CN101703416A - Bile duct puncturing needle - Google Patents
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Abstract
本发明公开了一种胆管穿刺针,包括注射部分和导向部分,所述注射部分包括鲁尔接头和导流管,导流管的近端与鲁尔接头连接,导流管的远端设置针管;所述导向部分包括空套在导流管外面的导向管,导向管的近端连接用于手持的导向部件,导向管的远端可遮蔽导流管的远端;所述导流管内穿设有导丝,导丝的近端穿出鲁尔接头,导丝的远端可穿出针管;其中,所述导向管和导流管均为软管,所述针管为具有穿刺针尖的金属管。本技术方案可实现直接穿刺胆管将导丝放入胆管,避免经过十二指肠壶腹引发胰腺炎。
The invention discloses a bile duct puncture needle, which comprises an injection part and a guide part. The injection part includes a Luer connector and a diversion tube. The proximal end of the diversion tube is connected with the Luer connector, and a needle tube is arranged at the far end of the diversion tube. ; The guide part includes a guide tube that is emptied outside the guide tube, the proximal end of the guide tube is connected to a hand-held guide component, and the far end of the guide tube can cover the far end of the guide tube; A guide wire is provided, the proximal end of the guide wire passes through the Luer connector, and the distal end of the guide wire can pass through the needle tube; wherein, the guide tube and the flow guide tube are both flexible tubes, and the needle tube is made of metal with a puncture needle point Tube. The technical scheme can realize the direct puncture of the bile duct and put the guide wire into the bile duct, so as to avoid pancreatitis caused by passing through the ampulla of the duodenum.
Description
技术领域technical field
本发明属于一种医疗器械,特别涉及一种十二指肠内窥镜下手术用的胆道穿刺针,又称龚式针。The invention belongs to a medical device, in particular to a biliary tract puncture needle for duodenal endoscopic surgery, also known as a Gong-type needle.
背景技术Background technique
随着科技水平的提高和人文医学的发展,微创伤的概念越来越多地被应用在临床上。如何使用尽可能小的创伤来达到医生的治疗目的,便成为目前经常涉及到的话题。就消化系统中的难点——胰胆管系统疾病而言,其微创技术日臻成熟,已涉及到诊断、治疗各个方面。With the improvement of science and technology and the development of humanistic medicine, the concept of microtrauma is increasingly being applied clinically. How to use as little trauma as possible to achieve the doctor's treatment purpose has become a topic that is often involved. As far as the difficult point in the digestive system—pancreaticobiliary system disease is concerned, its minimally invasive technology is becoming more and more mature, and it has been involved in various aspects of diagnosis and treatment.
胆道或胰管系统疾病在我国是一种临床常见病,尤其是随着生活节奏的加快,此类病况日益凸显出来,以往多采用手术治疗,但存在创伤大,并发症多和容易复发的缺点,许多患者因结石复发而接受多次的手术治疗,身心受到巨大的伤害。随着临床内镜技术的发展,经内镜逆行胆胰管造影术来实现胆总管取石等在临床得到广泛应用。Biliary tract or pancreatic duct system disease is a common clinical disease in our country, especially with the acceleration of the pace of life, this kind of disease has become more and more prominent. In the past, surgery was often used for treatment, but it has the disadvantages of large trauma, many complications and easy recurrence. , Many patients have received multiple surgical treatments due to recurrence of stones, causing great physical and mental damage. With the development of clinical endoscopic technology, endoscopic retrograde cholangiopancreatography to remove common bile duct stones has been widely used in clinic.
内镜下逆行胰胆管造影术,英文简称ERCP,通过十二指肠镜对胰胆管逆行造影从而对相关疾病进行诊断和治疗的一项技术。对于胆系结石、肿瘤、损伤、狭窄、畸形等有重要诊断价值。此项目检查有比B超、CT等影像学检查更为直观的图象。该手术使用的系列附件器械,通常包括:导丝、切开刀、取石球囊、扩张球囊、取石网篮、造影导管、塑料支架和金属支架等。其他典型的适应症还有诸如:原因不明的阻塞性黄疸疑有肝外胆道梗阻者;疑有各种胆道疾病如结石、肿瘤、硬化性胆管炎等诊断不明者;疑有先天性胆道异常或胆囊术后症状再发者;胰腺疾病:胰腺肿瘤、慢性胰腺炎、胰腺囊肿等。Endoscopic retrograde cholangiopancreatography, abbreviated as ERCP, is a technique for diagnosing and treating related diseases by performing retrograde imaging of the pancreas and cholangiopancreatography through a duodenoscope. It has important diagnostic value for gallstones, tumors, injuries, strictures, and deformities. This project has more intuitive images than B-ultrasound, CT and other imaging examinations. A series of accessory instruments used in this operation usually include: guide wire, incision knife, stone removal balloon, expansion balloon, stone removal mesh basket, contrast catheter, plastic stent and metal stent, etc. Other typical indications include: unexplained obstructive jaundice with suspected extrahepatic biliary obstruction; suspected various biliary diseases such as stones, tumors, sclerosing cholangitis, etc.; suspected congenital biliary abnormalities or Patients with recurrence of symptoms after cholecystectomy; pancreatic diseases: pancreatic tumors, chronic pancreatitis, pancreatic cysts, etc.
内镜下逆行胰胆管造影术,因为其对象在人体的特殊位置——胰胆管系统,在国内属于比较复杂,难度大的手术,由于胰胆管系统特殊的生理位置,位置狭窄且在内窥镜下不可直视。致使常规的胃肠消化系统的器械不可直接应用到胰胆管系统。常规手术过程都是通过对十二指肠乳头插管造影,通入导丝来作相关治疗,这样往往会带来胰腺炎并发症。Endoscopic retrograde cholangiopancreatography, because its object is in the special position of the human body—the pancreaticobiliary system, is a relatively complicated and difficult operation in China. Due to the special physiological position of the pancreaticobiliary system, the position is narrow and the endoscopic Do not look straight down. As a result, conventional gastrointestinal digestive system devices cannot be directly applied to the pancreaticobiliary system. Routine operation process is all through duodenal papilla intubation angiography, passes through guide wire to do relevant treatment, often will bring pancreatitis complication like this.
如图1所示,现有手术过程是通过以下步骤实现:As shown in Figure 1, the existing surgical procedure is realized through the following steps:
1)术前准备;1) Preoperative preparation;
2)插入十二指肠内窥镜,寻找十二指肠乳头位置;2) Insert a duodenoscope to find the position of the duodenal nipple;
3)经十二指肠内窥镜钳道插入导丝,寻找进入十二指肠乳头及胆管或胰管等预期位置。3) Insert the guide wire through the clamp channel of the duodenoscope, and search for the expected positions such as the duodenal papilla, bile duct or pancreatic duct.
上述操作过程,目前在临床应用比较普遍,但有一缺陷就是往往会带来胰腺炎并发症的发生。其临床表现通常为:术后血淀粉酶升高超过500索氏单位,出现的中上腹部痛持续性24h以上。腹痛伴恶心、呕吐,左上腹部压痛,伴或不伴有肌紧张。腹部B超及CT检查可见胰腺明显肿大、周围水肿明显、间隙消失、粘连、胰腺实质内可见点泡状液化坏死腔。The above-mentioned operation process is relatively common in clinical application at present, but one defect is that it often leads to the occurrence of pancreatitis complications. Its clinical manifestations are usually: postoperative blood amylase rises more than 500 Soxhlet units, and upper and middle abdominal pain persists for more than 24 hours. Abdominal pain with nausea, vomiting, left upper quadrant tenderness, with or without muscle tension. Abdominal B-ultrasound and CT examination showed that the pancreas was obviously enlarged, the surrounding edema was obvious, the gap disappeared, adhesions, and bubbly liquefied necrotic cavities could be seen in the pancreatic parenchyma.
临床上已经使用的一种穿刺硬化针,主要是通过内窥镜钳道进入消化道或肠胃道,对胃肠黏膜进行注射,通过内镜导入硬化或止血药物到选定区域对消化系统现有出血或潜在出血点进行控制,用于内镜黏膜检查术及息肉切除术后生理盐水的注射的医疗器械.临床适应症多为:针对消化道出血的止血;静脉曲张的硬化处理;病体组织染色技术;以及其他用途的人体腔道内壁注射药物等等.目前此器械在临床应用比较普遍,全国每年做硬化注射的病例达几百万人次.A puncture hardening needle that has been used clinically, mainly enters the digestive tract or gastrointestinal tract through the endoscope forceps, injects the gastrointestinal mucosa, and introduces hardening or hemostatic drugs into the selected area through the endoscope to treat the existing digestive system. Bleeding or potential bleeding points are controlled, and it is used as a medical device for the injection of normal saline after endoscopic mucosal examination and polypectomy. Most of the clinical indications are: hemostasis for gastrointestinal bleeding; sclerotherapy of varicose veins; staining of diseased tissues technology; and other purposes of injecting drugs into the inner wall of the human cavity, etc. At present, this device is widely used in clinical practice, and there are millions of cases of sclerosing injections in the country every year.
发明内容Contents of the invention
为解决上述的技术问题,本发明的目的是提供一种胆管穿刺针,可实现直接穿刺胆管将导丝放入胆管,避免经过十二指肠壶腹引发胰腺炎。In order to solve the above-mentioned technical problems, the purpose of the present invention is to provide a bile duct puncture needle, which can directly puncture the bile duct and put the guide wire into the bile duct, so as to avoid pancreatitis caused by passing through the ampulla of the duodenum.
为达到上述目的,本发明采用了以下的技术方案:To achieve the above object, the present invention adopts the following technical solutions:
一种胆管穿刺针,包括注射部分和导向部分,所述注射部分包括鲁尔接头和导流管,导流管的近端与鲁尔接头连接,导流管的远端设置针管;所述导向部分包括空套在导流管外面的导向管,导向管的近端连接用于手持的导向部件,导向管的远端可遮蔽导流管的远端;所述导流管内穿设有导丝,导丝的近端穿出鲁尔接头,导丝的远端可穿出针管;其中,所述导向管和导流管均为软管,所述针管为具有穿刺针尖的金属管。A biliary puncture needle, comprising an injection part and a guide part, the injection part includes a Luer connector and a guide tube, the proximal end of the guide tube is connected to the Luer connector, and a needle tube is arranged at the far end of the guide tube; the guide Part of it includes a guide tube that is sheathed outside the guide tube, the proximal end of the guide tube is connected to a hand-held guide component, and the distal end of the guide tube can cover the distal end of the guide tube; a guide wire is threaded inside the guide tube , the proximal end of the guide wire passes through the Luer connector, and the distal end of the guide wire can pass through the needle tube; wherein, both the guide tube and the flow guide tube are flexible tubes, and the needle tube is a metal tube with a puncture needle point.
作为优选,上述鲁尔接头前端固接有金属导管,金属导管前端连接导流管,所述导向部件空套在金属导管上,导向部件前端固接有金属连接管,金属连接管上套接固定导向管的近端。采用金属导管导向部件调整更加方便,采用金属连接管方便安装。As a preference, the front end of the Luer connector is fixedly connected with a metal conduit, the front end of the metal conduit is connected to the diversion tube, the guide part is vacantly sleeved on the metal conduit, the front end of the guide part is fixedly connected with a metal connecting tube, and the metal connecting tube is sleeved and fixed. the proximal end of the guide tube. It is more convenient to adjust by using metal conduit guide parts, and it is convenient to install by using metal connecting pipes.
作为优选,上述鲁尔接头和导向部件之间的金属导管上空套有调整部件,调整部件与导向部件螺纹连接。上述调整部件一端与导向部件螺纹连接,另一端可通过扣位结构与鲁尔接头连接。设置调整部件可以调整针管的伸出长度,方便医生操作。Preferably, an adjustment component is sheathed on the metal conduit between the Luer connector and the guide component, and the adjustment component is threadedly connected to the guide component. One end of the adjustment component is threadedly connected to the guide component, and the other end can be connected to the Luer connector through a buckle structure. Setting the adjusting part can adjust the protruding length of the needle tube, which is convenient for doctors to operate.
作为优选,上述鲁尔接头和调整部件之间设有限制两者间距的限位部件。限位部件可以防止在包装运输过程中,针管露出外鞘刺破包装袋,导致产品包装损坏。Preferably, a limiting component is provided between the above-mentioned Luer connector and the adjusting component to limit the distance between the two. The limiting part can prevent the outer sheath of the needle tube from piercing the packaging bag during packaging and transportation, resulting in damage to the product packaging.
上述针管通过套接管固定在导流管的远端。针管穿设在导流管远端,导流管远端外面通过套接管箍套锁紧固定,这样方便加工连接可靠。The above-mentioned needle tube is fixed on the far end of the guide tube through the socket tube. The needle tube is passed through the distal end of the diversion tube, and the outer surface of the distal end of the diversion tube is locked and fixed by a sleeve, which is convenient for processing and reliable connection.
上述导向管上套设有保护套管。The guide tube is covered with a protective sleeve.
本发明由于采用了以上技术方案,可实现直接穿刺胆管将导丝放入胆管,进行后面的手术治疗操作,避免经过十二指肠壶腹引发的胰腺炎。Due to the adoption of the above technical scheme, the present invention can directly puncture the bile duct and put the guide wire into the bile duct for subsequent surgical treatment operations, avoiding pancreatitis caused by passing through the ampulla of the duodenum.
附图说明Description of drawings
图1:现有的胰胆管系统临床手术应用示意图;Figure 1: Schematic diagram of the existing clinical operation of the pancreaticobiliary system;
图2:本发明的胰胆管系统临床手术应用示意图;Fig. 2: Schematic diagram of clinical operation application of pancreaticobiliary system of the present invention;
图3:本发明的结构示意图;Fig. 3: structural representation of the present invention;
图4:图3中的I处局部放大图;Figure 4: Partial enlarged view of I in Figure 3;
图5:图3中的II处局部放大图;Figure 5: Partial enlarged view of II in Figure 3;
具体实施方式Detailed ways
下面结合附图对本发明的具体实施方式做一个详细的说明。The specific implementation manner of the present invention will be described in detail below in conjunction with the accompanying drawings.
实施例1:Example 1:
如图3~图5所示的一种胆管穿刺针,包括注射部分和导向部分,所述注射部分包括鲁尔接头2和导流管11,导流管11的近端与鲁尔接头2连接,导流管11的远端设置针管9;所述导向部分包括空套在导流管11外面的导向管8,导向管8的近端连接用于手持的导向部件6,导向管8的远端可遮蔽导流管11的远端;所述导流管11内穿设有导丝1,导丝1的近端穿出鲁尔接头2,导丝1的远端可穿出针管9;其中,所述导向管8和导流管11均为软管,所述针管9为具有穿刺针尖的金属管.A bile duct puncture needle as shown in Figures 3 to 5, including an injection part and a guide part, the injection part includes a Luer connector 2 and a
本实施例中,所述鲁尔接头2前端固接有金属导管4,金属导管4前端连接导流管11,所述导向部件6空套在金属导管4上,导向部件6前端固接有金属连接管10,金属连接管10上套接固定导向管8的近端;所述鲁尔接头2和导向部件6之间的金属导管4上空套有调整部件5,调整部件5与导向部件6螺纹连接。所述调整部件5一端与导向部件螺纹连接,另一端可通过扣位结构与鲁尔接头2连接。所述鲁尔接头2和调整部件5之间的金属导管4上夹持设有限制上述两者间距的限位部件3。所述针管9通过套接管12固定在导流管11的远端。所述导向管8的近端上套设有保护套管7用于保护金属管与柔性管的连接处。In this embodiment, the front end of the Luer connector 2 is fixedly connected with a
所述鲁尔接头为连接注射器的快速接头,本实施例选用6%内圆锥鲁尔接头可与注射器配合使用;各种规格的针管可穿刺黏膜组织,其整体内腔为药物通道,用于导入需注射的药物,主要材料为医用级ABS、医用级不锈钢。龚式针是通过内窥镜的钳道到达人体预期位置。它具备不同的针管材料,针管规格和长度也根据临床需要进行选择。所有零件都是以导丝的外径尺寸为依据设计相关的接口尺寸,保证导丝能顺利通过,并能注射物质。The Luer connector is a quick connector for connecting the syringe. In this embodiment, a 6% inner conical Luer connector can be used in conjunction with the syringe; needle tubes of various specifications can puncture mucosal tissues, and the overall lumen is a drug channel for introducing Drugs to be injected are mainly made of medical grade ABS and medical grade stainless steel. The Gong-style needle reaches the expected position of the human body through the clamp channel of the endoscope. It has different needle tube materials, and the specifications and length of the needle tube are also selected according to clinical needs. All parts are based on the outer diameter of the guide wire to design the relevant interface size to ensure that the guide wire can pass through smoothly and the substance can be injected.
如图2所示,本发明的手术步骤如下:As shown in Figure 2, the operation steps of the present invention are as follows:
1)术前准备;1) Preoperative preparation;
2)插入十二指肠内窥镜,寻找进入十二指肠降段位置。2) Insert the duodenoscope, and look for the position where it enters the descending part of the duodenum.
3)经十二指肠内窥镜钳道插入本器械龚式针,找到降段乳头位置,将导向管8对准胆管壁。握住导向部件6,取掉限位部件3,将导丝1后抽到远端不可见,将鲁尔接头2和调节部件5扣位连接,顺时针旋转调节部件5,则其将带着鲁尔接头2所在注射部分一起向远端移动,注射部分远端所在的针管9将逐渐露出导向管8,刺入胆管。反之,逆时针旋转调节部件5,则其将带着鲁尔接头2所在注射部分一起向近端移动,注射部分远端所在的针管9将逐渐回缩进导向管8;3) Insert the Gong-style needle of this instrument through the forceps channel of the duodenoscope, find the position of the nipple in the descending segment, and align the
4)推进导丝1通过针管9推入胆管(在X线屏幕上确认已进入胆管);4) Push the
5)保留导丝1不动,其他部分都抽出内窥镜;5) Keep the
6)导丝进入胆管后,其他ERCP器械可沿导丝进入,进行相关手术操作。6) After the guide wire enters the bile duct, other ERCP instruments can enter along the guide wire to perform related operations.
内窥镜下,导丝器械进入胰胆管系统,诊断后需要注射药物时,将注射部分的远端(针管)从导丝的末端穿入,沿着导丝直到预期位置,再行药物注射,实现治疗目的。Under the endoscope, the guide wire device enters the pancreaticobiliary system, and when it is necessary to inject drugs after diagnosis, the distal end of the injection part (needle) is penetrated from the end of the guide wire, along the guide wire to the expected position, and then the drug is injected. achieve the purpose of treatment.
上述实施例用来解释说明本发明,而不是对本发明进行限制,在本发明的精神和权利要求的保护范围内,对本发明作出的任何修改和改变,都落入本发明的保护范围。The above-mentioned embodiments are used to illustrate the present invention, rather than to limit the present invention. Within the spirit of the present invention and the protection scope of the claims, any modification and change made to the present invention will fall into the protection scope of the present invention.
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| CN103520821A (en) * | 2013-10-23 | 2014-01-22 | 乔坤 | Jejunum coloproctia catheterization device used under laparoscope |
| CN103948418A (en) * | 2012-05-03 | 2014-07-30 | 徐舒 | Puncture instrument |
| CN110584852A (en) * | 2018-06-13 | 2019-12-20 | 南京微创医学科技股份有限公司 | Hot puncture support imbedding device |
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2009
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103948418A (en) * | 2012-05-03 | 2014-07-30 | 徐舒 | Puncture instrument |
| CN103520821A (en) * | 2013-10-23 | 2014-01-22 | 乔坤 | Jejunum coloproctia catheterization device used under laparoscope |
| CN110584852A (en) * | 2018-06-13 | 2019-12-20 | 南京微创医学科技股份有限公司 | Hot puncture support imbedding device |
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|---|---|
| CN101703416B (en) | 2011-06-01 |
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