CN114767180B - Atrial septal defect plugging device - Google Patents

Abstract

The invention relates to a atrial septal defect plugging device, which comprises an elastic woven net rack and a flexible connecting piece, wherein the elastic woven net rack comprises a left disc surface and a right disc surface; the flexible connecting piece comprises a hollow cylindrical waist structure made of flexible connecting sheets, and two ends of the flexible connecting piece are respectively connected with the proximal end of the left disk surface and the distal end of the right disk surface; the flexible connecting sheet is made of high polymer materials with good biocompatibility and elasticity so as to adapt to atrial septal defects with different anatomical forms, improve the plugging effect and ensure that long-term residual shunt is not generated; meanwhile, the metal dosage is reduced, and the harm to human body caused by metal ion release is reduced.

Description

A kind of atrial septal defect occluder

technical field

The invention relates to the field of medical devices for interventional operations, in particular to an atrial septal defect occluder.

Background technique

Atrial septal defect (ASD) is a common clinical congenital heart malformation, which is mainly formed during the production and development of the fetus. Due to some factors, the atrial septum of the heart is abnormal during the embryonic development, resulting in a gap between the left and right atrium. remaining gaps. For patients with atrial septal defect, because the pressure of the left atrium is higher than that of the right atrium, blood usually flows from the left atrium through the atrial septal defect into the right atrium, resulting in increased blood volume in the right atrium, causing right ventricular hypertrophy, and increased blood volume in the pulmonary circulation. Long-term existence of atrial septal defect may lead to pulmonary arterial hypertension (Pulmonary Artery Hypertension, PAH), congestive heart failure (Congestive Heart Failure, CHF), arrhythmia (Arrhythmia), stroke (Stroke), dizziness (Dizziness), fainting (Syncope), etc. disease.

At present, the most widely used clinical treatment of atrial septal defect is the occluder represented by Amplatzer, which includes an integrated left disk, right disk and lumbar connector. The left and right disks of the occluder and the connecting parts at the waist are all rigidly connected to form an integral structure. The principle is to compress the elastic occluder into a smaller structure, transport it to the defect site through the catheter, and the elastic occluder will self-expand and return to a preset shape, and the left and right discs will be in close contact with each other. On the atrial walls on both sides of the atrial septum, the two together clamp the edge of the atrial septal defect.

However, when this type of atrial septal defect occluder is pushed out and released from the delivery device, the distance and relative angle between the left disk surface and the right disk surface cannot be relatively adjusted. In actual clinical operations, due to the existence of individual differences in patients, the corresponding atrial septal defects of patients have different thicknesses and inclination angles. Therefore, the current occluders cannot adapt to atrial septal defects of different anatomical shapes, and the occlusion effect is not good.

Based on the above reasons, how to improve the structure of the atrial septal defect occluder so that it can adapt to atrial septal defects of different anatomical shapes and improve the occlusion effect has become a technical problem that needs to be solved urgently.

Contents of the invention

The invention discloses an atrial septal defect occluder and aims to solve the technical problems in the prior art.

The present invention adopts following technical scheme:

An atrial septal defect occluder, comprising:

- Elastic braided net frame, elastic braided net frame includes left disk surface and right disk surface;

-Flexible connector, the flexible connector includes a hollow cylindrical waist structure made of a flexible connecting sheet, the two ends of the flexible connecting member are respectively connected to the proximal end of the left disk and the far end of the right disk; the flexible connecting sheet is made of biological Made of polymer materials with good compatibility.

As a preferred technical solution, the outer wall of the flexible connecting sheet is coated with a hydrophilic swelling material, which can absorb liquid and swell after being in contact with blood.

As a preferred technical solution, the hydrophilic swelling material includes medical hyaluronic acid material.

As a preferred technical solution, the flexible connector also includes several elastic elements, and the two ends of each elastic element are respectively connected to the proximal end of the left disk surface and the far end of the right disk surface; the flexible connecting sheet has a double-layer structure, and the elastic elements are arranged on the Layers are flexibly connected in the interstices of the sheets.

As a preferred technical solution, the elastic element includes a stretchable spring or an elastic body made of polymer elastic material.

As a preferred technical solution, the axial length of the flexible connecting sheet in a flat state is greater than the axial length of the elastic element in a natural state; the flexible connecting sheet has a continuous wrinkled structure in the axial direction, and the flexible connecting sheet has a wrinkled structure. The axial length is the same as the axial length of the elastic element in its natural state.

As a preferred technical solution, the proximal end of the right disc surface is connected with a fastener, and the fastener is provided with a hollow channel; a locking mechanism is provided on the flexible connecting piece, one end of the locking mechanism is connected with the flexible connecting sheet, and the other end is passed through the tight in the hollow channel of the firmware.

As a preferred technical solution, the fastener includes a steel sleeve.

As a preferred technical solution, the locking mechanism includes several pulling wires and locking elements; one end of the several pulling wires is radially fixed on the inner side of the flexible connecting sheet, and the other ends of the several pulling wires are gathered in one place and connected with the locking element ; The locking element includes a structure that irreversibly enters the hollow passage of the fastener and completes the locking.

As a preferred technical solution, the locking element includes a locking knot, a locking ball or a locking platform.

As a preferred technical solution, there are at least two locking elements.

As a preferred technical solution, the flexible connecting sheet is made of a material with flow resistance.

As a preferred technical solution, the side of the left disc facing the left atrium and/or the side of the right disc facing the right atrium form a flat plane.

As a preferred technical solution, at least one puncture hole is correspondingly opened on the left disk surface and the right disk surface, and the size of the puncture hole is larger than the mesh size of the elastic braided grid frame.

As a preferred technical solution, a choke film is also included, and the choke film includes: a left disk choke film arranged on the left disk surface and a right disk choke film arranged on the right disk surface.

As a preferred technical solution, the flow blocking film is made of biodegradable materials.

The technical scheme adopted in the present invention can achieve the following beneficial effects:

(1), the present invention provides an atrial septal defect occluder, comprising a left disk and a right disk woven by elastic metal wires, the waist structure composed of a braided grid is canceled between the left disk and the right disk, and replaced by The most important thing is to connect the left and right disc surfaces respectively through flexible connectors, among which the flexible connectors can be made of materials with good biocompatibility and elasticity, so as to adapt to atrial septal defects of different anatomical shapes, improve the sealing effect, and ensure There is no long-term residual shunt; at the same time, the amount of metal used is reduced, and the harm caused by the release of metal ions to the human body is reduced.

(2) In order to adapt to various forms of atrial septal defect, the outer wall of the flexible connecting element is coated with a coating made of hydrophilic swelling material. After implanting in the defect, as time goes by, the hydrophilic swelling material will come into contact with blood It can absorb liquid and expand to adapt to different shapes of atrial septal defect holes to ensure that the waist of the occluder and the defect hole are fully filled and fit, thereby preventing the occurrence of residual shunt.

(3), the above-mentioned flexible connection element is preferably a double-layer film structure, and an elastic element is also embedded in the middle of the double-layer structure. The film structure can be a flexible connection sheet, and the elastic element can be made of a stretchable spring or a polymer elastic material. The elastic body forms a "sandwich" structure, so that when the occluder is implanted in the atrial septal defect, since the flexible connecting sheet can be stretched and rebounded, the operator can flexibly adjust it according to the specific anatomical shape of the defect site. The relative angle between the left disc surface and the right disc surface enables the occluder to better match the physiological and anatomical structure of the defect site, ensuring the occlusion effect. At the same time, due to the setting of the elastic element, the relative distance between the left disc surface and the right disc surface of the occluder can also be adjusted within a certain range. On the basis of ensuring the clamping force between the left disc surface and the right disc surface, it can also make The occluder can be applied to more types of different patients.

(4) The flexible connecting sheet of the above-mentioned flexible connecting element preferably forms a series of wrinkles in the axial direction to provide space for the stretching of the flexible connecting sheet to facilitate further adjustment of the relative distance and angle between the left and right disc surfaces.

(5), in the occluder of the present invention, the proximal end of the right disc surface is also preferably provided with a fastener, and a locking mechanism is provided in the flexible connector, and the locking mechanism further includes a pulling wire and a locking element, and one end of the pulling wire It is radial and connected with the inner wall of the flexible connector, and the other end is brought together and connected with the locking element; the locking element can irreversibly enter the inner channel of the fastener and complete the locking; when the doctor performs the operation, it can be used according to the actual condition of the atrial septal defect The shape adjusts the axial length of the flexible connector to meet the actual plugging requirements and ensure a good plugging effect.

(6), the left disc surface and the right disc surface of the occluder are preferably provided with a flow-blocking film, and the flexible connecting sheet used to form the flexible connector is also made of a material with flow-blocking properties. After the shape of the parts is locked, the flexible connecting sheet converges to the central part to further enhance the flow blocking effect of the occluder.

(7), in a preferred embodiment, the left and right disk surfaces of the occluder, especially the left disk surface corresponding to the left atrium, can be set as a smooth plane, which is conducive to accelerating the endothelialization process and reducing the occurrence of thrombus. stroke risk.

(8) In a preferred embodiment, several puncture holes are correspondingly opened on the left and right disk surfaces of the occluder, and the size of the puncture holes is suitable for future interventional surgery punctures, and the left and right disk surfaces The blocking membrane is made of biodegradable materials and covers the puncture hole. After the occluder is implanted into the human endothelium, the blocking membrane gradually degrades and absorbs, which is convenient for atrial septal puncture.

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings that need to be used in the description of the embodiments will be briefly introduced below, which constitute a part of the present invention. The schematic embodiments of the present invention and their descriptions explain the present invention , does not constitute an improper limitation of the present invention. In the attached picture:

FIG. 1 is a schematic structural view of an atrial septal defect occluder disclosed in a preferred embodiment of Example 1 of the present invention;

Fig. 2 is a schematic structural view of the atrial septal defect occluder disclosed in another preferred embodiment of Example 1 of the present invention;

Fig. 3 is a schematic structural diagram of a flexible connector disclosed in a preferred implementation of Example 2 of the present invention;

Fig. 4 is a schematic structural diagram of a flexible connector disclosed in another preferred embodiment of Example 2 of the present invention;

Fig. 5 is a perspective view of a flexible connector disclosed in a preferred implementation of Example 2 of the present invention;

Fig. 6 is a schematic structural view of the atrial septal defect occluder disclosed in a preferred implementation of Example 3 of the present invention;

Fig. 7 is a schematic structural view of the atrial septal defect occluder disclosed in another preferred implementation of Example 3 of the present invention.

Explanation of reference signs:

Right disk surface 1, left disk surface 2, rivet head 3, flexible connector 4, flexible connection sheet 41, elastic body 42', retractable spring 42, traction wire 5, locking element 6, fastener 7.

Detailed ways

In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is usually used in the sense of including "and/or", unless the content clearly states otherwise.

In the description of the present invention, it should be noted that unless otherwise specified and limited, the terms "installation", "connection" and "connection" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; either directly or indirectly through an intermediary. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention in specific situations. The structures, proportions, sizes, etc. shown in the drawings attached to this specification are only used to match the content disclosed in the specification for the understanding and reading of those who are familiar with this technology, and are not used to limit the conditions for the implementation of the present invention , so it has no technical substantive meaning, and any modification of structure, change of proportional relationship or adjustment of size shall still fall within the scope of the disclosure of the present invention without affecting the functions and objectives of the present invention. The technical content must be within the scope covered. At the same time, terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description and are not used to limit this specification. The scope of the invention can be implemented.

Apparently, the described embodiments are only some of the embodiments of the present invention, but not all of them. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

In order to solve the problems existing in the prior art, the embodiment of the present application provides an atrial septal defect occluder, the occluder includes an elastic braided grid and a flexible connector, wherein the elastic braided grid includes a left disk surface and a right disk surface The flexible connector includes a hollow cylindrical waist structure made of a flexible connecting sheet, and the two ends of the flexible connecting member are respectively connected to the proximal end of the left disk surface and the far end of the right disk surface; the flexible connecting sheet is made of a biocompatible made of polymer materials.

Example 1

This embodiment 1 provides an atrial septal defect occluder, which can flexibly adjust the distance and angle between the left disk surface 2 and the right disk surface 1 after being implanted in the human body, so as to ensure that the occluder can be applied to various anatomies The shape of atrial septal defect provides a sealing effect and ensures that no long-term residual shunt will occur.

Referring to Figures 1-2, the atrial septal defect occluder includes an elastic braided grid and a flexible connector 4, wherein the elastic braided grid includes a left disc surface 2 and a right disc surface 1, which are respectively positioned on the The left atrium and the right atrium; the flexible connector 4 is a hollow cylindrical waist structure, and its two ends are respectively connected to the proximal end of the left disc 2 and the distal end of the right disc 1, and the flexible connector 4 is positioned in the hole of the atrial septal defect.

Preferably, the flexible connecting piece 4 is made of a flexible connecting sheet 41, and the flexible connecting sheet 41 can be made of a biocompatible polymer material, which ensures a certain modulus of elasticity while providing support, so that the left The angle and distance between the disk surface 2 and the right disk surface 1 can be adjusted and changed according to the actual shape of the atrial septal defect; optional, biocompatible polymer materials are recombinant peptides, chemically synthesized peptides, and recombinant peptides. One or both of gelatin, chemically synthesized gelatin, polycaprolactone, polylactic acid, polyurethane, polyglycolic acid, polycaproic acid amide, polylactic acid-glycolic acid copolymer, collagen, silk protein, cellulose, and chitosan a mixture of the above.

Preferably, the flexible connecting part 4 is connected to the elastic braided network frame by means of biocompatible glue bonding, hot melting, sewing or laser welding.

Preferably, the outer wall of the flexible connector 4 is coated with a coating made of a hydrophilic swelling material. After being implanted in a defect, as time goes on, the hydrophilic swelling material can absorb liquid and expand in contact with blood to adapt to different shapes. The hole of atrial septal defect ensures that the waist of the occluder and the defect hole are fully filled and fit, thereby preventing the occurrence of residual shunt. The hydrophilic swelling material is preferably a hyaluronic acid material.

Both the left disk surface 2 and the right disk surface 1 are formed by cross-braiding multiple elastic metal wires with memory function, preferably nickel-titanium alloy metal wires; during production, multiple nickel-titanium wires are cross-braided in two directions to form two cylindrical network pipes, and shape them into two disk-shaped or umbrella-shaped structures at a certain temperature, and then connect the two ends of the flexible connector 4 with the two cylindrical network pipes respectively; After being inserted into the human body and unfolded, the left disk 2 is positioned on the left atrium, and the right disk 1 is positioned on the right atrium, both clamp the atrial septal defect together, and the flexible connector 4 connecting the left disk 2 and the right disk 1 is positioned on the atrial septal defect middle.

As shown in Figure 2, preferably, the left and right disk surfaces 1 of the occluder, especially the left disk surface 2 corresponding to the left atrium, are set as a flat plane, which is conducive to increasing the contact area with the interatrial septum to speed up the endothelialization process , while reducing the risk of stroke caused by blood clots. Optionally, since patients have different ages, genders, heights, weights, atrial septal defect locations, and defect shapes, etc., in order to adapt to different shapes/sizes of atrial septal defects and play a better role, left disk 2, The size of the right disk surface 1 and the flexible connecting member 4 can be adjusted or selected adaptively, and will not be repeated here.

As shown in Figure 1, preferably, after the braiding of the elastic braided grid frame is completed, the elastic metal wires are gathered at the central positions of the far end of the left disc surface 2 and the proximal end of the right disc surface 1 respectively, so that at the far end of the left disc surface 2 and the right disc surface 1 The proximal end is connected with a rivet 3, and the rivet 3 is used to fix the elastic wire, and can be connected with the pushing device of the occluder to push the occluder from the delivery catheter to the atrial septal defect and release it.

Preferably, a left disk choke film and a right disk choke film are respectively provided on the left disk surface 2 and the right disk surface 1. It is sutured on the corresponding positions of the left disk surface 2 and the right disk surface 1, and is used to block the blood flow at the atrial septal defect; optionally, the flow blocking membrane is made of polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxy Fatty acid ester, polydioxanone, polycaprolactone, polyamide, polyanhydride, polyphosphate, polyurethane or polycarbonate, or a copolymer of at least two of the above polymer monomers.

Preferably, a flow blocking film is also provided in the axial middle of the flexible connector 4. If the left disk 2 and the right disk 1 cannot fit the interatrial septum in some cases and present a dumbbell-shaped shape, the left disk 2 2, the blood flowing into the occluder will be completely blocked by the choke membrane to prevent the occurrence of residual shunt.

Example 2

Referring to Fig. 3-5, this embodiment provides a preferred structure of an atrial septal defect occluder.

The atrial septal defect occluder includes an elastic braided mesh frame and a flexible connector 4. The elastic braided mesh frame includes a left disk surface 2 and a right disk surface 1. Its specific structure is the same as that in Embodiment 1 above. Sheet 41 and several elastic elements.

In a preferred embodiment, the flexible connecting member 4 includes a double-layer flexible connecting sheet 41 and an elastic element arranged in the middle of the double-layer flexible connecting sheet 41, preferably, the flexible connecting sheet 41 in this embodiment The materials used in the above-mentioned embodiment 1 are the same; optionally, the elastic element is a stretchable spring 42 or an elastic body 42' made of a polymer elastic material; preferably, the polymer elastic material includes natural rubber, butadiene It is made of at least one of nitrile rubber, polyurethane elastomer, silica gel, and vinyl resin. Preferably, the elastic body 42' is sandwiched in the middle of the double-layer flexible connecting sheet 41 in a flat strip shape, and the elastic body 42' The two ends are respectively connected to the proximal end of the left disk surface 2 and the distal end of the right disk surface 1; more preferably, the elastic element is a flat telescopic spring 42, and the two ends of each telescopic spring 42 are respectively connected to the proximal end of the left disk surface 2 and the distal end of the right disc surface 1, the stretchable spring 42 has better mechanical strength than the elastic body 42' made of polymer elastic material, and can provide better stability after being implanted in the heart.

As shown in Fig. 5 , in the above-mentioned embodiment, the double-layer flexible connecting sheet 41 and the elastic element arranged in the middle of the double-layer flexible connecting sheet 41 form a structure similar to a "sandwich", so that the occluder is implanted in the atrial septum. When there is a defect, since the flexible connecting sheet 41 can be stretched and rebounded, the operator can flexibly adjust the relative angle between the left disk surface 2 and the right disk surface 1 according to the specific anatomical shape of the defect site, so that the occluder and the defect The physiological and anatomical structure of the site can be better matched to ensure the sealing effect. At the same time, due to the setting of the elastic element, the relative distance between the left disk surface 2 and the right disk surface 1 of the occluder can also be adjusted within a certain range, on the basis of ensuring the clamping force between the left disk surface 2 and the right disk surface 1 , can also make the occluder applicable to more types of different patients.

In a more preferred embodiment, the axial length of the flexible connecting sheet 41 in a flat state is greater than the axial length of the elastic element in a natural state without stretching. When the flexible connecting piece 4 is produced, the elastic element is stretched. In the long state, it is installed and connected with the flexible connecting sheet 41. After the installation is completed, the flexible connecting sheet 41 shrinks in the axial direction to form a series of folded structures, which can provide space for the stretching of the flexible connecting sheet 41 , to facilitate the adjustment of the relative distance between the left and right discs.

Preferably, the outer wall of the flexible connection sheet 41 of the outer layer is also coated with a coating made of a hydrophilic swelling material. The hydrophilic swelling material is preferably a hyaluronic acid material, which can absorb moisture in the blood and expand, which is beneficial to the outer layer. The flexible connecting sheet 41 is fully filled in the gap of the atrial septal defect.

Example 3

Referring to Fig. 6-7, this embodiment provides a preferred structure of an atrial septal defect occluder.

The atrial septal defect occluder includes an elastic braided grid and a flexible connector 4. The elastic braided grid includes a left disc surface 2 and a right disc surface 1. The specific structure of the two is the same as that in the above-mentioned embodiment 1. The flexible connector 4 includes The structure and material of the flexible connecting sheet 41 are the same as those in Embodiment 1.

In a preferred embodiment, a fastener 7 is provided at the proximal end of the right disc surface 1 , and a locking mechanism is provided inside the flexible connecting member 4 . Preferably, the fastener 7 is a cylindrical steel sleeve, and its structure can be the same as that of the rivet head 3 in Embodiment 1; preferably, the locking mechanism includes several pulling wires 5 and a locking element 6 arranged at one end of the pulling wire 5 , the locking element 6 passes through the hollow channel of the fastener 7 .

Preferably, several pulling wires 5 are radially fixed on the inner wall of the flexible connector 4, and specifically can be fixed with the flexible connector 4 by means of biocompatible glue bonding, hot melting, sewing or laser welding; optional , several pulling wires 5 are fixed at the distal end of the flexible connector 4 at the same time, as shown in Figure 6; optionally, several pulling wires 5 are fixed at the middle position of the flexible connecting member 4, as shown in Figure 7; preferably, each pulling The wires 5 are respectively fixed at different positions of the flexible connector 4 to adjust more angles of the flexible connector 4, so that the left disk surface 2 and the right disk surface 1 can be adjusted according to the actual shape of the atrial septal defect.

Preferably, the locking element 6 includes a structure that irreversibly enters the hollow channel of the fastener 7 and can complete the locking of the pulling wire 5. Optionally, the locking element 6 can be set as a locking knot, a locking ball or a locking platform, as shown in Figure 6 And FIG. 7 , which provides an embodiment of the locking element 6 , which is set as a locking ball structure, so as to limit and fix the pulling wire 5 . Preferably, multiple locking elements 6 can be provided, so as to adjust the axial length of the flexible connecting sheet 41 reasonably according to actual requirements to meet the blocking requirements.

In a preferred embodiment, the flexible connecting sheet 41 is made of a material with flow-resistance properties, and when it is locked by the locking mechanism, the flexible connecting sheet 41 converges toward the central part as a whole, further enhancing the stability of the occluder. Choke effect.

In this embodiment, when the doctor performs the operation, the length of each pulling wire 5 is adjusted by the locking element 6, and the axial length of the flexible connecting member 4 can be adjusted according to the actual shape of the atrial septal defect, so as to adapt to the actual sealing. Blocking demand, to ensure a good blocking effect.

Example 4

Referring to Fig. 3-7, this embodiment provides a preferred structure of an atrial septal defect occluder.

The atrial septal defect occluder includes an elastic braided mesh frame, a flexible connector 4, a locking mechanism and a fastener 7, wherein the structures of the elastic braided mesh frame, the locking mechanism and the fastener 7 are the same as those in Embodiment 3, and The flexible connector 4 is the same as the structure 1 in the second embodiment.

In a preferred embodiment, the elastic braided network frame includes a left disk surface 2 and a right disk surface 1, and the flexible connecting member 4 includes a double-layer flexible connecting sheet 41 and elastic elements, and several pulling wires are fixed on the flexible connecting sheet of the inner layer. 5. The other end of the pulling wire 5 is collected and connected to the locking element 6, and the locking element 6 is passed through the hollow channel of the fastener 7.

In this embodiment, the operation method and workflow of the above-mentioned atrial septal defect occluder are as follows:

When using the atrial septal defect occluder according to the present invention, first connect the push rod to the fastener 7, and push the handle to push the push rod forward, so that the atrial septal defect occluder is pushed from the delivery catheter to the At the patient's atrial septal defect, the occluder is released from the delivery catheter at this time, the left disk 2 is released and fixed on the left atrium, the flexible connector 4 is positioned at the atrial septal defect, and finally the right disk 1 is released and fixed on the Right atrium, when the position of the occluder is anchored, adjust the length of each pulling wire 5 through the adjustment mechanism connected to the locking element 6, so as to adjust the axial length of the flexible connector 4 according to the actual wall thickness of the atrial septal defect , to meet the occlusion requirement, when the adjustment is completed, twist the push rod to disengage it from the fastener 7, so that the push rod is separated from the occluder.

For the occluder anchored at the atrial septal defect, the outer wall of the flexible connector 4 is coated with a hydrophilic swelling material, which can absorb moisture in the blood and expand, so that the flexible connector 4 fits better with the shape of the defect and fit to prevent residual shunting from occurring.

Example 5

This embodiment provides a preferred structure of an atrial septal defect occluder. On the basis of any one of the above-mentioned embodiments 1-4, this embodiment further changes the structure of the elastic braided grid.

Preferably, at least one puncture hole is correspondingly opened on the left disk surface 2 and the right disk surface 1. Preferably, the size of the puncture hole is larger than the mesh size of the elastic braided mesh frame. More preferably, the size of the puncture hole is suitable for intervention in the future. For surgical puncture.

The flow blocking membranes in the left disk 2 and the right disk 1 are made of biodegradable materials and cover the puncture holes. After the occluder is implanted into the human endothelium, the flow blocking membranes are gradually degraded and absorbed, which is convenient for puncturing atrial septal puncture surgery.

In this embodiment, since some patients may encounter interventional operations requiring other heart diseases after interventional closure of patent foramen ovale or atrial septal defect, such as atrial septal puncture , Indications for atrial septal puncture include left atrial ablation, left atrial appendage closure, percutaneous mitral valve repair, etc. Therefore, after the atrial septum occluder described in this embodiment is implanted, since the occluder is provided with a puncture hole, and the blocking membrane can be absorbed and degraded, it is easier for the puncture needle to pass through the atrial septum through the position of the puncture hole. The septal tissue can avoid the resistance of the blocking membrane to the puncture needle, and can pass through other sheath catheters smoothly after the puncture is completed, so as to facilitate other interventional operations after atrial septal puncture.

Embodiments of the present invention have been described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementations, and the above-mentioned specific implementations are only illustrative, rather than restrictive, and those of ordinary skill in the art will Under the enlightenment of the present invention, without departing from the gist of the present invention and the protection scope of the claims, many forms can also be made, all of which belong to the protection of the present invention.

Claims (14)

1. A kind of atrial septal defect occluder, is characterized in that, comprises: - Elastic woven grid, the elastic woven grid includes a left disk surface and a right disk surface; - a flexible connecting piece, the flexible connecting piece includes a hollow cylindrical waist structure made of a flexible connecting sheet, the two ends of the flexible connecting piece are respectively connected to the proximal end of the left disk surface and the far end of the right disk surface end; the flexible connecting sheet is made of a biocompatible polymer material; The flexible connector also includes a number of elastic elements, the two ends of each elastic element are respectively connected to the proximal end of the left disk surface and the far end of the right disk surface; the flexible connecting sheet is a double-layer structure, so The elastic element is arranged in the gap between the double-layered flexible connecting sheets. 2. The atrial septal defect occluder according to claim 1, wherein the outer wall of the flexible connecting sheet is coated with a hydrophilic swelling material, and the hydrophilic swelling material can absorb liquid and expand after being in contact with blood . 3. The atrial septal defect occluder according to claim 2, wherein the hydrophilic swelling material comprises medical hyaluronic acid material. 4. The atrial septal defect occluder according to claim 1, wherein the axial length of the flexible connecting sheet in a flat state is greater than the axial length of the elastic element in a natural state; the flexible connecting sheet The sheet has a continuous wrinkled structure in the axial direction, and the flexible connecting sheet has the same axial length in a wrinkled state as that of the elastic element in a natural state. 5. The atrial septal defect occluder according to claim 4, wherein the elastic element comprises a stretchable spring or an elastic body made of polymer elastic material. 6. The atrial septal defect occluder according to claim 1, wherein the proximal end of the right disk is connected with a fastener, and the fastener is provided with a hollow channel; the flexible connector is provided with a There is a locking mechanism, one end of the locking mechanism is connected to the flexible connecting sheet, and the other end is passed through the hollow channel of the fastener; The locking mechanism includes several pulling wires and locking elements; one end of the several pulling wires is radially fixed on the inner side of the flexible connecting sheet, and the other ends of the several pulling wires are assembled in one place and connected to the The locking element is connected; the locking element includes a structure that irreversibly enters into the hollow channel of the fastener and completes the locking. 7. The atrial septal defect occluder according to claim 6, wherein the fastening element comprises a steel sleeve. 8. The atrial septal defect occluder according to claim 6, wherein the locking element comprises a locking knot, a locking ball or a locking platform. 9. The atrial septal defect occluder according to claim 6, wherein there are at least two locking elements. 10 . The atrial septal defect occluder according to claim 6 , wherein the flexible connecting sheet is made of a material with flow resistance. 11 . 11 . The atrial septal defect occluder according to claim 1 , wherein the side of the left disk facing the left atrium and/or the side of the right disk facing the right atrium form a flat plane. 12. The atrial septal defect occluder according to claim 1, wherein at least one puncture hole is correspondingly provided on the left disk surface and the right disk surface, and the size of the puncture hole is larger than that of the elastic braided mesh Mesh size of rack. 13. The atrial septal defect occluder according to any one of claims 1-12, further comprising a flow blocking membrane, the flow blocking membrane comprising: a left disk blocking membrane arranged on the left disk surface And the right disk choke film arranged on the right disk surface. 14. The atrial septal defect occluder according to claim 13, wherein the blocking membrane is made of biodegradable materials.

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