Plugging device

Abstract

A plugging device comprises a plugging piece and a covering piece, the plugging piece comprises a first net body and a first collecting element, and the near end of the first net body is collected in the first collecting element; the covering part comprises a second net body, a second collecting element and a third collecting element, the far end of the second net body is collected in the second collecting element, and the near end of the second net body is collected in the third collecting element. Wherein the first collecting element is suitable for being in butt joint with the second collecting element, and medical staff can select to independently use the plugging piece or select the proper plugging piece and the covering piece to be used in a matched mode according to the shape of the left auricle of a patient. Besides, a limiting structure is arranged at the connecting position of the first collecting element and the second collecting element, the first collecting element and the second collecting element can be prevented from being separated, and therefore the risk of connection failure of the plugging piece and the covering piece is eliminated in the conveying or implanting process of the plugging device or after the plugging device is implanted, and the operation quality safety is improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an occluder. Background Art

[0002] Thromboembolism caused by atrial fibrillation is caused by the detachment of thrombi formed in the left atrium. Previous studies have found that more than 90% of left atrial thrombi are located in the left atrial appendage. Through technologies including left atrial appendage occlusion, the left atrial appendage can be isolated from the systemic circulation, preventing most thromboembolic events caused by thrombosis and detachment from the source.

[0003] Transcatheter left atrial appendage occlusion is to deliver the catheter into the left atrium through an interventional delivery system, so that the distal end of the catheter is located near the left atrial appendage opening, and then the left atrial appendage occluder is delivered along the catheter lumen to the implantation position in the left atrial appendage, with the distal end of the occluder located in the left atrial appendage and the proximal end of the occluder located near the junction of the left atrial appendage and the left atrium to block the blood flow between the two. In current clinical experience, based on CT reconstruction or atrial appendage angiography, no left atrial appendage with consistent anatomical morphology has been found, that is, the anatomical structure of the left atrial appendage has obvious individual differences. In order to effectively adapt to more anatomical left atrial appendages so that more patients can obtain better occlusion effects, the customizability of the left atrial appendage occluder must be continuously improved. Utility Model Content

[0004] The purpose of the present application is to provide an occluder that can be customized for left atrial appendages of different forms, has a wider range of applications and better occlusion effects, and can cope with different occlusion strategies.

[0005] The technical solutions provided by this application are as follows:

[0006] An occluder, comprising:

[0007] Closing parts and covering parts;

[0008] The blocking member includes a first mesh and a first convergent element, wherein the proximal end of the first mesh is converged in the first convergent element; and the covering member includes a second mesh, a second convergent element and a third convergent element, wherein the distal end of the second mesh is converged in the second convergent element, and the proximal end of the second mesh is converged in the third convergent element;

[0009] The first bundling element is suitable for docking with the second bundling element, and at least two limiting structures are provided at the connection between the first bundling element and the second bundling element for limiting the separation of the first bundling element and the second bundling element.

[0010] In some embodiments, the first converging element is provided with one of a screw or a threaded hole, and the second converging element is provided with the other of a screw or a threaded hole;

[0011] The limiting structure has limiting surfaces and guiding surfaces on both sides of the screw in the circumferential direction, and a limiting space is formed between two adjacent limiting structures; the first mesh body and the second mesh body are both woven from a plurality of braided wires, and the braided wires on the first mesh body or the braided wires on the second mesh body can be selectively clamped in the limiting space;

[0012] When the screw is tightened in the threaded hole, the guide surface guides the braided wire to disengage from the original limiting space and enter the adjacent limiting space; when the screw tends to screw out of the threaded hole, the limiting surface restricts the braided wire from disengaging from the limiting space, thereby restricting the screw from disengaging from the threaded hole.

[0013] In some embodiments, the limiting structure is disposed at a distal end of the second focusing element.

[0014] In some embodiments, the second converging element includes a first inner layer member and a first annular member sleeved on the first inner layer member, and a clamping space for converging the distal end of the second mesh body is formed between the first inner layer member and the first annular member;

[0015] The limiting structure is arranged on the distal end surface of the first annular member, and the inner diameter of the first annular member is not less than the outer diameter of the first focusing element;

[0016] When the first bundling element is connected to the second bundling element, the distal end of the limiting structure penetrates into the first mesh body, and the braided wire portion at the proximal end of the first mesh body is limited within the limiting space.

[0017] In some embodiments, the limiting surface and the guiding surface are both arranged on the side of the distal end of the limiting structure close to the outer wall of the first annular component; or, the limiting surface and the guiding surface are both arranged on the side of the distal end of the limiting structure close to the inner wall of the first annular component.

[0018] In some embodiments, the screw is disposed at the distal end of the first inner layer component, and the threaded hole is disposed at the proximal end of the first focusing element.

[0019] In some embodiments, a first engaging surface is provided at a proximal end of the first bundling element, and a second engaging surface is provided at a proximal end of the second bundling element; when the first bundling element is in contact with the second bundling element, the first engaging surface and the second engaging surface are in conflict with each other.

[0020] In some embodiments, the distal end of the first inner layer member is located at a portion of the circumference of the screw to form the second joint surface;

[0021] or

[0022] The second converging element also includes a second annular member, which is sleeved on the screw and located inside the first annular member; a circular structure is formed at the proximal end of the first inner layer member, the proximal end of the second annular member abuts against the distal end of the circular structure, and the distal end of the second annular member forms the second joint surface; wherein a clamping space for converging the distal end of the second mesh body is formed between the second annular member and the first annular member.

[0023] In some embodiments, the proximal end of the first inner layer is annular in structure, and a third annular member is disposed inside the proximal end of the first inner layer, the third annular member forms a receiving space at the proximal end of the first inner layer for receiving the distal end of the second mesh, and a clamping space for converging the distal end of the second mesh is formed between the first inner layer and the third annular member;

[0024] or

[0025] The proximal end of the circular structure is provided with an annular structure, and the annular structure forms a accommodating space for accommodating the distal end of the second mesh body at the proximal end of the first inner layer component.

[0026] In some embodiments, there is an arc transition between two adjacent limiting structures.

[0027] In some embodiments, the limiting surface is a planar structure extending along the length direction of the screw, or the limiting surface is a concave arc surface structure; and

[0028] The guiding surface is in a sloped structure, or the guiding surface is in a concave arc structure, or the guiding surface is in a convex arc structure.

[0029] In some embodiments, the limiting structure further includes an end surface, and the end surface is used to connect the limiting surface and the guiding surface.

[0030] In some embodiments, the blocking member further includes a fourth convergent element, the distal end of the first mesh body is converged to the proximal end of the fourth convergent element, and the distal end of the fourth convergent element does not protrude from the first mesh body, so as to form a concave spherical surface or a concave conical surface at the distal end of the blocking member;

[0031] The proximal end of the first mesh body is converged to the distal end of the first convergence element, and the proximal end of the first convergence element does not protrude from the first mesh body, so as to form a concave tapered surface at the proximal end of the blocking member;

[0032] The distal end of the second mesh body is converged at the proximal end of the second converging element, and the distal end of the second converging element protrudes from the second mesh body to form an outwardly convex conical surface at the distal end of the cover.

[0033] In some embodiments, a radial dimension of the blocking member is smaller than a radial dimension of the covering member.

[0034] The technical effects of this application are:

[0035] The occluder in the present application includes two parts, a closure member and a cover member, and the closure member and the cover member can be connected and matched through the first focusing element and the second focusing element. In actual use, medical staff can choose to use the closure member alone or select suitable closure members and cover members for use in combination according to the morphology of the patient's left atrial appendage, which greatly increases the scope of application of the occluder, has high flexibility, and can cope with different occlusion strategies. Moreover, the occluder selected (or assembled) based on the morphology of the patient's left atrial appendage can better fit the morphology of the patient's left atrial appendage and have a better occlusion effect. In addition, the occluder in the present application is provided with a limiting structure at the connection between the first focusing element and the second focusing element, which can limit the separation of the first focusing element and the second focusing element, thereby eliminating the risk of failure of the connection between the closure member and the cover member during the transportation and implantation of the occluder or after implantation, thereby improving the quality and safety of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The present application is further described in detail below with reference to the accompanying drawings and specific implementation methods:

[0037] Figure 1 It is a schematic diagram of a treatment application scenario used in an embodiment of the present application;

[0038] Figure 2 It is a schematic diagram of the structure of several common left atrial appendages provided in the embodiments of the present application;

[0039] Figure 3 is a schematic diagram of the structure of the occluder provided in an embodiment of the present application;

[0040] Figure 4 yes Figure 3 A local enlarged schematic diagram of point A is shown;

[0041] Figure 5 It is a structural schematic diagram of a blocking member provided in an embodiment of the present application;

[0042] Figure 6 is a schematic structural diagram of another blocking member provided in an embodiment of the present application;

[0043] Figure 7 is a schematic diagram of the structure of the cover provided in the embodiment of the present application;

[0044] Figure 8 is a schematic diagram of the three-dimensional structure of the first bundling element provided in an embodiment of the present application;

[0045] Fig. 9is a schematic diagram of a first bundling element provided in an embodiment of the present application;

[0046] Fig.10 is a schematic diagram of another first bundling element provided in an embodiment of the present application;

[0047] Fig.11 is a schematic structural diagram of a second bundling element provided in an embodiment of the present application;

[0048] Fig.12 It is a structural schematic diagram of a limiting structure provided in an embodiment of the present application;

[0049] Fig.13 is a structural schematic diagram of another limiting structure provided in an embodiment of the present application;

[0050] Fig.14 is a schematic structural diagram of another second bundling element provided in an embodiment of the present application;

[0051] Fig.15 yes Fig.14 A cross-sectional view in the direction BB is shown;

[0052] Fig.16 is a structural schematic diagram of another second bundling element provided in an embodiment of the present application;

[0053] Fig.17 yes Fig.16 A cross-sectional view in the CC direction is shown;

[0054] Fig.18 is a schematic structural diagram of a first annular member provided in an embodiment of the present application;

[0055] Fig.19 is a schematic structural diagram of another first annular member provided in an embodiment of the present application;

[0056] Fig. 20 This is a schematic diagram of the structure of another first annular member provided in an embodiment of the present application.

[0057] Description of Figure Numbers:

[0058] 100, blocking member; 110, first mesh body; 111, anchoring structure; 120, first convergence element; 121, second inner layer member; 1211, threaded hole; 122, fourth annular member; 123, first joint surface; 130, fourth convergence element;

[0059] 200, covering member; 210, second mesh body; 220, second convergence element; 221, first inner layer member; 2211, screw; 2212, annular structure; 2213, circular structure; 222, first annular member; 223, second annular member; 224, third annular member; 225, accommodating space; 226, second joint surface; 230, third convergence element;

[0060] 300, limiting structure; 310, limiting surface; 320, guiding surface; 330, end surface;

[0061] 410, limited space; 420, far space;

[0062] 501. Aorta; 502. Aortic valve; 503. Left ventricle; 504. Left atrium; 505. Mitral valve; 506. Left atrial appendage; 507. Right ventricle; 508. Right atrium; 509. Tricuspid valve; 510. Atrial septum; 511. Superior vena cava; 512. Inferior vena cava. DETAILED DESCRIPTION

[0063] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the specific implementation methods of the present application will be described below with reference to the accompanying drawings. The accompanying drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other accompanying drawings and other implementation methods can be obtained based on these drawings without creative work. Adjustments and improvements made without departing from the concept of the present application are all within the scope of protection of the present application.

[0064] In order to simplify the drawings, the drawings in the embodiments of the present application only schematically show the parts related to the present application, and they do not represent the actual structure of the product. In addition, in order to simplify the drawings and facilitate understanding, in some drawings, only parts with the same structure or function are schematically shown, and there may be more or fewer parts with the same structure or function in reality.

[0065] In this application, unless otherwise clearly specified and limited, ordinal numbers, such as "first", "second", etc., are only used to distinguish and describe related objects, and cannot be understood as indicating or implying the relative importance or order between related objects; in addition, they do not represent the number of related objects. "And / or" is used to describe the relationship between related objects, which includes any relationship between related objects. For example, "a and / or b" includes: "a alone", "b alone", or "a and b". The terms "installation" and "connection" should be understood in a broad sense. For example, "installation" can be direct installation or installation through other components; "connection" can be direct connection or connection through other components. The term "relatively arranged" includes parallel relative or relative at a certain angle. The angle is not limited and is determined according to the number of relatively arranged objects.

[0066] In the embodiments shown in the drawings, directional indications (such as up, down, left, right, front, and back, etc.) are not absolute but relative when describing the structure and movement of each component, and are not used to limit the direction of the product in actual use.

[0067] In the embodiments of the present application, "proximal end" refers to the end of the associated object close to the operator; "distal end" refers to the end of the associated object far from the operator. "Proximal end" and "distal end" refer to the position or direction of the associated object (e.g., a component of a medical device) relative to the operator from the perspective of an operator (e.g., a doctor) using the device (e.g., a medical device) where the associated object is located. For example, "proximal end" refers to the end close to the doctor during the doctor's normal operation of the medical device, while "distal end" refers to the end far from the doctor during the doctor's normal operation of the medical device, that is, the end that first enters the patient's body.

[0068] In recent years, with the frequent occurrence of stroke patients, people are paying more and more attention to the problem of atrial fibrillation. Atrial fibrillation, also known as "atrial fibrillation", is a major disease that threatens public health. About 5% of atrial fibrillation patients suffer from stroke every year; among all stroke patients, about 20% are related to atrial fibrillation. Among them, studies have shown that more than 90% of left atrium thrombi come from the left atrial appendage.

[0069] See also Figure 1 The heart is a hollow muscular organ with four chambers, namely the left atrium 504, the left ventricle 503, the right atrium 508 and the right ventricle 507. The four chambers of the heart are connected to different blood vessels. The left ventricle 503 is connected to the aorta 501. The aorta 501 orifice is located above and right in front of the left atrioventricular orifice, and the semilunar aortic valve 502 is attached to the periphery. The left atrium 504 is connected to the pulmonary vein, the right ventricle 507 is connected to the pulmonary artery, and the right atrium 508 is connected to the superior vena cava 511 and the inferior vena cava 512. The left atrium 504 and the right atrium 508 are separated by an atrial septum 510. The part of the front of the left atrium 504 that protrudes to the right front is the left atrial appendage 506. The left ventricle 503 and the right ventricle 507 are separated by a ventricular septum. There is an atrioventricular valve (hereinafter referred to as valve) between the atrium and the ventricle. When the ventricle relaxes, the valve opens and blood flows from the atrium to the ventricle; when the ventricle contracts, the valve closes to prevent blood from flowing back from the ventricle to the atrium. The valve between the left atrium 504 and the left ventricle 503 is the mitral valve 505, and the valve between the right atrium 508 and the right ventricle 507 is the tricuspid valve 509.

[0070] Theoretically, through left atrial appendage occlusion surgery, an interventional surgical method is used to puncture the femoral vein, and the occluder is delivered through the femoral vein to the landing area in the left atrial appendage 506 and then deployed to block the left atrial appendage 506. This can prevent the blood clot formed in the left atrial appendage 506 from dislodging and forming an embolism, and can reduce the chance of atrial fibrillation embolism by at least 90%.

[0071] Generally, the landing area of ​​the occluder is closer to the adjacent area between the left atrium 504 and the left atrial appendage 506, which may be referred to as the orifice of the left atrial appendage 506. However, in current clinical experience, no consistent anatomical morphology of the left atrial appendage 506 has been found based on CT reconstruction or atrial appendage angiography, including but not limited to Figure 2 The anatomical morphology shown. The landing area and the morphology of the left atrial appendage 506 orifice of different morphologies of the left atrial appendage 506 are also different, so it is particularly important to develop a customizable occluder.

[0072] The following is a description with reference to the accompanying drawings:

[0073] See also Figure 3 and Figures 5 to 7 , which is a schematic diagram of the structure of an occluder provided in an embodiment of the present application, the occluder includes an occluder 100 and a cover 200. The occluder 100 includes a first mesh 110 and a first converging element 120, the first mesh 110 is woven from a plurality of elastic metal braided wires, and its proximal end is converging in the first converging element 120. Correspondingly, the cover 200 includes a second mesh 210, a second converging element 220 and a third converging element 230, the second mesh 210 is also woven from a plurality of elastic metal braided wires, and the distal end of the second mesh 210 is converging in the second converging element 220, and the proximal end of the second mesh 210 is converging in the third converging element 230. Among them, the first converging element 120 is suitable for docking with the second converging element 220 to connect the occluder 100 and the cover 200.

[0074] In this embodiment, the occluder includes two parts, the occluding member 100 and the covering member 200, and the occluding member 100 and the covering member 200 can be connected and matched through the first converging element 120 and the second converging element 220, so that the occluding member 100 can be used independently or in combination with the covering member 200. In this way, in actual use, medical staff can choose to use the occluding member 100 alone or select a suitable occluding member 100 and covering member 200 for combination use according to the morphology of the patient's left atrial appendage 506, which greatly increases the scope of application of the occluder and is highly flexible.

[0075] Specifically, in actual production, the occluding member 100 and the covering member 200 with different axial (distal to proximal) and radial (perpendicular to the axial) sizes can be produced. For the occluding member 100 with a larger axial size, it can be used alone, so that it is fully or partially implanted inside the left atrial appendage 506 to block the blood flow between the left atrial appendage 506 and the left atrium 504; for the occluding member 100 with a smaller axial size, it can be used together with the covering member 200, so that the occluding member 100 is fully implanted inside the left atrial appendage 506, and the covering member 200 covers the left atrial appendage 506 opening to block the blood flow between the left atrial appendage 506 and the left atrium 504.

[0076] The occluding parts 100 of different sizes and the covering parts 200 of different sizes can be matched with each other to form a variety of different combinations, so as to obtain occluders of more specifications, which have a wide range of applications and are more conducive to medical staff to obtain the most suitable occluder according to the patient's left atrial appendage 506 angiography to cope with different occluding strategies.

[0077] More importantly, if more forms of left atrial appendage 506 appear in the future, suitable occluding parts 100 and / or covering parts 200 can be further produced, which can be matched with the covering parts 200 and / or occluding parts 100 that have been produced, and more combinations can be further formed, thereby realizing the continuous development of the customizability of the occluding part 100 and having strong practicality.

[0078] The cover 200 used with the plugging member 100 is preferably a flat, arc-shaped structure with a certain thickness, and the radial dimension of the plugging member 100 is smaller than the radial dimension of the cover 200. By setting the radial dimension of the cover 200 to be larger than the radial dimension of the plugging member 100, the flow blocking effect of the plugger can be further enhanced, and the plugging effect is better.

[0079] In a specific embodiment, the blocking member 100 may further include a fourth converging element 130, and in this case, the distal end of the blocking member 100 is converging inside the fourth converging element 130. Of course, in actual production, the distal end of the blocking member 100 may not be converging, which is not limited here and is within the protection scope of the present application.

[0080] In one example embodiment, see Figure 4 At least two limiting structures 300 should be provided at the connection between the first bundling element 120 and the second bundling element 220 to limit the separation of the first bundling element 120 and the second bundling element 220, so as to eliminate the risk of connection failure between the occluding component 100 and the covering component 200 during the occluder delivery, implantation or after implantation, thereby improving the quality and safety of the operation.

[0081] Specifically, see Figure 8 , Figures 11 to 14 and Fig.16 The first bundling element 120 is provided with one of a screw 2211 or a threaded hole 1211, and the second bundling element 220 is provided with the other of a screw 2211 or a threaded hole 1211. The limiting structure 300 has limiting surfaces 310 and guide surfaces 320 on both sides of the screw 2211 in the circumferential direction, and a limiting space 410 is formed between two adjacent limiting structures 300, and the braided wires on the first mesh body 110 or the braided wires on the second mesh body 210 can be selectively clamped in the limiting space 410.

[0082] When the screw 2211 is tightened in the threaded hole 1211, the guide surface 320 can guide the braided wire to disengage from the original limiting space 410 and enter the adjacent limiting space 410; when the screw 2211 tends to screw out of the threaded hole 1211, the limiting surface 310 will limit the braided wire from disengaging from the limiting space 410, thereby limiting the screw 2211 from disengaging from the threaded hole 1211, thereby achieving the function of radial unidirectional limiting, preventing the sealing member 100 and the covering member 200 from accidentally falling off.

[0083] In this embodiment, the threaded cooperation between the screw 2211 and the threaded hole 1211 can also achieve a certain self-locking effect. Combined with the one-way limiting function of the limiting structure 300, it can further improve the connection strength between the first focusing element 120 and the second focusing element 220, and eliminate the risk of failure of the connection between the sealing member 100 and the covering member 200.

[0084] Specifically, the limiting surface 310 is provided on the side of the limiting structure 300 away from the screw 2211 and the tightening direction of the thread, and the limiting surface 310 is preferably a planar structure extending along the length direction of the screw 2211. Of course, in actual production, the limiting surface 310 can also be a planar structure inclined away from the screw 2211 and the tightening direction of the thread, and there is no limitation here, as long as the braided wire cannot escape from the limiting space 410 along the limiting surface 310. Relatively speaking, the guide surface 320 is provided on the side of the limiting structure 300 facing the tightening direction of the screw 2211 and the threaded hole 1211, and the limiting surface 310 is preferably a planar structure inclined away from the screw 2211 and the tightening direction of the thread.

[0085] Specifically, see Fig.12 The angle a between the limiting surface 310 of each limiting structure 300 and the guiding surface 320 of the adjacent limiting structure 300 is an acute angle, ranging from 30 to 90 degrees. Furthermore, the limiting surface 310 and the guiding surface 320 may also be arcuate structures. The arc length d of the limiting surface 310 may range from 0.2 to 1.8 mm, and the arc may range from 0 to 60 degrees; the arc length l of the guiding surface 320 may range from 1.5d to 15d, and the arc may range from 5 to 30 degrees.

[0086] In this way, the limiting space 410 between two adjacent limiting structures 300 can be sufficient to accommodate at least one braided wire to adapt to a variety of meshes woven by elastic metal braided wires of different specifications. It has a wide range of applications and is more conducive to the random combination and matching of sealing parts 100 of different specifications and covering parts 200 of different specifications.

[0087] As a preference, see Fig.13, the arc transition between two adjacent limiting structures 300 can make it easier for the limiting space 410 to accommodate the braided wire and make better use of the space. It should be noted that the braided wire to be accommodated should not protrude from the open end of the limiting space 410, that is, it should not protrude from the end of the guide surface 320 and the limiting surface 310, so as to strengthen the unidirectional limiting effect of the limiting structure 300 on the braided wire.

[0088] On this basis, the guide surface 320 and the limiting surface 310 can be set to be a concave arc structure. While ensuring the limiting effect of the limiting structure 300 on the braided wire, the size of the limiting space 410 is further expanded to make it easier to accommodate the braided wire, and the arc length d of the limiting surface 310 can also be shorter, so that the space is fully utilized, and a shorter second focusing element 220 can be used to achieve the connection and unidirectional limiting effect.

[0089] Of course, in actual production, only the guide surface 320 is a concave arc structure or only the position surface 310 is a concave arc structure, which can expand the size of the limiting space 410 to a certain extent. No limitation is made here and it is within the protection scope of this application.

[0090] For example, the guide surface 320 can also be set to be an outwardly convex arc surface, which is more conducive to guiding the braided wire to disengage from the original limiting space 410 during the tightening process of the screw 2211 and the threaded hole 1211, making the assembly of the first bundling element 120 and the second bundling element 220 more convenient and quick.

[0091] In actual production, see Figures 18 to 20 The limiting surface 310 and the guiding surface 320 can be directly connected by a common edge. In this case, the limiting structure 300 is in a sharp tooth structure. In order to reduce the wear of the braided wire by the tip of the limiting structure 300 during the tightening process of the screw 2211, a circular arc transition can be used between the limiting surface 310 and the guiding surface 320.

[0092] In addition, see Fig.12 and Fig.13 , an end surface 330 may also be provided on the limiting structure 300, and the limiting surface 310 and the guide surface 320 may be connected by the end surface 330. In an exemplary embodiment, the end surface 330 may be an arc surface structure, and the arc length w of the end surface 330 may be in the range of 0-0.8 mm, and the arc may be 0-30°.

[0093] Specifically, see Fig.11 , 14 and Fig.16The limiting structure 300 can be arranged at the proximal end of the first converging element 120. When the first converging element 120 and the second converging element 220 are connected, the limiting structure 300 can penetrate into the second mesh 210 to limit part of the braided wires at the distal end of the second mesh 210 within the limiting space 410. Due to the converging of the second converging element 220, the distal end of the second mesh 210 is closely arranged, and the force between the braided wires and the limiting structure 300 is sufficient to overcome the separation tendency between the first converging element 120 and the second converging element 220, thereby limiting the separation of the blocking member 100 and the covering member 200. Conversely, the limiting structure 300 can also be arranged at the distal end of the second converging element 220. When the first converging element 120 and the second converging element 220 are connected, the limiting structure 300 can penetrate into the first mesh 110 to limit part of the braided wires at the proximal end of the first mesh 110 within the limiting space 410. Similarly, the proximal end of the first mesh body 110 is closely arranged due to the contraction of the first contracting element 120, and the force between the braided wire and the limiting structure 300 is sufficient to overcome the separation tendency between the first contracting element 120 and the second contracting element 220, thereby limiting the separation of the blocking member 100 and the covering member 200.

[0094] In one example embodiment, see Fig. 9 and Fig.10 The second converging element 220 includes a first inner layer component 221 and a first annular component 222 sleeved on the first inner layer component 221 , and a clamping space for converging the distal end of the second mesh body 210 is formed between the first inner layer component 221 and the first annular component 222 .

[0095] Correspondingly, the first bundling element 120 may include a second inner layer member 121 and a fourth annular member 122 sleeved on the second inner layer member 121 , and a clamping space for bundling the proximal end of the first mesh body 110 is formed between the second inner layer member 121 and the fourth annular member 122 .

[0096] If the limiting structure 300 is set at the proximal end of the first converging element 120, then the inner diameter of the fourth ring member 122 should not be less than the outer diameter of the first ring member 222, and the fourth ring member 122 and the second inner member 121 form a proximal space at the proximal end of the first converging element 120, so that the second converging element 220 can be fully or partially inserted into the fourth ring member 122 and located in the proximal space. At this time, the limiting structure 300 can be set on the distal end face 330 of the fourth ring member 122, or on the distal inner wall of the fourth ring member 122. When the limiting structure 300 is set on the inner wall of the fourth ring member 122, it should be noted that the first converging element 120 should be avoided to prevent interference between parts.

[0097] In contrast, if the limiting structure 300 is disposed at the proximal end of the second convergence element 220, the inner diameter of the first annular component 222 should not be less than the outer diameter of the fourth annular component 122, and the first annular component 222 and the first inner layer component 221 form a distal space 420 at the distal end of the second convergence element 220, so that the first convergence element 120 can be fully or partially inserted into the first annular component 222 and located in the distal space 420. In this case, the limiting structure 300 can be disposed on the distal end surface 330 of the first annular component 222 or on the distal inner wall of the first annular component 222. When the limiting structure 300 is disposed on the inner wall of the fourth annular component 122, care should be taken to avoid the first convergence element 120 to prevent interference between parts.

[0098] It is worth noting that among the four limiting structure 300 setting schemes mentioned in this embodiment, the scheme of setting the limiting structure 300 on the distal end surface 330 of the first annular member 222 is the best. Because, during the occluder delivery and implantation process, the braided wire at the proximal end of the first mesh body 110 is more easily brought into the bottom of the limiting space 410 (the proximal end of the limiting space 410), making it more difficult for the braided wire to escape from the limiting space 410, thereby better eliminating the risk of failure of the connection between the occluding member 100 and the covering member 200, and improving the quality and safety of the operation.

[0099] The number of the limiting structures 300 disposed on the distal end surface 330 of the first annular member 222 is preferably 2-12, and the limiting structures 300 on the first annular member 222 are evenly spaced along the circumference of the first annular member 222 .

[0100] Furthermore, the first bundling element 120 has a first bonding surface 123 at its proximal end, and the second bundling element 220 has a second bonding surface 226. When the first bundling element 120 and the second bundling element 220 are in contact with each other, the first bonding surface 123 and the second bonding surface 226 are in conflict with each other.

[0101] This embodiment can improve the degree of fit between the first and second focusing elements 120 and 220 when they are docked by providing a first engaging surface 123 and a second engaging surface 226 that can engage with each other. At the same time, a friction force for limiting the relative rotation of the first and second focusing elements 120 and 220 can be generated between the first and second engaging surfaces 123 and 226, thereby further limiting the separation of the first and second focusing elements 120 and 220, reducing the risk of accidental separation of the sealing member 100 and the covering member 200, and improving the quality and safety of the operation.

[0102] Taking the example that the screw 2211 is disposed at the distal end of the first inner layer component 221 and the threaded hole 1211 is disposed at the proximal end of the second inner layer component 121 , the specific structures of the first focusing element 120 and the second focusing element 220 are described.

[0103] Specifically, see Figures 8 to 10 The proximal end surface 330 of the fourth annular member 122 and the proximal end surface 330 of the second inner layer member 121 are flush with each other, and together form a first joint surface 123 on the first bundling element 120 .

[0104] In this embodiment, the proximal end of the first net body 110 can extend from the distal end of the first converging element 120 into the clamping space between the fourth annular member 122 and the second inner layer member 121, so as to be converging by the fourth annular member 122 and the second inner layer member 121. Alternatively, the proximal end of the first net body 110 can also extend from the proximal end of the first converging element 120 into the clamping space between the fourth annular member 122 and the second inner layer member 121, so as to be converging by the fourth annular member 122 and the second inner layer member 121, which is not limited here and is within the protection scope of this application.

[0105] In one example embodiment, see Fig.15 The distal end of the first inner layer 221 is located at the peripheral side of the screw 2211 to form the second joint surface 226. At this time, the distal end of the second mesh body 210 can extend from the proximal end of the second converging element 220 into the clamping space between the first annular member 222 and the first inner layer 221, so as to be converging by the first annular member 222 and the first inner layer 221.

[0106] Further, see Fig.15 The proximal end of the first inner layer 221 is in the form of an annular structure 2212, and a third annular member 224 is disposed inside the proximal end of the first inner layer 221. At this time, a clamping space is formed between the first inner layer 221 and the third annular member 224 that can be used to converge the distal end of the second mesh body 210.

[0107] In this embodiment, the distal end of the second net body 210 can be gathered between the first annular member 222 and the first inner layer member 221, and can also be gathered between the third annular member 224 and the first inner layer member 221. The third annular member 224 is formed with a receiving space 225 at the proximal end of the first inner layer member 221, which can accommodate the distal end of the second net body 210. The distal end of the second net body 210 can penetrate into the receiving space 225 from the proximal end of the third annular member 224, and pass out from the distal end of the third annular member 224 to be sandwiched between the third annular member 224 and the first inner layer member 221. Alternatively, the distal end of the second net body 210 penetrates into the receiving space 225 from the distal end of the third annular member 224, and passes out from the proximal end of the third annular member 224, and then the third annular member 224 is placed in the annular structure 2212, and the distal end of the second net body 210 can also be sandwiched between the third annular member 224 and the first inner layer member 221. Of course, the distal end of the second mesh body 210 may also be converged by another convergence element and passed through the accommodating space 225, which will not be elaborated one by one, and are all within the protection scope of the present application.

[0108] In this embodiment, the third annular member 224, the first inner layer member 221 and the first annular member 222 are arranged in sequence from the inside to the outside and are connected by interference fit, welding or bonding.

[0109] In actual production, the annular structure 2212 may not be set at the proximal end of the first inner layer 221, that is, the proximal end of the second converging element 220 does not include the accommodating space 225. At this time, the distal end of the second mesh body 210 can also be converging between the first annular member 222 and the first inner layer 221, or can be converging between the third annular member 224 and the first inner layer 221.

[0110] In one example embodiment, see Fig.17 The second converging element 220 also includes a second annular member 223, which is sleeved on the screw 2211 and located inside the first annular member 222. A circular structure 2213 is formed at the proximal end of the first inner layer 221. At this time, the proximal end of the second annular member 223 abuts against the distal end of the circular structure 2213, and the distal end of the second annular member 223 forms the above-mentioned second joint surface 226. At the same time, a clamping space that can be used to converge the distal end of the second net body 210 can be formed between the second annular member 223 and the first annular member 222, and the distal end of the second net body 210 can be converged between the first annular member 222 and the second annular member 223, or connected to the circular structure 2213 after being converged by another converging element.

[0111] Specifically, an annular structure 2212 can be provided at the proximal end of the circular structure 2213, and the annular structure 2212 can form a receiving space 225 at the proximal end of the first inner layer 221 to receive the distal end of the second mesh 210. In this way, the distal end of the second mesh 210 can be gathered by the gathering element, passed through the receiving space 225 and connected to the circular structure 2213.

[0112] In a specific embodiment, see Figure 3 , Figure 5 and Figure 6 The distal end of the first mesh body 110 is converged at the proximal end of the fourth converging element 130 , and the distal end of the fourth converging element 130 does not protrude from the first mesh body 110 , so as to form a concave spherical surface or a concave conical surface at the distal end of the blocking member 100 .

[0113] If the proximal end of the first net body 110 extends from the proximal end of the first converging element 120 into the clamping space between the fourth ring-shaped part 122 and the second inner layer part 121, and is thereby converging by the fourth ring-shaped part 122 and the second inner layer part 121, then the limiting surface 310 and the guiding surface 320 are preferably arranged on the side of the distal end of the limiting structure 300 close to the outer wall of the first ring-shaped part 222; if the proximal end of the first net body 110 extends from the proximal end of the first converging element 120 into the clamping space between the fourth ring-shaped part 122 and the second inner layer part 121, and is thereby converging by the fourth ring-shaped part 122 and the second inner layer part 121, then the limiting surface 310 and the guiding surface 320 are preferably arranged on the side of the distal end of the limiting structure 300 close to the inner wall of the first ring-shaped part 222.

[0114] In contrast, the proximal end of the first mesh body 110 is converged to the distal end of the first converging element 120 , and the proximal end of the first converging element 120 does not protrude from the first mesh body 110 , so as to form a concave conical surface at the proximal end of the blocking member 100 .

[0115] In this embodiment, the concave structure (concave spherical surface or concave conical surface) formed by the first mesh body 110 at the distal end of the blocking piece 100, as well as the concave structure (concave conical surface) formed by the first mesh body 110 at the proximal end of the blocking piece 100, can provide strong radial supporting force for the blocking piece 100, so that the blocking piece 100 can be used alone.

[0116] Further, see Figure 7 The distal end of the second mesh body 210 is converged at the proximal end of the second converging element 220 , and the distal end of the second converging element 220 protrudes from the second mesh body 210 to form a convex conical surface at the distal end of the cover 200 .

[0117] In one example embodiment, see Figure 3 , Figure 5 and Figure 6 The occluding member 100 is also provided with an anchoring structure 111 , which is located on a portion of the elastic metal braided wire on the first mesh body 110 so as to fix the occluding member 100 at the left atrial appendage 506 .

[0118] Specifically, the first mesh body 110 has an outward surface that is "exposed" or may be "exposed" to human tissue, and an inward surface opposite to the outward surface, and the inward surface faces the interior of the first mesh body 110; the anchoring structure 111 is distributed on the outward surface of the first mesh body 110.

[0119] In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described or recorded in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0120] It should be noted that the above embodiments can be freely combined as needed. The above are only preferred implementations of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application, and these improvements and modifications should also be regarded as the protection scope of the present application.

Claims

1. An occluder, characterized in that: include: Closing parts and covering parts; The blocking member includes a first mesh body and a first converging element, wherein the proximal end of the first mesh body is converging in the first converging element; And, the covering member includes a second mesh, a second converging element and a third converging element, the distal end of the second mesh is converging in the second converging element, and the proximal end of the second mesh is converging in the third converging element; The first bundling element is suitable for docking with the second bundling element, and at least two limiting structures are provided at the connection between the first bundling element and the second bundling element for limiting the separation of the first bundling element and the second bundling element.

2. The occluder according to claim 1, characterized in that: The first bundling element is provided with one of a screw or a threaded hole, and the second bundling element is provided with the other of a screw or a threaded hole; The limiting structure has limiting surfaces and guiding surfaces on both sides of the screw in the circumferential direction, and a limiting space is formed between two adjacent limiting structures; the first mesh body and the second mesh body are both woven from a plurality of braided wires, and the braided wires on the first mesh body or the braided wires on the second mesh body can be selectively clamped in the limiting space; When the screw is tightened in the threaded hole, the guide surface guides the braided wire to disengage from the original limiting space and enter the adjacent limiting space; when the screw tends to screw out of the threaded hole, the limiting surface restricts the braided wire from disengaging from the limiting space, thereby restricting the screw from disengaging from the threaded hole.

3. The occluder according to claim 2, characterized in that: The limiting structure is arranged at the distal end of the second focusing element.

4. The occluder according to claim 3, characterized in that: The second converging element comprises a first inner layer member and a first annular member sleeved on the first inner layer member, and a clamping space for converging the distal end of the second mesh body is formed between the first inner layer member and the first annular member; The limiting structure is arranged on the distal end surface of the first annular member, and the inner diameter of the first annular member is not less than the outer diameter of the first focusing element; When the first bundling element is connected to the second bundling element, the distal end of the limiting structure penetrates into the first mesh body, and the braided wire portion at the proximal end of the first mesh body is limited within the limiting space.

5. The occluder according to claim 4, characterized in that: The limiting surface and the guiding surface are both arranged on a side of the distal end of the limiting structure close to the outer wall of the first annular component; or, the limiting surface and the guiding surface are both arranged on a side of the distal end of the limiting structure close to the inner wall of the first annular component.

6. The occluder according to claim 4, characterized in that: The screw is arranged at the distal end of the first inner layer component, and the threaded hole is arranged at the proximal end of the first focusing element.

7. The occluder according to claim 6, characterized in that: The first bundling element has a first joint surface at its proximal end, and the second bundling element has a second joint surface. When the first bundling element is in contact with the second bundling element, the first joint surface and the second joint surface are in conflict with each other.

8. The occluder according to claim 7, characterized in that: The distal end of the first inner layer member is located at the peripheral side of the screw to form the second joint surface; or The second converging element also includes a second annular member, which is sleeved on the screw and located inside the first annular member; a circular structure is formed at the proximal end of the first inner layer member, the proximal end of the second annular member abuts against the distal end of the circular structure, and the distal end of the second annular member forms the second joint surface; wherein a clamping space for converging the distal end of the second mesh body is formed between the second annular member and the first annular member.

9. The occluder according to claim 8, characterized in that: The proximal end of the first inner layer member is annular in structure, and a third annular member is disposed inside the proximal end of the first inner layer member, the third annular member forms a receiving space at the proximal end of the first inner layer member for receiving the distal end of the second net body, and a clamping space for converging the distal end of the second net body is formed between the first inner layer member and the third annular member; or The proximal end of the circular structure is provided with an annular structure, and the annular structure forms a accommodating space for accommodating the distal end of the second mesh body at the proximal end of the first inner layer component.

10. The occluder according to any one of claims 2 to 9, characterized in that: There is an arc transition between two adjacent limiting structures.

11. The occluder according to any one of claims 2 to 9, characterized in that: The limiting surface is a planar structure extending along the length direction of the screw rod, or the limiting surface is a concave arc surface structure; and The guiding surface is in a sloped structure, or the guiding surface is in a concave arc structure, or the guiding surface is in a convex arc structure.

12. The occluder according to any one of claims 2 to 9, characterized in that: The limiting structure further includes an end surface, and the end surface is used to connect the limiting surface and the guiding surface.

13. The occluder according to any one of claims 1 to 9, characterized in that: The blocking member further includes a fourth convergent element, the distal end of the first mesh body is converged at the proximal end of the fourth convergent element, and the distal end of the fourth convergent element does not protrude from the first mesh body, so as to form a concave spherical surface or a concave conical surface at the distal end of the blocking member; The proximal end of the first mesh body is converged to the distal end of the first convergence element, and the proximal end of the first convergence element does not protrude from the first mesh body, so as to form a concave tapered surface at the proximal end of the blocking member; The distal end of the second mesh body is converged at the proximal end of the second converging element, and the distal end of the second converging element protrudes from the second mesh body to form an outwardly convex conical surface at the distal end of the cover.

14. The occluder according to any one of claims 1 to 9, characterized in that: The radial dimension of the blocking member is smaller than the radial dimension of the covering member.

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