A plug-type left atrial appendage occluder

Abstract

The utility model discloses a plug type left auricle of heart stopper, including the plug body of net, one end of plug body is equipped with the first connecting piece for connecting positioning structure, the other end of plug body is equipped with the second connecting piece for connecting conveying instrument, be equipped with the stoppage film on plug body, the outer periphery of plug body is equipped with the anchoring structure. The plug type left auricle of heart stopper can cooperate with the positioning plug with the positioning plug as the support adjustment release position and angle, to obtain better stoppage effect, avoid turning over, improve the success rate of operation, simple operation, safe and reliable.

Description

Technical Field

[0001] This utility model relates to the field of left atrial appendage occlusion technology, specifically to a plug-type left atrial appendage occluder. Background Technology

[0002] Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, with an incidence rate of approximately 1%-2% in the general population. About 7% of people over 65 years of age have AF, while the incidence rate rises to 15%-20% in those over 80 years of age. The most common and serious complication of AF is ischemic stroke, accounting for approximately 20%-30% of all strokes. AF is 5.6 times more likely to cause ischemic stroke than non-AF patients, with a one-year mortality rate reaching 30%. The high disability and mortality rates associated with strokes caused by AF place a significant burden on individuals, families, and society. Therefore, preventing thromboembolic events in patients with AF is crucial.

[0003] Patients with atrial fibrillation (AF) are prone to thrombus formation within the atria, and the left atrial appendage (LAA) is the primary origin of thrombi in AF patients, accounting for over 90% of thrombi in non-valvular AF. Therefore, oral anticoagulants (OACs) are particularly necessary for AF patients to prevent thrombus detachment and subsequent stroke and peripheral thromboembolism. However, a significant number of patients are unwilling to undergo long-term, standardized OAC treatment due to the high risk of bleeding. Percutaneous left atrial appendage occlusion (PLAAC) has been proven to be an effective alternative treatment for reducing the risk of thromboembolism in AF patients who cannot tolerate OAC, significantly reducing cardiovascular mortality and all-cause mortality. PLAAC involves percutaneously inserting a left atrial appendage occluder into the left atrial appendage (LAA) via a small-diameter delivery sheath. The occluder seals the opening of the left atrial appendage, thereby preventing thromboembolism induced by atrial fibrillation. Currently, most left atrial appendage occluders are made of nickel-titanium alloy with a polymer coating. The nickel-titanium alloy mainly serves to fix the appendage, while the polymer coating mainly serves to block blood flow.

[0004] Currently, left atrial appendage occlusion devices are mainly divided into cap-type occluders and plug-type occluders. Cap-type occluders rely on the cap fitting snugly against the opening of the left atrial appendage to seal it. They require precise control of axial force and positioning after release; if the cap does not fit well against the opening, the procedure will fail. Plug-type occluders need to be inserted into the left atrial appendage. During the procedure, a sheath needs to be inserted into the left atrial appendage to release the occluder. The release angle is critical; if the occluder twists during release, the procedure may fail, requiring emergency open-heart surgery, causing additional pain and risks for the patient. Utility Model Content

[0005] This invention addresses the above-mentioned problems by researching and designing a plug-type left atrial appendage occlusion device. The technical means employed in this invention are as follows: A plug-type left atrial appendage occluder includes a mesh plug body, one end of which is provided with a first connector for connecting to a positioning structure, and the other end of which is provided with a second connector for connecting to a delivery device. An occlusion membrane is provided on the plug body, and an anchoring structure is provided on the outer periphery of the plug body.

[0006] Furthermore, the plug is a drum-shaped or cylindrical shape with smooth edges, and the plug has a woven mesh structure or a laser-engraved mesh structure. One end face of the plug is closed and fixed to the first connector, and the other end face of the plug is closed and fixed to the second connector.

[0007] Furthermore, the plug body is a plug-shaped structure made of interwoven threads, with one end of the threads gathered and fixed to the first connector, and the other end gathered and fixed to the second connector.

[0008] Furthermore, the two ends of the thread are respectively gathered outward and fixed to the first connector and the second connector.

[0009] Furthermore, the first connector is a detachable connector.

[0010] Furthermore, the first connector is a threaded connector or a mechanical plug connector, and the second connector is a threaded connector.

[0011] Furthermore, the anchoring structure is an anchor hook, which is curled toward one end of the first connector.

[0012] Furthermore, the outer periphery of the plug body is provided with two anchor hooks.

[0013] Furthermore, the outer end face of the plug body is provided with a concave structure, and the second connector is disposed at the concave structure.

[0014] Compared with existing technologies, the plug-type left atrial appendage occluder described in this utility model can be used in conjunction with a positioning plug. The release position and angle can be adjusted based on the positioning plug to achieve a better occlusion effect, avoid overturning, improve the success rate of surgery, and is simple to operate and safe and reliable. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the structure of the plug-type left atrial appendage occluder described in Embodiment 1 of this utility model.

[0016] Figure 2 yes Figure 1 Top view.

[0017] Figure 3 yes Figure 1 Enlarged view of point A.

[0018] Figure 4 yes Figure 1 Enlarged view of point B.

[0019] Figure 5 This is a schematic diagram of the structure of a segmented plug-type left atrial appendage occluder formed by connecting the positioning plug and the plug-type left atrial appendage occluder as described in Embodiment 1 of this utility model.

[0020] Figure 6 This is a schematic diagram of the positioning plug described in Embodiment 1 of this utility model.

[0021] Figure 7 yes Figure 6 Top view.

[0022] Figure 8 This is a schematic diagram showing the shape of the positioning plug and the plug-type left atrial appendage occluder during the self-delivery sheath release process in an embodiment of this utility model.

[0023] Figure 9 This is a schematic diagram of the shape of the positioning plug being partially pushed out of the sheath and the plug-type left atrial appendage occluder still inside the sheath during the self-delivery sheath release process of this utility model embodiment.

[0024] Figure 10 This is a schematic diagram of the shape of the positioning plug being pushed out of the sheath and the plug-type left atrial appendage occluder still inside the sheath during the self-delivery sheath release process of this utility model embodiment.

[0025] Figure 11 This is a schematic diagram showing the shape of the self-delivery sheath release process in this embodiment of the utility model when both the positioning plug and the plug-type left atrial appendage occluder are pushed out of the sheath to achieve release.

[0026] Figure 12 This is a schematic diagram of the anchoring state inside the left atrial appendage structure according to an embodiment of the present invention (the positioning plug has been released, but the plug-type left atrial appendage occluder has not been released).

[0027] Figure 13 This is a schematic diagram of the anchoring state inside the left atrial appendage structure according to an embodiment of the present invention (both the positioning plug and the plug-type left atrial appendage occluder have been released).

[0028] Figure 14 This is a schematic diagram comparing the deformed state and the natural state of Embodiment 1 of this utility model under the anchored state inside the left atrial appendage.

[0029] Figure 15 This is a schematic diagram of the structure of the plug-type left atrial appendage occluder described in Embodiment 2 of this utility model.

[0030] Figure 16This is a schematic diagram of the structure of a segmented plug-type left atrial appendage occluder formed by connecting the positioning plug and the plug-type left atrial appendage occluder as described in Embodiment 3 of this utility model.

[0031] Figure 17 This is a structural schematic diagram of the third connector described in Embodiment 3 of this utility model.

[0032] Figure 18 This is a schematic diagram of the structure of the first connector described in Embodiment 3 of this utility model.

[0033] Figure 19 This is a schematic diagram of the structure after the first connector and the third connector are mechanically inserted according to Embodiment 3 of this utility model.

[0034] Figure 20 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment 4 of this utility model.

[0035] Figure 21 This is a schematic diagram of the anchoring state inside the left atrial appendage structure in Embodiment 4 of this utility model (both the positioning plug and the plug-type left atrial appendage occluder have been released).

[0036] Figure 22 This is a schematic diagram of the anchoring state inside the early lobulated left atrial appendage structure in Embodiment 4 of this utility model (both the positioning plug and the plug-type left atrial appendage occluder have been released).

[0037] Figure 23 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment 5 of this utility model.

[0038] Figure 24 This is a schematic diagram of the anchoring state inside the left atrial appendage structure in Embodiment 5 of this utility model (both the positioning plug and the plug-type left atrial appendage occluder have been released).

[0039] Figure 25 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment Six of this utility model.

[0040] Figure 26 This is a schematic diagram of the anchoring state inside the left atrial appendage structure in Embodiment 6 of this utility model (both the positioning plug and the plug-type left atrial appendage occluder have been released).

[0041] Figure 27 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment 7 of this utility model.

[0042] Figure 28 This is a schematic diagram of the positioning plug described in Embodiment 7 of this utility model.

[0043] Figure 29 This is a schematic diagram of the structure of the plug-type left atrial appendage occluder described in Embodiment 7 of this utility model.

[0044] Figure 30 This is a schematic diagram of the anchoring state inside the left atrial appendage structure in Embodiment 7 of this utility model.

[0045] Figure 31 This is a schematic diagram of the anchoring state of a plug-type left atrial appendage occluder with relatively small thickness in the existing technology.

[0046] Figure 32 This is a schematic diagram of the anchoring force of a thick plug-type left atrial appendage occluder in the existing technology.

[0047] Figure 33 This is a schematic diagram of the forces acting on the segmented plug-type left atrial appendage occluder described in this embodiment of the invention in the anchored state.

[0048] Figure 34 This is a schematic diagram of the anchoring state of a cap-type occluder in the early lobulated left atrial appendage in the existing technology (complete occlusion is not achieved).

[0049] Figure 35 This is a schematic diagram of the anchoring state of a cap-type occluder in the left atrial appendage where coaxiality is poor (complete occlusion is not achieved).

[0050] Figure 36 This is a schematic diagram of the left atrial appendage occluder described in this embodiment of the invention being anchored under the pulling action of the positioning plug.

[0051] Figure 37 This is a schematic diagram of the left atrial appendage occluder described in this embodiment of the invention being anchored under the support of the positioning plug.

[0052] Figures 38 to 40 These are anatomical images of three animals one month after implantation in an animal experiment according to an embodiment of this utility model.

[0053] Figure 41 and Figure 42 This is an anatomical diagram of an animal experiment three months after implantation in an embodiment of this utility model. Detailed Implementation

[0054] Example 1 like Figures 1 to 7As shown, a plug-type left atrial appendage occluder 2 includes a mesh plug body. One end of the plug body is provided with a first connector 21 for connecting to a positioning structure, and the other end of the plug body is provided with a second connector 22 for connecting to a delivery device. An occlusion membrane 3 is provided on the plug body, and an anchoring structure 6 is provided on the outer periphery of the plug body. The material of the occlusion membrane 3 may be, but is not limited to, polyethylene terephthalate (PET). The positioning structure described in this embodiment is a positioning plug 1. The plug-type left atrial appendage occluder 2 is used in conjunction with the positioning plug 1. The positioning plug 1 is released first in the left atrial appendage. After release, it plays a role in positioning, sealing, and supporting the plug-type left atrial appendage occluder 2. During the release of the plug-type left atrial appendage occluder 2, the position of the plug-type left atrial appendage occluder 2 can be adjusted based on the positioning plug 1 to obtain a better sealing effect. At the same time, under the sealing and support of the positioning plug 1, no damage will be caused to the inner wall of the left atrial appendage. Existing occluders often fail to maintain coaxiality in many situations, leading to overturning and necessitating open-chest surgery. This invention addresses this issue by using a positioning plug 1 and a plug-type left atrial appendage occluder 2 in conjunction. The positioning plug 1 is first released for fixation, then used as a support and limiting structure to adjust the release position and angle of the plug-type left atrial appendage occluder 2. Furthermore, it allows for release of the occluder 2 under axial thrust or tension, ensuring accurate release and complete occlusion. Under the limiting and support of the positioning plug 1, the left atrial appendage occluder 2 achieves occlusion through radial interaction with the inner wall of the left atrial appendage, minimizing coaxiality requirements and eliminating the risk of overturning. Additionally, the positioning plug 1 and the plug-type left atrial appendage occluder 2 can be configured with different sizes to adapt to the internal shape of the left atrial appendage, achieving better occlusion results. In this embodiment, the plug is inserted into the left atrial appendage for fixation. It relies on the radial expansion force of the plug body to achieve sealing, resulting in more complete sealing. After sealing, the sealing surface is flat and has a smaller area, which is more conducive to endometrialization.

[0055] The positioning plug 1 described in this embodiment is a plug-like structure made of interwoven threads. One end of the threads is gathered and fixed to the fixing member 12, and the other end is gathered and fixed to the third connecting member 11. The plug body is disc-shaped. Since the fixing member 12 is inside the plug body and the third connecting member 11 is outside the plug body, the threads form a smooth curved surface between the third connecting member 11 and the fixing member 12. This allows the positioning plug 1 to maintain a smooth shape similar to a hot air balloon, gradually increasing in size, without any protrusions. The release position can be adjusted at any time during the release process without any protrusions causing damage to the inner wall of the left atrial appendage. In addition, the gathering and fixing of one end of the threads to the fixing member 12 and the other end to the third connecting member 11 ensures that both ends of each thread are fixed, and the relative positions between the threads are stable. After being gathered and released, the original weaving uniformity and density can still be maintained, avoiding fraying. At the same time, the two ends of the threads are fixed separately, but there is no direct constraint between them, allowing relative movement and providing a certain degree of flexibility for the deformation of the positioning plug 1.

[0056] As a preferred embodiment, the plug is a drum-shaped or cylindrical shape with smooth edges. In this embodiment, the drum shape has two circles as its base and a curved surface with a generatrix as a circular or elliptical arc as its side surface. The plug has a woven mesh structure. One end of the plug is gathered and fixed to the first connector 21, and the other end of the plug is gathered and fixed to the second connector 22. Specifically, a gathering, bundling, and welding fixing method can be used. More specifically, the plug is a plug-shaped structure made of interwoven threads. One end of each thread is gathered outwards and fixed to the first connector 21, and the other end is gathered outwards and fixed to the second connector 22. One end of the thread is gathered and fixed to the first connector 21, and the other end is gathered and fixed to the second connector 22, so that both ends of each thread are fixed and the relative positions between the threads are stable. After being gathered and unwound, the original weaving uniformity and density can still be maintained, avoiding fraying. At the same time, the two ends of the thread are fixed separately, but there is no direct constraint between the two ends, allowing relative movement. This facilitates adjustment of the left atrial appendage occluder 2 during release, achieving more precise release. The first connector is a connection structure for connecting the plug-type left atrial appendage occluder 2 and the positioning plug 1 before use. In this embodiment, the first connector 21 and the third connector 11 can be set as a one-time snap-fit ​​mechanical connection or a detachable connection. The corresponding positioning plug 1 and plug-type left atrial appendage occluder 2 can be selected and combined before surgery according to needs, or they can be disassembled and reassembled. Both the first connector 21 and the third connector 11 are threaded connectors. The connection structure, especially the threaded connection structure, allows for free connection before use. The dimensions of the positioning plug 1 and the plug-type left atrial appendage occluder 2 can be adjusted and selected according to different left atrial appendage morphologies. They can be assembled before surgery. For example, if a certain brand of occluder has 8 models in the 16-30 mm size range, and in this embodiment, with 8 models each of the positioning plug and the plug-type left atrial appendage occluder 2, 64 models of left atrial appendage occluders can be assembled, as shown in the table below. This is suitable for left atrial appendages of various shapes and sizes, and can also be used to occlude early lobulated atrial appendages. It is safe, controllable, and ensures the success rate of the surgery and the occlusion effect.

[0057]

[0058] As a preferred embodiment, the anchoring structure is an anchor hook, which is curled towards one end of the first connector. Alternatively, a portion of the wire in the plug-type left atrial appendage occluder 2 has a flat portion 61, and the anchor hook 6 is a hook-shaped structure formed by laser engraving and curling from the flat portion. The flat portion 61 can be formed by forging the wire portion, resulting in a stable anchor hook 6 that maintains its preset orientation even after folding and release. Furthermore, when folded and retracted into the delivery sheath, the anchor hook can straighten and return to the laser-engraved hollow portion without occupying additional space. The combined action of the anchor hook 6 and the plug body effectively improves the anchoring strength of the occluder, thereby reducing the risk of dislodgement. As a preferred embodiment, the outer circumference of the plug body has two sets of anchor hooks to further enhance the anchoring strength.

[0059] The usage process of this utility model embodiment is as follows: Select the appropriate positioning plug 1 and plug-type left atrial appendage occluder 2 according to the requirements. Connect the positioning plug 1 and plug-type left atrial appendage occluder 2 through the third connector 11 and the first connector 21. Connect the delivery steel cable 7, with threaded connectors welded to its end, to the second connector 22. Place the segmented plug-type left atrial appendage occluder consisting of the positioning plug 1 and the plug-type left atrial appendage occluder 2 into the delivery sheath 4. Figure 8 As shown, the occluder deforms under the constraint of the delivery sheath 4, then the head of the delivery sheath 4 is pushed into the left atrial appendage, and subsequently the delivery cable 7 is pushed. Figure 9 This is a schematic diagram showing the positioning plug 1 being pushed out of the delivery sheath during the release process, forming a smooth, protrusion-free structure. The anchor hook retracts inward near the center to avoid damage to the distal left atrial appendage. At this time, the position of the positioning plug can be adjusted to ensure more accurate release. Figure 10 This is a schematic diagram showing the positioning plug 1 fully extended from the delivery sheath 4 and deployed. The smooth structure of the positioning plug 1 avoids damage to the left atrial appendage; as shown... Figure 11As shown, the delivery cable 7 continues to be pushed, and the plug-type left atrial appendage occluder 2 is pushed out of the delivery sheath 4. Since the positioning plug 1 has completed its release and fixation first, the release position and angle of the plug-type left atrial appendage occluder 2 can be adjusted during the pushing process, relying on the positioning plug 1. By controlling the delivery cable 7, the occluder can be compressed, stretched, or radially adjusted to better seal the opening of the left atrial appendage. At the same time, since the front end of the positioning plug 1 has no protrusion, there is no safety hazard of puncturing the inner wall of the left atrial appendage when axially compressing and adjusting the plug-type left atrial appendage occluder 2, which further ensures the flexibility of the occluder adjustment, and the operation process is easy to control, safe and reliable. The positioning plug 1 adapts to the obstruction of the left atrial appendage by deforming itself to fit the internal structure of the left atrial appendage, thus locking itself inside. The plug-type left atrial appendage occluder 2 is locked at the opening of the left atrial appendage. The anchor hooks 6 on the outer periphery of the positioning plug 1 and the plug-type left atrial appendage occluder 2 are anchored to the inner wall of the left atrial appendage. The positioning plug 1 and the plug-type left atrial appendage occluder 2, together with the flow-blocking membrane 3 (the material of the flow-blocking membrane can be polyethylene terephthalate (PET)), achieve the occlusion of the left atrial appendage, thereby preventing thromboembolism. Finally, the delivery cable 7 is rotated in the opposite direction to separate it from the second connector 22. The delivery cable 7 and the delivery sheath 4 are then removed, completing the delivery and placement of the occluder. Figure 12 and Figure 13 This is a schematic diagram showing the anchoring state of the occluder described in this embodiment inside the left atrial appendage 8 structure. Figure 12 This is a schematic diagram showing the positioning plug after it has been released from the left atrial appendage (Atrial 8). Figure 13 This is a schematic diagram showing the positioning plug 1 and the plug-type left atrial appendage occluder 2 after being released into the left atrial appendage 8. Because the plug-type left atrial appendage occluder 2 described in this embodiment has a plug-type structure and is fixed inside the left atrial appendage, the sealing surface is flat and has a small area after occlusion, which is more conducive to endometrialization.

[0060] The braided structure of the plug-type left atrial appendage occluder 2 allows it to widen under the compression of the left atrial appendage wall after release, i.e., increasing in thickness. This reduces the radial dimensions corresponding to both bottom surfaces, resulting in flexible deformation and easier attainment of a steady state. The increased deformation due to compression ensures moderate interaction force between the plug-type left atrial appendage occluder 2 and the left atrial appendage wall, facilitating force balance. It also ensures a tight fit against the left atrial appendage wall, preventing excessive pressure. Furthermore, the increased anchoring thickness ensures more complete occlusion. Figure 14 As shown.

[0061] The release principle of this embodiment includes: (1) positioning plug positioning; (2) positioning plug sealing limit, which can play a traction role and also a sealing limit role; (3) the plug-type left atrial appendage occluder 2 becomes wider after sealing and release; (4) after the plug-type left atrial appendage occluder 2 is fixed, the occluder can be pulled to perform stability test; (5) release the occluder connection to complete the sealing.

[0062] Example 2 like Figure 15 As shown, the difference between this embodiment and Embodiment 1 is that a concave structure 23 is provided on the outer end face of the plug in this embodiment, and the second connector is disposed at the concave structure 23, which is beneficial for postoperative endometrialization. In this embodiment, concave structures 23 can be provided on both end faces of the plug. Other structures, usage methods, and beneficial effects of this embodiment are the same as those of Embodiment 1, and will not be repeated here.

[0063] Example 3 like Figures 16 to 19 As shown, the difference between this embodiment and Embodiment 1 is that the first connector 21 in this embodiment is a mechanical insertion connector, which cooperates with the third connector 11 of the positioning plug 1 for mechanical insertion.

[0064] As a preferred embodiment, the third connector 11 includes a snap-fit ​​member 111 and an elastic connection structure 112. The first connector 21 has a slot 211. The snap-fit ​​member 111 can enter the slot 211 under the elastic force of the elastic connection structure 112 to realize the connection between the positioning plug 1 and the plug-type left atrial appendage occluder 2. The snap-fit ​​member 111 can be driven away from the slot 211 by external force, so that the positioning plug 1 is separated from the plug-type left atrial appendage occluder 2.

[0065] Specifically, the third connector 11 further includes a first snap-fit ​​portion 113 with a cylindrical structure. The first snap-fit ​​portion 113 has a first mounting groove 114 with an opening radially outward. The snap-fit ​​member 111 is installed in the first mounting groove 114 through an elastic connection structure 112. The elastic connection structure 112 can drive the snap-fit ​​member 111 to slide radially outward along the groove wall of the first mounting groove 114, and allow the end of the snap-fit ​​member 111 away from the elastic connection structure 112 to enter the snap-fit ​​groove 211. In this embodiment, the end face of the snap-fit ​​member 111 away from the elastic connection structure 112 is a smooth cylindrical surface, which facilitates the quick installation of the snap-fit ​​member 111 into the first connector 21 during the connection process between the third connector 11 and the first connector 21. This improves the connection efficiency between the third connector 11 and the first connector 21, thereby improving the connection and assembly efficiency between the positioning plug 1 and the plug-type left atrial appendage occluder 2.

[0066] In a specific embodiment, the slot 211 is a groove structure arranged in the radial direction of the first connector 21, and the slot 211 is connected to the outside. The first connector 21 is a column structure. The slot 211 structure, which is connected to the outside, facilitates the disassembly and separation of the positioning plug 1 and the plug-type left atrial appendage occluder 2. When external force is applied to the outside of the slot 211, the snap-fit ​​member 111 on the positioning plug 1 is driven to move towards the first mounting groove 114. The snap-fit ​​member is squeezed inward through the slot, and the snap-fit ​​member 111 is pushed out of the slot 211. At this time, the elastic connection structure 112 is compressed. Then, the positioning plug 1 is driven to move away from the plug-type left atrial appendage occluder 2 by external force, so that the positioning plug 1 and the plug-type left atrial appendage occluder 2 can be separated. After the positioning plug 1 and the plug-type left atrial appendage occluder 2 are separated, the elastic connection structure 112 drives the snap-fit ​​member 111 to reset.

[0067] When assembling the positioning plug 1 with the plug-type left atrial appendage occluder 2, an external force is used to press the locking member 111 radially inward, compressing the elastic connection structure 112. Then, the third connecting member 11 on the positioning plug 1 is inserted axially into the first connecting member 21 on the plug-type left atrial appendage occluder 2. During this process, the locking member 111 moves along the inner wall of the first connecting member 21. When the locking member 111 moves to the position corresponding to the slot 211, most of the component structure of the locking member 111 near the slot 211 will enter the slot 211, while the small portion of the component structure of the locking member 111 away from the slot 211 remains in the first mounting groove 114. The snap-fit ​​component 111 engages with the inner wall of the first mounting groove 114 and the inner wall of the slot 211 to achieve the snap-fit ​​between the third connector 11 and the first connector 21, thereby connecting the positioning plug 1 and the plug-type left atrial appendage occluder 2. The snap-fit ​​structure formed by the third connector 11 and the first connector 21 can greatly improve the ease of connection and assembly of the positioning plug 1 and the plug-type left atrial appendage occluder 2, and improve the ease of disassembly of the two. At the same time, the snap-fit ​​structure formed by the third connector 11 and the first connector 21 can also ensure the reliability of the connection between the positioning plug 1 and the plug-type left atrial appendage occluder 2, and prevent the two from separating unexpectedly during use.

[0068] In a specific embodiment, at least two snap-fit ​​members 111 are symmetrically provided on the first snap-fit ​​portion 113. The number of snap-fit ​​slots 211 is the same as the number of snap-fit ​​members 111, that is, at least one pair of snap-fit ​​members 111 and elastic connecting structures 112 are symmetrically provided on the first snap-fit ​​portion 113 to cooperate with the snap-fit ​​slots 211, thereby ensuring the stability and reliability of the connection between the third connector 11 and the first connector 21. In this embodiment, two snap-fit ​​members 111, two elastic connecting structures 112 and two snap-fit ​​slot structures 211 are symmetrically provided.

[0069] The other structures, usage methods, and beneficial effects of this embodiment are the same as those of Embodiment 1, and will not be repeated here.

[0070] Example 4 like Figure 20 and Figure 21 As shown, the difference between this embodiment and Embodiment 1 is that the positioning plug 1 and the plug-type left atrial appendage occluder 2 in Embodiment 1 have the same diameter, while the diameter of the positioning plug 1 in this embodiment is smaller than the diameter of the plug-type left atrial appendage occluder 2. This embodiment is suitable for left atrial appendages 8 with an internal space diameter smaller than the orifice diameter, or for early-lobulated left atrial appendages, such as... Figure 22 As shown, for early-lobed left atrial appendages 8, the internal space and mouth are usually not well coaxial. Due to the fixing and limiting effect of the positioning plug 1 on the plug-type left atrial appendage occluder 2, a certain angle is allowed between the positioning plug 1 and the plug-type left atrial appendage occluder 2 for fixing. In this case, the plug-type left atrial appendage occluder 2 is fixed under the pulling action of the positioning plug 1, or one side of the plug-type left atrial appendage occluder 2 is limited by the positioning plug 1, and the other side is pulled by the positioning plug 1. The applicable principle for other ventricles with poor coaxiality is the same. The other structures, usage methods and beneficial effects of this embodiment are the same as those of Embodiment 1, and will not be repeated here.

[0071] Example 5 like Figure 23 and Figure 24 As shown, the difference between this embodiment and Embodiment 1 is that the diameter of the positioning plug 1 in this embodiment is larger than the diameter of the plug-type left atrial appendage occluder 2. This embodiment is suitable for left atrial appendages 8 where the diameter of the internal space of the endocardium is larger than the diameter of the opening. Such left atrial appendages are difficult to fix using existing plug-type occluders, and even if fixation is successful, the risk of postoperative dislodgement is high. This embodiment solves this problem by using the larger-diameter positioning plug 1 to release and fix the device first. Under the limiting and fixing effect of the positioning plug 1, the plug-type left atrial appendage occluder 2 is released and fixed. Because the positioning plug 1 can limit and fix the plug-type left atrial appendage occluder 2, the plug-type left atrial appendage occluder 2 will not dislodge due to its smaller opening diameter. Other structures, usage methods, and beneficial effects of this embodiment are the same as in Embodiment 1, and will not be repeated here.

[0072] Example 6 like Figure 25 and Figure 26 As shown, the difference between this embodiment and Embodiment 1 is that in Embodiment 1, the positioning plug 1 is disc-shaped and the plug-type left atrial appendage occluder 2 is drum-shaped, while in this embodiment, both the positioning plug 1 and the plug-type left atrial appendage occluder 2 are drum-shaped. Other structures and beneficial effects of this embodiment are the same as in Embodiment 1, and will not be repeated here.

[0073] Example 7 like Figures 27 to 30As shown, the difference between this embodiment and Embodiment 1 is that the positioning plug 1 and the plug-type left atrial appendage occluder 2 in this embodiment are laser-engraved mesh structures. For the positioning plug 1, one end of the laser-engraved wire is gathered inward and welded to the fixing member 12, and the other end is gathered outward and welded to the third connecting member 11. For the plug-type left atrial appendage occluder 2, one end of the laser-engraved wire is gathered outward and fixed to the first connecting member 21, and the other end is gathered outward and fixed to the second connecting member 22. Other structures, usage methods and beneficial effects of this embodiment are the same as those of Embodiment 1, and will not be repeated here.

[0074] The left atrial appendage (LAA) exhibits numerous morphologies and shapes, as described in the literature "The Left Atrial Appendage: Anatomy, Function, and Noninvasive Evaluation" (JACC: CARDIOVASCULAR IMAGING, Vol. 7, No. 12, 2014). These include, but are not limited to, cauliflower-shaped, wind-stocking-shaped, cactus-shaped, and chicken-wing-shaped LAAs. Furthermore, the specific dimensions and shapes of each LAA morphology vary, and the internal spaces also differ significantly. Some LAAs have an internal diameter larger than the opening diameter, some have an internal diameter similar to the opening diameter, and some have an internal diameter smaller than the opening diameter. Some LAAs exhibit early lobulation, and some display anisoaxiality, among others. Existing LAA occluders cannot meet the diverse occlusion requirements of different LAA sizes, and almost none can achieve 100% occlusion. Existing plug-type occluders pose a risk of overturning or extrusion in many scenarios, especially in cases of poor ventricular coaxiality or early-lobulated left atrial appendages. If the plug is thin or the anchoring thickness is insufficient, the occluder receives only a radially inward force f from the inner wall of the left atrial appendage, resulting in almost uniform force distribution and unstable stress state. This makes the occluder prone to overturning. Figure 31 As shown; if a thicker occluder is used, due to the limited internal space, the inner side is subjected to a larger compressive force f', resulting in greater deformation, while the outer side receives a smaller compressive force, generating an axial outward component force. This causes the occluder to be subjected to an outward thrust, creating a risk of it being extruded, such as... Figure 32 As shown; once rollover or extrusion occurs, immediate open-chest surgery is necessary, posing significant risks and pain to the patient. Figure 33As shown, in this embodiment of the present invention, the positioning plug 1 first achieves fixation, generating a multi-directional supporting force f'' or accompanied by traction and thrust on the plug-type left atrial appendage occluder in the radial direction. At the same time, the inner wall of the left atrial appendage applies a radially inward pressure f'' to the outer plug structure. The plug-type left atrial appendage occluder in this embodiment is subjected to forces from multiple points, and the force points are not on the same plane, exhibiting a three-dimensional force state. The force is stable, with no risk of overturning or falling off. After being compressed and deformed, the positioning plug 1 is anchored inside the left atrial appendage. Since it allows for a certain degree of deformation, and the fixing member and the first connecting member are mutually free, the plug-type left atrial appendage occluder is allowed to be anchored at a certain angle to the inner plug structure. It can also apply a pushing and pulling force to the occluder during the release process to achieve precise fixation. Existing cap-type occluders rely on the axial tension provided by the inner plug for sealing, requiring high coaxiality. Given the diverse shapes of the left atrial appendage, complete sealing is often impossible. In cases of poor ventricular coaxiality or early-lobulated left atrial appendages, the inner plug and the cap-type outer plug cannot be coaxially aligned, leading to asymmetrical sealing and leaks, thus failing to achieve the desired sealing effect. Figure 34 and Figure 35 As shown.

[0075] In all embodiments of this utility model, the positioning plug is used to limit and fix the entire plug body. Fixing means that after the positioning plug is released and fixed, the release position of the plug-type left atrial appendage occluder 2 is fixed. The plug-type left atrial appendage occluder 2 is either pulled to fix it at the orifice of the left atrial appendage ventricle, or supported to fix it at the orifice of the left atrial appendage ventricle. Figure 36 and Figure 37 As shown; once the positioning plug is fixed, since it is fixed inside the left atrial appendage, when releasing the plug-type left atrial appendage occluder 2, the plug-type left atrial appendage occluder 2 can be appropriately pushed and pulled to release the outer plug structure in the most appropriate position (the atrial appendage is elastic and irregular in shape, and the stress conditions in different places are also different. At the same time, the left atrial appendage also changes with the heartbeat during the operation. The application of previous occluders was limited due to the complexity of the atrial appendage), without any risk caused by the pushing and pulling action, and without the difficulty in controlling the position of the occluder due to the positioning and withdrawal of the tube required for the release of the existing internal plug-type occluder.

[0076] The product of this utility model embodiment has undergone multiple animal experiments, with implantation surgery performed on 18 dogs. Given the generally high perforation intervals in current surgeries and the near impossibility of achieving complete occlusion with existing products, the occlusion rate of this utility model embodiment reaches 100%, with no residual shunting. Furthermore, the operation process is easy to control and safe and reliable. One month post-operative esophageal ultrasound examination showed no thrombus, residual shunting, occluder dislodgement or displacement, or cardiac tamponade on the occluder surface. Figures 38 to 40As shown. In this embodiment of the invention, an animal was dissected three months after implantation of the occluder. The dissected heart structure was unaffected and undamaged, and all organs and tissues were undamaged. Dissection of the left atrial appendage revealed no thrombus on the surface of the occluder, and complete endothelialization. Figure 41 and Figure 42 As shown, this invention demonstrates high safety and good tissue biocompatibility. In animal experiments, the left atrial appendage occluder was implanted in 12 dogs in one day (9:00-18:00), indicating that the occluder is easy to operate, with no cardiac tamponade during implantation, and is highly efficient, safe, and possesses the beneficial effects of structural adaptability, operational safety, and long-term effectiveness.

[0077] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A plug-type left atrial appendage occlusion device, characterized in that: The device includes a mesh plug, one end of which is provided with a first connector for connecting to a positioning structure, and the other end of which is provided with a second connector for connecting to a delivery device. The plug is provided with a sealing membrane, and the outer periphery of the plug is provided with an anchoring structure.

2. The plug-type left atrial appendage occlusion device according to claim 1, characterized in that: The plug is a drum-shaped or cylindrical shape with smooth edges. The plug has a woven mesh structure or a laser-engraved mesh structure. One end face of the plug is closed and fixed to the first connector, and the other end face of the plug is closed and fixed to the second connector.

3. The plug-type left atrial appendage occlusion device according to claim 2, characterized in that: The plug is a plug-shaped structure made of interwoven threads, with one end of the threads gathered and fixed to the first connector and the other end gathered and fixed to the second connector.

4. The plug-type left atrial appendage occlusion device according to claim 3, characterized in that: The two ends of the thread are respectively gathered outward and fixed to the first connector and the second connector.

5. The plug-type left atrial appendage occlusion device according to any one of claims 1 to 4, characterized in that: The first connector is a threaded connector or a mechanical plug connector, and the second connector is a threaded connector.

6. The plug-type left atrial appendage occlusion device according to any one of claims 1 to 4, characterized in that: The first connector is a detachable connector.

7. The plug-type left atrial appendage occlusion device according to claim 1, characterized in that: The anchoring structure is an anchor hook, which is curled toward one end of the first connector.

8. The plug-type left atrial appendage occlusion device according to claim 7, characterized in that: The plug body has two anchor hooks on its outer periphery.

9. The plug-type left atrial appendage occlusion device according to claim 1, characterized in that: The outer end face of the plug is provided with a concave structure, and the second connector is disposed at the concave structure.

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