WO2019076325A1 - 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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Publication number
WO2019076325A1
WO2019076325A1 PCT/CN2018/110684 CN2018110684W WO2019076325A1 WO 2019076325 A1 WO2019076325 A1 WO 2019076325A1 CN 2018110684 W CN2018110684 W CN 2018110684W WO 2019076325 A1 WO2019076325 A1 WO 2019076325A1
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Prior art keywords
handle
tube
push
minimally invasive
push handle
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PCT/CN2018/110684
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English (en)
French (fr)
Inventor
代高旭
李阳
杨宇霆
周庆亮
可大年
孟坚
Original Assignee
北京迈迪顶峰医疗科技有限公司
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Application filed by 北京迈迪顶峰医疗科技有限公司 filed Critical 北京迈迪顶峰医疗科技有限公司
Priority to JP2020540666A priority Critical patent/JP6971408B2/ja
Priority to KR1020207010194A priority patent/KR102376568B1/ko
Priority to EP18869140.6A priority patent/EP3698759A4/en
Publication of WO2019076325A1 publication Critical patent/WO2019076325A1/zh
Priority to US16/852,006 priority patent/US11678984B2/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/2454Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457Chordae tendineae prostheses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • AHUMAN NECESSITIES
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    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
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    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/2466Delivery devices therefor
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    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
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    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
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    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409Instruments for applying suture anchors
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    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A61B2017/0488Instruments for applying suture clamps, clips or locks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/2454Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/246Devices for obstructing a leak through a native valve in a closed condition
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/2463Implants forming part of the valve leaflets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • 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
    • A61F2220/0008Fixation appliances for connecting prostheses to the body

Definitions

  • the operating handle comprises: a pull rod, a push handle, a handle, a release button, a slide button and a safety button;
  • the pull rod is connected with the push tube, the pull rod is externally provided with a push handle;
  • the push handle is connected with the transport needle, and the push handle is externally sleeved
  • the handle is connected with the outer conveying pipe;
  • the pull rod and the push handle are provided with an ejection mechanism, and the pull rod and the push handle are driven by the spring;
  • the positioning sheath is sleeved outside the outer conveying tube, and the outer conveying tube is sleeved outside the conveying needle,
  • the push tube is located inside the delivery needle, and the push tube is used to release the repairing component inside the delivery needle.
  • the repairing component is connected to the conveyor;
  • the operating handle is provided with three layers of sleeves, which are respectively a pushing tube, a conveying needle and an outer conveying tube from the inside to the outside;
  • the operating handle comprises a pulling rod and a push handle, Holding handle
  • One end of the outer conveying pipe is connected with the third pipe seat; the other end penetrates the center of the outer pipe clamp and the positioning sheath;
  • the first tube holder is provided with a first card slot, and the first tube is disposed on the pushing tube, and the first card slot is matched with the first card structure;
  • the handle has a sliding button and a second sliding slot for sliding the push handle, the second sliding slot is matched with the second sliding key; the sliding key is located at the tail of the handle, and the sliding button can be opened after the pushing handle is opened Slide to the release position, the slide button is used to unlock the card button when the push handle is ejected to trigger the rod ejection.
  • FIG. 2 is a schematic structural view of a non-operating handle portion of a conveyor provided by the present application
  • Figure 6 is an exploded view of the third tube and the outer tube provided by the present application.
  • Figure 8 is a first chute position diagram provided by the present application.
  • FIG. 9 is a second chute position diagram provided by the present application.
  • Figure 10 is a second slide key position diagram provided by the present application.
  • FIG. 1 is a schematic structural view of an operating handle provided by the present application
  • FIG. 3 is a schematic view showing the setting of a repairing component of the leaflet repairing system provided by the present application.
  • the present invention provides a system for minimally invasive surgery for leaflet repair, comprising a conveyor, a repair component 21, and a repair component 21 coupled to the conveyor; wherein the repair component 21 includes an anchor, a connecting line, an anchor and Cable connection.
  • the connecting line of the repairing member 21 is connected to the clip 28 of the tie rod 1 through the push tube 11, and the anchor is placed at the end of the push tube 11 and placed inside the transport needle 10.
  • the anchoring member is composed of metal or high molecular material for anchoring on the leaflets;
  • the connecting line is made of a polymer material, such as expanded polytetrafluoroethylene, polyester and the like.
  • the push handle 2 is provided with a snap key 5, and the snap key 5 realizes the ejection of the limit pull rod 1 by a spring mechanism.
  • the push handle 2 has a first spring mechanism 12 for accommodating the pull rod 1, the ejection pull rod 1, and a sliding for the sliding rod 1
  • the slot and the push handle 2 are provided with a slide key that can slide in the handle 3.
  • the handle 3 is provided with a slide button 6.
  • the pushing tube 11 is located inside the delivery needle 10 for the release of the repairing component
  • the first handle 14 and the second are sequentially arranged in the extending direction from the left to the right (according to the orientation of FIG. 1) in the operating handle.

Abstract

一种用于微创手术进行瓣叶修复的系统,其包括输送器和修复部件(21)。输送器可实现联动释放操作;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)和推送管(11);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)。瓣叶修复系统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
相关申请的交叉引用
本申请要求于2017年10月20日提交中国专利局的申请号为2017109853836、名称为“一种用于微创手术进行瓣叶修复的系统”的中国专利申请以及于2018年5月3日提交中国专利局的申请号为2018104143657、名称为“一种用于微创手术进行瓣叶修复的系统”的中国专利申请的优先权,其全部内容通过引用结合在本申请中。
技术领域
本申请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。
但在当前相关技术中,瓣叶修复手术中的植入操作较难,术者手术强度和难度较大。
发明内容
有鉴于此,本申请提供了一种用于微创手术进行瓣叶修复的系统,可以在心脏不停跳的情况下完成手术,准确修复瓣叶功能的系统。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。
本申请采用的技术方案是:
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,输送器可实现联动释放操作;
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;
修复部件包括锚定件、连接线。
进一步的,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,拉杆外部套设有推柄;推柄与输送针连接,推柄外部套设有持柄;持柄与外输送管连接;拉杆和推柄都设有弹射机构,拉杆和推柄通过弹簧配合传动;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,推送管用于释放输送针内部的修复部件。
进一步的,拉杆设有排空接口以及可封血、可剪断使连接线断开的管状结构,拉杆的外侧与推柄的内侧之间设置有弹簧机构。
进一步的,推柄内侧设有卡键,用于控制拉杆的弹射,推柄的外侧与持柄的内侧之间设置有弹簧机构。
进一步的,滑动键位于持柄上,触发释放部分位于推柄中,拉开推柄能够使滑动键滑动到释放位置用于解锁卡键进而释放拉杆。
进一步的,释放按键设置于持柄,触发释放按键后即可触发推柄弹射,滑动键能够在推柄被弹射后触发卡键,从而触发拉杆弹射。
进一步的,持柄设有防止误操作的安全按键,安全按键用于防止误操作触发释放按键。
进一步的,定位鞘与外管夹配合以使得定位鞘与外输送管的端面平齐,以实现术中封血及对植入位置瓣叶的保护。
进一步的,锚定件由金属或高分子材料组成,锚定件用于锚定在瓣叶上。
进一步的,连接线与锚定件连接,连接线由高分子材料制成。
在本发明的一种实施例中,修复部件与输送器连接;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;操作手柄包括拉杆、推柄、持柄;
推柄套设于拉杆外部,持柄套设于推柄外部;
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;拉杆与第一管座连接,推柄与第二管座连接,持柄与第三管座连接;
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;
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;
外输送管的一端与第三管座连接;另一端贯穿外管夹与定位鞘的中心;
锚定件与连接线连接。
进一步的,第一管座上设有第一卡槽,推送管上设有第一卡片,第一卡槽与第一卡片结构配合;
第二管座上设有第二卡槽,输送针上设有第二卡片,第二卡槽与第二卡片结构配合;
第三管座上设有第三卡槽,外输送管上设有第三卡片,第三卡槽与第三卡片结构配合。
进一步的,拉杆的外侧与推柄的内侧之间设置有第一弹簧机构,拉杆与推柄通过第一弹簧机构传动连接;
推柄的外侧与持柄的内侧之间设置有第二弹簧机构,推柄与持柄通过第二弹簧机构传动连接。
进一步的,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,管状结构可封血以及可被剪断以使连接线断开以使得锚定件脱离输送器;
拉平装置包括线夹和第一弹簧,线夹和连接线连接。
进一步的,推柄内设有供拉杆滑动的第一滑槽,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。
进一步的,推柄设有方形结构,方形结构内设有卡键,卡键的一端设有第二弹簧,卡键在第二弹簧的作用下实现对拉杆的锁定。
进一步的,持柄设有滑动键及供推柄滑动的第二滑槽,第二滑槽与第二滑键相适配;滑动键位于持柄的尾部,推柄拉开后,滑动键可滑动到释放位置,滑动键在推柄弹射时用于解锁卡键进而触发拉杆弹射。
进一步的,持柄的前端设有释放按键,释放按键的下端设有第三弹簧,拉开推柄后,释放按键能够在第三弹簧的作用下将推柄锁定,触发释放按键后即可触发推柄弹射。
进一步的,持柄上还设有安全按键,安全按键与释放按键相邻设置,安全按键尾部设有第四弹簧,安全按键通过第四弹簧的力保持锁定。
进一步的,持柄上还设有安全按键复位孔,安全按键复位孔与安全按键相邻设置,安全按键复位孔用于安全按键解锁后的复位。
与现有技术相对比,本申请产生的有益效果是:
本申请的用于微创手术进行瓣叶修复的系统包括输送器和修复部件,输送器和修复部件可实现联动释放操作;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;修复部件包括锚定件、连接线。本申请提供的系统可以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超声、胸腔镜、腹腔镜的导航功能准确的修复瓣叶功能,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,提高手术成功率。
附图说明
图1是本申请提供的操作手柄的剖视图;
图2是本申请提供的输送器非操作手柄部分的结构示意图;
图3是本申请提供的瓣叶修复系统的修复部件的设置示意图;
图4是本申请提供的第一管座与推送管分解图;
图5是本申请提供的第二管座与输送针分解图;
图6是本申请提供的第三管座与外输送管分解图;
图7是本申请提供的拉平装置和管状结构的配合示意图;
图8是本申请提供的第一滑槽位置图;
图9是本申请提供的第二滑槽位置图;
图10是本申请提供的第二滑键位置图;
图11是本申请提供的操作手柄前端的结构示意图;
图12是本申请提供的操作手柄立体结构图。
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-释放按键;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,对本申请的具体实施方式作详细的说明。
参图1和图3所示,图1为本申请提供的操作手柄结构示意图,图3是本申请提供的瓣叶修复系统的修复部件的设置示意图,。本申请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10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;连接线由高分子材料制成,比如膨体聚四氟乙烯、聚酯等材料。
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;
在本申请实施例中,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的内侧套设有第一弹簧机构12,拉杆1和推杆2可以通过第一弹簧机构12的弹簧配合传动,使得拉杆1相对于推柄2在轴向上运动;推柄2的外侧套设有第二弹簧机构13,推柄2和持柄3可以通过第二弹簧机构13配合传动,使得推柄2相对于持柄3在轴向上运动。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的第一弹簧机构12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设有释放按键7,当按下释放按键7后,推柄2会在第二弹簧机构13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在第二弹簧机构13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在第一弹簧机构12的作用下向前弹射。持柄3设有安全按键8,用于控制释放按键7,防止误操作触发释放按键7。
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(见图2)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;操作手柄内从左自右(以图1方位为准)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。
图4是本申请提供的第一管座与推送管分解图;图5是本申请提供的第二管座与输送针分解图;图6是本申请提供的第三管座与外输送管分解图,请参照图4至图6,进一步的,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。应当理解,在本申请的其他实施例中,推送管11、输送针10以及外输送管9与各自对应 的管座的连接方式也可以不采用卡片和卡槽配合粘接的方式相连,而是通过紧固件连接。
图7是本申请提供的拉平装置和管状结构的配合示意图。请参照图7,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(见图1),管状结构4可封血并且可被剪断使得连接线断开;剪断管状结构4和修复部件21连接线部分后即可实现锚定件从输送器的脱离。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与修复部件21的连接线连接;
图8是本申请提供的第一滑槽位置图;图9是本申请提供的第二滑槽位置图;图10是本申请提供的第二滑键位置图。请参照图8至图10,进一步的,第一弹簧机构12用于弹射拉杆1,推柄2内还设有供拉杆1滑动的第一滑槽30,第一滑槽30与拉杆1上的第一滑键18相适配;持柄3内设有供推柄2滑动的第二滑槽31,第二滑键32与持柄3上的第二滑槽31相适配。
图11是本申请提供的操作手柄前端的结构示意图;图12是本申请提供的操作手柄立体结构图。请参照图11和图12,推柄2左侧设有方形结构,卡键5设置于方形结构内,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(图未示),卡键5在第二弹簧的作用下实现对所述拉杆1的锁定。
释放按键7位于持柄3的前端(即图1所示的右端),通过持柄3前端内部的滑槽实现上下运动,释放按键7的下端设有第三弹簧(图未示),释放按键7在第三弹簧力的作用下保持对推柄2的锁定。
在本申请的实施例中,持柄3设有供推柄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(即图1所示的左端),滑动键6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,拉杆1在第一弹簧组件12的作用下实现向前弹射。
持柄3上还设有安全按键复位孔33,在本申请的一种实施例中,安全按键8与释放按键7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用于防止释放按键7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。
在本申请实施例中,定位鞘19可以与外管夹20配合使用,使定位鞘19的端面与外输送管9的端面平齐,以实现术中封血及对植入位置瓣叶的保护。
本申请实施例提供的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。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超声、胸腔镜、腹腔镜的导航功能准确的修复瓣叶功能。并且本 申请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。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。本申请实施例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。
以上所述的一系列的详细说明仅仅是针对本申请的可行性实施方式的具体说明,它们并不是用以限制本申请的保护范围,在所述技术领域普通技术人员所具备的知识范围内,在不脱离本申请宗旨的前提下作出的各种变化均属于本申请的保护范围。
工业实用性
本申请的瓣叶修复系统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。

Claims (20)

  1. 一种用于微创手术进行瓣叶修复的系统,包括:输送器和修复部件,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、输送针和推送管;
    所述修复部件包括锚定件和连接线。
  2. 根据权利要求1所述的用于微创手术进行瓣叶修复的系统,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;所述拉杆与所述推送管连接,所述拉杆外部套设有所述推柄;所述推柄与所述输送针连接,所述推柄外部套设有所述持柄;所述持柄与所述外输送管连接;所述拉杆和所述推柄都设有弹射机构,所述拉杆和所述推柄通过弹簧配合传动;所述定位鞘套设在所述外输送管外面,所述外输送管套设在所述输送针外面,所述推送管位于所述输送针内部,所述推送管配置成释放所述输送针内部的所述修复部件。
  3. 根据权利要求2所述的用于微创手术进行瓣叶修复的系统,其特征在于,所述拉杆设有排空接口以及可封血、可剪断使所述连接线断开的管状结构,所述拉杆的外侧与所述推柄的内侧之间设置有弹簧机构。
  4. 根据权利要求2所述的用于微创手术进行瓣叶修复的系统,其特征在于,所述推柄内侧设有卡键,配置成控制所述拉杆的弹射,所述推柄的外侧与所述持柄的内侧之间设置有弹簧机构。
  5. 根据权利要求4所述的用于微创手术进行瓣叶修复的系统,其特征在于,所述滑动键位于所述持柄上,触发释放部分位于所述推柄中,拉开所述推柄能够令所述滑动键滑动到释放位置用于解锁所述卡键进而释放拉杆。
  6. 根据权利要求4所述的用于微创手术进行瓣叶修复的系统,其特征在于,所述释放按键设置于所述持柄,触发所述释放按键后即可触发推柄弹射,所述滑动键能够在所述推柄被弹射后触发所述卡键,从而触发所述拉杆弹射。
  7. 根据权利要求2所述的用于微创手术进行瓣叶修复的系统,其特征在于,所述持柄设有防止误操作的安全按键,所述安全按键配置成防止误操作触发所述释放按键。
  8. 根据权利要求2所述的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以使得所述定位鞘与所述外输送管的端面平齐,以实现术中封血及对 植入位置瓣叶的保护。
  9. 根据权利要求1-8中任一项所述的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,所述锚定件被配置成锚定在瓣叶上。
  10. 根据权利要求1-8中任一项所述的用于微创手术进行瓣叶修复的系统,其特征在于,所述连接线与所述锚定件连接,所述连接线由高分子材料制成。
  11. 根据权利要求1所述的用于微创手术进行瓣叶修复的系统,其特征在于,所述修复部件与所述输送器连接;所述操作手柄内设有三层套管,由内至外分别为推送管、输送针和外输送管;所述操作手柄包括拉杆、推柄和持柄;
    所述推柄套设于所述拉杆外部,所述持柄套设于所述推柄外部;
    所述操作手柄内从左自右延长方向上依次设有第一管座、第二管座和第三管座;所述拉杆与所述第一管座连接,所述推柄与所述第二管座连接,所述持柄与所述第三管座连接;
    所述推送管的一端与所述第一管座连接,另一端贯穿所述第二管座的中心;
    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;
    所述锚定件与所述连接线连接。
  12. 根据权利要求11所述的用于微创手术进行瓣叶修复的系统,其特征在于,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,所述第二卡槽与所述第二卡片结构配合;
    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,所述第三卡槽与所述第三卡片结构配合。
  13. 根据权利要求11所述的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之间设置有第一弹簧机构,所述拉杆与所述推柄通过所述第一弹簧机构传动连接;
    所述推柄的外侧与所述持柄的内侧之间设置有第二弹簧机构,所述推柄与所述持柄通过所述第二弹簧机构传动连接。
  14. 根据权利要求11所述的用于微创手术进行瓣叶修复的系统,其特征在于,所述拉杆上设有排空接口、拉平装置、管状结构以及可在所述推柄内滑动的第一滑键,所述管状结构可封血以及可被剪断以使所述连接线断开以使得所述锚定件脱离所述输送器;
    所述拉平装置包括线夹和第一弹簧,所述线夹和所述连接线连接。
  15. 根据权利要求14所述的用于微创手术进行瓣叶修复的系统,其特征在于,所述推柄内设有供所述拉杆滑动的第一滑槽,所述第一滑槽与所述第一滑键相适配;所述推柄外设有可在所述持柄内滑动的第二滑键。
  16. 根据权利要求15所述的用于微创手术进行瓣叶修复的系统,其特征在于,所述推柄设有方形结构,所述方形结构内设有卡键,所述卡键的一端设有第二弹簧,所述卡键在所述第二弹簧的作用下实现对所述拉杆的锁定。
  17. 如权利要求16所述的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;所述滑动键位于所述持柄的尾部,所述推柄拉开后,所述滑动键可滑动到释放位置,所述滑动键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。
  18. 根据权利要求11所述的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释放按键,所述释放按键的下端设有第三弹簧,拉开所述推柄后,所述释放按键能够在第三弹簧的作用下将所述推柄锁定,触发所述释放按键后即可触发所述推柄弹射。
  19. 根据权利要求18所述的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,所述安全按键与所述释放按键相邻设置,所述安全按键尾部设有第四弹簧,所述安全按键通过第四弹簧的力保持锁定。
  20. 根据权利要求19所述的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复位孔,所述安全按键复位孔与所述安全按键相邻设置,所述安全按键复位孔用于安全按键解锁后的复位。
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