CN211749751U - Tissue biopsy negative pressure cutting device for bile duct stenosis diseases - Google Patents
Tissue biopsy negative pressure cutting device for bile duct stenosis diseases Download PDFInfo
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Abstract
本实用新型涉及医疗器械技术领域,具体涉及一种用于胆管狭窄性疾病的组织活检负压切取装置,包括操作手柄、鲁尔接头、外管、传动丝和切取装置,所述的外管与操作手柄连接,内部设有第一腔和第二腔,传动丝设置于第二腔中;所述的鲁尔接头设置于外管靠近操作手柄的一端,分为第一鲁尔接头和第二鲁尔接头,第一鲁尔接头与第一腔相通,供导丝穿过;第二鲁尔接头与第二腔相通;所述的切取装置中空,末端锋利,可拆卸的设置于传动丝的末端;所述的第二鲁尔接头连接负压装置。本实用新型的可准确的定位病理组织的位置并切取,切取过程简单,对组织的创伤小,储样量大,且在取出的过程中样品不会丢失,得到的样品阳性检出率高,可在临床上推广应用。
The utility model relates to the technical field of medical devices, in particular to a tissue biopsy negative pressure cutting device for bile duct stenosis diseases, comprising an operating handle, a Luer connector, an outer tube, a transmission wire and a cutting device, wherein the outer tube and The operation handle is connected, a first cavity and a second cavity are arranged inside, and the transmission wire is arranged in the second cavity; the luer joint is arranged at one end of the outer tube close to the operation handle, and is divided into a first luer joint and a second luer joint. A luer connector, the first luer connector communicates with the first cavity for the guide wire to pass through; the second luer connector communicates with the second cavity; the cutting device is hollow, with a sharp end, and is detachably arranged on the transmission wire. The end; the second luer connector is connected to the negative pressure device. The utility model can accurately locate the position of the pathological tissue and cut it, the cutting process is simple, the trauma to the tissue is small, the storage volume is large, the sample will not be lost during the process of taking out, and the obtained sample has a high positive detection rate. It can be applied in clinical practice.
Description
技术领域technical field
本实用新型涉及医疗器械技术领域,具体涉及一种用于胆管狭窄性疾病的组织活检负压切取装置。The utility model relates to the technical field of medical devices, in particular to a tissue biopsy negative pressure cutting device for bile duct stricture diseases.
背景技术Background technique
胆道狭窄是临床常见疾病,其由良性狭窄或恶性肿瘤引起,良性胆管狭窄是由于胆管损伤或胆管炎性改变所致,亦或者是胆道术后导致的胆管腔瘢痕性缩窄,恶性胆管狭窄主要由肿瘤压迫所致。胆道狭窄良恶性质的判断对患者治疗方式的选择和疾病预后十分重要,但临床鉴别诊断十分困难,尤其是恶性胆道狭窄,由于早期症状不典型,患者出现明显临床表现时已属中晚期,根治性手术切除率和生存率低,预后极差。Biliary stricture is a common clinical disease, which is caused by benign stricture or malignant tumor. Benign bile duct stricture is caused by bile duct injury or bile duct inflammatory changes, or is caused by cicatricial narrowing of the bile duct lumen after biliary surgery. Malignant bile duct stricture is mainly caused by Caused by tumor compression. The judgment of the benign and malignant nature of biliary stricture is very important for the selection of treatment methods and the prognosis of the disease, but the clinical differential diagnosis is very difficult, especially for malignant biliary stricture. The surgical resection rate and survival rate are low, and the prognosis is very poor.
经内镜逆行性胰胆管造影术(ERCP)是胰胆系统疾病诊断及治疗的重要手段。ERCP可显示肝内外胆管全貌,但对胆管狭窄定性诊断的敏感性、特异性及准确性不够高;十二指肠镜下胆管腔内超声(IDUS)可直接在胆管内进行超声,更贴近病变组织,但仍属于影像学诊断,不能获取病理依据。Endoscopic retrograde cholangiopancreatography (ERCP) is an important method for the diagnosis and treatment of pancreaticobiliary diseases. ERCP can display the whole picture of intrahepatic and extrahepatic bile ducts, but its sensitivity, specificity and accuracy are not high enough for the qualitative diagnosis of bile duct strictures. Duodenoscope intraluminal ultrasonography (IDUS) can perform ultrasound directly in the bile duct, which is closer to the lesions. tissue, but it still belongs to the imaging diagnosis and cannot obtain the pathological basis.
目前,胆管狭窄性疾病的病理组织学检查方法主要有ERCP下细胞刷检、胆汁引流细胞学检查和活检钳检查等。ERCP下细胞刷检、胆汁引流细胞学检查只能取得细胞学样品,阳性率较低(只有20-30%),准确性差,对于临床诊断有很大的局限性;活检钳检查是通过内窥镜进入人体的病灶处,对病变的组织进行取样,然后通过对病变组织的检测来判断病情的一种方法,准确性高,但其对患者的创伤大,样品的取样量少,且有可能在取出的过程中丢失样品组织,造成更大的创伤。其它方法如经口子母胆道镜费用高昂、操作费时、镜身脆弱易损,经皮经肝穿刺胆道活检创伤性大、操作困难、且有胆道出血及穿孔、易于肿瘤播散等风险,导致临床应用受到限制。现有临床治疗过程中,始终没有一种取样位置精准,取样量大,且对患者的创伤小的活检取样装置。At present, the histopathological examination methods for bile duct stricture diseases mainly include cytological brushing under ERCP, bile drainage cytology and biopsy forceps examination. Cytological brushing and bile drainage cytology under ERCP can only obtain cytological samples, the positive rate is low (only 20-30%), the accuracy is poor, and it has great limitations for clinical diagnosis; biopsy forceps examination is performed by endoscopy It is a method in which the microscope enters the lesion of the human body, samples the lesion tissue, and then judges the disease condition by detecting the lesion tissue. Loss of sample tissue during removal causes more trauma. Other methods such as transoral choledochoscopy are expensive, time-consuming to operate, fragile and fragile, and percutaneous transhepatic biliary biopsy is invasive, difficult to operate, and has risks of biliary bleeding and perforation, and easy tumor dissemination. Apps are restricted. In the existing clinical treatment process, there is no biopsy sampling device with accurate sampling position, large sampling volume, and less trauma to the patient.
虽然实用新型专利“附带导丝通道的活检钳”(201620656702.X)公开了一种附带导丝通道的活检钳,可以快速高效的去除胰胆管支架且可以进入胰胆管病变处活检取样。发明人对该设备进行了全面的研究,发现其通过鳄齿形的钳头取样,但是由于胆道较长,且各段狭窄程度不一致,该设备还存在以下诸多问题:1.为了避免患者在活检取样过程中受到较大创伤,发生医疗事故,必须保证较小的操作力度,那么鳄齿形的钳头就无法充分接触,进而导致刮取的组织量不够,需要多次取样才能符合要求,实际导致了患者损伤加剧;2.为了保证足够的刮取组织量,必须将鳄齿形的钳头与胆管倾斜呈较大的角度,才能着力取样,但是由于无法精确判断并控制钳头与胆管间的倾斜角度和取样力度,导致取样过程对患者造成巨大创伤,仪器甚至会贯穿胆管,危及患者的生命安全。Although the utility model patent "Biopsy Forceps with a Guide Wire Channel" (201620656702.X) discloses a biopsy forceps with a guide wire channel, it can quickly and efficiently remove the pancreaticobiliary stent and can enter the pancreaticobiliary duct lesions for biopsy sampling. The inventor has conducted a comprehensive research on the device and found that it is sampled through the crocodile-shaped forceps head. However, due to the long bile duct and the inconsistent stenosis of each segment, the device also has the following problems: 1. In order to avoid the patient's biopsy In the process of sampling, if a large trauma occurs and a medical accident occurs, a small operation force must be ensured, then the crocodile-shaped forceps head cannot be fully contacted, resulting in insufficient scraped tissue, and multiple samplings are required to meet the requirements. 2. In order to ensure a sufficient amount of scraped tissue, the crocodile-shaped forceps head and the bile duct must be inclined at a large angle to focus on sampling, but because it is impossible to accurately judge and control the gap between the forceps head and the bile duct Due to the inclination angle and sampling force, the sampling process will cause huge trauma to the patient, and the instrument may even penetrate the bile duct, endangering the life of the patient.
针对上述技术问题,本实用新型公开了一种用于胆管狭窄性疾病的组织活检负压切取装置,相较于现有技术中公开的活检钳,所述的装置取样位置精准,取样量大,且对患者的创伤小。In view of the above technical problems, the utility model discloses a tissue biopsy negative pressure cutting device for bile duct stricture diseases. Compared with the biopsy forceps disclosed in the prior art, the device has a precise sampling position and a large sampling volume. and less trauma to the patient.
发明内容SUMMARY OF THE INVENTION
一种用于胆管狭窄性疾病的组织活检负压切取装置,包括操作手柄、鲁尔接头6、外管7和传动丝9,所述的操作手柄由芯杆1、滑块2和助推杆3组成,所述的芯杆1呈中空杆状,一端设有内螺纹,另一端设有手柄环,侧壁设有开口;助推杆3设置于芯杆1内部,滑块2嵌套在芯杆1上,与芯杆1可相对滑动,所述的滑块2将芯杆1密封;助推杆3一端连接在滑块2上,另一端连接传动丝9;所述的外管7上设有外螺纹,外管7和芯杆1通过螺纹密封连接;所述的外管7与操作手柄连接,内部设有两个腔,分别为第一腔12和第二腔13,传动丝9设置于第二腔13中;所述的鲁尔接头6设置于外管7靠近操作手柄的一端,分为第一鲁尔接头601和第二鲁尔接头602,第一鲁尔接头601与第一腔 12相通,供导丝穿过;第二鲁尔接头602与第二腔13相通;所述的组织活检负压切取装置还包括切取装置8,所述的切取装置8中空,可拆卸的设置于传动丝 9的末端;所述的第二鲁尔接头602连接负压装置,所述的负压装置可以为针管或者负压吸引器,第二鲁尔接头602末端与负压吸引器密封连接,通过负压吸引器抽出第二腔13内的空气,使得第二腔13内形成相对负压状态,负压的吸力作用使得胆管壁更贴近于切取装置8,推动切取装置8便可实现切取样品。A tissue biopsy negative pressure cutting device for bile duct stenosis disease, comprising an operating handle, a
优选的,所述的切取装置8呈针头状,针头状的取样装置8末端锋利,接触面小,取样时加以负压的作用,使得胆管壁贴近切取装置8,轻轻推动切取装置8便可实现取样,且对胆管壁的伤害小,同时,针头状的取样装置8的口径大,内腔大,能够储存更多的样品。Preferably, the
优选的,所述的切取装置8呈圆柱状,一端可拆卸的与传动丝9连接,另一端封闭,侧壁设有至少两个倒刺10,所述的倒刺10与切取装置8内腔相通,经倒刺10切取得到的样本组织储存在切取装置8内,同时切取装置8封闭的腔体也可防止因切取装置8的移动而丢失样本组织,且倒刺10的尖端能够挂住样本组织而防止组织丢失,进行二次取样对患者造成伤害。Preferably, the
优选的,所述的切取装置8由金属、合金、陶瓷、硬性塑料或其他可实现本技术方案的材料制成。硬质材料更有利于切取组织。Preferably, the
优选的,所述的切取装置8由不锈钢制成。Preferably, the
优选的,所述的倒刺10由金属、合金或其他可实现本技术方案的材料制成。Preferably, the
优选的,所述的倒刺10由不锈钢材料制成。Preferably, the
优选的,所述的倒刺10的方向可与切取装置8推动的方向相同和/或相反,在切取装置8推或拉时均可收集活检组织,减少操作次数,增加取样量,降低对患者的伤害。Preferably, the direction of the
优选的,所述的切取装置8上设有两个方向相反的倒刺10,便于收集活检组织。Preferably, the
优选的,所述的倒刺10与切取装置8侧壁的夹角为0-10°。Preferably, the angle between the
优选的,所述的倒刺10与切取装置8侧壁的夹角为3-6°。Preferably, the angle between the
优选的,所述的倒刺10与切取装置8侧壁的夹角为5°。Preferably, the included angle between the
优选的,所述的芯杆1上设有刻度,医护人员可根据刻度推拉传动丝9,减少对患者的创伤。Preferably, the
优选的,所述的外管7靠近操作手柄的一端设置有护套管5,护套管5套在外管7上。Preferably, the end of the
优选的,所述的外管7的横截面呈圆形、椭圆形或者其他任何能够实现本技术方案的形状。Preferably, the cross section of the
本实用新型的有益效果是:①当使用针头状切取装置8时,医护人员根据导丝指定的位置,将取样装置推进到指定位置后,第二鲁尔接头602连接负压装置,使得第二腔13形成负压状态,负压的吸力作用将胆管壁贴近切取装置8,推动滑块2,使得切取装置8与胆管壁接触,并切取病理组织。同时,在负压的作用下,取下的组织进入切取装置8腔内保存,而不会因为切取装置8的移动或者角度变化丢失样品;②当使用设有倒刺的切取装置8时,经倒刺10切取得到的样本组织储存在切取装置8内,同时切取装置8封闭的腔体也可防止因切取装置8的移动而丢失样本组织,且倒刺10的尖端能够挂住样本组织而防止组织丢失,进行二次取样对患者造成伤害。本实用新型的切取装置8可准确的定位病理组织的位置并切取,切取过程简单,对组织的创伤小,切取装置8的储样量大,且在取出的过程中样品不会丢失,得到的样品阳性检出率高,可在临床上推广应用。The beneficial effects of the present invention are as follows: 1. When the needle-
附图说明Description of drawings
图1一种用于胆管狭窄性疾病的组织活检负压切取装置1的主视图Figure 1 is a front view of a tissue biopsy negative
1、芯杆;2、滑块;3、助推杆;5、护套管;6、鲁尔接头;601、第一鲁尔接头;602、第二鲁尔接头;7、外管;8、切取装置;9、传动丝1. Core rod; 2. Slider; 3. Booster rod; 5. Sheathing tube; 6. Luer connector; 601, First Luer connector; 602, Second Luer connector; 7. Outer tube; 8 , cutting device; 9, transmission wire
图2一种用于胆管狭窄性疾病的组织活检负压切取装置2的主视图FIG. 2 is a front view of a tissue biopsy negative
1、芯杆;2、滑块;3、助推杆;5、护套管;6、鲁尔接头;601、第一鲁尔接头;602、第二鲁尔接头;7、外管;8、切取装置;9、传动丝;10、倒刺;1. Core rod; 2. Slider; 3. Booster rod; 5. Sheathing tube; 6. Luer connector; 601, First Luer connector; 602, Second Luer connector; 7. Outer tube; 8 , cutting device; 9, transmission wire; 10, barb;
图3一种用于胆管狭窄性疾病的组织活检负压切取装置部分剖面图Figure 3 is a partial cross-sectional view of a tissue biopsy negative pressure cutting device for bile duct stricture disease
1、芯杆;2、滑块;3、助推杆;601、第一鲁尔接头;602、第二鲁尔接头; 7、外管;9、传动丝;12、第一腔;13、第二腔1. Core rod; 2. Slider; 3. Booster rod; 601, First Luer connector; 602, Second Luer connector; 7, Outer tube; 9, Transmission wire; 12, First cavity; 13, second chamber
图4外管7的横截面Figure 4 Cross-section of the
7、外管;8、切取装置;9、传动丝;12、第一腔;13、第二腔7. Outer tube; 8. Cutting device; 9. Transmission wire; 12. First cavity; 13. Second cavity
图5倒刺10的形状Figure 5 Shape of
具体实施方式Detailed ways
下面结合具体实施例对本实用新型的技术方案进行说明,但是本实用新型技术方案的保护范围并不限定于以下实施例,任何本领域技术人员在不改变本实用新型技术方案宗旨的前提下,对技术方案进行简单的修改、替换或者变形,均属于本实用新型技术方案的保护范围。The technical solutions of the present utility model will be described below in conjunction with specific embodiments, but the protection scope of the technical solutions of the present utility model is not limited to the following examples. Simple modification, replacement or deformation of the technical solution all belong to the protection scope of the technical solution of the present invention.
实施例1、一种用于胆管狭窄性疾病的组织活检负压切取装置1
一种用于胆管狭窄性疾病的组织活检负压切取装置,包括操作手柄、鲁尔接头6、外管7和传动丝9,所述的操作手柄由芯杆1、滑块2和助推杆3组成,所述的芯杆1呈中空杆状,一端设有内螺纹,另一端设有手柄环,侧壁设有开口;助推杆3设置于芯杆1内部,滑块2嵌套在芯杆1上,与芯杆1可相对滑动;助推杆3一端连接在滑块2上,助推杆3的另一端连接传动丝9;所述的外管7上设有外螺纹,外管7和芯杆1通过螺纹连接,所述的外管7与操作手柄连接,内部设有两个腔,分别为第一腔12和第二腔13,传动丝9设置于第二腔 13中;所述的鲁尔接头6设置于外管7靠近操作手柄的一端,分为第一鲁尔接头601和第二鲁尔接头602,第一鲁尔接头601与第一腔12相通,供导丝穿过;第二鲁尔接头602与第二腔13相通;所述的组织活检负压切取装置还包括切取装置8,所述的切取装置8中空,末端锋利,可拆卸的设置于传动丝9的末端;所述的第二鲁尔接头602连接负压装置,所述的负压装置可以为针管,所述的第二鲁尔接头602末端与针管密封连接,通过抽拉针管抽出第二腔13内的空气,使得第二腔13内形成负压状态,负压使得胆管壁更贴近于切取装置8,便于切取足够的组织样品。所述的切取装置8由金属钢制成,呈针头状。所述的芯杆1 上设有刻度,医护人员可根据刻度推拉传动丝9,减少对患者的创伤。所述的外管7靠近操作手柄的一端设置有护套管5,护套5套在外管7上。所述的外管7 的横截面呈圆形。A tissue biopsy negative pressure cutting device for bile duct stenosis disease, comprising an operating handle, a luer connector 6, an outer tube 7 and a transmission wire 9, the operating handle is composed of a core rod 1, a slider 2 and a booster rod 3, the core rod 1 is in the shape of a hollow rod, one end is provided with an internal thread, the other end is provided with a handle ring, and the side wall is provided with an opening; the booster rod 3 is arranged inside the core rod 1, and the slider 2 is nested in the The core rod 1 is slidable relative to the core rod 1; one end of the booster rod 3 is connected to the slider 2, and the other end of the booster rod 3 is connected to the transmission wire 9; The tube 7 and the core rod 1 are connected by threads, the outer tube 7 is connected with the operating handle, and there are two cavities inside, which are the first cavity 12 and the second cavity 13 respectively, and the transmission wire 9 is arranged in the second cavity 13 The described Luer connector 6 is arranged at one end of the outer tube 7 close to the operating handle, and is divided into a first Luer connector 601 and a second Luer connector 602, and the first Luer connector 601 communicates with the first cavity 12 for guiding The second luer connector 602 communicates with the second cavity 13; the tissue biopsy negative pressure cutting device further includes a cutting device 8, the cutting device 8 is hollow, the end is sharp, and is detachably arranged on the transmission wire The end of 9; the second luer connector 602 is connected to a negative pressure device, and the negative pressure device can be a needle tube, and the end of the second luer connector 602 is sealedly connected to the needle tube, and the second luer connector 602 is sealed and connected to the needle tube. The air in the
实施例2、一种用于胆管狭窄性疾病的组织活检负压切取装置1的使用方法
(1)医护人员先将导丝放入患者胆胰腔道,再将导丝沿着外管7的第一腔 12穿入,通过第一鲁尔接头601穿出,则外管7沿导丝进入胆胰腔道;(1) The medical staff first put the guide wire into the patient's biliopancreatic cavity, and then passed the guide wire along the
(2)根据导丝的指定位置,将所述的组织活检负压切取装置8放置到需要取样的部位;(2) According to the designated position of the guide wire, the tissue biopsy negative
(3)第二鲁尔接头602连接负压装置即针筒,抽拉针筒使得第二腔13内形成负压状态;(3) The
(4)推动滑块2,将与滑块2连接的传动丝9推出第二腔13,则切取装置 8暴露在胆胰腔内,在确定好需要切取的组织后,切取装置8贴紧组织,前后多次推拉传动丝9,切取装置8在推力或者拉力的作用下,不断的切取组织并储存在切取装置8内,芯杆1上设有的刻度可控制推动的距离,降低创伤;(4) Push the
(5)取样结束后,抽出负压切取装置并处理取得的样品。(5) After the sampling is completed, the negative pressure cutting device is pulled out and the obtained sample is processed.
实施例3、一种用于胆管狭窄性疾病的组织活检负压切取装置2
一种用于胆管狭窄性疾病的组织活检负压切取装置,包括操作手柄、鲁尔接头6、外管7和传动丝9,所述的操作手柄由芯杆1、滑块2和助推杆3组成,所述的芯杆1呈中空杆状,一端设有内螺纹,另一端设有手柄环,侧壁设有开口;助推杆3设置于芯杆1内部,滑块2嵌套在芯杆1上,与芯杆1可相对滑动;助推杆3一端连接在滑块2上,助推杆3的另一端连接传动丝9;所述的外管7上设有外螺纹,外管7和芯杆1通过螺纹连接。所述的芯杆1上设有刻度,医护人员可根据刻度推拉传动丝9,减少对患者的创伤,所述的外管7与操作手柄连接,内部设有两个腔,分别为第一腔12和第二腔13,传动丝9设置于第二腔13中;所述的鲁尔接头6设置于外管7靠近操作手柄的一端,分为第一鲁尔接头601和第二鲁尔接头602,第一鲁尔接头601与第一腔12相通,供导丝穿过;第二鲁尔接头602与第二腔13相通;所述的组织活检负压切取装置还包括切取装置8,所述的切取装置8呈圆柱状,一端可拆卸的与传动丝9连接,另一端封闭,侧壁一体成型的设有倒刺10。所述的切取装置8由不锈钢制成,其上设有两个倒刺10,两个倒刺10的方向相反。所述的倒刺10与切取装置8管壁的夹角为5°。所述的外管7靠近操作手柄的一端设置有护套管5,护套管5套在外管7上。所述的外管7的横截面呈圆形。A tissue biopsy negative pressure cutting device for bile duct stenosis disease, comprising an operating handle, a
实施例4、一种用于胆管狭窄性疾病的组织活检负压切取装置2的使用方法Embodiment 4. A method of using tissue biopsy negative
(1)医护人员先将导丝放入患者胆胰腔道,再将导丝沿着外管7的第一腔 12穿入,通过第一鲁尔接头601穿出,则外管7沿导丝进入胆胰腔道;(1) The medical staff first put the guide wire into the patient's biliopancreatic cavity, and then passed the guide wire along the
(2)根据导丝的指定位置,将所述的组织活检负压切取装置8放置到需要取样的部位;(2) According to the designated position of the guide wire, the tissue biopsy negative
(3)第二鲁尔接头602连接负压装置即针筒,抽拉针筒使得第二腔13内形成负压状态;(3) The
(4)推动滑块2,将与滑块2连接的传动丝9推出第二腔13,则切取装置8暴露在胆胰腔内,在确定好需要切取的组织后,切取装置8贴紧组织,前后多次推拉传动丝9,切取装置8上的倒刺10在推力或者拉力的作用下,不断的切取组织并储存在切取装置8内,芯杆1上设有的刻度可控制推动的距离,降低创伤;(4) Push the
(5)取样结束后,抽出负压切取装置并处理取得的样品。(5) After the sampling is completed, the negative pressure cutting device is pulled out and the obtained sample is processed.
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CN111000593A (en) * | 2019-10-16 | 2020-04-14 | 兰州大学第一医院 | Tissue biopsy negative pressure cutting device for bile duct stenosis diseases |
CN111000592A (en) * | 2019-10-16 | 2020-04-14 | 兰州大学第一医院 | A tissue biopsy cutting device for bile duct stricture disease |
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CN111000593A (en) * | 2019-10-16 | 2020-04-14 | 兰州大学第一医院 | Tissue biopsy negative pressure cutting device for bile duct stenosis diseases |
CN111000592A (en) * | 2019-10-16 | 2020-04-14 | 兰州大学第一医院 | A tissue biopsy cutting device for bile duct stricture disease |
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