CN102776435A - Degradable Fe-Mn-C ternary iron alloy material and its application - Google Patents
Degradable Fe-Mn-C ternary iron alloy material and its application Download PDFInfo
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Abstract
The invention relates to a biodegradable Fe-Mn-C ternary iron alloy material in the field of biological medical materials. The alloy material comprises the following components by weight: 1-45% of Mn, 0.5-2.5% of C, and the balance iron. In the invention, the characteristic that the metal iron can corrode in a human body environment so as to be biodegraded is utilized, and Mn and C elements are added into pure iron to improve the corrosion rate of the pure iron in an organism environment, so that after the material is implanted in the body, the degradation time can be shortened, the stimulation on the organism can be reduced, and the treatment effects of medical devices can be improved. The material provided in the invention has good biocompatibility and mechanical properties, as well as better MRI (magnetic resonance imaging) compatibility, thus being able to be used as an intravascular stent material.
Description
Technical field
The present invention relates to a kind of bio-medical material technical field, the specifically a kind of Fe-Mn-C of degradable in vivo ternary ferroalloy materials and application.
Background technology
Existing non-degradable intravascular stent; Like 316L stainless steel stent, Co base alloy bracket; At the intravital chronic injury that may cause blood vessel that retains for a long time of people; Later stage is prone to cause middle level atrophy, aneurysma formation and reactive intimal hyperplasia etc. of blood vessel, thereby is prone to cause the generation of restenosis in the blood vessel.The biodegradable intravascular stent can disappear from vivo degradation after the mechanics supporting role of accomplishing lesion vessels, thereby thoroughly avoids the generation of restenosis in the blood vessel.Polymer and magnesiumalloy are two types of degradable angiocarpy bracket materials of present broad research.Yet the problems such as degradation speed that the poor mechanical property of two kinds of materials and magnesiumalloy are too fast can't satisfy the clinical request for utilization of degradable blood vessel bracket material at present fully.Ferrous alloy has caused Materials science worker and clinician's interest gradually with its excellent comprehensive performance and biodegradability.
Iron has following advantage as the biodegradable stent material:
(1) iron is the intravital a kind of important trace element of people, and it is about 35 and 45mg/kg respectively at adult female and the intravital content of the male sex.The intravital metabolic processes of ferro element wide participation people comprises the transmission of synthetic, electronics of transportation, the DNA of oxygen.Consider the extensive distribution of iron in human body, and the extremely light weight and the degradation time that needs a fixed length of angiocarpy bracket self, ferrous alloy is a kind of degradable blood vessel bracket material that has potential application foreground.
(2) iron itself is exactly a kind of corrosion-prone metallic substance.Being exposed to ferrous materials member Yin Qiyi in atmosphere, the seawater medium is corroded and often all need carries out corrosionproof protection and handle.For degradable blood vessel bracket; Hope that clinically the support of implanting can guarantee the mechanical property integrity of support in 12 months; With respect to the generally degraded fully in 3-4 month of magnesiumalloy, the slower degradation speed of ferrous alloy self can satisfy this degraded requirement.
(3) mechanical property of excellence.The 316L stainless steel is the main flow material of the present angiocarpy bracket that uses clinically, and its excellent comprehensive mechanical properties is regarded as the golden standard of angiocarpy bracket.With respect to other degradable angiocarpy bracket material of developing, the mechanical property of ferrous alloy is near 316L.Especially its good plasticity can guarantee that intravascular stent can not rupture in process of expansion.
(4) be easy to observe.With respect to other degradable blood vessel bracket material, ferrous alloy has higher density, and is opaque under the X ray.Therefore follow up a case by regular visits in the process in support implantation and later stage, can observe intravascular stent situation in vivo through X ray easily.
As the degradable blood vessel bracket material, pure iron still is faced with the low excessively problem of degradation speed.There are some researches show that pure iron implanted 1 year the time, have only the slight corrosion in surface, thereby RT in vivo is long relatively, also is not a kind of ideal biodegradable stent material.In order to improve the degradation speed of pure iron, people seek to come development of new degradable ferrous alloy material through the method for alloying.Hermawan etc. have researched and developed the Fe-30Mn alloy, and it is compared with pure iron, have degradation speed faster, have received people's attention.Yet its degradation speed still can not satisfy the requirement of biodegradable stent material, remains further to be improved.
Summary of the invention
To the pure iron that exists in the prior art and Fe-30Mn alloy low excessively problem of degradation speed under the human body environment; The object of the present invention is to provide a kind of Fe-Mn-C ternary ferroalloy materials with higher biodegradation rate, another purpose is to provide a kind of material that is used for angiocarpy bracket, peripheral blood vessel support.
The technical scheme that the present invention adopts is following:
The present invention utilizes pure iron under the human body environment, the corrosive characteristic can take place, and through in pure iron, adding Mn and two kinds of alloying elements of C, preparation Fe-Mn-C ternary ferroalloy materials is realized its degraded and absorbed faster in vivo.According to mass percent, the component of Fe-Mn-C ternary iron alloy is: Mn:1-45%, and C:0.5-2.5%, surplus is an iron.
For obtaining the mechanical property of degradation speed and Geng Gao faster, the mass percent of ferrous alloy can further be optimized for Mn:30 ± 2%, C:1 ± 0.5%, and surplus is an iron.
The tensile strength of ferrous alloy of the present invention can reach more than the 900MPa, and ys is more than 300MPa, and unit elongation is more than 70%.High intensity can reduce the diameter of support twine, thereby further shorten support degradation time in vivo under the necessary anchorage force condition of support guaranteeing, and reduces the contact area between support and the surrounding tissue and reduce the hormesis to tissue.At the initial stage that saline water soaks, the degradation speed of this scope iron alloy is up to 0.20mm/year, and degradation speed drops to 0.15mm/year in the time of 14 days, all is significantly improved than pure iron and Fe-30Mn alloy.The hemolysis rate of ferroalloy materials of the present invention is 2.6%, satisfies the requirement of implanted medical device, and its blood plasma recalcification time is all long than the Fe-30Mn alloy with the dynamic clotting time simultaneously, shows good blood compatibility.The detected result that its 24h vat liquor and cell are united behind the cultivation 24h shows that the cytotoxicity of ferroalloy materials of the present invention is 1 grade, satisfies the biological safety requirement of implanted medical device.In addition, this iron alloy is single austenite structure, presents paramagnetism, have than 316L stainless steel and the lower susceptibility of Fe-30Mn alloy, thereby the compatible meeting of its MRI (zeugmatography) is better.
The present invention is except having higher degradation speed with the vivo degradation that shortens support the time, also has excellent biological compatibility, excellent mechanical property and lower magnetic, can be used for the PCI field, like angiocarpy bracket, peripheral blood vessel support etc.
Description of drawings
Fig. 1 is embodiment 1Fe-30Mn-1C alloy and Fe-30Mn alloy and the stainless magnetzation curve of 316L;
Fig. 2 is embodiment 1Fe-30Mn-1C alloy and the electrochemical impedance spectroscopy of Fe-30Mn in 37 ℃ of saline water;
Fig. 3 is the XRD figure spectrum of embodiment 1Fe-30Mn-1C ternary alloy.
Embodiment
Elaborate in the face of embodiments of the invention down: present embodiment provided detailed embodiment and concrete operating process, but protection scope of the present invention is not limited to following embodiment being to implement under the prerequisite with technical scheme of the present invention.
Fe-Mn-C ternary iron alloy, the quality percentage composition is respectively: Mn:30%, C:1%, surplus is Fe, is expressed as Fe-30Mn-1C.Process the iron alloy ingot casting through vacuum induction melting, ingot casting forges behind 1050 ℃ of insulation 1h, forges the back air cooling, finally is swaged into the pole of Ф 25mm.
Iron alloy after forging is processed into the tension specimen of M10 Ф 5 * 25mm; Mechanical property according to GB/T 228-2002 standard test material on AG-100kNG mechanical test machine; Obtaining its tensile strength is 1010MPa, and ys is 373MPa, and unit elongation is 88%.Electrochemical impedance spectroscopy in 37 ℃ of saline water is as shown in Figure 1, and with Fe-30Mn alloy phase ratio, the Fe-30Mn-1C alloy has lower polarization resistance, shows that it has higher degradation speed in physiological environment.Immersion test in saline water shows that the degradation speed of this alloy is up to 0.20mm/year, and degradation speed drops to 0.15mm/year in the time of 14 days, has higher degradation speed.According to the evaluation method of ISO10993, the cytotoxicity of this material is 1 grade, and hemolysis rate is 2.59 ± 0.44%.This material has degradation speed, excellent biological compatibility and mechanical property faster.
Be illustrated in figure 2 as the XRD figure spectrum of Fe-30Mn-1C ternary alloy, this iron alloy is single austenite structure.
Be illustrated in figure 3 as Fe-30Mn-1C alloy and Fe-30Mn alloy and the stainless magnetzation curve of 316L, the result shows: the present invention has than 316L stainless steel and the lower susceptibility of Fe-30Mn alloy, thereby the compatible meeting of its MRI is better.
Embodiment 2
Fe-Mn-C ternary iron alloy, the quality percentage composition is respectively: Mn:10%, C:0.8%, surplus is Fe.Process the iron alloy ingot casting through vacuum induction melting, ingot casting forges behind 1050 ℃ of insulation 1h, forges the back air cooling, finally is swaged into the pole of Ф 25mm.
Iron alloy after forging is processed into the tension specimen of M10 Ф 5 * 25mm; Mechanical property according to GB/T 228-2002 standard test material on AG-100kNG mechanical test machine; Obtaining its tensile strength is 980MPa, and ys is 310MPa, and unit elongation is 80%.Immersion test in saline water shows that the degradation speed of this alloy is up to 0.18mm/year, and degradation speed drops to 0.13mm/year in the time of 14 days, has higher degradation speed.According to the evaluation method of ISO10993, the cytotoxicity of present embodiment material is 1 grade, and hemolysis rate is 2.20 ± 0.19%.The present embodiment material has degradation speed, excellent biological compatibility and mechanical property faster.
Embodiment 3
Fe-Mn-C ternary iron alloy, the quality percentage composition is respectively: Mn:40%, C:2%, surplus is Fe.Process the iron alloy ingot casting through vacuum induction melting, ingot casting forges behind 1050 ℃ of insulation 1h, forges the back air cooling, finally is swaged into the pole of Ф 25mm.
Iron alloy after forging is processed into the tension specimen of M10 Ф 5 * 25mm; Mechanical property according to GB/T 228-2002 standard test material on AG-100kNG mechanical test machine; Obtaining its tensile strength is 1035MPa, and ys is 320MPa, and unit elongation is 75%.Immersion test in saline water shows that the degradation speed of this alloy is up to 0.23mm/year, and degradation speed drops to 0.18mm/year in the time of 14 days, has higher degradation speed.According to the evaluation method of ISO10993, the cytotoxicity of present embodiment material is 1 grade, and hemolysis rate is 2.69 ± 0.57%.The present embodiment material has degradation speed, excellent biological compatibility and mechanical property faster.
Embodiment 4
Fe-Mn-C ternary iron alloy, the quality percentage composition is respectively: Mn:2%, C:2.1%, surplus is Fe.Process the iron alloy ingot casting through vacuum induction melting, ingot casting forges behind 1050 ℃ of insulation 1h, forges the back air cooling, finally is swaged into the pole of Ф 25mm.
Iron alloy after forging is processed into the tension specimen of M10 Ф 5 * 25mm; Mechanical property according to GB/T 228-2002 standard test material on AG-100kNG mechanical test machine; Obtaining its tensile strength is 960MPa, and ys is 305MPa, and unit elongation is 73%.Immersion test in saline water shows that the degradation speed of this alloy is up to 0.19mm/year, and degradation speed drops to 0.14mm/year in the time of 14 days, has higher degradation speed.According to the evaluation method of ISO10993, the cytotoxicity of this material is 1 grade, and hemolysis rate is 2.41 ± 0.35%.This material has degradation speed, excellent biological compatibility and mechanical property faster.
Embodiment 5
Fe-Mn-C ternary iron alloy, the quality percentage composition is respectively: Mn:30%, C:0.8%, surplus is Fe.Process the iron alloy ingot casting through vacuum induction melting, ingot casting forges behind 1050 ℃ of insulation 1h, forges the back air cooling, finally is swaged into the pole of Ф 25mm.
Iron alloy after forging is processed into the tension specimen of M10 Ф 5 * 25mm; Mechanical property according to GB/T 228-2002 standard test material on AG-100kNG mechanical test machine; Obtaining its tensile strength is 1020MPa, and ys is 350MPa, and unit elongation is 85%.Immersion test in saline water shows that the degradation speed of this alloy is up to 0.22mm/year, and degradation speed drops to 0.16mm/year in the time of 14 days, has higher degradation speed.According to the evaluation method of ISO10993, the cytotoxicity of this material is 1 grade, and hemolysis rate is 2.63 ± 0.51%.This material has degradation speed, excellent biological compatibility and mechanical property faster.
Embodiment 6
Fe-Mn-C ternary iron alloy, the quality percentage composition is respectively: Mn:25%, C:1.5%, surplus is Fe.Process the iron alloy ingot casting through vacuum induction melting, ingot casting forges behind 1050 ℃ of insulation 1h, forges the back air cooling, finally is swaged into the pole of Ф 25mm.
Iron alloy after forging is processed into the tension specimen of M10 Ф 5 * 25mm; Mechanical property according to GB/T 228-2002 standard test material on AG-100kNG mechanical test machine; Obtaining its tensile strength is 1030MPa, and ys is 290MPa, and unit elongation is 76%.Immersion test in saline water shows that the degradation speed of this alloy is up to 0.21mm/year, and degradation speed drops to 0.11mm/year in the time of 14 days, has higher degradation speed.According to the evaluation method of ISO10993, the cytotoxicity of this material is 1 grade, and hemolysis rate is 2.19 ± 0.39%.This material has degradation speed, excellent biological compatibility and mechanical property faster.
Claims (3)
1. biodegradable Fe-Mn-C ternary ferroalloy materials is characterized in that according to mass percent, the component that comprises is: Mn:1-45%, and C:0.5-2.5%, surplus is an iron.
2. according to the described biodegradable Fe-Mn-C of claim 1 ternary ferroalloy materials, it is characterized in that according to mass percent, the component that comprises is: Mn:30 ± 2%, C:1 ± 0.5%, surplus is an iron.
3. according to the application of claim 1 or 2 described biodegradable Fe-Mn-C ternary ferroalloy materials; It is characterized in that described biodegradable Fe-Mn-C ternary ferroalloy materials can be used as the material of bio-medical material medium vessels inner support and peripheral blood vessel support.
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Cited By (12)
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| KR101395141B1 (en) | 2013-05-29 | 2014-05-15 | 대구가톨릭대학교산학협력단 | Manufacturing method of alloy composition for bio-material |
| CN104694848A (en) * | 2015-01-28 | 2015-06-10 | 燕山大学 | Biodegradable quaternary iron-based alloy material and preparation method thereof |
| CN104711473A (en) * | 2015-01-28 | 2015-06-17 | 燕山大学 | Nonmagnetic biomedical implant material and preparation method thereof |
| WO2016023383A1 (en) * | 2014-08-14 | 2016-02-18 | 燕山大学 | Low-temperature high-strength-and-ductility high manganese steel, and high manganese steel plate and high manganese steel tube manufacturing process |
| CN107648676A (en) * | 2017-11-08 | 2018-02-02 | 谭思暄 | A kind of degradable iron-based angiocarpy bracket material and preparation method thereof |
| CN108677099A (en) * | 2018-04-17 | 2018-10-19 | 西南大学 | Medical degradable Fe-Mn-Ag alloy materials and preparation and application |
| CN109811265A (en) * | 2017-11-22 | 2019-05-28 | 中国科学院金属研究所 | A kind of Fe-Mn-Cu-C system alloy and its medical application |
| CN110477982A (en) * | 2019-07-24 | 2019-11-22 | 中国科学院金属研究所 | Anti- calculus anastomosis staple of degradable antibacterial suitable for urinary system and preparation method thereof |
| CN111235476A (en) * | 2018-11-29 | 2020-06-05 | 中国科学院金属研究所 | Degradable anti-infection and anti-calculus Fe-Cu series alloy suitable for urinary implant material |
| CN111411306A (en) * | 2019-01-07 | 2020-07-14 | 任柯睿 | Absorbable iron alloy and application thereof |
| CN113755738A (en) * | 2021-09-10 | 2021-12-07 | 广东粤海华金科技股份有限公司 | Degradable iron-based alloy material and preparation method and application thereof |
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| CN108677099A (en) * | 2018-04-17 | 2018-10-19 | 西南大学 | Medical degradable Fe-Mn-Ag alloy materials and preparation and application |
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