Industrialized preparation method of carbon fiber reinforced PEEK oral implant

Abstract

The application discloses an industrialized preparation method of a carbon fiber reinforced PEEK oral implant, and the metal-free implant with an elastic modulus of 15-20 GPa is prepared through accurate proportioning, melting granulation, injection molding / mold pressing, five-axis CNC processing, plasma surface activation, multi-stage cleaning and EO sterilization. The process is stable and controllable, has high batch consistency and high yield, is suitable for large-scale industrialized production, and the prepared product has good biocompatibility, is mechanically matched with alveolar bone, has high bone combination efficiency, and can be directly used for three types of medical instrument registration and clinical promotion.

Description

Technical Field

[0001] This invention relates to the field of medical implant material processing technology, specifically to a method for preparing carbon fiber reinforced PEEK dental implants that can be industrially mass-produced and are compatible with Class III medical device registration. Background Technology

[0002] Existing PEEK implant preparation processes suffer from problems such as unreasonable formulation, low processing precision, poor surface activity, and insufficient batch consistency, making it difficult to simultaneously meet the requirements for mechanical properties, biocompatibility, mass production stability, and registration application. Summary of the Invention

[0003] This invention provides a complete industrial preparation method, which standardizes all parameters from raw material ratio, granulation, molding, precision processing to surface modification, cleaning and sterilization, to ensure stable product performance, traceability and registrability. Beneficial effects All process parameters are controllable, suitable for large-scale industrial production, with a yield of ≥95%; High dimensional accuracy, compatible with standard clinical accessories, and strong compatibility; The surface activation effect is stable, and the bone integration efficiency is high. The cleaning and sterilization process complies with GMP and can be directly used for medical device registration. Detailed Implementation

[0004] Weigh out 80 parts of PEEK resin and 20 parts of chopped carbon fiber by weight, and vacuum dry at 120℃ for 4 hours; melt-blend and granulate using a twin-screw extruder at 370℃; mold at 380℃ and 180℃; perform five-axis CNC machining with a tolerance of ±0.02mm; activate with 200W plasma for 10 minutes after alumina sandblasting; and then perform three-stage ultrasonic cleaning and EO sterilization packaging. Attached Figure Description

[0005] Figure 1 is a schematic diagram of the process flow of an industrial preparation method for carbon fiber reinforced PEEK dental implants according to the present invention.

Claims

1. A method for preparing a carbon fiber reinforced PEEK dental implant, characterized in that, Includes the following steps: S1 Raw material formulation and drying: By weight, 75-85 parts of medical-grade PEEK resin and 15-25 parts of surface-modified short-cut carbon fiber are vacuum dried at 120℃ for 4 hours; S2 Melt blending and granulation: Twin-screw extruder temperature 360-400℃, screw speed 200-350rpm, melt blending, stretching, cooling, and pelletizing; S3 Molding: Injection molding or compression molding to obtain implant blanks; S4 Five-axis CNC precision machining: Machining external threads, internal connecting cavities, and anti-rotation structures, with a dimensional tolerance of ±0.02mm; S5 Surface modification: Medical-grade alumina sandblasting + oxygen / argon plasma activation, power 100-300W, treatment for 5-20 minutes; S6 Cleaning and sterilization: Three-stage ultrasonic cleaning + purified water rinsing + drying + EO sterilization + aseptic packaging.

2. The method according to claim 1, characterized in that, Short-cut carbon fiber length is 0.1–0.2 mm.

3. The method according to claim 1, characterized in that, Injection temperature 370~395℃, mold temperature 180℃.

4. The method according to claim 1, characterized in that, The surface roughness Ra after sandblasting is 1.2~2.0μm.

5. The method according to claim 1, characterized in that, The elastic modulus of the prepared implants was 15–20 GPa.

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