Biodegradable stent composite material and preparation method thereof

Abstract

The invention relates to a biodegradable stent composite material and a preparation method thereof. The degradable material has a multi-gradient composite structure, and comprises a matrix made of a medical metal or an alloy thereof, a chemical coupling layer attached to the surface of the matrix, a high polymer transition layer attached to the surface of the chemical coupling layer and a degradable high polymer functional layer fixed on the surface of the high polymer transition layer. The stent composite material has high mechanical property, degradation property and biocompatibility, also can absorb and carry needed therapeutic medicaments, and meets the requirement on clinical treatment. The degradable composite material can be used as stent materials of esophagi, biliary ducts, intestinal tracts, urethrae, tracheae and other non-vessel lumens and blood vessels, and also can be used for manufacturing artificial bones, bone nails, bone connectors, bone sutures, anchors for suture, intervertebral discs, hemostatic clamps, hemostatic forceps, hemostatic plates, hemostatic screws, tissue adhesives, sealants and other medical devices and products.

Description

technical field [0001] The invention belongs to the field of medical functional materials, and relates to a biodegradable scaffold composite material and a preparation method thereof. Background technique [0002] For benign / malignant strictures and obstructions of the esophagus, bile duct, intestinal tract, urethra, trachea, etc., traditional drug therapy and surgical operations have limited effects, and stent implantation has developed into an effective minimally invasive treatment technology in recent years. It is a fast, safe, but as a "permanent stent" that remains in the body, it is also a very effective and relatively safe medical method, which opens up a new treatment approach for diseases that are incurable or refractory by traditional surgery, and improves the health of cancer patients. Lifespan and chance of cure. At present, the stents widely used in clinical medicine are mainly Ni / Ti alloy stents, stainless steel stents, plastic stents, etc. These stents have ...

AI Technical Summary

Problems solved by technology

[0004] There are still many deficiencies in the clinical application of polymer degradable stents. The main problems exposed are: (1) Insufficient mechanical support strength, which is inferior to metal stents in restricting lumen retraction. At present, it is mainly used in cardiovascular stents. However, non-vascular lumens such as esophagus, bile duct, intestinal tract, urethra, and trachea usually require greater radial support, and pure polymer materials are difficult to meet the requirements; Thermal degradation occurs. With the degradation of polymer materials in the body, the mechanical properties of the stent are significantly reduced, which cannot meet the support requirements, resulting in displacement and slippage accidents; (3) The local heat generation of the polymer during the degradation process in the body, Accumulation of acidic degradation products, leading to issues such as tissue inflammation

[0008] (1) The chemical properties are too active in the electrolyte environment, the corrosion resistance is poor, and the degradation rate is too fast, so it must be used by proper surface treatment;

[0009] (2) There are no organic functional groups on the surface of metal materials, so it is difficult to absorb and load therapeutic drugs, so it is necessary to introduce an organic polymer functional layer on the surface

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