厂商直销麦瑞通可调弯房间隔穿刺鞘HST-085-00
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厂商直销麦瑞通可调弯房间隔穿刺鞘HST-085-00
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
HST-085-00，HST-085-10，HST-085-20
结构及组成/主要组成成分
该产品由导管鞘、扩张器、导丝组成。导管鞘由导管鞘管、中间位置触觉指示器、手柄、导管鞘座、止血阀、侧支、旋塞阀组成。产品经环氧乙烷灭菌，一次性使用，货架有效期3年。
适用范围/预期用途
该产品适用于经皮将各种心血管导管导入到所有心腔，包括经房间隔穿刺到左心房。
1 工作原理 Working Principle
中文本品为经皮血管入路的可调弯导引鞘系统，由编织增强鞘管、手柄调弯机构、扩张器、导丝组成。通过手柄旋钮驱动鞘管远端实现双向可控偏转；在导丝‑扩张器辅助下经股静脉送达右心房，配合房间隔穿刺完成跨隔建立通路；鞘管内部腔道为诊断 / 治疗心血管器械提供稳定工作通道；止血阀、侧支通路实现冲洗、抽吸与止血；鞘管远端铂显影标记在透视下确认位置，编织结构抗扭抗折，完成将器械导入各心腔（含左心房）的介入通路建立。
EnglishThis is a percutaneous steerable introducer sheath system, composed of braided reinforced sheath tube, handle deflection mechanism, dilator and guidewire. Distal bidirectional controlled deflection is achieved by rotating the handle knob. Assisted by guidewire‑dilator assembly, the system advances via femoral vein into right atrium, establishes transseptal access after transseptal puncture. The inner lumen provides stable working channel for diagnostic and therapeutic cardiovascular devices. Hemostasis valve and side port enable flushing, aspiration and hemostasis. Distal platinum radiopaque markers confirm position under fluoroscopy. Braided construction delivers torque transmission and kink‑resistance to deliver devices into all cardiac chambers including left atrium。
2 产品功能 Product Function
中文
经皮血管介入，建立从外周静脉至心脏各心腔的器械输送通路；
支持双向可调弯，鞘头角度可控，便于定位房间隔穿刺位点及引导器械进入左心房；
止血阀防止血液反流、减少空气进入；侧支旋塞用于冲洗、抽血、给药；
配合导丝、扩张器完成血管‑心房通路扩张，兼容各类电生理、心血管介入导管通过鞘腔开展操作。
English
Establish percutaneous vascular access for device delivery from peripheral vein to all cardiac chambers.
Bidirectional steerable distal tip for precise positioning of transseptal puncture site and guiding devices into left atrium.
Hemostasis valve prevents back‑bleeding and air embolism; side‑arm stopcock supports flushing, blood aspiration and drug administration.
Cooperate with guidewire and dilator to dilate vascular‑atrial pathway, accommodate various electrophysiology and cardiovascular interventional catheters through sheath lumen.
3 产品特点 Product Features
中文
180° 双向可调弯，手柄触觉中立位指示器，旋钮点击反馈提示鞘头中性位置，便于术者判断头端朝向；
编织加强鞘管，抗扭、抗打折，弯曲形态保持力好；
远端柔软伤头端，降低心房壁穿孔风险；铂显影标记，透视下清晰可视Merit Medi...；
扩张器‑鞘管平滑过渡，跨房间隔推进阻力低，减少组织损伤；
一体式止血阀，器械交换时减少回血、进气；带侧支三通旋塞；
鞘内壁润滑涂层，器械交换摩擦力小；8.5F 外径，小卷曲弯型 HST‑085‑00；
全套组件环氧乙烷灭菌，一次性无菌使用。
English
180° bidirectional steerable deflection; tactile neutral‑position indicator with click feedback for distal tip orientation judgement.
Braided reinforced shaft: excellent torque transmission and kink‑resistance, durable curve retention.
Soft atraumatic distal tip reduces risk of atrial perforation; ｅmbedded platinum radiopaque markers for clear fluoroscopic visualizationMerit Medi....
Seamless dilator‑to‑sheath transition, low advancing resistance across interatrial septum to minimize tissue trauma.
Integrated hemostasis valve to limit back‑bleeding and air ingress during device exchange; side‑arm 3‑way stopcock included.
Inner lubricious coating reduces friction during catheter exchange; 8.5Fr outer diameter, small curl configuration for HST‑085‑00.
Ethylene‑oxide sterilized, single‑use sterile device.
4 技术参数 Technical Specifications
表格
| 中文参数 | 英文 Parameter | HST‑085‑00 数值 Value |
|---|---|---|
| 鞘外径 | Sheath Outer Diameter | 8.5 Fr |
| 鞘内径 | Sheath Inner Lumen | 适配 0.035" 导丝及兼容 8.5F 鞘介入器械 |
| 有效工作长度 | Working Length | 98 cm |
| 最大调弯角度 | Max Deflection Angle | 双向 ±180° |
| 弯型配置 | Curve Profile | Small curl 小卷曲（16.4 mm） |
| 显影标记 | Radiopaque Marker | 远端铂标记 |
| 配套导丝规格 | Guidewire (kit included) | 0.035 inch |
| 灭菌方式 | Sterilization | 环氧乙烷 Ethylene oxide (EO) |
| 使用属性 | Usage | 一次性 Single‑use only |
| 货架有效期 | Shelf‑life | 3 years 3 年 |
| 组件 | Components | 导管鞘、扩张器、导丝 sheath, dilator, guidewire |
中文：产品由导管鞘（鞘管、触觉指示器、手柄、鞘座、止血阀、侧支、旋塞阀）、扩张器、导丝组成； English: Kit consists of steerable sheath (shaft, tactile indicator, handle, hub, hemostasis valve, side arm, stopcock), dilator and guidewire。
5 使用方法 Method of Use（核心操作要点）
中文
术前核查包装完整性、灭菌有效期；全部组件肝素盐水预冲洗排气；
股静脉穿刺，置入配套导丝，沿导丝送入扩张器‑鞘装配组件，推送至右心房；
撤出导丝，保留扩张器‑鞘；配合房间隔穿刺针完成房间隔穿刺；
通过手柄调弯旋钮，依据触觉指示器 + 透视，调节鞘管远端角度，定位穿刺位点；
确认跨隔成功后，推送鞘管进入左心房，撤出扩张器；锁紧 / 确认止血阀；
侧支通路持续肝素盐水冲洗，通过鞘腔送入电生理或其他心血管导管实施手术；
操作全程透视监测头端位置；手术完成后整体撤出整套鞘系统；本品一次性使用，严禁复用。
English
Inspect package integrity and expiry date prior to use; prime all components with heparinized saline to purge air.
Perｆorm femoral venous access; advance kit guidewire; deliver dilator‑sheath assembly over wire into right atrium.
Remove guidewire, keep dilator‑sheath in situ; perｆorm transseptal puncture with compatible transseptal needle.
Adjust distal tip deflection via handle knob; reference tactile indicator under fluoroscopy to position puncture site.
After successful septal crossing, advance sheath into left atrium then retract dilator; secure hemostasis valve.
Maintain continuous heparin‑saline flushing via side port; introduce electrophysiology or cardiovascular catheters through sheath lumen for procedure.
Monitor distal tip under fluoroscopy throughout intervention. Remove complete sheath system after procedure completion. Single‑use only; do not re‑process or reuse.
6 适应症 Indications
中文适用于经皮将各类心血管导管导入全部心腔，包括经房间隔穿刺通路进入左心房，用于心血管介入、电生理手术（如房颤消融等）建立介入通路。
EnglishIndicated for percutaneous introduction of various cardiovascular catheters into all cardiac chambers, including trans‑septal access into left atrium, to establish working access for cardiovascular and electrophysiological interventions (e.g. atrial fibrillation ablation).
7 禁忌症 Contraindications
中文（原厂同类 HeartSpan 系列公开禁忌要点）
左心房存在血栓、肿瘤；
严重的房间隔解剖畸形、既往房间隔补片 / 封堵器，无法安全实施房间隔穿刺；
无法耐受经静脉心内介入操作患者；
血管入路存在严重病变、闭塞，无法送入器械；
对器械材料成分过敏；
不具备房间隔穿刺手术指征的患者。
提示：完整禁忌症务必查阅原厂 IFU 纸质说明书。
English (HeartSpan series official contraindications)
Thrombus or tumor within left atrium.
Severe interatrial septum malｆormation, prior atrial septal patch / occluder where safe transseptal puncture cannot be perｆormed.
Patient intolerant to transvenous intracardiac intervention.
Severe disease or occlusion of intended vascular access preventing device delivery.
Known hypersensitivity to device materials.
Patients without clinical indication for transseptal procedure.
8 注意事项 Warnings & Precautions
中文
仅一次性使用，禁止复用、重复灭菌；复用会造成断裂、感染、颗粒脱落、严重并发症甚至死亡Merit Medi...；
受过心内介入、房间隔穿刺正规培训的心血管专科医师操作；
全程透视监控鞘管远端，避免暴力推送，防止心房、血管穿孔；
操作全过程严格肝素化，充分冲洗排尽系统内空气，预防空气栓塞与血栓；
调弯操作轻柔，不要在鞘受阻力时强行旋转调弯旋钮，防止鞘管扭折、损坏；
确认扩张器‑鞘锁合到位，跨隔操作避免组件分离；
止血阀交换器械时注意防止进气；侧支通路严禁高压注射；
包装破损、潮湿、超过有效期禁止使用；
术中警惕心包填塞、穿孔、血栓栓塞、血管损伤等介入相关并发症。
English
Single‑use only. Do not reuse, re‑sterilize or re‑process. Reuse may result in device fracture, cross‑infection, particle shedding, severe injury or deathMerit Medi....
Use only by cardiologists ｆormally trained in intracardiac intervention and transseptal puncture.
Keep distal tip under continuous fluoroscopic monitoring. Never advance with force to avoid atrial or vascular perforation.
Maintain adequate systemic heparinization throughout procedure; fully prime and purge air from entire system to prevent air‑embolism and thromboembolism.
Perｆorm deflection gently. Do not force the steering knob when sheath meets resistance, to avoid shaft kinking or damage.
Ensure dilator‑sheath locking is secured before crossing septum to prevent component disconnection.
Prevent air ingress during catheter exchange through hemostasis valve. Do NOT inject high‑pressure contrast via side‑arm port.
Do not use if package is damaged, damp or expired.
Be alert for procedure‑related complications: cardiac tamponade, perforation, thromboembolism, vascular injury.
9 存储条件 Storage Condition
中文存储于干燥、阴凉通风环境，避免阳光直射、高温、潮湿；远离射线源；不可重压挤压外包装；温度无特殊极端限定，常规医疗器械库房条件；货架有效期 3 年，包装完好条件下。
EnglishStore in cool, dry and well‑ventilated area. Avoid direct sunlight, high temperature, excessive humidity and radiation exposure. Do not crush outer package. Keep under standard medical device warehouse environment. Shelf‑life: 3 years with intact original package.
10 说明书核心摘要 IFU Core Summary
中文产品：可调弯房间隔穿刺鞘 HST‑085‑00（HeartSpan Steerable Sheath Introducer） 注册证：国械注进 20253030285 生产商：Merit Medical Systems, Inc. 美国麦瑞通；代理人：麦瑞通医疗器械（北京）有限公司 类别：Ⅲ 类介入耗材，EO 灭菌，一次性无菌，有效期 3 年。 用途：经皮建立通路，将心血管导管导入各心腔，支持房间隔穿刺进入左心房。 关键风险点：心房穿孔、心包填塞、空气栓塞、血栓栓塞、血管损伤；严禁复用；必须透视监护；充分肝素盐水预冲排气；调弯不可暴力操作。 操作前提：操作者必须具备房间隔穿刺操作资质；临床使用以原厂纸质 IFU 说明书为最终依据。
EnglishProduct: HeartSpan Steerable Sheath Introducer, Model HST‑085‑00 Registration No.: 国械注进 20253030285 Manufacturer: Merit Medical Systems, Inc. USA; Authorized Agent: Merit Medical (Beijing) Co., Ltd. Classification: Class Ⅲ interventional device, EO‑sterilized, single‑use sterile, shelf‑life 3 years. Intended use: Percutaneous access to deliver cardiovascular catheters to all cardiac chambers, support trans‑septal puncture for left‑atrium access. Key risks: Atrial perforation, cardiac tamponade, air‑embolism, thromboembolism, vascular trauma. Prohibit reuse. Continuous fluoroscopy required. Complete heparin‑saline priming & air‑purge. No force applied during steering deflection. Prerequisite: Operator must be qualified for transseptal puncture procedure. The original manufacturer printed IFU shall govern all clinical use.
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：厂商直销麦瑞通可调弯房间隔穿刺鞘HST-085-00,麦瑞通可调弯房间隔穿刺鞘,穿刺鞘HST-085-00
