All-degradable biological material and preparation method thereof

Abstract

The invention discloses an all-degradable biological material and a preparation method thereof. The preparation method of the all-degradable biological material comprises the following steps: 1) smelting and forming; 2) shot blasting; and 3) coating. The material disclosed by the invention comprises a pure magnesium or magnesium alloy base and a functional film covered on the base surface with degradation protection and self-degradation characteristics; and the integral material has the characteristic of controllable all-degradable absorption, and satisfies the serious requirements for ideal characteristics of degradable biological materials. The invention provides a preferred scheme for solving the contradiction between biodegradable characteristic utilization and degradation rate control of the absorbable biological material, especially medical magnesium alloy; and the related material and technique are not only suitable for common medical appliance products, but also have competitive edges in manufacturing of high-end medical appliance products, such as implantation instruments, especially secondary-operation-free implantation substances.

Description

technical field [0001] The invention belongs to the technical field of manufacturing and application of biomedical new materials and medical device products, and in particular relates to a fully degradable biomaterial and a preparation method thereof. Background technique [0002] With the development of social economy and the improvement of living standards, human beings are paying unprecedented attention to their own medical and health undertakings. The increasing pressure of survival, the accelerated pace of life, the intensification of environmental pollution, the frequent occurrence of food, transportation and production safety accidents, local wars, and natural disasters have caused diseases and traumas to become the ever-lingering haze of human beings. As an important means of modern medicine—an important basis and component of medical devices, biomaterials are used for the diagnosis and treatment of diseases, the repair, replacement or function enhancement of tissues...

AI Technical Summary

Problems solved by technology

However, the common problems of existing medical metal materials such as stainless steel, cobalt-chromium alloy, nickel alloy and titanium alloy are: in addition to being expensive, the mechanical compatibility, biocompatibility and biodegradability are not satisfactory

Taking titanium alloy, which has been widely used in clinical medicine, as an example, its main performance defects include: (1) Due to the mismatch of elastic modulus, the load transfer from the implant to the adjacent bone tissue is hindered, that is, "stress "shielding" effect, making it unavoidable as an implant (such as inhibiting bone healing, leading to osteoporosis, bone resorption or bone atrophy, or even secondary fractures, etc.); (2) The degradation of pure titanium in the body will lead to Allergies and even death, both Al and V in the typical titanium alloy Ti6Al4V are cytotoxic, among which V can cause chronic inflammation, and the combination of Al and inorganic phosphorus can lead to phosphorus deficiency and induce Alzheimer's disease at the same time; (3) due to poor biodegradability , after the damaged tissue / organ completes the functional reconstruction, the implant must be taken out by a second operation, thus blocking the patient's recovery process and adding additional physical and mental pain and economic burden

Although the above-mentioned technologies and the composite materials produced have their own advantages, they also have serious defects: or focus on the inhibition of matrix biodegradability and the improvement of biocompatibility, not only do not consider the surface modification layer in damaged tissue / After the completion of the functional reconstruction of the organ, the issue of biodegradation is "retire after success". On the contrary, in order to improve the modification effect, efforts have been made to synthesize / apply a dense and non-degradable modification layer according to the conventional thinking; or although taking into account the The biodegradability of the modified layer, but the comprehensive service performance is not ideal

In other words, when it is used as a "secondary operation-free" implant device or tubular / luminal tissue / organ scaffold material such as vascular stent, even in the service environment, the matrix can be gradually degraded and absorbed as expected, and the non-degradable shell ( The long-term existence of surface-modified membranes such as MAO membranes) or its peeled off fragments will also make all efforts to avoid permanent foreign body reactions in the body useless, and even bring catastrophic consequences (such as blockage of blood vessels)

As far as the latter is concerned, taking the preparation of composite materials by coating degradable polymer materials on the surface of the substrate as an example, there are the following main problems: (1) The potential hazards of acidic degradation products of polymer materials are not considered, such as a. The acidification of the local physiological environment then triggers aseptic inflammation, b. Accelerates the degradation of the magnesium alloy matrix, so no specific countermeasures / prevention measures have been proposed; (2) Polymer materials are used in isolation or only in combination with non-degradable HA ( Hydroxyapatite) used in combination, which limits its modification effect and application range; (3) Coating / substrate bonding force is not ideal, etc.

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