厂家美国Argon爱琅同轴引导活检针MCXS1815BP
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厂家美国Argon爱琅同轴引导活检针MCXS1815BP
桂经理19117326863微xin同号
产品名称
同轴引导活检针Co-Axial Introducer Needles
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
活检针由带内圆锥锁定接头的针管、带外圆锥锁定接头的针芯、定位器三部分组成。针管材料为304不锈钢、针芯材料为304不锈钢、定位器材料为302不锈钢。产品经环氧乙烷灭菌，为一次性使用。
适用范围/预期用途
活检针用于人体软组织活体检查的引导取样。
一、BP 标准款（临床最常用，适配 Tru-Core/BioPince 活检针）
MCXS1410BP — 13G×5.1cm
MCXS1610BP — 15G×6.8cm
MCXS1615BP — 15G×11.8cm
MCXS1810BP — 17G×6.8cm
MCXS1815BP — 17G×11.8cm
MCXS1820BP — 17G×16.8cm
二、BPU 加长护套款
MCXS1610BPU
MCXS1615BPU
MCXS1810BPU
MCXS1815BPU
三、TX 薄壁款（软组织精细活检）
MCXS1410TX — 13G×5.1cm
MCXS1816TX — 17G×11.1cm
MCXS1820TX — 17G×15.1cm
四、TZ 超细款（浅表 / 甲状腺微小病灶）
MCXS2010TZ — 19G×5.4cm
MCXS2016TZ — 19G×11.4cm
一、工作原理 Working Principle
中文
在 CT / 超声影像引导下，同轴引导活检针组装穿刺针芯，一次性经皮肤穿刺抵达病灶边缘；拔除穿刺针芯后，针管（同轴套管）在体内建立一条稳定、连续的微创通道。后续自动活检枪可通过该套管通道多次进入病灶采集组织标本，无需反复穿刺皮肤；套管通道可隔离穿刺路径上正常组织，减少肿瘤细胞针道种植风险；同时可经套管注入止血药、生理盐水等，实现术中辅助处置。
English
Under CT or ultrasound image guidance, the coaxial introducer needle assembled with sharp stylet is percutaneously punctured to the edge of target lesion. After removing the stylet, the cannula establishes a stable continuous minimally invasive access inside the body. Automatic biopsy instrument can be advanced repeatedly through this cannula to acquire tissue samples without repeated skin puncture. The cannula isolates normal tissue along the puncture tract to reduce risk of tumor seeding. Hemostatic agents or saline can also be injected through the cannula for intraoperative adjuvant management.
二、产品功能 Functions
中文
建立同轴微创通道：一次性穿刺建立通路，支持多次组织取样；
引导活检器械：为自动活检枪提供导向通道，保障取样路径稳定；
降低针道种植风险：套管隔绝病灶组织与体表穿刺路径正常组织；
术中给药通道：可经套管注射止血剂、局部麻醉药、生理盐水；
监测与排气：操作中可抽吸评估有无出血，排出通道内气体；
深度标识：套管刻度便于影像下实时监控穿刺深度，防止过穿损伤。
English
Establish coaxial minimally invasive access: single puncture to create tract for multiple tissue sampling;
Guide biopsy device: provide stable channel for automatic biopsy needle;
Reduce tumor tract seeding risk: cannula separates lesion tissue from normal tissue along puncture path;
Intraoperative drug delivery channel: injection of hemostatic agents, local anesthetics and saline;
Aspiration & venting: aspirate to check hemorrhage and evacuate air inside tract;
Depth reference: graduated markings allow real-time depth monitoring under imaging to avoid over-penetration injury.
三、产品特点 Product Features
中文
超声显影针尖（Echogenic Tip）：针尖特殊加工，超声下清晰识别，适配超声、CT 双模态引导；
同轴一体化设计：针管内壁光滑，活检枪进出顺畅，降低卡针风险；
外壁厘米深度刻度：影像下直观判断进针深度；
锋利穿刺针芯：轻松穿透皮肤、筋膜、软组织，穿刺阻力小；
标准鲁尔锁定接头，兼容 Argon BioPince 系列活检器械；
一次性无菌 EO 灭菌，杜绝交叉感染；
套管刚性适中，不易弯折，维持穿刺路径稳定；
一次穿刺多点取样，减少皮肤穿刺次数，降低出血、气胸等并发症概率。
English
Echogenic tip: specially treated tip for clear visualization under ultrasound, compatible with both ultrasound and CT guidance;
Integrated coaxial design: smooth inner cannula lumen ensures smooth advancement of biopsy instrument, minimizing jamming risk;
Centimeter graduation marks on outer cannula for direct depth visualization under imaging;
Sharp stylet enables easy penetration of skin, fascia and soft tissue with low puncture resistance;
Standard Luer-lock hub compatible with Argon BioPince biopsy devices;
Single-use EO sterile packaging to prevent cross-contamination;
Appropriate cannula rigidity, resistant to bending to maintain stable access tract;
Multiple sampling via single skin puncture, reducing incidence of hemorrhage, pneumothorax and other complications.
四、技术参数 Technical Specifications
表格
参数 Item 中文 English 型号 Model MCXS1815BP MCXS1815BP 套管规格 Cannula Size 17G，有效长度 11.8 cm 17G, Effective Length: 11.8 cm 适配活检针 Compatible Biopsy Device Argon BioPince 18G 活检枪 360-1580-01 Argon BioPince 18G Biopsy Instrument 360-1580-01 针尖类型 Tip Style 超声增强显影针尖 Echogenic Tip 材质 Material 针管、针芯：304/302 医用不锈钢 Cannula & Stylet: Medical Grade 304/302 Stainless Steel 灭菌方式 Sterilization 环氧乙烷（EO） Ethylene Oxide (EO) 有效期（未开封） 5 年 5 years shelf life 使用方式 一次性使用，禁止重复使用 Single-use only, reuse prohibited 接头规格 标准鲁尔锁定接头 Standard Luer Lock Hub 五、使用方法 Operation Instructions
中文
术前检查：拆除无菌包装，核查型号、有效期；检查套管、针芯无弯折、毛刺、破损；
术前准备：影像定位病灶，体表标记穿刺点，局部麻醉；
组装穿刺：将穿刺针芯完全插入同轴套管内，确保尖端齐平；
影像引导穿刺：在 CT / 超声监视下，缓慢将整套器械经皮肤推进至病灶边缘；
留置通道：固定套管位置，平稳拔出穿刺针芯，保留套管建立同轴通道；
组织取样：将配套自动活检枪沿套管内腔送入，触发活检采集标本；可多次进退活检枪重复取样；
辅助操作：必要时经套管抽吸、注射止血药物或生理盐水；
操作完成：取样结束后，整体拔出同轴套管，穿刺点加压止血；
废弃物处置：整套器械作为医疗废弃物丢弃，严禁清洗复用。
English
Pre-use inspection: Open sterile package, verify model and expiry date; check cannula and stylet for bending, burrs or damage.
Pre-procedure preparation: Target lesion localization under imaging, mark skin entry site and perｆorm local anesthesia.
Assembly: Fully insert sharp stylet into coaxial cannula, confirm tip alignment.
Image-guided puncture: Advance the whole assembly percutaneously to the margin of lesion under continuous CT/ultrasound monitoring.
Secure access tract: Hold cannula stationary, gently withdraw stylet, leave cannula in situ as coaxial channel.
Tissue sampling: Insert matched automatic biopsy instrument through cannula lumen, fire to obtain specimen; repeat sampling as required.
Adjuvant manipulation: Aspirate or inject hemostatic agents / saline via cannula if needed.
Procedure completion: Remove entire coaxial cannula after sampling; apply compression hemostasis at puncture site.
Disposal: Discard whole device as medical waste; reprocessing and reuse are forbidden.
六、适应症 Indications
中文
本品作为同轴引导器械，在影像（CT、超声）引导下，用于人体软组织病变活检建立微创穿刺通道，获取组织病理标本；适用脏器包含肺部、肝脏、肾脏、淋巴结、软组织肿块、腹膜后病灶等软组织占位病变。
English
This device acts as coaxial introducer under CT or ultrasound guidance to establish minimally invasive percutaneous access for soft tissue biopsy and obtain histopathological specimens. Indicated for lesions in lung, liver, kidney, lymph node, soft tissue mass, retroperitoneal lesions and other soft tissue occupying lesions.
七、禁忌症 Contraindications
中文
严重凝血功能障碍、无法纠正的出血倾向患者；
穿刺路径存在活动性感染、脓肿；
病灶紧邻大血管、心脏、重要神经，穿刺风险极高，医师评估无法安全实施活检；
患者无法配合穿刺操作、无法维持体位；
对不锈钢材质过敏者；
包装破损、灭菌失效、超过有效期禁止使用；
不可用于骨组织活检。
English
Patients with severe coagulopathy and uncorrectable bleeding tendency;
Active infection or abscess along the planned puncture tract;
Lesion adjacent to major vessels, heart or vital nerves with unacceptable procedural risk judged by operator;
Patient unable to cooperate and maintain stable position during puncture;
Known hypersensitivity to stainless steel;
Do not use if package damaged, sterilization invalidated or expired;
Not intended for bone biopsy.
八、注意事项 Precautions
中文
经过介入影像培训的医师操作，术前充分评估出血风险；
全程影像实时监控，避免盲目进针损伤血管、脏器；
穿刺针芯未拔除前，禁止活检枪进入套管；
套管留置体内时，不可大幅度扭转、拖拽，防止套管弯折移位；
单次穿刺通道内取样次数遵循临床规范，警惕出血、气胸、针道种植并发症；
一次性无菌产品，严禁清洗、消毒、重复使用；
操作中留意针尖位置，防止套管尖端穿透病灶伤及深部正常组织；
若套管发生堵塞，禁止暴力推送活检器械，必要时整体拔出重新穿刺；
操作完成后持续观察患者有无胸痛、腹痛、出血、呼吸困难等不良反应；
不可在 MRI 环境下使用（不锈钢材质存在安全风险）。
English
Operation restricted to physicians trained in interventional imaging; bleeding risk must be fully evaluated before procedure.
Continuous real-time imaging monitoring is mandatory to avoid blind advancement and injury to vessels or organs.
Do not advance biopsy instrument through cannula before sharp stylet is removed.
Avoid excessive rotation or traction while cannula remains in patient, to prevent bending or displacement.
Follow clinical guidelines for maximum sampling times via single tract; monitor complications including hemorrhage, pneumothorax and tumor seeding.
Single-use sterile device; cleaning, disinfection and reuse are strictly prohibited.
Continuously monitor tip position to prevent over-penetration beyond lesion and injury to deep normal tissue.
If cannula lumen is obstructed, do not force biopsy instrument; remove whole assembly and re-puncture when necessary.
Observe patient after procedure for adverse reactions such as pain, hemorrhage or dyspnea.
Not for use in MRI environment due to stainless steel construction.
九、存储条件 Storage Conditions
中文
储存环境：干燥、清洁、通风、避光室内；
温度范围：5℃～30℃；避免极端高低温；
远离阳光直射、潮湿、腐蚀性气体、尖锐硬物；
产品平放存放，不可重压、挤压，防止套管变形；
按有效期顺序先出；
禁止露天存放、冷藏冷冻。
English
Storage environment: Dry, clean, well-ventilated indoor space, protected from light;
Temperature range: 5℃～30℃; avoid extreme high or low temperature;
Keep away from direct sunlight, moisture, corrosive gas and sharp ｏbjects;
Store flat; heavy compression is forbidden to prevent cannula deｆormation;
Stock rotation: first-expired first-used;
Outdoor storage, refrigeration and freezing are prohibited.
十、说明书核心总结 Summary
中文
MCXS1815BP 为美国 Argon 爱琅 17G×11.8cm 超声显影型同轴引导活检针，归属注册证国械注进 20162142162。在 CT / 超声引导下建立同轴微创穿刺通道，搭配 BioPince 自动活检枪实现一次穿刺多次取样，减少反复穿刺损伤，降低针道肿瘤种植风险；适用于肺、肝、肾、淋巴结等软组织病灶病理活检。产品针尖超声显影、带深度刻度，操作便捷。专业医师一次性无菌使用，术中全程影像监护，警惕出血、气胸等并发症；储存避光常温干燥，严禁重复使用。
English
MCXS1815BP is 17G × 11.8cm echogenic coaxial introducer needle manufactured by Argon Medical Devices, covered under registration No. 国械注进 20162142162. It establishes minimally invasive coaxial access under CT or ultrasound guidance. Matched with BioPince automatic biopsy instrument, it enables multiple tissue sampling via single skin puncture, reduces repeated puncture trauma and lowers risk of tumor tract seeding. Indicated for histologic biopsy of soft tissue lesions including lung, liver, kidney and lymph nodes. The echogenic tip and graduated cannula facilitate clinical manipulation. Device must be operated by trained physicians as single-use sterile product with continuous imaging monitoring to prevent complications such as hemorrhage and pneumothorax. Store in cool, dry environment protected from light; reuse is prohibited.
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：厂家美国Argon爱琅同轴引导活检针MCXS1815BP,爱琅同轴引导活检针,爱琅活检针
