WO2014101254A1 - 弹性硬脑膜 - Google Patents
弹性硬脑膜 Download PDFInfo
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- WO2014101254A1 WO2014101254A1 PCT/CN2013/000733 CN2013000733W WO2014101254A1 WO 2014101254 A1 WO2014101254 A1 WO 2014101254A1 CN 2013000733 W CN2013000733 W CN 2013000733W WO 2014101254 A1 WO2014101254 A1 WO 2014101254A1
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- WIPO (PCT)
- Prior art keywords
- collagen
- dura mater
- cross
- dimensional structure
- linking
- Prior art date
Links
- 210000001951 dura mater Anatomy 0.000 title claims abstract description 22
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims abstract description 36
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims abstract description 32
- 102000008186 Collagen Human genes 0.000 claims abstract description 21
- 108010035532 Collagen Proteins 0.000 claims abstract description 21
- 229920001436 collagen Polymers 0.000 claims abstract description 21
- 102000012422 Collagen Type I Human genes 0.000 claims abstract description 16
- 108010022452 Collagen Type I Proteins 0.000 claims abstract description 16
- 238000004132 cross linking Methods 0.000 claims abstract description 8
- 239000012528 membrane Substances 0.000 claims abstract description 8
- 206010008164 Cerebrospinal fluid leakage Diseases 0.000 claims abstract description 4
- 206010015037 epilepsy Diseases 0.000 claims abstract description 3
- 230000004224 protection Effects 0.000 claims abstract 2
- 230000008439 repair process Effects 0.000 claims description 6
- 230000000694 effects Effects 0.000 claims description 3
- 239000000126 substance Substances 0.000 claims description 3
- 230000002776 aggregation Effects 0.000 claims description 2
- 238000004220 aggregation Methods 0.000 claims description 2
- 210000004027 cell Anatomy 0.000 claims description 2
- 239000000512 collagen gel Substances 0.000 claims description 2
- 238000000053 physical method Methods 0.000 claims description 2
- 210000003625 skull Anatomy 0.000 claims description 2
- 238000010276 construction Methods 0.000 claims 1
- 239000000463 material Substances 0.000 abstract description 14
- 230000001954 sterilising effect Effects 0.000 abstract description 12
- 238000004806 packaging method and process Methods 0.000 abstract description 10
- 238000000034 method Methods 0.000 abstract description 7
- 230000006835 compression Effects 0.000 abstract description 2
- 238000007906 compression Methods 0.000 abstract description 2
- 238000007789 sealing Methods 0.000 abstract description 2
- 230000010261 cell growth Effects 0.000 abstract 1
- 238000002360 preparation method Methods 0.000 abstract 1
- 230000002265 prevention Effects 0.000 abstract 1
- 238000004659 sterilization and disinfection Methods 0.000 description 11
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 9
- 239000004971 Cross linker Substances 0.000 description 7
- 210000004379 membrane Anatomy 0.000 description 5
- 230000007547 defect Effects 0.000 description 3
- 210000003516 pericardium Anatomy 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 241000283690 Bos taurus Species 0.000 description 2
- 241000700605 Viruses Species 0.000 description 2
- 230000000735 allogeneic effect Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 210000004556 brain Anatomy 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 210000004303 peritoneum Anatomy 0.000 description 2
- 230000008733 trauma Effects 0.000 description 2
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 206010010356 Congenital anomaly Diseases 0.000 description 1
- 206010061598 Immunodeficiency Diseases 0.000 description 1
- 208000029462 Immunodeficiency disease Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 241001494479 Pecora Species 0.000 description 1
- 208000030886 Traumatic Brain injury Diseases 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 229940096422 collagen type i Drugs 0.000 description 1
- 238000007428 craniotomy Methods 0.000 description 1
- 230000002498 deadly effect Effects 0.000 description 1
- 230000006837 decompression Effects 0.000 description 1
- 102000013373 fibrillar collagen Human genes 0.000 description 1
- 108060002894 fibrillar collagen Proteins 0.000 description 1
- 208000006454 hepatitis Diseases 0.000 description 1
- 231100000283 hepatitis Toxicity 0.000 description 1
- 230000008105 immune reaction Effects 0.000 description 1
- 230000007813 immunodeficiency Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 238000007917 intracranial administration Methods 0.000 description 1
- 210000000713 mesentery Anatomy 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- KKCBUQHMOMHUOY-UHFFFAOYSA-N sodium oxide Chemical compound [O-2].[Na+].[Na+] KKCBUQHMOMHUOY-UHFFFAOYSA-N 0.000 description 1
- 229910001948 sodium oxide Inorganic materials 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
- A61L27/24—Collagen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/34—Materials or treatment for tissue regeneration for soft tissue reconstruction
Definitions
- the invention relates to a biofilm material prepared by physical and chemical treatment of type I collagen. It has certain elasticity and toughness, and has good sealing and biocompatibility. Dura mater replacement material for brain surgery dural repair. It belongs to the field of medical biomaterials.
- the allogeneic dura mater has two significant weaknesses: one is that the source of the material is limited and expensive; the other is the most deadly weakness, the presence of a protein virus: the human dry frozen dura mater may cause hepatitis, immunodeficiency virus or bacterial infection.
- Bio-alternative materials are very effective as a substitute for dura mater, have good biocompatibility, are easy to operate, have a wide range of sources, and are inexpensive, and are a dural substitute material with more development potential.
- bovine pericardium In the domestic clinical practice, bovine pericardium, sheep pericardium, pig pericardium, bovine peritoneum, porcine peritoneum, mesentery, etc. are often used instead of dura mater.
- there are disadvantages such as adhesion, difficulty in preservation, difficulty in disinfection, and possible immune reaction.
- the method has the advantages that the spatial structure of the dura mater material prepared by the method has good compactness, uniformity, certain elasticity, toughness and compression resistance, can effectively prevent leakage of cerebrospinal fluid, and maintain the original activity of collagen, which is beneficial to hard.
- the growth of meningeal cells, and the possibility of adhesion to the skull by a single-sided physical cross-linking, for the repair of the dura mater, to prevent the occurrence of epilepsy Provides a strong guarantee.
- This material is prepared by a method in which type I collagen is chemically and physically aggregated to form a relatively stable molecular space structure. It can maintain the original activity of collagen to meet the requirements of dural repair. The main steps are as follows:
- the collagen membrane is dehydrated, the water content is 5. 0% ⁇ 40. 0%, sealed packaging, irradiation sterilization.
- Example 2 a commercially available type I collagen 10. 0g, soaked in a concentration of 100ml of 0.05 mol / L hydrochloric acid solution. After fully immersing, it was fixed and cross-linked in an ultraviolet cross-linker for 300 min. Then, it was immersed in 0. OOlmol/L sodium hydroxide solution for 15 minutes, and the pH value was 7. The obtained polymerized collagen was dehydrated to have a water content of 10.0%. After sterilization and packaging, it is irradiated and sterilized.
- Embodiment 3 5 ⁇ /L hydrochloric acid solution, immersed in a concentration of 0. 5mol / L hydrochloric acid solution. After fully immersing, it was fixed and cross-linked in an ultraviolet cross-linker for 90 min. Then, it was immersed in 2. Otnol/L sodium hydroxide solution for 1 min, and the pH was 6. 0% ⁇ The obtained polymerized collagen was dehydrated to a water content of 20.0%. After sterilization and packaging, it is irradiated and sterilized.
- the solution is immersed in a concentration of 1.0 ml of a hydrochloric acid solution. After fully immersing, it was fixed and cross-linked in an ultraviolet cross-linker for 90 min. Then, it was immersed in a 0 mol/L sodium hydroxide solution for 2 minutes, and the pH was 8. The obtained polymeric collagen was dehydrated to have a water content of 10.0%. After sterilization and packaging, it is irradiated and sterilized.
- Example 5 the commercially available type I collagen 0. lg, soaked in 100ml concentration of 0.01 mol / L hydrochloric acid solution. After fully immersing, it was fixed and cross-linked in an ultraviolet cross-linker for 90 min. Then, it was immersed in O. OOlmol/LgL sodium oxide solution for 2rain, pH 6. 0% ⁇ The obtained collagen was dehydrated to a water content of 30.0%. After sterilization and packaging, it is irradiated and sterilized.
- Omol/L hydrochloric acid solution Omol/L hydrochloric acid solution.
- the solution was immersed in a concentration of 0. lmol / L hydrochloric acid solution. After fully immersing, it was fixed and cross-linked in an ultraviolet cross-linking instrument for 20 min. Then, it was immersed in a 1. Omol/L sodium hydroxide solution for 2 minutes, and the pH was 8. 0% ⁇
- the obtained polymeric collagen was dehydrated to a water content of 40.0%. After sterilization and packaging, it is irradiated and sterilized.
- Example 8 a commercially available type I collagen taken 0. 8g, soaked in 100ml concentration of 0. 7m O l / L hydrochloric acid solution. After fully immersing, it was fixed and cross-linked in an ultraviolet cross-linker for 200 min.
Abstract
本发明涉及一种可用于临床硬脑膜重建的支架材料及其制备方法，所述方法包括将I型胶原浸泡在盐酸溶液中，铺膜，在紫外灯下进行紫外交联，通过氢氧化钠溶液灭菌处理，胶原膜脱水，密封包装，辐照灭菌制得弹性硬脑膜。通过此方法制备所得的材料具有致密性好、均匀，有一定的弹性和韧性、抗压，能有效防止脑脊液渗漏，且维持胶原的原有活性，利于硬脑膜细胞的生长，通过单面物理交联的方法降低了与颅盖骨的粘连概率以及为硬脑膜修复，防止癫痫的发生提供了有力保障等。
Description
说 明 书 弹性硬脑膜
技术领域
本发明涉及一种 I型胶原经过物理、 化学方法处理制得的生物膜材料。 有一定的弹性和 韧性， 密封性及生物相容性较好。 用于脑外科硬脑膜修复术的硬脑膜替代材料。 属于医用生 物材料领域。
背景技术
目前世界脑外科开颅手术中为了防止脑脊液渗漏造成颅内感染， 需要做人工硬脑膜修复 的患者有 10%〜15¾。 主要体现在： 脑创伤直接损伤， 肿瘤的浸润， 手术过程中硬脑膜切开减 压， 以及一些先天性的因素造成的硬脑膜缺损。 过去常用的硬脑膜修补材料为自体膜， 但由 于受取材尺寸和形状的限制和手术繁杂及产生新的创伤等因素， 大多是小面积的缺损采用自 体膜替代硬脑膜， 大面积的缺损还是要靠其他硬脑膜替代材料来完成。
当前市场硬脑膜替代材料有异体硬脑膜、 生物替代材料硬脑膜。 异体硬脑膜有两个显著 的弱点， 一是材料来源受限且价格昂贵； 二是最致命的弱点， 蛋白病毒的存在： 人体干冻硬 脑膜可能引起肝炎， 免疫缺陷病毒或细菌的感染等。 生物替代材料作为硬脑膜替代材料是非 常有效的， 具有良好的生物适应性， 且易于操作、 来源广泛、 价格低廉， 是较有发展潜力的 一种硬脑膜替代材料。 国内临床上常使用牛心包、 羊心包、 猪心包、 牛腹膜、 猪腹膜、 肠系 膜等代替硬脑膜。 但同时又有导致粘连、 不易保存、 不易消毒、 有可能发生免疫反应等缺点。
有鉴于此， 开发一种生物相容性好； 有一定的弹性和韧性； 能够在新生组织生成以后被 完全吸收； 防粘连； 容易保存， 操作方便； 材料来源广泛 ,· 价格相对适中的生物硬脑膜变的 尤为重要。 由于天然硬脑膜的主要成分为纤维胶原， 故本公司釆用了利用 I型胶原不同浓度下 本身固有的三维结构， 通过化学、 物理的方法将其聚集形成相对稳定的分子空间结构的聚合 胶原膜的方法制得， 此方法制得的硬脑膜替代材料空间结构致密性好， 均匀， 有一定的弹性 和韧性、 抗压， 能有效防止脑脊液渗漏， 且维持了胶原的原有活性， 利于硬脑膜细胞的生长， 再者通过单面物理交联的方法降低了与颅盖骨的粘连概率， 为硬脑膜修复， 防止癫痫的发生
提供了有力保障。
发明内容 本材料选用了 I型胶原通过化学、物理的方法将其聚集形成相对稳定的分子空间结构的方 法制成。 能够维持胶原的原有活性达到硬脑膜修复的要求。 主要操作步骤如下：
1、 I型胶原三维结构的初建： 市售 I型胶原， 浸泡于 0. 01inOl/L〜1. 0 niol/L的盐酸溶液， 制得浓度为 0. 1%〜60. 0% (w/w) 的胶原溶液或胶原凝胶。
2、 I型胶原三维结构的固定和防粘连的处理： 将初步构建好结构的 I型胶原拫据所需的尺 寸进行铺膜， 然后将膜的一面暴露在紫外灯下进行紫外交联， 交联时间 30mir！〜 500rain。
3、 I型胶原的聚集： 将市售氢氧化钠， 配制成浓度为 0. 001iTOl/L〜2. 0mOl/L的溶液， 灭 菌处理， 然后将经过三维结构固定和防粘连处理的胶原膜浸泡在氢氧化钠溶液中 1πΰη〜 30min。 最终 PH值为 （6〜8 )。
4、 弹性硬脑膜的形成： 将聚集好的胶原膜脱水， 使其含水量为5. 0%〜40. 0%，密封包装， 辐照灭菌。
具体实施方式
实施例 1、 取市售 I型胶原 1. 0g， 浸泡在 100ml浓度为 0. 2mol/L盐酸溶液中。 充分浸泡后固定成形， 在紫外交联仪内交联 90inin。 然后放进 1. Omol/L氢氧化钠溶液中浸泡 2min， pH值为 8。 将所得 聚合胶原脱水， 使其含水量为 40. 0%。 密封包装后辐照灭菌。
实施例 2、 取市售 I型胶原 10. 0g， 浸泡在 100ml浓度为 0. 05mol/L盐酸溶液中。充分浸泡后固定成形， 在紫外交联仪内交联 300min。 然后放进 0. OOlmol/L氢氧化钠溶液中浸泡 15min， pH值为 7。 将 所得聚合胶原脱水， 使其含水量为 10. 0%。 密封包装后辐照灭菌。
实施例 3、
取市售 I型胶原 15. Og, 浸泡在 100ml浓度为 0. 5mol/L盐酸溶液中。 充分浸泡后固定成形， 在紫外交联仪内交联 90min。 然后放进 2. Otnol/L氢氧化钠溶液中浸泡 lmin, pH值为 6。 将所得 聚合胶原脱水， 使其含水量为 20. 0%。 密封包装后辐照灭菌。
实施例 4、 取市售 I型胶原 60. 0g， 浸泡在 100ml浓度为 l. Omol/L盐酸溶液中。 充分浸泡后固定成形， 在紫外交联仪内交联 90min。 然后放进 1. 0mol/L氢氧化钠溶液中浸泡 2min， pH值为 8。 将所得 聚合胶原脱水， 使其含水量为 10. 0%。 密封包装后辐照灭菌。
实施例 5、 取市售 I型胶原 0. lg， 浸泡在 100ml浓度为 0. 01mol/L盐酸溶液中。 充分浸泡后固定成形， 在紫外交联仪内交联 90min。 然后放进 O. OOlmol/LgL氧化钠溶液中浸泡 2rain， pH值为 6。 将所 得聚合胶原脱水， 使其含水量为 30. 0%。 密封包装后辐照灭菌。
实施例 6、 取市售 I型胶原 30. 0g， 浸泡在 100ml浓度为 0. 2mol/L盐酸溶液中。 充分浸泡后固定成形， 在紫外交联仪内交联 150min。 然后放进 0. 05mol/L氢氧化钠溶液中浸泡 2πΰη， ΡΗ值为 6。 将所 得聚合胶原脱水， 使其含水量为 20. 0%。 密封包装后辐照灭菌。
实施例 7、 取市售 I型胶原 20. 0g, 浸泡在 lOOml浓度为 0. lmol/L盐酸溶液中。 充分浸泡后固定成形， 在紫外交联仪内交联 20min。 然后放进 1. Omol/L氢氧化钠溶液中浸泡 2min, pH值为 8。 将所得 聚合胶原脱水， 使其含水量为 40. 0%。 密封包装后辐照灭菌。 实施例 8、 取市售 I型胶原 0. 8g， 浸泡在 100ml浓度为 0. 7mOl/L盐酸溶液中。 充分浸泡后固定成形， 在紫外交联仪内交联 200min。然后放进 0. 05mol/L氢氧化钠溶液中浸泡 20min， pH值为 8。将所 得聚合胶原脱水， 使其含水量为 5. 0%。 密封包装后辐照灭菌。
Claims
1、 一种由 I型胶原本身固有的三维结构通过化学、 物理的方法将其聚集形成相对稳定的 分子空间结构的聚合胶原膜， 其致密性好， 均匀， 有一定的弹性和韧性、 抗压， 能有效防止 脑脊液渗漏， 且维持了胶原的原有活性， 利于硬脑膜细胞的生长， 再者通过单面物理交联的 方法降低了与颅盖骨的粘连概率， 为硬脑膜修复， 防止癫痫的发生提供了有力保障。 其特 征包括下列步骤
( 1 )、市售 I型胶原，浸泡于 0.01mol/L〜1.0 mol/L的盐酸溶液，制得浓度为 0.1%〜60.0% (w/w) 的胶原溶液或胶原凝胶。 初建一定空间的三维结构。
(2)、将初步构建好结构的 I型胶原根据所需的尺寸进行铺膜，然后将膜的一面暴露在紫 外灯下进行紫外交联， 交联时间 30〜500min。 对一定空间的三维结构进行固定和紫外处理， 以防粘连。
(3 )、 将市售氢氧化钠， 配制成浓度为 0.001mol/L〜2.0mol/L的溶液， 灭菌处理， 然后将 经过三维结构固定和防粘连处理的胶原膜浸泡在氢氧化钠溶液中 l〜30min。 最终 PH值为
(6〜8 )。 聚集稳定 I型胶原的三维空间结构。
(4)、 将聚集好的胶原膜脱水， 使其含水量为 5.0%〜40.0¼, 密封包装， 辐照灭菌。 制得 弹性硬脑膜。
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| Application Number | Priority Date | Filing Date | Title |
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| CN201210589564.4A CN103897211A (zh) | 2012-12-26 | 2012-12-26 | 弹性硬脑膜 |
| CN201210589564.4 | 2012-12-26 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1149498A (zh) * | 1995-10-31 | 1997-05-14 | 株式会社生物工程技术研究所 | 医用材料及其制造方法 |
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| WO2006029571A1 (en) * | 2004-09-14 | 2006-03-23 | The University Of Hong Kong | Photochemically crosslinked collagen scaffolds and methods for their preparation |
| CN102716517A (zh) * | 2011-03-30 | 2012-10-10 | 深圳兰度生物材料有限公司 | 一种引导组织再生膜及其制备方法 |
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| CN1253473C (zh) * | 2002-06-10 | 2006-04-26 | 于海鹰 | 医用胶原蛋白材料及其制造工艺 |
| CN103071189B (zh) * | 2013-01-25 | 2014-09-03 | 广州华美康联生物科技有限公司 | 一种组织引导再生用胶原膜的制备方法 |
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