Product Specification
| Product Name | EBUS-TBNA Needle |
|---|
| Application | Guided Transbronchial Needle Aspiration |
| Materials | Stainless steel 304, 316L, Nitinol |
| Hardness | HV 200-250 |
| Tip | Back Cut Point |
| Inner Diameter (ID) | 0.86 mm |
| Outer Diameter (OD) | 1.06 mm |
| Gauge | 19G |
| Length | 115 mm |
| Tolerance | +/-0.01 mm |
| Manufacturing | Laser Etching, Grinding |
| Certification | ISO 9001:2015, ISO 13485 |
| Facilities | Grinding Machine, 5 Axis Laser Cutting Machine |
| Packing | PP bag or tailor-made packing on request |
Material Selection
The materials used in EBUS needles are selected to ensure they meet the stringent requirements of medical procedures, providing a combination of strength, flexibility, biocompatibility, and compatibility with imaging technologies. Medical-grade stainless steel (often 304 or 316L) and Nitinol (Nickel-Titanium Alloy) are the most commonly used materials. Stainless steel can be modified to enhance visibility under ultrasound, ensuring precise guidance during procedures.
Both stainless steel and Nitinol comply with strict medical device standards. Stainless steel meets ISO 13485 and ASTM F899 standards, while Nitinol adheres to ISO 13485 for medical devices. These standards ensure that the materials are safe, reliable, and suitable for medical applications.
In terms of hardness, stainless steel and Nitinol typically fall within the 200-250 HV range. This hardness ensures that the needles are strong enough for tissue penetration while maintaining the necessary flexibility and resilience for accurate sampling. This balance of properties is crucial for the effective performance of EBUS needles in clinical settings.
Grinding
EBUS needles are designed with a back-cut point to enhance their performance during biopsy procedures. This design includes a bevel that extends towards the back of the needle, creating a sharp cutting edge that facilitates tissue penetration and sample collection. The needle is hollow, allowing for the aspiration of tissue samples.
The back-cut point tip is typically formed through a precise grinding process. First, the needle is initially shaped to approximate its final dimensions and taper. Next, a grinding machine is used to carefully grind the bevels of the needle, including the back-cut point. This process involves precise control of the angle and depth of the grind to achieve a sharp, efficient cutting edge. Finally, the needle tip undergoes additional finishing processes to smooth any rough edges and ensure the sharpness and precision of the back-cut point.
Laser Etching and Laser Marking
For EBUS (Endobronchial Ultrasound) needles, echogenicity is crucial because it enhances the needle's visibility during ultrasound-guided procedures. Echogenicity refers to how well a material reflects ultrasound waves, making the needle visible on an ultrasound image. To achieve this, various methods are used, including surface texturing, echogenic coatings, and echogenic markers.
One effective method is laser etching or laser marking. In this process, a high-precision laser, such as a CO2 or fiber laser, is used to etch fine patterns or grooves onto the needle's surface. Laser etching removes material to create precise grooves or textures, while laser marking modifies the surface to provide high-contrast features. This technique allows for exact control over the depth and pattern of the grooves, which improves the needle's echogenicity.
At Manners, we use advanced 5-axis laser cutting machines to create intricate spiral patterns on EBUS needles. These machines offer high machining accuracy, with positioning and cutting tolerances typically in the range of ±0.01 mm to ±0.1 mm, ensuring precise and consistent results for enhanced needle visibility and performance.
Electropolishing
After laser processing, EBUS needles undergo electropolishing to enhance their surface quality.
Electropolishing is a metal finishing process that removes a thin layer from the surface of metal parts, which smooths out irregularities and creates a shiny, mirror-like finish. This process not only improves the appearance of the needles but also boosts their corrosion resistance and overall performance.
For EBUS needles, it’s essential to follow standards like ISO 13485, ASTM B912, and ASTM A967. These standards ensure that the electropolishing process meets the necessary quality, safety, and performance criteria, providing a consistent and reliable finish for medical applications.
Ultrasonic Cleaning
After electropolishing, EBUS needles are subjected to ultrasonic cleaning to ensure they are thoroughly cleaned.
Ultrasonic cleaning uses high-frequency sound waves, typically between 20 kHz and 40 kHz, to clean complex and delicate parts. The ultrasonic transducers in the cleaning machine generate sound waves that create rapid pressure changes in the cleaning solution.
These changes produce microscopic bubbles, known as cavitation bubbles, which collapse and generate powerful shock waves. These shock waves effectively remove dirt, grease, and other contaminants from the needle surfaces, reaching into small crevices and intricate details. This method ensures that the EBUS needles are thoroughly cleaned and ready for use.
