CN110802825B - 一种具有超声能力的医用导管的制备方法及其产品 - Google Patents
一种具有超声能力的医用导管的制备方法及其产品 Download PDFInfo
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Abstract
本发明公开了一种具有超声能力的医用导管的制备方法,步骤为:1)将聚醚多元醇、聚醚多元醇、三乙醇胺、去离子水、1,1,1‑三羟甲基丙烷、1,4‑丁二醇及硅油混合搅拌,形成A料;2)将异氰酸酯预聚体MDI作为B料;3)将B料迅速倒入A料中,搅拌后将物料倒入模具中自由发泡,取出泡沫,制得硬质聚氨酯泡沫RPUF,常温熟化之后进行切样;4)将步骤3)中的切样与热塑性聚氨酯TPU粒料共混,所述的TPU/RPUF的比例为2.3~4,挤出,冷却,得到线材。采用该制备方法得到的医用导管具有良好的超声成像的效果,与现有的医用导管的力学性能相比,能够满足医疗行业的应用要求。
Description
技术领域
本发明属于生物医用材料领域,涉及一种具有超声能力的医用导管的制备方法及其产品。
背景技术
随着医学、材料学、生物学和化学等学科的发展,医用高分子材料在生物医学领域得到广泛应用。首先高分子材料具有优良的力学性能和化学稳定性,非常适合在医疗上使用。其次高分子材料来源广泛,价格低廉,适合制成一次性医疗用品,避免了传统材料制品因价格昂贵而不得不多次使用导致的消毒和交叉感染的问题。
聚氨酯(PU)很早就应用在生产医用导管的材料上,它化学性质稳定,并且具有低毒性、无致畸变作用等良好的生物相容性。同时聚氨酯材料物理性能良好、产品易加工、产品质量优良,因此在医疗领域应用广泛并且可以保持人体植入的长期稳定性。同聚四氟乙烯(PTFE)、聚氯乙烯(PVC)、聚乙烯(PE)等材料相比,由聚氨酯制造的导管具有足够的刚性,有利于进入体内。PU能够热塑挤出成型,易于加工成各种规格的管材。
医用导管是连通人体内外的管腔制品总称,主要用在排液、药物递送、采血、血液传输与透析等方面有重要的应用。常用的导管有腹腔透析管、导尿管、中心静脉导管、留置针外周导管、经皮冠状动脉腔内血管成形术(PTCA)球囊扩张导管等。医用导管在医疗上已经成为不可缺少的工具,当医用导管介入人体进行操作时,缺乏经验的医生在进行插管时很难做到精准定位,同时,在插管过程中多次不能精确定位,给病人带来极大的痛苦,有时还会延误治疗的时机。为此研发出一种具有超声成像能力的医用导管,利用超声成像技术实时监测导管插入的部位,做到精确无误导入尤为重要。
发明内容
有鉴于此,本发明提供一种一种具有超声能力的医用导管的制备方法及其产品。
本发明具体提供了如下的技术方案:
1、一种具有超声能力的医用导管的制备方法,步骤为:
1)将聚醚多元醇、聚醚多元醇、三乙醇胺、去离子水、1,1,1-三羟甲基丙烷、1,4-丁二醇及硅油混合搅拌,形成A料;
2)将异氰酸酯预聚体MDI作为B料;
3)将B料迅速倒入A料中,搅拌后将物料倒入模具中自由发泡,取出泡沫,制得硬质聚氨酯泡沫RPUF,常温熟化之后进行切样;
4)将步骤(3)中的切样与热塑性聚氨酯TPU粒料共混,所述的TPU/RPUF的比例为2.3~4,挤出,冷却,得到线材样品;
5)将步骤4)得到的线材样品进行造粒,注塑成型。
进一步,步骤1)按质量份数计,聚醚多元醇为95~105份、所述的聚醚多元醇为20~40份、所述的三乙醇胺为4.5~5.5份、所述的去离子水为0.5~1.0份、所述的1,1,1-三羟甲基丙烷为1.0~1.5份、所述的1,4-丁二醇为1.8~2.5份,所述的硅油为2.0~2.5份。
进一步,步骤1)所述的混合搅拌的转速为290~310r/min,搅拌时间30~35s。
进一步,步骤2)按质量份数计,所述的异氰酸酯预聚体MDI为165~170份。
进一步,步骤3)所述的搅拌速度为290~310r/min,搅拌时间35~40s,发泡时间5~7min。
进一步,步骤4)所述的TPU/RPUF的比例为80/20和70/30。
进一步,步骤4)所述的挤出为双螺杆挤出机挤出,螺杆转速为100~110r/min,挤出温度为180℃~200℃;
进一步,步骤1)所述的聚醚多元醇的型号为303,聚醚多元醇的型号为390。
2、根据上述制备方法制备得到的一种具有超声能力的医用导管,其拉伸强度为9.0~18.4MPa,冲击强度为6.7~26.4KJ/m2,断裂伸长率71.9~495.9,弹性模量为65.5~109.9MPa。
本发明的有益效果在于:本发明通过对聚氨酯泡沫配方的调配,通过双螺杆挤出工艺将聚氨酯泡沫(RPUF)与热塑性聚氨酯(TPU)粒料共混,与纯的TPU导管材料相比,得到的导管材料具有良好的超声成像效果,可以得出TPU/RPUF为2.3~4.0时,超声成像的效果尤为明显。本发明制得具有超声成像能力的医用导管材料,冲击强度在6.7KJ/m2以上,拉伸强度在9.0MPa以上,断裂伸长率在71.9%以上,弹性模量在65.5~109.9MPa之间。同时,还具有良好的超声成像的效果,通过对力学性能进行表征,与现有的医用导管的力学性能相比,能够满足医疗行业的应用要求,有较好的应用前景。本发明的具有超声成像能力的医用导管,所用的原料价格低廉,制备工艺简单,适用于大规模生产。
附图说明
为了使本发明的目的、技术方案和有益效果更加清楚,本发明提供如下附图:
图1为导管材料超声检测的效果图。
图2为导管材料的力学性能对比图。
具体实施方式
下面结合附图,对本发明的优选实施例进行详细的描述。
实施例1
(1)按质量份准确称取聚醚多元醇(303)100份、聚醚多元醇(390)25份、三乙醇胺4.5份、去离子水1.0份、1,1,1-三羟甲基丙烷1.2份、1,4-丁二醇1.8份及硅油2.2份混合以转速为300r/min搅拌30s,静置,形成组合料(A料);
(2)准确称取异氰酸酯预聚体MDI 167份,为B料;
(3)将B料迅速倒入A料中,同时以300r/min搅拌35s后,立即将变白的物料倒入模具中自由发泡,大约6min后取出泡沫,制得硬质聚氨酯泡沫(RPUF),常温熟化之后进行切样;
(4)将步骤(3)中的切样与TPU粒料共混,TPU/RPUF的比例为100/0,送入双螺杆挤出机进行挤出,螺杆转速为100r/min,挤出温度为195℃,经冷却后得到线材样品,并对其超声成像的效果进行检测;
(5)将得到的样品进行造粒,通过注塑机注塑,注塑温度为195℃并对其力学性能进行表征。
制得的具有超声成像能力的医用导管的性能测试如图1(a)和图2。
图2(a)拉伸强度,(b)冲击强度,(c)弹性模量,(d)断裂伸长率
从图1中的(a)可以看出:TPU/RPUF=100/0的超声成像的效果最不明显,完全看不到导管材料插入的位置。
从图2中看出,当TPU/RPUF为100/0时,拉伸强度、冲击强度、断裂伸长率最大,分别为18.4MPa、26.4KJ/m2、495.9%;弹性模量最小,为65.5MPa。与文献《气管导管力学性能实验研究》中国产气管导管的力学性能相比,其拉伸强度、断裂伸长率比文献中(拉伸强度为6.12MPa、断裂伸长率为41.74%)的大,而弹性模量比文献中(弹性模量为627.56MPa)的小。作为医用导管,拉伸强度和断裂伸长率大一点好,而弹性模量小一点较好,本实施例的力学性能能满足医用导管的使用要求。
实施例2
(1)按质量份准确称取聚醚多元醇(303)100份、聚醚多元醇(390)40份、三乙醇胺5.0份、去离子水0.5份、1,1,1-三羟甲基丙烷1.5份、1,4-丁二醇2.5份及硅油2.0份混合以转速为300r/min搅拌30s,静置,形成组合料(A料);
(2)准确称取异氰酸酯预聚体MDI 165份,为B料;
(3)将B料迅速倒入A料中,同时以300r/min搅拌35s后,立即将变白的物料倒入模具中自由发泡,大约6min后取出泡沫,制得硬质聚氨酯泡沫(RPUF),常温熟化之后进行切样;
(4)将步骤(3)中的切样与TPU粒料共混,TPU/RPUF的比例为90/10,送入双螺杆挤出机进行挤出,螺杆转速为100r/min,挤出温度为190℃,经冷却后得到线材样品,并对其超声成像的效果进行检测;
(5)将得到的样品进行造粒,通过注塑机注塑,注塑温度为200℃,并对其力学性能进行表征。
制得的具有超声成像能力的医用导管的性能测试如图1(b)和图2。图2(a)拉伸强度,(b)冲击强度,(c)弹性模量,(d)断裂伸长率。
从图1中的(b)可以看出:TPU/RPUF=90/10的超声成像的效果不太明显,但是能看到导管材料插入的位置。
从图2中看出,当TPU/RPUF为90/10时,拉伸强度为11.2MPa,冲击强度为14.0KJ/m2,断裂伸长率285.3%,弹性模量为71.3MPa,与文献《气管导管力学性能实验研究》中国产气管导管的力学性能相比。其拉伸强度、断裂伸长率比文献中(拉伸强度为6.12MPa、断裂伸长率为41.74%)的大,而弹性模量比文献中(弹性模量为627.56MPa)的小。作为医用导管,拉伸强度和断裂伸长率大一点好,而弹性模量小一点较好,此比例下的力学性能能满足医用导管的使用要求。
实施例3
(1)按质量份准确称取聚醚多元醇(303)100份、聚醚多元醇(390)30份、三乙醇胺5.0份、去离子水1.0份、1,1,1-三羟甲基丙烷1.0份、1,4-丁二醇2.0份及硅油2.0份混合以转速为300r/min搅拌30s,静置,形成组合料(A料);
(2)准确称取异氰酸酯预聚体MDI 168份,为B料;
(3)将B料迅速倒入A料中,同时以300r/min搅拌35s后,立即将变白的物料倒入模具中自由发泡,大约6min后取出泡沫,制得硬质聚氨酯泡沫(RPUF),常温熟化之后进行切样;
(4)将步骤(3)中的切样与TPU粒料共混,TPU/RPUF为80/20,送入双螺杆挤出机进行挤出,螺杆转速为105r/min,挤出温度为190℃,经冷却后得到线材样品,并对其超声成像的效果进行检测;
(5)将得到的样品进行造粒,通过注塑机注塑,注塑温度为190℃,并对其力学性能进行表征。
制得的具有超声成像能力的医用导管的性能测试如图1(c)和图2。图2(a)拉伸强度,(b)冲击强度,(c)弹性模量,(d)断裂伸长率。
从图1中的(c)可以看出:TPU/RPUF为4时,的超声成像的效果非常明显,可以清楚的看到导管材料插入的位置,与实例1和实例2形成鲜明对比。
从图2中看出,当TPU/RPUF为4时,拉伸强度、冲击强度、断裂伸长率最小,分别为9.0MPa、6.7KJ/m2、71.9%;弹性模量最大,为109.9MPa,与文献《气管导管力学性能实验研究》中国产气管导管的力学性能相比。其拉伸强度、断裂伸长率比文献中(拉伸强度为6.12MPa、断裂伸长率为41.74%)的大,而弹性模量比文献中(弹性模量为627.56MPa)的小。作为医用导管,拉伸强度和断裂伸长率大一点好,而弹性模量小一点较好,此比例下的力学性能能满足医用导管的使用要求。
实施例4
(1)按质量份准确称取聚醚多元醇(303)100份、聚醚多元醇(390)20份、三乙醇胺4.5份、去离子水0.8份、1,1,1-三羟甲基丙烷1.5份、1,4-丁二醇2.0份及硅油2.5份混合以转速为300r/min搅拌30s,静置,形成组合料(A料);
(2)准确称取异氰酸酯预聚体MDI 170份,为B料;
(3)将B料迅速倒入A料中,同时以300r/min搅拌35s后,立即将变白的物料倒入模具中自由发泡,大约6min后取出泡沫,制得硬质聚氨酯泡沫(RPUF),常温熟化之后进行切样;
(4)将步骤(3)中的切样与TPU粒料共混,TPU/RPUF为70/30时,送入双螺杆挤出机进行挤出,螺杆转速为110r/min,挤出温度为185℃,经冷却后得到线材样品,并对其超声成像的效果进行检测;
(5)将得到的样品进行造粒,通过注塑机注塑,注塑温度为195℃,并对其力学性能进行表征。
制得的具有超声成像能力的医用导管的性能测试如图1(d)和图2。图2(a)拉伸强度,(b)冲击强度,(c)弹性模量,(d)断裂伸长率。
从图1中的(d)可以看出:TPU/RPUF=70/30的超声成像的效果和TPU/RPUF=80/20的类似,可以清楚的看到导管材料插入的位置,显影的效果非常好,与实例1和实例2形成鲜明对比。
从图2中看出,当TPU/RPUF为70/30时,拉伸强度为10.7MPa,冲击强度为11.1KJ/m2,断裂伸长率为131.9%,弹性模量为92.6MPa,与文献《气管导管力学性能实验研究》中国产气管导管的力学性能相比。其拉伸强度、断裂伸长率比文献中(拉伸强度为6.12MPa、断裂伸长率为41.74%)的大,而弹性模量比文献中(弹性模量为627.56MPa)的小。作为医用导管,拉伸强度和断裂伸长率大一点好,而弹性模量小一点较好,本实施例的力学性能能满足医用导管的使用要求。
从图1和图2中可以得出结论:
图1中的(c)和(d)超声显影的效果非常明显,可以清楚的看到导管材料插入的位置;而图1中的(a)完全不显影,(b)有显影效果,但不明显,因此与(c)和(d)形成鲜明的对比。可以得出结论,TPU/RPUF=70/30和TPU/RPUF=80/20比例下制备的导管显影的效果非常好。
图2表征了不同比例下的力学性能,(a)拉伸强度、(b)冲击强度、(c)弹性模量、(d)断裂伸长率,可以看出,随着RPUF的含量增加,拉伸强度、冲击强度、断裂伸长率先减小后增大,当TPU/RPUF=80/20时,达到最小,即拉伸强度为9.0MPa,冲击强度6.7KJ/m2,断裂伸长率为71.9%;弹性模量先增大后减小,当TPU/RPUF=80/20时,达到最大,即弹性模量为109.9MPa。与《气管导管力学性能实验研究》中国产气管导管的力学性能相比(拉伸强度为6.12MPa、断裂伸长率为41.74%、弹性模量为627.56MPa),能满足医用导管的使用要求。
最后说明的是,以上优选实施例仅用以说明本发明的技术方案而非限制,尽管通过上述优选实施例已经对本发明进行了详细的描述,但本领域技术人员应当理解,可以在形式上和细节上对其作出各种各样的改变,而不偏离本发明权利要求书所限定的范围。
Claims (9)
1.一种具有超声能力的医用导管的制备方法,其特征在于,步骤为:
1)将聚醚多元醇303、聚醚多元醇390、三乙醇胺、去离子水、1,1,1-三羟甲基丙烷、1,4-丁二醇及硅油混合搅拌,形成A料;
2)将异氰酸酯预聚体MDI作为B料;
3)将B料迅速倒入A料中,搅拌后将物料倒入模具中自由发泡,取出泡沫,制得硬质聚氨酯泡沫RPUF,常温熟化之后进行切样;
4)将步骤3)中的切样与热塑性聚氨酯TPU粒料共混,所述的TPU/RPUF的比例为2.3~4,挤出,冷却,得到线材。
2.根据权利要求1所述的一种具有超声能力的医用导管的制备方法,其特征在于,步骤1)按质量份数计,聚醚多元醇303为95~105份、所述的聚醚多元醇390为20~40份、所述的三乙醇胺为4.5~5.5份、所述的去离子水为0.5~1.0份、所述的1,1,1-三羟甲基丙烷为1.0~1.5份、所述的1,4-丁二醇为1.8~2.5份,所述的硅油为2.0~2.5份。
3.根据权利要求1所述的一种具有超声能力的医用导管的制备方法,其特征在于,步骤1)所述的混合搅拌的转速为290~310r/min,搅拌时间30~35s。
4.根据权利要求1所述的一种具有超声能力的医用导管的制备方法,其特征在于,步骤2)按质量份数计,所述的异氰酸酯预聚体MDI为165~170份。
5.根据权利要求1所述的一种具有超声能力的医用导管的制备方法,其特征在于,步骤3)所述的搅拌速度为290~310r/min,搅拌时间35~40s,发泡时间5~7min。
6.根据权利要求1所述的一种具有超声能力的医用导管的制备方法,其特征在于,步骤4)所述的TPU/RPUF的比例为80/20和70/30。
7.根据权利要求1所述的一种具有超声能力的医用导管的制备方法,其特征在于,步骤4)所述的挤出为双螺杆挤出机挤出,螺杆转速为100~110r/min,挤出温度为180℃~200℃。
8.根据权利要求1所述的一种具有超声能力的医用导管的制备方法,其特征在于,步骤1)所述的聚醚多元醇的型号为303,聚醚多元醇的型号为390。
9.根据权利要求1-8任一所述的制备方法制备得到的一种具有超声能力的医用导管,其特征在于,具有超声成像功能,其拉伸强度为9.0~18.4MPa,冲击强度为6.7~26.4KJ/m2,断裂伸长率71.9~495.9,弹性模量为65.5~109.9MPa。
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