厂商先瑞达外周血栓抽吸导管AC6FD,AC4FD,AC8FE
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厂商先瑞达外周血栓抽吸导管AC6FD,AC4FD,AC8FE
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称
外周血栓抽吸导管
管理类别
第三类
型号规格
见附页
结构及组成/主要组成成分
该产品由外周血栓抽吸导管、保护套、止血阀和塑形杆组成。环氧乙烷灭菌，一次性使用，货架有效期3年
适用范围/预期用途
适用于去除外周血管系统中的血栓。
型号说明：AC4FD：4F 规格；AC6FD：6F 规格；AC8FE：8F 规格；D/E 代表长度系列，适配下肢动脉、髂静脉、膝下血管等不同外周血管通路
一、工作原理 Working Principle
中文产品为单腔大内腔介入导管，在数字减影血管造影（DSA）透视引导下，沿导丝送达外周血管血栓病变部位；导管尾端外接负压抽吸系统（负压泵 / 负压注射器），利用流体负压效应，将新鲜、亚急性血栓、栓子经导管内腔抽吸至体外，实现机械性血栓清除，开通闭塞血管。导管采用多层复合编织结构，耐受负压不塌陷；头端显影标记辅助定位抽吸口，定向清除血管腔内血栓。
EnglishThis single-lumen large-bore interventional catheter is delivered over a guidewire to the thrombotic lesion of peripheral vessels under DSA fluoroscopy. The catheter hub is connected to a negative pressure aspiration system (vacuum pump or aspiration syringe). Via fluid negative pressure, fresh and subacute thrombi and emboli are aspirated out of the body through the catheter lumen to mechanically remove thrombus and recanalize occluded vessels.Multi-ｌayer composite braided construction prevents catheter collapse under negative pressure. Radiopaque markers at the tip enable precise positioning of the aspiration port for targeted clot removal.
二、产品功能 Functions
中文
DSA 透视下，对外周血管内新鲜 / 亚急性血栓实施负压抽吸清除；
大内腔通路，保证稳定抽吸流量，高效移除血管腔内栓子；
头端双显影环，术中实时判断导管头端位置与抽吸开口朝向；
渐变硬度管身，兼顾远端柔顺性与近端推送支撑力，通过迂曲血管；
兼容专用负压抽吸泵、大容量负压注射器两种抽吸方案；
一次性无菌使用，配套塑形杆、止血阀，方便术中管路建立。
English
Perｆorm negative-pressure aspiration to remove fresh / subacute thrombus in peripheral vessels under DSA guidance;
Large inner lumen ensures stable aspiration flow for efficient embolus extraction;
Dual radiopaque tip markers to identify catheter position and aspiration port orientation intraoperatively;
Variable stiffness shaft balances distal flexibility and proximal pushability to navigate tortuous vasculature;
Compatible with dedicated vacuum aspiration pump and large-volume aspiration syringe;
Single-use sterile device, supplied with shaping mandrel and hemostatic valve for convenient intraoperative setup.
三、产品特点 Product Features
中文
皮薄大内腔设计：同等外径下最大化内腔面积，提升抽吸效率，抗负压塌陷；
梯度硬度复合编织管身：远端柔软，降低血管内皮损伤风险；近端支撑优良，推送、扭控性能；
远端亲水涂层：减少导管与血管壁摩擦，降低血管痉挛风险；
头端圆滑无锐边，防止划伤血管内膜；多规格型号（4F/6F/8F）覆盖膝下、股腘、髂动静脉等不同血管尺寸；
显影标记清晰，透视下定位直观，便于靶向抽吸附壁血栓；
全套环氧乙烷灭菌，独立无菌包装；
适配标准 0.018"/ 0.035" 临床常用导丝通路；
型号丰富：AC4FD 细管径适合膝下小血管；AC6FD 通用主力型号；AC8FE 大内腔适合髂股静脉、大块血栓负荷。
English
Thin-wall large-lumen design maximizes inner bore area under same outer diameter, improves aspiration efficiency and resists collapse under vacuum;
Variable stiffness composite braided shaft: soft distal segment reduces endothelial injury; stiff proximal section provides excellent pushability and torque response;
Distal hydrophilic coating minimizes friction between catheter and vessel wall to reduce vasospasm;
Atraumatic rounded tip prevents intimal laceration; multiple sizes (4F/6F/8F) fit infrapopliteal, femoropopliteal, iliac arterial and venous vessels;
Clear radiopaque markers enable intuitive fluoroscopic positioning for targeted aspiration of mural thrombus;
Ethylene oxide (EO) sterilized, individually sterile packaged;
Compatible with widely used 0.018" / 0.035" guidewires;
Diversified portfolio: AC4FD for small infrapopliteal vessels; AC6FD general-purpose model; AC8FE large lumen for iliofemoral veins and high thrombus burden.
四、技术参数 Technical Specifications
| 中文 | English |
|---|---|
| 产品名称：外周血栓抽吸导管 | Product Name: Peripheral Thrombus Aspiration Catheter |
| 型号：AC4FD / AC6FD / AC8FE | Model: AC4FD / AC6FD / AC8FE |
| 灭菌方式：环氧乙烷（EO） | Sterilization: Ethylene Oxide (EO) |
| 使用方式：一次性使用，不可重复灭菌复用 | Application: Single use only, resterilization prohibited |
| AC4FD：4F 外径，适配 0.018" 导丝 | AC4FD: 4Fr OD, compatible with 0.018” guidewire |
| AC6FD：6F 外径，适配 0.035" 导丝 | AC6FD: 6Fr OD, compatible with 0.035” guidewire |
| AC8FE：8F 外径，适配 0.035" 导丝 | AC8FE: 8Fr OD, compatible with 0.035” guidewire |
| 导管材质：Pebax、镍钛编织、亲水涂层 | Material: Pebax, Nitinol braid, hydrophilic coating |
| 有效工作长度：FD/FE 系列 90cm/120cm/135cm 可选 | Working Length: 90cm / 120cm / 135cm available for FD/FE series |
| 适用操作环境：DSA 介入手术室 | Operation Environment: DSA interventional cath lab |
| 货架有效期：3 年 | Shelf Life: 3 years |
五、使用方法 Operation Instructions
中文
术前核查包装完整性、灭菌有效期，在无菌台拆开外包装；取出导管、塑形杆、止血阀组件。
肝素生理盐水冲洗导管内腔，充分润湿远端亲水涂层，排尽管内空气。
建立血管入路，置入血管鞘，沿导丝将抽吸导管输送至血栓病变近端（全程 DSA 透视监测）。
导管尾端连接止血阀与负压抽吸系统（抽吸泵或负压注射器），建立密闭负压通路。
透视下缓慢推送导管头端抵达血栓区域，开启负压，缓慢前后移动导管实施血栓抽吸；若导管堵塞，保持负压撤出体外冲洗。
阶段性造影评估血栓清除效果，重复抽吸直至血栓负荷满意。
抽吸完成后维持负压状态缓慢回撤导管至血管鞘内，撤出体外；再次造影评估血管通畅情况。
整套器械术后按医疗感染性废弃物规范处置。
English
Verify package integrity and expiry date before procedure. Open outer package under sterile conditions; retrieve catheter, shaping mandrel and hemostatic valve.
Flush catheter lumen with heparinized saline, activate distal hydrophilic coating and purge air inside lumen.
Establish vascular access and insert sheath. Advance aspiration catheter over guidewire to proximal thrombus under continuous DSA fluoroscopy.
Connect catheter hub with hemostatic valve and negative pressure system (vacuum pump or aspiration syringe) to ｆorm sealed aspiration circuit.
Advance catheter tip slowly to thrombus under fluoroscopy, activate vacuum, withdraw and advance catheter gently to perｆorm aspiration. If occlusion occurs, remove catheter under sustained negative pressure for irrigation.
Perｆorm sequential angiography to evaluate clot burden, repeat aspiration until satisfactory thrombus removal.
Retract catheter slowly into sheath under maintained negative pressure after aspiration, then remove from patient. Final angiography to assess vessel patency.
Dispose all devices as regulated biohazard medical waste after use.
六、适应症 Indications
中文适用于外周血管系统新鲜、亚急性血栓 / 栓子的抽吸清除，包括：
下肢动脉急性肢体缺血，动脉血栓、栓塞病变；
髂静脉、股静脉、腘静脉深静脉血栓（DVT）；
上肢动、静脉血栓闭塞；
外周血管介入术中脱落栓子的应急抽吸；外周血管，不适用于冠状动脉、颅内脑血管。
EnglishIntended for aspiration and removal of fresh and subacute thrombi / emboli within the peripheral vasculature:
Acute limb ischemia caused by lower-extremity arterial thrombosis or embolism;
Deep venous thrombosis (DVT) of iliac, femoral and popliteal veins;
Upper extremity arterial and venous thrombotic occlusion;
Emergency aspiration of emboli dislodged during peripheral endovascular procedures.For peripheral vasculature only. Not indicated for coronary or intracranial cerebrovascular vessels.
七、禁忌症 Contraindications
中文
机化陈旧性血栓，无法单纯依靠负压抽吸清除；
严重血管钙化、重度狭窄，导管无法安全抵达血栓病变区域；
目标血管存在动脉瘤、血管壁破裂风险；
无法耐受抗凝、介入手术的严重全身基础疾病；
对导管材料、肝素、造影剂存在严重过敏；
妊娠患者、无法配合放射介入操作；
感染性血栓、脓毒性血栓（感染性静脉炎）。
English
Organized chronic thrombus which cannot be removed merely by vacuum aspiration;
Severe vascular calcification or critical stenosis preventing safe catheter access to lesion;
Target vessel aneurysm or risk of vessel wall rupture;
Severe systemic disease precluding anticoagulation and endovascular intervention;
Severe allergy to catheter materials, heparin or contrast medium;
Pregnant patients or patients unable to tolerate fluoroscopic intervention;
Septic thrombus / septic phlebitis.
八、注意事项 Precautions
中文
必须由接受外周介入正规培训医师，在 DSA 透视监控下操作；禁止盲视推送导管。
严禁向血管内冲洗抽吸导管，避免管腔内血栓被冲入远端造成异位栓塞。
抽吸过程密切监测患者生命体征、血管造影影像，警惕远端栓塞、血管痉挛、内膜撕裂。
控制负压大小，过高负压可能诱发血管塌陷、内皮损伤、溶血。
导管出现扭折、破损、渗漏时，立即停止使用；禁止体外暴力弯折导管。
一次性使用，严禁重复使用、二次灭菌。
术中足量肝素化抗凝，降低新血栓形成风险；监测 ACT。
若抽吸无回血，提示导管堵塞，保持负压整体撤出，不可在体内拆卸管路。
不要强行推送导管对抗明显阻力，防止导管变形、血管穿孔。
English
Operation must be perｆormed by physicians ｆormally trained in peripheral endovascular techniques under continuous DSA fluoroscopy. Blind advancement is prohibited.
Never flush aspiration catheter inside vessel; avoid pushing trapped thrombus distally leading to distal embolization.
Closely monitor patient vital signs and angiographic images during aspiration to guard against distal embolism, vasospasm and intimal dissection.
Regulate negative pressure; excessive vacuum may cause vessel collapse, endothelial injury and hemolysis.
Immediately discontinue use if kinking, damage or leakage occurs. Do not bend catheter violently outside body.
Single-use device. Reuse and resterilization are strictly forbidden.
Maintain adequate heparinization intraoperatively to reduce de novo thrombosis risk; monitor ACT.
Absence of blood return indicates catheter occlusion. Remove entire catheter under sustained vacuum; do not disconnect circuit in vivo.
Do not advance catheter against significant resistance to prevent catheter deｆormation and vessel perforation.
九、存储条件 Storage Conditions
中文储存环境温度：5℃ ~ 40℃；相对湿度：30%～80%，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；产品保持原装包装完整平放或直立存放；禁止冷冻。货架有效期 3 年，超过有效期禁止使用。
EnglishStorage Temperature: 5℃ ~ 40℃;Relative Humidity: 30%～80%, no condensation;Requirements: Dry, ventilated and dust-free; avoid direct sunlight, heavy pressure and impact; keep away from corrosive gas and organic solvents.Store in intact original package horizontally or vertically. Freezing is prohibited.Shelf life: 3 years. Do not use after expiry date.
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.
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