A vascular thrombectomy frame
By designing a vascular thrombectomy frame with a mesh or cage-like structure with ribs, and utilizing a narrowed portion and a three-dimensional array structure, the problem of insufficient suction in peripheral blood vessels by existing devices is solved, achieving efficient thrombus removal and reducing vascular damage.
Patent Information
- Application Number
- CN202410965918.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2023-09-14
- Filing Date
- 2024-07-18
- Publication Date
- 2025-09-30
- Estimated Expiration
- 2044-07-18
AI Technical Summary
Existing thrombus removal devices have the problem of insufficient suction in peripheral blood vessels, making it difficult to effectively remove acute and subacute thrombi, and causing significant damage to the vascular endothelium.
A vascular thrombectomy frame is designed, which adopts a mesh tube or cage-like structure with ribs. A narrow portion is set between the distal and proximal ends. The narrow portion divides the thrombectomy frame into multiple grid sections. The ribs form a narrow slit structure or an angle structure, which can capture thrombi and improve capture efficiency through the gradually enlarging outer contour and three-dimensional array.
It improves the efficiency of thrombus removal, reduces damage to the vascular endothelium, and can effectively capture and remove thrombi and prevent thrombus escape.
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Figure CN118766546B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical equipment, and in particular to a vascular thrombectomy frame. Background Art
[0002] Peripheral arterial disease (PAD) refers to disease of the arteries outside the heart or brain. It primarily involves the formation of atherosclerotic plaques in peripheral arteries, such as the common iliac, femoral, radial, and brachial arteries, resulting in vascular stenosis greater than 50%. PAD has serious consequences, including intermittent claudication, amputation, severe hypertension and renal failure, as well as an increased incidence of myocardial infarction, stroke, and cardiac death. PAD is the third leading cause of atherosclerotic vascular disease after coronary artery disease and stroke. Treatment options for peripheral arterial disease vary. For acute lower limb thrombosis, interventional surgery is the current mainstream procedure, but the devices used are relatively limited, primarily involving drug thrombolysis. Acute mesenteric ischemia (AMI), also known as "intestinal stroke," presents an insidious onset and rapid progression. Symptoms and signs often mismatch, making misdiagnosis and missed diagnosis a common occurrence, with a mortality rate of 20-50%. While surgery is the primary treatment option, interventional surgery remains an alternative.
[0003] Peripheral venous disease is divided into two categories: chronic venous insufficiency and venous thromboembolism. Chronic venous insufficiency primarily includes venous valve insufficiency, varicose veins, and sequelae of venous thrombosis. Venous thromboembolism, on the other hand, primarily includes deep vein thrombosis (DVT) and pulmonary thromboembolism (PE), with PE primarily caused by DVT. DVT is a common and frequently occurring clinical condition, affecting approximately 1 in 1,000 people annually. Its primary clinical symptoms include swelling and pain in the affected limb, severely impacting patients' ability to function and function. In severe cases, pulmonary embolism (PE) may also occur, making it a leading cause of sudden death. Thrombolysis and anticoagulation alone, along with surgery, are the mainstays of treatment for acute lower extremity deep vein thrombosis. However, due to the poor efficacy and high recurrence rate of thrombolysis alone, surgery has replaced it. Combined thrombectomy procedures, such as catheter-directed thrombolysis (CDT), surgical thrombectomy, and percutaneous mechanical thrombectomy (PMT), have been developed. The Angio Jet is the most commonly used thrombectomy catheter in China.
[0004] In the prior art, Medtronic's CN201380069871 and CN201310471114 describe a self-expanding device with multiple grids at the proximal and distal ends, with an opening at the distal end, which is now a common treatment structure for neurointerventional stents; CN202110845847 describes a thrombectomy device with adjustable diameter and length, including a controller, a delivery guide wire, and a plurality of cage stent units. The controller has a gripping portion and a control button disposed in the gripping portion. The cage units can be controlled uniformly, so that one thrombectomy device can meet the needs of blood vessels of various diameters; CN202310700501 describes a A double-layer thrombectomy stent includes an outer stent, the proximal end of which is connected to a push tube, and an inner braided microfilter connected to the inner side of the distal end of the outer stent. This structure can effectively prevent thrombus escape. CN201711280212 describes a self-expanding tubular network structure composed of multiple interconnected mesh units. The surface is wavy, with a small contact area with the blood vessel wall and low metal coverage. This minimizes damage to the vascular endothelium during thrombectomy and reduces friction between the thrombus and the blood vessel wall, making it easier to remove the thrombus. CN202020677733 describes a thrombectomy assembly and thrombectomy device for iliac vein thrombus removal. The thrombectomy assembly includes a radially elastically expandable and coaxially arranged thrombus isolation filter and a thrombus capture basket. The thrombus isolation filter and thrombus capture basket are fixedly connected, allowing for effective thrombus removal. CN202010216583 describes a filter assembly and thrombus aspiration assembly for pulmonary embolism thrombus removal. The filter assembly includes a radially expandable, coaxially arranged thrombus-disintegrating filter, a first isolation filter, and a second isolation filter; the thrombus-disintegrating filter is positioned between the first and second isolation filters. The thrombus aspiration assembly includes a thrombus aspiration tube, a thrombus delivery tube, a thrombus aspirator, and a connector with a hollow channel, effectively removing large thrombi.
[0005] The thrombectomy stents currently used in the market each have their own advantages and disadvantages. For example, CN201380069871 is used for intracranial blood vessels. The stent is relatively soft as a whole and is suitable for thrombectomy of acute thrombi, and cerebral infarction is often an acute thrombus; CN202010216583 is a clinical product under development, mainly used for pulmonary embolism (PE). It has a disc structure, which can break up the thrombus of pulmonary infarction and thus perform thrombectomy, but the stent is too large and too hard, which limits its further application in other blood vessels; peripheral thrombi are often a mixture of acute thrombi and subacute and chronic thrombi, and the amount of thrombi is large. Existing catheter aspiration and the like have the defect of insufficient aspiration. Based on this, a new solution is urgently needed to solve this problem. Summary of the Invention
[0006] The purpose of the present invention is to provide a vascular thrombus removal frame to solve the problems existing in the above-mentioned prior art and improve the efficiency and effect of thrombus removal.
[0007] To achieve the above object, the present invention provides the following solutions:
[0008] The present invention provides a vascular thrombus removal frame, comprising a thrombus removal frame having a distal end and a proximal end, wherein the thrombus removal frame is a mesh tube-like or cage-like structure with ribs; a plurality of spaced-apart narrowing portions are provided between the distal end and the proximal end of the thrombus removal frame; the narrowing portions are formed by the lateral narrowing of the thrombus removal frame; the narrowing portions divide the outer contour frame of the thrombus removal frame having the function of stripping or capturing thrombi into multiple sections; the ribs forming the narrowing portions have a plurality of rib pairs tending to intersect; the narrow slit structure or angle structure formed by the rib pairs can clamp a thrombus clot that tends to move away from the functional outer contour frame.
[0009] Preferably, the narrowed portion divides the thrombus removal frame into a plurality of mesh portions for stripping or capturing thrombi; each of the plurality of mesh portions has an outer contour that gradually increases in size from the proximal end to the distal end.
[0010] Preferably, the narrowed portion is provided with a first pair of ribs and a second pair of ribs whose longitudinal projections do not overlap.
[0011] Preferably, the thrombus removal frame has narrowed portions with different degrees of narrowing.
[0012] The present invention provides a vascular thrombus removal frame, comprising a thrombus removal frame having a distal end and a proximal end, wherein the thrombus removal frame is a mesh tube-shaped or cage-shaped structure with ribs; a narrowing portion formed by the thrombus removal frame being narrowed laterally is provided between the distal end and the proximal end of the thrombus removal frame; the narrowing portion divides the thrombus removal frame into a plurality of mesh portions for stripping or capturing thrombi; the plurality of mesh portions have an outer profile that gradually increases from the proximal end to the distal end; the ribs forming the narrowing portion have a plurality of pairs of connected ribs to form a plurality of node units; the plurality of node units form a three-dimensional array capable of laterally intercepting free thrombi.
[0013] Preferably, along the direction from the proximal end to the distal end, the latter mesh portion can further peel off or capture residual thrombus relative to the former mesh portion.
[0014] The present invention provides a vascular thrombus removal frame, comprising a thrombus removal frame having a distal end and a proximal end, the thrombus removal frame being a mesh tube-shaped or cage-shaped structure with ribs; a narrowing portion formed by the thrombus removal frame being laterally narrowed is provided between the distal end and the proximal end of the thrombus removal frame; the narrowing portion divides the thrombus removal frame into a first grid portion and a second grid portion for stripping or capturing thrombi, and the second grid portion can further strip or capture residual thrombi relative to the first grid portion; the ribs forming the thrombus removal frame have several pairs of connected ribs and form several first node units; the ribs forming the narrowing portion have several pairs of connected ribs and form several second node units; the several second node units form a three-dimensional array capable of laterally intercepting free thrombi.
[0015] Preferably, the first grid portion and the second grid portion of the thrombus removal frame both have outer contours that gradually increase in size from the proximal end to the distal end.
[0016] Preferably, a plurality of the ribs at the proximal end section of the thrombus removal frame have a wave-shaped structure.
[0017] Preferably, the proximal end of the thrombus removal frame has an open structure.
[0018] Preferably, the proximal end of the thrombus removal frame is connected to the manipulation member via a connecting rib.
[0019] Preferably, the proximal end of the thrombus removal frame has multiple ribs, which are connected to the manipulation component by bundling.
[0020] Compared with the prior art, the present invention has achieved the following technical effects:
[0021] The vascular thrombus removal frame provided by the present invention is provided with a narrow portion, which is used to accommodate and clamp the thrombus, thereby improving the efficiency and effect of thrombus removal.
[0022] Compared with traditional stents, the blank surface area of the stent with a narrowed portion is much larger than that of traditional stents, which can reduce damage to the vascular endothelium. Furthermore, the mesh portion has an outer contour that gradually increases from the proximal to the distal end, which can further improve the efficiency and effect of thrombus removal. BRIEF DESCRIPTION OF THE DRAWINGS
[0023] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.
[0024] Figure 1 This is a real picture of a simulated thrombus removal process using the vascular thrombectomy frame provided by an embodiment of the present invention;
[0025] Figure 2 A schematic structural diagram of a vascular thrombectomy frame provided in an embodiment of the present invention;
[0026] Figure 3 for Figure 2 Front view (from distal to proximal);
[0027] Figure 4 for Figure 2 Rear view;
[0028] Figure 5 for Figure 2 Side view of
[0029] Figure 6 A schematic structural diagram of a vascular thrombectomy frame, a hypotube, and a control component provided in an embodiment of the present invention;
[0030] Figure 7 A schematic diagram of the structure of a thrombus removal device using the vascular thrombus removal device provided by an embodiment of the present invention;
[0031] Figure 8 A schematic diagram of the positional relationship between the first rib pair and the second rib pair in one embodiment;
[0032] Figure 9 A schematic diagram of the positional relationship between the first rib pair, the second rib pair, and the third rib pair in one embodiment;
[0033] Figure 10 A schematic diagram of the positional relationship between the first rib pair, the second rib pair, and the third rib pair in one embodiment;
[0034] Figure 11 for Figure 3 A magnified view of the local H in the middle;
[0035] Figure 12 is a structural diagram of a corner unit;
[0036] Figure 13 Schematic diagram of the structure of the vascular thrombectomy frame in the unilateral stenosis scheme;
[0037] Figure 14 It is a structural diagram of the hanging area;
[0038] Figure 15 A schematic diagram of the longitudinal distribution of the first node, the second node, and the third node in one embodiment;
[0039] Figure 16 It is the structural diagram of the node unit;
[0040] Figure 17 for Figure 4Enlarged view of the local L in the middle;
[0041] Figure 18 A schematic diagram of the longitudinal distribution of the first mesh, the second mesh, the third mesh, and the fourth mesh in one embodiment;
[0042] Figure 19 A schematic diagram of a proximal section of one embodiment of an introduction structure;
[0043] Figure 20 This is a schematic diagram of the import structure of one embodiment;
[0044] Figure 21 A schematic diagram of the positional relationship between the introduction structure and the elliptical opening in one embodiment;
[0045] Figure 22 A schematic structural diagram of the proximal end section of a vascular thrombectomy stent provided in an embodiment of the present invention;
[0046] Figure 23 A partial schematic diagram of a V-shaped hanging member in a vascular thrombectomy frame provided by an embodiment of the present invention;
[0047] Figure 24 It is a structural diagram of a V-shaped hanging component;
[0048] Figure 25 Another embodiment of the present invention provides a vascular thrombectomy frame with a bundled structure;
[0049] Figure 26 A schematic diagram of the structure of a vascular thrombectomy stent provided by an embodiment of the present invention, wherein the node unit on the narrow portion is closest to the stent axis;
[0050] Figure 27 for Figure 26 AA sectional view;
[0051] Figure 28 for Figure 26 BB cross-sectional view;
[0052] Figure 29 for Figure 26 CC sectional view;
[0053] Figure 30 A schematic structural diagram of a vascular thrombectomy stent provided by an embodiment of the present invention, wherein the node units on the narrowed portion are not close to the axis of the stent;
[0054] Figure 31 for Figure 30 AA sectional view;
[0055] Figure 32 for Figure 30 BB cross-sectional view;
[0056] Figure 33 for Figure 30 CC sectional view;
[0057] Figure 34 A schematic structural diagram of a vascular thrombectomy frame with a first functional frame and a second functional frame of equal diameter provided by an embodiment of the present invention;
[0058] Figure 35 for Figure 34 AA sectional view;
[0059] Figure 36 for Figure 34 BB cross-sectional view;
[0060] Figure 37 for Figure 34 CC sectional view;
[0061] Figure 38 A schematic structural diagram of a vascular thrombectomy frame having the same diameter as the first functional frame, the second functional frame, and the third functional frame provided in an embodiment of the present invention;
[0062] Figure 39 A schematic diagram of a partial structure of a vascular thrombectomy frame with unchanged diamond-shaped grid size provided by an embodiment of the present invention;
[0063] Figure 40 A schematic diagram of a partial structure of a vascular thrombectomy frame with a diamond-shaped mesh having a gradient size provided by an embodiment of the present invention;
[0064] Figure 41 A schematic structural diagram of a vascular thrombectomy device provided in an embodiment of the present invention;
[0065] Figure 42 for Figure 41 Schematic diagram of the structure of the embolectomy frame;
[0066] Figure 43 for Figure 41 A partial enlarged view of
[0067] Figure 44 for Figure 41 Schematic diagram of the structure of the hypotube;
[0068] Figure 45 A half-section view of the connection between the control member and the connecting reinforcement;
[0069] Figure 46 A schematic structural diagram of a thrombus removal system provided in an embodiment of the present invention;
[0070] Figure 47 for Figure 46 A schematic diagram of the structure of the thrombus removal frame, which is manufactured through a weaving process;
[0071] In the figure: 1-narrowed portion; 2-rib; 3-distal end of the thrombectomy frame; 4-proximal end of the thrombectomy frame; 5-connecting rib; 100-thrombectomy frame; 200-hypotube; 300-manipulating member; 31-filling hole; 32-slot hole; 400-developing element; 500-suction catheter; 21-first rib pair; 22-second rib pair; 23-corner unit; 24-hooking area; 25-node unit; 26-third rib pair; 27-grid portion; 110-first narrowed portion; 120-second narrowed portion; 610-third First functional frame; 620 - second functional frame; 630 - third functional frame; 251 - first node; 252 - second node; 253 - third node; 631 - clustering portion; 710 - first mesh; 720 - second mesh; 730 - third mesh; 740 - fourth mesh; 8 - introduction structure; 810 - first corrugated member; 820 - second corrugated member; 830 - third corrugated member; 840 - corrugated grid unit; 9 - elliptical opening; 910 - proximal end of the elliptical opening; 920 - distal end of the elliptical opening; DETAILED DESCRIPTION
[0072] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.
[0073] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.
[0074] In the present invention, the term "longitudinal" refers to the direction from the distal end to the proximal end of the thrombectomy frame 100 in a naturally expanded state without external force; "longitudinal projection" refers to the projection from the distal end to the proximal end of the thrombectomy frame 100 in a naturally expanded state without external force (or a projection parallel to the longitudinal direction); "transverse" refers to the direction perpendicular to the longitudinal direction; and "circumferential" refers to the direction around the side surface between the two ends of the thrombectomy frame 100 in a naturally expanded state without external force.
[0075] Example 1
[0076] The embodiment of the present invention provides a vascular thrombus removal frame, which is designed as follows: Figures 2 to 7As shown, the thrombectomy frame 100 includes a distal end and a proximal end. The thrombectomy frame 100 is a mesh or cage-like structure with ribs 2. A plurality of spaced-apart narrowing portions 1 are provided between the distal end and the proximal end of the thrombectomy frame 100. The narrowing portions 1 are formed by the lateral narrowing of the thrombectomy frame 100. The narrowing portions 1 divide the outer contour of the thrombectomy frame 100, which has the function of stripping or capturing thrombi, into multiple sections. The ribs 2 forming the narrowing portions 1 include a plurality of rib pairs tending to intersect. The narrow slit structure or angle structure formed by the rib pairs can capture thrombus clots that tend to move away from the functional outer contour of the frame. It is understood that after the thrombus removal frame 100 is released in the blood vessel cavity (i.e., it changes from a contracted configuration to an expanded configuration), the functional outer contour frame can adhere to the blood vessel wall, squeezing / cutting / stripping the thrombus, causing it to enter the thrombus removal frame 100 and be captured; the narrowed portion 1, shaped like a basket or a pocket, can "pick up" the thrombus that has been stripped from the blood vessel wall by the functional outer contour frame of the proximal end of the thrombus removal frame 100, further preventing the escape of the thrombus; the narrowed portion 1 has a plurality of rib pairs (rib pairs are two or two sections of ribs 2) that tend to intersect, which can laterally intercept thrombus blocks that escape from the functional outer contour frame of the proximal end of the thrombus removal frame 100. Figure 1 As shown, in animal thrombectomy experiments, more thrombus clots accumulated within the lumen of the proximal functional outer contour of the thrombectomy frame 100 near the proximal end of the narrowed portion 1 than in other locations of the thrombectomy frame 100. This is because, on the one hand, the same thrombus clot excised or captured by the proximal functional outer contour of the thrombectomy frame 100 has a high probability of being intercepted, caught, or supported by multiple rib pairs at different locations simultaneously, preventing the thrombus clot from being torn and further fragmented during transport out of the body. On the other hand, thrombus clots that were excised or captured later, blocked by the previously captured thrombus clots on the thrombectomy frame 100, accumulated within the lumen of the distal first mesh section near the proximal end of the narrowed portion 1, effectively preventing small thrombus clots from escaping the lumen of the thrombectomy frame 100. Furthermore, the locally narrowed thrombectomy frame 100 reduces metal coverage, thereby minimizing damage to blood vessels. In these specific application embodiments, Figures 8-11As shown, the narrowed portion 1 is provided with a first rib pair 21 and a second rib pair 22 whose longitudinal projections do not overlap. The narrowed portion 1 is also provided with a second rib pair 22 and a third rib pair 26 whose longitudinal projections do not overlap. These rib pairs, whose longitudinal projections do not overlap / do not completely overlap, are staggered in the longitudinal space, improving the efficiency of intercepting free-state thrombus clots. Furthermore, these staggered rib pairs enable multiple capture locations on the same thrombus clot. It can also be understood that these first rib pairs 21 and second rib pairs 22 are rib pairs with a tendency to intersect (this tendency does not necessarily mean that the rib pairs intersect; it is also possible that the rib pairs are partially parallel). Each of these rib pairs contains a "corner unit 23" with a relatively narrow area formed by two ribs 2 approaching each other. These corner units 23 enable the interception / capturing of free-state thrombus clots in the lateral space of the thrombectomy frame 100. These corner units 23 are further spatially deployed, such as: deploying corner units 23 at different radii around the narrowed portion 1 to enhance the lateral interception capability of the narrowed portion 1; deploying two corner units 23 in a longitudinally staggered manner to enhance the lateral interception capability of the narrowed portion 1; having different relative openings between the corner units 23 (for example, if these corner units 23 are regarded as angles with an intersection, the two sides of the angle are the corresponding two ribs 2, and the angle formed by one rib 2 starting from the other rib 2 and rotating counterclockwise or clockwise is called the "relative opening"), so as to enhance the clamping / limiting capability of the narrowed portion 1 on the free thrombus clot.
[0077] The aforementioned "corner unit 23" also has another configuration: each of these rib pairs has two ribs 2 that are close to each other, and a connecting bridge member is provided between the two ribs 2 at one end of the ribs 2 to connect and define the two ribs 2. In this configuration of the "corner unit 23," the two ribs 2 that are close to each other and the connecting bridge member together form a relatively narrow area, which can significantly increase the probability of intercepting / entrapping free-state thrombus clots in the lateral space of the thrombectomy frame 100. Furthermore, if Figure 12As shown, a pair of corner units 23 with a common connecting bridge member are set to have different relative openings; this microstructure design for intercepting free thrombus clots is different from the existing distal embolic protection umbrella that uses a dense mesh structure to intercept and hold thrombus clots; this microstructure allows two local clots of the same free thrombus clot to pass through the curved surface where the two corner units 23 are located to the other side of the thrombectomy frame 100. Since the two corner units 23 have different relative openings, the local clots of the free thrombus clots after passing through the corner units 23 have different openings. Due to the different relative sliding restrictions (being pulled out of the lumen of the thrombectomy frame 100 or pulled back into the lumen), a localized clot in the corner element 23 with the weaker relative sliding restriction has a relatively easy sliding ability, thereby more effectively securing the other localized clot. In other words, the purpose of the two corner elements 23 having different relative openings is to allow the clot to enter the frame while also securing it. If both corner elements 23 slide easily, the clot will easily slip out and lose its grip. If neither of them slides easily, it will not easily enter the frame. During the process of removing a clot from the body, the localized clot in the corner element 23 with the stronger relative sliding restriction is further trapped in the narrow area (slit) of the corner element 23 due to the drag, and thus firmly secured by the corner element 23. This microstructure resembles an X or H. It is understandable that the microstructure with a common connecting bridge member is merely an implementation example to facilitate the explanation of the working principle of the microstructure; variants such as the following also have the functions of the aforementioned microstructure: an X structure formed by the intersection of two ribs 2; and a prismatic grid of varying sizes arranged on the narrowed portion 1.
[0078] In these specific application embodiments, the rib pairs that do not overlap / do not completely overlap in longitudinal projection also do not overlap / do not completely overlap in transverse projection. Arranging the rib pairs circumferentially staggered / staggered into groups and arranging these groups longitudinally on the thrombus retriever frame 100 can improve the efficiency of the thrombus capture frame 100 without requiring additional interception components (such as barbs or a dense mesh) as in the prior art.
[0079] In these specific application embodiments, except for the narrowed portion 1 , the thrombus removal frame 100 has an outer contour that gradually expands in the longitudinal direction.
[0080] In these specific application embodiments, Figure 2 As shown, the thrombus removal frame 100 has different narrowing portions 1. When a limited number of narrowing portions 1 are designed and arranged from the proximal end to the distal end of the thrombus removal frame 100, these narrowing portions 1 can enhance the interception function of the thrombus removal frame 100 through different variations; for example, the narrowing degree relative to the working outer contour is limited (such as Figure 15 and Figure 18As shown, the narrowing portion 1 also includes a first narrowing portion 110 and a second narrowing portion 120, and changes in the narrowing shape (for example, the side of the thrombus removal frame 100 is uniformly narrowed in an annular direction, the side of the thrombus removal frame 100 is spirally narrowed, as shown in FIG. Figure 13 The thrombectomy frame 100 shown has various variations of the narrowed portion 1, including a unidirectional narrowing of the side surface, different spatial arrangements of the node units on the narrowed portion 1, the presence or absence of barbs on the narrowed portion 1, and different barb shapes on the narrowed portion 1. Research has found that the unidirectional narrowing of the side surface of the thrombectomy frame 100 is particularly suitable for treating acute thrombi with atherosclerotic plaques. When the narrowing degree of the first narrowed portion 110 is greater than that of the second narrowed portion 120, it is particularly suitable for treating newly formed thrombi. When the narrowing degree of the first narrowed portion 110 is less than that of the second narrowed portion 120, it is particularly suitable for treating old thrombi. In this scenario, the functional outer contour of the frame between the two narrowed portions is preferably designed to have a planing function (one way to achieve this planing function is to deform a portion of the ribs 2 to form a planing blade, not shown in the figure). The narrowing degree mentioned here should be understood as the relative distance between the inner contour of the narrowed portion and the central axis of the thrombectomy frame 100.
[0081] In these specific application embodiments, the first narrowed portion 110 and the second narrowed portion 120 divide the outer frame of the thrombus removal frame 100 that has the function of removing or capturing thrombi into a first functional frame 610 , a second functional frame 620 and a third functional frame 630 . In some scenarios, the first functional frame 610, the second functional frame 620, and the third functional frame 630 cooperate to capture thrombus. The first functional frame 610 is designed to have the function of introducing thrombus fragments (the introduction port can be the proximal elliptical opening 9 or the opening surrounded by the ribs 2 on the side of the frame, not shown in the figure) into the lumen of the thrombus removal frame 100, while also having a primary shaving function. The second functional frame 620 is designed to have an intermediate shaving function that is a step further than the primary shaving function. The distal end of the third functional frame 630 is provided with an elastic membrane (not shown in the figure), which can be expanded like an umbrella by the ribs 2 to capture small thrombus fragments. The third functional frame 630 can also be further designed to have an advanced shaving function. The primary, intermediate, and advanced shaving functions mentioned here should be understood as gradually shaving the thrombus in the vascular lumen layer by layer from the center of the blood vessel radially outward. The planing component of the thrombus removal frame 100 can be formed by the ribs 2 on the functional outer contour frame. This arrangement can be to twist and deform some ribs 2 relative to other ribs 2 to form planing blade components, or to set planing blade components relative to the ribs 2.
[0082] In these specific application embodiments, Figures 15 to 21As shown, the proximal end of the first functional frame 610 is designed to have an introduction structure 8 that is relatively easy to introduce into the catheter assembly. The introduction structure 8 can reduce the radial support force of the proximal section of the first functional frame 610, so that the proximal section of the first functional frame 610 can be relatively easy to radially shrink to a suitable size and enter the catheter assembly cavity through the catheter assembly orifice. The introduction structure 8 includes a corrugated member arranged at an angle to the longitudinal direction; the number of corrugated members can be set to multiple. The introduction structure 8 includes a plurality of corrugated members arranged along the circumferential direction, and at least some of the corrugated members are connected end to end with other corrugated members (such as Figure 20 As shown, the first corrugated member 810, the second corrugated member 820, and the third corrugated member 830). Figure 22 As shown, the lead-in structure 8 is positioned in the sidewall region of the first functional frame 610 near the elliptical opening 9 at the proximal end. Furthermore, the lead-in structure 8 is positioned in the sidewall region near the distal end 920 of the elliptical opening. The lead-in structure 8 comprises a plurality of corrugated mesh units 840. These units are formed by ribs 2 and corrugated members forming a mesh boundary. The corrugated members form either the proximal or distal end of the corrugated mesh units 840, and the ribs 2 are straight. The corrugated mesh units 840 have continuous boundaries.
[0083] In these specific application embodiments, the elastic membrane may be replaced by some inelastic film materials (non-elastic membrane).
[0084] In these specific application embodiments, the elastic membrane may also be replaced by some dense mesh structures.
[0085] In these specific application embodiments, the dense mesh structure may be umbrella-shaped.
[0086] The aforementioned elastic films and non-elastic films can be commercially available, such as PU films from GERGONNE, SEPTON films from Kuraray, and various series of SEPTON films. TM Products, silicone membrane, ethylene-tetrafluoroethylene copolymer ETFE, etc.
[0087] The aforementioned dense mesh structures may be made of fiber fabric or metal wire fabric.
[0088] The aforementioned elastic membrane, inelastic membrane, and dense mesh structure are collectively referred to as a structure for preventing thrombus distal drift. The structure for preventing thrombus distal drift is also employed in the following embodiments. Sometimes, the structure for preventing thrombus distal drift can be a combination of an elastic membrane, an inelastic membrane, and a dense mesh structure.
[0089] In these specific application embodiments, Figure 14As shown, these intersecting rib pairs each have a relatively narrow hooking region 24, which is the region bounded by the intersection angle of the two ribs 2 or the intersection angle of the extension lines of the two ribs 2. In these specific applications, the ribs 2 or corners of the hooking region 24 are partially / completely increased in contact area with the thrombus clot, thereby preventing the thrombus clot from deeply embedding into the region / rib 2, while also giving the hooking region 24 the ability to longitudinally support the thrombus clot.
[0090] Example 2
[0091] In an embodiment of the present invention, a vascular thrombus removal frame is designed as follows: it includes a thrombus removal frame 100 having a distal end and a proximal end, the thrombus removal frame 100 being a mesh tube or cage-like structure having ribs 2; a narrowing portion 1 formed by the thrombus removal frame 100 being narrowed laterally is provided between the distal end and the proximal end of the thrombus removal frame 100; the narrowing portion 1 divides the thrombus removal frame 100 into a first mesh portion and a second mesh portion for stripping or capturing thrombi; the first mesh portion and the second mesh portion of the thrombus removal frame 100 both have an outer contour that gradually increases in size from the proximal end to the distal end; Figure 16 As shown, the narrowed portion 1 is provided with a plurality of node units 25 connecting the two ribs 2; the plurality of node units 25 form a three-dimensional array capable of laterally intercepting free thrombi. It can be understood that: after the thrombus removal frame 100 is released in the blood vessel cavity (i.e., it changes from a contracted configuration to an expanded configuration), the first mesh portion and the second mesh portion can adhere to the blood vessel wall, squeeze / cut / peel off the thrombus, and make it enter the thrombus removal frame 100 and be captured; the first mesh portion and the second mesh portion have gradually enlarged functional outer contours, which can gradually adhere to the blood vessel wall and remove potential residual thrombi; the narrowed portion 1 shaped like a basket or a pocket can "pouch" the thrombus that has been peeled off the blood vessel wall by the first mesh portion, further preventing the escape of the thrombus; the plurality of node units 25 in the three-dimensional array on the narrowed portion 1 can laterally intercept the thrombus that escapes from the distal end of the first mesh portion. As shown Figure 1As shown, in animal thrombus removal experiments, more thrombus clots accumulated in the lumen of the distal section of the first mesh portion of the thrombectomy frame 100 near the proximal end of the narrowed portion 1 than in other parts of the thrombectomy frame 100. This is because, on the one hand, the same thrombus clot exfoliated or captured by the first mesh portion has a high probability of being simultaneously intercepted, restricted, or supported by the multiple node units 25 of the three-dimensional array at different locations, preventing the thrombus clot from being torn and further fragmented during transport out of the body. On the other hand, thrombus clots that were exfoliated or captured later were blocked by the thrombus clots previously captured by the thrombectomy frame 100 and accumulated in the lumen of the distal section of the first mesh portion near the proximal end of the narrowed portion 1, effectively preventing small thrombus clots from escaping the lumen of the thrombectomy frame 100. Furthermore, the locally narrowed thrombectomy frame 100 reduces metal coverage, thereby minimizing damage to blood vessels. The first grid portion mentioned here can also be understood as equivalent to the aforementioned first functional frame 610, and the second grid portion can also be understood as equivalent to the aforementioned second functional frame 620.
[0092] The node units 25 have two configurations: one is a node unit 25 with a connecting bridge member, and the other is a node unit 25 without a connecting bridge member (such as the intersection of two ribs 2). The narrowing portion 1 with a connecting bridge member can be further designed so that the connecting bridge lengths between the node units 25 are different.
[0093] In some specific application embodiments, such as Figures 26-29 As shown, the node unit 25 on the narrowed portion is closest to the axis of the stent.
[0094] In some specific application embodiments, such as Figures 30-33 As shown, different from the previous embodiment, the node unit 25 on the narrowed portion is not the structure closest to the axis of the bracket, but the ribs between two adjacent node units 25 are closest to the axis of the bracket.
[0095] In some specific application embodiments, such as Figures 34-37 As shown, the first functional frame and the second functional frame have the same diameter.
[0096] In some specific application embodiments, such as Figure 38 As shown, the first functional frame, the second functional frame and the third functional frame all have the same diameter.
[0097] In some specific application embodiments, such as Figure 39 As shown, the sizes of the diamond grids formed by adjacent ribs are equal.
[0098] In some specific application embodiments, such as Figure 40 As shown, the size of the diamond grid formed by adjacent ribs changes gradually.
[0099] In these specific application embodiments, Figures 15-17 As shown, the node unit 25 includes a first node 251, a second node 252, and a third node 253. The first node 251 is not located on the straight line formed by the second node 252 and the third node 253, and the first, second, and third nodes 251, 252, 253 are not located in the same plane. In other words, the projections of the first, second, and third nodes 251, 252, 253 in the longitudinal direction of the thrombectomy frame 100 do not overlap. These node units 25 whose longitudinal projections do not overlap / do not completely overlap also do not overlap / do not completely overlap in the transverse direction. Arranging several node units 25 in a circumferentially staggered / staggered manner into groups and arranging these groups in a longitudinal array on the thrombectomy frame 100 can improve the efficiency of the thrombectomy frame 100 in capturing thrombi without requiring the addition of additional interception members (such as barbs or a dense mesh) as in the prior art.
[0100] The narrowed portion 1 shaped like a basket or a pocket can "pick up" the thrombus that has been peeled off the blood vessel wall by the first mesh portion, further preventing the escape of the thrombus; this "pick up" effect is different from the existing technology that uses barbs to puncture and anchor thrombus blockages, and is also different from the existing technology that uses a film / membrane to cooperate with a frame and use the film / membrane to form a pocket / net bag to collect / hold the thrombus. For example, in the prior art, after the same piece of thrombus is anchored by multiple barbs, during the process of removal / transportation outside the blood vessel, the stent body inevitably passes through various tortuous bends / narrow cavities, resulting in deformation / adaptive deformation of the stent body; at this time, the multiple barbs inevitably undergo relative displacement / deformation, thereby tearing / cutting and fragmenting the thrombus; in addition, the thrombus in the stent body cavity is also likely to be subjected to a force toward the distal end of the stent body, causing it to slip relative to the stent body, further aggravating the tearing effect; arranging a thin film / coating at the distal end of the stent body to hold the free thrombus block can solve the above-mentioned problem to a certain extent, but this will inevitably complicate the entire thrombus remover structural design, increase manufacturing costs and medical costs, and will also introduce more uncertain risks during the operation (such as whether the coating is firmly bonded to the stent body, whether the coating falls off during the operation, etc.). Research has found that it is beneficial to arrange a limited number of node units 25 with a lateral blocking area (preferably a lateral blocking area that can effectively prevent the ribs 2 near the nodes from being partially embedded in the thrombus clot) in the cavity space relative to the working outer contour of the thrombus removal frame 100 (stent body) (i.e., the grid working surface for stripping or capturing thrombi); the introduction of such node units 25 can effectively solve the shortcomings of barb anchoring, and at the same time can play the role of a net bag without the need for a coating; in addition, because such node units 25 are a three-dimensional array, they can also overcome the shortcomings of a two-dimensional planar array (such as insufficient interception efficiency and high array density).
[0101] In these specific application embodiments, the second mesh portion can further peel off or capture residual thrombus relative to the first mesh portion. It can be understood that: in these specific applications, by adjusting / regulating the functional outer contour size of the first mesh portion and the second mesh portion (for example, setting different diameter values for each section of the thrombus removal frame 100) or the size of the local mesh aperture, the corresponding functions of different sections of the thrombus removal frame 100 are enhanced; wherein, it is desirable to enable the second mesh portion to further peel off or capture residual thrombus relative to the first mesh portion. Studies have found that the mesh aperture of the first mesh portion or the second mesh portion is larger than that of the narrowed portion 1 (for example, Figure 18 As shown, the mesh apertures of the first mesh 710 and the third mesh 730 are both larger than the mesh aperture of the second mesh 720, and the mesh apertures of the first mesh 710 and the third mesh 730 are both larger than the mesh aperture of the fourth mesh 740); the mesh aperture of the first mesh portion or the second mesh portion is larger than the narrowed portion 1, and the mesh aperture of the second mesh portion is the largest; the mesh aperture of the first mesh portion or the second mesh portion is larger than the narrowed portion 1, and the mesh aperture of the first mesh portion is smaller than the mesh aperture of the second mesh portion; the aforementioned three mesh aperture size deployment designs are all beneficial to the thrombus removal frame 100 in cutting / capturing / intercepting / preventing escape of thrombi, while also reducing metal coverage and reducing vascular damage.
[0102] In these specific application embodiments, the vascular thrombus retriever stent is provided with a first narrowed portion 110 and a second narrowed portion 120; the second mesh portion is disposed between the first narrowed portion 110 and the second narrowed portion 120. In these specific applications, by designing and arranging a limited number (e.g., 2 or more but less than 20) of narrowed portions 1 (these narrowed portions 1 can have the same or different structures) on the thrombus retriever stent 100 from the proximal end to the distal end, the thrombus retriever stent 100 is provided with lateral interception capabilities or graded interception capabilities in different sections. It is desirable that the thrombus retriever stent 100 is provided with the first narrowed portion 110 and the second narrowed portion 120, and the second mesh portion is disposed between the first narrowed portion 110 and the second narrowed portion 120. When a limited number of constrictions 1 are designed and arranged on the thrombectomy frame 100 from the proximal end to the distal end, these constrictions 1 can be modified to enhance the interception function of the thrombectomy frame 100. For example, the degree of constriction relative to the working outer contour, the variation of the constriction shape (e.g., uniform circumferential constriction of the thrombectomy frame 100 side, spiral constriction of the thrombectomy frame 100 side, unidirectional constriction of the thrombectomy frame 100 side), the different spatial arrangements of the node units on the constriction 1, the presence or absence of barbs on the constriction 1, the different barb shapes on the constriction 1, and other variations of the constriction 1. Research has found that the unidirectional constriction of the thrombectomy frame 100 side is particularly suitable for acute thrombosis with atherosclerotic plaques.
[0103] In these specific application embodiments, the vascular thrombectomy stent can be a laser-cut stent or a braided stent. When the vascular thrombectomy stent is a braided stent, the two ribs 2 of the braided stent have intersecting node units 25. These node units are reinforced to effectively prevent the ribs 2 near the node from being partially embedded in thrombi. The effect of these node units on blocking, intercepting, and retaining thrombi can be enhanced by wrapping a thread around the intersection of the two ribs 2 of the braided stent to increase the lateral contact area at the intersection.
[0104] In these specific application embodiments, the outer contour of the distal end of the vascular thrombectomy stent can be an open trumpet structure; that is, the outer contour of the proximal end of the vascular thrombectomy stent is smaller than the outer contour of the distal end.
[0105] Example 3
[0106] In an embodiment of the present invention, a vascular thrombectomy stent is designed to include a thrombectomy stent 100 having a distal end and a proximal end. The thrombectomy stent 100 is a tubular or cage-like structure with ribs 2. A narrowed portion 1 formed by a transverse narrowing of the thrombectomy stent 100 is disposed between the distal and proximal ends. The narrowed portion 1 divides the thrombectomy stent 100 into a first mesh portion for stripping or capturing thrombi and a second mesh portion, with the second mesh portion further stripping or capturing residual thrombi relative to the first mesh portion. The thrombectomy stent 100 is provided with a plurality of first node units 25 connecting the two ribs 2. The narrowed portion 1 includes a plurality of second node units 25, which are different from the first node units 25 of the thrombectomy stent 100. The plurality of second node units 25 form a three-dimensional array capable of laterally intercepting free thrombi. It is understood that enabling the second mesh portion to further strip or capture residual thrombi relative to the first mesh portion is desirable, thereby enabling complete removal of thrombi from the vessel wall. Research has found that by adjusting / regulating the functional outer contour sizes of the first and second mesh portions (for example, setting different diameter values for different sections of the thrombus retriever 100) or the size of the local mesh apertures, the corresponding functions of different sections of the thrombus retriever 100 can be enhanced, which is beneficial for the thrombus retriever 100 to cut / capture / intercept / prevent escape of thrombi, while also reducing metal coverage and alleviating vascular damage.
[0107] In these specific application embodiments, the first grid portion and the second grid portion of the thrombus removal frame 100 both have outer contours that gradually increase in size from the proximal end to the distal end.
[0108] In these specific application embodiments, the vascular thrombectomy frame is provided with a first narrowed portion 110 and a second narrowed portion 120 ; the second mesh portion is provided between the first narrowed portion 110 and the second narrowed portion 120 .
[0109] like Figure 10As shown, in these specific application embodiments, a grid unit of wave-shaped ribs 2 is arranged at the proximal end of the thrombus removal frame 100 .
[0110] In some specific application embodiments, such as Figures 23 and 24 As shown, the vascular thrombectomy frame further includes a V-shaped hanging component.
[0111] In these specific application embodiments, Figure 18 As shown, the distal end of the thrombectomy frame 100 is provided with a plurality of bundled portions 631. The bundled portions 631 are concentrated toward the central axis of the thrombectomy frame 100 and bound together, so that the distal end of the thrombectomy frame 100 is in a closed state. The member used to bind the bundled portions 631 can be a metal wire, a fiber string, or a cylindrical member.
[0112] In some specific application embodiments, such as Figure 25 As shown, the proximal end of the thrombectomy frame has multiple tendons, which are connected to the manipulation component through the bundle of tendons.
[0113] The present invention also provides a vascular thrombus removal device, as follows:
[0114] The present invention provides a vascular thrombus removal device, such as Figures 41 to 45 As shown, the thrombus removal frame 100 includes a distal end and a proximal end, and an elongated manipulation member 300 connected to the proximal end of the thrombus removal frame 100. The proximal end of the thrombus removal frame 100 is connected to the manipulation member 300 via a connecting rib 5, at least part of which is wavy and / or spiral.
[0115] The present invention provides a buffering function by configuring the connecting ribs 5 to be wavy and / or spiral, thereby releasing internal stress during the pushing process to play a buffering role, thereby enhancing the stability of the stent during pushing and retrieving, improving the operator's operating feel, and reducing the damage to the blood vessels caused by the thrombectomy frame 100.
[0116] Preferably, Figure 42 As shown, in the embodiment of the present invention, part of the connecting ribs 5 are preferably configured to be wavy. The wavy connecting ribs 5 are easy to manufacture, and their buffering performance is sufficient to meet the needs of surgery.
[0117] In some embodiments, the thrombectomy frame 100 is a mesh-like or cage-like structure with ribs; a restrictive unit for intercepting free thrombus is provided between the distal and proximal ends of the thrombectomy frame 100; the restrictive unit includes a narrowed portion 1 formed by the longitudinal narrowing of the thrombectomy frame 100 and a plurality of intercepting members provided on the narrowed portion 1.
[0118] It is understood that after the thrombus removal frame 100 is released in the blood vessel cavity (i.e., it changes from a contracted configuration to an expanded configuration), the functional outer contour frame can adhere to the blood vessel wall, squeezing / cutting / stripping the thrombus, causing it to enter the thrombus removal frame 100 and be captured; the narrowed portion 1, shaped like a basket or a pocket, can "pick up" the thrombus that has been stripped from the blood vessel wall by the functional outer contour frame of the proximal end of the thrombus removal frame 100, further preventing the escape of the thrombus; the narrowed portion 1 has an interception member (i.e., a plurality of intersecting rib pairs, a rib pair being two or two sections of ribs), which can laterally intercept the thrombus that escapes from the functional outer contour frame of the proximal end of the thrombus removal frame 100. Figure 1 As shown, in animal thrombectomy experiments, more thrombus clots accumulated within the lumen of the proximal functional outer profile of the thrombectomy frame 100, near the proximal surface of the narrowed portion 1, than within other locations of the thrombectomy frame 100. This is because, on the one hand, the same thrombus clot exfoliated or captured by the proximal functional outer profile of the thrombectomy frame 100 has a high probability of being intercepted, caught, or supported by multiple rib pairs at different locations simultaneously, preventing the thrombus clot from being torn and further fragmented during transport out of the body. On the other hand, thrombus clots exfoliated or captured later, blocked by previously captured thrombus clots on the thrombectomy frame 100, accumulated within the lumen of the distal section of the mesh portion 27, near the proximal surface of the narrowed portion 1, effectively preventing small thrombus clots from escaping the lumen of the thrombectomy frame 100. Furthermore, the locally narrowed thrombectomy frame 100 reduces metal coverage, thereby minimizing vascular damage.
[0119] In some embodiments, the intercepting member includes two ribs forming the thrombus removal frame 100 and a connecting element connecting the two ribs, wherein the connection between the connecting element and the two ribs forms a node unit.
[0120] Optionally, the intercepting members have different connecting element lengths to form node units of different lengths.
[0121] The narrowed portion 1 shaped like a basket or a pocket can "pick up" the thrombus that has been peeled off the blood vessel wall by the mesh portion 27, further preventing the escape of the thrombus; this "pick up" effect is different from the existing technology that uses barbs to puncture and anchor thrombus blockages, and is also different from the existing technology that uses a film / membrane to cooperate with a frame and use the film / membrane to form a pocket / net bag to collect / hold the thrombus. For example, in the prior art, after the same piece of thrombus is anchored by multiple barbs, during the process of removal / transportation outside the blood vessel, the stent body inevitably passes through various tortuous bends / narrow cavities, resulting in deformation / adaptive deformation of the stent body; at this time, the multiple barbs inevitably undergo relative displacement / deformation, thereby tearing / cutting and fragmenting the thrombus; in addition, the thrombus in the stent body cavity is also likely to be subjected to a force toward the distal end of the stent body, causing it to slip relative to the stent body, further aggravating the tearing effect; arranging a thin film / coating at the distal end of the stent body to hold the free thrombus block can solve the above-mentioned problem to a certain extent, but this will inevitably complicate the entire thrombus remover structural design, increase manufacturing costs and medical costs, and will also introduce more uncertain risks during the operation (such as whether the coating is firmly bonded to the stent body, whether the coating falls off during the operation, etc.). Research has found that it is beneficial to arrange a limited number of node units with a lateral blocking area (preferably a lateral blocking area that can effectively prevent the ribs near the node from being partially embedded in the thrombus clot) in the cavity space relative to the working outer contour of the thrombectomy frame 100 (stent body) (i.e., the grid working surface for stripping or capturing thrombi); the introduction of such node units can effectively solve the shortcomings of barb anchoring, and at the same time can play the role of a net bag without the need for a coating; in addition, because such node units are a three-dimensional array, they can also overcome the shortcomings of a two-dimensional planar array (such as insufficient interception efficiency and high array density).
[0122] In some embodiments, the two ribs of the intercepting member and the connecting element form a first limiting angle that can limit the movement of the free thrombus toward the distal end of the thrombus removal frame 100 .
[0123] The first limiting angle can clamp the free thrombus moving toward the distal end of the thrombus removal frame 100 to prevent it from detaching from the thrombus removal frame 100 .
[0124] In some embodiments, the narrowed portion 1 divides the thrombus removal frame 100 into multiple mesh portions 27 for stripping or capturing thrombi. The multiple mesh portions 27 each have an outer profile that gradually increases in size from the proximal end to the distal end. This embodiment can further enhance the effect of preventing thrombus detachment.
[0125] In some embodiments, the connecting rib 5 and the control member 300 are connected by a hypotube 200 .
[0126] Specifically, such as Figures 44 and 45As shown, a schematic diagram of the connection of the sea wave tube 200 is shown. The proximal end of the connecting rib 5 is connected to the control component 300 through the sea wave tube 200. A developing element 400 is provided on the outside of the connecting rib 5. Both sides of the surface of the sea wave tube 200 are provided with staggered slots 32 to enhance the elasticity and bending performance of the sea wave tube 200.
[0127] A filling hole 31 is opened on the surface of the sea wave tube 200; the filling hole 31 covers the connection between the connecting rib 5 and the operating component 300; after the filling hole 31 is filled with the filler, a force is generated to prevent the operating component 300 and the connecting rib 5 from relative displacement; the filler is fixed in the filling hole 31 by welding, gluing or riveting; the filler at least covers the end surface where the connecting rib 5 and the operating component 300 are connected.
[0128] The interface of the filling hole 31 can be a regular circle, a square, or an irregular ellipse, etc.; the filling hole 31 is filled with a filler, and the filler is fixed in the filling hole 31 by welding, gluing, or riveting. After filling, a force is generated to prevent the cutting thrombectomy frame 100 and the manipulation member 300 from relative displacement, thereby achieving a stable connection between the thrombectomy frame 100 and the manipulation member 300.
[0129] In some embodiments, the projections of any two connecting elements on the same narrowed portion on the distal end surface of the thrombus remover frame do not overlap.
[0130] These circumferentially staggered connecting elements improve the efficiency of intercepting free thrombus clots. In addition, these staggered connecting element pairs make it possible to clamp the same thrombus clot at multiple locations. This can be understood as follows: the connecting element and the two ribs connected thereto can form a first limiting angle, which can limit the movement of free thrombi toward the distal end of the thrombectomy frame 100.
[0131] Note: The thrombectomy stent 100 in the vascular thrombectomy device provided in the embodiments of the present invention can utilize the vascular thrombectomy stents provided in the aforementioned embodiments of the present invention, with adaptive improvements made to the connecting ribs 5, such that at least a portion of the connecting ribs 5 are configured in a wavy and / or spiral shape. In other words, the features of the vascular thrombectomy stents provided in the aforementioned embodiments can all be applied to the vascular thrombectomy device provided in the embodiments of the present invention.
[0132] The present invention also provides a thrombus removal system, such as Figures 46 and 47As shown, the thrombectomy frame 100, an elongated manipulation member connected to the proximal end of the thrombectomy frame 100, and a suction catheter 500 for connecting to a negative pressure source, the distal end of the suction catheter 500 is made of a deformable material, and the distal end of the suction catheter 500 has a normal state and an expanded state; in the normal state, the cross section at a distance a from the distal end of the suction catheter 500 is a first cross section, and in the expanded state, the cross section at a distance a from the distal end of the suction catheter 500 is a second cross section, where a is not a constant value, that is, the first cross section and the second cross section are At the same axial position of the aspiration catheter 500, the first cross-section is smaller than the second cross-section, and the second cross-section can completely cover the first cross-section (assuming that the first cross-section and the second cross-section are taken out as a plane and overlapped, the edge of the first cross-section does not protrude from the second cross-section); the thrombectomy frame 100 has a contracted configuration capable of passing through the lumen of the aspiration catheter 500 and an expanded configuration capable of expanding the distal section of the aspiration catheter 500. The control component controls the passage of the thrombectomy frame 100 within the aspiration catheter 500 and switches the configuration of the thrombectomy frame 100.
[0133] The distal end section of the aspiration catheter 500 in the embodiment of the present invention is made of a deformable material. During the aspiration preparation stage, the aspiration catheter 500 in a normal state with a small cross-section can be passed through the blood vessel. Before approaching the thrombus and aspirating, the thrombus removal frame 100 can be used to expand the distal end section of the aspiration catheter 500 so that the distal end section of the aspiration catheter 500 is in an expanded state with a large cross-section, thereby achieving aspiration of large thrombi and improving the thrombus aspiration efficiency.
[0134] This embodiment does not limit the specific structure and material of the suction catheter 500 , which means that as long as the distal end section is made of a deformable material so that the distal end section of the suction catheter 500 has a normal state and an expanded state, it will be sufficient.
[0135] Specifically, the material of the distal section of the suction catheter 500 can be a material with a rebound function, or a material without a rebound function. The distal section of the suction catheter 500 and other parts can be made of the same material, or different materials can be used. The tube body of the distal section of the suction catheter 500 includes, from the inside to the outside, a polymer layer, a memory metal skeleton, and a polymer layer; the polymer layer is preferably a hydrophilic and lubricating polymer (such as polyvinyl pyrrolidone (PVP), polyacrylamide (PAM), polyethylene glycol (PEG), polyvinyl alcohol (PVA), natural polysaccharides and derivatives, etc.; linear elastic polyacrylamide hydrogel and polydimethylsiloxane (PDMS) elastomer coated with ECM protein can also be selected; or silicone rubber, polyurethane and its block copolymers, polytetrafluoroethylene, polyethylene, polypropylene, polyvinyl chloride, polymethyl methacrylate, polyurethane, polyethylene terephthalate, nylon, ABS and polycarbonate, etc.), and the memory metal skeleton is preferably a nickel-titanium memory alloy material.
[0136] In some embodiments, the thrombus removal frame 100 is a mesh-like or cage-like structure composed of multiple ribs; a narrowed portion 1 formed by radially narrowing the thrombus removal frame 100 is provided between the distal end and the proximal end of the thrombus removal frame 100 .
[0137] The thrombus removal system provided in this embodiment includes a thrombus removal frame 100 having a narrow portion 1 for accommodating and clamping a thrombus, thereby improving the efficiency and effect of thrombus removal.
[0138] With respect to the thrombus removal frame 100, the above embodiment also only limits the thrombus removal frame 100 to having a narrowed portion 1 and having a contracted configuration and an expanded configuration, that is, as long as the thrombus removal frame 100 has a narrowed portion 1 and has a contracted configuration and an expanded configuration, it can be used in the above embodiment. Specifically, the manipulation component includes a delivery rod and a sheath. The manipulation component is used to manipulate the thrombus removal frame 100 to pass through the lumen of the suction catheter 500. The delivery rod is connected to the proximal end of the thrombus removal frame 100. The delivery rod is used to manipulate the thrombus removal frame 100 to move in the sheath. When the thrombus removal frame 100 is located in the sheath, it is in a contracted configuration. When the delivery rod manipulates the thrombus removal frame 100 to move out of the sheath, the thrombus removal frame 100 is released to be in an expanded configuration. This belongs to the means in the prior art and will not be described in detail here.
[0139] Based on the above embodiments, in order to facilitate changing the radial value of the narrowed portion 1 of the thrombus retriever 100 within the blood vessel, in some embodiments, the narrowed portion 1 can controllably change its narrowing degree relative to the thrombus retriever 100 .
[0140] Specifically, the ribs of the constricted portion 1 are a memory alloy having austenite and martensite, and the constriction process is electrically induced, that is, the degree of constriction can be changed by passing currents of different magnitudes through the thrombectomy frame 100 in the body.
[0141] In this embodiment, a power supply assembly is required to connect to the proximal end of the thrombus removal frame 100 , and the magnitude and on / off of the current in the thrombus removal frame 100 are controlled by the power supply assembly.
[0142] In some embodiments, the narrowed portion 1 divides the thrombus removal frame 100 into a plurality of mesh portions 27 for stripping or capturing thrombi; the plurality of mesh portions 27 have an outer contour that gradually increases from the proximal end to the distal end (in terms of the expanded configuration). This embodiment can further enhance the effect of preventing thrombus detachment. Specifically, when this embodiment is implemented, the thrombus removal frame 100 in the contracted configuration is driven by the control member to pass through the thrombus segment or thrombus portion in the blood vessel, and then the thrombus removal frame 100 is released to expand. After the release is completed, the thrombus is caught by withdrawing the thrombus holder 100 into the aspiration catheter 500. After the thrombus is close to the aspiration catheter 500, the thrombus is sucked into the aspiration catheter 500 with the help of negative pressure to achieve the removal of the thrombus. Of course, since the distal end of the aspiration catheter 500 has the ability to deform and the overall profile of the thrombus holder 100 gradually becomes larger, the distal end of the aspiration catheter 500 can be expanded during the process of withdrawing the thrombus holder 100 into the aspiration catheter 500, thereby facilitating the aspiration of large thrombi.
[0143] It should be noted that in some scenarios, the thrombus removal frame 100 can be retracted by manipulating the member, and then driven to move to the distal end of the aspiration catheter 500 and then released. At this time, large thrombi can be aspirated. The specific operation process should be carried out according to the specific judgment of the clinical physician.
[0144] In some embodiments, the narrowed portion 1 is provided with a plurality of node units 25 connecting the two ribs; the plurality of node units 25 form a three-dimensional array capable of longitudinally intercepting free thrombus.
[0145] The narrowed portion 1 shaped like a basket or a pocket can "pick up" the thrombus that has been peeled off the blood vessel wall by the mesh portion 27, further preventing the escape of the thrombus; this "pick up" effect is different from the existing technology that uses barbs to puncture and anchor thrombus blockages, and is also different from the existing technology that uses a film / membrane to cooperate with a frame and use the film / membrane to form a pocket / net bag to collect / hold the thrombus. For example, in the prior art, after the same piece of thrombus is anchored by multiple barbs, during the process of removal / transportation outside the blood vessel, the stent body inevitably passes through various tortuous bends / narrow cavities, resulting in deformation / adaptive deformation of the stent body; at this time, the multiple barbs inevitably undergo relative displacement / deformation, thereby tearing / cutting and fragmenting the thrombus; in addition, the thrombus in the stent body cavity is also likely to be subjected to a force toward the distal end of the stent body, causing it to slip relative to the stent body, further aggravating the tearing effect; arranging a thin film / coating at the distal end of the stent body to hold the free thrombus block can solve the above-mentioned problem to a certain extent, but this will inevitably complicate the entire thrombus remover structural design, increase manufacturing costs and medical costs, and will also introduce more uncertain risks during the operation (such as whether the coating is firmly bonded to the stent body, whether the coating falls off during the operation, etc.). Research has found that it is beneficial to arrange a limited number of node units 25 with a lateral blocking area (preferably a lateral blocking area that can effectively prevent the ribs near the node from being partially embedded in the thrombus clot) in the cavity space relative to the working outer contour of the thrombus removal frame 100 (stent body) (i.e., the grid working surface for stripping or capturing thrombi); the introduction of such node units 25 can effectively solve the shortcomings of barb anchoring, and at the same time can play the role of a net bag without the need for a coating; in addition, because such node units 25 are a three-dimensional array, they can also overcome the shortcomings of a two-dimensional planar array (such as insufficient interception efficiency and high array density).
[0146] In some embodiments, the distal end of the thrombus removal frame 100 has an open structure, which facilitates the entry of the thrombus into the interior for thrombus removal after the thrombus removal frame 100 is released.
[0147] In some embodiments, the proximal end of the thrombus removal frame 100 is connected to the delivery rod via connecting ribs, and the number of connecting ribs is 1 to 9, more preferably 1 to 4.
[0148] In a more preferred embodiment, at least one connecting rib has a wavy structure.
[0149] This embodiment provides a buffering function by configuring a portion of the structure in the connecting ribs to be wavy, thereby releasing internal stress during the pushing process to play a buffering role, thereby enhancing the stability of the stent during pushing and retrieving, improving the operator's operating feel, and reducing damage to the blood vessels caused by the thrombectomy frame 100.
[0150] Description: The thrombus removal system provided by the embodiment of the present invention comprises a thrombus removal frame and an elongated control member connected to the proximal end of the thrombus removal frame, which form a vascular thrombus removal device. The vascular thrombus removal device can adopt the vascular thrombus removal devices provided by the above-mentioned multiple embodiments of the present invention. That is, the features of the vascular thrombus removal devices provided by the above-mentioned multiple embodiments can all be applied to the thrombus removal system provided by the embodiment of the present invention.
[0151] The present invention uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only intended to help understand the method and core concept of the present invention. At the same time, those skilled in the art will find that the specific implementation methods and application scopes may vary based on the concept of the present invention. In summary, the contents of this specification should not be construed as limiting the present invention.
Claims
1. A vascular thrombus removal frame, comprising a thrombus removal frame having a distal end and a proximal end, wherein the thrombus removal frame is a mesh tube or cage structure having ribs; A plurality of spaced-apart constrictions are provided between the distal and proximal ends of the thrombectomy frame. The constrictions are formed by transverse constriction of the thrombectomy frame. The constrictions divide the outer contour of the thrombectomy frame, which functions to remove or capture thrombi, into multiple segments. The ribs forming the constrictions include a plurality of intersecting rib pairs. The narrow slits or angles formed by the rib pairs can capture thrombi that tend to move away from the functional outer contour of the frame. The rib pairs include an angle unit having a relatively narrow area formed by two ribs approaching each other, with the angle units having different relative openings. The thrombectomy frame also includes an inlet structure provided at the proximal end of the thrombectomy frame. The inlet structure is provided on the side wall of the frame near the elliptical opening and can reduce radial support forces at the proximal end of the thrombectomy frame. The inlet structure comprises a plurality of corrugated mesh units, each of which is formed by mesh boundaries formed by ribs and corrugated members. The corrugated members constitute the proximal or distal segments of the corrugated mesh units, and the ribs are linear ribs.
2. The thrombectomy stent according to claim 1, characterized in that: The narrowed portion divides the thrombus removal frame into a plurality of mesh portions for stripping or capturing thrombi; each of the plurality of mesh portions has an outer contour that gradually increases in size from the proximal end to the distal end.
3. The vascular thrombectomy stent according to claim 1, characterized in that: The narrowed portion is provided with a first pair of ribs and a second pair of ribs whose longitudinal projections do not overlap.
4. The thrombectomy stent according to claim 1, characterized in that: The thrombus removal frame has narrowed portions with different degrees of narrowing.
5. A vascular thrombectomy frame, comprising a thrombectomy frame having a distal end and a proximal end, characterized in that: The thrombectomy frame is a tubular or cage-like structure with ribs. A narrowing portion formed by transverse constriction of the thrombectomy frame is provided between the distal and proximal ends of the thrombectomy frame. The narrowing portion divides the thrombectomy frame into a plurality of mesh sections for removing or capturing thrombi. The plurality of mesh sections have an outer profile that gradually increases in size from the proximal end to the distal end. The ribs forming the narrowing portion include several pairs of connected ribs forming a plurality of node units. The plurality of node units form a three-dimensional array capable of laterally intercepting free thrombi. The node units have different connecting bridge lengths. The thrombectomy frame also includes an introduction structure provided at the proximal end of the thrombectomy frame. The proximal end of the thrombectomy frame is provided with an elliptical opening. The introduction structure is provided on the side wall of the frame near the elliptical opening and can reduce the radial support force of the proximal end of the thrombectomy frame. The introduction structure includes a plurality of corrugated mesh units. The corrugated mesh units have mesh boundaries formed by ribs and corrugated members. The corrugated members constitute the proximal or distal end of the corrugated mesh units, and the ribs are linear ribs.
6. The vascular thrombectomy stent according to claim 5, characterized in that: Along the direction from the proximal end to the distal end, the latter mesh portion can further peel off or capture residual thrombus relative to the former mesh portion.
7. A vascular thrombectomy frame, comprising a thrombectomy frame having a distal end and a proximal end, characterized in that: The thrombus removal frame is a mesh tube or cage-like structure with ribs; a narrowing portion formed by the transverse narrowing of the thrombus removal frame is provided between the distal end and the proximal end of the thrombus removal frame; the narrowing portion divides the thrombus removal frame into a first mesh portion and a second mesh portion for stripping or capturing thrombi, and the second mesh portion can further strip or capture residual thrombi relative to the first mesh portion; the ribs forming the thrombus removal frame have several pairs of connected ribs and form several first node units; the ribs forming the narrowing portion have several pairs of connected ribs and form several second node units element; a plurality of the second node units form a three-dimensional array capable of laterally intercepting free thrombus; the second node units have different connecting bridge lengths, and also include an introduction structure arranged on the proximal end of the thrombus removal frame, the proximal end of the thrombus removal frame is provided with an elliptical opening, the introduction structure is arranged on the side wall of the frame near the elliptical opening, and the introduction structure can reduce the radial support force of the proximal end section of the thrombus removal frame; the introduction structure includes a plurality of corrugated grid units, the corrugated grid unit is composed of ribs and corrugated members to form a grid boundary, wherein the corrugated members constitute the proximal section or distal section of the corrugated grid unit, and the ribs are straight ribs.
8. The vascular thrombectomy stent according to claim 7, characterized in that: The first grid portion and the second grid portion of the thrombus removal frame both have an outer contour that gradually increases in size from the proximal end to the distal end.
9. The vascular thrombectomy stent according to claim 7, characterized in that: The plurality of ribs at the proximal end of the thrombus removal frame have a wave-shaped structure.
10. The vascular thrombectomy stent according to claim 7, characterized in that: The proximal end of the thrombus removal frame has an open structure.
11. The vascular thrombectomy stent according to claim 7, characterized in that: The proximal end of the thrombus removal frame is connected to the manipulation component via a connecting rib.
12. The vascular thrombectomy stent according to claim 1, 5 or 7, characterized in that: It also includes a component with a planing function and is arranged on the thrombus removal frame.
13. The vascular thrombectomy stent according to claim 12, characterized in that: The component with the planing function is a rib on the thrombus removal frame, or a planing blade component separately provided with respect to the rib.
14. The vascular thrombectomy stent according to claim 1, 5 or 7, characterized in that: It also includes a structure for preventing the distal end of the thrombus from drifting, which is arranged on the distal end section of the thrombus removal frame.
15. The vascular thrombectomy stent according to claim 14, characterized in that: The structure for preventing the distal drift of the thrombus is one of an elastic membrane, an inelastic membrane, and a dense network structure, or a combination thereof.
16. The vascular thrombectomy stent according to claim 1, 5 or 7, characterized in that: It also includes a bundling portion disposed on the distal end of the thrombus removal frame.
17. The vascular thrombectomy stent according to claim 1, 5 or 7, characterized in that: The proximal end of the thrombus removal frame has multiple tendons, which are connected to the manipulation component through the bundle of tendons.
Citation Information
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