Left atrial appendage occluder and left atrial appendage occluder operating device

Abstract

The invention provides a left atrial appendage occluder and a left atrial appendage occluder operating device, the left atrial appendage occluder comprises an occluder main body, the occluder main body is made of a foam material, and the occluder main body is internally provided with biological mucilage glue so as to be filled in a pore channel of the occluder main body. As the plugging main body is made of foam, the plugging main body is provided with a plurality of pore channels. Under normal conditions, the plugging body is filled with the biological mucilage glue and then plugged into the sheathing canal, and the plugging body is driven by the sheathing canal to enter a specific area of the body of a patient. The plugging main body placed in a specific area can expand when encountering blood and being placed in an area where expansion of the plugging main body is not limited any more, so that the biological mucilage glue can be diffused outwards to the outside of the plugging main body. And after a period of time, the biological mucilage glue is coagulated, so that the plugging main body is coagulated in a predetermined area of the patient to realize plugging.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a left atrial appendage occluder and a left atrial appendage occluder operating device. Background Technology

[0002] Atrial fibrillation (AF) is a common arrhythmia in elderly patients, and the number of patients is expected to continue to increase with the aging population. AF can lead to stroke, which can cause disability or even death in severe cases. Anticoagulation therapy is a traditional method for stroke prevention, but it presents certain challenges in practice, including the risk of bleeding during treatment and patient refusal / non-compliance / intolerance to long-term anticoagulation therapy.

[0003] Studies have found that the vast majority of strokes are related to blood clots originating in the left atrial appendage (LAA). If the LAA can be isolated from the circulatory system, blood clots in the LAA can be prevented from entering the heart, thus avoiding thrombotic complications caused by atrial fibrillation. A LAA occluder can be inserted into the heart via catheter to block or cover the pathway between the LAA and the atria, isolating blood flow between them and fundamentally resolving the blood clot problem. Currently, this method is widely accepted and used as an effective treatment for non-valvular atrial fibrillation.

[0004] Most existing left atrial appendage occluders on the market have skeletons made of nickel-titanium alloy. While they offer good occlusion, the non-degradable nickel-titanium alloy remains permanently inside the body, posing risks such as metal ion leakage. Degradable occluders, as an alternative, can effectively solve this problem. However, degradable materials have poorer shape recovery than metals, and cannot fully return to their designed shape after release, potentially leading to residual problems during the occlusion process. Summary of the Invention

[0005] In order to overcome at least one of the defects described in the prior art, the purpose of this application is to provide a left atrial appendage occluder and a left atrial appendage occluder operating device to solve the problems of existing left atrial appendage occluders.

[0006] In a first aspect, this application provides a left atrial appendage occlusion device, including an occlusion body made of foam material, and the occlusion body having a bio-adhesive to fill the pores of the occlusion body.

[0007] In some embodiments of this application, a cover is also included, which can cooperate with the sealing body to restrict the position of the sealing body.

[0008] In some embodiments of this application, the volume of the occlusion body is more than 150% of the volume of the left atrial appendage.

[0009] In some embodiments of this application, the channels of the sealing body are interconnected.

[0010] In some embodiments of this application, the average diameter of each of the channels located at the center of the sealing body is small, while the average diameter of each of the channels located around the periphery of the sealing body is large.

[0011] In some embodiments of this application, the sealing body is polyurethane, polycaprolactone, polylactide, polytrimethylene carbonate, polydodecaneglycerol, or poly(ω-pentadecanolactone).

[0012] In some embodiments of this application, the compressed sealing body can expand and recover.

[0013] In some embodiments of this application, the bio-adhesive includes one or more of fibrin glue, polydopamine-type polyurethane adhesive, amino-containing polyester polyurethane, poly(N-isopropylacrylamide), and cyanoacrylate, and the bio-adhesive is in liquid state.

[0014] In some embodiments of this application, the bio-adhesive is a powder.

[0015] In some embodiments of this application, multiple sealing bodies are included, which are connected by connecting lines. The bio-adhesive is trilysine powder and polyethylene glycol powder, and the trilysine powder and the polyethylene glycol powder are placed in different sealing bodies.

[0016] In some embodiments of this application, a connecting line and a plurality of sealing bodies are included. The connecting line is sequentially inserted through the plurality of sealing bodies, and the plurality of sealing bodies are slidable on the connecting line. The connecting line is elastic and is made of poly(p-dioxanone).

[0017] In some embodiments of this application, the cover is provided with a through hole for the sealing body to pass through.

[0018] In some embodiments of this application, the through hole is located at the geometric center of the cover, and the through hole has a threaded structure.

[0019] Secondly, this application provides a left atrial appendage occlusion device, including a catheter, a first push rod, a second push rod, and a left atrial appendage occlusion device as provided in the first aspect. One end of the first push rod is connected to the cover, and the first push rod is movably disposed in the catheter to push the cover out of the catheter or retract it into the catheter. The first push rod is hollow and is used to house the sealing body. The second push rod is movably disposed inside the first push rod and is used to push the sealing body out of the first push rod.

[0020] In some embodiments of this application, the cover is provided with a through hole for the sealing body to pass through, the through hole is connected to the inner cavity of the first push rod, and the sealing body is pushed out of the first push rod through the through hole.

[0021] In some embodiments of this application, the through hole is located at the geometric center of the cover, the through hole has a threaded structure, and the cover is threadedly connected to the first push rod.

[0022] In some embodiments of this application, the plurality of occlusion bodies of the left atrial appendage occluder are arranged sequentially along the axial direction of the first push rod in the first push rod.

[0023] In one embodiment of this disclosure, the sealing body is made of foam and contains bio-adhesive to fill the pores within it. In this scheme, the adhesive inside the sealing body expands and gradually diffuses to the surrounding foam, adhering to the tissue inside the left atrial appendage, thereby achieving complete filling and sealing of the left atrial appendage. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the compressed structure of the sealing body in one embodiment of this disclosure; Figure 2 This is a schematic diagram of the structure of the sealing body after expansion in one embodiment of this disclosure; Figure 3 This is a structural schematic diagram of the cover in a certain state according to a certain embodiment of the present disclosure; Figure 4 for Figure 3 A schematic diagram of the unfolded structure of the cover. Figure 5 This is a schematic diagram of the structure of the left atrial appendage occluder entering the left atrial appendage according to the present disclosure; Figure 6 This is a schematic diagram of the structure of the occlusion body at the left atrial appendage after expansion. Figure 7 This is a schematic diagram of another type of cover structure disclosed herein; Figure 8 From another angle Figure 7 A schematic diagram of the structure of the cover; Figure 9 This is a schematic diagram of the structure of a left atrial appendage occluder in another embodiment of the present disclosure; Figure 10This is a schematic diagram of the structure of the left atrial appendage occluder in another embodiment of the present disclosure; Figure 11 This is a cross-sectional view of the interior of the sealing body disclosed herein; Figure 12 This is a schematic diagram of the structure of the cover after it is unfolded in another embodiment of this disclosure; Figure 13 This is a schematic diagram of the operating device of the left atrial appendage occluder in one embodiment of the present disclosure; Figure 14 This is a schematic diagram of the structure in one embodiment of the present disclosure, showing the cover being pushed out of the conduit; Figure 15 for Figure 14 A magnified view of a portion of the image; Figure 16 This is a schematic diagram of the structure in one embodiment of the present disclosure, showing the blocking body being pushed out of the first push rod; Figure 17 This is a schematic diagram of the structure in one embodiment of the present disclosure where the cover is retracted into the conduit; Figure 18 This is a schematic cross-sectional view of the first push rod in another embodiment of this disclosure; Figure 19 This is a flowchart illustrating the operation of a left atrial appendage occlusion method in one embodiment of this disclosure.

[0025] The diagram shows the following markings: 100, occlusion body; 110, channel; 200, cover; 210, support; 220, through hole; 221, threaded structure; 300, connecting line; 400, sheath; 1000, left atrial appendage occlusion device; 500, catheter; 600, first push rod; 610, inner cavity; 620, branch channel; 700, second push rod. Detailed Implementation

[0026] To better understand and implement this application, the technical solutions in this application will be clearly and completely described below with reference to the accompanying drawings.

[0027] In the description of this application, it should be noted that the terms "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "far", "near", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0028] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the specification of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application.

[0029] The first aspect of this disclosure provides a left atrial appendage occlusion device, including an occlusion body 100, the occlusion body 100 being made of foam material, and the occlusion body 100 having a bio-adhesive to fill the channels 110 of the occlusion body 100.

[0030] Since the sealing body 100 is made of foam material, it has several channels 110.

[0031] It should be noted that, under normal circumstances, for liquid bio-adhesive, the occlusion body 100 is first filled with bio-adhesive before being inserted into the sheath 400. The sheath 400 then guides the occlusion body 100 into a specific area of ​​the patient's body. When the sheath 400 is inserted, the compression of the occlusion body 100 may cause some bio-adhesive to be squeezed out. However, due to the restrictive effect of the sheath 400, most of the bio-adhesive is retained within the sheath 400. Simultaneously, because the occlusion body 100 is a foam that shrinks within the sheath 400, the internal channels 110 of the occlusion body 100 are blocked or their diameters become very narrow, thus affecting the flow of bio-adhesive within the occlusion body 100 and preventing its leakage. The bio-adhesive, before solidifying, remains liquid, allowing it to flow and diffuse within and out of the occlusion body 100. After a period of time, the bio-adhesive will solidify, thereby solidifying the sealing body 100 in the patient's predetermined area to achieve sealing.

[0032] In some embodiments, the left atrial appendage occlusion device further includes a cap 200, which cooperates with the occlusion body 100 to restrict the position of the occlusion body 100. The cap 200 is a metal cap 200, which can be prepared by cutting / weaving and can be fixed to the atrial appendage orifice of the left atrial appendage, ensuring that the foam does not fall off inside the left atrial appendage before the bio-adhesive completes the adhesion of the foam. Specifically, the cap 200 can be delivered to the atrial appendage orifice of the left atrial appendage through another sheath 400, and then the occlusion body 100 is delivered into the left atrial appendage through the sheath 400 containing the occlusion body 100. Then, after being removed from the sheath, the pore size of the occlusion body 100 can change from a compressed state to an expanded state, allowing the occlusion body 100, as a compressible foam with shape memory, to expand upon contact with blood, causing the channels 110 inside the occlusion body 100 to recover, thereby connecting the channels 110 inside the occlusion body 100. Therefore, the bio-adhesive can gradually diffuse to the outside of the occlusion body 100 through the restored pores 110. After the foam has completely filled and adhered to the inside of the left atrial appendage, the metal closure cap is removed from the body through the sheath 400.

[0033] It should be noted that the cover 200 includes multiple interconnected support portions 210. Each support portion 210 can retract into the sheath 400 and unfold after detaching from the sheath 400, abutting against the atrial orifice of the left atrial appendage. The cover 200 possesses shape memory properties and can be made of shape memory metal. It can retract into the sheath 400 and, after detaching from the sheath 400, return to its unfolded state due to its shape memory properties.

[0034] In some embodiments, such as Figure 12 As shown, the cover 200 has a through hole 220 for the sealing body 100 to pass through. The sealing body 100 can be pushed out of the cover 200 through the through hole 220. For example, when placing the sealing body 100 into the left atrial appendage, the cover 200 is first conveyed to the atrial opening of the left atrial appendage and acts as a barrier to prevent the sealing body 100 from falling out of the left atrial appendage before it expands; then the sealing body 100 is pushed out and leaves the cover 200 through the through hole 220, and the sealing body 100 is placed inside the left atrial appendage. This arrangement allows the sealing body 100 to be inserted into the left atrial appendage without affecting the blocking effect of the cover 200, and simplifies the operation of inserting the sealing body 100.

[0035] In some embodiments, the through hole 220 is located at the geometric center of the cover 200, and the through hole 220 has a threaded structure 221. This allows for a more uniform structural density distribution of the cover 200. For example, when the cover 200 is formed using a weaving method, the through hole 220 located at the geometric center allows for more uniform stress distribution on the structure of the cover 200, improving the reliability of the cover 200 during use. Exemplarily, multiple support portions 210 are radially distributed, and the through hole 220 may be located at the intersection of the multiple support portions 210. In some examples, the unfolded projection of the cover 200 is circular, and the through hole 220 is located at the center of the circle.

[0036] In some embodiments, the volume of the occlusion body 100 is more than 150% of the volume of the left atrial appendage. It should be noted that the above refers to the volume of the occlusion body 100 before compression being more than 150% of the volume of the left atrial appendage.

[0037] It should be noted that the channels 110 of the sealing body 100 are interconnected. It has a large specific surface area and can adsorb a large amount of bioadhesive. More specifically, during the preparation of the sealing body, some alkaline pore-forming agents can be added to open up the individual channels.

[0038] like Figure 11 As shown, the average pore size of each channel 110 located at the center of the sealing body 100 is small, while the average pore size of each channel 110 located at the periphery of the sealing body 100 is large. It should be noted that the pore size distribution of the sealing body 100 ranges from 100 to 3000 micrometers; the pore size of the channels at the center of the foam is small, while the pore size of the channels at the periphery of the foam is large. The large pore size accelerates water diffusion, ensuring that the bio-adhesive diffuses into the auricle before solidification, thus exerting its adhesive effect. By adjusting the pore size and pore size distribution, the diffusion rate of the bio-adhesive is controlled, ensuring that the expansion time of the foam matches the diffusion and solidification time of the bio-adhesive.

[0039] The sealing material can be compressible foam, such as polyurethane, polycaprolactone, polylactide, polytrimethylene carbonate, polydodecaneglycerol, or poly(ω-pentadecanolactone).

[0040] The compressed sealing body 100 can expand when it comes into contact with blood.

[0041] Bioadhesives include one or more of the following: fibrin glue, polydopamine-type polyurethane adhesive, amino-containing polyester polyurethane, poly(N-isopropylacrylamide), and cyanoacrylate.

[0042] The aperture of the channel 110 of the sealing body 100 is 100~3000 micrometers.

[0043] In some embodiments, the left atrial appendage occlusion device includes multiple occlusion bodies 100, which are connected by connecting lines 300. Furthermore, the bio-adhesive is trilysine powder and polyethylene glycol powder, and the trilysine powder and polyethylene glycol powder are placed in different occlusion bodies. Specifically, the bio-adhesive material is trilysine powder and polyethylene glycol powder, which can be applied to the pores of the occlusion body by spraying. After entering the human body, they fuse upon contact with blood to form a bio-adhesive, ensuring adhesion. It should be noted that the solution disclosed uses powdered trilysine powder and polyethylene glycol powder, and since neither powder itself has adhesive properties, they need to be dissolved in a liquid and mixed to form an adhesive. Therefore, the above solution can avoid the problem of needing multiple adjustments to achieve a left atrial appendage occlusion device that has not solidified after being inserted into the body for a period of time, until the occlusion body of the left atrial appendage occlusion device expands to a predetermined position before solidifying. More specifically, since the trilysine powder and polyethylene glycol powder are placed in different occlusion bodies 100. Once the occluder 100 enters the sheath 400, it is compressed, causing the orifices 110 within the occluder 100 to be blocked or nearly closed. This makes it difficult for blood to enter the occluder 100 to mix with the trilysine powder and polyethylene glycol powder located in different occluder 100s to form a biological adhesive. Only after the left atrial appendage occluder is pushed out of the sheath 400 can the occluder gradually return to its original shape. At this point, the orifices 110 of the occluder 100 are opened, allowing blood to enter and mix with the trilysine powder and polyethylene glycol powder to form a biological adhesive. Before coagulation, this adhesive can leave the left atrial appendage occluder with the blood and enter the left atrial appendage.

[0044] In some embodiments, the sealing body 100 and the connecting line 300 can be biodegradable structures.

[0045] Specifically, the left atrial appendage occlusion device may include multiple small occlusion bodies 100, which are used to occlude the left atrial appendage and other locations. It should be noted that if the occlusion body 100 is too large (even if the left atrial appendage occlusion device is compressible, there is a limit to its compressible volume), the corresponding sheath 400 will also have a larger cross-section, which is not conducive to delivery. However, this solution essentially transforms the occluder into multiple small occlusion bodies 100 connected in series, making it easier to select a sheath 400 with a smaller cross-section and a longer length for delivery. In some embodiments, the connecting wire 300 is made of a biodegradable material.

[0046] In some embodiments, the connecting wire 300 is a highly elastic polymer material, such as polydioxanone. During the expansion of the occlusion body 100, the relative positions between the multiple occlusion bodies 100 change. Therefore, the elastic connecting wire 300 can adapt to the expansion changes of the multiple occlusion bodies 100. For example, the connecting wire 300 can be stretched or compressed to avoid constraining the expansion changes of the multiple occlusion bodies 100 and to ensure that the occlusion body 100 can better fit and occlude the left atrial appendage after expansion.

[0047] In some embodiments, the connecting wire 300 is sequentially threaded through a plurality of occlusion bodies 100, and the occlusion bodies 100 are slidable on the connecting wire 300. During the expansion process after the plurality of occlusion bodies 100 enter the left atrial appendage, since the occlusion bodies 100 and the connecting wire 300 can slide relative to each other, the connecting wire 300 can avoid entanglement or constraint on the occlusion bodies 100, allowing the occlusion bodies 100 to expand freely to better conform to the left atrial appendage.

[0048] In other alternative embodiments, the connecting line 300 and the sealing body 100 may also be connected by adhesive.

[0049] The disclosed left atrial appendage occlusion device, when the occlusion body 100 is in an expanded state, allows for the application of an adhesive bio-adhesive within the foam pores via spraying / impregnation methods. After the occlusion body 100 is delivered to a specific area, it detaches from the sheath 400 and expands. As the occlusion body 100 expands, the bio-adhesive gradually diffuses around it and adheres to the tissues within the left atrial appendage. This allows for better installation of the occlusion body 100 within the left atrial appendage, and also fills any gaps in the occlusion body 100, achieving complete occlusion of the left atrial appendage.

[0050] The sealing body 100 can be cut into various shapes, including cylinders and cubes. A more preferred design is a variety of irregular polyhedral structures, which can effectively increase the friction between the individual foams and ensure the stability of the sealing.

[0051] Secondly, please refer to Figures 13 to 15This disclosure provides a left atrial appendage occlusion device operating device 1000 (hereinafter referred to as operating device 1000), which is used to place the occlusion body 100 of the left atrial appendage occlusion device into a predetermined area. The operating device 1000 includes a catheter 500, a first push rod 600, a second push rod 700, and the left atrial appendage occlusion device provided in any embodiment of the first aspect of this disclosure. One end of the first push rod 600 is connected to the cover 200, and the first push rod 600 is movably disposed within the catheter 500 to push the cover 200 out of the catheter 500 or retract it into the catheter 500; the first push rod 600 is hollow and is used to house the occlusion body 100; the second push rod 700 is movably disposed within the first push rod 600 and is used to push the occlusion body 100 out of the first push rod 600.

[0052] The hollow design of the first push rod 600 allows for the accommodation of the second push rod 700 and the sealing body 100. The inner wall of the first push rod 600 constrains the sealing body 100, preventing it from contacting the outside and keeping it compressed before being pushed out. The second push rod 700 can push the sealing body 100 out of the first push rod 600. The conduit 500 is sleeved around the outer periphery of the first push rod 600, constraining the cover 200 to remain closed before being pushed out (e.g., ...). Figure 13 As shown). When the first push rod 600 pushes the cover 200 beyond the guide tube 500, the constraint force on the cover 200 disappears, and the cover 200 can change from a retracted state to an unfolded state (as shown). Figure 14 and Figure 15 As shown), the unfolded cover 200 can seal the atrial opening of the left atrial appendage, preventing the sealing body 100 from detaching from the atrial opening. Please refer to... Figure 16 And 17, then the second push rod 700 pushes the occlusion body 100 out of the first push rod 600 and drops it into the left atrial appendage. The occlusion body 100 can change from a compressed state to an expanded state, thereby occluding in the left atrial appendage (e.g. Figure 16 As shown). When the first push rod 600 retracts, it drives the cover 200 into the conduit 500. The inner wall of the conduit 500 exerts a restraining force on the cover 200, causing the cover 200 to retract and be stored in the conduit 500 (as shown). Figure 17 (As shown). Using the above-mentioned operating device 1000, only one channel needs to be opened for the catheter 500 to pass through. By operating the first push rod 600 and the second push rod 700, the left atrial appendage occluder can be delivered to the predetermined area (left atrial appendage). This avoids setting up multiple channels for multiple push rods, thereby reducing the difficulty of operation, reducing damage to the patient, and improving the reliability and safety of the operation.

[0053] In some embodiments, the cover 200 is provided with a through hole 220 for the sealing body 100 to pass through. The through hole 220 communicates with the inner cavity 610 of the first push rod 600, and the sealing body 100 is pushed out of the first push rod 600 through the through hole 220. Since the sealing body 100 is housed within the first push rod 600, it passes through the first push rod 600 and the through hole 220 of the cover 200 sequentially during the pushing process. This simplifies the movement path of the sealing body 100 during pushing and improves the reliability of the sealing body 100 during the pushing process. With this arrangement, the sealing body 100 can be inserted into the left atrial appendage without affecting the blocking effect of the cover 200, and the operation of inserting the sealing body 100 is simplified.

[0054] For other alternative implementations, please refer to [link / reference]. Figure 5 The cover 200 includes multiple interconnected support parts 210. The multiple support parts 210 interweave to form a mesh structure that can block and seal the main body 100. When the sealing main body 100 is in a compressed state, it can be pushed into a predetermined area position through any mesh hole of the mesh structure.

[0055] In some embodiments, please refer to Figure 12 A through hole 220 is located at the geometric center of the cover 200, and the through hole 220 has a threaded structure 221, through which the cover 200 is threadedly connected to the first push rod 600. The through hole 220's location at the geometric center of the cover 200 allows for a more uniform structural density distribution. For example, when the cover 200 is formed using a weaving method, the through hole 220 at the geometric center ensures more uniform stress distribution, improving the reliability of the cover 200 during use. Exemplarily, multiple support portions 210 are radially distributed, and the through hole 220 can be located at the intersection of the multiple support portions 210. In some examples, the unfolded projection of the cover 200 is circular, and the through hole 220 is located at the center of the circle. The threaded structure 221 allows for a detachable connection between the cover 200 and the first push rod 600, facilitating replacement of the first push rod 600 and the cover 200, and simplifying installation and disassembly operations.

[0056] For example, one end of the first push rod 600 is provided with an internal thread, and the through hole 220 of the cover 200 is provided with an external thread, and the cover 200 is screwed onto the first push rod 600. Alternatively, in other examples, one end of the first push rod 600 is provided with an external thread, and the inner wall of the through hole 220 of the cover 200 is provided with an internal thread, and the cover 200 is screwed onto the first push rod 600. Of course, in other alternative embodiments, the cover 200 and the first push rod 600 can also be fixedly connected, such as by bonding or welding.

[0057] In some embodiments, multiple occlusion bodies 100 of the left atrial appendage occluder are arranged sequentially along the axial direction of the first push rod 600. Thus, under the pushing action of the second push rod 700, the multiple occlusion bodies 100 can be pushed out of the first push rod 600 in sequence. Since the occlusion body 100 has a certain rigidity in the compressed state, the pushing force of the second push rod 700 can be transmitted from back to front to the foremost occlusion body 100, causing the occlusion body 100 to be pushed out.

[0058] In some embodiments, the inner diameter of the first push rod 600 is 5% to 10% larger than the outer diameter of the blocking body 100. The first push rod 600 allows the blocking body 100 to pass through individually, avoiding the stacking of multiple blocking bodies 100 that could cause blockage.

[0059] In some embodiments, the surface of the sealing body 100 may also be provided with a layer that can be visualized under X-rays. During the release of the sealing body 100, real-time observation with X-rays can confirm the release position of the sealing body 100 and ensure that all sealing bodies 100 are pushed out of the first push rod 600.

[0060] For other alternative implementations, please refer to Figure 18 Multiple sealing bodies 100 are arranged side-by-side in the inner cavity 610 of the first push rod 600, for example, distributed circumferentially or radially along the inner cavity 610. Multiple branch pipes 620 can be provided in the inner cavity 610, each branch pipe 620 containing one sealing body 100. Correspondingly, each branch pipe 620 contains a second push rod 700. Multiple second push rods 700 can move simultaneously, pushing out the sealing bodies 100 in their respective branch pipes 620 at the same time. For example, the outlets of the multiple branch pipes 620 are all connected to the through holes 220 of the cover 200, allowing multiple sealing bodies 100 to pass through the through holes 220 simultaneously. Therefore, the second push rods 700 can simultaneously push multiple sealing bodies 100 out of the first push rod 600.

[0061] Thirdly, please refer to Figure 19 This disclosure also provides a method for occlusion of the left atrial appendage, including the following steps.

[0062] Step S100: Insert the catheter 500 into the target location.

[0063] The target location can be a specific area of ​​the patient's body, such as the left atrial appendage or a location near the left atrial appendage. Figure 13 As shown.

[0064] Step S200: Push the first push rod 600 to send the cover 200 out of the conduit 500, and the cover 200 expands and unfolds.

[0065] like Figure 14 and Figure 15 As shown, after the cover 200 is freed from the constraint of the catheter 500, it can change from a compressed state to an expanded state. After the cover 200 is unfolded, it can cover the atrial opening of the left atrial appendage, preventing the occlusion body 100 from falling outside the left atrial appendage when it is subsequently released.

[0066] Step S300: Push the second push rod 700 to push the occlusion body 100 out of the first push rod 600, and release the occlusion body 100 into the left atrial appendage.

[0067] like Figure 16 As shown, the occlusion body 100 is kept in a compressed state under the constraint of the inner wall of the first push rod 600, and is pushed out of the first push rod 600 by the pushing action of the second push rod 700, and placed at the left atrial appendage. Then the occlusion body 100 can change from a compressed state to an expanded state to achieve the occlusion effect on the left atrial appendage.

[0068] Step S400: Pull the first push rod 600 to retract the cover 200 into the guide tube 500.

[0069] like Figure 17 As shown, when the first push rod 600 is pulled back, it can drive the cover 200 into the catheter 500. The inner wall of the catheter 500 has a restraining force on the cover 200, causing the cover 200 to retract and be stored in the catheter 500. Using the above-described left atrial appendage occlusion method, only one channel needs to be opened for the catheter 500 to pass through. By operating the first push rod 600 and the second push rod 700, the left atrial appendage occluder can be delivered to the predetermined area (left atrial appendage). This avoids setting up multiple channels for multiple push rods, thereby reducing the difficulty of operation, reducing damage to the patient, and improving the reliability and safety of the operation.

[0070] In some embodiments, step S300 further includes step S310: pushing the second push rod 700 to push the occlusion body 100 through the through hole 220 of the cover 200 and release it into the left atrial appendage. By utilizing the channel in the cover 200 to communicate with the inner cavity 610 of the first push rod 600, the occlusion body 100 can directly pass through the cover 200 via the through hole 220 and be deployed to the designated position, simplifying the movement path of the occlusion body 100 and making the process of pushing the occlusion body 100 out smoother.

[0071] In some embodiments, after step S300, the left atrial appendage occlusion method further includes step S500: the occlusion body 100 expands to restore the pores 110 within the occlusion body 100, and the bio-adhesive diffuses through the pores 110 to the outside of the occlusion body 100 to adhere the occlusion body 100 to the left atrial appendage. Using bio-adhesive to fix the occlusion body 100 achieves the goal of left atrial appendage occlusion, improves the adaptability and fit between the occlusion body 100 and the shape of the left atrial appendage, and avoids the use of occluders with metal skeletons, thus avoiding potential risks such as metal ion penetration and improving the ease and safety of left atrial appendage occlusion.

[0072] In some embodiments, before step S100, the left atrial appendage occlusion method further includes step S600: placing the occlusion body 100 into the inner cavity 610 of the first push rod 600, inserting the second push rod 700 into the inner cavity 610 of the first push rod 600, pushing the second push rod 700 to push the occlusion body 100 to the end of the first push rod 600 with the cover 200, inserting the first push rod 600 into the catheter 500, and retracting the cover 200 into the catheter 500.

[0073] Step S600 enables the preparation of the left atrial appendage occlusion device 1000, so that the device 1000 is in a usable state. Once prepared, the device 1000 can be used to place the left atrial appendage occlusion device. After the catheter 500 is inserted into the target position, it is convenient to carry out subsequent steps, such as pushing out the cover 200, pushing out the occlusion body 100, and retracting the cover 200.

[0074] In addition, to investigate the case of liquid bioadhesives, the following experiments are provided in this disclosure: Example 1 Polyurethane foam with an average pore size of 1500 micrometers around the periphery and 500 micrometers at the center. It is used in conjunction with cyanoacrylate bio-adhesive. The expansion time is approximately 4 minutes, and the diffusion-curing time of the bio-adhesive is approximately 4 minutes, achieving a bonding strength of approximately 15 MPa.

[0075] Example 2 Polylactic acid foam has an average pore size of 2500 micrometers around the periphery and 1000 micrometers at the center. It is used in conjunction with fibrin adhesive. The expansion time is approximately 1.5 minutes, and the diffusion-curing time of the bio-adhesive is also approximately 1.5 minutes. The adhesive strength can reach approximately 5 MPa.

[0076] Example 3 Polycaprolactone foam has an average pore size of 1800 micrometers around the periphery and 800 micrometers at the center. It is used in conjunction with polydopamine-based polyurethane adhesives. The expansion time is approximately 2 minutes, and the diffusion-curing time of the bio-adhesive is approximately 2 minutes, with an adhesive strength reaching approximately 8 MPa.

[0077] To more clearly illustrate the technical solutions disclosed herein, the technical means of this application are not limited to those disclosed in the above embodiments, but also include technical solutions composed of any combination of the above technical features. It should be noted that those skilled in the art can make several improvements and modifications without departing from the principles of this application, and these improvements and modifications are also considered within the scope of protection of this application.

Claims

1. A left atrial appendage occlusion device, characterized in that, It includes a sealing body, the sealing body being made of foam material, and the sealing body containing bio-adhesive to fill the pores of the sealing body.

2. The left atrial appendage occlusion device according to claim 1, characterized in that, It also includes a cover that can cooperate with the sealing body to restrict the position of the sealing body.

3. The left atrial appendage occlusion device according to claim 1, characterized in that, The volume of the occlusion body is more than 150% of the volume of the left atrial appendage.

4. The left atrial appendage occlusion device according to claim 1, characterized in that, The channels of the sealing body are interconnected.

5. The left atrial appendage occlusion device according to claim 1, characterized in that, The average diameter of each of the channels located at the center of the sealing body is small, while the average diameter of each of the channels located around the periphery of the sealing body is large.

6. The left atrial appendage occlusion device according to claim 1, characterized in that, The sealing body is composed of polyurethane, polycaprolactone, polylactide, polytrimethylene carbonate, polydodecaneglycerol, and poly(ω-pentadecanolactone).

7. The left atrial appendage occlusion device according to claim 1, characterized in that, The compressed sealing body can expand and recover.

8. The left atrial appendage occlusion device according to claim 1, characterized in that, The bio-adhesive includes one or more of the following: fibrin glue, polydopamine-type polyurethane adhesive, amino-containing polyester polyurethane, poly(N-isopropylacrylamide), and cyanoacrylate, and the bio-adhesive is in liquid state.

9. The left atrial appendage occlusion device according to claim 1, characterized in that, The bio-adhesive is in the form of powder.

10. The left atrial appendage occlusion device according to any one of claims 1-7 and 9, characterized in that, It includes multiple sealing bodies connected by connecting lines. The bio-adhesive is trilysine powder and polyethylene glycol powder, and the trilysine powder and the polyethylene glycol powder are placed in different sealing bodies.

11. The left atrial appendage occlusion device according to any one of claims 1-7 and 9, characterized in that, It includes a connecting line and multiple sealing bodies. The connecting line is sequentially inserted through the multiple sealing bodies. The multiple sealing bodies are slidable on the connecting line. The connecting line is elastic and is made of polydioxanone.

12. The left atrial appendage occlusion device according to any one of claims 2 to 9, characterized in that, The cover is provided with a through hole for the sealing body to pass through.

13. The left atrial appendage occlusion device according to claim 12, characterized in that, The through hole is located at the geometric center of the cover and has a threaded structure.

14. A left atrial appendage occlusion device operating apparatus, characterized in that, The device includes a catheter, a first push rod, a second push rod, and a left atrial appendage occluder as described in any one of claims 2 to 10, wherein one end of the first push rod is connected to the cap, and the first push rod is movably disposed within the catheter to push the cap out of the catheter or retract it into the catheter; The first push rod is hollow and is used to house the sealing body. The second push rod is movably disposed inside the first push rod and is used to push the sealing body out of the first push rod.

15. The operating device for the left atrial appendage occlusion device according to claim 14, characterized in that, The cover is provided with a through hole for the sealing body to pass through. The through hole is connected to the inner cavity of the first push rod, and the sealing body is pushed out of the first push rod through the through hole.

16. The operating device for the left atrial appendage occlusion device according to claim 14, characterized in that, The through hole is located at the geometric center of the cover, and the through hole has a threaded structure. The cover is threadedly connected to the first push rod.

17. The left atrial appendage occlusion device operating apparatus according to any one of claims 14 to 16, characterized in that, The plurality of occlusion bodies of the left atrial appendage occluder are arranged sequentially along the axial direction of the first push rod.

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