Thrombus removal system and thrombus removal method

Abstract

The thrombus removing system is characterized in that an inner catheter is provided with a through catheter inner cavity, an inner core tube is movably sleeved with the inner catheter, a catheter layer gap between the inner wall of the inner catheter and the outer wall of the inner core tube forms a thrombus sucking channel, the thrombus sucking channel is used for being connected with a negative pressure device, and a thrombus filtering component is provided with a thrombus filtering cavity. The plug filtering part is connected with the inner core tube and the inner catheter, the plug filtering cavity is communicated with the plug sucking channel, the plug breaking part is connected with the inner catheter and located in the plug filtering cavity of the plug filtering part, the outer sheath tube is provided with a through sheath tube inner cavity, and the outer sheath tube is movably arranged outside the inner catheter in a sleeving mode and used for collecting the plug filtering part and the plug breaking part. When the thrombus removing system is used for removing the thrombus in the target blood vessel, separation of the thrombus and the target blood vessel, smashing of the thrombus, suction of the smashed thrombus and one-time pushing of the thrombus removing system can be carried out at the same time, the purpose of removing the thrombus can be achieved, the operation difficulty of an operation is effectively simplified, and the operation time of the operation is shortened.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a thrombus removal system and a thrombus removal method. Background Art

[0002] Deep Venous Thrombosis (DVT) is caused by abnormal coagulation of blood in deep veins and is prone to occur in the lower extremities. Deep venous thrombosis easily leads to increased venous pressure, blocked blood return, and conditions such as limb swelling, pain, and dysfunction. If not effectively treated in the acute stage, it is likely to cause thrombus intensification, venous obstruction, loss of valve function, venous reflux, and venous hypertension, resulting in Post Thrombosis Syndrome (PTS), causing long-term pain, affecting the quality of life and working ability, and seriously endangering limb survival and threatening life safety. Moreover, some thrombi may also have the risk of detachment. If the detached thrombus reaches the pulmonary artery with the impact of blood flow, it will also cause Pulmonary Embolism (PE), leading to death.

[0003] Conventional treatment methods for deep venous thrombosis include catheter-directed thrombolysis (CDT) and percutaneous mechanical thrombectomy (PMT), etc. For example, a basket for capturing thrombi can be used to separate the thrombus from the venous vessel wall, and at the same time, the thrombus is collected in the basket, and then the basket is pulled back to pull the thrombus out of the body. Although the basket can remove thrombi and restore blood circulation, due to the large load of lower extremity venous thrombi, the basket often needs to enter the blood vessel multiple times for thrombus removal operations, and the basket needs to be cleaned each time after pulling out the thrombus. Not only is the operation time long and the operation cumbersome, but also the basket is in direct contact with the blood vessel, with the risk of damaging the blood vessel and venous valve. If the thrombus escapes from the basket and drifts into the pulmonary artery, there is also the risk of forming pulmonary embolism. Summary of the Invention

[0004] Based on this, it is necessary to provide a thrombus removal system and a thrombus removal method for at least one of the above-mentioned technical problems.

[0005] This application provides a thrombus removal system, and the thrombus removal system includes:

[0006] An inner core tube;

[0007] An inner catheter, the inner catheter has a through catheter lumen, the inner catheter is movably sleeved outside the inner core tube, and the tube layer gap between the inner wall of the inner catheter and the outer wall of the inner core tube forms a thrombus suction channel;

[0008] A filter plug component, which is respectively connected to the inner core tube and the inner catheter. The filter plug component has a filter plug cavity, and the filter plug cavity is communicated with the thrombus aspiration channel;

[0009] A thrombus fragmentation component, which is connected to the inner core tube or the inner catheter, and the thrombus fragmentation component is located in the filter plug cavity of the filter plug component.

[0010] In one embodiment, the thrombus removal system includes:

[0011] An outer sheath tube, which has a through sheath lumen. The outer sheath tube is movably sleeved outside the inner catheter for bundling the filter plug component and the thrombus fragmentation component; and / or,

[0012] A negative pressure device, which is communicated with the thrombus aspiration channel; and / or,

[0013] A driving device, which is used to drive the inner catheter to rotate relative to the inner core tube. The driving device includes a driving motor and a gear assembly. The gear assembly includes a driving gear and a driven gear that mesh with each other. The driving gear is connected to the output end of the driving motor, and the driven gear is fixed on the inner catheter.

[0014] In one embodiment, the distal end of the thrombus fragmentation component is movably connected to the inner core tube, and the proximal end of the thrombus fragmentation component is fixedly connected to the inner catheter; and / or,

[0015] The filter plug component is movably sleeved outside the inner core tube through the filter plug cavity. The distal end of the filter plug component is fixedly connected to the inner core tube, and the proximal end of the filter plug component is movably connected to the inner catheter. The filter plug component has a deformation function, and the axial relative movement between the inner core tube and the inner catheter is used to adjust the radial contour size of the filter plug component.

[0016] In one embodiment, a rotation assembly element is arranged at the distal end of the thrombus fragmentation component. The rotation assembly element has a through assembly hole, and the rotation assembly element is rotatably sleeved outside the inner core tube through the assembly hole; and / or,

[0017] At least one of the inner catheter and the filter plug component is provided with a rotation limiting structure. The proximal end of the filter plug component is movably connected to the inner catheter through the rotation limiting structure. The rotation limiting structure is used to limit the axial movement of the proximal end of the filter plug component relative to the inner catheter and allow the inner catheter to rotate circumferentially relative to the filter plug component; and / or,

[0018] The inner core tube has a through core tube inner cavity. A guiding component is provided at the distal end of the inner core tube. The guiding component has a through guiding channel, and the guiding channel communicates with the core tube inner cavity of the inner core tube. The distal end of the filter plug component is fixedly connected to the inner core tube through the guiding component.

[0019] In one embodiment, the rotation limiting structure includes an annular limiting groove formed on the outer wall of the inner catheter and an annular limiting portion provided at the proximal end of the filter plug component. The annular limiting portion is rotationally assembled with the annular limiting groove, such that the inner catheter can rotate circumferentially relative to the annular limiting portion, and axial movement of the annular limiting portion relative to the inner catheter is restricted.

[0020] In one embodiment, an attachment tube is provided at the distal end of the inner catheter. The attachment tube has a through attachment inner cavity. The outer wall of the proximal region of the attachment tube is fixedly connected to the inner wall of the inner catheter, such that the attachment inner cavity of the attachment tube communicates with the catheter inner cavity of the inner catheter. The proximal end of the thrombus-breaking component has a thrombus-breaking pipe orifice. The outer wall of the distal region of the attachment tube is fixedly connected to the inner wall of the thrombus-breaking pipe orifice of the thrombus-breaking component. The outer wall of the attachment tube is used to form the annular limiting groove; and / or,

[0021] The proximal end of the filter plug component has a filter plug pipe orifice, and the filter plug pipe orifice is movably sleeved outside the annular limiting groove and is used to form the annular limiting portion.

[0022] In one embodiment, the surface of the filter plug component includes a filter plug region and a hollowed-out region. The filter plug region is located in the distal direction of the hollowed-out region. Filter plug micro-holes are formed in the filter plug region, and the diameter of the filter plug micro-holes is between 10 μm and 1 mm.

[0023] In one embodiment, the filter plug component includes a deformable frame body. The interior of the deformable frame body forms the filter plug cavity. A film body provided with the filter plug micro-holes is arranged in the distal region of the deformable frame body and is used to form the filter plug region. Other regions of the deformable frame body exposed outside the film body form the hollowed-out region.

[0024] In one embodiment, a core tube connection element is provided at the proximal end of the inner core tube. The core tube connection element has a through core tube connection hole, and the core tube connection hole communicates with the core tube inner cavity; and / or,

[0025] A catheter connection element is provided at the proximal end of the inner catheter. The catheter connection element has a through catheter connection hole. The catheter connection element is sleeved outside the inner core tube through the catheter connection hole. The proximal and distal ends of the catheter connection element are sealed with the inner core tube. The catheter connection element is provided with a catheter drainage hole communicating with the catheter connection hole. The catheter drainage hole communicates with the thrombus aspiration channel through the catheter connection hole. The thrombus aspiration channel is used to be connected with a negative pressure device through the catheter drainage hole; and / or,

[0026] A sheath connection element is provided at the proximal end of the outer sheath tube. The sheath connection element has a through sheath connection hole. The sheath connection element is sleeved outside the inner catheter through the sheath connection hole. The proximal and distal ends of the sheath connection element are sealed with the inner catheter. The sheath connection element is provided with a sheath drainage hole communicating with the sheath connection hole. The sheath drainage hole communicates with the tube layer gap between the inner wall of the outer sheath tube and the outer wall of the inner catheter through the sheath connection hole.

[0027] The present application provides a thrombus removal method based on the thrombus removal system. The thrombus removal method includes the following steps:

[0028] Capturing a target object into the thrombus filtration cavity through the thrombus filtration component;

[0029] Controlling the relative rotation of the inner catheter and the inner core tube, and then driving the thrombus fragmentation component to rotate in the thrombus filtration cavity of the thrombus filtration component to crush the target object in the thrombus filtration cavity;

[0030] Aspirating the crushed target object through the thrombus aspiration channel.

[0031] In the above thrombus removal system and thrombus removal method, the thrombus removal system can be used to separate thrombus on the inner wall of a target blood vessel. And through the structural design of the thrombus removal system and cooperation with a negative pressure device, a driving device, etc., functions such as crushing thrombus, aspirating thrombus, and removing thrombus can be integrated. When using the thrombus removal system to remove thrombus in a target blood vessel, separation of the thrombus from the target blood vessel, crushing of the thrombus, and aspiration of the fragmented thrombus can be carried out simultaneously. One push of the thrombus removal system can achieve the purpose of thrombus removal, effectively simplifying the operation difficulty of the surgery and reducing the operation time of the surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 It is a schematic structural diagram of a thrombus removal system provided by an embodiment of the present application.

[0033] Figure 2 As Figure 1 shown, it is a partial enlarged structural diagram of the thrombus removal system.

[0034] Figure 3 A partial enlarged structural schematic diagram of a thrombus removal system as shown in Figure 2 Figure

[0035] Figure 4 A structural schematic diagram of a thrombus filter component provided by an embodiment of the present application.

[0036] Figure 5 A structural schematic diagram of a thrombus filter component provided by another embodiment of the present application.

[0037] Reference numerals in the drawings:

[0038] 1000, inner core tube; 2000, inner catheter; 3000, thrombus filter component; 4000, thrombus fragmentation component; 5000, outer sheath tube; 6000, negative pressure device;

[0039] 1000a, guiding component; 1000b, core tube connection element;

[0040] 2000a, catheter connection element;

[0041] 3000a, thrombus filter cavity; 3000b, thrombus filter orifice; 3000c, thrombus filter area; 3000d, hollowed-out area; 3000e, deformation frame; 3000f, film body;

[0042] 3100, rotation limiting structure; 3100a, attachment pipe; 3100a1, attachment inner cavity;

[0043] 4000a, rotation assembly element; 4000b, thrombus fragmentation orifice;

[0044] 5000a, sheath tube connection element;

[0045] 7100, drive motor; 7200, gear assembly; 7200a, driving gear; 7200b, driven gear. Detailed implementation manners

[0046] To make the above objects, features, and advantages of the present application more apparent and understandable, the following detailed description of the specific implementation manners of the present application will be made in conjunction with the accompanying drawings. Many specific details are set forth in the following description to fully understand the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present application. Therefore, the present application is not limited by the specific embodiments disclosed below.

[0047] In the description of the present application, it should be understood that if there are terms such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., the orientation or positional relationship indicated by these terms is based on the orientation or positional relationship shown in the drawings. These are only for the convenience of describing the present application 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. Therefore, it should not be construed as a limitation to the present application. Among them, the "axial", "radial", and "circumferential" in the present application can be descriptions for the thrombectomy device, and can also be descriptions for any component in the thrombectomy device such as the inner core tube, inner catheter, filter thrombus component, thrombus fragmentation component, outer sheath tube, etc.

[0048] In addition, if there are terms such as "first" and "second", these terms are only for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present application, if there is a term "plurality", the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise specifically defined.

[0049] In the present application, unless otherwise clearly specified and limited, if there are terms such as "mounted", "connected", "connected to", "fixed", etc., these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and can be the communication inside two elements or the interaction relationship between two elements, unless otherwise clearly limited. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.

[0050] In the present application, unless otherwise clearly specified and limited, if there is a description such as a first feature being "on" or "under" a second feature, the meaning can be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on" the second feature can mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature has a higher horizontal height than the second feature. The first feature being "under", "beneath" and "under" the second feature can be that the first feature is directly below or obliquely below the second feature, or simply means that the first feature has a lower horizontal height than the second feature.

[0051] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or there can also be an intermediate element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intermediate element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are only for the purpose of illustration and do not represent the only implementation.

[0052] To describe the thrombus removal system more clearly, the term "distal end" is hereby defined as the end far from the operator during the surgical operation, and the "proximal end" is defined as the end close to the operator during the surgical operation. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by those skilled in the technical field to which this application belongs. The terms used in this application in the specification are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0053] An embodiment of this application provides a thrombus removal system, which can be referred to Figure 1 . During the thrombus removal process, the thrombus removal system can integrate functions such as crushing thrombus, sucking thrombus, and removing thrombus. When using the thrombus removal system to remove thrombus in the target blood vessel, the separation of the thrombus from the target blood vessel, the crushing of the thrombus, and the aspiration of the fragmented thrombus can be carried out simultaneously. One push of the thrombus removal system can complete the purpose of thrombus removal, effectively simplifying the operation difficulty of the surgery and reducing the operation time of the surgery.

[0054] Refer to Figures 1 to 3 As shown, the thrombus removal system includes components such as an inner core tube 1000, an inner catheter 2000, an outer sheath tube 5000, a thrombus filter component 3000, and a thrombus fragmentation component 4000. The inner catheter 2000 has a through catheter lumen, and the inner catheter 2000 is movably sleeved outside the inner core tube 1000. The tube layer gap between the inner wall of the inner catheter 2000 and the outer wall of the inner core tube 1000 can form a thrombus suction channel. Therefore, the thrombus suction channel can be a channel with an annular radial cross-section. The inner catheter 2000 can be made of a polymer tube, or the inner catheter 2000 can also be made of a braided tube. The braided wires of the braided tube can be made of metal wires. When making the inner catheter 2000 with a braided tube, a relatively thin polymer outer layer can be provided on the outer wall of the braided tube.

[0055] The filter plug component 3000 has a filter plug cavity 3000a for accommodating thrombus in the target blood vessel. Through a mesh, porous or similar structure design, it allows blood to flow smoothly, but the thrombus needs to be captured within the filter plug cavity 3000a. The thrombus fragmentation component 4000 is connected to the inner catheter 2000, so the inner catheter 2000 can be used to drive the movement of the thrombus fragmentation component 4000, and the mechanical force formed by the movement of the thrombus fragmentation component 4000 is used to crush the thrombus. The thrombus fragmentation component 4000 is located in the filter plug cavity 3000a of the filter plug component 3000. Therefore, during the process of removing the thrombus, the filter plug cavity 3000a can first accommodate the thrombus, and the thrombus fragmentation component 4000 can crush the thrombus in the filter plug cavity 3000a. The thrombus fragmentation component 4000 can adopt a thrombus fragmentation knife, and the thrombus fragmentation knife can be a single-edge blade or a multi-edge blade. In addition, the thrombus fragmentation component 4000 can also adopt structures such as a thrombus fragmentation rod and a thrombus fragmentation piece.

[0056] The filter plug component 3000 is respectively connected to the inner core tube 1000 and the inner catheter 2000, and is transported to or withdrawn from the target blood vessel by means of the inner core tube 1000 and the inner catheter 2000. Moreover, the filter plug component 3000 also needs to be connected to the inner core tube 1000 and the inner catheter 2000, so that the filter plug cavity 3000a can communicate with the thrombus aspiration channel, and the crushed thrombus can be directly aspirated through the thrombus aspiration channel after being crushed. The filter plug component 3000 can be connected to the inner core tube 1000 and the inner catheter 2000 in a variety of ways. For example, the filter plug component 3000 can be movably sleeved outside the inner core tube 1000 through the filter plug cavity 3000a. The distal end of the filter plug component 3000 is connected to the inner core tube 1000, and the proximal end of the filter plug component 3000 is connected to the inner catheter 2000. The filter plug component 3000 has a deformation function, and the radial contour size of the filter plug component 3000 can be adjusted by using the axial relative movement between the inner core tube 1000 and the inner catheter 2000. The inner core tube 1000 has a through core tube inner cavity, and a guiding component 1000a can be provided at the distal end of the inner core tube 1000. The guiding component 1000a has a through guiding channel, and the guiding channel can communicate with the core tube inner cavity of the inner core tube 1000. At this time, the distal end of the filter plug component 3000 can be fixedly connected to the inner core tube 1000 through the guiding component 1000a. Moreover, a guiding silk thread can also pass through the guiding channel and the core tube inner cavity for guiding the implantation of the thrombus removal system into the target blood vessel.

[0057] The filter plug component 3000 is sleeved outside the inner core tube 1000 in such a way that the filter plug component 3000 can accommodate thrombus around the entire circumference of the outside of the inner core tube 1000. In addition, the filter plug component 3000 may not surround the entire circumference of the inner core tube 1000, but only a circumferential part of the inner core tube 1000. Therefore, as long as the filter plug cavity 3000a of the filter plug component 3000 is in communication with the thrombus aspiration channel, the aspiration of the pulverized thrombus through the thrombus aspiration channel after thrombus fragmentation can be achieved. Those skilled in the art can construct the specific structure of the filter plug component 3000 and the assembly manner between the filter plug component 3000, the inner core tube 1000, and the inner catheter 2000 according to actual requirements, and no specific limitation is made here.

[0058] In one embodiment, the distal end of the thrombus fragmentation component 4000 can be fixedly connected to the inner core tube 1000, and the proximal end of the thrombus fragmentation component 4000 is movably connected to the inner catheter 2000. At this time, the rotation of the inner core tube 1000 relative to the inner catheter 2000 can be used as a power source to drive the thrombus fragmentation component 4000 to rotate. At this time, the inner core tube 1000 and the guiding component 1000a can be arranged to be rotatable relative to each other circumferentially, but the axial relative movement between the inner core tube 1000 and the guiding component 1000a is restricted.

[0059] In addition, the rotation of the inner catheter 2000 relative to the inner core tube 1000 can also be used as a power source. In this embodiment, continue to refer to Figure 2 As shown, the distal end of the thrombus fragmentation component 4000 can be movably connected to the inner core tube 1000, and the proximal end of the thrombus fragmentation component 4000 can be fixedly connected to the inner catheter 2000. The distal end of the thrombus fragmentation component 4000 being movably connected to the inner core tube 1000 needs to ensure at least that the thrombus fragmentation component 4000 can rotate relative to the inner core tube 1000. Therefore, when the inner catheter 2000 drives the thrombus fragmentation component 4000 to rotate, it will not interfere with the inner core tube 1000. In one embodiment, the distal end of the thrombus fragmentation component 4000 can be provided with a rotational assembly element 4000a, and the rotational assembly element 4000a has a through assembly hole. The rotational assembly element 4000a is rotatably sleeved outside the inner core tube 1000 through the assembly hole.

[0060] Similarly, the distal end of the filter plug component 3000 is fixedly connected to the inner core tube 1000, and the proximal end of the filter plug component 3000 needs to be movably connected to the inner catheter 2000. Moreover, the movable connection between the proximal end of the filter plug component 3000 and the inner catheter 2000 needs to ensure at least relative rotation between the filter plug component 3000 and the inner catheter 2000. Since the axial relative movement between the inner core tube 1000 and the inner catheter 2000 can adjust the radial contour size of the filter plug component 3000, it is only necessary to limit the axial movement of the proximal end of the filter plug component 3000 relative to the inner catheter 2000. When the rotation of the inner catheter 2000 relative to the inner core tube 1000 drives the thrombus-breaking component 4000 to rotate, the rotation of the inner catheter 2000 will not interfere with the filter plug component 3000.

[0061] Continue to refer to Figure 2 As shown, the inner catheter 2000 or the filter plug component 3000 may be provided with a rotation limiting structure 3100, and the proximal end of the filter plug component 3000 is circumferentially movably connected to the inner catheter 2000 through the rotation limiting structure 3100. The rotation limiting structure 3100 can be used to limit the axial movement of the proximal end of the filter plug component 3000 relative to the inner catheter 2000 and allow the filter plug component 3000 to rotate circumferentially relative to the inner catheter 2000. In one embodiment, the rotation limiting structure 3100 may include an annular limiting groove formed on the outer wall of the inner catheter 2000 and an annular limiting portion provided at the proximal end of the filter plug component 3000. Alternatively, the annular limiting groove may also be formed on the inner catheter 2000, and the annular limiting portion may also be provided on the filter plug component 3000, as long as the annular limiting portion and the annular limiting groove are rotationally assembled. The rotational assembly of the annular limiting portion and the annular limiting groove can enable the annular limiting portion to rotate circumferentially relative to the inner catheter 2000 and limit the axial movement of the annular limiting portion relative to the inner catheter 2000. In addition, the rotation limiting structure 3100 can also be constructed by other cooperating components, as long as the rotation of the inner catheter 2000 does not interfere with the filter plug component 3000, and at the same time, the radial contour size of the filter plug component 3000 can be adjusted by the axial relative movement between the inner core tube 1000 and the inner catheter 2000. Those skilled in the art can adopt other forms such as a limiting ring and a limiting track according to actual needs to achieve the same technical purpose, and no specific limitation is made here.

[0062] Regarding the construction of the annular limiting portion and the annular limiting groove, refer to Figure 3As shown, in one embodiment, the proximal end of the filter plug component 3000 may have a filter plug pipe orifice 3000b, which can be used to movably sleeved outside the annular limiting groove, and the filter plug pipe orifice 3000b constitutes an annular limiting portion. The distal end of the inner catheter 2000 may be provided with an attachment pipe 3100a, which has a through attachment inner cavity 3100a1. The outer wall of the proximal region of the attachment pipe 3100a is fixedly connected to the inner wall of the inner catheter 2000, so that the attachment inner cavity 3100a1 of the attachment pipe 3100a is communicated with the catheter inner cavity of the inner catheter 2000. The proximal end of the thrombus fragmentation component 4000 has a thrombus fragmentation pipe orifice 4000b, and the outer wall of the distal region of the attachment pipe 3100a is fixedly connected to the inner wall of the thrombus fragmentation pipe orifice 4000b of the thrombus fragmentation component 4000. Since both the inner catheter 2000 and the thrombus fragmentation pipe orifice 4000b have a certain wall thickness, refer to Figure 3 As shown, the outer wall of the attachment pipe 3100a can form an annular limiting groove with the wall thicknesses of the inner catheter 2000 and the thrombus fragmentation pipe orifice 4000b.

[0063] Refer to Figure 4 and Figure 5 As shown, a filter plug region 3000c and a hollowed-out region 3000d can be formed on the surface of the filter plug component 3000. The filter plug component 3000 can be deformed and can be switched between a contracted state and a deployed state through its deformation function. Before the operation, it can be presented in a contracted state and retracted in the sheath inner cavity of the outer sheath tube 5000. During the operation, it can be deployed in the target blood vessel and presented in a deployed state with a suitable radial dimension. The hollowed-out region 3000d has a relatively large hollowed-out window, which can apply a force to the thrombus during the deployment process, embed into the thrombus, and pass through the thrombus with its hollowed-out window to accommodate the thrombus in the target blood vessel in the filter plug cavity 3000a.

[0064] Since the filter plug component 3000 is retracted in the direction from the distal end to the proximal end during the thrombus removal process, the filter plug region 3000c is arranged in the distal direction of the hollowed-out region 3000d. Filter plug micropores are opened in the filter plug region 3000c, and the size design of the filter plug micropores needs to meet the requirement that blood can pass through, but the fragmented thrombus is prohibited from passing through. Therefore, the specific size of the filter plug micropores can be adaptively constructed according to the expected degree of thrombus fragmentation. For example, the diameter of the filter plug micropores can be designed between 10 μm and 1 mm. During the retraction process of the filter plug component 3000, the distal filter plug region 3000c can filter out the fragmented thrombus in the blood, capture the fragmented thrombus in the filter plug cavity 3000a of the filter plug component 3000, and be pulled out of the body as the filter plug component 3000 is retracted.

[0065] The filter plug component 3000 can adopt various suitable structures such as a stent structure, a mesh structure, etc., so that the filter plug component 3000 has an appropriate degree of deformation ability, which can not only closely adhere to the inner wall of the target blood vessel, facilitating the scraping of blood clots, but also avoid applying too much force to the inner wall of the target blood vessel and damaging the target blood vessel on the surface.

[0066] For example, refer to Figure 4 As shown, the filter plug component 3000 can adopt a mesh structure woven from metal round wires, and a dense mesh structure can be woven in the distal region of the filter plug component 3000 to form a filter plug region 3000c with filter plug micropores. Similarly, in the proximal region, multiple strands of wires can be converged and woven into a large mesh hole structure, and the large mesh hole structure can form a hollow region 3000d with a larger hollow window. Or refer to Figure 5 As shown, the filter plug component 3000 can include a deformable frame body 3000e, and the deformable frame body 3000e is used as the internal skeleton of the filter plug component 3000. The internal space of the deformable frame body 3000e can form a filter plug cavity 3000a. A film body 3000f with filter plug micropores can be arranged in the distal region of the deformable frame body 3000e. After the film body 3000f covers the distal region of the deformable frame body 3000e, the filtering performance of the distal region can be changed to form a filter plug region 3000c with filter plug micropores. The film body 3000f can adopt a polymer microporous structure. Other regions of the deformable frame body 3000e that are not covered by the film body 3000f and are exposed outside the film body 3000f can form larger hollow windows based on the frame form of the deformable frame body 3000e to constitute the hollow region 3000d.

[0067] The outer sheath tube 5000 has a through sheath lumen. The outer sheath tube 5000 is movably sleeved outside the inner catheter 2000. The outer sheath tube 5000 can adopt a composite structure of multiple layers of materials, or the outer sheath tube 5000 can also be a single material. The outer sheath tube 5000 can axially move outside the inner catheter 2000 to constrict or release the filter plug component 3000 and the thrombus fragmentation component 4000. Therefore, both the filter plug component 3000 and the thrombus fragmentation component 4000 can have the ability to deform. In the contracted state, they present a structure similar to a tube body, and the contracted size can be suitable for being constricted in the sheath lumen of the outer sheath tube 5000. The deformation of the filter plug component 3000 or the thrombus fragmentation component 4000 can be controlled based on an externally applied force or based on its own shape memory deformation. For example, the relative movement between the inner catheter 2000 and the inner core tube 1000 controls the adjustment of the radial contour size of the filter plug component 3000. Or, both the filter plug component 3000 and the thrombus fragmentation component 4000 can be made of shape memory metal. When wrapped by the outer sheath tube 5000, the filter plug component 3000 and the thrombus fragmentation component 4000 contract due to the force. When the wrapping of the outer sheath tube 5000 is removed, the filter plug component 3000 and the thrombus fragmentation component 4000 can return to the expanded state due to their shape memory ability. As long as the filter plug component 3000 and the thrombus fragmentation component 4000 are separated from the constriction of the outer sheath tube 5000, they can be in the expanded state as required. The filter plug component 3000 fits the inner wall of the target blood vessel in the expanded state, and the thrombus fragmentation component 4000 increases the contact degree with the thrombus in the expanded state, which is beneficial to crushing the thrombus.

[0068] Continue to refer to Figure 1 As shown, a core tube connection element 1000b can be provided at the proximal end of the inner core tube 1000. The core tube connection element 1000b has a through core tube connection hole, and the core tube connection hole communicates with the core tube lumen. Therefore, before the operation, the core tube lumen can be emptied through the core tube connection hole of the core tube connection element 1000b.

[0069] A catheter connection element 2000a can be provided at the proximal end of the inner catheter 2000. The catheter connection element 2000a has a through catheter connection hole. The catheter connection element 2000a is sleeved outside the inner core tube 1000 through the catheter connection hole. The proximal and distal ends of the catheter connection element 2000a are sealed with the inner core tube 1000. The catheter connection element 2000a is provided with a catheter drainage hole communicating with the catheter connection hole. The catheter drainage hole communicates with the thrombus aspiration channel through the catheter connection hole. The thrombus aspiration channel is used to be connected to a negative pressure device 6000 through the catheter drainage hole.

[0070] For example, the catheter connection element 2000a can adopt a Y-shaped structure with two branches, and the catheter connection hole and the catheter drainage hole can be led out through the two branches of the catheter connection element 2000a respectively. The negative pressure device 6000 is communicated with the thrombus aspiration channel through the catheter drainage hole. When the negative pressure device 6000 is started, a suction negative pressure can be provided to the thrombus aspiration channel to suck the pulverized thrombus out of the thrombus aspiration channel. Moreover, the thrombus aspiration channel can be emptied through the catheter drainage hole before the operation.

[0071] The proximal end of the outer sheath 5000 can be provided with a sheath connection element 5000a. The sheath connection element 5000a has a through sheath connection hole. The sheath connection element 5000a is sleeved outside the inner catheter 2000 through the sheath connection hole. The proximal end and the distal end of the sheath connection element 5000a are sealed with the inner catheter 2000. The sheath connection element 5000a is provided with a sheath drainage hole communicating with the sheath connection hole. The sheath drainage hole is communicated with the tube layer gap between the inner wall of the outer sheath 5000 and the outer wall of the inner catheter 2000 through the sheath connection hole. The tube layer gap between the inner wall of the outer sheath 5000 and the outer wall of the inner catheter 2000 can be emptied through the sheath drainage hole before the operation.

[0072] The negative pressure device 6000 is communicated with the thrombus aspiration channel. The negative pressure device 6000 can be used to provide negative pressure to the thrombus aspiration channel. For example, the negative pressure device 6000 can adopt a suction pump or the like, and is communicated with the thrombus aspiration channel by means of an adapted pipeline. When the suction pump is started, a negative pressure can be formed to suck the pulverized thrombus in the filter thrombus space out of the thrombus aspiration channel.

[0073] The driving device is connected to the inner catheter 2000. During the process of removing thrombus, the driving device is used to drive the inner catheter 2000 to rotate relative to the inner core tube 1000, so that the rotation action of the inner catheter 2000 relative to the inner core tube 1000 can drive the thrombus fragmentation component 4000 to rotate. The mechanical force is applied to the thrombus in the target blood vessel by the rotation of the thrombus fragmentation component 4000, and the thrombus is fragmented by using the mechanical force, and the thrombus is fragmented from the original large block structure into a large number of small block structures.

[0074] The driving device can adopt various power source forms and various power transmission methods. For example, manual driving or motor driving, etc., and then the power source is applied to the inner catheter 2000 through various transmission methods such as gear transmission, lead screw transmission, and belt transmission to drive the inner catheter 2000 to rotate relative to the inner core tube 1000. In one embodiment, the driving device can include a driving motor 7100 and a gear assembly 7200. The gear assembly 7200 includes a driving gear 7200a and a driven gear 7200b. The driving gear 7200a is connected to the output end of the driving motor 7100, and the rotation of the driving motor 7100 can drive the driving gear 7200a to rotate.

[0075] When the rotation of the inner core tube 1000 relative to the inner catheter 2000 serves as the power source, the driven gear 7200b is fixed on the inner core tube 1000. By meshing the driving gear 7200a with the driven gear 7200b, the driven gear 7200b can be driven to rotate, thereby driving the inner core tube 1000 to rotate relative to the inner catheter 2000. When the rotation of the inner catheter 2000 relative to the inner core tube 1000 serves as the power source, the driven gear 7200b is fixed on the inner catheter 2000. By meshing the driving gear 7200a with the driven gear 7200b, the driven gear 7200b can be driven to rotate, thereby driving the inner catheter 2000 to rotate relative to the inner core tube 1000. The number of driven gears 7200b can be one or more. For example, two, three or other numbers of driven gears 7200b are provided, and different driven gears 7200b are arranged at different axial positions of the inner catheter 2000. Therefore, when the inner core tube 1000 is kept stationary, the driving gear 7200a can be in transmission engagement with different driven gears 7200b axially on the inner catheter 2000, so that when different driven gears 7200b are engaged with the driving gear 7200a, the inner catheter 2000 can be kept at different axial positions relative to the inner core tube 1000. By utilizing the cooperation of different axial positions of the inner catheter 2000 and the inner core tube 1000, the filter bolt component 3000 can be adjusted to different radial contour dimensions to adapt to different target blood vessel sizes.

[0076] In some other embodiments, different driven gears 7200b can also be provided with different circumferential pitches, so that when the driving gear 7200a is engaged with different driven gears 7200b, different transmission ratios can also be formed, thereby adjusting the rotation speed of the filter bolt component 3000. A positioning key can be provided on the driven gear 7200b, and the positioning key is used to circumferentially fix the driven gear 7200b to the inner catheter 2000, and at the same time ensure that the driven gear 7200b can axially slide relative to the inner catheter 2000.

[0077] When performing the thrombus removal operation on the target blood vessel, the tube layer gap between the outer sheath tube 5000 and the inner catheter 2000, the thrombus suction channel between the inner catheter 2000 and the inner core tube 1000, and the core tube lumen of the inner core tube 1000 can be emptied first. The outer sheath tube 5000 and other components that need to be infiltrated are infiltrated with physiological saline.

[0078] The present application provides a thrombus removal method based on a thrombus removal system. The thrombus removal method includes the following steps: capturing a target object into the thrombus filtration cavity 3000a through the thrombus filtration component 3000; controlling the relative rotation of the inner core tube and the inner catheter, thereby driving the thrombus fragmentation component to rotate in the thrombus filtration cavity 3000a of the thrombus filtration component 3000 to fragment the target object in the thrombus filtration cavity 3000a; and sucking out the fragmented target object through the thrombus suction channel. Specifically, both the thrombus filtration component 3000 and the thrombus fragmentation component 4000 are in a contracted state and are bundled in the outer sheath tube 5000. The thrombus removal system punctures the blood vessel and is delivered to the target blood vessel. When the thrombus removal system reaches the position of the thrombus, the outer sheath tube 5000 is retracted to release the thrombus filtration component 3000 and the thrombus fragmentation component 4000, so that the thrombus filtration component 3000 and the thrombus fragmentation component 4000 are in an expanded state. The thrombus filtration component 3000 adheres to the inner wall of the target blood vessel and houses the thrombus in the thrombus filtration cavity 3000a.

[0079] Slowly retract the entire thrombus removal system, and use the thrombus filtration component 3000 to separate the thrombus from the target blood vessel. During this process, use the rotation of the inner catheter 2000 to drive the thrombus fragmentation component 4000 to rotate in the thrombus filtration cavity 3000a to fragment the thrombus. At the same time, apply negative pressure to the thrombus suction channel to suck out the fragmented thrombus. Therefore, the three actions of separating the thrombus from the target blood vessel, fragmenting the thrombus, and sucking out the fragmented thrombus can be carried out simultaneously. This process can quickly and efficiently remove the thrombus at one time.

[0080] During the process of slowly retracting the thrombus removal system, the axial movement of the inner catheter 2000 relative to the inner core tube 1000 can be locked to keep the radial contour size of the thrombus filtration component 3000 in an unchanged state. For example, the driving gear 7200a can be meshed with different driven gears 7200b. When the driving gear 7200a is meshed with one driven gear 7200b, the thrombus filtration component 3000 can be kept in different radial contour sizes unchanged to adapt to different target blood vessel sizes. Or during the slow retraction process, the inner catheter 2000 can be allowed to move relative to the inner core tube 1000, so that the radial contour size of the thrombus filtration component 3000 can change in real time, forming an adaptive mutual extrusion with the inner wall of the target blood vessel, and adapting and adjusting the radial contour size of the thrombus filtration component 3000 according to the change of the target blood vessel.

[0081] After the thrombus removal is completed, push the outer sheath tube 5000 to continue to bundle the thrombus filtration component 3000 and the thrombus fragmentation component 4000 in the outer sheath tube 5000, retract the thrombus removal system, and withdraw it from the body.

[0082] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the various technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as falling within the scope described in this specification.

[0083] The above-described embodiments merely represent several implementation manners of the present application. The description thereof is relatively specific and detailed, but it should not be construed as a limitation to the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. A thrombus removal system, characterized in that, The thrombus removal system includes: An inner core tube; An inner catheter, the inner catheter having a through catheter lumen, the inner catheter movably sleeved outside the inner core tube, and the tube layer gap between the inner wall of the inner catheter and the outer wall of the inner core tube forms a thrombus suction channel; A thrombus filter component, the thrombus filter component being connected to the inner core tube and the inner catheter respectively, the thrombus filter component having a thrombus filter cavity, and the thrombus filter cavity communicating with the thrombus suction channel; A thrombus fragmentation component, the thrombus fragmentation component being connected to the inner core tube or the inner catheter, and the thrombus fragmentation component being located in the thrombus filter cavity of the thrombus filter component.

2. The thrombus removal system according to claim 1, characterized in that, The thrombus removal system includes: An outer sheath tube, the outer sheath tube having a through sheath lumen, the outer sheath tube movably sleeved outside the inner catheter for bundling the thrombus filter component and the thrombus fragmentation component; and / or, A negative pressure device, the negative pressure device communicating with the thrombus suction channel; and / or, A driving device, the driving device being used to drive the inner catheter to rotate relative to the inner core tube, the driving device including a driving motor and a gear assembly, the gear assembly including a driving gear and a driven gear that mesh with each other, the driving gear being connected to the output end of the driving motor, and the driven gear being fixed on the inner catheter.

3. The thrombus removal system according to claim 1, wherein, The distal end of the thrombus fragmentation component is movably connected to the inner core tube, and the proximal end of the thrombus fragmentation component is fixedly connected to the inner catheter; and / or, The thrombus filter component is movably sleeved outside the inner core tube through the thrombus filter cavity, the distal end of the thrombus filter component is fixedly connected to the inner core tube, the proximal end of the thrombus filter component is movably connected to the inner catheter, the thrombus filter component has a deformation function, and the axial relative movement between the inner core tube and the inner catheter is used to adjust the radial contour dimension of the thrombus filter component.

4. The thrombus removal system according to claim 3, characterized in that, The distal end of the thrombus fragmentation component is provided with a rotating assembly element, the rotating assembly element having a through assembly hole, and the rotating assembly element is rotatably sleeved outside the inner core tube through the assembly hole; and / or, At least one of the inner catheter and the thrombus filter component is provided with a rotation limiting structure, the proximal end of the thrombus filter component is movably connected to the inner catheter through the rotation limiting structure, the rotation limiting structure is used to limit the axial movement of the proximal end of the thrombus filter component relative to the inner catheter, and allows the inner catheter to rotate circumferentially relative to the thrombus filter component; and / or, The inner core tube has a through core tube lumen, the distal end of the inner core tube is provided with a guiding component, the guiding component having a through guiding channel, the guiding channel communicating with the core tube lumen of the inner core tube, and the distal end of the thrombus filter component is fixedly connected to the inner core tube through the guiding component.

5. The thrombus removal system according to claim 4, characterized in that, The rotation limiting structure includes an annular limiting groove formed on the outer wall of the inner catheter and an annular limiting portion provided at the proximal end of the thrombus filter component, and the annular limiting portion is rotationally assembled with the annular limiting groove, so that the inner catheter can rotate circumferentially relative to the annular limiting portion and limits the axial movement of the annular limiting portion relative to the inner catheter.

6. The thrombus removal system according to claim 5, wherein, The distal end of the inner catheter is provided with an attachment tube, the attachment tube has a through attachment inner cavity, the outer wall of the proximal region of the attachment tube is fixedly connected to the inner wall of the inner catheter, so that the attachment inner cavity of the attachment tube communicates with the catheter inner cavity of the inner catheter, the proximal end of the thrombus fragmentation component has a thrombus fragmentation pipe orifice, the outer wall of the distal region of the attachment tube is fixedly connected to the inner wall of the thrombus fragmentation pipe orifice of the thrombus fragmentation component, and the outer wall of the attachment tube is used to form the annular limiting groove; and / or, The proximal end of the filter thrombus component has a filter thrombus pipe orifice, and the filter thrombus pipe orifice is movably sleeved outside the annular limiting groove for forming the annular limiting portion.

7. The thrombus removal system according to claim 1, wherein, The surface of the filter thrombus component includes a filter thrombus region and a hollowed-out region, the filter thrombus region is located in the distal direction of the hollowed-out region, filter thrombus micropores are opened in the filter thrombus region, and the diameter of the filter thrombus micropores is between 10 μm and 1 mm.

8. The thrombus removal system according to claim 7, characterized in that, The filter thrombus component includes a deformable frame body, and the inside of the deformable frame body forms the filter thrombus cavity; a film body with the filter thrombus micropores opened is arranged in the distal region of the deformable frame body for forming the filter thrombus region; other regions of the deformable frame body exposed outside the film body form the hollowed-out region.

9. The thrombus removal system according to claim 2, wherein The proximal end of the inner core tube is provided with a core tube connection element, the core tube connection element has a through core tube connection hole, and the core tube connection hole communicates with the core tube inner cavity; and / or, The proximal end of the inner catheter is provided with a catheter connection element, the catheter connection element has a through catheter connection hole, the catheter connection element is sleeved outside the inner core tube through the catheter connection hole, the proximal end and the distal end of the catheter connection element are sealed with the inner core tube, the catheter connection element is provided with a catheter drainage hole communicating with the catheter connection hole, the catheter drainage hole communicates with the thrombus suction channel through the catheter connection hole, and the thrombus suction channel is used to be connected with the negative pressure device through the catheter drainage hole; and / or, The proximal end of the outer sheath tube is provided with a sheath tube connection element, the sheath tube connection element has a through sheath tube connection hole, the sheath tube connection element is sleeved outside the inner catheter through the sheath tube connection hole, the proximal end and the distal end of the sheath tube connection element are sealed with the inner catheter, the sheath tube connection element is provided with a sheath tube drainage hole communicating with the sheath tube connection hole, and the sheath tube drainage hole communicates with the tube layer gap between the inner wall of the outer sheath tube and the outer wall of the inner catheter through the sheath tube connection hole.

10. A thrombus removal method for the thrombus removal system according to any one of claims 1-9, characterized in that, The thrombus removal method includes the following steps: Capturing a target object into the filter thrombus cavity through the filter thrombus component; Controlling the relative rotation of the inner catheter and the inner core tube, and further driving the thrombus fragmentation component to rotate in the filter thrombus cavity of the filter thrombus component to crush the target object in the filter thrombus cavity; Sucking out the crushed target object through the thrombus suction channel.

Images