A segmented helical disc type left atrial appendage occluder

Abstract

The application discloses a segmented spiral disc type left atrial appendage occluder, which comprises a spiral disc inner plug structure and an outer plug structure detachably connected with the spiral disc inner plug structure; the spiral disc inner plug structure comprises an anchoring section and a deformation section in the shape of a spiral disc; the top of the anchoring section is higher than the height of the deformation section; and the cross-sectional diameter of the anchoring section is larger than that of the deformation section. The spiral disc-shaped deformation section is arranged to make the inner plug structure hollow, so that the inner plug structure can be deformed to a larger extent, can closely fit the complex profile of the inner wall of the atrial appendage in a narrow atrial appendage, and the stability of the occluder is enhanced; the anchoring section firstly enters the narrow atrial appendage during use, the top end of the anchoring section can be well fitted with the inner wall of the atrial appendage, reliable anchoring of the atrial appendage is realized, a stable support point is provided for unfolding and fixing of the inner plug structure, and the stability and reliability of the entire occluder in a complex blood flow dynamic environment are further improved.

Description

Technical Field

[0001] This invention relates to the field of left atrial appendage occlusion devices, and more particularly to a segmented spiral disc type left atrial appendage occlusion device. Background Technology

[0002] Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, significantly increasing the risk of death, stroke, heart failure, cognitive impairment, and dementia, severely impacting patients' quality of life. The prevalence of AF increases with age, and with the accelerating aging of the population, AF will place a heavy burden on society and the healthcare system. Large-scale epidemiological surveys in my country show that the prevalence of AF in the 35-85 age group was 0.61% in 2003, 0.71% in the 35+ age group from 2012 to 2015, and 1.8% in the 45+ age group from 2014 to 2016. In the 75+ age group, the prevalence was 5.4% in men and 4.9% in women. Based on this 2014-2016 study combined with data from my country's 7th National Population Census in 2020, it is estimated that there are approximately 12 million AF patients in my country.

[0003] Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice, posing a serious threat to human health. Long-term AF alters the hemodynamics of the left atrial appendage, leading to blood stasis and the formation of thrombi. If a thrombus breaks off and travels throughout the body via the bloodstream, it can potentially cause ischemic stroke. Studies show that approximately 90% of thrombi in patients with non-valvular AF originate from the left atrial appendage, and AF-related strokes are often characterized by high rates of disability, mortality, and recurrence, placing a heavy burden on patients' families and society.

[0004] Traditional methods for preventing atrial fibrillation thromboembolism primarily involve anticoagulation therapy. Taking novel anticoagulants (NOACs) or warfarin can effectively reduce the risk of thrombosis. However, anticoagulation therapy has several limitations. Firstly, warfarin and similar drugs have a narrow therapeutic window, requiring frequent monitoring of coagulation parameters, such as the international normalized ratio (INR), and adjustments to the drug dosage based on the monitoring results. This not only causes significant inconvenience for patients but also makes it difficult to consistently maintain the INR within the ideal range in practice due to individual patient differences, dietary factors, and interactions with other medications. Secondly, regardless of the medication used, long-term use of anticoagulants carries a risk of bleeding, such as gastrointestinal bleeding or cerebral hemorrhage, severely impacting patients' quality of life and even endangering their lives. For patients with high bleeding risk, such as those with recent active bleeding or severe liver or kidney dysfunction, anticoagulation therapy is not feasible.

[0005] Left atrial appendage occlusion (LAAO), as an emerging treatment method, offers a new option for preventing thromboembolism in patients with atrial fibrillation. This procedure involves placing an occluder at the opening of the left atrial appendage via an interventional approach, blocking the blood flow between the left atrial appendage and the left atrium, thereby eliminating the risk of stroke caused by thrombus detachment. Plug-type occluders are one of the commonly used types of LAAO devices, offering the advantage of better adapting to the complex anatomical structure of the left atrial appendage and achieving more precise occlusion.

[0006] However, when faced with a confined space in the atrial appendage, conventionally sized and structured plug-type occluders are difficult to fit. If the occluder is too large, it cannot enter the atrial appendage smoothly, and forced pushing may cause the atrial appendage to rupture. If the occluder is too small, it cannot achieve effective fixation and occlusion, and there is a risk of thrombus dislodgement. In a confined space, the deployment and fixation process of the occluder also faces challenges, and there is a high possibility that it may not be fully deployed or not securely fixed, thus failing to achieve effective occlusion. Summary of the Invention

[0007] This invention provides a segmented spiral disc type left atrial appendage occluder to solve the above-mentioned problems.

[0008] To achieve the above objectives, the technical solution of the present invention is as follows:

[0009] A segmented spiral disc type left atrial appendage occluder includes a spiral disc inner plug structure and an outer plug structure detachably connected to the lower side of the spiral disc inner plug structure;

[0010] The spiral disc inner plug structure includes an anchoring section and a spiral disc-shaped deformation section; the anchoring section is located on the upper side of the deformation section, and the top height of the anchoring section is higher than the height of the deformation section;

[0011] The cross-sectional diameter of the anchoring section is larger than that of the deformation section.

[0012] Furthermore, the cross-sectional diameter of the anchoring section ranges from 5 to 7 mm, and the cross-sectional diameter of the deformation section ranges from 3 to 4 mm.

[0013] Furthermore, the top of the anchoring section has an anchoring part, and in its natural state, the top end of the anchoring part is located at the center of the deformable section spiral disk.

[0014] Furthermore, a transition section is provided between the anchoring section and the deformation section, wherein the cross-sectional diameter of the transition section is larger than that of the deformation section and smaller than that of the anchoring section.

[0015] Furthermore, the top outer wall of the anchoring part is a smooth spherical shape.

[0016] Furthermore, the inner wall of the outer plug structure is covered with a flow-blocking membrane.

[0017] Furthermore, both the outer plug structure and the spiral disc inner plug structure are provided with anchor hooks on their outer periphery.

[0018] Furthermore, the bottom of the spiral disc inner plug structure is provided with a threaded joint;

[0019] The top of the outer plug structure is provided with a threaded interface for detachable connection with the threaded joint at the bottom of the spiral disc inner plug structure, and the bottom of the outer plug structure is provided with a threaded connector for connection with a connector.

[0020] Furthermore, both the outer plug structure and the spiral disc inner plug structure are integrally formed using a braiding process.

[0021] The beneficial effects of this invention are:

[0022] This invention discloses a segmented spiral disc-type left atrial appendage occluder. The spiral disc-shaped deformation section creates a hollow interior for the inner plug structure, significantly reducing its overall stiffness and increasing its deformation space. This allows the inner plug structure to deform to a greater extent, maintaining a large deformation even within the confined space of the atrial appendage. It closely conforms to the complex contours of the atrial appendage's inner wall, facilitating its fixation and effectively enhancing the stability of the occluder throughout the occlusion process. The anchoring section is designed to enter the confined space first during use, and its tip fits well against the inner wall, achieving reliable anchoring. This reliable anchoring not only ensures the accurate initial placement of the occluder but also provides a stable support point for the subsequent deployment and fixation of the inner plug structure, further improving the stability and reliability of the entire occluder system under complex cardiac hemodynamic conditions. The outer plug structure works in conjunction with the spiral disc-shaped inner plug structure to effectively occlude the left atrial appendage. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 This is a schematic diagram (front view) of a segmented spiral disc type left atrial appendage occluder disclosed in an embodiment of the present invention;

[0025] Figure 2 This is a schematic diagram of the spiral disc inner plug structure of a segmented spiral disc type left atrial appendage occluder disclosed in an embodiment of the present invention. Figure 1 (Main view);

[0026] Figure 3This is a schematic diagram of the spiral disc inner plug structure of a segmented spiral disc type left atrial appendage occluder disclosed in an embodiment of the present invention. Figure 2 (View from above);

[0027] Figure 4 This is a schematic diagram of the external plug structure of a segmented spiral disc type left atrial appendage occluder disclosed in an embodiment of the present invention. Figure 1 (Main view);

[0028] Figure 5 This is a schematic diagram of the external plug structure of a segmented spiral disc type left atrial appendage occluder disclosed in an embodiment of the present invention. Figure 2 (View from above);

[0029] Figure 6 This is a schematic diagram of the structure of a segmented spiral disc left atrial appendage occluder after it is released into the atrial appendage, as disclosed in an embodiment of the present invention.

[0030] In the picture:

[0031] 1. Spiral disc inner plug structure; 11. Anchoring section; 111. Anchoring part; 12. Deformation section; 13. Transition section; 14. Threaded joint;

[0032] 2. External plug structure;

[0033] 3. Anchor hook;

[0034] 4. Threaded interface;

[0035] 5. Threaded connectors;

[0036] 6. Sheath;

[0037] 7. Conveying steel cables. Detailed Implementation

[0038] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0039] like Figure 1 The image shown is a segmented spiral disc type left atrial appendage occluder provided in this embodiment, including a spiral disc inner plug structure 1 and an outer plug structure 2 detachably connected to the lower side of the spiral disc inner plug structure 1;

[0040] like Figure 2-3As shown, the spiral disc inner plug structure 1 includes an anchoring section 11 and a spiral disc-shaped deformation section 12; the anchoring section 11 is located on the upper side of the deformation section 12, and the top height of the anchoring section 11 is higher than the height of the deformation section 12.

[0041] The cross-sectional diameter of the anchoring section 11 is larger than the cross-sectional diameter of the deformation section 12.

[0042] Compared to the cylindrical inner plug structure, the spiral disc-shaped deformation section in this application makes the inner plug structure hollow, greatly reducing its overall stiffness and increasing its deformation space. This allows the inner plug structure to deform to a greater extent, enabling it to maintain significant deformation even within the narrow atrial appendage. It closely conforms to the complex contours of the atrial appendage's inner wall, facilitating the fixation of the inner plug structure and effectively enhancing the stability of the occluder throughout the occlusion process. The anchoring section is designed to enter the narrow atrial appendage first during use, and its tip fits well against the atrial appendage's inner wall, achieving reliable anchoring. This reliable anchoring not only ensures the accurate initial placement of the occluder but also provides a stable support point for the subsequent deployment and fixation of the inner plug structure, further improving the stability and reliability of the entire occluder system under the complex hemodynamic environment of the heart.

[0043] The atrial appendage entrance is typically relatively wide, gradually narrowing inwards. The anchoring section 11 is designed with a relatively large diameter to better match the wide structure at the entrance. Upon entering the atrial appendage, its larger size allows for initial positioning and stabilization, creating favorable conditions for the subsequent smooth entry and deployment of the deformation section 12. Conversely, designing the deformation section 12 with a relatively small cross-sectional diameter allows for flexible deformation and fit even in the relatively narrow space inside the atrial appendage. These two aspects complement each other, ensuring stable placement and effective occlusion of the occluder within the entire atrial appendage. The outer plug structure, in conjunction with the spiral disc-shaped inner plug structure, effectively occludes the left atrial appendage. A schematic diagram showing the morphology and position of the occluder released within the atrial appendage is shown below. Figure 6 As shown.

[0044] In a specific embodiment, the cross-sectional diameter of the anchoring section 11 ranges from 5 to 7 mm, and the cross-sectional diameter of the deformation section 12 ranges from 3 to 4 mm. Under tension, the spiral disc inner plug structure 1 has a cylindrical structure with a diameter gradually decreasing from top to bottom. From the perspective of anchoring stability, setting the cross-sectional diameter of the anchoring section 11 to 5 to 7 mm allows for a significantly increased contact area with the inner wall of the atrial appendage after the larger diameter anchoring section 11 enters the atrial appendage. This increased contact area significantly enhances the friction between the anchoring section 11 and the inner wall of the atrial appendage, thereby strengthening the anchoring stability and effectively preventing displacement of the occluder under cardiac activity and blood flow impact. Setting the cross-sectional diameter of the deformation section 12 to 3 to 4 mm... The smaller diameter (mm) allows the deformable segment 12 to enter the atrial appendage with less resistance, enabling it to penetrate more flexibly. Furthermore, when facing the narrow and irregular internal structure of the atrial appendage, the deformable segment 12 can fully utilize its large deformation range, effectively deforming within a limited space to tightly conform to the inner wall of the atrial appendage and achieve stable fixation. In this embodiment, the anchoring segment 11 has a cross-sectional diameter of 6mm, the deformable segment 12 has a cross-sectional diameter range of 4mm, and the total length of the spiral disc inner plug structure in its straightened state is 60mm. Figure 4-5 As shown, the outer plug structure is a cylindrical structure with a height of 10mm in a natural, unconstrained state.

[0045] In a specific embodiment, the top of the anchoring section 11 has an anchoring part 111. In its natural state, the top of the anchoring part 111 is located at the center of the spiral disk of the deformable section 12. Since the top of the anchoring part 111 is located at the center of the spiral disk of the deformable section 12, when the deformable section 12 begins to deform and unfold in the narrow atrial appendage during use, it can be evenly stressed with the anchoring part 111 as the center, avoiding tilting or displacement caused by uneven stress on one side. This stable unfolding process allows the inner plug structure to better fit the inner wall of the atrial appendage, further enhancing the fixation effect of the occluder and reducing the risk of the occluder falling off or shifting under the impact of heartbeat and blood flow.

[0046] In a specific embodiment, a transition section 13 is provided between the anchoring section 11 and the deformation section 12. The cross-sectional diameter of the transition section 13 is larger than that of the deformation section 12 but smaller than that of the anchoring section 11. The cross-sectional diameter of the transition section 13 is between that of the anchoring section 11 and the deformation section 12, forming a gradual mechanical structure. When the occluder enters the auricle, the anchoring section 11 first withstands a large impact force and achieves initial fixation. The transition section 13 can uniformly transfer the stress transmitted from the anchoring section 11 to the deformation section 12, avoiding damage or abnormal deformation of the deformation section 12 due to sudden stress changes. From the perspective of structural stability, the setting of the transition section 13 enhances the overall stability. The continuity and stability of the occluder structure, under the complex beating and blood flow impact environment of the heart, the transition section 13 can reduce stress concentration between components of different diameters, prevent the overall displacement or loosening of the occluder due to structural discontinuity, and ensure that the occluder maintains a stable working state during long-term use. Due to the complex internal spatial structure of the atrial appendage, the gradual diameter design of the transition section 13 can better adapt to the geometric changes inside the atrial appendage, reduce the resistance and jamming encountered during advancement. The transition section 13 helps the occluder to advance smoothly when entering the atrial appendage, enabling doctors to place the occluder in the predetermined position more easily and accurately, improving the success rate and efficiency of the surgical operation.

[0047] In a specific embodiment, the outer wall of the anchoring part 111 is a smooth sphere with no protrusions on its surface. Since the tissue deep inside the atrial appendage is thin, the smooth sphere-shaped anchoring part can avoid damage to the atrial appendage when it enters the atrial appendage, greatly improving the safety of operations inside the atrial appendage.

[0048] In a specific embodiment, the inner wall of the outer plug structure 2 is covered with a flow-blocking membrane; the flow-blocking membrane works in conjunction with the outer plug structure 2 to achieve the sealing effect on the opening of the left atrial appendage.

[0049] In a specific embodiment, both the outer plug structure 2 and the spiral disc inner plug structure 1 are provided with anchor hooks 3 on their outer periphery. The ends of the anchor hooks 3 are rounded and blunt, and the anchor hooks 3 are evenly distributed to anchor the atrial appendage pectinate muscle or atrial appendage structure, providing long-term stability for this occluder. The anchor hooks 3 on the outer periphery of the outer plug structure 2 are "J"-shaped barbed structures, with the end away from the plug body being pointed and rounded to effectively prevent damage to the inner wall of the left atrial appendage and pectinate muscle. The anchor hooks 3 on the outer periphery of the spiral disc inner plug structure 1 are... The main body of the structure is also in the shape of a "J"-shaped barb, but its end (terminus) is coiled and curled towards the side close to the plug body, that is, the tip is gathered inward and forms a smooth circular wall. The circular part of the anchor hook is used for anchoring, thereby avoiding damage to the thin inner wall and pectinate muscle deep in the narrow left atrial appendage by its tip, thus improving the safety during operation. At the same time, in order to increase the friction during anchoring, the surface of the anchor hook 3 is roughened to further improve the stability of the occluder in the left atrial appendage and further prevent the occluder from falling off.

[0050] In a specific embodiment, the bottom of the spiral disc inner plug structure 1 is provided with a threaded joint 14;

[0051] The top of the outer plug structure 2 is provided with a threaded interface 4 for detachable connection with the threaded joint at the bottom of the spiral disc inner plug structure 1, and the bottom of the outer plug structure 2 is provided with a threaded connector 5 for connection with the connector. The threaded joint and threaded interface 4 facilitate the connection and disassembly of the two. In actual use, the two can be connected and used in combination or the outer plug structure 2 can be used alone, depending on the condition inside the heart. The threaded connector 5 facilitates the connection between the outer plug structure 2 and the threaded part at the end of the delivery steel cable, which facilitates the delivery of the occluder.

[0052] In a specific embodiment, both the outer plug structure 2 and the spiral disc inner plug structure 1 are integrally formed by a braiding process and are made of nickel-titanium alloy, which gives the inner and outer plugs good elasticity, allows them to be repeatedly recycled and reused without deformation, and is economical and practical.

[0053] The following is a description of the usage process of this double-plug plug:

[0054] The occluder is placed into the delivery sheath 6, and the head of the delivery sheath 6 is placed into the left atrial appendage. Then, the delivery cable 7 is pushed to push the occluder out of the sheath 6 and release it into the left atrial appendage. The anchoring section 11 of the spiral disc inner plug structure first enters the depth of the left atrial appendage and is anchored against the inner wall. Then, the deformation section 12 enters the left atrial appendage and is adaptively deformed and unfolded due to the obstruction of the left atrial appendage to adapt to the internal structure of the left atrial appendage, thereby enhancing the fixation effect of the occluder. Then, the outer plug structure 2 is released and locked at the opening of the left atrial appendage. The anchor hooks 3 on the outer periphery of the inner plug structure 1 and the outer plug structure 2 anchor the left atrial appendage structure. The outer plug structure 2 works with the flow-blocking membrane to block the left atrial appendage, preventing blood from entering the left atrial appendage and achieving the purpose of preventing thromboembolism. Finally, the delivery cable 7 is rotated in the opposite direction to separate it from the threaded connector 5. The delivery cable 7 and the delivery sheath 6 are taken out, completing the delivery, placement, and release of the occluder.

[0055] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A segmented spiral disc type left atrial appendage occlusion device, characterized in that, It includes a spiral disc inner plug structure (1) and an outer plug structure (2) detachably connected to the lower side of the spiral disc inner plug structure (1). The spiral disc inner plug structure (1) includes an anchoring section (11) and a spiral disc-shaped deformation section (12); the anchoring section (11) is located on the upper side of the deformation section (12), and the top height of the anchoring section (11) is higher than the height of the deformation section (12); The cross-sectional diameter of the anchoring section (11) is larger than that of the deformation section (12); the anchoring section (11) can provide support points for the unfolding and fixing of the spiral disc inner plug structure; The spiral disc-shaped deformation section (12) makes the interior of the spiral disc inner plug structure (1) hollow, which increases the deformation space of the spiral disc inner plug structure (1). The top of the anchoring section (11) has an anchoring part (111), and in its natural state, the top of the anchoring part (111) is located at the center of the spiral disk of the deformation section (12). A transition section (13) is provided between the anchoring section (11) and the deformation section (12). The cross-sectional diameter of the transition section (13) is larger than that of the deformation section (12) and smaller than that of the anchoring section (11). The top outer wall of the anchoring part (111) is a smooth sphere; When in use, after the spiral disc inner plug structure (1) enters the left atrial appendage, the spiral disc inner plug structure (1) can deform and unfold inside the left atrial appendage cavity through the anchoring effect of the anchoring section (11) and the deformation space provided by the deformation section (12), thus achieving fixation inside the left atrial appendage cavity. Then the outer plug structure (2) is released and locked at the opening of the left atrial appendage. Finally, the spiral disc inner plug structure (1) and the outer plug structure (2) work together to achieve sealing.

2. The segmented spiral disc type left atrial appendage occlusion device according to claim 1, characterized in that, The diameter of the anchoring section (11) is in the range of 5~7mm, and the diameter of the deformation section (12) is in the range of 3~4mm.

3. A segmented spiral disc type left atrial appendage occlusion device according to claim 1, characterized in that, The inner wall of the outer plug structure (2) is covered with a flow-blocking membrane.

4. A segmented spiral disc type left atrial appendage occlusion device according to claim 1, characterized in that, Anchor hooks (3) are provided on the outer periphery of both the outer plug structure (2) and the spiral disc inner plug structure (1).

5. A segmented spiral disc type left atrial appendage occlusion device according to claim 1, characterized in that, The bottom of the spiral disc inner plug structure (1) is provided with a threaded joint (14). The top of the outer plug structure (2) is provided with a threaded interface (4) for detachable connection with the threaded joint at the bottom of the spiral disc inner plug structure (1), and the bottom of the outer plug structure (2) is provided with a threaded connector (5) for connection with the connector.

6. A segmented spiral disc type left atrial appendage occlusion device according to claim 1, characterized in that, Both the outer plug structure (2) and the spiral disc inner plug structure (1) are integrally formed using a braiding process.

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