厂商直供麦瑞通微导管28MC24150SN,29MC29150SN
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厂商直供麦瑞通微导管28MC24150SN,29MC29150SN
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第三类
型号规格
28MC24110ST，28MC24130ST，28MC24150ST，28MC2411045，28MC2413045，28MC2415045，28MC24110SN，28MC24130SN，28MC24150SN，28MC28110ST，28MC28130ST，28MC28150ST，28MC2811045，28MC2813045，28MC2815045，28MC28110SN，28MC28130SN，28MC28150SN，29MC29110ST，29MC29130ST，29MC29150ST，29MC2911045，29MC2913045，29MC2915045，29MC29110SN，29MC29130SN，29MC29150SN。
结构及组成/主要组成成分
该产品主要由导管座、轴衬、导管轴、矫直器及注射器组成。其中导管轴内层为聚四氟乙烯组成；导管轴外层近端部分主要由尼龙12组成，远端部分主要由Pebax 2533SA01组成；导管头端有铂标记带，远端前80cm涂覆有亲水涂层。注射器由聚碳酸酯、硅胶、ABS树脂等组成。一次性使用，环氧乙烷灭菌，有效期三年。
适用范围/预期用途
该产品适用于一般血管内，包括外围和冠状动脉血管系统，一旦进入超选择性部位，微导管可用于控制性和选择性地输注诊断性、栓塞性或治疗性的材料进入血管内。导管不应被用于大脑血管内。
产品储存条件及有效期
1 工作原理 Working Principle
中文在导丝导引下，微导管经由导引导管输送至外周 / 冠状动脉超选靶血管；导管内部聚四氟乙烯内衬建立通畅输送通道；远端亲水涂层提升在迂曲血管内推送、跟踪性能；头端铂显影标记在透视下定位导管头端位置；天鹅颈预塑形头端实现血管内锚定，降低栓塞材料推注时导管回弹；通过导管管腔可控、选择性向靶血管输注造影剂、栓塞材料或治疗药剂，实现靶血管局部给药与栓塞治疗Merit Medi...。
EnglishUnder the guidance of guide‑wire, the microcatheter is advanced through guiding catheter to sub‑selective target vessels of peripheral or coronary circulation. PTFE inner liner creates a smooth delivery lumen. Distal hydrophilic coating enhances push‑ability and track‑ability within tortuous vasculature. Platinum radiopaque marker enables fluoroscopic tip localization. Pre‑shaped swan‑neck tip provides vessel seating and reduces catheter recoil during embolic injection. Through the inner lumen, diagnostic contrast media, embolic agents or therapeutic drugs can be delivered in controlled, selective fashion to target vascular territoryFDA Access...。
2 产品功能 Product Function
中文
在透视下完成外周血管、冠状动脉系统的超选择性血管插管；
选择性、可控输注诊断造影介质；
输送弹簧圈、颗粒等栓塞材料实施血管栓塞；
输注化疗、硬化等治疗性药剂；
天鹅颈头端构型减少推注过程导管反弹移位，稳定给药位置。
禁止用于脑血管系统。
English
Perｆorm sub‑selective catheterization for peripheral and coronary vasculature under fluoroscopy.
Deliver diagnostic contrast media selectively and controllably.
Deploy embolic materials including coils and particles for vascular embolization.
Infuse therapeutic agents such as chemotherapeutic or sclerosant drugs.
Swan‑neck tip configuration minimizes catheter recoil and displacement during injection, stabilizing delivery position.
Not intended for cerebral vasculature use。
3 产品特点 Product Features
中文
天鹅颈 (Swan‑Neck) 预塑形头端：次级弯曲实现血管内锚定，降低栓塞剂推注时导管回弹移位；
远端 80cm 亲水涂层，提升迂曲血管跟踪顺滑度；
20cm 柔性远端段，降低血管内皮损伤风险；
尼龙编织管身，兼顾推送力、跟踪性、抗扭折；
头端铂不透射线标记带，透视下清晰识别头端位置；
管座材料兼容碘油、DMSO、化疗药、血管硬化胶、乙醇等介入制剂；
PTFE 光滑内衬，便于导丝、栓塞材料通过；
一次性环氧乙烷灭菌，配套矫直器、3mL 注射器 2 支Merit Medi...。
English
Pre‑shaped Swan‑Neck tip: secondary curve provides vessel seating and reduces catheter recoil during embolic injection.
Hydrophilic coating over distal 80 cm shaft for smooth navigation in tortuous anatomy.
20 cm flexible distal segment to reduce risk of vascular intimal injury.
Nylon‑braided shaft balances push‑ability, track‑ability and kink‑resistance.
Distal platinum radiopaque marker band for clear fluoroscopic tip visualization.
Hub material compatible with lipiodol, DMSO, chemotherapeutics, tissue glues and ethanol.
Smooth PTFE inner liner facilitates passage of guide‑wire and embolic devices.
Single‑use, ethylene‑oxide sterilized; supplied with tip straightener and two 3 mL syringesMerit Medi...。
4 技术参数 Technical Specifications
表格
| 项目 | 28MC24150SN | 29MC29150SN |
|---|---|---|
| 中文型号 | 28MC24150SN | 29MC29150SN |
| Catalog No. | 28MC24150SN | 29MC29150SN |
| 头端构型 Tip Shape | Swan‑Neck 天鹅颈 | Swan‑Neck 天鹅颈 |
| 有效工作长度 Working Length | 150 cm | 150 cm |
| 近端外径 Proximal OD | 2.8 F | 2.9 F |
| 远端外径 Distal OD | 2.4 F | 2.9 F |
| 管腔内径 Inner Lumen ID | 0.020" (0.52 mm) | 0.020" (0.52 mm) |
| 最大兼容导丝 Max compatible guide‑wire | 0.018" (0.46 mm) | 0.018" (0.46 mm) |
| 亲水涂层长度 Hydrophilic coating length | 80 cm | 80 cm |
| 标记带距头端 Marker‑to‑tip distance | 1.3 mm | 1.3 mm |
| 最小导引导管内径 Min guiding catheter ID | 0.040" (1.02 mm) | 0.040" (1.02 mm) |
| 可输送最大颗粒 Max embolic particle | 900 µm | 900 µm |
| 灭菌方式 | 环氧乙烷 Ethylene oxide | 环氧乙烷 Ethylene oxide |
| 使用属性 | 一次性 Single‑use only | 一次性 Single‑use only |
| 货架有效期 Shelf‑life | 3 年 3 years | 3 年 3 years |
管身材质：内层 PTFE 聚四氟乙烯；近端外层尼龙 12；远端外层 Pebax；头端铂标记带。
5 使用方法 Instructions for Use
中文
按介入标准技术置入合适的导引导管，可连接旋转止血阀，肝素生理盐水持续冲洗导引导管；
无菌条件打开包装，取出微导管与矫直器；天鹅颈头端需使用配套矫直器将头端矫直，便于导入导引导管；
使用肝素生理盐水 / 无菌水充分润湿微导管全部外表面，激活亲水涂层；
微导管座连接注射器，充分排气，排尽管腔内空气；
在透视监视下，导丝先行，将微导管沿导丝推送，经导引导管到达靶血管超选位置；
确认头端位置，撤出导丝；连接给药注射器，在透视下可控推注造影剂确认位置，之后输注栓塞或治疗材料；
完成操作后，透视监视下轻柔撤出微导管；
本品一次性使用，使用后废弃，严禁重复灭菌复用。
重要：亲水涂层干燥后会失效，操作过程需要保持导管表面湿润Merit Medi...。
English
Place appropriate guiding catheter per standard interventional technique. Rotating hemostasis valve may be connected for continuous heparinized saline flush.
Open package under sterile conditions; retrieve microcatheter and tip straightener. Use straightener for swan‑neck tip before introducing into guiding catheter.
Fully wet entire outer surface with heparinized saline or sterile water to activate hydrophilic coating.
Attach syringe to microcatheter hub, purge all air from inner lumen.
Under fluoroscopic guidance, advance microcatheter over guide‑wire through guiding catheter to desired sub‑selective target position.
Confirm tip position fluoroscopically, remove guide‑wire. Connect delivery syringe, inject contrast under fluoroscopy to verify position before injecting embolic or therapeutic agents.
Upon completion of procedure, gently withdraw microcatheter under fluoroscopic monitoring.
For single‑use only. Discard after use; re‑sterilization and reuse are prohibited.
Note: Keep catheter surface continuously moist; hydrophilic perｆormance degrades upon dryingMerit Medi...。
6 适应症 Indications
中文适用于一般血管内介入操作，包含外周血管、冠状动脉血管系统；当微导管头端到达超选择性靶血管部位后，用于可控、选择性向血管内输注诊断性介质、栓塞材料或治疗性材料。本品不可用于脑血管系统。
EnglishFor general intravascular use including peripheral and coronary vasculature. Once sub‑selective vascular access is achieved, the microcatheter is intended for controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. Not for use in cerebral vasculatureFDA Access...。
7 禁忌症 Contraindications
中文
禁止用于脑血管介入；
靶血管严重痉挛、完全闭塞无法建立通路；
已知对产品材质（PTFE、尼龙、Pebax、铂、注射器高分子材料）过敏；
患者存在血管解剖不允许微导管安全到达靶位；
活动性全身感染、败血症未得到控制；
介入操作禁忌的临床状态（严重凝血障碍未纠正等）。
English
Contraindicated for cerebral vasculature application.
Target vessel with severe spasm or total occlusion where safe access cannot be established.
Known hypersensitivity to device materials (PTFE, Nylon‑12, Pebax, platinum, syringe polymers).
Vascular anatomy prevents safe advancement to target site.
Uncontrolled active systemic infection or sepsis.
Clinical contra‑indications for endovascular intervention such as uncorrected severe coagulopathy.
8 注意事项 Precautions / Warnings
中文
经过血管介入培训医师，在具备透视设备的手术室使用；
一次性使用，严禁重复使用、重复灭菌，重复使用会导致断裂、涂层失效、感染风险；
使用前检查包装完整性，包装破损、过期禁止使用；
亲水涂层必须充分润湿；干燥状态推送会损伤血管与涂层；
推送、回撤全程必须透视监控，禁止暴力推送，防止导管扭折、血管夹层、穿孔；
天鹅颈构型头端，进入导引导管前必须使用矫直器，不可强行推送预塑形弯段；
推注栓塞材料控制压力，避免反流造成非靶血管栓塞；
不可用于脑血管；
导管不得承受扭曲、过度牵拉，防止管身断裂；
与药物 / 栓塞材料配伍前确认化学相容性，不相容制剂会损伤导管；
操作全程肝素化抗凝，降低血栓风险；
若导管出现扭折，不要继续推送，轻柔回撤评估，必要时整体撤出。
English
To be used only by physicians trained in endovascular interventions in fluoroscopy‑equipped operating room.
Single‑use only. Re‑use or re‑sterilization is strictly prohibited, which may cause shaft fracture, coating failure and infection.
Inspect package before use. Do not use if package damaged or expired.
Hydrophilic coating shall be fully activated by wetting. Advancement in dry condition may damage vessel wall and coating.
All advancement and withdrawal must be perｆormed under fluoroscopy. Never apply excessive force to avoid kinking, dissection or vessel perforation.
For swan‑neck tip, apply tip straightener prior to introduction into guiding catheter; never force pre‑ｆormed curve through guiding lumen.
Control injection pressure during embolic delivery to prevent reflux and non‑target embolization.
Device shall NOT be used in cerebral vessels.
Avoid excessive torsion or tension to prevent shaft fracture.
Verify chemical compatibility before administration of drugs or embolic agents; incompatible agents may damage catheter shaft.
Maintain adequate systemic heparinization throughout procedure to reduce thrombotic risk.
If kinking occurs, stop advancing, withdraw gently under fluoroscopy and remove device as needed.
9 存储条件 Storage Condition
中文
储存环境：温度 5‑40℃；避免极端高温低温；
干燥通风，避免阳光直射、远离辐射源；
禁止重压、弯折产品外包装，防止内部导管变形；
在原始无菌包装内储存；
货架有效期 3 年，以包装上失效日期为准，过期禁用；
运输条件同储存条件。
English
Storage temperature: 5‑40 °C. Avoid extreme high / low temperature.
Store in dry and ventilated environment; keep away from direct sunlight and radiation source.
Do not apply heavy compression or bending to outer package to prevent deｆormation of inner microcatheter.
Keep stored within original sterile packaging.
Shelf‑life 3 years. Observe expiration date printed on package. Do not use expired device.
Transport under same environmental condition as storage.
10 说明书核心摘要 Core IFU Summary
中文
产品：麦瑞通 Maestro 微导管，型号 28MC24150SN、29MC29150SN；天鹅颈预塑形头端；150cm 工作长度；环氧乙烷灭菌、一次性使用；有效期 3 年。
核心用途：外周、冠脉血管超选插管，输注造影、栓塞、治疗药剂；严禁脑血管使用。
关键操作要点：①无菌开包；②使用矫直器处理天鹅颈头端；③充分润湿激活亲水涂层；④全程透视；⑤导丝引导输送；⑥排尽管腔空气；⑦可控压力给药；⑧术后轻柔撤出；一次性废弃。
主要风险：血管夹层 / 穿孔、非靶栓塞、导管扭折断裂、血栓、过敏。
储存：5‑40℃干燥避光，原始包装保存，勿挤压。
注册人：Merit Medical Systems, Inc（美国）
English Core Summary
Product: Merit Maestro Microcatheter, model 28MC24150SN / 29MC29150SN, pre‑shaped swan‑neck tip, 150 cm working length. EO sterilized, single‑use only, shelf‑life 3 years.
Intended use: sub‑selective catheterization for peripheral and coronary vasculature for delivery of contrast, embolic and therapeutic agents. NOT for cerebral vessels.
Key procedural points: sterile handling; apply tip straightener for swan‑neck tip; fully activate hydrophilic coating; continuous fluoroscopic monitoring; over‑the‑wire advancement; air‑purging of lumen; controlled‑pressure injection; gentle withdrawal after procedure; discard after single use.
Potential hazards: vessel dissection/perforation, non‑target embolization, catheter kink/fracture, thrombosis, hypersensitivity.
Storage: 5‑40 °C, dry, protected from light, in original packaging, avoid compression.
Manufacturer: Merit Medical Systems, Inc. USA. Domestic authorized agent: Merit Medical (Beijing) Co., Ltd.
以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理！The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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