CN116269547B

CN116269547B - Plugging device and plugging system

Info

Publication number: CN116269547B
Application number: CN202310584059.9A
Authority: CN
Inventors: 程晓阳; 麻郑宇
Original assignee: Hangzhou Dinova EP Technology Co Ltd
Current assignee: Hangzhou Dinova EP Technology Co Ltd
Priority date: 2023-05-23
Filing date: 2023-05-23
Publication date: 2023-08-15
Anticipated expiration: 2043-05-23
Also published as: CN116269547A

Abstract

The application discloses a plugging device and a plugging system. The plugging device comprises a supporting frame for plugging a tissue gap, the supporting frame is formed by connecting a plurality of supporting rods, the plurality of supporting rods comprise first rods made of non-degradable materials, the first rods enclose a closed retaining area, and in a natural state, the retaining area can be used for a pipe body with the outer diameter being greater than or equal to 2mm to pass through. The plugging device provided by the application has the advantages of being flexible in use, high in practicability, low in safety risk and the like, based on the arrangement of the reserved area with larger aperture, so that the metal content in the plugging device is effectively reduced, the plugging device is beneficial to puncture operation.

Description

Plugging device and plugging system

Technical Field

The application relates to the technical field of medical instruments, in particular to a plugging device and a plugging system.

Background

The foramen ovale is a physiological channel of the embryo period of the interatrial septum, which is generally closed within 1 st year after birth, and about 20% -25% of the foramen ovale in the adult is incompletely closed, and patent foramen ovale (patent foramen ovale, PFO) is one of the most common congenital heart abnormalities in adults at present.

Elevated right atrial pressure (e.g., brief Valsalva events) in PFO patients may result in a right-to-left shunt. The right-to-left shunt allows thrombus formed in the venous system to bypass the pulmonary vessels from the venous system, directly into and block the cerebral arteries, resulting in abnormal embolism. The incidence of PFO in stroke patients of unknown cause is about 50%, the incidence of PFO in migraine patients is 30% -40%, and the incidence of PFO in migraine patients with aura is as high as 48% -70%.

For PFO treatment, traditional PFO treatment is surgical, however, surgical trauma is large, complications are prone to occur, and the cost is high. At present, a minimally invasive interventional technology is mainly adopted in a PFO treatment mode. Minimally invasive interventional procedures are performed under image guidance, and the occlusion device is implanted into the patient with minimal trauma (no skin incision, only with a puncture needle eye) to promote endothelialization of surrounding tissue at the surface of the occlusion device, thereby effecting occlusion of the defect.

However, the occluder in the related art is configured as a dense mesh braided structure, after the occluder is implanted into the foramen ovale of a patient, the position of the interatrial septum fossa is covered by the occluder, if a left atrial appendage occlusion, mitral valve repair, pulse ablation and other treatment operations are needed to be performed subsequently, puncture is difficult to be performed in the fossa ovalis, and then a conveying channel cannot be constructed, and the occluder of the dense mesh braided structure causes great difficulty for subsequent puncture treatment, is inflexible to use and has low practicability.

Disclosure of Invention

In view of the foregoing, embodiments of the present application provide an occlusion device and an occlusion system, so as to solve the problem that the existing occlusion device is not beneficial to the subsequent puncture treatment.

In a first aspect, an embodiment of the present application provides an occlusion device, where the occlusion device includes a support frame for occluding a tissue gap, where the support frame is formed by connecting a plurality of support rods, where the plurality of support rods includes a first rod made of a non-degradable material, and where the first rod encloses a closed retaining area, and in a natural state, the retaining area is capable of allowing a tube body with an outer diameter greater than or equal to 2mm to pass through.

In a second aspect, embodiments of the present application provide an occlusion system comprising a delivery device for delivering the occlusion device to the tissue opening, and an occlusion device as described above.

According to the plugging device and the plugging system provided by the embodiment of the application, the first rod made of the non-degradable material is surrounded into the closed reserved area, and the reserved area can be used for a pipe body with the outer diameter of more than or equal to 2mm to pass through in a natural state. On the one hand, after the plugging device is implanted into the tissue gap, at least part of the puncture sheath pipe and the conveying sheath pipe can penetrate through the reserved area to puncture and establish a conveying channel; on the other hand, the plugging device is beneficial to realizing a large mesh structure, and the metal content in the plugging device is reduced, so that the plugging device provided by the embodiment of the application has the advantages of flexible use, high practicability, low safety risk and the like.

Drawings

In order to more clearly illustrate the embodiments of the application or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, it being obvious that the drawings in the description below are only some embodiments of the application, and that other drawings can be obtained according to these drawings without inventive faculty for a person skilled in the art.

Fig. 1 is a projection view of an occlusion device according to a first embodiment of the present application formed on a projection plane.

Fig. 2 is a projection of the support ring of the occlusion device of fig. 1 onto a projection plane.

Fig. 3 is a schematic structural view of an occlusion device according to a second embodiment of the present application.

Fig. 4 is a projection view of the occluding device of fig. 3 formed on a projection plane.

Fig. 5 is a projection view of an occlusion device according to a third embodiment of the present application formed on a projection plane.

Fig. 6 is a projection view of an occluding device formed on a projection plane as provided by a fourth embodiment of the present application.

Fig. 7 is a projection view of an occluding device formed on a projection plane as provided by a fifth embodiment of the present application.

Fig. 8 is a projection view of an occluding device formed on a projection plane as provided by a sixth embodiment of the present application.

Fig. 9 is a projection view of an occlusion device according to a seventh embodiment of the present application formed on a projection plane.

Fig. 10 is a projection view of an occlusion device according to an eighth embodiment of the present application formed on a projection plane.

Fig. 11 is a projection view of an occlusion device according to a ninth embodiment of the present application formed on a projection plane.

The main reference numerals illustrate: the occlusion device 100; the occlusion device 100A; the occlusion device 100B; the occlusion device 100C; the occlusion device 100D; the occlusion device 100E; the occlusion device 100F; the occlusion device 100G; the occlusion device 100H; a support frame 110; a support bar 120; a constriction 130; a coating 150; a first lever 10; a reserved area 101; a puncture region 1011; a non-reserved area 102; a first fan-shaped region 105; arcuate edge 1051; a straight edge 1052; a second scalloped region 106; a third sector area 107; an axis A; a projection plane P1; a first central angle α; a second central angle beta; a third central angle gamma; an included angle delta; a radial direction X; a circumferential direction Y; a first sub-lever 11; a second sub-rod 12; a support ring 13; an intersection point 16; a separation point 161; a contact point 162; a second lever 20; a circumferential section 50; a first sub-circumferential segment 502; a second sub-circumferential segment 503; an end 505; a peak 51; a protrusion 511; a recess 513; a first peak 52; a second peak 53; trough 54; radial segment 60.

The application will be further described in the following detailed description in conjunction with the above-described figures.

Detailed Description

The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

It is to be understood that the terminology used in the description and claims of the application and in the above description and drawings is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The terms first, second and the like in the description and in the claims and in the above-described figures, are used for distinguishing between different objects and not necessarily for describing a sequential or chronological order. The singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term "comprising" and any variations thereof is intended to cover a non-exclusive inclusion. Furthermore, the present application may be embodied in many different forms and is not limited to the embodiments described in the present embodiment. The following specific examples are provided to facilitate a more thorough understanding of the present disclosure, in which terms indicating orientations of the components, up, down, left, right, etc., are merely for the locations of the illustrated structures in the corresponding drawings. In the description of the present application, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "disposed on … …" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; may be a mechanical connection; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present application will be understood in specific cases by those of ordinary skill in the art.

The description is then made of the preferred embodiments for carrying out the application, however, the foregoing description is for the purpose of illustrating the general principles of the application and is not meant to limit the scope of the application. The scope of the application is defined by the appended claims.

Referring to fig. 1 and fig. 2 together, fig. 1 is a projection view of a plugging device 100 according to a first embodiment of the present application formed on a projection plane; fig. 2 is a projection view of the support ring 13 of the occlusion device 100 of fig. 1 formed in a projection plane. The present application provides an occlusion device 100 comprising a scaffold 110 for occluding a tissue gap. The supporting frame 110 is formed by interconnecting a plurality of supporting bars 120. The plurality of support rods 120 includes a first rod 10 made of a non-degradable material. The first rod 10 encloses a closed retaining area 101. In the natural state, the reserved area 101 can be penetrated by a pipe body with the outer diameter of more than or equal to 2 mm.

According to the plugging device 100 provided by the application, based on the fact that the first rod 10 made of the non-degradable material is enclosed into the closed reserved area 101, the reserved area 101 can be penetrated by a pipe body with the outer diameter being more than or equal to 2mm in a natural state, on one hand, after the plugging device is implanted into a tissue gap, at least part of a puncture sheath pipe and a conveying sheath pipe can penetrate through the reserved area 101 to puncture and establish a conveying channel; on the other hand, the plugging device 100 is beneficial to realizing a large mesh structure and reducing the metal content in the plugging device, so that the plugging device 100 provided by the embodiment of the application has the advantages of flexible use, high practicability, low safety risk and the like.

Tissue indentations for occlusion by occlusion device 100 include, but are not limited to, atrial septal defects (atrial septal defect, ASD), ventricular septal defects (ventricular septal defect, VSD), patent foramen ovale, patent ductus arteriosus (patent ductus arteriosus, PDA). It will be appreciated that in some embodiments the defect may also be another defect, for example the occlusion device 100 is also used for implantation into a blood vessel, such as for treatment of an aortic aneurysm. In the embodiments of the present application described with reference to the use of the occluding device 100 for occluding patent foramen ovale, it will be appreciated that the occluding device 100 may also be used to occlude other openings as noted above or other openings not noted.

The "natural state" in the present application refers to a state in which the occlusion device 100 is completely released, that is, a state in which the occlusion device 100 is completely inflated. In other words, the "natural state" refers to a fully expanded state in which the occluding device 100 is not subjected to the delivery device or the forces exerted thereon by the living tissue. For convenience in describing the structure of the occluding device 100, the present application is primarily limited by the structure and parameters of the elements of the occluding device 100 in its natural state, and is not limited thereto, i.e., the occluding device 100 of the present application may also have a compressed state or other states, where the occluding device 100 is retracted within a delivery sheath in a delivery vessel.

The tube may be a puncture sheath, a delivery sheath, or other tubular structure for treating a living being through the retention zone 101. The shape of the cross section of the pipe body along the radial direction of the pipe body is circular. The outer diameter of the tube body refers to the diameter of the outer circle of the tube body. In some embodiments, the outer periphery of the cross section of the pipe body along the radial direction of the pipe body may also be elliptical or other irregular annular, and then the outer diameter of the pipe body refers to the maximum outer periphery of the pipe body along the radial direction of the pipe body, and the shape of the cross section of the pipe body along the radial direction of the pipe body may be designed according to practical situations, and the application is not limited specifically.

Referring to fig. 1 to 3, fig. 3 is a schematic structural diagram of a plugging device 100A according to a second embodiment of the present application. The term "axial direction" as used in the embodiments and claims herein refers to the direction of the axis a of the support bracket 110, i.e., along the central axis of the support bracket 110; the term "radial direction X" refers to a direction perpendicular to the axis a of the support frame 110, i.e., along the radial direction of the support frame 110; the term "circumferential direction Y" refers to the circumferential direction of the support bracket 110, i.e., the direction about the axis a of the support bracket 110. The axial direction, the radial direction X, and the circumferential direction Y together form three orthogonal directions of the support frame 110. Axis a of the support frame 110 refers to an axis of the support frame 110 extending between the proximal and distal ends of the support frame 110 through the geometric center of the support frame 110.

The first rod 10 in the present application is made of a non-degradable material, which is a material that cannot be degraded, decomposed, eroded, metabolized after being implanted into a human body. In the present embodiment, the non-degradable material includes, but is not limited to, at least one of a non-degradable metallic material and a non-degradable polymer material. The non-degradable metallic material includes, but is not limited to, at least one of stainless steel, tungsten alloy, cobalt-based alloy, and nickel-titanium alloy. The first rod 10 is made of a material with good biocompatibility, so that local tissue hardening caused by implantation of the plugging device 100 is avoided, stimulation of the plugging device 100 to a human body is reduced, and further long-term complication rate of long-term retention of the plugging device 100 can be reduced.

The supporting frame 110 is formed by interconnecting a plurality of supporting rods 120, and forms a net structure. In this embodiment, the occluding device comprises a support stent 110, such as a single-disc structure, to occlude the tissue site with the single-disc structure. In some embodiments, the occlusion device comprises two support frames 110, i.e. forming a double disc structure, the two support frames 110 being used for occluding a side surface of the tissue indentation, respectively.

In the present embodiment, the support frame 110 is configured as a single-layer net-disc structure, and it is understood that the support frame 110 may also be configured as a double-layer net-disc structure, such as a plug, i.e. the double-layer net-disc structure formed by the support frame 110 encloses an inner cavity. The structure of the support frame 110 may be specifically selected according to practical needs, and the present application is not particularly limited.

In some embodiments, the occluding device 100 further comprises a cover film 150. The cover 150 is disposed on the support frame 110. The support frame 110 is used for carrying the covering film 150. The coating 150 may have desired functions of blocking flow, developing, maintaining structural stability of the support stand 110, and the like. The covering film 150 may be formed on the support frame 110 by, but not limited to, sewing, bonding, hot pressing, electrostatic spinning, dipping, coating, etc., so as to form a single-layer sealing disc or a double-layer sealing disc, i.e., the sealing device 100 includes the support frame 110 and the covering film 150 covering the support frame 110. The cover 150 covers at least one side of the support frame 110. In some embodiments, the covering film 150 and the supporting frame 110 are integrally formed, i.e. they are seamlessly connected or integrally formed, which is beneficial for the adhesion of the whole sealing disc and tissue of the sealing device 100, and the endothelialization effect of the cells is better and the endothelialization speed is faster.

The material of the covering film 150 may be a degradable material or a non-degradable material. In this embodiment, the material of the covering film 150 includes a degradable material, so that the smoothness of the puncture of the reserved area 101 can be improved after the covering film 150 is degraded in the human body. Optionally, in some embodiments, the covering film 150 is made of a degradable material at a position corresponding to the reserved area 101, so as to achieve both smoothness of puncture and endothelialization effect of the tissue gap. In some embodiments, the cover film 150 is entirely made of a degradable material, which is advantageous in improving the biocompatibility of the occlusion device 100, and the cover film 150 is gradually degraded after a certain period of use and finally becomes water and carbon dioxide which are easily absorbed and metabolized by the human body, thereby being advantageous in reducing the irritation to the human body and further being capable of reducing the long-term complications rate of the occlusion device 100 being left for a long time. Degradable materials include, but are not limited to, at least one of Polylactic acid (PLA), polycaprolactone (PCL), polyglycolide (PGA), polybutylene succinate (Poly butylene succinate, PBS), 1, 3-Propanediol (PDO), and poly (L-lactide-co-epsilon-caprolactone) series copolymers.

In some embodiments, the material of the cover film 150 includes a non-degradable material. Non-degradable materials include, but are not limited to, at least one of Polyurethane (PU), thermoplastic Polyurethane elastomer rubber (Thermoplastic polyurethanes, TPU), expanded polytetrafluoroethylene (Expanded Poly tetra fluoroethylene, ePTFE), polyethylene terephthalate (Polyethylene terephthalate, PET), polytetrafluoroethylene (Poly tetra fluoroethylene, PTFE), silicone rubber, hydrogels, polyvinyl alcohol (Polyvinyl alcohol, PVA), polyethylene (Polyethene, PE), high density polyethylene (High density polyethylene, HDPE), polyethylene terephthalate (Polyethylene glycol terephthalate, PET). When the covering film 150 is made of a non-degradable material, the puncture sheath can puncture the covering film 150, thereby ensuring that the puncture is performed smoothly.

The shape of the retention area 101 includes, but is not limited to, a circular ring shape, a semicircular shape, an elliptical shape, a drop shape, a petal shape, etc., a regular or irregular closed ring shape. In the present embodiment, the shape of the reserve area 101 is a drop shape. Specifically, in the present embodiment, the support frame 110 includes a plurality of support bars 120. The plurality of support bars 120 are each configured as the first bar 10. Each first rod 10 is wound to form a closed support ring 13. The area enclosed by each support ring 13 is a reserved area 101. The three support rings 13 are sequentially arranged along the circumferential direction Y of the support frame 110, and are adjacent to each other two by two. Thus, on the one hand, the number of the supporting rings 13 is smaller, the coverage area is larger, the large-mesh design of the plugging device 100 is facilitated, the large-mesh design is beneficial to reducing the metal material consumption of the supporting frame 110, for example, the weight of the non-degradable supporting frame 110 in the plugging device 100 is reduced, so that the long-term permanent implantation risk of the supporting frame 110 made of the non-degradable material is reduced, and complications such as metal ion precipitation and allergy are reduced; on the other hand, the supporting rod 120 of the supporting frame 110 is made of a non-degradable metal material, which is favorable for the development of the plugging device 100 under Digital Subtraction Angiography (DSA), is convenient for doctors to operate under DSA images, and reduces the risk of misoperation; on the other hand, after the occlusion device 100 is completely endothelialized, a subsequent operation requiring atrial septum puncture, such as left atrial appendage occlusion, mitral valve repair, pulse ablation, etc., can be performed, so that the fossa ovalis can be punctured in the retention area 101, the diameter of a sheath commonly used in interventional operations is 12F-28F, and the retention area 101 can ensure that at least part of the sheath can pass through, so that a puncture channel and a delivery channel for post-treatment can be conveniently constructed in the retention area 101.

In some embodiments, a first rod 10 of the plurality of support rods 120 is wound to form the closed at least one support ring 13, and the remaining support rods 120 of the plurality of support rods 120 may be wound to form an open loop structure. The open loop structure can be in a semicircular shape, a rod shape and the like. In some embodiments, the plurality of support rings 13 formed by winding the plurality of first rods 10 are arranged along the radial direction X of the support frame 110. In some embodiments, a plurality of support rings 13 formed by winding the plurality of first rods 10 are disposed at intervals from each other. In other embodiments, the plurality of support rings 13 formed by winding the plurality of first rods 10 are disposed adjacent to or overlap each other.

The retention zone 101 can be capable of being traversed by a tubular body having an external diameter greater than or equal to 8mm and/or the retention zone 101 can be capable of being traversed by a tubular body having an external diameter less than or equal to 12 mm. Specifically, in some embodiments, the retention zone 101 is capable of being passed through by a tube having an outer diameter greater than or equal to 8mm, so that the area of the retention zone 101 is not too small, so that most types of sheath can pass through the retention zone 101. In other embodiments, the retaining area 101 can be passed through by a tube body with an outer diameter greater than or equal to 2mm and less than or equal to 12mm, that is, the retaining area 101 can be passed through by a sheath tube with an outer diameter of 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, etc., so as to ensure that the retaining area 101 can be passed through by more types of tube bodies, ensure the mechanical performance and the plugging effect of the plugging device 100, avoid the area of the retaining area 101 from being too large, and ensure the mechanical performance of the corresponding support ring 13 to be relatively stable. In other embodiments, the retaining region 101 can be passed through by a tube body having an outer diameter greater than or equal to 8mm and an outer diameter less than or equal to 12mm, so that the area of the retaining region 101 is not too large or too small, and the mechanical properties and the blocking effect of the blocking device 100 are ensured. The outer diameter of the tube body is merely for illustration, and the present application is not particularly limited.

As shown in fig. 1, in some embodiments, the support bracket 110 further includes a constriction 130. The converging member 130 is used for converging at least part of the supporting rod 120. The convergence member 130 is disposed at a convergence center of the support frame 110. In this embodiment, the constriction 130 is configured as a tubular structure, such as a steel sleeve with openings at both ends. At least a portion of the support rod 120 is fixedly coupled to the convergence member 130, such as to an outer peripheral surface and/or an inner peripheral surface of the convergence member 130. The end of the support bar 120 or a portion between the two ends may be fixed to the convergence 130. For example, in some embodiments, the ends of a portion of the support rods 120 are fixedly coupled to the outer and/or inner peripheral surfaces of the constriction 130, and the remaining portion of the support rods 120 may be coupled to the support rods 120 fixedly coupled to the constriction 130, thereby achieving a fixation of the support rods 120. In this embodiment, the converging member 130 is used for converging the ends of all the support rods 120, that is, the ends of all the support rods 120 are fixedly connected to the converging member 130, so that the stress of each support rod 120 is uniform, and the smoothness and reliability of the recovery and release of the support frame 110 are ensured. Alternatively, in some embodiments, the convergence 130 may also be a combination of multi-layer steel jackets. In other embodiments, the converging member 130 and the supporting frame 110 may be integrally formed. The material of the constriction 130 includes, but is not limited to, stainless steel, nitinol, or other biocompatible materials.

The occluding device 100 of the present application may be formed by braiding and/or cutting to form a stent 110 as shown in figure 1. The support frame 110 includes a plurality of support bars 120. The plurality of support rods 120 are formed by braiding of braided wires having a shape memory effect, and/or the plurality of support rods 120 are formed by cutting at least one of a rod-like structure, a tube-like structure, and a plate-like structure having a shape memory effect. Specifically, the plurality of support rods 120 include at least one of a braided rod and a cut rod.

The support rod 120 in the present application may be a braided rod or a cut rod. The support pole 120 may refer to a complete strand of knitting yarn, and one or more knitting yarns may be included in the strand of knitting yarn, wherein a plurality of knitting yarns are arranged in parallel, and a plurality of knitting yarns arranged in parallel may be knitted with each other. The support bar 120 may also be referred to as a cut length of a cut bar having two ends for connection to other support bars or constrictions, or one of the two ends being a free end.

The plurality of support rods 120 are connected with each other to form the support frame 110, and at least part of the support rods 120 are connected with each other and are connected together at the connection part in a braiding manner, so that a certain binding deformation effect is ensured between the plurality of support rods 120 which are connected with each other. In addition, the connection between the support rods 120 can be selected according to the need to obtain the expected binding force and flexibility. For example, when at least part of the support rods 120 are connected at the connection part by means of interpenetration in knitting, it is also ensured that the support rods 120 can move relatively at the connection part, that is, the binding effect between the support rods 120 connected by interpenetration is not too large, so that the deformation between the support rods 120 is more flexible, and the sheath retraction and rebound after release of the plugging device 100 are smoother.

Optionally, in some embodiments, all support rings 13 are connected at the interconnection by braiding. In some embodiments, at least a portion of the brace 120 may be attached at the connection by, but not limited to, welding, bonding, stitching, etc.

In a natural state, the reserved area 101 includes a puncture area 1011. The puncture region 1011 is a portion of the retention region 101, for example, the puncture region 1011 is a region of the retention region 101 through which a tube having the largest outer diameter can pass. If the tube is inserted into the retaining area 101, a perforation is formed on the film 150 after the film 150 is inserted into the tube, and the thicker the inserted tube is, the larger the corresponding perforation is, the size and shape of the perforation are, and the corresponding perforation corresponds to the outer diameter of the inserted tube. If a tube (the thickest tube) with the largest outer diameter that can be accommodated in the retaining area 101 is inserted, the size and shape of the through hole are formed, and the size and shape of the through hole formed in the film by the inserted area 1011 and the tube with the largest outer diameter are the same.

It should be noted that, for convenience in describing the structural features of the retaining region 101 and the puncture region 1011, a plane perpendicular to the axis a of the supporting frame 110 is defined as a projection plane P1. The projection of the puncture region 1011 on the projection plane P1 is circular. Illustratively, in this embodiment, the tube is circular in cross-section, with the largest outer diameter tube passing through the support bracket 110 in a direction parallel to the axis A of the support bracket 110.

In some embodiments, the first bars 10 enclosing the support ring 13 are formed on the same plane, i.e. the reserved area 101 is formed on the same plane. The puncture region 1011 is a circular region having the largest area on the plane of the retention region 101. In order to match the application of the instrument, the tube passing through the puncture area 1011 is defined as a tube having a circular radial cross section. In some embodiments, the first rod 10, which encloses the support ring 13, cannot be accommodated in one plane, i.e. the reserved area 101 is formed on a different plane, the puncture area 1011 being the area of the largest tube that can pass through in the reserved area 101.

As shown in fig. 3, the supporting frame 110 is substantially bowl-shaped, and an included angle between the contour surface of the supporting ring 13 and the projection plane P1 is denoted as δ, wherein δ is 0-45 °, so that the supporting ring 13 of the supporting frame 110 can be well attached to the peripheral tissue of the defect. Illustratively, in the present embodiment, the contour surface of the support ring 13 is defined as a blocking surface for blocking the tissue gap. The projection plane P1 is defined as a surface perpendicular to the axis a of the support frame 110, and the number of projection planes P1 is plural, and may be a series of planes arranged at different axial positions along the axis a. Specifically, in the present embodiment, the projection plane P1 is taken as an example of one of the planes, which is a surface perpendicular to the axis a of the support bracket 110 and tangential to the support bracket 110. Defining, an edge point of the periphery of the support frame 110 farthest from the projection plane P1 is defined as a distal point B, and an intersection point of the projection plane P1 and the axis a of the support frame 110 is defined as an origin O. The included angle between the connecting line of the far end point B and the origin point O and the projection plane P1 is delta. The included angle delta is, but not limited to, 0 °, 5 °, 15 °, 20 °, 25 °, 30 °, 35 °, 40 °, 45 °, and the like. It should be noted that the angle of the included angle δ is merely for illustration, and the present application is not limited thereto.

Referring to fig. 1 and 2 again, taking the beam converging member 130 as the center, the projection of the sector area with the smallest central angle surrounding the puncture area 1011 on the projection plane P1 is the first sector area 105, the central angle of the first sector area 105 is the first central angle α, and the first central angle α is 45 ° -150 °.

The projection of the puncture region 1011 on the projection plane P1 is the largest circular area of the projection of the reserve region 101 on the projection plane P1, and the edge of the puncture region 1011 is tangent to the first rod 10 enclosing the puncture region 1011. The constriction 130 is used as a center of a circle, a plurality of fan-shaped areas surrounding the puncture area 1011 are provided, the center angles of the fan-shaped areas are relatively larger in the plurality of fan-shaped areas surrounding the puncture area 1011, the center angles of the fan-shaped areas are relatively smaller, and a fan-shaped area with the smallest center angle is included in the plurality of fan-shaped areas surrounding the puncture area 1011, and the projection of the fan-shaped area on the projection plane P1 is the first fan-shaped area 105. As shown in fig. 1, the first fan-shaped region 105 includes an arc-shaped side 1051 and straight sides 1052 connected to both ends of the arc-shaped side 1051, respectively. Both straight sides 1052 of the first sector 105 are tangential to the penetration region 1011.

Optionally, in some embodiments, the first central angle α is 60 ° to 120 °. In this way, in the first aspect, the plugging device 100 has good mechanical strength, and the plugging device 100 has strong rebound performance after being implanted, can better maintain a predetermined shape, and can maintain better structural stability; in the second aspect, during the implantation process of the plugging device 100, a doctor can observe and clearly judge the deformation condition of the plugging device 100 under DSA images, so as to determine the success criterion of the implantation of the plugging device 100 more intuitively; in the third aspect, since the structure of the plugging device 100 is relatively more stable, the covering film 150 is conveniently and firmly arranged on the plugging device 100, the covering film 150 is not easy to separate from the supporting frame 110, the covering film 150 is beneficial to attaching the septum primum tissue, timely plugging is realized, and residual diversion is reduced. The first central angle α is, but not limited to, an angle of 60 °, 70 °, 80 °, 90 °, 100 °, 110 ° or 120 °. It should be noted that the angle of the first central angle α is merely for illustration, and the present application is not limited thereto.

The support bracket 110 includes a plurality of circumferential segments 50 and a plurality of radial segments 60. The plurality of circumferential segments 50 are disposed along the circumferential direction Y of the support bracket 110 and form the periphery of the support bracket 110. Illustratively, in the present embodiment, the periphery of the support frame 110 is rounded, thereby avoiding snagging of the support frame 110 against tissue. Specifically, a plurality of circumferential segments 50 are joined end-to-end and form a torus-like structure. All circumferential segments 50 are arranged along a circumferential direction Y of the support frame 110 and form a periphery of the support frame 110, each periphery Xiang Duan comprising two ends 505 opposite in the circumferential direction Y of the support frame 110, the radial segments 60 being connected between the corresponding ends 505 and the constriction 130. The plurality of radial segments 60 are disposed radially from the constriction 130 toward the periphery of the support frame 110, i.e., each radial segment 60 extends between the periphery of the support frame 110 and the constriction 130. One end of the radial segment 60 is connected to the end 505 of the corresponding circumferential segment 50 and the other end is connected to the constriction 130. The material of circumferential segment 50 and the material of radial segment 60 may be the same or different. The materials of the plurality of circumferential segments 50 may be the same or different. The material of the plurality of radial segments 60 may be the same or different. Illustratively, in the present embodiment, the material of the plurality of circumferential segments 50 and the material of the plurality of radial segments 60 are both the same and are made of a non-degradable metallic material.

As shown in fig. 2, the edge of the penetration zone 1011 is tangential to both the circumferential section 50 and both radial sections 60. Optionally, in some embodiments, the edge of the penetration region 1011 is tangential to at least one of the circumferential section 50 and the two radial sections 60.

In this embodiment, the first rod 10 is a strand of braided wire, and the first rod 10 may include one or more braided wires therein and enclose a support ring 13. Both ends of one first rod 10 are converged to the convergence member 130. In some embodiments, one first rod 10 cannot enclose one support ring 13, for example, a plurality of first rods 10 together enclose one support ring 13. In other embodiments, one first rod 10 can enclose a plurality of support rings 13.

Specifically, the support ring 13 includes one circumference Xiang Duan and two radial segments 60, and one end of each radial segment 60 is connected to the circumferential segment 50 and the other end of the radial segment 60 is connected to the converging member 130. A circumference Xiang Duan and the two radial segments 60 together enclose a closed retaining area 101. In this embodiment, two adjacent support rings 13 share a radial segment 60, on one hand, because the connection area between the plurality of support rings 13 is larger, the constraint between the support rings 13 in the plugging device 100 is stronger, which is beneficial to improving the deformation resistance of the plugging device 100, facilitating the attachment of the plugging device 100 on the room septum, and effectively reducing residual diversion; on the other hand, simplifying the processing, reducing the metal content in the occluding device 100, and making the shape of the reserved area 101 simple. In some embodiments, each support ring 13 adjacent has two independent radial segments 60, thereby improving the deformability of the occluding device 100 in the circumferential direction Y and facilitating the unsheathing and release.

In this embodiment, each perimeter Xiang Duan is a section of a strand of braided wire, and the perimeter of the support frame 110 is defined by a plurality of circumferential sections 50, i.e., a plurality of first bars 10 form the perimeter of the support frame 110. In some variations, the perimeter of the support frame 110 is defined by a first bar 10. Alternatively, the radial segments 60 may belong to a different support rod 120 than the circumferential segments 50. In some embodiments, the two radial segments 60 and the circumferential segment 50 of the same support ring 13 belong to the same support bar 120.

In this embodiment, the two radial segments 60 that enclose the retaining area 101 are each tangential to the straight edge 1052 of the first sector 105, and in a variant embodiment, the two radial segments 60 that enclose the retaining area 101 cannot be tangential to at least one straight edge 1052 of the first sector 105.

The plurality of circumferential segments 50 and the plurality of radial segments 60 are all configured as arcuate segments, which facilitate providing a large sealing area, and also ensure smoothness of instrument sheath retraction and release. In this embodiment, the plurality of radial segments 60 are arranged in a spiral. Optionally, in this embodiment, the structures of the radial segments 60 are the same, that is, the bending curvatures and arc lengths of the radial segments 60 are the same, so that the support frame 110 is ensured to be stressed uniformly along the circumferential direction, the deformation resistance is improved, and the plugging effect is better. In some embodiments, the structure of the plurality of radial segments 60 may also be designed differently, and the application is not particularly limited. The arc length of circumferential section 50 is greater than the arc length of radial section 60 to facilitate formation of a macro-mesh structure in the reserved area 101. In some embodiments, the radial segment 60 may also be configured as a straight segment.

As shown in fig. 1, in the present embodiment, the number of the first rods 10 is plural, and the plural first rods 10 include at least one first sub-rod 11, and the first sub-rod 11 is wound into a supporting ring 13. In said natural state, the closed area enclosed by the support ring 13 covers the reserved area 101. The support ring 13 around which the first sub-rod 11 is wound includes at least one intersection point 16 with other support rods 120.

In some embodiments, the first rod 10 further comprises at least one second sub-rod 12, and the other support rods 120 connected to the support ring 13 wound around the first sub-rod 11 are the second sub-rods 12, and the support ring 13 comprises at least one intersection point 16 connected to the second sub-rod 12. In other embodiments, the support frame further comprises a second rod made at least partially of degradable material, the other support rods 120 connected to the support ring 13 wound with the first sub-rod 11 being second rods, the support ring 13 comprising at least one intersection point 16 interconnecting the second rods.

Illustratively, in this embodiment, the first pole 10 comprises one first sub-pole 11 and two second sub-poles 12. The first sub-rod 11 is wound to form a support ring 13 and each second sub-rod 12 is also wound to form a support ring 13. The support ring 13 enclosed by the first sub-rod 11 and the support ring 13 enclosed by the second sub-rod 12 are adjacently arranged along the circumferential direction Y of the support frame 110, and two adjacent support rings 13 share one radial section 60. The intersection point 16 farthest from the converging member 130 among all the intersection points 16 on the first sub-rod 11 is defined as a separation point 161.

The projection of the maximum dimension between any point on the support ring 13 and the converging element 130 on the projection plane P1 along the radial direction X of the support frame 110 is a first dimension N, which can be considered as the projection of the radius of the support ring 13 on the projection plane P1. The first sub-rod 11 and the adjacent second sub-rod 12 are respectively formed with a separation point 161 at two sides in the circumferential direction Y, the distances between the two separation points 161 and the converging member 130 are equal, and the projections of the distances between the two separation points 161 and the converging member 130 on the projection plane P1 are the same as the second dimension M, wherein M/n=1. Because the separation points 161 are consistent with the circumferential radial dimension of the support frame 110, the circumferential section 50 tends to be more uniformly stressed, so that the plugging device 100 is not easy to deform after implantation, so that the plugging device can be firmly fixed on the atrial septum, the plugging effect is improved, a large mesh structure is formed at the reserved area 101, and the establishment of a puncture channel is facilitated.

It can be appreciated that, the larger the ratio of M/N, the larger the radial dimension of the separation point 161 between the support ring 13 surrounded by the first sub-rod 11 and the circumferentially adjacent second sub-rod 12 in the radial direction X of the support frame 110, the larger the plugging area of the support frame 110, so as to more limit the plugging of the oval foramen, and more effectively block the residual split flow. However, the greater the ratio of M/N, the more the circumferential section 50 of the strut 120 at the periphery of the strut 110 tends to be circular, the more the circumferential section 50 tends to be substantially uniform in radian (curvature), and the more difficult the sheath is to be retracted, in which the circumferential section 50 tends to be stress-uniform throughout the process of compressing the outer diameter of the strut 110. In some embodiments, the present application satisfies the relationship by designing the first dimension N and the second dimension M: on the one hand, the retaining area 101 can be ensured to form a larger mesh structure so as to puncture a tube body with larger outer diameter, wherein M/N is more than 0.5 and less than 0.9; on the other hand, the support frame 110 has larger plugging area and better plugging effect, and can provide better sheath retraction force to avoid overlarge sheath retraction force.

Alternatively, in other embodiments, the first dimension N and the second dimension M satisfy the relationship: 0.7 < M/N < 0.9, thereby enabling the occluding device 100 to have a relatively large reserved area 101, and enabling the occluding device 100 of the same specification to have a larger puncture space; further, the radial dimension of the separation point 161 is close to the radius of the support ring 13, the stress of the circumferential section 50 tends to be more uniform, and the circumferential section 50 is relatively not easy to deform after the tissue notch is released, so that the plugging device 100 can be firmly fixed on the atrial septum, the clamping force can be applied to the tissue more uniformly by the circumferential section 50, the stimulation to the tissue is reduced, and the plugging device 100 is more soft and comfortable. The ratio of M/N may be, but is not limited to, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, or 0.85, etc. It should be noted that the ratio of M/N is merely for illustration, and the present application is not particularly limited.

Illustratively, in the present embodiment, the projection of the distance between the separation point 161 and the beamer 130 on the projection plane P1 refers to the distance between the projection point of the separation point 161 on the projection plane P1 and the projection point of the geometric center point of the beamer 130 on the projection plane P1. In some embodiments, the projection of the distance between the separation point 161 and the beam-converging element 130 on the projection plane P1 refers to the distance between the projection point of the separation point 161 on the projection plane P1 and the projection point of the outer peripheral surface of the beam-converging element 130 on the projection plane P1, and the present application is not limited in particular. The term "intersection point" refers to a point on the corresponding support ring 13 that is in contact with and connected to the other support rods 120.

Optionally, in this embodiment, the occluding device 100 comprises three support rings 13 and the three support rings 13 are configured as non-degradable metal support rings. In some embodiments, some of the three support rings 13 are configured as non-degradable metal support rings and the remaining support rings 13 are configured as degradable metal support rings or degradable non-metal support rings.

In this embodiment, the first rod 10 comprises a metal rod made of a metal material, which is arranged outside the reserved area 101, so that the metal rod arranged in the reserved area 101 is prevented from blocking the penetration of the puncture sheath, and the subsequent treatment is affected.

Specifically, in the present embodiment, in the circumferential direction Y of the support frame 110, the support frame 110 does not have the first rod 10 in the reserved area 101, so that the support frame 110 is ensured to have a large mesh structure to facilitate establishment of a puncture passage through which a tube body passes.

In some embodiments, the first rod 10 comprises a flexible rod made of a polymeric non-degradable material, which may be disposed within the retention zone 101 and/or outside the retention zone 101. It will be appreciated that when the flexible rod is disposed in the retaining region 101, the polymer material is a softer biocompatible material, so that the puncture sheath can smoothly pass through the retaining region 101.

In some embodiments, at least one second rod is connected to the first rod 10. Optionally, the second rod disposed within the retention zone 101 is made of a degradable material. In this way, on the one hand, the blocking effect of the blocking device 100 is enhanced and, on the other hand, it is ensured that the second rod located in the retention area 101 can be degraded, eroded and metabolized by the human body, so as to ensure that the penetrating cannula can pass smoothly through the retention area 101.

The degradable material in the application refers to a material which can be gradually degraded, eroded and metabolized by a human body after being implanted into the human body. Degradable materials include, but are not limited to, degradable metallic materials and degradable polymeric materials. The degradable metallic material includes, but is not limited to, at least one of magnesium alloy, iron alloy or zinc alloy. The degradable polymer material includes, but is not limited to, one or a mixture of at least two of polylactic acid (PLA), polycaprolactone (PCL), polyglycolide (PGA), polydioxanone (p-dioxanone), PPDO), polygluconic acid (polygluconate), polyhydroxybutyric acid (polyhydroxybu tyrate), dry polyacid (polyanhydride), polyphosphoester (polyphosphoester).

In some embodiments, the second rod is at least partially made of a degradable material, at least one second rod being connected to the first rod 10. For example, the portion of the second rod located inside the reserve area 101 is made of a degradable material, and the portion of the second rod located outside the reserve area 101 is made of a non-degradable material, so that the second rod of the supporting frame 110 can be ensured to be formed with a large mesh structure after being degraded, eroded, metabolized. The second rod connected to the first rod 10 may be located inside the reserved area 101 and/or outside the reserved area 101. Alternatively, the second rod located within the retention zone 101 may be made of a degradable material and/or the second rod located outside the retention zone 101 may be made of a non-degradable material.

In some embodiments, the support bar includes at least a first sub-bar 11, the first sub-bar 11 being wound into a support ring 13. In the natural state, the closed area enclosed by the support ring 13 covers the reserved area 101. The projection of the sector with the smallest central angle surrounding the support ring 13 on the projection plane P1 with the beam converging member 130 as the center is the second sector 106, the central angle of the second sector 106 is the central angle β, and the second central angle β is 45 ° -160 °, so as to ensure that the support frame 110 forms a large mesh for the position of the reserved area 101, so as to establish a puncture channel for the tube body to pass through. The second central angle β is, but not limited to, an angle of 45 °, 55 °, 65 °, 75 °, 85 °, 95 °, 105 °, 110 °, 120 °, 130 °, 140 °, 150 °, 160 °, etc. It should be noted that the angle of the second central angle β is merely for illustration, and the present application is not limited thereto.

It should be noted that, with the beam converging member 130 as the center, there are a plurality of sector areas surrounding the supporting ring 13, among the plurality of sector areas surrounding the supporting ring 13, there are sector areas having smaller central angles and sector areas having larger central angles, among the plurality of sector areas surrounding the supporting ring 13, there is a sector area having the smallest central angle, and the projection of the sector area on the projection plane P1 is the second sector area 106.

Specifically, the first rod 10 is wound into a closed loop of support ring 13. The projection of the support ring 13 onto the projection plane P1 is located in the second sector 106. The reserved area 101 is the area surrounded by the support ring 13. The sector area surrounding the reserved area 101 having the smallest central angle corresponds to the second sector area 106. Since the puncture region 1011 is located in the retaining region 101, in the circumferential direction Y of the support frame 110, the coverage area of the retaining region 101 is equal to or larger than the coverage area of the puncture region 1011, and further the second central angle β of the second fan-shaped region 106 is equal to or larger than the first central angle α of the first fan-shaped region 105, and the second fan-shaped region 106 covers the first fan-shaped region 105.

In the present embodiment, each first rod 10 is wound into a closed loop of support rings 13, and the three support rings 13 are sequentially arranged along the circumferential direction Y of the support frame 110. The two adjacent support rings 13 are adjacently arranged, so that the support frame 110 has good mechanical strength and rebound resilience, the support frame 110 is convenient to release and recover, the plugging device 100 can better keep a preset shape after being implanted, better structural stability can be kept, and meanwhile, the space utilization rate of the circumferential direction Y of the support ring 13 is fully utilized, so that the support ring 13 is beneficial to forming a large-mesh structure.

The support frame 110 forms a plurality of retention areas 101, and the plurality of retention areas 101 are arranged in such a manner as to be adjacent to, spaced apart from, and/or overlap with each other in the circumferential direction Y of the support frame 110. Alternatively, the plurality of retaining areas 101 are arranged uniformly in the circumferential direction Y of the support frame 110. In this embodiment, the support frame 110 includes three first rods 10, each first rod 10 encloses a support ring 13, and a retaining area 101 is correspondingly formed, that is, 3 retaining areas 101,3 retaining areas 101 are formed and adjacently arranged in the circumferential direction Y of the support frame 110. It should be noted that, the number of the reserved areas 101 may be 3-8, which is convenient for realizing the macro-mesh structure of the support frame 110 to reduce the metal content of the support frame 110; on the other hand, the number of the reserved areas 101 is increased to increase the puncture sites and improve the puncture efficiency. In some embodiments, the occluding device 100 comprises one, two or more than three support rings 13, i.e. has one, two or more than three reserved areas 101. It should be noted that the number of the reserved areas 101 is merely for illustration, and the number of the reserved areas 101 may be designed according to practical situations, and the present application is not particularly limited.

Referring to fig. 3 and 4 together, fig. 4 is a projection view of the occlusion device 100A of fig. 3 formed on a projection plane. As shown in fig. 3, the occluding device 100A includes a stent 110 and a cover 150. The main difference between the occlusion device 100A provided in the second embodiment and the occlusion device 100 provided in the first embodiment is that in the second embodiment the first rod 10 is wound to form a support ring 13 having a different structure and arrangement than in the first embodiment.

The first lever 10 comprises a first sub-lever 11. The first sub-rod 11 is wound into a support ring 13. In the natural state, the closed area enclosed by the support ring 13 covers the reserved area 101. The number of the first sub-bars 11 may include one or more, and the present application is not particularly limited. The plurality of support rings 13 around which the first sub-rod 11 is wound are disposed at intervals or adjacently along the circumferential direction Y of the support frame 110.

In some embodiments, the first pole 10 further comprises at least one second sub-pole 12 connected to the first sub-pole 11. The converging member 130 is used for converging the first sub-rod 11 and the second sub-rod 12. At least part of the second sub-rod 12 is located within the support ring 13. In the natural state, the second sub-rod 12 divides the support ring 13 into at least one reserved area 101 and at least one unreserved area 102. The projection of the sector area with the smallest central angle surrounding any one unreserved area 102 on the projection plane P1 is a third sector area 107 by taking the beam converging piece 130 as a circle center, the central angle of the third sector area 107 is a third central angle, the third central angle is marked as gamma, and the second central angle is marked as beta, wherein, the gamma/beta is more than 0 and less than or equal to 0.6.

The plurality of sector areas surrounding any one of the unreserved regions 102 with the beam converging member 130 as the center of the circle, the plurality of sector areas surrounding any one of the unreserved regions 102, the plurality of sector areas having a larger central angle and the plurality of sector areas having a smaller central angle, include a sector area having a smallest central angle, and the projection of the sector area on the projection plane is the third sector area 107.

The first sub-rod 11 may be a braided rod and/or a cut rod; the second sub-rod 12 may also be a braided rod and/or a cut rod. The second sub-rod 12 includes one or more. In some embodiments, at least a portion of the second sub-rod 12 is wound to form a support ring 13. The support ring 13 around which the second sub-rod 12 is wound is disposed overlapping the support ring 13 around which the first sub-rod 11 is wound in the circumferential direction Y of the support bracket 110. In some embodiments, at least a portion of the second sub-rod 12 cannot be wound to form a support ring, e.g., the second sub-rod 12 is configured as a radial segment 60 within the support ring 13 around which the first sub-rod 11 is wound. Optionally, all the second sub-rods 12 located within the support ring 13 are arranged at intervals or adjacently along the circumferential direction Y of the support frame 110.

Illustratively, in the present embodiment, the first pole 10 includes three first sub-poles 11 and three second sub-poles 12. Each first sub-rod 11 and each second sub-rod 12 are wound into a supporting ring 13, and the first sub-rods 11 and the second sub-rods 12 are alternately arranged, that is, the supporting rings 13 surrounded by the first sub-rods 11 and the supporting rings 13 surrounded by the second sub-rods 12 are alternately arranged along the circumferential direction Y of the supporting frame 110. The plurality of support rings 13 are overlapped along the circumferential direction Y of the support frame 110, and a portion where any two support rings 13 overlap each other corresponds to one unreserved region 102. Specifically, in fig. 4, the upper middle support ring 13 (surrounded by the first sub-rod 11) overlaps with the two support rings 13 (surrounded by the second sub-rod 12) on the left and right sides and forms two non-reserved areas 102, and the two non-reserved areas 102 are located on both sides of the reserved area 101 along the circumferential direction Y of the support frame 110. Any one support ring 13 and two adjacent support rings 13 overlap each other along the circumferential direction Y of the support frame 110, so that the support frame 110 forms a mesh structure, and further structural stability in the circumferential direction Y between the plurality of support rings 13 of the plugging device 100A is improved.

In other embodiments, the first pole 10 includes a first sub-pole 11 and a second sub-pole 12. The first sub-rod 11 is wound into a supporting ring 13, and the second sub-rod 12 divides the area surrounded by the supporting ring 13 into a reserved area 101 and an unreserved area 102, so that the reserved area 101 is ensured to have a larger area, and a pipe body with a larger outer diameter passes through.

It will be appreciated that the smaller the ratio of γ/β, the smaller the ratio of the support ring 13 for circumferential overlap with the remaining first bars 10, i.e. along the circumferential direction Y of the support frame 110, the sparsely arranged support ring 13 with the remaining first bars 10, thereby facilitating realization of a large mesh structure of the support frame 110. The application combines the structural stability of the support frame 110 in the circumferential direction Y and the large mesh structure by setting the gamma/beta of 0 < gamma/beta to be less than or equal to 0.6. The ratio of γ/β may be, but is not limited to, 0.1, 0.2, 0.3, 0.4, 0.5, or 0.6, etc. It should be noted that the ratio of γ/β is merely for illustration, and the present application is not particularly limited.

In some embodiments, the second sub-rod 12 is located outside the region corresponding to the support ring 13 surrounded by the first sub-rod 11, and at least part of the second sub-rod 12 is disposed adjacent to the support ring 13. In this way, the points or sections of the mutual fixed connection can be added at the positions where the second sub-rod 12 and the supporting ring 13 are mutually adjacent to improve the connection area of the supporting ring 13 and the second sub-rod 12, so that the binding between the supporting ring 13 and the second sub-rod 12 in the plugging device 100A is stronger, the deformation resistance of the plugging device 100A is improved, the plugging device 100A is conveniently attached to the room space, and the residual shunt is effectively reduced.

The support ring 13 comprises a plurality of intersections 16 interconnecting the second sub-rods 12. The intersection point 16 farthest from the converging member 130 among all the intersection points 16 on one support ring 13 is defined as a separation point 161. Along the radial direction X of the support frame 110, the projection of the maximum distance between any position point on the support ring 13 and the beam converging member 130 on the projection plane P1 is a first dimension, and the projection of the distance between the separation point 161 and the beam converging member 130 on the projection plane P1 is a second dimension. The first size and the second size satisfy the relation: 0.5 < M/N < 0.9, where N is denoted as a first dimension and M is denoted as a second dimension.

Specifically, the support ring 13 formed by winding the first sub-rod 11 includes a plurality of intersecting points 16 that are connected to the second sub-rod 12, as shown in fig. 4, the plurality of intersecting points 16 are different from the converging member 130, wherein the intersecting point 16 farthest from the converging member 130 is used as a separation point 161, and the remaining intersecting points 16 are closer to the converging member 130 than the separation point 161 and are used as contact points 162 where the support ring 13 contacts the second sub-rod 12. The contact point 162 is provided near the convergence member 130, thereby improving the connection strength of the support bracket 110 and the convergence member 130.

In some embodiments, the support bracket 110 includes at least one perimeter Xiang Duan and a plurality of radial segments 60, all of the circumferential segments 50 being disposed along the circumferential direction Y of the support bracket 110 and forming a perimeter of the support bracket 110. Each perimeter Xiang Duan includes two ends 505 that are opposite in the circumferential direction Y of the support bracket 110. The radial segment 60 is connected between the corresponding end 505 and the constriction 130, and at least one of the circumferences Xiang Duan 50 is provided with a peak 51. In the circumferential direction Y of the occlusion device 100A, a peak 51 is located between the two ends 505 of its associated circumferential section 50, wherein the peak 51 is the apex of its associated circumferential section 50 protruding outwards in the radial direction X of the occlusion device 100A. In this way, when the supporting frame 110 receives an external force, the stress is concentrated at the position of the peak 51, the supporting frame 110 is folded at two circumferential sides of the position of the peak 51, and when the position of the peak 51 guides other adjacent parts to the peak to receive the sheath, the supporting frame 110 extends and deforms towards the peak 51, so that the supporting frame 110 is compressed in the radial direction X, and the sheath is convenient to receive; on the other hand, in the process of releasing the scaffold 110 from the sheath, the position of the peak 51 is released first, and the part of the supporting ring 13 connected with the peak 51 is sequentially released from the sheath, so that the release is smooth. It will be appreciated that if the circumferential section 50 of the support ring 13 is provided with a plurality of peaks and a plurality of valleys at the peripheral edge of the plugging device 100A, after the plugging device 100A is compressed in the radial direction X, the stress of the circumferential section 50 is dispersed, the compression effect is poor, the space occupied after compression is large, the radial binding force received in the sheath tube of the same specification is large, the friction force during the delivery is large, and therefore the force required during the sheath retraction is large, so that the sheath retraction is not easy.

Optionally, in some embodiments, along the circumferential direction of the plugging device 100A, the peak 51 is disposed at the middle position of the circumferential section 50 to which the peak 51 belongs, so that the two circumferential sides of the support frame 110 at the position of the peak 51 are more beneficial to be folded mutually, so that the whole periphery of the support frame 110 is uniformly stressed, the damage or the stimulation to the tissue is reduced, and the sheath retraction and the release are facilitated.

In this embodiment, the radial segment 60 of each support ring 13 is provided with a peak 51 to facilitate the resheathing and release of the occluding device 100A. In some embodiments, the radial segment 60 of the partial support ring 13 is provided with one peak 51.

Other features of the support frame 110, the converging member 130, etc. of the plugging device 100A in this embodiment can refer to the first embodiment, and will not be described in detail herein.

Referring to fig. 5 to 7, fig. 5 is a projection view of a plugging device 100B according to a third embodiment of the present application formed on a projection plane, fig. 6 is a projection view of a plugging device 100C according to a fourth embodiment of the present application formed on a projection plane, and fig. 7 is a projection view of a plugging device 100D according to a fifth embodiment of the present application formed on a projection plane. The occluding devices 100B, 100C, 100D include a support stent 110 and a cover 150. The occluding devices 100B, 100C, 100D provided in the third, fourth and fifth embodiments differ from the occluding device 100 provided in the first embodiment mainly in that the circumferential section 50 of the supporting frame 110 is provided with one peak 51. The support frame 110 includes three support rings 13 having the same structure. The three support rings 13 are formed by winding a first rod 10 of non-degradable material.

In a third embodiment, as shown in fig. 5, the radial segments 60 are configured as straight segments. The two radial segments 60 of each support ring 13 are symmetrically arranged along the line from the peak 51 to the constriction 130. The crest 51 on the circumferential section 50 is configured as the protrusion 511 protruding towards the side away from the constriction 130 of the circumferential section 50, the width of the protrusion 511 is increased relative to other sections on the circumferential section 50, that is, the material consumption of the protrusion 511 relative to other sections on the circumferential section 50 is increased, so that the problem that the support frame 110 breaks in the sheath folding process is prevented, and the overall structural strength of the plugging device 100B is improved. The protrusions 511 are generally tapered with rounded corners on the radially outer sides to facilitate folding of the support frame 110 and to avoid scoring tissue. The edge of the side of the peak 51 facing the constriction 130 is straight. The edge of the side of the support ring 13 facing away from the constriction 130 is curved and protrudes away from the constriction 130, and the edge of the side of the support ring 13 facing towards the constriction 130 is straight.

In this embodiment, the support frame 110 of the occluding device 100B is configured as a cutting stent. The radial segments 60 of the support rings 13 are configured as straight segments, and adjacent two support rings 13 share one radial segment 60. Thus, on one hand, the plugging device 100B in the embodiment of the present application has better resilience after being implanted into a human body; on the other hand, as the connecting area between the plurality of support rings 13 is larger, the constraint between the support rings 13 in the plugging device 100B is stronger, which is beneficial to improving the deformation resistance of the plugging device 100B and the adhesion of the plugging device 100B on the room space, and effectively reducing the residual shunt; on the other hand, the processing technology is simplified, the metal content in the plugging device is reduced, the shape of the reserved area 101 is simple, and the puncture area 1011 of the reserved area 101 can be conveniently used for allowing a pipe body with a larger outer diameter to pass through. The edge of the puncture area 1011 is arranged at intervals with the radial section 60, so that the interference between the tube body and the supporting ring 13 is avoided to influence the puncture operation effect. In some embodiments, two adjacent support rings 13 may also have independent radial segments 60. In the present embodiment, the distance between the separation point 161 of two adjacent support rings 13 and the converging member 130 is smaller than the distance between the peak 51 and the converging member 130, the bending degree at the separation point 161 is larger, and the stress is more concentrated, so as to radially compress the support frame 110 in the sheath retracting process.

In a fourth embodiment, as shown in fig. 6, the radial segments 60 are configured as arcuate segments. The two radial segments 60 of each support ring 13 are arranged asymmetrically along the line from the peak 51 to the constriction 130. The plurality of radial segments 60 are arranged in a spiral. The peaks 51 on the circumferential section 50 are configured such that the circumferential section 50 is bent toward a side away from the converging member 130 to form the peaks 51. The side of the peak 51 facing the constriction 130 forms a recess 513. The edge of the side of the support ring 13 facing away from the constriction 130 protrudes in a direction away from the constriction 130, and the edge of the side of the support ring 13 facing towards the constriction 130 protrudes in a direction away from the constriction 130. Preferably, the individual positions of the circumferential sections 50 are of uniform width, i.e. the circumferential sections 50 are oriented parallel to the direction of extension of the two edges facing away from the constriction 130. The wave crest 51 forms a groove 513 toward one side of the converging member 130, and when the two circumferential sides of the supporting frame 110 at the position of the wave crest 51 are folded with each other, the groove 513 can provide a buffer space for deformation of the wave crest 51, thereby facilitating sheath retraction and release of the supporting frame 110.

As shown in fig. 7, in the fifth embodiment, the radial segment 60 is configured as an arc segment. The two radial segments 60 of each support ring 13 are arranged asymmetrically along the line from the peak 51 to the constriction 130. The plurality of radial segments 60 are arranged in a spiral. The entire circumferential section 50 is bent in the radial direction X of the support bracket 110 in a direction away from the convergence member 130 to form a bump corresponding to the peak 51 on the circumferential section 50.

Referring again to fig. 5-7, the difference from the fourth embodiment is that in the fifth and sixth embodiments, the support frame 110 of the occluding device 100C, 100D may be configured as a cut stent or a braided stent. The two adjacent support rings 13 share one radial section 60, and the radial sections 60 are configured as arc-shaped sections, so that the processing technology is simplified, the metal content in the plugging device is reduced, the shape of the reserved area 101 is simple, and the puncture area 1011 of the reserved area 101 can be used for passing through a pipe body with a larger outer diameter. On the other hand, the radial dimension of the separation points 161 of the adjacent two support rings 13 in the occluding device 100C, 100D is closer to the radius of the support rings 13 than the separation points 161 of the adjacent two support rings 13 in the occluding device 100B, thereby ensuring that the circumferential force of the support frame 110 tends to be more uniform, not only that the circumferential section 50 is relatively less likely to deform after the tissue breach is released, so that the occluding device 100A can be firmly fixed on the atrial septum, but also that the circumferential section 50 is facilitated to apply clamping force to the tissue more uniformly, reducing irritation to the tissue, and that the occluding devices 100C, 100D are more flexible and comfortable.

Other features of the support frame 110, the constriction member 130, etc. of the plugging devices 100B, 100C, 100D according to the third to fifth embodiments can be referred to the first embodiment, and will not be described in detail herein.

Referring to fig. 3 and fig. 8 to fig. 9 together, fig. 8 is a projection view of a plugging device 100E according to a sixth embodiment of the present application formed on a projection plane, and fig. 9 is a projection view of a plugging device 100F according to a seventh embodiment of the present application formed on a projection plane. The occluding devices 100E, 100F include a stent 110 and a cover 150. The occluding devices 100E, 100F provided in the sixth and seventh embodiments differ from the occluding device 100 provided in the first embodiment mainly in that the circumferential section 50 of the supporting frame 110 is provided with one trough 54 and a first peak 52 and a second peak 53.

The support bracket 110 includes at least one perimeter Xiang Duan and a plurality of radial segments 60, all of the circumferential segments 50 being disposed along the circumferential direction Y of the support bracket 110 and forming a perimeter of the support bracket 110. Each perimeter Xiang Duan includes opposite ends 505 in the circumferential direction of the support bracket 110. The radial segments 60 are connected between the corresponding ends 505 and the convergence 130. At least one perimeter Xiang Duan has a first peak 52, a second peak 53 and a trough 54 disposed thereon. Along the circumferential direction Y of the supporting frame 110, the first peaks 52, the troughs 54 and the second peaks 53 are arranged in sequence and are located between two ends 505 of the circumferential section 50 to which they belong. Wherein the first peak 52 and the second peak 53 are peaks of the associated circumferential section 50 protruding outwards in the radial direction X of the occlusion device 100E, 100F, and the trough 54 is a peak of the associated circumferential section 50 protruding inwards in the radial direction X of the occlusion device 100E, 100F. In this way, on the one hand, the trough 54 can serve as a stress concentration point at the periphery of the support frame 110 of the plugging device 100E, 100F, and the support frame 110 is folded or expanded on two circumferential sides of the trough 54, so as to facilitate the sheath retraction and release of the plugging device 100E, 100F.

In some embodiments, along the radial direction X of the supporting frame 110, the distance between the trough 54 and the beam-gathering member 130 is projected as a first distance on the projection plane P1, the distance between the first peak 52 and the beam-gathering member 130 is projected as a second distance on the projection plane P1, the distance between the second peak 53 and the beam-gathering member 130 is projected as a third distance on the projection plane P1, and both the second distance and the third distance are greater than the first distance. Because the trough 54 is clamped between the two peaks, the circumferential section 50 is conveniently formed into a form with larger curvature at the position of the trough 54, so that the stress of the circumferential section 50 at the position of the trough 54 in the deformation process of the supporting frame 110 is concentrated, the compression and the expansion of the supporting rods 120 are conveniently carried out at the two sides of the position of the trough 54, and the sheath retraction and the release of the plugging devices 100E and 100F are conveniently carried out. Illustratively, in the present embodiment, the projection of the distance between the trough 54 and the beam-converging element 130 at the projection plane P1 refers to the distance between the projection point of the trough 54 at the projection plane P1 and the projection point of the geometric center point of the beam-converging element 130 at the projection plane P1; the projection of the distance between the first peak 52 and the beam-converging element 130 on the projection plane P1 refers to the distance between the projection point of the first peak 52 on the projection plane P1 and the projection point of the geometric center point of the beam-converging element 130 on the projection plane P1; the projection of the second peak 53 on the projection plane P1 and the distance between the second peak 53 and the converging element 130 are the distances between the projection point of the second peak 53 on the projection plane P1 and the projection point of the geometric center point of the converging element 130 on the projection plane P1. In some embodiments, the projection of the distance between the trough 54, the first peak 52 or the second peak 53 and the beam-converging member 130 on the projection plane P1 may be the distance between the projection point of the trough 54, the first peak 52 or the second peak 53 on the projection plane P1 and the projection point of the outer peripheral surface of the beam-converging member 130 on the projection plane P1, which is not particularly limited in the present application.

The trough 54, the first crest 52 and the second crest 53 may be provided on one support ring 13; alternatively, some or all of the support rings 13 are provided with valleys 54, first peaks 52 and second peaks 53. In this embodiment, each support ring 13 has the same structure, and each support ring 13 is provided with a first peak 52, a second peak 53 and a trough 54.

Optionally, in some embodiments, the first distance satisfies the relationship: 0.5 < D/E < 0.9, wherein D is denoted as first distance and E is denoted as second distance and/or third distance. Thus, the plugging devices 100E and 100F not only can consider the area of the reserved area 101, but also can ensure a plurality of parameters such as the plugging area, the sheath retraction force, the metal content and the like, have better plugging performance and safety and reliability, and are beneficial to secondary puncture. In this embodiment, the second distance is equal to the third distance, and in other embodiments, the second distance may not be equal to the third distance.

It will be appreciated that when the ratio of D/E tends to be 1, the larger the occlusion area of the occluding devices 100E, 100F, the greater the amount of occlusion of the foramen ovale, and the more effective the occlusion of the residual shunt. In addition, because the plugging devices 100E and 100F are stressed more uniformly in the circumferential direction Y, the plugging devices 100E and 100F have smaller stimulation to tissues after implantation, and the plugging devices with proper specifications can be used for plugging the foramen ovale, so that the secondary puncture of the interatrial septum is facilitated. When the D/E ratio tends to be 0, the more severely the scaffold 110 is recessed from the trough 54 toward the constricting element 130, the more concentrated the stress of the circumferential segment 50 at the trough 54 is, the less difficult the sheath is to be retracted by the plugging devices 100E, 100F, the scaffold 110 has a small area, and the larger the metal content is, which is liable to cause residual shunting. Therefore, the application combines the plugging performance, the penetrability and the safety performance of the plugging devices 100E and 100F by setting the D/E to be more than 0.5 and less than 0.9. The ratio of D/E may be, but is not limited to, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, or 0.85, etc. It should be noted that the D/E ratio is merely for illustration, and the present application is not particularly limited.

As shown in fig. 8 and 9, in at least one support ring 13, along the radial direction X of the support frame 110, the projection of the maximum dimension between any point on the support ring 13 and the converging member 130 on the projection plane P1 is a first dimension N, which can be regarded as the projection of the radius of the support ring 13 on the projection plane P1. The distance between the separation point 161 and the converging element 130 is projected at the projection plane P1 to a second dimension M, in this embodiment M < N, preferably 0.5 < M/N < 0.9.

Optionally, in some embodiments, the second dimension M is equal to the first distance D, so that the bending curvature of the support rod at the positions of the separation point 161 and the trough 54 is substantially consistent, so that the positions of the separation point 161 and the trough 54 can be radially compressed easily in the sheath receiving process, and the sheath receiving force is smaller. In some embodiments, the second dimension M is less than the first distance D, which facilitates shaping the strut at the location of the separation point 161 to a form with a greater bending curvature, creating a stress concentration point, reducing the sheath retraction force. In some embodiments, the second dimension M is greater than the first distance D.

Specifically, as shown in fig. 8, in the sixth embodiment, the support bracket 110 includes four support rings 13 having the same structure. The four support rings 13 are formed by winding a first rod 10 of non-degradable material. The support ring 13 is substantially heart-shaped. Four support rings 13 are arranged adjacently. The plurality of radial segments 60 are each configured as a straight segment. The circumferential section 50 is concave in the radial direction X of the support bracket 110 toward the converging member 130 to form one trough 54, a first peak 52, and a second peak 53. In the present embodiment, the bending curvatures of the first peak 52 and the second peak 53 are the same, and the second distance is equal to the third distance. In some embodiments, the curved curvatures of the first peak 52 and the second peak 53 may also be different, and the second distance may also be different from the third distance. In this embodiment, the curved curvature of the valleys 54 is greater than the first peaks 52 and the second peaks 53 so that the stresses are relatively concentrated at the valleys 54.

Optionally, in some embodiments, the trough 54 is disposed at a middle position of the circumferential section 50 to which the trough 54 belongs along the circumferential direction of the plugging device 100E, so that the two circumferential sides of the support frame 110 at the trough 54 position are more beneficial to fold mutually, so that the whole periphery of the support frame 110 is uniformly stressed, the damage or the irritation to the tissue is reduced, and the sheath retraction and the release are facilitated. In some embodiments, the trough 54 may be designed according to the shape, size, type of the conveyor of the support frame 110, and the like, for example, along the circumferential direction of the plugging device 100E, the trough 54 is disposed at the rest position except the middle position in the circumferential section 50 to which the plugging device belongs, and the present application is not limited in particular.

In this embodiment, the support frame 110 of the occluding device 100E is configured as a cutting stent. The radial segments 60 of the support rings 13 are configured as straight segments, and adjacent two support rings 13 share one radial segment 60, the radial segments 60 in the same support ring 13 being wider relative to the circumferential segments 50. Thus, on the one hand, the plugging device 100E in the embodiment of the present application has better resilience after being implanted into a human body; on the other hand, the connection area between the plurality of support rings 13 is larger, so that the constraint between the support rings 13 in the plugging device 100E is stronger, the deformation resistance of the plugging device 100B is improved, the plugging device 100E is attached to the room space, and the residual shunt is effectively reduced. In some embodiments, the radial segments 60 in the same support ring 13 are of uniform width as the circumferential segments 50, and adjacent two support rings 13 may also have independent radial segments 60.

Specifically, as shown in fig. 9, in the seventh embodiment, the support bracket 110 includes three support rings 13 having the same structure. The support ring 13 is substantially irregularly shaped. Three support rings 13 are arranged next to each other. The plurality of radial segments 60 are each configured as an arcuate segment. The valleys 54 are configured such that the associated circumferential segment 50 bends toward the side proximate to the beamer 130 to form the valleys 54. The circumferential section 50 is divided by the trough 54 to form a first sub-circumferential section 502 and a second sub-circumferential section 503, the first peak 52 is configured such that the first sub-circumferential section 502 to which it belongs is bent toward a side away from the converging member 130 to form the first peak 52, and the second peak 53 is configured such that the second sub-circumferential section 503 to which it belongs is bent toward a side away from the converging member 130 to form the second peak 53. The first wave crest 51 and the second wave crest 53 both form a groove 513 on the side facing the converging member 130, the wave trough 54 forms a protrusion 511 on the side facing the converging member 130, i.e. the wave trough 54 forms a groove on the side facing away from the converging member 130, i.e. the edge of the side of the supporting ring 13 facing the converging member 130 is arc-shaped, and the edge of the side of the supporting ring 13 facing away from the converging member 130 is arc-shaped.

In this embodiment, the support frame 110 of the occluding device 100F may be configured as a cut stent or a braided stent. The radial segments 60 of the support rings 13 are configured as arcuate segments, and adjacent two support rings 13 share one radial segment 60. Thus, on one hand, the plugging device 100F in the embodiment of the present application has better resilience after being implanted into a human body; on the other hand, as the connecting area between the plurality of support rings 13 is larger, the constraint between the support rings 13 in the plugging device 100F is stronger, which is beneficial to improving the deformation resistance of the plugging device 100F, facilitating the attachment of the plugging device 100F on the room space and effectively reducing the residual shunt; in yet another aspect, the processing is simplified, the metal content in the occluding device 100F is reduced, and the shape of the retention area 101 is simplified. In some embodiments, two adjacent support rings 13 may also have independent radial segments 60.

In this embodiment, or in other embodiments, the common radial segment 60 may be one section of one support rod 120, or may be a section where a plurality of adjacent support rods are connected to one another. The common radial segment 60 may be obtained by extending adjacent support rods in parallel, braiding, bonding, stitching, hot pressing, melting, etc. along the same trajectory for a distance.

Other features of the support frame 110, the constriction member 130, etc. of the plugging apparatus 100E, 100F in the sixth embodiment to the seventh embodiment can be referred to the first embodiment, and will not be described in detail herein.

Referring to fig. 10 together, fig. 10 is a projection view of an occlusion device 100G according to an eighth embodiment of the present application formed on a projection plane. The occluding device 100G includes a stent 110 and a cover 150. The main difference between the plugging device 100G provided in the eighth embodiment and the plugging device 100B provided in the third embodiment is that the number of support rings 13 of the support frame 110 and the structure and arrangement of the support rings 13 are different from those in the third embodiment.

In the present embodiment, the support bracket 110 has six support rings 13. Six support rings 13 are formed by winding a first rod 10 of non-degradable material. Illustratively, the six support rings 13 are identical in structure and size. Six support rings 13 are arranged adjacent to each other. Specifically, the radial segments 60 of the support rings 13 are configured as straight segments, and two radial segments 60 of two adjacent support rings 13 at the junction are abutted, i.e., any two adjacent support rings 13 share one radial segment 60. Thus, on one hand, the plugging device 100G in the embodiment of the present application has better resilience after being implanted into a human body; on the other hand, as the connecting area between the plurality of support rings 13 is larger, the constraint between the support rings 13 in the plugging device 100G is stronger, which is beneficial to improving the deformation resistance of the plugging device 100G and the adhesion of the plugging device 100G on the room space, and effectively reducing the residual shunt; in yet another aspect, the processing is simplified, the metal content in the occluding device is reduced, and the shape of the retention area 101 is simplified. At least part of the circumferential section 50 of the support ring 13 is provided with a peak 51 to facilitate the sheathing and release of the occluding device 100G.

The location of the separation point 161 is close to the periphery of the occluding device 100G, so that the stress on the circumferential section 50 tends to be more uniform, the circumferential section 50 is relatively not easy to deform after the tissue notch is released, the occluding device 100G can be firmly fixed on the atrial septum, the circumferential section 50 can apply clamping force to the tissue more uniformly, the irritation to the tissue is reduced, and the occluding device 100G is more soft and comfortable.

Other features of the support frame 110, the constriction member 130, etc. of the plugging apparatus 100G according to the eighth embodiment can refer to the third embodiment, and will not be described in detail herein.

Referring to fig. 11 together, fig. 11 is a projection view of a plugging device 100H according to a ninth embodiment of the present application formed on a projection plane. The occluding device 100H includes a stent 110 and a cover 150. The main difference between the plugging device 100H provided in the ninth embodiment and the plugging device 100F provided in the seventh embodiment is that the number of support rings 13 of the support frame 110 and the structure and arrangement of the support rings 13 are different from those of the first embodiment.

In the present embodiment, the support rod 120 made of a non-degradable material is defined as the first rod 10, and the support rod 120 made of a degradable material is defined as the second rod 20. The support bracket 110 includes three support rings 13, each support ring 13 being formed by winding the first rod 10. Each support ring 13 comprises two circumferences Xiang Duan and two radial segments 60. Three second rods 20 are disposed in the reserved area 101 surrounded by each supporting ring 13, and one end of each second rod 20 is connected with the first rod 10, and the other end is connected with the converging member 130. In some embodiments, one second rod 20, two second rods 20, or more than three second rods 20 may be disposed in the reserved area 101 surrounded by the support ring 13, and the present application is not limited in particular. In other embodiments, the second rod 20 is disposed outside the reserved area 101 enclosed by the support ring 13. According to the application, the second rod 20 is arranged in the support ring 13, so that the deformation resistance of the plugging device 100H is improved, the plugging device 100H is attached to the atrial septum, residual shunt is effectively reduced, the support ring 13 can have a large mesh structure after the second rod 20 is degraded, eroded and metabolized, and a puncture channel for later interventional therapy is conveniently constructed in the reserved area 101.

Other features of the support frame 110, the constriction member 130, etc. of the plugging apparatus 100H according to the ninth embodiment can be referred to the first embodiment, and will not be described in detail herein.

The present application also provides an occlusion system comprising a conveyor for conveying occlusion devices 100, 100A, 100B, 100C, 100D, 100E, 100F, 100G, 100H to a tissue gap, as well as occlusion devices 100, 100A, 100B, 100C, 100D, 100E, 100F, 100G, 100H as above. The delivery device may include, but is not limited to, a sheath for receiving the occluding device 100 and a control handle secured to the proximal end of the sheath. The control handle is used for controlling the plugging devices 100, 100A, 100B, 100C, 100D, 100E, 100F, 100G and 100H to extend out of the sheath tube and release to the tissue notch; alternatively, the device is used to control the recovery of the occluding devices 100, 100A, 100B, 100C, 100D, 100E, 100F, 100G, 100H into the sheath. It will be appreciated by those skilled in the art that the conveyor may be constructed in any known manner and that the application is not particularly limited.

It should be noted that, the specific technical solutions in the above embodiments may be mutually applicable under the condition of no contradiction, and are not described herein again.

The foregoing has outlined rather broadly the more detailed description of embodiments of the application, wherein the principles and embodiments of the application are explained in detail using specific examples, the above examples being provided solely to facilitate the understanding of the method and core concepts of the application; meanwhile, as those skilled in the art will appreciate, modifications will be made in the specific embodiments and application scope in accordance with the idea of the present application, and the present disclosure should not be construed as limiting the present application.

Claims

1. The plugging device is characterized by comprising a supporting frame for plugging a tissue gap, wherein the supporting frame is formed by connecting a plurality of supporting rods, the supporting rods comprise first rods made of non-degradable materials, the first rods enclose a closed reserved area, in a natural state, the reserved area can be penetrated by a pipe body with the outer diameter being greater than or equal to 2mm, the supporting frame further comprises a converging piece, the converging piece is used for converging at least part of the supporting rods, the first rods comprise first sub-rods, the first sub-rods are wound into a supporting ring, in the natural state, a closed area enclosed by the supporting ring covers the reserved area, the supporting ring comprises at least one intersection point connected with other supporting rods, and a plane perpendicular to the axis of the supporting frame is a projection plane;

the intersection point farthest from the beam converging piece in all the intersection points is defined as a separation point, the projection of the maximum distance between any position point on the support ring and the beam converging piece on the projection plane is a first size, the projection of the distance between the separation point and the beam converging piece on the projection plane is a second size, and the first size and the second size satisfy the relation: 0.5 < M/N < 0.9, wherein N is expressed as the first dimension and M is expressed as the second dimension.

2. The occlusion device of claim 1, wherein in said natural state said retention area is capable of being traversed by a tubular body having an outer diameter greater than or equal to 8mm and/or said retention area is capable of being traversed by a tubular body having an outer diameter less than or equal to 12 mm.

3. The occlusion device of claim 1, wherein in said natural state said retention area comprises a puncture area, said puncture area being an area of said retention area through which a tube of maximum outer diameter can pass, said puncture area being projected as a circle on said projection plane.

4. The plugging device of claim 3 wherein the projection of the sector of minimum central angle surrounding the puncture area on the projection plane is a first sector, the central angle of the first sector being a first central angle, the first central angle being 45 ° -150 °.

5. The occlusion device of claim 4, wherein said first central angle is 60 ° to 120 °.

6. The plugging device of claim 4, wherein a projection of a sector having a smallest central angle surrounding the support ring on the projection plane with the converging element as a center is a second sector having a second central angle of 45 ° to 160 °.

7. The occlusion device of claim 6, wherein said first stem further comprises at least a second sub-stem connected to said first sub-stem and said constriction, at least a portion of said second sub-stem being located within said support ring; in the natural state, the second sub-rod divides the area surrounded by the supporting ring into at least one reserved area and at least one non-reserved area;

and taking the beam converging piece as a circle center, and the projection of a sector area with the smallest central angle surrounding one unreserved area on the projection plane is a third sector area, wherein the central angle of the third sector area is a third central angle, the third central angle is marked as gamma, and the second central angle is marked as beta, wherein the gamma/beta is more than 0 and less than or equal to 0.6.

8. The occlusion device of claim 1, wherein said first dimension and said second dimension satisfy the relationship: M/N is more than 0.7 and less than 0.9.

9. The occlusion device of any of claims 1-8, wherein at least a portion of said support rods are interconnected by braiding.

10. The occlusion device of any of claims 1-8, wherein said first stem comprises a metal stem made of a metal material, said metal stem being disposed outside said retention area.

11. The occlusion device of any of claims 1-8, wherein said support frame further comprises a second rod, said second rod being at least partially made of a degradable material, at least one of said second rods being connected to said first rod.

12. The plugging device of any one of claims 3-8, wherein the support frame comprises at least one circumferential section and a plurality of radial sections, all of the circumferential sections being disposed along the circumferential direction of the support frame and forming the periphery of the support frame, each circumferential section comprising two ends that are opposite in the circumferential direction of the support frame, the radial sections being connected between the corresponding ends and the constriction, at least one of the circumferential sections being provided with a peak that is located between the two ends of the circumferential section to which it belongs along the circumferential direction of the support frame, wherein the peak is the apex of the circumferential section to which it belongs that projects outwardly in the radial direction of the support frame.

13. The plugging device of any one of claims 3-8, wherein the support frame comprises at least one circumferential section and a plurality of radial sections, all the circumferential sections are arranged along the circumferential direction of the support frame and form the periphery of the support frame, each circumferential section comprises two opposite ends in the circumferential direction of the support frame, the radial sections are connected between the corresponding ends and the converging piece, at least one circumferential section is provided with a first peak, a second peak and a trough, the first peak, the trough and the second peak are arranged in sequence along the circumferential direction of the support frame and are all positioned between the two ends of the circumferential section to which the first peak and the second peak belong, wherein the first peak and the second peak are peaks of the circumferential section which protrude outwards along the radial direction of the support frame, and the trough is a peak of the circumferential section which protrudes inwards along the radial direction of the support frame.

14. The occlusion device of claim 13, wherein a projection of a distance of said trough from said constriction in said projection plane is a first distance, a projection of a distance of said first peak from said constriction in said projection plane is a second distance, a projection of a distance of said second peak from said constriction in said projection plane is a third distance, and both said second distance and said third distance are greater than said first distance.

15. The occlusion device of claim 14, wherein said first distance satisfies the relationship: 0.5 < D/E < 0.9, wherein D is denoted as the first distance and E is denoted as the second distance and/or the third distance.

16. The occlusion device of any of claims 1-8, wherein the number of said reserved areas is 3-8.

17. The occlusion device of any of claims 1-8, further comprising a cover disposed on the support frame.

18. The occlusion device of claim 17, wherein said cover film is made of a degradable material at a location corresponding to said retention area.

19. An occlusion system comprising a delivery device for delivering the occlusion device to the tissue site and the occlusion device of any of claims 1-18.