WO2017113646A1 - 左心耳封堵器 - Google Patents

左心耳封堵器 Download PDF

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Publication number
WO2017113646A1
WO2017113646A1 PCT/CN2016/086378 CN2016086378W WO2017113646A1 WO 2017113646 A1 WO2017113646 A1 WO 2017113646A1 CN 2016086378 W CN2016086378 W CN 2016086378W WO 2017113646 A1 WO2017113646 A1 WO 2017113646A1
Authority
WO
WIPO (PCT)
Prior art keywords
left atrial
atrial appendage
fixing frame
sealing disk
proximal
Prior art date
Application number
PCT/CN2016/086378
Other languages
English (en)
French (fr)
Inventor
李安宁
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
Priority to US16/066,476 priority Critical patent/US20190015109A1/en
Priority to EP16880454.0A priority patent/EP3398536B1/en
Publication of WO2017113646A1 publication Critical patent/WO2017113646A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/12031—Type of occlusion complete occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, 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
    • A61B17/1214—Coils or wires
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, 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
    • A61B2017/00526—Methods of manufacturing
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • 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
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device

Definitions

  • the present invention relates to medical devices, and more particularly to a left atrial appendage occluder.
  • the occluder can be placed into the left atrial appendage by catheter intervention to prevent the formation of a thrombus in the left atrial appendage due to atrial fibrillation, to prevent the thrombus from reaching the stroke caused by the brain, or to prevent the thrombus from reaching the rest of the body through the human blood circulation system.
  • Such left atrial appendage occlusion devices can generally include an integrated occluder and a split occluder.
  • a split occluder typically includes a fixation member and a sealing member that are coupled to each other, the fixation member being placed in the left atrial appendage cavity to secure the entire occluder, and the sealing member sealing the mouth of the left atrial appendage for blocking blood flow inflow Left atrial appendage.
  • the anchoring member is typically placed in the left atrial appendage cavity in the form of an anchor, and the anchoring member is secured in the left atrial appendage by piercing the left atrial appendage wall.
  • the fixed component is usually placed in a deeper part of the left atrial appendage.
  • the deeper part of the left atrial appendage is also a thin part of the left atrial appendage wall, which easily causes the fixed component to puncture the left atrial appendage wall, thereby causing adverse effects such as pericardial effusion and even tamponade.
  • a left atrial appendage occluder comprising a sealing disk, a fixing frame on a distal end side of the sealing disk, and a connection between the sealing disk and the fixing frame a connector
  • the holder comprising a frame structure, the frame structure including a proximal side, and a support circumferential surface coupled to the proximal side and extending distally from the proximal side, the connector and the connector The proximal side is connected.
  • the radial deformation ability of the sealing disk is greater than the radial deformation ability of the fixing frame and/or the axial deformation ability of the sealing disk is greater than the fixing frame Axial deformation ability.
  • the change in the diameter of the sealing disk is greater than the change in the diameter of the fixed frame under the same radial force; or under the same radial force
  • the change rate of the diameter of the sealing disk is greater than the change rate of the diameter of the fixing frame; or the displacement of the sealing disk along the axial force direction is greater than the fixed frame along the same axial force
  • the amount of displacement in the direction of the axial force is greater than the change in the diameter of the fixed frame under the same radial force.
  • a left atrial appendage occluder in a naturally deployed state of the left atrial appendage occluder, the proximal side is substantially parallel to the sealing disk; and the support circumferential surface is approximately a column The proximal opening of the supporting circumferential surface is connected to the proximal side surface, and the distal opening is open and open.
  • the frame structure includes a proximal end portion and a plurality of elastic support rods, and one end of the plurality of elastic support rods is converged with the proximal end portion.
  • the other end is radially radiated from the proximal end portion to form the proximal side surface, and is bent to extend to the distal end to form the support circumferential surface; or
  • At least one of the proximal side and the support perimeter includes a plurality of meshes that are interconnected by resilient support bars.
  • the frame structure is provided with at least one anchor spur facing the sealing disk.
  • the fixing frame further includes a coating disposed on the frame structure, the coating covering at least the supporting circumferential surface.
  • the fixing frame further includes at least one anchor thorn provided on the support circumferential surface and facing the sealing disk, at least one of the anchor thorns passing through The film.
  • the connector is a flexible connector or an elastic connector.
  • the connecting member includes a proximal end end, a distal end connecting end, and a connecting body connected between the proximal end connecting end and the distal end connecting end,
  • the proximal connection end is connected to the sealing disk
  • the distal connection end is connected to the fixing frame
  • the distal connection end comprises a ball socket
  • the distal end of the connecting body comprises a match with the ball socket Ball head.
  • the connecting body is a woven structure formed of an elastic or flexible rod member, a spring structure or a plurality of elastic wires.
  • the sealing disk is a two-layer wire braided structure.
  • the invention optimizes the structure of the fixing frame in the left atrial appendage occluder, so that the proximal end of the support rod in the fixing frame is gathered and fixed by the fixed connecting member to form a closed shape, and the distal ends of the supporting rod are separated and formed into an open shape, It can ensure sufficient supporting force of the fixing frame, and each supporting rod has a certain relative independence, which can maintain good adhesion with the wall of the left atrial appendage and enhance the stable fixation performance of the fixing frame in the left atrial appendage. .
  • the fixing frame can be stably fixed in the left atrial appendage without setting an anchor thorn on the fixing frame, and the appearance of the fixing frame becomes smooth, so even if the fixing frame is disposed at a deep position of the left atrial appendage (here the cavity wall) Thinner) Don't worry about piercing the wall of the left atrial appendage.
  • FIG. 1 is a schematic diagram of a state in which a left atrial appendage occluder is implanted into a left atrial appendage according to an embodiment of the present invention.
  • FIG. 2 is a schematic structural diagram of a left atrial appendage occluder according to an embodiment of the present invention.
  • FIG. 3 is a schematic structural view of a sealing disk in the left atrial appendage occluder shown in FIG. 2.
  • FIG. 4 is a schematic structural view of a connecting member in the left atrial appendage occluder shown in FIG. 2.
  • Figure 5 is a cross-sectional view of the connector shown in Figure 4.
  • Figure 6 is a partial structural view of the connecting member shown in Figure 4.
  • Fig. 7 is a structural schematic view showing another part of the connecting member shown in Fig. 4.
  • FIG. 8 is a structural schematic view of the fixing frame in the left atrial appendage occluder shown in FIG. 2.
  • FIG. 8 is a structural schematic view of the fixing frame in the left atrial appendage occluder shown in FIG. 2.
  • FIG. 9 is a schematic structural diagram of a fixing bracket in a left atrial appendage occluder according to another embodiment of the present invention.
  • FIG. 10 is a schematic structural view of a fixing frame in a left atrial appendage occluder according to still another embodiment of the present invention.
  • Figure 11 is a schematic view showing a test method for the radial deformation capability of the holder of the left atrial appendage occluder shown in Figure 2;
  • FIG. 12 is a schematic view showing a test method for the radial deformation ability of the sealing disc of the left atrial appendage occluder shown in FIG. 2;
  • Figure 13 is a schematic view showing another specific test structure of the radial deformation ability of the sealing disc/fixing frame of the left atrial appendage occluder shown in Figure 2;
  • Figure 14 is a schematic view showing the first test method of the axial deformability of the holder of the left atrial appendage occluder shown in Figure 2;
  • Figure 15 is a schematic view showing the first test method of the axial deformability of the sealing disc of the left atrial appendage occluder shown in Figure 2;
  • Figure 16 is a schematic view showing a second test method for the axial deformability of the holder of the left atrial appendage occluder shown in Figure 2;
  • Figure 17 is a schematic illustration of a second test method for the axial deformability of the sealing disk of the left atrial appendage occluder shown in Figure 2.
  • distal refers to the end away from the operator during the procedure
  • proximal refers to the end near the operator during the procedure.
  • the left atrial appendage occluder includes a sealing disk 31, a fixing frame 33 on the distal end side of the sealing disk 31, and a connecting member 32 connecting the sealing disk 31 and the fixing frame 33.
  • the sealing disk 31 is a wire woven structure, and may be, for example, a two-layer wire woven structure.
  • the sealing disk 31 may be formed by braiding a wire (preferably a nickel-titanium material) and then heat-treating.
  • the number of wires is 16 to 144, preferably 36 to 72, and the wire diameter of the wire is 0.01 to 0.8 mm.
  • the sealing disk 31 is substantially disk-shaped and has a diameter larger than a maximum diameter of the mouth of the left atrial appendage 2. It is only necessary to select a sealing disc 31 of a size sufficient to cover the mouth of the left atrial appendage, which is suitable for the left atrial appendage 2 of various opening shapes.
  • the sealing disk 31 is disposed at the mouth of the left atrial appendage 2 and is sealed to the mouth to prevent circulation between the left atrial appendage 2 and the left atrium 1 and to block blood flow into the left atrial appendage 1.
  • the proximal wire of the sealing disk 31 is gathered and fixed by the proximal fixing member 311, and the distal wire of the sealing disk 31 is gathered and fixed by the distal fixing member 312.
  • the fixing of the proximal fixing member 311, the distal fixing member 312 and the wire of the sealing disk 31 can be achieved by a conventional method such as welding.
  • the distal fixing member 312 is fixedly connected to the connecting member 32.
  • the proximal fixation member 311 is provided with a thread that can be coupled to the conveyor for delivering the left atrial appendage occluder.
  • a sealing film (not shown) is provided inside the sealing disk 31, and the size of the sealing film is substantially the same as the size of the sealing disk 31. Specifically, the diameter of the sealing film is equal to the diameter of the sealing disk 31.
  • the sealing film is a polymer material, preferably PTFE or PET. The sealing film can be fixed by stitching or bonding to the wires constituting the sealing disk 31.
  • the connector 32 includes a proximal end connection 321, a distal end end 324, and a connecting rod 322 coupled between the proximal end connection 321 and the distal end end 324.
  • the proximal connecting end 321 is connected to the sealing disk 31. Specifically, the proximal connecting end 321 is connected to the distal end fixing member 312 of the sealing disk 31.
  • the connection method can be welding or interference fit or bonding.
  • the distal end 324 is coupled to the mount 33.
  • the connection method can be welding or interference fit or bonding.
  • the distal end end 324 includes a mating ball head structure 323 and a ball and socket structure 325.
  • the hinge mechanism of the ball head structure 323 and the ball and socket structure 325 can adjust the angle by 360°.
  • the ball head structure 323 is connected to the connecting rod 322, and the ball socket structure 325 is connected to the fixing frame 33, so that the angle between the fixing frame 33 and the connecting member 32 can also be flexibly adjusted, so that the left atrial appendage is blocked.
  • the device is capable of adapting to a wide range of left atrial appendages 2 of different shapes.
  • the proximal end 321 is connected to the proximal end 3221 of the connecting rod 322 by welding or bonding or interference fit crimping or the like.
  • the ball head structure 323 includes a convex spherical surface 3231 toward the ball and socket structure 325, and a stud 3232 that faces the connecting rod 322.
  • the ball and socket structure 325 includes a convex end 3251 that faces the holder 33, and a concave spherical surface 3252 that faces the ball head structure 323.
  • the distal end 3222 of the connecting rod 322 is coupled to the stud 3232 of the ball stud structure 323 by welding or bonding or interference fit crimping or the like.
  • the male end 3251 of the ball and socket structure 325 is coupled to the holder 33.
  • the convex spherical surface 3231 is received in the concave spherical surface 3252 to form a movable connection, so that the ball and socket structure 325 and the ball-end structure 323 can be rotated at an arbitrary angle.
  • the connector 32 can be made of a metal such as stainless steel or nickel titanium material which is more biocompatible.
  • the connecting rod 322 may be a rod having a diameter of between 0.1 and 5 mm, or may be a spring structure.
  • the connecting rod 322 and the fixing frame 33 have a hinged movable connecting characteristic, and the connecting rod 322 is also elastic, so that not only the connection angle between the connecting member 32 and the fixing frame 33 but also the length of the connecting member 32 can be adjusted.
  • the left atrial appendage occluder can be adapted to accommodate more different shapes of the left atrial appendage, and the left atrial appendage can be adapted to the left atrial appendage.
  • the fixator 33 needs to find a suitable fixed position in the left atrial appendage 2, but the fixed position will be left.
  • the length and angle adjustment of the member 32 can compensate for the angle and the relative distance between the fixing frame 33 and the sealing disk 31, and ensure that the fixing frame 33 of the left atrial appendage occluder is stably fixed at the proper position in the left atrial appendage 2
  • the sealing disc 31 and the mouth of the left atrial appendage 2 can also be optimally fitted and sealed.
  • the mount 33 includes a frame structure including a proximal side and a support perimeter extending from the proximal side to the distal end, the connector being coupled to the proximal side.
  • the proximal side may be substantially parallel to the sealing disk;
  • the supporting circumferential surface may be approximately cylindrical, including a proximal opening and a distal opening, the proximal opening being coupled to the proximal side and the distal opening being open.
  • the fixing frame 33 includes a fixing connector 331 connected to the connecting member 32, and a plurality of support bars 333.
  • the fixing connector 331 is connected to the connecting member 32.
  • the distal connecting end 324 of the connecting member 32 is connected to the fixing connecting member 331, for example, welding or bonding or interference fit crimping, etc. Way to connect.
  • the first end 3331 of the plurality of support bars 333 is gathered and fixed by a fixed connector 331, that is, the proximal end of the support bar 333.
  • the second end 3332 is radially radiated from the fixed connecting member 331 to form the proximal side surface.
  • the distal end After the bending, the distal end is axially extended to form the supporting peripheral surface, and the second end 3332 of the plurality of supporting rods 333 faces away from the distal end.
  • the connectors 32 extend in direction and are each separated, and the second end 3332 is also the distal end of the support rod 333.
  • the invention optimizes the structure of the fixing frame in the left atrial appendage occluder, so that the proximal end of the support rod in the fixing frame is gathered and fixed by the fixed connecting member to form a closed shape, and the distal ends of the supporting rod are separated and formed into an open shape, It can ensure sufficient supporting force of the fixing frame, and each supporting rod has a certain relative independence, which can maintain good adhesion with the wall of the left atrial appendage and enhance the stable fixation performance of the fixing frame in the left atrial appendage. .
  • the fixing frame can be stably fixed in the left atrial appendage without setting an anchor thorn on the fixing frame, and the appearance of the fixing frame becomes smooth, so even if the fixing frame is disposed at a deep position of the left atrial appendage (here the cavity wall) Thinner) Don't worry about piercing the wall of the left atrial appendage.
  • each support bar 333 includes a proximal arcuate segment 337, a distal arcuate segment 335, and an intermediate arcuate segment coupled between the proximal arcuate segment 337 and the distal arcuate segment 335. 336.
  • the proximal end of the proximal curved section 337 is coupled to the fixed connector 331.
  • the distal end of the distal curved section 335 is also the second end 3332 of the support rod 333.
  • the plurality of support bars 333 are enclosed in a substantially spherical space.
  • An approximate spherical space can be understood as a generally spherical shape, but not a perfectly regular spherical shape.
  • the design is such that the proximal curved section 337 is convex toward the connecting member 32, that is, the proximal curved section 337 faces a distal projection of the holder 33; the intermediate curved section 336 is convex toward the connecting member 32, that is, the intermediate curved section 336 is convex toward the distal end of the fixing frame 33;
  • the proximal curved section 337 and the intermediate curved section 336 form a generally S-shaped curve; the distal curved section 335 faces away from the central projection of the approximately spherical space.
  • the distal curved section 335 is a main component configured in a spherical shape in this embodiment, the distal curved section 335 is also the primary contact component when contacted with the lumen wall 3 of the left atrial appendage 2.
  • the distal curved section 335 of the fixing frame 33 is convex toward the center of the approximate spherical space such that the distal end of the distal curved section 335 is inwardly restrained, thereby eliminating the sharp corner of the fixing frame 33 and preventing the said The left atrial appendage occluder causes damage to the left atrial appendage 2.
  • the number of the support rods 331 is not less than two, preferably six, so that the cavity 33 of the holder 33 and the left atrial appendage 2 have sufficient contact points and areas to ensure a stable fixation effect.
  • the distal curved section 335 is provided with an anchor 334 that can face the sealing disk.
  • the anchor 334 is used to penetrate into the cavity wall 3 of the left atrial appendage 2 to assist in the fixation of the fixation frame 33. It can be understood that since the fixing frame 33 is closed at one end and the opening at one end can form a stable fit with the cavity wall 3 of the left atrial appendage 2, the anchor 334 on the fixing frame 33 can also be omitted in some embodiments. Any puncture of the lumen wall 3 of the left atrial appendage 2 is avoided.
  • the mount 33 may further include a membrane 336 that covers at least a portion of the mount 33 on which the anchor 334 is disposed.
  • the membrane 336 can also cover the entire outer surface of the holder 33.
  • the membrane 336 is disposed on the outer surface of the fixing frame 33 to prevent the blood flow from leaking into the pericardium caused by the anchor thorn 334 piercing the wall 3 of the left atrial appendage 2 due to improper selection of the specifications, and also the left atrial appendage 2 and A second seal between the left atrium 1 prevents circulation between the left atrial appendage 2 and the left atrium 1.
  • the film 336 is a polymer material and may be PTFE or PET. The film 336 can be attached to the holder 33 by stitching or bonding.
  • the fixing frame 33 can be formed by cutting a metal tube and then heat-setting. Specifically, the fixing frame 33 can be cut into a certain pattern by a metal (preferably nickel-titanium material) tube having a diameter of 0.3 to 5 mm and a length of 10 to 50 mm, and then formed by heat treatment. In other words, the fixed connection member 331 and the support rod 333 can be integrally formed.
  • a metal preferably nickel-titanium material
  • the fixing frame 33 may also be formed by heat-treating and then fixing a plurality of wires.
  • a plurality of wires having a wire diameter of 0.05 to 0.8 mm or a metal flat wire having a cross-sectional area of (0.03 to 0.5) ⁇ (0.5 to 0.03) mm, and the metal is preferably nickel-titanium.
  • the proximal end of the wire can be secured by welding to form the fixed connector 331.
  • the mount 34 has a similar shape and configuration to the mount 33 of FIG. Specifically, the holder 34 also has a fixed connector 341 and a plurality of support bars 343. The first end 3431 of the support rod 343 is gathered and fixed by the fixed connecting member 341, and the second end 3432 of the support rod 343 extends away from the connecting member 32 and is separated from each other. An anchor 344 is disposed on the support rod 343. The difference is that the holder 34 further includes a branch 348 that connects adjacent two support rods 343.
  • the branch 348 can restrain the distal curved section 345 of the support rod 343 to a certain extent, forming a mesh, so that the distal curved section 345 is not deformed and expanded due to the force, and the cavity wall 3 of the left atrial appendage 2 is reduced. risk.
  • the setting of the branch 348 can also increase the supporting force of the fixing frame 34 to some extent, and strengthen the fixing of the fixing frame 34 in the left atrial appendage 2.
  • the node to which the branch 348 is coupled to the support rod 343 is located intermediate and/or distal end of the distal curved section 345.
  • two branches 348 are disposed between the two adjacent support bars 343.
  • the two branches 348 are disposed obliquely with respect to the support bars 343, and the two branches 348 extend substantially parallel.
  • One of the branches 348 is connected in the middle of the distal curved section 345 of the adjacent two support rods 343, and the other branch 348 is connected at one end to the middle of the distal curved section 345 of one of the support rods 343, and the other end is connected The distal end of the distal curved section 345 of the other support rod 343, that is, the second end 3432 of the support rod 343.
  • the deformation ability of the sealing disk 31 is greater than the deformation capability of the fixing frame 33.
  • the deformability of a component or structure refers to the amount of deformation of the component or structure under external forces.
  • the deformability described herein can be characterized by the amount of change in the length (e.g., diameter) of the component or structure used by the radial force.
  • the radial deformation ability of the sealing disk 31 of the left atrial appendage occluder is greater than the radial deformation ability of the fixing frame 33 and/or the axial deformation ability of the sealing disk 31 is greater than the axial deformation capability of the fixing frame 33.
  • the diameter change of the sealing disk 31 is greater than the diameter change of the fixing frame 33; or under the same radial force, the diameter change rate of the sealing disk 31 is greater than the fixed frame.
  • the diameter change rate of 33; or under the same axial force, the displacement of the sealing disk 31 in the axial force direction is greater than the displacement of the fixed frame in the axial force direction.
  • the plate length method can be used to test the change of the diameter of the fixing frame and the sealing disk under the same radial force.
  • the above-described left atrial appendage occluder can be tested using the plate method.
  • a radial force F is applied to the holder 33 by the two parallel plates 61 and 62 on the premise that the sealing disk 31 is kept in a freely unfolded state.
  • parallel plates 61 and 62 are respectively placed on opposite sides of a diameter of the fixing frame 33, and radial forces F of opposite magnitudes are applied to the plates 61 and 62 respectively along the diameter;
  • the fixing frame 33 is The diameter passes through and is perpendicular to the central axis 140; the two parallel plates 61 and 62 remain parallel to each other throughout the test, ie, are always parallel to the central axis 140 during the test; any plate covers at least the maximum diameter of the fixed frame 33 At the contour, it is preferable to cover the entire holder 33 in a direction parallel to the central axis 140.
  • the radial length force F is the difference in the diameter of the fixing frame 33 before and after the radial compression, and can be expressed by ⁇ R1.
  • the diameter change rate is ⁇ R1/R1.
  • the radial force can be applied uniformly throughout the plate, the thickness of the plate being at least 5 mm.
  • the sealing plate 31 is tested by the same flat plate test method as described above, that is, the same radial force F is used, including the force F, the direction, and the action time are the same respectively, and the fixing frame 33 is naturally deployed.
  • the diameter change amount ⁇ R2 of the sealing disk 31 or the diameter change rate ⁇ R2/R2 is tested, and at this time, the maximum radial profile of the sealing disk 31 is located at the disk edge of the double-layer disk.
  • the diameter change amount ⁇ R2 of the sealing disk 31 of the left atrial appendage occluder according to the embodiment of the present invention is greater than the diameter change amount ⁇ R1 of the fixed frame 33; or
  • the diameter change rate ⁇ R2/R2 of the sealing disk 31 of the left atrial appendage occluder according to the embodiment of the present invention is larger than the diameter change rate ⁇ R1/R1 of the fixed frame 33.
  • the fixation frame may be too deep into the left atrial appendage cavity, thereby causing the natural expansion axial length of the occluder to be smaller than that after implantation.
  • the relative distance between the fixing frame and the sealing plate causes the mutual friction between the fixing frame and the sealing plate; or the occluder will move with the heart after implantation, due to the difference in the magnitude or direction of movement. It is also possible to cause mutual pulling between the fixing frame and the sealing disk. Usually, the fixing frame and the sealing disk are pulled together by the connecting member.
  • the fixing frame When the fixing frame is pulled by the sealing disk, since the fixing frame is fixed in the left atrial appendage cavity by the radial supporting force around the circumferential region of the central axis 140, the circumferential region of the left atrial appendage cavity is mainly adhered by the fixing frame. To resist this pulling force, so that the axial pulling of the fixing frame will cause its radial deformation. If the pulling effect is large enough, the fixing frame and the left atrial appendage wall may be detached, so that the left atrial appendage is sealed. The plug is detached, causing the implant to fail.
  • the sealing disk When the sealing disk is pulled by the fixing frame, since the sealing disk has a disk surface structure and is connected to the connecting member on the disk surface, the axial pulling of the sealing disk will also cause radial deformation thereof.
  • the holder and the sealing disk are pulled from each other, the one of the two that is easily deformed radially will be pulled by the other, for example, under the same radial force, the holder according to the embodiment of the invention
  • the change in the path length is smaller than the change in the diameter of the sealing disk, or the rate of change of the diameter of the fixing frame according to the embodiment of the present invention is smaller than the rate of change of the diameter of the sealing disk, and in the process of pulling each other, the fixing frame will The pulling of the sealing disk is dominated to deform the sealing disk toward the fixing frame (or toward the distal end).
  • the deformation causes the sealing disc to be closer to the left atrial wall at the opening of the left atrial appendage than the natural unfolded state, thereby improving the sealing effect of the sealing disc on the left atrial appendage opening, and avoiding the formation of a gap space between the sealing disc and the left atrial wall.
  • the stent is mainly pulled and not easily pulled by the sealing disc away from the wall of the left atrial appendage, so that the occluder is better fixed in the left atrial appendage, and the occluder is prevented from falling off from the left atrial appendage.
  • the above-mentioned flat test method is only an exemplary test method, and is not intended to limit the present invention. Those skilled in the art can perform any test equivalent to the flat test method by any suitable method, for example, also in the component to be tested.
  • the radial force is applied uniformly in the circumferential direction for testing. Specifically, referring to Fig. 13, three curved plates 63 may be uniformly arranged in the same circumferential direction at the maximum radial profile of the member to be tested (fixed frame or sealing disk), and the same diameter is simultaneously formed on the above-mentioned curved plate 63 in the test.
  • a radial force F is applied to the test, and the amount of change or rate of change of the diameter R of the component is tested.
  • the thickness of the curved plate can be set to be at least 5 mm.
  • you can also use Machine The left atrial appendage occluder was tested by Solution Inc (MSI) RX550-100 radial support tester.
  • the axis of the component can be characterized by the amount of displacement of the component in the axial direction (direction along the central axis 140) under the same axial force under the condition that a part of the component to be tested (fixed or sealed) is constrained.
  • Ability to deform In the first axial deformation capability test method, the above constraint is an equal-size constraint, that is, the component to be tested does not undergo elastic deformation or the elastic deformation variable is very small during the constraint process, and is substantially negligible; in addition, the component to be tested is selected. An axial force is applied at a position where no elastic deformation occurs.
  • the same axial force can be applied to one end of the component to be tested connected to the connecting member, and the axial displacement of the component is tested to characterize its respective deformability.
  • the axial displacement of the component is the applied point.
  • the axial displacement of the left atrial appendage occluder satisfies the axial displacement of the fixed frame less than the axial displacement of the sealing disk.
  • the holder 33 is circumferentially clamped at the maximum radial profile of the holder 33 by the annular holder 71.
  • the annular holder 71 is about the central axis 140 and perpendicular to the middle.
  • the axis 140 during the clamping process, the radial dimension of the clamping portion of the fixing frame 33 is substantially maintained in the state of the natural unfolded state, the elastic deformation is substantially negligible; the fixed connecting member 331 connected to the connecting member at the fixing frame 33, along the The axial axis 140 applies an axial force F1 toward the sealing disk 31.
  • the fixed connecting member 331 does not elastically deform during the application of the axial force F1, and the projection O1 of the fixed connecting member 331 on the central axis 140 is measured.
  • the axial displacement amount ⁇ O1 of F1 the deformation amount (or deformation ability) of the fixing frame 33 is characterized by the ⁇ O1, and the clamping state of the clamping member 71 itself remains unchanged during the entire loading process of the axial force F1. .
  • the fixing frame is clamped under the condition that a part is clamped, for example, the fixing frame 33 is clamped at the maximum contour, and the measured axial tensile force is applied.
  • the axial displacement reflects the axial deformation ability of the stent after being implanted in the left atrial appendage and being pulled by the sealing disc under the restraint of the left atrial appendage. Under the same axial tension, the larger the ⁇ O1, the easier the bracket is to be pulled and deformed.
  • the sealing plate 31 is directly clamped at the distal fixing member 312 by the clamping member 72; the proximal fixing member 311 at the sealing disk 31 is along the central axis 140 and faces away from the fixing frame.
  • the direction of 33 applies an axial force F1 which is exactly the same as the axial force during the test fixture 33.
  • the projection O2 of the proximal fixture 311 on the central axis 140 is measured with the axial displacement of F1.
  • the amount ⁇ O2 is used to characterize the amount of axial deformation (or deformability) of the sealing disk 31.
  • the sealing disc is clamped at the distal end fixing member 312 under the condition that a part of the sealing disc is clamped, and the measured axial tensile force is measured.
  • the amount of axial displacement under the action of F1 reflects the axial deformation ability of the sealing disk 31 to be pulled by the fixing frame 33 under the restraint of the tissue wall of the left atrial appendage after implantation into the left atrial appendage cavity. Under the same axial tensile force, the larger the ⁇ O2, the more easily the sealing disk 31 is pulled and deformed.
  • the axial displacement ⁇ O1 of the fixed frame is smaller than the axial displacement ⁇ O2 of the sealing disk. It can be understood that when the fixing frame and the sealing disk are pulled from each other, the one with the larger axial displacement amount will be pulled by the other side, for example, under the same axial force, according to the embodiment of the present invention.
  • the axial displacement of the holder is less than the axial displacement of the sealing disc, and during the pulling of each other, the holder will dominate the sealing disc to deform the sealing disc toward the holder (or toward the distal end).
  • the deformation causes the sealing disc to be closer to the left atrial wall at the opening of the left atrial appendage than the natural unfolded state, thereby improving the sealing effect of the sealing disc on the left atrial appendage opening, and avoiding the formation of a gap space between the sealing disc and the left atrial wall.
  • the stent is mainly pulled and not easily pulled by the sealing disc away from the wall of the left atrial appendage, so that the occluder is better fixed in the left atrial appendage, and the occluder is prevented from falling off from the left atrial appendage.
  • a second axial deformation capability test method can also be employed.
  • the annular holder 75 is used to clamp the holder 33 circumferentially at the maximum radial profile of the holder 33.
  • the annular clamping member is about the central axis 140 and perpendicular to the central axis 140.
  • the radial dimension of the clamping portion of the fixing frame 33 is smaller than that in the naturally unfolded state, and the fixing frame 33 is radially compressed at the clamping position.
  • the maximum diameter after compression is 80% of the maximum path length before compression.
  • other compression ratios may also be used, which are not enumerated here.
  • a radial force F0 can be applied to the annular clamp 76 to radially compress the mount 33.
  • the fixed connecting member 331 connected to the connecting member 33 and the connecting member applies an axial force F2 along the central axis 140 and toward the sealing disk 31.
  • the fixed connecting member 331 does not elastic during the application of the axial force F2. Deformation, the projection O3 of the fixed connection member 331 on the central axis 140 is measured by the axial displacement amount ⁇ O3 of F2, and the deformation amount (or deformation ability) of the fixing frame 33 is characterized by the ⁇ O3.
  • the fixing frame 33 is clamped under the condition that a part is clamped, for example, the fixing frame 33 is clamped at the maximum contour, and the measured axial tensile force is applied.
  • the amount of axial displacement reflects the deformability of the stent 33 being pulled by the sealing disk 31 under the restraint of the left atrial appendage after implantation into the left atrial appendage. Under the same axial tensile force, the larger the ⁇ O3, the more easily the fixing frame 33 is pulled and deformed.
  • the sealing disk 31 includes a distal end mount 312 that is coupled to the distal end mount 312.
  • a ring-shaped fastener 77 is used to abut the disk surface at a maximum edge of the sealing disk 31 facing a disk surface of the mounting frame 33 while being along the central axis 140 at the distal fixing member 312 and facing
  • the direction of the holder 33 applies an axial force F2, and during the axial stretching of F2, the position of the abutted disk surface in the direction of the central axis 140 is maintained by the ring-shaped fastener 77, thereby testing the distal end fixing.
  • the amount of projection displacement of the piece 312 on the central axis 140 is ⁇ O4.
  • the measured sealing disc is under axial tension under the condition that the annular fastener abuts the sealing disc toward the largest radial edge of the fixing frame and keeps it from being displaced along the central axis 140.
  • the axial displacement reflects the deformability of the sealing disc being pulled by the holder at the left atrial appendage after implantation in the human body. Under the same axial tensile force, the larger the ⁇ O4, the easier the sealing disc is to be pulled and deformed.
  • the axial displacement ⁇ O3 of the fixing frame is smaller than the axial displacement ⁇ O4 of the sealing disk. It can be understood that when the fixing frame and the sealing disk are pulled from each other, the one with the larger axial displacement amount will be pulled by the other side, for example, under the same axial force, according to the embodiment of the present invention.
  • the axial displacement of the holder is less than the axial displacement of the sealing disc, and during the pulling of each other, the holder will dominate the sealing disc to deform the sealing disc toward the holder (or toward the distal end).
  • the deformation causes the sealing disc to be closer to the left atrial wall at the opening of the left atrial appendage than the natural unfolded state, thereby improving the sealing effect of the sealing disc on the left atrial appendage opening, and avoiding the formation of a gap space between the sealing disc and the left atrial wall.
  • the stent is mainly pulled and not easily pulled by the sealing disc away from the wall of the left atrial appendage, so that the occluder is better fixed in the left atrial appendage, and the occluder is prevented from falling off from the left atrial appendage.
  • the left atrial appendage occluder provided by the present invention has the following beneficial effects:
  • the fixing frame is a structure in which one end of at least two support rods is closed and the other end is open, and has elasticity and a smooth appearance.
  • the fixed frame When the fixed frame is placed in a suitable position in the left atrial appendage, it will be compressed, and its support rod can provide strong supporting force to the left atrial appendage, ensuring stable fixation without causing damage to the wall of the left atrial appendage.
  • An anchor thorn can be further arranged on the fixing frame to facilitate the anchor piercing into the left atrial appendage wall, which is helpful for fixing the left atrial appendage occluder.
  • the membrane is also a second seal between the left atrial appendage and the left atrium, preventing circulation between the left atrial appendage and the left atrium.
  • the sealing disk is a disk-shaped body woven from a plurality of wires and has good elasticity.
  • the sealing disc is placed at the mouth of the left atrial appendage and can be well fitted to the mouth of the left atrial appendage for optimal sealing.
  • a thread is provided at the proximal end of the sealing disk to enable connection to the conveyor.
  • the connector has elasticity and good bending resistance, and the length and angle between the sealing disc and the fixing frame can be adjusted.
  • the length and angle between the sealing disc and the fixing frame are compensated to ensure a stable fixing effect and at the same time achieve an optimal sealing effect.

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Abstract

一种左心耳封堵器，包括密封盘（31）、位于密封盘（31）远端一侧的固定架（33）、以及连接密封盘（31）和固定架（33）的连接件（32）。固定架（33）包括框架结构，框架结构包括近端侧面、以及与近端侧面连接并从近端侧面向远端延伸的支撑周面。连接件（32）与近端侧面连接。该左心耳封堵器将固定架（33）设置为至少两个支撑杆（333）组成的一端呈封闭、另一端呈开放的结构，可以保证固定架（33）足够的支撑力；同时每个支撑杆（333）之间又有一定的相对独立性，能和左心耳的腔壁保持较好的贴覆性，增强固定架（33）在左心耳中的稳固性能，无需锚刺也可稳固于左心耳中，可避免对左心耳腔壁造成损伤。

Description

左心耳封堵器
【技术领域】
本发明涉及医疗器械，尤其涉及一种左心耳封堵器。
【背景技术】
目前可通过导管介入方法放置封堵器到左心耳中，预防由于房颤而致左心耳形成血栓，避免该血栓上行至大脑造成的中风；或预防该血栓通过人体血液循环系统到达身体其他部位，造成的系统性栓塞。此类左心耳封堵器从结构上可大致包括一体式封堵器和分体式封堵器。例如，分体式封堵器通常包括彼此连接的固定部件和密封部件，固定部件置于左心耳腔体中以固定整个封堵器，密封部件密封左心耳的口部，用于阻断血流流入左心耳腔体内。
对于此类分体式封堵器，通常采用锚的形式将固定部件置于左心耳腔体中，通过锚刺入左心耳壁而使固定部件在左心耳腔体中予以固定。为了降低封堵器脱落的风险，通常将固定部件置于左心耳腔内较深部位。但是左心耳腔内较深部位也是左心耳壁较薄部位，容易导致固定部件刺破左心耳壁，由此引发心包积液，甚至心包填塞等不良后果。
【发明内容】
基于此，有必要针对上述问题，提供一种能保障稳固效果，且又能降低刺破左心耳壁的风险的左心耳封堵器。
本发明解决其技术问题所采用的技术方案是：提供了一种左心耳封堵器，包括密封盘、位于密封盘远端一侧的固定架，以及连接所述密封盘和所述固定架的连接件，所述固定架包括框架结构，所述框架结构包括近端侧面、以及与所述近端侧面连接并从所述近端侧面向远端延伸的支撑周面，所述连接件与所述近端侧面连接。
在依据本发明实施例的左心耳封堵器中，所述密封盘的径向变形能力大于所述固定架的径向变形能力和/或所述密封盘的轴向变形能力大于所述固定架的轴向变形能力。
在依据本发明实施例的左心耳封堵器中，在相同径向力作用下，所述密封盘的径长变化量大于所述固定架的径长变化量；或者在相同径向力作用下，所述密封盘的径长变化率大于所述固定架的径长变化率；或者在相同轴向力作用下，所述密封盘沿所述轴向力方向的位移量大于所述固定架沿所述轴向力方向的位移量。
在依据本发明实施例的左心耳封堵器中，在所述左心耳封堵器的自然展开状态下，所述近端侧面与所述密封盘基本平行；且所述支撑周面近似为柱面，所述支撑周面的近端开口与所述近端侧面连接、远端开口悬空开放。
在依据本发明实施例的左心耳封堵器中，所述框架结构包括近端端部和多个弹性支撑杆，所述多个弹性支撑杆的一端均与所述近端端部汇聚相连，另一端均从所述近端端部沿径向辐射伸出形成所述近端侧面、弯折后向远端轴向延伸形成所述支撑周面；或者，
所述近端侧面和所述支撑周面中的至少一个包括多个由弹性支撑杆互连围成的网格。
在依据本发明实施例的左心耳封堵器中，所述框架结构上设有至少一个朝向所述密封盘的锚刺。
在依据本发明实施例的左心耳封堵器中，所述固定架还包括设于所述框架结构上的覆膜，所述覆膜至少覆盖所述支撑周面。
在依据本发明实施例的左心耳封堵器中，所述固定架还包括至少一个设于所述支撑周面上的、且朝向所述密封盘的锚刺，至少一个所述锚刺穿过所述覆膜。
在依据本发明实施例的左心耳封堵器中，所述连接件为柔性连接件或弹性连接件。
在依据本发明实施例的左心耳封堵器中，所述连接件包括近端连接端、远端连接端以及连接在所述近端连接端和所述远端连接端之间的连接体，所述近端连接端与所述密封盘连接，所述远端连接端与所述固定架连接，所述远端连接端包括球窝，所述连接体的远端包括与所述球窝配合的球头。
在依据本发明实施例的左心耳封堵器中，所述连接体为弹性或柔性杆件、弹簧结构或多根弹性丝形成的编织结构。
在依据本发明实施例的左心耳封堵器中，所述密封盘为双层丝编织结构。
本发明通过优化左心耳封堵器中的固定架的结构，使固定架中的支撑杆的近端收拢并被固定连接件固定形成封闭状，而支撑杆的远端各自分离形成开放状，既可以保证固定架足够的支撑力，同时每个支撑杆之间又有一定的相对独立性，能和左心耳的腔壁保持较好的贴覆性，增强固定架在左心耳中的稳定固定性能。固定架因具有上述特征使得固定架上无需设置锚刺也可稳定固定于左心耳中，固定架的外表变得光滑，因而即使将固定架设置在左心耳的较深位置处（此处腔壁较薄）也不用担心会刺破左心耳的腔壁。
【附图说明】
图1为本发明一实施例提供的左心耳封堵器植入左心耳中的状态示意图。
图2为本发明一实施例提供的左心耳封堵器的结构示意图。
图3为图2所示左心耳封堵器中的密封盘的结构示意图。
图4为图2所示左心耳封堵器中的连接件的结构示意图。
图5为图4中所示连接件的剖视图。
图6为图4所示连接件的部分结构示意图。
图7为图4所示连接件的另一部分结构示意图。
图8为图2所示左心耳封堵器中的固定架的结构示意图。
图9为本发明另一实施例提供的左心耳封堵器中的固定架的结构示意图。
图10为本发明又一实施例提供的左心耳封堵器中的固定架的结构示意图。
图11为图2所示的左心耳封堵器的固定架的径向变形能力的测试方法示意图；
图12为图2所示的左心耳封堵器的密封盘的径向变形能力的测试方法示意图；
图13为图2所示的左心耳封堵器的密封盘/固定架的径向变形能力的另一具体测试结构示意图；
图14是图2所示的左心耳封堵器的固定架的轴向变形能力的第一种测试方法示意图；
图15是图2所示的左心耳封堵器的密封盘的轴向变形能力的第一种测试方法示意图；
图16是图2所示的左心耳封堵器的固定架的轴向变形能力的第二种测试方法示意图；
图17是图2所示的左心耳封堵器的密封盘的轴向变形能力的第二种测试方法示意图。
【具体实施方式】
为了更加清楚地描述左心耳封堵器的结构，本发明限定术语“远端”和“近端”，上述术语为介入医疗器械领域的惯用术语。具体而言，“远端”表示手术过程中远离操作者的一端，“近端”表示手术过程中靠近操作者的一端。
图1示出了依据本发明实施例的左心耳封堵器植入左心耳后的示意图，左心耳2位于左心房1内、二尖瓣（图未示）与左上肺静脉4之间。同时参考图2，左心耳封堵器包括密封盘31、位于密封盘31远端一侧的固定架33、以及连接密封盘31与固定架33的连接件32。
同时参考图3，所述密封盘31为丝编织结构，例如可以是双层丝编织结构。密封盘31可由金属丝（优选镍钛材料）编织后，通过热处理后成型而成。金属丝的数量为16~144根，优选36~72根，金属丝的丝径为0.01~0.8mm。所述密封盘31大致呈盘状，且直径大于所述左心耳2口部的最大直径。只需要选取足以掩盖左心耳2口部的规格的密封盘31即可适宜于各种开口形状的左心耳2。所述密封盘31设置在左心耳2的口部并对该口部密封，防止左心耳2和左心房1之间建立流通，阻挡血流进入左心耳1。
密封盘31的近端金属丝由近端固定件311收拢并固定，密封盘31的远端金属丝由远端固定件312收拢并固定。近端固定件311、远端固定件312与密封盘31的金属丝的固定可以采用焊接等常用的方式实现。所述远端固定件312与所述连接件32固定连接。进一步地，所述近端固定件311上设有螺纹，可以与输送器连接，以便输送所述左心耳封堵器。
进一步地，密封盘31的内部设有一层密封膜（图未示），密封膜的大小基本和密封盘31的大小相同。具体的，所述密封膜的直径与所述密封盘31的直径相等。所述密封膜为高分子材料，优选PTFE或PET。密封膜可通过缝合或粘接的方式和构成密封盘31的金属丝固定。
参考图4和图5，所述连接件32包括近端连接端321、远端连接端324以及连接在近端连接端321和远端连接端324之间的连接杆322。
所述近端连接端321与密封盘31连接，具体地，所述近端连接端321与密封盘31的远端固定件312连接。连接方式可以为焊接或过盈配合或粘接等。
所述远端连接端324与固定架33连接。连接方式可以为焊接或过盈配合或粘接等。
所述远端连接端324包括相互配合的球头结构323和球窝结构325。球头结构323和球窝结构325构成的铰链机构，可以360°调整角度。所述球头结构323与连接杆322连接，所述球窝结构325与固定架33连接，因而所述固定架33与连接件32之间的角度也可灵活调整，使得所述左心耳封堵器能够更大范围的适应不同形状的左心耳2。
同时参考图5、图6和图7，近端连接端321与连接杆322的近端3221以焊接或粘接或过盈配合压接等方式连接。球头结构323包括朝向球窝结构325的凸球面3231，以及朝向连接杆322的凸柱3232。球窝结构325包括朝向固定架33的凸端3251，以及朝向球头结构323的凹球面3252。连接杆322的远端3222与球头结构323的凸柱3232以焊接或粘接或过盈配合压接等方式连接。球窝结构325的凸端3251与固定架33连接。凸球面3231容置在凹球面3252内，形成活动连接，从而使球窝结构325与球头结构323可达成任意角度的转动。
连接件32可由生物相容性较好的不锈钢或镍钛材料等金属制成。连接杆322可以为直径在0.1~5mm之间的杆状物，也可以是弹簧结构。连接杆322与固定架33具有铰链式的活动连接特性，且连接杆322还具有弹性，因而不但可变换连接件32与固定架33之间的连接角度，还可调整连接件32的长度，使得所提供的左心耳封堵器能适应更多不同形状的左心耳，以及置入左心耳后能适应左心耳的自身活动。
如图1所示，所述的左心耳封堵器植入弯角较大的左心耳2中后，固定架33需要在左心耳2中找一个合适的固定位置，但该固定位置会和左心耳2的口部存在较大夹角，也就是说当左心耳封堵器放入左心耳2后，固定架33与密封盘31之间存在较大夹角及相对较大的距离，通过连接件32的长度及角度的调整，可以补偿固定架33与密封盘31之间存在的夹角及相对距离，保证左心耳封堵器的固定架33在左心耳2中合适的位置稳定固定的同时，也可以使密封盘31与左心耳2的口部达到最佳贴合而密封的效果。
固定架33包括框架结构，该框架结构包括近端侧面、以及与近端侧面连接从从近端侧面向远端延伸的支撑周面，连接件与近端侧面连接。在自然展开状态下，近端侧面可以与密封盘基本平行；支撑周面可以近似为柱面，包括近端开口和远端开口，其近端开口与近端侧面连接，远端开口悬空开放。
具体参考图8，一实施例中，所述固定架33包括与连接件32连接的固定连接件331，以及多个支撑杆333。所述固定连接件331与连接件32连接，具体地，所述连接件32中的远端连接端324与所述固定连接件331连接，例如可采用焊接或粘接或过盈配合压接等方式连接。所述多个支撑杆333的第一端3331由固定连接件331收拢并固定，所述第一端3331也即支撑杆333的近端端部。第二端3332从固定连接件331沿径向辐射伸出形成上述近端侧面，弯折后向远端轴向延伸形成上述支撑周面，所述多个支撑杆333的第二端3332朝向远离连接件32的方向延伸且各自分离，所述第二端3332也即支撑杆333的远端。
本发明通过优化左心耳封堵器中的固定架的结构，使固定架中的支撑杆的近端收拢并被固定连接件固定形成封闭状，而支撑杆的远端各自分离形成开放状，既可以保证固定架足够的支撑力，同时每个支撑杆之间又有一定的相对独立性，能和左心耳的腔壁保持较好的贴覆性，增强固定架在左心耳中的稳定固定性能。固定架因具有上述特征使得固定架上无需设置锚刺也可稳定固定于左心耳中，固定架的外表变得光滑，因而即使将固定架设置在左心耳的较深位置处（此处腔壁较薄）也不用担心会刺破左心耳的腔壁。
更具体地，参考图8，每一支撑杆333包括近端弧形段337、远端弧形段335和连接在近端弧形段337和远端弧形段335之间的中间弧形段336。所述近端弧形段337的近端与固定连接件331连接。所述远端弧形段335的远端也即所述支撑杆333的第二端3332。所述固定架33在自然展开状态下，所述多个支撑杆333围设成近似球状空间。近似球状空间可以理解为轮廓大致为球形，但是又不是完全规则的球形。在本实施例中，为了使支撑杆333具有更好的支撑强度，设计使得所述近端弧形段337背向所述连接件32凸起，也即所述近端弧形段337朝向所述固定架33的远端凸起；所述中间弧形段336朝向所述连接件32凸起，也即所述中间弧形段336背向所述固定架33的远端凸起；所述近端弧形段337和中间弧形段336形成大致为S形曲线；所述远端弧形段335背向所述近似球状空间的中心凸起。其中所述远端弧形段335在本实施例中为构造成球形形状的主要部件，在与左心耳2的腔壁3接触固定时，所述远端弧形段335也是主要的接触部件。所述固定架33的远端弧形段335背向所述近似球状空间的中心凸起，使得其远端弧形段335的远端内敛，可消除固定架33具有尖端的棱角，防止所述左心耳封堵器对左心耳2造成损伤。
支撑杆331的数量不少于两根，优选为6根，使得固定架33和左心耳2的腔壁3具有足够的接触支点和面积，确保稳定固定的效果。
在一些实施例中，所述远端弧形段335上设有锚刺334，该锚刺334可以朝向密封盘。所述锚刺334用于刺入左心耳2的腔壁3内，以协助固定架33的固定。可以理解，由于固定架33采用一端封闭、一端开放的结构已然能够与左心耳2的腔壁3形成稳固的贴合，因此固定架33上的锚刺334在一些实施例中也可以省去，避免对左心耳2的腔壁3的任何刺破。
参考图9，在另外的一些实施例中，所述固定架33还可以包括膜336，所述膜336至少覆盖固定架33上设有锚刺334的部位。膜336也可以覆盖固定架33的整个外表面。膜336被设置在固定架33的外表面上，可以阻止因规格选择不当时，锚刺334刺破左心耳2的腔壁3而导致的血流外泄到心包中，同时也是左心耳2和左心房1之间的第二道密封，阻止左心耳2和左心房1之间建立流通。膜336为高分子材料，可以是PTFE或PET。膜336可用缝合或粘接的方式附着在固定架33上。
所述固定架33可以由金属管切割后经热处理定型而成。具体地，固定架33可以通过直径为0.3~5mm、长度为10~50mm的金属（优选镍钛材料）管子切割成一定的花纹，再通过热处理定型而成。换言之，固定连接件331和支撑杆333可以一体成型。
在另外的一些实施例中，固定架33也可以由多根金属丝经热处理后再固定连接而成。例如可通过多根丝径为0.05~0.8mm的金属丝或截面积为（0.03~0.5）×（0.5~0.03）mm的金属扁丝通过热处理而成，金属优选镍钛。金属丝的近端可通过焊接方式固定以形成所述固定连接件331。
如图10所示，在另外的一些实施例中，固定架34具有与图8所示固定架33类似的形状与结构。具体地，固定架34也具有固定连接件341以及多个支撑杆343。支撑杆343的第一端3431由固定连接件341收拢并固定，支撑杆343的第二端3432朝向远离连接件32的方向延伸且各自分离。支撑杆343上设置锚刺344。不同之处在于，所述固定架34还包括连接相邻两个支撑杆343的分枝348。分枝348可以一定程度约束支撑杆343的远端弧形段345，形成网格，使远端弧形段345不至于因受力导致变形外扩，减少刺破左心耳2的腔壁3的风险。同时分枝348的设置也可一定程度提升固定架34的支撑力，加强固定架34在左心耳2中的固定。
优选地，所述分枝348与支撑杆343连接的节点位于远端弧形段345的中间及/或远端。在一具体的实施例中，相邻两个支撑杆343之间连接设置有两个分枝348，两个分枝348相对支撑杆343呈倾斜设置，两个分枝348延伸方向大致平行。其中一个分枝348连接在相邻两个支撑杆343的远端弧形段345的中间，另一个分枝348一端连接在一个支撑杆343的远端弧形段345的中间，另一端连接在另一个支撑杆343的远端弧形段345的远端，也即支撑杆343的第二端3432。
在本发明的一具体实施方式中，所述密封盘31的变形能力大于所述固定架33的变形能力。某个部件或结构的变形能力，指的是该部件或结构在外力作用下的变形量的大小。在本发明中，此处所说的变形能力可以采用径向力所用下部件或结构的径长（例如直径）变化量进行表征。
进一步地，上述左心耳封堵器的密封盘31的径向变形能力大于固定架33的径向变形能力和/或密封盘31的轴向变形能力大于固定架33的轴向变形能力。具体而言，在相同径向力作用下，密封盘31的径长变化量大于固定架33的径长变化量；或者在相同径向力作用下，密封盘31的径长变化率大于固定架33的径长变化率；或者在相同轴向力作用下，密封盘31沿轴向力方向的位移量大于固定架沿轴向力方向的位移量。
可采用平板法分别测试固定架和密封盘在相同径向力作用下的径长变化情况。例如，参见图11和12，可采用平板法测试上述左心耳封堵器。
参见图11，首先，在密封盘31保持自由展开状态的前提下，通过两块平行平板61和62对固定架33施加径向作用力F。具体地，分别在固定架33的一直径的相对两侧置放平行平板61和62，沿该直径在平板61和62上分别施加大小相同方向相反的径向作用力F；上述固定架33的直径穿过并垂直于中轴线140；两块平行平板61和62在整个测试过程中保持彼此平行状态，即测试过程中均始终与中轴线140平行；任一平板至少覆盖固定架33的最大径向轮廓处，优选可在平行于中轴线140的方向上覆盖整个固定架33。若自然展开状态下固定架33加载平板处的径长为R1，则在径向力F的作用下固定架33的径长变化量为径向压缩前后的径长差值，可用△R1表示，径长变化率为△R1/R1。为了确保径向力施加过程中，平板自身不变形，从而径向力可在平板各处均匀施加，平板的厚度至少为5mm。
参见图12，采用上述同样的平板测试方法对密封盘31进行测试，即采用相同的径向作用力F，包括作用力F大小、方向、作用时间均分别相同，在固定架33处于自然展开的前提下，测试密封盘31的径长变化量△R2或者径长变化率△R2/R2，此时密封盘31的最大径向轮廓处位于双层盘的盘边缘。基于上述测试条件，在相同的径向力作用下，依据本发明实施例的左心耳封堵器的密封盘31的径长变化量△R2大于固定架33的径长变化量△R1；或者，依据本发明实施例的左心耳封堵器的密封盘31的径长变化率△R2/R2大于固定架33的径长变化率△R1/R1。
在左心耳封堵器植入人体后，可能会出现植入位置选择不恰当的情况，例如固定架可能因过于深入左心耳腔体，从而造成封堵器的自然展开轴向长度小于植入后的固定架与密封盘的相对距离，使得固定架与密封盘之间发生互相牵拉作用；或者，封堵器在植入后将随着心脏一起运动，因各处运动幅度或方向的不同，也可能使得固定架与密封盘之间发生互相牵拉作用，通常，固定架与密封盘之间通过连接件进行相互牵拉。
当固定架受到密封盘的牵拉时，因固定架通过绕中轴线140的周向区域的径向支撑力固定于左心耳腔体内，因此主要将由固定架紧贴左心耳腔体的周向区域来抵抗这种牵拉作用力，这样，针对固定架的轴向牵拉将造成其径向变形，若牵拉作用足够大，将可能造成固定架与左心耳腔壁脱离，从而使得左心耳封堵器脱落，造成植入失效。当密封盘受到固定架的牵拉时，因密封盘为盘面结构，且在盘面上与连接件相连，因此针对密封盘的轴向牵拉同样将造成其径向变形。
由此，当固定架与密封盘彼此牵拉时，两者中易径向变形的一方将被另一方主导牵拉，例如，在相同的径向作用力下，依据本发明实施例的固定架的径长变化量小于密封盘的径长变化量，或者依据本发明实施例的固定架的径长变化率小于密封盘的径长变化率，则在彼此的牵拉的过程中，固定架将主导牵拉密封盘，使密封盘朝向固定架方向（或朝向远端）变形。这种变形使得密封盘相比自然展开状态更加紧贴左心耳开口处的左心房壁，从而提高了密封盘对左心耳开口的封闭效果，避免在密封盘与左心房壁之间形成间隙空间，从而防止血流经该间隙空间流入左心耳腔体内，以及防止血栓经该间隙空间流入左心房内，造成中风或系统性栓塞。同时，固定架主导牵拉而不易被密封盘牵拉脱离左心耳腔壁，使封堵器更好地固定在左心耳中，避免封堵器从左心耳中脱落。
上述的平板测试方法仅为一种示例测试方法，并不是对本发明的限制，本领域的普通技术人员可采用任意适合的方法进行与平板测试方法等效的测试，例如，还可在待测部件的周向上均匀施加径向作用力进行测试。具体地，参见图13，可在待测部件（固定架或密封盘）的最大径向轮廓处的同一周向上均匀布置三个弧形板63，测试中在上述弧形板63上同时沿径向施加径向作用力F，并测试部件的径长R的变化量或变化率。同样地，为了实现径向力的均匀施加，可设置弧形板的厚度至少为5mm。另外，也可采用Machine Solution Inc（MSI）公司RX550-100型号的径向支撑力测试仪对左心耳封堵器进行测试。
另外，可在待测部件（固定架或密封盘）的一部分被约束的条件下，通过在相同轴向力作用下测试部件的轴向（沿中轴线140方向）位移量来表征该部件的轴向变形能力。在第一种轴向变形能力测试方法中，上述约束为等尺寸约束，即在约束过程中待测部件不发生弹性形变或弹性形变量非常小，基本可忽略；另外，选择在待测部件的不发生弹性形变的位置处施加轴向作用力。例如，可分别在待测部件与连接件相连的一端部施加相同的轴向作用力，测试部件的轴向位移量来表征其各自的变形能力，此处部件的轴向位移量即为施力点处的轴向位移量，左心耳封堵器满足固定架的轴向位移量小于密封盘的轴向位移量。测试中对固定架和密封盘分别进行独立测试，例如每次仅测试单个固定架或单个密封盘。
参见图14，测试固定架33过程中，采用环形夹持件71在固定架33的最大径向轮廓处沿周向夹持固定架33，该环形夹持件71绕中轴线140并垂直于中轴线140，夹持过程中，固定架33的夹持处的径向尺寸基本保持为自然展开状态下的尺寸，弹性形变基本可忽略；在固定架33与连接件相连的固定连接件331，沿中轴线140并朝向密封盘31的方向施加轴向作用力F1，该固定连接件331在施加轴向作用力F1的过程中不发生弹性形变，测量固定连接件331在中轴线140上的投影O1随F1的轴向位移量△O1，采用该△O1表征固定架33的变形量（或变形能力），轴向作用力F1的整个加载过程中，夹持件71自身的夹持状态保持不变。
从以上可以看出，左心耳封堵器植入人体后，固定架在一部分被夹持住的条件下，例如固定架33在最大轮廓处被夹持住，测得的轴向拉力作用下的轴向位移量反应了该固定架在植入左心耳腔体后，在左心耳腔体的束缚作用下被密封盘牵拉的轴向变形能力。相同轴向拉力下，△O1越大，则表明固定架越易于被牵拉变形。
参见图15，测试密封盘31过程中，采用夹持件72在远端固定件312处直接夹持密封盘31；在密封盘31的近端固定件311，沿中轴线140并朝向远离固定架33的方向施加轴向作用力F1，该轴向作用力与测试固定架33过程中的轴向作用力完全相同，测量近端固定件311在中轴线140上的投影O2随F1的轴向位移量△O2，采用该△O2表征密封盘31的轴向变形量（或变形能力）。
从以上可以看出，左心耳封堵器植入人体后，密封盘在一部分被夹持住的条件下，例如密封盘31在远端固定件312处被夹持住，测得的轴向拉力F1作用下的轴向位移量反应了该密封盘31在植入左心耳腔体后，在左心耳口部的组织壁的束缚作用下被固定架33牵拉的轴向变形能力。相同轴向拉力下，△O2越大，则表明密封盘31越易于被牵拉变形。
测得在相同轴向力作用下，固定架的轴向位移量△O1小于密封盘的轴向位移量△O2。可以理解，当固定架与密封盘彼此牵拉时，两者中轴向位移量较大的一方将被另一方主导牵拉，例如，在相同的轴向作用力下，依据本发明实施例的固定架的轴向位移量小于密封盘的轴向位移量，则在彼此的牵拉的过程中，固定架将主导牵拉密封盘，使密封盘朝向固定架方向（或朝向远端）变形。这种变形使得密封盘相比自然展开状态更加紧贴左心耳开口处的左心房壁，从而提高了密封盘对左心耳开口的封闭效果，避免在密封盘与左心房壁之间形成间隙空间，从而防止血流经该间隙空间流入左心耳腔体内，以及防止血栓经该间隙空间流入左心房内。同时，固定架主导牵拉而不易被密封盘牵拉脱离左心耳腔壁，使封堵器更好地固定在左心耳中，避免封堵器从左心耳中脱落。
还可采用第二种轴向变形能力测试方法，参见图16，测试固定架33过程中，采用环形夹持件76在固定架33的最大径向轮廓处沿周向夹持固定架33，该环形夹持件绕中轴线140并垂直于中轴线140，夹持过程中，固定架33的夹持处的径向尺寸小于自然展开状态下的尺寸，固定架33在夹持处被径向压缩，例如压缩后的最大径长为压缩之前的最大径长的80%，当然，也可采用其它的压缩比例，此处不再一一列举。例如，可在环形夹持件76施加径向力F0，径向压缩固定架33。在固定架33与连接件相连的固定连接件331，沿中轴线140并朝向密封盘31的方向施加轴向作用力F2，该固定连接件331在施加轴向作用力F2的过程中不发生弹性形变，测量固定连接件331在中轴线140上的投影O3随F2的轴向位移量△O3，采用该△O3表征固定架33的变形量（或变形能力）。
从以上可以看出，左心耳封堵器植入人体后，固定架33在一部分被夹持住的条件下，例如固定架33在最大轮廓处被夹持住，测得的轴向拉力作用下的轴向位移量反应了该固定架33在植入左心耳腔体后，在左心耳腔体的束缚作用下被密封盘31牵拉的变形能力。相同轴向拉力下，△O3越大，则表明固定架33越易于被牵拉变形。
参见图17，密封盘31包括远端固定件312，连接件与远端固定件312相连。独立测试密封盘31过程中，采用环形固件77在密封盘31的朝向固定架33的一盘面上的最大边沿处，抵持该盘面，同时在远端固定件312处沿中轴线140、并朝向固定架33的方向施加轴向作用力F2，在F2的轴向拉伸过程中，通过环形固件77使得被抵持的盘面处保持沿中轴线140方向的位置不变，由此测试远端固定件312在中轴线140上的投影位移量△O4。
从以上可以看出，左心耳封堵器植入人体后，密封盘的一部分在左心耳口部被左心房腔壁抵挡，其中至少是密封盘朝向固定架的最大径向边沿被抵挡，因此，上述密封盘的测试过程中，在环形固件抵持密封盘朝向固定架的最大径向边沿处并保持其不沿中轴线140方向发生位移的条件下，测得的密封盘在轴向拉力作用下的轴向位移量反应了该密封盘在植入人体后，在左心耳开口处被固定架牵拉的变形能力。相同轴向拉力下，△O4越大，则表明密封盘越易于被牵拉变形。
测得在相同轴向力（F2）的作用下，固定架的轴向位移量△O3小于密封盘的轴向位移量△O4。可以理解，当固定架与密封盘彼此牵拉时，两者中轴向位移量较大的一方将被另一方主导牵拉，例如，在相同的轴向作用力下，依据本发明实施例的固定架的轴向位移量小于密封盘的轴向位移量，则在彼此的牵拉的过程中，固定架将主导牵拉密封盘，使密封盘朝向固定架方向（或朝向远端）变形。这种变形使得密封盘相比自然展开状态更加紧贴左心耳开口处的左心房壁，从而提高了密封盘对左心耳开口的封闭效果，避免在密封盘与左心房壁之间形成间隙空间，从而防止血流经该间隙空间流入左心耳腔体内，以及防止血栓经该间隙空间流入左心房内。同时，固定架主导牵拉而不易被密封盘牵拉脱离左心耳腔壁，使封堵器更好地固定在左心耳中，避免封堵器从左心耳中脱落。
综上，本发明提供的左心耳封堵器具有以下有益效果：
（1）固定架为至少两个支撑杆组成的一端呈封闭、另一端呈开放的结构，具有弹性，外表光滑。当固定架放于左心耳中的适合位置后，会被压缩，其支撑杆可以对左心耳提供较强的支撑力，保证稳定固定，同时不会对左心耳的腔壁造成损伤。在固定架上可进一步设有锚刺，便于锚刺刺入左心耳壁，有助于左心耳封堵器的固定。也可以在固定架上附着一层膜，可以阻止因规格选择不当时，锚刺刺破左心耳壁而导致的血流外泄到心包中。该膜同时也是左心耳和左心房之间的第二道密封，阻止左心耳和左心房之间建立流通。
（2）密封盘是由多根金属丝编织而成的盘状体，具有良好的弹性。密封盘被置于左心耳的口部，可以良好的贴合左心耳的口部，达到最佳密封。在密封盘的近端设有螺纹，可以实现和输送器的连接。
（3）连接件具有弹性，抗弯性能较好，可以调整密封盘和固定架之间的长度和角度，当不同的左心耳解剖结构要求密封盘和固定架具有不同轴的构造时，可对密封盘和固定架之间长度及角度进行补偿，既保证稳定的固定效果，同时可以达到最佳的密封效果。
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 (12)

  1. 一种左心耳封堵器，包括密封盘、位于密封盘远端一侧的固定架，以及连接所述密封盘和所述固定架的连接件，其特征在于，所述固定架包括框架结构，所述框架结构包括近端侧面、以及与所述近端侧面连接并从所述近端侧面向远端延伸的支撑周面，所述连接件与所述近端侧面连接。
  2. 根据权利要求1所述的左心耳封堵器，其特征在于，所述密封盘的径向变形能力大于所述固定架的径向变形能力和/或所述密封盘的轴向变形能力大于所述固定架的轴向变形能力。
  3. 根据权利要求2所述的左心耳封堵器，其特征在于，在相同径向力作用下，所述密封盘的径长变化量大于所述固定架的径长变化量；或者在相同径向力作用下，所述密封盘的径长变化率大于所述固定架的径长变化率；或者在相同轴向力作用下，所述密封盘沿所述轴向力方向的位移量大于所述固定架沿所述轴向力方向的位移量。
  4. 根据权利要求1-3任一项所述的左心耳封堵器，其特征在于，在所述左心耳封堵器的自然展开状态下，所述近端侧面与所述密封盘基本平行；且所述支撑周面近似为柱面，所述支撑周面的近端开口与所述近端侧面连接、远端开口悬空开放。
  5. 根据权利要求4所述的左心耳封堵器，其特征在于，
    所述框架结构包括近端端部和多个弹性支撑杆，所述多个弹性支撑杆的一端均与所述近端端部汇聚相连，另一端均从所述近端端部沿径向辐射伸出形成所述近端侧面、弯折后向远端轴向延伸形成所述支撑周面；或者，
    所述近端侧面和所述支撑周面中的至少一个包括多个由弹性支撑杆互连围成的网格。
  6. 根据权利要求1-3任一项所述的左心耳封堵器，其特征在于，所述框架结构上设有至少一个朝向所述密封盘的锚刺。
  7. 根据权利要求1-3任一项所述的左心耳封堵器，其特征在于，所述固定架还包括设于所述框架结构上的覆膜，所述覆膜至少覆盖所述支撑周面。
  8. 根据权利要求7所述的左心耳封堵器，其特征在于，所述固定架还包括至少一个设于所述支撑周面上的、且朝向所述密封盘的锚刺，至少一个所述锚刺穿过所述覆膜。
  9. 根据权利要求1-3任一项所述的左心耳封堵器，其特征在于，所述连接件为柔性连接件或弹性连接件。
  10. 根据权利要求9所述的左心耳封堵器，其特征在于，所述连接件包括近端连接端、远端连接端以及连接在所述近端连接端和所述远端连接端之间的连接体，所述近端连接端与所述密封盘连接，所述远端连接端与所述固定架连接，所述远端连接端包括球窝，所述连接体的远端包括与所述球窝配合的球头。
  11. 根据权利要求10所述的左心耳封堵器，其特征在于，所述连接体为弹性或柔性杆件、弹簧结构或多根弹性丝形成的编织结构。
  12. 根据权利要求1-3任一项所述的左心耳封堵器，其特征在于，所述密封盘为双层丝编织结构。
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