WO2018166378A1

WO2018166378A1 - Left auricle occluder

Info

Publication number: WO2018166378A1
Application number: PCT/CN2018/078148
Authority: WO
Inventors: 刘云奇; 殷胜利; 郭少成; 余聪阈; 杨习锋; 曾晨光; 张希
Original assignee: 广州新诚生物科技有限公司
Priority date: 2017-03-17
Filing date: 2018-03-06
Publication date: 2018-09-20
Also published as: CN207785227U

Abstract

A left auricle occluder (1), comprising a stent front end (11), a stent rear end (12), a support (13), and a stent membrane (14). The stent front end (11) and the stent rear end (12) are connected by means of the support (13); the stent membrane (14) covers on the surfaces of the stent front end (11) and the stent rear end (12); the stent front end (11) and the stent rear end (12) can be compressed and deformed; the left auricle occluder (1) is mounted into the left auricle (2), and then the stent front end (11) and the stent rear end (12) are restored to the original shapes; an angle of 5-30° is included between the stent front end (11) and the stent rear end (12); the lantern-shaped memory alloy of the stent front end (11) regains its shape and is fixed to the inner wall of the left auricle (2); as the removal of a delivery sheath, the umbrella-shaped memory alloy of the stent rear end (12) regains its shape and is in close contact with the ostium of the left auricle, to effectively prevent the occluder (1) from further entering the inner cavity of the left auricle (2) or falling off; the stent membrane (14) can effectively prevent blood clots from being omitted; since there is no barb structure on the surface of the stent membrane (14), the position of the occluder (1) can be adjusted in the left auricle (2) with different structures, so that the complexity of an operation is reduced.

Description

Left atrial appendage occluder

Technical field

The utility model belongs to the field of cardiac medical instruments, in particular to a left atrial appendage occluder.

Background technique

Atrial fibrillation (AF) is the most common type of arrhythmia in the clinic. The total incidence rate is as high as 0.77%. With the increase of age, the incidence rate is increasing, and the population over 75 years old can reach 10%. The main hazard of atrial fibrillation is the left atrial thrombosis, which induces acute myocardial infarction stroke, peripheral vascular embolization and other complications, and increases disability and mortality. At present, more than 90% of the thrombus in patients with non-valvular atrial fibrillation comes from the left atrial appendage, so closing or sealing the left atrial appendage can significantly reduce thrombosis and reduce thromboembolic complications. Traditional treatment options include oral anticoagulant drugs, radiofrequency ablation of atrial fibrillation and left atrial appendage ligation, but oral anticoagulant drugs are expensive, which may lead to bleeding complications and poor patient compliance with long-term medication; radiofrequency ablation of atrial fibrillation The wound is large, the cost is high, and it is easy to relapse. The left atrial appendage requires thoracotomy and the wound is large. There are deficiencies in the above treatment options.

The minimally invasive left atrial appendage occlusion that has arisen in recent years avoids the shortcomings of the above-mentioned extracorporeal circulation surgery. However, due to the different anatomical shapes of the left atrial appendage, and the design principles and structural defects of the existing occluder, on the one hand, it is easy to cause blood residual during and after operation, and the ideal sealing effect is not achieved; on the other hand, Because the occluder is not firmly fixed, it is prone to shedding, which increases the complexity during or after surgery.

Utility model content

The purpose of the utility model is to overcome the deficiencies of the prior art, and to provide a left atrial appendage occluder, which ensures the firm fixation of the occluder in the left atrial appendage and effectively prevents the leakage of the thrombus.

In order to achieve the above object, the technical solution adopted by the utility model is as follows: a left atrial appendage occluder includes a front end of the bracket, a rear end of the bracket, a support frame and a bracket film, and the front end of the bracket and the rear end of the bracket pass through the support frame Connecting, the bracket film covers the front end of the bracket and the rear end surface of the bracket; the front end of the bracket and the rear end of the bracket are compressively deformable, and the front end of the bracket and the rear end of the bracket are shaped, behind the front end of the bracket and behind the bracket There is an angle between the ends, and the angle ranges from 5° to 30°.

Preferably, the front end of the bracket and the rear end of the bracket are mesh structures woven from a memory alloy.

Preferably, the compressed front end of the bracket is a cylindrical net body structure, and the compressed rear end of the bracket is a cone net structure.

Preferably, the stent film is a biofilm with a thickness of 0.25 to 0.35 mm.

Preferably, the compressed occluder is delivered to the left atrial appendage by a delivery device, and the occluder begins to recover shape after entering the left atrial appendage, and the front end of the stent is restored in shape to a lantern-shaped structure, and the stent is After the shape is restored, the shape is an umbrella structure.

Preferably, the lantern-shaped structure is a mesh structure that intersects each other, and the umbrella-shaped structure is a uniformly distributed semi-elliptical structure, and the number of the semi-elliptical structures is 30-40.

Preferably, the longitudinal structure of the mushroom structure and the lantern-shaped structure is circular, and the maximum diameter of the longitudinal section of the mushroom structure is larger than the maximum diameter of the longitudinal section of the lantern-shaped structure.

Preferably, the longitudinal cross-sectional diameter of the lantern-shaped structure first increases from the left atrial appendage to the left atrial appendage and then decreases.

Preferably, the compressed occluder moves the adjustment position back and forth in the left atrial appendage.

Preferably, the front end of the bracket after the restored shape is fixedly attached to the inner wall of the left atrial appendage, and the rear end of the bracket after the restored shape is fixed and closed at the left atrial appendage.

The utility model has the beneficial effects that the occluder of the utility model adopts a two-stage memory alloy bracket, and after the occluder is installed in the left atrial appendage, the front end of the stent and the rear end of the stent recover the shape and have an angle of 5°-30°. With the extraction of the delivery sheath, the front end of the stent-shaped memory alloy recovers its shape and is fixedly attached to the inner wall of the left atrial appendage. The umbrella-shaped memory alloy at the rear end of the stent recovers and is in close contact with the left atrial appendage, effectively preventing the occluder from continuing to enter the left. The inner ear cavity and the falling off; because the front end of the stent and the rear end surface of the stent are covered with the stent film, the thrombus leakage can be more effectively prevented; since the surface of the stent film has no barb structure, the occluder installation can be appropriately adjusted during the installation process of the occluder The position can be adjusted to a suitable position in the left atrial appendage of different configurations to reduce the complexity of the operation.

DRAWINGS

Figure 1 is a schematic view showing the structure of the left atrial appendage occluder without the stent film;

2 is a schematic structural view of the left atrial appendage occluder covering the stent film according to the present invention;

Figure 3 is a schematic view showing the structure of the left atrial appendage occlusion device in a compressed state before entering the left atrial appendage;

Figure 4 is a schematic view showing the structure of the front end of the stent after the left atrial appendage occlusion device enters the left atrial appendage;

Fig. 5 is a schematic view showing the structure of the memory alloy stent completely restored after the left atrial appendage occlusion device enters the left atrial appendage.

detailed description

The specific embodiments of the present invention are further described below in conjunction with the accompanying drawings:

To achieve the above object, the technical solution adopted by the present invention is as follows: As shown in FIGS. 1 and 2, the left atrial appendage occluder 1 includes a stent front end 11 and a stent rear end 12, a support frame 13 and a stent film 14, and a stent front end 11 and The bracket rear end 12 is coupled by a support frame 13 that covers the surface of the bracket front end 11 and the bracket rear end 12. The front end 11 of the bracket and the rear end 12 of the bracket are mesh structures woven from a memory alloy, and the memory alloy bracket is compressible and deformable.

As shown in Figure 3-5, the left atrial appendage occluder 1 can be stretched and compressed along the axial direction. The compressed stent front end 11 is a cylindrical mesh structure, and the compressed stent rear end 12 is a cone mesh body. structure. The compressed left atrial appendage occluder 1 is connected to the delivery device, and the left atrial appendage occluder 1 is delivered into the lumen of the left atrial appendage 2 through the delivery sheath. Both the front end of the stent and the rear end surface of the stent are covered with a stent film to prevent the leakage of blood vessels more effectively.

In the utility model, the stent film 14 is a biofilm with a thickness of 0.25-0.35 mm, and the stent film 14 covers the compressed stent front end 11 and the stent rear end 12 surface, and the compressed left atrial appendage occlusion device 1 enters the left atrial appendage 2 After the inner cavity begins to gradually recover the trait, the biofilm can expand with the recovery deformation of the front end 11 of the stent and the rear end 12 of the stent, so that it closely covers the surface of the memory alloy stent.

The front end 11 of the bracket is placed in the inner cavity of the left atrial appendage 2, and the restored shape of the front end 11 of the bracket is a lantern-shaped structure, and the lantern-shaped structure is a mesh structure that crosses each other. The restored front end 11 of the bracket is fixed and closely attached thereto. The inner wall of the left atrial appendage 2 has the effect of blocking the front end 11 of the stent to block the left atrial appendage 2; the rear end 12 of the stent is placed at the left atrial appendage 2, and the restored shape of the rear end 12 of the stent is an umbrella structure, and the umbrella structure is an evenly distributed half. The number of elliptical structures and semi-elliptical structures is 30-40, and the rear end 12 of the stent after the restored shape is fixed and closed at the mouth of the left atrial appendage, effectively preventing the left atrial appendage occluder 1 from continuing into the lumen of the left atrial appendage 2 and falling off. . Since the surface of the stent film 14 has no barb structure, the installation position of the left atrial appendage occluder 1 can be appropriately adjusted during the installation of the left atrial appendage occluder 1, and the left atrial appendage can be adjusted to a suitable position in the left atrial appendage 2 of different configurations. The installation of the plug 1 reduces the complexity of the procedure.

After the left atrial appendage occluder 1 is installed into the left atrial appendage 2, the stent front end 11 and the stent rear end 12 have an angle of 5°-30° after the shape is completely restored, and the angle can be appropriately adjusted according to different configurations of the left atrial appendage 2, so that The left atrial appendage occluder 1 is tightly connected to the left atrial appendage 2 .

The longitudinal section of the rear end 12 of the mushroom-shaped structure bracket and the front end 11 of the lantern-shaped structure bracket are circular, and the longitudinal section diameter of the lantern-shaped structure is increased from the inner cavity of the left atrial appendage 2 to the left atrial appendage 2 The maximum diameter of the longitudinal section of the mushroom structure is smaller than the maximum diameter of the longitudinal section of the lantern structure.

Variations and modifications of the above-described embodiments may also be made by those skilled in the art in light of the above disclosure. Therefore, the present invention is not limited to the specific embodiments disclosed and described herein, and modifications and variations of the invention are intended to fall within the scope of the appended claims. In addition, although the specific terms are used in the specification, these terms are merely for convenience of description and do not constitute any limitation to the present invention.

Claims

A left atrial appendage occluder includes a front end of the bracket, a rear end of the bracket, a support frame and a bracket film, wherein the front end of the bracket and the rear end of the bracket are connected by a support frame, and the bracket film covers the a front end of the bracket and a rear end surface of the bracket; the front end of the bracket and the rear end of the bracket are compressively deformable, and after the front end of the bracket and the rear end of the bracket are shaped, an angle exists between the front end of the bracket and the rear end of the bracket, the clip The angle ranges from 5° to 30°.
A left atrial appendage occluder according to claim 1, wherein the front end of the bracket and the rear end of the bracket are mesh structures woven from a memory alloy.
The left atrial appendage occluder according to claim 1, wherein the compressed front end of the bracket is a tubular net body structure, and the compressed rear end of the bracket is a cone net structure.
A left atrial appendage occluder according to claim 1, wherein the stent film is a biofilm having a thickness of 0.25 to 0.35 mm.
The left atrial appendage occluder according to claim 1, wherein the compressed occluder is delivered to the left atrial appendage by a delivery device, and the occluder begins to recover shape after entering the left atrial appendage. The front end of the bracket is restored in shape and has a lantern-shaped structure, and the rear end of the bracket is restored in shape and has an umbrella structure.
The left atrial appendage occluder according to claim 5, wherein the lantern-shaped structure is a mesh structure that intersects each other, and the mushroom structure is a uniformly distributed semi-elliptical structure, the semi-elliptical structure The number is 30 to 40.
The left atrial appendage occluder according to claim 5, wherein the umbrella-shaped structure and the lantern-shaped structure have a circular cross section, and the maximum diameter of the longitudinal section of the mushroom structure is larger than The maximum diameter of the longitudinal section of the lantern-shaped structure.
A left atrial appendage occluder according to claim 5, wherein the longitudinal cross-sectional diameter of the lantern-shaped structure first increases from the left atrial appendage to the left atrial appendage and then decreases.
A left atrial appendage occluder according to claim 4, wherein the compressed occluder is moved back and forth in the left atrial appendage.
The left atrial appendage occluder according to claim 5, wherein the restored front end of the bracket is fixedly attached to the inner wall of the left atrial appendage, and the rear end of the bracket after the restored shape is fixed and closed. In the left atrial appendage.