CN115068703A - 一种生物可降解的显影材料的制备方法 - Google Patents
一种生物可降解的显影材料的制备方法 Download PDFInfo
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- 239000000463 material Substances 0.000 title claims abstract description 16
- 238000002360 preparation method Methods 0.000 title abstract description 5
- 229910000861 Mg alloy Inorganic materials 0.000 claims description 23
- 239000002245 particle Substances 0.000 claims description 18
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 11
- 239000004626 polylactic acid Substances 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 10
- 238000002156 mixing Methods 0.000 claims description 7
- KRHYYFGTRYWZRS-UHFFFAOYSA-N Fluorane Chemical compound F KRHYYFGTRYWZRS-UHFFFAOYSA-N 0.000 claims description 6
- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 0.000 claims description 6
- 239000002131 composite material Substances 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 4
- 239000011777 magnesium Substances 0.000 claims description 4
- 238000004140 cleaning Methods 0.000 claims description 3
- 238000003384 imaging method Methods 0.000 claims 1
- 229910052751 metal Inorganic materials 0.000 abstract description 13
- 239000002184 metal Substances 0.000 abstract description 13
- 229920000642 polymer Polymers 0.000 abstract description 7
- 229910045601 alloy Inorganic materials 0.000 abstract description 4
- 239000000956 alloy Substances 0.000 abstract description 4
- 239000011159 matrix material Substances 0.000 abstract description 4
- 238000012986 modification Methods 0.000 abstract description 3
- 230000004048 modification Effects 0.000 abstract description 3
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 6
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 4
- 229910052697 platinum Inorganic materials 0.000 description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- 208000007536 Thrombosis Diseases 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 238000005034 decoration Methods 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 229910052749 magnesium Inorganic materials 0.000 description 2
- 239000000155 melt Substances 0.000 description 2
- 229910000531 Co alloy Inorganic materials 0.000 description 1
- 241001391944 Commicarpus scandens Species 0.000 description 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 229910052742 iron Inorganic materials 0.000 description 1
- 239000003550 marker Substances 0.000 description 1
- 238000005498 polishing Methods 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 208000037803 restenosis Diseases 0.000 description 1
- 238000002791 soaking Methods 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 229910001256 stainless steel alloy Inorganic materials 0.000 description 1
- 238000001291 vacuum drying Methods 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/18—Materials at least partially X-ray or laser opaque
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L31/128—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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Abstract
本发明公开了一种生物可降解的显影材料的制备方法,通过对可降解金属/合金进行表面改性,改善其与聚合物基体材料的界面相容性,以便二者更好的粘结,利用熔融共混的方法将金属与聚合物进行混合,挤出所需材料,成本低,制备方便,利用本方法制得的复合材料,本身具有显影性,可以调控降解周期,改善支架力学性能。
Description
技术领域
本发明属于血管支架领域,具体涉及一种生物可降解的显影材料的制备方法。
背景技术
由于药物洗脱支架基体材料多为聚合物,显影方式多为压入铂球,显影性明显劣于金属支架,因此需要在不影响支架性能的前提下增加部分显影材料,以便后续对其植入位置及支架形态进行监控。
目前聚合物支架大多是通过在支架上设置圆孔状结构,通过挤压的方式将显影标记物压入显影孔内。由于支架壁厚较小,显影孔提供给显影点的周向支撑力不足,容易发生断裂或脱落,若在产品使用过程发生该问题,将会严重影响到患者的身体健康。此外,随着目前支架技术的发展,支架的尺寸、壁厚都有减小的趋势,上述问题发生的概率将会大大提高。
而金属支架的集体材料大多为不锈钢或是钴基合金,虽然显影性较好,但由于植入物不可降解,后续将引发血栓、再狭窄等问题,因此寻求一种新的可显影材料是目前亟待解决的问题。
发明内容
为解决上述问题,本发明公开了一种生物可降解的显影材料的制备方法,采用可降解金属改性后与聚合物形成复合材料,本身具有显影性,克服现有技术中存在的缺点,可以调控降解周期,改善支架力学性能。
为达到上述目的,本发明的技术方案如下:
一种生物可降解的显影材料的制备方法,包括以下步骤:
(1)将镁合金微粒浸入氟化物中,氟化物能够在镁合金微粒表面形成多孔结构;
(2)将步骤(1)后的镁合金微粒洗净干燥后与聚乳酸进行挤出共混,获得聚乳酸包覆镁合金的复合管。
作为优选,所述镁合金的成分质量数为96%Mg、3%Al和1%Zn。
作为优选,所述镁合金微粒的长度小于200微米。
作为优选,所述氟化物为48wt%的氢氟酸。
作为优选,所述聚乳酸的平均分子量为60000 g/mol。
作为优选,所述复合管里镁合金微粒含量为总质量的40-50%。
作为优选,步骤(2)将镁合金微粒与聚乳酸加入双螺杆挤出机熔融共混,熔融共混温度为160-200℃,时间为20-30min。
本发明的有益效果为:
1.得到的金属/聚乳酸复合材料本身具有显影性,摆脱了现有聚合物支架显影方式(多为压入铂球)的弊端,不会存在脱落、断裂的风险;
2.选用的金属为可降解金属,不会永久留在人体内,引发血栓等问题,同时金属的加入可以调控降解周期,改善支架力学性能;
3.选用的金属为可降解金属,如铁、镁等,获取途径广泛,且可加工,而目前聚合物支架多用的铂球由于尺寸较小,加工精度要求高,昂贵不易获取。
具体实施方式
下面结合具体实施方式,进一步阐明本发明,应理解下述具体实施方式仅用于说明本发明而不用于限制本发明的范围。
实施例
将镁合金(96%Mg,3%Al和1%Zn)进行切割、抛光成长度小于200微米的镁棒微粒,用丙酮及无水乙醇进行超声清洗后,置于真空干燥箱200℃干燥;将干燥后的镁合金微粒浸入48wt%的氢氟酸中,浸泡24-48h;用纯化水冲洗处理后的镁合金,干燥后制得表面处理后的镁合金。
将镁合金与聚乳酸加入双螺杆挤出机熔融共混,聚乳酸的平均分子量为60000 g/mol,合金含量为40-50%,熔融共混温度为160-200℃,时间为20-30min,得到共混产物。
需要说明的是,以上内容仅仅说明了本发明的技术思想,不能以此限定本发明的保护范围,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰均落入本发明权利要求书的保护范围之内。
Claims (7)
1.一种生物可降解的显影材料的制备方法,其特征在于:包括以下步骤:
(1)将镁合金微粒浸入氟化物中,氟化物能够在镁合金微粒表面形成多孔结构;
(2)将步骤(1)后的镁合金微粒洗净干燥后与聚乳酸进行挤出共混,获得聚乳酸包覆镁合金的复合管。
2.根据权利要求1所述的一种生物可降解的显影材料的制备方法,其特征在于:所述镁合金的成分质量数为96%Mg、3%Al和1%Zn。
3.根据权利要求2所述的一种生物可降解的显影材料的制备方法,其特征在于:所述镁合金微粒的长度小于200微米。
4.根据权利要求1所述的一种生物可降解的显影材料的制备方法,其特征在于:所述氟化物为48wt%的氢氟酸。
5.根据权利要求1所述的一种生物可降解的显影材料的制备方法,其特征在于:所述聚乳酸的平均分子量为60000 g/mol。
6.根据权利要求1所述的一种生物可降解的显影材料的制备方法,其特征在于:所述复合管里镁合金微粒含量为总质量的40-50%。
7.根据权利要求1所述的一种生物可降解的显影材料的制备方法,其特征在于:步骤(2)将镁合金微粒与聚乳酸加入双螺杆挤出机熔融共混,熔融共混温度为160-200℃,时间为20-30min。
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Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102895706A (zh) * | 2012-11-12 | 2013-01-30 | 重庆大学 | 一种生物医用耐蚀多孔复合材料及其制备方法 |
WO2014067202A1 (zh) * | 2012-10-30 | 2014-05-08 | 东南大学 | 生物可吸收医用人体腔道内支架及其制备方法 |
CN104689368A (zh) * | 2015-02-25 | 2015-06-10 | 上海交通大学 | 一种可降解的三维多孔镁基生物材料及其制备方法 |
CN105412996A (zh) * | 2015-12-04 | 2016-03-23 | 北京美中双和医疗器械股份有限公司 | 一种生物可降解支架及其制备方法 |
CN106063949A (zh) * | 2015-09-30 | 2016-11-02 | 圆容生物医药无锡有限公司 | 一种高强度可降解骨内固定复合材料 |
CN108659487A (zh) * | 2018-04-19 | 2018-10-16 | 东南大学 | 一种高性能镁/聚乳酸医用复合材料的增材制造方法 |
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- 2022-06-14 CN CN202210665808.6A patent/CN115068703A/zh active Pending
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2014067202A1 (zh) * | 2012-10-30 | 2014-05-08 | 东南大学 | 生物可吸收医用人体腔道内支架及其制备方法 |
CN102895706A (zh) * | 2012-11-12 | 2013-01-30 | 重庆大学 | 一种生物医用耐蚀多孔复合材料及其制备方法 |
CN104689368A (zh) * | 2015-02-25 | 2015-06-10 | 上海交通大学 | 一种可降解的三维多孔镁基生物材料及其制备方法 |
CN106063949A (zh) * | 2015-09-30 | 2016-11-02 | 圆容生物医药无锡有限公司 | 一种高强度可降解骨内固定复合材料 |
CN105412996A (zh) * | 2015-12-04 | 2016-03-23 | 北京美中双和医疗器械股份有限公司 | 一种生物可降解支架及其制备方法 |
CN108659487A (zh) * | 2018-04-19 | 2018-10-16 | 东南大学 | 一种高性能镁/聚乳酸医用复合材料的增材制造方法 |
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