CN108836575B - 一种用于微创手术进行瓣叶修复的系统 - Google Patents

一种用于微创手术进行瓣叶修复的系统 Download PDF

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CN108836575B
CN108836575B CN201810414365.7A CN201810414365A CN108836575B CN 108836575 B CN108836575 B CN 108836575B CN 201810414365 A CN201810414365 A CN 201810414365A CN 108836575 B CN108836575 B CN 108836575B
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CN108836575A (zh
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代高旭
李阳
杨宇霆
周庆亮
可大年
孟坚
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Beijing medipeak Medical Technology Co.,Ltd.
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BEIJING MAIDI DINGFENG MEDICAL TECHNOLOGY Co Ltd
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Priority to KR1020207010194A priority patent/KR102376568B1/ko
Priority to PCT/CN2018/110684 priority patent/WO2019076325A1/zh
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    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
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    • A61F2/00Filters 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
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
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    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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Abstract

本发明公开了一种用于微创手术进行瓣叶修复的系统,所述的系统包括可实现联动释放操作的输送器和修复部件。所述输送器包括操作手柄、定位鞘、外管夹、外输送管、输送针、推送管;所述操作手柄内设有三层套管,由内至外分别为推送管、输送针、外输送管;所述操作手柄包括拉杆、推柄、持柄;所述拉杆外部套设有推柄,所述推柄外部套设有持柄;所述操作手柄内从左自右延长方向上依次设有第一管座、第二管座、第三管座;所述拉杆与第一管座连接,所述推柄与第二管座连接;所述持柄与第三管座连接。本发明适用于微创手术中瓣叶的修复,操作简单,且可实现一键释放及修复操作,降低术中操作难度和患者痛苦。

Description

一种用于微创手术进行瓣叶修复的系统
技术领域
本发明涉及医疗器械技术领域,尤其涉及一种用于微创手术进行瓣叶修复的系统。
背景技术
微创手术对人体造成的创伤小,是一种应用越来越广泛的医疗技术,而许多微创植入器械需要通过操作手柄来完成很多复杂的步骤才能实现器械植入,如何让术者更简单方便的完成这些步骤是微创器械的一个发展方向。
正常的瓣膜可保障血液单向顺畅流动,能有效将腔室的血液泵出而不回流。很多种疾病,如风湿性心脏病,心内膜炎引起瓣膜的病变使瓣膜的功能受到损害,狭窄和返流是常见的瓣膜性疾病。狭窄是由于瓣膜不能完全打开,导致血流受阻,瓣叶的钙化导致的增厚是引起狭窄的常见原因。返流是由于瓣叶不能完全关闭,导致血液回流到泵血的腔室,瓣环扩张、瓣叶脱垂、瓣叶活动受阻是引起返流的主要原因。
二尖瓣和三尖瓣由附着在瓣环的小叶组成,这些小叶在游离缘处被腱索支撑,腱索附着在心室内壁和乳头肌。然而,有时人工腱索弹射后还处于“一”字型易从瓣叶上脱离。
中国实用新型专利(一种医用器件操作手柄:201020161849.4),包括导向杆,导向杆设有滑槽,推进器设有滑块,滑块与滑槽滑动连接,推进器与导向杆之间设有锁定装置。推进器内设有锁定杆安装孔,锁定杆安装孔内设有锁定杆外套,锁定杆外套侧面间隔设置有锁定锯齿和解锁槽,锁定锯齿和解锁槽之间通过斜面连接,锁定杆中部设有凸环,锁定杆外套套在该凸环外,凸环两端设有锯齿形边,凸环外侧面设有与解锁槽相配合的纵向凸块,凸环与锁定杆安装孔之间设有弹簧,导向杆设有与锁定杆相配合的多个锁定孔。该专利虽然结构简单,操作方便,但是不能发生意外而及时暂停操作手柄,防止误操作带来的严重后果。
在现有的操作手柄中,管和管座间透气不密封及管易从管座上脱离,而且操作手柄中按键较多,且位置相近,容易产生误操作导致的非预期的按键触发,且有突发状况发生时,不能及时暂停操作手柄。
发明内容
为解决现有技术中存在的问题,本发明提供了一种用于微创手术进行瓣叶修复的系统,操作简单,且可实现一键释放及修复操作,降低术中操作难度和患者痛苦。
为解决上述技术问题,本发明采用的技术方案是:一种用于微创手术进行瓣叶修复的系统,包括输送器、修复部件,其特征在于,所述修复部件与所述输送器连接;所述输送器包括操作手柄、定位鞘、外管夹、外输送管、输送针、推送管;
所述操作手柄内设有三层套管,由内至外分别为推送管、输送针、外输送管;所述操作手柄包括拉杆、推柄、持柄;
所述拉杆外部套设有推柄,所述推柄外部套设有持柄;
所述操作手柄内从左自右延长方向上依次设有第一管座、第二管座、第三管座;所述拉杆与第一管座连接,所述推柄与第二管座连接;
所述推送管的一端与第一管座连接,另一端贯穿第二管座的中心;
所述输送针的一端与第二管座连接,另一端贯穿第三管座的中心;
所述外输送管的一端与第三管座连接;另一端贯穿外管夹与所述定位鞘的中心,所述修复部件包括锚定件、连接线,所述锚定件与所述连接线连接。
优选地,所述第一管座上设有第一卡槽,所述推送管上设有第一卡片,所述第一卡槽与第一卡片结构配合;
所述第二管座上设有第二卡槽,所述输送针上设有第二卡片,所述第二卡槽与第二卡片结构配合;
所述第三管座上设有第三卡槽,所述外输送管上设有第三卡片,所述第三卡槽与第三卡片结构配合。
优选地,所述拉杆的外侧与所述推柄的内侧套设有第一弹簧机构,可以通过第一弹簧机构配合传动;
所述推柄的外侧与所述持柄的内侧套设有第二弹簧机构,可以通过第二弹簧机构配合传动。
优选地,所述拉杆上设有排空接口、拉平装置、管状结构以及可在推柄内滑动的第一滑键,所述管状结构可封血可剪断并使连接线脱离;
所述拉平装置包括线夹和弹簧,所述线夹和连接线连接;
优选地,所述推柄内设有供拉杆滑动的第一滑槽,所述第一滑槽与第一滑键相适配;推柄外设有可在持柄内滑动的第二滑键;
所述推柄左侧设有方形结构,所述方形结构内设有卡键,所述卡键的下端设有第二弹簧,在第二弹簧力的作用下实现对所述拉杆的锁定。
优选地,所述持柄的前端设有按键,所述按键的下端设有第三弹簧,拉开推柄后,按键在第三弹簧力的作用下将推柄锁定,触发按键后即可触发所述推柄弹射。
优选地,所述持柄设有滑动键及供推柄滑动的第二滑槽,所述第二滑槽与第二滑键相适配;所述滑动键位于持柄的尾部,推柄拉开后,所述滑动键可自动滑动到释放位置在所述推柄弹射时用于解锁所述卡键进而触发所述拉杆弹射。
优选地,所述持柄上还设有安全按键、安全按键复位孔,所述安全按键与所述按键相邻设置,所述安全按键复位孔与所述安全按键相邻设置,所述安全按键尾部设有第四弹簧,通过第四弹簧力的作用保持安全按键的锁定,所述安全按键复位孔用于安全按键解锁后的复位。
优选地,所述定位鞘与所述外管夹配合使用,使所述定位鞘的端面与所述外输送管端面平齐。
优选地,所述锚定件由金属或高分子材料组成,用于锚定在瓣叶上;
所述连接线由膨体聚四氟乙烯、聚酯或其他高分子材料制成。
与现有技术相对比,本发明产生的有益效果是:
(1)本发明提供的一种用于微创手术进行瓣叶修复的系统,操作简单,且可实现一键释放及修复操作,降低术中操作难度和患者痛苦。
(2)本发明提供的一种用于微创手术进行瓣叶修复的系统,在心脏不停跳的情况下完成手术,该手术可以借助现代影像设备如胸腔镜、腹腔镜的导航功能准确的修复瓣叶功能。
(3)本发明提供的一种用于微创手术进行瓣叶修复的系统,在心脏不停跳的手术情况下,完成瓣叶的修复,该过程可容易测算瓣叶修复的效果,植入操作更简单,可降低对术者手术强度和难度,提高手术成功率。
(4)本发明提供的安全按键可以防止误操作导致的非预期的按键触发;在安全按键解除保护后,如有突发状况需要暂停手柄操作时,安全按键复位孔可以使安全按键重新恢复到保护状态。
(5)本发明的操作手柄设置的拉平装置,可使人工腱索释放后自动拉平成“T”字形结构,避免了人工腱索弹射后还处于“一”字型易从瓣叶上脱离。
(6)本发明提供的操作手柄由三层套管组成,三层套管均由管和管座两部分组成,三个管上均有一个卡片结构,三个管座上均有一个卡槽结构。管的卡片结构以下部分通过涂胶与管座粘接,同时管的卡片结构与管座的卡槽结构配合。结构优点:胶粘可使管和管座密封且防止管转动及管从管座上脱离,卡片卡槽配合能防止弹射过程中冲击力使管移位脱离管座。
附图说明
图1是本发明提供的操作手柄的剖视图;
图2是本发明提供的输送器非操作手柄部分的结构示意图;
图3是本发明提供的瓣叶修复系统的头端剖视图;
图4是本发明提供的第一管座与推送管分解图;
图5是本发明提供的第二管座与输送针分解图;
图6是本发明提供的第三管座与外输送管分解图;
图7是本发明提供的拉杆的部分结构图;
图8是本发明提供的第一滑槽位置图;
图9是本发明提供的第二滑槽位置图;
图10是本发明提供的第二滑键位置图;
图11是本发明提供的部分操作手柄立体结构图;
图12是本发明提供的操作手柄立体结构图;
图13是本发明提供的操作手柄的剖视图;
附图中标记的具体含义如下:
1.拉杆;2.推柄;3.持柄;4.管状结构;5.卡键;6.滑动键;7.按键;8.安全按键;9.外输送管;10.输送针;11.推送管;12.第一弹簧机构;13.第二弹簧机构;14.第一管座;15.第二管座;16.第三管座;17.排空接口;18.第一滑键;19.定位鞘;20.外管夹;21.修复部件;22.第一卡槽;23.第二卡槽;24.第三卡槽;25.第一卡片;26.第二卡片;27.第三卡片;28.线夹;29.弹簧;30.第一滑槽;31.第二滑槽;32.第二滑键;33安全按键复位孔。
具体实施方式
下面结合附图,对本发明的具体实施方式作详细的说明。
参图1所示,图1为本发明提供的操作手柄结构示意图。本发明提供的一种用于微创手术进行瓣叶修复的系统,包括输送器、修复部件21,修复部件21与输送器连接;其中修复部件21包括锚定件、连接线,锚定件与连接线连接。修复部件21的连接线穿过推送管11连接到拉杆1的线夹28上,锚定件放置在推送管11端部,置于输送针12内部。其中,锚定件由金属或高分子材料组成,用于锚定在瓣叶上;连接线由膨体聚四氟乙烯、聚酯或其他高分子材料制成。
输送器包括操作手柄、定位鞘19、外管夹20、外输送管9、输送针10、推送管11;
操作手柄内设有三层套管,由内至外分别为推送管11、输送针10、外输送管9;定位鞘19套设在外输送管9外面,外输送管9套设在输送针10外面,推送管11位于输送针10内部用于修复部件的释放;操作手柄包括拉杆1、推柄2、持柄3;拉杆1外部套设有推柄2,拉杆1的外侧与推柄2的内侧套设有第一弹簧机构12,可以通过第一弹簧机构配合传动;推柄2外部套设有3持柄;推柄2的外侧与持柄3的内侧套设有第二弹簧机构13,可以通过第二弹簧机构配合传动;操作手柄内从左自右延长方向上依次设有第一管座14、第二管座15、第三管座16;拉杆1与第一管座14连接,推柄2与第二管座15连接;推送管11的一端与第一管座14连接,另一端贯穿第二管座15的中心;输送针10的一端与第二管座15连接,另一端贯穿第三管座16的中心;外输送管9的一端与第三管座16连接;另一端贯穿外管夹20与定位鞘19的中心;其中,第一管座14上设有第一卡槽22,推送管11上设有第一卡片25,第一卡槽22与第一卡片25结构配合;第一卡片25以下的推送管11部分通过涂胶与第一管座14粘接;第二管座15上设有第二卡槽23,输送针10上设有第二卡片26,第二卡片26以下的输送针10部分通过涂胶与第二管座15粘接;第二卡槽23与第二卡片26结构配合;第三管座16上设有第三卡槽24,外输送管9上设有第三卡片27,第三卡片27以下的外输送管9部分通过涂胶与第三管座16粘接,第三卡槽24与第三卡片27结构配合;胶粘可使管和管座密封且防止管转动及管从管座上脱离,卡片卡槽配合能防止弹射过程中冲击力使管移位脱离管座。
拉杆1上设有排空接口17、拉平装置、管状结构4以及可在推柄2内滑动的第一滑键18,管状结构4可封血可剪断并使连接线脱离;剪断管状结构4和修复部件21连接线部分后即可实现修复部件21从输送器的脱离。拉平装置端口设有排空接口17;拉平装置包括线夹28和弹簧29,线夹28和连接线连接;
推柄2内设有弹射拉杆1的第一弹簧机构,推柄2内还设有供拉杆滑动的第一滑槽30,第一滑槽30与第一滑键18相适配;推柄2外设有可在持柄3内滑动的第二滑键31;
推柄2左侧设有方形结构,方形结构内设有卡键5,卡键5可沿方形结构内的滑槽上下运动,卡键5的下端设有第二弹簧,在第二弹簧力的作用下实现对所述拉杆1的锁定。
按键7位于持柄3的前端,通过持柄3前端内部的滑槽实现上下运动,按键7的下端设有第三弹簧,在第三弹簧力的作用下保持对推柄2的锁定。
持柄3设有滑动键6及供推柄2滑动的第二滑槽31,第二滑槽31与第二滑键32相适配;滑动键6位于持柄3的尾部,通过持柄3尾部的滑槽及导柱以及弹簧的弹力作用下实现运动。推柄2拉开后,滑动键6可自动滑动到释放位置,在推柄2弹射时用于解锁卡键5进而触发拉杆1,在弹簧力的作用下实现拉杆1的向前弹射。
持柄3上还设有安全按键8、安全按键复位孔33,安全按键8与按键相邻设置,安全按键复位孔33与安全按键8相邻设置,安全按键8通过持柄3前端内部的滑槽进行滑动,安全按键8用于防止按键的误操作,导致修复部件14的非预期释放;安全按键复位孔33用于安全按键8解锁后的复位。
定位鞘19与外管夹20配合使用,使定位鞘19的端面与外输送管9的端面平齐;实现术中封血及对植入位置瓣叶的保护。
上文所述的一系列的详细说明仅仅是针对本发明的可行性实施方式的具体说明,它们并不是用以限制本发明的保护范围,在所述技术领域普通技术人员所具备的知识范围内,在不脱离本发明宗旨的前提下作出的各种变化均属于本发明的保护范围。

Claims (8)

1.一种用于微创手术进行瓣叶修复的系统,包括输送器、修复部件,其特征在于,所述修复部件与所述输送器连接;所述输送器包括操作手柄、定位鞘、外管夹、外输送管、输送针、推送管;
所述操作手柄内设有三层套管,由内至外分别为推送管、输送针、外输送管;所述操作手柄包括拉杆、推柄、持柄;
所述拉杆外部套设有推柄,所述推柄外部套设有持柄;
所述操作手柄内从左自右延长方向上依次设有第一管座、第二管座、第三管座;所述拉杆与第一管座连接,所述推柄与第二管座连接,所述持柄与第三管座连接;
所述推送管的一端与第一管座连接,另一端贯穿第二管座的中心;
所述输送针的一端与第二管座连接,另一端贯穿第三管座的中心;
所述外输送管的一端与第三管座连接;另一端贯穿外管夹与所述定位鞘的中心;
所述修复部件包括锚定件、连接线,所述锚定件与所述连接线连接;
所述第一管座上设有第一卡槽,所述推送管上设有第一卡片;第一卡片以下的推送管部分通过涂胶与第一管座粘接;所述第一卡槽与第一卡片结构配合;所述第二管座上设有第二卡槽,所述输送针上设有第二卡片,第二卡片以下的输送针部分通过涂胶与第二管座粘接,所述第二卡槽与第二卡片结构配合;所述第三管座上设有第三卡槽,所述外输送管上设有第三卡片,第三卡片以下的外输送管部分通过涂胶与第三管座粘接,所述第三卡槽与第三卡片结构配合;
所述拉杆上设有排空接口、拉平装置、管状结构以及可在推柄内滑动的第一滑键,所述管状结构可封血可剪断使连接线脱离输送器;
所述拉平装置包括线夹和第一弹簧,所述线夹和连接线连接。
2.如权利要求1所述一种用于微创手术进行瓣叶修复的系统,其特征在于,
所述拉杆的外侧与所述推柄的内侧套设有第一弹簧机构,可以通过第一弹簧机构配合传动;
所述推柄的外侧与所述持柄的内侧套设有第二弹簧机构,可以通过第二弹簧机构配合传动。
3.如权利要求1所述一种用于微创手术进行瓣叶修复的系统,其特征在于,所述推柄内设有供拉杆滑动的第一滑槽,所述第一滑槽与第一滑键相适配;推柄外设有可在持柄内滑动的第二滑键;
所述推柄左侧设有方形结构,所述方形结构内设有卡键,所述卡键的下端设有第二弹簧,在第二弹簧力的作用下实现对所述拉杆的锁定。
4.如权利要求1所述一种用于微创手术进行瓣叶修复的系统,其特征在于,所述持柄的前端设有按键,所述按键的下端设有第三弹簧,拉开推柄后,按键在第三弹簧力的作用下将推柄锁定,触发按键后即可触发所述推柄弹射。
5.如权利要求3所述一种用于微创手术进行瓣叶修复的系统,其特征在于,所述持柄设有滑动键及供推柄滑动的第二滑槽,所述第二滑槽与第二滑键相适配;所述滑动键位于持柄的尾部,推柄拉开后,所述滑动键可自动滑动到释放位置在所述推柄弹射时用于解锁所述卡键进而触发所述拉杆弹射。
6.如权利要求1所述一种用于微创手术进行瓣叶修复的系统,其特征在于,所述持柄上还设有安全按键、安全按键复位孔,所述安全按键与所述按键相邻设置,所述安全按键复位孔与所述安全按键相邻设置,所述安全按键尾部设有第四弹簧,通过第四弹簧力的作用保持安全按键的锁定,所述安全按键复位孔用于安全按键解锁后的复位。
7.如权利要求1所述一种用于微创手术进行瓣叶修复的系统,其特征在于,所述定位鞘与所述外管夹配合使用,使所述定位鞘的端面与所述外输送管端面平齐。
8.如权利要求1所述一种用于微创手术进行瓣叶修复的系统,其特征在于,所述锚定件由金属或高分子材料组成,用于锚定在瓣叶上;
所述连接线由膨体聚四氟乙烯、聚酯或其他高分子材料制成。
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US11678984B2 (en) 2023-06-20

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