Segmented plug left atrial appendage occluder and left atrial appendage occlusion system

Abstract

The utility model discloses a kind of segmented plug type left auricle plugging device and left auricle plugging system, the segmented plug type left auricle plugging device includes the inner plug structure and outer plug structure by connecting structure interconnection, the inner plug structure and outer plug structure are the mesh plug body structure that can enter left auricle inside fixed, the inner plug structure can play the role of limiting and fixed to plugging device, flow resistance film is equipped on the outer plug structure, the outer periphery of the inner plug structure and outer plug structure is equipped with anchoring structure.The segmented plug type left auricle plugging device of the utility model is by segmentedly setting inner plug structure and outer plug structure, double plug cooperation is carried out plugging positioning, play the role of mutual support in release process, especially in the process of releasing outer plug structure, outer plug structure is based on inner plug structure, the position of outer plug structure is adjusted, to obtain better plugging effect, avoid turning over, improve the success rate of operation.

Description

Technical Field

[0001] This utility model relates to the field of left atrial appendage occlusion technology, specifically to a segmented plug-type left atrial appendage occluder and a left atrial appendage occlusion system. 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 researching and designing a segmented plug-type left atrial appendage occlusion device and a left atrial appendage occlusion system. The technical means employed in this invention are as follows:

[0006] A segmented plug-type left atrial appendage occluder includes an inner plug structure and an outer plug structure interconnected by a connecting structure. Both the inner plug structure and the outer plug structure are mesh plug structures that can enter and fix inside the left atrial appendage. The inner plug structure can limit and fix the occluder. The outer plug structure is provided with a flow-blocking membrane. The outer periphery of the inner plug structure and the outer plug structure is provided with an anchoring structure.

[0007] Furthermore, the inner plug structure and the outer plug structure are each independently shaped as a disc, a drum with smooth edges, a cylinder with smooth edges, or a frustum with smooth edges.

[0008] Furthermore, the connection structure is a structure for combining and connecting the inner plug structure and the outer plug structure before use.

[0009] Furthermore, the connection structure includes a first connector fixed to the inner plug structure and a second connector fixed to the outer plug structure. The first connector and the second connector are mechanically connected. Both the inner plug structure and the outer plug structure are provided with flow-blocking membranes. The side of the outer plug structure away from the inner plug structure is provided with a third connector for connecting a delivery device.

[0010] Furthermore, the first connector and the second connector are connected by a mechanical plug or a threaded connection.

[0011] Furthermore, the connection structure is a detachable connection structure.

[0012] Furthermore, during the release process, apart from the anchoring structure, the inner plug structure may form a smooth surface contact with the left atrial appendage.

[0013] Furthermore, both the inner and outer plug structures are metal woven mesh structures or laser-engraved mesh structures. The main body of the inner plug structure is disc-shaped, drum-shaped with smooth edges, or cylindrical. One side of the inner plug structure is drawn inward to the fixing member, and the other side of the inner plug structure is drawn outward to the first connecting member. The main body of the outer plug structure is drum-shaped or cylindrical with smooth edges. One side of the outer plug structure is drawn in and fixed to the second connecting member. The first connecting member and the second connecting member are mechanically inserted or threadedly connected, preferably detachable mechanically inserted or threadedly connected. The other side of the outer plug structure is drawn in and fixed to the third connecting member, which is used to connect the conveying device.

[0014] Furthermore, the first connector and the second connector are connected by threads, and the third connector and the conveying device are connected by threads.

[0015] Furthermore, both the inner and outer plug structures are plug-like structures formed by interlacing filaments inclined in two directions. One end of the filaments of the inner plug structure is gathered and tied to the fixing member, and the other end is gathered and tied to the first connecting member, forming a smooth curved surface between the first connecting member and the fixing member. One end of the filaments of the outer plug structure is gathered and tied to the second connecting member, and the other end is gathered and tied to the third connecting member. The porosity of the inner plug structure is greater than that of the outer plug structure.

[0016] Furthermore, the anchoring structure is an anchor hook, which is curled towards the outer side of the left atrial appendage. The inner plug structure has one anchor hook, and the outer plug structure has two anchor hooks.

[0017] A left atrial appendage occlusion system includes the segmented plug-type left atrial appendage occluder described in this utility model, and also includes a delivery sheath and a delivery device, wherein the delivery device is adapted to the segmented plug-type left atrial appendage occluder.

[0018] Furthermore, the conveying device is a conveying steel cable, which is connected to the outer plug structure via threads.

[0019] A method of using a segmented plug-type left atrial appendage occluder, for use with the segmented plug-type left atrial appendage occluder described in this utility model, includes the following steps:

[0020] Connect the segmented plug-type left atrial appendage occluder to the delivery device;

[0021] Insert the segmented plug-type left atrial appendage occluder into the delivery sheath;

[0022] Push the delivery device until the inner plug structure is released, and adjust the position and / or angle of the inner plug structure;

[0023] Push the delivery device until the inner plug structure is fully released and fixed;

[0024] Push the delivery device until the outer plug structure is released, and adjust the position and / or angle of the outer plug structure;

[0025] Push the conveying device until the outer plug structure is fully released and fixed.

[0026] Furthermore, the connection structure includes a first connector fixed to the inner plug structure and a second connector fixed to the outer plug structure. The first connector and the second connector are mechanically connected. The method of use further includes the following steps: selecting an inner plug structure and an outer plug structure of the required specifications, connecting the first connector and the second connector to obtain a segmented plug-type left atrial appendage occluder.

[0027] Compared with existing technologies, the segmented plug-type left atrial appendage occluder of this utility model uses a segmented inner plug structure and an outer plug structure. The two plugs work together for occlusion and positioning, and play a supporting role during the release process. In particular, during the release of the outer plug structure, the outer plug structure relies on the inner plug structure to adjust the position of the outer plug structure, so as to obtain a better occlusion effect, avoid overturning, and improve the success rate of the operation. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment 1 of this utility model.

[0029] Figure 2 This is a schematic diagram of the inner plug structure described in Embodiment 1 of this utility model.

[0030] Figure 3 yes Figure 2 Top view.

[0031] Figure 4 yes Figure 2 Enlarged view of point A.

[0032] Figure 5 yes Figure 2 Enlarged view of point B.

[0033] Figure 6 This is a schematic diagram of the outer plug structure described in Embodiment 1 of this utility model.

[0034] Figure 7 yes Figure 6 Top view.

[0035] Figure 8 This is a schematic diagram of the shape of the inner and outer plug structures inside the sheath during the self-conveying sheath release process of Embodiment 1 of this utility model.

[0036] Figure 9 This is a schematic diagram of the shape of the inner plug structure being partially pushed out of the sheath and the outer plug structure still inside the sheath during the self-delivery sheath release process of this utility model embodiment.

[0037] Figure 10 This is a schematic diagram of the shape of the inner plug structure being pushed out of the sheath and the outer plug structure still inside the sheath during the self-conveying sheath release process of this utility model embodiment.

[0038] Figure 11 This is a schematic diagram of the shape when both the inner and outer plug structures of the self-conveying sheath are pushed out of the sheath to achieve release, according to an embodiment of this utility model.

[0039] Figure 12This is a schematic diagram of the anchoring state inside the left atrial appendage structure in Embodiment 1 of this utility model (the inner plug structure has been released, and the outer plug structure has not been released).

[0040] Figure 13 This is a schematic diagram of the anchoring state inside the left atrial appendage structure in Embodiment 1 of this utility model (both the inner and outer plug structures have been released).

[0041] 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.

[0042] Figure 15 This is a schematic diagram of the outer plug structure described in Embodiment 2 of this utility model.

[0043] Figure 16 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment 3 of this utility model.

[0044] Figure 17 This is a schematic diagram of the structure of the first connector described in Embodiment 3 of this utility model.

[0045] Figure 18 This is a schematic diagram of the structure of the second connector described in Embodiment 3 of this utility model.

[0046] Figure 19 This is a schematic diagram of the structure after the first connector and the second connector are mechanically inserted, as described in Embodiment 3 of this utility model.

[0047] Figure 20 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment 4 of this utility model.

[0048] 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 inner and outer plug structures have been released).

[0049] 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 inner and outer plug structures have been released).

[0050] Figure 23 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment 5 of this utility model.

[0051] 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 inner and outer plug structures have been released).

[0052] Figure 25 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment Six of this utility model.

[0053] Figure 26 This is a schematic diagram of the anchoring state inside the left atrial appendage structure in Embodiment Six of this utility model (both the inner and outer plug structures have been released).

[0054] Figure 27 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment 7 of this utility model.

[0055] Figure 28 This is a schematic diagram of the anchoring state inside the left atrial appendage structure in Embodiment 7 of this utility model (both the inner and outer plug structures have been released).

[0056] Figure 29 This is a schematic diagram of the segmented plug-type left atrial appendage occluder described in Embodiment 8 of this utility model.

[0057] Figure 30 This is a schematic diagram of the inner plug structure described in Embodiment 8 of this utility model.

[0058] Figure 31 This is a schematic diagram of the outer plug structure described in Embodiment 8 of this utility model.

[0059] Figure 32 This is a schematic diagram of the anchoring state inside the left atrial appendage structure in Embodiment 8 of this utility model.

[0060] Figure 33 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.

[0061] Figure 34 This is a schematic diagram of the anchoring force of a thick plug-type left atrial appendage occluder in the existing technology.

[0062] Figure 35 This is a schematic diagram of the forces acting on an embodiment of the present invention in the anchored state.

[0063] Figure 36 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).

[0064] Figure 37 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).

[0065] Figure 38 This is a schematic diagram of the outer plug structure being anchored under the pulling action of the inner plug structure according to an embodiment of the present invention.

[0066] Figure 39 This is a schematic diagram of the outer plug structure being anchored under the supporting and limiting effect of the inner plug structure according to an embodiment of the present invention.

[0067] Figures 40 to 42 These are anatomical images of three animals one month after implantation in an animal experiment according to an embodiment of this utility model.

[0068] Figure 43 and Figure 44 This is an anatomical diagram of an animal experiment three months after implantation in an embodiment of this utility model. Detailed Implementation

[0069] Example 1

[0070] like Figures 1 to 7 As shown, a segmented plug-type left atrial appendage occlusion device includes an inner plug structure 1 and an outer plug structure 2 connected to each other. Both the inner plug structure 1 and the outer plug structure 2 are mesh plug structures that can enter the interior of the left atrial appendage. The outer plug structure 2 is provided with a flow-blocking membrane 3. The connection between the inner plug structure 1 and the outer plug structure 2 is closed and fixed to a connecting structure 5. This embodiment is a double-plug structure. When the inner plug structure 1 is released, the outer plug structure 2 is still inside the delivery sheath 4, which plays a certain stabilizing role for the inner plug structure 1. After the inner plug structure 1 is released, it plays a role in positioning, blocking and supporting. After being fixed, it provides support and blocking for the outer plug structure 2. During the release of the outer plug structure 2, the position of the outer plug structure 2 can be adjusted with the inner plug structure 1 as support to obtain a better blocking effect, and there is no risk of overturning. At the same time, under the blocking and support of the inner plug structure 1, no damage will be caused to the inner wall of the left atrial appendage. This invention, through the cooperation of the inner plug structure 1 and the outer plug structure 2, allows for the initial release and fixation of the inner plug structure. Using the inner plug structure as a support and sealing limiting structure, the release position and angle of the outer plug structure can be adjusted. It also allows for the release of the outer plug structure under axial thrust or tension, ensuring the accuracy of its release position and the adequacy of the sealing. Under the limiting and supporting effect of the inner plug structure, the outer plug structure 2 achieves sealing with the inner wall of the left atrial appendage through radial interaction force. It has low requirements for coaxiality and no risk of overturning. Furthermore, the inner and outer plug structures can be set to different sizes to adapt to the internal shape of the left atrial appendage, achieving a better sealing effect. The flow-blocking membrane can be made of polyethylene terephthalate (PET), which is attached to the inner surface of the outer plug structure.

[0071] As a preferred embodiment, a connecting structure 5 is provided between the inner plug structure 1 and the outer plug structure 2, and the opposing surfaces of the inner plug structure 1 and the outer plug structure 2 are all closed and fixed to the connecting structure 5. The shapes of the inner plug structure and the outer plug structure of this utility model only need to meet the sealing requirements. Preferably, the plug body of the inner plug structure and the outer plug structure includes two circular bottom surfaces and side surfaces smoothly connected to the two bottom surfaces. The side surfaces are smooth curved surfaces. Preferably, the inner plug structure 1 and the outer plug structure 2 are each independently configured as a disc shape, a drum shape with smooth edges, a cylinder shape with smooth edges, or a frustum shape with smooth edges. In this embodiment, the disc shape is a shape with two circles as the upper and lower bottom surfaces, and a curved surface with a generatrix as a circular arc or elliptical arc as the side surface, and the side surface is tangent to the bottom surface. In this embodiment, the drum shape is a shape with two circles as the bottom surface, and a curved surface with a generatrix as a circular arc or elliptical arc as the side surface, and the bottom surface and the side surface are not tangent. The connecting structure 5 is a structure used to combine and connect inner plug structures 1 and outer plug structures 2 of different specifications before use. The dimensions of the inner plug structure 1 and the outer plug structure 2 can be adjusted and selected according to different left atrial appendage morphologies. They can be assembled before surgery to adapt to more types of left atrial appendages. For example, a certain brand of occluder has 8 models with specifications ranging from 16 to 30 mm. With 8 models of both the inner plug structure and the outer plug structure in this application, 64 models of left atrial appendage occluders can be assembled, as shown in the table below. This adapts to 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.

[0072]

[0073]

[0074] In this embodiment, the inner plug structure and the outer plug structure can be fixedly connected, or the connecting structure 5 can be set as a one-time snap-fit ​​mechanical connection or a detachable connection. As a preferred embodiment, the connecting structure 5 includes a first connecting member 51 fixed to the inner plug structure 1 and a second connecting member 52 fixed to the outer plug structure 2. The first connecting member 51 and the second connecting member 52 are mechanically connected, specifically, it can be a one-time mechanical connection or a detachable connection, more preferably a detachable connection structure. The corresponding inner plug structure 1 and outer plug structure 2 can be selected and combined before surgery according to needs, or they can be disassembled and reassembled. Both the inner plug structure 1 and the outer plug structure 2 are provided with a flow-blocking membrane 3, which can be disposed inside the inner plug structure 1 and the outer plug structure 2 or on the outside.

[0075] As a preferred embodiment, the outer periphery of the inner plug structure 1 and the part facing away from the outer plug structure 2 are structures without protrusions on the surface. This ensures that the part of the inner plug structure 1 that can contact the inner wall of the left atrial appendage during the entire release process is free of protrusions. In particular, in the semi-release state, all forms of contact that the inner plug structure may form with the left atrial appendage are smooth surface contacts. There will be no protrusions or sharp angles that form point or line contacts with the left atrial appendage. This facilitates the adjustment of the release position of the inner plug structure 1 in the semi-release state and avoids damage to the left atrial appendage. In this embodiment, both the inner plug structure 1 and the outer plug structure 2 are woven mesh structures, made of nickel-titanium alloy or other medical materials. The main body of the inner plug structure 1 is disc-shaped, drum-shaped with smooth edges, or cylindrical. One side of the inner plug structure 1 converges inward to the fixing member 11. In this embodiment, the fixing member 11 is a fixing cap. The other side of the inner plug structure 1 converges outward to the first connecting member 51. Preferably, one side of the inner plug structure 1 gradually converges inward in a trumpet shape to the fixing member 11, and the other side gradually converges outward in a trumpet shape to the first connecting member 51. A trumpet-shaped transition section is formed between the first connecting member and the main body of the inner plug structure 1. A smooth curved surface is formed between the first connecting member 51 and the fixing member 11, forming a shape similar to a flat hot air balloon or a flat heart. The fixing member 11 is disposed inside the inner plug structure 1. The inner plug structure 1 is designed so that it maintains a smooth, spherical, hot air balloon-like, or heart-shaped form throughout its release from the delivery sheath, without any protrusions. This allows for adjustments to the release position at any time during the release process without any protrusions damaging the inner wall of the left atrial appendage. Furthermore, the inner plug structure is woven from symmetrically inclined threads in two directions. All threads pass through the first connector 51 to the fixing member 11. One end of each thread is gathered, bound, and welded to the fixing member 11, while the other end is gathered, bound, and welded to the first connector 51. This ensures that both ends of each thread are fixed, maintaining a stable relative position between the threads. After being gathered and unwound, the original uniformity and density of the weaving are preserved, preventing fraying. At the same time, while both ends of the threads are fixed, they are not directly constrained to each other, allowing for relative movement and providing flexibility for the deformation of the inner plug structure. The first connector 51 is located on the outside of the inner plug structure 1, facilitating connection with the outer plug structure 2. After the inner plug structure 1 is released and fixed, it provides a certain deformation space for the inner plug structure 1, thus preserving a certain adjustment space for the outer plug structure 2. Furthermore, the first connector 51 and the fixing member 11 are independent of each other, making it easier to fine-tune the position of the outer plug structure 2. Additionally, the flared transition section increases the distance between the inner plug structure 1 and the outer plug structure 2, providing more adjustment space and greater adaptability. The main body of the outer plug structure 2 is a smooth-edged drum or cylinder shape. One side of the outer plug structure 2 is closed and fixed to the second connector 52, and the other side is closed and fixed to the third connector 21. The third connector 21 is used to connect a conveying device, commonly a conveying steel cable 7.Similarly, both ends of each thread in the outer plug structure are fixed, and the position between the threads is stable. After being wound and unwound, it can still maintain the original weaving uniformity and density, avoiding fraying. In this embodiment, the parts of the inner plug structure 1 that can contact the inner wall of the left atrial appendage have no protrusions. During the release process, it can be partially released from the inner plug structure (e.g.). Figure 9 (As shown) The position can be further adjusted without damaging the inner wall of the left atrial appendage. Damage to the inner wall of the left atrial appendage is avoided even under dynamic cardiac beating conditions or reasonable errors in the operation force. Even if the inner plug structure is squeezed or shaken during the adjustment process, no protrusion structure will be generated. The fixing member 11 and the first connecting member 51 independently fix the threads of the inner plug structure, which not only ensures the stability of the inner plug structure 1 and its support and sealing protection effect, but also retains a certain degree of deformation flexibility for the inner plug structure 1, leaving space for the adjustment of the outer plug structure 2.

[0076] As a preferred embodiment, the first connecting member 51 and the second connecting member 52 are connected by threads, and the third connecting member 21 is connected to the delivery device by threads. Specifically, a threaded post can be provided on the first connecting member 51, and a threaded hole can be provided on the second connecting member 52. The threads between the first connecting member 51 and the second connecting member 52 and the threads between the third connecting member 21 and the delivery device can be in the same direction or opposite directions. If necessary, they can be set to opposite directions to avoid loosening between the first connecting member 51 and the second connecting member 52 when rotating and disassembling the delivery device. The threaded connection method is simple to operate and provides a stable connection. Suitable inner plug structure 1 and outer plug structure 2 can be selected according to the morphology of the patient's left atrial appendage for rapid assembly. Preferably, the porosity of the inner plug structure is greater than that of the outer plug structure, that is, the weaving density of the inner plug structure is lower than that of the outer plug structure, ensuring that the inner plug structure can adaptively deform according to the internal structure of the left atrial appendage.

[0077] As a preferred embodiment, both the inner plug structure 1 and the outer plug structure 2 are provided with anchor hooks 6 on their outer peripheries. The anchor hooks effectively improve the anchoring strength of the occluder, thereby reducing the risk of dislodgement. The anchor hooks 6 are curled towards the outer side of the left atrial appendage. Preferably, the anchor hooks 6 of the inner plug structure 1 are located outside the midline of its outer periphery, that is, biased towards the outer plug structure 2. This ensures that when the inner plug structure 1 is partially released (e.g., ...), the anchor hooks 6 are positioned on the outer side of its outer periphery. Figure 9 As shown, the anchor hook 6 is in a position that will not contact the inner wall of the left atrial appendage. In this state, the position of the inner plug structure 1 is adjusted to avoid the anchor hook contacting the inner wall of the left atrial appendage. Furthermore, after the inner plug structure 1 is fully released and subjected to a certain amount of compression, the anchor hook 6 can better cooperate and fix with the inner wall of the left atrial appendage.

[0078] As a preferred embodiment, some of the threads of the inner plug structure 1 and the outer plug structure 2 are provided with flat portions 61, and the anchor hook 6 is a hook-shaped structure formed by laser engraving and curling from the flat portions. The flat portions 61 can be formed by forging the thread portion, so that the anchor hook 6 is oriented stably and can maintain the preset direction after folding and releasing. Moreover, when folded and retracted into the delivery sheath, the anchor hook can straighten back to the laser-engraved hollow portion without occupying more space. The combined effect of the anchor hook 6 and the deformable inner plug structure 1 can effectively improve the anchoring strength of the plugger, thereby reducing the risk of dislodgement.

[0079] The usage process of this embodiment is as follows:

[0080] Select suitable inner plug structure 1 and outer plug structure 2 according to requirements. Connect inner plug structure 1 and outer plug structure 2 through first connector 51 and second connector 52 to assemble a segmented plug-type left atrial appendage occluder. Connect the delivery cable with threaded connectors welded to its end to the third connector 21. Place the segmented plug-type left atrial appendage occluder 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 diagram illustrates the state during release where the inner plug structure 1 is pushed out of the delivery sheath, forming a smooth, protrusion-free structure. Specifically, it can be spherical, balloon-shaped, or a three-dimensional heart-shaped structure. The anchor hook 6 retracts inward near the center to avoid damage to the left atrial appendage. Since the inner plug structure maintains a smooth surface contact with the inner wall of the left atrial appendage during release, its position can be adjusted in this state to ensure more accurate release while maintaining safety. The delivery cable continues to be pushed until the inner plug structure is fully released and secured. Figure 10 This is a schematic diagram showing the inner plug structure 1 fully extended from the delivery sheath 4 and deployed. The smooth structure of the inner plug structure 1 avoids damage to the left atrial appendage; as shown... Figure 11As shown, the delivery cable 7 continues to be pushed, and the outer plug structure 2 is pushed out of the delivery sheath 4. Since the inner plug structure has completed its release and fixation first, the release position and angle of the outer plug structure can be adjusted during the pushing process, relying on the inner plug structure. By controlling the delivery cable 7, the outer plug structure can be pushed to compress, stretch, or radially adjust to better seal the opening of the left atrial appendage. At the same time, since the front end of the inner plug structure has no protrusion and is fixed first, under the limiting and fixing effect of the inner plug structure, there is no safety hazard of puncturing the inner wall of the left atrial appendage when axially compressing and adjusting the outer plug structure. This further ensures the flexibility of the outer plug structure adjustment, and the operation process is easy to control, safe and reliable. The inner plug structure 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 outer plug structure 2 gets stuck at the opening of the left atrial appendage. The anchor hooks 6 on the outer periphery of the inner plug structure 1 and the outer plug structure 2 anchor the inner wall of the left atrial appendage. The inner plug structure 1 and the outer plug structure 2 work together with the flow-blocking membrane 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 21. 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 structure. Figure 12 This is a schematic diagram of the internal plug structure after it is released within the left atrial appendage. Figure 13 This is a schematic diagram showing the inner and outer plug structures after release within the left atrial appendage. Because this embodiment uses a dual-plug structure, with both the inner and outer plug structures entering and securing themselves inside the left atrial appendage, the resulting sealing surface is flat and has a small area, which is more conducive to endometrialization.

[0081] The woven structure of the outer plug structure 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 of both bottom surfaces, making it more flexible in deformation and easier to reach a steady state. The increased deformation due to compression ensures moderate interaction forces between the outer plug structure 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 complete sealing. Figure 14 As shown.

[0082] The release principles of this embodiment include: (1) positioning of the inner plug structure; (2) sealing and limiting of the inner plug structure, which can play a pulling role and also a sealing and limiting role; (3) the outer plug structure becomes wider after sealing and releasing, that is, the thickness becomes larger; (4) after the outer plug structure is fixed, the plug can be pulled to perform stability testing; (5) release the plug connection to complete the sealing.

[0083] Example 2

[0084] like Figure 15As shown, the difference between this embodiment and Embodiment 1 is that the middle part of the outer end face of the outer plug structure 2 can be provided with a concave structure 22, and the third connector 21 is provided at the concave structure 22. After sealing, the third connector does not protrude from the outer end face of the outer plug structure 2, which is beneficial to postoperative endometrialization. This utility model can provide concave structures on both sides of the outer plug structure as needed. Other structures, usage methods and beneficial effects of this embodiment are the same as those of Embodiment 1, and will not be repeated here.

[0085] Example 3

[0086] like Figures 16 to 19 As shown, the difference between this embodiment and Embodiment 1 is that the structure of the connecting structure 5 is different. In this embodiment, the connection between the first connecting member 51 and the second connecting member 52 is a mechanical plug-in connection, preferably a detachable mechanical plug-in connection.

[0087] As a preferred embodiment, the first connector 51 includes a snap-fit ​​member 511 and an elastic connection structure 512, and the second connector 52 has a slot 521. The snap-fit ​​member 511 can enter the slot 521 under the elastic force of the elastic connection structure 512 to realize the connection between the inner plug structure 1 and the outer plug structure 2. The snap-fit ​​member 511 can be driven away from the slot 521 by external force to separate the inner plug structure 1 from the outer plug structure 2.

[0088] Specifically, the first connector 51 further includes a first snap-fit ​​portion 513 with a cylindrical structure. The first snap-fit ​​portion 513 has a first mounting groove 514 with an opening radially outward. The snap-fit ​​member 511 is installed in the first mounting groove 514 through an elastic connection structure 512. The elastic connection structure 512 can drive the snap-fit ​​member 511 to slide radially outward along the groove wall of the first mounting groove 514, and allow the end of the snap-fit ​​member 511 away from the elastic connection structure 512 to enter the snap-fit ​​groove 521. In this embodiment, the end face of the snap-fit ​​member 511 away from the elastic connection structure 512 is a smooth cylindrical surface, which facilitates the quick installation of the snap-fit ​​member 511 into the second connector 52 during the connection process between the first connector 51 and the second connector 52. This improves the connection efficiency between the first connector 51 and the second connector 52, thereby improving the connection and assembly efficiency between the inner plug structure 1 and the outer plug structure 2.

[0089] In a specific embodiment, the slot 521 is a groove structure arranged in the radial direction of the second connector 52, and the slot 521 is connected to the outside. The second connector 52 is a column structure. The slot 521 structure, which is connected to the outside, facilitates the disassembly and separation of the inner plug structure 1 and the outer plug structure 2. When external force is applied to the outside of the slot 521, the snap-fit ​​member 511 on the inner plug structure 1 is driven to move towards the first mounting groove 514. The snap-fit ​​member is squeezed inward through the slot, and the snap-fit ​​member 511 is pushed out of the slot 521. At this time, the elastic connection structure 512 is compressed. Then, the inner plug structure 1 is driven to move away from the outer plug structure 2 by external force, so that the inner plug structure 1 and the outer plug structure 2 can be separated. After the inner plug structure 1 and the outer plug structure 2 are separated, the elastic connection structure 512 drives the snap-fit ​​member 511 to reset.

[0090] When assembling the inner plug structure 1 and the outer plug structure 2, an external force presses the locking member 511 radially inward, compressing the elastic connection structure 512. Then, the first connecting member 51 on the inner plug structure 1 is inserted axially into the second connecting member 52 on the outer plug structure 2. During this process, the locking member 511 moves along the inner wall of the second connecting member 52. When the locking member 511 moves to the position corresponding to the slot 521, most of the component structure of the locking member 511 near the slot 521 will enter the slot 521, while the small portion of the component structure of the locking member 511 away from the slot 521 remains in the first mounting groove 514. The snap-fit ​​component 511 engages with the inner wall of the first mounting groove 514 and the inner wall of the snap-fit ​​groove 521 to achieve the snap-fit ​​between the first connector 51 and the second connector 52, thereby connecting the inner plug structure 1 and the outer plug structure 2. The snap-fit ​​structure formed by the first connector 51 and the second connector 52 can greatly improve the ease of connection and assembly of the inner plug structure 1 and the outer plug structure 2, and improve the ease of disassembly. At the same time, the snap-fit ​​structure formed by the first connector 51 and the second connector 52 can also ensure the reliability of the connection between the inner plug structure 1 and the outer plug structure 2, and prevent the two from separating unexpectedly during use.

[0091] In a specific embodiment, at least two snap-fit ​​members 511 are symmetrically provided on the first snap-fit ​​portion 513. The number of snap-fit ​​slots 521 is the same as the number of snap-fit ​​members 511, that is, at least one pair of snap-fit ​​members 511 and elastic connecting structures 112 are symmetrically provided on the first snap-fit ​​portion 513 to cooperate with the snap-fit ​​slots 521, thereby ensuring the stability and reliability of the connection between the first connector 51 and the second connector 52. In this embodiment, two snap-fit ​​members 511, two elastic connecting structures 512 and two snap-fit ​​slot structures 521 are symmetrically provided.

[0092] 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.

[0093] Example 4

[0094] like Figure 20 and Figure 21 As shown, the difference between this embodiment and Embodiment 1 is that the inner plug structure 1 and the outer plug structure 2 in Embodiment 1 have the same diameter, while the diameter of the inner plug structure 1 in this embodiment is smaller than the diameter of the outer plug structure 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 orifice are usually not well coaxial. Due to the fixing and limiting effect of the inner plug structure 1 and the outer plug structure 2 of this utility model, a certain angle is allowed between the inner plug structure 1 and the outer plug structure 2 for fixing. In this case, the outer plug structure 2 is fixed under the pulling action of the inner plug structure 1, or one side of the outer plug structure 2 is limited by the inner plug structure 1, and the other side is pulled by the inner plug structure 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.

[0095] Example 5

[0096] like Figure 23 and Figure 24 As shown, the difference between this embodiment and Embodiment 1 is that the diameter of the inner plug structure 1 in this embodiment is larger than the diameter of the outer plug structure 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 inner plug structure 1 for initial release and fixation. Under the limiting and fixing effect of the inner plug structure 1, the outer plug structure 2 is released and fixed. Because the inner plug structure 1 can limit and fix the outer plug structure 2, the outer plug structure 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.

[0097] Example 6

[0098] like Figure 25 and Figure 26 As shown, the difference between this embodiment and Embodiment 1 is that in Embodiment 1, the inner plug structure 1 is disc-shaped and the outer plug structure 2 is drum-shaped, while in this embodiment, both the inner plug structure 1 and the outer plug structure 2 are drum-shaped. For the drum-shaped inner plug structure 1, the fixing member 11 is also disposed inside the inner plug structure. One end of the wire of the inner plug structure is gathered inward, bundled, and welded to the fixing member 11, and the other end of the wire is gathered outward, bundled, and welded to the first connecting member 51. Similarly, in this embodiment, there are no protrusions in the parts of the inner plug structure 1 that can contact the inner wall of the left atrial appendage. During the release process, the inner plug structure can be partially released (e.g., Figure 9 (As shown) The position can be further adjusted without damaging the inner wall of the left atrial appendage. Damage to the inner wall of the left atrial appendage is avoided even under dynamic cardiac rhythm or reasonable errors in the force applied during adjustment. Even if the inner plug structure is squeezed or shaken during adjustment, no protrusion will occur. The fixing member 11 and the first connecting member 51 independently fix the threads of the inner plug structure, ensuring the stability of the inner plug structure 1, guaranteeing its support and sealing protection effect, while also retaining a certain degree of deformation flexibility for the inner plug structure 1, leaving space for the adjustment of the outer plug structure 2. Other structures, usage methods, and beneficial effects of this embodiment are the same as in Embodiment 1, and will not be repeated here.

[0099] Example 7

[0100] like Figure 27 and Figure 28 As shown, the difference between this embodiment and Embodiment Six 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 narrows inward in a trumpet shape to the fixing member 11, and the other side gradually narrows outward in a trumpet shape to the first connecting member 51. A trumpet-shaped transition section is formed between the first connecting member and the main body of the inner plug structure 1. The trumpet-shaped transition section can increase the distance between the inner plug structure 1 and the outer plug structure 2, leaving more adjustment space between them and making them more adaptable. The other structures, usage methods, and beneficial effects of this embodiment are the same as those of Embodiment Six, and will not be repeated here.

[0101] Example 8

[0102] like Figures 29 to 32 As shown, the difference between this embodiment and Embodiment 1 is that the inner plug structure 1 and the outer plug structure 2 in this embodiment are laser-engraved mesh structures. For the inner plug structure 1, one end of the laser-engraved wire is gathered inward and welded to the fixing member 11, and the other end is gathered outward and welded to the first connecting member 51. For the outer plug structure, one end of the laser-engraved wire is gathered outward and fixed to the second connecting member 52, and the other end is gathered outward and fixed to the third connecting member 21. 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.

[0103] 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 33 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 34 As shown; once rollover or extrusion occurs, immediate open-chest surgery is necessary, posing significant risks and pain to the patient. Figure 35As shown, in this embodiment of the present invention, the inner plug structure 1 is fixed first, and generates a multi-directional supporting force f” or accompanied by traction and thrust on the outer plug structure 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 outer plug structure 2 is subjected to forces from multiple points, and the force points are not on the same plane, so it is in a three-dimensional force state. The force is stable and there is no risk of overturning or falling off. After the inner plug structure 1 is compressed and deformed, it is anchored inside the left atrial appendage. Since it allows a certain amount of deformation, and the fixing member and the first connecting member are free from each other, the outer plug structure 2 is allowed to be anchored at a certain angle with the inner plug structure. It can also apply a pushing and pulling force to the outer plug structure 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 36 and Figure 37 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.

[0104] In all embodiments of this utility model, the inner plug structure is used to limit and fix the entire plug body. Fixing means that after the inner plug structure is released and fixed, the outer plug structure is fixed at its release position. The outer plug structure is either pulled to fix it at the left atrial appendage ventricle orifice, or supported to fix it at the left atrial appendage ventricle orifice. Figure 38 and Figure 39 As shown, the inner plug structure is fixed in place. Since the inner plug structure is fixed inside the left atrial appendage, the outer plug structure can be pushed and pulled appropriately during the release process 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 position of the occluder will not be difficult to control due to the positioning and withdrawal of the tube required for the release of the existing inner plug occluder.

[0105] 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 reached 100%, with no residual shunt. Furthermore, the operation process is easy to control and safe and reliable. One month post-surgery, necropsy of the animals revealed no thrombus on the occluder surface, no residual shunt, no occluder dislodgement or displacement, and no cardiac tamponade. Figures 40 to 42 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 43 and Figure 44 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.

[0106] 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 segmented plug-type left atrial appendage occlusion device, characterized in that: It includes an inner plug structure and an outer plug structure that are interconnected by a connecting structure. Both the inner plug structure and the outer plug structure are mesh plug structures that can enter and fix inside the left atrial appendage. The inner plug structure can limit and fix the occluder. The outer plug structure is provided with a flow-blocking membrane. The outer periphery of the inner plug structure and the outer plug structure is provided with an anchoring structure.

2. The segmented plug-type left atrial appendage occluder according to claim 1, characterized in that: The inner plug structure and the outer plug structure are each independently shaped as a disc, a drum with smooth edges, a cylinder with smooth edges, or a frustum with smooth edges.

3. The segmented plug-type left atrial appendage occluder according to claim 2, characterized in that: The connection structure is used to combine and connect the inner plug structure and the outer plug structure before use.

4. The segmented plug-type left atrial appendage occluder according to claim 3, characterized in that: The connection structure includes a first connector fixed to the inner plug structure and a second connector fixed to the outer plug structure. The first connector and the second connector are mechanically connected. Both the inner plug structure and the outer plug structure are provided with flow-blocking membranes. The outer plug structure is provided with a third connector for connecting a delivery device on the side away from the inner plug structure.

5. The segmented plug-type left atrial appendage occluder according to claim 4, characterized in that: The first connector and the second connector are connected by mechanical insertion or thread.

6. The segmented plug-type left atrial appendage occluder according to claim 3, characterized in that: The connection structure is a detachable connection structure.

7. The segmented plug-type left atrial appendage occluder according to any one of claims 1 to 6, characterized in that: During the release process, apart from the anchoring structure, the inner plug structure may form a smooth surface contact with the left atrial appendage.

8. The segmented plug-type left atrial appendage occluder according to claim 7, characterized in that: Both the inner and outer plug structures are metal woven mesh structures or laser-engraved mesh structures. The main body of the inner plug structure is disc-shaped, drum-shaped with smooth edges, or cylindrical. One side of the inner plug structure is drawn inward to the fixing member, and the other side is drawn outward to the first connecting member. The main body of the outer plug structure is drum-shaped or cylindrical with smooth edges. One side of the outer plug structure is drawn in and fixed to the second connecting member. The first connecting member and the second connecting member are mechanically inserted or threaded. The other side of the outer plug structure is drawn in and fixed to the third connecting member, which is used to connect the conveying device.

9. The segmented plug-type left atrial appendage occluder according to claim 8, characterized in that: The first connector and the second connector are connected by threads, and the third connector and the conveying device are connected by threads.

10. The segmented plug-type left atrial appendage occluder according to claim 8, characterized in that: Both the inner and outer plug structures are plug-like structures formed by interlacing filaments that are inclined in two directions. One end of the filaments of the inner plug structure is gathered and tied to the fixing member, and the other end is gathered and tied to the first connecting member, forming a smooth curved surface between the first connecting member and the fixing member. One end of the filaments of the outer plug structure is gathered and tied to the second connecting member, and the other end is gathered and tied to the third connecting member. The porosity of the inner plug structure is greater than that of the outer plug structure.

11. The segmented plug-type left atrial appendage occluder according to claim 1, characterized in that: The anchoring structure is an anchor hook, which is curled towards the outer side of the left atrial appendage. The inner plug structure has one anchor hook, and the outer plug structure has two anchor hooks.

12. A left atrial appendage occlusion system, characterized in that: The device includes the segmented plug-type left atrial appendage occluder as described in any one of claims 1 to 11, and further includes a delivery sheath and a delivery device adapted to the segmented plug-type left atrial appendage occluder.

13. The left atrial appendage occlusion system according to claim 12, characterized in that: The conveying device is a conveying steel cable, which is connected to the outer plug structure by threads.

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