Positioning plug for segmented plug left atrial appendage occluder

Abstract

The utility model discloses a kind of positioning plugs for segmented plug type left atrial appendage occluder, including the plug body of net, the one end of plug body is equipped with the connecting piece for connecting occlusion plug, the outer periphery of plug body is equipped with anchoring structure, in release process, in addition to anchoring structure, the contact form that plug body can form with left atrial appendage is all smooth surface contact.Forming positioning plug with segmented plug type left atrial appendage occluder and occlusion plug cooperation use, can support and position occlusion plug, can be as the support of occlusion plug in the process of occlusion plug release, position and release angle adjustment are carried out to occlusion plug, to obtain better occlusion effect, avoid turning over, avoid damaging left atrial appendage inner wall simultaneously, 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 positioning plug for a segmented 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 therapy 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 therapy, 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 and releasing it. 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 designing a positioning plug for a segmented plug-type left atrial appendage occlusion device. The technical means employed in this invention are as follows:

[0006] A positioning plug for a segmented plug-type left atrial appendage occluder includes a mesh plug body, one end of which is provided with a connector for connecting to the occluder, and the outer periphery of the plug body is provided with an anchoring structure. During release, except for the anchoring structure, the contact form that the plug body may form with the left atrial appendage is a smooth surface contact.

[0007] Furthermore, the plug is disc-shaped, drum-shaped with smooth edges, or cylindrical with smooth edges. The plug has a woven mesh structure. One end of the plug is drawn outward and fixed to the connector, while the other end of the plug is drawn inward and fixed to the fixing member. The part of the plug facing away from the anchoring structure is a structure without any protrusions on its surface.

[0008] Furthermore, the plug body is a plug-shaped structure made of intersecting and woven threads that are inclined in two directions. One end of the threads is gathered and tied to the fixing member, and the other end is gathered and tied to the connecting member.

[0009] Furthermore, one end of the thread gradually converges and is tied to the connector, forming a trumpet-shaped transition section between the connector and the plug.

[0010] Furthermore, the plug is disc-shaped, and the filaments form a smooth curved surface between the connector and the fixing member.

[0011] Furthermore, the connector is a threaded connector or a mechanically inserted connector.

[0012] Furthermore, the connector is a detachable connector.

[0013] Furthermore, the anchoring structure is an anchor hook, which is curled toward one end of the connector.

[0014] Furthermore, the plug body is provided with a flow-blocking membrane, which covers the inner wall of the plug body.

[0015] Compared with existing technologies, the segmented plug-type left atrial appendage occluder of this invention uses a positioning plug in conjunction with the occluder plug to support and position the occluder plug. It can also serve as a support for the occluder plug during release, allowing for adjustment of the occluder plug's position and release angle to achieve better occlusion, prevent overturning, avoid damage to the inner wall of the left atrial appendage, improve the success rate of the surgery, and is simple to operate and safe and reliable. Attached Figure Description

[0016] Figure 1This is a schematic diagram of the positioning plug described in Embodiment 1 of this utility model.

[0017] Figure 2 yes Figure 1 Top view.

[0018] Figure 3 yes Figure 1 Enlarged view of point A.

[0019] Figure 4 yes Figure 1 Enlarged view of point B.

[0020] Figure 5 This is a schematic diagram of the structure of the segmented plug-type left atrial appendage occluder formed by connecting the positioning plug and the sealing plug according to Embodiment 1 of this utility model.

[0021] Figure 6 This is a schematic diagram of the sealing blockage structure described in Embodiment 1 of this utility model.

[0022] Figure 7 yes Figure 6 Top view.

[0023] Figure 8 This is a schematic diagram showing the shape of the positioning plug and sealing plug inside the sheath during the self-conveying sheath release process according to an embodiment of the present invention.

[0024] Figure 9 This is a schematic diagram showing the shape of the positioning plug being partially pushed out of the sheath and the sealing plug still inside the sheath during the self-conveying sheath release process of this utility model embodiment.

[0025] Figure 10 This is a schematic diagram of the shape of the positioning plug being pushed out of the sheath and the sealing plug still inside the sheath during the self-conveying sheath release process of this utility model embodiment.

[0026] Figure 11 This is a schematic diagram of the shape of the sheath when both the positioning plug and the sealing plug are pushed out of the sheath to achieve release in the self-conveying sheath process of this utility model embodiment.

[0027] 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 sealing plug has not been released).

[0028] 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 sealing plug have been released).

[0029] 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.

[0030] Figure 15This is a schematic diagram of the structure of the segmented plug-type left atrial appendage occluder formed by connecting the positioning plug and the sealing plug according to Embodiment 2 of this utility model.

[0031] Figure 16 This is a schematic diagram of the connector described in Embodiment 2 of this utility model.

[0032] Figure 17 This is a schematic diagram of the structure of the second connector described in Embodiment 2 of this utility model.

[0033] Figure 18 This is a schematic diagram of the structure of the connector and the second connector after mechanical insertion according to Embodiment 2 of this utility model.

[0034] Figure 19 This is a schematic diagram of the structure of the segmented plug-type left atrial appendage occluder formed by connecting the positioning plug and the sealing plug according to Embodiment 3 of this utility model.

[0035] Figure 20 This is a schematic diagram of the anchoring state of the segmented plug-type left atrial appendage occluder described in Embodiment 3 of this utility model inside the left atrial appendage structure (both the positioning plug and the occlusion plug have been released).

[0036] Figure 21 This is a schematic diagram of the anchoring state of the segmented plug-type left atrial appendage occluder described in Embodiment 3 of this utility model inside the early lobulated left atrial appendage structure (both the positioning plug and the occlusion plug have been released).

[0037] Figure 22 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment 4 of this utility model.

[0038] Figure 23 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 sealing plug have been released).

[0039] Figure 24 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment 5 of this utility model.

[0040] Figure 25 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 sealing plug have been released).

[0041] Figure 26 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment Six of this utility model.

[0042] Figure 27 This is a schematic diagram of the anchoring state inside the left atrial appendage structure in Embodiment Six of this utility model (both the positioning plug and the sealing plug have been released).

[0043] Figure 28This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment 7 of this utility model.

[0044] Figure 29 This is a schematic diagram of the positioning plug described in Embodiment 7 of this utility model.

[0045] Figure 30 This is a schematic diagram of the sealing blockage structure described in Embodiment 7 of this utility model.

[0046] Figure 31 This is a schematic diagram of the anchoring state inside the left atrial appendage structure in Embodiment 7 of this utility model.

[0047] Figure 32 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.

[0048] Figure 33 This is a schematic diagram of the anchoring force of a thick plug-type left atrial appendage occluder in the existing technology.

[0049] Figure 34 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.

[0050] Figure 35 This is a schematic diagram of the anchoring state of a cap-type occluder in an early-lobed left atrial appendage in the existing technology (complete occlusion is not achieved).

[0051] Figure 36 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).

[0052] Figure 37 This is a schematic diagram of the sealing plug being anchored under the pulling action of the positioning plug according to an embodiment of the present invention.

[0053] Figure 38 This is a schematic diagram of the sealing plug being anchored under the support of the positioning plug according to an embodiment of the present invention.

[0054] Figures 39 to 41 These are anatomical images of three animals one month after implantation in an animal experiment according to an embodiment of this utility model.

[0055] Figure 42 and Figure 43 This is an anatomical diagram of an animal experiment three months after implantation in an embodiment of this utility model. Detailed Implementation

[0056] Example 1

[0057] like Figures 1 to 7As shown, a positioning plug 1 for a segmented plug-type left atrial appendage occlusion device includes a mesh plug body. One end of the plug body is provided with a connector 11 for connecting to an occlusion structure. In this embodiment, the occlusion structure is an occlusion plug 2. An anchoring structure 6 is provided on the outer periphery of the plug body. The plug body 1 has a smooth surface without protrusions from the anchoring structure 6 to the end away from the connector. In this embodiment, the positioning plug 1 is used in conjunction with the occlusion plug 2. It is first released into the left atrial appendage. After release, it positions and supports the occlusion plug 2. During the release of the occlusion plug 2, the position of the occlusion plug 2 can be adjusted based on the positioning plug 1 to achieve a better occlusion effect. At the same time, the occlusion and support provided by the positioning plug 1 will not damage 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 an occluder plug 2 in tandem. Positioning plug 1 is first released for fixation, then used as a support and occlusion limiting structure to adjust the release position and angle of occluder plug 2. Furthermore, it allows for release of occluder plug 2 under axial thrust or tension, ensuring accurate release and complete occlusion. Under the limiting and support of positioning plug 1, occluder plug 2 achieves occlusion through radial interaction with the inner wall of the left atrial appendage. This design has low coaxiality requirements and eliminates the risk of overturning. Additionally, positioning plug 1 and occluder plug 2 can be configured with different sizes to adapt to the internal shape of the left atrial appendage, achieving better occlusion results. The plug body has a smooth, non-protruding surface from the anchoring structure 6 to the end furthest from the connector. This ensures that the portion of the positioning plug 1 that contacts the inner wall of the left atrial appendage during the entire release process is free of protrusions. This allows for adjustment of the release position at any time during release (e.g., in a semi-release state) without any protruding parts causing damage to the inner wall of the left atrial appendage. Preferably, the mesh plug body has a closed mesh structure. A closed mesh refers to a cage-like structure without specific openings. The mesh structure forms a closed curved surface, ensuring the stability of the plug body structure.

[0058] As a preferred embodiment, the plug is disc-shaped, drum-shaped with smooth edges, or cylindrical with smooth edges. In this embodiment, the disc-shaped plug has two circular bases as its top and bottom surfaces, and a curved surface with a generatrix forming an arc or elliptical arc as its side surface, with the side surface tangent to the base. The drum-shaped plug has two circular bases as its bases, and a curved surface with a generatrix forming an arc or elliptical arc as its side surface, with the base and side surfaces not tangent. The plug has a woven mesh structure. One end of the plug is drawn outwards and fixed to the connector 11, while the other end is drawn inwards and fixed to the fixing member 12. Preferably, the plug body is a plug-shaped structure made of symmetrically inclined crisscrossing 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 connecting member 11. Specifically, the fixing method can be gathered, tied and welded. One end of the threads is gradually gathered and tied to the connecting member, forming a trumpet-shaped transition section 13 between the connecting member and the plug body. The trumpet-shaped transition section 13 can increase the distance between the positioning plug 1 and the sealing plug 2, leaving more adjustment space between them and making them more adaptable. The plug body is disc-shaped. Since the fixing member 12 is inside the plug body and the connecting member 11 is outside the plug body, the thread forms a smooth curved surface between the connecting member 11 and the fixing member 12. As a result, the entire process of the positioning plug 1 being released from the delivery sheath is a smooth shape similar to a hot air balloon, which grows from small to large, without any protrusions. The release position can be adjusted at any time during the release process without any protruding parts causing damage to the inner wall of the left atrial appendage. In addition, one end of the thread is gathered and fixed to the fixing member 12, and the other end is gathered and fixed to the connecting member 11, so that both ends of each thread are fixed and the relative position between the threads is stable. After being gathered and released, the original weaving uniformity and density can still be maintained, avoiding delamination. At the same time, the two ends of the thread are fixed respectively, but there is no direct constraint between the two ends, so they can move relative to each other, providing a certain degree of flexibility for the deformation of the positioning plug 1. The connector 11 is located outside the positioning plug 1, which facilitates connection with the sealing plug 2. After the positioning plug 1 is released and fixed, it provides a certain deformation space for the positioning plug 1, thereby providing a certain adjustment space for the sealing plug 2. At the same time, the connector 11 and the fixing part 12 are independent of each other, which makes it easier to fine-tune the position of the sealing plug 2.

[0059] In this embodiment, the connecting member 11 and the second connecting member 21 can be configured as a one-time snap-fit ​​mechanical connection or a detachable connection. Before surgery, the corresponding positioning plug 1 and sealing plug 2 can be selected and combined according to requirements, or they can be disassembled and reassembled. In this embodiment, the connecting member 11 is a threaded connector, specifically a threaded post, with corresponding threaded holes provided on the second connecting member 21 of the sealing plug 2 for connection. One end of the sealing plug's thread is gathered and fixed to the second connecting member 21, and the other end is gathered and fixed to the third connecting member 22. The third connecting member 22 is used to connect a delivery device, typically a delivery cable 7. The connection structure, especially the threaded connection structure, allows for free connection before use. The size of the positioning plug 1 and the occlusion plug 2 can be adjusted and selected according to different left atrial appendage morphologies. Assembly can be performed before surgery. For example, a certain brand of occluder has 8 models with specifications ranging from 16 to 30 mm. In this embodiment, with 8 models of positioning plug and occlusion plug each, 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 surgery and the occlusion effect.

[0060]

[0061]

[0062] In this embodiment, both the positioning plug 1 and the sealing plug 2 are woven mesh structures, and the material can be nickel-titanium alloy or other medical materials.

[0063] As a preferred embodiment, the anchoring structure is an anchor hook, which is curled towards one end of the connector. The anchor hook effectively improves the anchoring strength of the occluder, thereby reducing the risk of detachment. The anchor hook 6 is curled towards the outer side of the left atrial appendage. Preferably, the anchor hook 6 of the positioning plug 1 is located outside the outer circumferential midline, that is, biased towards the side of the occluder 2. This ensures that when the positioning plug 1 is partially released (e.g., ...), the anchor hook 6 is positioned on the outer side of the midline of the outer periphery. Figure 9 As shown, the anchor hook 6 is positioned so as not to contact the inner wall of the left atrial appendage. Adjusting the position of the positioning plug 1 in this state prevents the anchor hook from contacting the inner wall of the left atrial appendage. Furthermore, after complete release, the positioning plug 1 is subjected to a certain amount of compression, allowing the anchor hook 6 to better engage and fix with the inner wall of the left atrial appendage. In a preferred embodiment, a flat portion 61 is provided on a portion of the wire of the positioning plug 1. 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. This ensures the anchor hook 6 has a stable orientation, maintaining its preset direction even after folding and release. 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 effect of the anchor hook 6 and the deformable positioning plug 1 effectively improves the anchoring strength of the occluder, thereby reducing the risk of detachment.

[0064] As a preferred embodiment, the plug body is provided with a flow-blocking membrane, which covers the inner wall of the plug body. The flow-blocking membrane on the positioning plug, together with the flow-blocking membrane on the sealing plug, forms a double-layer seal, enhancing the sealing effect. The material of the flow-blocking membrane can be polyethylene terephthalate (PET).

[0065] The usage process of this utility model embodiment is as follows:

[0066] Select appropriate positioning plug 1 and sealing plug 2 according to requirements. Connect positioning plug 1 and sealing plug 2 through connector 11 and second connector 21 to form a segmented plug-type left atrial appendage occluder. Connect the delivery cable 7, with threaded connectors welded to its end, to the third connector 22. Place the segmented plug-type left atrial appendage occluder composed of positioning plug 1 and sealing plug 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 11 As shown, the delivery cable 7 continues to be pushed, and the sealing plug 2 is pushed out of the delivery sheath 4. Since the positioning plug has completed its release and fixation first, the release position and angle of the sealing plug can be adjusted during the pushing process, relying on the positioning plug. By controlling the delivery cable 7, the sealing plug 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 sealing plug 2, which further ensures the flexibility of the sealing plug 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 and thus gets stuck inside the left atrial appendage. The sealing plug 2 is stuck at the opening of the left atrial appendage. The anchor hooks 6 on the outer periphery of the positioning plug 1 and the sealing plug 2 are anchored to the inner wall of the left atrial appendage. The positioning plug 1 and the sealing plug 2 work together with the flow-blocking membrane 3 to block the left atrial appendage and prevent thromboembolism. Finally, the delivery cable 7 is rotated in the opposite direction to separate it from the third 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 within a typical left atrial appendage 8 structure. Figure 12 This is a schematic diagram showing the positioning plug after it has been released into the left atrial appendage. Figure 13 This is a schematic diagram showing the locating plug and the occluder after release within the left atrial appendage 8. Because the occluder described in this embodiment has a double-plug structure, with both the locating plug and the occluder entering the left atrial appendage for fixation, the occlusion surface is flat and has a small area after occlusion, which is more conducive to endometrialization.

[0067] The woven structure of the positioning plug 2 allows the outer plug structure to widen under the compression of the left atrial appendage wall after release, i.e., increasing its thickness. This reduces the radial dimensions corresponding to both bottom surfaces, allowing for flexible deformation and easier attainment of a steady state. The increased deformation due to compression ensures moderate interaction force between the positioning plug 2 and the left atrial appendage wall, facilitating force balance. Furthermore, its tight fit prevents excessive pressure on the left atrial appendage wall, and the increased anchoring thickness ensures more thorough sealing. Figure 14 As shown.

[0068] The release principles of this embodiment include: (1) positioning plug positioning; (2) positioning plug sealing limit, which can play a pulling role and also a sealing limit role; (3) sealing plug is squeezed and widened after release; (4) sealing plug is fixed, the sealing device can be pulled to perform stability test; (5) releasing the sealing device connection to complete the sealing.

[0069] Example 2

[0070] like Figures 15 to 18 As shown, the difference between this embodiment and Embodiment 1 is that the connection between the connector 11 and the second connector 21 is a mechanical plug-in connection.

[0071] As a preferred embodiment, the connector 11 includes a snap-fit ​​member 111 and an elastic connection structure 112. The second 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 sealing plug 2. The snap-fit ​​member 111 can be driven away from the slot 211 by external force to separate the positioning plug 1 from the sealing plug 2.

[0072] Specifically, the 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 second connector 21 during the connection process, thereby improving the connection efficiency of the connector 11 with the second connector 21, and thus improving the connection and assembly efficiency of the positioning plug 1 and the sealing plug 2.

[0073] In a specific embodiment, the slot 211 is a groove structure arranged in the radial direction of the second connector 21, and the slot 211 is connected to the outside. The second 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 sealing plug 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 sealing plug 2 by external force, so that the positioning plug 1 and the sealing plug 2 can be separated. After the positioning plug 1 and the sealing plug 2 are separated, the elastic connection structure 112 drives the snap-fit ​​member 111 to reset.

[0074] When assembling the positioning plug 1 and the sealing plug 2, an external force is used to press the snap-fit ​​member 111 radially inward, compressing the elastic connection structure 112. Then, the connector 11 on the positioning plug 1 is inserted axially into the second connector 21 on the sealing plug 2. During this process, the snap-fit ​​member 111 moves along the inner wall of the second connector 21. When the snap-fit ​​member 111 moves to the position corresponding to the slot 211, most of the component structure of the snap-fit ​​member 111 near the slot 211 will enter the slot 211, while the small portion of the component structure of the snap-fit ​​member 111 away from the slot 211 remains in the first mounting groove. Within 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 connector 11 and the second connector 21, thereby connecting the positioning plug 1 and the sealing plug 2. The snap-fit ​​structure formed by the connector 11 and the second connector 21 can greatly improve the ease of connection and assembly of the positioning plug 1 and the sealing plug 2, and improve the ease of disassembly. At the same time, the snap-fit ​​structure formed by the connector 11 and the second connector 21 can also ensure the reliability of the connection between the positioning plug 1 and the sealing plug 2, and prevent the two from separating unexpectedly during use.

[0075] 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 connector 11 and the second 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.

[0076] 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.

[0077] Example 3

[0078] like Figure 19 and Figure 20 As shown, the difference between this embodiment and Embodiment 1 is that the positioning plug 1 and the sealing plug 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 sealing plug 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 21 As shown, for the early-lobed left atrial appendage 8, the internal space and the opening are usually not coaxial. Due to the fixing and limiting effect of the positioning plug 1 on the sealing plug 2, a certain angle is allowed between the positioning plug 1 and the sealing plug 2 for fixing. In this case, the sealing plug 2 is fixed under the pulling action of the positioning plug 1, or one side of the sealing plug 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.

[0079] Example 4

[0080] like Figure 22 and Figure 23 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 occlusion plug 2. This embodiment is suitable for left atrial appendages 8 where the diameter of the internal space of the tympanic cavity is larger than the diameter of the mouth. 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 it first. Under the limiting and fixing effect of the positioning plug 1, the occlusion plug 2 is released and fixed. Because the positioning plug 1 can limit and fix the occlusion plug 2, the occlusion plug 2 will not dislodge due to its smaller mouth diameter. Other structures, usage methods, and beneficial effects of this embodiment are the same as in Embodiment 1, and will not be repeated here.

[0081] Example 5

[0082] like Figure 24 and Figure 25 As shown, the difference between this embodiment and Embodiment 1 is that in Embodiment 1, the positioning plug 1 is disc-shaped and the sealing plug 2 is drum-shaped, while in this embodiment, both the positioning plug 1 and the sealing plug 2 are drum-shaped. Other structures, usage methods, and beneficial effects of this embodiment are the same as in Embodiment 1, and will not be repeated here.

[0083] Example 6

[0084] like Figure 26 and Figure 27 As shown, the difference between this embodiment and Embodiment 5 is that the main body of the inner plug structure is a drum shape with smooth edges. One side of the inner plug structure 1 gradually tapers inward in a trumpet shape to the fixing member 12, and the other side gradually tapers outward in a trumpet shape to the connecting member 11. Specifically, a tapping, binding, and welding fixing method can be adopted. One end of the wire gradually tapers and binds to the connecting member 11, forming a trumpet-shaped transition section 13 between the connecting member 11 and the plug body. The trumpet-shaped transition section 13 can increase the distance between the positioning plug 1 and the sealing plug 2, leaving more adjustment space between them and making them more adaptable. Other structures, usage methods, and beneficial effects of this embodiment are the same as those of Embodiment 5, and will not be repeated here.

[0085] Example 7

[0086] like Figures 28 to 31 As shown, the difference between this embodiment and Embodiment 1 is that the positioning plug 1 and the sealing plug 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 connecting member 11. For the sealing plug, one end of the laser-engraved wire is gathered outward and fixed to the second connecting member 21, and the other end is gathered outward and fixed to the third connecting member 22. 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.

[0087] 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 32 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 33 As shown; once rollover or extrusion occurs, immediate open-chest surgery is necessary, posing significant risks and pain to the patient. Figure 34 As shown, in this embodiment of the present invention, the inner plug structure 1 is fixed first, generating a multi-directional supporting force f” or accompanied by traction and thrust on the sealing plug 2 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. In this embodiment, the sealing plug 2 is subjected to forces from multiple points, and the force points are not on the same plane, presenting a three-dimensional force state. The force is stable, with no risk of overturning or falling off. After the positioning plug 1 is compressed and deformed, it is anchored inside the left atrial appendage. Since it allows a certain degree of deformation, and the fixing and connecting parts are free from each other, the sealing plug 2 is allowed to be anchored at a certain angle with the inner plug structure. Pushing and pulling forces can also be applied to the sealing plug 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 35 and Figure 36 As shown, for early-lobulated left atrial appendages, if the inner plug of the cap-type occluder is fixed in the unlobulated part, the cap-type occluder will not be able to seal the opening of the left atrial appendage due to insufficient axial space. If the inner plug is fixed in the ventricle of the lobulated part, leakage will occur due to poor coaxiality.

[0088] The connection structure in this embodiment allows for adjustment and selection of the dimensions of the positioning plug 1 and the sealing plug 2 according to different left atrial appendage morphologies. Assembly is performed before surgery, adapting to left atrial appendages of various shapes and sizes. Early-lobulated atrial appendages can also be sealed, ensuring safety, controllability, simple and efficient operation, and guaranteeing surgical success and sealing effectiveness. In all embodiments of this utility model, the positioning plug 1 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 sealing plug is fixed. The sealing plug is either pulled or supported to fix it at the left atrial appendage ventricle orifice, such as... Figure 37 and Figure 38 As shown, once the positioning plug is fixed, it is located inside the left atrial appendage. Therefore, when releasing the occluder, the occluder can be pushed and pulled appropriately to release it in the most suitable 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 changes with the heartbeat during the operation. The application of previous occluders was limited due to the complexity of the atrial appendage). There will be no risk caused by the pushing and pulling action, and the existing release-type occluder does not require positioning and tube withdrawal for release, which makes it difficult to control the position of the occluder.

[0089] 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 on the occluder surface, no residual shunting, no occluder dislodgement or displacement, and no cardiac tamponade. Figures 39 to 41 As 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 42 and Figure 43 As shown, this invention demonstrates high safety and good tissue biocompatibility. In animal experiments using this invention, 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, and all implantation processes are free of cardiac tamponade, making it highly efficient and safe.

[0090] The embodiments described above are merely preferred embodiments of the present utility model and are not intended to limit the scope of the present utility model. Various modifications and improvements made to the technical solutions of the present utility model by those skilled in the art without departing from the spirit of the present utility model should fall within the protection scope defined by the claims of the present utility model.

Claims

1. A positioning plug for a segmented plug-type left atrial appendage occlusion device, characterized in that: It includes a mesh plug, one end of which is provided with a connector for connecting to the sealing plug, and the outer periphery of the plug is provided with an anchoring structure. During release, except for the anchoring structure, the contact form that the plug may form with the left atrial appendage is a smooth surface contact.

2. The positioning plug for the segmented plug-type left atrial appendage occlusion device according to claim 1, characterized in that: The plug is disc-shaped, drum-shaped with smooth edges, or cylindrical with smooth edges. The plug has a woven mesh structure. One end of the plug is folded outward and fixed to the connector, while the other end of the plug is folded inward and fixed to the fixing member. The part of the plug facing away from the anchoring structure is a structure without any protrusions on the surface.

3. The positioning plug for the segmented plug-type left atrial appendage occlusion device according to claim 2, characterized in that: The plug is a plug-like structure made of intersecting threads that are inclined in two directions. One end of the threads is gathered and tied to the fixing member, and the other end is gathered and tied to the connector.

4. The positioning plug for the segmented plug-type left atrial appendage occlusion device according to claim 3, characterized in that: One end of the thread gradually converges and is tied to the connector, forming a trumpet-shaped transition section between the connector and the plug.

5. The positioning plug for the segmented plug-type left atrial appendage occlusion device according to claim 4, characterized in that: The plug is disc-shaped, and the filaments form a smooth curved surface between the connector and the fixing member.

6. The positioning plug for the segmented plug-type left atrial appendage occluder according to any one of claims 1 to 5, characterized in that: The connector is a threaded connector or a mechanical plug connector.

7. The positioning plug for the segmented plug-type left atrial appendage occluder according to any one of claims 1 to 5, characterized in that: The connector is a detachable connector.

8. The positioning plug for the segmented 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 connector.

9. The positioning plug for the segmented plug-type left atrial appendage occluder according to claim 1, characterized in that: The plug body is provided with a flow-blocking membrane, which covers the inner wall of the plug body.

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