Description

The TEMNO Biopsy Needles by CAREFUSION are expertly crafted for precise core tissue biopsy procedures in various soft tissues, including the breast, kidney, liver, lung, prostate, thyroid, spleen, and lymph nodes. These single-use, sterile devices are not intended for bone biopsies, ensuring specialized application in soft tissue sampling.

Models and Specifications

The product line includes several models such as Temno Evolution, Adjustable Coaxial Temno (ACT), Original Temno, and Temno Elite. Each model offers distinct features, including:

• Sample Notch Sizes: Options of 10 mm or 20 mm, with ACT providing adjustable sizes from 9 mm to 19 mm.
• Needle Gauge Sizes: Available in 12G, 14G, 16G, 18G, 20G, and 22G.
• Needle Lengths: Ranging from 6 cm to 20 cm.

Design Features

The needles feature a sharp bevel tip or a four-bevel tip, enhancing penetration efficiency. Echogenic markings on the cannula and stylet improve ultrasound visibility, while centimeter depth markings ensure accurate placement under imaging guidance.

Ergonomics and Operation

The ergonomic design includes a compact, lightweight body with tactile-enhanced plunger and soft finger grips for one-handed operation. The firing mechanism allows smooth charging and advancement of the stylet, with a fire-ready indicator on select models.

Coaxial Introducer Needle

Compatibility with coaxial introducer needles allows multiple samples from a single puncture. The introducer needle includes features such as a positive-locking skin stop, trocar-point stylet, and echogenic tip, typically one gauge size larger than the biopsy needle.

Imaging and Accessories

Compatible with ultrasound and CT imaging, the TEMNO Biopsy Needles offer selectable penetration depths of 10 mm or 20 mm. Optional accessories include valved or standard coaxial introducer needles and Sample Assist™ for sample retrieval on select models.

Packaging and Sterilization

Each needle is sterilized using ethylene oxide and packaged in a single sterile barrier system. They are supplied in boxes containing 5 or 10 devices per case, depending on the model.

Usage Guidelines

Designed for use by trained physicians under imaging guidance, these needles are intended for single patient use only. They should not be reused or resterilized, and must be inspected for damage prior to use. Contraindications include use in patients with bleeding disorders or those on anticoagulant therapy, with potential complications such as hematoma, hemorrhage, and infection.

Procedure Overview

The procedure involves arming the device by retracting the plunger, setting the penetration depth, and inserting the needle under imaging guidance. The stylet is advanced to expose the sample notch, and the cutting cannula is fired to capture the specimen, with optional Sample Assist™ for removal.

These comprehensive features make TEMNO Biopsy Needles a reliable choice for precise and effective soft tissue biopsy procedures.