WO2017016411A1 - 一种左心耳封堵器 - Google Patents

一种左心耳封堵器 Download PDF

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Publication number
WO2017016411A1
WO2017016411A1 PCT/CN2016/090413 CN2016090413W WO2017016411A1 WO 2017016411 A1 WO2017016411 A1 WO 2017016411A1 CN 2016090413 W CN2016090413 W CN 2016090413W WO 2017016411 A1 WO2017016411 A1 WO 2017016411A1
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WO
WIPO (PCT)
Prior art keywords
anchoring
left atrial
atrial appendage
net
appendage occluder
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PCT/CN2016/090413
Other languages
English (en)
French (fr)
Inventor
王永胜
张庭超
訾振军
Original Assignee
杭州诺茂医疗科技有限公司
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=54212312&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2017016411(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 杭州诺茂医疗科技有限公司 filed Critical 杭州诺茂医疗科技有限公司
Priority to US15/746,132 priority Critical patent/US11026694B2/en
Priority to EP16829777.8A priority patent/EP3329864A4/en
Publication of WO2017016411A1 publication Critical patent/WO2017016411A1/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
    • A61B17/12—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
    • 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
    • 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
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • 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
    • A61B17/12168—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
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • 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
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect

Definitions

  • the invention relates to the technical field of medical instruments, in particular to a left atrial appendage occluder.
  • Atrial fibrillation is the most common persistent arrhythmia. As you age, the incidence of atrial fibrillation increases, reaching 10% in people over 75 years of age.
  • the frequency of atrial excitement during atrial fibrillation is 300-600 beats/min.
  • the heart rate is often fast and irregular, and the atrium loses its effective contractile function.
  • the left atrial appendage contraction force decreases during atrial fibrillation, and the morphological characteristics of the left atrial appendage and the trabecular convexity and concavity in the left atrial appendage cause vortex and flow velocity in the left atrial appendage to slow down and promote thrombosis. More than 90% of left atrial thrombus in patients with non-valvular atrial fibrillation is present in the left atrial appendage. After the thrombus falls off, it will enter the brain arterial blood vessels through the aorta to form a cerebral embolism, that is, stroke.
  • Anticoagulant therapy refers to the inhibition of blood coagulation by taking anticoagulant drugs (such as warfarin, aspirin) to reduce the risk of thrombosis in the left atrial appendage, thereby reducing the incidence of stroke.
  • anticoagulant drugs such as warfarin, aspirin
  • Clinical trials have shown that anticoagulant therapy can significantly reduce the incidence of stroke, but anticoagulant therapy is a long process, and there are also obvious complications, mainly as bleeding complications, and may be more serious.
  • Surgical treatment includes surgical resection or suturing the left atrial appendage, but the surgical trauma is large, usually completed during other operations such as valve replacement or coronary artery bypass grafting. It is generally difficult for patients to receive simple left atrial appendage surgery, especially in elderly patients.
  • Percutaneous left atrial appendage occlusion treatment refers to the delivery of a left atrial appendage occluder to the left atrial appendage located in the left atrium of the heart by percutaneous puncture using a small diameter delivery sheath.
  • the left atrial appendage occluder can block the opening position of the left atrial appendage, and the blood flow in the atrium cannot enter the left atrial appendage, so It can not form a thrombus, so as to prevent thromboembolism induced by atrial fibrillation.
  • percutaneous left atrial appendage treatment has been put into use, and animal experiments and clinical trials have been carried out. Clinical trials have shown that left atrial appendage occlusion can effectively reduce the incidence of stroke in patients with atrial fibrillation.
  • the left atrial appendage occluder is basically made of nickel-titanium alloy and polymer material coating.
  • the nickel-titanium alloy mainly plays a fixed role, and the polymer material film mainly serves to block blood flow.
  • left atrial appendage occlusion devices are mainly divided into two types.
  • the first type is a plug structure that is placed directly into the left atrial appendage with barbs for fixation.
  • This structure of the left atrial appendage occluder usually requires the sheath to be deeper into the left atrial appendage, so It is easy to pierce the left atrial appendage and cannot be repeatedly released.
  • the second type consists of a occlusion disk and an anchor plate.
  • the occlusion disk seals the left atrial appendage opening in the left atrium.
  • the anchor plate is placed inside the left atrial appendage and has a barb.
  • the left atrial appendage occluder of the second structure mainly blocks the left atrial appendage by means of a sealing disc. When releasing, it is necessary to ensure that the sealing disc is reliably fitted and sealed in the left atrial appendage opening position.
  • the occlusion disc does not fit in the left atrial appendage opening position after release, and the anchor disc cannot be retracted, it will lead to surgical failure and may further increase the risk of thrombosis, so the releasable release of the anchor disc Very important.
  • anchoring disc capable of achieving repeated release, but the entire anchoring disc is not fixedly fixed inside the left atrial appendage, but is fixed by several partial regions, which causes these several The stress concentration in the area, and the barbs in these areas will also pierce the left atrial appendage wall, which in turn leads to complications such as pericardial effusion.
  • the present invention provides a left atrial appendage occluder that can be evenly attached to the inner wall of the left atrial appendage and enables repeated release.
  • a left atrial appendage occluder comprising an interconnecting sealing disc and an anchoring device, the anchoring device cooperating with the left atrial appendage is an anchoring net, and the anchoring net is a boneless structure.
  • the left atrial appendage occluder provided by the invention is transported through a delivery catheter by percutaneous puncture
  • the anchoring device is used to anchor the entire left atrial appendage occluder
  • the sealing disk blocks the opening position of the left atrial appendage
  • a thrombus forms in the left atrial appendage, which in turn leads to stroke.
  • the anchoring net is mesh-shaped and adopts a boneless structure, and can be evenly attached to the inner wall of the left atrial appendage, thereby realizing the position of the occluder at the opening portion of the left atrial appendage, and at the same time, the anchoring net is at the position of the sealing disc Improper, can not completely fit the opening of the left atrial appendage to achieve the closure, can return to the income delivery device, achieve repeated release, significantly improve the success rate of surgery.
  • the anchoring net is in surface contact with the left atrial appendage, and the anchoring force is evenly distributed on the contact surface between the anchoring net and the left atrial appendage, thereby eliminating local stress concentration. , reducing the risk of puncture of the left atrial wall.
  • the anchoring device has a rolled structure from the inside to the outside, the inner edge portion of the rolled structure is connected to the sealing disk, and the peripheral portion of the rolled structure is an anchoring net that cooperates with the left atrial appendage.
  • the anchoring device is an inner and outer double layer structure, and the anchoring net is located at the outer periphery of the inner edge portion.
  • the anchoring mesh encloses at least one-half of the axial length of the inner edge portion.
  • the anchor web is rolled over to a proximal end adjacent the inner edge portion.
  • the anchoring net should have a sufficiently long extension path when rolling, and the turning angle.
  • the turning angle of the rolled structure is greater than or equal to 180 degrees based on the axis of the anchoring device, as a further preferred turning angle is greater than or equal to 270 degrees.
  • the proximal end of the inner edge portion is converged with the sealing disk.
  • Proximal converging means that the inner edge portion is gradually gathered toward the side of the sealing disk, and then joined to the sealing disk, preferably to the central region in the radial direction of the sealing disk.
  • the specific connection may be an inseparable fixed connection, such as a unitary structure, or welding, or a detachable connection, such as a snap, threaded or transitional connection.
  • the inner edge portion is a compressible hollow structure. At least it can be compressed in the radial direction in order to be inserted through the blood vessel.
  • the inner edge portion is a mesh structure or a plurality of link structures.
  • the anchoring device is entirely boneless.
  • the anchoring device of the present invention does not have a skeleton structure.
  • the force distribution is uniform when interacting with the inner wall of the left atrial appendage, especially the anchoring net has no skeleton structure, so that the anchoring net and the left atrial appendage Force distribution on the contact surface of the inner wall Uniform, boneless structure also ensures that the anchoring device has good compliance and is easy to adapt to different internal anatomy of the left atrial appendage.
  • the boneless structure in the present invention means that no anchoring structure is provided in the anchoring device or the anchoring net, so that the mechanical properties of each part of the anchoring device or the anchoring net are kept uniform, and stress concentration does not occur. On the skeleton structure.
  • a skeletal structure is arranged in the anchoring device.
  • the interaction force between the left atrial appendage and the anchoring device is concentrated on the skeletal structure, and the inner wall of the left atrial appendage is easily affected. Excessive force creates stress concentration, which in turn has the risk of piercing the left atrial appendage.
  • the anchoring net is woven from a metal wire or cut into a metal tube.
  • the anchoring net is a part of the anchoring device that is in contact with the left atrial appendage, and other parts of the anchoring device, such as the inner edge portion of the rolled structure, may be processed in the same or different manner as the anchoring net portion, and the same
  • the anchoring device is made of a wire braid or a metal tube.
  • the anchoring device is woven from at least one wire, which is a superelastic wire or a memory alloy wire.
  • the anchoring net is nested (ie, bowl shaped).
  • the superelastic wire or memory alloy wire is made of nickel-titanium wire.
  • the anchoring net has a regularly distributed cell structure.
  • Each cell adopts a diamond-shaped or approximately diamond-shaped structure, and the anchoring net is a rotating curved surface, and an intersection point of an arbitrary latitude circle on the rotating curved surface and a cell of the anchoring net is evenly distributed along the rotating axis.
  • the distal end of the inner rim portion is open and rolled outward toward the proximal end to form the anchoring mesh, and the anchoring mesh encloses the inner rim portion.
  • the distal end and the proximal end of the present invention are relative to the operator, the end of the occluder closer to the operator being the proximal end and the end remote from the operator being the distal end.
  • the anchoring mesh engages the distal end of the inner edge portion through the arcuate transition zone.
  • the inner edge portion has a conical shape, a pyramidal shape, a truncated cone shape, a prismatic shape, a cylindrical shape, a waist drum shape or a bellows shape.
  • the tendency of the inner edge portion to close (close) on the side close to the sealing disk can be various, and when the inner edge portion is uniformly folded as a whole, the inner edge portion is tapered as a whole.
  • the inner edge portion is only converged in a small area near the side of the sealing disk, and the portion far from the sealing disk accounts for the majority and is determined.
  • the overall shape of the inner edge portion In the case of a truncated cone shape, a prismatic shape, a cylindrical shape, a waist drum shape or a bellows shape, it can be considered that the inner edge portion is only converged in a small area near the side of the sealing disk, and the portion far from the sealing disk accounts for the majority and is determined.
  • the overall shape of the inner edge portion is only converged in a small area near the side of the sealing disk, and the portion far from the sealing disk accounts for the majority and is determined.
  • the inner edge portion is a mesh structure
  • the inner edge portion is a conical mesh
  • the anchor net and the conical mesh form an inner and outer two-layer structure
  • the anchor net is located at the outer periphery of the conical net, and one end of the conical net is connected with the sealing disc.
  • the anchoring mesh engages the bottom edge of the tapered mesh (the distal end of the inner edge portion) through the arc transition zone.
  • the anchoring net is a rotating surface, and the busbar of the rotating surface is a straight line or an arc.
  • the opening of the arc faces the interior of the anchoring net
  • the anchoring net has a curved surface
  • the curved surface of the curved surface is smoothly connected with the arc transition zone.
  • the anchoring net When the busbar is straight and parallel to the axis, the anchoring net is nest-shaped, and the nest shape and the arc transition zone are smoothly connected.
  • the anchoring net When the busbar is straight and inclined with the axis, the anchoring net has a truncated cone shape, and the lower bottom of the truncated cone (the larger bottom) is arranged close to the sealing disc, and the upper base of the truncated cone is smoothly connected with the arc transition zone.
  • the anchoring device is woven from a superelastic wire or a memory alloy wire.
  • the nest end of the nested anchoring net is bent inwardly to form a cuffing region.
  • the cuffing region is radially bent toward the center end, and the end point of the superelastic wire or the memory alloy wire is hidden inside the anchoring net through the cuffing region, thereby reducing the possibility of direct contact with the inner wall of the left atrial appendage, thereby reducing the left
  • the venting area is first released by the conveying device, and is woven by a superelastic wire or a memory alloy wire, and the clogging area is self-floating and curling after being detached from the conveying device.
  • the part of the anchoring device that is in contact with the left atrial appendage is always a transitional part of the arc to avoid damage to the left atrial appendage.
  • the anchoring net is provided with a plurality of barbs, and when the anchoring net is in an axially stretched compression state, the barbs are disposed on the anchoring net. Inner side.
  • the barbs are inclined along the circumferential direction of the superelastic wires or memory alloy wires of the anchoring mesh. That is, the barbs are radially outwardly turned along the anchoring net, and the barbs are inclined along the axial direction of the anchoring net.
  • the barbed structure provided by the invention can ensure the repeated release of the occluder, and when released in the human body, the barb can effectively penetrate the inner wall of the left atrial appendage and anchor the position of the occluder if the sealing disk is The position is not suitable, the position of the opening of the left atrial appendage cannot be well sealed, and the occluder needs to be retracted and released.
  • the barb is on the anchoring net, that is, in the outer layer, when the traction center end is recovered
  • the outer layer and the inner layer move in opposite directions.
  • the outer layer also enters the conveying device. Since the barb is at the outer layer, the direction of the barb movement is first and the direction of penetration. Instead, the barbs can be smoothly withdrawn from the inner wall of the left atrial appendage and then returned to the delivery device in the direction of traction.
  • the barb is disposed at at least one of a circular arc transition zone, an anchoring mesh, or a cuffing zone.
  • the barbs are fixed to the anchoring wire by a ferrule or by welding.
  • the barb is made of a superelastic wire or a memory alloy wire, and is distinguished from a superelastic wire or a memory alloy wire of an anchoring net, which is called a barbed wire, and the barbed wire can be used.
  • a superelastic wire or a memory alloy wire of an anchoring net which is called a barbed wire
  • the barbed wire can be used.
  • the ferrule can be made of metal.
  • the barbed root extends along the attached wire to the proximal end of the anchoring device (e.g., the inner end of the inner tapered mesh). That is, one end of the barbed wire is fixed to the center end of the anchoring net, and is in parallel with a superelastic wire or a memory alloy wire on the anchoring net, and is used at the other end of the barbed wire. a ferrule (such as a steel sleeve), or a weld that secures the barbed wire with a parallel superelastic wire or a memory alloy wire.
  • the end of the barbed wire extends a fixed point of 1 to 5 mm and is anchored to the anchoring mesh. The outside is opened at an angle to form the barb.
  • one end of the barbed wire is inside the ferrule, and the other end extends out of the ferrule by 1 to 5 mm to form the barb.
  • one end of the barbed wire is welded and fixed to at least one superelastic wire or memory alloy wire of the braided anchoring net, and the other end extends out of the ferrule by 1 to 5 mm to form the Barbed.
  • the length of the barbed wire is short, generally not exceeding 10 mm.
  • the choke film is made of a medical polymer material such as PET or PTFE which is flexible.
  • the sealing disk is woven from at least one superelastic wire or memory alloy wire.
  • the superelastic wire or the memory alloy wire may be a nickel titanium wire.
  • the sealing disk is a mesh structure.
  • the sealing disk includes a disk surface and a waist that are connected to each other:
  • the disk surface is on a side away from the anchoring net, and the center of the disk surface is provided with a first fixed end for connecting the conveying device;
  • the waist is on a side near the anchoring net, and the center of the waist is provided with a second fixed end for connecting the anchoring net.
  • the multilayer blocking film in order to provide the multilayer blocking film, the multilayer blocking film is not mutually provided. Interference, and the flow blocking effect can cooperate with each other to significantly improve the flow blocking effect, structurally improve the sealing disk, and increase the waist portion capable of accommodating the multilayer blocking film.
  • the waist portion comprises:
  • a tubular body portion is formed at the periphery of the diffusion section, the top edge of the body section is connected to the disk surface, and the bottom edge of the body section is connected to the outer edge of the diffusion section.
  • the diffusion section is radiated and diffused outward from the second fixed end to form a plane or a conical surface, and the second fixed end may also be slightly closer to the disc surface.
  • the body segment is a rotating surface, and the outer circumference of the body segment is equal to or larger than the outer circumference of the anchoring net.
  • the top edge of the body segment and the disk surface are smoothly connected, and a circular arc transitions between a bottom edge of the body segment and an outer edge of the diffusion segment.
  • the flow blocking film is two, one on the surface of the disk and the other in the body section of the waist or on the diffusion section.
  • the length of the disk surface in the axial direction is small, the choke film is located in the disk surface, the length of the waist body segment is longer in the axial direction, and the choke film may be located inside the waist body segment or on the diffusion section.
  • the flow blocking film is three sheets, one on the surface of the disk, one in the body section of the waist, and one on the diffusion section.
  • the left atrial appendage occluder provided by the invention can be anchored uniformly inside the left atrial appendage, eliminate local stress concentration, and can realize reproducible release, and effectively and reliably block the opening portion of the left atrial appendage.
  • FIG. 1 is a schematic overall view of a left atrial appendage occluder of Embodiment 1;
  • FIG. 2 is a schematic view of a sealing disk in the left atrial appendage occluder of Embodiment 1;
  • Figure 3a is a schematic view of the anchoring device in the left atrial appendage occluder of Embodiment 1;
  • Figure 3b is a schematic view (another angle) of the anchoring device in the left atrial appendage occluder of Embodiment 1;
  • Figure 4 is a schematic view showing the steel sleeve connecting the sealing disk and the anchoring device in the first embodiment
  • Figure 5 is a schematic view showing the structure of a nickel-titanium wire of the frame of the braiding anchoring device in the first embodiment
  • Figure 6a is a schematic view showing the connection of the nickel-titanium wire used as the barb in Example 1 to the nickel-titanium wire of the frame of the braiding anchoring device;
  • Figure 6b is an enlarged view of a portion A in Figure 6a;
  • FIG. 7a is a schematic view of a mesh tube woven during the process of making an anchoring device in Embodiment 1;
  • Figure 7b is an enlarged view of a portion B in Figure 7a;
  • Figure 8 is a schematic view showing the end of the mesh tube woven in the first embodiment after being gathered and welded;
  • Figure 9 is a schematic view showing the welding of the center end of the anchoring device in Example 1 without adding a steel sleeve;
  • Figure 10 is a schematic view of the left atrial appendage occluder of Example 1 after being released in the left atrial appendage;
  • Figure 11a is a schematic view showing the connection of the nickel-titanium wire used as the barbed wire and the nickel-titanium wire of the frame of the braiding anchoring device in the second embodiment;
  • Figure 11b is an enlarged view of a portion C of Figure 11a;
  • Figure 12a is a schematic view of the left atrial appendage occluder of Embodiment 2;
  • Figure 12b is an enlarged view of a portion D in Figure 12a;
  • Figure 13a is a schematic view showing the connection of the nickel-titanium wire used as the barb in Example 3 to the nickel-titanium wire of the frame of the braiding anchoring device;
  • Figure 13b is an enlarged view of a portion E of Figure 13a;
  • Figure 14a is a schematic view of the left atrial appendage occluder of Embodiment 3;
  • Figure 14b is an enlarged view of a portion F in Figure 14a;
  • Figure 15a is a schematic view of the anchoring device of Embodiment 4.
  • Figure 15b is a schematic view (another angle) of the anchoring device of Embodiment 4.
  • Figure 16a is a schematic view of the anchoring device of Embodiment 5.
  • Figure 16b is a schematic view (another angle) of the anchoring device of Embodiment 5;
  • Figure 17a is a schematic view of the anchoring device of Embodiment 6;
  • Figure 17b is a schematic view (another angle) of the anchoring device of Embodiment 6;
  • Figure 18 is a schematic view of a sealing disk in Embodiment 7.
  • Figure 19 is a schematic overall view of the left atrial appendage occluder of Embodiment 7;
  • FIG. 20 is a schematic view of the left atrial appendage occluder of Example 7 after being released in the left atrial appendage;
  • Figure 21a is a schematic view of the preparation of the release anchoring net in Embodiment 1;
  • Figure 21b is a schematic view showing the release region of the anchoring net in Embodiment 1;
  • Figure 21c is a schematic view showing the release of the anchoring device in Embodiment 1;
  • Figure 22a is a schematic view showing the completion of the recovery of the sealing disk in the first embodiment, preparing the recovery anchoring device;
  • Figure 22b is a schematic view showing the partial recovery of the anchoring device in the first embodiment
  • Figure 22c is a schematic illustration of the recovery anchoring device of Example 1 with the barbs completely withdrawn from the left atrial appendage wall.
  • the left atrial appendage occluder 100 of the present invention is comprised of a sealing disk 110 and an anchoring device 120.
  • the sealing disk 110 is a mesh structure woven by nickel-titanium wire. As shown in FIG. 2, the sealing disk 110 is composed of a disk surface 111 and a waist portion 112. A first fixed end 113 is provided at the center of the disk surface, and the center of the waist portion 112 is provided. There is a second fixed end 114, a layer of PET blocking film 115 is slit in the disk surface, and at least one layer of the blocking film 116 is sewn in the waist 112.
  • the first fixed end 113 is for connection to a delivery device and the second fixed end 114 is coupled to the anchoring device 120.
  • the waist portion 112 includes a diffusion section 117 radiated outwardly from the second fixed end 114, and a tubular body portion 118 having a cylindrical shape at the periphery of the diffusion section 117.
  • the top edge of the body section 118 is connected to the disk surface 111.
  • the bottom edge of the 118 and the outer edge of the diffuser section 117 are transitionally connected by a circular arc 119, and the baffle film 116 in the waist portion 112 is located in the middle of the axial direction of the body section 118.
  • the diffusion section 117 is radiated and diffused outward by the second fixed end 114 to form a plane, and the second fixed end 114 is slightly adjacent to the disk surface 111, a recessed area formed in the plane.
  • the anchoring device 120 is a mesh structure woven by a nickel-titanium wire, the anchoring net 120 has a nest shape 122 (bowl shape), and the anchoring net 120 is a boneless structure, that is, an anchor. There is no skeleton provided inside the fixed net 120 for support.
  • the anchoring device 120 has a two-layer structure, and the central portion of the anchoring device 120 is folded toward the sealing disk 110 to form an inner edge portion.
  • the inner edge portion is a tapered mesh 121, and the tapered mesh 121 is near. After the end is retracted, a central end 126 is formed that is coupled to the sealing disk 110.
  • the tapered mesh 122 is distally open and rolled outwardly toward the proximal end to form an anchoring mesh 122.
  • the anchoring mesh 122 is at the periphery of the tapered mesh 121. In the present embodiment, the anchoring net 122 engages at the distal opening of the tapered mesh 122 through the arcuate transition zone 124.
  • the outer surface of the nested anchoring net 122 is evenly distributed with six barbs 127.
  • the anchoring mesh 122 encloses at least one-half of the axial length of the inner edge portion. In the present embodiment, the anchoring mesh 122 encloses the proximal end adjacent the inner edge portion, i.e., proximate the central end 126.
  • the nest-shaped nest end is bent inwardly to form a cuff region 123 (i.e., the end of the nest 122 near the sealing disk 110 extends radially toward the center end 126 to form a cuff region 123), and the center end 126 is located at the axial end of the conical mesh 121.
  • the portion of the cuff area 123 and the nest 122 is smoothly transitioned through the arc transition zone 125.
  • the second fixed end 114 of the sealing disk 110 and the central end 126 of the anchoring device 120 are welded together by a steel sleeve 130, combined into a left atrial appendage occluder 100 as shown in Figure 1.
  • the anchor net 120 is woven by 24 nickel-titanium wires, wherein 6 nickel-titanium wires are used for forming barbs, and the remaining 18 nickel-titanium wires are used for weaving the frame of the anchoring device, and barbed nickel-titanium wires. Same diameter as the frame nickel-titanium wire.
  • the nickel-titanium wire used to braid the frame of the anchoring device was previously molded into an inverted V shape, and a total of 18 inverted V-shaped nickel-titanium wires. As shown in FIG. 6a and FIG.
  • each of the nickel-titanium wires 1221 for forming the barbs is arranged in parallel with one side 1222 of one of the inverted V-shaped nickel-titanium wires of the anchoring device frame (the parallel arrangement may be performed as needed) Fixed or not fixed), and fixed by a steel sleeve (made of stainless steel) 1223, the steel sleeve 1223 is close to the apex 1224 where the two sides of the inverted V-shaped nickel-titanium wire intersect.
  • the distance from the apex 1224 of the nickel titanium wire is 8 mm.
  • the nickel-titanium wire After the nickel-titanium wire is prepared, all the nickel-titanium wires are first woven into a continuous cylindrical mesh tube 101. As shown in FIGS. 7a and 7b, the six nickel-titanium wires used for forming the barbs are evenly distributed along the circumference of the network tube 101. .
  • the tail end 1011 of the network tube 101 can be fixedly welded together by a stainless steel sleeve, and then the mesh tube is shaped into an anchoring device shape as shown in FIG. 3 by a mold and high temperature heating. At the same time, the end portion 1225 is partially opened outward at a certain angle, such as 30 degrees, to form a barb 127.
  • the barbs 127 are evenly distributed along the circumferential direction of the anchoring net, and the barbs 127 are radially outwardly turned along the anchoring net 122 and are axially inclined along the anchoring net 122. More intuitively, as shown in FIG. 7a and FIG. 7b, in the process of making the anchoring device 120, the nickel-titanium wire forming the barb 127 is arranged in parallel with the nickel-titanium wire of the anchoring device frame to form the nickel-titanium of the barb 127. The wire is lifted at the end to form a non-zero angle with the nickel titanium wire from which the anchoring device frame is made, as shown in Figure 3a.
  • the diameter of the nickel-titanium wire used to form the barb in this embodiment may also be larger than the diameter of the nickel-titanium wire of the frame of the anchoring device.
  • the number of barbs anchored on the net may also be three, nine, or other numbers of barbs evenly distributed.
  • the anchoring device frame can also be woven by using 36 or other numbers of inverted V-shaped nickel-titanium wires.
  • the steel sleeve 1223 for fixing the barbs 127 in this embodiment, and the steel sleeve for anchoring the tail end 1011 of the mesh tube 101 may also be made of a nickel-titanium sleeve or other metal sleeves conforming to biocompatibility requirements.
  • the nickel-titanium wire braided mesh tube 101 in this embodiment can also be shaped into a shape as shown in FIG. 9, and then the center end is welded and fixed to the shape shown in FIG.
  • the anchoring device as a whole has a boneless structure, so that the mechanical properties of each part of the anchoring device remain uniform.
  • the left atrial appendage occluder 100 can be inserted into a small diameter (such as an internal diameter of 9F) delivery device, and then into the superior vena cava through the femoral vein, then enter the right atrium, and then enter the left atrium through the interatrial septum.
  • a small diameter such as an internal diameter of 9F
  • the anchoring device 120 is released inside the left atrial appendage
  • the barbs 127 on the anchoring net 122 are hooked into the inner wall of the left atrial appendage; then the waist portion 112 of the sealing disk 110 is released in the left atrial appendage opening.
  • a is the left atrium
  • b is the left atrial appendage
  • c is the left ventricle
  • d is the right The ventricle
  • e is the right atrium.
  • the anchoring device 120 of the left atrial appendage occluder 100 is woven into a uniform mesh shape by using a nickel-titanium wire, and the nest-shaped anchoring net 122 of the outer layer of the anchoring device 120 can be evenly contacted with the inner wall of the left atrial appendage to ensure uniformity.
  • the pressure is evenly applied to the inner wall of the left atrial appendage without local stress concentration.
  • the barbs 127 on the anchor net 122 of the left atrial appendage occluder 100 are made of nickel-titanium wire, and the diameter of the barbs 127 is relatively thin, so that the phenomenon of perforation of the inner wall of the left atrial appendage is not easily generated.
  • the sealing disc 110 of the left atrial appendage occluder 100 has both the waist portion 112 and the disc surface 111.
  • the waist portion 112 and the disc surface 111 can both block the opening of the left atrial appendage, and the double sealing effect improves the left atrial appendage.
  • the blocking function of the occluder 100 as a whole.
  • the left atrial appendage occluder 100 in this embodiment is capable of achieving repeated release.
  • the release process is as shown in FIG. 21a, FIG. 21b and FIG. 21c.
  • the anchoring device is in a compressed state in the delivery device, and the delivery device is moved to the opening of the left atrial appendage.
  • the anchoring device is gradually released from the conveying device.
  • the anchoring device adopts superelastic metal wire or memory alloy wire
  • the outer anchoring mesh closing area is separated from the conveying device, and then the self-rewinding is performed, so that the contact with the left atrial appendage wall is always For a smooth surface, after the anchoring device is released, the barb penetrates into the wall of the left atrial appendage, and the direction of the barb is directed toward the opening of the left atrial appendage.
  • the left atrial appendage occluder needs to be recovered.
  • the recovery process is shown in Figure 22a, Figure 22b and Figure 22c.
  • the thorn is first completely withdrawn from the inner wall of the left atrial appendage from the direction of penetration, and then, together with the outer anchoring net, is transported into the delivery device under the traction of the delivery device.
  • b is a left atrial appendage.
  • This embodiment differs from Embodiment 1 in that each of the nickel-titanium wires 2221 for forming the barbs and one of the inverted V-shaped nickel-titanium wires 2222 of the anchor mesh frame are joined by welding, the welded region
  • the length of 2223 is 2 mm
  • the weld zone 2223 is adjacent to the apex 2224 where the two sides of the inverted V-shaped nickel-titanium wire intersect.
  • the distance is 8 mm, as shown in Figures 11a, 11b, 12a, and 12b.
  • each of the nickel-titanium wires 3221 for forming the barbs is 5 mm
  • the nickel-titanium wire 3221 is divided into a fixed section and a free section, and the fixed section passes through the steel sleeve 3223 and
  • Embodiment 1 differs from Embodiment 1 in that the anchoring device 420 does not include a cuffing region and includes only a central end 426 that is coupled to the sealing disk, and a conical mesh 421 that is diffused away from the sealing disk by the central end 426.
  • the nested anchoring net 422 around the conical mesh 421, the conical mesh 421 and the nested anchoring net 422 are smoothly connected by a circular arc transition zone 424, and six barbs 427 are evenly distributed on the surface of the nested shape 422, such as Figure 15a, Figure 15b.
  • the anchoring device 520 includes a center end 526 connected to the sealing disk, a conical mesh 521 diffused away from the sealing disk by the center end 526, and a truncated-shaped anchoring net 522 located at the periphery of the conical mesh 521.
  • the net 521 and the truncated anchor net 522 are smoothly connected by a circular arc transition region 524, and six barbs 527 are uniformly distributed on the surface of the truncated cone shape 522.
  • the center end 526 is located at the axial end of the conical mesh 521, and the end of the truncated anchoring net 522 adjacent to the sealing disc is connected with a cuffing region 523 extending radially toward the central end 526, and the cuff region 523 and the truncated cone shape 522 pass through the circle.
  • the arc transition zone 525 is smoothly transitioned.
  • the outer anchoring net structure of the anchoring device 520 is a truncated cone shape 522, as shown in Figs. 16a and 16b.
  • the anchoring device 620 includes a central end 626 that is coupled to the sealing disk, a conical mesh 621 that is diffused away from the sealing disk by the central end 626, and a curved toroidal anchoring mesh 622 located at the periphery of the conical mesh 621.
  • the arcuate mesh 621 and the curved toroidal anchoring mesh 622 pass through the arc transition zone 624.
  • the sleek connection is evenly distributed with six barbs 627 on the surface of the curved surface 622.
  • the central end 626 is located at the axial end of the tapered mesh 621, and the end of the curved toroidal anchoring net 622 adjacent to the sealing disk is connected with a cuffing region 623 extending radially toward the central end 626, the cuffing region 623 and the curved circular anchor
  • the fixed nets 622 are smoothly connected by a circular transition zone 625.
  • the anchoring device 620 has an outer surface anchoring net structure of a curved circular ring 622, as shown in Figs. 17a and 17b.
  • sealing disk 710 is composed only of the disk surface 711, and the first fixed end 713 and the second fixed end 714 are respectively disposed on two sides of the disk surface 711; Layer PET barrier film 715, as shown in FIG.
  • the disk surface 711 is a second fixed end 714 and the center end of the anchor net 720 is joined together by a steel sleeve, as shown in FIG.
  • FIG. 20 The schematic diagram of the left atrial appendage occluder 700 provided in the present embodiment is shown in FIG. 20, in which, a is the left atrium, b is the left atrial appendage, c is the left ventricle, and d is the right ventricle, e For the right atrium.

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Abstract

一种左心耳封堵器（100），包括相互连接的密封盘（110）和锚定装置（120），所述锚定装置（120）与左心耳相配合的部位为锚定网，且该锚定网为无骨结构。锚定装置（120）整体为无骨结构。所述锚定装置（120）由超弹性金属丝或记忆合金金属丝编织而成，且远端呈开口状，锚定装置（120）近端收束与密封盘（110）连接呈锥形网，锚定装置（120）远端开口并向近端翻卷形成所述锚定网，且锚定网包围所述锥形网。锚定网通过圆弧过渡区与锥形网衔接。该左心耳封堵器（100）能够力量均布地锚定在左心耳内部，消除局部应力集中，并能够实现可重复释放，以及有效可靠地封堵左心耳开口部位。

Description

一种左心耳封堵器 技术领域
本发明涉及医疗器械技术领域，具体涉及一种左心耳封堵器。
背景技术
心房颤动(简称房颤)是最常见的持续性心律失常，随着年龄的增长，房颤发生率不断增加，75岁以上人群可达10％。
房颤时心房激动的频率达300-600次/分，心跳频率往往快而且不规则，心房失去有效的收缩功能。房颤时左心耳收缩力下降，再加上左心耳自身的形态特点及左心耳内的肌小梁凸凹不平，使得左心耳内血流产生漩涡和流速减慢，促使血栓形成。非瓣膜病房颤患者左心房血栓90％以上存在于左心耳，血栓脱落后会通过主动脉血管进入脑部动脉血管形成脑栓塞，即脑卒中。
针对房颤患者脑卒中的风险，临床上目前主要采用三种方法进行预防治疗，即抗凝药物治疗、外科手术治疗和经皮左心耳封堵治疗。
抗凝药物治疗是指通过服用抗凝药物(如华法林，阿司匹林)来抑制血液凝固，以降低左心耳内血栓形成的风险，进而减少脑卒中的发生概率。临床试验表明抗凝药物治疗可显著降低脑卒中的发生概率，但是抗凝药物治疗是一个漫长的过程，同时也存在明显的并发症，主要表现为出血并发症，并且可能出现较严重的情况。
外科手术治疗包括外科手术切除或者缝合左心耳，但是外科手术创伤大，一般是在进行瓣膜置换或者冠状动脉搭桥等其他手术时完成，患者一般难以接受单纯的左心耳外科手术，特别是高龄患者。
经皮左心耳封堵治疗是指通过经皮穿刺的方式，利用一直径较小的输送鞘管，将一左心耳封堵器输送到位于心脏左心房的左心耳并释放。左心耳封堵器可将左心耳的开口位置封堵，心房内血流不能进入左心耳，因此 不能形成血栓，从而达到预防心房颤动诱发血栓栓塞的目的。从2001年开始，经皮左心耳封堵治疗开始投入使用，先后进行了动物实验和临床试验。临床试验表明，左心耳封堵术可有效降低房颤患者脑卒中的发生概率。
近几年经皮左心耳封堵术得到了很好的推广应用，全球内不同的厂家也陆续推出了新的产品。目前左心耳封堵器基本都采用镍钛合金加高分子材料覆膜制成，镍钛合金主要起到固定的作用，高分子材料覆膜主要起到封堵血流的作用。
从设计结构上来看，左心耳封堵器主要分为两种类型。第一种是一个塞子的结构，直接放入左心耳内部，塞子上带有倒刺用于固定，这种结构的左心耳封堵器通常需要输送鞘管深入左心耳内部较深的位置，因此容易刺穿左心耳，且不可重复释放。
第二种是由一个封堵盘和一个锚定盘组成的结构，封堵盘在左心房内封堵左心耳开口位置，锚定盘是放在左心耳内部且带有倒刺，起到固定封堵盘的作用。第二种结构的左心耳封堵器主要是靠封堵盘封堵左心耳，释放时必须要保证封堵盘可靠的贴合密封在左心耳开口位置。如果释放后封堵盘不能贴合在左心耳开口位置，且锚定盘不能被重新收回鞘管，那么会导致手术失败，并且可能会进一步增加血栓形成的风险，因此锚定盘的可重复释放非常重要。
现有技术中，也存在能够实现重复释放的锚定盘，但是整个锚定盘并不是力量均布的固定在左心耳内部，而是通过几个局部的区域进行固定，这样会导致这几个区域的应力集中，并且这几个区域的倒刺也会有刺穿左心耳壁，进而导致心包积液等并发症的风险。
发明内容
本发明提供了一种左心耳封堵器，能够均匀地贴附在左心耳内壁上，并能够实现重复释放。
一种左心耳封堵器，包括相互连接的密封盘和锚定装置，所述锚定装置与左心耳相配合的部位为锚定网，且该锚定网为无骨结构。
本发明提供的左心耳封堵器利用经皮穿刺的方式通过输送导管输送 到心脏左心耳的位置，所述的锚定装置用于锚定整个左心耳封堵器，密封盘将左心耳的开口位置封堵，阻挡左心房内血流入左心耳，以预防房颤患者在左心耳内形成血栓，进而导致脑卒中。
所述锚定网为网状，且采用无骨结构，能够均匀地贴附在左心耳的内壁上，实现封堵器在左心耳开口部位的位置固定，同时，该锚定网在密封盘位置不当，不能完全贴合在左心耳开口处实现封堵时，能够重新回收入输送器械，实现重复释放，显著提高手术的成功率。
相比现有技术中的锚定装置结构而言，锚定网与左心耳之间为面接触，将锚定力均匀分布在锚定网与左心耳的接触面上，消除局部应力集中的现象，降低左心耳壁刺穿的风险。
作为优选，所述锚定装置具有由内至外的翻卷结构，翻卷结构的内缘部分与密封盘连接，翻卷结构的外围部分为与左心耳相配合的锚定网。
也即所述锚定装置为内外双层结构，锚定网位于内缘部分的外围。
作为优选，所述锚定网包围内缘部分轴向长度的至少二分之一。
作为优选，所述锚定网翻卷包围至邻近内缘部分的近端。
锚定网在翻卷时应有足够长的延伸路径，以及翻卷角度，作为进一步的优选，以锚定装置的轴线为基准，翻卷结构的翻卷角度大于等于180度，作为进一步的优选翻卷角度大于等于270度。
作为优选，所述内缘部分的近端收束与密封盘连接。
近端收束是指内缘部分在靠近密封盘一侧逐渐收拢汇聚，继而连接在密封盘上，优选连接在密封盘径向的中心区域。
具体连接方式可以是不可分离的固定连接，例如一体结构，或焊接等，也可以采用可拆卸连接，例如采用卡扣、螺纹或过渡的连接件等方式。
作为优选，所述内缘部分为可压缩镂空结构。至少满足径向上可以压缩，以便于通过血管置入。
作为进一步的优选，所述内缘部分为网状结构或多根连杆结构。作为优选，锚定装置整体为无骨结构。本发明中的锚定装置不存在骨架结构，当锚定装置植入左心耳中，与左心耳内壁相互作用时，力量分布均匀，尤其是锚定网没有骨架结构，使锚定网与左心耳内壁的接触面上，力量分布 均匀，无骨结构也保证锚定装置具有很好的顺应性，易于适合不同的左心耳内部解剖结构。
本发明中的无骨结构是指，在锚定装置或锚定网中没有设置具有支撑作用的骨架结构，进而使锚定装置或锚定网各个部位的力学性能保持均一，不会出现应力集中在骨架结构上。
现有技术中在锚定装置中设置骨架结构，当骨架结构与左心耳内壁相互贴合时，左心耳与锚定装置之间的相互作用力集中于骨架结构上，容易使左心耳内壁局部受力过大产生应力集中，进而有刺穿左心耳的风险。
可选的，所述锚定网由金属丝编织而成或金属管切割而成。
锚定网是锚定装置中与左心耳内腔接触配合的部位，锚定装置中的其他部位，例如翻卷结构的内缘部分其加工方式与锚定网部分可以相同也可以不相同，相同作为优选，即所述锚定装置由金属丝编织而成或金属管切割而成。
作为优选，所述锚定装置采用至少一根金属丝编织而成，所述金属丝为超弹性金属丝或记忆合金金属丝。所述锚定网呈巢形(即碗形)。为了保证与人体具有良好的生物相容性，并满足力学性能的需要，所述的超弹性金属丝或记忆合金金属丝采用镍钛丝。
所述锚定网具有规律分布的单元格结构。各单元格采用菱形或近似菱形的结构，所述锚定网为旋转曲面，旋转曲面上任意纬圆与锚定网的单元格的交点沿旋转轴均匀分布。
作为优选，所述内缘部分的远端开口并朝近端向外翻卷形成所述锚定网，且锚定网包围内缘部分。本发明中的远端和近端是相对于操作者而言，封堵器中距离操作者更近的一端为近端，远离操作者的一端为远端。
作为优选，锚定网通过圆弧过渡区与内缘部分的远端衔接。
锚定网与内缘部分之间通过圆弧过渡区圆滑过渡，不存在尖锐部。
作为优选，所述内缘部分呈圆锥形，棱锥形，圆台形、棱台形、圆柱形、腰鼓形或波纹管状。
内缘部分在靠近密封盘一侧的收束(收拢)趋势可以有多种，内缘部分整体上收拢趋势均匀变化时，内缘部分整体上会呈锥形。
若为圆台形、棱台形、圆柱形、腰鼓形或波纹管状时，可视为内缘部分仅在靠近密封盘一侧的很小区域进行收束，远离密封盘的部位占绝大部分并决定了内缘部分的整体形状。
内缘部分为网状结构时内缘部分即为锥形网，锚定网和锥形网形成内外两层结构，锚定网位于锥形网的外围，锥形网的一端为与密封盘相连的中心端，锚定网通过圆弧过渡区衔接在锥形网的底缘(内缘部分的远端)。
锚定网为旋转曲面，旋转曲面的母线为直线或弧线。
当母线为弧线时，弧线的开口朝向锚定网的内部，锚定网呈曲面环形，曲面环形与圆弧过渡区圆滑衔接。
当母线为直线，且与轴线平行时，锚定网呈巢形，巢形与圆弧过渡区圆滑衔接。
当母线为直线，且与轴线倾斜时，锚定网呈圆台形，圆台形的下底(面积较大的底)靠近密封盘布置，圆台形的上底与圆弧过渡区圆滑衔接。
锚定装置由超弹性金属丝或记忆合金金属丝编织而成，优选地，巢形锚定网的巢口端向内弯折形成收口区。
所述收口区朝向中心端径向弯折，通过收口区使超弹性金属丝或记忆合金金属丝的端点隐藏在锚定网的内部，降低与左心耳内壁直接接触的可能性，从而减少对左心耳的伤害，锚定网的各部位之间均为圆滑过渡，不存在尖锐部。
本发明提供的封堵器释放时，收口区最先由输送器械中释放，由于采用超弹性金属丝或记忆合金金属丝编织而成，收口区在脱离输送器械之后，即自行发生翻转卷曲，使锚定装置与左心耳接触的部位始终为圆弧过渡的部位，避免对左心耳造成损伤。
为了使锚定网能够可靠地固定在左心耳内，优选地，所述锚定网上设有多根倒刺，当锚定网处于轴向拉伸压缩状态时，倒刺设置于锚定网的内侧面。所述倒刺沿锚定网的超弹性金属丝或者记忆合金金属丝的周向倾斜。即所述倒刺沿锚定网径向外翻，且所述倒刺沿锚定网轴向倾斜。
本发明提供的倒刺结构能够保证封堵器的重复释放，在人体内释放时，倒刺能够有效地刺入左心耳内壁，锚定封堵器的位置，如果密封盘的 位置不合适，不能很好的封堵左心耳开口位置，需要将封堵器收回重新释放，在收回的过程中，由于倒刺处在锚定网上，即处在外层，当牵引中心端实现回收时，内层进入输送器械，外层与内层的运动方向相反，当双层结构消失时，外层也收入输送器械中，由于倒刺处在外层，倒刺的运动方向首先与刺入方向相反，使倒刺能够顺利的由左心耳内壁中抽出，然后再沿着牵引方向回收入输送器械中。
所述倒刺设置在圆弧过渡区、锚定网、或收口区的至少一处。所述倒刺与锚定网上的金属丝通过套箍固定，或焊接固定。
所述倒刺由一根超弹性金属丝或记忆合金金属丝制成，为与锚定网的超弹性金属丝或记忆合金金属丝相区别，称为倒刺金属丝，倒刺金属丝可以采用镍钛丝。所述套箍可以采用金属材质。
作为倒刺的第一种实施方式，所述倒刺的根部沿所依附的金属丝延伸至锚定装置近端(例如内层锥形网中心端)。即倒刺金属丝的一端与锚定网的中心端固定，并与锚定网上的一根超弹性金属丝或记忆合金金属丝相互贴靠并行，在接近倒刺金属丝的另一端处，利用套箍(例如钢套)，或焊接将倒刺金属丝和并行的超弹性金属丝或记忆合金金属丝进行固定，倒刺金属丝的末端延伸出固定点1～5mm，并向锚定网的外部张开一定角度，形成所述的倒刺。
作为倒刺的第二种实施方式，倒刺金属丝的一端处在套箍内部，另一端延伸出套箍1～5mm，形成所述的倒刺。
作为倒刺的第三种实施方式，倒刺金属丝的一端与编织锚定网的至少一根超弹性金属丝或记忆合金金属丝焊接固定，另一端延伸出套箍1～5mm，形成所述的倒刺。
在倒刺的第二种实施方式和第三种实施方式中，倒刺金属丝的长度较短，一般不超过10mm。
现有技术中仅在密封盘内设置一层阻流膜，封堵效果有限，为了保证密封盘具有良好的封堵效果，优选地，所述密封盘内设有至少两张阻流膜。所述阻流膜采用柔韧性良好的PET、PTFE等医用高分子材料制成。
所述密封盘采用至少一根超弹性金属丝或记忆合金金属丝编织而成。 所述超弹性金属丝或记忆合金金属丝可以采用镍钛丝。
所述密封盘为网状结构。所述密封盘包括相互连接的盘面和腰部：
所述盘面处在远离锚定网的一侧，盘面的中心设有用于连接输送器械的第一固定端；
所述腰部处在靠近锚定网的一侧，腰部的中心设有用于连接锚定网的第二固定端。
现有技术中由于仅设置一层阻流膜，因此，只具有盘面，将阻流膜置于盘面内，本发明中为了设置多层阻流膜，同时保证多层阻流膜之间相互没有干涉，且阻流效果能够相互配合，显著改善阻流效果，对密封盘进行了结构改进，增加了能够容置多层阻流膜的腰部。
作为优选，所述腰部包括：
由第二固定端向外辐射的扩散段；
处在扩散段外围呈筒状的本体段，该本体段的顶缘与盘面连接，本体段的底缘与扩散段的外缘连接。
所述的扩散段由第二固定端向外辐射扩散，形成一平面或者一圆锥面，第二固定端还可略向盘面靠近。
本体段为旋转曲面，本体段的外周等于或大于锚定网的外周。所述本体段的顶缘和盘面圆滑连接，所述本体段的底缘与扩散段的外缘之间圆弧过渡。
作为优选，所述阻流膜为两张，一张设置在盘面上，另一张位于腰部的本体段内或扩散段上。
盘面沿轴向的长度较小，阻流膜位于盘面内，腰部本体段沿轴向的长度较长，阻流膜可位于腰部本体段的内部，或处在扩散段上。
为了达到更好的阻流效果，优选地，所述阻流膜为三张，一张设置在盘面上，一张位于腰部的本体段内，一张位于扩散段上。
本发明提供的左心耳封堵器，能够力量均布地锚定在左心耳内部，消除局部应力集中，并能够实现可重复释放，以及有效可靠地封堵左心耳开口部位。
附图说明
图1为实施例1左心耳封堵器的整体示意图；
图2为实施例1左心耳封堵器中密封盘的示意图；
图3a为实施例1左心耳封堵器中锚定装置的示意图；
图3b为实施例1左心耳封堵器中锚定装置的示意图(另一角度)；
图4为实施例1中连接密封盘和锚定装置的钢套的示意图；
图5为实施例1中编织锚定装置框架的镍钛丝的结构示意图；
图6a为实施例1中用作倒刺的镍钛丝与编织锚定装置框架的镍钛丝的连接示意图；
图6b为图6a中的A部放大图；
图7a为实施例1中制作锚定装置过程中编织的网管的示意图；
图7b为图7a中的B部放大图；
图8为实施例1中编织的网管的一端收拢焊接后的示意图；
图9为实施例1中锚定装置的中心端没有添加钢套焊接的示意图；
图10为实施例1左心耳封堵器在左心耳内释放后的示意图；
图11a为实施例2中用作倒刺的镍钛丝与编织锚定装置框架的镍钛丝的连接示意图；
图11b为图11a中的C部放大图；
图12a为实施例2左心耳封堵器的示意图；
图12b为图12a中的D部放大图；
图13a为实施例3中用作倒刺的镍钛丝与编织锚定装置框架的镍钛丝的连接示意图；
图13b为图13a中的E部放大图；
图14a为实施例3左心耳封堵器的示意图；
图14b为图14a中的F部放大图；
图15a为实施例4中锚定装置的示意图；
图15b为实施例4中锚定装置的示意图(另一角度)；
图16a为实施例5中锚定装置的示意图；
图16b为实施例5中锚定装置的示意图(另一角度)；
图17a为实施例6中锚定装置的示意图；
图17b为实施例6中锚定装置的示意图(另一角度)；
图18为实施例7中密封盘的示意图；
图19为实施例7左心耳封堵器的整体示意图；
图20为实施例7左心耳封堵器在左心耳内释放后的示意图；
图21a为实施例1中准备释放锚定网的示意图；
图21b为实施例1中释放锚定网收口区的示意图；
图21c为实施例1中锚定装置释放完毕的示意图；
图22a为实施例1中密封盘回收完成，准备回收锚定装置的示意图；
图22b为实施例1中锚定装置部分回收的示意图；
图22c为实施例1中回收锚定装置，倒刺完全从左心耳壁中撤出的示意图。
具体实施方式
下面结合附图和实施例，对本发明进行详细说明。
实施例1
如图1所示，本发明提供的左心耳封堵器100由密封盘110和锚定装置120组成。
密封盘110为采用镍钛丝编织而成的网状结构，如图2所示，密封盘110由盘面111和腰部112组成，在盘面的中心设有第一固定端113，腰部112的中心设有第二固定端114，盘面内缝有1层PET阻流膜115，腰部112内缝有至少1层阻流膜116。
第一固定端113用于与输送器械相连，第二固定端114与锚定装置120相连。
如图2所示，腰部112包括由第二固定端114向外辐射的扩散段117、处在扩散段117外围呈筒状的本体段118，本体段118的顶缘与盘面111连接，本体段118的底缘与扩散段117的外缘之间通过圆弧119过渡连接，腰部112内的阻流膜116位于本体段118轴向的中部。
扩散段117由第二固定端114向外辐射扩散，形成一平面，第二固定端 114略向盘面111靠近，在该平面内形成的凹陷区。
如图3a、图3b所示，锚定装置120采用镍钛丝编织而成的网状结构，锚定网120呈巢形122(碗形)，且锚定网120为无骨结构，即锚定网120内部没有设置骨架用于支撑。
本实施例中锚定装置120为双层结构，锚定装置120中部朝密封盘110方向收拢延伸形成内缘部分，在本实施例中内缘部分为锥形网121，锥形网121的近端收缩后，形成与密封盘110相连的中心端126。锥形网122远端开口并朝近端向外翻卷形成锚定网122锚定网122处在锥形网121的外围。在本实施例中，锚定网122通过圆弧过渡区124衔接在锥形网122的远端开口处。巢形锚定网122的外表面均匀分布6个倒刺127。锚定网122包围内缘部分轴向长度的至少二分之一，在本实施例中，锚定网122包围至邻近内缘部分的近端，即接近中心端126。
巢形的巢口端向内弯折形成收口区123(即巢形122靠近密封盘110的一端向中心端126径向延伸形成收口区123)，中心端126位于锥形网121的轴向端部，收口区123与巢形122之间通过圆弧过渡区125圆滑过渡连接。
如图4所示，密封盘110的第二固定端114和锚定装置120的中心端126通过钢套130焊接在一起，组合成如图1所示的左心耳封堵器100。
本实施例中锚定网120采用24根镍钛丝编织而成，其中6根镍钛丝用于形成倒刺，其余18根镍钛丝用于锚定装置框架的编织，倒刺镍钛丝和框架镍钛丝的直径相同。
如图5所示，用于编织锚定装置框架的镍钛丝预先塑型成倒V字的形状，一共有18根倒V字的镍钛丝。如图6a、图6b所示，用于形成倒刺的每根镍钛丝1221与锚定装置框架的其中1根倒V字形镍钛丝的1边1222并行排列(并行排列时可以根据需要进行固定或不固定)，并通过一个钢套(采用不锈钢材质)1223压紧固定，钢套1223靠近倒V字形镍钛丝两边相交的顶点1224。
如图6b所示，镍钛丝1221延伸出钢套1223的端部1225形成倒刺127，端部1225的长度为2mm(即图中H1＝2mm)，端部1225的端点1226距离倒V形镍钛丝的顶点1224的距离为8mm。
镍钛丝准备完成后，将所有的镍钛丝首先编织定型成一直筒形的网管101，如图7a、图7b所示，用于形成倒刺的6根镍钛丝沿网管101的圆周均匀分布。网管101制作完成后，如图8所示，可先将网管101的尾端1011用不锈钢套固定焊接在一起，然后，通过模具和高温加热将网管定型成如图3所示的锚定装置形状，并同时将端部1225部分向外张开一定的角度，如30度，形成倒刺127。
如图1所示，本实施例中，倒刺127沿锚定网的周向均匀分布，且倒刺127沿锚定网122径向外翻，并沿锚定网122轴向倾斜。更直观地示意如图7a、图7b所示，在制作锚定装置120的过程中，形成倒刺127的镍钛丝与锚定装置框架的镍钛丝并行排列，形成倒刺127的镍钛丝在末端翘起，与制作锚定装置框架的镍钛丝形成一个不为零的角度，图3a所示。
本实施例用于形成倒刺的镍钛丝直径也可大于锚定装置框架的镍钛丝直径。本实施例中锚定网上的倒刺数量，也可为均匀分布的3个、9个，或其它数量的倒刺。本实施例中锚定装置框架也可采用36根或者其它数量倒V形镍钛丝进行编织。
本实施例中用于固定倒刺127的钢套1223，以及锚定网管101的尾端1011的钢套也可采用镍钛套或者其他符合生物相容性要求的金属套。
本实施例中的镍钛丝编织的网管101制作完成后，也可先将其定型成如图9所示的形状，然后，再将中心端用金属套焊接固定成图3所示的形状。制作完成后，锚定装置整体为无骨结构，使得锚定装置各个部位的力学性能保持均一。
本实施例中左心耳封堵器100可装入一直径较小(如内径9F)的输送器械中，然后通过股静脉穿刺进入上腔静脉，接着进入右心房，再通过房间隔穿刺进入左心房。左心耳封堵器100释放时，首先，将锚定装置120释放在左心耳内部，锚定网122上的倒刺127钩入左心耳内壁；然后将密封盘110的腰部112释放在左心耳开口位置，密封盘110的盘面111释放在左心房开口位置处，将左心耳开口位置封闭。释放完成后，将左心耳封堵器从输送器械连接处解脱，最后释放完成的图片如图10所示，图10中，a为左心房，b为左心耳，c为左心室，d为右心室，e为右心房。
本实施例中左心耳封堵器100的锚定装置120采用镍钛丝编织成均匀的网格形状，锚定装置120外层的巢形锚定网122可与左心耳内壁均匀接触，以保证压力均匀施加到左心耳内壁上，而不会产生局部应力集中的现象。
本实施例中左心耳封堵器100的锚定网122上的倒刺127采用镍钛丝制成，倒刺127的直径相对较细，因此不容易产生左心耳内壁穿孔的现象。
本实施例中左心耳封堵器100的密封盘110同时有腰部112和盘面111，腰部112和盘面111都能起到封堵左心耳开口的作用，这样的双重封堵效果改善了该左心耳封堵器100整体的封堵作用。
本实施例中的左心耳封堵器100能够实现重复释放，释放过程如图21a图21b、图21c所示，锚定装置在输送器械中处于压缩状态，输送器械移动至左心耳的开口处，锚定装置由输送器械中逐步释放，由于锚定装置采用超弹性金属丝或记忆合金金属丝，外层锚定网收口区脱离输送器械后，即自行翻卷，使得与左心耳壁接触的部位始终为圆滑的表面，锚定装置释放完毕后，倒刺刺入左心耳壁中，倒刺的刺入方向朝向左心耳的开口处。
若左心耳封堵器的位置释放不当，不能起到很好的密封效果，则需要对左心耳封堵器进行回收，回收过程如图22a、图22b、图22c所示，在回收时，倒刺首先背离刺入方向由左心耳内壁中完全抽出，然后在输送器械的牵引下，与外层锚定网共同收入输送器械中。
图21a～图22c中，b为左心耳。
实施例2
本实施例与实施例1的不同之处在于，用于形成倒刺的每根镍钛丝2221与锚定网框架中的其中1条倒V形镍钛丝2222通过焊接连接在一起，焊接区域2223的长度为2mm，焊接区域2223靠近倒V字形镍钛丝两边相交的顶点2224。镍钛丝2221延伸出焊接区域2223的端部2225形成倒刺227，端部2225的长度为2mm(图11b中H2＝2mm)，端部2225的端点2226距离倒V形镍钛丝的顶点2224的距离为8mm，如图11a、图11b、图12a、图12b所示。
实施例3
本实施例与实施例1的不同之处在于，用于形成倒刺的每根镍钛丝3221的总长度为5mm，镍钛丝3221分为固定段和自由段，固定段通过钢套3223与锚定装置框架镍钛丝3222连接在一起，固定段的长度为3mm，且固定段完全位于钢套3223内部；自由段3225伸出钢套3223的外部，形成倒刺327，自由段3225的长度为2mm(即图13b中H3＝2mm)，自由段3225的端点3226距离倒V形镍钛丝的顶点3224的距离为8mm，如图13a、图13b、图14a、图14b所示。
实施例4
本实施例与实施例1的不同之处在于，锚定装置420不包括收口区，只包括与密封盘相连的中心端426，由中心端426朝远离密封盘方向扩散的锥形网421，位于锥形网421外围的巢形锚定网422，锥形网421和巢形锚定网422之间通过圆弧过渡区424圆滑连接，在巢形422的表面均匀分布6个倒刺427，如图15a、图15b所示。
实施例5
本实施例中，锚定装置520包括与密封盘相连的中心端526，由中心端526朝远离密封盘方向扩散的锥形网521，位于锥形网521外围的圆台形锚定网522，锥形网521和圆台形锚定网522之间通过圆弧过渡区524圆滑连接，在圆台形522的表面均匀分布6个倒刺527。
中心端526位于锥形网521的轴向端部，圆台形锚定网522靠近密封盘的一端连接有向中心端526径向延伸的收口区523，收口区523与圆台形522之间通过圆弧过渡区525圆滑过渡连接。
本实施例与实施例1的不同之处在于，锚定装置520外层锚定网结构为圆台形522，如图16a、图16b所示。
实施例6
本实施例中，锚定装置620包括与密封盘相连的中心端626，由中心端626朝远离密封盘方向扩散的锥形网621，位于锥形网621外围的曲面圆环形锚定网622，锥形网621和曲面圆环形锚定网622之间通过圆弧过渡区624 圆滑连接，在曲面圆环形622的表面均匀分布6个倒刺627。
中心端626位于锥形网621的轴向端部，曲面圆环形锚定网622靠近密封盘的一端连接有向中心端626径向延伸的收口区623，收口区623与曲面圆环形锚定网622之间通过圆弧过渡区625圆滑过渡连接。
本实施例与实施例1的不同之处在于，锚定装置620外层锚定网结构为曲面圆环形622，如图17a、图17b所示。
实施例7
本实施例与实施例1的不同之处在于，密封盘710仅由盘面711组成，在盘面711的两侧分别设有第一固定端713，和第二固定端714；盘面711内缝有1层PET阻流膜715，如图18所示。
盘面711是第二固定端714和锚定网720的中心端通过钢套连接在一起，如图19所示。
本实施例提供的左心耳封堵器700释放后在左心耳内的示意图如图20所示，图20中，a为左心房，b为左心耳，c为左心室，d为右心室，e为右心房。

Claims (21)

  1. 一种左心耳封堵器，包括相互连接的密封盘和锚定装置，其特征在于，所述锚定装置与左心耳相配合的部位为锚定网，且该锚定网为无骨结构。
  2. 如权利要求1所述的左心耳封堵器，其特征在于，所述锚定装置具有由内至外的翻卷结构，翻卷结构的内缘部分与密封盘连接，翻卷结构的外围部分为与左心耳相配合的锚定网。
  3. 如权利要求2所述的左心耳封堵器，其特征在于，所述内缘部分的近端收束与密封盘连接。
  4. 如权利要求2所述的左心耳封堵器，其特征在于，所述内缘部分为可压缩镂空结构。
  5. 如权利要求4所述的左心耳封堵器，其特征在于，所述内缘部分为网状结构或多根连杆结构。
  6. 如权利要求3所述的左心耳封堵器，其特征在于，所述内缘部分整体上呈圆锥形、棱锥形、圆台形、棱台形、圆柱形、腰鼓形或波纹管状。
  7. 如权利要求2所述的左心耳封堵器，其特征在于，所述内缘部分的远端开口并朝近端向外翻卷形成所述锚定网，且锚定网包围内缘部分。
  8. 如权利要求7所述的左心耳封堵器，其特征在于，所述锚定网包围内缘部分轴向长度的至少二分之一。
  9. 如权利要求8所述的左心耳封堵器，其特征在于，所述锚定网翻卷包围至邻近内缘部分的近端。
  10. 如权利要求7所述的左心耳封堵器，其特征在于，锚定网通过圆弧过渡区与内缘部分的远端衔接。
  11. 如权利要求2所述的左心耳封堵器，其特征在于，所述锚定装置整体呈网状结构。
  12. 如权利要求11所述的左心耳封堵器，其特征在于，所述锚定装置采用至少一根金属丝编织而成，所述金属丝为超弹性金属丝或记忆合金金属丝。
  13. 如权利要求1或2所述的左心耳封堵器，其特征在于，所述锚定网呈巢形。
  14. 如权利要求13所述的左心耳封堵器，其特征在于，巢形锚定网的巢口端向内弯折形成收口区。
  15. 如权利要求1～12任一项所述的左心耳封堵器，其特征在于，所述锚定网上设有多根倒刺，当锚定网处于轴向拉伸压缩状态时，倒刺设置于锚定网的内侧面。
  16. 如权利要求15所述的左心耳封堵器，其特征在于，所述倒刺与锚定网上的金属丝通过套箍固定，或焊接固定。
  17. 如权利要求15所述的左心耳封堵器，其特征在于，所述倒刺的根部沿所依附的金属丝延伸至锚定装置近端。
  18. 如权利要求15所述的左心耳封堵器，其特征在于，所述倒刺设置在圆弧过渡区、锚定网、或收口区的至少一处。
  19. 如权利要求1或2所述的左心耳封堵器，其特征在于，锚定装置整体为无骨结构。
  20. 如权利要求1～12任一项所述的左心耳封堵器，其特征在于，所述锚定网由金属丝编织而成或金属管切割而成。
  21. 如权利要求1～12任一项所述的左心耳封堵器，其特征在于，所述锚定装置由金属丝编织而成或金属管切割而成。
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