CN112120753A - 一种可吸收高分子止血夹 - Google Patents
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Abstract
本发明公开了一种可吸收高分子止血夹,该止血夹包括外层夹(1)和内层夹(2),所述外层夹(1)和内层夹(2)均为“U”型开口结构,所述外层夹(1)和内层夹(2)上均设有防滑脱接头,所述防滑脱接头包括设置于外层夹内侧平面的卡槽(3)及设置于所述内层夹外侧平面上与所述卡槽相适配的导条(4),所述卡槽(3)为榫卯式楔形卡槽,所述导条(4)为榫卯式楔形导条,所述卡槽(3)与导条(4)呈楔形榫卯式连接。本发明结构简单精巧,结构牢固,解决了现有腹腔镜用一次性止血钛夹在人体内无法降解的问题,不会干扰射线检查使止血夹夹闭区域组织的诊断失真。
Description
技术领域
本发明涉及腹腔镜微创手术医用耗材技术领域,具体涉及一种可吸收高分子止血夹。
背景技术
腹腔镜手术是一种微创手术,与传统的手术相比,腹腔镜手术医生无法接触到手术部位,血管止血显得尤为重要,临床上通常采用止血夹来夹闭破裂的血管。目前市场上使用最广泛的止血夹是金属钛止血夹,此类为金属止血夹,生产成本很低,稳定性好。但是金属钛夹的使用也给病人带来了隐患,一方面钛对X射线的吸收能力要远高于人体组织,会干扰射线检查使止血夹夹闭区域组织的诊断失真,另一方面金属钛夹在人体内不可降解,长期存在可能会产生炎症,此外随着血管伤口的愈合,金属夹可能会掉落游走至人体其他部位,存在安全造成隐患。
美国专利US7326223公开了一种V型高分子止血夹的结构,与钛夹相比高分子止血夹不会出现显影干扰的情况且柔顺性更好。目前国内市场上生产的大多数高分子止血夹结构与其类似均为V型结构,使用材料大部分为不可降解的惰性聚甲醛POM材料,高分子止血夹比但是在使用中仍然存在一些问题:V型夹锁合处的钩子在手术操作时候很容易勾到人体组织,造成止血夹夹闭困难。此外材料长期存在体内会造成炎症。杭州圣石公司生产了一种双层结构的可吸收止血夹,该止血夹由内层夹和外层夹组成,内层夹材料采用聚对二氧环己酮,外层夹材料采用聚乙交酯,使用时借助于施夹器进行操作,内层夹开有方形或圆形的孔,与外层的钩锁对接,但是在实际操作过程中有时候会出现圆孔和外钩滑脱的情况,会损伤到人体组织,且降解时间不可控。
发明内容
本发明的目的是为了解决上述现有技术中存在的不足,提供了一种可吸收高分子止血夹,结构简单精巧,结构牢固,解决了现有腹腔镜用一次性止血钛夹在人体内无法降解的问题,不会干扰射线检查使止血夹夹闭区域组织的诊断失真。
为了达到上述发明目的,本发明提供的技术方案如下:一种可吸收高分子止血夹,该止血夹包括外层夹和内层夹,所述外层夹和内层夹均为“U”型开口结构,所述外层夹和内层夹上均设有防滑脱接头,所述防滑脱接头包括设置于外层夹内侧平面的卡槽及设置于所述内层夹外侧平面上与所述卡槽相适配的导条,所述卡槽为榫卯式楔形卡槽,所述导条为榫卯式楔形导条,所述卡槽与导条呈楔形榫卯式连接,所述内层夹一端部设置有卡扣件,所述外层夹一端内侧设置有与卡扣件适配连接的凹槽,止血夹夹闭后,内层夹一端部的卡扣件与外层夹一端内侧的凹槽通过卡合固定连接。
所述止血夹的制备方法,包括如下步骤:
S1.原料的制备
(a)聚乙交酯的制备:
在真空或者高压条件下,设置反应温度120-180℃,取一定量乙交酯于反应釜中,加入0.01-0.05%质量浓度的辛酸亚锡催化剂,反应时间5-7h,然后回流提纯、造粒,即得聚乙交酯,放于冰箱内低温密封保存;
(b)聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物的制备:
在真空或者高压条件下,设置反应温度110-200℃,取一定量乙交酯、三亚甲基碳酸酯、对二氧环己酮于反应釜中,加入0.01-0.05%质量浓度的辛酸亚锡催化剂,乙交酯:三亚甲基碳酸酯:对二氧环己酮的重量比为(15:5:80)-(10:80:10),反应时间3-7h,然后回流提纯、造粒,即得聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物产物,密封保存;
S2.成型工艺:
所述外层夹由聚乙交酯制成,所述内层夹由聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物制成;所述外层夹和内层夹采用注塑或者模压成型;
所述模压成型温度为210-225℃;
所述注塑成型条件为模具预热温度50-70℃、注塑温度190-210℃、注塑周期25-35s,随后对所述注塑成型的可吸收高分子止血夹进行热处理;
S3.灭菌、包装。
作为优选地,所述导条楔形结构的夹角范围为15-75°。
作为优选地,所述内层夹夹闭后的外宽等于外层夹的内宽。
作为优选地,所述导条的长度小于或等于卡槽的长度。
作为优选地,所述外层夹采用的聚乙交酯分子量为10000-1000000。
作为优选地,所述内层夹采用的聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物分子量为10000-2000000。
作为优选地,所述止血夹的降解周期为6-24个月。
基于上述技术方案,本发明的与现有技术相比具有如下技术优点:
本发明中的聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物是一类新型高分子聚合材料,具有优良的生物相容性和降解性,同时其结构单元中含有醚键,具有很高的强度和良好的韧性,在人体内最终完全分解成二氧化碳和水,医疗临床应用无毒无害,可应用于腹腔镜微创手术医用耗材领域。
本发明结构简单精巧,结构牢固,利用卡扣件与凹槽配合,当止血夹夹闭后,内层夹一端部的卡扣件与外层夹一端内侧的凹槽通过卡合固定连接,固定效果更好,避免了止血夹在血管内滑脱,有利于对人体内管状组织或其它腔内组织的夹紧,安全性更高;外层夹和内层夹上均设有防滑脱接头,防滑脱接头包括设置于外层夹内侧平面的卡槽及设置于内层夹外侧平面上与卡槽相适配的导条,导条为榫卯式楔形导条,卡槽与导条呈楔形榫卯式连接,利用导条及卡槽的相互配合在轴向上起到导向功能,同时在径向上起到限位作用;该止血夹外层夹采用聚乙交酯,内层夹采用聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物,通过调控不同的单体比例来控制降解速率,尤其是通过控制乙交酯:三亚甲基碳酸酯:对二氧环己酮的重量比为(15:5:80)-(10:80:10)制备而成的聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物,可以更好地使得止血夹在人体内按一定的周期降解,能够解决腹腔镜用一次性止血钛夹在人体内无法降解的问题。
附图说明
图1为本发明止血夹的结构示意图。
图2为本发明止血夹夹闭后的状态示意图。
图3为图2中A-A处的剖面图。
图中:1.外层夹,2.内层夹,3.卡槽,4.导条,5.卡扣件,6.凹槽。
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解释说明。
如图1-图3所示,一种可吸收高分子止血夹,该止血夹包括外层夹1和内层夹2,所述外层夹1和内层夹2均为“U”型开口结构,所述外层夹1和内层夹2上均设有防滑脱接头,所述防滑脱接头包括设置于外层夹内侧平面的卡槽3及设置于所述内层夹外侧平面上与所述卡槽相适配的导条4,所述卡槽3为榫卯式楔形卡槽,所述导条4为榫卯式楔形导条,所述卡槽3与导条4呈楔形榫卯式连接,所述内层夹2一端部设置有卡扣件5,所述外层夹1一端内侧设置有与卡扣件5适配连接的凹槽6,止血夹夹闭后,内层夹一端部的卡扣件5与外层夹一端内侧的凹槽6通过卡合固定连接。
所述止血夹的制备方法,包括如下步骤:
S1.原料的制备
(a)聚乙交酯的制备:
在真空或者高压条件下,设置反应温度120-180℃,取一定量乙交酯于反应釜中,加入0.01-0.05%质量浓度的辛酸亚锡催化剂,反应时间5-7h,然后回流提纯、造粒,即得聚乙交酯,放于冰箱内低温密封保存;
(b)聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物的制备:
在真空或者高压条件下,设置反应温度110-200℃,取一定量乙交酯、三亚甲基碳酸酯、对二氧环己酮于反应釜中,加入0.01-0.05%质量浓度的辛酸亚锡催化剂,乙交酯:三亚甲基碳酸酯:对二氧环己酮的重量比为(15:5:80)-(10:80:10),反应时间3-7h,然后回流提纯、造粒,即得聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物产物,密封保存;
S2.成型工艺:
所述外层夹1由聚乙交酯制成,所述内层夹2由聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物制成;所述外层夹1和内层夹2采用注塑或者模压成型;
所述模压成型温度为210-225℃;
所述注塑成型条件为模具预热温度50-70℃、注塑温度190-210℃、注塑周期25-35s,随后对所述注塑成型的可吸收高分子止血夹进行热处理;
S3.灭菌、包装。
所述S3中的灭菌方式为环氧乙烷灭菌。
所述导条4楔形结构的夹角范围为15-75°。所述内层夹2夹闭后的外宽等于外层夹1的内宽。所述导条4的长度小于或等于卡槽3的长度。所述外层夹1采用的聚乙交酯分子量为10000-1000000。所述内层夹2采用的聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物分子量为10000-2000000。所述止血夹的降解周期为6-24个月。
实施例1
聚乙交酯的制备:取200g乙交酯于反应釜中,加入0.01%质量浓度的辛酸亚锡催化剂,再加入一定量的丙酮调节体系粘度,在真空条件下,反应温度设置 170℃,反应6h得到聚乙交酯产物。将聚乙交酯产物加入挤塑机,挤出温度150℃得到粒径为1.5-2mm、长为3mm大小的聚乙交酯颗粒。将聚乙交酯颗粒在40℃下真空干燥24小时。利用熔融指数仪设置测试条件为230℃/2.16kg,采用ASTMD-1238标准测定聚乙交酯的熔融指数为50g/10min。
将上述制备的聚乙交酯通过本发明的注塑工艺加工成止血夹外层夹,经测试外层夹的拉伸强度为70MPa,分子量为300000。
在反应釜中加入300g乙交酯、三亚甲基碳酸酯、对二氧环己酮(按重量比为20:10:70),加入0.05%质量浓度的辛酸亚锡催化剂,反应温度135℃,通氮气保护,反应时间7h,然后回流提纯,在170℃下将得到的聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物产物加入到挤塑机中,得到粒径为1.5-2mm,长为3mm大小的颗粒,称重得到粒料260g,收率87%,将上述粒料溶解在六氟异丙醇溶液中,用乌氏粘度计在25℃恒温水浴中测得聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物的特性粘数为3.62dL/g。
将上述制备的聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物通过本发明的注塑工艺加工成止血夹内层夹。
实施例2
聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物的制备:在反应釜中加入300g乙交酯、三亚甲基碳酸酯、对二氧环己酮(按重量比为15:25:60),加入0.05%质量浓度的辛酸亚锡催化剂,反应温度135℃,通氮气保护,反应时间6h,然后回流提纯,在170℃下将得到的聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物产物加入到挤塑机中,得到粒径为1.5-2mm,长为3mm大小的颗粒,称重得到粒料280g,收率93%,将上述粒料溶解在六氟异丙醇溶液中,用乌氏粘度计在25℃恒温水浴中测得聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物的特性粘数为3.60dL/g。
将上述制备的聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物通过本发明的注塑工艺加工成止血夹内层夹,经测试内层夹的拉伸强度为60MPa,分子量为680000。
实施例3
聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物的制备:在反应釜中加入300g乙交酯、三亚甲基碳酸酯、对二氧环己酮(按重量比为30:40:30),加入0.1%质量浓度的辛酸亚锡催化剂,反应温度140℃,通氮气保护,反应时间8h,然后回流提纯,在170℃下将得到的聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物产物加入到挤塑机中,得到粒径为1.5-2mm,长为3mm大小的颗粒,称重得到粒料270g,收率90%,将上述粒料溶解在六氟异丙醇溶液中,用乌氏粘度计在25℃恒温水浴中测得聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物的特性粘数为3.93dL/g。
将上述制备的聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物通过本发明的注塑工艺加工成止血夹内层夹,经测试内层夹的拉伸强度为75MPa,分子量为500000。
实施例4
聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物的制备:在反应釜中加入300g乙交酯、三亚甲基碳酸酯、对二氧环己酮(按重量比为38:12:50),加入0.1%质量浓度的辛酸亚锡催化剂,反应温度155℃,通氮气保护,反应时间8h,然后回流提纯,在170℃下将得到的聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物产物加入到挤塑机中,得到粒径为1.5-2mm,长为3mm大小的颗粒,称重得到粒料250g,收率83.3%,将上述粒料溶解在六氟异丙醇溶液中,用乌氏粘度计在25℃恒温水浴中测得聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物的特性粘数为4.38dL/g。
将上述制备的聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物通过本发明的注塑工艺加工成止血夹内层夹。
实施例5
聚乙交酯-聚己内酯-聚对二氧环己酮共聚物的制备:将乙交酯、己内酯、对二氧环己酮(按重量比为38:22:40)置于反应器中,加入0.03%的辛酸亚锡催化剂,通氮气保护、在真空条件、155℃下反应11小时,在130℃下将得到的聚乙交酯-己内酯-对二氧环己酮共聚物产物加入挤塑机得到直径1-2mm,长5mm的颗粒,将以上粒料在60℃下真空干燥8小时,以六氟异丙醇作为溶剂,用乌氏粘度计在25℃恒温水浴中,测得聚乙交酯-聚己内酯-聚对二氧环己酮共聚物的特性粘度为4.16dl/g。
将上述制备的聚乙交酯-聚己内酯-聚对二氧环己酮共聚物通过本发明的注塑工艺加工成止血夹内层夹,经测试内层夹的拉伸强度为85MPa,分子量为80000。
实施例6
聚乙交酯-聚丙交酯-聚对二氧环己酮共聚物的制备:将乙交酯、丙交酯、对二氧环己酮(按重量比为30:17:53)置于反应器中,加入0.03%的辛酸亚锡催化剂,通氮气保护、在真空条件、140℃下反应11小时,在140℃下将得到的聚乙交酯-丙交酯-对二氧环己酮共聚物产物加入挤塑机得到直径1-2mm,长8mm的颗粒,将以上粒料在60℃下真空干燥8小时,以六氟异丙醇作为溶剂,用乌氏粘度计在25℃恒温水浴中,测得聚乙交酯-聚丙交酯-聚对二氧环己酮共聚物的特性粘度为4.34dl/g,经测试内层夹的拉伸强度为70MPa,分子量50000。
将上述制备的聚乙交酯-聚丙交酯-聚对二氧环己酮共聚物通过本发明的注塑工艺加工成止血夹内层夹。
上述内容为本发明的示例及说明,但不意味着本发明可取得的优点受此限制,凡是本发明实践过程中可能对结构的简单变换、和/或一些实施方式中实现的优点的其中一个或多个均在本申请的保护范围内。
Claims (8)
1.一种可吸收高分子止血夹,其特征在于:该止血夹包括外层夹(1)和内层夹(2),所述外层夹(1)和内层夹(2)均为“U”型开口结构,所述外层夹(1)和内层夹(2)上均设有防滑脱接头,所述防滑脱接头包括设置于外层夹内侧平面的卡槽(3)及设置于所述内层夹外侧平面上与所述卡槽相适配的导条(4),所述卡槽(3)为榫卯式楔形卡槽,所述导条(4)为榫卯式楔形导条,所述卡槽(3)与导条(4)呈楔形榫卯式连接,所述内层夹(2)一端部设置有卡扣件(5),所述外层夹(1)一端内侧设置有与卡扣件(5)适配连接的凹槽(6),止血夹夹闭后,内层夹一端部的卡扣件(5)与外层夹一端内侧的凹槽(6)通过卡合固定连接。
2.根据权利要求1所述的可吸收高分子止血夹,其特征在于:所述止血夹的制备方法,包括如下步骤:
S1.原料的制备
(a)聚乙交酯的制备:
在真空或者高压条件下,设置反应温度120-180℃,取一定量乙交酯于反应釜中,加入0.01-0.05%质量浓度的辛酸亚锡催化剂,反应时间5-7h,然后回流提纯、造粒,即得聚乙交酯,放于冰箱内低温密封保存;
(b)聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物的制备:
在真空或者高压条件下,设置反应温度110-200℃,取一定量乙交酯、三亚甲基碳酸酯、对二氧环己酮于反应釜中,加入0.01-0.05%质量浓度的辛酸亚锡催化剂,乙交酯:三亚甲基碳酸酯:对二氧环己酮的重量比为(15:5:80)-(10:80:10),反应时间3-7h,然后回流提纯、造粒,即得聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物产物,密封保存;
S2.成型工艺:
所述外层夹(1)由聚乙交酯制成,所述内层夹(2)由聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物制成;所述外层夹(1)和内层夹(2)采用注塑或者模压成型;
所述模压成型温度为210-225℃;
所述注塑成型条件为模具预热温度50-70℃、注塑温度190-210℃、注塑周期25-35s,随后对所述注塑成型的可吸收高分子止血夹进行热处理;
S3.灭菌、包装。
3.根据权利要求1所述的可吸收高分子止血夹,其特征在于:所述导条(4)楔形结构的夹角范围为15-75°。
4.根据权利要求1所述的可吸收高分子止血夹,其特征在于:所述内层夹(2)夹闭后的外宽等于外层夹(1)的内宽。
5.根据权利要求1所述的可吸收高分子止血夹,其特征在于:所述导条(4)的长度小于或等于卡槽(3)的长度。
6.根据权利要求1所述的可吸收高分子止血夹,其特征在于:所述外层夹(1)采用的聚乙交酯分子量为10000-1000000。
7.根据权利要求1所述的可吸收高分子止血夹,其特征在于:所述内层夹(2)采用的聚乙交酯-聚三亚甲基碳酸酯-聚对二氧环己酮共聚物分子量为10000-2000000。
8.根据权利要求1所述的可吸收高分子止血夹,其特征在于:所述止血夹的降解周期为6-24个月。
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CN117982740A (zh) * | 2024-04-07 | 2024-05-07 | 四川国纳科技有限公司 | 可吸收生物医用高分子材料、结扎夹及制备方法 |
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CN114767947B (zh) * | 2022-05-05 | 2023-02-14 | 暨南大学 | 一种聚酯类复合材料可吸收血管夹及其制备方法 |
CN117982740A (zh) * | 2024-04-07 | 2024-05-07 | 四川国纳科技有限公司 | 可吸收生物医用高分子材料、结扎夹及制备方法 |
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