CN104306040A - Left atrial appendage plugging device - Google Patents

Abstract

The invention provides a left atrial appendage occluder, which comprises a mesh-shaped support braided with shape-memory wires, the support is a spherical structure, a flow-blocking membrane is provided on the support, and the shape-memory wires gather at both ends of the support Nodes are formed, at least one node is provided with connection joints, preferably, the nodes are respectively provided with connection joints, and the largest circumference of the support is provided with a plurality of anchor thorns whose tips are connected to the joints at one end of the support, the two The connecting joint is symmetrical with respect to the circumferential plane where the largest circumference is located. The main body of the present invention adopts a sphere structure, and the shape of the sphere after stretching can well meet the needs of different internal shapes of the left atrial appendage, greatly increasing the adaptability of the occlusion during use. The device is also equipped with anchor thorns, support arms and other structures, It can be well positioned in the left atrial appendage and has a good blocking effect. The invention has the advantages of simple overall structure and low cost.

Description

left atrial appendage occluder

technical field

The invention relates to a medical device, in particular to a left atrial appendage occluder used for left atrial appendage occlusion.

Background technique

At present, one out of every six people in the world may suffer from a stroke, and one person dies of a stroke every six seconds; the Ministry of Health also disclosed that Chinese people who die from strokes account for 22.45% of all deaths every year. 15%-20% of strokes are caused by atrial fibrillation, and more than 90% of thrombi in patients with atrial fibrillation are formed in the left atrial appendage, and the thrombosis of the left atrial appendage increases the risk of stroke by 3 times. In cardiac rhythm disturbances, thrombosis is 10%-20% in the case of the Left Atrial Appendage. Oral anticoagulant drugs can reduce the probability of atrial fibrillation or stroke, but because anticoagulant drugs will greatly increase the probability of intracranial hemorrhage, patients with contraindications to anticoagulant drugs cannot use this method.

With the development of interventional cardiology, for patients with atrial fibrillation who have contraindications to anticoagulation therapy, the interventional method can seal the left atrial appendage to prevent embolic complications and stroke. The interventional method uses a special medical device - the left atrial appendage occluder, Closing the left atrial appendage with a left atrial appendage occluder can prevent atrial fibrillation and reduce the risk of stroke. Atrium, to prevent blood flow; after the left atrial appendage occluder is placed in the left atrial appendage, the left atrial endothelial cells will crawl on the surface of the polymer membrane, and will be covered by new endothelial tissue after a period of time. After endothelialization, the left atrium will be closed. thereby preventing thrombosis. There are generally two methods for the implantation of the left atrial appendage occluder: one is to insert a specially designed atrial septal puncture sheath and then implant the left atrial appendage occluder through a catheter. This method is called atrial septal puncture implantation or simply Implantation in the left atrium; the second is to implant the occluder of the left atrial appendage directly from the outside of the left atrial appendage by surgery. This method is generally called lateral implantation of the left atrial appendage. The above two methods are selected according to the actual situation of the patient and the experience of the doctor. Because the two methods belong to different technical means, there is a certain difference between the device used and the left atrial appendage occluder, and the existing left atrial appendage occluder is not perfect, and there are still problems of easy falling off and unstable positioning. As a result, the effect of blocking blood is not good, so how to solve the above-mentioned shortcomings is a technical problem to be solved urgently by those skilled in the art.

Contents of the invention

The technical problem to be solved by the present invention is to provide a left atrial appendage occluder which has a simple structure and can effectively fit the inner wall of the left atrial appendage for occlusion, so as to overcome the above-mentioned defects of the prior art.

In order to solve the above-mentioned technical problems, the present invention adopts the following technical solutions: a left atrial appendage occluder, comprising a mesh-shaped support braided with shape-memory wires, the support is a spherical structure, and a flow-blocking membrane is provided on the support. The shape memory wires gather at both ends of the stent to form nodes, and at least one node is provided with a connecting joint.

Preferably, the two nodes are respectively provided with connection joints, and the largest circumference of the support is provided with a plurality of anchor thorns whose tips are connected to the joints at one end of the support, and the circumference where the two connection joints are opposite to the largest circumference faces say.

Further, the materials of the anchor barb and the shape memory wire are nickel-titanium alloy wire.

Preferably, the bracket forms a conical protrusion on the side where one of the nodes is located, and the connecting joint is on the conical point of the conical protrusion.

Further, a plurality of bendable support arms are provided on the conical protrusion, one end of the support arm is fixed on the conical protrusion, and the other end is supported on the inner wall of the left atrial appendage.

Preferably, an elastic member providing tension is provided between two nodes inside the bracket.

Further, the elastic member is a tension spring.

Preferably, both ends of the bracket are flat end faces, and the connecting joint is located in the middle of the flat end faces.

As mentioned above, the left atrial appendage occluder of the present invention has the following beneficial effects:

The left atrial appendage occluder of the present invention is designed by braiding nickel-titanium alloy wire, the main body adopts a spherical structure, and the shape of the sphere after stretching can well meet the needs of different internal shapes of the left atrial appendage, greatly increasing the adaptability of the occluded use, And because this device is designed with a spherical structure, it is also equipped with anchor thorns, support arms and other structures, so it has a larger bonding area with the inner wall of the left atrial appendage, better bonding stability, and a better blocking effect. good.

The overall structure of the present invention is simple, the cost is low, and the device is provided with two connecting joints, so it can meet the needs of the two surgical methods of left atrium implantation and left atrial appendage implantation at the same time, greatly improving the flexibility of the operation , the doctor can adopt different operation methods according to the actual situation of the patient, so this device has great use value and development prospect.

Description of drawings

Fig. 1 is the first structure diagram of the present invention.

FIG. 2 is a schematic perspective view of FIG. 1 .

Fig. 3 is a schematic diagram of an arrangement mode of the flow blocking film in the present invention.

Fig. 4 is a second structure diagram of the present invention.

Fig. 5 is a third structure diagram of the present invention.

Fig. 6 is a preferred embodiment of Fig. 5 .

Fig. 7 is a fourth structure diagram of the present invention.

In the figure: 1 bracket 11 tapered protrusion

2 Flow blocking film 3 Connecting joint

4 anchor thorns 5 support arms

6 Elastic parts

Detailed ways

The structures, proportions, sizes, etc. shown in the accompanying drawings of the description are only used to match the content disclosed in the description, for those who are familiar with the technology to understand and read, and are not used to limit the conditions for the implementation of the present invention, so there is no Technically, any modification of structure, change of proportional relationship or adjustment of size shall still fall within the scope of the technical content disclosed in the present invention without affecting the functions and objectives of the present invention. within the range that can be covered. At the same time, terms such as "upper", "lower", "front", "rear", and "middle" quoted in this specification are only for the convenience of description, and are not used to limit the scope of the present invention. , the change or adjustment of its relative relationship, without substantive changes in the technical content, should also be regarded as the scope of the present invention that can be implemented.

As shown in Fig. 1-Fig. 2, a left atrial appendage occluder is invented, which includes a mesh support 1 braided with shape-memory wires. The support 1 is a spherical structure, and the support 1 is provided with a flow-blocking membrane 2. The shape memory wires gather at both ends of the stent 1 to form nodes, and at least one of the nodes is provided with a connecting joint 3, and the connecting joint 3 is used to cooperate with a tool for transporting the device. Because the device has a spherical structure, by connecting the joint 3, the device can be operated in any one of left atrium implantation and left atrial appendage implantation. The flow blocking film 2 of the device is sewn on the bracket 1 by sutures, the flow blocking film 2 is made of materials such as polytetrafluoroethylene or polyethylene terephthalate, and the flow blocking film 2 can be arranged in many ways. For example, as shown in Figure 1, a layer of flow-blocking film 2 is sewn on the cross-section of the bracket 1, and the two nodes are symmetrical to the cross-section, and the flow-blocking film 2 can also be provided with multiple layers as required; as shown in Figure 3 As shown, the flow blocking film 2 can also be coated on the outer surface of the stent 1. It can be completely covered or partially covered. It has been verified by experiments that the hemisphere of the stent 1 can be coated with the flow blocking film 2. A good blocking effect can be achieved without affecting the overall performance; in addition, the flow blocking film 2 can also be sewn on the inner surface of the stent 1 . In this embodiment, inside the bracket 1, there is an elastic member 6 that provides tension between two nodes, and the elastic member 6 plays the role of pulling the two ends of the device closer, so that the middle position of the device is affected by the two nodes. The pressure forms an outward tension, and then more firmly abuts against the inner wall of the left atrial appendage. Further, the elastic member 6 in this embodiment is a tension spring.

In this embodiment, the two nodes are respectively provided with connection joints 3, and the largest circumference of the support 1 is provided with a plurality of anchor thorns 4 whose tips face the connection joint 3 at one end of the support 1. The two connection joints 3 It is symmetrical with respect to the circumferential plane where the largest circle is located. Further, the anchor thorns 4 are evenly arranged on the largest circumference of the stent 1 to ensure the support positioning effect. The positioning of the device in the left atrial appendage can be made firmer by the function of the anchor thorn 4 . After the device is implanted in the left atrial appendage, the tip of the anchor thorn 4 faces the left atrium side, thereby preventing the device from falling off and entering the left atrium; Connection joints 3 are respectively set on the nodes. Both the anchor barb 4 and the shape memory wire described in the present invention are nickel-titanium alloy wires. In addition, in order to allow the anchor thorn 4 to have greater deformation and greater adaptability when released, the anchor thorn 4 is U-shaped, that is, curved, thereby allowing a greater deformation margin.

As shown in FIG. 4 , the bracket 1 forms a conical protrusion 11 on the side where one node is located, and the connecting joint 3 is on the conical tip of the conical protrusion 11 . In this embodiment, preferably, the connecting joint 3 is provided with two, one of which is on the conical point of the conical protrusion 11, and the other is on the node at the other end of the bracket 1, so that the present invention can be used from the left The left atrial appendage is implanted outside the atrial appendage, and can be implanted in the left atrial appendage from the left atrium. Because the inner cavity of the left atrial appendage is irregular, the side where the inner cavity communicates with the left atrium is larger, and the other side is smaller, and the conical protrusion 11 can better adapt to the smaller side of the left atrial appendage, which is convenient for the device to communicate with the left atrium. The inner wall of the left atrial appendage is supported against it.

As shown in Figure 5, the conical protrusion 11 is provided with a plurality of bendable support arms 5, one end of the support arm 5 is fixed on the conical protrusion 11, and the other end is supported on the inner wall of the left atrial appendage, further Specifically, the support arms 5 are evenly distributed on a circumference, so as to play positioning and centering functions. The so-called centering is to prevent the stent 1 from shifting and twisting, so as to avoid the effect of blocking the blood due to the shifting or twisting. Because the support arm 5 is evenly distributed on a circle, it can adjust the inner wall of the left atrial appendage. The pressure on each support arm 5 is as equal as possible to further ensure the stable support of the device in the left atrial appendage.

As shown in Figure 6, it is the preferred embodiment of Figure 5, wherein the anchor thorn 4 is an upside-down U-shaped structure, because the anchor thorn 4 is a nickel-titanium alloy material, so it has good bending performance, and the U-shaped structure is more flexible. Therefore, designing the anchor thorn 4 into a U-shaped structure can not only achieve the effect of supporting the inner wall of the left atrial appendage, but also prevent the tip of the anchor thorn 4 from directly abutting on the inner wall of the left atrial appendage. If the tip of the anchor thorn 4 is not directly against the inner wall of the left atrial appendage, the endothelialization speed can be reduced, which is beneficial to the later operation when the occluder needs to be taken out. The U-shaped anchor thorn 4 can effectively control the overall force of the present invention in the left atrial appendage because of its improved elastic performance, and prevent uneven force from causing deviation and affecting the occlusion effect.

As shown in Figure 7, it is another embodiment of the present invention. The two ends of the shown bracket 1 are flat end faces, and the connecting joint 3 is in the middle of the flat end face, which can reduce the impact of the device on the left atrium and the left atrial appendage. volumetric occupancy and impact.

The operation method of the present invention is the same as that of the conventional left atrial appendage occluder, all of which are implanted into the left atrial appendage through a sheath, then pushed out and released by a delivery tool, and supported on the inner wall of the left atrial appendage.

To sum up, the left atrial appendage occluder of the present invention can solve the problems of unstable positioning and poor blood blocking effect of the left atrial appendage occluder in the prior art. Therefore, the present invention effectively overcomes some practical problems in the prior art and thus has high utilization value and use significance.

The above-mentioned embodiments are only illustrative to illustrate the principles and effects of the present invention, but are not intended to limit the present invention. There are still many aspects of the present invention that can be improved without violating the general idea. Those who are familiar with this technology can modify or change the above-mentioned embodiments without violating the spirit and scope of the present invention. Therefore, all equivalent modifications or changes made by those skilled in the art without departing from the spirit and technical ideas disclosed in the present invention should still be covered by the claims of the present invention.

Claims (8)

1. a left atrial appendage occluder, characterized in that: comprise a mesh support (1) of shape memory wire weaving, said support (1) is a spherical structure, and said support (1) is provided with a flow blocking membrane (2), the shape memory wires gather at both ends of the stent (1) to form nodes, and at least one node is provided with a connecting joint (3). 2. The left atrial appendage occluder according to claim 1, characterized in that: the two nodes are respectively provided with connecting joints (3), and the largest circumference of the support (1) is provided with a plurality of tips facing One end of the bracket (1) is connected to the anchor thorns (4) of the joints (3), and the two connecting joints (3) are symmetrical with respect to the circumferential plane where the largest circumference is located. 3. The left atrial appendage occluder according to claim 2, characterized in that: the materials of the anchor (4) and the shape memory wire are nickel-titanium alloy wire. 4. The left atrial appendage occluder according to claim 1, characterized in that: the support (1) forms a conical protrusion (11) on the side where one node is located, and the connecting joint (3) is On the cone tip of the conical protrusion (11). 5. The left atrial appendage occluder according to claim 4, characterized in that: the conical protrusion (11) is provided with a plurality of bendable support arms (5), and the support arms (5) One end is fixed on the conical protrusion (11), and the other end is supported on the inner wall of the left atrial appendage. 6 . The left atrial appendage occluder according to claim 1 , characterized in that: inside the bracket ( 1 ), an elastic member ( 6 ) providing tension is arranged between two nodes. 7. The left atrial appendage occluder according to claim 6, characterized in that: the elastic member (6) is a tension spring. 8. The left atrial appendage occluder according to claim 1, characterized in that: both ends of the bracket (1) are flat end faces, and the connecting joint (3) is at the middle position of the flat end faces.