Технические характеристики
| Параметр | Значение / Описание |
|---|---|
| Название продукта | Specially Shaped Needle (Customized Cannula) |
| Диапазон манометров | 14G – 34G (customizable) |
| Наружный диаметр (OD) | 2.1 mm – 0.18 mm (depending on gauge) |
| Варианты длины иглы | 4 mm – 150 mm (customizable) |
| Needle Geometry | Straight, curved, angled, J-shaped, hooked, irregular (designed per requirements) |
| Материал канюли | Medical-grade stainless steel SUS304 / SUS316L (ISO 9626 compliant) |
| Отделка поверхности | Electropolished, siliconized, or Teflon-coated (optional, depending on application) |
| Материал ступицы | Medical-grade polypropylene, stainless steel, or custom design |
| Тип соединения | Luer-lock, Luer-slip, or proprietary |
| Sterilization Options | EO (Ethylene Oxide), Gamma irradiation, or non-sterile (for R&D/lab use) |
| Упаковка | Individual blister packs or bulk packaging, depending on order |
| Single-Use / Reusable | Typically single-use, but reusable options available upon request |
| Сертификация | ISO 13485, CE marking, FDA (depending on region and application) |
Specially Shaped Needle: Precision-Engineered Solutions for Complex Medical Challenges
Specially Shaped Needle Innovation Purpose
We pioneer the design and manufacture of non-standard needle geometries to overcome limitations in minimally invasive procedures. Our custom-engineered solutions enable breakthroughs in accessing confined anatomies, delivering novel therapies, and optimizing device-tissue interactions, transforming conceptual medical innovations into clinical reality.
Customization Advantages
Geometry Mastery
Parametric tip designs: J-hooks, helical coils, side-ports, multi-lumen profiles, or patient-specific curves.
Micro-scale features: Barbed retention elements, fluidic channels (≥50μm ID), or directional drug-elution windows.
Advanced Fabrication
Laser micromachining ±5μm tolerances.
Electroforming for seamless tapered transitions.
Shape-memory alloy integration (Nitinol).
Rapid Prototyping
3D-printed surgical-grade steel/PEEK prototypes in ≤72 hours.
In silico fluid dynamics/structural simulation reports.
| Material | Приложения |
|---|---|
| SUS316LVM | High-stress interventions (orthopedic/bone access) |
| Nitinol | Steerable neurovascular/electrophysiology tools |
| PEEK | MRI-guided biopsy systems |
| Gold-plated | Electroporation/ablation electrodes |
Clinical Transformation Examples
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Ophthalmic Microneedles: 35G kinked-tip design for subretinal drug delivery.
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Neurological Ports: Curved cannulas bypassing critical brain structures.
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Brachytherapy Seeds: Barbed deployment needles securing radioactive implants.
End-to-End Development Support
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Фаза 1: CAD/FEA моделирование → Фаза 2: Наборы для валидации животных → Фаза 3: Производство по стандарту ISO 13485
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Дорожная карта для регуляторов: Разработка досье для представления в FDA 510(k)/CE MDR
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Масштабируемость: От пилотных партий (50 единиц) до массового производства (1М+/месяц)
