Occluder and suturing method

Abstract

The present invention discloses an occluder, comprising a fixed disk, the fixed disk comprising a connecting piece and a plurality of circumferentially spaced support bodies, the plurality of support bodies radiating outward from the connecting piece and then extending toward the proximal end through bending; a film body is provided on the fixed disk, the film body at least partially covers two adjacent support bodies and the gap between the two adjacent support bodies, a peripheral suture line and a plurality of peripheral suture holes are provided on the film body along the circumference of the fixed disk, the plurality of peripheral suture holes are located on a plurality of cross sections of the fixed disk, the peripheral suture line connects the plurality of peripheral suture holes in series, and the peripheral suture line does not form a closed pattern on any cross section of the fixed disk. When the occluder of the present invention is put into a loader, the size of the fixed disk after shrinkage on a single cross section is smaller, and the peripheral suture line released is less, so that the fixed disk can be put into the loader more smoothly, reducing the possibility of the peripheral suture line being torn off.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to an occluder and a suturing method.

[0002] BACKGROUND This section merely provides background information related to the present disclosure and is not necessarily prior art.

[0003] Non-valvular Atrial Fibrillation refers to the rapid and disordered beating of the atria, which is unrelated to the ventricles. The rapid and irregular contraction and relaxation of the heart causes blood to accumulate in the left atrial appendage, and the accumulation of blood forms a blood clot. For patients with non-valvular atrial fibrillation who have a stroke, more than 90% of the blood clots come from the left atrial appendage. After the blood clots break off, they can travel throughout the body with the blood, causing cerebral embolism (stroke). In view of the risk of stroke in patients with atrial fibrillation, there are currently only three ways to prevent stroke: anticoagulant drug treatment, surgical treatment, and percutaneous left atrial appendage occlusion treatment.

[0004] Percutaneous left atrial appendage occlusion therapy refers to the use of a smaller diameter delivery sheath to deliver the left atrial appendage occluder to the left atrial appendage of the heart through percutaneous puncture and release it to block the left atrial appendage opening, thereby preventing ischemic stroke (stroke) and systemic embolism caused by the detachment of blood clots formed in the left atrial appendage of patients with atrial fibrillation, thereby playing a role in preventing stroke.

[0005] refer to Figure 1 and Figure 2 , Figure 1 is a structural schematic diagram of an existing left atrial appendage occluder in a naturally expanded state. Figure 2 for Figure 1 Schematic diagram of the left atrial appendage occluder being partially inserted into the loader. Figure 1 , Figure 2 The left atrial appendage occluder shown includes a fixed disk 11 and a sealing disk 12. The fixed disk 11 includes a plurality of support bodies 20. The plurality of support bodies 20 radiate outward from the central axis of the fixed disk 11 and then bend and extend toward the proximal end. A thin film body 10 is provided on the fixed disk 11. The thin film body 10 covers the fixed disk 11 and connects the plurality of support bodies 20 in series. The thin film body 10 is provided with a peripheral suture line 30 along the circumference of the fixed disk 11. The thin film body 10 and the peripheral suture line 30 form a restraining force on the support body 20, thereby avoiding overlapping and interlacing between the support bodies 20 on the fixed disk 11 when the left atrial appendage occluder is released. The peripheral suture line 30 is continuously routed on the thin film body 10 and surrounds the fixed disk 11 to form an annular structure. The annular structure is located on a certain cross section of the fixed disk 11.

[0006] Please refer to Figure 2When the left atrial appendage occluder is used, the left atrial appendage occluder needs to be connected to the delivery cable and stored in a loader 13. Then, the distal end of the loader 13 is connected to the proximal end of the sheath, and the left atrial appendage occluder is pushed into the sheath (not shown) along the loader 13 using the cable, and continues to be pushed toward the distal end until the left atrial appendage occluder is delivered to the lesion site for occlusion. Although the peripheral suture 30 and the film body 10 appear to fit closely together, during the process of being received into the loader 13 (or sheath), the spacing between adjacent support bodies 20 gradually becomes smaller, and wrinkles are also generated in the film body 10 between the two support bodies 20. The peripheral suture 30 that was originally in contact with the film body 10 is released outward because its length is greater than the inner circumference of the loader port or the sheath port, resulting in a large amount of wrinkled film body 10 and released peripheral suture 30 being accumulated at the loader port or the sheath port. If the film body 10 and the released peripheral suture 30 are to be completely received into the loader 13, a large friction force will inevitably be generated between the inner wall of the loader port and the released peripheral suture 30, which may cause the peripheral suture 30 to be torn off. Summary of the invention

[0007] The object of the present invention is to provide an occluder and a suturing method, so as to reduce the possibility that the peripheral suture line of the occluder is torn off during the process of receiving the occluder into a loader.

[0008] The present invention provides an occluder, comprising a fixed disk, wherein the fixed disk comprises a connecting piece and a plurality of circumferentially spaced support bodies, wherein the plurality of support bodies radiate outward from the connecting piece and then bend and extend toward the proximal end; a thin film body is provided on the fixed disk, wherein the thin film body at least partially covers two adjacent support bodies and the gap between two adjacent support bodies, and a peripheral suture line and a plurality of peripheral suture holes are provided on the thin film body along the circumference of the fixed disk, wherein the plurality of peripheral suture holes are located on a plurality of cross sections of the fixed disk, wherein the peripheral suture line connects the plurality of peripheral suture holes in series, and the peripheral suture line does not form a closed pattern on any cross section of the fixed disk.

[0009] In one embodiment, when the fixing plate is in a naturally expanded state, the peripheral suture line comprises at least one corrugated unit after being constrained by the plurality of peripheral suture holes.

[0010] In one embodiment, the shape of the waveform unit includes one or more of a V-shape, a platform shape, and an arc shape.

[0011] In one embodiment, the wave-shaped units in the peripheral suture are all V-shaped, and the wave-shaped units are composed of two sides with a common endpoint.

[0012] In one embodiment, the common endpoint is the farthest point of the waveform unit, or the common endpoint is the closest point of the waveform unit.

[0013] In one embodiment, the angle formed between the two sides ranges from 30° to 60°.

[0014] In one embodiment, the peripheral suture line includes a plurality of inner line segments; none of the inner line segments is parallel to the cross section of the fixation disc.

[0015] In one embodiment, the number of the corrugated units between two adjacent support bodies ranges from 4 to 6.

[0016] In one embodiment, the support body includes a lead-out section radiating from the connecting member toward the distal end, the lead-out section is bent and extends toward the proximal end to form a suspended supporting section, one end of the suspended supporting section is connected to the lead-out section, and the other end is a suspended end; the film body includes a main body and multiple extension parts, the main body covers at least a part of each of the suspended supporting sections, and the multiple extension parts cover the multiple suspended end parts.

[0017] In one embodiment, at least one fixing suture hole is provided on the support body, and the film body is connected to the fixing plate via a fixing suture thread passing through the fixing suture hole.

[0018] In one embodiment, the fixed suture holes include a first suture hole, a second suture hole and a third suture hole; the first suture hole is arranged on the lead-out section, and the second suture hole and the third suture hole are arranged on the suspended support section.

[0019] The present invention also provides a suturing method, which is applicable to an occluder, wherein the occluder comprises a fixing disk, the fixing disk comprises a connecting piece and a plurality of circumferentially spaced supporting bodies, the plurality of supporting bodies radiate outward from the connecting piece and then bend and extend toward the proximal end; a thin film body is provided on the fixing disk, the thin film body at least partially covers two adjacent supporting bodies and a gap between the two adjacent supporting bodies, and the suturing method comprises the following steps:

[0020] A plurality of peripheral suture holes are arranged on the film body, and a peripheral suture thread is passed through the plurality of peripheral suture holes so that the peripheral suture thread connects the plurality of peripheral suture holes in series in the circumferential direction of the fixed disk, wherein the plurality of peripheral suture holes are located on a plurality of cross sections of the fixed disk, the peripheral suture thread connects the plurality of peripheral suture holes in series, and the peripheral suture thread does not form a closed pattern on any cross section of the fixed disk.

[0021] In one embodiment, after the peripheral suture thread passes through all the peripheral suture holes, two ends of the peripheral suture thread are knotted on the inner side of the film body.

[0022] In the above technical solution, when the peripheral suture holes are located on multiple cross sections of the fixed disk, the peripheral suture lines that pass through the multiple peripheral suture holes one by one must also be located on multiple cross sections of the fixed disk. Compared with the technical solution in which the peripheral suture lines are all located on the same cross section, the length of the peripheral suture line of the occluder of the present invention on a single cross section is shorter. Therefore, during the process of being put into the loader, the size of the fixed disk on a single cross section after contraction is smaller, and fewer peripheral suture lines are released, so that the fixed disk can be more smoothly put into the loader (or sheath), reducing the possibility of the peripheral suture line being torn off. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0024] Figure 1 It is a structural schematic diagram of an existing occluder in a naturally expanded state;

[0025] Figure 2 for Figure 1 Schematic diagram of the middle occluder being partially received into the loader;

[0026] Figure 3 for Figure 1 Schematic diagram of irregular folding of the film body when the middle occluder is partially received into the loader;

[0027] Figure 4 A schematic diagram of the structure of an occluder provided in one embodiment of the present invention;

[0028] Figure 5 A schematic diagram of the structure of a fixed disk provided in one embodiment of the present invention;

[0029] Figure 6 A schematic diagram of the position of an anchor receiving portion provided by an embodiment of the present invention;

[0030] Figure 7 A schematic diagram of the structure of a thin film body provided by one embodiment of the present invention;

[0031] Figure 8 A schematic diagram of the structure of an occluder provided in another embodiment of the present invention;

[0032] Fig. 9 A schematic diagram of the routing of the peripheral suture line between two support bodies when the occluder provided by one embodiment of the present invention is in a naturally expanded state;

[0033] Fig.10 A schematic diagram of the structure of a waveform unit provided by an embodiment of the present invention;

[0034] Fig.11 A schematic diagram of the routing of the peripheral suture line between two support bodies when the occluder provided by another embodiment of the present invention is in a naturally expanded state;

[0035] Fig.12 A schematic diagram of the routing of the peripheral suture line between two support bodies when the occluder provided by another embodiment of the present invention is in a naturally expanded state;

[0036] Fig.13 A structural diagram of a waveform unit provided for another embodiment of the present invention;

[0037] Fig.14 for Figure 4 Schematic diagram of the regular folding of the film body when the middle occluder is partially received into the loader;

[0038] Fig.15 A schematic diagram of a knotting method for a peripheral suture provided in one embodiment of the present invention. DETAILED DESCRIPTION

[0039] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0040] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in a human or animal body that is closer to the operator is generally called the "proximal end", and the end that is farther from the operator is called the "distal end", and the "proximal end" and "distal end" of any component of the medical device are defined based on this principle. "Axial" generally refers to the length direction of the medical device when it is transported, and "radial" generally refers to the direction of the medical device perpendicular to its "axial direction", and the "axial" and "radial" of any component of the medical device are defined based on this principle. For sutures, "a line" refers to the entire suture that is not separated, and "segment" refers to a part of the entire suture.

[0041] Please refer to Figure 4, this embodiment provides an occluder 1, including a fixed disk 11 and a sealing disk 12. The distal end of the sealing disk 12 is connected to the fixed disk 11. In some embodiments, the sealing disk 12 may be composed of at least one metal wire (such as nickel-titanium alloy wire) with superelasticity and shape memory or a biocompatible polymer wire. After being woven into a mesh tube, the two ends of the mesh tube are respectively fixed by sleeves, and then heat-formed into a flat or disc-like shape. The shape is not limited as long as it can block the tissue opening after being implanted in the body. The sleeve located at the proximal end of the sealing disk 12 can not only converge the proximal end of the metal wire, but also be detachably connected to the distal end of the delivery device for delivering the occluder. The sleeve located at the distal end of the sealing disk 12 is not only used to converge the distal end of the metal wire, but also used to connect with the proximal end of the fixed disk 11. In other embodiments, the sealing disk 12 may also be formed of at least one metal tube with superelasticity and shape memory properties, such as a nickel-titanium alloy tube, which is heat-formed into a flat or disc-like shape after laser cutting, and its shape is not limited, as long as it can block the tissue opening after implantation in the body. The sealing disk 12 may also be formed of at least one metal rod with superelasticity and shape memory properties into a disc-like shape, and its shape is not limited, as long as it can block the tissue opening after implantation in the body.

[0042] The fixed disk 11 includes a connecting member 40 and a plurality of support bodies 20 arranged at intervals in the circumferential direction, wherein the plurality of support bodies 20 radiate outward from the connecting member 40 and then bend and extend toward the proximal end; a thin film body 10 is provided on the fixed disk 11, and the thin film body 10 at least partially covers two adjacent support bodies 20 and the gap between the two adjacent support bodies 20, and a peripheral suture line 30 and a plurality of peripheral suture holes 50 are provided on the thin film body 10 along the circumference of the fixed disk 11. The plurality of peripheral suture holes 50 can be pre-set on the thin film body 10, or formed during the routing process of the peripheral suture line 30. The plurality of peripheral suture holes 50 are located on a plurality of cross sections of the fixed disk 11, and the peripheral suture line 30 connects the plurality of peripheral suture holes 50 in series, and the peripheral suture line 30 does not form a closed pattern on any cross section of the fixed disk 11.

[0043] like Figure 4 , Figure 5 As shown, the support body 20 includes a lead-out section 210 radiating from the connection piece 40 of the fixed disk 11 toward the distal end, and the lead-out section 210 is bent and extends toward the sealing disk 12 to form a suspended support section 220, one end of the suspended support section 220 is connected to the lead-out section 210, and the other end is a suspended end 221. In addition, the suspended support section 220 is provided with an anchor barb 230 extending toward the proximal end and gradually away from the suspended support section 220, that is, there is an angle greater than 0 between the length direction of the anchor barb 230 and the length direction of the suspended support section 220. Figure 6As shown, in this embodiment, the anchor thorn 230 is formed by laser cutting a part of the suspended support section 220, so that an anchor thorn groove receiving portion 240 for receiving the anchor thorn 230 in the conveying state is formed on the corresponding part of the suspended support section 220. In this embodiment, the anchor thorn receiving portion 240 is a through-hole structure. It can be understood that in other embodiments, the anchor thorn receiving portion 240 can also be a groove structure, which is designed according to actual needs. A plurality of lead-out sections 210 constitute the lead-out portion 21, and a plurality of suspended support sections 220 constitute the anchoring portion 22. In actual production, a plurality of support bodies 20 can be cut from the end of a nickel-titanium alloy tube in a direction toward the other end, and then each support body 20 is propped open by a mold and heat-treated to shape. Among them, the uncut portion of the nickel-titanium alloy tube can be reserved as a connector 40 for connecting the sealing disk 12.

[0044] The support body 20 may also be made of at least one metal wire (such as nickel-titanium wire) having superelasticity and shape memory properties. Specifically, the support body 20 may be a single metal wire, or may be formed by winding or weaving two or more metal wires; one end of the plurality of support bodies 20 is connected to a matching connector 40, and the sealing disk 12 is connected through the connector 40, and the remaining part is heat-formed into an umbrella shape, thereby obtaining a fixed disk 11 having a lead-out portion 21 and an anchor portion 22.

[0045] In other embodiments, the fixing disk 11 can also be made of a trumpet-shaped or tubular elastic material that is cut and then heat-set into an umbrella shape, thereby obtaining a fixing disk 11 having a lead-out portion 21 and an anchor portion 22. The end of the elastic material with a smaller outer diameter is provided with a connector 40 for connecting to the sealing disk 12, and the portion of the elastic material other than the connector 40 is a support body 20, which occupies most of the elastic material, and the suspended portion obtained by cutting is the suspended support section 220.

[0046] In other embodiments, the support body 20 radiates from the connecting member 40 in parallel, bends outward and extends toward the sealing disk 12, and can also form a plurality of mutually separated suspended support segments 220. Here, the specific conditions after at least one support body 20 radiates from the center are not listed one by one, as long as it can form a plurality of mutually separated suspended support segments 220 after extending toward the sealing disk 12.

[0047] In some embodiments, the film body 10 disposed on the fixed disk 11 can completely cover the outer surface of the fixed disk 11 from the distal end to the proximal end of the fixed disk 11, that is, along the circumferential direction of the fixed disk 11, each adjacent support body 20 is covered by the film body 10, and the gap between each adjacent support body 20 is also covered by the film body 10.

[0048] In other embodiments, the film body 10 may also partially cover the gaps between the two adjacent support bodies 20 and the two adjacent support bodies 20. For example, the film body 10 may be an annular film, and the band-shaped film only covers a portion of the anchoring portion 22, or the annular film completely covers the anchoring portion 22 but does not cover the lead-out portion 21.

[0049] The film body 10 can be made of materials such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), silicone, etc., or other materials with required biocompatibility and physical properties. The film body 10 can be fixed on the support body 20 by suturing. It is understandable that in other embodiments, the film body 10 can also be fixed on the support body 20 by gluing or bonding.

[0050] like Figure 5 , Figure 6 As shown, in some embodiments, at least one fixing suture hole 23 is provided on the support body 20. The fixing suture hole 23 includes a first suture hole 231, a second suture hole 232, and a third suture hole 233. The first suture hole 231 is provided in the lead-out section 210. The second suture hole 232 and the third suture hole 233 are provided in the suspended support section 220. The fixing suture thread can pass through the portions of the film body 10 corresponding to the first suture hole 231, the second suture hole 232, and the third suture hole 233, respectively, and single-point suture is performed on each fixing suture hole 23 (i.e., the film body 10 is sutured with the fixing suture thread at one suture hole and then knotted, the suture thread is cut, and the suture is performed on the next suture point), so as to be fixed on the lead-out section 210 and the suspended support section 220 and cover the lead-out portion 21 and the anchor portion 22, wherein the suspended end portion 221 of the anchor portion 22 is also covered. Preferably, the anchor thorn receiving portion 240 of the anchoring portion 22 is located at the suspended support section 220, and the second suture hole 232 and the third suture hole 233 are located at both ends of the anchor thorn receiving portion 240. At this time, the second suture hole 232 and the third suture hole 233 are symmetrically arranged relative to the anchor thorn receiving portion 240. After the corresponding parts of the film body 10 are fixed at both ends of the anchor thorn receiving portion 240, it can ensure that the connection is uniformly stressed and the stability of the connection is improved. It should be understood that the fixed suture referred to in the present invention can be a continuous unbroken suture or a broken suture, but the suture position of the suture is the same. For example, the film body 10 and the fixed disk 11 are sutured with sutures at the fixed suture holes 23.

[0051] refer to Figure 7The film body 10 includes a main body 310 and a plurality of extensions 320. The main body 310 is generally circular. The plurality of extensions 320 are connected to the edge of the main body 310 and are arranged at intervals along the circumference of the main body 310. The extensions 320 extend from the outer edge of the film body 10, so that the film body 10 can be formed into a flower-like structure. The number and distribution positions of the extensions 320 correspond to the number and distribution positions of the suspended support segments 220. Please also refer to Figure 5 , Figure 8 The main body 310 has a large area, at least covering a portion of each suspended support segment 220, and the multiple extensions 320 of the thin film body 10 cover multiple suspended ends 221. After the thin film body 10 covers the suspended ends 221 of the anchoring portion 22, the thin film body 10 will isolate the suspended ends 221 from the inner wall of the heart, reducing the stimulation of the suspended ends 221 directly exposed after the occluder enters the left atrial appendage to the inner wall of the heart. And after the suspended ends 221 of this embodiment are covered by the thin film body 10, not only can the stimulation to the tissue and blood be reduced, but also the overall size of the suspended ends 221 can be increased. When the occluder 1 is not released ideally, it is more conducive to partially recovering the occluder 1 and effectively adjusting the position. It should be understood that although the suspended end 221 on the occluder 1 of the present invention covers the thin film body 10 and the fixed disk 11 is partially released, the suspended end 221 will still hook the pectinate muscles of the heart, but because the overall size of the suspended end 221 becomes larger and the thin film body 10 is softer than the suspended end 221, the difficulty of subsequent recovery and adjustment is greatly reduced.

[0052] It should be noted that the “coating” referred to in the present invention means that when the surface of object A is completely covered by object B, it can be called “object B covers object A” or “object A is covered by object B”. When object B only covers part of the surface of object A, it is not the “coating” referred to in the present invention.

[0053] Please refer again Figure 4 In some embodiments, the peripheral suture 30 may be continuously routed on the film body 10 and at least surround the periphery of the fixing plate 11. In other embodiments, the peripheral suture 30 may only partially surround the periphery of the fixing plate 11. The present invention defines "continuously routed" as the suture passing through at least three consecutive suture holes of the same suture (such as the film body 10) without interruption, that is, the suture passing through the three consecutive suture holes on the same suture body is the same continuous unbroken suture.

[0054] After the occluder 1 is implanted in the body, when it is squeezed by the inner wall of the left atrial appendage, due to the "convex part" or "concave part" that may exist on the inner wall of the left atrial appendage, a certain support body 20 may be greatly deformed, so that the force generated by the deformation of the support body 20 acts on the inner wall of the left atrial appendage in contact with the support body 20, which may cause damage to the inner wall of the left atrial appendage, thereby forming effusion. When the peripheral suture 30 completely surrounds the outer circumference of the fixing plate 11, a nearly ring-shaped structure is formed, which can realize the constraint of each support body 20, and when a certain support body 20 is deformed, the force can be dispersed to the adjacent support body 20 through the peripheral suture 30, reducing the possibility of damage to the inner wall of the left atrial appendage, thereby reducing the risk of effusion. Of course, the more circles the peripheral suture 30 wraps around the periphery of the fixed disk 11, the stronger the restraint force on the support body 20 will be. However, too many circles will not only increase the complexity and cost of the process, but may also cause the size of the fixed disk 11 to be too large after radial compression, thereby increasing the difficulty of storing the fixed disk 11 in the loader 13 (or sheath).

[0055] When the fixed disk 11 is in a naturally expanded state (the so-called naturally expanded state refers to a naturally stretched state without being subjected to artificial external forces), the peripheral suture 30 is constrained into a predetermined shape by a plurality of peripheral suture holes 50. The peripheral suture 30 can be located between the anchor barb 230 and the proximal edge of the film body 10, which is conducive to providing a larger radial restraining force. Among them, the peripheral suture 30 includes a plurality of outer line segments (solid line segments in the figure, the same below) and a plurality of inner line segments (dashed line segments in the figure, the same below), the inner line segment refers to the line segment located inside the film body 10 when the fixed disk 11 is in a naturally expanded state; the outer line segment refers to the line segment exposed outside the film body 10 when the fixed disk 11 is in a naturally expanded state.

[0056] Please also refer to Figure 5 , 6 In some embodiments, the peripheral suture 30 can pass through the anchor thorn receiving portion 240 of the anchoring portion 22. Since the anchor thorn 230 of the anchoring portion 22 is located on the anchoring portion 22, the peripheral suture 30 can form a stable connection effect between the film body 10 and the fixing plate 11, and the force at each part of the connection portion is uniform. When passing through the anchor thorn receiving portion 240, the peripheral suture 30 can be pressed under the anchor thorn 230, so that the corresponding part of the peripheral suture 30 can be fixed, thereby improving the stable connection of the film body 10.

[0057] In other embodiments, when the peripheral suture 30 is routed on the film body 10 to the vicinity of a support body 20, it goes around the inner surface of the support body 20 (i.e., the side of the support body 20 facing the central axis of the fixed disk 11 when the fixed disk 11 is in a naturally unfolded state), and then extends on the inner surface of the support body 20 and then returns to the film body 10 to continue routing, so as to further fix the film body 10 and the support body 20 through the peripheral suture 30.

[0058] In other embodiments, the peripheral suture 30 may not pass through the anchor thorn receiving portion 240 of the anchor portion 22, and the peripheral suture 30 is located on the outside of the support body 20 (i.e., when the fixed disk 11 is in a naturally expanded state, the support body 20 is on the side facing away from the central axis of the fixed disk 11).

[0059] In some embodiments, when the fixation disc 11 is in a naturally expanded state, the peripheral suture 30 is in a spiral shape.

[0060] In other embodiments, when the fixing plate 11 is in a naturally expanded state, the peripheral suture line 30 includes at least one corrugated unit 31. The shape of the corrugated unit 31 can be one or more of a V-shape, a platform shape, an arc shape, or any other suitable shape. Figure 4 The above-mentioned waveform units 31 can be arranged continuously, that is, adjacent waveform units 31 are directly connected; the above-mentioned waveform units 31 can also be arranged at intervals, such as Fig. 9 As shown, adjacent wave-shaped units 31 are connected by a connecting line segment 32 , and the connecting line segment 32 is a segment of the peripheral suture line 30 .

[0061] Please refer to Fig. 9 In some embodiments, when the fixing plate 11 is in a naturally expanded state, the peripheral suture 30 surrounds the outer circumference of the fixing plate 11, and the peripheral suture 30 includes a plurality of platform-shaped wave-shaped units 31a arranged at intervals. Fig.10The platform-shaped corrugated unit 31a is composed of three sides, wherein the first end of the first side 311 is connected to the first end of the second side 312, and the connection between the first end of the first side 311 and the first end of the second side 312 forms a first common endpoint, the second end of the second side 312 is connected to the first end of the third side 313, and the connection between the second end of the second side 312 and the first end of the third side 313 forms a second common endpoint, the second side 312 is not parallel to the first side 311, and the second side 312 is not parallel to the third side 313, and the second end of the first side 311 and the second end of the third side 313 are both located on the same side of the second side 312. The second side 312 of each platform-shaped corrugated unit 31a is located on the first cross section of the fixed disk 11, and the connecting line segment 32 between two adjacent corrugated units is located on the second cross section of the fixed disk 11. In other embodiments, in order to further reduce the total length of the peripheral suture 30 on the first cross-section and the second cross-section, the total length of the line segments of the peripheral suture 30 on the first cross-section and the total length of the line segments of the peripheral suture 30 on the second cross-section can be made less than or equal to the inner circumference of the loader port (the inner circumference of the loader port and the sheath port used for the same specification of the occluder 1 are equal). At this time, the length of the peripheral suture 30 that can be released on the cross-section is almost 0. In the process of putting the fixed disk 11 into the loader 13 or the sheath, the friction or pulling of the loader port or the sheath port on the peripheral suture 30 can be reduced to a greater extent, and the size of the fixed disk 11 in the radially compressed state on the first cross-section and the second cross-section can be made smaller.

[0062] The length of the releasable peripheral suture 30 on a certain cross section is calculated as follows: when the total length of the peripheral suture 30 on the cross section is greater than or equal to the inner circumference of the loader port, the difference between the total length of the peripheral suture 30 on the cross section and the loader port is the length of the releasable peripheral suture 30; when the total length of the peripheral suture 30 on the cross section is less than the inner circumference of the loader port, the length of the releasable peripheral suture 30 is 0.

[0063] When the fixed disk 11 is in a naturally unfolded state, the line segments of the peripheral suture 30 on the first cross section and the second cross section are all located outside the fixed disk 11. Since the proximal end of the suspended support segment 220 of the support body 20 is flipped toward the distal end during the process of receiving the fixed disk 11 into the loader port or the sheath port, the line segments of the peripheral suture 30 on the film body 10 and the first cross section and the second cross section are also flipped to the inside of the fixed disk 11. At this time, the line segment length of the peripheral suture 30 on the first cross section and the second cross section that contacts the loader port or the sheath port is reduced to the shortest (almost 0), further reducing the probability of friction or pulling of the peripheral suture 30 by the loader port or the sheath port.

[0064] Please refer to Fig.11 In some embodiments, when the fixed disk 11 is in a naturally expanded state, the peripheral suture 30 surrounds the outer circumference of the fixed disk 11, and the peripheral suture 30 includes a plurality of continuously arranged platform-shaped corrugated units 31a. The second side 312 of each platform-shaped corrugated unit 31a is located on the third cross section of the fixed disk 11. When the fixed disk 11 is in a naturally expanded state, the total length of the line segment of the peripheral suture 30 on the third cross section is less than or equal to the inner circumference at the loader port, so that the length of the peripheral suture 30 that can be released on the third cross section is almost 0. In addition, by reducing the total length of the line segment of the peripheral suture 30 located on the inner side of the fixed disk 11 on the third cross section, the probability of friction or pulling of the peripheral suture 30 by the loader port or the sheath port can be further reduced.

[0065] Please refer to Fig.12 In some embodiments, when the fixing plate 11 is in a naturally expanded state, the peripheral suture 30 surrounds the outer circumference of the fixing plate 11, and the peripheral suture 30 includes a plurality of continuously arranged platform-shaped corrugated units 31a and V-shaped corrugated units 31b. The second side 312 (refer to Fig.10 ) are located on the third cross section of the fixed disk 11. Figure 3 The platform-shaped corrugated units 31a are continuously arranged in the middle, and the total length of the line segment of the peripheral suture line 30 on the third cross section can be further reduced by combining and arranging the platform-shaped corrugated units 31a and the V-shaped corrugated units 31b. Fig.13 The V-shaped waveform unit 31b is composed of two sides having a first common endpoint, and an angle is formed between the two sides. The third common endpoint 314 is the farthest point of the V-shaped waveform unit 31b, or the third common endpoint 314 is the closest point of the V-shaped waveform unit 31b.

[0066] In other embodiments, all inner line segments in the peripheral suture 30 are not parallel to the cross-section of the fixation disk 11. For example, the angles between all inner line segments in the peripheral suture 30 and the cross-section of the fixation disk 11 are greater than or equal to 30°, thereby further reducing the length of the inner line segments on a single cross-section of the fixation disk 11.

[0067] Please refer again Figure 4In some embodiments, the peripheral suture 30 surrounds the periphery of the fixed disk 11, and the peripheral suture 30 includes a plurality of V-shaped waveform units 31b arranged in a row. In this embodiment, the waveform units 31 of the peripheral suture 30 are arranged in a row, so that the length of the peripheral suture 30 on each cross section of the fixed disk 11 is greatly reduced, thereby reducing the friction or pulling of the peripheral suture 30 by the loader port or the sheath port. Since the waveform units 31 are all V-shaped, the peripheral suture 30 can guide and restrain the film body 10 during the process of placing the fixed disk 11 into the loader 13 or the sheath. Fig.14 As shown, the film body 10 can be folded into a wave-like shape along the V-shaped corrugated unit 31b, wherein the crest or trough of the wave shape is at the third common end point 314 of the two sides of the V-shaped corrugated unit 31b. Figure 3 In the prior art shown, during the process of the fixed disk 11 being received into the loader 13 (or sheath tube), the film body 10 is stacked in large quantities in a disordered manner at the loader port. The technical solution of this embodiment can further reduce the size of the fixed disk 11 after shrinkage, thereby making it easier for the fixed disk 11 to be received into the loader 13 or sheath tube, and can also reduce the contact area between the film body 10 and the loader port or sheath tube port, thereby reducing the probability of damage to the film body 10 caused by mutual friction between the film body 10 and the loader port or sheath tube port.

[0068] It should be noted that in the present embodiment, if there are too few V-shaped corrugated units 31b between two adjacent support bodies 20, or the angle between the two sides of the V-shaped corrugated unit 31b (such as angle ABC) is too large, the film body 10 will not be able to be folded into a wave-like shape along the V-shaped corrugated unit 31b during the process of receiving the fixed disk 11 into the loader 13 or the sheath tube port, or the film body 10 will be folded too few times, so that the effect of reducing the probability of damage to the film body 10 is not obvious; if there are too many V-shaped corrugated units 31b between two adjacent support bodies 20, or the angle between the two sides of the V-shaped corrugated unit 31b (such as angle ABC) is too small, the length of the peripheral suture 30 that can be released on a partial cross section will increase, thereby increasing the friction or pulling of the peripheral suture 30 on the partial cross section by the loader port or the sheath tube port. Therefore, in this embodiment, the angle between the two sides of the V-shaped waveform unit 31b ranges from 30° to 60°, and the number of V-shaped waveform units 31b between two adjacent support bodies 20 is 4 to 6. By reasonably setting the angle between the two sides of the V-shaped waveform unit 31b and the number of V-shaped waveform units 31b, the probability of friction and pulling between the film body 10 and the peripheral suture 30 and the loader port or sheath port can be reduced at the same time. Further, when the lengths of the two sides in the V-shaped waveform unit 31b are equal, the film body 10 can be constrained and guided by the peripheral suture 30 to fold into a more regular wave shape, thereby further reducing the probability of friction and pulling between the film body 10 and the loader port or sheath port.

[0069] The present invention also provides a suturing method, comprising the following steps: providing peripheral suturing holes 50 on the film body 10, and passing the peripheral suturing thread 30 through the peripheral suturing holes 50, so that the peripheral suturing thread 30 connects a plurality of peripheral suturing holes 50 in series in the circumferential direction of the fixed disk 11, wherein the plurality of peripheral suturing holes 50 can be pre-disposed on the film body 10, or can be formed during the routing process of the peripheral suturing thread 30. The plurality of peripheral suturing holes 50 are located on a plurality of cross sections of the fixed disk 11, the peripheral suturing thread 30 connects the plurality of peripheral suturing holes 50 in series, and the peripheral suturing thread 30 does not form a closed pattern on any cross section of the fixed disk 11.

[0070] by Figure 4 Taking the V-shaped corrugated unit 31b shown in as an example, the above-mentioned suturing method can be specifically described as follows: one end of the peripheral suture line 30 is passed through the film body 10 from position A ("passing through" means passing through the film body 10 from the inner side of the film body 10 to the outer side of the film body 10), and then passed through the film body 10 from position B ("passing through" means passing through the film body 10 from the outer side of the film body 10 to the inner side of the film body 10), and passed out from position C to form a V-shaped corrugated unit 31b; then, continue to pass through from position D and pass out from position E to form a second V-shaped corrugated unit 31b, continue this routing method, and form a plurality of continuously arranged V-shaped corrugated units 31b around the circumference of the fixed disk 11, and there are 5 V-shaped corrugated units 31b between two adjacent support bodies 20; finally, tighten the two ends of the peripheral suture line 30 and tie a knot at position A. The specific knotting method can be referred to Fig.15 The "penetration" or "penetration" positions A to K on the film body 10 form corresponding peripheral suture holes 50, and the distance between points A and K is about 15 mm.

[0071] More specifically, after the two ends of the peripheral suture 30 are gathered and knotted, the excess peripheral suture 30 is cut off, and a hot melt device (such as an electric soldering iron, etc.) is used to melt the thread ends of the peripheral suture 30 to 0.5 mm to 1.5 mm away from the knot position. It should be noted that the knot point formed by the knotting should be on the inner side of the film body 10 and not exposed to the outside, so as to avoid the exposed knot point causing thrombosis.

[0072] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An occluder, comprising a fixed disk, the fixed disk comprising a connecting member and a plurality of circumferentially spaced support bodies, the plurality of support bodies radiating outward from the connecting member and then extending toward the proximal end by bending, the support body comprising a lead-out section radiating from the connecting member toward the distal end, the lead-out section extending toward the proximal end by bending to form a suspended support section, the suspended support section being provided with anchor spikes extending toward the proximal end and gradually away from the suspended support section; the fixed disk is provided with a film body, the film body at least partially covers two adjacent support bodies and a gap between two adjacent support bodies, characterized in that A peripheral suture line and a plurality of peripheral suture holes are provided on the film body along the circumference of the fixed disk, the peripheral suture line is located between the anchor barb and the proximal edge of the film body, the peripheral suture line is continuously routed on the film body and surrounds at least one periphery of the fixed disk, a plurality of the peripheral suture holes are located on a plurality of cross sections of the fixed disk, the peripheral suture line connects a plurality of the peripheral suture holes in series, and the peripheral suture line does not form a closed figure on any cross section of the fixed disk, and when the fixed disk is in a naturally expanded state, the peripheral suture line includes at least one corrugated unit after being constrained by the plurality of peripheral suture holes, and the number of corrugated units between two adjacent support bodies ranges from 4 to 6.

2. The occluder according to claim 1, characterized in that: The anchor barb is formed by laser cutting a portion of the suspended supporting section, and an anchor barb receiving portion for receiving the anchor barb in a conveying state is formed on the suspended supporting section. The anchor barb receiving portion is a through-hole structure or a groove structure, and the peripheral suture thread passes through the anchor barb receiving portion and is pressed under the anchor barb.

3. The occluder according to claim 1, characterized in that: The shape of the wave-shaped unit includes one or more of a V-shape, a platform shape, and an arc shape.

4. The occluder according to claim 1, characterized in that: The waveform units are all V-shaped and consist of two sides with a common endpoint.

5. The occluder according to claim 4, characterized in that: The common endpoint is the farthest point of the waveform unit, or the common endpoint is the closest point of the waveform unit.

6. The occluder according to claim 4, characterized in that: The angle between the two sides ranges from 30° to 60°.

7. The occluder according to any one of claims 1 to 6, characterized in that: The peripheral suture line includes multiple inner line segments and multiple outer line segments. The inner line segments refer to the line segments located inside the film body when the fixed disk is in a naturally expanded state; the outer line segments refer to the line segments exposed outside the film body when the fixed disk is in a naturally expanded state; the inner line segments are not parallel to the cross-section of the fixed disk.

8. The occluder according to any one of claims 1 to 6, characterized in that: When the fixed disk is in a naturally expanded state, the peripheral suture line includes a plurality of spaced-apart platform-shaped corrugated units, the platform-shaped corrugated unit consisting of three sides, wherein the first end of the first side of the platform-shaped corrugated unit is connected to the first end of the second side, the second end of the second side is connected to the first end of the third side, the second side is not parallel to the first side, the second side is not parallel to the third side, the second end of the first side and the second end of the third side are both located on the same side of the second side; the second side of each of the platform-shaped corrugated units is located on the first cross section of the fixed disk, and the connecting line segments between two adjacent corrugated units are both located on the second cross section of the fixed disk, the total line length of the peripheral suture line on the first cross section and the total line length of the peripheral suture line on the second cross section are both less than or equal to the inner circumference of the loader port; or, The peripheral suture line includes a plurality of continuously arranged platform-shaped corrugated units, the second side of each of the platform-shaped corrugated units is located on the third cross section of the fixing plate, and the total length of the line segments of the peripheral suture line on the third cross section is less than or equal to the inner perimeter at the loader port; or, The peripheral suture line includes a plurality of continuously arranged platform-shaped corrugated units and V-shaped corrugated units, and the second side of each of the platform-shaped corrugated units is located on the third cross section of the fixing plate.

9. The occluder according to any one of claims 1 to 6, characterized in that: One end of the suspended support section is connected to the lead-out section, and the other end is a suspended end portion; the film body includes a main body and a plurality of extension portions, the main body at least covers a portion of each of the suspended support sections, and the plurality of extension portions cover the plurality of suspended end portions.

10. The occluder according to any one of claims 1 to 6, characterized in that: The support body is provided with at least one fixing suture hole, and the film body is connected to the fixing plate via a fixing suture thread penetrating the fixing suture hole.

11. The occluder according to claim 10, characterized in that: The fixed suture holes include a first suture hole, a second suture hole and a third suture hole; the first suture hole is arranged on the lead-out section, the second suture hole and the third suture hole are arranged on the suspended support section, the anchor barb is formed by laser cutting a part of the suspended support section, and an anchor barb receiving portion for receiving the anchor barb in a conveying state is formed on the suspended support section, the anchor barb receiving portion is a through hole structure or a groove structure, and the second suture hole and the third suture hole are located at both ends of the anchor barb receiving portion.

12. A suturing method, the suturing method is applicable to an occluder, the occluder comprises a fixing disk, the fixing disk comprises a connecting member and a plurality of circumferentially spaced support bodies, the plurality of support bodies radiate outward from the connecting member and then extend toward the proximal end by bending, the support body comprises a lead-out section radiating from the connecting member toward the distal end, the lead-out section extends toward the proximal end by bending to form a suspended support section, the suspended support section is provided with anchor thorns extending toward the proximal end and gradually away from the suspended support section; the fixing disk is provided with a film body, the film body at least partially covers two adjacent support bodies and the gap between two adjacent support bodies, characterized in that The suturing method comprises the following steps: Peripheral suture holes are provided on the film body, and peripheral suture threads are passed through the peripheral suture holes so that the peripheral suture threads connect multiple peripheral suture holes in series in the circumferential direction of the fixed disk, the peripheral suture threads are located between the anchor barb and the proximal edge of the film body, the peripheral suture threads are continuously routed on the film body and surround the periphery of the fixed disk at least once, wherein multiple peripheral suture holes are located on multiple cross sections of the fixed disk, the peripheral suture threads connect the multiple peripheral suture holes in series, and the peripheral suture threads do not form a closed figure on any cross section of the fixed disk, and when the fixed disk is in a naturally expanded state, the peripheral suture threads are constrained by the multiple peripheral suture holes to include at least one corrugated unit, and the number of corrugated units between two adjacent support bodies ranges from 4 to 6.

13. The suturing method according to claim 12, characterized in that: After the peripheral suture thread passes through all the peripheral suture holes, two ends of the peripheral suture thread are knotted on the inner side of the film body.

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