CN112773449A - Medical system and medical device - Google Patents

Abstract

The invention relates to a medical system and a medical device, the medical system comprises a delivery device and a medical device, the delivery device is used for delivering the medical device to a target position and controlling the radial expansion of the medical device at the target position, the medical device comprises a bracket, a proximal connecting piece, a distal connecting piece and a locking device; the near end connecting piece is connected to the near end of the bracket, and the far end connecting piece is connected to the far end of the bracket; the locking device comprises a first locking piece and a second locking piece; the first locking piece is connected with the near-end connecting piece, and the second locking piece is connected with the far-end connecting piece; the locking device is configured to be matched and locked by the first locking piece and the second locking piece after the bracket is radially expanded to a preset size; therefore, the stent still can keep the stability of the shape and the radial support performance after being radially expanded so as to better meet the requirements of plugging treatment.

Description

Medical system and medical device

Technical Field

The invention relates to the technical field of body cavity occlusion, in particular to a medical system and a medical device.

Background

Atrial fibrillation is the most common sustained arrhythmia in the clinic and is at risk of inducing ischemic stroke. The data show that more than 90% of cardiogenic thrombi are formed in the left atrial appendage in patients with non-valvular atrial fibrillation. Recent studies have shown that plugging the left atrial appendage is effective in preventing the risk of ischemic stroke due to atrial fibrillation. Since the first clinical application of plugging of the left auricle in 2001 for preventing the thromboembolic event of atrial fibrillation, the clinical application of plugging of the left auricle at home and abroad is rapidly developed, and the plugging of the left auricle becomes an important method for preventing the thromboembolic event of atrial fibrillation patients. Meanwhile, different types of left atrial appendage occlusion devices are continuously published, so that the clinical requirements are better met, and the curative effect and the safety of the operation are improved.

The occluder used for left atrial appendage occlusion in the prior art can be basically divided into two types, one type is a cage-shaped occluder represented by Watchman, and the occluder is characterized in that a self-expansion frame formed by integral cutting is provided with anchoring part hooks around the self-expansion frame, the atrial surface is covered with a porous osmotic membrane, and the occluder is placed in the left atrial appendage cavity to play a role in occlusion when in use. The other type of double-disc type occluder represented by lamb is characterized by being formed by connecting a positioning disc and an occluding disc, wherein the positioning disc is embedded in the left auricle to achieve the riveting effect and also can achieve a certain occluding effect when in use, and then the occlusion disc attached to the left auricle is mainly used for achieving the occluding effect. Both current occluders share a common feature, namely being made primarily of nitinol, which once implanted in the human body will accompany the patient throughout their life. Because the materials can not be degraded, the materials can react with human tissues to inflammation, blood coagulation and the like after long-term implantation, and even can cause certain damage.

Furthermore, there may be the following risks: (1) nitinol is a non-degradable metallic material, and although its biocompatibility has been demonstrated, the long-term risk of permanent implantation is still not fully predictable and controllable; (2) the left auricle occluder permanently remains in the heart and lacks long-term follow-up data on the safety of the human body; (3) there is no clear scientific demonstration of complications such as nickel precipitation and allergy. In addition, when the left atrial appendage is completely endothelialized, the left atrial appendage occluder loses its effect and is not necessary to remain in the body. Therefore, the ideal left atrial appendage occluder should provide a temporarily-built bridge for the endothelialization of the left atrial appendage, and be degraded by the organism after the endothelialization is completed, so that the left atrial appendage occlusion is finally completed by the self tissue completely, thereby avoiding long-term complications and potential safety hazards caused by the retention of foreign matters. Therefore, there has been proposed a degradable left atrial appendage occluder which is not widely used, mainly because the degradable material does not have shape memory and cannot self-expand to a predetermined shape, and even if the degradable material is expanded to the predetermined shape by a certain means, the degradable material cannot maintain the predetermined shape after being released from an external force, and thus it is difficult to achieve effective and stable occlusion. Not only here, although the existing non-degradable occluder can self-expand to a predetermined shape, it is also easy to be deformed by force during long-term use, and difficult to maintain the stability of the shape and the radial support performance, affecting the occlusion effect. In addition, occluders in cardiac defects or other environments can have similar problems.

Disclosure of Invention

In view of the problems of the prior art, an object of the present invention is to provide a medical system and a medical device which solve the problem that a stent for occluding a body lumen cannot maintain the stability of the shape and the radial support performance after expanding in the body lumen, thereby achieving effective and stable occlusion and improving the safety of such a procedure.

In order to achieve the above object, according to a first aspect of the present invention, there is provided a medical device comprising a stent, a proximal connector, a distal connector and a locking device; the proximal end connecting piece is connected to the proximal end of the bracket, and the distal end connecting piece is connected to the distal end of the bracket;

the locking device comprises a first locking piece and a second locking piece; the first locking piece is connected with the near-end connecting piece, and the second locking piece is connected with the far-end connecting piece; the locking device is configured such that the first locking member and the second locking member cooperatively lock upon radial expansion of the stent to a predetermined size.

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

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

Optionally, the first locking member or the second locking member having the clamping groove is a hollow tubular structure, the clamping groove is formed inside the hollow tubular structure, one end of the clamping groove forms the flaring-shaped guiding portion, and the cross section width of the guiding portion is 3.0mm to 4.0 mm.

Optionally, the first locking member or the second locking member with a buckle is a hollow rod-shaped structure, and one end of the hollow rod-shaped structure forms a spherical or ellipsoidal buckle.

Optionally, the first locking part is provided with the buckle, and the second locking part is provided with the clamping groove.

Optionally, the second locking member and the first locking member are provided with a channel allowing an inner pushing rod to pass through, and the diameter of the channel is 1.05-1.1 times of the diameter of the inner pushing rod.

Optionally, the second locking member has a fixed end and a free end opposite to each other;

the fixed end is connected with the far-end connecting piece, and the free end is arranged in the bracket in an initial state and is configured to move relative to the bracket until being locked with the first locking piece after being acted by external force.

Optionally, the second locking member comprises a pull wire and a movable member; one end of the traction wire forms the fixed end, and the other end of the traction wire is connected with the movable piece; the movable member has the free end and is configured to lock with the first locking member.

Optionally, the second locking element further includes a driving element, the driving element is connected to the movable element, and the driving element is used for pulling the movable element to move relative to the bracket.

Optionally, the locking device is a ribbon-type locking structure, one of the first locking member and the second locking member has a locking hole, and the other one of the first locking member and the second locking member has a fishbone-shaped body, and the fishbone-shaped body is used for being matched and locked with the locking hole.

Optionally, the bracket comprises a fixed disc and a plugging disc, and the fixed disc is connected with the plugging disc through a hollow connecting pipe; the near-end connecting piece is connected to the near end of the plugging disc, and the far-end connecting piece is connected to the far end of the fixed disc; and/or, the scaffold is made of a degradable material.

In order to achieve the above object, according to a second aspect of the present invention, there is provided a medical device comprising a stent, a proximal connecting member, a distal connecting member and a locking device; the proximal end connecting piece is connected to the proximal end of the bracket, and the distal end connecting piece is connected to the distal end of the bracket;

the locking device comprises at least two forms of locking wires and locking slot pieces; the locking clamping groove piece is provided with a clamping groove and is connected with the near-end connecting piece;

one end of the locking wire is connected with the far-end connecting piece, and the other end of the locking wire forms a free end; the free end of the locking wire forms a first shape in a free state;

when the stent is radially expanded to a preset size, the locking wire is matched and locked with the clamping groove in a first shape.

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

Optionally, the diameter of the locking wire is 0.3mm-0.6 mm.

Optionally, the locking notch member is configured as a hollow tubular structure with a distal end open; the lumen of the hollow tubular structure and the distal opening form the slot, the size of the opening being smaller than the size of the lumen.

Optionally, the first shape of the locking wire comprises a linear portion capable of passing through the slot and a specially shaped portion matching the lumen of the hollow tubular structure.

Optionally, the medical device further includes an inner pushing rod, the inner pushing rod has a cavity, the free end of the locking wire is in the second shape in the cavity of the inner pushing rod, and when the stent is expanded to a predetermined size, the free end of the locking wire is separated from the cavity of the inner pushing rod to be in the first shape.

In order to achieve the above object, according to a third aspect of the present invention, there is provided a medical system comprising a delivery device and a medical device, the delivery device being configured to deliver the medical device to a target site and to control radial expansion of the medical device at the target site.

The medical system and the medical device provided by the invention have the following advantages:

firstly, the medical device can utilize the conveying device to apply axial pressure to the stent so that the stent expands to a preset shape after going out of a sheath tube, thereby realizing effective plugging of a target part (such as an oval hole, a heart defect, an arterial duct unclosed or other congenital heart diseases and other environments), ensuring the plugging effect, improving the surgical curative effect, on the one hand, the stent can drive the anchoring part on the stent to expand outwards and penetrate into the target position for fixation while expanding, realizing the stable and reliable connection between the stent, particularly a degradable stent, and the target position, improving the firmness of the fixation of the plugging stent, ensuring the safety of plugging, and ensuring the life safety of a patient; meanwhile, after the stent is radially expanded to a preset size, the stent can be locked through the locking device, so that the expanded stent keeps the stability of the shape and the radial support performance, thereby realizing effective and more stable plugging, improving the plugging effect and improving the safety of the operation;

secondly, the locking device in the medical device can be provided with a fixed end and a free end, wherein the free end is arranged in the bracket in an initial state and moves relative to the bracket until being locked with the first locking device after being acted by external force; the structure can ensure that the axial length of the stent is fixed, and simultaneously, the stent has good axial bending performance so as to adapt to body cavities with different axial directions of the main body and the mouth;

thirdly, the locking device in the medical device can adopt a ribbon type locking structure, the structure not only can ensure the axial bendable performance after locking, but also can realize the adjustment of the locking length of the degradable stent, thereby ensuring that the medical device is more flexible and convenient to use and has better adaptability to body cavities with different shapes and sizes;

fourthly, when the locking device in the medical device adopts a buckle type locking structure, a spherical or ellipsoidal buckle is preferably selected for locking, so that the medical device has good axial bending capability, and the plugging performance of the device on body cavities with different shapes, particularly body cavities with different axes with the mouth part is improved;

fifthly, when the locking device in the medical device adopts a buckle type locking structure, the locking wire is preferably used for locking, on one hand, the locking of a doctor in a blind operation state can be realized, the condition that the locking cannot be realized due to dislocation is avoided, the operation difficulty is reduced, on the other hand, the occluder can still have the axial flexible bending capability after being locked, the occlusion performance of the occluder to body cavities with different shapes, particularly body cavities with different axes of a body part and an oral part, on the other hand, the whole locking device is small in size, the occluder can be more favorably collected into a delivery sheath tube, the recovery performance is good, the whole locking device is simple in structure, high in reliability and convenient to operate.

Drawings

Figure 1 is a schematic perspective view of an occluding device in a preferred embodiment of the present invention, wherein the occluding device has been pushed out of a delivery sheath and pushed to radially expand and axially lock;

FIG. 2a is a schematic view of the locking of the occluding device by a snap-in structure in the preferred embodiment of the present invention;

figure 2b is a schematic view of the occluder locking by a stay-cord type structure in the preferred embodiment of the present invention;

figure 2c is a schematic view of the occluder locking by a ribbon structure in the preferred embodiment of the present invention;

figure 3a is a schematic perspective view of the occluding device with a guide portion of a locking device in a preferred embodiment of the present invention, wherein the occluding device has been pushed out of the delivery sheath and pushed to radially expand and axially lock;

figure 3b is a schematic view of the stopper with the guide of the locking device and the delivery device fitted thereto in a preferred embodiment of the invention;

FIG. 3c is a partial schematic view of the occluder locking by a ball-end type snap in the preferred embodiment of the present invention;

figure 4a is a schematic view of the occluder in a preferred embodiment of the present invention before the locking wire is released when the occluder is locked by the locking wire;

FIG. 4b is a schematic view of the occluder in the preferred embodiment of the present invention after the locking wire is released when the occluder is locked by the locking wire;

FIG. 4c is a schematic illustration of the free end of the locking wire bent a single turn in accordance with a preferred embodiment of the present invention;

FIG. 4d is a schematic illustration of the locking wire in a preferred embodiment of the present invention with three free end turns;

figure 5 is a schematic illustration of the preferred embodiment of the invention after release and before expansion;

FIG. 6 is a schematic view of the preferred embodiment of the invention showing the occluding device being expanded under pressure and the two locking members approaching each other;

figure 7 is a schematic view of the preferred embodiment of the invention after the occluder has been expanded by pressure and the two locking members have been locked;

figure 8 is a schematic view of the preferred embodiment of the invention with the outer push tube and inner push rod removed after the occluder has been expanded under pressure and the two locking members locked.

The reference numerals are explained below:

10-an occluder; 11-fixing the disc; 12-plugging disc; 13-a proximal connector; 14-a distal connector; 15-hollow connecting pipe; 16-an anchoring portion;

20-a conveying device; 21-outer push pipe; 22-inner push rod;

200-a delivery sheath;

100-a locking device;

101-a first locking member; 1011-fastening; 1012-locking the slot member; 101 a-a fishbone-shaped body;

102-a second locking element; 1021-a guide; 1022-card slot; 1023-locking wire; 1024 — free end of locking wire; 103-drawing wires; 104-a movable member; 102 a-keyhole; 23-a drive member;

s-left atrial appendage.

Detailed Description

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.

It should be understood that the structures, ratios, sizes, and the like shown in the drawings and described in the specification are only used for matching with the disclosure of the specification, so as to be understood and read by those skilled in the art, and are not used to limit the conditions under which the present invention can be implemented, so that the present invention has no technical significance, and any structural modification, ratio relationship change, or size adjustment should still fall within the scope of the present invention without affecting the efficacy and the achievable purpose of the present invention. In addition, the terms "upper", "lower", "left", "right", "middle" and "one" used in the present specification are for clarity of description, and are not intended to limit the scope of the present invention, and the relative relationship between the terms and the terms is not to be construed as a scope of the present invention.

Herein, proximal refers to the end of the medical device that is closer to the operator, distal refers to the end of the medical device that is further from the operator, and radial refers to the direction perpendicular to the axis of the medical device.

In order to solve the technical problems in the background art, the invention provides a novel medical device which can keep the stability of the shape and the radial supporting performance of a blocking stent after the blocking stent is radially expanded so as to better meet the blocking treatment requirement. Preferably, the occluding stent is capable of degradation, allowing it to achieve controlled expansion to a predetermined shape at a target site without shape memory, while maintaining its shape stability and radial support properties after removal of external forces. It will be appreciated that the medical device provided by the present invention may be applied to the left atrial appendage and may also be applied in environments such as patent foramen ovale, heart defects, patent ductus arteriosus, or other congenital heart diseases.

In addition, the invention also provides a medical system, which comprises a medical device and a delivery device, wherein the delivery device is used for delivering the medical device to a target position in a body, controlling the medical device to radially expand at the target position and controlling the medical device to realize axial locking.

In the following, to illustrate the technical solution provided by the present invention, a left atrial appendage occluder is taken as an application example. The occluder provided by the present invention may be degradable or non-degradable, preferably degradable. When the occluder is not degradable, the problem that the occluder is difficult to maintain the stability of the shape and the radial support performance due to the long-term implantation stress deformation is avoided, and the occlusion performance of the non-degradable occluder is improved. When the occluder is degradable, the problems of long-term complications and potential safety hazards caused by long-term implantation of the occluder are avoided, and under the condition that the material does not have shape memory capacity, the purpose of expanding the occluder to a preset shape can be achieved, the occlusion performance of the left auricle is ensured, the stable and reliable connection between the occluder and the left auricle can be realized, the firmness of fixation of the occluder is improved, the safety of the occluder is improved, the life safety of a patient is ensured, and especially, the stability and the radial support performance of the shape of the occluder can be kept after the external force action is removed. The occluder is pushed out of a delivery sheath after being delivered to a target position in a body by a delivery device, and then the occluder is pushed or pulled by the delivery device to be expanded in a controlled radial direction under axial stress until the occluder expands to a preset shape, and the occluder can drive an anchoring part on the occluder to expand outwards and penetrate into the inner wall of the left auricle while expanding, so that the occluder and the left auricle form reliable connection.

It should be understood that the occluder of the present embodiment may be a cage-shaped inner plug occluder, or may be a double-disc occluder, where the double-disc occluder is used for both outer sealing and inner sealing. It should still know, to two disk occluders, when in actual use, can realize the shutoff in the inner chamber of left auricle with fixed disk and shutoff dish are whole to be filled in, also can only fill in the inner chamber of left auricle with the fixed disk, and the shutoff dish carries out the shutoff in the oral area department of outside, perhaps in the atrial septal defect, fixed disk and shutoff dish can carry out the shutoff in the both sides of atrial septal.

Although the degradable occluder is used as an illustration to show that the medical device is easy to maintain the stability of the shape and the radial support performance after radial expansion by the locking device, the degradable occluder is not a limitation of the present invention, the medical device of the present invention may be non-degradable, and the embodiments provided below for the degradable occluder are also applicable to the non-degradable occluder.

Further, the material of the occluder is degradable high polymer material and/or degradable metal material. In some embodiments, the occluder is in the form of a cage, and in this case, the occluder comprises only one fixed disk, which can be cut or woven, preferably from a degradable metal tube. In other embodiments, the occluder is a double-disc type, and at this moment, the occluder comprises a plugging disc besides a fixed disc, the plugging disc and the fixed disc are connected through a hollow connecting pipe, the processing modes of the fixed disc and the plugging disc can be the same or different, the fixed disc is preferably formed by cutting a degradable metal pipe, the plugging disc can be cut or woven, preferably, the plugging disc is formed by weaving a degradable high polymer material, and the flexibility is good.

The degradable metal material used in the occluder of the present embodiment includes, but is not limited to, magnesium-based metals (e.g., magnesium alloys), zinc-based metals (zinc alloys), and iron-based metals (iron alloys). In addition, degradable polymeric materials include, but are not limited to, polylactic acid, polydioxanone, polycaprolactone, polyglycolide, and polyglycolide. It should also be understood that one or a combination of multiple materials in the degradable metal material can be selected to prepare the occluder, or one or a combination of multiple materials in the degradable polymer material can be selected to prepare the occluder, and the occluder can be entirely made of the degradable metal material only, or entirely made of the degradable polymer material only, or both the degradable metal material and the degradable polymer material.

In addition, whether the occluder is of a double-disc type or a cage-shaped inner plug type, and whether degradable or non-degradable, the occluder provided by the embodiment comprises a stent, a proximal connecting piece and a distal connecting piece. The bracket forms a main body of the occluder, the near end of the bracket is connected with the near end connecting piece, and the far end of the bracket is connected with the far end connecting piece. When the plugging device is in a cage shape and is in an inner plug shape, the bracket only comprises a fixed disc, and the near end and the far end of the fixed disc are respectively connected with a near end connecting piece and a far end connecting piece; when the occluder is in a double-disc type, the support comprises an occluder disc and a fixed disc, wherein the far end of the fixed disc is connected with a far-end connecting piece, and the near end of the occluder disc is connected with a near-end connecting piece.

Furthermore, the delivery device for delivering the occluder comprises an outer push tube for detachable connection with the proximal connection piece. In some embodiments, the delivery device further comprises an inner push rod for detachably connecting to the distal connector after passing through the outer push tube, the proximal connector, and the stent. In practice, after the occluder is delivered to a target position by the delivery device and pushed out of the delivery sheath, as long as one of the outer delivery tube and the inner delivery rod is kept still and the other one is moved to a predetermined direction (the predetermined direction is the direction of movement towards the proximal end or the distal end of the occluder), the occluder can be expanded from a collapsed configuration to an expanded configuration after being subjected to axial pressure by the delivery device, and after the occluder is expanded to a predetermined size, the locking device on the occluder is triggered to be in a locking position so that the occluder is maintained in the predetermined size and the predetermined shape. And in the expanding process of the occluder, the original folded anchoring part is gradually expanded outwards and finally pierces the inner wall of the left auricle, so that the occluder and the left auricle are ensured to form stable connection. In other embodiments, the inner pusher rod is replaced with a driving member (e.g., a tether) that is pulled proximally to cause radial expansion of the occluding device.

And the occluding device further comprises locking means for axially locking the occluding device after the occluding device is expanded to a predetermined shape and size. The locking device specifically comprises a first locking piece and a second locking piece; the first locking piece is connected with the near-end connecting piece, and the second locking piece is connected with the far-end connecting piece; during expansion of the stent, the first locking element and the second locking element move towards each other and gradually approach until the first locking element and the second locking element are matched and locked.

Next, in order to make the above objects, features and advantages of the present invention more comprehensible, preferred embodiments of the present invention are described in detail with reference to the accompanying drawings. And for the sake of simplicity in the following description it is assumed that the occluder is a degradable double disc occluder, a person skilled in the art should be able to modify the following description, apply it to the case of the caged plug type, and apply it to the case of a non-degradable occluder, with appropriate modifications in detail. Whilst for the purposes of explanation the following description assumes that the occluder is a left atrial appendage occluder, those skilled in the art will be able to modify the following description where appropriate with appropriate modification in detail for situations other than a left atrial appendage occluder.

Fig. 1 is a schematic perspective view of an occluder according to a preferred embodiment of the present invention. As shown in fig. 1, the present embodiment relates to an occluder 10 comprising a fixed disk 11 and an occluding disk 12. Preferably, the fixed disk 11 is formed by cutting a degradable metal pipe, so that the fixed disk 11 has good strength and good shaping capability, and the plugging effect is good. Preferably, the plugging disc 12 is formed by cutting or weaving degradable polymer materials, so that the plugging disc 12 is more flexible than the fixed disc 11, and the plugging device 10 has good compliance. In another embodiment, only the stationary disk 11 may be free of the plugging disk 12. Preferably, the fixed disc 11 and the plugging disc 12 are made of different materials and have different processing technologies, so as to enhance the fixing and plugging performance of the plugging device.

In this embodiment, shutoff dish 12 is woven by degradable macromolecular material and is formed, has the characteristics that softness and compliance are good, is favorable to strengthening the closure dish 12 and the laminating nature of left auricle portion, promotes the validity of shutoff. Meanwhile, the soft plugging disc 12 is beneficial to reducing or even eliminating the damage of the left auricle part and the tissues nearby the left auricle part, and the safety of the plugging device is improved. The material of the occluding disk 12 includes, but is not limited to, polylactic acid. Simultaneously fixed disk 11 adopts the better degradable metal material of intensity and cuts and forms, is favorable to improving the anchoring part performance of plugging device in the left auricle, prevents that it from droing from the left auricle. The material of the fixed disk 11 includes, but is not limited to, magnesium alloy.

The occluder 10 further comprises a proximal connecting member 13 and a distal connecting member 14, wherein the proximal connecting member 13 is connected to the proximal end of the occluding disk 12, and the distal connecting member 14 is connected to the distal end of the fixed disk 11. In another embodiment, there may be only a holding pan 11 without a blocking pan 12, where the proximal connector 13 is attached to the proximal end of the holding pan 12 and the distal connector 14 is attached to the distal end of the holding pan 11. The proximal end connecting piece 13 is integrally formed or separately connected with the plugging disc 12. The distal end connector 14 is integrally formed with or separately connected to the fixed plate 11. Or when the blocking disk 12 is not arranged, the proximal connecting piece 13 and the distal connecting piece 14 are integrally formed or separately connected with the fixed disk 11.

The occluder 10 further comprises a locking device 100, for example, a locking device 100 is arranged at the position of the rectangular frame indicated by a1 in fig. 1, and the locking device 100 specifically comprises a first locking member 101 and a second locking member 102. The first locking piece 101 is connected with the proximal end connecting piece 13, and the first locking piece and the proximal end connecting piece can be integrally formed or connected in a split mode; the second locking element 102 is connected to the distal connecting element 14, and may be integrally formed or separately connected. The locking device 100 functions to axially lock the occluding device 10 after the occluding device 10 is expanded to a predetermined shape, so that the occluding device 10 maintains the stability of the shape and the radial supporting force after the external force is removed. Fig. 1 shows the occluder 10 in a locked state after being pushed out of the delivery sheath 200 (see fig. 2a) and released for expansion. Here, it is understood that if the occluding device 10 is degradable, it is expanded after being unsheathed by an external force, as in the present embodiment the degradable occluding device is controlled to expand by a delivery device; if the occluder 10 is not degradable, the occluder 10 can self-expand after being unsheathed by using the elasticity of the occluder, and at the moment, the occluder is pushed out of the sheath by the delivery device without controlling the expansion of the occluder by the delivery device.

With further reference to fig. 5 to 8, the operation of the occluding device 10 of the present embodiment will be further described.

As shown in fig. 5, after the occluder 10 is delivered to a target site (e.g. the fixed disk 11 is located in the left atrial appendage S, and the occluding disk 12 is located outside the left atrial appendage S and corresponds to the mouth of the left atrial appendage) and pushed out of the delivery sheath 200, the position and angle of the occluder 10 can be adjusted by moving or rotating the occluder 10 by a delivery device (e.g. the outer push tube 21 or the inner push rod 22 in fig. 3 b) before expansion.

As shown in figure 6, when the position and angle of the occluding device 10 are adjusted by the operator, the occluding device 10 is compressed (i.e. the left and right arrows are compressed axially) by the delivery device (e.g. the inner pushing rod 22 is kept still, the outer pushing rod 21 is moved distally, or the outer pushing rod 21 is kept still, and the inner pushing rod 22 is moved proximally) to expand from the collapsed state to the expanded state (i.e. the up and down arrows are expanded radially). Here, it should be understood that, in the process of pushing expansion, when the plugging disc 12 is made of a softer material such as polylactic acid, the plugging disc 12 may be expanded and restored to a predetermined shape at first, and then the fixed disc 11 is expanded, 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 are not locked yet.

As shown in fig. 7, when the occluder 10 continues to expand under the push of the delivery device 20 and the occluder 10 expands to a predetermined shape, the first locking member 101 and the second locking member 102 are locked in cooperation, so that the occluder 10 is axially locked, and the occluder 10 still maintains the current shape after the axial pressure is removed, thereby ensuring the stability of the shape and the reliability of the function of the occluder 10.

After successful release, inflation and locking of the occluding device 10, the operator withdraws the delivery device 20 from the body (the inner pusher rod 22 and the outer pusher tube 21 are withdrawn from the body in succession) to complete the occlusion procedure, as shown in figure 8.

Furthermore, it should be understood that during the expansion of the occluder 10, the anchoring portion 16 on the fixation disk 11 opens in a direction away from the axis of the fixation disk 11 and gradually penetrates into the inner wall of the left atrial appendage, so that the occluder 10 and the left atrial appendage form a firm and reliable connection.

In more detail, the occluding device 10 has an initial state in which the occluding device 10 is not expanded, as shown in fig. 5, and has a long axial length and a small radial dimension, i.e. the occluding device 10 is in a collapsed configuration; the occluding device 10 also has an expanded state wherein the occluding device 10 is axially compressed and radially expanded as shown in figures 6 to 8. In practical application, in the expansion process of the occluder 10, the originally folded anchoring part 16 is gradually expanded outwards and finally penetrates into the inner wall of the left atrial appendage; generally, after the occluding device 10 is radially expanded to a predetermined size and the occluding device 10 is securely attached to the left atrial appendage, the delivery device 20 may be withdrawn to complete the occlusion of the left atrial appendage. It will be appreciated that the conventional non-degradable anchoring portion 16 has a shape memory function and is able to self-expand outward, whereas the anchoring portion 16 of the present embodiment is not able to self-expand outward if it is degradable, and therefore it is necessary to cause the anchoring portion 16 to expand outward by virtue of the expansion of the occluding device 10, so that the anchoring portion 16 penetrates into the inner wall of the left atrial appendage. Further, because the anchors (i.e., anchors 16) are cut into the struts of the anchor disk 12, the width of the struts (i.e., the struts forming the anchors) is reduced and thus more flexible than elsewhere, and thus naturally expands in the area of the anchors 16 as the occluding device 10 is moved from the collapsed state to the expanded or expanded state.

It will also be appreciated that for the dual disc occluder 10 the expansion sequence may be adjusted, for example by expanding the occluding disc 12 before expanding the retention disc 11, or by expanding the retention disc 11 before expanding the occluding disc 12, or by expanding both the retention disc 11 and the occluding disc 12, all of which may be controlled by material and size considerations. For example, when the fixed disk 11 is more flexible than the plugging disk 12, after the plugging device 10 is pushed out of the sheath, the fixed disk 11 expands first under the condition of axial compression, and when the fixed disk 11 completes expansion, the plugging disk 12 begins to expand; if the plugging disc 12 is more flexible than the fixed disc 11, the plugging disc 12 expands first under the condition of axial compression after the plugging device 10 is pushed out of the sheath, and the fixed disc 11 begins to expand after the plugging disc 12 completes expansion; if the flexibility of the plugging disc 12 and the fixed disc 11 is equivalent, the plugging disc 12 and the fixed disc 11 can expand simultaneously, namely, after being pushed out of the sheath, the plugging disc 12 and the fixed disc 11 start to expand simultaneously under the condition of axial compression. Here, by adjusting the expansion sequence, the operation of the doctor can be facilitated.

Further, the locking device 100 can adjust different locking structure forms according to different requirements, for example, a snap-in locking structure, a pull-cord locking structure, a ribbon-type locking structure, etc. are adopted, and the first locking member 101 and the second locking member 102 are locked to keep the occluder 10 in an axial locking state and fixed at the left atrial appendage.

In one embodiment, as shown in fig. 2a, the locking device 100 adopts a snap-in locking structure, in which one of the first locking member 101 and the second locking member 102 has a snap and the other has a snap groove, and the axial locking of the occluder 10 is maintained by the locking of the snap groove and the snap. In this embodiment, the first locking member 101 has a snap, and the second locking member 102 has a snap groove, and further, the first locking member 101 is a hollow tubular structure and forms a snap at a distal end of the hollow tubular structure. The buckles can be triangular or in other suitable shapes, and the number of the buckles can be one or more. Further, the second locking member 102 is a hollow tubular structure, and a plurality of slots are disposed on an inner wall of a proximal end of the hollow tubular structure, where the number of the slots corresponds to the number of the fasteners. By adopting the structure, the locking of the occluder 10 in a certain axial length can be realized, and the locking length of the occluder 10 is not adjustable.

In another embodiment, the second locking element 102 has a fixed end connected to the distal link 14 and a free end initially disposed within the holder and configured to move relative to the holder upon application of an external force until locking with the first locking element 101. Preferably, the first locking member 101 is a proximal connecting member 13. Further, as shown in fig. 2b, the second locking member 102 comprises a pull wire 103 and a movable member 104, wherein one end of the pull wire 103 forms a fixed end and the other end is connected to the movable member 104, and the movable member 104 has a free end and is configured to be locked to the first locking member 101, preferably to the proximal connecting member 13. Further, the second locking member 102 further includes an actuating member 23, the actuating member 23 is connected to the movable member 104, and the actuating member 23 is used for driving the movable member 104 to move relative to the bracket, such as relative to the fixed tray 11. Preferably, the drive member 23 has a proximal handle. In some embodiments, the driving element 23 is a rope, and the movable element 104 is provided with a through hole for passing the rope, the through hole is not required to be arranged, the number of the through holes can be one or more, and the rope and the through hole can be relatively fixed or relatively movable so as to be released. In other embodiments, the moveable member 104 is threadably coupled to the driving member 23. In more detail, in the initial state, the movable member 104 is located inside the occluding device 10 (shown by the dotted line), and after the occluding device 10 is pushed out of the delivery sheath 200, the outer delivery tube 21 is kept stationary, and the driving member 23 is pulled proximally, so that the driving member 23 pulls the movable member 104 and thus the distal connecting member 14 to move proximally, so that the occluding device 10 is expanded. And as the moveable member 104 passes through the proximal connector 13 and further out of the proximal connector 13 under continued pulling of the driving member 23, the moveable member 104 locks with the proximal connector 13, i.e., the moveable member 104 locks by its own dimension abutting against the proximal end face of the proximal connector 13. By adopting the structure, the axial length of the plugging device can be ensured to be fixed, and meanwhile, the plugging device still has good axial bending performance so as to adapt to the left auricle with the degradable bracket and the non-coaxial left auricle opening.

In another embodiment, as shown in fig. 2c, the locking device 100 adopts a ribbon-type locking structure, in this locking mode, the locking device 100 includes a fishbone ribbon, specifically, the first locking member 101 includes a fishbone-shaped body 101a, the second locking member 102 includes a locking hole 102a snap-fit with the fishbone-shaped body 101a, and the fishbone-shaped body 101a is inserted into the locking hole 102a for locking. By adopting the structure, the axial bending performance of the locked occluder 10 can be ensured, and the locking length of the occluder can be adjusted, so that the occluder is more flexible to use and has better adaptability to left auricles with different shapes and sizes. In further embodiments, the second lock 102 comprises a fishbone-shaped body 101a and the first lock 101 comprises a lock hole 102 a.

It should be understood that the above-described locking manner is only an example and does not constitute a limitation on the structure of the locking device 100 of the present invention.

Further, the locking device 100 is made of degradable material or non-degradable material. The degradable polymer material for preparing the locking device 100 includes, but is not limited to, polylactic acid, polydioxanone, polycaprolactone, polyglycolide, and the like. The degradable metal material for making the locking device 100 includes, but is not limited to, degradable magnesium alloys, zinc alloys, pure iron, etc. In addition, the locking device 100 may be integrally formed with the degradable stent or separately attached. In this embodiment, the second locking element 102 is integrally formed or separately connected to the distal connecting element 14, and the first locking element 101 is integrally formed or separately connected to the proximal connecting element 13. In addition, the locking object can be a certain deformable part of the plugging device, such as the locking fixing disc 11 or the plugging disc 12, which is locked independently, or the fixing disc 11 and the plugging disc 12 can be locked simultaneously.

Further, considering that the operator cannot accurately observe the movement of the locking device 100 during the operation, and may cause the first locking member 101 and the second locking member 102 to be dislocated from each other and cannot be locked, a guiding portion 1021 (fig. 3c) is added to the locking member providing the slot, and the guiding portion 1021 is used for guiding the clip to be smoothly locked with the slot.

As further shown in fig. 3a to 3c, the second locking member 102 preferably has a locking groove 1022, and the first locking member 101 has a catch 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 of which form a passage inside for allowing the inner push rod 22 to pass through. More preferably, the second locking member 102 has a guiding portion 1021 with a flared shape, and the guiding portion 1021 is located at the proximal end of the locking groove 1022. The maximum cross-sectional width (preferably, the maximum outer diameter) of the guide 1021 is preferably 3mm to 4mm, but not too large or too small; if the diameter is too small, the guiding function cannot be well played; if the diameter is too large, the occluding device 10 cannot be retracted into the delivery sheath 200. The shape of the latch 1011 is not limited in this embodiment, and preferably, the first locking member 101 has a spherical or ellipsoidal latch 1011 to ensure that the first locking member 101 can be latched into the second locking member 102 from various directions, so as to ensure smooth locking in a blind operation environment, and further reduce the difficulty of the operation. In this embodiment, when the spherical or ellipsoidal or other suitable shape of the latch 1011 is latched into the latch 1022, the latch 1011 is latched into the latch 1022 by the elasticity of the material under the action of external force because the opening of the latch is slightly smaller than the latch 1011 and the latch is squeezed by each other. After the buckle 1011 enters the clamping groove 1022, the clamping groove opening recovers the original size, so that the buckle 1011 can not be easily separated, and the locking is realized. After the locking is finished, a structure similar to a bone joint is formed, and the plugging device is ensured to have good axial flexible bending capability after the locking, so that the plugging performance of the plugging device on different forms of auricles, particularly left auricles with body parts not coaxial with the mouth part, is improved.

With continued reference to FIG. 3b, the present embodiment provides a delivery device 20 comprising an outer push tube 21, the outer push tube 21 being adapted to be removably coupled to the proximal connector 13. In some embodiments, the delivery device 20 further includes an inner push rod 22, the inner push rod 22 being adapted to removably couple with the distal connector 14. The inner push rod 22 passes through the outer push tube 21 and through the stopper body to connect with the distal connection 14 and is adapted to provide an axial compression force to the stopper 10 in cooperation with the outer push tube 21 when expanded, for the purpose of causing radial expansion of the stopper 10. The inner push rod 22 may be a rod capable of being axially compressed, or may be a flexible body (e.g., a wire, a rope, a string, etc., preferably a guide wire) capable of being axially tensioned. The flexible body is relatively smaller in size, which facilitates reducing the size of the delivery device 20. The flexible body can be detachably connected with the far end of the occluder 10 in a perforation way, the perforation can be one or more, and the axis of the perforation can be parallel or perpendicular to the axis of the fixed disk 11. In other embodiments, the delivery device 20 further includes the aforementioned drive member 23 without the inner push rod 22. The driving member 23 is adapted to provide an axial pressure to the occluder 10 in cooperation with the outer push tube 21 during expansion, so as to radially expand the occluder 10.

The connection mode of the outer push tube 21 and the proximal end connector 13 can be adjusted according to actual requirements, such as selecting one or more combinations of mechanical connection modes such as threads, buckles, clamps, perforations and the like or other non-mechanical connection modes. Similarly, the connection mode between the inner push rod 22 and the distal end connector 14 can be adjusted according to actual requirements, and the detachable connection can be one or more combinations of mechanical connection such as threads, buckles, clamps, and holes, or other non-mechanical connection modes. In addition, the inner push rod 22 and the outer push rod 21 may be connected in the same or different manners, for example, when the outer push rod 21 is connected in a threaded manner, the inner push rod 22 may be connected in a threaded manner or in other manners, and there is no particular requirement for the present invention. In this embodiment, the outer push tube 21 is threadedly connected to the proximal connector 13, and the inner push rod 22 is threadedly connected to the distal connector 14.

The occluder 10 further comprises a hollow connecting tube 15 and an anchor 16. The fixed disc 11 is connected with the plugging disc 12 through a hollow connecting pipe 15. The hollow connecting pipe 15 has an inner cavity which is axially communicated with the inner cavity, and is preferably integrally formed with the fixed disc 11, such as integrally cut forming, so that the structure is simplified, and the processing technology is simplified. The anchor portion 16 is connected to the fixed disk 11, and preferably, the anchor portion 16 is integrally formed with the fixed disk 11 by cutting or the anchor portion 16 is separately connected to the fixed disk 11.

Taking the inner push rod 22 as an example, as shown in fig. 3a to 3c, the inner push rod 22 passes through the outer push tube 21, the proximal connecting member 13, the first locking member 101, the hollow connecting tube 15 and the second locking member 102 in sequence and then is connected to the distal connecting member 14. Meanwhile, the interiors of the first locking piece 101 and the second locking piece 102 are both hollow structures to form a channel, the diameter of the channel is slightly larger than that of the inner push rod 22, and is 1.05-1.1 times of the diameter of the inner push rod 22, so that the inner push rod 22 can pass through the locking device 100; the smoothness of the sliding of the locking device 100 on the inner pushing rod 22 can be ensured, and the first locking piece 101 and the second locking piece 102 are not seriously dislocated when approaching each other, so that the difficulty of operation is reduced.

In still other embodiments, referring to fig. 4a and 4b, the second locking member 102 preferably comprises a locking wire 1023, the first locking member 101 comprises a locking slot member 1012, and the locking slot member 1012 has a slot. The locking wire 1023 has at least two forms, a first form and a second form; when the locking wire 1023 is in the first shape, the free end 1024 of the locking wire is matched and locked with the clamping groove in a free state; when the locking wire 1023 is in the second configuration, its free end 1024 is not locked with the slot. Preferably, the locking wire 1023 is made of a shape memory material, including but not limited to nitinol, to take advantage of the shape memory of the locking wire 1023 to return to a predetermined shape after the restraint is released. The "free state" herein refers to a state in which the locking wire 1023 is not subjected to an external force. When the free end 1024 of the locking wire 1023 is in the first configuration, the free end 1024 of the locking wire resembles a snap. Such that the locking wire 1023 is cooperatively locked with the locking notch member 1012 in the first configuration after the stent is radially expanded to a predetermined size.

In more detail, one end of the locking wire 1023 is connected to the distal end connector 14, and the other end is a free end 1024 and is configured to form a first configuration in a free state. Further, the locking wire 1023 passes through the lumen of the inner push rod 22, and is limited by the size of the lumen of the inner push rod 22, and the locking wire 1023 is in a second configuration in the lumen of the inner push rod 22, and the second configuration can be a straightened state (fig. 4 a); after the deployment of the occluding device 10 is completed and the inner pusher rod 22 is withdrawn, the locking wire 1023 is released from the lumen of the inner pusher rod 22 and the free end 1024 returns to the first configuration, the free end 1024 of the first configuration having a curved portion; and because the slot size of the locking slot member 1012 is smaller than the size of the free end 1024 of the locking wire 1023 in the first configuration, the free end 1024 of the locking wire cannot be pulled out of the slot of the locking slot member 1012, forming a lock (fig. 4 b). The locking device 100 with the structure can realize the locking of a doctor in a blind operation state on one hand, and is less prone to the situation that the locking cannot be locked due to dislocation, on the other hand, the occluder can still have the axial flexible bending capability after being locked, and on the other hand, the whole locking device is small in size, so that the occluder 10 can be more conveniently put into the delivery sheath 200.

Further, considering that the locking wire 1023 should not be removed after locking, the present invention has certain requirements on the strength of the locking wire 1023, while taking into account the size and the formability of the locking wire, so the diameter of the locking wire 1023 should not be too thin or too thick, preferably 0.3mm to 0.6 mm. It should be noted that the diameter (thickness) of the locking wire affects the deformability of the locking wire, and when the slot catches the free end 1024 in the first form, the deformability of the free end 1024 must be smaller than the locking capability, i.e. the deformation force of the free end is larger than the locking force, otherwise the locking wire 1023 will be disengaged from the slot. Further, in order to increase the strength of the locking, it is appropriate to increase the number of turns or change the shape of the bending of the free end 1024 of the locking wire 1023 in the free state, and preferably, the free end 1024 of the locking wire is bent at least one turn in the free state, preferably, the number of the bending turns is 1 to 4, that is, as shown in fig. 4c or 4 d. In addition, the present invention does not limit the material of the locking wire 1023, and includes, but is not limited to, nitinol, for example. The shape of the free end 1024 of the locking wire in the free state is not limited in the present invention, and may be a spiral shape, a sphere shape, a hexahedron shape, or other randomly distributed shapes. Further, the locking notch member 1012 is configured as a hollow tubular structure with a distal opening, such that the lumen and the distal opening of the hollow tubular structure of the locking notch member 1012 form a notch, and the distal opening of the locking notch member 1012 has a smaller size than the lumen thereof, so as to increase the reliability of the locking.

Further, the first shape of the locking wire 1023 includes a linear portion that can pass through the locking slot of the locking slot member 1012 and a specially shaped portion that matches the internal cavity of the locking slot member 1012. It should be understood that matching the hollow tubular structure of the locking catch member 1012 means that the locking wire 1023 is of the same shape as the contour of the lumen structure, such that the locking wire 1023 will just catch at the distal opening of the hollow tubular structure and will not easily fall off; the matching of the hollow tubular structure with the locking slot member 1012 can also mean that the free end 1024 of the locking wire 1023 can be a plurality of rings, and the diameter of the rings is just the same as that of the inner cavity of the hollow tubular structure, so that the friction force of the rings in the inner cavity of the hollow tubular structure is increased, the locking force is enhanced, and the rings are not easy to fall off. In addition, the locking wire 1023 may be wound of a single wire or a plurality of wires. Preferably, the number of bending turns of the free end 1024 of the locking wire 1023 in a free state can be one or more, a plurality means at least two; when the number of bending turns of the free end 1024 of the locking wire 1023 in the free state is plural, the plural turns are distributed at intervals in the axial direction of the locking groove, so that more reliable locking is formed, and the maximum size of each turn is larger than the size of the locking groove 1012.

It should be understood that according to the technical scheme provided by the embodiment of the invention, the degradable occluder expands under the action of the conveying device and drives the locking device to form axial locking, no matter what locking structure is used for realizing the axial locking, the proximal end and the distal end of the occluder are axially pressed to radially expand the degradable stent and drive the locking structure to move while expanding the degradable stent to form axial locking, so that the stability of the shape and the function of the occluder is improved. The invention can effectively overcome the problem that the degradable occluder can not self-expand to the preset shape after being pushed out of the sheath because the material of the degradable occluder has no shape memory capability. Meanwhile, the locking structure is activated in the pushing and pressing process to realize axial locking, and the problem that the plugging device cannot keep a preset shape due to the fact that the plugging device is subjected to pressure of the left atrial appendage wall and insufficient performance of materials after being expanded, and effective and stable plugging is difficult to realize is solved. In addition, the locking structure is optimally designed, so that a doctor can accurately realize locking under the condition of blind operation of the operation, and the locking device has the advantages of simple structure, high reliability, flexible movement after locking and the like. And the plugging device also has similar effect to the non-degradable plugging device, namely, the non-degradable stent can be locked by the locking device, so that the expanded stent keeps the stability of the shape and the radial support performance, thereby realizing effective and more stable plugging, improving the plugging effect and improving the safety of the operation.

Not only the embodiments of the present application are exemplified by a dual-disc occluder, but those skilled in the art will appreciate that the scope of the present invention is not limited to the dual-disc occluder of the embodiments. It should be understood that the cage-shaped occluder can be implemented by the above embodiments, and those skilled in the art will appreciate that the cage-shaped occluder can achieve the same or similar effects by making appropriate modifications based on the disclosure of the above embodiments. In brief, compared with the double-disk plugging type, the cage-shaped plugging device omits the plugging disk 12 and the hollow connecting pipe 15, and only needs to arrange the proximal connecting piece 13 and the distal connecting piece 14 at the proximal end and the distal end of the fixed disk 11 (i.e. the degradable stent) respectively, the proximal connecting piece 13 is still connected with the outer push pipe 21, and the inner push rod 22 sequentially passes through the outer push pipe 21, the proximal connecting piece 13 and the fixed disk 11 and then is connected with the distal connecting piece 14. The operation of the caged occluder is substantially the same as that of the double-disc occluder type and will not be described in detail here. In addition, a coating film is also arranged on the plugging disc 12 and/or the fixed disc 11.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the present invention.

Claims (20)

1. A medical device comprising a stent, a proximal connector, a distal connector and a locking device; the proximal end connecting piece is connected to the proximal end of the bracket, and the distal end connecting piece is connected to the distal end of the bracket;

the locking device comprises a first locking piece and a second locking piece; the first locking piece is connected with the near-end connecting piece, and the second locking piece is connected with the far-end connecting piece;

the locking device is configured such that the first locking member and the second locking member cooperatively lock upon radial expansion of the stent to a predetermined size.

2. The medical device of claim 1, wherein the locking device is a snap-in locking arrangement, one of the first and second locking members having a snap fit and the other having a catch groove that mates with the snap fit.

3. The medical device according to claim 2, wherein the first locking member or the second locking member having a card slot further has a guide portion for guiding the insertion of the card into the card slot.

4. The medical device according to claim 3, wherein the first locking member or the second locking member having the catching groove is a hollow tubular structure, the catching groove is formed inside the hollow tubular structure, and one end of the catching groove is formed as the guide portion having a flared shape, and the cross-sectional width of the guide portion is 3.0mm to 4.0 mm.

5. The medical device of claim 4, wherein the first locking member or the second locking member having a snap fit is a hollow rod-like structure having one end forming a spherical or ellipsoidal snap fit.

6. The medical device of claim 5, wherein the first locking member has the catch and the second locking member has the catch.

7. The medical device of claim 6, wherein the second locking member and the first locking member each have a channel that allows an inner push rod to pass through, the channel having a diameter that is 1.05 to 1.1 times the diameter of the inner push rod.

8. The medical device of claim 1 wherein said second locking element has opposed fixed and free ends;

the fixed end is connected with the far-end connecting piece, and the free end is arranged in the bracket in an initial state and is configured to move relative to the bracket until being locked with the first locking piece after being acted by external force.

9. The medical device of claim 8, wherein the second locking element comprises a pull wire and a moveable member; one end of the traction wire forms the fixed end, and the other end of the traction wire is connected with the movable piece; the movable member has the free end and is configured to lock with the first locking member.

10. The medical device of claim 9, wherein the second locking member further comprises an actuating member coupled to the moveable member, the actuating member configured to actuate movement of the moveable member relative to the bracket.

11. The medical device of claim 1, wherein the locking device is a ribbon-type locking structure, one of the first locking member and the second locking member having a locking hole and the other having a fishbone-shaped body for cooperating locking with the locking hole.

12. The medical device of claim 1, wherein the stent comprises a fixed disk and a plugging disk, and the fixed disk and the plugging disk are connected through a hollow connecting pipe; the near-end connecting piece is connected to the near end of the plugging disc, and the far-end connecting piece is connected to the far end of the fixed disc; and/or, the scaffold is made of a degradable material.

13. A medical device comprising a stent, a proximal connector, a distal connector and a locking device; the proximal end connecting piece is connected to the proximal end of the bracket, and the distal end connecting piece is connected to the distal end of the bracket;

the locking device comprises at least two forms of locking wires and locking slot pieces; the locking clamping groove piece is provided with a clamping groove and is connected with the near-end connecting piece;

one end of the locking wire is connected with the far-end connecting piece, and the other end of the locking wire forms a free end; the free end of the locking wire forms a first shape in a free state;

when the stent is radially expanded to a preset size, the locking wire is matched and locked with the clamping groove in a first shape.

14. The medical device of claim 13, wherein the locking wire is made of a shape memory material and a free end of the locking wire is bent at least one turn in a free state to form the first configuration.

15. The medical device of claim 13, wherein the locking wire has a diameter of 0.3mm to 0.6 mm.

16. The medical device of claim 13, wherein the locking notch member is configured as a hollow tubular structure open at a distal end; the lumen of the hollow tubular structure and the distal opening form the slot, the size of the opening being smaller than the size of the lumen.

17. The medical device of claim 16, wherein the first configuration of the locking wire comprises a linear portion capable of passing through the slot and a shaped portion that matches the lumen of the hollow tubular structure.

18. The medical device of claim 13, further comprising an inner pusher rod having a lumen, wherein the free end of the locking wire is in a second configuration within the lumen of the inner pusher rod, and wherein the free end of the locking wire is disengaged from the lumen of the inner pusher rod to assume a first configuration when the stent is expanded to a predetermined size.

19. The medical device according to any one of claims 13-18, wherein the stent comprises a fixation disc and a plugging disc, the fixation disc and the plugging disc being connected by a hollow connecting tube; the near-end connecting piece is connected to the near end of the plugging disc, and the far-end connecting piece is connected to the far end of the fixed disc; and/or the scaffold is made of a degradable material.

20. A medical system comprising a delivery device and a medical device according to any of claims 1-13 or a medical device according to any of claims 13-19;

the delivery device is used to deliver the medical device to a target location and to control radial expansion of the medical device at the target location.

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