厂商直供启灏可降解耳鼻止血绵8×2×1.5cm
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厂商直供启灏可降解耳鼻止血绵8×2×1.5cm
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 可降解耳鼻止血绵
管理类别 第三类
型号规格 10×2×1.5cm、8×2×1.5cm、6×2×1.5cm、4×2×1.5cm、2×2×1.5cm、9×3×1.5cm、7×3×1.5cm、5×3×1.5cm、3×3×1.5cm、4×4×0.6cm、5×5×0.6cm、5×7×0.6cm、5×9×0.6cm、6×2×0.6cm、6×4×0.6cm、6×6×0.6cm、8×4×0.6cm、8×6×0.6cm、10×10×0.6cm、6×2×0.15cm、4×2×0.15cm、2×2×0.15cm、2×φ1.0cm、2×φ1.5cm、4×φ1.0cm。
结构及组成/主要组成成分 产品为多聚醚型聚氨酯海绵，由（DL-丙交酯-co-ε-己内酯）-氨酯共聚物组成，本产品为一次性使用无菌产品，采用电子束辐照灭菌。
适用范围/预期用途 用于鼻腔、中耳与外耳术后的暂时压迫止血与支撑。
一、工作原理 Working Principle
中文产品由（DL - 丙交酯 - co-ε- 己内酯）- 氨酯共聚物构成多孔连通型多聚醚型聚氨酯海绵。填塞于耳鼻术腔后，接触血液、组织液快速亲水膨胀，自适应贴合不规则创面，形成均匀持续的机械压迫，压迫破损微血管实现止血；材料在体液环境下逐步发生水解降解，约 7 天液化崩解，降解产物可经自然腔道排出。多孔结构可吸收创面渗出液，维持术腔湿润微环境，减少创面粘连，同时对术腔起到物理支撑作用。EnglishThe product is a porous interconnected polyether polyurethane sponge composed of (DL-lactide-co-ε-caprolactone)-urethane copolymer. After placement in ENT surgical cavity, it absorbs blood and tissue fluid and hydrates rapidly, expanding to conｆorm to irregular wound surfaces and provide uniｆorm continuous mechanical compression to occlude damaged microvessels for hemostasis. The material undergoes gradual hydrolytic degradation in body fluid environment and liquefies within approximately 7 days; degradation residues are eliminated through natural cavities. The porous structure absorbs wound exudate, maintains moist microenvironment to reduce adhesion, and provides physical support for surgical cavity.
二、主要功能 Main Functions
中文
鼻腔、中耳、外耳术后术腔填塞，机械压迫实现暂时性止血；
对鼻窦、鼻腔术腔提供物理支撑，降低术后鼻腔粘连、狭窄风险；
吸收创面渗血与渗出液，维持创面湿润环境，促进黏膜修复；
材料可水解降解，无需二次手术取出，减少患者疼痛与二次出血；
适配不同术腔尺寸，多种规格满足鼻中隔、鼻窦、中耳、外耳道各类手术填塞需求。English
Cavity packing after nasal, middle ear and external ear surgery to achieve temporary hemostasis via mechanical compression;
Provide physical support for nasal and sinus cavities to reduce postoperative adhesion and stenosis risk;
Absorb blood and wound exudate, maintain moist wound environment and facilitate mucosal healing;
Hydrolytically degradable without secondary surgical removal, relieving pain and risk of rebleeding during extraction;
Multiple sizes available to match surgical needs for nasal septum, sinus, middle ear and external ear procedures.
三、产品特点 Product Features
中文
国产创新三类医疗器械，自主合成可降解聚氨酯高分子材料，进口替代产品；
连通多孔海绵结构，吸水后均匀柔性膨胀，不会产生局部高压造成黏膜缺血坏死；
术后约 7 天自然水解液化，降解过程不与创面粘连，降低二次出血；
无动物源性成分，生物相容性，过敏风险低；
规格型号丰富，长条薄板、圆柱多种形态，适配鼻腔、中耳、外耳道不同术区；
一次性无菌独立包装，电子束辐照灭菌，开箱即可术中使用；
质地柔韧易塑形，术中可根据术腔形态裁剪；
降解后呈糊状，可通过冲洗、自然引流排出，无需痛苦取出。English
Innovative domestic Class Ⅲ medical device with self-synthesized degradable polyurethane polymer, import-substituting product;
Interconnected porous sponge structure expands flexibly and evenly after hydration, avoiding focal high pressure and mucosal ischemia necrosis;
Natural hydrolytic liquefaction within ~7 days post-operation; no adhesion to wound surface during degradation to lower rebleeding risk;
Free of animal-derived components, excellent biocompatibility with low allergy risk;
Comprehensive specifications including strips, sheets and cylinders to fit nasal, middle ear and external ear cavities;
Single-use sterile individual pouch, E-beam radiation sterilized, ready for intraoperative use;
Flexible and malleable, can be trimmed intraoperatively to adapt cavity geometry;
Degrades into pasty residues removable via irrigation or natural drainage, eliminating painful manual extraction.
四、技术参数 Technical Specifications
中文
产品名称：可降解耳鼻止血绵
商品名：博恩绵 ®
注册证编号：国械注准 20253140731
主要原材料：(DL - 丙交酯 - co-ε- 己内酯)- 氨酯共聚物（多聚醚型聚氨酯）
灭菌方式：电子束辐照灭菌
使用形式：一次性使用，无菌
降解周期：体内环境约 7 天水解液化
规格尺寸（主流）：长条款：10×2×1.5cm、8×2×1.5cm、6×2×1.5cm、4×2×1.5cm；薄板款：4×4×0.6cm、5×5×0.6cm、5×7×0.6cm；圆柱款：Φ1.0cm、Φ1.5cm（中耳外耳道专用）
膨胀特性：接触生理盐水 / 血液后快速吸水膨胀
货架有效期：36 个月
管理类别：第三类医疗器械（14-08 可吸收外科止血材料）English
Product Name: Degradable ENT Hemostatic Sponge
Trade Name: BoenSponge®
Registration No.: National Medical Device Registration No. 20253140731
Raw Material: (DL-lactide-co-ε-caprolactone)-urethane copolymer (polyether polyurethane)
Sterilization Method: Electron beam radiation sterilization
Application: Single-use, sterile
Degradation Period: Hydrolytic liquefaction within approx. 7 days in vivo
Available Sizes (mainstream):Strips:10×2×1.5cm,8×2×1.5cm,6×2×1.5cm,4×2×1.5cm;Thin sheets:4×4×0.6cm,5×5×0.6cm,5×7×0.6cm;Cylinders: Φ1.0cm, Φ1.5cm (for middle/external ear)
Hydration Perｆormance: Rapid water absorption and expansion upon contact with saline or blood
Shelf Life: 36 months
Risk Class: Class Ⅲ Medical Device (14-08 Absorbable Surgical Hemostatic Material)
五、使用方法 Operation Procedure
中文
根据术腔大小、手术类型选取合适规格止血绵，打开无菌外包装；
可按需使用无菌生理盐水浸润，或直接干态置入术腔；可使用无菌剪刀修剪至适配尺寸；
将止血绵完整填入手术创面区域，确保海绵贴合术腔创面，实现均匀压迫；
术毕常规记录填塞起止时间；
术后遵医嘱使用鼻腔冲洗，促进降解残留物排出；
若存在特殊临床需求、需提前清理材料，可使用生理盐水充分润湿后内镜下轻柔清理。English
Select appropriate size sponge according to cavity dimension and surgery type, open sterile outer pouch;
May be pre-wetted with sterile normal saline or placed dry directly; trim to fit with sterile scissors if necessary;
Place sponge fully against surgical wound surface to ensure uniｆorm compression;
Document packing start and end time after operation;
Perｆorm nasal irrigation as prescribed postoperatively to facilitate discharge of degradation residues;
If early removal is clinically required, thoroughly hydrate sponge with saline and remove gently under endoscope.
六、适应症 / 适用范围 Indications / Scope of Application
中文用于鼻腔、中耳与外耳术后的暂时压迫止血与术腔支撑：
功能性内镜鼻窦手术、鼻中隔矫正术、鼻息肉切除术后鼻腔填塞止血与支撑；
中耳手术、乳突手术、外耳道手术术后术腔填塞止血；
鼻腔局部小范围出血创面临时填塞压迫止血。⚠️仅作为术后短期填塞材料，不可用于颅内、眼眶内组织填塞。EnglishFor temporary hemostasis via compression and cavity support after nasal, middle ear and external ear surgery:
Nasal packing and support after functional endoscopic sinus surgery, septoplasty, polypectomy;
Cavity packing after middle ear, mastoidectomy and external ear surgery;
Temporary packing for localized small nasal bleeding wounds.⚠️ Intended only for short-term postoperative packing; not for intracranial or intraorbital tissue placement.
七、禁忌症 Contraindications
中文
填塞区域存在活动性感染、化脓性炎症未控制者；
对产品高分子材料成分过敏患者；
脑脊液鼻漏、开放性颅底损伤（材料碎片存在颅内异位风险）；
严重凝血功能障碍、无法依靠局部压迫实现止血者；
气道严重畸形、填塞后存在窒息高风险患者；
无法完成术后随访、无法实施鼻腔冲洗的患者。English
Uncontrolled active infection or suppurative inflammation at target packing site;
Patients with known hypersensitivity to polymeric components of the product;
Cerebrospinal fluid rhinorrhea, open skull base injury (risk of intracranial migration of sponge fragments);
Severe coagulation disorders where local compression cannot achieve hemostasis;
Severe airway malｆormation with high risk of asphyxia after packing;
Patients unable to complete postoperative follow-up and nasal irrigation.
八、注意事项 Precautions & Warnings
中文
具备耳鼻喉手术资质的医师在手术室 / 内镜室无菌操作使用；
一次性使用，严禁重复使用、重复灭菌；
包装破损、渗漏、超过有效期禁止使用；
填塞时避免强力推送，防止海绵碎裂、碎片残留于术腔深部；
填塞后密切观察患者呼吸、有无剧烈头痛、耳闷加重、持续出血等不良反应；
指导患者术后避免用力擤鼻、剧烈咳嗽、头部剧烈晃动；
术后规范开展鼻腔冲洗，防止降解碎屑蓄积继发感染；
中耳使用时避免海绵接触鼓膜内侧腔隙；
若术后出现持续发热、疼痛加剧，及时内镜复查排除感染；
请勿浸泡抗生素溶液后使用，缺乏安全性验证。English
Only to be used aseptically by physicians qualified for ENT surgery in operating room or endoscopy suite;
Single-use only; reuse and re-sterilization are strictly prohibited;
Do not use if pouch damaged, leaking or expired;
Avoid forceful insertion during packing to prevent fragmentation and retained debris deep within cavity;
Monitor patient breathing, severe headache, worsening ear fullness and persistent bleeding after placement;
Advise patients against forceful nose blowing, violent coughing and rapid head movement postoperatively;
Standard nasal irrigation is recommended to prevent secondary infection caused by accumulated degradation debris;
Avoid placing sponge medial to tympanic membrane during middle ear application;
Perｆorm endoscopic examination promptly in case of persistent fever or aggravated pain to rule out infection;
Do not soak sponge in antibiotic solutions; safety data is not established.
九、存储条件 Storage Conditions
中文
环境温度：5 ℃ ~ +35 ℃；
相对湿度：30%～75%，无冷凝；
储存环境：干燥通风、避光、无腐蚀性气体；
远离热源、阳光直射，不可重压、穿刺外包装；
库存执行先出管理，定期核查有效期；
禁止存放于高温、潮湿密闭车厢。English
Ambient Temperature: 5 ℃ ~ +35 ℃;
Relative Humidity: 30%～75%, non-condensing;
Storage environment: dry, ventilated, protected from light and corrosive gas;
Keep away from heat source and direct sunlight; avoid heavy compression and puncture of outer packaging;
Adopt first-expired-first-out inventory management and regularly check expiry date;
Do not store inside sealed high-temperature humid vehicle compartments.
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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