WO2018166377A1 - New occluding device for septal defect - Google Patents

New occluding device for septal defect Download PDF

Info

Publication number
WO2018166377A1
WO2018166377A1 PCT/CN2018/078145 CN2018078145W WO2018166377A1 WO 2018166377 A1 WO2018166377 A1 WO 2018166377A1 CN 2018078145 W CN2018078145 W CN 2018078145W WO 2018166377 A1 WO2018166377 A1 WO 2018166377A1
Authority
WO
WIPO (PCT)
Prior art keywords
septal defect
atrial septal
bracket body
occluder
stent
Prior art date
Application number
PCT/CN2018/078145
Other languages
French (fr)
Chinese (zh)
Inventor
刘云奇
殷胜利
郭少成
杨习锋
曾晨光
张希
Original Assignee
广州新诚生物科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 广州新诚生物科技有限公司 filed Critical 广州新诚生物科技有限公司
Publication of WO2018166377A1 publication Critical patent/WO2018166377A1/en

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • A61B2017/00575Implements 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
    • A61B2017/00588Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • A61B2017/00575Implements 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
    • A61B2017/00601Implements entirely comprised between the two sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • A61B2017/00575Implements 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
    • A61B2017/00606Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect

Definitions

  • the invention relates to the technical field of medical instruments, in particular to a novel atrial septal defect occluder.
  • Atrial septal defect is a common congenital heart disease in the clinic.
  • the lesion is characterized by the failure of the atrial septum between the left and right atrium to close normally, and the blood flowing between the left atrium and the right atrium.
  • the defect of the septum is mainly formed during the growth and development of the fetus, and the development of the heart is affected by certain factors, thereby forming atrial septal defect.
  • For patients with atrial septal defect because the pressure of the left atrium is higher than that of the right atrium, part of the blood in the left atrium flows to the right atrium through the atrial septal defect, resulting in an increase in the burden of the right heart system, causing right ventricular hypertrophy and pulmonary circulation.
  • Increased, long-term presence of atrial septal defect can cause pulmonary hypertension, congestive heart failure, arrhythmia, stroke, dizziness, fainting and other diseases.
  • the inventors of the present invention conducted in-depth research and analysis on atrial septal defect, and continuously carried out experiments to develop a novel atrial septal defect occluder, which has a simple structure and can adapt to atrial septal defect of different anatomical forms and is difficult to be used. Residual leakage occurred during and after surgery.
  • the present invention provides a novel atrial septal defect occluder comprising a thin film barrier layer, a first stent body, a second stent body, a first fixed connector and a second fixed connector, wherein
  • the first bracket body and the second bracket body are woven from a compressible deformable memory metal alloy wire, wherein two ends of the memory metal alloy wire in the first bracket body are fixedly connected to the front end of the first fixed connecting member and a front end of the second fixing connector, the two ends of the memory metal alloy wire in the second bracket body are fixedly connected to the rear end of the first fixing connector and the rear end of the second fixing connector respectively;
  • the first fixing connector and The second fixing connector is a cylindrical structure and the front end of the first fixing connector and the rear end of the second fixing connector are provided with internal threads for connecting the conveying system;
  • the film barrier layer is built into the first bracket body and the second bracket body in.
  • the type of the internal thread matches the type of the threaded structure of the delivery system of the occluder of the present invention during the treatment of the atrial septal defect
  • the delivery system may be An occluder delivery device conventionally used in the art.
  • the novel atrial septal defect occluder of the present invention is connected to the delivery system, and the occluder is delivered to the atrial septal defect through the delivery system. Due to the characteristics of the memory metal alloy, the first stent body and the second stent The stent body returns to a predetermined shape to clamp the edge of the atrial septal defect, closes the atrial septal defect, and then releases the occluder to end the operation.
  • the novel atrial septal defect occluder of the present invention avoids residual leakage due to the formation of a large clamping force between the first stent body and the second stent body, and improves the existing occluder due to having a fixed waist structure. Unable to clamp the edge of the atrial septal defect.
  • the first fixed connector and the second fixed connector have a length of 1 mm to 3 mm, preferably 1 mm to 2 mm. If the length of the first fixed connecting piece and the second fixed connecting piece is too small, the number of internal thread turns in the inner part is too small, which may cause the connection with the conveying system to be weak and the risk of the occluder and the conveying system falling off during the operation. Conversely, if the length of the first fixed connector and the second fixed connector are too large, the risk of local thrombus formation on the surface of the occluder is increased, and the first stent body and the second stent body are easily restored to a predetermined shape. When the distance between the first fixed connector and the second fixed connector is too small, the first bracket body and the second bracket body are affected to clamp the soft edge of the atrial septal defect.
  • the first fixed connecting piece and the second fixed connecting piece have an inner diameter of 1-2 mm if the inner diameter of the first fixed connecting piece and the second fixed connecting piece are If it is too small, the connection between the occluder and the fixing rod is not reliable; conversely, if the inner diameters of the first fixed connecting piece and the second fixed connecting piece are too large, the occluder may be oversized after being folded and folded.
  • the thin film barrier layer is composed of a high biocompatibility high material such as polylactic acid, polyglycolic acid and polyanhydride.
  • the thin film barrier layer is composed of a polymer material having good biocompatibility, which can significantly improve the biocompatibility of the occluder.
  • the thin film barrier layer is a biofilm having a uniform thickness and a thickness of 0.1 mm to 0.2 mm. If the thickness of the thin film barrier layer is too small, the thin film barrier layer is easily broken due to the impact of blood flow; conversely, if the thickness of the thin film barrier layer is too large, the weight of the thin film barrier layer is increased, resulting in the weight of the occluder Also increased, is not conducive to the closure of atrial septal defect.
  • the predetermined shape of the first stent body and the second stent body is an intermediate convex lantern shape.
  • the first bracket body and the second bracket body are restored to a preset lantern shape, and the first bracket body and the second bracket body of the lantern form a large clamping force.
  • the entire occluder can better clamp the edge of the atrial septal defect and close the atrial septal defect.
  • the first stent body and the second stent body are restored to the longitudinal direction of the intermediate convex lantern-shaped intermediate convex lantern-shaped intermediate projection.
  • the cross section is circular and its diameter is 5mm-50mm.
  • the novel atrial septal defect occluder of the present invention can select a first stent body and a second stent body of an appropriate size according to the size of the atrial septal defect estimated in advance by the cooperation of X-ray, angiography and color Doppler ultrasound, Better achieve the perfect fit between the occluder and the atrial septal defect.
  • the number of memory metal alloy wires in the first stent body and the second stent body is 20-30. If the number of memory metal alloy wires in the first bracket body and the second bracket body is too small, the first bracket body and the second bracket body cannot form a sufficient clamping force to clamp the edge of the atrial septal defect to close the room. Interval defect, prone to shedding phenomenon; conversely, if the number of memory metal alloy wires in the first stent body and the second stent body is too large, the weight of the occluder will increase significantly, which also increases the risk of shedding. .
  • the diameter of the memory metal alloy wire in the first stent body and the second stent body is 0.1-0.2 mm. If the diameter of the memory metal alloy wire in the first bracket body and the second bracket body is too small, the first bracket body and the second bracket body are too thin and have insufficient strength due to the memory metal alloy wire being too thin, and there is insufficient support. Force, so that the entire occluder is easy to shape; conversely, if the diameter of the memory metal alloy wire in the first stent body and the second stent body is too large, the weight of the occluder will increase significantly, which increases the risk of shedding. .
  • the first stent body and the second stent body are compressed into a cylindrical mesh structure, and the structure can easily enter the interatrial septum when in use. Defect.
  • the surfaces of the first fixed connector, the second fixed connector, the first bracket body and the second bracket body are plated with a carbon thin film layer, thereby improving the whole
  • the anti-corrosion effect of the occluder prevents metal ions from entering the blood and effectively controls the formation of blood clots, making the use safer.
  • the thin film barrier layer is respectively attached to the wire of the first stent body and/or the second stent body to be clamped on the first stent body and/or the second The space enclosed by the wire of the bracket body.
  • the novel atrial septal defect occluder of the present invention provides a new idea of closing atrial septal defect, effectively clamping the edge of the atrial septal defect with the clamping force between the occluder, instead of having an existing occluder
  • the fixed waist size closes the atrial septal defect by clamping the edge of the atrial septal defect.
  • first and second do not represent a specific number and order, but are merely used to distinguish names.
  • the present invention has the following beneficial effects and advantages:
  • the novel atrial septal defect occluder of the invention has technical advancement and is an unprecedented innovative design; and the unique structure is far from the comparison of the existing occluder, and the structure is firm and the shape is reasonable. Appropriate elasticity, easy implantation and easy positioning, it is very suitable for standardized production and large-scale application;
  • the novel atrial septal defect occluder of the present invention provides a new idea of closing atrial septal defect, and a large clamping force is formed between the first stent body and the second stent body to close the atrial septal defect, thereby avoiding Residual leakage improves the existing occluder because it has a fixed waist structure and cannot clamp the edge of the atrial septal defect;
  • the novel atrial septal defect occluder of the present invention can select a first stent body and a second stent of a suitable size according to the size of the atrial septal defect estimated in advance by the cooperation of X-ray, angiography and color Doppler ultrasound.
  • Body in order to better achieve the fit of the occluder and the atrial septal defect, there will be no model mismatch, the occluder size is significantly larger than the atrial septal defect, avoiding material waste, thereby reducing costs.
  • FIG. 1 is a schematic structural view of a novel atrial septal defect occluder in a compressed state according to the present invention
  • FIG. 2 is a schematic structural view of another perspective view of the novel atrial septal defect occluder in the compressed state of FIG. 1;
  • FIG. 3 is a schematic structural view of the novel atrial septal defect occluder of FIG. 1 after restoring shape;
  • FIG. 4 is a structural schematic view of another perspective view of the restored shape of the novel atrial septal defect occluder of FIG. 1.
  • FIG. 1 is a schematic structural view of a novel atrial septal defect occluder in a compressed state according to the present invention
  • FIG. 2 is a structural schematic view of another perspective view of the novel atrial septal defect occluder in a compressed state of FIG.
  • FIG. 4 is a structural schematic view of another perspective of the restored shape of the atrial septal defect occluder of FIG.
  • the novel atrial septal defect occluder of the present invention includes a first stent body 3, a second stent body 4, a first fixation connector 1 and a second fixation connector 2, wherein the first stent body 3
  • the second bracket body 4 is woven from the compressible and deformable memory metal alloy wire 6, wherein the two ends of the memory metal alloy wire 6 in the first bracket body 3 are fixedly connected to the front end of the first fixed connecting member 1, respectively.
  • the front end of the second fixing connector 2 the two ends of the memory metal alloy wire 6 in the second bracket body 4 are fixedly connected to the rear end of the first fixing connector 1 and the rear end of the second fixing connector 2, respectively.
  • one end of the memory metal alloy wire 6 in the first bracket body 3 is fixedly connected to the front end of the first fixed connecting member 1, and the other end is fixedly connected to the front end of the second fixed connecting member 2, and the second bracket body 4 is One end of the memory metal alloy wire 6 is fixedly connected to the rear end of the first fixed connection member 1 and the other end is fixedly connected to the rear end of the second fixed connection member 2; the first fixed connection member 1 and the second fixed connection member 2 a cylindrical structure and a front end and a second of the first fixed connector 1
  • the rear end of the fixed connecting member 2 is provided with an internal thread 5 for connecting the conveying system.
  • the internal thread 5 is disposed at the front end of the first fixed connecting member 1 and the rear end of the second fixed connecting member 2; however, the present invention
  • the occluder further includes a thin film barrier layer, but not shown in the drawings, wherein the thin film barrier layer is built into the first stent body 3 and the second stent body 4.
  • the compressed shape of the first bracket body 3 and the second bracket body 4 is a cylindrical net body structure, so that the entire occluder is cylindrical in a compressed state. This structure makes it easy to enter the atrial septal defect when in use.
  • the predetermined shape of the first bracket body 3 and the second bracket body 4 is an intermediate raised lantern shape.
  • the first bracket body 3 and the second bracket body 4 are restored to a predetermined lantern shape, and the first bracket body 3 and the second bracket body 4 formed in a lantern shape are formed larger.
  • the clamping force enables the entire occluder to better clamp the atrial septal defect edge and close the atrial septal defect.
  • the memory metal alloy wires 6 in the first stent body 3 and the second stent body 4 are all 25, but the number of the memory metal alloy wires 6 may be other numbers, preferably in the range of 20-30. . If the number of memory metal alloy wires in the first bracket body 3 and the second bracket body 4 is too small, the first bracket body 3 and the second bracket body 4 cannot form a sufficient clamping force to clamp the atrial septal defect. The edge is closed in the closed atrial septum and is prone to shedding. On the contrary, if the number of memory metal alloy wires in the first stent body 3 and the second stent body 4 is too large, the weight of the occluder is significantly increased. It also increases the risk of shedding.
  • the memory metal alloy wire 6 in the first stent body 3 and the second stent body 4 is uniformly fixedly connected to the first fixed connector 1 And the second fixed connector 2 is attached.
  • the longitudinal section of the intermediate convex lantern-shaped intermediate protrusion is circular, and the diameter thereof is 5 mm to 50 mm.
  • the novel atrial septal defect occluder of the present invention has a relatively wide range of sizes, and can be selected according to the size of the atrial septal defect estimated by X-ray, angiography, and color Doppler in advance.
  • the stent body 3 and the second stent body 4 are better to achieve a perfect fit between the occluder and the atrial septal defect.
  • the diameter of the memory metal alloy wire 6 in the first holder body 3 and the second holder body 4 is 0.1 to 0.2 mm. If the diameter of the memory metal alloy wire 6 in the first holder body 3 and the second holder body 4 is too small, the first holder body 3 and the second holder body 4 are too thin and the strength is too small because the memory metal alloy wire 6 is too thin. , there is not enough supporting force, so that the entire occluder is easy to shape; conversely, if the diameter of the memory metal alloy wire 6 in the first bracket body 3 and the second bracket body 4 is too large, the weight of the occluder is Will increase significantly, will increase the risk of shedding.
  • first fixed connector 1, the second fixed connector 2, the first bracket body 3 and the second bracket body 4 are plated with a carbon film layer on the surface, thereby improving the anticorrosion effect of the entire occluder and preventing metal ions. Entering the blood, effectively controlling the formation of blood clots, making it safer to use.
  • first fixed connection 1 and the second fixed connection 2 have a length of 1 mm to 3 mm, preferably 1 mm to 2 mm. If the lengths of the first fixed connecting piece 1 and the second fixed connecting piece 2 are too small, the number of internal threads 5 of the inner part thereof is too small, which may cause the connection with the conveying system to be weak and the occluder and the conveying system exist during the operation. The risk of shedding; conversely, if the length of the first fixed connector 1 and the second fixed connector 2 is too large, the risk of local thrombosis on the surface of the occluder is increased, and the first stent body 3 and the second stent are easily caused. When the body 4 is restored to the preset shape, the distance between the first fixed connector 1 and the second fixed connector 2 is too small, which affects the soft edges of the first bracket body 3 and the second bracket body 4 that clamp the atrial septal defect.
  • the inner diameters of the first fixed connection member 1 and the second fixed connection member 2 are 1 mm to 2 mm, and if the inner diameters of the first fixed connection member 1 and the second fixed connection member 2 are too small, the occluder is The connection between the fixing rods is not reliable; conversely, if the inner diameters of the first fixed connecting piece 1 and the second fixed connecting piece 2 are too large, the size of the occluder may be too large after being folded and folded. .
  • the thin film barrier layer it is composed of a high biocompatibility high material such as polylactic acid, polyglycolic acid, and polyanhydride.
  • the thin film barrier layer is composed of a polymer material having good biocompatibility, which can significantly improve the biocompatibility of the occluder.
  • the thin film barrier layer is a biofilm having a uniform thickness and a thickness of 0.1 mm to 0.2 mm. If the thickness of the thin film barrier layer is too small, the thin film barrier layer is easily broken due to the impact of blood flow; conversely, if the thickness of the thin film barrier layer is too large, the weight of the thin film barrier layer is increased, resulting in the weight of the occluder Also increased, is not conducive to the closure of atrial septal defect.
  • the novel atrial septal defect occluder of the present invention is connected to the delivery system, and the occluder is delivered to the atrial septal defect through the delivery system. Due to the characteristics of the memory metal alloy, the first stent body and the second stent The stent body returns to a predetermined shape to clamp the edge of the atrial septal defect, closes the atrial septal defect, and then releases the occluder to end the operation.

Abstract

Provided is a new occluding device for septal defect comprising a barrier layer, a first stent (3), a second stent (4), a first fixed connecting piece (1) and a second fixed connecting piece (2). According to the present invention, the new occluding device for septal defect opens up new perspectives for closing a septal defect thanks to the occluding force applied between the septal defect to clamp the edges efficiently. Unlike the prior art where occluding devices have a fixed dimension for the wraist, said new occluding device occludes the septal defect by clamping the edges thereof.

Description

一种新型房间隔缺损封堵器Novel atrial septal defect occluder 技术领域Technical field
本发明涉及医疗器械技术领域,特别地涉及一种新型房间隔缺损封堵器。The invention relates to the technical field of medical instruments, in particular to a novel atrial septal defect occluder.
背景技术Background technique
房间隔缺损是临床上常见的一种先天性心脏疾病,病变特点是左右心房之间的房间隔未能正常闭合,血液在左心房和右心房之间流动。房间隔的缺损主要形成于胎儿的生长发育过程中,由于受某种因素影响了心脏的发育,从而形成房间隔缺损。对于房间隔缺损患者来说,由于左心房的压力高于右心房,而使左心房的部分血液经房间隔缺损流至右心房,导致右心系统的负担增加,引起右心室肥大,肺循环血量增加,房间隔缺损的长期存在会造成肺动脉高压、充血性心力衰竭、心律失常、中风、头晕、昏厥等病症。Atrial septal defect is a common congenital heart disease in the clinic. The lesion is characterized by the failure of the atrial septum between the left and right atrium to close normally, and the blood flowing between the left atrium and the right atrium. The defect of the septum is mainly formed during the growth and development of the fetus, and the development of the heart is affected by certain factors, thereby forming atrial septal defect. For patients with atrial septal defect, because the pressure of the left atrium is higher than that of the right atrium, part of the blood in the left atrium flows to the right atrium through the atrial septal defect, resulting in an increase in the burden of the right heart system, causing right ventricular hypertrophy and pulmonary circulation. Increased, long-term presence of atrial septal defect can cause pulmonary hypertension, congestive heart failure, arrhythmia, stroke, dizziness, fainting and other diseases.
外科手术是治疗房间隔缺损的传统方法,然而,外科手术治疗房间隔缺损需要开胸,其具有以下缺点:手术中需要体外循环,可能造成并发症而导致死亡;创伤大,并在体表留下手术切口的伤痕;同时手术费用高昂。为了避免对房间隔缺损患者进行开胸手术,早在二十世纪六十年代医学研究者便开展了非外科手术方法治疗房间隔缺损的探讨,先后发明了多种封堵器如Rishkind、Sideris和Amplatzer封堵器,经心脏导管送入封堵器闭合房间隔缺损,达到与外科开胸手术相当的疗效,并且可以避免输血和由输血及外科手术引起的并发症。然而经临床应用发现,Rishkind和Sideris封堵器成功率低且并发症的发生率高,逐渐被淘汰,近年来临床上应用最广泛的是Amplatzer封堵器,其呈双盘片细腰状结构,具有固定的腰部大小,往往难以卡紧房间隔缺损的“软边”,从而导致术中和术后出现残余漏,以致房间隔缺损封堵失败或闭合不全,同时这种标准化的封堵器设计难以满足复杂多变的房间隔解剖形态且还易出现并发症。至于为了适应不同解剖形态的房间隔缺损而开发的其他封堵器则存在着型号复杂、不便于生产和使用及增加手术复杂性的缺陷。故而需要研发出一种生产和使用简单且能够避免术中和术后出现残余漏现象的新型封堵器Surgery is the traditional method for the treatment of atrial septal defect. However, surgical treatment of atrial septal defect requires thoracotomy, which has the following disadvantages: extracorporeal circulation is required during surgery, which may cause complications and death; trauma is large, and remains on the body surface The scar of the lower surgical incision; at the same time, the cost of surgery is high. In order to avoid thoracotomy in patients with atrial septal defect, medical researchers conducted non-surgical methods for the treatment of atrial septal defect in the 1960s, and invented various occluders such as Rishkind, Sideris and The Amplatzer occluder, which is delivered to the occluder through the cardiac catheter to close the atrial septal defect, achieves comparable efficacy to surgical thoracotomy and avoids blood transfusions and complications caused by blood transfusions and surgery. However, clinical application found that Rishkind and Sideris occluder have low success rate and high incidence of complications, and are gradually eliminated. In recent years, the most widely used clinically is the Amplatzer occluder, which has a double-disc thin waist structure. With a fixed waist size, it is often difficult to tighten the "soft edge" of the atrial septal defect, resulting in residual leakage during and after surgery, resulting in atrial septal defect failure or incomplete closure, and this standardized occluder design It is difficult to meet the complex and variable atrial anatomy and is also prone to complications. As for other occluders developed to accommodate atrial septal defects of different anatomical forms, there are drawbacks of complex models, inconvenience in production and use, and increased surgical complexity. Therefore, it is necessary to develop a new type of occluder that is simple to produce and use and can avoid residual leakage during and after surgery.
发明内容Summary of the invention
鉴于上述问题,本发明发明人对房间隔缺损进行深入研究和分析,并不断进行实验, 开发出一种新型房间隔缺损封堵器,其结构简单,能够适应不同解剖形态的房间隔缺损且不易在术中和术后出现残余漏现象。In view of the above problems, the inventors of the present invention conducted in-depth research and analysis on atrial septal defect, and continuously carried out experiments to develop a novel atrial septal defect occluder, which has a simple structure and can adapt to atrial septal defect of different anatomical forms and is difficult to be used. Residual leakage occurred during and after surgery.
为了实现上述目的,本发明提供一种新型房间隔缺损封堵器,其包括薄膜阻隔层、第一支架体、第二支架体、第一固定连接件和第二固定连接件,其特征在于,第一支架体和第二支架体由可压缩变形的记忆性金属合金丝编织而成,其中第一支架体中的记忆性金属合金丝的两端分别固定连接于第一固定连接件的前端和第二固定连接件的前端,第二支架体中的记忆性金属合金丝的两端分别固定连接于第一固定连接件的后端和第二固定连接件的后端;第一固定连接件和第二固定连接件为圆柱状结构且第一固定连接件的前端和第二固定连接件的后端设有内螺纹用以连接输送系统;薄膜阻隔层内置入第一支架体和第二支架体中。In order to achieve the above object, the present invention provides a novel atrial septal defect occluder comprising a thin film barrier layer, a first stent body, a second stent body, a first fixed connector and a second fixed connector, wherein The first bracket body and the second bracket body are woven from a compressible deformable memory metal alloy wire, wherein two ends of the memory metal alloy wire in the first bracket body are fixedly connected to the front end of the first fixed connecting member and a front end of the second fixing connector, the two ends of the memory metal alloy wire in the second bracket body are fixedly connected to the rear end of the first fixing connector and the rear end of the second fixing connector respectively; the first fixing connector and The second fixing connector is a cylindrical structure and the front end of the first fixing connector and the rear end of the second fixing connector are provided with internal threads for connecting the conveying system; the film barrier layer is built into the first bracket body and the second bracket body in.
在本发明的新型房间隔缺损封堵器中,所述内螺纹的型号与治疗房间隔缺损的手术时输送本发明封堵器的输送系统的螺纹结构的型号相匹配,所述输送系统可以为本领域中常规使用的封堵器输送装置。In the novel atrial septal defect occluder of the present invention, the type of the internal thread matches the type of the threaded structure of the delivery system of the occluder of the present invention during the treatment of the atrial septal defect, the delivery system may be An occluder delivery device conventionally used in the art.
手术时,现将本发明的新型房间隔缺损封堵器与输送系统相连接,通过输送系统将封堵器输送至房间隔缺损处,因记忆性金属合金的特性,第一支架体和第二支架体回复至预设的形状以夹紧房间隔缺损的边缘,封闭房间隔缺损,然后释放封堵器,结束手术。本发明的新型房间隔缺损封堵器由于第一支架体和第二支架体之间形成较大的夹紧力,而避免了残余漏,改善了现有封堵器由于具有固定的腰部结构而无法卡紧房间隔缺损边缘。At the time of surgery, the novel atrial septal defect occluder of the present invention is connected to the delivery system, and the occluder is delivered to the atrial septal defect through the delivery system. Due to the characteristics of the memory metal alloy, the first stent body and the second stent The stent body returns to a predetermined shape to clamp the edge of the atrial septal defect, closes the atrial septal defect, and then releases the occluder to end the operation. The novel atrial septal defect occluder of the present invention avoids residual leakage due to the formation of a large clamping force between the first stent body and the second stent body, and improves the existing occluder due to having a fixed waist structure. Unable to clamp the edge of the atrial septal defect.
优选地,在本发明的新型房间隔缺损封堵器中,所述第一固定连接件和第二固定连接件的长度为1mm-3mm,优选1mm-2mm。如果第一固定连接件和第二固定连接件的长度过小,则其内部的内螺纹圈数过少,会引起与输送系统连接不牢固而在术中存在封堵器与输送系统脱落的风险;反之,如果第一固定连接件和第二固定连接件的长度过大,则会增加封堵器表面局部血栓形成的风险,并且易导致第一支架体和第二支架体恢复至预设形状时第一固定连接件和第二固定连接件之间的距离过小,影响第一支架体和第二支架体夹紧房间隔缺损的软边。Preferably, in the novel atrial septal defect occluder of the present invention, the first fixed connector and the second fixed connector have a length of 1 mm to 3 mm, preferably 1 mm to 2 mm. If the length of the first fixed connecting piece and the second fixed connecting piece is too small, the number of internal thread turns in the inner part is too small, which may cause the connection with the conveying system to be weak and the risk of the occluder and the conveying system falling off during the operation. Conversely, if the length of the first fixed connector and the second fixed connector are too large, the risk of local thrombus formation on the surface of the occluder is increased, and the first stent body and the second stent body are easily restored to a predetermined shape. When the distance between the first fixed connector and the second fixed connector is too small, the first bracket body and the second bracket body are affected to clamp the soft edge of the atrial septal defect.
优选地,在本发明的新型房间隔缺损封堵器中,所述第一固定连接件和第二固定连接件的内径为1-2mm,如果第一固定连接件和第二固定连接件的内径过小,则所述封堵器与固定杆之间的连接不牢靠;反之,如果第一固定连接件和第二固定连接件的内径过大,会导致封堵器折叠收拢后尺寸过大。Preferably, in the novel atrial septal defect occluder of the present invention, the first fixed connecting piece and the second fixed connecting piece have an inner diameter of 1-2 mm if the inner diameter of the first fixed connecting piece and the second fixed connecting piece are If it is too small, the connection between the occluder and the fixing rod is not reliable; conversely, if the inner diameters of the first fixed connecting piece and the second fixed connecting piece are too large, the occluder may be oversized after being folded and folded.
优选地,在本发明的新型房间隔缺损封堵器中,所述薄膜阻隔层由生物相容性较好的高材料组成,如聚乳酸、聚乙醇酸和聚酸酐。所述薄膜阻隔层由生物相容性较好的高分子材料组成可以显著改善封堵器的生物相容性。Preferably, in the novel atrial septal defect occluder of the present invention, the thin film barrier layer is composed of a high biocompatibility high material such as polylactic acid, polyglycolic acid and polyanhydride. The thin film barrier layer is composed of a polymer material having good biocompatibility, which can significantly improve the biocompatibility of the occluder.
更优选地,在本发明的新型房间隔缺损封堵器中,所述薄膜阻隔层为厚度均匀的生物膜,其厚度为0.1mm-0.2mm。如果薄膜阻隔层的厚度太小,则薄膜阻隔层很容易因为血流的冲击力而破裂;反之,如果薄膜阻隔层的厚度太大,则薄膜阻隔层的重量加大,导致封堵器的重量也加大,不利于封闭房间隔缺损。More preferably, in the novel atrial septal defect occluder of the present invention, the thin film barrier layer is a biofilm having a uniform thickness and a thickness of 0.1 mm to 0.2 mm. If the thickness of the thin film barrier layer is too small, the thin film barrier layer is easily broken due to the impact of blood flow; conversely, if the thickness of the thin film barrier layer is too large, the weight of the thin film barrier layer is increased, resulting in the weight of the occluder Also increased, is not conducive to the closure of atrial septal defect.
优选地,在本发明的新型房间隔缺损封堵器中,所述第一支架体和第二支架体的预设形状为中间凸起的灯笼状。使用时,由于记忆性金属合金持续回塑,第一支架体和第二支架体恢复至预先设定的灯笼状,由于灯笼状的第一支架体和第二支架体形成较大的夹紧力而使整个封堵器能够较好的夹紧房间隔缺损边缘,封闭房间隔缺损。Preferably, in the novel atrial septal defect occluder of the present invention, the predetermined shape of the first stent body and the second stent body is an intermediate convex lantern shape. In use, since the memory metal alloy is continuously reshaped, the first bracket body and the second bracket body are restored to a preset lantern shape, and the first bracket body and the second bracket body of the lantern form a large clamping force. The entire occluder can better clamp the edge of the atrial septal defect and close the atrial septal defect.
更优选地,在本发明的新型房间隔缺损封堵器中,所述第一支架体和第二支架体恢复至中间凸起的灯笼状时中间凸起的灯笼状的中间凸起处的纵截面为圆形,且其直径为5mm-50mm。本发明的新型房间隔缺损封堵器可以根据通过在X光、动脉造影和彩超的配合下而预先估测的房间隔缺损的大小而选择合适大小的第一支架体和第二支架体,以更好地实现封堵器与房间隔缺损的完美配合。More preferably, in the novel atrial septal defect occluder of the present invention, the first stent body and the second stent body are restored to the longitudinal direction of the intermediate convex lantern-shaped intermediate convex lantern-shaped intermediate projection. The cross section is circular and its diameter is 5mm-50mm. The novel atrial septal defect occluder of the present invention can select a first stent body and a second stent body of an appropriate size according to the size of the atrial septal defect estimated in advance by the cooperation of X-ray, angiography and color Doppler ultrasound, Better achieve the perfect fit between the occluder and the atrial septal defect.
优选地,在本发明的新型房间隔缺损封堵器中,所述第一支架体和第二支架体中的记忆性金属合金丝的数量为20-30个。如果第一支架体和第二支架体中的记忆性金属合金丝的个数太少,则第一支架体和第二支架体无法形成足够的夹紧力夹紧房间隔缺损的边缘以封闭房间隔缺损,易出现脱落现象;反之,如果第一支架体和第二支架体中的记忆性金属合金丝的个数太多,则封堵器的重量则会显著增加,同样会增加脱落的风险。Preferably, in the novel atrial septal defect occluder of the present invention, the number of memory metal alloy wires in the first stent body and the second stent body is 20-30. If the number of memory metal alloy wires in the first bracket body and the second bracket body is too small, the first bracket body and the second bracket body cannot form a sufficient clamping force to clamp the edge of the atrial septal defect to close the room. Interval defect, prone to shedding phenomenon; conversely, if the number of memory metal alloy wires in the first stent body and the second stent body is too large, the weight of the occluder will increase significantly, which also increases the risk of shedding. .
优选地,在本发明的新型房间隔缺损封堵器中,所述第一支架体和第二支架体中的记忆性金属合金丝的直径为0.1-0.2mm。如果第一支架体和第二支架体中的记忆性金属合金丝的直径太小,则第一支架体和第二支架体由于记忆性金属合金丝太细而强度太小,也没有足够的支撑力,以致整个封堵器易形;反之,如果第一支架体和第二支架体中的记忆性金属合金丝的直径太大,则封堵器的重量则会显著增加,会增加脱落的风险。Preferably, in the novel atrial septal defect occluder of the present invention, the diameter of the memory metal alloy wire in the first stent body and the second stent body is 0.1-0.2 mm. If the diameter of the memory metal alloy wire in the first bracket body and the second bracket body is too small, the first bracket body and the second bracket body are too thin and have insufficient strength due to the memory metal alloy wire being too thin, and there is insufficient support. Force, so that the entire occluder is easy to shape; conversely, if the diameter of the memory metal alloy wire in the first stent body and the second stent body is too large, the weight of the occluder will increase significantly, which increases the risk of shedding. .
优选地,在本发明的新型房间隔缺损封堵器中,所述第一支架体和第二支架体压缩后的形状为筒状网体结构,该结构在使用时能够很轻松地进入房间隔缺损处。Preferably, in the novel atrial septal defect occluder of the present invention, the first stent body and the second stent body are compressed into a cylindrical mesh structure, and the structure can easily enter the interatrial septum when in use. Defect.
优选地,在本发明的新型房间隔缺损封堵器中,所述第一固定连接件、第二固定连接 件、第一支架体和第二支架体表面镀有碳薄膜层,从而提高了整个封堵器的防腐效果并防止金属离子进入血液,有效控制血栓的形成,以致使用更加安全。Preferably, in the novel atrial septal defect occluder of the present invention, the surfaces of the first fixed connector, the second fixed connector, the first bracket body and the second bracket body are plated with a carbon thin film layer, thereby improving the whole The anti-corrosion effect of the occluder prevents metal ions from entering the blood and effectively controls the formation of blood clots, making the use safer.
在本发明的新型房间隔缺损封堵器中,所述薄膜阻隔层分别贴附第一支架体和/或第二支架体的金属丝上,以夹持在第一支架体和/或第二支架体的金属丝围成的空间内。In the novel atrial septal defect occluder of the present invention, the thin film barrier layer is respectively attached to the wire of the first stent body and/or the second stent body to be clamped on the first stent body and/or the second The space enclosed by the wire of the bracket body.
本发明的新型房间隔缺损封堵器提供了封闭房间隔缺损的新思路,利用封堵器之间的夹紧力有效地夹紧房间隔缺损的边缘,而非如现有封堵器一般具有固定的腰部大小通过卡紧房间隔缺损的边缘而封闭房间隔缺损。The novel atrial septal defect occluder of the present invention provides a new idea of closing atrial septal defect, effectively clamping the edge of the atrial septal defect with the clamping force between the occluder, instead of having an existing occluder The fixed waist size closes the atrial septal defect by clamping the edge of the atrial septal defect.
需要说明的是,在本发明中,“第一”和“第二”并不代表具体的数量及顺序,仅仅是用于对名称的区分。It should be noted that in the present invention, "first" and "second" do not represent a specific number and order, but are merely used to distinguish names.
与现有技术相比,本发明具有以下有益效果和优点:Compared with the prior art, the present invention has the following beneficial effects and advantages:
(1)本发明的新型房间隔缺损封堵器具有技术进步性,是一种前所未有的创新设计;且独特的结构更是远非现有封堵器所比拟的,同时结构牢固、形态合理、弹性适当、植入方便、定位容易,非常适合标准化生产和大规模应用;(1) The novel atrial septal defect occluder of the invention has technical advancement and is an unprecedented innovative design; and the unique structure is far from the comparison of the existing occluder, and the structure is firm and the shape is reasonable. Appropriate elasticity, easy implantation and easy positioning, it is very suitable for standardized production and large-scale application;
(2)本发明的新型房间隔缺损封堵器提供了封闭房间隔缺损的新思路,利用第一支架体和第二支架体之间形成较大的夹紧力封闭房间隔缺损,而避免了残余漏,改善了现有封堵器由于具有固定的腰部结构而无法卡紧房间隔缺损边缘;(2) The novel atrial septal defect occluder of the present invention provides a new idea of closing atrial septal defect, and a large clamping force is formed between the first stent body and the second stent body to close the atrial septal defect, thereby avoiding Residual leakage improves the existing occluder because it has a fixed waist structure and cannot clamp the edge of the atrial septal defect;
(3)本发明的新型房间隔缺损封堵器可以根据通过在X光、动脉造影和彩超的配合下而预先估测的房间隔缺损的大小而选择合适大小的第一支架体和第二支架体,以更好地实现封堵器与房间隔缺损的配合,不会出现型号不符,封堵器大小明显大于房间隔缺损的现象,避免了材料浪费,从而降低了成本。(3) The novel atrial septal defect occluder of the present invention can select a first stent body and a second stent of a suitable size according to the size of the atrial septal defect estimated in advance by the cooperation of X-ray, angiography and color Doppler ultrasound. Body, in order to better achieve the fit of the occluder and the atrial septal defect, there will be no model mismatch, the occluder size is significantly larger than the atrial septal defect, avoiding material waste, thereby reducing costs.
附图说明DRAWINGS
附图是用来提供对本发明的进一步理解,并且构成说明书的一部分,与下面的具体实施方式一起用于解释本发明,但并不构成对本发明的限制。The drawings are intended to provide a further understanding of the invention, and are intended to be a
图1为本发明的新型房间隔缺损封堵器压缩状态下的结构示意图;1 is a schematic structural view of a novel atrial septal defect occluder in a compressed state according to the present invention;
图2为图1中的压缩状态下的新型房间隔缺损封堵器的另一视角的结构示意图;2 is a schematic structural view of another perspective view of the novel atrial septal defect occluder in the compressed state of FIG. 1;
图3为图1中的新型房间隔缺损封堵器恢复形状后的结构示意图;3 is a schematic structural view of the novel atrial septal defect occluder of FIG. 1 after restoring shape;
图4为图1中的新型房间隔缺损封堵器恢复形状的另一视角的结构示意图。4 is a structural schematic view of another perspective view of the restored shape of the novel atrial septal defect occluder of FIG. 1.
附图标记:Reference mark:
1           第一固定连接件;1 first fixed connection;
2           第二固定连接件;2 second fixed connection;
3           第一支架体;3 first bracket body;
4           第二支架体;4 second bracket body;
5           内螺纹;5 internal thread;
6           记忆性金属合金丝。6 Memory metal alloy wire.
具体实施方式detailed description
在下文的具体实施方式中,将参照构成本说明书一部分的附图。在不偏离在此展示的发明主题的原理和范围的情况下,在本文中大致描述的以及附图中所图示的本发明的各方面可以在宽泛的配置变化中进行排列、替换、组合和分拆,所有这些排列、替换、组合和分拆均落入本发明的范围之内。In the following detailed description, reference will be made to the accompanying drawings that form a part of this specification. The aspects of the invention, which are generally described herein and illustrated in the drawings, may be arranged, substituted, combined, and in a broad configuration variation without departing from the spirit and scope of the inventive subject matter. It is intended that all such permutations, substitutions, combinations and divisions fall within the scope of the invention.
需要说明的是,在本说明书的描述中,术语“前”、“后”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或单元必须具有特定的方向、以特定的方位构造和操作,因此,不能理解为对本发明的限制。It should be noted that, in the description of the present specification, the orientation or positional relationship of the terms "front", "rear" and the like is based on the orientation or positional relationship shown in the drawings, and is merely for convenience of description of the present invention and simplified description. Rather than indicating or implying that the device or unit referred to has a particular orientation, construction and operation in a particular orientation, it is not to be construed as limiting the invention.
除非另有定义,本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的,不是旨在于限制发明。All technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs, unless otherwise defined. The terminology used in the description of the present invention is for the purpose of describing particular embodiments and is not intended to limit the invention.
下面结合附图和具体实施方式对本发明的具体实施方式作进一步说明。The specific embodiments of the present invention are further described below in conjunction with the drawings and specific embodiments.
图1为本发明的新型房间隔缺损封堵器压缩状态下的结构示意图,图2为图1中的压缩状态下的新型房间隔缺损封堵器的另一视角的结构示意图,图3为本发明的新型房间隔缺损封堵器恢复形状后的结构示意图,图4为图3中的房间隔缺损封堵器恢复形状的另一视角的结构示意图。结合图1-4可知,本发明的新型房间隔缺损封堵器包括第一支架体3、第二支架体4、第一固定连接件1和第二固定连接件2,其中第一支架体3和第二支架体4由可压缩变形的记忆性金属合金丝6编织而成,其中第一支架体3中的记忆性金属合金丝6的两端分别固定连接于第一固定连接件1的前端和第二固定连接件2的前端,第二支架体4中的记忆性金属合金丝6的两端分别固定连接于第一固定连接件1的后端和第二固定连接件2的后端,即第一支架体3中的记忆性金属合金丝6的一端固定连接于第一固定连接件1 的前端,而另一端固定连接于第二固定连接件2的前端,第二支架体4中的记忆性金属合金丝6的一端固定连接于第一固定连接件1的后端,而另一端固定连接于第二固定连接件2的后端;第一固定连接件1和第二固定连接件2为圆柱状结构且第一固定连接件1的前端和第二固定连接件2的后端设有内螺纹5用以连接输送系统,在本实施例中内螺纹5设置于第一固定连接件1的前端和第二固定连接件2的后端;然而本发明封堵器还包括薄膜阻隔层但图中未示出,其中薄膜阻隔层内置入第一支架体3和第二支架体4中。1 is a schematic structural view of a novel atrial septal defect occluder in a compressed state according to the present invention, and FIG. 2 is a structural schematic view of another perspective view of the novel atrial septal defect occluder in a compressed state of FIG. The structural schematic diagram of the novel atrial septal defect occluder after restoration of the shape, and FIG. 4 is a structural schematic view of another perspective of the restored shape of the atrial septal defect occluder of FIG. As can be seen in conjunction with Figures 1-4, the novel atrial septal defect occluder of the present invention includes a first stent body 3, a second stent body 4, a first fixation connector 1 and a second fixation connector 2, wherein the first stent body 3 And the second bracket body 4 is woven from the compressible and deformable memory metal alloy wire 6, wherein the two ends of the memory metal alloy wire 6 in the first bracket body 3 are fixedly connected to the front end of the first fixed connecting member 1, respectively. And the front end of the second fixing connector 2, the two ends of the memory metal alloy wire 6 in the second bracket body 4 are fixedly connected to the rear end of the first fixing connector 1 and the rear end of the second fixing connector 2, respectively. That is, one end of the memory metal alloy wire 6 in the first bracket body 3 is fixedly connected to the front end of the first fixed connecting member 1, and the other end is fixedly connected to the front end of the second fixed connecting member 2, and the second bracket body 4 is One end of the memory metal alloy wire 6 is fixedly connected to the rear end of the first fixed connection member 1 and the other end is fixedly connected to the rear end of the second fixed connection member 2; the first fixed connection member 1 and the second fixed connection member 2 a cylindrical structure and a front end and a second of the first fixed connector 1 The rear end of the fixed connecting member 2 is provided with an internal thread 5 for connecting the conveying system. In the present embodiment, the internal thread 5 is disposed at the front end of the first fixed connecting member 1 and the rear end of the second fixed connecting member 2; however, the present invention The occluder further includes a thin film barrier layer, but not shown in the drawings, wherein the thin film barrier layer is built into the first stent body 3 and the second stent body 4.
所述第一支架体3和第二支架体4压缩后的形状为筒状网体结构,使整个封堵器在压缩状态下为圆柱状。该结构在使用时能够很轻松地进入房间隔缺损处。The compressed shape of the first bracket body 3 and the second bracket body 4 is a cylindrical net body structure, so that the entire occluder is cylindrical in a compressed state. This structure makes it easy to enter the atrial septal defect when in use.
所述第一支架体3和第二支架体4的预设形状为中间凸起的灯笼状。使用时,由于记忆性金属合金持续回塑,第一支架体3和第二支架体4恢复至预先设定的灯笼状,由于灯笼状的第一支架体3和第二支架体4形成较大的夹紧力而使整个封堵器能够较好的夹紧房间隔缺损边缘,封闭房间隔缺损。The predetermined shape of the first bracket body 3 and the second bracket body 4 is an intermediate raised lantern shape. In use, since the memory metal alloy continues to be reshaped, the first bracket body 3 and the second bracket body 4 are restored to a predetermined lantern shape, and the first bracket body 3 and the second bracket body 4 formed in a lantern shape are formed larger. The clamping force enables the entire occluder to better clamp the atrial septal defect edge and close the atrial septal defect.
所述第一支架体3和第二支架体4中的记忆性金属合金丝6均为25个,但其记忆性金属合金丝6的数量还可为其他数目,优选在20-30个范围内。如果第一支架体3和第二支架体4中的记忆性金属合金丝的个数太少,则第一支架体3和第二支架体4无法形成足够的夹紧力夹紧房间隔缺损的边缘以封闭房间隔缺损,易出现脱落现象;反之,如果第一支架体3和第二支架体4中的记忆性金属合金丝的个数太多,则封堵器的重量则会显著增加,同样会增加脱落的风险。此外,为了获得较好的夹紧力以能够完全封闭房间隔缺损,所述第一支架体3和第二支架体4中的记忆性金属合金丝6均匀地固定连接于第一固定连接件1和第二固定连接件2上。The memory metal alloy wires 6 in the first stent body 3 and the second stent body 4 are all 25, but the number of the memory metal alloy wires 6 may be other numbers, preferably in the range of 20-30. . If the number of memory metal alloy wires in the first bracket body 3 and the second bracket body 4 is too small, the first bracket body 3 and the second bracket body 4 cannot form a sufficient clamping force to clamp the atrial septal defect. The edge is closed in the closed atrial septum and is prone to shedding. On the contrary, if the number of memory metal alloy wires in the first stent body 3 and the second stent body 4 is too large, the weight of the occluder is significantly increased. It also increases the risk of shedding. In addition, in order to obtain a better clamping force to completely close the atrial septal defect, the memory metal alloy wire 6 in the first stent body 3 and the second stent body 4 is uniformly fixedly connected to the first fixed connector 1 And the second fixed connector 2 is attached.
所述第一支架体3和第二支架体4恢复至中间凸起的灯笼状时中间凸起的灯笼状的中间凸起处的纵截面为圆形,且其直径为5mm-50mm。本发明的新型房间隔缺损封堵器大小在一个相对宽泛的范围内,可以根据通过在X光、动脉造影和彩超的配合下而预先估测的房间隔缺损的大小而选择合适大小的第一支架体3和第二支架体4,以更好地实现封堵器与房间隔缺损的完美配合。When the first bracket body 3 and the second bracket body 4 are restored to the intermediate convex lantern shape, the longitudinal section of the intermediate convex lantern-shaped intermediate protrusion is circular, and the diameter thereof is 5 mm to 50 mm. The novel atrial septal defect occluder of the present invention has a relatively wide range of sizes, and can be selected according to the size of the atrial septal defect estimated by X-ray, angiography, and color Doppler in advance. The stent body 3 and the second stent body 4 are better to achieve a perfect fit between the occluder and the atrial septal defect.
此外,所述第一支架体3和第二支架体4中的记忆性金属合金丝6的直径为0.1-0.2mm。如果第一支架体3和第二支架体4中的记忆性金属合金丝6的直径太小,则第一支架体3和第二支架体4由于记忆性金属合金丝6太细而强度太小,也没有足够的支撑力,以致整个封堵器易形;反之,如果第一支架体3和第二支架体4中的记忆性金属合金丝6的直径 太大,则封堵器的重量则会显著增加,会增加脱落的风险。Further, the diameter of the memory metal alloy wire 6 in the first holder body 3 and the second holder body 4 is 0.1 to 0.2 mm. If the diameter of the memory metal alloy wire 6 in the first holder body 3 and the second holder body 4 is too small, the first holder body 3 and the second holder body 4 are too thin and the strength is too small because the memory metal alloy wire 6 is too thin. , there is not enough supporting force, so that the entire occluder is easy to shape; conversely, if the diameter of the memory metal alloy wire 6 in the first bracket body 3 and the second bracket body 4 is too large, the weight of the occluder is Will increase significantly, will increase the risk of shedding.
另外,所述第一固定连接件1、第二固定连接件2、第一支架体3和第二支架体4表面镀有碳薄膜层,从而提高了整个封堵器的防腐效果并防止金属离子进入血液,有效控制血栓的形成,以致使用更加安全。In addition, the first fixed connector 1, the second fixed connector 2, the first bracket body 3 and the second bracket body 4 are plated with a carbon film layer on the surface, thereby improving the anticorrosion effect of the entire occluder and preventing metal ions. Entering the blood, effectively controlling the formation of blood clots, making it safer to use.
之外,所述第一固定连接件1和第二固定连接件2的长度为1mm-3mm,优选1mm-2mm。如果第一固定连接件1和第二固定连接件2的长度过小,则其内部的内螺纹5圈数过少,会引起与输送系统连接不牢固而在术中存在封堵器与输送系统脱落的风险;反之,如果第一固定连接件1和第二固定连接件2的长度过大,则会增加封堵器表面局部血栓形成的风险,并且易导致第一支架体3和第二支架体4恢复至预设形状时第一固定连接件1和第二固定连接件2之间的距离过小,影响第一支架体3和第二支架体4夹紧房间隔缺损的软边。In addition, the first fixed connection 1 and the second fixed connection 2 have a length of 1 mm to 3 mm, preferably 1 mm to 2 mm. If the lengths of the first fixed connecting piece 1 and the second fixed connecting piece 2 are too small, the number of internal threads 5 of the inner part thereof is too small, which may cause the connection with the conveying system to be weak and the occluder and the conveying system exist during the operation. The risk of shedding; conversely, if the length of the first fixed connector 1 and the second fixed connector 2 is too large, the risk of local thrombosis on the surface of the occluder is increased, and the first stent body 3 and the second stent are easily caused. When the body 4 is restored to the preset shape, the distance between the first fixed connector 1 and the second fixed connector 2 is too small, which affects the soft edges of the first bracket body 3 and the second bracket body 4 that clamp the atrial septal defect.
并且,所述第一固定连接件1和第二固定连接件2的内径为1mm-2mm,如果第一固定连接件1和第二固定连接件2的内径过小,则所述封堵器与固定杆之间的连接不牢靠;反之,如果第一固定连接件1和第二固定连接件2的内径过大,会导致封堵器折叠收拢后尺寸过大。。Moreover, the inner diameters of the first fixed connection member 1 and the second fixed connection member 2 are 1 mm to 2 mm, and if the inner diameters of the first fixed connection member 1 and the second fixed connection member 2 are too small, the occluder is The connection between the fixing rods is not reliable; conversely, if the inner diameters of the first fixed connecting piece 1 and the second fixed connecting piece 2 are too large, the size of the occluder may be too large after being folded and folded. .
关于所述薄膜阻隔层,其由生物相容性较好的高材料组成,如聚乳酸、聚乙醇酸和聚酸酐。所述薄膜阻隔层由生物相容性较好的高分子材料组成可以显著改善封堵器的生物相容性。Regarding the thin film barrier layer, it is composed of a high biocompatibility high material such as polylactic acid, polyglycolic acid, and polyanhydride. The thin film barrier layer is composed of a polymer material having good biocompatibility, which can significantly improve the biocompatibility of the occluder.
另外,所述薄膜阻隔层为厚度均匀的生物膜,其厚度为0.1mm-0.2mm。如果薄膜阻隔层的厚度太小,则薄膜阻隔层很容易因为血流的冲击力而破裂;反之,如果薄膜阻隔层的厚度太大,则薄膜阻隔层的重量加大,导致封堵器的重量也加大,不利于封闭房间隔缺损。Further, the thin film barrier layer is a biofilm having a uniform thickness and a thickness of 0.1 mm to 0.2 mm. If the thickness of the thin film barrier layer is too small, the thin film barrier layer is easily broken due to the impact of blood flow; conversely, if the thickness of the thin film barrier layer is too large, the weight of the thin film barrier layer is increased, resulting in the weight of the occluder Also increased, is not conducive to the closure of atrial septal defect.
手术时,现将本发明的新型房间隔缺损封堵器与输送系统相连接,通过输送系统将封堵器输送至房间隔缺损处,因记忆性金属合金的特性,第一支架体和第二支架体回复至预设的形状以夹紧房间隔缺损的边缘,封闭房间隔缺损,然后释放封堵器,结束手术。At the time of surgery, the novel atrial septal defect occluder of the present invention is connected to the delivery system, and the occluder is delivered to the atrial septal defect through the delivery system. Due to the characteristics of the memory metal alloy, the first stent body and the second stent The stent body returns to a predetermined shape to clamp the edge of the atrial septal defect, closes the atrial septal defect, and then releases the occluder to end the operation.
根据上述说明书的揭示和教导,本发明所属领域的技术人员还可以对上述实施方式进行变更和修改。因此,本发明并不局限于上面揭示和描述的具体实施方式,对发明的一些修改和变更也应当落入本发明的权利要求的保护范围内。此外,尽管本说明书中使用了一些特定的术语,但这些术语只是为了方便说明,并不对本发明构成任何限制。Variations and modifications of the above-described embodiments may also be made by those skilled in the art in light of the above disclosure. Therefore, the present invention is not limited to the specific embodiments disclosed and described, and the modifications and variations of the invention are intended to fall within the scope of the appended claims. In addition, although specific terms are used in the specification, these terms are merely for convenience of description and do not limit the invention.

Claims (9)

  1. 一种新型房间隔缺损封堵器,其包括薄膜阻隔层、第一支架体、第二支架体、第一固定连接件和第二固定连接件,其特征在于,第一支架体和第二支架体由可压缩变形的记忆性金属合金丝编织而成,其中第一支架体中的记忆性金属合金丝的两端分别固定连接于第一固定连接件的前端和第二固定连接件的前端,第二支架体中的记忆性金属合金丝的两端分别固定连接于第一固定连接件的后端和第二固定连接件的后端;第一固定连接件和第二固定连接件为圆柱状结构且第一固定连接件的前端和第二固定连接件的后端设有内螺纹用以连接输送系统;薄膜阻隔层内置入第一支架体和第二支架体中。A novel atrial septal defect occluder comprising a thin film barrier layer, a first stent body, a second stent body, a first fixed connector and a second fixed connector, wherein the first stent body and the second stent The body is woven by a compressible and deformable memory metal alloy wire, wherein two ends of the memory metal alloy wire in the first bracket body are fixedly connected to the front end of the first fixed connecting piece and the front end of the second fixed connecting piece, respectively. The two ends of the memory metal alloy wire in the second bracket body are respectively fixedly connected to the rear end of the first fixing connector and the rear end of the second fixing connector; the first fixing connector and the second fixing connector are cylindrical The front end of the first fixing connector and the rear end of the second fixing connector are provided with internal threads for connecting the conveying system; the film barrier layer is built into the first bracket body and the second bracket body.
  2. 根据权利要求1所述的新型房间隔缺损封堵器,其特征在于,所述第一固定连接件和第二固定连接件的长度为1mm-3mm,优选1mm-2mm,且其直径为1mm-2mm。The novel atrial septal defect occluder according to claim 1, wherein the first fixed connecting piece and the second fixed connecting piece have a length of 1 mm to 3 mm, preferably 1 mm to 2 mm, and a diameter of 1 mm. 2mm.
  3. 根据权利要求1所述的新型房间隔缺损封堵器,其特征在于,所述薄膜阻隔层为厚度均匀的生物膜,其厚度为0.1mm-0.2mm。The novel atrial septal defect occluder according to claim 1, wherein the thin film barrier layer is a biofilm having a uniform thickness and a thickness of 0.1 mm to 0.2 mm.
  4. 根据权利要求1所述的新型房间隔缺损封堵器,其特征在于,所述所述第一支架体和第二支架体的预设形状为中间凸起的灯笼状。The novel atrial septal defect occluder according to claim 1, wherein the predetermined shape of the first bracket body and the second bracket body is an intermediate convex lantern shape.
  5. 根据权利要求4所述的新型房间隔缺损封堵器,其特征在于,所述第一支架体和第二支架体恢复至中间凸起的灯笼状时中间凸起的灯笼状的中间凸起处的纵截面为圆形,且其直径为5mm-50mm。The novel atrial septal defect occluder according to claim 4, wherein the first bracket body and the second bracket body are restored to an intermediate convex lantern-shaped intermediate convex lantern-shaped intermediate protrusion The longitudinal section is circular and has a diameter of 5 mm to 50 mm.
  6. 根据权利要求1-5中任一项所述的新型房间隔缺损封堵器,其特征在于,所述第一支架体和第二支架体中的记忆性金属合金丝的数量为20-30个。The novel atrial septal defect occluder according to any one of claims 1 to 5, wherein the number of memory metal alloy wires in the first stent body and the second stent body is 20-30 .
  7. 根据权利要求1-5中任一项所述的新型房间隔缺损封堵器,其特征在于,所述第一支架体和第二支架体中的记忆性金属合金丝的直径为0.1-0.2mm。The novel atrial septal defect occluder according to any one of claims 1 to 5, wherein the diameter of the memory metal alloy wire in the first stent body and the second stent body is 0.1-0.2 mm .
  8. 根据权利要求1-5中任一项所述的新型房间隔缺损封堵器,其特征在于,所述第一固定连接件、第二固定连接件、第一支架体和第二支架体表面镀有碳薄膜层。The novel atrial septal defect occluder according to any one of claims 1 to 5, wherein the first fixed connecting piece, the second fixed connecting piece, the first bracket body and the second bracket body are plated on the surface There is a carbon film layer.
  9. 根据权利要求1-5中任一项所述的新型房间隔缺损封堵器,其特征在于,所述第一支架体和第二支架体压缩后的形状为筒状网体结构。The novel atrial septal defect occluder according to any one of claims 1 to 5, wherein the first stent body and the second stent body are compressed in a cylindrical mesh structure.
PCT/CN2018/078145 2017-03-17 2018-03-06 New occluding device for septal defect WO2018166377A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201710159779.5 2017-03-17
CN201710159779.5A CN106821427B (en) 2017-03-17 2017-03-17 A kind of Novel room is every defect plugging device

Publications (1)

Publication Number Publication Date
WO2018166377A1 true WO2018166377A1 (en) 2018-09-20

Family

ID=59143977

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2018/078145 WO2018166377A1 (en) 2017-03-17 2018-03-06 New occluding device for septal defect

Country Status (2)

Country Link
CN (1) CN106821427B (en)
WO (1) WO2018166377A1 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106821427B (en) * 2017-03-17 2019-09-20 广州新诚生物科技有限公司 A kind of Novel room is every defect plugging device
CN109758194B (en) * 2019-02-27 2020-06-26 武汉唯柯医疗科技有限公司 Atrial septum plugging device

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090076541A1 (en) * 2007-09-13 2009-03-19 Cardia, Inc. Occlusion device with centering arm
CN101450013A (en) * 2007-11-28 2009-06-10 王涛 Blocking device of heart atrial, ventricular septal defect and patent oval foramen
CN101449986A (en) * 2007-11-28 2009-06-10 王涛 Obturator of aorta ductus arteriosus
CN106821427A (en) * 2017-03-17 2017-06-13 广州新诚生物科技有限公司 A kind of Novel room is every defect plugging device

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN207323503U (en) * 2017-03-17 2018-05-08 广州新诚生物科技有限公司 A kind of Novel room is every defect plugging device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090076541A1 (en) * 2007-09-13 2009-03-19 Cardia, Inc. Occlusion device with centering arm
CN101450013A (en) * 2007-11-28 2009-06-10 王涛 Blocking device of heart atrial, ventricular septal defect and patent oval foramen
CN101449986A (en) * 2007-11-28 2009-06-10 王涛 Obturator of aorta ductus arteriosus
CN106821427A (en) * 2017-03-17 2017-06-13 广州新诚生物科技有限公司 A kind of Novel room is every defect plugging device

Also Published As

Publication number Publication date
CN106821427B (en) 2019-09-20
CN106821427A (en) 2017-06-13

Similar Documents

Publication Publication Date Title
JP6761120B2 (en) Valve fastener
CN106344100B (en) Occluder for left auricle
CN211723546U (en) Valve clamping device and clamping system thereof
US20150342612A1 (en) Left atrial appendage plugging device and delivery system
CN105662512B (en) A kind of atrial appendage occlusion implant
CN111772874A (en) Valve clamping device and clamping system thereof
CN108472031B (en) Left auricle plugging device
WO2018166377A1 (en) New occluding device for septal defect
CN2613248Y (en) Ventricular septel defect block device
WO2018145535A1 (en) Occlusion device
WO2015002625A1 (en) The occluder device for cardiovascular system
CN211583280U (en) Coated plugging device
CN211355624U (en) Atrial septal defect plugging device
CN205072925U (en) Heart atrial septal defect plugging device
CN106037879B (en) A kind of intravascular catching device and its adjusting method of adjustable section
CN203815662U (en) Semicircular eccentric ventricular septal defect occluder for periphery of membrane
CN207323503U (en) A kind of Novel room is every defect plugging device
WO2018166378A1 (en) Left auricle occluder
CN206252567U (en) Thoracic aorta covered bracket retracting device
CN2610872Y (en) Asymmetric ventricular septal defect plugging device
KR102389237B1 (en) Multifunctional occlusion device
CN110680415A (en) Coated plugging device
CN204636434U (en) Ventricular septal defect
CN211355625U (en) Single-disc type ventricular septal defect plugging device
CN204971380U (en) Congenital heart disease atrial septal defect plugging device

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18768196

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 18768196

Country of ref document: EP

Kind code of ref document: A1