Product Specification

Material Selection

Vacuum-Assisted Breast Biopsy Needles are manufactured from high quality 316 stainless steel (SS316), known for its biocompatibility, durability and corrosion resistance. The hardness of SS316 is typically between 70-90 HRB, making it suitable for medical applications.

To ensure compliance with regulatory standards, all materials used in the production of these needles meet the requirements of the RoHS Directive 2011/65/EU, including the 2015/863 amendments. Manners provides Certificates of Compliance and confirms that all components, materials, and processes adhere to these regulations. Additionally, the manufacturing process follows rigorous quality management systems, including ISO 13485 and ISO 9001, ensuring high standards of quality and safety in the production of medical devices.

Custom Design

The Vacuum-Assisted Breast Biopsy Needle is a hollow, bore device designed for tissue sample extraction. Inserted through a small incision in the breast, it features an integrated vacuum system that creates negative pressure to draw and secure tissue samples. Inside the needle, a chamber temporarily stores the collected samples before they are analyzed. The cutting mechanism, which may include a rotating or reciprocating blade, slices off small pieces of tissue and transfers them into the chamber. The needle is also compatible with various imaging systems, ensuring precise placement and accurate targeting of the biopsy site.

Manners can manufacture three components of the Vacuum-Assisted Breast Biopsy Needle: the Needle Tip, Sample Notch Cannula, and Cutting Cannula. Different designs of Vacuum-Assisted Breast Biopsy Needles may have varying structures, and Manners supports customized needle services to meet specific design requirements.

Process Flow

Sliding Headstock Lathe

The manufacturing of the Vacuum-Assisted Breast Biopsy Needle involves precise machining of three key components: the Needle Tip, Sample Notch Cannula, and Cutting Cannula. Each part is crafted using the Citizen L12-1M7 Sliding Headstock Lathe, a machine renowned for its exceptional precision, with a positioning accuracy of ±0.005 mm and repeatability of ±0.002 mm.

This lathe performs various tasks, including milling the Needle Tip, slotting the Sample Notch Cannula, and flaring, end machining, inner chamfering, marking, and slotting the Cutting Cannula. The Needle Tip, the most challenging part to machine, requires about 30 minutes of milling. Its three curved faces are meticulously shaped to create a razor-sharp edge. The process involves cutting bevels with a ∅0.4531 inch flat end mill normal to the cut path, ensuring the precision and sharpness essential for the needle's function.

Laser Marking 

The Sample Notch Cannula of the Vacuum-Assisted Breast Biopsy Needle is marked using advanced laser marking technology. This process involves a focused laser beam that creates high-precision, permanent marks on the material's surface.

Laser marking is highly effective for producing detailed text, logos, barcodes, serial numbers, and patterns on various materials such as metals, plastics, ceramics, and glass. It utilizes high-energy-density lasers to vaporize surface material or induce color-changing chemical reactions, ensuring that the markings are durable and resistant to wear, fading, and environmental conditions. Unlike traditional marking methods that involve physical contact, laser marking is a non-contact process, which reduces the risk of damage or distortion, making it particularly suitable for delicate components like the Sample Notch Cannula.

Passivation

The Vacuum-Assisted Breast Biopsy Needle requires passivation to ensure its durability and performance in medical applications. Passivation is a chemical treatment process designed to enhance the corrosion resistance of metal surfaces, particularly stainless steel.

For the Needle Tip, Sample Notch Cannula, and Cutting Cannula, passivation typically involves immersing the components in a citric acid solution. This treatment effectively removes free iron and other contaminants from the surface, promoting the formation of a thin, protective oxide layer. This oxide layer significantly enhances the needle’s resistance to oxidation and corrosion, ensuring the components remain safe, effective, and compliant with medical standards throughout their use.

Electrolytic Polishing 

Electrolytic polishing and ultrasonic cleaning are crucial processes in the preparation of the Vacuum-Assisted Breast Biopsy Needle. This process involves immersing components such as the Needle Tip, Sample Notch Cannula, and Cutting Cannula in an electrolytic bath with a suitable electrolyte solution. When an electric current is passed through the bath, electrochemical reactions occur, smoothing and polishing the needle’s surface.

This treatment effectively removes surface imperfections like burrs and roughness, resulting in a highly polished, smooth finish. It also reduces friction, minimizes the risk of tissue damage during procedures, and enhances the needle’s resistance to corrosion and fouling.

Ultrasonic Cleaning

Following electrolytic polishing, ultrasonic cleaning is employed to ensure the needle is thoroughly free from contaminants and debris. In this process, the needle components are immersed in a cleaning solution and subjected to high-frequency ultrasonic waves. These waves generate microscopic bubbles that implode against the needle surfaces, dislodging and removing particles, dirt, and residues from hard-to-reach areas.

This meticulous cleaning not only ensures that the needle is clean but also maintains high standards of sterility and cleanliness essential for medical use. Ultrasonic cleaning is particularly effective for delicate components, as it avoids physical abrasion while achieving a high level of cleanliness necessary for clinical applications. Together, these processes ensure that the Vacuum-Assisted Breast Biopsy Needle is both safe and effective for use in medical settings.

If your item has a manufacturing defect in its materials or workmanship, you can return it at any time. We are here to help, please call us for any returns or questions at +86-755-23699351.