CN105147350A - Self-adaptive plugging device - Google Patents
Self-adaptive plugging device Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
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Abstract
本发明提供了一种自适应封堵器,其特征在于,包括用于封堵缺损处血流的第一封堵盘和第二封堵盘,其特征在于,所述的第一封堵盘连接可拉伸和偏转的连接腰部的一端,可拉伸和偏转的连接腰部的另一端连接第二封堵盘。本发明的自适应封堵器的连接腰部可拉伸和偏转,通过连接腰部的拉伸和偏转,可以起到调节封堵器的长度和偏转角度的作用,一般主动脉和肺动脉均存在一定夹角,在可调腰部的作用下,两侧的封堵盘可分别与主动脉和动脉导管壁面良好贴合。显著提高了封堵器的回弹性、固定性、封堵效果等主要性能。
The present invention provides an adaptive occluder, which is characterized in that it includes a first occlusion disc and a second occlusion disc for occluding the blood flow at the defect, and is characterized in that the first occlusion disc One end of the stretchable and deflectable connecting waist is connected, and the other end of the stretchable and deflectable connecting waist is connected with the second occlusion disk. The connecting waist of the self-adaptive occluder of the present invention can be stretched and deflected, and the length and deflection angle of the occluder can be adjusted by stretching and deflecting the connecting waist. Under the action of the adjustable waist, the occlusion discs on both sides can fit well with the walls of the aorta and ductus arteriosus respectively. Significantly improved the main properties of the occluder such as resilience, fixity, and occlusion effect.
Description
技术领域technical field
本发明涉及一种自适应封堵器,用于治疗先天性心脏病。The invention relates to an adaptive occluder for treating congenital heart disease.
背景技术Background technique
先天性心脏病(简称先心病)是指在胚胎发育时期由于心脏及大血管的形成障碍或发育异常而引起的解剖结构异常,或出生后应自动关闭的通道未能闭合(在胎儿属正常)的情形。先心病是先天性畸形中最常见的一类,约占各种先天畸形的28%。而最为常见的先心病包括病房间隔缺损(ASD)、室间隔缺损(VSD)、动脉导管未闭(PDA)。每年我国的新生儿中患先心病人数约有15万-20万。传统的治疗方法是外科开胸手术,用补片或者缝针的技术对缺损部位进行修补,但是外科手对机体损伤较大,有一定手术并发症且留有瘢痕,将长期影响患者的身心健康和成人后的生活质量。Congenital heart disease (congenital heart disease for short) refers to the anatomical abnormality caused by the formation disorder or abnormal development of the heart and great blood vessels during the embryonic development period, or the channel that should be automatically closed after birth is not closed (it is normal in the fetus) situation. Congenital heart disease is the most common type of congenital malformation, accounting for about 28% of various congenital malformations. The most common CHDs include atrial septal defect (ASD), ventricular septal defect (VSD), and patent ductus arteriosus (PDA). Every year, about 150,000 to 200,000 newborns in my country suffer from congenital heart disease. The traditional treatment method is surgical thoracotomy, using patch or stitches to repair the defect, but the surgical hand does a lot of damage to the body, there are certain surgical complications and scars, which will affect the patient's physical and mental health for a long time and adult quality of life.
治疗先天性心脏病的封堵器的出现使这一状况有了较大改进。封堵器是一种用于治疗结构性心脏病房间隔缺损(ASD)、卵圆孔未闭封堵器(PFO)、室间隔缺损(VSD)、动脉导管未闭(PDA)等疾病的医疗器械。封堵器一般由镍钛合金丝编织而成,呈双盘状结构。利用手术将封堵器固定在缺损处,可以阻挡血流,随着内皮组织爬覆在封堵器表面,缺损愈合完全阻断血流。其腰部与缺损的直径相匹配,使封堵器不易发生移位,并降低残余分流发生率,双盘状结构在镍钛合金丝记忆性与超弹性的作用下,使封堵形变与心脏的跳动协同,进一步减少残余分流。封堵器操由输送装置(鞘管、推送钢缆、导丝等)经血管或穿刺进入心脏,在病变处释放,使手术创伤大大减少,并使先心病介入治疗的安全性和成功率得到了明显提高。The emergence of occluders for the treatment of congenital heart disease has greatly improved this situation. The occluder is a medical device used for the treatment of structural heart disease atrial septal defect (ASD), patent foramen ovale occluder (PFO), ventricular septal defect (VSD), patent ductus arteriosus (PDA) and other diseases . The occluder is generally braided by nickel-titanium alloy wire and has a double-disc structure. Using surgery to fix the occluder to the defect can block the blood flow, and as the endothelial tissue climbs over the surface of the occluder, the defect heals and completely blocks the blood flow. The waist matches the diameter of the defect, making it difficult for the occluder to displace and reduce the incidence of residual shunt. The double-disc structure, under the action of the memory and superelasticity of the nickel-titanium alloy wire, makes the occluder deformable with the heart Beat synergy to further reduce residual shunt. The occluder is operated by the delivery device (sheath, push cable, guide wire, etc.) into the heart through the blood vessel or puncture, and released at the lesion, which greatly reduces the surgical trauma and improves the safety and success rate of interventional therapy for congenital heart disease. significantly improved.
然而,目前的封堵器技术在临床应用上还有众多新的要求,主要性能上仍然有很大进步的空间。这些包括:封堵器的即刻封堵的回弹性、固定性、封堵效果等。其中回弹性是指一般封堵器由镍钛记忆合金制成,具有左右两个盘面的双盘面结构。先将封堵器拉成细长条状预装在桥管内,经由输送鞘管送入心脏内部缺损处释放后,恢复双盘面并夹在缺损的残壁上从而起到封堵作用。然而,在实际镍钛合金封堵器的使用中,由于镍钛合金材料超弹性和记忆性对温度的敏感,输送过程中产生的阻力和应变,以及血流粘性等因素,很多临床使用时将不能完全恢复双盘面的结构,而变成葫芦状等,这不仅使封堵器的封堵阻血能力大打折扣,且不能夹紧贴合缺损的残壁,从而形成大量残余分流或带来封堵器脱落风险而不得不回收更换新的封堵器,直到释放合格为止。而固定性是指封堵器在释放后,可以在缺损部位长期保持相同的位置而不移位或脱落,但双盘封堵器由于仅用双盘面夹持而固定,对于不同结构的残壁形状和厚度,统一的双盘轮廓必然不能自动适应,再加上封堵器的可能变形和回弹性不佳,双盘面的封堵器则有移位甚至脱落的风险。风度效果指用封堵器封堵缺损后,可以阻挡血液。有无残余分流在临床上是考察封堵器手术效果的主要指标之一,如果封堵器植入后利用造影剂或超声观察没有残余分流才可判断植入成功。然而双盘面的封堵器由于双盘面平行,对于宽度不等或不平整的缺损,则可能变形从而产生残余分流。However, the current occluder technology still has many new requirements in clinical application, and there is still a lot of room for improvement in the main performance. These include: the resilience, fixity, and occlusion effect of the occluder for immediate occlusion. The resilience means that the general occluder is made of nickel-titanium memory alloy and has a double-disc structure with two left and right discs. Firstly, the occluder is pulled into a slender strip and pre-installed in the bridge tube. After being delivered to the defect inside the heart through the delivery sheath and released, the double disk surface is restored and clamped on the residual wall of the defect to play a blocking role. However, in the actual use of nickel-titanium alloy occluders, due to the sensitivity of the superelasticity and memory of the nickel-titanium alloy material to temperature, the resistance and strain generated during delivery, and the viscosity of blood flow, many clinical applications will The structure of the double-disc surface cannot be completely restored, and it becomes a gourd shape, etc., which not only greatly reduces the occlusion and hemostatic ability of the occluder, but also cannot clamp and fit the defective residual wall, thus forming a large number of residual shunts or causing occlusion Due to the risk of the occluder falling off, the occluder has to be recovered and replaced with a new one until the release is qualified. The fixity means that after the occluder is released, it can maintain the same position at the defect site for a long time without shifting or falling off. However, the double-disc occluder is only fixed by the double-disk surface, and it is difficult for residual walls with different structures. The shape and thickness of the uniform double-disc contour cannot be automatically adapted. In addition to the possible deformation and poor resilience of the occluder, the double-disk occluder has the risk of shifting or even falling off. The demeanor effect means that after the defect is blocked with an occluder, blood can be blocked. The presence or absence of residual shunt is one of the main indicators for evaluating the effect of occluder surgery in clinical practice. If there is no residual shunt after implantation of the occluder, it can be judged that the implantation is successful. However, because the double-disc occluder is parallel, for defects with unequal width or unevenness, it may be deformed to produce residual shunt.
发明内容Contents of the invention
本发明的目的是提供一种具有可调腰部的封堵器,使封堵器回弹性、固定性、封堵效果等主要性能有了质的提高。本发明的封堵器结构可应用在各种封堵器上,包括ASD、VSD、PDA封堵器,有阻流膜封堵器和无阻流膜封堵器等。The purpose of the present invention is to provide an occluder with an adjustable waist, so that the main properties of the occluder such as resilience, fixity, and occlusion effect are qualitatively improved. The occluder structure of the present invention can be applied to various occluders, including ASD, VSD, PDA occluders, occluders with flow-blocking membranes and occluders without flow-blocking membranes, etc.
为了达到上述目的,本发明提供了一种自适应封堵器,包括用于封堵缺损处血流的第一封堵盘和第二封堵盘,其特征在于,所述的第一封堵盘连接可拉伸和偏转的连接腰部的一端,可拉伸和偏转的连接腰部的另一端连接第二封堵盘。In order to achieve the above object, the present invention provides an adaptive occluder, comprising a first occlusion disk and a second occlusion disk for occluding the blood flow at the defect, characterized in that the first occlusion The disk is connected to one end of the stretchable and deflectable connected waist, and the other end of the stretchable and deflectable connected waist is connected to the second occlusion disk.
优选地,所述的可拉伸和偏转的连接腰部包括球面编织网,所述的球面编织网的一端连接第一封堵盘,另一端连接第二封堵盘。Preferably, the stretchable and deflectable connecting waist includes a spherical braided mesh, one end of the spherical braided mesh is connected to the first occlusion disk, and the other end is connected to the second occlusion disk.
优选地,所述的可拉伸和偏转的连接腰部包括套环,所述的套环的一端连接第一封堵盘,另一端连接第二封堵盘。Preferably, the stretchable and deflectable connecting waist includes a collar, one end of the collar is connected to the first occlusion disk, and the other end is connected to the second occlusion disk.
优选地,所述的可拉伸和偏转的连接腰部包括弹簧,所述的弹簧的一端连接第一封堵盘,另一端连接第二封堵盘。Preferably, the stretchable and deflectable connecting waist includes a spring, one end of the spring is connected to the first occlusion disk, and the other end of the spring is connected to the second occlusion disk.
优选地,所述的可拉伸和偏转的连接腰部包括滑杆滑块组合,所述的滑杆滑块组合的一端连接第一封堵盘,另一端连接第二封堵盘。Preferably, the stretchable and deflectable connecting waist includes a slider-slider combination, one end of the slider-slider combination is connected to the first occlusion disk, and the other end is connected to the second occlusion disk.
更优选地,所述的滑杆滑块组合包括中心滑轨、上滑块、下滑块、上滑杆和下滑杆,上滑块和下滑块分别设于中心滑轨的上下两端并可独立地沿中心滑轨滑动,上滑杆穿过上滑块,上滑块可沿上滑杆滑动,下滑杆穿过下滑块,下滑块可沿下滑杆滑动,上滑杆和下滑杆分别设于上支架和下支架上,上支架和下支架分别连接上封堵盘和下封堵盘。More preferably, the slider slider assembly includes a central slide rail, an upper slider, a lower slider, an upper slider and a lower slider, and the upper slider and the lower slider are respectively arranged at the upper and lower ends of the central slide rail and Can slide independently along the center rail, the upper slider passes through the upper slider, the upper slider slides along the upper slider, the lower slider passes through the lower slider, the lower slider slides along the lower slider, the upper slider and the lower slider The rods are respectively arranged on the upper bracket and the lower bracket, and the upper bracket and the lower bracket are respectively connected with the upper blocking disk and the lower blocking disk.
优选地,所述的可拉伸和偏转的连接腰部包括由镍钛合金丝编织而成的柱状本体,所述的柱状本体的侧壁形成有至少一个凸出的环形部分。Preferably, the stretchable and deflectable connecting waist comprises a columnar body braided by nickel-titanium alloy wires, the sidewall of the columnar body is formed with at least one protruding annular portion.
优选地,所述的第一封堵盘包括镍钛合金丝编织盘;或者,所述的第一封堵盘包括至少两个固定臂,所述的固定臂为由镍钛合金管切割而成的直管或弧形弯管;或者,所述的第一封堵盘包括螺旋线骨架。Preferably, the first occlusion disk includes a nickel-titanium alloy wire braided disk; or, the first occlusion disk includes at least two fixing arms, and the fixing arms are cut from a nickel-titanium alloy tube straight pipe or curved pipe; or, the first occlusion disk includes a helical skeleton.
更优选地,所述的镍钛合金丝编织盘的内部或外部缝合固定至少一层高分子阻流膜,所述的固定臂的表面缝合固定高分子阻流膜,所述的螺旋线骨架的表面缝合固定高分子阻流膜。More preferably, the inside or outside of the nickel-titanium alloy wire braided disc is sutured to fix at least one layer of high polymer flow blocking film, the surface of the fixed arm is sutured to fix the high polymer flow blocking film, and the helical wire skeleton The surface is sutured to fix the polymer flow blocking membrane.
优选地,所述的第二封堵盘包括镍钛合金丝编织而成的中空结构;或者,所述的第一封堵盘包括至少两个固定臂,所述的固定臂为由镍钛合金管切割而成的直管或弧形弯管;或者,所述的第一封堵盘包括螺旋线骨架。Preferably, the second occlusion disk includes a hollow structure braided by nickel-titanium alloy wires; or, the first occlusion disk includes at least two fixing arms, and the fixing arms are made of nickel-titanium alloy A straight pipe or an arc-shaped bent pipe cut from a pipe; or, the first sealing disk includes a helical skeleton.
更优选地,所述的镍钛合金丝编织盘的内部或外部缝合固定至少一层高分子阻流膜,所述的固定臂的表面缝合固定高分子阻流膜,所述的螺旋线骨架的表面缝合固定高分子阻流膜。More preferably, the inside or outside of the nickel-titanium alloy wire braided disc is sutured to fix at least one layer of high polymer flow blocking film, the surface of the fixed arm is sutured to fix the high polymer flow blocking film, and the helical wire skeleton The surface is sutured to fix the polymer flow blocking membrane.
更优选地,所述的固定臂远离连接腰部的一端为球状结构。More preferably, the end of the fixed arm away from the waist is in a spherical structure.
优选地,所述的第一封堵盘和连接腰部通过第一固定件固定连接,所述的第二封堵盘和连接腰部通过第二固定件固定连接。Preferably, the first occlusion disk and the connecting waist are fixedly connected by a first fixing member, and the second occlusion disk and the connecting waist are fixedly connected by a second fixing member.
优选地,所述的第一封堵盘或第二封堵盘的外侧设有用于与封堵器的输送装置连接的螺纹钢套。Preferably, the outer side of the first occlusion disk or the second occlusion disk is provided with a threaded steel sleeve for connecting with the delivery device of the occluder.
优选地,所述的第一封堵盘或第二封堵盘的中部凹陷,所述的螺纹钢套设于第一封堵盘或第二封堵盘的外侧,第一封堵盘或第二封堵盘的和螺纹钢套的端面位于同一平面上。Preferably, the middle part of the first blocking disk or the second blocking disk is recessed, the threaded steel is sheathed on the outside of the first blocking disk or the second blocking disk, the first blocking disk or the second blocking disk The end faces of the two sealing discs and the threaded steel sleeve are located on the same plane.
优选地,所述的第一封堵盘或第二封堵盘的横截面为圆形,纵截面为方形、梯形或椭圆形。Preferably, the cross-section of the first blocking disk or the second blocking disk is circular, and the longitudinal section is square, trapezoidal or elliptical.
与现有技术相比,本发明的有益效果是:Compared with prior art, the beneficial effect of the present invention is:
1、本发明的自适应封堵器的连接腰部可拉伸和偏转,通过连接腰部的拉伸和偏转,可以起到调节封堵器的长度和偏转角度的作用,一般主动脉和肺动脉均存在一定夹角,在可调腰部的作用下,两侧的封堵盘可分别与主动脉和动脉导管壁面良好贴合。显著提高了封堵器的回弹性、固定性、封堵效果等主要性能;1. The connecting waist of the self-adaptive occluder of the present invention can be stretched and deflected. By stretching and deflecting the connecting waist, the length and deflection angle of the occluder can be adjusted. Generally, both the aorta and pulmonary artery exist With a certain included angle, under the action of the adjustable waist, the occlusion discs on both sides can fit well with the walls of the aorta and arterial duct respectively. Significantly improved the main properties of the occluder such as resilience, fixity, and occlusion effect;
2、本发明的封堵盘可采用螺旋线骨架,这种设计的好处是用单根丝材,通过鞘管能力相比传统封堵器有质的提升。同时,这种螺旋线骨架可以分别应用在封堵器上、下盘面,配合传统编织构成另外一个盘面;或螺旋线骨架同时应用在封堵器两个盘面。这样,根据不同人体结构所要求的回弹性、固定性和阻流性而选择不用的设计。如某盘片对回弹性和固定性要求较高,可采用螺旋线骨架;如对阻流性要求较高,可采用镍钛合金丝编织盘。2. The occlusion disk of the present invention can use a helical wire skeleton. The advantage of this design is that the ability to pass through the sheath tube with a single wire material is qualitatively improved compared with traditional occluders. At the same time, this helical wire skeleton can be applied to the upper and lower disks of the occluder respectively, and another disk is formed with traditional braiding; or the helical wire skeleton can be applied to both disks of the occluder at the same time. In this way, different designs are selected according to the resilience, fixity and flow resistance required by different human body structures. If a disc has high requirements on resilience and fixity, a helical wire skeleton can be used; if it has high requirements on flow resistance, a nickel-titanium alloy wire braided disc can be used.
3、本发明的自适应封堵器的在植入后几个月内,将有内皮细胞爬覆生长在镍钛合金丝编织盘的表面或固定臂的表面,使其表面内皮化,从而形成一层自体生物膜,最终治愈缺损。3. Within a few months after the implantation of the self-adaptive occluder of the present invention, endothelial cells will grow on the surface of the nickel-titanium alloy wire braided disc or the surface of the fixed arm to endothelialize the surface, thereby forming An autologous biofilm that eventually heals the defect.
附图说明Description of drawings
图1为实施例1中的自适应封堵器结构示意图;Fig. 1 is the structural representation of adaptive occluder in embodiment 1;
图2为实施例6中的自适应封堵器结构示意图;Fig. 2 is a schematic structural diagram of an adaptive occluder in embodiment 6;
图3为实施例7中的自适应封堵器结构示意图;Fig. 3 is a schematic structural diagram of an adaptive occluder in embodiment 7;
图4为四个和八个固定臂的分布状态图;Fig. 4 is the distribution diagram of four and eight fixed arms;
图5为实施例8中的自适应封堵器结构示意图;Fig. 5 is a schematic structural diagram of an adaptive occluder in embodiment 8;
图6为实施例9中的自适应封堵器结构示意图Fig. 6 is a schematic structural diagram of the self-adaptive occluder in embodiment 9
图7为实施例1中的自适应封堵器使用示意图;7 is a schematic diagram of the use of the self-adaptive occluder in Embodiment 1;
图8为实施例6中的自适应封堵器使用示意图;Figure 8 is a schematic diagram of the use of the self-adaptive occluder in embodiment 6;
图9为实施例7中的自适应封堵器使用示意图;Fig. 9 is a schematic diagram of the use of the self-adaptive occluder in embodiment 7;
图10为实施例9中的自适应封堵器使用示意图;Figure 10 is a schematic diagram of the use of the adaptive occluder in Embodiment 9;
图11为实施例2中的自适应封堵器结构示意图;Fig. 11 is a schematic structural diagram of the self-adaptive occluder in embodiment 2;
图12为实施例3中的自适应封堵器结构示意图;Fig. 12 is a schematic structural diagram of the self-adaptive occluder in embodiment 3;
图13为实施例4中的自适应封堵器结构示意图;Fig. 13 is a schematic structural diagram of an adaptive occluder in embodiment 4;
图14为实施例5中的自适应封堵器结构示意图;Fig. 14 is a schematic structural diagram of the self-adaptive occluder in embodiment 5;
图15为实施例10中的自适应封堵器结构示意图。Fig. 15 is a schematic structural diagram of the self-adaptive occluder in Embodiment 10.
具体实施方式Detailed ways
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。Below in conjunction with specific embodiment, further illustrate the present invention. It should be understood that these examples are only for illustrating the invention and are not intended to limit the scope of the invention. In addition, it should be understood that after reading the teachings of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of the present application.
实施例1Example 1
如图1所示,本实施例中的自适应封堵器包括用于封堵缺损处血流的第一封堵盘和第二封堵盘,所述的第一封堵盘连接可拉伸和偏转的连接腰部的一端,可拉伸和偏转的连接腰部的另一端连接第二封堵盘。As shown in Figure 1, the self-adaptive occluder in this embodiment includes a first occlusion disk and a second occlusion disk for occluding the blood flow at the defect, and the first occlusion disk is connected to stretchable One end connected to the waist is deflected, and the other end of the stretchable and deflectable waist is connected to the second occlusion disk.
所述的第一封堵盘为镍钛合金丝编织盘1,所述的镍钛合金丝编织盘1包括镍钛合金丝编织而成的中空双层结构,所述的中空双层结构的内部缝合固定一层高分子阻流膜8,起到封堵缺损处血流的作用。所述的镍钛合金丝编织盘的横截面为圆形,纵截面为椭圆形。The first plugging disc is a nickel-titanium alloy wire braided disc 1, and the nickel-titanium alloy wire braided disc 1 includes a hollow double-layer structure braided by nickel-titanium alloy wire, and the interior of the hollow double-layer structure is One layer of high molecular flow blocking membrane 8 is sutured and fixed to block the blood flow at the defect. The cross section of the nickel-titanium alloy wire braided disk is circular, and the longitudinal section is elliptical.
所述的第二封堵盘包括固定臂2,所述的固定臂2由镍钛合金管激光切割而成,共有16个,中心对称分布,固定臂2为弧形弯管,固定臂2的一端与连接腰部连接。所述的固定臂2的表面缝合固定高分子阻流膜,在植入后几个月内,其表面也可能内皮化,同时起到固定和封堵的作用。The second blocking disc includes a fixed arm 2. The fixed arm 2 is laser-cut from a nickel-titanium alloy tube, and there are 16 pieces in total, which are symmetrically distributed in the center. Attach at one end to the connecting waist. The surface of the fixation arm 2 is sutured to fix the polymer blocking membrane, and within a few months after implantation, its surface may also be endothelialized, and at the same time play the role of fixation and closure.
所述的连接腰部由镍钛合金丝编织而成。所述的连接腰部包括由镍钛合金丝编织而成的柱状本体3,所述的柱状本体3的侧壁形成有2个凸出的环形部分9。所述的凸出的环形部分9可使得连接腰部在拉伸和偏转时具有较大的余量,从而显著地改善其拉伸和偏转性能。The connecting waist is braided by nickel-titanium alloy wires. The connecting waist includes a columnar body 3 braided by nickel-titanium alloy wires, and two protruding annular parts 9 are formed on the side wall of the columnar body 3 . The protruding annular portion 9 can make the connecting waist have a larger margin when stretching and deflecting, thereby significantly improving its stretching and deflecting performance.
所述的固定臂2和连接腰部通过第一固定件5固定连接,所述的第一固定件5可由不锈钢等材料制成,为环形多层嵌套结构,用以连接直径不同的固定臂2和连接腰部。The fixed arm 2 and the connecting waist are fixedly connected by the first fixing member 5. The first fixing member 5 can be made of stainless steel and other materials, and is a ring-shaped multi-layer nesting structure, which is used to connect the fixing arms 2 with different diameters. and connect the waist.
所述的镍钛合金丝编织盘1和连接腰部通过第二固定件6固定连接。所述的第二固定件6可由不锈钢等材料制成,为环形多层嵌套结构,用以连接直径不同的镍钛合金丝编织盘1和连接腰部。The nickel-titanium alloy wire weaving disc 1 is fixedly connected with the connecting waist through the second fixing member 6 . The second fixing member 6 can be made of stainless steel and other materials, and is an annular multi-layer nested structure, used to connect the braided nickel-titanium alloy wire discs 1 with different diameters and the waist.
所述的镍钛合金丝编织盘1的外侧设有用于与封堵器的输送装置连接的螺纹钢套7。所述的螺纹钢套7可由不锈钢等材料制成,有内螺纹,与封堵器的输送装置(推送杆)前端外螺纹配合,在体外转动输送系统末端,即完成封堵器的释放。起到连接输送系统,输送封堵器,体内释放的作用。The outer side of the nickel-titanium alloy wire braided disc 1 is provided with a threaded steel sleeve 7 for connecting with the delivery device of the occluder. The threaded steel sleeve 7 can be made of stainless steel and other materials, has internal threads, cooperates with the external threads at the front end of the delivery device (push rod) of the occluder, and rotates the end of the delivery system outside the body to complete the release of the occluder. Play the role of connecting the delivery system, delivering the occluder, and releasing it in the body.
使用时,如图7所示,将螺纹钢套7与封堵器的输送装置15连接,将本实施例中的自适应封堵器输送至预定位置,从输送鞘管中释放出后,封堵器从细长条状恢复为双盘结构,固定于缺损残壁13的两侧,体外扭动封堵器的输送装置15,头部的螺纹旋松脱离,便可释放封堵器。在植入后几个月内,将有内皮细胞爬覆在镍钛合金丝编织盘1表面生长,使其表面内皮化,从而形成一层自体生物膜,最终治愈缺损。When in use, as shown in Figure 7, connect the threaded steel sleeve 7 to the delivery device 15 of the occluder, deliver the self-adaptive occluder in this embodiment to a predetermined position, release it from the delivery sheath, and seal it The occluder recovers from a slender strip to a double-disk structure, and is fixed on both sides of the defective residual wall 13. The delivery device 15 of the occluder is twisted outside the body, and the screw thread on the head is loosened to release the occluder. Within a few months after implantation, endothelial cells will grow on the surface of the braided nickel-titanium alloy wire disc 1 to endothelialize the surface, thereby forming a layer of autologous biofilm, and eventually heal the defect.
实施例2Example 2
如图1所示,本实施例中的自适应封堵器包括用于封堵缺损处血流的第一封堵盘和第二封堵盘,所述的第一封堵盘连接可拉伸和偏转的连接腰部的一端,可拉伸和偏转的连接腰部的另一端连接第二封堵盘。As shown in Figure 1, the self-adaptive occluder in this embodiment includes a first occlusion disk and a second occlusion disk for occluding the blood flow at the defect, and the first occlusion disk is connected to stretchable One end connected to the waist is deflected, and the other end of the stretchable and deflectable waist is connected to the second occlusion disk.
所述的第一封堵盘包括固定臂2,所述的固定臂2由镍钛合金管激光切割而成,共有8个,中心对称分布,固定臂2为直管,固定臂2的一端与连接腰部连接。所述的固定臂2的表面缝合固定高分子阻流膜8,在植入后几个月内,其表面也可能内皮化,同时起到固定和封堵的作用。The first blocking disk includes a fixed arm 2, the fixed arm 2 is laser cut from a nickel-titanium alloy tube, there are 8 pieces in total, and the center is symmetrically distributed. The fixed arm 2 is a straight tube, and one end of the fixed arm 2 is connected to the Link waist link. The surface of the fixed arm 2 is sutured to fix the polymer blocking membrane 8 , and within a few months after implantation, its surface may also be endothelialized, and at the same time play the role of fixation and closure.
所述的第一封堵盘为镍钛合金丝编织盘1,所述的镍钛合金丝编织盘1包括镍钛合金丝编织而成的中空双层结构,所述的中空双层结构的内部缝合固定一层高分子阻流膜,起到封堵缺损处血流的作用。所述的镍钛合金丝编织盘的横截面为圆形,纵截面为椭圆形。The first plugging disc is a nickel-titanium alloy wire braided disc 1, and the nickel-titanium alloy wire braided disc 1 includes a hollow double-layer structure braided by nickel-titanium alloy wire, and the interior of the hollow double-layer structure is A layer of polymer flow blocking membrane is sutured and fixed to block the blood flow at the defect. The cross section of the nickel-titanium alloy wire braided disk is circular, and the longitudinal section is elliptical.
所述的连接腰部包括由镍钛合金丝编织而成的单层的球面编织网18,所述的球面编织网18的一端连接第一封堵盘,另一端连接第二封堵盘。由于其具有较好的旋转和伸展特性,可以使封堵器的上下盘面呈角度释放,满足真实的不同解剖形状。The connecting waist includes a single-layer spherical braided mesh 18 braided by nickel-titanium alloy wires. One end of the spherical braided mesh 18 is connected to the first occlusion disk, and the other end is connected to the second occlusion disk. Due to its good rotation and extension characteristics, the upper and lower disks of the occluder can be released at an angle, satisfying different real anatomical shapes.
所述的固定臂2和连接腰部通过第一固定件5固定连接,所述的第一固定件5可由不锈钢等材料制成,为环形多层嵌套结构,用以连接直径不同的固定臂2和连接腰部。The fixed arm 2 and the connecting waist are fixedly connected by the first fixing member 5. The first fixing member 5 can be made of stainless steel and other materials, and is a ring-shaped multi-layer nesting structure, which is used to connect the fixing arms 2 with different diameters. and connect the waist.
所述的镍钛合金丝编织盘1和连接腰部通过第二固定件6固定连接。所述的第二固定件6可由不锈钢等材料制成,为环形多层嵌套结构,用以连接直径不同的镍钛合金丝编织盘1和连接腰部。The nickel-titanium alloy wire weaving disc 1 is fixedly connected with the connecting waist through the second fixing member 6 . The second fixing member 6 can be made of stainless steel and other materials, and is an annular multi-layer nested structure, used to connect the braided nickel-titanium alloy wire discs 1 with different diameters and the waist.
所述的镍钛合金丝编织盘1的外侧设有用于与封堵器的输送装置连接的螺纹钢套7。所述的螺纹钢套7可由不锈钢等材料制成,有内螺纹,与封堵器的输送装置(推送杆)前端外螺纹配合,在体外转动输送系统末端,即完成封堵器的释放。起到连接输送系统,输送封堵器,体内释放的作用。The outer side of the nickel-titanium alloy wire braided disc 1 is provided with a threaded steel sleeve 7 for connecting with the delivery device of the occluder. The threaded steel sleeve 7 can be made of stainless steel and other materials, has internal threads, cooperates with the external threads at the front end of the delivery device (push rod) of the occluder, and rotates the end of the delivery system outside the body to complete the release of the occluder. Play the role of connecting the delivery system, delivering the occluder, and releasing it in the body.
本实施例的自适应封堵器的使用方法与实施例1相同。The usage method of the self-adaptive occluder in this embodiment is the same as that in Embodiment 1.
实施例3Example 3
本实施例的自适应封堵器的结构类似于实施例2,区别在于,如图12所示,所述的可拉伸和偏转的连接腰部的结构不同,本实施例中,所述的可拉伸和偏转的连接腰部由套环19构成,所述的套环19的一端连接第一封堵盘,另一端连接第二封堵盘。The structure of the self-adaptive occluder of this embodiment is similar to that of Embodiment 2, the difference is that, as shown in Figure 12, the structure of the stretchable and deflectable connecting waist is different. The connecting waist for stretching and deflection is formed by a collar 19, one end of which is connected to the first occlusion disk, and the other end is connected to the second occlusion disk.
本实施例的自适应封堵器的使用方法与实施例1相同。The usage method of the self-adaptive occluder in this embodiment is the same as that in Embodiment 1.
实施例4Example 4
本实施例的自适应封堵器的结构类似于实施例2,区别在于,如图13所示,所述的可拉伸和偏转的连接腰部的结构不同,本实施例中,所述的可拉伸和偏转的连接腰部由弹簧20构成,所述的弹簧20的一端连接第一封堵盘,另一端连接第二封堵盘。The structure of the self-adaptive occluder of this embodiment is similar to that of Embodiment 2, the difference is that, as shown in Figure 13, the structure of the stretchable and deflectable connecting waist is different. The stretched and deflected connecting waist is formed by a spring 20, one end of which is connected to the first occlusion disk, and the other end is connected to the second occlusion disk.
本实施例的自适应封堵器的使用方法与实施例1相同。The usage method of the self-adaptive occluder in this embodiment is the same as that in Embodiment 1.
实施例5Example 5
本实施例的自适应封堵器的结构类似于实施例2,区别在于,(1)、如图14所示,所述的可拉伸和偏转的连接腰部的结构不同,本实施例中,所述的可拉伸和偏转的连接腰部由滑杆滑块组合构成,所述的滑杆滑块组合的一端连接第一封堵盘,另一端连接第二封堵盘。(2)所述的第一封堵盘和第二封堵盘包括固定臂2,所述的固定臂2由镍钛合金管激光切割而成,共有8个,中心对称分布,固定臂2为直管,固定臂2的一端与连接腰部连接。所述的固定臂2的表面缝合固定高分子阻流膜。The structure of the self-adaptive occluder of this embodiment is similar to that of Embodiment 2, the difference is that (1), as shown in Figure 14, the structure of the stretchable and deflectable connecting waist is different, in this embodiment, The stretchable and deflectable connecting waist is composed of a slider-bar combination, one end of the slider-bar combination is connected to the first blocking disk, and the other end is connected to the second blocking disk. (2) The first blocking disk and the second blocking disk include a fixed arm 2, and the fixed arm 2 is formed by laser cutting of a nickel-titanium alloy tube, and there are 8 pieces in total, symmetrically distributed in the center, and the fixed arm 2 is Straight pipe, one end of fixed arm 2 is connected with connecting waist. The surface of the fixed arm 2 is sutured to fix the polymer flow blocking film.
所述的滑杆滑块组合包括中心滑轨210、上滑块211、下滑块212、上滑杆213和下滑杆214,上滑块211和下滑块212分别设于中心滑轨210的上下两端并可独立地沿中心滑轨210滑动,上滑杆213穿过上滑块211,上滑块211可沿上滑杆213滑动,下滑杆214穿过下滑块212,下滑块212可沿下滑杆214滑动,上滑杆213和下滑杆214分别设于上支架215和下支架216上,上支架215和下支架216分别连接上封堵盘和下封堵盘。Described slide bar slide block combination comprises central slide rail 210, upper slide block 211, lower slide bar 212, upper slide bar 213 and lower slide bar 214, and upper slide block 211 and lower slide block 212 are respectively arranged on the center slide rail 210. The upper and lower ends can slide independently along the center slide rail 210, the upper slider 213 passes through the upper slider 211, the upper slider 211 can slide along the upper slider 213, the lower slider 214 passes through the lower slider 212, and the lower slider 212 can slide along the lower rod 214, the upper sliding rod 213 and the lower rod 214 are respectively arranged on the upper bracket 215 and the lower bracket 216, and the upper bracket 215 and the lower bracket 216 are respectively connected to the upper sealing plate and the lower sealing plate.
本实施例的自适应封堵器的使用方法与实施例1相同。The usage method of the self-adaptive occluder in this embodiment is the same as that in Embodiment 1.
实施例6Example 6
如图2所示,本实施例中的自适应封堵器的结构类似于实施例1,区别在于,所述的镍钛合金丝编织盘1的纵截面为梯形,其中部凹陷,所述的镍钛合金丝编织盘1和螺纹钢套7的端面位于同一平面上,使细胞易于爬覆,加速内皮化和恢复。其使用状态如图8所示。As shown in Figure 2, the structure of the self-adaptive occluder in this embodiment is similar to that of Embodiment 1, the difference is that the longitudinal section of the nickel-titanium alloy wire braided disc 1 is trapezoidal, with a concave middle, and the The end faces of the nickel-titanium alloy wire braided disc 1 and the threaded steel sleeve 7 are located on the same plane, which makes it easy for cells to climb and cover, and accelerates endothelialization and recovery. Its use status is shown in Figure 8.
实施例7Example 7
如图3所示,本实施例中的自适应封堵器的结构类似于实施例2,区别在于,所述的固定臂2为直管,其个数为4个或8个,均匀分布在同一平面上,如图4所示。而且,所述的固定臂2远离连接腰部3的一端为球状结构10。As shown in Figure 3, the structure of the self-adaptive occluder in this embodiment is similar to Embodiment 2, the difference is that the fixed arm 2 is a straight tube, the number of which is 4 or 8, evenly distributed in the on the same plane, as shown in Figure 4. Moreover, the end of the fixed arm 2 away from the waist 3 is a spherical structure 10 .
本实施例中,固定臂2的结构更加扁平,以避免影响或磨损其他的心内组织和结构,且能减少占用心腔的容积。所述的固定臂2远离连接腰部3的一端为球状结构,可避免戳伤心内组织。In this embodiment, the structure of the fixed arm 2 is flatter to avoid affecting or wearing other cardiac tissues and structures, and can reduce the occupied volume of the cardiac cavity. The end of the fixed arm 2 away from the connection with the waist 3 has a spherical structure, which can avoid poking the heart tissue.
固定臂2的外侧缝合高分子阻流膜8后,可增强植入后的即时封堵效果,再加上固定臂2的扁平设计,使细胞易于爬覆,加速内皮化和恢复。After the outer side of the fixed arm 2 is sutured with a polymer barrier membrane 8, the immediate sealing effect after implantation can be enhanced. In addition, the flat design of the fixed arm 2 makes it easy for cells to climb and cover, and accelerates endothelialization and recovery.
本实施例中的自适应封堵器的使用状态如图9所示。The usage status of the self-adaptive occluder in this embodiment is shown in FIG. 9 .
实施例8Example 8
如图5所示,本实施例中的自适应封堵器的结构类似于实施例3,其区别在于,所述的螺纹钢套7设于固定臂2的外侧。根据心脏缺损的不同情况,如两侧的压力差不同(一般左房血压大于右房,左室血压大于右室),以及缺损两侧的结构影响不同,镍钛合金丝编织盘1和固定臂2可互换位置,螺纹钢套7置于固定臂2侧,以达到最好的封堵效果和固定效果。As shown in FIG. 5 , the structure of the self-adaptive occluder in this embodiment is similar to that of Embodiment 3, the difference being that the threaded steel sleeve 7 is arranged on the outside of the fixed arm 2 . According to the different conditions of the heart defect, such as the difference in pressure difference between the two sides (generally, the blood pressure of the left atrium is greater than that of the right atrium, and the blood pressure of the left ventricle is greater than that of the right ventricle), and the influence of the structure on both sides of the defect is different, the Nitinol alloy wire braided disc 1 and the fixed arm 2 Interchangeable positions, the threaded steel sleeve 7 is placed on the side of the fixed arm 2 to achieve the best blocking effect and fixing effect.
实施例9Example 9
如图6所示,本实施例中的自适应封堵器的结构类似于实施例3,其区别在于,所述的镍钛合金丝编织盘1的纵截面为方形,形成圆柱形结构。针对动脉导管未闭(PDA)封堵器,镍钛合金丝编织盘根据连接主动脉和肺动脉的通道形状可为圆柱形或类圆锥状。其使用状态如图10所示,固定臂2放置于主动脉侧固定。镍钛合金丝编织盘1起到封堵作用。而一般主动脉16和肺动脉17均存在一定夹角,在连接腰部3的作用下,固定臂2和镍钛合金丝编织盘1可分别与主动脉和动脉导管壁面良好贴合。As shown in FIG. 6 , the structure of the self-adaptive occluder in this embodiment is similar to that of Embodiment 3, the difference being that the longitudinal section of the nickel-titanium alloy wire braided disc 1 is square, forming a cylindrical structure. For the patent ductus arteriosus (PDA) occluder, the nitinol wire braided disc can be cylindrical or conical according to the shape of the channel connecting the aorta and pulmonary artery. Its use state is shown in FIG. 10 , and the fixed arm 2 is placed on the side of the aorta for fixation. The nickel-titanium alloy wire braided disc 1 plays a sealing role. Generally, the aorta 16 and the pulmonary artery 17 have a certain angle, and under the action of the connecting waist 3, the fixed arm 2 and the nitinol wire braided disc 1 can fit well with the walls of the aorta and arterial duct respectively.
实施例10Example 10
本实施例的自适应封堵器的结构类似于实施例2,区别在于,如图15所示,所述的第一封堵盘和第二封堵盘的结构不同,本实施例中,所述的第一封堵盘和第二封堵盘包括螺旋线骨架22,所述的螺旋线骨架的表面缝合有固定高分子阻流膜。The structure of the self-adaptive occluder of this embodiment is similar to that of Embodiment 2, the difference is that, as shown in Figure 15, the structure of the first occlusion disk and the second occlusion disk are different, in this embodiment, the The above-mentioned first occluding disk and the second occluding disk include a helical wire skeleton 22, and the surface of the helical wire skeleton is sewed with a fixed polymer flow-blocking membrane.
本实施例的自适应封堵器的使用方法与实施例1相同。The usage method of the self-adaptive occluder in this embodiment is the same as that in Embodiment 1.
Claims (10)
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| CN106466196A (en) * | 2016-09-22 | 2017-03-01 | 杭州诺茂医疗科技有限公司 | A kind of split type occluder for left auricle |
| CN106510788A (en) * | 2016-12-12 | 2017-03-22 | 上海心玮医疗科技有限公司 | Left atrial appendage occlusion device |
| CN108938039A (en) * | 2018-08-14 | 2018-12-07 | 上海微密医疗科技有限公司 | Novel encephalic aneurysm plugging device and preparation method thereof |
| CN109862832A (en) * | 2016-08-12 | 2019-06-07 | 伊森舍医疗公司 | Vascular occlusion device with locking assembly for obturator |
| EP3398523A4 (en) * | 2015-12-29 | 2019-12-11 | Shenzhen KYD Biomedical Technology Co. Ltd | DEVICE FOR CLOSING THE ATRIUM OF THE LEFT ATRIUM |
| CN111000601A (en) * | 2019-12-17 | 2020-04-14 | 先健科技(深圳)有限公司 | Occluder and occlusion system |
| CN111000600A (en) * | 2019-12-17 | 2020-04-14 | 先健科技(深圳)有限公司 | Occluders and Occlusion Systems |
| CN112472197A (en) * | 2020-12-30 | 2021-03-12 | 东南大学泰州生物医药与医疗器械研究院 | Left auricle plugging device |
| CN113384308A (en) * | 2021-06-02 | 2021-09-14 | 上海捍宇医疗科技股份有限公司 | Hook connection type pierceable plugging device system for conveying room wall through catheter |
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| CN113520486A (en) * | 2021-06-24 | 2021-10-22 | 珠海市人民医院 | Adjustable plugging device |
| US11291454B2 (en) | 2015-12-29 | 2022-04-05 | Shenzhen Kyd Biomedical Technology Co. Ltd. | Left atrial appendage closure apparatus |
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| CN115956962A (en) * | 2023-03-02 | 2023-04-14 | 徐州亚太科技有限公司 | A patent foramen ovale occluder |
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| CN112472197A (en) * | 2020-12-30 | 2021-03-12 | 东南大学泰州生物医药与医疗器械研究院 | Left auricle plugging device |
| CN113384308A (en) * | 2021-06-02 | 2021-09-14 | 上海捍宇医疗科技股份有限公司 | Hook connection type pierceable plugging device system for conveying room wall through catheter |
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