CN100366303C - 肌腱、韧带防粘连生物膜的制备及应用 - Google Patents
肌腱、韧带防粘连生物膜的制备及应用 Download PDFInfo
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- CN100366303C CN100366303C CNB2004101015975A CN200410101597A CN100366303C CN 100366303 C CN100366303 C CN 100366303C CN B2004101015975 A CNB2004101015975 A CN B2004101015975A CN 200410101597 A CN200410101597 A CN 200410101597A CN 100366303 C CN100366303 C CN 100366303C
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- 210000003041 ligament Anatomy 0.000 title claims abstract description 18
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- 102000008186 Collagen Human genes 0.000 claims abstract description 10
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- 229920001436 collagen Polymers 0.000 abstract description 7
- 102000004190 Enzymes Human genes 0.000 abstract description 4
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- 102000004169 proteins and genes Human genes 0.000 abstract description 4
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- 230000002980 postoperative effect Effects 0.000 description 3
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- 241001465754 Metazoa Species 0.000 description 2
- 208000021945 Tendon injury Diseases 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 210000000988 bone and bone Anatomy 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
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- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/043—Proteins; Polypeptides; Degradation products thereof
- A61L31/044—Collagen
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Abstract
本发明公开的是提供一种具有孔隙、海绵状医用胶原蛋白材料，具有结构稳定、生物相容性好、可降解吸收的用于肌腱、韧带防粘连生物膜的制备方法及应用。由牛肌腱组织为基料，经过除杂、清洗、酸、碱、酶处理、硫酸软骨剂交联，将蛋白纯度在95%以上的I型胶原蛋白在冷冻干燥工艺下制成具有80-200μm孔隙、厚度在0.05～1.5mm可降解的生物膜。术中将缝合处理后的肌腱或者韧带在洁净的情况采用环裹包绕法将其覆盖。术后适当的早期活动。使外周组织在胶原膜上形成假膜，阻断外周组织和肌腱的粘连，达到防止肌腱和韧带的粘连。
Description
所属技术领域：
本发明涉及医学生物材料技术领域，具体涉及到一种对肌腱、韧带损伤以及术后防止粘连的生物膜的制备及应用。
背景技术：
随着医疗科学技术的进步及医学材料的不断发展，近年来在医疗领域以胶原蛋白为基础的产品获得了显著的发展，如中国专利，专利号为021212779，专利名称为医用胶原蛋白材料及其制造工艺就公开了一种医用胶原蛋白材料，以牛肌腱组织为基料，经过除杂、清洗、酸、碱、酶处理、硫酸软骨剂交联、冷冻干燥及环氧乙烷灭菌等工序制成具有孔隙、海绵状医用胶原蛋白材料，具有结构稳定、生物相容性好、可降解吸收的特点。目前，已在临床上用于硬脑膜、硬脊膜的修复和防粘连。使用这种材料与技术扩大和延伸到其他治疗领域是生物医学领域的重要课题。
目前，解决恢复骨外科手部因肌腱与韧带损伤术后的肌腱，韧带粘连是世界性的急需解决的难题，骨科手术后因瘢痕的形成造成肌腱和韧带的粘连而影响关节的正常活动，90％以上的无腱鞘肌腱损伤需要进行第一次术后的二次择期松解手术。目前，临床使用的地塞米松激素和生物蛋白胶以及其他材料的治疗效果不明显，不能有效的防止粘连的形成。
发明内容：
本发明的目的是提供一种具有孔隙、海绵状医用胶原蛋白材料，具有结构稳定、生物相容性好、可降解吸收的用于肌腱、韧带防粘连生物膜的制备方法及应用。
为了达到上述目的，本发明采用如下技术方案：由牛肌腱为基料，经过酸、碱、酶处理及硫酸软骨交联，冷冻干燥、灭菌后制成蛋白纯度在95％以上、孔隙为80～200μm、厚度0.05～1.5mm的海绵状I型胶原蛋白生物膜。在进行手部或其他部位的肌腱与韧带手术时在将其缝合后，将防粘连生物膜直接管状环绕覆盖在受损的肌腱或韧带上，阻断外界组织和其直接接触，肌腱外部组织因胶原膜的特殊结构使其产生假膜，阻止外部细胞的长入而形成粘连。
本发明所提供的I型胶原蛋白材料生物膜其蛋白纯度高，分子结构稳定，有特定的孔隙结构与人体组织有很好的生物相容性和可控制的降解吸收性，用于骨科手术后防止肌腱和韧带粘连，提供了疗效可靠，使用方便，具有广泛的应用价值。
具体实施方式：
本发明所提供的以I型胶原蛋白为材料的防止肌腱和韧带粘连的生物膜在动物实验中证明防粘连效果显著。具体实施方法为：由牛肌腱为基料，经过酸、碱、酶处理及硫酸软骨交联，冷冻干燥、灭菌后制成蛋白纯度在95％以上、孔隙为146μm、厚度0.2mm的海绵状I型胶原蛋白防粘连生物膜备用；在动物被损伤的四肢肌腱和韧带进行手术缝合后，将20×30mm的防粘连生物膜直接管状环绕覆盖在受损的肌腱或韧带上；然后外皮缝合并打石膏。手术2周后被动活动损伤的四肢，四周拆除石膏，继续被动活动损伤的四肢。12周将动物处死观察，防粘连生物膜起到了阻断外界组织和其直接接触的作用，肌腱和韧带外部组织因胶原膜的特殊结构使其产生假膜，阻止外部细胞的长入而形成粘连，防粘连效果显著。
Claims (3)
1.一种肌腱、韧带防粘连生物膜的制备方法，由牛肌腱为基料，经过酸、碱处理，蛋白酶处理及硫酸软骨素交联，干燥灭菌后制成孔隙为146μm，厚度为0.2mm的海绵状胶原蛋白生物膜。
2.权利要求1所述方法制得的一种肌腱、韧带防粘连生物膜，其特征在于：海绵状胶原蛋白生物膜的孔隙为146μm，厚度为0.2mm。
3.权利要求1所述方法制得的防粘连生物膜在制备肌腱、韧带防粘连生物膜中的应用。
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004101015975A CN100366303C (zh) | 2004-12-24 | 2004-12-24 | 肌腱、韧带防粘连生物膜的制备及应用 |
| PCT/CN2005/002012 WO2006066483A1 (fr) | 2004-12-24 | 2005-11-25 | Film biologique empechant l'adherence pour les ligaments de tendons et son application |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004101015975A CN100366303C (zh) | 2004-12-24 | 2004-12-24 | 肌腱、韧带防粘连生物膜的制备及应用 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1795933A CN1795933A (zh) | 2006-07-05 |
| CN100366303C true CN100366303C (zh) | 2008-02-06 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB2004101015975A Ceased CN100366303C (zh) | 2004-12-24 | 2004-12-24 | 肌腱、韧带防粘连生物膜的制备及应用 |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN100366303C (zh) |
| WO (1) | WO2006066483A1 (zh) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102078641A (zh) * | 2011-01-07 | 2011-06-01 | 北京天新福医疗器材有限公司 | 一种制备肌腱韧带防粘连膜的方法 |
| CN103341211B (zh) * | 2013-06-14 | 2014-10-29 | 张仲文 | 一种制备ⅰ/ⅱ胶原双层复合胶原膜的方法 |
| CN103393482B (zh) * | 2013-08-14 | 2016-04-06 | 北京瑞健高科生物科技有限公司 | 一种基于组织基质材料的乳房假体支撑装置及其制备方法 |
| CN105524965A (zh) * | 2016-02-26 | 2016-04-27 | 福建华灿制药有限公司 | 一种牛肌腱胶原蛋白的提取方法 |
| CN107335101B (zh) * | 2017-08-07 | 2022-10-04 | 北京湃生生物科技有限公司 | 一种复合胶原蛋白组织再生膜及其制备方法 |
| CN110893250B (zh) * | 2019-10-11 | 2022-03-15 | 许和平 | 瘢痕/粘连阻挡膜及其制备方法和用途 |
| CN115381593B (zh) * | 2022-08-17 | 2025-11-04 | 上海市第六人民医院 | 一种仿生腱鞘膜及制备方法 |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH10216214A (ja) * | 1996-11-13 | 1998-08-18 | Katsunari Nishihara | 医用材料 |
| WO2000032225A1 (en) * | 1998-12-03 | 2000-06-08 | University College London | Tissue repair |
| US20020028181A1 (en) * | 2000-04-28 | 2002-03-07 | Miller Mark E. | Polyacid/polyalkylene oxide foams and gels and methods for their delivery |
| CN1456362A (zh) * | 2002-05-09 | 2003-11-19 | 中国人民解放军军事医学科学院野战输血研究所 | 一种人工皮肤及其制备方法与应用 |
| CN1463984A (zh) * | 2002-06-10 | 2003-12-31 | 于海鹰 | 医用胶原蛋白材料及其制造工艺 |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT1278868B1 (it) * | 1995-10-27 | 1997-11-28 | Sanitaria Scaligera Spa | Metodo per l'ottenimento di un materiale riassorbibile atto ad essere utilizzato come elemento di rivestimento per la prevenzione di |
| CN1539515A (zh) * | 2003-11-03 | 2004-10-27 | 刘永庆 | 一种防术后粘连的生物材料及其制备方法 |
-
2004
- 2004-12-24 CN CNB2004101015975A patent/CN100366303C/zh not_active Ceased
-
2005
- 2005-11-25 WO PCT/CN2005/002012 patent/WO2006066483A1/zh not_active Ceased
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH10216214A (ja) * | 1996-11-13 | 1998-08-18 | Katsunari Nishihara | 医用材料 |
| WO2000032225A1 (en) * | 1998-12-03 | 2000-06-08 | University College London | Tissue repair |
| US20020028181A1 (en) * | 2000-04-28 | 2002-03-07 | Miller Mark E. | Polyacid/polyalkylene oxide foams and gels and methods for their delivery |
| CN1456362A (zh) * | 2002-05-09 | 2003-11-19 | 中国人民解放军军事医学科学院野战输血研究所 | 一种人工皮肤及其制备方法与应用 |
| CN1463984A (zh) * | 2002-06-10 | 2003-12-31 | 于海鹰 | 医用胶原蛋白材料及其制造工艺 |
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| Publication number | Publication date |
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| CN1795933A (zh) | 2006-07-05 |
| WO2006066483A1 (fr) | 2006-06-29 |
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