厂商供应波科输尿管支架025‑0626,025‑0726,025‑0628
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厂商供应波科输尿管支架025‑0626,025‑0726,025‑0628
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 输尿管支架Polaris Loop Ureteral Stent
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 输尿管支架是一个单独的猪尾管支架，采用固定膀胱的设计（两个圆环）。该支架有一个附着的取回线和一个环形定位器。包装内包括输尿管支架、环形定位器和猪尾管直管器，输尿管支架带有HydroPlus亲水涂层。本产品经环氧乙烷灭菌，仅供一次性使用。货架有效期为三年。
适用范围/预期用途 输尿管支架适用于由一名接受过培训的医生在内窥镜下或荧光透视下放置，或者在开放式手术期间放置，促进从肾脏到膀胱的引流。
产品全称：Contour 系列输尿管支架（双猪尾），注册证：国械注进 20153142380，材质 Percuflex，HydroPlus 亲水涂层，环氧乙烷灭菌，一次性使用。 型号对应：
025‑0626：6Fr，26cm
025‑0726：7Fr，26cm
025‑0628：6Fr，28cm
1. 工作原理 Working Principle
中文 支架为两端猪尾卷曲结构，置入后近端卷曲固定于肾盂，远端卷曲固定于膀胱；支架管腔及侧壁侧孔建立人工引流通道，支撑开放受压 / 损伤 / 狭窄的输尿管，使肾盂尿液绕过梗阻部位，沿支架通道流入膀胱；人体体温下材质变软贴合输尿管管壁，双猪尾结构防止支架移位脱出，亲水涂层降低黏膜摩擦损伤风险。
English This stent adopts double‑pigtail design. After implantation, the proximal coil is anchored in renal pelvis and distal coil in urinary bladder. The inner lumen and lateral side holes establish an artificial drainage channel to prop open obstructed, injured or stenotic ureter, allowing urine from renal pelvis bypass obstruction and flow down to bladder. The material softens under body temperature to conｆorm to ureteral wall. Dual‑pigtail structure prevents stent migration. Hydrophilic coating reduces friction‑caused mucosal traumaBoston Sci...。
2. 产品功能 Function
中文
实现肾脏至膀胱尿液引流，解除输尿管梗阻；
对损伤、术后、狭窄输尿管起内部支撑作用，保障输尿管愈合；
辅助碎石术后结石碎屑、血凝块排出；
可经支架管腔注射造影剂完成上尿路造影（该系列支持注射）。
English
Drain urine from kidney to bladder and relieve ureteral obstruction;
Provide internal support for injured, postoperative or stenotic ureter to facilitate ureteral healing;
Facilitate passage of stone fragments and blood clots after lithotripsy;
Contrast medium can be injected through stent lumen for upper urinary tract imaging.
3. 产品特点 Product Features
中文
Percuflex 基材：室温下具备推送刚性，人体体温环境变软，兼顾植入推送性能与体内柔顺度；
HydroPlus 亲水涂层，遇水润滑，降低置入摩擦，减少输尿管黏膜损伤；
双猪尾防移位设计，两端卷曲锚定，降低支架上移、下移脱出风险；
薄壁大管腔设计，侧壁多组引流侧孔，保障引流通畅；
X 线下可显影，透视下可确认支架位置；
环氧乙烷灭菌，一次性无菌使用；
配套推送器械，内窥镜 / 透视下逆行放置操作便捷。
English
Percuflex material: rigid for delivery at room temperature, softens under body temperature, balancing push‑ability and in‑vivo compliance.
HydroPlus hydrophilic coating, lubricated when wet, reduces friction and ureteral mucosal injury during implantation.
Anti‑migration double‑pigtail anchoring design to prevent upward or downward displacement.
Thin‑wall & large inner‑lumen structure with multiple lateral drainage holes to guarantee efficient urine drainage.
Radiopaque under fluoroscopy for position verification.
EO sterilized, single‑use sterile device.
Delivered with matching accessories for retrograde placement under endoscopy and fluoroscopyBoston Sci....
4. 技术参数 Technical Specifications
表格
| 中文 | English |
|---|---|
| 型号：025‑0626 | Model:025‑0626 |
| 规格：6Fr，长度 26cm | Size:6Fr, Length 26cm |
| 型号：025‑0726 | Model:025‑0726 |
| 规格：7Fr，长度 26cm | Size:7Fr, Length 26cm |
| 型号：025‑0628 | Model:025‑0628 |
| 规格：6Fr，长度 28cm | Size:6Fr, Length 28cm |
| 主体材料：Percuflex 聚合物 | Material:Percuflex polymer |
| 涂层：HydroPlus 亲水性涂层 | Coating:HydroPlus hydrophilic coating |
| 灭菌方式：环氧乙烷（EO） | Sterilization:Ethylene Oxide(EO) |
| 使用方式：一次性使用 | Usage:Single‑use only |
| 最大留置时间：依据说明书，最长不超 12 个月 | Max indwelling time:Up to 12 months per IFU |
| 显影特性：X 射线不透射线，透视可视 | Radiopacity:Radiopaque under fluoroscopy |
| 适配导丝：0.038 英寸导丝 | Compatible guidewire:0.038 inch guidewire |
| 货架有效期：2 年 | Shelf life:2 years |
5. 使用方法 Method of Use
中文
术前确认型号规格完好，包装无破损，激活亲水涂层；
膀胱镜 / 输尿管镜置入，将导丝放置越过输尿管病变段抵达肾盂；
将支架沿导丝装载，使用推送器在 X 线透视监视下，逆行推送支架；
确认近端猪尾卷曲于肾盂内，远端猪尾卷曲位于膀胱腔内；
缓慢撤出导丝、推送器，透视复核支架两端卷曲形态与位置；
记录植入时间，标记计划取出时间；
到期通过膀胱镜完成支架取出；带牵拉缝线版本可按规范牵拉取出Boston Sci...。
English
Verify model and package integrity, activate hydrophilic coating before operation.
Under cystoscope/ureteroscope, advance guidewire past ureteral lesion into renal pelvis.
Load stent over guidewire. Retrogradely advance stent with pusher under fluoroscopic monitoring.
Confirm proximal pigtail coils within renal pelvis, distal pigtail resides inside bladder cavity.
Gently withdraw guidewire and pusher, re‑check stent position and coil configuration under fluoroscopy.
Document implantation date and scheduled removal date.
Remove stent via cystoscopy when indwelling period expires. Suture‑attached version can be retrieved by traction per protocolBoston Sci....
6. 适应症 Indications
中文
输尿管结石导致梗阻；体外冲击波碎石 ESWL 术前、术后输尿管引流；
输尿管镜、经皮肾镜等上尿路手术后引流支撑；
输尿管良性狭窄、肾盂输尿管连接部梗阻；
输尿管外伤、撕裂、术后吻合口支撑；
输尿管外压性梗阻（腹膜后纤维化、肿瘤压迫等）；
辅助结石碎片、血凝块排出；
内镜肾盂切开、取石术后引流；
术中可通过支架注射造影剂做上尿路显影评估。
English
Ureteral obstruction caused by ureteral calculi; pre‑ & post‑ESWL urinary drainage.
Drainage and support after ureteroscopy, percutaneous nephrolithotomy and other upper urinary tract procedures.
Benign ureteral stricture, ureteropelvic junction obstruction.
Ureteral trauma, laceration and postoperative anastomotic stoma support.
Extrinsic ureteral compression obstruction (retroperitoneal fibrosis, tumor compression etc.).
Facilitate elimination of stone fragments and blood clots.
Drainage after endopyelotomy and lithotomy.
Contrast medium can be injected through stent for upper urinary tract radiographic evaluation.
7. 禁忌症 Contraindications
中文
无法纠正的、严重的泌尿道感染未控制患者；
输尿管完全断裂缺损，解剖结构丧失，无法锚定支架；
对支架材料、涂层成分存在明确过敏；
不适合尿路侵入操作的危重患者；
本型号不推荐作为经皮顺行植入（产品设计为逆行内镜置入）Boston Sci...。
English
Uncontrolled severe urinary tract infection that cannot be corrected.
Complete ureteral disruption with anatomical defect where stent anchoring is impossible.
Confirmed allergy to stent material or coating components.
Critically‑ill patients unfit for urinary invasive intervention.
This model is not designed for primary antegrade percutaneous placement; retrograde endoscopic implantation is recommendedBoston Sci....
8. 注意事项 Precautions / Warnings
中文
本产品仅一次性使用，严禁重复使用；包装破损、过期禁止使用；
推送支架遇阻力，禁止暴力推进，排查梗阻原因；
支架留置必须严格遵循说明书最大留置周期，按时取出或更换；
留置期间定期影像学复查，评估引流、支架移位、结壳钙化情况；
支架会存在血尿、尿频尿急腰痛等支架相关刺激症状，提前告知患者；
避免支架扭曲弯折，防止支架断裂；
带取出缝线留置不可超过 14 天，避免缝线钙化包埋；
若出现发热、持续腰痛、严重血尿，及时临床处置；
必须由经过泌尿外科介入培训医师操作；
不可作为植入物使用Boston Sci...。
English
Single‑use only, re‑use prohibited. Do not use if package damaged or expired.
Never advance stent by force when resistance encountered; identify obstruction cause.
Strictly follow maximum indwelling period specified in IFU; remove or replace stent on schedule.
Periodic imaging follow‑up during indwelling to assess drainage, migration and encrustation.
Inｆorm patient of common stent‑related symptoms including hematuria, frequency, urgency and flank pain.
Avoid kinking or bending stent to prevent fracture.
Retrieval suture indwelling time shall not exceed 14 days to prevent suture encrustation.
Prompt clinical intervention for fever, persistent flank pain or severe hematuria.
Device shall only be operated by physicians trained in urological endourology.
Not intended for permanent implantationBoston Sci....
9. 存储条件 Storage Conditions
中文
存储于阴凉干燥环境，避免阳光直射，远离热源；
温度：5‑30℃，避免冷冻；
防潮，不可挤压、撞击包装；
在原包装内保存，使用前再拆封；
在有效期内使用。
English
Store in cool and dry place, keep away from direct sunlight and heat source.
Storage temperature:5‑30℃, do not freeze.
Keep moisture‑proof; avoid squeezing or impacting package.
Keep in original packaging until ready for use.
Use within shelf‑life period.
说明书核心摘要 Core IFU Summary
中文 该产品为 Ⅲ 类介入医疗器械，双猪尾输尿管支架，Percuflex 基材 + HydroPlus 亲水涂层，环氧乙烷灭菌，一次性使用；用于内窥镜或透视下实现肾脏至膀胱尿液引流，同时可经支架注射造影剂；包含支架、推送定位组件；仅逆行内镜置入，严禁暴力操作；必须按期取出，禁止留置；需定期影像随访；操作受训泌尿外科医师；一旦包装破损禁止使用。
English This is Class Ⅲ interventional medical device, double‑pigtail ureteral stent made of Percuflex with HydroPlus hydrophilic coating, EO sterilized for single‑use. It provides urine drainage from kidney to bladder under endoscopy or fluoroscopy, and allows contrast injection through stent lumen. Kit includes stent and delivery positioning accessories. Only for retrograde endoscopic placement; forceful manipulation is forbidden. Stent must be removed on schedule, permanent implantation is prohibited. Periodic radiographic follow‑up is required. Operation restricted to trained urologists. Discard if package integrity compromised.
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.
热门标签：厂商供应波科输尿管支架025‑0626025‑0726025‑0628,波科输尿管支架,输尿管支架025‑0626
