WO2018166377A1

WO2018166377A1 - New occluding device for septal defect

Info

Publication number: WO2018166377A1
Application number: PCT/CN2018/078145
Authority: WO
Inventors: 刘云奇; 殷胜利; 郭少成; 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: CN106821427A; CN106821427B

Abstract

Provided is a new occluding device for septal defect comprising a barrier layer, a first stent (3), a second stent (4), a first fixed connecting piece (1) and a second fixed connecting piece (2). According to the present invention, the new occluding device for septal defect opens up new perspectives for closing a septal defect thanks to the occluding force applied between the septal defect to clamp the edges efficiently. Unlike the prior art where occluding devices have a fixed dimension for the wraist, said new occluding device occludes the septal defect by clamping the edges thereof.

Description

Novel atrial septal defect occluder

Technical field

The invention relates to the technical field of medical instruments, in particular to a novel atrial septal defect occluder.

Background technique

Atrial septal defect is a common congenital heart disease in the clinic. The lesion is characterized by the failure of the atrial septum between the left and right atrium to close normally, and the blood flowing between the left atrium and the right atrium. The defect of the septum is mainly formed during the growth and development of the fetus, and the development of the heart is affected by certain factors, thereby forming atrial septal defect. For patients with atrial septal defect, because the pressure of the left atrium is higher than that of the right atrium, part of the blood in the left atrium flows to the right atrium through the atrial septal defect, resulting in an increase in the burden of the right heart system, causing right ventricular hypertrophy and pulmonary circulation. Increased, long-term presence of atrial septal defect can cause pulmonary hypertension, congestive heart failure, arrhythmia, stroke, dizziness, fainting and other diseases.

Surgery is the traditional method for the treatment of atrial septal defect. However, surgical treatment of atrial septal defect requires thoracotomy, which has the following disadvantages: extracorporeal circulation is required during surgery, which may cause complications and death; trauma is large, and remains on the body surface The scar of the lower surgical incision; at the same time, the cost of surgery is high. In order to avoid thoracotomy in patients with atrial septal defect, medical researchers conducted non-surgical methods for the treatment of atrial septal defect in the 1960s, and invented various occluders such as Rishkind, Sideris and The Amplatzer occluder, which is delivered to the occluder through the cardiac catheter to close the atrial septal defect, achieves comparable efficacy to surgical thoracotomy and avoids blood transfusions and complications caused by blood transfusions and surgery. However, clinical application found that Rishkind and Sideris occluder have low success rate and high incidence of complications, and are gradually eliminated. In recent years, the most widely used clinically is the Amplatzer occluder, which has a double-disc thin waist structure. With a fixed waist size, it is often difficult to tighten the "soft edge" of the atrial septal defect, resulting in residual leakage during and after surgery, resulting in atrial septal defect failure or incomplete closure, and this standardized occluder design It is difficult to meet the complex and variable atrial anatomy and is also prone to complications. As for other occluders developed to accommodate atrial septal defects of different anatomical forms, there are drawbacks of complex models, inconvenience in production and use, and increased surgical complexity. Therefore, it is necessary to develop a new type of occluder that is simple to produce and use and can avoid residual leakage during and after surgery.

Summary of the invention

In view of the above problems, the inventors of the present invention conducted in-depth research and analysis on atrial septal defect, and continuously carried out experiments to develop a novel atrial septal defect occluder, which has a simple structure and can adapt to atrial septal defect of different anatomical forms and is difficult to be used. Residual leakage occurred during and after surgery.

In order to achieve the above object, the present invention provides a novel atrial septal defect occluder comprising a thin film barrier layer, a first stent body, a second stent body, a first fixed connector and a second fixed connector, wherein The first bracket body and the second bracket body are woven from a compressible deformable memory metal alloy wire, wherein two ends of the memory metal alloy wire in the first bracket body are fixedly connected to the front end of the first fixed connecting member and a front end of the second fixing connector, the two ends of the memory metal alloy wire in the second bracket body are fixedly connected to the rear end of the first fixing connector and the rear end of the second fixing connector respectively; the first fixing connector and The second fixing connector is a cylindrical structure and the front end of the first fixing connector and the rear end of the second fixing connector are provided with internal threads for connecting the conveying system; the film barrier layer is built into the first bracket body and the second bracket body in.

In the novel atrial septal defect occluder of the present invention, the type of the internal thread matches the type of the threaded structure of the delivery system of the occluder of the present invention during the treatment of the atrial septal defect, the delivery system may be An occluder delivery device conventionally used in the art.

At the time of surgery, the novel atrial septal defect occluder of the present invention is connected to the delivery system, and the occluder is delivered to the atrial septal defect through the delivery system. Due to the characteristics of the memory metal alloy, the first stent body and the second stent The stent body returns to a predetermined shape to clamp the edge of the atrial septal defect, closes the atrial septal defect, and then releases the occluder to end the operation. The novel atrial septal defect occluder of the present invention avoids residual leakage due to the formation of a large clamping force between the first stent body and the second stent body, and improves the existing occluder due to having a fixed waist structure. Unable to clamp the edge of the atrial septal defect.

Preferably, in the novel atrial septal defect occluder of the present invention, the first fixed connector and the second fixed connector have a length of 1 mm to 3 mm, preferably 1 mm to 2 mm. If the length of the first fixed connecting piece and the second fixed connecting piece is too small, the number of internal thread turns in the inner part is too small, which may cause the connection with the conveying system to be weak and the risk of the occluder and the conveying system falling off during the operation. Conversely, if the length of the first fixed connector and the second fixed connector are too large, the risk of local thrombus formation on the surface of the occluder is increased, and the first stent body and the second stent body are easily restored to a predetermined shape. When the distance between the first fixed connector and the second fixed connector is too small, the first bracket body and the second bracket body are affected to clamp the soft edge of the atrial septal defect.

Preferably, in the novel atrial septal defect occluder of the present invention, the first fixed connecting piece and the second fixed connecting piece have an inner diameter of 1-2 mm if the inner diameter of the first fixed connecting piece and the second fixed connecting piece are If it is too small, the connection between the occluder and the fixing rod is not reliable; conversely, if the inner diameters of the first fixed connecting piece and the second fixed connecting piece are too large, the occluder may be oversized after being folded and folded.

Preferably, in the novel atrial septal defect occluder of the present invention, the thin film barrier layer is composed of a high biocompatibility high material such as polylactic acid, polyglycolic acid and polyanhydride. The thin film barrier layer is composed of a polymer material having good biocompatibility, which can significantly improve the biocompatibility of the occluder.

More preferably, in the novel atrial septal defect occluder of the present invention, the thin film barrier layer is a biofilm having a uniform thickness and a thickness of 0.1 mm to 0.2 mm. If the thickness of the thin film barrier layer is too small, the thin film barrier layer is easily broken due to the impact of blood flow; conversely, if the thickness of the thin film barrier layer is too large, the weight of the thin film barrier layer is increased, resulting in the weight of the occluder Also increased, is not conducive to the closure of atrial septal defect.

Preferably, in the novel atrial septal defect occluder of the present invention, the predetermined shape of the first stent body and the second stent body is an intermediate convex lantern shape. In use, since the memory metal alloy is continuously reshaped, the first bracket body and the second bracket body are restored to a preset lantern shape, and the first bracket body and the second bracket body of the lantern form a large clamping force. The entire occluder can better clamp the edge of the atrial septal defect and close the atrial septal defect.

More preferably, in the novel atrial septal defect occluder of the present invention, the first stent body and the second stent body are restored to the longitudinal direction of the intermediate convex lantern-shaped intermediate convex lantern-shaped intermediate projection. The cross section is circular and its diameter is 5mm-50mm. The novel atrial septal defect occluder of the present invention can select a first stent body and a second stent body of an appropriate size according to the size of the atrial septal defect estimated in advance by the cooperation of X-ray, angiography and color Doppler ultrasound, Better achieve the perfect fit between the occluder and the atrial septal defect.

Preferably, in the novel atrial septal defect occluder of the present invention, the number of memory metal alloy wires in the first stent body and the second stent body is 20-30. If the number of memory metal alloy wires in the first bracket body and the second bracket body is too small, the first bracket body and the second bracket body cannot form a sufficient clamping force to clamp the edge of the atrial septal defect to close the room. Interval defect, prone to shedding phenomenon; conversely, if the number of memory metal alloy wires in the first stent body and the second stent body is too large, the weight of the occluder will increase significantly, which also increases the risk of shedding. .

Preferably, in the novel atrial septal defect occluder of the present invention, the diameter of the memory metal alloy wire in the first stent body and the second stent body is 0.1-0.2 mm. If the diameter of the memory metal alloy wire in the first bracket body and the second bracket body is too small, the first bracket body and the second bracket body are too thin and have insufficient strength due to the memory metal alloy wire being too thin, and there is insufficient support. Force, so that the entire occluder is easy to shape; conversely, if the diameter of the memory metal alloy wire in the first stent body and the second stent body is too large, the weight of the occluder will increase significantly, which increases the risk of shedding. .

Preferably, in the novel atrial septal defect occluder of the present invention, the first stent body and the second stent body are compressed into a cylindrical mesh structure, and the structure can easily enter the interatrial septum when in use. Defect.

Preferably, in the novel atrial septal defect occluder of the present invention, the surfaces of the first fixed connector, the second fixed connector, the first bracket body and the second bracket body are plated with a carbon thin film layer, thereby improving the whole The anti-corrosion effect of the occluder prevents metal ions from entering the blood and effectively controls the formation of blood clots, making the use safer.

In the novel atrial septal defect occluder of the present invention, the thin film barrier layer is respectively attached to the wire of the first stent body and/or the second stent body to be clamped on the first stent body and/or the second The space enclosed by the wire of the bracket body.

The novel atrial septal defect occluder of the present invention provides a new idea of closing atrial septal defect, effectively clamping the edge of the atrial septal defect with the clamping force between the occluder, instead of having an existing occluder The fixed waist size closes the atrial septal defect by clamping the edge of the atrial septal defect.

It should be noted that in the present invention, "first" and "second" do not represent a specific number and order, but are merely used to distinguish names.

Compared with the prior art, the present invention has the following beneficial effects and advantages:

(1) The novel atrial septal defect occluder of the invention has technical advancement and is an unprecedented innovative design; and the unique structure is far from the comparison of the existing occluder, and the structure is firm and the shape is reasonable. Appropriate elasticity, easy implantation and easy positioning, it is very suitable for standardized production and large-scale application;

(2) The novel atrial septal defect occluder of the present invention provides a new idea of closing atrial septal defect, and a large clamping force is formed between the first stent body and the second stent body to close the atrial septal defect, thereby avoiding Residual leakage improves the existing occluder because it has a fixed waist structure and cannot clamp the edge of the atrial septal defect;

(3) The novel atrial septal defect occluder of the present invention can select a first stent body and a second stent of a suitable size according to the size of the atrial septal defect estimated in advance by the cooperation of X-ray, angiography and color Doppler ultrasound. Body, in order to better achieve the fit of the occluder and the atrial septal defect, there will be no model mismatch, the occluder size is significantly larger than the atrial septal defect, avoiding material waste, thereby reducing costs.

DRAWINGS

The drawings are intended to provide a further understanding of the invention, and are intended to be a

1 is a schematic structural view of a novel atrial septal defect occluder in a compressed state according to the present invention;

2 is a schematic structural view of another perspective view of the novel atrial septal defect occluder in the compressed state of FIG. 1;

3 is a schematic structural view of the novel atrial septal defect occluder of FIG. 1 after restoring shape;

4 is a structural schematic view of another perspective view of the restored shape of the novel atrial septal defect occluder of FIG. 1.

Reference mark:

1 first fixed connection;

2 second fixed connection;

3 first bracket body;

4 second bracket body;

5 internal thread;

6 Memory metal alloy wire.

detailed description

In the following detailed description, reference will be made to the accompanying drawings that form a part of this specification. The aspects of the invention, which are generally described herein and illustrated in the drawings, may be arranged, substituted, combined, and in a broad configuration variation without departing from the spirit and scope of the inventive subject matter. It is intended that all such permutations, substitutions, combinations and divisions fall within the scope of the invention.

It should be noted that, in the description of the present specification, the orientation or positional relationship of the terms "front", "rear" and the like is based on the orientation or positional relationship shown in the drawings, and is merely for convenience of description of the present invention and simplified description. Rather than indicating or implying that the device or unit referred to has a particular orientation, construction and operation in a particular orientation, it is not to be construed as limiting the invention.

All technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs, unless otherwise defined. The terminology used in the description of the present invention is for the purpose of describing particular embodiments and is not intended to limit the invention.

The specific embodiments of the present invention are further described below in conjunction with the drawings and specific embodiments.

1 is a schematic structural view of a novel atrial septal defect occluder in a compressed state according to the present invention, and FIG. 2 is a structural schematic view of another perspective view of the novel atrial septal defect occluder in a compressed state of FIG. The structural schematic diagram of the novel atrial septal defect occluder after restoration of the shape, and FIG. 4 is a structural schematic view of another perspective of the restored shape of the atrial septal defect occluder of FIG. As can be seen in conjunction with Figures 1-4, the novel atrial septal defect occluder of the present invention includes a first stent body 3, a second stent body 4, a first fixation connector 1 and a second fixation connector 2, wherein the first stent body 3 And the second bracket body 4 is woven from the compressible and deformable memory metal alloy wire 6, wherein the two ends of the memory metal alloy wire 6 in the first bracket body 3 are fixedly connected to the front end of the first fixed connecting member 1, respectively. And the front end of the second fixing connector 2, the two ends of the memory metal alloy wire 6 in the second bracket body 4 are fixedly connected to the rear end of the first fixing connector 1 and the rear end of the second fixing connector 2, respectively. That is, one end of the memory metal alloy wire 6 in the first bracket body 3 is fixedly connected to the front end of the first fixed connecting member 1, and the other end is fixedly connected to the front end of the second fixed connecting member 2, and the second bracket body 4 is One end of the memory metal alloy wire 6 is fixedly connected to the rear end of the first fixed connection member 1 and the other end is fixedly connected to the rear end of the second fixed connection member 2; the first fixed connection member 1 and the second fixed connection member 2 a cylindrical structure and a front end and a second of the first fixed connector 1 The rear end of the fixed connecting member 2 is provided with an internal thread 5 for connecting the conveying system. In the present embodiment, the internal thread 5 is disposed at the front end of the first fixed connecting member 1 and the rear end of the second fixed connecting member 2; however, the present invention The occluder further includes a thin film barrier layer, but not shown in the drawings, wherein the thin film barrier layer is built into the first stent body 3 and the second stent body 4.

The compressed shape of the first bracket body 3 and the second bracket body 4 is a cylindrical net body structure, so that the entire occluder is cylindrical in a compressed state. This structure makes it easy to enter the atrial septal defect when in use.

The predetermined shape of the first bracket body 3 and the second bracket body 4 is an intermediate raised lantern shape. In use, since the memory metal alloy continues to be reshaped, the first bracket body 3 and the second bracket body 4 are restored to a predetermined lantern shape, and the first bracket body 3 and the second bracket body 4 formed in a lantern shape are formed larger. The clamping force enables the entire occluder to better clamp the atrial septal defect edge and close the atrial septal defect.

The memory metal alloy wires 6 in the first stent body 3 and the second stent body 4 are all 25, but the number of the memory metal alloy wires 6 may be other numbers, preferably in the range of 20-30. . If the number of memory metal alloy wires in the first bracket body 3 and the second bracket body 4 is too small, the first bracket body 3 and the second bracket body 4 cannot form a sufficient clamping force to clamp the atrial septal defect. The edge is closed in the closed atrial septum and is prone to shedding. On the contrary, if the number of memory metal alloy wires in the first stent body 3 and the second stent body 4 is too large, the weight of the occluder is significantly increased. It also increases the risk of shedding. In addition, in order to obtain a better clamping force to completely close the atrial septal defect, the memory metal alloy wire 6 in the first stent body 3 and the second stent body 4 is uniformly fixedly connected to the first fixed connector 1 And the second fixed connector 2 is attached.

When the first bracket body 3 and the second bracket body 4 are restored to the intermediate convex lantern shape, the longitudinal section of the intermediate convex lantern-shaped intermediate protrusion is circular, and the diameter thereof is 5 mm to 50 mm. The novel atrial septal defect occluder of the present invention has a relatively wide range of sizes, and can be selected according to the size of the atrial septal defect estimated by X-ray, angiography, and color Doppler in advance. The stent body 3 and the second stent body 4 are better to achieve a perfect fit between the occluder and the atrial septal defect.

Further, the diameter of the memory metal alloy wire 6 in the first holder body 3 and the second holder body 4 is 0.1 to 0.2 mm. If the diameter of the memory metal alloy wire 6 in the first holder body 3 and the second holder body 4 is too small, the first holder body 3 and the second holder body 4 are too thin and the strength is too small because the memory metal alloy wire 6 is too thin. , there is not enough supporting force, so that the entire occluder is easy to shape; conversely, if the diameter of the memory metal alloy wire 6 in the first bracket body 3 and the second bracket body 4 is too large, the weight of the occluder is Will increase significantly, will increase the risk of shedding.

In addition, the first fixed connector 1, the second fixed connector 2, the first bracket body 3 and the second bracket body 4 are plated with a carbon film layer on the surface, thereby improving the anticorrosion effect of the entire occluder and preventing metal ions. Entering the blood, effectively controlling the formation of blood clots, making it safer to use.

In addition, the first fixed connection 1 and the second fixed connection 2 have a length of 1 mm to 3 mm, preferably 1 mm to 2 mm. If the lengths of the first fixed connecting piece 1 and the second fixed connecting piece 2 are too small, the number of internal threads 5 of the inner part thereof is too small, which may cause the connection with the conveying system to be weak and the occluder and the conveying system exist during the operation. The risk of shedding; conversely, if the length of the first fixed connector 1 and the second fixed connector 2 is too large, the risk of local thrombosis on the surface of the occluder is increased, and the first stent body 3 and the second stent are easily caused. When the body 4 is restored to the preset shape, the distance between the first fixed connector 1 and the second fixed connector 2 is too small, which affects the soft edges of the first bracket body 3 and the second bracket body 4 that clamp the atrial septal defect.

Moreover, the inner diameters of the first fixed connection member 1 and the second fixed connection member 2 are 1 mm to 2 mm, and if the inner diameters of the first fixed connection member 1 and the second fixed connection member 2 are too small, the occluder is The connection between the fixing rods is not reliable; conversely, if the inner diameters of the first fixed connecting piece 1 and the second fixed connecting piece 2 are too large, the size of the occluder may be too large after being folded and folded. .

Regarding the thin film barrier layer, it is composed of a high biocompatibility high material such as polylactic acid, polyglycolic acid, and polyanhydride. The thin film barrier layer is composed of a polymer material having good biocompatibility, which can significantly improve the biocompatibility of the occluder.

Further, the thin film barrier layer is a biofilm having a uniform thickness and a thickness of 0.1 mm to 0.2 mm. If the thickness of the thin film barrier layer is too small, the thin film barrier layer is easily broken due to the impact of blood flow; conversely, if the thickness of the thin film barrier layer is too large, the weight of the thin film barrier layer is increased, resulting in the weight of the occluder Also increased, is not conducive to the closure of atrial septal defect.

At the time of surgery, the novel atrial septal defect occluder of the present invention is connected to the delivery system, and the occluder is delivered to the atrial septal defect through the delivery system. Due to the characteristics of the memory metal alloy, the first stent body and the second stent The stent body returns to a predetermined shape to clamp the edge of the atrial septal defect, closes the atrial septal defect, and then releases the occluder to end the operation.

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, and the modifications and variations of the invention are intended to fall within the scope of the appended claims. In addition, although specific terms are used in the specification, these terms are merely for convenience of description and do not limit the invention.

Claims

A novel atrial septal defect occluder comprising a thin film barrier layer, a first stent body, a second stent body, a first fixed connector and a second fixed connector, wherein the first stent body and the second stent The body is woven by a compressible and deformable memory metal alloy wire, wherein two ends of the memory metal alloy wire in the first bracket body are fixedly connected to the front end of the first fixed connecting piece and the front end of the second fixed connecting piece, respectively. The two ends of the memory metal alloy wire in the second bracket body are respectively fixedly connected to the rear end of the first fixing connector and the rear end of the second fixing connector; the first fixing connector and the second fixing connector are cylindrical The front end of the first fixing connector and the rear end of the second fixing connector are provided with internal threads for connecting the conveying system; the film barrier layer is built into the first bracket body and the second bracket body.
The novel atrial septal defect occluder according to claim 1, wherein the first fixed connecting piece and the second fixed connecting piece have a length of 1 mm to 3 mm, preferably 1 mm to 2 mm, and a diameter of 1 mm. 2mm.
The novel atrial septal defect occluder according to claim 1, wherein the thin film barrier layer is a biofilm having a uniform thickness and a thickness of 0.1 mm to 0.2 mm.
The novel atrial septal defect occluder according to claim 1, wherein the predetermined shape of the first bracket body and the second bracket body is an intermediate convex lantern shape.
The novel atrial septal defect occluder according to claim 4, wherein the first bracket body and the second bracket body are restored to an intermediate convex lantern-shaped intermediate convex lantern-shaped intermediate protrusion The longitudinal section is circular and has a diameter of 5 mm to 50 mm.
The novel atrial septal defect occluder according to any one of claims 1 to 5, wherein the number of memory metal alloy wires in the first stent body and the second stent body is 20-30 .
The novel atrial septal defect occluder according to any one of claims 1 to 5, wherein the diameter of the memory metal alloy wire in the first stent body and the second stent body is 0.1-0.2 mm .
The novel atrial septal defect occluder according to any one of claims 1 to 5, wherein the first fixed connecting piece, the second fixed connecting piece, the first bracket body and the second bracket body are plated on the surface There is a carbon film layer.
The novel atrial septal defect occluder according to any one of claims 1 to 5, wherein the first stent body and the second stent body are compressed in a cylindrical mesh structure.