CN108853608A - 一种生物可降解的医用镁合金补片及其制备方法和用途 - Google Patents
一种生物可降解的医用镁合金补片及其制备方法和用途 Download PDFInfo
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Abstract
本发明提供了一种生物可降解的医用镁合金补片及其制备方法和用途,属于医用耗材的技术领域。其特点是采用由截面为圆形、椭圆形或长方形(扁条状)的镁合金丝材编织成多孔的网状结构,所述网状结构上设有可吸收涂层。该补片还可通过压合可吸收膜层,制备成不同的带覆膜补片,应用于不同的临床手术适应症。本发明制备的补片具有低厚度,高强度、柔韧性和生物相容性好等优点,并且植入人体后一定时间内维持较高的力学性能,同时在患者伤口愈合后可降解被人体所吸收,在体内无残留,减轻患者愈合后期的不适感和不良反应。
Description
技术领域
本发明涉及医疗器械领域,特别涉及一种生物可降解的医用镁合金补片及其制备方法和用途,属于医用耗材的技术领域。
背景技术
补片在疾病治疗以及整形外科中均有广泛的临床应用。一方面,许多的疾病治疗需要使用组织修复补片。例如:胸壁、腹壁等部位大块组织缺损的修复十分困难,临床手术治疗的过程中常用到补片。其次,疝是指脏器离开原来的部位,通过人体的薄弱点或缺损、孔隙进入另一部位,手术治疗的过程中也需要用到补片。再次,女性盆底功能障碍性疾病以压力性尿失禁、盆腔器官脱垂以及慢性盆腔疼痛等为主要病症的一种妇科疾病,大量研究表明,利用盆底补片实现盆底重建,与传统的子宫切除手术方式相比,提高了手术的安全性,并改善术后病人生活质量。再者,垂体瘤是颅内常见肿瘤,颅内发病率居第三位,约占颅内肿瘤的10%,是一种从垂体前叶和后页以及颅咽管上皮残余细胞发生的肿瘤,现在临床应用最多的内镜经鼻-蝶窦垂体瘤切除术,手术的入路是经鼻孔进入蝶窦,打开鞍底,切除肿瘤,在打开鞍底的过程中,会造成骨缺损破坏,现用的手术修补方法通常是补片填补在骨缺损开口处。另一方面,随着社会的发展,生活水平的提高,整形手术也越来越普及,其中乳房整形术就是最为常见的一种整形手术之一,在乳房整形术中最为常见的是隆乳术、乳房下垂矫正术、乳房修复术以及乳房重建术;在这些乳房整形术中,通常需要将乳房假体植入胸大肌,在术后患者经常出现肌体对异物的排斥反应,还会出现假体移位、下垂等并发症,给患者造成巨大的痛苦。
目前应用较多的人工补片材料主要包括聚丙烯网(如Marlex、Prolene等)、聚四氟乙烯补片(PTFE、Gore-Tex补片)、聚酯网片(如Dacron、Mersilene)涤纶补片等。目前,上述的补片多为高分子材料且不能降解或是部分降解。这些传统的人工材料植入体内会增加伤口感染的机会,术后感染是其最大的并发症,且感染后必须二次手术取出。因此开发具有更好的生物相容性的补片材料依旧是一项极具有意义的工作。
镁是人体内必须的营养元素,镁元素分布在人体的各个部位,如骨骼肌、肌肉、细胞外液及血浆中,而且其含量仅次于Ca、K、Na排第四位。而且,在细胞内,Mg2+可催化或激活机体325种酶系,参与体内所有能量代谢,对肌肉收缩、神经运动机能、生理机能及预防循环系统疾病和缺血性心脏病有重要作用。同时,由于镁金属具有较低的腐蚀电位,在含有氯离子的体液环境中能发生腐蚀降解。此外,世界卫生组织建议成人每天需要摄镁量为280-300mg,少年儿童为250mg,婴幼儿80mg。过量的镁可通过泌尿系统排出体外,镁在人体内吸收不会导致血清镁含量的明显升高。由上可见,镁合金可放心的应用于临床植入材料。
公开号为CN 106361476A的专利中,公开了一种编织型全降解镁合金气道支架及其制备方法,该镁合金气道支架采用直径0.1mm~0.5mm的镁合金丝材一体化编织而成,镁合金气道支架表面网眼为四边形,单个网眼面积为2mm2~10mm2,所述直径0.1mm~0.5mm的镁合金丝材在编织时为单丝或双丝或多丝。但该专利中得到的镁合金道支架主要应用于气道疾病的治疗,编织后的形状为管形,且本发明研究发现,并不是所有的镁合金都可以用来进行编织后应用;在该专利中镁合金丝材在降解的过程中容易出现降解不均匀,而导致产品早期因局部腐蚀降解而失效。此外,镁合金直接植入应用时由于其腐蚀降解速率较快,也不能得到一个比较好的治疗效果。
发明内容
针对现有技术中的缺陷,本发明的目的在于提供一种生物可降解的医用镁合金补片及其制备方法,该镁合金补片能满足不同修复要求,能修复缺损且能逐渐降解吸收。
本发明的目的是通过以下技术方案来实现的:
第一方面,本发明提供一种生物可降解的医用镁合金补片,所述补片是由镁合金丝材编织成的多孔的网状结构,所述网状结构上设有可吸收涂层,所述镁合金丝材的横截面为圆形、椭圆形或长方形(扁条状)。圆形丝材制备最工艺简单,但是相对于椭圆形或长方形丝材来说,编织后的补片的厚度更大。
优选地,所述镁合金为Mg-Zn-Zr镁合金、Mg-Zn-Gd镁合金或Mg-Nd-Zn-Zr镁合金。上述三种镁合金体外表征及动物实验结果效果良好,且所述镁合金为含无明显毒性元素制备而成生物相容性良好。
优选地,所述丝材编织可以多样化。一方面可以灵活选择使用单丝或者多丝进行编织,此外还可以使用不同交叉形式以及不同的角度来进行编织。附图1和2为本发明中两种比较典型的单丝编织方式。
优选地,所述镁合金丝材为单丝或由多根单丝编织而成的单元。
优选地,所述镁合金丝材的截面积为0.0028-0.3mm2。
优选地,根据临床应用要求所述补片的厚度为0.1-1mm,单个网孔的面积为0.1-10mm2。编织用丝材的粗细不同决定了最终编织出来的产品的厚度,丝过细一方面难以加工,此外丝材编织成的补片的力学性能也会较差,然而丝材过粗,虽然力学性能比较好,但是柔韧性较差,同时降解吸收的所需要的时间会过长。丝材的编织方式决定了个网孔的面积,面积过小一方面浪费了更多的丝材,另一方面不方便各类营养物质的传输。网孔面积过大,则产品的力学性能过低,不足以达到用作补片所需的强度要求。
优选地,所述可吸收涂层的制备方法可参照专利CN 201510351233.0、CN201310306991.1、或CN 201510564506.X。其中,可吸收涂层也称可降解涂层。
优选地,所述补片上覆盖有可吸收膜层。
更优选地,所述可吸收膜层为聚丙交-己内酯共聚物可吸收膜层或聚己酸内酯-磷酸三钙可吸收膜层。所述补片在临床应用时还可压合聚丙交-己内酯共聚物或聚己酸内酯-磷酸三钙等可吸收膜层后作为覆膜补片来使用。
第二方面,本发明提供一种生物可降解的医用镁合金补片的制备方法,所述制备方法包括如下步骤:
S1、将圆柱形镁合金棒材进行机加工车削,得到圆柱形挤丝用坯料;
S2、将圆柱形挤丝用坯料进行热挤压,得到丝材毛坯;
S3、对丝材毛坯进行拉拔、轧制变形并辅助以热处理,得镁合金单丝。
S4、将镁合金单丝或由多根镁合金单丝编织而成的单元在编机上编织成网,经电解抛光、清洗、涂层处理、干燥、灭菌处理,得所述镁合金补片。
优选地,步骤S2中,所述丝材毛坯的直径为
优选地,步骤S2中,所述热挤压的工艺条件为:挤压温度为250℃至350℃范围内,挤压比在20至60范围内。
优选地,步骤S3中,所述拉拔的工艺条件为:每道次拉拔变形量不超过20%;所述轧制变形的工艺条件为:室温冷轧;所述热处理的工艺条件为:300℃至450℃退火30分钟至2小时。
优选地,步骤S4中,对所述镁合金补片进一步进行覆膜处理。当所述镁合金补片用作覆膜补片时,还需要进一步的进行覆膜处理。
第三方面,本发明提供一种生物可降解的医用镁合金补片在作为疝修复手术、盆腔脏器脱垂手术、胸壁修复手术、脑垂体腺瘤手术或整形外科手术用组织修复补片的用途。所述的镁合金丝材编织成的多孔网状结构经过涂层处理和选择性的覆膜处理后,可应用于疝修复、盆腔脏器脱垂手术、胸壁修复、脑垂体腺瘤手术等,也可应用于乳房、男性生殖器等整形外科手术。
本发明制备的补片具有低厚度,高强度、柔韧性和生物相容性好等优点,并且植入人体后一定时间内维持较高的力学性能,同时在患者伤口愈合后可降解被人体所吸收,在体内无残留,减轻患者愈合后期的不适感和不良反应。
与现有技术相比,本发明具有如下的有益效果:
(1)补片可完全降解,在疾病恢复的过程中逐渐被人体所吸收代谢,补片植入初期具有良好的支撑作用,后期待组织修复完成后完全降解吸收为自体组织取代,可避免传统材料可能带来的远期并发症。
(2)通过调整丝材的尺寸、外观以及编织方法,可得到不同类型的镁合金补片,其具有不同的强度及降解吸收时间,可适合不同的病况。
(3)针对不同的病症,补片的降解速度以及生物相容性可通过涂层处理和覆膜处理进行进一步的调控和改善,以满足不同部位及器官组织修复的要求。
(4)镁合金密度小,制备的补片的质量轻,且镁合金在降解的过程中使植入部位产生微碱性的局部微环境,从而会使得手术后的伤口部位具有一定的抗菌消炎的长期效果,有利于伤口的愈合。
(5)本专利中所编织的产品用作补片用途,同时编织后的产品为平面状,还可根据治疗的时的需求进行任意形状的裁剪。本专利中明确提出了使用Mg-Zn-Zr镁合金、Mg-Zn-Gd镁合金或Mg-Nd-Zn-Zr镁合金这几类典型的合金来进行编织用丝材的制备,主要是用来保证产品的力学性能的同时还保证丝材在降解的过程中均匀降解,从而防止产品早期因局部腐蚀降解而失效。
(6)本专利还提出了编织后的网状结构在应用时需要制备一层可降解涂层,涂层的制备一方面有效的降低了腐蚀降解的速率,另一方面也大大提高了产品的生物活性,使得本专利中所述的可降解镁合金补片在临床上具有良好的应用前景。本专利中所述的补片相对于公开号为CN 106361476A的专利中所述的全降解镁合金气道支架,一方面改善了其腐蚀降解性能,同时改善了产品的生物相容性能,且应用治疗的疾病类型完全不同,应用的范围更广。
附图说明
通过阅读参照以下附图对非限制性实施例所作的详细描述,本发明的其它特征、目的和优点将会变得更明显:
图1为本发明制备的镁合金补片的交叉编织方式一的示意图;
图2为本发明制备的镁合金补片的交叉编织方式二的示意图。
具体实施方式
下面结合具体实施例对本发明进行详细说明。以下实施例将有助于本领域的技术人员进一步理解本发明,但不以任何形式限制本发明。应当指出的是,对本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变化和改进。这些都属于本发明的保护范围。
车削一定高度的圆柱形挤丝用坯料;将圆柱形挤丝用坯料,进行一定温度下的热挤压,得直径为的丝材毛坯;对丝材毛坯进行多道次拉拔、轧制变形并辅助以热处理,可得不同丝径的细丝材。
本发明中制备的生物可降解的医用镁合金补片的交叉编织方式可以如图1所示,也可以如图2所示。
实施例1
本实施例涉及一种生物可降解的医用镁合金补片及其制备方法,具体制备方法如下:
1)利用上述方法制备得到的截面为圆形且直径为0.08mm的Mg-Zn-Zr细丝材在编机上编织成网,可任意裁剪。
2)经电解抛光,清洗;
3)可降解涂层处理。
4)干燥、包装、灭菌处理后待用。
最终产品的厚度为0.16mm,单个网孔面积为0.1mm2。
实施例2
本实施例涉及一种生物可降解的医用镁合金补片及其制备方法,具体制备方法如下:
1)利用上述方法制备得到的截面为椭圆形,长轴为0.07mm,短轴为0.05mm的Mg-Zn-Gd基合金细丝材在编机上编织成网,可任意裁剪。
2)经电解抛光,清洗。
3)可降解涂层处理。
4)干燥、包装、灭菌处理后待用。
最终产品的厚度为0.2mm,单个网孔面积为2mm2。
实施例3
本实施例涉及一种生物可降解的医用镁合金补片及其制备方法,具体制备方法如下:
1)利用上述方法制备得到的截面形状为矩形的,长边为0.5mm,宽为0.3mm扁条状Mg-Nd-Zn-Zr细丝材在编机上编织成网,可任意裁剪。
2)经电解抛光,清洗。
3)可降解涂层处理,然后压合一层PLCL可吸收膜层(聚丙交-己内酯共聚物)。
4)干燥、包装、灭菌处理后用作腹壁疝修补网片。
最终产品的厚度为0.8mm,网面单个网孔面积为10mm2。
实施例4
本实施例涉及一种生物可降解的医用镁合金补片及其制备方法,具体制备方法如下:
1)利用上述方法制备得到的3根截面为圆形的直径为0.1mm Mg-Zn-Gd基合金细丝材在编机上编织成细绳。利用细绳在编机上编织为网,可任意裁剪。
2)经电解抛光,清洗。
3)可降解涂层处理,然后压合一层PCL-TCP可吸收膜层(聚己酸内酯-磷酸三钙)。
4)干燥、包装、灭菌处理后用作脑垂体腺瘤手术补片。
最终产品的厚度为1.0mm,网面单个网孔面积为3mm2。
用于不同部位的补片需具备不同的机械性能与降解速度。可根据实际情况对补片进行调控。所用丝材的强度可在150MPa~400MPa范围内波动,镁合金丝材的延伸率在10%~30%范围内。编织成的多孔的网状结构,在涂层处理后降解周期为6个月~24个月可控。
以上对本发明的具体实施例进行了描述。需要理解的是,本发明并不局限于上述特定实施方式,本领域技术人员可以在权利要求的范围内做出各种变化或修改,这并不影响本发明的实质内容。在不冲突的情况下,本申请的实施例和实施例中的特征可以任意相互组合。
Claims (10)
1.一种生物可降解的医用镁合金补片,其特征在于,所述补片是由镁合金丝材编织成的多孔的网状结构,所述网状结构上设有可吸收涂层,所述镁合金丝材的横截面为圆形、椭圆形或长方形。
2.根据权利要求1所述的生物可降解的医用镁合金补片,其特征在于,所述镁合金为Mg-Zn-Zr镁合金、Mg-Zn-Gd镁合金或Mg-Nd-Zn-Zr镁合金。
3.根据权利要求1所述的生物可降解的医用镁合金补片,其特征在于,所述镁合金丝材为单丝或由多根单丝编织而成的单元。
4.根据权利要求1或3所述的生物可降解的医用镁合金补片,其特征在于,所述镁合金丝材的截面积为0.0028-0.3mm2。
5.根据权利要求1所述的生物可降解的医用镁合金补片,其特征在于,所述补片的厚度为0.1-1mm,单个网孔的面积为0.1-10mm2。
6.根据权利要求1所述的生物可降解的医用镁合金补片,其特征在于,所述补片上覆盖有可吸收膜层。
7.根据权利要求6所述的生物可降解的医用镁合金补片,其特征在于,所述可吸收膜层为聚丙交-己内酯共聚物可吸收膜层或聚己酸内酯-磷酸三钙可吸收膜层。
8.一种根据权利要求1所述的生物可降解的医用镁合金补片的制备方法,其特征在于,所述制备方法包括如下步骤:
S1、对圆柱形镁合金棒材进行机加工车削,得到圆柱形挤丝用坯料;
S2、将圆柱形挤丝用坯料进行热挤压,得到丝材毛坯;
S3、对丝材毛坯进行拉拔、轧制变形并辅助以热处理,得镁合金单丝。
S4、将镁合金单丝或由多根镁合金单丝编织而成的单元在编机上编织成网,经电解抛光、清洗、涂层处理、干燥、灭菌处理,得所述镁合金补片。
9.根据权利要求8所述的生物可降解的医用镁合金补片的制备方法,其特征在于,步骤S4中,对所述镁合金补片进一步进行覆膜处理。
10.一种根据权利要求1所述的生物可降解的医用镁合金补片在作为疝修复手术、盆腔脏器脱垂手术、胸壁修复手术、脑垂体腺瘤手术或整形外科手术用组织修复补片的用途。
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CN114452448A (zh) * | 2022-02-18 | 2022-05-10 | 常熟致圆微管技术有限公司 | 一种生物可降解的医用金属镁支架的制备方法 |
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