CN111329564A - Safe pericardial puncture device and using method thereof - Google Patents

Abstract

The invention discloses a puncture needle, which consists of a needle body and a needle seat, wherein the head end of the needle body is bent laterally, a needle opening is formed on the inner side surface of the bend and is vertical to the longitudinal axis of the needle body, and the needle point is an arc-shaped cutting surface. Accordingly, the inventor also designs a matched guide wire catapult, and the guide wire catapult and the safe pericardium puncture device are formed together. The puncture needle with the lateral opening can reduce the sharpness of the tip of the puncture needle, change the direction of an outlet and reduce the risk that the puncture needle and a guide wire stab the heart; the guide wire bouncing device is matched with the puncture needle for use, the guide wire can be automatically bounced from the lateral needle opening into the pericardial cavity at the moment when the needle opening completely enters the pericardium, the heart is prevented from being hurt by the puncture needle point stabbed by the puncture needle and the heart is damaged by the guide wire directly bouncing to the heart by the puncture needle inadvertently, and the heart is immediately protected. Therefore, the invention can be used for conveniently and rapidly carrying out pericardiocentesis and is safe, stable and reliable.

Description

Translated fromChinese

安全心包穿刺装置及其使用方法Safe pericardiocentesis device and method of use

技术领域technical field

本发明属于心包穿刺技术领域，尤其涉及一种安全心包穿刺装置及其使用方法。The invention belongs to the technical field of pericardiocentesis, and in particular relates to a safety pericardiocentesis device and a use method thereof.

背景技术Background technique

心包穿刺是临床上诊断和治疗心包积液、心外膜途径消融室性心律失常的重要方法。由于心包腔狭小、穿刺安全窗窄、临近重要脏器、心脏不停搏动、心脏表面密布冠状动脉和静脉，因此心包穿刺的风险较高。传统的心包穿刺易损伤心脏及其血管、邻近脏器，可导致急性心包填塞、血气胸、腹腔脏器损伤、肺损伤等并发症，严重时需要心包引流、输血、开胸手术、腹腔探查、组织脏器外科修复等，给患者造成重大损害和经济负担，也给医师造成重大压力。研究表明，心包穿刺时，由不经意穿刺到心肌组织所致明显心包积液的发生率为3.7％-10％([1]陈恋.难治性室性心律失常导管消融改良技术的初步探索性研究[D].北京协和医学院,2017.)。Pericardiocentesis is an important method for clinical diagnosis and treatment of pericardial effusion and epicardial ablation of ventricular arrhythmias. The risk of pericardiocentesis is high due to the narrow pericardial space, narrow safety window for puncture, proximity to vital organs, the beating heart, and dense coronary arteries and veins on the surface of the heart. Traditional pericardiocentesis can easily damage the heart and its blood vessels, and adjacent organs, which can lead to complications such as acute cardiac tamponade, hemopneumothorax, abdominal organ damage, and lung damage. In severe cases, pericardial drainage, blood transfusion, thoracotomy, abdominal exploration, Surgical repair of tissues and organs, etc., has caused significant damage and economic burden to patients, and also caused great pressure to physicians. Studies have shown that during pericardiocentesis, the incidence of obvious pericardial effusion caused by inadvertent puncture to myocardial tissue is 3.7%-10% ([1] Chen Lian. Preliminary exploration of improved catheter ablation technology for refractory ventricular arrhythmias. Research [D]. Peking Union Medical College, 2017.).

目前，心包穿刺的引导方法有超声定位后盲穿，超声实时引导穿刺，CT引导穿刺，DSA引导穿刺，心外膜电图监测下穿刺，三维电生理仪引导穿刺。常用的穿刺针如以下文献报道：At present, the guidance methods of pericardiocentesis include blind puncture after ultrasound positioning, real-time ultrasound guided puncture, CT-guided puncture, DSA-guided puncture, puncture under epicardial electrogram monitoring, and three-dimensional electrophysiology-guided puncture. Commonly used puncture needles are reported in the following literatures:

1、胸穿针([2]刘可权,李升金,由娜,夏明凯,吴京红.心包穿刺引流术的方法、并发症及处理对策[J].临床荟萃,2002,06:365-367.)1. Chest puncture ([2] Liu Kequan, Li Shengjin, You Na, Xia Mingkai, Wu Jinghong. Methods, complications and treatment strategies of pericardiocentesis and drainage [J]. Clinical Metadata, 2002, 06:365-367.)

2、中心静脉穿刺针([3]李杰,周谊,贾雍,高静,飞尔顿.中心静脉导管在心包积液穿刺引流中的临床效果[J].中国医药指南,2014,24:26-27.)2. Central venous puncture needle ([3] Li Jie, Zhou Yi, Jia Yong, Gao Jing, Feilton. The clinical effect of central venous catheter in puncture and drainage of pericardial effusion [J]. Chinese Medicine Guide, 2014, 24 :26-27.)

3、Tuohy针([4]黄科昌,李光宗.几种Tuohy硬膜外穿刺针针尖的形态测量及其临床意义[J].临床麻醉学杂志,2003,09:580-581.)3. Tuohy needle ([4] Huang Kechang, Li Guangzong. Morphological measurement and clinical significance of several Tuohy epidural needle tips [J]. Journal of Clinical Anesthesiology, 2003, 09:580-581.)

4、Pajunk针([5]郭敏.Pajunk增强回声针在臂丛神经阻滞中应用效果评价[D].皖南医学院,2018.)4. Pajunk needle ([5] Guo Min. Evaluation of the application effect of Pajunk echo-enhancing needle in brachial plexus block [D]. Wannan Medical College, 2018.)

上述穿刺针的共同的特点是尖端锐利且缺乏保护机制，容易刺伤心脏及其血管引起一系列并发症。因此，临床上亟需一种更为安全有效以避免心包穿刺误伤心脏及其血管的医疗装置及其穿刺方法。The common feature of the above-mentioned puncture needles is that the tip is sharp and lacks a protective mechanism, which can easily puncture the heart and its blood vessels and cause a series of complications. Therefore, there is an urgent need for a more safe and effective medical device and a puncturing method for avoiding accidental injury to the heart and its blood vessels by pericardiocentesis.

发明内容SUMMARY OF THE INVENTION

本发明要解决的技术问题是提供一种结构简单合理、使用方便快捷且稳定可靠的安全心包穿刺装置及其使用方法。The technical problem to be solved by the present invention is to provide a safe pericardiocentesis device with a simple and reasonable structure, convenient and fast use, stability and reliability, and a use method thereof.

为解决上述技术问题，本发明采用以下技术方案：In order to solve the above-mentioned technical problems, the present invention adopts the following technical solutions:

穿刺针，由针体和针座构成，针体头端侧向弯曲，针口开在弯曲内侧面并与针体纵轴垂直，针尖为弧形切割面。The puncture needle is composed of a needle body and a needle seat, the head end of the needle body is laterally curved, the needle opening is opened on the inner side of the curve and is perpendicular to the longitudinal axis of the needle body, and the needle tip is an arc-shaped cutting surface.

安全心包穿刺装置，包括导丝弹送器和穿刺针；Safety pericardiocentesis devices, including guide wire ejectors and needles;

导丝弹送器主要由低阻力注射器组成，低阻力注射器包括外套筒、导丝管和芯杆；外套筒前端有锥头，外套筒尾端开口处有卷边，卷边之外紧扣一底板，底板中央有一与外套筒开口呈同心圆的孔洞；外套筒的后段内置弹簧，弹簧后端承托于底板内壁；外套筒中部设有卡钉和卡口，卡钉穿过卡口嵌入外套筒内；锥头与外套筒内同轴的导丝管头端紧密连接，且锥头孔与导丝管内腔平滑贯通，导丝管的前段与锥头孔连接处有两个侧孔与外套筒内腔相通；芯杆包括核心管，核心管套在同轴的导丝管外，核心管的中央空腔贯穿头尾两端，核心管伸出底板的末端设有阀门；核心管头端设活塞，活塞套有密封圈；活塞之后的核心管外壁有四个相互垂直、四向放射排列的支撑板；支撑板的向心端与核心管相连，边缘端靠近外套筒内壁；在同一平面的一对支撑板上的边缘端排列两组方向相反的扇形卡片，沿着核心管纵轴方向设置数个扇形卡片，两个相邻的扇形卡片之间形成一个卡槽，每一个卡槽内的支撑板上有一个能通过卡钉的缺口；卡槽之后的核心管上有一垂直的隔板，隔板与活塞平行，弹簧圈前端抵住隔板；The guide wire ejector is mainly composed of a low-resistance syringe. The low-resistance syringe includes an outer sleeve, a guide wire tube and a core rod; the front end of the outer sleeve has a tapered head, and the opening at the end of the outer sleeve has a curling edge, which is tightly fastened outside the curling edge. a bottom plate, a hole in the center of the bottom plate that is concentric with the opening of the outer sleeve; a spring is built in the rear section of the outer sleeve, and the rear end of the spring is supported on the inner wall of the bottom plate; It is inserted into the outer sleeve through the bayonet; the cone head is closely connected with the coaxial guide wire head end in the outer sleeve, and the cone head hole and the guide wire tube lumen are smoothly connected, and the front section of the guide wire tube is connected with the cone head hole. There are two side holes communicated with the inner cavity of the outer sleeve; the core rod includes a core tube, the core tube is sleeved outside the coaxial guide wire tube, the central cavity of the core tube runs through both ends of the head and tail, and the core tube extends from the end of the bottom plate There is a valve; the head end of the core tube is provided with a piston, and the piston sleeve is provided with a sealing ring; the outer wall of the core tube behind the piston has four mutually perpendicular and radially arranged support plates; the centripetal end of the support plate is connected with the core tube, and the edge end close to the inner wall of the outer sleeve; two groups of fan-shaped cards in opposite directions are arranged on the edge ends of a pair of support plates on the same plane, and several fan-shaped cards are arranged along the longitudinal axis of the core tube, and two adjacent fan-shaped cards are formed between There is a card slot, and the support plate in each card slot has a gap that can pass through the clip; the core tube behind the card slot has a vertical partition, the partition is parallel to the piston, and the front end of the spring coil is against the partition;

穿刺针的针座与导丝弹送器的锥头通过螺口接头紧密连接，导丝经由阀门贯穿核心管和导丝管，再从锥头孔穿过针座贯穿针体。The needle seat of the puncture needle is tightly connected with the cone head of the guide wire ejector through a screw joint, the guide wire passes through the core tube and the guide wire tube through the valve, and then passes through the needle seat through the cone head hole and penetrates the needle body.

针体或导丝管由医用不锈钢管构成，针体尾端与针座相连接。The needle body or the wire guide tube is composed of a medical stainless steel tube, and the tail end of the needle body is connected with the needle seat.

针体的医用不锈钢管的规格为16G-18G、有效长度为8-16cm；导丝管的医用不锈钢管的规格为16G、长度与外套筒相当；导丝为直径≤0.035英寸的J型引导钢丝。The specification of the medical stainless steel tube of the needle body is 16G-18G, and the effective length is 8-16cm; the specification of the medical stainless steel tube of the guide wire is 16G, and the length is equivalent to the outer sleeve; the guide wire is a J-type guide with a diameter of ≤0.035 inches steel wire.

锥头为中头式固定连接的内螺纹卡圈的外圆锥锁定接头。The conical head is the outer conical locking joint of the inner thread collar of the middle head type fixed connection.

弹簧长≥2.5-3.5cm。Spring length ≥2.5-3.5cm.

沿着核心管纵轴方向，每隔0.5cm距离设一扇形卡片，共4-6个扇形卡片。Along the longitudinal axis of the core tube, set up a fan-shaped card every 0.5cm distance, a total of 4-6 fan-shaped cards.

安全心包穿刺装置的使用方法，将穿刺针的针座与导丝弹送器的锥头通过螺口接头紧密连接，导丝送入芯杆中央腔，由阀门贯穿核心管和导丝管，再从锥头孔穿过针座贯穿针体抵达针口；推送穿刺针至目标位置时，导丝在导丝弹送器的作用下从侧向针口自动弹出。The method of using the safety pericardiocentesis device is that the needle seat of the puncture needle and the cone head of the guide wire ejector are tightly connected through the screw joint, the guide wire is sent into the central cavity of the core rod, the valve passes through the core tube and the guide wire tube, and then the From the cone head hole, through the needle seat, through the needle body, and through the needle body to reach the needle port; when the puncture needle is pushed to the target position, the guide wire is automatically ejected from the side needle port under the action of the guide wire ejector.

针对目前心包穿刺存在的问题，发明人设计并制作了一种穿刺针，由针体和针座构成，针体头端侧向弯曲，针口开在弯曲内侧面并与针体纵轴垂直，针尖为弧形切割面。据此，发明人还设计了配套使用的导丝弹送器，两者共同构成安全心包穿刺装置。其中，侧向开口的穿刺针，可降低穿刺针尖端的锐度，改变出口的方向，降低穿刺针和导丝刺伤心脏的风险；同时还可避免穿刺过程中组织碎屑嵌入针口内，使导丝嵌顿，弹送失败；导丝弹送器配合穿刺针使用，在针口完全进入心包的瞬间可自动将导丝从侧向针口弹送入心包腔，避免不经意间晃动穿刺针使针尖刺伤心脏以及导丝直接弹向心脏而损伤心脏，起到即刻保护心脏作用；触发导丝弹送说明针口已经进入心包腔，有利于判断针尖的位置；此外，弹送器同时还有负压抽吸功能，在针口完全进入心包的瞬间可观察心包积液流出利于判断针口已经进入心包腔。In view of the problems existing in the current pericardiocentesis, the inventor designed and produced a puncture needle, which consists of a needle body and a needle base, the tip of the needle body is laterally curved, and the needle opening is opened on the inner side of the curve and is perpendicular to the longitudinal axis of the needle body. The tip of the needle is an arc-shaped cut surface. Accordingly, the inventor has also designed a guide wire ejector to be used together, and the two together constitute a safe pericardiocentesis device. Among them, the puncture needle with side opening can reduce the sharpness of the puncture needle tip, change the direction of the outlet, and reduce the risk of puncturing the heart by the puncture needle and the guide wire; The guide wire is incarcerated and the ejection fails; the guide wire ejector is used in conjunction with the puncture needle to automatically eject the guide wire from the lateral needle port into the pericardial cavity at the moment when the needle port completely enters the pericardium, avoiding inadvertent shaking of the puncture needle. The needle tip pierces the heart and the guide wire directly bounces to the heart and damages the heart, which plays an immediate role in protecting the heart; triggering the guide wire ejection indicates that the needle port has entered the pericardial cavity, which is helpful for judging the position of the needle tip; in addition, the ejector also has The negative pressure suction function can observe the outflow of pericardial effusion at the moment when the needle port completely enters the pericardium, which is helpful to determine that the needle port has entered the pericardial cavity.

附图说明Description of drawings

图1是穿刺针的结构示意图。Figure 1 is a schematic diagram of the structure of the puncture needle.

图2是导丝弹送装置的使用状态及结构示意图，其中：芯杆拉开，旋转芯杆，卡钉入槽，弹簧压缩。Figure 2 is a schematic diagram of the use state and structure of the guide wire ejection device, wherein: the core rod is pulled open, the core rod is rotated, the nail is inserted into the groove, and the spring is compressed.

图3是导丝弹送装置的使用状态及结构示意图，其中：旋转芯杆，卡钉出槽，弹簧释放，芯杆前移。Figure 3 is a schematic diagram of the use state and structure of the guide wire ejection device, wherein: the core rod is rotated, the staple is out of the groove, the spring is released, and the core rod moves forward.

图4是芯杆滑动位示意图一，其中：卡钉位于卡槽外，芯杆可纵向滑动。Figure 4 is a schematic diagram of the sliding position of the core rod 1, wherein: the staple is located outside the clamping slot, and the core rod can slide longitudinally.

图5是旋转芯杆示意图一其中：旋转芯杆，卡钉进入卡槽，芯杆锁止位(即芯杆不可纵向滑动)。Figure 5 is a schematic diagram of the rotating mandrel, wherein: the mandrel is rotated, the staple enters the slot, and the mandrel is locked (that is, the mandrel cannot slide longitudinally).

图6是旋转芯杆示意图二，其中：旋转芯杆，卡钉越过支撑板缺口，脱出卡槽。Figure 6 is the second schematic diagram of the rotating core rod, wherein: the rotating core rod, the clipping nail goes over the gap of the support plate and comes out of the clipping slot.

图7是芯杆滑动位示意图二，其中：芯杆可纵向滑动。Figure 7 is a second schematic diagram of the sliding position of the core rod, wherein: the core rod can slide longitudinally.

图8是组装本发明安全心包穿刺装置的示意图一，其中：安全穿刺针针座与螺口锥头紧密连接，J型导丝贯穿芯杆核心管、导丝管、锥孔和穿刺针，抵达针口，卡钉置于滑动位。8 is a schematic diagram 1 of assembling the safety pericardiocentesis device of the present invention, wherein: the safety puncture needle needle seat is tightly connected with the screw taper head, and the J-shaped guide wire penetrates the core rod core tube, the guide wire tube, the tapered hole and the puncture needle, reaching the Needle port, the staple is placed in the sliding position.

图9是组装本发明安全心包穿刺装置的示意图二，其中：原位保持导丝，拉出芯杆0.5-3.0cm，压缩弹簧；旋转芯杆，使卡钉经过支撑板上的缺口，进入卡槽，卡在卡片上，即芯杆置于锁止位；拧紧芯杆尾部阀门，使导丝固定于芯杆上，导丝与芯杆连为一体。Fig. 9 is a schematic diagram 2 of assembling the safety pericardiocentesis device of the present invention, wherein: the guide wire is kept in place, the core rod is pulled out by 0.5-3.0 cm, and the spring is compressed; The slot is stuck on the card, that is, the core rod is placed in the locking position; the valve at the end of the core rod is tightened to make the guide wire fixed on the core rod, and the guide wire and the core rod are integrated into one.

图10是应用本发明安全心包穿刺装置进行心包穿刺的操作过程示意图，其中：10 is a schematic diagram of the operation process of applying the safety pericardiocentesis device of the present invention to perform pericardiocentesis, wherein:

a局部麻醉后，切开皮肤2mm，安全穿刺针刺入皮下组织，进针接近心包壁层时，停止进针。a After local anesthesia, the skin was incised 2 mm, the safety puncture needle was inserted into the subcutaneous tissue, and the needle was stopped when the needle approached the pericardial wall.

b旋转芯杆，卡钉经过支撑板缺口移出卡槽至支撑板光滑的另一面，芯杆置于滑动位。因弹簧弹力的作用，J型导丝的头端紧紧顶住针口外的皮下组织，弹送器蓄势待发。b. Rotate the mandrel, and the staple moves out of the card slot through the gap of the support plate to the other smooth side of the support plate, and the mandrel is placed in the sliding position. Due to the elastic force of the spring, the head end of the J-shaped guide wire is tightly pressed against the subcutaneous tissue outside the needle port, and the ejector is ready to go.

c推送穿刺针突破心包壁层，针口完全进入心包腔，J型导丝头端的阻力骤然消失，在弹簧弹力的作用下，芯杆带动J型导丝前移，J型导丝即刻被弹送入心包腔。c Push the puncture needle to break through the pericardial wall layer, the needle port completely enters the pericardial cavity, and the resistance at the tip of the J-type guide wire disappears suddenly. Under the action of the spring force, the core rod drives the J-type guide wire to move forward, and the J-type guide wire is immediately bounced into the pericardial cavity.

d J型导丝弹出穿刺针，进入心包腔的瞬间，J型导丝的头端自然卷曲，恢复成圆钝的J型，避免损伤心脏。d When the J-type guide wire is ejected from the puncture needle and enters the pericardial cavity, the tip of the J-type guide wire is naturally curled and restored to a blunt J-shaped shape to avoid damage to the heart.

图中：1针口，2针体，3导丝，4针座，5锥头，6侧孔，7缺口，8卡槽，9卡钉，10卡片，11弹簧，12卷边，13底板，14阀门，15螺口接头，16导丝管，17活塞，18支撑板，19隔板，20外套筒，21中央空腔，22核心管，23心脏，24心包腔，25心包壁层，26皮下组织。In the picture: 1 needle port, 2 needle body, 3 guide wire, 4 needle seat, 5 cone head, 6 side holes, 7 notches, 8 card slots, 9 staples, 10 cards, 11 springs, 12 crimping, 13 bottom plates , 14 valve, 15 screw joint, 16 guide wire tube, 17 piston, 18 support plate, 19 diaphragm, 20 outer sleeve, 21 central cavity, 22 core tube, 23 heart, 24 pericardial cavity, 25 pericardial wall layer , 26 subcutaneous tissue.

具体实施方式Detailed ways

一、基本结构1. Basic structure

安全心包穿刺装置，包括导丝弹送器和穿刺针。Safety pericardiocentesis device, including guide wire ejector and needle.

穿刺针，由针体和针座构成，针体头端侧向弯曲，针口开在弯曲内侧面并与针体纵轴近似垂直，针尖为弧形切割面，满足于刺入心包，但不如普通笔尖式穿刺针尖锐，避免误伤心脏。A puncture needle consists of a needle body and a needle seat. The head end of the needle body is curved laterally. The needle opening is opened on the inner side of the curve and is approximately perpendicular to the longitudinal axis of the needle body. Ordinary pen-point puncture needles are sharp to avoid accidental injury to the heart.

导丝弹送器主要由YY/T 0909-2013一次性低阻力注射器为基础组成，低阻力注射器包括外套筒、导丝管和芯杆；外套筒前端有锥头，锥头为中头式固定连接的内螺纹卡圈的6％(鲁尔)外圆锥锁定接头(GB/T1962.2)。外套筒尾端开口处有卷边，卷边之外紧扣一底板，底板外轮廓与卷边一致，底板中央有一与外套筒开口呈同心圆的孔洞，孔洞比外套筒开口半径小2mm，起封挡外套内置弹簧的作用；外套筒的后段内置长≥2.5-3.5cm弹簧(弹簧的长度与卡片的距离(即弹送的距离)相当，弹簧越长弹送的距离越长)，弹簧外径小于外套筒内径而大于底板中央孔洞的直径，使弹簧后端承托于底板内壁不能脱出；外套筒中部设有卡钉和卡口，卡钉穿过卡口嵌入外套筒内，起到拦阻芯杆前后滑动作用；锥头与外套筒内同轴的导丝管头端紧密连接，且锥头孔与导丝管内腔平滑贯通，导丝管的前段与锥头孔连接处有两个侧孔与外套筒内腔相通，尾部接近外套筒尾端；芯杆包括一管状结构核心管，其中央空腔贯穿头尾两端。核心管直径稍大于16G，使其可套在同轴的导丝管外，核心管与导丝管之间的缝隙最小化，前后可自由滑动，核心管的中央空腔贯穿头尾两端，核心管伸出底板的末端设有可启闭的阀门，可控制核心管中央腔尾部开口的开启和关闭，另外还可锁定导丝；核心管头端0.5cm设活塞，活塞套有密封圈；活塞之后的核心管外壁有四个相互垂直、四向放射排列(十字排列)的支撑板；支撑板的向心端与核心管相连，边缘端靠近外套筒内壁；在同一平面的一对支撑板上的边缘端排列两组方向相反的扇形卡片，沿着核心管纵轴方向，每隔0.5cm距离设一扇形卡片，共4-6个扇形卡片，两个相邻的扇形卡片之间形成一个卡槽，旋转芯杆可使外套筒上的卡钉进/出卡槽，起到限制/不限制芯杆纵向移动的作用；每一个卡槽内的支撑板上有一个能通过卡钉的缺口，旋转芯杆可使外套筒上的卡钉通过缺口从支撑板的一面移动至另一面；卡槽之后的核心管上有一垂直的隔板，将核心管分隔为前后两段。隔板与活塞平行，核心管后段的支撑板径向缩小2mm，使得外套筒后段内置的弹簧圈抵住隔板而成为弹簧圈前端的着力点，弹簧圈后端的着力点为底板。The guide wire ejector is mainly composed of YY/T 0909-2013 disposable low-resistance syringe. The low-resistance syringe includes an outer sleeve, a guide wire tube and a core rod; the front end of the outer sleeve has a cone head, and the cone head is the middle head. 6% (Luer) male conical locking joint (GB/T1962.2) of the female threaded collar of the type fixed connection. There is a curling edge at the end opening of the outer sleeve, and a bottom plate is fastened outside the curling edge. The outer contour of the bottom plate is consistent with the curling edge. There is a hole in the center of the bottom plate that is concentric with the opening of the outer sleeve. It plays the role of the built-in spring of the blocking jacket; the rear section of the outer sleeve has a built-in spring with a length of ≥2.5-3.5cm (the length of the spring is equivalent to the distance of the card (ie, the distance of the bounce), the longer the spring, the longer the bounce distance) , the outer diameter of the spring is smaller than the inner diameter of the outer sleeve and larger than the diameter of the central hole of the bottom plate, so that the rear end of the spring is supported on the inner wall of the bottom plate and cannot be dislodged; the middle of the outer sleeve is provided with a clip and a bayonet, and the clip is inserted into the outer sleeve through the bayonet In the barrel, it plays the role of blocking the front and rear sliding of the core rod; the cone head is closely connected with the head end of the guide wire tube coaxial in the outer sleeve, and the cone head hole and the inner cavity of the wire guide tube are smoothly connected, and the front section of the wire guide tube is connected with the cone head. There are two side holes at the connection of the holes, which are communicated with the inner cavity of the outer sleeve, and the tail is close to the tail end of the outer sleeve; The diameter of the core tube is slightly larger than 16G, so that it can be sheathed outside the coaxial wire guide tube, the gap between the core tube and the wire guide tube is minimized, and the front and rear can be freely slid. The end of the core tube protruding from the bottom plate is provided with a valve that can be opened and closed, which can control the opening and closing of the opening at the tail of the central cavity of the core tube, and can also lock the guide wire; the head end of the core tube is provided with a piston 0.5cm, and the piston sleeve has a sealing ring; The outer wall of the core tube behind the piston has four support plates that are perpendicular to each other and arranged radially in four directions (cross arrangement); the centripetal end of the support plate is connected to the core tube, and the edge end is close to the inner wall of the outer sleeve; a pair of supports on the same plane Two sets of fan-shaped cards in opposite directions are arranged on the edge end of the board. Along the longitudinal axis of the core tube, a fan-shaped card is set at a distance of 0.5cm. There are 4-6 fan-shaped cards in total, and two adjacent fan-shaped cards are formed between them. A card slot, rotating the core rod can make the nail on the outer sleeve enter/exit the card slot, which can limit/unrestrict the longitudinal movement of the core rod; there is a support plate in each card slot that can pass the card nail Rotating the core rod can move the staples on the outer sleeve from one side of the support plate to the other side through the notch; there is a vertical partition on the core tube behind the slot, which separates the core tube into two front and rear sections. The diaphragm is parallel to the piston, and the support plate in the rear section of the core tube is radially reduced by 2mm, so that the spring coil built in the rear section of the outer sleeve presses against the diaphragm and becomes the force point of the front end of the spring coil, and the force point of the rear end of the spring coil is the bottom plate.

穿刺针的针座与导丝弹送器的锥头通过螺口接头紧密连接，导丝经由阀门贯穿核心管和导丝管，再从锥头孔穿过针座贯穿针体。The needle seat of the puncture needle is tightly connected with the cone head of the guide wire ejector through a screw joint, the guide wire passes through the core tube and the guide wire tube through the valve, and then passes through the needle seat through the cone head hole and penetrates the needle body.

针体或导丝管由医用不锈钢管构成，针体尾端与针座相连接。针体的医用不锈钢管的规格为16G-18G(外径1.26-1.61mm，内径0.90-1.25mm，管壁厚度约0.1mm)、有效长度为8-16cm；导丝管的医用不锈钢管的规格为16G(外径1.61mm，内径1.25mm，管壁厚度约0.1mm)，长度与外套筒相当；导丝为直径≤0.035英寸的J型引导钢丝，可自由通过医用不锈钢管内腔。The needle body or the wire guide tube is composed of a medical stainless steel tube, and the tail end of the needle body is connected with the needle seat. The specifications of the medical stainless steel tube of the needle body are 16G-18G (outer diameter 1.26-1.61mm, inner diameter 0.90-1.25mm, tube wall thickness about 0.1mm), and the effective length is 8-16cm; the specifications of the medical stainless steel tube for the guide wire It is 16G (outer diameter 1.61mm, inner diameter 1.25mm, tube wall thickness is about 0.1mm), and the length is equivalent to the outer sleeve; the guide wire is a J-type guide wire with a diameter of ≤0.035 inches, which can freely pass through the lumen of the medical stainless steel tube.

二、使用方法2. How to use

1、将穿刺针的针座与导丝弹送器的锥头通过螺口接头紧密连接，拧开导丝弹送器芯杆尾部的阀门，将直径≤0.035英寸的J型导丝送入芯杆中央腔，通过导丝管、锥头孔、针座、针体抵达安全心包穿刺装置针口。1. Tightly connect the needle seat of the puncture needle and the cone head of the guide wire ejector through the screw joint, unscrew the valve at the end of the core rod of the guide wire ejector, and feed the J-type guide wire with a diameter of ≤0.035 inches into the core rod The central cavity reaches the needle port of the safety pericardiocentesis device through the guide wire tube, the taper hole, the needle seat and the needle body.

2、局部麻醉穿刺部位，用手术刀片切开皮肤2mm，穿刺针通过切口刺入皮下组织。2. Locally anesthetize the puncture site, cut the skin 2mm with a surgical blade, and puncture the subcutaneous tissue with the puncture needle through the incision.

3、旋转芯杆至滑动位，保持导丝头端在针口，拉出芯杆0.5-3cm，同时旋转芯杆，使固定于外套筒上的卡钉进入芯杆上的卡槽，将芯杆固定在锁止位；拧紧芯杆尾部的阀门，关闭芯杆的中央腔尾部开口，同时锁紧导丝，使芯杆与导丝连为一体。3. Rotate the mandrel to the sliding position, keep the end of the guide wire at the needle port, pull out the mandrel by 0.5-3cm, and rotate the mandrel at the same time, so that the staple fixed on the outer sleeve enters the slot on the mandrel, and the The core rod is fixed in the locking position; tighten the valve at the tail of the core rod, close the opening at the tail of the central cavity of the core rod, and lock the guide wire at the same time, so that the core rod and the guide wire are integrated into one.

4、根据术前或/和术中的医学影像如超声、X线、DSA、CT等判断安全心包穿刺装置与心包的距离，推送安全心包穿刺装置使针尖接近心包壁层时，旋转芯杆，使卡钉离开卡槽，芯杆取于滑动位，导丝头端紧紧顶住针口外的皮下组织，弹簧蓄势待发。4. Judge the distance between the safe pericardiocentesis device and the pericardium according to the preoperative or/and intraoperative medical images such as ultrasound, X-ray, DSA, CT, etc. When the safe pericardiocentesis device is pushed so that the needle tip is close to the pericardial wall, rotate the core rod, The staple is removed from the slot, the core rod is in the sliding position, the tip of the guide wire is tightly pressed against the subcutaneous tissue outside the needle mouth, and the spring is ready to go.

5、继续推送安全穿刺针，当针尖突破心包壁层，完全进入心包腔的瞬间，导丝头端的阻力消失，导丝在弹簧的作用下从侧向针口自动弹入心包腔，起到即刻保护心脏的作用。在狭小的心包腔内，导丝圆钝的J型头端隔离了心脏与针尖，避免心脏损伤；导丝自动弹入心包腔，利于医师判断穿刺针已经进入心包腔，避免继续盲目操作；导丝从侧方针口弹入心包腔，避免导丝直接刺激心脏，损伤心脏或触发心律失常等意外并发症；侧方开口的针尖设计，在穿刺的过程中，避免了组织碎屑嵌入针口内，使导丝嵌顿，不能弹出。5. Continue to push the safety puncture needle. When the needle tip breaks through the pericardial wall layer and completely enters the pericardial cavity, the resistance at the tip of the guide wire disappears, and the guide wire automatically bounces into the pericardial cavity from the lateral needle port under the action of the spring. Protects the heart. In the narrow pericardial cavity, the round and blunt J-shaped tip of the guide wire isolates the heart from the needle tip to avoid heart damage; the guide wire automatically bounces into the pericardial cavity, which is helpful for doctors to determine that the puncture needle has entered the pericardial cavity and avoid blind operation; The wire bounces into the pericardial cavity from the lateral needle port, preventing the guide wire from directly stimulating the heart, damaging the heart or triggering unexpected complications such as arrhythmia. The guide wire is incarcerated and cannot be ejected.

6、拧开芯杆尾部的阀门，心包积液流出，再次确认针口已经进入心包腔。操作导丝继续深入心包腔并固定导丝；关闭阀门，回拉芯杆，可抽出心包积液，再次确认导丝已经稳定位于心包腔内。6. Unscrew the valve at the end of the mandrel, the pericardial effusion flows out, and confirm once again that the needle port has entered the pericardial cavity. Operate the guide wire to continue to penetrate into the pericardial cavity and fix the guide wire; close the valve, and pull back the mandrel to extract the pericardial effusion, and reconfirm that the guide wire has been stably located in the pericardial cavity.

7、保留导丝在心包腔内，退出穿刺针和导丝弹送器，然后沿着导丝完成心包腔内置管操作。7. Keep the guide wire in the pericardial cavity, withdraw the puncture needle and guide wire ejector, and then complete the intrapericardial cannulation operation along the guide wire.

此外，本发明安全心包穿刺装置同样可用于胸腔穿刺和腹腔穿刺等医学穿刺。其中，导丝弹送器适用于临床常用的直径≤0.035英寸的各种类型的导丝，并且易于交换导丝。In addition, the safety pericardiocentesis device of the present invention can also be used for medical puncture such as thoracentesis and abdominal puncture. Among them, the guide wire ejector is suitable for various types of guide wires with a diameter of ≤0.035 inches commonly used in clinic, and it is easy to exchange guide wires.

Claims (8)

Translated fromChinese

1.一种穿刺针，由针体和针座构成，其特征在于：所述针体头端侧向弯曲，针口开在弯曲内侧面并与针体纵轴垂直，针尖为弧形切割面。1. A puncture needle, consisting of a needle body and a needle seat, characterized in that: the head end of the needle body is laterally curved, the needle opening is opened on the inner side of the curve and is perpendicular to the longitudinal axis of the needle body, and the needle tip is an arc-shaped cutting surface. .2.一种安全心包穿刺装置，其特征在于包括导丝弹送器和权利要求1所述的穿刺针；2. A safety pericardiocentesis device, characterized in that it comprises a guide wire ejector and the described puncture needle of claim 1;所述导丝弹送器主要由低阻力注射器组成，低阻力注射器包括外套筒、导丝管和芯杆；所述外套筒前端有锥头，外套筒尾端开口处有卷边，卷边之外紧扣一底板，底板中央有一与外套筒开口呈同心圆的孔洞；所述外套筒的后段内置弹簧，弹簧后端承托于底板内壁；所述外套筒中部设有卡钉和卡口，卡钉穿过卡口嵌入外套筒内；所述锥头与外套筒内同轴的导丝管头端紧密连接，且锥头孔与导丝管内腔平滑贯通，导丝管的前段与锥头孔连接处有两个侧孔与外套筒内腔相通；所述芯杆包括核心管，核心管套在同轴的导丝管外，核心管的中央空腔贯穿头尾两端，核心管伸出底板的末端设有阀门；所述核心管头端设活塞，活塞套有密封圈；所述活塞之后的核心管外壁有四个相互垂直、四向放射排列的支撑板；所述支撑板的向心端与核心管相连，边缘端靠近外套筒内壁；在同一平面的一对支撑板上的边缘端排列两组方向相反的扇形卡片，沿着核心管纵轴方向设置数个扇形卡片，两个相邻的扇形卡片之间形成一个卡槽，每一个卡槽内的支撑板上有一个能通过卡钉的缺口；卡槽之后的核心管上有一垂直的隔板，隔板与活塞平行，弹簧圈前端抵住隔板；The guide wire ejector is mainly composed of a low-resistance syringe, and the low-resistance syringe includes an outer sleeve, a guide wire tube and a core rod; the front end of the outer sleeve is provided with a tapered head, and the opening at the tail end of the outer sleeve is provided with a curling edge. A bottom plate is fastened outside, and there is a hole in the center of the bottom plate that is concentric with the opening of the outer sleeve; the rear section of the outer sleeve has a built-in spring, and the rear end of the spring is supported on the inner wall of the bottom plate; the middle of the outer sleeve is provided with a clamp Nail and bayonet, the staple is inserted into the outer sleeve through the bayonet; the cone head is tightly connected with the coaxial guide wire head end in the outer sleeve, and the cone head hole and the inner cavity of the wire guide tube are smoothly connected, and the guide wire There are two side holes at the connection between the front section of the wire tube and the conical head hole, which are communicated with the inner cavity of the outer sleeve; the core rod includes a core tube, the core tube is sleeved outside the coaxial wire guide tube, and the central cavity of the core tube penetrates through At both ends of the head and tail, the end of the core pipe extending out of the bottom plate is provided with a valve; the head end of the core pipe is provided with a piston, and the piston sleeve is provided with a sealing ring; support plate; the center end of the support plate is connected with the core tube, and the edge end is close to the inner wall of the outer sleeve; two groups of fan-shaped cards in opposite directions are arranged on the edge ends of a pair of support plates on the same plane, along the longitudinal direction of the core tube Several fan-shaped cards are arranged in the axial direction, a card slot is formed between two adjacent fan-shaped cards, and there is a gap on the support plate in each card slot that can pass the clip; the core tube behind the card slot has a vertical The partition, the partition is parallel to the piston, and the front end of the spring coil is against the partition;所述穿刺针的针座与导丝弹送器的锥头通过螺口接头紧密连接，导丝经由阀门贯穿核心管和导丝管，再从锥头孔穿过针座贯穿针体。The needle seat of the puncture needle is tightly connected with the cone head of the guide wire ejector through a screw joint, and the guide wire passes through the core tube and the guide wire tube through the valve, and then passes through the needle seat through the cone head hole and penetrates the needle body.3.根据权利要求1所述的安全心包穿刺装置，其特征在于：所述针体或导丝管由医用不锈钢管构成，针体尾端与针座相连接。3 . The safe pericardiocentesis device according to claim 1 , wherein the needle body or the guide wire tube is composed of a medical stainless steel tube, and the tail end of the needle body is connected with the needle seat. 4 .4.根据权利要求1所述的安全心包穿刺装置，其特征在于：所述针体的医用不锈钢管的规格为16G-18G、有效长度为8-16cm；所述导丝管的医用不锈钢管的规格为16G、长度与外套筒相当；所述导丝为直径≤0.035英寸的J型引导钢丝。4. The safe pericardiocentesis device according to claim 1, characterized in that: the specification of the medical stainless steel tube of the needle body is 16G-18G, and the effective length is 8-16cm; The specification is 16G, and the length is equivalent to the outer sleeve; the guide wire is a J-type guide wire with a diameter of ≤0.035 inches.5.根据权利要求1所述的安全心包穿刺装置，其特征在于：所述锥头为中头式固定连接的内螺纹卡圈的外圆锥锁定接头。5 . The safe pericardiocentesis device according to claim 1 , wherein the conical head is an outer conical locking joint of an inner threaded collar fixedly connected with a middle head. 6 .6.根据权利要求1所述的安全心包穿刺装置，其特征在于：所述弹簧长≥2.5-3.5cm。6 . The safety pericardiocentesis device according to claim 1 , wherein the length of the spring is greater than or equal to 2.5-3.5 cm. 7 .7.根据权利要求1所述的安全心包穿刺装置，其特征在于沿着核心管纵轴方向，每隔0.5cm距离设一扇形卡片，共4-6个扇形卡片。7 . The safe pericardiocentesis device according to claim 1 , wherein along the longitudinal axis of the core tube, a fan-shaped card is set at every 0.5 cm distance, 4-6 fan-shaped cards in total. 8 .8.权利要求1所述安全心包穿刺装置的使用方法，其特征在于：将穿刺针的针座与导丝弹送器的锥头通过螺口接头紧密连接，导丝送入芯杆中央腔，由阀门贯穿核心管和导丝管，再从锥头孔穿过针座贯穿针体抵达针口；推送穿刺针至目标位置时，导丝在导丝弹送器的作用下从侧向针口自动弹出。8. The method of using the safe pericardiocentesis device according to claim 1, characterized in that: the needle seat of the puncture needle and the cone head of the guide wire ejector are tightly connected through a screw joint, and the guide wire is sent into the central cavity of the core rod, The valve passes through the core tube and the guide wire tube, and then from the cone head hole, through the needle seat, through the needle body, and through the needle body to reach the needle port; when the puncture needle is pushed to the target position, the guide wire is guided from the side needle port under the action of the guide wire ejector. pops up automatically.

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