WO2021073453A1 - 封堵装置 - Google Patents

封堵装置 Download PDF

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Publication number
WO2021073453A1
WO2021073453A1 PCT/CN2020/120077 CN2020120077W WO2021073453A1 WO 2021073453 A1 WO2021073453 A1 WO 2021073453A1 CN 2020120077 W CN2020120077 W CN 2020120077W WO 2021073453 A1 WO2021073453 A1 WO 2021073453A1
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WO
WIPO (PCT)
Prior art keywords
edge
sealing
disk
plugging device
disc
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2020/120077
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English (en)
French (fr)
Inventor
李安宁
刘建勇
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lifetech Scientific Shenzhen Co Ltd
Original Assignee
Lifetech Scientific Shenzhen Co Ltd
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
Application filed by Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Priority to CA3157838A priority Critical patent/CA3157838A1/en
Priority to EP20876688.1A priority patent/EP4046578A4/en
Priority to US17/767,586 priority patent/US20230210537A1/en
Publication of WO2021073453A1 publication Critical patent/WO2021073453A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/1214—Coils or wires
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/1214—Coils or wires
    • A61B17/12145—Coils or wires 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
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00685—Archimedes screw

Definitions

  • the invention relates to the technical field of interventional medical devices, and in particular to a blocking device for blocking an opening in the body.
  • split left atrial appendage occluder in interventional therapy or prevention of stroke has become more and more popular, and good fixation and sealing are a major advantage of split left atrial appendage occluder.
  • the internal structure of the left atrial appendage cavity is not only diversified and complicated.
  • the sealing disc is too small or the release position of the blocking device is too deep, part or all of the edges of the sealing disc will directly abut against the left atrial appendage opening.
  • the edge of the sealing disc has a certain degree of hardness, and the heart will repeatedly contract and relax, it is easy to cause the edge of the sealing disc to wear the internal tissue at the left atrial appendage opening, which is disadvantageous to the patient.
  • a plugging device includes a sealing disk, the sealing disk includes a proximal disk surface and a distal disk surface, and an edge connecting the proximal disk surface and the distal disk surface, and at least one buffer is provided on the sealing disk
  • the at least one buffer member is distributed along the edge, and the buffer member includes at least one of the following: a film body, a suture thread, a metal coil, a sac-shaped member, and a brush.
  • the plugging device further includes a fixed disk located on one side of the sealing disk, one end of the fixed disk is connected to the sealing disk, and the other end is radially radiated toward the distal end and then toward Proximal extension.
  • the at least one buffer member surrounds the edge at least one circle; or, when there are more than one buffer member, the plurality of buffer members are distributed on the edge at intervals.
  • the buffer member is the film body, and the film body is attached to the edge for fixing.
  • the cushioning member is the film body, and two edges of the film body along the length direction are respectively fixed on the sealing disc, and between the film body and the edge A cavity is formed between.
  • At least a part of the proximal disc surface and/or at least a part of the distal disc surface is covered with a film body.
  • the edge is a rounded convex edge facing the outside between the proximal disk surface and the distal disk surface.
  • At least one end of the metal coil is fixed on the sealing disk, and there is a gap between at least a part of the metal coil and the edge.
  • one end of the brush is fixed to the proximal end or the distal end of the sealing disc, and the other end is a free end.
  • At least one baffle film is provided on the sealing disc, one end of the brush is fixed on the baffle film, and the other end is a free end.
  • At least one buffer is provided on the sealing disc, and the buffers are distributed along the edge, which avoids that the edge of the sealing disc directly abuts on the tissue at the opening in the body, and because the buffer has better buffering Therefore, when the sealing disk interacts with the internal tissues, it can reduce the damage to the internal tissues caused by the edge, better protect the internal tissues, and reduce the risk of surgery.
  • Fig. 1 is a schematic cross-sectional structure diagram of the plugging device of embodiment 1;
  • Fig. 2 is a schematic diagram of the front structure of the sealing disc in Fig. 1;
  • Fig. 3 is another structural diagram of the plugging device of embodiment 1;
  • FIG. 4 is another cross-sectional structural diagram of the sealing disc of the plugging device of Embodiment 1;
  • FIG. 5 is another schematic cross-sectional structure diagram of the sealing disc of the plugging device of Embodiment 1;
  • FIG. 6 is a schematic structural diagram of another sealing disc of the plugging device of Embodiment 1;
  • FIG. 7 is a schematic diagram of another cross-sectional structure of the plugging device of Embodiment 1;
  • FIG. 8 is another schematic cross-sectional structure diagram of the sealing disc of the plugging device of Embodiment 1;
  • FIG. 9 is a schematic diagram of another cross-sectional structure of the plugging device of Embodiment 1;
  • Figure 10 is another cross-sectional structural diagram of the plugging device of embodiment 1;
  • FIG. 11 is a schematic diagram of the structure of the sealing disc of the plugging device of Embodiment 2;
  • FIG. 13 is another structural diagram of the sealing disc of the plugging device of Embodiment 3.
  • FIG. 14 is a schematic diagram of the side structure of the sealing disc of the plugging device of Embodiment 5;
  • FIG. 15 is a schematic view of the structure of the sealing disc of the plugging device of Embodiment 5 in a compressed state
  • FIG. 16 is a partial schematic diagram of another structure of the sealing disc of the plugging device of Embodiment 5;
  • FIG. 17 is another structural diagram of the sealing disc of the plugging device of Embodiment 5.
  • FIG. 17 is another structural diagram of the sealing disc of the plugging device of Embodiment 5.
  • proximal end the end of the medical device implanted in the human 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 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 or animal body that is closer to the operator
  • distal end the end farther from the operator
  • Embodiment 1 provides a blocking device 100, which can be used to block tissues with openings in the human or animal body, such as the left atrial appendage or the foramen ovale.
  • the blocking device 100 includes a sealing disk 110 and a fixed disk 120 located on one side of the sealing disk 110. One end of the fixed disk 120 is directly connected to the sealing disk 110, and the other end is radially radiated toward the distal end and then extends toward the proximal end.
  • the sealing disk 110 includes a proximal disk surface 111 and a distal disk surface 112, and an edge 113 connecting the proximal disk surface 111 and the distal disk surface 112. At least one buffer member 114 is provided on the sealing disk 110, and these buffer members 114 are distributed along the edge 113.
  • the fixed disk 120 includes a connecting portion 121 and a plurality of supporting bodies 122, the connecting portion 121 is connected to the distal end of the sealing disk 110, one end of each of the plurality of supporting bodies 122 is connected to the connecting portion 121, and the other end is connected from The portion 121 radiates radially toward the distal end and then extends toward the proximal end.
  • the plurality of support bodies 122 cooperate to form a recessed area at the distal end of the fixed disk 120, and the free ends of the plurality of support bodies 122 cooperate at the proximal end of the fixed disk 120 to form a proximal opening.
  • the fixed disk 120 shown in FIG. 1 is laser-cut from a hollow metal tube and heat-set into an umbrella shape.
  • the uncut end of the metal tube is used as the connecting portion 121, and the cut metal rods are multiple support bodies. 122.
  • the fixed disk 120 may be woven by at least one metal wire to form a mesh tube, and then one end of the fixed disk 120 may be fixed by a sleeve necking braided wire, and heat-set into an umbrella shape. 120 also includes a recessed area at its distal end and a proximal opening at its proximal end.
  • the sleeve is the connecting portion 121 of the fixed disk 120, which is located between the connecting portion 121 of the fixed disk 120 and the proximal opening.
  • the plurality of metal wire segments in between are defined as a plurality of support bodies 122.
  • the sealing disc 110 is woven into a net shape by at least one metal wire, and then its two ends are respectively fixed by the sleeve necking braided wire, and heat-set into a flat disc shape.
  • the distal sleeve of the sealing disc 110 is connected to the connecting portion 121, and the proximal sleeve of the sealing disc 110 is also used to detachably connect with the transporter of the transporting and blocking device 100.
  • the connecting portion 121 of the fixed disk 120 and the distal end of the sealing disk 110 are indirectly connected through at least one connecting member.
  • the connecting member may be a steel sleeve or a flexible metal wire.
  • the shape of the sealing disc 110 may also be a plug shape as shown in FIG. 3, a truncated cone shape as shown in FIG. 4, an hourglass shape as shown in FIG. 5, and the like.
  • the hourglass-shaped sealing disc 110 has a proximal disc surface 111 and a distal disc surface 112, and a concave curved surface facing the central axis of the sealing disc 110 between the proximal disc surface 111 and the distal disc surface 112.
  • the curved surface is the hourglass seal.
  • the edge 113 of the disc 110 and the hourglass-shaped sealing disc 110 have a better sealing and fixing effect.
  • the sealing disc 110 having both sealing and fixing functions can also be used as the blocking device 100 alone.
  • the buffer 114 at least includes a long thin film body that surrounds the edge 113 at least once.
  • the film body can be made of PET (Polyethylene terephthalate, polyethylene terephthalate), PTFE (Polytetrafluoroethylene, polytetrafluoroethylene) and other polymer materials, so it has good flexibility and is wrapped around the edge 113
  • the nearby buffer member 114 can reduce the abrasion of the edge 113 on the tissues in the body during atrial fibrillation, play a buffering role, and can also improve the sealing performance of the sealing disk 110.
  • the two edges along the length of the film body are respectively fixed on the sealing disk 110, and a cavity is formed between the film body and the edge 113, which has a better cushioning effect.
  • the film body can be fixed to the sealing plate 110 by sewing, heat treatment bonding, or gluing.
  • the buffer member 114 includes a plurality of film bodies, the plurality of film bodies surround the edge 113 at least one circle, and the plurality of film bodies can overlap the edge 113 so as to increase the flexibility of the edge 113 in contact with tissues in the body. At the same time, it has a better buffering effect and reduces the damage to the tissues in the body.
  • the buffer 114 includes at least one elongated film body, and the film body surrounds the edge 113 at least once.
  • the two edges along the length of the film body are respectively fixed on the sealing disk 110, and the film body is attached to the edge 113 for fixing, that is, there is no obvious cavity between the film body and the edge 113.
  • each buffer member 114 includes a small film body, and each film body is sewn or glued on the edge 113, and All the buffer members 114 are distributed on the edge 113 at equal or non-equal intervals. Compared with the buffer member 114 that surrounds the edge 113 in a circle, this buffer member 114 generates less resistance when the sealing disc 110 is sheathed, which is advantageous for sheathing.
  • a portion of the proximal disk surface 111 and/or at least a portion of the distal disk surface 112 of the sealing disk 110 is covered with a film body 115.
  • the film body 115 can be integrally formed with the film body 114 provided on the edge 113, or can be independent film bodies, and the independent film bodies can be connected together by stitching or pasting, or they may not be connected together.
  • Such a sealing disk 110 can not only reduce the damage caused by the friction of the rim 113 to the tissues in the body, but also improve the sealing effect of the sealing disk 110 and realize multiple sealing.
  • the edge 113 is a smooth convex edge that is located between the proximal disk surface 111 and the distal disk surface 112 and faces outward.
  • the smooth convex edge can also reduce the friction of the edge 113 on the tissue in the body, so as to cooperate with the buffer 114 to further reduce the risk of tissue damage in the body.
  • the occlusion device 100 in the above embodiment When the occlusion device 100 in the above embodiment is transported from the body to the body, it is constrained to be approximately linear by the cavity of the delivery device such as a sheath; taking the sheath as an example, when released in the body, the sheath is returned to the proximal end Withdrawal, the fixed disk 120 located at the distal end first protrudes from the cavity of the sheath, and the distal end of each support body 122 on the fixed disk 120 first expands radially outward, and then bends toward the proximal end. The proximal part of the disc 120 is released from the sheath and continues to extend toward the proximal end until it returns to the heat-set shape.
  • the cavity of the delivery device such as a sheath
  • the released fixing plate 120 can be fixed on the inner wall of the internal body tissue with a cavity such as the left atrial appendage, so as to fix the blocking device 100 on the internal body tissue.
  • the sheath tube is further withdrawn toward the proximal end, and the sealing disc 110 extending from the cavity of the sheath tube is expanded to the shape after heat setting, so as to cover the opening of the part to be sealed and realize the sealing smoothly.
  • the plugging device of Embodiment 2 has the same parts as the plugging device 100 of Embodiment 1, which will not be repeated here.
  • the main difference between the two is that the buffer 214 on the sealing disc 210 in Embodiment 2 is at least one Suture.
  • the buffer member 214 is a plurality of sutures, the sutures are respectively wound on different parts of the edge 213, and all the sutures are distributed on the edge 213 at equal or non-equal intervals.
  • at least one suture is wound around the edge 213 and is wound around the edge 213 at least once.
  • Such a buffer member 214 can also reduce the abrasion caused by the edge 213 on the internal tissues, and play a certain buffering effect.
  • the cushioning member may include the film body 114 in Embodiment 1 and the suture 214 in Embodiment 2.
  • at least one film body may be provided on the edge 213 of the sealing disc 210, and The quantity and manner are the same as those in Example 1, and then a suture needle is used to pass through the film body and the mesh near the edge 213 in a sewing manner, and the suture thread is wound on the film body and the edge 213.
  • a buffer has better flexibility and will cause less abrasion to body tissues.
  • the plugging device of embodiment 3 and the plugging device 100 of embodiment 1 have the same parts, which will not be repeated here.
  • the main difference between the two is that the buffers on the sealing disc in embodiment 3 are multiple elastic Metal coil. 12, a plurality of metal coils 314 are provided on the edge 313, and both ends of each metal coil 314 are connected to the sealing disc 310, preferably connected to the edge 313, and between each metal coil 314 and the edge 313 There are gaps.
  • the metal coil 314 can be braided when the sealing disk 310 is made by braiding metal wires, or it can be separately manufactured and fixed to the vicinity of the edge 313 of the sealing disk 310. Such a buffer 314 can also reduce the abrasion caused by the edge 313 on the internal tissues, and play a certain buffering effect.
  • the metal coil 314 is an Archimedes spiral, and one end is fixed on the sealing disc 310, preferably on the edge 313. There are multiple gaps between the metal coil 314 and the edge 313. Therefore, it has a better cushioning effect, and the wear on the body tissues will be smaller.
  • the edge of the sealing disc 310 of the third embodiment may be covered with some film 114 as in the first embodiment, that is, part or all of the sealing disc 310 of the third embodiment
  • the metal coil 314 is covered with at least one layer of film body 114, and the added film body 114 is preferably arranged to fit the periphery of the metal coil 314. Therefore, the buffer includes at least the elastic metal coil 314 and the film body 114, and the specific combination is not limited.
  • the occlusion device of Embodiment 4 has the same parts as the occlusion device 100 of Embodiment 1, which will not be repeated here.
  • the main difference between the two is that the cushioning member in Embodiment 4 includes at least one bag-shaped member.
  • the bladder can be a closed balloon with a cavity, and the balloon can be filled by injecting liquid, or further can be contracted after the liquid is slowly released in the body.
  • the cushioning member is an elongated balloon, the balloon wraps on at least a part of the rim along its length. Preferably, the length of the balloon is just enough to cover the entire rim.
  • each balloon is respectively arranged at a different part of the edge, and all the balloons can be fixed on the sealing plate at equal or non-equal intervals.
  • Such a buffer can also reduce the abrasion caused by the edge to the tissues in the body and play a certain buffering effect.
  • the bladder can be made of silicone rubber, Pebax (polyether block polyamide), nylon PA11, a mixture of Pebax and nylon PA11, nylon 12, PET and other materials.
  • the filler is injected into the bladder through a catheter, etc., so that the balloon is filled and has a good cushioning effect .
  • the filling is preferably a liquid, such as physiological saline or other liquids with good biocompatibility.
  • a filler containing anticoagulant or antiplatelet material can be injected into the capsule, and the filler can be slowly released from the capsule into the body, so that the patient does not need to or less take anticoagulant drugs after the operation.
  • the plugging device of Embodiment 5 has the same parts as that of the plugging device 100 of Embodiment 1, which will not be repeated here.
  • the buffer in Embodiment 5 includes a plurality of brushes.
  • the brush 514 is in the shape of a thin strip.
  • One end of the brush 514 is fixed to the distal end of the sealing disk 510 (for example, fixed by a distal sleeve), the other end is a free end, and the part between the two ends is accommodated in The inside of the disk 510 is sealed.
  • the free end of the brush 514 can be partially or completely contained in the inside of the sealing disk 510; as shown in FIG.
  • the free end of the brush 514 is removed from the sealing disk 510.
  • the inside passes through the rim 513 and extends to the outside.
  • one end of the brush 514 may be disposed at the proximal end of the sealing disk 510, and the other end is a free end.
  • Such a buffer member 514 can also reduce the abrasion caused by the edge 513 on the internal tissues, and play a certain buffering effect.
  • the brush 514 may be composed of metal wire or polymer wire, and the wire diameter is between 0.01 mm and 0.04 mm.
  • the free end of the brush 514 can be further divided into bifurcated portions 515 as shown in FIG. 16, and the bifurcated portions 515 are respectively bent toward the sealing disc 510, which not only makes the part of the edge 513 in contact with the internal tissues softer, but also It is not easy for the brush 514 to directly enter the inside of the sealing disk 510 and fail to come out, which has a position limiting effect.
  • the sealing disk 510 is provided with at least one baffle film 516, one end of the brush 514 is fixed on the baffle film 516, and the other end is a free end.
  • more strips can be cut out at the edge of the baffle film 516 as the brush 514.
  • the baffle film part as the bristle brush 514 is located on the sealing plate. Outside of the 510, such a baffle film 516 not only has a sealing effect, but also can reduce the damage caused by the friction of the edge 513 to the tissue in the body.

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Abstract

一种封堵装置（100），包括密封盘（110），密封盘（110）包括近端盘面（111）和远端盘面（112），以及连接近端盘面（111）和远端盘面（112）的边沿（113），密封盘（110）上设有至少一个缓冲件（114），至少一个缓冲件（114）沿着边沿（113）分布。封堵装置（100）能够减小密封盘（110）的边沿（113）对体内组织造成的损伤，更好地保护体内组织，降低手术风险。

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
近年来，分体式左心耳封堵器在介入治疗或预防中风上的应用越来越普及，良好的固定性和密封性是分体式左心耳封堵器的一大优势。然而，左心耳腔体内部结构不仅多样化且复杂，在密封盘选型过小，或是封堵装置的释放位置过于深入时，密封盘的一部分或全部边沿会直接抵接在左心耳开口处的体内组织上。由于密封盘的边沿具有一定的硬度，且心脏会反复地进行收缩和舒张，因而，容易导致密封盘的边沿磨损左心耳开口处的体内组织，这对病人较为不利。
发明内容
基于此，有必要针对密封盘的边沿存在磨损体内开口处组织的风险的技术问题提供一种新的封堵装置。
一种封堵装置，包括密封盘，所述密封盘包括近端盘面和远端盘面，以及连接所述近端盘面和所述远端盘面的边沿，所述密封盘上设有至少一个缓冲件，所述至少一个缓冲件沿着所述边沿分布，所述缓冲件至少包括以下之一：薄膜体、缝合线、金属线圈、囊状件、毛刷。
在其中一个实施例中，所述封堵装置还包括位于所述密封盘一侧的固定盘，所述固定盘的一端与所述密封盘连接，另一端朝向远端径向辐射出后再朝向近端延伸。
在其中一个实施例中，所述至少一个缓冲件围绕所述边沿至少一圈；或者，当所述缓冲件有多个时，多个所述缓冲件在所述边沿上间隔分布。
在其中一个实施例中，所述缓冲件为所述薄膜体，所述薄膜体贴合所述边沿进行固定。
在其中一个实施例中，所述缓冲件为所述薄膜体，所述薄膜体的沿其长度方向的两个边缘分别固定在所述密封盘上，且在所述薄膜体与所述边沿之间形成一个空腔。
在其中一个实施例中，所述近端盘面的至少一部分和/或所述远端盘面的至少一部分包覆有薄膜体。
在其中一个实施例中，所述边沿为位于所述近端盘面与所述远端盘面之间的朝向外部的圆滑凸沿。
在其中一个实施例中，所述金属线圈的至少一端固定于所述密封盘上，且所述金属线圈的至少一部分与所述边沿之间存在间隙。
在其中一个实施例中，所述毛刷的一端固定于所述密封盘的近端或远端，另一端为自由端。
在其中一个实施例中，所述密封盘上设有至少一个阻流膜，所述毛刷的一端固定于所述阻流膜上，另一端为自由端。
上述封堵装置，密封盘上设有至少一个缓冲件，且缓冲件均沿着边沿分布，避免了密封盘的边沿直接抵接在体内开口处的组织上，且由于缓冲件具有较好的缓冲作用，因而在密封盘与体内组织的相互作用时，能够减小边沿对体内组织造成的损伤，更好地保护体内组织，降低手术风险。
附图说明
图1为实施例1的封堵装置的剖面结构示意图；
图2为图1中密封盘的正面结构示意图；
图3为实施例1的封堵装置的另一结构示意图；
图4为实施例1的封堵装置的密封盘的另一剖面结构示意图；
图5为实施例1的封堵装置的密封盘的另一剖面结构示意图；
图6为实施例1的封堵装置的另一密封盘的结构示意图；
图7为实施例1的封堵装置的另一剖面结构示意图；
图8为实施例1的封堵装置的密封盘的另一剖面结构示意图；
图9为实施例1的封堵装置的另一剖面结构示意图；
图10为实施例1的封堵装置的另一剖面结构示意图；
图11为实施例2的封堵装置的密封盘的结构示意图；
图12为实施例3的封堵装置的密封盘的结构示意图；
图13为实施例3的封堵装置的密封盘的另一结构示意图；
图14为实施例5的封堵装置的密封盘的侧面结构示意图；
图15为实施例5的封堵装置的密封盘在压缩状态下的结构示意图；
图16为实施例5的封堵装置的密封盘的另一结构的局部示意图；
图17为实施例5的封堵装置的密封盘的另一结构示意图。
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”。
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。
实施例1
请参考图1和图2，实施例1提供一种封堵装置100，可用于封堵人体或动物体内具有开口的组织，例如左心耳或卵圆孔等。封堵装置100包括密封盘110和位于密封盘110一侧的固定盘120。固定盘120的一端与密封盘110直接连接，另一端朝向远端径向辐射出后再朝向近端延伸。密封盘110包括近端盘面111和远端盘面112，以及连接近端盘面111和远端盘面112的边沿113。密封盘110 上设有至少一个缓冲件114，这些缓冲件114均沿着边沿113分布。
具体地，固定盘120包括连接部121和多个支撑体122，连接部121与密封盘110的远端连接，多个支撑体122各自的一端均连接在连接部121上，另一端均从连接部121朝向远端径向辐射出后再朝向近端延伸。多个支撑体122在固定盘120的远端配合形成一个凹陷区，且多个支撑体122的自由端在固定盘120的近端配合形成一个近端开口。图1所示的固定盘120由中空的金属管经激光切割后热定型成伞状，其中，金属管的未切割的一端作为连接部121，切割出的多个金属杆即为多个支撑体122。在其他实施例中，如图3所示，固定盘120可由至少一根金属丝经编织成网管状，然后将其一端通过套管收口编织丝进行固定，并热定型成伞状，该固定盘120也包括位于其远端的一个凹陷区，以及位于其近端的一个近端开口，其中，套管即为固定盘120的连接部121，位于固定盘120的连接部121和近端开口之间的多个金属丝片段定义为多个支撑体122。
密封盘110由至少一根金属丝经编织成网管状，然后将其两端分别通过套管收口编织丝进行固定，并热定型成扁平的盘状。密封盘110的远端套管与连接部121连接，密封盘110的近端套管还用于与输送封堵装置100的输送器可拆卸连接。
在其他实施例中，固定盘120的连接部121与密封盘110的远端通过至少一个连接件间接连接，例如，连接件可以是钢套或具有柔性的金属丝等。在其他实施例中，密封盘110的形状还可以为如图3所示的塞子状、如图4所示的截锥体状、如图5所示的沙漏状等。沙漏状的密封盘110具有近端盘面111和远端盘面112，以及位于近端盘面111和远端盘面112之间的朝向密封盘110的中心轴线内凹的曲面，该曲面即为沙漏状密封盘110的边沿113，沙漏状的密封盘110具有更好的密封和固定效果。在其他实施例中，同时具有密封和固定作用的密封盘110也可单独作为封堵装置100使用。
本实施例中，缓冲件114至少包括一个长条形的薄膜体，该薄膜体围绕边沿113至少一圈。薄膜体可采用PET(Polyethylene terephthalate、聚对苯二甲酸类塑料)、PTFE(Poly tetra fluoro ethylene、聚四氟乙烯)等高分子材料制成， 因而具有很好的柔软性，包覆在边沿113附近的缓冲件114能够减小房颤时边沿113对体内组织的磨损，起到缓冲作用，同时还能提高密封盘110的密封性能。此外，薄膜体的沿其长度方向的两个边缘分别固定在密封盘110上，且在薄膜体与边沿113之间形成一个空腔，缓冲效果更好。薄膜体可通过缝合或热处理粘结，或胶粘等方式固定到密封盘110上。
在其他实施例中，缓冲件114包括多个薄膜体，多个薄膜体围绕边沿113至少一圈，多个薄膜体可重叠地围绕边沿113，从而能够增大边沿113接触体内组织的柔软性，同时具有更好的缓冲作用，减少对体内组织的损伤。
在其他实施例中，缓冲件114至少包括一个长条形的薄膜体，该薄膜体围绕边沿113至少一圈。薄膜体的沿其长度方向的两个边缘分别固定在密封盘110上，薄膜体贴合边沿113进行固定，也即在薄膜体与边沿113之间没有明显的空腔。
在其他实施例中，请参考图6，密封盘110上设有多个缓冲件114，每个缓冲件114包括一个小的薄膜体，每个薄膜体被缝合或黏贴在边沿113上，且所有的缓冲件114在边沿113上等间隔或非等间隔地分布。这种缓冲件114相比于围绕边沿113一圈的缓冲件114，在密封盘110进鞘时产生的阻力更小，因而有利于进鞘。
进一步地，请参考图7，密封盘110的近端盘面111的至少一部分和/或远端盘面112的至少一部分包覆有薄膜体115。薄膜体115可与设置在边沿113上的薄膜体114一体成型，也可为相互独立的薄膜体，且相互独立的薄膜体之间可通过缝合或黏贴连接在一起，也可以不连接在一起。这样的密封盘110不仅能够减小边沿113对体内组织的摩擦造成的损伤，还能提高密封盘110的密封效果，实现多重封堵。
进一步地，请参考图8-图10，边沿113为位于近端盘面111与远端盘面112之间的朝向外部的圆滑凸沿。圆滑的凸沿也能够减小边沿113对体内组织的摩擦，从而与缓冲件114配合进一步降低体内组织损伤的风险。
上述实施例中的封堵装置100在从体外输送至体内时，被鞘管等输送装置的腔体约束为近似直线状；以鞘管为例，在体内释放时，将鞘管朝向近端回撤， 则位于远端的固定盘120首先从鞘管的腔体内伸出，且固定盘120上各个支撑体122的远端先径向向外张开，然后朝向近端弯曲，且随着固定盘120的近端部分从鞘管内释放，继续朝向近端延伸，直至恢复至热定型后的形态。释放后的固定盘120可固定在左心耳等具有腔体的体内组织的内壁上，以将封堵装置100固定在体内组织上。此后，进一步朝近端回撤鞘管，从鞘管的腔体内伸出的密封盘110展开至热定型后的形状，从而覆盖待封堵部位的开口，顺利实现封堵。
实施例2
实施例2的封堵装置与实施例1的封堵装置100中相同的部分，在此不再赘述，两者的主要区别在于，实施例2中密封盘210上的缓冲件214为至少一根缝合线。请参考图11，缓冲件214为多根缝合线，缝合线分别缠绕在边沿213的不同部位，所有的缝合线在边沿213上等间隔或非等间隔分布。在其他实施例中，至少一根缝合线缠绕在边沿213上，并且围绕边沿213至少缠绕一圈。这样的缓冲件214同样能够减小边沿213对体内组织造成的磨损，起到一定的缓冲作用。
进一步地，在其他实施例中，缓冲件可包括实施例1中的薄膜体114及实施例2中的缝合线214，例如，可在密封盘210的边沿213上设置至少一个薄膜体，设置的数量和方式均与实施例1中相同，然后使用缝合针穿过该薄膜体和边沿213附近网孔的缝合方式，将缝合线缠绕在薄膜体和边沿213上。这样的缓冲件具有更好的柔软性，对体内组织造成的磨损会更小。
实施例3
实施例3的封堵装置与实施例1的封堵装置100中相同的部分，在此不再赘述，两者的主要区别在于，实施例3中密封盘上的缓冲件为多个具有弹性的金属线圈。请参考图12，边沿313上设有多个金属线圈314，每个金属线圈314的两端均连接在密封盘310上，优选连接在边沿313上，且每个金属线圈314与边沿313之间均存在间隙。该金属线圈314可在通过编织金属丝制作密封盘310时编织制成，也可单独制作后固定到密封盘310的边沿313附近。这样的缓冲件314同样能够减小边沿313对体内组织造成的磨损，起到一定的缓冲作用。
在其他实施例中，请参考图13，金属线圈314呈阿基米德螺旋，且一端固定于密封盘310上，优选固定在边沿313上，金属线圈314与边沿313之间存在多处间隙，因而具有更好的缓冲效果，对体内组织的磨损会更小。
在其他实施例中，进一步地，可在实施例3的密封盘310的边沿上再包覆一些如实施例1中的薄膜体114，也即，在实施例3的密封盘310的一部分或全部的金属线圈314外再包覆至少一层薄膜体114，增加的薄膜体114优选地贴合金属线圈314的外围设置。因而，缓冲件至少包括具有弹性的金属线圈314和薄膜体114，具体组合方式不受限制。
实施例4
实施例4的封堵装置与实施例1的封堵装置100中相同的部分，在此不再赘述，两者的主要区别在于，实施例4中的缓冲件包括至少一个囊状件。囊状件可以为封闭的具有腔体的球囊，球囊可以通过注射液体而被充盈，或进一步地可在液体缓慢释放在体内后而收缩。当缓冲件为一个长条形的球囊时，球囊沿其长度方向包覆在至少一部分边沿上，优选地，球囊的长度刚好能够包覆整个边沿。当缓冲件为多个球囊时，每个球囊分别设置在边沿的不同部位，所有的球囊可以等间隔或非等间隔地固定在密封盘上。这样的缓冲件同样能够减小边沿对体内组织造成的磨损，起到一定的缓冲作用。
囊状件可采用硅橡胶、Pebax(聚醚嵌段聚酰胺)、尼龙PA11、Pebax和尼龙PA11的混合物、尼龙12、PET等材料制成。
使用时，在封堵装置释放之前，囊状件内没有填充物；在封堵装置释放后，通过导管等将填充物注入囊状件内，从而使球囊充盈起来而具有很好的缓冲作用。填充物优选为液体，例如生理盐水或其他具有良好生物相容性的液体。进一步地，可在囊状件内注入含有抗凝血或抗血小板材料的填充物，填充物可从囊状件内向体内缓慢释放，使得病人在术后无需或少服用具有抗凝血的药物。
实施例5
实施例5的封堵装置与实施例1的封堵装置100中相同的部分，在此不再赘述，两者的主要区别在于，实施例5中的缓冲件包括多个毛刷。请参考图14，毛刷514呈细条状，其一端固定于密封盘510的远端(例如通过远端套管约束 固定)，另一端为自由端，介于两端之间的部分则收容在密封盘510的内部。如图15所示，在压缩状态下，毛刷514的自由端可部分或全部收容在密封盘510的内部；如图14所示，在自然状态下，毛刷514的自由端从密封盘510的内部穿过边沿513而伸出到外部。在其他实施例中，毛刷514的一端可设置在密封盘510的近端，另一端为自由端。这样的缓冲件514同样能够减小边沿513对体内组织造成的磨损，起到一定的缓冲作用。
毛刷514可由金属丝或高分子丝构成，丝径在0.01mm至0.04mm之间。毛刷514的自由端可进一步分开为如图16中所示的分叉部分515，且分叉部分515分别朝向密封盘510弯曲，不仅能够使与体内组织接触的边沿513部分变得更柔软，还不容易存在毛刷514直接进入到密封盘510内部而出不来的情况，具有限位的作用。
在另一实施例中，请参考图17，密封盘510上设有至少一个阻流膜516，毛刷514的一端固定于阻流膜516上，另一端为自由端。例如，可在阻流膜516的边缘部分裁剪出较多的长条形作为毛刷514，当阻流膜516固定在密封盘510上后，作为毛刷514的阻流膜部分则位于密封盘510的外部，这样的阻流膜516不仅具有密封效果，还能够减少边沿513部分对体内组织的摩擦造成的损伤。
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 (10)

  1. 一种封堵装置，包括密封盘，所述密封盘包括近端盘面和远端盘面，以及连接所述近端盘面和所述远端盘面的边沿，其特征在于，所述密封盘上设有至少一个缓冲件，所述至少一个缓冲件沿着所述边沿分布，所述缓冲件至少包括以下之一：薄膜体、缝合线、金属线圈、囊状件、毛刷。
  2. 根据权利要求1所述的封堵装置，其特征在于，所述封堵装置还包括位于所述密封盘一侧的固定盘，所述固定盘的一端与所述密封盘连接，另一端朝向远端径向辐射出后再朝向近端延伸。
  3. 根据权利要求1或2所述的封堵装置，其特征在于，所述至少一个缓冲件围绕所述边沿至少一圈；或者，当所述缓冲件有多个时，多个所述缓冲件在所述边沿上间隔分布。
  4. 根据权利要求3所述的封堵装置，其特征在于，所述缓冲件为所述薄膜体，所述薄膜体贴合所述边沿进行固定。
  5. 根据权利要求3所述的封堵装置，其特征在于，所述缓冲件为所述薄膜体，所述薄膜体的沿其长度方向的两个边缘分别固定在所述密封盘上，且在所述薄膜体与所述边沿之间形成一个空腔。
  6. 根据权利要求4或5所述的封堵装置，其特征在于，所述近端盘面的至少一部分和/或所述远端盘面的至少一部分包覆有薄膜体。
  7. 根据权利要求1所述的封堵装置，其特征在于，所述边沿为位于所述近端盘面与所述远端盘面之间的朝向外部的圆滑凸沿。
  8. 根据权利要求1所述的封堵装置，其特征在于，所述金属线圈的至少一端固定于所述密封盘上，且所述金属线圈的至少一部分与所述边沿之间存在间隙。
  9. 根据权利要求1所述的封堵装置，其特征在于，所述毛刷的一端固定于所述密封盘的近端或远端，另一端为自由端。
  10. 根据权利要求1所述的封堵装置，其特征在于，所述密封盘上设有至少一个阻流膜，所述毛刷的一端固定于所述阻流膜上，另一端为自由端。
PCT/CN2020/120077 2019-10-15 2020-10-10 封堵装置 Ceased WO2021073453A1 (zh)

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