Views: 36 Author: Site Editor Publish Time: 2025-07-24 Origin: Site
As a core instrument in minimally invasive surgical procedures, laparoscopic staplers must be produced in strict accordance with medical device production standards to ensure product precision, safety, and reliability. The following details the production process, key links, and quality control, along with core keyword phrases.
I. Material Selection and Pretreatment
The material selection of laparoscopic staplers directly affects product performance and safety, which must meet the requirements of biocompatibility, mechanical strength, and sterility.
Main Materials: Structural components such as handles and shells mostly use medical-grade ABS or PC plastics, which have the characteristics of impact resistance, easy processing, and strong chemical stability, and must pass the ISO 10993 biocompatibility test.
Core Component Materials: Staples are made of titanium alloy or stainless steel (such as 316L). Titanium alloy is lightweight and corrosion-resistant, suitable for long-term contact with human tissues; cutting blades are made of high-hardness medical stainless steel to ensure sharpness and wear resistance.
Pretreatment Process: Metal materials need to go through pickling and passivation to remove surface impurities, while plastic parts are deburred and ultrasonically cleaned after injection molding to ensure surface cleanliness. [Insert image: Material pretreatment workshop, showing metal part pickling tanks and plastic part cleaning equipment]
II. Processing and Precision Control of Core Components
1. Processing of Staples and Cartridges
Staples are formed in one go through precision stamping dies, with dimensional errors controlled within ±0.01mm to ensure consistent staple shape after firing (standard B-type or D-type).
Cartridges are milled and formed using CNC machining centers, with the spacing error of internal staple slots ≤0.02mm to ensure uniform force when staples are fired. [Insert image: Close-up of a CNC machining center processing a cartridge, showing precision tools and semi-finished cartridges]
2. Assembly of Transmission System
Transmission components such as gears and springs of manual laparoscopic staplers need precision grinding to ensure a transmission efficiency of ≥95% and the firing force fluctuation range within ±5N.
Motors and reducers of electric laparoscopic staplers are fixed by laser welding, with a transmission gap ≤0.005mm to avoid jamming during surgery.
III. Final Assembly and Functional Testing
1. Aseptic Environment Final Assembly
The final assembly workshop must meet Class 8 cleanroom standards, and operators wear sterile protective clothing. The assembly process includes:
Docking the cartridge with the firing component to ensure no misalignment of staple arrangement.
Installing the handle and transmission rod, and testing the opening and closing angle (electric models need to reach ±1° precision).
Sealing the shell and reserving a sterile packaging interface.
2. Functional and Safety Testing
Firing Test: Simulate surgical scenarios and fire 10 times to check the staple formation rate (100% qualified required) and the integrity of the cutting blade.
Leakage Test: Conduct IPX7 waterproof testing on the battery compartment of electric models to ensure no liquid penetrates into the internal circuit.
Biocompatibility Retest: Randomly select finished products for cytotoxicity testing to ensure no release of harmful substances.
IV. Sterile Packaging and Traceability System
EO (Ethylene Oxide) sterilization packaging is adopted, with the residual sterilization amount ≤10μg/g and the packaging seal strength ≥20N/15mm.
Each product is marked with a unique traceability code, recording information such as material batches, processing dates, and test results, which can be queried through scanning codes for the entire life cycle data.
