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上海康世达医疗器械有限公司 主营产品:医用体检,诊断,急救,化验,超声,医学分析,生命科学,消毒灭菌,康复治疗,手术室,急救室,诊疗室等设备,一类医疗器械,二类医疗器械,三类医疗器械,IVD及消毒器具耗材

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厂商直销Cook库克栓塞弹簧圈IMWCE‑35‑20‑20

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品牌名称:$brandModel.Title型号: 原产地:中国大陆 医疗器械注册号(批文):国械注进20143136246更新时间:2026/10/16 11:11:09

产品摘要:厂商直销Cook库克栓塞弹簧圈IMWCE‑35‑20‑20

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厂商直销Cook库克栓塞弹簧圈IMWCE‑35‑20‑20

桂经理19117326863微xin同号

桂经理19117326863微xin同号

产品名称 栓塞弹簧圈Embolization Coil

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 该产品由弹簧圈和装载筒组成。弹簧圈由铬镍铁合金和人造纤毛(尼龙6,6)制成。产品环氧乙烷灭菌,一次性使用。货架有效期五年。

适用范围/预期用途 栓塞弹簧圈预期用于外周动脉和静脉血管的栓塞治疗。

1、产品工作原理 Working Principle

中文:该弹簧圈由铂钨合金丝缠绕成型,附带尼龙 66 合成纤维毛;在 DSA 透视监视下,经导管输送至靶血管 / 病变腔内,释放后弹簧圈恢复预设卷曲形态,依靠机械物理填塞占位;纤维毛可吸附血液内血小板、纤维蛋白,诱导局部血栓形成,最终实现病变血管腔闭塞,阻断异常血流,达到栓塞治疗目的。 English:The coil is wound from platinum‑tungsten alloy wire with nylon‑66 synthetic fibrous bristles. Under DSA fluoroscopic monitoring, it is delivered through catheter to target vessel or lesion cavity. After deployment, the coil restores its preset coiled shape for mechanical physical packing. The fibrous bristles adsorb platelets and fibrin in blood to induce local thrombosis, occlude the pathological vascular lumen, block abnormal blood flow and achieve embolization therapy。

2、产品功能 Product Function

中文:介入手术中对病变血管进行腔内机械栓塞,填塞血管畸形、异常血管腔,阻断血流,实现血管闭塞,用于介入栓塞治疗。 English:Intraluminal mechanical embolization of pathological vessels during interventional procedures, packing vascular malformations and abnormal vascular lumens to block blood flow and accomplish vascular occlusion for interventional embolization therapy.

3、产品特点 Product Features

中文

  1. 铂钨合金材质,X 线下显影清晰,兼容核磁检查;

  2. 预置尼龙 66 纤维毛,加速血栓形成,提升栓塞效率;

  3. 0.035 英寸输送系统适配,柔顺性好,可贴合血管腔形态;

  4. 预成型卷曲结构,释放形态稳定,降低移位风险;

  5. 环氧乙烷灭菌,一次性使用,避免交叉感染。

English

  1. Platinum‑tungsten alloy material with clear X‑ray visualization and MRI compatibility.

  2. Pre‑attached nylon‑66 fibrous bristles accelerate thrombosis and improve embolization efficiency.

  3. Compatible with 0.035 inch delivery system, good flexibility to conform to vessel lumen geometry.

  4. Pre‑formed coiled structure for stable deployed shape and reduced migration risk.

  5. Ethylene oxide sterilized, single‑use only to avoid cross‑infection.

4、技术参数 Technical Parameters

中文 - 型号:IMWCE‑35‑20‑20 - 推送导管适配:0.035 英寸系统 - 弹簧圈卷曲直径:20 mm - 弹簧圈有效栓塞长度:20 cm - 主体材质:铂钨合金 - 纤维材质:尼龙 66 - 灭菌方式:环氧乙烷 EO 灭菌 - 使用方式:一次性使用 - 货架有效期:5 年 - 产品类别:Ⅲ 类医疗器械

English ‑Model:IMWCE‑35‑20‑20 ‑Compatible delivery catheter:0.035‑inch system ‑Coil coiled diameter:20 mm ‑Effective embolic length:20 cm ‑Main material:Platinum‑tungsten alloy ‑Fiber material:Nylon‑66 ‑Sterilization:Ethylene oxide (EO) ‑Usage:Single‑use only ‑Shelf‑life:5 years ‑Device class:Class Ⅲ medical device

5、使用方法 Operation Method

中文 1. 术前确认包装完好、在有效期内,拆开无菌包装取出产品; 2. 在 DSA 透视监视下,将适配的输送导管放置至靶血管目标位置; 3. 将弹簧圈装载入输送导管,借助推送器械沿导管推送弹簧圈; 4. 透视下确认弹簧圈到达靶区,逐步推送释放弹簧圈,观察弹簧圈卷曲成型状态; 5. 确认弹簧圈完全释放、位置符合临床要求,撤出推送器械与导管; 6. 按照临床介入操作规范完成后续手术流程;本品为一次性耗材,使用后废弃,严禁重复使用。

English 1.Verify intact package and valid shelf‑life before procedure, open sterile package and take out product. 2.Under DSA fluoroscopy, place compatible delivery catheter at target site of lesion vessel. 3.Load embolization coil into delivery catheter, advance coil with pusher device through catheter lumen. 4.Confirm coil reaches target position under fluoroscopy, advance gradually to deploy coil and observe coiled conformation. 5.After full deployment with clinically satisfactory position, withdraw pusher and catheter. 6.Complete subsequent interventional steps per clinical protocol. Single‑use device, discard after use, re‑use is strictly prohibited.

6、适应症 Indications

中文:在荧光透视监视下,经导管介入方式,用于动静脉血管畸形、外周血管病变的介入栓塞治疗。 English:For transcatheter interventional embolization treatment of arteriovenous vascular malformations and peripheral vascular lesions under fluoroscopic monitoring。

7、禁忌症 Contraindications

中文 1. 靶血管解剖不适合弹簧圈栓塞; 2. 血管存在严重痉挛、闭塞,导管无法抵达靶位; 3. 对铂钨合金、尼龙材料过敏患者; 4. 存在活动性严重感染、败血症未控制; 5. 患者不能耐受介入造影手术。

English 1.Target vessel anatomy not suitable for coil embolization. 2.Severe vasospasm or occlusion preventing catheter access to target site. 3.Patient allergy to platinum‑tungsten alloy or nylon materials. 4.Uncontrolled severe active infection or sepsis. 5.Patient cannot tolerate interventional angiography procedure.

8、注意事项 Precautions

中文 1. 仅可由经过介入放射专科培训医师操作; 2. 仅一次性使用,包装破损、过期禁止使用; 3. 全程 DSA 透视监视释放,警惕弹簧圈移位、异位栓塞风险; 4. 释放过程避免暴力推送,防止导管损伤血管内壁; 5. 弹簧圈释放后需造影复查栓塞效果; 6. 术后监测有无出血、血管损伤、异位栓塞等并发症; 7. 不可用于血管远端正常血管的非治疗性栓塞; 8. 废弃产品按医疗废弃物规范处置。

English 1.Operation shall only be performed by physicians trained in interventional radiology. 2.Single‑use only. Do not use if package damaged or expired. 3.Deploy under continuous DSA fluoroscopy to guard against coil migration and non‑target embolization. 4.Avoid forceful advancement during deployment to prevent vessel wall injury. 5.Perform post‑deployment angiography to verify embolization outcome. 6.Monitor post‑procedure complications including hemorrhage, vessel injury and non‑target embolization. 7.Do not perform non‑therapeutic embolization on normal distal vessels. 8.Dispose used product in accordance with medical waste regulations.

9、存储条件 Storage Conditions

中文:储存于阴凉干燥环境,避免阳光直射、高温、潮湿;远离腐蚀性气体;温度 5‑30℃,相对湿度 30%‑75%;禁止重压、摔砸包装;按无菌耗材储存管理。 English:Store in cool and dry environment, avoid direct sunlight, high temperature and humidity, keep away from corrosive gas. Storage temperature 5‑30℃, relative humidity 30%‑75%. Avoid heavy compression and impact on package. Manage as sterile medical consumable.

10、说明书核心摘要 Core Summary

中文:库克 IMWCE‑35‑20‑20 栓塞弹簧圈为 Ⅲ 类一次性介入栓塞耗材,铂钨合金带尼龙纤维毛,0.035 英寸输送系统,卷曲直径 20mm,有效栓塞长度 20cm;DSA 透视下经导管送入靶血管释放,依靠物理填塞 + 诱导血栓实现血管闭塞,用于动静脉血管畸形、外周血管病变介入栓塞;一次性 EO 灭菌,5 年有效期;禁忌材料过敏、靶血管解剖不适合栓塞;操作全程透视,防范异位栓塞,阴凉干燥避光储存。 English:Cook IMWCE‑35‑20‑20 embolization coil is Class‑Ⅲ single‑use interventional embolic device, platinum‑tungsten alloy with nylon fibrous bristles, compatible with 0.035‑inch delivery system, coiled diameter 20 mm, effective embolic length 20 cm. It is delivered and deployed via catheter under DSA fluoroscopy, achieves vascular occlusion by mechanical packing and induced thrombosis, indicated for interventional embolization of arteriovenous malformations and peripheral vascular lesions. EO sterilized single‑use device with 5‑year shelf‑life. Contraindicated for material allergy and anatomically‑unsuitable target vessels. Deploy under full fluoroscopic monitoring to prevent non‑target embolization. Store in cool, dry and light‑proof environment.

免责声明: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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