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CN107822743A - 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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CN107822743A
CN107822743A CN201710985383.6A CN201710985383A CN107822743A CN 107822743 A CN107822743 A CN 107822743A CN 201710985383 A CN201710985383 A CN 201710985383A CN 107822743 A CN107822743 A CN 107822743A
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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 MAIDI DINGFENG MEDICAL TECHNOLOGY Co Ltd
Beijing Med Zenith Medical Scientific Co Ltd
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BEIJING MAIDI DINGFENG MEDICAL TECHNOLOGY Co Ltd
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Priority to CN201710985383.6A priority Critical patent/CN107822743A/zh
Publication of CN107822743A publication Critical patent/CN107822743A/zh
Priority to CN201810414365.7A priority patent/CN108836575B/zh
Priority to EP18869140.6A priority patent/EP3698759B1/en
Priority to PCT/CN2018/110684 priority patent/WO2019076325A1/zh
Priority to KR1020207010194A priority patent/KR102376568B1/ko
Priority to JP2020540666A priority patent/JP6971408B2/ja
Priority to US16/852,006 priority patent/US11678984B2/en
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    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
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    • 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
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    • 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
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    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
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    • 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
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    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2463—Implants forming part of the valve leaflets
    • A—HUMAN NECESSITIES
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    • A61F2220/00—Fixations 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

本发明提供了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；所述的输送器可实现联动释放操作；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；所述操作手柄包括拉杆、推柄、持柄、释放按键、滑动键和安全按键。本发明适用于微创手术中瓣叶的修复，操作简单方便，且可实现一键释放及修复操作，同时可以降低术中操作难度、强度以及患者痛苦，提高手术成功率。

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，有时由于这些腱索中的一条或多条松弛或破裂，导致瓣膜脱垂，于是正常设置在心房与心室之间的密封受损，导致在心脏收缩过程中血液回流到心房中。
因此，迫切需要一种微创的心脏不停跳的手术方法和装置来完成瓣叶的修复，该过程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。
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；所述的输送器可实现联动释放操作；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；所述修复部件包括锚定件和连接线。
所述操作手柄包括拉杆、推柄、持柄、释放按键、滑动键和安全按键。拉杆与推送管连接，外部套设有推柄；推柄与输送针连接，外部套设有持柄；持柄与外输送管连接；拉杆和推柄都设有弹射机构，可以通过弹簧配合传动；定位鞘套设在外输送管外面，外输送管套设在输送针外面，推送管位于输送针内部用于内载的修复部件释放。
所述拉杆设有排空接口以及可封血可剪断使连接线脱离的管状结构，所述拉杆的外侧与所述推柄的内侧套设有弹簧机构。
所述推柄内侧设有卡键，用于控制所述拉杆的弹射，所述推柄的外侧与所述持柄的内侧套设有弹簧机构。
所述滑动键位于持柄上，触发释放部分藏于推柄中，拉开推柄后可自动滑动到释放位置用于解锁卡键进而释放拉杆。
所述持柄设有按键，触发按键后即可触发推柄弹射，进而滑动键触发卡键，从而触发所述拉杆弹射。
所述持柄设有防止误操作的安全按键，用于防止误操作触发按键。
所述定位鞘在外管夹的配合下实现与外输送管端面平齐，实现术中封血及对植入位置瓣叶的保护。
所述的锚定件由金属或高分子材料组成，用于锚定在瓣叶上。
所述的连接线与锚定件连接，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。
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是本发明提供的操作手柄的立体结构示意图；
图2是本发明提供的操作手柄的剖视图；
图3是本发明提供的输送器非操作手柄部分的结构示意图；
图4是本发明提供的瓣叶修复系统的头端剖视图；
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.触发按键；8.安全按键；9.定位鞘；10.外管夹；11.外输送管；12.输送针；13.推送管；14.修复部件。
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。
本发明的目的在于提供瓣叶修复系统可在心脏不停跳的情况下，通过心尖穿刺进入心室，在超声导航下将修复部件植入到病变的瓣叶区域，将系统撤出后在超声影像下调整连接线的长短，并固定于心室壁上完成瓣叶功能的修复，该系统可降低术中患者的损伤并提高手术成功率。
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行完整、清楚地描述，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做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。
参图1、图2所示，图1是本发明提供的操作手柄的立体结构示意图，图2是本发明提供的操作手柄的剖视图。操作手柄包括：拉杆1、推柄2、持柄3、释放按键7、滑动键6和安全按键8；
拉杆1外部套设有推柄2；推柄2外部套设有持柄3；拉杆1的外侧推柄2的内侧套设有弹簧机构，可以通过弹簧配合传动；推柄2内设有卡键5，卡键5通过弹簧机构来实现限制拉杆1的弹射，推柄2内有可以容纳拉杆1、弹射拉杆1的弹簧机构及供拉杆1滑动的滑槽，推柄2外设有可在持柄3内滑动的滑键。持柄3处设有滑动键6，当拉开推柄2后，滑动键6会自动滑动到触发卡键位置；持柄3设有按键7，当按下按键7后，推柄2会在弹簧机构的作用下向前弹射；持柄3内设有可供推柄2滑动的限位槽，当推柄2在弹簧机构的作用下向前弹射时，滑动键6会触发卡键5，进而实现拉杆1在弹簧机构的作用下向前弹射。持柄3设有安全按键8，用于控制按键7，防止误操作触发按键7。
参图3所示，图3为是本发明提供的输送器非操作手柄部分的结构示意图。输送器非操作手柄部分主要包括包括定位鞘9、外管夹10、外输送管11、输送针12、推送管13，定位鞘9在外管夹10的配合下实现与外输送管11端面平齐，实现术中封血及对植入位置瓣叶的保护。
参图4所示，图4是本发明提供的瓣叶修复系统的头端剖视图。瓣叶修复系包括输送器、修复部件，其中输送器包括操作手柄、定位鞘9、外管夹10、外输送管11、输送针12、推送管13等。修复部件14，包括：锚定件、连接线。
修复部件14的连接线穿过推送管13连接到拉杆1上，锚定件放置在推送管13端部，置于输送针12内部。
拉杆1与推送管13连接，拉杆1的外侧与推柄2的内侧套设有弹簧机构，拉杆1外设有可在持推柄2内滑动的滑键。拉杆1设有排空接口以及可封血可剪断使连接线脱离的管状结构4，剪断管状结构4和修复部件14连接线部分后即可实现修复部件从输送器的脱离。
推柄2内设有卡键5，卡键5通过弹簧机构来实现限制拉杆1的弹射，推柄2内有可以容纳拉杆1、弹射拉杆1的弹簧机构及供拉杆1滑动的滑槽，推柄2外设有可在持柄3内滑动的滑键。
持柄3处设有滑动键6，当拉开推柄2后，滑动键6会自动滑动到触发卡键位置；持柄3设有按键7，当按下按键7后，推柄2会在弹簧机构的作用下向前弹射；持柄3内设有可供推柄2滑动的限位槽，当推柄2在弹簧机构的作用下向前弹射时，滑动键6会触发卡键5，进而实现拉杆1在弹簧机构的作用下向前弹射。
持柄3设有安全按键8，用于控制按键7，防止误操作触发按键7，导致修复部件14的非预期释放。
定位鞘9在外管夹10的配合下实现与外输送管11端面平齐，实现术中封血及对植入位置瓣叶的保护。
需要说明的是，实施例是为了更清晰的表达本发明的意图，并不是限制本发明的实施方案。本发明的核心是保护微创操作手柄及具有该操作手柄的瓣叶修复装置，本发明适用于任何其他需要植入人工缝线的组织。
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 (10)

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，
所述的输送器可实现联动释放操作；
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；
所述修复部件包括锚定件、连接线。
2.如权利要求1所述输送器，其特征在于，所述操作手柄包括：拉杆、推柄、持柄、释放按键、滑动键和安全按键；拉杆与推送管连接，外部套设有推柄；推柄与输送针连接，外部套设有持柄；持柄与外输送管连接；拉杆和推柄都设有弹射机构，可以通过弹簧配合传动；定位鞘套设在外输送管外面，外输送管套设在输送针外面，推送管位于输送针内部用于内载的修复部件释放。
3.如权利要求2所述操作手柄，其特征在于，所述拉杆设有排空接口以及可封血可剪断使连接线脱离的管状结构，所述拉杆的外侧与所述推柄的内侧套设有弹簧机构。
4.如权利要求2所述操作手柄，其特征在于，所述推柄内侧设有卡键，用于控制所述拉杆的弹射，所述推柄的外侧与所述持柄的内侧套设有弹簧机构。
5.如权利要求2所述操作手柄，其特征在于，所述滑动键位于持柄上，触发释放部分藏于推柄中，拉开推柄后可自动滑动到释放位置用于解锁卡键进而释放拉杆。
6.如权利要求2所述操作手柄，其特征在于，所述持柄设有按键，触发按键后即可触发推柄弹射，进而滑动键触发卡键，从而触发所述拉杆弹射。
7.如权利要求2所述操作手柄，其特征在于，所述持柄设有防止误操作的安全按键，用于防止误操作触发按键。
8.如权利要求2所述定位鞘，其特征在于，所述定位鞘在外管夹的配合下实现与外输送管端面平齐，实现术中封血及对植入位置瓣叶的保护。
9.如权利要求1所述的修复部件，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。
10.根据权利要求1所述的修复部件，其特征在于，所述连接线与锚定件连接，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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