Occluder and occlusion system

Abstract

The present invention relates to an occluder and an occluding system, wherein the occluder comprises: a first occluding disc; a second occluding disc located on one side of the distal end of the first occluding disc; a connecting assembly located between and connected to the first and second occluding discs, the connecting assembly comprising a connecting portion and a mating portion spaced axially apart; and an adjusting assembly fixedly connected to the connecting portion, the adjusting assembly comprising a mating piece that can be unidirectionally inserted into and fixed to the mating portion. Pulling the adjusting assembly brings the connecting portion and the mating portion closer together, thereby reducing the total axial length of the connecting assembly. The present invention aims to provide an occluder with adjustable length.

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 of this channel varies significantly from person to person. Therefore, adjusting the length of the waist connector to accommodate foramen ovale of varying lengths and to avoid residual shunt after occlusion due to poor adhesion of the left and right discs remains a pressing issue. Summary of the Invention

[0004] In view of the above problems, the present invention aims to provide an occluder with an adjustable length of a connecting component.

[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 assembly, located 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 assembly including a connecting portion and a matching portion spaced apart along the axial direction; an adjusting assembly, fixedly connected to the connecting portion, the adjusting assembly including a matching piece, the matching piece can be unidirectionally penetrated into the matching portion and fixed, and the connecting portion and the matching portion are driven closer to each other by pulling the adjusting assembly, thereby reducing the total axial length of the connecting assembly.

[0007] In some embodiments of the present invention, the mating portion includes a stop portion and a limiting hole provided in the stop portion, the adjustment assembly is passed through the limiting hole, and the mating part includes at least one stop portion, which can pass through the limiting hole when moving along a first direction, and is blocked by the stop portion when moving along a second direction; wherein, the first direction is opposite to the second direction, and when the stop portion moves along the first direction, the connecting portion and the mating portion approach each other.

[0008] In some embodiments of the present invention, the adjustment component includes: a flexible traction wire, which is passed through the limiting hole, and one end of the flexible traction wire is fixedly connected to the connecting part; and a plurality of stoppers, which are fixed on the flexible traction wire in sequence and at intervals.

[0009] In some embodiments of the present invention, the stop member is an elastic member that can be elastically deformed, and the stop member includes a first end and a second end. Along the first direction, the first end of the stop member is connected to the flexible traction wire, and a guide surface inclined relative to the axis of the flexible traction wire is defined between the first end and the second end. When the stop member moves along the first direction, the stop member is compressed by the cooperation between the guide surface and the limiting hole, so that the stop member passes through the limiting hole.

[0010] In some embodiments of the present invention, the stopper is a mesh woven from nickel-titanium wires, and the mesh is triangular or conical; or the stopper is a V-shaped rod.

[0011] In some embodiments of the present invention, the connecting component includes a connecting member, the proximal end of which is connected to the distal end of the first flexible wire, the connecting member is an elastic member in a strip shape and has a compressed state and an expanded state, and 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.

[0012] In some embodiments of the present invention, the connection assembly further comprises 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.

[0013] In some embodiments of the present invention, the occluder further includes: a first universal mechanism, the first universal mechanism including a first buckle provided at the distal end of the first occluding disk and a first ball rotatably provided on the first buckle, the first ball being connected to the connecting assembly; and / or, a second universal mechanism, the second universal mechanism including a second buckle provided at the proximal end of the second occluding disk and a second ball rotatably provided on the second buckle, the second ball being connected to the connecting assembly.

[0014] In some embodiments of the present invention, the connecting assembly includes a connecting piece, and the occluder also includes a first universal mechanism. The connecting piece is a strip-shaped elastic piece and has a compressed state and an expanded state. In the expanded state, the connecting piece includes at least one bending structure, and the bending structure is against the inner wall of the porous channel. The first universal mechanism includes a first buckle provided at the distal end of the first occluding disk and a first ball rotatably provided on the first buckle. The first ball is connected to the connecting assembly, and the connecting part is located at the distal end of the connecting piece. The first ball is set as a hollow structure and is provided with the limiting hole to form the stop part.

[0015] In some embodiments of the present invention, the limiting holes and the wire outlet holes are respectively provided at different positions of the first ball, a roller is provided inside the first ball, both ends of the roller are rotatably provided on the inner wall of the first ball, and part of the adjustment component is wrapped around the roller and the proximal end extends from the wire outlet hole.

[0016] In some embodiments of the present invention, the connecting member is in a mesh shape. In the expanded state, along the axial direction, the connecting member includes a plurality of bending structures connected in sequence, so that the connecting member has a wavy structure and includes at least one wave period, and each wave period includes a crest and a trough; wherein the adjustment component is arranged in the mesh of the mesh surface of the connecting member between at least one crest or trough.

[0017] 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.

[0018] The occluder of the present invention drives the connecting portion to move unidirectionally by pulling the adjusting component, so that the connecting portion and the matching portion are close to each other in the axial direction, thereby reducing the axial length of the connecting component between the connecting portion and the matching portion, and the matching piece can be penetrated into the matching portion in one direction and fixed, thereby reducing the total length of the connecting component in the axial direction, so as to facilitate the occluder to adapt to foramen ovale of different lengths, so that the first occluding disk and the second occluding disk are better attached to the two ends of the foramen ovale, and effectively block the patent foramen ovale. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] 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:

[0020] Figure 1 Schematically shows a schematic diagram of an occluder blocking a hole-shaped channel according to an embodiment of the present invention, without showing an adjustment component;

[0021] Figure 2 Schematically shows a structural diagram of an occluder from a left perspective according to an embodiment of the present invention;

[0022] Figure 3 Schematically shows a structural diagram of an occluder from a main viewing angle according to an embodiment of the present invention;

[0023] Figure 4 Schematically shows a schematic structural diagram of an occluder according to an embodiment of the present invention from a top view;

[0024] Figure 5 Schematically shows a structural diagram of an occluder according to an embodiment of the present invention from a bottom-up perspective;

[0025] Figure 6 Schematically shows a structural diagram of a connector according to an embodiment of the present invention from a main viewing angle;

[0026] Figure 7 Schematically shows a structural diagram of a connector according to an embodiment of the present invention from a main viewing angle;

[0027] Figure 8 Schematically shows a cross-sectional structural diagram of a second universal joint according to an embodiment of the present invention;

[0028] Figure 9 Schematically shows a cross-sectional structural diagram of a first occluding disk according to an embodiment of the present invention;

[0029] Figure 10Schematically shows a schematic diagram of an occluder blocking a hole-shaped channel according to an embodiment of the present invention, without showing an adjustment component;

[0030] Figure 11 Schematically shows a structural diagram of a connecting member and an adjusting assembly according to a first embodiment of the present invention;

[0031] Figure 12 Schematically shows a partial structural diagram of a connecting member and an adjusting assembly according to a first embodiment of the present invention;

[0032] Figure 13 Schematically shows a partial structural diagram of an adjustment component according to an embodiment of the present invention;

[0033] Figure 14 Schematically shows a partial structural diagram of an adjustment component according to a third embodiment of the present invention;

[0034] Figure 15 Schematically shows a partial structural diagram of an adjustment component according to a second embodiment of the present invention;

[0035] The reference numerals are as follows:

[0036] 100-occluder;

[0037] 10-first sealing disk, 11-first bolt head, 12-first sealing head, 121-threaded hole;

[0038] 20-second sealing disk, 21-second plug head, 22-second sealing head;

[0039] 30-connecting assembly, 31-connecting member, 311-bending structure, 312-first bundling structure, 313-second bundling structure, 314-main body, 315-connecting portion, 32-first flexible wire, 33-second flexible wire, 34-first universal mechanism, 341-first buckle, 342-first ball, 343-outlet hole, 344-roller, 35-second universal mechanism, 351-second buckle, 352-second ball, 36-first rope loop, 37-second rope loop; 38-matching portion, 381-stop portion, 382-limiting hole;

[0040] 40 - adjustment assembly, 41 - flexible traction wire, 42 - stopper, 421 - guide surface, 422 - first rod portion, 423 - second rod portion, 424 - first end, 425 - second end;

[0041] 200-porous channel;

[0042] 201-primary septum, 202-secondary septum. DETAILED DESCRIPTION

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] Please combine Figure 1 and Figure 2 As shown, according to an embodiment of the present invention, an occluder 100 is proposed.

[0049] The occluder 100 includes a first occluding disk 10, a second occluding disk 20, a connecting assembly 30, and an adjusting assembly 40. The connecting assembly 30 is located between the first occluding disk 10 and the second occluding disk 20, and is connected to the first occluding disk 10 and the second occluding disk 20 respectively. The adjusting assembly 40 is provided on the connecting assembly 30, and the connecting assembly 30 has a connecting portion 315 and a matching portion 38. The connecting portion 315 and the matching portion 38 are arranged spaced apart in the axial direction. The adjusting assembly 40 and the connecting portion 315 are fixedly connected. The adjusting component 40 is also provided with a fitting part that cooperates with the fitting part 38. The fitting part can be inserted into the fitting part 38 in one direction and fixed. By pulling the adjusting component 40, the connecting part 315 and the fitting part 38 in the connecting component 30 are driven closer to each other to reduce the axial distance between the connecting part 315 and the fitting part 38, that is, the axial length of the connecting component 30 between the connecting part 315 and the fitting part 38 is reduced, thereby reducing the total length of the connecting component 30 in the axial direction, so as to facilitate the occluder to adapt to the oval foramen of different lengths, so that the first occluding disk 10 and the second occluding disk 20 are better attached to the two ends of the oval foramen, effectively sealing the patent foramen ovale.

[0050] It should be noted that the direction in which the adjustment assembly 40 is pulled to cause the connection assembly 30 to move unidirectionally is the direction that reduces the axial distance between the connection portion 315 and the mating portion 38. Specifically, if the connection portion 315 is located distally relative to the mating portion 38, the adjustment assembly 40 can move proximally relative to the connection assembly 30; if the connection portion 315 is located proximally relative to the mating portion 38, the adjustment assembly 40 can move distally relative to the connection assembly 30. Furthermore, after the adjustment assembly 40 is driven to cause the connection assembly 30 to move to reduce its total axial length, the mating portion 38 is further configured to prevent the mating portion from moving in the opposite direction, preventing the connection assembly 30 from returning to its pre-adjustment length.

[0051] In this embodiment, the matching portion 38 and the matching piece together constitute a one-way movement mechanism to limit the movement direction of the adjustment assembly 40 relative to the connecting assembly 30 .

[0052] In some embodiments, as Figure 11 and Figure 12 As shown, the mating portion 38 includes a stopper 381 and a limiting hole 382 provided therein. The adjustment assembly 40 is disposed within the limiting hole 382 and is movable within the limiting hole 382. The mating component includes at least one stopper 42, which can pass through the limiting hole 382 in one direction. Specifically, the stopper 42 can pass through the limiting hole 382 when moving in a first direction and is blocked by the stopper when moving in a second direction. The first direction is opposite to the second direction, and when the stopper moves in the first direction, the connecting portion 315 and the mating portion 38 approach each other.

[0053] It should be noted that the first direction is jointly defined based on the axial direction of the limiting hole and the relative position between the connecting portion 315 and the matching portion 38. For example, if the axis of the limiting hole extends axially and the connecting portion 315 is located on the distal side relative to the matching portion 38, then the first direction is the direction along the axial direction and toward the proximal side, and the second direction is opposite to the first direction, then the second direction is the direction along the axial direction and toward the distal side; if the axis of the limiting hole extends axially and the connecting portion 315 is located on the proximal side relative to the matching portion 38, then the first direction is the direction along the axial direction and toward the distal side, and the second direction is opposite to the first direction, then the second direction is the direction along the axial direction and toward the proximal side.

[0054] It is understandable that the mating portion 38 and the mating piece can be set to various structural forms, as long as they can limit the unidirectional movement of the adjustment component 40 relative to the connecting component 30. The technical solution of the present invention will be further described in detail below in conjunction with specific implementation methods.

[0055] Implementation Method 1

[0056] In this embodiment, the occluder 100 includes a first occluding disk 10 , a second occluding disk 20 , a connecting assembly 30 , and an adjusting assembly 40 .

[0057] 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.

[0058] Please combine Figure 1 and Figure 2As shown, the connection assembly 30 includes a connector 31, 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 through the first flexible wire 32, and the distal end of the connector 31 is connected to the second occluding disk 20 through 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 the complex physiological environment, any one of the first occluding disk 10 and the second occluding disk 20 adaptively adjusts its own position and angle, and will not affect the other one of the first occluding disk 10 and the second occluding disk 20, thereby ensuring the relative independence of the first occluding disk 10 and the second occluding disk 20, and being able to adapt to the complex physiological environment more flexibly and better achieve occlusion. Among them, the wire diameters of the first flexible wire 32 and the second flexible wire 33 can be the same or different. In other embodiments, the connecting component 30 may include any one of the first flexible wire 32 or the second flexible wire 33. Alternatively, the connecting component 30 may also not include the first flexible wire 32 and the second flexible wire 33.

[0059] The connector 31 is a strip-shaped elastically deformable elastic member. The connector 31 has a compressed state and an expanded state. In the compressed state, the connector 31 is contracted to a sheath of corresponding specifications. After the second occluding disc 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 a plurality of continuous bending structures 311. The plurality of continuous bending structures 311 make the connector 31 have 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 occlude the foramen ovale, the crest in a wave cycle offsets the primary septum 201, and the trough offsets the secondary septum 202. In this embodiment, the endothelial cells in the primary septum 201 and the secondary septum 202 rapidly endothelialize using the connector 31 between the crest and 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 closure of the foramen ovale. The connector 31 includes multiple continuous wave periods, and the wave periods are arranged relatively densely. After the connector 31 is released, the multiple continuous bending structures 311 expand and deform, causing the crest and trough surfaces of the connector 31 to adhere closely to the wall of the foramen ovale, forming a large contact area, thereby improving the efficiency of endothelial climbing. The band-like shape can be understood as the connector 31 having a certain width in the radial direction, so that each bending structure of the connector 31 is in line contact or surface contact with the porous channel 200.

[0060] In this 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.

[0061] In other embodiments, the entire connecting member 31 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.

[0062] In this embodiment, the connector 31 is a shape-memory mesh woven from nickel-titanium wire. The porosity of the connector 31 ranges from 10% to 30%, for example, 10%, 14%, 18%, 20%, 25%, 30%, etc. The porous mesh structure allows for rapid endothelialization within the pores of the connector 31, thereby facilitating rapid closure of the porous channel 200. The ratio of the area of all pores per unit area of the connector 31 is denoted by the percentage of the total area of the pores per unit area of the connector 31. Furthermore, the wavy, dense mesh structure of the connector 31 allows for rapid endothelialization within the septum.

[0063] It should be noted that 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, so that after the connector 31 is completely released, the length of the connector 31 in the axial direction 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), thereby utilizing the elastic force of the connector 31 to tighten the first and second sealing disks 10 and 20 through the first and second flexible wires 32 and 33, respectively, to provide 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 two 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.

[0064] It can be understood that after the connector 31 is released, it can spontaneously expand and deform, so that the connector 31 can fit the inner wall of the porous channel 200. Moreover, based on the elastic characteristics of the connector 31, the connector 31 has a certain deformation margin, so that the connector 31 can adapt to porous channels 200 of different widths and improve the wall adhesion effect of the connector 31.

[0065] 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 similar to 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.

[0066] In some embodiments, as Figure 3 As shown, in order to further improve the degree of freedom between the first blocking disk 10, the second blocking disk 20 and the connecting assembly 30, the connecting assembly 30 also includes a first rope loop 36 and a second rope loop 37, both of which are annular. The first rope loop 36 is inserted through the proximal end of the connecting member 31 and can rotate relative to the connecting member 31. The proximal end of the first flexible wire 32 is welded to the first ball 342, and the distal end of the first flexible wire 32 is connected to the first rope loop 36, so that the connecting member 31 and the first flexible wire 32 are firmly connected while ensuring that the connection maintains a large degree of freedom. The second rope loop 37 is inserted through the distal end of the connecting member 31 and can rotate relative to the connecting member 31. The distal end of the second flexible wire 33 is welded to the second ball 352, and the proximal end of the second flexible wire 33 is connected to the second rope loop 37, so that the connecting member 31 and the second flexible wire 33 are firmly connected while ensuring that the connection maintains a large degree of freedom.

[0067] 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.

[0068] 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 .

[0069] 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.

[0070] 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.

[0071] 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.

[0072] In some exemplary embodiments, Figure 3As shown, the connector 31 includes a main body 314 and a first and second converging structures 312 and 313 disposed at either end of the main body 314. When viewed from the front, the main body 314 is rectangular, with the first and second converging structures 312 and 313 having gradually varying widths (i.e., radial dimensions). End caps are provided at the ends of the first and second converging structures 312 and 313, representing the end where the filaments in the connector 31 converge. When viewed from the left, the connector 31 has an overall wavy structure.

[0073] 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.

[0074] 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.

[0075] In this embodiment, please combine Figure 2 、 Figure 11 and Figure 12 As shown, the connecting portion 315 is provided at the distal end of the connecting member 31, and the stop portion 381 is provided at the proximal end of the connecting member 31. The stop portion 381 is a plate-like or block-like structure or annular structure provided at the proximal end of the connecting member 31, and the limiting hole 382 extends along the axial direction. The adjustment component 40 includes a flexible traction wire 41 and a plurality of stoppers 42. The distal end of the flexible traction wire 41 is fixedly connected to the connecting portion 315, and the proximal end of the flexible traction wire 41 is passed through the limiting hole 382, and a plurality of stoppers 42 are provided on the flexible traction wire 41 near the side of the limiting hole 382 and are fixed on the flexible traction wire 41 in sequence and at intervals. The stopper 42 is a mesh member woven and shaped by nickel-titanium wire, and the stopper 42 is an elastic member that can be elastically deformed. The stopper 42 can shrink under the action of an external force, and expand and recover when the external force is lost. Among them, the flexible traction wire 41 can be a flexible metal wire or a suture. In this embodiment, refer to Figure 12 The stop portion 381 is connected to the side of the proximal end of the connector 31. In other embodiments, the stop portion 381 is directly connected to the proximal end of the connector 31. In this case, the stop portion 381 is formed by two annular structures arranged inside and outside. The proximal end of the connector 31 is connected between the two annular structures, and the internal annular structure constitutes a limiting hole 382.

[0076] In other embodiments, the connection portion 315 is provided at the proximal end of the connector 31, the stop portion 381 is provided at the proximal end of the connector 31, one end of the flexible traction wire 41 is connected to the connection portion 315, and the other end of the flexible traction wire 41 first passes through the connector 31, then passes through the stop portion 381, and then extends toward the proximal end. A plurality of stop members 42 are provided near the stop portion 381 of the flexible traction wire 41 to achieve the function of fixing the stop member 42 through the stop portion 381.

[0077] Specifically, if Figure 12 and Figure 13 As shown, along the first direction, the first end 424 of the stopper 42 (i.e., the proximal end of the stopper 42) is connected to the flexible traction wire 41, and a guide surface 421 inclined relative to the axis of the flexible traction wire 41 is defined between the first end 424 and the second end 425, that is, the stopper 42 is in the shape of an inverted triangle or a cone, the first end 424 of the stopper 42 is the apex of the triangle or the cone, and the second end 425 of the stopper 42 is the side of the triangle or the bottom surface of the cone. When the stopper 42 moves along the first direction, the sharper first end 424 first enters the limiting hole 382. When the stopper 42 continues to move, the wall of the limiting hole 382 applies pressure to the guide surface 421, and the stopper 42 contracts under the action of pressure to completely enter and pass through the limiting hole 382. It should be noted that the radial dimension of the first end 424 of the stop member 42 is smaller than the diameter of the limiting hole 382, and the radial dimension of the second end 425 of the stop member 42 is larger than the diameter of the limiting hole 382. When the stop member 42 moves along the second direction, the second end 425 of the stop member 42 (that is, the base of the triangle or the bottom surface of the cone) directly abuts against the stop portion 381. Since the radial dimension of the second end 425 of the stop member 42 is larger than the diameter of the limiting hole 382, the stop member 42 cannot enter the limiting hole 382, thereby limiting the stop member 42 and even the adjustment component 40 from continuing to move along the second direction.

[0078] In this embodiment, after the first sealing disk 10, the connecting assembly and the second sealing disk 20 are released, if the axial length of the connecting member 31 in the expanded state is large, the overall axial size of the connecting assembly is long, resulting in insufficient pre-tightening force between the first sealing disk 10 and the second sealing disk 20 and the two ends of the foramen ovale or even a loose fit, the proximal end of the flexible traction wire 41 can be pulled toward the proximal side to allow at least one stopper 42 to pass through the limiting hole 382, thereby reducing the length of the flexible traction wire 41 between the connecting portion 315 and the stopper 381, thereby producing an effect of axially compressing the connecting member 31, reducing the axial length of the connecting member 31, and thereby reducing the total axial length of the connecting assembly, providing sufficient pre-tightening tension for the first sealing disk 10 and the second sealing disk 20, so that the first sealing disk 10 and the second sealing disk 20 have a better wall-adhering effect, thereby improving the sealing effect of the foramen ovale.

[0079] Implementation Method 2

[0080] The structures of the first sealing disk, the second sealing disk, the connecting assembly and the adjusting assembly in this embodiment are basically the same as those of the first sealing disk, the second sealing disk, the connecting assembly and the adjusting assembly in embodiment one. The difference lies in the structure and setting position of the stopper. The differences between embodiment two and embodiment one will be described below, and the similarities or similarities between embodiment two and embodiment one will not be repeated here.

[0081] In this embodiment, please combine Figure 2 、 Figure 9 and Figure 15 As shown, the first ball 342 is configured as a hollow structure and is provided with a limiting hole 382 to form a stopper 381. The limiting hole 382 is provided on the side of the first ball 342 facing the distal end. The interior of the first ball 342 forms a receiving space for the stopper 42. During the adjustment process, the stopper 42 can be retracted into the interior of the first ball 342 through the limiting hole 382 to prevent the stopper 42 from interfering with the connector 31 or the first flexible wire after the occluder is released, thereby preventing the occluder from interfering with the connector 31 or the first flexible wire, thereby affecting the occluding effect of the occluder.

[0082] In some embodiments, in order to facilitate the accommodation of more stoppers 42 inside the first ball 342 to increase the adjustment length of the adjustment assembly 40, the first ball 342 is respectively provided with a limit hole 382 and a wire outlet hole 343 at different positions, and a roller 344 is provided inside the first ball 342. The two ends of the roller 344 are rotatably provided on the inner wall of the first ball 342. The flexible traction wire 41 is wound around the roller 344 and the proximal end extends from the wire outlet hole 343. In addition, the flexible traction wire 41 is wound around the roller 344 for multiple turns. When the flexible traction wire 41 is pulled toward the proximal end, multiple stoppers 42 can be stacked and wound on the rotating shaft.

[0083] Implementation Method 3

[0084] The structures of the first sealing disk, the second sealing disk, the connecting assembly and the adjusting assembly in this embodiment are basically the same as the structures of the first sealing disk, the second sealing disk, the connecting assembly and the adjusting assembly in embodiment one or embodiment two. The difference lies in the structure of the stopper. The differences between embodiment three and embodiment one or embodiment two will be described below, and the similarities or similarities between embodiment three and embodiment one or embodiment two will not be repeated here.

[0085] In this embodiment, if Figure 14As shown, the stopper 42 is an elastic rod-shaped member, and the stopper 42 is in a V-shaped shape as a whole. The stopper 42 includes a first rod portion 422 and a second rod portion 423. The proximal ends of the first rod portion 422 and the second rod portion 423 are connected, and along the first direction, the first ends 424 of the first rod portion 422 and the second rod portion 423 (that is, the proximal ends of the first rod portion 422 and the second rod portion 423) are connected to the flexible traction wire 41, and the first rod portion 422 and the second rod portion 423 are both inclined relative to the axis of the flexible traction wire 41, that is, the first The rod portion 422 and the second rod portion 423 form a guide surface 421 on one side facing the first end 424. When the stop member 42 moves along the first direction, the sharper first end 424 first enters the limiting hole (not shown in the figure). When the stop member 42 continues to move, the hole wall of the limiting hole applies pressure to the first rod portion 422 and the second rod portion 423 through the guide surface 421. Under the action of pressure, the distal ends of the first rod portion 422 and the second rod portion 423 are bent toward the direction close to the axis of the flexible traction wire 41 so as to completely enter and pass through the limiting hole. It should be noted that the radial dimension of the first end 424 of the stop member 42 is smaller than the diameter of the limiting hole, and the radial dimension of the second end 425 of the stop member 42 (i.e., the distance between the distal end of the first rod portion 422 and the distal end of the second rod portion 423) is larger than the diameter of the limiting hole. When the stop member 42 moves along the second direction, the distal end of the first rod portion 422 and the distal end of the second rod portion 423 directly abut against the stop portion (not shown in the figure). Since the radial dimension of the second end 425 of the stop member 42 is larger than the diameter of the limiting hole, the stop member 42 cannot enter the limiting hole, thereby limiting the stop member 42 and even the adjustment component 40 from continuing to move along the second direction.

[0086] In this embodiment, in order to avoid the first rod portion 422 and the second rod portion 423 from piercing the heart tissue, the first rod portion 422 and the second rod portion 423 are both configured to be arc-shaped and bent toward the axis direction of the flexible traction wire 41, so that the distal end of the first rod portion 422 and the distal end of the second rod portion 423 are bent toward the axis of the flexible traction wire 41.

[0087] 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.

[0088] In this embodiment, if Figure 3 、 Figure 4 and Figure 5As shown, the first sealing disk 10 and the second sealing disk 20 are both mesh disk structures with shape memory woven from nickel-titanium wires. The proximal end of the first sealing disk 10 is provided with a first head 12, and the first head 12 is the end where the wire bundles of the first sealing disk 10 converge. The distal end of the second sealing disk 20 is provided with a second head 22, and the second head 22 is the end where the wire bundles of the second sealing disk 20 converge. The distal end of the first sealing disk 10 is provided with a first bolt head 11, and the first bolt head 11 is fixedly connected to the first buckle 341. The proximal end of the second sealing disk 20 is provided with a second bolt head 21, and the second bolt head 21 is fixedly connected to the second buckle 351. In this embodiment, as Figure 9 As shown, the proximal end of the first sealing head 12 is provided with a threaded hole 121 for connecting to the threaded end of the conveyor cable assembly. The first and second sealing discs 10, 20 may be provided with flow-blocking membranes to block blood flow, thereby achieving the sealing effect of the first and second sealing discs 10, 20. In other embodiments, the first plug head 11 and / or the second plug head 21 may not be provided.

[0089] 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:

[0090] 1. Determine the size of the foramen ovale and select an occluder that matches the size of the foramen ovale;

[0091] 2. Connect the threaded end of the delivery cable assembly in the conveyor to the threaded hole of the first head of the occluder;

[0092] 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;

[0093] 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.

[0094] 5. Pull the proximal end of the flexible traction wire to move it toward the proximal end to adjust the total axial length of the connecting assembly. Deliver the wire cutter along the sheath into the body to cut off the excess flexible traction wire or remove it by hydraulic release, electrolytic release, thermal melt release, etc., and withdraw it from the body.

[0095] 6. Rotate the delivery cable assembly to gradually loosen the threads 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.

[0096] 7. Pull the delivery cable assembly to retract it from the catheter, and finally retract the catheter to complete the operation.

[0097] 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. An occluder, 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 located between the first occluding disk and the second occluding disk and is connected to the first occluding disk and the second occluding disk respectively, the connecting component includes a connecting portion and a matching portion spaced apart in the axial direction, the connecting component includes a connecting piece, the connecting piece is an elastic piece of a mesh belt-like structure and has a compressed state and an expanded state, in the main viewing angle, the belt-like shape is defined as a certain width in the radial direction of the connecting piece, in the expanded state, in the axial direction in the left viewing angle, the connecting piece includes a plurality of bent structures connected in sequence, the bent structure abuts against the inner wall of the porous channel to form surface contact to form a larger area contact, so as to improve the endothelial climbing efficiency; An adjusting assembly is fixedly connected to the connecting portion. The adjusting assembly includes a fitting, which can be inserted into the fitting portion in one direction and fixed. By pulling the adjusting assembly, the connecting portion and the fitting portion are driven closer to each other, thereby reducing the total axial length of the connecting assembly.

2. The occluder according to claim 1, characterized in that: The matching portion includes a stop portion and a limiting hole provided in the stop portion, the adjustment assembly is passed through the limiting hole, and the matching member includes at least one stop member, the stop member can pass through the limiting hole when moving along the first direction, and is blocked by the stop portion when moving along the second direction; The first direction is opposite to the second direction, and when the stopper moves along the first direction, the connecting portion and the matching portion approach each other.

3. The occluder according to claim 2, characterized in that: The adjustment component includes: A flexible traction wire is passed through the limiting hole, and one end of the flexible traction wire is fixedly connected to the connecting portion; The plurality of stoppers are fixed on the flexible traction wire in sequence and at intervals.

4. The occluder according to claim 3, characterized in that: The stop member is an elastic member that can be elastically deformed. The stop member includes a first end and a second end. Along the first direction, the first end of the stop member is connected to the flexible traction wire, and a guide surface inclined relative to the axis of the flexible traction wire is defined between the first end and the second end. When the stop member moves along the first direction, the stop member is compressed by the cooperation between the guide surface and the limiting hole, so that the stop member passes through the limiting hole.

5. The occluder according to claim 4, characterized in that: The stopper is a mesh piece woven from nickel-titanium wires, and the mesh piece is triangular or conical; or The stopper is a V-shaped rod-shaped member.

6. 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.

7. 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.

8. The occluder according to claim 2, characterized in that: The occluder further includes a first universal mechanism, which includes a first buckle provided at the distal end of the first occluding disk and a first ball rotatably provided on the first buckle, wherein the first ball is connected to the connecting assembly. The connecting portion is located at the distal end of the connecting piece, and the first ball is configured as a hollow structure and is provided with the limiting hole to form the stopping portion.

9. The occluder according to claim 8, characterized in that: The first ball is provided with the limiting holes and the wire outlet holes at different positions respectively, a roller is provided inside the first ball, both ends of the roller are rotatably provided on the inner wall of the first ball, part of the adjustment component is wrapped around the roller and the proximal end extends from the wire outlet hole.

10. The occluder according to claim 1, characterized in that: The plurality of sequentially connected bending structures make the connecting member have a wave-shaped structure and include at least one wave period, and each wave period includes a wave crest and a wave trough; Wherein, the adjustment component is inserted into the mesh of the mesh surface of the connecting member between at least one crest or trough.

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

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