CN112076352B - 医用液态金属热塑性功能复合材料及其制备方法与应用 - Google Patents
医用液态金属热塑性功能复合材料及其制备方法与应用 Download PDFInfo
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- CN112076352B CN112076352B CN202010875865.8A CN202010875865A CN112076352B CN 112076352 B CN112076352 B CN 112076352B CN 202010875865 A CN202010875865 A CN 202010875865A CN 112076352 B CN112076352 B CN 112076352B
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Classifications
-
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Abstract
本发明实施例提供一种医用液态金属热塑性功能复合材料及其制备方法与应用，所述复合材料包括以下质量百分比含量的组分：热塑性高分子基体材料70～90％、负离子填料0.1～10％和液态金属填料0.1～20％；所述负离子填料为可释放出负氧离子的材料。本发明实施例提供的医用液态金属热塑性功能复合材料与传统的石膏、聚氨酯高分子相比，具有可塑性好、舒适透气、硬化承重快、透射性好、质量轻、硬度适宜等特点，可加热到软化点温度后任意塑形以适应骨折部位形状；用该复合材料制备的夹板易拆卸且可重复使用，方便换药或夹板压力的调节，综合使用成本低，而且具有负离子释放等理疗保健功能，缩短康复时间，让患者有更好的康复体验。
Description
技术领域
本发明涉及医疗用品技术领域，尤其涉及一种医用液态金属热塑性功能复合材料及其制备方法与应用。
背景技术
全球每年在生产、生活中有数以亿计的骨折事故发生，外固定材料用于骨折的术后固定和康复治疗，其市场需求日益增加。
目前临床应用最广泛的石膏和热塑性夹板由于自身的缺陷已越来越不适应骨外固定的需求。传统石膏操作复杂，硬化承重时间长，硬度欠佳、质量大，舒适感、服帖性、透气性差、不可重复使用；不能穿透X射线，不方便患者骨折愈合情况的复查；不能与水结合，影响医生换药、创面处理。聚氨酯高分子夹板不可重复使用、塑形差、硬度高、拆卸困难，不利于骨折部位的血运；生物降解性差，多数聚氨酯材料的降解产物有毒性，容易污染环境，故其广泛应用也受到一定的限制。
发明内容
本发明实施例提供一种医用液态金属热塑性功能复合材料及其制备方法与应用，用以解决现有技术中外固定材料不可重复使用、硬化承重时间长、塑形差或拆卸困难的缺陷，达到满足骨外固定需求和提升患者舒适度等效果。
本发明实施例提供一种医用液态金属热塑性功能复合材料，包括以下质量百分比含量的组分：热塑性高分子基体材料70～90％、负离子填料0.1～10％和液态金属填料0.1～20％；所述负离子填料为可释放出负氧离子的材料。
本发明实施例以热塑性高分子基体材料为主体材料，其具有质量轻、可重复使用、透射性好、可降解、绿色环保等优点；同时，该热塑性高分子基体材料在加热到软化点时能够实现可逆软化塑形，具有良好的可塑性和快速的硬化承重性能，故本发明实施例提供的复合材料可广泛应用于骨科领域的固定。
本发明实施例中所述热塑性高分子基体材料为聚己内酯(PCL)、反式聚异戊二烯(TPI)、聚乳酸(PLA)、聚左旋乳酸(PLLA)、聚右旋乳酸(PDLA)、聚消旋乳酸(PDLLA)、聚乙交酯(PGA)、聚丁二酸丁二醇酯(PBS)、聚丁二酸-对苯二甲酸-丁二醇酯(PBAT)、聚丁二酸-己二酸-丁二醇酯(PBSA)、聚羟基脂肪酸酯(PHA)、聚3-羟基丁酸酯(PHB)、羟基乙酸-羟基戊酸共聚酯(PHBV)、3-羟基丁酸酯和3-羟基己酸酯的共聚物(PHBH)、乙烯/醋酸乙烯酯共聚物(EVA)、聚乙烯醇(PVA)、聚酰胺树脂(PA)、聚氨酯树脂(PU)、聚对苯二甲酸乙二醇酯(PET)、乙二醇改性-聚对苯二甲酸乙二醇酯(PETG)、聚芳酯(PAR)、聚对苯二甲酸丁二酯(PBT)、聚丙烯酸乙脂(PEA)、聚酯树脂(PES)、聚乙二醇(PEG)、聚苯胺、聚碳酸酯(PC)、二氧化碳共聚物(PPC)、可塑性淀粉材料(PSM)、纤维素、壳聚糖中的一种或多种复合改性材料。
优选地，所述热塑性高分子基体材料为颗粒状，可通过一种或多种聚合物进行混炼、挤出、造粒制得。
本发明实施例还在热塑性高分子基体材料中加入了可释放出负氧离子的负离子填料，使得复合材料不仅满足了骨折部位的支撑和固定，还可以通过释放出的负氧离子的疗养保健作用，加快患者康复进程。更为出乎意料的是，加入负离子填料的同时加入液态金属填料，可以显著增强负氧离子释放量，使得复合材料能够释放更多的负氧离子，而且加入液态金属填料可以改善复合材料的力学性能，能够显著提升复合材料的拉伸、弯曲及冲击强度。
根据本发明实施例提供的医用液态金属热塑性功能复合材料，所述负离子填料为电气石、蛋白石、六环石、奇冰石、海底矿物、稀土盐及氧化物中的一种或多种。
其中，电气石为含硼的铝、钠、铁、镁、锂的环状结构硅酸盐矿物；蛋白石为含水的非晶质二氧化硅，少量三氧化二铝、三氧化二铁等；六环石为氧化镁、二氧化硅、氧化钙及变价铁的复杂化合物；奇冰石含镁、铝、硼、少量铝的硅酸盐；海底矿物为硅酸盐和铝、铁等氧化物为主要成分的无机系填料。
优选地，所述负离子填料为电气石，其有益效果在于电气石兼具热电、压电及自发电极效应，能产生电极、形成静电场、产生负离子、发射远红外线、杀菌、净化空气、表面活性和吸附等优良性能，能够促进人体呼吸保健和血液循环,增强人体抵抗力，提高人体自愈能力和调节人体离子平衡等功效。
本发明实施例中所述液态金属填料为单质金属、二元合金、三元合金、四元合金、多元合金中的一种或多种，所述单质金属选自锡、铟、锌、铋、铝；所述二元合金选自锡铋、锡铟、锡锌、锡铝、铟铋、铟锌、铟铝、锌铋、锌铝、铋铝、锡银、锡铜二元合金；所述三元合金选自铋铟锡、铋铟锌、铋铟铝、铋锡锌、铋锡铝、铋锌铝、铟锡锌、铟锡铝、铟锌铝、锡锌铝、锡铋银、锡铋铜、锡银铜三元合金；所述四元合金选自铋铟锡锌、铋铟锡铝、铋铟锌铝、铋锡锌铝、铟锡锌铝、锡铋铜银四元合金；所述多元合金是由锡、铟、锌、铋、铝、银、铜、镍中的一种或多种与所述二元合金、三元合金、四元合金中的一种配制而成的中低温多元合金。
根据本发明实施例提供的医用液态金属热塑性功能复合材料，所述液态金属填料优选为由锡、银、铟、铋、锡银铜、铋铟锡、锡铟和锡锌铝的微纳米粉末按质量比(70-80):(1-5):(3-7):(8-12):(1-3):(1-2):(2～8):(5～10)组成的混合物。此时，能够显著提升液态金属填料的抗氧化性和导热性，同时能够与其它填料协同提升复合材料的力学、热学等性能，降低复合材料的成型收缩率和熔融流动性，使得制成夹板后具有更优异的塑形效果和固定强度。
进一步优选地，所述负离子填料的粒径为1nm～150μm，所述液态金属填料的粒径为1～80μm，该粒径范围的填料能够获得更好的负离子释放效果，同时能够提升复合材料的拉伸、弯曲及冲击强度。
根据本发明实施例提供的医用液态金属热塑性功能复合材料，所述复合材料还包括远红外填料、抗菌填料和磁性填料中的一种或多种；
所述远红外填料为20～25℃下能辐射出3～15μm波长的远红外线的微纳米粉。
本发明实施例中所述远红外填料可以为Al2O3、ZrO2、MgO、TiO2、ZrC、SiC、B4C、TaC、TiB2、ZrB2、CrB2、TiSi2、MoSi2、WSi2、Si3N4、TiN中的一种或多种。加入远红外填料可使复合材料发射远红外线，其发射的远红外线最容易被人体吸收，使人体各部位产生生理热效应，促进人体血液循环，有利于伤口愈合，消除炎症，削减疼痛。优选地，所述远红外填料为远红外陶瓷粉。
本发明实施例中所述抗菌填料为将银、铜、锌等金属(或其离子)固定在氟石、硅胶等多孔材料表面制成的抗菌剂，或为氧化锌、氧化铜、磷酸二氢铵、碳酸锂等无机抗菌剂。优选地，所述抗菌填料为银离子类抗菌剂，其载体为磷酸锆、沸石、陶瓷或活性炭等。
本发明实施例中所述磁性填料为铁粉、四氧化三铁粉、铁硅粉、镍粉、钴粉中的一种或多种，优选为四氧化三铁粉，所述磁性填料粒径为1nm～150μm。
在本发明一个优选实施例中，所述医用液态金属热塑性功能复合材料包括以下质量百分比含量的组分：热塑性高分子基体材料70～90％、负离子填料0.1～10％、液态金属填料0.1～20％、远红外填料0.1～10％和抗菌填料0.1～5％；所述远红外填料为远红外陶瓷粉，所述抗菌填料为银离子类抗菌剂。
进一步地，所述远红外填料和所述抗菌填料的粒径为1nm～80μm。
一般骨折术后前期由于组织的损伤需要持续的冷敷消肿，传统夹板太厚且传热性差，冷敷效果较差；同时，由于传统夹板的透气性较差且无抗菌功能，容易导致细菌感染而溃烂，给患者带来痛苦且影响骨折愈合的速度；在后期，夹板的松紧程度直接影响血液循环及后续功能锻炼，此时需要及时调整夹板的松紧度或换药处理，传统夹板为刚性材料拆卸困难且不可重复使用，需用工具强制拆除后更换新的夹板，操作繁琐且增加了治疗的成本。而使用本发明实施例提供的医用液态金属热塑性功能复合材料，不仅满足了骨折部位的支撑和固定，同时又满足了冷、热、磁等多功能理疗的需求，提升了患者的舒适度和加快康复进程。
进一步优选地，在上述实施例基础上，所述负离子填料为电气石，粒径为1nm～150μm；所述液态金属填料为由锡、银、铟、铋、锡银铜、铋铟锡、锡铟和锡锌铝的微纳米粉末按质量比(70-80):(1-5):(3-7):(8-12):(1-3):(1-2):(2～8):(5～10)组成的混合物，粒径为1～80μm。
在上述实施例基础上，可进一步通过所述热塑性高分子基体材料组分及配比的设计调控复合材料的力学、热学、电学、光学等性能，以满足骨科外固定的应用需求。
具体地，在上述实施例基础上，所述热塑性高分子基体材料为聚己内酯，通过与液态金属填料的复合制备出复合材料，具有质量轻、可重复使用、透射性好、可降解、绿色环保等优点；同时，复合材料在加热到软化点时能够实现可逆软化塑形，具有良好的可塑性和快速的硬化承重性能。
或者，在上述实施例基础上，所述热塑性高分子基体材料为聚己内酯和聚乳酸按质量比4:1组成的混合物，此时能够显著提升复合材料的力学性能。
或者，在上述实施例基础上，所述热塑性高分子基体材料为聚己内酯、聚乳酸、聚乙二醇和聚羟基脂肪酸酯按质量比7:1:1:1组成的混合物，此时能够显著提升复合材料的力学性能。
本发明实施例所述医用液态金属热塑性功能复合材料可加工成片材、线材或异形。所谓异形指非规则形状。
本发明实施例还提供上述医用液态金属热塑性功能复合材料的制备方法，包括：
按照配比将各组分混合均匀，进行熔融混炼，再将所得复合材料熔体进行成型；成型方法为辊压或层压成型、注射成型、挤出成型。
其中，所述熔融混炼的方式包括捏合、密练和/或开练。
具体的成型方法可根据不同的应用需求进行选择：
若将所得复合材料熔体辊压或层压成型，可压制成不同厚度的片材夹板，所述辊压或层压方式均带有加热功能；
若将所得复合材料熔体采用注射成型，通过模具的设计，可一次成型出外形复杂、尺寸精确的医用异形夹板，所用的注射模具可根据需要定制；
若将所得复合材料熔体加入到挤出机中，在挤压系统的作用下，将熔体挤出为线材或片材，其中线材可3D打印出满足使用要求的定制化夹板，所述线材或片材的制备可通过挤头模具的设计实现。
本发明实施例还提供上述医用液态金属热塑性功能复合材料在制备骨科用外固定材料中的应用。
本发明实施例提供的医用液态金属热塑性功能复合材料与传统的石膏、聚氨酯高分子相比，具有可塑性好、舒适透气、硬化承重快、透射性好、质量轻、硬度适宜等特点，可加热到软化点温度后任意塑形以适应骨折部位形状，而且该复合材料具有良好的生物降解性，材料废弃降解产物无毒无害，绿色环保；用该复合材料制备的夹板易拆卸且可重复使用，方便换药或夹板压力的调节，综合使用成本低，而且具有负离子释放等理疗保健功能，缩短了康复时间，让患者有更好的康复体验。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚，下面对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
以下实施例中各试剂原料均可市售购得。
实施例1
本实施例提供一种医用液态金属热塑性功能复合材料，由以下质量百分比的组分组成：80％聚己内酯(PCL)，8％液态金属填料，5％负离子填料，5％远红外填料，1％抗菌填料和1％磁性填料。
其中，负离子填料为电气石粉，粒径为10微米；远红外填料为远红外陶瓷粉，粒径为1微米；抗菌填料为银离子抗菌填料，粒径为25微米；磁性填料为四氧化三铁粉，粒径为45微米。
液态金属填料由锡、银、铟、铋、锡银铜、铋铟锡、锡铟、锡锌铝的微纳米粉末按质量比70:1:3:8:1:2:8:10充分混合而成，粒径为10微米。
本实施例还提供上述医用液态金属热塑性功能复合材料的制备方法，步骤如下：
(1)按照配比称取热塑性高分子基体材料、负离子填料、远红外填料、液态金属填料、抗菌填料和磁性填料，将其充分搅拌混合，搅拌方式为机械搅拌；
(2)将步骤(1)中充分混合的物料进行熔融混炼，得到混合均匀的医用液态金属热塑性功能复合材料熔体，熔融混炼的方式为捏合；
(3)将步骤(2)中复合材料熔体辊压或层压成型，压制成不同厚度的片材夹板，所述辊压或层压方式均带有加热功能。
将上述制备方法制备出的片材夹板应用于骨科领域的固定。
实施例2
本实施例提供一种医用液态金属热塑性功能复合材料，由以下质量百分比的组分组成：80％热塑性高分子基体材料，8％液态金属填料，5％负离子填料，5％远红外填料和2％抗菌填料。
其中，热塑性高分子基体材料由聚己内酯和聚乳酸按4:1的质量比充分混合而成；
液态金属填料由锡、银、铟、铋、锡银铜、铋铟锡、锡铟、锡锌铝的微纳米粉末按质量比70:1:3:8:1:2:8:10充分混合而成，粒径为10微米；
负离子填料为电气石粉，粒径为10微米；远红外填料为远红外陶瓷粉，粒径为1微米；抗菌填料为银离子抗菌填料，粒径为25微米。
本实施例还提供上述医用液态金属热塑性功能复合材料的制备方法，步骤如下：
(1)按照配比称取热塑性高分子基体材料、负离子填料、远红外填料、液态金属填料和抗菌填料，将其充分搅拌混合，搅拌方式为机械搅拌；
(2)将步骤(1)中充分混合的物料进行熔融混炼，得到混合均匀的医用液态金属热塑性功能复合材料熔体，熔融混炼的方式为密练；
(3)将步骤(2)中复合材料熔体采用注射成型，通过模具的设计，可一次成型出外形复杂、尺寸精确的医用异形夹板，其中注射模具可根据需要定制。
将上述制备方法制备出的医用异形夹板应用于骨科领域的固定。
实施例3
本实施例提供一种医用液态金属热塑性功能复合材料，由以下质量百分比的组分组成：80％热塑性高分子基体材料，8％液态金属填料，5％负离子填料，5％远红外填料和2％抗菌填料。
其中，热塑性高分子基体材料由聚己内酯(PCL)、聚乳酸(PLA)、聚乙二醇(PEG)和聚羟基脂肪酸酯(PHA)按7:1:1:1的质量比充分混合而成；
液态金属填料由锡、银、铟、铋、锡银铜、铋铟锡、锡铟、锡锌铝的微纳米粉末按质量比70:1:3:8:1:2:8:10充分混合而成，粒径为10微米；
负离子填料为电气石粉，粒径为10微米；远红外填料为远红外陶瓷粉，粒径为1微米；抗菌填料为银离子抗菌填料，粒径为25微米。
本实施例还提供上述医用液态金属热塑性功能复合材料的制备方法，步骤如下：
(1)按照配比称取热塑性高分子基体材料、负离子填料、远红外填料、液态金属填料和抗菌填料，将其充分搅拌混合，搅拌方式为手动搅拌和机械搅拌；
(2)将步骤(1)中充分混合的物料进行熔融混炼，得到混合均匀的医用液态金属热塑性功能复合材料熔体，熔融混炼的方式为密练和开练；
(3)将步骤(2)中复合材料熔体加入到挤出机中，在挤压系统的作用下，将熔体挤出为线材或片材，其中线材可3D打印出满足使用要求的定制化夹板，其中线材或片材的制备可通过挤头模具的设计实现。
实施例4
本实施例提供一种医用液态金属热塑性功能复合材料，由以下质量百分比的组分组成：80％聚己内酯，13％液态金属填料和7％负离子填料。
其中，负离子填料为电气石粉，粒径为10微米；
液态金属填料由锡、银、铟、铋、锡银铜、铋铟锡、锡铟、锡锌铝的微纳米粉末按质量比70:1:3:8:1:2:8:10充分混合而成，粒径为10微米。
实施例5
本实施例提供一种医用液态金属热塑性功能复合材料，由以下质量百分比的组分组成：80％聚己内酯，13％液态金属填料和7％负离子填料。
其中，负离子填料为电气石粉，粒径为10微米；
液态金属填料为铋铟锡三元合金，粒径为10微米。
对比例1
本对比例提供一种复合材料，由以下质量百分比的组分组成：93％聚己内酯和7％负离子填料。
其中，负离子填料为电气石粉，粒径为10微米。
性能测试
实验对象：实施例1-5和对比例1的复合材料；
其中硬化承重时间的测试方法为复合材料加热软化后置于室温(25℃)，材料由软变硬所需时间；
负离子释放量采用《JC/T 1016-2006材料负离子发生量的测试方法》进行测试。测试结果见表1。
表1各复合材料的性能测试结果
从表1可以看出，本发明实施例提供的医用液态金属热塑性功能复合材料具有可塑性好、舒适透气、硬化承重快、透射性好、质量轻、硬度适宜等特点，可加热到软化点温度后任意塑形以适应骨折部位形状，而且该复合材料具有良好的生物降解性，材料废弃降解产物无毒无害，绿色环保；用该复合材料制备的夹板易拆卸且可重复使用，方便换药或夹板压力的调节，综合使用成本低，而且具有负离子释放等理疗保健功能，缩短了康复时间，让患者有更好的康复体验。
最后应说明的是：以上实施例仅用以说明本发明的技术方案，而非对其限制；尽管参照前述实施例对本发明进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本发明各实施例技术方案的精神和范围。
Claims (10)
1.一种医用液态金属热塑性功能复合材料，其特征在于，包括以下质量百分比含量的组分：热塑性高分子基体材料70～90％、负离子填料0.1～10％和液态金属填料0.1～20％；
所述负离子填料为可释放出负氧离子的材料；
所述液态金属填料为由锡、银、铟、铋、锡银铜、铋铟锡、锡铟和锡锌铝的微纳米粉末按质量比(70-80):(1-5):(3-7):(8-12):(1-3):(1-2):(2～8):(5～10)组成的混合物。
2.根据权利要求1所述的医用液态金属热塑性功能复合材料，其特征在于，所述负离子填料为电气石、蛋白石、六环石、奇冰石、海底矿物、稀土盐及稀土氧化物中的一种或多种。
3.根据权利要求2所述的医用液态金属热塑性功能复合材料，其特征在于，所述负离子填料为电气石。
4.根据权利要求1所述的医用液态金属热塑性功能复合材料，其特征在于，所述负离子填料的粒径为1nm～150μm，所述液态金属填料的粒径为1～80μm。
5.根据权利要求1～4任一项所述的医用液态金属热塑性功能复合材料，其特征在于，还包括远红外填料、抗菌填料和磁性填料中的一种或多种；
所述远红外填料为20～25℃下能辐射出3～15μm波长的远红外线的微纳米粉。
6.根据权利要求5所述的医用液态金属热塑性功能复合材料，其特征在于，所述医用液态金属热塑性功能复合材料包括以下质量百分比含量的组分：热塑性高分子基体材料70～90％、负离子填料0.1～10％、液态金属填料0.1～20％、远红外填料0.1～10％和抗菌填料0.1～5％；
所述远红外填料为远红外陶瓷粉，所述抗菌填料为银离子类抗菌剂；
和/或，所述远红外填料和所述抗菌填料的粒径为1nm～80μm。
7.根据权利要求6所述的医用液态金属热塑性功能复合材料，其特征在于，所述热塑性高分子基体材料为聚己内酯，
或为聚己内酯和聚乳酸按质量比4:1组成的混合物，
或为聚己内酯、聚乳酸、聚乙二醇和聚羟基脂肪酸酯按质量比7:1:1:1组成的混合物。
8.根据权利要求1～4任一项所述的医用液态金属热塑性功能复合材料，其特征在于，所述医用液态金属热塑性功能复合材料加工成片材、线材或异形。
9.权利要求1～8任一项所述的医用液态金属热塑性功能复合材料的制备方法，其特征在于，包括：
按照配比将各组分混合均匀，进行熔融混炼，再将所得复合材料熔体进行成型；
成型方法为辊压或层压成型、注射成型、挤出成型。
10.权利要求1～8任一项所述的医用液态金属热塑性功能复合材料在制备骨科用外固定材料中的应用。
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| CN114957950A (zh) * | 2022-07-07 | 2022-08-30 | 王丽华 | 一种应用于液体中具有释放负离子的环保材料 |
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| CN104804386A (zh) * | 2014-01-26 | 2015-07-29 | 北京赛特瑞科技发展有限公司 | 一种功能定位板、制备方法及其用途 |
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| CN104804386A (zh) * | 2014-01-26 | 2015-07-29 | 北京赛特瑞科技发展有限公司 | 一种功能定位板、制备方法及其用途 |
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