CN106178231A - 医用双层耐高压球囊及其制备方法 - Google Patents
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Abstract
本发明公开了一种医用双层耐高压球囊及其制备方法,医用双层耐高压球囊包括两端开口的球囊本体,所述球囊本体为双层结构,它包括位于外层的硬质层和位于内层的软质层;或所述球囊本体包括位于外层的软质层和位于内层的硬质层。本发明所提供的医用双层耐高压球囊通过采用软硬双层复合材料制作,有效增大了球囊***压力的同时,也能够使得球囊本身具有一定的柔性,在作为心血管球囊导管和外周血管球囊导管使用时,能够有效增强球囊的穿越性。
Description
技术领域
本发明涉及一种医用球囊,具体地指一种医用双层耐高压球囊及其制备方法。
背景技术
现有市售的血管用扩张球囊型号众多,但是大多数由单层材料一体成型制成。
目前市售的高压球囊导管产品,如强生的高压球囊NC Empira的材料为硬质单层尼龙材料,额定***压力(Rated Burst Pressure)为20atm,由于材料本身质地较硬,在球囊折叠工艺过程中,材料本身内应力会使球囊的贴合不够,容易造成膨散等缺点,使球囊整体的通过性降低;波士顿科学的NC Quantum Apex Monorail则为较软的单层Pebax材料,额定***压力(RBP)也为20atm,较软的材料要达到20atm的高压要求则会增加球囊本身的厚度,这又会增加球囊折叠的困难,与上述硬性材料所产生的问题一样,使球囊导管通过病变区域的能力下降。
发明内容
本发明的目的就是要克服现有医用球囊所存在的不足,提供一种抗压性强、柔软性好的医用双层耐高压球囊及其制备方法,本发明球囊特别适合作为心血管球囊导管和外周血管球囊导管使用。
为实现上述目的,本发明所设计的医用双层耐高压球囊,包括两端开口的球囊本体,所述球囊本体为双层结构,它包括位于外层的硬质层和位于内层的软质层;
或所述球囊本体包括位于外层的软质层和位于内层的硬质层。
上述方案中,所述硬质层的成分优选为尼龙(PA)、聚甲基乙烯酸甲酯(PMMA)、聚对苯二甲酸乙二醇脂(PET)、聚乙烯(PE),聚丙烯(PP)中一种或几种的组合。
上述方案中,所述软质层的成分优选为Pebax、聚氯乙烯(PVC)、聚氨酯(PU)、硅橡胶中一种或几种的组合。
上述方案中,所述硬质层的材料硬度为91~130D,所述软质层的材料硬度为40~90D。通过研究发现采用软硬不同的双层材料,既能够大大增强球囊材料的强度,大大提高球囊的***压力,又可以保证球囊成品不至于过厚,而软质材料和硬质材料在符合上述硬度范围时,效果较佳。
本发明还提供了一种上述医用双层耐高压球囊的制备方法,其步骤如下:
(1)将用于制作所述球囊的硬质层的原材料和软质层的原材料,在温度100~300℃,挤出速度为2~20HZ的条件下,采用双层共挤出法制得双层挤出管;
(2)将双层挤出管一端密封,另一端充入高压气体;
(3)加热双层挤出管至60~220℃,并控制其内部高压气体的压力为10~80psi,使双层挤出管充分软化膨胀;
(4)以速度0.2~50cm/s的速度拉伸双层挤出管两端,保持压力和温度10~60s使其定型,冷却后取出双层挤出管,再于35~65℃烘干定型20~60分钟,得到所述医用双层耐高压球囊。
上述方案中,所述硬质层的成分优选为尼龙(PA)、聚甲基乙烯酸甲酯(PMMA)、聚对苯二甲酸乙二醇脂(PET)、聚乙烯(PE),聚丙烯(PP)中一种或几种的组合。
上述方案中,所述软质层的成分优选为Pebax、聚氯乙烯(PVC)、聚氨酯(PU)、硅橡胶中一种或几种的组合。
上述方案中,所述硬质层的材料硬度为91~130D,所述软质层的材料硬度为40~90D。
本发明的有益效果:所提供的医用双层耐高压球囊通过采用软硬双层复合材料制作,有效增大了球囊***压力的同时,也能够使得球囊本身具有一定的柔性,在作为心血管球囊导管和外周血管球囊导管使用时,能够有效增强球囊的穿越性。
附图说明
图1为本发明的医用双层耐高压球囊的剖视结构示意图。
具体实施方式
以下结合附图和具体实施例对本发明作进一步的详细描述。
实施例1
如图1所示,医用双层耐高压球囊,包括两端开口的球囊本体1,所述球囊本体1为双层结构,它包括位于外层的硬质层1.1和位于内层的软质层1.2。实际上,硬质层1.1和软质层1.2的位置可以互换,即软质层1.2位于外层,硬质层1.1位于内层,同样可以实现本发明。
硬质层的成分为硬度95D的尼龙,软质层的成分为硬度70D的聚氨酯。
实施例2
本实施例医用双层耐高压球囊与实施例1结构相同,不同点在于硬质层的成分为硬度100D的PMMA,软质层的成分为硬度50D的Pebax。
实施例3
本实施例医用双层耐高压球囊与实施例1结构相同,不同点在于硬质层的成分为硬度105D的PE,软质层的成分为硬度80D的聚PVC。
实施例4
本实施例医用双层耐高压球囊与实施例1结构相同,不同点在于硬质层的成分为硬度100D的聚对苯二甲酸乙二醇脂,软质层的成分为硬度40D的硅橡胶。
实施例5
本实施例医用双层耐高压球囊与实施例1结构相同,不同点在于硬质层的成分为硬度130D的PE,软质层的成分为硬度90D的聚PVC。
上述医用双层耐高压球囊的制备方法,步骤如下:
(1)将用于制作所述球囊的硬质层1.1的原材料和软质层1.2的原材料分别置于挤出机的不同料筒中,调节挤出机的料筒温度为100~300℃,挤出速度为2~20HZ,采用双层共挤出法制得双层挤出管;
(2)将双层挤出管放置于球囊成型模具内,一端采用机械夹紧密封,另一端***气体针密封,充入高压气体如氮气等;
(3)对球囊成型模具进行加热,加热温度为60~220℃,并控制其内部高压气体的压力为10~80psi,使双层挤出管充分软化膨胀后贴紧模具内壁;
(4)以速度0.2~50cm/s的速度拉伸双层挤出管两端,保持压力和温度10~60s使其定型,冷却后取出双层挤出管,在置于35~65℃的烘箱中定型20~60分钟,得到上述医用双层耐高压球囊。
将上述实施例中得到的医用双层耐高压球囊进行抗压性能测试,结果见下表。
表中显示,经检测本发明所制备的医用双层耐高压球囊抗压性能较市售产品有所增强。
Claims (8)
1.一种医用双层耐高压球囊,包括两端开口的球囊本体,其特征在于:所述球囊本体为双层结构,它包括位于外层的硬质层和位于内层的软质层;
或所述球囊本体包括位于外层的软质层和位于内层的硬质层。
2.根据权利要求1所述的医用双层耐高压球囊,其特征在于:所述硬质层的成分为尼龙、聚甲基乙烯酸甲酯、聚对苯二甲酸乙二醇脂、聚乙烯、聚丙烯中一种或几种的组合。
3.根据权利要求1所述的医用双层耐高压球囊,其特征在于:所述软质层的成分为Pebax、聚氯乙烯、聚氨酯、硅橡胶中一种或几种的组合。
4.根据权利要求1所述的医用双层耐高压球囊,其特征在于:所述硬质层的材料硬度为91~130D,所述软质层的材料硬度为40~90D。
5.权利要求1所述医用双层耐高压球囊的制备方法,其特征在于,步骤如下:
(1)将用于制作所述球囊的硬质层的原材料和软质层的原材料,在温度100~300℃,挤出速度为2~20HZ的条件下,采用双层共挤出法制得双层挤出管;
(2)将双层挤出管一端密封,另一端充入高压气体;
(3)加热双层挤出管至60~220℃,并控制其内部高压气体的压力为10~80psi,使双层挤出管充分软化膨胀;
(4)以速度0.2~50cm/s的速度拉伸双层挤出管两端,保持压力和温度10~60s使其定型,冷却后取出双层挤出管,再于35~65℃烘干定型20~60分钟,得到所述医用双层耐高压球囊。
6.根据权利要求5所述医用双层耐高压球囊的制备方法,其特征在于:所述硬质层的成分为尼龙、聚甲基乙烯酸甲酯、聚对苯二甲酸乙二醇脂、聚乙烯、聚丙烯中一种或几种的组合。
7.根据权利要求5或6所述医用双层耐高压球囊的制备方法,其特征在于:所述软质层的成分为Pebax、聚氯乙烯、聚氨酯、硅橡胶中一种或几种的组合。
8.根据权利要求5所述医用双层耐高压球囊的制备方法,其特征在于:所述硬质层的材料硬度为91~130D,所述软质层的材料硬度为40~90D。
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CN106821564A (zh) * | 2016-12-29 | 2017-06-13 | 凯斯蒂南京医疗器械有限公司 | 一种双球囊导管支架 |
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CN114261080A (zh) * | 2021-12-16 | 2022-04-01 | 科睿驰(深圳)医疗科技发展有限公司 | 一种球囊的成型方法 |
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CN115445059A (zh) * | 2022-10-14 | 2022-12-09 | 恒壹(北京)医疗科技有限公司 | 一种自动导向球囊导管及使用方法 |
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