A venous filter and method of making the same

Abstract

The application discloses a kind of venous filter, comprising: filter body, including support, filter tendon and bundling tendon, filter tendon one end is connected through connecting tendon support, the other end of filter tendon is provided with bundling tendon;Binding rope is used for bundling fixed bundling tendon of filter body;Wherein, filter body is made of memory nickel-titanium alloy material, binding rope is degradable biological material rope or degradable magnesium alloy material silk, several filter tendons on filter body form funnel-shaped structure after bundling rope winding bundling tendon, funnel-shaped structure is used for intercepting thrombus block.The application also discloses a kind of as above-mentioned venous filter manufacturing method.Compared with prior art, the present application solves the problem that the existing venous filter cannot exist stably in the body after permanent implantation and reduce related complications.

Description

Technical Field

[0001] This invention relates to the field of vein filter technology, and more particularly to a vein filter and its manufacturing method. Background Technology

[0002] Deep vein thrombosis (DVT) is the process by which blood coagulates or certain formed elements in the blood aggregate to form a solid mass within deep veins, commonly occurring in peripheral veins. Pulmonary thromboembolism (PE) is a syndrome caused by an embolus detaching from a peripheral vein and traveling into the pulmonary circulation, blocking blood supply to the lungs and leading to cardiac and pulmonary dysfunction. DVT and PE are collectively referred to as venous thromboembolism (VTE). The incidence of VTE in the United States is approximately 300,000 to 600,000 cases per year, and PE causes 100,000 to 200,000 deaths annually in the US, making it a significant public health problem. Clinically, the incidence of sudden death from PE is approximately 5%, ranking third in incidence after coronary heart disease and hypertension, and third in mortality after cancer and myocardial infarction. Deep vein thrombosis (DVT) is a high-risk factor for pulmonary embolism (PE). Over 90% of PE emboli originate from lower extremity DVT, particularly DVT above the knee and proximal to the heart. When the embolic area exceeds 50%-80% of the pulmonary artery, it can very likely lead to sudden death. Studies have shown that small thrombi rarely cause PE; only when the thrombus diameter exceeds a certain range can PE occur. Previous clinical studies have shown that over 33% of patients with lower extremity DVT develop symptomatic PE, and 10% of symptomatic PE is fatal. However, in actual disease progression, most PE cases are asymptomatic, leading to high rates of misdiagnosis and missed diagnosis. Therefore, in clinical treatment, preventing PE is considered more important than treating PE itself.

[0003] An inferior vena cava filter (IVCF) is an implantable medical device similar to a filter, typically placed in the inferior vena cava. It effectively prevents deep vein thrombosis (DVT) from developing into physical embolism (PE) by physically blocking and intercepting floating blood clots. Since the advent of the Mobin-Uddin umbrella-shaped IVCF in 1967, its clinical application has become increasingly widespread, and it has become one of the main measures for preventing PE. Based on clinical use, three types of IVCFs have emerged, classified according to the implantation time as permanent, temporary, and retrievable IVCFs.

[0004] Intravenous filter (IVCF) was originally designed for permanent implantation, but a prospective randomized controlled trial followed patients with permanently implanted IVCFs for up to 8 years. The results showed that retrievable IVCFs helped reduce the risk of pulmonary embolism and long-term deep vein thrombosis (DVT) recurrence, thus spurring the development of retrievable IVCFs. Extensive clinical practice has shown that the longer a retrievable IVCF is left in place, the lower the success rate of removal. Therefore, in 2010, the US FDA emphasized the risks of long-term indwelling retrievable filters and recommended that when pulmonary embolism prevention is no longer needed, clinicians and the physician who implanted the filter should share responsibility for filter retrieval.

[0005] Intravenous catheters (IVCFs) are typically placed via the conventional femoral or jugular vein approach. Mild complications after placement include local hematoma / thrombosis and bleeding. The incidence of complications following IVCF placement is as follows: thrombosis (2%–30%), recurrence of pulmonary embolism (PE) after filter placement (0.5%–6%), filter breakage (2%–10%), filter embolism / displacement (2%–10%), and IVC penetration / perforation (0%–50%). For retrievable IVCFs, the main complications during retrieval include inferior vena cava thrombosis (4.3%) and inferior vena cava injury / tear (0.88%). Delayed IVCF removal increases the likelihood of filter adhesion to the vessel wall, correspondingly reducing retrieval success rate and increasing the risk of complications. Studies have shown that adhesion between IVCF and the vascular wall often occurs 9-12 weeks after implantation. Currently, the removal window for most retrievable IVCFs is usually within 14 days. However, in actual clinical practice, many patients cannot have their IVCFs removed due to endothelial hyperplasia and filter adhesion, and are forced to have permanent IVCFs. As a permanent implant, the filter may tilt, shift, embolize, break, or puncture blood vessels, which are often considered potential risks and require regular follow-up observation.

[0006] The mechanisms by which drugs inhibit endothelial cell proliferation and growth mainly include interference with nucleic acid biosynthesis, disruption and interference with DNA structure and function, and interference with cellular protein synthesis. Among these, angiostatin, isolated in 1997 from the culture medium of the mouse endothelioma cell line EOMA, is a protein that specifically inhibits the proliferation and migration of vascular endothelial cells. It exhibits significant inhibitory effects on vascular endothelial cell proliferation and migration, and can induce cell cycle arrest and apoptosis in vascular endothelial cells. Its inhibitory function is specific to vascular endothelial cells. With the deepening research on angiostatin, researchers have confirmed that nucleolar protein on the cell membrane surface is the receptor for angiostatin. Angiostatin inhibits the phosphorylation process of nucleolar protein, thereby inhibiting angiogenesis and tumor growth. In addition, vascular endothelial growth factor (VEGF) is also an important target for inhibiting endothelial cell proliferation. Drug development for anti-VEGF has progressed from the initial development of piperatanib sodium to monoclonal antibodies such as bevacizumab and ranibizumab, and later to antibody fusion proteins such as aflibercept and conbocept. More and more anti-VEGF drugs have been proven to have anti-vascular endothelial proliferation effects and have been shown to have therapeutic effects in clinical practice.

[0007] Widely used intravenous filters fall into three categories: permanent filters, removable filters (temporary / permanent dual-purpose filters), and temporary filters. Permanent intravenous filters were the earliest type of filter to be introduced and are now widely used in clinical practice.

[0008] Permanent venous filters have a conical filter body with barbs to secure it to the wall of the inferior vena cava and prevent displacement. However, due to the long-term implantation of permanent venous filters, complications such as inferior vena cava perforation, filter displacement, secondary thrombosis leading to inferior vena cava occlusion, and recurrence of inferior vena cava thrombosis may occur.

[0009] Removable venous filters are designed with barbs to secure them to the vein wall, and a small hook at the top for removal using a gooseneck catcher. They can be left in place permanently or temporarily. However, as temporary filters, their placement window is relatively short, generally a maximum of two weeks. Prolonged placement can cause the filter to adhere to the vessel wall, making removal difficult.

[0010] Temporary filters lack barbs and retaining claws to prevent damage to the vein wall, allowing for longer placement times, typically 4–6 weeks. However, they still require removal after implantation, posing a risk of filter displacement and the possibility of endothelialization leading to adhesion to the vessel wall and subsequent inability to remove them.

[0011] Currently, in the clinical treatment of PE prevention, there is a lack of venous filters that can inhibit endothelial cell attachment and growth, slow down vascular endothelial proliferation at the contact site, and be a permanent implant that can remain stably in the body and reduce related complications. Summary of the Invention

[0012] The purpose of this invention is to provide a venous filter and its manufacturing method to solve the problem that existing venous filters cannot be stably maintained in the body after permanent implantation and to reduce related complications.

[0013] To achieve the above objectives, in one respect, the present invention discloses a venous filter, comprising:

[0014] The filter body includes a support, filter ribs and binding ribs. One end of the filter ribs is connected to the support via connecting ribs, and the other end of the filter ribs is provided with binding ribs.

[0015] Binding rope, used to tie and secure the filter body;

[0016] The filter body is made of shape memory nickel-titanium alloy, and the binding rope is made of biodegradable biomaterial rope or biodegradable magnesium alloy wire. Several filter ribs on the filter body form a funnel-shaped structure after being wrapped with the binding rope. The binding method can be freely combined as needed. The funnel-shaped structure is used to intercept thrombus. Several cutting parts are arranged along the length of the filter rib. The cutting parts are saw teeth or cutting nails. When the thrombus passes through the funnel-shaped structure, it is caught by the saw teeth or cutting nails. Under the impact of blood flow, the saw teeth or cutting nails locally cut the surface of the thrombus. The saw teeth cut in the direction of thrombus flow. The thrombus is caught by the saw teeth or cutting nails and torn apart, so that the thrombus becomes thinner, smaller or decomposes into multiple pieces.

[0017] An independent loop is set at the through hole of each binding bar. The wire of the loop passes through one or two through holes. The wire of the loop can be connected end to end to form a closed loop, or the binding bar and the wire of the loop can be connected end to end through the through hole to form a closed loop. The binding rope made of biodegradable biomaterial rope or biodegradable magnesium alloy wire can be used to directly bind the loops on each binding bar together and tie them into a dead knot to form a funnel. The binding method can be freely combined as needed.

[0018] Biodegradable biomaterial rings or biodegradable magnesium alloy rings bind all the binding ribs together through heat shrinking or riveting processes, forming a funnel by binding the binding ribs and filter ribs. The biodegradable biomaterial rings or biodegradable magnesium alloy rings degrade in the human blood vessels, the funnel is opened, and the binding ribs and filter ribs return to their free state.

[0019] On the other hand, the present invention also discloses a method for manufacturing a vein filter as described above, comprising the following steps:

[0020] S1. The filter body support, filter ribs, and binding ribs are processed using an integrated laser cutting method;

[0021] S2. Grinding to form the cutting parts on the filter ribs, such as grinding the saw blades used to form the teeth;

[0022] S3. Twist each filter rib of the filter body by 90 degrees and heat treat to shape it into a spiral connecting rib.

[0023] S4. Pickling and polishing the processed filter;

[0024] S5. Tie the binding ribs with biodegradable binding rope or silk to form a funnel from the filter ribs. Alternatively, before binding the binding ribs, add loops to the binding ribs and then wrap and bind all the loops together to form a funnel from the filter ribs and binding ribs. Or, combine the filter ribs and binding ribs to form a funnel from the filter ribs and binding ribs by heat shrinking or riveting biodegradable material ring binding.

[0025] Furthermore, this invention also discloses a design scheme for a venous filter, comprising:

[0026] The filter body includes a support, filter ribs and binding ribs. One end of the filter ribs is connected to the support via a connecting rib, and the other end of the filter ribs is provided with binding ribs.

[0027] The filter body has a funnel-shaped structure at the filter ribs. The funnel-shaped structure is used to intercept thrombus. Several cutting parts are arranged along the length of the filter ribs. The cutting parts are saw teeth or cutting nails. When the thrombus passes through the funnel-shaped structure, it is caught by the saw teeth or cutting nails. Under the impact of the blood flow, the saw teeth or cutting nails locally cut the surface of the thrombus. The saw teeth cut in the direction of the thrombus flow. The thrombus is caught by the saw teeth or cutting nails and torn apart, so that the thrombus becomes thinner, smaller or decomposes into multiple thrombi.

[0028] The filter ribs have elastic deformation capabilities, which can not only cut thrombi, but also expand the funnel end of the filter ribs through elastic deformation, allowing thrombi that cannot be cut or torn to pass through.

[0029] The above method for manufacturing a venous filter includes the following steps:

[0030] S1. The filter body support, filter ribs, and binding ribs are processed using an integrated laser cutting method;

[0031] S2. Grinding to form the cutting parts on the filter ribs, such as grinding the saw blades used to form the teeth;

[0032] S3. Each filter rib of the filter body is twisted 90 degrees by a special mold and the filter rib is formed into a funnel shape and then heat-treated to shape it, forming a spiral connecting rib and a funnel-shaped filter rib.

[0033] S4. Pickling and polishing the processed filter.

[0034] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0035] 1. In this invention, when using the venous filter, the binding ribs at the end of the filter body are first tied with binding ropes, and then the entire filter is inserted into a human blood vessel. At this time, the support 7 of the filter body supports the inner wall of the blood vessel, and a funnel-shaped structure is formed at the filter ribs. When a thrombus in the blood vessel passes through this funnel, it is intercepted. The thrombus intercepted here is continuously flushed by the blood flow, causing the thrombus to be broken into smaller pieces, effectively eliminating the thrombus.

[0036] 2. In this invention, because the binding rope is made of biodegradable biomaterial rope or biodegradable magnesium alloy wire, the binding rope in the blood vessel degrades within a specified time, causing the binding tendon to be released and the filter body made of memory nickel-titanium alloy material to return to the open state. After the filter body opens, the funnel-shaped structure disappears and no longer functions as a filter, and it has no impact on blood vessels and blood flow. Therefore, it does not need to be removed, reducing the trouble of a second surgery. Attached Figure Description

[0037] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0038] Figure 1 This is a schematic diagram of the bundled structure of a vein filter scheme 1.

[0039] Figure 2 for Figure 1 A magnified view of a portion of point A in the middle.

[0040] Figure 3 This is a schematic diagram of the main view structure of a venous filter in a bundled state.

[0041] Figure 4 for Figure 3 A magnified view of a section at point B.

[0042] Figure 5 This is a schematic diagram of the left-side view of a bundled venous filter scheme.

[0043] Figure 6 This is a schematic diagram of the open state structure of a vein filter scheme 1.

[0044] Figure 7 A schematic diagram of the main view structure of a vein filter scheme in its open state. Figure 1 .

[0045] Figure 8 for Figure 7 A magnified view of a section at point C.

[0046] Figure 9 A schematic diagram of the main view structure of a vein filter scheme in its open state. Figure 2 .

[0047] Figure 10 for Figure 9 DD section view.

[0048] Figure 11 for Figure 9 A magnified view of a section at point E in the middle.

[0049] Figure 12 This is a schematic diagram of the main view structure of a second vein filter in its open state.

[0050] Figure 13 This is a schematic diagram of the main view structure of a vein filter scheme 3 in its open state.

[0051] Figure 14 This is a schematic diagram of the open state of a vein filter scheme four, viewed from the main perspective.

[0052] Legend:

[0053] 201. Independent reinforcement bar; 202. Corner reinforcement bar; 701. Support frame; 702. Filter reinforcement bar; 703. Tie reinforcement bar;

[0054] 801, Connecting rib; 1002, Cutting edge; 1001, Bevel; 1101, Serrated edge; 1102, Through hole;

[0055] 1201, ball head; 1301, warped head; 1401, flat square head. Detailed Implementation

[0056] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0057] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0058] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0059] In the description of the embodiments of the present invention, it should be noted that the terms "upper" and "inner" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the invention is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the present invention.

[0060] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0061] Example 1

[0062] Please see Figure 1-8 On one hand, the present invention discloses a vein filter, comprising:

[0063] The filter body includes a support 701, a filter rib 702 and a binding rib 703. One end of the filter rib 702 is connected to the support 701 through a connecting rib 801, which has a spiral structure. The other end of the filter rib 702 is provided with a binding rib 703.

[0064] Binding rope, which is used to bind and fix the filter body with binding rib 703;

[0065] The filter body is made of shape memory nickel-titanium alloy, and the binding rope is made of biodegradable biomaterial rope or biodegradable magnesium alloy wire. Several filter ribs 702 on the filter body form a funnel-shaped structure after the binding rope is wrapped around the binding rib 703. The funnel-shaped structure is used to intercept thrombus. The setting of the connecting rib 801 improves the deformation resistance at the connection between the support 701 and the filter rib 702, and at the same time allows the filter body to recover more quickly after the binding rope degrades.

[0066] On the other hand, the present invention also discloses a method for manufacturing a vein filter as described above, comprising the following steps:

[0067] S1. The filter body support 701, filter rib 702, and binding rib 703 are processed by integrated laser cutting.

[0068] S2. Grinding to form the cutting parts on the filter ribs, such as grinding the saw blades used to form the teeth;

[0069] S3. Twist each filter rib of the filter body by 90 degrees and heat treat to shape it into a spiral connecting rib.

[0070] S4. Pickling and polishing the processed filter;

[0071] S5. Tie the binding ribs with biodegradable binding rope or silk to form a funnel from the filter ribs. Alternatively, before binding the binding ribs, add loops to the binding ribs and then wrap and bind all the loops together to form a funnel from the filter ribs and binding ribs. Or, combine the filter ribs and binding ribs to form a funnel from the filter ribs and binding ribs by heat shrinking or riveting biodegradable material ring binding.

[0072] Depending on the specific form of the binding material, step S5 can involve various binding methods, as detailed below:

[0073] The first method: In step S5, the binding material is a biodegradable biomaterial rope or a biodegradable magnesium alloy wire, and the binding ribs are bound together to form a funnel.

[0074] The second method: In step S5, before the binding rib 703 is bound, loops are made on the binding rib 703, and all loops are wrapped and bound together so that the filter rib 702 and the binding rib 703 are bound together to form a funnel.

[0075] The third method: In step S5, the filter ribs 702 and the binding ribs 703 are bound together to form a funnel by heat shrinking or riveting biodegradable material rings.

[0076] Working principle: When using the intravenous filter, first use the binding rope to bind the binding rib 703 at the end of the filter body. The structure after binding can be seen in the attached document. Figure 1The binding rope is not shown in the figure. The whole filter is then inserted into a human blood vessel. At this time, the support 701 of the filter body supports the inner wall of the blood vessel, while the filter rib 702 forms a funnel-shaped structure. When the thrombus in the blood vessel passes through the funnel, it is intercepted. The thrombus intercepted here is continuously flushed by the blood flow, causing the thrombus to be broken into smaller pieces, effectively eliminating the thrombus.

[0077] Because the binding cord is made of biodegradable biomaterial cord or biodegradable magnesium alloy wire, specifically polymer materials or magnesium alloys, the binding cord in the blood vessel degrades within a specified time, causing the binding ligature 703 to release its restraints. The filter body, made of memory nickel-titanium alloy, then returns to its open state. See the appendix for details. Figure 6 Once the filter body is opened, the funnel-shaped structure disappears and no longer functions as a filter. It also has no impact on blood vessels or blood flow, so there is no need to remove it, reducing the hassle of a second surgery.

[0078] Example 2

[0079] Based on the above embodiments, this embodiment further improves upon the following technical solution: a through hole 1102 is provided on the binding rib 703.

[0080] The through hole 1102 allows the binding rope to pass through the through hole 1102 when binding the binding rib 703, in addition to directly wrapping the binding rib 703. The binding method can be freely combined as needed, thus further locking the binding rib 703 and improving the stability of the funnel-shaped structure at the filter rib 702.

[0081] To facilitate wrapping and eliminate the risk of breakage of biodegradable materials, this invention designs another binding method: an independent loop is set at the through hole 1102 of each binding rib 703. The wire of the loop passes through one or two through holes 1102. The wire of the loop can be connected end to end to form a closed loop, or the binding rib 703 and the loop wire can be connected end to end through the through hole 1102 to form a closed loop. The binding rope made of biodegradable biomaterial or biodegradable magnesium alloy wire directly binds the loops on each binding rib 703 together and ties them into a knot to form a funnel. The binding method can be freely combined as needed.

[0082] To facilitate wrapping and eliminate the risk of breakage of biodegradable materials, this invention designs an alternative heat-shrink or riveting method to replace the wrapping method: the biodegradable biomaterial ring or biodegradable magnesium alloy ring binds all the binding ribs 703 together through heat-shrink or riveting processes, so that the binding ribs 703 and the filter ribs 702 are bound to form a funnel. The biodegradable biomaterial ring or biodegradable magnesium alloy ring degrades in the human blood vessels, the funnel is opened, and the binding ribs 703 and the filter ribs 702 return to their free state.

[0083] Example 3

[0084] See appendix Figure 9-11 Based on the above embodiments, this embodiment further improves the technical solution as follows: a plurality of serrations 1101 are provided at the filter rib 702 along its own length direction, and the serrations 1101 include a cutting edge 1002 and an inclined surface 1001 extending from the root of the serration 1101 to the cutting edge 1002.

[0085] The filter rib 702 is equipped with serrations 1101 to improve the cutting and breaking-up effect of the filter rib 702 on the funnel-shaped structure. The serrations can also be made into hook-shaped sharp teeth. The function of the serrations is to catch the thrombus and cut the surface of the thrombus. Specifically, when the thrombus passes through the funnel, it is caught by the serrations. Under the impact force of the blood flow, the serrations locally cut the surface of the thrombus, causing the thrombus to become thinner, smaller, or break down into multiple pieces.

[0086] Furthermore, the shape of the serration 1101 is further improved, so that one side of the blade 1002 is a vertical surface and the other side is a bevel 1001, thereby improving the cutting effect on thrombi.

[0087] Sharp, protruding structures are required at filter rib 702 to cut thrombi and improve thrombus segmentation efficiency. Therefore, filter rib 702 can also be equipped with several cutting pins arranged along its length to achieve thrombus segmentation.

[0088] The cutting nail is a sharp-ended structure that protrudes from the surface of the filter rib 702, which allows the funnel of the filter body to firmly position the thrombus and uses the slender nail to divide the thrombus.

[0089] Example 4

[0090] Based on the above embodiments, the following improved technical solutions are further made in this embodiment: an independent rib 201 is provided at the end of the support 701 away from the binding rib 703. After the filter body is bound to form a funnel-shaped structure, a corner rib 202 is formed between the filter rib 702 and the binding rib 703. A developing element is sleeved on the independent rib 201, the connecting rib 801 and the corner rib 202.

[0091] During angiography, the position of the venous filter in the blood vessel can be accurately displayed through the contrast elements at the independent rib 201, connecting rib 801, and corner rib 202. Furthermore, the position of the contrast elements at the independent rib 201, connecting rib 801, and corner rib 202 can indicate whether the venous filter is in a bound or open state.

[0092] The developing element is a ring or a developing wire rolled into a spring-like structure. The developing element can be made of platinum alloy or tantalum alloy. The developing element is used to mark the positions of independent ribs 201, connecting ribs 801, and corner ribs 202. Its shape is not limited to the above-mentioned ring or spring-like structure. It can be made on the independent ribs 201, connecting ribs 801, and corner ribs 202.

[0093] Example 5

[0094] See appendix Figure 12-14 Based on the above embodiments, this embodiment further improves upon the following technical solution: one end of the binding rib 703 is provided with a ball head 1201, a warped head 1301, or a flat square head 1401.

[0095] See appendix Figure 12 The end of the binding rib 703 is provided with a ball head 1201. The blocking ability of the ball head 1201 makes it difficult for the biodegradable binding rope to slip off axially after the binding rib 703 is bound. The ball head 1201 can also prevent the blood vessel from being punctured after the venous filter is opened.

[0096] See appendix Figure 13 The design of the curved head 1301 at the end of the binding rib 703 allows the venous filter to be slowly inserted into the inner wall of the blood vessel after it is opened, making it less likely for the venous filter to shift axially.

[0097] See appendix Figure 14 The binding rib 703 has a flat square head 1401 at its end, and a through hole 1102 is provided at the flat square head 1401. On the one hand, when the biodegradable binding rope is wrapped around the binding rib 703, it can pass through the through hole 1102 on the flat square head 1401. The flat square head 1401 also acts as a blocking effect similar to the ball head 1201, making it difficult for the biodegradable binding rope to slip off axially. On the other hand, the through hole 1102 is provided at the flat square head 1401, which reduces the risk of breakage when the binding rib 703 has the through hole 1102, and improves the safety of the venous filter.

[0098] Example 6

[0099] Please see Figure 1 The present invention also discloses a vein filter, comprising:

[0100] The filter body includes a support, filter ribs and binding ribs. One end of the filter ribs is connected to the support via connecting ribs, and the other end of the filter ribs is provided with binding ribs.

[0101] The filter body has a funnel-shaped structure at the filter ribs. The funnel-shaped structure is used to intercept thrombus. Several cutting parts are arranged along the length of the filter ribs. The cutting parts are saw teeth or cutting nails. When the thrombus passes through the funnel-shaped structure, it is caught by the saw teeth or cutting nails. Under the impact of the blood flow, the saw teeth or cutting nails locally cut the surface of the thrombus. The saw teeth cut in the direction of the thrombus flow. The thrombus is caught by the saw teeth or cutting nails and torn apart, so that the thrombus becomes thinner, smaller or decomposes into multiple pieces of thrombus.

[0102] The filter ribs have elastic deformation capabilities, which can not only cut thrombi, but also expand the funnel end of the filter ribs through elastic deformation, allowing thrombi that cannot be cut or torn to pass through.

[0103] The above method for manufacturing a venous filter includes the following steps:

[0104] S1. The filter body support, filter ribs, and binding ribs are processed using an integrated laser cutting method;

[0105] S2. Grinding to form the cutting parts on the filter ribs, such as grinding the saw blades used to form the teeth;

[0106] S3. Each filter rib of the filter body is twisted 90 degrees by a special mold and the filter rib is formed into a funnel shape and then heat-treated to shape it, forming a spiral connecting rib and a funnel-shaped filter rib.

[0107] S4. Pickling and polishing the processed filter.

[0108] Vein filters can also be directly processed into, for example Figure 1 The shape obtained by binding is shown, without the need for binding rope to fix the shape. When encountering a large thrombus, the filter rib 702 deforms under the impact force of the thrombus, and the filter rib 702 expands towards the blood vessel wall, allowing large blood clots to pass freely. The filter rib is elastic, which can not only cut the thrombus, but also elastically deform to expand the funnel end of the filter rib, allowing thrombi that cannot be cut or torn to pass through, thus avoiding blockage at the funnel end of the filter rib and ensuring smooth blood flow.

[0109] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A vein filter, characterized in that, include: The filter body includes a support, filter ribs and binding ribs. One end of the filter ribs is connected to the support via a connecting rib, and the other end of the filter ribs is provided with the binding ribs. Binding rope, used to tie and secure the binding ribs of the filter body; The filter body is made of shape memory nickel-titanium alloy, and the binding rope is made of biodegradable biomaterial rope or biodegradable magnesium alloy wire. Several filter ribs on the filter body form a funnel-shaped structure after the binding rope is wrapped around the binding ribs. The funnel-shaped structure is used to intercept thrombus. Several cutting elements are arranged along the length of the filter ribs. The cutting elements are saw teeth or cutting nails. When the thrombus passes through the funnel-shaped structure, it is caught by the saw teeth or cutting nails. Under the impact of blood flow, the saw teeth or cutting nails locally cut the surface of the thrombus. The saw teeth cut in the direction of thrombus flow. The thrombus is caught by the saw teeth or cutting nails and torn apart, so that the thrombus becomes thinner, smaller or decomposes into multiple thrombus pieces.

2. A vein filter according to claim 1, characterized in that, The connecting ribs have a spiral structure to facilitate the processing of saw teeth and to improve the deformation resistance at the connection between the support and the filter ribs, as well as the recovery speed after the binding rope degrades.

3. A vein filter according to claim 1, characterized in that, The binding ribs are provided with through holes for the binding rope to pass through. Alternatively, an independent loop can be provided at the through hole of each binding rib, with the wire of the loop passing through at least one through hole. The ends of the loop wires are connected to each other to form a closed loop. Alternatively, the binding ribs and loop wires can be connected end to end through the through holes to form a closed loop. The binding rope made of biodegradable biomaterial rope or biodegradable magnesium alloy wire can be used to bind the loops on each binding rib together and tie them into a knot to form a funnel. Alternatively, the biodegradable biomaterial ring or biodegradable magnesium alloy ring can be used to bind all the binding ribs together through heat shrinking or riveting processes, so that the binding ribs and filter ribs are bound to form a funnel. The biodegradable biomaterial ring or biodegradable magnesium alloy ring degrades in the human blood vessels, the funnel is opened, and the binding ribs and filter ribs return to their free state.

4. A vein filter according to claim 1, characterized in that, The saw teeth include a cutting edge and an inclined surface extending from the root of the saw teeth toward the cutting edge.

5. A vein filter according to claim 1, characterized in that, An independent rib is provided at the end of the support away from the binding rib. After the filter body is bound to form the funnel-shaped structure, a corner rib is formed between the filter rib and the binding rib. A developing element is sleeved on the independent rib, the connecting rib and the corner rib.

6. A vein filter according to claim 5, characterized in that, The developing element is a ring or a developing filament wound into a spring-like structure.

7. A vein filter according to claim 1, characterized in that, One end of the binding bar is provided with a ball head, a warped head, or a flat square head.

8. A method for manufacturing a vein filter as described in any one of claims 1-7, characterized in that, Includes the following steps: S1. The filter body support, filter ribs, and binding ribs are processed using an integrated laser cutting method; S2, Grinding to form the cut parts on the filter ribs; S3. Twist each filter rib of the filter body by 90 degrees and heat treat to shape it into a spiral connecting rib. S4. Pickling and polishing the processed filter; S5. Bind the binding ribs with biodegradable binding rope or silk to form a funnel from the filter ribs, or add loops to the binding ribs before binding them, and then wrap all the loops together to form a funnel from the filter ribs and binding ribs, or combine the filter ribs and binding ribs to form a funnel from the filter ribs and binding ribs by heat shrinking or riveting biodegradable material ring binding.

9. A vein filter, characterized in that, include: The filter body includes a support, filter ribs and binding ribs. One end of the filter ribs is connected to the support via a connecting rib, and the other end of the filter ribs is provided with the binding ribs. The filter body forms a funnel-shaped structure at the filter ribs, which is used to intercept thrombus. Several cutting elements, which are saw teeth or cutting nails, are arranged along the length of the filter ribs. When the thrombus passes through the funnel-shaped structure, it is caught by the saw teeth or cutting nails. Under the impact of the blood flow, the saw teeth or cutting nails locally cut the surface of the thrombus. The saw teeth cut in the direction of the thrombus flow. The thrombus is caught by the saw teeth or cutting nails and torn apart, so that the thrombus becomes thinner, smaller or decomposes into multiple pieces. The filter ribs have elastic deformation capabilities, which can not only cut thrombi, but also expand the funnel end of the filter ribs through elastic deformation, allowing thrombi that cannot be cut or torn to pass through.

10. A method for manufacturing a vein filter as described in claim 9, characterized in that, Includes the following steps: S1. The filter body support, filter ribs, and binding ribs are processed using an integrated laser cutting method; S2, Grinding to form the cut parts on the filter ribs; S3. Each filter rib of the filter body is twisted 90 degrees by a special mold and the filter rib is formed into a funnel shape and then heat-treated to shape it, forming a spiral connecting rib and a funnel-shaped filter rib. S4. Pickling and polishing the processed filter.

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