厂商COOK库克双猪尾硅胶输尿管支架133624,133626,133628
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厂商COOK库克双猪尾硅胶输尿管支架133624,133626,133628
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 双猪尾硅胶输尿管支架Black Silicone Filiｆorm Double Pigtail Ureteral Stent Set Wire Guide with Hydrophilic Coating
管理类别 第三类
型号规格 133620, 133622, 133624, 133626, 133628, 133724, 133726, 133728, 133824, 133826, 133828
结构及组成/主要组成成分 由双猪尾支架和推送器组成，不含药，经环氧乙烷灭菌，一次性使用。
适用范围/预期用途 用于输尿管肾盂连接处至膀胱的临时性内引流。
COOK 库克 双猪尾硅胶输尿管支架（133624 /133626 /133628）
注册证号：国械注进 20173140395
型号对应： 133624 6Fr‑24cm；133626 6Fr‑26cm；133628 6Fr‑28cm
1、工作原理 Working Principle
中文 支架两端为猪尾卷曲结构，一端留置肾盂内，另一端留置膀胱内，支架管腔贯通肾盂‑输尿管‑膀胱；依靠管腔通道实现尿液内引流；两端卷曲结构锚定在肾盂与膀胱，防止支架移位、滑脱；硅胶材质支撑输尿管管壁，解除输尿管梗阻，保障尿液从肾脏向膀胱持续引流，降低肾盂内压力，保护肾功能。
English Both ends of the stent adopt pigtail coiled structure. One coil is placed in renal pelvis and the other in bladder. The lumen of stent connects renal pelvis, ureter and bladder to realize internal urine drainage. The coiled ends anchor in renal pelvis and bladder to prevent stent migration or dislodgement. The silicone stent supports ureteral wall, relieves ureteral obstruction, maintains continuous urine drainage from kidney to bladder, reduces renal pelvic pressure and protects renal function.
2、产品功能 Function
中文
实现肾盂至膀胱的临时性尿液内引流；
支撑输尿管管腔，解除输尿管梗阻；
术后支撑输尿管，预防输尿管管腔粘连、狭窄；
降低肾积水，保护肾脏功能。
English
Temporary internal urine drainage from ureteropelvic junction to bladder;
Support ureteral lumen and relieve ureteral obstruction;
Support ureter after surgery, prevent ureteral adhesion and stricture;
Mitigate hydronephrosis and preserve renal function.
3、产品特点 Product Features
中文
黑色不透射线硅胶材质，X 光下显影，术中、术后可透视确认位置；
双猪尾锚定设计，降低支架上移、下移移位风险；
丝状头端，支持一步法置入，减少术中损伤；
硅胶材质生物相容性好，质地柔软，降低尿路刺激；
套装含支架、推送器，部分配置牵引线，方便后期取出；
环氧乙烷灭菌，一次性无菌使用；最大建议留置时间 12 个月，不可超期留置Cook Medic...。
English
Black radiopaque silicone material, visible under fluoroscopy for intra‑operative and post‑operative position verification;
Double‑pigtail anchoring design to reduce risk of upward / downward migration;
Filiｆorm tip enables one‑pass placement and minimizes intra‑operative trauma;
Soft silicone with good biocompatibility to reduce urinary tract irritation;
Kit includes stent and positioner; tether suture for convenient removal;
Ethylene oxide sterilized, single‑use only. Maximum recommended indwelling time: 12 months, do not exceed.
4、技术参数 Technical Specifications
中文
表格
| 项目 | 参数 |
|---|---|
| 注册证 | 国械注进 20173140395 |
| 材质 | 支架：黑色不透射线医用硅胶；推送器：聚乙烯 + 304 不锈钢头端；牵引线：聚丙烯缝线 |
| 规格 133624 | 6Fr，总长度 24cm |
| 规格 133626 | 6Fr，总长度 26cm |
| 规格 133628 | 6Fr，总长度 28cm |
| 灭菌方式 | 环氧乙烷灭菌 |
| 使用性质 | 一次性使用 |
| 最大留置周期 | ≤12 个月 |
| 组件 | 双猪尾支架、支架推送器；牵引线（随支架） |
| 产地 | 美国 Cook Urological Incorporated |
English
表格
| Item | Specifications |
|---|---|
| Registration No. | 国械注进 20173140395 |
| Material | Stent: black radiopaque medical‑grade silicone; Positioner: polyethylene with 304SS tip; Tether: polypropylene suture |
| Model 133624 | 6Fr, total length 24cm |
| Model 133626 | 6Fr, total length 26cm |
| Model 133628 | 6Fr, total length 28cm |
| Sterilization | Ethylene oxide(EO) |
| Usage | Single‑use only |
| Max indwelling duration | ≤12 months |
| Kit contents | Double‑pigtail stent, stent positioner, tether suture |
| Origin | USA, Cook Urological Incorporated |
5、使用方法 Method of Use
中文
术前依据患者输尿管解剖选择适配长度规格；
可经尿道内镜、经皮肾通路或开放手术途径置入；
沿导丝送入支架套装，使用推送器推送支架；利用丝状头端实现一步到位放置；
在 X 线透视监视下，确认支架近端猪尾卷曲于肾盂内，远端猪尾卷曲于膀胱内；
撤出推送器与导丝，确认支架位置正确；带牵引线版本将牵引线留置于膀胱内便于后期取出；
术后按计划时间，膀胱镜下取出支架；严禁超 12 个月留置Cook Medic...。
English
Select proper stent length according to patient ureter anatomy before operation.
Placement approaches: transurethral endoscopy, percutaneous nephrostomy or open surgery.
Advance stent kit over guide‑wire; deploy stent with positioner; filiｆorm tip supports one‑pass placement.
Under fluoroscopic monitoring, confirm proximal pigtail coils inside renal pelvis and distal pigtail coils within bladder.
Retract positioner and guide‑wire, verify correct stent position. For tether‑equipped version, leave tether in bladder for later removal.
Remove stent via cystoscopy at scheduled time. Do not leave indwelling over 12 months.
6、适应症 Indications
中文 用于输尿管肾盂连接处至膀胱的临时性内引流。临床适用场景包含：
输尿管结石术后，支撑输尿管、引流尿液；
良性、恶性、创伤导致的输尿管梗阻临时解除；
输尿管狭窄扩张术后支撑；
肾盂、输尿管手术术后引流保护；
缓解肾积水，保护肾功能的临时尿路引流。
English For temporary internal drainage from ureteropelvic junction to bladder. Clinical scenarios include:
Ureteral support and urine drainage after ureteral stone surgery;
Temporary relief of ureteral obstruction caused by benign, malignant or traumatic lesions;
Ureteral support after stricture dilation;
Urinary diversion and protection after renal pelvic and ureteral surgery;
Temporary urinary drainage to relieve hydronephrosis and preserve renal function.
7、禁忌症 Contraindications
中文
泌尿系统活动性感染未控制；
尿道、膀胱严重畸形，无法完成置入；
对硅胶、聚丙烯、聚乙烯等产品材质过敏；
输尿管完全闭锁，支架无法通过；
不适合体内留置异物的全身状况（如严重免疫低下、无法随访）；
不可作为长期植入物使用（本产品临时留置）。
English
Uncontrolled active urinary tract infection;
Severe deｆormity of urethra or bladder which prevents placement;
Known allergy to silicone, polypropylene, polyethylene or other device materials;
Complete ureteral atresia where stent cannot pass through;
Systemic conditions unsuitable for indwelling foreign body (e.g. severe immunodeficiency without follow‑up capability);
Not for permanent implantation; only for temporary indwelling.
8、注意事项 Precautions
中文
本产品一次性使用，灭菌包装破损、过期禁止使用；
支架最大留置时间不超过 12 个月，必须按时取出或更换，超期留置会增加钙化、结石、断裂风险；
术中全程透视确认支架两端猪尾分别盘在肾盂、膀胱，避免支架移位；
留置期间定期影像学随访，评估支架位置、有无钙化、结石、断裂；
术后告知患者血尿、尿频尿急、腰部酸胀为支架常见刺激症状，严重不适及时就诊；
牵引线不可暴力牵拉，防止断裂残留；
仅由受过泌尿外科介入操作培训医师操作；
如发生支架断裂、移位，需内镜或手术取出；
不可用于适应症以外其他用途。
English
Single‑use only. Do not use if sterile package is damaged or expired.
Maximum indwelling time shall not exceed 12 months. Stent must be removed or replaced on schedule. Prolonged indwelling increases risks of encrustation, stone ｆormation and stent fracture.
Intra‑operative fluoroscopy is mandatory to confirm both pigtails correctly coiled in renal pelvis and bladder to avoid migration.
Regular imaging follow‑up during indwelling period to check stent position, encrustation, stone and fracture.
Inｆorm patient that hematuria, frequency‑urgency and flank discomfort are common stent‑related irritative symptoms; seek medical help for severe symptoms.
Do not pull tether with excessive force to prevent breakage and residual fragment.
Device shall only be operated by physicians trained in urological interventional procedures.
In case of stent fracture or migration, retrieve by endoscopy or surgery.
Do not use for purposes outside approved indications.
9、存储条件 Storage Conditions
中文
存放于干燥、阴凉环境，避免阳光直射；
环境温度：5℃‑30℃，避免高温、冷冻；
远离潮湿、腐蚀性气体；
原包装保存，勿挤压、撞击包装，防止无菌屏障破损；
在产品有效期内使用。
English
Store in cool and dry place, avoid direct sunlight.
Ambient temperature: 5℃‑30℃. Avoid high temperature and freezing.
Keep away from moisture and corrosive gas.
Keep in original package; avoid compression or impact to preserve sterile barrier.
Use within product expiry date.
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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