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Degradable magnesium alloy bio-implantation material and preparation method thereof

An implant material, magnesium alloy technology, applied in the field of biodegradable magnesium alloy bio-implant materials and its preparation, can solve the problems of "stress shielding, material mutation failure, non-degradable, etc., to improve corrosion resistance, improve comprehensive performance, Effect of reducing hot tear defects

Active Publication Date: 2015-04-08
CHINA WEAPON SCI ACADEMY NINGBO BRANCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, the implant materials mainly used clinically include stainless steel, titanium and titanium alloy, Co-Cr alloy, etc., but the clinical application of these materials has the following problems: (1) release of toxic metal ions or particles due to corrosion cause inflammation; (2) the elastic modulus of metal materials is much higher than that of human bone, which has a great "stress shielding" effect on local bone tissue, which may lead to the possibility of natural bone function degradation or even atrophy; (3 ) materials such as stainless steel, titanium and titanium alloys are biologically inert materials, which cannot be degraded in the body. When used as temporary implant materials such as vascular stents, bone nails, bone plates, and bone needles, secondary operations are required to remove them, which increases the Patient suffering, psychological and financial burden
There are risks in the direct use of conventional commercial magnesium alloys as biological materials, mainly because commercial magnesium alloys are used as structural materials, and issues such as biocompatibility of materials are not considered during design. For example, Al elements contained in AZ series alloys do not belong to An essential trace element for the human body, which is considered to be neurotoxic and is a factor leading to Alzheimer's disease. Moderate rejection of Al-containing magnesium alloys has been observed in in vivo tests
Based on domestic and foreign research results, although individual magnesium alloy materials have begun to be clinically applied to special parts of the human body, generally speaking, the degradable magnesium alloys that have been developed still have the following problems: (1) The corrosion rate of magnesium alloys is too fast, and it is easy to The degradation begins before the endothelialization process of the implant material is stable, so the expected degradation rate cannot be achieved; (2) The magnesium alloy implant material has the problem of environmentally assisted cracking (EAC), also known as stress corrosion cracking (SCC) or corrosion fatigue ( The EAC of CF) will lead to sudden failure of the material; (3) Compared with stainless steel and other materials, magnesium alloys are more brittle and have poor plastic deformation ability

Method used

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Examples

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Effect test

Embodiment 1

[0032] Alloy raw materials are configured according to the mass percentage composition of each component in the magnesium alloy biological implant material in the present invention, the specific composition is Ca 10.5%, the rest is Mg, and the impurity elements in the alloy are Fe≤0.0005%, Ni≤0.0005%, Cu ≤0.001%, the total amount of impurity elements ≤0.005%, the raw materials are 99.99% Mg, 99.99% Ca, and the raw materials are cleaned with acid and alkali and dried.

[0033] The preparation of Mg-Ca alloy is smelted by low-carbon steel crucible without Ni, and the inner wall of the crucible is coated with BN. When the crucible is heated to 650°C, pure Mg is added for melting, and Ar+0.2%SF is used. 6 Melting under protection; when the pure Mg is completely melted and the temperature rises to 680°C, pure Ca is pressed into the Mg melt with a graphite bell jar, and then the temperature is raised to 710°C, and the stirring and purification treatment is carried out by rotary blowi...

Embodiment 2

[0038] Alloy raw materials are configured according to the mass percentage composition of each component in the magnesium alloy biological implant material in the present invention, the specific composition is Ca 4.5%, the rest is Mg, and the impurity elements in the alloy are Fe≤0.0005%, Ni≤0.0005%, Cu ≤0.001%, the total amount of impurity elements ≤0.005%, the raw materials are 99.99% Mg, 99.99% Ca, and the raw materials are cleaned with acid and alkali and dried.

[0039] The preparation of Mg-Ca alloy is smelted by low-carbon steel crucible without Ni, and the inner wall of the crucible is coated with BN. When the crucible is heated to 650°C, pure Mg is added for melting, and Ar+0.2%SF is used. 6 Melting under protection; when the pure Mg is completely melted and the temperature rises to 690°C, use a graphite bell jar to press pure Ca into the Mg melt, then raise the temperature to 730°C, use rotary jetting for stirring and purification treatment, and the rotary jetting gas...

Embodiment 3

[0044] Carry out alloy raw material configuration according to the mass percent composition of each composition in the magnesium alloy biological implant material among the present invention, its concrete composition is Zn 4.5%, Ca 1.2%, the rest is Mg, the impurity element Fe≤0.0005% in the alloy, Ni ≤0.0005%, Cu≤0.001%, the total amount of impurity elements ≤0.005%, according to the calculation of this alloy ratio, the alloy raw material is configured, and the Mg-Zn-Ca magnesium alloy raw material adopts 99.99% Mg, 99.99% Zn and 99.99% Ca, and The raw materials are cleaned with acid and alkali and dried.

[0045] The preparation of Mg-Zn-Ca alloy is smelted in a low-carbon steel crucible without Ni, and the inner wall of the crucible is coated with BN. When the crucible is heated to 650 ° C, pure Mg is added for melting, and Ar+0.2% SF is used. 6 Melting under protection; when the pure Mg is completely melted and the temperature rises to 680°C, add pure Zn; Injection is use...

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Abstract

The invention relates to a degradable magnesium alloy bio-implantation material which is characterized by consisting of the following components in percentage by mass: 0-12% of Zn, 0-10.5% of Ca and the balance of Mg and unavoidable impurities carried by the raw materials, wherein the total content of Zn and Ca is higher than or equal to 1.0%; the total content of unavoidable impurities is higher than or equal to 0.005%; in the unavoidable impurities, the content of Fe is lower than or equal to 0.0005%, the content of Ni is lower than or equal to 0.0005%, and the content of Cu is lower than or equal to 0.001%; and the invention also relates to a preparation method of the degradable magnesium alloy bio-implantation material. The degradable magnesium alloy bio-implantation material provided by the invention is non-toxic to a human body, has good corrosion resistance and good strength, and is suitable to be used for preparing magnesium alloy bio-implantation devices such as bone nails, bone plates and cardiovascular stents.

Description

technical field [0001] The invention relates to a biomedical alloy material, in particular to a biodegradable magnesium alloy bioimplantation material and a preparation method thereof. Background technique [0002] At present, the implant materials mainly used clinically include stainless steel, titanium and titanium alloy, Co-Cr alloy, etc., but the clinical application of these materials has the following problems: (1) release of toxic metal ions or particles due to corrosion cause inflammation; (2) the elastic modulus of metal materials is much higher than that of human bone, which has a great "stress shielding" effect on local bone tissue, which may lead to the possibility of natural bone function degradation or even atrophy; (3 ) materials such as stainless steel, titanium and titanium alloys are biologically inert materials, which cannot be degraded in the body. When used as temporary implant materials such as vascular stents, bone nails, bone plates, and bone needles,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C22C23/00C22C23/04C22F1/06A61L27/04
CPCA61L27/04C22C23/00C22C23/04C22F1/06
Inventor 任政黄原定朱秀荣李建舫张潇谭锁奎连付奎
Owner CHINA WEAPON SCI ACADEMY NINGBO BRANCH
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