厂商直销日本北里单腔双腔取卵针16G17G18G19G20G21G
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厂商直销日本北里单腔双腔取卵针16G17G18G19G20G21G
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 取卵针Kitazato OPU Needle
管理类别 第二类
型号规格 见附页
结构及组成/主要组成成分 该产品由针管、针座、外圆椎接头、内圆椎接头、连接管、吸引用硅树脂栓塞、保护管、不锈钢管、加压连接管组成。
适用范围/预期用途 本产品在临床上用于超声下经阴道或腹腔镜下卵泡的收集。
大类区分：单腔型（单纯抽吸）、双腔型（抽吸 + 卵泡冲洗）；针体标准长度：32.5cm、35cm
编码规则说明：31 开头 = 无延长吸引管（注射器手动抽吸款）32 开头 = 带 80cm 吸引管路（泵吸 / 硅胶塞款）33 开头 = 双管路（吸引管 + 真空分管，负压泵专用）末尾 300=32.5cm；350=35cm
A、
一、单腔取卵针（Single Lumen）
1）无延长吸引管路｜鲁尔直头（手动注射器抽吸）
316001 ｜16G，32.5cm317001 ｜17G，32.5cm318001 ｜18G，32.5cm319001 ｜19G，32.5cm320001 ｜20G，32.5cm321001 ｜21G，32.5cm
2）带 80cm 吸引管路（硅胶塞，负压泵适用）
326350 ｜16G，35cm327350 ｜17G，35cm328350 ｜18G，35cm329350 ｜19G，35cm320350 ｜20G，35cm321350 ｜21G，35cm320300 ｜20G，32.5cm321300 ｜21G，32.5cm
3）双管路版本（80cm 吸引管 + 60cm 真空分管）
336350 ｜16G，35cm337350 ｜17G，35cm338350 ｜18G，35cm339350 ｜19G，35cm
二、双腔冲洗型取卵针（Dual Lumen，可卵泡冲洗）
376350 ｜16G，35cm377350 ｜17G，35cm378350 ｜18G，35cm
备注：北里注册证内双腔仅获批 16G/17G/18G（35cm），无 19G/20G 双腔型号。
三、临床选型简易参考
手动注射器取卵 → 316001 / 317001 / 318001 系列（无延长管）
负压吸引泵、常规 IVF 周期 → 327350（17G35cm）、328350（18G35cm），生殖中心主流常备
微刺激、自然周期、追求微创低痛感 → 329350（19G）、320350（20G）
需要卵泡冲洗，提升获卵率 → 377350（17G 双腔）、378350（18G 双腔）
B、
一、工作原理 Working Principle
中文在阴道超声实时影像引导下，取卵针沿超声探头穿刺引导架经阴道壁穿刺抵达卵巢卵泡。针管内腔连通负压吸引泵或负压注射器，依靠负压流体吸力将卵泡液连同卵母细胞一同抽吸至体外收集容器；双腔型号可通过独立冲洗通道向卵泡内注入卵泡冲洗液，实现卵泡冲洗，提升获卵率。针尖采用三斜面切削结构，顺畅穿透组织；尖端超声显影环便于术中实时定位，穿刺目标卵泡，减少卵巢组织机械损伤。
EnglishUnder real-time transvaginal ultrasound guidance, the oocyte retrieval needle passes through vaginal wall via ultrasound probe guide sheath and punctures into ovarian follicles. The needle lumen connects to vacuum aspiration pump or syringe. Negative pressure draws follicular fluid together with oocytes outwards into collection vessel.Dual-lumen version equips independent flushing channel to infuse follicle flushing medium for follicle lavage and improve oocyte recovery rate. Triple-cut tip enables smooth tissue penetration. Echogenic marker at tip allows real-time visualization under ultrasound for precise targeting and minimizing mechanical trauma to ovarian tissue.
二、产品功能 Functions
中文
超声引导下经阴道穿刺卵巢卵泡，建立负压抽吸通路，抽取卵泡液与卵母细胞；
双腔款具备独立冲洗通道，可对卵泡进行反复冲洗，收集隐匿于卵泡壁的卵母细胞；
尖端显影标记，便于超声下清晰识别针尖位置，定位目标卵泡；
薄壁针管设计，兼顾穿刺外径与充足内腔，保障卵泡液顺畅抽吸；
标准化鲁尔接口，兼容主流负压吸引泵、采集管路与冲洗注射器。
English
Puncture ovarian follicles transvaginally under ultrasound guidance, establish negative pressure channel to aspirate follicular fluid and oocytes;
Dual-lumen model owns separate flushing channel for repeated follicle lavage to retrieve oocytes adhered to follicle wall;
Distal echogenic marker enables clear visualization of needle tip for accurate follicle targeting;
Thin-wall shaft balances small outer puncture diameter and sufficient inner lumen for smooth fluid aspiration;
Standard Luer connector compatible with mainstream vacuum pumps, collection tubing and flushing syringes.
三、产品特点 Product Features
中文
薄壁不锈钢针管工艺：同等外径下更大内腔，降低抽吸流速阻力，减小卵子受剪切力损伤；
三斜面钝化切削针尖：穿刺顺滑、组织撕裂风险低，减轻术中出血与患者术后不适；
针尖近端一体式超声显影环：超声图像辨识度高，避免针尖盲区误操作；
分为单腔（单纯抽吸）、双腔（抽吸 + 冲洗）两大系列，适配不同临床方案；
针体内壁高精度抛光，降低卵母细胞黏附概率；产品通过小鼠胚胎毒性检测（MEA），无胚胎毒性；
多规格梯度选择：16G～21G，大 G 细针适合微刺激 / 自然周期，降低创伤；
人体工学带方位标识手柄，术中可判断针尖斜面朝向；
原装日本进口，EO 独立无菌包装，严格内毒素控制，满足生殖中心 IVF 质控标准。
English
Thin-wall stainless steel shaft: larger inner bore under identical outer diameter, reduce aspiration flow resistance and shear stress injury to oocytes;
Blunted triple-cut tip: smooth penetration, lower risk of tissue laceration, intraoperative hemorrhage and postoperative discomfort;
Integrated echogenic marker adjacent to tip, excellent visibility on ultrasound to prevent blind misoperation;
Two series available: single-lumen for aspiration only; dual-lumen for aspiration plus follicle flushing, matching various clinical protocols;
Highly polished inner surface reduces oocyte adhesion. Passes Mouse Embryo Assay (MEA), no embryotoxicity;
Complete gauge portfolio 16G～21G. Fine large-gauge needles are ideal for mild stimulation / natural cycle to minimize trauma;
Ergonomic hub with orientation indicator to recognize bevel direction during procedure;
Original imported from Japan, individually EO sterile packed, controlled low endotoxin level, fully compliant with IVF laboratory quality standard.
四、技术参数 Technical Specifications
| 中文 | English |
|---|---|
| 产品名称：取卵针（OPU 取卵针） | Product Name: Oocyte Retrieval Needle (OPU Needle) |
| 型号分类：单腔型 / 双腔冲洗型 | Type: Single Lumen / Dual Lumen (Flushing Type) |
| 常用规格：16G、17G、18G、19G、20G、21G | Available Gauge: 16G,17G,18G,19G,20G,21G |
| 标准有效长度：32.5cm / 35cm | Standard Working Length: 32.5cm / 35cm |
| 针体材质：医用奥氏体不锈钢 | Shaft Material: Medical grade austenitic stainless steel |
| 灭菌方式：环氧乙烷（EO） | Sterilization: Ethylene Oxide (EO) |
| 使用属性：一次性使用，严禁复用、二次灭菌 | Usage: Single-use only, reuse & resterilization prohibited |
| 质控标准：内毒素＜20EU / 支，通过胚胎毒性试验 | QC Standard: Endotoxin ＜20EU/unit, MEA negative |
| 适配设备：生殖中心负压吸引系统、卵泡冲洗注射器 | Compatible Equipment: IVF vacuum aspiration system, follicle flushing syringe |
| 货架有效期：3 年 | Shelf Life: 3 years |
五、使用方法 Operation Instructions
中文
术前核查外包装、无菌屏障、有效期，生殖中心洁净区域拆封；
根据方案选择单腔 / 双腔型号，连接负压管路（或冲洗注射器），使用预热卵泡冲洗液预冲整条针管，排尽管道空气；
将取卵针安装于阴道超声探头穿刺导向架，超声下确认针尖显影清晰；
规范实施麻醉后，超声实时监控引导针尖经阴道、盆腔穿刺进入目标卵泡；
开启预设负压，缓慢抽吸卵泡液；双腔型号可同步进行卵泡冲洗，多次抽吸收集卵母细胞；
同一卵巢多卵泡穿刺时，尽量维持针尖在卵巢包膜内移动，减少反复进出造成出血；
全部卵泡操作完成后缓慢撤出穿刺针，观察穿刺点有无活动性出血；
使用完毕按照锐器医疗废弃物规范封闭处置。
English
Verify package integrity, sterile barrier and expiry date; unpack in clean IVF operation area;
Select single/dual lumen model according to clinical protocol. Connect vacuum tubing or flushing syringe. Prime entire needle with pre-warmed follicle flushing medium to eliminate air;
Mount retrieval needle onto transvaginal ultrasound guide sheath, confirm clear echogenic marker under ultrasound;
After standardized anesthesia, advance needle tip through vaginal fornix and pelvic tissue into target follicle under continuous ultrasonic monitoring;
Activate calibrated vacuum pressure, aspirate follicular fluid gently. Dual-lumen needle allows sequential follicle lavage to maximize oocyte yield;
For multiple follicles on same ovary, keep needle tip inside ovarian capsule as much as possible to reduce repeated penetration and bleeding risk;
Slowly withdraw needle after all follicles are processed, inspect puncture site for active bleeding;
Dispose used needle as regulated sharp medical waste.
六、适应症 Indications
中文本产品适用于阴道超声引导下经阴道卵巢卵泡穿刺，抽吸卵泡液并获取卵母细胞，用于体外受精 - 胚胎移植（IVF-ET）等辅助生殖技术；也可在腹腔镜下用于卵巢卵泡穿刺操作。
EnglishThis device is indicated for transvaginal ovarian follicle puncture under transvaginal ultrasound guidance, to aspirate follicular fluid and retrieve oocytes for assisted reproductive technology including In Vitro Fertilization and Embryo Transfer (IVF-ET). It can also be applied for ovarian follicle puncture under laparoscopy.
七、禁忌症 Contraindications
中文
盆腔急性炎症、活动性盆腔炎、阴道感染未控制；
严重凝血功能障碍、活动性出血倾向，无法耐受穿刺创伤；
盆腔严重粘连、卵巢位置异常，超声下无法安全建立穿刺路径；
已知对不锈钢、硅胶、环氧乙烷残留物严重过敏；
患者存在严重内科疾病，麻醉与穿刺操作风险极高；
可疑或确诊卵巢恶性肿瘤。
English
Acute pelvic inflammatory disease, uncontrolled active vaginal infection;
Severe coagulopathy or active bleeding diathesis unable to tolerate puncture trauma;
Severe pelvic adhesion or malpositioned ovary without safe ultrasound-guided access route;
Known severe allergy to stainless steel, silicone or EO residuals;
Severe systemic disease carrying extremely high risk under anesthesia and puncture;
Suspected or confirmed ovarian malignancy.
八、注意事项 Precautions
中文
具备辅助生殖资质、经过取卵手术规范化培训医师操作；全程严格无菌操作；
包装破损、密封失效、超出有效期禁止使用；一次性使用，严禁重复穿刺、清洗复用；
术前调试负压压力，压力过高会造成卵母细胞机械损伤，压力过低影响抽吸效率；
穿刺全程依靠超声实时监测，禁止盲穿；留意针尖显影位置，防止误伤盆腔血管、肠道、膀胱；
禁止干穿刺，针尖抵达卵泡前避免负压持续开启；
术中密切监测患者生命体征，警惕盆腔内出血、脏器损伤等并发症；
禁止使用未经生殖实验室验证的冲洗液体；
针管严禁弯折、挤压，防止内腔变形堵塞；废弃针头必须投入锐器盒，防止针刺伤。
English
Operation limited to physicians certified for ART and ｆormally trained for oocyte retrieval; strict sterile technique required throughout procedure;
Do not use if package damaged, seal broken or expired. Single-use only; repeated puncture, cleaning and reuse are strictly forbidden;
Calibrate vacuum pressure before operation. Excessive vacuum leads to mechanical oocyte damage; insufficient pressure reduces aspiration efficiency;
Continuous real-time ultrasound monitoring is mandatory; blind puncture is prohibited. Track echogenic tip to avoid accidental injury to pelvic vessels, bowel and bladder;
Do not maintain vacuum before tip enters follicle; dry puncture should be avoided;
Closely monitor patient vital signs during surgery, watch for complications such as intra-pelvic hemorrhage and visceral injury;
Only use flushing medium validated by IVF laboratory;
Avoid bending or squeezing needle shaft to prevent lumen deｆormation and blockage; discard used sharp needle into puncture-resistant sharps container to prevent needlestick injury.
九、存储条件 Storage Conditions
中文储存环境温度：5℃～30℃；相对湿度：30%～75%，无凝露；环境要求：干燥通风、无尘；避免阳光直射、重压、撞击；远离腐蚀性气体、有机溶剂；产品保持原装密封包装，平放或直立存放；禁止冷冻、高温暴晒；在 3 年货架有效期内使用，超过有效期严禁使用。
EnglishStorage Temperature: 5℃～30℃;Relative Humidity: 30%～75%, no condensation;Requirements: Dry, ventilated and dust-free; avoid direct sunlight, heavy compression and impact; keep away from corrosive gas and organic solvents;Store horizontally or vertically in intact original sealed package. Freezing and high-temperature exposure are prohibited;Use within 3-year shelf life. Discard expired products.
Shanghai Kangshida Medical Devices Co., Ltd. is a professional company engaged in the sales of medical devices, focusing on the agency and distribution of renowned medical equipment brands from both domestic and international markets. Its core product range covers full-scenario medical devices for physical examination, diagnosis, emergency treatment, laboratory testing, ultrasound, medical analysis, life sciences, disinfection and sterilization, rehabilitation therapy, operating rooms, emergency rooms, consulting rooms and other fields. Relying on its strong product sales capacity, excellent commercial reputation and integrity-based operation philosophy, the company has won unanimous recognition and trust from medical institutions and partners.
The steady and rapid development of the company is attributed to its carefully selected high-quality product portfolio. It always takes customer needs as the core orientation and is committed to creating long-term value and practical benefits for customers. As an authorized and exclusive agent for many well-known domestic and international manufacturers, the company has established a complete supply system of medical devices with reliable quality, fully meeting the needs of clinical diagnosis and treatment.
The company always takes improving customer satisfaction as its core goal. To strictly adhere to product standards and exceed the expectations of customers and manufacturers, it regularly provides training on professional ethics and professional business skills, forging a highly competent, efficient and executive team covering business, technology and management. The team implements a 7×24-hour all-weather response mechanism to provide professional and high-quality after-sales service and technical support, efficiently solving various equipment operation and maintenance problems. At the same time, the company offers exclusive services including same-day delivery and free distribution, ｆorming a closed loop covering supply, distribution and after-sales service to fully ensure the stable supply and worry-free use of medical equipment for medical institutions.
Upholding integrity as the foundation of its business, the company selects high-quality medical devices and provides professional services for customers, helping to upgrade the quality of medical services and contributing to the high-quality development of China's medical industry.
Intellectual Property Infringement Complaint: Kangshida Medical does not manufacture medical products; all products are sourced from original manufacturers. We will promptly address any intellectual property infringement issues.The content published herein is for reference only.
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