CN109847113A - Pltine biodegradable angiocarpy bracket and preparation method thereof - Google Patents
Pltine biodegradable angiocarpy bracket and preparation method thereof Download PDFInfo
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- CN109847113A CN109847113A CN201910160171.3A CN201910160171A CN109847113A CN 109847113 A CN109847113 A CN 109847113A CN 201910160171 A CN201910160171 A CN 201910160171A CN 109847113 A CN109847113 A CN 109847113A
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- pltine
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Abstract
The present invention provides pltine biodegradable angiocarpy brackets, the bracket is made of zinc-copper alloy material, the component and mass percent of the zinc-copper alloy material: Zn70-80%, Cu4-9%, Fe1-2%, Ag0.2-0.5%, Nd0.1-0.2%, Gd0.05-0.1%, surplus Mg.The advantages of pltine of the present invention has mechanical property good, easy processing, corrosion-resistant excellent, good biocompatibility.
Description
Technical field
The invention belongs to artificial blood vessel bracket preparation technical field more particularly to a kind of pltine biodegradable painstaking effort
Pipe holder and preparation method thereof.
Background technique
In recent years, with the continuous improvement of people's living standards, the disease incidence of various cardiovascular diseases is just being in increase year by year
Trend.The World Health Organization expects the year two thousand thirty, will have about 23,600,000 people every year and die of cardiovascular disease.In fact, in
State's cardiovascular death rate occupies the first place of disease death composition already.
Charles Dotter and Melvin Judkins proposed the general of intravascular Interventional Treatment in 1964 first
It reads.1977, Gruentzig carried out first case percutaneous transluminal coronary angioplasty, and Sigwar was reported first time in 1986
The coronary stent of self expandable, 1987, balloon expandable stent was applied to human body for the first time.
Intravascular stent refers to that on the basis of the forming of lumen balloon expandable, it is narrow to reach support to be placed in inner support in lesion
Narrow occlusion section blood vessel reduces blood vessel elasticity retraction and moulding again, the purpose for keeping lumen blood flow unobstructed；Part inner support also has
The effect of pre- anti-restenosis；It is broadly divided into coronary artery bracket, cerebrovascular stent, renal artery stent, aortic stent etc..
First generation bracket is bare metal stent, it makes interventional therapy become safer (compared to simple balloon dilatation),
Vascular opening can be cleared with bracket at once when angiogenesis blocking, restenosis rate is about 10%-20%.It is main
Including metal tantalum, medical stainless steel and titanium alloy etc., but these metallic stent material non-degradables, if occurring after being implanted into human body
ISR (in-stent restenosis) needs to increase the degree of risk for causing restenosis in permanent retention body, or only passes through two
Secondary operation is taken out, and undoubtedly increases the pain of patient in this way.
Second generation intravascular stent DES is to carry drug (mainly thunder pa by being coated in the polymer of metal support surface
Mycin and related derivatives, taxol etc.), after bracket is placed in vessel inner lesion position, lead in drug auto polymerization object coating
The hyper-proliferative that the controlled release of type of elution inhibits smooth muscle cell to painstaking effort tube wall tissue is crossed, to inhibit in new life
The hyperplasia of film significantly reduces restenosis incidence, only 5%-10%.DES is mainly made of three parts, is metal respectively
As substrate, rapamycin and its derivative, taxol etc. are used as anti-smooth muscle cell proliferation drug, high molecular polymer conduct
Pharmaceutical carrier.The non-degradable metal material that bracket uses need to be chronically implanted in vivo, and there are greater risks.
Third generation intravascular stent is polymer biodegradable stent.The time that Restenosis occurs for intravascular stent is operation
6 months afterwards, ideal bracket should be completed support blood vessels within this time and make the mission of unobstructed blood, and after-poppet
It voluntarily degrades, is finally completely absorbed.After bracket absorbs, if necessary to secondary implantation, bracket can be reapposed in the original location.Branch
The material that frame uses is mainly degradable high polymer material PPDO or PLLA or PLGA or PCL etc..
Forth generation intravascular stent is metal biodegradable stent, and compare third generation polymer biodegradable stent, and intensity is higher,
With better supportive, and at the same time having the degradability of three generations's bracket, main material to be used is magnesium alloy materials.
Following table is the contrast effect of each generation intravascular stent:
In angiocarpy bracket field, by longitudinal comparison, degradable blood vessel support is fairly obvious, however existing drops
It solves in bracket, the drawbacks such as wherein that there is intensity is undesirable for the polymer biodegradable stent of the third generation, and supportive is undesirable, and
Polymer degradation bracket is easy to produce the formation that certain harmful substance be easy to cause thrombus during degradation, and there is one
Fixed risk, in 2017, formal dispatch proposed that polylactic acid bracket is used with caution U.S. FDA.And the magnesium alloy bracket of forth generation, although
Solve the undesirable drawback of third generation polylactic acid bracket intensity, since corrosion resistance of magnesium alloy can be poor, although by
Coating treatment, but still the problem that generally existing degradation speed is too fast, and magnesium alloy is in the mistake that degradation reaction occurs with blood
It is inevitably easy to produce certain gas in journey, be easy to cause other unknown risks.
Summary of the invention
In view of the problems of the above-mentioned prior art, the object of the present invention is to provide a kind of pltine biodegradable hearts
Intravascular stent and preparation method thereof.
The present invention is achieved through the following technical solutions above-mentioned purpose:
Pltine biodegradable angiocarpy bracket, the bracket are made of zinc-copper alloy material, the pltine
The component and mass percent of material: Zn70-80%, Cu4-9%, Fe1-2%, Ag0.2-0.5%, Nd0.1-0.2%,
Gd0.05-0.1%, surplus Mg.
Specifically, the component and mass percent of the zinc-copper alloy material: Zn70%, Cu9%, Fe2%, Ag0.5%,
Nd0.2%, Gd0.1%, surplus Mg.
Specifically, the component and mass percent of the zinc-copper alloy material: Zn80%, Cu4%, Fe1%, Ag0.2%,
Nd0.1%, Gd0.05%, surplus Mg.
Specifically, the component and mass percent of the zinc-copper alloy material: Zn75%, Cu6%, Fe1.5%,
Ag0.3%, Nd0.15%, Gd0.08%, surplus Mg.
The preparation method of pltine biodegradable angiocarpy bracket, includes the following steps:
The blank tubing of required specification is made in S1, technique of the zinc-copper alloy material Jing Guo melting, extruding, drawing；S2,
Pipe is made to the rack body of reticular structure by laser cutting parameter；
S3, electrolytic polishing process handle bracket, remove small burr；
The bracket prepared is cleaned 30-40min using purified water, then is placed in hydrogenperoxide steam generator by S4, and temperature is arranged
2-4h is impregnated within the scope of 60-80 DEG C, purified water is rinsed well after taking-up；
S5 immerses in the good rapamycin drug solution of pre-coordination, and 10-20h is impregnated in heating；
S6, taking-up are placed in household freezer -80 DEG C, freeze 2-3h.
Specifically, the bracket prepared is cleaned 35min using purified water, then be placed in hydrogenperoxide steam generator in step S4
In, setting temperature impregnates 3h within the scope of 70 DEG C, and purified water is rinsed well after taking-up.
Specifically, being immersed in the good rapamycin drug solution of pre-coordination, 15h. is impregnated in heating in step S5
Specifically, taking-up is placed in household freezer -80 DEG C in step S6,2.5h is freezed.
Compared with prior art, the beneficial effects of the present invention are: pltine has mechanical property good, easy processing, corrosion resistant
The advantages of losing excellent, good biocompatibility, tensile strength 165-225Mpa, elongation percentage 11-22% realize big portion after four weeks
Divide degradation, meets the requirement of biological safety.
Specific embodiment
Below just in conjunction with the embodiments, the embodiment of the present invention is described in further detail, so that the technology of the present invention
Scheme is more readily understood, grasps, but the present invention is not limited thereto.Experimental method described in following embodiments, such as without special theory
It is bright, it is conventional method；The reagent and material commercially obtain unless otherwise specified.
Embodiment 1:
Pltine biodegradable angiocarpy bracket, bracket are made of zinc-copper alloy material, the group of zinc-copper alloy material
Point and mass percent: Zn70%, Cu9%, Fe2%, Ag0.5%, Nd0.2%, Gd0.1%, surplus Mg.
Through detecting, the tensile strength 165Mpa of zinc-copper alloy material provided in this embodiment, elongation percentage 22%.According to GB/
T16886 experimental method carries out biological assessment to zinc-copper alloy material provided in this embodiment, and experiment shows zinc-copper alloy material
To stem cell in osteocyte and marrow without obvious cytotoxicity, no sensitization and toxicity.To the zinc-copper alloy material of the embodiment
White mouse experiment is carried out, the stenter to implant white mouse is cardiovascular, it is checked within postoperative 4 weeks, the degradation rate of the zinc-copper alloy material is
30%.Thrombus in stents incidence 11%.Arterial restenosis rate 9%.
Embodiment 2:
Pltine biodegradable angiocarpy bracket, bracket are made of zinc-copper alloy material, the group of zinc-copper alloy material
Point and mass percent: Zn80%, Cu4%, Fe1%, Ag0.2%, Nd0.1%, Gd0.05%, surplus Mg.
Through detecting, the tensile strength 225Mpa of zinc-copper alloy material provided in this embodiment, elongation percentage 11%.According to GB/
T16886 experimental method carries out biological assessment to zinc-copper alloy material provided in this embodiment, and experiment shows zinc-copper alloy material
To stem cell in osteocyte and marrow without obvious cytotoxicity, no sensitization and toxicity.To the zinc-copper alloy material of the embodiment
White mouse experiment is carried out, the stenter to implant white mouse is cardiovascular, it is checked within postoperative 4 weeks, the degradation rate of the zinc-copper alloy material is
38%.Thrombus in stents incidence 4%.Arterial restenosis rate 3%.
Embodiment 3:
Pltine biodegradable angiocarpy bracket, bracket are made of zinc-copper alloy material, the group of zinc-copper alloy material
Point and mass percent: Zn75%, Cu6%, Fe1.5%, Ag0.3%, Nd0.15%, Gd0.08%, surplus Mg.
Through detecting, the tensile strength 190Mpa of zinc-copper alloy material provided in this embodiment, elongation percentage 17%.According to GB/
T16886 experimental method carries out biological assessment to zinc-copper alloy material provided in this embodiment, and experiment shows zinc-copper alloy material
To stem cell in osteocyte and marrow without obvious cytotoxicity, no sensitization and toxicity.To the zinc-copper alloy material of the embodiment
White mouse experiment is carried out, the stenter to implant white mouse is cardiovascular, it is checked within postoperative 4 weeks, the degradation rate of the zinc-copper alloy material is
35%.Thrombus in stents incidence 7%.Arterial restenosis rate 6%.
Zinc is human body necessary microelement the most basic.Wherein, zinc can promote the update of cell, can enhance exempting from for human body
Epidemic disease ability maintains the growth and development of human body.Zinc is the ingredient of many protein, nucleic acid synthesizing enzyme, is the activity of hundreds of enzyme
Center.Zinc is insulin component again, is the key factor of normal activity of sustaining life.Therefore, zinc-containing alloy has good life
Object compatibility.Between ferrous alloy and magnesium base alloy, corrosion rate is most suitable for the corrosion degradation rate of kirsite simultaneously
Clinical application.
A small amount of copper is added, copper is the necessary beneficial microelement of human body, and the physiological function of copper mainly has as follows
Several aspects: 1) safeguarding normal hematopoietic function, shows following two aspect: 1. promoting the absorption and transport of iron；2. covellite egg
The white synthesis that can promote ferroheme and hemoglobin.2) the normal of bone, blood vessel and skin is safeguarded.Cuprase lysyloxidase promotees
Into the crosslinking of bone, blood vessel and skin collagen and elastin laminin.3) health of central nervous system is safeguarded.4) body cell is protected
From the murder by poisoning of superoxide ion.5) copper ion can inducing endothelial growth factor, promote the proliferation of endothelial cell, accelerate blood vessel again
Raw process, but prevent the hyper-proliferative of smooth muscle cell；And energy inhibition thrombosis and other effects, it can effectively reduce intravascular stent etc.
The restenosis rate caused after implantation, copper ion can promote the formation and growth of bone tissue by the deposition of promotion ossein,
Have and promotes osteogenic action.6) copper ion has bactericidal effect, this has important value for implantation instrument, can be to avoid device
Cause to infect after part implantation, to mitigate the pain and trouble of patient.7) other: copper is to cholesterol metabolic, cardiac muscle cell's oxygen
Change many physiology, biochemistry and the pathophysiological process such as metabolism, human body defensive enginery, hormone secretion also to have an impact.Therefore, copper is selected
Element is the main addition alloy element of zinc-containing alloy, and the intensity and plasticity that on the one hand increase zinc play the work of Toughened Materials
With for another aspect material during degradation, the release of micro copper ion is that have above-mentioned beneficial biological function to human body
It can effect.
It is added micro other Mg, Fe, Ag simultaneously, Nd, Gd element, these elements can improve the mechanical property and life of alloy
Object compatibility performance, and can increase tensile strength, yield strength with the corrosion degradation rate of appropriate regulation alloy and obtain more preferable
Elongation percentage.
Embodiment 4:
The preparation method of pltine biodegradable angiocarpy bracket is passed through using the zinc-copper alloy material of above-mentioned composition
Melting, extruding, drawing technique the blank tubing of required specification is made；Netted knot is made in pipe using laser cutting parameter
The rack body of structure；Bracket is handled using electrolytic polishing process, remove small burr and obtains smoother surface
Finish；The bracket prepared is cleaned into 30-40min using purified water, is specifically set as 35min, then be placed in hydrogen peroxide
In solution, setting temperature impregnates 2-4h within the scope of 60-80 DEG C, and the specific temperature that is arranged impregnates 3h within the scope of 70 DEG C, takes out
Purified water is rinsed well afterwards；It immerses in the good rapamycin drug solution of pre-coordination, 10-20h is impregnated in heating, specific to heat
Impregnate 15h；Taking-up is placed in household freezer -80 DEG C, freezes 2-3h, specifically freezes 2.5h.
By rapamycin drug coating processing, effect is after stenter to implant blood vessel by slowly controlled by drug
It discharges to painstaking effort tube wall tissue and inhibits the hyper-proliferative of smooth muscle cell, to inhibit the hyperplasia of new intima, inhibit thrombus
Formation, significantly reduce restenosis incidence.
Above-described is only some embodiments of the present invention.For those of ordinary skill in the art, not
Under the premise of being detached from the invention design, various modifications and improvements can be made, these belong to protection model of the invention
It encloses.
Claims (8)
1. pltine biodegradable angiocarpy bracket, the bracket are made of zinc-copper alloy material, it is characterised in that: described
The component and mass percent of zinc-copper alloy material: Zn70-80%, Cu4-9%, Fe1-2%, Ag0.2-0.5%, Nd0.1-
0.2%, Gd0.05-0.1%, surplus Mg.
2. pltine biodegradable angiocarpy bracket according to claim 1, it is characterised in that: the pltine
The component and mass percent of material: Zn70%, Cu9%, Fe2%, Ag0.5%, Nd0.2%, Gd0.1%, surplus Mg.
3. pltine biodegradable angiocarpy bracket according to claim 1, it is characterised in that: the pltine
The component and mass percent of material: Zn80%, Cu4%, Fe1%, Ag0.2%, Nd0.1%, Gd0.05%, surplus Mg.
4. pltine biodegradable angiocarpy bracket according to claim 1, it is characterised in that: the pltine
The component and mass percent of material: Zn75%, Cu6%, Fe1.5%, Ag0.3%, Nd0.15%, Gd0.08%, surplus Mg.
5. the preparation method of pltine biodegradable angiocarpy bracket according to claim 1, which is characterized in that packet
Include following steps:
The blank tubing of required specification is made in S1, technique of the zinc-copper alloy material Jing Guo melting, extruding, drawing；S2 passes through
The rack body of reticular structure is made in pipe by laser cutting parameter；
S3, electrolytic polishing process handle bracket, remove small burr；
The bracket prepared is cleaned 30-40min using purified water, then is placed in hydrogenperoxide steam generator by S4, and setting temperature exists
2-4h is impregnated within the scope of 60-80 DEG C, purified water is rinsed well after taking-up；
S5 immerses in the good rapamycin drug solution of pre-coordination, and 10-20h is impregnated in heating；
S6, taking-up are placed in household freezer -80 DEG C, freeze 2-3h.
6. the preparation method of pltine biodegradable angiocarpy bracket according to claim 5, it is characterised in that: step
In rapid S4, the bracket prepared is cleaned into 35min using purified water, then be placed in hydrogenperoxide steam generator, temperature is set at 70 DEG C
3h is impregnated in range, purified water is rinsed well after taking-up.
7. the preparation method of pltine biodegradable angiocarpy bracket according to claim 5, it is characterised in that: step
In rapid S5, immerse in the good rapamycin drug solution of pre-coordination, 15h. is impregnated in heating
8. the preparation method of pltine biodegradable angiocarpy bracket according to claim 5, it is characterised in that: step
In rapid S6, taking-up is placed in household freezer -80 DEG C, freezes 2.5h.
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| CN201910160171.3A CN109847113A (en) | 2019-03-04 | 2019-03-04 | Pltine biodegradable angiocarpy bracket and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910160171.3A CN109847113A (en) | 2019-03-04 | 2019-03-04 | Pltine biodegradable angiocarpy bracket and preparation method thereof |
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| CN201910160171.3A Pending CN109847113A (en) | 2019-03-04 | 2019-03-04 | Pltine biodegradable angiocarpy bracket and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110421173A (en) * | 2019-09-17 | 2019-11-08 | 湖南华耀百奥医疗科技有限公司 | A kind of Zinc-base compounded material of medical degradable and the preparation method and application thereof |
| CN115054738A (en) * | 2022-08-18 | 2022-09-16 | 山东瑞安泰医疗技术有限公司 | Degradable zinc alloy nasal sinus support |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106467942A (en) * | 2015-08-19 | 2017-03-01 | 上海交通大学 | Biodegradable medical pltine and its production and use |
| CN106702212A (en) * | 2015-11-16 | 2017-05-24 | 上海交通大学 | Medical degradable Zn-Cu-X alloy material and preparation method thereof |
| CN106890356A (en) * | 2016-03-10 | 2017-06-27 | 山东瑞安泰医疗技术有限公司 | A kind of degradable zinc-containing alloy implantation material and preparation method and application |
| CN109097629A (en) * | 2018-09-21 | 2018-12-28 | 北京科技大学 | A kind of biodegradable Zn-Mo system kirsite and preparation method thereof |
| CN109128064A (en) * | 2018-09-21 | 2019-01-04 | 北京科技大学 | A kind of biodegradable Zn-Na system kirsite and preparation method thereof |
-
2019
- 2019-03-04 CN CN201910160171.3A patent/CN109847113A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106467942A (en) * | 2015-08-19 | 2017-03-01 | 上海交通大学 | Biodegradable medical pltine and its production and use |
| CN106702212A (en) * | 2015-11-16 | 2017-05-24 | 上海交通大学 | Medical degradable Zn-Cu-X alloy material and preparation method thereof |
| CN106890356A (en) * | 2016-03-10 | 2017-06-27 | 山东瑞安泰医疗技术有限公司 | A kind of degradable zinc-containing alloy implantation material and preparation method and application |
| CN106913916A (en) * | 2016-03-10 | 2017-07-04 | 山东瑞安泰医疗技术有限公司 | A kind of application of degradable zinc-containing alloy implantation material in intravascular stent is prepared |
| CN109097629A (en) * | 2018-09-21 | 2018-12-28 | 北京科技大学 | A kind of biodegradable Zn-Mo system kirsite and preparation method thereof |
| CN109128064A (en) * | 2018-09-21 | 2019-01-04 | 北京科技大学 | A kind of biodegradable Zn-Na system kirsite and preparation method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110421173A (en) * | 2019-09-17 | 2019-11-08 | 湖南华耀百奥医疗科技有限公司 | A kind of Zinc-base compounded material of medical degradable and the preparation method and application thereof |
| CN115054738A (en) * | 2022-08-18 | 2022-09-16 | 山东瑞安泰医疗技术有限公司 | Degradable zinc alloy nasal sinus support |
| CN115054738B (en) * | 2022-08-18 | 2022-10-28 | 山东瑞安泰医疗技术有限公司 | Degradable zinc alloy nasal sinus support |
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