Medical systems and medical devices

Abstract

This invention relates to a medical system and a medical device. The medical system includes a delivery system and a biodegradable occluder. The occluder includes an occlusion body, a proximal fixation member, a distal fixation member, and an anchoring portion. The proximal end of the occlusion body is connected to the proximal fixation member, and the distal end is connected to the distal fixation member. The anchoring portion is disposed on the occlusion body. The delivery system includes an outer push tube and an inner push member. The outer push tube is detachably connected to the proximal fixation member, and the inner push member is detachably connected to the distal fixation member after passing through the outer push tube, the proximal fixation member, and the occlusion body in sequence. The delivery system applies axial pressure to the occluder, causing the occlusion body to expand from a collapsed structure to an expanded structure under pressure, and causing the anchoring portion to open outward with the expansion of the occlusion body. This invention solves the problem that biodegradable occluders cannot self-expand to a predetermined shape within the body cavity and cannot autonomously extend their spurs to anchor at the target location due to the lack of shape memory capability of biodegradable materials.

Description

Technical Field

[0001] This invention relates to the field of body cavity occlusion technology, and particularly to a medical system and medical device. Background Technology

[0002] Atrial fibrillation is the most common sustained arrhythmia in clinical practice, posing a risk of ischemic stroke. Data shows that in patients with non-valvular atrial fibrillation, over 90% of cardiac thrombi form in the left atrial appendage. Recent studies have demonstrated that occlusion of the left atrial appendage can effectively prevent the risk of ischemic stroke caused by atrial fibrillation. Since its first clinical application in 2001 for preventing thromboembolic events in atrial fibrillation, left atrial appendage occlusion has rapidly developed both domestically and internationally, becoming an important method for preventing thromboembolic events in patients with atrial fibrillation. Simultaneously, different types of left atrial appendage occlusion devices have emerged, better meeting clinical needs and improving surgical efficacy and safety.

[0003] Existing occluders used in left atrial appendage occlusion surgery can be broadly classified into two categories. One type is the cage-like occluder, represented by Watchman, characterized by a self-expanding, one-piece cut frame with anchoring hooks and a porous permeable membrane covering the atrial surface. It is inserted into the left atrial appendage cavity for occlusion. The other type is the dual-disc occluder, represented by Lambre, which consists of a positioning disc and an occlusion disc connected together. During use, the positioning disc is embedded in the left atrial appendage for anchoring and may also provide some occlusion, while the occlusion is primarily achieved by the occlusion disc, which is fitted to the opening of the left atrial appendage. Both types of occluders share a common characteristic: they are mainly made of nickel-titanium alloy, meaning they remain implanted for life. Because this material is non-degradable, long-term implantation can lead to inflammation, coagulation, and even damage to human tissues.

[0004] In addition, the following risks may exist: (1) Nickel-titanium alloy is a non-degradable metallic material. Although its biocompatibility has been demonstrated, the long-term risks of permanent implantation cannot be fully predicted and controlled; (2) There is a lack of long-term follow-up data on the safety of the left atrial appendage occluder remaining permanently in the heart; (3) There is no clear scientific evidence regarding complications such as nickel leaching and allergies. Furthermore, once the left atrial appendage orifice is completely endothelialized, the left atrial appendage occluder loses its function and there is no need for it to remain in the body. Therefore, an ideal left atrial appendage occluder should provide a temporary bridge for the endothelialization of the left atrial appendage orifice, and be degraded by the body after endothelialization is completed, so that the left atrial appendage occlusion is ultimately completed entirely by the body's own tissue, thereby avoiding long-term complications and safety hazards caused by foreign body retention.

[0005] While existing technologies have designed biodegradable left atrial appendage occluders, these studies primarily focus on materials and manufacturing processes, and have also proposed some structural designs. However, because biodegradable materials lack shape memory, the occluder cannot self-expand to the predetermined shape after being pushed out of the sheath. This affects the anchoring insertion, resulting in a lack of reliable connection between the occluder and the left atrial appendage, making it prone to detachment and threatening patient safety. Furthermore, it fails to effectively occlude the left atrial appendage, impacting surgical efficacy. Moreover, occluders used for atrial / ventricular septal defects or in other environments may face similar problems. Summary of the Invention

[0006] In view of the problems existing in the prior art, the purpose of the present invention is to provide a medical system and medical device to solve the problem that existing biodegradable occluders cannot expand to a predetermined shape in the body and cannot autonomously extend their punctures to anchor at the target location because biodegradable materials have no shape memory capability.

[0007] According to a first aspect of the present invention, a medical system is provided, comprising a delivery device and a biodegradable occluder;

[0008] The occluder includes an occluder body, a proximal fixing member, a distal fixing member, and an anchoring part; the proximal end of the occluder body is connected to the proximal fixing member, the distal end is connected to the distal fixing member, and the anchoring part is disposed on the occluder body;

[0009] The delivery device includes an outer push tube and an inner push member; the outer push tube is detachably connected to the proximal fixation member; the inner push member is detachably connected to the distal fixation member after passing through the outer push tube, the proximal fixation member, and the occlusion body in sequence.

[0010] The medical system is configured such that the delivery device applies axial pressure to the occluder, causing the occluder body to expand from a collapsed structure to an expanded structure after being compressed, and causing the anchoring portion to open outward as the occluder body expands.

[0011] Optionally, the sealing body includes a biodegradable metal support and an anchoring portion integrally formed with the metal support.

[0012] Optionally, the metal bracket includes a plurality of support rods arranged circumferentially; at least a portion of the support rods are cut in the middle to form the anchoring portion; the anchoring portion has a head end and a tail end, the tail end being connected to the metal bracket, and the head end being a free end;

[0013] The anchoring portion is formed by cutting from one side of the middle portion of the support rod, and / or the width of the middle portion of the support rod is greater than the width of the remaining portions.

[0014] Optionally, the occluder has an initial state and an inflated state;

[0015] When the plug is in the initial state, the extension direction of the anchoring part forms a negative angle with the positive direction of the axis of the plugging body, and / or the outline of the anchoring part along the length direction is arc-shaped;

[0016] When the plug is in the expanded state, the extension direction of the anchoring part forms a positive angle with the positive direction of the axis of the plugging body, and / or the outline of the anchoring part along the length direction is arc-shaped.

[0017] Optionally, the negative angle is -50° to -30°, and the positive angle is 20° to 40°.

[0018] Optionally, the inner pusher is a rod or a flexible body.

[0019] Optionally, the sealing body includes a biodegradable metal support and a sealing disc woven from biodegradable polymer material;

[0020] The metal support and the sealing disc are connected by a hollow connecting pipe; the anchoring part is disposed on the metal support; the distal end of the metal support is connected to the distal fixing member, and the proximal end of the sealing disc is connected to the proximal fixing member.

[0021] Optionally, the hollow connecting tube is an elastic structure.

[0022] Optionally, the hollow connecting tube is a spring integrally cut from the metal bracket.

[0023] Optionally, a connecting part is provided at the proximal end of the hollow connecting tube, and the connecting part is provided with a through hole; the connecting part is thermally fused to the distal end of the sealing disc.

[0024] Optionally, the plugger is configured such that, upon being subjected to axial pressure applied by the conveyor, the metal support and the plugging disc expand simultaneously or sequentially.

[0025] Optionally, the plug is made of a biodegradable metallic material and / or a biodegradable polymer material;

[0026] The biodegradable metallic material includes at least one of magnesium-based metals, zinc-based metals, and iron-based metals, and the biodegradable polymeric material includes at least one of polylactic acid, polydioxanone, polycaprolactone, polyglycolic acid, and polyglycolic acid.

[0027] Optionally, the medical system further includes a limiting device for controlling the expansion size of the occluder.

[0028] Optionally, the limiting device includes a limiting buckle and a limiting groove; when the plug expands to a predetermined size, the limiting groove cooperates with the limiting buckle.

[0029] According to a second aspect of the present invention, a medical device is provided, made of a biodegradable material, comprising a biodegradable metal stent and an anchoring portion connected to the metal stent;

[0030] When the medical device is subjected to axial pressure, the metal stent expands from a collapsed structure to an expanded structure, and the anchoring portion opens outward as the metal stent expands.

[0031] Optionally, the medical device further includes an occlusion disc woven from a biodegradable polymer material; the metal stent and the occlusion disc are connected by a hollow connecting tube.

[0032] Optionally, the ratio of the width of the middle part of the support rod to the width of other areas is 1.1 to 1.3:1; and / or, the ratio of the width of the middle part of the support rod excluding the anchoring part to the width of other areas is 0.85 to 0.95:1.

[0033] In the medical system and medical device provided by this invention, the occluder (medical device) is biodegradable, which solves the long-term complications and safety hazards caused by long-term implantation of occluders. On the other hand, even if the biodegradable material of the occluder does not have shape memory ability, the occluder can be expanded to a predetermined shape after exiting the sheath by applying axial pressure through the delivery device, thereby achieving effective occlusion of the target site (such as patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosus, or other congenital heart diseases), ensuring the occlusion effect and improving the surgical efficacy. Furthermore, as the occluder expands, it can also drive the anchoring part on it to open outward and insert into the target position for fixation, realizing a stable and reliable connection between the occluder and the target position, improving the reliability of the occluder fixation, ensuring the safety of the occlusion, and ensuring the patient's life safety.

[0034] In the medical system and medical device provided by the present invention, the occluder preferably includes a biodegradable metal stent, and the anchoring portion is integrally cut and formed with the metal stent. This not only facilitates the forming and anchoring but also ensures the strength of the occluder. In particular, the anchoring portion can be formed by cutting from one side of the middle portion of the support rod of the metal stent, and / or the width of the middle portion of the support rod of the metal stent is designed to be 1.1 to 1.3:1 in ratio with the width of other areas; and / or the width of the middle portion of the support rod excluding the anchoring portion is 0.85 to 0.95:1 in ratio with the width of other areas. This improves the structural strength of the metal stent and makes the occluder more securely placed in the body.

[0035] In the medical system and medical device provided by the present invention, before the occluder is expanded, the anchoring part is preferably pre-bent to control the shape and angle of the anchoring part. For example, before expansion, the extension direction of the anchoring part forms a negative angle with the positive direction of the axis of the occluder, and / or, before expansion, the outline of the anchoring part along the length direction is arc-shaped. With this construction, the opening angle of the anchoring part after the occluder is expanded is appropriate, and it is not easy for the anchoring part to fall off the target position, thereby improving the stability of the connection.

[0036] In the medical system and device provided by this invention, the occluder preferably includes a biodegradable metal stent and an occlusion disc woven from a biodegradable polymer material. The metal stent and the occlusion disc are connected by a hollow connecting tube, and the anchoring part is disposed on the metal stent. This structure enhances the fixation and occlusion performance of the occluder. Specifically, the occlusion disc is woven from a biodegradable polymer material, which is soft and compliant, thus improving the fit between the occlusion disc and the body cavity opening (such as the fit with the left atrial appendage opening) and enhancing the effectiveness of the occlusion. Simultaneously, the soft occlusion disc helps reduce or even eliminate damage to the body cavity opening and surrounding tissues, improving the safety of the occlusion. The use of a strong metal stent helps improve the fixation of the occlusion and prevents it from dislodging.

[0037] In the medical system and medical device provided by the present invention, the hollow connecting tube is preferably an elastic structure, such as a spring or a metal cutting tube, so that the occluder can adapt to body cavities (such as the left atrial appendage) with different axes of the body and mouth, thereby improving the adaptability of the occluder.

[0038] In the medical system and medical device provided by the present invention, a limiting device is preferably also included to control the expansion size of the occluder, thereby precisely controlling the expansion of the occluder and making the operation simpler and more convenient. Attached Figure Description

[0039] Figure 1a This is a schematic diagram of the blocker in a preferred embodiment of the present invention;

[0040] Figure 1b This is a front view of the medical system in a preferred embodiment of the present invention;

[0041] Figure 2a This is a schematic diagram of the state of the plug after it is pushed out of the sheath and before the anchoring part extends, according to a preferred embodiment of the present invention.

[0042] Figure 2b This is a schematic diagram of the state when the plug is undergoing pushing and expanding and the anchoring part is extended in a preferred embodiment of the present invention;

[0043] Figure 2cThis is a schematic diagram of the state of the inner pusher and the outer pusher tube before they are withdrawn after the plugger is pushed and expanded and the anchoring part extends in a preferred embodiment of the present invention.

[0044] Figure 3 This is a schematic diagram of the state of the plug before expansion after release in a preferred embodiment of the present invention;

[0045] Figure 4 This is a schematic diagram showing the state of the plugging device under pressure and the anchoring part extending in a preferred embodiment of the present invention;

[0046] Figure 5 This is a schematic diagram of the state of the plug after being compressed and expanded and the anchoring part is extended in a preferred embodiment of the present invention;

[0047] Figure 6 This is a schematic diagram of the state after the plugging device has undergone pressure expansion and the anchoring part has extended in a preferred embodiment of the present invention, with the outer push tube and inner push member removed;

[0048] Figure 7 This is a schematic diagram of the structure of the anchoring part on the plugger in a preferred embodiment of the present invention;

[0049] Figure 8a This is a schematic diagram of the anchoring portion of the plugger in a preferred embodiment of the present invention, before it has undergone pre-bending treatment and before expansion.

[0050] Figure 8b for Figure 8a A schematic diagram of the state of the anchoring part of the central plug after expansion without pre-bending treatment;

[0051] Figure 9a This is a schematic diagram of the anchoring part of the plugger after angular pre-bending treatment when it is not expanded, in a preferred embodiment of the present invention;

[0052] Figure 9b for Figure 9a A schematic diagram of the state of the anchoring part of the central plug after expansion and pre-bending at an angle;

[0053] Figure 10a This is a schematic diagram of the anchoring portion of the plugger in a preferred embodiment of the present invention, after pre-bending in terms of angle and shape when it is not expanded;

[0054] Figure 10b for Figure 10a A schematic diagram of the state of the anchoring part of the central plug after expansion and pre-bending treatment of angle and shape;

[0055] Figure 11 This is a schematic diagram of the hollow connecting tube in a preferred embodiment of the present invention;

[0056] Figure 12 This is a three-dimensional structural diagram of a plug with a limiting device in a preferred embodiment of the present invention.

[0057] The following are the descriptions of the reference numerals:

[0058] 10-Occluder;

[0059] 11-Fixing plate; 111-Support rod; 12-Sealing plate;

[0060] 13-Hollow connecting pipe; 131-Spring section; 132-Connecting part; 133-Hole;

[0061] 14-Proximal fastener; 15-Distal fastener; 16-Anchoring part; 161-Tail end; 162-Head end;

[0062] 17-Limiting device; 171-Limiting slot; 172-Limiting buckle;

[0063] 20-Conveyor;

[0064] 21-External push tube; 22-Internal push component;

[0065] 30 - Left atrial appendage;

[0066] 40-liner. Detailed Implementation

[0067] To make the objectives, advantages, and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clearly illustrate the objectives of the embodiments of the present invention.

[0068] It should be understood that the structures, proportions, sizes, etc., illustrated in the accompanying drawings of this specification are merely for illustrative purposes to aid those skilled in the art and are not intended to limit the scope of the invention. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in proportions, or adjustments to size, without affecting the effectiveness and purpose of the invention, should still fall within the scope of the technical content disclosed in this invention. Furthermore, the terms such as "upper," "lower," "left," "right," "middle," and "one" used in this specification are merely for clarity and are not intended to limit the scope of the invention. Changes or adjustments to their relative relationships, without substantially altering the technical content, should also be considered within the scope of the invention.

[0069] In this article, the proximal end refers to the end of the occluder or medical device that is closer to the surgeon, the distal end refers to the end of the occluder or medical device that is farther from the surgeon, and the radial direction refers to the direction perpendicular to the axis of the occluder or medical device.

[0070] As mentioned in the background section, while existing occluders for sealing left atrial appendage and atrial / ventricular septal defects utilize biodegradable materials, these materials lack shape memory and cannot self-expand to a predetermined shape after deployment. This not only affects the reliable connection between the occluder and the target location, making it prone to dislodgement and reducing safety, but also prevents effective sealing of the target site, impacting surgical efficacy. For example, most existing left atrial appendage occluders are made of nickel-titanium alloy materials, either cut (e.g., the Watchman occluder) or woven (e.g., the Lambre occluder). Once implanted, they remain permanently in the heart, posing unknown long-term risks and safety hazards. While biodegradable occluders can avoid these problems, currently proposed biodegradable occluders do not solve the issues of connection between the occluder and the left atrial appendage, or the inability to return to the predetermined shape after deployment, leading to ineffective sealing.

[0071] To address the aforementioned technical problems, this invention proposes a novel medical system comprising an occluder and a delivery device. This occluder can be applied to the left atrial appendage, and also to conditions such as patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosus, or other congenital heart diseases. This invention also proposes a medical device comprising a biodegradable metal stent and an anchoring portion connected to the metal stent. The anchoring portion is also biodegradable and preferably integrally cut and formed with the metal stent.

[0072] To illustrate the technical solution provided by this invention, a left atrial appendage occluder is used as an example. The occluder provided by this invention is not only biodegradable, avoiding long-term complications and safety hazards associated with long-term implantation, but also, even without shape memory properties, allows the occluder to expand to a predetermined shape, ensuring the occlusion performance of the left atrial appendage. Furthermore, it achieves a stable and reliable connection between the occluder and the left atrial appendage, improving the fixation reliability and safety of the occluder, thus ensuring patient safety. More specifically, after the occluder is delivered to the ideal position within the body by the delivery device, it is pushed out of the sheath. Subsequently, the occluder is controlled by the delivery device to expand under pressure, reaching a predetermined shape. Simultaneously, the expansion of the occluder causes its anchoring portion to open outwards and penetrate the inner wall of the left atrial appendage. It should be understood that the occluder of this invention can be a cage-like internal plug occluder or a double-disc occluder; the double-disc occluder can be used for either external or internal occlusion.

[0073] The occluder is made of biodegradable materials, such as biodegradable polymers or biodegradable metals. Specifically, if a cage-type occluder is used, the occluder consists of only one cage-type support, which is integrally cut from a biodegradable metal or biodegradable polymer, preferably from a biodegradable metal tube. If a dual-disc occluder is used, the occluder includes a fixed disc and an occluding disc. The fixed disc and the occluding disc can be manufactured in the same or different ways. Furthermore, the fixed disc is generally a cage-type support cut from a biodegradable metal tube, while the occluding disc can be integrally cut or woven from a biodegradable metal or biodegradable polymer, preferably woven from a biodegradable polymer. Biodegradable metals include, but are not limited to, magnesium-based metals (such as magnesium alloys), zinc-based metals (zinc alloys), or iron-based metals (iron alloys). Biodegradable polymers include, but are not limited to, polylactic acid, polydioxanone, polycaprolactone, polyglycolic acid, and polyglycolic acid-propylene glycol. It should be understood that occluders can be fabricated using one or more biodegradable metallic materials, or one or more biodegradable polymeric materials. Furthermore, the occluder can be made entirely of biodegradable metallic materials, entirely of biodegradable polymeric materials, or simultaneously of both. It should also be understood that, in practical use, a dual-disc occluder can be used by inserting both the fixing disc and the occluding disc as a whole into the left atrial appendage for occlusion, or by inserting only the fixing disc into the left atrial appendage while the occluding disc is placed at the external opening. Alternatively, in cases of atrial septal defects, the fixing disc and the occluding disc can be used to occlude from both sides of the atrial septum.

[0074] Whether it is a dual-disc or cage-like inner plug type, the occluder of the present invention should include an occluder body made of biodegradable material, a proximal fixing member, a distal fixing member, and an anchoring part. The proximal end of the occluder body is connected to the proximal fixing member, and the distal end is connected to the distal fixing member. An anchoring part is provided on the occluder body. If it is a cage-like inner plug type, the occluder body preferably includes a cage-like support cut from a metal tube. The proximal and distal ends of the cage-like support are respectively provided with a proximal fixing member and a distal fixing member. If it is a dual-disc type, the occluder body includes an occluder disc and a fixing disc. The distal end of the occluder disc and the proximal end of the fixing disc are connected by a hollow connecting tube. A distal fixing member is provided at the distal end of the fixing disc, and a proximal fixing member is provided at the proximal end of the occluder disc.

[0075] Furthermore, the delivery device includes an outer push tube and an inner push member. The outer push tube is detachably connected to the proximal fixation member, and the inner push member is detachably connected to the distal fixation member after passing through the outer push tube, the proximal fixation member, and the occlusion body. In actual use, after the occluder is delivered to the ideal position by the delivery device and pushed out from the sheath, as long as one of the outer push tube and the inner push member remains stationary while the other moves in a predetermined direction (the predetermined direction is the direction of movement towards the proximal or distal end), the occluder will expand from a collapsed structure to an expanded structure under axial pressure. During the expansion of the occluder, the originally retracted anchoring part gradually opens outward and finally penetrates the inner wall of the left atrial appendage. After ensuring a stable connection between the occluder and the left atrial appendage, the inner push member and the outer push tube can be withdrawn sequentially to complete the occlusion of the left atrial appendage.

[0076] Next, to make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings. For the sake of simplicity, the following description assumes that the occluder is a dual-disc occluder; those skilled in the art should be able to modify the following description, making appropriate modifications to the details, to apply it to the case of a cage-like internal plug. Similarly, for illustrative purposes, the following description assumes that the occluder is a left atrial appendage occluder; those skilled in the art should be able to modify the following description, making appropriate modifications to the details, to apply it to cases where it is not a left atrial appendage occluder.

[0077] Figure 1a This is a schematic diagram of the blocker in a preferred embodiment of the present invention. Figure 1b This is a front view of the medical system in a preferred embodiment of the present invention. Figure 1a and Figure 1b As shown, this embodiment provides a medical system including an occluder 10 and a delivery device 20. The occluder 10 is used to occlude the left atrial appendage. The delivery device 20 is used to control the delivery, release, and retrieval of the occluder 10.

[0078] The occluder 10 includes an occlusion body, which is entirely made of medical biodegradable material and includes a fixation plate 11 and an occlusion plate 12. In another embodiment, only the fixation plate 11 is used without the occlusion plate 12, and the occluder body consists only of the biodegradable fixation plate 11. The processing method of the fixation plate 11 and the occlusion plate 12 is not limited, and they can each be obtained by cutting or weaving. Generally, the fixation plate 11 is formed by cutting biodegradable metal tubing. In this case, the fixation plate 11 is a biodegradable metal support, thereby ensuring the strength and good shaping ability of the fixation plate 11. However, it is not limited to this. If biodegradable polymer materials can achieve the same or similar effects, the fixation plate 11 can also be obtained by weaving or cutting. The occlusion plate 12 is generally woven from biodegradable polymer materials. The occlusion plate 12 is more flexible than the fixation plate 11, making the occluder more compliant. For example, optionally, the material of the fixation plate 11 is magnesium alloy, and the material of the occlusion plate 12 is polylactic acid.

[0079] The occluder 10 further includes a hollow connecting tube 13, a proximal fixing member 14, a distal fixing member 15, and an anchoring part 16. The proximal end of the fixing plate 11 and the distal end of the occlusion plate 12 are connected by the hollow connecting tube 13. The hollow connecting tube 13 has an axially penetrating inner cavity and is preferably integrally formed with the fixing plate 11. If integrally cut and formed, it is convenient to simplify the structure and processing technology. The proximal fixing member 14 is disposed at the proximal end of the occlusion plate 12 and is preferably integrally formed with the occlusion plate 12. If the occlusion body of the occluder does not include the occlusion plate 12, then the proximal fixing member 14 is disposed at the proximal end of the fixing plate 11. The distal fixing member 15 is disposed at the distal end of the fixing plate 11 and is preferably integrally formed with the fixing plate 11. Optionally, the hollow connecting tube 13 is made of magnesium alloy, the proximal fixing member 14 is made of polylactic acid, and the distal fixing member 15 is made of magnesium alloy. The anchoring part 16 is connected to the fixing plate 11, and preferably the anchoring part 16 and the fixing plate 11 are integrally cut and formed.

[0080] The delivery device 20 includes an outer pushing tube 21 and an inner pushing member 22. The inner pushing member 22 can be a rod capable of axial compression or a flexible body capable of axial tension (such as a wire, rope, or cord, preferably a guide wire). Flexible bodies are relatively smaller, which helps reduce the size of the delivery device 20. The flexible body can be detachably connected to the distal fixing member 15 via perforations. There can be one or more perforations, and the axis of the perforations can be parallel or perpendicular to the axis of the fixing plate 11. The outer pushing tube 21 is detachably connected to the proximal fixing member 14 of the occluder 10 to achieve the purpose of pushing, adjusting, and expanding the occluder 10. The inner pushing member 22 passes sequentially through the outer pushing tube 21, the proximal fixing member 14, the hollow connecting tube 13, and the fixing plate 11 before being detachably connected to the distal fixing member 15. This allows it to cooperate with the outer pushing tube 21 during expansion to provide an axial pressure to the occluder 10, causing the occluder 10 to expand radially. The connection method between the outer push tube 21 and the proximal fixation member 14 can be adjusted according to actual needs, such as selecting one or more combinations of mechanical connections or other non-mechanical connection methods, such as threads, snaps, clamps, and perforations. Similarly, the connection method between the inner push member 22 and the distal fixation member 15 can be adjusted according to actual needs. The detachable connection can be one or more combinations of mechanical connections or other non-mechanical connection methods, such as threads, snaps, clamps, and perforations. In addition, the inner push member 22 and the outer push tube 21 can choose the same or different connection methods. For example, when the outer push tube 21 is threaded, the inner push member 22 can be threaded or other connection methods. This invention does not have any particular requirements for this. In this embodiment, the outer push tube 21 is threaded to the proximal fixation member 14, and the inner push member 22 is threaded to the distal fixation member 15. For example, both the proximal fixation member 14 and the distal fixation member 15 have internal threads, and both the outer push tube 21 and the inner push member 22 have external threads that mate with the internal threads.

[0081] The occluder 10 has an initial state in which it does not expand, such as... Figure 2a As shown, the axial length is relatively long and the radial dimension is small, meaning that the plug 10 is in a collapsed structure at this time; the plug 10 also has an expanded state, in which the plug 10 is compressed axially and expanded radially, as shown. Figure 2b and Figure 2cAs shown. In practical applications, the occluder 10 is initially pre-installed inside the sheath and connected to the inner pusher 22 and the outer pusher tube 21. When the occluder 10 is delivered to the ideal position and pushed out of the sheath, one of the outer pusher tube 21 and the inner pusher 22 remains stationary while the other moves in a predetermined direction. This causes the occluder 10 to expand from a collapsed structure to an expanded structure under axial pressure. During the expansion of the occluder 10, the previously retracted anchoring part 16 gradually opens outward and finally penetrates the inner wall of the left atrial appendage. Typically, once the occluder 10 has expanded radially to the predetermined size and the occluder 10 is securely connected to the left atrial appendage, the inner pusher 22 and the outer pusher tube 21 can be withdrawn sequentially to complete the occlusion of the left atrial appendage.

[0082] It should be understood that traditional non-degradable anchors have shape memory function and can open outwards autonomously. However, the anchor portion 16 in this embodiment is degradable and cannot open outwards autonomously. Therefore, it is necessary to use the expansion of the fixing plate 11 to cause the anchor portion 16 to open outwards, thereby allowing the anchor portion 16 to penetrate the inner wall of the left atrial appendage. Furthermore, because the anchor spike (the anchor spike is the anchor portion 16) is cut and formed on the support rod 111 of the fixing plate 12, the width of the support rod (i.e., the support rod forming the anchor spike) at this location will be reduced. Therefore, it is more prone to bending than other parts. As a result, when the occluder 10 changes from a collapsed state to an expanded or extended state, it will naturally expand in the area where the anchor portion 16 is located.

[0083] More in detail, such as Figure 2a As shown, when the occluder 10 is pushed out of the sheath, and the inner pusher 22 and outer pusher tube 21 are not operated, the occluder 10 is in its initial state. At this time, neither the fixed plate 11 nor the occlusion plate 12 has expanded, and the fixed plate 11 is located at the distal end of the occlusion plate 12; Figure 2b As shown, operating the outer push tube 21 and the inner push member 22, for example, keeping the outer push tube 21 stationary and moving the inner push member 22 proximally, or keeping the inner push member 22 stationary and moving the outer push tube 21 distally, or moving the outer push tube 21 and the inner push member 22 simultaneously toward each other, any of these methods can cause the occluder 10 to be compressed axially (e.g. Figure 2b The direction indicated by the horizontal arrow is under pressure, the axial length shortens, and the radial expansion occurs (as shown by the horizontal arrow). Figure 2b As the vertical arrow in the middle expands (in the direction of expansion), the radial dimension increases. At this time, as the fixed plate 11 expands, the anchoring part 16 on the fixed plate 11 also opens outwards. When the anchoring part 16 opens outwards, the extension direction of the anchoring part 16 forms a positive angle with the positive direction of the axis of the plug 10. The positive direction of the axis of the plug is the direction from the distal end to the proximal end of the plug 10, and the extension direction (i.e., the length direction) of the anchoring part 16 is the direction from the tail end to the head end of the anchoring part 16. Figure 2cAs shown, as the occluder 10 is further compressed, its radial dimension continuously increases, while the opening angle of the anchoring portion 16 also continuously increases, ultimately causing the anchoring portion 16 to face and penetrate the inner wall of the left atrial appendage. It should be understood that in Figure 2b and Figure 2c The lower right corner of the dashed box also shows an enlarged view of part A, which is indicated by the solid rectangle on the fixed plate 11, to explain the structural state of the anchoring part 16 on the fixed plate 11 as the fixed plate 11 expands.

[0084] Further reading Figures 3 to 6 The preferred operation process of the occluder 10 in this embodiment will be further explained below. First, as follows... Figure 3 As shown, after the occluder 10 is delivered to the ideal position (e.g., the fixing disc 11 is located inside the left atrial appendage 30, and the occlusion disc 12 is located outside the left atrial appendage 30 and corresponds to the opening of the left atrial appendage) and pushed out from the sheath, before expansion, the position and angle of the occluder 10 can be adjusted by moving or rotating it through the outer push tube 21 or the inner push member 22; then, as Figure 4 and Figure 5 As shown, after the operator adjusts the position and angle of the occluder 10, keeping the inner pusher 22 stationary, the outer pusher tube 21 moves distally, causing the occluder 10 to expand from a collapsed state to an inflated state under pressure. During the expansion process, the anchoring part 16 on the fixed plate 11 opens away from the axis of the fixed plate 11, and as the occluder 10 expands, the anchoring part 16 gradually penetrates the inner wall of the left atrial appendage, thereby forming a stable and reliable connection. Further as... Figure 6 As shown, after the occluder 10 is successfully released, expanded and anchored, the operator removes the inner pusher 22 and the outer pusher tube 21 from the body one after another to complete the occlusion surgery.

[0085] It should also be noted that the expansion sequence of the dual-disc occluder 10 can actually be adjusted. For example, the occluder disc 12 can expand first, followed by the fixed disc 11; or the fixed disc 11 can expand first, followed by the occluder disc 12; or both the fixed disc 11 and the occluder disc 12 can expand simultaneously. These methods can be controlled by factors such as materials and dimensions. For example, if the fixed disc 11 is more flexible than the occluder disc 12, after the occluder 10 is pushed out of the sheath, under axial pressure, the fixed disc 11 expands first, and the occluder disc 12 only begins to expand after the fixed disc 11 has completed its expansion. If the occluder disc 12 is more flexible than the fixed disc 11, after the occluder 10 is pushed out of the sheath, under axial pressure, the occluder disc 12 expands first, and the fixed disc 11 only begins to expand after the occluder disc 12 has completed its expansion. If the occluder disc 12 and the fixed disc 11 are of similar flexibility, they can expand simultaneously, that is, after being pushed out of the sheath, under axial pressure, the occluder disc 12 and the fixed disc 11 begin to expand simultaneously. Here, adjusting the expansion sequence facilitates the surgeon's operation. Typically, the occlusion disc 12 is woven from a biodegradable polymer material, such as polylactic acid, while the fixation disc 11 is cut from a biodegradable metal tube, such as magnesium alloy. This design gives the occlusion disc 12 a soft and compliant nature, enhancing its fit with the left atrial appendage and improving occlusion effectiveness. Simultaneously, the soft occlusion disc 12 helps reduce or even eliminate damage to the left atrial appendage and surrounding tissues, improving occlusion safety. The use of a strong metal fixation disc 11 improves occlusion stability and prevents it from dislodging from the left atrial appendage.

[0086] Compared with existing technologies, this invention causes the main body of the occluder 10 to expand radially by applying axial pressure to its proximal and distal ends. Simultaneously, the expansion causes the anchoring part 16 to extend and gradually penetrate the inner wall of the left atrial appendage, forming a stable connection to complete the occlusion. This structure overcomes the problem that biodegradable occluders, due to the lack of shape memory in their material, cannot expand to a predetermined shape after being ejected from the sheath. Furthermore, the anchoring part 16, extending during the pushing process, can form a stable connection with the left atrial appendage 30, solving the problem that current biodegradable left atrial appendage occluders cannot reliably connect with the left atrial appendage.

[0087] Furthermore, such as Figure 7As shown, the anchoring portion 16 is preferably integrally cut and formed with the fixing plate 11. The fixing plate 11 includes multiple support rods 111 arranged circumferentially, and at least a portion of the support rods 111 have anchoring portions 16 cut into their middle sections. In this embodiment, the anchoring portion 16 is cut and formed in the middle of each support rod 111. The anchoring portion 16 has opposing tail ends 161 and head ends 162. The tail ends 161 are connected to the fixing plate 11, and the head ends 162 are free ends. The head ends 162 are preferably constructed as pointed portions, which are easier to penetrate into the inner wall of the left atrial appendage. Here, the support rods 111 and the anchoring portions 16 are formed simultaneously when cutting the metal tube, which simplifies the process and makes manufacturing more convenient. In specific operation, the support rods 111 can be obtained first (e.g., by cutting or weaving), and then the edge contour of the anchoring portion 16 can be cut out on the support rods 111. Then, the anchoring portion 16 is bent outward from the support rods 111.

[0088] Considering that the strength of biodegradable materials is not as high as that of non-biodegradable materials such as nickel-titanium, in some embodiments, it is preferable to cut from one side of the middle portion of the support rod 111 to form the anchoring portion 16, so as to ensure the width of the remaining portion of the support rod 111 as much as possible, thereby ensuring the strength of the fixing plate 11. In other embodiments, the width of the middle portion of the support rod 111 can be designed to be greater than the width of the rest of the support rod. In this case, the strength of the support rod 111 will not be reduced after cutting the anchoring portion 16. In other embodiments, while increasing the width of the middle portion of the support rod 111, a cut can also be made on one side of the support rod 111. In addition, when increasing the width of the middle portion of the support rod 111, a cut can be made either on one side of the support rod 111 or inside the support rod 111. Furthermore, it should be understood that the middle portion of the support rod 111 should not be narrowly interpreted as an absolute center position. That is, the present invention does not limit the position of the middle portion of the fixing plate 11 relative to the central axis; it can be at the central axis or off the central axis. See also Figure 1a and Figure 1b The anchoring part 16 is mainly located in the middle of the fixed plate 11. When the fixed plate 11 is subjected to axial pressure, the middle part of the fixed plate 11 bends to both sides. By setting the anchoring part 16 at the maximum outer diameter of the fixed plate 11 after expansion, it is easy for the anchoring part 16 to effectively extend and penetrate the inner wall of the left atrial appendage.

[0089] Because biodegradable metals, such as magnesium alloys, are less strong than nickel-titanium alloys and are prone to stress concentration at bends, the support rod 111 may break due to these two factors. To avoid this risk, firstly, the bending angle (curvature) should not be too large during expansion; secondly, the anchor bar can be cut from one side, with the remaining width of the anchor bar slightly larger than the width of the rod at other points, and the remaining width slightly smaller than the width of the rod at other points. Preferably, the width of the support rod 111 before cutting the anchor bar is (1.1~1.3)b 1 (e.g. Figure 7As shown, b1 is the width of the support rod excluding the anchor portion, and / or, the remaining width b2 of the support rod 111 after snagging is (0.85~0.95)b1. It should be understood that the width of the support rod before snagging refers to the width of the portion of the support rod where the anchor portion needs to be cut, i.e., before snagging, the width of the middle part of the support rod is preferably in a ratio of 1.1 to 1.3:1 to the width of other areas; furthermore, the remaining width of the support rod after snagging is the width of the middle part of the support rod excluding the anchor portion, i.e., after snagging, the width of the middle part of the support rod excluding the anchor portion is preferably in a ratio of 0.85 to 0.95:1 to the width of other areas. Furthermore, the inventors have found through numerous experimental studies that designing the width of the support rod before and after snagging within the above range can significantly improve the mechanical properties of the support rod and ensure its strength.

[0090] like Figure 7 As shown, in the expanded state, the extension direction of the anchoring part 16 forms an acute angle α with the positive direction of the axis of the fixed disk 11. The positive direction of the axis of the fixed disk 11 is the direction from the far end to the near end of the fixed disk 11. The extension direction of the anchoring part 16 is the length direction, and the length direction of the anchoring part 16 is the direction from its tail end 161 to its head end 162. Arrow L1 points to the far end, and arrow L2 points to the near end. It should be understood that when the fixed disk 11 is compressed and expanded, the fixed disk 11 will bend at the middle position along the axial direction, and the curvature gradually increases as the expansion proceeds. During this process, since the tail end 161 (i.e., the root) of the anchoring part 16 is connected to the fixed disk 11, while the head end 162 of the anchoring part 16 is separated from the fixed disk 11, the anchoring part 16 does not bend accordingly. Therefore, during the expansion of the fixation plate 11, the anchoring part 16, which was originally contained within the fixation plate 11, gradually extends out and penetrates the inner wall of the left atrial appendage as the fixation plate 11 expands, forming a stable connection with the inner wall of the left atrial appendage. Furthermore, considering that excessive length L and angle α of the anchoring part 16 may lead to risks such as pericardial effusion, tamponade, and device dislodgement, it is necessary to control the shape and angle of the anchoring part 16 after expansion. For this reason, the anchoring part 16 is pre-bent before the fixation plate 11 expands.

[0091] If the anchoring part 16 is not pre-bent, before expansion, such as Figure 8a As shown, the anchoring part 16 is not open outwards. At this time, the angle α formed by the extension direction of the anchoring part 16 and the positive direction of the axis of the fixing plate 11 can be 0° or slightly larger or smaller than 0°. Thus, after expansion, if, as shown in 8b, the anchoring part 16, without pre-bending treatment, opens outwards, the angle α is larger, making it easier to detach from the inner wall of the left atrial appendage. Conversely, if the anchoring part 16 is pre-bent to control its angle, before expansion, as shown in 8b... Figure 9aAs shown, the anchoring part 16 is folded inward at a certain angle (negative angle). At this time, the extension direction of the anchoring part 16 forms a negative angle with the positive direction of the axis of the fixing plate 11. The folding angle is preferably -50° to -30°, and more preferably -40°. Then, after expansion, as... Figure 9b As shown, although the anchoring part 16 also opens outwards, the angle α (positive angle) at this time is significantly smaller than the angle α without pre-bending treatment. Furthermore, the anchoring part 16 can be pre-bent to control its shape and angle. In this case, before expansion, as... Figure 10a As shown, the anchoring part 16 is folded inward at a certain angle (negative angle), and the anchoring part 16 is pre-processed into an arc-shaped structure (i.e., hook shape) along the length direction. At this time, as... Figure 10b As shown, after expansion, the angle α of the anchoring part 16 extending outward is smaller than the angle α without pre-bending. Furthermore, because the anchoring part 16 is arc-shaped, its effective length is shortened; the effective length is the straight-line length between the head end 162 and the tail end 161 of the anchoring part 16. Further, after expansion, the length L of the anchoring part 16 is preferably 1.0 mm to 2.0 mm, and the angle α of the anchoring part 16 is preferably 20° to 40°, more preferably 30°.

[0092] The form and number of the anchoring parts 16 are not limited; they can be straight, arc-shaped, or bent, and can be in single, double, or multiple rows. The anchoring parts 16 include, but are not limited to, sheet-like shapes.

[0093] Further as Figure 11 As shown, the hollow connecting tube 13 is preferably an elastic structure, such as an elastic cutting tube or a helical spring. When the hollow connecting tube 13 is configured to be elastic, it increases the adaptability of the occluder 10 to different morphologies of the left atrial appendage, particularly enhancing the occlusion performance of left atrial appendages with misaligned body and orifice. That is, by utilizing the elasticity of the hollow connecting tube 13, the misalignment of the fixed disc 11 and the occlusion disc 12 can be achieved. In this embodiment, the hollow connecting tube 13 is a spring and is integrally cut and formed with the fixed disc 11. The number of spring coils is preferably 3 to 5. If the spring is too long, it will increase the overall length of the occluder and also increase the axial distance between the fixed disc 11 and the occlusion disc 12, increasing the risk of the fixed disc 11 being inserted too deeply into the left atrial appendage and causing puncture. If the spring is too short, its flexibility is insufficient. Furthermore, the axial width b of each spring segment 131 can be selected as 0.3 mm to 0.6 mm.

[0094] Furthermore, the hollow connecting tube 13 is preferably connected to the sealing disc 12 by heat fusion, which provides a good connection effect and eliminates the need for the introduction of external materials, thus avoiding safety and complication issues caused by long-term implantation. Further, a connecting portion 132 is provided at the proximal end of the hollow connecting tube 13, the length of which can be 1mm to 2mm, and the distal end of the sealing disc 12 is connected to the connecting portion 132 by heat fusion. More specifically, when connecting the sealing disc 12 to the hollow connecting pipe 13, a liner 40 with a diameter slightly smaller than the inner diameter of the hollow connecting pipe 13 is inserted into the connecting part 132 of the hollow connecting pipe 13, and the distal end of the sealing disc 12 is fitted onto the connecting part 132; the distal end of the sealing disc 12 is heated, the heating temperature can be 150℃~210℃, and the heating time can be 5s~15s, to ensure that the distal end is fully heat-melted without affecting the other parts; during the heat-melting process, the molten sealing disc material (such as molten polylactic acid) enters the hollow connecting pipe 13 through the hole 133 on the connecting part 133 and fills the gap between the liner 40 and the connecting part 132, and after solidification, the sealing disc 12 is firmly connected to the fixing disc 11, and then the liner 40 is removed. The holes 133 on the connecting part 133 penetrate the hollow connecting tube 13 internally and externally. Their shape includes, but is not limited to, circles. Generally, the size of the holes 133 is set according to the inner diameter of the hollow connecting tube 13. Optionally, the diameter d of the holes 133 is 0.5mm to 1.0mm. There are no requirements on the number and distribution of the holes 133 (including gaps).

[0095] like Figure 12As shown, the medical system preferably further includes a limiting device 17 for controlling the shape of the occluder during and after expansion, thereby controlling the expansion size of the occluder. When the occluder 10 expands to a predetermined size, the limiting device 17 locks the fixing plate 11 and the occlusion plate 12 to maintain the occluder in its current shape, thus controlling the expansion size and shape of the occluder. Optionally, the limiting device 17 includes a limiting groove 171 and a limiting buckle 172. When the occluder 10 expands under axial compression, the limiting groove 171 and the limiting buckle 172 gradually approach each other. When the occluder 10 expands to a predetermined size, the limiting buckle 172 engages with the limiting groove 171 to form a fixed position. The present invention does not limit the specific positions of the limiting groove 171 and the limiting buckle 172, as there are multiple implementation methods. For example, in one embodiment, the limiting slot 171 is disposed on the distal fixing member 15. The distal fixing member 15 can be extended into the interior of the fixing plate 11 to form an extension section, and the limiting slot 171 can be disposed on the extension section. Alternatively, the extension section can be connected to the distal fixing member 15. Furthermore, the limiting buckle 172 is disposed at the proximal end of the fixing plate 11, or the limiting buckle 172 is disposed on the hollow connecting tube 13. Similarly, the distal end of the hollow connecting tube 13 can be extended into the interior of the fixing plate 11, and the limiting buckle 172 can be disposed on the extended portion of the hollow connecting tube 13. Additionally, the limiting buckle 172 and the limiting slot 171 can be interchanged. Similarly, the limiting buckle 172 and the limiting slot 171 can also be disposed on the sealing plate 12. Moreover, those skilled in the art should understand that the scope of protection of this invention is not limited to the limiting method achieved by the buckle and slot cooperation in the embodiments. It should be understood that the limiting device 17 can also have other structural forms, and this application applies to all of them.

[0096] Furthermore, all embodiments in this application use a dual-disc external sealing occluder as an example. Those skilled in the art should understand that the scope of protection of this invention is not limited to the dual-disc external sealing occluder in the embodiments. It should be noted that a cage-like occluder can also be implemented in the manner described in the above embodiments. Those skilled in the art should understand that appropriate modifications can be made based on the content disclosed in the above embodiments to achieve the same or similar effects with the cage-like occluder. In simple terms, compared to the dual-disc occluder, the cage-like occluder eliminates the sealing disc 12 and the hollow connecting tube 13. It only requires a proximal fixing member 14 and a distal fixing member 15 at the proximal and distal ends of the fixing disc 11 (cage-like support, woven or cut), respectively. The proximal fixing member 14 is still connected to the external pushing tube 21, and the inner pushing member 22 passes sequentially through the external pushing tube 21, the proximal fixing member 14, and the fixing disc 11 before connecting to the distal fixing member 15. The operation process of the cage-like occluder is basically the same as that of the dual-disc occluder, and will not be described in detail here. Additionally, a membrane may be provided on the sealing disc 12 and / or the fixing disc 11. Furthermore, after the delivery device 20 is removed, the expanded shape of the sealing device can be maintained by its own plastic deformation.

[0097] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A medical system comprising a delivery device and a biodegradable occluder; The occluder includes an occlusion body, a proximal fixation member, a distal fixation member, and an anchoring portion; the proximal end of the occlusion body is connected to the proximal fixation member, and the distal end is connected to the distal fixation member; the anchoring portion is disposed on the occlusion body; the occlusion body includes a biodegradable metal support and the anchoring portion integrally formed with the metal support; the metal support includes multiple circumferentially arranged support rods; at least a portion of the support rods have the anchoring portion cut into their middle sections; the anchoring portion has opposing head and tail ends, the tail end being connected to the metal support, and the head end being a free end; Before the stab cutting, the width of the support rod is 1.1 to 1.3 times the width of the support rod excluding the anchoring part. After the stab cutting, the remaining width of the support rod is 0.85 to 0.95 times the width of the support rod excluding the anchoring part. Before the stab cutting, the width of the support rod is the width of the position on the support rod where the anchoring part needs to be cut. After the stab cutting, the remaining width of the support rod is the width of the middle part of the support rod excluding the anchoring part. The delivery device includes an outer push tube and an inner push member; the outer push tube is detachably connected to the proximal fixation member; the inner push member is detachably connected to the distal fixation member after passing through the outer push tube, the proximal fixation member, and the occlusion body in sequence. The medical system is configured such that the delivery device applies axial pressure to the occluder, causing the occluder body to expand from a collapsed structure to an expanded structure after being compressed, and causing the anchoring portion to open outward as the occluder body expands.

2. The medical system according to claim 1, characterized in that, The anchoring portion is formed by cutting from one side of the middle portion of the support rod.

3. The medical system according to claim 1 or 2, characterized in that, The plug has an initial state and an inflated state; When the plug is in the initial state, the extension direction of the anchoring part forms a negative angle with the positive direction of the axis of the plugging body, and / or the outline of the anchoring part along the length direction is arc-shaped; When the plug is in the expanded state, the extension direction of the anchoring part forms a positive angle with the positive direction of the axis of the plugging body, and / or the outline of the anchoring part along the length direction is arc-shaped.

4. The medical system according to claim 3, characterized in that, The negative angle is -50° to -30°, and the positive angle is 20° to 40°.

5. The medical system according to claim 1 or 2, characterized in that, The inner pusher is a rod or a flexible body.

6. The medical system according to claim 1 or 2, characterized in that, The sealing body also includes a sealing disc woven from biodegradable polymer materials; The metal support and the sealing disc are connected by a hollow connecting pipe; the anchoring part is disposed on the metal support; the distal end of the metal support is connected to the distal fixing member, and the proximal end of the sealing disc is connected to the proximal fixing member.

7. The medical system according to claim 6, characterized in that, The hollow connecting tube has an elastic structure.

8. The medical system according to claim 7, characterized in that, The hollow connecting tube is a spring integrally cut from the metal bracket.

9. The medical system according to claim 6, characterized in that, The hollow connecting tube has a connecting part at its proximal end, and the connecting part has a through hole; the connecting part is thermally fused to the distal end of the sealing disc.

10. The medical system according to claim 6, characterized in that, The plug is configured such that, upon being subjected to axial pressure applied by the conveyor, the metal support and the plugging disc expand simultaneously or sequentially.

11. The medical system according to claim 1 or 2, characterized in that, The plugging device is made of biodegradable metal materials and / or biodegradable polymer materials; The biodegradable metallic material includes at least one of magnesium-based metals, zinc-based metals, and iron-based metals, and the biodegradable polymeric material includes at least one of polylactic acid, polydioxanone, polycaprolactone, polyglycolic acid, and polyglycolic acid.

12. The medical system according to claim 1 or 2, characterized in that, It also includes a limiting device for controlling the expansion size of the plug.

13. The medical system according to claim 12, characterized in that, The limiting device includes a limiting buckle and a limiting slot; when the plug expands to a predetermined size, the limiting slot engages with the limiting buckle.

14. A medical device, characterized in that, Made of biodegradable material, it includes a biodegradable metal support and an anchoring portion connected to the metal support; the metal support includes a plurality of circumferentially arranged support rods; at least a portion of the support rods are cut in the middle to form the anchoring portion; the anchoring portion has opposing head ends and tail ends, the tail ends are connected to the metal support, and the head ends are free ends; Before skewing, the width of the support rod is 1.1 to 1.3 times the width of the support rod excluding the anchoring part. After skewing, the remaining width of the support rod is 0.85 to 0.95 times the width of the support rod excluding the anchoring part. Before skewing, the width of the support rod is the width of the position on the support rod where the anchoring part needs to be cut. After skewing, the remaining width of the support rod is the width of the middle part of the support rod excluding the anchoring part. The anchoring part can be straight, arc-shaped, or bent. When the medical device is subjected to axial pressure, the metal stent expands from a collapsed structure to an expanded structure, and the anchoring portion opens outward as the metal stent expands.

15. The medical device according to claim 14, characterized in that, The anchoring portion is formed by cutting from one side of the middle portion of the support rod.

16. The medical device according to claim 15, characterized in that, The medical device has an initial state and an expanded state; When the medical device is in the initial state, the extension direction of the anchoring part forms a negative angle with the positive direction of the axis of the metal bracket, and / or the outline of the anchoring part along the length direction is arc-shaped; When the medical device is in the expanded state, the extension direction of the anchoring part forms a positive angle with the positive direction of the axis of the metal bracket, and / or the outline of the anchoring part along the length direction is arc-shaped.

17. The medical device according to any one of claims 14-16, characterized in that, The medical device also includes an occlusion disc woven from biodegradable polymer material; the metal stent and the occlusion disc are connected by a hollow connecting tube.

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