Foam plug for left atrial appendage

Abstract

The application relates to the technical field of ear canal occluder, and discloses a left atrial appendage foam occluder which comprises an occlusion support and a porous polyurethane foam film, the occlusion support comprises a support body and a mouth opening tail part which is arranged on the support body; the mouth opening tail part comprises a plurality of uplift connecting rods which are arranged in a circumferential array; a plurality of barbs and a plurality of adaptive rods are arranged on the support body; a plurality of the uplift connecting rods fold the tissue between the porous polyurethane foam films on the outer surface of the support body, and tissue inlay is formed in the occlusion support. The adaptive rods are arranged, the mouth opening tail part of the occlusion support can provide axial freedom, can adapt to various irregular left atrial appendage inner wall shapes, the occluder is prevented from being subjected to uneven axial force, the circumferential occlusion performance is more uniform, and the occurrence of blood leakage is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of ear canal occluder, and particularly relates to a left atrial appendage foam occluder. BACKGROUND

[0002] Atrial fibrillation is a common rapid arrhythmia, and 1% of people over 60 years old have atrial fibrillation, and the incidence doubles with age, of which 3%-11% are patients without organic heart disease, and atrial fibrillation can cause blood clots in the heart, which will increase the risk of stroke, heart failure and other complications related to the heart, and 90% of non-valvular heart atrial thrombosis and 60% of rheumatic mitral valve disease atrial thrombosis are formed in the left atrial appendage, so it is meaningful to develop the intervention of the left atrial appendage to prevent the risk of stroke complications in patients with atrial fibrillation.

[0003] The existing left atrial appendage occluder occlusion has the following shortcomings:

[0004] 1. Safety problem: Although the left atrial appendage occluder occlusion is a common method for treating atrial fibrillation, there are still some safety hazards in the use process, and the occluder may not be completely occluded or unstable, which may increase the risk of thrombosis, funnel effect or other complications,

[0005] 2. Poor operability: The existing left atrial appendage occluder occlusion has the problems of complex operation, high technical requirements, etc., which may need to be operated by a professional medical team, increasing the risk of surgery and the incidence of complications, in addition, there may be a long-term anticoagulant therapy after the operation, increasing the treatment burden and risk of patients,

[0006] 3. Postoperative effect is unstable: Although the left atrial appendage occluder occlusion can prevent atrial fibrillation patients from developing complications such as stroke to some extent, the postoperative effect may be unstable, and a certain proportion of patients may develop thrombosis or other complications,

[0007] 4. Selection of occluder type: The existing left atrial appendage occlusion has different types of occluders, such as cage-shaped inner plug type and umbrella-shaped outer blocking type, but there may be difficulty in selecting different patients, and no type is suitable for all patients, and needs to be selected according to the specific situation.

[0008] Therefore, it is necessary to design a left atrial appendage foam occluder to solve the above problems. SUMMARY

[0009] The purpose of the present application is to solve the problems existing in the prior art, and the left atrial appendage foam occluder is proposed.

[0010] In order to achieve the above purpose, the technical scheme adopted by the present application is as follows:

[0011] The left atrial appendage foam plugging device comprises a plugging stent and a porous polyurethane foam film, the plugging stent comprises a stent body and a mouth opening tail provided on the stent body;

[0012] The mouth opening tail comprises a plurality of raised connecting rods arranged in a circumferential array;

[0013] A plurality of barbs and a plurality of adaptive rods are arranged on the stent body;

[0014] The plurality of raised connecting rods fold the tissue between the porous polyurethane foam film on the outer surface of the stent body, and form a tissue inlay in the plugging stent.

[0015] As a preferred technical solution of the present application, the plurality of adaptive rods on the stent body are uniformly distributed in the axial direction, and the plurality of adaptive rods have a wave shape structure.

[0016] As a preferred technical solution of the present application, the plurality of adaptive rods on the stent body have a single-segment or multi-segment "S" shape structure.

[0017] As a preferred technical solution of the present application, the wave shapes of the plurality of adaptive rods on the stent body are the same or opposite.

[0018] As a preferred technical solution of the present application, the stent body is connected to the mouth opening tail through the plurality of adaptive rods.

[0019] As a preferred technical solution of the present application, the plurality of raised connecting rods of the mouth opening tail are two single rod raised or concave-convex structure connected single rod raised with a round corner transition.

[0020] As a preferred technical solution of the present application, the plurality of raised connecting rods of the mouth opening tail have the same or different lengths and angles.

[0021] As a preferred technical solution of the present application, the porous polyurethane foam film has a thickness of 0.5-2mm and a pore size of 1-10μm.

[0022] As a preferred technical solution of the present application, the porous polyurethane foam film is sewn to the surface of the stent body by using ultra-high molecular weight polyethylene thread.

[0023] The present application has the following beneficial effects:

[0024] 1. By arranging the adaptive rods, the mouth opening tail of the plugging stent can provide axial freedom, so that it can adapt to various irregular left atrial appendage inner wall shapes, avoid the plugging device being subjected to uneven axial force, ensure more uniform circumferential plugging performance, and reduce the occurrence of blood leakage phenomenon;

[0025] 2. By setting the lifting link of the opening tail on the occlusion support of the left atrial appendage foam occluder, the tissue is folded between the lifting link and the porous polyurethane foam outside the support body, forming the tissue embedded in the occlusion support, which enhances the anchoring force of the left atrial appendage occluder, thereby improving the displacement resistance;

[0026] 3. The foam has a self-expanding effect, and has a better occlusion effect than traditional occluders;

[0027] 4. The foam of the left atrial appendage foam occluder can seal the blood clots that may be generated during implantation in the foam material, reducing the risk of surgery. BRIEF DESCRIPTION OF DRAWINGS

[0028] Figure 1 The structure diagram of the left atrial appendage foam occluder proposed in the application;

[0029] Figure 2 The structure diagram of one of the occlusion supports in the left atrial appendage foam occluder proposed in the application;

[0030] Figure 3 The structure diagram of the barb in the left atrial appendage foam occluder proposed in the application;

[0031] Figure 4 The structure diagram of one of the self-adaptive rods in the left atrial appendage foam occluder proposed in the application;

[0032] Figure 5 The structure diagram of another self-adaptive rod in the left atrial appendage foam occluder proposed in the application;

[0033] Figure 6 The structure diagram of one of the lifting links in the left atrial appendage foam occluder proposed in the application;

[0034] Figure 7 The structure diagram of another lifting link in the left atrial appendage foam occluder proposed in the application;

[0035] Figure 8 The parameter diagram of the structure of the lifting link of the left atrial appendage foam occluder proposed in the application;

[0036] Figure 9 The structure diagram of the left atrial appendage foam occluder when occluded proposed in the application;

[0037] Figure 10 The principle diagram of the axial displacement resistance of the left atrial appendage foam occluder proposed in the application;

[0038] Figure 11 The structure diagram of another occlusion support in the left atrial appendage foam occluder proposed in the application;

[0039] Figure 12 Figure is another structure diagram of the left atrial appendage foam plugging device.

[0040] In the figure: 10, plugging stent; 20, porous polyurethane foam film; 101, stent body; 1011, barb; 1012, adaptive rod; 102, open tail; 1021, uplink. DETAILED DESCRIPTION

[0041] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, not all the embodiments.

[0042] Reference Figures 1-12 , the left atrial appendage foam plugging device, comprising a plugging stent 10 and a porous polyurethane foam film 20, the thickness of the porous polyurethane foam film 20 is 0.5-2mm, the pore size is 1-10μm, the plugging stent 10 includes a stent body 101 and an open tail 102 provided on the stent body 101, the porous polyurethane foam film 20 is sewn to the surface of the stent body 101 by using ultra-high molecular weight polyethylene thread, the stent body 101 is connected with the open tail 102 through a plurality of adaptive rods 1012; the open tail 102 includes a plurality of uplink 1021 distributed in a circumferential array, the plurality of uplink 1021 of the open tail 102 are two single rod uplinks with rounded transitions or two single rod uplinks connected by concave-convex structure, the length and angle of the plurality of uplink 1021 of the open tail 102 are the same or different, the plurality of adaptive rods 1012 on the stent body 101 are uniformly distributed in the axial direction, the plurality of adaptive rods 1012 present a wave shape structure, the plurality of adaptive rods 1012 on the stent body 101 present a single segment or multi-segment “S” shape structure, the wave shape of the plurality of adaptive rods 1012 on the stent body 101 faces the same direction or opposite directions; the stent body 101 is provided with a plurality of barbs 1011 and a plurality of adaptive rods 1012; the plurality of uplink 1021 folds the tissue between the porous polyurethane foam film 20 on the outer surface of the stent body 101, forming a tissue inlay in the plugging stent 10.

[0043] The application provides a left atrial appendage foam plugging device, and a plugging support 10 comprises a support body 101 and an open tail 102; the support body 101 is provided with barbs 1011 and self-adapting rods 1012; the open tail 102 is provided with a raised connecting rod 1021; after the left atrial appendage plugging device is released at a target position, radial support force generated by the proximal end of the plugging support 10 tightly presses a porous polyurethane film 20 between the inner wall tissue of the left atrial appendage and the plugging support 10, so that the left atrial appendage is plugged, and thrombus is prevented from entering and exiting; the barbs 1011 are directly pressed into the inner wall and clamped in the inner wall tissue under the extrusion of the inner wall of the left atrial appendage, and the barbs 1011 provide anchoring force for the left atrial appendage plugging device in the whole heart contraction and diastole process, and prevent the left atrial appendage plugging device from moving axially and rotating radially; when the self-adapting rods 1012 are subjected to the pressure of the inner wall of the left atrial appendage, the self-adapting rods 1012 are adjusted radially and axially according to the shape of the inner wall of the left atrial appendage, so that the plugging support 10 adapts to the irregular shape of the inner wall of the left atrial appendage; the raised connecting rod 1021 arranged on the open tail 102 can be relatively uniformly clamped on the inner wall of the left atrial appendage under the adjustment of the self-adapting rods 1012, the inner wall tissue of the left atrial appendage is folded between the porous polyurethane film outside the self-adapting rods 1012 and the raised connecting rod 1021, an inlaid structure is formed, and the anchoring force of the left atrial appendage plugging device is enhanced, so that the anti-displacement performance is improved.

[0044] As shown in Figures 1-3 The plugging support 10 has a whole bottle plug shape, and the proximal end to the distal end presents a taper; the length L of the barb is about 1-6 mm, and the angle θ of the barb is about 25°-60°; in different embodiments, the length L of the barb and the angle θ of the barb are set according to the thickness of the porous polyurethane foam film in a natural state and under the extrusion of the inner wall of the left atrial appendage; in specific embodiments, the length L of the barb is preferably 4 mm, and the angle θ of the barb is about 45°.

[0045] Further, the number of the barbs 1011 is set according to the shape and mechanical properties of the barbs 1011; in specific embodiments, the number of the barbs 1011 is consistent with the number of meshes on the plugging support 10 body; the connection mode of the barbs 1011 and the plugging support 10 body can be various modes, such as buckle pressing, welding and integral laser cutting; as long as the mechanical properties of the anchoring force are met, in specific embodiments, the barbs 1011 are formed by laser cutting together with the plugging support 10 body and heat treatment; the number of the barbs 1011 is 10, and the dense distribution is 360° around, so that the whole plugging device can be stably anchored at the target position under the action of a pulling force of 30 N after being released to the appropriate position; in some embodiments, the number of the barbs 1011 can be inconsistent with the number of meshes on the plugging support 10 body, and the number of the barbs 1011 is half of the number of meshes.

[0046] As shown in Figure 4The structure of the adaptive rod 1012 is in a wave shape, specifically a single segment or multi-segment "S" shape. The length and wave segment of the adaptive rod 1012 can be consistent or inconsistent. The wave shape of the adaptive rod 1012 can be consistent or inconsistent. The width of the adaptive rod 1012 is 0.8-1 times the width of other support rods on the stent body 101. In specific embodiments, the wave shape of the adaptive rod 1012 is a single-segment "S" shape, uniformly distributed in the circumferential direction, and the wave shape is consistent with the length of the adaptive rod 1012. The width of the adaptive rod 1012 is 0.3 mm, which is smaller than the width of the other support rods on the stent body 101. The width of the adaptive rod 1012 is smaller than the width of the other support rods on the stent body 101, making the adaptive rod 1012 segment softer in the length direction. In addition, the "S" shape of the adaptive rod 1012 provides more deformation space for the adaptive rod 1012 segment, and the three-dimensional deformation freedom of the axial and radial superposition. After the occlusion stent is released at the target position, it can easily adapt to the irregular shape of the left atrial appendage.

[0047] As Figure 5 In some embodiments, the structure of the adaptive rod 1012 is in a continuous two-segment "S" shape, and the wave shape is consistent with the length of the adaptive rod 1012. This makes the waist shape of the occlusion stent 10 more obvious when the occlusion stent 10 is squeezed inside the left atrial appendage, and improves the circumferential displacement resistance of the entire occlusion stent 10.

[0048] As Figure 8 and Figure 9As shown, after the occlusion stent 10 is released at the target position, its two ends are large and the middle is small, showing a tapered shape. At this time, the upturned link 1021 folds the tissue between the upturned link and the porous polyurethane foam film outside the stent body. The upturned link 1021 abuts against the internal tissue of the left atrial appendage. The upturned link 1021 has an acute angle β, and the direction is opposite to the force received by the left atrial appendage during atrial diastole. In this way, the upturned link 1021 can well prevent the left atrial appendage occluder from slipping in the atrial direction during atrial diastole. The mechanical structure of the upturned link 1021 of the open tail 102 can be a round corner transition of two single upturned links, or a concave-convex structure connection of two single upturned links. The upturned link 1021 can be directly heat-set upturned after laser cutting of the stent, or can be connected to the open tail 102 after separate shaping. The length and angle of the upturned link 1021 can be consistent or inconsistent. The width of the upturned link 1021 is 0.6-0.8 times the width of other support rods on the stent body. In a specific implementation, the upturned link 1021 is a round corner transition of two single upturned links. The length L1 of the upturned link 1021 is about 4 mm, and the upturned angle β is 45°. The length and upturned angle of all upturned links 1021 are consistent, and the width is 0.25 mm.

[0049] The above is only the preferred specific implementation of the present application, but the protection scope of the present application is not limited to this. Any person skilled in the art can make equivalent replacements or changes within the technical range disclosed by the present application according to the technical solution and inventive concept of the present application, which should be covered within the protection scope of the present application.

Claims

1. A left atrial appendage foam occluder, characterized by, The occlusion stent (10) comprises a stent body (101) and a mouth opening tail (102) opened on the stent body (101); The mouth opening tail (102) comprises a plurality of raised connecting rods (1021) arranged in a circumferential array; The stent body (101) is provided with a plurality of barbs (1011) and a plurality of adaptive rods (1012); A plurality of the raised connecting rods (1021) fold the tissue between the porous polyurethane foam films (20) on the outer surface of the stent body (101) to form tissue inlay in the occlusion stent (10); The plurality of adaptive rods (1012) on the stent body (101) are uniformly distributed in the axial direction, and the plurality of adaptive rods (1012) present a wave-shaped structure. The plurality of adaptive rods (1012) on the stent body (101) present a single-segment or multi-segment "S" shape.

2. The left atrial appendage foam-patcher of claim 1, wherein, The wave shapes of the plurality of adaptive rods (1012) on the stent body (101) are the same or opposite.

3. The left atrial appendage foam Patcher of claim 1, wherein, The stent body (101) is connected with the mouth opening tail (102) through the plurality of adaptive rods (1012).

4. The left atrial appendage foam Patcher of claim 1, wherein, The plurality of raised connecting rods (1021) of the mouth opening tail (102) are two single-rod raised structures with rounded transitions or two single-rod raised structures connected by concave-convex structures.

5. The left atrial appendage foam Patcher of claim 1, wherein, The lengths and angles of the plurality of raised connecting rods (1021) of the mouth opening tail (102) are the same or different.

6. The left atrial appendage foam Patcher of claim 1, wherein, The thickness of the porous polyurethane foam film (20) is 0.5-2mm, and the pore size is 1-10μm.

7. The left atrial appendage foam Patcher of claim 1, wherein, The porous polyurethane foam film (20) is sewn onto the surface of the stent body (101) by using ultra-high molecular weight polyethylene threads.

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