Occluder and occlusion system

Abstract

The present invention relates to an occluder and occlusion system, wherein the occluder comprises a first occluding disc; a second occluding disc located distal to the first occluding disc; and a connecting assembly disposed between and connected to the first and second occluding discs, respectively. The connecting assembly comprises a connector, which is a ribbon-shaped elastic member capable of compressed and expanded states. In the expanded state, the connector includes at least one bent structure that abuts against the inner wall of a porous channel. The present invention aims to provide an occluder capable of rapid endothelialization.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices and equipment, and in particular to an occluder and an occlusion system. Background Art

[0002] Congenital heart diseases such as atrial septal defect (ASD), ventricular septal defect (VSD), patent ductus arteriosus (PDA), and patent foramen ovale (PFO) all share the common characteristic of forming a hole-like passageway. For example, the foramen ovale forms during the sixth or seventh week of embryonic development when two septa are formed in the atrial septum. The first septum to appear is the primum septum, or primary septum, and the second septum is the secundum septum, or secondary septum. The primum septum grows in a semilunar shape from the dorsal wall of the atrial midline, grows toward the atrioventricular canal, and fuses with the endocardial cushions, leaving a small opening at the caudal end of the atrioventricular septum, called the ostium primum. Before the ostium primum closes, a hole forms near the cranial end of the septum primum, called the ostium secundum, which serves as a normal blood passage during fetal development. At the same time, a sickle-shaped septum grows from the atrial wall on the right side of the first septum, called the secondary septum or the second septum. This septum does not continue to grow and stops separating the atria halfway. The sickle-shaped depression is oval and is called the fossa oval. At the fossa oval, the primary septum and the secondary septum fail to adhere and fuse, leaving a gap called the foramen ovale.

[0003] With the continuous development of interventional materials, devices, and interventional cardiology, minimally invasive transcatheter occlusion of these pore-like defects is currently the primary treatment. The occluder consists of a left disc, a right disc, and a waist connector connecting the two discs. The defect created by a patent foramen ovale is a long, narrow, pore-like channel, and the length and width of this channel vary significantly from patient to patient. Consequently, existing occluders often suffer from poor adhesion and limited surface area between the waist connector and the foramen ovale, hindering endothelialization. Summary of the Invention

[0004] In view of the above problems, the present invention aims to provide an occluder that can rapidly endothelialize.

[0005] This purpose is achieved through the following technical solutions:

[0006] According to the technical solution of the first aspect of the present invention, an occluder is proposed, which includes: a first occluding disk; a second occluding disk, located on one side of the distal end of the first occluding disk; a connecting component, arranged between the first occluding disk and the second occluding disk and connected to the first occluding disk and the second occluding disk respectively, the connecting component includes a connecting member, the connecting member is an elastic member in a strip shape and has a compressed state and an expanded state, in the expanded state, the connecting member includes at least one bending structure, and the bending structure is against the inner wall of the porous channel.

[0007] In some embodiments of the present invention, the radial dimension of the connector in the expanded state is greater than the radial dimension of the connector in the compressed state, and / or the axial dimension of the connector in the expanded state is smaller than the axial dimension of the connector in the compressed state.

[0008] In some embodiments of the present invention, the connecting component further includes a first flexible wire and / or a second flexible wire, the proximal end of the connecting member is connected to the first occluding disk via the first flexible wire, and the distal end of the connecting member is connected to the second occluding disk via the second flexible wire.

[0009] In some embodiments of the present invention, the occluder further comprises:

[0010] A first universal mechanism, the first universal mechanism includes a first buckle provided at the distal end of the first sealing disk and a first ball rotatably provided on the first buckle, the first ball being connected to the connecting component; and / or a second universal mechanism, the second universal mechanism includes a second buckle provided at the proximal end of the second sealing disk and a second ball rotatably provided on the second buckle, the second ball being connected to the connecting component.

[0011] In some embodiments of the present invention, the proximal end of the connector is provided with a first bundling structure, and the radial size of the first bundling structure gradually decreases from the distal end to the proximal end; and / or the distal end of the connector is provided with a second bundling structure, and the radial size of the second bundling structure gradually decreases from the proximal end to the distal end.

[0012] In some embodiments of the present invention, the connecting assembly further comprises: a first loop, which is movably disposed at the proximal end of the connecting member; and / or a second loop, which is movably disposed at the distal end of the connecting member.

[0013] In some embodiments of the present invention, the connecting member is in a mesh shape, and the porosity of the connecting member ranges from 10% to 30%.

[0014] In some embodiments of the present invention, in the expanded state, along the axial direction, the connector includes a plurality of bending structures connected in sequence, so that the connector as a whole has an arc-shaped structure, or a spiral structure, or a wavy structure, or a broken line structure.

[0015] In some embodiments of the present invention, when the connecting member has a wavy structure, the connecting member includes at least one wave period, each wave period includes a crest and a trough, and along the axial direction, the length of each wave period ranges from 1 mm to 2 mm.

[0016] According to a second technical solution of the present invention, a occlusion system is provided, comprising a conveyor and the occluder of the first technical solution, wherein the occluder can be conveyed to a target position via the conveyor.

[0017] The occluder of the present invention, on the one hand, has the connector as an elastic member. After the connector is released, the connector forms at least one bent structure by self-expansion to fit the inner wall of the porous channel, so that the connector can adapt to porous channels of different widths and sizes, improve the wall adhesion effect of the connector and the porous channel, and enable the connector in the porous channel to achieve endothelialization. On the other hand, the connector is configured in a strip shape to increase the contact area between the connector and the inner wall of the porous channel, thereby improving the endothelial climbing efficiency on the connector per unit time. It should also be noted that by forming a bent structure in the connector, the surface area of the connector in the porous channel per unit length is increased, thereby increasing the endothelial climbing area in the porous channel to enhance the blocking effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Various other advantages and benefits will become apparent to those skilled in the art upon reading the detailed description of the preferred embodiment below. The accompanying drawings are for illustration purposes only and are not to be considered as limiting the present invention. The same reference numerals are used throughout the accompanying drawings to denote the same components. In the accompanying drawings:

[0019] Figure 1 Schematically shows a schematic diagram of an occluder blocking a hole-shaped channel according to an embodiment of the present invention;

[0020] Figure 2 Schematically shows a structural diagram of an occluder from a left perspective according to an embodiment of the present invention;

[0021] Figure 3 Schematically shows a structural diagram of an occluder from a main viewing angle according to an embodiment of the present invention;

[0022] Figure 4 Schematically shows a schematic structural diagram of an occluder according to an embodiment of the present invention from a top view;

[0023] Figure 5 Schematically shows a structural diagram of an occluder according to an embodiment of the present invention from a bottom-up perspective;

[0024] Figure 6 Schematically shows a structural diagram of a connector according to an embodiment of the present invention from a main viewing angle;

[0025] Figure 7 Schematically shows a structural diagram of a connector according to an embodiment of the present invention from a main viewing angle;

[0026] Figure 8 Schematically shows a cross-sectional structural diagram of a second universal joint according to an embodiment of the present invention;

[0027] Figure 9 Schematically shows a cross-sectional structural diagram of a first occluding disk according to an embodiment of the present invention;

[0028] Figure 10 The figure schematically shows a schematic diagram of an occluder blocking a hole-shaped channel according to an embodiment of the present invention.

[0029] The reference numerals are as follows:

[0030] 100-occluder;

[0031] 10-first sealing disk, 11-first bolt head, 12-first sealing head, 121-threaded hole;

[0032] 20-second sealing disk, 21-second plug head, 22-second sealing head;

[0033] 30-connecting assembly, 31-connecting member, 311-bending structure, 312-first bundling structure, 313-second bundling structure, 314-main body, 32-first flexible wire, 33-second flexible wire, 34-first universal mechanism, 341-first buckle, 342-first ball, 35-second universal mechanism, 351-second buckle, 352-second ball, 36-first rope loop, 37-second rope loop;

[0034] 200-porous channel;

[0035] 201-primary septum, 202-secondary septum. DETAILED DESCRIPTION

[0036] Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments described herein. Rather, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0037] It should be understood that the terms used herein are for the purpose of describing specific example embodiments only and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used herein may also be meant to include plural forms. The terms "comprise", "include", "contain" and "have" are inclusive and therefore specify the presence of stated features, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring them to be performed in the specific order described or illustrated, unless the order of execution is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0038] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates otherwise, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0039] For ease of description, spatially relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figures, such as "inside," "outside," "inside," "outside," "below," "beneath," "above," and the like. Such spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is flipped, an element described as "below" or "below" another element or feature would then be oriented as "above" or "above" another element or feature. Thus, the example term "below" can include both above and below orientations. The device may be otherwise oriented (rotated 90 degrees or in other orientations) and the spatially relative descriptors used herein are interpreted accordingly.

[0040] It should be noted that the terms "distal" and "proximal" are commonly used in the field of interventional medical devices. "Distal" refers to the end away from the operator during surgery, while "proximal" refers to the end closer to the operator. Axial refers to the direction parallel to the line connecting the distal and proximal centers of the medical device; radial refers to the direction perpendicular to the axial direction.

[0041] Please combine Figure 1 As shown, according to an embodiment of the present invention, an occluder 100 is proposed.

[0042] The occluder 100 includes a first occluding disk 10, a second occluding disk 20 and a connecting assembly 30. The connecting assembly 30 is located between the first occluding disk 10 and the second occluding disk 20, and the connecting assembly 30 is connected to the first occluding disk 10 and the second occluding disk 20 respectively.

[0043] In detail, the first occluding disc 10 and the second occluding disc 20 are both mesh disc structures with shape memory woven from nickel-titanium wire. During the interventional surgery, the occluding device 100 is retracted in a sheath of corresponding specifications and, under the guidance of X-rays, is delivered to the right atrium through the femoral artery and the inferior vena cava, and then passes through the atrial septal defect to enter the left atrium. Then, the second occluding disc 20 and the first occluding disc 10 are released in the left and right atria respectively, and the connecting component 30 of the occluding device 100 is arranged in the hole-shaped channel 200 (i.e., the foramen ovale), and the second occluding disc 20 is located at the distal end of the hole-shaped channel 200 in the left atrium, and the first occluding disc 10 is located at the proximal end of the hole-shaped channel 200 in the right atrium, thereby blocking blood shunt and achieving the purpose of treatment. Among them, the first occluding disc 10 and the second occluding disc 20 can be disc-shaped, umbrella-shaped, polygonal, etc., as long as the shape can achieve the blocking function.

[0044] Please combine Figure 1and Figure 2 As shown, the connection assembly 30 includes a connector 31, which is an elastically deformable elastic member. The connector 31 has a compressed state and an expanded state. In the compressed state, the connector 31 is constricted to the sheath of the corresponding specification. After the second occluding disk 20 is released, the sheath is further withdrawn to release the connector 31 from the sheath into the porous channel 200. After the connector 31 is released, the connector 31 expands and deforms to form at least one bending structure 311 and adheres to the inner wall of the porous channel 200. The self-expansion of the connector 31 enables the connector 31 to adapt to porous channels 200 of different widths, improves the adhesion effect between the connector 31 and the porous channel 200, and enables the connector 31 in the porous channel 200 to achieve endothelialization.

[0045] In this embodiment, please combine Figure 2 and Figure 3 As shown, the connector 31 is configured in a strip shape, which increases the contact area between the connector 31 and the inner wall of the porous channel 200, thereby improving the endothelial creep efficiency of the connector 31 per unit time. It should also be noted that the formation of the bend structure 311 in the connector 31 increases the surface area of the connector 31 in the porous channel 200 per unit length, thereby increasing the endothelial creep area in the porous channel 200 and enhancing the blocking effect. The strip shape can be understood as the connector 31 having a certain width in the radial direction, so that each bend structure of the connector 31 is in line contact or surface contact with the porous channel 200.

[0046] In some embodiments, in the compressed state, the connector 31 is in the shape of a straight strip. When the connector 31 is released, at least a portion of the connector 31 is bent in at least one direction to form a bent structure 311. The bending direction of the connector 31 has an angle with the plane of the connector 31 in the straight state, and the angle is not zero, so as to ensure that at least a portion of the strip wall of the connector 31 is in contact with the inner wall of the porous channel 200, thereby increasing the contact area between the connector 31 and the inner wall of the porous channel 200.

[0047] In other embodiments, in the compressed state, the connector 31 is in a curved strip-like shape. When the connector 31 is released, at least a portion of the connector 31 continues to bend to form a bent structure 311. In this embodiment, the bent structure 311 is formed by bending at least a portion of the straight strip-like connector 31 in at least one direction. The bending direction of the connector 31 forms an angle with the plane of the connector 31 in the straight state, and the angle is non-zero.

[0048] Among them, the connecting part 31 is made of nickel-titanium alloy with shape memory, so that after the connecting part 31 is released, it can spontaneously expand and deform, so that the connecting part 31 can fit the inner wall of the porous channel 200. In addition, based on the elastic characteristics of the connecting part 31, the connecting part 31 has a certain deformation margin, so that the connecting part 31 can adapt to the porous channels 200 of different widths and improve the wall adhesion effect of the connecting part 31.

[0049] In this embodiment, if Figure 3 As shown, the connector 31 is a shape memory mesh made of nickel titanium wire, and the porosity of the connector 31 ranges from 10% to 30%, such as 10%, 14%, 18%, 20%, 25%, 30%, etc. The porous mesh structure can quickly endothelialize in the pores of the connector 31, so as to quickly realize the porous channel 200 (see Figure 1 ) is closed. The porosity refers to the ratio of the area of all holes per unit area of the connector 31.

[0050] In some embodiments, please combine Figure 1 and Figure 2 As shown, the connection assembly 30 also includes a first flexible wire 32 and a second flexible wire 33 . The proximal end of the connector 31 is connected to the first occluding disk 10 via the first flexible wire 32 , and the distal end of the connector 31 is connected to the second occluding disk 20 via the second flexible wire 33 . The first flexible wire 32 and the second flexible wire 33 are both nickel-titanium wires with a wire diameter of 0.07 mm to 0.22 mm, so that the first flexible wire 32 and the second flexible wire 33 have strong flexibility. Through the multi-angle bending of the first flexible wire 32 and the second flexible wire 33, the first occluding disk 10, the second occluding disk 20 and the connecting component 30 have a high degree of freedom, so that the angle between the first occluding disk 10 and the second occluding disk 20 can be adjusted, so that when the porous channel 200 such as the foramen ovale has multi-angle inclination, the umbrella surface of the first occluding disk 10 and the umbrella surface of the second occluding disk 20 can be better attached to the primary septum 201 and the secondary septum 202, thereby improving the sealing effect of the first occluding disk 10 and the second occluding disk 20 and preventing residual shunt. At the same time, due to the presence of the first flexible wire 32 and the second flexible wire 33, in order to adapt to complex physiological environments, either the first occluding disc 10 or the second occluding disc 20 can adaptively adjust its position and angle without affecting the other, thereby ensuring the relative independence of the first occluding disc 10 and the second occluding disc 20, and being able to more flexibly adapt to complex physiological environments and better achieve occlusion. The wire diameters of the first flexible wire 32 and the second flexible wire 33 can be the same or different.

[0051] In this embodiment, the radial dimension of the connector 31 in the expanded state is greater than the radial dimension of the connector 31 in the compressed state, so that the connector 31 can be tightly attached to the inner wall of the porous channel 200. And / or the axial dimension of the connector 31 in the expanded state is smaller than the axial dimension of the connector 31 in the compressed state. After the connector 31 is completely released, the axial length of the connector 31 is shortened to reduce the total axial length of the connection assembly 30 (in this embodiment, the total length is the distance between the proximal end of the first flexible wire 32 and the distal end of the second flexible wire 33). The elastic force of the connector 31 is used to tighten the first and second sealing disks 10 and 20 through the first and second flexible wires 32 and 33, respectively, providing a pre-tightening force for the first and second sealing disks 10 and 20 to block the porous channel 200, so that the first and second sealing disks 10 and 20 are more firmly attached to the ends of the porous channel 200, preventing residual shunt. In other embodiments, the radial dimension of the connector 31 in the expanded state may be the same as the radial dimension of the connector 31 in the compressed state, or / and the axial dimension of the connector 31 in the expanded state may be the same as the axial dimension of the connector 31 in the compressed state.

[0052] In other embodiments, the connection component 30 includes any one of the first flexible wire 32 or the second flexible wire 33. Alternatively, the connection component 30 does not include the first flexible wire 32 and the second flexible wire 33.

[0053] In some embodiments, please combine Figure 3 、 Figure 8 and Figure 9 As shown, to further improve the degree of freedom between the first occluding disk 10, the second occluding disk 20 and the connecting assembly 30, the occluder 100 further includes a first universal mechanism 34 and a second universal mechanism 35. The first universal mechanism 34 includes a first buckle 341 provided at the distal end of the first occluding disk 10 and a first ball 342 rotatably provided on the first buckle 341. The first ball 342 has multiple degrees of rotational freedom relative to the first buckle 341. The proximal end of the first flexible wire 32 is connected to the first ball 342. The second universal mechanism 35 includes a second buckle 351 provided at the proximal end of the second occluding disk 20 and a second ball 352 rotatably provided on the second buckle 351. The second ball 352 has multiple degrees of rotational freedom relative to the second buckle 351. The distal end of the second flexible wire 33 is connected to the second ball 352. In this embodiment, by providing a first universal mechanism, during the implantation of the occluder 100 into the heart, when the first occluding disk 10 rotates around its own axis x (see Figure 10) rotates, the first buckle 341 and the first ball 342 rotate relative to each other, so that the first ball 342, together with the first flexible wire 32, the connector 31, and the second flexible wire 33, do not move with the first buckle 341. This prevents the rotational force from being transmitted to the first flexible wire 32 and the connector 31, causing the first flexible wire 32 or the connector 31 to twist and deform, thereby affecting the wall adhesion of the connector 31. It is understandable that the function of the second universal mechanism 35 is the same as that of the first universal mechanism 34, and will not be repeated here. In other embodiments, the occluder 100 includes either the first universal mechanism 34 or the second universal mechanism 35, or the occluder 100 does not include the first universal mechanism 34 or the second universal mechanism 35.

[0054] In some embodiments, as Figure 3 As shown, to further increase the degree of freedom between the first and second sealing disks 10, 20, and the connecting assembly 30, the connecting assembly 30 further includes a first loop 36 and a second loop 37, both of which are annular. The first loop 36 is inserted through the proximal end of the connecting member 31 and is rotatable relative to the connecting member 31. The proximal end of the first flexible wire 32 is welded to the first ball 342 (see Figure 9). The distal end of the first flexible wire 32 is connected to the first loop 36, ensuring that the connecting member 31 and the first flexible wire 32 are firmly connected while maintaining a large degree of freedom at the connection. The second loop 37 is inserted through the distal end of the connecting member 31 and is rotatable relative to the connecting member 31. The distal end of the second flexible wire 33 is welded to the second ball 352 (see Figure 8). The proximal end of the second flexible wire 33 is connected to the second loop 37, ensuring that the connecting member 31 and the second flexible wire 33 are firmly connected while maintaining a large degree of freedom at the connection.

[0055] Among them, the first rope loop 36 and the second rope loop 37 are annular parts woven from nickel-titanium wire, or the first rope loop 36 is an annular structure formed by bending the distal end of the first flexible wire 32 360 degrees, and the second rope loop 37 is an annular structure formed by bending the proximal end of the second flexible wire 33 360 degrees.

[0056] In other embodiments, the connection assembly 30 includes any one of the first rope loop 36 and the second rope loop 37 , or the connection assembly 30 does not include the first rope loop 36 and the second rope loop 37 .

[0057] In other embodiments, when the occluder 100 does not include the first flexible wire 32 and the second flexible wire 33, the first rope loop 36 and the second rope loop 37 are directly connected to the first universal mechanism 34 and the second universal mechanism 35, respectively. When the occluder 100 further does not include the first universal mechanism 34 and the second universal mechanism 35, the first rope loop 36 and the second rope loop 37 are directly connected to the first occluding disk 10 and the second occluding disk 20, respectively. It is understandable that the occluder 100 may include at least one of the first flexible wire 32, the second flexible wire 33, the first rope loop 36, the second rope loop 37, the first universal mechanism 34 and the second universal mechanism 35, or the occluder 100 may not include any of them and only include the connector 31. The connection method of the above components can be adjusted accordingly according to the situation.

[0058] In this embodiment, if Figure 3 As shown, the proximal end of the connector 31 is provided with a first bundling structure 312, and the radial dimension of the first bundling structure 312 gradually decreases from the distal end to the proximal end, and the proximal end of the first bundling structure 312 is connected to the first flexible wire 32. The distal end of the connector 31 is provided with a second bundling structure 313, and the radial dimension of the second bundling structure 313 gradually decreases from the proximal end to the distal end, and the distal end of the second bundling structure 313 is connected to the second flexible wire 33. The gradual change in the radial dimensions of the proximal and distal ends of the connector 31 allows the forces between the ends of the connector 31 and the first flexible wire 32 or the second flexible wire 33 to be concentrated at one point, thereby improving the flexibility of the relative movement between the first flexible wire 32 or the second flexible wire 33 and the connector 31, so as to reduce the resistance of the connector 31 when bending relative to the first flexible wire 32 or the second flexible wire 33, and also facilitate entry into the sheath.

[0059] In some embodiments, in the expanded state, the first bunching structure 312 and the second bunching structure 313 can be conical in shape, and the top of the cone shape is the proximal and distal ends of the connector 31. The gradual change in the radial dimensions of the first bunching structure 312 and the second bunching structure 313 is conducive to the distal end of the first flexible wire 32 making a 360-degree turn relative to the proximal end of the connector 31, and the proximal end of the second flexible wire 33 making a 360-degree turn relative to the distal end of the connector 31, so that the first flexible wire 32, the connector 31 and the second flexible wire 33 can be bent at any angle, so that there is a higher degree of freedom between the first occluding disk 10 and the second occluding disk 20, so that the angle between the first occluding disk 10 and the second occluding disk 20 can be arbitrarily adjusted, which is conducive to the occluder 100 adapting to the shape and size of the heart tissue.

[0060] In some exemplary embodiments, Figure 3As shown, the connector 31 includes a main body 314 and a first bunching structure 312 and a second bunching structure 313 provided at both ends of the main body 314. From a front view perspective, the main body 314 is rectangular in shape, and the width dimensions (i.e., the dimensions in the radial direction) of the first bunching structure 312 and the second bunching structure 313 are gradually changed. A head is provided at the end of the first bunching structure 312 and the second bunching structure 313, and the head is the end where the filaments in the connector 31 converge. Figure 2 As shown, when viewed from the left, the connecting member 31 has a wavy structure as a whole.

[0061] In some exemplary embodiments, Figure 6 As shown, in the front view, the connector 31 is in a rhombus shape, with seals provided at two opposite acute angles of the rhombus. In the left view, the connector 31 is in a wavy structure.

[0062] In some exemplary embodiments, Figure 7 As shown, in the front view, the connector 31 is rectangular in shape, with seals provided at two opposite right angles of the rectangle. In the left view, the connector 31 is wavy in shape.

[0063] In some embodiments, please combine Figure 1 、 Figure 3 and Figure 10 As shown, in the expanded state, along the axial direction, the connector 31 includes a plurality of sequentially connected bending structures 311. The plurality of continuous bending structures 311 give the connector 31 a wavy structure. The connector 31 includes at least one wave cycle, and each wave cycle includes a crest and a trough. When the occluder 100 is used to block the foramen ovale, the crest in a wave cycle abuts against the primary septum 201, and the trough abuts against the secondary septum 202. In this embodiment, the endothelial cells in the primary septum 201 and the secondary septum 202 rapidly endothelialize using the mesh structure of the connector 31 between the crest and the trough as an attachment, quickly forming an endothelial membrane layer between the primary septum 201 and the secondary septum 202 to block the foramen ovale, thereby quickly achieving occlusion of the foramen ovale.

[0064] Furthermore, connector 31 comprises multiple, densely arranged, continuous wave periods. Upon release, the multiple, continuous bends 311 expand and deform, causing the crests and troughs of connector 31 to cling tightly to the foramen ovale wall, creating a larger contact area and enhancing endothelial coverage. Furthermore, the dense, wavy mesh structure of connector 31 allows for rapid endothelialization within the septum.

[0065] In an exemplary embodiment, the length of each wave period along the axial direction ranges from 1 mm to 2 mm, so that the connecting member 31 has more wave periods per unit length, thereby increasing the contact area between the connecting member 31 and the wall of the oval foramen per unit length.

[0066] In other embodiments, the entire connector may also be any one of a spiral structure, a broken line structure, an arc structure, or a regular spiral surface structure, or a combination of multiple structures.

[0067] In this embodiment, if Figures 3 to 5 As shown, the first occluding disk 10 and the second occluding disk 20 are both mesh disk structures with shape memory made of nickel-titanium wire. The proximal end of the first occluding disk 10 is provided with a first head 12, which is the end where the first occluding disk 10 wire bundles converge. The distal end of the second occluding disk 20 is provided with a second head 22, which is the end where the second occluding disk 20 wire bundles converge. The distal end of the first occluding disk 10 is provided with a first bolt head 11, which is connected to the first buckle 341 (please refer to Figure 9 ) is fixedly connected. The proximal end of the second blocking disk 20 is provided with a second bolt head 21, and the first buckle 341 of the second bolt head 21 is fixedly connected. In this embodiment, Figure 9 As shown, the proximal end of the first head 12 is provided with a threaded hole 121 (see Figure 9 ), and the threaded hole 121 is used to connect to the threaded end of the conveyor cable assembly. The first and second occluding disks 10, 20 may also be provided with a flow-blocking membrane to block blood flow, thereby achieving the sealing effect of the first and second occluding disks 10, 20. In other embodiments, the first plug 11 and / or the second plug 21 may not be provided.

[0068] According to an embodiment of the present invention, a occlusion system is further provided. The occlusion system includes a conveyor and an occluder, wherein the occluder can be conveyed to a target location via the conveyor.

[0069] The defect caused by a patent foramen ovale is a narrow, long gap, and the spacing of the gap varies from person to person. The occluder disc tends to form a certain angle with the gap. The larger the space formed by the angle, the higher the risk of thrombosis, and residual shunt is more likely to occur after occlusion. The following example illustrates the process of implanting the occluder into the foramen ovale:

[0070] 1. Determine the size of the foramen ovale and select an occluder that matches the size of the foramen ovale;

[0071] 2. Connect the threaded end of the delivery cable assembly in the conveyor to the threaded hole of the first head of the occluder;

[0072] 3. Insert the occluder into the catheter and push the delivery cable assembly so that the occluder moves along the catheter into the patent foramen ovale defect;

[0073] 4. Push the occluder to release and deploy the second occluding disc in the left atrium. Continue to release the connector in the connecting assembly to release and deploy it. After the wavy connector is firmly placed in the narrow gap between the septa, continue to release the first occluding disc to deploy it in the right atrium. As the connector shrinks in axial length, the first and second occluding discs are tightly attached to the septal surface.

[0074] 5. Rotate the delivery cable assembly to gradually loosen the thread of the delivery cable assembly and the first head of the occluder. When the delivery cable assembly completely releases the occluder, the delivery cable assembly can be withdrawn;

[0075] 6. Pull the delivery cable assembly to retract it from the catheter, and finally retract the catheter to complete the operation.

[0076] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present invention should be included in the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be based on the scope of protection of the claims.

Claims

1. A plugging device for plugging a hole-shaped channel, characterized in that: The occluder comprises: First blocking disk; a second occluding disk, located on one side of the distal end of the first occluding disk; A connecting component is arranged between the first occluding disk and the second occluding disk and is respectively connected to the first occluding disk and the second occluding disk. The connecting component includes a connecting member, which is an elastic member with a mesh structure and has a compressed state and an expanded state. In the compressed state, the connecting member is a strip-shaped member with a certain width under the main viewing angle. In the expanded state, the connecting member is bent along the axial direction under the left viewing angle to form at least one bent structure. The bent structure is offset from the inner wall of the porous channel to increase the contact area between the connecting member and the inner wall of the porous channel, thereby accelerating endothelialization to enhance the sealing effect.

2. The occluder according to claim 1, characterized in that: The radial dimension of the connecting member in the expanded state is greater than the radial dimension of the connecting member in the compressed state, and / or the axial dimension of the connecting member in the expanded state is smaller than the axial dimension of the connecting member in the compressed state.

3. The occluder according to claim 1, characterized in that: The connection assembly further includes a first flexible wire and / or a second flexible wire, the proximal end of the connection member is connected to the first occluding disk via the first flexible wire, and the distal end of the connection member is connected to the second occluding disk via the second flexible wire.

4. The occluder according to claim 1, characterized in that The occluder further comprises: a first universal mechanism, comprising a first buckle provided at a distal end of the first blocking disk and a first ball rotatably provided on the first buckle, wherein the first ball is connected to the connecting assembly; and / or The second universal mechanism includes a second buckle provided at the proximal end of the second occluding disk and a second ball rotatably provided on the second buckle, and the second ball is connected to the connecting assembly.

5. The occluder according to claim 1, characterized in that: The proximal end of the connecting member is provided with a first convergence structure, and the radial dimension of the first convergence structure gradually decreases from the distal end to the proximal end; and / or A second convergence structure is provided at the distal end of the connecting member, and the radial dimension of the second convergence structure gradually decreases from the proximal end to the distal end.

6. The occluder according to claim 1, characterized in that: The connection component further includes: a first rope loop movably disposed on a proximal end of the connecting member; and / or A second rope loop is movably arranged on the distal end of the connecting member.

7. The occluder according to claim 1, characterized in that: The porosity of the connecting piece ranges from 10% to 30%.

8. The occluder according to claim 1, characterized in that: In the expanded state, along the axial direction from a left-side viewing angle, the connecting member includes a plurality of bending structures connected in sequence, so that the connecting member as a whole has an arc-shaped structure, a wavy structure, or a broken line structure.

9. The occluder according to claim 8, characterized in that: When the connecting member has a wavy structure, the connecting member includes at least one wave period, each wave period includes a wave crest and a wave trough, and along the axial direction, the length of each wave period ranges from 1 mm to 2 mm.

10. A blocking system, characterized in that: The occluder comprises a conveyor and the occluder according to any one of claims 1 to 9, wherein the occluder can be conveyed to a target position via the conveyor.

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