WO2021121395A1 - 封堵器、封堵系统及封堵器中收紧件的打结方法 - Google Patents

封堵器、封堵系统及封堵器中收紧件的打结方法 Download PDF

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Publication number
WO2021121395A1
WO2021121395A1 PCT/CN2020/137639 CN2020137639W WO2021121395A1 WO 2021121395 A1 WO2021121395 A1 WO 2021121395A1 CN 2020137639 W CN2020137639 W CN 2020137639W WO 2021121395 A1 WO2021121395 A1 WO 2021121395A1
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WO
WIPO (PCT)
Prior art keywords
wire loop
section
wire
adjusting
locking
Prior art date
Application number
PCT/CN2020/137639
Other languages
English (en)
French (fr)
Inventor
王永胜
赵江浪
陈杰
Original Assignee
杭州诺茂医疗科技有限公司
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.)
Filing date
Publication date
Priority claimed from CN201922292918.9U external-priority patent/CN212165820U/zh
Priority claimed from CN201911313841.7A external-priority patent/CN112998769A/zh
Application filed by 杭州诺茂医疗科技有限公司 filed Critical 杭州诺茂医疗科技有限公司
Priority to EP20904197.9A priority Critical patent/EP4079232A4/en
Publication of WO2021121395A1 publication Critical patent/WO2021121395A1/zh
Priority to US17/843,648 priority patent/US20220346803A1/en

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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
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • 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
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • 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
    • A61B2017/00606—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
    • A61B2017/00619—Locking means for locking the implement in expanded state
    • 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
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0475—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery using sutures having a slip knot

Definitions

  • This application relates to the field of medical devices, and in particular to an occluder, a occlusion system, and a method for tying the waist of the occluder for blocking defects in the human body.
  • the occluder can block the foramen ovale, It can also be used to seal patent ductus arteriosus, atrial septal defect, ventricular septal defect, etc.
  • Patent Oval Foramen PFO
  • Patent foramen ovale means that the primary and secondary diaphragms of the fossa ovale are not completely fused, and there is a permanent gap-like defect in the middle, which leads to a deformity of the horizontal atrial shunt.
  • transcatheter interventional occluders have become an important method for minimally invasive treatment of congenital heart diseases such as patent foramen ovale, atrial septal defect, ventricular septal defect, and patent ductus arteriosus.
  • the transcatheter interventional occluder is a commonly used medical device in the transcatheter interventional treatment method. Because the patent foramen ovale is anatomically different from the atrial septal defect, it is necessary to seal the atrial septal defect on the basis of the device for sealing the atrial septal defect. The device with patent foramen ovale undergoes the necessary improvements.
  • the prior art patent foramen ovale occluder includes a double-disc sealing surface and a cylindrical waist perpendicular to the double-disc sealing surface.
  • the cylindrical waist squeezes and deforms the primary septum and the secondary septum.
  • the double-disc sealing surface clamps and fixes the deformed defect to block blood circulation.
  • the patent foramen ovale occluder in the prior art is only suitable for treating patent foramen ovale with a short overlap between the primary septum and the secondary septum, and it is difficult to treat the patent foramen ovale with a long overlap.
  • a large residual shunt is likely to occur between the primary diaphragm and the secondary diaphragm after treatment.
  • the blood flow rate will change, which can induce thrombosis. For this reason, the patient needs to prolong the resistance.
  • the formed thrombus if the formed thrombus enters the blood circulation, it can also cause serious adverse events such as embolism; and the distance between the double-disc sealing surfaces of the traditional occluder is fixed, and the waist cannot be adjusted according to the structure of the foramen ovale The distance makes the occluder conform to the anatomical structure of the foramen ovale.
  • the present application provides an occluder for occluding defects in the vasculature.
  • the occluder includes two occluding discs and a tightening member, and the two occluding discs are used to cover Different openings of the defect;
  • the tightening member includes a tightening line, the tightening line is used to pass through the defect, and connect the two sealing discs, between the two sealing discs The length of the tightening line can be adjusted through the free end of the tightening line.
  • the present application also provides an occlusion system, which includes an occluder and a conveyor.
  • the occluder is used to seal a defect in the vasculature.
  • the occluder includes: two occlusion discs and a tightening member, The two blocking discs are used to cover different openings of the defect; the tightening member includes a tightening wire, and the tightening wire is used to pass through the defect and connect the two blocking discs, The length of the tightening line between the two occluding discs can be adjusted through the free end of the tightening line; the conveyor is used to release the occluder.
  • the present application also provides a method for tying a tightening member in an occluder.
  • the tightening member is made by winding and knotting a tightening wire.
  • the tightening wire includes a locking section and a first section that are connected in sequence.
  • the second section and the adjustment section, the knotting method includes the following steps:
  • the two plugging discs of the plugging system provided by the present application respectively cover the periphery of different openings of the defect.
  • the distance between the two plugging discs can be controlled, which is beneficial to improve
  • the degree of fit between the two plugging discs and the surrounding tissues of the defect site can be used to stably block the defect. That is, after the occluder is implanted, the deformation of the defect site is ensured to be small, and the endothelialization of the plugging disc is not affected.
  • the generation of residual shunt avoids the need to customize the occluder due to the specific defect structure of individual patients, effectively expands the scope of application of the occluder, and enables more patients to benefit from minimally invasive surgery.
  • Fig. 1 is a schematic diagram of the structure of the blocking system provided by the first embodiment of the present application when released.
  • Fig. 2 is an enlarged view of the plugging system in Fig. 1.
  • Fig. 3 is an enlarged view of part III in Fig. 2.
  • Fig. 4 is a schematic diagram of one of the structures of the support skeleton of the occlusion device provided by the first embodiment of the present application.
  • Fig. 5 is a schematic diagram of another structure of the support skeleton of the occlusion device provided by the first embodiment of the present application.
  • Fig. 6 is a schematic view of the structure in which a flow blocking film is provided on the support frame in Fig. 5.
  • Fig. 7 is a schematic diagram of another structure of the support skeleton of the occlusion device provided by the first embodiment of the present application.
  • Fig. 8 is a schematic diagram of another structure of the support skeleton of the occlusion device provided by the first embodiment of the present application.
  • Fig. 9 is a schematic diagram of another structure of the support skeleton of the occlusion device provided by the first embodiment of the present application.
  • Fig. 10 is a schematic diagram of another structure of the support skeleton of the occlusion device provided by the first embodiment of the present application.
  • Figures 11-15 are schematic diagrams of the assembly process of the plugging disc and the tightening member of the occluder provided in the first embodiment of the present application.
  • Fig. 16 is a schematic diagram of the structure of the tightening member of the occlusion device provided by the second embodiment of the present application.
  • Figures 17-20 are schematic diagrams showing the knotting of the tightening line of the occlusion device provided in the second embodiment of the present application.
  • the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator;
  • the axial direction refers to the end parallel to the natural The direction of the connection between the distal center and the proximal center of the medical device in the state.
  • the present application provides an occlusion system 100, which includes an occluder 20 and a conveyor 50 for releasing the occluder 20.
  • the occluder 20 is used to seal the vasculature.
  • the defects include but not limited to foramen ovale, ductus arteriosus, atrial septal defect, ventricular septal defect, etc.
  • the defect is the foramen ovale 200 as an example to illustrate that the closure system 100 is used for treatment
  • the advantage of patent foramen ovale it is understandable that the defect can also be the other defects mentioned above.
  • the occluder 20 includes two occluding discs and a tightening member.
  • the two occluding discs are used to cover different openings of the foramen ovale 200, that is, the openings on both sides of the foramen ovale 200 in the left atrium and the right atrium; tightening
  • the piece includes a tightening thread 21, and is formed by winding and knotting the tightening thread 21.
  • the tightening wire 21 is used to pass through the oval hole 200 and connect the two plugging discs; the length of the tightening wire 21 between the two plugging discs can be adjusted by the free end of the tightening wire 21.
  • two occluding discs are respectively covered around the openings on the opposite sides of the foramen ovale 200, that is, the areas adjacent to the foramen ovale 200 on both sides of the primary diaphragm 301 and the secondary diaphragm 303 Both are covered by two blocking disks.
  • the distance between the two blocking disks can be controlled to adapt to the patient’s anatomical structure, which is beneficial to improve the relationship between the two blocking disks and the egg.
  • the fitting degree of the tissue around the circular hole 200 thus stably seals the foramen oval 200.
  • the occluder 20 After the occluder 20 is implanted, it is ensured that the deformation of the two diaphragms (primary diaphragm 301 and secondary diaphragm 303) is small, which does not affect the endothelialization of the two diaphragms to the occlusion disc, reduces the generation of residual shunt, and avoids Because of the specific structure of the foramen ovale 200 of individual patients, the trouble of customizing the occluder is effectively expanded, and more patients can benefit from minimally invasive surgery.
  • the occluder 20 is also used to seal multiple openings in the defect from both sides.
  • the two blocking disks are the first blocking disk 201 and the second blocking disk 205 respectively;
  • the tightening line 21 includes a wire knot 22 and a connecting section 23 connected to the wire knot 22, And the locking section 24 and the adjusting section 25 connected with the wire knot 22.
  • the connecting section 23 is connected between the first blocking disk 201 and the second blocking disk 205.
  • the connecting section 23 is connected to the geometric center of the first blocking disk 201, and/or the connecting section 23 is connected to the first blocking disk 201.
  • the geometric center of the second blocking disk 205 is
  • the locking section 24 includes a free end 241, and the adjusting section 25 includes a free end 251; the locking section 24, the adjusting section 25, and the knot 22 are all arranged on the side of the second blocking disk 205 away from the first blocking disk 201, and are connected
  • the length of the section 23 can be adjusted by the adjustment section 25.
  • the free end 241 of the locking section 24 and the free end 251 of the adjusting section 25 are connected to the conveyor 50.
  • the conveyor 50 is controlled to pull the free end 251 to realize the gap between the first blocking disc 201 and the second blocking disc 205.
  • the length of the connecting section 23 is adjusted to realize the adjustment of the distance between the two blocking disks; the free end 241 is controlled by the conveyor 50 to pull the free end 241 to achieve the locking of the wire knot 22 on the adjusting section 25, so that the first blocking disk 201 and The distance between the second occlusion disc 205 is relatively fixed to fix the distance between the first occlusion disc 201 and the second occlusion disc 205, which is beneficial to maintain the primary diaphragm 301 and the secondary diaphragm 303 during and after the operation.
  • the tightening member also includes a fixing wire 26 connected to the conveyor 50, and the conveyor 50 fixes one of the two blocking discs to the distal end of the conveyor 50 through the fixing wire 26.
  • a fixing wire 26 is connected to the second plugging disc 205, and the fixing wire 26 is used to fix the second plugging disc 205 at the distal end of the conveyor 50, so as to avoid pulling the adjusting section 25 and the locking section 24.
  • the two blocking discs are shaken at the same time to adjust the length of the connecting section 23 and lock the adjusting section 25 by the knot 22.
  • one end of the fixing wire 26 is connected to the middle of the second blocking disk 205, and the other end of the fixing wire 26 is fixed to the conveyor 50.
  • the first occlusion disk 201 is transported by the conveyor 50 to and deployed in the left atrium, and the second occlusion disk 205 is transported by the conveyor 50. 50 is delivered to and deployed in the right atrium.
  • the connecting section 23 connected between the first occluding disk 201 and the second occluding disk 205 is flexible and adjustable in length, and the connecting section 23 penetrates the foramen ova 200 between the primary diaphragm 301 and the secondary diaphragm 303 In; pull the adjustment section 25 proximally, the connecting section 23 is gradually shortened, that is, the distance between the first occlusion disk 201 and the second occlusion disk 205 gradually decreases, the primary diaphragm 301 and the secondary diaphragm 303 are close to each other and Clamped by the first occluding disk 201 and the second occluding disk 205, the first occluding disk 201 covers the primary diaphragm 301 and the secondary diaphragm 303 around the foramen ovale 200, and the second occluding disk 205 is in the egg
  • the periphery of the circular hole 200 covers the primary diaphragm 301 and the secondary di
  • both the first plugging disk 201 and the second plugging disk 205 include a support frame and a choke film arranged on the support frame.
  • the choke films on both sides of the oval hole 200 can prevent blood from flowing into the oval hole 200, thus avoiding the blood flow from the left atrium into the right atrium, so as to achieve immediate occlusion.
  • the primary diaphragm 301 and the secondary diaphragm 303 crawl to the contact position of the first occlusion disc 201 and the second occlusion disc 205 to close the foramen ovale 200 after endothelialization is completed , Forming a complete atrial septum.
  • the density of the supporting skeletons on the two blocking disks is sufficiently large, and the setting of the blocking membrane is omitted, which will not affect the endothelialization of the two diaphragms to the blocking disk, and there will be no diversion or diversion ratio on the foramen ovale channel.
  • the preset ratio may be 10%, %5, 3%, and so on.
  • the surface shape of the first plugging disc 201 and the second plugging disc 205 can be set to be circular, elliptical, triangular or other irregular shapes.
  • the radial area of the first plugging disc 201 and that of the second plugging disc 205 The radial area can be the same or different.
  • both the first plugging disk 201 and the second plugging disk 205 are substantially disc-shaped, and the radial area of the first plugging disk 201 is smaller than the radial area of the second plugging disk 205.
  • the first blocking disk 201 includes a first support frame 2011 and a first choke film 2013 disposed on the first support frame 2011.
  • the first choke film 2013 can be fixedly attached to the first support frame 2011.
  • the first baffle film 2013 may also be fixedly disposed in the inner cavity of the first support frame 2011, and the first baffle film 2013 covers at least the radial area of the first support frame 2011.
  • the tightening wire 21 is connected to the first supporting frame 2011 and/or the first blocking film 2013.
  • the connecting section 23 of the tightening wire 21 is slidably passed through the first supporting frame 2011.
  • the second blocking disk 205 includes a second supporting frame 2051 and a second blocking film 2053 disposed on the second supporting frame 2051.
  • the second blocking film 2053 can be fixedly attached to the inner surface and/or outer surface of the second supporting frame 2051.
  • the second baffle film 2053 can also be fixedly arranged in the inner cavity of the second support frame 2051, and the second baffle film 2053 covers at least the radial area of the second support frame 2051.
  • One end of the adjustment section 25 passes through the second choke film 2053 from the gap in the second support frame 2051 to connect the wire knot 22.
  • the first baffle film 2013 and the second baffle film 2053 can be selected as non-degradable polymer material films with good biocompatibility, such as ePTFE or PET; the first baffle film 2013 and the second baffle film 2053 can also be used Use absorbable polymer material film, such as polylactic acid, polycaprolactone, polylactic acid-caprolactone copolymer, etc.
  • the first baffle film 2013 and the second baffle film 2053 are fixed on the inner surface or outer surface of the blocking disc by suture or gluing, so as to block the blood flow.
  • the outer surface of the first blocking disk 201 is fixedly attached to the first flow blocking film 2013; the outer surface of the second blocking disk 205 is fixedly attached to the second blocking film 2053.
  • the first support frame 2011 and the second support frame 2051 are a woven mesh structure or a frame structure, so that the first occlusion disk 201 and the second occlusion disk 205 can fully adhere to the surface of the atrial septum.
  • the first support frame 2011 and the second support frame 2051 are respectively any one of a single-layer woven mesh structure, a single-layer frame structure, a double-layer network structure, or a double-layer frame structure; in this embodiment, the first support frame Both 2011 and the second support frame 2051 are single-layer woven mesh structures.
  • the woven net-like structure or the frame structure may have a petal-shaped structure, that is, the first support frame 2011 and the second support frame 2051 have a petal-shaped structure.
  • the petal-shaped structure is composed of a plurality of supporting screw rods, the plurality of supporting screw rods are arranged in a circular array along the center point of the woven mesh structure or the frame structure, and each of the supporting screw rods passes through the center point.
  • the first support frame 2011 and the second support frame 2051 can be made of various biocompatible materials, that is, each support screw can be made of various biocompatible materials, and various biocompatible materials are included in the The materials commonly used in the manufacture of released medical devices, such as memory alloy materials, preferably Nitinol; the first support frame 2011 and the second support frame 2051 can also be made of degradable materials, that is, each support screw It is made of degradable materials, such as polylactic acid PLA, polycaprolactone PCL, polyglycolide PGA or polydioxanone PDO, etc.; the supporting framework can also be polymerized by polymer Materials, etc.
  • peripheral edges of the first support frame 2011 are inclined and bent toward the second support frame 2051, and the peripheral edges of the second support frame 2051 are inclined and bent toward the first support frame 2011.
  • each support screw of the first support skeleton 2011 is away from the geometric center of the first support skeleton 2011 and is inclined and bent toward the second support skeleton 2051; each support screw of the second support skeleton 2051 is away from the second support skeleton
  • the geometric center of 2051 is inclined and bent toward the first support frame 2011.
  • the distance between the middle of the first occluding disk 201 and the second occluding disk 205 is greater than the distance between the peripheral edges The distance makes the first occlusion disk 201 and the second occlusion disk 205 more firmly clamp the primary diaphragm 301 and the secondary diaphragm 303 around the foramen ovale.
  • the first plugging disk 201 further includes a first steel sleeve 2015 arranged in its central area.
  • the first steel sleeve 2015 is arranged on the geometrical shape of the first plugging disk 201.
  • the support screw 2012 of the first plugging disk 201 is connected to the first steel sleeve 2015 and surrounds the first steel sleeve 2015 to form a first support frame 2011.
  • the first steel sleeve 2015 is tubular, and the first steel sleeve 2015 is provided with a through hole extending along the thickness direction of the first plugging disk 2011 (the direction perpendicular to the surface of the first plugging disk 201), and a plurality of free supports for the screw rods 2012
  • the end is fixedly arranged on the outer peripheral surface or the inner peripheral surface of the first steel sleeve 2015.
  • the free ends of a plurality of supporting screw rods 2012 are accommodated in the inner cavity of the first steel sleeve 2015, and are fixedly connected to the first steel sleeve 2015 by welding or bonding.
  • the material of the first steel sleeve 2015 is stainless steel, Nitinol or other biocompatible materials.
  • the second plugging disk 205 also includes a second steel sleeve 2055 arranged in the central area thereof, and the second steel sleeve 2055 is connected to the second support frame 2051.
  • the second steel sleeve 2055 is fixedly arranged on the second plugging disk 205
  • the second steel sleeve 2055 is tubular.
  • the second steel sleeve 2055 is provided with a threading hole 2056 along the thickness direction of the second support frame 2051. One end of the connecting section 23 passes through the threading hole 2056 to connect the thread knot 22.
  • the free ends of a plurality of supporting screw rods are fixedly arranged on the outer peripheral surface or the inner peripheral surface of the second steel sleeve 2055.
  • the free ends of several supporting screws are fixedly connected to the outer peripheral surface of the second steel sleeve 2055 by welding or bonding.
  • the material of the second steel sleeve 2055 is stainless steel, nickel-titanium alloy or other biocompatible materials. material.
  • first steel sleeve 2015 may also be disposed in the non-central area of the first plugging disk 201; the second steel sleeve 2055 may also be disposed in the non-central area of the second plugging disk 205.
  • the first support frame 2011 and the second support frame 2051 are generally woven from 4-50 support screws, and meshes are formed between adjacent support screws.
  • the following technical solutions are also applicable to the second support frame 2051:
  • the first support frame 2011 in FIG. 4 is formed by an annular array of 30 circular support screws 2012.
  • the first support frame 2011 in Fig. 5 and Fig. 6 is formed by an annular array of 6 circular support screws 2012, and the first support frame 2011 in Fig. 6 is provided with a first flow blocking film 2013.
  • each of the supporting screw rods may be elliptical, semicircular, prismatic, or irregular in shape.
  • the first support frame 2011a consists of a number of elliptical support screws 2012 in a circular array along the center point of the support frame 2012a. One of the top ends of each support screw 2012 passes through the center point, and the first support The inner surface and/or outer surface of the frame 2011a is provided with the flow blocking film.
  • the first support frame 2011b consists of a plurality of semicircular support screws 2012 in an annular array along the center point of the first support frame 2011b, and one of the arc end points of each support screw 2012 passes through the center.
  • the inner surface and/or outer surface of the first support frame 2011b is provided with the choke film.
  • the first support frame 2011c consists of a plurality of prismatic support screws 2012 in an annular array along the center point of the first support frame 2011c, and one of the top ends of each support screw 2012 passes through the center point;
  • the inner surface and/or outer surface of a supporting frame 2011c is provided with the flow blocking film.
  • the first support frame 2011d consists of a number of irregularly shaped support screws 2012 along the center point of the first support frame 2011d in an annular array, and one of the top ends of each support screw 2012 passes through the center point;
  • the inner surface and/or outer surface of the first support frame 2011d is provided with the flow blocking film.
  • each of the supporting screw rods may be triangular, polygonal, or the like.
  • the tightening thread 21 can optionally be a non-absorbable biocompatible suture, such as metal thread, cotton thread, polyester, polypropylene, etc., and the tightening thread 21 can also be an absorbable biocompatible suture, such as catgut, For polyglycolide, multifilament non-biodegradable suture thread, etc., the tightening thread 21 can also be a forced winding fiber thread.
  • a non-absorbable biocompatible suture such as metal thread, cotton thread, polyester, polypropylene, etc.
  • the tightening thread 21 can also be an absorbable biocompatible suture, such as catgut, For polyglycolide, multifilament non-biodegradable suture thread, etc.
  • the tightening thread 21 can also be a forced winding fiber thread.
  • the locking section 24 and the adjusting section 25 are respectively located at two ends of the connecting section 23, and the knot 22 is located between the connecting section 23 and the locking section 24.
  • the connecting section 23 is an adjusting wire loop 230 surrounded by the tightening line 21 into an inverted U shape. Both ends of the adjusting wire loop 230 pass through the second blocking disk 205 to connect the wire knot 22. The portion of the adjusting wire loop 230 away from the wire knot 22 can be It is slidably inserted into the first blocking disk 201.
  • the part of the adjusting wire loop 230 away from the knot 22 and the adjusting section 25 is slidably inserted into the geometric center of the first plugging disc 201, and the two ends of the adjusting wire loop 230 are respectively along the thickness of the second plugging disc 205.
  • the direction passes through the geometric center of the second plugging disc 205, so that the forces of the first plugging disc 201 and the second plugging disc 205 are more uniform.
  • the part of the adjusting wire loop 230 away from the knot 22 and the adjusting section 25 is inserted into the first plugging disk 201, and both ends of the adjusting wire loop 230 respectively pass through the mesh at the geometric center of the second plugging disk 205.
  • the two ends of the adjusting wire loop 230 respectively pass through different meshes on the second blocking disk 205 to facilitate the connection of different components on the conveyor 50.
  • the position through which the adjusting section 25 and the locking section 24 pass is located at the geometric center of the first plugging disc 201 and the second plugging disc 205, which is conducive to pulling
  • the tightening line 21 is tightened, the pulling force is applied to the geometric center of the blocking disk, and the blocking disk is uniformly stressed, which is convenient for manipulation.
  • a plurality of positions on the first blocking disk 201 connecting the connecting section 23 are close to each other, and/or a plurality of positions on the second blocking disk 205 connecting the connecting section 23 are close to each other; specifically, the first sealing disk 205 is close to each other.
  • the positions of the two mesh holes of the connecting section 23 on the plugging disk 201 are close to each other; on the second plugging disk 205, one end of the connecting section 23 is pierced through the threading hole 2056 of the second steel sleeve 2055, and the connecting section 23 The mesh through the other end is close to the threading hole 2056.
  • the position span of the choke film on the second plugging disk 205 is relatively large, the perforation on the choke film for penetrating the connecting section 23 is easily connected.
  • the section 23 is pulled obliquely to cause the perforation to become larger and larger, which affects the flow blocking effect of the choke membrane; if the perforation of the connecting section 23 is too large, the perforation position will not be endothelialized subsequently, resulting in the closure of the oval foramen The effect is not good.
  • the connecting section 23 gathers at the perforation positions on the two discs, which prevents the perforation on the baffle film from being pulled by the connecting section 23 and causes the perforation to become larger and larger, which is beneficial to maintain the integrity of the baffle film for a long time and ensures the operation
  • One end of the adjusting wire loop 230 is connected to the wire knot 22, and the other end of the adjusting wire loop 230 is inserted into the wire knot 22 and connected to the adjusting section 25.
  • the adjustment section 25 can drive one end of the adjustment wire loop 230 connected to it to slide in the knot 22 to adjust the adjustment wire between the first plugging disc 201 and the second plugging disc 205
  • the length of the ring 230; the locking section 24 is used to tighten the knot 22, so that the knot 22 tightens a part of the adjustment wire ring 230 located therein to fix the first occluding disc 201 and the second occluding disc 205
  • the length of the adjustment wire loop 230 is used to tighten the knot 22, so that the knot 22 tightens a part of the adjustment wire ring 230 located therein to fix the first occluding disc 201 and the second occluding disc 205.
  • the wire knot 22 includes a basic wire ring 221 and a locking wire ring 223 that are connected to each other.
  • One end of the adjusting wire ring 230 is connected to the basic wire ring 221, and the other end of the adjusting wire ring 230 passes through the locking wire ring 223.
  • the adjustment section 25 can drive one end of the adjustment wire loop 230 connected to it to slide in the locking wire ring 223 to adjust the first seal
  • the tightening line 21 includes a first section 211 (as shown in FIG. 11) connected with the locking section 24, and a second section 213 (as shown in FIG. 11) connected with the adjusting section 25, the first section 211 Connected to the second section 213; the basic wire loop 221 is surrounded by the first section 211, and the locking wire loop 223 is formed by the remaining part of the first section 211 passing through the basic wire loop 221
  • the second section 213 encloses an adjustment wire loop 230.
  • the side between the first plugging disc 201 and the second plugging disc 205 is the inside, the side of the first plugging disc 201 facing away from the second plugging disc 205, and the second plugging disc 205 facing away
  • One side of the first sealing disc 201 is the outer side.
  • the two ends of the adjusting wire loop 230 pass through the second closing disk 205 from the inner side of the second closing disk 205 to the outside thereof, and the end of the adjusting wire loop 230 away from the knot 22 passes through the inner side of the first closing disk 201.
  • one end of the tightening line 21 passes through different meshes of the first plugging disk 201, for example, after two radially spaced meshes at the inner geometric center of the first plugging disk 201, it is folded back To the inner side of the first blocking disc 201, that is, close to the other end of the tightening line 21, the part of the tightening line 21 away from the end is slidably inserted on the first blocking disc 201.
  • the tightening line 21 forms an inverted U shape, and the first section 211 and the second section 213 of the tightening line 21 are respectively located on both sides of the axial centerline of the first blocking disk 201, and the first section
  • the end of 211 away from the first blocking disk 201 is connected to the locking section 24, and the end of the second section 213 away from the first blocking disk 201 is connected to the adjusting section 25.
  • the tightening line 21 is provided with a knot 22 formed by winding the first section 211 and the second section 213 on the outside of the second blocking disk 205.
  • the knot 22 can lock
  • the section 24 and the adjusting section 25 are locked and abutted on the outside of the second blocking disc 205 to position and adjust the length of the wire loop 230.
  • the knotting method of the knot 22 formed by winding the first section 211 is described in detail:
  • the blocking system 100 of the present application needs to be used in conjunction with a guide wire, a conveyor 50, a dilator, etc. during use.
  • the procedure is as follows:
  • One end of 25 is tightened and locked by the locking wire ring 223, and is fixed between the locking wire ring 223 and the basic wire ring 221, that is, the basic wire ring 221 and the locking wire ring 223 together lock the adjusting wire ring 230.
  • the length of the wire loop 230 between the first occlusion disk 201 and the second occlusion disk 205 is fixed, so that the first occlusion disk 201 and the second occlusion disk 205 clamp the atrial septum.
  • the released structure of the occlusion device provided by the second embodiment of the present application is similar to the structure of the first embodiment, except that the tightening line 21a of the occlusion device in the second embodiment
  • the structure of the knot 22a is slightly different from the structure of the wire knot 22 in the first embodiment, and the reinforcing wire loop 226 is added to the structure 22 of the first embodiment of the wire knot 22a.
  • One end of the reinforcing wire loop 226 is connected to the basic wire loop 221, and the other end of the reinforcing wire loop 226 passes through the gap between the basic wire loop 221 and the locking wire loop 223 to connect to the adjusting wire loop 230.
  • the basic wire loop 221 After the locking section 24 is tightened, in the process of tightening the basic wire loop 221 and the locking wire loop 223, in addition to the locking wire loop 223 tightening the adjusting section 25, the basic wire loop 221 also tightens the reinforcing wire loop 226 Therefore, the ability of the locking wire loop 223 to lock the adjusting section 25 is enhanced.
  • the knotting method of the thread knot 22a is similar to the knotting method of the thread knot 22, and the details are as follows:
  • the basic wire loop 221 of the tightening member 21a partially overlaps the locking wire loop 223, and the orientation of the first direction and the second direction may be one of the following two situations:
  • the first direction is from the side of the locking wire loop 223 to the side of the base wire loop 221, such as the direction perpendicular to the paper surface in FIG. 19.
  • the first direction is from the side of the base thread loop 221 to the side of the locking thread loop 223, such as the direction perpendicular to the paper surface in FIG. 19.
  • the method of assembling the tightening line 21a with the first plugging disc 201 and the second plugging disc 205 in the second embodiment is similar to that of the first embodiment, that is, before the knotting of the wire knot 22a, the tightening wire 21a
  • One end passes through the mesh of the first plugging disc 201, and then folds back to the other end of the first plugging disc 201 close to the tightening line 21a, so that the tightening line 21a is located inside the first plugging disc 201; Pass one end of the tightening wire 21a through the threading hole 2056 of the second steel sleeve 2055 from the inside to the outside of the second blocking disk 205, and the other end of the tightening wire 21a from the inside of the second blocking disk 205 to the outside.
  • the outside passes through the meshes close to the second steel sleeve 2055, so that the two ends of the tightening line 21a are juxtaposed on the outside of the second blocking disk 205, and the tightening line 21a is located between the first blocking disk 201 and the second blocking disk 205.
  • the part in between forms the adjusting wire loop 230; then, the knotting method of the wire knot 22a can be performed.
  • the use process of the plugging system in the second embodiment is the same as the use process of the plugging system in the first embodiment, and will not be described here.
  • the locking section 24 and the adjusting section 25 can also be inserted or wound multiple times around the adjusting wire loop 230 and the locking wire loop 223, so as not to hinder the realization of the length adjustment and the locking function.
  • the knot 22 can also adopt other knotting methods, that is, it is arranged on the first blocking disk 201 and the second blocking disk 205, which can adjust the length of the connecting section 23 and can be locked. 22 can be.
  • the first plugging disc 201 and the second plugging disc 205 omit the first steel sleeve 2015 and the second steel sleeve 2055, and the tightening line 21 passes through the first plugging disc 201 and the second plugging disc 201 and the second steel sleeve 2055.
  • the mesh of the plugging disc 205 is connected to the first plugging disc 201 and the second plugging disc 205.
  • first plugging disk 201 and the second plugging disk 205 may be single-layer mesh disks and double-layer mesh disks, respectively.
  • a gasket is added on the basis of the first embodiment. Specifically, a gasket is provided at the geometric center of the outer side of the second plugging disc 205, and the gasket is arranged along the second plugging disc 205. Two spaced through holes are opened in the thickness direction of the, as shown in Figure 2, one of the through holes corresponds to the threading hole 2056 of the second steel sleeve 2055, so that one end of the adjusting wire loop 230 can pass through; the other through hole corresponds to the adjusting wire The other end of the loop 23 is convenient for the other end of the adjustment wire loop 23 to pass through.
  • the knot 22, the locking section 24 and the adjusting section 25 are all located on the side of the gasket away from the second blocking disc 205.
  • the gasket can make the outside force of the second plugging disc 205 more uniform, so that the clamping force between the first plugging disc 201 and the second plugging disc 205 is more uniform, so that the closed seal Blocking is more stable.

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Abstract

一种封堵器（20），用于封堵脉管系统中的缺损，封堵器（20）包括：两封堵盘及收紧件，两封堵盘用于覆盖缺损的不同开口；收紧件包括收紧线（21），收紧线（21）用于穿置于缺损中，并连接两封堵盘，两封堵盘之间的收紧线（21）的长度能够通过收紧线（21）的自由端调节。还提供一种设置封堵器（20）的封堵系统（100）及封堵器（20）中收紧件的打结方法。

Description

封堵器、封堵系统及封堵器中收紧件的打结方法 技术领域
本申请涉及医疗器械领域，尤其涉及一种用于封堵人体内缺损的封堵器、封堵系统，以及该封堵器腰部的打结方法，所述封堵器可封堵卵圆孔，也可用于封堵动脉导管未闭、房间隔缺损、室间隔缺损等。
背景技术
卵圆孔一般在胎儿出生后第1年闭合，若大于3岁的幼儿卵圆孔仍不闭合称卵圆孔未闭(Patent Oval Foramen，PFO)，成年人中有20％～25％的卵圆孔不完全闭合。卵圆孔未闭是指卵圆窝部的原发膈与继发膈未完全融合，中间存在一个永久性的裂隙样缺损，从而导致心房水平分流的一种畸形。
随着科技的进步，尤其是导管技术的发展，经导管介入封堵器成为微创治疗卵圆孔未闭、房间隔缺损、室间隔缺损以及动脉导管未闭等先天性心脏病的重要方法。经导管介入封堵器是经导管介入治疗方法中常用的医疗器械，由于卵圆孔未闭与房间隔缺损在解剖上有所不同，需要在封堵房间隔缺损装置的基础上，对封堵卵圆孔未闭的装置进行必要的改进。现有技术中的卵圆孔未闭封堵器包括双盘封堵面和一个与所述双盘封堵面垂直的圆柱细腰组成，圆柱细腰将原发隔与继发隔挤压变形，双盘封堵面对变形后的缺损夹合固定以阻挡血液流通。
然而，现有技术中的卵圆孔未闭封堵器只适合治疗原发隔与继发隔交叠较短的卵圆孔未闭，对于交叠较长的卵圆孔未闭很难起到封堵器效果，治疗后原发膈与继发膈之间容易产生较大的残余分流，血液流过卵圆孔时将引发血液流速的改变，可诱发血栓形成，为此患者需延长抗凝治疗的时间，若形成的血栓进入血液循环，还可造成栓塞等严重的不良事件；并且，传统封堵器的双盘封堵面之间的距离固定，无法根据卵圆孔的结构调节腰部的距离，使封堵器顺应卵圆孔的解剖结构。
发明内容
有鉴于此，本申请提供了一种封堵器，用于封堵脉管系统中的缺损，所述封堵器包括：两封堵盘及收紧件，所述两封堵盘用于覆盖所述缺损的不同开口；所述收紧件包括收紧线，所述收紧线用于穿置于所述缺损中，并连接所述两封堵盘，所述两封堵盘之间的收紧线的长度能够通过所述收紧线的自由端调节。
本申请还提供一种封堵系统，其包括封堵器及输送器，所述封堵器用于封堵脉管系统中的缺损，所述封堵器包括：两封堵盘及收紧件，所述两封堵盘用于覆盖所述缺损的不同开口；所述收紧件包括收紧线，所述收紧线用于穿置于所述缺损中，并连接所述两封堵盘，所述两封堵盘之间的收紧线的长度能够通过所述收紧线的自由端调节；所述输送器用于释放所述封堵器。
本申请还提供一种封堵器中收紧件的打结方法，所述收紧件由收紧线缠绕打结制成，所述收紧线包括依次连接的锁紧段、第一区段、第二区段以及调节段，所述打结方法包括以下步骤：
将所述第一区段围成一线圈得到基础线环；
将所述第一区段中的剩余部分从所述基础线环中穿出得到锁紧线环；
将所述调节段穿过所述锁紧线环，使得所述第二区段在所述封堵器的两封堵盘之间形成调节线环，从而得到所述收紧件。
本申请提供的封堵系统的两封堵盘分别覆盖于缺损不同开口的周围，通过调节两封堵盘之间的收紧线的长度，以控制两封堵盘之间的距离，有利于提高两封堵盘与缺损部位周边组织的贴合程度，从而稳定地封堵所述缺损，即植入封堵器后，确保了缺损部位的变形程度较小，不影响封堵盘内皮化，减少残余分流的产生，避免了由于个别患者的缺损结构特异而需要定制封堵器的麻烦，有效拓展了封堵器的适用范围，使更多的患者从微创手术中获益。
附图说明
为了更清楚地说明本申请实施例的技术方案，下面将对实施方式中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本申请一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是本申请第一实施例提供的封堵系统释放时的结构示意图。
图2是图1中的封堵系统的放大图。
图3是图2中III部分的放大图。
图4是本申请第一实施例提供的封堵器的支撑骨架其中一结构的示意图。
图5是本申请第一实施例提供的封堵器的支撑骨架的另一结构的示意图。
图6是图5中的支撑骨架上设置有阻流膜的结构示意图。
图7是本申请第一实施例提供的封堵器的支撑骨架的另一结构的示意图。
图8是本申请第一实施例提供的封堵器的支撑骨架的另一结构的示意图。
图9是本申请第一实施例提供的封堵器的支撑骨架的另一结构的示意图。
图10是本申请第一实施例提供的封堵器的支撑骨架的另一结构的示意图。
图11-图15是本申请第一实施例提供的封堵器的封堵盘与收紧件的组装过程示意图。
图16是本申请第二实施例提供的封堵器的收紧件的结构示意图。
图17-图20是本申请第二实施例提供的封堵器的收紧线的打结过示意图。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其他实 施例，都属于本申请保护的范围。
在本申请的描述中，需要说明的是，术语“上”、“下”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或者暗示所指的装置或者元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”等仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本申请的描述中，需要说明的是，在介入医疗器械领域，近端是指距离操作者较近的一端，而远端是指距离操作者较远的一端；轴向是指平行于自然状态下的医疗器械远端中心和近端中心连线的方向。上述定义只是为了表述方便，并不能理解为对本申请的限制。
请一并参阅图1至图3，本申请提供一种封堵系统100，其包括封堵器20及用于释放封堵器20的输送器50，封堵器20用于封堵脉管系统中的缺损，所述缺损包括但不限于卵圆孔、动脉导管、房间隔缺损、室间隔缺损等，本申请中以所述缺损为卵圆孔200为例，说明封堵系统100用于治疗卵圆孔未闭的优势，可以理解的是，所述缺损还可以是上述提到的其他缺损。
封堵器20包括两封堵盘及收紧件，所述两封堵盘用于覆盖卵圆孔200的不同开口，即卵圆孔200位于左心房以及右心房中的两侧开口；收紧件包括收紧线21，并由收紧线21缠绕打结形成。收紧线21用于穿置于卵圆孔200中，并连接所述两封堵盘；两封堵盘之间的收紧线21的长度能够通过收紧线21的自由端调节。
本申请的封堵系统100植入人体后，两封堵盘分别覆盖于卵圆孔200相对两侧开口的周围，即原发膈301与继发膈303两侧面上邻近卵圆孔200的区域均被两封堵盘覆盖，通过调节两封堵盘之间的收紧线21的长度，以控制两封堵盘之间的距离，以适应患者解剖结构，有利于提高两封堵盘与卵圆孔200周围的组织的贴合程度从而稳定地封堵卵圆孔200。在植入封堵器20后，确保了两膈膜(原发膈301与继发膈303)的变形程度较小，不影响两膈膜向封堵盘内皮化，减少残余分流的产生，避免了由于个别患者的卵圆孔200结构特异而需要定制封堵器的麻烦，有效拓展了PFO封堵器的适用范围，使更多的患者从微创手术中获益。
在缺损存在2个以上的开口的实施例中，封堵器20还用于从两侧封堵缺损中的多个开口。
如图2及图3所示，所述两封堵盘分别为第一封堵盘201与第二封堵盘205；收紧线21包括线结22、与线结22连接的连接段23，以及与线结22连接的锁紧段24与调节段25。其中，连接段23连接在第一封堵盘201与第二封堵盘205之间，优选地，连接段23连接于第一封堵盘201的几何中心，及/或连接段23连接于第二封堵盘205的几何中心。锁紧段24包括自由端241，调节段25包括自由端251；锁紧段24、调节段25与线结22均设置于第二封堵盘205背离第一封堵盘201的一侧，连接段23的长度能够通过调节段25调节。锁紧段24的自由端241及调节段25的自由端251连接于输送器50上，通过控制输送器50拉动自由端251以实现对第一封堵盘201与第二封堵盘205之间的连接段23的长度 的调节，从而实现调节两封堵盘之间的距离；通过控制输送器50拉动自由端241以实现线结22对调节段25的锁定，使得第一封堵盘201与第二封堵盘205之间的距离相对固定，以固定第一封堵盘201与第二封堵盘205之间的距离，有利于术中以及术后保持原发膈301、继发膈303、以及两封堵盘的相对位置与贴近状态，从而降低了输送器50的回撤难度，有利于术后两膈膜向封堵器20生长完成内皮化形成永久性房间隔。
如图2所示，由于调节段25与锁紧段24都是连接在封堵盘上的活动线，单独操作调节段25与锁紧段24会引起封堵盘移动，可操作性不佳；因此，收紧件还包括连接输送器50的固定线26，输送器50通过固定线26将两封堵盘中的一个固定于输送器50的远端。具体地，第二封堵盘205上连接有固定线26，固定线26用于将第二封堵盘205固定在输送器50的远端，从而避免拉动调节段25与锁紧段24时两个封堵盘同时晃动，以便对连接段23的长度进行调节以及线结22对调节段25的锁定。本实施例中，固定线26的一端连接于第二封堵盘205的中部，固定线26的另一端固定在输送器50。
如图1所示，本实施例中，在使用的过程中，第一封堵盘201被输送器50输送至从左心房并在所述左心房中展开，第二封堵盘205被输送器50输送至右心房并在右心房中展开。连接于第一封堵盘201与第二封堵盘205之间的连接段23具有柔性且长度可以调节，连接段23穿设在原发膈301与继发膈303之间的卵圆孔200中；向近端拉动调节段25，使连接段23逐渐缩短，即第一封堵盘201与第二封堵盘205之间的距离逐渐缩小，原发膈301与继发膈303相互靠近并被第一封堵盘201和第二封堵盘205夹持，第一封堵盘201在卵圆孔200的周围覆盖原发膈301与继发膈303，并且第二封堵盘205在卵圆孔200的周围覆盖原发膈301与继发膈303，即卵圆孔200在左右心房中的两侧开口分别被第一封堵盘201与第二封堵盘205覆盖。本实施例中，第一封堵盘201及第二封堵盘205均包括支撑骨架以及设置于支撑骨架上的阻流膜，卵圆孔200两侧的阻流膜能阻止血液流入卵圆孔200，从而避免了血流从左心房流入右心房，以实现即时封堵。在封堵器20植入人体后，原发膈301与继发膈303向第一封堵盘201及第二封堵盘205的接触位置爬附，以完成内皮化后使卵圆孔200闭合，形成完整的房间隔。在变更实施例中，两封堵盘上的支撑骨架密度足够大，并省略设置阻流膜，不会影响两膈膜向封堵盘内皮化，卵圆孔通道上不会形成分流或分流较小，比如在一预设比例以下，预设比例可以是10％、％5、3％等等。
第一封堵盘201及第二封堵盘205的盘面形状可以设置为圆形、椭圆形、三角形或者其他不规则形状，第一封堵盘201的径向面积与第二封堵盘205的径向面积可以相同，也可以不同。本实施例中，第一封堵盘201及第二封堵盘205均呈大致圆盘状，第一封堵盘201的径向面积小于第二封堵盘205的径向面积。
具体地，如图2所示，第一封堵盘201包括第一支撑骨架2011及设置于第一支撑骨架2011的第一阻流膜2013，第一阻流膜2013可以固定贴合于第一支撑骨架2011内表面和/或外表面，第一阻流膜2013也可以固定设置于第一支撑骨架2011的内腔，第一阻流膜2013至少覆盖第一支撑骨架2011的径向区域。收紧线21连接第一支撑骨架2011及/或第一阻流膜2013，本实施例中，收紧线21的连接段23可滑动地穿设于第一支撑骨架2011上。
第二封堵盘205包括第二支撑骨架2051及设置于第二支撑骨架2051的第二阻流膜2053，第二阻流膜2053可以固定贴合于第二支撑骨架2051内表面和/或外表面，第二阻流膜2053也可以固定设置于第二支撑骨架2051的内腔，第二阻流膜2053至少覆盖第二支撑骨架2051的径向区域。调节段25的一端从第二支撑骨架2051中的缝隙穿过第二阻流膜2053以连接线结22。
第一阻流膜2013及第二阻流膜2053可选用为生物相容性好的不可降解聚合物材料膜，如ePTFE或PET材料；第一阻流膜2013及第二阻流膜2053也可以选用可吸收的聚合物材料膜，如聚乳酸、聚己内酯、聚乳酸-己内酯共聚物等。第一阻流膜2013及第二阻流膜2053通过缝合或者胶粘的方式固定于封堵盘的内表面或者外表面，用于封堵血流。本实施例中，第一封堵盘201的外表面固定贴合有第一阻流膜2013；第二封堵盘205的外表面固定贴合有第二阻流膜2053。
第一支撑骨架2011及第二支撑骨架2051为编织网状结构或者框架结构，使得第一封堵盘201及第二封堵盘205能充分与心房间隔的表面贴合。第一支撑骨架2011与第二支撑骨架2051分别为单层编织网状结构、单层框架结构、双层网状结构或者双层框架结构中的任意一种；本实施例中，第一支撑骨架2011与第二支撑骨架2051均为单层编织网状结构。
所述编织网状结构或者框架结构可以呈花瓣形结构，即，第一支撑骨架2011及第二支撑骨架2051呈花瓣形结构。所述花瓣形结构由若干支撑丝杆构成，所述若干支撑丝杆沿所述编织网状结构或者框架结构的中心点按照环形阵列排布，且每一个所述支撑丝杆穿过所述中心点。第一支撑骨架2011及第二支撑骨架2051可由各种生物相容的材料制成，即，每一支撑丝杆可由各种生物相容的材料制成，各种生物相容的材料包括在可释放的医疗器械制造中通常所使用的材料，例如记忆合金材料、优选为镍钛合金；第一支撑骨架2011及第二支撑骨架2051也可使用可降解材料制成，即，每一支撑丝杆由可降解材料制成，可降解材料制成包括如聚乳酸PLA、聚己内酯PCL、聚乙交酯PGA或聚对二氧环已酮PDO等；所述支撑骨架还可以使用高分子聚合物材料等。
本实施例中，第一支撑骨架2011的四周边缘向第二支撑骨架2051倾斜弯折，第二支撑骨架2051的四周边缘向第一支撑骨架2011倾斜弯折。具体地，第一支撑骨架2011的每一支撑丝杆远离第一支撑骨架2011的几何中心处向第二支撑骨架2051倾斜弯折；第二支撑骨架2051的每一支撑丝杆远离第二支撑骨架2051的几何中心处向第一支撑骨架2011倾斜弯折。当第一封堵盘201及第二封堵盘205共同夹持卵圆孔200周围的组织时，第一封堵盘201与第二封堵盘205中部之间的间距大于四周边缘之间的间距，使第一封堵盘201与第二封堵盘205能更牢固地夹持卵圆孔周围的原发膈301和继发膈303。
如图2、图3及图4所示，第一封堵盘201还包括设置于其中心区域的第一钢套2015，优选地，第一钢套2015设置于第一封堵盘201的几何中心，第一封堵盘201的支撑丝杆2012与第一钢套2015连接并围绕在第一钢套2015的周围，以形成第一支撑骨架2011。第一钢套2015呈管状，第一钢套2015设置有沿第一封堵盘2011的厚度方向(垂直于第一封堵盘201盘面的方向)延伸的通孔，若干支撑丝杆2012的自由端固定设置于所述第一钢套 2015的外周面或内周面。本实施例中，若干支撑丝杆2012的自由端容置于第一钢套2015的内腔，且通过焊接或粘接的方式固定连接于第一钢套2015。第一钢套2015的材质为不锈钢、镍钛合金或其他生物相容性材料。
第二封堵盘205还包括设置于其中心区域的第二钢套2055，第二钢套2055与第二支撑骨架2051连接，优选地，第二钢套2055固定设置于第二封堵盘205的几何中心；第二封堵盘205的支撑丝杆围绕在第二钢套2055的周围，以形成第二支撑骨架2051。第二钢套2055呈管状，第二钢套2055沿第二支撑骨架2051厚度方向设置有贯通的穿线孔2056，连接段23的一端穿过穿线孔2056以连接线结22。若干支撑丝杆的自由端固定设置于所述第二钢套2055的外周面或内周面。本实施例中，若干支撑丝杆的自由端通过焊接或粘接的方式固定连接于第二钢套2055的外周面，第二钢套2055的材质为不锈钢、镍钛合金或其他生物相容性材料。
在其他实施例中，第一钢套2015也可以设置于第一封堵盘201的非中心区域；第二钢套2055也可以设置于第二封堵盘205的非中心区域。
在其他实施例中，第一支撑骨架2011及第二支撑骨架2051一般由4～50根支撑丝杆编织而成，相邻支撑丝杆之间形成网孔。以下以第一支撑骨架2011为例进行说明，以下技术方案同样适用于第二第支撑骨架2051：图4中的第一支撑骨架2011由30个圆形的支撑丝杆2012环形阵列而成，图5及图6中的第一支撑骨架2011由6个圆形的支撑丝杆2012环形阵列而成，图6中的第一支撑骨架2011上设置有第一阻流膜2013。
在其他施例中，每一所述支撑丝杆可以是椭圆、半圆形、棱形或不规则形状等。如图7所示，第一支撑骨架2011a由若干椭圆形的支撑丝杆2012沿支撑骨架2012a的中心点环形阵列，每一支撑丝杆2012的其中一个顶端穿过所述中心点，第一支撑骨架2011a的内表面和/或外表面设置有所述阻流膜。如图8所示，第一支撑骨架2011b由若干半圆形的支撑丝杆2012沿第一支撑骨架2011b的中心点环形阵列，每一支撑丝杆2012的其中一个圆弧端点穿过所述中心点；第一支撑骨架2011b的内表面和/或外表面设置有所述阻流膜。如图9所示，第一支撑骨架2011c由若干棱形的支撑丝杆2012沿第一支撑骨架2011c的中心点环形阵列，每一支撑丝杆2012的其中一个顶端穿过所述中心点；第一支撑骨架2011c的内表面和/或外表面设置有所述阻流膜。如图10所示，第一支撑骨架2011d由若干不规则形状的支撑丝杆2012沿第一支撑骨架2011d的中心点环形阵列，每一支撑丝杆2012的其中一个顶端穿过所述中心点；第一支撑骨架2011d的内表面和/或外表面设置有所述阻流膜。
在其他实施例中，每一所述支撑丝杆可以是三角形、多边形等。
收紧线21可选为非吸收生物相容性缝合线，例如金属线、棉线、聚酯、聚丙烯等，收紧线21也可选用可吸收生物相容性缝合线，例如羊肠线、聚乙交酯、多丝非生物可降解缝合线等，收紧线21还可选用强制缠绕纤维线等。
请再次参阅图2及图3，锁紧段24及调节段25分别位于连接段23的两端，线结22位于连接段23与锁紧段24之间。连接段23为收紧线21围成倒U形的调节线环230，调节线环230的两端穿过第二封堵盘205连接线结22，调节线环230远离线结22的部分可 滑动地穿置于第一封堵盘201中。优选地，调节线环230远离线结22及调节段25的部分可滑动地穿置于第一封堵盘201的几何中心，调节线环230的两端分别沿第二封堵盘205的厚度方向穿过第二封堵盘205的几何中心，以使第一封堵盘201及第二封堵盘205的受力更均匀。具体地，调节线环230远离线结22及调节段25的部分穿置于第一封堵盘201，调节线环230的两端分别穿过第二封堵盘205的几何中心位置的网孔，优选地，调节线环230的两端分别穿过第二封堵盘205上的不同网孔，以方便连接输送器50上的不同部件。
在第一封堵盘201与第二封堵盘205上，调节段25与锁紧段24穿过的位置位于第一封堵盘201与第二封堵盘205的几何中心，有利于在拉紧收紧线21时，拉力施加于封堵盘的几何中心，封堵盘受力均匀，方便操控。
优选地，第一封堵盘201上连接连接段23的多个位置相互靠近，及/或第二封堵盘205上连接所述连接段23的多个位置相互靠近；具体地，第一封堵盘201上穿设连接段23的两个网孔的位置彼此靠近；在第二封堵盘205上，连接段23的一端穿设于第二钢套2055的穿线孔2056，连接段23的另一端穿过的网孔靠近穿线孔2056。
若连接段23的两端穿过第一封堵盘201或及第二封堵盘205上的阻流膜的位置跨度较大，阻流膜上用于穿置连接段23的穿孔容易被连接段23倾斜地牵拉而导致穿孔越来越大，影响阻流膜的阻流效果；若穿置连接段23的穿孔太大，后续会使得所述穿孔位置无法内皮化，导致卵圆孔封闭效果欠佳。因此，连接段23在两盘上的穿孔位置聚集，避免了阻流膜上的穿孔被连接段23牵拉而导致穿孔越来越大，有利于长期保持阻流膜的完整性，保证了术后缺损的原发膈301与继发膈303向封堵器表面爬附从而完成内皮化。
调节线环230的一端连接于线结22，调节线环230的另一端穿置于线结22中并连接调节段25。当线结22未被拉紧时，调节段25能够带动与其连接的调节线环230的一端在线结22中滑动，以调节第一封堵盘201与第二封堵盘205之间的调节线环230的长度；锁紧段24用于拉紧线结22，使得线结22勒紧位于其中的调节线环230的一部分，以固定第一封堵盘201与第二封堵盘205之间的调节线环230的长度。
如图3所示，线结22包括相互连接的基础线环221及锁紧线环223，调节线环230的一端连接基础线环221，调节线环230的另一端穿过锁紧线环223连接调节段25；当基础线环221及锁紧线环223未被拉紧时，调节段25能够带动与其连接的调节线环230的一端在锁紧线环223中滑动，以调节第一封堵盘201与第二封堵盘205之间的调节线环230的长度；当拉动锁紧段24使得锁紧线环223与基础线环221依次逐渐收紧，使得调节线环230的一部分被勒紧锁定在锁紧线环223中。
收紧线21包括与锁紧段24连接的第一区段211(如图11所示)，以及与调节段25连接的第二区段213(如图11所示)，第一区段211与第二区段213相互连接；基础线环221由所述第一区段211围成，锁紧线环223由所述第一区段211的剩余部分从基础线环221内穿出而形成；所述第二区段213围成调节线环230。
本申请中定义：第一封堵盘201与第二封堵盘205之间的一侧为内侧，第一封堵盘201背离第二封堵盘205的一侧及第二封堵盘205背离第一封堵盘201的一侧为外侧。调节线 环230的两端自第二封堵盘205的内侧穿过第二封堵盘205至其外侧，调节线环230远离线结22的一端穿置于第一封堵盘201的内侧。
请一并参阅图11至图15，收紧线21与第一封堵盘201及第二封堵盘205组装于一体的过程如下：
1、如图11所示，收紧线21的一端穿过第一封堵盘201的不同网孔，比如第一封堵盘201内侧几何中心处的两个径向间隔的网孔后，折回至第一封堵盘201的内测，即靠近收紧线21的另一端，使收紧线21远离端部的部分可滑动地穿置于第一封堵盘201上。此时，收紧线21形成倒U形，收紧线21的第一区段211与第二区段213分别位于第一封堵盘201的轴向的中心线的两侧，第一区段211远离第一封堵盘201的端部连接锁紧段24，第二区段213远离第一封堵盘201的端部连接调节段25。
2、如图12所示，将调节段25从第二封堵盘205的内侧向外侧穿过第二钢套2055的穿线孔2056，将锁紧段24从第二封堵盘205的内侧向外侧穿过靠近第二钢套2055的支撑骨架之间的网孔，使调节段25及锁紧段24的自由端并列于第二封堵盘205的外侧，收紧线21在第一封堵盘201与第二封堵盘205之间的部分形成调节线环230。
3、如图13-图15所示，收紧线21在第二封堵盘205外侧设置由第一区段211及第二区段213缠绕形成的线结22，线结22能够将锁紧段24和调节段25锁固并抵接于第二封堵盘205的外侧，以定位调节线环230的长度。本实施例中，以第一区段211缠绕形成的线结22的打结方法具体描述：
A.如图13所示将第一区段围成一线圈得到基础线环221；具体地，将收紧线21第一区段的两部分交叠而围成一个线围，即得到基础线环221；
B.如图14所示将第一区段中的剩余部分从基础线环221中穿出得到锁紧线环223。第一区段中的剩余部分连接锁紧段24，第一区段中的剩余部分从基础线环221的一侧(比如图14中纸面向外的一侧)绕至基础线环221的另外一侧(比如图14中纸面向内的一侧)，再自基础线环221的所述另外一侧从基础线环221中穿出至基础线环的所述一侧，得到呈U形的锁紧线环223，锁紧段24保持在基础线环221之外；
C.如图15所示将调节段25穿过锁紧线环223，使得第二区段在封堵器的第一封堵盘201与第二封堵盘205之间形成调节线圈230，从而得到收紧件21。
本申请封堵系统100在使用过程中需与导引导丝、输送器50、扩张器等配合使用。手术过程如下：
1、将导引导丝置入左上肺静脉，保留导引导丝，将输送鞘管、扩张器置入左心房中部，退出扩张器和导引导丝；
2、保持输送鞘管不动，负载第一封堵盘201及第二封堵盘205的输送器50的输送杆插入输送鞘管的后端后再向前推送输送器，首先将输送杆的前端推出输送鞘管；
3、释放相对远离输送器50的第一封堵盘201在左心房内，直到第一封堵盘201在左心房内展开；随后将输送鞘管和输送器50一起回撤，当输送鞘管回撤到右心房内时，释放第二封堵盘205，直到第二封堵盘205在右心房内展开；此时，线结22处于松弛状态，基 础线环221、锁紧线环223及调节线环230均处于松弛状态，各个线环没有被拉紧。
4、通过输送器50向近端拉动调节段25的自由端，使调节线环230的长度缩小，从而缩短第一封堵盘201与第二封堵盘205之间的收紧线21的长度，带动第一封堵盘201及第二封堵盘205相对于心房间隔移动，直至第一封堵盘201的内侧贴合于卵圆孔200周围的心房间隔的一侧，第二封堵盘205的内侧贴合于卵圆孔200周围的心房间隔的另一侧；
5、当卵圆孔200周围的心房间隔被第一封堵盘201及第二封堵盘205牢固地夹持时，通过输送器50向近端拉动锁紧段24的自由端，使时锁紧线环223逐渐收紧，锁紧线环223收紧后带动基础线环221也进行锁紧，最终锁紧线环223与基础线环221均被拉紧，使调节线环230连接调节段25的一端被锁紧线环223勒紧锁定，并被固定在锁紧线环223与基础线环221之间，即基础线环221与锁紧线环223共同锁定了调节线环230，调节线环230在第一封堵盘201及第二封堵盘205之间的长度尺寸被固定，使得第一封堵盘201及第二封堵盘205夹持所述心房间隔。
6、打结完成后，经输送鞘管将剪线器推送至右心房，在距离线头3～5mm处将缝线剪断，撤回输送鞘管和剪线器，完成卵圆孔200的封堵。
请参阅图16，本申请第二实施例提供的封堵器释放后的结构与第一实施例的结构相似，不同之处在于：第二实施例中的封堵器的收紧线21a的线结22a的结构与第一实施例中的线结22的结构略有不同，线结22a的第一实施例的结构22的基础上增加了增强线环226。增强线环226的一端连接于基础线环221，增强线环226的另一端穿过基础线环221与锁紧线环223之间的缝隙连接调节线环230。拉紧锁紧段24后，基础线环221与锁紧线环223在收紧的过程中，除锁紧线环223勒紧调节段25之外，基础线环221还勒紧增强线环226的两端，从而加强锁紧线环223锁紧调节段25的能力。
如图17-图19所示，线结22a的打结方法与线结22的打结方法相似，具体如下：
1、如图17所示将收紧线21的第一区段的两端交叠而围成一个线围，得到基础线环221；
2、如图18所示将第一区段围成基础线环221之后的剩余部分从基础线环221中穿出得到U形的锁紧线环223；
3、如图19所示将调节段25沿第一方向从基础线环221与锁紧线环223之间的缝隙穿过，从而得到增强线环226；
4、如图20所示将调节段25沿与第一方向相反的第二方向穿过锁紧线环223，使得收紧线21在基础线环221与锁紧线环223之间的部分围成调节线圈230，从而得到收紧件21a。
收紧件21a的基础线环221与锁紧线环223部分交叠，所述第一方向与所述第二方向的取向可以是如下两种情况之一：
1、第一方向为由锁紧线环223的一侧指向基础线环221的一侧，比如图19中垂直纸面向内的方向。
2、第一方向为由基础线环221的一侧指向锁紧线环223的一侧，比如图19中垂直纸面向外的方向。
第二实施例中的收紧线21a与第一封堵盘201及第二封堵盘205的组装方法与第一实施例相似，即在线结22a的打结之前，先将收紧线21a的一端穿过第一封堵盘201的网孔，再折回至第一封堵盘201的内测靠近收紧线21a的另一端，使得收紧线21a位于第一封堵盘201的内侧；再将收紧线21a的其中一端部从第二封堵盘205的内侧向外侧穿过第二钢套2055的穿线孔2056，收紧线21a的另一端部从第二封堵盘205的内侧向外侧穿过靠近第二钢套2055的网孔，使收紧线21a的两端并列于第二封堵盘205的外侧，收紧线21a在第一封堵盘201与第二封堵盘205之间的部分形成调节线环230；再执行线结22a的打结方法即可。
第二实施例中的封堵系统的使用过程与第一实施例中的封堵系统的使用过程相同，在此不再描述。
在其他变更实施方式中，锁紧段24与调节段25还可以绕调节线环230以及锁紧线环223做其他多次穿插或缠绕，以不妨碍实现调节长度以及锁紧功能为限。
在其他变更实施方式中，线结22还可采用其他的打结方式，即设置在第一封堵盘201与第二封堵盘205上，能够实现调节连接段23长度并能够锁定的线结22均可。
在其他变更实施方式中，第一封堵盘201与第二封堵盘205省略设置第一钢套2015与第二钢套2055，收紧线21通过穿置第一封堵盘201与第二封堵盘205的网孔以实现与第一封堵盘201与第二封堵盘205的连接。
在其他变更实施方式中，第一封堵盘201与第二封堵盘205可以分别为单层网状盘，双层网状盘。
在其他变更实施方式中，在第一实施例的基础上增加垫片，具体地，第二封堵盘205的外侧在几何中心位置设置有垫片，所述垫片沿第二封堵盘205的厚度方向开设两个间隔的通孔，如图2所示，其中一个通孔对应第二钢套2055的穿线孔2056，以便于调节线环230的一端穿过；另一个通孔对应调节线环23的另一端，以便于调节线环23的另一端穿过。线结22、锁紧段24及调节段25均位于所述垫片背离第二封堵盘205的一侧。本实施方式中，所述垫片能使第二封堵盘205的外侧受力更均匀，从而第一封堵盘201与第二封堵盘205之间的夹持力更加均匀，使闭合封堵更稳定。
为了说明方便，以上方法步骤中的都使用了序号，需要说明的是，以上序号不用于限定步骤之间的前后关系；在不违背本申请精神的情况下，以上各个实施例中的具体技术方案可以相互适用。
以上是本申请实施例的实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请实施例原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本申请的保护范围。

Claims (22)

  1. 一种封堵器，用于封堵脉管系统中的缺损，其特征在于，所述封堵器包括：
    两封堵盘，用于覆盖所述缺损的不同开口；以及
    收紧件，包括收紧线，所述收紧线用于穿置于所述缺损中，并连接所述两封堵盘，所述两封堵盘之间的收紧线的长度能够通过所述收紧线的自由端调节。
  2. 根据权利要求1所述的封堵器，其特征在于，所述两封堵盘分别为第一封堵盘与第二封堵盘，所述收紧线包括：
    线结；
    与所述线结连接的连接段，连接在所述第一封堵盘与所述第二封堵盘之间；以及
    与所述线结连接的锁紧段与调节段，分别包括一所述自由端；
    所述锁紧段、所述调节段与所述线结均设置于所述第二封堵盘背离所述第一封堵盘的一侧，所述连接段的长度能够通过所述调节段调节。
  3. 根据权利要求2所述的封堵器，其特征在于，所述连接段连接于所述第一封堵盘的几何中心，及/或所述连接段连接于所述第二封堵盘的几何中心。
  4. 根据权利要求2所述的封堵器，其特征在于，所述第一封堵盘上连接所述连接段的多个位置相互靠近，及/或所述第二封堵盘连接所述连接段的多个位置相互靠近。
  5. 根据权利要求2所述的封堵器，其特征在于，所述连接段为所述收紧线围成的调节线环，所述调节线环的两端穿过所述第二封堵盘连接所述线结，所述调节线环远离所述线结的部分穿置于所述第一封堵盘中。
  6. 根据权利要求5所述的封堵器，其特征在于，所述调节线环的一端穿置于所述线结中连接所述调节段；
    当所述线结未被拉紧时，所述调节段能够带动与其连接的调节线环的一端在所述线结中滑动，以调节所述第一封堵盘与所述第二封堵盘之间的调节线环的长度；
    所述锁紧段用于拉紧所述线结，使得所述线结勒紧位于其中的调节线环的一部分，固定所述第一封堵盘与所述第二封堵盘之间的调节线环的长度。
  7. 根据权利要求6所述的封堵器，其特征在于，
    所述线结包括相互连接的基础线环及锁紧线环，所述调节线环的一端连接所述基础线环，所述调节线环的另一端穿过所述锁紧线环连接所述调节段；
    当所述基础线环及所述锁紧线环未被拉紧时，所述调节段能够带动与其连接的调节线环的一端在所述锁紧线环中滑动，以调节所述第一封堵盘与所述第二封堵盘之间的调节线环的长度；
    拉动所述锁紧段使得所述锁紧线环与所述基础线环依次逐渐收紧，使得所述调节线环的一部分被勒紧锁定在所述锁紧线环中。
  8. 根据权利要求7所述的封堵器，其特征在于，所述收紧线包括与所述锁紧段连接的第一区段，以及与所述调节段连接的第二区段，所述第一区段与所述第二区段相互连接；
    所述基础线环由所述第一区段围成，所述锁紧线环由所述第一区段的剩余部分从所述 基础线环内穿出而形成；
    所述第二区段围成所述调节线环。
  9. 根据权利要求7所述的封堵器，其特征在于，所述线结还包括增强线环，
    所述增强线环的一端连接于所述基础线环，所述增强线环的另一端穿过所述基础线环与所述锁紧线环之间的缝隙连接所述调节线环。
  10. 根据权利要求2-9任意一项所述的封堵器，其特征在于，所述收紧线为可吸收生物相容性缝合线。
  11. 根据权利要求1-9任意一项所述的封堵器，其特征在于，所述收紧件还包括连接输送器的固定线，所述输送器通过所述固定线将所述两封堵盘中的一个固定于其远端。
  12. 根据权利要求5-9中任意一项所述的封堵器，其特征在于，所述第一封堵盘包括第一支撑骨架及设置于所述第一支撑骨架上的第一阻流膜，所述收紧线连接所述第一支撑骨架及/或所述第一阻流膜。
  13. 根据权利要求12所述的封堵器，其特征在于，所述第二封堵盘包括第二支撑骨架及设置于所述第二支撑骨架的第二阻流膜，所述调节线环的一端从所述第二支撑骨架中的缝隙穿过所述第二阻流膜连接所述线结。
  14. 根据权利要求13所述的封堵器，其特征在于，所述第二封堵盘还包括钢套，所述钢套与所述第二支撑骨架连接，所述钢套沿所述第二支撑骨架厚度方向设置有贯通的穿线孔，所述调节线环的另一端穿过所述穿线孔以连接所述线结。
  15. 根据权利要求13所述的封堵器，其特征在于，所述第一支撑骨架及所述第二支撑骨架为编织网状结构或者框架结构。
  16. 根据权利要求15所述的封堵器，其特征在于，所述第一支撑骨架与所述第二支撑骨架分别为单层编织网状结构、单层框架结构、双层网状结构或者双层框架结构中的任意一种。
  17. 根据权利要求13所述的封堵器，其特征在于，所述第一支撑骨架的四周边缘向所述第二支撑骨架倾斜弯折，所述第二支撑骨架的四周边缘向所述第一支撑骨架倾斜弯折。
  18. 根据权利要求13所述的封堵器，其特征在于，所述第一支撑骨架及/或所述第二支撑骨架呈花瓣形。
  19. 一种封堵系统，包括如权利要求1至18中任意一项所述的封堵器，所述系统还包括输送器，所述输送器用于释放所述封堵器。
  20. 一种封堵器中收紧件的打结方法，其特征在于，所述收紧件由收紧线缠绕打结制成，所述收紧线包括依次连接的锁紧段、第一区段、第二区段以及调节段，所述打结方法包括以下步骤：
    将所述第一区段围成一线圈得到基础线环；
    将所述第一区段中的剩余部分从所述基础线环中穿出得到锁紧线环；
    将所述调节段穿过所述锁紧线环，使得所述第二区段在所述封堵器的两封堵盘之间形成调节线环，从而得到所述收紧件。
  21. 根据权利要求20所述的封堵器中收紧件的打结方法，其特征在于，
    在步骤“将所述第一区段中的剩余部分从所述基础线环中穿出得到锁紧线环”与步骤“将所述调节段穿过所述锁紧线环，使得所述第二区段在所述封堵器的两封堵盘之间形成调节线环，从而得到所述收紧件”之间，所述打结方法还包括：
    将所述调节段沿第一方向从所述基础线环与所述锁紧线环之间的缝隙穿过，从而得到增强线环；
    步骤“将所述调节段穿过所述锁紧线环，使得所述第二区段在所述封堵器的两封堵盘之间形成调节线环，从而得到所述收紧件”，具体为：
    将所述调节段沿与所述第一方向相反的第二方向穿过所述锁紧线环，使得所述第二区段在所述封堵器的两封堵盘之间形成调节线环，从而得到所述收紧件。
  22. 根据权利要求21所述的封堵器中收紧件的打结方法，其特征在于，所述第一方向为由所述锁紧线环的一侧指向所述基础线环的一侧；或者所述第一方向为由所述基础线环的一侧指向所述锁紧线环的一侧。
PCT/CN2020/137639 2019-12-18 2020-12-18 封堵器、封堵系统及封堵器中收紧件的打结方法 WO2021121395A1 (zh)

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