CN114680989A

CN114680989A - Occluder and suturing method

Info

Publication number: CN114680989A
Application number: CN202011643996.XA
Authority: CN
Inventors: 肖本好; 刘希尧; 何里明; 吴维; 贾小乐
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2020-12-30
Filing date: 2020-12-30
Publication date: 2022-07-01

Abstract

The invention discloses a plugging device which comprises a fixed disc, wherein the fixed disc comprises a connecting piece and a plurality of supporting bodies which are arranged at intervals in the circumferential direction, and the plurality of supporting bodies radiate outwards from the connecting piece and extend towards the near end through bending; the fixed disk is provided with a film body, the film body at least partially covers two adjacent supporting bodies and a gap between the two adjacent supporting bodies, peripheral sewing threads and a plurality of peripheral sewing holes are arranged on the film body along the circumferential direction of the fixed disk, the plurality of peripheral sewing holes are located on a plurality of cross sections of the fixed disk, the peripheral sewing threads connect the plurality of peripheral sewing holes in series, and the peripheral sewing threads do not form a closed figure on any cross section of the fixed disk. In the process of taking in the stopper, the size of the fixed disk on a single cross section is smaller after the fixed disk is contracted, and fewer peripheral sutures are released, so that the fixed disk can be more smoothly taken in the stopper, and the possibility that the peripheral sutures are pulled apart is reduced.

Description

Occluder and suturing method

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to an occluder and a suturing method.

Background this section provides background information related to the present disclosure only and is not necessarily prior art.

Non-valvular Atrial Fibrillation (Non-valvular Atrial Fibrillation) refers to the rapid and chaotic beating of the atria, independent of the ventricles. The rapid and irregular systolic relaxation of the heart causes pooling of blood within the left atrial appendage, which pooling of blood forms a thrombus. For stroke patients with non-valvular atrial fibrillation, more than 90% of thrombi originate from the left atrial appendage, and after falling off, the thrombi can go everywhere along with the blood to cause cerebral embolism (stroke). Aiming at the risk of stroke of patients with atrial fibrillation, the current stroke prevention modes only have three types: anticoagulant drug therapy, surgical treatment and percutaneous left atrial appendage occlusion therapy.

Percutaneous left atrial appendage plugging treatment refers to that a left atrial appendage plugging device is conveyed to a left atrial appendage located in a heart and released by a conveying sheath tube with a smaller diameter in a percutaneous puncture mode to plug the mouth of the left atrial appendage, so that ischemic stroke (apoplexy) and systemic embolism caused by thrombus formed in the left atrial appendage of an atrial fibrillation patient are prevented from falling off, and the effect of preventing stroke is achieved.

Referring to fig. 1 and 2, fig. 1 is a schematic structural view of a conventional left atrial appendage occluder in a natural deployment state, and fig. 2 is a schematic view of the left atrial appendage occluder partially received in a loader in fig. 1. The left atrial appendage occluder shown in fig. 1 and 2 comprises a fixed disk 11 and a sealing disk 12, the fixed disk 11 comprises a plurality of support bodies 20, the support bodies 20 radiate outwards from the central axis of the fixed disk 11 and extend towards the near end through bending, a film body 10 is arranged on the fixed disk 11, the film body 10 covers the fixed disk 11 and is connected with the support bodies 20 in series, a peripheral suture line 30 is arranged on the film body 10 along the circumferential direction of the fixed disk 11, the film body 10 and the peripheral suture line 30 form a restraining force for the support bodies 20, and overlapping and staggering of the support bodies 20 on the fixed disk 11 when the left atrial appendage occluder is released are avoided. The peripheral seam 30 is continuously routed on the film body 10 around the fixing plate 11 to form a ring structure, and the ring structure is located on a certain cross section of the fixing plate 11.

Referring to fig. 2, when the left atrial appendage occluder is used, the left atrial appendage occluder needs to be connected with a conveying steel cable and put into a loader 13. Subsequently, the distal end of the loader 13 is connected to the proximal end of the sheath, and the left atrial appendage occluder is pushed along the loader 13 into the sheath (not shown) using a wire cable, and is further pushed distally until the left atrial appendage occluder is delivered to the lesion site for occlusion. Although the peripheral suture line 30 seems to be attached to the thin film body 10, in the process of receiving the loading device 13 (or the sheath), the distance between the adjacent supporting bodies 20 gradually decreases, and the thin film body 10 between the two supporting bodies 20 is also wrinkled, the peripheral suture line 30 originally attached to the thin film body 10 is longer than the inner circumference of the loading device opening or the sheath opening, and is released outward, so that a great amount of wrinkled thin film body 10 and released peripheral suture line 30 are accumulated at the loading device opening or the sheath opening, if the thin film body 10 and released peripheral suture line 30 are completely received in the loading device 13, the inner wall of the loading device opening and the released peripheral suture line 30 inevitably generate a large friction force, and the peripheral suture line 30 may be torn off.

Disclosure of Invention

The invention aims to provide an occluder and a suturing method, which can reduce the possibility that peripheral suture is torn off in the process of taking the occluder into a loader.

The invention provides an occluder, which comprises a fixed disk, wherein the fixed disk comprises a connecting piece and a plurality of supporting bodies which are circumferentially arranged at intervals, and the supporting bodies radiate outwards from the connecting piece and then extend towards a near end through bending; be equipped with the film body on the fixed disk, the film body at least part covers two adjacent supporter and two are adjacent clearance between the supporter, the film body is gone up along the circumference of fixed disk is equipped with periphery suture and a plurality of periphery and sews up the hole, and is a plurality of the periphery is sewed up the hole and is located on a plurality of cross sections of fixed disk, the periphery suture will be a plurality of the periphery is sewed up the hole and is established ties, just is in on the arbitrary cross section of fixed disk the periphery suture does not all form closed figure.

In one embodiment, the peripheral suture line comprises at least one wave shaped unit constrained by the plurality of peripheral suture holes when the fixation disk is in a naturally expanded state.

In one embodiment, the shape of the wave shaped unit comprises one or more of a V shape, a plateau shape, and a circular arc shape.

In one embodiment, the wave shaped elements in the peripheral suture are each V-shaped, the wave shaped elements being composed of two sides having a common end point.

In one embodiment, the common endpoint is a point farthest from the waveform element, or the common endpoint is a point nearest to the waveform element.

In one embodiment, the angle formed between the two sides is in the range of 30 ° to 60 °.

In one embodiment, the peripheral suture comprises a plurality of medial line segments; the inner line sections are not parallel to the cross section of the fixed disc.

In one embodiment, the number of the wave-shaped units between two adjacent support bodies ranges from 4 to 6.

In one embodiment, the support body comprises a leading-out section formed by radiating from the connecting piece towards the far end, the leading-out section extends towards the near end through bending to form a hanging supporting section, one end of the hanging supporting section is connected with the leading-out section, and the other end of the hanging supporting section is a hanging end; the film body comprises a main body part and a plurality of extension parts, the main body part at least covers one part of each suspension supporting section, and the plurality of extension parts wrap the plurality of suspension end parts.

In one embodiment, the supporting body is provided with at least one fixing suture hole, and the thin film body is connected with the fixing disc through a fixing suture penetrating into the fixing suture hole.

In one embodiment, the fixation suture holes include a first suture hole, a second suture hole, and a third suture hole; the first suture hole is arranged on the leading-out section, and the second suture hole and the third suture hole are arranged on the suspended supporting section.

The invention also provides a sewing method, which is suitable for the occluder, the occluder comprises a fixed disk, the fixed disk comprises a connecting piece and a plurality of support bodies which are arranged at intervals in the circumferential direction, and the support bodies radiate outwards from the connecting piece and then extend towards the near end through bending; the fixed disk is provided with a film body, the film body at least partially covers two adjacent support bodies and a gap between the two adjacent support bodies, and the sewing method comprises the following steps:

set up a plurality of periphery suture holes on the film body to pass a plurality ofly with the periphery stylolite periphery suture hole, so that the periphery stylolite is in it is a plurality of to establish ties in the circumference of fixed disk periphery suture hole, wherein, a plurality of periphery suture hole is located on a plurality of cross sections of fixed disk, the periphery stylolite will a plurality of periphery suture holes establish ties, and on the arbitrary cross section of fixed disk the periphery stylolite all does not form closed figure.

In one embodiment, both ends of the peripheral suture line are tied inside the thin film body after the peripheral suture line passes through all the peripheral suture holes.

In the above technical solution, when the peripheral suture holes are located on the plurality of cross sections of the fixed disk, the peripheral suture threads passing through the plurality of peripheral suture holes one by one are also necessarily located on the plurality of cross sections of the fixed disk, and compared with the technical solution that the peripheral suture threads are all located on the same cross section, the length of the peripheral suture thread on a single cross section of the occluder of the present invention is shorter, so that in the process of taking in the loader, the size of the fixed disk after shrinking on the single cross section is smaller, and the number of released peripheral suture threads is less, so that the fixed disk can be taken in the loader (or sheath tube) more smoothly, and the possibility that the peripheral suture thread is torn off is reduced.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic structural view of a conventional occluding device in a natural deployment state;

figure 2 is a schematic view of the stopper of figure 1 partially received in a carrier;

figure 3 is a schematic illustration of the irregular folding of the membrane body of figure 1 with the occluding device partially stowed in the carrier;

FIG. 4 is a schematic structural diagram of an occluding device provided by one embodiment of the invention;

FIG. 5 is a schematic structural diagram of a fixing tray provided in an embodiment of the present invention;

FIG. 6 is a schematic view of the position of the anchor receptor according to one embodiment of the present invention;

FIG. 7 is a schematic structural diagram of a thin film body according to an embodiment of the present invention;

figure 8 is a schematic view of an occluder according to another embodiment of the present invention;

FIG. 9 is a schematic view of the peripheral suture between two supports when the occluding device provided by one embodiment of the invention is in a natural expanding state;

FIG. 10 is a schematic diagram of a waveform unit according to an embodiment of the present invention;

FIG. 11 is a schematic view of the peripheral suture between two support bodies in a natural deployment state of the occluding device provided by another embodiment of the present invention;

FIG. 12 is a schematic view of the peripheral suture between two supports in a naturally deployed state of the occluding device according to still another embodiment of the present invention;

FIG. 13 is a block diagram of a waveform element provided in accordance with another embodiment of the present invention;

figure 14 is a schematic illustration of the regular folding of the membrane body with the occluder of figure 4 partially stowed in a carrier;

fig. 15 is a schematic view of a knotting pattern of a peripheral suture according to an embodiment of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

In the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to an operator is generally referred to as the "proximal end", the end farther from the operator is referred to as the "distal end", and the "proximal end" and the "distal end" of any component of the medical device are defined according to this principle. "axial" generally refers to the length of the medical device as it is being delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines both "axial" and "radial" directions for any component of the medical device in accordance with this principle. For sutures, "a" strip "refers to the entire suture without breaking, and a" line segment "refers to a portion of the entire suture.

Referring to fig. 4, the present embodiment provides a stopper 1, which includes a fixed disk 11 and a sealing disk 12. The distal end of the sealing disk 12 is connected to the holding disk 11. In some embodiments, the sealing disc 12 may be made of at least one wire (e.g. nitinol wire) with superelasticity and shape memory property or biocompatible polymer wire, and after being woven into a mesh tube, the two ends of the mesh tube are respectively fixed by closing up the sleeve, and then are heat-set into a flat shape or a disc shape, etc., which is not limited as long as it can seal the tissue opening after being implanted in the body. The sleeve at the proximal end of the sealing disc 12 not only captures the proximal end of the wire, but also allows for detachable connection to the distal end of a delivery device that delivers the occluding device. The sleeve at the distal end of the sealing disc 12 is used not only to constrict the distal end of the wire but also to connect with the proximal end of the fixed disc 11. In other embodiments, the sealing disc 12 may be made of at least one metal tube with superelastic and shape memory properties, such as a nitinol tube, which is laser cut and heat set into a flat or disc-like shape, but is not limited to a shape that will occlude a tissue opening after implantation in a body. The sealing disk 12 may also be formed of at least one metal rod having superelastic and shape memory properties, such as a disk, and is not limited in shape so long as it is capable of occluding a tissue opening after implantation in a body.

The fixed disk 11 comprises a connecting piece 40 and a plurality of supporting bodies 20 which are arranged at intervals in the circumferential direction, and the plurality of supporting bodies 20 radiate outwards from the connecting piece 40 and then extend towards the proximal end through bending; the fixing plate 11 is provided with a thin film body 10, the thin film body 10 at least partially covers two adjacent supporting bodies 20 and a gap between the two adjacent supporting bodies 20, and the thin film body 10 is provided with a peripheral suture line 30 and a plurality of peripheral suture holes 50 along the circumferential direction of the fixing plate 11. The plurality of peripheral suture holes 50 may be formed in the thin film body 10 in advance, or may be formed during routing of the peripheral suture 30. The plurality of peripheral suture holes 50 are positioned on a plurality of cross sections of the fixed disk 11, the peripheral suture lines 30 connect the plurality of peripheral suture holes 50 in series, and the peripheral suture lines 30 do not form a closed figure on any cross section of the fixed disk 11.

As shown in fig. 4 and 5, the support body 20 includes a leading-out section 210 formed by radiating from the connecting member 40 of the fixed disk 11 toward the distal end, the leading-out section 210 extends toward the sealing disk 12 through bending to form a hanging support section 220, one end of the hanging support section 220 is connected to the leading-out section 210, and the other end is a hanging end 221. In addition, the suspending support section 220 is provided with an anchor 230 extending towards the proximal end and gradually away from the suspending support section 220, i.e. an included angle greater than 0 exists between the length direction of the anchor 230 and the length direction of the suspending support section 220. As shown in fig. 6, in the present embodiment, the anchoring thorn 230 is formed by laser cutting a portion of the suspended support section 220, so that an anchoring thorn receiving portion 240 for receiving the anchoring thorn 230 in a transportation state is formed at a corresponding portion of the suspended support section 220. In this embodiment, the anchoring receipt portion 240 has a through hole structure. It is understood that in other embodiments, the anchoring receipt portion 240 may be a groove structure, and designed according to actual requirements. The plurality of lead-out sections 210 constitute the lead-out section 21, and the plurality of flying support sections 220 constitute the anchor section 22. In practice, a plurality of struts 20 may be cut from the end of a nitinol tube in a direction toward the other end, and then heat-set after each strut 20 is spread by a die. Wherein the uncut portion of the nitinol tube may be left as a connecting body 40 for connecting the sealing disc 12.

The support body 20 may also be made of at least one wire (e.g., a nickel titanium wire) having superelastic 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 each of the plurality of supports 20 is connected to a corresponding connecting body 40, the sealing disk 12 is connected to the connecting body 40, and the remaining portion is formed into an umbrella shape by heat setting, thereby obtaining a fixed disk 11 having a lead portion 21 and an anchor portion 22.

In other embodiments, the fixed disk 11 may be formed by cutting a horn-shaped or tubular elastic material and then heat-setting the cut material into an umbrella shape, thereby obtaining the fixed disk 11 having the lead portion 21 and the anchor portion 22. The connecting body 40 for connecting the sealing disc 12 is disposed at the end of the elastic material with the smaller outer diameter, the portion of the elastic material except the connecting body 40 is the supporting body 20, the supporting body 20 occupies most of the elastic material, and the suspended portion obtained by cutting is the suspended supporting section 220.

In other embodiments, the support body 20, which radiates in parallel from the connecting piece 40 and then curves outward and extends toward the sealing disk 12, can likewise form a plurality of spaced apart, overhanging bearing sections 220. The specific case of at least one support body 20 radiating out of the center is not to be mentioned here, as long as a plurality of spaced-apart, free bearing sections 220 can be formed after the extension towards the sealing plate 12.

In some embodiments, the thin film body 10 disposed on the fixed disk 11 may 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, the thin film body 10 covers the thin film body 10 along the circumferential direction of the fixed disk 11, two adjacent support bodies 20 are covered by the thin film body 10, and the gap between the two adjacent support bodies 20 is also covered by the thin film body 10.

In other embodiments, the film body 10 may also partially cover the two adjacent supports 20 and the gap between the two adjacent supports 20. For example, the film member 10 may be a ring-shaped film that covers only a part of the anchor portion 22, or a ring-shaped film that completely covers the anchor portion 22 but does not cover the lead portion 21.

The film body 10 may be made of Polyethylene terephthalate (PET), Polytetrafluoroethylene (PTFE), silica gel, or other materials with biocompatibility and physical properties meeting the requirements. The film body 10 can be fixed to the support body 20 by sewing. It is understood that, in other embodiments, the thin film body 10 can be fixed on the supporting body 20 by gluing or the like.

As shown in fig. 5 and 6, in some embodiments, the support body 20 is provided with at least one suture-fixing hole 23. The fixing suture holes 23 include a first suture hole 231, a second suture hole 232, and a third suture hole 233. The first suture hole 231 is provided at the lead-out section 210. A second suture hole 232 and a third suture hole 233 are provided in the overhead support section 220. The fixing suture may be respectively passed 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, and the single-point suture may be performed to each of the fixing suture holes 23 (i.e., the fixing suture is used to suture the film body 10 and the fixing plate 11 at one suture hole and then knotted, the suture is cut, and the suture is sewn at the next suture point), so as to be fixed to the leading-out section 210 and the flying support section 220 and cover the leading-out section 21 and the anchoring section 22, and also cover the flying end 221 of the anchoring section 22. Preferably, the anchoring receipt 240 of the anchoring portion 22 is located at the suspended support section 220, the second suture holes 232 and the third suture holes 233 are located at two ends of the anchoring receipt 240, and at this time, the second suture holes 232 and the third suture holes 233 are symmetrically arranged with respect to the anchoring receipt 240, so that the corresponding portions of the thin film body 10 are fixed at two ends of the anchoring receipt 240, thereby ensuring uniform stress at the connection position and improving the connection stability. It should be understood that the fixing suture line referred to in the present invention may be a continuous unbroken suture line or a broken suture line, but the sewing position of the suture line is not poor, for example, the thin film body 10 and the fixing disk 11 are all sewed with the suture line at the fixing suture hole 23.

Referring to fig. 7, the thin film body 10 includes a main body portion 310 and a plurality of extension portions 320, the main body portion 310 is substantially circular, the plurality of extension portions 320 are connected to an edge of the main body portion 310, and the plurality of extension portions 320 are circumferentially spaced along the main body portion 310. The outer edge of the thin film body 10 extends out of the extension parts 320, so that the thin film body 10 can be formed into a flower-like structure, and the number and the distribution positions of the extension parts 320 correspond to the number and the distribution positions of the suspended support sections 220. Referring to fig. 5 and 8, the main body 310 has a large area and covers at least a portion of each suspension section 220, and the plurality of extension portions 320 of the thin film body 10 cover the plurality of suspension end portions 221. After the thin film body 10 covers the suspending end 221 of the anchoring portion 22, the thin film body 10 can isolate the suspending end 221 from the inner wall of the heart, so that the stimulation of the suspending end 221, which is directly exposed after the occluder enters the left atrial appendage, to the inner wall of the heart is reduced. Moreover, after the hanging end 221 of the present embodiment is covered by the thin film 10, the stimulation to the tissue and blood can be reduced, and the overall size of the hanging end 221 can be increased, which is more favorable for partially recovering the occluder 1 and effectively adjusting the position when the occluder 1 is not ideally released. It should be understood that although the suspending end 221 of the occluder 1 of the present invention covers the thin film body 10 and then the suspending end 221 still catches the pectinate muscle of the heart when the fixing disk 11 is partially released, the overall size of the suspending end 221 is increased and the thin film body 10 is softer than the suspending end 221, which greatly reduces the difficulty of subsequent recovery and adjustment.

It should be noted that "coating" referred to in the present invention is that "the object B coats the object a" or "the object a is coated by the object B" when the surface of the object a is completely covered by the object B, and is not referred to in the present invention when the object B only covers a part of the surface of the object a.

Referring again to FIG. 4, in some embodiments, the peripheral seam 30 can be continuously routed on the membrane body 10 and at least one turn around the periphery of the fixing plate 11. In other embodiments, peripheral stitch 30 may only partially encircle the periphery of fixed disk 11. Herein, the present invention defines "continuous trace" as a suture passing through at least three continuous suture holes of the same suture (e.g. the thin film body 10) without interruption, i.e. the suture passing through the three continuous suture holes of the same suture body is the same continuous unbroken suture.

The plugging device 1 is implanted internal back, when suffering left auricle inner wall extrusion, because left auricle inner wall probably has "bulge" or "sunk part", leads to certain supporter 20 to probably take place great deformation to make this supporter 20 because of the power that deformation produced act on with the left auricle inner wall of this supporter 20 contact, probably cause the damage to left auricle inner wall, and then form the hydrops. And when the peripheral suture line 30 is complete to form a structure similar to a ring when encircling the periphery of the fixed disk 11 for one circle, the constraint on each supporting body 20 can be realized, and when a certain supporting body 20 deforms, the force can be dispersed to the adjacent supporting body 20 through the peripheral suture line 30, so that the possibility of damage to the inner wall of the left auricle is reduced, and the effusion risk is reduced. Of course, the more the number of the circumferential sewing thread 30 is wound around the circumference of the fixed disk 11, the stronger the binding force to the supporting body 20 is, but the excessive number of the winding turns not only increases the process complexity and the cost, but also may cause the size of the fixed disk 11 after being radially compressed to be too large, thereby increasing the difficulty of the fixed disk 11 in being taken into the loader 13 (or the sheath).

When the fixed disks 11 are in a naturally expanded state (the so-called naturally expanded state means a naturally stretched state without being subjected to an external human force), the peripheral sewing thread 30 is constrained in a predetermined shape by the plurality of peripheral sewing holes 50. The peripheral suture 30 may be positioned between the anchor 230 and the proximal edge of the thin film body 10 to facilitate providing a greater radial restraining force. Wherein, the peripheral suture 30 comprises a plurality of outer line segments (solid line segments, the same below in the figure) and a plurality of inner line segments (dotted line segments, the same below in the figure), the inner line segment is the line segment inside the thin film body 10 when the fixing disk 11 is in the natural expansion state; the outer line segment is the line segment exposed outside the thin film body 10 when the fixed disk 11 is in the natural unfolding state.

Referring to fig. 5 and 6, in some embodiments, the peripheral suture line 30 may pass through the anchor receiving portion 240 of the anchor portion 22, and the anchors 230 of the anchor portion 22 are located on the anchor portion 22, so that the thin film body 10 and the fixed disk 11 may be stably connected by the peripheral suture line 30, and the force applied to the connecting portion may be uniform. The peripheral suture 30 may be pressed under the anchor 230 when passing through the anchor receiving part 240, thereby providing a fixing effect to a corresponding portion of the peripheral suture 30 and improving stable connection to the film body 10.

In other embodiments, the peripheral seam 30 is wound around the inner surface of the supporting body 20 (i.e. the side of the supporting body 20 facing the central axis of the fixing plate 11 when the fixing plate 11 is in the naturally unfolded state) when being routed to the vicinity of one supporting body 20 on the thin film body 10, and then extends on the inner surface of the supporting body 20 and then returns to the thin film body 10 to be further routed so as to further fix the thin film body 10 and the supporting body 20 by the peripheral seam 30.

In other embodiments, the outer peripheral suture threads 30 may not pass through the anchor receiving portions 240 of the anchor portions 22, and the outer peripheral suture threads 30 may be positioned outside the support body 20 (i.e., on the side of the support body 20 facing away from the central axis of the fixed disk 11 when the fixed disk 11 is in the naturally expanded state).

In some embodiments, peripheral suture 30 is helical when fixation disk 11 is in a naturally expanded state.

In other embodiments, peripheral suture 30 includes at least one wave shaped element 31 when fixation disk 11 is in a naturally expanded state. The shape of the wave-shaped unit 31 may be one or more of a V shape, a platform shape, and a circular arc shape, and may be any other suitable shape. As shown in fig. 4, the waveform units 31 may be arranged in series, that is, adjacent waveform units 31 are directly connected to each other; the wave units 31 may be arranged at intervals, as shown in fig. 9, that is, adjacent wave 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.

Referring to fig. 9, in some embodiments, when the fixed plate 11 is in the natural-unfolding state, the peripheral suture line 30 surrounds the periphery of the fixed plate 11 for one circle, and the peripheral suture line 30 includes a plurality of platform-shaped wave units 31a arranged at intervals. Referring to fig. 10, the mesa-shaped waveform unit 31a includes three sides, wherein a first end of the first side 311 is connected to a first end of the second side 312, a joint of the first end of the first side 311 and the first end of the second side 312 forms a first common endpoint, a second end of the second side 312 is connected to a first end of the third side 313, a joint of 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, 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 wave unit 31a is located on the first cross section of the fixed disk 11, and the connecting line segment 32 between two adjacent wave 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 in the first cross section and the second cross section, the total length of the segments of the peripheral suture 30 in the first cross section and the total length of the segments of the peripheral suture 30 in the second cross section can be smaller than or equal to the inner perimeter of the loader port (the inner perimeter of the loader port and the inner perimeter of the sheath port used by the stopper 1 with the same specification) and at this time, the length of the peripheral suture 30 which can be released in the cross section is almost 0, so that the friction or the pulling of the loader port or the sheath port on the peripheral suture 30 can be reduced to a greater extent in the process of taking the fixing disk 11 into the loader 13 or the sheath, and the size of the fixing disk 11 in the radially compressed state on the first cross section and the second cross section can be smaller.

The length of the peripheral suture 30 that can be released on a certain cross section is calculated by the following method: when the total length of the outer peripheral suture 30 in the cross section is greater than or equal to the inner circumference length of the loading port, the difference between the total length of the outer peripheral suture 30 in the cross section and the loading port is the length of the releasable outer peripheral suture 30, and when the total length of the outer peripheral suture 30 in the cross section is less than the inner circumference length of the loading port, the length of the releasable outer peripheral suture 30 is 0.

When the fixed disk 11 is in the natural unfolding state, the line segments of the peripheral sewing lines 30 on the first cross section and the second cross section are positioned on the outer side of the fixed disk 11. In the process of taking the fixing disc 11 into the loader port or the sheath port, the proximal end of the suspended supporting section 220 of the supporting body 20 is turned towards the distal end, so that the thin film body 10 and the line segment of the peripheral suture line 30 on the first cross section and the second cross section are also turned towards the inner side of the fixing disc 11, and at the moment, the length of the line segment of the peripheral suture line 30 on the first cross section and the second cross section, which is in contact with the loader port or the sheath port, is reduced to the shortest (almost 0), and the probability of friction or pulling of the loader port or the sheath port on the peripheral suture line 30 is further reduced.

Referring to fig. 11, in some embodiments, when the fixed plate 11 is in the natural-unfolding state, the peripheral suture line 30 surrounds the periphery of the fixed plate 11 by one turn, and the peripheral suture line 30 includes a plurality of platform-shaped wave units 31a arranged in series. The second side 312 of each platform-shaped wave shaped unit 31a is located on the third cross section of the fixed disk 11. When the anchor plate 11 is in the naturally deployed state, the total length of the segments of the peripheral suture 30 in the third cross-section is less than or equal to the inner perimeter at the port of the cartridge, so that the length of the peripheral suture 30 releasable in the third cross-section is almost 0. In addition, the probability of rubbing or pulling of the peripheral suture 30 by the loader or sheath port can be further reduced by reducing the total length of the segments of the peripheral suture 30 on the third cross-section inside the fixed disk 11.

Referring to fig. 12, in some embodiments, when the fixed plate 11 is in the natural-unfolding state, the peripheral suture line 30 surrounds the periphery of the fixed plate 11 by one turn, and the peripheral suture line 30 includes a plurality of platform-shaped wave units 31a and V-shaped wave units 31b which are arranged in series. The second side 312 (refer to fig. 10) of each platform-shaped wave unit 31a is located on the third cross section of the fixed disk 11. By arranging the platform-shaped wave units 31a and the V-shaped wave units 31b in combination, the total length of the segments of the peripheral suture line 30 in the third cross section can be further reduced, compared to the platform-shaped wave units 31a arranged in series in fig. 3. Referring to fig. 13, the V-shaped wave element 31b is composed of two sides having a first common end, and an angle is formed between the two sides. The third common end point 314 is the farthest point of the V-shaped waveform element 31b, or the third common end point 314 is the nearest point of the V-shaped waveform element 31 b.

In other embodiments, all of the inner segments of peripheral suture 30 are not parallel to the cross-section of fixation disk 11, e.g., all of the inner segments of peripheral suture 30 are at an angle greater than or equal to 30 ° to the cross-section of fixation disk 11, thereby further reducing the length of the inner segments on a single cross-section of fixation disk 11.

Referring again to fig. 4, in some embodiments, peripheral stitching 30 surrounds the periphery of stationary plate 11 a circle, and peripheral stitching 30 includes a plurality of V-shaped wave units 31b arranged in series. In this embodiment, the wave-shaped units 31 of the peripheral suture line 30 are continuously arranged, so that the length of the peripheral suture line 30 on each cross section of the fixed disk 11 is greatly reduced, and the friction or the pull of the loader port or the sheath port to the peripheral suture line 30 can be reduced. And because the wave-shaped units 31 are all in a V shape, the peripheral suture lines 30 can play a role in guiding and restraining the thin film body 10 in the process of taking the fixed disc 11 into the loader 13 or the sheath. As shown in FIG. 14, the film body 10 can be folded along the V-shaped wave unit 31b to resemble a wave, wherein the wave crests or troughs are at the third common end 314 of the two sides of the V-shaped wave unit 31 b. Compared with the prior art that the thin film bodies 10 are stacked randomly at the port of the loader 13 (or the sheath) when the fixed disk 11 is received in the loader 13 (or the sheath) as shown in fig. 3, the technical solution of this embodiment can further reduce the size of the fixed disk 11 after shrinkage, so that the fixed disk 11 can be received in the loader 13 or the sheath more easily, and can also reduce the contact area between the thin film bodies 10 and the port of the loader or the port of the sheath, thereby reducing the probability of damage to the thin film bodies 10 caused by mutual friction between the thin film bodies 10 and the port of the loader or the port of the sheath.

It should be noted that, in this embodiment, if the V-shaped wave unit 31b between two adjacent supporting bodies 20 is too small, or the included angle (such as the angle ABC) between two edges of the V-shaped wave unit 31b is too large, the thin film body 10 cannot be folded along the V-shaped wave unit 31b into a wave shape during the process of taking the fixed tray 11 into the loader 13 or the sheath nozzle, or the effect of reducing the probability of breakage of the thin film body 10 is not obvious because the number of times of folding the thin film body 10 is too small; if too many V-shaped wave units 31b are formed between two adjacent support bodies 20, or if the angle between two sides of the V-shaped wave units 31b (such as angle ABC) is too small, the length of the peripheral suture 30 releasable in a partial cross-section will increase, increasing the friction or pulling of the loader or sheath nozzle on the peripheral suture 30 in the partial cross-section. Therefore, in the present embodiment, the angle range of the included angle between the two sides of the V-shaped wave unit 31b is 30 ° to 60 °, and the number of the V-shaped wave units 31b between two adjacent supporting bodies 20 is 4 to 6, and by reasonably setting the angle between the two sides of the V-shaped wave unit 31b and the number of the V-shaped wave units 31b, the probability that the film body 10 and the peripheral suture thread 30 rub or pull against the loader port or the sheath port can be reduced. Further, when the lengths of the two sides of the V-shaped wave unit 31b are equal, the film body 10 can be folded into a more regular wave shape by being restrained and guided by the peripheral sewing thread 30, so that the probability that the film body 10 and the loader port or the sheath port rub against each other and are pulled can be further reduced.

The invention also provides a sewing method, which comprises the following steps: the peripheral suture holes 50 are formed in the thin film body 10, and the peripheral suture 30 is inserted through the peripheral suture holes 50 such that the peripheral suture 30 is connected in series to the plurality of peripheral suture holes 50 in the circumferential direction of the fixed disk 11, wherein the plurality of peripheral suture holes 50 may be previously formed in the thin film body 10 or may be formed during routing of the peripheral suture 30. The plurality of peripheral suture holes 50 are positioned on a plurality of cross sections of the fixed disk 11, the peripheral suture lines 30 connect the plurality of peripheral suture holes 50 in series, and the peripheral suture lines 30 do not form a closed figure on any cross section of the fixed disk 11.

Taking the V-shaped waveform unit 31b shown in fig. 4 as an example, the stitching method may be specifically described as follows: one end of the peripheral sewing thread 30 is passed out of the thin film body 10 from the position a (where "pass out" refers to passing through the thin film body 10 from the inner side of the thin film body 10 to the outer side of the thin film body 10), and then passed into the thin film body 10 from the position B (where "pass in" refers to passing through the thin film body 10 from the outer side of the thin film body 10 to the inner side of the thin film body 10), and passed out from the position C, so as to form a V-shaped wave unit 31B; then, continuously penetrating from the position D and penetrating from the position E to form a second V-shaped waveform unit 31b, continuously routing, and forming a plurality of V-shaped waveform units 31b arranged continuously around the circumference of the fixed disk 11, wherein 5V-shaped waveform units 31b are arranged between two adjacent supporting bodies 20; finally, both ends of peripheral suture 30 are tightened and tied at position a, as shown in fig. 15. Wherein, the distance between the two points of the peripheral suture holes 50 and A, K formed at the positions of the thin film body 10 such as A-K and the like of the 'penetrating' or 'penetrating' is about 15 mm.

More specifically, after both ends of the peripheral suture thread 30 are gathered and tied, the excessive peripheral suture thread 30 is cut off, and the thread end of the peripheral suture thread 30 is ironed and melted to a distance of 0.5mm to 1.5mm from the tied position using a heat fusion tool (e.g., an electric iron, etc.). It should be noted that the knotted point formed by knotting is required to be on the inner side of the thin film body 10 rather than exposed to the outside, so as to avoid thrombus caused by the exposed knotted point.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. The occluder comprises a fixed disc, wherein the fixed disc comprises a connecting piece and a plurality of supporting bodies which are circumferentially arranged at intervals, and the supporting bodies radiate outwards from the connecting piece and then extend towards the near end through bending; be equipped with the film body on the fixed disk, the film body at least part covers two adjacent supporter and two adjacent clearance between the supporter, its characterized in that, the film body is gone up to follow the circumference of fixed disk is equipped with periphery suture and a plurality of periphery suture hole, and is a plurality of periphery suture hole is located on a plurality of cross sections of fixed disk, the periphery suture will be a plurality of the periphery suture hole is established ties, just is in on the arbitrary cross section of fixed disk the periphery suture all does not form closed figure.

2. The occlusion device of claim 1, wherein the peripheral sutures include at least one wave shaped element constrained by the plurality of peripheral suture holes when the fixation disc is in a naturally expanded state.

3. The occlusion device of claim 2, wherein the shape of the wave shaped unit comprises one or more of a V-shape, a plateau shape, and a circular arc shape.

4. The occlusion device of claim 2, wherein the waveform elements are each V-shaped, the waveform elements being comprised of two sides having common endpoints.

5. The occluder of claim 4, wherein said common end point is the most distal point of said waveform elements or said common end point is the most proximal point of said waveform elements.

6. The occluding device of claim 4, wherein the angle between the two sides is in the range of 30 ° to 60 °.

7. The occluder of any one of claims 1 to 6, wherein said peripheral suture comprises a plurality of inner side line segments; the inner line sections are not parallel to the cross section of the fixed disc.

8. The occluder of any one of claims 2 to 6, wherein the number of wave shaped elements between adjacent two of said supports is in the range of 4-6.

9. The occluder of any one of claims 1 to 6, wherein said support body comprises a leading section radiating from said connector towards a distal end, said leading section being bent to extend towards a proximal end to form a free end, one end of said free end being connected to said leading section and the other end being a free end; the film body comprises a main body part and a plurality of extension parts, the main body part at least covers one part of each suspension supporting section, and the plurality of extension parts wrap the plurality of suspension end parts.

10. The occlusion device of claim 9, wherein said support body is provided with at least one anchoring suture hole, said membrane body being connected to said anchoring disk by anchoring sutures threaded through said anchoring suture hole.

11. The occluder of claim 10, wherein said fixation suture holes comprise a first suture hole, a second suture hole and a third suture hole; the first suture hole is arranged on the leading-out section, and the second suture hole and the third suture hole are arranged on the suspended supporting section.

12. The suturing method is suitable for an occluder which comprises a fixed disc, wherein the fixed disc comprises a connecting piece and a plurality of supporting bodies which are arranged at intervals in the circumferential direction, and the supporting bodies radiate outwards from the connecting piece and then are bent and extend towards the near end; the fixed disk is provided with a film body, and the film body at least partially covers two adjacent support bodies and a gap between the two adjacent support bodies, and the sewing method is characterized by comprising the following steps:

set up the periphery seam hole on the film body to pass the periphery stylolite the periphery seam hole, so that the periphery stylolite is in it is a plurality of to establish ties in the circumference of fixed disk the periphery stylolite hole, wherein, a plurality of the periphery stylolite hole site in on a plurality of cross sections of fixed disk, the periphery stylolite will a plurality of periphery stylolite hole establish ties, and be in on the arbitrary cross section of fixed disk the periphery stylolite all does not form closed figure.

13. The suturing method of claim 12, wherein both ends of the peripheral suturing thread are tied inside the thin film body after the peripheral suturing thread passes through all of the peripheral suturing holes.