CN1021953C - 胶原-聚乙烯醇手术缝合线及其制作方法 - Google Patents
胶原-聚乙烯醇手术缝合线及其制作方法 Download PDFInfo
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Abstract
一种医用手术缝合线。它是以用酶消化法从哺乳动物结缔组织中提取的胶原蛋白和聚乙烯醇组成的复合溶液为基本原料，用高分子溶胀体成线装置挤入凝固浴中交联成型，再经络鞣制改性而得的单丝或复丝或其它形状的缝合材料。这种缝合材料克服了手术后组织反应大，不能吸收或脱落，有毒副作用，伤口愈合后瘢痕明显等诸多缺点，且制造本材料的原料易得，加工方便。
Description
本发明属于外科缝合材料。
至今国内外使用的外科手术缝合线有羊肠线，PDS缝线，VICRYL缝线，丝线，尼龙线和不锈钢缝合线。使用这些缝合线进行外科手术的缝合术后，有的不能自然吸收，需要拆线;有的组织反应大，伤口瘢痕明显;有的则吸收时间过长。国内较普遍使用的可吸收的羊肠线，是由羊肠内膜制成，在制作中易污染，造成肠线脆性较大。缝线长度受到肠材料长度的限制，故制品长度不能预先确定，再者，肠线的强度与动物的年龄等因素有关。而且，临床上曾有过手术后数月从体内排出羊肠线的病例。
本发明的目的在于以从哺乳动物的结缔组织中用酶消化法提取的天然胶原蛋白和聚乙烯醇（PVA）混匀的复合物为基本原料，制成一种新型医用外科缝合材料，以解决目前使用的各种缝合材料在手术后产生的上述缺点。本发明是将哺乳动物的结缔组织（如牛腱，牛皮，猪腱，猪皮）用浓度为0.1%的无花果蛋白酶（Ficin）溶液进行酶处理，再用双氧水（H2O2）溶液杀酶。将杀酶后的切片用0.3-0.5%的丙二酸溶液溶胀并搅拌混均，得到胶原蛋白。同时，将一定量的聚乙烯醇材料溶解于0.3%的丙二酸溶液中配成20%的PVA溶液。然后把配好的胶原蛋白与PVA溶液按一定比例混均，脱泡制得胶原-PVA溶液，将其装入高分子溶胀体成线装置用氮气挤压入由丙酮，氨水，甲醛和水组成的凝固浴中交联成型为单丝，或复丝，或其它任意所希望的形状，交联30分钟后，取出晾干。再把晾干的线束淹没于10-20%的三价铬溶液中鞣制1-2小时，再淹没于1%的碳酸钠溶液中定铬1小时，后取出冲洗至中性，凉干后封装于有二甲苯的安瓿内用γ射线照射灭菌而得成品。
经生物学实验和临床试用证明，本发明符合外科手术要求，具有组织反应轻，不必拆线，可自然吸收或脱落，无刺激性，伤口俞合后瘢痕小等诸多优点。另外制备本发明的原料容易获得，制品易按要求加工成所需形状和长度，又有一定的张力强度。
实例
将外购来的牛腱用水冲净，用剪刀剥去外表皮留下Y形部分。把Y形牛腱逐根用手术剪和单面刀片刮去表面筋膜，脂肪和其它杂质，去掉“V”段，留下“I”段置于冰箱中冷冻后，纵向切成1-2mm厚度的腱片。称取500g牛腱片用蒸馏水冲洗3次，滗干，然后加入0.1%的Ficin 4.8g，EDTA-2Na 1.16g，EDTA-4Na 0.62g，H2O 4800ml，置于37℃左右的培养箱中培养16小时，取出用蒸馏水冲洗3次后加入H2O约4000ml，H2O210ml杀酶20分钟。杀酶后的腱片用蒸馏水冲洗3-4次，滗干，加入0.5%的丙二酸溶液10000ml溶胀24小时。把溶胀后的腱片用食品搅拌机充分搅拌6小时，同时加入0.3%丙二酸约2000-6000ml以调节粘度，然后用80-120目不锈钢网过滤，除去杂质和不溶胀物。称适量聚乙烯醇，加入0.3%的丙二酸溶液在60℃水浴中使其完全溶解，配成固体含量为20%的PVA溶液，用80-120目不锈钢网过滤除去杂质。将上述两种滤液按胶原∶PVA＝80∶20的比例混合，用高速搅拌机混匀，用3000rpm的离心机离心15分钟除去气泡，得到纺丝原液。把纺丝原液装入高分子溶胀
体成线装置中，用0.2kg/cm2压力氮气将其挤入由10%丙酮，4%氨水，1.4%甲醛，84.6%水组成的凝固浴中成型交联30分钟，然后取出线束在架上凉干。把凉干的线束浸入20%的硫酸铬中鞣制1小时后再浸入1%的碳酸钠溶液中定铬1小时，或用在酸性条件下的醛类处理1小时，然后取出用蒸馏水洗至中性，绷紧在特制架子上于室温下凉干，封装入有二甲苯的安瓿中，用剂量为260万拉德的γ射线照射灭菌制得产品。
Claims (6)
1、一种医用手术缝合线，其特征在于，该缝合线是以天然胶原蛋白与聚乙烯醇的复合物为原料制成的。
2、根据权利要求1制成的缝合线，其特征在于，该缝合线可以是单丝或复丝的。
3、一种以天然胶原蛋白和聚乙烯醇为原料生产医用缝合线的方法，该方法包括用酶消化法从动物的结缔组织中提取的胶原蛋白，经用0.3-0.5%丙二酸溶胀后与聚乙烯醇在0.3%丙二酸中制成的20%聚乙烯醇溶液按80∶20（重量比）的比例混均以得到纺丝原液，然后将此纺丝原液高压挤入凝固浴中交联成型30分钟。
4、根据权利要求3的方法，其中所说的酶消化法是使用浓度为0.1%（W/V）的无花果蛋白酶。
5、根据权利要求3的方法，其中所说的凝固浴的组成及其重量比例为丙酮∶氨水∶甲醛∶水＝10∶4∶1.4∶84.6。
6、根据权利要求3的方法，其中该方法还包括对成型品作进一步的铬鞣制和定铬处理。
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 89108465 CN1021953C (zh) | 1989-11-08 | 1989-11-08 | 胶原-聚乙烯醇手术缝合线及其制作方法 |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 89108465 CN1021953C (zh) | 1989-11-08 | 1989-11-08 | 胶原-聚乙烯醇手术缝合线及其制作方法 |
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| Publication Number | Publication Date |
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| CN1051510A CN1051510A (zh) | 1991-05-22 |
| CN1021953C true CN1021953C (zh) | 1993-09-01 |
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| CN 89108465 Expired - Fee Related CN1021953C (zh) | 1989-11-08 | 1989-11-08 | 胶原-聚乙烯醇手术缝合线及其制作方法 |
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1086145C (zh) * | 1994-12-08 | 2002-06-12 | 中国医学科学院生物医学工程研究所 | 组织引导再生胶原膜及其制造方法 |
| CN1065773C (zh) * | 1994-12-28 | 2001-05-16 | 天津纺织工学院膜天膜技术工程公司 | 医用可吸收生物材料柔性缝合线 |
| CN1058904C (zh) * | 1995-04-11 | 2000-11-29 | 曾家修 | 哺乳动物肌腱组织医用缝合线 |
| PL1966417T3 (pl) * | 2005-12-22 | 2017-02-28 | Dsm Ip Assets B.V. | Wyrób do napraw chirurgicznych zawierający włókna UHMWPE |
| CN104383592A (zh) * | 2014-11-25 | 2015-03-04 | 苏州市贝克生物科技有限公司 | 一种聚乙烯醇类医用可吸收缝合线及其制备方法 |
| KR102056302B1 (ko) * | 2016-03-24 | 2019-12-16 | 주식회사 엘지화학 | 고흡수성 수지 섬유의 제조 방법 |
| CN108774884B (zh) * | 2018-06-22 | 2021-04-30 | 高娟 | 能量细胞线及多维立体综合提升术 |
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1989
- 1989-11-08 CN CN 89108465 patent/CN1021953C/zh not_active Expired - Fee Related
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| CN1051510A (zh) | 1991-05-22 |
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