CN114903656A - 肺动脉插入用三尖瓣返流手术用器械 - Google Patents
肺动脉插入用三尖瓣返流手术用器械 Download PDFInfo
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Abstract
本发明涉及一种肺动脉插入用三尖瓣返流手术用器械,包括:插入管,插入管配置成经由大腿静脉、下大静脉和三尖瓣而插入至肺动脉;以及阻断部,阻断部设置至插入管并且配置成能够随着插入管进行移动,以位于三尖瓣的位置来阻断三尖瓣的空间。
Description
技术领域
本发明涉及肺动脉插入用三尖瓣返流手术用器械,更详细而言,涉及一种用于确认是否发生当以手术或其他永久性治疗方法治疗三尖瓣返流时可能发生的右心室衰竭,以倾斜地贯通的方式试验性插入患者的三尖瓣,在经过既定时间后去除的肺动脉插入用三尖瓣返流手术用器械。
背景技术
三尖瓣返流(Tricuspid regurgitation)也称为三尖瓣关闭不全。三尖瓣返流作为一种三尖瓣病变,是指当三尖瓣应关闭时无法完全关闭而发生空间(orifice),当右心室收缩时,应从右心室排出到肺动脉的血液中一部分通过所述空间(orifice)逆流到右心房的症状。
以往,三尖瓣返流的治疗方式有打开患者胸腔并切开心脏而以手术方式进行矫正的方法和将美国授权专利US 8486136 B2、美国授权专利US 7854762B2及美国授权专利US9474605B2发明的三尖瓣返流手术器械永久性插入患者体内来治疗三尖瓣返流的方法。但是,当以所述手术法或永久性手术方法等治疗三尖瓣返流时,由于从右心室移动到肺动脉的血流突然增加,右心室发生过载,会发生出现右心室衰竭症状的问题。
发明内容
本发明正是为了解决如上所述问题而研发的,目的旨在提供一种能够通过大腿静脉-下大静脉-三尖瓣-肺动脉而简单地插入并倾斜地穿过三尖瓣的肺动脉插入用三尖瓣返流手术用器械。
另外,旨在提供一种只在既定时间期间,阻断三尖瓣的空间(orifice),可以确认患者的右心室是否发生过载的肺动脉插入用三尖瓣返流手术用器械。
本发明目的不限于以上提及的目的,未提及的其他目的是本发明技术领域的技术人员可以从以下记载明确理解的。
本发明为了达成上述目的,肺动脉插入用三尖瓣返流手术用器械包括:阻断部,所述阻断部倾斜地贯通三尖瓣;及插入管,所述插入管在内部形成有导丝引导管腔(lumen),以便能够沿着导丝而从下大静脉移动到肺动脉。
另外,肺动脉插入用三尖瓣返流手术用器械还包括能够将肺动脉插入用三尖瓣返流手术用器械临时固定于肺动脉的肺动脉固定装置。
所述肺动脉固定装置在下部包括肺动脉固定构件主体、呈辐射状结合于所述肺动脉固定构件主体的多个肺动脉固定体。
其特征在于,所述肺动脉固定构件主体以在中心轴上形成有孔的圆筒形形成,与所述插入管结合。
所述肺动脉固定构件主体还包括肺动脉凸出环,所述肺动脉凸出环结合于外周面,能够利用从外部插入的钩进行挂接。
所述肺动脉固定构件主体以环形形成,所述肺动脉固定构件包括固定构件连接丝,所述固定构件连接丝一端与所述肺动脉固定构件主体结合,插入所述插入管内。
所述肺动脉固定构件包括:肺动脉固定体,所述肺动脉固定体以具有带形状的丝线形成;肺动脉固定构件主体,所述肺动脉固定构件主体结合于所述肺动脉固定体。
其特征在于,所述肺动脉固定构件主体以在中心轴上形成有孔的圆筒形形成,与所述插入管结合。
所述肺动脉固定构件主体以环形形成,所述肺动脉固定构件包括固定构件连接丝,所述固定构件连接丝与所述肺动脉固定体结合,贯通以环形形成的所述肺动脉固定构件主体的中心轴而插入于所述插入管内。
所述阻断部包括:支撑丝线,所述支撑丝线两端结合于所述插入管;阻断膜(membrane),所述阻断膜一侧固定于所述插入管,被所述支撑丝线支撑。
所述阻断部为能够膨胀或收缩的气囊形态的阻断气囊,且还包括:气囊管,所述气囊管一端连接于所述阻断气囊并连通;气囊调节器,所述气囊调节器连接于所述气囊管的另一端,安装于患者的体外,使所述阻断气囊膨胀或收缩。
所述阻断部包括:环形丝线,所述环形丝线以所述连接管贯通的方式安装,中心轴与所述连接管倾斜地形成;阻断膜(membrane),所述阻断膜连接所述插入管与所述环形丝线。
另外,肺动脉插入用三尖瓣返流手术用器械为了移动到体内而还包括鞘管,所述鞘管形成有能够插入所述肺动脉插入用三尖瓣返流器械的管腔(lumen)。
本发明的肺动脉插入用三尖瓣返流手术用器械可以通过大腿静脉-下大静脉-三尖瓣-肺动脉而简单地插入。
另外,在插入永久性三尖瓣返流手术用器械之前,可以临时向患者体内插入三尖瓣返流手术用器械,确认右心室是否发生过载。
另外,如果确认了因患者右心室过载导致的异常现象,则可以简单地去除并复原右心室内的血压。
附图说明
图1是显示本发明优选实施例的肺动脉插入用三尖瓣返流手术用器械的立体图。
图2是显示利用本发明的肺动脉插入用三尖瓣返流手术用器械的肺动脉插入用三尖瓣返流手术步骤的顺序图。
图3是显示将肺动脉插入用三尖瓣返流手术用器械插入体内的过程的立体剖面图。
图4图示了在图1的肺动脉插入用三尖瓣返流手术用器械的一端安装有肺动脉固定构件的样子,(a)是显示第一实施例的肺动脉固定构件的立体图,(b)是显示第二实施例的肺动脉固定构件的立体图,(c)是显示第三实施例的肺动脉固定构件的立体图,及(d)是显示第四实施例的肺动脉固定构件的立体图。
图5是显示本发明另一优选实施例的肺动脉插入用三尖瓣返流手术用器械的立体图。
图6是显示本发明又一优选实施例的肺动脉插入用三尖瓣返流手术用器械的立体图。
附图标记
10:阻断部
12:阻断膜
14:支撑丝线
16:阻断气囊
17:气囊管
18:气囊调节器
19:环形丝线
37:插入管
22:导丝引导管腔
30:肺动脉固定构件
32:肺动脉固定体
34:肺动脉固定构件主体
36:肺动脉凸出环
38:固定构件连接丝
40:鞘管
50:导丝
100:肺动脉插入用三尖瓣返流手术用器械
S10:导丝移动步骤
S20:肺动脉插入用三尖瓣返流手术用器械移动步骤
S30:肺动脉插入用三尖瓣空间阻断步骤
S40:肺动脉插入用三尖瓣返流手术用器械去除步骤。
具体实施方式
参照下文中与附图一起详细说明的实施例,本发明的优点及特征以及实现它们的方法将会显而易见。但是,本发明并非限定于以下公开的实施例,可以以互不相同的多样形态体现,不过,本实施例提供用于使本发明的公开更完整,向本发明所属技术领域的技术人员完整地告知发明的范畴,本发明只由权利要求项的范畴所定义。
下面参照附图,详细说明实施本发明所需的具体内容。与附图无关,相同的构件标记指称相同的构成要素,“及/或”包括提及的各个项目及一个以上的所有组合。
本说明书中使用的术语用于说明实施例,并非要限制本发明。在本说明书中,只要在语句中未特别提及,单数型也包括复数型。说明书中使用的“包括(comprises)”及/或“包括的(comprising)”,不排除在提及的构成要素之外存在或添加一个以上的其他构成要素。
如果没有其他定义,则在本说明书中所使用的所有用语(包括技术用语及科技用语)能够以本发明所属技术领域的技术人员共同理解的含义使用。另外,一般使用的字典定义的术语,只要未明确地特别定义,不得过于或过度地解释。
下面参照附图,详细说明本发明优选实施例。
图1是显示本发明优选实施例的肺动脉插入用三尖瓣返流手术用器械的立体图。
如果参照图1,肺动脉插入用三尖瓣返流手术用器械100包括:阻断部10、形成有导丝引导管腔22的插入管20。
所述阻断部10包括:支撑丝线14,所述支撑丝线14两端固定于所述插入管20;阻断膜12,所述阻断膜12连接所述插入管20与所述支撑丝线14。当然,所述支撑丝线14也可以是两侧或一侧未固定于所述插入管20的情形。
所述阻断膜12使用具有柔性、不易撕裂、适合人体的材质,可以使用医疗用聚氨酯、聚烯烃、硅树脂、e-PTFE(膨体聚四氟乙烯)、PTFE(聚四氟乙烯)等。
所述支撑丝线14用于保持所述阻断膜12的形态,可以使用尼龙等合成树脂或金属制(不锈钢,在金属上涂覆尼龙等)丝线等。所述支撑丝线14既可以为一条丝线,当然也可以是由多条丝线捻成的形态。所述阻断膜12以双重形成,也可以以所述支撑丝线14插入于所述阻断膜12的形态构成。
所述阻断膜12如图1所示,不仅可以是半圆形态,还可以为圆形形态,为了调节圆形形态的所述阻断膜12的位置或固定其形态,也可以安装多个所述插入管20。
形成有所述导丝引导管腔22的所述插入管20可以为橡胶材料、柔性塑料材料等,使用柔性高、可随心脏跳动而移动的柔软性和复原性优秀的材质。
图2是显示利用本发明的肺动脉插入用三尖瓣返流手术用器械的肺动脉插入用三尖瓣返流手术步骤的顺序图,图3是显示将肺动脉插入用三尖瓣返流手术用器械插入体内的过程的立体剖面图。
如果参照图2及图3,肺动脉插入用三尖瓣返流手术步骤包括导丝移动步骤S10、肺动脉插入用三尖瓣返流手术用器械移动步骤S20、三尖瓣空间阻断步骤S30及肺动脉插入用三尖瓣返流手术用器械去除步骤S40。
所述导丝移动步骤S10是用于使所述导丝50沿大腿静脉-下大静脉-三尖瓣-肺动脉移动而容易地进行本发明的肺动脉插入用三尖瓣返流手术用器械100移动的步骤。丝线及导管在体内的移动可以通过X射线观察。为了使所述导丝50安全地移动到体内,需要在内部形成有管腔(lumen)的导丝引导管(图上未示出)。所述导丝引导管(图上未示出)为了穿过三尖瓣的安全区(safe zone)而在上端包括气囊或猪尾巴形态的挂接装置。在三尖瓣的周围,具有诸如三尖瓣小叶(leaflet)、三尖瓣腱索(chordae)及乳头肌(papillary)的瓣膜下部结构物及节制索(moderator band),将这种空间称为不安全区(unsafe zone)。所述安全区(safe zone)是指在所述不安全区(unsafe zone)之外的即使丝线或导管穿过也不会给人体造成损伤的安全之处。所述挂接装置在通过所述不安全区(unsafe zone)移动时,卡于瓣膜下部结构物及节制索而导致无法前进,只能通过所述安全区(safe zone)移动。因此,将所述导丝引导管(图上未示出)沿大腿静脉-下大静脉-三尖瓣的安全区-肺动脉插入后,在所述导丝引导管(图上未示出)中插入所述导丝50,安全地移动到体内。如果所述导丝50到达肺动脉,则停止移动,将所述导丝引导管(图上未示出)去除到体外。此时,准备肺动脉插入用三尖瓣返流手术用器械100,使得能够插入于在内部形成有管腔的鞘管40,并移动到体内。
所述肺动脉插入用三尖瓣返流手术用器械移动步骤S20是使所述导丝50插入于在所述插入管20内形成的所述导丝引导管腔22,使肺动脉插入用三尖瓣返流手术用器械100移动到患者体内的步骤。插入于所述鞘管40内的肺动脉插入用三尖瓣返流手术用器械100沿着所述导丝50在体内移动的路径(大腿静脉-下大静脉-三尖瓣-肺动脉)移动。
三尖瓣空间阻断步骤S30是将本发明的肺动脉插入用三尖瓣返流手术用器械100插入患者体内,所述阻断部10阻断三尖瓣空间(orifice)的步骤。所述阻断部10倾斜地贯通三尖瓣后,将所述导丝50及所述鞘管40去除到体外,所述阻断部10阻断三尖瓣空间既定时间。
所述肺动脉插入用三尖瓣返流手术用器械去除步骤S40是确认患者是否出现诸如右心室衰竭的异常症状并判断能否进行永久性手术后,将肺动脉插入用三尖瓣返流手术用器械100去除到患者体外的步骤。阻断三尖瓣空间后,如果经过既定时间也未出现异常症状,则将所述鞘管40重新插入体内。使肺动脉插入用三尖瓣返流手术用器械100插入所述鞘管40内部,将插入于所述鞘管40内的肺动脉插入用三尖瓣返流手术用器械100去除到体外。在出现异常状况时,立即将肺动脉插入用三尖瓣返流手术用器械100去除到体外。
根据所述步骤,可以在对三尖瓣返流患者永久性治疗三尖瓣返流之前,临时阻断三尖瓣空间,确认能否进行永久性三尖瓣返流治疗。
图4图示了在图1的肺动脉插入用三尖瓣返流手术用器械的一端安装有肺动脉固定构件的样子,(a)是显示第一实施例的肺动脉固定构件的立体图,(b)是显示第二实施例的肺动脉固定构件的立体图,(c)是显示第三实施例的肺动脉固定构件的立体图,及(d)是显示第四实施例的肺动脉固定构件的立体图。
如果参照图4,本发明的肺动脉插入用三尖瓣返流手术用器械100可以在上端还包括肺动脉固定构件30。
首先,如果参照图4的(a),第一实施例的肺动脉固定构件30在下部包括肺动脉固定构件主体34、呈辐射状结合于所述肺动脉固定构件主体34的多个肺动脉固定体32。所述肺动脉固定构件主体34的特征在于,以在中心轴上形成有孔的圆筒形形成,具有与所述插入管20的外周面紧密结合的内周面,并插入结合于所述插入管20。另外,也可以追加在所述肺动脉固定构件主体34的外周面形成的环形态的肺动脉凸出环36。
如果参照图4的(b),第二实施例的肺动脉固定构件30在下部包括环形的肺动脉固定构件主体34、呈辐射形结合于所述肺动脉固定构件主体34上端的多个肺动脉固定体32、一端结合于所述肺动脉固定构件主体34并插入于所述插入管20的固定构件连接丝38。
所述第一实施例及所述第二实施例的肺动脉固定体32可以由弹性体或形状记忆合金或自膨胀式支架(self expandable stent)构成,为了移动到体内,在插入于所述鞘管40内时,以收紧状态插入,去除所述鞘管40时复原,呈辐射状展开,固定于肺动脉。
如果参照图4的(c),第三实施例的肺动脉固定构件30包括:肺动脉固定体32,所述肺动脉固定体32以具有中心部凸出的带形状的丝线形成;肺动脉固定构件主体34,所述肺动脉固定构件主体34结合于所述肺动脉固定体32的下端;肺动脉凸出环36,所述肺动脉凸出环36在所述肺动脉固定构件主体34的外周面形成。所述肺动脉固定构件主体34的特征在于,以在中心轴上形成有孔的圆筒形形成,具有与所述插入管20的外周面紧密结合的内周面,并插入结合于所述插入管20。
第三实施例的以具有中心部凸出的带形状的丝线形成的肺动脉固定体32,可以由弹性体或形状记忆合金或自膨胀式支架(self expandable stent)构成,为了移动到体内,在插入于所述鞘管40内时,以中心部被按压的状态插入,去除所述鞘管40时凸出地复原,固定于肺动脉。
如果参照图4的(d),第四实施例的肺动脉固定构件30包括:肺动脉固定体32,所述肺动脉固定体32以具有带形状的丝线形成;肺动脉固定构件主体34,所述肺动脉固定构件主体34结合于所述肺动脉固定体32的下端,以环形形成;固定构件连接丝38,所述固定构件连接丝38一端结合于所述肺动脉固定体32,贯通所述肺动脉固定构件主体34的中心轴而插入于所述插入管20。
第四实施例的以带子形态形成的肺动脉固定体32,为了插入到体内而插入于所述鞘管40内,并移动到体内,在去除所述鞘管40时,将所述肺动脉固定体32或所述肺动脉固定构件主体34推向前侧,成为中心部凸出的带子形状的所述肺动脉固定体32,固定于肺动脉。
当然也可以是除上述形态的肺动脉固定构件30之外的其他形态。另外,所述肺动脉固定构件30也可以结合于所述插入管20的下端,固定于下大静脉。
去除所述肺动脉固定构件30时,有如下去除方法,将所述鞘管40再插入体内,将肺动脉插入用三尖瓣返流手术用器械100插入于所述鞘管40并去除,或将上端为钩形态的丝线(图上未示出)追加插入体内后,挂接于所述肺动脉凸出环36而拉出体外。
肺动脉插入用三尖瓣返流手术用器械100当然也可以不安装所述肺动脉固定构件30。
图5是显示本发明另一优选实施例的肺动脉插入用三尖瓣返流手术用器械的立体图。
如果参照图5,本发明另一优选实施例的肺动脉插入用三尖瓣返流手术用器械100包括形成有管腔22的插入管20、阻断部10。所述插入管20与在图1中详细叙述的内容相同,所述阻断部10包括:阻断气囊16,所述阻断气囊16结合于所述插入管20的一侧;气囊管17,所述气囊管17一端与所述阻断气囊16连接、连通;气囊调节器18,所述气囊调节器18结合于所述气囊管17的另一端,调节所述阻断气囊16使得可以膨胀或收缩。所述气囊调节器18安装于患者的体外,所述阻断气囊16可以借助于所述气囊调节器18供应的空气、氧气、泡沫(Form)等而膨胀或收缩。
所述肺动脉插入用三尖瓣返流手术用器械100可以还包括肺动脉固定构件30,所述肺动脉固定构件30与在图4中详细叙述的内容相同。
所述肺动脉固定构件30的第二实施例及第四实施例在移动到体内时,也可以不插入于所述鞘管40,而是可以将所述固定构件连接丝38拉向下侧,插入于所述插入管20并移动后,如果移动停止,则将所述固定构件连接丝38推向上侧,将所述肺动脉固定构件30拔出到所述插入管20外部,固定于肺动脉。
图6是本发明又一优选实施例的肺动脉插入用三尖瓣返流手术用器械的立体图。
如果参照图6,本发明另一优选实施例的肺动脉插入用三尖瓣返流手术用器械100包括形成有管腔22的插入管20、阻断部10。所述插入管20与在图1中详细叙述的内容相同,所述阻断部10包括:环形丝线19,所述环形丝线19以所述连接管20贯通的方式安装,中心轴与所述连接管20倾斜地形成;阻断膜(membrane)12,所述阻断膜12连接所述插入管19与所述环形丝线20。
所述肺动脉插入用三尖瓣返流手术用器械100可以还包括肺动脉固定构件30,所述肺动脉固定构件30与在图4中详细叙述的内容相同。
所述环形丝线19倾斜既定角度倾斜地安装于所述插入管20,因而与三尖瓣平行地配置。因此,可以有效地阻断三尖瓣的空间(orifice)。
以上参考附图对本发明的实施例进行了说明,但是本发明所属技术领域的技术人员能够理解在不改变本发明的技术思想或必要特征的前提下,本发明可以以其他具体形态实施。因此,以上记述的实施例在所有方面应理解为只是示例而非限定。
Claims (10)
1.一种肺动脉插入用三尖瓣返流手术用器械,其特征在于,包括:
插入管,所述插入管配置成经由大腿静脉、下大静脉和三尖瓣而插入至肺动脉;以及
阻断部,所述阻断部设置至所述插入管并且配置成能够随着所述插入管进行移动,以位于所述三尖瓣的位置来阻断所述三尖瓣的空间。
2.如权利要求1所述的三尖瓣返流手术用器械,其特征在于,所述阻断部包括:
支撑丝线,所述支撑丝线固定至所述插入管;以及
阻断膜,所述阻断膜的形态配置成由所述支撑丝线保持,以便阻断所述三尖瓣的空间。
3.如权利要求1所述的三尖瓣返流手术用器械,其特征在于,所述阻断部包括:阻断气囊,所述阻断气囊能够被调节为膨胀或收缩,以便在所述阻断气囊膨胀时阻断所述三尖瓣的空间。
4.如权利要求1所述的三尖瓣返流手术用器械,其特征在于,所述阻断部包括:
环形丝线,所述环形丝线以所述插入管贯通的方式安装;以及
阻断膜,所述阻断膜连接至所述插入管与所述环形丝线,以便阻断所述三尖瓣的空间。
5.如权利要求4所述的三尖瓣返流手术用器械,其特征在于,所述环形丝线的中心轴设置成相对于所述插入管倾斜。
6.如权利要求1至5中任一项所述的三尖瓣返流手术用器械,其特征在于,所述阻断部倾斜地贯通所述三尖瓣。
7.如权利要求6所述的三尖瓣返流手术用器械,其特征在于,还包括固定构件,所述固定构件配置成将所述三尖瓣反流手术用器械固定至所述肺动脉。
8.如权利要求7所述的三尖瓣反流手术用器械,其特征在于,所述固定构件包括:
固定体,所述固定体配置成能够固定至所述肺动脉;以及
固定主体,所述固定主体与所述插入管结合,并且与所述固定体结合。
9.如权利要求7所述的三尖瓣反流手术用器械,其特征在于,所述固定构件包括:
固定体,所述固定体配置成能够固定至所述肺动脉;
固定主体,所述固定主体与所述固定体结合;以及
连接丝,所述连接丝插入所述插入管中并且与所述固定主体结合。
10.如权利要求8或9所述的三尖瓣反流手术用器械,其特征在于,
所述固定体为辐射状结合至所述固定主体的多个固定体;或者
所述固定体为结合至所述固定主体的带形状的丝线。
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CN115137529A (zh) | 2016-12-21 | 2022-10-04 | 特里弗洛心血管公司 | 心脏瓣膜支撑装置及用于制造和使用该装置的方法 |
KR101965637B1 (ko) | 2017-07-31 | 2019-04-03 | (주) 타우피엔유메디칼 | 폐동맥 삽입용 삼첨판막 역류증 시술용 기구 |
KR102156647B1 (ko) | 2019-01-21 | 2020-09-16 | (주) 타우피엔유메디칼 | 조립형 삼첨판막 역류증 시술용 기구 |
KR102268993B1 (ko) * | 2019-05-16 | 2021-06-24 | (주) 타우피엔유메디칼 | 위치고정튜브를 구비한 삼첨판막 역류증 시술용 기구 |
US10842628B1 (en) | 2019-05-22 | 2020-11-24 | TriFlo Cardiovascular Inc. | Heart valve support device |
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JP7019937B2 (ja) | 2022-02-16 |
CN110996852A (zh) | 2020-04-10 |
EP3662867B1 (en) | 2023-12-20 |
US20230149169A1 (en) | 2023-05-18 |
EP3662867A2 (en) | 2020-06-10 |
US20210085451A1 (en) | 2021-03-25 |
WO2019027183A2 (ko) | 2019-02-07 |
KR101965637B1 (ko) | 2019-04-03 |
JP2020529241A (ja) | 2020-10-08 |
WO2019027183A3 (ko) | 2019-03-28 |
US11576781B2 (en) | 2023-02-14 |
KR20190012936A (ko) | 2019-02-11 |
EP3662867A4 (en) | 2021-05-19 |
EP4324507A3 (en) | 2024-04-17 |
EP4324507A2 (en) | 2024-02-21 |
CN110996852B (zh) | 2022-06-21 |
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