Micro-Needle Injector & Follicle Cartridge
Single-use sterile cartridge with 27G thin-wall implanter needle, plunger-driven follicle release, and pre-loaded 200-cell follicle reservoir.
The implanter needle is a 27G (OD 0.413 mm, ID 0.21 mm) thin-wall stainless steel hypodermic with a 12° back-bevel and electropolished tip (Ra < 0.2 µm). The needle is press-fit into a polycarbonate hub that mates to the voice-coil actuator with a kinematic 3-ball coupling repeatable to ±10 µm.
The cartridge is a single-use Class IIa device: a 200-cell follicle reservoir with individually addressed micro-wells (Ø 0.9 mm × 4 mm deep) on a rotary indexer driven by a stepper motor through a magnetic feedthrough so the sterile barrier is unbroken. Each well is pre-filled with 3.5 µL of preservation medium (Hypothermosol-FRS).
Cartridges are pre-sterilized by gamma irradiation at 25–40 kGy and shipped in a Tyvek peel pouch; the secondary tray is RFID-tagged with lot, expiry, and dosimetry confirmation that the control system verifies before unlock.
| Parameter | Value | Unit | Tolerance / Note |
|---|---|---|---|
| Needle gauge | 27 G | Thin-wall | |
| Needle OD | 0.413 | mm | |
| Needle ID | 0.21 | mm | |
| Bevel angle | 12 | ° | Back-bevel |
| Tip Ra | <0.2 | µm | Electropolished |
| Reservoir cells | 200 | Rotary indexer | |
| Well dimensions | Ø0.9 × 4 | mm | |
| Preservation medium | Hypothermosol-FRS | 3.5 µL / well | |
| Coupling repeatability | ±10 | µm | Kinematic 3-ball |
| Sterilization | Gamma 25–40 kGy | Per ISO 11137 | |
| Shelf life | 18 | months | RFID-verified expiry |
| Class | IIa | EU MDR |