CN114788712A - Ey室间隔缺损封堵器 - Google Patents
Ey室间隔缺损封堵器 Download PDFInfo
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- CN114788712A CN114788712A CN202110106327.7A CN202110106327A CN114788712A CN 114788712 A CN114788712 A CN 114788712A CN 202110106327 A CN202110106327 A CN 202110106327A CN 114788712 A CN114788712 A CN 114788712A
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- occluder
- septal defect
- ventricular septal
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- 208000001910 Ventricular Heart Septal Defects Diseases 0.000 title claims abstract description 31
- 201000003130 ventricular septal defect Diseases 0.000 title claims abstract description 30
- 238000004873 anchoring Methods 0.000 claims abstract description 17
- 229910000831 Steel Inorganic materials 0.000 claims description 17
- 239000010959 steel Substances 0.000 claims description 17
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 15
- 210000005240 left ventricle Anatomy 0.000 claims description 11
- 229910052751 metal Inorganic materials 0.000 claims description 11
- 239000002184 metal Substances 0.000 claims description 11
- 230000002861 ventricular Effects 0.000 claims description 7
- 210000005241 right ventricle Anatomy 0.000 claims description 5
- 238000005452 bending Methods 0.000 claims description 2
- 239000010935 stainless steel Substances 0.000 claims description 2
- 229910001220 stainless steel Inorganic materials 0.000 claims description 2
- RVTZCBVAJQQJTK-UHFFFAOYSA-N oxygen(2-);zirconium(4+) Chemical compound [O-2].[O-2].[Zr+4] RVTZCBVAJQQJTK-UHFFFAOYSA-N 0.000 claims 2
- 238000003754 machining Methods 0.000 claims 1
- 210000004165 myocardium Anatomy 0.000 abstract description 4
- 239000012528 membrane Substances 0.000 abstract description 3
- 230000000149 penetrating effect Effects 0.000 abstract description 2
- 238000002560 therapeutic procedure Methods 0.000 abstract description 2
- 239000007943 implant Substances 0.000 abstract 2
- 210000005242 cardiac chamber Anatomy 0.000 abstract 1
- 208000032170 Congenital Abnormalities Diseases 0.000 description 2
- 208000002330 Congenital Heart Defects Diseases 0.000 description 2
- 230000000903 blocking effect Effects 0.000 description 2
- 230000000747 cardiac effect Effects 0.000 description 2
- 208000028831 congenital heart disease Diseases 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000009941 weaving Methods 0.000 description 2
- 208000007536 Thrombosis Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 210000003698 chordae tendineae Anatomy 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 210000000596 ventricular septum Anatomy 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- 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
- A61B2017/00579—Barbed implements
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Abstract
本发明涉及EY室间隔缺损封堵器，通过铆钉结构刺入心肌以锚定该装置；因不含盘状结构，植入后完全不凸入心室腔，可降低对心脏结构功能的影响；该封堵器的形状专为非膜部室间隔缺损封堵治疗设计，为介入治疗该类型室间隔缺损提供器材保障。
Description
技术领域
本发明涉及一种医疗器械的封堵器，特别是EY室间隔缺损封堵器。
背景技术
室间隔缺损为最常见的先天性心脏病畸形，可单独存在，亦可与其他畸形合并发生。本病的发生率约占存活新生儿的0.2%，在先天性心脏病中占比超过20%。这种缺损可出现在室间隔的任何部位。微创是治疗的首选方案。室间隔缺损封堵器即是这种微创治疗室间隔缺损必不可少的医疗器械。目前临床应用的封堵器多含有盘状结构，该结构会凸入心室腔，影响心脏结构功能，使室间隔缺损微创治疗适用范围受到限制，例如瓣膜附近、腱索附近、传导束附近及流出道部位室间隔缺损，因存在封堵器盘状结构影响心脏重要结构的风险，而不得不选择开放手术方案。
发明内容
鉴于以上所述现有技术的缺点，本发明要解决的技术问题在于提供一种不含盘状结构的室间隔缺损封堵器，通过铆钉结构刺入心肌而锚定在室间隔缺损部位，达到封堵室间隔缺损的效果。
本发明是这样实现的：EY室间隔缺损封堵器，包括封堵器主体、钢套以及铆钉结构，所述封堵器主体为镍钛合金丝编织网结构。其特征在于，封堵器主体轮廓类似于瘦腰的圆柱体，由左心室面、锚定面和右心室面组成，所述左心室面的中心设有用于捆扎镍钛合金丝断端的钢套，钢套的外端设有内螺纹，后者与螺母具有相似的功能构造，用于与推送封堵器的钢缆进行螺旋连接；所述左心室面和右心室面的直径相等，且大于腰部的直径。
所述主体和铆钉之间为一体成型，其特征在于部分镍钛合金丝断端位于锚定面，其余于左心室面中心点被钢套捆扎。
所述弹性金属丝为镍钛合金金属丝。所述钢套由医用不锈钢317L经机械精密加工所得。
所述铆钉结构为金属丝断端在锚定面弯折形成，垂直于所处的锚定面。
本发明的有益效果是：EY室间隔缺损封堵器，由于不存在盘状结构，完全不凸出于心室腔，可降低对心室结构功能的影响；铆钉结构刺入心肌，锚定面弧度与室间隔缺损凸凹吻合，贴合性较好；封堵器主体为中空结构，早期只承受左心室部分压力，降低了脱落的风险；该封堵器的形状专为非膜部室间隔缺损封堵治疗设计，为介入治疗该类型室间隔缺损提供器材保障。
附图说明
图1为本申请中EY室间隔缺损封堵器的结构示意图。
图2为EY室间隔缺损封堵器释放后的封堵示意图。
图中：1 主体，2 铆钉，3 钢套，4 右心室面，5 左心室面，6 锚定面，7 腰部，8 镍钛合金丝。
具体实施方式
如附图1所示，EY室间隔缺损封堵器，外形类似导轮，所述封堵器由多根镍钛合金丝编织一体成型。该封堵器包含左心室面、右心室面、锚定面、钢套和铆钉结构。
所述主体和铆钉为一体成型，部分金属丝断端于锚定面弯折成铆钉结构，其余于左心室面被钢套捆扎固定。
所述镍钛合金丝为医用高弹性镍钛合金丝。
所述铆钉结构与其所处的锚定面垂直。
本发明的制作方法为：由多根高弹性镍钛合金丝通过编织机编制出一定直径和密度的中空球体，通过模具和热处理使球体定型。右心室面不存在金属丝断端，部分金属丝断端均匀分布于锚定面，并弯折垂直锚定面，形成铆钉结构。其余金属丝断端于左心室面被钢套通过挤压的方式捆扎固定。
本发明通过镍钛合金的高弹性和记忆性能，在外力作用下将该封堵器收拉鞘管内呈一线条状，经皮穿刺技术，将封堵器输送到室间隔的缺损部位，释放后封堵器完全打开，恢复自然状态，锚定面贴合室间隔缺损壁，铆钉结构刺入心肌。封堵器早期只承受左心室的部分压力，因此不易脱落，后期封堵器固定牢靠，主体内血栓形成，阻断异常血流，实现了封堵的目的，达到治疗效果。该堵器不适用于膜部室间隔缺损部位的封堵治疗。
Claims (7)
1.EY室间隔缺损封堵器，包括封堵器主体、钢套以及铆钉结构，所述封堵器主体为镍钛合金丝编织网结构。
2.其特征在于，封堵器主体轮廓类似于瘦腰的圆柱体，由左心室面、锚定面和右心室面组成；所述左心室面的中心设有用于捆扎镍钛合金丝断端的钢套，钢套的外端设有内螺纹，后者与螺母具有相似的功能构造，用于与推送封堵器的钢缆进行螺旋连接；所述左心室面和右心室面的直径相等，且大于腰部的直径。
3.根据权利要求1所述的EY室间隔缺损封堵器，其特征在于：所述主体和铆钉之间为一体成型件，由多根镍钛合金丝编织而成。
4.根据权利要求2或3所述的EY室间隔缺损封堵器，其特征在于部分镍钛合金丝断端位于锚定面，其余于左心室面中心点被钢套捆扎。
5.根据权利要求1或3所述的EY室间隔缺损封堵器，其特征在于：所述铆钉结构为金属丝断端在锚定面弯折形成，垂直于所处的锚定面。
6.根据权利要求1或3所述的EY室间隔缺损封堵器，其特征在于：所述弹性金属丝为镍钛合金金属丝。
7.所述钢套为医用不锈钢317L经机械精密加工所得。
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| CN202110106327.7A CN114788712A (zh) | 2021-01-26 | 2021-01-26 | Ey室间隔缺损封堵器 |
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| CN202110106327.7A CN114788712A (zh) | 2021-01-26 | 2021-01-26 | Ey室间隔缺损封堵器 |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050113868A1 (en) * | 2003-11-20 | 2005-05-26 | Devellian Carol A. | Device, with electrospun fabric, for a percutaneous transluminal procedure, and methods thereof |
| US20070225760A1 (en) * | 2006-03-24 | 2007-09-27 | Occlutech Gmbh | Occlusion Device and Method for its Manufacture |
| US20110054519A1 (en) * | 2008-03-26 | 2011-03-03 | Malte Neuss | Device for closing defects in the vascular system |
| CN110313946A (zh) * | 2018-03-28 | 2019-10-11 | 上海微创医疗器械（集团）有限公司 | 一种封堵装置及其制备方法 |
| US20200138569A1 (en) * | 2017-07-06 | 2020-05-07 | Raghuveer Basude | Tissue grasping devices and related methods |
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- 2021-01-26 CN CN202110106327.7A patent/CN114788712A/zh active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050113868A1 (en) * | 2003-11-20 | 2005-05-26 | Devellian Carol A. | Device, with electrospun fabric, for a percutaneous transluminal procedure, and methods thereof |
| US20070225760A1 (en) * | 2006-03-24 | 2007-09-27 | Occlutech Gmbh | Occlusion Device and Method for its Manufacture |
| US20110054519A1 (en) * | 2008-03-26 | 2011-03-03 | Malte Neuss | Device for closing defects in the vascular system |
| US20200138569A1 (en) * | 2017-07-06 | 2020-05-07 | Raghuveer Basude | Tissue grasping devices and related methods |
| CN110313946A (zh) * | 2018-03-28 | 2019-10-11 | 上海微创医疗器械（集团）有限公司 | 一种封堵装置及其制备方法 |
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