occlusion device

Abstract

The application relates to a blocking device, which comprises a first part, the first part comprising a plurality of braided wires and a convergence element, one end of the plurality of braided wires being fixed to the convergence element, the first part having at least one disc surface, the convergence element comprising a hollow and sleeved inner sleeve and outer sleeve, at least a part of the disc surface of the proximal end of the first part near the convergence element being perpendicular to the central axis of the convergence element, so that a relatively flat disc surface is formed near the convergence element. The blocking device of the application can form a relatively flat disc surface near the convergence element, that is to say, there is no obvious convex part on the surface of the disc surface, blood flow near the convergence element is prevented from forming a thrombus, and the safety of the blocking device is improved.

Description

[0001] This case is a divisional application with application number 202010808213.2. Technical Field

[0002] This invention relates to the field of interventional medical device technology, and in particular to a sealing device for sealing openings inside the body. Background Technology

[0003] Left atrial appendage occluders, atrial septal defect occluders, and aneurysm occluders are increasingly trusted by doctors and patients due to their superior occlusion structure and the near absence of life-threatening complications after implantation. In these occluders, the sealing disc used to seal the internal opening is typically made of braided wire forming a mesh tube, with both ends secured by plugs.

[0004] Because of the presence of the thrombus head, existing thrombus heads often experience stress at one end of the braided wire, causing the braided wire near the thrombus head to be stretched and bent. This results in the braided wire protruding from the original sealing disc surface at the bend, posing unpredictable risks compared to the original design. This is because when the braided wire near the thrombus head is exposed to the bloodstream, the probability of thrombus formation at that location increases. If the thrombus flows into the brain, it can easily block blood vessels, induce stroke, and endanger human health. Summary of the Invention

[0005] Therefore, it is necessary to provide a new occlusion device to address the problem that thrombi can easily form in existing occlusion devices because the braided wire protrudes from the sealing disc near the embolus head.

[0006] An occlusion device includes a first part comprising a plurality of braided filaments and a gathering member, one end of the plurality of braided filaments being fixed to the gathering member. The first part has at least one disc surface. The gathering member comprises a hollow inner sleeve and an outer sleeve. At least a portion of the disc surface at the proximal end of the first part, near the gathering member, is perpendicular to the central axis of the gathering member, thereby forming a relatively flat disc surface near the gathering member.

[0007] In one embodiment, one end of the gathering member is provided with an end cap connected to the inner sleeve, and one end of the plurality of braided filaments extends from the gap between the end cap and the outer sleeve into the gap between the inner sleeve and the outer sleeve.

[0008] In one embodiment, the end cap and the inner sleeve are integrally formed.

[0009] In one embodiment, the end cap is connected to the proximal end of the inner sleeve.

[0010] In one embodiment, the sealing device further includes a thin film that covers at least a portion of the outer surface of the disk, the film having an opening in its convergence region, and the portion of the film that encloses the opening being received and fixed within the convergence member.

[0011] In one embodiment, the convergence region of the film element is at least partially housed or fixed between the inner sleeve and the outer sleeve.

[0012] In one embodiment, the end cap is provided with a groove, and the portion of the film that surrounds the opening is fixedly clamped in the groove.

[0013] In one embodiment, the inner wall of the inner sleeve is provided with threads or snap-fit ​​fittings.

[0014] In one embodiment, the length of the inner sleeve is greater than the length of the outer sleeve.

[0015] In one embodiment, the proximal end of the inner sleeve and the proximal end of the outer sleeve enclose to form the proximal inlet of the gathering member, and the distal end of the inner sleeve and the distal end of the outer sleeve enclose to form the distal inlet of the gathering member, and one end of the plurality of braided filaments is fixed between the inner sleeve and the outer sleeve after passing through the proximal inlet or the distal inlet of the gathering member.

[0016] In the above-mentioned occlusion device, at least the portion of the disk surface at the proximal end of the first part that is close to the condenser is perpendicular to the central axis of the condenser, thereby forming a relatively flat disk surface near the condenser. In other words, there is no obvious protrusion on the surface of the disk surface, which avoids the formation of blood clots near the condenser and improves the safety of the occlusion device. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of one overall structure of the sealing device in Example 1;

[0018] Figure 2 This is a schematic diagram of one of the structures in the first part of Example 1;

[0019] Figure 3 for Figure 2 Enlarged structural diagram of the middle circular dashed line portion;

[0020] Figure 4 This is a schematic diagram of another structure of the first part in Example 1;

[0021] Figure 5 This is a schematic diagram of another structure of the first part in Example 1;

[0022] Figure 6 for Figure 5 Enlarged structural diagram of the middle circular dashed line portion;

[0023] Figure 7 This is a schematic diagram of another structure of the first part in Example 1;

[0024] Figure 8 for Figure 7 Enlarged structural diagram of the middle circular dashed line portion;

[0025] Figure 9 This is a schematic diagram of another structure of the first part in Example 1;

[0026] Figure 10 for Figure 9 Enlarged structural diagram of the middle circular dashed line portion;

[0027] Figure 11 This is a schematic diagram of the unfolded structure of the thin film component with openings in Example 1;

[0028] Figure 12 This is a schematic diagram of one of the structures in the first part of Example 3;

[0029] Figure 13 for Figure 12 Enlarged structural diagram of the middle circular dashed line portion;

[0030] Figure 14 This is a schematic diagram of the unfolded structure at the proximal end of the first part in Example 5;

[0031] Figure 15 This is a schematic diagram of one of the structures in the first part of Example 6;

[0032] Figure 16 for Figure 15 An enlarged structural diagram of another implementation method for the middle circular dashed line portion;

[0033] Figure 17 for Figure 15 An enlarged structural diagram of another implementation method for the middle circular dashed line portion;

[0034] Figure 18 This is a schematic diagram of one possible structure of the retractor in Example 6;

[0035] Figure 19 This is a schematic diagram of one of the overall structures of the sealing device in Example 10;

[0036] Figure 20A This is a schematic diagram of the structure of the occlusion device implanted into the body tissue and connected to the delivery steel cable in Example 10;

[0037] Figure 20B for Figure 20A A schematic diagram of the longitudinal section of the first part;

[0038] Figure 21A This is a schematic diagram of the structure of the occlusion device implanted into the body tissue and disconnected from the delivery steel cable in Example 10;

[0039] Figure 21B for Figure 21A A schematic diagram of the longitudinal section of the first part;

[0040] Figure 22 This is another structural schematic diagram of the first part in Example 10;

[0041] Figure 23 This is another structural schematic diagram of the first part in Example 10;

[0042] Figure 24 This is another structural schematic diagram of the first part in Example 10;

[0043] Figure 25 This is another structural schematic diagram of the first part in Example 10. Detailed Implementation

[0044] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0045] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0046] In this application, the condenser located near the proximal end is referred to as the proximal condenser, and the condenser located near the distal end is referred to as the distal condenser. Similarly, the disk surface located near the proximal end is referred to as the proximal disk surface, and the disk surface located near the distal end is referred to as the distal disk surface. The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0047] Example 1

[0048] Please refer to Figure 1The illustrated occlusion device 100 includes a first portion 110 located proximally and a second portion 120 located distally. The distal end of the first portion 110 is directly connected to the proximal end of the second portion 120, or the distal end of the first portion 110 and the proximal end of the second portion 120 are indirectly connected via at least one connector 130, which may be rigid or flexible. In some embodiments, the first portion 110 can be used to seal openings or pores in tissues, and the second portion 120 can be used to fix the occlusion device 100 within a cavity of tissue, for example, in the case of sealing the opening of the left atrial appendage. Further, the second portion 120 can also be used to seal openings or pores in tissues. In other embodiments, both the first portion 110 and the second portion 120 can be used to block openings or holes in tissues within the body. For example, the blocking device 100 may be used to block openings in the atrial septum or ventricular septum, or to block patent foramen ovale. In this case, the first portion 110 and the second portion 120 cooperate to fix the blocking device 100 near the opening or hole in the tissue.

[0049] The first part 110 includes multiple braided filaments 111 and two gathering members 112 / 113. Each braided filament 111 has a proximal end and a distal end. The multiple braided filaments 111 can be woven into a mesh-like structure, and after heat setting, they take on a disc-like or columnar shape. Therefore, the first part 110 includes at least one proximal disc surface 114 and one distal disc surface 115. The proximal disc surface 114 of the first part 110 is formed by the mating of the portions of the multiple braided filaments 111 near their proximal ends. The distal disc surface 115 of the first part 110 is formed by the mating of the portions of the multiple braided filaments 111 near their distal ends. The portion where the proximal disc surface 114 and the distal disc surface 115 of the first part 110 connect forms the edge 116 of the first part 110.

[0050] The proximal gathering member 112 of the first part 110 includes a hollow inner sleeve and an outer sleeve, with the proximal ends of multiple braided filaments 111 housed and fixed between the inner sleeve and the outer sleeve, thereby fixing the proximal ends of the multiple braided filaments 111 to the proximal gathering member 112. The distal gathering member 113 of the first part 110 can be a hollow sleeve used to house and fix the distal ends of the multiple braided filaments 111 inside the sleeve, thereby fixing the distal ends of the multiple braided filaments 111 to the distal gathering member 113. In another embodiment, the distal gathering member 113 of the first part 110 can also have the same structure as the proximal gathering member 112 of the first part 110, that is, it includes a hollow inner sleeve and an outer sleeve, used to house and fix the distal ends of the multiple braided filaments 111 between the inner sleeve and the outer sleeve of the distal gathering member 113.

[0051] The specific structure of the second part 120 is not limited, as long as it can fix the sealing device 100 in the cavity of the body tissue after release. For example, the second part 120 can be obtained by laser cutting an alloy tube with shape memory characteristics and then heat-setting it, or it can be obtained by weaving multiple braided wires 111 and then heat-setting them. The distal part of the second part 120 can be closed or open. In this embodiment, the second part 120 includes multiple braided wires 121 and two gathering members 122 / 123, wherein the multiple braided wires 121 can be woven into a columnar braided mesh, the proximal end of the braided mesh is received and fixed by the proximal gathering member 122 of the second part 120, and the distal end of the braided mesh is received and fixed by the distal gathering member 123 of the second part 120.

[0052] The proximal gathering member 122 of the second part 120 may include a hollow inner sleeve and an outer sleeve, which are used to receive and fix the proximal ends of the multiple braided filaments 121 of the second part 120 between the inner sleeve and the outer sleeve. In another embodiment, the proximal gathering member 122 of the second part 120 may also be a hollow sleeve, which is used to receive and fix the proximal ends of the multiple braided filaments 121 of the second part 120 inside the sleeve.

[0053] The distal gathering member 123 of the second part 120 can also be a hollow sleeve, used to receive and fix the distal ends of the multiple braided filaments 121 of the second part 120 inside the sleeve. In another embodiment, the distal gathering member 123 of the second part 120 can also have the same structure as the proximal gathering member 112 of the first part 110, that is, it includes a hollow inner sleeve and an outer sleeve, used to receive and fix the distal ends of the multiple braided filaments 121 of the second part 120 between the inner sleeve and the outer sleeve.

[0054] In other embodiments, when the first part 110 and the second part 120 are integrally formed, the distal end of the first part 110 may not be provided with a distal end retractor 113, and the proximal end of the second part 120 may not be provided with a proximal end retractor 122.

[0055] The sealing device 100 also includes a diaphragm element, which may be disposed on the first portion 110 and / or the second portion 120. When the diaphragm element is disposed on the first portion 110, the diaphragm element 117 at least covers the outer surface of the proximal disk surface 114 of the first portion 110, and the convergence region 118 of the diaphragm element 117 is at least partially fixed within the proximal convergence member 112 of the first portion 110, thereby ensuring that the proximal end of the first portion 110 has sufficiently good sealing performance, and at the same time, the convergence region 118 of the diaphragm element 117 is firmly fixed by the proximal convergence member 112. In other embodiments, the diaphragm element 117 covers a portion of the outer surface of the proximal disk surface 114 of the first portion 110 to selectively enhance the sealing performance of local areas of the proximal disk surface 114 as needed. In other embodiments, the diaphragm element 117 on the first portion 110 may further cover the edge 116 of the first portion 110. Furthermore, in other embodiments, the film element 117 on the first portion 110 may also cover the distal disk surface 115 of the first portion 110, that is, the film element 117 covers the proximal disk surface 114, edge 116, and distal disk surface 115 of the first portion 110. The convergence region 118 of the film element 117 refers to the portion of the film element 117 located near the convergent member, which may be located at the center or other positions of the film element 117; when the film element 117 is fixed by the proximal convergent member 112 or the distal convergent member 123, the convergence region 118 of the film element 117 may refer to the portion of the film element 117 close to the corresponding proximal convergent member 112 or distal convergent member 123. Similarly, the convergence region 125 of the film element 124 on the second portion 120 can be defined.

[0056] The film component 117 can be made of PET film or PTFE film, thus not only having good sealing performance, but also promoting the adhesion of the endothelium on the film component 117 under the impact of blood flow, thereby further improving the sealing performance.

[0057] like Figures 1 to 3As shown, a thin film 117 covers the proximal disc surface 114 and edge 116 of the first portion 110. The thin film 117 can be one layer or multiple layers. A portion of the convergence region 118 of the thin film 117 is fixed within the proximal convergence member 112 of the first portion 110. Specifically, it can be fixed by being clamped between the inner sleeve 1121 and the outer sleeve 1122 of the proximal convergence member 112, or it can be snapped onto the inner sleeve 1121 and the outer sleeve 1122 and relatively fixed after the inner sleeve 1121 and the outer sleeve 1122 are connected together. Other portions of the thin film 117 can be sewn onto the proximal disc surface 114 of the first portion 110 by sutures or bonded to the proximal disc surface 114 of the first portion 110 by adhesive. The edge of the thin film 117 covers the edge 116 of the first portion 110, which can reduce scratching and other damage to the tissues inside the body caused by the edge 116 of the first portion 110. The edge of the film component 117 can be fixed by sewing it to the braided wires 111 at the edge 116 with a suture thread, or by bonding it with an adhesive. The proximal ends of the multiple braided wires 111 on the first part 110 are fixed between the inner sleeve 1121 and the outer sleeve 1122 of the proximal end gathering component 112. The fixing method can be that the inner sleeve 1121 and the outer sleeve 1122 are clamped together, or the proximal ends of the multiple braided wires 111 are fixed to the distal end of the outer sleeve 1122 by welding or other methods. The fixing method is not limited.

[0058] The membrane element 117 can be a complete circular membrane without any obvious openings. After the membrane element 117 is sandwiched between the inner sleeve 1121 and the outer sleeve 1122 of the proximal constrictor 112, the distal opening 1123 of the inner sleeve 1121 is covered by the central part of the membrane element 117, thereby blocking the distal opening 1123 of the inner sleeve 1121 to prevent blood from flowing into the interior of the first part 110 through the inner sleeve 1121, thus improving the sealing performance of the sealing device 100.

[0059] Furthermore, the inner wall of the inner sleeve 1121 of the proximal end of the first part 110 is provided with a thread 1124 or a snap-fit, which can cooperate with the distal end of the conveying steel cable to achieve a detachable connection. This allows the proximal end of the first part 110 112 to be used to convey the sealing device 100 when connected to the conveying steel cable, and to completely release the sealing device 100 and retrieve the conveying steel cable when disconnected. In other embodiments, the inner wall of the inner sleeve 1121 of the 110 110 may not be provided with a thread 1124 or a snap-fit.

[0060] Furthermore, the inner sleeve 1121 of the proximal end convergence member 112 of the first part 110 is provided with a radially extending limiting member 1125 or a limiting member 1125 that forms an angle with the central axis of the inner sleeve 1121. This limiting member can be used to restrict the depth of the transmission cable when it is connected to the proximal end convergence member 112, preventing the distal end of the transmission cable from poking the film member 117 located on the distal end face of the proximal end convergence member 112. This limiting member can also be used to fix the film member 117 to the proximal end convergence member 112, thereby further enhancing the stability of the film member 117 within the proximal end convergence member 112. In this embodiment, the limiting member 1125 is a pin that passes through the wall of the inner sleeve 1121 and the wall of the outer sleeve 1122 of the proximal constrictor 112. The inner sleeve 1121 has two opposing through holes, and the outer sleeve 1122 also has two opposing through holes. One end of the pin passes through the through hole of the outer sleeve 1122, the through hole of the inner sleeve 1121, the through hole of the inner sleeve 1121, and the through hole of the outer sleeve 1122 in sequence from the outside to the inside. Finally, both ends of the pin are respectively received and fixed in the two through holes of the outer sleeve 1122. In other embodiments, the limiting member 1125 may also be other rod-shaped components, and both ends of the limiting member 1125 may extend outward from the wall of the outer sleeve 1122. Further, after extending out of the wall of the outer sleeve 1122, the two ends of the limiting member 1125 are constrained by shape to restrict the radial movement of the limiting member 1125. For example, the two ends of the limiting member 1125 may be spherical or other shaped protrusions, as long as the outer diameter of the protrusion in the axial direction is greater than the diameter of the through hole on the wall of the outer sleeve 1122 for receiving the limiting member 1125. In other embodiments, the limiting member 1125 only penetrates the wall of the inner sleeve 1121, and both ends of the limiting member 1125 are respectively received and fixed in the two through holes of the inner sleeve 1121. In other embodiments, the limiting member 1125 may not be provided inside the proximal constrictor 112.

[0061] In this embodiment, at least the portion 1141 of the proximal disc surface 114 of the first part 110 near the proximal constrictor 112 is perpendicular to the central axis of the proximal constrictor 112, thereby forming a relatively flat disc surface near the proximal constrictor 112 to avoid the risk of thrombus formation near the proximal constrictor 112 and improve safety. Here, a flat disc surface means that there are no obviously protruding parts on the surface of the disc surface; even if there are several protruding parts, the height of these protruding parts relative to other parts is less than or equal to 2 mm. In other embodiments, such as... Figure 4 As shown, at least a portion 1142 of the proximal disk surface 114 of the first portion 110 that is close to the proximal condenser 112 may be configured not to be perpendicular to the central axis of the proximal condenser 112.

[0062] Furthermore, in other embodiments, such as Figures 4 to 6As shown, the proximal end of the proximal end of the condenser 112 is provided with an end cap 1126 connected to the inner sleeve 1121. The condenser region 118 of the film 117 is at least partially received or fixed between the end cap 1126 and the outer sleeve 1122, thereby further securing the film 117 within the proximal end of the condenser 112. The proximal ends of the multiple braided filaments 111 on the first part 110 extend from the gap between the end cap 1126 and the outer sleeve 1122 into the gap between the inner sleeve 1121 and the outer sleeve 1122, until they extend to the distal end of the outer sleeve 1122, and are then fixed to the distal end of the proximal end of the condenser 112 by welding or other means. Specifically, as one implementation, it can be fixed between the distal end of the outer sleeve 1122 and the distal end of the inner sleeve 1121. In other embodiments, the distal end of the proximal constrictor 112 may also be provided with an end cap 1126 connected to the outer sleeve 1122 or the inner sleeve 1121, so as to further securely fix the film 117 inside the proximal constrictor 112, and also to seal the opening at the distal end of the proximal constrictor 112 to improve the sealing performance.

[0063] exist Figure 5 and Figure 6 In the embodiment shown, the convergence region 118 of the thin film 117 is provided as follows: Figure 11 The opening 1171 shown is partially enclosed and fixed within the proximal constrictor 112 by the film member 117 surrounding the opening 1171. Specifically, the portion of the film member 117 surrounding the opening 1171 extends from the gap between the end cap 1126 and the outer sleeve 1122 into the space between the inner sleeve 1121 and the outer sleeve 1122, and is then clamped between the inner sleeve 1121 and the outer sleeve 1122 in an annular or tubular shape along with a portion of the multiple braided filaments 111. This film member 117 can be used when it is necessary for the distal opening 1123 of the proximal constrictor 112 to remain open, such as when it is necessary to transport substances or components distally through the distal opening 1123. In other embodiments, the end cap 1126 may be provided with a groove, and the portion of the film member 117 surrounding the opening 1171 may be fixedly clamped within the groove of the end cap 1126, and the specific method is not limited. In other embodiments, the proximal constrictor 112 may not have a limiting member 1125 or an end cap 1126, and the inner sleeve 1121 may not have a thread 1124 or a snap-fit ​​member.

[0064] The proximal ends of the inner sleeve 1121 and the outer sleeve 1122 enclose each other to form the proximal inlet of the proximal gathering member 112, and the distal ends of the inner sleeve 1121 and the outer sleeve 1122 enclose each other to form the distal inlet of the proximal gathering member 112. The proximal ends of the multiple braided filaments 111 of the first portion 110, after passing through the proximal or distal inlet of the proximal gathering member 112, are received or fixed between the inner sleeve 1121 and the outer sleeve 1122. Specifically, when the proximal ends of the multiple braided filaments 111 of the first portion 110 are received and fixed through the proximal inlet of the proximal gathering member 112, such as... Figure 3 and Figure 6 As shown, the convergence region 118 of the film member 117 is at least partially secured between the inner sleeve 1121 and the outer sleeve 1122 via the proximal inlet 1127 of the proximal convergence member 112. When the proximal ends of the multiple braided filaments 111 of the first portion 110 are received and secured through the distal inlet 1128 of the proximal convergence member 112, as... Figure 7 and Figure 8 As shown, the convergence region 118 of the film member 117 is at least partially received or secured between the inner sleeve 1121 and the outer sleeve 1122 via the distal inlet 1128 of the proximal convergence member 112. In other embodiments, when the proximal ends of the plurality of braided filaments 111 of the first portion 110 are received and secured via the distal inlet 1128 of the proximal convergence member 112, as... Figure 9 and Figure 10 As shown, the convergence region 118 of the film member 117 is at least partially received or fixed between the inner sleeve 1121 and the outer sleeve 1122 via the proximal inlet 1127 of the proximal convergence member 112.

[0065] In other embodiments, the interior of the first portion 110 is further provided with at least one flow-blocking membrane to prevent blood from flowing from the proximal disc surface 114 of the first portion 110 into the interior of the first portion 110, thereby further improving the sealing performance of the first portion 110.

[0066] Example 2

[0067] The parts of the occlusion device in Embodiment 2 that are the same as those in Embodiment 1 will not be described again here. The main difference between the two is that the proximal condenser 112 or the distal condenser 113 of the first part 110 described in Embodiment 1 can also be used in the second part 120.

[0068] Specifically, with Figure 1The structure shown is approximate, with the film element 124 of the second portion 120 covering the outer surface and edge 127 of the proximal disk surface 126 of the second portion 120, and the convergence region 125 of the film element 124 being at least partially fixed within the proximal convergence element 122 of the second portion 120. The edge 127 of the second portion 120 is the side portion between the proximal disk surface 126 and the distal disk surface 128 of the second portion 120. Further, in other embodiments, the film element 124 on the second portion 120 may further cover the distal disk surface 128 of the second portion 120, that is, the film element 124 covers the proximal disk surface 126, the edge 127, and the distal disk surface 128 of the second portion 120. In other embodiments, the film element 124 of the second portion 120 covers only the outer surface of the proximal disk surface 126 or the outer surface of the distal disk surface 128 of the second portion 120, or the outer surface of the distal disk surface 128 and the edge 127. In other embodiments, the film 124 may cover a portion of the outer surface of the proximal disc 126 or the distal disc 128 to selectively enhance the sealing of local areas of the proximal disc 126 or the distal disc 128 as needed. Based on this, the various specific structures of the proximal gathering member 112 provided on the first part 110 in Embodiment 1, as well as the various specific methods for accommodating and fixing the proximal ends of multiple braided filaments 111 and the gathering region 118 of the film 117, are also applicable to the proximal gathering member 122 on the second part 120, and will not be described further here.

[0069] Example 3

[0070] The parts of the sealing device in Embodiment 3 that are the same as those in Embodiment 1 will not be described again here. The main difference between the two is that the proximal converging member 112 described in Embodiment 1 can be set at the far end of the first part 110 as the distal converging member 113. The structure, the way of cooperating with the film member 117, and the way of fixing in the converging member are the same or similar.

[0071] Specifically, the film element 117 of the first portion 110 at least covers a portion of the outer surface of the distal disk surface 115 of the first portion 110, and the convergence region 118 of the film element 117 is at least partially fixed within the distal convergence element 113 of the first portion 110. In other embodiments, the film element 117 on the first portion 110 further covers the edge 116 of the first portion 110. Further, in this embodiment, as... Figure 12 As shown, the film element 117 on the first part 110 can also cover the proximal disk surface 114 of the first part 110, that is, the film element 117 covers the distal disk surface 115, the edge 116 and the proximal disk surface 114 of the first part 110.

[0072] In some embodiments, combined Figure 12 and Figure 13As shown, the distal gathering member 113 of the first part 110 includes an inner sleeve 1131 and an outer sleeve 1132 extending from the inside to the outside. The proximal ends of the inner sleeve 1131 and the outer sleeve 1132 enclose to form a proximal inlet 1133 of the distal gathering member 113, and the distal ends of the inner sleeve 1131 and the outer sleeve 1132 enclose to form a distal inlet 1134 of the distal gathering member 113. The distal ends of the multiple braided filaments 111 of the first part 110 are received or fixed between the inner sleeve 1131 and the outer sleeve 1122 after passing through the distal inlet 1134 of the distal gathering member 113. In other embodiments, the distal ends of the multiple braided filaments 111 of the first part 110 are received or fixed between the inner sleeve 1131 and the outer sleeve 1122 after passing through the proximal inlet 1133 of the distal gathering member 113.

[0073] Specifically, when the distal ends of the multiple braided filaments 111 of the first portion 110 are received and fixed through the proximal inlet 1133 of the distal gathering member 113, the gathering region 118 of the film member 117 is at least partially received or fixed between the inner sleeve 1131 and the outer sleeve 1122 via the proximal inlet 1133 or the distal inlet 1134 of the distal gathering member 113. When the distal ends of the multiple braided filaments 111 of the first portion 110 are received and fixed through the distal inlet 1134 of the distal gathering member 113, the gathering region 118 of the film member 117 is at least partially received or fixed between the inner sleeve 1131 and the outer sleeve 1122 via the distal inlet 1134 of the distal gathering member 113.

[0074] Example 4

[0075] The parts of the blocking device in Embodiment 4 that are the same as those in Embodiment 3 will not be described again here. The main difference between the two is that the distal convergent member 113 of the first part 110 described in Embodiment 3 can also be used for the distal convergent member 123 of the second part 120.

[0076] Specifically, the thin film 124 of the second portion 120 at least covers a portion of the outer surface of the distal disk 128 of the second portion 120, and the convergence region 125 of the thin film 124 is at least partially fixed within the distal convergence member 123 of the second portion 120. Figure 1In the illustrated embodiment, the film element 124 on the second portion 120 may further cover the edge 127 of the second portion 120, that is, the side portion between the proximal disk surface 126 and the distal disk surface 128 of the second portion 120. Further, in other embodiments, the film element 124 on the second portion 120 may also cover the proximal disk surface 126 of the second portion 120, that is, the film element 124 covers the distal disk surface 128, the edge 127, and the proximal disk surface 126 of the second portion 120. Based on this, the various specific structures of the distal gathering member 113 provided on the first portion 110 in Embodiment 3, as well as the various specific methods of accommodating and fixing the distal ends of multiple braided filaments and the gathering region 118 of the film element 117, are also applicable to the distal gathering member 123 on the second portion 120, and will not be described again here.

[0077] Example 5

[0078] The parts of the sealing device in Example 5 that are the same as those in Examples 1 to 4 will not be described again here. The main difference is that, for example... Figure 14 As shown, the first part 110 also includes an extension 119 located at the edge 116 of the first part 110. The film 117 on the first part 110 also covers the extension 119, and the extension 119 radially expands the film 117 after being unfolded. In this embodiment, the extension 119 consists of multiple semi-circular filaments disposed at the edge 116 of the first part 110, with both ends of the filaments fixed to the edge 116 of the first part 110. The multiple filaments can be evenly distributed along the edge 116 of the first part 110. Further, adjacent filaments can be spaced apart by a certain distance or abut against each other. As one embodiment, the filaments can be formed by a portion of multiple braided filaments 111 woven into the first part 110 protruding outward from the edge 116 of the first part 110. In other embodiments, the filaments can be separate components, with both ends of which can be fixed at appropriate positions on the edge 116 of the woven first part 110, and can be semi-circular. The extension 119 may also have other shapes or structures, as long as it can unfold and radially outwardly expand the film 117 when the first part 110 is released, so that the film 117 unfolds flat on the outer surface of the first part 110, thus avoiding wrinkles on the disc surface that could easily lead to thrombosis.

[0079] In other embodiments, the aforementioned extension 119 may also be provided along the edge 127 of the second part 120, with the same structure and function, which will not be described again here.

[0080] Example 6

[0081] The parts of the sealing device in Embodiment 6 that are the same as those in Embodiment 1 will not be described again here. The main difference between the two is that the gathering member in Embodiment 6 includes an inner sleeve, a middle sleeve, and an outer sleeve, all of which are hollow and are sequentially arranged from the inside out. The gathering member located near the first part 110 is called the proximal gathering member 112, and the gathering member located far from the first part 110 is called the distal gathering member 123. The proximal ends of the multiple braided filaments 111 of the first part 110 and the gathering region 118 of the film member 117 are at least partially housed and fixed within the proximal gathering member 112 of the first part 110.

[0082] After the proximal ends of the multiple braided filaments 111 of the first part 110 are fixed between the outer sleeve and the intermediate sleeve, the outer sleeve and the intermediate sleeve are also fixed together. The inner sleeve and the outer sleeve, or the inner sleeve and the intermediate sleeve, can be directly or indirectly fixed together through various methods such as protrusions and grooves, or protrusions and through holes, thereby forming a relatively stable proximal end-gathering member 112. Specific structures and mating methods are not limited and will not be listed here.

[0083] The distal gathering member 113 of the first part 110 can be a hollow sleeve for receiving and fixing the distal ends of multiple braided filaments 111 inside the sleeve. In another embodiment, the distal gathering member 113 of the first part 110 can also have the same structure as the proximal gathering member 112 of the first part 110, that is, it includes an inner sleeve, a middle sleeve and an outer sleeve that are hollow and arranged sequentially from the inside to the outside, for receiving and fixing the distal ends of multiple braided filaments 111 between the inner sleeve and the middle sleeve, or between the middle sleeve and the outer sleeve of the distal gathering member 113.

[0084] like Figure 15As shown, a thin film 117 is covered on the proximal disc surface 114 and edge 116 of the first part 110. The thin film 117 can be one or more layers. A portion of the constriction region 118 of the thin film 117 is fixed within the proximal constriction member 112 of the first part 110. Specifically, it is clamped between the inner sleeve 2121 and the intermediate sleeve 2122 of the proximal constriction member 112, thereby ensuring sufficient sealing at the proximal end of the first part 110 and simultaneously securing the constriction region 118 of the thin film 117 firmly through the proximal constriction member 112. Other portions of the thin film 117 can be sewn onto the proximal disc surface 114 of the first part 110 by sutures or bonded to the proximal disc surface 114 of the first part 110 by adhesive. The edge of the thin film 117 covers the edge 116 of the first part 110, reducing damage to tissues caused by the edge 116 of the first part 110. The edge of the film component 117 can be fixed by sewing it to the braided wires 111 at the edge 116 with a suture thread, or by bonding it with an adhesive. The proximal ends of the multiple braided wires 111 on the first part 110 are fixed between the intermediate sleeve 2122 and the outer sleeve 2123 of the proximal end gathering component 112. The fixing method can be by clamping the intermediate sleeve 2122 and the outer sleeve 2123, or by welding the proximal ends of the multiple braided wires 111 between the intermediate sleeve 2122 and the outer sleeve 2123, or by welding the proximal ends of the multiple braided wires 111 to the distal end of the outer sleeve 2123. The fixing method is not limited.

[0085] The membrane component 117 can be a complete circular membrane without any obvious openings 1171. After the membrane component 117 is sandwiched between the inner sleeve 2121 and the intermediate sleeve 2122 of the proximal constrictor 112, the distal opening 2124 of the inner sleeve 2121 is covered by the central part of the membrane component 117, thereby blocking the distal opening 2124 of the inner sleeve 2121 to prevent blood from flowing into the interior of the first part 110 through the inner sleeve 2121, thus improving the sealing performance of the sealing device.

[0086] Furthermore, the inner wall of the inner sleeve 2121 of the proximal end retractor 112 of the first part 110 is provided with threads 1124 or snap-fit ​​components, which can cooperate with the distal end of the transport cable to achieve a detachable connection. This allows the proximal end retractor 112 of the first part 110 to be used to transport the sealing device when connected to the transport cable, and to completely release the sealing device and retrieve the transport cable when the connection is disconnected. In other embodiments, the inner wall of the inner sleeve 2121 of the retractor may not be provided with threads 1124 or snap-fit ​​components.

[0087] In this embodiment, the portion of the proximal disc surface 114 of the first portion 110 near the proximal constrictor 112 is approximately conical around the outer sleeve 2123, and therefore this portion is not perpendicular to the central axis of the proximal constrictor 112. In other embodiments, at least the portion of the proximal disc surface 114 of the first portion 110 near the proximal constrictor 112 is perpendicular to the central axis of the proximal constrictor 112, thereby forming a relatively flat disc surface near the proximal constrictor 112 to avoid the risk of thrombus formation near the proximal constrictor 112 and improve safety.

[0088] The proximal end of the intermediate sleeve 2122 is flush with the proximal end of the inner sleeve 2121 and the proximal end of the outer sleeve 2123, respectively. The distal end of the outer sleeve 2123 is flush with the distal end of the inner sleeve 2121. The length of the intermediate sleeve 2122 is less than the length of the outer sleeve 2123 and the inner sleeve 2121. The proximal ends of multiple braided wires 111 are accommodated and fixed between the intermediate sleeve 2122 and the outer sleeve 2123. The specific location and fixing method of the fixing point are not limited.

[0089] Furthermore, the inner sleeve 2121 of the proximal convergence member 112 of the first part 110 is provided with a radially extending limiting member 1125 or a limiting member 1125 that forms an angle with the central axis of the inner sleeve 2121. The two ends of the limiting member 1125 penetrate the tube wall of the inner sleeve 2121 to fix the limiting member 1125 to the inner sleeve 2121. The limiting member 1125 can be used to limit the depth of the transmission cable into the inner sleeve 2121 when it is connected to the proximal convergence member 112, preventing the distal end of the transmission cable from poking the membrane member 117 located on the distal end face of the proximal convergence member 112. It can also be used to fix the membrane member 117 to the proximal convergence member 112 to further enhance the stability of the membrane member 117 within the proximal convergence member 112. The two ends of the limiting member 1125 further penetrate the wall of the outer sleeve 2123 to fix the limiting member 1125 and the outer sleeve 2123 together, thereby connecting and fixing the inner sleeve 2121 and the outer sleeve 2123.

[0090] In this embodiment, the limiting member 1125 is a pin that passes through the wall of the inner sleeve 2121 and the wall of the outer sleeve 2123 of the proximal constrictor 112. The inner sleeve 2121 has two opposing through holes, and the outer sleeve 2123 also has two opposing through holes. One end of the pin passes through the through hole 2125 of the outer sleeve 2123, the through hole 2126 of the inner sleeve 2121, the through hole 2127 of the inner sleeve 2121, and the through hole 2128 of the outer sleeve 2123 in sequence from the outside to the inside. Finally, both ends of the pin are received and fixed in the through holes 2125 and 2128 of the outer sleeve 2123, respectively. In other embodiments, the limiting member 1125 may also be other rod-shaped components, and both ends of the limiting member 1125 may extend outward from the wall of the outer sleeve 2123. Further, after extending out of the wall of the outer sleeve 2123, the two ends of the limiting member 1125 are constrained by shape to restrict the radial movement of the limiting member 1125. For example, the two ends of the limiting member 1125 may be spherical or other shaped protrusions, as long as the outer diameter of the protrusion in the axial direction is greater than the diameter of the through hole on the wall of the outer sleeve 2123 used to accommodate the limiting member 1125. In other embodiments, the limiting member 1125 may not be provided within the proximal constrictor 112.

[0091] In other embodiments, the limiting member 1125 penetrates only the wall of the inner sleeve 2121, and both ends of the limiting member 1125 are respectively received and fixed within the through holes 2126 and 2127 of the inner sleeve 2121. Further, in one embodiment, as... Figure 16 As shown, the limiting member 1125 only penetrates the wall of the inner sleeve 2121, and the two ends of the limiting member 1125 extend from the through holes 2126 and 2127 of the inner sleeve 2121 respectively, and are formed into ball heads by means of heat fusion, thereby clamping the inner sleeve 2121 between the two ball heads. At the same time, since the two ends of the limiting member 1125 pass through the film member 117 respectively, the part of the film member 117 near the limiting member 1125 is also relatively fixed.

[0092] In other embodiments, the proximal end of the proximal convergence member 112 is provided with an end cap 1126 connected to the inner sleeve 2121, and the convergence region 118 of the film member 117 is at least partially received or fixed between the end cap 1126 and the outer sleeve 2123, thereby further securing the film member 117 within the proximal convergence member 112. As one implementation, such as... Figure 16As shown, the length of the outer sleeve 2123 is the same as the length of the middle sleeve 2122, and the length of the inner sleeve 2121 is greater than the length of both the outer sleeve 2123 and the middle sleeve 2122. The proximal ends of multiple braided filaments 111 on the first part 110 extend from the gap between the end cap 1126 and the outer sleeve 2123 into the gap between the middle sleeve 2122 and the outer sleeve 2123, until they reach the distal end of the middle sleeve 2122. They are then fixed to the distal ends of the middle sleeve 2122 and the outer sleeve 2123 by welding or other methods. In other embodiments, the end cap 1126 may further press the film element 117 against the outer sleeve 2123 and / or the middle sleeve 2122. In other embodiments, the distal end of the proximal constrictor 112 may also be provided with an end cap 1126 connected to the outer sleeve 2123 or the inner sleeve 2121, so as to further securely fix the film 117 inside the proximal constrictor 112, and also to seal the opening at the distal end of the proximal constrictor 112 to improve the sealing performance.

[0093] In other embodiments, the convergence region 118 of the thin film 117 is provided as follows: Figure 11 The opening 1171 shown is partially enclosed and fixed within the proximal constrictor 112 by the film member 117 surrounding the opening 1171. Specifically, as shown... Figure 17 As shown, the portion of the film element 117 that encloses the opening 1171 extends into the gap between the end cap 1126 and the outer sleeve 2123, and is fixed between the outer sleeve 2123, the intermediate sleeve 2122, and the end cap 1126. In other embodiments, the portion of the film element 117 that encloses the opening 1171 may further extend between the inner sleeve 2121 and the intermediate sleeve 2122, or between the intermediate sleeve 2122 and the outer sleeve 2123, and be clamped or snapped between adjacent sleeves in an annular or tubular shape, as long as it does not affect the proximal fixation of the multiple braided filaments 111 within the proximal gathering member 112. This film element 117 can be used when it is necessary for the distal opening 2124 of the proximal gathering member 112 to remain open. In other embodiments, the proximal constrictor 112 may not have a limiting member 1125 or an end cap 1126, and the inner sleeve 2121 may not have a thread 1124 or a snap-fit ​​member.

[0094] like Figure 18As shown, the proximal end of the outer sleeve 2123 and the proximal end of the intermediate sleeve 2122 enclose to form the outer proximal inlet 221 of the proximal constrictor 112; the proximal end of the intermediate sleeve 2122 and the proximal end of the inner sleeve 2121 enclose to form the inner proximal inlet 222 of the proximal constrictor 112; the distal end of the outer sleeve 2123 and the distal end of the intermediate sleeve 2122 enclose to form the outer distal inlet 223 of the proximal constrictor 112; and the distal end of the intermediate sleeve 2122 and the distal end of the inner sleeve 2121 enclose to form the inner distal inlet 224 of the proximal constrictor 112. Figures 15 to 17 As shown, the proximal ends of the multiple braided filaments 111 of the first portion 110 are received or fixed between the outer sleeve 2123 and the intermediate sleeve 2122. In other embodiments, the proximal ends of the multiple braided filaments 111 of the first portion 110 are received or fixed between the intermediate sleeve 2122 and the inner sleeve 2121. Specifically, the proximal ends of the multiple braided filaments 111 of the first portion 110 are received or fixed within the proximal gathering member 112 after passing through one of the outer proximal inlet 221, the outer distal inlet 223, and the inner distal inlet 224 of the proximal gathering member 112.

[0095] In some embodiments, when the proximal ends of the multiple braided filaments 111 of the first portion 110 are received and secured through the outer proximal inlet 221 of the proximal end gathering member 112, the gathering region 118 of the film member 117 is at least partially secured between the inner sleeve 2121 and the intermediate sleeve 2122 via the inner proximal inlet 222 of the proximal end gathering member 112, or at least partially secured between the outer sleeve 2123, the intermediate sleeve 2122, and the end cap 1126. When the proximal ends of the multiple braided filaments 111 of the first portion 110 are received and secured through the outer distal inlet 223 of the proximal end gathering member 112, the gathering region 118 of the film member 117 is at least partially received or secured between two adjacent sleeves via the outer proximal inlet 221 or the inner proximal inlet 222 of the proximal end gathering member 112, or at least partially secured between the outer sleeve 2123, the intermediate sleeve 2122, and the end cap 1126. When the proximal ends of the multiple braided filaments 111 of the first part 110 are received and fixed through the inner distal inlet 224 of the proximal end gathering member 112, the gathering region 118 of the film member 117 is at least partially received or fixed between the inner sleeve 2121 and the outer sleeve 2123, or at least partially fixed between the outer sleeve 2123, the intermediate sleeve 2122 and the end cap 1126, via any one of the outer proximal inlet 221, the inner proximal inlet 222 and the outer distal inlet 223 of the proximal end gathering member 112.

[0096] In other embodiments, the interior of the first portion 110 is further provided with at least one flow-blocking membrane to prevent blood from flowing from the proximal disc surface 114 of the first portion 110 into the interior of the first portion 110, thereby further improving the sealing performance of the first portion 110.

[0097] Example 7

[0098] The parts of the occlusion device in Embodiment 7 that are the same as those in Embodiment 6 will not be described again here. The main difference between the two is that the proximal condenser 112 or the distal condenser 113 of the first part 110 described in Embodiment 6 can also be used for the proximal condenser 122 or the distal condenser 123 of the second part 120.

[0099] Specifically, the film element 124 of the second portion 120 at least covers a portion of the outer surface of the proximal disk surface 126 of the second portion 120, and the convergence region 125 of the film element 124 is at least partially fixed within the proximal convergence element 122 of the second portion 120. In other embodiments, the film element 124 on the second portion 120 may further cover the edge 127 of the second portion 120, that is, the side portion between the proximal disk surface 126 and the distal disk surface 128 of the second portion 120. Further, in other embodiments, the film element 124 on the second portion 120 may also cover the distal disk surface 128 of the second portion 120, that is, the film element 124 covers the proximal disk surface 126, the edge 127, and the distal disk surface 128 of the second portion 120. Based on this, the various specific structures of the proximal gathering member 112 provided on the first part 110 in Embodiment 6, as well as the various specific methods of accommodating and fixing the proximal ends of multiple braided filaments 111 and the gathering region 118 of the film member 117, are also applicable to the proximal gathering member 122 on the second part 120, and will not be described again here.

[0100] Example 8

[0101] The parts of the sealing device in Embodiment 8 that are the same as those in Embodiment 6 will not be described again here. The main difference between the two is that the proximal converging member 112 described in Embodiment 6 can be disposed at the far end of the first part 110 as the distal converging member 113. The structure, the way of cooperating with the film member 117, and the way of fixing in the converging member are the same or similar.

[0102] Specifically, the film element 117 of the first portion 110 at least covers a portion of the outer surface of the distal disk surface 115 of the first portion 110, and the convergence region 118 of the film element 117 is at least partially fixed within the distal convergence element 113 of the first portion 110. In other embodiments, the film element 117 on the first portion 110 may further cover the edge 116 of the first portion 110. Furthermore, the film element 117 on the first portion 110 may also cover the proximal disk surface 114 of the first portion 110, that is, the film element 117 covers the distal disk surface 115, the edge 116, and the proximal disk surface 114 of the first portion 110.

[0103] like Figure 18 As shown, the distal converging member 113 of the first part 110 includes an inner sleeve 2121, an intermediate sleeve 2122, and an outer sleeve 2123, all hollow and sequentially fitted from the inside out. The proximal end of the outer sleeve 2123 and the proximal end of the intermediate sleeve 2122 enclose to form the outer proximal inlet 221 of the distal converging member 113; the proximal end of the intermediate sleeve 2122 and the proximal end of the inner sleeve 2121 enclose to form the inner proximal inlet 222 of the distal converging member 113; the distal end of the outer sleeve 2123 and the distal end of the intermediate sleeve 2122 enclose to form the outer distal inlet 223 of the distal converging member 113; and the distal end of the intermediate sleeve 2122 and the distal end of the inner sleeve 2121 enclose to form the inner distal inlet 224 of the distal converging member 113. The distal ends of the multiple braided filaments 111 of the first part 110 are received or fixed in the distal constrictor 113 after passing through one of the outer proximal inlet 221, the inner proximal inlet 222, and the outer distal inlet 223.

[0104] In some embodiments, when the distal ends of the plurality of braided filaments 111 of the first portion 110 are received and secured through the outer proximal inlet 221 of the distal end condenser 113, the condensation region 118 of the film 117 is at least partially received or secured between two adjacent sleeves via the outer distal inlet 223 or the inner distal inlet 224 of the distal end condenser 113. When the distal ends of the plurality of braided filaments 111 of the first portion 110 are received and secured through the inner proximal inlet 222 of the distal end condenser 113, the condensation region 118 of the film 117 is at least partially received or secured between two adjacent sleeves via any one of the outer proximal inlet 221, the outer distal inlet 223, and the inner distal inlet 224 of the distal end condenser 113. When the distal ends of the multiple braided filaments 111 of the first part 110 are received and fixed through the outer distal inlet 223 of the distal gathering member 113, the gathering region 118 of the film member 117 is at least partially received or fixed between the inner sleeve 2121 and the intermediate sleeve 2122 via the inner distal inlet 224 of the distal gathering member 113.

[0105] Example 9

[0106] The parts of the blocking device in Embodiment 9 that are the same as those in Embodiment 8 will not be described again here. The main difference between the two is that the distal condenser 113 of the first part 110 described in Embodiment 8 can also be used for the distal condenser 123 of the second part 120.

[0107] Specifically, the film element 124 of the second portion 120 at least covers a portion of the outer surface of the distal disk surface 128 of the second portion 120, and the convergence region 125 of the film element 124 is at least partially fixed within the distal convergence element 123 of the second portion 120. In other embodiments, the film element 124 on the second portion 120 may further cover the edge 127 of the second portion 120, that is, the side portion between the proximal disk surface 126 and the distal disk surface 128 of the second portion 120. Further, in other embodiments, the film element 124 on the second portion 120 may also cover the proximal disk surface 126 of the second portion 120, that is, the film element 124 covers the distal disk surface 128, the edge 127, and the proximal disk surface 126 of the second portion 120. Based on this, the various specific structures of the distal gathering member 113 provided on the first part 110 in Embodiment 8, as well as the various specific methods of accommodating and fixing the distal ends of multiple braided filaments 111 and the gathering area 118 of the film member 117, are also applicable to the distal gathering member 123 on the second part 120, and will not be described again here.

[0108] It should be noted that, in other embodiments, the relevant technical features of the extension 119 disposed on the edge 116 of the first part 110 or the edge 127 of the second part 120 as described in Embodiment 5 are also applicable to Embodiments 6 to 9, and will not be repeated here.

[0109] Example 10

[0110] The sealing device 300 of Example 10, such as Figure 19 As shown, the device includes a first portion 310 and a second portion 320 connected to the first portion 310. The first portion 310 includes a plurality of braided filaments 111 and a condenser (i.e., a proximal condenser 112) located at the proximal end of the plurality of braided filaments 111, which are received and secured within the proximal condenser 112, thereby fixing the proximal ends of the plurality of braided filaments 111 to the proximal condenser 112. The first portion 310 may also include a condenser (i.e., a distal condenser 113) located at the distal end of the plurality of braided filaments 111, which are received and secured within the distal condenser 113, thereby fixing the distal ends of the plurality of braided filaments 111 to the distal condenser 113.

[0111] The multiple braided filaments 111 of the first part 310 can be woven into a mesh tube shape, and after heat setting, it takes the form of a disc or column. In its unfolded state, the first part 310 includes a proximal disc surface 114 and a distal disc surface 115. The proximal disc surface 114 of the first part 310 is formed by the engagement of at least a portion of the multiple braided filaments 111 of the first part 310 located proximally. The distal disc surface 115 of the first part 310 is formed by the engagement of at least a portion of the multiple braided filaments 111 of the first part 310 located distally. The portion where the proximal disc surface 114 and the distal disc surface 115 of the first part 310 connect forms the edge 116 of the first part 310.

[0112] The proximal gathering member 112 of the first part 310 can be a hollow sleeve, or a double sleeve consisting of an inner sleeve 1121 and an outer sleeve 1122 as described in any of the above embodiments, or a three-layer sleeve consisting of an inner sleeve 2121, a middle sleeve 2122, and an outer sleeve 2123. Its structure and the method of gathering the braided filaments 111 are the same or similar technical features, and will not be described again here. The structure of the distal gathering member 113 of the first part 310 is not limited, and can be any of the aforementioned hollow sleeve, double sleeve, or three-layer sleeve.

[0113] In this embodiment, the distal constrictor 113 of the first part 310 is directly connected to the proximal end of the second part 320, without the need for a connector between the first part 310 and the second part 320. The second part 320 includes a plurality of support rods 321, and the proximal ends of the support rods 321 are all fixed to the distal constrictor 113 of the first part 310. The support rods 321 are provided with anchor spikes 322 for enhancing the anchoring stability of the second part 320 after penetrating the tissue. In other embodiments, the distal constrictor 113 of the first part 310 may be disposed within and fixedly connected to the proximal constrictor of the second part 320, thereby connecting the first part 310 and the second part 320. The specific structure of the second part 320 is not limited, and in other embodiments it may also be the second part 120 described in Embodiment 1.

[0114] The convergence region 318 of the first portion 310 refers to the portion along the radial direction of the first portion 310, close to the central axis of the first portion 310. The covered area can be a region centered on the central axis of the first portion 310 with a radius ranging from 1 / 4 to 1 / 2 of the radius of the first portion 310. The convergence region 318 of the first portion 310 includes a portion of multiple braided filaments 111 that is converged by shape. In one implementation of this embodiment, the convergence portion includes a first convergence portion 311 and a second convergence portion 312, and a portion of the outer surface of the convergence portion forms part of the proximal disc surface 114. The first convergence portion 311 and the second convergence portion 312 approach each other when no external force is applied, so as to surround the proximal convergence member 112 of the first portion 310 within the space enclosed by the first convergence portion 311 and the second convergence portion 312 within the first portion 310. This avoids the risk of thrombosis forming at the proximal fascicle 112, which is closer to the proximal end than the proximal disc 114 in the first part 310, i.e., the proximal fascicle 112 protruding towards the proximal end of the proximal disc 114.

[0115] In one embodiment, after the occlusion device 300 is connected to the distal end of the delivery cable and housed together within a sheath, and then implanted into the cavity of the left atrial appendage or other internal tissues, the sheath is retracted proximally to allow the occlusion device 300 to expand and unfold after the radial restraint provided by the sheath is released, thereby achieving release. After release, in one embodiment, the edge of the distal disc 115 of the first part 310 abuts against the tissue at the opening of the left atrial appendage, thereby sealing the opening of the left atrial appendage. Figure 19 and Figure 20A As shown, after the sheath (not shown) is retracted, before the delivery cable 400 is disconnected from the sealing device 300, the distal end of the delivery cable 400 remains connected to the proximal gathering member 112 of the first part 310. The connection method can be a threaded connection, which is not limited here. At this time, the first gathering portion 311 and the second gathering portion 312 move away from each other under the external force provided by the distal portion of the delivery cable 400. Specifically, the opposing portions of the first gathering portion 311 and the second gathering portion 312, centered on the distal end of the delivery cable 400, abut against the distal portion of the delivery cable 400. A cross-sectional view of this portion from the proximal end to the distal end is provided by [reference needed]. Figure 20B .

[0116] Combination Figure 19 and Figure 21A As shown, when the distal end of the transmission cable 400 is disconnected from the proximal end gathering member 112 of the first part 310, the first gathering part 311 and the second gathering part 312 move closer to each other due to the loss of the external force exerted by the distal end of the transmission cable 400. Please refer to the cross-sectional diagram viewed from the proximal end to the distal end. Figure 21BThe proximal disc surface 114, after the first converging portion 311 and the second converging portion 312 approach each other, is approximately closed, thereby enclosing the proximal converging member 112 of the first portion 310 within the space enclosed by the first converging portion 311 and the second converging portion 312 within the first portion 310. Specifically, it encloses the space between the proximal disc surface 114 and the distal disc surface 115 of the first portion 310. At this time, the proximal disc surface 114 is flat and closed, so after the occlusion device 300 is fully released, under the continuous flushing of blood flow, it is not easy for a thrombus to form at the proximal disc surface 114 of the first portion 310, thus improving the safety of the operation.

[0117] It should be noted that, please refer to Figure 21B There may be a small gap when the first gathering part 311 and the second gathering part 312 come close to each other. Figure 21B The gap exists at the very center of the small hole, and its maximum outer diameter is less than or equal to 5 mm, preferably less than or equal to 3 mm. In actual design, the size of this gap is generally smaller than the mesh size of the braided net formed by multiple braided wires 111 or smaller than the inner diameter of the inner sleeve. Therefore, even if there is still a gap after the first gathering part 311 and the second gathering part 312 approach each other, it will often not induce the formation of thrombus. It can also be regarded as the proximal disc surface 114 formed by the cooperation of a part of the outer surface of the first gathering part 311 and the second gathering part 312 is still closed.

[0118] In another embodiment, if a gap still exists after the first gathering portion 311 and the second gathering portion 312 approach each other, a sealing element can be provided at the gap to ensure that the proximal disc surface 114 formed by the cooperation of the first gathering portion 311 and the second gathering portion 312 is sealed. The sealing element can be a gel-like substance such as an embolic agent, characterized by its relatively stable shape after solidification and resistance to liquid penetration. After the transport cable 400 is disconnected from the first portion 310, the embolic agent can be injected into the space enclosed by the first gathering portion 311 and the second gathering portion 312, thereby filling the space and ensuring that the proximal disc surface 114 is sealed. The sealing element can also be a compressible and self-expanding cap connected to the first portion 310, thus covering the gap after the cap unfolds, similarly ensuring that the proximal disc surface 114 is sealed. The sealing element can also be a component of other structures; the structure is not limited, as long as it can seal the proximal disc surface 114. These will not be listed here individually. In addition, blood flow is prone to thrombosis after passing through the gap and entering the space enclosed by the converging part. The thrombus formed is not easy to overflow from the gap and will remain stably in the space, thus filling the space and making the plate surface closed.

[0119] In other embodiments, the specific shape, number, and location of the gathering portions on the first portion 310 are not limited, as long as the gathering portions can surround the proximal constrictor 112 or the distal constrictor 113 inside the first portion 310 in a natural state or after the removal of external force, thereby avoiding the risk of thrombosis caused by the proximal constrictor 112 or the distal constrictor 113 protruding outside the first portion 310. Furthermore, since the gathering portions surrounding the proximal constrictor 112 or the distal constrictor 113 form a flat and closed disc surface, the risk of thrombosis easily inducing on the outer side of the first portion 310 can be completely avoided. It is understood that the relevant features of the gathering portions provided on the first portion 310 can also be applied to the second portion 320.

[0120] The sealing device 300 also includes one or more thin film elements 117 disposed on the first part 310. For example... Figure 19 As shown, the film element 117 covers the proximal disc surface 114 and edge 116 of the first portion 310, and thus the film element 117 also covers the outer surface of the first gathering portion 311 and the outer surface of the second gathering portion 312. The convergence area of ​​the film element 117 at least partially accommodates or fixes within the proximal gathering member 112 of the first portion 310. It should be noted that the technical features related to the film element 117 in this embodiment are the same as or similar to the technical features related to the film element 117 in Embodiment 1, and will not be repeated here. The film element 117 provided on the first portion 310 can further improve its sealing performance and achieve multi-layer sealing. In other embodiments, the film element 117 may not be provided on the first portion 310, as long as the first gathering portion 311 and the second gathering portion 312 cooperate to form a flat proximal disc surface 114, thrombus formation at the proximal disc surface 114 can be avoided. In other embodiments, the film 117 covers a portion of the outer surface of the first gathering portion 311, or a portion of the outer surface of the second gathering portion 312, or a portion of the outer surface of each of the first gathering portion 311 and the second gathering portion 312.

[0121] The specific shapes of the first gathering portion 311 and the second gathering portion 312 are not limited, as long as they can close together to form a closed and flat proximal disk surface 114. In other embodiments, such as Figure 22As shown, the first gathering portion 311 includes a protrusion 313 and a recess 314, and the second gathering portion 312 includes a recess 315 and a protrusion 316. When the first gathering portion 311 and the second gathering portion 312 are brought close together, the protrusion 313 of the first gathering portion 311 abuts against the recess 315 of the second gathering portion 312, and the recess 314 of the first gathering portion 311 abuts against the protrusion 316 of the second gathering portion 312, so that the first gathering portion 311 and the second gathering portion 312 can fit together more fully and more easily form a relatively flat proximal disc surface 114, avoiding the formation of thrombi at the proximal disc surface 114. In another embodiment, the first gathering portion 311 includes a plurality of protrusions 313 and a plurality of recesses 314, and the second gathering portion 312 includes a plurality of recesses 315 and a plurality of protrusions 316. When the first gathering portion 311 and the second gathering portion 312 approach each other, the plurality of protrusions 313 of the first gathering portion 311 abut against one recess 315 of the second gathering portion 312, and the plurality of recesses 314 of the first gathering portion 311 abut against one protrusion 316 of the second gathering portion 312. Thus, when the first gathering portion 311 abuts against the second gathering portion 312, the proximal disc surface 114 of the first portion 310 is closed, and the proximal constrictor 112 of the first portion 310 is enclosed inside the first portion 310 and does not come into contact with blood, thereby preventing the formation of thrombi. In these embodiments, the first gathering portion 311 and the second gathering portion 312 partially overlap in the axial direction and also partially overlap in the radial direction. To ensure that the formed proximal disk surface 114 is closed, the first gathering portion 311 and the second gathering portion 312 approach each other and fit together at least in the radial direction. In other embodiments, a plurality of protrusions 313 of the first gathering portion 311 may abut against one of the recesses 315 of the second gathering portion 312, which also allows the first gathering portion 311 and the second gathering portion 312 to abut against each other.

[0122] Furthermore, in other embodiments, the first part 310 is also provided with a reset member. After the external force is released, the reset member brings the first gathering part 311 and the second gathering part 312 together. In one embodiment, such as Figure 23As shown, the reset member 317 includes magnets 3171 and 3172 with opposite magnetic properties. Magnet 3171 is disposed on the first gathering portion 311, and magnet 3172 is disposed on the second gathering portion 312. The number and specific placement of magnets with the same magnetic properties are not limited. For example, magnets can also be disposed on the proximal gathering member 112 of the first portion 310 to attract the magnets disposed on the first gathering portion 311 and / or the second gathering portion 312. After the force exerted on the first gathering portion 311 and the second gathering portion 312 by the conveying cable 400 is released, they then converge towards each other under the mutual attraction of the two magnets, promoting the first gathering portion 311 and the second gathering portion 312 to approach each other and ultimately form a closed proximal disc surface 114.

[0123] In another embodiment, such as Figure 24 As shown, the reset member 318 includes a first reset rod 3181 disposed near the first gathering portion 311 and a second reset rod 3182 disposed near the second gathering portion 312. The first gathering portion 311 and the second gathering portion 312 are brought together by the action of the first reset rod 3181 and the second reset rod 3182. Specifically, one end of the first reset rod 3181 is fixed to the distal end of the proximal gathering member 112 of the first portion 310, and the other end extends from the distal end of the proximal gathering member 112 toward the proximal disk surface 114, and extends radially outward a certain distance near the proximal disk surface 114, without extending beyond the edge 116 of the first portion 310; the second reset rod 3182 is symmetrically disposed with the first reset rod 3181 centered on the proximal gathering member 112. In another embodiment, the first reset rod 3181 and the second reset rod 3182 are symmetrically arranged, with one end of the first reset rod 3181 fixed to the distal end of the proximal convergence member 112, and the other end extending from the distal end of the proximal convergence member 112 and bending towards the first gathering portion 311; one end of the second reset rod 3182 is fixed to the distal end of the proximal convergence member 112, and the other end extending from the distal end of the proximal convergence member 112 and bending towards the second gathering portion 312. In these embodiments, when the first portion 310 is housed within the sheath, both the first reset rod 3181 and the second reset rod 3182 conform to the deformation of the first portion 310 and are approximately straight, and can return to the above shape after the first portion 310 is released from the sheath constraint, thereby promoting the first gathering portion 311 and the second gathering portion 312 to approach each other and ultimately form a closed proximal disc surface 114.

[0124] In another embodiment, such as Figure 25As shown, the reset member 319 includes an elastic coil connecting the first gathering portion 311 and the second gathering portion 312. The elastic coil has good elasticity, allowing it to expand radially outward when the transport cable 400 is connected to the near-end retractor 112, so as not to obstruct the connection or hinder the separation of the first gathering portion 311 and the second gathering portion 312; it also allows the first gathering portion 311 and the second gathering portion 312 to converge together under the contraction of the elastic coil after the transport cable 400 is disconnected from the near-end retractor 112. One or more such elastic coils can be provided as needed.

[0125] In some other embodiments, all the technical features described in any of the embodiments 1 to 9 above may be included respectively. That is, the technical features of the first part 310 described in embodiment 10 can be regarded as a continuation on the basis of any of the embodiments 1 to 9 above, and the same parts will not be described again here.

[0126] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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.

[0127] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A sealing device, comprising a first part, the first part comprising a plurality of braided filaments and a gathering member, one end of the plurality of braided filaments being fixed to the gathering member, the first part having at least one disc surface, characterized in that, The gathering member includes a hollow inner sleeve and an outer sleeve, and at least the portion of the disk surface at the proximal end of the first part that is close to the gathering member is perpendicular to the central axis of the gathering member, thereby forming a relatively flat disk surface near the gathering member. A portion of the multiple braided filaments converges to form a gathering portion, a portion of the outer surface of the gathering portion forms part of the proximal disc surface, and the gathering portion surrounds the gathering member within the space enclosed by the gathering portion without external force.

2. The sealing device according to claim 1, characterized in that, One end of the gathering member is provided with an end cap that is connected to the inner sleeve, and one end of the multiple braided wires extends from the gap between the end cap and the outer sleeve into the gap between the inner sleeve and the outer sleeve.

3. The sealing device according to claim 2, characterized in that, The end cap and the inner sleeve are integrally formed.

4. The sealing device according to any one of claims 2-3, characterized in that, The end cap is connected to the proximal end of the inner sleeve.

5. The sealing device according to any one of claims 2-3, characterized in that, The sealing device further includes a thin film element that covers at least a portion of the outer surface of the disk. The film element has an opening in its convergence area, and the portion of the film element that encloses the opening is received and fixed within the convergence element.

6. The sealing device according to claim 5, characterized in that, The convergence region of the thin film is at least partially housed or fixed between the inner sleeve and the outer sleeve.

7. The sealing device according to claim 6, characterized in that, The end cap is provided with a fine groove, and the portion of the thin film that forms the opening is fixedly clamped in the fine groove.

8. The sealing device according to any one of claims 2-3 and 6-7, characterized in that, The inner wall of the inner sleeve is provided with threads or snap-fit ​​components.

9. The sealing device according to any one of claims 2-3 and 6-7, characterized in that, The length of the inner sleeve is greater than the length of the outer sleeve.

10. The sealing device according to any one of claims 2-3 and 6-7, characterized in that, The proximal end of the inner sleeve and the proximal end of the outer sleeve together form the proximal inlet of the gathering member, and the distal end of the inner sleeve and the distal end of the outer sleeve together form the distal inlet of the gathering member. One end of the plurality of braided filaments is fixed between the inner sleeve and the outer sleeve after passing through the proximal inlet or the distal inlet of the gathering member.

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