WO2022033530A1 - 封堵装置 - Google Patents

封堵装置 Download PDF

Info

Publication number
WO2022033530A1
WO2022033530A1 PCT/CN2021/112111 CN2021112111W WO2022033530A1 WO 2022033530 A1 WO2022033530 A1 WO 2022033530A1 CN 2021112111 W CN2021112111 W CN 2021112111W WO 2022033530 A1 WO2022033530 A1 WO 2022033530A1
Authority
WO
WIPO (PCT)
Prior art keywords
proximal
gathering
distal
sleeve
constricting
Prior art date
Application number
PCT/CN2021/112111
Other languages
English (en)
French (fr)
Inventor
李安宁
刘建勇
唐玉华
贾佳
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.)
Filing date
Publication date
Priority claimed from CN202010808213.2A external-priority patent/CN114073560B/zh
Priority claimed from CN202021692923.5U external-priority patent/CN213552081U/zh
Priority claimed from CN202021692698.5U external-priority patent/CN213552080U/zh
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 EP21855581.1A priority Critical patent/EP4197455A1/en
Priority to CA3186828A priority patent/CA3186828A1/en
Priority to US18/040,180 priority patent/US20230320713A1/en
Publication of WO2022033530A1 publication Critical patent/WO2022033530A1/zh

Links

Images

Classifications

    • 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
    • A61B17/12027—Type of occlusion
    • A61B17/12031—Type of occlusion complete occlusion
    • 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
    • A61B17/12—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
    • A61B17/12163—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a string of elements connected to each other
    • 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
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • 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
    • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • 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
    • A61B2017/00606—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
    • A61B2017/00615—Implements with an occluder on one side of the opening and holding means therefor on the other
    • 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
    • A61B2017/00876—Material properties magnetic

Definitions

  • the invention relates to the technical field of interventional medical devices, in particular to a blocking device for blocking openings in the body.
  • the present invention aims to provide an occlusion device that can better serve patients.
  • An occlusion device comprising a first part and a second part connected with the first part, the first part or the second part comprises a plurality of braided wires and a constricting part, the plurality of braided wires are close to the Parts of one end of the plurality of braided filaments cooperate to form a disk surface
  • the blocking device further includes a film member, the film member covers at least part of the outer surface of the disk surface
  • the constricting member includes hollow and sleeved. The inner sleeve and the outer sleeve, one end of the plurality of braided wires and at least a part of the constricting area of the thin film element are all fixed to the condensing element.
  • an opening is provided in the condensing region of the thin film member, and a portion of the thin film member enclosing the opening to form the opening is accommodated and fixed in the condensing member.
  • one end of the constricting member is provided with an end cap connected to the inner sleeve, and the constricting area of the thin film member is at least partially accommodated or fixed between the end cap and the outer sleeve between the tubes.
  • At least a portion of the disk surface close to the condensing element is perpendicular to the central axis of the condensing element.
  • the inner wall of the inner sleeve is provided with a thread or a clamping member.
  • the cavity of the inner sleeve is provided with a limiter extending radially or having an included angle with the central axis of the inner sleeve.
  • the first part or the second part further comprises an extension piece located at the edge thereof, the film piece also covers the extension piece, and the extension piece is expanded radially outward after deployment the thin film.
  • the proximal end of the inner sleeve and the proximal end of the outer sleeve are enclosed to form the proximal entrance of the constrictor, and the distal end of the inner sleeve is and the distal end of the outer sleeve is enclosed to form the distal entrance of the constricting piece, and one end of the plurality of braided wires passes through the proximal entrance or the distal end of the constraining piece After the inlet, it is fixed between the inner sleeve and the outer sleeve.
  • the constraining member is disposed at the proximal end of the first part or the second part, one end of the plurality of braided wires is the proximal end, and when the proximal end of the plurality of braided wires is When being received and secured through the proximal inlet of the banding element, the banding region of the membrane element is at least partially secured to the inner sleeve via the proximal inlet of the banding element and the outer sleeve; or, when the proximal ends of the plurality of braided wires are received and fixed through the distal entrance of the constricting member, the condensing region of the thin film member passes through the The proximal inlet or the distal inlet of the constrictor is at least partially received or fixed between the inner sleeve and the outer sleeve.
  • the constricting member is disposed at the distal end of the first part or the second part, and one end of the plurality of braided wires is the distal end, when the distal end of the plurality of braided wires is the distal end
  • the banding region of the membrane element is at least partially accommodated via the proximal inlet or the distal inlet of the banding element or fixed between the inner sleeve and the outer sleeve; or, when the distal ends of the plurality of braided wires are received and fixed through the distal entrance of the constrictor, the membrane A constricted region of the constrictor is at least partially received or secured between the inner and outer sleeves via the distal entry of the constraining element.
  • the condensing member further includes a hollow intermediate sleeve sleeved between the inner sleeve and the outer sleeve.
  • one end of the plurality of braided wires is accommodated or fixed between the outer sleeve and the middle sleeve, or is accommodated or fixed between the middle sleeve and the inner sleeve between.
  • the proximal end of the outer sleeve and the proximal end of the intermediate sleeve are enclosed to form the outer proximal entrance of the constrictor, and the proximal end of the intermediate sleeve is The inner sleeve and the proximal end of the inner sleeve are enclosed to form the inner proximal entrance of the constrictor, and the distal end of the outer sleeve and the distal end of the intermediate sleeve are enclosed to form a the outer distal inlet of the bundle, the distal end of the intermediate sleeve and the distal end of the inner sleeve are enclosed to form the inner distal inlet of the bundle; the bundle It is arranged at the proximal end of the first part or the second part, one end of the plurality of braided wires is the proximal end, and one end of the plurality of braided wires passes through the outer proximal end inlet and the outer
  • the proximal end of the outer sleeve and the proximal end of the intermediate sleeve are enclosed to form the outer proximal entrance of the constrictor, and the proximal end of the intermediate sleeve is The inner sleeve and the proximal end of the inner sleeve are enclosed to form the inner proximal entrance of the constrictor, and the distal end of the outer sleeve and the distal end of the intermediate sleeve are enclosed to form a the outer distal inlet of the bundle, the distal end of the intermediate sleeve and the distal end of the inner sleeve are enclosed to form the inner distal inlet of the bundle; the bundle It is arranged at the distal end of the first part or the second part, one end of the plurality of braided wires is the distal end, and one end of the plurality of braided wires passes through the outer proximal end inlet, the inner proximal
  • An occlusion device includes a first part, the first part includes a plurality of braided wires and a constricting member, one end of the plurality of braided wires is fixed to the constricting member, the first part has at least one disk surface, and the A portion of the plurality of braided filaments forms a gathered portion through shape convergence, the gathering element is located in the space enclosed by the gathered portion, and at least one of the disk surfaces formed by the gathered portion is flat and closed.
  • the gathering portion includes a first gathering portion and a second gathering portion, and the first gathering portion and the second gathering portion are close to each other when no external force acts, so as to bind the gathering member It is enclosed in the space enclosed by the first gathering part and the second gathering part; the first gathering part and the second gathering part can move away from each other under the action of external force.
  • the maximum outer diameter of the gap formed after the first gathering part and the second gathering part approach each other is less than or equal to 5 mm; or, the first gathering part and the second gathering part The parts are close to each other and are in contact with each other at least in the radial direction.
  • a closing member is provided at the gap formed by the first gathering portion and the second gathering portion, so that at least one of the disk surfaces formed by the gathering portion is closed.
  • the first gathering portion includes at least one raised portion
  • the second gathering portion includes at least one concave portion
  • the first part is further provided with a restoring member, and after the first gathering portion and the second gathering portion are removed from the external force, the restoring member restores the first gathering portion and the second gathering portion.
  • the second gathering parts gather with each other.
  • the reset member includes at least two magnets with opposite magnetic properties, and the first gathering portion and the second gathering portion gather with each other under the action of the at least two magnets.
  • the reset member includes a first reset lever disposed near the first gathering portion and a second reset lever disposed near the second gathering portion, the first gathering portion and the first gathering portion The two gathering parts are gathered together under the action of the first reset lever and the second reset lever.
  • the reset member includes at least one elastic coil connecting the first gathered portion and the second gathered portion, and the first gathered portion and the second gathered portion are in the elastic coil gather together under the influence of each other.
  • the blocking device further includes a film member covering at least part of the outer surface of the gathering portion.
  • a thin film member is arranged on the disk surface of the first part to improve the sealing performance of the first part, and at the same time, a constricting member including an inner sleeve and an outer sleeve is used to constrain and fix a plurality of braids constituting the first part.
  • the end of the braided wire is used to accommodate and fix the part of the constricted area of the film element through the constricting element, so that the part of the film element is stably fixed on the first part, so that the film element does not easily occur on the first part. move or fall off.
  • the first part is provided with a gathering part formed by a part of a plurality of braided wires through shape convergence.
  • the gathering part can bind the constricting member. It is enclosed in the space enclosed by the converging part, so that the constricting element does not protrude from the disk surface located on the periphery of the first part, preventing blood flow from forming thrombus near the constricting element, and improving the safety of the occluding device.
  • Example 1 is a schematic diagram of one of the overall structures of the plugging device of Example 1;
  • Fig. 2 is one of the structural representations of the first part in the embodiment 1;
  • Fig. 3 is the enlarged structure schematic diagram of the circular dotted line portion in Fig. 2;
  • Fig. 4 is another kind of structural representation of the first part in the embodiment 1;
  • Fig. 5 is another kind of structural representation of the first part in the embodiment 1;
  • Fig. 6 is the enlarged structure schematic diagram of the circular dotted line part in Fig. 5;
  • Fig. 7 is another kind of structural representation of the first part in the embodiment 1;
  • Fig. 8 is the enlarged structure schematic diagram of the circular dotted line portion in Fig. 7;
  • Fig. 10 is the enlarged structure schematic diagram of the circular dotted line portion in Fig. 9;
  • Example 11 is a schematic view of the unfolded structure of the film member provided with the openings in Example 1;
  • Fig. 13 is the enlarged structural schematic diagram of the circular dotted line portion in Fig. 12;
  • Example 14 is a schematic diagram of the deployed structure at the proximal end of the first part in Example 5;
  • FIG. 16 is an enlarged schematic view of another implementation of the circular dotted line portion in FIG. 15;
  • FIG. 17 is an enlarged structural schematic diagram of another implementation manner of the circular dotted line portion in FIG. 15;
  • FIG. 18 is a schematic view of one of the structures of the condensing member in Embodiment 6;
  • Example 19 is a schematic diagram of one of the overall structures of the plugging device in Example 10.
  • 20A is a schematic structural diagram of the occlusion device in Example 10 when it is implanted into the body tissue and connected to the delivery wire;
  • Figure 20B is a schematic longitudinal cross-sectional view of the first part in Figure 20A;
  • 21A is a schematic structural diagram of the occlusion device in Example 10 when it is implanted into the body tissue and disconnected from the delivery wire;
  • Figure 21B is a schematic longitudinal cross-sectional view of the first part in Figure 21A;
  • FIG. 25 is another schematic structural diagram of the first part in Embodiment 10.
  • FIG. 25 is another schematic structural diagram of the first part in Embodiment 10.
  • proximal end the end of the medical device implanted in the human body or animal body that is closer to the operator
  • distal end the end of the medical device implanted in the human body or animal body that is closer to the operator
  • proximal end the end of the medical device implanted in the human body or animal body that is closer to the operator
  • distal end the end farther from the operator
  • proximal end the end of the medical device implanted in the human body or animal body that is closer to the operator
  • distal end the end farther from the operator
  • the condensing element located relatively at the proximal end is referred to as the proximal condensing element
  • the condensing element relatively located at the distal end is referred to as the distal condensing element.
  • the disk surface relatively located at the proximal end is called the proximal disk surface
  • the disk surface relatively located at the distal end is called the distal disk surface.
  • the sealing disc of the existing occluder only uses the disc surface formed by the heat-setting of the mesh tube woven with the braided wire for sealing.
  • the braided wires of the sealing disc need to be braided more densely, so more braided wires are required, resulting in a larger outer diameter of the sealing disc after being accommodated in the sheath, so it is necessary to Sheath fitting with larger inner diameter.
  • the smaller the outer diameter of the sheath the better.
  • the present invention exemplarily provides the occlusion devices shown in the following embodiments 1 to 9 to solve the above-mentioned problems, so that they can better serve patients.
  • the occlusion device 100 includes a first part 110 located at the proximal end and a second part 120 located at the distal end.
  • the distal end of the first part 110 is close to the second part 120
  • the ends are directly connected, or the distal end of the first part 110 and the proximal end of the second part 120 are indirectly connected by at least one connector 130, which may be rigid or flexible.
  • the first portion 110 can be used to occlude an opening or hole in a tissue in the body, and the second portion 120 can be used to secure the occlusion device 100 in a cavity of a tissue in the body.
  • the occlusion device 100 is used to occlude the left The opening of the auricle.
  • the second portion 120 may also be used to close openings or holes in tissue in the body.
  • both the first portion 110 and the second portion 120 can be used to occlude an opening or hole in a tissue in the body, for example, where the occlusion device 100 is used to occlude an opening in the atrial or interventricular septum, or In the case of a patent foramen ovale, at this time, the first part 110 and the second part 120 cooperate with each other to fix the occlusion device 100 in the vicinity of the opening or hole in the body tissue.
  • the first part 110 includes a plurality of braided wires 111 and two bundles 112/113, wherein each braided wire 111 has opposite proximal and distal ends, the plurality of braided wires 111 can be braided to form a mesh tube, and a plurality of The braided wire 111 also includes opposite proximal ends and distal ends, and assumes a shape of a disc or a column after heat setting.
  • the first portion 110 includes at least a proximal disk 114 and a distal disk 115 .
  • the proximal disk surface 114 of the first portion 110 is formed by the cooperation of portions of the plurality of braided wires 111 of the first portion 110 that are close to the proximal ends of the plurality of braided wires 111 .
  • the distal disk surface 115 of the first part 110 is formed by cooperation with parts of the plurality of braided wires 111 of the first part 110 that are close to the distal ends of the plurality of braided wires 111 .
  • the portion where the proximal disk surface 114 and the distal disk surface 115 of the first portion 110 are connected forms the edge 116 of the first portion 110 .
  • the proximal constrictor 112 of the first part 110 includes an inner sleeve and an outer sleeve that are both hollow and sheathed, and the proximal ends of the plurality of braided wires 111 are accommodated and fixed between the inner sleeve and the outer sleeve, so that a plurality of braided wires 111 are accommodated and fixed between the inner sleeve and the outer sleeve.
  • the proximal end of the wire 111 is fixed to the proximal end constrictor 112 .
  • the distal end constrictor 113 of the first part 110 may be a hollow sleeve for receiving and fixing the distal ends of the plurality of braided wires 111 inside the sleeve, so that the distal ends of the plurality of braided wires 111 are fixed in the sleeve.
  • Distal band 113 may also have the same structure as the proximal constrictor 112 of the first part 110 , that is, it includes an inner sleeve and an outer sleeve that are both hollow and sleeved.
  • the distal ends of the plurality of braided wires 111 are accommodated and fixed between the inner sleeve and the outer sleeve of the distal constricting member 113 .
  • the specific structure of the second part 120 is not limited, as long as the blocking device 100 can be fixed in the cavity of the in vivo tissue after being released.
  • the second part 120 can be obtained by laser cutting an alloy tube with shape memory properties and heat-setting, or can be obtained by braiding and then heat-setting a plurality of braided wires 111 .
  • the distal portion of the second portion 120 may be closed or may have an opening.
  • the second part 120 includes a plurality of braided wires 121 and two bundles 122/123, wherein the plurality of braided wires 121 can be braided to form a columnar braided mesh, and the proximal end of the braided mesh is covered by the second part
  • the proximal end constrictor 122 of the 120 is accommodated and fixed, and the distal end of the woven mesh is accommodated and fixed by the distal end constrictor 123 of the second part 120 .
  • the proximal constrictor 122 of the second part 120 may include an inner sleeve and an outer sleeve, both of which are hollow and sheathed, for receiving and fixing the proximal ends of the plurality of braided wires 121 of the second part 120 to the inner sleeve and the outer casing.
  • the proximal end constrictor 122 of the second part 120 can also be a hollow sleeve for receiving and fixing the proximal ends of the plurality of braided wires 121 of the second part 120 to the sleeve internal.
  • the distal end constrictor 123 of the second part 120 can also be a hollow sleeve for receiving and fixing the distal ends of the plurality of braided wires 121 of the second part 120 inside the sleeve.
  • the distal constrictor 123 of the second part 120 may also have the same structure as the proximal constrictor 112 of the first part 110, that is, it includes an inner sleeve and an outer sleeve that are both hollow and sheathed, The distal ends of the braided wires 121 of the second portion 120 are accommodated and fixed between the inner sleeve and the outer sleeve.
  • the distal end of the first part 110 may not be provided with the distal constrictor 113
  • the proximal end of the second part 120 may not be provided with a proximal End cuffs 122 .
  • the occlusion device 100 further includes a membrane member, which may be disposed on the first portion 110 and/or the second portion 120 .
  • a membrane member which may be disposed on the first portion 110 and/or the second portion 120 .
  • the film member 117 covers a part of the outer surface of the proximal disk surface 114 of the first portion 110 , so as to specifically enhance the sealing performance of the local area of the proximal disk surface 114 as required.
  • the thin film 117 on the first part 110 may further cover the edge 116 of the first part 110 .
  • the film member 117 on the first portion 110 may also cover the distal disk surface 115 of the first portion 110 , that is, the film member 117 covers the proximal disk surface 114 , the edge 116 and the distal end of the first portion 110 .
  • Disc 115 covers a part of the outer surface of the proximal disk surface 114 of the first portion 110 , so as to specifically enhance the sealing performance of the local area of the proximal disk surface 114 as required.
  • the thin film 117 on the first part 110 may further cover the edge 116 of the first part 110 .
  • the film member 117 on the first portion 110 may also cover the distal disk surface 115 of the first portion
  • the constricting area 118 of the thin film member 117 refers to the part of the thin film member 117 located near the condensing member, and the condensing member may be located at the center of the thin film member 117 or other positions;
  • the gathering area 118 of the thin film member 117 may refer to a portion of the thin film member 117 that is close to the corresponding proximal gathering member 112 or distal gathering member 123 .
  • the condensing area 125 of the thin film member 124 on the second part 120 can be defined.
  • the membrane member 117 can be made of PET film or PTFE membrane, so it not only has good sealing performance, but also can promote the endothelial crawling on the membrane member 117 under the impact of blood flow, thereby further improving the sealing performance.
  • the proximal disk surface 114 and the edge 116 of the first part 110 are covered with a film member 117 , and the film member 117 may be one or more layers.
  • a part of the constricting area 118 of the thin film member 117 is fixed in the proximal converging part 112 of the first part 110 , specifically, the inner sleeve 1121 and the outer sleeve 1122 which are clamped in the proximal converging part 112 Therefore, they are fixed between them, or they can be clamped on the inner sleeve 1121 and the outer sleeve 1122, and the inner sleeve 1121 and the outer sleeve 1122 are connected together to be relatively fixed.
  • portions of the membrane member 117 may be sutured to the proximal disk surface 114 of the first portion 110, or bonded to the proximal disk surface 114 of the first portion 110 with an adhesive.
  • the edge of the film member 117 covers the edge 116 of the first part 110 , which can reduce the damage caused by the edge 116 of the first part 110 to the tissue in the body, such as scratching.
  • the edge of the film member 117 can be fixed on the braided wire 111 at the edge 116 by sewing thread, or fixed at the edge 116 by means of adhesive bonding or the like.
  • the proximal ends of the plurality of braided wires 111 on the first part 110 are fixed between the inner sleeve 1121 and the outer sleeve 1122 of the proximal constrictor 112, and the fixing method can be clamped and fixed by the inner sleeve 1121 and the outer sleeve 1122,
  • the proximal ends of the plurality of braided wires 111 may also be fixed to the distal end of the outer sleeve 1122 by welding or the like, and the fixing method is not limited.
  • the membrane member 117 can be a complete circular membrane without obvious openings. After the film member 117 is sandwiched between the inner sleeve 1121 and the outer sleeve 1122 of the proximal constricting member 112, the distal opening 1123 of the inner sleeve 1121 is covered by the most central part of the film member 117, thereby blocking the film. The distal opening 1123 of the inner sleeve 1121 prevents blood flow from flowing into the interior of the first part 110 through the inner sleeve 1121 , thereby improving the sealing performance of the occlusion device 100 .
  • the inner wall of the inner sleeve 1121 of the proximal constricting member 112 of the first part 110 is provided with a thread 1124 or a clip, which can cooperate with the distal end of the delivery cable to realize a detachable connection, so as to achieve a detachable connection at the first part 110
  • the proximal cuff 112 can be used for the purpose of delivering the occlusion device 100 when connected to the delivery wire, and for the purpose of completely releasing the occlusion device 100 and recycling the delivery wire when disconnected.
  • the inner wall of the inner sleeve 1121 of the bundle may not be provided with threads 1124 or clips.
  • the cavity of the inner sleeve 1121 of the proximal constrictor 112 of the first part 110 is provided with a restricting member 1125 radially extending or having an included angle with the central axis of the inner sleeve 1121, which can be used to restrict the delivery of steel
  • the depth that the cable extends into the inner sleeve 1121 when it is connected to the proximal constrictor 112 prevents the distal end of the delivery cable from poking at the membrane element 117 located on the distal end face of the proximal constrictor 112, and can be used for
  • the thin film member 117 is fixed on the proximal gathering member 112 to further enhance the stability of the thin film member 117 in the proximal gathering member 112 .
  • the restricting member 1125 is a plug that penetrates through the tube wall of the inner sleeve 1121 and the outer sleeve 1122 of the proximal constricting member 112 , and two opposite There are also two opposite through holes on the wall of the outer sleeve 1122, and one end of the pin passes through the through holes of the outer sleeve 1122, the through holes of the inner sleeve 1121, the through holes of the inner sleeve 1121 from the outside to the inside in turn.
  • the through hole and the through hole of the outer sleeve 1122 , and both ends of the final pin are respectively accommodated and fixed in the two through holes of the outer sleeve 1122 .
  • the restricting member 1125 can also be other rod-shaped components, and both ends of the restricting member 1125 can also protrude from the wall of the outer sleeve 1122; After the tube wall of the tube 1122, the restriction on the movement of the restricting member 1125 in the radial direction is formed by the shape constraint.
  • the outer diameter in the axial direction may be larger than the diameter of the through hole on the wall of the outer sleeve 1122 for accommodating the restricting member 1125 .
  • the restricting member 1125 only penetrates the tube wall of the inner sleeve 1121 , and both ends of the restricting member 1125 are respectively received and fixed in the two through holes of the inner sleeve 1121 .
  • the restricting member 1125 may not be provided in the proximal converging member 112 .
  • proximal disk surface 114 of the first portion 110 that is close to the proximal converging member 112 is perpendicular to the central axis of the proximal converging member 112 , thereby forming a relatively close proximity to the proximal converging member 112 .
  • the flat disk surface avoids the risk of thrombus formation near the proximal constrictor 112 and improves safety.
  • the flat disk surface means that there are no obvious protruding parts on the surface of the disk surface. Even if there are several protruding parts, the height of these protruding parts protruding outward relative to other parts is less than or equal to 2 mm.
  • At least the portion 1142 of the proximal disk surface 114 of the first portion 110 close to the proximal constrictor 112 may be arranged not to be perpendicular to the central axis of the proximal constrictor 112 .
  • the proximal end of the proximal constricting member 112 is provided with an end cap 1126 connected to the inner sleeve 1121 , and the constricting area 118 of the membrane member 117 is at least partially It is received or fixed between the end cap 1126 and the outer sleeve 1122 , so as to further firmly fix the film member 117 in the proximal end constricting member 112 .
  • the proximal ends of the plurality of braided wires 111 on the first portion 110 protrude from the space between the end cap 1126 and the outer sleeve 1122 into the space between the inner sleeve 1121 and the outer sleeve 1122 until reaching the distal end of the outer sleeve 1122 After the end, it is fixed to the distal end of the proximal constrictor 112 by welding or the like. Specifically, as one of the implementation methods, it can be fixed to the distal end of the outer sleeve between the ends.
  • the distal end of the proximal constrictor 112 may also be provided with an end cap 1126 connected with the outer sleeve 1122 or the inner sleeve 1121 , so as to further firmly fix the membrane element 117 on the proximal constrictor 112 Inside, the opening at the distal end of the proximal constrictor 112 can also be blocked to improve the sealing performance.
  • the condensing area 118 of the film element 117 is provided with an opening 1171 as shown in FIG. 11 , and the portion of the film element 117 that encloses the opening 1171 is accommodated and fixed in the Inside the proximal end band 112 .
  • the portion of the film member 117 enclosing the opening 1171 protrudes from the gap between the end cap 1126 and the outer sleeve 1122 to the space between the inner sleeve 1121 and the outer sleeve 1122, it is annular or tubular, and is in a ring shape or a tubular shape.
  • a portion of the braided wire 111 is clamped together between the inner sleeve 1121 and the outer sleeve 1122.
  • a membrane member 117 can be used in situations where the distal opening 1123 of the proximal constrictor 112 needs to be not closed, for example, where a substance or component needs to be delivered distally through the distal opening 1123 .
  • the end cap 1126 may be provided with a thin groove, and the portion of the film member 117 enclosing the opening 1171 may be fixedly clamped in the thin groove of the end cap 1126, and the specific manner is not limited.
  • the proximal constricting member 112 may not be provided with the restriction member 1125 or the end cap 1126, and the inner sleeve 1121 may not be provided with the thread 1124 or the clamping member.
  • the proximal end of the inner sleeve 1121 and the proximal end of the outer sleeve 1122 are enclosed to form the proximal entrance of the proximal constrictor 112 , the distal end of the inner sleeve 1121 and the distal end of the outer sleeve 1122
  • the distal entrance of the proximal constrictor 112 is formed by enclosing, and the proximal ends of the plurality of braided wires 111 of the first part 110 are accommodated or fixed inside after passing through the proximal entrance or the distal entrance of the proximal constrictor 112 Between the sleeve 1121 and the outer sleeve 1122.
  • the constricting area of the thin film member 117 118 is at least partially secured between the inner cannula 1121 and the outer cannula 1122 via the proximal entry 1127 of the proximal bundle 112 .
  • the proximal ends of the plurality of braided filaments 111 of the first portion 110 are received and secured through the distal entrance 1128 of the proximal gathering member 112, as shown in FIGS.
  • the gathering region 118 of the membrane member 117 passes through The distal inlet 1128 of the proximal constrictor 112 is at least partially received or fixed between the inner sleeve 1121 and the outer sleeve 1122 .
  • the membrane 117 when the proximal ends of the plurality of braided filaments 111 of the first portion 110 are received and secured through the distal entry 1128 of the proximal gather 112, as shown in FIGS. 9 and 10, the membrane 117
  • the constricting region 118 of the proximal constrictor 112 is at least partially received or fixed between the inner sleeve 1121 and the outer sleeve 1122 via the proximal entrance 1127 of the proximal constrictor 112 .
  • the inside of the first part 110 is further provided with at least one layer of blocking film, which is used to prevent blood from flowing into the inside of the first part 110 from the proximal disk surface 114 of the first part 110 , thereby further improving the blocking of the first part 110 performance.
  • Embodiment 2 The same parts of the occlusion device of Embodiment 2 as those of Embodiment 1 will not be repeated here.
  • the main difference between the two is that the proximal constrictor 112 or the distal constrictor of the first part 110 described in Embodiment 1 113, the same can be used for the second part 120.
  • the film member 124 of the second portion 120 covers the outer surface and the edge 127 of the proximal disk surface 126 of the second portion 120 , and the converging region 125 of the film member 124 is at least partially fixed Within the proximal beamer 122 of the second portion 120 .
  • the edge 127 of the second portion 120 is the side portion between the proximal disk 126 and the distal disk 128 of the second portion 120 .
  • the film member 124 on the second portion 120 may further cover the distal disk surface 128 of the second portion 120 , that is, the film member 124 covers the proximal disk surface 126 and the edge of the second portion 120 .
  • the membrane member 124 of the second portion 120 covers only the outer surface of the proximal disk 126 or the outer surface of the distal disk 128 , or the outer surface and the edge 127 of the distal disk 128 of the second portion 120 . In other embodiments, the membrane member 124 can cover a part of the outer surface of the proximal disk surface 126 or the distal disk surface 128 to specifically enhance the sealing of the local area of the proximal disk surface 126 or the distal disk surface 128 as required.
  • Embodiment 3 The same parts of the occlusion device of Embodiment 3 as those of Embodiment 1 will not be repeated here, and the main difference between the two is that the proximal constrictor 112 described in Embodiment 1 can be disposed at the distal end of the first part 110 .
  • the distal condensing element 113 the features of the two are the same or similar in structure, cooperating manner with the thin film element 117 , and fixing manner in the condensing element.
  • the membrane element 117 of the first part 110 covers at least part of the outer surface of the distal disk surface 115 of the first part 110 , and the constricting area 118 of the membrane element 117 is at least partially fixed in the distal converging element 113 of the first part 110 .
  • the film member 117 on the first portion 110 further covers the edge 116 of the first portion 110 .
  • the film member 117 on the first portion 110 may also cover the proximal disk surface 114 of the first portion 110 , that is, the film member 117 covers the distal disk surface 115 of the first portion 110 . , rim 116 and proximal disc 114 .
  • the distal constrictor 113 of the first portion 110 includes an inner sleeve 1131 and an outer sleeve 1132 that are arranged from the inside to the outside, and the proximal end of the inner sleeve 1131
  • the proximal end of the inner sleeve 1131 and the proximal end of the outer sleeve 1132 are enclosed to form the proximal inlet 1133 of the distal constrictor 113
  • the distal end of the inner sleeve 1131 and the distal end of the outer sleeve 1132 are enclosed to form a distal constriction
  • the distal entrance 1134 of the member 113, and the distal ends of the plurality of braided wires 111 of the first portion 110 are received or fixed between the inner sleeve 1131 and the outer sleeve 1122 after passing through the distal entrance 1134 of the distal constriction member 113
  • the distal ends of the plurality of braided wires 111 of the first portion 110 are received or fixed between the inner sleeve 1131 and the outer sleeve 1122 after passing through the proximal entrance 1133 of the distal constrictor 113 .
  • the gathering region 118 of the thin film member 117 passes through the distal gathering member 113 .
  • the proximal inlet 1133 or the distal inlet 1134 is at least partially received or fixed between the inner cannula 1131 and the outer cannula 1122.
  • the gathering region 118 of the membrane 117 passes through the distal end of the distal gather 113 .
  • the inlet 1134 is at least partially received or fixed between the inner sleeve 1131 and the outer sleeve 1122 .
  • Embodiment 4 The same parts of the occlusion device of Embodiment 4 as those of Embodiment 3 will not be repeated here.
  • the main difference between the two is that the distal constrictor 113 of the first part 110 described in Embodiment 3 can also be used for the second part. 120 of the distal beamer 123.
  • the thin film member 124 of the second portion 120 covers at least part of the outer surface of the distal disk surface 128 of the second portion 120 , and the converging region 125 of the thin film member 124 is at least partially fixed at the distal end of the second portion 120 to converge 123.
  • the film member 124 on the second portion 120 may further cover the edge 127 of the second portion 120 , that is, the space between the proximal disk surface 126 and the distal disk surface 128 of the second portion 120 . side part.
  • the film member 124 on the second portion 120 may also cover the proximal disk surface 126 of the second portion 120 , that is, the film member 124 covers the distal disk surface 128 and the edge 127 of the second portion 120 . and proximal disc 126 .
  • the above-mentioned various specific structures of the distal end constricting member 113 provided on the first part 110 in Embodiment 3, as well as the multiple accommodating and fixing distal ends of the plurality of braided wires and the constricting area 118 of the film member 117 This specific manner is also applicable to the distal end constricting member 123 on the second portion 120, and details are not described herein again.
  • the membrane element 117 on the first part 110 also covers the extension element 119, and the extension element 119 stretches the membrane element 117 radially outwards after being unfolded.
  • the extension member 119 is a plurality of semi-circular wires disposed on the edge 116 of the first portion 110 , and both ends of the wires are fixed on the edge 116 of the first portion 110 .
  • the plurality of filaments may be uniformly distributed along the edge 116 of the first portion 110 .
  • two adjacent wires may be spaced apart by a certain distance or abutted against each other.
  • the wire may be formed by a portion of a plurality of braided wires 111 woven into the first portion 110 protruding outward from the edge 116 of the first portion 110 .
  • the wire may be a separate component, and the two ends of the wire may be respectively fixed at appropriate positions on the edge 116 of the woven first portion 110, and may be semi-circular.
  • the extension 119 may also have other shapes or structures, as long as the extension 119 expands and spreads the membrane 117 radially outward when the first portion 110 is released, so that the membrane 117 is flat on the outer surface of the first portion 110 It can be unfolded to avoid folds on the disc surface and prone to thrombosis.
  • extension member 119 may also be disposed on the edge 127 of the second portion 120 , and the structure and function thereof are the same, which will not be repeated here.
  • the constricting member in Example 6 includes an inner sleeve that is hollow and sleeved in sequence from the inside to the outside. tube, intermediate casing and outer casing.
  • the beamer located at the proximal end of the first portion 110 is referred to as the proximal beamer 112
  • the beamer located at the distal end of the first portion 110 is referred to as the distal beamer 123 .
  • the proximal ends of the plurality of braided filaments 111 of the first part 110 and the constricting region 118 of the film element 117 are at least partially received and fixed in the proximal converging element 112 of the first part 110 .
  • the outer sleeve and the intermediate sleeve are also fixed together.
  • the inner sleeve and the outer sleeve can be directly or indirectly fixed together, or the inner sleeve and the intermediate sleeve can be directly or indirectly fixed together by various methods such as protrusions and grooves, or protrusions and through holes.
  • a relatively stable proximal constrictor 112 is formed.
  • the specific structures and matching methods are not limited, and will not be listed one by one here.
  • the distal end constrictor 113 of the first part 110 may be a hollow sleeve for receiving and fixing the distal ends of the plurality of braided wires 111 inside the sleeve.
  • the distal constrictor 113 of the first part 110 may also have the same structure as the proximal constrictor 112 of the first part 110 , that is, it includes an inner sleeve that is both hollow and sleeved sequentially from the inside to the outside.
  • an intermediate sleeve and an outer sleeve for receiving and fixing the distal ends of the plurality of braided wires 111 between the inner sleeve and the intermediate sleeve of the distal constrictor 113 , or between the intermediate sleeve and the outer sleeve.
  • the proximal disk surface 114 and the edge 116 of the first part 110 are covered with a film member 117 , and the film member 117 may be one or more layers.
  • a portion of the constricting region 118 of the membrane member 117 is fixed in the proximal converging member 112 of the first portion 110 , specifically, the inner sleeve 2121 and the intermediate sleeve 2122 that are clamped in the proximal converging member 112 Thereby, they are fixed therebetween, thereby ensuring that the proximal end of the first part 110 has a sufficiently good sealing performance, and at the same time, the constricting area 118 of the thin film member 117 is firmly fixed by the constricting member 112 at the proximal end.
  • portions of the membrane member 117 may be sutured to the proximal disk surface 114 of the first portion 110, or bonded to the proximal disk surface 114 of the first portion 110 with an adhesive.
  • the edge of the film member 117 covers the edge 116 of the first part 110 , which can reduce the damage to the body tissue caused by the edge 116 of the first part 110 .
  • the edge of the film member 117 can be fixed on the braided wire 111 at the edge 116 by sewing thread, or fixed at the edge 116 by means of adhesive bonding or the like.
  • the proximal ends of the plurality of braided wires 111 on the first part 110 are fixed between the middle sleeve 2122 and the outer sleeve 2123 of the proximal constrictor 112, and the fixing method can be clamped and fixed by the middle sleeve 2122 and the outer sleeve 2123, Either the proximal ends of the braided wires 111 are fixed between the middle sleeve 2122 and the outer sleeve 2123 by welding or the like, or the proximal ends of the braided wires 111 are welded and fixed to the distal end of the outer sleeve 2123 , the fixed method is not limited.
  • the membrane member 117 can be a complete circular membrane without obvious openings 1171 thereon. After the film member 117 is sandwiched between the inner sleeve 2121 and the middle sleeve 2122 of the proximal constricting member 112, the distal opening 2124 of the inner sleeve 2121 is covered by the most central part of the film member 117, thereby blocking The distal opening 2124 of the inner sleeve 2121 is formed to prevent blood flow from flowing into the interior of the first part 110 through the inner sleeve 2121, thereby improving the sealing performance of the occlusion device.
  • the inner wall of the inner sleeve 2121 of the proximal constricting member 112 of the first part 110 is provided with a thread 1124 or a clip, which can cooperate with the distal end of the delivery wire cable to realize a detachable connection, so as to achieve a detachable connection at the first part 110
  • the proximal cuff 112 can be used for the purpose of delivering the occlusion device when connected to the delivery wire, and for the purpose of completely releasing the occlusion device and recovering the delivery wire when disconnected.
  • the inner wall of the inner sleeve 2121 of the constraining member may not be provided with the thread 1124 or the clamping member.
  • the portion of the proximal disk surface 114 of the first portion 110 close to the proximal condensing member 112 is approximately tapered around the outer sleeve 2123 , so this portion is not perpendicular to the central axis of the proximal concentrating member 112 .
  • at least a portion of the proximal disk surface 114 of the first portion 110 that is close to the proximal condensing member 112 is perpendicular to the central axis of the proximal concentrating member 112 , so as to form a relatively small portion near the proximal concentrating member 112 .
  • the flat disk surface avoids the risk of thrombus formation near the proximal constrictor 112 and improves safety.
  • the proximal end of the middle sleeve 2122 is flush with the proximal end of the inner sleeve 2121 and the proximal end of the outer sleeve 2123 respectively, and the distal end of the outer sleeve 2123 is flush with the distal end of the inner sleeve 2121 Flush, the length of the middle sleeve 2122 is smaller than the length of the outer sleeve 2123 and the inner sleeve 2121, the proximal ends of the plurality of braided wires 111 are accommodated and fixed between the middle sleeve 2122 and the outer sleeve 2123, wherein the fixing point
  • the specific location and fixing method are not limited.
  • the cavity of the inner sleeve 2121 of the proximal constrictor 112 of the first part 110 is provided with a restricting member 1125 radially extending or having an included angle with the central axis of the inner sleeve 2121, and the two ends of the restricting member 1125 are respectively Pass through the tube wall of the inner sleeve 2121 to fix the restricting member 1125 and the inner sleeve 2121 together.
  • the limiting member 1125 can be used to limit the depth of the delivery wire cable extending into the inner sleeve 2121 when it is connected with the proximal end constricting member 112 , preventing the distal end of the delivery wire cable from poking at the distal end of the proximal end constricting member 112 .
  • the thin film member 117 on the end surface can be used to fix the thin film member 117 on the proximal end gathering member 112 to further enhance the stability of the thin film member 117 in the proximal end gathering member 112 .
  • Both ends of the restricting member 1125 further penetrate through the wall of the outer sleeve 2123 respectively, so as to fix the restricting member 1125 and the outer sleeve 2123 together, thereby also connecting the inner sleeve 2121 and the outer sleeve 2123 and relatively fixed.
  • the restricting member 1125 is a pin that penetrates through the tube wall of the inner sleeve 2121 and the outer sleeve 2123 of the proximal constricting member 112 , and the inner sleeve 2121 is provided with two opposite There are two opposite through holes on the wall of the outer sleeve 2123, and one end of the pin passes through the through hole 2125 of the outer sleeve 2123, the through hole 2126 of the inner sleeve 2121, the inner sleeve from the outside to the inside.
  • the through hole 2127 of the 2121 and the through hole 2128 of the outer sleeve 2123, the two ends of the final pin are respectively accommodated and fixed in the through hole 2125 and the through hole 2128 of the outer sleeve 2123.
  • the restricting member 1125 can also be other rod-shaped components, and both ends of the restricting member 1125 can also protrude from the wall of the outer sleeve 2123; After the tube wall of the tube 2123, the restriction on the movement of the restricting member 1125 in the radial direction is formed by the shape constraint.
  • the outer diameter in the axial direction may be larger than the diameter of the through hole on the wall of the outer sleeve 2123 for accommodating the restricting member 1125 .
  • the restricting member 1125 may not be provided in the proximal converging member 112 .
  • the restricting member 1125 only penetrates through the wall of the inner sleeve 2121 , and two ends of the restricting member 1125 are respectively received and fixed in the through holes 2126 and 2127 of the inner sleeve 2121 . Further, in one of the embodiments, as shown in FIG. 16 , the restricting member 1125 only penetrates through the wall of the inner sleeve 2121 , and the two ends of the restricting member 1125 extend from the through hole 2126 and the through hole 2127 of the inner sleeve 2121 respectively. The inner sleeve 2121 is clamped between the two ball heads, and the two ends of the restricting member 1125 pass through the film member 117 respectively, so that the film is also The part of the piece 117 close to the restriction piece 1125 is relatively fixed.
  • the proximal end of the proximal constricting member 112 is provided with an end cap 1126 connected to the inner sleeve 2121 , and the constricting region 118 of the membrane member 117 is at least partially accommodated or fixed between the end cap 1126 and the outer sleeve 2123 Thereby, the film member 117 is further stably fixed in the proximal end constricting member 112 .
  • the proximal end of the proximal constricting member 112 is provided with an end cap 1126 connected to the inner sleeve 2121 , and the constricting region 118 of the membrane member 117 is at least partially accommodated or fixed between the end cap 1126 and the outer sleeve 2123 Thereby, the film member 117 is further stably fixed in the proximal end constricting member 112 .
  • the length of the outer sleeve 2123 is the same as the length of the middle sleeve 2122 , and the length of the inner sleeve 2121 is greater than the length of the outer sleeve 2123 and the length of the middle sleeve 2122 .
  • the end cap 1126 may further press the membrane member 117 against the outer sleeve 2123 and/or the intermediate sleeve 2122.
  • the distal end of the proximal constrictor 112 may also be provided with an end cap 1126 connected to the outer sleeve 2123 or the inner sleeve 2121 , so as to further firmly fix the membrane 117 on the proximal constrictor 112 Inside, the opening at the distal end of the proximal constrictor 112 can also be blocked to improve the sealing performance.
  • the constricting area 118 of the thin film member 117 is provided with an opening 1171 as shown in FIG. .
  • the portion of the film member 117 enclosing the opening 1171 protrudes from the gap between the end cap 1126 and the outer sleeve 2123 and is fixed to the outer sleeve 2123 , the intermediate sleeve 2122 and the between end caps 1126.
  • the portion of the film member 117 enclosing the opening 1171 may further extend between the inner sleeve 2121 and the middle sleeve 2122 or between the middle sleeve 2122 and the outer sleeve 2123, and is annular Or tubular and clamped or clamped between two adjacent sleeves, as long as the proximal ends of the plurality of braided wires 111 are not affected to be fixed in the proximal constrictor 112 .
  • Such a membrane element 117 may be used in situations where it is desired that the distal opening 2124 of the proximal gather 112 be left unsealed.
  • the proximal constricting member 112 may not be provided with the restricting member 1125 or the end cap 1126, and the inner sleeve 2121 may not be provided with the thread 1124 or the clamping member.
  • the proximal end of the outer sleeve 2123 and the proximal end of the intermediate sleeve 2122 are enclosed to form the outer proximal inlet 221 of the proximal constrictor 112
  • the proximal end of the intermediate sleeve 2122 and The proximal end of the inner sleeve 2121 is enclosed to form the inner proximal inlet 222 of the proximal constrictor 112
  • the distal end of the outer sleeve 2123 and the distal end of the intermediate sleeve 2122 are enclosed to form a proximal constriction
  • the distal end of the intermediate sleeve 2122 and the distal end of the inner sleeve 2121 are encircled to form the inner distal entrance 224 of the proximal constrictor 112 .
  • the proximal ends of the plurality of braided wires 111 of the first portion 110 are accommodated or fixed between the outer sleeve 2123 and the intermediate sleeve 2122 .
  • the proximal ends of the plurality of braided wires 111 of the first portion 110 are received or fixed between the middle sleeve 2122 and the inner sleeve 2121 .
  • the proximal ends of the plurality of braided wires 111 of the first part 110 are received or fixed after passing through one of the outer proximal inlet 221 , outer distal inlet 223 , and inner distal inlet 224 of the proximal constrictor 112 . within the proximal band 112 .
  • the gather region 118 of the membrane element 117 passes through the proximal ends.
  • the inner proximal inlet 222 of the constrictor 112 is fixed at least partially between the inner sleeve 2121 and the intermediate sleeve 2122 , or between the outer sleeve 2123 , the intermediate sleeve 2122 and the end cap 1126 .
  • the gathering region 118 of the membrane member 117 passes through the outer side of the proximal gathering member 112 .
  • the proximal inlet 221 or the inner proximal inlet 222 is at least partially accommodated or fixed between two adjacent sleeves, or at least partially fixed between the outer sleeve 2123 , the middle sleeve 2122 and the end cap 1126 .
  • the gather region 118 of the membrane element 117 passes through the outer side of the proximal gatherer 112 .
  • Any one of the proximal inlet 221, the inner proximal inlet 222, and the outer distal inlet 223 is at least partially accommodated or fixed between the inner sleeve 2121 and the outer sleeve 2123, or at least partially fixed to the outer sleeve 2123, Between the intermediate sleeve 2122 and the end cap 1126 .
  • the inside of the first part 110 is further provided with at least one layer of blocking film, which is used to prevent blood from flowing into the inside of the first part 110 from the proximal disk surface 114 of the first part 110 , thereby further improving the blocking of the first part 110 performance.
  • Embodiment 7 The same parts of the occlusion device of Embodiment 7 as those of Embodiment 6 will not be repeated here.
  • the main difference between the two is that the proximal constrictor 112 or the distal constrictor of the first part 110 described in Embodiment 6 113 , which can also be used for the proximal converging member 122 or the distal converging member 123 of the second portion 120 .
  • the thin film member 124 of the second portion 120 covers at least part of the outer surface of the proximal disk surface 126 of the second portion 120 , and the converging region 125 of the thin film member 124 is at least partially fixed at the proximal end converging of the second portion 120 . inside part 122.
  • the film member 124 on the second part 120 may further cover the edge 127 of the second part 120 , that is, the side part between the proximal disk surface 126 and the distal disk surface 128 of the second part 120 .
  • the film member 124 on the second portion 120 may also cover the distal disk surface 128 of the second portion 120 , that is, the film member 124 covers the proximal disk surface 126 and the edge 127 of the second portion 120 . and distal disk 128 .
  • proximal end constricting member 112 provided on the first part 110 in Embodiment 6, as well as the above-mentioned various specific structures for receiving and fixing the proximal ends of the plurality of braided wires 111 and the constricting area 118 of the film member 117
  • Various specific manners are also applicable to the proximal-end constricting member 122 on the second portion 120 , and details are not described herein again.
  • Embodiment 8 The same parts of the occlusion device of Embodiment 8 as those of Embodiment 6 will not be repeated here, and the main difference between the two is that the proximal constrictor 112 described in Embodiment 6 can be disposed at the distal end of the first part 110 .
  • the distal condensing element 113 the features of the two are the same or similar in structure, cooperating manner with the thin film element 117 , and fixing manner in the condensing element.
  • the membrane element 117 of the first part 110 covers at least part of the outer surface of the distal disk surface 115 of the first part 110 , and the constricting area 118 of the membrane element 117 is at least partially fixed in the distal converging element 113 of the first part 110 .
  • the thin film 117 on the first part 110 may further cover the edge 116 of the first part 110 .
  • the film member 117 on the first part 110 can also cover the proximal disk surface 114 of the first part 110 , that is, the film member 117 covers the distal disk surface 115 , the edge 116 and the proximal disk surface 114 of the first part 110 .
  • the distal constrictor 113 of the first part 110 includes an inner sleeve 2121 , an intermediate sleeve 2122 and an outer sleeve 2123 , which are all hollow and sleeved sequentially from the inside to the outside.
  • the proximal end of the outer sleeve 2123 and the proximal end of the intermediate sleeve 2122 are enclosed to form the outer proximal inlet 221 of the distal constrictor 113, the proximal end of the intermediate sleeve 2122 and the proximal end of the inner sleeve 2121.
  • the ends are enclosed to form the inner proximal inlet 222 of the distal constrictor 113 , and the distal end of the outer sleeve 2123 and the distal end of the intermediate sleeve 2122 are enclosed to form the outer distal end of the distal constrictor 113
  • the inlet 223 , the distal end of the intermediate sleeve 2122 and the distal end of the inner sleeve 2121 are enclosed to form the inner distal inlet 224 of the distal constrictor 113 .
  • the distal ends of the plurality of braided wires 111 of the first part 110 are received or fixed at the distal end after passing through one of the outer proximal end inlet 221 , the inner proximal end inlet 222 , and the outer distal end inlet 223 of the distal end gatherer 113 in the bundler 113 .
  • the constricting region 118 of the membrane member 117 passes through the distal end of the converging member 113.
  • the outer distal inlet 223 or inner distal inlet 224 of the end restraint 113 is at least partially accommodated or fixed between two adjacent sleeves.
  • any one of the proximal inlet 221 , the outer distal inlet 223 and the inner distal inlet 224 is at least partially accommodated or fixed between two adjacent cannulas.
  • the gathering region 118 of the membrane 117 passes through the inner side of the distal gather 113 .
  • the distal inlet 224 is at least partially received or fixed between the inner cannula 2121 and the intermediate cannula 2122 .
  • Embodiment 9 The same parts of the occlusion device of Embodiment 9 as those of Embodiment 8 will not be repeated here.
  • the main difference between the two is that the distal constrictor 113 of the first part 110 described in Embodiment 8 can also be used for the second part. 120 of the distal beamer 123.
  • the thin film member 124 of the second portion 120 covers at least part of the outer surface of the distal disk surface 128 of the second portion 120 , and the converging region 125 of the thin film member 124 is at least partially fixed at the distal end of the second portion 120 to converge 123.
  • the film member 124 on the second part 120 may further cover the edge 127 of the second part 120 , that is, the side part between the proximal disk surface 126 and the distal disk surface 128 of the second part 120 .
  • the film member 124 on the second portion 120 may also cover the proximal disk surface 126 of the second portion 120 , that is, the film member 124 covers the distal disk surface 128 and the edge 127 of the second portion 120 . and proximal disc 126 .
  • the sealing disk used to block the opening in the body is generally woven into a network tube by braided wire, and both ends of the network tube need to be closed and fixed by a bolt head, and the bolt head is located at the end of the closed braided wire. After one end, it is often protruding from the disk surface of the sealing disk, so when the disk surface and the plug head are exposed to the blood flow, it is easy to form a thrombus at the plug head. After the thrombus flows into the human brain with the blood flow, it is easy to block the blood vessels. , induce stroke and endanger human health.
  • this embodiment provides a new, high-safety occlusion device for the problem that thrombus is easily formed due to the fact that the plug head protrudes from the disk surface of the sealing disc in the existing occlusion device, so that the occlusion device can be more Safely serve patients.
  • the occlusion device 300 of the tenth embodiment includes a first part 310 and a second part 320 connected to the first part 310 .
  • the first part 310 includes a plurality of braided wires 111 and a constricting member located relatively at the proximal end (ie, the proximal constricting member 112 ).
  • the proximal ends of the plurality of braided wires 111 are fixed to the proximal end constricting member 112 .
  • the first part 310 may further include a gatherer (ie, the distal gatherer 113 ) located opposite to the distal end, and the distal ends of the plurality of braided wires 111 are received and fixed in the distal gatherer 113 , so that the plurality of braided wires The distal end of 111 is fixed to the distal end constrictor 113 .
  • a gatherer ie, the distal gatherer 113
  • the plurality of braided filaments 111 of the first part 310 can be braided to form a mesh tube shape, and after heat-setting, the braided wires 111 can be shaped like a disc or a column.
  • the first portion 310 includes a proximal disk 114 and a distal disk 115 in the deployed state.
  • the proximal disk surface 114 of the first portion 310 is formed by cooperating with at least a portion of the plurality of braided filaments 111 of the first portion 310 located opposite to the proximal end.
  • the distal disk surface 115 of the first portion 310 is formed by cooperating with at least a portion of the plurality of braided filaments 111 of the first portion 310 located opposite to the distal ends.
  • the portion where the proximal disk surface 114 and the distal disk surface 115 of the first portion 310 are connected forms the edge 116 of the first portion 310 .
  • the proximal constrictor 112 of the first part 310 may be a hollow sleeve, may also be a double sleeve formed by an inner sleeve 1121 and an outer sleeve 1122 as described in any of the above embodiments, or may be an inner sleeve
  • the three-layer sleeve formed by the tube 2121 , the middle sleeve 2122 and the outer sleeve 2123 has the same or similar technical features as the structure and the method of bundling the braided wire 111 , and will not be repeated here.
  • the structure of the distal converging member 113 of the first part 310 is not limited, and can be any one of the aforementioned hollow casing, double casing, and three-layer casing.
  • the distal constrictor 113 of the first part 310 is directly connected to the proximal end of the second part 320 without a connecting piece between the first part 310 and the second part 320;
  • the second part 320 includes a plurality of The support rod 321 is supported, and the proximal end of the support rod 321 is fixed on the distal end constrictor 113 of the first part 310;
  • the support rod 321 is provided with anchor barbs 322, which are used to strengthen the anchor of the second part 320 after penetrating the body tissue Fixed stability.
  • the distal gather 113 of the first portion 310 may be disposed within the proximal gather of the second portion 320 and fixedly connected, thereby connecting the first portion 310 and the second portion 320 .
  • the specific structure of the second part 320 is not limited, and can also be the second part 120 described in Embodiment 1 in other embodiments.
  • the converging area 318 of the first part 310 refers to a part along the radial direction of the first part 310 , close to the central axis of the first part 310 , and the covered area may be centered on the central axis of the first part 310 and having a radius of the first part 310 An area in the range 1/4 to 1/2 of the radius.
  • the gathered region 318 of the first portion 310 includes a gathered portion formed by a portion of the plurality of braided filaments 111 through shape convergence.
  • the gathered portion includes a first gathered portion 311 and a second gathered portion 312 , and a part of the outer surface of the gathered portion forms a part of the proximal disk surface 114 .
  • the first gathering portion 311 and the second gathering portion 312 approach each other when no external force acts, so as to enclose the proximal gather 112 of the first portion 310 within the first portion 310 by the first gathering portion 311 and the second gathering portion 312 within the enclosed space.
  • the proximal constrictor 112 of the first part 310 is closer to the proximal end than the proximal disk surface 114 , that is, the proximal constrictor 112 protrudes from the proximal disk surface 114 toward the proximal end, and the existing constrictor is easily retracted at the proximal end. risk of thrombus formation at the bundle 112 .
  • the sheath is retracted towards the proximal end to The occlusion device 300 is released by self-expanding after releasing the radial restraint given by the sheath.
  • the edge part of the distal disk surface 115 of the first part 310 abuts on the tissue at the opening of the left atrial appendage, thereby blocking the opening of the left atrial appendage.
  • the distal end of the delivery wire 400 is still connected to the first portion 310
  • the proximal end receiving member 112 is connected, and the connection method can be screw connection, which is not limited here.
  • the first gathering portion 311 and the second gathering portion 312 move away from each other under the action of the external force provided by the distal end portion of the conveying wire cable 400 .
  • the opposite portions of the first gathering portion 311 and the second gathering portion 312 centered on the distal end portion of the delivery wire cable 400 abut on the distal end portion of the delivery wire cable 400 , which faces away from the proximal end.
  • FIG. 20B for a cross-sectional view when viewed from the end.
  • FIG. 21B a cross-sectional view when viewed from the proximal end to the distal end.
  • the space enclosed by the second gathering portion 312 is, specifically, enclosed between the proximal disk surface 114 and the distal disk surface 115 of the first portion 310 .
  • the proximal disk surface 114 is flat and closed, so after the occlusion device 300 is completely released, under the continuous scouring of blood flow, it is not easy to form a thrombus at the proximal disk surface 114 of the first part 310, which improves the safety of the operation. sex.
  • the maximum outer diameter of the gap is less than or equal to 5 mm, preferably less than or equal to 3 mm.
  • the size of the gap is generally smaller than the size of the mesh of the woven mesh formed by the plurality of braided wires 111 or smaller than the inner diameter of the above-mentioned inner sleeve.
  • the proximal disk surface 114 formed by the cooperation of a part of the outer surfaces of the first converging portion 311 and the second converging portion 312 is still closed.
  • a closure member may be provided at the gap, so that the first gathering portion 311 and the second gathering portion 312 are separated from each other.
  • the proximal disc 114 formed by 312 is closed.
  • the closure can be a jelly such as an embolic agent, which is characterized in that the shape is relatively stable after solidification and is not easily penetrated by liquid; after the conveying wire 400 is disconnected from the first part 310, the embolic agent can be injected into the first gathering part 311. The space enclosed by the second gathering portion 312 is filled, thereby ensuring that the proximal disk surface 114 is closed.
  • the closure may also be a compressible and self-expandable cover attached to the first portion 310, thus covering the gap after the cover is deployed, also ensuring that the proximal disc 114 is closed.
  • the closure member may also be a component of other structures, and the structure is not limited, as long as the proximal disk surface 114 can be closed, which will not be listed one by one here.
  • it is easy to thrombus, and the formed thrombus is not easy to overflow from the gap, and will stably exist in the space, thereby filling the space, so that the The disk is closed.
  • the specific shape, number and specific arrangement position of the gathering portion on the first part 310 are not limited, as long as the gathering portion can be in a natural state or after the external force is removed, the proximal constricting member 112 or the distal constrictor 113 surrounds the inner side of the first portion 310, so as to avoid the risk that the proximal constrictor 112 or the distal constrictor 113 protrudes outside the first portion 310 to easily induce thrombosis.
  • the gathered parts surrounding the proximal constrictor 112 or the distal constrictor 113 cooperate to form a flat and closed disk surface, the risk of thrombus formation easily induced by the outside of the first portion 310 can be completely avoided. It can be understood that the relevant features of the gathering portion provided on the first part 310 can also be transferred to the second part 320 .
  • the occlusion device 300 also includes one or more layers of membrane member 117 disposed on the first portion 310 .
  • the membrane member 117 covers the proximal disk surface 114 and the rim 116 of the first portion 310, so that the membrane member 117 also covers the outer surface of the first gather 311 and the outer surface of the second gather 312.
  • the constricting region of the membrane element 117 is at least partially received or fixed within the proximal converging element 112 of the first portion 310 .
  • the technical features related to the thin film member 117 in this embodiment are the same as or similar to the related technical features of the thin film member 117 in Embodiment 1, and are not repeated here.
  • the membrane element 117 provided on the first part 310 can further improve its sealing performance and realize multi-layer sealing.
  • the film member 117 may not be provided on the first portion 310 , as long as the first gathering portion 311 and the second gathering portion 312 cooperate with each other to form a flat proximal disk surface 114 , the formation at the proximal disk surface 114 can be avoided. thrombus.
  • the film member 117 covers part of the outer surface of the first gathering part 311 , or covers part of the outer surface of the second gathering part 312 , or covers part of the outer surface of the first gathering part 311 and the second gathering part 312 . .
  • first gathering portion 311 and the second gathering portion 312 are not limited, as long as they are close to each other so that the formed proximal disk surface 114 has a closed shape and a flat surface.
  • first gathering portion 311 includes a convex portion 313 and a concave portion 314
  • second gathering portion 312 includes a concave portion 315 and a convex portion 316 ; the first gathering portion After 311 and the second gathering portion 312 are approached, the convex portion 313 of the first gathering portion 311 abuts against the concave portion 315 of the second gathering portion 312 , and the concave portion 314 of the first gathering portion 311 abuts against the convex portion 315 of the second gathering portion 312 .
  • the raised portion 316 enables the first converging portion 311 and the second converging portion 312 to fit more fully and more easily to form a relatively flat proximal disk surface 114 to avoid thrombus formation at the proximal disk surface 114 .
  • the first gathering portion 311 includes a plurality of convex portions 313 and a plurality of concave portions 314
  • the second gathering portion 312 includes a plurality of concave portions 315 and a plurality of convex portions 316
  • the first gathering portion 311 After approaching the second gathering portion 312 , the protruding portions 313 of the first gathering portion 311 abut one of the concave portions 315 of the second gathering portion 312 respectively, and the plurality of concave portions 314 of the first gathering portion 311 respectively abut A raised portion 316 of the second gathering portion 312 .
  • the first gathering portion 311 abuts against the second gathering portion 312 , the proximal disk surface 114 of the first portion 310 is closed, and the proximal gathering member 112 of the first portion 310 is closed inside the first portion 310 .
  • the first gathers 311 and the second gathers 312 partially overlap in the axial direction and also partially overlap in the radial direction. In order to ensure that the formed proximal disk surface 114 is closed, after the first gathering portion 311 and the second gathering portion 312 are close to each other, they are at least abutted with each other in the radial direction.
  • first gathering portion 311 there may be a plurality of raised portions 313 of the first gathering portion 311 abutting against one of the concave portions 315 of the second gathering portion 312, and the first gathering portion 311 and the second gathering portion 312 can also be mutually Abut.
  • the first portion 310 is further provided with a restoring member, and after the first gathering portion 311 and the second gathering portion 312 are released from the external force, the restoring member aligns the first gathering portion 311 and the second gathering portion 312 with each other. gather.
  • the reset member 317 includes a magnet 3171 and a magnet 3172 with opposite magnetic properties. The number of magnets with the same magnetism and the specific installation positions are not limited. For example, magnets can also be arranged on the proximal condensing member 112 of the first portion 310 to be adsorbed and arranged on the first gathering portion 311 and/or the second gathering portion 311. magnet on part 312.
  • the first gathering portion 311 and the second gathering portion 312 are then gathered together under the mutual attraction of the two magnets after the force of the conveying wire 400 is released, so as to promote the first gathering portion 311 and the second gathering portion. 312 approach each other and eventually form a closed proximal disk 114 .
  • the reset member 318 includes a first reset lever 3181 disposed near the first gathering portion 311 and a second reset lever 3182 disposed near the second gathering portion 312 .
  • the first gathering portion 311 and the second gathering portion 312 are gathered together under the action of the first reset rod 3181 and the second reset rod 3182 .
  • one end of the first reset rod 3181 is fixed at the distal end of the proximal constrictor 112 of the first part 310 , and the other end protrudes from the distal end of the proximal constrictor 112 and then extends toward the proximal disk surface 114 , and is located at the The position close to the proximal disk surface 114 extends radially outward for a certain distance, and does not protrude from the edge 116 of the first portion 310; the second reset rod 3182 is symmetrically arranged with the first reset rod 3181 with the proximal constrictor 112 as the center .
  • first reset rod 3181 and the second reset rod 3182 are symmetrically arranged, and one end of the first reset rod 3181 is fixed at the distal end of the proximal constrictor 112 , and the other end is connected from the proximal constrictor 112
  • One end of the second reset rod 3182 is fixed at the distal end of the proximal constrictor 112, and the other end protrudes from the distal end of the proximal constrictor 112 and extends toward the first gathering part 311.
  • the second gathering portion 312 is curved and extended.
  • the first reset rod 3181 and the second reset rod 3182 are approximately straight in line with the deformation of the first part 310, and can be released from the sheath at the first part 310 Then, the above-mentioned shape is restored, so as to promote the first gathering portion 311 and the second gathering portion 312 to approach each other and finally form a closed proximal disk surface 114 .
  • the restoring member 319 includes an elastic coil connecting the first gathering portion 311 and the second gathering portion 312 .
  • the elastic coil has good elasticity and can be stretched radially outward when the delivery wire 400 is connected with the proximal constricting member 112, so as not to block the connection, nor to hinder the first gathering portion 311 and the second gathering portion 312 After the delivery wire 400 is disconnected from the proximal constricting member 112, the first gathering portion 311 and the second gathering portion 312 can be gathered together under the contraction action of the elastic coil.
  • One or more of such elastic coils can be provided as required.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Reproductive Health (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Surgical Instruments (AREA)
  • Packaging Of Annular Or Rod-Shaped Articles, Wearing Apparel, Cassettes, Or The Like (AREA)

Abstract

本发明涉及一种封堵装置，包括第一部分和与第一部分连接的第二部分，第一部分或第二部分包括多根编织丝和收束件，多个编织丝的靠近多根编织丝的一端的部分配合形成一个盘面，封堵装置还包括薄膜件，薄膜件至少覆盖盘面的部分外表面，收束件包括均中空且套设的内套管和外套管，多根编织丝的一端和薄膜件的收束区域的至少一部分均固定于收束件。本发明还涉及一种封堵装置，包括第一部分，第一部分包括多根编织丝和收束件，多根编织丝的一端固定于收束件，第一部分具有至少一个盘面，多根编织丝的一部分通过形状收敛形成聚拢部，收束件位于聚拢部围合的空间内，且由聚拢部配合形成的至少一个盘面是平坦且封闭的。

Description

封堵装置 技术领域
本发明涉及介入医疗器械技术领域，尤其涉及一种用于封堵体内开口的封堵装置。
背景技术
左心耳封堵器、房间隔缺损封堵器、动脉瘤封堵器等封堵装置，由于其结构实现封堵的优异性，以及植入患者体内后几乎不存在会危及生命的并发症等特点，越来越多地受到医生和患者的信赖，因此，如何不断改进封堵器结构，以便使其更好的服务于患者显得尤为重要。
发明内容
基于此，本发明旨在提供一种可更好服务于患者的封堵装置。
一种封堵装置，包括第一部分和与所述第一部分连接的第二部分，所述第一部分或所述第二部分包括多根编织丝和收束件，所述多个编织丝的靠近所述多根编织丝的一端的部分配合形成一个盘面，所述封堵装置还包括薄膜件，所述薄膜件至少覆盖所述盘面的部分外表面，所述收束件包括均中空且套设的内套管和外套管，所述多根编织丝的一端和所述薄膜件的收束区域的至少一部分均固定于所述收束件。
在其中一个实施例中，所述薄膜件的收束区域设有开孔，且所述薄膜件的围合形成所述开孔的部分收容并固定在所述收束件内。
在其中一个实施例中，所述收束件的一端设有与所述内套管连接的端盖，所述薄膜件的收束区域至少部分地收容或固定在所述端盖与所述外套管之间。
在其中一个实施例中，所述盘面的至少靠近所述收束件的部分与所述收束件的中轴线垂直。
在其中一个实施例中，所述内套管的内壁上设有螺纹或卡接件。
在其中一个实施例中，所述内套管的腔体内设有径向延伸或与所述内套管的中心轴具有夹角的限制件。
在其中一个实施例中，所述第一部分或所述第二部分还包括位于其边沿的延伸件，所述薄膜件还覆盖所述延伸件，所述延伸件在展开后径向向外撑开所述薄膜件。
在其中一个实施例中，所述内套管的近端端部和所述外套管的近端端部围合形成所述收束件的近端入口，所述内套管的远端端部和所述外套管的远端端部围合形成所述收束件的远端入口，且所述多根编织丝的一端在通过所述收束件的所述近端入口或所述远端入口后，固定于所述内套管和所述外套管之间。
在其中一个实施例中，所述收束件设置在所述第一部分或所述第二部分的近端，所述多根编织丝的一端为近端，当所述多根编织丝的近端是通过所述收束件的所述近端入口被接收和固定时，所述薄膜件的收束区域经由所述收束件的所述近端入口而至少部分地固定在所述内套管和所述外套管之间；或者，当 所述多根编织丝的近端是通过所述收束件的所述远端入口被接收和固定时，所述薄膜件的收束区域经由所述收束件的所述近端入口或所述远端入口而至少部分地收容或固定在所述内套管和所述外套管之间。
在其中一个实施例中，所述收束件设置在所述第一部分或所述第二部分的远端，所述多根编织丝的一端为远端，当所述多根编织丝的远端是通过所述收束件的所述近端入口被接收和固定时，所述薄膜件的收束区域经由所述收束件的所述近端入口或所述远端入口而至少部分地收容或固定在所述内套管和所述外套管之间；或者，当所述多根编织丝的远端是通过所述收束件的所述远端入口被接收和固定时，所述薄膜件的收束区域经由所述收束件的所述远端入口而至少部分地收容或固定在所述内套管和所述外套管之间。
在其中一个实施例中，所述收束件还包括中空且套设于所述内套管和所述外套管之间的中间套管。
在其中一个实施例中，所述多根编织丝的一端收容或固定于所述外套管和所述中间套管之间，或者，收容或固定于所述中间套管和所述内套管之间。
在其中一个实施例中，所述外套管的近端端部和所述中间套管的近端端部围合形成所述收束件的外侧近端入口，所述中间套管的近端端部和所述内套管的近端端部围合形成所述收束件的内侧近端入口，所述外套管的远端端部和所述中间套管的远端端部围合形成所述收束件的外侧远端入口，所述中间套管的远端端部和所述内套管的远端端部围合形成所述收束件的内侧远端入口；所述收束件设置在所述第一部分或所述第二部分的近端，所述多根编织丝的一端为近端，所述多根编织丝的一端在通过所述外侧近端入口、所述外侧远端入口、所述内侧远端入口中的其中一个后，收容或固定于所述收束件。
在其中一个实施例中，所述外套管的近端端部和所述中间套管的近端端部围合形成所述收束件的外侧近端入口，所述中间套管的近端端部和所述内套管的近端端部围合形成所述收束件的内侧近端入口，所述外套管的远端端部和所述中间套管的远端端部围合形成所述收束件的外侧远端入口，所述中间套管的远端端部和所述内套管的远端端部围合形成所述收束件的内侧远端入口；所述收束件设置在所述第一部分或所述第二部分的远端，所述多根编织丝的一端为远端，所述多根编织丝的一端在通过所述外侧近端入口、所述内侧近端入口、所述外侧远端入口中的其中一个后，收容或固定于所述收束件。
一种封堵装置，包括第一部分，所述第一部分包括多根编织丝和收束件，所述多根编织丝的一端固定于所述收束件，所述第一部分具有至少一个盘面，所述多根编织丝的一部分通过形状收敛形成聚拢部，所述收束件位于所述聚拢部围合的空间内，且由所述聚拢部配合形成的至少一个所述盘面是平坦且封闭的。
在其中一个实施例中，所述聚拢部包括第一聚拢部和第二聚拢部，所述第一聚拢部和所述第二聚拢部在无外力作用时相互靠近，以将所述收束件包围在所述第一聚拢部和所述第二聚拢部围合的空间内；所述第一聚拢部和所述第二聚拢部在外力作用下可相互远离。
在其中一个实施例中，所述第一聚拢部和所述第二聚拢部相互靠近后形成 的间隙的最大外径小于或等于5毫米；或者，所述第一聚拢部和所述第二聚拢部相互靠近且至少在径向方向上相互贴合。
在其中一个实施例中，所述第一聚拢部和所述第二聚拢部形成的间隙处设有封闭件，以使由所述聚拢部配合形成的至少一个所述盘面是封闭的。
在其中一个实施例中，所述第一聚拢部包括至少一个凸起部，所述第二聚拢部包括至少一个凹陷部，所述第一聚拢部和所述第二聚拢部相互靠近后，至少一个所述凸起部抵接于一个所述凹陷部。
在其中一个实施例中，所述第一部分还设有复位件，所述第一聚拢部和所述第二聚拢部在外力作用解除后，所述复位件将所述第一聚拢部和所述第二聚拢部相互聚拢。
在其中一个实施例中，所述复位件包括磁性相反的至少两个磁铁，所述第一聚拢部和所述第二聚拢部在所述至少两个磁铁的作用下相互聚拢。
在其中一个实施例中，所述复位件包括靠近所述第一聚拢部设置的第一复位杆和靠近所述第二聚拢部设置的第二复位杆，所述第一聚拢部和所述第二聚拢部在所述第一复位杆和所述第二复位杆的作用下相互聚拢。
在其中一个实施例中，所述复位件包括连接所述第一聚拢部和所述第二聚拢部的至少一个弹性线圈，所述第一聚拢部和所述第二聚拢部在所述弹性线圈的作用下相互聚拢。
在其中一个实施例中，所述封堵装置还包括薄膜件，所述薄膜件至少覆盖所述聚拢部的部分外表面。
上述封堵装置效果如下：
上述封堵装置中，采用在第一部分的盘面上设置薄膜件，以提高第一部分的密封性，同时采用包括内套管和外套管的收束件来收束和固定编织构成第一部分的多根编织丝的端部，并通过该收束件来收容和固定薄膜件的收束区域的部分，从而将薄膜件的该部分稳固地固定在第一部分上，使薄膜件在第一部分上不容易发生移动或脱落。
上述封堵装置中，第一部分上设置有通过多根编织丝的一部分经过形状收敛形成的聚拢部，同时，由于聚拢部配合形成的盘面是平坦且封闭的，因而，聚拢部能够将收束件包围在由聚拢部围合的空间内，使得收束件不会凸出于位于第一部分外围的盘面，避免了血流在收束件附近形成血栓，提高了封堵装置的安全性。
附图说明
图1为实施例1的封堵装置的其中一种整体结构示意图；
图2为实施例1中第一部分的其中一种结构示意图；
图3为图2中圆形虚线部分的放大结构示意图；
图4为实施例1中第一部分的另一种结构示意图；
图5为实施例1中第一部分的另一种结构示意图；
图6为图5中圆形虚线部分的放大结构示意图；
图7为实施例1中第一部分的另一种结构示意图；
图8为图7中圆形虚线部分的放大结构示意图；
图9为实施例1中第一部分的另一种结构示意图；
图10为图9中圆形虚线部分的放大结构示意图；
图11为实施例1中设有开孔的薄膜件的展开结构示意图；
图12为实施例3中第一部分的其中一种结构示意图；
图13为图12中圆形虚线部分的放大结构示意图；
图14为实施例5中第一部分近端处的展开结构示意图；
图15为实施例6中第一部分的其中一种结构示意图；
图16为图15中圆形虚线部分的另一实现方式的放大结构示意图；
图17为图15中圆形虚线部分的另一实现方式的放大结构示意图；
图18为实施例6中收束件的其中一种结构示意图；
图19为实施例10中封堵装置的其中一种整体结构示意图；
图20A为实施例10中封堵装置植入到体内组织且与输送钢缆连接时的结构示意图；
图20B为图20A中第一部分的纵向截面示意图；
图21A为实施例10中封堵装置植入到体内组织且与输送钢缆断开连接时的结构示意图；
图21B为图21A中第一部分的纵向截面示意图；
图22为实施例10中第一部分的另一种结构示意图；
图23为实施例10中第一部分的另一种结构示意图；
图24为实施例10中第一部分的另一种结构示意图；
图25为实施例10中第一部分的另一种结构示意图。
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。
需要说明的是，在介入医疗器械领域，一般将植入人体或动物体内的医疗器械的距离操作者较近的一端称为“近端”，将距离操作者较远的一端称为“远端”，并依据此原理定义医疗器械的任一部件的“近端”和“远端”。“轴向”一般是指医疗器械在被输送时的长度方向，“径向”一般是指医疗器械的与其“轴向”垂直的方向，并依据此原理定义医疗器械的任一部件的“轴向”和“径向”。
本申请中，相对位于近端的收束件被称为近端收束件，相对位于远端的收束件被称为远端收束件。同理，相对位于近端的盘面被称为近端盘面，相对位于远端的盘面被称为远端盘面。以下将结合具体实施例进一步详细说明本发明的技术方案。
众所周知，密封盘的密封性是成功实现体内开口被封堵的关键因素之一。而现有封堵器的密封盘，仅仅采用通过编织丝编织成的网管在热定型后形成的盘面进行封堵。要想实现密封盘具有良好的密封性能，则需要将密封盘的 编织丝编织的更密集些，因而需要的编织丝会多一些，导致密封盘收容在鞘管后的外径较大，因而需要具有较大内径的鞘管配合。而在介入医疗器械领域，则需要鞘管的外径越小越好。因而，如何使密封盘具有更好的密封性，同时能使所需的鞘管外径更小，这是密封盘在设计时的一个难题。鉴于此，本发明示例性的提供如下实施例1～9所示的封堵装置，以解决上述难题，使其能更好的服务于患者。
实施例1
请参考图1所示的封堵装置100，该封堵装置100包括相对位于近端的第一部分110和相对位于远端的第二部分120，第一部分110的远端与第二部分120的近端直接连接，或者第一部分110的远端与第二部分120的近端通过至少一个连接件130间接连接，该连接件130可以是刚性的或者是柔性的。在一些实施例中，第一部分110可用于封堵体内组织的开口或孔，第二部分120可用于将封堵装置100固定在体内组织的腔体内，例如，封堵装置100用作封堵左心耳的开口的情况。进一步地，第二部分120也可用于封堵体内组织的开口或孔。在另一些实施例中，第一部分110和第二部分120均可用于封堵体内组织的开口或孔，例如，封堵装置100用作封堵房间隔或室间隔的开孔的情况，或者用于卵圆孔未闭的情况，此时，第一部分110和第二部分120相互配合从而将封堵装置100固定在体内组织开口或孔的附近。
第一部分110包括多根编织丝111和两个收束件112/113，其中，每根编织丝111均具有相对的近端和远端，多根编织丝111可被编织形成网管状，多根编织丝111也包括相对的近端和远端，并在热定型后呈现盘状或柱状等形状。因而，第一部分110至少包括一个近端盘面114和一个远端盘面115。第一部分110的近端盘面114由第一部分110的多根编织丝111的靠近该多根编织丝111的近端的部分配合形成。第一部分110的远端盘面115由第一部分110的多根编织丝111的靠近该多根编织丝111的远端的部分配合形成。第一部分110的近端盘面114和远端盘面115连接的部分，形成第一部分110的边沿116。
第一部分110的近端收束件112包括均中空且套设的内套管和外套管，多根编织丝111的近端收容并固定在内套管和外套管之间，从而使多根编织丝111的近端固定于近端收束件112。第一部分110的远端收束件113可以为一个中空的套管，用于将多根编织丝111的远端收容并固定在该套管内部，从而使多根编织丝111的远端固定于远端收束件113。在另一实施例中，第一部分110的远端收束件113也可以与第一部分110的近端收束件112的结构相同，即包括均中空且套设的内套管和外套管，用于将多根编织丝111的远端收容并固定在远端收束件113的内套管和外套管之间。
第二部分120的具体结构不限，只要能够将封堵装置100在释放后固定在体内组织的腔体内即可。例如，第二部分120可通过激光切割具有形状记忆特性的合金管并热定型后得到，也可以由多根编织丝111经过编织后热定型得到。第二部分120的远端部分可以为封闭的，也可以具有开口。本实施例中，第二部分120包括多根编织丝121和两个收束件122/123，其中，多根编织丝121可被编织形成柱状的编织网，编织网的近端被第二部分120的近端收束件122收 容和固定，编织网的远端被第二部分120的远端收束件123收容和固定。
第二部分120的近端收束件122可以包括均中空且套设的内套管和外套管，用于将第二部分120的多根编织丝121的近端收容并固定在该内套管和外套管之间。在另一实施例中，第二部分120的近端收束件122也可以为一个中空的套管，用于将第二部分120的多根编织丝121的近端收容并固定在该套管内部。
第二部分120的远端收束件123也可以为一个中空的套管，用于将第二部分120的多根编织丝121的远端收容并固定在该套管内部。在另一实施例中，第二部分120的远端收束件123也可以与第一部分110的近端收束件112的结构相同，即包括均中空且套设的内套管和外套管，用于将第二部分120的多根编织丝121的远端收容并固定在该内套管和外套管之间。
在其他实施例中，当第一部分110与第二部分120为一体成型的结构时，第一部分110的远端可以不设置远端收束件113，第二部分120的近端也可以不设置近端收束件122。
封堵装置100还包括薄膜件，薄膜件可设置在第一部分110和/或第二部分120。当薄膜件设置在第一部分110上时，薄膜件117至少覆盖第一部分110的近端盘面114的外表面，且薄膜件117的收束区域118至少部分地固定在第一部分110的近端收束件112内，从而保证了第一部分110的近端具有足够好的密封性，且同时通过近端收束件112将薄膜件117的收束区域118牢固地固定。在其他实施例中，薄膜件117覆盖第一部分110的近端盘面114的部分外表面，以根据需要有针对性地增强近端盘面114局部区域的密封性。在其他实施例中，第一部分110上的薄膜件117还可进一步覆盖第一部分110的边沿116。进一步地，在其他实施例中，第一部分110上的薄膜件117还可以覆盖第一部分110的远端盘面115，也即薄膜件117覆盖了第一部分110的近端盘面114、边沿116和远端盘面115。薄膜件117的收束区域118指的是薄膜件117的位于收束件附近的部分，收束件可位于薄膜件117的中心位置或其他位置；当薄膜件117被近端收束件112或远端收束件123固定时，薄膜件117的收束区域118可以是指薄膜件117的靠近相应的近端收束件112或远端收束件123的部分。同理可定义第二部分120上的薄膜件124的收束区域125。
薄膜件117可采用PET膜或PTFE膜制成，因而不仅具有良好的密封性，还能够在血流的冲击下促进薄膜件117上内皮爬附，从而进一步提高密封性。
如图1至图3所示，第一部分110的近端盘面114和边沿116上包覆有薄膜件117，薄膜件117可以为一层或多层。薄膜件117的收束区域118的一部分被固定在第一部分110的近端收束件112内，具体地，可以是被夹紧在该近端收束件112的内套管1121和外套管1122之间从而被固定，也可以是卡设在内套管1121和外套管1122上且在内套管1121和外套管1122连接在一起后而被相对固定。薄膜件117的其他部分可通过缝线缝在第一部分110的近端盘面114上，或通过粘结剂粘结在第一部分110的近端盘面114上。薄膜件117的边缘覆盖了第一部分110的边沿116，能够减少第一部分110的边沿116部分对体内组织造成的刮擦等损伤。薄膜件117的边缘可通过缝合线缝合到边沿116处的编织丝111上进行固定，或通过粘结剂粘结等方式固定在边沿116处。第一部分110上多 根编织丝111的近端被固定在近端收束件112的内套管1121和外套管1122之间，固定方式可以为由内套管1121和外套管1122夹紧固定，也可以为通过焊接等方式将多根编织丝111的近端固定在外套管1122的远端端部，固定方式不做限制。
薄膜件117可以为一个完整的圆形薄膜，其上未设有明显的开孔。薄膜件117夹设在近端收束件112的内套管1121和外套管1122之间后，内套管1121的远端开口1123被薄膜件117的最中心的一部分所覆盖，从而封堵了内套管1121的远端开口1123，以阻止血流通过内套管1121流入第一部分110的内部，提高了封堵装置100的密封性。
进一步地，第一部分110的近端收束件112的内套管1121的内壁上设有螺纹1124或卡接件，可与输送钢缆的远端配合实现可拆卸连接，以达到在第一部分110的近端收束件112与输送钢缆连接时可用于输送封堵装置100，以及在断开连接时彻底释放封堵装置100并回收输送钢缆的目的。在其他实施例中，收束件的内套管1121的内壁上可不设有螺纹1124或卡接件。
进一步地，第一部分110的近端收束件112的内套管1121的腔体内设有径向延伸或与内套管1121的中心轴具有夹角的限制件1125，既可以用来限制输送钢缆与近端收束件112连接时伸入内套管1121内部的深度，防止输送钢缆的远端戳到位于近端收束件112的远端端面上的薄膜件117，又可以用来将薄膜件117固定在近端收束件112上，以进一步增强薄膜件117在近端收束件112内的稳固性。本实施例中，限制件1125为穿设在近端收束件112的内套管1121的管壁和外套管1122的管壁上的插销，内套管1121的管壁上开设有两个相对的通孔，外套管1122的管壁上也开设有两个相对的通孔，插销的一端自外向内依次穿过外套管1122的通孔、内套管1121的通孔、内套管1121的通孔和外套管1122的通孔，最终插销的两端分别收容并固定在外套管1122的两个通孔内。在其他实施例中，限制件1125还可以为其他杆状的组件，限制件1125的两端也可向外伸出外套管1122的管壁；进一步地，限制件1125的两端在伸出外套管1122的管壁后，通过形状约束从而形成对限制件1125在径向方向上移动的限制，例如，将限制件1125的两端设成球头状或其他形状的凸起，只要凸起在轴向方向的外径大于外套管1122的管壁上用于收容限制件1125的通孔的直径即可。在其它实施例中，限制件1125仅贯穿内套管1121的管壁，且限制件1125的两端分别收容并固定在内套管1121的两个通孔内。在其他实施例中，近端收束件112内可不设有限制件1125。
本实施例中，第一部分110的近端盘面114的至少靠近近端收束件112的部分1141与该近端收束件112的中轴线垂直，从而在近端收束件112的附近形成较为平坦的盘面，以避免血栓在近端收束件112附近形成的风险，提高安全性。其中，平坦的盘面指的是，盘面的表面上没有明显凸出的部分，即使有若干凸出的部分，则这些凸出的部分相对于其他部分向外凸出的高度小于或等于2毫米。在其他实施例中，如图4所示，第一部分110的近端盘面114的至少靠近近端收束件112的部分1142可设置为不与该近端收束件112的中轴线垂直。
进一步地，在其他实施例中，如图4至图6所示，近端收束件112的近端 设有与内套管1121连接的端盖1126，薄膜件117的收束区域118至少部分地收容或固定在端盖1126与外套管1122之间，从而进一步将薄膜件117稳固地固定在近端收束件112内。第一部分110上多根编织丝111的近端从端盖1126和外套管1122之间的空隙伸入到内套管1121和外套管1122之间的空隙中，直至伸入到外套管1122的远端端部后，通过焊接等方式固定在近端收束件112的远端，具体地，作为其中一种实现方式，可固定在外套管1122的远端端部和内套管1121的远端端部之间。在其他实施例中，近端收束件112的远端也可设有与外套管1122或内套管1121连接的端盖1126，以进一步将薄膜件117稳固地固定在近端收束件112内，还可封堵近端收束件112远端的开口，提高密封性。
在图5和图6所示的实施例中，薄膜件117的收束区域118设有如图11所示的开孔1171，且薄膜件117的围合形成该开孔1171的部分收容并固定在近端收束件112内。具体地，薄膜件117的围合形成该开孔1171的部分从端盖1126和外套管1122之间的空隙伸入到内套管1121和外套管1122之间后，呈环形或管状而与多根编织丝111的一部分一起被夹紧在内套管1121和外套管1122之间。这种薄膜件117可用在需要近端收束件112的远端开口1123不被封闭的情况下，例如需要通过远端开口1123朝远端输送物质或组件等情况。在其他实施例中，端盖1126上可设有细槽，薄膜件117的围合形成该开孔1171的部分可固定夹设在端盖1126的细槽内，具体方式不限。在其他实施例中，近端收束件112内可不设有限制件1125或端盖1126，内套管1121内也可不设有螺纹1124或卡接件。
内套管1121的近端端部和外套管1122的近端端部围合形成近端收束件112的近端入口，内套管1121的远端端部和外套管1122的远端端部围合形成近端收束件112的远端入口，且第一部分110的多根编织丝111的近端在通过近端收束件112的近端入口或远端入口后，收容或固定在内套管1121和外套管1122之间。具体地，当第一部分110的多根编织丝111的近端是通过近端收束件112的近端入口被接收和固定时，如图3和图6所示，薄膜件117的收束区域118经由近端收束件112的近端入口1127而至少部分地固定在内套管1121和外套管1122之间。当第一部分110的多根编织丝111的近端是通过近端收束件112的远端入口1128被接收和固定时，如图7和图8所示，薄膜件117的收束区域118经由近端收束件112的远端入口1128而至少部分地收容或固定在内套管1121和外套管1122之间。在其他实施例中，当第一部分110的多根编织丝111的近端是通过近端收束件112的远端入口1128被接收和固定时，如图9和图10所示，薄膜件117的收束区域118经由近端收束件112的近端入口1127而至少部分地收容或固定在内套管1121和外套管1122之间。
在其他实施例中，第一部分110的内部还设有至少一层阻流膜，用于阻止血液从第一部分110的近端盘面114流入第一部分110的内部，从而进一步提高第一部分110的封堵性能。
实施例2
实施例2的封堵装置中与实施例1相同的部分在此不再赘述，两者的区别主要在于，实施例1所描述的第一部分110的近端收束件112或远端收束件113，同样可用于第二部分120。
具体地，与图1所示的结构近似，第二部分120的薄膜件124覆盖第二部分120的近端盘面126的外表面和边沿127，且薄膜件124的收束区域125至少部分地固定在第二部分120的近端收束件122内。第二部分120的边沿127，即第二部分120的近端盘面126和远端盘面128之间的侧面部分。进一步地，在其他实施例中，第二部分120上的薄膜件124还可进一步覆盖第二部分120的远端盘面128，也即薄膜件124覆盖了第二部分120的近端盘面126、边沿127和远端盘面128。在其他实施例中，第二部分120的薄膜件124仅覆盖第二部分120的近端盘面126的外表面或远端盘面128的外表面，或远端盘面128的外表面和边沿127。在其他实施例中，薄膜件124可覆盖近端盘面126或远端盘面128的部分外表面，以根据需要有针对性地增强近端盘面126或远端盘面128局部区域的密封性。在此基础上，实施例1中第一部分110上设置的近端收束件112的上述多种具体结构，以及收容和固定多根编织丝111的近端、薄膜件117的收束区域118的多种具体方式，同样适用于第二部分120上的近端收束件122，在此不再赘述。
实施例3
实施例3的封堵装置中与实施例1相同的部分在此不再赘述，两者的区别主要在于，实施例1所描述的近端收束件112可设置在第一部分110的远端而作为远端收束件113，两者的结构、与薄膜件117的配合方式、在收束件内的固定方式等特征均相同或近似。
具体地，第一部分110的薄膜件117至少覆盖第一部分110的远端盘面115的部分外表面，且薄膜件117的收束区域118至少部分地固定在第一部分110的远端收束件113内。在其他实施例中，第一部分110上的薄膜件117进一步覆盖第一部分110的边沿116。进一步地，在本实施例中，如图12所示，第一部分110上的薄膜件117还可以覆盖第一部分110的近端盘面114，也即薄膜件117覆盖了第一部分110的远端盘面115、边沿116和近端盘面114。
在其中一些实施例中，结合图12和图13所示，第一部分110的远端收束件113包括由内至外套设的内套管1131和外套管1132，内套管1131的近端端部和外套管1132的近端端部围合形成远端收束件113的近端入口1133，内套管1131的远端端部和外套管1132的远端端部围合形成远端收束件113的远端入口1134，且第一部分110的多根编织丝111的远端在通过远端收束件113的远端入口1134后，收容或固定在内套管1131和外套管1122之间。在其他实施例中，第一部分110的多根编织丝111的远端在通过远端收束件113的近端入口1133后，收容或固定在内套管1131和外套管1122之间。
具体地，当第一部分110的多根编织丝111的远端是通过远端收束件113的近端入口1133被接收和固定时，薄膜件117的收束区域118经由远端收束件113的近端入口1133或远端入口1134而至少部分地收容或固定在内套管1131和外套管1122之间。当第一部分110的多根编织丝111的远端是通过远端收束件113的远端入口1134被接收和固定时，薄膜件117的收束区域118经由远端收束件113的远端入口1134而至少部分地收容或固定在内套管1131和外套管1122之间。
实施例4
实施例4的封堵装置中与实施例3相同的部分在此不再赘述，两者的区别主要在于，实施例3所描述的第一部分110的远端收束件113同样可用于第二部分120的远端收束件123。
具体地，第二部分120的薄膜件124至少覆盖第二部分120的远端盘面128的部分外表面，且薄膜件124的收束区域125至少部分地固定在第二部分120的远端收束件123内。在图1所示的实施例中，第二部分120上的薄膜件124还可进一步覆盖第二部分120的边沿127，也即第二部分120的近端盘面126和远端盘面128之间的侧面部分。进一步地，在其他实施例中，第二部分120上的薄膜件124还可以覆盖第二部分120的近端盘面126，也即薄膜件124覆盖了第二部分120的远端盘面128、边沿127和近端盘面126。在此基础上，实施例3中第一部分110上设置的远端收束件113的上述多种具体结构，以及收容和固定多根编织丝的远端、薄膜件117的收束区域118的多种具体方式，同样适用于第二部分120上的远端收束件123，在此不再赘述。
实施例5
实施例5的封堵装置中与实施例1至实施例4相同的部分在此不再赘述，其区别主要在于，如图14所示，第一部分110还包括位于第一部分110边沿116的延伸件119，第一部分110上的薄膜件117还覆盖延伸件119，延伸件119在展开后径向向外撑开薄膜件117。本实施例中，延伸件119为设置在第一部分110边沿116的多根呈半环状的丝，丝的两端固定在第一部分110的边沿116上。多根丝沿着第一部分110的边沿116可均匀分布。进一步地，相邻两个丝之间可间隔一定距离或相互抵接。作为其中一种实施方式，丝可由编织制成第一部分110的多根编织丝111的一部分向外凸出第一部分110的边沿116形成。在其他实施方式中，丝可以为单独的组件，其两端可以被分别固定在已编织好的第一部分110的边沿116上的合适位置处，并呈半环状即可。延伸件119还可以具有其他形状或结构，只要能够在第一部分110被释放时，延伸件119展开并径向向外撑开薄膜件117，使得薄膜件117在第一部分110的外表面上平整地展开即可，避免盘面出现褶皱而容易产生血栓。
在其他实施例中，还可在第二部分120的边沿127设置上述延伸件119，其结构及作用相同，在此不再赘述。
实施例6
实施例6的封堵装置中与实施例1相同的部分在此不再赘述，两者的区别主要在于，实施例6中的收束件包括均中空且由内而外依次套设的内套管、中间套管和外套管。相对位于第一部分110近端的收束件被称为近端收束件112，相对位于第一部分110远端的收束件被称为远端收束件123。第一部分110的多根编织丝111的近端、薄膜件117的收束区域118均至少部分地收容并固定在第一部分110的近端收束件112内。
第一部分110的多根编织丝111的近端被固定在外套管和中间套管之间后，外套管与中间套管也被固定在一起。可通过凸起与凹槽，或凸起与通孔配合等各种方式，将内套管与外套管直接或间接固定在一起，或将内套管与中间套管 直接或间接固定在一起，从而构成一个结构相对稳定的近端收束件112。具体的结构以及配合方式不做限制，在此不再一一列举。
第一部分110的远端收束件113可以为一个中空的套管，用于将多根编织丝111的远端收容并固定在该套管内部。在另一实施例中，第一部分110的远端收束件113也可以与第一部分110的近端收束件112的结构相同，即包括均中空且由内而外依次套设的内套管、中间套管和外套管，用于将多根编织丝111的远端收容并固定在远端收束件113的内套管和中间套管之间，或者中间套管和外套管之间。
如图15所示，第一部分110的近端盘面114和边沿116上包覆有薄膜件117，薄膜件117可以为一层或多层。薄膜件117的收束区域118的一部分被固定在第一部分110的近端收束件112内，具体地，是被夹紧在该近端收束件112的内套管2121和中间套管2122之间从而被固定，从而保证了第一部分110的近端具有足够好的密封性，且同时通过近端收束件112将薄膜件117的收束区域118牢固地固定。薄膜件117的其他部分可通过缝线缝在第一部分110的近端盘面114上，或通过粘结剂粘结在第一部分110的近端盘面114上。薄膜件117的边缘覆盖了第一部分110的边沿116，能够减少第一部分110的边沿116部分对体内组织造成的损伤。薄膜件117的边缘可通过缝合线缝合到边沿116处的编织丝111上进行固定，或通过粘结剂粘结等方式固定在边沿116处。第一部分110上多根编织丝111的近端被固定在近端收束件112的中间套管2122和外套管2123之间，固定方式可以为由中间套管2122和外套管2123夹紧固定，或为通过焊接等方式将多根编织丝111的近端固定在中间套管2122和外套管2123之间，或是将多根编织丝111的近端焊接固定在外套管2123的远端端部，固定方式不做限制。
薄膜件117可以为一个完整的圆形薄膜，其上未设有明显的开孔1171。薄膜件117夹设在近端收束件112的内套管2121和中间套管2122之间后，内套管2121的远端开口2124被薄膜件117的最中心的一部分所覆盖，从而封堵了内套管2121的远端开口2124，以阻止血流通过内套管2121流入第一部分110的内部，提高了封堵装置的密封性。
进一步地，第一部分110的近端收束件112的内套管2121的内壁上设有螺纹1124或卡接件，可与输送钢缆的远端配合实现可拆卸连接，以达到在第一部分110的近端收束件112与输送钢缆连接时可用于输送封堵装置，以及在断开连接时彻底释放封堵装置并回收输送钢缆的目的。在其他实施例中，收束件的内套管2121的内壁上可不设有螺纹1124或卡接件。
本实施例中，第一部分110的近端盘面114的靠近近端收束件112的部分环绕外套管2123而呈近似锥形，因而该部分不与近端收束件112的中轴线垂直。在其他实施例中，第一部分110的近端盘面114的至少靠近近端收束件112的部分与该近端收束件112的中轴线垂直，从而在近端收束件112的附近形成较为平坦的盘面，以避免血栓在近端收束件112附近形成的风险，提高安全性。
中间套管2122的近端端部分别与内套管2121的近端端部和外套管2123的近端端部齐平，外套管2123的远端端部与内套管2121的远端端部齐平，中间 套管2122的长度均小于外套管2123和内套管2121的长度，多根编织丝111的近端被收容和固定在中间套管2122和外套管2123之间，其中，固定点的具体位置和固定方式不限。
进一步地，第一部分110的近端收束件112的内套管2121的腔体内设有径向延伸或与内套管2121的中心轴具有夹角的限制件1125，限制件1125的两端分别贯穿内套管2121的管壁，以将限制件1125与内套管2121固定在一起。该限制件1125既可以用来限制输送钢缆与近端收束件112连接时伸入内套管2121内部的深度，防止输送钢缆的远端戳到位于近端收束件112的远端端面上的薄膜件117，又可以用来将薄膜件117固定在近端收束件112上，以进一步增强薄膜件117在近端收束件112内的稳固性。限制件1125的两端进一步还分别贯穿外套管2123的管壁，以将限制件1125与外套管2123固定在一起，由此也将内套管2121和外套管2123连接起来并相对固定。
本实施例中，限制件1125为穿设在近端收束件112的内套管2121的管壁和外套管2123的管壁上的插销，内套管2121的管壁上开设有两个相对的通孔，外套管2123的管壁上也开设有两个相对的通孔，插销的一端自外向内依次穿过外套管2123的通孔2125、内套管2121的通孔2126、内套管2121的通孔2127和外套管2123的通孔2128，最终插销的两端分别收容并固定在外套管2123的通孔2125和通孔2128内。在其他实施例中，限制件1125还可以为其他杆状的组件，限制件1125的两端也可向外伸出外套管2123的管壁；进一步地，限制件1125的两端在伸出外套管2123的管壁后，通过形状约束从而形成对限制件1125在径向方向上移动的限制，例如，将限制件1125的两端设成球头状或其他形状的凸起，只要凸起在轴向方向的外径大于外套管2123的管壁上用于收容限制件1125的通孔的直径即可。在其他实施例中，近端收束件112内可不设有限制件1125。
在其它实施例中，限制件1125仅贯穿内套管2121的管壁，且限制件1125的两端分别收容并固定在内套管2121的通孔2126和通孔2127内。进一步地，在其中一个实施例中，如图16所示，限制件1125仅贯穿内套管2121的管壁，且限制件1125的两端分别从内套管2121的通孔2126和通孔2127内伸出，并通过热熔等方式形成球头状，从而将内套管2121卡接在两个球头之间，同时由于限制件1125的两端分别穿过薄膜件117，从而也将薄膜件117的靠近限制件1125的部分进行相对固定。
在其他实施例中，近端收束件112的近端设有与内套管2121连接的端盖1126，薄膜件117的收束区域118至少部分地收容或固定在端盖1126与外套管2123之间，从而进一步将薄膜件117稳固地固定在近端收束件112内。作为其中一种实现方式，如图16所示，外套管2123的长度与中间套管2122的长度一致，内套管2121的长度大于外套管2123的长度，也大于中间套管2122的长度。第一部分110上多根编织丝111的近端从端盖1126和外套管2123之间的空隙伸入到中间套管2122和外套管2123之间的空隙中，直至伸入到中间套管2122的远端端部后，通过焊接等方式固定在中间套管2122的远端端部和外套管2123的远端端部。在其他实施例中，端盖1126可进一步将薄膜件117抵压在外套管 2123和/或中间套管2122上。在其他实施例中，近端收束件112的远端也可设有与外套管2123或内套管2121连接的端盖1126，以进一步将薄膜件117稳固地固定在近端收束件112内，还可封堵近端收束件112远端的开口，提高密封性。
在其他实施例中，薄膜件117的收束区域118设有如图11所示的开孔1171，且薄膜件117的围合形成该开孔1171的部分收容并固定在近端收束件112内。具体地，如图17所示，薄膜件117的围合形成该开孔1171的部分从端盖1126和外套管2123之间的空隙伸入，并被固定到外套管2123、中间套管2122和端盖1126之间。在其他实施例中，薄膜件117的围合形成该开孔1171的部分可进一步伸入到内套管2121和中间套管2122之间或是中间套管2122和外套管2123之间，并呈环形或管状而被夹紧或卡接在相邻两个套管之间，只要不影响多根编织丝111的近端固定在近端收束件112内即可。这种薄膜件117可用在需要近端收束件112的远端开口2124不被封闭的情况下。在其他实施例中，近端收束件112内可不设有限制件1125或端盖1126，内套管2121内也可不设有螺纹1124或卡接件。
如图18所示，外套管2123的近端端部和中间套管2122的近端端部围合形成近端收束件112的外侧近端入口221，中间套管2122的近端端部和内套管2121的近端端部围合形成近端收束件112的内侧近端入口222，外套管2123的远端端部和中间套管2122的远端端部围合形成近端收束件112的外侧远端入口223，中间套管2122的远端端部和内套管2121的远端端部围合形成近端收束件112的内侧远端入口224。如图15至图17所示，第一部分110的多根编织丝111的近端收容或固定在外套管2123和中间套管2122之间。在其他实施例中，第一部分110的多根编织丝111的近端收容或固定在中间套管2122和内套管2121之间。具体地，第一部分110的多根编织丝111的近端在通过近端收束件112的外侧近端入口221、外侧远端入口223、内侧远端入口224中的其中一个后，收容或固定在近端收束件112内。
作为其中一些实施例，当第一部分110的多根编织丝111的近端是通过近端收束件112的外侧近端入口221被接收和固定时，薄膜件117的收束区域118经由近端收束件112的内侧近端入口222而至少部分地固定在内套管2121和中间套管2122之间，或是至少部分地固定在外套管2123、中间套管2122和端盖1126之间。当第一部分110的多根编织丝111的近端是通过近端收束件112的外侧远端入口223被接收和固定时，薄膜件117的收束区域118经由近端收束件112的外侧近端入口221或内侧近端入口222而至少部分地收容或固定在相邻两个套管之间，或是至少部分地固定在外套管2123、中间套管2122和端盖1126之间。当第一部分110的多根编织丝111的近端是通过近端收束件112的内侧远端入口224被接收和固定时，薄膜件117的收束区域118经由近端收束件112的外侧近端入口221、内侧近端入口222、外侧远端入口223中的任意一个而至少部分地收容或固定在内套管2121和外套管2123之间，或是至少部分地固定在外套管2123、中间套管2122和端盖1126之间。
在其他实施例中，第一部分110的内部还设有至少一层阻流膜，用于阻止 血液从第一部分110的近端盘面114流入第一部分110的内部，从而进一步提高第一部分110的封堵性能。
实施例7
实施例7的封堵装置中与实施例6相同的部分在此不再赘述，两者的区别主要在于，实施例6所描述的第一部分110的近端收束件112或远端收束件113，同样可用于第二部分120的近端收束件122或远端收束件123。
具体地，第二部分120的薄膜件124至少覆盖第二部分120的近端盘面126的部分外表面，且薄膜件124的收束区域125至少部分地固定在第二部分120的近端收束件122内。在其他实施例中，第二部分120上的薄膜件124还可进一步覆盖第二部分120的边沿127，也即第二部分120的近端盘面126和远端盘面128之间的侧面部分。进一步地，在其他实施例中，第二部分120上的薄膜件124还可以覆盖第二部分120的远端盘面128，也即薄膜件124覆盖了第二部分120的近端盘面126、边沿127和远端盘面128。在此基础上，实施例6中第一部分110上设置的近端收束件112的上述多种具体结构，以及收容和固定多根编织丝111的近端、薄膜件117的收束区域118的多种具体方式，同样适用于第二部分120上的近端收束件122，在此不再赘述。
实施例8
实施例8的封堵装置中与实施例6相同的部分在此不再赘述，两者的区别主要在于，实施例6所描述的近端收束件112可设置在第一部分110的远端而作为远端收束件113，两者的结构、与薄膜件117的配合方式、在收束件内的固定方式等特征均相同或近似。
具体地，第一部分110的薄膜件117至少覆盖第一部分110的远端盘面115的部分外表面，且薄膜件117的收束区域118至少部分地固定在第一部分110的远端收束件113内。在其他实施例中，第一部分110上的薄膜件117还可进一步覆盖第一部分110的边沿116。进一步地，第一部分110上的薄膜件117还可以覆盖第一部分110的近端盘面114，也即薄膜件117覆盖了第一部分110的远端盘面115、边沿116和近端盘面114。
如图18所示，第一部分110的远端收束件113包括均中空且由内而外依次套设的内套管2121、中间套管2122和外套管2123。外套管2123的近端端部和中间套管2122的近端端部围合形成远端收束件113的外侧近端入口221，中间套管2122的近端端部和内套管2121的近端端部围合形成远端收束件113的内侧近端入口222，外套管2123的远端端部和中间套管2122的远端端部围合形成远端收束件113的外侧远端入口223，中间套管2122的远端端部和内套管2121的远端端部围合形成远端收束件113的内侧远端入口224。第一部分110的多根编织丝111的远端在通过远端收束件113的外侧近端入口221、内侧近端入口222、外侧远端入口223中的其中一个后，收容或固定在远端收束件113内。
在其中一些实施例中，当第一部分110的多根编织丝111的远端是通过远端收束件113的外侧近端入口221被接收和固定时，薄膜件117的收束区域118经由远端收束件113的外侧远端入口223或内侧远端入口224而至少部分地收容或固定在相邻两个套管之间。当第一部分110的多根编织丝111的远端是通过 远端收束件113的内侧近端入口222被接收和固定时，薄膜件117的收束区域118经由远端收束件113的外侧近端入口221、外侧远端入口223、内侧远端入口224中的任意一个而至少部分地收容或固定在相邻两个套管之间。当第一部分110的多根编织丝111的远端是通过远端收束件113的外侧远端入口223被接收和固定时，薄膜件117的收束区域118经由远端收束件113的内侧远端入口224而至少部分地收容或固定在内套管2121和中间套管2122之间。
实施例9
实施例9的封堵装置中与实施例8相同的部分在此不再赘述，两者的区别主要在于，实施例8所描述的第一部分110的远端收束件113同样可用于第二部分120的远端收束件123。
具体地，第二部分120的薄膜件124至少覆盖第二部分120的远端盘面128的部分外表面，且薄膜件124的收束区域125至少部分地固定在第二部分120的远端收束件123内。在其他实施例中，第二部分120上的薄膜件124还可进一步覆盖第二部分120的边沿127，也即第二部分120的近端盘面126和远端盘面128之间的侧面部分。进一步地，在其他实施例中，第二部分120上的薄膜件124还可以覆盖第二部分120的近端盘面126，也即薄膜件124覆盖了第二部分120的远端盘面128、边沿127和近端盘面126。在此基础上，实施例8中第一部分110上设置的远端收束件113的上述多种具体结构，以及收容和固定多根编织丝111的远端、薄膜件117的收束区域118的多种具体方式，同样适用于第二部分120上的远端收束件123，在此不再赘述。
需要说明的是，在其他实施例中，实施例5中描述的设置在第一部分110边沿116或第二部分120的边沿127上的延伸件119的相关技术特征，同样适用于实施例6至实施例9，在此不再赘述。
实施例10
其中，现有的封堵器中，用于封堵体内开口的密封盘，一般是通过编织丝编织成网管，且网管的两端均需要通过栓头进行收口固定，栓头在收口编织丝的一端后，往往是凸出于密封盘的盘面的，因而在该盘面和栓头暴露于血流中时，容易在该栓头处形成血栓，血栓随着血流流入人体大脑后，容易堵塞血管，诱发中风，危害着人体健康。
鉴于此，本实施例针对现有的封堵装置中由于栓头凸出于密封盘的盘面而容易形成血栓的问题提供一种新的、安全性高封堵装置，使得该封堵装置可更安全的服务于患者。
实施例10的封堵装置300，如图19所示，包括第一部分310和与第一部分310连接的第二部分320。第一部分310包括多根编织丝111和相对位于近端的收束件(也即近端收束件112)，多根编织丝111的近端收容并固定在近端收束件112内，从而多根编织丝111的近端固定于近端收束件112。第一部分310还可包括相对位于远端的收束件(也即远端收束件113)，多根编织丝111的远端收容并固定在远端收束件113内，从而多根编织丝111的远端固定于远端收束件113。
第一部分310的多根编织丝111可被编织形成网管状，并在热定型后呈现 盘状或柱状等形状。第一部分310在展开状态下包括一个近端盘面114和一个远端盘面115。第一部分310的近端盘面114由第一部分310的多根编织丝111的相对位于近端的至少一部分配合形成。第一部分310的远端盘面115由第一部分310的多根编织丝111的相对位于远端的至少一部分配合形成。第一部分310的近端盘面114和远端盘面115连接的部分，形成第一部分310的边沿116。
第一部分310的近端收束件112可以为一个中空的套管，也可以为上述任一实施例所描述的由内套管1121和外套管1122构成的双套管，还可以为由内套管2121、中间套管2122和外套管2123构成的三层套管，其结构及收束编织丝111的方式等技术特征相同或类似，在此不再赘述。第一部分310的远端收束件113的结构不限，可以为前述的一个中空的套管、双套管、三层套管中的任意一种。
本实施例中，第一部分310的远端收束件113直接与第二部分320的近端连接，而无需在第一部分310和第二部分320之间设置连接件；第二部分320包括多个支撑杆321，且支撑杆321的近端均固定在第一部分310的远端收束件113上；支撑杆321上设有锚刺322，用于刺入体内组织后增强第二部分320的锚定稳固性。在其他实施例中，第一部分310的远端收束件113可设置在第二部分320的近端收束件内并固定连接，从而将第一部分310和第二部分320连接起来。第二部分320的具体结构不限，在其他实施例中也可为实施例1中所描述的第二部分120。
第一部分310的收束区域318是指沿着第一部分310的径向方向、靠近第一部分310的中轴线的部分，覆盖的区域可以为以第一部分310的中轴线为中心且半径为第一部分310半径的1/4至1/2范围内的区域。第一部分310的收束区域318包括多根编织丝111的一部分通过形状收敛形成的聚拢部。在本实施例的其中一种实现方式中，该聚拢部包括第一聚拢部311和第二聚拢部312，且聚拢部的一部分外表面组成近端盘面114的一部分。第一聚拢部311和第二聚拢部312在无外力作用时相互靠近，以将第一部分310的近端收束件112包围在第一部分310内的由第一聚拢部311和第二聚拢部312围合的空间内。从而避免了第一部分310的近端收束件112较近端盘面114更靠近近端，也即近端收束件112朝向近端凸出于近端盘面114，所存在的容易在近端收束件112处形成血栓的风险。
作为其中一种实施方式，当封堵装置300连接输送钢缆的远端，并一起收容在鞘管内，进而被植入到左心耳等体内组织的腔体内后，朝近端回撤鞘管以使封堵装置300在解除鞘管给予的径向束缚后自膨胀展开，从而得到释放。第一部分310在释放后，作为其中一种实施方式，其远端盘面115的边缘部分贴靠在左心耳的开口处的组织上，从而封堵左心耳的开口。结合图19和图20A所示，在鞘管(图未示出)回撤后，当输送钢缆400还未与封堵装置300解除连接时，输送钢缆400的远端仍与第一部分310的近端收束件112连接，连接方式可以为螺纹连接，在此不做限制。此时，第一聚拢部311和第二聚拢部312在输送钢缆400的远端部分所提供的外力作用下相互远离。具体地，第一聚拢部311和第二聚拢部312的以输送钢缆400的远端部分为中心而相对的部分， 抵接在输送钢缆400的远端部分上，其从近端朝远端看去时的截面示图请参考图20B。
结合图19和图21A所示，当输送钢缆400的远端与第一部分310的近端收束件112解除连接后，第一聚拢部311和第二聚拢部312由于失去了输送钢缆400的远端部分的外力作用而相互靠近，其从近端朝远端看去时的截面示图请参考图21B。第一聚拢部311和第二聚拢部312相互靠近后的近端盘面114是近似封闭的，从而将第一部分310的近端收束件112包围在第一部分310内的由第一聚拢部311和第二聚拢部312围合的空间内，具体地，是包围在第一部分310的近端盘面114和远端盘面115之间。此时的近端盘面114是平坦且封闭的，因而封堵装置300完全释放后，在血流的不断冲刷下，不容易在第一部分310的近端盘面114处形成血栓，提高了手术的安全性。
需要说明的是，请参考图21B，第一聚拢部311和第二聚拢部312相互靠近后可能会有小的间隙(图21B最中心的小孔处)存在，该间隙的最大外径小于或等于5毫米，优选地小于或等于3毫米。实际设计时，该间隙的尺寸一般会小于多根编织丝111形成的编织网的网孔的尺寸或者小于上述内套管的内径，因而即使第一聚拢部311和第二聚拢部312相互靠近后仍有间隙存在，也往往不会诱发血栓的形成，也可视为由第一聚拢部311和第二聚拢部312各自的一部分外表面配合形成的近端盘面114依然是封闭的。
在另一实施例中，如果第一聚拢部311和第二聚拢部312相互靠近后仍有间隙存在，则可在该间隙处设置封闭件，以使由第一聚拢部311和第二聚拢部312配合形成的近端盘面114是封闭的。其中，封闭件可以为栓塞剂等胶状物，特点是凝固后形状相对稳定且不易被液体渗透；可在输送钢缆400与第一部分310解除连接后，将栓塞剂注入到第一聚拢部311和第二聚拢部312围合的空间内，从而将该空间填充，进而保证近端盘面114是封闭的。封闭件还可以为与第一部分310连接的可压缩和可自膨胀展开的封盖，因而可以在封盖展开后覆盖该间隙，同样能够保证近端盘面114是封闭的。封闭件还可以为其他结构的组件，结构不做限制，只要能够使近端盘面114是封闭的即可，此处不再一一列举出来。此外，血流经过该间隙进入聚拢部围合的空间内后容易血栓化，且形成的血栓不容易从该间隙向外溢出，会稳定地存在于该空间内，从而将该空间填塞满，使得盘面呈封闭状。
在其他实施例中，聚拢部的具体形状、个数以及在第一部分310上的具体设置位置均不做限制，只要聚拢部能够在自然状态下或在解除外力作用后，将近端收束件112或远端收束件113包围在第一部分310的内侧，从而避免近端收束件112或远端收束件113凸出于第一部分310的外部而易于诱发形成血栓的风险。此外，由于包围近端收束件112或远端收束件113的聚拢部配合形成平坦且封闭的盘面，因而能够彻底避免第一部分310的外侧容易诱发形成血栓的风险。可以理解，第一部分310上设置的聚拢部的相关特征，也可以挪用到第二部分320上。
封堵装置300还包括设置在第一部分310上的一层或多层薄膜件117。如图19所示，薄膜件117覆盖第一部分310的近端盘面114和边沿116，因而薄膜件 117也覆盖第一聚拢部311的外表面和第二聚拢部312的外表面。薄膜件117的收束区域至少部分地收容或固定在第一部分310的近端收束件112内。需要说明的是，本实施例中与薄膜件117相关的技术特征与实施例1中薄膜件117的相关技术特征相同或近似，在此不再赘述。第一部分310上设置的薄膜件117可进一步提高其密封性，实现多层封堵。在其他实施例中，第一部分310上可不设有薄膜件117，只要第一聚拢部311和第二聚拢部312相互配合能够形成平坦的近端盘面114，即可避免在近端盘面114处形成血栓。在其他实施例中，薄膜件117覆盖第一聚拢部311的部分外表面，或覆盖第二聚拢部312的部分外表面，或覆盖第一聚拢部311和第二聚拢部312各自的部分外表面。
第一聚拢部311和第二聚拢部312的具体形状不做限制，两者只要能够在相互靠近后使形成的近端盘面114呈封闭状且表面平坦即可。在其他实施例中，如图22所示，第一聚拢部311包括一个凸起部313和一个凹陷部314，第二聚拢部312包括一个凹陷部315和一个凸起部316；第一聚拢部311和第二聚拢部312靠近后，第一聚拢部311的凸起部313抵接第二聚拢部312的凹陷部315，第一聚拢部311的凹陷部314抵接第二聚拢部312的凸起部316，从而使第一聚拢部311和第二聚拢部312能够贴合的更充分且更易于形成较为平坦的近端盘面114，避免在近端盘面114处形成血栓。在另一实施例中，第一聚拢部311包括多个凸起部313和多个凹陷部314，第二聚拢部312包括多个凹陷部315和多个凸起部316，第一聚拢部311和第二聚拢部312相互靠近后，第一聚拢部311的多个凸起部313分别抵接第二聚拢部312的一个凹陷部315，第一聚拢部311的多个凹陷部314分别抵接第二聚拢部312的一个凸起部316。由此，当第一聚拢部311抵接第二聚拢部312后，第一部分310的近端盘面114是封闭的，并将第一部分310的近端收束件112封闭在第一部分310的内部而不与血液接触，避免了血栓的形成。在这些实施例中，第一聚拢部311和第二聚拢部312在轴向方向上部分地重叠，在径向方向上也部分地重叠。为了保证形成的近端盘面114是封闭的，第一聚拢部311和第二聚拢部312相互靠近后，至少在径向方向上相互贴合。在其他实施例中，可以有第一聚拢部311的多个凸起部313抵接于第二聚拢部312的其中一个凹陷部315，也能够使第一聚拢部311和第二聚拢部312相互抵接。
进一步地，在其他实施例中，第一部分310还设有复位件，第一聚拢部311和第二聚拢部312在解除外力作用后，复位件将第一聚拢部311和第二聚拢部312相互聚拢。在其中一种实施方式中，如图23所示，复位件317包括磁性相反的磁铁3171和磁铁3172，第一聚拢部311上设置磁铁3171，第二聚拢部312上设置磁铁3172。相同磁性的磁铁的个数及具体设置位置等不做限制，例如，还可在第一部分310的近端收束件112上设置磁铁，以吸附设置在第一聚拢部311和/或第二聚拢部312上的磁铁。第一聚拢部311和第二聚拢部312在输送钢缆400对其的作用力解除后，继而在这两种磁铁的相互吸附作用下相互聚拢，以促进第一聚拢部311和第二聚拢部312相互靠近并最终形成封闭的近端盘面114。
在另一实施方式中，如图24所示，复位件318包括靠近第一聚拢部311设 置的第一复位杆3181和靠近第二聚拢部312设置的第二复位杆3182，第一聚拢部311和第二聚拢部312在第一复位杆3181和第二复位杆3182的作用下相互聚拢。具体地，第一复位杆3181的一端固定在第一部分310的近端收束件112的远端，另一端自近端收束件112的远端伸出后朝向近端盘面114延伸，并在靠近近端盘面114的位置处径向向外延伸一段距离，且不伸出第一部分310的边沿116；第二复位杆3182以近端收束件112为中心而与第一复位杆3181对称设置。在另一实施方式中，第一复位杆3181和第二复位杆3182对称设置，且第一复位杆3181的一端固定在近端收束件112的远端，另一端自近端收束件112的远端伸出后朝向第一聚拢部311弯曲延伸；第二复位杆3182的一端固定在近端收束件112的远端，另一端自近端收束件112的远端伸出后朝向第二聚拢部312弯曲延伸。在这些实施例中，当第一部分310收容在鞘管内时，第一复位杆3181和第二复位杆3182均顺应第一部分310的变形而呈近似直线状，并能够在第一部分310脱离鞘管约束后恢复上述形状，从而促进第一聚拢部311和第二聚拢部312相互靠近并最终形成封闭的近端盘面114。
在另一实施方式中，如图25所示，复位件319包括连接第一聚拢部311和第二聚拢部312的弹性线圈。弹性线圈具有较好的弹性，能够在输送钢缆400与近端收束件112连接时径向向外撑开，以不阻挡该连接，也不妨碍第一聚拢部311和第二聚拢部312的分离；还能够在输送钢缆400与近端收束件112解除连接后，使第一聚拢部311和第二聚拢部312在弹性线圈的收缩作用下相互聚拢。这样的弹性线圈可根据需求设置一个或多个。
在其他一些实施例中，可对应分别包括上述实施例1至实施例9中任一实施例中所描述的所有技术特征，也即，实施例10中所描述的关于第一部分310的上述技术特征可以视为是在上述实施例1至实施例9的任一实施例的基础上的延续，相同的部分在此不再赘述。
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 (24)

  1. 一种封堵装置，包括第一部分和与所述第一部分连接的第二部分，所述第一部分或所述第二部分包括多根编织丝和收束件，所述多个编织丝的靠近所述多根编织丝的一端的部分配合形成一个盘面，其特征在于，所述封堵装置还包括薄膜件，所述薄膜件至少覆盖所述盘面的部分外表面，所述收束件包括均中空且套设的内套管和外套管，所述多根编织丝的一端和所述薄膜件的收束区域的至少一部分均固定于所述收束件。
  2. 根据权利要求1所述的封堵装置，其特征在于，所述薄膜件的收束区域设有开孔，且所述薄膜件的围合形成所述开孔的部分收容并固定在所述收束件内。
  3. 根据权利要求1所述的封堵装置，其特征在于，所述收束件的一端设有与所述内套管连接的端盖，所述薄膜件的收束区域至少部分地收容或固定在所述端盖与所述外套管之间。
  4. 根据权利要求1所述的封堵装置，其特征在于，所述盘面的至少靠近所述收束件的部分与所述收束件的中轴线垂直。
  5. 根据权利要求1所述的封堵装置，其特征在于，所述内套管的内壁上设有螺纹或卡接件。
  6. 根据权利要求1所述的封堵装置，其特征在于，所述内套管的腔体内设有径向延伸或与所述内套管的中心轴具有夹角的限制件。
  7. 根据权利要求1所述的封堵装置，其特征在于，所述第一部分或所述第二部分还包括位于其边沿的延伸件，所述薄膜件还覆盖所述延伸件，所述延伸件在展开后径向向外撑开所述薄膜件。
  8. 根据权利要求1-7任一项所述的封堵装置，其特征在于，所述内套管的近端端部和所述外套管的近端端部围合形成所述收束件的近端入口，所述内套管的远端端部和所述外套管的远端端部围合形成所述收束件的远端入口，且所述多根编织丝的一端在通过所述收束件的所述近端入口或所述远端入口后，固定于所述内套管和所述外套管之间。
  9. 根据权利要求8所述的封堵装置，其特征在于，所述收束件设置在所述第一部分或所述第二部分的近端，所述多根编织丝的一端为近端，当所述多根编织丝的近端是通过所述收束件的所述近端入口被接收和固定时，所述薄膜件的收束区域经由所述收束件的所述近端入口而至少部分地固定在所述内套管和所述外套管之间；或者，当所述多根编织丝的近端是通过所述收束件的所述远端入口被接收和固定时，所述薄膜件的收束区域经由所述收束件的所述近端入口或所述远端入口而至少部分地收容或固定在所述内套管和所述外套管之间。
  10. 根据权利要求8所述的封堵装置，其特征在于，所述收束件设置在所述第一部分或所述第二部分的远端，所述多根编织丝的一端为远端，当所述多根编织丝的远端是通过所述收束件的所述近端入口被接收和固定时，所述薄膜件的收束区域经由所述收束件的所述近端入口或所述远端入口而至少部分地收容或固定在所述内套管和所述外套管之间；或者，当所述多根编织丝的远端是通过所述收束件的所述远端入口被接收和固定时，所述薄膜件的收束区域经由所述收束件的所述远端入口而至少部分地收容或固定在所述内套管和所述外套 管之间。
  11. 根据权利要求1-7任一项所述的封堵装置，其特征在于，所述收束件还包括中空且套设于所述内套管和所述外套管之间的中间套管。
  12. 根据权利要求11所述的封堵装置，其特征在于，所述多根编织丝的一端收容或固定于所述外套管和所述中间套管之间，或者，收容或固定于所述中间套管和所述内套管之间。
  13. 根据权利要求12所述的封堵装置，其特征在于，所述外套管的近端端部和所述中间套管的近端端部围合形成所述收束件的外侧近端入口，所述中间套管的近端端部和所述内套管的近端端部围合形成所述收束件的内侧近端入口，所述外套管的远端端部和所述中间套管的远端端部围合形成所述收束件的外侧远端入口，所述中间套管的远端端部和所述内套管的远端端部围合形成所述收束件的内侧远端入口；所述收束件设置在所述第一部分或所述第二部分的近端，所述多根编织丝的一端为近端，所述多根编织丝的一端在通过所述外侧近端入口、所述外侧远端入口、所述内侧远端入口中的其中一个后，收容或固定于所述收束件。
  14. 根据权利要求12所述的封堵装置，其特征在于，所述外套管的近端端部和所述中间套管的近端端部围合形成所述收束件的外侧近端入口，所述中间套管的近端端部和所述内套管的近端端部围合形成所述收束件的内侧近端入口，所述外套管的远端端部和所述中间套管的远端端部围合形成所述收束件的外侧远端入口，所述中间套管的远端端部和所述内套管的远端端部围合形成所述收束件的内侧远端入口；所述收束件设置在所述第一部分或所述第二部分的远端，所述多根编织丝的一端为远端，所述多根编织丝的一端在通过所述外侧近端入口、所述内侧近端入口、所述外侧远端入口中的其中一个后，收容或固定于所述收束件。
  15. 一种封堵装置，包括第一部分，所述第一部分包括多根编织丝和收束件，所述多根编织丝的一端固定于所述收束件，所述第一部分具有至少一个盘面，其特征在于，所述多根编织丝的一部分通过形状收敛形成聚拢部，所述收束件位于所述聚拢部围合的空间内，且由所述聚拢部配合形成的至少一个所述盘面是平坦且封闭的。
  16. 根据权利要求15所述的封堵装置，其特征在于，所述聚拢部包括第一聚拢部和第二聚拢部，所述第一聚拢部和所述第二聚拢部在无外力作用时相互靠近，以将所述收束件包围在所述第一聚拢部和所述第二聚拢部围合的空间内；所述第一聚拢部和所述第二聚拢部在外力作用下可相互远离。
  17. 根据权利要求16所述的封堵装置，其特征在于，所述第一聚拢部和所述第二聚拢部相互靠近后形成的间隙的最大外径小于或等于5毫米；或者，所述第一聚拢部和所述第二聚拢部相互靠近且至少在径向方向上相互贴合。
  18. 根据权利要求17所述的封堵装置，其特征在于，所述第一聚拢部和所述第二聚拢部形成的间隙处设有封闭件，以使由所述聚拢部配合形成的至少一个所述盘面是封闭的。
  19. 根据权利要求16所述的封堵装置，其特征在于，所述第一聚拢部包括 至少一个凸起部，所述第二聚拢部包括至少一个凹陷部，所述第一聚拢部和所述第二聚拢部相互靠近后，至少一个所述凸起部抵接于一个所述凹陷部。
  20. 根据权利要求16所述的封堵装置，其特征在于，所述第一部分还设有复位件，所述第一聚拢部和所述第二聚拢部在外力作用解除后，所述复位件将所述第一聚拢部和所述第二聚拢部相互聚拢。
  21. 根据权利要求20所述的封堵装置，其特征在于，所述复位件包括磁性相反的至少两个磁铁，所述第一聚拢部和所述第二聚拢部在所述至少两个磁铁的作用下相互聚拢。
  22. 根据权利要求20所述的封堵装置，其特征在于，所述复位件包括靠近所述第一聚拢部设置的第一复位杆和靠近所述第二聚拢部设置的第二复位杆，所述第一聚拢部和所述第二聚拢部在所述第一复位杆和所述第二复位杆的作用下相互聚拢。
  23. 根据权利要求20所述的封堵装置，其特征在于，所述复位件包括连接所述第一聚拢部和所述第二聚拢部的至少一个弹性线圈，所述第一聚拢部和所述第二聚拢部在所述弹性线圈的作用下相互聚拢。
  24. 根据权利要求15所述的封堵装置，其特征在于，所述封堵装置还包括薄膜件，所述薄膜件至少覆盖所述聚拢部的部分外表面。
PCT/CN2021/112111 2020-08-12 2021-08-11 封堵装置 WO2022033530A1 (zh)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP21855581.1A EP4197455A1 (en) 2020-08-12 2021-08-11 Plugging device
CA3186828A CA3186828A1 (en) 2020-08-12 2021-08-11 Plugging device
US18/040,180 US20230320713A1 (en) 2020-08-12 2021-08-11 Plugging device

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
CN202010808213.2A CN114073560B (zh) 2020-08-12 2020-08-12 封堵装置
CN202021692698.5 2020-08-12
CN202021692923.5U CN213552081U (zh) 2020-08-12 2020-08-12 封堵装置
CN202021692698.5U CN213552080U (zh) 2020-08-12 2020-08-12 封堵装置
CN202010808213.2 2020-08-12
CN202021692923.5 2020-08-12

Publications (1)

Publication Number Publication Date
WO2022033530A1 true WO2022033530A1 (zh) 2022-02-17

Family

ID=80246985

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2021/112111 WO2022033530A1 (zh) 2020-08-12 2021-08-11 封堵装置

Country Status (4)

Country Link
US (1) US20230320713A1 (zh)
EP (1) EP4197455A1 (zh)
CA (1) CA3186828A1 (zh)
WO (1) WO2022033530A1 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024020141A1 (en) * 2022-07-21 2024-01-25 Boston Scientific Scimed, Inc. Implantable medical device with primary covering and secondary covering

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101120893A (zh) * 2006-08-08 2008-02-13 深圳市先健科技股份有限公司 心脏间隔缺损封堵器
US20150313603A1 (en) * 2014-05-01 2015-11-05 Cook Medical Technologies Llc Implantable medical device with twisted element
CN106456422A (zh) * 2014-04-14 2017-02-22 后续医疗股份有限公司 用于治疗血管缺损的装置
CN206214129U (zh) * 2016-07-19 2017-06-06 上海形状记忆合金材料有限公司 一种外包膜封堵器
CN209437312U (zh) * 2017-05-08 2019-09-27 杨锋云 分体式左心耳封堵器
CN111317516A (zh) * 2018-12-14 2020-06-23 杭州唯强医疗科技有限公司 一种可监测腔内压力的封堵装置
CN213552080U (zh) * 2020-08-12 2021-06-29 先健科技(深圳)有限公司 封堵装置
CN213552081U (zh) * 2020-08-12 2021-06-29 先健科技(深圳)有限公司 封堵装置

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101120893A (zh) * 2006-08-08 2008-02-13 深圳市先健科技股份有限公司 心脏间隔缺损封堵器
CN106456422A (zh) * 2014-04-14 2017-02-22 后续医疗股份有限公司 用于治疗血管缺损的装置
US20150313603A1 (en) * 2014-05-01 2015-11-05 Cook Medical Technologies Llc Implantable medical device with twisted element
CN206214129U (zh) * 2016-07-19 2017-06-06 上海形状记忆合金材料有限公司 一种外包膜封堵器
CN209437312U (zh) * 2017-05-08 2019-09-27 杨锋云 分体式左心耳封堵器
CN111317516A (zh) * 2018-12-14 2020-06-23 杭州唯强医疗科技有限公司 一种可监测腔内压力的封堵装置
CN213552080U (zh) * 2020-08-12 2021-06-29 先健科技(深圳)有限公司 封堵装置
CN213552081U (zh) * 2020-08-12 2021-06-29 先健科技(深圳)有限公司 封堵装置

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024020141A1 (en) * 2022-07-21 2024-01-25 Boston Scientific Scimed, Inc. Implantable medical device with primary covering and secondary covering

Also Published As

Publication number Publication date
US20230320713A1 (en) 2023-10-12
CA3186828A1 (en) 2022-02-17
EP4197455A1 (en) 2023-06-21

Similar Documents

Publication Publication Date Title
JP6154394B2 (ja) 患者の脈管構造における異常な開口部を閉塞する機器および方法
US8834519B2 (en) Method and device for left atrial appendage occlusion
CN109688940A (zh) 血管封堵器
KR101789801B1 (ko) 가변 협각의 편평 디스크 면을 구비한 폐쇄기
BR112013029223B1 (pt) oclusor para ocluir uma passagem em um sistema circulatório
CN209474706U (zh) 分体式左心耳封堵器
WO2020259710A1 (zh) 封堵装置
WO2022033530A1 (zh) 封堵装置
CN114587472B (zh) 一种封堵器
WO2022121630A1 (zh) 封堵装置
CN213552080U (zh) 封堵装置
CN114073560B (zh) 封堵装置
CN115517735B (zh) 封堵装置
CN113116407B (zh) 封堵装置
CN213552081U (zh) 封堵装置
CN113116405B (zh) 封堵装置
CN113116406B (zh) 封堵装置
CN211560184U (zh) 腔内封堵器
WO2024046392A1 (zh) 封堵装置
CN219803754U (zh) 封堵装置
WO2022121631A1 (zh) 封堵装置
CN113974716B (zh) 封堵装置
CN219229973U (zh) 一种卵圆孔未闭封堵器
WO2022257992A1 (zh) 左心耳封堵消融装置
CN115778467B (zh) 一种动脉瘤栓塞装置及系统

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21855581

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 3186828

Country of ref document: CA

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2021855581

Country of ref document: EP

Effective date: 20230313