CN211749750U - Tissue biopsy cutting device for bile duct stenosis diseases - Google Patents
Tissue biopsy cutting device for bile duct stenosis diseases Download PDFInfo
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- 238000005520 cutting process Methods 0.000 title claims abstract description 59
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- 206010051341 Bile duct stenosis Diseases 0.000 title claims abstract description 15
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- 230000008569 process Effects 0.000 abstract description 4
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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切取装置,包括操作手柄、鲁尔接头、外管和传动丝,所述的外管内空,一端与操作手柄连接,传动丝置于外管和操作手柄内;所述的鲁尔接头设置于外管侧壁靠近操作手柄的一端;所述的组织活检切取装置还包括切取装置,所述的切取装置呈中空圆柱状,可拆卸的设置于传动丝的末端,所述的切取装置侧壁设有至少两个倒刺。本实用新型的倒刺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,金属管储样量大,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 cutting device for bile duct stenosis diseases, comprising an operating handle, a Luer connector, an outer tube and a transmission wire. connection, the transmission wire is placed in the outer tube and the operating handle; the luer connector is arranged on one end of the outer tube side wall close to the operating handle; the tissue biopsy cutting device also includes a cutting device, and the cutting device is hollow The cylindrical shape is detachably arranged at the end of the transmission wire, and the side wall of the cutting device is provided with at least two barbs. The barb of 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 capacity of the metal tube is large, and the sample will not be lost in the process of taking out, and the obtained sample is positive. The yield is high, and it can be popularized and 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切取装置。The utility model relates to the technical field of medical devices, in particular to a tissue biopsy cutting device used 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 such as 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.
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。The utility model patent "Biopsy Forceps with Guide Wire Channel" (201620656702.X) discloses a biopsy forceps with a guide wire channel, which can quickly and efficiently remove the pancreaticobiliary stent and can enter the pancreaticobiliary duct lesions for biopsy sampling. The device has undergone a comprehensive study and found that it is sampled through the crocodile-shaped forceps tip. 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 prevent patients from sampling during biopsy In case of a large trauma or a medical accident, a small operation force must be ensured, then the crocodile tooth-shaped forceps head cannot be fully contacted, resulting in insufficient amount of scraped tissue, requiring multiple samplings to meet the requirements, which actually leads to the patient The damage is aggravated; 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 the inclination angle between the forceps head and the bile duct cannot be accurately judged and controlled and sampling intensity, resulting in huge trauma to the patient during the sampling process, 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 present utility model discloses a tissue biopsy cutting device for bile duct stenosis diseases. Compared with the biopsy forceps disclosed in the prior art, the device has a precise sampling position, a large sampling volume, and has the advantages of The patient's trauma is small.
发明内容SUMMARY OF THE INVENTION
一种用于胆管狭窄性疾病的组织活检切取装置,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内空,一端与操作手柄连接,传动丝9置于外管7和操作手柄内;所述的鲁尔接头6设置于外管7侧壁靠近操作手柄的一端;所述的组织活检切取装置还包括切取装置8,所述的切取装置8呈中空圆柱状,可拆卸的设置于传动丝9的末端,所述的切取装置8侧壁设有至少两个倒刺10,所述的倒刺10开口与切取装置8 的内部相通,便于将切取得到的样本组织储存在切取装置8内部,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。A tissue biopsy cutting device for bile duct stricture disease, comprising an operating handle, a
优选的,所述的切取装置8由金属、陶瓷、硬性塑料或其他可实现本技术方案的材料制成,所述的倒刺10由金属、合金材料或其他可实现本技术方案的材料制成,硬质,锋利的材料更有利于组织取样。Preferably, the
优选的,所述的切取装置8和倒刺10均由金属钢制成。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上设置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管壁的夹角为0-10°,倾斜的角度更有利于倒刺10与胆管壁的接触,从胆管壁上收集活检组织。Preferably, the angle between the
优选的,所述的倒刺10与切取装置8管壁的夹角为3-6°。Preferably, the angle between the
优选的,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,推动滑块2,带动助推杆3和传动丝9在第二腔13内滑动,所述的芯杆1上设有刻度,医护人员可根据刻度调节滑块2的位置。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5套在外管7的外表面。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:医护人员根据导丝指定的位置,将切取装置推进到指定位置时,通过不断推拉滑块2,使得传动丝9末端的切取装置8与病理组织接触,切取装置8侧壁的倒刺10切取病理组织,并不断将切取的组织储存在切取装置8的内部,以防取出取样装置时将病理组织丢失,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 beneficial effect of the utility model is that: when the medical staff pushes the cutting device to the designated position according to the position designated by the guide wire, the
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切取装置的主视图Figure 1 is a front view of a tissue biopsy cutting device for bile duct stricture disease
1、芯杆;2、滑块;3、助推杆;5、护套管;6、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; 7. Outer tube; 8. Cutting device; 9. Transmission wire; 10. Barb
图2一种用于胆管狭窄性疾病的组织活检切取装置的剖视图Figure 2 is a cross-sectional view of a tissue biopsy cutting device for bile duct stricture disease
1、芯杆;2、滑块;3、助推杆;6、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; 6. Luer connector; 7. Outer tube; 9. Transmission wire; 12. First cavity; 13. Second cavity
图3倒刺10的不同状态Figure 3 Different states of
图4外管7的横截面1Figure 4
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外管7的横截面2Figure 5
7、外管;8、切取装置;9、传动丝;7. Outer tube; 8. Cutting device; 9. Transmission wire;
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切取装置
一种用于胆管狭窄性疾病的组织活检切取装置,包括操作手柄、鲁尔接头6、外管7和传动丝9,所述的外管7内空,一端与操作手柄连接,传动丝9置于外管7和操作手柄内;所述的鲁尔接头6设置于外管7侧壁靠近操作手柄的一端;所述的组织活检切取装置还包括切取装置8,所述的切取装置8呈中空圆柱状,可拆卸的设置于传动丝9的末端,所述的切取装置8侧壁设有两个方向相反的倒刺10,所述的切取装置8和倒刺10均由金属钢制成。便于收集活检组织,所述的倒刺10与切取装置8管壁的夹角为5°,倾斜的角度更有利于倒刺10与胆管壁的接触,从胆管壁上收集活检组织。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,推动滑块2,带动助推杆3和传动丝9在第二腔13内滑动,所述的芯杆 1上设有刻度。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的外表面。所述的外管7的横截面呈圆形。A tissue biopsy cutting device for bile duct stenosis disease, comprising an operating handle, a
实施例2、一种用于胆管狭窄性疾病的组织活检切取装置的使用方法
(1)操作过程中,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,通过鲁尔接头6穿出,则外管7沿导丝进入并到达胆胰腔道的指定位置;(1) During the operation, the medical staff first put the guide wire into the biliopancreatic cavity of the patient, then passed the guide wire along the
(2)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;(2) push the
(3)确定需要切取的组织,推动滑块2使切取装置8贴紧组织,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,取样结束后,抽出组织活检切取装置并处理取得的样品。(3) Determine the tissue to be cut, push the
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