CN111938868A - 一种治疗动脉导管未闭重度肺动脉高压装置及其使用方法 - Google Patents
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Abstract
本发明涉及一种治疗动脉导管未闭重度肺动脉高压装置及其使用方法，包括瓣膜支架、输送系统；导管支架包括血管支架、两端固定支架、单向膜；血管支架为圆管状，侧壁是记忆金属编织的网格，内壁附有塑料膜；两端固定架焊接在血管支架两端；两端固定支架的尖端部分附有显影镀层；单向膜为漏斗状生物瓣膜，固定在血管支架内；输送系统包括鞘管、导管、推送杆；鞘管为塑料管，两端设有显影环；尾端连接有导管；导管为血管介入导管，头端连接鞘管；推送杆血管介入导丝，头端安装有推送块；推送块为圆柱塑料块。本发明使用输送系统将导管支架通过血管通路送至动脉导管处释放，导管支架展开固定在动脉导管中，内置单向膜阻止血液从主动脉流向肺动脉。
Description
技术领域
本发明涉及医疗器械领域，具体涉及一种治疗动脉导管未闭重度肺动脉高压装置及其使用方法。
背景技术
肺动脉高压指肺动脉压力升高超过一定界值的一种血流动力学和病理生理状态，可导致右心衰竭，可以是一种独立的疾病，也可以是并发症，还可以是综合征。其血流动力学诊断标准为：海平面静息状态下，右心导管检测肺动脉平均压≥25mmHg。肺动脉高压是一种常见病、多发病，且致残率和病死率均很高，应引起人们的高度重视。
动脉导管未闭也是导致肺动脉高压的原因，动脉导管原本系胎儿时期肺动脉与主动脉间的正常血流通道，由于此时肺呼吸功能障碍，来自右心室的肺动脉血经导管进入降主动脉，而左心室的血液则进入升主动脉，故动脉导管为胚胎时期特殊循环方式所必需。出生后，肺膨胀并承担气体交换功能，肺循环和体循环各司其职，不久导管因废用即自选闭合。如持续不闭合而形成动脉导管未闭。应施行手术，中断其血流。动脉导管未闭是一种较常见的先天性心血管畸形，占先天性心脏病总数的12％～15％,女性约两倍于男性。约10％的病例并存其他心血管畸形。动脉导管未闭的临床表现主要取决于主动脉至肺动脉分流血量的多少以及是否产生继发肺动脉高压和其程度。轻者可无明显症状，重者可发生心力衰竭。常见的症状有劳累后心悸、气急、乏力，易患呼吸道感染和生长发育迟缓。晚期肺动脉高压严重，产生逆向分流时可出现下半身发绀。动脉导管未闭体检时，典型的体征是胸骨左缘第2肋间听到响亮的连续性机器样杂音，伴有震颤。肺动脉瓣第2音亢进，但常被响亮的杂音所掩盖。分流量较大者，在心尖区尚可听到因二尖瓣相对性狭窄产生的舒张期杂音。测血压示收缩压多在正常范围，而舒张压降低，因而脉压增宽，四肢血管有水冲脉和枪击音。婴幼儿可仅听到收缩期杂音。晚期出现肺动脉高压时，杂音变异较大，可仅有收缩期杂音，或收缩期杂音亦消失而代之以肺动脉瓣关闭不全的舒张期杂音。
现今处理动脉导管未闭导致的肺动脉高压的方法为采取开胸手术，将动脉导管进行手术闭合，该方法需要进行麻醉开胸，手术时间长，危险性高，创口面积大，术后恢复时间长；同时先天性心脏病的患者若是完全阻断了动脉导管，肺动脉高压依然存在，高压问题也未能解决。
发明内容
为解决以上问题，本发明的方案为：提供一种治疗动脉导管未闭重度肺动脉高压装置及其使用方法。
一种治疗动脉导管未闭重度肺动脉高压装置，包括导管支架、输送系统；
所述导管支架包括血管支架、两端固定支架、单向膜；所述血管支架为圆管状，侧壁时记忆金属编织的网格，内壁附有塑料膜；所述两端固定架为倒V型的记忆金属连接成的环，焊接在血管支架两端；两端固定支架的尖端部分为圆角，圆角上附有显影镀层；所述单向膜为漏斗状软硅胶膜，前后开口，固定在血管支架内；
所述输送系统包括鞘管、导管、推送杆；所述鞘管为塑料管，两端设有显影环；尾端连接有导管；所述导管为血管介入导管，头端连接鞘管；所述推送杆血管介入导丝，头端安装有推送块；所述推送块为圆柱塑料块，内径小于鞘管0.5mm。
进一步的，所述记忆金属为镍钛记忆合金。
进一步的，所述网格的孔投影形状为菱形，网孔的变形法方向为菱形的孔横向延伸，竖向缩短。
进一步的，所述两端固定支架的变形方向为以血管支架底面为圆形向四周翘起。
进一步的，所述塑料膜为硅橡胶膜，显影镀层为黄金镀层。
进一步的，所述显影环为不锈钢环。
一种治疗动脉导管未闭重度肺动脉高压装置的使用方法，包括以下步骤：
(1)建立股静脉—下腔静脉—右心室—肺动脉通路；
(2)压缩血管支架的直径，将两端固定支架顺直，将导管支架放置入鞘管中：
(3)在X光下使用介入导丝引导鞘管进入股静脉，沿着通路直达肺动脉，观看鞘管两端显影环判断鞘管是否到右心室动脉导管内；
(4)退出导丝，推送杆送入鞘管未端的导管中，捏住推送杆，向后撤鞘管，推送块将导管支架留在右心室动脉导管内；
(5)导管支架的记忆金属恢复原状，血管支架直径向外膨胀，两端固定支架向四周翘起卡在右心室动脉导管两端；
(6)从通路中退出输送系统。
进一步的，所述单向膜的漏斗形状的窄端指向为从肺动脉指向右心室动脉。
发明的有益效果
(1)该装置的输送系统在建立股静脉—下腔静脉—右心室—肺动脉通路后，沿着通路将该装置送至动脉导管处，是一种微创为学管介入疗法，具有创口面积小，安全型高，手术后恢复快的优点；
(2)该装置的导管支架内设置了单向膜，该单向膜能阻止主动脉的血液向肺动脉流通，但肺动脉高压时能血液能从肺动脉经导管支架进入主动脉内，降低肺动脉内压力。
附图说明
为了更清晰地说明本发明实施例中的技术方案，下面将对实施例中所需要使用的附图简单地介绍，显而易见地，下面描述中的附图仅仅是本发明中记载的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其它的附图。
图1为治疗动脉导管未闭重度肺动脉高压及其输送系统的结构示意图：
图2为输送系统的结构示意图：
图3为导管支架收缩状态的结构示意图：
图4为导管支架收缩状态的剖面结构示意图：
图5为导管支架释放状态的结构示意图：
图6为导管支架释放状态的剖面结构示意图：
说明书附图中各部件及其标号如下：
导管支架1、血管支架1-1、两端固定支架1-2、单向膜1-3、塑料膜1-4、显影镀层1-5；
输送系统2、鞘管2-1、导管2-2、推送杆2-3、推送块2-4、显影环2-5。
具体实施方式
下面将通过具体实施例对本发明的技术方案进行清楚、完整地描述。
实施例Ⅰ
本发明的治疗动脉导管未闭重度肺动脉高压装置结构如图1～6所示：包括导管支架1、输送系统2；
所述导管支架1包括血管支架1-1、两端固定支架1-2、单向膜1-3；所述血管支架1-1为圆管状，侧壁记忆金属编织的网格，内壁附有塑料膜1-4，塑料膜1-4为硅橡胶膜，硅橡胶膜延展性好能跟随血管支架1-1变形，同时能防止血液从支架间隙流过；所述两端固定架为倒V型的记忆金属连接成的环，焊接在血管支架1-1两端；两端固定支架1-2的尖端部分为圆角，圆角上附有显影镀层1-5，显影镀层1-5为黄金镀层在X光照射下将导管支架1两端突出显示，帮助医生清楚的看出导管支架1所在位置；所述单向膜1-3为漏斗状软硅胶膜，前后开口，固定在血管支架1-1内，血液从主动脉流向肺动脉时，漏斗状软硅胶膜的窄端开口迎向血流方向，单向膜1-3受压缩窄端开口闭合阻止血液流通当肺动脉高压时，血液从肺动脉流向主动脉时，漏斗状软硅胶膜的大开口端迎向血流方向，血流能从单向膜1-3中通过降低肺动脉压力；所述记忆金属为镍钛记忆合金，镍钛记忆合金能在37℃变形为原状，适用于人体；网格的孔投影形状为菱形，网孔的变形法方向为菱形的孔横向延伸，竖向缩短，血管支架1-1直径变大贴合在导管内壁上，在手动压缩时横向缩短，竖向延伸，血管支架1-1直径变小，可收缩放置在输送系统2的鞘管2-1内；所述两端固定支架1-2的变形方向为以血管支架1-1底面为圆形向四周翘起，释放后两端固定支架1-2变形卡在导管两端固定稳导管支架1。
所述输送系统2包括鞘管2-1、导管2-2、推送杆2-3；所述鞘管2-1为塑料管，两端设有显影环2-5；尾端连接有导管2-2；所述导管2-2为血管介入导管2-2，头端连接鞘管2-1；所述推送杆2-3血管介入导丝，头端安装有推送块2-4；所述推送块2-4为圆柱塑料块，内径小于鞘管2-10.5mm。所述显影环2-5为不锈钢环，在X光下塑料的鞘管2-1能看到内部的导管支架1，显影环2-5辅助看到鞘管2-1的位置，推送过程中可见推送进程。
实施例Ⅱ
本发明的治疗动脉导管未闭重度肺动脉高压装置的使用方法如下：
(1)建立股静脉—下腔静脉—右心室—肺动脉通路；
(2)压缩血管支架1-1的直径，将两端固定支架1-2顺直，将导管支架1放置入鞘管2-1中：单向膜1-3的漏斗形状的窄端指向为从肺动脉指向右心室动脉；
(3)在X光下使用介入导丝引导鞘管2-1进入股静脉，沿着通路直达肺动脉，观看鞘管2-1两端显影环2-5判断鞘管2-1是否到右心室动脉导管内；
(4)退出导丝，推送杆2-3送入鞘管2-1未端的导管2-2中，捏住推送杆2-3，向后撤鞘管2-1，推送块2-4将导管支架1留在右心室动脉导管内；
(5)导管支架1的记忆金属恢复原状，血管支架1-1直径向外膨胀，两端固定支架1-2向四周翘起卡在右心室动脉导管两端；
(6)从通路中退出输送系统2。
上面所述的实施例仅仅是本发明的优选实施方式进行描述，并非对本发明的构思和范围进行限定，在不脱离本发明设计构思的前提下，本领域中普通工程技术人员对本发明的技术方案做出的各种变型和改进均应落入本发明的保护范围，本发明的请求保护的技术内容，已经全部记载在技术要求书中。
Claims (8)
1.一种治疗动脉导管未闭重度肺动脉高压装置，其特征在于：包括瓣膜支架、输送系统；
所述瓣膜支架包括血管支架、两端固定支架、单向膜；所述血管支架为圆管状，侧壁是记忆金属编织的网格，内壁附有塑料膜；所述两端固定架为倒V型的记忆金属连接成的环，焊接在血管支架两端；两端固定支架的尖端部分为圆角，圆角上附有显影镀层；所述单向膜为漏斗状生物瓣膜，前后开口，固定在血管支架内；
所述输送系统包括鞘管、导管、推送杆；所述鞘管为塑料管，两端设有显影环；尾端连接有导管；所述导管为血管介入导管，头端连接鞘管；所述推送杆血管介入导丝，头端安装有推送块；所述推送块为圆柱塑料块，内径小于鞘管0.5mm。
2.根据权利要求1所述的一种治疗动脉导管未闭重度肺动脉高压装置，其特征在于：所述记忆金属为镍钛记忆合金。
3.根据权利要求1所述的一种治疗动脉导管未闭重度肺动脉高压装置，其特征在于：所述网格的孔投影形状为菱形，网孔的变形法方向为菱形的孔横向延伸，竖向缩短。
4.根据权利要求1所述的一种治疗动脉导管未闭重度肺动脉高压装置，其特征在于：所述两端固定支架的变形方向为以血管支架底面为圆形向四周翘起。
5.根据权利要求1所述的一种治疗动脉导管未闭重度肺动脉高压装置，其特征在于：所述塑料膜为硅橡胶膜，显影镀层为黄金镀层。
6.根据权利要求1所述的一种治疗动脉导管未闭重度肺动脉高压装置，其特征在于：所述显影环为不锈钢环。
7.基于权利要求1～6所述的一种治疗动脉导管未闭重度肺动脉高压装置的使用方法，其特征在于，包括以下步骤：
(1)建立股静脉—下腔静脉—右心室—肺动脉—动脉导管—降主动脉通路；
(2)压缩血管支架的直径，将两端固定支架顺直，将导管支架放置入鞘管中：
(3)在X光下使用介入导丝引导鞘管进入股静脉，沿着通路直达肺动脉，观看鞘管两端显影环判断鞘管是否到动脉导管内；
(4)退出导丝，推送杆送入鞘管未端的导管中，捏住推送杆，向后撤鞘管，推送块将导管支架留在动脉导管内；
(5)导管支架的记忆金属恢复原状，血管支架直径向外膨胀，两端固定支架向四周翘起卡在动脉导管两端；
(6)从通路中退出输送系统。
8.根据权利要求7所述的一种治疗动脉导管未闭重度肺动脉高压装置的使用方法，其特征在于：所述单向膜的漏斗形状的窄端指向为从肺动脉指向主动脉。
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