Product Name | Meniscal Repair Needles |
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Application | All-inside Meniscal Repair Surgery |
Options | Straight, curved, reverse curved |
Materials | Stainless steel 304, Nitinol |
Hardness | HRC 22-25 |
Graduation | Calibrations |
Gauge | 16G, 17G |
Cannula Diameter | 1.45 mm |
Stylet Diameter | 0.88 mm |
Length | 177 mm |
Working Length | Around 150 mm |
Tolerance | +/-0.01mm |
Manufacturing | Grinding, Bending, Sliding Headstock Lathe, Laser Marking |
Certification | ISO 9001:2015, ISO 13485 |
Facilities | Grinding Machine, Bending Machine, Citizen Cincom R04 |
Packing | PP bag or tailor-made packing on request |
The Meniscal Repair Needle, also known as the delivery needle, is constructed from Stainless Steel 304 or Nitinol. It features needle tips available in curved, reverse curved, and straight options with bending angles of 0°, 12°, and 24°. The needle comprises two components: an external cannula and an internal stylet. The cannula has an outer diameter of 1.45 mm, an inner diameter of 1.1 mm, and a length of 177 mm. The stylet, made from solid steel, has a diameter of 0.88 mm and a length of 225 mm. The assembly involves inserting the stylet into the cannula, forming the complete structure of the Meniscal Repair Needle.
The external cannula appears as a single unit in shape, but it is composed of two tubular structures (referred to here as the outer tube and inner tube) that are laser-welded together. The inner tube is thinner and longer than the outer tube, with its top serving as the insertion part of the cannula of the meniscal repair needle.
The top and bottom of the outer tube both feature grooved sections. Typically, the grooves at the bottom are processed using Wire Electrical Discharge Machining (WEDM), while the cylindrical grooves at the top are machined using a lathe machine. However, Manners can utilize a Sliding Headstock Lathe, specifically the Japan Citizen Cincom R04, to simultaneously machine the grooves at both the top and bottom, achieving integrated forming and improving efficiency.
The insertion part of the cannula, known as the inner tube, plays a pivotal role in the Meniscal Repair Needle. Its sharpness, smoothness, and cleanliness significantly influence the success of meniscal repair surgery. Specifically, when processing the back-cut point needle through the Needle Grinding Machine, precise adjustments are crucial. Workers meticulously flush and sharpen the needle tip, making multiple angle adjustments to achieve the ultra-sharp presentation required for effective penetration of the meniscus during surgery.
Unlike conventional needle products, the insertion part of the meniscal repair needle features a 0.6 mm wide slot segment. Various methods exist for slotting in needle products, and Manners employs Wire Electrical Discharge Machining (WEDM) for this purpose. WEDM, also known as wire-EDM, is an improved modification of EDM. Once both the outer tube and inner tube are machined, they are laser-welded together, completing the fabrication of the cannula.
Similarly, Manners utilizes WEDM to cut grooves at both the front and rear ends of the solid stylet. The solid stylet features an extended 30mm groove at the front end and two symmetrical small grooves at the rear end. These front-end grooves are specifically designed to facilitate the stylet's movement through the curved needle tip, while the rear-end grooves serve to increase friction. Furthermore, surface sandblasting treatment is applied to enhance the friction of both the bottom of the cannula and the solid stylet, aiding in the injection molding of the handle.
Following machining and laser welding, the needle tip undergoes bending and laser marking. Laser marking serves to visualize the depth of needle penetration, while the curved design of the needle tip enhances accessibility to reach previously unreachable tears.
For bending the needle tip, a Bending Machine is typically employed. Manners Technology ensures that its curved meniscal delivery needle is optimally bent at the tip section, allowing surgeons to rotate the needle tip away from neurovascular structures during penetrating operations into the meniscus.
Following the bending process, the meniscus repair needle moves to the electropolishing stage where it undergoes a precise electrochemical treatment in accordance with ASTM B912 standards. This process is critical to improving corrosion resistance and eliminating surface imperfections such as burrs and microcracks. Electropolishing meticulously removes a microscopic layer of surface material, resulting in a smooth surface finish of 0.25 microns Ra.
Following electropolishing, the needle is ultrasonically cleaned to meticulously remove contaminants. Ultrasonic cleaners emit up to 40,000 sound pulses per second, with each pulse providing thorough cleaning when it contacts the needle surface. This high-frequency wave action ensures effective cleaning that surpasses conventional cleaning methods.
Finally, after the cleaning process, the Meniscal Repair Needle undergoes rigorous quality testing to validate its dimensional accuracy, structural integrity and compliance with specifications. This meticulous testing ensures that each Meniscus Repair Needle meets stringent standards for quality, durability and performance.