A double-layer left atrial appendage occluder

Abstract

The application relates to the field of occluders, in particular to a double-layer left atrial appendage occluder, which comprises a conveying pipe, a pushing structure and an occlusion structure, the conveying pipe is internally provided with a pushing steel cable, the left end of the pushing steel cable is provided with a pushing head, the upper end of the conveying pipe is provided with a liquid injection pipe, the right end of the conveying pipe is connected with the pushing structure for sending the occluder, and the pushing structure is internally placed with the occlusion structure. The specification of the occluder is selected, the sheath tube mark position is flush with the left atrial appendage opening, whether the conveying steel cable is connected with the conveyor is checked, the barb is safe, stable, easy to recycle, not easy to fall off in the implantation process; the barb can be recycled and unfolded repeatedly, the barb does not deform, the hook-shaped distal end reduces the risk of damaging the atrial wall, the opening design makes the occlusion more stable, the porosity and thickness are moderate, the thrombus overflow is effectively prevented, the weaving mode is beneficial to endothelial cell proliferation, the endothelialization process is accelerated, and the use effect of the occluder is improved.

Description

Technical Field

[0001] This invention relates to the field of occluders, specifically a double-layer left atrial appendage occluder. Background Technology

[0002] Currently, occluders can be placed in the left atrial appendage (LAA) via catheter intervention to prevent thrombus formation in the LA due to atrial fibrillation, thus avoiding the risk of stroke caused by the thrombus ascending to the brain; or to prevent the thrombus from reaching other parts of the body through the circulatory system, causing systemic embolism. These LA occluders can be broadly categorized into integrated and separate types. For example, a separate occluder typically includes a fixing component and a sealing component that are connected to each other. The fixing component is placed in the LA cavity to secure the entire occluder, while the sealing component seals the opening of the LA to block blood flow into the LA cavity.

[0003] The existing occluder consists of an occluder body including a fixing plate, the occluder body being fixed to the left atrial appendage orifice via the fixing plate, and a sensor including a pressure sensor, which is mounted on the fixing plate. A fixing anchor is provided between the hook-shaped part and the main body, and the pressure sensor is mounted on the fixing anchor.

[0004] However, the hook-shaped part of the existing occluder has an open structure, which poses a risk of hook damage to the left atrial appendage wall during the process of entering the left atrial appendage. In addition, the barbs cannot be directly pulled out after implantation and require open surgery to remove them, which increases the risk of replacement and follow-up examination. Furthermore, the existing left atrial appendage occluder only has a single-layer occlusion structure, which reduces the occlusion effect. Moreover, the existing left atrial appendage occluder needs to be placed deep inside the left atrial appendage, which also brings trouble to replacement and follow-up examination. Summary of the Invention

[0005] The purpose of this invention is to provide a double-layer left atrial appendage occluder to address the problems of existing occluders having an open hook structure, which poses a risk of hook damage to the left atrial appendage wall during insertion. Furthermore, the barbs cannot be directly pulled out after implantation, requiring open surgery for removal, increasing the risk of replacement and follow-up examinations. In addition, existing left atrial appendage occluders only have a single-layer occlusion structure, reducing the occlusion effect. Moreover, existing left atrial appendage occluders need to be placed deep within the left atrial appendage, which also brings trouble to replacement and follow-up examinations.

[0006] Therefore, the present invention provides a double-layer left atrial appendage occlusion device, comprising a delivery tube, a pushing structure, and an occlusion structure. The delivery tube is provided with a pushing steel cable inside, and a pusher head is installed at the left end of the pushing steel cable. An injection tube is provided at the upper end of the delivery tube, and the right end of the delivery tube is connected to the pushing structure for delivering the occluder. The occlusion structure is placed inside the pushing structure.

[0007] Preferably, the pushing structure includes a hemostatic valve, the right end of which is connected to a guide sheath, the upper end of which is equipped with a tee, the right end of which is connected to a Luer connector, and the right end of which is connected to an expansion tube.

[0008] Preferably, the sealing structure includes a flow-blocking membrane, a proximal inner pin is installed inside the center of the flow-blocking membrane, a proximal outer pin is installed at the upper end of the proximal inner pin, and a sealing device bracket is provided at the lower end of the flow-blocking membrane.

[0009] Preferably, the distal end of the guide sheath has four sets of marking rings in sequence.

[0010] Preferably, the working length of the guide sheath is at least seventy-six centimeters.

[0011] Preferably, the guide sheath marking is aligned with the opening of the left atrial appendage.

[0012] Preferably, the occluder support has a barbed structure.

[0013] Preferably, the diameter of the opening of the occluder bracket is between 14 mm and 32 mm.

[0014] Preferably, the occluder support material has a gradually increasing hardness from near to far.

[0015] Compared with the prior art, the beneficial effects of the present invention are:

[0016] This invention involves selecting the appropriate occluder specification, aligning the sheath marking with the left atrial appendage opening, checking the tightness of the connection between the delivery cable and the delivery device, aligning the occluder with the distal marking ring of the inner sheath, and slowly inserting the inspected, purged, and pre-installed occluder delivery device into the guide sheath of the delivery system. Connect the dilator tube to the right end of the guide sheath using a Luer connector. During the insertion process, heparinized saline should be continuously injected to prevent gas from entering the delivery system. Align the distal marking ring of the delivery tube with the distal marking ring of the guide sheath, fix the delivery tube, retract the guide sheath to engage with the delivery tube, and then completely fix the delivery system so that it cannot advance further. Push the pusher head to move the pusher cable to the right, pushing the guide sheath and the occluder inside the dilator tube into the left atrial appendage. Fix the pusher cable of the occluder and slowly retract the delivery cable. The delivery system's sheath allows the occluder to slowly and gradually unfold from distal to proximal within the left atrial appendage (LAA) until it is fully opened. The barbed structure formed by the choke membrane and the occluder support creates a double-layer structure: one layer seals the external opening, and the other supports the inner side of the left atrial appendage. The inner side provides support and secondary occlusion, positioned relatively shallowly within the left atrial appendage. Unlike existing occluders that directly cover the outside of the left atrial appendage, this structure is more stable and does not cause damage. The barbs are safe, stable, easy to retrieve, and not easily dislodged during implantation; they can be repeatedly retrieved and unfolded without deformation. The hook-shaped distal end reduces the risk of damage to the atrial appendage wall. The opening design enhances occlusion stability, and the moderate porosity and thickness effectively prevent thrombus leakage. The braided design promotes endothelial cell proliferation, accelerates endothelialization, and improves the occluder's effectiveness. Attached Figure Description

[0017] Figure 1 This is a front cross-sectional view of the sealing structure of the present invention;

[0018] Figure 2 This is a bottom view of the sealing structure of the present invention;

[0019] Figure 3 This is a front view of the sealing structure of the present invention;

[0020] Figure 4 This is a top view of the sealing structure of the present invention;

[0021] Figure 5 A three-dimensional structural view of the present invention is provided.

[0022] In the picture:

[0023] 1. Delivery tube; 2. Push cable; 3. Push head; 4. Injection tube; 501. Hemostatic valve; 502. Tee; 503. Guide sheath; 504. Luer connector; 505. Dilatation tube; 601. Flow dam; 602. Occluder support; 603. Proximal internal pin; 604. Proximal external pin. Detailed Implementation

[0024] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0025] Example 1

[0026] Please see Figure 1-5 The figure shows a preferred embodiment of the present invention, a double-layer left atrial appendage occluder, including a delivery tube 1, a pushing structure and an occlusion structure. The delivery tube 1 is provided with a pushing steel cable 2 inside, and a push head 3 is installed at the left end of the pushing steel cable 2. The upper end of the delivery tube 1 is provided with an injection tube 4, and the right end of the delivery tube 1 is connected to the pushing structure for sending the occluder in. The occlusion structure is placed inside the pushing structure.

[0027] It should be noted that the push and blockage structures in this solution improve the safety and convenience of using the blocker.

[0028] The push structure includes a hemostatic valve 501, the right end of which is connected to a guide sheath 503. A three-way valve 502 is installed at the upper end of the guide sheath 503. The right end of the guide sheath 503 is connected to a Luer connector 504, and the right end of the Luer connector 504 is connected to an expansion tube 505.

[0029] It should be noted that this solution facilitates the more convenient delivery of the occluder.

[0030] The distal end of the guide sheath 503 has four sets of marking rings in sequence.

[0031] It should be noted that this method makes the insertion of the occluder more standardized.

[0032] The working length of the guide sheath 503 is at least seventy-six centimeters.

[0033] It should be noted that this solution facilitates more precise operation.

[0034] The guide sheath 503 is positioned flush with the opening of the left atrial appendage.

[0035] It should be noted that this solution provides more precise alignment.

[0036] Example 2

[0037] Please see Figure 1-5The sealing structure includes a flow-blocking membrane 601, a proximal inner pin 603 installed inside the center of the flow-blocking membrane 601, a proximal outer pin 604 installed at the upper end of the proximal inner pin 603, and a sealing device bracket 602 provided at the lower end of the flow-blocking membrane 601.

[0038] It should be noted that this solution provides a safer and more stable blocking method.

[0039] The occluder bracket 602 has a barbed structure.

[0040] It should be noted that this solution ensures safety, stability, easy retrieval, and minimal risk of detachment during implantation; it allows for repeated retrieval and deployment, and the barbs do not deform.

[0041] The diameter of the opening of the occluder bracket 602 is between 14 mm and 32 mm.

[0042] It should be noted that this design is suitable for wide and shallow auricle shapes; it is also suitable for multi-lobed auricles.

[0043] The occluder bracket 602 is made of a material with a gradually changing hardness from near to far.

[0044] It should be noted that this solution is adaptable to various atrial appendage morphologies while reducing distal atrial appendage damage.

[0045] The workflow and principle of this invention are as follows: Align the sheath marking position with the left atrial appendage opening. Check that the delivery cable and delivery device are tightly connected. Align the occluder with the distal marking ring of the inner sheath. Slowly insert the inspected, vented, and pre-installed occluder delivery device into the guide sheath 503 of the delivery system. Connect the expansion tube 505 to the right end of the guide sheath 503 via the Luer connector 504. During the pushing process, continuously inject heparinized saline to prevent gas from entering the delivery system. Align the distal marking ring of the delivery tube 1 with the distal marking ring of the guide sheath 503, fix the delivery tube 1, retract the guide sheath 503 to engage with the delivery tube 1, and then completely fix the delivery system so that the entire delivery system cannot move forward. Push the pusher 3 to push the push cable 2 to the right, pushing the guide sheath 503 and causing the occluder in the expansion tube 505 to enter the left atrial appendage. The push cable 2 of the fixed occluder is slowly withdrawn from the sheath of the delivery system, allowing the occluder to gradually unfold from distal to proximal within the LAA until it is fully opened. The barbed structure formed by the flow-blocking membrane 601 and the occluder support 602 is a double-layer structure, with one layer sealing the outer opening and the other supporting the inner side of the left atrial appendage. The inner side of the left atrial appendage provides support and secondary occlusion, and is located in a shallower position within the left atrial appendage. This structure is different from existing occluders that directly cover the outside of the left atrial appendage, making it more stable and preventing damage to the left atrial appendage. The barbs are safe, stable, easy to retrieve, and not easily dislodged during implantation; they can be repeatedly retrieved and unfolded without deformation. The hook-shaped distal end reduces the risk of damage to the atrial appendage wall; the opening design makes the occlusion more stable; the porosity and thickness are moderate, effectively preventing thrombus leakage; and the weaving method is conducive to endothelial cell proliferation and accelerates the endothelialization process.

[0046] The above description, in conjunction with specific embodiments, provides a further detailed explanation of the present invention. It should not be construed that the specific implementation of the present invention is limited to these descriptions. For those skilled in the art, several simple deductions or substitutions can be made without departing from the concept of the present invention, and all such deductions or substitutions should be considered to fall within the scope of protection defined by the claims submitted herein.

Claims

1. A double-layer left atrial appendage occlusion device, characterized in that: It includes a delivery pipe (1), a pushing structure and a sealing structure. The delivery pipe (1) is equipped with a pushing steel cable (2). A push head (3) is installed at the left end of the pushing steel cable (2). An injection pipe (4) is installed at the upper end of the delivery pipe (1). The right end of the delivery pipe (1) is connected to a pushing structure that sends the sealing device in. The sealing structure is placed inside the pushing structure. The push structure includes a hemostatic valve (501), the right end of which is connected to a guide sheath (503), a tee (502) is installed at the upper end of the guide sheath (503), the right end of which is connected to a Luer connector (504), and the right end of which is connected to an expansion tube (505). The blocking structure includes a flow-blocking membrane (601), a proximal inner pin (603) is installed inside the center of the flow-blocking membrane (601), a proximal outer pin (604) is installed on the upper end of the proximal inner pin (603), and a blocker bracket (602) is provided at the lower end of the flow-blocking membrane (601). The blocker bracket (602) is made of a material with a gradually changing hardness from proximal to distal.

2. The double-layer left atrial appendage occlusion device according to claim 1, characterized in that: The distal end of the guide sheath (503) has four sets of marking rings in sequence.

3. The double-layer left atrial appendage occlusion device according to claim 1, characterized in that: The working length of the guide sheath (503) is at least seventy-six centimeters.

4. A double-layer left atrial appendage occlusion device according to claim 1, characterized in that: The guide sheath (503) is marked at the same level as the opening of the left atrial appendage.

5. A double-layer left atrial appendage occlusion device according to claim 1, characterized in that: The occluder bracket (602) has a barbed structure.

6. A double-layer left atrial appendage occlusion device according to claim 1, characterized in that: The opening diameter of the occluder bracket (602) is between 14 mm and 32 mm.

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