WO2007014518A1 - Clip pour hémangiome avec membrane biologique - Google Patents

Clip pour hémangiome avec membrane biologique Download PDF

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Publication number
WO2007014518A1
WO2007014518A1 PCT/CN2006/001878 CN2006001878W WO2007014518A1 WO 2007014518 A1 WO2007014518 A1 WO 2007014518A1 CN 2006001878 W CN2006001878 W CN 2006001878W WO 2007014518 A1 WO2007014518 A1 WO 2007014518A1
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WO
WIPO (PCT)
Prior art keywords
biofilm
clip
acid
active
preparing
Prior art date
Application number
PCT/CN2006/001878
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English (en)
French (fr)
Inventor
Songtao Qi
Guofeng Xu
Original Assignee
Summit (Gd) Biotech Co., Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Summit (Gd) Biotech Co., Ltd filed Critical Summit (Gd) Biotech Co., Ltd
Priority to CA2617668A priority Critical patent/CA2617668C/en
Priority to EP06775231A priority patent/EP1911406B1/en
Priority to AT06775231T priority patent/ATE466529T1/de
Priority to DE602006014161T priority patent/DE602006014161D1/de
Priority to JP2008524342A priority patent/JP4891996B2/ja
Priority to AU2006275235A priority patent/AU2006275235C1/en
Publication of WO2007014518A1 publication Critical patent/WO2007014518A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A61B17/1227—Spring clips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00884—Material properties enhancing wound closure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00893—Material properties pharmaceutically effective

Definitions

  • the present invention relates to a hemangioma clip which is a device for treating a hemangioma that is implanted into a human body.
  • Aneurysms are common vascular diseases.
  • the iliac crest is clipped from the root (parallel to the vessel wall) with a blood vessel clamp.
  • the tumor drug is closed, which is a simple treatment method, especially suitable for those parts that are difficult to be used. This method has been used in clinical applications for a long time, and the short-term effect is good.
  • the other side of the blood vessel wall which is in the axial direction is also thinned, and the other side of the tumor capsule may be further thinned to form a new tumor capsule, and the treatment effect is not satisfactory.
  • fusiform hemangioma the common hemangioma clip is even more powerless.
  • the object of the present invention is to provide a novel biofilm-bearing hemangioma clip with a tough biofilm which can cover the peripheral portion of the blood vessel at the clip site to prevent the site from being blocked. Further tumor transformation and prevention of rupture of the tumor capsule have a significant effect, which can greatly improve the therapeutic effect.
  • Another object of the present invention is to provide a method for producing the above-described biofilm-containing hemangiomas.
  • the technical solution of the present invention is: a hemangio clip with a biofilm, which is composed of a gold clip and a film, wherein the metal clip is made of medical stainless steel or titanium alloy, and the structure includes the tails connected to each other by elastic means.
  • a first clamping rod and a second clamping rod that are cross-spliced, a half love ring on the first clamping rod and The ends of the half sleeves on the second clamping rod are respectively provided with a first clamping arm and a second clamping arm, and two ends of the bio glue are respectively fixed on the first clamping arm and the second clamping arm to form a film sleeve.
  • the biofilm is a membrane formed by cross-linking and de-antigen treatment of a diaphragm, a fat omentum, a pericardium or a intestinal membrane of a pig, a cow or a sheep, which is easy to obtain and has a low cost. , is conducive to the promotion of applications.
  • aldehydes (formaldehyde, glutaraldehyde, etc.) are cross-linked with them to improve their stability.
  • aldehydes are crosslinked with proteins by acetal reaction.
  • toxic aldehydes are released, so that the articles fixed with aldehyde have long-term residual properties.
  • a non-aldehyde fixing agent such as an epoxide, a diacid diamine, a diisocyanate or a carbodiimide is used, there is no such disadvantage.
  • an epoxide the epoxide is crosslinked by the ring opening reaction.
  • the protein rot molecules can not easily form epoxides after ring opening.
  • the degradation products are polyols that can be metabolized by the body, and have no residual toxicity of aldehydes.
  • the stability of treated animal tissues is also better than that of aldehydes.
  • the antigenicity of animal tissues is mainly caused by the active groups and specific isoforms of certain special positions a in the protein. These active groups mainly include -OH, -N3 ⁇ 4, -SH, etc.
  • the specific isomer is usually caused by some special hydrogen bonds of the helical chain of the protein molecule.
  • one or more active reagents such as acid anhydride, acid chloride, amide, ring
  • Oxide, etc. are combined with these groups to block them to remove their antigens.
  • strong hydrogen bond reagents such as terpenoids
  • Change its conformation to further eliminate antigenicity.
  • the biofilm-bearing hemangioma can be used to clamp the peripheral part of the blood vessel in the clamped area, and the biofilm can also grow together with the outer membrane of the blood vessel, thereby enhancing the bioreinforcement. Function, play a very good therapeutic effect.
  • an active surface layer of a specific polypeptide or glycosaminoglycan active component which can adhere to a growth factor is coupled to the surface of the biofilm prepared using the animal tough tissue.
  • One of the specific polypeptides is composed of 16 lysine (K16), glycyrrhizic acid (G), arginine (R), aspartic acid (D) serine (S), proline (P) And the polycondensation of cysteine (C), wherein the glycosaminoglycan is hyaluronic acid, chondroitin sulfate, dermatan sulfate, hepatic violet, acetylhepatitis sulfate or sulphate.
  • These active components facilitate the growth of the encapsulated blood wall cells and fuse with the vascular wall tissue.
  • the length of the biofilm is equal to the corresponding circumference of the loop formed by the semi-ankle ring.
  • Pretreatment Pruning and removing excess tissue after initial sterilization using broad-spectrum sterilizing agent
  • Cross-linking fixation cross-linking protein molecules in the membrane with a fixative
  • Removal of antigen Use active reagent to block the activity of the special site S in the membrane protein such as -OH, -NH 2 , -SH, etc., and use the strong hydrogen bond reagent g to change the special hydrogen bond in the helical chain of the membrane protein molecule. ;
  • the preparation method of the biofilm-bearing hemangiomas folder further comprises the step of coupling the active component containing the specific polypeptide or the glycosaminoglycan active component to the surface of the biodegradation by a coupling agent to form an active surface layer.
  • the immobilizing agent described in each method for producing a biofilm-bearing hemangiomas is one or both of an epoxide, a diacid diamine, a diisocyanate or a carbodiimide which is easily crosslinked with a white matter molecule.
  • the reagent is preferably an epoxide, and the epoxide may be a monoepoxide K-CH-CH 2 or a double epoxide.
  • the active reagent described in the method for producing a biofilm-bearing hemangioprobe may be a small molecule organic acid anhydride, an acid chloride, an amide, a monoepoxide or the like, and the strong hydrogen bonding reagent is an anthraquinone compound.
  • the preparation method for the preparation of the active surface layer containing the specific polypeptide or glycosaminoglycan active component in the preparation method of the biofilm-bearing hemangio clip can be used with a diacyl diamine or a dianhydride or a double epoxide or it can -NH 2 , -OH, -COOH, etc.
  • the biofilm-bearing hemangioma has a biofilm with good biocompatibility, and can wrap the outer circumference of the blood vessel in the clip portion to prevent the hemangioma from deteriorating and can be associated with the blood vessel.
  • the outer walls are long together, which plays a role in bio-enhancement and reinforcement.
  • the treatment effect is good and the use is safe and reliable.
  • FIG. 1 is a schematic structural view of an embodiment of the present invention
  • Figure 2 is an enlarged view of a portion A in the embodiment of the present invention.
  • First clamp arm 2. Second clamp arm, 3. Biofilm, 4. Active surface layer, 5.
  • First clamping rod 6.
  • Second clamping rod 7.
  • Elastic fitting S 8, half sleeve , 9, half ring, 10, 3 ⁇ 4 ring.
  • a hemangioc clip with a bio-pancreas is composed of a gold clip and a biofilm 3, wherein the gold clip includes a first cross-joined joint of the tail connected by the elastic means 7.
  • the clamping rod 5 and the second clamping rod 6 are respectively provided with a first clamping arm 1 and a second clamping arm 2 at the ends of the half collar 8 on the first clamping rod 5 and the half ring 9 on the second clamping rod 6 respectively. Both ends of the biofilm 3 are fixed to the first clamp arm 1 and the second clamp arm 2, respectively, to form a film sleeve.
  • the length of the biofilm 3 is equal to the corresponding circumference of the collar 10 formed by the semi-annulus 8 and the half collar 9, and the width thereof is the same as the arm length of the clip or the length of each end is long. Out 1-2mm.
  • the surface of the biofilm 3 contains an active surface layer 4 formed by coupling a specific polypeptide or a glycosaminoglycan active component which can adhere to a growth factor.
  • the specific polypeptide is composed of 16 lysine ( ⁇ 6), glycine (G:), arginine (10, aspartic acid (D), serine (S), proline (P) and cysteine.
  • the glycosaminoglycan is a hyaluronic acid, a cartilage sulfate, a dermatan sulfate, a heparin, a heparan sulfate or a keratan sulfate.
  • the biofilm 3 is a pig. A film formed by cross-linking of a cow's or sheep's diaphragm, fat omentum, pericardium or intestinal membrane by epoxide cross-linking and de-antigen treatment.
  • the gold clip is made of medical stainless steel or peptide alloy.
  • the preparation method of the hemangiomas with biofilm, the biofilm 3 is prepared by using the animal tough membrane tissue as a raw material, and the following steps are taken:
  • Pretreatment Pruning and removing excess tissue after initial sterilization using broad-spectrum sterilizing agent
  • cross-linking fixed using a fixative to crosslink the protein molecules in the biofilm 3, to make it stable;
  • the active surface layer 4 is formed by coupling a specific polypeptide or a glycosaminoglycan active component on the surface of the biofilm 3 by a coupling agent. Finally, the two ends of the obtained biofilm 3 are respectively fixed on the first clamp arm 1 and the second clamp arm 2 of the gold flexure with a medical adhesive, and the product of the present invention can be obtained.
  • the fixing agent is one or two reagents of an epoxide, a diacid diamine, a diisochlorite or a carbodiimide which are easily crosslinked with a protein molecule, and the epoxide may be Is a monoepoxide R-CH-CH2 or a bisepoxide CH ⁇ CH-(CH 2 ) n - CH- H 2 , which
  • the living cockroach reagent may be a small molecule organic acid anhydride, an acid chloride, an amide, a monocyclic thief, and a strong hydrogen bond reagent is a quinone compound.
  • the coupling agent may be a diacid diamine or a dianhydride or a diepoxide or other bifunctional reagent capable of undergoing condensation reaction with -NH 2 , -OH, -COOH or the like.

Description

带生物膜的血管瘤夹
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' 屈植入人体内 的医疗器械。
背 术
血管瘤尤其动脉瘤是常见的血管病之—， 血管瘤的治疗方法有多种， 对 于某些形态的血管瘤，用血管夹将瘤粱从根部（与血管壁平行的方位）夹死， 令瘤藥关闭， 是一种简便的治疗方法， 特别适用于那些难于 ^鹧的部位， 这 一种方法己经在临床应用多时， 短期效果良好。 但由于形成血^痫时， 其于 轴向垂宜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¾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各方法。
本发明的技术解决方案是： 带生物膜的血管瘤夹， 它由金屈夹和 ^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搽接的第一夹杆和第二夹杆， 在第一夹杆上的半恋环和 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， 生物胶的两端分 别 II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、 心包胶或肠膜经 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 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， 由于环氧化物是翁开环反应来交联蛋白腐 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商； 根据现代兔疫学理论， 动物组织的抗原性主要是由蛋白质中某些特殊位 a的 活性基团及特异构象引起的， 这些活性基团主要有 -OH, -N¾， -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氫键引起， 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 ^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阖定后， 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瑋性，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¾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¾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)、 甘氮酸（G)、 精氮酸 （R)、 天冬氨酸 (D) 丝氨酸（S)、 脯氨酸（P)及半胱氮酸（C)缩聚而成的， 所述的糖胺 聚糖是透明质酸、 硫酸软骨索、 硫酸皮肤素、 肝紫、 硫酸乙酰肝紫或硫酸^ 质素。 这些活性组分有利于所包喪的血^壁细胞长入并与血管壁组织融合在
—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袞环所形成的 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 韧胶組织为原料， 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： 使用固定剂交联周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 S的活性 ¾团 如 -OH, -NH2, -SH等， 并用强氢键试剂 g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屈夹的夹健上。 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脱 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各方法中所述的固定剂为易与 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 K- CH- CH2 , 也可以是双环氧化物
Figure imgf000006_0001
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，可阻止血管瘤迸一歩恶化， 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， 治疗效粜好， 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 S, 8、 半套环， 9、 半套环， 10、 ¾环。
具伴实嗨万式
实施例： 如附图 1和 2所示， 带生物胰的血管瘤夹， 它由金屈夹和生物 膜 3组成， 其中金屈夹包括尾部通过弹性装置 7相连的相互交叉搽接的第一 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 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 所述半袞环 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^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（Κί6)、甘氨酸（G：)、精氨酸（10、 天冬敏酸（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、 硫酸软骨萦、 硫酸皮肤素、 肝素、 硫酸乙酰肝紫或硫酸角质素。 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。 金屈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是以夭然的动物坚韧膜组 织为原料， 釆取以下步骤制备：
①、 预处理： 使用广谱灭菌剂进行初步灭菌后修剪去除多余組织；
②、 交眹固定： 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 S质中特殊位 g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糠胺聚糖类活性 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屈夾的所述第 —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、 二异氯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 R-CH-CH2 ， 也可以是双环氧化物 CH^CH- (CH2)n- CH- H2 ， 这
N0/ 、0
里 R=CnH2n+1—， n=0-10。 所述的活浚试剂可以是小分子有机酸酐、 酰氯、 酰胺、 单环諷化物笾， 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

权利蓥^
K 一种带生物膜的带生物膜的血管撤夹，其特征在于：它由金屈夹和生物
(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 ) 和第二夹槠 (2), 生物膜 C3) 的两端分别固定在所述第一夹臂 ( 1 ) 和第二夹锴 （2) 上， 形成膜袞。 、 根据权利要求 1所述的带生物膜的血哲'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、 心包膜或肠脱经交联固 定和去抗原处理后所形成的膜。
、 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)。
、 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个赖氮酸 （K16)、 甘氨酸 （G)、 糨筑酸 （R)、 天冬 氨酸 （!>)、 丝氮酸 （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、硫酸皮肤紮、肝紮、硫酸乙 酰肝素或硫酸角质素。
、 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¾环（9) 所形成的套环 （10) 的周长相等。 、 一种制备权利要求 2所述的带生物膜的血管痫夹的制各方法，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 ¾本 歩骤制成：
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 S的活性 基团 -OH或 -NH2或 -SH， 并用强氫键试剂置换生物膜 (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屈夾的所述 第一夹臂 （1 )、 第二夹臂 （2) 上。 、 根据权利耍求 5所述的带生物胶的血管瘤夹的制备方法， 其特征在于： 它还包括在生物胰 （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。 、 根锯权利要求 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)、粕氮酸（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、 硫酸皮肤萦、 肝紫、硫 酸乙酰肝素或硫酸角质素。 、 根据权利要求 5或 6所述的带生物脱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、二异執酸酯或碳化二亚胺中的一种或两种试剂，所述的环弒化物可 以是单环氧化物 K„GIW H2 , 也可以是双环氧化物 CH2 "~CH- (Cf )n-CH-^2
\0 、( 、(
， 这里
Figure imgf000010_0001
0、 根据权利要求 5或 6所述的带生物膜的血管瘤夹的制各方法，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。
根据权利要求 6所述的带生物胰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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