A novel left atrial appendage occluder and its deployment method

Abstract

The present invention discloses a novel left atrial appendage occluder and a deployment method, comprising an occluding disk for occluding, an anchoring cup for anchoring the position of the left atrial appendage occluder, and a connecting rib for connecting the anchoring cup and the occluding disk. The anchoring cup is a hemispherical double-layer structure, comprising an outer shrinkage anchoring layer and an inner support layer. The distal end of the shrinkage anchoring layer is converged by a distal cluster tube, the proximal end of the support layer is connected to the proximal end of the shrinkage anchoring layer, and the distal end is connected to the connecting rib. The weaving density at the connection between the proximal end of the shrinkage anchoring layer and the support layer is greater than the weaving density between the shrinkage anchoring layer and the support layer. An anchor hook with an end protruding from the surface of the shrinkage anchoring layer is provided on the shrinkage anchoring layer. The present invention uses an anchoring cup with a double-layer structure, which can adapt to left atrial appendage walls of different inner diameters in combination with the anchor hook, and the occluding disk can fit tightly with the left atrial appendage opening, thereby achieving a good occluding effect and reducing the thrombus overflow rate.

Description

Technical Field

[0001] The present invention relates to the technical field of left atrial appendage occluder, and in particular to a novel left atrial appendage occluder and a deployment method thereof. Background Art

[0002] Currently, LAA occluders can be broadly categorized as braided, cut, and hybrid types. All of these devices can be delivered into the LAA via catheterization to achieve LAA occlusion. However, they all have significant limitations. Due to the complex anatomy of the LAA and its diverse shapes, ranging from cauliflower to weather vane, the LAA's inner wall is uneven and irregular, and its walls are thin. This makes it difficult to achieve the desired occlusion effect while simultaneously securing the device securely within the LAA without puncturing the heart wall.

[0003] Invention patent CN102805654A relates to a left atrial appendage occluder comprising an elastic closure disc, a fixing frame connected to the closure disc and located on one side of the closure disc, the fixing frame comprising a central end connected to the closure disc and a plurality of interconnected and curved support rods, at least one of which has at least one anchoring spike disposed near the end of at least one support rod, the anchoring spike facing the closure disc. This design has the advantage of being structurally stable, but lacks adaptability to the left atrial appendage and cannot perfectly fit the walls of the left atrial appendage of different shapes to achieve the desired occlusion effect.

[0004] The left atrial appendage occluder tried and claimed by patent of invention CN101146570A belongs to a braided left atrial appendage occluder. Mainly, the uneven structure of the fixed disk surface of the occluder is used to anchor the occluder, and the occluding disk blocks the left atrial appendage orifice to achieve the effect of occlusion. Its advantages are simple structure, low processing difficulty and low cost. However, the anchoring strength of the braided fixed disk is low, which makes it difficult to adapt to the left atrial appendage forms of various shapes. Even if the anchoring hook is sutured on the fixed disk, it is still difficult to penetrate into the left atrial appendage wall when the fixed disk is subjected to extrusion deformation to achieve stable fixation. Moreover, the fixed disk will affect the shape of the occluding disk after being subjected to extrusion deformation in the left atrial appendage, resulting in poor blocking effect.

[0005] It is difficult to ensure the compatibility of today's left atrial appendage occluders with various types of left atrial appendages, resulting in poor occlusion effects. At the same time, due to the stress and deformation of the occluder itself, some thrombi can easily enter the blood circulation through the gaps, creating the risk of vascular embolism. Summary of the Invention

[0006] Technical purpose: In view of the shortcomings that existing left atrial appendage occluders cannot ensure the fit with various types of left atrial appendages, require anchor hooks to pierce the heart wall for fixation, have poor sealing effect, and the sealing between the occluding disc and the left atrial appendage opening is prone to thrombus overflow due to deformation, the present invention discloses a new left atrial appendage occluder and deployment method that can better fit the left atrial appendage wall, maintain the sealing effect of the occluding disc, and reduce the thrombus overflow rate.

[0007] Technical solution: To achieve the above technical objectives, the present invention adopts the following technical solution:

[0008] A novel left atrial appendage occluder comprises an occluding disk for occlusion, an anchoring cup for anchoring the position of the left atrial appendage occluder, and a connecting rib for connecting the anchoring cup and the occluding disk. The anchoring cup is a hemispherical double-layer structure, comprising an outer shrinkage anchoring layer and an inner support layer. The distal end of the shrinkage anchoring layer is contracted by a distal bundle tube, the proximal end of the support layer is connected to the proximal end of the shrinkage anchoring layer, and the distal end is connected to the connecting rib. A space for the shrinkage anchoring layer to be compressed and deformed is formed between the shrinkage anchoring layer and the support layer. The braiding density at the connection between the proximal end of the shrinkage anchoring layer and the support layer is greater than the braiding density between the shrinkage anchoring layer and the support layer. An anchor hook with an end protruding from the surface of the shrinkage anchoring layer is provided on the shrinkage anchoring layer.

[0009] Preferably, the connecting rib of the present invention adopts a truncated cone structure, with the end with a smaller diameter connected to the distal end of the support layer and the other end connected to the distal end of the occluding disk. When the anchor cup is unfolded, the occluding disk is pulled closer to the side where the anchor cup is located through the connecting rib.

[0010] Preferably, the occluding disc of the present invention adopts a double-layer ring disc structure, including an inner disc connected to the connecting rib and an outer disc located at the proximal end. The curvature of the disc surface near the distal end of the outer disc is greater than the curvature of the disc surface near the proximal end. When blood flows through the outer disc, a pressure difference is formed on both sides of the outer disc, pressing the occluding disc tightly against the ear opening of the left atrial appendage; the proximal end of the outer disc is converged by the proximal bundling tube.

[0011] Preferably, the anchor hook of the present invention includes two groups of hooks with a height difference, a connecting rod is set between the two groups of hooks for connection, the hooks and the connecting rod are integrally formed and evenly distributed on the anchor cup, and the end of the hook faces the side where the sealing disk is located.

[0012] Preferably, the occluding disk, connecting rib and anchoring cup of the present invention are integrally woven, and the weaving density of the occluding disk is less than that of the anchoring cup and the connecting rib; the deformation capacity of the occluding disk is less than that of the anchoring cup and the connecting rib.

[0013] Preferably, the expanded diameter of the occluder disk of the present invention is larger than the expanded diameter of the anchoring cup.

[0014] The present invention also discloses a deployment method based on the novel left atrial appendage occluder, comprising the steps of:

[0015] S01, the contracted left atrial appendage occluder is released after being delivered to the position by the guidewire, with the anchoring cup located inside the left atrial appendage and the occlusion disc located at the left atrial appendage opening;

[0016] S02. As the left atrial appendage occluder is deployed, the contracted anchoring layer of the anchoring cup contacts the left atrial appendage wall and deforms as the left atrial appendage wall. During the deployment process, the connecting ribs pull the occlusion disc toward the side where the anchoring cup is located, so that the occlusion disc fits at the left atrial appendage opening.

[0017] S03. When blood flows through the outer disc of the occlusion disc, a pressure difference is formed on both sides of the disc surface of the outer disc, applying pressure toward the inside of the left atrial appendage on the occlusion disc; when the left atrial appendage occluder is deformed by force, the deformation amplitude of the occlusion disc is smaller than the deformation amplitude of the connecting ribs and the anchoring cup.

[0018] Beneficial effects: The novel left atrial appendage occluder and deployment method provided by the present invention have the following beneficial effects:

[0019] 1. The anchoring cup of the present invention adopts a double-layer structure design. The shrinkage anchoring layer can shrink toward the support layer side, and the maximum shrinkage rate can reach 30%-40%. It can better adapt to the left atrial appendage wall with different inner diameters and shapes, and improve the fixation effect of the anchoring cup.

[0020] 2. The anchor hook of the present invention includes two groups of hooks with a height difference, and is evenly distributed in the circumferential direction of the anchor cup, which reduces the phenomenon of loose wall hanging caused by unfavorable factors such as the uneven inner wall of the left atrial appendage, irregular shape, and thin left atrial appendage wall, so that the anchor cup can better fit the inner wall of the left atrial appendage, reduce the occluder shedding rate and the occurrence of adverse reactions such as pericardial effusion.

[0021] 3. The connecting ribs of the present invention adopt a truncated cone structure. When the anchor cup is unfolded, the connecting ribs can apply a pulling force toward the anchor cup to the occluding disc, thereby improving the sealing effect of the occluding disc and reducing the overflow rate of thrombus.

[0022] 4. The occluding disk of the present invention adopts a double-layer disc-shaped structure, and the curvature of the disk surface at the distal end of the outer disk is greater than the curvature of the disk surface at the proximal end. Due to the difference in curvature, a pressure difference will be formed on both sides of the disk surface when blood flows through, providing reverse lift to the occluding disk, so that the occluding disk can be pressed into place, and the inner disk can play a role of radial support, thereby reducing the stress deformation of the occluding disk, making the occluding disk less affected by the degree of freedom and not easy to fall off, and can reduce the phenomenon of incomplete endothelialization caused by poor wall adhesion.

[0023] 5. The present invention adopts an encrypted weaving process at the connection between the contraction anchoring layer and the support layer to improve the structural strength of the junction, and the deformation ability of the occluder is minimized, which can maintain the fit between the occluder and the left atrial appendage opening and reduce the risk of the occluder disc wearing or wearing the left atrial appendage opening. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for describing the embodiments or the prior art.

[0025] Figure 1 This is a diagram showing the overall structure of the left atrial appendage occluder of the present invention;

[0026] Figure 2 This is a top view of the left atrial appendage occluder of the present invention;

[0027] Figure 3 This is a bottom view of the left atrial appendage occluder of the present invention;

[0028] Figure 4 This is a schematic diagram of the anchor hook structure of the left atrial appendage occluder of the present invention;

[0029] Among them, 1-occluding disc, 2-anchoring cup, 3-connecting rib, 4-contraction anchoring layer, 5-supporting layer, 6-distal cluster tube, 7-anchor hook, 8-inner disc, 9-outer disc, 10-proximal cluster tube, 11-connecting rod. DETAILED DESCRIPTION

[0030] The present invention will be described more clearly and completely below by way of a preferred embodiment in conjunction with the accompanying drawings, but the present invention is not limited to the scope of the embodiment.

[0031] like Figures 1-4 The figure shows a new type of left atrial appendage occluder disclosed in the present invention, including an occluding disk 1 for occluding, an anchoring cup 2 for anchoring the position of the left atrial appendage occluder and a connecting rib 3 for connecting the anchoring cup 2 and the occluding disk 1. The anchoring cup 2 is a hemispherical double-layer structure, including an outer shrinkage anchoring layer 4 and an inner support layer 5. The distal end of the shrinkage anchoring layer 4 is converged by a distal bundle tube 6, the proximal end of the support layer 5 is connected to the proximal end of the shrinkage anchoring layer 4, and the distal end is connected to the connecting rib 3. A space is formed between the shrinkage anchoring layer 4 and the support layer 5 for the shrinkage anchoring layer 4 to be compressed and deformed. The weaving density at the connection between the proximal ends of the shrinkage anchoring layer 4 and the support layer 5 is greater than the weaving density of the shrinkage anchoring layer 4 and the support layer 5. The shrinkage anchoring layer 4 is provided with an anchor hook 7 whose end protrudes from the surface of the shrinkage anchoring layer 4.

[0032] In order to make the connecting rib 3 and the anchoring cup 2 compatible with stress deformation, reduce the impact on the occluding disc 1, and ensure the occluding effect, the connecting rib 3 of the present invention adopts a truncated cone structure, and the weaving distribution is a circumferential radial distribution. The end with a smaller diameter is connected to the distal end of the support layer 5, and the other end is connected to the distal end of the occluding disc 1. When the anchoring cup 2 is unfolded, the occluding disc 1 is pulled toward the side where the anchoring cup 2 is located through the connecting rib 3; the occluding disc 1 adopts a double-layer annular disc structure, including an inner disc 8 connected to the connecting rib 3 and an outer disc 9 located at the proximal end. The curvature of the disc surface of the outer disc 9 near the distal end is greater than the curvature of the disc surface near the proximal end. When blood flows through the outer disc 9, a pressure difference is formed on both sides of the outer disc 9, pressing the occluding disc 1 tightly against the ear opening of the left atrial appendage; the proximal end of the outer disc 9 is converged by the proximal bundling tube 10. When the occluding disc is subjected to force away from the connecting rib 3, on the one hand, it will be subjected to the pulling force of the truncated cone-shaped connecting rib 3, and at the same time, the side of the occluding disc 1 away from the connecting rib will be affected by the reverse lift force caused by the pressure difference caused by the blood flow rate, so that the occluding disc can always be closely attached to the position of the left atrial appendage opening, ensuring the occluding effect and avoiding the problem of thrombus overflow.

[0033] In order to make the anchor hook 7 compatible with the deformation of the anchor cup and firmly anchor the left atrial appendage occluder, the anchor hook 7 of the present invention includes two groups of hooks with a height difference, and a connecting rod 11 is provided between the two groups of hooks for connection. The hook 7 and the connecting rod 11 are integrally formed and evenly distributed on the anchor cup 2, with the end of the hook facing the side where the occlusion disk 1 is located; and preferably, the anchor hook uses an asymmetrically distributed structure on the anchor cup.

[0034] The occluding disk 1, connecting rib 3 and anchoring cup 2 of the present invention are formed by integral weaving, and the weaving density of the occluding disk 1 is less than the weaving density of the anchoring cup 2 and the connecting rib 3; the deformation capacity of the occluding disk 1 is less than the deformation capacity of the anchoring cup 2 and the deformation capacity of the connecting rib 3, and the expansion diameter of the occluding disk 1 is greater than the expansion diameter of the anchoring cup; through the integral weaving molding process, the complexity of the process is reduced, and at the same time, the deformation capacity can be flexibly controlled through the weaving density, eliminating processes such as welding.

[0035] The present invention also provides a deployment method based on the novel left atrial appendage occluder structure, comprising the steps of:

[0036] S01, the contracted left atrial appendage occluder is released after being delivered to the position by the guidewire, with the anchoring cup located inside the left atrial appendage and the occlusion disc located at the left atrial appendage opening;

[0037] S02. As the left atrial appendage occluder is deployed, the contracted anchoring layer of the anchoring cup contacts the left atrial appendage wall and deforms as the left atrial appendage wall, allowing the contracted anchoring layer to cling to the inner wall of the left atrial appendage, thereby ensuring an anchoring effect. During the deployment process, the connecting ribs pull the occlusion disc toward the side where the anchoring cup is located, so that the occlusion disc fits the left atrial appendage opening.

[0038] S03. When blood flows through the outer disc of the occluding disc, a pressure difference is formed on both sides of the disc surface of the outer disc, which applies pressure toward the inside of the left atrial appendage to the occluding disc, so that the occluding disc is pressed into place; when the left atrial appendage occluder is deformed by force, the deformation amplitude of the occluding disc is smaller than the deformation amplitude of the connecting ribs and the anchoring cup, and the main deformation is provided by the connecting ribs and the anchoring cup.

[0039] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A novel left atrial appendage occluder, characterized in that: The invention comprises an occluding disk (1) for occluding, an anchoring cup (2) for anchoring the position of a left atrial appendage occluder, and a connecting rib (3) for connecting the anchoring cup (2) and the occluding disk (1), wherein the anchoring cup (2) is a hemispherical double-layer structure, comprising an outer shrinkage anchoring layer (4) and an inner support layer (5), the distal end of the shrinkage anchoring layer (4) is bundled by a distal bundle tube (6), the proximal end of the support layer (5) is connected to the proximal end of the shrinkage anchoring layer (4), and the distal end is connected to the connecting rib (3), a space for the shrinkage anchoring layer (4) to be compressed and deformed is formed between the shrinkage anchoring layer (4) and the support layer (5), and a space is formed between the shrinkage anchoring layer (4) and the support layer (5) for the shrinkage anchoring layer (4) to be compressed and deformed. ) The braiding density of the proximal connection is greater than the braiding density of the contraction anchoring layer (4) and the support layer (5), and an anchor hook (7) with an end protruding from the surface of the contraction anchoring layer (4) is provided on the contraction anchoring layer (4); the occluding disc (1) adopts a double-layer ring disc structure, including an inner disc (8) connected to the connecting rib (3) and an outer disc (9) located at the proximal end, the curvature of the disc surface of the outer disc (9) close to the distal end is greater than the curvature of the disc surface close to the proximal end, when blood flows through the outer disc (9), a pressure difference is formed on both sides of the outer disc (9), pressing the occluding disc (1) against the ear opening of the left atrial appendage; the proximal end of the outer disc (9) is bundled by the proximal bundle tube (10).

2. A novel left atrial appendage occluder according to claim 1, characterized in that: The connecting rib (3) adopts a truncated cone structure, with one end with a smaller diameter connected to the distal end of the support layer (5), and the other end connected to the distal end of the occluding disc (1). When the anchor cup (2) is unfolded, the occluding disc (1) is pulled closer to the side where the anchor cup (2) is located through the connecting rib (3).

3. The novel left atrial appendage occluder according to claim 1, characterized in that: The anchor hooks (7) include two groups of hooks with a height difference, a connecting rod (11) is provided between the two groups of hooks for connection, the hooks and the connecting rod (11) are integrally formed and evenly distributed on the anchor cup (2), and the ends of the hooks face the side where the sealing disc (1) is located.

4. The novel left atrial appendage occluder according to claim 1, characterized in that: The occluding disc (1), the connecting rib (3) and the anchoring cup (2) are integrally woven, the weaving density of the occluding disc (1) being smaller than the weaving density of the anchoring cup (2) and the connecting rib (3); and the deformation capacity of the occluding disc (1) being smaller than the deformation capacity of the anchoring cup (2) and the deformation capacity of the connecting rib (3).

5. The novel left atrial appendage occluder according to claim 1, characterized in that: The expanded diameter of the occluding disc (1) is greater than the expanded diameter of the anchoring cup.

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