Absorbable intraosseous fixing device with biological activity and plasticity and forming method

Abstract

The invention relates to the field of biological medical apparatus and instruments, and particularly relates to an absorbable intraosseous fixing device with biological activity and plasticity and a forming method. The absorbable intraosseous fixing device comprises a bone fracture plate and bone screws, wherein the bone fracture plate is provided with fixing holes and is made by a biologically absorbable high polymer material and biologically active ceramics or biologically active glass; the biologically absorbable high polymer material is 70-95% of the total weight of a composite material in parts by weight, and the biologically active ceramics or biologically active glass takes up 5-30% of the total weight of the composite material; the biologically absorbable high polymer material is selected from one or more of polylactic acid, polycaprolactone, polylactic acid-glycolic acid copolymer, polyglycolic acid, polyhydroxyalkanoate and polyhydroxybutyrate, and the molecular weight is 100,000 to 2,000,000. The absorbable intraosseous fixing device is good in biocompatibility, and can be degraded after the device is implanted in the body; meanwhile, aseptic inflammation caused in the course of material degradation can be reduced, and the pain of a patient can be alleviated; in addition, the personalized customization can be realized.

Description

technical field [0001] The invention relates to the field of biomedical devices, in particular to a bioactive and plastic absorbable bone internal fixation device and a molding method. Background technique [0002] Metal fracture internal fixation materials (stainless steel, cobalt-based alloys, titanium alloys, etc.) have achieved great success in the treatment of fractures. In terms of treatment, metal internal fixation is still the most widely used internal fixation material. The reasons are that it has high strength, mature technology, low cost, can be easily changed in shape to adapt to the outline of bone, and is easy to preserve. However, there are significant defects in rigid metal internal fixation: ①The mechanical compatibility between metal material and bone tissue is not good. This mismatch of mechanical properties will lead to uneven stress distribution, causing relative movement between the implant and the bone under load, which directly leads to loosening or...

AI Technical Summary

Problems solved by technology

However, there are significant defects in rigid metal internal fixation: ① The mechanical compatibility between metal materials and bone tissue is not good

This mismatch of mechanical properties will lead to uneven stress distribution, causing relative movement between the implant and the bone under load, which directly leads to loosening or dislocation of the implant; more importantly, due to the stress shielding effect, the bone Osteoporosis, bone resorption or bone atrophy, so secondary fractures are prone to occur; in addition, due to the lack of sufficient mechanical stress stimulation, callus cannot be formed at the fracture site, not only that, but the rigid fracture internal fixation also makes the initial bone healing process Delay

②Poor histocompatibility of metal internal fixation

[0004] However, it is currently clinically believed that the problems of absorbable bone internal fixation devices on the market are as follows: ①Because the current clinically used absorbable bone internal fixation devices are made of bioabsorbable polymer materials and other components, and bioabsorbable high The degradation of molecular materials in the body is acidic, and the rest of the complex substances cannot neutralize the acid produced during the degradation process, so the acidity generated by the material as a whole during the degradation process will cause the matrix to produce an inflammatory reaction against foreign matter, and According to statistics, the incidence of foreign body inflammatory reactions in clinical practice has reached 7% to 20%, and 8% of the patients need to undergo extensive surgical drainage.

②Because the bioabsorbable polymer materials currently used in clinical production of absorbable bone internal fixation devices are all single polymer materials, and their plastic deformation rate is less than 100, it is impossible to adjust the bone plate according to the size and shape of the patient's wound during surgery. Tailoring after appropriate plastic deformation for individual customization

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