CN107693173A - 加强成骨型同种异体骨前路椎间隙融合器 - Google Patents
加强成骨型同种异体骨前路椎间隙融合器 Download PDFInfo
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A—HUMAN NECESSITIES
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Abstract
本发明公开了一种加强成骨型同种异体骨前路椎间隙融合器，包括融合器本体和紧密嵌设在开设于融合器本体上的填充孔内的填充骨块，所述填充骨块的高度小于或等于填充孔的高度，所述融合器本体的材质为同种异体骨，所述填充骨块的材质为松质骨。本发明生物相容性和成骨性能好，且具有足够的力学强度以满足支撑相应部位对力学的要求。
Description
技术领域
本发明属于医用生物植入材料和医疗器械技术领域，具体涉及一种加强成骨型同种异体骨前路椎间隙融合器，适用于同种异体骨前路椎间隙融合。
背景技术
前路椎间隙融合器应用于椎间盘突出患者摘除椎间盘后、椎滑脱和其它原因需行椎体融合术的患者，使病变的椎间隙发生骨性愈合维持脊柱的稳定性并维持椎间隙的高度，防止进一步的损伤导致神经受压迫。
椎间隙融合器类型很多，主要有TC4钛合金、聚醚醚酮(PEEK)聚合物材料、生物陶瓷等材料制成，在手术时，为提高骨愈合而产生的融合效果，在产品中部镂空腔内填充自体骨，使融合器产生力学支撑作用、植入的自体骨发生骨愈合而达到椎体间的融合。但这一传统填充融合方式存在诸多问题与不足之处，具体是：1、金属、高分子材料、生物陶瓷等材料制成融合器与椎体置换器，生物相容性较同种异体骨材料差，弹性模量与人体骨不一致，且这些材料本身不能形成新成骨，往往也不能降解被自身骨替代；2、自体骨取材有限、如从病人自身其它部位切取可能引发取骨区并发症等缺陷；3、手术时将自体骨填充入镂空的植骨腔，增加手术中操作的麻烦，且手术中切取的自体骨的形状往往不规则，与融合器镂空的植骨腔不相匹配，导致植骨效果受影响，融合效果差。
发明内容
本发明的目的在于提供一种加强成骨型同种异体骨前路椎间隙融合器，它生物相容性和成骨性能好，且具有足够的力学强度以满足支撑相应部位对力学的要求。
本发明解决其技术问题所采用的技术方案是：
一种加强成骨型同种异体骨前路椎间隙融合器，该融合器包括融合器本体和紧密嵌设在开设于融合器本体上的填充孔内的填充骨块，所述填充骨块的高度小于或等于填充孔的高度，所述融合器本体的材质为同种异体骨，所述填充骨块的材质为松质骨。
按上述技术方案，所述融合器本体的材质为皮质骨。
按上述技术方案，所述融合器本体进行表面脱钙处理。
按上述技术方案，所述融合器本体为经清除骨髓、脱脂、脱细胞、表面脱钙工艺处理后冷冻干燥、真空包装后经辐照灭菌而成的融合器本体。
按上述技术方案，所述填充骨块为经清除骨髓、脱脂、脱细胞、清除免疫原工艺处理后冷冻干燥、真空包装后经辐照灭菌而成的填充骨块。
本发明产生的有益效果是：本发明提供的融合器，其本体采用同种异体骨根据植入部位解剖结构要求设计制作，同种异体骨的力学性能与人骨完全一致，不会象其它材料会切割软骨终板导致椎间隙高度降低，生物相容性好，力学强度满足支撑相应部位对力学的要求，而且可以逐步通过“爬行替代”的组织学变化过程演变成病人自己的骨组织也达到和加强融合的目的；同时，通过在本体的填充孔内紧密填充由松质骨制作的填充骨块，可以使上下骨接触面早期通过骨传导方式形成新骨，达到骨愈合和融合目的。本发明由同种异体骨材料加工而成，避免了切取自体骨带来并发症等缺陷，而且在使用时可以直接植入，不需要再进行融合器或者置换器的植骨填充。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是本发明实施例的结构示意图；
图2是本发明实施例的分解图。
图中：1-融合器本体、101-填充孔、2-填充骨块。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
如图1、图2所示，一种加强成骨型同种异体骨前路椎间隙融合器，该融合器包括融合器本体1和紧密嵌设在开设于融合器本体1上的填充孔101内的填充骨块2，填充骨块2的高度小于或等于填充孔101的高度，融合器本体1的材质为同种异体骨，填充骨块2的材质为松质骨。
在本发明的优选实施例中，融合器本体的材质为皮质骨，皮质骨骨质密实，力学强度好，使愈合过程中产品不塌陷。
在本发明的优选实施例中，融合器本体不脱钙或者表面脱钙，其进行表面脱钙处理后，可产生一定的诱导成骨能力，加快融合器本体的融合。本实施例中，融合器本体内残留钙含量为8％-55％时，其诱导成骨能力最佳。
在本发明的优选实施例中，融合器本体为经清除骨髓、脱脂、脱细胞、表面脱钙处理后冷冻干燥、真空包装后经辐照灭菌而成的融合器本体，生物相容性好，无免疫排斥症状发生。
在本发明的优选实施例中，填充骨块为经清除骨髓、脱脂、脱细胞、清除免疫原工艺处理后冷冻干燥、真空包装后经辐照灭菌而成的填充骨块，生物相容性好，无免疫排斥症状发生。
应当理解的是，对本领域普通技术人员来说，可以根据上述说明加以改进或变换，而所有这些改进和变换都应属于本发明所附权利要求的保护范围。
Claims (5)
1.一种加强成骨型同种异体骨前路椎间隙融合器，其特征在于，该融合器包括融合器本体和紧密嵌设在开设于融合器本体上的填充孔内的填充骨块，所述填充骨块的高度小于或等于填充孔的高度，所述融合器本体的材质为同种异体骨，所述填充骨块的材质为松质骨。
2.根据权利要求1所述的加强成骨型同种异体骨前路椎间隙融合器，其特征在于，所述融合器本体的材质为皮质骨。
3.根据权利要求1所述的加强成骨型同种异体骨前路椎间隙融合器，其特征在于，所述融合器本体进行表面脱钙处理。
4.根据权利要求1所述的加强成骨型同种异体骨前路椎间隙融合器，其特征在于，所述融合器本体为经清除骨髓、脱脂、脱细胞、表面脱钙工艺处理后冷冻干燥、真空包装后经辐照灭菌而成的融合器本体。
5.根据权利要求1所述的加强成骨型同种异体骨前路椎间隙融合器，其特征在于，所述填充骨块为经清除骨髓、脱脂、脱细胞、清除免疫原工艺处理后冷冻干燥、真空包装后经辐照灭菌而成的填充骨块。
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021027281A1 (zh) * | 2019-08-10 | 2021-02-18 | 山东百多安医疗器械股份有限公司 | 一种多孔仿生颈椎椎间融合器及其制备方法 |
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| US20020029084A1 (en) * | 1998-08-03 | 2002-03-07 | Paul David C. | Bone implants with central chambers |
| CN101164626A (zh) * | 2007-10-16 | 2008-04-23 | 张旗 | 脱脂灭菌深低温同种异体骨的制备方法及应用 |
| CN102551926A (zh) * | 2012-02-09 | 2012-07-11 | 北京大清生物技术有限公司 | 腰椎融合器及其制作方法 |
| CN209548149U (zh) * | 2017-11-10 | 2019-10-29 | 湖北联结生物材料有限公司 | 加强成骨型同种异体骨前路椎间隙融合器 |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020029084A1 (en) * | 1998-08-03 | 2002-03-07 | Paul David C. | Bone implants with central chambers |
| CN101164626A (zh) * | 2007-10-16 | 2008-04-23 | 张旗 | 脱脂灭菌深低温同种异体骨的制备方法及应用 |
| CN102551926A (zh) * | 2012-02-09 | 2012-07-11 | 北京大清生物技术有限公司 | 腰椎融合器及其制作方法 |
| CN209548149U (zh) * | 2017-11-10 | 2019-10-29 | 湖北联结生物材料有限公司 | 加强成骨型同种异体骨前路椎间隙融合器 |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021027281A1 (zh) * | 2019-08-10 | 2021-02-18 | 山东百多安医疗器械股份有限公司 | 一种多孔仿生颈椎椎间融合器及其制备方法 |
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Application publication date: 20180216 |