CN204133530U - Occluder for left auricle - Google Patents

Abstract

The utility model provides a left atrial appendage occluder, which comprises an inner disc surface and an outer disc surface braided with shape-memory silk threads, the centers of the inner disc surface and the outer disc surface are connected through a connecting part, and the connecting part is a prefabricated rod , the inner disk surface and the outer disk surface are respectively fixed on the two ends of the connection part, the inner disk surface and the outer disk surface are provided with a flow blocking film, and the outer disk surface is provided with a connecting joint. Preferably, the connecting part is a tubular structure with a lumen, a through hole is provided in the connecting joint, the connecting part is connected with the connecting joint, and the inner cavity of the connecting part communicates with the through hole of the connecting joint, forming a delivery channel. The utility model is implanted from the outside of the left atrial appendage, which belongs to minimally invasive small incision surgery, and the doctor can look directly at the left atrial appendage, which not only simplifies the operation process, improves the safety of the operation, but also greatly reduces the pain of the patient . In addition, the utility model is provided with a conveying channel, which is convenient for injecting medicine or contrast agent into the human body during the operation.

Description

left atrial appendage occluder

technical field

The utility model relates to a medical device, in particular to an occluder used for occluding the left atrial appendage.

Background technique

Atrial fibrillation (AF) is one of the most common arrhythmias clinically, with an incidence rate of about 0.89% in the population, and the incidence rate increases with age. In addition to inducing and aggravating heart failure, atrial fibrillation can also cause stroke and other thrombotic events. About 5% of patients with atrial fibrillation suffer from stroke every year, and the mortality and disability rate caused by stroke is as high as 50%. Therefore, How to prevent or reduce stroke caused by thrombus in atrial fibrillation is of great significance. In recent years, a number of clinical studies have shown that closure of 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 occlusion. The operation process is complicated, and the interatrial septum needs to be punctured. It has certain radiation damage to both doctors and patients. In addition, during the operation of percutaneous puncture closure, it is necessary to determine the implantation position and closure effect of the occluder. In the prior art, this is achieved through X-ray or ultrasound imaging. During the operation, a However, for left atrial appendage surgical intervention, if a developing sheath is to be placed, a developing channel needs to be established. The developing channel must enter the right atrium from the venous puncture, and then puncture the interatrial septum into the left atrium. This method not only increases the complexity of the operation, but also increases the harm to the patient.

The Chinese patent No. ZL 200620068478.9 discloses a left atrial appendage occluder capable of automatic positioning in the left atrial appendage. The isolation membrane is characterized in that the support is formed by connecting a hollow disc-shaped sealing head and a hollow cylindrical positioning column, and the outer diameter of the disc-shaped sealing head is greater than the outer diameter of the cylindrical positioning column; Isolation membranes are installed in both the plug and the cylindrical positioning column; a transmission connector is installed on the side of the disc-shaped plugging head that is not connected with the cylindrical positioning column. This patent is to implant the occluder through the above-mentioned percutaneous puncture closure. Although it can also complete the closure, because the operation process is complicated and it is not convenient to determine 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 and the occlusion effect during the operation has become a technical problem to be solved urgently by those skilled in the art.

Utility model content

The technical problem to be solved by the utility model is to provide a left atrial appendage occluder that is punctured and implanted from the outside of the left atrial appendage, which can ensure the occluded position and occluded effect, so as to overcome the above-mentioned defects of the prior art.

In order to solve the above-mentioned technical problems, the utility model adopts the following technical scheme: a left atrial appendage occluder, including an inner disc and an outer disc braided with shape-memory wires, the centers of the inner disc and the outer disc are connected by a connecting part, The connecting part is a prefabricated rod, and the inner disc surface and the outer disc surface are respectively fixed at the two ends of the connecting part, the inner disc surface and the outer disc surface are provided with a flow blocking film, and the outer disc surface is provided with a connection connector.

Preferably, the connecting part is a tubular structure with a lumen, a through hole is provided in the connecting joint, the connecting part is connected with the connecting joint, and the inner cavity of the connecting part communicates with the through hole of the connecting joint, forming a delivery channel.

Further, the delivery channel is provided with a one-way valve at the opening near one end of the inner disk.

Further, the one-way valve is composed of a one-way diaphragm that closes the opening of the delivery channel and can only be opened to one side of the inner disk.

Further, the connecting part is an elastic sleeve with a stretchable length.

Further, the elastic sleeve is composed of a spring, an elastic film and an end pipe, the end pipe is fixed at the center of the inner disk, one end of the spring is connected to the end pipe, and the other end of the spring is connected to the connecting joint The elastic membrane is covered on the outside of the spring, and the two ends of the elastic membrane are respectively connected with the end pipe and the connecting joint to form a sleeve.

Preferably, the inner disk surface is hemispherical, and one side of the flat end surface faces the outer disk surface.

Preferably, a plurality of anchor thorns are evenly provided on the outer side of the largest circumferential surface of the inner disk, and the tips of the anchor thorns face to the side of the outer disk.

Preferably, the shape memory wires used to weave the inner disk are thicker than the shape memory wires used to weave the outer disk.

Preferably, said shape memory wire is Nitinol wire.

As mentioned above, the utility model left atrial appendage occluder has the following beneficial effects:

1. The utility model is implanted from the outside of the left atrial appendage, which belongs to minimally invasive small incision surgery, which not only simplifies the operation process, but also greatly reduces the pain of the patient.

2. This utility model is to implant the left atrial appendage occluder directly on the opening of the left atrial appendage, so the doctor can directly look at the left atrial appendage for surgical operation, which brings great convenience to the doctor's operation, shortens the operation time, and makes the operation process more convenient. Safety.

3. The utility model is equipped with a delivery channel, which is convenient for injecting medicine or contrast agent during the operation, and avoids damage to the human body caused by the use of additional catheters specially used for delivering medicine or contrast agent during the operation. The delivery channel is convenient for doctors to operate, and to observe whether the position of the occluder is in place and whether the operation is successful, which further reduces the injury to the patient, reduces the difficulty of the operation, and further improves the safety of the operation.

Description of drawings

Fig. 1 is a schematic diagram of the first embodiment of the present utility model.

Fig. 2 is a schematic diagram of a second embodiment of the present invention.

Fig. 3 is a schematic diagram of a third embodiment of the present invention.

Fig. 4 is a schematic diagram of a fourth embodiment of the present invention.

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

Fig. 6 is a working principle diagram of the utility model.

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

13 Connecting part 131 One-way diaphragm

132 spring 133 elastic film

14 anchor thorns 2 flow blocking film

3 Connecting joint 4 Left atrial appendage

5 left atrium

Detailed ways

The structures, proportions, sizes, etc. shown in the accompanying drawings of the description are only used to cooperate with the content disclosed in the description, for those who are familiar with this technology to understand and read, and are not used to limit the limited conditions that the utility model can be implemented, so It has no technical substantive meaning, and any modification of structure, change of proportional relationship or adjustment of size shall still fall within the scope of the disclosure of this utility model without affecting the functions and objectives of this utility model. within the range covered by the technical content. 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 practicable scope of the present utility model. The change or adjustment of the relative relationship between the range and the technical content shall also be regarded as the implementable scope of the present utility model without substantive changes in the technical content.

As shown in Figure 1, it is a left atrial appendage occluder of the present invention, which includes an inner disk surface 11 and an outer disk surface 12 braided with shape-memory silk thread, and the inner disk surface 11 and the outer disk surface 12 are connected by a connecting part 13, and the The connecting part 13 is a prefabricated rod, and the inner disk surface 11 and the outer disk surface 12 are respectively fixed on two ends of the connecting part 13 . The so-called prefabricated rod means that the connecting part 13 is a separately manufactured component, and is not braided with shape-memory wire together with the inner disk surface 11 and the outer disk surface 12, and the surface of the connecting part 13 does not have meshes. Both the inner disk surface 11 and the outer disk surface 12 are provided with a flow blocking film 2 , and the outer disk surface 12 is provided with a connecting 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 Figure 2, in a preferred embodiment of the present utility model, the connecting part 13 is a tubular structure with an inner cavity, and a through hole is provided in the connecting joint 3, and the connecting part 13 is connected to the connecting joint 3. connected, and the lumen of the connecting part 13 communicates with the through hole of the connecting joint 3 to form a delivery channel, which can be used to deliver contrast agents or drugs. Furthermore, the delivery channel is provided with a one-way valve at the end close to the inner disc surface 11, so that the contrast agent will not flow back, and at the same time, blood is prevented from flowing out of the left atrial appendage from the delivery channel. As shown in FIG. 5 , a one-way valve with the simplest structure is composed of a one-way diaphragm 131 that is used to close the opening of the delivery channel and can only be opened toward the inner disk side. In this embodiment, the flow blocking membrane 2 is made of polymer materials 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 connection part 13 described in the utility model are all independent structures, and the three are formed into a whole by laser welding during use. The connecting part 13 of this device is much thinner than the middle part of the conventional LAA occluder, and it does not need to be stretched when the LAA is implanted, which can minimize the opening at the LAA during surgery and speed up the healing of the opening speed and reduce patient pain.

In this embodiment, the connecting part 13 is an elastic sleeve whose length can be stretched and contracted, and it can be implemented in various ways, such as the bellows structure shown in FIG. 3 . In a preferred mode of this embodiment, as shown in Figures 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 pipe 134, the other end of the spring 132 is connected to the connecting joint 3, the elastic film 133 is covered outside the spring 132, and the two ends of the elastic film 133 are respectively connected to the end pipe 134, The connection joints 3 are connected to form a casing. The connecting part 13 in this embodiment has the performance of elastic expansion and contraction, so the inner disk surface 11 and the outer disk surface 12 can clamp the left atrial appendage through the 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 utility model is punctured and implanted from the outside of the left atrial appendage during the operation, so the design of two disks is adopted. The inner disk 11 is used to support the inside of the left atrial appendage to prevent blood from entering the cavity of the left atrial appendage to form a thrombus, thereby preventing blood vessels The function of embolism; the outer disc surface 12 plays a position-limiting role on the outside of the left atrial appendage, preventing the device from falling off and entering 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 occupied area in the human body and avoid interfering with other tissues or organs of the human body. Therefore, it needs to be slightly larger, so that the entire left atrial appendage can be blocked and supported in it. In addition, because the inner disc surface 11 in this device is to ensure a stable support effect in the left atrial appendage, the diameter of the nickel-titanium alloy wire braided on the inner disc surface 11 is relatively thick to ensure good supporting capacity; while the outer disc surface 12 is outside the left atrial appendage , so the diameter of the nickel-titanium alloy wire braided on the outer disk surface 12 is thinner to reduce the hardness and prevent damage to human tissue. Further, through the test and verification of the utility model, the diameter of the nickel-titanium alloy wire braiding the inner disk 11 in this device is 0.11mm-0.20mm, and the diameter of the nickel-titanium alloy wire braiding the outer disk 12 is 0.01mm-0.10mm. The diameters of the inner disk surface 11 and the outer disk surface 12 within this range are optimum diameters.

As shown in FIG. 1 , 2 , 3 or 4 , the inner disk surface 11 in this embodiment is hemispherical, and one side of its flat end surface faces the outer disk surface 12 . The hemispherical design of the inner disk 11 facilitates its expansion and release: when the inner disk 11 is implanted into the left atrial appendage, it will be directly stretched like an umbrella; The protruding shape can increase the surface tension of the inner disc surface 11 and prevent it from being depressed and thus forming a thrombus due to blood pressure. Therefore, the hemispherical surface design of the device can effectively ensure the blocking effect and prevent thrombus formation.

In this embodiment, a plurality of anchor thorns 14 are evenly provided on the outer side of the largest circumferential surface of the inner disk 11 , and the tips of the anchor thorns 14 face the side of the outer disk 12 . The anchor thorn 14 can assist the positioning of the device in the left atrial appendage and prevent it from slipping out of the left atrial appendage; at the same time, because the anchor thorn 14 is also made of nickel-titanium alloy and has good bending performance, it will not affect the release and recovery of the device.

As shown in Figures 3, 4, and 5, the implementation method of the utility model during surgery is: after cutting out a small incision in the patient's left intercostal space, then cutting out the opening of the left atrial appendage 4, using ultrasonic guidance, and then transporting the The sheath tube is implanted in the left atrial appendage 4, and then the connection joint 3 of the device is connected with the delivery tool, and is sent into the left atrial appendage 4 from the outside of the left atrial appendage 4 through the delivery sheath tube; the inner disk 11 of the device is released from the delivery sheath tube 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 the delivery sheath is pulled back to the outside of the left atrial appendage 4, so that the outer disk surface 12 is stuck on the inner wall of the left atrial appendage 4. The opening outside the left atrial appendage 4 cut out. The choke membrane 2 in the inner disk surface 11 can effectively prevent blood from entering the left atrial appendage 4, and the choke membrane 2 in the outer disk surface 12 can prevent the oozing blood from flowing out. Because the outer disc surface 12 is stuck in the opening, the two ends of the device clamp the left atrial appendage in the middle, so that the device will neither slide into the left atrium 5 nor fall off from 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 and whether the defect is completely blocked is determined by the contrast agent. After confirmation, the delivery sheath is withdrawn to complete the closure of the left atrial appendage device installation.

To sum up, the utility model is a left atrial appendage occluder, which can solve the problems of inconvenient determination and inaccurate positioning when occluding the left atrial appendage. Therefore, the utility model 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 utility model, and are not intended to limit the present utility model. There are many aspects of this utility model 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 this utility model. Therefore, all equivalent modifications or changes made by those with ordinary knowledge in the technical field without departing from the spirit and technical ideas disclosed in the utility model should still be covered by the claims of the utility model.

Claims (10)

1. an occluder for left auricle, it is characterized in that: comprise the interior card (11) with the braiding of shape memory silk thread and outer card (12), described interior card (11) is connected by connecting portion (13) with the center of outer card (12), described connecting portion (13) is a prefabricated bar, described interior card (11) and outer card (12) are separately fixed at the two ends of connecting portion (13), choked flow film (2) is equipped with in described interior card (11) and outer card (12), described outer card (12) is provided with jointing (3).

2. occluder for left auricle according to claim 1, it is characterized in that: described connecting portion (13) is the tubular structure with inner chamber, described jointing is provided with through hole in (3), described connecting portion (13) is connected with jointing (3), and the through hole of the inner chamber of connecting portion (13) and jointing (3) communicates, form a transfer passage.

3. occluder for left auricle according to claim 2, is characterized in that: described transfer passage is provided with check valve at the opening part near interior card (11) one end.

4. occluder for left auricle according to claim 3, is characterized in that: described check valve is by the opening closing described transfer passage and can only membrane (131) that inwardly card (11) side is opened form.

5. occluder for left auricle according to claim 2, is characterized in that: described connecting portion (13) is the spring-backed quill that a length can be stretched.

6. occluder for left auricle according to claim 5, it is characterized in that: described spring-backed quill is by a spring (132), elastica (133) and end pipe (134) composition, described end pipe (134) is fixed on the center of interior card (11), one end of described spring (132) is managed (134) with end and is connected, the other end of spring (132) is connected with jointing (3), described elastica (133) is coated on spring (132) outside, the two ends of elastica (133) are managed (134) with end respectively, jointing (3) is connected, form a sleeve pipe.

7. occluder for left auricle according to claim 1, is characterized in that: described interior card (11) is for hemispherical, and its planar end surface side is card (12) toward the outside.

8. occluder for left auricle according to claim 1, it is characterized in that: outside the greatest circle side face of described interior card (11), be evenly provided with multiple anchor thorn (14), card (12) side toward the outside, tip of described anchor thorn (14).

9. occluder for left auricle according to claim 1, is characterized in that: the shape memory silk thread for weaving interior card (11) is thicker than the shape memory silk thread for weaving outer card (12).

10. occluder for left auricle according to claim 1, is characterized in that: described shape memory silk thread is nitinol alloy wire.