WO2016049991A1

WO2016049991A1 - Left atrial appendage occlusion apparatus

Info

Publication number: WO2016049991A1
Application number: PCT/CN2014/095910
Authority: WO
Inventors: 蒲忠杰; 周而辰; 陈娟; 杨永森
Original assignee: 上海形状记忆合金材料有限公司
Priority date: 2014-09-29
Filing date: 2014-12-31
Publication date: 2016-04-07
Also published as: CN104274224B; CN104274224A

Abstract

A left atrial appendage occlusion apparatus comprises an inner disc surface (11) and an outer disc surface (12) knitted by shaped memory silk threads. The center of the inner disc surface (11) is connected to the center of the outer disc surface (12) by means of a connecting portion (13). The connecting portion (13) is a prefabricated rod. The inner disc surface (11) and the outer disc surface (12) are respectively fixed to two ends of the connecting portion (13). A flow blocking membrane (2) is disposed in each of the inner disc surface (11) and the outer disc surface (12). A connector (3) is disposed on the outer disc surface (12). The connecting portion (13) is of a tubular structure with an inner cavity. A through hole is formed in the connector (3). The connecting portion (13) is connected to the connector (3), and the inner cavity of the connecting portion (13) is in communication with the through hole of the connector (3) to form a conveying channel. The left atrial appendage occlusion apparatus is implanted from the outer side of the left atrial appendage, and relates to a minimally invasive surgery. By means of the apparatus, a doctor can directly see the left atrial appendage, the operation process is simplified, the operation safety is improved, and the pains of a patient are relieved. In addition, the conveying channel is disposed, which allows a medicine or a contrast agent to be conveniently injected into a human body in the operation process.

Description

Left atrial appendage occluder

Technical field

The present invention relates to a medical device, and more particularly to an occluder for left atrial appendage closure.

Background technique

Atrial fibrillation (AF) is one of the most common arrhythmias in the clinic. The incidence rate of the population is about 0.89%, and the incidence increases with age. In addition to arousing and aggravating heart failure, atrial fibrillation can also cause stroke and other thrombotic events. About 5% of patients with atrial fibrillation have strokes each year, and the mortality and disability rate caused by stroke is as high as 50%. How to prevent or reduce stroke caused by atrial fibrillation is important. In recent years, several clinical studies have shown that blocking the left atrial appendage can reduce the risk of stroke in patients with atrial fibrillation. At present, the mainstream left atrial appendage occlusion in the world is percutaneous puncture and closure. The operation process is complicated, it requires puncture of the interatrial septum, the operation is difficult, the instruments used are more complicated, and X-ray is generally used as a guide during the operation. It has certain radiation damage to both doctors and patients. In addition, in the surgical procedure of percutaneous puncture closure, it is also necessary to determine the implantation position and the sealing effect of the occluder. The prior art is realized by X-ray or ultrasonic development, and the operation is performed by inserting one. Root development of the sheath to achieve, but for left atrial appendage surgery, if you want to insert the development sheath, you need to establish a development channel, the development channel from the venous puncture into the right atrium, and then puncture the interatrial septum into the left atrium, which The method not only increases the complexity of the surgery, but also increases the damage to the patient.

Chinese Patent No. ZL 200620068478.9 discloses a left atrial appendage occluder that can be automatically positioned in the left atrial appendage, comprising a nickel-titanium wire braided stent having a mesh structure and mounted in the stent. The separator is characterized in that the bracket is connected by a hollow disc-shaped plugging head and a hollow cylindrical positioning post, and the outer diameter of the disc-shaped plugging head is larger than the outer diameter of the cylindrical positioning post; A barrier film is mounted in both the plug and the cylindrical positioning post; a transfer connector is mounted on a side of the disc-shaped plug that is not connected to the cylindrical positioning post. This patent is implanted into the occluder by the above-mentioned percutaneous occlusion, although it can also complete the occlusion, but because of the complicated surgical procedure and the inconvenience of determining the position of the occluder, it still exists during the actual operation. Inadequacies. Therefore, how to reduce the complexity of the operation, reduce the injury of the patient, and at the same time facilitate the determination of the position of the occluder during the operation has been blocked, which has become a technical problem to be solved by those skilled in the art.

Summary of the invention

The technical problem to be solved by the present invention is to provide a left atrial appendage occluder implanted from the left atrial appendage, The sealing position and the sealing effect can be ensured to overcome the above-mentioned drawbacks of the prior art.

In order to solve the above technical problem, the present invention adopts the following technical solution: a left atrial appendage occluder includes an inner disk surface and an outer disk surface woven by a shape memory wire, and the centers of the inner disk surface and the outer disk surface are connected by a connecting portion. The connecting portion is a prefabricated rod, and the inner disc surface and the outer disc surface are respectively fixed at two ends of the connecting portion, and the inner disc surface and the outer disc surface are respectively provided with a blocking film, and the outer disc surface is provided with a connecting joint .

Preferably, the connecting portion is a tubular structure having an inner cavity, and the connecting joint is provided with a through hole, the connecting portion is connected with the connecting joint, and the inner cavity of the connecting portion is communicated with the through hole of the connecting joint to form A conveying channel.

Further, the conveying passage is provided with a one-way valve at an opening near one end of the inner disk surface.

Further, the one-way valve is constituted by a one-way diaphragm that closes the opening of the conveying passage and can only open to one side of the inner disc surface.

Further, the connecting portion is an elastic sleeve that is telescopic in length.

Further, the elastic sleeve is composed of a spring, an elastic membrane and an end tube fixed at a central position of the inner disc surface, one end of the spring is connected with the end tube, and the other end of the spring is connected with the joint The elastic membrane is coated on the outside of the spring, and the two ends of the elastic membrane are respectively connected with the end pipe and the joint to form a sleeve.

Preferably, the inner disk surface is hemispherical with its flat end surface facing the outer disk surface.

Preferably, a plurality of anchor thorns are uniformly disposed outside the largest circumferential surface of the inner disk surface, and the tip end of the anchor thorn faces the outer disk surface side.

Preferably, the shape memory wire for braiding the inner disk surface is thicker than the shape memory wire used to braid the outer disk surface.

Preferably, the shape memory wire is a nickel titanium alloy wire.

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

1. The invention is implanted from the lateral side of the left atrial appendage, and belongs to a surgical minimally invasive small incision operation, which not only simplifies the surgical procedure, but also greatly reduces the suffering of the patient.

2. The invention directly implants the left atrial appendage occluder on the left atrial appendage, so the doctor can directly view the left atrial appendage for the operation, which brings great convenience to the doctor's operation, shortens the operation time and makes the operation process safer. .

3. The invention is provided with a conveying channel for facilitating the injection of drugs or developers during the operation, and avoiding the use of additional special drugs for delivering drugs or developing agents to cause harm to the human body during the operation. The delivery channel is convenient for the doctor to operate, and whether the position of the occluder is in place and the operation is successful, further reducing the damage to the patient, reducing the difficulty of surgery, and further improving the safety of the operation.

DRAWINGS

Figure 1 is a schematic view of a first embodiment of the present invention.

2 is a schematic view of a second embodiment of the present invention.

Figure 3 is a schematic view of a third embodiment of the present invention.

Figure 4 is a schematic view of a fourth embodiment of the present invention.

Figure 5 is an enlarged view of A in Figure 4.

Figure 6 is a working principle diagram of the present invention.

In the picture: 11 inner disk surface 12 outer disk surface

13 Connections 131 One-way diaphragm

132 spring 133 elastic film

14 anchor thorn 2 blocking film

3 connector 4 left atrial appendage

5 left atrium

detailed description

The structure, the proportions, the sizes and the like of the drawings are only used to cope with the contents disclosed in the specification for understanding and reading by those skilled in the art, and are not intended to limit the conditions that can be implemented by the present invention. The technical significance, the modification of any structure, the change of the proportional relationship or the adjustment of the size should still fall within the technical content disclosed by the present invention without affecting the effects and the achievable purposes of the present invention. Within the scope that can be covered. In the meantime, the terms "upper", "lower", "previous", "post", "intermediate", and the like, are used in the description, and are not intended to limit the scope of the invention. Changes or adjustments in the relative relationship are considered to be within the scope of the present invention without substantial changes.

1 shows a left atrial appendage occluder according to the present invention, comprising an inner disk surface 11 and an outer disk surface 12 woven by a shape memory wire, the inner disk surface 11 and the outer disk surface 12 being connected by a connecting portion 13, the connection The portion 13 is a prefabricated rod, and the inner disc surface 11 and the outer disc surface 12 are fixed to both ends of the connecting portion 13, respectively. The prefabricated rod means that the connecting portion 13 is a separately manufactured member, and is not woven by the shape memory wire together with the inner disk surface 11 and the outer disk surface 12, and the surface of the connecting portion 13 does not have a mesh. The inner disk surface 11 and the outer disk surface 12 are each provided with a baffle film 2, and the outer disk surface 12 is provided with a connection joint 3, wherein the diameters of the inner disk surface 11 and the outer disk surface 12 are both much larger than the diameter of the connecting portion 13.

As shown in FIG. 2, in a preferred embodiment of the present invention, the connecting portion 13 is a tubular knot having a lumen. a connecting hole is formed in the connecting joint 3, the connecting portion 13 is connected to the connecting joint 3, and the inner cavity of the connecting portion 13 communicates with the through hole of the connecting joint 3 to form a conveying passage, and the conveying is performed. The channel can be used to deliver contrast or drugs. Further, the delivery channel is provided with a one-way valve at an end close to the inner disk surface 11 so that the contrast agent does not flow back, and at the same time prevents blood from flowing out of the left atrial appendage from the delivery channel. As shown in Fig. 5, a simplest one-way check valve is constituted by a one-way diaphragm 131 for closing the opening of the conveying passage and opening only to one side of the inner disc surface. In the embodiment, the flow-blocking film 2 is a polymer material such as PTFE (polytetrafluoroethylene), and the shape memory wire is a nickel-titanium alloy wire. The inner disk surface 11, the outer disk surface 12 and the connecting portion 13 described in the present invention are all independent structures, and in use, the three are integrally formed by laser welding. The connecting portion 13 of the device is much thinner than the middle portion of the conventional left atrial appendage occluder, and does not need to be opened when implanting the left atrial appendage, which can minimize the opening at the left atrial appendage during operation and accelerate the healing of the opening. Speed, relieve the pain of the patient.

In the present embodiment, the connecting portion 13 is an elastic sleeve that can be telescopically stretched, and can have various embodiments, such as the bellows shown in FIG. In a preferred mode of the embodiment, as shown in FIGS. 4 and 5, the elastic sleeve is composed of a spring 132, an elastic film 133 and an end tube 134, and the end tube 134 is fixed at the center of the inner disk surface 11. One end of the spring 132 is connected to the end tube 134, the other end of the spring 132 is connected to the connecting joint 3, the elastic film 133 is wrapped on the outside of the spring 132, and the two ends of the elastic film 133 are respectively connected with the end tube 134, The connector 3 is connected to form a sleeve. The connecting portion 13 in this embodiment has elastic stretchability, so that the inner disc surface 11 and the outer disc surface 12 can be clamped to the left atrial appendage by an elastic clamping force. The elastic film 133 in this embodiment is a polymer material such as PTFE (polytetrafluoroethylene), PE (polyethylene) or PET (polyethylene terephthalate).

The invention is implanted from the left atrial appendage at the time of surgery, so the design of the two disc faces is adopted, and the inner disc surface 11 is supported inside the left atrial appendage to prevent blood from entering the cavity of the left atrial appendage to form a thrombus, thereby preventing blood vessel embolism. The outer disk surface 12 acts as a limit on the outer side of the left atrial appendage to prevent the device from falling into the left atrium. Because the device is hung on the outside of the left atrial appendage, the outer disk surface 12 needs to be as small as possible to reduce the occupation area in the human body and avoid interference with other tissues or organs of the human body, and the inner disk surface 11 is supported in the left atrial appendage. The effect, therefore, needs to be slightly larger, which in turn can block the entire left atrial appendage and support it. In addition, since the inner disc surface 11 in the device is to ensure a stable supporting effect in the left atrial appendage, the nitinol wire of the inner disc surface 11 is relatively thick to ensure good support; and the outer disc surface 12 is outside the left atrial appendage. Therefore, the nitinol wire of the outer disk surface 12 is thinner to reduce the hardness and prevent damage to human tissues. Further, it has been verified by the inventors that the nitinol wire of the inner disk surface 11 is 0.11 mm to 0.20 mm in diameter and the nickel-titanium wire diameter of the outer disk surface 12 is 0.01 mm to 0.10 mm. Within the scope The diameters of the inner disk surface 11 and the outer disk surface 12 are optimal diameters.

As shown in FIG. 1, 2, 3 or 4, in the present embodiment, the inner disk surface 11 is hemispherical, and its flat end surface side faces the outer disk surface 12. The inner disk surface 11 adopts a hemispherical design to facilitate its release: the inner disk surface 11 is directly opened like an umbrella when implanted in the left atrial appendage; at the same time, it is designed to be hemispherical, so that the inner disk surface 11 faces the left ventricle side. The convex shape can increase the tension of the surface of the inner disk surface 11 and prevent the formation of a blood clot due to the blood pressure. Therefore, the hemispherical design of the device can effectively ensure the sealing effect and prevent thrombus formation.

In the present embodiment, a plurality of anchor ribs 14 are uniformly disposed outside the largest circumferential surface of the inner disk surface 11, and the tip end of the anchor thorn 14 faces the outer disk surface 12 side. The anchor 14 can assist the positioning of the device in the left atrial appendage to prevent slipping out of the left atrial appendage; and because the anchor puncture 14 is also a Nitinol material, it has good bending properties and therefore does not affect the release and recovery of the device.

3, 4, 5, the present invention is implemented at the time of surgery: after cutting the left side of the patient's left intercostal space, the left atrial appendage 4 is cut out of the opening, using ultrasound guidance, and then the delivery sheath The tube is implanted into the left atrial appendage 4, and then the connection joint 3 of the device is connected to the delivery tool, and is delivered from the outside of the left atrial appendage 4 into the left atrial appendage 4 through the delivery sheath; the inner disk surface 11 of the device is released from the delivery sheath Can be attached to the inner wall of the left atrial appendage 4, at the same time, the anchor thorn 14 is also supported on the inner wall of the left atrial appendage 4 to further determine the position of the entire device, and then pull back the delivery sheath to the outside of the left atrial appendage 4, so that the outer disk surface 12 is stuck to the left The outside of the opening cut out by the auricle 4 . The baffle film 2 in the inner disk surface 11 can effectively block blood from entering the left atrial appendage 4, and the baffle film 2 in the outer disk surface 12 can prevent the oozing blood from flowing out. Since the outer disk surface 12 is stuck at the opening, the two ends of the device sandwich the left atrial appendage so that the device does not slide into the left atrium 5 nor fall off the left atrial appendage 4. After the device is placed, the contrast agent is delivered through the delivery channel of the device, and the position of the device is determined by the contrast agent and whether the defect is completely blocked. After the confirmation is correct, the delivery sheath is withdrawn and the left atrial appendage is closed. Installation of the device.

In summary, the left atrial appendage occluder of the present invention can solve the problem of inaccurate positioning and inaccurate positioning when sealing the left atrial appendage. Therefore, the present invention effectively overcomes some practical problems in the prior art and has high utilization value and use significance.

The above-described embodiments are merely illustrative of the principles of the invention and its advantages, and are not intended to limit the invention. There are many aspects of the invention that can be modified without departing from the general idea, and those skilled in the art can modify or change the above-described embodiments without departing from the spirit and scope of the invention. Therefore, all equivalent modifications or changes made by those skilled in the art without departing from the spirit and scope of the invention will be covered by the appended claims.

Claims

A left atrial appendage occluder, comprising: an inner disk surface (11) and an outer disk surface (12) woven by a shape memory wire, the center of the inner disk surface (11) and the outer disk surface (12) passing through a connecting portion ( 13) connected, the connecting portion (13) is a prefabricated rod, and the inner disc surface (11) and the outer disc surface (12) are respectively fixed at both ends of the connecting portion (13), and the inner disc surface (11) Both the outer disk surface (12) and the outer disk surface (12) are provided with a blocking film (2), and the outer disk surface (12) is provided with a connection joint (3).
The left atrial appendage occluder according to claim 1, wherein the connecting portion (13) is a tubular structure having a lumen, and the connecting joint (3) is provided with a through hole, the connecting portion ( 13) Connected to the connecting joint (3), and the inner cavity of the connecting portion (13) communicates with the through hole of the connecting joint (3) to form a conveying passage.
A left atrial appendage occluder according to claim 2, wherein the delivery passage is provided with a one-way valve at an opening near one end of the inner disk surface (11).
A left atrial appendage occluder according to claim 3, wherein said one-way valve is a one-way diaphragm (131) that closes the opening of said delivery channel and can only be opened to the side of the inner disk (11). Composition.
The left atrial appendage occluder according to claim 2, wherein the connecting portion (13) is an elastic sleeve that is telescopic in length.
The left atrial appendage occluder according to claim 5, wherein said elastic sleeve is composed of a spring (132), an elastic membrane (133) and an end tube (134), said end tube (134) Fixed at a central position of the inner disk surface (11), one end of the spring (132) is connected to the end tube (134), and the other end of the spring (132) is connected to the connection joint (3), the elastic film (133) Covered on the outside of the spring (132), the two ends of the elastic film (133) are respectively connected with the end tube (134) and the connecting joint (3) to form a sleeve.
A left atrial appendage occluder according to claim 1, wherein said inner disc surface (11) is hemispherical with its flat end face facing the outer disc surface (12).
The left atrial appendage occluder according to claim 1, wherein a plurality of anchor thorns (14) are evenly disposed outside the largest circumferential surface of the inner disk surface (11), and the tip end of the anchor thorn (14) is oriented. One side of the outer disk (12).
A left atrial appendage occluder according to claim 1, wherein the shape memory wire for braiding the inner disk surface (11) is thicker than the shape memory wire for braiding the outer disk surface (12).
A left atrial appendage occluder according to claim 1 wherein said shape memory wire is a nickel titanium alloy wire.