WO2021185127A1 - 一种降落伞设计生物可降解封堵器 - Google Patents

一种降落伞设计生物可降解封堵器 Download PDF

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Publication number
WO2021185127A1
WO2021185127A1 PCT/CN2021/079880 CN2021079880W WO2021185127A1 WO 2021185127 A1 WO2021185127 A1 WO 2021185127A1 CN 2021079880 W CN2021079880 W CN 2021079880W WO 2021185127 A1 WO2021185127 A1 WO 2021185127A1
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Prior art keywords
occluder
forming ring
distal
proximal
disc surface
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PCT/CN2021/079880
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English (en)
French (fr)
Inventor
陈娟
王云兵
王帆
胡金鹏
许贤春
Original Assignee
上海形状记忆合金材料有限公司
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Priority claimed from CN202010179058.2A external-priority patent/CN111297412A/zh
Priority claimed from CN202020319917.9U external-priority patent/CN212326463U/zh
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 BR112022018180A priority Critical patent/BR112022018180A2/pt
Priority to EP21771663.8A priority patent/EP4122401A4/en
Priority to US18/016,466 priority patent/US20230277166A1/en
Publication of WO2021185127A1 publication Critical patent/WO2021185127A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • 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
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592—Elastic or resilient implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00597—Implements comprising a membrane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00619—Locking means for locking the implement in expanded state
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00623—Introducing or retrieving devices therefor
    • 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
    • A61B2017/00871—Material properties shape memory effect polymeric
    • 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
    • A61B2017/00946—Material properties malleable

Definitions

  • the invention relates to a biodegradable occluder.
  • the use of conventional metal occluders for treatment will be accompanied by a certain rate of complications. Since the nickel-titanium alloy material is not degradable, the occluder will permanently exist in the heart after being implanted in the human body. At the same time, it also limits the possibility of other treatments in the later period, such as occlusion of the left atrial appendage. For occlusion of ventricular septal defect, there is a certain probability that conduction block will occur; after the occluder is implanted in the human body, because the material is relatively hard, there will be a certain degree of friction and wear on the defect tissue and surrounding tissues.
  • the purpose of the present invention is to provide an occlusion device that can produce a occlusion effect in a short period of time, and can be degraded or absorbed by tissues after long-term endothelialization.
  • the technical solution of the present invention is to provide a parachute design biodegradable occluder.
  • the end close to the human body is defined as the proximal end, and the end far away from the human body is defined as the distal end.
  • the occluder stent, baffle membrane and forming ring are all made of high molecular polymer materials with degradable properties in biological tissues. Among them:
  • the distal end of the occluder holder is the distal disc surface, and the proximal end is the proximal disc surface.
  • the part of the occluder holder located between the distal disc surface and the proximal disc surface is the waist of the occluder.
  • the proximal end of the occluder holder is provided with a joint.
  • the forming ring enters the occluder holder through the through hole of the connector;
  • the state of the forming ring is switched between the contracted state and the expanded state; in the unconstrained or unstressed state, the forming ring is in the expanded state, and the expanded forming ring is inside the occluder stent, and the occluder is not formed at this time ,
  • the occluder can be delivered in a slender delivery sheath; after applying external force, the forming ring changes from the expanded state to the contracted state, and the forming ring in the contracted state can pass through the through hole of the joint on the occluder bracket; when the external force After the removal, the forming ring returns to the expanded state, and the occluder stent relies on its own certain resilience performance and the auxiliary forming of the forming ring to restore the deformed occluder stent to the design state.
  • the proximal end of the molding ring is a proximal structure that facilitates the application of external force to the molding ring.
  • the distal end of the molding ring has M connecting wires, M ⁇ 3.
  • the M connection points of the connecting line and the distal disc surface are located on or within the projection circle of the waist diameter of the occluder; when a force is applied to the proximal structure of the forming ring, the force passes through the connecting line at the distal end of the forming ring Distribute evenly to each connection point to realize the buckling of the waist of the occluder, and drive the distal disc surface and the proximal disc surface to adhere to each other.
  • the flow blocking film is arranged as a single layer or as N layers, with N ⁇ 2.
  • the forming ring drives the center of the distal disk surface to be concave, and the inner side of the distal disk surface squeezes the waist of the occluder, thereby Increase the lumbar support of the occluder.
  • the forming ring is bound to the contracted state through the through hole of the joint on the occluder bracket, so as to realize the overall recovery of the biodegradable occluder.
  • the occluder provided by the present invention is softer, and the occluder produces less friction and wear on the defect tissue and its surroundings after being implanted in the human body.
  • the special molding ring design of the occluder can complete the expected molding of the left and right disks of the occluder, compensate for the poor resilience of the occluder material, and finally achieve a smooth fit with the defect tissue to achieve the occlusion effect.
  • the occluder provided by the present invention has a recovery function, which can solve some abnormal situations that may occur clinically as much as possible, and realize the optimal treatment for the patient.
  • the surgical operation of the occluder provided by the present invention is simple. Compared with the previous surgical operation process of the metal occluder, a better occlusion treatment is realized without increasing the complexity of the surgical operation.
  • Figure 1 is a schematic structural diagram of a biodegradable parachute design provided by the present invention
  • Figures 2 to 4 are schematic diagrams of biodegradable occluders designed for parachutes with different structures
  • Fig. 5 is a schematic diagram of a parachute design biodegradable occluder provided by the present invention after being formed at a defect site;
  • 6A and 6B are schematic diagrams of the forming ring of the first type of binding wire
  • FIGS. 7A and 7B are schematic diagrams of the forming ring of the second type of binding wire
  • 8A and 8B are schematic diagrams of a third type of wire binding forming ring
  • Figure 9 is a schematic diagram of a parachute design biodegradable occluder in a delivery sheath provided by the present invention.
  • the parachute design biodegradable occluder provided by the present invention is made of high-molecular polymer materials. This material has degradable properties in biological tissues, and finally decomposes into human body harmlessly, can be absorbed by the human body or can be absorbed by the human body. Substances metabolized by the human body.
  • the present invention includes an occluder holder 1, a baffle film 2 and a forming ring 4.
  • the occluder holder 1 can be woven from wire, or carved from a pipe, or made by 3D printing.
  • the direction close to the human body is defined as the proximal end, and the direction of the principle human body is defined as the distal end.
  • the distal end of the occluder holder 1 is a distal disc surface, and the proximal end is a proximal disc surface.
  • the part of the occluder holder located between the distal disc surface and the proximal disc surface is the waist of the occluder.
  • the proximal end of the occluder holder 1 has a joint with a through hole.
  • a developing mark 3 is provided at an appropriate position on the occluder support 1 or the baffle film 2, through which the unblocking device provided by the present invention can be accurately grasped.
  • the specific position of the developing mark 3 is set by those skilled in the art as required, and is not limited here.
  • the baffle film 2 is located in the occluder holder 1.
  • the person skilled in the art can install a single-layer baffle film 2 or a multi-layer baffle film 2 as needed.
  • the baffle membranes 2 are respectively distributed at the proximal end and the distal end of the occluder stent 1, and there is a through hole in the middle of the baffle membrane 2 at the proximal end.
  • the forming ring 4 is in the form of a parachute, that is, its overall shape is a round or elliptical shape in an unconstrained or unstressed state. At this time, the forming ring 4 is in an expanded state. At the same time, the proximal end of the forming ring 4 is a ring structure. Similar to a parachute, the forming ring 4 can be stowed to a contracted state or expanded to an expanded state. After the external force is applied to the forming ring 4 through the annular structure of the forming ring 4, the forming ring 4 changes from an expanded state to a contracted state.
  • the forming ring 4 is pulled by the forming line 5 to realize the application of external force to the forming ring 4.
  • the forming ring 4 in the contracted state can smoothly pass through the through hole of the proximal joint of the occluder holder 1 and the through hole in the middle of the blocking membrane 2 at the proximal end. Due to the binding effect of the through hole on the forming ring 4, the forming ring 4 always maintains a contracted state when passing through the through hole. After part or all of the molding ring 4 passes through the through hole to release the restriction, it will return to its original shape.
  • the distal end of the molding ring 4 is a connecting wire, and the connecting wire is connected to the distal disk surface of the occluder holder 1.
  • connection points between the molding ring 4 and the distal disk surface there are multiple (more than 3) connection points between the molding ring 4 and the distal disk surface, and each connection point is located on or in the projection circle of the waist diameter of the occluder.
  • the forming ring 4 contains 4 connecting lines, the connecting point of the forming ring 4 and the distal disk surface is located on the projection circle of the waist diameter of the occluder; the forming ring 4 contains 8 connecting lines, and the connecting point of the forming ring 4 and the distal disk surface is located at The center ring line of the distal disc surface; the forming ring 4 contains 8 connecting wires.
  • the connecting point of the forming ring 4 and the distal disc surface is located on the projection circle of the waist diameter of the occluder.
  • the forming effect of the connecting wire avoids problems such as entanglement and kinking between the connecting wires.
  • FIGS 6A and 6B, Figure 7A and Figure 7B, and Figure 8A and Figure 8B schematically show three different wire binding forms.
  • the binding wire form of the forming ring is the fixing pattern of the forming ring and the occluder bracket, as shown in Fig. 6A, Fig. 6B, Fig. 7A, Fig. 7B, Fig. 8A and Fig. 8B, there are different braiding connection modes.
  • the occluder stent 1 is made of polymer materials. Compared with metal materials, the memory resilience of polymer materials is relatively weaker. After the occluder stent 1 is delivered into the body through the delivery sheath, the memory resilience of the polymer material is relatively weak, so the occluder stent 1 cannot be restored to the designed shape.
  • the present invention implants a forming ring 4 in the occluder stent 1. The forming ring 4 partially in the expanded state or all in the expanded state forms a support for the occluder stent 1 and helps the occluder stent 1 Return to the design shape to compensate for the relatively weak memory resilience caused by polymer materials.
  • This connection method can restore the distal disk surface of the occluder stent 1 to the expected shape as much as possible, without bulging the distal disk surface or poorly attaching the wall at the defect position, resulting in thickening of the occluded position in the later stage.
  • the mutual adhesion of the distal disc surface and the proximal disc surface can reduce the occurrence of residual shunting of complications, and greatly improve the blocking effect of device treatment.
  • This connection method can also increase the lumbar support performance of the occluder.
  • the forming ring 4 drives the center of the distal disk surface to be concave, and the inner side of the distal disk surface squeezes the waist of the occluder, thereby increasing the lumbar support of the occluder and achieving stable fixation of the occluder .
  • connection method can increase the clamping performance between the distal disc surface and the proximal disc surface of the occluder.
  • Each connection point of the connection line of the forming ring 4 is located on or within the projection circle of the waist diameter of the occluder, which can increase the distal end
  • the disc surface is rigid, and at the same time, it drives the distal disc surface and the proximal disc surface to adhere to each other, increasing the clamping force of the two disc surfaces, and realizes the stable fixation of the occluder.
  • the occluder provided by the present invention also has a recyclable function.
  • the implanted occluder is not completely released and the immediate occlusion effect is observed by angiography, if the occlusion effect is not good or the occluder is not suitable, the occluder can be recovered and replaced with a more suitable one.
  • Blocker. The occluder is implanted in the human body.
  • the forming ring 4 passes through the through hole of the joint at the proximal end of the occluder holder 1 and is located outside the through hole or half of it is stuck in the through hole.
  • the forming ring 4 has a certain degree of elasticity. Return to the original circular or elliptical shape.
  • the occluder is completely formed, and the proximal and distal disks of the occluder are completely fastened, and smoothly fits the tissues of the defect site, and has a certain locking strength.
  • the conveying device is not separated from the joint at the proximal end of the occluder holder 1, and the conveying device is pulled back, but when the pulling force is greater than the locking strength of the forming ring 4, the forming The ring 4 will deform through the through hole of the joint. Due to the binding effect of the through hole on the forming ring 4, the forming ring 4 will remain in a contracted state and be pulled back into the occluder bracket again. Continue to apply a withdrawal force to the delivery device until the entire occluder is pulled back into the delivery sheath and finally withdrawn from the body.

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Abstract

一种降落伞设计生物可降解封堵器，将靠近人体的一端定义为近端，将远离人体的一端定义为远端，其包括内设有阻流膜（2）的封堵器支架（1）及状态可变的成型环（4），封堵器支架（1）、阻流膜（2）及成型环（4）均由在生物组织内具有可降解性能的高分子聚合物材料制成。该封堵器使用高分子生物可降解的材料制成，在人体组织中经过一段时间后可被人体组织分解或吸收，最终缺损部分由人体自身组织构成，实现无异物封堵，对于儿童而言，收益尤为明显。

Description

一种降落伞设计生物可降解封堵器 技术领域
本发明涉及一种生物可降解封堵器。
背景技术
常见的先天性心脏病有房间隔缺损、室间隔缺损、动脉导管未闭、卵圆孔未闭几种类型，以往外科开胸手术是治疗该类先天性心脏病的唯一有效地方法，随着介入医疗器械和介入手术技术的发展，使得以往需要开胸手术进行治疗的该类患者通过微创介入治疗即可治愈。常规的微创介入手术采用心脏封堵器进行封堵治疗，而目前市场上主流的封堵器使用镍钛合金材料制成，利用镍钛合金材料的超弹性特性，实现缺损位置的封堵治疗。
同时，使用常规的金属封堵器进行治疗的时候会伴随一定比率的并发症发生。由于镍钛合金材料不可降解，封堵器植入人体后永久存在于心脏，同时也限制后期其他治疗的可能性，如进行左心耳封堵等。对于室间隔缺损封堵，会有一定几率会发生传导阻滞；封堵器植入人体后，由于材料比较坚硬，对缺损组织及周围组织也有一定程度的摩擦和磨损。
发明内容
本发明的目的是提供一种短期内即可产生封堵效果，长期内皮化后可被组织降解或吸收的封堵器。
为了达到上述目的，本发明的技术方案是提供了一种降落伞设计生物可降解封堵器，将靠近人体的一端定义为近端，将远离人体的一端定义为远端，其特征在于，包括内设有阻流膜的封堵器支架及状态可变的成型环，封堵器支架、阻流膜及成型环均由在生物组织内具有可降解性能的高分子聚合物材料制成，其中：
封堵器支架远端为远端盘面、近端为近端盘面，封堵器支架位于远端盘面与近端盘面中间的部分为封堵器腰部，封堵器支架的近端设有接头，成型环通过接头的通孔进入封堵器支架内；
成型环的状态在收缩状态与扩张状态之间切换；在无束缚或无受力状态下， 成型环处于扩张状态，处于扩张状态的成型环在封堵器支架内部，此时封堵器未成型，封堵器可在细长的输送鞘管内输送，；在施加外力后，成型环由扩张状态向收缩状态变化，处于收缩状态的成型环可以通过封堵器支架上接头的通孔；当外力撤除后，成型环恢复至扩张状态，封堵器支架凭借自身一定的回弹性能和成型环的辅助成型，使得发生形变的封堵支架的远端盘面恢复至设计状态。成型环的近端为便于向成型环施加外力的近端结构，成型环的远端有M根连接线，M≥3，M根连接线与封堵器支架的远端盘面连接固定，M根连接线与远端盘面的M个连接点位于封堵器腰部直径的投影圆上或投影圆内；当对成型环的近端结构施加作用力时，该作用力通过成型环远端的连接线均匀分散至各连接点，实现封堵器腰部的回拉扣紧，并带动远端盘面与近端盘面相互贴合。
优选地，所述阻流膜设置成单层或设置成N层，N≥2。
优选地，当对所述成型环的所述近端结构施加作用力时，所述成型环带动所述远端盘面中心内凹，所述远端盘面内侧挤压所述封堵器腰部，从而增加所述封堵器腰部支撑。
优选地，通过所述封堵器支架上接头的通孔将所述成型环束缚至所述收缩状态，实现生物可降解封堵器的整体回收。
本发明提供的一种降落伞设计生物可降解封堵器具有如下优点：
1)使用高分子生物可降解的材料制成，在人体组织中经过一段时间后可被人体组织分解或吸收，最终缺损部分由人体自身组织构成，实现无异物封堵，对于儿童而言，收益尤为明显。
2)得益于封堵器整体材料的原因，对比金属封堵器，本发明提供的封堵器更加柔软，植入人体后封堵器对缺损组织及周围产生更小的摩擦和磨损。
3)封堵器特殊的成型环设计，能够完成封堵器左右盘面的预期成型，补偿封堵器材料回弹性不佳的问题，最终实现与缺损组织顺滑贴合达到封堵效果。
4)本发明提供的封堵器具有回收功能，能够尽可能地解决临床上可能出现的一些异常情况，实现对患者最优的治疗。
5)本发明提供的封堵器手术操作简单，对比以往金属封堵器的手术操作过程，在未提高手术操作复杂度的前提下，实现了更优的封堵治疗。
附图说明
图1为本发明提供的一种降落伞设计生物可降解封堵器的结构示意图；
图2至图4为不同结构形式的降落伞设计生物可降解封堵器的示意图；
图5为本发明提供的一种降落伞设计生物可降解封堵器在缺损部位成型后的示意图；
图6A及图6B为第一种绑线形式的成型环示意图；
图7A及图7B为第二种绑线形式的成型环示意图；
图8A及图8B为第三种绑线形式的成型环示意图；
图9为本发明提供的一种降落伞设计生物可降解封堵器在输送鞘管内的示意图。
具体实施方式
下面结合具体实施例，进一步阐述本发明。应理解，这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解，在阅读了本发明讲授的内容之后，本领域技术人员可以对本发明作各种改动或修改，这些等价形式同样落于本申请所附权利要求书所限定的范围。
本发明提供的一种降落伞设计生物可降解封堵器由高分子聚合物材料制成，该种材料在生物组织内具有可降解的性能，最终分解成人体无害、可被人体吸收或可被人体代谢的物质。
结合图1，本发明包括封堵器支架1、阻流膜2及成型环4。封堵器支架1可由丝材编织而成，也可由管材雕刻而成，或者通过3D打印的方式制作而成。将靠近人体的方向定义为近端，将原理人体的方向定义为远端。封堵器支架1远端为远端盘面、近端为近端盘面，封堵器支架位于远端盘面与近端盘面中间的部分为封堵器腰部。同时，封堵器支架1近端有一个带有通孔的接头。
为了将本发明提供的解封堵器输送至预定位置，在封堵器支架1或阻流膜2上的恰当位置设置有显影标记3，通过该显影标记3可以准确掌握本发明提供的解封堵器的输送路径和位置。显影标记3的具体位置由本领域技术人员根据需要设定，此处不做限制。
阻流膜2位于封堵器支架1中，本领域技术人员根据需要可设置单层的阻流 膜2，也可以设置多层的阻流膜2。阻流膜2分别分布在封堵器支架1的近端及远端，位于近端的阻流膜2中间有一个通孔。
成型环4采用降落伞形式，即其整体在无束缚或无受力状态下是一个类圆形或椭圆的形状，此时，成型环4处于扩张状态。同时，成型环4的近端是一个环状结构。与降落伞类似的是，成型环4可以收起至收缩状态，也可以展开至扩张状态。通过成型环4的环状结构对成型环4施加外力后，使得成型环4由扩张状态变化至收缩状态。本实施例中，通过成型线5牵引成型环4，实现对成型环4施加外力。处于收缩状态的成型环4可以顺利通过封堵器支架1近端接头的通孔以及位于近端的阻流膜2中间的通孔。由于通孔对成型环4的束缚作用，成型环4在通过通孔时始终保持收缩状态。成型环4部分或全部通过通孔解除限制后，会恢复原有形状。成型环4远端是连接线，连接线与封堵器支架1的远端盘面连接。成型环4与远端盘面有多个(3个以上)连接点，各连接点位于封堵器腰部直径的投影圆上或投影圆内。例如：成型环4含4根连接线，成型环4与远端盘面连接点位于封堵器腰部直径的投影圆上；成型环4含8根连接线，成型环4与远端盘面连接点位于远端盘面中心环线上；成型环4含8根连接线，成型环4与远端盘面连接点位于封堵器腰部直径的投影圆上，8根连接线间呈经纬编制，这种设计可以增强连接线的成型效果，避免连接线之间缠绕和扭结等问题。
本领域技术人员可以根据需要选择成型环4的绑线形式，图6A及图6B、图7A及图7B、图8A及图8B示意性地给出了三种不同的绑线形式。成型环的绑线形式为成型环与封堵器支架的固定样式，如图6A、图6B、图7A、图7B、图8A及图8B所示，有不同的编织连接方式。
封堵器支架1由高分子材料制成，对比金属材料，高分子材料的记忆回弹性会相对比较弱一些。封堵器支架1在通过输送鞘管被输送入体内后，由于高分子材料的记忆回弹性相对较弱，因此封堵器支架1无法恢复至设计形状。为了解决该问题，本发明在封堵器支架1内植入成型环4，部分处于扩张状态或全部处于扩张状态的成型环4形成对封堵器支架1的支撑作用，帮助封堵器支架1恢复至设计形状，以弥补高分子材料所造成的记忆回弹性相对较弱的缺陷。
当对成型环4的环状结构施加作用力时，该作用力通过成型环4的连接线均匀分散至各连接点，实现整个封堵器腰部的回拉扣紧，能够最大程度地补偿由于 材料原因的回弹不佳，实现封堵器的预期成型。
该种连接方式能够让封堵器支架1的远端盘面尽可能地恢复至预期形状，而不使远端盘面鼓起或者在缺损位置贴壁不佳，造成后期该封堵位置厚度加厚。同时，远端盘面与近端盘面的相互贴合可减少并发症残余分流的发生，大大提高器械治疗的封堵效果。
该种连接方式也能够增加封堵器腰部支撑性能，成型环4带动远端盘面中心内凹，远端盘面内侧挤压封堵器腰部，从而增加封堵器腰部支撑，实现封堵器稳定固定。
该种连接方式能够增加封堵器远端盘面与近端盘面间夹持性能，成型环4的连接线的各连接点位于封堵器腰部直径的投影圆上或投影圆内，可以增加远端盘面盘面刚性，同时带动远端盘面与近端盘面相互贴合，增加两盘面的夹持力，实现封堵器稳定固定。
本发明提供的封堵器还具备可回收的功能。当植入封堵器未完全释放，行造影术观察即刻封堵效果的时候，如果观测到封堵效果不佳或者选择封堵器不适合，可以进行封堵器的回收并更换更加适合的封堵器。封堵器植入人体，成型环4通过位于封堵器支架1近端的接头的通孔，位于通孔外部或一半卡在通孔内，成型环4由于具有一定的弹性，会一定程度上恢复到原先的圆形或椭圆形状。此时封堵器完全成型，封堵器的近端盘面与远端盘面完全扣紧，与缺损部位的组织顺滑贴合，并且具备一定的锁紧强度。但需要回收封堵器的时候，此时，输送装置未与位于封堵器支架1近端的接头分离，往后牵拉输送装置，但牵拉力大于成型环4的锁紧强度时，成型环4会变形通过接头的通孔，由于通孔对成型环4的束缚作用，成型环4会保持收缩状态，重新被拉回至封堵器支架内部。继续对输送装置往后施加回撤力，直至整个封堵器被拉回至输送鞘管内并最终撤出体外。

Claims (4)

  1. 一种降落伞设计生物可降解封堵器，将靠近人体的一端定义为近端，将远离人体的一端定义为远端，其特征在于，包括内设有阻流膜的封堵器支架及状态可变的成型环，封堵器支架、阻流膜及成型环均由在生物组织内具有可降解性能的高分子聚合物材料制成，其中：
    封堵器支架远端为远端盘面、近端为近端盘面，封堵器支架位于远端盘面与近端盘面中间的部分为封堵器腰部，封堵器支架的近端设有接头，成型环通过接头的通孔进入封堵器支架内；
    成型环的状态在收缩状态与扩张状态之间切换；在无束缚或无受力状态下，成型环处于扩张状态，此时封堵器未成型，封堵器可在细长的输送鞘管内输送；在施加外力后，成型环由扩张状态向收缩状态变化，处于收缩状态的成型环可以通过封堵器支架上接头的通孔；当外力撤除后，成型环恢复至扩张状态，封堵器支架凭借自身一定的回弹性能和成型环的辅助成型，使得发生形变的封堵支架的远端盘面恢复至设计状态；成型环的近端为便于向成型环施加外力的近端结构，成型环的远端有M根连接线，M≥3，M根连接线与封堵器支架的远端盘面连接固定，M根连接线与远端盘面的M个连接点位于封堵器腰部直径的投影圆上或投影圆内；当对成型环的近端结构施加作用力时，该作用力通过成型环远端的连接线均匀分散至各连接点，实现封堵器腰部的回拉扣紧，并带动远端盘面与近端盘面相互贴合。
  2. 如权利要求1所述的一种降落伞设计生物可降解封堵器，其特征在于，所述阻流膜设置成单层或设置成N层，N≥2。
  3. 如权利要求1所述的一种降落伞设计生物可降解封堵器，其特征在于，当对所述成型环的所述近端结构施加作用力时，所述成型环带动所述远端盘面中心内凹，所述远端盘面内侧挤压所述封堵器腰部，从而增加所述封堵器腰部支撑。
  4. 如权利要求1所述的一种降落伞设计生物可降解封堵器，其特征在于，通过所述封堵器支架上接头的通孔将所述成型环束缚至所述收缩状态，实现生物可降解封堵器的整体回收。
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