CN1907234A - 带生物膜的血管瘤夹 - Google Patents
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- A61B2017/00831—Material properties
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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Abstract
本发明公开了一种带生物膜的血管瘤夹，它由金属夹和生物膜(3)组成，其中金属夹是由医用不锈钢或钛合金制成，其结构包括尾部通过弹性装置(7)相连的相互交叉搭接的第一夹杆(5)和第二夹杆(6)，在第一夹杆(5)上的半套环(8)和第二夹杆(6)上的半套环(9)的末端各自设有第一夹臂(1)和第二夹臂(2)，生物膜(3)的两端分别固定在所述第一夹臂(1)和第二夹臂(2)上，形成膜套。本发明的优点是：这种带生物膜的血管瘤夹带有具有良好生物相容性的生物膜，可将所夹部位的血管外周包裹起来，防止血管瘤进一步恶化，并可与血管外壁长合在一起，起到生物化的增厚及加固保护作用，治疗效果好，使用安全可靠。
Description
技术领域
本发明涉及一种血管瘤夹，它是用于治疗血管瘤的装置，属植入人体内的医疗器械。
背景技术
血管瘤尤其动脉瘤是常见的血管病之一，血管瘤的治疗方法有多种，对于某些形态的血管瘤，用血管夹将瘤囊从根部(与血管壁平行的方位)夹死，令瘤囊关闭，是一种简便的治疗方法，特别适用于那些难于暴露的部位，这一种方法已经在临床应用多时，短期效果良好。但由于形成血管瘤时，其于轴向垂直的另一侧血管壁也被拉薄，关闭瘤囊一侧后另一侧也有可能进一步变薄而形成新的瘤囊，治疗效果不理想；对于梭形血管瘤，普通的血管瘤夹更是无能为力。
发明内容
本发明的目的是提供一种新型的带生物膜的血管瘤夹，这种带生物膜的血管瘤夹带有坚韧的生物膜，它可将所夹部位的血管外周包裹起来，对防止该部位进一步瘤变及防止瘤囊破裂有显著作用，可大大提高治疗效果。
本发明的另一目的是提供上述带生物膜的血管瘤夹的制备方法。
本发明的技术解决方案是：带生物膜的血管瘤夹，它由金属夹和生物膜组成，其中金属夹是用医用不锈钢或钛合金制成，其结构包括尾部通过弹性装置相连的相互交叉搭接的第一夹杆和第二夹杆，在第一夹杆上的半套环和第二夹杆上的半套环的末端各自设有第一夹臂和第二夹臂，生物膜的两端分别固定在所述第一夹臂和第二夹臂上，形成膜套。
所述的生物膜是是由猪、牛或羊的横膈膜、脂肪网膜、心包膜或肠膜经交联固定和去抗原处理后所形成的膜，这样的原料取材容易，成本较低，有利于推广应用。
动物组织易被微生物降解或分解，传统上用醛类(甲醛、戊二醛等)与之交联固定来提高其稳定性；但醛类是靠缩醛反应与蛋白质交联的，其交联产物降解时会释放出有毒的醛，使得用醛固定的制品有长期残留毒性。当应用非醛类固定剂，如环氧化物、二酰二胺、二异氰酸酯或碳化二亚胺时，就没有这一缺点，以环氧化物为例，由于环氧化物是靠开环反应来交联蛋白质分子的，开环后不能再轻易形成环氧化物，其降解产物是可被机体代谢的多元醇，无醛类的残留毒性，处理后的动物组织的稳定性也比用醛类固定的高；根据现代免疫学理论，动物组织的抗原性主要是由蛋白质中某些特殊位置的活性基团及特异构象引起的，这些活性基团主要有-OH，-NH2，-SH等，而特异构象通常是由于蛋白质分子螺旋链的某些特殊氢键引起，在处理动物膜组织时，用一种或多种易与这些活性基团起反应的活泼试剂(如酸酐、酰氯、酰胺、环氧化物等)与这些基团结合，将其封闭起来，从而去除其抗原，同时，还应用强氢键试剂(如胍类化合物)，置换引起特异构象的氢键，改变其构象，进一步消除其抗原性。动物膜组织经环氧化物交联固定后，其组织不易被微生物降解或分解，再通过封闭蛋白质中的活性基团和改变其构象，有效的去除其免疫抗原性，所形成的生物膜无残留毒性，无慢性免疫排异反应，具有良好的生物相容性，这种带生物膜的血管瘤夹在使用时，可以将所夹部位的血管外周包裹起来，生物膜还可与血管外膜生长在一起，从而起到生物加固作用，起到很好的治疗效果。
作为一种优化方案，在使用动物坚韧组织制得的生物膜的表面上偶联有可粘附生长因子的特定多肽或糖胺聚糖类活性组分的活性表面层。所述的特定多肽之一是由16个赖氨酸(K16)、甘氨酸(G)、精氨酸(R)、天冬氨酸(D)、丝氨酸(S)、脯氨酸(P)及半胱氨酸(C)缩聚而成的，所述的糖胺聚糖是透明质酸、硫酸软骨素、硫酸皮肤素、肝素、硫酸乙酰肝素或硫酸角质素。这些活性组分有利于所包裹的血管壁细胞长入并与血管壁组织融合在一起，起到生物加固作用。
所述生物膜的长度与相对应的由所述半套环所形成的套环的周长相等。
带生物膜的血管瘤夹的制备方法，其中所述的生物膜是以天然的动物坚韧膜组织为原料，按以下步骤制备：
1、预处理：使用广谱灭菌剂进行初步灭菌后修剪去除多余组织；
2、交联固定：使用固定剂交联固定膜材中的蛋白质分子；
3、去除抗原：使用活泼试剂封闭膜材蛋白质中特殊位置的活性基团如-OH，-NH2，-SH等，并用强氢键试剂置换膜材蛋白质分子螺旋链中的特殊氢键；
最后将得到的生物膜的两端分别用医用胶粘剂固定在金属夹的夹臂上。
作为一种优化方案，带生物膜的血管瘤夹的制备方法中还包括在生物膜的表面通过偶联剂偶联含有特定多肽或糖胺聚糖类活性组分形成活性表面层的步骤。
带生物膜的血管瘤夹的制备方法中所述的固定剂为易与蛋白质分子发生交联反应的环氧化物、二酰二胺、二异氰酸酯或碳化二亚胺中的一种或两种试剂，以环氧化物为好，所述的环氧化物可以是单环氧化物
也可以是双环氧化物
这里R＝CnH2n+1-，n＝0-10。
带生物膜的血管瘤夹的制备方法中所述的活泼试剂可以是小分子有机酸酐、酰氯、酰胺、单环氧化物等，强氢键试剂为胍类化合物。
带生物膜的血管瘤夹的制备方法中偶联含有特定多肽或糖胺聚糖类活性组分形成活性表面层所用的偶联剂可用二酰二胺或二酸酐或双环氧化物或它能与-NH2，-OH，-COOH等起缩合反应的双官能团试剂。
本发明的优点是：这种带生物膜的血管瘤夹带有具有良好的生物相容性的生物膜，可将所夹部位的血管外周包裹起来，可阻止血管瘤进一步恶化，并可与血管外壁长合在一起，起到生物化的增厚及加固作用，治疗效果好，使用安全可靠。
附图说明
附图1为本发明实施例的结构示意图；
附图2为本发明实施例中A部放大图；
1、第一夹臂，2、第二夹臂，3、生物膜，4、活性表面层，5、第一夹杆，6、第二夹杆，7、弹性装置，8、半套环，9、半套环，10、套环。
具体实施方式
实施例：如附图1和2所示，带生物膜的血管瘤夹，它由金属夹和生物膜3组成，其中金属夹包括尾部通过弹性装置7相连的相互交叉搭接的第一夹杆5和第二夹杆6，在第一夹杆5上的半套环8和第二夹杆6上的半套环9的末端各自设有第一夹臂1和第二夹臂2，生物膜3的两端分别固定在所述第一夹臂1和第二夹臂2上，形成膜套。所述生物膜3的长度与相对应的由所述半套环8和所述半套环9所形成的套环10的周长相等，其宽度与夹臂的臂长相同或两端各长出1-2mm。所述的生物膜3的表面上含有偶联可粘附生长因子的特定多肽或糖胺聚糖类活性组分形成的活性表面层4。所述的特定多肽是由16个赖氨酸(K16)、甘氨酸(G)、精氨酸(R)、天冬氨酸(D)、丝氨酸(S)、脯氨酸(P)及半胱氨酸(C)缩聚而成的，所述的糖胺聚糖是透明质酸、硫酸软骨素、硫酸皮肤素、肝素、硫酸乙酰肝素或硫酸角质素。所述的生物膜3为猪、牛或羊的横膈膜、脂肪网膜、心包膜或肠膜经环氧化物交联固定和去抗原处理后所形成的膜。金属夹是以医用不锈钢或肽合金制成。
带生物膜的血管瘤夹的制备方法，其生物膜3是以天然的动物坚韧膜组织为原料，采取以下步骤制备：
①、预处理：使用广谱灭菌剂进行初步灭菌后修剪去除多余组织；
②、交联固定：使用固定剂交联生物膜3中的蛋白质分子，使稳定；
③、去除抗原：使用活泼试剂封闭生物膜3蛋白质中特殊位置的活性基团-OH或-NH2或-SH，并用强氢键试剂置换生物膜3蛋白质分子螺旋链中的特殊氢键；
④、在生物膜3的表面上通过偶联剂偶联含有特定多肽或糖胺聚糖类活性组分形成活性表面层4。
最后将得到的生物膜3的两端分别用医用胶粘剂固定在金属夹的所述第一夹臂1、第二夹臂2上，即可制得本发明的产品。
所述的固定剂为易与蛋白质分子发生交联反应的环氧化物、二酰二胺、二异氰酸酯或碳化二亚胺中的一种或两种试剂，所述的环氧化物可以是单环氧化物
也可以是双环氧化物
这里R＝CnH2n+1-，n＝0-10。
所述的活泼试剂可以是小分子有机酸酐、酰氯、酰胺、单环氧化物等，强氢键试剂为胍类化合物。
所述的偶联剂可用二酰二胺或二酸酐或双环氧化物或其它能与-NH2，-OH，-COOH等起缩合反应的双官能团试剂。
Claims (11)
1、一种带生物膜的带生物膜的血管瘤夹，其特征在于：它由金属夹和生物膜(3)组成，其中金属夹是由医用不锈钢或钛合金制成，其结构包括尾部通过弹性装置(7)相连的相互交叉搭接的第一夹杆(5)和第二夹杆(6)，在第一夹杆(5)上的半套环(8)和第二夹杆(6)上的半套环(9)的末端各自设有第一夹臂(1)和第二夹臂(2)，生物膜(3)的两端分别固定在所述第一夹臂(1)和第二夹臂(2)上，形成膜套。
2、根据权利要求1所述的带生物膜的血管瘤夹，其特征在于：所述的生物膜(3)是由猪、牛或羊的横膈膜、脂肪网膜、心包膜或肠膜经交联固定和去抗原处理后所形成的膜。
3、根据权利要求1所述的带生物膜的血管瘤夹，其特征在于：在所述生物膜(3)的表面上偶联有可粘附生长因子的特定多肽或糖胺聚糖类活性组分的活性表面层(4)。
4、根据权利要求3所述的带生物膜的血管瘤夹，其特征在于：所述的特定多肽之一是由16个赖氨酸(K16)、甘氨酸(G)、精氨酸(R)、天冬氨酸(D)、丝氨酸(S)、脯氨酸(P)及半胱氨酸(C)缩聚而成的，所述的糖胺聚糖是透明质酸、硫酸软骨素、硫酸皮肤素、肝素、硫酸乙酰肝素或硫酸角质素。
5、根据权利要求1、2、3或4所述的带生物膜的血管瘤夹，其特征在于：所述生物膜(3)的长度与相对应的由所述半套环(8)和所述半套环(9)所形成的套环(10)的周长相等。
6、一种制备权利要求2所述的带生物膜的血管瘤夹的制备方法，其特征在于：其生物膜(3)是以天然的动物坚韧膜组织为原料，采取以下基本步骤制成：
①、预处理：使用广谱灭菌剂进行初步灭菌后修剪去除多余组织；
②、交联固定：使用固定剂交联生物膜(3)中的蛋白质分子，使稳定；
③、去除抗原：使用活泼试剂封闭生物膜(3)蛋白质中特殊位置的活性基团-OH或-NH2或-SH，并用强氢键试剂置换生物膜(3)蛋白质分子螺旋链中的特殊氢键；
最后将得到的生物膜(3)的两端分别用医用胶粘剂固定在金属夹的所述第一夹臂(1)、第二夹臂(2)上。
7、根据权利要求5所述的带生物膜的血管瘤夹的制备方法，其特征在于：它还包括在生物膜(3)的表面上通过偶联剂偶联含有特定多肽或糖胺聚糖类活性组分形成活性表面层(4)的步骤。
8、根据权利要求6所述的带生物膜的血管瘤夹的制备方法，其特征在于：所述的特定多肽之一是由16个赖氨酸(K16)、甘氨酸(G)、精氨酸(R)、天冬氨酸(D)、丝氨酸(S)、脯氨酸(P)及半胱氨酸(C)缩聚而成的，所述的糖胺聚糖是透明质酸、硫酸软骨素、硫酸皮肤素、肝素、硫酸乙酰肝素或硫酸角质素。
9、根据权利要求5或6所述的带生物膜的血管瘤夹的制备方法，其特征在于：所述的固定剂为易与蛋白质分子发生交联反应的环氧化物、二酰二胺、二异氰酸酯或碳化二亚胺中的一种或两种试剂，所述的环氧化物可以是单环氧
也可以是双环氧化
，这里R＝CnH2n+1-，n＝0-10。
10、根据权利要求5或6所述的带生物膜的血管瘤夹的制备方法，其特征在于：所述的活泼试剂可以是小分子有机酸酐、酰氯、酰胺、单环氧化物等，强氢键试剂为胍类化合物。
11、根据权利要求6所述的带生物膜的血管瘤夹的制备方法，其特征在于所述的偶联剂可用二酰二胺或二酸酐或双环氧化物或其它能与-NH2，-OH，-COOH等起缩合反应的双官能团试剂。
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| JP2008524342A JP4891996B2 (ja) | 2005-08-04 | 2006-07-27 | 生物膜付の血管瘤クリップ |
| PCT/CN2006/001878 WO2007014518A1 (fr) | 2005-08-04 | 2006-07-27 | Clip pour hémangiome avec membrane biologique |
| CA2617668A CA2617668C (en) | 2005-08-04 | 2006-07-27 | A hemangioma clip having a biological membrame |
| RU2008107011/14A RU2423938C2 (ru) | 2005-08-04 | 2006-07-27 | Зажим с биомембраной для лечения гемангиомы и метод его изготовления |
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| US11/497,097 US8197500B2 (en) | 2005-08-04 | 2006-08-01 | Biological membrane-carrying aneurysm clip |
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| US9078657B2 (en) * | 2012-04-09 | 2015-07-14 | Joseph T McFadden | Aneurysm clip |
| CN105943112A (zh) * | 2016-06-06 | 2016-09-21 | 邵波 | 一种袪瘤法及袪瘤器具 |
| DE102020100718A1 (de) * | 2020-01-14 | 2021-07-15 | Aesculap Ag | Chirurgischer Clip, insbesondere Aneurysmenclip, mit passiver Beschichtung |
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- 2006-07-27 EP EP06775231A patent/EP1911406B1/en active Active
- 2006-07-27 JP JP2008524342A patent/JP4891996B2/ja active Active
- 2006-08-01 US US11/497,097 patent/US8197500B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| EP1911406B1 (en) | 2010-05-05 |
| AU2006275235B2 (en) | 2012-07-12 |
| DE602006014161D1 (de) | 2010-06-17 |
| AU2006275235C1 (en) | 2013-01-24 |
| CA2617668A1 (en) | 2007-02-08 |
| RU2008107011A (ru) | 2009-09-10 |
| ATE466529T1 (de) | 2010-05-15 |
| EP1911406A4 (en) | 2008-12-03 |
| WO2007014518A1 (fr) | 2007-02-08 |
| US20070032806A1 (en) | 2007-02-08 |
| AU2006275235A1 (en) | 2007-02-08 |
| CN100482178C (zh) | 2009-04-29 |
| JP4891996B2 (ja) | 2012-03-07 |
| RU2423938C2 (ru) | 2011-07-20 |
| JP2009502371A (ja) | 2009-01-29 |
| CA2617668C (en) | 2011-11-08 |
| EP1911406A1 (en) | 2008-04-16 |
| US8197500B2 (en) | 2012-06-12 |
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