Segmented spiral disc type left auricle plugging device

Abstract

The invention discloses a segmented spiral disc type left auricle plugging device 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 spiral disc-shaped deformation section; the top of the anchoring section is higher than the deformation section; the section diameter of the anchoring section is larger than that of the deformation section. The spiral disc-shaped deformation section enables the interior of the inner plug structure to be in a hollow state, so that the inner plug structure can deform to a greater extent, the inner plug structure can still be tightly attached to the complex outline of the inner wall of an auricle in a narrow auricle, and the stability of the plugging device is enhanced; the anchoring section firstly enters the narrow auricle during use, and the top end of the anchoring section can be well attached to the inner wall of the auricle, so that reliable anchoring of the auricle is achieved, a stable supporting point is provided for subsequent unfolding and fixing of an inner plug structure, and the stability and reliability of the whole plugging device in a complex hemodynamic environment are further improved.

Description

Technical Field

[0001] The present invention relates to the technical field of left atrial appendage occluder, and in particular to a segmented spiral disc type left atrial appendage occluder. Background Art

[0002] Atrial fibrillation (AF) is the most common clinical arrhythmia, significantly increasing the risk of death, stroke, heart failure (HF), cognitive impairment and dementia, and seriously affecting the quality of life of patients. The prevalence of AF increases with age. As the aging process of the population accelerates, AF will bring a heavy burden to the society and medical service system. A large-scale epidemiological survey in my country showed that the prevalence of AF in people aged 35-85 was 0.61% in 2003, 0.71% in people aged 35 and above in 2012-2015, 1.8% in people aged 45 and above in 2014-2016, and 5.4% and 4.9% in men and women in people aged 75 and above, respectively. According to this study from 2014 to 2016 combined with the data of the 7th National Population Census in my country in 2020, it is estimated that there are about 12 million patients with AF in my country.

[0003] Atrial fibrillation (AF) is one of the most common arrhythmias clinically and poses a serious threat to human health. Long-term AF can change the hemodynamics in the left atrial appendage of the heart, leading to blood stasis and the formation of blood clots. Once a blood clot breaks off and flows throughout the body with the blood circulation, it is very likely to cause an ischemic stroke. Studies have shown that among patients with non-valvular AF, about 90% of the blood clots originate from the left atrial appendage, and AF-related strokes are often characterized by high disability, high mortality, and high recurrence rates, which imposes a heavy burden on patients' families and society.

[0004] The traditional method of preventing thromboembolism in atrial fibrillation is mainly drug anticoagulation therapy. Taking anticoagulants such as novel anticoagulants (NOAC) / warfarin can effectively reduce the risk of thrombosis. However, anticoagulant therapy has many limitations. On the one hand, the therapeutic window of drugs such as warfarin is narrow, and coagulation indicators such as the international normalized ratio (INR) need to be frequently monitored, and the drug dosage should be adjusted according to the monitoring results. This not only brings great inconvenience to patients. At the same time, in actual operation, due to individual differences in patients, diet and other drug interactions, it is difficult to stably control the INR value within the ideal range. On the other hand, no matter what kind of drug is taken, long-term use of anticoagulants has the risk of bleeding, such as gastrointestinal bleeding, cerebral hemorrhage, etc., which seriously affects the quality of life of patients and even endangers their lives. For some patients with high risk of bleeding, such as recent active bleeding, severe liver and kidney dysfunction, etc., anticoagulant therapy cannot be implemented.

[0005] As an emerging treatment method, left atrial appendage occlusion provides a new option for patients with atrial fibrillation to prevent thromboembolism. This surgery places an occluder at the opening of the left atrial appendage through interventional means to block the blood flow channel between the left atrial appendage and the left atrium, thereby eliminating the risk of thrombus detachment and causing stroke from the source. The plug occluder is one of the commonly used types of left atrial appendage occluders, which has the advantage of being able to better adapt to the complex anatomical morphology of the left atrial appendage and achieve more precise occlusion.

[0006] However, when the space in the atrial appendage is small, the current plug-type occluders of conventional size and structure are difficult to adapt. If the occluder is too large, it cannot enter the atrial appendage smoothly, and forced pushing may also cause the atrial appendage to rupture. If the occluder is too small, it cannot be effectively fixed and blocked, and there is a risk of thrombus detachment. In the narrow space, the deployment and fixation process of the occluder also faces challenges, and it is very likely that the deployment will be incomplete or the fixation will be loose, and effective blocking cannot be achieved. Summary of the invention

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

[0008] In order to achieve the above object, the technical solution of the present invention is:

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

[0010] The spiral disk plug structure includes an anchoring section and a spiral disk-shaped deformation section; the anchoring section is arranged 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 greater than the cross-sectional diameter 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 portion, and in a natural state, the top end of the anchoring portion is arranged at the center of the spiral disk of the deformation section.

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

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

[0016] Furthermore, the inner walls of the outer plug structure are covered with a flow-blocking film.

[0017] Furthermore, anchor hooks are provided on the outer circumferences of the outer plug structure and the spiral disk inner plug structure.

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

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

[0020] Furthermore, the outer plug structure and the spiral disk inner plug structure are both integrally formed by a weaving process.

[0021] The beneficial effects of the present invention are:

[0022] The present invention discloses a segmented spiral disc type left atrial appendage occluder. The spiral disc-shaped deformation section makes the interior of the inner plug structure hollow, greatly reduces the overall rigidity of the inner plug structure, and is beneficial to increase the deformation space of the inner plug structure. The inner plug structure can produce a greater degree of deformation, so that it can still have a large deformation in the narrow atrial appendage, closely fit the complex contour of the inner wall of the atrial appendage, facilitate the fixation of the inner plug structure, and effectively enhance the stability of the occluder in the whole occlusion process; the anchoring section can first enter the narrow atrial appendage when in use, and its top end can fit well with the inner wall of the atrial appendage to achieve reliable anchoring of the atrial appendage. This reliable anchoring not only ensures the accurate position of the occluder during initial placement, 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 in the complex hemodynamic environment of the heart; the outer plug structure cooperates with the spiral disc-shaped inner plug structure to achieve effective occlusion of the left atrial appendage. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0024] Figure 1 It is a structural 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 Schematic diagram of the spiral disk inner plug structure of a segmented spiral disk left atrial appendage occluder disclosed in an embodiment of the present invention Figure 1 (main view);

[0026] Figure 3Schematic diagram of the spiral disk inner plug structure of a segmented spiral disk left atrial appendage occluder disclosed in an embodiment of the present invention Figure 2 (looking down);

[0027] Figure 4 Schematic diagram of the outer plug structure of a segmented spiral disc left atrial appendage occluder disclosed in an embodiment of the present invention Figure 1 (main view);

[0028] Figure 5 Schematic diagram of the outer plug structure of a segmented spiral disc left atrial appendage occluder disclosed in an embodiment of the present invention Figure 2 (looking down);

[0029] Figure 6 It is a schematic structural diagram of a segmented spiral disc type left atrial appendage occluder disclosed in an embodiment of the present invention after being released in the atrial appendage.

[0030] In the figure:

[0031] 1. Spiral disk plug structure; 11. Anchoring section; 111. Anchoring portion; 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 cable. DETAILED DESCRIPTION

[0038] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0039] like Figure 1 The figure shows a segmented spiral disk type left atrial appendage occluder provided in this embodiment, comprising a spiral disk inner plug structure 1 and an outer plug structure 2 detachably connected to the lower side of the spiral disk inner plug structure 1;

[0040] like Figure 2-3As shown, the spiral disk plug structure 1 includes an anchoring section 11 and a spiral disk-shaped deformation section 12; the anchoring section 11 is arranged 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 greater than the cross-sectional diameter of the deformation section 12 .

[0042] Compared with the columnar inner plug structure, the spiral disk-shaped deformation section provided in the present application makes the inner plug structure hollow inside, greatly reducing the overall rigidity of the inner plug structure, which is beneficial to increase the deformation space of the inner plug structure. The inner plug structure can produce a greater degree of deformation, so that it can still have a large deformation in the narrow atrial appendage, closely fit the complex contour of the inner wall of the atrial appendage, facilitate the fixation of the inner plug structure, and effectively enhance the stability of the occluder during the entire occlusion process; the provided anchoring section can first enter the narrow atrial appendage when in use, and its top end can fit well with the inner wall of the atrial appendage to achieve reliable anchoring of the atrial appendage. This reliable anchoring not only ensures the accurate position of the occluder during initial placement, 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 in the complex hemodynamic environment of the heart;

[0043] The entrance of the atrial appendage is usually relatively wide, and the inside gradually narrows. The anchoring section 11 is set to a relatively large diameter so that it can better match the wide structure of the entrance of the atrial appendage. When entering the atrial appendage, it can first achieve preliminary positioning and stability by virtue of its own large size, creating favorable conditions for the smooth entry and deployment of the subsequent deformation section 12. The cross-sectional diameter of the deformation section 12 is designed to be relatively small, so that when entering the relatively narrow space inside the atrial appendage, it can still be flexibly deformed and fitted. The two complement each other to ensure the stable placement and effective occlusion of the occluder in the entire atrial appendage; the outer plug structure cooperates with the spiral disc-shaped inner plug structure to achieve effective occlusion of the left atrial appendage. The shape and position diagram of the occluder released in the atrial appendage is shown in the figure Figure 6 shown.

[0044] In a specific embodiment, the cross-sectional diameter of the anchoring segment 11 is in the range of 5 to 7 mm, and the cross-sectional diameter of the deformation segment 12 is in the range of 3 to 4 mm. In the stretched state, the spiral disk plug structure 1 is a cylindrical structure with a diameter that gradually decreases from top to bottom. From the perspective of anchoring stability, the cross-sectional diameter of the anchoring segment 11 is set to 5 to 7 mm. After the anchoring segment 11 with a larger diameter enters the auricle, the contact area with the inner wall of the auricle is significantly increased. The increased contact area greatly increases the friction between the anchoring segment 11 and the inner wall of the auricle, thereby enhancing the stability of the anchoring and effectively preventing the occluder from shifting under the impact of the heart beating and blood flow; the cross-sectional diameter of the deformation segment 12 is set to 3 to 4 mm, the smaller diameter makes the deformation section 12 less obstructed when entering the auricle, and can be more flexible and deep. At the same time, when facing the narrow and irregular internal structure of the auricle, the deformation section 12 can give full play to its large deformation amplitude, effectively deform in a limited space, closely fit the inner wall of the auricle, and achieve stable fixation; in this embodiment, the cross-sectional diameter of the anchoring section 11 is set to 6mm, the cross-sectional diameter range of the deformation section 12 is 4mm, and the total length of the spiral disk plug structure in the straight state is 60mm; Figure 4-5 As shown, the outer plug structure is a cylindrical structure, and the height is 10 mm in a natural unconstrained state.

[0045] In a specific embodiment, the top of the anchoring segment 11 has an anchoring portion 111, and in a natural state, the top of the anchoring portion 111 is arranged at the center of the spiral disk of the deformation segment 12; since the top of the anchoring portion 111 is located at the center of the spiral disk of the deformation segment 12, when the deformation segment 12 begins to deform and expand in the narrow auricle during use, it can be uniformly stressed with the anchoring portion 111 as the center, avoiding tilting or displacement caused by uneven force on one side. This stable expansion process enables the inner plug structure to better fit the inner wall of the auricle, further enhancing the fixing effect of the occluder, and reducing the risk of the occluder falling off or shifting under the impact of heart beating 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 the cross-sectional diameter of the deformation section 12 and smaller than the cross-sectional diameter of the anchoring section 11. The cross-sectional diameter of the transition section 13 is between the anchoring section 11 and the deformation section 12, forming a gradual mechanical structure. When the occluder enters the atrial appendage, the anchoring section 11 first bears a large impact force and achieves preliminary fixation. The transition section 13 can evenly transition the stress transmitted from the anchoring section 11 to the deformation section 12, thereby avoiding damage or abnormal deformation of the deformation section 12 due to sudden stress changes. From the perspective of structural stability, the provision of the transition section 13 enhances the stability of the entire In order to improve the consistency and stability of the occluder structure, under the complex beating of the heart and the impact of blood flow, the transition section 13 can reduce the 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 space structure of the atrial appendage, the gradual diameter design of the transition section 13 can better adapt to the changes in the geometric shape inside the atrial appendage, reduce the resistance and jamming encountered during the advancement process, and the transition section 13 helps the smooth advancement of the occluder when entering the atrial appendage, so that the doctor can place the occluder at the predetermined position more easily and accurately, thereby improving the success rate and efficiency of the surgical operation.

[0047] In a specific embodiment, the outer wall of the anchoring portion 111 is smooth and spherical, and there is no protrusion on its surface. Since the tissue deep in the auricle is thinner, when the anchoring portion enters deep into the auricle, the smooth and spherical anchoring portion can avoid causing damage and destruction to the auricle, thereby greatly improving the safety of operations in the auricle.

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

[0049] In a specific embodiment, the outer circumference of the outer plug structure 2 and the spiral disk inner plug structure 1 are both provided with anchor hooks 3, and the ends of the anchor hooks 3 are rounded and blunt, and the anchor hooks 3 are evenly arranged to anchor the atrial appendage pectinate muscle or atrial appendage structure to provide long-term stability for the occluder; the anchor hooks 3 on the outer circumference of the outer plug structure 2 are "J"-shaped barbed hook structures, and the end away from the plug body is a pointed end, and it is set to a rounded and blunt shape, the purpose is to effectively prevent damage to the inner wall of the left atrial appendage and the pectinate muscle, the anchor hooks 3 on the circumference of the spiral disk inner plug structure 1 are rounded and blunt, and the ends of the anchor hooks 3 on the outer ... The main body of the anchor hook is also in a "J"-shaped hook shape, but its end (terminal end) is coiled toward the side close to the plug body, that is, the tip is gathered inward to form a smooth round wall, and the round segment of the anchor hook is used for anchoring, thereby avoiding the tip of the end from damaging the thinner inner wall and pectinate muscle deep in the narrow left atrial appendage, thereby 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, a threaded joint 14 is provided at the bottom of the spiral disk plug structure 1;

[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 disk inner plug structure 1, and the bottom of the outer plug structure 2 is provided with a threaded connector 5 for connection with a connector; the setting of the threaded joint and the threaded interface 4 facilitates the connection and disassembly of the two. In actual use, the two can be selected for combined use or the outer plug structure 2 can be used alone according to the situation in the auricle; the setting of the threaded connector 5 facilitates the connection of the outer plug structure 2 with the threaded part at the end of the delivery cable, which facilitates the delivery of the occluder.

[0052] In a specific embodiment, the outer plug structure 2 and the spiral disk inner plug structure 1 are both integrally formed by a weaving process and are made of nickel-titanium alloy, so that the inner plug and the outer plug have good elasticity, can be recycled and reused repeatedly without deformation, and are economical and applicable.

[0053] The following is a description of the use of the double-plug occluder:

[0054] The occluder is placed in the delivery sheath 6 and then the head of the delivery sheath 6 is placed in the left atrial appendage, and 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 disk inner plug structure first enters the deep part of the left atrial appendage and is anchored in contact with the inner wall, and then the deformation section 12 enters the left atrial appendage and is obstructed by the left atrial appendage and adaptively deforms and unfolds to adapt to the internal structure of the left atrial appendage, thereby enhancing the fixing effect of the occluder. Then the outer plug structure 2 is released and stuck in the mouth of the left atrial appendage, and 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, and the outer plug structure 2 cooperates with the flow-blocking membrane to achieve the occlusion of the left atrial appendage to prevent blood from entering the left atrial appendage, thereby 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, and the delivery cable 7 and the delivery sheath 6 are taken out to complete 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, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements 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 left atrial appendage occluder, characterized in that: It comprises a spiral disk inner plug structure (1) and an outer plug structure (2) detachably connected to the lower side of the spiral disk inner plug structure (1); The spiral disk plug structure (1) comprises an anchoring section (11) and a spiral disk-shaped deformation section (12); the anchoring section (11) is arranged 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 greater than the cross-sectional diameter of the deformation section (12).

2. A segmented spiral disc left atrial appendage occluder according to claim 1, characterized in that: 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.

3. The segmented spiral disc left atrial appendage occluder according to claim 1, characterized in that: The top of the anchoring section (11) is provided with an anchoring portion (111). In a natural state, the top end of the anchoring portion (111) is arranged at the center of the spiral disk of the deformation section (12).

4. The segmented spiral disc left atrial appendage occluder according to claim 1, characterized in that: 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 the cross-sectional diameter of the deformation section (12) and smaller than the cross-sectional diameter of the anchoring section (11).

5. The segmented spiral disc left atrial appendage occluder according to claim 3, characterized in that: The top outer wall of the anchoring portion (111) is in the shape of a smooth sphere.

6. The segmented spiral disc left atrial appendage occluder according to claim 1, characterized in that: The inner wall of the outer plug structure (2) is covered with a flow-blocking film.

7. The segmented spiral disc left atrial appendage occluder according to claim 1, characterized in that: Anchor hooks (3) are provided on the outer circumferences of the outer plug structure (2) and the spiral disk inner plug structure (1).

8. The segmented spiral disc left atrial appendage occluder according to claim 1, characterized in that: A threaded joint (14) is provided at the bottom of the spiral disk inner plug structure (1); The top of the outer plug structure (2) is provided with a threaded interface (4) for detachably connecting with the threaded joint at the bottom of the spiral disk inner plug structure (1), and the bottom of the outer plug structure (2) is provided with a threaded connector (5) for connecting with a connector.

9. The segmented spiral disc left atrial appendage occluder according to claim 1, characterized in that: The outer plug structure (2) and the spiral disk inner plug structure (1) are both integrally formed by a weaving process.

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