WO2015135369A1 - 左心耳封堵器及其制作方法 - Google Patents

左心耳封堵器及其制作方法 Download PDF

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Publication number
WO2015135369A1
WO2015135369A1 PCT/CN2014/095889 CN2014095889W WO2015135369A1 WO 2015135369 A1 WO2015135369 A1 WO 2015135369A1 CN 2014095889 W CN2014095889 W CN 2014095889W WO 2015135369 A1 WO2015135369 A1 WO 2015135369A1
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WIPO (PCT)
Prior art keywords
atrial appendage
left atrial
disk surface
blank
appendage occluder
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PCT/CN2014/095889
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English (en)
French (fr)
Inventor
吴弘
周而辰
朱玉峰
杨永森
秦永文
陈娟
储国俊
Original Assignee
上海形状记忆合金材料有限公司
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Application filed by 上海形状记忆合金材料有限公司 filed Critical 上海形状记忆合金材料有限公司
Priority to EP14885134.8A priority Critical patent/EP3146915A4/en
Publication of WO2015135369A1 publication Critical patent/WO2015135369A1/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
    • 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
    • A61B17/12027—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
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • 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
    • 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
    • A61B2017/12127—Double occlusion, e.g. for creating blood-free anastomosis site

Definitions

  • the invention relates to a cardiac surgery medical device, in particular to a left atrial appendage occluder and a manufacturing method thereof.
  • Atrial fibrillation is one of the most common arrhythmias in the clinic.
  • the incidence rate of the population is about 0.89%.
  • the incidence rate increases with age, and the population over 75 years old can reach 10%.
  • the frequency of atrial excitement during atrial fibrillation is 300-600 beats/min.
  • the heartbeat frequency is often fast and irregular. Sometimes it can reach 100-160 beats/min. It is not only faster than normal people's heartbeat, but also neat, the atrium is effectively lost. Shrinkage function.
  • the increase in the prevalence of atrial fibrillation is also closely related to diseases such as coronary heart disease, hypertension and heart failure.
  • the general treatment of atrial fibrillation is mainly based on drug therapy.
  • the drug can restore and maintain sinus rhythm, control ventricular rate and prevent thromboembolic complications.
  • a number of non-pharmacological treatments have been developed, such as cardioversion, catheter ablation, surgical maze, and anticoagulation.
  • Atrial fibrillation can also cause stroke and other thrombotic events. About 5% of patients with atrial fibrillation have strokes each year, and the mortality and disability rate caused by stroke is as high as 50%. How to prevent or reduce stroke caused by atrial fibrillation is important. In recent years, several clinical studies have shown that blocking the left atrial appendage can reduce the risk of stroke in patients with atrial fibrillation. At present, the mainstream left atrial appendage occlusion in the world is percutaneous puncture closure. The surgical procedure is complicated and requires a puncture room interval. The operation is difficult and the instruments used are complicated. X-ray is generally used as a guide during the operation, and radiation damage is caused to both the doctor and the patient.
  • Cimbona percutaneous left atrial appendage occluder comprising: a hemispherical end steel sleeve, a hemisphere, a hemispherical polyester membrane, a hexagonal disk surface polyester membrane, and a sixth Edge disk, cone-end polyester diaphragm, cone and cone end steel sleeve; hemisphere and cone are woven from superelastic memory alloy wire into a mesh bracket with a hexagonal disk between the hemisphere and the cone a polyester diaphragm inside the hexagonal disk surface; the hemispherical nickel-titanium wire is tightened in the center of the hemisphere and fixed on the hemispherical steel sleeve, and the hemispherical steel sleeve is provided with a precision internal thread, which can be screwed with the distal bolt of the push cable.
  • the nitinol wire of the cone is tightened in the center of the bottom surface of the cone and fixed with a cone end steel sleeve, and the cone end steel sleeve is recessed inside the cone; the hemisphere and the cone are six sides
  • the disk surface; inside the mesh bracket respectively have a hemispherical polyester film, a hexagonal disk surface polyester film and a cone-end polyester film.
  • This patent is applied to the left atrial appendage surgery, but this patent has only a hexagonal disk surface, which is likely to fall off when the left atrial appendage is blocked. At the same time, the hexagon may also cause damage to the inner wall of the left atrial appendage, and this patent is The structure is also relatively simple, not According to the patient's left atrial appendage and its inner wall, all are still not ideal.
  • the technical problem to be solved by the present invention is to provide a left atrial appendage occluder which has a simple structure, is convenient to use, reduces the difficulty of surgery, and can be attached to the inner wall according to the specific condition of the left atrial appendage to overcome the above-mentioned drawbacks of the prior art.
  • a left atrial appendage occluder comprising a nickel-titanium alloy mesh support, the nickel-titanium alloy mesh support is in a cylindrical shape, and two ends of the nickel-titanium alloy mesh support are provided There are a left disk surface and a right disk surface, and the left disk surface and the right disk surface are connected by a movable portion, and the left disk surface and the right disk surface are respectively provided with a flow blocking film in a lateral direction.
  • one or two layers of the flow blocking film are also disposed in the movable portion in the radial direction.
  • the flow blocking film is a polytetrafluoroethylene material or a polyethylene terephthalate material.
  • the diameter of the left disk surface is smaller than the diameter of the right disk surface.
  • the movable portion has a tapered shape, and one end of the movable portion connected to the left disk surface is thinner than the end connected to the right disk surface.
  • Another problem to be solved by the present invention is to provide a method for manufacturing the above left atrial appendage occluder, the technical method thereof
  • the case is as follows: 1. Using an automatic knitting machine or hand-weaving to weave a nickel-titanium alloy wire into a slender tubular blank;
  • the woven blank net is placed in a heat treatment resistance furnace and heated to 250°-350°, and taken out after heat preservation;
  • the heat-treated blank web is cut into 20-100 mm, and the two ends of the cut-off portion are clamped or sealed by a stainless steel sleeve or sealed by welding;
  • the blank net is shaped by a shaping die, and the shaping die comprises a concave die, an inner core and upper and lower glands, and the inner core of the shaping die is placed into the blank net from the mesh of the blank mesh, and the inner core is provided.
  • the blank net is placed into the cavity of the die of the shaping die, and then the stainless steel sleeve or the welding head at both ends of the blank mesh is fitted on the upper and lower gland of the forming die, and finally the upper and lower glands are compacted and fixed. On the cavity;
  • the molding die with the blank mesh is placed in a heat treatment resistance furnace and heated to 500° to 550°, and then taken out after heat preservation to form a nickel-titanium alloy mesh support;
  • a barrier film of at least two layers of polytetrafluoroethylene or polyethylene terephthalate material is placed inside the nickel-titanium alloy stent, and finally a left atrial appendage occluder is formed.
  • the heating time in the first step is 10 to 40 minutes, and the holding time is 30 to 60 minutes.
  • the Nitinol wire is woven on the stainless steel round bar, and after being woven, it is placed in a heat treatment resistance furnace for heat treatment.
  • the holding time in the step 5 is 10-20 min.
  • the polytetrafluoroethylene or polyethylene terephthalate material choke film in the step 6 is fixed inside the nitinol stent by suture.
  • the left atrial appendage occluder of the present invention and the manufacturing method thereof have the following beneficial effects:
  • the invention is applied to a surgical interventional operation, and does not need to establish a vein-left atrial appendage track during operation, but uses ultrasound guidance without using X-ray irradiation, so that both doctors and patients are not affected by X-ray rays;
  • the left intercostal small incision allows direct visualization of the left atrial appendage and direct use of the present invention, which makes the surgical procedure simpler and faster.
  • the invention also adopts double disk surface sealing, and the left disk surface of the occluder is in the left atrial appendage, and the occluder can be effectively fixed to prevent the occluder from falling off, and the concave and convex structures generated by different diameters of the two disk surfaces and the movable portion can be effectively obtained.
  • the occluder is fixed on the left atrial appendage; and after the occluder enters the left atrial appendage, the length of the occluder can be automatically adjusted according to the shape of the left atrial appendage, which is convenient and reliable to use.
  • Figure 1 is a schematic view showing the initial state of fabrication of the present invention.
  • FIG. 2 is a schematic structural view of a molding die.
  • Figure 3 is a schematic view of the present invention installed in a molding die.
  • Figure 4 is a schematic view showing the first structure of the present invention.
  • Figure 5 is a schematic view of the second structure of the present invention.
  • Figure 6 is a schematic view showing the third structure of the present invention.
  • Figure 7 is a schematic illustration of an embodiment of the invention at the time of surgery.
  • a left atrial appendage occluder of the present invention as shown in any of Figures 4-7, comprising a nickel-titanium mesh stent 1 having a cylindrical shape, the nitinol mesh stent Both ends of the 1 are provided with a left disk surface 11 and a right disk surface 12, and the left disk surface 11 and the right disk surface 12 are connected by a movable portion 13, which can be elongated, compressed or twisted as needed; the left disk surface
  • the baffle film 2 is provided in each of the right and left disk faces 12 in the lateral direction.
  • the flow-blocking film 2 described in this embodiment is a polytetrafluoroethylene material or a polyethylene terephthalate material.
  • the movable portion 13 is also provided with 1 to 2 layers of the flow-blocking film 2 in the lateral direction.
  • the invention is applied in the sealing operation of the left atrial appendage, and the shape of the left atrial appendage is generally conical, in order to better fit the inner wall of the left atrial appendage, the choke membrane 2 fully functions as a choke, the left disc surface
  • the diameter of 11 is smaller than the diameter of the right disk surface 12.
  • the movable portion 13 has a cone shape, the diameter of the left disk surface 11 is larger than the maximum diameter of the left end of the movable portion 13, and the diameter of the right disk surface 12 is larger than the movable portion 13 The maximum diameter of the right end, and one end of the movable portion 13 connected to the left disk surface 11 is thinner than the end connected to the right disk surface 12. Since the present invention is occluded in the left atrial appendage, the diameter of the left and right disk faces 11 and 12 is greater than the diameter of the left atrial appendage to avoid detachment.
  • the method for manufacturing the left atrial appendage occluder of the present invention comprises the following steps:
  • the nickel-titanium alloy wire is first woven into a slender cylindrical blank web using an automatic knitting machine or hand-woven.
  • the Nitinol wire can be woven on the stainless steel slender round bar, and the Nitinol wire is fixed on both ends of the round bar by using the hoop, and the woven blank net and the stainless steel round bar are placed together in the next heat treatment. Into the heat treatment resistance furnace, this also ensures that the blank after the heat treatment is not deformed.
  • the blank web described in this embodiment refers to a prototype of a nickel-titanium alloy mesh stent which is not completely formed, and has a uniform elongated tubular shape.
  • the nickel-titanium alloy wire cannot be damaged, and the yarn breakage and crack generation are avoided. And determining the time and temperature during the heat treatment according to the size of the blank net.
  • the woven blank net is placed in a heat treatment resistance furnace for heating, heating to a temperature of 250° to 350°, and a heating time of 10 to 40 minutes. It is most preferable to heat the blank web to 250°, and after the predetermined treatment time is reached, the heating is stopped and kept for 30 to 60 minutes, and then the blank web is taken out from the heat treatment resistance furnace and naturally cooled to room temperature in the air.
  • the preliminary setting is completed, and the heat-treated blank net is intercepted by 20 to 100 mm as needed, and the cut ends of the blank net are clamped and sealed by the stainless steel sleeve 3 or sealed by welding.
  • a molding process is required, and the molding uses a molding die including a concave die 61, an inner core 62, an upper pressing cover 63 and a lower pressing cover 64.
  • the concave mold 61 has a cavity and a cavity.
  • the shape is adapted to the shape of the shaped left atrial appendage occluder (shown in Figures 4-6).
  • the operation steps are: the mesh of the blank web after sealing can be expanded to a certain size, and the inside of the forming mold is The core 62 is placed in the blank web through a mesh, the blank web with the inner core 62 is placed into the cavity of the female mold 61, and then the stainless steel sleeve 3 at both ends of the blank net is fitted to the upper and lower sides of the forming mold. Of the corresponding fixing holes of the glands 63, 64, the upper and lower glands 63, 64 are finally fixedly fixed to the die 61.
  • the external force applied by the upper and lower glands 63, 64 can cause the blank web to be filled in the cavity of the female mold 61, and at the same time because of the action of the inner core 62.
  • the blank web can finally form a left disk surface 11 and a right disk surface 12 in the cavity, and a movable portion 13 that can be twisted and stretched.
  • the forming mold together with the blank web therein is placed in a heat treatment resistance furnace for final shaping.
  • the final shaped blank web should meet two requirements: one must ensure the overall strength to ensure the effect of the support, and can not fall off; the second is to ensure that the movable portion 13 in the middle can be twisted and stretched to fit the inner cavity of the left atrial appendage;
  • the inventors have determined the temperature of the final shaped heat treatment to be 500° to 550° after a large number of tests, and after heating to the above temperature, the temperature is kept in the heat treatment resistance furnace for 10 to 20 minutes, and after being taken out, it is rapidly cooled to room temperature in water to complete the final.
  • Stereotype after cooling to room temperature, the inner core is taken out through the mesh between the nets to form a nitinol mesh support 1.
  • EPTFE polytetrafluoroethylene
  • PET polyethylene terephthalate
  • a layer of the baffle film 2 is disposed in each of the left disk surface 11 and the right disk surface 12, and in order to further ensure the flow blocking effect in actual use, the movable portion 13 may be provided with at least one layer of the flow blocking film. 2.
  • the movable portion 13 may have various structural forms, such as a sleeve shape formed in FIG. 4 and FIG. 5 or a stepped shape formed in FIG. 6, and a form such as a corrugated shape, as long as it satisfies The shape can be twisted or stretched.
  • the specific structure of the left disk surface 11 and the right disk surface 12 is also determined according to actual conditions.
  • the left disk surface 11 shown in FIG. 4 is relatively thick, which can increase the contact area with the left atrial appendage and is more stable.
  • the occluder of the present invention is applied to a surgical interventional operation, which does not require the establishment of a venous-left atrial appendage, but a small incision between the left ribs of the patient, through which a left incision can be directly viewed, and then ultrasound guided
  • the patient and medical staff are not affected by X-rays, and the use of the present invention makes the surgical procedure simpler and faster.
  • the right disk surface 12 of the present invention is outside the left atrial appendage, and the occluder of the present invention can be effectively fixed to prevent it from falling off.
  • the diameter of the movable portion 13 between the left disk surface 11 and the right disk surface 12 is smaller than the diameter of the left disk surface 11 and the right disk surface 12.
  • the structure of the middle thin end is formed thick, which can effectively fix the occluder on the left atrial appendage.
  • the length and shape of the movable portion 13 can be automatically adjusted according to the shape of the left atrial appendage, and the movable portion 13 can automatically align the occluder with the center of the left atrial appendage.
  • the occluder of the present invention is an embodiment of the present invention at the time of surgery, after cutting a small incision between the left side of the patient's left side, and then cutting the left atrial appendage 4 out of the opening, using ultrasonic guidance, the occluder of the present invention
  • the inner cavity of the left atrial appendage 4 extends into the left atrium 5
  • the disc surface of the right disc surface 12 fits on the inner wall of the left atrium 5
  • the movable portion 13 is fitted to the inner wall of the left atrial appendage 4
  • the left disc surface 11 is stuck to the left atrial appendage. 4 cut out the opening.
  • the baffle film 2 in the right disk surface 12 can effectively block blood from entering the left atrial appendage 4, and the baffle film 2 in the middle movable portion 13 can further block the blood; since the left disk surface 11 is stuck at the opening, the entire seal The two ends of the plug are sandwiched between the left atrial appendages so that the occluder does not slide into the left atrium 5 and does not fall off the left atrial appendage 4; at the same time, the function of the choke membrane 2 in the left disc surface 11 It is an opening that blocks blood from flowing out of the left atrial appendage 4.
  • the left atrial appendage occluder of the present invention and the manufacturing method thereof can solve the safety problem of the left atrial appendage sealing operation, and save the operation time, and the effect is good. Therefore, the present invention effectively overcomes some practical problems in the prior art and has high utilization value and use significance.

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Abstract

一种左心耳封堵器及其制作方法。左心耳封堵器包括镍钛合金网支架(1)。镍钛合金网支架(1)呈筒状，其两端设有左盘面(11)和右盘面(12)，左盘面(11)和右盘面(12)通过活动部(13)相连接，左盘面(11)和右盘面(12)中在横向分别设有阻流膜(2)。左心耳封堵器的制作方法包括编织成细长网状，然后再进行初步热处理、成型、最终热处理等步骤完成一个左心耳封堵器的制作。该左心耳封堵器结构简单、使用方便，可以简化手术过程，缩短手术时间，同时在使用该左心耳封堵器进行左心耳封堵手术时不需要使用X光射线，大大减小了对医患双方的危害。通过该左心耳封堵器的制作方法制作的左心耳封堵器性能良好、使用可靠。

Description

左心耳封堵器及其制作方法 技术领域
本发明涉及一种心脏手术医疗器械，尤其涉及一种左心耳封堵器及其制作方法。
背景技术
心房颤动(房颤)是一种临床上最为常见的心律失常之一，人群发病率约0.89％，其中发病率随年龄增高，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，有时候可达100～160次/分，不仅比正常人心跳快得多，而且不整齐，心房失去有效的收缩功能。房颤患病率的增长还会与冠心病、高血压病和心力衰竭等疾病密切相关。一般的房颤治疗方法主要以药物治疗为主，药物能回复和维持窦性心律，控制心室率以及预防血栓栓塞并发症。随着医疗水平提高，还研究产生了多种非药物治疗，例如电复律、导管消融治疗、外科迷宫手术和抗凝治疗。
房颤除了可以诱发和加重心力衰竭外，还可以引起脑卒中及其他血栓事件，每年约有5％的房颤患者发生脑卒中，而脑卒中引起的致死率及致残率高达50％，因此如何预防或减少因房颤血栓而引发的脑卒中具有重要意义。近年来多项临床研究表明对左心耳进行封堵可降低房颤患者的脑卒中风险。目前，世界上主流的左心耳封堵术，是经皮穿刺封堵术，手术过程复杂，需要进穿刺房间隔，手术难度较大，所用器械较为复杂。手术过程中一般使用X光作为引导，对医患双方都有辐射伤害。
专利号为CN 203263451U的中国专利公开了一种经皮左心耳封堵器，该封堵器包括：半球端钢套、半球、半球端聚酯膜片、六边形盘面聚酯膜片、六边形盘面、锥体端聚酯膜片、锥体和锥体端钢套；半球和锥体由超弹性记忆合金丝编织呈网状支架，在半球和锥体之间有一个六边形盘面，在六边形盘面内部有聚酯膜片；半球的镍钛丝收紧于半球中央并固定在半球钢套上，半球钢套设有精密内螺纹，能与推送钢缆的远端螺栓旋进旋出；锥体的镍钛合金丝收紧于锥体底面中央并固定有锥体端钢套，锥体端钢套收紧处凹陷于锥体内部；半球与锥体之间是六边形盘面；在网状支架内部分别有半球端聚酯膜片、六边形盘面聚酯膜片以及锥体端聚酯膜片。此专利应用于左心耳封堵手术中，但是此专利只有一个六边形盘面，封堵左心耳时很可能出现脱落的现象，同时六边形对于左心耳内壁也可能造成伤害，并且此专利在结构上也比较单一，不能 根据病人左心耳具体情况与其内壁贴合，所有依然不是很理想。
发明内容
本发明要解决的技术问题在于提供一种结构简单、使用方便、减小手术难度，并且可以根据左心耳的具体情况与其内壁贴合的左心耳封堵器以克服现有技术的上述缺陷。
为了解决上述技术问题，本发明采用如下技术方案：一种左心耳封堵器，包括镍钛合金网支架，所述镍钛合金网支架呈筒状，所述镍钛合金网支架的两端设有左盘面和右盘面，所述左盘面和右盘面通过活动部相连接，所述左盘面和右盘面中在横向分别设有阻流膜。
优选地，所述活动部中在径向也设有1～2层阻流膜。
优选地，所述阻流膜为聚四氟乙烯材料或聚对苯二甲酸乙二醇酯材料。
优选地，所述左盘面的直径小于右盘面的直径。
进一步地，所述活动部为锥筒状，并且所述活动部与左盘面连接的一端比与右盘面连接的一端细。
本发明要解决的另一个问题是提出一种上述左心耳封堵器的制作方法，其技术方
案如下：一、使用自动编织机或者手工编织将镍钛合金丝编织成细长筒状的坯料网；
二、将编织好的坯料网置入热处理电阻炉中加热至250°～350°，保温后取出；
三、将热处理后的坯料网截取20～100mm，将截取部分的两端通过不锈钢套夹紧封口或通过焊接封口；
四、封口后的坯料网通过定型模具进行定型处理，定型模具包括凹模、内芯和上、下压盖，将定型模具的内芯从坯料网网孔放入坯料网，将带有内芯的坯料网放入到定型模具凹模的型腔中，然后将坯料网两端的不锈钢套或焊接头配合安装在成型模具的上、下压盖上，最后将上、下压盖压实固定在型腔上；
五、将带有坯料网的成型模具置入热处理电阻炉中加热至500°～550°，保温后取出，形成镍钛合金网支架；
六、将至少两层聚四氟乙烯或聚对苯二甲酸乙二醇酯材料的阻流膜置入镍钛合金支架内部，最后形成左心耳封堵器。
优选地，所述步骤一中的加热时间为10～40min，保温时间为30～60min。
优选地，所述步骤一中将镍钛合金丝编织在不锈钢圆棒上，并且在编织好后一起置入热处理电阻炉中进行热处理。
优选地，所述步骤五中的保温时间为10～20min。
优选地，所述步骤六中的聚四氟乙烯或聚对苯二甲酸乙二醇酯材料阻流膜通过缝线固定在镍钛合金支架内部。
如上所述，本发明左心耳封堵器及其制作方法，具有以下有益效果：
本发明应用在外科介入手术，在手术时不需要建立静脉-左心耳轨道，而是使用超声引导，不需要使用X光射线照射，因此医患双方不会受到X光射线影响；同时手术时通过左侧肋间小切口，可以直视左心耳进而直接使用本发明，这使得手术过程更加简单快速。本发明还采用双盘面封堵涉及，封堵器的左盘面在左心耳中，可以有效地固定封堵器，避免封堵器脱落，两个盘面和活动部不同直径产生的凹凸结构可以有效得将封堵器固定在左心耳上；并且封堵器进入左心耳后，可以根据左心耳的形态自动调节封堵器的长短，使用方便、可靠。
附图说明
图1为本发明的制作初始状态示意图。
图2为成型模具的结构示意图。
图3为本发明安装在成型模具中的示意图。
图4为本发明的第一种结构示意图。
图5为本发明的第二种结构示意图。
图6为本发明的第三种结构示意图。
图7为本发明的在手术时的实施方式示意图。
图中：1   镍钛合金网支架  11  左盘面
      12  右盘面          13  活动部
      2   阻流膜          3   不锈钢套
      4   左心耳          5   左心房
      61  型腔            62  内芯
      63  上压盖          64  下压盖
具体实施方式
说明书附图所绘示的结构、比例、大小等，均仅用以配合说明书所揭示的内容，以供熟悉此技术的人士了解与阅读，并非用以限定本发明可实施的限定条件，故不具技术上的实质意义，任何结构的修饰、比例关系的改变或大小的调整，在不影响本发明所能产生的功效及所能达成的目的下，均应仍落在本发明所揭示的技术内容所能涵盖的范围内。同时，本说明书中所引用的如“上”、“下”、“前”、“后”、“中间”等用语，亦仅为便于叙述的明了，而非用以限定本发明可实施的范围，其相对关系的改变或调整，在无实质变更技术内容下，当亦视为本发明可实施的范畴。
如图4—图7中任意附图所示的本发明一种左心耳封堵器，包括镍钛合金网支架1，所述镍钛合金网支架1呈筒状，所述镍钛合金网支架1的两端设有左盘面11和右盘面12，所述左盘面11和右盘面12通过活动部13相连接，所述活动部13可以根据需要伸长、压缩或者扭动；所述左盘面11和右盘面12中在横向分别设有阻流膜2。本实施例中所述的阻流膜2为聚四氟乙烯材料或聚对苯二甲酸乙二醇酯材料。
在本实施例中，为了在实际使用时进一步阻挡血液的流通，所述活动部13中在横向也设有1～2层阻流膜2。
本发明应用在左心耳的封堵手术中，左心耳的形状通常是锥形，为了可以更好地与左心耳的内壁贴合，让阻流膜2充分起到阻流作用，所述左盘面11的直径小于右盘面12的直径。在手术安装时，左盘面11在左心耳较细一端，右盘面12在左心耳较粗一端。进一步地，为了便于配合左心耳的内腔中，所述活动部13为锥筒状，所述左盘面11的直径大于活动部13左端的最大直径，所述右盘面12的直径大于活动部13右端的最大直径，并且所述活动部13与左盘面11连接的一端比与右盘面12连接的一端细。因为本发明封堵在左心耳中，为了避免脱落，所述的左盘面11和右盘面12的直径要大于左心耳内腔的直径。
本发明左心耳封堵器的制作方法包括如下步骤：
首先使用自动编织机或者手工编织将镍钛合金丝编织成细长筒状的坯料网。为了便于编织，可以将镍钛合金丝编织在不锈钢细长圆棒上，并使用抱箍将镍钛合金丝在圆棒两端固定，在下一步热处理时将编织好的坯料网和不锈钢圆棒一起置入热处理电阻炉中，这样也保证了热处理后的坯料网不会发生变形。本实施例中所述的坯料网是指未完全成型的镍钛合金网支架雏形，呈均匀的细长筒状。
上述热处理过程中要保证不能对镍钛合金丝造成伤害，避免断丝和裂纹产生，并 且根据坯料网的大小确定热处理过程中的时间和温度，一般情况下将编织好的坯料网置入热处理电阻炉中进行加热，加热到温度为250°～350°，加热时间为10～40min。其中将坯料网加热至250°最为理想，并且在达到预定处理时间后，停止加热并保温30～60min，然后从热处理电阻炉中取出坯料网在空气中自然冷却至室温。
坯料网冷却至室温后完成初步定型，根据需要将热处理后的坯料网截取20～100mm，将截下的坯料网两端通过不锈钢套3夹紧封口或通过焊接封口。
封口结束后需要进行成型处理，成型使用成型模具，所述成型模具包括一个凹模61、一个内芯62、一个上压盖63和一个下压盖64，凹模61中具有型腔，型腔的形状与成型后的左心耳封堵器(如图4—6所示)的形状相适应。在本实施例中，以坯料网两端为不锈钢套3为例，结合图1—图4，其操作步骤是：封口后的坯料网上的网孔可以撑开到一定大小，将成型模具的内芯62通过一个网孔放入坯料网中，将带有内芯62的坯料网放入到凹模61的型腔中，然后将坯料网两端的不锈钢套3配合安装在成型模具的上、下压盖63、64的对应固定孔中，最后将上、下压盖63、64压实固定在凹模61上。在压实固定的过程中，因为坯料网本身具有张力，再加上上、下压盖63、64施加的外力可以使得坯料网充填在凹模61的型腔中，同时因为内芯62的作用，坯料网最终可以在型腔中形成左盘面11和右盘面12，以及可以扭动、拉伸的活动部13。
将成型模具连同其中的坯料网置入热处理电阻炉中进行最终定型。最终定型的坯料网要满足两个要求：一要确保整体的强度进而保证支撑的效果，不能脱落；二要保证中间的活动部13可以进行扭动、拉伸以便于配合左心耳的内腔；为了达到上述要求，发明人经过大量试验将最终定型的热处理的温度确定为500°～550°，加热至上述温度后在热处理电阻炉中保温10～20min，取出后在水中快速冷却至室温完成最终定型；冷却至室温后，通过网之间的网孔将内芯取出，形成镍钛合金网支架1。
最后，将至少两层聚四氟乙烯(EPTFE)或聚对苯二甲酸乙二醇酯(PET)材料的阻流膜2置入定型后的镍钛合金网支架1内部。所述阻流膜2为高分子结构，将阻流膜2从镍钛合金网支架1的网孔中塞入内部，阻流膜2会充分张开，张开后的阻流膜2再通过缝线缝合固定在镍钛合金网支架1中。一般情况在要在左盘面11和右盘面12中各设置一层阻流膜2，在实际使用时为了进一步保证阻流效果，所述的活动部13中也可以设有至少一层阻流膜2，阻流膜2装好后一个完整的左心耳封堵器制作完成。
如图4—图6所示，活动部13的结构形式可以有多种，例如图4、图5中形成的套管状或图6中形成的阶梯状，还有例如波纹状等形式，只要满足可以扭动、拉伸条件的形状都可以。与此同时，所述左盘面11和右盘面12的具体结构也根据实际情况确定，例如图4中所示的左盘面11就比较厚，这样可以增大与左心耳的接触面积，更加稳定。
本发明的封堵器应用在外科介入手术，外科介入手术不需要建立静脉-左心耳轨道，而是在病人的左侧肋间开小切口，通过小切口可以直视左心耳，然后使用超声引导，病人和医护人员不会受到X射线影响，使用本发明使得手术过程更加简单快速。本发明的右盘面12在左心耳外侧，可以有效地固定本发明的封堵器，避免其脱落，左盘面11和右盘面12之间的活动部13直径小于左盘面11和右盘面12的直径，即形成中间细两端粗的结构，这可以有效得将封堵器固定在左心耳上。封堵器进入左心耳后，可以根据左心耳的形态自动调节活动部13长短和形状，活动部13可以将封堵器自动对准左心耳口中心。
结合图4和图7为本发明在手术时的实施方式，在将病人的左侧肋间切出小切口后，再将左心耳4切出开口，使用超声引导，将本发明的封堵器沿着左心耳4的内腔伸入到左心房5，右盘面12的盘面贴合在左心房5的内壁上，活动部13与左心耳4的内壁贴合，左盘面11则卡在左心耳4切出的开口处。右盘面12中的阻流膜2可以有效的阻挡血液进入左心耳4中，中间的活动部13中的阻流膜2可以进一步阻挡血液；因为左盘面11是卡在开口处的，所以整个封堵器的两端是将左心耳夹在中间，使得封堵器既不会滑入到左心房5中，又不会从左心耳4上脱落；同时左盘面11中的阻流膜2的作用是阻挡血液流出左心耳4的开口处。
综上所述，本发明左心耳封堵器及其制作方法，能够解决左心耳封堵手术时安全问题，同时节省手术时间，效果好。所以，本发明有效克服了现有技术中的一些实际问题从而有很高的利用价值和使用意义。
上述实施方式仅例示性说明本发明的原理及其功效，而非用于限制本发明。本发明还有许多方面可以在不违背总体思想的前提下进行改进，对于熟悉此技术的人士皆可在不违背本发明的精神及范畴下，可对上述实施例进行修饰或改变。因此，举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变，仍应由本发明的权利要求所涵盖。

Claims (10)

  1. 一种左心耳封堵器，其特征在于：包括镍钛合金网支架(1)，所述镍钛合金网支架(1)呈筒状，所述镍钛合金网支架(1)的两端设有左盘面(11)和右盘面(12)，所述左盘面(11)和右盘面(12)通过活动部(13)相连接，所述左盘面(11)和右盘面(12)中在横向分别设有阻流膜(2)。
  2. 根据权利要求1所述的左心耳封堵器，其特征在于：所述活动部(13)中在径向也设有1～2层阻流膜(2)。
  3. 根据权利要求1所述的左心耳封堵器，其特征在于：所述阻流膜(2)为聚四氟乙烯材料或聚对苯二甲酸乙二醇酯材料。
  4. 根据权利要求1所述的左心耳封堵器，其特征在于：所述左盘面(11)的直径小于右盘面(12)的直径。
  5. 根据权利要求4所述的左心耳封堵器，其特征在于：所述活动部(13)为锥筒状，并且所述活动部(13)与左盘面(11)连接的一端比与右盘面(12)连接的一端细。
  6. 一种权利要求1所述的左心耳封堵器的制作方法，其特征在于，包括如下步骤：
    一、使用自动编织机或者手工编织将镍钛合金丝编织成细长筒状的坯料网；
    二、将编织好的坯料网置入热处理电阻炉中加热至250°～350°，保温后取出；
    三、将热处理后的坯料网截取20～100mm，将截取部分的两端通过不锈钢套夹紧封口或通过焊接封口；
    四、封口后的坯料网通过定型模具进行定型处理，定型模具包括凹模(61)、内芯(62)和上、下压盖(63、64)，将定型模具的内芯(62)从坯料网网孔放入坯料网，将带有内芯(62)的坯料网放入到定型模具凹模(61)的型腔中，然后将坯料网两端的不锈钢套或焊接头配合安装在成型模具的上、下压盖(63、64)上，最后将上、下压盖(63、64)压实固定在型腔上；
    五、将带有坯料网的成型模具置入热处理电阻炉中加热至500°～550°，保温后 取出，形成镍钛合金网支架(1)；
    六、将至少两层聚四氟乙烯或聚对苯二甲酸乙二醇酯材料的阻流膜(2)置入镍钛合金支架(1)内部，最后形成左心耳封堵器。
  7. 根据权利要求6所述的左心耳封堵器的制作方法，其特征在于：所述步骤一中的加热时间为10～40min，保温时间为30～60min。
  8. 根据权利要求6所述的左心耳封堵器的制作方法，其特征在于：所述步骤一中将镍钛合金丝编织在不锈钢圆棒上，并且在编织好后一起置入热处理电阻炉中进行热处理。
  9. 根据权利要求6所述的左心耳封堵器的制作方法，其特征在于：所述步骤五中的保温时间为10～20min。
  10. 根据权利要求6所述的左心耳封堵器的制作方法，其特征在于：所述步骤六中的聚四氟乙烯或聚对苯二甲酸乙二醇酯材料阻流膜(2)通过缝线固定在镍钛合金支架(1)内部。
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WO2018069523A1 (de) * 2016-10-13 2018-04-19 Cormos Medical Gmbh Laa-occluder zum verschluss des linken herzohrs
CN110960279A (zh) * 2018-09-29 2020-04-07 上海微创医疗器械（集团）有限公司 左心耳封堵器及左心耳封堵系统
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