Fe-Mn-Cu-C system alloy and medical application thereof

A technology of fe-mn-cu-c and alloy, which is applied in the application field of implanted device materials, can solve the problems of increasing wound healing time, tissue structure deformation, affecting surgical effect, etc., to achieve the function of inhibiting vascular restenosis, reducing or Bacterial infection, the effect of increasing the corrosion rate

Active Publication Date: 2019-05-28
INST OF METAL RESEARCH - CHINESE ACAD OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are the following main problems in the clinical application of biomedical metal materials: First, the existing metal materials that can be used as wires or scaffolds, such as titanium alloys, stainless steel, and Co-based alloys, are non-degradable and absorbable metal materials. , long-term residence in the human body can easily lead to a series of adverse reactions such as inflammation, delayed healing, sensitization, and carcinogenicity, and cause potential risk factors for patients
After the patient's tissue is repaired or healed, a second operation is required to remove it, which brings additional surgical risks, economic pressure and physical pain to the patient
Second, the existing implanted metal materials are all inert materials and have no biological activity. Even under the premise of strict aseptic operation and systemic preventive anti-inflammatory treatment, bacterial infection will still occur
Bacterial infection is usually difficult to control, recurrent, increases wound healing time, affects the effect of surgery, brings great physical and mental pain and heavy economic burden to patients and their families
Third, the existence of metal implants will cause metal artifacts in imaging observations, resulting in blurred effects in the corresponding areas, deformation of tissue structures, etc.
In addition, if the metal is magnetic, there are potential risks, such as: implant heating, displacement, etc.

Method used

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  • Fe-Mn-Cu-C system alloy and medical application thereof
  • Fe-Mn-Cu-C system alloy and medical application thereof
  • Fe-Mn-Cu-C system alloy and medical application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0032] In this embodiment, the Fe-Mn-Cu-C quaternary Fe alloy has the following mass percentages: Mn: 28%, C: 0.8%, Cu: 1.0%, and the remainder is Fe, expressed as Fe-28Mn-0.8 C-1Cu. The Fe alloy ingot was made by vacuum induction melting, and after the ingot was kept at 1100°C for 1 hour, it was forged into a Φ20mm round bar.

[0033] According to the GB / T 228-2002 standard, the Fe alloy bar is processed into a standard tensile sample, and its tensile strength is 1130MPa, yield strength is 453MPa, and elongation is 83%. According to the antibacterial test standard GB / T2591, the alloy has a strong bactericidal function, and the bactericidal rates for Staphylococcus aureus and Escherichia coli are 96.0% and 98.1%, respectively, seefigure 1 . According to the ASMT-G31 metal immersion standard, the degradation rate can reach 0.45mm / a when soaked in normal saline for 7 days, and the degradation rate drops to 0.35mm / a after 14 days. According to the ISO-10993 biological evaluatio...

Embodiment 2

[0035] In this embodiment, the Fe-Mn-Cu-C quaternary Fe alloy has the following mass percentages: Mn: 20%, C: 0.5%, Cu: 2.0%, and the rest is Fe, expressed as Fe-20Mn-0.5 C-2Cu. The Fe alloy ingot was made by vacuum induction melting, and the ingot was forged into a Φ20mm round bar after being kept at 1100°C for 1h.

[0036] According to the GB / T 228-2002 standard, the Fe alloy bar is processed into a standard tensile sample. The tensile strength is 1177MPa, the yield strength is 493MPa, and the elongation is 80%. According to the antibacterial test standard GB / T2591, it is measured that the alloy has a strong bactericidal function, and the bactericidal rates for Staphylococcus aureus and Escherichia coli are 99.2% and 99.9% respectively. According to the ASMT-G31 metal immersion standard, the degradation rate can reach 0.48mm / a when soaked in normal saline for 7 days, and the degradation rate drops to 0.39mm / a after 14 days. According to the ISO-10993 biological evaluation ...

Embodiment 3

[0038] In this embodiment, the Fe-Mn-Cu-C quaternary Fe alloy has the following mass percentages: Mn: 30%, C: 1.1%, Cu: 2.2%, and the rest is Fe, expressed as Fe-30Mn-1.1 C-2.2Cu. The Fe alloy ingot was made by vacuum induction melting, and the ingot was forged into a Φ20mm round bar after being kept at 1100°C for 1h.

[0039] According to the GB / T 228-2002 standard, the Fe alloy bar is processed into a standard tensile sample. The tensile strength is 1200MPa, the yield strength is 584MPa, and the elongation is 76%. According to the antibacterial test standard GB / T2591, it is measured that the alloy has a strong bactericidal function, and the bactericidal rates for Staphylococcus aureus and Escherichia coli are 99.9% and 99.9% respectively. According to the ASMT-G31 metal immersion standard, the degradation rate can reach 0.50mm / a when soaked in normal saline for 7 days, and the degradation rate drops to 0.43mm / a after 14 days. According to the ISO-10993 biological evaluatio...

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Abstract

The invention relates to the field of medical metal materials, in particular to an Fe-Mn-Cu-C system alloy and medical application thereof. The alloy comprises the components of, by weight, 10-35% ofMn, 0.2-5.0% of Cu, 0.2-1.5% of C, and the balance Fe. The feature that Fe corrodes in the human body environment and is biodegradable is used, the proper amount of Mn, Cu and C elements are added into the Fe, the Fe-Mn-Cu-C system alloy is prepared through casting and forging, and through the synergistic effect of the alloy elements, the mechanical property of the alloy and the corrosion rate ofthe alloy in the living organism environment can be improved, and the material has the various beneficial biological functions. The Fe-Mn-Cu-C system alloy having the mechanical property, degradationproperty and biological activity is especially suitable for implantation device materials in the medical field. Therefore, when products are designed, according to the different clinical applicability, the excellent properties of Fe-Mn-Cu-C materials are sufficiently given full play, and corresponding suture lines, anastomosis nails, cardiovascular stents, braided mesh supports and the like can beprepared.

Description

technical field [0001] The invention relates to the field of medical metal materials, in particular to an Fe-Mn-Cu-C alloy and its application as implantation device material in the medical field. Background technique [0002] Metal ultra-fine wires or tubes have important application value in the biomedical field, and can be used as materials such as sutures, staples, nerve guides, and stents. At present, there are the following main problems in the clinical application of biomedical metal materials: First, the existing metal materials that can be used as wires or scaffolds, such as titanium alloys, stainless steel, and Co-based alloys, are non-degradable and absorbable metal materials. , Long-term residence in the human body can easily lead to a series of adverse reactions such as body inflammation, delayed healing, sensitization, and carcinogenicity, and cause potential risk factors for patients. After the patient's tissue is repaired or healed, a second operation is req...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C22C38/04C22C38/16A61L31/14A61L31/02A61L31/16A61L17/06A61L17/00
Inventor 马政谭丽丽杨柯于晓明高明
Owner INST OF METAL RESEARCH - CHINESE ACAD OF SCI
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