CN107320217B - 介入式瓣膜输送器 - Google Patents

介入式瓣膜输送器 Download PDF

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CN107320217B
CN107320217B CN201710486045.8A CN201710486045A CN107320217B CN 107320217 B CN107320217 B CN 107320217B CN 201710486045 A CN201710486045 A CN 201710486045A CN 107320217 B CN107320217 B CN 107320217B
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valve
insertion type
type valve
bracket
valve bracket
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CN107320217A (zh
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董念国
尚小珂
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Wuhan Wei Ke Medical Technology Co., Ltd.
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Wuhan Wei Ke Medical Technology Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

本发明提供了介入式瓣膜输送器，包括，瓣膜支架；所述瓣膜支架为网状支架，瓣膜支架的两端均开设位置相应的销孔，瓣膜支架两端向内扣合使所述瓣膜支架呈环形，销轴插入销孔内，将瓣膜支架的两端固定；相邻两个单元格通过连接片连接；所述连接片材质为记忆合金，所述连接片的记忆形状呈螺旋状。本发明提供的一种介入式瓣膜输送器，通过改进瓣膜支架结构，使得瓣膜支架可进行回收。

Description

介入式瓣膜输送器
技术领域
本发明涉及介入式医疗器械技术领域,尤其涉及介入式瓣膜输送器。
背景技术
长期以来，瓣膜置换只能用外科手术，需要建立体外循环行开胸以及心包切开术，将瓣膜缝到病变位置，手术风险很大而且对病人造成巨大生理和心理创伤，另外有很大比例的病人，尤其是70岁以上的患者属于外科禁忌患者，不能行外科手术，这个比例占到30％的患者。2002年，国外首次进行主动脉介入瓣膜的临床，可以不行开胸手术，直接将瓣膜通过导管释放到病变位置，病人没有任何大的痛苦，术后病人很快便可出院。而介入式瓣膜输送系统中，存在介入式瓣膜无法回收的技术难题，使得在扩张后的介入式瓣膜无法缩小而通过血管回收。
发明内容
针对现有技术的上述缺陷和问题，本发明实施例的目的是提供介入式瓣膜输送器。
为了达到上述目的，本发明提供如下技术方案：
介入式瓣膜输送器，包括，瓣膜支架；所述瓣膜支架为网状支架，瓣膜支架的两端均开设位置相应的销孔，瓣膜支架两端向内扣合使所述瓣膜支架呈环形，销轴插入销孔内，将瓣膜支架的两端固定；
相邻两个单元格通过连接片连接；所述连接片材质为记忆合金，所述连接片的记忆形状呈螺旋状。
其中，还包括，牛心包瓣膜，所述牛心包瓣膜缝合于所述瓣膜支架上，形成介入式瓣膜。
其中，所述销轴的近端开设连接孔。
其中，还包括，输送器；所述输送器包括外鞘管和推送管，推送管的远端设置气囊，所述介入式瓣膜收缩包覆依附于气囊外；所述推送管的远端设置于连接孔位置相应的凸起，所述凸起插入所述连接孔内。
其中，所述推送管的远端设置软尖头，所述软尖头表面设置环状凸起。
其中，还包括输气装置，所述输气装置与所述推送管连通。
本发明提供的一种介入式瓣膜输送器，通过改进瓣膜支架结构，使得瓣膜支架可进行回收。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动性的前提下，还可以根据这些附图获得其他的附图。
图1是本发明的瓣膜支架结构示意图；箭头方向为连接片欲弯曲方向；
图2是本发明介入式瓣膜俯视图；
图3是本发明介入式瓣膜输送器释放介入式瓣膜时的结构示意图；
图4是图3的A部位的放大结构示意图；
图5是本发明介入式瓣膜输送器未释放介入式瓣膜时的结构示意图；
图6是图5的B部位的放大结构示意图；
图7是连接片记忆形状结构示意图；
图8是抽出销轴时介入式瓣膜形状示意图。
具体实施方式
下面将结合本发明的实施例，对本发明的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
根据图1-8所示，作为实施例，介入式瓣膜输送器需通过导丝引导进入相应位置，导丝为本领域中成熟的现有技术，在此不做赘述。瓣膜支架1为网状支架，网状支架的单元格2呈菱形，使得当瓣膜支架1受外力扩张时，菱形的单元格变形，使得瓣膜支架1扩张至相应尺寸。网状支架的两端开设相应销孔，将瓣膜支架的两端向内扣合，使得网状支架形成一环形，将销轴3插入销孔内，将瓣膜支架1的两端固定，从而获得呈环形网状的瓣膜支架1。将牛心包瓣膜4通过医用缝合线缝合至瓣膜支架1的缝合孔101上，制成介入式瓣膜5。
如图2-6所示，将制成的介入式瓣膜5套装于推送管6的远端，销轴3的近端开设连接孔301，推送管6的远端设置于连接孔301相应的凸起601，使凸起插入连接孔内，使介入式瓣膜5固定于推送管6的远端。在推送管6的远端端部固定安装软尖头9，采用软尖头9是为了可以顺应导丝平滑地向前推进瓣膜输送系统，而不会对所经过的组织不造成损伤。外鞘管7套装于推送管6外，固定于股动脉穿刺孔处，起到固定及定位作用。推送管6可延外鞘管7进行前后移动。输气装置8用于为气囊10输气，使得气囊10膨胀。输气装置8可采用现有技术或设备实现上述功能。当推送管6将介入式瓣膜推送至相应位置，使用输气装置8向气囊10输气，气囊10膨胀向外推动介入式瓣膜5，使得瓣膜支架1变形，从而扩大直径，直至卡至相应位置处。输气装置停止输气，气囊10排气变小，凸起601脱离连接孔301，延导丝将推送管收回。
当回收时，延导丝将推送管6送至介入式瓣膜5处，将凸起601插入连接孔301内，回拉推送管6，将销轴3从销孔内抽出。相邻两个单元格2通过连接片11连接，连接片11的材质为记忆合金，连接片11的记忆形状呈螺旋状。螺旋的弯曲方向为图1中箭头方向，因此当取出销,3时，瓣膜支架在连接片恢复记忆形状的带动下弯曲收缩变小，从而包裹于软尖头9处，通过回拉推送管，即可将介入式瓣膜回收。
在一种可选的实施例中，如图3、5所示，软尖头9表面设置环状凸起12，防止收缩的瓣膜支架5从软尖头9上脱落。
以上所述，仅为本发明的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应所述以权利要求的保护范围为准。

Claims (6)

1.介入式瓣膜输送器，包括，瓣膜支架；其特征在于：所述瓣膜支架为网状支架，瓣膜支架的两端均开设位置相应的销孔，瓣膜支架两端向内扣合使所述瓣膜支架呈环形，销轴插入销孔内，将瓣膜支架的两端固定；
相邻两个单元格通过连接片连接；所述连接片材质为记忆合金，所述连接片的记忆形状呈螺旋状。
2.根据权利要求1所述的介入式瓣膜输送器，其特征在于：还包括，牛心包瓣膜，所述牛心包瓣膜缝合于所述瓣膜支架上，形成介入式瓣膜。
3.根据权利要求2所述的介入式瓣膜输送器，其特征在于：所述销轴的近端开设连接孔。
4.根据权利要求3所述的介入式瓣膜输送器，其特征在于：还包括，输送器；所述输送器包括外鞘管和推送管，推送管的远端设置气囊，所述介入式瓣膜收缩包覆依附于气囊外；所述推送管的远端设置与连接孔位置相应的凸起，所述凸起插入所述连接孔内。
5.根据权利要求4所述的介入式瓣膜输送器，其特征在于：所述推送管的远端设置软尖头，所述软尖头表面设置环状凸起。
6.根据权利要求5所述的介入式瓣膜输送器，其特征在于：还包括输气装置，所述输气装置与所述推送管连通。
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CN109259908A (zh) * 2018-09-26 2019-01-25 广州医科大学 一种新型载药气道支架及其制备方法
US11554034B2 (en) * 2020-10-06 2023-01-17 Venus Medtech (Hangzhou) Inc. Method and assembly for securing an implantable medical device on a delivery system

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