WO2018121348A1 - 封堵器及封堵器的缝合方法 - Google Patents

封堵器及封堵器的缝合方法 Download PDF

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Publication number
WO2018121348A1
WO2018121348A1 PCT/CN2017/117195 CN2017117195W WO2018121348A1 WO 2018121348 A1 WO2018121348 A1 WO 2018121348A1 CN 2017117195 W CN2017117195 W CN 2017117195W WO 2018121348 A1 WO2018121348 A1 WO 2018121348A1
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WIPO (PCT)
Prior art keywords
occluder
intersection
suture
disc
film
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PCT/CN2017/117195
Other languages
English (en)
French (fr)
Inventor
张�杰
陈贤淼
邓月英
李文锋
Original Assignee
先健科技(深圳)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to US16/474,711 priority Critical patent/US11337684B2/en
Priority to ES17886551T priority patent/ES2966976T3/es
Priority to EP17886551.5A priority patent/EP3563773B1/en
Publication of WO2018121348A1 publication Critical patent/WO2018121348A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/06—At least partially resorbable materials
    • A61L17/10—At least partially resorbable materials containing macromolecular materials
    • A61L17/12—Homopolymers or copolymers of glycolic acid or lactic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592—Elastic or resilient implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00597—Implements comprising a membrane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00601—Implements entirely comprised between the two sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/00663—Type of implements the implement being a suture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect

Definitions

  • the invention relates to the technical field of medical instruments, and in particular to a method for suturing an occluder and an occluder.
  • the cardiac defect occluder is an implantable medical device for treating congenital heart defects.
  • the usual structure mainly includes a sealing disc, a baffle, and a suture.
  • the choke membrane acts to block the defect and block the blood shunt.
  • the baffle is secured to the edge of the largest diameter of the sealing disk by suture stitching.
  • occluders Most of the occluders currently used on the market are woven from nickel-titanium alloy wire. Due to the long-term existence of nickel-titanium alloy wire in the human body, it is easy to cause the rejection of biological organisms, and because of the presence of nickel ions, it is easy to cause allergies and corresponding complications, even a certain degree of damage, which will affect the heart of undeveloped patients. Development and growth. In recent years, an absorbable occluder has been developed which is woven from a biodegradable material such as a polymer material.
  • the absorbable occluder can be decomposed into small molecules that are harmless to the human body, and can be excluded from the body through the metabolism of the human body, thereby avoiding the long-term influence of the human body by foreign bodies.
  • the sealing disk when the sealing disk is received into the sheath, the intersection of the sealing disk mesh and the suture is moved toward the distal end of the occluder due to the pushing action of the sheath opening edge on the suture during the process. Thus, the choke film is crimped.
  • the resilience of the sealing disk which is woven by the polymer material is more than nickel due to the mesh crossing point of the sealing disk moving into the sheath tube during the process of entering the sheath tube.
  • the sealing disk formed by the titanium wire has poor resilience, so that the disk surface of the sealing disk of the occluder becomes large, and then the occluder is released (that is, the occluder is in a natural state free from external force), and the flow blockage
  • the edge of the membrane cannot reach the edge of the sealing disc surface of the occluder.
  • the present invention provides an occluder comprising a first disc-like structure having a mesh, the first disc-like structure being woven from at least two sets of braided wires, the at least two sets of braided lines intersecting to form a multi-turn cross Point, the first disc-shaped structure is further provided with a baffle film, the edge of the baffle film is connected to the outermost circle intersection of the multi-turn intersection by a suture, and the outermost circle intersection The number of intersections in the suture film is less than the number of intersections in the outermost circle intersection, and the position of the obturator film near the edge thereof passes through the suture and the multi-turn A circle of intersections within the intersection of the outermost circles in the intersection is connected.
  • the flow blocking film is provided with a first stitching hole and a second stitching hole, and the first stitching hole is farther from the center of the choke film than the second stitching hole.
  • the number of the suture holes in the first loop stitching hole is smaller than the number of all the intersection points in the outermost circle intersection point.
  • the second loop stitching hole is stitched by stitching to a circle of intersections of the plurality of loop intersections that are closest to the intersection of the outermost loops.
  • the first loop stitching hole is disposed at an edge of the flow blocking film.
  • each of the first stitching holes has at least one of the second stitching holes between the two stitching holes.
  • the occluder further includes a second disc-shaped structure coupled to the first disc-like structure and coupled between the first disc-shaped structure and the second disc-shaped structure waist.
  • the distal end of the first disc-shaped structure is provided with a distal end cap, the first end of the at least two sets of braided wires is gathered around the distal end cap; the second disc-shaped structure The proximal end is provided with a proximal end cap, the second end of the at least two sets of braided wires opposite the first end being gathered over the proximal end cap.
  • the suture comprises a polylactic acid suture
  • the flow blocking film comprises a polylactic acid barrier film
  • the occluder is a polymeric material occluder.
  • the occluder is woven from 36, 72 or 144 braided wires.
  • the invention also provides a suturing method for an occluder, characterized in that the suturing method comprises: suturing an edge of the baffle film through a suture to an outermost circle of a plurality of turns of the occluder At a circle intersection, the position of the baffle film near the edge is stitched through the suture to a circle of intersections in the outermost circle intersection of the multi-turn intersections.
  • the position of the baffle film near the edge is stitched by the stitch to a circle of intersections of the multi-turn intersections closest to the intersection of the outermost rings.
  • the ends of the suture are knotted after the suture is completed.
  • the occluder of the present invention is released from the sheath tube, it is close to the intersection of the outermost circle with the intersection of the outermost ring at the intersection of the outermost ring and the choke film, and the flow blocking A circle of intersections in the outermost circle intersection of the film suture pushes the edge of the baffle to move, increasing the likelihood that the edge of the baffle will reach the edge of the disk surface of the occluder structure, ie, reduce the resistance
  • the possibility that the edge of the film can not reach the edge of the occluder face increases the possibility that the defect part of the patient is completely blocked, and the safety and effectiveness of the operation are improved.
  • FIG. 1 is a schematic structural view of an occluder according to an embodiment of the present invention.
  • Figure 2 is a partial perspective view of the occluder of Figure 1;
  • FIG. 3 is a schematic structural view of a flow blocking film of the occluder of FIG. 2;
  • FIG. 4 is a schematic structural diagram of an occluder according to still another embodiment of the present invention.
  • the inventive spirit of the present invention lies in that the suture point of the choke membrane and the occluder is placed on different sections of the occluder, and after being released from the sheath tube, with the flow resistance in the intersection of the outermost circle
  • the loop intersection of the film stitching closes to the intersection of the outermost circle, and the intersection of the outermost circle of the suture film suture pushes the edge of the choke film to move, increasing the edge of the choke film to block the plugging
  • the possibility of the edge of the disc surface of the disc-shaped structure that is, the possibility that the edge of the choke film cannot reach the edge of the disc surface of the occluder, and the possibility that the defect portion of the patient is completely blocked is improved, and the possibility is improved.
  • the safety and effectiveness of the surgery is improved.
  • the suture points of the baffle film and the disc-like structure are on different sections, so that the diameter of the occluder section can be reduced, and the sheath-to-suture of the sheath can be reduced when the sheath is introduced.
  • the suture point can make the intersection of the occluder disc-shaped structure and the suture stitching displace to the distal end of the occluder, thereby effectively reducing the possibility of the obstruction film curling phenomenon, thus not only reducing
  • the risk of the choke membrane breaking away from the intersection when entering the sheath also increases the likelihood that the occluder will completely seal the defect under natural conditions.
  • the choke membrane is sutured to the disc-shaped structure of the occluder through two turns of intersection, and the formation of the baffle film can be effectively fixed between the two stitching points, and is stretched into a bundle when the occluder is sheathed.
  • the occluder is not limited to the polymer material occluder, and may also be an occluder formed of other materials (for example, a metal material having a resilience lower than that of the nickel-titanium alloy wire), as long as the resilience of the occluder is higher than that of the nickel-titanium.
  • the occluder made of alloy wire has poor resilience.
  • the structure of the occluder is not limited to a single-layer occluder, and may also be an occluder of a multi-layer mesh structure.
  • the suture point on the choke membrane is not limited to two stitching points, and may be three or four rings. The suture point of the number of turns actually required, the occluder of the present invention will be described below by taking a polymer material occluder as an example.
  • an occluder 1 includes a first disc-shaped structure 10 having a mesh and a baffle film 20 disposed on the first disc-shaped structure 10 .
  • the first disc-like structure 10 may be formed by interlacing at least two sets of braided wires.
  • the first disc-like structure 10 with a mesh can be woven from a polymer material.
  • the polymer material may be selected from the group consisting of polyethylene terephthalate (PET), poly-L-lactide (PLA), poly-glycolide (PGA), and polyhydroxy fatty acid.
  • PET polyethylene terephthalate
  • PLA poly-L-lactide
  • PGA poly-glycolide
  • PHA polyhydroxy fatty acid
  • PDA Poly-hydroxyalkanoate
  • PDO Poly-dioxanone
  • PCL Polycaprolactone
  • the first disc-like structure 10 is formed by interlacing two sets of braided wires.
  • two sets of braided lines are intersected to form a plurality of intersecting points, each of which includes a plurality of intersections, and a plurality of intersections of the same circle intersection are evenly distributed along the circumference of the circle (ie, The distance between adjacent two intersections along the circumference of the circle is equal.
  • Each intersection is formed by two sets of different braided wires.
  • the multi-turn intersection includes the outermost circle intersection 100 of the occluder 1 and the first circle intersection 200 closest to the outermost circle intersection 100.
  • the multi-turn intersection also includes a second circle intersection, a third circle intersection, etc., the second circle intersection is located at the inner ring of the first circle intersection, the third circle intersection point is located at the inner ring of the second circle intersection point, and so on. .
  • the shape and size of the baffle film 20 are determined according to the shape and size of the first disk-shaped structure 10.
  • the flow blocking film 20 is circular and has a diameter equal to the maximum diameter of the first disc-shaped structure 10 to ensure that the choke film 20 can be placed in the first disc-like structure 10, and may also be the first The edges of the disc-like structure 10 are inconsistent, thereby enabling the baffle film 20 to completely cover the largest section of the first disc-like structure 10.
  • a first loop suture hole 210 and a second loop suture hole 220 are disposed at the edge of the choke membrane 20, and each loop suture hole includes a plurality of suture holes.
  • the first stitching hole 210 is disposed at an edge position of the choke film 20, and the distance between each adjacent two stitching holes in the first stitching hole 210 is equal in the circumferential direction of the ring (ie, the first stitching hole)
  • the plurality of suture holes of 210 are uniformly distributed in the circumferential direction of the loop).
  • the second loop suture hole 220 is disposed on the inner side of the first loop suture hole 210, and the distance between each adjacent two suture holes in the second loop suture hole 220 along the circumference of the loop is equal (ie, the second loop stitching
  • the plurality of stitching holes of the hole 220 are evenly distributed in the circumferential direction of the ring).
  • each adjacent two stitches in the first loop of stitching holes 210 The distance between the holes in the circumferential direction of the ring may also be unequal (ie, the plurality of stitch holes of the first stitching hole 210 are non-uniformly distributed in the circumferential direction of the ring), and each of the second stitch holes 220 The distance between adjacent two suture holes along the circumferential direction of the ring may also be unequal (ie, the plurality of suture holes of the second stitching hole 220 are non-uniformly distributed in the circumferential direction of the ring), as long as two adjacent holes There may be at least one suture hole in the second loop suture hole 220 between the first loop suture holes 210.
  • the number of suture holes in the first loop stitching hole 210 is less than the number of intersection points in the outermost circle intersection point 100.
  • the number of the stitching holes in the first stitching hole 210 is half of the number of the intersecting points in the outermost ring intersection 100, and when the blocking film 20 is sewn to the first disk-shaped structure 10, Two adjacent first stitch holes in one stitching hole 210 directly bypass one of the intersections of the outermost ring intersections 100, so that after stitching, half of the intersections of the outermost circle intersections 100 pass through the first
  • the suture of the suture hole in the loop suture hole 210 is sewn to the edge of the choke film 20, reducing the number of suture points on the circumference of the largest diameter of the first disc-like structure 10, thereby reducing the bundle of the first disc-like structure 10
  • the edge of the baffle 20 is sewn to the outermost circle intersection 100 by a suture 70 passing through the first loop suture hole 210, and the position of the baffle film 20 near the edge is sewn to the suture by the suture thread passing through the second loop suture hole 220.
  • the suture point of the baffle film 20 is on a different cross section, at the time of the sheathing
  • the cross section of the outermost circle intersection 100 is the largest section of the occluder 1, and since the partial suture point is at the intersection of the other loops, the maximum cross-sectional area of the occluder 1 is due to the suture point after being deformed into a bundle shape. The reduction is reduced and the sheath is more easily introduced.
  • the friction and compression of the sheath tube 1 against the occluder 1 are correspondingly reduced, and at the same time, due to the reduction in the number of suture points on the largest section, the sheath tube is blocked.
  • the pushing action point at the edge of the membrane 20 is reduced, thereby reducing the deformation of the disc-like structure of the occluder 1 due to the compression of the suture point.
  • each adjacent one of the first-round stitching holes 210 There is a suture hole in the second loop suture hole 220 between the two suture holes, so that when the occluder is released from the sheath tube, the obstruction film 20 is included in the outermost circle intersection 100.
  • the stitched one circle intersection is close to the outermost circle intersection 100, and the choke film 20 is sewn
  • a circle of intersections within the outermost circle intersection 100 can more effectively push the edge movement of the baffle between the two adjacent intersections of the outermost ring intersection 100 and the stapling film 100.
  • the choke film can be more smoothly accommodated in the first disc-shaped structure 10, which reduces the possibility of curling of the choke film 20 in a natural state, and improves the safety and effectiveness of the plugging.
  • the second stitching hole is stitched to the first ring intersection 200 of the occluder, and the first ring intersection 200 is closest to the outermost circle.
  • the second circle intersection 200 here may be closer to the distal end of the occluder 1 than the outermost circle intersection 100, or may be the outermost The circle intersection 100 is near the proximal end of the occluder 1.
  • first loop stitching hole 210 and/or the second loop stitching hole 220 may be omitted, as long as the edge of the baffle film 20 and the position of the blocking film 20 near the edge thereof may pass through the suture.
  • the intersections with the outermost circle intersection 100 and the first circle intersection point 200, respectively, and the number of intersections of the outermost circle intersection 100 that are sewn with the baffle film 20 are smaller than the intersections of the outermost circle intersections 100. Just count.
  • the flow blocking film 20 is sewn to the intersection of the first disc-like structure 10 by a suture 70, the suture 70 is a polylactic acid suture 70, and the choke film 20 is a polylactic acid barrier.
  • Flow film Polylactic acid material is a degradable material that can be absorbed by the human body. It can be understood that the materials of the suture and the obstruction film can also be made of other materials that are easily absorbed by the human body and are harmless to the human body. limited.
  • the occluder 1a further includes a second disc-shaped structure 30a and a waist portion 60a connecting the first disc-shaped structure 10a and the second disc-shaped structure 30a, and the second disc
  • the structure 30a has the same structure as the first disk structure 10a.
  • the first disc-shaped structure 10a and the second disc-shaped structure 30a communicate with each other through the waist portion 60a to form a "work" shape, and when the heart defect is blocked, the first The disc-shaped structure 10a and the second disc-shaped structure 30a are respectively configured to abut against the sidewalls of the defect atrial septum to block the defect of the heart.
  • the occluder can also have any other shape.
  • the structure of the occluder in this embodiment is merely an example and is not intended to limit the structure of the present invention. Those skilled in the art can select any suitable structure under the suggestion of the present invention.
  • the occluder 1a is woven by two sets of braided wires, and the distal end of the first disc-shaped structure 10a is provided with a distal end cap 40a, and the first ends of the two sets of braided wires are gathered around the distal end cap 40a; the proximal end of the second disc-shaped structure 30a is provided with a proximal end cap 50a, and the second ends of the two sets of braided wires are gathered around the proximal end cap 50a.
  • the structural shape of the proximal end cap 50a and the distal end cap 40a is not specifically limited. In the present embodiment, both the proximal end cap 50a and the distal end cap 40a are designed as a cylindrical structure.
  • the number of the braided wires is generally an even number, and the number may be 36, 72, 144, etc., and is not specifically limited herein.
  • the occluder 1a is 36
  • the braided wire is woven, so the number of the outermost circle intersections is 18, the number of stitching points at the intersection of the choke film and the outermost ring is 9, and the number of stitching points at the intersection with the first circle There are nine, which greatly reduces the cross-sectional area of the occluder 1a when it is sheathed.
  • the number and position of the suture points on the choke film 20 are determined, and the round polylactic acid barrier which is cut by the tweezers is used.
  • the flow film 20 is placed into the first disc-like structure 10 through a grid of a predetermined type of occluder 1; then, the choke film 20 is flattened with tweezers to be evenly placed in the first disc-like structure 10.
  • the edge of the baffle film 20 is ensured to conform to the edge of the disk surface of the first disk-shaped structure 10; then, the outermost ring intersection 100 adjacent to the edge of the disk surface and the intersection of the first ring 200 are selected, and the edge of the choke film 20 is to be used. Between the selected upper and lower turns, the needle of the polylactic acid suture thread is passed through the first stitching hole 210 at the edge of the choke film 20, and is routed to an intersection 101 of the outermost circle intersection.
  • intersection is hooked from the inner top to the outer side of the intersection, and then the needle is passed to an intersection 201 of the adjacent first circle intersection 200, and the needle of the polylactic acid suture thread is passed through the choke film 20
  • the intersection 103 is hooked from the inside to the outside, and then the line is crossed to an intersection 203 of the first circle intersection 200, and the intersection is hooked up from the outside to the outside of the intersection.
  • the counterclockwise cycle is routed for one week.
  • the two ends are knotted and knotted three times.
  • the knot can also be determined according to the size of the actual occluder. The number of times, there is no specific limit here. Make sure that the joint is not loose and complete the stitching of the baffle 20 on the occluder.
  • the choke film may be first stitched to the intersection of the first circle, and then the outermost.
  • the first circle intersection of adjacent stitched points in the circle intersection is sutured, and the direction of the needle can be clockwise or counterclockwise, such as the stitching method of the above embodiment, during the stitching process, the single section stitching
  • the number of points is reduced, but the total number of suture points of the choke membrane and the occluder is increased, and a joint fixation can be formed between the two sets of suture points, which increases the suturing strength of the choke membrane and the occluder, and further, It can ensure that the suture point of the occluder in the cross-section and the sheath is reduced, which reduces the possibility of displacement of the choke membrane under the squeeze friction of the sheath, and also strengthens the choke membrane and the plugging.
  • the stitching strength of the device is only one of many implementation methods.
  • an adjacent outermost loop intersection and a first loop intersection are bypassed between two adjacent suture points, in other implementations.
  • the number of the outermost circle crossing points and the number of the first ring intersections between the adjacent two stitching points can be determined, as long as the choke film can be ensured.
  • the stitching strength with the occluder disc structure can be used.

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Abstract

一种封堵器，包括具有网格的第一盘状结构（10），第一盘状结构（10）由至少两组编织线编织而成，两组编织线交叉形成多圈交叉点，第一盘状结构（10）内还设置有阻流膜（20），阻流膜（20）的边缘通过缝合线与多圈交叉点的最外圈交叉点（100）相连，且最外圈交叉点（100）中与阻流膜（20）缝合的交叉点的个数小于最外圈交叉点（100）中所有交叉点的个数，阻流膜（20）靠近其边缘的位置通过缝合线与多圈交叉点中的最外圈交叉点（100）内的一圈交叉点相连。该封堵器能够降低阻流膜（20）边缘不能抵到封堵器的盘面边缘的现象发生的可能性，提高了封堵器的封堵效果。

Description

封堵器及封堵器的缝合方法 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种封堵器及封堵器的缝合方法。
背景技术
心脏缺损封堵器是一种治疗先天性心脏缺损的植入型医疗器械，通常的结构主要包括密封盘、阻流膜、及缝合线等。阻流膜起到封堵缺损、阻隔血液分流的作用。阻流膜通过缝合线缝合的方式固定于密封盘的最大直径的边缘上。
目前市场上临床使用的封堵器大多是由镍钛合金丝编织而成。由于镍钛合金丝在人体内的长期存在易引起生物机体的排斥反应，以及由于镍离子的存在易引起过敏及相应并发症，甚至是一定程度的损伤，这些均会影响未发育成熟的患者心脏的发育成长。近年来出现一种由生物可降解材料(例如高分子材料)编织而成的可吸收的封堵器。可吸收封堵器在完成心脏封堵作用后，可分解成对人体无害的小分子，并且通过人体的代谢作用排除体外，避免人体长期受到异物影响。
然而，当该密封盘被收进鞘管时，由于该过程中鞘管口边缘对缝合线具有推挤作用，使密封盘网格上与缝合线缝合的交叉点向封堵器的远端移动，从而使阻流膜卷边。此外，当密封盘无外力作用时，由于在进入鞘管的过程中密封盘的网格交叉点向封堵器的远端移动且由高分子材料编织而成的密封盘的回弹性较由镍钛丝形成的密封盘的回弹性差，故，封堵器的密封盘的盘面的变大，进而导致封堵器释放后(即封堵器处于不受外力作用的自然状态下)，阻流膜边缘不能抵到封堵器的密封盘盘面的边缘，如此，患者缺损部位就会有残余分流血液，缺损部位无法完全被封堵，降低了手术的安全有效性。
发明内容
基于此，有必要提供一种在自然状态下能够降低阻流膜边缘不能抵到封堵器的盘面边缘的现象发生的可能性的封堵器。为解决上述问题，本发明所采用的技术方案是：
本发明提供了一种封堵器，包括具有网格的第一盘状结构，所述第一盘状结构由至少两组编织线编织而成，所述至少两组编织线交叉形成多圈交叉点，所述第一盘状结构内还设置有阻流膜，所述阻流膜的边缘通过缝合线与所述多圈交叉点的最外圈交叉点相连，且所述最外圈交叉点中与所述阻流膜缝合的交叉点的个数小于所述最外圈交叉点中所有交叉点的个数,所述阻流膜靠近其边缘的位置通过所述缝合线与所述多圈交叉点中的最外圈交叉点内的一圈交叉点相连。
在其中一个实施例中，所述阻流膜开设有第一圈缝合孔以及第二圈缝合孔，所述第一圈缝合孔较所述第二圈缝合孔远离所述阻流膜的中心，且所述第一圈缝合孔中缝合孔的个数小于所述最外圈交叉点中所有交叉点的个数。
在其中一个实施例中,所述第二圈缝合孔通过缝合线缝合于所述多圈交叉点中的距所述最外圈交叉点最近的一圈交叉点。
在其中一个实施例中，所述第一圈缝合孔设置在所述阻流膜的边缘。
在其中一个实施例中，所述第一圈缝合孔中的每两个缝合孔之间均有至少一个所述第二圈缝合孔中的一个缝合孔。
在其中一个实施例中，所述封堵器还包括与所述第一盘状结构相连的第二盘状结构以及连接于所述第一盘状结构与所述第二盘状结构之间的腰部。
在其中一个实施例中，所述第一盘状结构远端设置有远端封头，所述至少两组编织线的第一端收拢于所述远端封头；所述第二盘状结构的近端设置有近端封头，所述至少两组编织线的与所述第一端相对的第二端收拢于所述近端封头。
在其中一个实施例中，所述缝合线包括聚乳酸缝合线，所述阻流膜包括聚乳酸阻流膜。
在其中一个实施例中，所述封堵器为高分子材料封堵器。
在其中一个实施例中，所述封堵器由36根、72根或者144根编织线编织而成。
本发明还提供了一种封堵器的缝合方法，其特征在于，所述缝合方法包括：将所述阻流膜的边缘通过缝合线缝合于所述封堵器的多圈交叉点的最外圈交叉点，将所述阻流膜靠近边缘的位置通过所述缝合线缝合于所述多圈交叉点中的最外圈交叉点内的一圈交叉点。
在其中一个实施例中，所述阻流膜靠近边缘的位置通过所述缝线缝合于所述多圈交叉点中的距所述最外圈交叉点最近的一圈交叉点。
在其中一个实施例中，缝合完成后，将所述缝合线的两端进行打结。
与现有技术相比，本发明封堵器从鞘管中释放出来后，随着最外圈交叉点内的与阻流膜缝合的一圈交叉点向最外圈交叉点靠拢，与阻流膜缝合的最外圈交叉点内的一圈交叉点推动阻流膜的边缘移动，增加了阻流膜边缘抵到封堵器的盘状结构的盘面的边缘的可能性，即，降低了阻流膜边缘不能抵到封堵器的盘面边缘的现象发生的可能性,提高了患者缺损部位完全被封堵的可能性，提高了手术的安全有效性。
附图说明
图1为本发明一实施例提供的封堵器的结构示意图；
图2为图1中封堵器的局部缝合示意图；
图3为图2中的封堵器的阻流膜的结构示意图；
图4为本发明又一实施例提供的封堵器的结构示意图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术 领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
本发明的发明精神在于，将阻流膜的与封堵器的缝合点设置于封堵器的不同截面，使其从鞘管中释放出来后，随着最外圈交叉点内的与阻流膜缝合的一圈交叉点向最外圈交叉点靠拢，与阻流膜缝合的最外圈交叉点内的一圈交叉点推动阻流膜的边缘移动，增加了阻流膜边缘抵到封堵器的盘状结构的盘面的边缘的可能性，即降低了阻流膜边缘不能抵到封堵器的盘面边缘的现象发生的可能性,提高了患者缺损部位完全被封堵的可能性，提高了手术的安全有效性。此外，在收成束状拉进鞘管时，阻流膜和盘状结构的缝合点处于不同的截面上，从而能够减小封堵器截面的直径，减小进鞘时鞘管口对缝合线和阻流膜的阻力及挤推作用，同时由于同一截面缝合点的数量减少，大大减少了鞘管口对缝合线作用点数量，降低了封堵器收进鞘管时由于鞘管口推挤缝合点而使封堵器盘状结构上与缝合线缝合的交叉点向封堵器的远端发生位移的可能，进而可以有效地降低阻流膜卷边现象发生的可能，如此，不仅可以降低阻流膜在进入鞘管中时与交叉点断开的风险，还增大了自然状态下的封堵器完全封堵缺损的可能性。另外，阻流膜通过两圈交叉点与封堵器的盘状结构相缝合，两圈缝合点之间能够对阻流膜形成有效地固定，当封堵器进鞘时被拉伸成束状，两圈缝合点之间的缝合线能够拉扯两圈缝合点，从而降低了封堵器上与缝合线缝合的交叉点发生位移的可能，进而有效地降低了封堵器的盘状结构发生形变而导致盘面变大现象发生的可能，提高了封堵器的稳定性。其中，封堵器不限于高分子材料封堵器，也可以为其他材料(例如回弹性较镍钛合金丝差的金属材料)形成的封堵器，只要该封堵器的回弹性较镍钛合金丝制成的封堵器的回弹性差即可。封堵器的结构不限于单层封堵器，也可以为多层网盘结构的封堵器，阻流膜上的缝合点不限于两圈缝合点，也可以为三圈、四圈等根据实际需要的圈数的缝合点，以下以高分子材料封堵器为例说明本发明的封堵器。
请参阅图1以及图2，本实施例提出的一种封堵器1包括具有网格的第一盘状结构10及设于第一盘状结构10的阻流膜20。
第一盘状结构10可以由至少两组编织丝相互交错编织而成。带有网格的第一盘状结构10可以采用高分子材料编织制成。所述高分子材料可选自聚苯二甲酸乙二醇酯(PET：Polyethylene Terephthalate)、聚乳酸(PLA：Poly-L-lactide Acid)、聚乙醇酸(PGA：Poly-glycolide)、聚羟基脂肪酸脂(PHA：Poly-hydroxyalkanoate)、聚二氧环己酮(PDO：Poly-dioxanone)和聚己内酯(PCL：Poly-caprolactone)中的一种或者几种。本实施例中，第一盘状结构10由两组编织线相互交错编织形成。
第一盘状结构10中，两组编织线交叉形成有多圈交叉点，每圈交叉点均包括多个交叉点，同一圈交叉点的多个交叉点沿该圈的周向均匀分布(即相邻两个交叉点之间的沿该圈的周向的距离均相等)，每一个交叉点均由两组旋向不同的编织丝交叉而成。多圈交叉点包括封堵器1的最外圈交叉点100以及距最外圈交叉点100最近的第一圈交叉点200。多圈交叉点还包括第二圈交叉点、第三圈交叉点等，第二圈交叉点位于第一圈交叉点内环，第三圈交叉点位于第二圈交叉点内环，以此类推。
请一并参考图3，阻流膜20的形状以及尺寸根据第一盘状结构10的形状及尺寸来确定。本实施例中，阻流膜20为圆形，其直径等于第一盘状结构10的最大直径，以确保阻流膜20能够放入第一盘状结构10内的同时，也可与第一盘状结构10的边缘相抵触，进而使得阻流膜20能够将第一盘状结构10的最大截面处完全覆盖。
本实施例中，在阻流膜20边缘设置有第一圈缝合孔210以及第二圈缝合孔220，每一圈缝合孔中均包括多个缝合孔。第一圈缝合孔210设置在阻流膜20的边缘位置，且第一圈缝合孔210中的每相邻两个缝合孔之间的沿该圈周向的距离相等(即第一圈缝合孔210的多个缝合孔在该圈的周向向均匀分布)。第二圈缝合孔220设置于第一圈缝合孔210的内侧，且第二圈缝合孔220中的每相邻两个缝合孔之间的沿该圈周向的距离相等(即第二圈缝合孔220的多个缝合孔在该圈的周向向均匀分布)。第一圈缝合孔210中的每相邻两个缝合孔之间均有一个第二圈缝合孔220中的一个缝合孔。
可以理解的是，在其他实施例中，第一圈缝合孔210中的每相邻两个缝合 孔之间的沿该圈周向的距离也可以不相等，(即第一圈缝合孔210的多个缝合孔在该圈的周向向非均匀分布)，第二圈缝合孔220中的每相邻两个缝合孔之间的沿该圈周向的距离也可以不相等(即第二圈缝合孔220的多个缝合孔在该圈的周向向非均匀分布)，只要相邻两个第一圈缝合孔210之间有至少一个第二圈缝合孔220中的缝合孔即可。
优选地，第一圈缝合孔210中缝合孔的个数少于最外圈交叉点100中交叉点的个数。本实施例中，第一圈缝合孔210中缝合孔的个数为最外圈交叉点100中交叉点的个数的一半，在将阻流膜20缝合于第一盘状结构10时，第一圈缝合孔210中相邻两个第一圈缝合孔直接略过最外圈交叉点100中的一个交叉点，从而缝合后，最外圈交叉点100中一半的交叉点通过穿过第一圈缝合孔210中的缝合孔的缝合线与阻流膜20的边缘缝合，降低了第一盘状结构10最大直径的圆周上缝合点的数量，从而降低第一盘状结构10在束缚成束状后的径向长度。
阻流膜20边缘通过穿过第一圈缝合孔210的缝合线70缝合于最外圈交叉点100，阻流膜20靠近边缘的位置通过穿过第二圈缝合孔220的缝合线缝合于位于最外圈交叉点100内的一圈交叉点。从而当封堵器1在进鞘时，封堵器1被轴向拉长成为束状，阻流膜20也随之变形，由于阻流膜20上的缝合孔分别缝合于最外圈的交叉点100和最外圈的交叉点100内的一圈交叉点上，当封堵器1被轴向拉长成为束状时，阻流膜20的缝合点处于不同的截面上，在进鞘时，最外圈交叉点100所在的截面为封堵器1的最大截面，由于部分缝合点处于其他圈的交叉点上，因此在变形成束状后，封堵器1的最大截面面积因为缝合点的减少而减小，从而更加容易进鞘。再者，由于封堵器1的最大截面面积减小，鞘管口对封堵器1的摩擦与挤压也相应减少，同时由于最大截面上缝合点数量的减少，使得鞘管口对阻流膜20边缘的推挤作用点减少，从而减少了封堵器1的盘状结构因为缝合点受到挤压而发生的形变。此外，待阻流膜20与第一盘状结构10的最外圈交叉点100及最外圈交叉点100内的一圈交叉点缝合好之后，由于第一圈缝合孔210中的每相邻两个缝合孔之间均有一个第二圈缝合孔220中的一个缝合孔，故，当封堵器从鞘管中释放出来后，随着最外圈交叉点100内的与阻流膜20缝合的一圈交叉点向最外圈交叉点100靠拢，与阻流膜20缝 合的最外圈交叉点100内的一圈交叉点可以更加有效地推动最外圈交叉点100中与阻流膜100缝合的相邻的两个交叉点之间的阻流膜的边缘移动，进而使得阻流膜可以更加平整地收容于第一盘状结构10中，降低了自然状态下阻流膜20卷边的可能，提高了封堵的安全有效性。
进一步的，为达到更好的封堵效果，本实施例中，第二圈缝合孔缝合于封堵器的第一圈交叉点200上，第一圈交叉点200是最靠近所述最外圈交叉点100的一圈交叉点。
当阻流膜20在缝合后，由于阻流膜20自身具有一定的弹性，阻流膜20受到拉扯后，可以发生轻微的形变，但是由于第二圈缝合孔220距离第一圈缝合孔210较近，可以有效防止阻流膜发生塑性形变，从而能够降低阻流膜20在拉扯力的作用下破损的风险。
可以理解的是，在自然状态下(封堵器1未收成束状)，这里的第二圈交叉点200可以较最外圈交叉点100靠近封堵器1的远端，也可以较最外圈交叉点100靠近封堵器1的近端。
可以理解的是，其他实施例中，第一圈缝合孔210和/或第二圈缝合孔220可以省略不要，只要阻流膜20的边缘和阻流膜20靠近其边缘的位置可以通过缝合线分别与最外圈交叉点100及第一圈交叉点200上，且最外圈交叉点100中与阻流膜20缝合的交叉点的个数小于最外圈交叉点100中所有交叉点的个数即可。
本实施例中，阻流膜20通过缝合线70缝合于所述第一盘状结构10的交叉点上，所述缝合线70为聚乳酸缝合线70，所述阻流膜20为聚乳酸阻流膜。聚乳酸材料为可降解材料，能够被人体所吸收，可以理解的是，这里缝合线及阻流膜的材料也可以采用其他易于被人体吸收，对人身体无害的材料，这里不做具体的限定。
请参阅图4，本发明的另一实施例中，封堵器1a还包括第二盘状结构30a以及连接第一盘状结构10a与所述第二盘状结构30a的腰部60a，第二盘状结构30a与第一盘状结构10a具有相同的结构。进一步的，第一盘状结构10a与第二盘状结构30a通过腰部60a连通并形成“工”字型，在封堵心脏缺损时，第一 盘状结构10a与第二盘状结构30a分别用于与缺损房间隔两侧壁相抵持，以起到封堵心脏缺损的作用，可以理解的是，封堵器还可以为其他任意的形状，本实施例中封堵器的结构仅作举例，并不是对本发明结构的限制，本领域的普通技术人员可以在本发明的启示下选择任意适合的结构。
本实施例中，封堵器1a由两组编织线编织而成，第一盘状结构10a远端设置有远端封头40a，所述两组编织线的第一端收拢于远端封头40a；所述第二盘状结构30a的近端设置有近端封头50a，所述两组编织线的第二端收拢于所述近端封头50a。这里近端封头50a与远端封头40a的结构形状不做具体的限定，在本实施例中，近端封头50a与远端封头40a均设计为圆柱状结构。
在常规的封堵器中，编织线的数量一般为偶数，具体数量可以为36根、72根、144根等，这里不做具体的限定，在本实施例中，封堵器1a由36根编织线编织而成，因此所形成的最外圈交叉点的数量为18个，阻流膜与最外圈交叉点的缝合点的数量为9个，与第一圈交叉点的缝合点的数量为9个，极大地减少了封堵器1a进鞘时的截面面积。
下面结合附图对本发明的一个实施例的封堵器的阻流膜的缝合方法进行说明。
请一并参阅图2及图3，首先，根据封堵器1的上最外圈交叉点的数量确定阻流膜20上缝合点的数量及位置，使用镊子将裁减好的圆形聚乳酸阻流膜20通过预定型好的封堵器1的网格放进第一盘状结构10中；然后，用镊子将阻流膜20摊平，使其均匀的置于第一盘状结构10内，保证阻流膜20边缘与第一盘状结构10的盘面边缘相贴合；接着，选取盘面边缘相邻的最外圈交叉点100与第一圈交叉点200，将阻流膜20的边缘置于所选取的上下两圈交叉点之间，将穿好聚乳酸缝合线的针穿过阻流膜20边缘的第一圈缝合孔210，走线到最外圈交叉点的一个交叉点101，从该交叉点的内上方往外下方勾住此交叉点，然后走针到相邻的第一圈交叉点200的一个交叉点201，将穿好聚乳酸缝合线的针穿过阻流膜20边缘的第二圈缝合孔220，从外下方往内上方勾住此交叉点201，绕过两根编织丝，相当于空出最外圈交叉点100的一个交叉点102以及第一圈交叉点200的一个交叉点202，然后走针到最外圈交叉点100的一个交叉点103， 从内上方往外下方勾住交叉点103，然后走线到第一圈交叉点200的一个交叉点203，从该交叉点的外下方往内上方勾住此交叉点。如此逆时针循环走线一周，最外圈交叉点与第一圈交叉点各勾住9个交叉点后，将两线头打结，打结三次，也可以根据实际封堵器的大小决定打结的次数，这里不做具体的限定。确保接头不松脱，完成封堵器上阻流膜20的缝合。
需要说明的是，本实施例中给出的缝合方法只是众多实施方法的中的一种，例如在其他实施例中，也可以将阻流膜先与第一圈交叉点缝合，再与最外圈交叉点中相邻已缝合点的第一圈交叉点进行缝合，其走针方向可以是顺时针也可以是逆时针的方式，如上述实施例的缝合方法，缝合过程中，单一截面的缝合点的数量降低，但是阻流膜与封堵器缝合点的总体数量是增加的，且两组缝合点之间能够形成联合固定，增加了阻流膜与封堵器的缝合强度，进一步的，能够保证封堵器在进鞘时，截面上与鞘管作用的缝合点减少，降低了阻流膜在鞘口的挤压摩擦下发生移位的可能，同时还加强了阻流膜与封堵器的缝合强度。
上述实施例中，当对封堵器1进行阻流膜20的缝合时，相邻的两个缝合点之间，均绕过一个最外圈交叉点以及一个第一圈交叉点，在其他实施例中，也可以根据封堵器的大小及编织丝个数来确定相邻两个缝合点之间绕过的最外圈交叉点以及第一圈交叉点的个数，只要能够保证阻流膜与封堵器盘状结构的缝合强度即可。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (13)

  1. 一种封堵器，包括具有网格的第一盘状结构，所述第一盘状结构由至少两组编织线编织而成，所述至少两组编织线交叉形成多圈交叉点，所述第一盘状结构内还设置有阻流膜，其特征在于，所述阻流膜的边缘通过缝合线与所述多圈交叉点的最外圈交叉点相连，且所述最外圈交叉点中与所述阻流膜缝合的交叉点的个数小于所述最外圈交叉点中所有交叉点的个数,所述阻流膜靠近其边缘的位置通过所述缝合线与所述多圈交叉点中的最外圈交叉点内的一圈交叉点相连。
  2. 根据权利要求1所述的封堵器，其特征在于，所述阻流膜开设有第一圈缝合孔以及第二圈缝合孔，所述第一圈缝合孔较所述第二圈缝合孔远离所述阻流膜的中心，且所述第一圈缝合孔中缝合孔的个数小于所述最外圈交叉点中所有交叉点的个数。
  3. 根据权利要求2所述的封堵器，其特征在于，所述第二圈缝合孔通过缝合线缝合于所述多圈交叉点中的距所述最外圈交叉点最近的一圈交叉点。
  4. 根据权利要求2所述的封堵器，其特征在于，所述第一圈缝合孔设置在所述阻流膜的边缘。
  5. 根据权利要求2所述的封堵器，其特征在于，所述第一圈缝合孔中的每两个缝合孔之间均有至少一个所述第二圈缝合孔中的一个缝合孔。
  6. 根据权利要求1所述的封堵器，其特征在于，所述封堵器还包括与所述第一盘状结构相连的第二盘状结构以及连接于所述第一盘状结构与所述第二盘状结构之间的腰部。
  7. 根据权利要求6所述的封堵器，其特征在于，所述第一盘状结构远端设置有远端封头，所述至少两组编织线的第一端收拢于所述远端封头；所述第二盘状结构的近端设置有近端封头，所述至少两组编织线的与所述第一端相对的第二端收拢于所述近端封头。
  8. 根据权利要求1所述的封堵器，其特征在于，所述缝合线包括聚乳酸缝合线，所述阻流膜包括聚乳酸阻流膜。
  9. 根据权利要求1所述的封堵器，其特征在于，所述封堵器为高分子材料封堵器。
  10. 根据权利要求9所述的封堵器，其特征在于，所述封堵器由36根、72根或者144根编织线编织而成。
  11. 一种如权利要求1所述的封堵器的缝合方法，其特征在于，所述缝合方法包括：将所述阻流膜的边缘通过缝合线缝合于所述封堵器的多圈交叉点的最外圈交叉点，将所述阻流膜靠近边缘的位置通过所述缝合线缝合于所述多圈交叉点中的最外圈交叉点内的一圈交叉点。
  12. 根据权利要求11所述的封堵器的制作方法，其特征在于，所述阻流膜靠近边缘的位置通过所述缝线缝合于所述多圈交叉点中的距所述最外圈交叉点最近的一圈交叉点。
  13. 根据权利要求12所述的封堵器的制作方法，其特征在于，缝合完成后，将所述缝合线的两端进行打结。
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