Plugging device, testing device and testing method

Abstract

The invention relates to a plugging device, a testing device and a testing method.The plugging device comprises a fixing part and a sealing part, the fixing part comprises a plurality of supporting bodies, the sealing part comprises a plurality of weaving wires, the sealing part comprises a dense net structure with the axial tensile capacity, and the testing device is used for testing the axial tensile capacity of the plugging device. After the fixing part and the sealing part are released in sequence, the fixing part pulls the sealing part, and due to the fact that the sealing part has the axial tensile capacity, the sealing part can be maintained at the preset position, when the heart is contracted and relaxed and the pulling force of the fixing part to the sealing part is reduced, a gap cannot be generated between the sealing part and the plugging position, and the sealing effect is good. When the pulling force of the fixing part to the sealing part is increased, the sealing part cannot be pulled to partially leave the plugging position, and therefore the good plugging state is kept all the time.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a blocking device, a testing device and a testing method. Background Art

[0002] In recent years, 90% of strokes caused by atrial fibrillation in patients with non-valvular atrial fibrillation originate from the left atrial appendage. Clinical data show that when atrial fibrillation occurs, the removal of the left atrial appendage during cardiac surgery can reduce the incidence of stroke, which suggests the harm of the left atrial appendage in thromboembolism. Since the left atrial appendage is the nest of thrombi, blocking the opening of the left atrial appendage can eliminate the basis for thrombus formation in the left atrial appendage. Usually, blocking the left atrial appendage with a left atrial appendage occluder is an effective way to prevent stroke caused by atrial fibrillation.

[0003] In order to effectively block the left atrial appendage, the left atrial appendage occluder needs to be implanted in the left atrial appendage for a long time to achieve the blocking effect. Therefore, the left atrial appendage occluder needs to have a certain anchoring structure to enable it to block the left atrial appendage opening stably for a long time, while preventing it from falling off and causing problems such as device embolism.

[0004] For the split occluder, the connection and constraint between the fixing component and the sealing component cannot be completely deformed independently, and one component will be pulled by the other component. For example, once the fixing component is fixed in the left atrial appendage cavity, it will pull the sealing component in the process of conforming to the cavity structure of the left atrial appendage and the movement of the left atrial appendage itself. During the pulling process, the sealing component may not be able to fully fit the mouth of the left atrial appendage, forming a blood leakage channel between the left atrium and the left atrial appendage, thereby failing to achieve the best sealing effect, and then causing the thrombus in the left atrial appendage to flow out of the left atrial appendage, causing a stroke. Summary of the invention

[0005] Based on this, it is necessary to provide an improved occlusion device, a testing device and a testing method to solve the problem of leakage caused by traction in the existing left atrial appendage occluder, as follows:

[0006] Provided is a blocking device, comprising a fixing portion and a sealing portion, wherein the fixing portion comprises a plurality of supporting bodies, the sealing portion comprises a plurality of braided wires, and the sealing portion comprises a dense mesh structure with axial tensile resistance.

[0007] In one embodiment, the braided wire includes a proximal segment, a middle segment and a distal segment arranged in sequence, the wire diameter of the middle segment is smaller than the proximal segment and the distal segment, and the middle segment forms or approaches the edge of the sealing portion after braiding.

[0008] In one embodiment, the proximal segment is woven to form a proximal disk surface, the distal segment is woven to form a distal disk surface, and the wire diameter of the distal segment is smaller than the wire diameter of the proximal segment.

[0009] In one embodiment, the fixing portion and the sealing portion are connected via a connecting portion, and the connecting portion includes an outer sleeve and an inner sleeve connected to each other, the fixing portion is contracted and welded to the distal end of the outer sleeve, and the sealing portion is contracted and fixed to the inner sleeve, thereby achieving the connection between the fixing portion and the sealing portion, and the inner sleeve is flush with the proximal end of the outer sleeve.

[0010] In one embodiment, the total number of the braided wires used in the sealing portion is 144.

[0011] A testing device is also provided, comprising the above-mentioned blocking device, the testing device comprising a hollow main body and a stopper, the inner diameter of the main body is larger than the inner diameter of the stopper, and the stopper is arranged at one end of the main body.

[0012] In one embodiment, the main body and the stopper are integrally formed or detachably connected.

[0013] In one of the embodiments, in an initial state, the fixing portion passes through the block or is located in the block, the sealing portion is located in the main body and close to the bottom of the inner cavity of the main body, and when the test starts, the fixing portion moves along the axis of the main body in a direction away from the main body.

[0014] In one embodiment, the inner diameter of the main body is 6mm-7mm larger than the inner diameter of the stopper.

[0015] In one embodiment, the outer diameter of the sealing portion is at least 6 mm greater than the inner diameter of the stopper.

[0016] A testing method is also provided, comprising the testing device mentioned above, and comprising the following steps: step S1, placing the sealing part of the blocking device into the main body, and the fixing part passes through the block; step S2, the fixing part moves along the axis of the main body in a direction away from the main body, the sealing part gradually deforms, and then the fixing part continues to move; step S3, the sealing part is separated from the testing device, and the maximum tensile force displayed by the sensor is recorded as the axial tensile resistance of the sealing part.

[0017] In one of the embodiments, the convergence portion of the fixing portion is clamped and fixed by a clamp, and the clamp moves along the axis of the main body in a direction away from the main body to drive the fixing portion to move.

[0018] Compared with the prior art, the present invention provides a blocking device, a testing device and a testing method, wherein the blocking device comprises a fixing portion and a sealing portion, wherein the fixing portion comprises a plurality of supporting bodies, the sealing portion comprises a plurality of braided wires, and the sealing portion comprises a dense mesh structure with axial tensile resistance, and the testing device is used to test the axial tensile resistance of the blocking device, and during implantation, the fixing portion and the sealing portion are released in sequence, so that the fixing portion pulls the sealing portion, and since the sealing portion has axial tensile resistance, the sealing portion can be maintained at a predetermined position, and when the heart contracts and relaxes, when the pulling force of the fixing portion on the sealing portion decreases, a gap will not be caused between the sealing portion and the blocking position, and when the pulling force of the fixing portion on the sealing portion increases, the sealing portion will not be pulled and partially leave the blocking position, thereby always maintaining a good blocking state. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 is a schematic structural diagram of the blocking device in the natural state in Example 1 of the present invention;

[0020] Figure 2 is a schematic diagram of the state of the blocking device in Example 1 of the present invention in a normal blocking state;

[0021] Figure 3 is a schematic diagram of the state of the blocking device in Example 1 of the present invention when the traction force of the fixed disk is too small;

[0022] Figure 4 is a schematic diagram of the state of the blocking device in Example 1 of the present invention when the traction force of the fixed disk is too large;

[0023] Figure 5 is a schematic diagram of the structure of the test device in Example 1 of the present invention;

[0024] Figure 6 is a schematic diagram of the initial state of the axial tensile strength test of the blocking device in Example 1 of the present invention;

[0025] Figure 7 is a schematic diagram of the motion state of the axial tensile strength test of the blocking device in Example 1 of the present invention;

[0026] Figure 8 is a schematic diagram of the end state of the axial tensile strength test of the blocking device in Example 1 of the present invention;

[0027] Fig. 9 is a schematic structural diagram of a testing device in another embodiment of the present invention;

[0028] Fig.10 is a schematic structural diagram of a blocking device in Embodiment 2 of the present invention;

[0029] Fig.11is a schematic diagram of the distal end surface of the blocking device in Example 3 of the present invention;

[0030] Fig.12 is a schematic assembly diagram of the connection portion of the blocking device according to Example 1 of the present invention;

[0031] Fig.13 is a schematic assembly diagram of the connection portion of the blocking device according to Embodiment 4 of the present invention;

[0032] Fig.14 is a schematic structural diagram of a sealing portion of a blocking device after deformation in Embodiment 5 of the present invention;

[0033] Fig.15 yes Fig.14 A schematic diagram of the structure of the film body of the sealing portion of the plugging device in the state;

[0034] Fig.16 It is a schematic diagram of the state of the blocking device in the delivery sheath tube without a flexible member arranged between the first film body and the second film body;

[0035] Fig.17 for Fig.16 Schematic diagram of the state of the film structure of the middle plugging device after release;

[0036] Fig.18 is a schematic cross-sectional view of the edge position of the first film body of the blocking device in Example 5 of the present invention;

[0037] Fig.19 A schematic diagram of the connection method of the edge position of the second film body of the blocking device in Example 5 of the present invention;

[0038] Fig. 20 This is the bundling method of the braided wires at the proximal end of the sealing portion of the occluding device in Example 5 of the present invention. DETAILED DESCRIPTION

[0039] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0040] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in a human or animal body that is closer to the operator is generally referred to as the "proximal end", and the end that is farther from the operator is referred to as the "distal end", and the "proximal end" and "distal end" of any component of the medical device are defined based on this principle. "Axial" generally refers to the length direction of the medical device when it is transported, and "radial" generally refers to the direction of the medical device perpendicular to its "axial direction", and the "axial" and "radial" of any component of the medical device are defined based on this principle. The "connection" mentioned in the embodiments includes the situation where two components are directly connected and indirectly connected with the help of other components.

[0041] The technical solution of the present invention will be further described in detail below in conjunction with specific embodiments.

[0042] Example 1

[0043] The occluding device provided in Example 1 can be used to occlude the left atrial appendage, and can also be used to occlude other body tissues with openings, including but not limited to atrial septal defect, patent ductus arteriosus, etc. The occluding device will be described in detail below using the occlusion of the left atrial appendage as an example.

[0044] Please refer to Figure 1 , Figure 1 1 is a schematic diagram of the structure of the occluding device 100 in the natural state in Example 1 of the present invention. The occluding device 100 includes a fixing portion 120 and a sealing portion 110 connected to the fixing portion 120. The sealing portion 110 and the fixing portion 120 are arranged at intervals along the axial direction of the occluding device 100. The sealing portion 110 is located at the proximal end of the occluding device 100, and the fixing portion 120 is located at the distal end of the occluding device 100. The occluding device 100 has a compressed state contained in the sheath for easy delivery, and extends from the distal end of the sheath and expands after self-expansion. Figure 1 The occlusion device 100 is in the expanded state after being released in the cavity of the left atrial appendage. Figure 1 In other implementations, for example, when used for atrial septal defect occlusion, the sealing portion 110 and the fixing portion 120 may be brought closer to each other after being released to fix the occlusion device 100 on the interval between the left atrium and the right atrium.

[0045] The sealing part 110 is woven into a mesh tube by a plurality of braided wires 111, and the ends of the braided wires 111 are closed and fixed by a sleeve at each end of the mesh tube. The mesh tube is then heat-formed into a disc-like, columnar or plug-like shape, thereby obtaining a sealing part 110 for blocking the opening of the left atrial appendage. The sealing part 110 includes a distal disk surface 112 facing the fixing part 120, and a proximal disk surface 113 opposite to the distal disk surface 112. The interior of the sealing part 110 is provided with at least one layer of a thin film body (not shown) used as a flow-blocking membrane, and the edge of the thin film body is fixed on the braided wires 111 at the edge of the sealing part 110, generally fixed by sutures, and the thin film body is between the distal disk surface 112 and the proximal disk surface 113. The thin film body is used to prevent blood flow from flowing from one side of the sealing part 110 to the other side, so as to prevent blood flow from flowing between the left atrial appendage and the left atrium. In the present embodiment, the total number of braided wires 111 used in the sealing portion 110 is increased. On the one hand, a larger number of braided wires can objectively better block the blood flow and support the flow-blocking membrane, thereby achieving a better sealing effect. On the other hand, the disk edge of the woven sealing portion 110 can be made up of more wires, thereby further filling the gaps at the edge, thereby obtaining a smoother disk edge, and then making it fit more closely with the inner wall of the left atrial appendage compared to the traditional setting. In the present embodiment, the total number of braided wires 111 exceeds 72 strands, that is, the sealing frame of the sealing portion 110 is a dense mesh structure.

[0046] In another embodiment, when the sealing frame of the sealing portion 110 is a dense mesh structure, the mesh structure formed by the braided wires 111 is dense enough to prevent the blood clots in the auricle from flowing out, thereby eliminating the need for a flow-blocking membrane.

[0047] The fixing part 120 includes at least one support 122 and a coating 121 covering the surface of the support 122, and the sealing part 110 is directly or indirectly connected to the fixing part 120. The support 122 on the fixing part 120 can be a rod obtained by cutting a metal alloy tube or a polymer tube, or can be a rod made by weaving or winding a braided wire. In this embodiment, the specific shape of the support 122 is not limited. In order to improve the anchoring ability of the fixing part 120, an anchor barb 123 is provided on the fixing part 120 in this embodiment.

[0048] In this embodiment, the distal disk surface 112 of the sealing portion 110 facing the fixing portion 120 is converged, and the proximal end of the fixing portion 120 is also converged, and the direct or indirect connection position between the two is the converged position.

[0049] In this embodiment, the sealing portion 110 and the fixing portion 120 are fixedly connected by a connecting portion 130 .

[0050] In another embodiment, the sealing portion 110 and the fixing portion 120 are connected by a connecting portion 130 , and the fixing portion 120 and the sealing portion 110 can rotate relative to each other.

[0051] In another embodiment, the sealing portion 110 and the fixing portion 120 are integrally formed.

[0052] Using the occlusion device 100 of this embodiment, after implantation, refer to Figure 2 , Figure 2 It is a schematic diagram of the state of the occluding device 100 in Example 1 of the present invention under a normal occluding state. The support body 122 of the fixing part 120 expands to resist the inner wall of the left atrial appendage 11, and the anchor barb 123 penetrates into the inner wall of the left atrial appendage 11, thereby helping the fixing part 120 to support the body. When the occluding device is working normally, the sealing part 110 covers the mouth 12 of the left atrial appendage 11. However, since the sealing part 110 is maintained at the position of the mouth 12 of the left atrial appendage by the fixing part 120, the sealing part 110 is always pulled by the fixing part 120. In addition, due to the contraction and relaxation movement of the heart itself, in order to prevent the sealing part 110 from being separated from the position of the mouth 12, it is preferred that the sealing part 110 is deformed during implantation, that is, the sealing part 110 is pulled by the fixing part 120 when released, so that the sealing part 110 can always block the mouth 12 of the left atrial appendage. However, also because of this, the traction force of the fixing portion 120 on the sealing portion 110 is preferably maintained at an appropriate level.

[0053] When selecting an implant site, refer to Figure 3 , Figure 3 1 is a schematic diagram of the state of the occlusion device 100 in Example 1 of the present invention when the traction force of the fixing plate 110 is too small. If the traction force of the fixing part 120 on the sealing part 110 is too small, or even there is no traction force or there is a thrust force (that is, the fixing part 120 is too close to the left atrial appendage opening 12 during implantation), the fixing part 120 will not pull the sealing part 110 to cover the left atrial appendage opening 12. As the heart contracts and relaxes, the anchor thorn 123 of the fixing part 120 pierces the inner wall of the left atrial appendage 11, thereby causing The relative position of the fixing part 120 and the left atrial appendage 11 remains unchanged, the fixing part 120 follows the deformation and movement of the inner wall of the atrial appendage, and the relative position of the fixing part 120 and the sealing part 110 changes. When the two are close to each other, the pulling effect of the fixing part 120 on the sealing part 110 is reduced or even reversed to a thrust (because the fixing part 120 is too close to the left atrial appendage opening 12 during implantation), so that the edge of the sealing part 110 cannot cover and resist the left atrial appendage opening 12 well, thereby resulting in reduced sealing effect or sealing failure.

[0054] In other words, since the heart is beating continuously during the implantation process, if the traction force exerted by the fixing portion 120 on the sealing portion 110 is too small or even non-existent, when the initial state of the implantation is when the sealing portion 110 and the fixing portion 120 are relatively close to each other, the fixing portion 120 of the occluding device 100 can still pull the sealing portion 110 during the deformation process, so that the occluding effect still exists. However, when the initial state of the implantation is not when the sealing portion 110 and the fixing portion 120 are relatively close to each other, or even when they are relatively far from each other, the subsequent deformation causes the fixing portion 120 to approach the sealing portion 110, causing the traction force to decrease or even reverse, which will cause the sealing portion 110 to leak or completely move out of the occluding position, thereby causing a stroke.

[0055] Therefore, in order to avoid the above situation, during operation, the fixing part 120 can be implanted at a distance from the left atrial appendage 12, so that the fixing part 120 can already pull the sealing part 110 when implanted. However, in such a case, if the axial tensile strength of the sealing part 110 is too small, the traction force of the fixing part 120 on the sealing part 110 is large and the pulling effect is strong, and the fixing part 120 pulls the sealing part 110 into the interior of the left atrial appendage 11, such as Figure 4 As shown, Figure 4 It is a schematic diagram of the state of the occluding device 100 in Example 1 of the present invention when the traction force of the fixed disk 120 is too large, which causes its occluding position to change. On the one hand, the size of the sealing portion 110 is generally selected according to the size of the left atrial appendage opening 12. When the sealing portion 110 passes through the left atrial appendage opening 12, its size may not be able to completely block the internal area of ​​the left atrial appendage, which is prone to leakage. On the other hand, the sealing position of the sealing portion 110 is too deep, which may easily lead to part of the pectinate muscle area not being blocked, that is, the left atrial appendage is not completely blocked, and it is also a situation where the occluding device cannot fully fit the opening of the left atrial appendage.

[0056] On the whole, when setting the sealing part 110, it is necessary to make the sealing part 110 have a certain axial tensile resistance, so that the sealing part 110 is in a tensioned state during implantation but will not be pulled into the interior of the atrial appendage, thereby obtaining a good sealing effect. That is, the sealing part 110 must have a certain axial tensile resistance, so that the sealing part 110 can always maintain the position of the left atrial appendage opening 12 after implantation.

[0057] The corresponding axial tensile strength test method is as follows:

[0058] like Figure 5 As shown, Figure 5It is a structural schematic diagram of the test device 200 in Example 1 of the present invention. The test device 200 includes a main body 210 and a stopper 220. The main body 210 includes a hollow cylindrical structure. The stopper 220 includes a hollow cylindrical structure. The inner diameter of the stopper 220 is smaller than the inner diameter of the main body 210, and the stopper 220 is arranged at one end of the main body 210. In this embodiment, the main body 210 and the stopper 220 are fixedly connected.

[0059] The block 220 is used to simulate the opening of the left atrial appendage, and the inner cavity of the main body 210 is used to accommodate the sealing part 110. At the beginning of the test, the sealing part 110 is placed in the main body 210, and the fixing part 120 passes through or is located in the block 220. The convergence part of the fixing part 120 is clamped and fixed by the clamp 230. The movement of the clamp 230 can drive the movement of the fixing part 120. A sensor is set on the clamp 230 or connected to a tensile testing machine to measure the axial tension of the clamp 230 along the main body 210.

[0060] It should be noted that the clamp 230 can also be replaced by other devices as long as it can drive the fixing part 120 to move. Figure 6-8 , Figure 6 is a schematic diagram of the initial state of the axial tensile strength test of the blocking device 100 in Example 1 of the present invention, Figure 7 is a schematic diagram of the motion state of the axial tensile strength test of the blocking device 100 in Example 1 of the present invention, Figure 8 Schematic diagram of the end state of the axial tensile strength test of the blocking device 100 in Example 1 of the present invention; in the initial state, the clamp 230 clamps the fixing part 120 in the initial position, and the sealing part 110 is close to the bottom of the inner cavity of the main body 210, that is, one side of the stopper 220. At the beginning of the test, the clamp 230 moves along the axis of the main body 210 in a direction away from the main body 210. The specific test steps are as follows:

[0061] Step S1, the sealing part 110 of the blocking device is placed into the main body 210, the fixing part 120 passes through the stopper 220, and the convergent part of the fixing part 120 is clamped and fixed by the clamp 230;

[0062] Step S2, the clamp 230 moves along the axis of the main body 210 in a direction away from the main body 210, the sealing part 110 gradually deforms, and then the fixing part 120 continues to move;

[0063] Step S3 , the sealing part 110 is separated from the testing device 200 , and the maximum tensile force displayed by the sensor is recorded as the axial tensile resistance of the sealing part 110 .

[0064] It should also be noted that the sizes of the sealing part 110 and the stopper 220 cannot be selected arbitrarily. In this embodiment, the outer diameter of the sealing part 110 exceeds the inner diameter of the stopper 220 by at least 6 mm in the unstressed state, which also corresponds to the implant selection of the general split-type occluding device; for a certain occluding device, since the smaller the inner diameter of the stopper 220 is, the greater the tensile force required for the sealing part 110 to pass through the stopper 220, therefore, the test of the expected axial tensile resistance of the sealing part 110 should select the stopper 220 with the largest inner diameter, that is, the axial tensile resistance of the sealing part 110 directly corresponds to the minimum axial tensile force required for the sealing part 110 to pass through an opening 6 mm smaller than its diameter from a natural state. The greater the minimum axial tensile force required for the sealing part 110 to pass through an opening 6 mm smaller than its diameter from a natural state, the greater the axial tensile resistance of the sealing part 110; the smaller the minimum axial tensile force required for the sealing part 110 to pass through an opening 6 mm smaller than its diameter from a natural state, the smaller the axial tensile resistance of the sealing part 110.

[0065] In this embodiment, in order to avoid horizontal displacement of the sealing part 110, the size of the main body 210 is set to be slightly larger than the size of the sealing part 110 (approximately 1 mm larger or equal to the size of the sealing part 110. When they are equal, the inner wall of the main body 210 exerts less deformation pressure on the sealing part 110 due to the better flexibility of the sealing part 110). That is, the inner diameter of the main body 210 is larger than the inner diameter of the block 220 by 6 mm-7 mm.

[0066] In this embodiment, the block 220 may also have a certain depth. On the one hand, it is conducive to the sealing part 110 to completely enter the area of ​​the block 220, and to avoid the distal part of the sealing part 110 leaving the area of ​​the block 220 when the edge of the sealing part 110 enters the block 220, which affects the test results. On the other hand, during the test, when the sealing part 110 enters the inside of the block 220 and moves along the inner wall of the block 220, the sensor displays a relatively stable value of the friction force of the inner wall of the block 220 overcome by the sealing part 110. The peak tension before this data is the minimum axial tension of the sealing part 110.

[0067] In this embodiment, the main body 210 and the block 220 are integrally formed, thereby ensuring the connection strength between the main body 210 and the block 220 and leaving no gap therebetween, thereby ensuring the accuracy of the test. When it is necessary to test blocking devices 100 of different sizes, multiple test devices 200 of different sizes can be manufactured.

[0068] In another embodiment, if Fig. 9 As shown, Fig. 9 It is a schematic diagram of the structure of a test device in another embodiment of the present invention, in which the main body 210 and the stopper 220 are detachably connected, preferably threadedly connected (the thread is not shown), so that the stopper 220 with different inner diameters can be replaced as needed to meet different test needs.

[0069] As mentioned above, in this embodiment, the total number of braided wires 111 exceeds 72 strands, that is, the sealing frame of the sealing portion 110 is a dense mesh structure. Further, the total number of braided wires 111 used in the sealing portion 110 is preferably 144 strands.

[0070] After the sealing frame of the sealing part 110 is a dense mesh structure, in order to avoid the weaving difficulties caused by increasing the number of braiding wires 111 and the difficulty of the sealing part 110 in getting in and out of the sheath, the wire diameter of the braiding wire 111 is usually reduced. It should be noted that the reduction in wire diameter will lead to a decrease in the overall strength index of the sealing part 110 rather than a simple positive correlation decrease. Therefore, after the number of braiding wires 111 increases, the sealing part 110 will be softer as a whole and can actually fit the left atrial appendage better, but it will increase the risk of the fixing part 120 pulling the sealing part 110.

[0071] Therefore, for the blocking device 100 of this embodiment, the total number of braided wires of the sealing portion 110 is greater than 72, and has a certain axial tensile strength, preferably a minimum axial tensile strength greater than 0.12N, so as to achieve a better blocking effect.

[0072] Example 2

[0073] The only difference between this embodiment and the first embodiment is that the sealing portion 110 of this embodiment is provided with a special braided wire 111 structure. Fig.10 , Fig.10 It is a structural schematic diagram of the occluding device in Example 2 of the present invention, the sealing portion 110 includes a distal disk 112 facing the fixing portion 120, and a proximal disk 113 opposite to the distal disk 112, the sealing portion 110 is woven from braided wires 111, and the braided wires 111 of this embodiment include a proximal segment 1111, a middle segment 1112 and a distal segment 1113, wherein the wire diameter of the middle segment 1112 is the smallest, and the middle segment 1112 forms or approaches the edge portion of the sealing portion 110 after braiding, thereby making the edge portion of the sealing portion 110 softer and fitting more closely to the implantation position.

[0074] Since the axial tensile strength is more affected by the strength of the distal disk 112 and the proximal disk 113 of the sealing part 110 (when the sealing part 110 is pulled by the fixing part 120, the sealing part 110 is actually required to deform to reduce its diameter and thus move), the design of this embodiment only reduces the regional wire diameter of the edge part of the sealing part 110, thereby basically maintaining the overall axial tensile strength of the sealing part 110.

[0075] The braided wire in the present embodiment is a nickel-titanium alloy, and the wire diameters of the proximal segment 1111 and the distal segment 1113 are preferably equal. In another embodiment, the wire diameter of the distal segment 1113 is smaller than the wire diameter of the proximal segment 1111. Since the proximal segment 1111 is woven to form the proximal disk 113 and the distal segment is woven to form the distal disk 112, the proximal disk 113 has greater strength and can maintain the stability of the disk shape, while the distal disk 112 has better flexibility and can be deformed to better fit the inner wall of the auricle. At the same time, the deformation can further reduce the tension from the fixing portion 120.

[0076] Example 3

[0077] The only difference between this embodiment and the first embodiment is that the sealing portion 110 of this embodiment is changed. Fig.11 , Fig.11 It is a schematic diagram of the distal end face of the blocking device in Example 3 of the present invention. In this embodiment, a plurality of flexible parts 140 are added to the sealing part 110. The flexible parts 140 are passed through and fixed on the distal side of the sealing part 110. Since the tension from the fixed part is from the distal side of the sealing part 110, when subjected to axial tension, the flexible parts 140 distribute part of the tension transmitted by the deformation to other areas to make the stress more dispersed, thereby avoiding excessive deformation of the fixed part 120 causing excessive deformation of some areas of the sealing part 110, thereby improving the overall axial tensile resistance of the sealing part 110 as a whole. At the same time, the flexible parts 140 themselves also have a certain restraining effect, which can improve the overall axial tensile resistance of the sealing part 110.

[0078] In this embodiment, the flexible member 140 is passed through and fixed on the distal side of the sealing portion 110 , so as to keep the proximal disk surface of the sealing portion 110 flat, thereby reducing the possibility of thrombus formation.

[0079] It should be noted that, since the flow-blocking film is also sewn into the sealing portion 110, the sewing position of the flexible member 140 is located at the distal end of the flow-blocking film, thereby avoiding damage to the integrity of the flow-blocking film. At the same time, the suture nodes (i.e., the knotting points of the sutures) for fixing the thin film body forming the flow-blocking film are all arranged at the distal end of the film body, which can also play the same effect of maintaining the flatness of the proximal disk surface of the flow-blocking film. The suture nodes here refer not only to the suture nodes at the edge position, but also to any suture nodes that pass through the flow-blocking film and play a fixing role.

[0080] In addition, in this embodiment, the number of flexible parts 140 can be multiple, and they can also be interconnected or independent of each other. As long as the two ends of the flexible parts 140 are connected to the same side end surface of the sealing part 110, they can play a role in distributing stress. However, multiple flexible parts 140 connected to each other can achieve better results.

[0081] In this embodiment, the flexible member 140 may be selected from sutures or other biocompatible materials. For example, the flexible member 140 may be selected from nickel-titanium wire, that is, nickel-titanium wire is additionally added to the distal end face of the sealing portion 110. The flexible member 140 does not participate in the braiding, but the two ends are respectively connected to the braided wire, thereby utilizing the strength of the flexible member 140 itself to increase the overall axial tensile strength of the sealing portion 110. In another embodiment, in order to avoid the use of a higher strength material for the flexible member 140 affecting the entry and exit of the sheath, the flexible member 140 is arranged to be distributed along the radial direction (when there are multiple flexible members 140, they are spaced apart from each other along the radial direction), so that it does not affect the sheathing of the sealing portion 110.

[0082] Example 4

[0083] The only difference between this embodiment and the first embodiment is that the connection portion 130 of this embodiment is changed. Fig.12 , Fig.12 It is an assembly diagram of the connecting portion 130 of Example 1 of the present invention, wherein the connecting portion 130 includes an outer sleeve 1311 and an inner sleeve 1312 that are connected to each other, the fixing portion 120 is converged and welded to the distal end of the outer sleeve 1311, and the sealing portion 110 is converged and welded to the inner sleeve 1312, thereby realizing the connection between the fixing portion 120 and the sealing portion 110. Preferably, the inner sleeve 1312 is flush with the proximal end of the outer sleeve 1311, thereby preventing a sleeve from protruding to form a sharp protrusion and damaging the bent portion of the sealing portion 110.

[0084] like Fig.13 As shown, Fig.13 It is an assembly diagram of the connection part of the blocking device of Example 4 of the present invention. In this embodiment, the outer sleeve 1311 of the connection part 130 includes a distal part 13111 and a proximal part 13112, wherein the distal part 13111 and the proximal part 13112 are movably connected via a movable device 13113.

[0085] In this embodiment, the movable device 13113 can adopt a ball head structure. The movable device 13113 is a ball head. One end of the movable device 13113 is fixed to the proximal part 13112, and the other end is inserted into a groove of the distal part 13111. It should be noted that in order to prevent the ball head from falling out, the opening diameter of the groove of the distal part 13111 is smaller than the diameter of the ball head. During manufacturing, the elasticity (nickel-titanium alloy) of the opening of the groove of the distal part 13111 can be used to directly insert the ball head into the opening. In this embodiment, the sealing portion 110 can be axially deflected relative to the fixing portion 120. Due to the characteristics of the left atrial appendage, generally, there is an angle between the axis of the implantation position of the fixing portion 120 and the axis of the implantation position of the sealing portion 110. That is, after using the structure of this embodiment, the implanted sealing portion 110 and the fixing portion 120 are not on the same axis. Therefore, the axial tension of the fixing portion 120 is deflected after passing the position of the movable device 13113, and only a part of the component of the tension continues to be transmitted toward the axial direction of the sealing portion 110, thereby objectively improving the overall axial tensile resistance of the occluding device.

[0086] As described in the previous embodiments, the left atrial appendage will repeatedly contract and relax with the heart, so that when the occlusion device deforms with the heart, the relative positions of the fixing portion 120 and the sealing portion 110 and the angle formed by the axes of the two will also continuously change, that is, the fixing portion 120 and the sealing portion 110 will continuously deflect. In this case, the component of the pulling force of the fixing portion 120 on the sealing portion 110 along the sealing portion 110 will also continuously change. It should also be noted that the contraction of the heart is an overall rotational contraction, which can easily lead to a larger deflection of the fixing portion 120, so that the axis of the fixing portion 120 deflects more relative to the axis of the sealing portion 110, and the angle formed by the two axes is larger, so that the pulling force generated by the fixing portion 120 along the axis of the sealing portion 110 is smaller.

[0087] In another embodiment, the outer sleeve 1311 of the connecting part 130 can be further optimized, and the outer sleeve includes a distal portion 13111 and a proximal portion 13112, wherein the distal portion 13111 and the proximal portion 13112 are connected by a buffer device, preferably an elastic member, or the ball head structure of the movable device itself is set as an elastic member to act as a buffer device. Therefore, in this embodiment, the fixing part 120 and the sealing part 110 are movable axially at the position of the connecting part 130.

[0088] As described in the previous embodiments, the left atrial appendage will repeatedly contract and relax following the heart, causing the occluding device to repeatedly deform when deforming, and the fixed portion 120 will also reciprocate following the movement of the inner wall of the left atrial appendage, causing the magnitude of the pulling force pulling the sealing portion 110 to change in a roughly repeated trend (it should be noted that due to changes in the human body environment, it is unlikely that the magnitude of the pulling force for each deformation will be exactly the same, but the trend of the force magnitude in a contraction-relaxation process is roughly the same). When the pulling force of the fixed portion 120 is transmitted to the sealing portion 110 through the movable device 13113, the movable device (or ball head) acts as a buffer device for buffering, so that the axial pulling force on the sealing portion 110 changes less. At the same time, since the buffer device will deform when transmitting force, the transmission of force will be partially delayed, and the deformation of the fixed portion 120 due to the reciprocating deformation may cause its subsequent deformation to offset the pulling force transmitted by the previous deformation, thereby further amplifying the buffering effect of the buffer device, thereby improving the axial tensile resistance of the occluding device. In other words, the buffer device also improves the axial tensile resistance of the occluding device by prolonging the force transmission time.

[0089] In another embodiment, the movable device 13113 may be a combination of a ball head and a buffer device, so that the two devices do not interfere with each other when performing their functions, thereby playing a role in better improving the axial tensile strength of the blocking device.

[0090] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0091] Example 5

[0092] On the basis of the above-mentioned embodiment, the film body inside the sealing part 110 can also be improved. As mentioned in the previous embodiment, the edge of the film body is fixed on the braided wire 111 at the edge of the sealing part 110, generally fixed by sutures, and the film body is between the distal disk surface 112 and the proximal disk surface 113.

[0093] Reference Fig.14 , Fig.14 is a schematic diagram of the structure of the sealing portion 110 after deformation in this embodiment. This figure is to further show the specific distribution of the film body in the sealing portion 110. Fig.15 , Fig.15 In this embodiment Fig.14 The schematic structural diagram of the film body of the sealing portion 110 of the blocking device 100 in the state should be explained. Fig.15 In order to further explain the sealing part of the blocking device of this embodiment, Fig.14A schematic diagram for illustration, that is, Fig.14 In the deformed state, the film body inside the sealing portion 110 in this embodiment is as follows Fig.15 status in .

[0094] In order to achieve a good sealing effect for the sealing part 110, the sealing part 110 includes at least two layers of thin film bodies, and the second thin film body 312 is located at the distal end of the first thin film body 311. Specifically, the edge of the first thin film body 311 is fixed at the first position 301 of the sealing frame of the sealing part 110 (i.e., the braided structure formed by the braided wire), and the edge of the second thin film body 312 is fixed at the second position 302 of the sealing frame of the sealing part 110. The fixing method is not limited to suture suturing, bonding, etc. After implantation, the sealing part 110 is close to the inner wall of the auricle, thereby driving the edge of the first thin film body 311 and / or the second thin film body 312 to be close to the inner wall of the auricle, so that the first thin film body 311 and / or the second thin film body 312 are opened and close to the inner wall of the auricle, thereby ensuring a good blocking effect.

[0095] It should be noted that the first position 301 and the second position 302 are intended to show the relative relationship of the positions, that is, the first position 301 is located at the proximal end of the second position 302, but it does not mean that the first position 301 and the second position 302 must be set at the exact position of the sealing part 110, nor does it mean that the interval between the first position 301 and the second position 302 must correspond to the scale of the drawings of this embodiment.

[0096] Preferably, the edge of the first film body 311 and the edge of the second film body 312 are sewn to multiple intersections between two wires of the woven mesh of the sealing portion 110 through multiple sewing points to avoid excessive slippage of the edges.

[0097] Preferably, the first film body 311 is connected to the second film body 312 through the flexible member 313, so that the volume of the cavity between the first film body 311 and the second film body 312 is not too large, and the first film body 311 and the second film body 312 can be deformed as a whole or in linkage with the deformation of the sealing portion 110, thereby avoiding the first film body 311 and the second film body 312 from being randomly deformed and causing undue external force and external force to be concentrated on a certain film body, refer to Figure 16-17 , Fig.16 is a schematic diagram of the state of the thin film structure of the blocking device in the delivery sheath tube when the flexible member is not provided. Fig.17 3 is a schematic diagram of the state of the film structure of the blocking device after release when the flexible member is not provided. It can be seen that the first film body 311 and the second film body 312 are independent of each other. When there is no flexible member 313 connected, it is easy to appear in the sheath tube. Fig.16The arrangement in the figure, that is, the middle parts of the first film body 311 and the second film body 312 are far away from each other. If released in this state, when the sealing part of the occluding device just abuts against the inner wall of the left atrial appendage after being released, the film body structure will follow the sealing frame to present Fig.17 state, at this time, a cavity is formed between the first film body 311 and the second film body 312, the middle parts of the first film body 311 and the second film body 312 are far away from each other, and the volume of the cavity between the first film body 311 and the second film body 312 is the largest. At the same time, the position to be blocked by the blocking device as a whole is on the distal side of the first film body 311 (i.e., the upper side of the figure). When the sealing frame moves with the beating of the heart, the blocked fluid (blood, airflow, thrombus, etc.) on the distal side of the first film body 311 will squeeze the first film body 311, causing the first film body 311 to deform toward the proximal side, thereby squeezing the cavity between the first film body 311 and the second film body 312; after the squeezed cavity is deformed, the stress is transmitted toward the second film body 312. Since the edge of the first film body is fixed to the sealing frame, the middle part of the first film body faces the distal end when it is just released, that is, in the initial state, the volume of the cavity is at its maximum. During the process of the first film body being compressed and deforming toward the proximal end and the first film body Before the middle part of the first film body 311 passes over 201, the middle part of the first film body 311 is almost not pulled by the edge connection position, and the middle part of the first film body 311 has almost no resistance to the fluid impact from the distal side, and its stress is substantially all transmitted to the second film body 312; in this case, on the one hand, the fluid in the cavity may flow out along the gap between the film body and the sealing frame (especially the gap between the second film body 312 and the sealing frame), and on the other hand, when the cavity between the first film body 311 and the second film body 312 is squeezed, the deformation space left is small, and the fluid pressure in the cavity is likely to expand the gap between the first film body 311 and / or the second film body 312 and the external frame, thereby resulting in a decrease in the sealing effect.

[0098] In this embodiment, further reference is made to Figure 18-19 , Fig.18 is a schematic cross-sectional view of the edge of the first film body of the blocking device in Example 1 of the present invention, Fig.19 This is a schematic diagram of the connection method of the edge position of the second film body of the blocking device in Example 1 of the present invention, that is, Fig.18 is the cross-sectional view perpendicular to the axis, and Fig.19 This is the same front view perspective as the other figures.

[0099] The first film body 311 and the second film body 312 are fixed to the braided wire 111 in different ways. The braided wire 111 is located outside the first film body 311 and the second film body 312, as follows:

[0100] For the first film body 311, see Fig.18 The first film body 311 is fixed to the braided wire 111 through the first connecting piece 331. Specifically, the first connecting piece 331 is interlaced and circumvented along the horizontal direction (that is, the circumferential direction), and sequentially passes through the intersection of the first film body 311 and the wires of the braided wire 111 or the wires in the frame, thereby fixing the edge of the first film body 311 to the braided wire 111. The first connecting piece 331 is a flexible piece, preferably a suture, and either multiple sutures or a continuous line can be selected. In this embodiment, the position where the first connecting member 331 passes through the braided wire 111 (i.e., the position on the braided wire 111 where the first connecting member 331 is wrapped around the outside of the braided wire 111) is recorded as the passing point of the braided wire 111, and the braided wire 111 includes multiple passing points, and a part of the first connecting member 331 is located outside the passing point. It can also be understood that, in the circumferential direction of the same cross-section, there are several exposed wires (or the intersection points of multiple wires) between two adjacent passing points. In this embodiment, preferably, there is one exposed wire (or the intersection point of one wire) between two adjacent passing points, so that the first film body 311 is fixed evenly and densely. It should also be noted that since the first connecting member 331 adopts a circumferential threading method at the threading point, that is, at a single threading point, the portion of the first connecting member 331 located outside the braided wire 111 extends along the circumferential direction (the extension direction of the portion of the first connecting member 331 located outside the threading point is along the circumferential direction), in such a case, when the braided wire 111 is deformed, the first connecting member 331 will not generate additional tension on the braided wire 111, and when the braided wire 111 is under pressure, the braided wire 111 will not cause the threading point of the first connecting member 331 to shrink synchronously with the braided wire 111, thereby, in addition to the deformation of the first film body 311 due to the deformation of the braided wire 111 itself, the design of the first connecting member 331 will not cause the sealing frame to drive the first film body 311 at the threading point to deform synchronously, thereby causing excessive wrinkles or gaps on the edge of the first film body 311, so that the first film body 311 is kept in an open shape as much as possible. In addition, since there is a gap between two adjacent penetration points, a buffer is left for the connection between the edge of the first film body 311 and the braided wire 111, so that the first film body 311 is less affected by the stress of the connection position.

[0101] To indicate the specific position of the first connecting member 331 located outside the penetration point, see Fig.18The threading section 2311 of the first connector 331 refers to a portion of the first connector 331 at a threading point, which is located outside the braided wire 111 and has the braided wire 111 as the boundary. The extension direction of the threading section 2311 is distributed circumferentially, that is, the extension direction of the portion of the first connector 331 located outside the threading point referred to in this embodiment is along the circumferential direction. It should be noted that the first connector 331 can bypass the threading point multiple times, but the threading section 2311 only refers to a portion of the first connector 331 that is located outside the braided wire 111 and has the braided wire 111 as the boundary.

[0102] It is also worth mentioning that, since the braided wire 111 is in a compressed state after implantation, no large gap will be left between the first film body 311 and the braided wire 111 after implantation.

[0103] In another embodiment, the positions of the threading points of the braided wires 111 are located at the intersections between the braided wires 111 , and there are two exposed intersections between two adjacent threading points.

[0104] In another embodiment, the positions of the threading points of the braided wires 111 are at the intersections between the braided wires 111 , and the number of the intersections between the wires between each group of two adjacent threading points is not completely equal.

[0105] For the second film body 312, see Fig.19 The second film body 312 is fixed to the braided wire 111 through a second connecting member 332. The second connecting member 332 is a flexible member, preferably a suture. The second connecting member 332 can be a plurality of sutures or a continuous line. In this embodiment, the edge of the second film body 312 is fixed to the intersection between the wires of the braided wire 111. It should be noted that the second connecting piece 332 passes through the second film body 312 and the wires or the intersection between the wires 111 in the longitudinal direction (that is, along the axial direction), preferably the intersection between the wires, and the position where the second connecting piece 332 on the braided wire 111 passes through the braided wire 111 (that is, the second connecting piece 332 is wound around the position outside the braided wire 111) is recorded as the winding point. It should be noted that at a single winding point, since the second connecting piece 332 extends axially (that is, longitudinally) and is wound from top to bottom on the intersection between the wires, that is, the extension direction of the part of the second connecting piece 332 located outside the winding point extends axially, and the edge of the second film body 312 extends circumferentially (that is, transversely). Therefore, the second connecting piece 332 can use multiple shorter sutures to connect each intersection between the wires respectively. In addition, since the second film body 312 is subjected to force along the axial direction when bearing blood, the axial connection of the second connecting member 332 will make the bearing capacity of the second film body 312 stronger, which is one of the reasons why the second film body 312 is located at the proximal end of the first film body 311.

[0106] The portion of the second connector 332 located outside the winding point here is similar to the portion of the first connector 331 located outside the threading point mentioned above. The portion of the second connector 332 located outside the winding point refers to a portion of the second connector 332 located outside the braided wire 111 and at a winding point position with the braided wire 111 as the boundary surface.

[0107] In this embodiment, on the overall circumference, there are winding points distributed between two adjacent penetration points (from the perspective of geometric definition, it means that there are winding points distributed in the fan-shaped area enclosed by the plane formed by the two adjacent penetration points and the axis, the same below).

[0108] In another embodiment, a plurality of winding points are distributed between two adjacent threading points in the overall circumferential direction.

[0109] In another embodiment, the penetration points and the winding points are alternately distributed in the overall circumferential direction.

[0110] In another embodiment, in the overall circumferential direction, a plurality of exposed inter-filament intersection points are spaced between two adjacent winding points, and threading points are distributed in the same axial direction of the exposed inter-filament intersection points.

[0111] In another embodiment, the edge of the second film body 312 is fixed to each intersection point between the wires of a certain cross section of the braided wires 111, thereby obtaining a good sealing effect.

[0112] In the present embodiment, in general, the main difference between the first connector 331 and the second connector 332 is that, at a single threading point, the portion of the first connector 331 located outside the braided wire 111 extends circumferentially (the portion of the first connector 331 located outside the threading point extends in the circumferential direction), and at a single winding point, the portion of the second connector 332 located outside the braided wire 111 extends axially (the portion of the second connector 332 located outside the winding point extends in the axial direction).

[0113] It should be noted that since the edges of the first film body 311 and the edges of the second film body 312 are fixed in different ways, if a gap appears in the first film body 311 due to the lateral connection, the gap will also be blocked by the existence of the second film body 312. At the same time, the gap that may be caused by the fixation of the second film body 312 in the axial direction will also be reinforced by the lateral connection of the first film body 311, so that the first film body 311 and the second film body 312 complement each other, further improving the sealing effect. Therefore, in another embodiment, when the extension direction of the part of the first connecting member 331 located outside at least one penetration point is along the circumferential direction and the extension direction of the part of the second connecting member 332 located outside at least one winding point is along the axial direction, the effect of complementary filling of the gap can also be achieved, that is, the sealing effect can still be improved.

[0114] In another embodiment, a portion of the first connecting member 331 located outside the braided wire 111 extends in the axial direction, and a portion of the second connecting member 332 located outside the braided wire 111 extends in the circumferential direction.

[0115] That is to say, the extension direction of the parts of the first connecting member 331 and the second connecting member 332 located on the outside of the braided wire 111 is not necessarily limited to the direction specified in the present embodiment. It is just that the part of the first connecting member 331 located on the outside of the braided wire 111 specified in the present embodiment extends circumferentially, and the part of the second connecting member 332 located on the outside of the braided wire 111 extends axially, which is the optimal choice to achieve the best sealing effect.

[0116] Therefore, further, in order to obtain a good and complementary sealing effect, the extension directions of the part of the first connecting member 331 located outside the braided wire 111 and the part of the second connecting member 332 located outside the braided wire 111 have an angle between 30° and 90°, including 30° and 90°.

[0117] In another embodiment, an auxiliary film body is provided at the proximal end of the first film body 311, and the edges of the auxiliary film body and the second film body 312 are fixed to the braided wire 111 in the same manner, so that the film body in the entire sealing portion 110 is fixed in an alternating manner of longitudinal-lateral-longitudinal connection, so that the edges of the film body are connected to the braided wire 111 in different connection methods, thereby obtaining the best sealing effect.

[0118] Furthermore, in another embodiment, the auxiliary film body is connected to the sealing frame via a third connecting piece, and the extending direction of a portion of the third connecting piece of the auxiliary film body located outside the sealing frame is different from that of the first connecting piece and the second connecting piece.

[0119] It should also be noted that, since the sealing portion 110 may be a tight disk in a natural state, or may be a cylindrical, truncated cone or other shapes, in order to make the connection relationship between the first film body 311, the second film body 312 and the possible auxiliary film body and the braided wire 111 clear, when it comes to the extension direction of the first connecting member 331, the second connecting member 332 and the third connecting member located outside the sealing frame, the sealing portion 110 should be stretched toward both the proximal and distal ends at the same time, as shown in FIG. Fig.14 After judging the status in .

[0120] In this embodiment, the first film body 311 and the second film body 312 are connected by a flexible member 313. Through the design of the flexible member 313, the first film body 311 and the second film body 312 can be deformed as a whole or in a linked manner when the sealing part 110 is deformed. That is, the first film body 311 and the second film body 312 share stress with each other through the flexible member 313, thereby improving the service life and sealing effect of the film body. At the same time, it avoids the volume of the cavity between the first film body 311 and the second film body 312 being too large, that is, it avoids the reserved deformation amount of the two films being too small.

[0121] In another embodiment, preferably, the first film body 311 and the second film body 312 are simultaneously connected to the proximal side of the sealing frame of the sealing portion 110 through the flexible member 313, so that during the transportation process, the middle parts of the first film body 311 and the second film body 312 are always facing the proximal side, thereby limiting or partially limiting the initial release state of the first film body 311 and the second film body 312, so that the volume of the cavity between the first film body 311 and the second film body 312 is smaller, so that the stress is more evenly distributed to the two film bodies; at the same time, the first film body 311 and the second film body 312 are in a pre-pressure or pressure-bearing state after release, so as to avoid the fluid driving the middle parts of the first film body 311 and the second film body 312 to move from the distal end to the proximal end, bringing too much impulse to the position where the first film body 311 is connected to the sealing frame and / or the position where the second film body 312 is connected to the sealing frame.

[0122] In this embodiment, the flexible member 313 can be made of polymer materials, such as PET polyester thread, PP suture thread, PA suture thread, etc., and can also be made of other materials such as rubber, etc. The flexible member 313 passes through the middle area of ​​the first film body 311 and the middle area of ​​the second film body 312, and in this embodiment, the flexible member 313 includes a first end, a second end opposite to the first end, and a connecting section connected between the first end and the second end. The first end and the second end are knotted to form a flexible ring. The node 2131 of the flexible member 313 is located between the first film body 311 and the second film body 312 to prevent the node 2131 from contacting blood to form a relatively large thrombus.

[0123] Furthermore, the distal end of the flexible member 313 passes through the proximal side of the sealing frame of the sealing part 110. Since the middle of the proximal side of the sealing part 110 leaves a matching structure with the steel cable, the distance from the position where the distal end of the flexible member 313 passes through the proximal side of the sealing frame of the sealing part 110 to the axis of the sealing part 110 is between 0.25 and 0.5 times the radius R of the sealing frame of the sealing part 110 (the radius of the sealing frame refers to the radius of the largest cross section of the sealing frame perpendicular to the longitudinal center axis of the occluding device in the naturally unfolded state), that is, 0.25R to 0.5R. In this way, when the sealing part 110 is deformed, the first film body 311 always faces the proximal end of the sealing part 110, so that the first film body 311 can bear and block more blood flow or thrombus. It should be noted that there may be two positions where the flexible member 313 passes through the proximal side of the sealing frame of the sealing part 110. In order to obtain the best effect, it is defined that both positions meet the above definition.

[0124] It should also be noted that the first connecting member 331 is also used in conjunction with the flexible member 313 . The first connecting member 331 is connected horizontally, and a gap is left between two adjacent penetration points, so that the first film body 311 has sufficient margin to accommodate the pulling of the flexible member 313 .

[0125] In another embodiment, the middle part of the second film body 312 is fixed or bound to the middle part of the bottom of the sealing frame of the sealing part 110 by means of stitches or bonding, that is, the middle part of the second film body 312 is always facing the proximal side, thereby limiting or partially limiting the initial release position of the middle part of the second film body 312, so that the second film body 312 is in a pre-pressure or pressure-bearing state after release, thereby preventing the fluid from driving the middle part of the second film body 312 to move from the distal end to the proximal end, thereby bringing too much impulse to the position where the second film body 312 is connected to the sealing frame.

[0126] In another embodiment, the flexible member 313 is wound around the braided wire on the proximal side of the sealing frame at least once to prevent a part of the flexible member from swinging randomly and entering the blood.

[0127] In another embodiment, referring to Fig. 20 , Fig. 20 The method of constricting the proximal end of the sealing frame of the sealing part 110 is shown. The braided wire 111 at the proximal end of the sealing frame of the sealing part 110 is constricted to a constricting member 33. The constricting member 33 can be a hollow bolt head. It should be noted that Fig. 20 This is only to show the way in which the braided wires of the sealing frame are gathered, and does not mean that the cross-sectional shape of the gathering piece 33 is the same as that of the sealing frame. Fig. 20The position where the connection section of the flexible member 313 connects to the sealing frame is located on the outside of the constricting member 33. This is because the proximal end of the braided wire 111 is successively constricted by the constricting member 33 through the distal end of the constricting member 33, the outside of the constricting member 33, and the proximal end 23 of the constricting member, so that the constricting member 33 constricts the braided wire 111 on the outside. When the flexible member 313 is connected to the braided wire 111 of the sealing frame, it is equivalent to passing through the position between the braided wire 111 and the constricting member 33. This has the following effects: on the one hand, the flexible member 313 avoids the position of the constricting member 33, thereby improving the fatigue resistance of the flexible member 313; on the other hand, the constricting member 33 and the braided wire 111 simultaneously realize partial restriction on the flexible member 313 to prevent the flexible member 313 from falling off. At the same time, on the outside of the tie member 33, the flexible member 313 can slide on the braided wire 111 relative to the braided wire 111, and the sliding distance is roughly equal to the axial length L of the tie member, so as to further reserve the deformable amount of the film body and the ability to buffer the impact of external forces. The sliding distance is roughly equal to the axial length L of the tie member, which means that the sliding distance is between 120% L and 80% L, which can be understood as being roughly equal. In another embodiment, the cross-sectional area of ​​the first film body 311 is larger than that of the second film body 312.

[0128] The cross-sectional area in the present application refers to the area after the film body is removed from the sealing frame and spread out flat, or the area after the film body is spread out flat in the sealing frame.

[0129] In another embodiment, the cross-sectional area of ​​the second film body 312 is greater than that of the first film body 311, so that the second film body 312 can serve as the final sealing position to achieve a complete sealing effect, thereby preventing the first film body 311 from leaking due to insufficient area or damage, and thus failing to obtain a good sealing effect due to insufficient area of ​​the second film body 312.

[0130] It should be noted that the related settings of the first film body 311 and the second film body 312 involved in this embodiment only affect the two films. If there are other film bodies, the relationship between the first film body 311 and the second film body 312 will not be affected. Moreover, other film bodies may be interspersed between the first film body 311 and the second film body 312. That is, the first film body 311 and the second film body 312 do not specifically need to be adjacent.

[0131] In addition, the sealing part of the present embodiment is preferably made by weaving, but it does not mean that the sealing part of the present invention can only use a weaving structure of at least one wire, and can also use a mesh structure formed by cutting from the whole, or a mesh structure formed by welding multiple wires. Correspondingly, when the sealing part of the present invention uses a weaving structure of at least one wire, the wire referred to in the present invention refers to the weaving wire, and the intersection point between the wires refers to the overlapping point formed by the overlapping of two wires; when the sealing part of the present invention uses a structure formed by cutting or welding, the wire here refers to the edge of the mesh structure, and the intersection point between the wires refers to the intersection point between multiple edges.

[0132] It should be noted that the technical features of the above-mentioned embodiments can be combined arbitrarily and can also be applied to the various types of left atrial appendage occluders and left atrial appendage occluders with similar structures. In order to make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0133] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A blocking device, comprising a fixing part and a sealing part, wherein the fixing part comprises a plurality of supporting bodies, and the sealing part comprises a plurality of braided wires, characterized in that: The sealing portion comprises a dense mesh structure with axial tensile resistance.

2. The blocking device according to claim 1, characterized in that: The braided wire comprises a proximal segment, a middle segment and a distal segment arranged in sequence, the wire diameter of the middle segment is smaller than the proximal segment and the distal segment, and the middle segment forms or is close to the edge of the sealing portion after braiding.

3. The blocking device according to claim 2, characterized in that: The proximal segment is woven to form a proximal disk surface, and the distal segment is woven to form a distal disk surface. The wire diameter of the distal segment is smaller than the wire diameter of the proximal segment.

4. The blocking device according to claim 1, characterized in that: The fixing part and the sealing part are connected by a connecting part, and the connecting part includes an outer sleeve and an inner sleeve connected to each other. The fixing part is gathered and welded to the distal end of the outer sleeve, and the sealing part is gathered and fixed to the inner sleeve, thereby realizing the connection between the fixing part and the sealing part, and the inner sleeve is flush with the proximal end of the outer sleeve.

5. The blocking device according to claim 1, characterized in that: The total number of strands of the braided wire used in the sealing portion is 144 strands.

6. A testing device, characterized in that: Used for testing the blocking device according to any one of claims 1 to 5, the testing device comprises a hollow main body and a stopper, the inner diameter of the main body is larger than the inner diameter of the stopper, and the stopper is arranged at one end of the main body.

7. The blocking device according to claim 6, characterized in that: The main body and the stopper are integrally formed or detachably connected.

8. The blocking device according to claim 6, characterized in that: In the initial state, the fixing portion passes through the stopper or is located in the stopper, the sealing portion is located in the main body and close to the bottom of the inner cavity of the main body, and when the test starts, the fixing portion moves along the axis of the main body in a direction away from the main body.

9. The blocking device according to claim 6, characterized in that: The inner diameter of the main body is 6 mm to 7 mm larger than the inner diameter of the stopper.

10. The blocking device according to claim 6, characterized in that: The outer diameter of the sealing portion is at least 6 mm greater than the inner diameter of the stopper.

11. A testing method, characterized in that: The testing device according to any one of claims 6 to 10 comprises the following steps: Step S1, placing the sealing part of the blocking device into the main body, and the fixing part passes through the stopper; Step S2, the fixing part moves along the axis of the main body in a direction away from the main body, the sealing part gradually deforms, and then the fixing part continues to move; Step S3, the sealing part is separated from the testing device, and the maximum tensile force displayed by the sensor is recorded as the axial tensile resistance of the sealing part.

12. The blocking method according to claim 11, characterized in that: The convergence part of the fixing part is clamped and fixed by a clamp, and the clamp moves along the axis of the main body in a direction away from the main body to drive the fixing part to move.

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