WO2018145535A1 - 封堵器 - Google Patents

封堵器 Download PDF

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Publication number
WO2018145535A1
WO2018145535A1 PCT/CN2017/119963 CN2017119963W WO2018145535A1 WO 2018145535 A1 WO2018145535 A1 WO 2018145535A1 CN 2017119963 W CN2017119963 W CN 2017119963W WO 2018145535 A1 WO2018145535 A1 WO 2018145535A1
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WO
WIPO (PCT)
Prior art keywords
rods
occluder
plugging
connecting portion
plugging surface
Prior art date
Application number
PCT/CN2017/119963
Other languages
English (en)
French (fr)
Inventor
李彪
葛均波
周达新
叶金华
沈雳
Original Assignee
宁波迪创医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by 宁波迪创医疗科技有限公司 filed Critical 宁波迪创医疗科技有限公司
Publication of WO2018145535A1 publication Critical patent/WO2018145535A1/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
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00796—Breast surgery

Definitions

  • the present invention relates to the field of transcutaneous medical devices, and more particularly to a method for transmitting to a human body and/or an animal by means of an interventional method by a sheath delivery technique for sealing a defect opening, or a tissue break, inside An occluder for cavities, organ passages, and the like.
  • Interventional therapy is an emerging treatment between surgical and medical treatment, including endovascular intervention and non-vascular interventional therapy. After more than 30 years of development, it has been called the three pillar disciplines together with surgery and internal medicine. To put it simply, interventional therapy is a microchannel with a diameter of a few millimeters on the blood vessels and skin, or through the original pipeline of the human body, in an imaging device (angiography machine, fluoroscopy machine, CT, MR). , B-ultrasound, etc., the treatment of the lesions under the guidance of the minimally invasive treatment. Interventional therapy has the advantages of small trauma, simple, safe, effective, less complications and significantly shorter hospital stay.
  • the occluder can be used to block a defect opening in a human body and/or an animal, or a tissue breach, a lumen, an organ passage.
  • congenital heart disease which has been widely used clinically, including atrial septal defect (as shown in Figure 1), ventricular septal defect, patent ductus arteriosus and other defect openings
  • the main principle is The "holes" in the left and right heart chambers, the “holes” between the left and right ventricles, and the passage between the aorta and the pulmonary artery are blocked.
  • the occluder is delivered to the defect opening of the human body and/or the animal body, or the path through which the tissue breach, the internal cavity, and the organ passage pass, including the human arteriovenous and/or the heart, is too distorted, requires
  • the sheath has a very small outer diameter and is flexible, and the occluder is required to easily enter the sheath and be easily released from the sheath, so the occluder should have a low profile performance after compression.
  • the occluder should be able to accurately reach the intended site and completely effectively block the defect opening, lumen, and organ passage. This requires the occluder to have good mechanical requirements and blood flow requirements.
  • the structure of the occluder must have Very reasonable design.
  • the basic structure of the occluder is a self-expanding double disc or mushroom-like structure in which a superelastic nickel-titanium alloy wire is alternately interspersed up and down to form a stent body, and the main body of the stent body is filled.
  • membranes made of polyester or polytetrafluoroethylene to block the flow of blood into or out of the defect opening, or tissue breaks, lumens, and organ passages.
  • atrial septal defect type occluder, left atrial appendage occluder, its position in the cardiac anatomy is shown in Figures 2 and 3. It has the advantage of simple structure, but has many shortcomings, including
  • the occluder adopts the traditional upper and lower alternate interweaving woven structure, resulting in:
  • the compression length of the occluder closure disk after being compressed into the sheath tube is far greater than the length of the natural state after it is released from the sheath tube, and the reversible deformation of the membrane is limited, so the film cannot be used (film and silk in all areas) All fixed connection) design;
  • the relative position between the membrane and the filament of the closure disc is not fixed.
  • the membrane is disorderly disordered in the sheath, resulting in a large gap, thus sealing
  • the profile is larger, resulting in a larger sheath diameter.
  • the left atrial appendage occluder the smallest sheath currently adaptable is 8-10F; this still has high requirements for blood vessels and vascular access. , that is, the current occluder has certain adaptation limitations;
  • the film used is basically a non-woven fabric of polyester or polytetrafluoroethylene
  • the non-woven fabric is biocompatible and soft, but not suitable for suturing, which easily causes the film to be detached from the occluder. Or the membrane is torn, so that it cannot be effectively blocked. It has been verified through previous experiments and uses;
  • the membrane is inside the occlusion disc, and the nickel-titanium alloy wire that seals the disc will directly contact with the blood, which leads to the risk of nickel ions being precipitated, which eventually leads to toxicity, sensitization and teratogenicity, and the biocompatibility is not good; It is easy to cause complications such as thrombosis on the surface of the sealing disc.
  • the purpose of the present application is to solve the problem that the prior art adopts the traditional upper and lower alternate interpenetrating woven structure and can not realize the film initiation, and provides an easy filming, complete sealing, smaller body shape after compression and better anatomical adaptability.
  • the occluder is to solve the problem that the prior art adopts the traditional upper and lower alternate interpenetrating woven structure and can not realize the film initiation, and provides an easy filming, complete sealing, smaller body shape after compression and better anatomical adaptability.
  • the occluder is to solve the problem that the prior art adopts the traditional upper and lower alternate interpenetrating woven structure and can not realize the film initiation, and provides an easy filming, complete sealing, smaller body shape after compression and better anatomical adaptability.
  • An occluder comprising at least one occlusion disk; the occlusion disk comprising a central end portion, a first sealing surface, a second sealing surface and a connecting portion, wherein the first sealing portion
  • the surface is composed of a plurality of main rods that are directly diverged from the central end portion toward the edge of the sealing surface, and the second sealing surface is connected to the first sealing surface through the connecting portion, and the connecting portion is Composed of a plurality of sub-bars separated from each of the main rods, a plurality of the sub-rods are cross-woven to form a grid-like structure, and a curved section is disposed on the sub-rods, and the grid-like structure is The intersection of the plurality of sub-rods adjacent to the first plugging surface is the first intersection, and the first plugging surface is coated.
  • the curved section is disposed between a connection point of the connecting portion and the first blocking surface and a first intersection.
  • the curved section is disposed between the first intersection and a connection point of the second plugging surface and the connecting portion.
  • the occluder located on one side of the first plugging surface is coated with the first intersection as a boundary point.
  • the first plugging surface is coated within the membrane.
  • the main rod of the first plugging surface is inserted and fixed on the membrane.
  • the plurality of sub-rods of the connecting portion extend away from the first plugging surface, form a grid-like structure by cross-weaving, and converge toward the connecting center member to form the second plugging surface. .
  • a center of the second plugging surface is provided with a connecting center piece, and the second plugging surface is a plurality of main rods directly diverging from the connecting center piece toward the edge of the second plugging surface It is configured that each of the main rods is divided into a plurality of sub-rods at the edges, and is correspondingly connected with the sub-rods of the connecting portion.
  • the second plugging surface is coated with a film.
  • a fixed connection structure is provided between adjacent main rods.
  • each of the main rods is composed of a plurality of rods, a plurality of the rods are joined together by a fixing member, or a plurality of the rods are entangled with each other.
  • each of the main rods is provided with a wire hole through which a plurality of the main rods are connected in series.
  • the sub-rods located at the intersection of the grid-like structures are fixedly connected.
  • each of the main rods is composed of a plurality of rods, and a part of the plurality of rods are cross-woven to form a joint portion of a grid-like structure at a joint of the joint portion and the first plugging surface.
  • a curved section is disposed on the rod; another portion of the plurality of rods continues to extend, and a plurality of the rods that are separated from the adjacent main rod and continue to extend toward the circumferential edge are respectively connected to form the The extension of the first blockage.
  • the first blocking surface is a flat surface, or a concave curved surface in the middle, or an edge of the first sealing surface is curved toward the second sealing surface.
  • the bending section is disposed at an angle such that the first sealing surface is in contact with the connecting portion and the second sealing surface in a free state.
  • the bending section is disposed at an angle such that the connecting portion is cylindrical in a free state, or a truncated cone shape, or a top hat shape.
  • the sealing surface is made of a material such as nickel-titanium alloy, cobalt-chromium alloy, stainless steel, titanium, tantalum, platinum, rhodium, tungsten, gold, magnesium, zinc and alloys thereof, or polyamide or polyether.
  • a material such as nickel-titanium alloy, cobalt-chromium alloy, stainless steel, titanium, tantalum, platinum, rhodium, tungsten, gold, magnesium, zinc and alloys thereof, or polyamide or polyether.
  • Polymer materials such as block amide, polyimide, polyurethane, polyketone, and polyolefin.
  • the film is made of polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, silicone, polyurethane, polyamide, silica gel, polyolefin, or degradable materials such as polylactic acid and polyvinyl alcohol.
  • the membrane is selected from animal tissues.
  • the central end is detachably connected to the push rod.
  • the first plugging surface structure formed by the plurality of main rods disposed in the occluder of the present application directly diverging from the central end portion toward the edge of the plugging surface, so that the first plugging of the plugging disc of the occluder
  • the compression length after the surface is compressed into the delivery sheath is equal to the length of the natural state after it is released from the delivery sheath, so that the film is finally realized on the first sealing surface, and the coating is prevented from being realized in the prior art. Placing a film inside the occluder woven mesh provides a series of problems caused by the connection of the film to the stent body by simple stitching.
  • the position between the main rods on the first sealing surface is basically unrestricted, and the movement is relatively independent, which not only facilitates the producer to easily carry out series production operations such as lamination, but also makes the production convenient; and can also adapt to the uneven opening of the defect
  • the shape of the wall of the region avoids the formation of a void region between the sealing disk of the conventional occluder and the partition wall of the defect opening region, greatly improving the anatomical adaptability of the sealing disk and enhancing the sealing effect.
  • the first sealing surface is coated in the film, or the main rod of the first sealing surface is inserted on the membrane, which has many advantages: the relative relationship between the plurality of main rods and the membrane in the first sealing surface The position is fixed, and after the first plugging surface is compressed into the conveying sheath, the membrane is arranged in the sheath to form a tight packing, which reduces the compressed shape of the sealing surface, reduces the minimum diameter of the conveying sheath used, and reduces
  • the requirements for the surgical approach are to expand the scope of application of the occluder; after the occluder is placed at the target position, the biocompatible film is directly or completely in contact with a large area such as blood, which greatly reduces the traditional occluder.
  • the direct contact of the nickel-titanium alloy wire with blood causes nickel ions to precipitate, eventually leading to toxicity, sensitization and teratogenicity, and the risk of thrombosis on the surface of the occluder.
  • the first plugging surface is completely coated in the membrane. This risk can be avoided even; the friction coefficient of the film of the polymer material is lower than that of the metal material such as nickel-titanium alloy, and the frictional resistance is reduced during the release or recovery of the occluder from the delivery sheath, so that the operator feels more good.
  • the first plugging surface of the occluder of the present application may be provided with a fixed connection structure such that after the occluder is recovered, or released, and released to the target position, all the main poles of the first plugging surface are at the center
  • the central axis of the end is kept rotationally symmetric.
  • the membrane is further arranged in the sheath to be further closely packed, thereby further reducing the first
  • the compressed shape of the sealing surface minimizes the diameter of the delivery sheath used, further reduces the requirement for the surgical approach, expands the scope of application of the occluder, and also improves the roundness of the occluder.
  • the first plugging surface of the occluder of the present application may be a flat surface, or a concave curved surface of the center, or a curved surface of an arbitrary shape such as an edge of the first plugging surface bent toward the second plugging surface, the connecting portion In the free state, it may be a flat surface, or a truncated cone shape, or a cylindrical shape, or a top hat shape, or any other shape of the curved surface, and the connecting portion may be selectively provided with upper and lower cross knitting, or a structure that is entangled with each other, and may be adjusted.
  • the occluder adapts to the anatomical shape of the target position to the best, further enhancing the sealing effect.
  • the first plugging surface of the occluder of the present application can also be provided with an extension portion to enlarge the sealing area of the first plugging surface, thereby further enhancing the sealing effect.
  • Figure 1 is a schematic view showing the position of the atrial septal defect and the left atrial appendage in the cardiac anatomy
  • FIG. 2 is a schematic view showing the shape of a prior art atrial septal defect occluder in the heart
  • FIG. 3 is a schematic view showing the shape of a prior art left atrial appendage occluder in the heart
  • FIG. 4A-4B are structural views of a plugging surface (including a connecting portion) of a prior art occluder, wherein FIG. 4A is a left side view of FIG. 4B; FIG. 4B is a side view of the plugging disc;
  • FIG. 5A-5B are schematic views showing the structure of the first embodiment of the occluder of the present application, wherein FIG. 5A is a left side view of FIG. 5B, and FIG. 5B is a cross-sectional view along an axial center of the center end;
  • FIG. 6A-6C are structural views of the first plugging surface of the first embodiment of the occluder of the present application, wherein FIG. 6A is a left side view of FIG. 6B, and FIG. 6B is a center axis along the center end.
  • Figure 6C is a cross-sectional view taken along line AA of Figure 6B;
  • Figure 7 is a schematic view showing the structure of the first plugging surface of the second embodiment of the occluder of the present application.
  • FIG. 8A-8C are schematic structural views of a third embodiment of the occluder of the present application, wherein FIG. 8A is a left side view of FIG. 8b, which shows only the first plugging surface structure and a part of the connecting portion which are not covered by the film. (Bending section) structure, FIG. 8C is a cross-sectional view taken along line AA of FIG. 8b, which only shows the structure of the second plugging surface and the structure of a part of the connecting portion;
  • FIGS. 9A-9E are schematic structural views of a fourth embodiment of the occluder of the present application, wherein FIGS. 9A, 9B are both left side views of FIG. 9C, and the view only shows the first plugging surface structure and part not covered by the film.
  • FIG. 9D is a right side view of FIG. 9C, which shows only the structure of the second plugging surface structure and the partial connecting portion (bending section) which are not covered, and
  • FIG. 9E is the drawing of FIG. 9C. a cross-sectional view of the center of the center end after the film is covered by the plugging surface and the second plugging surface;
  • Figure 10 is a cross-sectional view of the fifth embodiment of the occluder of the present application after only the first plugging surface is coated and along the axis of the central end.
  • 1 is the occluder
  • 3 is the defect opening
  • 4 is the left atrium
  • 5 is the right atrium
  • 6 is the void area
  • 7 is the inner cavity
  • 10 is the sealing disk
  • 11 is the anchoring frame
  • 40 is the opening area of the left atrial appendage
  • the left atrium inner wall 41 is the left atrial appendage
  • 42 is the left atrial appendage
  • 50 is the atrial septum at the defect opening area
  • 100 is the central end
  • 101 is the first sealing surface
  • 101' is the second sealing surface
  • 102 is a film
  • 103 is a connecting portion
  • 104 is an extending portion
  • 105 is a connecting center member
  • 1001 is a connecting nut
  • 1010 is a main rod of a first plugging surface
  • 1010' is a main rod of a second plugging surface
  • 1011 is Rod
  • 1012 is a fixing member
  • 1013 is a series line
  • 1014 is a wire hole
  • Embodiment 1 is a diagrammatic representation of Embodiment 1:
  • the occluder of the first embodiment of the present application can be used for occlusion of a defect opening such as an atrial septal defect, a ventricular septal defect, and a tissue break such as a blood vessel.
  • the occluder includes two occlusion discs 10, each of which includes a central end portion 100, a first occluding surface 101, and a second occlusion portion.
  • the face 101' and the connecting portion 103, the two plug disks 10 are connected by a connecting center piece 105 coaxial with the central axis of the center end portion 100.
  • the first plugging surface 101 and the second plugging surface 101' of the plugging disc 10 are respectively a plurality of main rods 1010 and main rods 1010 which are directly diverged from the center end portion 100 and the connecting center member 105 toward the edge of the plugging disc. 'Constituent.
  • the second plugging surface 101' is connected to the first plugging surface 101 by the connecting portion 103, and the connecting portion 103 is composed of a plurality of sub-rods 1031 separated from each of the main rods 1010, and a plurality of The sub-rods 1031 are cross-woven to form a grid-like structure, and the sub-rod 1031 is provided with a curved section 1032, and the plurality of the adjacent ones of the grid-like structures adjacent to the first plugging surface 101
  • the intersection of the sub-rods 1031 is the first intersection 1033, and the first plugging surface 101 is coated.
  • the plurality of main rods 1010 and the main rods 1010' are directly diverged from the central end portion 100 and the joint center member 105 toward the edge of the plugging surface to form a first plugging surface 101 and a second plugging surface 101'.
  • This design has many advantages: 1.
  • the compression length of the first sealing surface 101 of the sealing disk 10 after being compressed into the delivery sheath is just equal to the length of its natural state after being released from the delivery sheath, thereby ultimately making the entire It is possible to cover the film on a plugging surface 101, avoiding the inability to realize the filming in the prior art, and having to place the film inside the occluder woven mesh, and then connecting the film to the stent body by simple stitching. a series of problems caused; 2.
  • the position between the main rods 1010 on the first plugging surface 101 and the main rod 1010' on the second plugging surface 101' is substantially unrestricted, and the movement is relatively independent, which not only makes
  • the first blocking surface 101 and the second sealing surface 101' are adapted to the shape of the partition wall of the uneven opening area, and the gap area 6 is formed between the sealing disk of the conventional occluder and the partition wall 50 of the defect opening area. (as shown in Figure 2), greatly The anatomical adaptability of the plug disk 10 is increased, the plugging effect is enhanced, and the producer can easily perform a series of film production processes, including placing a soft space between the main rods 1010 or between the main rods 1010'. The film enters the inside of the plugging disk 10, spreads the film inside thereof, and finally sutures or otherwise connects the film inside the main rod to the main rod 1011, thereby making the production convenient.
  • each of the main rods 1010 or the main rods 1010' is composed of two rods 1011 or 1011', and is woven together by knitting or the like to form a mutually entangled woven structure, intertwined woven fabric.
  • the structure is such that the relative position between each of the main rods 1010 or the two rods 1011 or 1011' of the main rod 1010' is fixed.
  • the second plugging surface 101' is connected to the first plugging surface 101 via the connecting portion 103.
  • the connecting portion 103 is composed of two sub-rods 1031 separated from each of the main rods 1010, and the plurality of sub-rods 1031 of the connecting portion 103 and the first seal
  • the plurality of rods 1011 of the plugging surface 101 are correspondingly connected and connected one by one, and each of the main rods 1010' of the second plugging surface 101' is divided into two sub-rods 1031' at the circumferential edge of the sealing surface 101', and is connected to the connecting portion
  • the other ends of the sub-rods 1031 of 103 are respectively connected to each other, and the plurality of sub-rods 1031 of the connecting portion 103 are cross-woven to form a lattice structure.
  • the design advantages of the cross-knitted mesh structure are as follows: 1.
  • the first sealing surface 101 of the sealing disk 10 When the first sealing surface 101 of the sealing disk 10 is compressed into or released from the conveying sheath, the first sealing surface 101 is always coaxial
  • the second plugging surface 101' thereby avoiding the unevenness of the supporting force between the respective sub-rods 1031 of the connecting portion 103, causes the two plugging surfaces 101 and 101' of the plugging disc 10 to form a chamfer and thereby increase the resistance to the sheathing tube. And avoiding the occurrence of poor positioning when the occluder is released, morphologically poor after release, resulting in incomplete occlusion, etc.; 2.
  • the occluding disc 10 is more adaptive to the deeper defect opening or tissue rupture, so that the first sealing surface 101 and the second sealing surface 101 ′ are attached to the defect opening or the tissue rupture area, as shown in FIG. 2 .
  • the partition wall 50 at the defect opening area is shown to enhance the sealing effect; of course, the bending function can make the first sealing surface 101 and the second sealing surface 101' different axes, thus adapting to different shafts of the defect opening or tissue breaking mouth.
  • a curved section 1032 is disposed on the sub-rod 1031 of the connecting portion 103.
  • the curved section 1032 may be disposed between the connection point of the connecting portion 103 and the first sealing surface 101 and the first intersection 1033, or may be disposed at the first intersection.
  • the side of the point 1033 adjacent to the second plugging surface 101' ie, between the first intersection 1033 and the junction point of the second plugging surface 101' and the connecting portion 103), wherein the first intersection 1033 is It is defined as the intersection of the plurality of sub-rods 1031 adjacent to the first plugging surface 101 in the mesh-like structure of the connecting portion 103.
  • the curved portion 1032 may be provided over the entire connecting portion.
  • the curved section 1032 is designed such that the first sealing surface 101 of the sealing disc 10 is compressed into the delivery sheath or released from the delivery sheath smoothly and smoothly, avoiding the operator's large operational resistance during the whole process and making the operation feel
  • the first sealing surface 101 can be brought into contact with the connecting portion 103 and the second sealing surface 101' in the free state.
  • the thickness between the first plugging surface 101 and the second plugging surface 101' is reduced, so that the first plugging surface 101 and the second plugging surface 101' are more closely attached to the partition wall of the defect opening area after the occluder is released. To further enhance the sealing effect.
  • the main rod 1010, 1010', or the rod 1011, or the sub-rods 1031, 1031' of the plug disk 10 is made of a shape memory material selected from the group consisting of nickel-titanium (NiTi) alloy, cobalt chromium (CoCr) alloy, etc.
  • Metal materials with shape memory function, or other metal materials such as stainless steel, titanium, tantalum, platinum, tungsten, gold, magnesium, zinc and their alloys, or polyamide, polyether block amide, polyimide, polyurethane, polyketone , polymer materials such as polyolefin. As shown in FIG.
  • the tamping disk 10 can be combined with a plurality of nickel-titanium alloy wires as the rods 1011 by means of preliminary heat treatment to form a mutually entangled woven structure, so that the relative pairs of the rods 1011 are opposed.
  • the plurality of main rods 1010 are fixed in position and form the first plugging surface 101, and then the plurality of rods 1011 continue to extend in the circumferential direction of the plugging surface 101, and the mesh structure of the connecting portion 103 is formed by cross knitting, followed by a grid shape.
  • Each pair of intersecting rods in the structure are combined by preliminary heat treatment in a manner of two-to-one intertwined weaving to form a mutually entangled woven structure, so that the relative positions of the pairs of rods are fixed and the plurality of mains of the second plugging surface 101' are formed.
  • the rod 1010' is finally subjected to heat treatment to shape the joint portion 103 and the plugging surface into a desired shape by a final setting die.
  • Both sides of the plugging surface 101 of the first embodiment are covered with a membrane 102 which functions to prevent blood from flowing into or out of the defect opening and to break the tissue such as a blood vessel.
  • Suitable materials for the membrane 102 of the first plugging surface 101 of the plugging disc 10 include polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, silicone, polyurethane elastomer, polyamide, silica gel, polyolefin, and Degradable materials such as polylactic acid, polyvinyl alcohol, and animal tissues.
  • the membrane 102 completely encloses the main rod 1010 or the rod 1011 in the first plugging surface 101, as shown in Fig. 6B. This design has many advantages: 1.
  • the relative position of the 1010 or the plurality of rods 1011 and the membrane 102 is fixed.
  • the membranes are arranged in the sheath to achieve close packing, instead of the membrane of the conventional occluder.
  • the chaotic disorder leads to a large gap, thus reducing the compressed body shape of the first sealing surface 101 of the occluder disk 10, reducing the diameter of the delivery sheath used, reducing the requirement for the surgical approach, and enlarging the seal
  • the membrane is in direct contact with the blood, etc., avoiding the nickel-titanium alloy wire and blood of the occluder Direct contact causes nickel ion precipitation to eventually lead to toxicity, sensitization and teratogenicity, and the occurrence of thrombus on the surface of the occluder; 3.
  • the coefficient of friction of the polymer material film is lower than that of metal materials such as nickel-titanium alloy During the release or recovery of the occluder from the delivery sheath Frictional resistance is reduced, so that the operator operation feel better.
  • connection portion 103 located on the side of the boundary point close to the first plugging surface 101 should also be covered, as shown in FIGS. 6A-6C, which causes the edge of the film 102 to be first.
  • the sealing surface 101 is firmly fixed, and there is substantially no connection between the membrane of the polymer material and the first sealing surface 101 of the metal material such as Nitinol, and the membrane is discharged during the release process of the occluder after repeated recovery.
  • the film 102 on both sides of the first plugging surface 101 can be fused by heat sintering, hot melting, or the like to form a film.
  • ePTFE expanded polytetrafluoroethylene
  • Bonding can also be achieved by means of a bonding agent between the film and the film, including but not limited to polyurethane (TPU) solution, fluorinated ethylene propylene copolymer (FEP) emulsion, glue loctite 3011, 3321, 3493 , 3494, 3751, 4011, 4013, EA M-31CL; glue Dymax203a-cth-f, 204-cth-f, 1201-m-sc, 1128a-m; glue NuSil MED-2000P; glue Dow Corning SILASTIC MEDICAL ADHESIVE SILICONE , TYPE A.
  • TPU polyurethane
  • FEP fluorinated ethylene propylene copolymer
  • the first plugging surface 101 can be covered with a polyurethane (TPU) or the like by dip coating or spraying, and finally the film can be completed.
  • sutures can also be used to suture the film and the film together.
  • the suture can be non-absorbable sutures such as polypropylene, polyamide, polyester, ultra-high molecular weight polyethylene, polytetrafluoroethylene, etc. Tissue, polylactic acid, polyglycolic acid, etc. absorbable sutures.
  • the central end portion 100 can be provided with a coupling nut 1001 having an internal threaded structure.
  • the coupling nut 1001 is detachably coupled to a push rod in the delivery system, and the push rod is rotated to release the occluder at the defect opening of the target.
  • Other structures such as snaps may be provided on the center end portion 100 to achieve a detachable connection with the push rod.
  • Embodiment 2 is a diagrammatic representation of Embodiment 1:
  • the second embodiment is different from the first embodiment in that the first plugging surface 101 of any of the plugging discs 10 constitutes a main pole.
  • the plurality of rods 1011 of 1010 are substantially parallel to each other, and the main rod 1010 is inserted through the membrane 102.
  • This design allows the relative position of the membrane 102 to the main rod 1010 to be further fixed. After the first sealing surface 101 is compressed into the delivery sheath, the membrane is sequentially arranged in the sheath to achieve a tight filling, rather than a membrane of a conventional occluder.
  • the chaotic disorder leads to a large gap, and the design reduces the size of the first sealing surface 101 of the occluding disc 10 after compression, thereby reducing the minimum diameter of the delivery sheath used and reducing the surgical approach.
  • the requirements have expanded the scope of application of the occluder.
  • the plurality of rods 1011 of each of the main rods 1010 are joined together in a partial region, such as at the edge of the sealing surface 101, via the fasteners 1012 such that the relative positions of the plurality of rods 1011 on the first sealing surface 101 are fixed.
  • the fixing member 1012 can be selected from commonly used medical materials, including nickel titanium (NiTi) alloy, cobalt chromium (CoCr) alloy, 316L stainless steel, 304 stainless steel and other metal materials, as well as polyamide (PA), polyether block amide (Pebax),
  • a polymer material such as polyurethane (TPU) can also be enhanced by adding a material having a developing function, such as a metal such as titanium, ruthenium, platinum, rhodium, tungsten or gold, an alloy thereof, and a compound such as barium sulfate or ruthenium oxide.
  • a material having a developing function such as a metal such as titanium, ruthenium, platinum, rhodium, tungsten or gold, an alloy thereof, and a compound such as barium sulfate or ruthenium oxide.
  • a fixing wire 1016 may be introduced so that the relative positions of the plurality of rods 1011 and the film of each main rod 1010 are further fixed, thereby avoiding the first film of the polymer material and the metal material such as Nitinol.
  • Embodiment 3 is a diagrammatic representation of Embodiment 3
  • the occluder of the third embodiment of the present application can be used for internal cavity, organ passage, such as patent ductus arteriosus, left atrial appendage, etc.
  • the first embodiment differs from the first embodiment in that the occluder includes a occlusion disk 10 and an anchor.
  • Rack 11 The anchoring frame 11 is placed inside the lumen or organ passage to function as a fixed occluder.
  • a wire hole 1014 is formed in the main rod 1010 of the first plugging surface 101, or a line hole is formed by a gap between the sub-rods 1011 having a mutually woven structure, and the series line 1013 connects the plurality of main rods 1010 in series through the line hole 1014.
  • FIG. 8A and the first sealing surface 101 is wrapped inside the film 102, as shown in FIG.
  • the design makes the film 102 on both sides of the first sealing surface 101 and the first sealing
  • the plugging surface 101 is firmly fixed, and there is substantially no connection force between the membrane of the polymer material and the first plugging surface 101 of the metal material such as Nitinol, and the membrane and the transport sheath are released during the release process of the occluder after repeated recovery.
  • There is friction in the inner wall of the tube and the continuous impact of the blood on the membrane after the occluder is released to the target position, causing the membrane to slide toward the central end portion 100 with respect to the main rod 1010 of the first plugging surface 101, the membrane along the first
  • the main rod 1010 of the plugging surface 101 contracts toward the center end portion 100, eventually causing the membrane 102 to be blocked.
  • the same fixation effect can be achieved by suturing the suture with the membrane 102 through the wire hole 1014.
  • the material of the series line 1013 may use a suture as described in the first embodiment, and fibers such as carbon fibers, polyarylate, and the like, and animal tendon tissue may also be used.
  • the main rod 1010' of the second plugging surface 101' may also be provided with a wired hole 1014, or a line hole may be formed by a gap between the sub-rods having a mutually woven structure, and the series line 1013 passes through the line hole. 1014 connects the plurality of main poles 1010' in series.
  • the second difference is that the first plugging surface 101 is a concave curved surface shape, and the edge of the first plugging surface 101 is bent toward the second plugging surface 101', as shown in FIG. 8b, instead of being as described.
  • the plane shown in the drawings of the first embodiment allows the first sealing face 101 and the second sealing face 101' and the connecting portion 103 to be more adapted to the anatomical shape of the end surface of the lumen or organ passage. It is also possible to embed the central end portion 100 into the lumen, the interior of the organ passage, reducing the risk of thrombosis due to the projection of the central end portion 100.
  • the third difference is that the second plugging surface 101' is formed by the plurality of sub-rods 1031 of the connecting portion 103 continuing to be cross-woven to form a lattice-like structure, and concentrated toward the center, as shown in Fig. 8C.
  • the second plugging surface 101' of the grid-like structure of the upper and lower cross-woven fabrics can further enhance the function of the joint portion having the grid-like structure, including: 1. further ensuring that the connecting portion 103 of the plugging disc 10 enters and exits the sheath tube
  • the two sealing faces 101 and 101' are kept coaxial at all times, so as to avoid the formation of the angles of the two blocking faces 101 and 101' of the sealing disk 10 due to the uneven supporting force between the respective sub-rods 1011 of the connecting portion 103.
  • the second sealing surface 101' together with the telescopic function of the connecting portion 103 makes the sealing disk 10 more adaptive to the inner cavity or organ passage of different depths; the bending function imparts the sealing disk 10 and the anchoring frame 11
  • the different axial characteristics can be adapted to the lumen or organ passage of different shafts, such as the chicken-winged left atrial appendage, which reduces the design complexity of the prior art in order to achieve the flexible connection structure.
  • Embodiment 4 is a diagrammatic representation of Embodiment 4:
  • the first embodiment differs from the third embodiment in that the occluder comprises only one occluding disc 10.
  • a fixed connection structure 1015 composed of a rod 1011 is disposed between the plurality of main rods 1010 of the first plugging surface 101.
  • This design not only exerts the same effect as the series line set in the third embodiment, but can further be further limited.
  • the relative position between all the main rods 1010 of the first plugging surface 101, so that in any case, including the occluder during repeated recycling, or during repeated release, or after being released to the target position, the first plugging All the main rods 1010 of the face 101 are kept rotationally symmetric on the central axis of the central end portion 100.
  • the membrane is further ordered in the sheath tube. Arranged to be further tightly packed, thereby further reducing the compressed body shape of the first sealing surface 101 of the occluder disk 10 of the occluder 1, minimizing the diameter of the delivery sheath used, and further reducing the surgical approach Request to expand the scope of application of the occluder.
  • the fixed connection structure 1015 can also be configured to be bent into a circular arc shape or bent into a folded shape, which is composed of the rod 1011 and is bent radially outward toward the first sealing surface 101, as shown in FIG. 9D. .
  • each of the main rods 1010 of the first plugging surface 101 is composed of a plurality of rods 1011, a part of which is cross-woven to form a joint portion 103 of a lattice-like structure, and the other portion continues to extend.
  • a plurality of rods 1011 which are separated from the adjacent main rods 1010 and continue to extend in the circumferential edge direction are respectively connected to form an extension portion 104 of the first plugging surface 101, as shown in Fig. 9C.
  • the advantage of this design is that the sealing area of the first plugging surface 101 is enlarged, as shown in Fig. 9B, to further enhance the plugging effect of the occluder.
  • the third difference is that the connecting portion 103 of the plugging disk 10 is formed by a plurality of sub-rods 1011 (that is, a part of the plurality of rods 1011 described above) by a cross-over weaving to form a three-dimensional grid-like structure, and the overall shape is a truncated cone. Shape, as shown in Figure 9C, or cylindrical, or top hat and any other shape of the surface. The upper and lower cross knitting forms a three-dimensional grid-like structure.
  • This design can not only perform the mesh-like function as described in the first embodiment, but also make the position between the plurality of sub-rods 1011 of the connecting portion 103 relatively limited but not fixed. Therefore, the connecting portion has strong shape variability.
  • the occluder When the occluder is placed at the target position, it can be directly placed on the inner wall of the inner cavity or the organ passage, and can be adapted to the inner wall of different surface states to ensure that the two are firmly attached.
  • the fixing action of the anchoring frame 11 as set in the third embodiment also produces a secondary sealing effect, further improving the sealing effect of the occluder, and further, the curved connecting portion 103 can also enhance the occluder 1
  • Anatomical adaptability reduces irritation to the inner wall of the lumen or organ passage.
  • an anchoring mechanism such as a barb, may be provided on the connecting portion 103 to further improve the fixing effect of the occluder.
  • a curved section 1032 is provided on the rod 1011 at the junction of the connecting portion 103 and the first plugging surface 101, as shown in Figs. 9C, 9E, so that the first plugging surface 101 of the plugging disc 10 is compressed into the conveying sheath
  • the entire process of releasing the tube or from the delivery sheath is smooth and smooth, avoiding the operator's large operational resistance during the whole process, so that the operation feel is not good; in addition, the connection portion 103 can be made free by setting the angle of the different curved segments. Always maintain a preset truncated cone shape, or a cylindrical shape, or a hat-like shape and any other shape of the surface.
  • the fourth difference is that, in addition to the first plugging surface 101 of the plug disk 10, the second plugging surface 101' is also covered by the film 102, and the second plugging surface 101' is coated with a film to enlarge the sealing. Block the space and improve the sealing effect.
  • Embodiment 5 is a diagrammatic representation of Embodiment 5:
  • the fifth embodiment is different from the fourth embodiment in that the connecting portion 103 of the occlusion disk 10 is intertwined by a plurality of sub-rods 1031.
  • the weave forms a three-dimensional network structure.
  • the intermittent inter-entangled woven structure is such that the sub-rods 1031 at the intersections of the mesh-like structures of the connecting portion 103 are fixedly connected, the positions between the plurality of sub-rods 1031 are relatively fixed, and the shape of the connecting portion 103 is kept good, providing a sufficiently strong
  • the radial supporting force after the occluder is placed at the target position, the connecting portion 103 is placed inside the inner cavity or the organ passage to function as a fixing of the anchoring frame 11 as set forth in the third embodiment.

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Abstract

一种封堵器，封堵器包括至少一个封堵盘；封堵盘包括中心端部、第一封堵面、第二封堵面和连接部，其中第一封堵面由从中心端部向封堵面边缘方向直接发散的多根主杆构成，第二封堵面通过连接部与第一封堵面连接，连接部由从每根主杆分开的多根子杆组成，多根子杆交叉编织构成网格状结构，在子杆上设置有弯曲段，在网格状结构中与第一封堵面相邻的多根子杆的交叉点为第一个交叉点，第一封堵面被覆膜。

Description

封堵器
相关申请
本申请要求2017年02月08日申请的，申请号为201710068510.6，名称为“封堵器”的中国专利申请的优先权，在此将其全文引入作为参考。
技术领域
本发明涉及一种经皮医疗器械领域，更具体地，涉及一种通过鞘管输送技术利用介入的方法传送到人体和/或动物体内，用于封堵其缺损开口、或组织破口、内腔、器官通道等的一种封堵器。
背景技术
介入治疗，是介于外科、内科治疗之间的新兴治疗方法，包括血管内介入和非血管介入治疗。经过30多年的发展，现在已和外科、内科一起称为三大支柱性学科。简单的讲，介入治疗就是不开刀暴露病灶的情况下，在血管、皮肤上作直径几毫米的微小通道，或经人体原有的管道，在影像设备(血管造影机、透视机、CT、MR、B超等)的引导下对病灶局部进行治疗的创伤最小的治疗方法。介入治疗具有创伤小、简便、安全、有效、并发症少和明显缩短住院时间等优点。
作为介入治疗的植入物，封堵器可用于封堵人体和/或动物体内的缺损开口、或组织破口、内腔、器官通道。例如，已在临床上得到广泛应用的先天性心脏病治疗，包括房间隔缺损(如图1所示)、室间隔缺损、动脉鞘管未闭等缺损开口的封堵，其主要的原理是将左右心房间的“漏洞”、左右心室间的"漏洞"、主动脉与肺动脉之间的通道堵住。再例如，近年来被发展用于治疗结构性心脏病，包括左心耳等内腔、器官通道的口部或内部，如将封堵器置于左心耳，以阻断进入左心耳的血流，消除由于房颤而致使左心耳形成血栓的风险，预防中风。
然而通过介入方法将封堵器送达人体和/或动物体内的缺损开口、或组织破口、内腔、器官通道所经过的入路途径，包括人体动静脉和/或心脏，过于迂曲，要求外径非常小的且柔性的鞘管，同时要求封堵器可轻松进入鞘管中且可轻松从鞘管中得以释放，因此封堵器应具有压缩后体形小(low profile)的性能。另外，封堵器应能准确到达预定部位且完全有效封堵缺损开口、内腔、器官通道，这要求封堵器具有很好的力学要求和血流动力要求，封堵器的结构必须要有很合理的设计。
现有技术中，封堵器的基本结构为超弹性的镍钛合金丝经上下交替穿插密集编织而成的自膨式双盘状或蘑菇状等结构，以形成支架主体，支架主体的内部填充有聚酯或聚四氟乙烯 等制成的膜，用于阻隔血液流入或流出缺损开口、或组织破口、内腔、器官通道。例如房间隔缺损类封堵器，左心耳类封堵器，其在心脏解剖结构中的位置如图2和图3所示。其具有结构简单的优点，但存在诸多缺点，包括
(1)封堵器采用传统的上下交替穿插编织结构，导致：
a.封堵器的封堵盘压缩进鞘管后的压缩长度远远大于其从鞘管释放后自然状态的长度，而膜的可逆形变有限，因此无法采用覆膜(所有区域的膜与丝均固定连接)设计；
b.封堵盘的丝与丝之间受到位置限制，当封堵盘放置在缺损开口、内腔、器官通道时，由于丝之间的相互牵扯，如图4A和4B所示，封堵盘难以适应口部凹凸不平的形状，形成空隙区(如标号6所示)，致使不能完全封堵目标部位，如图2和图3所示，术后有残余分流，目前这种现象在临床上屡见不鲜。
(2)现有封堵器只能通过在支架主体内部放置膜通过简单的数点缝合得以实现连接，导致：
a.除膜的边缘外，膜与封堵盘的丝之间相对位置未固定，封堵盘压缩进入输送鞘管后，膜在鞘管中排布混乱无序导致较大空隙，因此封堵器压缩后体形(profile)较大，致使所用鞘管直径较大，如左心耳类封堵器，目前能适应的最小鞘管为8-10F；这依然对血管以及血管入路的要求偏高，即目前封堵器存在一定的适应局限性；
b.膜与支架主体虽通过缝合方式进行连接，但上下交替穿插编织结构未能使膜与支架固定牢固，在出入鞘管时会使膜相对支架主体的丝滑动，甚至使缝合线断裂导致膜缩成一团，在释放封堵器时会出现膜展开不完全的现象，造成封堵不完全，有残余分流；
c.封堵盘的丝之间由于位置未相对固定，封堵器植入后，随着心脏的跳动以及血液不断冲击，易导致丝之间的相互摩擦，导致丝远期疲劳断裂的高风险；
d.通过已经形成的具有上下交替穿插编织结构的支架主体的细小网孔(如图4A所示)这一十分狭小的操作通道将膜放置进入支架主体内部、再将膜在支架主体内部铺开成圆盘状，以及最后将支架主体内部的膜与主体圆周边缘的丝进行缝合连接等系列操作较困难；
e.由于采用的膜基本为聚酯或聚四氟乙烯类的无纺布，这种无纺布虽生物相容性良好，柔软，但不适合缝合，这极易造成膜与封堵器脱离或膜被撕裂，致使不能有效封堵，通过前期的实验与使用已得到验证；
f.膜在封堵盘的内部，封堵盘的镍钛合金丝与血液等会直接接触导致镍离子析出最终导致毒性、致敏性和致畸性的风险，生物相容性欠佳；也易导致在封堵盘表面上形成血栓等并发症。
(3)目前编织封堵盘所用丝的数量较多，如32对、64对，导致：
a.金属覆盖率较高，镍离子析出导致毒性、致敏性和致畸性的风险高；
b.封堵器压缩后整体体形较大，导致所用鞘管直径较大，即目前封堵器依然存在一定的适应局限性。
发明内容
本申请的目的在于解决现有技术采用传统的上下交替穿插编织结构而无法实现覆膜引发的系列问题，提供一种易于覆膜，封堵完全，压缩后体形更小且解剖形态适应性更佳的封堵器。
本申请目的是通过以下技术方案来实现的：
一种封堵器，所述封堵器包括至少一个封堵盘；所述封堵盘包括中心端部、第一封堵面、第二封堵面和连接部，其中所述第一封堵面由从所述中心端部向封堵面边缘方向直接发散的多根主杆构成，所述第二封堵面通过所述连接部与所述第一封堵面连接，所述连接部由从每根所述主杆分开的多根子杆组成，多根所述子杆交叉编织构成网格状结构，在所述子杆上设置有弯曲段，在所述网格状结构中与所述第一封堵面相邻的多根所述子杆的交叉点为第一个交叉点，所述第一封堵面被覆膜。
本申请目的还通过以下优选的技术方案来进一步实现：
优选的，所述弯曲段被设置在所述连接部和所述第一封堵面的连接点与第一交叉点之间。
优选的，所述弯曲段被设置在所述第一交叉点与所述第二封堵面和所述连接部的连接点之间。
优选的，以所述第一交叉点为分界点，位于所述第一封堵面一侧的所述封堵器被覆膜。
优选的，所述第一封堵面被包覆在膜内。
优选的，所述第一封堵面的所述主杆被穿插固定在膜上。
优选的，所述连接部的多根所述子杆向远离所述第一封堵面的方向延伸，经交叉编织形成网格状结构，并向连接中心件汇聚形成所述第二封堵面。
优选的，所述第二封堵面的中心设置有连接中心件，所述第二封堵面由从所述连接中心件向所述第二封堵面的边缘方向直接发散的多根主杆构成，每根所述主杆在边缘处分开成多根子杆，并与所述连接部的所述子杆对应连接。
优选的，所述第二封堵面被覆膜。
优选的，在相邻的所述主杆之间设有固定连接结构。
优选的，每根所述主杆由多根杆组成，多根所述杆通过固定件合并在一起，或多根所述杆相互缠绕编织在一起。
优选的，每根所述主杆上设有线孔，串联线通过所述线孔使多根所述主杆串联成一体。
优选的，位于所述网格状结构的交叉点的所述子杆被固定连接。
优选的，每根所述主杆由多根杆组成，多根所述杆的一部分交叉编织构成网格状结构的连接部，在所述连接部与所述第一封堵面的连接处的所述杆上设置有弯曲段；多根所述杆的另一部分继续延伸，并与相邻的所述主杆分离出来的继续向圆周边缘方向延伸的多根所述杆分别连接，形成所述第一封堵面的延伸部。
优选的，所述第一封堵面为平面，或中部内凹的曲面，或所述第一封堵面的边缘向所述第二封堵面弯曲。
优选的，所述弯曲段的设置角度能够使得在自由状态时所述第一封堵面与所述连接部和所述第二封堵面贴合。
优选的，所述弯曲段的设置角度能够使得所述连接部在自由状态时为圆柱状，或圆台状，或礼帽状。
更优选的，所述封堵面的材质为镍钛合金、钴铬合金、不锈钢，钛、钽、铂、铱、钨、金、镁、锌及其合金等金属材料，或聚酰胺、聚醚嵌段酰胺、聚酰亚胺、聚氨酯、聚酮、聚烯烃等高分子材料。
更优选的，所述膜的材质为聚四氟乙烯、膨体聚四氟乙烯、聚酯、硅酮、聚氨酯、聚酰胺、硅胶、聚烯烃，或聚乳酸、聚乙烯醇等可降解材料，或者所述膜选自动物组织。
优选的，所述中心端部与推送杆可拆卸连接。
与现有技术相比，本申请的有益效果主要体现在：
1.本申请的封堵器中设置的多根主杆从中心端部向封堵面的边缘方向直接发散形成的第一封堵面结构，使得封堵器的封堵盘的第一封堵面压缩进入输送鞘管后的压缩长度等于其从输送鞘管释放后自然状态的长度，从而最终使在第一封堵面上覆膜得以实现，避免现有技术中无法实现覆膜，而采用在封堵器编织网内部放置膜通过简单的数点缝合实现膜与支架主体连接导致的一系列问题。此外，第一封堵面上的主杆之间的位置基本不受限制，运动相对独立，不仅便于生产者轻松地进行覆膜等系列生产操作，使得制作方便；还可适应凹凸不平的缺损开口区域的壁的形状，避免传统封堵器的封堵盘与缺损开口区域的间隔壁之间形成空隙区，大大提高封堵盘的解剖形态适应性，增强封堵效果。
2.本申请中第一封堵面被包覆在膜内，或第一封堵面的主杆穿插在膜上，具有诸多优点：第一封堵面内的多根主杆与膜的相对位置得到固定，第一封堵面压缩进入输送鞘管后，膜在鞘管中有序排列而实现紧密填充，减少封堵面的压缩后体形，减小所用的输送鞘管的最小直径，降低对手术入路的要求，扩大封堵器的适用范围；封堵器放置到目标位置后，与血液等大面积直接接触或完全接触的是生物相容性优良的膜，大大降低传统封堵器的镍钛合金丝与血液等的直接接触导致镍离子析出最终导致毒性、致敏性和致畸性，以及封堵器表面上 血栓形成的风险，第一封堵面完全被包覆在膜内甚至可避免这一风险；高分子材料的膜的摩擦系数比镍钛合金等金属材料的低，在封堵器从输送鞘中释放或回收过程中，摩擦阻力得以降低，使得操作者操作手感更佳。
3.本申请的封堵器中第一封堵面可设置固定连接结构，使得在封堵器回收，或释放过程中，以及释放到目标位置后，第一封堵面的所有主杆在中心端部的中心轴上均保持为旋转对称，如在重复回收过程中，第一封堵面压缩进入输送鞘管后，膜在鞘管中进一步有序排列而进一步紧密填充，因此进一步减少第一封堵面的压缩后体形，最大限度地减小所用的输送鞘管的直径，进一步降低对手术入路的要求，扩大封堵器的适用范围；同时也提高封堵器的圆整性。
4.本申请的封堵器中第一封堵面可为平面，或中心内凹的曲面，或第一封堵面的边缘向第二封堵面弯曲等任意形状的曲面，所述连接部在自由状态时可为平面，或圆台状，或圆柱状，或礼帽状，或其他任意形状的曲面，以及所述连接部有选择地设置上下交叉编织，或相互缠绕编织的结构，均可调节封堵器对目标位置的解剖形态适应性至最佳，进一步增强封堵效果。
5.本申请的封堵器中第一封堵面还可以设置延伸部，扩大第一封堵面的封堵面积，更进一步增强封堵效果。
附图说明
图1为房间隔缺损和左心耳在心脏解剖结构中的位置示意图；
图2为现有技术的房间隔缺损类封堵器在心脏中的形态示意图；
图3为现有技术的左心耳类封堵器在心脏中的形态示意图；
图4A-4B为现有技术的封堵器的封堵面(含连接部)的结构图，其中图4A为图4B的左视图；图4B为封堵盘的侧视图；
图5A-5B为本申请封堵器的第一实施例未覆膜的结构示意图，其中图5A为图5B的左视图，图5B示出了沿中心端部轴心的剖视图；
图6A-6C为本申请封堵器的第一实施例的第一封堵面被覆膜后的结构图，其中图6A为图6B的左视图，图6B示出了沿中心端部轴心的剖视图，图6C为图6B的A-A剖视图；
图7为本申请封堵器的第二个实施例的第一封堵面被覆膜后的结构示意图；
图8A-8C为本申请封堵器的第三个实施例的结构示意图，其中图8A为图8b的左视图，该视图仅显示了未被覆膜的第一封堵面结构及部分连接部(弯曲段)的结构，图8C为图8b的A-A剖视图，该视图仅显示了第二封堵面的结构及部分连接部的结构；
图9A-9E为本申请封堵器的第四个实施例的结构示意图，其中图9A，9B均为图9C的左视图，该视图仅显示未被覆膜的第一封堵面结构及部分连接部(弯曲段)结构，图 9D为图9C的右视图，该视图仅显示未被覆膜的第二封堵面结构及部分连接部(弯曲段)的结构，图9E为图9C的第一封堵面和第二封堵面均被覆膜后沿中心端部轴心的剖视图；
图10为本申请封堵器的第五个实施例仅第一封堵面覆膜后且沿中心端部轴心的剖视图。
其中，1是封堵器，3是缺损开口，4是左心房，5是右心房，6是空隙区，7内腔，10是封堵盘，11是锚定架，40是左心耳开口区域处的左心房内壁，41是左心耳内壁，42是左心耳，50是缺损开口区域处的房间隔壁，100是中心端部，101是第一封堵面，101’是第二封堵面，102是膜，103是连接部，104是延伸部，105是连接中心件，1001是连接螺母，1010是第一封堵面的主杆，1010’是第二封堵面的主杆，1011是杆，1012是固定件，1013是串联线，1014是线孔，1015是第一封堵面的固定连接结构，1015’是第二封堵面的固定连接结构，1016是固定线，1031是第一封堵面的子杆，1031’是第二封堵面的子杆，1032是弯曲段，1033是第一交叉点。
具体实施方式
为使本申请的目的、技术方案及优点更加清楚明白，以下结合附图并举实施例，对本申请进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本申请，并不用于限定本申请。
实施例一：
本申请的第一个实施例的封堵器可用于缺损开口，如房间隔缺损，室间隔缺损，以及血管等组织破口等的封堵。
如图5A-5B，以及图6A-6C所示，封堵器包括两个封堵盘10，其中任一封堵盘10均包括中心端部100、第一封堵面101、第二封堵面101’和连接部103，两个封堵盘10通过与中心端部100的中心轴同轴的连接中心件105进行连接。封堵盘10的第一封堵面101和第二封堵面101’分别由从中心端部100和连接中心件105向封堵盘的边缘方向直接发散的多根主杆1010和主杆1010’构成。所述第二封堵面101’通过所述连接部103与所述第一封堵面101连接，所述连接部103由从每根所述主杆1010分开的多根子杆1031组成，多根所述子杆1031交叉编织构成网格状结构，在所述子杆1031上设置有弯曲段1032，在所述网格状结构中与所述第一封堵面101相邻的多根所述子杆1031的交叉点为第一个交叉点1033，所述第一封堵面101被覆膜。
在这个结构中，多根主杆1010和主杆1010’分别从中心端部100和连接中心件105向封堵面的边缘方向直接发散形成第一封堵面101和第二封堵面101’，这种设计具有诸多优点：1.封堵盘10的第一封堵面101压缩进入输送鞘管后的压缩长度刚好等于其从输送鞘管释放后自然状态的长度，从而最终使在整个第一封堵面101上进行覆膜成为可能，避免现有技术中 无法实现覆膜，而不得不采用在封堵器编织网内部放置膜，再通过简单的数点缝合实现膜与支架主体连接而导致的一系列问题；2.第一封堵面101上的主杆1010之间以及第二封堵面101’上的主杆1010’之间的位置基本不受限制，运动相对独立，不仅使得第一封堵面101和第二封堵面101’适应凹凸不平的缺损开口区域的间隔壁的形状，避免传统封堵器的封堵盘与缺损开口区域的间隔壁50之间形成空隙区6(如图2所示)，大大提高了封堵盘10的解剖形态适应性，增强封堵效果，还便于生产者轻松地进行一系列覆膜生产制作，包括通过主杆1010之间或主杆1010’之间的巨大空隙放置柔软的膜进入封堵盘10的内部，将膜在其内部铺开，以及最后将其内部的膜与主杆1011进行缝合或其它连接等，使得制作方便。
在第一个实施例中，每根主杆1010或主杆1010’均由两根杆1011或1011’组成，并经相互缠绕编织等方式编织在一起形成相互缠绕的编织结构，相互缠绕的编织结构使得每根主杆1010或主杆1010’的两根杆1011或1011’之间的相对位置得到固定。第二封堵面101’通过连接部103与第一封堵面101连接，连接部103由从每根主杆1010分开的两根子杆1031组成，连接部103的多根子杆1031与第一封堵面101的多根杆1011一一对应并连接，第二封堵面101’的每根主杆1010’在封堵面101’的圆周边缘处分开成两根子杆1031’，并与连接部103的子杆1031的另一端分别对应连接，连接部103的多根子杆1031经过交叉编织构成网格状结构。交叉编织构成网格状结构的设计好处在于：1.封堵盘10的第一封堵面101压缩进入输送鞘管或者从输送鞘管中释放出时，第一封堵面101始终同轴于第二封堵面101’，进而避免因连接部103的各个子杆1031之间支撑力不均导致封堵盘10的两个封堵面101和101’形成折角进而增大出入鞘管的阻力，以及避免封堵器释放时定位不佳、释放后形态不良致使不完全封堵等的发生；2.赋予封堵盘10的连接部103一定的伸缩以及弯曲功能，连接部103的伸缩功能使封堵盘10更多地自适应较深的缺损开口或组织破口，从而第一封堵面101与第二封堵面101’与缺损开口或组织破口区域处贴壁，如图2所示的缺损开口区域处的房间隔壁50，增强封堵效果；当然弯曲功能可使第一封堵面101与第二封堵面101’不同轴，因而适应不同轴的缺损开口或组织破口。
在连接部103的子杆1031上设置有弯曲段1032，弯曲段1032可设在连接部103和第一封堵面101的连接点与第一交叉点1033之间，也可设在第一交叉点1033的靠近第二封堵面101’的一侧(即设在第一交叉点1033与第二封堵面101’和连接部103的连接点之间)，其中第一个交叉点1033被定义为在连接部103的网格状结构中与第一封堵面101相邻的多根子杆1031的交叉点，当然弯曲段1032也可以设在整个连接部上。弯曲段1032的设计使得封堵盘10的第一封堵面101压缩进入输送鞘管或者从输送鞘管中释放出的整个过程平滑顺畅，避免操作者在整个过程中操作阻力较大使得操作手感不佳；另外，通过设置不同的弯曲段的角度 (亦即：弯曲的程度)能够使得在自由状态时所述第一封堵面101与连接部103和第二封堵面101’贴合，减少第一封堵面101与第二封堵面101’之间的厚度，这样封堵器释放之后第一封堵面101连同第二封堵面101’更加贴合于缺损开口区域的房间隔壁，进一步增强封堵效果。
封堵盘10的主杆1010，1010’，或杆1011，或子杆1031，1031’由形状记忆材料制成，形状记忆材料选自镍钛(NiTi)合金、钴铬(CoCr)合金等具有形状记忆功能的金属材料，或不锈钢、钛、钽、铂、钨、金、镁、锌及其合金等其他金属材料，或聚酰胺、聚醚嵌段酰胺、聚酰亚胺、聚氨酯、聚酮、聚烯烃等高分子材料。如图5A所示的形状，封堵盘10可用多根镍钛合金丝作为杆1011以两两相互缠绕编织的方式经过初步热处理合并在一起形成相互缠绕的编织结构，使得多对杆1011的相对位置固定并形成第一封堵面101的多根主杆1010，然后多根杆1011继续向封堵面101的圆周方向延伸，经交叉编织形成连接部103的网格状结构，接着网格状结构中的每对交叉的杆以两两相互缠绕编织的方式经过初步热处理合并在一起形成相互缠绕的编织结构，使得多对杆的相对位置固定并形成第二封堵面101’的多根主杆1010’，最后用最终定型模具经过热处理将连接部103和封堵面定型成所需的形状。
第一个实施例的封堵面101的两侧均覆盖有膜102，膜102起到阻止血液流入或流出缺损开口以及血管等组织破口的作用。适用于封堵盘10的第一封堵面101的膜102的材料包括聚四氟乙烯、膨体聚四氟乙烯、聚酯、硅酮、聚氨酯弹性体、聚酰胺、硅胶、聚烯烃、可降解材料如聚乳酸、聚乙烯醇、以及动物组织等。膜102将第一封堵面101内的主杆1010或杆1011完全包覆在内部，如图6B所示，这一设计具有诸多优点：1.第一封堵面101内的多根主杆1010或多根杆1011与膜102的相对位置得到固定，第一封堵面101压缩进入输送鞘管后，膜在鞘管中有序排列而实现紧密填充，而不是传统封堵器的膜的混乱无序导致较大空隙，因此减少封堵器的封堵盘10的第一封堵面101的压缩后体形，减小所用的输送鞘管的直径，降低对手术入路的要求，扩大封堵器的适用范围；2.由于膜的生物相容性优良，封堵器放置到目标位置后，与血液等直接接触的是膜，避免了统封堵器的镍钛合金丝与血液等的直接接触导致镍离子析出最终导致毒性、致敏性和致畸性的现象，以及封堵器表面上血栓形成的发生；3.高分子材料的膜的摩擦系数比镍钛合金等金属材料的低，在封堵器从输送鞘中释放或回收过程中，摩擦阻力得以降低，使得操作者操作手感更佳。
以第一交叉点1033为分界点，位于分界点靠近第一封堵面101的一侧的连接部103也应被覆膜，如图6A-6C所示，这使得膜102的边缘与第一封堵面101牢牢固定，避免高分子材料的膜与镍钛合金等金属材料的第一封堵面101之间基本不存在连接力，而封堵器在重复回收后的释放过程中膜与输送鞘管内壁存在摩擦，以及封堵器释放到目标位置后血液对膜的不断冲击，导致膜相对于第一封堵面101的主杆1010发生向中心端部100方向的滑动，膜沿着 第一封堵面101的主杆1010向中心端部100收缩，最终致使膜102封堵不全。
若选用具有微孔结构的膜，如膨体聚四氟乙烯(ePTFE)，可将第一封堵面101两侧的膜102通过加热烧结、热熔等方式融合成一体，进行覆膜。也可在膜与膜之间通过添加粘接剂以胶连方式实现连接，粘接剂包括但不限于聚氨酯(TPU)溶液，氟化乙烯丙烯共聚物(FEP)乳液，胶水loctite3011、3321、3493、3494、3751、4011、4013、EA M-31CL；胶水Dymax203a-cth-f、204-cth-f、1201-m-sc、1128a-m；胶水NuSil MED-2000P；胶水Dow Corning SILASTIC MEDICAL ADHESIVE SILICONE,TYPE A。当然也可将第一封堵面101采用浸涂或喷涂等方式使聚氨酯(TPU)等覆盖在封堵盘上，最终完成覆膜。此外，还可使用缝合线使膜与膜缝合连接在一起，缝合线可为聚丙烯、聚酰胺、聚酯、超高分子量聚乙烯、聚四氟乙烯等不可吸收缝合线，也可为羊肠组织、聚乳酸、聚乙醇酸类等可吸收缝合线。
在一个实施方式中，中心端部100可设有具有内螺纹结构的连接螺母1001，连接螺母1001与输送系统中的推送杆可拆卸连接，旋转推送杆，释放封堵器于目标的缺损开口处，中心端部100上也可设置卡扣等其它的结构以实现与推送杆的可拆卸连接。
实施例二：
如图7所示，以第一个实施例为基础，第二个实施例与第一个实施例的不同之处在于，任一封堵盘10的第一封堵面101中，组成主杆1010的多根杆1011基本相互平行，且主杆1010穿插在膜102上。这种设计使得膜102与主杆1010的相对位置进一步固定，第一封堵面101压缩进入输送鞘管后，膜在鞘管中有序排列而实现紧密填充，而不是传统封堵器的膜的混乱无序导致较大空隙，该设计因为减少了封堵盘10的第一封堵面101压缩后的尺寸，所以减小了所用的输送鞘管的最小直径，降低了对手术入路的要求，扩大了封堵器的适用范围。每根主杆1010的多根杆1011在部分区域，如在封堵面101的边缘处经固定件1012合并在一起，使得第一封堵面101上的多根杆1011相对位置得以固定。固定件1012可选用常用的医用材料，包括镍钛(NiTi)合金、钴铬(CoCr)合金、316L不锈钢、304不锈钢等金属材料，以及聚酰胺(PA)、聚醚嵌段酰胺(Pebax)、聚氨酯(TPU)等高分子材料，还可以通过添加具有显影功能的材料，如钛、钽、铂、铱、钨、金等金属及其合金，以及硫酸钡、氧化铋等化合物，加强显影的效果，以增强手术过程中的可视化，以及便于手术后封堵器的封堵盘10最终形态的观察。在固定件1012的周边，还可引入固定线1016使得每根主杆1010的多根杆1011与膜的相对位置得到更进一步固定，避免高分子材料的膜与镍钛合金等金属材料的第一封堵面101之间基本不存在连接力，而封堵器在重复回收后的释放过程中膜与输送鞘管内壁存在摩擦，以及封堵器释放到目标位置后血液对膜的不断冲击，导致膜相对于第一封堵面101的主杆1010发生向中心端部100方向的滑动，膜沿着第一封堵面101的主杆1010向中心端部100收缩，最终致使膜102封堵不全。
实施例三：
本申请第三个实施例的封堵器可用于内腔，器官通道，如动脉导管未闭，左心耳等的封堵。
如图8A-8C所示，以第一个实施例为基础，第三个实施例与第一个实施例的第一个不同之处在于，封堵器包括一个封堵盘10和一个锚定架11。锚定架11被置于内腔或器官通道的内部，起到固定封堵器的作用。第一封堵面101的主杆1010上设置有线孔1014，或利用具有相互缠绕编织结构的子杆1011之间的缝隙形成线孔，串联线1013通过线孔1014使多根主杆1010串联成一体，如图8A所示，且所述第一封堵面101被包裹于膜102的内部，如图8b所示，这种设计使得第一封堵面101两侧的膜102与第一封堵面101牢牢固定，高分子材料的膜与镍钛合金等金属材料的第一封堵面101之间基本不存在连接力，而封堵器在重复回收后的释放过程中膜与输送鞘管内壁存在摩擦，以及封堵器释放到目标位置后血液对膜的不断冲击，导致膜相对于第一封堵面101的主杆1010发生向中心端部100方向的滑动，膜沿着第一封堵面101的主杆1010向中心端部100收缩，最终致使膜102封堵不全。当然，使用缝合线通过线孔1014与膜102进行缝合连接也可以达到同样的固定效果。串联线1013的材料可使用如第一个实施例所述的缝合线，还可使用碳纤维、聚芳酯等纤维，以及动物肌腱组织。在一个实施例中，第二封堵面101’的主杆1010’上也可设置有线孔1014，或利用具有相互缠绕编织结构的子杆之间的缝隙形成线孔，串联线1013通过线孔1014使多根主杆1010’串联成一体。
第二个不同之处在于第一封堵面101为中心内凹的曲面形状，且第一封堵面101的边缘向第二封堵面101’弯曲，如图8b所示，而不是如描述第一个实施例的附图中所示的平面，这可使第一封堵面101和第二封堵面101’以及连接部103更加适应内腔或器官通道的端面凹凸不平的解剖形状，也可使中心端部100向内腔，器官通道的内部内嵌，降低因中心端部100凸出导致的血栓形成的风险。
第三个不同之处在于第二封堵面101’是由连接部103的多根子杆1031继续经交叉编织形成网格状结构，并向中心汇聚而形成，如图8C所示。上下交叉编织的网格状结构的第二封堵面101’可进一步增强同样具有网格状结构的连接部的功能，包括：1.封堵盘10的连接部103出入鞘管时，进一步确保两个封堵面101和101’一直保持同轴，避免因连接部103的各子杆1011之间支撑力不均导致封堵盘10的两个封堵面101和101’形成折角进而增大出入鞘管的阻力，以及封堵器释放时定位不佳、释放后形态不良致使不完全封堵等的发生；2.进一步提高伸缩以及弯曲功能，当封堵器1的锚定架11放置过深或过浅，第二封堵面101’连同连接部103的伸缩功能使封堵盘10更多地自适应不同深度的内腔或器官通道；弯曲功能赋予封堵盘10与锚定架11的不同轴性，可适应不同轴的内腔或器官通道，如鸡翅状的左心耳，降 低了现有技术为了达到此目的不得不增设柔性连接结构的设计复杂度。
实施例四：
如图9A-9E所示，以第三个实施例为基础，第四个实施例与第三个实施例的第一个不同之处在于，封堵器仅包括一个封堵盘10。第一封堵面101的多根主杆1010之间设置有由杆1011组成的固定连接结构1015，这种设计不仅可发挥与第三个实施例设置的串联线相同的效果，还可以进一步限制第一封堵面101的所有主杆1010之间的相对位置，使得在任何情况下，包括封堵器在重复回收过程中，或重复释放过程中，或释放到目标位置后，第一封堵面101的所有主杆1010在中心端部100的中心轴上均保持为旋转对称，如在重复回收过程中，第一封堵面101压缩进入输送鞘管后，膜在鞘管中进一步有序排列而进一步紧密填充，因此进一步减少封堵器1的封堵盘10的第一封堵面101的压缩后体形，最大限度地减小所用的输送鞘管的直径，进一步降低对手术入路的要求，扩大封堵器的适用范围。在另一种实施方式中，固定连接结构1015也可设置为由杆1011组成的向第一封堵面101径向朝外弯曲成圆弧状或弯折成折角的形状，如图9D所示。
第二个不同之处在于，第一封堵面101的每根主杆1010由多根杆1011组成，多根杆1011的一部分交叉编织构成网格状结构的连接部103，而另一部分继续延伸，并与相邻的主杆1010分离出来的继续向圆周边缘方向延伸的多根杆1011分别连接，形成第一封堵面101的延伸部104，如图9C所示。这种设计的好处在于，扩大第一封堵面101的封堵面积，如图9B所示的I区域，进一步增强封堵器的封堵效果。
第三个不同之处在于，封堵盘10的连接部103由多根子杆1011(亦即：上述的多根杆1011的一部分)采用上下交叉编织形成立体的网格状结构，整体形状为圆台状，如图9C所示，或圆柱状，或礼帽状以及其他任意形状的曲面。上下交叉编织形成立体的网格状结构这种设计不仅可以发挥如第一个实施例所述的网格状功能，还可以使得连接部103的多根子杆1011之间的位置相对限定但不固定，因此连接部具有较强的形状可变性，当封堵器放置到目标位置后，可直接置于内腔或器官通道的内壁，并可适应不同表面状态的内壁确保二者贴合牢固，起到如第三个实施例设置的锚定架11的固定作用，同时，也产生二次密封功效，进一步提高封堵器的密封效果，此外，曲面状的连接部103还可增强封堵器1的解剖形态适应性，减少对内腔或器官通道的内壁的刺激。当然，在连接部103上还可设置锚定机构，如倒刺，进一步提高封堵器的固定效果。此外，在连接部103与第一封堵面101的连接处的杆1011上设置有弯曲段1032，如图9C，9E所示，使得封堵盘10的第一封堵面101压缩进入输送鞘管或者从输送鞘管中释放出的整个过程平滑顺畅，避免操作者在整个过程中操作阻力较大使得操作手感不佳；另外，通过设置不同的弯曲段的角度能够使得连接部103在自由状态时一直保持为预设的圆台状，或圆柱状，或礼帽状以及其他任意形状的曲面。
第四个不同之处在于，除封堵盘10的第一封堵面101外，第二封堵面101’也被覆膜102，第二封堵面101’被覆膜，可以增大封堵的空间，提高封堵效果。
实施例五：
如图10所示，以第四个实施例为基础，第五个实施例与第四个实施例的不同之处在于，封堵盘10的连接部103由多根子杆1031采用间断式相互缠绕编织形成立体网状结构。间断式相互缠绕编织结构使得位于连接部103的网格状结构的交叉点的子杆1031被固定连接，多根子杆1031之间的位置相对固定，连接部103的形状保持良好，提供足够强的径向支撑力，当封堵器放置到目标位置后，连接部103置于内腔或器官通道内部，起到如第三个实施例设置的锚定架11的固定作用。当然在交叉点的位置除了缠绕编织的固定方法外，也可通过引入其他固定件或固定线等零部件，使得网格状结构的各个交叉点均固定，产生与缠绕编织方法相同的功效。
最后应当说明的是，以上所述仅为本申请的较佳的实施例而已，并不用于限制本申请，凡在本申请的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本申请的保护范围之内。

Claims (17)

  1. 一种封堵器，其特征在于：所述封堵器包括至少一个封堵盘(10)；所述封堵盘(10)包括中心端部(100)、第一封堵面(101)、第二封堵面(101’)和连接部(103)，其中所述第一封堵面(101)由从所述中心端部(100)向封堵面边缘方向直接发散的多根主杆(1010)构成，所述第二封堵面(101’)通过所述连接部(103)与所述第一封堵面(101)连接，所述连接部(103)由从每根所述主杆(1010)分开的多根子杆(1031)组成，多根所述子杆(1031)交叉编织构成网格状结构，在所述子杆(1031)上设置有弯曲段(1032)，在所述网格状结构中与所述第一封堵面(101)相邻的多根所述子杆(1031)的交叉点为第一个交叉点(1033)，所述第一封堵面(101)被覆膜。
  2. 根据权利要求1所述的封堵器，其特征在于：所述弯曲段(1032)被设置在所述连接部(103)和所述第一封堵面(101)的连接点与第一交叉点(1033)之间。
  3. 根据权利要求1所述的封堵器，其特征在于：所述弯曲段(1032)被设置在所述第一交叉点(1033)与所述第二封堵面(101’)和所述连接部(103)的连接点之间。
  4. 根据权利要求1所述的封堵器，其特征在于：以所述第一交叉点(1033)为分界点，位于所述第一封堵面(101)一侧的所述封堵器被覆膜。
  5. 根据权利要求1所述的封堵器，其特征在于：所述第一封堵面(101)被包覆在膜内。
  6. 根据权利要求1所述的封堵器，其特征在于：所述第一封堵面(101)的所述主杆(1010)被穿插固定在膜上。
  7. 根据权利要求1所述的封堵器，其特征在于：所述连接部(103)的多根所述子杆(1031)向远离所述第一封堵面(101)的方向延伸，经交叉编织形成网格状结构，并向连接中心件(105)汇聚形成所述第二封堵面(101’)。
  8. 根据权利要求1所述的封堵器，其特征在于：所述第二封堵面(101’)的中心设置有连接中心件(105)，所述第二封堵面(101’)由从所述连接中心件(105)向所述第二封堵面(101’)的边缘方向直接发散的多根主杆(1010’)构成，每根所述主杆(1010’)在边缘处分开成多根子杆(1031’)，并与所述连接部(103)的所述子杆(1031)对应连接。
  9. 根据权利要求1或8所述的封堵器，其特征在于：所述第二封堵面(101’)被覆膜。
  10. 根据权利要求8所述的封堵器，其特征在于：在相邻的所述主杆(1010或1010’)之间设有固定连接结构(1015或1015’)。
  11. 根据权利要求8所述的封堵器，其特征在于：每根所述主杆(1010或1010’)由多根杆(1011或1011’)组成，多根所述杆(1011或1011’)通过固定件(1012或1012’)合并在一起，或多根所述杆(1011或1011’)相互缠绕编织在一起。
  12. 根据权利要求8所述的封堵器，其特征在于：每根所述主杆(1010或1010’)上设有线孔(1014)，串联线(1013)通过所述线孔(1014)使多根所述主杆(1010或1010’)串联成一体。
  13. 根据权利要求1或6所述的封堵器，其特征在于：位于所述网格状结构的交叉点的所述子杆(1031或1031’)被固定连接。
  14. 根据权利要求1所述的封堵器，其特征在于：每根所述主杆(1010)由多根杆(1011)组成，多根所述杆(1011)的一部分交叉编织构成网格状结构的连接部(103)，在所述连接部(103)与所述第一封堵面(101)的连接处的所述杆(1011)上设置有弯曲段(1032)；多根所述杆(1011)的另一部分继续延伸，并与相邻的所述主杆(1010)分离出来的继续向圆周边缘方向延伸的多根所述杆(1011)分别连接，形成所述第一封堵面(101)的延伸部(104)。
  15. 根据权利要求1所述的封堵器，其特征在于：所述第一封堵面(101)为平面，或中部内凹的曲面，或所述第一封堵面(101)的边缘向所述第二封堵面(101’)弯曲。
  16. 根据权利要求1所述的封堵器，其特征在于：所述弯曲段(1032)的设置角度能够使得在自由状态时所述第一封堵面(101)与所述连接部(103)和所述第二封堵面(101’)贴合。
  17. 根据权利要求1所述的封堵器，其特征在于：所述弯曲段(1032)的设置角度能够使得所述连接部(103)在自由状态时为圆柱状，或圆台状，或礼帽状。
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