Plugging device and plugging system

Abstract

The plugging device comprises a plugging body, a sealing head connected with the far end of the plugging body and a bolt head connected with the near end of the plugging body, the bolt head comprises a locking hole communicated with an inner cavity, the plugging device further comprises a locking piece with the far end connected with the sealing head, and the locking piece comprises a locking part arranged at the near end of the locking piece. The locking hole sequentially comprises an axially-through containing hole and a limiting hole in the direction from the near end to the far end. The plugging device has a first locking state, when the plugging device is in the first locking state, the near end of the locking part can be completely contained in the containing hole, the limiting hole limits the locking part to be disengaged from the far end of the locking hole, and the locking part can move in the containing hole in the axial direction under the action of external force and can deflect in the radial direction to abut against the hole wall of the containing hole. The plugging device has the advantages of good locking effect, high locking efficiency, high fault-tolerant rate of surgical operation and better safety performance.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an occluder and occlusion system. Background Technology

[0002] Common types of congenital heart disease include atrial septal defect, ventricular septal defect, patent ductus arteriosus, and patent foramen ovale. With the continuous development of interventional medical devices and procedures, interventional therapy has become a more acceptable treatment method for many patients. Conventional minimally invasive interventional procedures use cardiac occluders for closure.

[0003] Currently, commercially available cardiac occluders generally consist of an occluder body with two occluder units to cover the tissue on both sides of the defect site, and nickel-titanium metal occluders are the most common. With technological advancements, occluders made of polymer materials have also begun to be used for implantation in recent years. However, polymer materials have low or no elasticity, which may result in the occluder not conforming to the expected shape after release from the delivery system, failing to fit snugly against the sides of the defect site and affecting the occlusion effect. Therefore, occluders require an effective constraint structure to maintain a stable distance between the two occluder units, ensuring good occlusion shape and reliable occlusion. Summary of the Invention

[0004] Based on this, the present invention proposes a plugging device and a plugging system with a locking function.

[0005] This invention provides a plugging device, comprising a plugging body having an inner cavity and being deformable, an end cap connected to the distal end of the plugging body, and a plug head connected to the proximal end of the plugging body. The plug head includes a locking hole communicating with the inner cavity. The plugging device further includes a locking member connected to the end cap at its distal end. The locking member includes a locking portion disposed at the proximal end of the locking member. The locking hole includes, from the proximal end to the distal end, an axially penetrating receiving hole and a limiting hole. The plugging device has a first locked state. When in the first locked state, the proximal end of the locking portion can be completely received in the receiving hole. The limiting hole restricts the locking portion from disengaging from the distal end of the locking hole. Furthermore, the locking portion can move axially in the receiving hole under the action of an external force and can be radially deflected to abut against the hole wall of the receiving hole.

[0006] In one embodiment, the locking member further includes a connecting portion, the distal end of which is connected to the end cap and the proximal end of which is 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, so as to drive the locking portion to be radially deflected to abut against the wall of the receiving hole, wherein the preset deflection angle is less than or equal to 7°.

[0007] In one embodiment, the locking part includes a cylindrical body and an elastic sleeve sleeved and fixed outside the cylindrical body, wherein a radial gap is formed between the elastic sleeve and the cylindrical body 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] This invention provides an occluder, comprising an occluder body having an inner cavity and being deformable, an end cap connected to the distal end of the occluder body, and a plug head connected to the proximal end of the occluder body. The plug head includes a locking hole communicating with the inner cavity. The occluder also includes a locking member connected to the end cap at its distal end, and a locking sleeve sleeved over the locking member. The locking member includes a locking portion located 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 engages with the locking hole. When in the second locking state, the locking sleeve engages with the locking hole.

[0009] In one embodiment, the locking sleeve is fixedly connected to the locking member; or, the locking sleeve is movably connected to the locking member, and the locking hole includes a receiving hole. When in the first locking state, the proximal end of the locking part can be completely received in the receiving hole. When in the second locking state, the locking part can move axially relative to the receiving hole and the locking sleeve under the action of external force.

[0010] In one embodiment, the locking hole includes an axially penetrating 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 part can be completely received in the receiving hole, and the limiting hole restricts the locking part from disengaging from the distal end of the locking hole. Furthermore, the locking part can move axially in the receiving hole under the action of external force and can be radially deflected to abut against the hole wall of the receiving hole.

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

[0012] In one embodiment, the locking member further includes a connecting portion, the distal end of which is connected to the end cap and the proximal end of which is connected to the locking portion; the locking portion and the connecting portion are made of the same polymer material, which may be degradable or non-degradable, and the locking portion and the connecting portion satisfy one or more of the following conditions: The density of the locking part is less than the density of the connecting part; The hardness of the locking part is less than the hardness of the connecting part; The elastic modulus of the locking part is less than that of the connecting part.

[0013] In one embodiment, the locking member further includes a connecting portion, the locking portion including a guide section connected to the proximal end of the connecting portion and a main body section connected to the proximal end of the guide section, the receiving hole including a first hole and a second hole in sequence from the proximal end to the distal end, the two ends of the second hole being connected to the first hole and the limiting hole respectively, and the radial dimensions of the guide section and the second hole gradually increase from the distal end to the proximal end.

[0014] In one embodiment, the locking member further includes a connecting portion, the connecting portion including a connecting rod connected to the locking portion, the radial dimension of the connecting rod being smaller than the diameter of the limiting hole, and the ratio of the length of the limiting hole to the length of the locking portion being in the range of 1 / 3 to 1 / 2.

[0015] In one embodiment, the locking member further includes a connecting portion, the connecting portion including a connecting rod connected to the locking portion, the locking portion including a guide section connected to the proximal end of the connecting rod and a main body section connected to the proximal end of the guide section, the ratio of the radial dimension of the main body section to the radial dimension of the connecting rod being in the range of 1.03 to 1.23, the ratio of the length of the main body section to the length of the guide section being in the range of 2 to 4; and / or, the ratio of the radial dimension of the main body section to the diameter of the limiting hole being in the range of 1.01 to 1.14.

[0016] In one embodiment, the main body segment is of constant diameter, or the radial dimension of the main body segment gradually increases from the distal end to the proximal end.

[0017] In one embodiment, the ratio of the diameter of the first hole to the maximum radial dimension of the main body segment is in the range of 1.015 to 1.15.

[0018] In one embodiment, the locking member further includes a connecting portion, the connecting portion including a connecting rod connected to the locking portion; the locking portion has a radially symmetrical structure; or, the locking portion has a radially asymmetrical structure, the locking portion including a first side and a second side opposite to each other in the radial direction, the first side protruding radially outward relative to the connecting rod, the second side being substantially located on the same circumferential surface as the connecting rod, or, the second side protruding radially outward relative to the connecting rod; the degree to which the first side protrudes radially relative to the connecting rod is greater than the degree to which the second side protrudes radially relative to the connecting rod.

[0019] In one embodiment, the occluder includes a development point for indicating that the occluder is released and shaped in a predetermined manner, such that after the occluder is released and shaped, the distal end of the connector is offset relative to the proximal end of the connector toward the first side protrusion.

[0020] In one embodiment, the locking hole further includes a guide hole located at the distal end of the limiting hole, the guide hole communicating with the limiting hole, and the diameter of the guide hole gradually increasing from the proximal end to the distal end.

[0021] In one embodiment, the plug head includes 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 inside 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.

[0022] The present invention provides a occlusion system, comprising an occluder and a conveyor as described in any of the preceding claims. The conveyor includes a hollow push cable and a control cable passing through the push cable. The control cable is axially movable relative to the push cable, and the distal end of the control cable can extend from the distal end of the push cable. The proximal end of the locking member is detachably connected to the distal end of the control cable, and the plug head is detachably connected to the distal end of the push cable.

[0023] The locking component of the occluder provided by this invention includes a connecting portion and a locking portion, with the locking portion located at the proximal end of the locking component. A locking hole located within the plug head extends through both axial ends of the plug head and sequentially includes an axially extending receiving hole and a limiting hole from the proximal end to the distal end. The occluder has a first locked state. In this first locked state, the proximal end of the locking portion can be completely received in the receiving hole, and the limiting hole restricts the locking portion from disengaging from the distal end of the locking hole. Furthermore, the locking portion can move axially within the receiving hole under external force and can be radially deflected to abut against the wall of the receiving hole. The occluder of this invention has excellent locking effect, high locking efficiency, high surgical operation error tolerance, and superior safety performance. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the blocker in one embodiment of this application; Figure 2 This is a schematic diagram showing the cooperation between the plug head and locking element of the plug and the conveyor in one embodiment of this application; Figure 3 This is a schematic diagram showing the engagement between the locking element and the plug head when the plug is in the first locked state in one embodiment of this application; Figure 4 This is a schematic diagram of the plug head of the plugging device in one embodiment of this application; Figure 5 This is a partial structural schematic diagram of the locking element of the plugging device in one embodiment of this application; Figure 6 This is a partial structural schematic diagram of the locking element of the plugger in another embodiment of this application; Figure 7 This is a schematic diagram showing the locking element and the plug head of the plug in a "self-locking" state in one embodiment of this application; Figure 8 This is a schematic diagram of the occluder implanted in one embodiment of this application; Figure 9 This is a schematic diagram of the plug head of the plugging device in one embodiment of this application; Figure 10 This is a partial structural schematic diagram of the locking element of the plugger in another embodiment of this application; Figure 11 This is a partial perspective view of the locking element of the plugger in another embodiment of this application; Figure 12 for Figure 11 A schematic diagram showing the fit between the locking element and the bolt head; Figure 13 for Figure 11 Top view of the locking component; Figure 14 for Figure 11 A schematic diagram showing the proximal end of the locking element extending from the bolt head; Figure 15 for Figure 11 A schematic diagram showing the locking element and the bolt head in a "self-locking" state; Figure 16 This is a schematic diagram of the occluder implanted in another embodiment of this application; Figure 17 This is a schematic diagram showing the engagement of the locking element and the plug head in a first locked state according to one embodiment of this application. Figure 18 This is a schematic diagram showing the engagement of the locking element and the plug head in a second locked state according to one embodiment of this application. Figures 19(a) to 19(d) are schematic diagrams of the locking process of the plug in another embodiment of this application; Figure 20 This is a schematic diagram of the end cap and structure of the plugging device in one embodiment of this application; Figure 21 This is a schematic diagram showing the connection between the end cap and the locking member in one embodiment of this application; Figure 22 This is a schematic diagram showing the stabilizing semi-finished product located in the connecting cavity in one embodiment of this application; Figure 23 This is a schematic diagram of the structure of the stabilizing part in one embodiment of this application; Figure 24 This is a schematic diagram of the stabilizing unit and the attached pipe semi-finished product located in the connecting cavity in one embodiment of this application; Figure 25 This is a schematic diagram of a developing ring disposed on a stabilizing part in one embodiment of this application; Figure 26 This is a schematic diagram showing the movable connection between the locking part and the end cap in another embodiment of this application; Figure 27 for Figure 26 A schematic diagram showing the movement of the locking part relative to the end cap towards the distal end; Figure 28 This is a schematic diagram of the locking part and the end cap in another embodiment of this application; Figure 29 for Figure 28 A schematic diagram showing the radial movement of the connecting rod relative to the limiting cavity; Figure 30 This is a schematic diagram of a locking part with an inner hole in one embodiment of this application; Figure 31 This is a schematic diagram of a locking part with an inner hole in another embodiment of this application; Figure 32 for Figure 31 A schematic diagram of the bending deformation of the connecting rod in the middle; Figure 33 This is a half-sectional schematic diagram of the plugging device in one embodiment of this application (the mesh structure of the plugging body is not shown). Figure 34 This is a partial structural schematic diagram of the sealing body in one embodiment of this application; Figure 35 This is a schematic diagram of the structure of the developing element in one embodiment of this application; Figure 36 This is a schematic diagram of the winding of the developing wire in one embodiment of this application; Figure 37 This is a schematic diagram of the winding of polymer winding thread in one embodiment of this application; Figure 38 This is a schematic diagram of the winding of the developing filament in another embodiment of this application; Figure 39This is a schematic diagram of the structure of the plugging device in one embodiment of this application (the mesh structure of the plugging body is not shown). Figure 40 This is a schematic diagram of the blocker in another embodiment of this application (the grid structure of the blocker body is not shown). Detailed Implementation

[0025] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0026] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0027] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0028] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0029] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0030] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0031] It should be noted that in this application, "proximal end" refers to the end of the occluder that is closer to the operator during the implantation procedure, and "distal end" refers to the end that is farther away from the operator; "axial" refers to the length direction of the occluder when it is being delivered, and "radial" refers to the direction of the occluder that is perpendicular to its "axial" direction.

[0032] The occluder 100 of this invention is suitable for the treatment of congenital heart diseases such as atrial septal defect, ventricular septal defect, patent ductus arteriosus, and patent foramen ovale. The common method is to place the occluder 100 at the defect site to close it. For ease of understanding, the following embodiments use patent foramen ovale as an example application scenario. In other embodiments, the occluder 100 of this invention can be applied to any other suitable application scenario.

[0033] See Figure 1 The plugging device 100 includes a plugging body 10, an end cap 20, a plug head 30, and a locking element 40. The plugging body 10 has an internal cavity and can deform under external force, so that the plugging device 100 can be radially compressed into a delivery device and can be released from the delivery device and deformed into an expanded shape. The distal end of the plugging body 10 is connected to the end cap 20 (e.g., fixed connection), and the proximal end of the plugging body 10 is connected to the plug head 30 (e.g., fixed connection).

[0034] For example, in its natural expansion state without external human force, the sealing body 10 includes a waist portion 12 and two disc portions 11, which are connected one-to-one to the two ends of the waist portion 12 along the axial direction. 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 dimensions of both the proximal disc portion 11a and the distal disc portion 11b are larger than the radial dimension (or radial width) of the waist portion 12. The waist portion 12 can be tubular or bundled, or any suitable shape. The distal disc portion 11b and the proximal disc portion 11a are both disc-shaped. The cross-sectional shape of the waist portion 12, the distal disc portion 11b, and the proximal disc portion 11a can be circular, elliptical, polygonal, or any suitable shape. The diameter of the distal disc portion 11b and the proximal disc portion 11a is larger than the diameter of the defect or channel to be sealed. Taking the treatment of patent foramen ovale (PFO) as an example, before implanting the occluder 100, the occluder body 10 is first stretched axially (i.e., radially compressed) to retract into the sheath. The occluder 100 is then delivered to the PFO through the sheath. The occluder 100 is then released from the sheath, causing the occluder body 10 to radially expand or inflate. The waist portion 12 of the occluder body 10 passes through the PFO passage, while the distal disc portion 11b and proximal disc portion 11a are located on either side of the atrial septum and abut against the sidewalls of the atrial septum, thereby sealing the PFO passage. It should be noted that due to differences in the location of the defect or passage to be sealed, the morphology may vary. Therefore, the expansion morphology (or working state) of the occluder 100 after implantation may differ from the actual condition. Figure 1 The shape of the plug 100 varies in its natural expansion state, but regardless of the expansion state, the radial dimension of the disc portion 11 of the plug 100 is larger than its radial dimension in the radial compression state.

[0035] In other embodiments, the number of discs 11 may be one or more. For example, the proximal disc 11a described above may be omitted, and the plug head 30 is connected to the proximal end of the waist 12 to tighten the proximal end of the waist 12 and close the proximal end of the occlusion body 10. Alternatively, the occluder 100 may have three or more, and the number of waists 12 may also be increased to ensure that two adjacent discs 11 are connected through the waist 12.

[0036] The aforementioned sealing body 10 can be woven from multiple braided filaments and / or braided strands to form a sealing mesh tube with multiple openings. In other embodiments, the sealing body 10 can be woven from braided filaments and / or braided strands to form any other suitable shape, or the sealing body 10 can be cut to form a suitable shape.

[0037] The aforementioned braided filaments and braided strands can be made of metal or polymer materials. For example, the sealing body 10 can be formed into a three-dimensional mesh structure with openings by weaving multiple braided filaments and multiple braided strands together. The braided filaments are monofilaments, each with a diameter ranging from 0.1 to 0.5 mm. Each braided strand comprises multiple polymer fiber threads, which are combined into a single strand. This strand can be one or more of two-ply, three-ply, or multi-ply strands. The specifications of each braided strand range from 50D / 18F to 600D / 144F to balance mechanical properties and flexibility requirements. 50D / 18F means that each braided strand contains 18 polymer fiber threads, and the total mass of these 18 polymer fiber threads is 50 Tennessee (D). 600D / 144F has the same meaning and will not be elaborated further here. In other embodiments, the specifications of each braided strand range from 30D / 72F to 100D / 72F or 50D / 72F to 100D / 72F, with a twist of 1 to 30 twists / 10cm. This balances mechanical performance and flexibility, resulting in less clamping and compression of the tissue by the occluder 100, while minimizing tissue abrasion, but preventing it from detaching from the defect site. The sum of the number of braided filaments and braided strands ranges from 36 to 72, and the ratio of the number of braided filaments to the number of braided strands ranges from 2:1 to 1:2. This balances mechanical performance and flexibility while maintaining a small radial dimension of the occluder 100 after stretching, thus allowing for delivery using a smaller diameter delivery sheath. The materials used for the braided filaments and braided strands are biocompatible. For example, in this embodiment, polylactic acid is selected to make braided filaments and braided strands. In other embodiments, the materials for braided filaments and braided strands can be other biodegradable polymers such as polydioxanone, polycaprolactone, polyurethane, polydioxanone, or polyamide, or non-biodegradable polymers such as polyethylene terephthalate, or metals such as stainless steel or nickel-titanium.

[0038] The proximal ends of the braided filaments and / or braided strands are gathered and fixed into the plug head 30 to close the proximal end of the plugging body 10, and the distal ends of the braided filaments and / or braided strands are gathered and fixed into the plug head 20 to close the distal end of the plugging body 10.

[0039] For example, the end cap 20 is generally cylindrical and may include a receiving interlayer with an opening at one end, the opening of which faces the distal or proximal end of the end cap 20. The distal ends of the braided filaments and / or braided strands can extend into the receiving interlayer through the opening and be fixedly connected to the end cap 20 by welding, heat fusion, adhesive bonding, or other methods. The plug head 30 is also generally cylindrical and similarly has a receiving interlayer, the opening of which faces the distal or proximal end of the plug head 30. The proximal ends of the braided filaments and / or braided strands can extend into the receiving interlayer of the plug head 30 through the opening and be fixedly connected to the plug head 30 by welding, heat fusion, adhesive bonding, or other methods. In other embodiments, the end cap 20 and the plug head 30 may be any other suitable structure and shape, and the connection method between the end cap 20 and the plug head 30 and the plug body 10 may also differ from the example described above.

[0040] It is understood that the structure of the sealing body 10 is only used as an example and is not intended to limit the present invention. Those skilled in the art can choose any suitable structure of the sealing body 10 under the guidance of the present invention. When the sealing body 10 is made of polymer material, the low or no elasticity of the polymer material may result in the sealing device 100 not achieving the expected molding effect after being released from the conveyor, and failing to adhere tightly to both sides of the defect, thus affecting the sealing effect. Therefore, the sealing device 100 provided by this invention also includes a locking member 40, the distal end of which is connected to the sealing head 20. For example, the distal end of the locking member 40 can be fixedly connected to the sealing head 20 by welding, hot melting, adhesive bonding, etc. The locking member 40 is at least partially or completely inserted into the inner cavity of the sealing body 10. The plug head 30 includes a locking hole 31 that communicates with the inner cavity of the sealing body 10. The proximal end of the locking member 40 can be inserted into the locking hole 31 and form a locking engagement with the locking hole 31, so that the locking member 40 and the plug head 30 are locked together. Under the absence of external force, the locking member 40 and the plug head 30 remain connected, so that the plugger 100 can be well formed and maintain a relatively stable expansion state, which is conducive to maintaining the good sealing effect of the plugger 100.

[0041] Reference Figure 1 , Figure 2The delivery device that cooperates with the plugging device 100 may include a hollow push cable 50 and a control cable 60 passing through the inner cavity of the push cable 50. The control cable 60 is axially movable relative to the push cable 50, and the distal end of the control cable 60 can extend from the distal opening of the push cable 50. The proximal end of the locking member 40 can be detachably connected to the distal end of the control cable 60, and the plug head 30 can be detachably connected to the distal end of the push cable 50. The detachable connection is not limited to any suitable method such as threaded connection or snap-fit. For example, the proximal end of the locking member 40 may include a first thread (e.g., internal thread), and the distal end of the control cable 60 may include a second thread (e.g., external thread), and the two are detachably connected by threaded engagement. The plug head 30 includes a third thread (e.g., external thread), and the distal end of the push cable 50 may include a fourth thread (e.g., internal thread), and the two are detachably connected by threaded engagement. It is understood that the detachable connection between the delivery device and the locking member 40 and the plug head 30 can be achieved by any other suitable method.

[0042] When the occluder 100 is connected to the delivery device, and when radial compression of the occluder 100 is required (e.g., when it needs to be constricted into the delivery device's conduit), the locking member 40 and the plug head 30 can be released, and the push control cable 60 can be moved toward the distal end relative to the push cable 50, thereby causing the locking member 40 to move toward the distal end relative to the plug head 30. This causes the plug head 20 and the plug head 30 of the occluder 100 to move away from each other, and the occlusion body 10 is axially elongated to form an elongated tubular structure, thus achieving radial compression. When radial expansion of the occluder 100 is required (e.g., when the occluder 100 needs to expand to the working state), the control cable 60 can be pulled relative to the push cable 50 to move towards the proximal end, thereby causing the locking member 40 to move relative to the plug head 30 towards the proximal end, so that the end cap 20 and the plug head 30 of the occluder 100 move closer to each other, and the occlusion body 10 is axially compressed to achieve radial expansion. When the end cap 20 and the plug head 30 of the occluder 100 are locked together, the expansion state of the occlusion body 10 can be maintained better.

[0043] The following examples illustrate the technical solutions of the locking member 40 and its related mating elements.

[0044] First Embodiment See Figures 3 to 5In this embodiment, the locking member 40 includes a connecting portion 41 and a locking portion 42, with the locking portion 42 located at the proximal end of the locking member 40. A locking hole 31 located within the plug head 30 extends through both axial ends of the plug head 30, and sequentially includes an axially extending receiving hole 311 and a limiting hole 312 from the proximal end to the distal end. The plug 100 has a first locked state. When in the first locked state, the proximal end of the locking portion 42 can be completely received in the receiving hole 311, and the limiting hole 312 restricts the locking portion 42 from disengaging from the distal end of the locking hole 31. Furthermore, the locking portion 42 can move axially within the receiving hole 311 under external force and can be radially deflected to abut against the wall of the receiving hole 311. In the first locked state, the limiting hole 312 restricts the locking part 42 from disengaging from the distal end of the locking hole 31. Since the limiting hole 312 is only a part of the locking hole 31 and located at the distal end of the receiving hole 311, the locking stroke of the occluder 100 is short, resulting in high locking efficiency. This effectively maintains the mutual locking between the locking members 40 of the thrombus head 30, thereby better maintaining the expansion state of the occluder 100 and achieving a better occlusion effect. After locking, the proximal end of the locking part 42 can be completely accommodated in the receiving hole 311, reducing the possibility of the locking member 40 extending beyond the proximal end of the thrombus head 30, forming a thrombus, or disrupting blood flow, thus improving the safety of the occluder 100. Furthermore, since the locking part 42 can move axially within the receiving hole 311 under external force in the first locked state, on the one hand, even if the locking part 42 is pulled to the proximal end of the protruding head 30 by the control cable 60 during the operation, after implantation, with the heartbeat, the locking part 42 can still move axially relative to the receiving hole 311, thereby automatically retracting into the receiving hole 311. Therefore, the error tolerance of the surgical operation is improved. On the other hand, the locking member 40 can form displacement compensation with the heartbeat, improving the overall service life of the locking member 40 and further improving the safety of the occluder 100. (Refer to...) Figure 7 , Figure 8 Furthermore, in the first locked state, the locking part 42 can be radially deflected under the action of external force to abut against the wall of the receiving hole 311. When a tilted defect or channel is to be sealed (for example, an oval hole usually has a tilted "tunnel"), after the plugger 100 is inserted, the locking member 40 will tilt accordingly, thereby causing the locking part 42 to tilt radially and abut against the wall of the receiving hole 311. This makes it more difficult for the locking part 42 to move further to the distal end relative to the receiving hole 311, and the two achieve "self-locking". This further reduces the possibility of the locking part 42 coming off the distal end of the plug head 30 and improves the firmness of the lock between the locking member 40 and the plug head 30.

[0045] There are several ways in which the limiting hole 312 restricts the locking part 42 from disengaging from the distal end of the locking hole 31. For example, in this embodiment, the minimum diameter of the limiting hole 312 is smaller than the maximum radial dimension (or maximum radial width) of the locking part 42. The locking part 42 and / or the locking hole 31 have a certain deformation capability. The locking part 42 can be pulled through the distal end of the locking hole 31 into the limiting hole 312 via the control cable 60. When the locking part 42 passes through the minimum diameter of the limiting hole 312 at the maximum radial dimension, the locking part 42 and / or the locking hole 31 undergo a certain elastic deformation, thereby allowing the locking hole 31 to be pulled through the limiting hole 312 into the receiving hole 311. After entering the receiving hole 311 and forming a lock, since the minimum diameter of the limiting hole 312 is smaller than the maximum radial dimension of the locking part 42, the limiting hole 312 can achieve the limiting effect on the locking part 42. The force of a simple heartbeat is insufficient to disengage the locking part 42 from the distal end of the plug head 30. For example, the ratio of the maximum radial dimension of the locking part 42 to the minimum diameter of the limiting hole 312 ranges from 1.01 to 1.14. For instance, this ratio can be any one of 1.01, 1.02, 1.03, 1.05, 1.07, 1.09, 1.0, 1.1, 1.12, or 1.14. This setting ensures that the axial force required for the locking part 42 to pass through the limiting hole 312 is moderate, avoiding locking difficulties, and providing a relatively secure locking effect between the locking member 40 and the bolt head 30 in the first locked state. In other embodiments, the dimensions of the locking part 42 and the limiting hole 312 can be set according to actual needs. Understandably, the way in which the limiting hole 312 restricts the locking part 42 from disengaging from the distal end of the locking hole 31 is not limited to this. For example, the locking part 42 may have a cylindrical structure extending along the axial direction, and the limiting hole 312 may be inclined relative to the axial direction. After the locking part 42 enters the receiving hole 311 through the limiting hole 312, the limiting hole 312 can also play the role of restricting the locking part 42 from moving to the distal end.

[0046] The length of the aforementioned receiving hole 311 can be greater than or equal to the length of the locking part 42. For example, the length of the receiving hole 311 can be 0.5 mm to 1 mm longer than the length of the locking part 42. This arrangement allows the receiving hole 311 to completely accommodate the locking part 42, reducing the risk of slow endothelialization or myocardial tissue injury caused by the locking member 40 extending too far. Furthermore, the maximum diameter of the receiving hole 311 can be greater than the maximum radial dimension of the locking member 40, and the minimum diameter of the receiving hole 311 can be greater than the minimum radial dimension of the locking member 40. This arrangement allows the locking part 42 to move more smoothly within the receiving hole 311 in the first locked state.

[0047] In this embodiment, the distal end of the connecting part 41 is connected to the end cap 20, and the proximal end of the connecting part 41 is connected to the locking part 42. For example, the connecting part 41 includes a connecting rod 411, the distal end of which can be fixedly connected to the end cap 20 by welding, hot melting, or adhesive bonding. The connecting rod 411 and the locking part 42 are integrally formed, or fixedly connected by welding, hot melting, or adhesive bonding. Since the sealing body 10 itself can deform, when in the first locked state, the connecting part 41 can be radially deflected to a preset deflection angle under the action of external force, so as to drive the locking part 42 to be radially deflected to abut against the wall of the receiving hole 311. The preset deflection angle can be set by designing the structure and size of the locking member 40 and the locking hole 31. The preset deflection angle can be set according to the actual application scenario. For example, the "tunnel" of the foramen ovale usually has a relatively fixed tilt direction, and its tilt angle is usually greater than or equal to 7°. Therefore, in the application scenario of sealing the patent foramen ovale, the preset deflection angle can be set to less than or equal to 7°. This setting allows the locking part 42 to abut against the wall of the receiving hole 311 more likely to form a "self-locking" after the occluder 100 is implanted. Understandably, in other application scenarios, the preset tilt angle can be set according to actual needs.

[0048] The aforementioned locking part 42 includes a guide section 421 connected to the proximal end of the connecting part 41 and a main body section 422 connected to the proximal end of the guide section 421. Correspondingly, the receiving hole 311 includes a first hole 3111 and a second hole 3112 sequentially from the proximal end to the distal end. The two ends of the second hole 3112 are respectively connected to the first hole 3111 and the limiting hole 312. Along the distal end to the proximal end, the radial dimensions of both the guide section 421 and the second hole 3112 gradually increase. By setting the mutually cooperating guide section 421 and the second hole 3112, the locking part 42 can be guided into the limiting hole 312, allowing the locking part 42 to be unlocked relatively smoothly under the action of external force. This improves the error tolerance of the surgical operation. If the effect of locking after the occluder 100 is not ideal, it can be released by unlocking the occluder 100 and repositioning it. In addition, the contour shape of the second hole 3112 and the contour shape of the outer wall of the guide section 421 are adapted to each other. Both have convex arc surfaces and similar curvatures. When the locking part 42 is inserted and tilted radially, the guide section 421 and the hole wall of the second hole 3112 abut against each other, which can also play a certain limiting role and further enhance the locking effect between the locking part 40 and the locking hole 31. For example, 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 instance, the ratio can be any one of 1.03, 10.5, 1.08, 1.09, 1.0, 1.1, 1.15, 1.2, or 1.23. 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. This arrangement allows the guide segment 421 to both provide good guidance and good limiting effect when the locking part 42 is tilted. In other embodiments, the second hole 3112 may be omitted.

[0049] The aforementioned main body segment 422 can be a constant diameter structure (refer to...). Figure 5 ( ) or non-uniform diameter structures. For example, refer to Figure 6When the main body segment 422 has a non-uniform diameter structure, its radial dimension gradually increases from the distal end to the proximal end, and its taper can be controlled between 2.5% and 4%. The taper of the main body segment 422 is the percentage of the length of the main body segment 422 relative to the difference between its distal and proximal radial dimensions. In other embodiments, the taper of the main body segment 422 can be any other arbitrary value. The uniform diameter structure and the structure with a gradually increasing radial dimension from the distal end to the proximal end facilitate guiding the locking part 42 extending from the proximal end of the locking hole 31 back into the receiving hole 311. In other embodiments, the main body segment 422 can have any other suitable shape and structure. The first hole 3111 can be a uniform diameter hole or a non-uniform diameter hole. For example, when the first hole 3111 is a non-uniform diameter hole, its diameter gradually increases from the distal end to the proximal end. Compared to non-equal diameter holes, when the first hole 3111 is an equal diameter hole, it is easier to form a "self-locking" connection with the locking part 42. For example, the ratio of the diameter of the first hole 3111 to the maximum radial dimension of the main body segment 422 ranges from 1.015 to 1.15. For instance, this ratio can be any one of 1.015, 1.02, 1.03, 1.04, 1.05, 1.06, 1.08, 1.1, 1.12, or 1.15. This arrangement allows the main body segment 422 to move more smoothly axially or radially within the first hole 3111, and makes it easier for the locking part 42 to form a "self-locking" connection with the receiving hole 311.

[0050] In this embodiment, the radial dimension of the connecting rod 411 is smaller than the diameter of the limiting hole 312, and the length of the limiting hole 312 is smaller than the length of the locking part 42. For example, the ratio of the length of the limiting hole 312 to the length of the locking part 42 is between 1 / 3 and 1 / 2. If the length of the limiting hole 312 is too long, it will be difficult for the connecting rod 411 to tilt in the limiting hole 312, or the tilt angle will be small or even remain coaxial with the limiting hole 312. As a result, it will be difficult for the locking part 42 to tilt radially relative to the receiving hole 311 or the tilt angle will be small. It will be difficult for the locking part 42 to abut against the inner wall of the receiving hole 311 to form a "self-locking". If the limiting hole 312 is too short, it will be difficult to play a good limiting role. The locking part 42 will be more likely to come out from the distal end of the plug head 30, thereby causing the unlocking failure of the plug 100. By reasonably setting the ratio of the length of the limiting hole 312 to the length of the locking part 42 to be between 1 / 3 and 1 / 2, the locking part 42 can easily form a "self-locking" with the receiving hole 311, and the limiting hole 312 has a good limiting effect, thereby improving the firmness of the locking member 40 and the bolt head 30.

[0051] Optionally, the limiting hole 312 may have a uniform or non-uniform diameter. The ratio of the diameter of the limiting hole 312 to the radial dimension of the connecting rod 411 may be in the range of 1.05 to 1.09, so that the connecting rod 411 can tilt at a suitable angle in the limiting hole 312, thereby enabling the locking part 42 to form a "self-locking" with the receiving hole 311 while avoiding the overall radial dimension of the bolt head 30 being too large.

[0052] The ratio of the radial dimension of the main body segment 422 to the diameter of the limiting hole 312 ranges from 1.01 to 1.14. For example, this ratio can be any one of 1.01, 1.02, 1.03, 1.05, 1.07, 1.09, 1.0, 1.1, 1.12, or 1.14. This arrangement ensures a high degree of locking strength between the locking member 40 and the bolt head 30, and that the axial force required for the main body segment 422 to pass through the limiting hole 312 is appropriate, avoiding the need for excessive pulling or pushing forces during locking or unlocking.

[0053] The locking component 40 can be manufactured by methods such as heat setting, machining, and injection molding. The locking part 42 and the connecting part 41 are made of the same polymer material; for example, non-degradable polymer materials such as nylon and PE can be used, as well as degradable polymer materials such as PLLA and PDO. The locking part 42 and the connecting part 41 satisfy one or more of the following conditions: The density of the locking part 42 is less than the density of the connecting part 41. For example, the ratio of the density of the locking part 42 to the density of the connecting part 41 is in the range of 0.8 to 0.85. The hardness of the locking part 42 is less than that of the connecting part 41. For example, the ratio of the hardness of the locking part 42 to the hardness of the connecting part 41 is in the range of 0.8 to 0.85. The elastic modulus of the locking part 42 is less than that of the connecting part 41. For example, the ratio of the elastic modulus of the locking part 42 to that of the connecting part 41 is in the range of 0.8 to 0.85.

[0054] Since the locking part 42 and the connecting part 41 meet the above conditions, the locking part 42 has better elasticity or deformation capability, which makes the locking and unlocking process smoother. In addition, since the locking part 42 will form a self-locking with the receiving hole 311 after implantation, the locking part 42 that meets the above conditions can have better fatigue resistance.

[0055] In this embodiment, the locking hole 31 may further include a guide hole 313 located at the distal end of the limiting hole 312. The guide hole 313 communicates with the limiting hole 312, and its diameter 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. The maximum diameter of the guide hole 313 is greater than the maximum radial dimension of the locking part 42 to provide better guidance. In other embodiments, the guide hole 313 may be omitted.

[0056] Reference 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 inside the inner sleeve 32. 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 occluder 100 than the distal end of the outer sleeve 33. The protruding inner sleeve 32 not only provides better guidance but also provides some protection to the proximal end of the occlusion body 10. This reduces the probability of damage to the occlusion body 10 due to friction between the locking member 40 and the braided wires at the proximal end of the occlusion body 10 during locking and unlocking processes and subsequent implantation. In other embodiments, the plug head 30 may have only one sleeve or two or more sleeves.

[0057] The aforementioned locking part 42 can be an integral cylindrical structure (see reference). Figure 5 , Figure 6 (This can also be any other suitable structure. For example, refer 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 auxiliary tube 425. A radial gap is formed between the elastic sleeve 424 and the cylindrical body 423 so that the elastic sleeve 424 can elastically deform relative to the cylindrical body 423 in the radial direction. The cylindrical body 423 may be of equal diameter or unequal diameter. The proximal end of the auxiliary tube 425 is fixedly connected to the elastic sleeve 424. The auxiliary tube 425 is sleeved outside the cylindrical body 423, and the auxiliary tube 425 and / or the elastic sleeve 424 are fixedly connected to the cylindrical body 423. The elastic sleeve 424 can be a closed structure or a non-closed structure in the circumferential direction (for example, it can be composed of sheet-like structures spaced apart circumferentially, with multiple sheet-like structures enclosing the elastic sleeve 424). From the proximal end to the distal end, the inner diameter of the elastic sleeve 424 gradually decreases, giving it an approximately trumpet-like shape. Because the elastic sleeve 424 has superior elasticity, after the occluder 100 is implanted, with the heartbeat, the elastic sleeve 424 can offset some of the stress on the locking part 42 through its own elastic deformation, thereby improving the fatigue resistance and service life of the occluder 100. In other embodiments, the aforementioned connecting pipe 425 may be omitted.

[0058] The locking part 42 described above has a radially symmetrical structure. For example, Figures 1 to 10 The locking parts 42 in each part have a radially symmetrical structure.

[0059] In other embodiments, the locking part 42 may have a radially asymmetric structure. (See also...) Figures 11 to 15The locking part 42 includes a first side 426 and a second side 427 radially opposite each other. The first side 426 protrudes radially outward relative to the connecting rod 411, and the second side 427 is substantially located on the same circumferential surface as the connecting rod 411. The degree to which the first side 426 protrudes radially relative to the connecting rod 411 is greater than the degree to which the second side 427 protrudes radially relative to the connecting rod 411. The second side 427 and the connecting rod 411 being substantially located on the same circumferential surface means that the ratio between the distance from a point on the outer wall of the second side 427 to the extension of the central axis of the connecting rod 411 and 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 to 1.1. The degree to which the first side 426 protrudes radially relative to the connecting rod 411 is greater than the degree to which the second side 427 protrudes radially relative to the connecting rod 411 means that the distance from a point on the outer wall of the first side 426 to the extension 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 of the central axis of the connecting rod 411. For example, the ratio between the distance from the point on the outer wall of the first side 426 to the extension of the central axis of the connecting rod 411 and the distance from the 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 to 2. The single-sided protruding locking part 42 not only has good locking and unlocking effects, but also can still realize the "self-locking" function (see reference). Figure 15 Especially after implantation, when the distal end of the connecting portion 41 shifts towards the direction of the proximal end of the connecting portion 41 protruding towards the first side 426, if the locking portion 42 extends out of the proximal opening of the receiving hole 311, the second side 427 can play a good guiding role, guiding the locking portion 42 to retract into the receiving hole 311 with the heartbeat, while the first side 426, which protrudes more, can abut well against the hole wall of the receiving hole 311 to form a "self-locking" mechanism (see reference). Figure 15 ).

[0060] Reference Figure 16Because the "tunnel" of the foramen ovale is inclined in a specific direction, the distal end of the connecting portion 41 can be offset relative to the proximal end of the connecting portion 41 towards the first side 426 after the occluder 100 is implanted in a specific manner. For example, a developing element 70 can be provided on the occluder 100. The developing element 70 is used to instruct the occluder 100 to release and form in a predetermined manner, so that after the occluder 100 is released and formed, the connecting portion 41 is inclined in a preset direction, and the distal end of the connecting portion 41 is offset relative to the proximal end of the connecting portion 41 towards the first side 426. For example, a single developing element 70 can be provided on the waist portion 12 of the occluder 100. This developing element 70 can be located on the same side as the first side 426 or on the opposite side in the radial direction. The control cable 60 is made of a metal material (e.g., nickel-titanium alloy, stainless steel, etc.) and can be developed under a developing device. For example, the imaging element 70 is located on the same side as the first side 426 in the radial direction. During implantation, the tilt direction of the control cable 60 entering the tilted "tunnel" of the foramen ovale can be determined by observing the tilt direction of the control cable 60, which is also the tilt direction of the connector 41 after implantation. The circumferential position of the occluder 100 is adjusted so that the imaging element 70 is located on one side of the control cable 60, and this side is the side where the distal end of the connector 41 is offset from the proximal end of the connector 41 in the same direction (i.e., Figure 16 (the upper side of the middle), so that after implantation, the distal end of the connector 41 is offset relative to the proximal end of the connector 41 in the direction of protrusion toward the first side 426.

[0061] In other embodiments, the developing element 70 can be any suitable shape, such as circular, teardrop-shaped, number-shaped, or triangular. For example, the developing element 70 can be set as a teardrop-shaped, arrow-shaped, or triangular shape that can indicate direction, and the direction indicated by the developing element 70 can be the same as or opposite to the direction of the protrusion on the first side 426. By setting a shape that can indicate direction, the developing element 70 can more intuitively and accurately indicate the direction of the protrusion on the first side 426. In other embodiments, the developing element 70 can be any other suitable shape. In other embodiments, the developing element 70 can be omitted.

[0062] In another embodiment, both the first side 426 and the second side 427 protrude radially outward relative to the connecting rod 411, with the first side 426 protruding radially relative to the connecting rod 411 to a greater extent than the second side 427 protruding radially relative to the connecting rod 411.

[0063] Reference Figures 11 to 13The second side 427 occupies 1 / 3 to 3 / 4 of the circumferential area of ​​the locking portion 42. That is, in a cross-section passing through both the first side 426 and the second side 427, the angle α between the lines connecting the two circumferential ends of the second side 427 and the extension of the central axis of the connecting rod 411 is 120° to 270°. The first side 426 and the second side 427 complement each other to form the circumferential surface of the locking portion 42. This arrangement allows the first side 426 to form a good "self-locking" mechanism with the receiving hole 311, and the second side 427 to provide good guidance. In other embodiments, the proportions of the first side 426 and the second side 427 in the circumferential area of ​​the locking portion 42 can be set as needed.

[0064] The aforementioned receiving hole 311 can be a radially symmetrical structure (see reference). Figure 12 It can also be a radially asymmetrical structure, where the shape of the receiving hole 311 is adapted to the shape of the locking part 42, for example, referring to Figure 14 , Figure 15 When the receiving hole 311 has an asymmetrical structure, the receiving hole 311 includes a first hole wall 3113 and a second hole wall 3114. The first hole wall 3113 protrudes radially outward relative to the hole wall of the limiting hole 312. The second hole wall 3114 and the hole wall of the limiting hole 312 are substantially located on the same circumferential surface. The degree to which the first hole wall 3113 protrudes radially relative to the hole wall of the limiting hole 312 is greater than the degree to which the second hole wall 3114 protrudes radially relative to the hole wall of the limiting hole 312. Alternatively, both the first hole wall 3113 and the second hole wall 3114 protrude radially outward relative to the hole wall of the limiting hole 312, with the degree to which the first hole wall 3113 protrudes radially relative to the hole wall of the limiting hole 312 is greater than the degree to which the second hole wall 3114 protrudes radially relative to the hole wall of the limiting hole 312.

[0065] Second Embodiment Reference Figure 17 , Figure 18 In this embodiment, based on 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 part 42. The occluder 100 has a first locking state and a second locking state. When in the first locking state, the locking part 42 is locked into the locking hole 31. When in the second locking state, the proximal end of the locking sleeve 80 is locked into the locking hole 31.

[0066] By setting the locking sleeve 80, the occluder 100 has a first locking state and a second locking state. The distance between the sealing head 20 and the plug head 30 is different in the two locking states, allowing the occluder 100 to be locked in different states during surgery, depending on the length of the defect or channel to be sealed. Therefore, the occluder 100 of this embodiment can adapt to various application scenarios and meet various needs. When in the second locking state, since both the locking part 42 and the proximal end of the locking sleeve 80 are locked with the locking hole 31, the occluder 100 can achieve a double locking effect, improving the locking stability.

[0067] In one embodiment, the locking sleeve 80 and the locking member 40 can be fixedly connected by any suitable method such as welding, bonding, or hot melting. The locking sleeve 80 includes a connecting tube 81 and a locking tube 82. The connecting tube 81 is adapted to the shape of the connecting rod 411 and is sleeved and fixed outside the connecting rod 411. It can be understood that in other embodiments, the connecting tube 81 can be omitted, and the locking tube 82 is directly connected to the connecting rod 411. The proximal end of the connecting tube 81 is fixedly connected to the locking tube 82. The locking tube 82 is sleeved outside the connecting rod 411 and forms a radial gap with the connecting rod 411. The maximum radial dimension of the locking tube 82 is greater than the minimum diameter of the limiting hole 312, and the maximum radial dimension of the locking tube 82 is less than the maximum diameter of the receiving hole 311. In the second locking state, the locking tube 82 is located in the receiving hole 311, and the locking part 42 is partially or completely located in the receiving hole 311. The limiting hole 312 can restrict the movement of the locking part 42 and the locking tube 82 relative to the locking hole 31 towards the distal end, thereby achieving a double locking effect. The locking tube 82 can be a closed or open structure in the circumferential direction (for example, it can be formed by multiple sheet-like structures arranged at intervals along the circumference). The inner diameter of the locking tube 82 gradually decreases from the proximal end to the distal end, giving it an approximately flared shape. Due to the superior elasticity of the locking tube 82, after the occluder 100 is implanted, with the heartbeat, the locking tube 82 can offset some of the stress on the locking part 42 through its elastic deformation, thereby improving the fatigue resistance and service life of the occluder 100. Furthermore, the flared shape allows the locking tube 82 to retract from the distal end of the locking hole 31 under the action of a manual axial thrust to release the lock, improving the operational error tolerance.

[0068] The locking sleeve 80 and the locking part 42 are spaced apart axially. For example, a gap of 2mm to 4mm can be formed between the distal end of the locking sleeve 82 and the distal end of the locking part 42. During the locking process, the locking part 42 can be pulled into the locking hole 31 by the control cable 60 to form a first locking state. If it is necessary to further reduce the locking distance between the end cap 20 and the bolt head 30, the locking part 42 can be pulled further to allow the locking sleeve 82 to enter the locking hole 31 for locking, forming a second locking state. In this way, the operator can adjust the locking distance between the end cap 20 and the bolt head 30 as needed to adapt to different defects or channel lengths. In other embodiments, the interval between the locking sleeve 82 and the locking part 42 can be selected according to actual needs.

[0069] When in the first locked state, the locking tube 82 can be located on the far side of the limiting hole 312, for example, it can be located in the guide hole 313 and form a radial gap with the hole wall of the guide hole 313, or it can be located outside the locking hole 31. In this way, in the first locked state, the locking part 42 can still move axially in the receiving hole 311 under the action of external force, as described in the first embodiment, and can be radially deflected to abut against the hole wall of the receiving hole 311.

[0070] Referring to Figures 19(a) to 19(d), in another embodiment, the locking sleeve 80 is movably connected to 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 Figure 19(a), during the locking process, the locking part 42 can be pulled into the locking hole 31 by the control cable 60 to form a first locking state. If it is necessary to further reduce the locking distance between the end cap 20 and the bolt head 30, the locking part 42 can be pulled further, and after the proximal end of the locking sleeve 80 abuts against the inner wall of the locking hole 31 (refer to Figure 19(b)), as the locking part 42 continues to move towards the proximal end, the locking sleeve 80 slides on the connecting rod 411, so that the distal end of the locking sleeve 80 gradually approaches the end cap 20 until it abuts against the proximal end of the end cap 20 (refer to Figure 19(c)). Then, the locking part 42 is pulled further to allow the locking sleeve 82 to enter the locking hole 31 for locking, thus forming a second locking state (refer to Figure 19(d)).

[0071] When in the second locked state, the locking part 42 can move axially relative to the receiving hole 311 and the locking sleeve 80 under the action of external force. Therefore, even if the locking part 42 is pulled to the proximal end of the protruding plug 30 by the control cable 60 during the operation, after implantation, with the heartbeat, the locking part 42 can still move axially relative to the receiving hole 311, thereby automatically retracting into the receiving hole 311. 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 part 42, so that in the second locked state, the locking tube 82 can accommodate a portion of the locking part 42, thereby increasing the axial range of motion of the locking part 42 in the receiving cavity.

[0072] When in the first locked state, the locking tube 82 can be located on the distal side of the limiting hole 312, for example, it can be located in the guide hole 313 and form a radial gap with the hole wall of the guide hole 313, or it can be located outside the locking hole 31. This allows the locking part 42 to still move axially in the receiving hole 311 under the action of external force, as described in the first embodiment, and to be radially deflected to abut against the hole wall of the receiving hole 311, even in the first locked state. It is understood that in other embodiments, the locking part 42 may not necessarily be able to move axially in the receiving hole 311 under the action of external force, and to be radially deflected to abut against the hole wall of the receiving hole 311, even in the first locked state.

[0073] Third Embodiment See Figure 20 , Figure 21 In this embodiment, based on any of the above embodiments, the end cap 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 sealing body 10 is constricted and fixed between the first sleeve 21 and the second sleeve 22. The interior of the first sleeve 21 includes a cavity 211, which includes a limiting cavity 212. The locking member 40 includes a stabilizing part 43, which passes through the cavity 211. The maximum radial dimension of the stabilizing part 43 is greater than the minimum radial dimension of the limiting cavity 212. The limiting cavity 212 is used to restrict the stabilizing part 43 from dislodging from the proximal end of the limiting cavity 212, thereby improving the connection strength and reliability between the locking member 40 and the end cap 20.

[0074] The first sleeve 21 includes an extension tube 214 and a limiting tube 215 from the distal end to the proximal end, with the extension tube 214 located on the distal side of the limiting tube 215. For example, the proximal end of the extension tube 214 is fixedly connected to the distal end of the limiting tube 215. The extension tube 214 and the limiting tube 215 can be integrally formed, or they can be manufactured separately and then spliced ​​together. In other embodiments, the extension tube 214 and the limiting tube 215 can also be spaced apart axially, and the first sleeve 21 may also include other components.

[0075] The inner wall of the extension tube 214 forms a connecting cavity 213, and the inner wall of the limiting tube 215 forms a limiting cavity 212. The connecting cavity 213 and the limiting cavity 212 are interconnected, with the connecting cavity 213 being closer to the distal end of the occluder 100 than the limiting cavity 212. The locking member 40 also includes a connecting rod 411 connected to the proximal end of the stabilizing part 43. The connecting rod 411 passes through the limiting cavity 212, and the stabilizing part 43 is fixedly connected to the connecting cavity 213, that is, the stabilizing part 43 is fixedly connected to the extension tube 214. Since the limiting cavity 212 has a limiting effect on the stabilizing part 43, even if the fixed connection between the stabilizing part 43 and the extension tube 214 becomes loose, the limiting cavity 212 can effectively prevent the stabilizing part 43 from dislodging from the proximal end of the end cap 20, thereby reducing the risk of uncontrolled movement and tissue damage after the locking member 40 disengages from the end cap 20.

[0076] The cross-sectional shapes of the stabilizing part 43 and the extension tube 214 can be any suitable shape, such as circular, elliptical, triangular, quadrilateral, or pentagonal. The stabilizing part 43 and the extension tube 214 can be fixedly connected by welding (e.g., laser welding), hot melting, bonding, or other methods. All or part of the circumferential outer edge (or outer wall) of the stabilizing part 43 is fixedly connected to the inner wall of the extension tube 214. For example, refer to... Figure 21 , Figure 22 During manufacturing, a cylindrical rod (e.g., a cylindrical rod) can be placed as a stabilizing semi-finished product 43a within the connecting cavity 213. Laser welding is then performed along the edge of the stabilizing semi-finished product 43a, causing the edge of the stabilizing semi-finished product 43a and the inner wall of the extension tube 214 to fuse together, forming a tight and fixed connection. The laser welding points can be one or more. When there are fewer laser welding points and a larger interval between them, multiple connecting units are formed circumferentially between the stabilizing part 43 and the extension tube 214. These connecting units are formed by fusing a portion of the edge of the stabilizing semi-finished product 43a and a portion of the inner wall of the extension tube 214 together. The portion of the outer circumferential edge of the formed stabilizing part 43 is fixedly connected to the inner wall of the extension tube 214. When there are many and dense weld points in laser welding, the edge of the stabilizing part semi-finished product 43a can be completely melted and filled into the radial gap between the stabilizing part semi-finished product 43a and the extension tube 214, so that the circumferential outer edge of the stabilizing part 43 is completely fixedly connected to the inner wall of the extension tube 214, and the outer contour shape of the stabilizing part 43 matches the shape of the inner wall of the extension tube 214, thereby achieving better connection firmness and reliability.

[0077] 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 part 43 also gradually increases from the proximal end to the distal end. Compared to a structure with equal diameters, this results in a larger overall outer surface area for the stabilizing part 43 and the extension tube 214, a larger area that can be mated between the stabilizing part 43 and the extension tube 214, and a more secure fixed connection between them. Especially when using welding or hot-melt fixing methods, because the radial dimension of the connecting cavity 213 gradually increases from the proximal end to the distal end, during the welding or hot-melt process of the stabilizing part semi-finished product 43a, the molten part can better follow the guidance of the inner wall of the extension tube 214 and fill the radial gap between the stabilizing part semi-finished product 43a and the extension tube 214 more quickly, which is beneficial to improving production efficiency. In other embodiments, the connecting cavity 213 may be a structure with equal diameters, and the stabilizing part 43 may also be a structure with equal diameters (see reference). Figure 26 ).

[0078] Reference Figure 20 , Figure 21 The ratio between the maximum radial dimension of the stabilizing part 43 and the minimum radial dimension of the limiting cavity 212 ranges from 1.2 to 2. The limiting cavity 212 can be a cavity of equal diameter or a cavity of unequal diameter. This ratio range is suitable, allowing the stabilizing part 43 to better perform its limiting and secure connection functions, and also ensuring that the time and energy required to form the stabilizing part 43 through welding or hot melting are appropriate, reducing the risk of broken or damaged braided wires and / or braided strands around the end cap 20 during processing. In other embodiments, the ratio between the maximum radial dimension of the stabilizing part 43 and the minimum radial dimension of the limiting cavity 212 can be adjusted as needed.

[0079] 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, making the extension tube 214 generally funnel-shaped. This design allows the extension tube 214 to protect surrounding components during laser welding, reducing the probability of damage to these components. In particular, when the distal end of the sealing 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 effectively protects the braided wires and / or braided strands around the distal end of the end cap 20, reducing the possibility of wire breakage or damage caused by laser welding. Furthermore, during the process of retracting the distal end of the sealing body 10 into the end cap 20, the ends of the braided wires and / or braided strands of the distal end of the sealing body 10 need to be placed in the lumen of the second sleeve 22 first, and then the first sleeve 21 is inserted into the lumen of the second sleeve 22, with the ends of the braided wires and / or braided strands located between the outer wall of the first sleeve 21 and the inner wall of the second sleeve 22. The flared extension tube 214, during the insertion of the first sleeve 21, effectively prevents the ends of the braided wires and / or braided strands entering the lumen 211 of the second sleeve 22 from detaching from the second sleeve 22, and also guides the ends of the braided wires and / or braided strands to penetrate deeper into the second sleeve 22, which helps to improve the connection strength between the distal end of the sealing body 10 and the end cap 20. In other embodiments, the distal end of the extension tube 214 may also 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.

[0080] In some embodiments, the entire extension tube 214 may be located outside the second sleeve 22. In some embodiments, refer to... Figure 20 The extension tube 214 may include an inner section 2141 located within the lumen 211 of the second sleeve 22, and an extended section 2142 extending beyond the distal end of the second sleeve 22. The outer diameter of the inner section 2141 gradually increases from the proximal end to the distal end; therefore, the radial dimension of the lumen 211 in the area where the second sleeve 22 mates with it also gradually increases from the proximal end to the distal end. The extended section 2142 serves to protect the braided wires and / or braided strands around the end cap 20, while the inner section 2141 better secures and restricts the distal end of the sealing body 10, improving the connection strength between the sealing body 10 and the end cap 20. In other embodiments, the extension tube 214 may be omitted.

[0081] The maximum radial dimension of the extension tube 214 (i.e., the maximum outer diameter of the extension tube 214) is smaller 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 be in the range of 0.4 to 0.8. In other embodiments, appropriate dimensions of the extension tube 214 and the second sleeve 22 can be selected according to actual needs.

[0082] Reference Figure 21 In this embodiment, the distal end of the stabilizing portion 43 is closer to the proximal end of the plugger 100 than the distal end of the extension tube 214, thus enabling the extension tube 214 to better protect the braided wires and / or braided strands around the end cap 20. In other embodiments, the distal end of the stabilizing portion 43 may also be flush with the distal end of the extension tube 214.

[0083] Reference Figure 21 , Figure 22 In this embodiment, the distal end of the stabilizing part 43 is closer to the distal end of the plugger 100 than the distal end of the second sleeve 22. This arrangement allows for easier and more precise alignment of the distal end of the stabilizing part semi-finished product 43a during welding and heat fusion operations when assembling the locking member 40 and the end cap 20, thus improving process efficiency. In other embodiments, the distal end of the stabilizing part 43 may also be flush with the distal end of the second sleeve 22 or closer to the proximal end of the plugger 100 than the distal end of the second sleeve 22.

[0084] The aforementioned stabilizing part 43 can be a one-piece structure or a split structure.

[0085] For example, refer to Figure 21 , Figure 22 The stabilizing part 43 is an integrally formed structure, which is formed by welding or hot melting of the stabilizing part semi-finished product 43a with the same diameter as the connecting rod 411.

[0086] In another embodiment, reference is made to Figure 23 The stabilizing part 43 includes a stabilizing unit 431 and an auxiliary connecting pipe 432. The auxiliary connecting pipe 432 is sleeved outside the stabilizing unit 431 and located inside the extension tube 214. The extension tube 214 and the stabilizing unit 431 are fixedly connected by the auxiliary connecting pipe 432. The stabilizing unit 431 can be a cylindrical structure with a radial dimension consistent with that of the connecting rod 411. In other embodiments, the stabilizing unit 431 can also be any other suitable structure, and its radial dimension can be different from that of the connecting rod 411. The inner wall of the auxiliary connecting pipe 432 is fixedly connected to the outer wall of the stabilizing unit 431 by welding, hot melting, bonding, or other methods. The outer wall of the auxiliary connecting pipe 432 is fixedly connected to the inner wall of the extension tube 214. For example, please refer to laser welding. Figure 23 , Figure 24During manufacturing, the stabilizing unit 431 is first placed inside the connecting cavity 213, and then the attached pipe semi-finished product 432a is sleeved over the stabilizing unit 431. The attached pipe semi-finished product 432a is a sleeve of equal diameter. Laser welding is performed along the inner and outer edges of the attached pipe semi-finished product 432a, causing the outer edge of the attached pipe semi-finished product 432a and the inner wall of the extension tube 214 to fuse together, and the inner edge of the attached pipe semi-finished product 432a and the outer wall of the stabilizing unit 431 to fuse together, forming a tight and fixed connection. There can be one or more laser welding points. When there are few laser welding points and a large interval between them, multiple connecting units are formed circumferentially and spaced apart between the attached pipe 432 and the extension tube 214, and between the attached pipe 432 and the stabilizing unit 431. The outer circumferential region of the attached pipe 432 is fixedly connected to the inner wall of the extension tube 214, and the inner circumferential region of the attached pipe 432 is fixedly connected to the outer wall of the stabilizing unit 431. When laser welding produces numerous and dense weld points, the inner and outer edges of the auxiliary tube 432 can be completely melted and filled into the radial gap between the stabilizing unit 431 and the extension tube 214. This ensures that the outer circumferential edge of the auxiliary tube 432 is completely fixedly connected to the inner wall of the extension tube 214, and the inner circumferential edge of the auxiliary tube 432 is completely fixedly connected to the outer wall of the stabilizing unit 431. The outer contour shape of the auxiliary tube 432 matches the shape of the inner wall of the extension tube 214, for example, forming a frustum or truncated cone shape, thereby achieving better connection strength and reliability.

[0087] The maximum radial dimension of the aforementioned attached pipe 432 is greater than the minimum radial dimension of the limiting cavity 212, so that the limiting cavity 212 can effectively restrict the stabilizing part 43 from dislodging from the proximal end of the limiting cavity 212, and the locking member 40 can be firmly and stably connected to the end cap 20.

[0088] Optionally, the minimum inner diameter of the attached tube 432 is greater than the maximum radial dimension of the connecting rod 411. When the locking part 40 is made of polymer material, due to the certain light transmittance of the polymer material, during the laser welding process of the stabilizing part semi-finished product 43a and the attached tube semi-finished product 432a, the laser may penetrate the stabilizing part 43 and enter the connecting rod 411, thereby causing damage to the connecting rod 411. By setting the attached tube 432, and the minimum inner diameter of the attached tube 432 being greater than the maximum radial dimension of the connecting rod 411, during the laser welding process, the laser spot is directly incident on the attached tube 432 rather than on the stabilizing unit 431, which is coaxial with the connecting rod 411 and has the same diameter. Therefore, the laser beam will not, or has a low probability, enter the connecting rod 411, thus reducing the possibility of damage to the connecting rod 411. In other embodiments, the dimensions of the attached tube 432 and the connecting rod 411 can be adjusted according to actual needs.

[0089] Reference Figure 25Optionally, the occluder 100 further includes a developing ring 433, which is sleeved and fixed outside the stabilizing portion 43, or embedded within the stabilizing portion 43. The developing ring 433 can be made of metallic materials such as gold or platinum, or of non-metallic materials, such as sodium bromide, sodium iodide, iohexol, iodinated compounds, or barium sulfate, doped with non-metallic materials. The developing ring 433 can be manufactured through processes such as cutting, casting, or turning, or it can be woven or wound from filaments. The maximum radial dimension of the developing ring 433 is larger than that of the limiting cavity 212 (see reference). Figure 20 The minimum radial dimension of the limiting cavity 212 restricts the development ring 433 from dislodging from its proximal end. The development ring 433 not only provides good development results but also assists the stabilizing portion 43 in further enhancing the limiting and connection strength. The development ring 433 can be positioned closer to the proximal end of the plug 100 than the distal end of the stabilizing portion 43 to reduce the risk of the development ring 43 dislodging from the stabilizing portion 43. In other embodiments, the development ring 433 can be positioned at any other suitable location on the stabilizing portion 43.

[0090] Reference Figure 26 , Figure 27 In another embodiment, the locking member 40 is movably connected to the end cap 20, and the locking member 40 is axially movable relative to the end cap 20. The locking member 40 may further include a limiting portion 44 connected to the connecting rod 411, the limiting portion 44 and the stabilizing portion 43 being axially spaced apart, with the limiting portion 44 located on the proximal side of the end cap 20. The limiting portion 44 may be an annular structure or any other suitable structure. The maximum radial dimension of the limiting portion 44 is larger than that of the limiting cavity 212 (see reference). Figure 20 The minimum radial dimension of the locking member 40 is defined by the limiting cavity 212, which restricts the locking part 44 from disengaging from its distal end. The limiting part 44 and the stabilizing part 43 cooperate to limit the range of axial movement of the locking member 40 relative to the end cap 20. Since the locking member 40 can be movably connected to the end cap 20, it can undergo appropriate displacement with the heartbeat, which can reduce the stress on the locking member 40 in the body to a certain extent, thereby improving the service life of the locking member 40. The limiting part 44 and the stabilizing part 43 cooperate to limit the range of axial movement of the locking member 40, which can prevent the distal end of the locking member 40 from extending too far beyond the distal end of the end cap 20. Therefore, the locking safety and reliability of the plug 100 are improved.

[0091] The axial distance between the limiting part 44 and the stabilizing part 43 is greater than the length of the first sleeve 21. For example, the ratio between the axial distance between the limiting part 44 and the stabilizing part 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 part 44 and the stabilizing part 43, the range of movement of the locking member 40 relative to the end cap 20 can be made more suitable. The locking member 40 will not extend too far from the end cap 20 due to an excessively large range of movement, thereby affecting peripheral blood flow or puncturing surrounding tissues. Conversely, the locking member 40 will not deform or have a limited displacement range due to an excessively small range of movement, thus reducing or eliminating the stress on the locking member 40.

[0092] Reference 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 larger than that of the connecting rod 411. This arrangement allows the connecting rod 411 to have a certain radial movement space within the limiting cavity 212. Regardless of whether the stabilizing part 43 and the end cap 20 are fixedly or movably connected, the connecting rod 411 can perform a certain degree of radial movement relative to the limiting cavity 212 (see reference). Figure 29 When the location to be sealed is an inclined defect or channel (e.g., the foramen ovale typically has an inclined “tunnel”), after the occluder 100 is implanted, the locking element 40 can better adapt to the inclined defect or channel.

[0093] For example, the ratio between the radial dimension of the limiting cavity 212 and the radial dimension of the connecting rod 411 is in the range of 1.2 to 1.5. This range is suitable, which not only allows the connecting rod 411 to move radially smoothly in the limiting cavity 212, but also allows the connecting rod 411 to retain better mechanical strength.

[0094] Reference Figures 30 to 32 Optionally, in some embodiments, the locking member 40 further includes an inner hole 45 that extends axially.

[0095] For example, refer to Figure 13 In some embodiments, the inner hole 45 can penetrate the entire stabilizing part 43 and the connecting rod 411. Since the connecting rod 411 is not directly connected to the end cap 20, but is connected to the end cap 20 through the stabilizing part 43, the setting of the inner hole 45 makes the stabilizing part 43 and the connecting rod 411 have better elasticity. When the plugger 100 is locked in the extreme state (for example, when the channel to be blocked has a large tilt angle), the locking member 40 is subjected to myocardial tissue compression and delivery device traction to produce bending deformation. The setting of the inner hole 45 allows the locking member 40 to undergo elastic bending deformation to a certain extent. The deformation can offset or reduce the stress on the locking member 40 during the locking process and subsequent use, thereby improving the fatigue life of the locking member 40.

[0096] Reference Figure 31 In some embodiments, the inner bore 45 may axially penetrate the stabilizing portion 43 and continue proximally to the connecting rod 411, but only in a localized axial section of the connecting rod 411. The localized extension of the inner bore 45 in the connecting rod 411 allows for better elasticity in the distal section of the locking member 40, while the remaining area of ​​the connecting rod 411 remains a solid structure, thus providing good mechanical strength.

[0097] In some embodiments, the inner bore 45 extends only in a local axial section of the connecting rod 411, and the distal end of the inner bore 45 may extend to the stabilizing portion 43, but is closer to the proximal end of the plug 100 than the distal end of the stabilizing portion 43. This arrangement closes the distal end of the inner bore 45, that is, the distal end of the stabilizing portion 43, which not only improves the strength of the stabilizing portion 43 itself, but also makes it easier for the distal end of the end cap 20 to be covered by the endothelium, which is beneficial to improving the endothelialization speed.

[0098] 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. This arrangement ensures that the axial section of the locking member 40 with the inner hole 45 possesses both good elasticity and mechanical strength. In other embodiments, the dimensions of the inner hole 45 and the connecting rod 411 can be set according to actual needs.

[0099] In an embodiment where the inner bore 45 extends only in a localized axial section of the connecting rod 411, the proximal end of the inner bore 45 may be closer to the proximal end of the plug 100 than the proximal end of the end cap 20. (Refer to...) Figure 32 When the connecting rod 411 bends and deforms, it is prone to greater stress at the near end of the end cap 20. By providing an inner hole 45 that passes through the near end of the end cap 20, the area where the connecting rod 411 passes through the near end of the end cap 20 has better elasticity, thus effectively buffering stress in that area.

[0100] Optionally, the ratio of the length of the inner hole 45 to the length (or axial height) of the end cap 20 is in the range of 0.5 to 2. This setting allows the locking member 40 to have good elasticity and mechanical strength. In other embodiments, the lengths of the inner hole 45 and the end cap 20 can be set as needed.

[0101] Fourth embodiment Because the occluder body 10 is made of a mixture of braided filaments 101 and braided strands 102 made of biodegradable materials, and biodegradable materials are generally not visible in imaging equipment, doctors cannot identify the occluder under DSA, which brings difficulties to the interventional procedure. In order to better help doctors determine the implantation location and release pattern of the occluder 100 during the operation, this embodiment, based on any of the above embodiments, includes a radiopaque element 70 for the occluder 100.

[0102] Reference Figure 33 , Figure 34 In this embodiment, the sealing body 10 is formed by cross-weaving two extending directions (first extending direction and second extending direction) of braided material (braided filaments 101 and braided strands 102) to form a mesh tube, followed by heat setting. The braiding method of the braided material can be plain weave or twill weave, etc., to form multiple rows of intersections and multiple rows of mesh 106. The mesh 106 is surrounded by the braided material, and the intersections are formed by the cross-weaving of the braided material. Since the braided filaments 101 and braided strands 102 are mixed, there are multiple intersections, including: braided filament intersection 103 formed by the cross-weaving of braided filaments 101 in different extending directions, mixed intersection 104 formed by the cross-weaving of braided filaments 101 and braided strands 102 in different extending directions, and strand intersection 105 formed by the cross-weaving of braided strands 102 in different extending directions.

[0103] Reference Figures 33 to 35 In this embodiment, the developing element 70 can be disposed at the intersection of the sealing body 10 to reduce the risk of displacement of the developing element 70 due to the scraping of the conduit opening of the delivery device during the sheathing and unsheathing process. Exemplarily, the developing element 70 can be disposed only at the intersection of the braided filaments 103. Since the braided filaments 101 are monofilaments with better support performance, the developing element 70 disposed at the intersection of the braided filaments 103 allows the braided filaments 101 to deform better and drive the sealing body 10 to unfold during the transition from a radially compressed state to an expanded state. The developing element 70 disposed at the intersection of the braided filaments 103 is less likely to hinder the expansion and unfolding of the sealing body 10.

[0104] Reference Figures 35 to 37The developing element 70 includes a developing filament 71 and a biodegradable polymer winding 72. The developing filament 71 is wound and fixed on the cross point 103 of the braided filaments. The developing filament 71 can be made of metallic materials such as gold and platinum, or it can be made of non-metallic materials, such as sodium bromide, sodium iodide, iohexol, iodinated compounds, barium sulfate, etc., which are doped into the non-metallic filaments. There are various ways in which the developing filament 71 is wound and fixed on the cross point 103 of the braided filaments. For example, the developing filament 71 includes a filament body 711 and filament ends 712 located at both ends of the filament body 711. The filament body 711 is wound around the cross point 103 of the braided filaments multiple times (e.g., 2 to 6 times) to form a spiral tubular structure 71a. The filament body 711 in the spiral tubular structure 71a is tightly fitted, the cross point 103 of the braided filaments is located in the inner cavity of the spiral tubular structure 71a, and the two filament ends 712 are located at both ends of the spiral tubular structure 71a and are tightly pressed against the spiral tubular structure 71a. This method allows the developing filament 71 to be wound more smoothly and tightly around the braided filament intersection 103, making it less prone to displacement, and the filament ends 712 are less likely to puncture and damage tissue. Alternatively, the filament body 711 can be wound around the braided filament intersection 103 multiple times (e.g., 2-6 times) to form a spiral tubular structure 71a. The filament bodies 711 in the spiral tubular structure 71a are tightly fitted together, and the two filament ends 712 converge from both ends of the spiral tubular structure 71a towards one end and are knotted to form a developing knot 713. The developing knot 713 is located at the end of the spiral tubular structure 71a, meaning the end along its length. The developing knot 713 allows the overall volume of the shape formed by the developing filament 71 to be larger, resulting in clearer imaging. Furthermore, after blood flows in, the small gaps in the developing knot 713 can better promote blood coagulation, thus enabling the developing element 70 to endothelialize more quickly. In other embodiments, any other suitable method, such as cross-winding, can be used to wind the developing filament 71 around the intersection of the braided filaments 103. The aforementioned polymer winding thread 72 is fixed to the outside of the developing filament 71 and completely wraps around it. The polymer winding thread 72 can be a fiber strand, and can be made of biodegradable polymer materials such as polylactic acid, polydioxanone, polycaprolactone, polyurethane, and polydioxanone, or non-biodegradable polymer materials such as polyethylene terephthalate and polytetrafluoroethylene. The polymer winding thread 72 is wound around the developing filament 71, and there are various winding methods. For example, the polymer winding thread 72 includes a thread body 721 and thread ends 722 located at both ends of the thread body 721. The thread body 721 is wound around the developing filament 71 to completely wrap around the developing filament 71 and the intersection point 103 of the braided filaments within the developing filament 71. The two thread ends 722 are continuously knotted to form one or more knots 723. The number of knots 723 can be 1 to 4, for example, any one of 1, 2, 3, or 4. Multiple knots 723 help to securely finish the polymer winding 72 and prevent it from unraveling. In addition, due to the use of fiber strands, the knots 723 have more pores inside, which can better promote the endothelialization process of the developing element 70.

[0105] In this embodiment, by wrapping the surface of the imaging wire 71 with polymer-coated thread 72, the volume of the imaging element 70 is increased, resulting in better reflectivity under ultrasound. This facilitates better positioning of the occluder 100 during ultrasound-guided interventional procedures for patent foramen ovale. Furthermore, the polymer-coated thread 72 possesses good elasticity and flexibility, allowing the increased volume of the imaging element 70 to better enter and exit the delivery catheter. In addition, the polymer-coated thread 72 wrapped around the imaging wire 71 has a good endothelialization-promoting effect, enabling rapid endothelialization of the imaging element 70 and preventing the surrounding braided material from degrading and causing the imaging element 70 to detach.

[0106] After the polymer winding 72 wraps around the developing filament, the developing element 70 has a specific shape, which includes one or more of the following: spherical, cocoon-shaped, teardrop-shaped, and conical. Among these, spherical and cocoon-shaped developing elements 70, due to their smoother surfaces and more uniform dimensions in all directions, not only have better elasticity but also exhibit better reflectivity under ultrasound. In other embodiments, the developing element 70 can also be any other suitable shape.

[0107] Reference Figure 33In this embodiment, the waist portion 12 is provided with the aforementioned developing element 70, denoted as the first developing element 70a. The provision of the first developing element 70a helps the waist portion 12 to be better anchored in the narrow "tunnel" of the oval aperture. Preferably, the first developing element 70a is only provided on one radial side of the waist portion 12. Since the first developing element 70a has a large volume, if multiple first developing elements 70a are provided circumferentially, the size of the waist portion 12 will be too large and it will not be able to deform flexibly, thus causing the waist portion 12 to not adapt well to the narrow and inclined "tunnel" of the oval aperture. In addition, the control cable 60 (refer to the locking member 40 of the plugger 100) is detachably connected to the locking member 40 in the conveyor. Figure 2 Made of metallic materials (e.g., nickel-titanium alloy, stainless steel, etc.), it can be developed under imaging equipment. During implantation, the first imaging element 70a and the control cable 60 cooperate to indicate the circumferential deflection of the occluder 100. In other embodiments, the waist 12 may be provided with multiple first imaging elements 70a, or other imaging points that are not wrapped with polymer-wound wire 72.

[0108] In this embodiment, both the first sealing plate 11a and the second sealing plate 11b are provided with the aforementioned developing element 70. The developing element 70 on the first sealing plate 11a is referred to as the second developing element 70b, and the developing element 70 on the second sealing plate 11b is referred to as the third developing element 70c. Exemplarily, both second developing elements 70b are disposed at or near the edge of the first sealing plate 11a and are symmetrically arranged radially. Both third developing elements 70c are disposed at or near the edge of the second sealing plate 11b and are symmetrically arranged radially.

[0109] The structure and manufacturing method of the first developing element 70a, the second developing element 70b, and the third developing element 70c can be the same or different.

[0110] In some embodiments, the first developing element 70a, the second developing element 70b, and the third developing element 70c have the same structure and are manufactured in the same way. For example, refer to Figure 33 , Figure 36 , Figure 37In the first developing element 70a, the second developing element 70b, and the third developing element 70c, the main body 711 of the developing filament 71 is wound along the transverse direction of the braided filament intersection 103 (i.e., the circumferential direction of the blocker 100) to form a spiral tubular structure 71a. The spiral coils of the spiral tubular structure 71a are tightly arranged longitudinally. One end 712 of the developing filament 71 extends from one end of the spiral tubular structure 71a to the other end to converge with the other end 712 of the developing filament 71 and knot it to form a developing knot 713. The developing knot 713 is located at the end of the spiral tubular structure 71a, that is, in the mesh 106 adjacent to the braided filament intersection 103. The main body 721 of the polymer winding thread 72 is also wound transversely around the spiral tubular structure 71a and the developing knot 713 to completely wrap them. The two ends 722 are continuously knotted to form multiple knots 723. The two thread ends 722 can be knotted at the longitudinal end of the developing element 70 (that is, the end perpendicular to the transverse winding direction). The knot 723 and the developing knot 713 can be located at the same end or at different ends. That is, the knot 723 and the developing knot 713 are located in the same mesh 106, or in two meshes 106 adjacent to the braiding intersection and longitudinally opposite. Both the filament body 711 and the thread body 721 are wound transversely. This arrangement allows the braided filament 101 corresponding to the braiding intersection 103 of the developing element 70 to better conform to the deformation during the radial contraction of the sealing device 100, thereby achieving better sheathing. Furthermore, the development knot 713 is located at the end of the spiral tubular structure 71a, and the knot 723 is also located at the longitudinal end of the developing element 70. On the one hand, since one of the filaments 712 extends from one end of the spiral tubular structure 71a to the other end and converges with the other filament 712 of the developing wire 71 and knots it, the spiral coils of the spiral tubular structure 71a can fit together more tightly in the longitudinal direction. This not only prevents the spiral tubular structure 71a from deforming and puncturing, but also improves the developing effect of the developing wire 71. On the other hand, the development knot 713 is located at the end of the spiral tubular structure 71a and the knot 723 is located at the longitudinal end of the developing element 70. This reduces the possibility that the development knot 713 and the knot 723 will be scratched and damaged by the catheter opening and the internal components of the occluder 100 (e.g., the locking member 40) during the sheathing and unsheathing process, and also reduces the risk of the development knot 713 puncturing and damaging the tissue.

[0111] In other embodiments, the structure and manufacturing method of the first developing element 70a, the second developing element 70b, and the third developing element 70c may be different. For example, refer to Figure 33 , Figure 36 , Figure 37In the first developing element 70a, the main body 711 of the developing filament 71 is wound laterally around the intersection 103 of the braided filaments to form a spiral tubular structure 71a. The spiral coils of the spiral tubular structure 71a are tightly arranged longitudinally. One end 712 of the developing filament 71 extends from one end of the spiral tubular structure 71a to the other end to converge with the other end 712 of the developing filament 71 and knot it to form a developing knot 713. The developing knot 713 is located at the end of the spiral tubular structure 71a, that is, in the mesh 106 adjacent to the intersection 103 of the braided filaments. The main body 721 of the polymer winding thread 72 is also wound laterally around the spiral tubular structure 71a and the developing knot 713 to completely wrap them. The two ends 722 are continuously knotted to form multiple knots 723. The two thread ends 722 can be knotted at the longitudinal end of the developing element 70. The knot 723 and the developing knot 713 can be located at the same end or at different ends. That is, the knot 723 and the developing knot 713 are located in the same mesh 106, or they can be located in two meshes 106 adjacent to the braided wire intersection point 103 and longitudinally opposite each other. (Refer to...) Figure 33 , Figure 38In the second developing element 70b and / or the third developing element 70c, the main body 711 of the developing filament 71 is wound longitudinally around the intersection 103 of the braided filaments to form a spiral tubular structure 71a. The spiral coils of the spiral tubular structure 71a are tightly arranged laterally. One end 712 of the developing filament 71 extends from one end of the spiral tubular structure 71a to the other end to converge with the other end 712 of the developing filament 71 and knot it to form a developing knot 713. The developing knot 713 is located at the end of the spiral tubular structure 71a, that is, in the mesh 106 adjacent to the intersection 103 of the braided filaments. The main body 721 of the polymer winding thread 72 is also wound longitudinally around the spiral tubular structure 71a and the developing knot 713 to completely wrap them. The two ends 722 are continuously knotted to form multiple knots 723. The two thread ends 722 can be knotted at the transverse end of the developing element 70 (that is, the end perpendicular to the longitudinal winding direction). The knot 723 and the developing knot 713 can be located at the same end or at different ends. That is, the knot 723 and the developing knot 713 are located in the same mesh 106, or in two meshes 106 that are adjacent to the cross point 103 of the braided wire and are transversely opposite. When the first sealing disc 11a and / or the second sealing disc 11b have a large radial dimension (or radial width, diameter), the included angle in the longitudinal direction of the braided filament intersection 103 is usually a large angle. Correspondingly, in the second developing element 70b and / or the third developing element 70c, the filament body 711 of the developing filament 71 and the filament body 721 of the polymer winding filament 72 are wound longitudinally along the braided filament intersection 103, so that the included angle in the longitudinal direction of the braided filament intersection 103 can be expanded to a sufficiently large extent. This arrangement can avoid the deformation of the braided filament 101 connected to the developing element 70 during the expansion of the sealing device 100 due to the restriction of the developing element 70, and reduce the risk of poor forming at this point due to the fact that the included angle in the longitudinal direction of the braided filament intersection 103 connected to the developing element 70 cannot be expanded to a sufficiently large extent. Furthermore, the main body 711 of the developing filament 71 and the main body 721 of the polymer wound thread 72 are longitudinally wound along the braided filament intersection 103. During the sheathing and unsheathing process, the delivery tube scrapes the developing element 70 longitudinally along the braided filament intersection 103. The spiral coils of the spiral tubular structure 71a are tightly arranged in the transverse direction, making them less likely to be scraped, deformed, or punctured. Moreover, one of the filament heads 712 extends from one end of the spiral tubular structure 71a to the other end and converges with and knots with another filament head 712 of the developing filament 71. The filament head 712 can effectively reduce the risk of the developing knot 713 being displaced and punctured due to the scraping of the delivery tube.

[0112] In this embodiment, both the first sealing disc 11a and the second sealing disc 11b have radially symmetrical structures. (Refer to...) Figure 39In other embodiments, the first occlusion disc 11a or the second occlusion disc 11b may be an eccentric structure, meaning that 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, resulting in an offset. The foramen ovale typically has an inclined "tunnel." For some cases of patent foramen ovale with long tunnels, the radially symmetrical occlusion disc 11 may exhibit edge lifting. Using an eccentric occlusion disc 11 can reduce this edge lifting phenomenon. The first imaging element 70a may be positioned closer to the geometric center of the eccentric occlusion disc 11. The delivery conduit and control cable 60 (see reference...) Figure 2 The control cable 60, which enters the inclined "tunnel" of the oval aperture, can follow the corresponding inclination of the "tunnel" and has a developing effect, can cooperate with the first developing element 70a to indicate the direction of the eccentricity of the sealing disc 11.

[0113] Optionally, in some embodiments, the volume of the first developing element 70a may be larger than that of the second developing element 70b and the third developing element 70c to improve the anchoring effect of the first developing element 70a at the waist 12. In other embodiments, the volumes of the first developing element 70a, the second developing element 70b, and the third developing element 70c may be equal.

[0114] Optionally, in some embodiments, the polymer winding 72 may be made of a material with liquid absorption and swelling function (e.g., polyurethane foam, polyvinyl alcohol foam, poly(2-hydroxymethylpropionate) hydrogel, etc.), or a material with liquid absorption and swelling function may be embedded, so that the polymer winding 72 has the function of liquid absorption and swelling. The expanded polymer winding 72 increases the overall volume of the developing element 70. In particular, when the polymer winding 72 of the first developing element 70a has the function of liquid absorption and swelling, the first developing element 70a can play a certain flow-blocking effect after implantation and can play a better anchoring effect.

[0115] Fifth embodiment Reference Figure 40 In this embodiment, based on any of the above embodiments, the occluder 100 further includes two connecting wires 73, namely a first connecting wire 73a and a second connecting wire 73b, which are radially symmetrically arranged within the occlusion body 10. The first connecting wire 73a is connected in series with a second developing element 70b, a first developing element 70a, and a third developing element 70c on one radial side of the occlusion body 10, and the second connecting wire 73b is connected in series with a second developing element 70b and a third developing element 70c on the other radial side of the occlusion body 10.

[0116] The aforementioned connecting wire 73 has a developing function. It can be made of shape memory alloy materials such as nickel-titanium, which are then bonded with developing metal materials such as gold and platinum. Alternatively, it can be made of non-metallic materials, such as barium sulfate, sodium bromide, sodium iodide, iohexol, and iodinated derivatives, which are doped into the wire. The connecting wire 73 can be a single wire structure or multiple wires wound together.

[0117] The first occlusion disc 11a includes an integrally formed 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. The first distal disc 111 and the first proximal disc 112 both extend in a generally 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 an integrally formed 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. The second distal disc 115 and the second proximal disc 114 both extend in a generally 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 this embodiment, the overall shape and radial dimensions of the first sealing disc 11a and the second sealing disc 11b differ. In other embodiments, the shape and radial dimensions of the first sealing disc 11a and the second sealing disc 11b may be the same. The weaving method and weaving material of the waist portion 12 are basically the same as those of the first sealing disc 11a and the second sealing disc 11b. It is understood that in other embodiments, the weaving method and weaving material of the waist portion 12 may also differ from those of the first sealing disc 11a and the second sealing disc 11b, and may be designed according to actual needs.

[0118] The second developing element 70b is disposed on the first distal disc 111, and the third developing element 70c is disposed on the second proximal disc 114. The connecting wire 73 includes a waist section 732 and a first extension section 733 and a second extension section 734 disposed at opposite axial ends of the waist section 732. The waist section 732 extends axially, one end of the first extension section 733 is connected to the waist section 732, and the other end extends radially and connects to the second developing element 70b. One end of the second extension section 734 is connected to the waist section 732, and the other end extends radially and connects to the third developing element 70c. This arrangement ensures that the shape of the connecting wire 73 matches the internal contour of the sealing body 10, allowing the connecting wire 73 to clearly display the contour of the sealing device 100 under developing equipment after implantation. The waist 12 sections of the connecting wire 73 can show the tilt direction of the "tunnel" of the oval hole, and the first and second extension sections of the connecting wire 73 can show the unfolded shape of the sealing disc 11. In particular, when the sealing disc 11 is an eccentric structure, it can well indicate the eccentric direction.

[0119] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0120] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of this application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application. Therefore, the protection scope of this application should be determined by 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, 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 the direction of protrusion of the first side.

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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