CN112826988B - 一种可定向降解自脱落镁金属胆道支架及其制备方法 - Google Patents
一种可定向降解自脱落镁金属胆道支架及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种可定向降解自脱落镁金属胆道支架及其制备方法，胆道支架包括螺旋形支架主体、头部卡扣和尾部卡扣。卡扣由特定分子量的可降解高分子材料制成，制成头部卡扣的高分子材料的分子量小于尾部卡扣。支架主体的外表面设有高分子涂层，可载覆抗结石或抗癌药物。本发明通过将支架主体设计为螺旋结构，保证支架主体具有一定的支撑力学强度和足够的柔顺性；本发明的胆道支架各部分采用不同的材料，支架植入胆道后头部卡扣先降解，支架主体和尾部卡扣后降解，可避免卡在胆管出口的尾部卡扣先降解，从而防止胆道支架上行滑入肝内引起严重损伤。既解决了永久支架存在的问题，又保证固定牢固、降解过程对机体安全，减少对胆道的机械损伤。
Description
技术领域
本发明涉及一种可定向降解自脱落镁金属胆道支架及其制备方法，属于医疗器械技术领域。
背景技术
胆道梗阻是临床上常见的消化系统疾病，可分为良性梗阻和恶性梗阻。良性梗阻一般是由于胆管损伤或者胆管炎反复发作、瘢痕性狭窄所致。恶性梗阻主要是肝癌、胰腺癌、胆管癌等恶性肿瘤所致。胆道梗阻会导致胆汁淤积，极可能对肝细胞造成不可逆损害，临床表现有腹痛、高热、间歇性黄疸等。长期胆道梗阻会导致肝功能恶化、消化道出血、肾衰竭等并发症，严重者危及生命，因此必须及时治疗，如通过球囊扩张撑开胆管使其畅通或者置入支架/引流管等减压引流。不过球囊扩张法再狭窄率高，目前应用已较少。引流管和支架则为当前常见治疗方法。引流管一般为T型乳胶管，支架则包括塑料胆管支架和自膨胀支架，自膨胀支架一般又分为覆膜和不覆膜两种，为镍钛记忆合金丝编织而成，支撑强度高、弹性好、可迅速恢复胆管通畅。引流管和支架治疗早期效果明显，在胆道梗阻治疗方面得到广泛应用，但目前依然存在诸多不足之处，最典型的问题依然是再狭窄。塑料胆管支架容易被胆道结石或泥沙样胆道泥再次堵塞，只能通过多次内镜手术反复治疗，并需要定期更换，一般更换周期为3-6个月，无疑大幅度增加了患者的痛苦和经济负担。对于自膨胀无覆膜支架而言，其镂空结构会刺激肉芽增生，引起内腔狭窄甚至再次堵塞，且由于镂空结构被增生组织包覆后极难取出，只能再次插入塑料支架管治疗，无论对患者恢复还是后续治疗均非常不利，而且记忆合金容易释放对人体有毒性的镍离子。覆膜自膨胀支架虽然能解决肉芽增生狭窄问题，但会挡住胆囊管出口，适应症受到很大限制。
总之，当前常用的不可降解吸收胆道支架在人体内长期存在，在治疗疾病的同时也引起了一系列问题。针对该情况，可降解的胆道支架逐渐成为研究热点。Ginsberg G等报道了一种可被人体降解的胆道支架(Ginsberg G et al.GastrointestinalEndoscopy.2003,58(5):777-784.)，具有一定前景，然而术后依然会发生胆道感染和胆结石，支架容易被再次堵塞，还需进一步改进。在此基础上有文献报道了载药的高分子支架。高分子材料可以方便地通过吸附接枝等手段携带缓释药物，达到防止再狭窄和感染的目的。如国家专利“生物可降解的药物复合高分子支架材料的制备方法”(公开号CN1367023)，介绍了一种可降解高分子药物复合支架的制备方法，该支架可被降解吸收，携带显影剂在X射线下可视，同时还载有抑制组织增生的药物从而预防组织狭窄功能。中国专利《X射线下可视的多层药物复合可降解胆道支架的制备方法》(申请号CN200410062260.8)公开了一种通过将带有药物和显影剂的高分子细丝缠绕的工艺，制成了可被人体降解并脱落至肠道的胆道支架。专利《一种可吸收胆道支架及其制备方法》(申请号CN201510320793.X)则公开了一种经激光切割的方式制成的高分子胆道支架，材质主要是聚乳酸或聚乙交酯的一种或共聚物，载有抗肿瘤药物或者抗胆结石药物。
不过目前大部分可降解胆道支架均为聚乳酸等的材料，降解时间比较漫长，在胆道存在时间过长的话会再一次引起胆结石或者泥沙样沉积阻塞，且表明可能会形成微生物的生物膜而导致感染。同时可降解高分子一般力学性能较低，其抗拉强度普遍不超过100MPa，导致支撑力较低、难以紧密贴合病变部位而容易发生移位，至少应用范围收到严重限制。这是目前可降解的高分子支架应用的不利因素。
可降解镁合金由于具有较高的强度、可降解吸收、生物相容性良好而受到生物医用材料研究人员的广泛关注。中国专利《生物可吸收医用人体腔道内支架及其制备方法》(申请号CN201210424030.6)公开了一种镁合金丝材编制人体腔道支架的方法，带有生物陶瓷涂层，附着有药物和X光显影剂，能够在人体内被降解吸收及脱落。不过此类镁合金支架为镁丝编制而成，丝材直径较小，降解容易有点蚀引起的局部断裂，可能会出现早期断裂失效。中国专利《镁合金在制备可降解胆道支架中的应用》(申请号CN201810685446.0)公开了一种球囊扩张的网状支架，在动物体内降解周期为8周。
上述可降解吸收的高分子或者镁合金支架均为单一材质，可降解高分子存在的不足是强度较低、支撑力受到限制。可降解镁及其他可降解金属如锌合金或者铁存在的不足是弹性较低、柔顺性不佳。实际上在临床使用中必须要考虑和ERCP(经内镜逆行性胰胆管造影术)系统配合的问题，故必须通过特殊的结构设计、保证镁金属支架具有足够柔顺性从而可穿过复杂曲折的管道通路，且外表面应光洁，否则会刮伤ERCP系统的内表面。另外支架应在胆道内牢固固定，在预期植入部位不能出现移位、早期脱落、更不可向上滑入肝脏胆管，支架固定的牢固程度对植入成功与否影响巨大，但由于金属弹性较差、硬度高容易划破组织，导致无法加工成弹簧片样式的卡扣结构，其固定结构以及加工工艺需要重新设计。此外当前载药技术无针对性，容易在植入早期被冲刷脱落或暴释而影响效果。
发明内容
本发明解决的技术问题是：现有镁金属支架不易固定、容易滑入肝内引起损伤以及强度低、柔顺性较差的技术问题。
为了达到上述目的，本发明提供了一种可定向降解自脱落镁金属胆道支架，包括管状的镁金属支架主体，所述支架主体的两端设有卡扣，所述支架主体设为螺旋形结构，制成所述两端卡扣的材料均设为可降解的高分子材料，制成所述两端卡扣的所述高分子材料的重均分子量不同。
优选地，所述支架主体的两端设有用于与所述卡扣连接的突起，所述卡扣上设有与所述突起相配合连接的孔。
优选地，所述卡扣上设有用于卡在胆道上的凸起的倒扣。
优选地，所述支架主体的一端卡扣设为用于植入后卡在胆道内部的头部卡扣；所述支架主体的另一端的卡扣设为用于植入后卡在胆道在十二指肠的出口的尾部卡扣，制成所述头部卡扣的所述高分子材料的重均分子量小于制成所述尾部卡扣的所述高分子材料的重均分子量；所述头部卡扣的降解周期设为7～180天，所述尾部卡扣的降解周期设为14～360天。
优选地，所述支架主体的外表面设有高分子涂层和/或药物层。
优选地，所述镁金属设为高纯镁、镁锌合金、镁钙合金、镁锌钙合金、镁稀土合金、镁锰合金、镁锶合金和镁铁合金中的一种；所述支架主体在人体内降解的周期为7～360天。
优选地，所述高分子材料设为聚乳酸、聚乙醇酸、乳酸-乙酸共聚物、聚对二氧环己酮和聚己内酯中的至少一种或其共聚体；所述高分子材料的重均分子量设为5000～1，000，000。
优选地，所述高分子涂层的孔隙率设为5％～80％，所述高分子涂层的材料设为聚乳酸、聚乙醇酸、乳酸-乙酸共聚物、聚对二氧环己酮和聚己内酯中的至少一种或其共聚体；所述高分子涂层的材料的重均分子量设为5000～100，000。
本发明还提供了所述的可定向降解自脱落镁金属胆道支架的制备方法，包括如下步骤：
步骤1：将镁金属材料经热挤压-冷轧加工为管材；
步骤2：将步骤1的管材在激光切割机上切割出螺旋形支架本体；
步骤3：将支架本体电解抛光，去除毛刺、活化表面；
步骤4：采用对应的高分子材料注塑出两端卡扣；
步骤5：将步骤4的两端卡扣和步骤3的支架本体组装成支架；
步骤6：辐照灭菌，制得可定向降解自脱落镁金属胆道支架。
优选地，所述步骤1中热挤压的温度为150～400℃，所述热挤压的减面率≥80％；所述冷轧的温度为5～40℃；所述步骤3中电解抛光的抛光液为磷酸-酒精溶液；所述电解抛光的电压为3～20V。
更优选地，所述磷酸-酒精溶液的质量浓度为5％～90％。
优选地，所述步骤2中激光切割的具体条件为：采用氩气保护，切割时对切割头吹气，及时吹走切割渣。
更优选地，所述氩气的流量≥10mL/min，。
优选地，在所述步骤6之前对所述步骤5的支架的外表面喷涂高分子涂层和/或药物层。
优选地，喷涂所述高分子涂层的溶液为高分子材料的四氢呋喃溶液，喷涂所述药物层的溶液为药物的四氢呋喃溶液。
更优选地，所述四氢呋喃溶液的浓度为1～20wt％。
相比现有技术，本发明具有如下有益效果：
1.本发明的一种可定向降解自脱落镁金属胆道支架，采用可脱落降解的镁金属作为支架主体，镁金属材料力学强度较高，支撑力较大；且具有良好的柔顺性，能够顺利通过ERCP系统和自然腔体弯曲管道；
2.本发明的一种可定向降解自脱落镁金属胆道支架，增加了两端卡扣设计，能够稳定固定在胆囊管内，保证在服役期内不脱落。
3.本发明的支架主体和两端卡扣采用不同的材料，保证植入后卡在胆道内的卡扣先降解，之后支架主体和卡在胆道在十二指肠出口的卡扣可以在胆管内被全部降解吸收，或者自脱落后能够随着蠕动滑入肠道排出体外，因此可避免卡在胆管出口的尾部卡扣先降解，从而防止胆道支架上行滑入肝内引起严重损伤。
4.本发明的胆道支架的外表面可载有抗结石药物，支撑后能够被直接吸收、增加抗结石效果。
附图说明
图1是本发明的一种可降解镁金属胆道支架的分解示意图；
图2是本发明的一种可降解镁金属胆道支架的卡扣的分解示意图；
图3是本发明的一种可降解镁金属胆道支架的整体结构示意图；
附图标记：1.尾部卡扣；2.螺旋形支架主体；3.头部卡扣；4.卡扣的倒扣；5.卡扣上与支架主体连接的孔；6.支架主体上与卡扣连接的突起；7.螺旋结构；8.螺旋缝隙。
具体实施方式
为使本发明更明显易懂，兹以优选实施例，并配合附图作详细说明如下。
实施例1
如图1所示，本发明的一种可定向降解自脱落镁金属胆道支架，包括螺旋形支架主体2、头部卡扣3和尾部卡扣1；头部卡扣3/尾部卡扣1与螺旋形支架主体2活动连接，头部卡扣3用于植入后卡在胆道内部，防止胆道支架脱落；尾部卡扣1用于植入后卡在胆道在十二指肠的出口，防止胆道向上滑入肝内引起严重的损伤。螺旋形支架主体2包括螺旋结构7和螺旋缝隙8，螺旋结构7为镁金属管材经雕刻加工(如激光雕刻)的螺旋槽而形成的，螺旋槽的宽度设为0.2～5mm，螺旋缝隙8的宽度设为0.5～10mm。螺旋形支架主体2的两端设有突起6，头部卡扣3/尾部卡扣1上设有与突起6相配合连接的孔5，头部卡扣3/尾部卡扣1上设有突起的倒扣4。螺旋形支架主体2的外表面设有高分子涂层，高分子涂层内可载覆抗结石药物或抗癌药物。高分子涂层选自聚乳酸、聚乙醇酸、乳酸-乙酸共聚物、聚对二氧环己酮和聚己内酯中的至少一种或其共聚体；其重均分子量为5000～10万，高分子涂层具有空隙，孔隙率为5％～80％。螺旋形支架主体2的长度设为10～200mm，外径设为2～10mm，壁厚设为0.1～2mm。
螺旋形支架主体2采用镁金属，镁金属设为高纯镁、镁锌合金、镁钙合金、镁锌钙合金、镁稀土合金、镁锰合金、镁锶合金和镁铁合金中的一种。镁金属材料强度较高，支撑力较好，螺旋形支架主体2在人体内完全降解的周期为7～360天；头部卡扣3和尾部卡扣1采用分子量不同的可降解吸收的高分子材料制成，制成头部卡扣3的高分子材料的分子量低于制成尾部卡扣1的高分子材料的分子量，高分子材料选自聚乳酸、聚乙醇酸、乳酸-乙酸共聚物、聚对二氧环己酮和聚己内酯中的至少一种或其共聚体；其重均分子量为5000～100万；头部卡扣3优先于尾部卡扣1降解，形成了异步降解。头部卡扣3的降解周期为7～180天，尾部卡扣1的降解周期为14～360天，尾部卡扣1的完全降解时间比头部卡扣3的完全降解时间长7～180天。这样可以保证胆道内头部卡扣1先降解，之后螺旋形支架主体2和尾部卡扣3可以在胆管内被全部降解吸收，或者降解后在胆管蠕动下排入肠道最终排出体外，因此可避免卡在胆管出口的尾部卡扣先降解，从而防止胆道支架上行滑入肝内引起严重损伤。既解决了永久支架存在的问题，又保证固定牢固、降解过程对机体安全，减少对胆道的机械损伤。
实施例2
一种可定向降解自脱落镁金属胆道支架的制备方法，包括如下步骤：
1.采用高纯镁管材作为原材料，热挤压为管材，温度150℃，缩面率80％，然后20℃冷轧至最终管材，管材外径3mm，壁厚0.2mm，长度60mm。
2.将上述镁管在氩气保护下激光切割出螺旋形结构的支架本体，其中螺旋槽宽0.2mm，螺旋间距1.5mm，氩气持续喷吹切割口，流量10mL/min。切割完成后，电解电压为3V的条件下，利用质量分数为20％的磷酸酒精溶液电解抛光，制得支架主体。
3.之后采用乳酸-乙酸共聚物(PLGA)注塑出头部卡扣和尾部卡扣，其中头部卡扣采用的PLGA的重均分子量为1万，尾部卡扣采用的PLGA的重均分子量为20万。
4.将头部卡扣、尾部卡扣与支架主体组装成支架后，穿入芯棒，保护内部表面，放于超声喷涂设备中，分别将2wt％的PLGA-四氢呋喃溶液及5wt％的熊去氧胆酸-四氢呋喃溶液超声喷涂于支架外表面，孔隙率60％。
5.辐照灭菌，制得可定向降解自脱落镁金属胆道支架。
在ERCP系统中将上述胆道支架植入猪胆总管后，头部卡扣卡在胆管内，尾部卡扣卡在胆管出口部位。头部卡扣降解时间30天，尾部卡扣降解时间大约50天。支架主体降解时间约30天，40天后降解后的胆道支架排入肠道。生物安全性良好。
实施例3
一种可定向降解自脱落镁金属胆道支架的制备方法，包括如下步骤：
1.采用Mg-2Zn合金，在300℃下挤压成管材，缩面率90％，然后30℃冷轧至最终管材，管材外径4mm，壁厚0.3mm，长度100mm。
2.将上述管材在氩气保护下激光切割出螺旋形结构的支架本体，其中螺旋槽宽0.1mm，螺旋间距3mm，氩气持续喷吹切割口，流量30mL/min。切割完成后，在电解电压为15v的条件下，利用45wt％的磷酸酒精溶液电解抛光，制得支架主体。
3.采用聚对二氧环己酮(PDO)注塑出头部和尾部的卡扣，其中头部卡扣采用的PDO的重均分子量为2万，尾部卡扣采用的PDO的重均分子量为10万。
4.将头部卡扣、尾部卡扣与支架主体组装成支架后，穿入芯棒，保护内部表面，放于超声喷涂设备中，将15wt％的PLGA-四氢呋喃溶液及5wt％的胆酸钠-四氢呋喃溶液超声喷涂于支架外表面，孔隙率60％。
5.辐照灭菌，制得可定向降解自脱落镁金属胆道支架。
在ERCP系统中将上述胆道支架植入猪胆总管后，头部卡扣卡在胆管内，尾部卡扣卡在胆管出口部位。头部卡扣降解时间20天，尾部卡扣降解时间大约30天。支架主体降解时间约20天，30天后降解后的胆道支架排入肠道。生物安全性良好。
以上所述，仅为本发明的较佳实施例，并非对本发明任何形式上和实质上的限制，应当指出，对于本技术领域的普通技术人员，在不脱离本发明的精神和范围的情况下，还将可以做出若干改进、补充、修饰与演变，这些也应视为本发明的保护范围。
Claims (11)
1.一种可定向降解自脱落镁金属胆道支架，其特征在于，包括管状的镁金属支架主体，所述支架主体的两端设有卡扣，所述支架主体设为螺旋形结构，制成所述两端卡扣的材料均设为可降解的高分子材料，制成所述两端卡扣的所述高分子材料的重均分子量不同；
所述支架主体的一端卡扣设为用于植入后卡在胆道内部的头部卡扣；所述支架主体的另一端的卡扣设为用于植入后卡在胆道位于十二指肠的出口的尾部卡扣，制成所述头部卡扣的所述高分子材料的重均分子量小于制成所述尾部卡扣的所述高分子材料的重均分子量；所述头部卡扣的降解周期设为7～180天，所述尾部卡扣的降解周期设为14～360天；所述尾部卡扣的完全降解时间比头部卡扣的完全降解时间长7～180天。
2.如权利要求1所述的可定向降解自脱落镁金属胆道支架，其特征在于，所述支架主体的两端设有用于与所述卡扣连接的突起，所述卡扣上设有与所述突起相配合连接的孔。
3.如权利要求1所述的可定向降解自脱落镁金属胆道支架，其特征在于，所述卡扣上设有用于卡在胆道上的凸起的倒扣。
4.如权利要求1所述的可定向降解自脱落镁金属胆道支架，其特征在于，所述支架主体的外表面设有高分子涂层和/或药物层。
5.如权利要求1所述的可定向降解自脱落镁金属胆道支架，其特征在于，所述镁金属设为高纯镁、镁锌合金、镁钙合金、镁锌钙合金、镁稀土合金、镁锰合金、镁锶合金和镁铁合金中的一种；所述支架主体在人体内降解的周期设为7～360天。
6.如权利要求1所述的可定向降解自脱落镁金属胆道支架，其特征在于，所述高分子材料设为聚乳酸、聚乙醇酸、乳酸-乙酸共聚物、聚对二氧环己酮和聚己内酯中的至少一种或其共聚体；所述高分子材料的重均分子量设为5000～1，000，000。
7.如权利要求4所述的可定向降解自脱落镁金属胆道支架，其特征在于，所述高分子涂层的孔隙率设为5％～80％，所述高分子涂层的材料设为聚乳酸、聚乙醇酸、乳酸-乙酸共聚物、聚对二氧环己酮和聚己内酯中的至少一种或其共聚体；所述高分子涂层的材料的重均分子量设为5000～100，000。
8.权利要求1～7中任意一项所述的可定向降解自脱落镁金属胆道支架的制备方法，包括如下步骤：
步骤1：将镁金属材料经热挤压-冷轧加工为管材；
步骤2：将步骤1的管材在激光切割机上切割出螺旋形支架本体；
步骤3：将支架本体电解抛光，去除毛刺、活化表面；
步骤4：采用对应的高分子材料注塑出两端卡扣；
步骤5：将步骤4的两端卡扣和步骤3的支架本体组装成支架；
步骤6：辐照灭菌，制得可定向降解自脱落镁金属胆道支架。
9.如权利要求8所述的可定向降解自脱落镁金属胆道支架的制备方法，其特征在于，所述步骤1中热挤压的温度为150～400℃，所述热挤压的减面率≥80％；所述冷轧的温度为5～40℃；所述步骤3中电解抛光的抛光液为磷酸-酒精溶液；所述电解抛光的电压为3～20V。
10.如权利要求8所述的可定向降解自脱落镁金属胆道支架的制备方法，其特征在于，在所述步骤6之前对所述步骤5的支架的外表面喷涂高分子涂层和/或药物层。
11.如权利要求10所述的可定向降解自脱落镁金属胆道支架的制备方法，其特征在于，喷涂所述高分子涂层的溶液为高分子材料的四氢呋喃溶液，喷涂所述药物层的溶液为药物的四氢呋喃溶液。
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