CN113116405B

CN113116405B - Plugging device

Info

Publication number: CN113116405B
Application number: CN201911404185.1A
Authority: CN
Inventors: 李安宁; 刘建勇; 王洪岩; 唐玉华
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2019-12-30
Filing date: 2019-12-30
Publication date: 2022-07-05
Anticipated expiration: 2039-12-30
Also published as: CN113116405A

Abstract

The invention relates to a plugging device, which comprises a sealing disc and a flow resisting film arranged in the sealing disc, wherein the sealing disc comprises a near-end disc surface and a far-end disc surface, the flow resisting film is arranged between the near-end disc surface and the far-end disc surface, the sealing disc also comprises a traction piece arranged in the sealing disc, and the traction piece is respectively connected with the middle area of the flow resisting film, the middle area of the near-end disc surface or the middle area of the far-end disc surface; when one end of the sealing disc is far away from the other end of the sealing disc, the traction piece drives the middle area of the flow resistance film to move along with the end part of the sealing disc so as to axially fold the flow resistance film. The plugging device solves the technical problem that a flow resisting membrane is easy to stack in the sealing disc when the sealing disc enters a sheath, so that the sheath entering is difficult, and the outer diameter of the sealing disc when the sheath enters the sheath can be as small as possible, so that a sheath tube with a smaller size can be adopted.

Description

Plugging device

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to a plugging device.

Background

Occlusion devices are increasingly used as interventional treatment devices in surgeries requiring treatment with interventional means. Plugging devices such as left atrial appendage occluders, atrial septal defect occluders, aneurysm occluders and the like are increasingly trusted by doctors and patients due to the characteristics that the plugging device has excellent plugging performance and almost no complications which can endanger life after being implanted into the bodies of the patients.

Taking a left atrial appendage occluder as an example, a sealing disk with a built-in flow-blocking membrane is generally used to occlude the mouth of the left atrial appendage. After the sealing disc is unfolded, the choke membrane covers the whole disc surface inner side of the sealing disc. Since the left atrial appendage occluder needs to be bundled into a linear shape by the sheath before being released in vivo, the flow-blocking membrane in the sealing disk needs to be folded into a small size as much as possible to reduce the size of the sheath to be used cooperatively. However, when the seal disk is subjected to sheath insertion, the flow-resisting membrane is easily stacked in the seal disk, resulting in a large outer diameter of the seal disk after compression, which is disadvantageous in sheath insertion.

Disclosure of Invention

Based on this, it is necessary to provide a new plugging device for the technical problem that the flow resisting membrane is easy to stack in the sealing disc when the sealing disc enters the sheath, thereby influencing the sheath.

A plugging device comprises a sealing disc and a flow resisting film arranged in the sealing disc, wherein the sealing disc comprises a near-end disc surface and a far-end disc surface, the flow resisting film is arranged between the near-end disc surface and the far-end disc surface, the sealing disc further comprises a traction piece arranged in the sealing disc, and the traction piece is respectively connected with the middle area of the flow resisting film, the near-end disc surface or the middle area of the far-end disc surface; when one end of the sealing disc is far away from the other end of the sealing disc, the traction piece drives the middle area of the flow resistance film to move along with the end part of the sealing disc so as to axially fold the flow resistance film.

In one embodiment, the sealing disc is a mesh tube made of a plurality of wires, and a portion of the pulling member is wrapped around at least one wire in the middle region of the proximal disc face or the distal disc face.

In one embodiment, a portion of the traction element is wrapped around at least one wire of the proximal disc face or the middle region of the distal disc face for at least two turns.

In one embodiment, the traction piece comprises a first section, a second section and a third section which are connected in sequence; a part of the first section is wound around the middle area of the near-end disc surface or the far-end disc surface, a part of the third section penetrates through one side of the current-blocking film and penetrates back from the other side of the current-blocking film after a preset distance, and the second section is positioned between the current-blocking film and the near-end disc surface or the far-end disc surface; the end part of the first section of the traction piece is fixedly connected with the end part of the third section.

In one embodiment, the traction elements are attached to a plurality of attachment points in the medial region of the proximal or distal disc surfaces.

In one embodiment, there are two of the connection points, and the two connection points are symmetrical with respect to the central axis of the sealing disk.

In one embodiment, the traction piece comprises a first section, a second section and a third section which are connected in sequence; a part of the first section is wound around a first connection point of the middle area of the near-end disc surface or the far-end disc surface, a part of the second section is wound around a second connection point of the middle area of the near-end disc surface or the far-end disc surface, and a part of the third section penetrates through one side of the flow resistance film and penetrates back from the other side of the flow resistance film after being spaced by a preset distance; the end part of the first section of the traction piece is fixedly connected with the end part of the third section.

In one embodiment, there are 5 of the connection points and the pulling elements are distributed in the sealing disc in the shape of a five-pointed star.

In one embodiment, the 5 connection points are a first connection point, a second connection point, a third connection point, a fourth connection point and a fifth connection point which are uniformly distributed around the central axis of the sealing disc in a circumferential manner; one end of the traction piece is sequentially and respectively wound around the first connection point, the third connection point, the fifth connection point, the second connection point and the fourth connection point and then fixedly connected with the other end of the traction piece.

In one embodiment, the sealing disc further comprises a converging piece arranged at the end part of the sealing disc, and a convex part facing the inside of the sealing disc is arranged on the converging piece; when the sealing disk is expanded, the tip of the boss abuts the intermediate region of the flow blocking membrane.

Above-mentioned plugging device, through setting up the piece that draws in sealed dish inside, the middle zone that will hinder the flow membrane is connected with the middle zone of the near-end quotation or the distal end quotation of sealed dish for when the one end of sealed dish was kept away from its other end, the piece that draws can drive the middle zone that hinders the flow membrane and remove along with the tip of sealed dish, thereby carry out axial folding with the choked flow membrane, the external diameter that makes the choked flow membrane after folding is as little as possible, can not pile up in the inside of sealed dish and influence into the sheath.

Drawings

Fig. 1 is a schematic structural view of an upper net pipe portion on a sealing disc of a plugging device of embodiment 1;

FIG. 2 is a schematic view showing the overall structure of the occluding device of example 1;

FIG. 3 is a schematic view of the seal disk of FIG. 2 directly against its proximal disk surface;

FIG. 4 is an enlarged view of the portion A of FIG. 3;

FIG. 5 is a schematic view of the seal disk with a boss on the proximal end constriction member;

FIG. 6 is another schematic view of the seal disk with a boss on the proximal end constriction member;

fig. 7 is a schematic structural view of a seal-plate-like net pipe portion of the plugging device according to embodiment 2;

FIG. 8 is a schematic view of the seal disk of FIG. 7 directly against its proximal disk surface;

FIG. 9 is an enlarged view of the portion B of FIG. 8;

FIG. 10 is a schematic view of the sealing disc of the occluding device of example 3 facing the proximal disc surface thereof;

FIG. 11 is an enlarged view of the portion C of FIG. 10;

fig. 12 is a schematic structural view of fig. 11 with the portion of the knitted yarn showing the C portion omitted.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is 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 of the invention and are not intended to limit the invention.

In the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to an operator is generally referred to as the "proximal end", the end farther from the operator is referred to as the "distal end", and the "proximal end" and the "distal end" of any component of the medical device are defined according to this principle. "axial" generally refers to the length of the medical device as it is being delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines both "axial" and "radial" directions of any component of the medical device in accordance with this principle.

The technical solution of the present invention will be further described in detail with reference to the following specific embodiments by taking the occlusion in the left atrial appendage as an example.

Example 1

This embodiment provides an occlusion device that may be used to occlude an opening in a tissue of a human or animal body, such as a foramen ovale, left atrial appendage, or the like. Referring to fig. 1 and 2, the plugging device 100 includes a sealing disc 110 and a flow blocking membrane 111 disposed inside the sealing disc 110, and an edge portion of the flow blocking membrane 111 is fixed on a woven mesh of the sealing disc 110 by sewing or adhesive bonding or the like through a suture line. The flow blocking membrane 111 covers the whole inner side disc surface of the sealing disc 110 after the sealing disc 110 is unfolded, and is used for preventing blood from passing through the sealing disc 110 from one side of the sealing disc 110 to the other side, so that the internal opening is blocked. The shape of the flow-blocking membrane 111 may conform to the shape of the disk surface after the seal disk 110 is released, for example, a circular shape. At least one flow-resisting film 111 is arranged in the sealing disc 110, and the arrangement of a plurality of flow-resisting films 111 can improve the sealing performance of the sealing disc 110. The flow blocking film 111 may be a PET film or other polymer film.

The sealing disc 110 is a mesh tube made of a plurality of wires, which may be braided wires or cut rods. Taking the mesh tube made of braided filaments as an example, the tubular braided mesh of the sealing disk 110 is made of at least one braided filament by braiding. The two ends of the mesh are respectively closed by the proximal closing member 112 and the distal closing member 113 and the woven wire is fixed. Both the proximal and

distal constrictions

112, 113 may be hollow cannulae. The two sleeves thus form the proximal and distal ends of the sealing disk 110. The sealing disk 110 includes a proximal disk face 114 and a distal disk face 115 between the two sleeves, and the flow blocking membrane 111 is disposed between the proximal disk face 114 and the distal disk face 115.

In this embodiment, the woven mesh of the seal disk 110 is heat-set in a flat disk shape, but in other embodiments, the woven mesh of the seal disk 110 may have a columnar shape, a plug shape, or the like. The shape of the seal disk 110 is not limited as long as plugging can be achieved.

Referring to fig. 2, the plugging device 100 further includes a fixed disk 120, and the fixed disk 120 is directly connected to the sealing disk 110 or indirectly connected thereto through at least one connector. The shape of the stationary disk 120 is not limited as long as the occluding device 100 can be secured in a specific location in the body after release. For example, the fixation disc 120 may be cylindrical or umbrella-shaped and capable of abutting against the inner wall of the left atrial appendage after release, thereby securing the occluding device 100 within the left atrial appendage. Further, at least one anchor 121 may be provided on the support rods or the woven wire of the fixed platter 120. After the stationary disk 120 is released, the anchor 121 can penetrate into the inner wall of the left atrial appendage to a certain depth to further improve the fixing of the stationary disk 120.

Taking the left atrial appendage occlusion as an example, after the occlusion device 100 is released in the left atrial appendage, the fixing disc 120 is located in the cavity of the left atrial appendage and abuts against the inner wall of the left atrial appendage, so as to fix the entire occlusion device 100 at the left atrial appendage; the sealing disc 110 is tightly attached to or clamped in the mouth of the left atrial appendage after being released, and is used for sealing the opening of the mouth of the left atrial appendage. The fixed disk 120 is located at the distal end of the occluding device 100 and the sealing disk 110 is located at the proximal end of the occluding device 100 so that the fixed disk 120 is released before the sealing disk 110.

When the occluding device 100 is delivered from the outside of the body to the inside of the body, it is constrained to be approximately linear by a delivery device such as a sheath. Taking the sheath as an example, when the sheath is withdrawn towards the proximal end during in vivo release, the fixation disc 120 at the distal end first protrudes from the lumen of the sheath and self-expands until it returns to the heat-set shape. The released fixation disc 120 may be fixed to the inner wall of the body tissue having the cavity, such as the left atrial appendage, to fix the occluding device 100 to the body tissue. Thereafter, the sheath is further withdrawn towards the proximal end, and the sealing disc 110 protruding from the cavity of the sheath expands to the heat-set shape by self-expansion, thereby covering or blocking the opening of the part to be blocked, and smoothly achieving the blocking.

Referring to fig. 1, 3 and 4 together, the sealing disk 110 further includes a drawing member 116 disposed inside the sealing disk 110, and the drawing member 116 is connected to the middle region of the obstructing membrane 111 and the middle region of the proximal disk surface 114, respectively. The middle region of the choke membrane 111 is a circular region with the center point of the choke membrane 111 after deployment as the origin and a preset proportion of the maximum radius of the choke membrane 111 as the radius, wherein the preset proportion is preferably less than or equal to one fifth. The intermediate region of the proximal disk surface 114 or the distal disk surface 115 is a circular region having a radius of a preset ratio of the maximum radius of the sealing disk 110, with the center point of the expanded sealing disk 110 as the origin, wherein the preset ratio is preferably less than or equal to one fifth. When one end of the sealing disc 110 is far away from the other end thereof, the pulling member 116 drives the middle area of the flow blocking membrane 111 to move along with the end of the sealing disc 110 to fold the flow blocking membrane 111. For example, when the occluding device 100 is not fully released, the sealing disc 110 may self-expand and expand, but the distal end of the delivery cable and the proximal end of the sealing disc 110 are still connected together. When the sheath is kept still and the delivery cable is withdrawn towards the proximal end, the delivery cable will drive the sealing disc 110 to extend and compress gradually from the proximal end to the distal end of the sealing disc 110 to be accommodated in the sheath. During the process that the sealing disc 110 is gradually accommodated in the sheath, the flow blocking membrane 111 inside the sealing disc 110 is moved synchronously with the movement of the knitting filaments at the junctions on the middle area of the proximal disc surface 114 or the distal disc surface 115 of the sealing disc 110 due to the action of the traction piece 116. And because the middle area of the flow-blocking film 111 is closer to the end of the sealing disc 110 than the edge of the flow-blocking film 111, the middle area of the flow-blocking film 111 is accommodated in the sheath tube in advance than the edge of the flow-blocking film 111, so that the axial folding of the flow-blocking film 111 is realized, and the influence on sheath entry caused by stacking of the flow-blocking film 111 when the sealing disc 110 is accommodated in the sheath tube is avoided.

In another embodiment, the pulling elements 116 are connected to the middle region of the spoiler film 111 and the middle region of the distal disc surface 115, respectively. Similar to the principle of the pulling member 116 being pulled by the middle region of the proximal disc surface 114 to fold axially into the sheath, the middle region of the distal disc surface 115 is also capable of pulling the flow barrier membrane 111 to fold axially into the sheath. In contrast, when the sheath is folded, the edge of the spoiler 111 is accommodated in the sheath before the middle region of the spoiler 111.

In another embodiment, the pulling elements 116 are connected to the middle regions of the blocker film 111, the proximal disc surface 114, and the distal disc surface 115, respectively. It will be appreciated that with the appropriate length of the first portion of the tow member 116 connecting the intermediate region of the resistive diaphragm 111 to the intermediate region of the proximal disk face 114, and the second portion of the tow member 116 connecting the intermediate region of the resistive diaphragm 111 to the intermediate region of the distal disk face 115, axial furling of the resistive diaphragm 111 into the sheath can be achieved under the combined pulling action of the intermediate regions of the proximal and distal disk faces 114, 115, thereby avoiding the problem of stacking and difficult sheathing. Here, the first portion and the second portion of the pulling member 116 may correspond to different portions of the same pulling member 116, or may be two independent pulling members 116.

In this embodiment, the number of the pulling members 116 is one. In other embodiments, the number of traction members 116 may be two or more. The plurality of traction members 116 can enhance the traction firmness and the traction strength of the proximal constriction 112 or the distal constriction 113 on the obstructing membrane 111, so as to prevent the traction members 116 between the obstructing membrane 111 and the proximal constriction 112 or the distal constriction 113 from being too loose to easily extend out of the sealing disc 110 and further climb to thrombus.

In this embodiment, the pulling member 116 is a polymer wire. In other embodiments, the pulling member 116 may be a wire with elasticity, so long as the wire is not protruded significantly when being wound around the proximal disc surface 114.

Specifically, the traction elements 116 are attached to the middle region of the proximal disk face 114 or distal disk face 115 in such a manner that the traction elements 116 are wrapped around one or more wires of the middle region of the proximal disk face 114 or distal disk face 115 and wrapped at least one turn, as shown in FIG. 4, to attach the traction elements 116 to the sealing disk 110. Fig. 3 shows the case of winding two turns. The traction member 116 is wound on the proximal disc surface 114 or the distal disc surface 115 by at least two circles of wires, so that the friction between the traction member 116 and the wires can be increased, the traction member 116 is in a tensioned state on the wires, and two ends of the winding position are close to the intersection of the wires, so that after the sealing disc 110 is released, the part of the traction member 116 at the winding position is not easy to bulge towards the outside of the sealing disc 110 to induce the formation of thrombus.

Referring again to fig. 1 and 3, the pulling member 116 includes a first section, a second section, and a third section connected in series. When the pulling member 116 is a suture, the obstructing membrane 111 and the proximal disk surface 114 may be connected by a suture needle in cooperation with the suture. During the sewing, a needle (corresponding to position 1 in fig. 1) can be inserted into the sealing disk 110 at a distance of one third from the center of the proximal disk surface 114, and the needle penetrates and passes through the proximal surface of the obstructing membrane 111 with the suture, i.e., a part of the third section of the pulling element 116 passes through the obstructing membrane 111; after moving toward the central axis of the sealing disk 110 and being spaced apart by a predetermined distance, the suture needle pierces and penetrates from the side of the distal end surface of the obstructing membrane 111 to the side of the proximal end surface (corresponding to position 2 in fig. 1); the suture needle continues to penetrate out of the sealing disc 110 at a position close to the region of the sealing disc 110 where the bending degree of the proximal disc surface 114 is large when the sealing disc is unfolded, so that the second section of the traction piece 116 is positioned between the flow blocking film 111 and the proximal disc surface 114 and is in a suspended state; the suture needle is then wrapped at least two times around the one or more braided filaments in the middle region of the proximal disc surface 114 (corresponding to position 3 in fig. 1), thereby wrapping a portion of the first segment of the traction element 116 around the middle region of the proximal disc surface 114; finally, the suture is tied at both ends determined at the appropriate length (corresponding to position 4 in fig. 1), thereby fixedly connecting the end of the first segment of the pulling member 116 with the end of the third segment.

The value range of the preset distance is 2mm to 4mm, so that the membrane between the two through holes is prevented from being easily broken when the plugging device 100 is operated when the distance is too small, the traction piece 116 is disconnected from the flow blocking membrane 111, and the local accumulation of the flow blocking membrane caused by too large distance is avoided, so that the resistance of entering the sheath is increased. When the traction member 116 is a suture, the connection between the obstructing membrane 111 and the distal disk surface 115 is performed in a manner of a suture needle matching the suture, and thus, the description thereof is omitted. The connection process when the pulling member 116 is a wire is also similar to the connection process by a suture, and will not be described again.

In other embodiments, referring to FIG. 5, the proximal constriction 112 of the sealing disk 110 is a sleeve comprising an annular sidewall and a bottom wall facing the flow-blocking membrane 111. The bottom wall of the sleeve is provided with a projection 117 facing the inside of the sealing disc 110. When the sealing disk 110 is expanded, the tip of the boss 117 abuts the middle area of the flow-blocking membrane 111. The boss 117 in fig. 5 is a portion of the bottom of the sleeve that protrudes toward the sealing disk 110. In other embodiments, referring to fig. 6, the protrusion 117 may be a separate component, such as a spring-like component, and one end of the protrusion 117 is connected to the bottom of the proximal constricting element 112 and the other end is connected to or suspended in the middle region of the flow-blocking membrane 111. The end of the projection 117 remote from the proximal constriction 112 may also be connected to the traction element 116 at the middle region of the blocker membrane 111. The length of the protrusion 117 should be moderate, and the suspended end should be a smooth end to avoid piercing the flow-blocking membrane 111. When the sealing disc 110 is bent under force, the probability that the pulling member 116 is exposed from the inside of the sealing disc 110 is increased, and the protrusion 117 can always give a pushing force to the middle area of the flow blocking film 111 or the pulling member 116 toward the distal end, so that the pulling member 116 can be still in a tightened state when the sealing disc 110 is bent without protruding from the inside of the sealing disc 110. In other embodiments, the protrusion 117 may also be disposed on the distal end contracting member 113, and the structure and function thereof are the same as the protrusion 117, which will not be described herein again.

In another embodiment, as shown in FIG. 5, the proximal stop 112 may also be an inner sleeve and an outer sleeve in a nested arrangement, the inner wall of the inner sleeve being threaded for threaded connection with the distal end of the delivery device. The proximal end of the braided mesh of the sealing disc 110 is captured between the inner and outer sleeves. The bottom wall of the proximal end retainer 112 is provided with a projection 117 facing the interior of the sealing disk 110. The structure and function of the protrusion 117 are the same as those of the protrusion 117, and are not described herein again.

Example 2

The same parts of the occluding device of example 2 as those of the occluding device 100 of example 1 are not described again. The difference between the two is mainly that in the embodiment 2, the traction element 116 is connected with a plurality of connecting points in the middle area of the proximal disc surface 114 or the distal disc surface 115, so that the traction element 116 at the connecting points is partially pulled mutually, and the traction element 116 is not easily protruded from the sealing disc 110 to induce the formation of thrombus. Further, the plurality of connection points are uniformly distributed centering on the central axis of the seal disk 110. The traction pieces 116 at the uniformly distributed connecting points are mutually pulled and restricted to a certain extent, so that the phenomenon that the flow blocking film 111 is torn and damaged due to overlarge stress at the individual connecting points can be avoided.

Specifically, taking the proximal disc surface 114 as an example, referring to fig. 7 to 9, there are two connecting points of the pulling member 116 and the proximal disc surface 114, and the two connecting points are symmetrical with respect to the central axis of the sealing disc 110. The pulling member 116 includes a first section, a second section, and a third section connected in series. When the pulling member 116 is a suture, the obstructing membrane 111 and the proximal disk surface 114 may be connected by a suture needle in cooperation with the suture. During the sewing, a needle (corresponding to position 1 in fig. 7) can be inserted into the sealing disk 110 at a distance of one third from the center of the proximal disk surface 114, and the needle with the suture penetrates and passes through the side of the proximal surface of the obstructing membrane 111, i.e., a part of the third section of the pulling element 116 passes through the side of the obstructing membrane 111; after moving toward the central axis of the seal disk 110 and being spaced apart by a predetermined distance, the suture needle pierces from the side of the distal end surface of the flow obstructing membrane 111 and penetrates back to the side of the proximal end surface (corresponding to position 2 in fig. 7); the suture needle continues to pass out of the sealing disc 110 at a location near the region of the sealing disc 110 where the proximal disc surface 114 is more curved when deployed; thereafter, the suture needle is wrapped one turn around the one or more braided wires in the middle region of the proximal disc surface 114 (corresponding to position 3 in fig. 7), thereby wrapping a portion of the first segment of the traction element 116 around the first attachment point in the middle region of the proximal disc surface 114; the needle starts at position 3, moves inside the gland plate 110, aligned with the central axis of the gland plate 110, towards a position symmetrical to position 3 within the middle area of the proximal disc surface 114 (corresponding to position 4 in fig. 7), and winds one or more braids at position 4, thereby winding a portion of the second section of the pulling element 116 around the second connection point of the middle area of the proximal disc surface 114; finally, the suture is tied at both ends determined at the appropriate length (corresponding to position 5 in fig. 7), thereby fixedly connecting the end of the first segment of the pulling member 116 with the end of the third segment.

Wherein the predetermined distance may be a distance, for example, 3mm to 5mm, from a position symmetrical to the position 1 in fig. 7 with the central axis of the seal disk 110. When the traction member 116 is a suture, the connection between the obstructing membrane 111 and the distal disk surface 115 is performed in a manner of a suture needle matching the suture, and thus, the description thereof is omitted. The connection process when the pulling member 116 is a wire is also similar to the connection process by a suture, and will not be described again.

Further, in other embodiments, the proximal or distal stop of the gland plate 110 is a sleeve with a boss 117 facing the interior of the gland plate 110, as shown in FIGS. 5 and 6. The structure, function and other features of the protruding portion 117 are the same as those of embodiment 1, and are not described again.

In other embodiments, at least two connection points in the middle region between the traction member 116 and the proximal disc surface 114 or the distal disc surface 115 are realized by winding a portion of the traction member 116 around at least two turns of at least one wire at the corresponding connection points, which is not described herein again.

It will be appreciated that in other embodiments, the traction elements 116 are connected to a plurality of connection points in the middle region of the proximal disk face 114 or the distal disk face 115, and that the plurality of connection points may not be symmetrical about the central axis of the sealing disk 110. For example, if the two connection points in the middle region of the proximal disc surface 114 are the connection point a and the connection point B, respectively, and the center point of the proximal disc surface 114 is the point O, the included angle between the connection line AO and the connection line OB may be an acute angle, a right angle, or an obtuse angle. It can be understood that when the larger the angle between the connecting line AO and the connecting line OB is, the farther the connecting point B is from the connecting point a in the circumferential direction of the sealing disk 110, the mutual restriction between the connecting point a and the connecting point B by the pulling element 116 is more balanced than that in the case of smaller angle, so as to avoid that the fluid-blocking film 111 is easily torn and damaged due to the fact that the force applied to one connecting point is significantly larger than that applied to the other connecting point.

Example 3

The same parts of the occluding device of example 3 as those of example 2 are not described again. The difference between the two is mainly that in embodiment 3, referring to fig. 10 and 11, there are 5 connecting points between the pulling elements 116 and the proximal disc surface 114, and the pulling elements 116 are distributed in the shape of a pentagram in the sealing disc 110. Further, the 5 connection points are uniformly distributed centering on the center axis of the seal disk 110.

Taking the example of the connection of the pulling element 116 to the proximal disc surface 114, please refer to fig. 10 to 12 (for ease of understanding and viewing, a part of the braided wire is omitted from fig. 12, and only a part of the braided wire 118 required to wrap the pulling element 116 is shown), and the 5 connection points are a first connection point (corresponding to point 3 in fig. 12), a second connection point (corresponding to point 6 in fig. 12), a third connection point (corresponding to point 4 in fig. 12), a fourth connection point (corresponding to point 7 in fig. 12), and a fifth connection point (corresponding to point 5 in fig. 12) that are uniformly distributed circumferentially around the central axis of the sealing disc 110. Taking the traction piece 116 as a suture thread, for example, in cooperation with a suture needle for connecting the middle region of the flow blocking membrane 111 and the middle region of the proximal disk surface 114, one end of the traction piece 116 can be inserted into the needle from a quarter of the distance from the center of the sealing disk 110 (corresponding to point 1 in fig. 12), the suture needle with the suture thread can be penetrated into and through the flow blocking membrane 111 from the first side to the second side, and the tail of the suture thread is left on the first side of the flow blocking membrane 111; after the second side of the obstructing membrane 111 moves toward the preset first connection point by a distance of approximately 5mm to 8mm, the suture needle penetrates from the second side of the obstructing membrane 111 and penetrates back to the first side thereof (corresponding to point 2 in fig. 12); then at least one wrap of the at least one weaving wire 118 at the first connection point, preferably at the intersection of two weaving wires 118 (corresponding to point 3 in fig. 12); then moving towards a preset third connecting point, sequentially and respectively winding the third connecting point, a preset fifth connecting point, a preset second connecting point and a preset fourth connecting point in the same or similar way of winding the first connecting point, and enabling the wound suture needle to be positioned at a first side of the flow blocking film 111 (corresponding to a point 7 in fig. 12); and then fixedly attached to the rear portion of the retractor 116 and the needle removed, thereby forming the retractor 116 into the shape of a five-pointed star within the gland plate 110. The first to fifth connection points are all intersections of the filament, so that the positions of the portions of the traction pieces 116 connected at the intersections are relatively stable and are not prone to shifting. The portions of the pulling elements 116 at the 5 junctions of the sealing disc 110 are evenly drawn toward each other during sheath insertion, so that the pulling elements 116 do not tend to protrude outward from the proximal disc surface 114 of the sealing disc 110, thereby preventing thrombus formation. In addition, the traction piece 116 is attached to the disc surface of the sealing disc 110 in a pentagram shape, so that the supporting strength of the disc surface of the sealing disc 110 can be improved, and the attachment of the disc surface of the sealing disc 110 to the left atrial appendage portion is promoted.

In other embodiments, the proximal disc surface 114 in the above embodiments can be replaced by the distal disc surface, and the structure and function of the traction member 116, and the connection mode with the distal disc surface are the same or similar to those in the above embodiments, and will not be described herein again.

Further, in other embodiments, the proximal or distal stop of the seal disk 110 is a sleeve with a projection 117 facing the interior of the seal disk 110. The structure, function and other features of the protruding portion 117 are the same as those of embodiment 1, and are not described again.

The middle area of the near-end disk surface 114 or the far-end disk surface of the sealing disk 110 is connected with the middle area of the flow resisting membrane 111 through any one of the traction pieces 116, so that the force acting on the flow resisting membrane 111 is balanced when being transmitted to the edge of the flow resisting membrane 111, the flow resisting membrane 111 is not damaged, and the flow resisting membrane 111 cannot fall off from a woven net due to large partial stress, and in addition, when the sealing disk 110 is put into a sheath, the flow resisting membrane 111 is uniformly folded, the outer diameter after being folded is the smallest, and the sealing disk 110 can be conveniently inserted into the sheath and the sheath with a smaller size can be conveniently selected.

All possible combinations of the technical features of the above embodiments may not be described for the sake of brevity, but should be considered as within the scope of the present disclosure as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A plugging device comprises a sealing disc and a flow resisting film arranged in the sealing disc, wherein the sealing disc comprises a near-end disc surface and a far-end disc surface, and the flow resisting film is arranged between the near-end disc surface and the far-end disc surface; when one end of the sealing disc is far away from the other end of the sealing disc, the traction piece drives the middle area of the flow-resisting film to move along with the end part of the sealing disc so as to axially fold the flow-resisting film, the sealing disc further comprises a beam-converging piece arranged at the end part of the sealing disc, and a protruding part facing the inside of the sealing disc is arranged on the beam-converging piece; when the seal disk is expanded, the tip of the boss abuts the intermediate region of the flow-blocking membrane.

2. The occlusion device of claim 1, wherein the sealing disc is a mesh tube made of a plurality of wires, a portion of the traction element being wrapped around at least one wire of the proximal disc face or a middle region of the distal disc face.

3. The occlusion device of claim 2, wherein a portion of the pulling member wraps around at least one wire of a middle region of the proximal disc face or the distal disc face for at least two turns.

4. The occlusion device of claim 3, wherein the pulling member comprises a first section, a second section, and a third section connected in series; a part of the first section is wound around the middle area of the near-end disc surface or the far-end disc surface, a part of the third section penetrates through one side of the current-blocking film and penetrates back from the other side of the current-blocking film after a preset distance, and the second section is positioned between the current-blocking film and the near-end disc surface or the far-end disc surface; the end part of the first section of the traction piece is fixedly connected with the end part of the third section.

5. The occlusion device of claim 2 or 3, wherein the pulling member is connected to a plurality of connection points in a medial region of the proximal disc face or the distal disc face.

6. The occlusion device of claim 5, wherein there are two of said connection points that are symmetrical about a central axis of said sealing disk.

7. The occlusion device of claim 6, wherein the pulling member comprises a first section, a second section, and a third section connected in series; a part of the first section is wound around a first connection point of the middle area of the near-end disc surface or the far-end disc surface, a part of the second section is wound around a second connection point of the middle area of the near-end disc surface or the far-end disc surface, and a part of the third section penetrates through one side of the flow resistance film and penetrates back from the other side of the flow resistance film after being spaced by a preset distance; the end part of the first section of the traction piece is fixedly connected with the end part of the third section.

8. The occlusion device of claim 5, wherein there are 5 of said connection points, and said traction members are disposed in a five-pointed star configuration within said sealing disc.

9. The occlusion device of claim 8, wherein 5 of the connection points are a first connection point, a second connection point, a third connection point, a fourth connection point, and a fifth connection point circumferentially distributed about the central axis of the sealing disk; one end of the traction piece is sequentially and respectively wound around the first connection point, the third connection point, the fifth connection point, the second connection point and the fourth connection point and then is fixedly connected with the other end of the traction piece.