Medical system and medical device

Abstract

The present invention relates to a medical system and a medical device. The medical system includes a delivery device and a medical device. The delivery device is configured to deliver the medical device to a target position and control the medical device to radially expand at the target position. The medical device includes a stent, a proximal connector, a distal connector, and a locking device. The proximal connector is connected to the proximal end of the stent, and the distal connector is connected to the distal end of the stent. The locking device includes a first locking member and a second locking member. The first locking member is connected to the proximal connector, and the second locking member is connected to the distal connector. The locking device is configured such that after the stent radially expands to a predetermined size, the first locking member and the second locking member cooperate to lock, so that the stent can still maintain the morphological stability and radial support performance after radial expansion, thereby better meeting the requirements of occlusion treatment.

Description

Technical Field

[0001] The present invention relates to the technical field of body cavity occlusion, and particularly relates to a medical system and a medical device. Background Art

[0002] Atrial fibrillation is the most common persistent arrhythmia clinically and has a risk of inducing ischemic stroke. Data shows that in patients with non-valvular atrial fibrillation, more than 90% of cardioembolic thrombi form in the left atrial appendage. In recent years, studies have shown that occluding the left atrial appendage can effectively prevent the risk of ischemic stroke caused by atrial fibrillation. Since the left atrial appendage occlusion for preventing thromboembolic events in atrial fibrillation was first applied clinically in 2001, its clinical application has developed rapidly at home and abroad and has become an important method for preventing thromboembolic events in patients with atrial fibrillation. At the same time, different types of left atrial appendage occlusion devices have emerged one after another, better meeting the clinical needs and improving the surgical efficacy and safety.

[0003] In the prior art, the occluders used for left atrial appendage occlusion can be basically divided into two categories. One category is the cage-shaped occluder represented by Watchman. Its characteristics are an integrally cut and formed self-expanding frame with anchoring hooks around it, and a porous permeable membrane covering the atrial surface. When in use, it is placed into the left atrial appendage cavity to play a occluding role. The other category is the double-disk occluder represented by LAmbre. Its characteristics are that it is composed of a positioning disk and a occluding disk connected. When in use, the positioning disk is embedded in the left atrial appendage to play a riveting effect and may also play a certain occluding role, and then mainly relies on the occluding disk attached to the left atrial appendage orifice to play a occluding role. Currently, the two types of occluders have a common feature, that is, they are mainly made of nitinol alloy and will accompany the patient for life once implanted into the human body. Since this kind of material cannot be degraded, long-term implantation will cause reactions such as inflammation and coagulation with human tissues, and even cause a certain degree of damage.

[0004] In addition, the following risks may exist: (1) Nitinol is a non-degradable metallic material. Although its biocompatibility has been demonstrated, the long-term risks of permanent implantation still 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 permanently remaining in the heart; (3) There is no clear scientific demonstration for complications such as nickel precipitation and allergies. Additionally, when the left atrial appendage orifice is completely endothelialized, the left atrial appendage occluder loses its function and there is no need to remain in the body. Therefore, an ideal left atrial appendage occluder should provide a temporarily constructed bridge for the endothelialization of the left atrial appendage orifice, be degraded by the body after the endothelialization is completed, so that the occlusion of the left atrial appendage is ultimately completely completed by its own tissue, thereby avoiding long-term complications and potential safety hazards caused by foreign body retention. For this reason, biodegradable left atrial appendage occluders have also been proposed in the prior art. The use of such biodegradable occluders is not widespread mainly because the biodegradable materials do not have shape memory ability and cannot self-expand to a predetermined shape. Even if they are expanded to a predetermined shape by certain means, they cannot maintain the predetermined shape after the external force is removed, thus making it difficult to achieve effective and stable occlusion. Not only that, although the existing non-degradable occluders can self-expand to a predetermined shape, they are prone to deformation under force during long-term use and it is difficult to maintain the morphological stability and radial support performance, affecting the occlusion effect. In addition, occluders in cardiac defects or other environments may also have the same problem. Summary of the Invention

[0005] In view of the problems existing in the prior art, the purpose of the present invention is to provide a medical system and a medical device, which solve the problem that the stent for occluding a body cavity cannot maintain the morphological stability and radial support performance after expanding in the body cavity, so as to achieve effective and stable occlusion and improve the safety of such surgeries.

[0006] To achieve the above purpose, according to the first aspect of the present invention, a medical device is provided, including a stent, a proximal connector, a distal connector, and a locking device; the proximal connector is connected to the proximal end of the stent, and the distal connector is connected to the distal end of the stent;

[0007] The locking device includes a first locking member and a second locking member; the first locking member is connected to the proximal connector, and the second locking member is connected to the distal connector; the locking device is configured such that when the stent radially expands to a predetermined size, the first locking member and the second locking member cooperate to lock.

[0008] Optionally, the locking device is a snap-type locking structure, and one of the first locking member and the second locking member has a snap, and the other has a slot cooperating with the snap.

[0009] Optionally, the first locking member or the second locking member having a card slot further has a guiding portion for guiding the buckle to be inserted into the card slot.

[0010] Optionally, the first locking member or the second locking member having a card slot is a hollow tubular structure, and the card slot is formed inside the hollow tubular structure, and one end of the card slot forms the guiding portion in a flared shape, and the cross-sectional width of the guiding portion is 3.0 mm to 4.0 mm.

[0011] Optionally, the first locking member or the second locking member having a buckle is a hollow rod-shaped structure, and a spherical or ellipsoidal buckle is formed at one end of the hollow rod-shaped structure.

[0012] Optionally, the first locking member has the buckle, and the second locking member has the card slot.

[0013] Optionally, both the second locking member and the first locking member have a channel allowing an inner push rod to pass through, and the diameter of the channel is 1.05 to 1.1 times the diameter of the inner push rod.

[0014] Optionally, the second locking member has an opposite fixed end and a free end;

[0015] The fixed end is connected to the distal connecting member, and the free end is disposed inside the bracket in an initial state and is configured to move relative to the bracket until it is locked with the first locking member under an external force.

[0016] Optionally, the second locking member includes a traction wire and a movable member; one end of the traction wire forms the fixed end, and the other end is connected to the movable member; the movable member has the free end and is configured to be locked with the first locking member.

[0017] Optionally, the second locking member further includes a driving member connected to the movable member, and the driving member is used to pull the movable member to move relative to the bracket.

[0018] Optionally, the locking device is a cable tie type locking structure, and one of the first locking member and the second locking member has a lock hole, and the other has a fishbone-shaped body for cooperating with the lock hole to lock.

[0019] Optionally, the bracket includes a fixed disk and a blocking disk, and the fixed disk and the blocking disk are connected by a hollow connecting pipe; the proximal connecting member is connected to the proximal end of the blocking disk, and the distal connecting member is connected to the distal end of the fixed disk; and / or, the bracket is made of a biodegradable material.

[0020] To achieve the above object, according to the second aspect of the present invention, a medical device is provided, which includes a stent, a proximal connector, a distal connector and a locking device; the proximal connector is connected to the proximal end of the stent, and the distal connector is connected to the distal end of the stent;

[0021] The locking device includes locking wires and a locking slot member in at least two forms; the locking slot member has a slot and is connected to the proximal connector;

[0022] One end of the locking wire is connected to the distal connector, and the other end forms a free end; the free end of the locking wire forms a first form in the free state;

[0023] When the stent radially expands to a predetermined size, the locking wire cooperates with the slot in the first form for locking.

[0024] Optionally, the locking wire is made of a shape memory material, and the free end of the locking wire bends at least one turn in the free state to form the first form.

[0025] Optionally, the diameter of the locking wire is 0.3 mm to 0.6 mm.

[0026] Optionally, the locking slot member is configured as a hollow tubular structure with a distal opening; the inner cavity of the hollow tubular structure and the distal opening form the slot, and the size of the opening is smaller than the size of the inner cavity.

[0027] Optionally, the first form of the locking wire includes a linear part capable of passing through the slot and a specific shape part matching the inner cavity of the hollow tubular structure.

[0028] Optionally, the medical device further includes an inner push rod, the inner push rod has a cavity, the free end of the locking wire is in a second form in the cavity of the inner push rod, and when the stent expands to a predetermined size, the free end of the locking wire disengages from the cavity of the inner push rod and assumes the first form.

[0029] To achieve the above object, according to the third aspect of the present invention, a medical system is provided, which includes a delivery device and a medical device, and the delivery device is used to deliver the medical device to a target position and control the medical device to radially expand at the target position.

[0030] The medical system and medical device provided by the present invention have the following advantages:

[0031] First, the above-mentioned medical device can apply axial pressure to the stent by means of a delivery device to expand the stent to a predetermined shape after it exits the sheath tube, so as to effectively occlude the target site (such as in the environment of patent foramen ovale, heart defect, patent ductus arteriosus or other congenital heart diseases, etc.), ensuring the occlusion effect and improving the surgical efficacy. On the other hand, when the stent expands, it can also drive the anchoring part thereon to open outward and penetrate into the target position for internal fixation, realizing a firm and reliable connection between the stent, especially the degradable stent, and the target position, improving the fixing reliability of the occluding stent, ensuring the safety of occlusion, and ensuring the life safety of the patient; at the same time, when the stent expands radially to a predetermined size, the stent can be locked by a locking device, so that the stent maintains the stability of its shape and radial support performance after expansion, thereby realizing effective and more stable occlusion, improving the occlusion effect, and enhancing the safety of the operation;

[0032] Second, the locking device in the above-mentioned medical device may have a fixed end and a free end. The free end is arranged inside the stent in the initial state and moves relative to the stent under the action of an external force until it locks with the first locking member; this structure can ensure the fixed axial length of the stent while enabling the stent to have good axial bending performance to adapt to the body cavity where the main body and the mouth are not coaxial;

[0033] Third, the locking device in the above-mentioned medical device may adopt a zip-tie type locking structure. This structure can not only ensure the axial bendability after locking, but also realize the adjustable locking length of the degradable stent, making the use of the medical device more flexible, convenient, and having better adaptability to body cavities with different shapes and sizes;

[0034] Fourth, when the locking device in the above-mentioned medical device adopts a snap-type locking structure, it is preferable to use a spherical or ellipsoidal snap for locking, so that the medical device has good axial bending ability and increases the occlusion performance of the device for body cavities with different shapes, especially body cavities where the body and the mouth are not coaxial;

[0035] Fifth, when the locking device in the above-mentioned medical device adopts a snap-type locking structure, it is preferable to use a locking wire for locking. On the one hand, it can realize the locking by the doctor in the blind operation state, avoiding the situation that it cannot be locked due to misalignment, reducing the difficulty of surgical operation. On the other hand, it can also ensure that the occluder still has axial flexible bending ability after locking, increasing the occlusion performance of the device for body cavities with different shapes, especially body cavities where the body and the mouth are not coaxial. On the third hand, the whole locking device is small in size, which is more conducive to the occluder being received into the delivery sheath tube, and has good recovery performance. Moreover, the whole locking device has a simple structure, high reliability, and is convenient to operate. Description of the Drawings

[0036] Figure 1Schematic three-dimensional structure diagram of the occluder in the preferred embodiment of the present invention, where the occluder has been pushed out of the delivery sheath and radially expanded and axially locked by pushing;

[0037] Figure 2a Schematic diagram showing the locking of the occluder through a snap structure in the preferred embodiment of the present invention;

[0038] Figure 2b Schematic diagram showing the locking of the occluder through a cable structure in the preferred embodiment of the present invention;

[0039] Figure 2c Schematic diagram showing the locking of the occluder through a cable tie structure in the preferred embodiment of the present invention;

[0040] Figure 3a Schematic three-dimensional structure diagram of the occluder with a guiding part in the locking device in the preferred embodiment of the present invention, where the occluder has been pushed out of the delivery sheath and radially expanded and axially locked by pushing;

[0041] Figure 3b Schematic structure diagram of the occluder with a guiding part in the locking device and the delivery device assembled therewith in the preferred embodiment of the present invention;

[0042] Figure 3c Partial schematic diagram showing the locking of the occluder through a ball head snap in the preferred embodiment of the present invention;

[0043] Figure 4a Schematic diagram before the release of the locking wire when the occluder is locked through the locking wire in the preferred embodiment of the present invention;

[0044] Figure 4b Schematic diagram after the release of the locking wire when the occluder is locked through the locking wire in the preferred embodiment of the present invention;

[0045] Figure 4c Schematic diagram with one loop in the free end of the locking wire in the preferred embodiment of the present invention;

[0046] Figure 4d Schematic diagram with three loops in the free end of the locking wire in the preferred embodiment of the present invention;

[0047] Figure 5 Schematic diagram of the state of the occluder before expansion after release in the preferred embodiment of the present invention;

[0048] Figure 6 Schematic diagram of the state of the occluder being compressed and expanded and two locking members gradually approaching in the preferred embodiment of the present invention;

[0049] Figure 7Schematic diagram of the state of the occluder after pressure expansion and locking of two locking members in a preferred embodiment of the present invention;

[0050] Figure 8 Schematic diagram of the state of the occluder after pressure expansion and locking of two locking members in a preferred embodiment of the present invention, with the outer delivery tube and the inner delivery rod removed.

[0051] The reference numerals are explained as follows:

[0052] 10 - Occluder; 11 - Fixed disk; 12 - Occluding disk; 13 - Proximal connecting member; 14 - Distal connecting member; 15 - Hollow connecting tube; 16 - Anchoring portion;

[0053] 20 - Delivery device; 21 - Outer delivery tube; 22 - Inner delivery rod;

[0054] 200 - Delivery sheath;

[0055] 100 - Locking device;

[0056] 101 - First locking member; 1011 - Buckle; 1012 - Locking groove member; 101a - Fishbone-shaped body;

[0057] 102 - Second locking member; 1021 - Guide portion; 1022 - Groove; 1023 - Locking wire; 1024 - Free end of the locking wire; 103 - Traction wire; 104 - Movable member; 102a - Lock hole; 23 - Driving member;

[0058] S - Left atrial appendage. Detailed implementation manners

[0059] 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 accompanying drawings are in very simplified forms and use non-precise scales, only for the purpose of facilitating and clearly assisting in explaining the objectives of the embodiments of the present invention.

[0060] It should be noted that the structures, scales, sizes, etc. shown in the drawings of this specification are only used to cooperate with the content disclosed in the specification for those skilled in the art to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention. Therefore, they do not have technical essence. Any modification of the structure, change of the proportional relationship, or adjustment of the size, without affecting the effects that the present invention can produce and the objectives that can be achieved, should still fall within the scope covered by the technical content disclosed in the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle", and "one" used in this specification are only for the convenience of clear description and are not used to limit the scope for the implementation of the present invention. The change or adjustment of their relative relationships, without substantial change in the technical content, should also be regarded as the scope for the implementation of the present invention.

[0061] In this article, the proximal end refers to the end of the medical device close to the surgical operator, the distal end refers to the end of the medical device far from the surgical operator, and the radial direction refers to the direction perpendicular to the axis of the medical device.

[0062] To solve the technical problems raised in the background art, the present invention proposes a novel medical device that can maintain the stability of the stent shape and radial support performance after the radial expansion of the occluding stent, so as to better meet the needs of occlusive treatment. Preferably, the occluding stent can be degraded, enabling it to achieve controlled expansion to a predetermined shape at the target position without the ability of shape memory, and at the same time, it can maintain the stability of its own shape and radial support performance after removing the external force. It should be understood that the medical device provided by the present invention can be applied to the left atrial appendage, and can also be applied to environments such as patent foramen ovale, cardiac defect, patent ductus arteriosus, or other congenital heart diseases.

[0063] In addition, the present invention also proposes a medical system, including a medical device and a delivery device. The delivery device is used to deliver the medical device to the target position in the body, control the medical device to radially expand at the target position, and also control the medical device to achieve axial locking.

[0064] In the following, in order to illustrate the technical solution provided by the present invention, a left atrial appendage occluder is used as an applicable example. The occluder provided by the present invention can be degradable or non-degradable, preferably degradable. When the occluder is non-degradable, it avoids the problem that the occluder is deformed under force during long-term implantation and is difficult to maintain the stability of the shape and radial support performance, and improves the occlusive performance of the non-degradable occluder. When the occluder is degradable, it avoids the long-term complications and safety hazards caused by long-term implantation of the occluder. Moreover, in the case where the material does not have the ability of shape memory, it can still achieve the purpose of expanding the occluder to a predetermined shape, ensuring the occlusive performance of the left atrial appendage, and can also achieve a firm and reliable connection between the occluder and the left atrial appendage, improving the reliability of the occluder fixation, enhancing the safety of the occluder, and ensuring the life safety of the patient. In particular, it can maintain the stability of the occluder shape and radial support performance after removing the external force. After the occluder of the present invention is delivered to the target position in the body by the delivery device and pushed out of the delivery sheath, thereafter, by pushing or pulling the occluder with the delivery device, the occluder is axially stressed and controllably radially expanded until the occluder expands to a predetermined shape. Moreover, when the occluder expands, it can also drive the anchoring part thereon to open outward and penetrate into the inner wall of the left atrial appendage, forming a reliable connection between the occluder and the left atrial appendage.

[0065] It should be understood that the occluder in this embodiment can be a cage-shaped inner plug occluder or a double-disk occluder, and the double-disk occluder can be used for external occlusion or internal occlusion. It should also be known that for the double-disk occluder, in actual use, the fixing disk and the occluding disk can be integrally inserted into the inner cavity of the left atrial appendage to achieve occlusion, or only the fixing disk can be inserted into the inner cavity of the left atrial appendage, and the occluding disk can be occluded at the outer mouth, or in the case of atrial septal defect, the fixing disk and the occluding disk can be occluded on both sides of the atrial septum.

[0066] In this article, although a degradable occluder is used as an example to illustrate that a medical device can easily maintain the morphological stability and radial support performance after radial expansion through a locking device, the degradable occluder is not used as a limitation to the present invention. The medical device of the present invention can also be non-degradable, and the following embodiments provided for the degradable occluder are also applicable to the non-degradable occluder.

[0067] Furthermore, the material of the occluder is a degradable polymer material and / or a degradable metal material. In some embodiments, the occluder is a cage-shaped inner plug type. At this time, the occluder only includes one fixing disk, and the fixing disk can be cut or woven, preferably cut from a degradable metal pipe. In other embodiments, the occluder is a double-disk type. At this time, in addition to the fixing disk, the occluder further includes an occluding disk. The occluding disk and the fixing disk are connected by a hollow connecting pipe, and the processing methods of the fixing disk and the occluding disk can be the same or different. Preferably, the fixing disk is cut from a degradable metal pipe, and the occluding disk can be cut or woven. Preferably, the occluding disk is woven from a degradable polymer material and has good flexibility.

[0068] The degradable metal materials used in the occluder of this embodiment include but are not limited to magnesium-based metals (such as magnesium alloys), zinc-based metals (zinc alloys), and iron-based metals (iron alloys). In addition, the degradable polymer materials include but are not limited to polylactic acid, poly-p-dioxanone, polycaprolactone, polyglycolide, and poly(lactide-co-glycolide). It should also be understood that one material or a combination of multiple materials in the degradable metal materials can be selected to prepare the occluder, or one material or a combination of multiple materials in the degradable polymer materials can be selected to prepare the occluder. Moreover, the occluder as a whole can only use degradable metal materials, or can only use degradable polymer materials as a whole, or can also use degradable metal materials and degradable polymer materials at the same time.

[0069] In addition, whether it is a double-disk type or a cage-shaped inner plug type, and whether it is biodegradable or non-biodegradable, the occluder provided in this embodiment should include a stent, a proximal connector, and a distal connector. The stent constitutes the main body of the occluder. The proximal end of the stent is connected to the proximal connector, and the distal end is connected to the distal connector. When the occluder is of the cage-shaped inner plug type, the stent only includes a fixing disk, and the proximal and distal ends of the fixing disk are respectively connected to the proximal connector and the distal connector; when the occluder is of the double-disk type, the stent includes a blocking disk and a fixing disk, wherein the distal end of the fixing disk is connected to the distal connector, and the proximal end of the blocking disk is connected to the proximal connector.

[0070] Furthermore, the delivery device for delivering the occluder includes an outer push tube, which is used for detachably connecting with the proximal connector. In some embodiments, the delivery device further includes an inner push rod, which is used for passing through the outer push tube, the proximal connector, and the stent and then detachably connecting with the distal connector. During actual operation, when the occluder is delivered to the target position by the delivery device and pushed out from the delivery sheath, as long as one of the outer push tube and the inner push rod remains stationary and the other moves in a predetermined direction (the predetermined direction is the direction of moving towards the proximal or distal end of the occluder), the occluder can be expanded from the collapsed structure to the expanded structure under the action of the axial pressure of the delivery device. And when the occluder expands to a predetermined size, the locking device on the occluder is triggered to be in the locked position so that the occluder maintains the predetermined size and shape. Moreover, during the expansion process of the occluder, the originally retracted anchoring part gradually opens outwards and finally pierces into the inner wall of the left atrial appendage to ensure a firm connection between the occluder and the left atrial appendage. In other embodiments, a driving member (such as a rope) is used instead of the inner push rod, and by pulling the driving member proximally, the occluder is driven to expand radially.

[0071] Moreover, the occluder further includes a locking device for axially locking the occluder when the occluder expands to a predetermined shape and size. The locking device specifically includes a first locking member and a second locking member; the first locking member is connected to the proximal connector, and the second locking member is connected to the distal connector; during the expansion process of the stent, the first locking member and the second locking member move towards each other and gradually approach until the two cooperate and lock.

[0072] Next, to make the above objects, features, and advantages of the present invention more apparent and understandable, the preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings. And for the sake of simplicity, in the following description, it is assumed that the occluder is a biodegradable double-disk occluder. Those skilled in the art should be able to modify the following description and apply the description to the case of a cage-shaped inner plug occluder and the case of a non-biodegradable occluder after making appropriate modifications in details. At the same time, for the purpose of explanation, in the following description, it is assumed that the occluder is a left atrial appendage occluder. Those skilled in the art should be able to modify the following description and apply the description to the case where it is not a left atrial appendage occluder after making appropriate modifications in details.

[0073] Figure 1 It is a schematic three-dimensional structure diagram of the occluder of the preferred embodiment of the present invention. As Figure 1 shown, this embodiment relates to an occluder 10, including a fixing disk 11 and a blocking disk 12. Preferably, the fixing disk 11 is cut from a biodegradable metal pipe, so that the fixing disk 11 has good strength and good shaping ability, and the blocking effect is good. Preferably, the blocking disk 12 is cut or woven from a biodegradable polymer material, making the blocking disk 12 softer than the fixing disk 11, so that the occluder 10 has good compliance. In another embodiment, there may be only the fixing disk 11 without the blocking disk 12. Preferably, the materials and processing techniques of the fixing disk 11 and the blocking disk 12 are different to enhance the fixing and blocking performance of the occluder.

[0074] In this embodiment, the blocking disk 12 is woven from a biodegradable polymer material, which has the characteristics of softness and good compliance, is conducive to enhancing the fitting of the blocking disk 12 with the orifice of the left atrial appendage, and improving the effectiveness of blocking. At the same time, the soft blocking disk 12 is conducive to reducing or even eliminating the damage to the orifice of the left atrial appendage and the nearby tissues, and improving the safety of the occluder. The material of the blocking disk 12 includes but is not limited to polylactic acid. At the same time, the fixing disk 11 is made of a biodegradable metal material with good strength and cut, which is conducive to improving the anchoring performance of the occluder in the left atrial appendage and preventing it from falling off from the left atrial appendage. The material of the fixing disk 11 includes but is not limited to magnesium alloy.

[0075] The occluder 10 further includes a proximal connector 13 and a distal connector 14. The proximal connector 13 is connected to the proximal end of the occluding disc 12, and the distal connector 14 is connected to the distal end of the fixing disc 11. In another embodiment, there may be only the fixing disc 11 without the occluding disc 12. At this time, the proximal connector 13 is connected to the proximal end of the fixing disc 12, and the distal connector 14 is connected to the distal end of the fixing disc 11. The proximal connector 13 and the occluding disc 12 are integrally formed or separately connected. The distal connector 14 and the fixing disc 11 are integrally formed or separately connected. Or when there is no occluding disc 12, the proximal connector 13 and the distal connector 14 are integrally formed or separately connected to the fixing disc 11.

[0076] The occluder 10 further includes a locking device 100. For example, Figure 1 a locking device 100 is provided at the position of the rectangular frame indicated by A1. The locking device 100 specifically includes a first locking member 101 and a second locking member 102. The first locking member 101 is connected to the proximal connector 13, and the two can be integrally formed or separately connected; the second locking member 102 is connected to the distal connector 14, and the two can be integrally formed or separately connected. The function of the locking device 100 is to axially lock the occluder 10 after the occluder 10 expands to a predetermined shape, so that the occluder 10 maintains the stability of its shape and the radial supporting force after the external acting force is removed. Figure 1 That is, the state where the occluder 10 is locked after being pushed out of the delivery sheath 200 (see Figure 2a ). Here, it should be understood that if the occluder 10 is degradable, it is expanded by an external acting force after it is out of the sheath. For example, in this embodiment, the delivery device is used to control the expansion of the degradable occluder; if the occluder 10 is non-degradable, the occluder 10 can expand autonomously by its own elasticity after being out of the sheath. At this time, the occluder only needs to be pushed out of the sheath by the delivery device without the delivery device controlling the expansion of the occluder.

[0077] Further referring to Figures 5 to 8 , the operation process of the occluder 10 in this embodiment will be further described.

[0078] As Figure 5 shown, when the occluder 10 is delivered to the target position (such as the fixing disc 11 is located in the left atrial appendage S, and the occluding disc 12 is located outside the left atrial appendage S and corresponds to the orifice of the left atrial appendage) and pushed out of the delivery sheath 200, before expansion, the occluder 10 can be moved or rotated by a delivery device (such as Figure 3b the outer push tube 21 or the inner push rod 22 in

[0079] As Figure 6As shown, after the surgical operator adjusts the position and angle of the occluder 10, the occluder 10 is compressed (i.e., axially compressed by the left and right arrows) from the collapsed state to the expanded state (i.e., radially expanded by the up and down arrows) by the delivery device (such as keeping the inner pusher rod 22 stationary and moving the outer delivery tube 21 distally, or keeping the outer delivery tube 21 stationary and moving the inner pusher rod 22 proximally). Here, it should be understood that during the process of pushing and expanding, when the occluding disc 12 is made of a relatively soft material such as polylactic acid, the occluding disc 12 can be the first to complete the expansion and return to the predetermined shape, and then the fixing disc 11 expands, and during the expansion of the occluder 10, the first locking member 101 and the second locking member 102 of the locking device 100 gradually approach but have not yet been locked.

[0080] As Figure 7 shown, when the occluder 10 continues to expand under the push of the delivery device 20, and when the occluder 10 expands to the predetermined shape, the first locking member 101 and the second locking member 102 cooperate to lock, thus realizing the axial locking of the occluder 10, so that the occluder 10 remains in the current form after the axial pressure is removed, thereby ensuring the stability of the shape and the reliability of the function of the occluder 10.

[0081] As Figure 8 shown, when the occluder 10 is successfully released, expanded and locked, the surgical operator withdraws the delivery device 20 from the body (the inner pusher rod 22 and the outer delivery tube 21 are successively withdrawn from the body), and the occlusion surgery is completed.

[0082] In addition, it should also be known that during the expansion of the occluder 10, the anchoring portion 16 on the fixing disc 11 opens in a direction away from the axis of the fixing disc 11 and gradually penetrates into the inner wall of the left atrial appendage, so that the occluder 10 forms a firm and reliable connection with the left atrial appendage.

[0083] More specifically, the occluder 10 has an initial state in which the occluder 10 is not expanded, as Figure 5 shown, it is axially longer and has a small radial dimension, that is, the occluder 10 is in a collapsed structure at this time; the occluder 10 also has an expanded state, at this time, the occluder 10 is axially compressed and radially expanded, as Figures 6 to 8As shown. In actual application, during the expansion process of the occluder 10, the originally retracted anchoring portion 16 also gradually opens outward and finally pierces into the inner wall of the left atrial appendage; generally, when the occluder 10 radially expands to a predetermined size and ensures a firm connection between the occluder 10 and the left atrial appendage, the delivery device 20 can be withdrawn to complete the occlusion of the left atrial appendage. It should be understood that the traditional non-degradable anchoring portion 16 has a shape memory function and can open outward autonomously, while the anchoring portion 16 in this embodiment cannot open outward autonomously if it is degradable. Therefore, it is necessary to rely on the expansion of the occluder 10 to prompt the anchoring portion 16 to open outward, so that the anchoring portion 16 pierces into the inner wall of the left atrial appendage. Further, since the anchor spurs (the anchor spurs are the anchoring portion 16) are formed by cutting on the support rods of the fixing plate 12, the width of the support rods at this location (i.e., the support rods forming the anchor spurs) will decrease, so it is more likely to bend compared to other parts. Therefore, when the occluder 10 changes from the collapsed state to the expanded or dilated state, it will naturally expand in the area where the anchoring portion 16 is located.

[0084] It should also be known that for the double-disk occluder 10, the expansion sequence can actually be adjusted. For example, the occlusion disk 12 can be expanded first and then the fixing disk 11, or the fixing disk 11 can be expanded first and then the occlusion disk 12, or the fixing disk 11 and the occlusion disk 12 can be expanded simultaneously. These methods can all be controlled by factors such as materials and dimensions. For example, when the fixing disk 11 is softer than the occlusion disk 12, after the occluder 10 is pushed out of the sheath tube and under axial compression, the fixing disk 11 expands first. When the fixing disk 11 finishes expanding, the occlusion disk 12 starts to expand; if the occlusion disk 12 is softer than the fixing disk 11, after the occluder 10 is pushed out of the sheath tube and under axial compression, the occlusion disk 12 expands first. When the occlusion disk 12 finishes expanding, the fixing disk 11 starts to expand; if the softness of the occlusion disk 12 and the fixing disk 11 is equivalent, the two can expand simultaneously, that is, after being pushed out of the sheath tube and under axial compression, the occlusion disk 12 and the fixing disk 11 start to expand simultaneously. Here, by adjusting the expansion sequence, it is convenient for doctors to perform surgery.

[0085] Further, the locking device 100 can adjust different locking structure forms according to different requirements, such as adopting a snap-type locking structure, a cable-type locking structure, a zip-tie type locking structure, etc. Through the locking of the first locking member 101 and the second locking member 102, the occluder 10 is kept in an axially locked state and fixed at the left atrial appendage.

[0086] In one implementation, such as Figure 2aAs shown, the locking device 100 adopts a snap - type locking structure. In this locking method, one of the first locking member 101 and the second locking member 102 has a snap, and the other has a slot. Through the locking of the slot and the snap, the plugging device 10 is axially locked. In this embodiment, the first locking member 101 has a snap, and the second locking member 102 has a slot. Further, the first locking member 101 is a hollow tubular structure and forms a snap at the distal end of the hollow tubular structure. The snap can be triangular or other suitable shapes, and the number of snaps can be one or more. Further, the second locking member 102 is a hollow tubular structure, and a slot is provided on the inner wall of the proximal end of the hollow tubular structure. The number of slots corresponds to the number of snaps. Using this structure can achieve the locking of the plugging device 10 at a certain axial length, and the locking length of the plugging device 10 is not adjustable.

[0087] In another embodiment, the second locking member 102 has an opposite fixed end and free end. The fixed end is connected to the distal connecting member 14, and the free end is arranged inside the stent in the initial state and is configured to move relative to the stent until it locks with the first locking member 101 under the action of an external force. Preferably, the first locking member 101 is the proximal connecting member 13. Further, as Figure 2bAs shown, the second locking member 102 includes a traction wire 103 and a movable member 104. One end of the traction wire 103 forms a fixed end, and the other end is connected to the movable member 104. The movable member 104 has a free end and is configured to lock with the first locking member 101, preferably with the proximal connecting member 13. Further, the second locking member 102 further includes a driving member 23. The driving member 23 is connected to the movable member 104, and the driving member 23 is used to drive the movable member 104 to move relative to the stent, such as relative to the fixed disk 11. Preferably, the driving member 23 has a handle at the proximal end. In some embodiments, the driving member 23 is a rope, and the movable member 104 is provided with a perforation for threading the rope. There is no requirement for the setting method of the perforation, and the number of perforations can be one or more. The rope and the perforation can be relatively fixed or relatively movable for release. In other embodiments, the movable member 104 is threadedly connected to the driving member 23. More specifically, in the initial state, the movable member 104 is located inside the occluder 10 (i.e., as shown by the dotted line). After the occluder 10 is pushed out of the delivery sheath 200, the outer push tube 21 is kept stationary, and the driving member 23 is pulled proximally, so that the driving member 23 pulls the movable member 104 to move proximally, thereby pulling the distal connecting member 14 to move proximally as well, so as to expand the occluder 10. And as the movable member 104 passes through and further exits the proximal connecting member 13 under the continuous pulling of the driving member 23, the movable member 104 locks with the proximal connecting member 13, that is, the movable member 104 realizes the locking by abutting against the proximal end face of the proximal connecting member 13 with its own size. Adopting such a structure can ensure that the axial length of the occluder is fixed while still having good axial bending performance to adapt to the left atrial appendage with different axes between the degradable stent and the orifice of the left atrial appendage.

[0088] In another embodiment, as Figure 2c shown, the locking device 100 adopts a cable tie type locking structure. In this locking method, the locking device 100 includes a fishbone cable tie. Specifically, the first locking member 101 includes a fishbone-shaped body 101a, and the second locking member 102 includes a locking hole 102a that is snap-fitted with the fishbone-shaped body 101a. The fishbone-shaped body 101a is inserted into the locking hole 102a for locking. Adopting such a structure can not only ensure the axial bendability of the occluder 10 after locking, but also realize the adjustable locking length of the occluder, so that the use of the occluder is more flexible and the adaptability to the left atrial appendages with different morphological sizes is better. In other embodiments, the second locking member 102 includes a fishbone-shaped body 101a, and the first locking member 101 includes a locking hole 102a.

[0089] It should be understood that the above locking methods are only examples and do not constitute a limitation on the structure of the locking device 100 of the present invention.

[0090] Furthermore, the locking device 100 is made of degradable or non-degradable materials. The degradable polymer materials for preparing the locking device 100 include, but are not limited to, polylactic acid, poly-p-dioxanone, polycaprolactone, polyglycolide, poly(lactide-co-glycolide), etc. The degradable metal materials for preparing the locking device 100 include, but are not limited to, degradable magnesium alloys, zinc alloys, pure iron, etc. In addition, the locking device 100 can be integrally formed or separately connected with a degradable stent. In this embodiment, for example, the second locking member 102 is integrally formed or separately connected with the distal connecting member 14, and the first locking member 101 is integrally formed or separately connected with the proximal connecting member 13. Additionally, the object to be locked can be a certain easily deformable part of the single locking occluder, such as the fixing disc 11 or the occluding disc 12, or the fixing disc 11 and the occluding disc 12 can be locked simultaneously.

[0091] Furthermore, considering that during the operation, the surgeon cannot accurately observe the movement of the locking device 100, which may cause the first locking member 101 and the second locking member 102 to be misaligned and unable to be locked, a guiding portion 1021 ( Figure 3c ) is added to the locking member provided with the card slot. The guiding portion 1021 is used to guide the buckle to be smoothly engaged with the card slot.

[0092] Furthermore, as Figures 3a to 3cAs shown, the second locking member 102 preferably has a card slot 1022, and the first locking member 101 has a buckle 1011. Further, the first locking member 101 is a hollow rod-shaped structure, and the second locking member 102 is a hollow tubular structure. Both locking members form a channel inside to allow the inner push rod 22 to pass through. More preferably, the second locking member 102 has a horn-shaped or flared guiding portion 1021, and the guiding portion 1021 is located at the proximal end of the card slot 1022. The maximum cross-sectional width (preferably the maximum outer diameter) of the guiding portion 1021 should not be too large or too small, and a value of 3 mm to 4 mm is more preferable; if the diameter is too small, it cannot play a good guiding role; if the diameter is too large, the occluder 10 cannot be retracted into the delivery sheath 200. The shape of the buckle 1011 in this embodiment is not limited. Preferably, the first locking member 101 has a spherical or ellipsoidal buckle 1011 to ensure that the first locking member 101 can be inserted into the second locking member 102 from all directions, thereby ensuring smooth locking in the blind operation environment of the surgery and further reducing the difficulty of the surgical operation. In this embodiment, when the spherical or ellipsoidal or other suitable-shaped buckle 1011 is inserted into the card slot 1022, since the card slot opening is slightly smaller than the buckle 1011, the two are mutually extruded, and at this time, with the help of the elasticity of the material under an external force, the buckle 1011 is inserted into the card slot 1022. After the buckle 1011 enters the card slot 1022, the card slot opening returns to its original size, making the buckle 1011 no longer able to easily escape, achieving locking. When the locking is completed, a structure similar to a joint of a bone is formed to ensure that the occluder has good axial flexible bending ability after locking, so as to increase the occluding performance of the occluder for different-shaped auricles, especially the left auricle with different axes of the body and the mouth portion.

[0093] Continue to refer to Figure 3b, this embodiment provides a conveying device 20, including an outer pushing tube 21, and the outer pushing tube 21 is used to be detachably connected to the proximal connecting piece 13. In some embodiments, the conveying device 20 further includes an inner pushing rod 22, and the inner pushing rod 22 is used to be detachably connected to the distal connecting piece 14. The inner pushing rod 22 passes through the outer pushing tube 21 and penetrates into the occluder main body to be connected to the distal end 14, and is used to cooperate with the outer pushing tube 21 when expanding to provide an axial pressure for the occluder 10, so as to achieve the purpose of radially expanding the occluder 10. The inner pushing rod 22 can be a rod capable of being axially compressed, or a flexible body capable of being axially tensioned (such as a wire, rope or thread, etc., preferably a guide wire). Relatively speaking, the flexible body has a smaller size, which is beneficial to reducing the size of the conveying device 20. The flexible body can be detachably connected to the distal end of the occluder 10 in a perforating manner. The perforations can be one or more, and the axis of the perforation can be parallel or perpendicular to the axis of the fixing plate 11. In some other embodiments, the conveying device 20 further includes the aforementioned driving member 23 and does not include the inner pushing rod 22. The driving member 23 is used to cooperate with the outer pushing tube 21 when expanding to provide an axial pressure for the occluder 10, so as to achieve the purpose of radially expanding the occluder 10.

[0094] The connection method between the outer pushing tube 21 and the proximal connecting piece 13 can be adjusted according to actual needs, such as selecting one or a combination of mechanical connections such as threads, buckles, clamping, perforations, or other non-mechanical connection methods. Similarly, the connection method between the inner pushing rod 22 and the distal connecting piece 14 can be adjusted according to actual needs, and the detachable connection can be one or a combination of mechanical connections such as threads, buckles, clamping, perforations, or other non-mechanical connection methods. In addition, the inner pushing rod 22 and the outer pushing tube 21 can choose the same or different connection methods. For example, when the outer pushing tube 21 selects a threaded connection, the inner pushing rod 22 can select a threaded connection or other connection methods. There are no special requirements for this in the present invention. In this embodiment, the outer pushing tube 21 is threadedly connected to the proximal connecting piece 13, and the inner pushing rod 22 is threadedly connected to the distal connecting piece 14.

[0095] The occluder 10 further includes a hollow connecting tube 15 and an anchoring portion 16. The fixing plate 11 and the occluding plate 12 are connected through the hollow connecting tube 15. The hollow connecting tube 15 has an axially penetrating inner cavity, and is preferably integrally formed with the fixing plate 11, such as integrally cut, which is convenient for simplifying the structure and the processing technology. The anchoring portion 16 is connected to the fixing plate 11, and preferably the anchoring portion 16 is integrally cut with the fixing plate 11 or the anchoring portion 16 is detachably connected to the fixing plate 11.

[0096] Taking the inner pushing rod 22 as an example, such as Figures 3a to 3cAs shown, the inner pushing rod 22 sequentially passes through the outer pushing tube 21, the proximal connecting member 13, the first locking member 101, the hollow connecting tube 15, and the second locking member 102 and then is connected to the distal connecting member 14. At the same time, the interiors of the first locking member 101 and the second locking member 102 are both hollow structures to form channels, and the diameters of the channels are slightly larger than the diameter of the inner pushing rod 22, preferably 1.05 to 1.1 times the diameter of the inner pushing rod 22, to allow the inner pushing rod 22 to pass through the locking device 100; this can not only ensure the smooth sliding of the locking device 100 on the inner pushing rod 22, but also ensure that the first locking member 101 and the second locking member 102 do not have serious misalignment when approaching each other, reducing the difficulty of surgical operation.

[0097] Further in other embodiments, please refer to Figure 4a and Figure 4b , the second locking member 102 preferably includes a locking wire 1023, the first locking member 101 includes a locking groove member 1012, and the locking groove member 1012 has a groove. The locking wire 1023 has at least two forms, namely the first form and the second form; when the locking wire 1023 is in the first form, its free end 1024 is in a free state and cooperates with the groove for locking; when the locking wire 1023 is in the second form, its free end 1024 is not locked with the groove. Preferably, the locking wire 1023 is made of a shape memory material, and the shape memory material includes but is not limited to nickel-titanium alloy, to utilize the shape memory ability of the locking wire 1023 to restore the predetermined shape after the restraint is released. The "free state" here refers to the situation when the locking wire 1023 is not subjected to external force. When the free end 1024 of the locking wire 1023 is in the first form, the free end 1024 of the locking wire is similar to a buckle. Thus, after the stent expands radially to a predetermined size, the locking wire 1023 cooperates with the locking groove member 1012 in the first form for locking.

[0098] More specifically, one end of the locking wire 1023 is connected to the distal connecting member 14, and the other end is the free end 1024 and is configured to form the first form in the free state. Further, the locking wire 1023 passes through the cavity of the inner pushing rod 22. Limited by the cavity size of the inner pushing rod 22, the locking wire 1023 is in the second form in the cavity of the inner pushing rod 22, and this second form can be a straight state ( Figure 4a ); when the expansion of the occluder 10 is completed and the inner pushing rod 22 is withdrawn, the locking wire 1023 is released from the cavity of the inner pushing rod 22, and its free end 1024 is restored to the first form. The free end 1024 in the first form has a bent portion; and since the size of the groove of the locking groove member 1012 is smaller than the size of the free end 1024 of the locking wire 1023 in the first form, the free end 1024 of the locking wire cannot escape from the groove of the locking groove member 1012, forming a lock ( Figure 4b)。On one hand, the locking device 100 of this structure can achieve locking in the blind operation state by the doctor, and it is less likely to occur the situation that it cannot be locked due to dislocation. On the other hand, it can also ensure that the occluder still has the ability to flex axially after locking. On the third hand, the size of the entire locking device is small, which is more conducive to the occluder 10 being received into the delivery sheath 200.

[0099] Further considering that the locking wire 1023 should not come out again after locking, the present invention has certain requirements for the strength of the locking wire 1023. At the same time, it is necessary to take into account the size and the formability of the locking wire. Therefore, the diameter of the locking wire 1023 should not be too thin or too thick, and 0.3 mm - 0.6 mm is preferred. It should be noted that the diameter (thickness) of the locking wire affects the deformation ability of the locking wire. When the card slot catches the free end 1024 in the first form, the deformation ability of the free end 1024 must be less than the locking ability, that is, the deformation force of the free end should be greater than the locking force, otherwise the locking wire 1023 will disengage from the card slot. In addition, to increase the locking strength, the number of turns of the free end 1024 of the locking wire 1023 bent in the free state can be appropriately increased or the bent shape can be changed. Preferably, the free end 1024 of the locking wire is bent at least one turn in the free state, and the preferred number of turns of bending is 1 - 4 turns, that is Figure 4c or Figure 4d as shown. In addition, the present invention does not limit the material of the locking wire 1023, for example, including but not limited to nickel-titanium alloy. The present invention does not limit the shape of the free end 1024 of the locking wire in the free state, such as it can be a spiral shape, a vortex shape, a spherical shape, a hexahedron shape or other randomly distributed shapes. Further, the locking card slot member 1012 is configured as a hollow tubular structure with a distal opening, so that the inner cavity and the distal opening of the hollow tubular structure of the locking card slot member 1012 form a card slot, and the size of the distal opening of the locking card slot member 1012 is smaller than the size of its inner cavity to increase the reliability of locking.

[0100] Further, the first form of the locking wire 1023 includes a linear part capable of passing through the card slot of the locking card slot member 1012 and a specific shape part matching the inner cavity of the locking card slot member 1012. It should be understood that matching the hollow tubular structure of the locking card slot member 1012 means that the form of the locking wire 1023 is the same as the contour of the inner cavity structure. In this way, the locking wire 1023 can just be stuck at the distal opening of the hollow tube and is not easy to fall off. Matching the hollow tubular structure of the locking card slot member 1012 can also mean that the free end 1024 of the locking wire 1023 can be multiple loops, and the diameter of the loops is just the same as the diameter of the inner cavity of the hollow tubular structure, thereby increasing the friction force of the loops in the inner cavity of the hollow tubular structure, enhancing the locking force and making it not easy to fall off. In addition, the locking wire 1023 can be formed by winding single-strand or multi-strand wires. Preferably, the number of bending loops of the free end 1024 of the locking wire 1023 in the free state can be one or more, and more than one means at least two. When the number of bending loops of the free end 1024 of the locking wire 1023 in the free state is more than one, the multiple loops are spaced along the axial direction of the card slot, so as to form a more reliable locking, and the maximum size of each loop is larger than the size of the card slot of the locking card slot member 1012.

[0101] It should be known that according to the technical solution provided by the embodiment of the present invention, the degradable occluder expands under the action of the delivery device and drives the locking device to form axial locking. No matter what kind of locking structure is adopted, it is achieved by axially compressing the proximal end and the distal end of the occluder to make the degradable stent expand radially, and driving the locking structure to move while expanding, so as to form axial locking, thereby improving the stability of the form and function of the occluder. The present invention can effectively overcome the problem that the degradable occluder cannot self-expand to the predetermined shape after being pushed out of the sheath tube because its material has no shape memory ability. At the same time, the locking structure is activated during the pushing process to achieve axial locking, solving the problem that the occluder cannot maintain the predetermined shape due to the pressure of the left atrial appendage wall and the insufficient performance of the material itself after expansion, and it is difficult to achieve effective and stable occlusion. In addition, the locking structure is optimized, ensuring that doctors can accurately achieve locking even in blind operation during the operation, and having the advantages of simple structure, high reliability, and flexible movement after locking. Moreover, it has a similar effect on non-degradable occluders, that is, the non-degradable stent can be locked through the locking device, so that the stent maintains the stability of the form and the radial support performance after expansion, thereby achieving effective and more stable occlusion, improving the occlusion effect, and enhancing the safety of the operation.

[0102] Moreover, in the embodiments of this application, a double-disk occluder is used as an example. Those skilled in the art should understand that the protection scope of the present invention is not limited to the double-disk occluder in the embodiments. It should be noted that a cage occluder can also be implemented in the same manner as in the above embodiments. For those skilled in the art, it should be understood that appropriate modifications can be made based on the content disclosed in the above embodiments so that the cage occluder can also achieve the same or similar effects. Simply put, compared with the double-disk occlusion type, the cage occluder cancels the occlusion disk 12 and the hollow connecting pipe 15, and only needs to be provided with a proximal connecting member 13 and a distal connecting member 14 at the proximal end and the distal end of the fixing disk 11 (i.e., the degradable stent) respectively. The proximal connecting member 13 is still connected to the outer pushing tube 21, and the inner pushing rod 22 passes through the outer pushing tube 21, the proximal connecting member 13 and the fixing disk 11 in sequence and then is connected to the distal connecting member 14. The operation process of the cage occluder is basically the same as that of the double-disk occlusion type occluder, and will not be described in detail here. In addition, a film is also provided on the occlusion disk 12 and / or the fixing disk 11.

[0103] The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention in any way. Any changes and modifications made by those of ordinary skill in the art of the present invention based on the above disclosure are within the protection scope of the present invention.

Claims

1. A medical device, characterized in that, It includes a stent, a proximal connector, a distal connector, an inner push rod, and a locking device; the proximal connector is connected to the proximal end of the stent, and the distal connector is connected to the distal end of the stent; the inner push rod has a cavity; The locking device includes locking wires and a locking groove member in at least two forms; the locking groove member has a groove and is connected to the proximal connector; One end of the locking wire is connected to the distal connector, and the other end forms a free end; the free end of the locking wire forms a first form in the free state; the free end of the locking wire forms a second form in the cavity of the inner push rod; the locking wire is made of a shape memory material, and the free end of the locking wire bends at least one turn in the free state to form the first form; After the stent radially expands to a predetermined size, the free end of the locking wire disengages from the cavity of the inner push rod and assumes the first form, and the locking wire cooperates with the groove in the first form to lock.

2. The medical device according to claim 1, characterized in that, The diameter of the locking wire is 0.3 mm to 0.6 mm.

3. The medical device according to claim 1, characterized in that, The locking groove member is configured as a hollow tubular structure with a distal opening; the inner cavity of the hollow tubular structure and the distal opening form the groove, and the size of the opening is smaller than the size of the inner cavity.

4. The medical device according to claim 3, characterized in that, The first form of the locking wire includes a linear portion capable of passing through the groove and a specific shape portion matching the inner cavity of the hollow tubular structure.

5. The medical device according to any one of claims 1-4, characterized in that, The stent includes a fixing disk and a blocking disk, and the fixing disk and the blocking disk are connected by a hollow connecting tube; the proximal connector is connected to the proximal end of the blocking disk, and the distal connector is connected to the distal end of the fixing disk; and / or the stent is made of a biodegradable material.

6. A medical system, characterized in that, It includes a delivery device and the medical device according to any one of claims 1-5; The delivery device is used to deliver the medical device to a target position and control the medical device to radially expand at the target position.

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