CN1887360A - Biodegradable magnesium alloy blood vessel rack - Google Patents
Biodegradable magnesium alloy blood vessel rack Download PDFInfo
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- CN1887360A CN1887360A CNA2006101094213A CN200610109421A CN1887360A CN 1887360 A CN1887360 A CN 1887360A CN A2006101094213 A CNA2006101094213 A CN A2006101094213A CN 200610109421 A CN200610109421 A CN 200610109421A CN 1887360 A CN1887360 A CN 1887360A
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Abstract
The biodegradable magnesium alloy blood vessel rack consists of magnesium in 60-95 wt% and other metals, including RE, for the rest. Metal magnesium as the basic material has excellent tissue compatibility and blood compatibility, and the added other metal, including RE, elements raise and improve the comprehensive performance, especially mechanical strength, plasticity, degradability and biocompatibility. The magnesium alloy blood vessel rack has tensile strength of 200-300 MPa, elastic module of 10-50 GPa, elongation at break of 2-10%and degrading half life of 6-18 weeks. Most of the degraded metal ions are drained through renal tubules while small part being utilized by human body.
Description
Technical field
The present invention relates to intravascular stent, specifically, is a kind of people of being applied to body-centered, cerebrovascular biodegradable magnesium alloy blood vessel rack, belongs to biomedical engineering field.
Technical background
At first carried out the research of PTCA art (percutaneous coronary intracavity urethroptasty) abroad in 1977, domestic the first PTCA finished in 1984, its mechanism of action is that foley's tube is sent to the coronary artery pathological changes position, the full sacculus of pressurization, narrow blood vessel section internal diameter is increased, thereby improve blood supply of cardiac muscle.The coronary stent art grows up on the PTCA basis, metal rack is compressed in the sacculus upper support in pathological changes or narrow coronary artery inwall, make blood vessel wall narrow or that subside be expanded to the technology of normal condition, be reliable for effect in the present coronary heart disease treatment, method is easy, traumatic interventional therapeutic technique little, easy for patients to accept.
What be most widely used clinically at present is metal rack, and ideal metal rack should have following characteristics: 1) have persistent radial support power, the elastical retraction of treatment of vascular wall; 2) have good pliability, be convenient to pass through smoothly crooked blood vessel, send to diseased region; 3) have good blood compatibility, the blood coagulation reaction does not take place after the placement form thrombosis; 4) have the favorable tissue compatibility, do not cause immunological rejection and inflammatory reaction after the placement, do not promote the hypertrophy of inner membrance, cause the restenosis of blood vessel; 5) has good visuality under the X ray.
The main material that is used at present to make intravascular stent both at home and abroad is rustless steel, Ti-Ni alloy and cochrome, but these permanent metal racks are in secular implantation process, can there be the following shortcoming: behind reconstructing blood vessel, metal rack still remains in blood vessel as permanent implant, become unidirectional side effect foreign body with the unmatched tensile physical stimulation of blood vessel, secular stimulation causes the growth disorder of vascular endothelial cell, simultaneously also can cause partial chronic inflammatory reaction, so intravascular stent can disappear preferably after finishing its supporting role.Though these metal racks can temporarily satisfy clinically needs in present stage, but in the long run, development is biodegradable, have a kind of trend that the vascular stent material of high-biocompatibility and organizational integration has more become the vascular stent material development.Some biodegradable high molecular polymers have caused a lot of researchers' attention, but because the plastic deformation point of polymer itself is uncertain, the radial support power of the support of making is less, so need bigger volume to be suitable for it, be easy to cause acute or chronic inflammatory reaction simultaneously as the required mechanics requirement of intravascular stent.Therefore developing biodegradable metal rack is one of important direction that becomes present stage intravascular stent research.
Summary of the invention
Purpose of the present invention is exactly to provide a kind of biodegradable magnesium alloy blood vessel rack at the metal rack caused problem of not degrading in vivo, and this support had both kept metal material good mechanical performance, had biodegradability simultaneously in vivo again.
Magnesium alloy is a kind of biodegradable metal material, just begins to be used for bone tissue restoration and plastic surgery as far back as the thirties in last century, still because the degradation rate of pure magnesium is too fast, thereby produces a large amount of hydrogen, has limited its application.But along with the development of alloy technology, more alloying element is found and uses, thereby degradable magnesium alloy is re-recognized by people again.The mechanism of degradation of magnesium alloy is as follows:
Studies show that, magnesium alloy has excellent biological compatibility and good mechanical performance, some other the metallic element and the adding of rare earth element make its physical and chemical performance and biological property improve and improve, and have especially solved the too fast shortcoming of magnesium alloy degradation in vivo.Studies show that the degradation rate of magnesium alloy is main relevant with its alloying component and residing physiological environment.Report has been arranged, will be used for the zoopery of pig based on the intravascular stent of magnalium, experimental result finds that the biocompatibility of magnesium alloy is very good, has great application potential.Various used for magnesium alloy is in bone simultaneously, and cartilage and other integer material have all shown excellent biological compatibility.
Method of the present invention realizes by following technology:
Biodegradable magnesium alloy blood vessel rack, its percentage by weight consists of: the content of magnesium is 60-95%, all the other are metallic element and rare earth element.
Utilize the biodegradable of magnesium metal, it is prepared into a kind of people of being applied to body-centered, cerebrovascular biodegradable tubular bracket material, be that with the matrix material of magnesium metal as support, this class material has the favorable tissue compatibility and blood compatibility.
The magnesium alloy that intravascular stent of the present invention is used, by adding a certain proportion of other metallic element and rare earth element with good biocompatibility, in order to improve and to improve its comprehensive function, especially can adjust its mechanical strength, plasticity, degradability and bio-compatible in the larger context.
The magnesium alloy that intravascular stent of the present invention is used by adding some other metallic element, can play the effect of crystal grain thinning, thereby can improve the mechanical property of metal, regulates its degradation property simultaneously.
The magnesium alloy that intravascular stent of the present invention is used, by adding the rare earth element that some have biocompatibility, thereby make magnesium alloy be strengthened, and then the elastic modelling quantity and the plasticity of regulating alloy, improve the high-temperature behavior and the corrosion resistance of alloy, improve the machinability of magnesium alloy and the degradation rate of adjusting magnesium alloy.
The present invention is by the content of adjusting metallic element and the ratio of rare earth element interpolation, make the mechanical property of magnesium alloy obtain stable control, concrete for the scope of hot strength be 200-300Mpa: elastic modelling quantity is 10-50Gpa: elongation at break is 2-10%, meets the requirement of intravascular stent.
Content and the rare earth element ratio of adding of the present invention by regulating metallic element makes the degradation half life of magnesium alloy can be controlled at 6-18 week, the metal ion that degraded generates except that small part by the human body utilization, most of filtration by renal tubules is got rid of external.
Therefore, the degradable magnesium alloy system that the present invention proposes has excellent biological compatibility and excellent mechanical property, can satisfy the preparation needs of intravascular stent.
The specific embodiment
Embodiment 1:
A kind of biodegradable magnesium alloy blood vessel rack, its percentage by weight consists of: zinc 5%-8%; Calcium 0.5-5%; Zirconium 1%-3%; Neodymium 1%-3%; Niobium 0-3%, all the other are magnesium.Its physical and chemical performance, especially degradable performance can be regulated by the metallic element with good biocompatibility that adds other; Especially the degradable performance can be regulated by the rare earth element with good biocompatibility that adds other; Its biocompatibility can be regulated by the metallic element with good biocompatibility and the rare earth element that add other; Its processability can be regulated by the metallic element with good biocompatibility that adds other.
Embodiment 2:
A kind of biodegradable magnesium alloy blood vessel rack, its percentage by weight consists of: zinc 7%; Calcium 0.5%; Zirconium 1%; Neodymium 1%; All the other are magnesium.Through further being processed into section bar, the physical property that records this material is: hot strength is 220Mpa; Elastic modelling quantity is 20Gpa; Elongation at break is 8%; The external degradation half-life was 8 weeks.
Embodiment 3:
A kind of biodegradable magnesium alloy blood vessel rack, its percentage by weight consists of: zinc 5%; Calcium 2%; Zirconium 3%; Neodymium 3%; Niobium 3%, all the other are magnesium.Through further being processed into section bar, the physical property that records this material is: hot strength is 270Mpa; Elastic modelling quantity is 35Gpa; Elongation at break is 5%; The external degradation half-life was 12 weeks.
Embodiment 4:
A kind of biodegradable magnesium alloy blood vessel rack, its percentage by weight consists of: zinc 8%; Calcium 5%; Zirconium 3%; Neodymium 3%; Niobium 3%, all the other are magnesium.Through further being processed into section bar.The physical property that records this material is: hot strength is 300Mpa; Elastic modelling quantity is 40Gpa; Elongation at break is 2%; The external degradation half-life was 16 weeks.
Embodiment 5:
To carry out external biological assessment by the magnesium alloy blood vessel rack material that embodiment 3 obtains, experiment content comprises cytotoxicity, sensitization, zest, genetoxic, general toxicity, molten/projects such as blood coagulation, experimental result shows, this material does not have significant cytotoxicity to vascular smooth muscle cell, there are not tangible sensitization, zest and genetoxic, molten/blood coagulation experimental result shows that the alloy material that obtains has obviously anticoagulation function.Every performance functional parameter of the magnesium alloy bracket material that obtains in a word, all meets the requirement of national product standard and relevant standard.
Embodiment 6:
The body that will be carried out dog by the intravascular stent that embodiment 3 obtains is implanted into experiment, and experimental result shows that the intravascular stent that obtains has good visual performance under X-ray, has simultaneously and has good compliance, and the bend handling capacity is strong; All within normal scope, do not see especially that magnesium ion concentration has obvious variation in the index of the hematological examination of different implantation time points.1; 3; Carried out pathology section examination after putting to death animal in 6 months, the result shows that implant site does not have tangible inflammatory reaction to take place, the formation of fiber kystis is less, and the degraded of material is obvious, especially after 6 months, the most of degraded of material does not significantly exert an influence to tissue.
Claims (5)
1, biodegradable magnesium alloy blood vessel rack, its percentage by weight consists of: the content of magnesium is 60-95%, all the other are metallic element and rare earth element.
2, the degradable magnesium alloy blood vessel rack described in claim 1, its percentage by weight consists of: zinc 5%-8%; Calcium 0.5-5%; Zirconium 1%-3%; Neodymium 1%-3%; Niobium 0-3%, all the other are magnesium.
3, the degradable magnesium alloy blood vessel rack described in claim 1, its percentage by weight consists of: zinc 7%; Calcium 0.5%; Zirconium 1%; Neodymium 1%; All the other are magnesium.
4, the degradable magnesium alloy blood vessel rack described in claim 1, its percentage by weight consists of: zinc 5%; Calcium 2%; Zirconium 3%; Neodymium 3%; Niobium 3%, all the other are magnesium.
5, the degradable magnesium alloy blood vessel rack described in claim 1, its percentage by weight consists of: zinc 8%; Calcium 5%; Zirconium 3%; Neodymium 3%; Niobium 3%, all the other are magnesium.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2006101094213A CN100409904C (en) | 2006-08-14 | 2006-08-14 | Biodegradable magnesium alloy blood vessel rack |
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| CNB2006101094213A CN100409904C (en) | 2006-08-14 | 2006-08-14 | Biodegradable magnesium alloy blood vessel rack |
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| CN1887360A true CN1887360A (en) | 2007-01-03 |
| CN100409904C CN100409904C (en) | 2008-08-13 |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101297777B (en) * | 2008-03-26 | 2010-06-09 | 江阴法尔胜佩尔新材料科技有限公司 | Preparation for processing biodegradable magnesium alloy intravascular stent |
| CN101185777B (en) * | 2007-12-14 | 2010-06-16 | 天津理工大学 | Biological degradable nano hydroxyapatite/magnesium alloy blood vessel inner bracket material |
| CN101085377B (en) * | 2007-06-11 | 2011-05-04 | 沈阳工业大学 | Process for forming magnesium alloy ultra-fine thin-wall tube used for degradable blood vessel bracket |
| CN102294054A (en) * | 2010-06-24 | 2011-12-28 | 乐普（北京）医疗器械股份有限公司 | Bioabsorbable compound stent and preparation method thereof |
| CN102438669A (en) * | 2009-04-10 | 2012-05-02 | 波士顿科学医学有限公司 | Bioerodible, implantable medical devices incorporating supersaturated magnesium alloys |
| CN105671391A (en) * | 2016-01-19 | 2016-06-15 | 周倩 | Full-degradable magnesium alloy and preparation method thereof |
| CN110144503A (en) * | 2019-05-07 | 2019-08-20 | 珠海中科先进技术研究院有限公司 | A kind of high-strength anticorrosion magnesium alloy and preparation method thereof |
| CN110423928A (en) * | 2018-02-09 | 2019-11-08 | 河南科技大学 | A kind of high-strength anti-flaming magnesium alloy |
| CN111228577A (en) * | 2020-01-15 | 2020-06-05 | 太原科技大学 | Medical magnesium alloy capable of being degraded in short term and preparation method thereof |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19731021A1 (en) * | 1997-07-18 | 1999-01-21 | Meyer Joerg | In vivo degradable metallic implant |
| DE10128100A1 (en) * | 2001-06-11 | 2002-12-19 | Hannover Med Hochschule | Medical implant used for humans and animals is made from magnesium alloy containing additions of rare earth metals and lithium |
| DE102004026104A1 (en) * | 2004-05-25 | 2005-12-15 | Restate Patent Ag | Implant to the vessel ligature |
| CN1792383A (en) * | 2005-12-22 | 2006-06-28 | 上海交通大学 | Bio-absorbable Mg-Zn-Ca three-elements magnesium alloy material |
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2006
- 2006-08-14 CN CNB2006101094213A patent/CN100409904C/en active Active
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101085377B (en) * | 2007-06-11 | 2011-05-04 | 沈阳工业大学 | Process for forming magnesium alloy ultra-fine thin-wall tube used for degradable blood vessel bracket |
| CN101185777B (en) * | 2007-12-14 | 2010-06-16 | 天津理工大学 | Biological degradable nano hydroxyapatite/magnesium alloy blood vessel inner bracket material |
| CN101297777B (en) * | 2008-03-26 | 2010-06-09 | 江阴法尔胜佩尔新材料科技有限公司 | Preparation for processing biodegradable magnesium alloy intravascular stent |
| CN102438669A (en) * | 2009-04-10 | 2012-05-02 | 波士顿科学医学有限公司 | Bioerodible, implantable medical devices incorporating supersaturated magnesium alloys |
| CN102438669B (en) * | 2009-04-10 | 2014-09-10 | 波士顿科学医学有限公司 | Bioerodible, implantable medical devices incorporating supersaturated magnesium alloys |
| CN102294054A (en) * | 2010-06-24 | 2011-12-28 | 乐普（北京）医疗器械股份有限公司 | Bioabsorbable compound stent and preparation method thereof |
| CN105671391A (en) * | 2016-01-19 | 2016-06-15 | 周倩 | Full-degradable magnesium alloy and preparation method thereof |
| CN105671391B (en) * | 2016-01-19 | 2020-08-04 | 周倩 | Fully-degradable magnesium alloy and preparation method thereof |
| CN110423928A (en) * | 2018-02-09 | 2019-11-08 | 河南科技大学 | A kind of high-strength anti-flaming magnesium alloy |
| CN110144503A (en) * | 2019-05-07 | 2019-08-20 | 珠海中科先进技术研究院有限公司 | A kind of high-strength anticorrosion magnesium alloy and preparation method thereof |
| CN111228577A (en) * | 2020-01-15 | 2020-06-05 | 太原科技大学 | Medical magnesium alloy capable of being degraded in short term and preparation method thereof |
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| CN100409904C (en) | 2008-08-13 |
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Assignee: Liaoning Biomedical Materials R&D Center Co., Ltd. Assignor: Dalian Fujing Medical Equipment Co., Ltd. Contract fulfillment period: 2008.12.1 to 2016.11.30 contract change Contract record no.: 2008210000086 Denomination of invention: Biodegradable magnesium alloy blood vessel rack Granted publication date: 20080813 License type: Exclusive license Record date: 2008.12.9 |
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Free format text: EXCLUSIVE LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2008.12.1 TO 2016.11.30; CHANGE OF CONTRACT Name of requester: LIAONING BIOLOGY MEDICINE MATERIALS RESEARCH CENTE Effective date: 20081209 |
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Owner name: LIAONING BIOLOGY MEDICINE MATERIALS RESEARCH CENTE Free format text: FORMER OWNER: DALIAN FUJING MEDICAL TREATMENT EQUIPMENTS CO., LTD. Effective date: 20090925 |
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Effective date of registration: 20090925 Address after: Guangming Street Jinzhou District of Dalian City, Liaoning Province, Han 811 Road No. Patentee after: Liaoning Biomedical Materials R&D Center Co., Ltd. Address before: Dalian Development Zone, Dalian, Liaoning Patentee before: Dalian Fujing Medical Equipment Co., Ltd. |
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Address after: Guangming Street Jinzhou District of Dalian City, Liaoning Province, Han Road No. 8-11 116100 Patentee after: LIAONING YINYI BIOTECHNOLOGY CO., LTD. Address before: Guangming Street Jinzhou District of Dalian City, Liaoning Province, Han Road No. 8-11 116100 Patentee before: Liaoning Biomedical Materials R&D Center Co., Ltd. |