Plugging device for patent foramen ovale

Abstract

The utility model discloses a plugging device for patent foramen ovale. The plugging device comprises a plugging assembly and a conveying assembly. The plugging assembly comprises a fixed plugging piece, a movable plugging piece and a connecting rod; the conveying assembly comprises a pushing rod and a pushing rod sheath; the fixed plugging piece and the movable plugging piece are arranged on the two sides of the connecting rod respectively. A limiting part is arranged at the lower end of the connecting rod; the upper end of the pushing rod is movably locked with the limiting part of the connecting rod; the fixed plugging piece comprises a fixed ring and a first plugging structure; the fixed ring is fixedly connected with the upper end of the connecting rod; the movable plugging piece comprises a movable ring and a second plugging structure, and the movable ring moves in the axial direction of the connecting rod and is finally limited to the side, close to the fixed ring, of the limiting part. The first plugging structure is an elastic ring body or an elastic thorn body; correspondingly, the first plugging structure is an elastic thorn body or an elastic ring body; the pushing rod sheath is arranged outside the pushing rod in a sleeving mode in the axial direction of the pushing rod in a reciprocating motion mode and used for pushing the movable ring of the movable plugging piece to move upwards. Therefore, the operation process can be effectively guaranteed to be smoothly carried out.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a patent foramen ovale occlusion device. Background Art

[0002] Many recent studies have shown that patent foramen ovale is closely related to symptoms such as cryptogenic stroke, migraine, and dizziness. At present, the treatment options for these patients are generally divided into drug treatment and patent foramen ovale occlusion treatment. Data from multiple research centers at home and abroad show that the effect of occlusion is significantly better than drug treatment. Currently available types of patent foramen ovale occlusion umbrellas include: metal occlusion umbrellas (such as: Abbott's Amplatzer occlusion umbrella, Huayi Shengjie's cardi-o-fix, etc.), biodegradable occlusion umbrellas (such as: Shanghai Shape Memory Corporation's MemoSorb, etc.), all of which can well occlude the patent foramen ovale. However, metal occlusion umbrellas have many problems: such as residual shunt, metal allergy, release of metal ions, long endothelialization time, long-term presence of foreign bodies, shedding, displacement, hemolysis, abrasion of tissues, obstruction of the normal movement of the atrial septum, etc.; Currently, the MemoSorb biodegradable occlusion umbrella produced by Shanghai Shape Memory Corporation is used clinically; However, in the structure of this biodegradable occlusion umbrella, a locking device is required during the release process, and there is a problem of entanglement between the silk thread and the push rod in the locking device during use, which affects the normal progress of the operation. And the existing occlusion umbrellas usually adopt a self-expanding mesh structure, which is relatively large in size and inconvenient to use. Summary of the Utility Model

[0003] The purpose of the utility model is to provide a patent foramen ovale occlusion device, which can solve the above-mentioned entanglement problem during use, has the advantages of small size, convenient use, and can ensure the smooth progress of the operation.

[0004] To achieve the above object, the solution of the utility model is:

[0005] A patent foramen ovale occlusion device, comprising an occlusion component and a delivery component, wherein the occlusion component is made of a biodegradable material;

[0006] The occlusion component includes a fixed occlusion member, a movable occlusion member, and a connecting rod; the delivery component includes a push rod and a push rod outer sheath;

[0007] The fixed occlusion member and the movable occlusion member are respectively arranged on the upper and lower sides of the axial direction of the connecting rod; a limiting portion is provided at the lower end of the connecting rod, and the upper end of the push rod is movably locked to the end face of the limiting portion of the connecting rod;

[0008] The fixed plugging member includes a fixed ring and a first plugging structure, and the fixed ring is fixedly connected to the upper end of the connecting rod; the movable plugging member includes a movable ring and a second plugging structure, the movable ring is an elastic "C" - shaped structure, and the movable ring moves axially along the connecting rod and is finally limited to the side of the limiting portion close to the fixed ring;

[0009] The first plugging structure is an elastic ring body, and the second plugging structure is an elastic thorn body; or, the first plugging structure is an elastic thorn body, and the second plugging structure is an elastic ring body;

[0010] The elastic ring body includes an annular self - expanding body and a plurality of elastic rod bodies. The annular self - expanding body is connected to the fixed ring or the movable ring through each elastic rod body. The elastic ring body is compressed and closed, and automatically expands into a frustum shape when not compressed; the elastic thorn body includes a plurality of elastic thorn rods, and each elastic thorn body is compressed and closed, and automatically expands into a radial shape when not compressed;

[0011] The outer sheath of the push rod is sleeved on the push rod and reciprocates axially along the axis of the push rod. The upper end of the outer sheath of the push rod has a pushing portion, which is used to push the movable ring of the movable plugging member upward. The inner diameter of the pushing portion is larger than the outer diameter of the limiting portion.

[0012] Further, the annular self - expanding body is coaxially arranged with the connecting rod and is respectively connected to the fixed ring or the movable ring through the elastic rod bodies distributed at circumferential intervals. When the annular self - expanding body is compressed and shrunk, it drives each elastic rod body to close and adhere to the connecting rod or the push rod. When the annular self - expanding body is not compressed, it automatically expands and drives each elastic rod body to expand away from the connecting rod or the push rod, and the whole is in a frustum shape with the annular self - expanding body facing the direction of the elastic thorn body;

[0013] On each elastic thorn rod of the elastic thorn body, a plurality of fixing thorns are convexly provided. The elastic thorn rods are circumferentially distributed and connected to the outer periphery of the movable ring or the fixed ring. When each elastic thorn body is compressed, it adheres to the connecting rod or the push rod. When each elastic thorn body is not compressed, it automatically expands away from the connecting rod or the push rod, and the whole is in a radial shape with each fixing thorn facing the direction of the elastic ring body.

[0014] Further, the annular self - expanding body is composed of a plurality of "W" - shaped units distributed circumferentially.

[0015] Further, the top of the push rod has a push rod thread portion, and a threaded connection hole is formed on the bottom surface of the limiting portion at the lower end of the connecting rod. The push rod thread portion is in threaded cooperation with the threaded connection hole.

[0016] Further, the limiting portion is a frustum - shaped structure with a narrower bottom and a wider top, and a limiting step is formed on the top surface of the limiting portion.

[0017] Further, the outer sheath of the push rod and the push rod achieve axial reciprocating movement through threaded cooperation.

[0018] Further, the length of the push rod is greater than that of the outer sheath of the push rod. At the lower end of the push rod away from the plugging assembly, there are mark IV and mark V arranged at intervals up and down; when the upper end of the outer sheath of the push rod plugs the assembly in the initial state, the lower end of the outer sheath of the push rod is flush with mark V; after the upper end of the outer sheath of the push rod moves upward to push the plugging assembly and the movable buckle is limited in the limiting part, the lower end of the outer sheath of the push rod is flush with mark IV.

[0019] Further, the conveying assembly further includes a guide wire and a conveyor; the conveyor includes a conveyor inner core and a conveyor outer sheath sleeved inside and outside. The upper end of the conveyor inner core is a conical tip. The conveyor inner core has a through guide wire channel, and the guide wire movably penetrates through the guide wire channel; the push rod, the outer sheath of the push rod, and the plugged assembly after being folded are movably inserted into the outer sheath of the conveyor.

[0020] Further, the length of the push rod is greater than that of the outer sheath of the conveyor; at the lower end of the outer sheath of the push rod away from the plugging assembly, there are mark I, mark II, and mark III arranged at intervals up and down; when the push rod, the outer sheath of the push rod, and the plugged assembly after being folded are inserted into the outer sheath of the conveyor, when the upper end of the fixed plugging member is flush with the upper end of the outer sheath of the conveyor, the lower end of the outer sheath of the conveyor is flush with mark I; when the fixed plugging member completely extends out of the upper end of the outer sheath of the conveyor, the lower end of the outer sheath of the conveyor is flush with mark II; when the movable plugging member completely extends out of the upper end of the outer sheath of the conveyor, the lower end of the outer sheath of the conveyor is flush with mark III.

[0021] Further, the biodegradable material is small intestine collagen of sheep or pig, poly-p-dioxanone or poly-L-lactic acid.

[0022] After adopting the above technical solution, the first plugging structure and the second plugging structure located in the left and right atria are replaced from the existing mesh disk structure to a new frustum-shaped elastic ring body and elastic spines, which can reduce the volume of the plugging structure and facilitate the use and deployment of the plugging assembly; and during the deployment process, the upward movement of the elastic spines can be realized by the movement of the outer sheath of the push rod, so that the elastic spines approach the elastic ring body and finally are clamped on one side of the limiting part to realize the closure of the foramen ovale. The operation is convenient. Therefore, there is no need to use silk thread for control, and the problem of silk thread entanglement can be overcome. The setting of the limiting part ensures the tight plugging of the foramen ovale by the first plugging structure and the second plugging structure and prevents the two from detaching. Moreover, the plugging assembly is made of biodegradable material and will completely degrade and disappear after plugging the foramen ovale in the body for a period of time, so that the defect part is completely repaired and covered by its own tissue, which can reduce the risk of long-term complications. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is an exploded view of Embodiment 1 of the present invention;

[0024] Figure 2 For Figure 1 the enlarged view at position E of

[0025] Figure 3 FIG. is a partial structural schematic diagram of Embodiment 1 of the present utility model, showing the folded state;

[0026] Figure 4 FIG. is a partial structural schematic diagram of Embodiment 1 of the present utility model, showing the unfolded state;

[0027] Figure 5 FIG. is a schematic diagram of the change process of Embodiment 1 of the present utility model;

[0028] Figure 6 For Figure 4 the front view of

[0029] Figure 7 FIG. is an exploded view of the conveying assembly of Embodiment 1 of the present utility model;

[0030] Figure 8 FIG. is a partial structural schematic diagram of Embodiment 2 of the present utility model, showing the unfolded state.

[0031] Reference numeral description: Plugging assembly A, conveying assembly B, fixed plugging member 1, fixing ring 11, first plugging structure 12, movable plugging member 2, movable ring 21, second plugging structure 22, connecting rod 3, limiting portion 31, limiting step 32, pushing rod 4, pushing rod threaded portion 41, external thread 42, pushing rod outer sheath 5, pushing portion 51, guide wire 6, conveyor 7, conveyor inner core 71, conical tip portion 711, guide wire channel 712, conveyor outer sheath 72, elastic ring body c, annular self-expanding body c1, elastic rod body c2, elastic thorn body d, elastic thorn rod d1, fixed thorn d2. Detailed implementation manners

[0032] To make the objectives, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are some, but not all, of the embodiments of the present application. Usually, the components of the embodiments of the present application described and illustrated herein can be arranged and designed in various different configurations.

[0033] Embodiment 1

[0034] As Figures 1 to 7 shown, a patent foramen ovale occlusion device in this embodiment includes a plugging assembly A and a conveying assembly B. The plugging assembly A is made of a degradable material, and the degradable material can be small intestine collagen of sheep or pig, polydioxanone (PDO), poly-L-lactic acid (PLLA), etc.

[0035] Refer toFigure 2 and Figure 3 The plugging assembly A includes a fixed plugging member 1, a movable plugging member 2 and a connecting rod 3; the conveying assembly B includes a pushing rod 4 and a pushing rod sheath 5; the fixed plugging member 1 and the movable plugging member 2 are respectively arranged on the upper and lower sides of the axial direction of the connecting rod 3; a limiting portion 31 is provided at the lower end of the connecting rod 3, and the upper end of the pushing rod 4 is movably locked with the end face of the limiting portion 31 of the connecting rod 3.

[0036] The fixed plugging member 1 includes a fixed ring 11 and a first plugging structure 12, and the fixed ring 11 is fixedly connected to the upper end of the connecting rod 3; the movable plugging member 2 includes a movable ring 21 and a second plugging structure 22, and the movable ring 21 is an elastic "C"-shaped structure. The movable ring 21 moves axially along the connecting rod 3 and is finally limited to one side of the limiting portion 31 close to the fixed ring 11; specifically, the pushing rod sheath 5 is sleeved outside the pushing rod 4 and reciprocates axially along the pushing rod 4. The upper end of the pushing rod sheath 5 has a pushing portion 51, and the pushing portion 51 is used to push the movable ring 21 of the movable plugging member 2 upward. The inner diameter of the pushing portion 51 is larger than the outer diameter of the limiting portion 31, so that the movable ring 21 can be limited to one side of the limiting portion 31.

[0037] Referring to Figure 4 and the first plugging structure 12 is an elastic ring body c, and the second plugging structure 22 is an elastic thorn body d; the elastic ring body c includes an annular self-expanding body c1 and a plurality of elastic rod bodies c2. In this embodiment, four elastic rod bodies c2 are taken as an example. The annular self-expanding body c1 is connected to the fixed ring 11 through each elastic rod body c2. The elastic ring body c is compressed and closed, and automatically expands into a frustum shape when not compressed; the elastic thorn body d includes a plurality of elastic thorn rods d1. In this embodiment, six elastic thorn rods d1 are taken as an example. Each elastic thorn body d is compressed and closed, and automatically expands into a radial shape when not compressed.

[0038] Therefore, replacing the existing mesh disk structure of the first plugging structure 12 and the second plugging structure 22 located in the left and right atria with the new frustum-shaped elastic ring body c and elastic thorn body d can reduce the volume of the plugging structure, facilitate the use and deployment of the plugging assembly A; and during the deployment process, the movement of the pushing rod sheath 5 can be used to move the elastic thorn body d upward, so that the elastic thorn body d approaches the elastic ring body c and is finally clamped on one side of the limiting portion 31 to realize the closure of the patent foramen ovale, which is convenient to operate. Therefore, there is no need to use silk thread for control, and the problem of silk thread entanglement can be overcome. The setting of the limiting portion 31 ensures the tight plugging of the patent foramen ovale by the first plugging structure 12 and the second plugging structure 22 and prevents the two from detaching. Moreover, the plugging assembly A is made of a biodegradable material, and after plugging the patent foramen ovale in the body for a period of time, it will completely degrade and disappear, so that the defect site is completely repaired and covered by its own tissue, which can reduce the risk of long-term complications.

[0039] Specifically, referring toFigures 3 to 6 The annular self-expanding body c1 is coaxially arranged with the connecting rod 3, and is respectively connected to the fixing ring 11 by elastic rod bodies c2 that are circumferentially spaced apart. When the annular self-expanding body c1 is compressed and contracted, it drives each elastic rod body c2 to close and abut against the connecting rod 3. That is, the elastic rod body c2 can rotate at a certain angle relative to the fixing ring 11. For example, it can be set that the upper end of the elastic rod body c2 is hinged to the bottom surface of the fixing ring 11, and this hinge is an integral rotational connection. When the annular self-expanding body c1 is not compressed, it automatically expands and drives each elastic rod body c2 to expand away from the connecting rod 3, and the whole is in a frustum shape with the annular self-expanding body c1 facing the direction of the elastic thorn body d;

[0040] The annular self-expanding body c1 can be composed of several circumferentially distributed "W"-shaped units, and this self-expanding body can adopt the existing technical structure. The structure of the annular self-expanding body c1 in this embodiment is simple and convenient to expand, and the expanded elastic ring body c can tightly abut against the left atrial side.

[0041] On each elastic thorn rod d1 of the elastic thorn body d, several fixing thorns d2 are convexly provided. The elastic thorn rods d1 are circumferentially distributed and connected to the outer periphery of the movable ring 21. When each elastic thorn body d is compressed, it abuts against the push rod 4. Similarly, the inner end of the elastic thorn rod d1 can rotate at a certain angle relative to the movable ring 21. For example, it can be set that the inner end of the elastic thorn rod d1 is hinged to the outer wall of the movable ring 21, and this hinge is also an integral rotational connection. And the maximum angle between the axis of the elastic thorn rod d1 and the push rod 4 is set to 90 degrees. That is, when each elastic thorn body d is not compressed, it automatically expands away from the push rod 4, and the whole is in a radial shape with each fixing thorn d2 facing the direction of the elastic ring body c; when closing, the fixing thorns d2 of each elastic thorn rod d1 can be staggered from each other, and the fixing thorns d2 can be respectively attached along the tangential direction of the connecting rod 3 or the push rod 4.

[0042] In this embodiment, the elastic thorn rod d1 is provided with fixing thorns d2. After expansion, the fixing thorns d2 of the elastic thorn body d can penetrate into the atrial septal tissue around the foramen ovale, and can fix the foramen ovale tissue to prevent the foramen ovale tissue from slipping, improving the reliability of the occlusion; since the foramen ovale tissue and the surrounding atrial septal tissue are parts that need to be repaired during the occlusion process, therefore, after the occlusion component degrades and disappears, the fixing thorns also disappear, and the position where the fixing thorns are inserted and the original defect site will be completely repaired and covered by its own tissue.

[0043] Refer to Figure 2 , the top of the push rod 4 has a push rod thread part 41, and a threaded connection hole (not shown in the figure) is formed on the bottom surface of the limiting part 31 at the lower end of the connecting rod 3. The push rod thread part 41 is in threaded cooperation with this threaded connection hole. It is convenient for the push rod 4 to be separated from the occlusion component A.

[0044] The limiting part 31 has a frustum structure that is narrower at the bottom and wider at the top, and a limiting step 32 is formed on the top surface of the limiting part 31. This facilitates the upward movement of the movable ring 21. Since the movable ring 21 has an elastic "C" - shaped structure, during the upward movement along the limiting part 31, it gradually expands outward, and then automatically contracts and resets after passing over the limiting part 31, and is stuck at the limiting step 32.

[0045] Refer to Figure 1 , an axial reciprocating movement is realized between the push - rod outer sheath 5 and the push - rod 4 through screw - thread cooperation. Thus, by simple rotation, an axial displacement can occur between the push - rod outer sheath 5 and the push - rod 4, which is convenient for pushing the second plugging structure 22. Specifically, the entire inner part of the push - rod outer sheath 5 can be provided with internal threads (not shown in the figure), and external threads 42 are provided on the outer wall of the push - rod 4. Of course, partial internal threads and external threads 42 can also be set, as long as the axial displacement distance between the push - rod outer sheath 5 and the push - rod 4 meets the upward movement distance of the movable ring 21.

[0046] At the same time, for the convenience of the push - rod outer sheath 5 to push the second plugging structure 22; refer to Figure 7 , in this embodiment, the length of the push - rod 4 is greater than the length of the push - rod outer sheath 5. The lower end of the push - rod 4 far from the plugging assembly A has a mark IV and a mark V arranged at intervals up and down; when the upper end of the push - rod outer sheath 5 plugs the assembly A in the initial state, the lower end of the push - rod outer sheath 5 is flush with the mark V; after the upper end of the push - rod outer sheath 5 moves upward to push the plugging assembly A and the movable buckle is limited at the limiting part 31, the lower end of the push - rod outer sheath 5 is flush with the mark IV.

[0047] As Figure 1 and Figure 7 shown, the conveying assembly B generally further includes a guide wire 6 and a conveyor 7; the conveyor 7 includes a conveyor inner core 71 and a conveyor outer sheath 72 sleeved inside and outside. The upper end of the conveyor inner core 71 is a conical tip 711. The conveyor inner core 71 has a through - hole guide - wire channel 712, and the guide wire 6 is movably threaded through the guide - wire channel 712; the push - rod 4, the push - rod outer sheath 5, and the folded - up plugging assembly A are movably threaded through the conveyor outer sheath 72. Through the cooperation of the guide wire 6 and the conveyor inner core 71, the conveyor outer sheath 72 can be pre - sent into the foramen ovale of the atrium in the body in advance, and then the push - rod 4, the push - rod outer sheath 5, and the folded - up plugging assembly A are threaded into the conveyor outer sheath 72.

[0048] Meanwhile, for the convenience of positioning during the operation, in this embodiment, the length of the push rod 4 can be greater than the length of the outer sheath 72 of the delivery device; at the lower end of the outer sheath 5 of the push rod, which is away from the occlusion assembly A, there are Mark I, Mark II, and Mark III arranged at intervals up and down; when the push rod 4, the outer sheath 5 of the push rod, and the folded occlusion assembly A are inserted into the outer sheath 72 of the delivery device, when the upper end of the fixed occluder 1 is flush with the upper end of the outer sheath 72 of the delivery device, the lower end of the outer sheath 72 of the delivery device is flush with Mark I, when the fixed occluder 1 completely extends out of the upper end of the outer sheath 72 of the delivery device, the lower end of the outer sheath 72 of the delivery device is flush with Mark II, and when the movable occluder 2 completely extends out of the upper end of the outer sheath 72 of the delivery device, the lower end of the outer sheath 72 of the delivery device is flush with Mark III.

[0049] With the structure of this embodiment, during the operation, the following implementation method can be adopted:

[0050] Puncture the femoral vein, insert a 6F lower limb arterial sheath, and under the guidance of ultrasound or X-ray, pass the guide wire 6 through the foramen ovale and implant it into the left superior pulmonary vein. Assemble and combine the outer sheath 72 and the inner core 71 of the delivery device. After reaching the left atrium along the guide wire 6, remove the guide wire 6 and the inner core 71 of the delivery device;

[0051] Compress and fold the occlusion assembly A and connect the connecting rod 3 to the push rod 4; push the occlusion assembly A, the push rod 4, and the outer sheath 5 of the push rod together into the outer sheath 72 of the delivery device in the direction of the vein; after pushing until Mark I of the outer sheath 5 of the push rod is flush with the lower end of the outer sheath 72 of the delivery device, retract the entire delivery assembly B as a whole to clarify that the outer sheath 72 of the delivery device is in the middle of the left atrium, and then slowly push it to Mark II of the outer sheath 5 of the push rod to make the first occlusion structure 12 extend out of the upper end of the outer sheath 72 of the delivery device. The elastic ring body c of the first occlusion structure 12 can expand and release itself, forming a generally frustum-shaped whole. Retract the delivery assembly B as a whole again to make the first occlusion structure 12 close to the fossa ovalis in the left atrium;

[0052] Fix the push rod 4, push the outer sheath 72 of the delivery device outward to Mark III to make the second occlusion structure 22 extend out of the upper end of the outer sheath 72 of the delivery device. The elastic spines d of the second occlusion structure 22 can expand radially. Then rotate and push the outer sheath 5 of the push rod in the direction of the vein to expose Mark V, so that the top push part 51 pushes the movable ring 21 upward. The "C"-shaped movable ring 21 forms a clamping position after passing over the limiting part 31, and makes the second occlusion structure 22 fully expand at the right atrium, and makes the fixed spines d2 fixed to the foramen ovale tissue. Thus, the first occlusion structure 12 and the second occlusion structure 22 are combined. Gently pull and push the foramen ovale occlusion assembly A, and after confirmation of fixation, rotate and push the push rod 4 outward in the opposite direction to release the foramen ovale occlusion assembly A to complete the operation. Withdraw the outer sheath 72 of the delivery device, and compress or suture the incision.

[0053] In summary, the implementation of the entire operation process is simple and reliable, without the problem of wire entanglement, which can effectively ensure the smooth progress of the operation and the occlusion and closure of the foramen ovale.

[0054] Embodiment 2

[0055] The structure of this embodiment is basically the same as that of Embodiment 1 above. The main difference is that the first occlusion structure 12 is an elastic thorn body d, and the second occlusion structure 22 is an elastic ring body c; which is the opposite of Embodiment 1.

[0056] Correspondingly, the annular self-expanding body c1 is coaxially arranged with the connecting rod 3, and is respectively connected to the movable ring 21 by each elastic rod body c2 distributed at circumferential intervals. When the annular self-expanding body c1 is compressed and contracted, each elastic rod body c2 is closed and abuts against the pushing rod 4. When the annular self-expanding body c1 is not compressed, it automatically expands and drives each elastic rod body c2 to expand away from the pushing rod 4, and the whole is in a frustum shape with the annular self-expanding body c1 approaching the elastic thorn body d.

[0057] On each elastic thorn rod d1 of the elastic thorn body d, a number of fixing thorns d2 are convexly provided. Each elastic thorn rod d1 is circumferentially distributed and connected to the outer periphery of the fixing ring 11. When each elastic thorn body d is compressed, it abuts against the connecting rod 3. When each elastic thorn body d is not compressed, it automatically expands away from the connecting rod 3, and the whole is in a radial shape with each fixing thorn d2 facing the elastic ring body c.

[0058] Thus, the volumes of the first occlusion structure 12 and the second occlusion structure 22 can also be reduced, and a stable and reliable occlusion and closure of the foramen ovale can be ensured, and the operation is convenient.

[0059] The above are only the preferred embodiments of the present invention. The protection scope of the present invention is not limited to the above embodiments. All technical solutions falling within the idea of the present invention belong to the protection scope of the present invention. It should be pointed out that for those of ordinary skill in the art, equivalent changes and modifications made without departing from the principle of the present invention should still fall within the protection scope of the present invention.

[0060] In the description of the embodiments of the present application, it should be understood that the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of this application is usually placed during use, or the orientation or positional relationship commonly understood by those skilled in the art. It is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present application.

[0061] In addition, the terms "first", "second", "third", etc. are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of the said features. In the description of the present application, the meanings of "a plurality" and "several" are two or more, unless otherwise specifically defined.

[0062] In the description of the embodiments of the present application, it should also be noted that, unless otherwise clearly specified and limited, the terms "arranged", "installed", "connected", and "coupled" should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral connection; it may be a mechanical connection, an electrical connection, or a connection capable of mutual communication; it may be directly connected, or indirectly connected through an intermediate medium, and it may be the internal communication of two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.

[0063] In addition, the present application provides examples of various specific processes and materials, but those of ordinary skill in the art may be aware of the application of other processes and / or the use of other materials.

Claims

1. An atrial septal defect occluder device, characterized in that: It includes an occlusion component and a delivery component, and the occlusion component is made of a degradable material; The occlusion component includes a fixed occlusion piece, a movable occlusion piece and a connecting rod; the delivery component includes a push rod and a push rod outer sheath; The fixed occlusion piece and the movable occlusion piece are respectively arranged on the upper and lower sides of the axial direction of the connecting rod; a limiting part is arranged at the lower end of the connecting rod, and the upper end of the push rod is movably locked with the end face of the limiting part of the connecting rod; The fixed occlusion piece includes a fixed ring and a first occlusion structure, and the fixed ring is fixedly connected to the upper end of the connecting rod; the movable occlusion piece includes a movable ring and a second occlusion structure, and the movable ring is an elastic "C"-shaped structure, and the movable ring moves along the axial direction of the connecting rod and is finally limited to one side of the limiting part close to the fixed ring; The first occlusion structure is an elastic ring body, and the second occlusion structure is an elastic thorn body; alternatively, the first occlusion structure is an elastic thorn body, and the second occlusion structure is an elastic ring body; The elastic ring body includes an annular self-expanding body and a plurality of elastic rod bodies, and the annular self-expanding body is connected to the fixed ring or the movable ring through each elastic rod body. The elastic ring body is compressed and closed, and automatically expands into a frustum shape when not compressed; the elastic thorn body includes a plurality of elastic thorn rods, and each elastic thorn body is compressed and closed, and automatically expands into a radial shape when not compressed; The push rod outer sheath is sleeved on the push rod and reciprocates along the axial direction of the push rod. The upper end of the push rod outer sheath has a pushing part, and the pushing part is used to push the movable ring of the movable occlusion piece upward. The inner diameter of the pushing part is larger than the outer diameter of the limiting part.

2. The atrial septal defect occluder device according to claim 1, characterized in that: The annular self-expanding body is coaxially arranged with the connecting rod, and is respectively connected to the fixed ring or the movable ring through the elastic rod bodies distributed at circumferential intervals. When the annular self-expanding body is compressed and shrunk, it drives each elastic rod body to close and abut against the connecting rod or the push rod. When the annular self-expanding body is not compressed, it automatically expands and drives each elastic rod body to expand away from the connecting rod or the push rod, and the whole is in a frustum shape with the annular self-expanding body facing the direction of the elastic thorn body; A plurality of fixing thorns are convexly arranged on each elastic thorn rod of the elastic thorn body. The elastic thorn rods are circumferentially distributed and connected to the outer periphery of the movable ring or the fixed ring. When each elastic thorn body is compressed, it abuts against the connecting rod or the push rod. When each elastic thorn body is not compressed, it automatically expands away from the connecting rod or the push rod, and the whole is in a radial shape with each fixing thorn facing the direction of the elastic ring body.

3. The patent foramen ovale occlusion device according to claim 1 or 2, characterized in that: The annular self-expanding body is composed of a plurality of circumferentially distributed "W"-shaped units.

4. The patent foramen ovale occlusion device according to claim 1, characterized in that: The top of the push rod has a push rod thread part, and a threaded connection hole is formed on the bottom surface of the limiting part at the lower end of the connecting rod. The push rod thread part is in threaded cooperation with the threaded connection hole.

5. The patent foramen ovale occlusion device according to claim 1, characterized in that: The limiting part is a frustum structure with a narrow bottom and a wide top, and a limiting step is formed on the top surface of the limiting part.

6. The patent foramen ovale occlusion device according to claim 1, wherein: The push rod outer sheath and the push rod achieve axial reciprocating movement through threaded cooperation.

7. The patent foramen ovale occlusion device according to claim 1, characterized in that: The length of the push rod is greater than the length of the outer sheath of the push rod. At the lower end of the push rod away from the plugging assembly, there are mark IV and mark V arranged at intervals up and down. When the upper end of the outer sheath of the push rod plugs the assembly in the initial state, the lower end of the outer sheath of the push rod is flush with mark V. After the upper end of the outer sheath of the push rod moves upward to push the plugging assembly and the movable buckle is limited in the limiting part, the lower end of the outer sheath of the push rod is flush with mark IV.

8. The patent foramen ovale occlusion device according to claim 1, characterized in that: The conveying assembly further includes a guide wire and a conveyor. The conveyor includes a conveyor inner core and a conveyor outer sheath sleeved inside and outside. The upper end of the conveyor inner core is a conical tip part. The conveyor inner core has a through guide wire channel, and the guide wire movably penetrates through the guide wire channel. The push rod, the outer sheath of the push rod and the folded plugging assembly are movably arranged inside the outer sheath of the conveyor.

9. The patent foramen ovale occlusion device according to claim 8, characterized in that: The length of the push rod is greater than the length of the outer sheath of the conveyor. At the lower end of the outer sheath of the push rod away from the plugging assembly, there are mark I, mark II and mark III arranged at intervals up and down. When the push rod, the outer sheath of the push rod and the folded plugging assembly are arranged inside the outer sheath of the conveyor, when the upper end of the fixed plugging piece is flush with the upper end of the outer sheath of the conveyor, the lower end of the outer sheath of the conveyor is flush with mark I. When the fixed plugging piece completely extends out of the upper end of the outer sheath of the conveyor, the lower end of the outer sheath of the conveyor is flush with mark II. When the movable plugging piece completely extends out of the upper end of the outer sheath of the conveyor, the lower end of the outer sheath of the conveyor is flush with mark III.

10. The patent foramen ovale occlusion device according to claim 1, wherein: The degradable material is small intestine collagen of sheep or pig, poly-p-dioxanone or poly-L-lactic acid.

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