Closure device and closure system

Abstract

The application relates to a closure device and a closure system, which comprise a closure main body, a closure head connected with the distal end of the closure main body, and a plug head connected with the proximal end of the closure main body, the plug head comprises a locking hole through the inner cavity, the closure device further comprises a locking piece connected with the closure head at the distal end, the locking piece comprises a locking part arranged at the proximal end of the locking piece, the locking hole comprises an accommodating hole and a limiting hole in sequence from the proximal end to the distal end, the proximal end of the locking part can be completely accommodated in the accommodating hole when the closure device is in a first locking state, the limiting hole limits the locking part from being taken out from the distal end of the locking hole, the locking part can move in the axial direction in the accommodating hole under the action of external force, and can be deflected in the radial direction to abut against the hole wall of the accommodating hole. The closure device has good locking effect, high locking efficiency, high operation fault tolerance and high safety performance.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a closure device and a closure system. BACKGROUND

[0002] Currently, common congenital heart diseases include atrial septal defect, ventricular septal defect, patent ductus arteriosus, and patent foramen ovale. With the continuous development of interventional medical devices and interventional surgery, interventional therapy has become a more acceptable treatment method for the majority of patients. Conventional minimally invasive interventional surgery uses a heart closure device for occlusion therapy.

[0003] Currently, the heart closure device on the market generally includes a closure main body having two closure units for covering the tissue on both sides of the defect site, and most of them are made of nickel-titanium metal. In recent years, with the development of technology, closure devices made of high polymer materials have also been used for implantation. However, high polymer materials have low or no elasticity, which will cause the closure device to release from the delivery device, and the forming effect may not be as expected, and the closure device cannot be tightly attached to both sides of the defect site, thereby affecting the occlusion effect. Therefore, the closure device needs an effective restraining structure to keep the distance between the two closure units stable to ensure that the closure device forms well to ensure the occlusion reliability. SUMMARY

[0004] Based on this, the present application provides a closure device with a locking function and a closure system.

[0005] The present application provides a closure device, comprising a closure main body having an inner cavity and being deformable, a closure head connected to the distal end of the closure main body, and a plug head connected to the proximal end of the closure main body, the plug head comprising a locking hole penetrating the inner cavity, the closure device further comprising a locking member connected to the closure head at the distal end, the locking member comprising a locking portion provided at the proximal end of the locking member, the locking hole comprising an accommodating hole and a limiting hole in sequence from the proximal end to the distal end, the accommodating hole being axially penetrating, the closure device having a first locking state, when in the first locking state, the proximal end of the locking portion can be completely accommodated in the accommodating hole, the limiting hole limiting the locking portion from being pulled out of the distal end of the locking hole, and the locking portion can be axially movable in the accommodating hole under the action of an external force and can be radially deflected to abut against the hole wall of the accommodating hole.

[0006] In one embodiment, the locking member further comprises a connecting portion, the distal end of the connecting portion being connected to the closure head and the proximal end of the connecting portion being connected to the locking portion, when in the first locking state, the connecting portion can be radially deflected to a preset deflection angle under the action of an external force to drive the locking portion to be radially deflected to abut against the hole wall of the accommodating hole, and the preset deflection angle is less than or equal to 7°.

[0007] In one of the embodiments, the locking portion comprises a cylindrical body and an elastic sleeve fixedly sleeved outside the cylindrical body, a gap is formed between the elastic sleeve and the cylindrical body in the radial direction, so that the elastic sleeve can elastically deform relative to the cylindrical body in the radial direction; and / or, the inner diameter of the elastic sleeve gradually decreases from the proximal end to the distal end.

[0008] The present application provides a closure device, comprising a closure body with an inner cavity and capable of deforming, a closure head connected to the distal end of the closure body, and a plug head connected to the proximal end of the closure body, the plug head comprises a locking hole penetrating the inner cavity, the closure device further comprises a locking member connected to the closure head at the distal end, and a locking sleeve sleeved outside the locking member, the locking member comprises a locking portion arranged at the proximal end of the locking member, and the proximal end of the locking sleeve is closer to the distal end of the closure device than the proximal end of the locking portion; the closure device has a first locking state and a second locking state, when in the first locking state, the locking portion is locked and matched with the locking hole, and when in the second locking state, the locking sleeve is locked and matched with the locking hole.

[0009] In one of the embodiments, the locking sleeve is fixedly connected with the locking member; or, the locking sleeve is movably connected with the locking member, the locking hole comprises a receiving hole, when in the first locking state, the proximal end of the locking portion can be completely accommodated in the receiving hole, and when in the second locking state, the locking portion can move axially in the receiving hole and deflect radially to abut against the hole wall of the receiving hole under the action of external force.

[0010] In one of the embodiments, the locking hole comprises a receiving hole and a limiting hole in sequence from the proximal end to the distal end, when in the first locking state, the proximal end of the locking portion can be completely accommodated in the receiving hole, the limiting hole limits the locking portion from being pulled out from the distal end of the locking hole, and the locking portion can move axially in the receiving hole and deflect radially to abut against the hole wall of the receiving hole under the action of external force.

[0011] In one of the embodiments, the minimum hole diameter of the limiting hole is smaller than the maximum radial dimension of the locking portion; and / or, the length of the receiving hole is greater than or equal to the length of the locking portion, the maximum hole diameter of the receiving hole is greater than the maximum radial dimension of the locking member, and the minimum hole diameter of the receiving hole is greater than the minimum radial dimension of the locking member.

[0012] In one of the embodiments, the locking member further comprises a connecting portion, a distal end of the connecting portion is connected with the head, and a proximal end of the connecting portion is connected with the locking portion; the locking portion and the connecting portion are made of the same polymer material, which is degradable or non-degradable; the locking portion and the connecting portion satisfy one or more of the following conditions:

[0013] The density of the locking portion is less than the density of the connecting portion.

[0014] The hardness of the locking portion is less than the hardness of the connecting portion.

[0015] The elastic modulus of the locking portion is less than the elastic modulus of the connecting portion.

[0016] In one of the embodiments, the locking member further comprises a connecting portion, the locking portion comprises a guide segment connected with the proximal end of the connecting portion and a main body segment connected with the proximal end of the guide segment, the accommodating hole comprises a first hole and a second hole in sequence from the proximal end to the distal end, the second hole is in communication with the first hole and the limiting hole at the two axial ends respectively, and the radial dimension of the guide segment and the second hole gradually increases in the direction from the distal end to the proximal end.

[0017] In one of the embodiments, the locking member further comprises a connecting portion, the connecting portion comprises a connecting rod connected with the locking portion, the radial dimension of the connecting rod is less than the hole diameter of the limiting hole, and the ratio of the length of the limiting hole to the length of the locking portion ranges from 1 / 3 to 1 / 2.

[0018] In one of the embodiments, the locking member further comprises a connecting portion, the connecting portion comprises a connecting rod connected with the locking portion, the locking portion comprises a guide segment connected with the proximal end of the connecting rod and a main body segment connected with the proximal end of the guide segment, the ratio of the radial dimension of the main body segment to the radial dimension of the connecting rod ranges from 1.03 to 1.23, the ratio of the length of the main body segment to the length of the guide segment ranges from 2 to 4, and / or the ratio of the radial dimension of the main body segment to the hole diameter of the limiting hole ranges from 1.01 to 1.14.

[0019] In one of the embodiments, the main body segment is of an equal-diameter structure, or the radial dimension of the main body segment gradually increases in the direction from the distal end to the proximal end.

[0020] In one of the embodiments, the ratio of the hole diameter of the first hole to the maximum radial dimension of the main body segment ranges from 1.015 to 1.15.

[0021] In one of the embodiments, the locking member further comprises a connecting portion, the connecting portion comprises a connecting rod connected with the locking portion; the locking portion has a radial symmetry structure; or, the locking portion has a radial asymmetry structure, the locking portion comprises opposite first and second sides along a radial direction, the first side protrudes radially outward relative to the connecting rod, the second side is located at a same circumferential surface as the connecting rod, or, the second side protrudes radially outward relative to the connecting rod; the first side protrudes radially relative to the connecting rod to a greater extent than the second side.

[0022] In one of the embodiments, the occlusion device comprises a developing point, the developing point is used to indicate that the occlusion device is released in a predetermined manner, so that, after the occlusion device is released, the distal end of the connecting portion is offset relative to the proximal end of the connecting portion in a direction in which the first side protrudes.

[0023] In one of the embodiments, the locking hole further comprises a guide hole located at the distal end of the limiting hole, the guide hole is in communication with the limiting hole, and the diameter of the guide hole gradually increases from the proximal end to the distal end.

[0024] In one of the embodiments, the plug head comprises an inner sleeve and an outer sleeve, the proximal end of the occlusion body is constricted and fixed between the inner sleeve and the outer sleeve, the locking hole is located in the inner sleeve, and the distal end of the inner sleeve is flush with the distal end of the outer sleeve, or the distal end of the inner sleeve is closer to the distal end of the occlusion device than the distal end of the outer sleeve.

[0025] The present application provides an occlusion system, which comprises the occlusion device and a delivery device, the delivery device comprises a hollow pushing cable and a control cable arranged in the pushing cable, the control cable is axially movable relative to the pushing cable, and the distal end of the control cable can extend out of the distal end of the pushing cable, the proximal end of the locking member is detachably connected with the distal end of the control cable, and the plug head is detachably connected with the distal end of the pushing cable.

[0026] The locking member of the occlusion device provided by the present application comprises a connecting portion and a locking portion, and the locking portion is arranged at the proximal end of the locking member. The locking hole located in the plug head penetrates both ends of the plug head in the axial direction, and comprises an accommodating hole and a limiting hole in sequence from the proximal end to the distal end in the axial direction. The occlusion device has a first locking state, when in the first locking state, the proximal end of the locking portion can be completely accommodated in the accommodating hole, the limiting hole limits the locking portion from being pulled out of the distal end of the locking hole, and the locking portion can move axially in the accommodating hole under the action of an external force and can be deflected radially to abut against the hole wall of the accommodating hole. The occlusion device has good locking effect, high locking efficiency, high fault tolerance rate of surgical operation, and excellent safety performance. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 Structure diagram of the occluder in an embodiment of the present application;

[0028] Figure 2 Structure diagram of the occluder in an embodiment of the present application;

[0029] Figure 3 Structure diagram of the occluder in an embodiment of the present application;

[0030] Figure 4 Structure diagram of the occluder in an embodiment of the present application;

[0031] Figure 5 Structure diagram of the occluder in an embodiment of the present application;

[0032] Figure 6 Structure diagram of the occluder in an embodiment of the present application;

[0033] Figure 7 Structure diagram of the occluder in an embodiment of the present application;

[0034] Figure 8 Structure diagram of the occluder in an embodiment of the present application;

[0035] Figure 9 Structure diagram of the occluder in an embodiment of the present application;

[0036] Figure 10 Structure diagram of the occluder in an embodiment of the present application;

[0037] Figure 11 Structure diagram of the occluder in an embodiment of the present application;

[0038] Figure 12 Structure diagram of the occluder in an embodiment of the present application; Figure 11 Structure diagram of the occluder in an embodiment of the present application;

[0039] Figure 13 Structure diagram of the occluder in an embodiment of the present application; Figure 11 Structure diagram of the occluder in an embodiment of the present application;

[0040] Figure 14 Structure diagram of the occluder in an embodiment of the present application; Figure 11 Structure diagram of the occluder in an embodiment of the present application;

[0041] Figure 15 Structure diagram of the occluder in an embodiment of the present application; Figure 11 Structure diagram of the occluder in an embodiment of the present application;

[0042] Figure 16 Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application;

[0043] Figure 17 Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application;

[0044] Figure 18 Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application;

[0045] Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application;

[0046] Figure 20 Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application;

[0047] Figure 21 Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application;

[0048] Figure 22 Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application;

[0049] Figure 23 Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application;

[0050] Figure 24 Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application;

[0051] Figure 25 Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application;

[0052] Figure 26 Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application;

[0053] Figure 27 Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application; Figure 26

[0054] Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application; Figure 28

[0055] Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application; Figure 29 Figure 28 Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application;

[0056] Figure 30 Fig. 19(a)~19(d) are schematic diagrams of the locking process of the occluder in another embodiment of the present application;

[0057] Figure 31 ​Structure diagram of the locking part with an inner hole in another embodiment of the present application;

[0058] Figure 32 Structure diagram of the locking part with an inner hole in another embodiment of the present application; Figure 31 Structure diagram of the bending deformation of the connecting rod in the present application;

[0059] Figure 33 Structure diagram of the occlusion device in an embodiment of the present application (the grid structure of the occlusion body is not shown);

[0060] Figure 34 Structure diagram of the occlusion body in an embodiment of the present application;

[0061] Figure 35 Structure diagram of the developing member in an embodiment of the present application;

[0062] Figure 36 Structure diagram of the developing wire in an embodiment of the present application;

[0063] Figure 37 Structure diagram of the high-molecular winding in an embodiment of the present application;

[0064] Figure 38 Structure diagram of the developing wire in another embodiment of the present application;

[0065] Figure 39 Structure diagram of the occlusion device in an embodiment of the present application (the grid structure of the occlusion body is not shown);

[0066] Figure 40 Structure diagram of the occlusion device in another embodiment of the present application (the grid structure of the occlusion body is not shown). DETAILED DESCRIPTION

[0067] In order to make the above objectives, features and advantages of the present application more apparent, specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, a lot of specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be implemented in many different ways other than those described herein, and those skilled in the art can make similar improvements without departing from the spirit of the present application, so the present application is not limited to the specific embodiments disclosed below.

[0068] In the description of the application, it should be understood that the orientation or positional relationship indicated by the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the application and simplifying the description, and does not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the application.

[0069] In addition, the terms "first", "second" are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features defined with "first", "second" can explicitly or implicitly include at least one of the features. In the description of the application, the meaning of "a plurality of" is at least two, such as two, three, etc., unless otherwise explicitly specified and limited.

[0070] In the present application, unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connection", "fixing" and the like should be understood broadly, for example, it can be fixed connection, or detachable connection, or integral; it can be mechanical connection, or electrical connection; it can be directly connected, or indirectly connected through intermediate medium, it can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise explicitly limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0071] In the present application, unless otherwise explicitly specified and limited, the first feature is "on" or "under" the second feature, which can be direct contact between the first and second features, or indirect contact between the first and second features through intermediate medium. Moreover, the first feature "above", "above" and "above" the second feature can be directly above or obliquely above the first feature, or only indicate that the horizontal height of the first feature is higher than that of the second feature. The first feature "below", "below" and "below" the second feature can be directly below or obliquely below the first feature, or only indicate that the horizontal height of the first feature is less than that of the second feature.

[0072] It should be noted that when an element is referred to as being "on" or "connected to" another element, it can be directly on or connected to the other element, or intervening elements can be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element, or intervening elements can be present. The terms "vertical", "horizontal", "upper", "lower", "left", "right", and similar terms as used herein are for the purpose of illustration only and do not indicate the only orientation of the device.

[0073] It should be noted that "proximal end" in the present application refers to the end of the occluder close to the operator during the implantation operation, and "distal end" refers to the end away from the operator; "axial direction" refers to the length direction of the occluder when it is being delivered, and "radial direction" refers to the direction perpendicular to the "axial direction" of the occluder.

[0074] The occluder 100 of the present application is suitable for the treatment of congenital heart disease such as atrial septal defect, ventricular septal defect, patent ductus arteriosus, patent foramen ovale, etc. The common method is to place the occluder 100 at the defect to occlude the defect. For the convenience of understanding, the following examples take patent foramen ovale as an application scenario for illustrative description, and in other examples, the occluder 100 of the present application can be applied to any other suitable application scenario.

[0075] Referring to Figure 1 The occluder 100 includes an occlusion body 10, an occlusion head 20, a plug head 30, and a locking member 40. The occlusion body 10 has an inner cavity and can be deformed under external force, so that the occluder 100 can be radially compressed into a delivery device, and can be released from the delivery device and changed into an expanded shape. The distal end of the occlusion body 10 is connected (e.g., fixedly connected) to the occlusion head 20, and the proximal end of the occlusion body 10 is connected (e.g., fixedly connected) to the plug head 30.

[0076] Exemplarily, the occlusion main body 10 in the natural expansion state without external force, the occlusion main body 10 comprises a waist portion 12 and two disc portions 11, and the two disc portions 11 are connected to the two axial ends of the waist portion 12 respectively. The two disc portions 11 are a proximal disc portion 11a connected to the proximal end of the waist portion 12 and a distal disc portion 11b connected to the distal end of the waist portion 12. The radial dimension of the proximal disc portion 11a and the distal disc portion 11b is greater than the radial dimension (or radial width) of the waist portion 12. The waist portion 12 can be in any suitable shape such as a tube or a bundle, the proximal disc portion 11a and the distal disc portion 11b are in a disc shape, and the cross-sectional shape of the waist portion 12, the proximal disc portion 11a and the distal disc portion 11b can be any suitable shape such as a circle, an ellipse or a polygon. The diameter of the proximal disc portion 11a and the distal disc portion 11b is greater than the diameter of the defect or passage to be occluded. For example, in the treatment of patent foramen ovale, the occlusion main body 10 is stretched in the axial direction (i.e. in the radial compression state) before the occlusion device 100 is implanted, so as to be accommodated in a sheath, the occlusion device 100 is delivered to the foramen ovale through the sheath, and then the occlusion device 100 is released from the sheath to make the occlusion main body 10 expand radially. The waist portion 12 of the occlusion main body 10 passes through the passage of the foramen ovale, and the proximal disc portion 11a and the distal disc portion 11b are located on the two sides of the atrial septum respectively and abut against the side wall of the atrial septum, so as to occlude the foramen ovale passage. It should be noted that due to the different locations of the defects or passages to be occluded, the shapes may also be different, and therefore the expansion shape (or working state) of the occlusion device 100 after implantation may be different from the above-mentioned expansion shape. Figure 1 The shape of the occlusion device 100 in the natural expansion state is different, but no matter what the expansion state is, the radial dimension of the disc portion 11 of the occlusion device 100 is greater than that in the radial compression state.

[0077] In other embodiments, the number of disc portions 11 can be one or more than two. For example, the above-mentioned proximal disc portion 11a can be omitted, and the peg head 30 is connected to the proximal end of the waist portion 12 to bundle the proximal end of the waist portion 12, so that the proximal end of the occlusion main body 10 is closed. For another example, the occlusion device 100 can have three or more disc portions 11, and the number of corresponding waist portions 12 can also be increased to ensure that the two adjacent disc portions 11 are connected by the waist portion 12.

[0078] The above-mentioned occlusion main body 10 can be woven by a plurality of woven wires and / or woven strands to form an occlusion mesh tube with a plurality of mesh holes. In other embodiments, the occlusion main body 10 can be woven by woven wires and / or woven strands to form any other suitable shape, or the occlusion main body 10 can be formed by cutting to form a suitable shape.

[0079] The above woven wires and woven strands can be made of metal or polymer materials. For example, the occlusion body 10 can be formed by mixing a plurality of woven wires and a plurality of woven strands to form a three-dimensional mesh structure with mesh holes. The woven wires are monofilaments, and the diameter of each woven wire ranges from 0.1 mm to 0.5 mm. The woven strands include a plurality of polymer fiber lines, and the plurality of polymer fiber lines are gathered into a strand. The strand can be one or more of a double strand, a triple strand, and a multi-strand. The specification of each woven strand ranges from 50D / 18F to 600D / 144F to balance the mechanical properties and softness requirements. 50D / 18F means that each woven strand contains 18 polymer fiber lines, and the total mass of the 18 polymer fiber lines is 50 denier (D). 600D / 144F has the same meaning and will not be described here. In other embodiments, the specification of each woven strand ranges from 30D / 72F to 100D / 72F or from 50D / 72F to 100D / 72F, and the twist is 1 twist to 30 twists per 10 cm. The mechanical properties and softness requirements are balanced to make the occluder 100 weakly clamp and press the tissue, and weakly wear the tissue, but not fall off from the defect site. The sum of the number of woven wires and the number of woven strands ranges from 36 to 72, and the ratio of the number of woven wires to the number of woven strands ranges from 2:1 to 1:2 to balance the mechanical properties and softness requirements while the radial size of the occluder 100 after stretching is small, so that a smaller diameter delivery sheath can be used for delivery. The material of the woven wire and the woven strand is a material with good biocompatibility. For example, in the present embodiment, polylactic acid is used to make the woven wire and the woven strand. In other embodiments, the material of the woven wire and the woven strand can be polydioxanone, polycaprolactone, polyurethane, polydioxanone, or other degradable polymer materials, or polyethylene terephthalate, or other non-degradable polymer materials, or stainless steel, nickel-titanium, or other metal materials.

[0080] The proximal end of the woven wire and / or the woven strand is gathered and fixed in the plug head 30 to close the proximal end of the occlusion body 10, and the distal end of the woven wire and / or the woven strand is gathered and fixed in the closure head 20 to close the distal end of the occlusion body 10.

[0081] Exemplarily, the head 20 is substantially cylindrical, and can include a receiving layer having an opening at an end thereof, the opening of the receiving layer facing a distal end or a proximal end of the head 20, and the distal end of the braided wire and / or the braided strand can be inserted into the receiving layer through the opening and fixedly connected with the head 20 by welding, hot melting, gluing or the like. The plug 30 is also substantially cylindrical, and also has a receiving layer, the opening of the receiving layer of the plug 30 facing a distal end or a proximal end of the plug 30, and the proximal end of the braided wire and / or the braided strand can be inserted into the receiving layer of the plug 30 through the opening and fixedly connected with the plug 30 by welding, hot melting, gluing or the like. In other embodiments, the head 20 and the plug 30 can have other suitable structures and shapes, and the head 20 and the plug 30 can be connected with the occlusion body 10 in a manner different from the above-described example.

[0082] It can be understood that the structure of the occlusion body 10 is only used as an example and is not a limitation of the present application, and a person of ordinary skill in the art can select any suitable structure of the occlusion body 10 under the inspiration of the present application.

[0083] When the occlusion body 10 is made of a polymer material, the polymer material has low elasticity or no elasticity, so that the forming effect of the occlusion device 100 after being released from the delivery device can not be as expected, and the occlusion device 100 cannot be tightly attached to the two sides of the damaged part, thereby affecting the occlusion effect. Based on this, the occlusion device 100 provided by the present application further includes a locking member 40, a distal end of the locking member 40 being connected with the head 20, for example, the distal end of the locking member 40 can be fixedly connected with the head 20 by welding, hot melting, gluing or the like, and the locking member 40 is at least partially or completely arranged in the inner cavity of the occlusion body 10. The plug 30 includes a locking hole 31 penetrating the inner cavity of the occlusion body 10. The proximal end of the locking member 40 can be inserted into the locking hole 31 and form a locking fit with the locking hole 31, so that the locking member 40 and the plug 30 are locked with each other, and the locking member 40 and the plug 30 remain connected under the action of no artificial external force, so that the occlusion device 100 is better formed and remains in a relatively stable expanded state, thereby being beneficial to maintaining a good occlusion effect of the occlusion device 100.

[0084] Referring to Figure 1 , Figure 2The delivery device matched with the occluder 100 can include a hollow push cable 50 and a control cable 60 arranged in the inner cavity of the push cable 50, the control cable 60 can be axially moved relative to the push cable 50, and the distal end of the control cable 60 can be extended from the distal end opening of the push cable 50. The proximal end of the locking member 40 can be detachably connected with the distal end of the control cable 60, and the peg head 30 can be detachably connected with the distal end of the push cable 50, and the detachable connection manner is not limited to any suitable manner such as threaded connection, clamping, etc. For example, the proximal end of the locking member 40 can include a first thread (e.g., internal thread), the distal end of the control cable 60 can include a second thread (e.g., external thread), and the two are threadedly connected to achieve detachable connection. The peg head 30 includes a third thread (e.g., external thread), and the distal end of the push cable 50 can include a fourth thread (e.g., internal thread), and the two are threadedly connected to achieve detachable connection. It can be understood that the detachable connection manner of the delivery device with the locking member 40 and the peg head 30 can be achieved by any other suitable manner.

[0085] In the state that the occluder 100 is connected with the delivery device, when it is needed to radially compress the occluder 100 (e.g., when it is needed to be bundled into the catheter of the delivery device), the locking state of the locking member 40 and the peg head 30 can be released, and the control cable 60 is pushed to move relative to the push cable 50 towards the distal end, so as to drive the locking member 40 to move relative to the peg head 30 towards the distal end, thereby making the head 20 and the peg head 30 of the occluder 100 move away from each other, the occlusion body 10 is axially elongated to form an elongated tubular structure, and radial compression is achieved. When it is needed to radially expand the occluder 100 (e.g., when it is needed to expand the occluder 100 into a working state), the control cable 60 can be pulled to move relative to the push cable 50 towards the proximal end, so as to drive the locking member 40 to move relative to the peg head 30 towards the proximal end, thereby making the head 20 and the peg head 30 of the occluder 100 move close to each other, the occlusion body 10 is axially compressed, radial expansion is achieved, and when the head 20 and the peg head 30 of the occluder 100 are locked, the expansion state of the occlusion body 10 can be better maintained.

[0086] The technical solutions of the locking member 40 and the cooperating elements related thereto are illustrated below through multiple embodiments.

[0087] First embodiment

[0088] Reference Figures 3 to 5The locking member 40 of the present embodiment comprises a connecting portion 41 and a locking portion 42, and the locking portion 42 is arranged at the proximal end of the locking member 40. The locking hole 31 in the plug head 30 penetrates both ends of the plug head 30 in the axial direction and comprises, in sequence from the proximal end to the distal end, an accommodating hole 311 and a limiting hole 312 which penetrate in the axial direction. The occluder 100 has a first locking state. When in the first locking state, the proximal end of the locking portion 42 can be completely accommodated in the accommodating hole 311, the limiting hole 312 limits the locking portion 42 from being pulled out of the distal end of the locking hole 31, and the locking portion 42 can move in the axial direction in the accommodating hole 311 under the action of an external force and can be deflected in the radial direction to abut against the hole wall of the accommodating hole 311. Since in the first locking state, the limiting hole 312 limits the locking portion 42 from being pulled out of the distal end of the locking hole 31, and the limiting hole 312 is only a part of the locking hole 31 and is located at the distal end of the accommodating hole 311, the locking stroke of the occluder 100 is short, the locking efficiency is high, the mutual locking between the locking members 40 of the plug head 30 can be better maintained, and the expansion state of the occluder 100 can be better maintained to achieve a better occlusion effect. After locking, the proximal end of the locking portion 42 can be completely accommodated in the accommodating hole 311, which can reduce the possibility of thrombosis, disturbance of blood flow and other problems caused by the locking member 40 extending out of the proximal end of the plug head 30, and improve the safety of the occluder 100. In addition, since in the first locking state, the locking portion 42 can move in the axial direction in the accommodating hole 311 under the action of an external force, on the one hand, even if the locking portion 42 is pulled out of the proximal end of the plug head 30 by the control cable 60 during the operation, the locking portion 42 can still move in the axial direction relative to the accommodating hole 311 after implantation, thereby automatically retracting into the accommodating hole 311, and thus the fault tolerance of the operation is improved. On the other hand, the locking member 40 can form displacement compensation with the beating of the heart, improve the service life of the locking member 40 as a whole, and further improve the safety of the occluder 100. For reference Figure 7 、 Figure 8 In addition, since in the first locking state, the locking portion 42 can be deflected in the radial direction to abut against the hole wall of the accommodating hole 311 under the action of an external force, when occluding an inclined defect or passage (for example, the oval foramen usually has an inclined "tunnel"), the locking member 40 will be inclined after the occluder 100 is implanted, thereby driving the locking portion 42 to be inclined and deflected in the radial direction and abut against the hole wall of the accommodating hole 311, so that the locking portion 42 is less likely to move further in the distal direction relative to the accommodating hole 311, and "self-locking" is achieved between the two, thereby further reducing the possibility of the locking portion 42 being pulled out of the distal end of the plug head 30 and improving the firmness of the locking of the locking member 40 with the plug head 30.

[0089] The limiting hole 312 limits the manner in which the locking portion 42 exits the distal end of the locking hole 31. For example, in the present embodiment, the smallest diameter of the limiting hole 312 is smaller than the largest radial dimension (or largest radial width) of the locking portion 42. The locking portion 42 and / or the locking hole 31 has a certain deformation capacity, the locking portion 42 can be pulled through the distal end of the locking hole 31 into the limiting hole 312 by the control cable 60, and when the largest radial dimension of the locking portion 42 passes through the smallest diameter of the limiting hole 312, the locking portion 42 and / or the locking hole 31 elastically deforms to a certain extent, so that the locking hole 31 can be pulled through the limiting hole 312 to enter the accommodating hole 311, and after entering the accommodating hole 311 and being locked, because the smallest diameter of the limiting hole 312 is smaller than the largest radial dimension of the locking portion 42, the limiting hole 312 can limit the locking portion 42, and the force of simple heart beating is not enough to make the locking portion 42 exit the distal end of the plug head 30. For example, the ratio of the largest radial dimension of the locking portion 42 to the smallest diameter of the limiting hole 312 ranges from 1.01 to 1.14, for example, the ratio can be any one of 1.01, 1.02, 1.03, 1.05, 1.07, 1.09, 1.0, 1.1, 1.12, and 1.14. In this way, the axial force required for the locking portion 42 to pass through the limiting hole 312 is moderate, avoiding the problem of locking difficulty, and the locking member 40 and the plug head 30 have a relatively firm locking effect in the first locking state. In other embodiments, the sizes of the locking portion 42 and the limiting hole 312 can be set according to actual needs. It can be understood that the manner in which the limiting hole 312 limits the locking portion 42 from exiting the distal end of the locking hole 31 is not limited to this, for example, the locking portion 42 can have a columnar structure extending in the axial direction, and the limiting hole 312 can be inclined relative to the axial direction. After the locking portion 42 passes through the limiting hole 312 and enters the accommodating hole 311, the limiting hole 312 can also limit the movement of the locking portion 42 in the distal direction.

[0090] The length of the accommodating hole 311 can be greater than or equal to the length of the locking portion 42, for example, the length of the accommodating hole 311 can be 0.5 mm to 1 mm greater than the length of the locking portion 42. In this way, the accommodating hole 311 can completely accommodate the locking portion 42 therein, reducing the risk of slow endothelialization or injury to the myocardial tissue caused by the locking member 40 being too long. In addition, the largest diameter of the accommodating hole 311 can be greater than the largest radial dimension of the locking member 40, and the smallest diameter of the accommodating hole 311 can be greater than the smallest radial dimension of the locking member 40. In this way, in the first locking state, the locking portion 42 can move more smoothly in the accommodating hole 311.

[0091] In this embodiment, the distal end of the connecting portion 41 is connected with the head 20, and the proximal end of the connecting portion 41 is connected with the locking portion 42. For example, the connecting portion 41 comprises a connecting rod 411, the distal end of the connecting rod 411 is fixedly connected with the head 20 by welding, heat melting, gluing or the like, the connecting rod 411 is integrally provided with the locking portion 42, or is fixedly connected with the locking portion 42 by welding, heat melting, gluing or the like. Since the occlusion main body 10 itself can be deformed, when in the first locking state, the connecting portion 41 can be deflected radially to a preset deflection angle under the action of an external force, so as to drive the locking portion 42 to be deflected radially to abut against the hole wall of the accommodating hole 311. The preset deflection angle can be achieved by designing the structure and size of the locking piece 40 and the locking hole 31. The size of the preset deflection angle can be set according to the actual application scene. For example, the "tunnel" of the foramen ovale usually has a relatively fixed inclination direction, and the inclination angle is usually greater than or equal to 7°. Therefore, in the application scene of occluding the patent foramen ovale, the preset deflection angle can be set to be less than or equal to 7°. In this way, the locking portion 42 can abut against the hole wall of the accommodating hole 311 to form "self-locking" with a higher probability after the occluder 100 is implanted. It can be understood that in other application scenes, the preset inclination angle can be set according to actual needs.

[0092] The locking portion 42 includes a guide segment 421 connected to the proximal end of the connecting portion 41 and a main body segment 422 connected to the proximal end of the guide segment 421. Correspondingly, the accommodation hole 311 includes a first hole 3111 and a second hole 3112 in sequence from the proximal end to the distal end, and the second hole 3112 is in communication with the first hole 3111 and the limiting hole 312 at both axial ends. In the direction from the distal end to the proximal end, the radial dimensions of the guide segment 421 and the second hole 3112 gradually increase. By setting the guide segment 421 and the second hole 3112 that cooperate with each other, the locking portion 42 can be guided to enter the limiting hole 312, so that the locking portion 42 can be more smoothly unlocked under the action of artificial external force. The fault tolerance of the surgical operation is improved, and when the occlusion device 100 is not ideal after being implanted and locked, the occlusion device 100 can be unlocked and repositioned and released by operation. In addition, the hole wall profile shape of the second hole 3112 and the outer wall profile shape of the guide segment 421 are matched, both of which have convex curved surfaces with similar curvatures. When the locking portion 42 is tilted in the radial direction after being implanted, the guide segment 421 and the hole wall of the second hole 3112 abut, which also plays a certain limiting role and further enhances the locking effect between the locking member 40 and the locking hole 31. Exemplarily, the ratio of the radial dimension of the main body segment 422 to the radial dimension of the connecting rod 411 ranges from 1.03 to 1.23, for example, the ratio can be any one of 1.03, 10.5, 1.08, 1.09, 1.0, 1.1, 1.15, 1.2, and 1.23, and the ratio of the length of the main body segment 422 to the length of the guide segment 421 ranges from 2 to 4. The guide segment 421 smoothly transitions between the main body segment 422 and the connecting rod 411. Such a setting makes the guide segment 421 not only play a good guiding role, but also play a good limiting role when the locking portion 42 is tilted. In other embodiments, the second hole 3112 can be omitted.

[0093] The main body segment 422 can be a constant-diameter structure (see Figure 5 ) or a non-constant-diameter structure. For example, see Figure 6When the main body section 422 is of a non-constant diameter structure, the radial dimension of the main body section 422 gradually increases in the direction from the distal end to the proximal end, and the taper of the main body section 422 can be controlled to be 2.5%-4%, wherein the taper of the main body section 422 is the percentage of the difference between the radial dimension of the distal end and the radial dimension of the proximal end of the main body section 422 to the length of the main body section 422. In other embodiments, the taper of the main body section 422 can be any other value. The constant diameter structure and the structure with the radial dimension gradually increasing in the direction from the distal end to the proximal end are beneficial to guide the locking portion 42 extending out of the self-locking hole 31 to retract into the accommodating hole 311. In other embodiments, the main body section 422 can be of any other suitable shape and structure. The first hole 3111 can be a constant diameter hole or a non-constant diameter hole. For example, when the first hole 3111 is a non-constant diameter hole, the hole diameter of the first hole 3111 gradually increases in the direction from the distal end to the proximal end. Compared with the non-constant diameter hole, when the first hole 3111 is a constant diameter hole, it is easier to form a "self-locking" with the locking portion 42. For example, the ratio of the hole diameter of the first hole 3111 to the maximum radial dimension of the main body section 422 ranges from 1.015 to 1.15, for example, the ratio can be any one of 1.015, 1.02, 1.03, 1.04, 1.05, 1.06, 1.08, 1.1, 1.12, 1.15. In this way, the main body section 422 can more smoothly move axially or radially in the first hole 3111, and the locking portion 42 and the accommodating hole 311 are more easily formed "self-locking".

[0094] In this embodiment, the radial dimension of the connecting rod 411 is smaller than the hole diameter of the limiting hole 312, and the length of the limiting hole 312 is smaller than the length of the locking portion 42. For example, the ratio of the length of the limiting hole 312 to the length of the locking portion 42 ranges from 1 / 3 to 1 / 2. If the length of the limiting hole 312 is too long, it is difficult for the connecting rod 411 to tilt in the limiting hole 312, or the tilt angle is small or even coaxial with the limiting hole 312, so that the locking portion 42 is difficult to deflect radially and tilt, or the deflection angle is small, and the locking portion 42 is difficult to abut against the inner wall of the accommodating hole 311 to form "self-locking"; if the limiting hole 312 is too short, it is difficult to play a good limiting effect, and the locking portion 42 is easy to come out of the distal end of the plug head 30, thereby causing the unlocking failure of the occluder 100. By reasonably setting the ratio of the length of the limiting hole 312 to the length of the locking portion 42 to be 1 / 3 to 1 / 2, the locking portion 42 is easy to form "self-locking" with the accommodating hole 311, and the limiting hole 312 has a good limiting effect, thereby improving the firmness of the locking of the locking member 40 and the plug head 30.

[0095] Optionally, the limiting hole 312 can have a uniform or non-uniform diameter, and the ratio of the diameter of the limiting hole 312 to the radial dimension of the connecting rod 411 can range from 1.05 to 1.09, so that the connecting rod 411 can be tilted at an appropriate angle in the limiting hole 312, thereby enabling the locking portion 42 to better form a "self-locking" with the accommodating hole 311 while avoiding causing the overall radial dimension of the bolt head 30 to be too large.

[0096] The ratio of the radial dimension of the main body section 422 to the diameter of the limiting hole 312 can range from 1.01 to 1.14, for example, the ratio can be any one of 1.01, 1.02, 1.03, 1.05, 1.07, 1.09, 1.0, 1.1, 1.12, and 1.14. Such a setting can ensure that the locking member 40 and the bolt head 30 have high locking firmness, and the main body section 422 requires an appropriate axial force when passing through the limiting hole 312, avoiding the need for excessive pulling or pushing force during locking or unlocking.

[0097] The locking member 40 can be prepared by heat setting, machining, injection molding, etc. The locking portion 42 and the connecting portion 41 are made of the same high molecular material, for example, nylon, PE, and other non-degradable high molecular materials can be used, and PLLA, PDO, and other degradable high molecular materials can also be used. The locking portion 42 and the connecting portion 41 satisfy one or more of the following conditions:

[0098] The density of the locking portion 42 is less than the density of the connecting portion 41, for example, the ratio of the density of the locking portion 42 to the density of the connecting portion 41 can range from 0.8 to 0.85;

[0099] The hardness of the locking portion 42 is less than the hardness of the connecting portion 41, for example, the ratio of the hardness of the locking portion 42 to the hardness of the connecting portion 41 can range from 0.8 to 0.85;

[0100] The elastic modulus of the locking portion 42 is less than the elastic modulus of the connecting portion 41, for example, the ratio of the elastic modulus of the locking portion 42 to the elastic modulus of the connecting portion 41 can range from 0.8 to 0.85.

[0101] Because the locking portion 42 and the connecting portion 41 satisfy the above conditions, the locking portion 42 has better elasticity or deformation ability, thereby making the locking and unlocking process smoother. In addition, after implantation, the locking portion 42 will form a self-locking with the accommodating hole 311, and the locking portion 42 satisfying the above conditions can have better fatigue resistance.

[0102] In this embodiment, the locking hole 31 can further include a guide hole 313 located at the distal end of the limiting hole 312, the guide hole 313 is in communication with the limiting hole 312, and the diameter of the guide hole 313 gradually increases from the proximal end to the distal end. The guide hole 313 is used to guide the locking part 42 into the limiting hole 312, and the maximum diameter of the guide hole 313 is greater than the maximum radial dimension of the locking part 42 to provide better guiding effect. In other embodiments, the guide hole 313 can be omitted.

[0103] With reference to Figure 9 , for example, the plug head 30 includes an inner sleeve 32 and an outer sleeve 33, the proximal end of the occlusion body 10 is constricted and fixed between the inner sleeve 32 and the outer sleeve 33, the locking hole 31 is located in the inner sleeve 32, and the distal end of the inner sleeve 32 is flush with the distal end of the outer sleeve 33. In other embodiments, the distal end of the inner sleeve 32 is closer to the distal end of the occlusion device 100 than the distal end of the outer sleeve 33. The protruding inner sleeve 32 not only has a better guiding effect, but also can protect the proximal end of the occlusion body 10 to some extent, and can reduce the probability of damage to the occlusion body 10 caused by the mutual friction between the locking part 40 and the braided wire of the proximal end of the occlusion body 10 during the locking and unlocking processes and subsequent implantation process. In other embodiments, the plug head 30 can have only one sleeve, or have more than two sleeves.

[0104] The above-mentioned locking part 42 can be a whole cylindrical structure (see Figure 5 , Figure 6 ), or any other suitable structure. For example, referring to Figure 10 , the locking part 42 includes a cylindrical body 423, an elastic sleeve 424 sleeved and fixed outside the cylindrical body 423, and an attachment pipe 425, a gap is formed between the elastic sleeve 424 and the cylindrical body 423 in the radial direction, so that the elastic sleeve 424 can elastically deform in the radial direction relative to the cylindrical body 423. The cylindrical body 423 can be an equal-diameter structure or a non-equal-diameter structure, the proximal end of the attachment pipe 425 is fixedly connected with the elastic sleeve 424, the attachment pipe 425 is sleeved outside the cylindrical body 423, and the attachment pipe 425 and / or the elastic sleeve 424 are fixedly connected with the cylindrical body 423. The elastic sleeve 424 can be a closed structure in the circumferential direction, or a non-closed structure (for example, a plurality of flaky structures are arranged at intervals in the circumferential direction, and the plurality of flaky structures enclose to form the elastic sleeve 424), and the inner diameter of the elastic sleeve 424 gradually decreases from the proximal end to the distal end, so that the elastic sleeve 424 forms a shape similar to a bell mouth. Since the elastic sleeve 424 has good elasticity, after the occlusion device 100 is implanted, the elastic sleeve 424 can offset part of the stress borne by the locking part 42 through its elastic deformation with the beating of the heart, thereby improving the fatigue resistance and service life of the occlusion device 100. In other embodiments, the above-mentioned attachment pipe 425 can be omitted.

[0105] The locking portion 42 has a radial symmetry structure. For example, Figures 1 to 10 The locking portion 42 in the above embodiment has a radial symmetry structure.

[0106] In other embodiments, the locking portion 42 can have a radial asymmetry structure. Referring to Figures 11 to 15 , the locking portion 42 includes opposite first and second sides 426 and 427 in the radial direction, the first side 426 protrudes radially outward relative to the connecting rod 411, and the second side 427 is located substantially on the same circumferential surface as the connecting rod 411. The first side 426 protrudes radially outward relative to the connecting rod 411 to a greater extent than the second side 427. The second side 427 is located substantially on the same circumferential surface as the connecting rod 411 means that the ratio of the distance from a point on the outer wall of the second side 427 to the extension line of the central axis of the connecting rod 411 to the distance from a point on the outer wall of the connecting rod 411 to the central axis of the connecting rod 411 is in the range of 0.9-1.1. The first side 426 protrudes radially outward relative to the connecting rod 411 to a greater extent than the second side 427 means that the distance from a point on the outer wall of the first side 426 to the extension line of the central axis of the connecting rod 411 is greater than the distance from a point on the outer wall of the second side 427 to the extension line of the central axis of the connecting rod 411, for example, the ratio of the distance from a point on the outer wall of the first side 426 to the extension line of the central axis of the connecting rod 411 to the distance from a point on the outer wall of the second side 427 to the central axis of the connecting rod 411 is in the range of 1.5-2. The locking portion 42 protruding on one side not only has good locking and unlocking effects, but also still has a self-locking function (see Figure 15 ). In particular, after implantation, when the distal end of the connecting portion 41 is offset relative to the proximal end of the connecting portion 41 in the direction of protrusion of the first side 426, if the locking portion 42 protrudes from the proximal opening of the accommodation hole 311, the second side 427 can play a good guiding role and guide the locking portion 42 to retract into the accommodation hole 311 with the beating of the heart, and the first side 426 with a greater protrusion degree can be well abutted against the hole wall of the accommodation hole 311 to form a self-locking (see Figure 15 ).

[0107] Referring to Figure 16Since the "tunnel" of the foramen ovale is inclined in a specific direction, the distal end of the connecting portion 41 can be offset in a direction protruding toward the first side 426 relative to the proximal end of the connecting portion 41 after the occluder 100 is implanted in a specific manner. Exemplarily, a developing member 70 can be arranged on the occluder 100, and the developing member 70 is used to indicate that the occluder 100 is released in a predetermined manner, so that the connecting portion 41 is inclined in a predetermined direction after the occluder 100 is released, and the distal end of the connecting portion 41 is offset in a direction protruding toward the first side 426 relative to the proximal end of the connecting portion 41. Exemplarily, the waist portion 12 of the occluder 100 can be provided with a single developing member 70, which can be located on the same side or the opposite side of the first side 426 in the radial direction, and the control cable 60 is made of a metal material (for example, nickel-titanium alloy, stainless steel, etc.) and can be developed under the developing device. For example, the developing member 70 is located on the same side of the first side 426 in the radial direction, and during the implantation process, the inclined direction of the "tunnel" of the foramen ovale can be known by observing the inclined direction of the control cable 60 entering the inclined "tunnel" of the foramen ovale, that is, the inclined direction of the connecting portion 41 after implantation, and the circumferential position of the occluder 100 is adjusted so that the developing member 70 is located on one side of the control cable 60, and the side is the same side of the offset direction of the distal end of the connecting portion 41 relative to the proximal end of the connecting portion 41 (that is, the upper side in the direction of the first side 426), so that the distal end of the connecting portion 41 is offset in a direction protruding toward the first side 426 relative to the proximal end of the connecting portion 41 after implantation. Figure 16

[0108] In other embodiments, the shape of the developing member 70 can be any suitable shape such as a circle, a water drop shape, a number shape, a triangle shape, etc. For example, the developing member 70 can be provided in a water drop shape, an arrow shape, a triangle shape, etc. which can indicate a direction, and the direction indicated by the developing member 70 can be the same as or opposite to the direction in which the first side 426 protrudes. By providing a shape which can indicate a direction, the developing member 70 can more intuitively and accurately indicate the direction in which the first side 426 protrudes. In other embodiments, the developing member 70 can be any other suitable shape. In other embodiments, the developing member 70 can be omitted.

[0109] In another embodiment, the first side 426 and the second side 427 both protrude radially outward relative to the connecting rod 411, and the first side 426 protrudes radially relative to the connecting rod 411 to a greater extent than the second side 427.

[0110] Referring to Figures 11 to 13 ​, the second side 427 occupies 1 / 3~3 / 4 of the circumference of the locking portion 42, that is, in the cross section passing through the first side 426 and the second side 427, the included angle a between the connecting line of the two ends of the second side 427 and the extension line of the central axis of the connecting rod 411 is 120°~270°, and the first side 426 and the second side 427 complement each other to form the circumferential surface of the locking portion 42. In this way, the first side 426 can better form a "self-locking" with the accommodating hole 311, and the second side 427 can better play a guiding role. In other embodiments, the proportions of the first side 426 and the second side 427 in the circumferential direction of the locking portion 42 can be set as needed.

[0111] The accommodating hole 311 can be a radially symmetrical structure (see Figure 12 ), or a radially asymmetrical structure. The shape of the accommodating hole 311 is adapted to the shape of the locking portion 42, for example, see Figure 14 、 Figure 15 When the accommodating hole 311 is an asymmetrical structure, the accommodating hole 311 includes a first hole wall 3113 and a second hole wall 3114, wherein the first hole wall 3113 protrudes radially outward relative to the hole wall of the limiting hole 312, and the second hole wall 3114 is located on the same circumferential surface as the hole wall of the limiting hole 312. The degree of radial protrusion of the first hole wall 3113 relative to the hole wall of the limiting hole 312 is greater than the degree of radial protrusion of the second hole wall 3114 relative to the hole wall of the limiting hole 312. Alternatively, the first hole wall 3113 and the second hole wall 3114 both protrude radially outward relative to the hole wall of the limiting hole 312, and the degree of radial protrusion of the first hole wall 3113 relative to the hole wall of the limiting hole 312 is greater than the degree of radial protrusion of the second hole wall 3114 relative to the hole wall of the limiting hole 312.

[0112] Second embodiment

[0113] Referring to Figure 17 、 Figure 18 , on the basis of the first embodiment, the occluder 100 further includes a locking sleeve 80 sleeved outside the locking member 40. The proximal end of the locking sleeve 80 is closer to the distal end of the occluder 100 than the proximal end of the locking portion 42. The occluder 100 has a first locking state and a second locking state. When in the first locking state, the locking portion 42 is in locking cooperation with the locking hole 31, and when in the second locking state, the proximal end of the locking sleeve 80 is in locking cooperation with the locking hole 31.

[0114] By setting the locking sleeve 80, the occluder 100 has a first locking state and a second locking state, in which the distance between the head 20 and the plug head 30 is different, so that during the operation, different locking states can be selected according to the length of the defect or passage to be occluded. Therefore, the occluder 100 of the embodiment can adapt to various application scenarios and meet various needs. When in the second locking state, because the locking portion 42 and the proximal end of the locking sleeve 80 form a lock with the locking hole 31, the occluder 100 can also form a double locking effect, thereby improving the locking firmness.

[0115] In one embodiment, the locking sleeve 80 and the locking member 40 can be fixedly connected by welding, bonding, hot melting or any other suitable method. The locking sleeve 80 includes a connecting pipe 81 and a locking pipe 82. The connecting pipe 81 is shaped to fit the connecting rod 411 and is sleeved and fixed on the connecting rod 411. Understandably, in other embodiments, the connecting pipe 81 can be omitted, and the locking pipe 82 is directly connected to the connecting rod 411. The proximal end of the connecting pipe 81 is fixedly connected to the locking pipe 82. The locking pipe 82 is sleeved on the connecting rod 411 and forms a gap in the radial direction between the connecting rod 411. The maximum radial dimension of the locking pipe 82 is greater than the minimum hole diameter of the limiting hole 312, and the maximum radial dimension of the locking pipe 82 is less than the maximum hole diameter of the accommodating hole 311. In the second locking state, the locking pipe 82 is located in the accommodating hole 311, and the locking portion 42 is partially or entirely located in the accommodating hole 311. The limiting hole 312 can limit the locking portion 42 and the locking pipe 82 from moving toward the distal end relative to the locking hole 31, thereby achieving a double locking effect. The locking pipe 82 can be a closed structure in the circumferential direction or a non-closed structure (for example, a plurality of sheet structures are arranged at intervals in the circumferential direction, and the plurality of sheet structures enclose to form the locking pipe 82). From the proximal end to the distal end, the inner diameter of the locking pipe 82 gradually decreases, so that the locking pipe 82 forms a shape similar to a bell mouth. Because the locking pipe 82 has good elasticity, after the occluder 100 is implanted, the locking pipe 82 can offset part of the stress borne by the locking portion 42 through its elastic deformation as the heart beats, thereby improving the fatigue resistance and service life of the occluder 100. In addition, the shape of the bell mouth also allows the locking pipe 82 to retreat from the distal end of the locking hole 31 under the action of artificial axial force to release the lock, thereby improving the fault tolerance of the operation.

[0116] The locking sleeve 80 is axially spaced apart from the locking portion 42, for example, a distance of 2mm to 4mm can be formed between the distal end of the locking tube 82 and the distal end of the locking portion 42. During the locking process, the locking portion 42 can be first pulled into the locking hole 31 by the control cable 60 to form a first locking state. If it is required to further reduce the locking distance between the head 20 and the plug 30, the locking portion 42 can be continuously pulled, so that the locking tube 82 enters the locking hole 31 to form a second locking state. In this way, the operator can adjust the locking distance between the head 20 and the plug 30 according to the need to adapt to the length of different defects or passages. In other embodiments, the spacing distance between the locking tube 82 and the locking portion 42 can be selected according to actual needs.

[0117] When in the first locking state, the locking tube 82 can be located on the distal side of the limiting hole 312, for example, can be located in the guide hole 313 and form a radial gap between the hole wall of the guide hole 313, or located outside the locking hole 31, so that in the first locking state, the locking portion 42 can still be axially movable in the accommodating hole 311 under the action of an external force, and can be radially deflected to abut against the hole wall of the accommodating hole 311, as described in the first embodiment.

[0118] Referring to FIGS. 19(a) to 19(d), in another embodiment, the locking sleeve 80 can be movably connected with the locking member 40. The locking sleeve 80 can slide on the connecting rod 411, and the length of the locking sleeve 80 is less than the length of the connecting rod 411. Referring to FIG. 19(a), during the locking process, the locking portion 42 can be first pulled into the locking hole 31 by the control cable 60 to form a first locking state. If it is required to further reduce the locking distance between the head 20 and the plug 30, the locking portion 42 can be continuously pulled, and after the proximal end of the locking sleeve 80 abuts against the inner wall of the locking hole 31 (see FIG. 19(b)), as the locking portion 42 continues to move proximally, the locking sleeve 80 slides on the connecting rod 411, so that the distal end of the locking sleeve 80 gradually approaches the head 20 until abutting against the proximal end of the head 20 (see FIG. 19(c)). The locking portion 42 is continuously pulled, so that the locking tube 82 enters the locking hole 31 to form a second locking state (see FIG. 19(d)).

[0119] When in the second locking state, the locking portion 42 is axially movable relative to the accommodating hole 311 and the locking sleeve 80 under the action of an external force. Therefore, even if the locking portion 42 is pulled out of the proximal end of the peg 30 by the control cable 60 during the operation, the locking portion 42 can still move axially relative to the accommodating hole 311 after implantation and automatically retract into the accommodating hole 311 with the beating of the heart. In this embodiment, the maximum inner diameter of the locking tube 82 can be greater than the radial dimension of the proximal end of the locking portion 42, so that the locking tube 82 can accommodate part of the locking portion 42 in the second locking state, thereby increasing the axial movement range of the locking portion 42 in the accommodating cavity.

[0120] When in the first locking state, the locking tube 82 can be located on the distal side of the limiting hole 312, for example, can be located in the guide hole 313 and form a radial gap between the hole wall of the guide hole 313, or can be located outside the locking hole 31. In this way, the locking portion 42 can still be axially movable in the accommodating hole 311 under the action of an external force and can be radially deflected to abut against the hole wall of the accommodating hole 311 in the first locking state, as described in the first embodiment. It can be understood that in other embodiments, the locking portion 42 does not necessarily have to be axially movable in the accommodating hole 311 under the action of an external force and can be radially deflected to abut against the hole wall of the accommodating hole 311 in the first locking state.

[0121] Third Embodiment

[0122] With reference to Figure 20 , Figure 21 This embodiment is based on any of the above embodiments. The head 20 includes a first sleeve 21 and a second sleeve 22. The second sleeve 22 is sleeved outside the first sleeve 21, the distal end of the occlusion body 10 is constricted and fixed between the first sleeve 21 and the second sleeve 22, and the inside of the first sleeve 21 includes a lumen 211, the lumen 211 includes a limiting cavity 212, the locking member 40 includes a stabilizing portion 43, the locking member 40 is arranged in the lumen 211, and the maximum radial dimension of the stabilizing portion 43 is greater than the minimum radial dimension of the limiting cavity 212. The limiting cavity 212 is used to limit the stabilizing portion 43 from being pulled out of the proximal end of the limiting cavity 212, thereby improving the connection firmness and reliability of the locking member 40 and the head 20.

[0123] The first sleeve 21 includes an extension tube 214 and a limiting tube 215 from the distal end to the proximal end, and the extension tube 214 is located on the distal side of the limiting tube 215. For example, the proximal end of the extension tube 214 is fixedly connected with the distal end of the limiting tube 215, and the extension tube 214 can be integrally formed with the limiting tube 215 or can be separately manufactured and spliced together. In other embodiments, the extension tube 214 and the limiting tube 215 can also be arranged axially spaced apart, and the first sleeve 21 can also include other elements.

[0124] The inner wall of the extension tube 214 encloses the connecting cavity 213, and the inner wall of the limiting tube 215 encloses the limiting cavity 212. The connecting cavity 213 and the limiting cavity 212 are in communication with each other, and the connecting cavity 213 is closer to the distal end of the occluder 100 than the limiting cavity 212. The locking member 40 further comprises a connecting rod 411 connected to the proximal end of the stabilizing portion 43. The connecting rod 411 is arranged in the limiting cavity 212, and the stabilizing portion 43 is fixedly connected in the connecting cavity 213, that is, the stabilizing portion 43 is fixedly connected with the extension tube 214. Since the limiting cavity 212 limits the stabilizing portion 43, even if the fixed connection between the stabilizing portion 43 and the extension tube 214 loosens, the limiting cavity 212 can well prevent the stabilizing portion 43 from coming out of the proximal end of the head 20, thereby reducing the risk of uncontrolled movement of the locking member 40 after it is separated from the head 20 and damaging the tissue.

[0125] The cross-sectional shape of the stabilizing portion 43 and the extension tube 214 can be any suitable shape such as a circle, an ellipse, a triangle, a quadrilateral, a pentagon, etc. The stabilizing portion 43 and the extension tube 214 can be fixedly connected by welding (e.g., laser welding), hot melting, bonding, etc. The circumferential outer edge (or outer wall) of the stabilizing portion 43 is wholly or partially fixedly connected with the inner wall of the extension tube 214. Exemplarily, with reference to Figure 21 、 Figure 22 During manufacturing, a cylindrical rod (e.g., a cylindrical rod) can be used as a stabilizing portion semi-finished product 43a and placed in the connecting cavity 213, and laser welding is performed along the edge of the stabilizing portion semi-finished product 43a, so that the edge of the stabilizing portion semi-finished product 43a and the inner wall of the extension tube 214 are fused together to form a close fixed connection relationship. The laser welding points can be one or more. When the laser welding points are fewer and the spacing distance is larger, a plurality of connecting units arranged at intervals in the circumferential direction are formed between the stabilizing portion 43 and the extension tube 214. The connecting unit is formed by the fusion of the partial area of the edge of the stabilizing portion semi-finished product 43a and the partial area of the inner wall of the extension tube 214. The partial area of the circumferential outer edge of the stabilizing portion 43 is fixedly connected with the inner wall of the extension tube 214. When the laser welding points are more and dense, the edge of the stabilizing portion semi-finished product 43a can be completely fused and fill the radial gap between the stabilizing portion semi-finished product 43a and the extension tube 214, so that the circumferential outer edge of the stabilizing portion 43 is wholly fixedly connected with the inner wall of the extension tube 214. The outer contour shape of the stabilizing portion 43 matches the shape of the inner wall of the extension tube 214, so as to achieve better connection firmness and reliability.

[0126] The radial dimension of the connecting cavity 213 gradually increases from the proximal end to the distal end, and the radial dimension of the stabilizing portion 43 gradually increases from the proximal end to the distal end. Compared with the structure of the same diameter, the overall outer surface area of the stabilizing portion 43 and the extension tube 214 is larger, the area that can be connected between the stabilizing portion 43 and the extension tube 214 is larger, and the fixed connection between the two is more secure. In particular, when using a welding or hot melting fixed connection method, because the radial dimension of the connecting cavity 213 gradually increases from the proximal end to the distal end, during the welding or hot melting process of the stabilizing portion semi-finished product 43a, the molten part can better follow the guidance of the inner wall of the extension tube 214 and more quickly fill the radial gap between the stabilizing portion semi-finished product 43a and the extension tube 214, which is beneficial to improve the generation efficiency. In other embodiments, the connecting cavity 213 can be a structure of the same diameter, and the stabilizing portion 43 can also be a structure of the same diameter (see Figure 26 ).

[0127] Referring to Figure 20 , Figure 21 , the ratio between the maximum radial dimension of the stabilizing portion 43 and the minimum radial dimension of the limiting cavity 212 is in the range of 1.2-2. The limiting cavity 212 can be a constant-diameter cavity or a non-constant-diameter cavity. This ratio range is more appropriate, on the one hand, it can make the stabilizing portion 43 better play the role of limiting and firm connection, on the other hand, it makes the time and energy required for the stabilizing portion semi-finished product 43 to form the stabilizing portion 43 through welding or hot melting more appropriate, and reduces the risk of causing the woven wire and / or woven strand around the head 20 to break or be damaged during the processing process. In other embodiments, the ratio between the maximum radial dimension of the stabilizing portion 43 and the minimum radial dimension of the limiting cavity 212 can be adjusted as needed.

[0128] In this embodiment, the extension tube 214 extends from the distal end of the second sleeve 22, and the outer diameter of the extension tube 214 gradually increases from the proximal end to the distal end, so that the extension tube 214 as a whole has a trumpet shape. In this way, the extension tube 214 can protect the surrounding elements during the laser welding process, reducing the probability of damage to the surrounding elements during the laser welding process. In particular, when the distal end of the occlusion body 10 extends between the distal ends of the extension tube 214 and the second sleeve 22 and is fixed between the first sleeve 21 and the second sleeve 22, the extension tube 214 can well protect the braided wire and / or braided strand around the distal end of the head 20, reducing the possibility of wire breakage, damage, etc. caused by laser welding. In addition, during the process of collecting the distal end of the occlusion body 10 into the head 20, the end of the braided wire and / or braided strand of the distal end of the occlusion body 10 needs to be placed in the lumen of the second sleeve 22 first, then the first sleeve 21 is inserted into the lumen of the second sleeve 22, and the ends of the braided wire and / or braided strand are located between the outer wall of the first sleeve 21 and the inner wall of the second sleeve 22. The trumpet-shaped extension tube 214 can well limit the end of the braided wire and / or braided strand entering the lumen 211 of the second sleeve 22 from the second sleeve 22 during the insertion of the first sleeve 21, and can also guide the end of the braided wire and / or braided strand to enter the second sleeve 22 more deeply, which is beneficial to improve the connection strength of the distal end of the occlusion body 10 and the head 20. In other embodiments, the distal end of the extension tube 214 can be flush with the distal end face of the second sleeve 22 or closer to the proximal end of the occluder 100 than the distal end face of the second sleeve 22.

[0129] In some embodiments, the entire extension tube 214 can be located outside the second sleeve 22. In some embodiments, referring to Figure 20 , the extension tube 214 can include an internal segment 2141 located in the lumen 211 of the second sleeve 22, and an extension segment 2142 extending out of the distal end of the second sleeve 22. The outer diameter of the internal segment 2141 gradually increases from the proximal end to the distal end, and therefore, the radial dimension of the lumen 211 of the second sleeve 22 gradually increases from the proximal end to the distal end in the region where the second sleeve 22 cooperates with the extension tube 214. The extension segment 2142 can protect the braided wire and / or braided strand around the head 20, and the internal segment 2141 can better fix and limit the distal end of the occlusion body 10, thereby improving the connection strength of the occlusion body 10 and the head 20. In other embodiments, the extension tube 214 can be omitted.

[0130] The maximum radial dimension of the extension tube 214 (i.e., the maximum outer diameter of the extension tube 214) is less than the maximum radial dimension of the second sleeve 22 (i.e., the maximum outer diameter of the second sleeve 22), for example, the ratio of the maximum radial dimension of the extension tube 214 to the maximum radial dimension of the second sleeve 22 can range from 0.4 to 0.8. In other embodiments, the sizes of the extension tube 214 and the second sleeve 22 can be selected as needed.

[0131] With reference to Figure 21 In the present embodiment, the distal end of the stabilizing portion 43 is closer to the proximal end of the occluder 100 than the distal end of the extension tube 214, so that the extension tube 214 can better protect the braided wire and / or braided strand around the head 20. In other embodiments, the distal end of the stabilizing portion 43 can be flush with the distal end of the extension tube 214.

[0132] With reference to Figure 21 , Figure 22 In the present embodiment, the distal end of the stabilizing portion 43 is closer to the distal end of the occluder 100 than the distal end of the second sleeve 22. This arrangement makes it easier and more accurate to perform welding and hot melting operations on the distal end of the stabilizing portion semi-finished product 43a during the process of locking the locking member 40 and the head 20, thereby improving the process efficiency. In other embodiments, the distal end of the stabilizing portion 43 can be flush with the distal end of the second sleeve 22 or closer to the proximal end of the occluder 100 than the distal end of the second sleeve 22.

[0133] The stabilizing portion 43 can be a one-piece structure or a split structure.

[0134] Illustratively, with reference to Figure 21 , Figure 22 The stabilizing portion 43 is a one-piece structure formed by welding or hot melting the stabilizing portion semi-finished product 43a having the same diameter as the connecting rod 411.

[0135] In another embodiment, with reference to Figure 23 The stabilizing portion 43 includes a stabilizing unit 431 and an attachment tube 432, the attachment tube 432 is sleeved outside the stabilizing unit 431 and located in the extension tube 214, and the extension tube 214 and the stabilizing unit 431 are fixedly connected through the attachment tube 432. The stabilizing unit 431 can be a cylindrical structure having the same radial dimension as the connecting rod 411, or can be any other suitable structure in other embodiments, and the radial dimension of the stabilizing unit 431 can be different from that of the connecting rod 411. The inner wall of the attachment tube 432 and the outer wall of the stabilizing unit 431 are fixedly connected by welding, hot melting, bonding or the like, and the outer wall of the attachment tube 432 is fixedly connected with the inner wall of the extension tube 214. For example, laser welding, with reference to Figure 23 , Figure 24In the manufacturing process, the stabilizing unit 431 is first placed in the connecting cavity 213, and then the attachment pipe semi-finished product 432a is sleeved outside the stabilizing unit 431, wherein the attachment pipe semi-finished product 432a is a sleeve pipe with equal diameters, and laser welding is performed along the inner and outer edges of the attachment pipe semi-finished product 432a, so that the outer edge of the attachment pipe semi-finished product 432a and the inner wall of the extension pipe 214 are fused together, and the inner edge of the attachment pipe semi-finished product 432a and the outer wall of the stabilizing unit 431 are fused together, thereby forming a close and fixed connection. The laser welding points can be one or more. When the laser welding points are fewer and the interval distance is larger, the fusion between the attachment pipe 432 and the extension pipe 214 and between the attachment pipe 432 and the stabilizing unit 431 forms multiple connection units arranged at intervals in the circumferential direction. The circumferential outer edge part of the attachment pipe 432 is fixedly connected to the inner wall of the extension pipe 214, and the circumferential inner edge part of the attachment pipe 432 is fixedly connected to the outer wall of the stabilizing unit 431. When the laser welding points are more and closer, the inner and outer edges of the attachment pipe 432 are completely fused and fill the radial gap between the stabilizing unit 431 and the extension pipe 214, so that the circumferential outer edge of the attachment pipe 432 is fixedly connected to the inner wall of the extension pipe 214, and the circumferential inner edge of the attachment pipe 432 is fixedly connected to the outer wall of the stabilizing unit 431. The outer contour shape of the attachment pipe 432 matches the shape of the inner wall of the extension pipe 214, for example, forming a similar circular truncated cone or a truncated cone, so as to achieve better connection firmness and reliability.

[0136] The maximum radial dimension of the attachment pipe 432 is greater than the minimum radial dimension of the limiting cavity 212, so that the limiting cavity 212 can well limit the stabilizing part 43 from being pulled out from the proximal end of the limiting cavity 212, and the locking piece 40 can be firmly and stably connected to the head 20.

[0137] Optionally, the minimum inner diameter of the attachment pipe 432 is greater than the maximum radial dimension of the connecting rod 411. When the locking piece 40 is made of a high polymer material, since the high polymer material has a certain light transmittance, in the process of welding the stabilizing part semi-finished product 43a and the attachment pipe semi-finished product 432a by laser, the laser can penetrate into the connecting rod 411 through the stabilizing part 43, thereby damaging the connecting rod 411. By arranging the attachment pipe 432, and the minimum inner diameter of the attachment pipe 432 being greater than the maximum radial dimension of the connecting rod 411, in the laser welding process, the laser spot is directly incident on the attachment pipe 432 rather than the stabilizing unit 431 coaxial and equal in diameter with the connecting rod 411, so that the laser beam cannot or has a lower probability of entering the connecting rod 411, thereby reducing the possibility of damaging the connecting rod 411. In other embodiments, the sizes of the attachment pipe 432 and the connecting rod 411 can be adjusted according to actual needs.

[0138] Referring to Figure 25Optionally, the occluder 100 further comprises a developing ring 433, which is sleeved and fixed outside the stabilizing part 43, or embedded in the stabilizing part 43. The developing ring 433 can be made of metal materials such as gold and platinum, or non-metallic materials, for example, by doping sodium bromide, sodium iodide, iodine, barium sulfate, etc. into non-metallic materials. The developing ring 433 can be made by cutting, casting, turning, etc., or woven or wound by filaments. The maximum radial dimension of the developing ring 433 is greater than the minimum radial dimension of the limiting cavity 212 (refer to Figure 20 ), and the limiting cavity 212 can limit the developing ring 433 from escaping from the proximal end of the limiting cavity 212. The developing ring 433 not only has good developing effect, but also assists the stabilizing part 43 to further enhance the limiting and connection firmness. The developing ring 433 can be closer to the proximal end of the occluder 100 than the distal end of the stabilizing part 43, so as to reduce the risk of the developing ring 433 separating from the stabilizing part 43. In other embodiments, the developing ring 433 can be arranged at any other suitable position of the stabilizing part 43.

[0139] Refer to Figure 26 , Figure 27 In another embodiment, the locking member 40 can be movably connected with the head 20, and the locking member 40 can move axially relative to the head 20. The locking member 40 can further comprise a limiting part 44 connected with the connecting rod 411, and the limiting part 44 and the stabilizing part 43 are arranged axially spaced apart, and the limiting part 44 is located on the proximal end side of the head 20. The limiting part 44 can have a ring structure or any other suitable structure. The maximum radial dimension of the limiting part 44 is greater than the minimum radial dimension of the limiting cavity 212 (refer to Figure 20 ), and the limiting cavity 212 is used to limit the limiting part 44 from escaping from the distal end of the limiting cavity 212, and the limiting part 44 and the stabilizing part 43 cooperate to limit the axial movement range of the locking member 40 relative to the head 20. Since the locking member 40 can be movably connected with the head 20, the locking member 40 can displace appropriately with the beating of the heart, which can reduce the stress on the locking member 40 in the body to some extent, thereby improving the service life of the locking member 40. The cooperation of the limiting part 44 and the stabilizing part 43 to limit the axial movement range of the locking member 40 can prevent the distal end of the locking member 40 from extending too much beyond the distal end of the head 20, and thus improve the locking safety and reliability of the occluder 100.

[0140] The axial distance between the limiting portion 44 and the stabilizing portion 43 is greater than the length of the first sleeve 21. Exemplarily, the ratio between the axial distance between the limiting portion 44 and the stabilizing portion 43 and the length of the first sleeve 21 ranges from 1.1 to 1.5. By reasonably setting the axial distance between the limiting portion 44 and the stabilizing portion 43, the moving range of the locking member 40 relative to the head 20 is more appropriate. The locking member 40 will not extend too much beyond the distal end of the head 20, thereby affecting the surrounding blood flow or injuring the surrounding tissue. Also, the locking member 40 will not be deformed or have a limited displacement range due to a too small moving range, thereby reducing or eliminating the ability of the locking member 40 to withstand stress.

[0141] With reference to Figure 28 Optionally, in some embodiments, the connecting rod 411 has a uniform radial dimension, and the limiting cavity 212 also has a uniform radial dimension. The radial dimension of the limiting cavity 212 is greater than the radial dimension of the connecting rod 411. In this way, the connecting rod 411 has a certain radial activity space in the limiting cavity 212. Regardless of whether the stabilizing portion 43 is fixedly connected or movably connected with the head 20, the connecting rod 411 can have a certain degree of radial activity relative to the limiting cavity 212 (see Figure 29 When the position to be occluded is an inclined defect or passage (for example, the oval foramen usually has an inclined "tunnel"), the locking member 40 can better adapt to the inclined defect or passage after the occluder 100 is implanted.

[0142] Exemplarily, the ratio between the radial dimension of the limiting cavity 212 and the radial dimension of the connecting rod 411 ranges from 1.2 to 1.5. This size range is more appropriate, not only making the connecting rod 411 more smoothly radially active in the limiting cavity 212, but also making the connecting rod 411 retain better mechanical strength.

[0143] With reference to Figures 30 to 32 Optionally, in some embodiments, the above-mentioned locking member 40 further comprises an inner hole 45, which extends in the axial direction.

[0144] Exemplarily, with reference to Figure 13 In some embodiments, the inner hole 45 can pass through the entire stabilizing portion 43 and the connecting rod 411. Since the connecting rod 411 is not directly connected with the head 20, but is connected with the head 20 through the stabilizing portion 43, the setting of the inner hole 45 makes the stabilizing portion 43 and the connecting rod 411 have better elasticity. When the occluder 100 is locked in a limit state (for example, when the inclined angle of the passage to be occluded is large), the locking member 40 is bent and deformed due to the extrusion of the myocardial tissue and the pulling of the delivery device. The setting of the inner hole 45 makes the locking member 40 be able to elastically bend and deform to a certain extent. By deformation, the stress of the locking member 40 in the locking process and the subsequent use process is offset or reduced, thereby improving the fatigue life of the locking member 40.

[0145] Referring to Figure 31 In some embodiments, the inner hole 45 extends through the stabilizing portion 43 in the axial direction and continues to extend proximally to the connecting rod 411, but only extends in a partial axial section of the connecting rod 411. The inner hole 45 extending in the partial axial section of the connecting rod 411 can make the distal section of the locking member 40 have better elasticity, while the rest of the connecting rod 411 remains solid structure, thus having good mechanical strength.

[0146] In some embodiments, the inner hole 45 extends in a partial axial section of the connecting rod 411, and the distal end of the inner hole 45 can extend to the stabilizing portion 43, but is closer to the proximal end of the occluder 100 than the distal end of the stabilizing portion 43. In this way, the distal end of the inner hole 45 is closed, that is, the distal end of the stabilizing portion 43 is closed, which not only improves the strength of the stabilizing portion 43 itself, but also makes the distal end of the sealing head 20 more easily covered by the endothelium, which is conducive to improving the endothelialization speed.

[0147] Optionally, the ratio of the diameter of the inner hole 45 to the radial dimension of the connecting rod 411 can be in the range of 1 / 3 to 1 / 2. In this way, the locking member 40 has an axial section of the inner hole 45 that has both better elasticity and mechanical strength. In other embodiments, the sizes of the inner hole 45 and the connecting rod 411 can be set according to actual needs.

[0148] For the embodiments in which the inner hole 45 extends in a partial axial section of the connecting rod 411, the proximal end of the inner hole 45 can be closer to the proximal end of the occluder 100 than the proximal end of the sealing head 20. Referring to Figure 32 When the connecting rod 411 is bent and deformed, the connecting rod 411 is easily subjected to greater stress at the proximal end of the sealing head 20. By providing the inner hole 45 to pass through the proximal end of the sealing head 20, the area of the connecting rod 411 passing through the proximal end of the sealing head 20 has better elasticity, thus being able to well buffer the stress in this area.

[0149] Optionally, the ratio of the length of the inner hole 45 to the length (or axial height) of the sealing head 20 is in the range of 0.5 to 2, which can make the locking member 40 have good elasticity and mechanical strength. In other embodiments, the lengths of the inner hole 45 and the sealing head 20 can be set according to needs.

[0150] Fourth embodiment

[0151] Since the occlusion main body 10 is made of the braided wire 101 and the braided strand 102 mixedly woven from degradable materials, the degradable materials usually cannot be developed in the contrast equipment, and the doctor cannot identify the occluder under DSA, which brings difficulties to the interventional operation process. In order to better help the doctor to judge the position and release form of the occluder 100 implanted in the operation, the present embodiment is based on any of the above embodiments, and the occluder 100 comprises a developing member 70.

[0152] With reference to Figure 33 , Figure 34 The occlusion body 10 of the present embodiment is formed by interlacing the woven material (woven filaments 101 and woven strands 102) of two extension directions (first extension direction and second extension direction) to form a net tube and then heat setting. The interlacing method of the woven material can be plain weave or twill weave, etc. to form multiple rows of intersection points and multiple rows of net holes 106. The net holes 106 are enclosed by the woven material, and the intersection points are formed by the interlacing of the woven material. Due to the interlacing of the woven filaments 101 and the woven strands 102, there are multiple intersection points, including: woven filament intersection points 103 formed by the interlacing of woven filaments 101 of different extension directions, mixed intersection points 104 formed by the interlacing of woven filaments 101 and woven strands 102 of different extension directions, and strand intersection points 105 formed by the interlacing of woven strands 102 of different extension directions.

[0153] With reference to Figures 33 to 35 In the present embodiment, the developing member 70 can be arranged on the intersection points of the occlusion body 10 to reduce the risk of displacement of the developing member 70 due to scratching by the catheter port of the delivery device during sheathing and unsheathing. Exemplarily, the developing member 70 can be arranged only on the woven filament intersection points 103. Since the woven filaments 101 are monofilaments with better support performance, the developing member 70 arranged on the woven filament intersection points 103 can better deform the woven filaments 101 and drive the occlusion body 10 to expand during the transition of the occlusion body 10 from the radially compressed state to the expanded state, and the developing member 70 arranged on the woven filament intersection points 103 is less likely to hinder the expansion of the occlusion body 10.

[0154] With reference to Figures 35 to 37The developing element 70 includes a developing wire 71 and a degradable high molecular thread 72. The developing wire 71 is wound and fixed on the braided wire intersection 103. The developing wire 71 can be made of metal materials such as gold and platinum, or can be made of non-metallic materials, for example, by doping sodium bromide, sodium iodide, iohexol, iodine, barium sulfate and other materials into non-metallic wire. There are various ways to wind and fix the developing wire 71 on the braided wire intersection 103. For example, the developing wire 71 includes a wire body 711 and wire heads 712 at both ends of the wire body 711. The wire body 711 is wound around the braided wire intersection 103 for multiple turns (for example, 2-6 turns) to form a spiral pipe structure 71a. The wire body 711 in the spiral pipe structure 71a is tightly fitted, the braided wire intersection 103 is located in the inner cavity of the spiral pipe structure 71a, and the two wire heads 712 are respectively located at both ends of the spiral pipe structure 71a and tightly press against the spiral pipe structure 71a. In this way, the developing wire 71 can be more smoothly and tightly wound on the braided wire intersection 103, and is not easy to move, and the wire head 712 is also not easy to stick out and damage the tissue. For another example, the wire body 711 is wound around the braided wire intersection 103 for multiple turns (for example, 2-6 turns) to form a spiral pipe structure 71a. The wire body 711 in the spiral pipe structure 71a is tightly fitted, and the two wire heads 712 respectively converge from both ends of the spiral pipe structure 71a to one end of the spiral pipe structure 71a and are knotted to form a developing knot 713. The developing knot 713 is located at the end of the spiral pipe structure 71a, which refers to the end in the length direction of the spiral pipe structure 71a. The developing knot 713 makes the shape of the developing wire 71 wound to have a larger overall volume, which can develop more clearly. After the blood flows in, the small gap in the developing knot 713 can better promote blood coagulation, so that the developing element 70 can be endothelialized faster. In other embodiments, the developing wire 71 can be wound on the braided wire intersection 103 in other suitable ways such as cross winding.

[0155] The high polymer wrapping wire 72 is fixed outside the developing wire 71 and completely wraps the developing wire 71. The high polymer wrapping wire 72 can be a fiber strand. The high polymer wrapping wire 72 can be made of degradable high polymer materials such as polylactic acid, poly-p-dioxanone, polycaprolactone, polyurethane, poly-p-dioxanone, or made of non-degradable high polymer materials such as polyethylene terephthalate, polytetrafluoroethylene. The high polymer wrapping wire 72 is wrapped outside the developing wire 71. There are various wrapping methods. For example, the high polymer wrapping wire 72 includes a wire body 721 and wire heads 722 at both ends of the wire body 721. The wire body 721 is wrapped around the developing wire 71 to completely wrap the developing wire 71 and the intersection 103 of the braided wire inside the developing wire 71. The two wire heads 722 are continuously knotted to form one or more wire knots 723. The number of wire knots 723 can be 1-4, for example, the number can be any one of 1, 2, 3, and 4. The plurality of wire knots 723 can help the high polymer wrapping wire 72 to be firmly tied, and avoid the high polymer wrapping wire 72 from being scattered. In addition, since the fiber strand is used, the inside of the wire knot 723 has more pores, which can better promote the endothelialization process of the developing member 70.

[0156] The embodiment wraps the high polymer wrapping wire 72 on the surface of the developing wire 71. On the one hand, the volume of the developing member 70 can be increased, so that the developing member 70 has a better reflection effect under ultrasonic waves, which helps to better grasp the position of the occluder 100 in the ultrasonic guided patent foramen ovale intervention. On the other hand, the high polymer wrapping wire 72 has good elasticity and flexibility, so that the developing member 70 with increased volume can better enter and exit the catheter of the delivery device. In addition, the high polymer wrapping wire 72 wrapped outside the developing wire 71 has a good endothelialization promoting effect, which can quickly endothelialize the developing member 70 and prevent the problem of the developing member 70 falling off due to the degradation of the braided material around the developing member 70.

[0157] After the high polymer wrapping wire 72 wraps the developing wire, the developing member 70 has a specific shape, which includes one or more of spherical, cocoon-shaped, water-drop-shaped, and conical. Among them, the spherical and cocoon-shaped developing members 70 have a smoother surface and more uniform size in each direction, so they not only have better elasticity, but also have better reflection effect under ultrasonic waves. In other embodiments, the developing member 70 can also be any other suitable shape.

[0158] Reference Figure 33In the embodiment, the waist portion 12 is provided with the above-mentioned developing member 70, which is referred to as a first developing member 70a. The first developing member 70a can help the waist portion 12 to be better anchored in the long and narrow "tunnel" of the foramen ovale. Preferably, the first developing member 70a is provided only on one radial side of the waist portion 12. Since the first developing member 70a has a large volume, if a plurality of first developing members 70a are circumferentially provided, the waist portion 12 will have an excessively large size and cannot be deformed flexibly, so that the waist portion 12 cannot well adapt to the long and inclined "tunnel" of the foramen ovale. In addition, the control cable 60 (see Figure 2 ) detachably connected to the locking member 40 of the occlusion device 100 is made of a metal material (for example, nickel-titanium alloy, stainless steel, etc.) and can be developed under a developing device. During implantation, the first developing member 70a and the control cable 60 cooperate to indicate the circumferential deflection of the occlusion device 100. In other embodiments, the waist portion 12 can be provided with a plurality of first developing members 70a or other developing points not wrapped with the high polymer thread 72.

[0159] In the embodiment, the first occlusion disc 11a and the second occlusion disc 11b are each provided with the above-mentioned developing member 70. The developing member 70 on the first occlusion disc 11a is referred to as a second developing member 70b, and the developing member 70 on the second occlusion disc 11b is referred to as a third developing member 70c. Exemplarily, the two second developing members 70b are each provided on or near the edge of the first occlusion disc 11a and are symmetrically arranged in the radial direction. The two third developing members 70c are each provided on or near the edge of the second occlusion disc 11b and are symmetrically arranged in the radial direction.

[0160] The first developing member 70a, the second developing member 70b and the third developing member 70c can have the same structure and manufacturing method or different structures and manufacturing methods.

[0161] In some embodiments, the first developing member 70a, the second developing member 70b and the third developing member 70c have the same structure and manufacturing method. For example, with reference to Figure 33 、 Figure 36 、 Figure 37, the wire body 711 of the developing wire 71 is wound around the woven wire intersection 103 along the transverse direction of the woven wire intersection 103 (i.e. the circumferential direction of the occluder 100) to form a spiral pipe structure 71a, the spiral coils of the spiral pipe structure 71a are closely arranged along the longitudinal direction, one wire head 712 of the developing wire 71 extends from one end of the spiral pipe structure 71a to the other end to converge with the other wire head 712 of the developing wire 71 and form a developing knot 713, so that the developing knot 713 is located at the end of the spiral pipe structure 71a, i.e. in the mesh hole 106 adjacent to the woven wire intersection 103. The wire body 721 of the high polymer thread 72 is also wound around the spiral pipe structure 71a and the developing knot 713 along the transverse direction to completely wrap them, and the two thread heads 722 are continuously knotted to form a plurality of thread knots 723. Among them, the two thread heads 722 can be knotted at the longitudinal end of the developing member 70 (i.e. the end in the direction perpendicular to the transverse winding direction), and the thread knot 723 and the developing knot 713 can be located at the same end or at different ends, i.e. the thread knot 723 and the developing knot 713 are located in the same mesh hole 106 or in two mesh holes 106 adjacent to the woven wire intersection and longitudinally opposite. The wire body 711 and the wire body 721 are wound along the transverse direction, and such arrangement can make the woven wire 101 corresponding to the woven wire intersection 103 wrapped by the developing member 70 better conform to the deformation during the radial shrinkage of the occluder 100, so that the sheath can be better retracted. In addition, the developing knot 713 is located at the end of the spiral pipe structure 71a, and the thread knot 723 is also located at the longitudinal end of the developing member 70. On the one hand, one wire head 712 extends from one end of the spiral pipe structure 71a to the other end to converge with the other wire head 712 of the developing wire 71 and form a developing knot 713, so that the spiral coils of the spiral pipe structure 71a are closely adhered to each other along the longitudinal direction, which not only prevents the spiral pipe structure 71a from deforming and protruding, but also improves the developing effect of the developing wire 71; on the other hand, the developing knot 713 is located at the end of the spiral pipe structure 71a and the thread knot 723 is located at the longitudinal end of the developing member 70, which can reduce the possibility of the developing knot 713 and the thread knot 723 being scratched and damaged by the catheter port and the internal components (e.g. the locking member 40) of the occluder 100 during the sheath retraction and sheath extension, and can reduce the risk of the developing knot 713 protruding and damaging the tissue.

[0162] In other embodiments, the structures and manufacturing methods of the first developing member 70a, the second developing member 70b and the third developing member 70c can be different. For example, referring to Figure 33 、 Figure 36 、 Figure 37In the first developing member 70a, the wire main bodies 711 of the developing filaments 71 are all wound in the transverse direction to form a spiral tube structure 71a at the woven filament intersection points 103, and the spiral turns of the spiral tube structure 71a are closely arranged in the longitudinal direction. One of the filament heads 712 of the developing filaments 71 extends from one end of the spiral tube structure 71a to the other end to converge with the other filament head 712 of the developing filaments 71 and form a developing knot 713 by knotting, so that the developing knot 713 is located at the end of the spiral tube structure 71a, i.e., in the mesh 106 adjacent to the woven filament intersection point 103. The wire main bodies 721 of the high-molecular polymer winding wires 72 are also wound in the transverse direction to the spiral tube structure 71a and the developing knot 713 to completely wrap them, and the two wire heads 722 are continuously knotted to form a plurality of wire knots 723. Among them, the two wire heads 722 can be knotted at the longitudinal end of the developing member 70, and the wire knots 723 and the developing knot 713 can be located at the same end or at different ends, i.e., the wire knots 723 and the developing knot 713 are located in the same mesh 106, or are located in two meshes 106 adjacent to and longitudinally opposite to the woven filament intersection point 103. For reference Figure 33 、 Figure 38, the wire body 711 of the developing wire 71 and the wire body 721 of the polymer wrapping wire 72 are longitudinally wound around the braided wire intersection point 103, so that the included angle of the braided wire intersection point 103 in the longitudinal direction can be unfolded to be large enough. In this way, the deformation of the braided wire 101 connected with the developing member 70 during the unfolding process of the occluder 100 can be avoided, and the risk of forming defects at the braided wire intersection point 103 connected with the developing member 70 due to the insufficient unfolding of the included angle of the braided wire intersection point 103 in the longitudinal direction can be reduced. In addition, the wire body 711 of the developing wire 71 and the wire body 721 of the polymer wrapping wire 72 are longitudinally wound around the braided wire intersection point 103, so that the spiral coils of the spiral tube structure 71a are closely arranged in the transverse direction and are not easily deformed and poked out by the catheter of the delivery device during the sheathing and unsheathing processes. Furthermore, one of the wire heads 712 extends from one end of the spiral tube structure 71a to the other end to converge with the other wire head 712 of the developing wire 71 and is knotted, so that the wire head 712 can effectively reduce the risk of the developing knot 713 being displaced and poked out due to the catheter.

[0163] In the present embodiment, the first occluding disc 11a and the second occluding disc 11b are radially symmetrical structures. Referring to FIG. 1, the first occluding disc 11a and the second occluding disc 11b are radially symmetrical structures. The first occluding disc 11a and the second occluding disc 11b are respectively connected with the first developing member 70a and the second developing member 70b through the first connecting wire 101a and the second connecting wire 101b. The first developing member 70a and the second developing member 70b are respectively connected with the third developing member 70c through the third connecting wire 101c. Figure 39In other embodiments, the first occlusion disc 11a or the second occlusion disc 11b can be eccentric, i.e. the geometric center of the first occlusion disc 11a or the second occlusion disc 11b does not coincide with the geometric center of the waist 12, and there is an offset. The foramen ovale usually has an inclined "tunnel", and for some long-tunnel type patent foramen ovale cases, the radially symmetrical occlusion disc 11 can have a phenomenon of edge lifting. The use of an eccentric occlusion disc 11 can reduce the occurrence of this edge lifting phenomenon. The first visualization member 70a can be arranged on the side closer to the geometric center of the eccentric occlusion disc 11, and the catheter of the delivery device and the control cable 60 (see Figure 2 ) enter the inclined "tunnel" of the foramen ovale, and can follow the corresponding inclination of the "tunnel". The control cable 60 with the visualization effect can cooperate with the first visualization member 70a to indicate the direction of the eccentricity of the occlusion disc 11.

[0164] Optionally, in some embodiments, the volume of the first visualization member 70a can be greater than that of the second visualization member 70b and the third visualization member 70c, so as to improve the anchoring effect of the first visualization member 70a in the waist 12. In other embodiments, the volumes of the first visualization member 70a, the second visualization member 70b and the third visualization member 70c can be equal.

[0165] Optionally, in some embodiments, the above-mentioned high-molecular twisted wire 72 can be made of a material with liquid absorption and expansion function (for example, polyurethane foaming material, polyvinyl alcohol foaming material, poly(2-hydroxymethyl propionate) hydrogel, etc.), or can be embedded with a material with liquid absorption and expansion function, so that the high-molecular twisted wire 72 has the function of liquid absorption and expansion. After expansion, the volume of the visualization member 70 as a whole increases. In particular, when the high-molecular twisted wire 72 of the first visualization member 70a has the function of liquid absorption and expansion, the first visualization member 70a can play a certain flow resistance effect after implantation, and can play a better anchoring effect.

[0166] Fifth embodiment

[0167] Reference Figure 40 On the basis of any of the above embodiments, the occlusion device 100 further comprises two connecting wires 73, namely a first connecting wire 73a and a second connecting wire 73b, which are radially symmetrically arranged in the occlusion main body 10. The first connecting wire 73a is connected in series with one second visualization member 70b, the first visualization member 70a and the third visualization member 70c on one radial side of the occlusion main body 10, and the second connecting wire 73b is connected in series with one second visualization member 70b and the third visualization member 70c on the other radial side of the occlusion main body 10.

[0168] The connecting wire 73 has a developing function, can be made of a shape memory alloy material such as nickel titanium, and is attached with a developing metal material such as gold or platinum, or can be made of a non-metal material, for example, barium sulfate, sodium bromide, sodium iodide, iodixanol, iodine, and the like.

[0169] The first occlusion disc 11a includes a first distal disc 111, a first proximal disc 112, and a first ridge 113 connecting the first proximal disc 112 and the first distal disc 111, and the first distal disc 111 and the first proximal disc 112 each extend in a substantially radial direction to form a disc shape, the outer edge of the first distal disc 111 is connected to the distal end of the first ridge 113, and the proximal end of the first ridge 113 is connected to the outer edge of the first proximal disc 112. The second occlusion disc 11b includes a second proximal disc 114, a second distal disc 115, and a second ridge 116 connecting the second proximal disc 114 and the second distal disc 115, and the second distal disc 115 and the second proximal disc 114 each extend in a substantially radial direction to form a disc shape, the outer edge of the second distal disc 115 is connected to the distal end of the second ridge 116, and the proximal end of the second ridge 116 is connected to the outer edge of the second proximal disc 114. It should be noted that in the present embodiment, the overall shape and radial size of the first occlusion disc 11a and the second occlusion disc 11b are different, and in other embodiments, the shape and radial size of the first occlusion disc 11a and the second occlusion disc 11b can be the same. The weaving method and material of the waist portion 12 are basically the same as those of the first occlusion disc 11a and the second occlusion disc 11b. It can be understood that in other embodiments, the weaving method and material of the waist portion 12 can also be different from those of the first occlusion disc 11a and the second occlusion disc 11b, and can be designed according to actual needs.

[0170] The second developing member 70b is arranged on the first distal disc 111, and the third developing member 70c is arranged on the second proximal disc 114. The connecting wire 73 includes a waist portion 732 and a first extension portion 733 and a second extension portion 734 arranged at the two axial ends of the waist portion 732, wherein the waist portion 732 extends in an axial direction, one end of the first extension portion 733 is connected to the waist portion 732, the other end extends in a radial direction and is connected to the second developing member 70b, one end of the second extension portion 734 is connected to the waist portion 732, and the other end extends in a radial direction and is connected to the third developing member 70c. In this way, the shape of the connecting wire 73 matches the internal contour of the occlusion main body 10, and after the occlusion device 100 is implanted, the connecting wire 73 can well show the contour shape of the occlusion device 100 under the developing equipment. The waist portion 12 segment of the connecting wire 73 can show the inclined direction of the "tunnel" of the foramen ovale, and the first extension portion and the second extension portion of the connecting wire 73 can show the unfolding shape of the occlusion disc 11, especially when the occlusion disc 11 is an eccentric structure, which can well indicate the eccentric direction.

[0171] Each technical feature of the above-described embodiments can be combined with any other technical feature, and for the sake of brevity, not all possible combinations are described, but it is understood that the scope of the present disclosure encompasses all such possible combinations.

[0172] The above-described embodiments are merely illustrative of several embodiments of the present application, and the description is relatively specific and detailed, but should not be understood as limiting the scope of the present application. It should be noted that, for those skilled in the art, several modifications and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the appended claims.

Claims

1. An occlusion device comprising an occlusion body having a lumen and being deformable, a cap connected to a distal end of the occlusion body, and a plug connected to a proximal end of the occlusion body, characterized in that, The plug head comprises a locking hole penetrating the inner cavity, and the occluder further comprises a locking member connected to the head at the distal end, the locking member comprises a locking portion arranged at the proximal end of the locking member, and the locking hole comprises an accommodating hole and a limiting hole in sequence from the proximal end to the distal end in the axial direction; the occluder has a first locking state, when in the first locking state, the proximal end of the locking portion can be completely accommodated in the accommodating hole, the limiting hole limits the locking portion from being pulled out of the distal end of the locking hole, and the locking portion can move in the axial direction in the accommodating hole under the action of external force and can be deflected in the radial direction to abut against the hole wall of the accommodating hole.

2. The occluder of claim 1, wherein, The locking member further comprises a connecting portion, the distal end of the connecting portion is connected to the head, and the proximal end of the connecting portion is connected to the locking portion; when in the first locking state, the connecting portion can be deflected in the radial direction to a preset deflection angle under the action of external force to drive the locking portion to be deflected in the radial direction to abut against the hole wall of the accommodating hole, and the preset deflection angle is less than or equal to 7°.

3. The occluder of claim 1, wherein, The locking portion comprises a cylindrical body and an elastic sleeve fixedly sleeved outside the cylindrical body, a gap is formed between the elastic sleeve and the cylindrical body in the radial direction, so that the elastic sleeve can be elastically deformed in the radial direction relative to the cylindrical body; and / or, the inner diameter of the elastic sleeve gradually decreases from the proximal end to the distal end.

4. An occlusion device comprising an occlusion body having a lumen and being deformable, a cap connected to a distal end of the occlusion body, and a plug connected to a proximal end of the occlusion body, wherein, The plug head comprises a locking hole penetrating the inner cavity, and the occluder further comprises a locking member connected to the head at the distal end, and a locking sleeve sleeved outside the locking member, the locking member comprises a locking portion arranged at the proximal end of the locking member, and the proximal end of the locking sleeve is closer to the distal end of the occluder than the proximal end of the locking portion; the occluder has a first locking state and a second locking state, when in the first locking state, the locking portion is locked with the locking hole, and when in the second locking state, the locking sleeve is locked with the locking hole.

5. The occluder of claim 4, wherein, The locking sleeve and the locking member are fixedly connected; or, the locking sleeve and the locking member are movably connected, and the locking hole comprises an accommodating hole, when in the first locking state, the proximal end of the locking portion can be completely accommodated in the accommodating hole, and when in the second locking state, the locking portion can move in the axial direction relative to the accommodating hole and the locking sleeve under the action of external force.

6. The occluder of claim 4, wherein, The locking hole comprises an accommodating hole and a limiting hole in sequence from the proximal end to the distal end in the axial direction, when in the first locking state, the proximal end of the locking portion can be completely accommodated in the accommodating hole, the limiting hole limits the locking portion from being pulled out of the distal end of the locking hole, and the locking portion can move in the axial direction in the accommodating hole under the action of external force and can be deflected in the radial direction to abut against the hole wall of the accommodating hole.

7. The occluder according to any one of claims 1, 2, 3, 6, wherein, The minimum hole diameter of the limiting hole is smaller than the maximum radial dimension of the locking portion; and / or, the length of the accommodating hole is greater than or equal to the length of the locking portion, the maximum hole diameter of the accommodating hole is greater than the maximum radial dimension of the locking member, and the minimum hole diameter of the accommodating hole is greater than the minimum radial dimension of the locking member.

8. The occluder according to any one of claims 1 to 6, wherein, The locking member further comprises a connecting portion, a distal end of the connecting portion is connected with the head, and a proximal end of the connecting portion is connected with the locking portion; the locking portion and the connecting portion are made of the same polymer material, which is degradable or non-degradable; the locking portion and the connecting portion satisfy one or more of the following conditions: The density of the locking portion is less than the density of the connecting portion; The hardness of the locking portion is less than the hardness of the connecting portion; The elastic modulus of the locking portion is less than the elastic modulus of the connecting portion.

9. The occluder according to any one of claims 1, 2, 3, 6, wherein, The locking member further comprises a connecting portion, the locking portion comprises a guide segment connected with a proximal end of the connecting portion and a main body segment connected with a proximal end of the guide segment, the accommodation hole comprises a first hole and a second hole in sequence from a proximal end to a distal end, the second hole is communicated with the first hole and the limiting hole at two axial ends respectively, and the radial dimension of the guide segment and the second hole gradually increases in a direction from the distal end to the proximal end.

10. The occluder according to any one of claims 1, 2, 3, 6, wherein, The locking member further comprises a connecting portion, the connecting portion comprises a connecting rod connected with the locking portion, the radial dimension of the connecting rod is less than the hole diameter of the limiting hole, and the ratio of the length of the limiting hole to the length of the locking portion ranges from 1 / 3 to 1 / 2.

11. The occluder according to any one of claims 1, 2, 3, 6, wherein, The locking member further comprises a connecting portion, the connecting portion comprises a connecting rod connected with the locking portion, the locking portion comprises a guide segment connected with a proximal end of the connecting rod and a main body segment connected with a proximal end of the guide segment, the ratio of the radial dimension of the main body segment to the radial dimension of the connecting rod ranges from 1.03 to 1.23, the ratio of the length of the main body segment to the length of the guide segment ranges from 2 to 4; and / or, the ratio of the radial dimension of the main body segment to the hole diameter of the limiting hole ranges from 1.01 to 1.

14.

12. The occluder of claim 9, wherein, The main body segment is of an equal-diameter structure, or the radial dimension of the main body segment gradually increases in a direction from the distal end to the proximal end.

13. The occluder of claim 9, wherein, The ratio of the hole diameter of the first hole to the maximum radial dimension of the main body segment ranges from 1.015 to 1.

15.

14. The occluder of any one of claims 1 to 6, wherein, The locking member further comprises a connecting portion, the connecting portion comprises a connecting rod connected with the locking portion; the locking portion has a radial symmetry structure; or the locking portion has a radial asymmetry structure, the locking portion comprises opposite first and second sides in the radial direction, the first side protrudes radially outward relative to the connecting rod, the second side is located on the same circumferential surface as the connecting rod, or the second side protrudes radially outward relative to the connecting rod; the degree of radial protrusion of the first side relative to the connecting rod is greater than the degree of radial protrusion of the second side relative to the connecting rod.

15. The occluder of claim 14, wherein, The occlusion device comprises a developing point for indicating that the occlusion device is released in a predetermined manner to make the distal end of the connecting portion deviate from the direction in which the proximal end of the connecting portion protrudes toward the first side after the occlusion device is released.

16. The occluder according to any one of claims 1, 2, 3, 6, wherein, The locking hole further comprises a guide hole located at a distal end of the limiting hole, the guide hole is communicated with the limiting hole, and the hole diameter of the guide hole gradually increases in a direction from the proximal end to the distal end.

17. The occluder of claim 16, wherein, The plug head comprises an inner sleeve and an outer sleeve, the proximal end of the occlusion body is constricted and fixed between the inner sleeve and the outer sleeve, the locking hole is located in the inner sleeve, the distal end of the inner sleeve is flush with the distal end of the outer sleeve, or the distal end of the inner sleeve is closer to the distal end of the occluder than the distal end of the outer sleeve.

18. An occlusion system, characterized by The occluder comprises the occluder and a delivery device, the delivery device comprises a hollow push cable and a control cable arranged in the push cable, the control cable is axially movable relative to the push cable, and the distal end of the control cable can be extended from the distal end of the push cable, the proximal end of the locking member is detachably connected with the distal end of the control cable, and the plug head is detachably connected with the distal end of the push cable.

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