CN119214721A

CN119214721A - A blocking device and a blocking system

Info

Publication number: CN119214721A
Application number: CN202310786154.7A
Authority: CN
Inventors: 程晓阳; 陶晓博; 麻郑宇
Original assignee: Hangzhou Dinova EP Technology Co Ltd
Current assignee: Hangzhou Dinova EP Technology Co Ltd
Priority date: 2023-06-29
Filing date: 2023-06-29
Publication date: 2024-12-31

Abstract

The invention provides a plugging device and a plugging system comprising the same, wherein the plugging device is used for plugging a tissue defect, the plugging device comprises a distal plugging piece, the distal plugging piece is used for plugging a distal gap of the tissue defect, the distal plugging piece comprises a supporting part and a fitting part, the fitting part is used for fitting on a tissue, the supporting part is used for supporting the fitting part, and the hardness of the supporting part is larger than that of the fitting part. The hardness of the supporting part of the distal blocking piece is larger than that of the attaching part, the flexibility of the attaching part is larger than that of the supporting part, the anatomical structure of tissue defect can be well conformed, and the attaching performance and the flow blocking performance of the distal blocking piece are improved. The supporting part is used for supporting the attaching part, so that the attaching part is prevented from being deformed too much after attaching to the periphery of the tissue defect, and the attaching part is ensured to play a role in blocking at the far-side notch stably.

Description

Plugging device and plugging system

Technical Field

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

Background

In recent years, with advances in interventional therapy techniques, such as transcatheter heart valve replacement or repair, chest aortic aneurysm repair, or cardiac ablation, etc., it has been necessary to insert a catheter through an incision in the patient's skin and underlying tissue to access an artery or vein for surgery. After the operation, the catheter needs to be moved out of the blood vessel, so that the incision of the blood vessel into which the catheter is inserted must be closed. Because of the high blood pressure in the artery, the conventional methods of pressing, suturing, adhesive and the like take a long time to stop bleeding, unnecessary vascular deformation is easy to cause, and a good sealing effect is difficult to achieve.

In the 90 s of the 20 th century, percutaneous arteriovenous closure devices were introduced. The blood vessel can be quickly stopped by using the vascular closure device without pressing the blood vessel or with minimal pressing, and the vascular closure device is not affected by continuous anticoagulation. The application of the arteriovenous occlusion technology is the future arteriovenous hemostasis development direction, and the hemostasis time and the bedridden time are greatly shortened. On the basis, the pain of the patient and the strength of medical care are also relieved.

However, the arteriovenous sealing has very high requirements on the fitting property of the closure device and tissues, and the current arteriovenous closure device cannot be completely fitted with a vascular incision generally, so that the hemostatic effect is poor.

Disclosure of Invention

The embodiment of the invention provides a plugging device, which is used for plugging a tissue defect, and comprises a distal plugging piece, wherein the distal plugging piece is used for plugging a distal notch of the tissue defect and comprises a supporting part and a fitting part, the fitting part is used for fitting to the tissue, the supporting part is used for supporting the fitting part, and the hardness of the supporting part is larger than that of the fitting part.

Further, the laminating portion includes a first laminating portion and a second laminating portion, and the support portion, the first laminating portion, and the second laminating portion are laminated in a distal direction of the tissue defect to close a distal gap of the tissue defect.

Further, the first lamination part is arranged on the far side of the second lamination part, a penetrating hole is formed in the second lamination part, the plugging device comprises a fixing piece connected to the far side plugging piece, the fixing piece penetrates through the penetrating hole, one end of the fixing piece is connected to the first lamination part, the other end of the fixing piece is connected to the conveying device, in the release process of the plugging device, the near side of the second lamination part is limited to peripheral tissues of a far side notch, and the fixing piece pulls the supporting part to the near side, so that the supporting part, the first lamination part and the second lamination part are mutually laminated in the far side direction of the tissue defect.

Embodiments of the present application also provide an occlusion system comprising a delivery device for delivering and releasing the occlusion device at the tissue defect, and an occlusion device as described above.

The embodiment of the application also provides an occlusion system, which comprises a conveying device and the occlusion device, wherein the conveying device is used for pulling the supporting part proximally through the fixing piece after the distal occlusion piece is released from the distal end of the conveying device to the distal side of the tissue defect in the release process of the occlusion device, so that the supporting part, the first lamination part and the second lamination part are mutually laminated in the distal direction of the tissue defect.

The embodiment of the application also provides a plugging system, which comprises a conveying device and the plugging device, wherein the plugging device further comprises a proximal plugging piece arranged on the proximal side of the distal plugging piece, the proximal plugging piece is used for plugging a proximal notch of the tissue defect, the proximal plugging piece is connected with the fixing piece, the fixing piece comprises a knot arranged on the proximal side of the proximal plugging piece, and the conveying device is used for locking the knot on the proximal side of the proximal plugging piece so as to fix the distance between the proximal plugging piece and the distal plugging piece.

In the plugging device provided by the embodiment of the application, the hardness of the supporting part of the distal plugging piece is greater than that of the attaching part, and the flexibility of the attaching part is greater than that of the supporting part, so that the device can better conform to the anatomical structure of the tissue defect, and the attaching performance and the flow blocking performance of the distal plugging piece are improved. The supporting part is used for supporting the attaching part, so that the attaching part is prevented from being deformed too much after attaching to the periphery of the tissue defect, and the attaching part is ensured to play a role in blocking at the far-side notch stably.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic structural view of a plugging system according to a first embodiment of the present application;

FIG. 2 is a schematic illustration of the structure of the occlusion system of FIG. 1 for occluding a tissue defect;

FIG. 3 is a schematic view of the occlusion device of FIG. 1 shown in an occluded tissue defect;

FIG. 4 is a schematic view of the occluding device shown in FIG. 1 in a delivery state;

fig. 5 is a schematic view of the structure of the occlusion device shown in fig. 1 in a modified embodiment in a delivery state;

fig. 6 is a schematic structural view of an occlusion device according to a second embodiment of the present application;

Fig. 7 is a schematic structural view of an occlusion device according to a third embodiment of the present application;

fig. 8 is a schematic structural view of an occlusion device according to a fourth embodiment of the present application;

FIG. 9 is a schematic view of the occlusion device of FIG. 8 after release is completed;

Fig. 10 is a schematic structural view of the first laminated portion in fig. 8 in a modified embodiment;

Fig. 11 is a schematic structural view of the first laminated portion in fig. 8 in another modified embodiment;

Fig. 12 is a schematic structural view of an occlusion device according to a fifth embodiment of the present application;

Fig. 13 is a schematic structural view of a plugging system in a conveying state according to a fifth embodiment of the present application;

Fig. 14 is a schematic view of the closure system of fig. 13 in an initial stage in the released state;

FIG. 15 is a schematic illustration of the occlusion system of FIG. 13 in an intermediate stage in a released state;

FIG. 16 is a schematic illustration of the occluding device of FIG. 13 upon completion of release;

fig. 17 is a schematic structural view of a plugging system according to a sixth embodiment of the present application;

FIG. 18 is a schematic view of the fitting portion of FIG. 17;

fig. 19 is a schematic view of the bonding portion in fig. 18 in a modified embodiment;

fig. 20 is a schematic view of the bonding portion shown in fig. 17 in another modified embodiment;

FIG. 21 is a schematic view of the occlusion system of FIG. 17 in a delivery configuration;

FIG. 22 is a schematic view of the occlusion system of FIG. 17 in a delivery configuration at another angle;

fig. 23 is a schematic structural view of an occlusion device according to a seventh embodiment of the present application;

fig. 24 is a schematic structural view of an occlusion device according to an eighth embodiment of the present application;

fig. 25 is a schematic structural view of an occlusion device according to a ninth embodiment of the present application;

fig. 26 is a schematic structural view of an occlusion device according to a tenth embodiment of the present application;

fig. 27 is a schematic structural view of a plugging system in a conveying state according to a tenth embodiment of the present application;

FIG. 28 is a schematic view of the occlusion device of FIG. 26 after release is completed;

fig. 29 is a schematic structural view of an occlusion device according to an eleventh embodiment of the present application;

Fig. 30 is a schematic view of the occlusion device of fig. 29 after release is completed.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. The components of the embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the invention, as presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

It should be noted that the same or similar reference numerals and letters indicate similar items in the following figures, and thus, once an item is defined in one figure, no further definition or explanation thereof is necessary in the following figures.

In the description of the present invention, it should be noted that, if the terms "upper", "lower", "inner", "outer", and the like indicate an azimuth or a positional relationship based on the azimuth or the positional relationship shown in the drawings, or the azimuth or the positional relationship in which the inventive product is conventionally put in use, it is merely for convenience of describing the present invention and simplifying the description, and it is not indicated or implied that the apparatus or element referred to must have a specific azimuth, be configured and operated in a specific azimuth, and thus it should not be construed as limiting the present invention.

Furthermore, the terms "first," "second," and the like, if any, are used merely for distinguishing between descriptions and not for indicating or implying a relative importance.

It should be noted that the features of the embodiments of the present invention may be combined with each other without conflict.

Definition of paraphrasing:

Proximal and distal ends, along the path of delivery of the medical device, the medical device or component thereof is proximal at the end relatively adjacent the operator and distal at the end relatively remote from the operator. In particular, in an embodiment of the present application, there is provided a plugging system comprising a plugging device and a delivery device. The plugging device is used for plugging the tissue defect, and the conveying device is used for conveying and releasing the plugging device to the tissue defect. The distal end of the conveying device is connected with the proximal end of the plugging device along the conveying path of the plugging system, one end of the plugging device or a part thereof, which is closer to the conveying device, is the proximal end, one end of the plugging device, which is farther from the conveying device, is the distal end, and one end of the conveying device or a part thereof, which is closer to an operator, is the proximal end, and one end of the plugging device, which is farther from the operator, is the distal end.

Proximal and distal, along the path of delivery of the medical device, the medical device or side of the medical device where the components are relatively adjacent to or facing the operator is proximal and the side relatively away from or facing away from the operator is distal. In particular in the present application, the delivery device is used to connect the proximal end of the occlusion device from the proximal side of the occlusion device along the delivery path of the occlusion system, the side of the occlusion device or component thereof adjacent to or facing the delivery device is proximal and the side of the delivery device away from or facing away from the delivery device is distal, and the side of the delivery device or component thereof adjacent to or facing the operator is proximal and the side of the delivery device adjacent to or facing away from the operator is distal.

The terms "axial" or "axial direction" as used herein in the description and in the claims refer to the direction of the central axis of the device or component, or to the direction passing through the geometric center of the device or component and extending between the proximal and distal ends thereof. In the application, the conveying device and the plugging device are axially overlapped.

Radial, radial to axial space, of the device or component.

Circumferential refers to the circumferential direction of the device or component, i.e., the direction about the axis of the device or component. The circumferential direction is perpendicular to the axial direction and perpendicular to the radial direction.

The "circumferential" and "axial" and "radial" together constitute three orthogonal directions of the device or component.

The plugging system provided by the embodiment is used for plugging tissue defects, and can be used for plugging tissue defects such as organism blood vessel puncture (such as arterial blood vessel puncture and venous blood vessel puncture), aortic dissection rupture, heart defects (such as patent foramen ovale, atrial septal defect, ventricular septal defect, arterial catheter patent and the like). The following embodiments describe the specific structure of the occlusion system as it is used to occlude a vascular puncture, and it will be appreciated that the occlusion system provided by the embodiments of the present application may also be used to occlude other biological tissue defects, whether mentioned above or not.

First embodiment

Referring to fig. 1 to 4, the present embodiment provides a plugging system for plugging a tissue defect, which includes a delivery device 900 and a plugging device 101A, wherein the delivery device 900 is used for delivering and releasing the plugging device 101A at the tissue defect 1005, the plugging device 101A includes a distal plugging member for plugging a distal gap 1006 of the tissue defect 1005, the distal plugging member includes a supporting portion 100 and a fitting portion 200, the fitting portion 200 is used for fitting to the tissue, the supporting portion 100 is used for supporting the fitting portion 200, and the supporting portion 100 has a hardness greater than that of the fitting portion 200.

The plugging system provided by the embodiment of the application is used for plugging the tissue defect 1005, the distal plugging piece of the plugging device 101A can be used for plugging the distal notch 1006 of the tissue defect 1005, and the conveying device 900 is used for conveying and releasing the plugging device 101A at the tissue defect 1005, so that an operator can conveniently plug the tissue defect 1005 by using the distal plugging piece, the operation is convenient, and the operation time is saved.

As shown in fig. 2 to 3, in the present embodiment, the tissue defect 1005 is a blood vessel puncture, the tissue defect 1005 has two side notches, namely, a distal notch 1006 and a proximal notch 1007, the distal notch 1006 is connected to the inner wall of the blood vessel 1002, and the proximal notch 1007 is connected to the outer wall of the blood vessel.

A puncture channel 1003 is formed between the tissue defect 1005 and the biological body surface 1001, the puncture channel 1003 being for a treatment device to pass through to form an interventional channel or a delivery channel. The distal end of the delivery device 900 is used to load the occluding device 101A, the occluding device 101A is used to reach the tissue defect from the biological body surface 1001 along the puncture passageway 1003 and into the blood vessel 1002 under the pushing action of the distal end of the delivery device 900, and the distal end of the delivery device 900 is used to release the distal occluding component of the occluding device 101A within the blood vessel 1002 to facilitate the distal occluding component to occlude the distal notch 1006 of the tissue defect 1005.

In the distal blocking member, the hardness of the supporting portion 100 is greater than that of the attaching portion 200, and the flexibility of the attaching portion 200 is greater than that of the supporting portion 100, so that the distal blocking member can better conform to the anatomical structure of the tissue defect 1005, and the attaching performance and the flow blocking performance of the distal blocking member are improved. The supporting part 100 is used for supporting the attaching part 200, so that the excessive deformation of the attaching part 200 after attaching the periphery of the tissue defect 1005 is avoided, and the attaching part is ensured to play a role in blocking at the distal notch 1006 stably.

Specifically, the supporting portion 100 is disposed on the distal side of the fitting portion 200, and after the distal blocking member is released and blocked in the distal notch 1006, the fitting portion 200 is pressed at the distal notch 1006 by the supporting portion 100. The support portion 100 and the attaching portion 200 are stacked at the distal notch 1006, so that a multi-layer structure for blocking the distal notch 1006 is formed, and compared with a single-layer blocking structure, the multi-layer structure formed by the distal blocking member can prevent excessive gaps between the distal blocking member and a tissue wall (such as a blood vessel wall), thereby reducing the risk of blood leakage and improving the blocking performance.

Since the hardness of the supporting portion 100 is greater than that of the attaching portion 200, the supporting portion protects at least part of the surface of the distal side of the attaching portion from being scoured and deformed by blood flow, so that the stable form of the attaching portion 200 in blood flow is ensured, endothelialization instrument is facilitated, and the risk of vascular stenosis and thrombus formation is reduced.

In addition, as shown in fig. 1, the occluding device 101A includes a securing member 300, one end of the securing member 300 is connected to the distal occluding member and the other end is connected to the delivery device 900. After release of the occluding device 101A is completed, the securing member 300 is used to secure to tissue proximal to the distal occluding member. The fixing element 300 comprises a wire body, the fixing element 300 is used for pulling the far-side sealing element so as to realize the connection between the conveying device 900 and the sealing device 101A, on the other hand, the fixing element 300 passes through the jointing part 200 to be connected with the supporting part 100, after the fixing element 300 is fixed on a tissue, under the action of the fixing element 300 pulling the supporting part 100, the supporting part 100 can effectively press the jointing part 200 to be jointed with the periphery of the far-side notch 1006, the sealing hemostasis effect is realized, the hardness of the supporting part 100 is larger than that of the jointing part 200, and the supporting part is favorable for being kept at the far side of the tissue defect 1005 under the pulling effect of the fixing element 300. If the support portion 100 is soft, the attachment portion 200 and the support portion 100 may be pulled to the near side of the tissue defect 1005 (the outside of the wall of the blood vessel 1002) by the pulling action of the fixing member 300, and thus the hemostasis function may not be achieved. Similarly, if the distal occluding component is not provided with the supporting portion 100, the conformable portion 200 is relatively flexible and the conformable portion 200 is also relatively easily pulled by the securing component 300 to the proximal side of the tissue defect 1005, thereby failing to provide hemostasis.

As shown in fig. 1, the attaching portion 200 may be provided with penetrating holes 202 through which the fixing members 300 pass, and the shape and number of the penetrating holes 202 may be set as required.

The supporting portion 100 and the attaching portion 200 may be made of at least one of a non-degradable material, a degradable biological material, and a degradable polymer material.

The supporting portion 100 and the attaching portion 200 may be made of at least one of a degradable material and a non-degradable material, respectively, and the supporting portion 100 and the attaching portion 200 may be made of the same material or different materials, without the material used for the supporting portion 100 and the material used for the attaching portion 200 being in a binding relationship.

The support portion and the attaching portion may be made of the following materials:

Non-degradable materials include, but are not limited to, polypropylene, aromatic polyester, polytetrafluoroethylene;

Degradable biological materials include, but are not limited to, collagen and like materials (such as collagen-rich porcine small intestine submucosa material), polyhydroxyalkanoates (PHA);

Degradable polymeric materials include, but are not limited to, polyglycolic acid (PGA), polyethylene glycol (PEG), polylactic acid (PLA), polylactic acid-polycaprolactone copolymer (PLCL), polylactic acid-polyglycolic acid copolymer (PLGA), hydrogels, polyvinyl alcohol (PVA).

In this embodiment, the supporting portion 100 and the attaching portion 200 are made of degradable materials, so that after a degradation period, the supporting portion 100 and the attaching portion 200 are degraded in blood vessels and can be completely absorbed, foreign matters are not left in the blood vessels, long-term vascular patency can be maintained, the risk of thromboembolism is reduced, long-term complications and adverse effects caused by the permanent retention of the plugging device in the body can be eliminated, and at the same time, the administration period of the anti-thrombus medicament is shortened.

In the present embodiment, the supporting portion 100 and the attaching portion 200 are made of different materials due to different hardness. The supporting portion 100 and the attaching portion 200 are of a split structure, i.e. the supporting portion 100 and the attaching portion 200 are discrete components. In other embodiments, the supporting portion 100 and the attaching portion 200 may be integrally formed, or may be integrally formed and fixedly connected.

Further, the attaching portion 200 swells when absorbing water, that is, the attaching portion 200 swells when entering into a living body to contact with body fluid, so that flexibility and elasticity are increased, the peripheral tissue of the distal notch 1006 is more easily attached and blocked, and the blocking and hemostasis effects are better. The fitting portion 200 may include at least one of collagen, hydrogel, and polyvinyl alcohol (PVA) to achieve water swelling. In some embodiments, the laminating portion 200 includes a collagen material, so that the laminating portion is soft, is convenient for laminating tissues, is easy to absorb water and expand, has good blocking effect, and is degradable. Preferably, the attaching portion 200 is made of a collagen-rich porcine small intestine submucosa material, and is biodegradable, and the material is soft due to volume expansion after water absorption.

In the present embodiment, the support portion 100 has a sheet shape, and may have a planar sheet shape as shown in the figure, or a curved sheet shape. The end surface of the support 100 may have a circular, oval, square, hexagonal, capsule-shaped, or other regular or irregular shape.

The attachment portion 200 is relatively soft, has a certain elasticity, is irregularly shaped in this embodiment, and occupies a certain thickness in the axial direction of the occlusion device 101A, so as to be able to better attach to the tissue at the distal notch 1006 and block the blood flow. In other embodiments, the bonding portion 200 may have a sheet shape. It will be appreciated that in some embodiments, the proximal and distal faces of the conformable portion 200 may be circular, oval, square, hexagonal, capsule, drop-shaped, or other regular or irregular shapes, respectively.

As shown in fig. 3, after the distal blocking member is released and blocked in the distal notch 1006, the conforming portion 200 is blocked between the support portion 100 and the tissue, preventing the support portion 100 from damaging the tissue.

In some embodiments, in a natural state (state in which the occluding device 101A is not subjected to the force of the delivery device 900 or tissue, and is naturally distended), the radial dimension of the conforming portion 200 is greater than the supporting portion 100, thereby ensuring that the conforming portion 200 is capable of being occluded between the supporting portion 100 and the tissue after release of the occluding device 101A is complete. In some embodiments, the fit portion 200 expands in volume after absorbing body fluid after entering a living body, and has enhanced flexibility and elasticity, and the radial dimension of the fit portion 200 is larger than that of the support portion 100 under the pressing action of the support portion 100, so that the fit portion 200 can be blocked between the support portion 100 and the tissue.

The fixing member 300 includes a wire, and in this embodiment, the fixing member 300 is in a linear shape and is inserted into the insertion hole 202 of the attaching portion 200. The securing member 300 may be a suture. The fixing member 300 may be a non-degradable suture, which may be a polypropylene suture or the like, and the fixing member 300 may also be a degradable suture, such as a collagen suture, a catgut, a glycolic acid suture or the like, which may be an absorbable thread. In other embodiments, the fixing member 300 may be a member capable of passing through the penetration hole 202 other than the wire body. In some embodiments, anchor 300 includes other components for securing the ends of a suture that are coupled to the suture.

The fixation member 300 is for fixation to tissue proximal to the distal occluding member. In this embodiment, the anchor 300 is a suture that is threaded through the delivery device 900 with two free ends of the suture connected to operating handles (not shown) of the delivery device that are capable of securing the suture to tissue proximal of the distal occlusion, such as anchor 300 being capable of being secured to peripheral tissue of tissue defect 1005 proximal of the distal occlusion, i.e., to the wall of vessel 1002. Referring to fig. 3, in this embodiment, a fixture 300 can be secured to a biological body surface 1001 proximal to a distal closure under the control of an operating handle. Specifically, the fixing member 300 forms a knot 302 in the biological body surface 1001, thereby achieving fixation to the biological body surface 1001. It will be appreciated that the securing member 300 may be secured to the tissue proximal to the distal occluding member by tying knots, suturing, additional provision of a locking member engaged therewith, or the like.

As shown in fig. 1, the attaching portion 200 is provided with one through hole 202. The attaching portion 200 is provided with a through hole 202 in a central region (region surrounded by an edge) thereof, the through hole 202 being a through hole penetrating in a thickness direction of the attaching portion 200, and the through hole 202 penetrating in an axial direction of the attaching portion 200 when the plugging device 101A is implanted in a living body. As shown in fig. 1, the through hole 202 is circular, and in other embodiments, the through hole 202 may have other shapes, such as oval, bar, etc., as desired. The size of the through hole 202 needs to be matched with that of the fixing piece 300 so as to allow the fixing piece 300 to pass through, ensure that the fixing piece 300 can slide smoothly in the through hole 202, avoid the through hole 202 from being oversized, and reduce the possibility that blood flows through a gap between the through hole 202 and the fixing piece 300 to form blood flow.

The fixing member 300 is coupled to the supporting portion 100 through the penetration hole 202 of the fitting portion 200. One end of the fixing member 300 is fixedly coupled to the supporting portion 100. The fixing member 300 may be fixed to the supporting portion 100 by a conventional manner such as knotting, sewing, bonding, welding, or using other locking members. In other embodiments, the fixing member 300 is movably connected to the supporting portion 100.

In some embodiments, the proximal end surface of the support 100 is provided with a passable ring, and the securing member 300 may be secured to the passable ring, such as by tying, welding, adhesive, or the like.

Referring to fig. 4, in the delivery state (state in which the occlusion device 101A is positioned inside the delivery device 900), the supporting portion 100 and the attaching portion 200 are disposed at intervals in the delivery device 900, specifically, at intervals in the axial direction of the delivery device, and the attaching portion 200 is released after the supporting portion 100 is released to the distal side of the tissue defect 1005.

In some alternative embodiments, referring to fig. 5, fig. 5 illustrates an alternative embodiment of the occluding device 101A of fig. 4 in a delivery state.

In the conveying state, in the conveying apparatus 900, the supporting portion 100 and the bonding portion 200 at least partially overlap in the axial direction of the conveying apparatus 900, that is, the supporting portion 100 and the bonding portion 200 may partially overlap in the axial direction of the conveying apparatus 900 or overlap entirely (the supporting portion 100 is disposed within the axial range of the bonding portion 200 or the bonding portion 200 is disposed within the axial range of the supporting portion 100). The support portion 100 and the attaching portion 200 are at least partially overlapped in the axial direction of the conveying device 900. As shown in fig. 5, the attaching portion 200 is wrapped around at least a portion of the surface of the supporting portion 100, so that the length of the fixing member 300 therebetween is reduced as much as possible, and the two members are more easily attached to each other during the releasing process in a stacking manner in which the two members are substantially held in the conveying device 900 after the releasing.

In particular, in this embodiment, before the distal blocking member is loaded onto the conveying device 900, the fixing member 300 between the supporting portion 100 and the attaching portion 200 may be tightened, so that the distance between the supporting portion 100 and the attaching portion 200 is smaller, after the distal blocking member is loaded onto the conveying device 900, particularly in a conveying state, the supporting portion 100 and the attaching portion 200 are at least partially overlapped in the axial direction of the conveying device 900, accordingly, the supporting portion 100 and the attaching portion 200 may also be stacked on each other in the radial direction of the conveying device 900, the supporting portion 100 and the attaching portion 200 are close to each other, and the difficulty in attaching the supporting portion 100 to the compression attaching portion 200 in the releasing process is reduced.

In the delivery device 900, if the support portion 100 and the attaching portion 200 are disposed at a distance from each other, the fixing member 300 therebetween is long, and the distal blocking member is likely to have different stacked states during in-vivo folding.

For example, in the release process, the support part 100 is easy to rotate relative to the fitting part 200 under the scouring action of blood flow, the fixing piece 300 between the support part 100 and the fitting part 200 is easy to twist, the fixing piece 300 is difficult to pull and slide in the penetrating hole 202 of the fitting part 200, so that the support part 100 cannot press the fitting part 200, or after the support part 100 presses the fitting part 200, the support part 100 is difficult to press the fitting part 200 in a preset direction, a large number of edges of the fitting part 200 are exposed outside the periphery of the support part 100, the plugging performance of the plugging device 101A is affected, the area of the fitting part 200 exposed to blood flow is increased, the endothelialized area is larger, and the risk of thrombus formation due to vascular stenosis is high.

Second embodiment

Referring to fig. 6, the present embodiment provides an occlusion device 101B, where the occlusion device 101B is used for occluding a tissue defect, and the occlusion device 101B includes a supporting portion 100, a fitting portion 200, and a fixing member 300 connected to the supporting portion 100 through the fitting portion 200. The occlusion device 101B may be used with the delivery device 900 provided in the first embodiment to obtain a corresponding occlusion system, and the delivery device 900 may deliver and release the occlusion device 100B. The main difference between the plugging device 101B in this embodiment and the plugging device 101A shown in fig. 1 is that the structure of the attaching portion 200 is different, and the plugging device 101B in this embodiment is the same as the plugging device 101A provided in the first embodiment, please refer to the first embodiment, and a detailed description is omitted herein.

In the present embodiment, the attaching portion 200 has a truncated cone shape, and the attaching portion 200 includes a distal end surface 204 facing the supporting portion 100, a proximal end surface 205 facing away from the supporting portion 100, and a side wall 206 connecting the proximal end surface 205 and the distal end surface 204. The area of the proximal surface 205 of the attachment portion 200 is larger than that of the distal surface 204, and the sidewall 206 is inclined relative to the distal surface 204, so that the sidewall 206 is inclined relative to the wall of the blood vessel 1002 after the distal surface 204 attaches to and occludes the tissue defect 1005, which is beneficial to reducing the resistance of the sidewall 206 to blood flow, reducing the scouring action of the blood flow on the attachment portion 200, and reducing the probability of deformation and thrombus formation of the attachment portion 200.

Third embodiment

Referring to fig. 7, fig. 7 is a schematic structural diagram of an occlusion device 101C according to a third embodiment. The occlusion device 101C provided in the third embodiment includes a support part 100, a fitting part 200, and a fixing member 300 connected to the support part 100 through the fitting part 200. The occlusion device 101C may be used with the delivery device 900 provided in the first embodiment to obtain a corresponding occlusion system, and the delivery device 900 may deliver and release the occlusion device 100C. The primary difference between the occluding device 100C and the occluding device 100B is that the support 100 in the occluding device 100C is arched and the attachment configuration of the anchor 300 to the distal occluding device is different.

The supporting portion 100 is arched, particularly in a natural state (as shown in fig. 7), the surface of the supporting portion 100 is provided with a base line, the position of the base line can be set on the surface of the supporting portion 100 according to requirements, and the portions on two sides of the base line in the supporting portion 100 extend gradually distally, so that the supporting portion 100 protrudes (arches) proximally at the position of the base line, and when the supporting portion 100 is plugged into the distal notch 1006 of the tissue defect 1005, the supporting portion can be conveniently matched with the inner wall of the blood vessel 1002 with the arc-shaped periphery of the distal notch 1006, the distance between the periphery of the supporting portion 100 and the wall of the blood vessel 1002 is reduced, the pressing force of the edge of the supporting portion 100 to the attaching portion 200 and the wall of the blood vessel 1002 is improved, and the plugging performance is improved.

In the present embodiment, the attaching portion 200 is provided with a plurality of penetrating holes 202, and the supporting portion 100 is provided with penetrating holes 102 through which the fixing members 300 are penetrated. Specifically, the support portion 100 is provided with two through holes 102 penetrating in the thickness direction thereof. The fixing member 300 passes through the two passing holes.

In the assembly process, one end of the fixing member 300 passes through one of the through holes 202 of the fitting portion 200, passes through one of the through holes 102 of the supporting portion 100 in the distal direction, passes through the other of the through holes 202 of the supporting portion 100 in the proximal direction, and passes through the other of the through holes 202 of the fitting portion 200 in the proximal direction, thereby completing the assembly between the fixing member 300 and the distal blocking member.

It should be noted that, the two through holes 102 on the supporting portion 100 are disposed on the base line of the supporting portion 100 that is in an arch shape, that is, the two through holes 102 are disposed at the position where the supporting portion 100 protrudes proximally, so that after the fixing member 300 is tightened, a portion of the fixing member 300 located on the distal side of the supporting portion 100 (a portion between the two through holes 102) is beneficial to be attached to the distal end face of the supporting portion 100, so that the portion of the fixing member 300 located on the distal side of the supporting portion 100 is prevented from suspending to block blood flow, and the risk of thrombus formation is reduced.

Fourth embodiment

Referring to fig. 8 to 9, the present embodiment provides an occlusion device 101D, where the occlusion device 101D includes a support portion 100, a fitting portion 200, and a fixing member 300 passing through the fitting portion 200 and connecting the support portion 100. The occlusion device 101D may be used with the delivery device 900 provided in the first embodiment to obtain a corresponding occlusion system, and the delivery device 900 may be used to deliver and release the occlusion device 100D. The occluding device 101D in the present embodiment is mainly different from the occluding device 100C in the third embodiment of fig. 7 in that the attaching part 200 includes a first laminated part 210 and a second laminated part 220, and the first laminated part 210 and the second laminated part 220 are laminated in a distal direction of the tissue defect 1005 to occlude a distal notch 1006 of the tissue defect.

The distal direction of tissue defect 1005 may refer to the distal direction of distal notch 1006, i.e., the direction pointing from distal notch 1006 toward the central axis of blood vessel 1002, or may refer to the distal direction of proximal notch 1007, i.e., the direction pointing from proximal notch 1007 toward the central axis of blood vessel 1002.

The first lamination portion 210 and the second lamination portion 220 are configured to be laminated in a distal direction of the tissue defect 1005, so that the first lamination portion 210, the second lamination portion 220, and the support portion 100 form a three-layer structure for sealing the distal notch 1006, and compared with the two-layer sealing structure formed by the bonding portion 200 and the support portion 100 in the foregoing embodiment, the number of layers of the bonding portion 200 with higher flexibility is increased, and the tissue wall (such as a blood vessel wall) can be better bonded, thereby reducing the risk of blood leakage and improving the sealing performance.

In the present embodiment, the first lamination portion 210 and the second lamination portion 220 are made of different sheets, that is, the first lamination portion 210 and the second lamination portion 220 are of separate structures and each has a sheet shape.

Further, in the present embodiment, as shown in fig. 8, in a natural state (i.e., a state in which the occlusion device 101D is fully expanded without an external force), the first lamination portion 210 and the second lamination portion 220 have the same structure and each have a planar sheet shape.

The first and second lamination portions 210 and 220 are softer and more flexible than the support portion 100. In the delivery state (where the occluding device 100 is positioned within the lumen of the delivery device 900 (fig. 4 or 5)), the first and second layered portions 210, 220 may be curved under radial compression of the delivery device 900 to facilitate advancement into a living being in a smaller diameter state. Specifically, in the conveying apparatus, the first lamination portion 210 and the second lamination portion 220 may each have an arch shape. In other embodiments, both the first lamination portion 210 and the second lamination portion 220 may be curved in at least a partially rolled shape, i.e., the first lamination portion 210 and/or the second lamination portion 220 may be curved in a fully rolled shape.

In some embodiments, at least one of the first lamination portion 210 and the second lamination portion 220 is identical in its natural and transport state, i.e., at least one of the first lamination portion 210 and the second lamination portion 220 is unchanged in both states.

As shown in fig. 8, in the present embodiment, the shapes and sizes of the first lamination portion 210 and the second lamination portion 220 are consistent, so that the edge shape is regular after the lamination portion 200 is completely folded, and the edge delamination is obvious after the lamination portion 200 is folded due to the difference of the shapes of the lamination portions, which affects the normal blood flow velocity.

In this embodiment, the first lamination portion 210 and the second lamination portion 220 are each rectangular, and include a long side with a relatively long length and a wide side with a relatively short length, that is, each lamination portion has different radial dimensions in at least two directions.

In some embodiments, each of the stacks may be alternatively arranged in a square, a circle, an oval, a racetrack, a similar oval (fig. 10), or some irregular shape (such as shown in fig. 11). As shown in fig. 10, under the condition of keeping a large enough blocking area, the four-corner rounding design can weaken the scouring action of the blood flow on the first lamination portion 210, the edge of the first lamination portion 210 is not easy to tilt, and the blocking effect is good. As shown in fig. 10 and 11, the edges of the first lamination portion 210 are each circular arcs, so that the fluid resistance can be further reduced. The two long sides are longer than the two short sides, so that the problem that the effective plugging area is reduced due to the fact that the edge of the first lamination part 210 is invalid due to long-time blood flushing is avoided. The modified structure of the first laminated portion 210 in fig. 10 and 11 can be applied to other laminated portions without contradiction.

The two through holes 202 provided on the surfaces of the first and second lamination portions 210 and 220, respectively, are provided in the transverse direction thereof along or parallel to the long side thereof and in the longitudinal direction thereof along or parallel to the wide side thereof. In some embodiments, two through holes 202 provided on the surfaces of the first and second lamination portions 210 and 220 are provided along the longitudinal direction thereof or along an oblique direction between the lateral and longitudinal directions.

The fixing member 300 is inserted into the insertion hole 102 and the insertion hole 202, one end of the fixing member 300 is connected to the supporting portion 100, and the other end of the fixing member 300 is connected to the conveying device 900.

During release of the occluding device 101D, after the distal occluding component is released from the distal end of the delivery device 900 to the distal side of the tissue defect 1005, the proximal side of the second layered portion 220 is restrained against the peripheral tissue of the distal notch 1006 and the delivery device 900 is used to pull the support 100 proximally through the securing component 300 such that the support 100, the first layered portion 210, and the second layered portion 220 are layered on each other in the distal direction of the tissue defect 1005.

It is understood that in the first to third embodiments in which the attaching portion 200 has a one-piece structure, the conveying device 900 may release the supporting portion 100 and the attaching portion 200 in the same manner. Specifically, taking the first embodiment as an example, in the release process of the occlusion device 101A, after the distal occlusion member is released from the distal end of the delivery device 900 to the distal side of the tissue defect 1005, the proximal side of the attaching portion 200 is limited to the peripheral tissue of the distal notch 1006, and the fixing member 300 is controlled by the delivery device 900 to pull the supporting portion 100 proximally, so that the supporting portion 100 and the attaching portion 200 are stacked on each other in the distal direction of the tissue defect 1005. In other embodiments, an operator (e.g., physician) may move support 100 proximally by directly pulling on fastener 300, such that support 100 engages abutment 200, and support 100 and abutment 200 are stacked on top of each other in the distal direction of tissue defect 1005.

Fifth embodiment

Referring to fig. 12 to 16, a plugging device 100E is provided in a fifth embodiment of the present application, where the plugging device 101E can be used with the delivery device 900 provided in the first embodiment to obtain a corresponding plugging system, and the delivery device 900 can deliver and release the plugging device 100E.

The occlusion device 101E includes a support 100, a conformable segment 200, and a mount 300 connected between the support 100 and the delivery device 900 through the conformable segment 200. The occluding device 101E in the present embodiment is mainly different from the occluding device 100D in the fourth embodiment in that the first laminated portion 210 and the second laminated portion 220 in the bonded portion 200 are formed by folding the same sheet, that is, the first laminated portion 210 and the second laminated portion 220 are formed by folding the bonded portion 200 in a sheet shape.

Specifically, the sheet is the attaching portion 200, that is, the attaching portion 200 is a sheet, and the attaching portion 200 is folded to obtain the first lamination portion 210 and the second lamination portion 220, and the supporting portion 100, the first lamination portion 210, and the second lamination portion 230 are configured to be laminated in the distal direction of the tissue segment 1005.

It will be appreciated that the first lamination portion 210 and the second lamination portion 220 are formed by folding the lamination portion 200, and in this embodiment, different portions of the lamination portion 200 are folded to form a multi-layer sealing structure during the release of the lamination portion 200.

Specifically, the lamination portion 200 is a sheet, and the lamination portion 200 includes a first lamination portion 210 and a second lamination portion 220, and the first lamination portion 210 is disposed on a distal side of the second lamination portion 220. During distal occlusion release, particularly during proximal pulling of the anchor 300 against the support portion 100, the proximal side of the second lamination portion 220 is constrained to the tissue surrounding the distal gap 1006 of the tissue defect 1005, and proximal movement of the support portion 100 pushes the first lamination portion 210 toward the second lamination portion 220 and causes the first lamination portion 210 and the second lamination portion 220 to collapse upon each other, the support portion 100, the first lamination portion 210, and the second lamination portion 220 being stacked in a distal direction of the tissue defect 1005. The dashed lines in fig. 12 represent folds that are formed after the folding process is completed, it being understood that the folds are for illustration and may be distinguished from the shape and location of the folds that were actually produced. The fold line divides the bonding portion 200 into a plurality of laminated portions including a first laminated portion 210 and a second laminated portion 220, one side of one of the plurality of fold lines being the first laminated portion 210 and the other side being the second laminated portion 220. As shown in fig. 12, in the present embodiment, the lamination portion 200 is folded to obtain a plurality of folds, and accordingly a plurality of lamination portions divided by folds are obtained, and in other embodiments, the lamination portion 200 may be formed with other numbers of folds, for example, one number of folds is formed, and the folds divide the lamination portion 200 into the first lamination portion 210 and the second lamination portion 220.

In the present embodiment, in the course of pulling the supporting portion 100 proximally by the fixing member 300, the supporting portion 100 moves proximally to push the first lamination portion 210 toward the second lamination portion 220 and to cause the first lamination portion 210 and the second lamination portion 220 to fold with each other. In alternative embodiments, rather than pulling on the fixture 300 via the delivery device 900, the fixture 300 may be pulled by an operator (e.g., a physician) or other device.

Further, in the present embodiment, during the releasing process, the attaching portions 200 are mutually folded under the pulling action of the fixing member 300, preferably, the first stacking portion 210 and the second stacking portion 220 in the attaching portion 200 are both provided with the through holes 202, the through holes 202 formed in the same stacking portion are a set of through holes 202, and the crease is located at a position between different sets of through holes 202. The fixing member 300 is configured to be inserted into the insertion hole 202 and to be capable of sliding in the insertion hole 202, thereby tightening and folding the fitting portion 200. In some embodiments, the first lamination portion 210 is provided with a penetrating ring or the like to achieve connection with the fixing member 300.

As shown in fig. 13 to 16, in the conveyance state, the first lamination portion 210 and the second lamination portion 220 are not folded with each other along the crease. In the initial stage of the released state, i.e., when the conformable portion 200 is released distal to the tissue defect, the first and second laminate portions 210, 220 are not folded over each other along the crease without pulling on the fastener 300. In the releasing process of the blocking device 101E, in the middle stage of the releasing state, that is, in the process of pulling the fixing element 300, the proximal side of the second lamination portion 220 is limited to the peripheral tissue of the distal notch 1006 of the tissue defect 1005, the fixing element 300 drives the first lamination portion 210 to move proximally, and the through hole 202 in the first lamination portion 210 gradually approaches the through hole 202 in the second lamination portion 220 until the through hole 202 of the first lamination portion 210 and the through hole 202 of the second lamination portion 220 are aligned in a lamination manner in the distal direction of the distal notch 1006, and are mutually communicated, and the surfaces of the first lamination portion 210 and the second lamination portion 220 facing each other are attached together, at this time, the first lamination portion 210 and the second lamination portion 220 complete the folding process.

The through holes 202 on the distal closure are divided into a plurality of groups, wherein one group of through holes 202 is disposed in the first lamination portion 210, and one group of through holes 202 is disposed in the second lamination portion 220. It will be appreciated that as shown in fig. 12, the conformable portion 200 may also be configured to be laminated to each other with the first and second laminating portions 210, 220 and to seal off the distal side of the tissue defect 1005, such as the third and fourth laminating portions. In this embodiment, the first lamination portion 210 is disposed at the distal-most end of the distal closure, and the second lamination portion 220 is disposed adjacent to the first lamination portion 210. It is understood that the first lamination portion 210 may not be disposed at a distal end of the first lamination portion 210, and the second lamination portion 220 may be disposed at a distance from the first lamination portion 210, with other lamination portions interposed therebetween.

In this embodiment, the number of the through holes 202 in each group is 2, and the 2 through holes 202 in each group are arranged along the direction perpendicular to the axis of the distal plug, and in other embodiments, the number and arrangement manner of the through holes 202 in each group may be selected according to actual needs.

Definition:

in the unfolded state, all the laminated parts are not folded along the crease formed after folding, as shown in fig. 12 and 13;

In the fully folded state, all the laminated parts are folded along the crease formed after folding, the surfaces of the adjacent laminated parts facing each other are fully attached, or the gap between the surfaces of the adjacent laminated parts facing each other is small, as shown in fig. 16;

the semi-folded state is a state between the unfolded state and the fully folded state. As shown in fig. 17, the adjacent laminated portions are folded along the fold lines formed after folding to form a certain angle, such as 90 degrees or other angles, so that the laminated portions are arranged in a zigzag or wavy shape, and the adjacent laminated portions are not fully attached to each other, so that a relatively obvious gap is formed. Or part of the lamination parts are completely bonded with the mutually facing surfaces of the adjacent lamination parts, the mutually facing surfaces of the other lamination parts and the adjacent lamination parts are not completely bonded, and a relatively obvious gap is formed.

In the present embodiment, as shown in fig. 12 and 13, in both the natural state of the occlusion device 101E and the transport state of the occlusion device 101E, no crease is formed in the attaching portion 200, that is, neither the first laminated portion 210 nor the second laminated portion 220 is folded along the crease formed after folding. That is, in both the natural state and the transport state, the bonding portion 200 is unfolded. As shown in fig. 14 to 16, the occlusion device 101E performs a folding process of the fitting portion 200 during the release process. After the release is completed, as shown in fig. 16, the attaching portion 200 is in a fully folded state, and all the laminated portions are folded along the crease formed after the folding, and the surfaces of the adjacent laminated portions facing each other are fully attached.

In the present embodiment, the bonding portion 200 has a rectangular sheet shape. In some other embodiments, the bonding portion 200 may also have an oval sheet shape, or the multiple stacked portions in one bonding portion 200 may have a uniform structure, and may all have a racetrack shape, a hexagonal shape, a similar oval shape, or other regular or irregular shapes. A recess extending in the axial direction of the bonding portion 200 is formed between the adjacent laminated portions, so that the adjacent laminated portions can be folded with each other.

In the present embodiment, as shown in fig. 13, the attaching portion 200 has flexibility when not absorbing water, and is curved in a curved shape by the binding action of the conveying device 900. In some embodiments, the attaching portion 200 is configured in the conveying device 900 in accordance with a configuration outside the conveying device 900, for example, the attaching portion 200 is in a long strip shape and can be accommodated in the conveying device 900 in a natural state, and is not bound by the conveying device 900.

Sixth embodiment

Referring to fig. 17 to 22, a plugging system according to a sixth embodiment of the present application comprises a plugging device 100F and a conveying device 900. The occlusion device 101F includes a support 100, a conformable segment 200, and a mount 300 connected between the support 100 and the delivery device 900 through the conformable segment 200. The occluding device 101F in the present embodiment is mainly different from the occluding device 100E in the fifth embodiment in that a folded portion 215 is formed between the first laminated portion 210 and the second laminated portion 220 in the attaching portion 200, and the folded portion 215 facilitates folding of the first laminated portion 210 and the second laminated portion 220 in the distal direction of the tissue defect 1005. During the proximal pulling of the support portion 100 by the fixing member 300, the support portion 100 pushes the first and second lamination portions 210 and 220 to be folded with each other along the folding portion 215. In this embodiment, the delivery device 900 may pull the support 100 proximally through the anchor 300, and in a modified embodiment, the anchor 300 may be pulled through an operator (e.g., a physician) or other device without pulling the anchor 300 through the delivery device 900.

The folding portion 215 facilitates the first and second lamination portions 210 and 220 to be folded with each other, and as shown in fig. 18, the folding portion 215 is formed with a crease, that is, a crease of the folding portion 215 is formed during the molding of the fitting portion 200, so that the first and second lamination portions 210 and 220 can be conveniently folded with each other along the folding portion 215 during the releasing and pre-loading processes of the conveying device 900.

The folding portion 215 is formed between the first lamination portion 210 and the second lamination portion 220, so that the first lamination portion 210 and the second lamination portion 220 can be folded along the position and the track of the predetermined folding portion 215, the crease formed after the first lamination portion 210 and the second lamination portion 220 are folded can be basically overlapped with the folding portion 215, the positions of the crease are regular, the shape and the size of the folded first lamination portion 210 and the folded second lamination portion 220 are basically consistent with the preset condition, after release is finished, the mutually facing surfaces of the second lamination portion 220 of the first lamination portion 210 are completely attached, and the distal blocking piece is in a completely folded state.

If the attaching portion 200 is not provided with the folding portion 215, the attaching portion 200 is folded under the anatomical structure of the tissue defect 1005 and the influence of the blood flow washout in the first laminating portion 210 and the second laminating portion 220, the crease position between the first laminating portion 210 and the second laminating portion 220 may be not ideal, and incomplete folding may occur between the two, that is, a gap between adjacent side surfaces of the first laminating portion 210 and the second laminating portion 220 is larger, which is easy to cause poor sealing effect and high risk of thrombosis of the apparatus.

As shown in fig. 19, in some embodiments, a bending groove is formed in the folded portion 215. That is, the lamination portion 200 is formed with a groove on the surface of the folding portion 215, that is, the lamination portion 200 in a sheet shape is thinned at the position of the folding portion 215, so that the first lamination portion 210 and the second lamination portion 220 are guided to be folded at the position. The shape of the bending groove is not limited and may be set to be a straight line along a predetermined folding position as shown in fig. 19.

The folding portion 215 is used to divide different laminated portions, and the attaching portion 200 may be a plurality of folding portions having one structural form, and the attaching portion 200 may be a plurality of folding portions having different structural forms.

As shown in fig. 20, in some embodiments, the folding portion 215 may use other structures of bending grooves, such as a plurality of bending grooves provided in a folding portion 215, and three structures of folding portions 215, respectively designated as folding portion 215A, folding portion 215B and folding portion 215C, are shown in fig. 20. The folding portions 215A and 215B and 215C respectively include a plurality of bending grooves arranged in an array. The folding portion 215A is rectangular with the bending grooves in the folding portion 215B, except that the extending direction of the bending grooves in the folding portion 215A is along the extending direction of the folding portion 215A, and since the first lamination portion 210 and the second lamination portion 220 are folded with each other in the axial direction (vertical direction in fig. 20) of the attaching portion 200, the extending direction of the folding portion 215A is perpendicular to the axial direction of the attaching portion 200, that is, the extending direction of each bending groove in the folding portion 215A is perpendicular to the axial direction of the attaching portion 200. The extending direction of each bending groove in the folded portion 215B is not perpendicular to the axial direction of the attaching portion 200, and may be parallel to the axial direction of the attaching portion 200, for example. The plurality of bending grooves in the folded portion 215C are arranged in an array, each bending groove has an elliptical shape, and the long axis direction (extending direction) thereof is perpendicular to the axial direction of the attaching portion 200.

In the embodiment in which the folded portion shown in fig. 20 includes a plurality of bending grooves, the bending grooves may be through holes penetrating in the thickness direction of the folded portion 215, that is, bending holes.

It will be appreciated that in other embodiments, the bending grooves/bending holes may take the form of other cross-sectional shapes, such as circles, waves, etc., which are not described herein, and the number of bending grooves/bending holes and the extending direction may be adjusted as required.

In the present embodiment, the structure of the folded portion 215 is described taking the attaching portion 200 as a rectangle as an example, it is to be understood that in other embodiments, the attaching portion 200 may take other structural forms, which will not be described herein.

In the present embodiment, the folded portion 215 is provided between the first laminated portion 210 and the second laminated portion 220, and for example, there are three cases where a crease, a bending groove, or a bending hole is provided in the folded portion 215, and in the delivery state (where the occlusion device 100F is at least partially positioned in the delivery device 900) and in the natural state (where the occlusion device 101A is not subjected to the force of the delivery device 900 and the living tissue), the attaching portion 200 may exist.

In the first case, the attaching portion 200 is in an unfolded state, that is, the first laminated portion 210 and the second laminated portion 220 are not folded along the folded portion 215. If the lamination portion 200 is formed into the folded portion 215 before the lamination portion 215 is assembled with the fixing member 300 during the molding process, and if the lamination portion 200 is formed into a predetermined shape (a plane or a curved surface) before the formation of the folded portion 215, in the first case, the lamination portion 200 still maintains or substantially maintains the predetermined shape after the formation of the folded portion 215, the first lamination portion 210 and the second lamination portion 220 are not folded along the folded portion 215, and in the embodiment shown in fig. 13, an angle between the first lamination portion 210 and the second lamination portion 220 is 180 °.

In the second case, the lamination portion 200 is in a half-folded state, and the lamination portions are folded over each other along the folded portion 215, but the surfaces of the lamination portions facing each other are not completely abutted (form a significant gap). In the half-folded state shown in fig. 17 and 22, the attaching portion 200 is bent in a W shape. In an embodiment in which the bonding portion 200 includes only the first lamination portion 210 and the second lamination portion 220 and no other lamination portion is provided, the first lamination portion 210 and the second lamination portion 220 may have a V-shape. In embodiments having more than two laminates, the multiple laminates may be folded in a zigzag or wavy pattern. In some embodiments, some of the lamination portions 200 are fully laminated together, and other lamination portions are not fully laminated together.

As shown in fig. 21 and 22, in the conveying state, the bonding portion 200 is positioned inside the conveying device 900 in a semi-folded state, and an angle between the first lamination portion 210 and the second lamination portion 220 is a,0 ° < a <180 °. a=0° is a fully folded state, and a=180° is an unfolded state. To achieve the above-described semi-folded state, the first and second lamination portions 210 and 220 may be folded with each other before the releasing process of the lamination portion 200 (e.g., during the conveying process, the loading process, and the molding process of the lamination portion 200) so as to form the folded portion 215, and to maintain the first and second lamination portions 210 and 220 spaced apart from each other at one end thereof remote from the folded portion 215.

It will be appreciated that in the delivery state, the attachment portion 200 is in a semi-folded state, the attachment portion 200 may be shaped prior to loading the occluding device 100F into the delivery device 900 to provide the attachment portion 200 in a semi-folded state, or the attachment portion 200 may be folded during loading. In some embodiments, the semi-folded state of the conformable portion 200 during transport is formed by folding the conformable portion 200 over one another during both the forming process and the loading into the transport apparatus 900.

It should be noted that, in the delivery state, the extending direction of the folding portion 215 of the attaching portion 200 is along the extending direction of the lumen of the delivery device 900, so that other additional folds are avoided being formed on the folding portion 215, the process flow is simplified, the attaching portion 200 is more smoothly attached to the tissue surface, the thickness of the plugging device after implantation is reduced, and the probability of thrombus formation is reduced.

It will be appreciated that in the second instance, the distal occluding component is gradually folded over as the operator gradually tightens the securing member 300 after it is released from the delivery device 900. In some preferred embodiments, the stack can be fully compressed by pulling on the anchor 300, such that the distal closure is in a fully collapsed state.

In the third case, the bonding portion 200 is in a completely folded state, and the bonding portion 200 is formed into a multi-layered structure by fixing the adjacent stacked portions to each other by solution bonding, medical glue bonding, or by sewing, hot pressing, or fixing with a high polymer anchor, for example, as described in the following embodiments.

Seventh embodiment

Referring to fig. 23, the present embodiment provides an occlusion device 101G, where the occlusion device 101G may be used with the delivery device 900 provided in the first embodiment to obtain a corresponding occlusion system, and the delivery device 900 may be used to deliver and release the occlusion device 100G.

The occlusion device 101G includes a support 100, a conformable segment 200, and a mount 300 connected between the support 100 and the delivery device through the conformable segment 200. The occluding device 101G in the present embodiment is mainly different from the occluding device 100F in the sixth embodiment in that the first laminated portion 210 and the second laminated portion 220 are mutually folded and fixed in a laminated structure by the same sheet.

In this embodiment, the first lamination portion 210 and the second lamination portion 220 have substantially the same shape and size, and the edges of the first lamination portion 210 and the second lamination portion 220 may be aligned and then fixed to each other, and the fixing method may be solution bonding, medical glue bonding, or fixing using stitching, heat pressing, or an anchor made of a polymer material.

The first lamination portion 210 and the second lamination portion 220 that are laminated with each other are formed by mutually folding and fixing the same sheet (the lamination portion 200), that is, when the lamination portion 200 is outside the living body, the first lamination portion 210 and the second lamination portion 220 are mutually fixed and keep a folded state to realize a laminated structure, and the mutual folding is not required to be realized in the living body by pulling the fixing piece 300, so that different stacked states of the lamination portion 200 in the in-vivo folding process can be avoided, and the lamination portion 200 and the blood vessel wall can be more laminated.

In some embodiments, the first lamination portion 210 is non-uniform in shape with the second lamination portion 220, at least a portion of the periphery of the first lamination portion 210 is fixedly connected to the second lamination portion 220, and/or at least a portion of the periphery of the second lamination portion 220 is fixedly connected to the first lamination portion 210, thereby achieving mutual fixation of the two lamination portions. The edges of the two laminates are secured to each other, facilitating the formation of a flat peripheral edge of the distal closure member 401, reducing the risk of instrument thrombosis from the peripheral edge of the distal closure member 401.

In some modified embodiments, for example, in addition to the fourth embodiment, the first lamination portion 210 and the second lamination portion 220 are made of different sheets, and the first lamination portion 210 and the second lamination portion 220 that are laminated with each other may be laminated and fixedly connected to each other in vitro by adopting the above-mentioned fixing manner, that is, the first lamination portion 210 and the second lamination portion 220 are mutually fixed into a laminated structure by different sheets, so as to improve the sealing performance of the bonding portion 200.

Eighth embodiment

Referring to fig. 24, the present embodiment provides an occlusion device 101H, where the occlusion device 101H can be used with the delivery device 900 provided in the first embodiment to obtain a corresponding occlusion system, and the delivery device 900 can deliver and release the occlusion device 100H.

The occlusion device 101H includes a support 100, a conformable segment 200, and a mount 300 connected between the support 100 and the delivery device through the conformable segment 200. The occluding device 101H in the present embodiment is mainly different from the occluding device 100G in the seventh embodiment in that the attaching part 200 and the supporting part 100 are mutually fixed in a laminated structure.

In the foregoing embodiment, the supporting portion 100 and the attaching portion 200 are of a separate structure. In the present embodiment, as shown in fig. 24, the support portion 100 and the attaching portion 200 are fixedly connected to each other or integrally formed. The laminating structure between the laminating portion 200 and the supporting portion 100, and between the laminating portions in the laminating portion 200 can be integrally fixed by adopting solution bonding, medical glue bonding, or by stitching, hot pressing, fixing with high polymer anchors, or other manners, that is, after the plugging device 101H is molded and assembled, the distal plugging member 501 is an integral structure, the laminating structure of the laminating portion 200 is fixed, the laminating form of the supporting portion 100 and the laminating portion 200 is fixed, the situation that the laminating portion 200 is folded by gradually abutting and extruding the supporting portion 100 in a living body is avoided, and different stacking states occur in the in-vivo folding process of the laminating portion 200, so that the plugging success rate is improved.

Ninth embodiment

Referring to fig. 25, the present embodiment provides an occlusion device 101I, where the occlusion device 101I can be used with the delivery device 900 provided in the first embodiment to obtain a corresponding occlusion system, and the delivery device 900 can deliver and release the occlusion device 100I.

The occlusion device 101H includes a support 100, a conformable segment 200, and a mount 300 connected between the support 100 and the delivery device through the conformable segment 200. The occluding device 101I in the present embodiment is mainly different from the occluding device 100B in the second embodiment in that the attaching part 200 and the supporting part 100 are integrally formed, and the attaching part 200 is provided at least at the peripheral edge and the proximal end of the supporting part 100.

As shown in fig. 25, the attaching portion 200 and the supporting portion 100 are integrally formed, or may be integrally formed and then fixedly connected to each other. The supporting portion 100 includes a proximal surface 205, a distal surface 204, and a sidewall 206 connecting between the proximal surface 205 and the distal surface 204, and the attaching portion 200 is connected to the proximal surface 205 and the sidewall 206 of the supporting portion in order to avoid damaging tissue at the edge of the supporting portion 100.

In this embodiment, the attaching portion 200 is integrally combined with the supporting portion 100 to form a distal blocking member, the distal blocking member has a truncated cone shape, and the supporting portion 100 has a truncated cone shape. In other embodiments, the support portion 100 may have a cylindrical shape, a drum shape, or the like, and the bonding portion 200 may have a rectangular parallelepiped shape, a tapered shape, an inverted tapered shape, or the like.

Tenth embodiment

Referring to fig. 26 to 28, the present embodiment provides an occlusion device 101J, where the occlusion device 101J can be used with the delivery device 900 provided in the first embodiment to obtain a corresponding occlusion system, and the delivery device 900 can deliver and release the occlusion device 100J.

The occlusion device 101J includes a support 100, a conformable segment 200, and a mount 300 connected between the support 100 and the delivery device 900 through the conformable segment 200. The primary difference between the occluding device 101J in this embodiment and the occluding device 100G in the seventh embodiment is that the occluding device 101J further comprises a proximal occluding component 400 disposed proximal to the distal occluding component, the proximal occluding component 400 being configured to occlude a proximal gap 1007 of a tissue defect 1005, the proximal occluding component 400 being coupled to a securing component 300, the securing component 300 being configured to be secured to tissue proximal to the proximal occluding component 400.

Specifically, the proximal blocking member 400 is provided with a penetrating hole through which the fixing member 300 passes, the fixing member 300 is penetrated into the penetrating hole of the proximal blocking member 400, and the technical solution of the penetrating hole in the distal blocking member can be applied to the proximal blocking member 400 without contradiction.

As shown in fig. 26, in the distal blocking member, the attaching portion 200 and the supporting portion 100 are in a separate structure, and it is understood that in other embodiments, the attaching portion 200 and the supporting portion 100 may be fixed together or integrally formed.

In the conveying state, in the conveying device 900, the bonding portion 200 and the supporting portion 100 at least partially overlap in the axial direction of the conveying device 900.

The delivery device 900 includes an outer sheath 910, an inner sheath core 930, and an intermediate sheath 950 disposed between the outer sheath 910 and the inner sheath core 930, and the outer sheath 910, the intermediate sheath 950, and the inner sheath core 930 are sequentially stacked from outside to inside in the radial direction of the delivery device 900.

In the delivery state, the distal end of the outer sheath 910, the distal end of the intermediate sheath 950 and the distal end of the inner sheath core 930 are sequentially arranged from far to near, the proximal blocking member 400 is accommodated in the inner cavity of the intermediate sheath 950, the distal end of the outer sheath 910 accommodates the distal blocking member, the distal end of the intermediate sheath 950 accommodates the proximal blocking member 400, and the distal end of the inner sheath core 930 is located proximal to the proximal blocking member 400. In the delivery state, in the delivery device 900, the distal occluding component is disposed between the distal end of the outer sheath 910 and the distal end of the intermediate sheath 950, and the proximal occluding component 400 is disposed between the distal end of the intermediate sheath 950 and the distal end of the inner sheath core 930.

During release, the inner sheath core 930 and the intermediate sheath 950 can be controlled by the delivery device 900 to be immobilized and the outer sheath 910 can be controlled to move proximally (retract) to release the distal closure member, and the inner sheath core 930 and the intermediate sheath 950 can be controlled to move in opposite directions by the delivery device 900 to release the proximal closure member 400, such as by moving distally (pushing) the inner sheath core 930, immobilizing the intermediate sheath 950 to immobilize the proximal closure member 400, or holding the inner sheath core 930 immobilized, moving proximally (retracting) the intermediate sheath 950 to release the proximal closure member 400, or by moving proximally (retracting) the intermediate sheath 950 while moving distally (pushing) the inner sheath core 930 to release the proximal closure member 400.

In the delivery state, the distal blocking member (the supporting portion 100 and the attaching portion 200) and the proximal blocking member 400 are disposed at intervals in the axial direction of the delivery device 900, so that the fixing member 300 between the distal blocking member and the proximal blocking member 400 is ensured to be long enough, so that after releasing the distal blocking member on the distal side of the tissue defect 1005 and completing the blocking of the distal notch 1006, an operator can release the proximal blocking member 400 as required to block the proximal notch 1007.

In particular, the delivery device 900 is provided with the middle sheath 950, and in the delivery state, the proximal blocking member 400 is accommodated in the middle sheath 950, so that the distal blocking member and the proximal blocking member 400 can be precisely controlled to release step by controlling the operations of the outer sheath 910, the middle sheath 950 and the inner sheath 930, the delivery device 900 does not need to perform development treatment, DSA perspective is not needed in the release process, and blind operation is realized.

As shown in fig. 27, the anchor 300 is formed with a knot 302 at the distal end of the inner sheath core 930, the knot 302 being disposed proximal to the proximal occlusion 400. Specifically, the inner sheath core 930 has a plurality of channels disposed therethrough at a proximal end and a distal end, the delivery device 900 includes a push rod 970 for threading into the inner sheath core 930, the distal end of the push rod 970 extending from the distal end of the inner sheath core 930, the portion of the push rod 970 extending distally from the inner sheath core 930 for carrying and winding the knot 302, the knot 302 disposed about a sidewall of the distal end of the push rod 970.

The fixing member 300 is in a wire shape having two free ends, and the two free ends of the fixing member 300 can be knotted to form a knot 302, and the knot 302 is sleeved on the distal end of the push rod 970, and the two ends of the fixing member 300 are connected to a handle in the delivery device.

In this embodiment, the knot 302 is a sliding knot, and by moving (pulling or loosening) one free end of the fixing element 300 proximally or distally through the delivery device 900, the length of the fixing element 300 distal to the knot 302 can be reduced or increased, i.e. the distance between the distal blocking element and the proximal blocking element 400 can be adjusted until the distal blocking element and the proximal blocking element 400 can clamp the tissue defect 1005 from both sides, thereby achieving a hemostatic effect.

The knot 302 is removed from the distal end of the pusher rod 970 by controlling the pusher rod 970 to move proximally (retract) into the interior of the inner sheath core 930 by the delivery device 900.

The other end of the anchor 300 is proximally (pulled) by the delivery device 900 to effect a lock knot, i.e., a locking knot 302, to secure the distance between the proximal block piece 400 and the distal block piece.

The anchor 300 is used to secure tissue proximal to the distal closure, as shown in fig. 3.

Further, the securing member 300 is configured to be secured to tissue proximal of the proximal block 400, and in particular, the delivery device 900 is configured to lock the knot 302 proximal of the proximal block 400, i.e., to secure to tissue proximal of the proximal block 400, such as a blood vessel 1002 or a biological body surface 1001, or tissue between the blood vessel 1002 and the biological body surface 1001, with the knot 302, or to secure to tissue proximal of the proximal block 400, other than with the knot 302, such as suturing, or with other locking means. After the locking is completed, the fastener 300 may be sheared by the thread cutting device at the end of the knot 302 or the biological body surface 1001 to complete the release process.

In this embodiment, the delivery device 900 is used to control both free ends of the mount 300, as well as the ends of the push rod 970. In alternative embodiments, the two free ends of the anchor 300 are not secured to the delivery device 900, the anchor 300 may not be pulled by the delivery device 900, the anchor 300 may be pulled by an operator (e.g., a physician) or other device, the end of the push rod 970 may not be secured to the delivery device, may be controlled manually by the operator directly, or by other devices.

In this embodiment, the proximal blocking member 400 is planar and sheet-like, and in some variations, the proximal blocking member 400 may be configured in an arch-like fashion similar to the buttress portion 100 to facilitate conforming to the tissue defect morphology, and the proximal blocking member 400 may be configured as desired to accommodate blocking different tissue defects.

In some embodiments, the proximal block 400 is made of a flexible material, so that the proximal block 400 can better fit the peripheral tissue of the defect, improve the blocking performance, and reduce the damage and irritation to the tissue. Preferably, proximal block piece 400 is more flexible than support 100.

In some variations, the multiple components in the distal closure are fixed in one piece, or integrally formed, preferably in a stacked configuration. Preferably, between laminating portion 200 and supporting part 100, and between a plurality of laminating portions in laminating portion 200, can be fixed in an organic whole through adopting solution bonding, medical glue bonding, or utilizing modes such as sewing up, hot pressing, and fixing with the anchor of polymer material, promptly after plugging device shaping and equipment are accomplished, be integrated into one piece structure, preferably fix to laminated structure, make laminating structure of laminating portion 200 fixed, supporting part 100 is fixed with laminating portion 200's laminating form, avoid in the organism, supporting part 100 is by and extrusion laminating portion 200 folds gradually, can avoid distal side shutoff piece to appear different stacked state at the folding in-process in vivo, can make distal side shutoff piece and vascular wall laminate more, improve the shutoff success rate.

In some embodiments, the abutment 200 in the distal closure is integrally fixed to the support 100, and the plurality of laminations in the abutment 200 are not fixed to form a lamination.

Eleventh embodiment

Referring to fig. 29 to 30, the present embodiment provides an occlusion device 101K, where the occlusion device 101K can be used with the delivery device 900 provided in the first embodiment to obtain a corresponding occlusion system, and the delivery device 900 can deliver and release the occlusion device 100K.

The occluding device 101K includes a support 100, a conformable segment 200, a proximal occluding component 400, and a securing component 300 coupled between the support 100 and the delivery device through the conformable segment 200 and the proximal occluding component 400. The main difference between the occlusion device 101K of the present embodiment and the occlusion device 100J of the tenth embodiment is that the proximal occlusion member 400 of the occlusion device 100K includes a support portion 450 and a fitting portion 410.

The structure of the supporting portion 450 in the proximal blocking member 400 is identical to that of the proximal blocking member 400 in the tenth embodiment, please refer to the tenth embodiment, and a detailed description thereof will be omitted.

The configuration of the abutment 410 can be referred to as the configuration of the abutment 200 in the distal closure in any of the other embodiments. In the conveying state, any one of the unfolded state, the half-folded state and the fully folded state can be maintained, and a description thereof will not be given here.

In the present embodiment, referring to the bonding portion 200 in fig. 26, the bonding portion 410 includes a plurality of lamination portions, and in a natural state, the bonding portion 410 is kept in a fully folded state.

In this embodiment, the proximal blocking member 400 and the distal blocking member are both provided with a bonding portion, and the bonding portion is made of a soft material, so that a multi-layer flexible multi-layer blocking structure can be formed on both sides of the tissue defect, and the blocking effect is good.

In a modified embodiment, the support portion 100 and the attaching portion 200 in the distal seal are fixed together, and the plurality of laminated portions in the attaching portion 200 are fixed together in a laminated structure, that is, the distal seal is fixed and molded in a laminated structure. Similarly, the support portion 450 and the attaching portion 410 of the proximal blocking member 400 may be fixed together, and the multiple stacking portions of the attaching portion 410 are fixed together to form a stacked structure, that is, the proximal blocking member 400 is fixed and formed to form a stacked structure, so that the distal blocking member is prevented from being folded to obtain different stacked states during the release process, and the proximal blocking member 400 is prevented from being folded to obtain different stacked states during the release process, so that the blocking device 101K can be attached to the wall of a blood vessel more.

The specific technical solutions in the above embodiments may be mutually applicable.

While the invention has been described with reference to several exemplary embodiments, it is to be understood that the terminology used is intended to be in the nature of words of description and of limitation. As the present invention may be embodied in several forms without departing from the spirit or essential characteristics thereof, it should also be understood that the above-described embodiments are not limited by any of the details of the foregoing description, but rather should be construed broadly within its spirit and scope as defined in the appended claims, and therefore all changes and modifications that fall within the meets and bounds of the claims, or equivalences of such meets and bounds are therefore intended to be embraced by the appended claims.

Claims

1. The utility model provides a plugging device, its characterized in that, plugging device is used for shutoff tissue defect, plugging device includes distal side shutoff piece, distal side shutoff piece is used for shutoff in the defective distal side breach of tissue, distal side shutoff piece includes supporting part and laminating portion, laminating portion is used for laminating in the tissue, supporting part is used for supporting laminating portion, the hardness of supporting part is greater than laminating portion.

2. The occlusion device of claim 1, wherein said support portion and said conformable portion are of a split construction, said support portion being disposed distally of said conformable portion.

3. The occlusion device of claim 1, wherein said support portion is integrally formed with said conformable portion, said conformable portion being disposed at least about a periphery and proximal end of said support portion.

4. The occlusion device of claim 3, wherein the support portion comprises a proximal face, a distal face, and a side face connecting between the proximal face and the distal face, and wherein the conforming portion is connected to the proximal face and the side face of the support portion.

5. The occlusion device of any of claims 1-4, wherein the support portion is arched.

6. The occlusion device of any of claims 1-4, wherein the device comprises a flexible member,

The supporting part is made of at least one of non-degradable material, degradable biological material and degradable polymer material, and/or

The attaching part is made of at least one of non-degradable materials, degradable biological materials and degradable high polymer materials.

7. The occlusion device of any of claims 1-4, wherein said conformable portion swells with water.

8. The occlusion device of any of claims 1-4, wherein the conformable portion comprises a first laminate portion and a second laminate portion, the support portion, the first laminate portion, and the second laminate portion being disposed in a laminate in a distal direction of the tissue defect to occlude a distal breach of the tissue defect.

9. The occlusion device of claim 8, wherein said first layered portion is disposed distally of said second layered portion, said second layered portion being formed with a through hole, said occlusion device comprising a securing member attached to said distal occlusion member, said securing member being disposed through said through hole, one end of said securing member being attached to said first layered portion and the other end of said securing member being attached to the delivery device;

During release of the occlusion device, the proximal side of the second laminate is restrained to the peripheral tissue of the distal notch, and the securing member pulls the support proximally such that the support, the first laminate and the second laminate are laminated to each other in a distal direction of the tissue defect.

10. The occlusion device of claim 9, wherein said first laminate section and said second laminate section are folded from the same sheet.

11. The occlusion device of claim 10, wherein said first laminate section and said second laminate section fold over one another during proximal pulling of said support section by said anchor.

12. The occlusion device of claim 11, wherein a fold is formed between the first laminate portion and the second laminate portion, the fold facilitating folding of the first laminate portion and the second laminate portion in a distal direction of the tissue defect;

The support portion pushes the first and second lamination portions to fold over each other along the fold portion during proximal pulling of the support portion by the fastener.

13. The occlusion device of claim 12, wherein at least one of a crease, a bending groove, and a bending aperture is formed in the fold.

14. The occlusion device of claim 8, wherein said first laminate portion and said second laminate portion are secured to one another in a laminate configuration by being folded from the same sheet.

15. The occlusion device of claim 14, wherein said conformable portion and said support portion are secured to one another in a stacked configuration.

16. The occlusion device of claim 2, wherein said first laminate section and said second laminate section are secured to each other in a laminate structure by different sheets.

17. The occlusion device of any of claims 1-4, 8 or 16, wherein,

The fixation member being for fixation to tissue proximal to the distal closure member, or

The occlusion device further comprises a proximal occlusion member disposed proximal to the distal occlusion member, the proximal occlusion member configured to occlude a proximal gap of the tissue defect, the proximal occlusion member coupled to the securing member configured to secure to tissue proximal to the proximal occlusion member, or

The blocking device further comprises a proximal blocking member arranged on the proximal side of the distal blocking member, the proximal blocking member is used for blocking a proximal gap of the tissue defect, the proximal blocking member is connected with the fixing member, the fixing member comprises a knot arranged on the proximal side of the proximal blocking member, and the knot is used for locking the proximal side of the proximal blocking member so as to fix the distance between the proximal blocking member and the distal blocking member.

18. An occlusion system comprising a delivery device for delivering and releasing said occlusion device to said tissue defect, and an occlusion device according to any of claims 1-17.

19. The occlusion system of claim 9, comprising a delivery device and the occlusion device of claim 9, wherein upon release of the occlusion device, the delivery device is configured to pull the support portion proximally through the anchor such that the support portion, the first laminate portion, and the second laminate portion are laminated to one another in a distal direction of the tissue defect after the distal occlusion member is released from the distal end of the delivery device to the distal side of the tissue defect.

20. A closure system comprising a delivery device and the closure device of any one of claims 1-16, the closure device further comprising a proximal closure member disposed proximal to the distal closure member, the proximal closure member configured to close a proximal gap of the tissue defect, the proximal closure member coupled to the securing member, the securing member comprising a knot disposed proximal to the proximal closure member, the delivery device configured to lock the knot proximal to the proximal closure member to secure a distance between the proximal closure member and the distal closure member.