Beschreibung
Der XISHAN Single-Use Vacuum-Assisted Breast Biopsy Probe Series (HJZ Series) is a precision-engineered rotary biopsy and excision needle portfolio dedicated to the DK-B-MS VABB system. Designed for high-definition ultrasound guidance, these sterile disposable probes enable high-accuracy diagnostic tissue sampling and complete conformal resection of benign breast lesions through a single 3–5 mm skin puncture.
Featuring a patented triple-blade rotary cutting architecture inside a slim single-tube profile, the HJZ probe delivers smooth, continuous tissue slicing and automated vacuum transport, producing intact, large-volume specimen cylinders with minimal puncture trauma and low procedural bleeding.
Key Structural & Clinical Advantages
Patented Triple-Blade Rotary Cutter
High-speed unidirectional rotary triple-edge cutter ensures sharp, continuous tissue slicing, eliminating tissue tearing, fragmentation, and crush artifacts.
Stepless Aperture Control (Up to 30 mm)
Sampling window length is steplessly adjustable in 1 mm increments (7G: 5–30 mm, 10G: 5–24 mm, 12G: 5–21 mm), allowing surgeons to match excision volume strictly to lesion boundaries.
Slim Single-Tube Profile
Innovative single-tube construction delivers a smaller outer puncture diameter compared to conventional double-tube designs, reducing incision size and scarring.
Continuous Automated Specimen Transport
Integrated internal fluidic vacuum channel continuously transfers harvested tissue cores directly to the collection chamber without needle withdrawal.
Probe Gauge Specifications & Clinical Selection
1. 7G High-Volume Probe (Therapeutic Excision & Large Lesions)
- Clinical Focus: Complete conformal excision of larger benign tumors (fibroadenomas ≥ 1.5 cm) and extensive hematoma/mastitis tissue debridement.
- Specimen Capacity: Maximum tissue volume per pass, drastically reducing total cutting cycles and operative duration.
- Aperture Range: Steplessly adjustable from 5 mm to 30 mm.
2. 10G Standard Probe (Versatile Diagnostic Biopsy & Resection)
- Clinical Focus: The multi-purpose clinical gold standard for diagnostic biopsy of suspicious calcifications/masses and excision of small-to-medium benign nodules.
- Balanced Performance: Ideal balance between high tissue yield and minimal puncture invasiveness.
- Aperture Range: Steplessly adjustable from 5 mm to 24 mm.
3. 12G Delicate Diagnostic Probe
- Clinical Focus: Precision diagnostic biopsy for small non-palpable lesions, dense glandular tissue, or nodules located near the nipple or chest wall.
- Minimal Trauma: Ultra-fine puncture tract (φ ~2.8 mm) for sensitive anatomical zones.
- Aperture Range: Steplessly adjustable from 5 mm to 21 mm.
Associated Sterile Consumables & Kits
- Transparent Specimen Collection Chamber: Clear collection box with built-in tissue filter basket for immediate visual confirmation and continuous specimen harvesting.
- Sterile Dual-Lumen Vacuum Tubing Set: Pre-connected, color-coded vacuum line ensuring instantaneous aspiration and waste fluid drainage.
- 1000 ml Waste Canister (ZKT Series): High-capacity reservoir with integrated hydrophobic bacterial filter and overflow prevention sensor.
Technical Specifications Matrix
| Probe Gauge | Outer Tube Profile | Sampling Window Range | Window Regulation | Guidance Modalities | Primary Clinical Use |
|---|---|---|---|---|---|
| 7G | Single Tube (φ ~4.8 mm) | 5 mm – 30 mm | 1 mm Stepless Step | Ultrasound Guidance | Large Benign Tumor Excision |
| 10G | Single Tube (φ ~3.5 mm) | 5 mm – 24 mm | 1 mm Stepless Step | Ultrasound Guidance | Standard Biopsy & Resection |
| 12G | Single Tube (φ ~2.8 mm) | 5 mm – 21 mm | 1 mm Stepless Step | Ultrasound Guidance | Fine Diagnostic Biopsy |
Packaging & Supply Standards
- Sterilization: 100% Ethylene Oxide (EO) sterilized, individually sealed in medical-grade double blister packaging with chemical indicator.
- Supply Format: 1 pc/box or 5 pcs/box, with individual UDI traceability barcodes.
- System Compatibility: Fully compatible with XISHAN DK-B-MS VABB control console and HJSB1 / HJSB2 motorized handpieces.
- Quality Standards: ISO 13485 certified medical device.
