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CN109984869A - Heart valve prosthesis conveying device - Google Patents

Heart valve prosthesis conveying device Download PDF

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Publication number
CN109984869A
CN109984869A CN201711487976.6A CN201711487976A CN109984869A CN 109984869 A CN109984869 A CN 109984869A CN 201711487976 A CN201711487976 A CN 201711487976A CN 109984869 A CN109984869 A CN 109984869A
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China
Prior art keywords
catheter
conveying device
conduit
medical instrument
distal end
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Granted
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CN201711487976.6A
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CN109984869B (en
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江巍
谢惠雄
王刚
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Shenzhen Jianxin Medical Technology Co ltd
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Lifetech Scientific Shenzhen Co Ltd
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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
    • 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

本发明公开了一种医疗器械输送装置,包括中空外鞘导管和与所述外鞘导管相连的第一制动单元,所述第一制动单元包括中空管状的第一旋转件,以及收容于所述第一旋转件的内腔内的固定件,所述固定件与所述外鞘导管相连;所述第一旋转件内壁设有绕所述第一旋转件的轴向呈螺旋状的导向槽,所述固定件的侧壁上设有收容凹槽;所述医疗器械输送装置还包括夹设于所述导向槽与收容凹槽之间的滚动件,所述第一旋转件旋转时带动所述滚动件在所述导向槽内滚动,同时带动所述固定件和所述外鞘导管相对所述第一旋转件轴向运动。本发明的医疗器械输送装置的第一制动单元将自身的周向转动转换成外鞘导管的轴向移动,使得医疗器械的植入更加方便省力。

The invention discloses a medical device delivery device, comprising a hollow outer sheath conduit and a first braking unit connected with the outer sheath conduit, the first braking unit comprising a hollow tubular first rotating member, and a first braking unit accommodated in a A fixing piece in the inner cavity of the first rotating piece, the fixing piece is connected with the outer sheath catheter; the inner wall of the first rotating piece is provided with a helical guide around the axial direction of the first rotating piece A receiving groove is formed on the side wall of the fixing member; the medical device conveying device further includes a rolling member sandwiched between the guiding groove and the receiving groove, and the first rotating member drives the rotation of the first rotating member. The rolling member rolls in the guide groove, and simultaneously drives the fixed member and the outer sheath catheter to move axially relative to the first rotating member. The first braking unit of the medical device delivery device of the present invention converts the circumferential rotation of itself into the axial movement of the outer sheath catheter, so that the implantation of the medical device is more convenient and labor-saving.

Description

心脏瓣膜假体输送装置Heart valve prosthesis delivery device

技术领域technical field

本发明涉及介入医疗器械领域,具体涉及一种心脏瓣膜假体输送装置。The invention relates to the field of interventional medical devices, in particular to a heart valve prosthesis delivery device.

背景技术Background technique

人体的心脏分为四个腔室,每个腔室都有各自的“出口”,共有四个瓣膜(二尖瓣、主动脉瓣、肺动脉瓣和三尖瓣),它们确保由心脏泵送的血液在心血管系统中按照指定的方向流过。二尖瓣位于左心房和左心室之间,正常的二尖瓣保证血液循环由左心房一定向左心室方向流动和通过一定的血流量。另外当左心室收缩时,二尖瓣的两片柔性小叶闭合,可防止血液从心脏的左心室向左心房回流。各种心脏疾病或退行性病变均可能导致二尖瓣功能障碍,使得二尖瓣变得异常缩窄或扩张,或者允许血液从左心室返流回左心房中。二尖瓣功能的缺失损伤,会影响心脏的正常工作,致使人逐渐衰弱或危及生命。The human heart is divided into four chambers, each with its own "outlet", and a total of four valves (the mitral, aortic, pulmonary, and tricuspid valves) that ensure the Blood flows in a designated direction in the cardiovascular system. The mitral valve is located between the left atrium and the left ventricle. The normal mitral valve ensures that the blood circulation flows from the left atrium to the left ventricle and through a certain blood flow. In addition, when the left ventricle contracts, the two flexible leaflets of the mitral valve close, preventing the backflow of blood from the left ventricle of the heart to the left atrium. Various heart diseases or degenerative diseases can cause mitral valve dysfunction, causing the mitral valve to become abnormally narrowed or dilated, or to allow blood to flow back from the left ventricle into the left atrium. The loss of mitral valve function can affect the normal work of the heart, causing people to gradually become debilitating or life-threatening.

针对二尖瓣功能的障碍,存在多种治疗的方法,如传统的瓣膜置换手术,被认为是“开放心脏”手术。简而言之,手术需要手术打开胸部,用心肺机启动体外循环,打开心脏,切除和更换患者的二尖瓣,但由于体外循坏的操作复杂和老年患者的耐受性差,“开放心脏”手术存在较高死亡风险。目前,通过介入的手段进行二尖瓣功能障碍的治疗方法逐渐被人们所关注,且已开发出用于递送置换二尖瓣的创伤较小的经导管技术。在此类技术中,自彭式假体瓣膜一般以卷曲状态安装在柔性导管的末端并经患者的血管或身体推进,直至该假体瓣膜抵达植入部位。继而假体瓣膜在有缺陷的天然二尖瓣膜的部位处扩张至其功能尺寸。Various treatments exist for dysfunction of the mitral valve, such as traditional valve replacement surgery, which is considered an "open heart" surgery. In short, the operation requires surgery to open the chest, start cardiopulmonary bypass with a heart-lung machine, open the heart, and remove and replace the patient's mitral valve. Surgery carries a high risk of death. Currently, there is growing interest in the treatment of mitral valve dysfunction by interventional means, and less invasive transcatheter techniques have been developed for delivering a replacement mitral valve. In such techniques, a self-expanding prosthetic valve is typically mounted on the tip of a flexible catheter in a crimped state and advanced through the patient's blood vessel or body until the prosthetic valve reaches the implantation site. The prosthetic valve is then expanded to its functional size at the site of the defective native mitral valve.

虽然经导管介入技术置换天然二尖瓣膜是治疗功能不全的有效方法,但假体瓣膜的体积往往较大,在输送装置中递送存在较大难度;若增大输送导管的尺寸,对患者心脏的损伤也会相应增加。此外现有系统和方法的置换过程系统操控复杂,较容易损伤心脏组织从而导致治疗效果不佳。因此,期望提供用于治疗瓣膜功能不全,比如治疗二尖瓣功能不全的改进的装置和方法,需要一个合适的假体瓣膜的递送装置,输送假体瓣膜到达目标位置和释放,要求输送器的操作简单,假体瓣膜的释放力小,便于医生的操作。Although transcatheter interventional technology to replace the natural mitral valve is an effective method for the treatment of insufficiency, the volume of the prosthetic valve is often large, and it is difficult to deliver it in the delivery device; if the size of the delivery catheter is increased, the patient's heart will be affected. Damage will increase accordingly. In addition, the replacement process of the existing systems and methods is complicated to control, and it is easy to damage the heart tissue, resulting in poor treatment effect. Accordingly, it would be desirable to provide improved devices and methods for treating valvular insufficiency, such as mitral valve insufficiency, a need for a suitable prosthetic valve delivery device, delivery of the prosthetic valve to a target location and release, requiring the delivery of The operation is simple, the release force of the prosthetic valve is small, and the operation of the doctor is convenient.

发明内容SUMMARY OF THE INVENTION

本发明提供了一种医疗器械输送装置,包括中空外鞘导管和与所述外鞘导管相连的第一制动单元,所述第一制动单元包括中空管状的第一旋转件,以及收容于所述第一旋转件的内腔内的固定件,所述固定件与所述外鞘导管相连;所述第一旋转件内壁设有绕所述第一旋转件的轴向呈螺旋状的导向槽,所述固定件的侧壁上设有收容凹槽;所述医疗器械输送装置还包括夹设于所述导向槽与收容凹槽之间的滚动件,所述第一旋转件旋转时带动所述滚动件在所述导向槽内滚动,同时带动所述固定件和所述外鞘导管相对所述第一旋转件轴向运动。The present invention provides a medical device delivery device, comprising a hollow outer sheath conduit and a first braking unit connected with the outer sheath conduit, the first braking unit comprising a hollow tubular first rotating member, and a first braking unit accommodated in a A fixing piece in the inner cavity of the first rotating piece, the fixing piece is connected with the outer sheath catheter; the inner wall of the first rotating piece is provided with a helical guide around the axial direction of the first rotating piece A receiving groove is formed on the side wall of the fixing member; the medical device conveying device further includes a rolling member sandwiched between the guiding groove and the receiving groove, and the first rotating member drives the rotation of the first rotating member. The rolling member rolls in the guide groove, and simultaneously drives the fixed member and the outer sheath catheter to move axially relative to the first rotating member.

在一实施例中,所述第一制动单元还包括导向件,所述导向件设于所述第一旋转体与所述固定件之间,所述导向件具有内腔和侧壁,所述侧壁上设有与所述导向件的内腔相通的轴向限位开口,所述限位开口限定所述固定件轴向移动的路径。In an embodiment, the first braking unit further includes a guide member, the guide member is arranged between the first rotating body and the fixed member, the guide member has an inner cavity and a side wall, so An axial limit opening communicated with the inner cavity of the guide member is provided on the side wall, and the limit opening defines a path for the axial movement of the fixing member.

在一实施例中,所述输送装置还包括手柄壳体,所述第一旋转件部分设于所述手柄壳体内,所述手柄壳体限定所述第一旋转件相对于所述手柄壳体仅发生周向转动。In one embodiment, the delivery device further includes a handle housing, the first rotating member is partially disposed in the handle housing, and the handle housing defines the relative relation of the first rotating member to the handle housing. Only circumferential rotation occurs.

在一实施例中,所述滚动件为球形结构。In one embodiment, the rolling element is a spherical structure.

在一实施例中,所述滚动件的数量至少为1个。In one embodiment, the number of the rolling elements is at least one.

在一实施例中,所述导向槽的螺旋角度范围为15~45度。In one embodiment, the helix angle of the guide groove ranges from 15 to 45 degrees.

在一实施例中,所述固定件包括第一接头主体,所述第一接头主体与所述外鞘导管相连,所述滚动件设于所述第一接头主体侧壁与所述第一旋转件的内壁之间。In one embodiment, the fixing member includes a first joint body, the first joint body is connected with the outer sheath catheter, and the rolling member is provided on the side wall of the first joint body and the first rotating member. between the inner walls of the piece.

在一实施例中,所述固定件还包括调节件和设于所述调节件远端的第一密封圈,所述调节件上设有外螺纹,所述第一接头主体近端还设有收容调节件和第一密封圈的近端开口,所述第一接头主体的近端开口内设有与所述调节件上外螺纹配合的内螺纹。In one embodiment, the fixing member further includes an adjusting member and a first sealing ring disposed at the distal end of the adjusting member, the adjusting member is provided with an external thread, and the proximal end of the first joint body is also provided with an external thread. The proximal end opening of the adjusting piece and the first sealing ring is accommodated, and the proximal end opening of the first joint body is provided with an internal thread matched with the external thread on the adjusting piece.

在一实施例中,所述输送装置还包括连接导管,所述连接导管贯穿所述外鞘导管。In one embodiment, the delivery device further includes a connecting conduit extending through the outer sheath conduit.

在一实施例中,所述连接导管远端设有螺纹结构,所述连接导管通过所述螺纹结构与医疗器械连接。In one embodiment, the distal end of the connecting conduit is provided with a threaded structure, and the connecting conduit is connected with the medical device through the threaded structure.

本发明的医疗器械输送装置至少具有以下有益效果,通过制动组件实现对导管组件的控制,尤其是第一制动单元将自身的周向转动转换成外鞘导管的轴向移动,使得医疗器械的植入更加方便省力。The medical device delivery device of the present invention has at least the following beneficial effects: the control of the catheter assembly is realized by the braking assembly, especially the first braking unit converts its circumferential rotation into the axial movement of the sheath catheter, so that the medical device The implantation is more convenient and labor-saving.

附图说明Description of drawings

图1为本发明实施例的医疗器械输送装置结构示意图;1 is a schematic structural diagram of a medical device delivery device according to an embodiment of the present invention;

图2为本发明实施例的医疗器械输送装置截面结构示意图;2 is a schematic cross-sectional structural diagram of a medical device delivery device according to an embodiment of the present invention;

图3为本发明实施例的医疗器械输送装置部分拆分结构示意图;3 is a schematic diagram of a partially disassembled structure of a medical device delivery device according to an embodiment of the present invention;

图4为本发明实施例的医疗器械输送装置的第一旋转件结构示意图;图5为图4所示第一旋转件的截面结构示意图;4 is a schematic structural diagram of a first rotating member of a medical device delivery device according to an embodiment of the present invention; FIG. 5 is a cross-sectional structural schematic diagram of the first rotating member shown in FIG. 4 ;

图6为本发明实施例的医疗器械输送装置的导向件结构示意图;6 is a schematic structural diagram of a guide member of a medical device delivery device according to an embodiment of the present invention;

图7a为本发明实施例的医疗器械输送装置第一制动单元截面结构示意图;7a is a schematic cross-sectional structural diagram of a first braking unit of a medical device delivery device according to an embodiment of the present invention;

图7b为图7a部分结构放大图;Fig. 7b is an enlarged view of a part of the structure of Fig. 7a;

图8为本发明实施例的医疗器械输送装置第二制动单元和第三制动单元结构示意图;8 is a schematic structural diagram of the second braking unit and the third braking unit of the medical device delivery device according to the embodiment of the present invention;

图9为图8所示结构的截面结构示意图;9 is a schematic cross-sectional structure diagram of the structure shown in FIG. 8;

图10a至图10g为利用本发明的输送装置进行人工心脏瓣膜植入的操作过程示意图。10a to 10g are schematic diagrams illustrating the operation process of implanting a prosthetic heart valve using the delivery device of the present invention.

具体实施方式Detailed ways

为更好地理解本发明的技术方案和有益效果,以下结合具体实施例对本发明做进一步的详细说明。在介入医疗领域,定义距离器械操作者近的一端为“近端”,距离器械操作者远的一端为“远端”;定义平行于器械近端中心与远端中心连线的方向为“轴向”,垂直该“轴向”的方向为“径向”,环绕该“轴向”的方向为“周向”。“连接”可以是两物件直接相连接,也可以是通过其它的物件实现连接。In order to better understand the technical solutions and beneficial effects of the present invention, the present invention will be further described in detail below with reference to specific embodiments. In the field of interventional medicine, the end close to the device operator is defined as the "proximal end", and the end farther from the device operator is defined as the "distal end"; the direction parallel to the line connecting the proximal center and the distal center of the device is defined as the "axis" The direction perpendicular to the "axial" is "radial", and the direction around the "axial" is "circumferential". The "connection" can be the direct connection of two objects, or the connection through other objects.

本发明的医疗器械输送装置可用于多种医疗器械的输送,如滤器、封堵器或人工心脏瓣膜等,具体选用时选择合适的导管组件的外径尺寸的输送装置即可。下面以输送人工心脏瓣膜为例对本发明的输送装置做详细说明。The medical device delivery device of the present invention can be used for delivery of various medical devices, such as filters, occluders or artificial heart valves. Hereinafter, the delivery device of the present invention will be described in detail by taking delivery of an artificial heart valve as an example.

参见图1至图3,本发明的医疗器械输送装置01包括制动组件10和中空的导管组件20。导管组件20的近端与制动单元10的远端相连,制动组件10可制动导管组件20。Referring to FIGS. 1 to 3 , the medical device delivery device 01 of the present invention includes a brake assembly 10 and a hollow conduit assembly 20 . The proximal end of the catheter assembly 20 is connected to the distal end of the braking unit 10 , and the braking assembly 10 can brake the catheter assembly 20 .

制动组件10包括由远端至近端轴向依次设置的第一制动单元11、第二制动单元12和第三制动单元13。导管组件20包括同轴设置的外鞘导管21、推杆导管22和连接导管23。外鞘导管21、推杆导管22和连接导管23中的每一个导管均为中空结构且两端具有开口。其中,推杆导管22贯穿外鞘导管21,连接导管23贯穿推杆导管22,连接导管23的内腔可供导丝穿过。推杆导管22与连接导管23以及推杆导管22与外鞘导管21之间均存在间隙,方便导管之间相对运动。外鞘导管21的近端与第一制动单元11连接,第一制动单元11制动外鞘导管21产生轴向运动。第二制动单元12与连接导管23近端连接,以制动连接导管23产生周向转动。第三制动单元13与连接导管23近端端面相抵,以制动连接导管23产生轴向运动。同时,连接导管23远端还设有螺纹结构(图未标),连接导管23能通过该螺纹结构实现与人工心脏瓣膜的连接或解脱。The braking assembly 10 includes a first braking unit 11 , a second braking unit 12 and a third braking unit 13 axially arranged in sequence from the distal end to the proximal end. The catheter assembly 20 includes an outer sheath catheter 21 , a push rod catheter 22 and a connecting catheter 23 that are coaxially arranged. Each of the sheath conduit 21 , the push rod conduit 22 and the connecting conduit 23 is a hollow structure and has openings at both ends. The push rod catheter 22 penetrates the outer sheath catheter 21 , the connecting catheter 23 penetrates the push rod catheter 22 , and the inner cavity of the connecting catheter 23 can be passed through by the guide wire. There are gaps between the push rod conduit 22 and the connecting conduit 23 and between the push rod conduit 22 and the outer sheath conduit 21 to facilitate relative movement between the conduits. The proximal end of the outer sheath catheter 21 is connected to the first braking unit 11 , and the first braking unit 11 brakes the outer sheath catheter 21 to generate axial movement. The second braking unit 12 is connected with the proximal end of the connecting conduit 23 to brake the connecting conduit 23 to generate circumferential rotation. The third braking unit 13 abuts against the proximal end face of the connecting conduit 23 to brake the connecting conduit 23 to generate axial movement. At the same time, the distal end of the connecting catheter 23 is also provided with a threaded structure (not marked in the figure), through which the connecting catheter 23 can be connected or disengaged with the artificial heart valve.

外鞘导管21提供足够的支撑力用于人工心脏瓣膜的输送,其材料可以为单层高分子材料、金属或高分子材料与金属的复合材料,如可选为PEEK、PC、POM、钛或PTFE+不锈钢+PEBAX/尼龙的复合材料等。推杆导管22用于为装载至输送装置01上的人工心脏瓣膜的近端提供轴向的支撑力以及释放心脏瓣膜时的轴向推力,材料可为单层高分子材料,如可选为PE、PC、PEBAX或尼龙等。连接导管23用于连接人工心脏瓣膜,材料可为高分子材料或金属,如可选为PEEK、不锈钢、镍钛或钛等。The outer sheath catheter 21 provides sufficient support for the delivery of the artificial heart valve, and its material can be a single-layer polymer material, metal or a composite material of polymer material and metal, such as PEEK, PC, POM, titanium or PTFE+stainless steel+PEBAX/nylon composite material, etc. The push rod catheter 22 is used to provide an axial support force for the proximal end of the artificial heart valve loaded on the delivery device 01 and an axial thrust force when the heart valve is released. The material can be a single-layer polymer material, such as PE. , PC, PEBAX or nylon, etc. The connecting catheter 23 is used to connect the artificial heart valve, and the material can be polymer material or metal, such as PEEK, stainless steel, nickel titanium or titanium and so on.

外鞘导管21的远端还设有显影环211,显影环211可以在影像设备下成像,指示输送装置01在体内的输送位置。显影环211的材料可以为铂、钽或钨等具有较好显影特性的金属材料。The distal end of the outer sheath catheter 21 is further provided with a developing ring 211, and the developing ring 211 can be imaged under an imaging device to indicate the delivery position of the delivery device 01 in the body. The material of the developing ring 211 may be platinum, tantalum or tungsten and other metal materials with good developing properties.

输送装置01还包括手柄壳体50。手柄壳体50包括可拆解的远端手柄壳体51和近端手柄壳体52。远端手柄壳体51包括远端第一半壳511和远端第二半壳512。远端第一半壳511和远端第二半壳512之间可以通过卡扣连接组装成远端手柄壳体51,也可以通过螺丝和螺母连接、粘接或焊接等方式组装成远端手柄壳体51。近端手柄壳体52包括近端第一半壳521和近端第二半壳522。近端第一半壳521和近端第二半壳522之间可以通过卡扣连接组装成近端手柄壳体52,也可以通过螺丝和螺母连接、粘接或焊接等方式组装成近端手柄壳体52。手柄壳体50用于提供收容和固定作用,将制动组件10收容组装并固定。第一制动单元11、第二制动单元12和第三制动单元13在手柄壳体50内轴向排列设置。其中,第一制动单元11和第二制动单元12均设于手柄壳体50的中部,第三制动单元13靠近手柄壳体50的近端。手柄壳体50上还设有第一阀31和第二阀32,第一阀31和第二阀32均优选为鲁尔接头。其中第一阀31与注射器连接后可对推杆导管22内腔进行冲洗,从推杆导管22远端流出的冲洗液可对外鞘导管21远端进行局部冲洗,第二阀32与注射器连接后可对连接导管23的内腔进行冲洗。The delivery device 01 also includes a handle housing 50 . The handle housing 50 includes a detachable distal handle housing 51 and a proximal handle housing 52 . The distal handle housing 51 includes a distal first half-shell 511 and a distal second half-shell 512 . The distal first half-shell 511 and the distal second half-shell 512 can be assembled into a distal handle housing 51 through snap connection, or can be assembled into a distal handle through screw and nut connection, bonding or welding, etc. housing 51 . The proximal handle housing 52 includes a proximal first half-shell 521 and a proximal second half-shell 522 . The proximal first half-shell 521 and the proximal second half-shell 522 can be assembled into the proximal handle housing 52 through snap connection, or can be assembled into the proximal handle through screw and nut connection, bonding or welding, etc. housing 52 . The handle housing 50 is used for accommodating and fixing, accommodating, assembling and fixing the brake assembly 10 . The first braking unit 11 , the second braking unit 12 and the third braking unit 13 are axially arranged in the handle housing 50 . The first braking unit 11 and the second braking unit 12 are both arranged in the middle of the handle housing 50 , and the third braking unit 13 is close to the proximal end of the handle housing 50 . The handle housing 50 is also provided with a first valve 31 and a second valve 32, and both the first valve 31 and the second valve 32 are preferably Luer connectors. After the first valve 31 is connected with the syringe, the inner cavity of the push rod catheter 22 can be flushed, and the flushing fluid flowing out from the distal end of the push rod catheter 22 can locally flush the distal end of the sheath catheter 21. After the second valve 32 is connected with the syringe The lumen of the connecting catheter 23 can be flushed.

同时参见图4至图7,第一制动单元11包括第一旋转件111、导向件112和固定件113。其中,第一旋转件111为具有中空内腔和内壁的管状结构,包括相连且可同时旋转的近端旋转部111a和远端旋转部111b。其中,近端旋转部111a设于远端手柄壳体51和近端手柄壳体52之间,远端旋转部111b设于远端手柄壳体51内,即操作者可以操作近端旋转部111a旋转,从而带动远端旋转部111b旋转。第一旋转件111的内壁上还设有导向槽111c。导向槽111c为螺旋状,环绕第一旋转件111的轴向旋转设置,螺旋角度的范围可为15~45°,本实施例优选为18°。导向件112设于第一旋转件111的内腔内,且具有内腔和侧壁112a。侧壁112a上还设有与导向件112的内腔相通的轴向的限位开口112b。导向件112的近端可在手柄壳体50内固定,保证第一制动单元11制动外鞘导管21时,导向件112相对第一旋转件111无轴向移动。固定件113部分设于导向件112的内腔内且可相对导向件112轴向移动。固定件113包括第一接头主体113a。第一接头主体113a近端卡设于限位开口112b内,从而保证固定件113相对于导向件112仅发生轴向移动而不产生周向转动。第一接头主体113a的远端设有可收容外鞘导管21近端的远端开口,在本实施例中,第一接头主体113a远端的开口与外鞘导管21的近端通过螺纹连接。可以理解的是,在其它实施例中,第一接头主体与外鞘导管的近端还可以通过卡接、粘接或焊接等其它方式连接。Referring to FIGS. 4 to 7 at the same time, the first braking unit 11 includes a first rotating member 111 , a guiding member 112 and a fixing member 113 . The first rotating member 111 is a tubular structure with a hollow lumen and an inner wall, and includes a proximal rotating portion 111a and a distal rotating portion 111b that are connected and rotatable at the same time. The proximal rotating part 111a is arranged between the distal handle housing 51 and the proximal handle housing 52, and the distal rotating part 111b is arranged in the distal handle housing 51, that is, the operator can operate the proximal rotating part 111a rotate, thereby driving the distal rotating part 111b to rotate. A guide groove 111c is also provided on the inner wall of the first rotating member 111 . The guide groove 111c is helical, and is arranged to rotate around the axial direction of the first rotating member 111. The helical angle can range from 15° to 45°, and is preferably 18° in this embodiment. The guide member 112 is arranged in the inner cavity of the first rotating member 111 and has an inner cavity and a side wall 112a. The side wall 112a is also provided with an axial limit opening 112b which communicates with the inner cavity of the guide member 112 . The proximal end of the guide member 112 can be fixed in the handle housing 50 to ensure that when the first braking unit 11 brakes the sheath catheter 21 , the guide member 112 has no axial movement relative to the first rotating member 111 . The fixing member 113 is partially disposed in the inner cavity of the guide member 112 and can move axially relative to the guide member 112 . The fixing member 113 includes a first joint body 113a. The proximal end of the first joint body 113a is clamped in the limiting opening 112b, so as to ensure that the fixing member 113 only moves in the axial direction relative to the guide member 112 and does not rotate in the circumferential direction. The distal end of the first joint body 113a is provided with a distal opening that can receive the proximal end of the sheath catheter 21 . It can be understood that, in other embodiments, the first joint body and the proximal end of the outer sheath catheter may also be connected by other means such as snap connection, bonding or welding.

进一步地,固定件113还包括调节件113b和设于调节件113b远端的第一密封圈40a。第一接头主体113a近端还设有收容调节件113b和第一密封圈40a的近端开口,该第一接头主体113a的近端开口与远端开口连通,推杆导管22通过该第一接头主体113a的近端开口和远端开口贯穿第一接头主体113a的内部。调节件113b上设有外螺纹,第一接头主体113a的近端开口内设有与调节件113b上外螺纹配合的内螺纹。在装配输送装置01的导管组件20以及制动组件10时,通过调节调节件113b可挤压第一密封圈40a变形,实现密封外鞘导管21和推杆导管22之间间隙的目的。Further, the fixing member 113 further includes an adjusting member 113b and a first sealing ring 40a disposed at the distal end of the adjusting member 113b. The proximal end of the first joint body 113a is also provided with a proximal end opening for accommodating the adjusting member 113b and the first sealing ring 40a, the proximal end opening of the first joint body 113a communicates with the distal opening, and the push rod catheter 22 passes through the first joint The proximal end opening and the distal end opening of the main body 113a penetrate through the interior of the first joint main body 113a. The adjusting member 113b is provided with an external thread, and the proximal opening of the first joint body 113a is provided with an internal thread matching with the external thread on the adjusting member 113b. When assembling the catheter assembly 20 and the braking assembly 10 of the delivery device 01 , the first sealing ring 40 a can be deformed by adjusting the adjusting member 113 b to seal the gap between the sheath catheter 21 and the push rod catheter 22 .

第一接头主体113a的近端外侧还设有半球形收容凹槽113c,收容凹槽113c内设有滚动件114。滚动件114具体设于第一接头主体113a与第一旋转件111的内壁上的导向槽111c之间。滚动件114为球形,直径与导向槽111c的宽度匹配,从而限制滚动件114在导向槽113c内滚动但不会从收容凹槽113c内脱落。滚动件114的数量至少为1个,本实施例优选为2个且对称设置,同时导向槽111c的数量不少于滚动件114的数量,本实施例导向槽111c的数量亦为2个。可以理解是,其它实施例中,收容凹槽还可以为四分之一球形凹槽、三分之一球形凹槽、五分之一球形凹槽等。其中,四分之一球形凹槽指的是,在中空的球形结构的四分之一直径处,沿垂直于该直径的方向切割该球形结构后获得的与四分之一直径对应的凹槽。三分之一球形凹槽、五分之一球形凹槽与四分之一球形凹槽定义方法类似,在此不再赘述。The outer side of the proximal end of the first joint main body 113a is further provided with a hemispherical receiving groove 113c, and a rolling element 114 is arranged in the receiving groove 113c. The rolling element 114 is specifically disposed between the first joint main body 113 a and the guide groove 111 c on the inner wall of the first rotating element 111 . The rolling element 114 is spherical, and the diameter matches the width of the guide groove 111c, so that the rolling element 114 is restricted from rolling in the guide groove 113c but will not fall off from the receiving groove 113c. The number of rolling elements 114 is at least one, preferably two in this embodiment and symmetrically arranged, while the number of guide grooves 111c is not less than the number of rolling elements 114, and the number of guide grooves 111c in this embodiment is also two. It can be understood that, in other embodiments, the receiving groove may also be a quarter spherical groove, a third spherical groove, a fifth spherical groove, or the like. The quarter spherical groove refers to the groove corresponding to the quarter diameter obtained by cutting the spherical structure in the direction perpendicular to the diameter at the quarter diameter of the hollow spherical structure. . The definition methods of one-third spherical groove, one-fifth spherical groove and quarter spherical groove are similar, and will not be repeated here.

当手动转动第一旋转件111时,会带动滚动件114滚动,由于第一旋转件111被手柄壳体限制了只能周向转动,而导向件112又限制固定件113只发生轴向移动。因此滚动件114的滚动将带动固定件113轴向移动,从而带动与固定件113连接的外鞘导管21的轴向运动。通过导向件112将第一旋转件111的周向转动转变成外鞘导管21的轴向运动,使得外鞘导管沿轴向运动的力大大减小,同时缩短了输送装置01的整体轴向尺寸。When the first rotating member 111 is manually rotated, the rolling member 114 will be driven to roll. Since the first rotating member 111 is restricted by the handle housing to rotate in the circumferential direction, and the guide member 112 restricts the fixed member 113 to only move axially. Therefore, the rolling of the rolling element 114 will drive the fixing element 113 to move axially, thereby driving the axial movement of the sheath catheter 21 connected to the fixing element 113 . The circumferential rotation of the first rotating member 111 is converted into the axial movement of the outer sheath catheter 21 through the guide member 112, so that the force of the outer sheath catheter moving in the axial direction is greatly reduced, and the overall axial dimension of the delivery device 01 is shortened at the same time .

在其它实施例中,也可省略导向件,例如通过在手柄壳体内设置限位条,保证固定件不会相对于手柄壳体发生周向转动即可。In other embodiments, the guide member may also be omitted, for example, by arranging a limit bar in the handle housing to ensure that the fixing member does not rotate in the circumferential direction relative to the handle housing.

同时参阅图8和图9,第二制动单元12包括第二旋转件122和与连接导管23相连的连接件121。第二旋转件122具有呈台阶状的轴向通孔125,且远端设有能收容连接导管23的开口。轴向通孔125包括孔径较大的远端部125a和孔径较小的近端部125b。优选地,本实施例中,远端部125a的横截面为矩形。连接件121位于轴向通孔125的远端部125a,且连接部121与远端部125a的形状相匹配,使得连接件121相对第二旋转件122仅能轴向移动,而无法周向转动。本实施例中,连接部121的截面也为矩形。连接导管23的近端通过连接件121收容于第二旋转件122的通孔内。再次参阅图1,第二旋转件122的外侧部分外露于手柄壳体外,操作者可以操作转动第二旋转件122,从而带动连接导管23周向转动。可以理解的是,其它实施例中,远端部125a的截面形状也可以为三角形、菱形、五边形、椭圆形等,只要连接件121与远端部125a的形状相匹配,使得连接件121相对第二旋转件122仅能轴向移动,而无法周向转动即可。Referring to FIG. 8 and FIG. 9 simultaneously, the second braking unit 12 includes a second rotating member 122 and a connecting member 121 connected with the connecting conduit 23 . The second rotating member 122 has a stepped axial through hole 125 , and a distal end thereof is provided with an opening capable of accommodating the connecting conduit 23 . The axial through hole 125 includes a distal end portion 125a with a larger bore and a proximal end portion 125b with a smaller bore. Preferably, in this embodiment, the cross section of the distal end portion 125a is rectangular. The connecting member 121 is located at the distal end portion 125a of the axial through hole 125, and the shape of the connecting portion 121 and the distal end portion 125a match, so that the connecting member 121 can only move axially relative to the second rotating member 122, but cannot rotate in the circumferential direction . In this embodiment, the cross section of the connecting portion 121 is also rectangular. The proximal end of the connecting catheter 23 is received in the through hole of the second rotating member 122 through the connecting member 121 . Referring to FIG. 1 again, the outer portion of the second rotating member 122 is exposed outside the handle housing, and the operator can operate and rotate the second rotating member 122 to drive the connecting conduit 23 to rotate in the circumferential direction. It can be understood that, in other embodiments, the cross-sectional shape of the distal portion 125a may also be a triangle, a rhombus, a pentagon, an ellipse, etc., as long as the connecting member 121 matches the shape of the distal portion 125a, so that the connecting member 121 The relative second rotating member 122 can only move in the axial direction, but cannot rotate in the circumferential direction.

靠近第二旋转件122的远端还同轴设有用于收容推杆导管22近端的第二接头主体33,且连接导管23贯穿推杆导管22的同时也贯穿第二接头主体33。通过将第二接头主体33固定于手柄壳体内壁实现对推杆导管的固定。第二接头主体33上还设有与第一阀31相通的开口,供冲洗输送装置01内部时使用。A second joint body 33 for accommodating the proximal end of the push rod catheter 22 is also coaxially disposed near the distal end of the second rotating member 122 . The fixing of the push rod conduit is realized by fixing the second joint body 33 to the inner wall of the handle housing. The second joint main body 33 is also provided with an opening communicating with the first valve 31 , which is used for flushing the inside of the conveying device 01 .

第三制动单元13设于输送装置01的最近端,具体包括第三旋转件131、与第三旋转件131螺接的调节管132以及推动导管24。第三旋转件131设于手柄壳体50的近端端部,具有中空内腔和内壁,且内壁上设有内螺纹。调节管132穿设于第三旋转件131的内腔内,且设有与第三旋转件131内壁的内螺纹相配合的外螺纹。调节管132内部设有轴向通孔,该轴向通孔与第二阀32相通。推动导管24的近端从调节管132的远端穿至调节管132的轴向通孔内,且固定于调节管132内;推动导管24的远端从第二旋转件12的近端开口穿入且可与连接件121近端端面相抵。通过转动第三旋转件131,可以带动调节管132朝向远端移动,因推动导管24相对于调节管132固定,推动导管24随调节管132朝向远端的移动,待推动导管24的远端抵接连接件121的近端,继续同向旋转第三旋转件131,则继续向远端移动的推动导管24即可推动连接导管23向远端移动,使得连接导管23的远端从推杆导管22的远端端面伸出。应当注意,本发明的第三制动单元13只能制动连接导管23向远端移动,不能制动连接导管23向近端移动,但第三制动单元13回撤使推动导管24远端与连接件121不接触时,连接导管23可在外力的作用下朝向近端移动。The third braking unit 13 is disposed at the proximal end of the conveying device 01 , and specifically includes a third rotating member 131 , an adjusting tube 132 screwed to the third rotating member 131 , and a pushing conduit 24 . The third rotating member 131 is disposed at the proximal end of the handle housing 50 and has a hollow inner cavity and an inner wall, and the inner wall is provided with an inner thread. The adjusting tube 132 is inserted through the inner cavity of the third rotating member 131 and is provided with an external thread matching with the internal thread on the inner wall of the third rotating member 131 . An axial through hole is provided inside the regulating pipe 132 , and the axial through hole communicates with the second valve 32 . Push the proximal end of the catheter 24 to pass from the distal end of the adjustment tube 132 into the axial through hole of the adjustment tube 132, and be fixed in the adjustment tube 132; into and can abut against the proximal end face of the connector 121 . By rotating the third rotating member 131, the adjusting tube 132 can be driven to move towards the distal end. Since the pushing conduit 24 is fixed relative to the adjusting tube 132, the pushing conduit 24 moves with the adjusting tube 132 towards the distal end, and the distal end of the pushing conduit 24 is pushed against the distal end. Connect the proximal end of the connecting member 121, and continue to rotate the third rotating member 131 in the same direction, then the pushing catheter 24 that continues to move to the distal end can push the connecting catheter 23 to move distally, so that the distal end of the connecting catheter 23 is removed from the push rod catheter. The distal end face of 22 protrudes. It should be noted that the third braking unit 13 of the present invention can only brake the connecting catheter 23 to move to the distal end, but cannot brake the connecting catheter 23 to move to the proximal end, but the third braking unit 13 retracts to push the distal end of the catheter 24 When not in contact with the connecting piece 121, the connecting catheter 23 can move toward the proximal end under the action of an external force.

优选地,第二制动单元12和第二接头主体33内也分别设有能起到密封锁紧作用的第二密封圈40c和第三密封圈40b,能分别锁紧推动导管24和连接导管23。Preferably, the second braking unit 12 and the second joint body 33 are also provided with a second sealing ring 40c and a third sealing ring 40b, which can play a sealing and locking role, respectively, and can lock the pushing conduit 24 and the connecting conduit respectively. twenty three.

在其它实施例中,也可以省略推动导管,例如连接导管的近端段与具有台阶孔的调节管的台阶处抵接,只要第二调节件可以驱动连接导管轴向移动,且不影响连接导管的周向转动即可。In other embodiments, the pushing catheter can also be omitted, for example, the proximal end section of the connecting catheter abuts the step of the adjusting tube with the stepped hole, as long as the second adjusting member can drive the connecting catheter to move axially without affecting the connecting catheter can rotate in the circumferential direction.

综上,以下具体阐述本发明的输送装置01的使用方法。初始状态下,本发明的输送装置01的导管组件20中各导管的位置关系为:连接导管23的远端端面伸出推杆导管22的远端端面,推杆导管22的远端端面位于外鞘导管21的内腔内,推动导管24远端与连接件121不接触。在使用本发明的输送装置01进行人工心脏瓣膜植入时,首先需要将人工心脏瓣膜装载至输送装置01上。具体地,首先转动第一旋转件111,制动外鞘导管21向近端移动,使推杆导管22的远端从外鞘导管21的远端露出。再通过螺纹连接将人工心脏瓣膜连接至连接导管23上。最后再次转动第一旋转件111,使外鞘导管21向远端移动,将连接导管23和人工心脏瓣膜一并收至外鞘导管21的内腔内。此时,外鞘导管21对人工心脏瓣膜的力间接地传递给连接导管23,使得连接导管23相对推杆导管22朝向近端作轴向运动,移动的连接导管23推动连接件121与推动导管24远端端面相抵,连接导管23的远端再次退回至推杆导管22的内腔内,从而完成人工心脏瓣膜的装载。In conclusion, the usage method of the conveying device 01 of the present invention will be described in detail below. In the initial state, the positional relationship of each conduit in the conduit assembly 20 of the delivery device 01 of the present invention is as follows: the distal end face of the connecting conduit 23 protrudes from the distal end face of the push rod conduit 22, and the distal end face of the push rod conduit 22 is located outside. In the lumen of the sheath catheter 21 , the distal end of the pushing catheter 24 is not in contact with the connector 121 . When the artificial heart valve is implanted using the delivery device 01 of the present invention, the artificial heart valve needs to be loaded on the delivery device 01 first. Specifically, firstly, the first rotating member 111 is rotated, and the outer sheath catheter 21 is braked to move toward the proximal end, so that the distal end of the push rod catheter 22 is exposed from the distal end of the outer sheath catheter 21 . Then, the artificial heart valve is connected to the connecting catheter 23 through screw connection. Finally, the first rotating member 111 is rotated again to move the outer sheath catheter 21 to the distal end, and the connecting catheter 23 and the artificial heart valve are received into the lumen of the outer sheath catheter 21 together. At this time, the force of the outer sheath catheter 21 on the artificial heart valve is indirectly transmitted to the connecting catheter 23, so that the connecting catheter 23 moves axially toward the proximal end relative to the push rod catheter 22, and the moving connecting catheter 23 pushes the connector 121 and pushes the catheter. The distal end faces of 24 abut against each other, and the distal end of the connecting catheter 23 is retracted into the lumen of the push rod catheter 22 again, thereby completing the loading of the artificial heart valve.

通过输送装置01将人工心脏瓣膜输送至合适位置后,需要对人工心脏瓣膜进行释放。具体地,首先转动第一旋转件111,制动外鞘导管21朝向近端移动,撤消外鞘导管21对人工心脏瓣膜的束缚力,使人工心脏瓣膜扩张。然后转动第二旋转件122,带动连接导管23周向转动,释放人工心脏瓣膜。从而完成人工心脏瓣膜的释放。可以理解的是,如有需要,可以在转动第二旋转件122释放人工心脏瓣膜前,转动第三旋转件131使得连接导管23的远端稍伸出推杆导管22远端端面,这样释放人工心脏瓣膜的时候更加方便。After the prosthetic heart valve is delivered to a proper position by the delivery device 01, the prosthetic heart valve needs to be released. Specifically, firstly, the first rotating member 111 is rotated to stop the outer sheath catheter 21 from moving toward the proximal end, and the binding force of the outer sheath catheter 21 to the artificial heart valve is cancelled, so that the artificial heart valve is expanded. Then, the second rotating member 122 is rotated to drive the connecting catheter 23 to rotate in the circumferential direction to release the artificial heart valve. Thus, the release of the artificial heart valve is completed. It can be understood that, if necessary, before rotating the second rotating member 122 to release the artificial heart valve, the third rotating member 131 can be rotated so that the distal end of the connecting catheter 23 slightly protrudes from the distal end face of the push rod catheter 22, thus releasing the artificial heart valve. It is more convenient when the heart valve is used.

当人工心脏瓣膜释放位置不佳或在体外装载瓣膜需要重新将人工心脏瓣膜连接至连接导管时,可以转动第三旋转件131,利用推动导管24推动连接导管23向远端运动,连接导管23设有螺纹结构的远端从推杆导管22的远端露出。再次转动第三旋转件131,使推动导管24部分回撤,即推动导管24的远端不再与连接件121相抵。再进行人工心脏瓣膜与连接导管23的连接。因此,可以理解的是,在其它实施例中,若无需反复释放和回收人工心脏瓣膜,则可以省略第三制动单元。When the release position of the artificial heart valve is not good or the artificial heart valve needs to be reconnected to the connecting catheter when the valve is loaded outside the body, the third rotating member 131 can be rotated, and the connecting catheter 23 can be pushed to the distal end by the pushing catheter 24, and the connecting catheter 23 is set. The distal end of the threaded structure emerges from the distal end of the push rod catheter 22 . The third rotating member 131 is rotated again to partially withdraw the pushing catheter 24 , that is, the distal end of the pushing catheter 24 is no longer in contact with the connecting member 121 . The artificial heart valve is then connected to the connecting catheter 23 . Therefore, it can be understood that, in other embodiments, the third braking unit may be omitted if the prosthetic heart valve does not need to be released and recovered repeatedly.

进一步地,在其它实施例中,还可以将推杆导管的远端设置成锥形结构,锥形结构的锥角朝向远端。这样的设计可以在释放人工心脏瓣膜但位置不理想时通过制动组件的配合重新将人工心脏瓣膜连接至连接导管上,调整位置后重新释放。此时,推杆导管远端的锥形结构主要起到穿刺的作用,这样不需要重新穿刺,能及时调整人工心脏瓣膜的位置,大大节省了心脏瓣膜位置释放不佳时的手术时间。Further, in other embodiments, the distal end of the push rod catheter can also be set into a tapered structure, and the taper angle of the tapered structure is toward the distal end. Such a design can re-connect the artificial heart valve to the connecting catheter through the cooperation of the braking component when the artificial heart valve is released but the position is not ideal, and the artificial heart valve can be re-released after adjusting the position. At this time, the tapered structure at the distal end of the push rod catheter mainly plays the role of puncturing, so that there is no need to re-puncture, the position of the artificial heart valve can be adjusted in time, and the operation time when the position of the heart valve is not released is greatly saved.

具体以将人工心脏瓣膜植入人体心脏为例说明本发明的输送装置01的使用方法。请同时参阅图10a至图10g,图中同时示出了人体心脏的基本解剖结构,包括左心房LA、左心室LV、左心房RA和右心室RV。在使用本发明的输送装置01前,首先在左前侧胸部第五或者第六肋间隙切开微切口,经切口纵向打开心包并缝合后暴露出心尖,接着在靠近心尖部进行心尖荷包310缝合,如图10a所示。接着,使用穿刺针对心尖进行穿刺,向前插入一根软导丝320进入心脏左心室,如图10b所示。随后撤出穿刺针,沿着导丝320送入远端预塑形的短鞘管330和远端带球囊341的扩张器管340,其中导丝320位于扩张器管340内,扩张器管340位于短鞘管330内,如图10c所示,此外短鞘管330或扩张器管340的远端或者两者的远端均可设显影环350。然后,使球囊341扩张充盈(如图10d),扩张后的形状为球型或者椭圆型,最大外径在8-15mm之间,避免后续操作过程中,腱索对入路的干扰。紧接着,在DSA和超声的辅助下,导丝320经二尖瓣到达左心房,建立体外到左心房的轨道。然后保留位于左心房的导丝320,撤出短鞘管330和扩张器管340,接着沿导丝320插入心尖扩张装置360,通过心尖扩张管361逐渐扩张心尖穿刺点,将心尖扩张外导管362的远端送入到左心室内,如图10e所示。接着,撤出心尖扩张管361,使心尖扩张外导管362保留在心脏内。将输送装置01的导管组件20沿导丝320递送至心脏,外鞘导管21的远端穿过二尖瓣,使得外鞘导管21的显影环211与二尖瓣相平行,位同一水平面上。当位置确认无误后,旋转第一旋转件111,向近端收回外鞘导管21,从而移除对人工心脏瓣膜远端的部分径向约束力,人工心脏瓣膜近端部分仍在回收导管22的内腔内,如图10f所示。继续向相同方向转动第一旋转件111,随着外鞘导管21被进一步回撤,人工心脏瓣膜径向向外自扩张,当人工心脏瓣膜整体露出外鞘导管21后,旋转第三旋转件131,将连接导管23的远端露出推杆导管22的远端,如图10g所示。此时旋转第二旋转件122,使得连接导管23也随着转动,从而使连接导管23与人工心脏瓣膜的螺纹连接解脱,完成人工心脏瓣膜的最终释放。Specifically, the method of using the delivery device 01 of the present invention will be described by taking the artificial heart valve implanted into the human heart as an example. Please refer to FIG. 10a to FIG. 10g at the same time, which simultaneously show the basic anatomical structure of the human heart, including the left atrium LA, the left ventricle LV, the left atrium RA and the right ventricle RV. Before using the delivery device 01 of the present invention, a micro-incision is first made in the fifth or sixth intercostal space of the left anterior chest, the pericardium is longitudinally opened through the incision and sutured to expose the apex, and then the apex purse 310 is sutured near the apex. As shown in Figure 10a. Next, the apex of the heart is punctured using the puncture target and a soft guide wire 320 is inserted forward into the left ventricle of the heart, as shown in Figure 10b. Then, the puncture needle is withdrawn, and the pre-shaped short sheath tube 330 at the distal end and the dilator tube 340 with the balloon 341 at the distal end are fed along the guide wire 320, wherein the guide wire 320 is located in the dilator tube 340, and the dilator tube 340 is located in the short sheath tube 330, as shown in FIG. 10c, in addition, the distal end of the short sheath tube 330 or the dilator tube 340 or the distal end of both may be provided with a developing ring 350. Then, the balloon 341 is expanded and filled (as shown in FIG. 10d ). The expanded shape is spherical or elliptical, and the maximum outer diameter is between 8-15 mm, so as to avoid the interference of the chordae tendineae on the approach during the subsequent operation. Immediately thereafter, with the aid of DSA and ultrasound, the guide wire 320 is passed through the mitral valve to the left atrium, establishing an extracorporeal track to the left atrium. Then, the guide wire 320 located in the left atrium is retained, the short sheath tube 330 and the dilator tube 340 are withdrawn, and then the apical dilation device 360 is inserted along the guide wire 320, and the apical puncture point is gradually expanded through the apical dilation tube 361, and the apical dilation outer catheter 362 into the left ventricle, as shown in Figure 10e. Next, the apical dilation catheter 361 is withdrawn, and the apical dilation outer catheter 362 remains in the heart. The catheter assembly 20 of the delivery device 01 is delivered to the heart along the guide wire 320, and the distal end of the sheath catheter 21 is passed through the mitral valve, so that the developing ring 211 of the sheath catheter 21 is parallel to the mitral valve and on the same level. When the position is confirmed to be correct, rotate the first rotating member 111 to retract the sheath catheter 21 towards the proximal end, thereby removing part of the radial restraint on the distal end of the prosthetic heart valve, and the proximal part of the prosthetic heart valve is still in the retraction of the catheter 22 inside the lumen, as shown in Figure 10f. Continue to rotate the first rotating member 111 in the same direction, as the outer sheath catheter 21 is further withdrawn, the artificial heart valve self-expands radially outwards, when the artificial heart valve as a whole exposes the outer sheath catheter 21, rotate the third rotating member 131 , expose the distal end of the connecting catheter 23 to the distal end of the push rod catheter 22, as shown in Figure 10g. At this time, the second rotating member 122 is rotated, so that the connecting catheter 23 is also rotated, so that the threaded connection between the connecting catheter 23 and the artificial heart valve is released, and the final release of the artificial heart valve is completed.

输送装置01在装载人工心脏瓣膜时,首先将假体瓣膜近端延伸出的系绳穿入到连接导管23内,系绳近端再从连接导管23的近端伸出,接着旋转第三旋旋转件131,推动导管24沿轴向向远端位移,推动连接件121,使得连接导管23的远端露出推杆导管22的远端,连接导管23的远端螺纹与人工心脏瓣膜进行螺纹连接组装。组装完成后,旋转第三旋转件131回初始位置,使得推动导管24后撤,远离连接件121。此时旋转第一旋转件111,将外鞘导管21向远端移动,人工心脏瓣膜将会逐渐收入到外鞘导管21中。此时由于外鞘导管21对人工心脏瓣膜的力间接地传递给连接导管23,使得连接导管23相对推杆导管22朝向近端作轴向运动,移动的连接导管23推动连接件121与推动导管24远端端面相抵,连接导管23的远端再次退回至推杆导管22的内腔内,从而完成人工心脏瓣膜的装载。When loading the prosthetic heart valve, the delivery device 01 first inserts the tether extending from the proximal end of the prosthetic valve into the connecting catheter 23, and then the proximal end of the tether protrudes from the proximal end of the connecting catheter 23, and then rotates a third rotation. The rotating member 131 pushes the catheter 24 to move to the distal end in the axial direction, and pushes the connecting member 121, so that the distal end of the connecting catheter 23 exposes the distal end of the push rod catheter 22, and the distal thread of the connecting catheter 23 is threaded with the artificial heart valve. assembled. After the assembly is completed, the third rotating member 131 is rotated back to the original position, so that the pushing catheter 24 is withdrawn and away from the connecting member 121 . At this time, the first rotating member 111 is rotated to move the outer sheath catheter 21 to the distal end, and the artificial heart valve will gradually be received into the outer sheath catheter 21 . At this time, the force of the outer sheath catheter 21 on the artificial heart valve is indirectly transmitted to the connecting catheter 23, so that the connecting catheter 23 moves axially toward the proximal end relative to the push rod catheter 22, and the moving connecting catheter 23 pushes the connecting piece 121 and the pushing catheter. The distal end faces of 24 abut against each other, and the distal end of the connecting catheter 23 is retracted into the lumen of the push rod catheter 22 again, thereby completing the loading of the artificial heart valve.

以上实施例仅为本发明的优选实施方式,无法对所有可选方式进行一一列举,因此不能认为以上实施方式是对本发明的限制。同时,本领域的技术人员可以根据实际需求对相应的部分结构或连接方式进行简单更改和替换,本发明的保护范围以权利要求为准。The above embodiments are only preferred embodiments of the present invention, and all optional modes cannot be listed one by one, so the above embodiments cannot be considered to limit the present invention. Meanwhile, those skilled in the art can simply modify and replace the corresponding partial structures or connection modes according to actual needs, and the protection scope of the present invention is subject to the claims.

Claims (10)

1. a kind of medical instrument conveying device, which is characterized in that be connected including hollow epitheca conduit and with the epitheca conduit First brake unit, first brake unit include the first revolving part of hollow tubular, and are contained in first rotation The interior intracavitary fixing piece of part, the fixing piece are connected with the epitheca conduit;The first revolving part inner wall is equipped with around described The side wall of the spiral guide groove of the axial direction of first revolving part, the fixing piece is equipped with accommodating grooves;The medical instrument Conveying device further includes the rolling member being located between the guide groove and accommodating grooves, and first revolving part drives when rotating The rolling member rolls in the guide groove, while driving the fixing piece and the epitheca conduit relative to first rotation Part is axially moved.
2. medical instrument conveying device according to claim 1, which is characterized in that first brake unit further includes leading To part, the guide part is set between first rotary body and the fixing piece, and the guide part has inner cavity and side wall, institute It states side wall and is equipped with the axial limiting opening communicated with the inner cavity of the guide part, the limit opening limits the fixing piece axis To mobile path.
3. medical instrument conveying device according to claim 1, which is characterized in that the conveying device further includes handle case Body, first rotary portion are set in the handle housing, the handle housing limit first revolving part relative to The handle housing only circumferentially rotates.
4. medical instrument conveying device according to claim 1, which is characterized in that the rolling member is spherical structure.
5. medical instrument conveying device according to claim 1, which is characterized in that the quantity of the rolling member is at least 1 It is a.
6. medical instrument conveying device according to claim 5, which is characterized in that the helix angle range of the guide groove It is 15~45 degree.
7. medical instrument conveying device according to claim 1, which is characterized in that the fixing piece includes the first connector master Body, first adapter body are connected with the epitheca conduit, and the rolling member is set to the first adapter body side wall and institute Between the inner wall for stating the first revolving part.
8. medical instrument conveying device according to claim 7, which is characterized in that the fixing piece further include regulating part and The first sealing ring set on the regulating part distal end, the regulating part are equipped with external screw thread, and first adapter body proximal end is also Proximal openings equipped with receiving regulating part and the first sealing ring, are equipped in the proximal openings of first adapter body and the tune Save the internal screw thread of external screw thread cooperation on part.
9. medical instrument conveying device according to any one of claim 1 to 8, which is characterized in that the conveying device It further include connecting conduit, the connecting conduit runs through the epitheca conduit.
10. medical instrument conveying device according to claim 9, which is characterized in that the connecting conduit distal end is equipped with spiral shell Line structure, the connecting conduit are connect by the helicitic texture with medical instrument.
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CN116407159A (en) * 2021-12-29 2023-07-11 深圳市先健呼吸科技有限公司 A biopsy device
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