Plugging device

Abstract

The invention belongs to the technical field of medical instruments, and discloses a plugging device which comprises a near-end supporting mechanism, a near-end supporting mechanism, a near-end choked flow membrane, a far-end supporting mechanism, a far-end choked flow membrane and a suture line. In the first projection plane, the second part of the near-end supporting mechanism and the second part of the far-end supporting mechanism both bend and extend in the direction away from the first part, and in the second projection plane, the second part of the near-end supporting mechanism and the second part of the far-end supporting mechanism both incline towards the sides close to each other. The first projection surface is perpendicular to the second projection surface. When the plugging device is used, the near-end choked flow film and the far-end choked flow film play a good role in wrapping the oval hole, the effect of plugging the oval hole is achieved, the second portion of the near-end supporting mechanism and the second portion of the far-end supporting mechanism cannot directly face the side face of the atrial septum, the effect of protecting the atrial septum is achieved, and the plugging device is simple in structure and convenient to use. And the possibility that the atrial septum is damaged in the plugging process is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a occluder. Background Art

[0002] The foramen ovale is a passage between the left and right ventricles during the fetal period. The umbilical vein blood from the mother enters the left heart cavity of the fetus through this passage, and then flows to the whole body to provide the oxygen and nutrients required for fetal development. Without the foramen ovale, the fetus cannot develop normally. Therefore, the foramen ovale is a necessary and normal physiological structure. After the child is born and can establish a normal pulmonary circulation on its own, the mission of the foramen ovale is completed. With the first cry, the pressure in the left atrium increases, causing the oval fossa valve part of the primary septum in the left heart cavity to closely adhere to the edge of the oval fossa of the secondary septum on the right side, achieving functional closure. And the anatomical complete closure generally occurs 5-7 months after birth. About 77.6% of newborn babies' foramen ovale will close within 1 year. There are also people whose foramen ovale has never closed. If the foramen ovale has not closed normally after the age of 3, it is considered a true patent foramen ovale.

[0003] In most people, the pressure in the left atrium is greater than that in the right atrium. Therefore, even if there is a patent foramen ovale, the shunt from the left to the right through the foramen ovale is very small and will not cause obvious symptoms. The blood flow from the foramen ovale to the left atrium and then to the whole body during the fetal period is for the normal development of the fetus, while such blood flow after birth may cause some problems. "Atrial septal defect" is similar to patent foramen ovale, but "atrial septal defect" is a congenital heart malformation. Atrial septal defect is caused by abnormalities during embryonic development and usually has symptoms such as shortness of breath, palpitations, and fatigue. Patent foramen ovale and atrial septal defect are cases where there is a residual unclosed atrial opening between the left and right atria, and blood may flow between the two atria. However, the size of the hole in patent foramen ovale is generally smaller than that in atrial septal defect (about 4 mm for the foramen ovale and about 8 mm for the atrial septal defect), and the valve defect hole will not extend vertically to the valve wall, that is, the left atrial valve defect hole and the right atrial valve defect hole are not concentric. If the diameter of the patent foramen ovale reaches more than 4 mm, it will cause relatively great harm to the body.

[0004] In the prior art, placing a occluding device can effectively prevent thrombus from flowing into the left atrium. Atrial septal defect is divided into two types: secundum defect and primum defect. The defect is relatively large and generally needs to be repaired. Currently, there are various types of intracardiac occluding devices for treating congenital heart diseases, and these occluding devices are sent to specific positions in the patient's heart through a catheter or a wire.

[0005] Most of the occluders on the current market are disc-shaped. When performing occlusion, the tip of the occluder will directly abut against the side of the atrial septum. Although a spherical structure can be provided at the tip to reduce the sharpness of the tip, during occlusion, the occluder needs to maintain a certain extrusion force with the atrial septum to prevent the occluder from shifting or even tipping over, resulting in the tip still being prone to causing trauma to the atrial septum. Summary of the Invention

[0006] The purpose of the present invention is to provide an occluder, which solves the problem that the tip of the occluder in the prior art needs to abut tightly against the atrial septum during use, which is prone to causing trauma to the atrial septum.

[0007] To achieve this purpose, the present invention adopts the following technical solutions:

[0008] An occluder, which includes:

[0009] A proximal support mechanism;

[0010] A distal support mechanism, which is disposed opposite to the proximal support mechanism;

[0011] A proximal flow-blocking membrane, the proximal flow-blocking membrane at least covers the side of the proximal support mechanism facing away from the distal support mechanism;

[0012] A distal flow-blocking membrane, the distal flow-blocking membrane at least covers the side of the distal support mechanism facing away from the proximal support mechanism; and

[0013] A first suture, which is threaded through the proximal support mechanism and connected to the distal support mechanism;

[0014] Wherein, in the first projection plane, the second part of the proximal support mechanism and the second part of the distal support mechanism both bend and extend in a direction away from the first part, and in the second projection plane, the second part of the proximal support mechanism and the second part of the distal support mechanism both incline towards the side close to each other, and the first projection plane is perpendicular to the second projection plane.

[0015] Optionally, the occluder further includes an elastic connecting member, and the elastic connecting member includes:

[0016] A connecting spring, the proximal end of the connecting spring has a proximal connecting ball, the proximal connecting ball is fixedly connected to the proximal support mechanism, the distal end of the connecting spring has a distal connecting ball, and the distal connecting ball is fixedly connected to the distal support mechanism.

[0017] Optionally, the proximal support mechanism includes:

[0018] A proximal skeleton, the second part of the proximal skeleton is fixedly connected to the proximal flow-blocking membrane; and

[0019] The proximal buckle is clamped to the first part of the proximal skeleton and fixes the proximal flow-blocking film at the first part of the proximal skeleton so that the proximal flow-blocking film covers at least one side of the proximal skeleton;

[0020] Wherein, in the first projection plane, the second part of the proximal skeleton bends and extends in a direction away from the first part, and in the second projection plane, the second part of the proximal skeleton inclines towards the side close to the distal support mechanism, and the included angle between the inclination direction and the first projection plane is an acute angle; and / or

[0021] The distal support mechanism includes:

[0022] A distal skeleton, the second part of the distal skeleton is fixedly connected to the distal flow-blocking film; and

[0023] A distal buckle, which is clamped to the first part of the distal skeleton and fixes the distal flow-blocking film at the first part of the distal skeleton so that the distal flow-blocking film covers at least one side of the distal skeleton;

[0024] Wherein, in the first projection plane, the second part of the distal skeleton bends and extends in a direction away from the first part of the distal skeleton, and in the second projection plane, the second part of the distal skeleton inclines towards the side close to the proximal support mechanism, and the included angle between the inclination direction and the first projection plane is an acute angle.

[0025] Optionally, the proximal skeleton includes a proximal support ring and at least two proximal support rods, the proximal support rods are distributed around the proximal support ring, and one end of the proximal support rod is connected to the proximal support ring;

[0026] In the first projection plane, the proximal support rod bends and extends, and in the second projection plane, the end of the proximal support rod far from the proximal support ring inclines towards the side close to the distal support mechanism, and the included angle between the inclination direction and the first projection plane is an acute angle;

[0027] and / or:

[0028] The distal skeleton includes a distal support ring and at least two distal support rods, the distal support rods are distributed around the distal support ring, and one end of the distal support rod is connected to the distal support ring. In the first projection plane, the distal support rod bends and extends, and in the second projection plane, the end of the distal support rod far from the distal support ring inclines towards the side close to the proximal support mechanism, and the included angle between the inclination direction and the first projection plane is an acute angle.

[0029] Optionally, the first projection plane is parallel to the ring plane of the proximal support ring, and the second projection plane is perpendicular to the ring plane of the proximal support ring.

[0030] Optionally, the proximal skeleton further includes a proximal ring disposed on a side of the proximal support rod away from the proximal support ring; and / or

[0031] The distal skeleton further includes a distal ring disposed at an end of the distal support rod away from the distal support ring.

[0032] Optionally, the proximal buckle includes:

[0033] A proximal snap ring that abuts against the proximal skeleton and presses the proximal flow-blocking membrane against a first portion of the proximal skeleton; and

[0034] A proximal snap rod, one end of the proximal snap rod is connected to the proximal snap ring, and the other end of the proximal snap rod passes through the proximal skeleton and is fixedly clamped with the proximal skeleton; and / or

[0035] The distal buckle includes:

[0036] A distal snap ring that abuts against the distal support ring and presses the distal flow-blocking membrane against the distal support ring; and

[0037] A distal snap rod, one end of the distal snap rod is connected to the distal snap ring, and the end of the distal snap rod away from the distal snap ring passes through the distal support ring and is fixedly clamped with the distal support ring.

[0038] Optionally, the proximal skeleton is made of a nitinol alloy material by laser cutting and then heat setting or by a weaving process; and / or

[0039] The proximal buckle is made of a medical stainless steel material; and / or

[0040] The distal skeleton is made of a nitinol alloy material by laser cutting and then heat setting or by a weaving process; and / or

[0041] The distal buckle is made of a medical stainless steel material.

[0042] Optionally, the distal snap ring abuts against a side of the distal support ring close to the proximal support mechanism, and the distal snap ring has a notch corresponding to the distal support rod.

[0043] Optionally, the inner wall of the distal snap ring is provided with a thread for threaded connection with a delivery system.

[0044] Advantages of the present invention:

[0045] When occluding the patent foramen ovale, the occluder is passed through the patent foramen ovale by using a delivery system, and the distal support mechanism provided with a distal blocking membrane is released on the side of the atrial septum close to the left atrium, and the distal support mechanism is adjusted so that the second part of the distal support mechanism abuts against the side of the atrial septum close to the left atrium. Then, the proximal support mechanism provided with a proximal blocking membrane is released on the side of the atrial septum close to the right atrium by using the delivery system. When the proximal support mechanism is detached from the delivery system, the second part of the proximal support mechanism can tightly abut against the side of the atrial septum close to the right atrium. After the proximal support mechanism tightly abuts against the side of the atrial septum close to the right atrium, the first suture is operated to be further tightened and sutured, so as to use the proximal blocking membrane wrapped around the proximal support mechanism and the distal blocking membrane wrapped around the distal support mechanism to play a better wrapping role on the patent foramen ovale, achieving the effect of occluding the patent foramen ovale, and thus successfully completing the occlusion. In this way, when the occluder is in use, the second part of the proximal support mechanism and the second part of the distal support mechanism will respectively tightly abut against both sides of the atrial septum, so as to respectively attach the proximal blocking membrane and the distal blocking membrane to both ends of the patent foramen ovale, so as to play a better wrapping property on the patent foramen ovale, achieving the effect of occluding the patent foramen ovale. And both second parts are bent and extended in a direction away from the first part in the first projection plane, and then are inclined towards the side close to each other in the second projection plane, and the projections of the proximal support mechanism and the distal support mechanism in the second projection plane are triangles with one side parallel or coincident, so that the second part of the proximal support mechanism and the second part of the distal support mechanism are not directly opposite to the side surface of the atrial septum, so that when tightly abutting against the side surface of the atrial septum, the contact area between the two can be effectively increased, playing a protective effect on the atrial septum and reducing the possibility of damage to the atrial septum during the occlusion process. Description of the Drawings

[0046] Figure 1 is a schematic structural diagram of the occluder in an embodiment of the present invention;

[0047] Figure 2 is a schematic structural diagram of the first suture of the occluder in an embodiment of the present invention;

[0048] Figure 3 is a side view of the structure of the occluder in an embodiment of the present invention;

[0049] Figure 4 is a schematic structural diagram of the proximal framework of the occluder in an embodiment of the present invention;

[0050] Figure 5 is a schematic structural diagram of the proximal buckle of the occluder in an embodiment of the present invention;

[0051] Figure 6 is a schematic structural diagram of the distal framework of the occluder in an embodiment of the present invention;

[0052] Figure 7It is a schematic structural diagram of the distal buckle of the occluder in the embodiment of the present invention;

[0053] Figure 8 It is a schematic structural diagram of the elastic connecting member of the occluder in the embodiment of the present invention.

[0054] In the figure:

[0055] 1. Elastic connecting member; 11. Connecting spring; 12. Proximal connecting ball; 13. Distal connecting ball;

[0056] 2. Proximal support mechanism; 21. Proximal skeleton; 211. Proximal support ring; 212. Proximal support rod; 213. Proximal wire hole; 214. Proximal connection hole; 215. Proximal ring; 22. Proximal buckle; 221. Proximal snap ring; 222. Proximal snap rod;

[0057] 3. Distal support mechanism; 31. Distal skeleton; 311. Distal support ring; 312. Distal support rod; 313. Distal wire hole; 315. Distal ring; 32. Distal buckle; 321. Distal snap ring; 322. Distal snap rod; 323. Notch; 324. Distal connection hole; 325. Through hole;

[0058] 4. First suture. Detailed implementation manners

[0059] The present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It can be understood that the specific embodiments described herein are only used to explain the present invention, rather than limiting the present invention. Additionally, it should be noted that for the convenience of description, only the parts related to the present invention are shown in the drawings, rather than all the structures.

[0060] In the description of the present invention, unless otherwise clearly defined and limited, the terms "connected", "connected to", and "fixed" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication of two components or the interaction relationship between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0061] In the present invention, unless otherwise clearly specified or limited, the first feature being "above" or "below" the second feature may include the direct contact between the first and second features, or may include the situation where the first and second features are not in direct contact but in contact through additional features therebetween. Moreover, the first feature being "above", "over" and "on top of" the second feature includes that the first feature is directly above and obliquely above the second feature, or merely indicates that the horizontal height of the first feature is higher than that of the second feature. The first feature being "below", "beneath" and "underneath" the second feature includes that the first feature is directly below and obliquely below the second feature, or merely indicates that the horizontal height of the first feature is lower than that of the second feature.

[0062] In the description of this embodiment, the orientation or positional relationships such as "above", "below", "left" and "right" are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of description and simplifying the operation, 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 thus should not be construed as a limitation to the present invention. In addition, the terms "first" and "second" are only used for distinction in description and have no special meaning.

[0063] An embodiment of the present invention discloses a occluder.

[0064] Refer to Figures 1 to 3 , the occluder includes a proximal support mechanism 2, a proximal flow-blocking membrane, a distal support mechanism 3, a distal flow-blocking membrane and a first suture 4. The distal support mechanism 3 is disposed opposite to the proximal support mechanism 2; the proximal flow-blocking membrane at least covers the side of the proximal support mechanism 2 facing away from the distal support mechanism 3; the distal flow-blocking membrane at least covers the side of the distal support mechanism 3 facing away from the proximal support mechanism 2; the first suture 4 passes through the proximal support mechanism 2 and is connected to the distal support mechanism 3. Wherein, in a first projection plane, the second part of the proximal support mechanism 2 and the second part of the distal support mechanism 3 both bend and extend in a direction away from the first part, and in a second projection plane, the second part of the proximal support mechanism 2 and the second part of the distal support mechanism 3 both incline towards the side close to each other, and the first projection plane is perpendicular to the second projection plane.

[0065] Specifically, the first part of the proximal support mechanism 2 is fixed to the proximal flow-blocking membrane by a clamping method, and the second part is fixed to the proximal flow-blocking membrane by a second suture, so that the proximal flow-blocking membrane and the proximal support mechanism 2 form a covering relationship. Similarly, the distal flow-blocking membrane is fixed to the distal support mechanism 3 in the same way, so that the distal flow-blocking membrane and the distal support mechanism 3 form a covering relationship.

[0066] Taking the deformation direction of the elastic connecting member 1 as a reference, the first projection plane is a plane perpendicular to the above-mentioned deformation direction, and the second projection plane is a plane parallel to the above-mentioned deformation direction. The second part bends and extends away from the first part in the first projection plane, so that the second part is not directly facing the interatrial septum. The two second parts incline towards the side close to each other in the second projection plane, and the projections of the proximal support mechanism 2 and the distal support mechanism 3 in the second projection plane form a triangle with one side parallel or coincident, so that the proximal support mechanism 2 and the distal support mechanism 3 as a whole can form an opposing bell mouth shape to respectively abut against both sides of the interatrial septum during occlusion. The first suture 4 can be made of medical polymer materials, such as PP (polypropylene), PET (polyethylene terephthalate), or nylon, etc.

[0067] When occluding the patent foramen ovale, the occluder is passed through the patent foramen ovale by using a delivery system, and the distal support mechanism 3 provided with the distal blocking membrane is released on the side of the interatrial septum close to the left atrium, and the distal support mechanism 3 is adjusted so that the second part of the distal support mechanism 3 abuts against the side of the interatrial septum close to the left atrium. Then, the proximal support mechanism 2 provided with the proximal blocking membrane is released on the side of the interatrial septum close to the right atrium by using the delivery system. After the proximal support mechanism 2 is detached from the delivery system, the second part of the proximal support mechanism 2 can abut tightly against the side of the interatrial septum close to the right atrium. After the proximal support mechanism 2 abuts tightly against the side of the interatrial septum close to the right atrium, the first suture 4 is operated to be further tightened and sutured, so as to use the proximal blocking membrane wrapped around the proximal support mechanism 2 and the distal blocking membrane wrapped around the distal support mechanism 3 to play a better wrapping role on the patent foramen ovale, achieving the effect of occluding the patent foramen ovale, and thus successfully completing the occlusion.

[0068] In this way, when the occluder is in use, the second parts of the proximal support mechanism 2 and the distal support mechanism 3 will respectively abut tightly against both sides of the interatrial septum. The two second parts both bend and extend away from the first part in the first projection plane, and then incline towards the side close to each other in the second projection plane. The projections of the proximal support mechanism 2 and the distal support mechanism 3 in the second projection plane form a triangle with one side parallel or coincident, so that the second parts of the proximal support mechanism 2 and the distal support mechanism 3 are not directly facing the side of the interatrial septum, so that the contact area between the two can be effectively increased when abutting against the side of the interatrial septum, playing a protective role on the interatrial septum and reducing the possibility of damage to the interatrial septum during the occlusion process.

[0069] Optionally, the occluder further includes an elastic connecting member 1. The proximal support mechanism 2 is disposed at one end of the elastic connecting member 1, and the distal support mechanism 3 is disposed at the other end of the elastic connecting member 1. Specifically, the elastic connecting member 1 is strip-shaped, and its two ends are respectively fixedly connected to the proximal support mechanism 2 and the distal support mechanism 3. The fixing method can be welding to ensure the stability of the connection.

[0070] With the arrangement of the elastic connecting member 1, when the distal support mechanism 3 abuts against the side of the atrial septum close to the left atrium, during the process of releasing the proximal support mechanism 2, the elastic connecting member 1 is in a stretched state to pull the proximal support mechanism 2 away from the delivery system. When the second part of the proximal support mechanism 2 abuts against the side of the atrial septum close to the right atrium, the elastic connecting member 1 will return to its natural state or maintain a certain degree of stretching state to position and pre-tighten the proximal support mechanism 2, effectively reducing the possibility of the occluder flipping.

[0071] Refer to Figure 3 , optionally, the proximal support mechanism 2 includes a proximal skeleton 21 and a proximal buckle 22. The second part of the proximal skeleton 21 is fixedly connected to the proximal flow-blocking membrane; the proximal buckle 22 is clamped to the first part of the proximal skeleton 21 and fixes the proximal flow-blocking membrane to the first part of the proximal skeleton 21 so that the proximal flow-blocking membrane covers the side of the proximal skeleton 21 facing away from the distal support mechanism 3. Among them, in the first projection plane, the second part of the proximal skeleton 21 extends bent in a direction away from the first part, and in the second projection plane, the second part of the proximal skeleton 21 inclines towards the side close to the distal support mechanism 3, and the included angle between the inclination direction and the first projection plane is an acute angle.

[0072] Specifically, the central part of the proximal skeleton 21 is annular to form the above-mentioned first part, and the first part is clamped with the proximal buckle 22 to press and fix the proximal flow-blocking membrane at the first part. In the first projection plane, the second part of each rod-shaped structure extends bent in a direction away from the first part, and in the second projection plane, the second part of each rod-shaped structure inclines towards the side close to the distal support mechanism 3, and the inclination direction forms a certain included angle with the first projection plane.

[0073] By setting the proximal skeleton 21 and the proximal buckle 22, the proximal flow-blocking membrane can be fixed at the first part of the proximal skeleton 21 by clamping, and the proximal flow-blocking membrane can be fixed at the second part of the proximal skeleton 21 by the second suture. This can not only effectively fix the proximal flow-blocking membrane through a simple structure, but also enable the second part of the proximal skeleton 21 to smoothly abut against the right side of the atrial septum during occlusion, and also make the structure of the proximal support mechanism 2 simple and reliable, effectively reducing the number of structures that need to be implanted into the body during occlusion.

[0074] Refer to Figure 4, optionally, the proximal skeleton 21 includes a proximal support ring 211. At least two proximal support rods 212 are distributed around the proximal support ring 211. In the first projection plane, the proximal support rods 212 bend and extend. In the second projection plane, one end of the proximal support rod 212 away from the proximal support ring 211 inclines towards the side close to the distal support mechanism 3, and the included angle between the inclination direction and the first projection plane is an acute angle.

[0075] Specifically, the proximal support ring 211 is circular and serves as the first part of the proximal support mechanism 2. Two proximal wire holes 213 are formed through the side wall of the proximal support ring 211, and the two proximal wire holes 213 are arranged oppositely. The first suture 4 can pass through the proximal wire holes 213. At a position 90° away from the proximal wire holes 213, proximal connection holes 214 with apertures smaller than those of the proximal wire holes 213 are formed. The proximal connection holes 214 are fixedly connected to the elastic connecting piece 1 by argon arc welding. The above-mentioned proximal support rods 212 are arranged on the side of the proximal support ring 211 close to the distal support mechanism 3. The proximal support rods 212 are strip-shaped, and one end of the proximal support rod 212 away from the proximal support ring 211 serves as the second part of the proximal support mechanism 2. The bending amplitudes of at least two proximal support rods 212 are the same and are equally spaced. At the same time, the distance between the proximal support rods 212 and the distal support mechanism 3 decreases from the end close to the proximal support ring 211 to the side away from the proximal support ring 211. In this embodiment, 6 proximal support rods 212 are distributed at intervals. At this time, the proximal support mechanism 2 has 6 second parts, and the 6 second parts can be distributed in a hexagonal shape. The present invention does not limit the number of proximal support rods 212. The more the number of proximal support rods 212, the closer the distribution shape of the multiple second parts of the proximal support mechanism 2 is to a circle.

[0076] By setting the proximal support ring 211 as the first part of the proximal support mechanism 2 and arranging a plurality of proximal support rods 212 around the proximal support ring 211, and the proximal support rods 212 bend and extend and are inclined, a proximal skeleton 21 with a strength meeting the requirements is formed. At the same time, it can also ensure that the second part of the proximal support rod 212 away from the proximal support ring 211 does not face the atrial septum directly, so as to ensure that the proximal support rod 212 can smoothly play a protective role when abutting against the atrial septum.

[0077] Optionally, the proximal skeleton 21 further includes a proximal circular ring 215. The proximal circular ring 215 is arranged on the side of the proximal support rod 212 away from the proximal support ring 211, and the side surface of the proximal circular ring 215 is used to fit with the atrial septum.

[0078] Specifically, the proximal ring 215 is annular, its outer diameter is greater than the width of the proximal support rod 212, and the thickness of the proximal ring 215 can be equal to the thickness of the proximal support rod 212, so as to increase the contact area between the proximal support rod 212 and the atrial septum, and at the same time reduce the sharpness of the second part of the proximal support rod 212, further improving the protection effect on the atrial septum. Moreover, the inside of the proximal ring 215 is hollow, which can also provide space for subsequent puncture of the atrial septum to facilitate the puncture operation on the atrial septum here.

[0079] Referring to Figure 5 , optionally, the proximal buckle 22 includes a proximal clamping ring 221 and a proximal clamping rod 222. The proximal clamping ring 221 abuts against the proximal skeleton 21 and presses the proximal flow-blocking membrane against the first part of the proximal skeleton 21; the proximal clamping rod 222 is arranged on the proximal clamping ring 221, and the end of the proximal clamping rod 222 away from the proximal clamping ring 221 passes through the proximal skeleton 21 and is fixedly clamped with the proximal skeleton 21.

[0080] Specifically, the outer diameter of the proximal clamping ring 221 is greater than the inner diameter of the proximal support ring 211, so that the end face of the proximal clamping ring 221 can form a clamping connection with the end face of the proximal support ring 211. The proximal clamping rod 222 is arranged on the inner side of the proximal clamping ring 221, and the proximal clamping rod 222 extends along the height direction of the proximal clamping ring 221, and its length is greater than the height of the proximal support ring 211. A clamping foot is arranged on the side of the proximal clamping rod 222 away from the proximal clamping ring 221, and at least two proximal clamping rods 222 can be distributed at intervals. In this embodiment, two proximal clamping rods 222 are arranged opposite to each other.

[0081] When pressing the flow-blocking membrane, first pass the proximal clamping rod 222 through the proximal support ring 211, and use the clamping foot of the proximal clamping rod 222 to abut against the side of the proximal support ring 211 close to the distal support mechanism 3, while the proximal clamping ring 221 abuts against the other side of the proximal support ring 211, and the proximal flow-blocking membrane is clamped between the proximal clamping ring 221 and the proximal support ring 211. In this way, the structure of the proximal buckle 22 is simple, and the proximal flow-blocking membrane can be stably fixed and pressed.

[0082] Referring to Figure 3 , optionally, the distal support mechanism 3 includes a distal skeleton 31 and a distal buckle 32. The second part of the distal skeleton 31 is fixedly connected to the distal flow-blocking membrane; the distal buckle 32 is clamped to the first part of the distal skeleton 31 and fixes the distal flow-blocking membrane to the first part of the distal skeleton 31 so that the distal flow-blocking membrane covers the side of the distal skeleton 31 facing away from the proximal support mechanism 2. Among them, in the first projection plane, the second part of the distal skeleton 31 bends and extends in the direction away from the first part, and in the second projection plane, the second part of the distal skeleton 31 inclines towards the side close to the proximal support mechanism 2, and the included angle between the inclination direction and the first projection plane is an acute angle.

[0083] Specifically, the central part of the distal skeleton 31 is annular to form the above-mentioned first part, and the first part is clamped with the distal buckle 32 to press and fix the distal flow-blocking membrane on the first part. In the first projection plane, the second part of each rod-shaped structure bends and extends along the direction away from the first part. In the second projection plane, the second part of each rod-shaped structure inclines towards the side close to the proximal support mechanism 2, and the inclination direction forms a certain angle with the first projection plane.

[0084] By providing the distal skeleton 31 and the distal buckle 32, the distal flow-blocking membrane can be fixed at the first part of the distal skeleton 31 by clamping, and the distal flow-blocking membrane can be fixed at the second part of the distal skeleton 31 by the first suture 4. This can not only effectively fix the distal flow-blocking membrane, but also enable the second part of the distal skeleton 31 to smoothly abut against the other side of the atrial septum during occlusion. Moreover, it makes the structure of the distal support mechanism 3 simple and reliable, effectively reducing the number of structures that need to be implanted into the body during occlusion.

[0085] Referring to Figure 6 , optionally, the distal skeleton 31 includes a distal support ring 311. At least two distal support rods 312 are distributed annularly around the distal support ring 311. In the first projection plane, the distal support rods 312 bend and extend. In the second projection plane, the end of the distal support rod 312 away from the distal support ring 311 inclines towards the side close to the proximal support mechanism 2, and the angle between the inclination direction and the first projection plane is an acute angle.

[0086] Specifically, the distal support ring 311 is circular as the first part of the distal support mechanism 3, and two distal wire holes 313 are formed through its side wall. The two distal wire holes 313 are arranged oppositely, and the first suture 4 can pass through the distal wire holes 313 to realize the connection between the distal skeleton 31 and the proximal skeleton 21. The above-mentioned distal support rods 312 are arranged on the side of the distal support ring 311 close to the proximal support mechanism 2. The distal support rods 312 are strip-shaped, and the end away from the distal support ring 311 is the second part of the distal support mechanism 3. The bending amplitudes of at least two distal support rods 312 are the same and are equally spaced. At the same time, the distance between the distal support rods 312 and the proximal support mechanism 2 decreases from the end close to the distal support ring 311 to the side away from the distal support ring 311. In this embodiment, the distal support rods 312 and the proximal support rods 212 maintain a one-to-one correspondence relationship, so that the corresponding proximal support rods 212 and distal support rods 312 can symmetrically abut on both sides of the atrial septum.

[0087] By setting the distal support ring 311 as the first part of the distal support mechanism 3, and arranging a plurality of distal support rods 312 annularly distributed on the distal support ring 311, and the distal support rods 312 are bent and extended and inclined, so as to form a distal skeleton 31 with a strength meeting the requirements, and at the same time, it can also ensure that the second part of the distal support rod 312 away from the distal support ring 311 does not face the atrial septum, so as to ensure that the distal support rod 312 can smoothly play a protective effect when abutting against the atrial septum.

[0088] Optionally, the distal skeleton 31 further includes a distal ring 315. The distal ring 315 is arranged on the side of the distal support rod 312 away from the distal support ring 311, and the side surface of the distal ring 315 is used for fitting with the atrial septum.

[0089] Specifically, the distal ring 315 is annular, its outer diameter is larger than the width of the distal support rod 312, and the thickness of the distal ring 315 can be equal to the thickness of the distal support rod 312, so as to increase the contact area between the distal support rod 312 and the atrial septum, and at the same time, it can also reduce the sharpness of the second part of the distal support rod 312, further improving the protective effect on the atrial septum. Moreover, the inside of the distal ring 315 is hollow, which can also provide space for subsequent puncture of the atrial septum to facilitate the puncture operation on the atrial septum here.

[0090] Refer to Figure 7 , optionally, the distal buckle 32 includes a distal snap ring 321 and a distal snap rod 322. The distal snap ring 321 abuts against the distal support ring 311 and presses the distal flow blocking membrane on the distal support ring 311; the distal snap rod 322 is arranged on the distal snap ring 321, and one end of the distal snap rod 322 away from the distal snap ring 321 passes through the distal support ring 311 and is fixedly clamped with the distal support ring 311.

[0091] Specifically, the outer diameter of the distal snap ring 321 is larger than the inner diameter of the distal support ring 311, so that the end surface of the distal snap ring 321 can form a clamping connection with the end surface of the distal support ring 311. A distal connection hole 324 is opened in the distal snap ring 321, and the distal connection hole 324 is fixedly connected with the elastic connecting piece 1 by argon arc welding. The distal snap rod 322 is arranged on the inner side of the distal snap ring 321, the distal snap rod 322 extends along the height direction of the distal snap ring 321, its length is greater than the height of the distal support ring 311, a clamping foot is arranged on the side of the distal snap rod 322 away from the distal snap ring 321, and a plurality of distal snap rods 322 can be distributed at intervals. In this embodiment, two distal snap rods 322 are arranged oppositely.

[0092] When pressing the flow-blocking film, first pass the distal clamping rod 322 through the distal support ring 311. Use the clamping feet of the distal clamping rod 322 to abut against the side of the distal support ring 311 away from the proximal support mechanism 2, while the distal clamping ring 321 abuts against the other side of the distal support ring 311. The distal flow-blocking film is clamped between the distal clamping ring 321 and the distal support ring 311. This makes the structure of the distal buckle 32 simple and can also stably fix and press the distal flow-blocking film.

[0093] Optionally, the distal clamping ring 321 abuts against the side of the distal support ring 311 close to the proximal support mechanism 2, and the distal clamping ring 321 has a notch 323 corresponding to the distal support rod 312.

[0094] Specifically, the distal support rod 312 extends from the side of the distal support ring 311 close to the proximal support mechanism 2, and the distal clamping ring 321 also abuts against this side of the distal support ring 311, that is, the distal clamping ring 321 is inserted into the distal support ring 311 from the side close to the proximal support mechanism 2 to form a clamping connection. At this time, when the distal flow-blocking film is fixed on the distal support mechanism 3, it will completely cover the distal clamping ring 321. In order to avoid interference between the distal support rod 312 and the distal clamping ring 321, the above-mentioned notch 323 is opened on the peripheral wall of the distal clamping ring 321, and the distal support rod 312 passes through the notch 323. The number of notches 323 corresponds to the number of distal support rods 312.

[0095] Through the setting of the notch 323, not only is the interference between the distal support rod 312 and the distal clamping ring 321 effectively avoided, but also since the distal support rod 312 is fixed on the distal support ring 311, the cooperation between the distal support rod 312 and the notch 323 can also limit the position of the distal clamping ring 321, avoiding displacements such as rotation of the distal clamping ring 321, and further improving the connection stability between the distal buckle 32 and the distal skeleton 31. It should be understood that the distal buckle 32 may not be provided with the notch 323, and it can also form a clamping connection when inserted into the distal support ring 311 from the side away from the proximal support mechanism 2. At this time, when the distal flow-blocking film is fixed on the distal support mechanism 3, it will not completely cover the distal buckle 32, and the distal buckle 32 and the proximal buckle 22 are symmetrically distributed. The specific setting method of the distal resistance film can be designed according to actual application requirements.

[0096] Optionally, the inner wall of the distal clamping ring 321 is provided with threads for threaded connection with the conveying system.

[0097] Specifically, a through hole 325 is formed through the middle of the distal retaining ring 321. The aperture of the through hole 325 can be 0.5 mm, and the inner wall of the hole is provided with internal threads. During transportation, it is first threadedly connected to the transportation system so that the transportation system can drive the distal support mechanism 3 through the oval foramen. After releasing the distal support mechanism 3, the transportation system can be separated from the distal retaining ring 321 by screwing, so as to smoothly separate the distal support mechanism 3 from the transportation system after adjusting the distal support mechanism 3.

[0098] Optionally, the proximal frame 21 and the distal frame 31 are made of nitinol alloy material by laser cutting and then heat setting or by a braiding process. The proximal buckle 22 and the distal buckle 32 are made of medical stainless steel material.

[0099] Specifically, in the prior art, there are biodegradable occluders. After implanting the biodegradable occluder, the collagen membrane of the biodegradable occluder is gradually replaced by the host's own tissue, leaving only the frame. However, the biodegradable occluder has some potential complications, such as atrial perforation, pericardial effusion, repeated fever and other symptoms caused by the frame. At the same time, the productization of the biodegradable material occluder in the market has not been well certified, and the metal content in the structure is relatively large. Long-term implantation in the heart may cause the occluder to gradually corrode and release toxic substances due to blood corrosion and friction caused by heart beating, which may increase the risk of occurrence of complications. By using nitinol alloy material to manufacture the proximal frame 21 and the distal frame 31 through laser cutting and then heat setting or by a braiding process, the metal content of the whole occluder is greatly reduced, thus effectively reducing the possibility of the above various situations. And making the proximal buckle 22 and the distal buckle 32 of medical stainless steel material can also effectively improve the overall safety performance of the occluder.

[0100] Refer to Figure 8 , optionally, the elastic connecting member 1 includes a connecting spring 11. The proximal end of the connecting spring 11 has a proximal connecting ball 12, and the proximal connecting ball 12 is fixedly connected to the proximal support mechanism 2. The distal end of the connecting spring 11 has a distal connecting ball 13, and the distal connecting ball 13 is fixedly connected to the distal support mechanism 3.

[0101] Specifically, the connecting spring 11 is formed by heat treatment of nitinol wire. Its proximal end forms a proximal connecting ball 12, and the proximal connecting ball 12 is fixedly connected to the proximal connecting hole 214 by argon arc welding process. A distal connecting ball 13 is arranged at the distal end of the connecting spring 11, and the distal connecting ball 13 is fixedly connected to the distal connecting hole 324 by argon arc welding process. Both the proximal connecting ball 12 and the distal connecting ball 13 are fusion balls. In this embodiment, the nitinol wire adopts a 0.25 mm specification and is helically wound 5 turns to form the connecting spring 11. In other embodiments, the nitinol wire can also adopt other thickness specifications, and the number of winding turns is not limited to 5 turns.

[0102] By using a nickel-titanium wire to make the connecting spring 11, the connecting spring 11 has good restorability, and its length can also be set according to the actual application scenario, so as to be applied in the field of the occluder in different environments and improve the adaptability of the occluder.

[0103] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, rather than limiting the implementation manners of the present invention. For those of ordinary skill in the art, various obvious changes, re-adjustments and substitutions can be made without departing from the protection scope of the present invention. It is not necessary and impossible to enumerate all the implementation manners here. Any modifications, equivalent substitutions and improvements made within the spirit and principle of the present invention shall be included in the protection scope of the claims of the present invention.

Claims

1. Occluder, characterized in that, Comprising: a proximal support mechanism (2); a distal support mechanism (3), which is disposed opposite to the proximal support mechanism (2); a proximal flow-blocking membrane, which at least covers one side of the proximal support mechanism (2) facing away from the distal support mechanism (3); a distal flow-blocking membrane, which at least covers one side of the distal support mechanism (3) facing away from the proximal support mechanism (2); and a first suture (4), which is passed through the proximal support mechanism (2) and connected to the distal support mechanism (3); wherein, in a first projection plane, the second part of the proximal support mechanism (2) and the second part of the distal support mechanism (3) both bend and extend in a direction away from the first part, and in a second projection plane, the second part of the proximal support mechanism (2) and the second part of the distal support mechanism (3) both incline towards the side close to each other, and the first projection plane is perpendicular to the second projection plane.

2. The occluder according to claim 1, wherein, The occluder further comprises an elastic connecting member (1), and the elastic connecting member (1) comprises: a connecting spring (11), the proximal end of the connecting spring (11) has a proximal connecting ball (12), the proximal connecting ball (12) is fixedly connected to the proximal support mechanism (2), the distal end of the connecting spring (11) has a distal connecting ball (13), and the distal connecting ball (13) is fixedly connected to the distal support mechanism (3).

3. The occluder according to claim 1, wherein, The proximal support mechanism (2) comprises: a proximal skeleton (21), the second part of the proximal skeleton (21) is fixedly connected to the proximal flow-blocking membrane; and a proximal buckle (22), which is clamped to the first part of the proximal skeleton (21) and fixes the proximal flow-blocking membrane at the first part of the proximal skeleton (21) so that the proximal flow-blocking membrane covers the side of the proximal skeleton (21) facing away from the distal support mechanism (3); wherein, in the first projection plane, the second part of the proximal skeleton (21) bends and extends in a direction away from the first part, and in the second projection plane, the second part of the proximal skeleton (21) inclines towards the side close to the distal support mechanism (3), and the included angle between the inclination direction and the first projection plane is an acute angle; and / or The distal support mechanism (3) comprises: a distal skeleton (31), the second part of the distal skeleton (31) is fixedly connected to the distal flow-blocking membrane; and a distal buckle (32), which is clamped to the first part of the distal skeleton (31) and fixes the distal flow-blocking membrane at the first part of the distal skeleton (31) so that the distal flow-blocking membrane covers the side of the distal skeleton (31) facing away from the proximal support mechanism (2); wherein, in the first projection plane, the second part of the distal skeleton (31) bends and extends in a direction away from the first part of the distal skeleton (31), and in the second projection plane, the second part of the distal skeleton (31) inclines towards the side close to the proximal support mechanism (2), and the included angle between the inclination direction and the first projection plane is an acute angle.

4. The occluder according to claim 3, wherein, The proximal framework (21) includes a proximal support ring (211) and at least two proximal support rods (211). The proximal support rods (212) are distributed in a circular arrangement around the proximal support ring (211), and one end of each proximal support rod (211) is connected to the proximal support ring (211). In the first projection plane, the proximal support rods (212) extend in a curved manner. In the second projection plane, the end of each proximal support rod (212) that is away from the proximal support ring (211) inclines towards the side close to the distal support mechanism (3), and the included angle between the inclination direction and the first projection plane is an acute angle. And / or: The distal framework (31) includes a distal support ring (311) and at least two distal support rods (312). The distal support rods (312) are distributed in a circular arrangement around the distal support ring (311), and one end of each distal support rod (312) is connected to the distal support ring (311). In the first projection plane, the distal support rods (312) extend in a curved manner. In the second projection plane, the end of each distal support rod (312) that is away from the distal support ring (311) inclines towards the side close to the proximal support mechanism (2), and the included angle between the inclination direction and the first projection plane is an acute angle.

5. The occluder according to claim 4, wherein The first projection plane is parallel to the ring plane of the proximal support ring, and the second projection plane is perpendicular to the ring plane of the proximal support ring.

6. The occluder according to claim 4, characterized in that The proximal framework (21) further includes a proximal circular ring (215), which is arranged on the side of the proximal support rod (212) that is away from the proximal support ring (211); and / or The distal framework (31) further includes a distal circular ring (315), and the distal circular ring (315) is arranged at the end of the distal support rod (312) that is away from the distal support ring (311).

7. The occluder according to claim 3, characterized in that, The proximal buckle (22) includes: A proximal clamping ring (221), which abuts against the proximal framework (21) and presses the proximal flow-blocking film onto a first part of the proximal framework (21); and A proximal clamping rod (222), one end of the proximal clamping rod (222) is connected to the proximal clamping ring (221), and the other end of the proximal clamping rod (222) passes through the proximal framework (21) and is fixedly clamped to the proximal framework (21); and / or The distal buckle (32) includes: A distal clamping ring (321), which abuts against the distal support ring (311) and presses the distal flow-blocking film onto the distal support ring (311); and A distal clamping rod (322), one end of the distal clamping rod (322) is connected to the distal clamping ring (321), and the end of the distal clamping rod (322) that is away from the distal clamping ring (321) passes through the distal support ring (311) and is fixedly clamped to the distal support ring (311).

8. The occluder according to claim 3, characterized in that, The proximal framework (21) is made by laser cutting and then heat setting a nitinol alloy material or by using a weaving process; and / or The proximal buckle (22) is made of a medical stainless steel material; and / or The distal end framework (31) is made by laser cutting and heat setting a nitinol alloy material or by using a braiding process; and / or The distal end buckle (32) is made of a medical stainless steel material.

9. The occluder according to claim 7, wherein, The distal end snap ring (321) abuts against one side of the distal end support ring (311) close to the proximal end support mechanism (2), and the distal end snap ring (321) has a notch (323) corresponding to the distal end support rod (312).

10. The occluder according to claim 7, characterized in that, The inner wall of the distal end snap ring (321) is provided with a thread for threaded connection with the delivery system.

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