WO2022042717A1

WO2022042717A1 - Left atrial appendage occluder

Info

Publication number: WO2022042717A1
Application number: PCT/CN2021/115265
Authority: WO
Inventors: 李建民; 丘家明; 王永胜
Original assignee: 杭州德诺电生理医疗科技有限公司
Priority date: 2020-08-31
Filing date: 2021-08-30
Publication date: 2022-03-03

Abstract

A left atrial appendage occluder (100), comprising a sealing disc (10), an anchoring structure (30) and at least two covering films (50). The sealing disc (10) is fixedly connected to the anchoring structure (30), and the at least two covering films (50) are arranged at intervals and cover the surface of different areas on the anchoring structure (30) so that two adjacent covering films (50) do not interfere with each other and do not pull each other, especially when the covering films (50) are squeezed and deformed by a cavity wall of a left atrial appendage. Compared with the technical solution in the prior art that a whole covering film (50) is arranged on the surface of the anchoring structure (30), the manner of arranging the covering films (50) at the surface of different areas in the present application reduces the constraint of the covering films (50) on the anchoring structure (30), and the contribution of the covering films (50) to the radial support force of the anchoring structure (30) reduces the probability of damage to the cavity wall of the left atrial appendage caused by excessive radial support force of the anchoring structure (30).

Description

Left atrial appendage occluder

This application is required to be submitted to the State Intellectual Property Office of China on August 31, 2020, the application number is 2020109014185 (the application name is "left atrial appendage occluder"), and the application number is 202021867389.7 (the application name is "left atrial appendage occluder") The priority of the Chinese patent application of , the entire contents of which are incorporated by reference in this application.

technical field

The present application relates to medical devices, in particular to a left atrial appendage occluder that can be delivered to a selected part of the human body by percutaneous puncture.

Background technique

Percutaneous puncture technology has been used more and more in the treatment of diseases. Through this technology, a variety of materials, devices and drugs can be placed into the heart and arteriovenous vessels of the human body. For example, a left atrial appendage occluder can be placed in the left atrial appendage to block the entrance of the left atrial appendage cavity and block all or most of the blood flow to the left atrial appendage cavity, thereby preventing the left atrial appendage cavity due to atrial fibrillation. Form a thrombus to eliminate the stroke caused by the thrombus ascending to the brain; or prevent the thrombus from reaching other parts of the body through the human blood circulation system, causing systemic embolism.

The left atrial appendage occluder is divided into two types: one-piece and split-type. The integrated type means that the left atrial appendage occluder needs to be fully inserted into the left atrial appendage cavity, and the split type means that the left atrial appendage occluder includes a sealing disc and an anchoring disc connected to the sealing disc. Transcatheter delivery to the entrance of the left atrial appendage cavity and re-deployment, wherein the sealing disc is used to cover the entrance, blocking all or most of the blood flow to the left atrial appendage, and the anchoring disc is usually inserted into the inner wall of the left atrial appendage cavity Or in the tissue near the entrance, or fixed in the left atrial appendage cavity according to its own pressing force on the left atrial appendage cavity wall, so that the sealing disc is positioned at the aforementioned entrance to prevent the occluder from falling off and to avoid blocking leakage as much as possible, So as to play a good blocking effect.

For the split-type left atrial appendage occluder, the surface of the anchoring disc is covered with a blocking membrane. The local irritation of the metal disc surface of the occluder to the cardiac tissue and the risk of thrombosis. However, the radial support force of the anchoring disc of the left atrial appendage occluder is too large due to the restraint of the membrane, so that the pressing force of the anchoring disc on the wall of the left atrial appendage cavity is too large, which is likely to cause complications.

SUMMARY OF THE INVENTION

In order to solve the aforementioned problems, the present application provides a left atrial appendage occluder capable of avoiding excessive radial support force of the anchoring disc.

The present application provides a left atrial appendage occluder, which is characterized in that it includes a sealing disc, an anchoring structure and at least two films, the sealing disc is fixedly connected to the anchoring structure, and the at least two films are spaced apart from each other. set and cover the surface of different areas on the anchoring structure.

In one embodiment, the anchoring structure includes a connecting portion and an anchoring portion, the connecting portion is connected between the anchoring portion and the sealing disc and extends from one end of the sealing disc to the distal end The anchoring part is formed by the distal end of the connecting part being bent and extending toward the proximal end, the connecting part is accommodated in the anchoring part, and the anchoring part and the connecting part together form a cavity. , the at least two films cover at least one of the connecting portion and the anchoring portion.

In one embodiment, the distal end of the connecting portion is funnel-shaped and surrounds an opening, and at least part of the connecting portion is located between the cavity and the opening.

In one embodiment, at least a part of the covering film covers the opening, and the part of the covering film located at the opening is recessed toward the proximal end.

In one embodiment, the side of the anchoring structure facing the cavity is the inner side, the side of the anchoring structure facing away from the cavity is the outer side, and at least one piece of the film covers the anchoring structure. The outside of the structure, and/or at least one piece of the film covers the inside of the anchoring structure.

In one embodiment, at least one piece of the film covers the anchor portion, at least one piece of the film covers the connection portion, and the film located at the anchor portion and the film located at the connection portion. A gap is formed between the membranes.

In one embodiment, the gap is annular.

In one embodiment, at least two sheets of the coating film are arranged along the circumferential direction of the anchoring portion and cover the anchoring portion.

In one embodiment, a gap is formed between adjacent films, and a portion of the gap at the anchor portion extends along the axial direction of the anchor portion.

In one embodiment, at least part of the at least two films also covers the connecting portion.

In one embodiment, the portion of the gap located at the connecting portion extends along the radial direction of the connecting portion, and the gap between the at least two films communicates at the opening.

In one embodiment, at least one piece of the cover film includes a first connection point, a second connection point and a third connection point, the cover film is fixedly connected to the connection portion at the first connection point, and the The cover film is fixedly connected to the anchor portion at the second connection point and the third connection point.

In one embodiment, along the first direction of the anchoring structure, the full length of at least one of the covering films is greater than the extended length of the area covered by the covering film in the anchoring portion.

In one embodiment, the surface of the anchoring structure includes a first area and a second area located in different ranges in at least one direction in the first direction, at least one of the coating films is provided with a raised area and a recessed area, the The raised area covers the first area correspondingly, the recessed area covers the second area correspondingly, and the gap between the film in the raised area and the first area is larger than the film in the recessed area gap with the second area.

In one embodiment, the first direction is the circumferential direction and/or the axial direction of the anchoring portion.

In one embodiment, it also includes a barb fixedly connected to the anchoring portion, the barb includes a barb connecting portion and a barb suspended portion, and the barb connecting portion is fixedly connected to the barb suspended portion Between the anchoring portion and the barb suspended portion, the barb suspended portion extends toward the side where the sealing disc is located.

In one embodiment, at least part of the covering film covers the outer side of the anchoring portion, the barb connecting portion passes through the covering film, and the barb suspended portion and the anchoring portion are respectively located at both sides of the film.

In one embodiment, it also includes a sealing film covering the sealing disc.

The left atrial appendage occluder provided by the present application includes a plurality of covering films arranged at intervals and covering the surfaces of different regions on the anchoring structure, so that two adjacent covering films do not interfere with each other and do not pull each other, especially When the film is squeezed and deformed by the wall of the left atrial appendage, compared with the technical solution of disposing a whole piece of film on the surface of the anchoring structure in the prior art, the above-mentioned block arrangement of the film in the present application reduces the size of the film. The restraint of the anchoring structure and the contribution of the membrane to the radial support force of the anchor structure reduce the probability of damage to the left atrial appendage cavity wall caused by the excessive radial support force of the anchor structure.

Description of drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings that are used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present application, and for those of ordinary skill in the art, other drawings can also be obtained from these drawings without creative effort.

FIG. 1 is a schematic three-dimensional structural diagram of the left atrial appendage occluder provided by the first embodiment of the present application.

FIG. 2 is a schematic plan view of the left atrial appendage occluder shown in FIG. 1 .

FIG. 3 is a schematic cross-sectional view of the left atrial appendage occluder shown in FIG. 2 along F-F.

FIG. 4 is another schematic plan view of the left atrial appendage occluder shown in FIG. 1 .

FIG. 5 is another schematic plan view of the left atrial appendage occluder shown in FIG. 1 .

FIG. 6 is a schematic diagram of an application scenario of the left atrial appendage occluder shown in FIG. 1 .

FIG. 7 is a schematic three-dimensional structural diagram of the left atrial appendage occluder provided by the second embodiment of the present application.

FIG. 8 is a schematic plan view of the left atrial appendage occluder shown in FIG. 7 .

FIG. 9 is a schematic cross-sectional view of the left atrial appendage occluder shown in FIG. 8 along F-F.

FIG. 10 is another schematic plan view of the left atrial appendage occluder shown in FIG. 7 .

FIG. 11 is a schematic three-dimensional structural diagram of the left atrial appendage occluder provided by the third embodiment of the present application.

FIG. 12 is a schematic plan view of the left atrial appendage occluder shown in FIG. 11 .

FIG. 13 is a schematic cross-sectional view along A-A of the left atrial appendage occluder shown in FIG. 12 .

FIG. 14 is another schematic plan view of the left atrial appendage occluder shown in FIG. 11 .

FIG. 15 is a partial structural schematic diagram of the anchoring structure and the membrane of the left atrial appendage occluder shown in FIG. 11 .

FIG. 16 is a schematic plan view of the left atrial appendage occluder provided by the fourth embodiment of the present application.

FIG. 17 is a schematic cross-sectional view of the left atrial appendage occluder shown in FIG. 16 along F-F.

FIG. 18 is a schematic three-dimensional structural diagram of the left atrial appendage occluder shown in FIG. 16 .

FIG. 19 is another schematic plan view of the left atrial appendage occluder shown in FIG. 16 .

FIG. 20 is a schematic plan view of the left atrial appendage occluder provided by the fifth embodiment of the present application.

FIG. 21 is a schematic cross-sectional view of the left atrial appendage occluder shown in FIG. 20 along F-F.

FIG. 22 is a schematic three-dimensional structural diagram of the left atrial appendage occluder shown in FIG. 20 .

FIG. 23 is a schematic plan view of the left atrial appendage occluder provided by the sixth embodiment of the present application.

FIG. 24 is a schematic cross-sectional view along A-A of the left atrial appendage occluder shown in FIG. 23 .

FIG. 25 is a schematic three-dimensional structural diagram of the left atrial appendage occluder shown in FIG. 23 .

FIG. 26 is a schematic three-dimensional structural diagram of the left atrial appendage occluder provided by the seventh embodiment of the present application.

FIG. 27 is a schematic plan view of the left atrial appendage occluder shown in FIG. 26 .

FIG. 28 is a schematic cross-sectional view of the left atrial appendage occluder shown in FIG. 27 along F-F.

FIG. 29 is another schematic plan view of the left atrial appendage occluder shown in FIG. 26 .

detailed description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, but not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present application.

In the technical field of interventional medical devices, the position close to the operator is generally defined as the proximal end, and the position away from the operator is defined as the distal end; the direction of the central axis of rotation of objects such as cylinders and tubes is defined as the axial direction.

first embodiment

Referring to FIG. 1 , the first embodiment of the present application provides a left atrial appendage occluder 100 capable of avoiding excessive radial support force, including a sealing disc 10 , an anchoring structure 30 and three films 50 . The sealing disc 10 and the The anchoring structure 30 is fixedly connected, and the three films 50 are arranged at intervals and cover the surface of the anchoring structure 30 in different areas.

The left atrial appendage occluder 100 provided in the present application includes a plurality of membranes 50 arranged at intervals and covering the surfaces of different regions on the anchoring structure 30, so that two adjacent membranes 50 do not interfere with each other and do not Pulling each other, especially when the coating 50 is squeezed and deformed by the wall of the left atrial appendage, compared to the technical solution of disposing the entire coating 50 on the surface of the anchoring structure 30 in the prior art, the above-mentioned points of the coating 50 in the present application are: The block arrangement reduces the restraint of the film 50 on the anchoring structure 30, and the contribution of the film 50 to the radial support force of the anchor structure 30, and reduces the radial support force of the anchor structure 30 which is too large and causes damage to the left atrial appendage cavity. chance of damage to the wall.

Please refer to FIG. 1 , FIG. 2 and FIG. 3 , the anchoring structure 30 includes a connecting portion 31 , an anchoring portion 33 and a constricting portion 35 . The connecting portion 31 is connected between the anchoring portion 33 and the sealing disc 10 , and is connected by the sealing disc One end of 10 is formed to extend to the distal end, and the distal end of the connecting portion 31 is funnel-shaped and surrounds an opening 36 , and the opening 36 faces the distal end. The anchoring portion 33 is formed by bending and extending from the distal end of the connecting portion 31 toward the proximal end, the anchoring portion 33 is cylindrical, and the anchoring portion 33 is spaced from the sealing disc 10 . The connecting portion 31 is accommodated in the anchoring portion 33 , the anchoring portion 33 is arranged around the periphery of the connecting portion 31 , and the mutually adjacent surfaces of the anchoring portion 33 and the connecting portion 31 together form a cavity 34 . In this embodiment, the side of the connecting portion 31 and the anchoring portion 33 facing the cavity 34 is the inside, and the side of the connecting portion 31 and the anchoring portion 33 away from the cavity 34 is the outside. The outer side of the connecting portion 31 and the anchoring portion 33 . The three sheets of coating film 50 are arranged along the circumferential direction of the anchor portion 33 . A gap is formed between adjacent films 50 , that is, three gaps 51 are formed between three films 50 . The portion of each gap 51 at the anchor portion 33 extends along the axial direction of the anchor portion 33 . The portion of each gap at the connecting portion 31 extends along the radial direction of the connecting portion 31 , and the three gaps 51 communicate with the opening 36 , specifically, the three gaps 51 communicate with the central axis of the anchoring structure 30 . The portion of the membrane 50 at the opening 36 is recessed toward the proximal end. The constricted portion 35 is disposed on the inner side of the anchoring portion 33 , and is formed by the proximal end of the anchoring portion 33 bent and extended toward the direction of the connecting portion 31 , and the constricted portion 35 is disposed around the connecting portion 31 .

In this way, there is no binding force between adjacent membranes 50, which reduces the pulling and binding of the membranes 50 to the anchoring structure 30 in the radial direction, which is beneficial to reduce the contribution of the membranes 50 to the radial supporting force of the anchoring structure 30. When the left atrial appendage occluder 100 is in contact with the left atrial appendage cavity wall in the heart, the damage to the left atrial appendage cavity wall in the heart caused by the excessive radial support force of the anchoring structure 30 caused by the membrane 50 is greatly reduced. Secondly, since the three gaps 51 communicate with each other at the central axis of the opening 36 , it is beneficial to make the forces between the three areas of the anchoring portion 33 covered by the three films 50 more uniform. Finally, when the left atrial appendage occluder 100 is implanted into the left atrial appendage cavity 34, the membrane 50 is located between the anchoring part 33 and the left atrial appendage cavity wall, which greatly increases the distance between the anchoring part 33 and the left atrial appendage cavity wall. Contact area, the force of the left atrial appendage cavity wall is more uniform, and the force of the left atrial appendage cavity wall per unit area is smaller, so as to avoid the damage to the human body caused by the local excessive force of the left atrial appendage cavity wall.

In this embodiment, please refer to FIG. 4 , each piece of film 50 includes three connection points, and the film 50 is fixedly connected to one of the anchor portion 33 or the connection portion 31 at the connection points. Specifically, the connection points include a first connection point 52 , a second connection point 53 and a third connection point 55 , the cover film is fixedly connected to the connection part 31 at the first connection point 52 , and the cover film 50 is connected to the second connection point 53 and the connection part 31 . The third connection point 55 is fixedly connected to the anchor portion 33 . The first connection point 52 , the second connection point 53 and the third connection point 55 are all arranged near the edge of the cover film 50 , wherein the first connection point 52 is arranged in the middle of the cover film 50 near the opening 36 (as shown in FIG. 3 ). The edge of the axis, the second connection point 53 and the third connection point 55 are disposed at the edge of the proximal end of the covering film 50 .

It can be understood that the number of the covering films 50 is not limited, as long as the number of covering films 50 is at least two, and two adjacent covering films 50 may be arranged at intervals and cover the surfaces of different areas on the anchoring structure 30 .

It can be understood that the anchoring structure 30 is not limited to include the constricted portion 35, and in the modified embodiment, the constricted portion 35 may be omitted.

It can be understood that the distal end of the connecting portion 31 is not limited to be funnel-shaped and surround the opening 36. In a modified embodiment, the connecting portion 31 can also be formed from one end of the sealing disc 10 along the axial direction of the anchoring portion 33 from the proximal end to the The distal end extends to form a plane, that is, the distal end of the connecting portion 31 does not enclose an opening 36 .

It can be understood that the various components in the anchoring structure 30 and the connection relationship between the various components are not limited. In one embodiment, the anchoring structure 30 is in the shape of a closed cage, and a plurality of films 50 are disposed on the surface of the anchoring structure 30 .

It can be understood that it is not limited that both the connecting portion 31 and the anchoring portion 33 are covered by the film 50 , and it is within the protection scope of the present application that the film 50 covers at least one of the connecting portion 31 and the anchoring portion 33 .

It can be understood that the cover film 50 is not limited to cover the outside of the connecting portion 31 and the anchor portion 33. In the modified embodiment, at least one piece of cover film 50 covers the outside of the anchor structure 30, and/or at least one piece of cover film 50 covers the inner side of the anchoring structure 30 . For example, in a modified embodiment, the coating 50 covers the inner side of the connection portion 31 and the inner side of the anchor portion 33 . In yet another modified embodiment, one surface of at least one of the inner side and outer side of the connecting portion 31 and the inner side and the outer side of the anchor portion 33 is covered with the coating film 50 .

It can be understood that the arrangement of the multiple films 50 is not limited. For example, in a modified embodiment, a plurality of films 50 may be arranged along the axial direction of the anchoring portion 33, but not limited thereto.

It can be understood that each piece of film 50 is not limited to cover both the connecting portion 31 and the anchoring portion 33 . For example, in the modified embodiment, one of the covering films 50 can be only covered on the anchoring portion 33 , but not limited to. For another example, in yet another modified embodiment, one of the covering films 50 may only cover the connecting portion 31 , but not limited to.

It can be understood that the number and position of the first connection point 52 , the second connection point 53 and the third connection point 55 are not limited.

It can be understood that the specific manner in which the film 50 is fixedly connected to the anchor portion 33 at the first connection point 52 , the second connection point 53 and the third connection point 55 is not limited. The covering film 50 is sewn on the anchoring part 33 or the connecting part 31 , and the covering film 50 may also be adhered to the anchoring part 33 or the connecting part 31 by, but not limited to, medical glue.

It can be understood that the portion of the covering film 50 located in the opening 36 is not limited to be recessed toward the proximal end, that is, the covering film 50 can also cover the opening 36 flatly or protrude toward the distal end, but not limited to.

It can be understood that the number of gaps 51 is not limited. It can be understood that there is no limitation that the plurality of gaps 51 formed between the multiple films 50 are all communicated at the opening 36 . It can be understood that, in the modified embodiment, the plurality of gaps 51 formed between the plurality of films 50 may not communicate with each other. It can be understood that the positions where the plurality of gaps 51 are connected are not limited, and the positions where the plurality of gaps 51 communicate can also be deviated from the central axis of the opening 36 , that is, there is no binding force between at least part of two adjacent films 50 . For example, in a modified embodiment, the plurality of gaps 51 may be communicated at the anchor portion 33 , but not limited to.

In one embodiment, the coating 50 has at least one opening (not shown). The ratio of the sum of the area of the openings to the area of the covering film is the porosity of the covering film 50. By setting the opening ratio and/or the pore size of the openings, the covering film 50 can pass blood flow and block the passage of thrombus. Therefore, the coating film 50 has a certain permeation function.

It can be understood that the membrane 50 is not limited to have at least one opening. For example, in one embodiment, the membrane 50 may not include an opening, that is, the membrane 50 can also, but is not limited to, neither allow thrombus to pass through nor A blocking membrane that allows blood flow to pass through.

In one embodiment, an anticoagulant (eg, heparin) is attached to the surface of the film 50 so that the film 50 has antithrombin properties. It can be understood that the surface of the coating film 50 may also, but not be limited to, adhere to compounds with other properties, or the surface of the coating film 50 may also be, but not limited to, not coated with compounds, which is not limited in this application.

In this embodiment, the shape of the coating 50 is not limited, and the coating 50 may be a two-dimensional sieve, a porous membrane, a woven or non-woven mesh, or a similar structure. It can be understood that the material for making the film 50 is not limited, and the film 50 can be made of metal or metal mesh with fine fibers, or can be made of biocompatible materials, such as expanded polytetrafluoroethylene (expanded polytetrafluoroethylene) , ePFTE), polyester, polytetrafluoroethylene (PTFE), silicone, urethane, metal fiber, medical silicone, polyester, or other biocompatible polymers. It can be understood that the cover film 50 may be one layer or multiple layers, wherein when the cover film 50 is made of multiple layers, the flow blocking effect of the cover film 50 can be significantly improved.

Please refer to FIG. 5 , the left atrial appendage occluder 100 further includes a barb 60 fixedly connected to the anchoring portion 33 , the barb 60 includes a barb connecting portion 61 and a barb suspension portion 63 , and the barb connecting portion 61 is fixedly connected to the barb Between the barb suspended portion 63 and the anchor portion 33 , the barb suspended portion 63 extends toward the proximal end. The barb suspended portion 63 is used for piercing the wall of the left atrial appendage to prevent the left atrial appendage occluder 100 from falling off from the left atrial appendage.

The barb connecting portion 61 passes through the covering film 50 , and the barb suspended portion 63 and the anchoring portion 33 are respectively located on both sides of the covering film 50 . Because the barb connecting portion 61 passes through the membrane 50, on the one hand, it is beneficial to fix the membrane 50 and prevent the membrane 50 from falling off the anchoring portion 33; After the cavity wall, the membrane 50 can be located between the anchoring part 33 and the left atrial appendage cavity wall, so as to increase the contact area between the anchoring part 33 and the left atrial appendage cavity wall, and avoid the penetration depth of the barb suspended part 63 being too large. damage to the human body.

The sealing disc 10 includes a disc surface 11 , a waist portion 13 and a sealing film 15 , and the waist portion 13 is fixedly connected to the distal end of the disc surface 11 . The disk surface 11 and the waist 13 are both surrounded by a cavity, and the side close to the cavity is defined as the inner side, and the side away from the cavity is defined as the outer side. In this embodiment, as shown in FIG. 5 , the sealing disc 10 is provided with two sealing films 15 , wherein one sealing film 15 is fixedly connected to the inner side of the disk surface 11 , and the other sealing film 15 is also fixedly connected to the waist 13 inside. Due to the provision of the sealing membrane 15, the sealing performance of the sealing disc 10 is enhanced to prevent the thrombus from entering the left atrial appendage.

It can be understood that the sealing film 15 can also be fixedly connected to the outer side of the disk surface 11, but is not limited to, or, in a modified embodiment, the inner and outer sides of the sealing disk 10 are covered by the sealing film 15, for example, the outer and inner sides of the disk surface 11 Both are covered by the sealing film 15, or both the inner and outer sides of the waist 13 are covered with the sealing film 15, or, the inner side of the disk surface 11 and the outer side of the waist 13 are both covered with the sealing film 15, or, the outer side of the disk surface 11 and the waist The inner side of 13 is covered with sealing film 15 . It can be understood that, in a modified embodiment, the left atrial appendage occluder 100 may only include the sealing membrane 15 provided on the disc surface 11 , or the left atrial appendage occluder 100 may only include the sealing membrane 15 provided on the disc surface 11 . In a modified embodiment, the sealing film 15 can also be fixedly connected to the outer side of the waist portion 13 , or fixed to the outer side of the disk surface 11 , but is not limited to.

In this embodiment, the left atrial appendage occluder 100 is made of braided wire, the braided wire can be made of, but not limited to, nickel-titanium alloy wire, cobalt-based alloy wire, or stainless steel wire and other metal materials, and the braided wire can also be made of high Made of molecular materials. It should be noted that, in the modified embodiment, at least part of the structure of the left atrial appendage occluder 100 can also be cut by laser, but not limited to.

As shown in FIG. 6 , the left atrial appendage occluder 100 provided in this embodiment can be delivered to a selected part of the human body through a percutaneous puncture technique. In this embodiment, the left atrial appendage occluder 100 includes a contracted state and a released state. When the left atrial appendage occluder 100 is in the contracted state, it can be loaded into a delivery device with a smaller diameter, and then punctured into the superior vena cava through the femoral vein. , and then enter the right atrium a, and then enter the left atrium c through the atrial septum b, so as to reach the left atrial appendage d. When the left atrial appendage occluder 100 is released, first, the anchoring structure is released inside the left atrial appendage, and the barbed suspended portion 63 on the anchoring portion 30 penetrates the wall of the left atrial appendage cavity; then the waist portion 13 of the sealing disc 10 is released on the left At the opening position of the left atrial appendage, the disk surface 11 of the sealing disk 10 is released at the opening position of the left atrium, and the opening position of the left atrial appendage is closed. After the release is completed, the left atrial appendage occluder 100 is detached from the connection of the delivery device. At this time, the left atrial appendage occluder 100 is in a released state, and the released state is shown in FIG. 6 .

It can be understood that the manner in which the left atrial appendage occluder 100 enters the left atrial appendage is not limited.

Second Embodiment

Please refer to FIG. 7 , FIG. 8 , FIG. 9 and FIG. 10 , different from the first embodiment, in the second embodiment, when the left atrial appendage occluder 200 is in the released state, the membrane 250 loosely covers the connection On the anchor portion 231 and the anchor portion 233 , that is, in the first direction along the anchor portion 233 , the full length of each film 250 is greater than the extended length of the anchor portion 233 covered by the film 250 . In this embodiment, the first direction is the circumferential direction and the axial direction of the anchor portion 233 .

It can be understood that, not limited to the axial and circumferential directions of the anchoring portion 233, the full length of the film 250 is greater than the extended length of the area covered by the film 250 in the anchoring portion 233. In the modified embodiment, the The first direction is the axial direction, the circumferential direction or other directions of the anchoring portion 233 .

Specifically, as shown in FIG. 9 , the cover film 250 includes a first position point and a second position point, and the full length of the cover film 250 between the first position point and the second position point is the cover film 250 at the first position. The length of the section between the point and the second position point when the tile is unfolded. The extension distance between the connecting portion 231 and the anchoring portion 233 between the first position point and the second position point is the distance between the connecting portion 231 and the anchoring portion 233 between the first position point and the second position point along the connecting portion 231 and the second position point. The length that the surface of the anchor portion 233 extends. In the first direction, the full length of the film 250 between the first position point and the second position point is greater than the extension distance of the connecting portion 231 and the anchor portion 233 between the first position point and the second position point . For example, the first position point may be the connection position of the cover film 250 and the connecting portion 231 , that is, the first position point may be the first connection point 252 . The second position point may be the connection position of the film 250 and the anchoring portion 233 , that is, the second position point may be one of the second connection point 253 and the third connection point 255 . For another example, the first position point and the second position point may both be the connection positions of the film 250 and the anchoring portion 233 , that is, the first position point is one of the second connection point 253 and the third connection point 255 , and the first position point is one of the second connection point 253 and the third connection point 255 . The second point is the other of the second connection point 253 and the third connection point 255 . It can be understood that the above-mentioned first position point and second position point may be other position points on the coating film 250 other than the first connection point 252 , the second connection point 253 and the third connection point 255 .

When the left atrial appendage occluder 200 is implanted into the left atrial appendage cavity 234, when the membrane 250 is squeezed by the wall of the left atrial appendage cavity, the anchoring structure 230 is deformed by force. When the deformation amount of the anchoring structure 230 between them is within a certain range, since the film 250 between the first position point and the second position point loosely covers the connecting part 231 and the anchoring part 233, the first position The film 250 between the point and the second point will not pull and bind the anchoring structure 230, and provide a certain deformation space for the anchoring structure 230 in the first direction. The contribution of the radial support force is small, which is beneficial to avoid the loss of the left atrial appendage cavity wall due to the excessive radial support force of the anchoring portion 233 due to the restraint of the membrane 250, and is beneficial to the anchoring portion 233 to better fit on the left atrial appendage cavity wall. Atrial appendage wall.

It can be understood that the covering film 250 is not limited to cover the outer side of the anchoring portion 233 and the outer side of the connecting portion 231. In the modified embodiment, the covering film 250 can also cover the inner side of the anchoring portion 233 and the outer side of the connecting portion 231, but not limited to. inside. In this way, since the membrane 250 covers the side of the anchoring portion 233 close to the cavity 234 and the side of the connecting portion 231 close to the cavity 234, when the left atrial appendage occluder 200 is implanted into the left atrial appendage cavity 234, The left atrial appendage cavity wall is in direct contact with the anchoring portion 233 to prevent the membrane 250 from contacting the left atrial appendage cavity wall. The radial support force is too large to cause damage to the human body.

Third Embodiment

11 to FIG. 15 , compared with the second embodiment, the membrane 350 of the left atrial appendage occluder 300 provided by the third embodiment is folded. Specifically, as shown in FIG. 15 , the anchoring structure 330 The surface includes a first area 336 and a second area 337 located in different ranges in at least one of the first directions. Each film 350 is provided with a number of raised areas 357 and recessed areas 359, and the raised areas 357 cover the first area correspondingly. In an area 336, the recessed area 359 covers the second area 337 correspondingly, and the gap d1 between the film 350 in the raised area 357 and the first area 336 is larger than that between the film 350 in the recessed area 359 and the second area 337 the gap d2. In this embodiment, the first direction is the circumferential direction and the axial direction of the anchoring structure 330 , and the convex area 357 and the concave area 359 are disposed in different ranges in the circumferential direction in the first direction.

In a modified embodiment, the first direction is the circumferential direction and the axial direction of the anchoring structure 330 , the convex area 357 and the concave area 359 are arranged in different ranges in the axial direction in the first direction, or the convex area The regions 357 and the recessed regions 359 are disposed in different ranges in the axial direction and the circumferential direction in the first direction, so that the protruding regions 357 and the recessed regions 359 are arranged in a matrix.

It can be understood that, in the modified embodiment, the first direction may also be, but not limited to, the axial direction, the circumferential direction or other directions of the anchoring structure 330 .

In this way, since the cover film 350 includes several convex regions 357 and recessed regions 359 , the deformation space of the cover film 350 can be increased, and the stretchable range of the cover film 350 can be increased. When the left atrial appendage occluder 300 is implanted into the left atrial appendage cavity 334, even if it is squeezed by the wall of the left atrial appendage, the membrane 350 is not easy to involve the anchoring structure 330, so as to avoid excessive radial support force of the anchoring structure 330. Large damage to the left atrial appendage cavity wall to avoid damage to the human body.

In this embodiment, the number of the raised areas 357 and the recessed areas 359 is several, and the raised areas 357 and the recessed areas 359 are alternately arranged in the circumferential direction of the anchoring structure 330, so that the recessed areas 359 are located adjacent to the raised areas. between zone 357. Both the convex area 357 and the concave area 359 of the coating 350 located at the anchoring part 333 extend along the axial direction of the anchoring part 333 , and the convex area 357 and the concave area 359 of the coating 350 located at the connecting part 331 are both along the anchoring part 331 . radial extension of portion 333 .

It can be understood that the number of raised areas 357 and recessed areas 359 is not limited. It can be understood that the extending direction of the convex area 357 and the concave area 359 is not limited, and in a modified embodiment, the convex area 357 and/or the concave area 359 may also extend in an oblique, spiral or other curved direction.

It can be understood that it is not limited that each film 350 is provided with a convex area 357 and a concave area 359, and the condition that one or more films 350 are provided with the convex area 357 and the concave area 359 are all within the protection of this application. within the range.

In this embodiment, the protrusions of the cover film 350 in the convex area 357 and the grooves of the cover film 350 in the concave area 359 are generated during the process of fixing the cover film 350 to the anchoring structure 330 . The membrane 350 includes a concave connection point (not shown) disposed in the concave area 359, and the cover film 350 is fixedly connected to the anchoring structure 330 at the concave connection point. The covering film 350 is flat and wrinkle-free before being fixed to the anchoring structure 330. During the process of fixing the covering film 350 to the anchoring structure 330, the length of the covering film 350 between adjacent concave connection points is greater than that of the adjacent concave concave connection points. The shortest distance between the groove connection points, and make the film 350 protrude in the raised area 357 toward the side facing away from the anchoring structure 330 to form a protrusion, so that the film 350 in the raised area 357 is connected to the first area 336 The gap between them is larger than the gap between the cover film 350 in the recessed region 359 and the second region 337 .

It can be understood that there is no limit to the formation of wrinkles in the film 350 during the process of being fixed to the anchoring structure 330. For example, but not limited to, a method of heating and setting a mold can be used to generate multiple wrinkles on the film 350. The covering film 350 is fixed to the surface of the anchoring structure 330, which is beneficial to reduce the number of connection points between the covering film 350 and the anchoring structure.

Fourth Embodiment

16 and FIG. 17 , the left atrial appendage occluder 400 provided by the fourth embodiment of the present application includes a sealing disc 410 , an anchoring structure 430 and a membrane 450 , and the sealing disc 410 is fixedly connected to the anchoring structure 430 . The cover 450 is fixedly connected to at least part of the anchoring structure 430 .

The anchoring structure 430 includes a connecting portion 431, an anchoring portion 433 and a constricted portion 435. The connecting portion 431 is connected between the anchoring portion 433 and the sealing disc 410. The connecting portion 431 is formed by extending from one end of the sealing disc 410 to the distal end. The distal end of the portion 431 is funnel-shaped and surrounds an opening 436, which faces the distal end. The anchoring portion 433 is formed by bending and extending from the distal end of the connecting portion 431 toward the proximal end. The anchoring portion 33 is cylindrical, and the anchoring portion 33 is spaced from the sealing disc 10 . The connecting portion 431 is accommodated in the anchoring portion 433 to anchor The portion 433 and the connecting portion 431 together form a cavity 434 . The side of the connection portion 431 and the anchor portion 433 facing the cavity 434 is the inner side, and the side of the connection portion 431 and the anchor portion 433 away from the cavity 434 is the outer side. The constricted portion 435 is formed by bending and extending from the proximal end of the anchoring portion 333 toward the connecting portion 431 , and the constricted portion 435 is disposed inside the cavity 434 around the connecting portion 431 .

Please refer to FIG. 17 , FIG. 18 and FIG. 19 , in this embodiment, the number of the covering films 450 is two, and the covering films 450 include the first covering film 453 and the second covering film 452 , the first covering film 453 and the second covering film 450 . The number of the covering films 452 is one piece, the first covering film 453 is fixedly arranged on the outer side of the anchoring portion 433 , the second covering film 452 is fixedly arranged at the outer side of the connecting portion 431 and covers at least part of the opening 436 , and the second covering film 452 is located at the outer side of the connecting portion 431 . Portions of opening 436 are recessed proximally. In this embodiment, the second coating film 452 is circular, and the first coating film 453 is cylindrical and disposed around the second coating film 452 . A gap 451 is formed between the second coating 452 and the first coating 453 , the gap 451 extends along the circumferential direction of the anchoring portion 433 , and the gap 451 is annular. In this way, the second film 452 and the first film 453 will not be pulled each other. When the left atrial appendage occluder 400 is released into the left atrial appendage cavity, when the first film 453 is pressed by the left atrial appendage cavity wall, the The damage to the human body caused by the excessive radial support force of the left atrial appendage occluder 400 caused by the membrane 450 can be avoided.

It will be appreciated that the shape of the opening 436 is not limited. It can be understood that the opening 436 may also be omitted in modified embodiments.

It can be understood that the anchoring structure 430 is not limited to include the constricted portion 435, for example, in the modified embodiment, the constricted portion 435 can also be omitted.

It can be understood that the number of the covering films 450 is not limited, as long as the number of covering films 450 is greater than or equal to two pieces.

It can be understood that the shapes of the second coating 452 and the first coating 453 are not limited. It can be understood that the shape of the gap 451 formed by the second coating 452 and the first coating 453 is not limited.

In this embodiment, the second coating 450 and the first coating 450 are provided with several connection points at least at the edges, and both the second coating 452 and the first coating 453 are fixedly connected to the anchoring portion 433 at the connection points. In this way, the second coating film 452 and the first coating film 453 are less likely to come off.

It can be understood that it is not limited that the connection points on the second coating film 452 and the first coating film 453 are arranged close to the edge.

It can be understood that the second covering film 452 is not limited to be fixed on the distal end of the connecting portion 431 and cover at least part of the opening 436 , and the first covering film 453 is disposed outside the anchoring portion 433 . For example, in the modified embodiment, the second coating 452 may be fixed to the inner side of the connecting portion 431 , and the second coating 452 and the opening 436 may be located on both sides of the connecting portion 431 , respectively. In yet another modified embodiment, the first covering film 453 may be, but is not limited to, disposed on the inner side of the anchoring portion 433 .

It can be understood that the portion of the second coating film 452 located at the opening 436 is not limited to be recessed toward the side where the sealing disc 410 is located.

It can be understood that the number of the first covering films 453 is not limited. For example, in the modified embodiment, the number of the first covering films 453 is multiple, and a plurality of the first covering films 453 are arranged at intervals along the axial direction of the anchoring portion 433 , and multiple gaps are formed.

It can be understood that the number of the second coating films 452 is not limited. For example, in a modified embodiment, the number of the second coating films 452 is multiple, and a plurality of the second coating films 452 are arranged in concentric circles covering the connecting portion 431 .

Fifth Embodiment

Please refer to FIG. 20 , FIG. 21 and FIG. 22 , compared with the fourth embodiment, the difference is that in this embodiment, when the left atrial appendage occluder 500 is in the released state, the first covering film 553 loosely covers the The anchoring portion 533 and the second coating 552 loosely cover the opening 536 . Specifically, in the first direction along the anchoring portion 533 , the full length of the first covering film 553 is greater than the extended length of the area in the anchoring portion 533 covered by the first covering film 553 . In the circumferential and radial directions of the connecting portion 531 , the full length of the second coating film 552 is greater than the extended length of the region of the connecting portion 531 covered by the second coating film 552 . In this embodiment, the first direction includes at least the circumferential direction of the anchor portion 533 .

It can be understood that, in the modified embodiment, the first direction may also be, but not limited to, the axial direction of the anchoring portion 533 , or the first direction may be the axial and circumferential directions of the anchoring portion 533 , or the first direction Including other directions than the circumferential and axial directions.

In this embodiment, since the first film 553 also loosely covers the anchoring portion 533, and the second film 552 loosely covers the opening 536, when the second film 552 and the first film 553 are exposed to the left atrial appendage cavity When the wall is squeezed, the pulling force of the second coating 552 to the connecting part 531 and the pulling force of the first coating 553 to the anchoring part 533 are reduced, and the second coating 552 and the first coating 553 to the anchoring part are reduced. The contribution of the radial support force of the anchoring portion 533 can prevent damage to the human body due to the excessive radial support force of the anchoring portion 533 due to the restraint of the film 550 .

It can be understood that the first coating 553 is not limited to be provided on the outside of the anchoring portion 533 , for example, in a modified embodiment, the first coating 553 may be provided on the inner side of the anchoring portion 533 , but not limited to. It can be understood that the second coating film 552 is not limited to be fixed to the outer side of the connecting portion 531 and cover at least part of the opening 536 . In yet another modified embodiment, the second coating film 552 may be fixed on the inner side of the connecting portion 531 but not limited to, that is, the second coating film 552 and the opening 536 are located on both sides of the connecting portion 531, respectively.

Sixth Embodiment

Please refer to FIG. 23 , FIG. 24 and FIG. 25 , compared with the fifth embodiment, the difference is that in this embodiment, both the first covering film 653 and the second covering film 652 are provided with wrinkles. Specifically, the surface of the anchoring portion 633 includes a first region and a second region located in different ranges in at least one of the first directions, and the first coating 653 is provided with a first convex region 6531 and a first concave region 6533. The first convex area corresponds to covering the first area, the first concave area 6533 corresponds to covering the second area, and the gap between the first coating 653 and the first area in the first convex area 6531 is larger than that in the first concave area the gap between the first coating 653 and the second region. In the present embodiment, the first region and the second region are provided in different ranges in the circumferential direction in the first direction on the surface of the anchor portion 633 .

It can be understood that, in the modified embodiment, the first area and the second area are arranged in different ranges in the axial direction in the first direction on the surface of the anchor portion 633, or, the first area and the second area are arranged at the anchor portion 633. The surface of the fixed portion 633 is in different ranges in the circumferential direction and the axial direction in the first direction. In a modified embodiment, the first direction includes directions other than the circumferential direction and the axial direction.

The surface of the connecting portion 631 includes a third region and a fourth region located in different circumferential ranges, and the second film 652 is provided with a second convex region 6521 and a second concave region 6523 . The second raised area 6521 corresponds to covering the third area, the second recessed area 6523 corresponds to covering the fourth area, and the gap between the second coating 652 and the third area in the second raised area 6521 is larger than the second recessed area The gap between the second coating 652 in 6523 and the fourth region.

It can be understood that, in the modified embodiment, the third area and the fourth area are disposed in different ranges in other directions of the anchoring portion 633, so as to provide deformation space for the anchoring structure in this direction.

In this way, the stretchable range of the second membrane 652 and the first membrane 653 is increased, and when the left atrial appendage occluder 600 is implanted into the left atrial appendage cavity 634, the second membrane 652 and the first membrane 653 Even if it is squeezed by the wall of the left atrial appendage, the contribution of the second membrane 652 and the first membrane 653 to the radial support force of the anchoring portion 633 is greatly reduced, and the radial support of the anchoring portion 633 is prevented from being damaged too much. human body and reduce the threat to human health.

In this embodiment, the first raised region 6531 extends along the axial direction of the anchor portion 633 . A first recessed region 6533 extending along the axial direction of the anchor portion 633 is formed between the adjacent first raised regions 6531 . The adjacent first convex regions 6531 and the first concave regions 6533 are arranged along the circumferential direction of the anchoring portion 633 .

In this embodiment, the second raised regions 6521 extend along the radial direction of the connecting portion 631 , and a second recessed region 6523 extending along the radial direction of the connecting portion 631 is formed between adjacent second raised regions 6521 . The plurality of second convex regions 6521 and the second concave regions 6523 are radially arranged.

It can be understood that the extending directions of the first raised area 6531 and the second raised area 6521 are not limited. For example, the extending direction of the first raised regions 6531 may also be, but not limited to, inclined relative to the axial direction of the anchor portion 633 , so that several first raised regions 6531 are arranged in a spiral along the circumferential direction of the anchor portion 633 . For example, the extension path of the second raised region 6521 may also extend along the circumferential direction of the anchoring portion 633 but is not limited to.

It can be understood that, in the modified embodiment, the first covering film 653 can also, but is not limited to, cover the inner side of the anchoring portion 633, and the second covering film 652 can also, but is not limited to, cover the inner side of the connecting portion 631, so that the second covering film 652 can also cover the inner side of the connecting portion 631 but is not limited to The membrane 652 and the opening 636 are located on both sides of the connecting portion 631 respectively.

In a modified embodiment, the first cover film 653 or the second cover film 652 is provided with pleats as described above.

Seventh Embodiment

Please refer to FIGS. 26 , 27 , 28 and 29 in conjunction with FIG. 26 , FIG. 27 , FIG. 28 , and FIG. 29 , different from the first embodiment, in this embodiment, the left atrial appendage occluder 700 includes a plurality of covering films 750 , and the plurality of covering films 750 cover the The inner side of the anchoring portion 733 and the inner side of the connecting portion 731 , at this time, the coating 750 and the opening 736 are respectively located on both sides of the connecting portion 731 . In this way, since the membrane 750 covers the inner side of the anchoring portion 733 and the inner side of the connecting portion 731, and is connected to the anchoring portion 733 through several connection points, when the LAA occluder 700 is implanted into the LAA cavity, The left atrial appendage cavity wall is in direct contact with the anchoring portion 733 to prevent the membrane 750 from contacting the left atrial appendage cavity wall. The extrusion of the anchor portion 733 further produces a binding force or a pulling force on the anchor portion 733 , so as to avoid damage to the human body due to the excessive radial support force of the anchor portion 733 caused by the film 750 .

It should be noted that, without departing from the spirit of the present invention, the specific technical solutions in the above embodiments may be mutually applicable. What is disclosed above is only the preferred embodiment of the present application, and of course it cannot limit the scope of the right of the present application. Therefore, the equivalent changes made according to the claims of the present application are still within the scope of the present application.

Claims

A left atrial appendage occluder, characterized in that it comprises a sealing disc, an anchoring structure and at least two films, the sealing disc and the anchoring structure are fixedly connected, the at least two films are arranged at intervals, and Surfaces covering different areas of the anchoring structure.
The left atrial appendage occluder according to claim 1, wherein the anchoring structure comprises a connecting part and an anchoring part, the connecting part is connected between the anchoring part and the sealing disc, and is formed by extending from one end of the sealing disc to the distal end, the anchoring portion is formed by bending and extending from the distal end of the connecting portion toward the proximal end, the connecting portion is accommodated in the anchoring portion, and the anchoring portion A cavity is formed together with the connecting portion, and the at least two films cover at least one of the connecting portion and the anchoring portion.
The left atrial appendage occluder according to claim 2, wherein the distal end of the connecting portion is funnel-shaped and surrounds an opening, and at least part of the connecting portion is located between the cavity and the opening. between.
The left atrial appendage occluder according to claim 3, wherein at least part of the membrane covers the opening, and the part of the membrane located at the opening is concave toward the proximal end.
The left atrial appendage occluder according to claim 2, wherein the side of the anchoring structure facing the cavity is the inner side, and the side of the anchoring structure facing away from the cavity is the outer side, at least One piece of the film covers the outside of the anchoring structure, and/or at least one piece of the film covers the inside of the anchoring structure.
The left atrial appendage occluder according to claim 5, wherein at least one piece of the membrane covers the anchoring part, and at least one piece of the membrane covers the connecting part and is located in the anchoring part A gap is formed between the coating and the coating located at the connecting portion.
The left atrial appendage occluder according to claim 6, wherein the gap is annular.
The left atrial appendage occluder according to claim 5, wherein at least two sheets of the membrane are arranged along the circumferential direction of the anchoring portion and cover the anchoring portion.
The left atrial appendage occluder according to claim 8, wherein a gap is formed between the adjacent membranes, and the part of the gap at the anchor portion extends along the axial direction of the anchor portion.
The left atrial appendage occluder according to claim 8, characterized in that, at least part of the at least two films also covers the connecting portion.
The left atrial appendage occluder according to claim 10, wherein the portion of the gap located at the connecting portion extends along the radial direction of the connecting portion, and the gap between the at least two membranes connected at the opening.
The left atrial appendage occluder according to claim 10, wherein at least one piece of the film comprises a first connection point, a second connection point and a third connection point, and the film is at the first connection point The cover is fixedly connected to the connecting portion at the second connecting point and the third connecting point is fixedly connected to the anchoring portion.
The left atrial appendage occluder according to any one of claims 6 or 8, wherein in the first direction along the anchoring structure, the full length of at least one of the membranes is greater than the anchoring The extended length of the area covered by the film in the part.
The left atrial appendage occluder according to claim 13, wherein the surface of the anchoring structure comprises a first area and a second area located in different ranges in at least one of the first directions, and at least one of the membranes A convex area and a concave area are provided, the convex area correspondingly covers the first area, the concave area correspondingly covers the second area, and the gap between the coating film in the convex area and the first area is The gap is larger than the gap between the coating film in the recessed area and the second area.
The left atrial appendage occluder according to claim 13, wherein the first direction is the circumferential direction and/or the axial direction of the anchoring portion.
The left atrial appendage occluder according to claim 2, further comprising a barb fixedly connected to the anchoring portion, the barb comprising a barb connecting portion and a barb suspension portion, the barb The connecting portion is fixedly connected between the barb suspended portion and the anchor portion, and the barb suspended portion extends toward the side where the sealing disc is located.
The left atrial appendage occluder according to claim 16, wherein at least part of the covering film covers the outer side of the anchoring part, the barb connecting part passes through the covering film, and the inverted The thorn suspended part and the anchoring part are respectively located on two sides of the covering film.
The left atrial appendage occluder according to claim 1, further comprising a sealing film covering the sealing disc.