WO2020093926A1 - 封堵器 - Google Patents

封堵器 Download PDF

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Publication number
WO2020093926A1
WO2020093926A1 PCT/CN2019/114704 CN2019114704W WO2020093926A1 WO 2020093926 A1 WO2020093926 A1 WO 2020093926A1 CN 2019114704 W CN2019114704 W CN 2019114704W WO 2020093926 A1 WO2020093926 A1 WO 2020093926A1
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WO
WIPO (PCT)
Prior art keywords
distal
proximal
occluder
suture
sealing
Prior art date
Application number
PCT/CN2019/114704
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English (en)
French (fr)
Inventor
张�杰
陈贤淼
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
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
Publication of WO2020093926A1 publication Critical patent/WO2020093926A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—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

Definitions

  • the invention relates to the field of medical equipment, in particular to an occluder.
  • Cardiac defect occluder (hereinafter referred to as occluder) is an implantable medical device for the treatment of congenital heart defects.
  • the implantation process of the occluder usually needs to be operated under the guidance of X-ray imaging equipment such as DSA (Digital Subtraction Angiography). Therefore, the occluder is required to have good visibility under X-ray Sex.
  • DSA Digital Subtraction Angiography
  • the traditional occluder is usually made of nickel-titanium alloy and other metals, and its visibility under DSA equipment is better.
  • the occluder made of polymer materials has poor radiation non-projection under X-rays, which results in poor visibility. It is difficult to determine the exact position and release state of the occluder under DSA. Therefore, for an occluder made of a polymer material, it is usually necessary to provide a marking structure on the occluder to assist in determining the accurate position and release state of the occluder.
  • Existing occluders made of polymer materials generally embed the marking structure in the distal and / or proximal heads of the occluder.
  • the marking structure is wrapped inside the distal head and / or the proximal head. During the delivery process, the marking structure and the inner wall of the sheath can be prevented from rubbing and scratching, which can cause the marking structure to go from the distal head and / or the proximal end.
  • the head is off.
  • the marking structure is embedded on the distal head and / or proximal head. Under the DSA equipment, only the approximate position of the distal head and / or proximal head can be determined, and it is difficult to determine the overall occluder. The exact relative position of the morphology and occluder to the defect.
  • An occluder includes a support net, a distal head and a proximal head.
  • the distal head and the proximal head are respectively disposed at both ends of the support net, and the distal head is embedded It is provided with a distal marking structure, and further includes a sealing film provided in the support net, and a first marking structure is provided on the surface of the sealing film.
  • the above-mentioned occluder is provided with a distal marking structure on the distal head and a first marking structure in the occluded membrane.
  • the combination of the distal marking structure and the first marking structure is beneficial to determine the overall shape and occluder of the occluder The exact relative position of the device and the defect.
  • the distal marking structure is embedded in the distal head, and the first marking structure is located inside the bag-like structure formed by the blocking film, which can avoid the distal marking structure and the first marking structure directly from the sheath Contact, so as to avoid the phenomenon that the distal marking structure and the first marking structure rub against or rub against the inner wall of the sheath tube and cause the distal marking structure and the first marking structure to fall off.
  • FIG. 1 is a schematic structural diagram of an occluder according to an embodiment
  • FIG. 2 is a schematic structural diagram of a first distal disc surface of the occluder shown in FIG. 1;
  • FIG. 3 is a schematic structural view of a blocking film of the blocking device shown in FIG. 1;
  • FIG. 4 is a schematic diagram of the occluder shown in FIG. 1 in the sheath;
  • FIG. 5 is a schematic structural view of the occluder shown in FIG. 1 in a stretched state
  • FIG. 6 is a partial enlarged view of FIG. 2;
  • FIG. 7 is a schematic structural diagram of a first distal disc surface of an occluder according to another embodiment
  • FIG. 8 is a partial enlarged view of FIG. 7;
  • FIG. 9 is a schematic diagram of the alignment of the second suture according to an embodiment
  • FIG. 10 is a schematic diagram of a fixing manner of the sealing film, the proximal sealing film, and the central sealing film according to an embodiment
  • FIG. 11 is a schematic view of a state in which the sealing film of the sealing device shown in FIG. 1 is fixed on the first proximal disk surface;
  • 12a to 12d are schematic diagrams of the release process of the occluder according to an embodiment
  • FIG. 13a to 13d are schematic diagrams of the manner in which the first marking structure of the occluder of the embodiment is arranged on the occluder film;
  • FIGS. 13b and 13c are schematic diagrams of the release state of the occluder of the embodiment shown in FIGS. 13b and 13c;
  • 15 is a schematic diagram of a fixing method of a sealing film of an occluder according to an embodiment.
  • an occluder 100 includes a support net 10, a distal head 20, a proximal head 30 and an occluder 40.
  • the distal head 20 and the proximal head 30 are respectively disposed at both ends of the support net 10.
  • the blocking film 40 is provided in the support net 10.
  • the support net 10 includes a distal sealing unit 11, a proximal sealing unit 12, and a waist 13, and both ends of the waist 13 are connected to the distal sealing unit 11 and the proximal sealing unit 12, respectively.
  • the widths of the distal blocking unit 11 and the proximal blocking unit 12 are larger than the width of the waist 13.
  • the support mesh 10 In the natural state (also the state of blocking the heart defect), the support mesh 10 has a structure that is large at both ends and small at the middle.
  • the end plugging unit 11 and the proximal plugging unit 12 have a circular shape, and the waist 13 has a substantially cylindrical shape.
  • the distal blocking unit 11 includes a first distal disk surface 111, a first proximal disk surface 112, and a first ridge 113 connecting the first distal disk surface 111 and the first proximal disk surface 112.
  • the proximal blocking unit 12 includes a second distal disk surface 121, a second proximal disk surface 122, and a second ridge 123 connecting the second distal disk surface 121 and the second proximal disk surface 122.
  • the distal sealing head 20 is disposed on the distal sealing unit 11, the proximal sealing head 30 is disposed on the proximal sealing unit 12, and the sealing film 40 is disposed in the distal sealing unit 11.
  • a distal marking structure 51 is provided in the distal head 20.
  • the distal marking structure 51 is used to mark the position of the distal blocking head 20 during implantation.
  • the material of the distal marking structure 51 is a material visible under X-ray imaging equipment such as DSA. It can be a metallic or non-metallic material that is visible under X-ray imaging equipment such as DSA.
  • the material of the distal marking structure 51 is at least one of platinum, platinum alloy, gold, tantalum, iron, tungsten, stainless steel, nickel-titanium alloy, cobalt-chromium alloy, gold alloy, tungsten-based alloy, and iron-based alloy.
  • the material of the distal marking structure 51 may also be non-metallic materials such as sodium bromide and sodium iodide.
  • the shape of the distal marking structure 51 is not limited, and it can meet the setting requirement of the distal marking structure 51 embedded in the distal head 20. Such a setting can avoid the transportation under the premise of meeting the requirements of visibility. During the process, the distal marking structure 51 falls off.
  • the occluder 100 also includes a lock 50.
  • the locking member 50 is disposed in the support net 10, and one end of the locking member 50 is fixedly connected to the distal head 20, and the other end is detachably connected to the proximal head 30.
  • the proximal head 30 is provided with a through hole. When the locking member 50 is connected to the proximal head 30 through the through hole, the distance between the distal blocking unit 11 and the proximal blocking unit 12 is fixed.
  • the support net 10 has a woven structure.
  • the support net 10 is formed by cross-weaving a plurality of polymer filaments, and the plurality of polymer filaments cross to form a plurality of loop crossing points.
  • Each circle of intersections includes multiple intersections, and multiple intersections of the same circle of intersections are evenly distributed along the circumference of the circle (that is, the distance between two adjacent intersections are equal), each intersection is composed of Two sets of braided wires with different rotation directions are crossed.
  • the free ends of the distal ends of the polymer filaments of the support mesh 10 converge and are fixed in the distal head 20, and the proximal free ends of the polymer filaments converge and are fixed in the proximal head 30.
  • the material of the polymer filament can be degradable such as polylactic acid (PLA), polyglycolic acid (PGA), polyhydroxy fatty acid ester (PHA), polydioxanone (PDO) or polycaprolactone (PCL) material.
  • PLA polylactic acid
  • PGA polyglycolic acid
  • PHA polyhydroxy fatty acid ester
  • PDO polydioxanone
  • PCL polycaprolactone
  • the support mesh 10 may be woven from metal wires, for example, woven from nickel-titanium alloy wires.
  • the distal plugging unit 11, the proximal plugging unit 12, and the waist 13 of the support mesh 10 are all mesh structures.
  • the braided wires of the first distal disc surface 111 cross to form a multi-turn intersection point
  • the multi-turn intersection point includes the outermost circle intersection point 110 (the circle indicated by the dotted line of the outermost circle in FIG. 2) and The first circle of intersections 120 (the circle indicated by the dotted line of the innermost circle in FIG. 2) closest to the intersection 110.
  • Multi-turn intersections also include second-turn intersections, third-turn intersections, etc. The second-turn intersections are located in the inner circle of the first-turn intersection, the third-turn intersections are located in the inner circle of the second-turn intersection, and so on .
  • the first proximal disk surface 112, the second distal disk 121, and the second proximal disk surface 122 are knitted in the same manner as the first distal disk surface 111, and all include the outermost circle intersection point, which is farther from the outermost circle intersection point
  • the second lap intersection is located in the inner ring of the first lap intersection
  • the third lap intersection is located in the inner ring of the second lap intersection. And so on, will not repeat them here.
  • the sealing film 40 is a circular sheet-like structure, and the size of the sealing film 40 is adapted to the size of the remote sealing unit 11, so that the sealing film 40 is provided at the remote sealing unit At 11 o'clock, the outer peripheral surface 41 of the occluder 40 abuts the inner surface of the first ridge 113 of the distal occluder unit 11 (as shown in FIG. 1), which helps to improve the occluder effect and avoid the occluder 100 Residual shunt occurs after implantation.
  • the sealing film 40 is fixed in the distal sealing unit 11.
  • the occluder 100 further includes a first suture 211 and a second suture 212.
  • the sealing film 40 is fixedly connected to the distal sealing unit 11 through the first suture 211 and the second suture 212, and the first suture 211 is closer to the edge of the first distal sealing unit 11 than the second suture 212. That is, when the first suture 211 is closer to the outer peripheral surface 41 of the sealing film 40 than the second suture 212, so that the occluder 100 is loaded in the sheath 200 in a stretched state (as shown in FIG. 4), The center of the sealing film 40 extends toward the distal head 20, and the edge of the sealing film 40 shrinks to form a bag-like structure (as shown in FIGS. 4 and 5).
  • the sealing film 40 is sutured to the outermost intersection 110 and the first intersection 120 of the first distal disc surface 111 through the first suture 211.
  • the stitching position of a suture 211 on the sealing film 40 is shown as the circle 410 and the circle 420 in FIG. 3.
  • the small circles on the circumference 410 and the circumference 420 represent specific stitching points.
  • the plurality of intersection points 2112 of the first suture 211 and the distal blocking unit 11 are distributed on the outermost circle intersection 110 and the first circle intersection 120, that is, they are not on the same circumference and not on the same cross section.
  • the blocking membrane 40 is easily displaced and deformed. After being implanted in the human body, the blocking membrane 40 will be poorly attached to the heart defect, resulting in residual shunting.
  • the effect of the above-mentioned external force comes from the pushing effect of the sheath port on the intersection 2112 of the first suture 211 and the distal blocking unit 11 during the process of retracting the occluder 100 into the sheath 200, resulting in the grid following the intersection 2112 Displacement deformation, the edge of the sealing film 40 will also have displacement deformation, curling and other phenomena.
  • the first suture 211 and the plurality of intersection points 2112 of the distal blocking unit 11 are staggered so that the first suture 211 and the plurality of intersection points 2112 of the distal blocking unit 11 are not on the same circumference.
  • the force of the sheath port on the intersection 2112 during the sheath insertion process of the occluder 100 can be dispersed, and the force can be dispersed on different cross sections, thereby reducing the sheath port opening on the first suture 211 and the seal
  • the nozzle pushes the intersection 2112 to cause the intersection of the first suture 211 and the sealing film 40 to be displaced toward the distal end of the occluder 100, which can effectively reduce
  • the first suture 21 is a continuous suture, and in other embodiments, the first suture 21 may be a discontinuous suture.
  • the first suture 211 and the distal blocking unit 11 form a plurality of discrete intersection points 2112, and there is no connection between any two intersection points 2112.
  • the plurality of intersection points 2112 of the first suture 211 and the distal blocking unit 11 may be located on the same circumference, or may be distributed on different circumferences. Even if the plurality of intersection points 2112 of the first suture 211 and the distal blocking unit 11 can be located on the same circumference, the possibility of the curling phenomenon of the blocking film 40 can be reduced.
  • intersection points 2112 of the plurality of first stitches 211 on the outermost circle intersection point 110 are distributed at equal intervals.
  • the intersection points 2112 of the plurality of first stitches 211 on the intersection point 120 of the second circle are distributed at equal intervals.
  • intersection points 2112 of the plurality of first stitches 211 on the outermost circle intersection point 110 may be distributed at non-equidistant intervals.
  • the intersection points 2112 of the plurality of first sutures 211 on the intersection point 120 of the second circle may be distributed at equal intervals or at non-equidistant intervals.
  • all the intersection points of the braided wire are the intersection points 2112 of the first suture 211 and the first distal disc surface 111, that is, at the intersection point 110 of the outermost circle, all of the braided wire
  • the intersection points are all wrapped by the first suture 211.
  • all the crossing points of the braided wire are the intersection points 2112 of the second suture 212 and the first distal disc 111, that is, at the crossing point 120 of the first loop, all the crossing points of the braiding wire are A suture 211 is wound.
  • first suture 211 When sewing, take the first suture 211 as an example, first hook a certain intersection point of the selected outermost intersection point 110, and then thread to the intersection point adjacent to the second circle intersection point 120 to hook it , Then go to the intersection point adjacent to the outermost intersection point 110 to hook it, and then go to the second circle intersection point 120 to neighboring intersection point to hook it, so alternately hook two circles of intersection nodes, repeat the above actions , After the needle moves along the circumference for a week, the two thread ends are knotted.
  • the stitching method may be stitched at one or several crossing points, instead of each crossing point intersecting the first stitch 211 or the second stitch 222. Please refer to FIG. 7 and FIG. 8 together.
  • the stitching method of the first stitch 211 is that the first stitch 211 is stitched at an intersection on the outermost circle intersection 110, and the first stitch 211 is stitched at the second circle intersection 120 The upper is also stitched at a crossing point.
  • the sealing film 40 is fixed in the distal sealing unit 11, it can be
  • the force of the sheath nozzle on the intersection 2112 when the occluder 100 is inserted into the sheath is reduced, because the fewer the intersection 2112 on the same circumferential section, the smaller the force, and the lower the possibility of displacement and deformation of the occluder membrane 40.
  • the second suture 212 may form only one intersection with the distal blocking unit 11 (as shown in FIG. 5), or may form multiple intersections with the distal blocking unit 11, as shown in FIG.
  • the second suture 212 may be a continuous suture and form multiple intersections with the distal blocking unit 11 as shown in FIGS. 9 and 10.
  • the intersection point of the second suture 212 and the distal blocking unit 11 is not on the same circumference, but is distributed on two circles, and the intersection point of the second suture 212 and the distal blocking unit 11 are both
  • the geometric center of the sealing film 40 is closer to the intersection of the first suture 211 and the distal sealing unit 11.
  • the second suture 212 is a discontinuous suture.
  • the second suture 212 and the distal blocking unit 11 form a plurality of discrete intersections, and there is no connection between any two intersections.
  • the second suture 212 is closer to the geometric center of the sealing film 40 than the first suture 211, and the second suture 212 and the first suture 211 are provided at the same time as described above, which can ensure that the occluder 100 is in a stretched state.
  • the center of the sealing film 40 extends toward the distal head 20, and the edge of the sealing film 40 contracts to form a bag-like structure.
  • the second suture 212 is a continuous suture or forms multiple crossing points with the second suture 212 and the distal sealing unit 11, it is advantageous to improve the reliability of the sealing film 40 shrinking into the above-mentioned bag-like structure. Further, when the intersection point of the second suture 212 and the distal sealing unit 11 is not on the same circle, but is distributed on two circles, the reliability of the sealing film 40 shrinking into the above-mentioned bag-like structure is higher.
  • the sealing film 40 is fixedly connected to the first distal disc surface 111 of the distal sealing unit 11 through the first suture 211 and the second suture 212, and the sealing film 40 is connected to the distal sealing unit
  • the first proximal disk surface 112 of 11 is not fixedly connected.
  • the sealing membrane 40 is only in physical contact with the first proximal disk surface 112 of the distal sealing unit 11.
  • the stitching points of the first suture 211 on the sealing film 40 are respectively on the circumference 410 and the circumference 420, wherein the distance between the circumference 410 and the outer peripheral surface 41 of the sealing film 40 (with the sealing film 40 The distance of the outer edge) is 1 to 2 mm, to ensure that the first suture 211 and the sealing film 40 are reliably stitched without causing the first suture 211 to fall off the edge of the sealing film 40, and to avoid the sealing film 40 There is a curling phenomenon.
  • the middle portion of the sealing membrane 40 is provided with a distal through hole 42.
  • the diameter of the distal through hole 42 is adapted to the size of the locking member 50, so that the proximal end of the locking member 50 can pass through the distal through hole 42 and
  • the proximal head 30 is detachably connected.
  • the distal through hole 42 is a circular hole.
  • the diameter of the distal through-hole 42 is 0.5 to 1 mm, so as to ensure that the locking member 50 can pass through, and avoid too large an opening to affect the sealing effect of the sealing film 40.
  • the distal through-hole 42 is not limited to a circular hole, and may be a through-hole of other shapes, for example, a square hole, a bar-shaped hole, a cross slit, and the like.
  • the occluder 100 further includes a first marking structure 52.
  • the first marking structure 52 is disposed on the sealing film 40, and the first marking structure 52 is disposed on the surface of the sealing film 40 near the proximal head 30. Please refer to FIG. 5.
  • the first marking structure 52 includes two first markers 522 spaced apart. In a natural state, the connection between the two first markers 522 and the distal marking structure 51 is triangular.
  • a distal marking structure 51 and two first markers 522 can be formed A triangle, as shown in Figure 12a.
  • the surgeon pulled the occluder 100 to move proximally to bring it closer to the interatrial septum 2 position.
  • the two first markers 522 and the distal marking structure 51 The connection is still triangular, as shown in Figure 12b.
  • the distal marker The shape of the triangle formed by the structure 51 and the two first markers 522 will change, as shown in FIG. 12c, until three points form a line. If the occluder 100 continues to be pulled at this time, the distal head 20 may cross the position of the atrial septal defect, which may easily cause the occluder 100 to fall off, as shown in FIG. 12d.
  • the distal marking structure 51 and the first marking structure 52 including two first markers 522 are provided, and in a natural state, the connection line between the two first markings 522 and the distal marking structure 51 is formed into a triangle, When the triangle changes into a straight line during the operation, it means that the occluder 100 and the interatrial septum 2 have a good adhesion, and the pulling operation can be stopped to continue releasing the proximal occluder unit 12 of the occluder 100.
  • the distal marking structure 51 and the first marking structure 52 including two first markers 522 are provided, and in a natural state, the connection between the two first markers 522 and the distal marking structure 51 is triangular, which is beneficial to
  • the occluder 100 is accurately positioned to obtain a better occluder effect.
  • the occluder 100 can be prevented from falling off due to inaccurate positioning, and the safety of clinical application is improved.
  • the two first markers 522 are located at the edge of the sealing film 40, and the length of the connection line of the two first markers 522 is equal to the diameter of the sealing film 40, ie The two first markers 522 are at both ends of the same diameter of the blocking film 40.
  • Such setting is more conducive to accurately positioning the occluder 100, so as to improve the occluding effect and improve the safety of clinical application.
  • the two first markers 522 are located at two points at the maximum distance in the radial direction of the blocking film 40, and the line connecting the two first markers 522 passes through the sealing
  • the geometric center of the blocking film 40 is helpful for accurately determining that the occluder 100 adheres to the defect.
  • the two first markers 522 are still located at the maximum distance of the blocking film 40 in the radial direction Two points.
  • the blocking film 40 is elliptical, two first markers 522 are located at both ends of the long axis of the oval blocking film 40.
  • the first marker 522 is a circular metal sheet.
  • it can be a round gold plate, a platinum plate, a stainless steel plate, or the like.
  • the thickness of the metal sheet is 50-500 microns, and the diameter is 100-600 microns, to ensure the visibility of the occluder 100 under X-ray imaging equipment such as DSA, and the metal sheet is not too large to affect Delivery of the occluder 100.
  • the first marking structure 52 is fixed on the surface of the sealing film 40 near the proximal head 20 by means of adhesive bonding. In this way, the processing is relatively simple and the preparation efficiency is high.
  • the number of first markers 522 is not limited to two, and may be more.
  • the number of first markers 522 is an even number in the range of 2-12.
  • a plurality of first markers 522 are arranged at intervals, and the plurality of first markers 522 are located on the same diameter of the sealing film 40, and the two first markers 522 with the largest distance are located at the Both ends of the diameter.
  • the sheath tube 200 is a cylindrical tube and has no directionality, during the operation, when the distal blocking unit 11 of the occluder 100 is released, a plurality of A marker 522, which can ensure the connection between the two first markers 522 with the largest distance in the occluder 100 along the line VI-VI in FIG. 5, that is, the diameter and locking of the two first markers 522
  • the piece 50 is vertical, so that the connection line between the two first markers 522 with the largest distance and the distal marking structure 51 forms a triangle. In this way, the surgical operation is relatively simple, which is beneficial for reducing the operation of adjusting the angle of X-ray imaging equipment such as DSA, and enables the occluder 100 to be positioned more quickly.
  • the plurality of first markers 522 are distributed circumferentially, as shown in FIG. 13c.
  • the number of the first markers 522 is an even number greater than 2, and the even number of the first markers 522 greater than 2 are disposed on the sealing film 40 in pairs, and the connection line of each pair of the first markers 522 passes through The geometric center of the sealing film 40. Since the sheath tube 200 is a cylindrical tube and has no directionality, during the operation, when the distal blocking unit 11 of the occluder 100 is released, a plurality of first markers 522 are arranged symmetrically in the above manner. It can be ensured that the cross-section along the line VI-VI in FIG.
  • the connecting line between the two first markers 522 of the occluder 100 is perpendicular to the locking member 50, so that the two The connection between the first marker 522 with the largest distance and the distal marker structure 51 is triangular.
  • the operation of adjusting the angle of X-ray imaging equipment such as DSA can also be reduced, and the occluder 100 can be positioned relatively quickly.
  • the number of the first markers 522 may also be an odd number, as long as at least two first markers 522 and the distal marking structure 51 are connected in a triangle.
  • the first marking structure 52 may also have a ring shape, as shown in FIG. 13d.
  • the first marking structure 52 is a ring-shaped metal sheet
  • the outer ring diameter of the ring-shaped metal sheet is equal to the diameter of the sealing film 40
  • the outer ring diameter of the ring-shaped metal sheet is smaller than the diameter of the sealing film 40
  • the outer edge of the ring-shaped metal sheet is disposed close to the outer edge of the sealing film 40 or the outer edge of the ring-shaped metal sheet coincides with the outer edge of the sealing film 40. In this way, it can also be ensured that in a natural state, in a section along the line VI-VI in FIG. 5, the line connecting the two points with the largest distance of the first marking structure 52 of the occluder 100 is perpendicular to the locking member 50, Therefore, the connection between the two ends of the ring-shaped metal sheet and the distal marking structure 51 is triangular.
  • the two first markers 522 with the largest distance are located at both ends of the diameter or the plurality of first markers 522 are distributed circumferentially At this time, a triangle can be formed between the distal marking structure 51 and the plurality of first markers 522, which is beneficial to the accurate release of the occluder 100.
  • the above-mentioned occluder 100 is provided with a distal marking structure 51 on the distal head 20 and a first marking structure 52 in the sealing film 40.
  • the distal marking structure 51 is embedded in the distal head 20, and the first marking structure 52 is located inside the bag-like structure formed by the blocking film 40, which can avoid the distal marking structure 51 and the first marking
  • the structure 52 is in direct contact with the sheath 200, thereby avoiding the phenomenon that the distal marking structure 51 and the first marking structure 52 rub against or rub against the inner wall of the sheath 200, causing the distal marking structure 51 and the first marking structure 52 to fall off.
  • the support mesh 10 of the occluder 100 has a structure of two plates and one waist.
  • the support mesh 10 may have other structures, such as a T-shaped cross-section. , Including the sealing disc and the waist connected to the sealing disc, at this time the sealing film 40 is disposed in the sealing disc.
  • the occluder 100 further includes a proximal occluded membrane 60 to further improve the occluded effect and avoid the phenomenon of residual shunting.
  • the proximal blocking film 60 is provided in the proximal blocking unit 12.
  • the proximal sealing film 60 is also a circular sheet-like structure, and the size of the proximal sealing film 60 is adapted to the size of the proximal sealing unit 12, so that the proximal sealing film 60 is provided on the proximal seal
  • the outer peripheral surface of the proximal occlusion membrane 60 abuts the inner surface of the second ridge 123 of the proximal occlusion unit 12, which is beneficial to improve the occlusion effect and avoid the occurrence of the occlusion device 100 after implantation Residual diversion.
  • the proximal blocking film 60 is fixed in the proximal blocking unit 12.
  • the occluder 100 further includes a third suture 213 and a fourth suture 214.
  • the proximal sealing film 60 is fixedly connected to the proximal sealing unit 12 through the third suture 213 and the fourth suture 214, and the third suture 213 is closer to the outer periphery of the proximal sealing film 60 than the fourth suture 214.
  • the fixing method of the proximal blocking film 60 in the proximal blocking unit 12 is substantially the same as the fixing method of the blocking film 40 in the distal blocking unit 11.
  • the proximal sealing film 60 is sutured at the intersection of the outermost circle and the intersection of the first circle of the second distal disc surface 121 by the third suture 213.
  • the intersection of the third suture 213 and the proximal plugging unit 12 is distributed at the intersection of the outermost circle and the intersection of the first circle, that is, not on the same circumference and not on the same cross section.
  • the plurality of intersection points of the third suture 213 and the proximal plugging unit 12 are shifted so that the plurality of intersection points of the third suture 213 and the proximal plugging unit 12 are not on the same circumference.
  • the force of the sheath port on the intersection point during the sheath insertion of the occluder 100 can be dispersed, and the force can be dispersed on different cross-sections, thereby reducing the sheath port on the third suture 213 and the proximal end during the sheath insertion
  • the resistance and squeezing effect of the sealing film 60 and at the same time, because the number of intersections of the same cross section is reduced, the number of points of action of the sheath port on the third suture 213 is greatly reduced, and the sheath 100 is retracted due to the sheath
  • the orifice pushes the intersection point, so that the intersection of the third suture 213 and the proximal sealing film 60 may be displaced toward the distal
  • the fourth suture 214 may form only one intersection with the proximal blocking unit 12, or may form multiple intersections with the proximal blocking unit 12.
  • the fourth suture 214 may be a continuous suture and form multiple intersections with the proximal blocking unit 12.
  • the intersection of the fourth suture 214 and the proximal plugging unit 12 is not on the same circle, but is distributed on two circles.
  • the fourth suture 214 is a discontinuous suture.
  • the fourth suture 214 and the proximal plugging unit 12 form a plurality of discrete intersections, and there is no connection between any two intersections.
  • the proximal sealing film 60 is fixedly connected to the second distal disc surface 121 of the proximal sealing unit 12 through the third suture 213 and the fourth suture 214, and the proximal sealing film 60 and the proximal
  • the second proximal disk surface 122 of the end plugging unit 12 is not fixedly connected, and the two are only in physical contact. In this way, when the occluder 100 is axially stretched, the phenomenon that the edge of the proximal occluder film 60 is turned over to form two layers of curling can be avoided.
  • the stitching point of the third suture 213 on the proximal sealing film 60 is on the same circumference, and the distance between the circumference and the outer peripheral surface of the proximal sealing film 60 is 1 to 2 mm to ensure that the third suture 213 is close to
  • the end sealing film 60 is sutured reliably without generating the third suture 213 from falling off the edge of the proximal sealing film 60, and at the same time avoiding the curling phenomenon of the proximal sealing film 60.
  • the third suture 213, the fourth suture 214, the proximal sealing film 60 and the second distal disc surface 121 can be fixed and routed according to the first suture 211 and the second suture 212 described above 1.
  • the blocking film 40 and the first distal disk surface 111 are fixed and routed.
  • the third suture 213, the fourth suture 214, the proximal sealing film 60 and the second distal disc surface 121 are fixed and routed in the same manner as the first
  • the fixing method and the routing method of the suture 211, the second suture 212, the sealing film 40 and the first distal disc surface 111 may be the same or different.
  • all the intersection points of the braided wire are wound by the first suture 211, and at the intersection point of the outermost circle of the second distal disc surface 121, it may be All the crossing points of the braided wire are wrapped by the third suture 213, or only a part of the crossing points of the braided wire are wrapped by the third suture 213.
  • the proximal blocking film 60 has a proximal through hole in the middle for the locking member 50 to pass through.
  • the shape of the proximal through hole is not limited, and may be the same as the shape of the distal through hole 42 or different.
  • the diameter of the proximal through hole is 0.5 to 1 mm.
  • the occluder 100 further includes a second marking structure 53.
  • the second marking structure 53 is provided on the surface of the proximal sealing film 60 near the proximal head 30 so that in the stretched state, the second marking structure 53 is located inside the bag-like structure formed by the proximal sealing film 60.
  • the structure of the second marking structure 53 is the same as that of the first marking structure 52, and the second marking structure 53 is fixed on the surface of the proximal sealing film 60 near the proximal head 20 by means of adhesive bonding.
  • the second marking structure 53 includes a plurality of second markers 532.
  • the second marker 532 is a circular metal sheet with a thickness of 50 to 500 microns and a diameter of 100 to 600 microns.
  • the second marking structure 53 includes an even number of second markers 532 in the range of 2-12, a plurality of second markers 532 are arranged at intervals along the circumference, and the even number of second markers 532 are arranged in pairs on the proximal seal On the blocking membrane 60, the line of each pair of second markers 532 passes through the geometric center of the proximal blocking membrane 60.
  • a plurality of second markers 532 are arranged on the same diameter of the proximal occlusion membrane 60 at intervals, and the two second markers 532 with the largest distance are located at both ends of the diameter.
  • the number of the second markers 532 is two, the two second markers 532 are at both ends of the same diameter of the proximal blocking film 60, and the connection line of the two second markers 532 passes through The geometric center of the proximal blocking membrane 60.
  • the number of the second markers 532 may also be an odd number, as long as at least two second markers 532 and the distal marking structure 51 are connected in a triangle.
  • the second marking structure 53 has a ring shape.
  • the second marking structure 53 is a ring-shaped metal sheet.
  • the size of the second mark structure 53 and the position of the second mark structure 53 on the proximal blocking film 60 are the same as the size of the first mark structure 52 and the position of the first mark structure 52 on the blocking film 40 I will not repeat them here.
  • the occluder 100 further includes a central occluder film 70 to further improve the occluder effect and avoid residual shunting.
  • the middle blocking film 70 is provided in the waist 13.
  • the middle blocking film 70 is also a circular sheet-like structure, and the size of the middle blocking film 70 is adapted to the size of the waist 13 so that when the middle blocking film 70 is disposed in the waist 13, the middle blocking film 70
  • the outer peripheral surface of the abutment with the inner surface of the waist 13 is beneficial to improve the sealing effect and avoid residual shunting after the occluder 100 is implanted.
  • the occluder 100 further includes a fifth suture 215 and a sixth suture (not shown in FIG. 10).
  • the central sealing film 70 is fixedly connected to the waist 13 through the fifth suture 215 and the sixth suture, and the fifth suture 215 is closer to the distal head 20 than the sixth suture, so that the occluder 100 is stretched
  • the center of the middle sealing film 70 extends toward the distal head 20, and the edge of the middle sealing film 70 contracts to form a bag-like structure.
  • the fixing method of the middle blocking film 70 in the waist 13 is substantially the same as the fixing method of the blocking film 40 in the distal blocking unit 11.
  • the middle blocking film 70 is sewn at the intersection of the two adjacent loops of the middle of the waist 13 by the fifth suture 215.
  • the intersection of the fifth suture 215 and the waist 13 is not on the same circumference or on the same cross section.
  • the plurality of intersections of the fifth suture 215 and the waist 13 are shifted so that the plurality of intersections of the fifth suture 215 and the waist 13 are not on the same circumference.
  • the force of the sheath port on the suture intersection point during the sheath insertion process of the occluder 100 can be dispersed, and the force can be dispersed on different cross-sections, thereby reducing the sheath port on the fifth suture 215 and The resistance and squeezing effect of the middle blocking membrane 70, and because the number of intersections of the same cross section is reduced, the number of points of action of the sheath port on the fifth suture 215 is greatly reduced, and the sheath 100 is retracted into the sheath due to the sheath.
  • the possibility that the intersection of the fifth suture 215 and the middle blocking film 70 is displaced toward the distal end of the occluder 100 by pushing the intersection point of the nozzle orifice can effectively reduce the possibility of the curling phenomenon of the middle blocking film
  • the intersection of the fifth suture 215 and the waist 13 may be located on the same circumference. Since the diameter of the waist 13 is relatively small, the size of the central occlusion membrane 70 is also relatively small. When the occlusion device 100 is stretched into the sheath, compared with the distal occlusion unit 11 and the proximal occlusion unit 12 When the waist portion 13 enters the sheath tube 200, a large sheathing force will not be generated. In addition, since the waist 13 is substantially cylindrical, it is difficult for the central sealing film 70 to be strictly adhered to the waist 13. Compared with the distal sealing unit 11 and the proximal sealing unit 12, the mesh deformation is not likely to occur The middle blocking film 70 is displaced or curled.
  • the sixth suture may form only one intersection with the waist 13 or multiple intersections with the waist 13.
  • the sixth suture may be a continuous suture and form multiple intersections with the waist 13.
  • the intersection point of the sixth suture and the waist 13 is not on the same circle, but is distributed on two circles.
  • the sixth suture is a discontinuous suture, the sixth suture 216 and the waist 13 form a plurality of discrete intersections, and there is no connection between any two intersections.
  • a middle through hole is opened in the middle of the middle blocking film 70 for the locking member 50 to pass through.
  • the shape of the middle through hole is not limited, and may be the same as the shape of the through hole 42 or may be different.
  • the diameter of the central through hole is 0.5 to 1 mm.
  • the locking member 50 passes through the distal through hole 42, the middle through hole, and the proximal through hole in this order to be detachably connected to the proximal head 30.
  • the occluder 100 further includes a third marking structure 54.
  • the third marking structure 54 is provided on the surface of the middle sealing film 70 near the proximal head 30 so that in the stretched state, the third marking structure 54 is located inside the bag-like structure formed by the middle sealing film 70.
  • the structure of the third marking structure 54 is the same as the structure of the first marking structure 52, and the third marking structure 54 is fixed on the surface of the middle sealing film 70 near the proximal head 30 by means of adhesive bonding.
  • the third marking structure 54 includes a plurality of third markers 542.
  • the third marker 542 is a circular metal sheet with a thickness of 50 to 500 microns and a diameter of 100 to 600 microns.
  • the third marking structure 54 includes an even number of third markers 542 in the range of 2-12, a plurality of third markers 542 are arranged at intervals along the circumference, and the even number of third markers 542 are paired in pairs Is disposed on the middle sealing film 70, and the line of each pair of third markers 542 passes through the geometric center of the middle sealing film 70.
  • a plurality of third markers 542 are arranged at intervals on the same diameter of the middle blocking film 70, and the two third markers 542 with the largest distance are located at both ends of the diameter.
  • the number of the third markers 542 is two, the two third markers 542 are at both ends of the same diameter of the middle blocking film 70, and the connection line of the two third markers 542 passes through the middle seal The geometric center of the blocking membrane 70.
  • the number of the third markers 542 may also be an odd number, as long as at least two third markers 542 are connected to the distal marking structure 51 in a triangular shape.
  • the third marking structure 54 has a ring shape.
  • the third marking structure 54 is a ring-shaped metal sheet.
  • the size of the third marking structure 54 and the position of the third marking structure 54 on the central sealing film 70 are the same as the size of the first marking structure 52 and the position of the first marking structure 52 on the sealing film 40. This will not be repeated here.
  • the occluder 100 further includes a proximal marking structure 55 embedded in the proximal head 30.
  • the proximal head 30 is detachably connected to the delivery cable 300.
  • the proximal head 30 is fixedly connected to the delivery cable 300 (as shown in FIG. 4).
  • the proximal head 30 is separated from the delivery cable 300.
  • the provision of the proximal marking structure 55 can assist in identifying the overall shape of the occluder 100, and is beneficial to determine whether the occluder 100 is smoothly separated from the delivery cable 300 to ensure the smooth progress of the implantation operation.
  • the distal marking structure 51 and the proximal marking structure 55 are provided at the same time, which is beneficial to the recovery of the occluder 100.
  • proximal marking structure 55 may be embedded in the wall of the proximal head 30 or may be embedded in the inner cavity of the proximal head 30.
  • the proximal marking structure 55 has a ring shape, so that the locking member 50 can pass through the proximal head 30.
  • the above-mentioned occluder 100 is provided with a distal marking structure 51 and a first marking structure 52, the distal marking structure 51 is arranged on the distal head 20, and the first marking structure 52 is arranged on the sealing film 40, which can avoid only realizing It assists in locating or marking the local position of the occluder 100, but cannot help to determine the overall, three-dimensional shape of the occluder 100 during transportation and after release.
  • the distal marking structure 51 is embedded in the distal head 20, and the first marking structure 52 is located inside the bag-like structure formed by the blocking film 40, which can avoid the distal marking structure 51 and the first marking
  • the structure 52 is in direct contact with the sheath 200, thereby avoiding the phenomenon that the distal marking structure 51 and the first marking structure 52 rub against or rub against the inner wall of the sheath 200, causing the distal marking structure 51 and the first marking structure 52 to fall off.
  • the occluder 100 further includes a proximal sealing film 60 and / or a central sealing film 70, which can further improve the sealing effect.
  • the thickness distribution of the sealing film 40, the proximal sealing film 60, and the central sealing film 70 is controlled in the range of 5 to 100 microns, and the sealing device 100 is stretched under the premise of ensuring the sealing effect
  • the radial size of is not too large and excessively increases the matching size of the sheath 200.
  • the thickness distribution of the sealing film 40, the proximal sealing film 60, and the middle sealing film 70 is 20-70 microns.
  • a second marking structure 53 is provided on the proximal sealing film 60 and / or a third marking structure 54 is provided on the central sealing film 70.
  • the marking structure is dispersed in Proximal head 20, occlusion membrane 40, proximal occlusion membrane 60, and central occlusion membrane 70 match the marking structure with the contour configuration of occluder 100, which is helpful for the surgeon to judge occluder 100 as a whole The location and shape of the release.
  • the first marking structure 52 when the first marking structure 52 is provided on the sealing film 40, the second marking structure 53 is provided on the proximal sealing film 60, and the third marking structure 54 is provided on the central sealing film 70,
  • the first marking structure 52 includes two first markers 522 provided on both ends of the same diameter on the blocking film 40, and the second marking structure 53 includes two second markers provided on both ends of the same diameter on the proximal blocking film 60 532.
  • the third marking structure 54 includes two third markings 542 disposed on both ends of the middle sealing film 70 with the same diameter.
  • the first marker 522, the second marker 532, and the third marker 542 are all round metal sheets with a thickness of 50-500 microns and a diameter of 100-600 microns.
  • connection between the two first markers 522 and the distal marking structure 51 on the distal head 20 is changed from a triangle to a straight line so that the surgeon can accurately judge the distal blocking unit 11 and
  • the relative position of the compartment 2 can accurately identify the overall shape of the occluder 100, which is beneficial to release the occluder 100 more accurately, and does not increase the radial size or total volume of the occluder 100 in the stretched state To ensure that the occluder 100 can be transported smoothly.
  • proximal occlusion membrane 60 and / or the central occlusion membrane 70 may be omitted, and only the provision of the occlusion membrane 40 in the distal occlusion unit 11 can obtain the effect of blocking blood flow.
  • the occluder 100 when the occluder 100 further includes the proximal occluder membrane 60 and / or the middle flow blocking film 70, the second marking structure 53 and / or the middle occluder on the proximal occluder film 60
  • the third marking structure 54 on the flow film 70 may be omitted.
  • the cooperation of the distal marking structure 51 and the first marking structure 52 can also achieve accurate positioning of the occluder 100.
  • the sealing film 40 is fixed to the first distal disc surface 111 of the distal sealing unit 11 through the first suture 211 and the second suture 212, and through the third suture 213 and the fourth suture 214 fixes the proximal sealing film 60 to the second distal disc surface 121 of the proximal sealing unit 12, and fixes the central sealing film 70 to the waist 13 through the fifth suture 215 and the sixth suture so that In the stretched state, the centers of the sealing film 40, the proximal sealing film 60, and the central sealing film 70 all extend toward the distal head 20, and the edges of the three shrink to form a bag-like structure, respectively, so that It is better to avoid the first marking structure 52 on the occlusion membrane 40, the second marking structure 53 on the proximal occlusion membrane 60, and the third marking structure 54 on the middle occlusion membrane 70 from scratching with the inner wall of the sheath 200 .
  • first suture 211, the second suture 212, the third suture 213, the fourth suture 214, the fifth suture 215, and / or the sixth suture 216 may be omitted by an adhesive
  • the above-mentioned effects can also be achieved by adhering the sealing film 40, the proximal sealing film 60, and the middle sealing film 70 to corresponding positions.
  • the adhesive forms a first fixed node and a second fixed node on the blocking film 40, and the first fixed node and the second fixed node are used to connect the blocking film 40 and the first part of the remote blocking unit 11 A distal disk surface 111, and the second fixed node is farther from the outer peripheral surface of the sealing film 40 than the first fixed node, that is, the second fixed node is closer to the geometric center of the sealing film 40 than the first fixed node.
  • the adhesive forms a third fixed node and a fourth fixed node connecting the proximal blocking film 60 and the second distal disc surface 121 on the proximal blocking film 60, and the fourth fixed node is more than the third fixed node Far from the outer peripheral surface of the proximal sealing film 60, that is, the fourth fixed node is closer to the geometric center of the proximal sealing film 60 than the third fixed node.
  • the occluder 100 is an occluder that can be degraded by the living body and the degradation products can be absorbed by the living body
  • the occluded membrane 40, the proximal occluded membrane 60, and the central occluded membrane 70 are Made of absorbable materials.
  • the first suture 211, the second suture 212, the third suture 213, the fourth suture 214, the fifth suture 215, and the second six suture are all made of bioabsorbable materials.
  • the sealing film 40 and the proximal sealing film 60 are distributed and fixed on the distal sealing unit 11 and the proximal sealing unit 12 by an adhesive, the adhesive is a bioabsorbable occluder.
  • the sealing film 40 may be fixed on the first distal disc surface 112 of the distal sealing unit 11, and the first marking structure 52 is disposed on the sealing film 40 near the distal head 20 On the surface.
  • the proximal sealing film 60 can also be fixed on the second proximal disk surface 122 of the proximal sealing unit 12, and the third marking structure 53 is disposed on the surface of the proximal sealing film 60 near the distal head 20.
  • the first marking structure 52 is located inside the bag-like structure
  • the third marking structure 53 is also inside the bag-like structure. In this way, the phenomenon that the first marking structure 52 and the third marking structure 53 and the sheath tube are rubbed and rubbed can be avoided.
  • the occlusion membrane 40 when the occlusion membrane 40 is fixed to the first distal disc surface 112 of the distal occlusion unit 11, in the stretched state, the occlusion membrane 40 deforms and approaches the central occlusion membrane 70 in the waist 13 due to the waist 13
  • the size is small, no matter how the middle sealing 70 is deformed, it may cause the sealing membrane 40 and the middle sealing membrane 70 to overlap, the cross-sectional area of the overlap increases, which will increase the sheath of the occluder 100 Resistance or increase the size of the sheath.
  • the proximal sealing film 60 When the proximal sealing film 60 is fixed on the second proximal disk surface 122 of the proximal sealing unit 12, in the stretched state, the proximal sealing film 70 deforms and approaches the proximal sealing head 30, in the occluder
  • the proximal blocking film 70 blocks the opening of the proximal head 30, resulting in the locking member 50 failing to extend into the proximal head 30 smoothly In this way, the locking member 50 cannot lock the proximal blocking unit 11 and the distal blocking unit 12, resulting in the blocking device 100 being unable to be formed.
  • the distal occlusion unit 11 receives a pulling force directed in the direction of the distal head 20 At the same time, the first suture 211 and the second suture 212 (not shown in FIG.
  • the sealing film 40 of the above-mentioned occluder 100 is fixed to the first distal disc surface 111 of the distal sealing unit 11 so that, in the stretched state, the center of the sealing film 40 extends toward the distal head 20 And the edge of the sealing film 40 shrinks to form a bag-like structure, which can avoid the overlapping of the sealing film 40 and the central sealing film 70, thereby increasing the sheath insertion resistance of the occluder 100 or increasing the sheath tube specification.
  • the proximal sealing film 60 is fixed to the second distal disk surface 121 of the proximal sealing unit 12, so that in the stretched state, the proximal sealing film 60 is deformed and away from the distal sealing film 60, which is beneficial to avoid During the process of the occluder 100 changing from the stretched state to the natural state, the proximal blocking film 60 blocks the through hole of the proximal head 30 and the blocking device 100 cannot be formed, and at the same time, the curling phenomenon of the blocking film 40 can be avoided .
  • the sealing film 40 is fixed to the distal sealing unit by the first suture 211 and the second suture 212 (or the first fixed node and the second fixed node formed by an adhesive) 11 on the first distal disc surface 111, the third sealing suture 213 and the fourth suture 214 (or the third fixing node and the fourth fixing node formed by an adhesive) are used to fix the proximal sealing film 60 near
  • the middle sealing film 70 is fixed in the waist 13 by the fifth suture 215 and the sixth suture, so that in the stretched state, the sealing film 40, near
  • the centers of the end blocking film 60 and the middle blocking film 70 both extend toward the proximal head 20 as shown in FIG. 10.
  • controlling the positions of the first marking structure 52, the second marking structure 53 and the third marking structure 54 on the occlusion membrane 10, the proximal occlusion membrane 60 and the central occlusion membrane 70, respectively, not only during implantation Accurately position the occluder 100 and prevent the first marking structure 52, the second marking structure 53 and the third marking structure 54 from rubbing and scratching with the sheath 200, and can reduce the sheath insertion resistance of the occluder 100, while It is ensured that the occluder 100 is smoothly changed from the stretched state to the natural state (ie, the occluded state), so that the defective portion is occluded.

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Abstract

一种封堵器（100），包括支撑网（10）、远端封头（20）、近端封头（30）和封堵膜（40），远端封头（20）和近端封头（30）分别设置于支撑网（10）的两端，远端封头（20）上嵌设有远端标记结构（51），封堵膜（40）设置于支撑网（10）中，封堵膜（40）的表面上设置有第一标记结构（52），当将封堵器（100）处于拉伸状态时，封堵膜（40）的中心向靠近远端封头（20）或向靠近近端封头（30）的方向延伸，且封堵膜（40）的边缘收缩而形成袋状结构，第一标记结构（52）位于袋状结构的内部。该封堵器（100）避免标记结构脱落，且在X射线影像设备下，能够判断封堵器（100）整体的形态和封堵器（100）与缺损部位的准确的相对位置。

Description

封堵器 技术领域
本发明涉及医疗器械领域，特别是涉及一种封堵器。
背景技术
心脏缺损封堵器(以下简称封堵器)是一种治疗先天性心脏缺损的植入式医疗器械。封堵器的植入过程通常需要在DSA(Digital Subtraction Angiography，数字减影血管造影技术)等X射线影像设备的引导下进行手术操作，因此，要求封堵器有X射线下具有良好的可视性。
传统的封堵器通常由镍钛合金等金属制成，其在DSA设备下的可视性较好。而由高分子材料制成的封堵器在X光下的辐射不投性较差而导致可视性较差，在DSA下难以判断封堵器的准确位置和释放状态。因此，对于由高分子材料制成的封堵器，通常需要在封堵器上设置标记结构以辅助判断封堵器的准确位置和释放状态。现有的由高分子材料制成的封堵器，一般是将标记结构嵌设于封堵器的远端封头和/或近端封头中。标记结构被包裹于远端封头和/或近端封头的内部，在输送过程中，避免标记结构与鞘管的内壁发生摩擦、剐蹭而导致标记结构从远端封头和/或近端封头上脱落。
然而，标记结构嵌设于远端封头和/或近端封头上，在DSA设备下，仅能判断远端封头和/或近端封头的大概位置，难以判断封堵器整体的形态和封堵器与缺损部位的准确的相对位置关系。
发明内容
基于此，有必要提供一种能够避免标记结构脱落，且在X射线影像设备下，能够判断封堵器整体的形态和封堵器与缺损部位的准确的相对位置的封堵器。
一种封堵器，包括支撑网、远端封头和近端封头，所述远端封头和近端封头分别设置于所述支撑网的两端，所述远端封头上嵌设有远端标记结构，还包括设置于所述支撑网中的封堵膜，所述封堵膜的表面上设置有第一标记结构， 当将所述封堵器处于拉伸状态时，所述封堵膜的中心向靠近所述远端封头或向靠近所述近端封堵头的方向延伸，且所述封堵膜的边缘收缩而形成袋状结构，所述第一标记结构位于所述袋状结构的内部。
上述封堵器通过在远端封头上设置远端标记结构和在封堵膜中设置第一标记结构，远端标记结构和第一标记结构结合有利于判断封堵器整体的形态和封堵器与缺损部位的准确的相对位置。并且，在输送状态，远端标记结构嵌设于远端封头中，第一标记结构位于由封堵膜形成袋状结构的内部，能够避免远端标记结构和第一标记结构与鞘管直接接触，从而避免远端标记结构和第一标记结构与鞘管的内壁发生摩擦、剐蹭而导致远端标记结构和第一标记结构脱落的现象。
附图说明
图1为一实施方式的封堵器的结构示意图；
图2为图1所示的封堵器的第一远端盘面的结构示意图；
图3为图1所示的封堵器的封堵膜的结构示意图；
图4为图1所示的封堵器在鞘管中的示意图；
图5为图1所示的封堵器在拉伸状态下的结构示意图；
图6为图2的局部放大图；
图7为另一实施方式的封堵器的第一远端盘面的结构示意图；
图8为图7的局部放大图；
图9为一实施方式的第二缝线的走线示意图；
图10为一实施方式的封堵膜、近端封堵膜和中部封堵膜的固定方式示意图；
图11为图1所示的封堵器的封堵膜固定于第一近端盘面上的状态示意图；
图12a～图12d为一实施方式的封堵器的释放过程示意图；
图13a～图13d为一实施方式的封堵器的第一标记结构在封堵膜上的设置方式的示意图；
图14为图13b和图13c所示的实施方式的封堵器的释放状态示意图；
图15为一实施方式的封堵器的封堵膜的固定方式示意图。
具体实施方式
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。
请参阅图1，一实施方式的封堵器100，包括支撑网10、远端封头20、近端封头30和封堵膜40。远端封头20和近端封头30分别设置于支撑网10的两端。封堵膜40设置于支撑网10中。
本实施方式中，支撑网10包括远端封堵单元11、近端封堵单元12和腰部13，腰部13的两端分别连接远端封堵单元11和近端封堵单元12。远端封堵单元11和近端封堵单元12的宽度均大于腰部13的宽度，在自然状态(亦为封堵心脏缺损的状态)，支撑网10呈两端大中间小的结构，且远端封堵单元11和近端封堵单元12呈圆形，腰部13大致呈圆柱状。
具体地，远端封堵单元11包括第一远端盘面111、第一近端盘面112及连接第一远端盘面111和第一近端盘面112的第一脊部113。近端封堵单元12包括第二远端盘面121、第二近端盘面122及连接第二远端盘面121和第二近端盘面122的第二脊部123。
远端封头20设置于远端封堵单元11上，近端封头30设置于近端封堵单元12上，封堵膜40设置于远端封堵单元11中。远端封头20中设置有远端标记结构51。远端标记结构51用于在植入过程中标记远端封堵头20的位置。远端标记结构51的材料为在DSA等X射线影像设备下可视的材料。可以是在DSA等X射线影像设备下可视的金属材料或非金属材料。例如，远端标记结构51的材料为铂金、铂合金、黄金、钽、铁、钨、不锈钢、镍钛合金、钴铬合金、黄金 的合金、钨基合金及铁基合金中的至少一种。或者，远端标记结构51的材料也可以为溴化钠、碘化钠等非金属材料。
远端标记结构51的形状不限，能够满足远端标记结构51嵌设于远端封头20中的设置要求即可，如此设置，能够在满足可视性的要求的前提下，避免在输送过程中远端标记结构51脱落。
封堵器100还包括锁定件50。锁定件50设于支撑网10中，且锁定件50的一端与远端封头20固定连接，另一端与近端封头30可拆除连接。近端封头30上开设有通孔，当锁定件50穿过该通孔与近端封头30连接时，远端封堵单元11和近端封堵单元12之间的距离被固定。
本实施方式中，支撑网10为编织结构。支撑网10由多根高分子丝交叉编织形成，多根高分子丝交叉形成多圈交叉点。每圈交叉点均包括多个交叉点，同一圈交叉点的多个交叉点沿该圈的周向均匀分布(即相邻两个交叉点之间的距离均相等)，每一个交叉点均由两组旋向不同的编织丝交叉而成。支撑网10的高分子丝的远端自由端汇聚并固定于远端封头20中，高分子丝的近端自由端汇聚并固定于近端封头30中。
高分子丝的材料可以为聚乳酸(PLA)、聚乙醇酸(PGA)、聚羟基脂肪酸酯(PHA)、聚二氧环己酮(PDO)或聚己内醋(PCL)等可降解的材料。
在另外的实施方式中，支撑网10也可以由金属丝编织而成，例如，由镍钛合金丝编织而成。
支撑网10的远端封堵单元11、近端封堵单元12和腰部13均为网状结构。
如图2所示，第一远端盘面111的编织丝交叉形成多圈交叉点，多圈交叉点包括最外圈交叉点110(图2中最外圈虚线表示的圆周)以及距最外圈交叉点110最近的第一圈交叉点120(图2中最内圈虚线表示的圆周)。多圈交叉点还包括第二圈交叉点、第三圈交叉点等，第二圈交叉点位于第一圈交叉点内环，第三圈交叉点位于第二圈交叉点内环，以此类推。
第一近端盘面112、第二远端盘121和第二近端盘面122的编织方式与上述第一远端盘面111的编织方式相同，均包含最外圈交叉点，距最外圈交叉点最近的第一圈交叉点及第二圈交叉点、第三圈交叉点等，第二圈交叉点位于第一 圈交叉点内环，第三圈交叉点位于第二圈交叉点内环，以此类推，此处不再赘述。
请参阅图3，封堵膜40为圆形的片状结构，且封堵膜40的大小与远端封堵单元11的大小相适配，使得将封堵膜40设于远端封堵单元11中时，封堵膜40的外周面41与远端封堵单元11的第一脊部113的内表面抵接(如图1所示)，有利于提高封堵效果，避免封堵器100植入后发生残余分流。
封堵膜40固定于远端封堵单元11中。本实施方式中，封堵器100还包括第一缝线211和第二缝线212。封堵膜40通过第一缝线211和第二缝线212与远端封堵单元11固定相连，且第一缝线211比第二缝线212更靠近第一远端封堵单元11的边缘，即第一缝线211比第二缝线212更靠近封堵膜40的外周面41，使得将封堵器100以拉伸的状态装载于鞘管200中时(如图4所示)，封堵膜40的中心向靠近远端封头20的方向延伸，且封堵膜40的边缘收缩而形成袋状结构(如图4和图5所示)。
请一并参阅图2和图6，具体地，通过第一缝线211将封堵膜40的缝合于第一远端盘面111的最外圈交叉点110和第一圈交叉点120处，第一缝线211在封堵膜40上的缝合位置如图3中的圆周410和圆周420所示。圆周410和圆周420上的小圆圈表示具体的缝合点。第一缝线211与远端封堵单元11的多个交点2112分布于最外圈交叉点110和第一圈交叉点120上，即不在同一圆周上，不在同一截面上。
对于由高分子丝编织的封堵器100，由于高分子丝本身没有弹性或弹性较弱，导致封堵器100的回弹性较差，在外力的作用下容易使网格变得不均匀，不能回复到原定型的形状，封堵膜40容易移位变形，最终植入人体后会导致封堵膜40与心脏缺损部位的贴壁性较差，从而造成残余分流。上述外力的作用来源于将封堵器100收进鞘管200过程中鞘管口对第一缝线211与远端封堵单元11的交点2112的推挤作用，导致网格跟着交点2112一起发生位移变形，封堵膜40的边缘也会发生移位变形、卷边等现象。
将第一缝线211与远端封堵单元11的多个交点2112错开，使第一缝线211与远端封堵单元11的多个交点2112不在同一圆周上。如此，能够分散封堵器 100进鞘过程中鞘管口对交点2112的作用力，将作用力分散在不同的截面上，从而能够减小进鞘时鞘管口对第一缝线211和封堵膜40的阻力及挤推作用，同时由于同一截面交点2112的数量减少，大大减少了鞘管口对第一缝线211作用点数量，降低了封堵器100收进鞘管200时由于鞘管口推挤交点2112而使第一缝线211和封堵膜40的交点向封堵器100的远端发生位移的可能，进而可以有效地降低封堵膜40卷边现象发生的可能。
需要说明的是，本实施方式中，第一缝线21为连续的缝线，在其他实施方式中，第一缝线21可以为不连续的缝线。当第一缝线21为不连续的缝线时，第一缝线211与远端封堵单元11形成多个分散的交点2112，任意两个交点2112间没有任何连接。如此，第一缝线211与远端封堵单元11的多个交点2112可以位于同一圆周上，也可以分布于不同的圆周上。即便第一缝线211与远端封堵单元11的多个交点2112可以位于同一圆周上，也能够降低封堵膜40卷边现象发生的可能。
本实施方式中，最外圈交叉点110上的多个第一缝线211的交点2112等间距分布。第二圈交叉点120上的多个第一缝线211的交点2112等间距分布。
在另一实施方式中，最外圈交叉点110上的多个第一缝线211的交点2112可以是非等间距分布的。此时，第二圈交叉点120上的多个第一缝线211的交点2112可以等间距分布，也可以非等间距分布。
本实施方式中，最外圈交叉点110上，编织丝的所有交叉点均为第一缝线211与第一远端盘面111的交点2112，即最外圈交叉点110上，编织丝的所有交叉点均被第一缝线211所缠绕。第二圈交叉点110上，编织丝的所有交叉点均为第二缝线212与第一远端盘面111的交点2112，即第一圈交叉点120上，编织丝的所有交叉点均被第一缝线211所缠绕。缝合时，以第一缝线211为例，首先勾住选择的最外圈交叉点110的某一处交叉点，然后走线到第二圈交叉点120相邻的交叉点处将其勾住，再走到最外圈交叉点110相邻的交叉点将其勾住，再走到第二圈交叉点120相邻交叉点将其勾住，如此交替勾住两圈交叉节点，重复以上动作，沿圆周走针一周后两线头打结。
在另一方式中，缝合方式也可以隔一个或隔几个交叉点缝合，而不是每个 交叉点都与第一缝线211或第二缝线222相交。请一并参阅图7和图8，第一缝线211的缝合方式为第一缝线211在最外圈交叉点110上隔一个交叉点缝合，第一缝线211在第二圈交叉点120上亦隔一个交叉点缝合。缝合时，首先用第一缝线211勾住选择的最外圈交叉点110的某一处交叉点，然后走线到第二圈交叉点120的交叉点处将其勾住，接着上下各跳开一格交叉点，然后将线走到最外圈交叉点110的交叉点勾住，再走到第二圈交叉点120相邻的交叉点勾住，如此重复以上动作，沿圆周走针一周后两线头打结。这种缝合方式中，最外圈交叉点110上交点2112和第一交叉点110上的交点2112的数量均减少，在满足封堵膜40固定于远端封堵单元11中的前提下，可以减小封堵器100进鞘时鞘管口对交点2112的作用力，因为同一个圆周截面上的交点2112越少，其作用力越小，封堵膜40位移变形的可能性会更低。
第二缝线212可以与远端封堵单元11仅形成一个交叉点(如图5所示)，也可以与远端封堵单元11形成多个交叉点，见图9。第二缝线212可以是连续的缝线，且与远端封堵单元11形成多个交叉点，如图9和图10所示。该实施方式中，第二缝线212与远端封堵单元11的交叉点不在同一圆周上，而是分布于两个圆周上，并且第二缝线212与远端封堵单元11的交点均比第一缝线211与远端封堵单元11的交点更靠近封堵膜40的几何中心。在另外的实施方式中，第二缝线212是不连续的缝线，第二缝线212与远端封堵单元11形成多个分散的交叉点，任意两个交叉点间没有任何连接。
第二缝线212比第一缝线211更靠近封堵膜40的几何中心，按上述方式同时设置第二缝线212和第一缝线211，能够保证封堵器100在拉伸状态时，封堵膜40的中心向靠近远端封头20的方向延伸，且封堵膜40的边缘收缩而形成袋状结构。当第二缝线212为连续的缝线或与第二缝线212与远端封堵单元11形成多个交叉点时，有利于提高封堵膜40收缩成上述袋状结构的可靠性。进一步地，当第二缝线212与远端封堵单元11的交叉点不在同一圆周上，而是分布于两个圆周上，封堵膜40收缩成上述袋状结构的可靠性更高。
请再次参阅图1，封堵膜40通过第一缝线211和第二缝线212与远端封堵单元11的第一远端盘面111固定相连，且封堵膜40与远端封堵单元11的第一 近端盘面112不固定相连。封堵膜40与远端封堵单元11的第一近端盘面112仅处于物理接触的状态。
请再次参阅图3，第一缝线211在封堵膜40上的缝合点分别于圆周410和圆周420上，其中圆周410与封堵膜40的外周面41的距离(与封堵膜40的外边缘的距离)为1～2毫米，以保证第一缝线211与封堵膜40可靠缝合而不会产生第一缝线211从封堵膜40的边缘脱落的同时，避免封堵膜40出现卷边现象。
封堵膜40的中部开设有远端通孔42，远端通孔42的孔径与锁定件50的大小相适配，以使锁定件50的近端能够穿过该远端通孔42而与近端封头30可拆卸连接。本实施方式中，远端通孔42为圆形孔。远端通孔42的孔径为0.5～1毫米，以保证锁定件50能够通过的同时，避免开孔过大而影响封堵膜40的封堵效果。可以理解，在其他实施方式中，远端通孔42的不限于为圆形孔，可以为其他形状的通孔，例如，方形孔、条形孔、十字缝隙等等。
请再次参阅图1，封堵器100还包括第一标记结构52。第一标记结构52设置于封堵膜40上，并且第一标记结构52设置于封堵膜40的靠近近端封头30的表面上。请参阅图5，本实施方式中，第一标记结构52包括两个间隔设置第一标记物522。在自然状态下，两个第一标记物522与远端标记结构51的连线呈三角形。
以房间隔缺损封堵术为例，当远端封堵单元11在左心房LA展开了，通过调整X射线影像设备的角度，远端标记结构51和两个第一标记物522之间可以形成一个三角形，如图12a所示。在X光的引导下，术者牵拉封堵器100向近端移动使之靠近房间隔2位置。当继续牵拉封堵器100向近端移动至远端封堵单元11的第一近端盘面112与房间隔2有部分抵接时，两个第一标记物522与远端标记结构51的连线仍然呈三角形，如图12b所示。此时如果继续牵拉封堵器100，由于两个第一标记物522紧挨着房间隔2，运动受限，而远端封头20的运动不受限，在此情况下，远端标记结构51和两个第一标记物522构成的三角形的形状将发生变化，如图12c所示，直至三点成一线。如果此时继续牵拉封堵器100，则远端封头20有可能越过房间隔缺损位置，容易造成封堵器100脱落，如图12d所示。因此，设置远端标记结构51和包括两个第一标记物522 的第一标记结构52，并在自然状态下，使两个第一标记物522与远端标记结构51的连线呈三角形，当操作过程中，该三角形变化成直线时即表示封堵器100与房间隔2的贴壁良好，可以停止牵拉操作而继续释放封堵器100的近端封堵单元12。设置远端标记结构51和包括两个第一标记物522的第一标记结构52，并在自然状态下，使两个第一标记物522与远端标记结构51的连线呈三角形，有利于准确定位封堵器100，获得较好的封堵效果。并且，能够避免封堵器100因定位不准确而脱落，提高了临床应用的安全性。
在一实施方式中，请参阅图13a，两个第一标记物522均位于封堵膜40的边缘，且两个第一标记物522的连线的长度与封堵膜40的直径相等，即两个第一标记物522处于封堵膜40的同一直径的两端。如此设置，更利于准确定位封堵器100，以提高封堵效果和提高临床应用的安全性。无论封堵膜40为何种形状，两个第一标记物522位于封堵膜40的沿径向方向的距离的最大的两个点上，且两个第一标记物522的连线穿过封堵膜40的几何中心，以有利于准确判断封堵器100与缺损部位贴壁。可以理解，在其他实施方式中，当封堵膜40的形状不是圆形，而是其他形状时，仍然将两个第一标记物522位于封堵膜40的沿径向方向的距离的最大的两个点上。例如，当封堵膜40为椭圆形时，两个第一标记物522位于椭圆形的封堵膜40的长轴的两端。
在一实施方式中，第一标记物522为圆形的金属片。例如，可以为圆形的黄金片、铂金片、不锈钢片等等。进一步地，该金属片的厚度为50～500微米，直径为100～600微米，以保证封堵器100在DSA等X射线影像设备下的可视性，且该金属片不至于过大而影响封堵器100的输送。
通过贴合粘接的方式将第一标记结构52固定在封堵膜40的靠近近端封头20的表面上。如此，加工较为简单，制备效率高。
在其他实施方式中，第一标记物522的数量不限于两个，可以更多。例如，第一标记物522的数量为2～12范围内的偶数。在一实施方式中，参阅图13b，多个第一标记物522间隔设置，且多个第一标记物522位于封堵膜40的同一直径上，距离最大的两个第一标记物522位于该直径的两端。由于鞘管200为圆柱形管，没有方向性，导致在手术过程中，当封堵器100的远端封堵单元11释 放后，按上述方式在封堵膜40的同一直径上设置多个第一标记物522，能够保证沿图5中VI-VI线的剖面上，封堵器100的两个距离最大的第一标记物522的连线即两个第一标记物522所在的直径与锁定件50垂直，从而使得该两个距离最大的第一标记物522与远端标记结构51的连线呈三角形。如此，手术操作较为简单，有利于减少调整DSA等X射线影像设备的角度的操作，能够较快地定位封堵器100。
在另一实施方式中，多个第一标记物522呈圆周分布，如图13c所示。第一标记物522的数量为大于2的偶数，且数量大于2的偶数个第一标记物522两两成对地设置于封堵膜40上，每对第一标记物522的连线穿过封堵膜40的几何中心。由于鞘管200为圆柱形管，没有方向性，导致在手术过程中，当封堵器100的远端封堵单元11释放后，按上述方式设置两两对称设置多个第一标记物522，能够保证沿图5中VI-VI线的剖面上，封堵器100的两个第一标记物522的连线即两个第一标记物522所在的直径与锁定件50垂直，从而使得该两个距离最大的第一标记物522与远端标记结构51的连线呈三角形。如此，亦能减少调整DSA等X射线影像设备的角度的操作，能够较快地定位封堵器100。
可以理解，在其他实施方式中，第一标记物522的数量也可以为奇数个，只要保证至少有两个第一标记物522与远端标记结构51的连线呈三角形。
在另一实施方式中，第一标记结构52也可以呈环状，如图13d所示。例如，第一标记结构52为环状的金属片，该环状的金属片的外环直径与封堵膜40等径，或者该环状的金属片的外环直径小于封堵膜40的直径，且该环状的金属片的外边缘靠近封堵膜40的外边缘设置或该环状的金属片的外边缘与封堵膜40的外边缘重合。如此，亦能够保证在自然状态下，在沿图5中VI-VI线的剖面上，封堵器100的第一标记结构52的距离最大的两个点的连线即与锁定件50垂直，从而使得该环状的金属片的两端与远端标记结构51的连线呈三角形。
请参阅图14，当多个第一标记物522位于封堵膜40的同一直径上，距离最大的两个第一标记物522位于该直径的两端或多个第一标记物522呈圆周分布时，远端标记结构51和多个第一标记物522之间可以形成一个三角形，有利于封堵器100的准确释放。
上述封堵器100通过在远端封头20上设置远端标记结构51和在封堵膜40中设置第一标记结构52，远端标记结构51和第一标记结构52结合有利于判断封堵器100整体的形态和封堵器100与缺损部位的准确的相对位置。并且，在输送状态，远端标记结构51嵌设于远端封头20中，第一标记结构52位于由封堵膜40形成袋状结构的内部，能够避免远端标记结构51和第一标记结构52与鞘管200直接接触，从而避免远端标记结构51和第一标记结构52与鞘管200的内壁发生摩擦、剐蹭而导致远端标记结构51和第一标记结构52脱落的现象。
需要说明的是，本实施方式中的，封堵器100的支撑网10为两盘一腰的结构，在其他实施方式中，支撑网10可以为其他结构，例如为截面呈T字型的结构，包括封堵盘和与封堵盘连接的腰部，此时封堵膜40设置于封堵盘中。
请再次参阅图1，封堵器100还包括近端封堵膜60，以进一步提高封堵效果，避免发生残余分流的现象。近端封堵膜60设置于近端封堵单元12中。近端封堵膜60亦为圆形的片状结构，且近端封堵膜60的大小与近端封堵单元12的大小相适配，使得将近端封堵膜60设于近端封堵单元12中时，近端封堵膜60的外周面与近端封堵单元12的第二脊部123的内表面抵接，有利于提高封堵效果，避免封堵器100植入后发生残余分流。
近端封堵膜60固定于近端封堵单元12中。本实施方式中，封堵器100还包括第三缝线213和第四缝线214。近端封堵膜60通过第三缝线213和第四缝线214与近端封堵单元12固定相连，且第三缝线213比第四缝线214更靠近近端封堵膜60的外周面，使得将封堵器100以拉伸的状态装载于鞘管200中时，近端封堵膜60的中心向靠近远端封头20的方向延伸，且近端封堵膜60的边缘收缩而形成袋状结构，如图5所示。
近端封堵膜60在近端封堵单元12中的固定方式与封堵膜40在远端封堵单元11中的固定方式大致相同。
具体地，通过第三缝线213将近端封堵膜60缝合于第二远端盘面121的最外圈交叉点和第一圈交叉点处。第三缝线213与近端封堵单元12的交点分布于最外圈交叉点和第一圈交叉点，即不在同一圆周上，不在同一截面上。
将第三缝线213与近端封堵单元12的多个交点错开，使第三缝线213与近 端封堵单元12的多个交点不在同一圆周上。如此，能够分散封堵器100进鞘过程中鞘管口对交点的作用力，将作用力分散在不同的截面上，从而能够减小进鞘时鞘管口对第三缝线213和近端封堵膜60的阻力及挤推作用，同时由于同一截面交点的数量减少，大大减少了鞘管口对第三缝线213作用点数量，降低了封堵器100收进鞘管200时由于鞘管口推挤交点而使第三缝线213和近端封堵膜60的交点向封堵器100的远端发生位移的可能，进而可以有效地降低近端封堵膜60卷边现象发生的可能。
第四缝线214可以与近端封堵单元12仅形成一个交点，也可以与近端封堵单元12形成多个交点。第四缝线214可以是连续的缝线，且与近端封堵单元12形成多个交点。该实施方式中，第四缝线214与近端封堵单元12的交点不在同一圆周上，而是分布于两个圆周上。在另外的实施方式中，第四缝线214是不连续的缝线，第四缝线214与近端封堵单元12形成一个多个分散的交点，任意两个交点间没有任何连接。
请再次参阅图1，近端封堵膜60通过第三缝线213和第四缝线214与近端封堵单元12的第二远端盘面121固定连接，且近端封堵膜60与近端封堵单元12的第二近端盘面122不固定连接，两者仅为物理接触。如此，能够避免当将封堵器100进行轴向拉伸时，近端封堵膜60的边缘上翻转形成两层卷边的现象。
第三缝线213在近端封堵膜60上的缝合点在同一圆周上，该圆周与近端封堵膜60的外周面的距离为1～2毫米，以保证第三缝线213与近端封堵膜60可靠缝合而不会产生第三缝线213从近端封堵膜60的边缘脱落的同时，避免近端封堵膜60出现卷边现象。
第三缝线213、第四缝线214、近端封堵膜60和第二远端盘面121的固定方式及走线方式可以按上文所述的第一缝线211、第二缝线212、封堵膜40和第一远端盘面111的固定方式及走线方式设置。但需要说明的是，在同一个封堵器100上，第三缝线213、第四缝线214、近端封堵膜60和第二远端盘面121的固定方式及走线方式和第一缝线211、第二缝线212、封堵膜40和第一远端盘面111的固定方式及走线方式可以相同，也可以不同。例如，第一远端盘面111的最外圈交叉点110上，编织丝的所有交叉点均被第一缝线211所缠绕，而 第二远端盘面121的最外圈交叉点上，可以是编织丝的所有交叉点均被第三缝线213所缠绕，也可以是仅有编织丝的部分交叉点被第三缝线213所缠绕。
在一实施方式中，近端封堵膜60的中部开始有近端通孔以供锁定件50穿过。近端通孔的形状不限，可以与远端通孔42的形状相同，也可以不同。近端通孔的尺寸的孔径为0.5～1毫米。
在一实施方式中，封堵器100还包括第二标记结构53。第二标记结构53设于近端封堵膜60的靠近近端封头30的表面上，使得在拉伸状态，第二标记结构53位于由近端封堵膜60形成袋状结构内部。
第二标记结构53的结构与第一标记结构52的结构相同，通过贴合粘接的方式将第二标记结构53固定在近端封堵膜60的靠近近端封头20的表面上。
在一实施方式中，请参阅图5，第二标记结构53包括多个第二标记物532。第二标记物532为厚度50～500微米，直径100～600微米的圆形金属片。第二标记结构53包括2～12范围内的偶数个第二标记物532，多个第二标记物532沿圆周间隔设置，且偶数个第二标记物532两两成对地设置于近端封堵膜60上，每对第二标记物532的连线穿过近端封堵膜60的几何中心。或者，多个第二标记物532间隔地设置于近端封堵膜60的同一直径上，且距离最大的两个第二标记物532位于该直径的两端。本实施方式中，第二标记物532的数量为两个，两个第二标记物532处于近端封堵膜60的同一直径的两端，且两个第二标记物532的连线穿过近端封堵膜60的几何中心。
可以理解，在其他实施方式中，第二标记物532的数量也可以为奇数个，只要保证至少有两个第二标记物532与远端标记结构51的连线呈三角形。
在另一实施方式中，第二标记结构53呈环状。例如，第二标记结构53为环状的金属片。此时，第二标记结构53的大小及第二标记结构53在近端封堵膜60上的设置位置与第一标记结构52大小及第一标记结构52在封堵膜40上设置位置相同，在此不再赘述。
请再次参阅图1，在一实施方式中，封堵器100还包括中部封堵膜70，以进一步提高封堵效果，避免发生残余分流。中部封堵膜70设置于腰部13中。中部封堵膜70亦为圆形的片状结构，且中部封堵膜70的大小与腰部13的大小 相适配，使得将中部封堵膜70设于腰部13中时，中部封堵膜70的外周面与腰部13的内表面抵接，有利于提高封堵效果，避免封堵器100植入后发生残余分流。
请参阅图10，本实施方式中，封堵器100还包括第五缝线215和第六缝线(图10未示)。中部封堵膜70通过第五缝线215和第六缝线与腰部13固定相连，且第五缝线215比第六缝线更靠近远端封头20，使得将封堵器100以拉伸的状态装载于鞘管200中时，中部封堵膜70的中心向靠近远端封头20的方向延伸，且中部封堵膜70的边缘收缩而形成袋状结构。
中部封堵膜70在腰部13中的固定方式与封堵膜40在远端封堵单元11中的固定方式大致相同。
具体地，通过第五缝线215将中部封堵膜70的缝合于腰部13中部的相邻的两圈交叉点处。第五缝线215与腰部13的交点不在同一圆周上，不在同一截面上。
将第五缝线215与腰部13的多个交点错开，使第五缝线215与腰部13的多个交点不在同一圆周上。如此，能够分散封堵器100进鞘过程中鞘管口对缝线交点的作用力，将作用力分散在不同的截面上，从而能够减小进鞘时鞘管口对第五缝线215和中部封堵膜70的阻力及挤推作用，同时由于同一截面交点的数量减少，大大减少了鞘管口对第五缝线215作用点数量，降低了封堵器100收进鞘管时由于鞘管口推挤交点而使第五缝线215和中部封堵膜70的交点向封堵器100的远端发生位移的可能，进而可以有效地降低中部封堵膜70卷边现象发生的可能。
需要说明的是，在另外的实施方式中，第五缝线215与腰部13的交点可以位于同一圆周上。由于腰部13的直径相对较小，中部封堵膜70的大小也相对较小，当将封堵器100拉伸进鞘时，相对于远端封堵单元11和近端封堵单元12而言，腰部13进鞘管200时不会产生较大的进鞘力。另外，因腰部13大致为圆柱状，中部封堵膜70难以与腰部13严格地贴合，相对远端封堵单元11和近端封堵单元12而言，不会容易产生网格变形而导致中部封堵膜70移位或卷边。
第六缝线可以与腰部13仅形成一个交点，也可以与腰部13形成多个交点。 第六缝线可以是连续的缝线，且与腰部13形成多个交点。该实施方式中，第六缝线与腰部13的交点不在同一圆周上，而是分布于两个圆周上。在另外的实施方式中，第六缝线是不连续的缝线，第六缝线216与腰部13形成多个分散的交点，任意两个交点间没有任何连接。
在一实施方式中，中部封堵膜70的中部开设有中部通孔，以供锁定件50穿过。中部通孔的形状不限，可以与通孔42的形状相同，也可以不同。中部通孔的尺寸的孔径为0.5～1毫米。锁定件50依次穿过远端通孔42、中部通孔和近端通孔而与近端封头30可拆除连接。
在一实施方式中，封堵器100还包括第三标记结构54。第三标记结构54设于中部封堵膜70的靠近近端封头30的表面上，使得在拉伸状态，第三标记结构54位于由中部封堵膜70形成袋状结构内部。
第三标记结构54的结构与第一标记结构52的结构相同，通过贴合粘接的方式将第三标记结构54固定在中部封堵膜70的靠近近端封头30的表面上。
请一并参阅图1和图5，在一实施方式中，第三标记结构54包括多个第三标记物542。第三标记物542为厚度50～500微米，直径100～600微米的圆形金属片。在一实施方式中，第三标记结构54包括2～12范围内的偶数个第三标记物542,多个第三标记物542沿圆周间隔设置，且偶数个第三标记物542两两成对地设置于中部封堵膜70上，每对第三标记物542的连线穿过中部封堵膜70的几何中心。或者，多个第三标记物542间隔地设置于中部封堵膜70的同一直径上，且距离最大的两个第三标记物542位于该直径的两端。本实施方式中，第三标记物542的数量为两个，两个第三标记物542处于中部封堵膜70的同一直径的两端，两个第三标记物542的连线穿过中部封堵膜70的几何中心。
可以理解，在其他实施方式中，第三标记物542的数量也可以为奇数个，只要保证至少有两个第三标记物542与远端标记结构51的连线呈三角形。
在另一实施方式中，第三标记结构54呈环状。例如，第三标记结构54为环状的金属片。此时，第三标记结构54的大小及第三标记结构54在中部封堵膜70上的设置位置与第一标记结构52大小及第一标记结构52在封堵膜40上设置位置相同，在此不再赘述。
在一实施方式中，封堵器100还包括近端标记结构55，近端标记结构55嵌设于近端封头30中。近端封头30与输送缆300可拆卸连接，在植入过程中，近端封头30与输送缆300固定相连(如图4所示)。植入后，且封堵器100完全释放并与缺损部位贴壁后，近端封头30与输送缆300分离。设置近端标记结构55，能够辅助识别封堵器100的整体形态，且有利于判断封堵器100是否与输送缆300顺利分离，以保障植入手术顺利进行。并且，当发生极端情况时，同时设置远端标记结构51和近端标记结构55，有利于封堵器100的回收。
进一步地，近端标记结构55可以嵌设于近端封头30的壁上，也可以嵌设于近端封头30的的内腔中。当近端标记结构55嵌设于近端封头30的的内腔中时，近端标记结构55呈环状，以便于锁定件50穿过近端封头30。
上述封堵器100通过设置远端标记结构51和第一标记结构52，远端标记结构51设置在远端封头20上，第一标记结构52设置在封堵膜40上，能够避免仅实现辅助定位或标识封堵器100的局部位置，而无法帮助判断封堵器100在输送过程中和释放后的整体的、立体的形态。并且，在输送状态，远端标记结构51嵌设于远端封头20中，第一标记结构52位于由封堵膜40形成袋状结构的内部，能够避免远端标记结构51和第一标记结构52与鞘管200直接接触，从而避免远端标记结构51和第一标记结构52与鞘管200的内壁发生摩擦、剐蹭而导致远端标记结构51和第一标记结构52脱落的现象。进一步地，封堵器100还包括近端封堵膜60和/或中部封堵膜70，能够进一步提高封堵效果。并且，封堵膜40、近端封堵膜60和中部封堵膜70的厚度分布控制在5～100微米范围内，在保证封堵效果的前提下，使封堵器100在拉伸状态下的径向尺寸不至于过大而过分增大鞘管200的匹配尺寸。在一实施方式中，封堵膜40、近端封堵膜60和中部封堵膜70的厚度分布为20～70微米。
进一步地，近端封堵膜60上设有第二标记结构53和/或中部封堵膜70上设有第三标记结构54，相对于仅在局部设置标记结构的方式，将标记结构分散于近端封头20、封堵膜40、近端封堵膜60和中部封堵膜70上，使标记结构与封堵器100的轮廓构型相匹配，有利于术者整体判断封堵器100的释放位置和形态。进一步地，当封堵膜40上设有第一标记结构52的同时，近端封堵膜60上 设有第二标记结构53，且中部封堵膜70上设有第三标记结构54时，第一标记结构52包括两个设于封堵膜40上同一直径两端的第一标记物522，第二标记结构53包括两个设于近端封堵膜60上同一直径两端的第二标记物532，第三标记结构54包括两个设于中部封堵膜70上同一直径两端的第三标记物542。第一标记物522、第二标记物532和第三标记物542均为厚度为50～500微米，直径为100～600微米的圆形的金属片。上述设置方式，在保证两个第一标记物522与远端封头20上的远端标记结构51的连线从三角形到一字形的变化以使术者能够准确判断远端封堵单元11与房间隔2相对位置的同时，能够准确地识别封堵器100的整体形态，有利于更准确地释放封堵器100，并且不增加在拉伸状态的封堵器100的径向尺寸或总体积，从而保证能够顺利地输送封堵器100。
可以理解，在其他实施方式中，近端封堵膜60和/或中部封堵膜70可以省略，仅在远端封堵单元11中设置封堵膜40亦可获得阻断血流的效果。
可以理解，在其他实施方式中，当封堵器100还包括近端封堵膜60和/或中部阻流膜70时，近端封堵膜60上的第二标记结构53和/或中部阻流膜70上的第三标记结构54可以省略。通过远端标记结构51和第一标记结构52配合亦可实现封堵器100的准确定位。
需要说明的是，通过第一缝线211和第二缝线212将封堵膜40固定于远端封堵单元11的第一远端盘面111上，通过第三缝线213和第四缝线214将近端封堵膜60固定于近端封堵单元12的第二远端盘面121上，通过第五缝线215和第六缝线将中部封堵膜70固定于腰部13上，使得在拉伸状态，封堵膜40、近端封堵膜60和中部封堵膜70的中心均向靠近远端封头20的方向延伸，且三者的边缘收缩而分别形成袋状结构，从而能够较好地避免封堵膜40上的第一标记结构52、近端封堵膜60上的第二标记结构53和中部封堵膜70上的第三标记结构54与鞘管200的内壁发生剐蹭。在其他实施方式中，第一缝线211、第二缝线212、第三缝线213、第四缝线214、第五缝线215和/或第六缝线216可以省略，通过粘接剂将封堵膜40、近端封堵膜60和中部封堵膜70粘接于相应的位置，亦可实现上述效果。
具体地，粘接剂在封堵膜40上形成第一固定节点和第二固定节点，第一固 定节点和第二固定节点用于连接所述封堵膜40和远端封堵单元11的第一远端盘面111，且第二固定节点较第一固定节点更远离封堵膜40的外周面，即第二固定节点较第一固定节点更靠近封堵膜40的几何中心。粘接剂在近端封堵膜60上形成连接所述近端封堵膜60和第二远端盘面121的第三固定节点和第四固定节点，且第四固定节点较第三固定节点更远离近端封堵膜60的外周面，即第四固定节点较第三固定节点更靠近近端封堵膜60的几何中心。如此，亦能使封堵器100在轴向拉伸的状态下，封堵膜40和近端封堵膜60的中心均向靠近远端封头20的方向延伸，且二者的边缘收缩而分别形成袋状结构。
需要说明的是，当封堵器100为在生物体能够降解且降解产物能够被生物体所吸收的封堵器时，封堵膜40、近端封堵膜60和中部封堵膜70由生物可吸收的材料制成。相应地，第一缝线211、第二缝线212、第三缝线213、第四缝线214、第五缝线215和第二六缝线均由生物可吸收的材料制成。当封堵膜40和近端封堵膜60通过粘接剂分布固定于远端封堵单元11和近端封堵单元12上时，粘接剂为生物可吸收的封堵器。
可以理解，在其他实施方式中，封堵膜40可以固定于远端封堵单元11的第一远端盘面112上，第一标记结构52设置于封堵膜40的靠近远端封头20的表面上。近端封堵膜60亦可固定于近端封堵单元12的第二近端盘面上122，第三标记结构53设置于近端封堵膜60的靠近远端封头20的表面上。在拉伸状态，封堵膜40和近端封堵膜60变形形成袋状结构时，第一标记结构52位于袋状结构的内部，第三标记结构53亦位于袋状结构的内部。如此，亦能避免第一标记结构52和第三标记结构53与鞘管发生摩擦、剐蹭等现象。
然而，当封堵膜40固定于远端封堵单元11的第一远端盘面112上时，在拉伸状态，封堵膜40变形而靠近腰部13中的中部封堵膜70，由于腰部13的尺寸较小，此时无论中部封堵70如何变形，都有可能会导致封堵膜40和中部封堵膜70重叠，重叠处的截面积增大，这会增加封堵器100的入鞘阻力或加大鞘管规格。当近端封堵膜60固定于近端封堵单元12的第二近端盘面上122上时，在拉伸状态，近端封堵膜70变形而靠近近端封头30，在封堵器100由拉伸状态变成自然状态的过程中，扣紧锁定件50的时候，近端封堵膜70堵住近端封头 30的开口，导致锁定件50无法顺利伸入近端封头30中，以至锁定件50无法锁紧近端封堵单元11和远端封堵单元12，导致封堵器100无法成型。
并且，如图15所示，当封堵膜40固定于第一近端盘面112上，将封堵器100拉伸入鞘时，远端封堵单元11受到指向远端封头20方向的拉力，同时第一缝线211和第二缝线212(图15未示)会拉扯封堵膜40而阻止封堵膜40向靠近远端封头20的方向延伸变形，导致封堵膜40的缝合位置处难以向靠近远端封头20的方向延伸，因此会出现两层卷边的现象，两层卷边现象导致拉伸后的封堵器100的截面积增大，从而增大鞘管200的配合尺寸，最终增加了在输送过程中对血管的损伤风险。并且，当鞘管200的配合尺寸的增大至一定程度时，有可能导致不能适应于血管较小的患者。
上述封堵器100的封堵膜40固定于远端封堵单元11的第一远端盘面111上，使得在拉伸状态时，封堵膜40的中心向靠近远端封头20的方向延伸，且封堵膜40的边缘收缩而形成袋状结构，能够避免封堵膜40和中部封堵膜70重叠，而增加封堵器100的入鞘阻力或加大鞘管规格的现象。近端封堵膜60固定于近端封堵单元12的第二远端盘面上121，使得在拉伸状态，近端封堵膜60变形而远离远端封堵膜60，有利于避免在封堵器100由拉伸状态变成自然状态的过程中，近端封堵膜60阻塞近端封头30的通孔而导致封堵器100无法成型，同时能够避免封堵膜40出现卷边现象。因此，在一实施方式中，通过第一缝线211和第二缝线212(或通过粘接剂形成的第一固定节点和第二固定节点)将封堵膜40固定于远端封堵单元11的第一远端盘面111上，通过第三缝线213和第四缝线214(或通过粘接剂形成的第三固定节点和第四固定节点)将近端封堵膜60固定于近端封堵单元12的第二远端盘面上121上，通过第五缝线215和第六缝线将中部封堵膜70固定于腰部13中，使得在拉伸状态，封堵膜40、近端封堵膜60和中部封堵膜70的中心均向靠近近端封头20的方向延伸，如图10所示。并且，分别控制第一标记结构52、第二标记结构53和第三标记结构54在封堵膜10、近端封堵膜60和中部封堵膜70上的位置，不仅在植入手术中能够准确定位封堵器100及避免第一标记结构52、第二标记结构53和第三标记结构54与鞘管200发生摩擦、剐蹭等现象，并且，能够降低封堵器100的入鞘阻力， 同时保障封堵器100由拉伸状态顺利地变成自然状态(即封堵状态)，从而实现缺损部位的封堵。
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 (18)

  1. 一种封堵器，包括支撑网、远端封头和近端封头，所述远端封头和近端封头分别设置于所述支撑网的两端，所述远端封头上嵌设有远端标记结构，其特征在于，还包括设置于所述支撑网中的封堵膜，所述封堵膜的表面上设置有第一标记结构，当将所述封堵器处于拉伸状态时，所述封堵膜的中心向靠近所述远端封头或向靠近所述近端封堵头的方向延伸，且所述封堵膜的边缘收缩而形成袋状结构，所述第一标记结构位于所述袋状结构的内部。
  2. 根据权利要求1所述的封堵器，其特征在于，所述第一标记结构包括至少两个第一标记物，在所述封堵器的自然状态下，至少两个所述第一标记物与所述远端标记结构的连线呈三角形。
  3. 根据权利要求1所述的封堵器，其特征在于，所述支撑网包括远端封堵单元、近端封堵单元和腰部，所述腰部的两端分别连接所述远端封堵单元和所述近端封堵单元，所述远端封头设置于所述远端封堵单元上，所述近端封头设置于所述近端封堵单元上，所述封堵膜设置于所述远端封堵单元中。
  4. 根据权利要求3所述的封堵器，其特征在于，所述封堵器还包括设于所述支撑网内的锁定件，所述锁定件的一端与所述远端封头固定相连，另一端与所述近端封头可拆卸连接。
  5. 根据权利要求1～4任一项所述的封堵器，其特征在于，所述远端封堵单元包括第一远端盘面、第一近端盘面及连接所述第一远端盘面和所述第一近端盘面的第一脊部，所述封堵膜设置于所述远端封堵单元中，
    所述封堵器还包括第一缝线和第二缝线，所述封堵膜与所述远端封堵单元通过所述第一缝线和第二缝线固定相连，所述第一缝线和所述第二缝线间隔设置，且所述第二缝线较所述第一缝线更远离所述封堵膜的外周面；或者，
    所述封堵膜与所述远端封堵单元通过粘接剂固定相连，所述粘接剂在所述封堵膜上形成第一固定节点和第二固定节点，所述第一固定节点和第二固定节点用于连接所述所述封堵膜和所述远端封堵单元，且所述第二固定节点较所述第一固定节点更远离所述封堵膜的外周面。
  6. 根据权利要求5所述的封堵器，其特征在于，所述第一标记结构设置于所述封堵膜的靠近所述近端封头的表面上；
    所述封堵膜与所述远端封堵单元的第一远端盘面通过所述第一缝线和第二缝线固定相连，所述封堵膜与所述远端封堵单元的第一近端盘面不固定相连；或者，
    所述封堵膜与所述远端封堵单元的第一远端盘面通过所述第一固定节点和第二固定节点相连，所述封堵膜与所述远端封堵单元的第一近端盘面不固定相连。
  7. 根据权利要求5所述的封堵器，其特征在于，所述第一缝线与所述远端封堵单元的交点不在同一圆周上。
  8. 根据权利要求4所述的封堵器，其特征在于，所述近端封堵单元包括第二远端盘面、第二近端盘面及连接所述第二远端盘面和所述第二近端盘面的第二脊部，所述封堵膜还包括近端封堵膜，所述近端封堵膜设置于所述近端封堵单元中，且所述近端封堵膜的外周面与所述第二脊部的内表面抵接。
  9. 根据权利要求8所述的封堵器，其特征在于，所述封堵器还包括第三缝线和第四缝线，所述近端封堵膜通过所述第三缝线和第四缝线固定于所述近端封堵单元的第二远端盘面上，且所述第四缝线较所述第三缝线更远离所述近端封堵膜的外周面；或者
    所述近端封堵膜与所述近端封堵单元的第二远端盘面通过粘接剂固定相连，所述粘接剂在所述近端封堵膜上形成连接所述所述近端封堵膜和所述第二远端盘面的第三固定节点和第四固定节点，且所述第四固定节点较所述第三固定节点更远离所述近端封堵膜的外周面。
  10. 根据权利要求9所述的封堵器，其特征在于，所述第三缝线与所述第二远端盘面的交点不在同一圆周上。
  11. 根据权利要求8所述的封堵器，其特征在于，所述封堵器还包括第二标记结构，所述第二标记结构设置于所述近端封堵膜的表面上。
  12. 根据权利要求11所述的封堵器，其特征在于，所述第二标记结构包括至少两个第二标记物，在所述封堵器的自然状态下，至少两个所述第二标记物与所述远端标记结构的连线呈三角形。
  13. 根据权利要求10所述的封堵器，其特征在于，所述封堵器还包括中部 封堵膜，所述中部封堵膜设于所述腰部中，且所述中部封堵膜的外周面与所述腰部的内壁抵接。
  14. 根据权利要求13所述的封堵器，其特征在于，所述封堵器还包括第五缝线，所述中部封堵膜与所述腰部通过第所述五缝线固定连接，且所述第五缝线与所述腰部的交叉点不在同一截面上。
  15. 根据权利要求14所述的封堵器，其特征在于，所述封堵器还包括第六缝线，所述第六缝线将所述中部封堵膜与所述腰部固定相连，且所述第六缝线较所述第五缝线更靠近所述远端封头。
  16. 根据权利要求14所述的封堵器，其特征在于，所述封堵器还包括第三标记结构，在所述封堵器的自然状态下，所述第三标记结构设置于所述中部封堵膜的表面上。
  17. 根据权利要求16所述的封堵器，其特征在于，所述第三标记结构包括至少两个第三标记物，在所述封堵器的自然状态下，至少两个所述第三标记物与所述远端标记结构的连线呈三角形。
  18. 根据权利要求13所述的封堵器，其特征在于，所述封堵膜上开设有远端通孔，所述中部封堵膜上开设有中部通孔，所述近端封堵膜上开设有近端通孔，所述锁定件依次穿过所述远端通孔、中部通孔和近端通孔而与所述近端封头可拆卸连接。
PCT/CN2019/114704 2018-11-08 2019-10-31 封堵器 WO2020093926A1 (zh)

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Publication number Priority date Publication date Assignee Title
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Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070118176A1 (en) * 2005-10-24 2007-05-24 Opolski Steven W Radiopaque bioabsorbable occluder
CN201591648U (zh) * 2009-10-30 2010-09-29 上海锦葵医疗器械有限公司 可降解可显影房间隔缺损闭合器
US20130274791A1 (en) * 2007-07-13 2013-10-17 Percutaneous Systems, Inc. Apparatus for occluding body lumens
CN205251616U (zh) * 2015-11-27 2016-05-25 先健科技(深圳)有限公司 可吸收封堵器
CN105764426A (zh) * 2013-10-10 2016-07-13 卡拉格股份公司 封堵器
CN206995285U (zh) * 2016-01-05 2018-02-13 上海锦葵医疗器械有限公司 可显影可降解的心脏室间隔缺损封堵器
CN108261214A (zh) * 2016-12-31 2018-07-10 先健科技(深圳)有限公司 封堵器及封堵器的缝合方法
CN108729026A (zh) * 2018-08-16 2018-11-02 哈尔滨工业大学 一种基于静电纺丝制备心脏封堵器阻流膜的方法及应用
CN109464168A (zh) * 2018-12-17 2019-03-15 先健科技(深圳)有限公司 封堵器
CN109700487A (zh) * 2018-12-29 2019-05-03 先健科技(深圳)有限公司 输送器和输送系统
CN109770964A (zh) * 2018-12-11 2019-05-21 先健科技(深圳)有限公司 封堵器及其制备方法
CN209611205U (zh) * 2018-11-08 2019-11-12 先健科技(深圳)有限公司 封堵器
CN209611204U (zh) * 2018-11-08 2019-11-12 先健科技(深圳)有限公司 封堵器

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070118176A1 (en) * 2005-10-24 2007-05-24 Opolski Steven W Radiopaque bioabsorbable occluder
US20130274791A1 (en) * 2007-07-13 2013-10-17 Percutaneous Systems, Inc. Apparatus for occluding body lumens
CN201591648U (zh) * 2009-10-30 2010-09-29 上海锦葵医疗器械有限公司 可降解可显影房间隔缺损闭合器
CN105764426A (zh) * 2013-10-10 2016-07-13 卡拉格股份公司 封堵器
CN205251616U (zh) * 2015-11-27 2016-05-25 先健科技(深圳)有限公司 可吸收封堵器
CN206995285U (zh) * 2016-01-05 2018-02-13 上海锦葵医疗器械有限公司 可显影可降解的心脏室间隔缺损封堵器
CN108261214A (zh) * 2016-12-31 2018-07-10 先健科技(深圳)有限公司 封堵器及封堵器的缝合方法
CN108729026A (zh) * 2018-08-16 2018-11-02 哈尔滨工业大学 一种基于静电纺丝制备心脏封堵器阻流膜的方法及应用
CN209611205U (zh) * 2018-11-08 2019-11-12 先健科技(深圳)有限公司 封堵器
CN209611204U (zh) * 2018-11-08 2019-11-12 先健科技(深圳)有限公司 封堵器
CN109770964A (zh) * 2018-12-11 2019-05-21 先健科技(深圳)有限公司 封堵器及其制备方法
CN109464168A (zh) * 2018-12-17 2019-03-15 先健科技(深圳)有限公司 封堵器
CN109700487A (zh) * 2018-12-29 2019-05-03 先健科技(深圳)有限公司 输送器和输送系统

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