Thrombus removal system and method of use

Abstract

The present application relates to the field of medical device technology, and more specifically, to a thrombus removal system and a method of use. The thrombus removal system provided by the present invention includes a separately arranged balloon catheter and a stent catheter, the distal end of the balloon catheter is provided with a blocking balloon, the proximal side of the blocking balloon is provided with a thrombus-breaking stent, the thrombus-breaking stent is connected to the distal end of the stent catheter, the balloon catheter can be movably connected to the stent catheter, the stent catheter is provided with a suction lumen for removing the broken thrombus, and the suction lumen is communicated with a Luer connector provided at the proximal end of the stent catheter. The thrombus removal system of the present invention can block thrombi and prevent thrombi from escaping through the combined use of a blocking balloon and a thrombus-breaking stent, and can also play the role of removing and breaking thrombi.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and more specifically, to a thrombus removal system and a method of use. Background Art

[0002] Thromboembolic diseases are increasingly becoming a major global health problem. Studies have shown that one-quarter of hospitalization deaths worldwide are related to thrombosis, and the top three causes of cardiovascular disease deaths are all related to thrombosis, making it the number one cause of death among the global population.

[0003] Pulmonary embolism (PE) is one of the three most common fatal cardiovascular diseases. It is characterized by high incidence, high disability rate and high mortality rate. It is a serious and emergency disease of the respiratory system. More than 200,000 people die from PE-related diseases in the United States each year, and 544,000 people die from related diseases in Europe each year. This means that about one person dies from PE every 6 minutes in the United States, and one person dies from PE every 15 seconds around the world.

[0004] PE is the third leading cause of cardiovascular death after coronary heart disease and stroke. If left 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.

[0005] PE treatment is an emerging field of endovascular interventional therapy, and people are actively exploring the ideal treatment method to deal with this life-threatening disease. The ideal PE treatment device should have the following characteristics: it can be used by a single operator; it has minimal bleeding and perioperative risks; it effectively resolves clots; and it has minimal blood loss.

[0006] Interventional treatment of acute pulmonary embolism mainly includes catheter thrombolysis and catheter-based thrombectomy / resection. For thrombi in the arterial system, such as clots in cerebral blood vessels, over the past 20 years, treatment options have gradually evolved from drug thrombolysis to the current mechanical thrombectomy. Now, clinically, interventional thrombectomy with cerebrovascular stents has become a guideline-recommended nursing method, and it is expected that mechanical thrombectomy can be performed directly, breaking the tradition of "thrombolysis first and then thrombectomy". Summary of the invention

[0007] The purpose of the present application is to provide a thrombus removal system and a method of use, which has a simple structure, is easy to operate, is easy to remove and break up thrombi, prevents thrombi from escaping, and can achieve a good thrombus removal effect.

[0008] In order to achieve the above-mentioned objectives, in a first aspect, the present invention provides a thrombus removal system, comprising a separately arranged balloon catheter and a stent catheter, wherein a blocking balloon is arranged at the distal end of the balloon catheter, a thrombus-breaking stent is arranged at the proximal side of the blocking balloon, the thrombus-breaking stent is connected to the distal end of the stent catheter, the balloon catheter can be movably inserted into the stent catheter, a suction lumen for removing broken thrombi is arranged in the stent catheter, and the suction lumen is communicated with a Luer connector arranged at the proximal end of the stent catheter.

[0009] In an optional embodiment, the embolism stent comprises an elastically deformable mesh stent, a release outer tube for expanding or contracting the embolism stent is movably sleeved on the outer side of the stent catheter, and a push-pull head is connected to the proximal end of the release outer tube.

[0010] In an optional embodiment, a fixed short tube is connected to the thrombus-breaking stent, the proximal end of the fixed short tube is fixedly connected to the stent catheter, and the distal end of the fixed short tube is an open structure with a gap between it and the balloon catheter.

[0011] In an optional embodiment, a balloon branch for inserting the balloon catheter is provided on the Luer connector, and a balloon cavity is provided in the stent catheter, and the balloon cavity is communicated with the balloon branch.

[0012] In an optional embodiment, the proximal end of the balloon catheter is connected to a balloon connector, which is exposed from the balloon branch and includes a guide wire port and a pressure inflation and relief port.

[0013] In an optional embodiment, the balloon catheter includes a double-lumen tube, in which a pressure inflation and pressure relief lumen and a guidewire lumen are respectively provided, the guidewire lumen is connected to the guidewire tube passing through the blocking balloon, and the pressure inflation and pressure relief lumen is sealably connected to the proximal end of the blocking balloon.

[0014] In an optional embodiment, a developing ring is installed on the guide wire tube, and the developing ring is arranged inside the blocking balloon;

[0015] The distal ends of the fixed short tube and the releasing outer tube respectively include developing tubes.

[0016] In an optional embodiment, the Luer connector includes a suction tube port, the suction cavity is connected to the suction tube port, and the suction tube port is connected to an aspirator for aspirating the broken thrombus.

[0017] In an optional embodiment, a spare lumen is further provided in the stent catheter, a spare branch is provided on the Luer connector, and the spare lumen is communicated with the spare branch.

[0018] In a second aspect, the present invention provides a method for using the thrombus removal system according to any one of the aforementioned embodiments, comprising the following steps:

[0019] Under the guidance of the guidewire, the thrombus-breaking stent in a compressed state is placed at the distal end of the thrombus through the stent catheter;

[0020] The thrombus-breaking stent is released, and the blocking balloon is delivered to the distal end of the thrombus-breaking stent along the suction channel of the stent catheter;

[0021] Inflate the balloon catheter with pressure to make the occlusion balloon occlude the distal end of the blood vessel;

[0022] Connect the aspirator to the Luer connector, open the aspirator while pulling the thrombus-breaking stent backward, and remove the thrombus in the blood vessel cavity after being broken by the thrombus-breaking stent by suction;

[0023] With the aspirator turned on, the thrombus-breaking stent and the stent catheter are withdrawn from the human body, and then the thrombus-breaking stent and the stent catheter are inserted into the blood vessel again;

[0024] After the above operation is repeated 2-3 times, the pressure of the occluding balloon is released, and the occluding balloon, thrombus-breaking stent and guide wire are withdrawn from the human body.

[0025] By movably inserting the balloon catheter into the stent catheter and combining the separate arrangement of the balloon catheter and the stent catheter, the thrombus-breaking stent and the blocking balloon can be independently placed in the blood vessel cavity.

[0026] The balloon catheter can be movably connected to the stent catheter. After the thrombus-breaking stent enters the blood vessel cavity and is expanded and positioned, the balloon catheter can be extended into the distal end of the thrombus-breaking stent through the stent catheter, so that the inflated blocking balloon can block the distal end of the blood vessel to prevent the escape of the thrombus in the blood vessel cavity, making the thrombus on the proximal side of the blocking balloon clear more completely and fully.

[0027] After the thrombus-breaking stent breaks up the thrombus in the blood vessel, the broken thrombus is sucked out of the body through the suction cavity in the stent catheter. The suction cavity is connected to the Luer connector outside the body, and negative pressure can be drawn into the blood vessel cavity by connecting the aspirator to the Luer connector to ensure that the thrombus is completely removed.

[0028] The thrombus removal system in the present invention can block the thrombus and prevent the escape of the thrombus through the combined use of the blocking balloon and the thrombus-breaking stent, and can also play the role of removing and breaking the thrombus. The proximal Luer connector is used in conjunction with the stent catheter, and the three devices of the thrombus-breaking stent, the blocking balloon, and the guide wire can be used independently. The suction cavity is connected to the Luer connector, and the thrombus after the thrombus is broken in the blood vessel can be more efficiently, quickly, and conveniently aspirated. The suction effect is cleaner and more thorough, thereby effectively treating pulmonary embolism.

[0029] Other features and advantages of the present application will be described in detail in the subsequent detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0031] Figure 1 It is a schematic diagram of the overall structure of the thrombus removal system in this application;

[0032] Figure 2 This is a schematic diagram of the structure of the embolus-breaking stent, stent catheter and Luer connector in this application;

[0033] Figure 3 This is a schematic diagram of the structure of the embolism-breaking stent in the present application in a compressed state, a release catheter, and the embolism-breaking stent;

[0034] Figure 4 This is a schematic diagram of the structure of the occluding balloon, balloon catheter and balloon connector in this application;

[0035] Figure 5 It is a schematic diagram of the internal structure of the balloon catheter in this application;

[0036] Figure 6 Schematic diagram of the internal structure of the stent catheter in this application.

[0037] icon:

[0038] 1-balloon catheter; 11-balloon connector; 12-guidewire port; 13-pressure charging and pressure relief port; 14-pressure charging and pressure relief cavity; 15-guidewire cavity; 16-guidewire tube; 17-developing ring;

[0039] 2-Stent catheter; 21-Suction cavity; 22-Fixed short tube; 23-Balloon cavity; 24-Backup cavity;

[0040] 3-occluding balloon;

[0041] 4-Broken bolt support;

[0042] 5- Luer connector; 51- Balloon branch; 52- Suction tube port; 53- Spare branch;

[0043] 6-release outer tube; 61-push-pull head;

[0044] 7-developing tube;

[0045] 8- Aspirator. DETAILED DESCRIPTION

[0046] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations.

[0047] In the description of this application, it should be noted that the terms "inside", "outside", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the application is usually placed when in use, which is only for the convenience of describing this application and simplifying the description, and does not indicate or imply 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 a limitation on this application. In addition, the terms "first", "second", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0048] In the description of this application, it should also be noted that, unless otherwise clearly specified and limited, the terms "disposed" and "connected" 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 communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0049] The thrombus removal system in the present application mainly removes thrombi in blood vessels by combining stent thrombus fragmentation and suction removal, which is different from the existing stent thrombus removal process.

[0050] In the existing technology, stent thrombectomy is one of the effective means to treat vascular embolism. Stent thrombectomy uses a minimally invasive interventional treatment method to place a thrombectomy stent at the site of the thrombus through a catheter. After a few minutes, the stent combines with the thrombus and directly grasps the thrombus blocking the blood vessel, pulling the thrombus out of the blood vessel to reopen the blocked blood vessel. Compared with other treatment methods, stent thrombectomy has the advantages of less trauma, faster results and thorough efficacy.

[0051] The common treatments for pulmonary embolism are catheter thrombolysis and catheter embolectomy. These two treatments have significant effects on new thrombi, but the disadvantage is that it is difficult to completely remove old large thrombi. However, pulmonary embolism is mostly subacute thrombi or old thrombi. Stent thrombectomy can effectively remove old thrombi, and has the advantages of high efficiency, short operation time, low risk of distal embolism, and few complications.

[0052] The thrombus removal system in the present invention is an improvement based on the stent thrombectomy. Specifically, the thrombus in the blood vessel is first broken up by the stent, and then the broken thrombus is sucked out of the body through the catheter by negative pressure suction. Compared with the stent thrombectomy, the thrombus attached to the stent can be prevented from falling back into the blood vessel during the process of being pulled out of the blood vessel. The thrombus in the blood vessel can be removed more thoroughly by suction. At the same time as the suction, the blood vessel is further blocked by a balloon arranged at the distal end of the thrombus. While ensuring the suction force to enhance the suction removal effect, the thrombus is prevented from escaping from the distal end of the blood vessel.

[0053] See also Figure 1 The main structure of the thrombus removal system of the present invention includes a balloon catheter 1 and a stent catheter 2 which are separately arranged. The balloon and the stent can be placed separately and independently in the blood vessel. In specific operation, the stent can be placed at the distal end of the thrombus in the blood vessel through the stent catheter 2, and then the balloon catheter 1 is passed through the stent, and the balloon is extended to the distal end of the blood vessel, so that the distal end of the blood vessel can be blocked by the inflated balloon.

[0054] Specifically, a blocking balloon 3 is provided at the distal end of the balloon catheter 1, and a thrombus-breaking stent 4 is provided on the proximal side of the blocking balloon 3. The thrombus-breaking stent 4 is provided at the distal end of the stent catheter 2. The thrombus-breaking stent 4 can be placed at the distal end of the thrombus through the stent catheter 2. Combined with the form in which the balloon catheter 1 can be movably connected to the stent catheter 2, the blocking balloon 3 before inflation can be extended from the distal end of the stent catheter 2.

[0055] There is no connection between the balloon catheter 1 and the stent catheter 2 in the present invention. After the thrombus-breaking stent 4 is inserted and positioned, the balloon catheter 1 can pass through the stent catheter 2 and drive the pre-inflated blocking balloon 3 to the distal end of the thrombus-breaking stent 4.

[0056] In the specific use process, the thrombus-breaking stent 4 is first delivered to the distal end of the thrombus site through the stent catheter 2, and then the thrombus-breaking stent 4 is expanded at the distal end of the thrombus. Then the pre-pressurized blocking balloon 3 is delivered to the distal end of the thrombus-breaking stent 4 through the balloon catheter 1, and specifically the balloon catheter 1 drives the pre-pressurized blocking balloon 3 to extend from the opening at the distal end of the stent catheter 2 and further extend forward to the distal end of the thrombus-breaking stent 4 for a distance, and the blocking balloon 3 is pressurized, so that the expanded blocking balloon 3 blocks the distal end of the blood vessel to prevent the thrombus from escaping from the distal end of the blood vessel.

[0057] In the present invention, the intravascular thrombus is broken specifically by moving the thrombus-breaking stent 4 in the blood vessel, and further, the thrombus-breaking stent 4 is moved backward along the blood vessel cavity to scrape and break the thrombus in the blood vessel. A suction cavity 21 for removing the broken thrombus is provided in the stent catheter 2, and a Luer connector 5 is connected to the proximal end of the stent catheter 2, and a suction tube port 52 is provided on the Luer connector 5. The suction cavity 21 is specifically connected to the suction tube port 52. During the suction process, the suction tube port 52 is connected to the aspirator 8, and the broken thrombus is sucked out of the body through the suction cavity 21 under the suction negative pressure provided by the aspirator 8.

[0058] Combination Figure 2-Figure 3 Based on the above-mentioned expansion of the thrombus-breaking stent 4 at the distal end of the thrombus, in one specific embodiment, the thrombus-breaking stent 4 includes a compressed state and an expanded state. The thrombus-breaking stent 4 is delivered to the distal end of the thrombus in the blood vessel in the compressed state, and is expanded by being released after reaching the set position.

[0059] Specifically, the thrombus-breaking stent 4 includes an elastically deformable mesh stent, and the elastically deformable mesh stent can retract along the same expansion deformation path. A release outer tube 6 for expanding or contracting the thrombus-breaking stent 4 is movably sleeved on the outside of the stent catheter 2. During the transportation process, the thrombus-breaking stent 4 in a compressed state is contracted and accommodated in the release outer tube 6. When the thrombus-breaking stent 4 needs to be expanded and extended, the release outer tube 6 is withdrawn to free it from the restraint on the thrombus-breaking stent 4. At the same time, when the thrombus-breaking stent 4 needs to be compressed again, the release outer tube 6 can be pushed forward again to make the thrombus-breaking stent 4 return to the compressed state along the same deformation trajectory.

[0060] In order to conveniently control the state change of the thrombus-breaking stent 4, a push-pull head 61 is connected to the proximal end of the release outer tube 6. The push-pull head 61 is arranged outside the body and can be conveniently pushed and pulled to change the state of the thrombus-breaking stent 4. At the same time, by reciprocating the push-pull head 61 on the release outer tube 6, the thrombus adsorbed on the mesh stent can be effectively broken in the compression and expansion transition, reducing the generation of large-sized thrombi and preventing large-sized thrombi from blocking the mesh stent and the suction channel.

[0061] The mesh support structure of the thrombus-breaking support 4 in this embodiment can allow the broken thrombus to pass through and enter the suction cavity 21 in the support catheter 2. At the same time, based on the movable connection of the balloon catheter 1 in the support catheter 2, the thrombus can also enter the suction cavity 21 through the annular gap between the distal end of the support catheter 2 and the balloon catheter 1, ensuring that the broken thrombus can be fully removed through the suction cavity 21.

[0062] At the same time, in order to enable the thrombus-breaking stent 4 to reliably follow the stent catheter 2 to be transported into the blood vessel, the thrombus-breaking stent 4 is fixed to the end of the stent catheter 2, and a fixed short tube 22 is connected to the thrombus-breaking stent 4. The proximal end of the fixed short tube 22 is welded and fixed to the stent catheter 2, which is used to fix the thrombus-breaking stent 4 on the stent catheter 2. The distal end of the fixed short tube 22 is an open structure, and a gap is left between the balloon catheter 1 to form an annular gap between the distal end of the stent catheter 2 and the balloon catheter 1. This setting ensures the connection reliability of the stent catheter 2 during transportation and deformation, and at the same time expands the three-dimensional space for the thrombus to enter the suction cavity 21 on the stent catheter 2.

[0063] See also Figure 4 In another specific embodiment, the Luer connector 5 is provided with a balloon branch 51 for the balloon catheter 1 to extend therein, and the stent catheter 2 is provided with a balloon cavity 23 for the balloon catheter 1 to penetrate therein, and the balloon cavity 23 is communicated with the balloon branch 51. During the insertion of the balloon catheter 1, the distal end of the balloon catheter 1 enters from the balloon branch 51 on the Luer connector 5 and extends into the balloon cavity 23 in the stent catheter 2.

[0064] Furthermore, a balloon connector 11 is connected to the proximal end of the balloon catheter 1. During use, the balloon connector 11 is exposed to the balloon branch 51 and includes a guide wire port 12 and a pressure-charging and pressure-releasing port 13. Specifically, the balloon connector 11 is disposed outside the body, and the guide wire port 12 and the pressure-charging and pressure-releasing port 13 facilitate the insertion of the guide wire and the pressure-charging and pressure-releasing operations on the occluding balloon 3.

[0065] Combination Figure 5-Figure 6 The balloon catheter 1 in this embodiment includes a double-lumen tube, and a pressure-charging and pressure-relieving lumen 14 and a guidewire lumen 15 are respectively arranged inside the double-lumen tube. The guidewire lumen 15 is sealedly connected to a guidewire tube 16 passing through the blocking balloon 3, and the pressure-charging and pressure-relieving lumen 14 is sealedly connected to the proximal end of the blocking balloon 3, which can ensure that the balloon catheter 1 reaches the lesion site under the guidance of the guidewire, and at the same time ensure the normal inflation and pressure relief of the blocking balloon 3.

[0066] It should be pointed out that in the present invention, during the process of extending the stent catheter 2 into the blood vessel, the tail end of the guidewire can be extended into the balloon cavity 23 in the stent catheter 2 and pass through the balloon branch 51 from the tail end of the guidewire. After the stent catheter 2 enters the blood vessel cavity under the guidance of the guidewire, the guidewire can also be reliably guided during the subsequent extension of the balloon catheter 1, thereby ensuring that the stent catheter 2 and the balloon catheter 1 reliably enter the blood vessel cavity under the action of the same guidewire.

[0067] A developing ring 17 is installed on the guide wire tube 16, and the developing ring 17 is arranged inside the blocking balloon 3. At the same time, the distal ends of the fixed short tube 22 and the release outer tube 6 respectively include developing tubes 7. Through the above-mentioned setting method, the balloon catheter 1, the stent catheter 2 and the release outer tube 6 can be accurately and reliably positioned, and while satisfying the normal input of each tube into the blood vessel cavity, the relative position relationship of the blocking balloon 3, the thrombus-breaking stent 4 and the release outer tube 6 can be effectively determined, thereby facilitating the distal blood vessel blocking operation and the deformation of the thrombus-breaking stent 4 between compression and expansion.

[0068] In one preferred embodiment, the Luer connector 5 includes a suction nozzle 52, the suction cavity 21 is sealed and connected to the suction nozzle 52, and an aspirator 8 for aspirating the broken thrombus is connected to the suction nozzle 52. The aspirator 8 in this embodiment can be locked to the suction nozzle 52. When the suction operation is required, the aspirator 8 is locked with the suction nozzle 52, and the aspirator 8 is turned on, combined with the blocking balloon 3 at the distal end of the blood vessel, to ensure that the applied suction negative pressure fully and reliably acts on the blood vessel cavity.

[0069] The stent catheter 2 is also provided with a spare lumen 24, and the Luer connector 5 is provided with a spare branch 53, and the spare lumen 24 is sealed and communicated with the spare branch 53. By providing the spare lumen 24, the function in the suction operation can be expanded to meet the actual requirements of specific thrombus suction.

[0070] When the suction device 8 of the present invention is in operation, it is necessary to block the balloon branch 51 and the backup branch 53 on the Luer connector 5 to prevent air leakage in the balloon branch 51 and the backup branch 53, so as to enhance the effect of the suction force generated by the suction device 8.

[0071] In addition to the above-mentioned thrombus removal system, the present invention also provides a method for using the above-mentioned thrombus removal system to remove thrombus in the blood vessel cavity. Specifically, the method comprises the following steps:

[0072] Under the guidance of the guide wire, the stent catheter 2 is inserted into the blood vessel, and the thrombus-breaking stent 4 in a compressed state is passed through the thrombus site through the stent catheter 2 and placed at the distal end of the thrombus;

[0073] When the thrombus-breaking stent 4 reaches the predetermined position, the release outer tube 6 is withdrawn to release the restraint of the thrombus-breaking stent 4, thereby releasing the thrombus-breaking stent 4, and the blocking balloon 3 is transported along the suction cavity 21 of the stent catheter 2 to the distal end of the thrombus-breaking stent 4;

[0074] After the balloon catheter 1 reaches the predetermined position, the pressure-charging and pressure-releasing cavity 14 in the balloon catheter 1 is pressurized so that the blocking balloon 3 blocks the distal end of the blood vessel to prevent the thrombus from escaping from the distal end of the blood vessel;

[0075] After the above operation is completed, the suction device 8 is locked and connected to the suction pipe opening 52 of the Luer connector 5, so that the suction device 8 is tightly connected to the suction pipe opening 52 to ensure reliable sealing of the connection part;

[0076] The thrombus-breaking stent 4 is withdrawn along the blood vessel cavity to break up the thrombus and scrape the thrombus. While the thrombus-breaking stent 4 is pulled back, the aspirator 8 is opened to remove the thrombus in the blood vessel cavity after being broken up by the thrombus-breaking stent 4 by suction.

[0077] The thrombus-breaking stent 4 and the stent catheter 2 are withdrawn from the human body, and the aspirator 8 is turned on at the same time to break and aspirate the thrombus in the blood vessel through which the thrombus is withdrawn, and then the thrombus-breaking stent 4 and the stent catheter 2 are inserted into the blood vessel cavity again to block the proximal end of the balloon 3;

[0078] Repeat the above suction operation 2-3 times to completely remove the thrombus in the blood vessel;

[0079] After the suction is completed, the blocking balloon 3 is depressurized, and the blocking balloon 3, the thrombus-breaking stent 4 and the guide wire are withdrawn from the human body along the blood vessel cavity.

[0080] The thrombus removal system and method of use of the present invention can effectively and thoroughly remove thrombi in the pulmonary artery, ensuring that pulmonary embolism is treated promptly, effectively and reliably.

[0081] It should be noted that, in the absence of conflict, the features in the embodiments of this application may be combined with each other.

[0082] The above description is only the preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A thrombus removal system, characterized in that: It includes a balloon catheter and a stent catheter which are separately arranged, and the balloon catheter and the stent catheter can be placed independently in the blood vessel; The distal end of the balloon catheter is provided with a blocking balloon, the proximal side of the blocking balloon is provided with a thrombus-breaking stent, the thrombus-breaking stent is connected to the distal end of the stent catheter, the balloon catheter can be movably connected in the stent catheter, a suction cavity for removing the broken thrombus is provided in the stent catheter, and the suction cavity is communicated with a Luer connector provided at the proximal end of the stent catheter; The thrombus-breaking stent comprises an elastically deformable mesh stent, an outer release tube for expanding or contracting the thrombus-breaking stent is movably sleeved on the outer side of the stent catheter, a push-pull head is connected to the proximal end of the release tube, and the push-pull head is arranged outside the body; The thrombus-breaking stent is connected with a fixed short tube, the proximal end of the fixed short tube is fixedly connected to the stent catheter, and the distal end of the fixed short tube is an open structure with a gap between the fixed short tube and the balloon catheter; The gap includes an annular gap provided between the distal end of the stent catheter and the balloon catheter, and the annular gap is communicated with the suction cavity; There is no connection between the balloon catheter and the stent catheter. After the thrombus-breaking stent is inserted and positioned, the balloon catheter can pass through the stent catheter and drive the pre-pressurized blocking balloon to the distal end of the thrombus-breaking stent. The thrombus-breaking stent includes a compressed state and an expanded state. The thrombus-breaking stent is delivered to the distal end of the thrombus in the blood vessel in the compressed state, and is expanded and inflated by being released after reaching the set position. The thrombus in the blood vessel is scraped and broken by moving the broken stent backward along the blood vessel lumen; When the thrombus removal system is used, the following steps are included: Under the guidance of the guidewire, the thrombus-breaking stent in a compressed state is placed at the distal end of the thrombus through the stent catheter; The thrombus-breaking stent is released, and the blocking balloon is delivered to the distal end of the thrombus-breaking stent along the suction channel of the stent catheter; Inflate the balloon catheter with pressure to make the occlusion balloon occlude the distal end of the blood vessel; Connect the aspirator to the Luer connector, open the aspirator while pulling the thrombus-breaking stent backward, and remove the thrombus in the blood vessel cavity after being broken by the thrombus-breaking stent by suction; With the aspirator turned on, the thrombus-breaking stent and the stent catheter are withdrawn from the human body, and then the thrombus-breaking stent and the stent catheter are inserted into the blood vessel again; After the above operation is repeated 2-3 times, the pressure of the occluding balloon is released, and the occluding balloon, thrombus-breaking stent and guide wire are withdrawn from the human body.

2. The thrombus removal system according to claim 1, characterized in that: The Luer connector is provided with a balloon branch for the balloon catheter to extend into, and the stent catheter is provided with a balloon cavity, which is communicated with the balloon branch.

3. The thrombus removal system according to claim 2, characterized in that: The proximal end of the balloon catheter is connected with a balloon connector, which is exposed outside the balloon branch and includes a guide wire port and a pressure-charging and pressure-relieving port.

4. The thrombus removal system according to claim 1, characterized in that: The balloon catheter comprises a double-lumen tube, wherein a pressure-inflating and pressure-releasing lumen and a guidewire lumen are respectively arranged inside the double-lumen tube, wherein the guidewire lumen is connected to the guidewire tube passing through the blocking balloon, and the pressure-inflating and pressure-releasing lumen is sealedly connected to the proximal end of the blocking balloon.

5. The thrombus removal system according to claim 4, characterized in that: A developing ring is installed on the guide wire tube, and the developing ring is arranged inside the blocking balloon; The distal ends of the fixed short tube and the releasing outer tube respectively include developing tubes.

6. The thrombus removal system according to claim 2, characterized in that: The Luer connector comprises a suction tube opening, the suction cavity is connected to the suction tube opening, and the suction tube opening is connected to an aspirator for aspirating the broken thrombus.

7. The thrombus removal system according to claim 2, characterized in that: A spare cavity is also provided in the stent catheter, a spare branch is provided on the Luer connector, and the spare cavity is communicated with the spare branch.

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