厂家供应日本八光穿刺针PTC-B型
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厂家供应日本八光穿刺针PTC-B型
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 穿刺针HAKKO SONOGUIDE PTC NEEDLE
管理类别 第二类
型号规格 见附页
结构及组成/主要组成成分 本产品是由内针、外针、保护管、标记、内针基座、外针基座构成。环氧乙烷灭菌，一次性使用。
适用范围/预期用途 本产品作为穿刺针主要适用于经皮对胆管及胆囊的穿刺和造影。
18G（粉红色手柄）
B-18G×150mmB-18G×180mmB-18G×200mmB-18G×250mm
19G（棕色手柄）
B-19G×150mmB-19G×180mmB-19G×200mm
20G（黄色手柄）
B-20G×120mmB-20G×150mmB-20G×180mmB-20G×200mmB-20G×250mmB-20G×300mmB-20G×350mm
21G（绿色手柄）
B-21G×100mmB-21G×120mmB-21G×150mmB-21G×180mmB-21G×200mmB-21G×250mmB-21G×300mmB-21G×350mm
22G（黑色手柄）
B-22G×100mmB-22G×120mmB-22G×150mmB-22G×180mmB-22G×200mmB-22G×250mmB-22G×300mmB-22G×350mm
23G（浅蓝色手柄）
B-23G×100mmB-23G×120mmB-23G×150mmB-23G×180mmB-23G×200mmB-23G×250mmB-23G×300mmB-23G×350mm
一、工作原理 Working Principle
中文在超声影像实时引导下，带内针的同轴穿刺套件经皮肤、软组织穿刺抵达目标病灶；内针起到封闭外针内腔、平稳引导穿刺作用，降低组织被外针切割损伤风险。穿刺到达预定深度后拔出内针，外针形成独立工作通道；可通过外针内腔完成液体抽吸、造影剂注射、药物灌注、标本取样等操作。针体前端粗面超声显影处理，在超声图像下清晰识别针尖位置；配套滑动游标与刻度标记，术中控制穿刺进针深度，防止穿刺过深误伤深部脏器。
EnglishUnder real-time ultrasonic guidance, the coaxial puncture set with inner stylet penetrates skin and soft tissue to reach target lesion. The inner stylet seals the outer needle lumen and guides puncture smoothly, reducing tissue laceration risk caused by outer cannula. After reaching target depth, withdraw inner stylet, leaving outer cannula as independent working channel. Liquid aspiration, contrast medium injection, drug instillation and specimen sampling can be perｆormed through outer needle lumen.Roughened echogenic treatment at needle tip enables clear visualization under ultrasound. Equipped with sliding marker and scale marks to precisely control penetration depth and avoid accidental injury to deep organs.
二、产品功能 Functions
中文
超声引导下经皮穿刺建立微创通路，用于胆管、胆囊穿刺造影；
拔出内针后，经由外针通道抽吸囊液、胆汁、病灶液体；
可通过外针通道注射造影剂、硬化剂、治疗药物；
前端超声显影结构，术中实时追踪针尖位置；
针体刻度 + 滑动游标，管控穿刺深度；
标准鲁尔基座，兼容注射器、延长管路，方便术中连接操作。
English
Establish minimally invasive access via percutaneous puncture under ultrasound guidance for gallbladder and biliary tract puncture and cholangiography;
After removing inner stylet, aspirate cyst fluid, bile or lesion fluid through outer cannula;
Inject contrast medium, sclerosant or therapeutic agents via outer needle lumen;
Distal echogenic design allows real-time tracking of needle tip during operation;
Shaft scale marks and sliding marker achieve precise depth control;
Standard Luer hub compatible with syringes and extension tubing for convenient intraoperative connection.
三、产品特点 Product Features
中文
针尖前端粗面超声显影工艺：超声辨识度高，针尖清晰可见，提升穿刺安全性；
同轴内外针套件设计，穿刺过程封闭通道，降低组织划伤风险；
外针每 10mm 印刷刻度，搭配可移动深度游标，把控进针深度；
医用 304 不锈钢针管，韧性优良，不易弯折，管壁内外精密抛光，组织摩擦损伤小；
多规格梯度齐全：18G/19G/20G/21G/22G/23G；长度 150/180/200mm，适配深浅不同病灶；
不同规格针座采用彩色区分，手术室快速辨识型号；
原装日本进口，独立 EO 无菌包装；一次性使用；
操作通用性强，除注册适应症外，广泛用于囊肿穿刺、药物注射、卵泡穿刺等合规拓展操作。
English
Roughened echogenic tip technology for superior ultrasonic visibility and improved puncture safety;
Coaxial inner stylet & outer cannula design maintains sealed channel during penetration and reduces tissue injury;
10mm interval scale marks on outer shaft together with sliding depth marker for accurate penetration control;
Medical grade 304 stainless steel shaft with excellent flexibility and kink resistance. Precisely polished inner and outer surface minimizes tissue friction trauma;
Complete specification portfolio: 18G/19G/20G/21G/22G/23G; length 150/180/200mm for superficial and deep lesions;
Color-coded hub for quick visual identification in operating room;
Original imported from Japan, individually EO sterile packaged for single use;
Wide clinical versatility; besides registered indication, widely adopted for cyst puncture, drug injection and follicle puncture within hospital protocol.
四、技术参数 Technical Specifications
| 中文 | English |
|---|---|
| 产品型号：PTC-B 系列 B-XXG×XXXmm | Model: PTC-B Series B-XXG×XXXmm |
| 常用规格：18G、19G、20G、21G、22G、23G | Available Gauge: 18G,19G,20G,21G,22G,23G |
| 有效长度：150mm / 180mm / 200mm | Working Length: 150mm / 180mm / 200mm |
| 针体材质：医用 304 奥氏体不锈钢 | Shaft Material: Medical grade 304 austenitic stainless steel |
| 灭菌方式：环氧乙烷（EO） | Sterilization: Ethylene Oxide (EO) |
| 使用属性：一次性使用，严禁复用、二次灭菌 | Usage: Single-use only; reuse & resterilization prohibited |
| 显影方式：针尖前端粗面超声显影 | Echogenic Feature: Roughened distal tip for ultrasound visualization |
| 货架有效期：3 年 | Shelf Life: 3 years |
| 标准包装：25 支 / 盒 | Standard Package: 25 units per box |
五、使用方法 Operation Instructions
中文
使用前核查外包装完整性、无菌状态与有效期，洁净区域拆封；
根据病灶深度选择合适规格穿刺针，检查内针、外针滑动顺畅无卡滞；
术前完成皮肤消毒、局部麻醉，将穿刺针装配于超声穿刺导向架；
超声实时监控，持针平稳穿刺组织，按照游标刻度控制进针深度；
针尖抵达目标位置后，固定外针，缓慢拔出内针；
鲁尔基座连接注射器或延长管路，实施抽吸、造影或药物注射操作；
诊疗操作全部完成后，在影像监控下平稳整体拔出整套穿刺针；
使用完毕按照医疗锐器废弃物规范处置。
English
Verify package integrity, sterile barrier and expiry date before use; unpack in clean area;
Select proper size according to lesion depth, check smooth sliding of inner stylet and outer cannula;
Perｆorm skin disinfection and local anesthesia, mount needle onto ultrasound guide sheath;
Advance needle steadily under continuous ultrasonic monitoring, control penetration depth referring to sliding marker and shaft scales;
Fix outer cannula when tip reaches target position, then withdraw inner stylet slowly;
Connect Luer hub with syringe or extension tubing for aspiration, contrast injection or drug administration;
After treatment, withdraw the whole set steadily under image monitoring;
Dispose used needle as regulated sharp medical waste.
六、适应症 Indications
中文根据医疗器械注册预期用途：适用于经皮对胆管及胆囊进行穿刺和造影（经皮经肝胆囊 / 胆管造影 PTC、PTCD 术前穿刺定位）。院内合规拓展应用（遵循科室规范与医师评估）：脏器囊肿穿刺抽液、硬化治疗；病灶局部药物注射；妇科卵泡、卵巢囊肿穿刺等超声介入微创操作。
EnglishIn accordance with registered intended use: indicated for percutaneous puncture and cholangiography of bile duct and gallbladder (PTC, pre-PTCD puncture localization).Extended clinical applications (comply with hospital protocol and physician assessment): cyst aspiration and sclerotherapy, local lesion drug injection, gynecological follicle and ovarian cyst puncture and other ultrasound-guided minimally invasive interventions.
七、禁忌症 Contraindications
中文
穿刺路径存在急性活动性感染、皮肤脓肿；
严重凝血功能障碍、持续出血倾向，无法耐受穿刺创伤；
目标脏器巨大动脉瘤、可疑恶性病变未经术前评估；
超声下无安全穿刺通路，穿刺极易损伤大血管、空腔脏器；
已知对不锈钢、聚丙烯、EO 灭菌残留物存在严重过敏；
严重全身性疾病，无法耐受微创穿刺操作。
English
Active acute infection or skin abscess along puncture trajectory;
Severe coagulopathy and persistent bleeding diathesis unable to tolerate puncture trauma;
Giant aneurysm of target organ or suspected malignant lesion without adequate preoperative evaluation;
No safe ultrasound-guided access route with high risk of injury to large vessels or hollow viscera;
Known severe allergy to stainless steel, polypropylene and EO residuals;
Severe systemic disease intolerant to minimally invasive puncture.
八、注意事项 Precautions
中文
经过超声介入规范化培训医师操作，全程严格无菌操作；
外包装破损、漏气、超出灭菌有效期严禁使用；一次性使用，禁止清洗、重复穿刺复用；
穿刺全程保持超声实时监视，禁止盲穿；持续观察显影针尖，防止误伤血管、肠道；
进针遇明显阻力时禁止强行推送，避免针体弯折、脏器撕裂；
拔出内针前必须确认针尖抵达目标区域，防止误刺入正常组织；
术中密切监测患者生命体征，警惕出血、胆漏、脏器损伤等并发症；
严禁暴力弯折、碾压针体，防止管路变形堵塞；
使用后的穿刺针头投入专用锐器盒，预防针刺伤。
English
Operation limited to physicians ｆormally trained in ultrasound intervention; strict sterile technique required throughout procedure;
Do not use if package damaged, leaking or expired. Single-use only; cleaning and reuse are strictly forbidden;
Continuous real-time ultrasound monitoring is mandatory; blind puncture prohibited. Track echogenic tip to avoid vessel and bowel injury;
Do not advance forcefully against obvious resistance to prevent shaft kinking and visceral laceration;
Confirm tip position before removing inner stylet to prevent accidental penetration into normal tissue;
Closely monitor patient vital signs during operation, watch for complications such as hemorrhage, bile leakage and organ injury;
Avoid violent bending or squeezing needle shaft to prevent deｆormation and blockage;
Discard used sharp needle into dedicated sharps container to prevent needlestick injury.
九、存储条件 Storage Conditions
中文储存环境温度：5℃～30℃；相对湿度：30%～75%，环境无凝露；环境要求：干燥通风、无尘；避免阳光直射、重压、撞击；远离腐蚀性气体、有机溶剂；产品保持原装密封包装，平放或直立存放；禁止冷冻、高温烘烤；需在 3 年货架有效期内使用，超过有效期严禁临床使用。
EnglishStorage Temperature：5℃～30℃;Relative Humidity：30%～75%, no condensation;Requirements：Dry, ventilated and dust-free; avoid direct sunlight, heavy compression and impact; keep away from corrosive gas and organic solvents;Store horizontally or vertically in intact original sealed package. Freezing and high-temperature baking are prohibited;Use within 3-year shelf life. Expired products are forbidden for clinical application.
Shanghai Kangshida Medical Devices Co., Ltd. is a professional company engaged in the sales of medical devices, focusing on the agency and distribution of renowned medical equipment brands from both domestic and international markets. Its core product range covers full-scenario medical devices for physical examination, diagnosis, emergency treatment, laboratory testing, ultrasound, medical analysis, life sciences, disinfection and sterilization, rehabilitation therapy, operating rooms, emergency rooms, consulting rooms and other fields. Relying on its strong product sales capacity, excellent commercial reputation and integrity-based operation philosophy, the company has won unanimous recognition and trust from medical institutions and partners.
The steady and rapid development of the company is attributed to its carefully selected high-quality product portfolio. It always takes customer needs as the core orientation and is committed to creating long-term value and practical benefits for customers. As an authorized and exclusive agent for many well-known domestic and international manufacturers, the company has established a complete supply system of medical devices with reliable quality, fully meeting the needs of clinical diagnosis and treatment.
The company always takes improving customer satisfaction as its core goal. To strictly adhere to product standards and exceed the expectations of customers and manufacturers, it regularly provides training on professional ethics and professional business skills, forging a highly competent, efficient and executive team covering business, technology and management. The team implements a 7×24-hour all-weather response mechanism to provide professional and high-quality after-sales service and technical support, efficiently solving various equipment operation and maintenance problems. At the same time, the company offers exclusive services including same-day delivery and free distribution, ｆorming a closed loop covering supply, distribution and after-sales service to fully ensure the stable supply and worry-free use of medical equipment for medical institutions.
Upholding integrity as the foundation of its business, the company selects high-quality medical devices and provides professional services for customers, helping to upgrade the quality of medical services and contributing to the high-quality development of China's medical industry.
Intellectual Property Infringement Complaint: Kangshida Medical does not manufacture medical products; all products are sourced from original manufacturers. We will promptly address any intellectual property infringement issues.The content published herein is for reference only.
热门标签：厂家供应日本八光穿刺针PTC-B型,八光穿刺针,穿刺针PTC-B
