CN116392643A - 一种基于锌铁铜合金的可降解水凝胶弹簧圈及其制备方法 - Google Patents
一种基于锌铁铜合金的可降解水凝胶弹簧圈及其制备方法 Download PDFInfo
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- CN116392643A CN116392643A CN202211732834.2A CN202211732834A CN116392643A CN 116392643 A CN116392643 A CN 116392643A CN 202211732834 A CN202211732834 A CN 202211732834A CN 116392643 A CN116392643 A CN 116392643A
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- hydrogel
- zinc
- iron
- spring ring
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- Materials For Medical Uses (AREA)
Abstract
本发明公开了一种基于锌铁铜合金的可降解水凝胶弹簧圈及其制备方法,所述可降解水凝胶弹簧圈包括弹簧圈圈体,其中,所述弹簧圈圈体内设置有水凝胶丝芯和抗解旋丝,所述弹簧圈圈体的材质按质量百分比包含如下组分:锌元素58.5%‑90.25%;铁元素1.9%‑7.6%;铜元素0.65%‑1.9%;铂钨粉5%‑35%。本发明提供的基于锌铁铜合金的可降解水凝胶弹簧圈及其制备方法,具备完全可降解性能,生物相容性好,具有致密填塞性、显影性能佳且安全可靠。
Description
技术领域
本发明涉及一种微创介入的医疗器械及其制备方法,尤其涉及一种基于锌铁铜合金的可降解水凝胶弹簧圈及其制备方法。
背景技术
动脉瘤、消化道出血、肿瘤、富血肿瘤等是动脉常见的出血性疾病。以动脉瘤为例,若瘤体破裂,患者可能危及生命。对于该类疾病的治疗以前往往需要通过外科手术的方法,风险和创伤较大,尤其对于老年患者。随着医疗科技的进步和发展,血管内介入治疗已成为此类疾病的首选治疗方案。在众多方案中,弹簧圈栓塞治疗因其安全可靠、植入稳定、输送便捷等优势脱颖而出,受到医生和研发人员的青睐。
目前,弹簧圈栓塞器械根据材料和结构可分为裸金属弹簧圈和表面修饰类弹簧圈。裸金属弹簧圈是发展历史最久也是临床最常用的弹簧圈,其圈体材料为铂钨合金,自带金属显影功能,生物相容性较好,植入病灶后因血栓机制闭塞病变部位达到治疗效果。表面修饰类弹簧圈又分生物活性表面涂层弹簧圈、水凝胶弹簧圈和带纤维毛弹簧圈。生物活性表面涂层弹簧圈是指在裸金属弹簧圈的表面涂上具有促血栓作用的药物涂层,如凝血酶原复合物、维生素K、蛇毒血凝酶和硫酸鱼精蛋白等;水凝胶弹簧圈是指在弹簧圈内有水凝胶丝芯或圈体表层有水凝胶涂层,遇血液后膨胀,增加了器械的填塞性,同时水凝胶体积的额外膨胀增加了病灶的填充率,可减少弹簧圈的植入量;带纤维毛弹簧圈是指在弹簧圈体外嵌有高分子材质的纤毛,如尼龙、聚丙烯、聚四氟乙烯和聚乙交酯-丙交酯共聚物(PGLA)等。其通过微纤毛机械重叠,在病灶处搭建致密网络,改变血流动力学,达到快速稳定致栓的效果。目前临床使用的所有弹簧圈的圈体材质均为100%的铂钨合金,不具备可降解性能。在植入物到达病灶后,由于机械闭塞或血栓机制抑制血供,但植入物会永久留在体内。对于动脉瘤而言,金属弹簧圈的植入不能使瘤体缩小,因而会持续对瘤外的神经组织进行压迫,无法消除占位效应。金属材料的长期植入也可能会产生金属毒性,对人体造成一定的损害,其远期安全性仍有待考察。此外,金属的伪影也会影响术后随访期间的影像质量,给临床医生带来些许不便。
目前,有专利文献提及使用镁基合金制备可降解弹簧圈,但镁合金在体内的降解速度过快,病灶处还未达到栓塞治疗效果就可能已经降解完全;也有专利文献提及使用聚左旋乳酸(PLLA)缝合线绕制制备可降解弹簧圈,但此圈的物理强度有待考察且能否有良好的显影效果尚且未知。
因此,为解决上述问题,开发一款具备可降解性能的,生物相容性好,具有致密填塞性、显影性能佳且安全可靠的医用弹簧圈具有重大意义。
发明内容
本发明所要解决的技术问题是提供一种基于锌铁铜合金的可降解水凝胶弹簧圈及其制备方法,具备可降解性能,生物相容性好,具有致密填塞性、显影性能佳且安全可靠。
本发明为解决上述技术问题而采用的技术方案是提供一种基于锌铁铜合金的可降解水凝胶弹簧圈,包括弹簧圈圈体,其中,所述弹簧圈圈体内设置有水凝胶丝芯和抗解旋丝,所述弹簧圈圈体的材质按质量百分比包含如下组分:
锌元素 58.5%-90.25%;
铁元素 1.9%-7.6%;
铜元素 0.65%-1.9%;
铂钨粉 5%-35%。
进一步地,所述弹簧圈圈体的材质按质量百分比包含如下组分:
锌元素 68.5%-85%;
铁元素 3%-5.8%;
铜元素 0.8%-1.55%;
铂钨粉 10%-25%。
进一步地,所述铂钨粉中,铂占总体质量百分比的92%,钨占8%。
进一步地,所述弹簧圈圈体的丝径范围在0.02-0.2mm之间,一级线圈的直径在0.05-1mm之间,二级螺旋线圈的直径在0.2-5mm之间。
进一步地,所述抗解旋丝的材质为聚丙烯、聚乙烯、聚异戊二烯、镍钛合金、镁合金、聚对二氧环己酮中的任意一种。
进一步地,所述水凝胶丝芯的材料是聚丙烯酸类凝胶、聚丙烯酰胺类凝胶、聚碳酸脂类凝胶、两亲性嵌段共聚物类凝胶、透明酯酸类凝胶、壳聚糖类凝胶、海藻酸盐类凝胶、聚乙二醇类凝胶其改性物中的任意一种。
本发明为解决上述技术问题还提供一种上述的基于锌铁铜合金的可降解水凝胶弹簧圈的制备方法,其中,包括如下步骤:步骤S1:将锌铁铜原料熔融后加入铂钨粉并混合均匀,并通过机器拉伸成丝状材料,再将金属丝由绕丝机或芯棒模具绕制成弹簧圈初始形状,最后经热处理设备高温定型,待退火后即可制得可降解弹簧圈;步骤S2:将抗解旋丝的头尾两端置入可降解弹簧圈内,并与弹簧圈的头尾两端通过焊接工艺或胶粘方式连接形成一体;步骤S3:将不同类型的致胶单体通过缩合聚合或自由基聚反应形成水凝胶,再通过离心纺丝法、湿法纺丝技术或棒状模具将水凝胶纤维拉伸成丝状,再将丝状水凝胶浸入纯化水或注射水中浸泡钝化,最后自然晾干得到水凝胶胶丝,将水凝胶丝嵌入弹簧圈圈体内。
进一步地,所述步骤S1中芯棒是直径为0.1-0.5mm之间的不锈钢棒材;细丝在绕制时,线圈之间的间隙宽度为0.0008英寸-0.008英寸,绕制角度为65°-80°;热定型温度的范围为120℃-250℃,热定型的时间为5-45分钟。
进一步地,所述步骤S2采用的胶粘剂为聚酯类、聚氨酯类、聚酰胺类、α-氰基丙烯酸酯类等胶粘剂中的任意一种或多种。
进一步地,所述步骤S3将丝状水凝胶浸入纯化水或注射水中浸泡钝化18-48小时;浸泡时,水凝胶丝的体积与浸泡液体积之比为5-10,丝状水凝胶的直径在0.01-0.3mm之间;水凝胶丝长度小于弹簧圈整体长度,且头尾两端均置于圈体内,完全膨胀后的直径不超过弹簧圈一级线圈直径。
本发明对比现有技术有如下的有益效果:本发明提供的基于锌铁铜合金的可降解水凝胶弹簧圈,栓塞致密性高、生物相容性好、显影性能优异且具备完全可降解性能,从而解决目前弹簧圈栓塞填充率低、金属植入物无法降解而产生占位效应等问题,同时又满足弹簧圈在推送过程中的显影功能。具体优点如下:
1、本发明的弹簧圈克服技术偏见,使用锌合金作为弹簧圈的主体材料,可在体内降解,且降解后的元素可为人体所用。
2、本发明的锌合金弹簧圈均匀共混铂钨粉,提供良好的X射线显影性;同时硬度高的钨又可增加弹簧圈的物理性能,在动脉瘤腔内可更好地成篮。
3、本发明的弹簧圈的主体材料为可降解锌合金,在病灶部位填塞完全后弹簧圈会逐步降解。对于动脉瘤而言,可以减少或完全消除不可降解材料带来的占位效应,减轻患者的痛苦。
4、本发明的弹簧圈内的水凝胶丝遇水或血液可在圈内快速膨胀,但不会膨胀出线圈间隙,在增加栓塞密度的同时又不会影响医生术中的推送。
附图说明
图1为本发明实施例的弹簧圈结构示意图;
图2为图1的剖面结构示意图;
图3为本发明弹簧圈治疗动脉瘤示意图。
具体实施方式
下面结合附图和实施例对本发明作进一步的描述。
图1为本发明实施例的弹簧圈结构示意图;图2为图1的剖面结构示意图。
请参见图1和图2,本发明提供的基于锌铁铜合金的可降解水凝胶弹簧圈,其主要由弹簧圈圈体10、水凝胶丝芯20和抗解旋丝30,其中弹簧圈圈体10为完全可降解弹簧圈圈体,并具有可显影微粒铂钨粉40。
弹簧圈圈体是以锌为主要元素的锌铁铜合金材料。锌是人体必不可少的一种微量元素,参与细胞的分裂和分化,可促进人体的生长发育,调控身体的免疫系统等,对维持健康有重要作用;铁元素具有能帮助人体维持免疫系统正常的功能、参与维生素A和其他微量元素的代谢等功能;铜元素具有可以促进人体骨质、内脏发育,维持人体正常血液浓度等作用。锌铁铜合金可在人体内完全降解且降解产物无毒。
将锌铁铜原料熔融后加入铂钨粉并混合均匀,并通过精密机器拉伸成丝状材料,其直径范围在0.02-0.2mm之间。再将金属丝由绕丝机或芯棒模具绕制成弹簧圈初始形状,最后经热处理设备高温定型,待退火后即可制得弹簧圈。芯棒可以是直径为0.05-1mm之间的不锈钢棒材,直径范围优选0.1-0.5mm;金属丝在绕制时,线圈之间的间隙宽度可以是0.0005英寸-0.01英寸,绕制角度可以是60°-90°,优选间隙宽度范围为0.0008英寸-0.008英寸,优选绕制角度范围为65°-80°;热定型温度的范围可以是60℃-800℃,优选温度范围为250℃-400℃;热定型的时间范围可以是3-60分钟,优选时间范围为5-45分钟。此时铂钨粉均匀分布在弹簧圈表层或圈丝中,其一级线圈的直径在0.05-1mm之间,二级螺旋圈的直径在0.2-5mm之间。通过调整锌铁铜各元素的比例,可调整弹簧圈体的柔软性、降解性、力学性能等特点。经研究,锌元素应占整体弹簧圈质量百分比的58.5%-90.25%,铁元素应占整体弹簧圈质量百分比的1.9%-7.6%,铜元素应占整体弹簧圈质量百分比的0.65%-1.9%,铂钨粉应占整体弹簧圈质量百分比的5%-35%,优选的,锌元素的质量百分比范围为68.5%-85%,铁元素的质量百分比范围为3%-5.8%,铜元素的质量百分比范围为0.8%-1.55%,铂钨粉的质量百分比范围为10%-25%。弹簧圈的降解速率会随着锌元素质量百分比的增加而增快,在此优选范围中,弹簧圈约在3-9个月内实现完全降解。在铂钨粉中,铂占总体质量百分比的92%,钨占8%。在此配方中,锌元素的质量百分比不可超过90.25%,若锌元素含量过高,则会影响弹簧圈整体的降解性能,弹簧圈会在体内因降解过快而使其尚未达到治疗效果便降解完全;而若铂钨粉含量过高,则会使得弹簧圈整体中存在较多的不可降解金属元素,可能无法消除或减少占位效应;而若铂钨粉含量过低,则会使得弹簧圈整体在X射线下显影性不佳。适量铂钨金属的加入可以提高弹簧圈的力学强度,也可增强其显影性。
抗解旋丝的材质可以是聚丙烯(PP)、聚乙烯(PE)、聚异戊二烯(PI)、镍钛合金、镁合金等中的任意一种。抗解旋丝优选聚对二氧环己酮(PDO)材质。PDO材料中的醚键赋予了其良好的柔韧性和抗拉强度,且抗弯曲疲劳性好,在常温下可弯折多次而不变形损坏。选用高分子量的PDO作为抗解旋丝,其所承受的拉力可大于1N,在术中更不容易解旋。PDO材料又具备良好的生物相容性和生物可降解性,可在体内自然降解,且PDO材质稳定,不会与弹簧圈其他组分材料发生不兼容性的反应。抗解旋丝的整体长度不超过弹簧圈长度,直径在0.01-0.3mm之间。抗解旋丝的头尾两端以焊接形式或使用胶粘剂与弹簧圈头尾两端连接形成一体。胶粘剂可以是聚酯类、聚氨酯类、聚酰胺类、α-氰基丙烯酸酯类等胶粘剂中的任意一种或多种。
水凝胶材料可以是聚丙烯酸类凝胶、聚丙烯酰胺类凝胶、聚碳酸脂类凝胶、两亲性嵌段共聚物类凝胶、透明酯酸类凝胶、壳聚糖类凝胶、海藻酸盐类凝胶、聚乙二醇类凝胶等及其改性物等中的任意一种。不同类型的致胶单体通过缩合聚合、自由基聚合等反应形成水凝胶,再通过离心纺丝法或湿法纺丝技术或其他纺丝技术,或棒状模具将水凝胶纤维拉伸成丝状,再将丝状水凝胶浸入纯化水或注射水中浸泡钝化18-48小时后,最后经无菌自然晾干得水凝胶膨胀丝。浸泡时,水凝胶丝的体积与浸泡液体积之比范围为2-15,优选范围5-10。丝状水凝胶的直径在0.01-0.3mm之间。水凝胶丝的直径、弹簧圈一级线圈直径以及浸泡液体积比之间存在直接联系,即水凝胶丝在膨胀后的最大直径不可超过一级线圈直径,以免其膨胀出一级线圈间隙。
将抗解旋丝的头尾两端置入弹簧圈圈体内,并与弹簧圈的头尾两端通过焊接工艺或胶粘技术进行连接形成一体。特殊地,抗解旋丝在弹簧圈内部靠近边缘的位置被连接,而非中心。最后将水凝胶丝嵌入弹簧圈圈体内。水凝胶丝长度小于弹簧圈整体长度,且头尾两端均置于圈体内。水凝胶丝以直线形式置于抗解旋丝空间较大的一侧,不与抗解旋丝缠绕。当水凝胶丝遇水或血液后可在弹簧圈圈体内迅速膨胀,但完全膨胀后的直径不超过弹簧圈一级线圈直径。如图3所示,15为动脉瘤瘤体、25为弹簧圈、35为血管,膨胀后的弹簧圈25几乎填满动脉瘤瘤体15。
实施例1
本实施例的基于锌铁铜合金的可降解水凝胶弹簧圈,其中锌元素占整体弹簧圈质量比的90.25%,铁元素为3.75%,铜元素为1%,铂钨粉为5%。将锌合金元素原料熔融后与铂钨粉均匀共混后,通过机器拉伸成直径范围为0.02-0.2mm之间的丝。随后将金属丝经绕丝机绕制成弹簧圈初始形状,最后经热处理设备高温定型,退火后即可制得弹簧圈。其中,一级线圈的直径在0.05-1mm之间,二级螺旋圈的直径在0.2-5mm之间。将抗解旋丝置入弹簧圈圈体中,并将其头尾两端以焊接或粘胶的形式与弹簧圈头尾两端连接,最后将水凝胶丝芯置于弹簧圈内抗解旋丝空间较大的一侧。抗解旋丝和水凝胶丝的直径范围为0.01-0.3mm之间。胶粘剂可以是是聚酯类、聚氨酯类、聚酰胺类、α-氰基丙烯酸酯类等胶粘剂中的任意一种或多种。抗解旋丝的材料可以是聚丙烯(PP)、聚乙烯(PE)、聚异戊二烯(PI)、镍钛合金、镁合金等中的任意一种;水凝胶材料可以是聚丙烯酸类凝胶、聚丙烯酰胺类凝胶、聚碳酸脂类凝胶、两亲性嵌段共聚物类凝胶、透明酯酸类凝胶、壳聚糖类凝胶、海藻酸盐类凝胶等中的任意一种。
实施例2
该实施例的整体实施过程与实施例一大体一致,与实施例一不同的是弹簧圈中不同元素的质量百分比。在该弹簧圈中锌元素占整体弹簧圈质量百分比的86%,铁元素为2.5%,铜元素为1.5%,铂钨粉为10%。
实施例3
该实施例的整体实施过程与实施例一大体一致,与实施例一不同的是弹簧圈中不同元素的质量百分比。在该弹簧圈中锌元素占整体弹簧圈质量百分比的80%,铁元素为3.6%,铜元素为1.4%,铂钨粉为15%。
实施例4
该实施例的整体实施过程与实施例一大体一致,与实施例一不同的是弹簧圈中不同元素的质量百分比。在该弹簧圈中锌元素占整体弹簧圈质量百分比的72%,铁元素为6.8%,铜元素为1.2%,铂钨粉为20%。
虽然本发明已以较佳实施例揭示如上,然其并非用以限定本发明,任何本领域技术人员,在不脱离本发明的精神和范围内,当可作些许的修改和完善,因此本发明的保护范围当以权利要求书所界定的为准。
Claims (10)
1.一种基于锌铁铜合金的可降解水凝胶弹簧圈,包括弹簧圈圈体,其特征在于,所述弹簧圈圈体内设置有水凝胶丝芯和抗解旋丝,所述弹簧圈圈体的材质按质量百分比包含如下组分:
锌元素58.5%-90.25%;
铁元素1.9%-7.6%;
铜元素0.65%-1.9%;
铂钨粉5%-35%。
2.如权利要求1所述的基于锌铁铜合金的可降解水凝胶弹簧圈,其特征在于,所述弹簧圈圈体的材质按质量百分比包含如下组分:
锌元素68.5%-85%;
铁元素3%-5.8%;
铜元素0.8%-1.55%;
铂钨粉10%-25%。
3.如权利要求1所述的基于锌铁铜合金的可降解水凝胶弹簧圈,其特征在于,所述铂钨粉中,铂占总体质量百分比的92%,钨占8%。
4.如权利要求1所述的基于锌铁铜合金的可降解水凝胶弹簧圈,其特征在于,所述弹簧圈圈体的丝径范围在0.02-0.2mm之间,一级线圈的直径在0.05-1mm之间,二级螺旋线圈的直径在0.2-5mm之间。
5.如权利要求1所述的基于锌铁铜合金的可降解水凝胶弹簧圈,其特征在于,所述抗解旋丝的材质为聚丙烯、聚乙烯、聚异戊二烯、镍钛合金、镁合金、聚对二氧环己酮中的任意一种。
6.如权利要求1所述的基于锌铁铜合金的可降解水凝胶弹簧圈,其特征在于,所述水凝胶丝芯的材料是聚丙烯酸类凝胶、聚丙烯酰胺类凝胶、聚碳酸脂类凝胶、两亲性嵌段共聚物类凝胶、透明酯酸类凝胶、壳聚糖类凝胶、海藻酸盐类凝胶、聚乙二醇类凝胶其改性物中的任意一种。
7.一种如权利要求1-6任一项所述的基于锌铁铜合金的可降解水凝胶弹簧圈的制备方法,其特征在于,包括如下步骤:
步骤S1:将锌铁铜原料熔融后加入铂钨粉并混合均匀,并通过机器拉伸成丝状材料,再将金属丝由绕丝机或芯棒模具绕制成弹簧圈初始形状,最后经热处理设备高温定型,待退火后即可制得可降解弹簧圈;
步骤S2:将抗解旋丝的头尾两端置入可降解弹簧圈内,并与弹簧圈的头尾两端通过焊接工艺或胶粘方式连接形成一体;
步骤S3:将不同类型的致胶单体通过缩合聚合或自由基聚反应形成水凝胶,再通过离心纺丝法、湿法纺丝技术或棒状模具将水凝胶纤维拉伸成丝状,再将丝状水凝胶浸入纯化水或注射水中浸泡钝化,最后自然晾干得到水凝胶胶丝,将水凝胶丝嵌入弹簧圈圈体内。
8.如权利要求7所述的基于锌铁铜合金的可降解水凝胶弹簧圈的制备方法,其特征在于,所述步骤S1中芯棒是直径为0.1-0.5mm之间的不锈钢棒材;细丝在绕制时,线圈之间的间隙宽度为0.0008英寸-0.008英寸,绕制角度为65°-80°;热定型温度的范围为120℃-250℃,热定型的时间为5-45分钟。
9.如权利要求6所述的基于锌铁铜合金的可降解水凝胶弹簧圈的制备方法,其特征在于,所述步骤S2采用的胶粘剂为聚酯类、聚氨酯类、聚酰胺类、α-氰基丙烯酸酯类等胶粘剂中的任意一种或多种。
10.如权利要求6所述的基于锌铁铜合金的可降解水凝胶弹簧圈的制备方法,其特征在于,所述步骤S3将丝状水凝胶浸入纯化水或注射水中浸泡钝化18-48小时;浸泡时,水凝胶丝的体积与浸泡液体积之比为5-10,丝状水凝胶的直径在0.01-0.3mm之间;水凝胶丝长度小于弹簧圈整体长度,且头尾两端均置于圈体内,完全膨胀后的直径不超过弹簧圈一级线圈直径。
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