CN102697527B - External sealed rectum mucous membrane attraction biopsy device - Google Patents
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Abstract
外置式密封的直肠黏膜吸引活检器,涉及直肠黏膜吸引活检手术器械制造技术,适用于对直肠黏膜进行活检手术检查,主要由活检刀外套(1),活检刀(2),活检器导管(6),活检刀拉杆(7),密封箍(9),弹性密封套(10)组成,其中弹性密封套(10)套在活检刀拉杆(7)的后部外,由密封箍(9)密封固定在活检器导管(6)的后部。本发明吸引活检器结构简单合理、密封性好,产品的制造成本低,具有良好的经济效益和社会效益。
An external sealed rectal mucosa suction biopsy device relates to the manufacturing technology of rectal mucosa suction biopsy surgical instruments, and is suitable for performing biopsy surgery on rectal mucosa. It mainly consists of a biopsy knife jacket (1), a biopsy knife (2), and a biopsy catheter (6 ), a biopsy knife rod (7), a sealing collar (9), and an elastic sealing sleeve (10), wherein the elastic sealing sleeve (10) is set outside the rear part of the biopsy knife pulling rod (7), and is sealed by the sealing collar (9) Secures to the rear of the biopsy catheter (6). The suction biopsy device of the invention has simple and reasonable structure, good sealing performance, low manufacturing cost and good economic and social benefits.
Description
技术领域 technical field
外置式密封的直肠黏膜吸引活检器,涉及直肠黏膜吸引活检手术器械制造技术,适用于对直肠黏膜进行活检手术检查。The utility model relates to an external sealed rectal mucosa suction biopsy device, which relates to a rectal mucosa suction biopsy surgical instrument manufacturing technology, and is suitable for performing biopsy surgical examination on the rectal mucosa.
技术背景 technical background
医学临床中有许多肠道疾病需通过活组织的病理组织学观察才能确诊,单就儿童常见的先天性巨结肠及其类源病而言,切取直肠黏膜进行诊断是是否患病的诊断金标准,已成为公认的临床常规性项目。切取直肠黏膜组织最常用、安全、有效的方法是负压吸引活检法。黏膜吸引活检器械在国外已运用了近半个世纪,是医学临床常用的器械。多年来,我国有些厂家和专家共同研发了几种肠黏膜组织吸引活检钳,但终因多种技术障碍,产品的价格高、寿命短、维修难而先后停产。而国外产品销往国内,其产品价格更加昂贵,严重影响了我国这项常规检测的开展。In clinical medicine, many intestinal diseases can only be diagnosed through the histopathological observation of living tissue. As far as the common congenital Hirschsprung’s disease and its related diseases are concerned, the diagnosis of the disease by excising the rectal mucosa is the gold standard for diagnosis , has become a recognized clinical routine project. The most commonly used, safe and effective method for cutting rectal mucosal tissue is negative pressure biopsy. Mucosa suction biopsy instrument has been used in foreign countries for nearly half a century, and it is a commonly used instrument in clinical medicine. Over the years, some manufacturers and experts in my country have jointly developed several kinds of intestinal mucosal tissue suction biopsy forceps, but due to various technical obstacles, high product prices, short lifespan, and difficult maintenance, the production has been discontinued successively. However, foreign products are sold domestically, and their product prices are more expensive, which seriously affects the development of this routine test in our country.
现有黏膜吸引活检器械的工作原理是:直肠黏膜组织吸引活检器械头端为子弹头状的活检刀外套,侧壁有小园孔,外套内置圆筒状活检刀。工作时通过负压将肠管黏膜组织吸入活检刀外套的侧壁孔内,后拉活检刀即可切下吸入的黏膜组织,将外套拆卸下便可取出组织标本后送病理学检查。其基本构造分三部分:一是负压产生和密封维持系统,包括产生负压的设备(常用医用注射器,通过橡胶管与活检器械的抽气口连接)、活检器械的密封部件(常将连接活检刀的拉杆穿过密封橡胶垫片的中心,密封橡胶垫片与拉杆紧密接触,以达到隔绝空气的效果,);二是可拆卸活检刀头,包括头套和内置刀片;三是后拉活检刀的传动机构,包括活检刀片拉杆、发力手柄(手枪柄式或剪刀柄式)以及与活检刀拉杆连接的动力传动部件。实际操作时操作者一手持导杆将活检刀头送入直肠内,将有侧孔的一侧紧贴直肠壁,另一手持器械手柄,操作者的助手将已与活检器械连接的注射器芯后拉,造成负压并维持,此时部分直肠黏膜组织被吸入刀头的侧孔内,操作者快速捏动手柄,将吸入的黏膜组织切下;然后卸下刀头,在活检刀片附近收集黏膜组织标本,送病理组织学检查。The working principle of the existing mucosal suction biopsy instrument is: rectal mucosal tissue suction biopsy instrument head end is the bullet-shaped biopsy knife coat, and side wall has small garden hole, and the cylindrical biopsy knife of coat is built-in. During work, the intestinal mucosal tissue is sucked into the side wall hole of the biopsy knife jacket through negative pressure, and the sucked mucosal tissue can be cut off by pulling the biopsy knife, and the tissue sample can be taken out after the jacket is removed and sent for pathological examination. Its basic structure is divided into three parts: one is negative pressure generation and sealing maintenance system, including negative pressure generating equipment (commonly used medical syringes, connected to the suction port of biopsy instruments through rubber tubes), sealing parts of biopsy instruments (often connected to biopsy The pull rod of the knife passes through the center of the sealing rubber gasket, and the sealing rubber gasket is in close contact with the pull rod to achieve the effect of isolating the air,); the second is the detachable biopsy head, including the head cover and the built-in blade; the third is the back-pull biopsy knife The transmission mechanism includes the biopsy blade pull rod, the force handle (pistol handle type or scissor handle type) and the power transmission parts connected with the biopsy knife pull rod. During the actual operation, the operator holds the guide rod in one hand to send the biopsy knife head into the rectum, puts the side with the side hole close to the rectal wall, and holds the instrument handle in the other hand. The operator's assistant pushes the syringe core connected to the biopsy instrument back At this time, part of the rectal mucosal tissue is sucked into the side hole of the knife head, and the operator quickly pinches the handle to cut off the suctioned mucosal tissue; then remove the knife head, and collect the mucosa near the biopsy blade Tissue samples were sent for histopathological examination.
现有这类器械的缺点:近年来这类器械虽有所改进,但主要体现在活检刀头部分,将活检刀头改为一次性部件,以保证刀片锋利,减少病人间的互相污染,但器械本身的价格逾万元人民币,单单一枚一次性塑料刀头的价格就在人民币300元。而国产的同类产品,由于器械设计复杂,制造技术要求高,价格在人民币4000元以上,产品在反复使用和高温消毒后,部件易老化和磨损,负压密封维持系统中的密封垫圈常易出现漏气障碍,需反复维修或致整个器械报废,这也使得国产吸引活检器械难以得到推广。The shortcoming of existing this kind of equipment: Although this kind of equipment has been improved in recent years, it is mainly reflected in the biopsy cutter head part, and the biopsy cutter head is changed into a disposable part to ensure that the blade is sharp and reduce the mutual contamination between patients. The price of the device itself is more than 10,000 yuan, and the price of a single disposable plastic knife head is 300 yuan. However, similar domestic products, due to the complex design of the device and high manufacturing technology requirements, cost more than RMB 4,000. After repeated use and high-temperature sterilization, the components are prone to aging and wear, and the sealing gaskets in the negative pressure seal maintenance system are often prone to damage. Leakage barriers require repeated repairs or the entire device is scrapped, which also makes it difficult to promote domestic biopsy devices.
发明内容 Contents of the invention
针对现有黏膜吸引活检器械的不足,本发明人经过长期研究,提供一种结构简单、密封性好,产品制造成本低,采用外置式密封的直肠黏膜吸引活检器。Aiming at the shortcomings of existing mucosal suction biopsy devices, the inventors have provided a rectal mucosa suction biopsy device with simple structure, good sealing performance, low product manufacturing cost and external sealing after long-term research.
本发明吸引活检器主要由活检刀外套,活检刀,活检器导管,活检刀拉杆,密封箍,弹性密封套组成,整个吸引活检器成直管形。活检刀外套的一侧置有活检孔,活检刀外套通过螺纹密封固定在活检器导管前部,活检刀外套和活检器导管采用医用塑料或不锈钢材料制成。活检刀设置在活检刀外套内,与设在活检器导管内的活检刀拉杆前部固定连接,在活检刀拉杆的后端置有膨大状的手捏柄,以便于操作人员捏紧手捏柄,快速拉动活检刀。弹性密封套套在活检刀拉杆后部外,并由密封箍密封固定在吸引活检器导管的后部。密封弹性套采用具有良好延伸性的材料制成。本发明吸引活检器通过橡胶管与负压产生及维持设备连通,工作时通过负压产生及维持设备使吸引活检器内产生负压并维持负压状态。The suction biopsy device of the present invention is mainly composed of a biopsy knife jacket, a biopsy knife, a biopsy device catheter, a biopsy knife pull rod, a sealing hoop, and an elastic sealing sleeve, and the whole suction biopsy device is in the shape of a straight tube. One side of the biopsy knife overcoat is provided with a biopsy hole, and the biopsy knife overcoat is fixed on the front part of the biopsy catheter by thread sealing, and the biopsy knife overcoat and the biopsy catheter are made of medical plastic or stainless steel. The biopsy knife is set in the biopsy knife jacket, and is fixedly connected with the front part of the biopsy knife pull rod in the biopsy catheter, and an enlarged hand handle is placed at the rear end of the biopsy knife pull rod, so that the operator can squeeze the handle tightly , quickly pull the biopsy knife. The elastic sealing sleeve is sheathed outside the rear part of the biopsy knife pull rod, and is sealed and fixed on the rear part of the suction biopsy device catheter by a sealing hoop. The sealing elastic sleeve is made of a material with good extensibility. The suction biopsy device of the present invention communicates with the negative pressure generating and maintaining equipment through the rubber tube, and generates negative pressure in the suction biopsy device and maintains the negative pressure state through the negative pressure generating and maintaining equipment during operation.
本发明吸引活检器的优点在于:The advantage of the present invention attracts biopsy device is:
1.采用弹性密封套密封固定在活检器导管后部的外置式密封方式,改变了现有采用密封垫圈的内置式密封方式,具有良好的密封性,避免了由于密封垫圈老化和磨损而造成黏膜吸引活检器械漏气,导致活检手术的失败。1. The external sealing method, which is sealed and fixed at the rear of the biopsy catheter by an elastic sealing sleeve, has changed the existing built-in sealing method using sealing gaskets. It has good sealing performance and avoids the aging and wear of sealing gaskets. Suction biopsy instrument leaks, leading to failure of biopsy surgery.
2.采用弹性密封套外置式密封方式,手术时活检刀拉杆的活动始终在稳定的负压状态下进行,避免了手术过程中为维持负压的稳定,要不断地对负压产生和维持设备进行操作,有效保证了活检手术的顺利进行,能够很好的满足临床实际需要。2. With the external sealing method of the elastic sealing sleeve, the movement of the biopsy knife rod is always carried out under a stable negative pressure state during the operation, which avoids the need to continuously generate and maintain the negative pressure in order to maintain the stability of the negative pressure during the operation. The operation can effectively ensure the smooth progress of the biopsy operation and can well meet the actual clinical needs.
3.本发明吸引活检器舍弃了现有吸引活检器械的操作手柄以及传动部件,大大简化了吸引活检器的结构,使吸引活检器的外形为便于手术和携带的直管形,不仅有效降低了产品的制造成本,且具有良好的经济效益和社会效益。3. The suction biopsy device of the present invention abandons the operating handle and transmission parts of the existing suction biopsy instrument, greatly simplifies the structure of the suction biopsy device, and makes the shape of the suction biopsy device a straight tube shape that is convenient for operation and carrying, which not only effectively reduces the The manufacturing cost of the product has good economic and social benefits.
附图说明 Description of drawings
附图是本发明实施例示意图,Accompanying drawing is the schematic diagram of embodiment of the present invention,
图1是本发明吸引活检器示意图,Fig. 1 is a schematic diagram of the suction biopsy device of the present invention,
图2是本发明吸引活检器结构示意图。Fig. 2 is a schematic structural diagram of the suction biopsy device of the present invention.
其中:活检刀外套1,活检刀2,活检孔3,连接凸缘4,密封垫圈5,活检器导管6,活检刀拉杆7,负压连接管8,密封箍9,弹性密封套10,手捏柄11。Among them:
具体实施方式 Detailed ways
结合附图对本发明作进一步描述:The present invention will be further described in conjunction with accompanying drawing:
本发明吸引活检器由活检刀外套1,活检刀2,活检孔3,连接凸缘4,密封垫圈5,活检器导管6,活检刀拉杆7,负压连接管8,密封箍9,弹性密封套10,手捏柄11组成,为直管形吸引活检器。活检刀外套1的一侧置有活检孔3,密封垫圈5设置在活检器导管6前部的连接凸缘4上,在活检刀外套1的底部通过螺纹与活检器导管6前部的连接凸缘4固定连接后,密封垫圈5防止连接部位负压泄漏。活检刀外套1和活检器导管6采用医用塑料或不锈钢材料制成。活检刀2设置在活检刀外套1内,与设在活检器导管6内的活检刀拉杆7的前部固定连接,在活检刀拉杆7的后端置有圆环状的手捏柄11,以便于操作人员捏紧手捏柄11拉动活检刀2,弹性密封套10套在活检刀拉杆7的后部外,由密封箍9密封固定在活检器导管6的后部。负压连接管8密封固定在吸引活检器的后部,通过橡胶管与负压产生及维持设备连通,通过负压产生及维持设备使本发明吸引活检器内产生负压并维持负压状态。本发明吸引活检器工作时,通过负压将直肠管黏膜组织吸入活检刀外套1的活检孔3内,此时弹性密封套10呈扁瘪状,操作人员隔着弹性密封套10拉动活检刀2切下吸入活检孔3内的直肠管黏膜组织。从直肠内取出吸引活检器后,卸下活检刀外套1,拆卸下活检刀2,取出肠管黏膜组织标本后送病理学检查。The suction biopsy device of the present invention consists of a
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CA2899734A1 (en) * | 2013-03-15 | 2014-09-25 | Devicor Medical Products, Inc. | Biopsy device |
CN111603215B (en) * | 2020-06-04 | 2023-03-10 | 李朝阳 | Rectum mucous membrane columnar folding suturing device |
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CN2684767Y (en) * | 2003-11-06 | 2005-03-16 | 李民驹 | Double-hole rectal mucosa suction biopsy apparatus |
CN201524094U (en) * | 2009-08-28 | 2010-07-14 | 许瑞云 | Sample collector |
DE102009053341B3 (en) * | 2009-11-17 | 2011-07-28 | Dittmann, Ludwig, 14163 | Vaginal fluid testing device for treating bacterial vaginosis of women, has fluid receiving zone in mechanical contact with projection of cover in diagnostic position, where projection is impregnated with dry potassium hydroxide |
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CN2684767Y (en) * | 2003-11-06 | 2005-03-16 | 李民驹 | Double-hole rectal mucosa suction biopsy apparatus |
CN201524094U (en) * | 2009-08-28 | 2010-07-14 | 许瑞云 | Sample collector |
DE102009053341B3 (en) * | 2009-11-17 | 2011-07-28 | Dittmann, Ludwig, 14163 | Vaginal fluid testing device for treating bacterial vaginosis of women, has fluid receiving zone in mechanical contact with projection of cover in diagnostic position, where projection is impregnated with dry potassium hydroxide |
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