CN105457105A - Novel developable magnesium alloy intravascular stent - Google Patents
Novel developable magnesium alloy intravascular stent Download PDFInfo
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- CN105457105A CN105457105A CN201510444398.2A CN201510444398A CN105457105A CN 105457105 A CN105457105 A CN 105457105A CN 201510444398 A CN201510444398 A CN 201510444398A CN 105457105 A CN105457105 A CN 105457105A
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Abstract
The invention relates to the field of medical apparatus and instruments, in particular to a novel developable magnesium alloy intravascular stent which is used for vascular intracavity stenosis treatment and is capable of being absorbed. The magnesium alloy intravascular stent has the structural design of being capable of achieving all-dimensional and multi-angle developing under the X-rays, assembly between a developing mark and the magnesium alloy intravascular stent is achieved in a macromolecule bonding mode, the developing mark is assembled into a developing ring which is reserved in advance through a macromolecule binding agent, galvanic corrosion between a developing material and a magnesium alloy base body is avoided, and visuality of the degradable magnesium alloy intravascular stent under X-ray developing equipment is achieved. By means of the novel developable magnesium alloy intravascular stent, the influence of adding of the developing mark on the profile of a stent system is effectively lowered, stent breakage caused by galvanic corrosion between the developing material and the magnesium alloy intravascular stent base body is avoided, thereby loss of the effective support effect of the stent on lesion blood vessels is avoided, the stent is accurately positioned, operability of stent implantation is improved, and no blind spot exists.
Description
Technical field
The present invention relates to medical instruments field, particularly relate to a kind of for Endovascular narrow treatment, the absorbable novel magnesium alloy blood vessel rack that develops.
Background technology
Along with the change of people's dietary habit, work, life stress constantly increase, and environmental pollution is day by day serious, and the crowd suffering from cardiovascular and cerebrovascular disease increases gradually.Coronary heart disease is one of disease that sickness rate is higher.At present, the mode of many employings implant frame treats the coronary heart disease such as coronary stenosis, support improves gradually in application process, develop, from bare metal stent (BMS) (postoperative stenosis rate 15 ~ 30%) originally, to the development & application (postoperative stenosis rate about 10%) of bracket for eluting medicament (DES), along with the continuous accumulation of clinical practice finds, inert metal rack platform is at a specified future date after the implantation exists the risk that advanced thrombus and restenosis occur.Therefore, the biodegradable stent that can be absorbed by the body gradually at effective military service after date is subject to extensive concern.
In recent years, magnesium-base metal (pure Magnesium and magnesium alloys) is because having low-down electrode potential, very active in fluid environment, easily corrodes, and then is safely absorbed metabolism in vivo, realize biodegradation.Magnesium alloy has preferably mechanical property, and magnesium elements is people's tumor growth, the necessary trace element of metabolism especially.These characteristics makes it be subject to the favor of people, and being expected to becomes degradable embedded material of new generation and obtain clinical practice.
Within nearly more than 10 years, come, the research both at home and abroad about degradable magnesium alloy vascular support emerges in an endless stream.2003, the people such as Heublein delivered first section of report using AE21 magnesium alloy as degradable angiocarpy bracket material on Heart magazine.The dissection and analysis result of 20 pieces of degradable magnesium alloy vascular supports after the arteria coronaria of 11 pigs is implanted into 10 days, 35 days and 56 days confirms: after the support force disappearance of support, blood vessel occurs that positivity reconstructs, and makes the vessel lumen internal diameter of the 56th day be greater than the 35th day; Owing to producing negative charge when magnesium alloy is degraded, in support, not easily form thrombosis.Subsequently, CarloDiMario reports the results of animal of WE43 magnesium alloy angiocarpy bracket, and 66 pieces of WE43 magnesium alloy blood vessel racks and 33 pieces of stainless steel stents are successfully implanted in 33 miniature pig coronary artery.Comparative study finds, implant after 4 weeks and 12 weeks, the minimum lumen diameter of magnesium alloy blood vessel rack group is obviously greater than stainless steel stent matched group, illustrates that the reconstructing blood vessel ability after implanting magnesium alloy blood vessel rack is better.
Large quantity research shows above, and magnesium alloy has biological safety as angiocarpy bracket material, and this just provides the strong foundation of biological safety aspect for the clinical practice of magnesium alloy angiocarpy bracket.But magnesium-base metal proportion is little, be not visible material under X-ray.
At present, the patent about magnesium alloy angiocarpy bracket focuses mostly in novel magnesium alloy development, Magnesiumalloy surface modifying and supporting structure optimization etc.
Such as, patent publication No. is that the Chinese invention patent of 102220529A discloses a kind of biodegradable intravascular stent Mg-Zn-Y-Nd magnesium alloy, and it has excellent corrosion resisting property and good plasticity.Patent publication No. is the preparation method that the Chinese invention patent of 103418035A discloses a kind of face coat of controllable magnesium alloy blood vessel rack degradation rate.These two patents are all lay particular emphasis on the problem solving the corrosion-resistant that magnesium alloy shows as vascular stent material, and the problem that magnesium alloy blood vessel rack is difficult to accurately location in implantation process rarely has report.
Magnesium alloy materials because of himself proportion low, not visible under X-ray, therefore, the accurate location of magnesium alloy blood vessel rack in implantation process and Follow-up After process becomes current another problem demanding prompt solution.Magnesium alloy blood vessel rack prepares developing mark, and realizing the location of support under X-ray is a kind of easy, easy and effective method.But magnesium-base metal material has very low electrode potential, when contacting with a large amount of metal material, namely it can corrode (galvanic corrosion) as anode.So, in order to not sacrifice the transporting of mounting system, do not shorten the military service phase of support, and realize accurate location in art and postoperative, need to arrange the distribution of developing mark on supporting structure properly, take effective method to realize the bonding of developing mark and magnesium alloy blood vessel rack.
Summary of the invention
The object of the invention is on the basis of the effectiveness in guarantee support under arms phase, a kind of novel magnesium alloy blood vessel rack that develops can be obtained, realize the visuality of degradable magnesium alloy vascular support under X-ray, solve magnesium alloy blood vessel rack and implant and problem not visible under X-ray in Follow-up After process.
Technical scheme of the present invention is:
A kind of novel magnesium alloy blood vessel rack that develops, this magnesium alloy blood vessel rack has structural design that is comprehensive under X-ray, multi-angle development, and realize the assembling between developing mark and magnesium alloy blood vessel rack by the mode that macromolecule bonds, by high polymer binder, developing mark is assembled in reserved developing ring, avoids, between developing materials and magnesium alloy substrate, galvanic corrosion occurs.
The described novel magnesium alloy blood vessel rack that develops, having structural design that is comprehensive under X-ray, multi-angle development is, the developing ring of pre-assembled developing mark is set in the outside of magnesium alloy blood vessel rack main body supporting structure, 2, every side developing ring, 4 developing ring cross-distribution are in support two ends.
The described novel magnesium alloy blood vessel rack that develops, the assembling that the mode bondd by macromolecule is realized between developing mark and magnesium alloy blood vessel rack is, select the binding agent of medical degradable macromolecular material as developing mark and magnesium alloy blood vessel rack of bad hydraulic permeability, developing mark size is less than the reserved developing ring size in support two ends, makes the bonded dose of developing mark wrapped up and support reserve developing ring and realizes Perfect Matchings.
The described novel magnesium alloy blood vessel rack that develops, high polymer binder is the degradable high polymer material of biological medical grade, comprising: one or more in polylactic acid, Poly-L-lactic acid, poly-racemic lactic acid, polycaprolactone, PTMC.
The described novel magnesium alloy blood vessel rack that develops, developing mark diameter is 0.2 ~ 0.5mm, and developing ring internal diameter is greater than developing mark diameter 0.05 ~ 0.15mm.
The described novel magnesium alloy blood vessel rack that develops, this magnesium alloy blood vessel rack realizes the visuality that stenter to implant and later stage follow up a case by regular visits to comprehensive, the multi-angle in process under X-ray, and under not sacrificing mounting system pressure and holding the prerequisite of size, effectively extend the military service phase of magnesium alloy blood vessel rack.
Design philosophy of the present invention is:
First, at prefabricated four developing rings in the outer two ends of magnesium alloy blood vessel rack main body supporting structure, four developing rings are cross-distribution.Then, adopt the method for physical bond to be mounted in prefabricated developing ring by developing mark thing, wherein binding agent is medical grade degradable high polymer material, and it should be the macromolecular material of bad hydraulic permeability.The preparation of this novel magnesium alloy blood vessel rack that develops comprises the distributing position of developing mark and the bonding of developing mark thing and magnesium alloy blood vessel rack: adopt two ends developing ring being placed in respectively rack body supporting construction, both by the position of four developing marks locating support more accurately, the interpolation because of developing mark can be avoided again to hold size to the pressure that mounting system is final and to have an impact; Medical grade degradable macromolecule binding agent is utilized developing mark thing and magnesium alloy blood vessel rack to be bondd, both achieve the assembling of developing mark thing on magnesium alloy blood vessel rack, again reduce the occurrence probability of developing mark thing and magnesium alloy substrate generation galvanic corrosion.This novel magnesium alloy blood vessel rack that develops has follows up a case by regular visits in process in implantation and later stage, the feature can accurately located under X-ray, the pressure that the interpolation of developing mark does not affect support final holds size, solve the galvanic corrosion caused because of the interpolation of developing mark thing, ensure that the length of service of magnesium alloy blood vessel rack.
Feature of the present invention and beneficial effect are:
1. the novel magnesium alloy blood vessel rack that develops of one provided by the invention, its developing mark is positioned at outside rack body supporting construction, support is with four developing marks, and cross-shaped distribution, this Novel bracket structure design with developing ring is key of the present invention.Under this kind of New-support can hold the prerequisite of diameter not sacrificing pressure, realizing the accurate location of comprehensive, the multi-angle of magnesium alloy blood vessel rack under X-ray, solving the problem that magnesium alloy blood vessel rack is not visible under X-ray.
2. the degradable blood vessel bracket that the present invention relates to is magnesium alloy blood vessel rack, in the prefabricated developing ring be fixed on by developing mark on magnesium alloy blood vessel rack by utilizing medical grade degradable high polymer material.Adopt the high polymer binder of bad hydraulic permeability, developing mark thing and magnesium alloy blood vessel rack twine are kept apart, avoid the destruction of the supporting structure caused because of galvanic corrosion.
3. in the present invention, the distribution of developing mark both can have been avoided rack body supporting construction to hold in process in pressure and cause damage, can reduce further again and cause because there is galvanic corrosion between developing mark and support twine the probability that supporting structure disintegrates, namely effectively ensure the military service phase of the magnesium alloy blood vessel rack that can develop.
Accompanying drawing explanation
Fig. 1. the novel magnesium alloy blood vessel rack structure chart that develops of the present invention.In figure, 1 magnesium alloy blood vessel rack; 2 developing rings.
Fig. 2. the development effect figure of magnesium alloy blood vessel rack in implantation process that develop of the present invention.
Detailed description of the invention
In a specific embodiment, the invention provides a kind of novel magnesium alloy blood vessel rack that develops.First design the structure at magnesium alloy blood vessel rack main body supporting structure two ends with prefabricated developing ring, developing ring quantity should be even number, evenly, cross-distribution at support two ends, each developing ring is positioned at the crest top of bracket end.Then carry out cut according to the structure of design, pickling is removed slag, polishing, surfacecti proteon process, then developing materials and stent strut is assembled by the method for physical bond, final drying, heat treatment.
The material of the degradable magnesium alloy vascular support that the present invention relates to comprises: pure Mg-based hydrogen storage, comprises the Magnesium Alloys such as Mg-Mn, Mg-Al-Zn, Mg-Al-Mn, Mg-Al-Si, Mg-Al-RE, Mg-Al-Ca, Mg-Al-Ca-RE, Mg-Al-Sr, Mg-Zn-Zr, Mg-Zn-Al, Mg-Zn-Al-Ca, Mg-Zn-Mn, Mg-RE-Zr, Mg-RE, Mg-RE-Mn, Mg-RE-Zn, Mg-Zn-Cu.The intravascular stent type that the present invention relates to comprises: coronary artery bracket, intracranial stent, periphery support and needs carry out the magnesium alloy implantable medical device of Imaging Study under X-ray.The distribution form of developing ring at support two ends reserved for developing mark thing of the present invention is staggered form, is uniformly distributed.Developing mark thing involved in the present invention is the metallics that the proportions such as metal tantalum (Ta), Aurum metallicum (Au), metal platinum (Pt), tungsten (W) are larger.This kind of material has under small size condition can the feature of clear development under X-ray.The medical grade hydrophobic polymer material that the present invention relates to, comprise in polylactic acid (PLA), Poly-L-lactic acid (PLLA), poly-racemic lactic acid (PDLLA), polycaprolactone (PCL), PTMC (PTMC) one or more.The solvent being used for dissolving high molecular polymer comprises: chloroform, dichloromethane, acetone, ethyl acetate, oxolane etc., and high molecular polymer is mixed with the polymer solution that concentration is 1 ~ 5wt% (being preferably 2 ~ 5wt%).
Following examples will be further described the present invention, but not thereby limiting the invention.
Embodiment 1:
(1) structural design of the novel magnesium alloy blood vessel rack that develops
Reserved four developing rings, 2, four developing rings 2 are cross-distribution at magnesium alloy blood vessel rack 1 two ends respectively through the magnesium alloy blood vessel rack 1 main body supporting structure two ends of structure optimization, see Fig. 1.Wherein, developing ring 2 is positioned at outside main body supporting structure, 4 cross-distribution, realize the accurate location near bracket edge, and no matter support is in any angle all can locate, it also avoid the profile that sacrifices mounting system because being arranged in main body supporting structure and pressure holds the destruction of process to coating simultaneously.
(2) support processing
According to the structure provided in (1), adopt the method for cut to process AZ31B magnesium alloy blood vessel rack, by pickling, polishing, dries up for subsequent use.Surfacecti proteon process is carried out to magnesium alloy bare bracket.Be more than the early-stage preparations of assembling developing mark.
(3) pressure holds experiment
The magnesium alloy blood vessel rack pressure being equipped with developing mark held on the sacculus matched with it, the diameter that pressure holds after-poppet system is 1.1mm, and pressure holds the distortion of after-poppet overall structure evenly, and the phenomenon that protective coating destroys does not occur.
Embodiment 2:
(1) developing mark assembling
First, compound concentration is the chloroform soln of the polycaprolactone (PCL) of 4wt%.Selected developing mark is circular design with reserved developing ring, the circumferential size 0.05mm less of reserved developing ring inner circle circumferential size of developing mark.Be assemblied in by the developing mark being enclosed with polycaprolactone in prefabricated developing ring, developing mark mates with developing ring well, dry.
(2) immersion in vitro experiment
By the novel magnesium alloy blood vessel rack that develops that processes according to 1.25cm
2the immersion ratio of/mL, to be soaked in PBS buffer solution 14 days, to have no obvious corrosion at the magnesium alloy substrate contacted with developing mark.
(3) development effect test experiments in body
The novel magnesium alloy blood vessel rack system of developing processed is implanted the iliac artery of laboratory animal pig, follow up a case by regular visits in angiographic procedure at stenter to implant and later stage, can accurate locating support position on the video screen of X-ray, see Fig. 2.Being the position of support two ends developing ring with the position of circle labelling in Fig. 2, the accurate location to implanting rear magnesium alloy blood vessel rack can being realized.Mounting system course of conveying is smooth and easy, does not occur the phenomenon that support developing ring tilts.
Embodiment result shows, the developing ring of two pre-installation developing marks is reserved respectively at magnesium alloy blood vessel rack main body two ends, four developing rings are cross-distribution (as shown in Figure 1), and this kind of distribution mode can guarantee that support all can be accurately positioned in any angle.By medical degradable high polymer binder, developing mark is assembled in reserved developing ring, be intended to avoid, between developing mark thing and magnesium alloy substrate, galvanic corrosion phenomena occurs by the iris action of high polymer binder, and realize the visuality of degradable magnesium alloy vascular support under X-ray developing apparatus.
In addition, the present invention adopts novel developing ring to be distributed in the method at rack body supporting construction two ends, and the impact of size (profile) is held in the interpolation effectively reducing developing mark on mounting system pressure.Thus, avoid and cause pole fracture because there is galvanic corrosion between developability material and magnesium alloy blood vessel rack pole matrix, thus cause support to lose the effect effectively supported lesion vessels; And can accurate locating support position, improve the operability of stenter to implant, there is not blind spot.Thus, solve problem not visible under X-ray in degradable magnesium alloy vascular stent implantation procedure, and developability material is easy and the problem of magnesium alloy substrate generation galvanic corrosion.
Claims (6)
1. the novel magnesium alloy blood vessel rack that develops, it is characterized in that, this magnesium alloy blood vessel rack has structural design that is comprehensive under X-ray, multi-angle development, and realize the assembling between developing mark and magnesium alloy blood vessel rack by the mode that macromolecule bonds, by high polymer binder, developing mark is assembled in reserved developing ring, avoids, between developing materials and magnesium alloy substrate, galvanic corrosion occurs.
2. according to the novel magnesium alloy blood vessel rack that develops according to claim 1, it is characterized in that, having structural design that is comprehensive under X-ray, multi-angle development is, the developing ring of pre-assembled developing mark is set in the outside of magnesium alloy blood vessel rack main body supporting structure, 2, every side developing ring, 4 developing ring cross-distribution are in support two ends.
3. according to the novel magnesium alloy blood vessel rack that develops according to claim 1, it is characterized in that, the assembling that the mode bondd by macromolecule is realized between developing mark and magnesium alloy blood vessel rack is, select the binding agent of medical degradable macromolecular material as developing mark and magnesium alloy blood vessel rack of bad hydraulic permeability, developing mark size is less than the reserved developing ring size in support two ends, makes the bonded dose of developing mark wrapped up and support reserve developing ring and realizes Perfect Matchings.
4. according to the novel magnesium alloy blood vessel rack that develops described in claim 1 or 3, it is characterized in that, high polymer binder is the degradable high polymer material of biological medical grade, comprising: one or more in polylactic acid, Poly-L-lactic acid, poly-racemic lactic acid, polycaprolactone, PTMC.
5. according to the novel magnesium alloy blood vessel rack that develops described in claim 1 or 3, it is characterized in that, developing mark diameter is 0.2 ~ 0.5mm, and developing ring internal diameter is greater than developing mark diameter 0.05 ~ 0.15mm.
6. according to the novel magnesium alloy blood vessel rack that develops according to claim 1, it is characterized in that, this magnesium alloy blood vessel rack realizes the visuality that stenter to implant and later stage follow up a case by regular visits to comprehensive, the multi-angle in process under X-ray, and under not sacrificing mounting system pressure and holding the prerequisite of size, effectively extend the military service phase of magnesium alloy blood vessel rack.
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| CN201510444398.2A CN105457105B (en) | 2015-07-24 | 2015-07-24 | One kind can develop magnesium alloy blood vessel rack |
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| CN201510444398.2A CN105457105B (en) | 2015-07-24 | 2015-07-24 | One kind can develop magnesium alloy blood vessel rack |
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| CN105457105B CN105457105B (en) | 2018-08-31 |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106937894A (en) * | 2017-03-16 | 2017-07-11 | 贵州医科大学附属医院 | Strengthen development mark, intravascular stent and the method for intravascular stent developing performance |
| CN107669380A (en) * | 2017-11-29 | 2018-02-09 | 成都创客之家科技有限公司 | A kind of drug eluting vascular support |
| CN107669381A (en) * | 2017-11-29 | 2018-02-09 | 成都创客之家科技有限公司 | A kind of medicament-release blood vessel stent |
| CN107693163A (en) * | 2017-11-29 | 2018-02-16 | 成都创客之家科技有限公司 | One kind can develop intravascular stent |
| CN107736958A (en) * | 2017-11-29 | 2018-02-27 | 成都创客之家科技有限公司 | A kind of titanium alloy medicament-release blood vessel stent |
| CN107736959A (en) * | 2017-11-29 | 2018-02-27 | 成都创客之家科技有限公司 | One kind, which can develop, carries medicine intravascular stent |
| CN107753149A (en) * | 2017-11-29 | 2018-03-06 | 成都创客之家科技有限公司 | A kind of intravascular stent with developing function |
| CN109893308A (en) * | 2017-12-06 | 2019-06-18 | 先健科技(深圳)有限公司 | Bracket and preparation method thereof |
| WO2024016928A1 (en) * | 2022-07-20 | 2024-01-25 | 聚辉医疗科技(深圳)有限公司 | Intravascular stent and preparation method therefor |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106937894A (en) * | 2017-03-16 | 2017-07-11 | 贵州医科大学附属医院 | Strengthen development mark, intravascular stent and the method for intravascular stent developing performance |
| CN107669380A (en) * | 2017-11-29 | 2018-02-09 | 成都创客之家科技有限公司 | A kind of drug eluting vascular support |
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| CN107736958A (en) * | 2017-11-29 | 2018-02-27 | 成都创客之家科技有限公司 | A kind of titanium alloy medicament-release blood vessel stent |
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| CN107753149A (en) * | 2017-11-29 | 2018-03-06 | 成都创客之家科技有限公司 | A kind of intravascular stent with developing function |
| CN109893308A (en) * | 2017-12-06 | 2019-06-18 | 先健科技(深圳)有限公司 | Bracket and preparation method thereof |
| WO2024016928A1 (en) * | 2022-07-20 | 2024-01-25 | 聚辉医疗科技(深圳)有限公司 | Intravascular stent and preparation method therefor |
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| CN105457105B (en) | 2018-08-31 |
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