiology mostly studies VTE as a whole to study risk factors, natural course, etc. Its annual incidence is 100-200 / 100,000. PE is the third leading cause of cardiovascular death after coronary heart disease and stroke. If untreated, its 30-day mortality rate is 30%, and 11% of patients die within the first hour after admission. In my country, the incidence of PE has increased from 3.9 / 100,000 in 2001 to 11.7 / 100,000 in 2011, and clinical solutions are urgently needed.

[0004] Interventional treatment methods include catheter-based thrombus fragmentation and aspiration, or local low-dose thrombolysis at the same time. Interventional treatment is different from traditional pulmonary artery open surgery. Interventional treatment can reduce the damage of open surgery to the patient's body and effectively remove thrombi. It is a good treatment method for patients who have no obvious effect on drug treatment and have contraindications to open-chest surgery. Interventional treatment has the characteristics of high safety and good short-term efficacy. However, compared with other treatment methods, interventional treatment of pulmonary embolism is still in the development stage. There is a lack of interventional devices developed for the treatment of pulmonary embolism in clinical practice. Operations such as aspiration catheters require high professional knowledge, practical work experience and surgical capabilities of doctors. Existing aspiration catheters are difficult to assist doctors in making accurate judgments on whether the thrombus has been drawn into the catheter and other aspiration conditions, which can easily cause excessive blood loss in patients.

[0005] It should be noted that the information disclosed in the above background technology section is only used to enhance the understanding of the background of the present disclosure, and therefore may include information that does not constitute the prior art known to those skilled in the art. Summary of the invention

[0006] The purpose of an embodiment of the present invention is to provide a thrombus aspiration catheter with flow monitoring, which monitors the blood flow near the suction port of the aspiration catheter through an ultrasonic flowmeter, and assists in judging whether the suction port is aligned with the thrombus and whether the thrombus has been drawn into the catheter. This is conducive to more accurate aspiration of the thrombus without unnecessary blood extraction, and while reducing the patient's blood loss, it is also conducive to improving the aspiration efficiency and improving the treatment effect.

[0007] In order to solve the above technical problems, an embodiment of the present invention provides a thrombus aspiration catheter with flow monitoring, comprising:

[0008] A suction tube body and a suction handle, wherein the proximal end of the suction tube body is connected to the distal end of the suction handle;

[0009] An ultrasonic flow sensor assembly, which is disposed at the distal end of the suction tube body and is used to monitor the blood flow signal at the suction port of the suction tube body;

[0010] a processing unit, which is electrically connected to the ultrasonic flow sensor assembly and is used to process the blood flow signal and calculate the suction indication information;

[0011] A display module is connected to the processing unit and is used to display the suction indication information; the suction indication information includes blood flow information.

[0012] As an embodiment, the inner cavity at the distal end of the suction tube body is in a gradually expanding shape from far to near, and / or the inner cavity at the proximal end of the suction tube body is in a gradually contracting shape from far to near.

[0013] As an embodiment, the inner wall surface of the suction tube body forms a micro-corrugated structure for reducing adhesion to thrombus.

[0014] As an embodiment, the suction catheter further includes a liquid storage tank;

[0015] The suction handle is connected to one end of the liquid storage tank, and the other end of the liquid storage tank is connected to the suction joint;

[0016] The liquid storage tank is provided with a rectifying grid having a grid-shaped cross section;

[0017] The liquid storage tank is also provided with a negative pressure gauge for detecting the pressure in the liquid storage tank.

[0018] As an embodiment, the suction catheter further includes a liner core which can be inserted into the suction tube body from the proximal end of the suction handle and is used to assist in advancing the suction catheter within the blood vessel.

[0019] As an embodiment, the ultrasonic flow sensor assembly includes two pairs of ultrasonic flow probes; four probe installation cavities penetrating the proximal and distal ends of the suction tube body are provided in the tube wall of the suction tube body, and the two pairs of ultrasonic flow probes are respectively arranged in the probe installation cavities.

[0020] As an embodiment, the processing unit is used to obtain corresponding blood flow information based on the blood flow signals provided by each pair of ultrasonic flow probes, and obtain the blood flow information of the suction port based on the weighted average of the blood flow information corresponding to the two pairs of ultrasonic flow probes, and identify the thrombus suction status based on the blood flow information of the suction port.

[0021] As an embodiment, the suction catheter further comprises a pressure sensing component disposed at the suction port, which is used to monitor the pressure signal at the suction port; the processing unit is electrically connected to the pressure sensing component;

[0022] The processing unit is further used to obtain blood flow information according to the blood flow signal, obtain pressure information according to the pressure signal, and identify the thrombus aspiration state according to the blood flow information and the pressure information.

[0023] As an embodiment, the judgment rule for identifying the thrombus aspiration state according to the blood flow information and the pressure information includes:

[0024] When the real-time pressure value is greater than the pressure threshold and the real-time blood flow is less than the first flow threshold, it is determined that the thrombus is located at the suction port and is in a thrombus suction state;

[0025] When the thrombus aspiration state is monitored, and when the real-time blood flow value is monitored to be greater than the second flow threshold and the real-time pressure value is within the preset pressure value range when the aspiration is stopped, it is determined that the thrombus has been aspirated into the aspiration tube body.

[0026] As an embodiment, the ultrasonic flow sensor assembly includes two ultrasonic flow probes, the pressure sensor assembly includes two pressure sensor probes, and the tube wall of the suction tube body is provided with four probe installation cavities that penetrate the proximal and distal ends of the suction tube body, and the ultrasonic flow probe and the pressure sensor probe are respectively arranged in the probe installation cavities.

[0027] It can be seen from the above technical solutions that the embodiments of the present invention have at least the following advantages and positive effects:

[0028] The blood flow signal at the suction port of the suction tube body is monitored by an ultrasonic flow sensor component arranged at the distal end of the suction tube body, the blood flow signal is processed by a processing unit and suction indication information is calculated, and the suction indication information is displayed by a display module. The suction indication information may include blood flow information. During the thrombus suction process, after the suction catheter is aligned with the thrombus, the blood flow at the suction port is usually small, and when the thrombus is sucked into the suction catheter, the blood flow at the suction port increases instantly. Therefore, the real-time value of the blood flow can assist the operator to accurately judge whether the suction catheter is in a state of suction aimed at the thrombus during suction and whether the thrombus has been sucked into the catheter, so that the operator can increase the suction negative pressure when the thrombus is located at the suction port, and quickly reduce the suction pressure when the thrombus has been sucked into the catheter, thereby reducing unnecessary blood loss in patients. At the same time, it is also beneficial to improve the suction efficiency and improve the treatment effect, and has good clinical application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. It can be understood that the drawings in the following description are only embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying creative work.

[0030] Figure 1 A schematic diagram of the overall structure of a thrombus aspiration catheter with flow monitoring provided by an embodiment of the present invention;

[0031] Figure 2 A schematic diagram of the installation structure of an ultrasonic flow probe of a thrombus aspiration catheter with flow monitoring provided by an embodiment of the present invention;

[0032] Figure 3 A schematic diagram of the connection structure of an ultrasonic flow sensor assembly of a thrombus aspiration catheter with flow monitoring provided by an embodiment of the present invention;

[0033] Figure 4 A schematic structural diagram of a braided structure of a thrombus aspiration tube body with flow monitoring provided in an embodiment of the present invention;

[0034] Figure 5 A schematic diagram of the structure of a rectifying grid of a thrombus aspiration tube body with flow monitoring provided by an embodiment of the present invention;

[0035] Figure 6 A schematic structural diagram of a lining core of a thrombus aspiration tube body with flow monitoring provided by an embodiment of the present invention;

[0036] Figure 7 A schematic diagram of the structure of the distal end of a thrombus aspiration tube body with flow monitoring provided by an embodiment of the present invention;

[0037] Figure 8 A schematic diagram of the structure of the distal end of a thrombus aspiration tube body with flow monitoring provided by an embodiment of the present invention;

[0038] Fig. 9 A schematic diagram of the installation position of an ultrasonic flow probe of a thrombus aspiration catheter with flow monitoring provided by an embodiment of the present invention;

[0039] Fig.10 This is a schematic diagram of the suction state of the thrombus aspiration tube body with flow monitoring provided in the first embodiment of the present invention.

[0040] In the figure: 1. Suction tube body; 11. Probe installation cavity; 12. Micro-corrugation; 13. Gradual expansion; 14. Gradual contraction; 15. Braided layer; 16. Suction cavity; 2. Suction handle; 3. Display module; 4. Seal; 5. Liquid storage tank; 51. Rectifier grid; 52. Negative pressure gauge; 6. Suction connector; 7. Lining core; 8. Ultrasonic flow probe; 81. Connector; 9. Thrombus block. DETAILED DESCRIPTION

[0041] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, it can be understood by those skilled in the art that in the embodiments of the present invention, many technical details are provided to enable readers to better understand the present invention. However, even without these technical details and various changes and modifications based on the following embodiments, the technical scheme claimed in the present invention can be implemented.

[0042] In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", etc., are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0043] It should be noted that, unless otherwise expressly specified, the terms "connected", "connected", etc. should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal connection of two elements.

[0044] In the description of the present invention, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator. The above definition is only for the convenience of expression and cannot be understood as a limitation of the present invention.

[0045] See also Figure 1 to Figure 7 As shown, the first embodiment of the present invention provides a thrombus aspiration catheter with flow monitoring, which can be used for interventional aspiration and thrombus aspiration of pulmonary embolism. The thrombus aspiration catheter with flow monitoring of the embodiment of the present invention includes: an aspiration tube body 1, an aspiration handle 2, a processing unit (not shown), a display module 3, a liquid storage tank 5 and a suction joint 6. The proximal end of the aspiration tube body 1 is connected to the distal end of the aspiration handle 2, the aspiration handle 2 is connected to one end of the liquid storage tank 5, and the other end of the liquid storage tank 5 is connected to the aspiration joint 6. The suction joint 6, the liquid storage tank, the aspiration handle 2 and the aspiration tube body 1 are connected to form a negative pressure aspiration channel. The ultrasonic flow sensor component is arranged at the distal end of the aspiration tube body 1 and is used to monitor the blood flow signal at the aspiration port of the aspiration tube body 1. The processing unit is electrically connected to the ultrasonic flow sensor component for processing the blood flow signal and calculating the aspiration indication information. The display module 3 is connected to the processing unit and is used to display the aspiration indication information. The aspiration indication information includes blood flow information.

[0046] The ultrasonic flow sensor assembly can send the blood flow signal at the suction port monitored in real time to the processing unit. The processing unit can obtain the blood flow information at the suction port after processing the blood flow signal. The blood flow information may include the blood flow rate and / or blood flow rate at the suction port. The display module can display the blood flow information at the suction port in real time, so that the operator can observe the blood flow at the suction port in real time during the operation. When aspirating a thrombus, a suction catheter that matches the volume of the thrombus will be selected before the operation. The diameter of the suction catheter is usually smaller than the size of the thrombus, so that when the suction catheter is aimed at the thrombus for aspiration, the suction force acts better on the thrombus and reduces blood loss. However, the size specifications of the suction catheter are limited. In some cases, when aspirating a thrombus, there is a certain gap between the suction port and the thrombus. When the operator aims the suction port at the thrombus for aspiration under ultrasound guidance, due to the blocking effect of the thrombus, the blood flow in the suction port is very small. When the thrombus has been sucked into the suction catheter, blood is quickly poured into the suction port, and the blood flow at the suction port increases rapidly. Therefore, by monitoring and displaying the blood flow information at the suction port, the operator can effectively assist in judging the thrombus suction situation, thereby accurately controlling the suction pressure and avoiding accidental suction of blood.

[0047] Please refer to Figure 2The ultrasonic flow sensor assembly includes two pairs of ultrasonic flow probes 8. Four probe installation cavities 11 are provided in the wall of the suction tube body 1, which penetrate the proximal end and the distal end of the suction tube body 1, and the two pairs of ultrasonic flow probes 8 are respectively arranged in the probe installation cavities 11. The ultrasonic flow probe 8 is fixedly arranged in the probe installation cavity 11 in a sealed manner to ensure that no displacement occurs during use. The four ultrasonic flow probes 8 can be evenly distributed along the circumference. Each pair of ultrasonic flow probes 8 may include: an ultrasonic transmitter and an ultrasonic receiver, the ultrasonic transmitter is used to generate ultrasonic waves, and the ultrasonic receiver is used to receive ultrasonic waves reflected from the fluid. The processing unit is used to obtain corresponding blood flow information according to the blood flow signal (i.e., the reflected ultrasonic signal) provided by each pair of ultrasonic flow probes. Among them, the blood flow signal can be pre-processed by using techniques known to those skilled in the art, such as amplification, filtering, and analog-to-digital conversion, which will not be repeated here. The processing unit can calculate the blood flow velocity according to the time difference method, and then calculate the blood flow according to the size of the suction tube body, thereby obtaining blood flow information.

[0048] The processing unit can first calibrate each pair of ultrasonic flow probes according to the blood flow information of the two pairs of ultrasonic flow probes, and can also identify the failed ultrasonic flow probes. The redundant design of the two pairs of ultrasonic flow probes can ensure that there are still available ultrasonic flow probes when a pair of ultrasonic flow probes fails. After the processing unit determines that the two pairs of ultrasonic flow probes are working normally, it can obtain the blood flow information of the suction port according to the weighted average of the blood flow information corresponding to the two pairs of ultrasonic flow probes. The weight can be set according to the difference in blood flow velocity monitored by the two pairs of ultrasonic flow probes, and there is no specific restriction here, as long as the blood flow rate can be monitored more accurately. When accurate blood flow information is obtained through the ultrasonic flow sensing component, the doctor can determine the location of the thrombus according to the size and change of the blood flow during the suction operation, and accurately adjust the suction negative pressure. For example, when the suction port of the suction tube body 1 is aimed at the thrombus for suction and the thrombus has not yet been sucked into the suction tube body 1, the blood flow near the suction port is very small. At the moment when the thrombus is sucked into the tube body, the blood flow at the suction port increases rapidly. Therefore, when the doctor observes that the blood flow suddenly increases to a certain value during suction, it can be preliminarily judged that the suction port has changed from being blocked to being unobstructed, that is, the thrombus has been sucked into the tube body. It can be understood that this embodiment does not impose excessive restrictions on the number of ultrasonic flow probes, and blood flow information with the required accuracy can be obtained. It should be noted that the processing unit can control the display module 3 to output updated blood flow data when the blood flow fluctuation reaches a certain level, and there is no need to frequently update the blood flow information when the blood flow fluctuation is very small. It can be understood that the processing unit can also generate a blood flow change line graph, etc., so that the doctor can intuitively observe the blood flow fluctuation.

[0049] As an alternative to the aforementioned intuitive display of blood flow data, the processing unit can also identify the thrombus aspiration state based on the blood flow information of the aspiration port. Specifically, the processing unit can monitor the blood flow surge event based on the blood flow information, and the blood flow surge event refers to the instantaneous increase in blood flow greater than the set threshold. When a blood flow surge event occurs, the processing unit can generate corresponding aspiration indication information, such as controlling the display module to display aspiration pause information.

[0050] Please refer to Figure 3 , the ultrasonic flow probe 8 is connected to the processing unit through a wire. The processing unit and the display module 3 can be integrated. The display module 3 and the ultrasonic flow probe 8 can be connected through a connector 81. The connector 81 can be set on the suction handle 2. The wires of the ultrasonic flow probe 8 are connected to the connector 81 after converging at the suction handle, and the connector 81 is connected to the display module 3. It can be understood that a detachable connection can be adopted between the display module 3 and the connector, and different suction catheters can share the processing unit and the display module 3.

[0051] Please continue to refer to Figure 2 The inner wall surface of the delivery tube section of the suction tube body 1 is corrugated. After the thrombus enters the suction cavity 16 of the delivery tube section, it is supported by the raised portion of the corrugated surface. The thrombus adheres to the wall in a very small area, which can prevent sticky objects such as thrombus from adhering to the wall and being unable to be sucked out.

[0052] Please refer to the figure Figure 1 as well as Figure 5 The suction handle 2 is connected to one end of the liquid storage tank 5, and the other end of the liquid storage tank 5 is connected to the suction joint 6. The suction joint 6 can be connected to a negative pressure source or a syringe for suction. The liquid storage tank 5 can collect suction foreign matter and stabilize the suction negative pressure. The liquid storage tank 5 is provided with a rectifying grid 51 with a grid-shaped cross-section. The rectifying grid 51 can make the fluid pressure and flow rate more uniform and stable, while reducing noise. The liquid storage tank 5 is also provided with a negative pressure gauge 52 for detecting the pressure in the liquid storage tank 5. The negative pressure gauge 52 can be used to monitor the suction negative pressure value, and it can be determined whether the liquid storage tank 5 is leaking.

[0053] Please refer to Figure 4 The structure diagram of the braided layer 15 of the suction tube body 1 is shown. The suction tube body 1 is a braided metal mesh co-extruded tube, and the braided metal wire is stainless steel wire, which can increase the rigidity of the suction catheter and facilitate the advancement of the instrument in the human body lumen.

[0054] Please refer to Figure 6The suction catheter may also include a liner core 7 that can be inserted from the proximal end of the suction handle 2 into the suction tube body 1 and is used to assist the suction catheter in advancing in the blood vessel. The liner core 7 can further increase the rigidity of the suction catheter, making it easier to advance the suction catheter in the blood vessel or lumen of the human body. A rubber plug seal is provided in the suction handle 2 to seal the guide wire and liner core that penetrate into the suction handle 2. When the liner core 7 is withdrawn, the seal 4 can be used to seal the proximal end of the suction handle 2 to form a negative pressure suction channel.

[0055] See also Figure 7 and Fig. 9 The inner cavity at the distal end of the suction tube body 1 may be gradually expanded from far to near, which can play a role in expanding pressure, enhancing and stabilizing the thrombus suction pressure, and improving the suction efficiency. Figure 8 The inner cavity at the proximal end of the suction tube body 1 may be in a gradually narrowing shape from far to near, which may increase the speed and allow the thrombus to be extracted more quickly. Meanwhile, the reduced caliber may prevent the thrombus from flowing back due to misoperation.

[0056] In some examples, the suction catheter may also include a pressure sensing assembly disposed at the suction port, which is used to monitor the pressure signal at the suction port. The processing unit is electrically connected to the pressure sensing assembly. The processing unit is also used to obtain pressure information based on the pressure signal, and to identify the thrombus suction state based on the blood flow information and pressure information provided by the ultrasonic flowmeter. Specifically, the ultrasonic flow sensor assembly may include two ultrasonic flow probes, and the pressure sensing assembly may include two pressure sensing probes. Four probe mounting cavities that pass through the proximal and distal ends of the suction tube body are provided in the tube wall of the suction tube body, and the ultrasonic flow probe and the pressure sensing probe are respectively disposed in the probe mounting cavity. The pressure sensing probe may be a micro-electromechanical pressure sensor such as a piezoresistive type or a capacitive type. It should be noted that the pressure sensing assembly may also be a pressure sensing layer disposed on the inner cavity surface of the suction port of the suction tube body, and the pressure sensing layer may be made of biocompatible materials including but not limited to hydrogels, conductive polymers, and the like.

[0057] The judgment rule for identifying the thrombus suction state according to the blood flow information and the pressure information may include: when the real-time pressure value is greater than the pressure threshold and the real-time blood flow is less than the first flow threshold, it is determined that the thrombus is located at the suction port and is in the thrombus suction state. After the thrombus suction state is monitored, and the real-time blood flow value is greater than the second flow threshold and the real-time pressure value is within the preset pressure value range when the suction is stopped, it is determined that the thrombus has been sucked into the suction tube body. Among them, the pressure threshold can be set according to the negative pressure value during negative pressure suction, and the average suction negative pressure of the suction operation is used as the pressure threshold. When the real-time pressure value is greater than the pressure threshold, it indicates that the negative pressure suction has been started. The first flow threshold can be set according to the empirical value of the blood flow size during negative pressure suction. When the size of the suction catheter matches the size of the thrombus, the gap between the thrombus and the suction tube is small, so the flow is very small. The first flow threshold can be set to the flow value when there is a small gap between the thrombus and the suction port or several times the flow value, and no specific restrictions are made here. The reference value of the second flow threshold is obtained according to the size of the suction catheter and the blood flow velocity during suction. The second flow threshold can be set to one times or 80% of the reference value, as long as it can accurately reflect the flow when the suction catheter port is not blocked. The preset pressure value range refers to the pressure range of the suction port caused by the heart's pumping function. For example, when a thrombus is sucked into the suction tube body, the pressure at the suction port will change with the heart beat when there is no suction negative pressure.

[0058] The processing unit can identify the state of thrombus aspiration based on pressure information and blood flow information analysis, and can control the display module 3 to display the aspiration state. When the processing unit identifies that the thrombus is aspirated into the aspiration catheter and the aspiration port is in a normal state, it can control the display module 3 to display a prompt for adjusting the aspiration pressure.

[0059] Combination Fig.10 As shown, the method of using the thrombus aspiration catheter with flow monitoring according to the embodiment of the present invention is as follows:

[0060] As attached Fig.10 , the suction catheter equipped with the liner core 7 is introduced into the thrombus through the guide wire, and the blood flow can be detected by the ultrasonic flow probe at the distal end of the suction catheter to assist in confirming whether the thrombus position has been reached. After reaching the target position, the liner core is withdrawn, the suction catheter connector is connected to a syringe or a negative pressure device, and negative pressure suction is started. The real-time pressure indicated by the negative pressure gauge on the liquid storage tank can be observed, and the flow change at the suction port of the suction catheter can be observed through the display module. If the flow rate increases significantly, it indicates that the thrombus has been sucked into the suction catheter. At this time, the negative pressure is reduced and suction is continued to pull the thrombus out of the body. After the thrombus suction is completed, the device is withdrawn.

[0061] Compared with the prior art, the embodiment of the present invention monitors the blood flow signal at the suction port of the suction tube body through the ultrasonic flow sensor component arranged at the distal end of the suction tube body, processes the blood flow signal through the processing unit and calculates the suction indication information, and displays the suction indication information through the display module. The suction indication information may include blood flow information. During the thrombus suction process, after the suction catheter is aligned with the thrombus, the blood flow at the suction port is usually small, and when the thrombus is sucked into the suction catheter, the blood flow at the suction port increases instantly. Therefore, the real-time value of the blood flow can assist the operator to accurately judge whether the suction catheter is in the state of aligning with the thrombus suction during suction and whether the thrombus has been sucked into the catheter, so that the operator can increase the suction negative pressure when the thrombus is located at the suction port, and quickly reduce the suction pressure when the thrombus has been sucked into the catheter, thereby reducing unnecessary blood loss of the patient, and at the same time, it is also beneficial to improve the suction efficiency and improve the treatment effect, and has good clinical application value. At the same time, the present invention can also identify the thrombus suction state according to the comprehensive analysis of the blood flow and pressure information at the suction port.

[0062] Those skilled in the art will appreciate that the above-mentioned embodiments are specific examples for implementing the present invention, and in actual applications, various changes may be made thereto in form and detail without departing from the spirit and scope of the present invention.

Claims

1. A thrombus aspiration catheter with flow monitoring, characterized in that: include: A suction tube body and a suction handle, wherein the proximal end of the suction tube body is connected to the distal end of the suction handle; An ultrasonic flow sensor assembly, which is disposed at the distal end of the suction tube body and is used to monitor the blood flow signal at the suction port of the suction tube body; a processing unit, which is electrically connected to the ultrasonic flow sensor assembly and is used to process the blood flow signal and calculate the suction indication information; A display module is connected to the processing unit and is used to display the suction indication information; the suction indication information includes blood flow information.

2. The thrombus aspiration catheter with flow monitoring according to claim 1, characterized in that: The inner cavity at the distal end of the suction tube body is in a gradually expanding shape from far to near, and / or the inner cavity at the proximal end of the suction tube body is in a gradually shrinking shape from far to near.

3. The thrombus aspiration catheter with flow monitoring according to claim 1, characterized in that: The inner wall surface of the suction tube body forms a micro-corrugated structure for reducing adhesion force to thrombus.

4. The thrombus aspiration catheter with flow monitoring according to claim 1, characterized in that: The suction catheter also includes a fluid storage tank; The suction handle is connected to one end of the liquid storage tank, and the other end of the liquid storage tank is connected to the suction joint; The liquid storage tank is provided with a rectifying grid having a grid-shaped cross section; The liquid storage tank is also provided with a negative pressure gauge for detecting the pressure in the liquid storage tank.

5. The thrombus aspiration catheter with flow monitoring according to claim 1, characterized in that: The suction catheter also includes a liner core which can be inserted into the suction tube body from the proximal end of the suction handle and is used to assist the suction catheter in advancing in the blood vessel.

6. The thrombus aspiration catheter with flow monitoring according to claim 1, characterized in that: The ultrasonic flow sensor assembly includes two pairs of ultrasonic flow probes; four probe installation cavities penetrating the proximal and distal ends of the suction tube body are arranged in the tube wall of the suction tube body, and the two pairs of ultrasonic flow probes are respectively arranged in the probe installation cavities.

7. The thrombus aspiration catheter with flow monitoring according to claim 6, characterized in that: The processing unit is used to obtain corresponding blood flow information according to the blood flow signals provided by each pair of ultrasonic flow probes, and to obtain the blood flow information of the suction port according to the weighted average of the blood flow information corresponding to the two pairs of ultrasonic flow probes, and to identify the thrombus suction state according to the blood flow information of the suction port.

8. The thrombus aspiration catheter with flow monitoring according to claim 1, characterized in that: The suction catheter further comprises a pressure sensing component disposed at the suction port, which is used to monitor the pressure signal at the suction port; the processing unit is electrically connected to the pressure sensing component; The processing unit is further used to obtain blood flow information according to the blood flow signal, obtain pressure information according to the pressure signal, and identify the thrombus aspiration state according to the blood flow information and the pressure information.

9. The thrombus aspiration catheter with flow monitoring according to claim 8, characterized in that: The judgment rules for identifying the thrombus aspiration state according to the blood flow information and pressure information include: When the real-time pressure value is greater than the pressure threshold and the real-time blood flow is less than the first flow threshold, it is determined that the thrombus is located at the suction port and is in a thrombus suction state; When the thrombus aspiration state is monitored, and when the real-time blood flow value is monitored to be greater than the second flow threshold and the real-time pressure value is within the preset pressure value range when the aspiration is stopped, it is determined that the thrombus has been aspirated into the aspiration tube body.

10. The thrombus aspiration catheter with flow monitoring according to claim 8, characterized in that: The ultrasonic flow sensor assembly includes two ultrasonic flow probes, the pressure sensor assembly includes two pressure sensor probes, and the tube wall of the suction tube body is provided with four probe installation cavities that penetrate the proximal end and the distal end of the suction tube body, and the ultrasonic flow probe and the pressure sensor probe are respectively arranged in the probe installation cavities.

Images