Intracavity anchor, preparation method thereof and blood vessel occlusion device

Abstract

The invention discloses an intracavity anchor, a preparation method thereof and a blood vessel occlusion device. Relates to the technical field of medical instruments, in particular to an intracavity anchor which comprises an anchor body and a medicine carrying coating, the surface of the anchor body is coated with the medicine carrying coating, and the medicine carrying coating comprises at least one of anti-platelet adhesion medicine, anti-coagulation medicine, anti-proliferation medicine and anti-infection medicine. The intracavitary anchor provided by the invention has excellent anticoagulation, anti-proliferation and anti-infection capabilities, can effectively reduce the generation of clinical complications, avoids the need of long-term medicine taking of patients, reduces the pain and risk of the patients during treatment, and further enables the vascular structure and function to recover to a healthy state as soon as possible.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an intracavitary anchor and a preparation method thereof, and a blood vessel occluding device. Background Art

[0002] Femoral artery puncture is the main puncture route for peripheral interventional surgery, and hemostasis at the puncture site is always an issue that cannot be ignored in interventional surgery. Currently, vascular occluders are usually used to stop bleeding at the puncture site, that is, absorbable sponge plugs are pushed to the outside of the puncture site to assist in coagulation, or the puncture site is closed with a metal closure clip.

[0003] Traditional vascular occluders are only suitable for 5-7F arterial punctures. During use, the sponge plug outside the puncture point has limited coagulation ability on the puncture. For this reason, a degradable vascular occluder can be used, which uses an intraluminal anchor to block and position the inner wall of the blood vessel, and cooperates with an extraluminal locker to close the puncture from the outside of the blood vessel through the intraluminal anchor-vascular wall-sponge plug. This type of vascular occluder can be completely degraded and can also be used to close arterial punctures larger than 7F.

[0004] According to current clinical observations, the major complications of the puncture site after the use of the occluder include: hematoma, arterial damage (arterial stenosis, embolism, thrombosis), pseudoaneurysm, arteriovenous fistula, infection, etc. In order to prevent blood from gathering on the surface of the implant to form thrombus and arterial stenosis, long-term use of antiplatelet and anticoagulant drugs is required. In addition, persistent inflammation of the wound and improper operation during and after surgery also have the risk of infection. These complications can cause disability or even death in patients when they are severe. However, the vascular occlusion devices currently on the market do not have anticoagulation, antiproliferation and anti-infection functions. Summary of the invention

[0005] The main purpose of the present invention is to propose an intracavitary anchor and a preparation method thereof, and a vascular occlusion device to solve the technical problem that the vascular occlusion devices currently on the market cause clinical complications due to their anticoagulant, antiproliferative and anti-infection functions.

[0006] To achieve the above-mentioned purpose, the present invention proposes an intracavitary anchor, which is applied to a vascular occlusion device. The intracavitary anchor includes an anchor body and a drug-loaded coating coated on the surface of the anchor body, and the drug-loaded coating includes at least one of antiplatelet adhesion drugs, anticoagulant drugs, antiproliferative drugs and anti-infective drugs.

[0007] In some embodiments, the density of the drug in the drug-loaded coating is 0.1-10 μg / mm 2 ; and / or, the thickness of the drug-loaded coating is 10-20 μm.

[0008] In some embodiments, the anchor body is made of absorbable polymer material or absorbable metal material; and / or the wall thickness of the anchor body is 0.1-0.15 mm.

[0009] The present invention also provides a method for preparing the intracavitary anchor as described above, the method comprising the following steps:

[0010] preparing an anchor body;

[0011] A drug solution is prepared and coated on the surface of the anchor body to form a drug-loaded coating, thereby obtaining the intracavitary anchor.

[0012] In some embodiments, the step of preparing the drug solution comprises:

[0013] The drug, dopamine, oxidant, buffer and solvent are weighed according to the proportion, stirred and mixed to obtain a drug solution, wherein the concentration of the drug is 0.5-5wt%, the concentration of the dopamine is 1-10mg / L, the concentration of the buffer is 0.5-1.5mol / L; and the concentration of the oxidant is 1-1.5mg / L.

[0014] In some embodiments, the buffer comprises at least one of tris, bicarbonate, and phosphate; and / or,

[0015] The oxidant comprises at least one of (NH4)2S2O8, NaIO4, CuSO4, H2O2, KMnO4; and / or,

[0016] The stirring and mixing temperature is 20-37°C, and the stirring and mixing time is 2-8h.

[0017] In some embodiments, the step of coating the drug solution on the surface of the anchor body to form a drug-loaded coating comprises:

[0018] The drug solution is coated on the surface of the anchor body by immersion, transfer, spraying or spin coating;

[0019] The anchor body with the drug-loaded coating is immersed in a solution containing a reducing agent and an initiator, the pH value of the solution is adjusted, an oscillation reaction is performed, and then ultraviolet light curing, cleaning and drying are performed in sequence to obtain the intracavitary anchor.

[0020] In some embodiments, the reducing agent is sodium cyanoborocyanide, and the concentration of the reducing agent is 0.1-2.5 wt %; and / or,

[0021] The pH value is 4.5-6; and / or,

[0022] The temperature of the oscillation reaction is 20-40° C., the time of the oscillation reaction is 2-6 hours, and the time of the UV curing is 1-60 minutes; and / or,

[0023] The photoinitiator includes one or more of ruthenium pyridine complex, eosin Y, camphorquinone, and lithium phenyl-2,4,6-trimethylbenzoylphosphinate, and the content of the photoinitiator is 0.1-0.5 wt % of the mass of the dopamine.

[0024] In some embodiments, before the step of coating the drug solution on the surface of the anchor body to form a drug-loaded coating, the method further comprises:

[0025] The anchor body is surface treated to form a rough surface.

[0026] The present invention further provides a vascular occlusion device, which includes the intracavitary anchor as described above, or includes the intracavitary anchor prepared by the method for preparing the intracavitary anchor as described above.

[0027] The technical solution provided by the present invention improves the intracavitary anchor of the vascular occlusion device, and coats the surface of the anchor body with a drug-loaded coating, wherein the drug-loaded coating includes at least one of antiplatelet adhesion drugs, anticoagulant drugs, antiproliferative drugs and anti-infective drugs. Thus, after the intracavitary anchor is implanted in the human body, it has excellent anticoagulant, antiproliferative and anti-infective capabilities, can effectively reduce the occurrence of clinical complications, eliminate the need for patients to take long-term medication, reduce the pain and risks of patients during treatment, and thereby restore the vascular structure and function to a healthy state as soon as possible. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. 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 the structures shown in these drawings without paying creative work.

[0029] Figure 1 A schematic diagram of the shape of the anchor body in the intracavitary anchor provided by the present invention;

[0030] Figure 2 A schematic diagram of the surface roughening structure of the anchor body after mechanical processing in the intracavitary anchor provided by the present invention;

[0031] Figure 3 A schematic diagram of the surface roughening structure of the anchor body after chemical etching in the intracavitary anchor provided by the present invention;

[0032] Figure 4 A comparison diagram of the adhesion force of the anchor body to vascular endothelial cells before and after the surface roughening process in the intracavitary anchor provided by the present invention;

[0033] Figure 5 A schematic diagram of drug sustained release of an anchor body coated with a rapamycin drug-loaded coating within 720 hours in the intracavitary anchor provided by the present invention;

[0034] Figure 6 A schematic diagram of the structure of the blood vessel occlusion device provided by the present invention;

[0035] Figure 7 for Figure 6 A schematic diagram of the enlarged structure at A in the middle;

[0036] Figure 8 A schematic structural diagram of the intracavitary anchor in the blood vessel occlusion device provided by the present invention from another perspective;

[0037] Fig. 9 for Figure 8 Schematic diagram of the cross-section structure along line BB;

[0038] Fig.10 A schematic diagram of the connection structure of the suture, sponge plug and intracavitary anchor in the vascular occlusion device provided by the present invention;

[0039] Fig.11 A schematic structural diagram of a lock in the blood vessel occluding device provided by the present invention from another perspective;

[0040] Fig.12 for Fig.11 Schematic diagram of the cross-sectional structure along the CC line;

[0041] Fig.13 A schematic diagram of a state in which a puncture port is closed by the blood vessel occlusion device provided by the present invention;

[0042] Fig.14 A schematic diagram of the state of the blood vessel occlusion device provided by the present invention after the operation is completed;

[0043] Fig.15 This is a schematic diagram of the state of the blood vessel occluding device provided by the present invention after occlusion is completed.

[0044] Description of Figure Numbers:

[0045] 100. implant component; 10. suture; 11. slipknot; 20. buckle; 21. raised structure; 30. sponge plug; 31. through hole A; 32. through hole B; 33. through hole C; 34. through hole D; 35. through hole E; 36. through hole F; 40. intracavitary anchor; 50. locking push tube; 400. drug-loaded coating; 401. first through hole; 402. second through hole; 60. subcutaneous tissue; 61. blood vessel wall; 62. puncture port.

[0046] The realization of the purpose, functional features and advantages of the present invention will be further explained in conjunction with embodiments and with reference to the accompanying drawings. DETAILED DESCRIPTION

[0047] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. 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 creative work are within the scope of protection of the present invention.

[0048] It should be noted that all directional indications in the embodiments of the present invention (such as up, down, left, right, front, back, etc.) are only used to explain the relative position relationship, movement status, etc. between the components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0049] In the present invention, unless otherwise clearly specified and limited, the terms "connection", "fixation", etc. should be understood in a broad sense. For example, "fixation" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0050] In addition, in the present invention, descriptions such as "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In addition, the technical solutions between the various embodiments can be combined with each other, but they must be based on the ability of ordinary technicians in the field to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0051] In order to solve the technical problem that the current vascular occlusion devices on the market may cause clinical complications due to their anticoagulant, antiproliferative and anti-infective functions, the present invention provides an intracavitary anchor 40, which is applied to the vascular occlusion device. The intracavitary anchor 40 is mainly used to fit with the inner side of the blood vessel to seal the puncture port from the inside of the blood vessel.

[0052] In one embodiment of the present invention, the intracavitary anchor 40 includes an anchor body and a drug-loaded coating 400 coated on the surface of the anchor body, and the drug-loaded coating 400 includes at least one of antiplatelet adhesion drugs, anticoagulant drugs, antiproliferative drugs and anti-infective drugs.

[0053] See also Figure 1 , Figure 1 is a schematic diagram of the shape of the anchor body. Figure 1 It can be seen that the anchor body has various shapes, which are not limited here.

[0054] In the present invention, the antiplatelet adhesion drugs include one or more of aspirin, clopidogrel, ticagrelor, tirofiban, cilostazol, dipyridamole, prostaglandins, dipyridamole, etc.; the anticoagulant drugs include one or more of heparin, hirudin, dicoumarol, warfarin sodium, antagonist vitamin K, etc.; the antiproliferative drugs include one or more of rapamycin and its derivatives, paclitaxel, dexamethasone, docetaxel, probucol, colchicine, etc.; the anti-infective drugs include one or more of penicillins, cephalosporins, atypical β-lactams, aminoglycosides, macrolides, tetracyclines, etc.

[0055] The present invention improves the intracavitary anchor 40 of the vascular occlusion device, and coats the surface of the anchor body with a drug-loaded coating 400, wherein the drug-loaded coating 400 includes at least one of antiplatelet adhesion drugs, anticoagulant drugs, antiproliferative drugs and anti-infective drugs. Thus, after the intracavitary anchor 40 is implanted in the human body, it has excellent anticoagulant, antiproliferative and anti-infective capabilities, which can effectively reduce the occurrence of clinical complications, eliminate the need for patients to take long-term medication, reduce the pain and risks of patients during treatment, and thereby restore the vascular structure and function to a healthy state as soon as possible.

[0056] In an optional embodiment of the present invention, the density of the drug in the drug-carrying coating 400 is 0.1-10 μg / mm 2 (For example, 0.1 μg / mm 2 , 1μg / mm 2 , 2μg / mm 2 , 5μg / mm 2 , 8μg / mm 2 , 10μg / mm 2and the interval value between any two end point values); the drug-loaded coating 400 selected within the above drug density range has relatively excellent anticoagulant, antiproliferative and anti-infection capabilities.

[0057] In an optional embodiment of the present invention, the thickness of the drug-loaded coating 400 is 10-20 μm (for example, 10 μm, 12 μm, 15 μm, 18 μm, 20 μm and an interval value between any two end points); the use of the drug-loaded coating 400 of the above thickness can not only ensure relatively excellent anti-coagulation, anti-proliferation and anti-infection capabilities, but also ensure that the overall volume of the intracavitary anchor 40 is not too large.

[0058] In an optional embodiment of the present invention, the anchor body is made of an absorbable polymer material or an absorbable metal material.

[0059] The absorbable polymer material includes one or more of polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polypropyl acetate, polydioxane, polydioxanone, polyhydroxyalkanoate, polytrimethylene carbonate, polyurethane, and polyether urethane. The absorbable metal material includes one or more of magnesium alloy, iron alloy, and zinc alloy.

[0060] In an optional embodiment of the present invention, the wall thickness of the anchor body is 0.1-0.15 mm (such as 0.1 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm and interval values ​​between any two end points).

[0061] The present invention also provides a method for preparing the intracavitary anchor 40 as described above, the method comprising the following steps:

[0062] preparing an anchor body;

[0063] A drug solution is prepared and coated on the surface of the anchor body to form a drug-loaded coating 400 , thereby obtaining the intracavitary anchor 40 .

[0064] In some embodiments of the present invention, the specific operation of preparing the anchor body is: vacuum drying the main body raw material, in a protective gas (such as nitrogen) atmosphere, through a melt extrusion process, cooling and molding to obtain the anchor body.

[0065] In some specific embodiments of the present invention, the material of the anchor body is an absorbable polymer material, and the specific preparation method thereof is as follows:

[0066] One or more of the above-mentioned absorbable polymer materials are vacuum dried at 30-60°C (such as 30°C, 40°C, 50°C, 60°C and any interval between the two end points) for 2-12h (such as 2h, 4h, 6h, 8h, 10h, 12h and any interval between the two end points), and the heating chamber temperature is set to 150-200°C (such as 150°C, 160°C, 170°C, 180°C, 190°C, 200°C and any interval between the two end points) under a protective atmosphere to obtain the absorbable polymer anchor body by compression molding, extrusion molding, injection molding, calendering molding, secondary molding and the like.

[0067] In some specific embodiments of the present invention, the anchor body is made of absorbable metal material, and the specific preparation method thereof is as follows:

[0068] From one or more of the absorbable metal materials, metal particles with a particle size range of 10-100 μm are screened, and smelted in a resistance furnace according to the designed composition ratio under a protective atmosphere, and the alloy melt is infiltrated into the template gap in a negative pressure infiltration device, and demolded after natural cooling, and the absorbable metal anchor body is obtained by machining;

[0069] In some embodiments of the present invention, the step of preparing the drug solution includes:

[0070] The drug, dopamine, oxidant, buffer and solvent are weighed according to the proportion, stirred and mixed to obtain a drug solution, wherein the concentration of the drug is 0.5-5wt% (for example, 0.5wt%, 1wt%, 2wt%, 3wt%, 4wt%, 5wt% and the interval between any two endpoints), the concentration of dopamine is 1-10mg / L (for example, 1mg / L, 3mg / L, 5mg / L, 8mg / L, 10mg / L and the interval between any two endpoints), the concentration of the buffer is 0.5-1.5mol / L (for example, 0.5mg / L, 1mg / L, 1.5mg / L and the interval between any two endpoints); the concentration of the oxidant is 1-1.5mg / L (for example, 1mg / L, 1.2mg / L, 1.5mg / L and the interval between any two endpoints).

[0071] In an optional embodiment of the present invention, the buffer comprises at least one of tris(hydroxymethyl)aminomethane (Tris), bicarbonate, and phosphate.

[0072] In an optional embodiment of the present invention, the oxidant includes at least one of (NH4)2S2O8, NaIO4, CuSO4, H2O2, and KMnO4.

[0073] In an optional embodiment of the present invention, the solvent is water or an alcohol solvent.

[0074] In an optional embodiment of the present invention, the stirring and mixing temperature (i.e., the dissolution temperature) is 20-37°C (e.g., 20°C, 25°C, 30°C, 35°C, 37°C, and any interval between the two end points), and the stirring and mixing time (i.e., the dissolution time) is 2-8h (e.g., 2h, 4h, 6h, 8h, and any interval between the two end points).

[0075] In an optional embodiment of the present invention, the drug solution is coated on the surface of the anchor body by immersion, transfer, spraying or spin coating to form a drug-loaded coating 400. The operation method is relatively simple, the cost is low, and the production efficiency is high.

[0076] In a specific embodiment of the present invention, the specific operation of preparing the drug-loaded coating 400 includes the following steps:

[0077] The anchor body is immersed in the drug solution, and the dopamine polymerization and deposition reaction is carried out in an alkaline environment. After the deposition is completed, it is washed with deionized water. Among them, the alkaline environment pH is 8.5, the deposition temperature is 20-37°C (such as 20°C, 25°C, 30°C, 35°C, 37°C and the interval between any two end points), and the deposition time is 8-36h (such as 8h, 15h, 25h, 36h and the interval between any two end points); it is washed with deionized water 2-3 times and blown dry with nitrogen for 1-5min (such as 1min, 2min, 3min, 4min, 5min and the interval between any two end points).

[0078] In some embodiments of the present invention, after the step of coating the drug solution on the surface of the anchor body to form the drug-loaded coating 400, the following steps are further included:

[0079] The anchor body with the drug-carrying coating 400 is immersed in a solution containing a reducing agent and an initiator, the pH value of the solution is adjusted, an oscillation reaction is performed, and then UV curing, cleaning and drying are performed in sequence to obtain the intracavitary anchor 40.

[0080] Specifically, the reducing agent may be sodium cyanoborocyanide, the concentration of the reducing agent is 0.1-2.5wt% (such as 0.1wt%, 0.5wt%, 1wt%, 1.5wt%, 2wt%, 2.5wt% and any interval between the two end points); the pH value is 4.5-6; the temperature of the oscillation reaction is 20-40°C (such as 20°C, 25°C, 30°C, 35°C, 40°C and any interval between the two end points), and the oscillation reaction time is 2-6h (such as 2h, 3h, 4h, 5h, 6h and any interval between the two end points). The UV curing time is 1-60min (such as 1min, 20min, 30min, 40min, 50min, 60min and the interval between any two endpoints); the photoinitiator includes one or more of ruthenium pyridine complex, eosin Y and camphorquinone, phenyl-2,4,6-trimethylbenzoyl lithium phosphinate, and the content of the photoinitiator is 0.1-0.5wt% of the mass of the dopamine (such as 0.1wt%, 0.2wt%, 0.3wt%, 0.4wt%, 0.5wt% and the interval between any two endpoints). The cleaning and drying are specifically as follows: after cleaning with deionized water, blow dry with nitrogen for standby use; wherein, the deionized water is cleaned 2-3 times, and the nitrogen drying time is 1-5min (such as 1min, 2min, 3min, 4min, 5min and the interval between any two endpoints).

[0081] Furthermore, in some embodiments of the present invention, before the step of coating the drug solution on the surface of the anchor body to form the drug-loaded coating 400, the step further includes:

[0082] The anchor body is surface treated to form a rough surface.

[0083] The present invention improves the surface roughness of the anchor body by mechanical or chemical abrasion process before coating the drug, which improves the adhesion of the drug-loaded coating 400 on the one hand, and is beneficial to the attachment, growth and proliferation of vascular endothelial cells on the other hand.

[0084] In a specific embodiment of the present invention, the roughness of the surface of the anchor body can be adjusted by mechanical or chemical abrasion process. The specific method can adopt one or more processes such as plasma etching, laser etching, corona discharge, electron beam lithography, chemical etching, etc., and control the roughness range within 0.1-20μm.

[0085] See also Figure 2 , Figure 2 is a schematic diagram of the surface roughening structure of the anchor body after mechanical processing. Figure 2It can be seen that the roughened structure of the anchor body after surface treatment can be circular protrusions, circular depressions, square protrusions, square depressions, diamond protrusions, diamond depressions or depressions or protrusions of other shapes, without limitation here, as long as the surface roughness can be achieved within 0.1-20μm.

[0086] See also Figure 3 , Figure 3 Schematic diagram of the surface roughening structure of the anchor body after chemical etching, where time is the chemical etching time. Figure 3 It can be seen that as the chemical etching time of the surface of the anchor body increases, the surface coarsening structure becomes more and more obvious, that is, the surface roughness becomes larger and larger.

[0087] See also Figure 4 , Figure 4 The following is a comparison of the adhesion of the anchor body to vascular endothelial cells before and after surface roughening, where 5 μm roughening and 15 μm roughening refer to the surface roughness of 5 μm and 15 μm respectively after roughening. Figure 4 It can be seen that the surface roughening structure of the anchor body has an obvious proliferation-promoting effect on vascular endothelial cells.

[0088] See also Figure 5 , Figure 5 A drug-loaded coating 400 is coated on the surface of the anchor body, and a schematic diagram of drug sustained release within 720 hours is shown, wherein the drug in the drug-loaded coating 400 is rapamycin, and its drug density is 3.5 μg / mm 2 , the thickness of the drug-carrying coating 400 is 15 μm. Figure 5 It can be seen that the rapamycin-loaded coating 400 is released at a slow and uniform rate within 720 hours, which does not cause high-concentration drug stimulation to the wound and can achieve a long-term and stable treatment effect.

[0089] The present invention uses the most widely used polydopamine drug-carrying coating 400, which can be deposited on the surface of almost any material. This method is mature and stable, will not change due to changes in the substrate, and is widely applicable.

[0090] The present invention further provides a blood vessel occlusion device, comprising the intracavitary anchor 40 as described above.

[0091] See also Figure 6 and Figure 7 In one embodiment of the present invention, the vascular occlusion device includes an implant component 100, a suture 10 and a locking push tube 50, wherein the implant part includes a lock buckle 20, a sponge plug 30 and an intracavitary anchor 40.

[0092] The buckle 20 is used to pass through the suture 10 with a slipknot 11 and has a developing property. The buckle 20 can be made of one or more materials such as cobalt-based alloy, titanium-based alloy, stainless steel, shape memory alloy, precious metal, pure metal niobium, zirconium, titanium, tantalum, etc.

[0093] The sponge plug 30 is used for rapid hemostasis, absorbing blood and tissue exudate, and fitting to the outside of the blood vessel to seal the puncture port 62 from the outside of the blood vessel. The material of the sponge plug 30 can be selected from one or more absorbable materials such as chitosan, cellulose, gelatin, starch, graphene oxide, hyaluronic acid, alginate, polyethylene glycol, silk fibroin, mesoporous silica nanoparticles, silica nanoparticles, etc. The sponge plug 30 is prepared by one or more preparation methods such as 3D printing, freeze-thaw method, microfiber aggregation, fiber bonding and winding, freeze drying, salt elution, gas foaming, phase separation, emulsion freeze drying, particle sintering, etc.

[0094] The intracavitary anchor 40 is connected to the sponge plug 30 and the extracavitary locker in sequence through sutures 10, and is used to fit the inner side of the blood vessel and seal the puncture port 62 from the inner side of the blood vessel. The intracavitary anchor 40 includes an anchor body and a drug-carrying coating 400 on the surface. The specific material and thickness of the drug-carrying coating 400 can be referred to the above embodiment, and will not be described one by one here.

[0095] The suture 10 is used to connect the intracavitary anchor 40 and the sponge plug 30. The suture 10 passes through one side of the sponge plug 30, then passes through the intracavitary anchor 40, and then passes back to the other side of the sponge plug 30; the suture 10 on both sides of the sponge plug 30 is tied with a slipknot 11 to tighten and fix the intracavitary anchor 40 and the sponge plug 30. The material of the suture 10 can be selected from one or more non-absorbable materials such as silk, nylon, polypropylene, polyester fiber, or one or more absorbable materials such as goat intestine, polyglycolic acid, lactide and glycolide polymer, glycolide and caprolactone polymer, polydioxanone, etc. The braiding mode of the suture 10 can be selected as single strand or multiple strands.

[0096] The locking push tube 50 is used to push the slipknot 11 at the front end of the lock buckle 20 to tighten the suture 10 connecting the intracavitary anchor 40 and the sponge plug 30, so that the intracavitary anchor 40 fits the inside of the blood vessel, and the sponge plug 30 fits the outside of the blood vessel, and the puncture port 62 is closed from the outside of the blood vessel in the manner of the intracavitary anchor 40-blood vessel wall 61-sponge plug 30. The material of the locking push tube 50 can be selected from one or more materials such as polyethylene, polypropylene, polyvinyl chloride, polyurethane, polytetrafluoroethylene, polycarbonate, polystyrene, acrylonitrile-butadiene-styrene graft copolymer, etc.

[0097] See also Figure 8 and Fig. 9The surface of the anchor body is treated with a rough coating and then coated with a drug-carrying coating 400. The anchor body is provided with a first through hole 401 and a second through hole 402 that penetrate through the two surfaces, for the suture 10 to be inserted and fixed.

[0098] See also Fig.10 , Fig.10 It is a schematic diagram of the connection structure between the suture 10, the sponge plug 30 and the intracavitary anchor 40, wherein the sponge plug 30 corresponds to three groups of through holes, namely, through hole A 31, through hole B 32, through hole C 33, through hole D 34, through hole E 35 and through hole F 36, wherein through hole C 33 and through hole D 34 are the first group, which are respectively arranged corresponding to the first through hole 401 and the second through hole 402, through hole A 31 and through hole B 32 are the second group, through hole E 35 and through hole F 36 are the third group, and the second group and the third group are arranged correspondingly, and are arranged corresponding to through hole C 33 and through hole D 34, respectively. The suture 10 passes through one side of the sponge plug 30, exits from the A through hole 31, enters the B through hole 32, and then exits from the C through hole 33. After passing through the first through hole 401 and the second through hole 402 on the intracavitary anchor 40 in sequence, it enters from the D through hole 34, exits from the E through hole 35, and then enters from point F.

[0099] See also Fig.11 and Fig.12 In one embodiment of the present invention, a protrusion structure 21 is provided inside the lock buckle 20, which is mainly used to prevent the suture 10 from relative movement (or sliding) during the pushing process of the lock buckle 20.

[0100] See also Fig.13 , Fig.13 The diagram is a state diagram of the occluder closing the puncture port 62. The blood vessel occluding device is delivered to the blood vessel puncture port 62 through the subcutaneous tissue 60 by means of a surgical instrument, the intracavitary anchor 40 is located on the inner side of the blood vessel wall 61, and the sponge plug 30 is located on the outer side of the blood vessel wall 61; after being delivered to the right place, the hand-held locking advancement tube 50 pushes the slipknot 11 at the front end of the lock buckle 20 toward the puncture port 62, so that the suture 10 connecting the intracavitary anchor 40 and the sponge plug 30 is tightened, so that the intracavitary anchor 40 fits against the inner side of the blood vessel wall 61, and the sponge plug 30 fits against the outer side of the blood vessel wall 61, and the puncture port 62 is closed from the outside of the blood vessel in the manner of intracavitary anchor 40-blood vessel wall 61-sponge plug 30. Fig.14 As shown, after the operation is completed, the locking push tube 50 is removed, the skin at the puncture port 62 is pressed downward, and the suture 10 is cut below the skin. Fig.15 As shown, after the occlusion is completed, the remaining implanted part is in the human body.

[0101] The above description is only a preferred embodiment of the present invention, and does not limit the patent scope of the present invention. All equivalent structural changes made by using the contents of the present invention specification and drawings under the inventive concept of the present invention, or directly / indirectly applied in other related technical fields are included in the patent protection scope of the present invention.

Claims

1. An intracavitary anchor, used in a vascular occlusion device, characterized in that: The intracavitary anchor comprises an anchor body and a drug-loaded coating coated on the surface of the anchor body, wherein the drug-loaded coating comprises at least one of an antiplatelet adhesion drug, an anticoagulant drug, an antiproliferative drug and an anti-infective drug.

2. The intracavitary anchor according to claim 1, characterized in that: The density of the drug in the drug-loaded coating is 0.1-10 μg / mm 2 and / or, The thickness of the drug-loaded coating is 10-20 μm.

3. The intracavitary anchor according to claim 1 or 2, characterized in that: The anchor body is made of absorbable polymer material or absorbable metal material; and / or, The wall thickness of the anchor body is 0.1-0.15 mm.

4. A method for preparing an intracavitary anchor as claimed in any one of claims 1 to 3, characterized in that: The preparation method comprises the following steps: preparing an anchor body; A drug solution is prepared and coated on the surface of the anchor body to form a drug-loaded coating, thereby obtaining the intracavitary anchor.

5. The method for preparing the intracavitary anchor according to claim 4, characterized in that: The steps of preparing the drug solution include: The drug, dopamine, oxidant, buffer and solvent are weighed according to the proportion, stirred and mixed to obtain a drug solution, wherein the concentration of the drug is 0.5-5wt%, the concentration of the dopamine is 1-10mg / L, the concentration of the buffer is 0.5-1.5mol / L; and the concentration of the oxidant is 1-1.5mg / L.

6. The method for preparing the intracavitary anchor according to claim 5, characterized in that: The buffer comprises at least one of tris(hydroxymethyl)aminomethane, bicarbonate and phosphate; and / or, The oxidant comprises at least one of (NH4)2S2O8, NaIO4, CuSO4, H2O2, KMnO4; and / or, The stirring and mixing temperature is 20-37°C, and the stirring and mixing time is 2-8h.

7. The method for preparing the intracavitary anchor according to claim 4, characterized in that: The step of coating the drug solution on the surface of the anchor body to form a drug-loaded coating comprises: The drug solution is coated on the surface of the anchor body by immersion, transfer, spraying or spin coating; The anchor body with the drug-loaded coating is immersed in a solution containing a reducing agent and an initiator, the pH value of the solution is adjusted, an oscillation reaction is performed, and then ultraviolet light curing, cleaning and drying are performed in sequence to obtain the intracavitary anchor.

8. The method for preparing the intracavitary anchor according to claim 7, characterized in that: The reducing agent is sodium cyanoborocyanide, and the concentration of the reducing agent is 0.1-2.5 wt %; and / or, The pH value is 4.5-6; and / or, The temperature of the oscillation reaction is 20-40° C., the time of the oscillation reaction is 2-6 hours, and the time of the UV curing is 1-60 minutes; and / or, The photoinitiator includes one or more of ruthenium pyridine complex, eosin Y, camphorquinone, and lithium phenyl-2,4,6-trimethylbenzoylphosphinate, and the content of the photoinitiator is 0.1-0.5 wt % of the mass of the dopamine.

9. The method for preparing an intracavitary anchor according to any one of claims 4 to 8, characterized in that: Before the step of coating the drug solution on the surface of the anchor body to form a drug-loaded coating, the method further comprises: The anchor body is surface treated to form a rough surface.

10. A blood vessel occlusion device, characterized in that: The vascular occlusion device comprises the intracavitary anchor as claimed in any one of claims 1 to 3, or comprises the intracavitary anchor prepared by the method for preparing an intracavitary anchor as claimed in any one of claims 4 to 9.

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