Thrombectomy catheter with flow monitoring

Abstract

The present invention provides a thrombus aspiration catheter with flow monitoring. It includes: 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 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; the processing unit is electrically connected to the ultrasonic flow sensing assembly and is used to process the blood flow signal and calculate the aspiration indication information; the display module is connected to the processing unit and is used to display the aspiration indication information; the aspiration indication information includes blood flow information. Therefore, the blood flow near the suction port of the aspiration catheter can be monitored and obtained by the ultrasonic flowmeter, which helps to judge whether the suction port is aligned with the thrombus and whether the thrombus has been aspirated into the catheter, is conducive to more accurately aspirating the thrombus without unnecessarily aspirating blood, while reducing the blood loss of the patient, and is also conducive to improving the aspiration efficiency and the treatment effect.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly 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 epidemiological studies mostly regard VTE as a whole to study risk factors, natural course, etc. Its annual incidence is 100 - 200 per 100,000 people. 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 China, the incidence of PE has increased from 3.9 per 100,000 in 2001 to 11.7 per 100,000 in 2011. Clinically, relevant solutions are urgently needed.

[0004] Interventional treatment methods include transcatheter thrombus fragmentation and aspiration, or local low - dose thrombolysis at the same time. Different from traditional pulmonary artery dissection treatment, interventional treatment can reduce the damage to the patient's body caused by open surgery, effectively remove thrombus, and is a good treatment method for patients with ineffective drug treatment and thoracotomy contraindications. Interventional treatment has the characteristics of high safety and good short - term efficacy. However, compared with other treatment methods, pulmonary embolism interventional treatment 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 ability of doctors. Existing aspiration catheters are difficult to assist doctors in accurately judging whether the thrombus has been aspirated into the catheter, etc., and it is easy to cause excessive blood loss in patients.

[0005] It should be noted that the information disclosed in the above background art 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 the embodiments of the present invention is to provide a thrombus aspiration catheter with flow monitoring. By monitoring the blood flow near the aspiration port of the aspiration catheter through an ultrasonic flowmeter, it is assisted to judge whether the aspiration port is aligned with the thrombus and whether the thrombus has been aspirated into the catheter, which is beneficial to more accurately aspirate the thrombus without unnecessarily aspirating blood. While reducing the blood loss of patients, it is also beneficial to improve the aspiration efficiency and the treatment effect.

[0007] To solve the above technical problems, an embodiment of the present invention provides a thrombus aspiration catheter with flow monitoring, including:

[0008] An aspiration tube body and an aspiration handle, the proximal end of the aspiration tube body is connected to the distal end of the aspiration handle;

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

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

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

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

[0013] As an embodiment, the inner wall surface of the aspiration tube body forms a microwave pattern structure for reducing the adhesion force to thrombus.

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

[0015] One end of the aspiration handle is connected to the liquid storage tank, and the other end of the liquid storage tank is connected to an aspiration joint;

[0016] A rectifying grille with a grid-shaped cross-section is arranged in the liquid storage tank;

[0017] A negative pressure gauge for detecting the pressure in the liquid storage tank is further arranged on the liquid storage tank.

[0018] As an embodiment, the aspiration catheter further includes a liner core that can penetrate from the proximal end of the aspiration handle into the aspiration tube body and is used to assist the advancement of the aspiration catheter in the blood vessel.

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

[0020] As an embodiment, the processing unit is configured to obtain corresponding blood flow information according to the blood flow signals provided by each pair of ultrasonic flow probes, obtain the blood flow information of the suction port according to the weighted average value of the blood flow information corresponding to the two pairs of ultrasonic flow probes, and identify the thrombus aspiration state according to the blood flow information of the suction port.

[0021] As an embodiment, the aspiration catheter further includes a pressure sensing assembly disposed at the suction port for monitoring the pressure signal at the suction port; the processing unit is electrically connected to the pressure sensing assembly;

[0022] The processing unit is further configured 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 rules for identifying the thrombus aspiration state according to the blood flow information and the pressure information include:

[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 the state of aspirating thrombus;

[0025] When the thrombus aspiration state is monitored, and when 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 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 sensing assembly includes two pressure sensing probes, and four probe mounting cavities penetrating the proximal end and the distal end of the aspiration tube body are provided in the tube wall of the aspiration tube body, and the ultrasonic flow probes and the pressure sensing probes are respectively disposed in the probe mounting 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 catheter body is monitored by an ultrasonic flow sensing component provided at the distal end of the suction catheter body. The processing unit processes the blood flow signal and calculates the suction indication information, and the display module displays the suction indication information. The suction indication information may include blood flow information. During the thrombus aspiration process, after the aspiration catheter is aligned with the thrombus, the blood flow at the suction port is usually small. However, when the thrombus is aspirated into the aspiration catheter, the blood flow at the suction port instantaneously increases. Therefore, the real-time value of the blood flow can assist the operator in accurately judging whether the aspiration catheter is in the state of aspirating the thrombus and whether the thrombus has been aspirated into the catheter during aspiration. Thus, the operator can increase the aspiration negative pressure when the thrombus is located at the suction port and rapidly reduce the aspiration pressure when the thrombus has been aspirated into the catheter, reducing unnecessary blood loss of the patient, and at the same time, it is also beneficial to improve the aspiration efficiency and treatment effect, having good clinical application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. It can be understood that the following drawings are only the embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained according to the provided drawings without creative efforts.

[0030] Figure 1 The overall structural schematic diagram of the thrombus aspiration catheter with flow monitoring provided by the embodiment of the present invention;

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

[0032] Figure 3 The schematic diagram of the connection structure of the ultrasonic flow sensing component of the thrombus aspiration catheter with flow monitoring provided by the embodiment of the present invention;

[0033] Figure 4 The structural schematic diagram of the braided structure of the thrombus aspiration catheter body with flow monitoring provided by the embodiment of the present invention;

[0034] Figure 5 The structural schematic diagram of the rectifying grid of the thrombus aspiration catheter body with flow monitoring provided by the embodiment of the present invention;

[0035] Figure 6 The structural schematic diagram of the liner core of the thrombus aspiration catheter body with flow monitoring provided by the embodiment of the present invention;

[0036] Figure 7 The structural schematic diagram of the distal end of the thrombus aspiration catheter body with flow monitoring provided by the embodiment of the present invention;

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

[0038] Figure 9 Schematic diagram of the installation position of the ultrasonic flow probe of the thrombus aspiration catheter with flow monitoring provided by an embodiment of the present invention;

[0039] Figure 10 Schematic diagram of the aspiration state of the thrombus aspiration tube body with flow monitoring provided by Embodiment 1 of the present invention.

[0040] In the figure: 1. Aspiration tube body; 11. Probe installation cavity; 12. Microwave pattern; 13. Flaring port; 14. Tapered port; 15. Braided layer; 16. Aspiration cavity; 2. Aspiration handle; 3. Display module; 4. Seal; 5. Liquid storage tank; 51. Rectifying grid; 52. Negative pressure gauge; 6. Aspiration joint; 7. Liner core; 8. Ultrasonic flow probe; 81. Connector; 9. Thrombus mass. Detailed implementation manners

[0041] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the following will elaborate on each implementation manner of the present invention with reference to the accompanying drawings. However, those of ordinary skill in the art can understand that in each implementation manner of the present invention, many technical details are provided for the readers to better understand the present invention. However, even without these technical details and various changes and modifications based on the following implementation manners, the technical solutions claimed by the present invention can still be achieved.

[0042] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by terms such as "upper", "lower", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is 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 thus cannot be construed as a limitation to the present invention. In addition, terms such as "first", "second", etc. are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0043] It should be noted that unless otherwise clearly specified, terms such as "connected" and "coupled" 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 directly connected, or indirectly connected through an intermediate medium, and can be the internal communication 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, and the distal end refers to the end farther from the operator. The above definitions are only for the convenience of expression and cannot be construed as a limitation to the present invention.

[0045] Please refer to Figures 1 to 7 As shown, Embodiment 1 of the present invention provides a thrombus aspiration catheter with flow monitoring, which can be used for percutaneous thrombectomy in pulmonary embolism. The thrombus aspiration catheter with flow monitoring according to the embodiment of the present invention includes: a suction tube body 1, a suction handle 2, a processing unit (not shown in the figure), a display module 3, a liquid storage tank 5, and a suction connector 6. The proximal end of the suction tube body 1 is connected to the distal end of the suction handle 2, 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 connector 6. A negative pressure suction channel is formed by connecting the suction connector 6, the liquid storage tank, the suction handle 2, and the suction tube body 1 in communication. The ultrasonic flow sensing assembly is disposed at the distal end of the suction tube body 1 and is used to monitor the blood flow signal at the suction port of the suction tube body 1. The processing unit is electrically connected to the ultrasonic flow sensing assembly and is used to process the blood flow signal and calculate the suction indication information. The display module 3 is connected to the processing unit and is used to display the suction indication information. The suction indication information includes blood flow information.

[0046] The ultrasonic flow sensing assembly can send the real-time monitored blood flow signal at the suction port to the processing unit. After processing the blood flow signal, the processing unit can obtain the blood flow information at the suction port. The blood flow information can include the blood flow rate and / or blood velocity 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 rate at the suction port in real time during the operation. When aspirating thrombus, an aspiration catheter suitable for the thrombus volume is selected before the operation. The diameter of the aspiration catheter is usually smaller than the thrombus size, so that when the aspiration catheter is aligned with the thrombus for aspiration, the suction force can act better on the thrombus and blood loss can be reduced. However, the size specifications of the aspiration catheter are limited. In some cases, there is a certain gap between the suction port and the thrombus when aspirating the thrombus. When the operator aligns the suction port with the thrombus for aspiration under ultrasonic guidance, due to the blocking effect of the thrombus, the blood flow rate in the suction port is very small. When the thrombus has been aspirated into the aspiration catheter, the blood quickly fills the suction port, and at this time, the blood flow rate at the suction port increases rapidly. Therefore, by monitoring and displaying the blood flow information at the suction port, the operator can be effectively assisted in judging the thrombus aspiration situation, so as to accurately control the suction pressure and avoid mis-aspiration of blood.

[0047] Please refer to Figure 2, the ultrasonic flow sensing assembly includes two pairs of ultrasonic flow probes 8. Inside the tube wall of the suction tube body 1, there are four probe mounting cavities 11 that penetrate through the proximal and distal ends of the suction tube body 1, and the two pairs of ultrasonic flow probes 8 are respectively arranged inside the probe mounting cavities 11. The ultrasonic flow probes 8 are fixedly arranged inside the probe mounting cavities 11 in a sealed manner to ensure that there will be no displacement during use. The four ultrasonic flow probes 8 can be evenly distributed along the circumferential direction. Each pair of ultrasonic flow probes 8 can 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 the ultrasonic waves reflected from the fluid. The processing unit is used to obtain the corresponding blood flow information based on the blood flow signals (i.e., the reflected ultrasonic signals) provided by each pair of ultrasonic flow probes. Among them, techniques known to those skilled in the art can be used to preprocess the blood flow signals, such as amplification, filtering, and analog-to-digital conversion, etc., which will not be elaborated here. The processing unit can calculate the blood flow velocity according to the time difference method, and then calculate the blood flow based on the size of the suction tube body, so as to obtain the 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 at the same time can also identify the failed ultrasonic flow probes. The redundant design of the two pairs of ultrasonic flow probes enables there to be available ultrasonic flow probes when a certain pair of ultrasonic flow probes fails. After the processing unit determines that both pairs of ultrasonic flow probes are working properly, it can obtain the blood flow information of the suction port according to the weighted average value of the blood flow information corresponding to the two pairs of ultrasonic flow probes. The weights can be set according to the difference in the blood flow velocities monitored by the two pairs of ultrasonic flow probes, and no specific limitation is made here as long as the blood flow can be monitored more accurately. When accurate blood flow information is obtained through the ultrasonic flow sensing assembly, the doctor can judge the thrombus position according to the blood flow size and its change during the suction operation, and accurately adjust the suction negative pressure. For example, when the suction port of the suction tube body 1 is aligned with the thrombus for suction and the thrombus has not 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 initially judged that the suction port has changed from blocked to unblocked, that is, the thrombus has been sucked into the tube body. It can be understood that there is no excessive limitation on the number of ultrasonic flow probes in this embodiment, as long as the required accuracy of blood flow information 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 fluctuates to a certain extent, and there is no need to frequently update the blood flow information when the blood flow fluctuates very little. It can be understood that the processing unit can also generate a line chart of blood flow changes, etc., so that the doctor can visually observe the blood flow fluctuation situation.

[0049] As an alternative to the aforementioned intuitive display of blood flow data, the processing unit can also identify the thrombus aspiration status based on the blood flow information at the aspiration port. Specifically, the processing unit can monitor the sudden increase in blood flow event according to the blood flow information. The sudden increase in blood flow event refers to the instantaneous increase in blood flow being greater than the set threshold. When a sudden increase in blood flow event occurs, the processing unit can generate corresponding aspiration indication information, such as controlling the display module to display the 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 integrally arranged. The display module 3 and the ultrasonic flow probe 8 can be connected through a connecting member 81. The connecting member 81 can be arranged on the aspiration handle 2. The wires of the ultrasonic flow probe 8 converge on the aspiration handle and then are connected to the connecting member 81, and the connecting member 81 is connected to the display module 3. It can be understood that the display module 3 and the connecting member can adopt a detachable connection method, and different aspiration 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 pipe section of the aspiration tube body 1 is corrugated. After the thrombus enters the aspiration cavity 16 of the delivery pipe section, it is supported by the convex parts of the corrugated surface. The thrombus adheres to the wall with a very small area, which can prevent sticky objects such as thrombus from adhering to the wall and being unable to be aspirated.

[0052] Please refer to Figure Figure 1 and Figure 5 , the aspiration handle 2 is connected to one end of the liquid storage tank 5, the other end of the liquid storage tank 5 is connected to the aspiration joint 6, and the aspiration joint 6 can be connected to a negative pressure source or a syringe for aspiration. The liquid storage tank 5 can collect aspirated foreign objects and stabilize the aspiration negative pressure. A rectifying grid 51 with a grid-shaped cross-section is provided in the liquid storage tank 5, and the rectifying grid 51 can make the fluid pressure and flow rate more uniform and stable, and reduce noise at the same time. A negative pressure gauge 52 for detecting the pressure in the liquid storage tank 5 is also provided on the liquid storage tank 5. The negative pressure gauge 52 can be used to monitor the aspiration negative pressure value and can judge whether the liquid storage tank 5 is airtight.

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

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

[0055] Please refer to Figure 7 and Figure 9 , the distal inner cavity of the aspiration tube body 1 can be in the shape of a gradually expanding opening from far to near, which can play a role in expanding pressure, enhancing and stabilizing the thrombus aspiration pressure, and improving the aspiration efficiency. Please refer to Figure 8 , the proximal inner cavity of the aspiration tube body 1 can be in the shape of a gradually shrinking opening from far to near, which can play a role in accelerating speed, pumping out the thrombus faster, and at the same time, the reduced caliber can prevent the thrombus from flowing back due to misoperation.

[0056] In some examples, the aspiration catheter may further include a pressure sensing assembly disposed at the aspiration port, which is used to monitor the pressure signal at the aspiration 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 identify the thrombus aspiration 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, the pressure sensing assembly may include two pressure sensing probes, and four probe mounting cavities penetrating through the proximal and distal ends of the aspiration tube body are provided in the tube wall of the aspiration tube body. The ultrasonic flow probes and the pressure sensing probes are respectively disposed in the probe mounting cavities. The pressure sensing probes can adopt microelectromechanical pressure sensors such as piezoresistive and capacitive types. It should be noted that the pressure sensing assembly can also be a pressure sensing layer disposed on the inner cavity surface of the aspiration port of the aspiration tube body, and the pressure sensing layer can be made of biocompatible materials including but not limited to hydrogels and conductive polymers.

[0057] The judgment rules for identifying the thrombus aspiration state based on blood flow information and 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 aspiration port and is in the state of aspirating thrombus. After the state of aspirating thrombus is monitored, and when it is monitored that 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 aspiration stops, it is determined that the thrombus has been aspirated into the aspiration catheter body. Among them, the pressure threshold can be set according to the negative pressure value during negative pressure aspiration, and the average aspiration negative pressure during the aspiration 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 aspiration has been started. The first flow threshold can be set according to the empirical value of the blood flow size during negative pressure aspiration. When the size of the aspiration catheter matches the size of the thrombus, the gap between the thrombus and the aspiration catheter is small, so the flow rate is very small. The first flow threshold can be set to the flow rate value when there is a small gap between the thrombus and the aspiration port or several times of this flow rate value, and no specific limitation is made here. The reference value of the second flow threshold is obtained according to the size of the aspiration catheter and the blood flow velocity during aspiration. The second flow threshold can be set to one time or 80% of this reference value, as long as it can accurately reflect the flow rate when there is no blockage at the aspiration catheter port. The preset pressure value range refers to the pressure range of the aspiration port caused by the heart pumping function. For example, when the thrombus is aspirated into the aspiration catheter body, when there is no negative pressure aspiration acting on the aspiration port, the pressure will change with the heart beat.

[0058] The processing unit can analyze and identify the state during thrombus aspiration based on the pressure information and blood flow information, and can control the display module 3 to display the state during aspiration. When the processing unit identifies that the thrombus has been aspirated into the aspiration catheter and the aspiration port has returned to the normal state, it can control the display module 3 to display a prompt to adjust the aspiration pressure.

[0059] Combined Figure 10 As shown, the usage method of the thrombus aspiration catheter with flow monitoring according to the embodiment of the present invention is as follows:

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

[0061] Compared with the prior art, in the embodiment of the present invention, the blood flow signal at the suction port of the suction catheter body is monitored by the ultrasonic flow sensing component disposed at the distal end of the suction catheter body, the blood flow signal is processed by the processing unit and the suction indication information is calculated, and the suction indication information is displayed by the display module. The suction indication information may include blood flow information. During the thrombus aspiration process, after the aspiration catheter is aligned with the thrombus, the blood flow at the suction port is usually small, and when the thrombus is aspirated into the aspiration catheter, the blood flow at the suction port instantaneously increases. Therefore, the real-time value of the blood flow can assist the operator to accurately judge whether the aspiration catheter is in the state of aspirating the thrombus and whether the thrombus has been aspirated into the catheter during aspiration. Thus, the operator can increase the suction negative pressure when the thrombus is at the suction port and rapidly reduce the suction pressure when the thrombus has been aspirated into the catheter, reducing unnecessary blood loss of the patient, and at the same time facilitating the improvement of the aspiration efficiency and the treatment effect, having good clinical application value. At the same time, the present invention can also comprehensively analyze and identify the thrombus aspiration state according to the blood flow and pressure information at the suction port.

[0062] Those of ordinary skill in the art can understand that the above-described embodiments are specific embodiments for implementing the present invention, and in actual applications, various changes can be made in form and details 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 connected to the processing unit and used to display the suction indication information; the suction indication information includes blood flow information; The inner cavity at the distal end of the suction tube body is in a gradually expanding shape from far to near, and the inner cavity at the proximal end of the suction tube body is in a gradually shrinking shape from far to near; The inner wall surface of the suction tube body forms a micro-corrugated structure for reducing adhesion force to thrombus.

2. 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.

3. 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.

4. 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.

5. The thrombus aspiration catheter with flow monitoring according to claim 4, 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.

6. 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.

7. The thrombus aspiration catheter with flow monitoring according to claim 6, 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.

8. The thrombus aspiration catheter with flow monitoring according to claim 6, 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.

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