CN100394989C - 包含微粒状基于胶原材料的组合物的制药应用和包含所述组合物的滑膜关节 - Google Patents

包含微粒状基于胶原材料的组合物的制药应用和包含所述组合物的滑膜关节 Download PDF

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CN100394989C
CN100394989C CNB2003801033159A CN200380103315A CN100394989C CN 100394989 C CN100394989 C CN 100394989C CN B2003801033159 A CNB2003801033159 A CN B2003801033159A CN 200380103315 A CN200380103315 A CN 200380103315A CN 100394989 C CN100394989 C CN 100394989C
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H·H·特里优
M·C·舍曼
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Warsaw Orthopedic Inc
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Abstract

一种通过将基于胶原材料的微粒注射入关节来治疗滑膜关节的方法。微粒在植入之前可脱水，并在植入后再水合，或它们可以“湿”状态如浆或凝胶植入。可以包含放射造影材料以增强所注入材料的成像。其他添加剂可包含镇痛药、抗生素、蛋白聚糖、生长因子、和/或有效促进愈合和/或正常关节功能的其它细胞。

Description

包含微粒状基于胶原材料的组合物的制药应用和包含所述组合物的滑膜关节
发明领域
本发明一般涉及用于治疗滑膜关节的材料和方法，更具体地涉及使用基于胶原的材料增加滑膜关节的材料和方法。
发明背景
滑膜关节是哺乳动物附肢骨骼的最普通关节，代表高度进化的、可运动的关节。典型的滑膜关节包含两个被关节软骨层覆盖的骨末端。软骨是平滑和有弹性的，便于关节中骨的低摩擦运动。
骨末端和相关的软骨被一个关节囊-一个产生滑液的膜“袋”包围。囊和液体保护和支持软骨和结缔组织，给关节软骨传送营养物质并清除代谢废物。
关节软骨是骨骺上的透明软骨的一薄(2-3mm)。它没有软骨膜，因此损伤时修复能力有限。而且，自然老化过程可导致关节软骨某些程度的退化，减低其保护和缓冲骨末端的能力。
椎骨关节突关节，更好称为小平面关节，是将脊柱的各椎骨与其上方和/或下方椎骨相连接的结构方式。每一关节包含两个小平面骨-一个下方小平面和一个上方小平面-以一个椎骨的下方小平面连接于毗邻椎骨的上方小平面。关节便于椎骨相对于彼此运动并使脊柱弯曲和扭转。
如在所有滑膜关节中那样，小平面彼此连接处具有一个被薄层滑液润滑的软骨衬垫。软骨和滑液减少关节的摩擦力，延长关节的寿命并防止炎症和相关的疼痛。
当自然老化过程进展时，覆盖关节的软骨可退化并开始磨损。磨损过程可导致软骨小片脱离，以及以前平滑的表面可变得粗糙。然后面关节开始在一起摩擦，产生导致关节进一步损坏的摩擦力。并且，与关节相关的神经变得受刺激和发炎，导致严重的疼痛和限制脊柱的运动。
通常用于处理滑膜关节尤其是面关节退化的技术迄今关节主要依靠注射以阻止疼痛和减少炎症。但是这种治疗只是暂时的，很少产生基础状况的任何显著改善。
因此需要有效治疗退化的滑膜关节的材料和方法，具体是有效补充或代替润滑和保护关节的软骨的材料和方法。本发明针对这种需要。
发明概述
简要描述本发明的一个方面，提供通过向关节内注射一种以胶原为基础的材料来治疗滑膜关节的方法。该材料可以以脱水的形式注入，并在植入后再水化，或者可以以水化的形式注入，例如浆或凝胶。该材料可以是新鲜的或冷冻的。注入的材料中可以包含交联剂如戊二醛以促进胶原交联。此外，可以包含放射造影(radio-contrast)材料以增强注入材料的成像。类似地，可以包含性能增强添加剂例如镇痛药和/或抗生素以提供另外的治疗益处。
从以下描述中的本发明的目的和优点将显而易见。
附图简述
图1A-1D显示根据本发明的一个优选实施方案向面关节内注射一种以胶原为基础的材料的过程。
图2A-2F显示根据本发明的另一个优选实施方案向面关节内注射一种以胶原为基础的材料的过程。
优选实施方案描述
为了促进对本发明原理的理解，现提及并使用专门语言描述某些优选实施例。无论如何应理解并不因此打算限制本发明的范围，已考虑到本发明相关领域的技术人员通常会对优选实施方案作出这样的改变和进一步的改进。
如上指出的，本发明的一个方面涉及使用以胶原为基础的材料治疗滑膜关节退化的材料和方法。在最优选的实施方案中，该以胶原为基础的材料被注射到关节囊内。在一些优选实施方案中本发明的方法包括使用外科手术向滑膜关节添加一种包含微粒的以胶原为基础的材料的组合物。在其它实施方案中，本发明的方法包括使用外科手术向滑膜关节添加一种主要由微粒的以胶原为基础的材料构成的组合物。
以胶原为基础的材料可来源于天然、富含胶原的组织如椎间盘、筋膜、韧带、腱、去矿化的骨基质等。该材料可以是同源的、异源的、或异种的、或可以是人-重组来源。在可替换的实施方案中，以胶原为基础的材料可以是一种合成的、以胶原为基础的材料。优选的富含胶原的组织的例子包括盘环、阔筋膜、平面筋膜、前或后交叉韧带、髌骨腱、腘旁腱、四头肌腱、跟腱、皮肤和其它结缔组织。
以胶原为基础的材料可以以适合导入滑膜关节内的任何形式提供。例如，该材料可以是一种固体、多孔、编织、或非编织的材料，并可以作为微粒、小块、凝胶、溶液、混悬液、糊、纤维材料等提供。该材料可以在仍新鲜和水合时使用，或可以在处理后如冷冻和脱水后使用。
在一些实施方案中，该材料以脱水状态提供，并在关节注射后“再水合”。在其它实施方案中，该材料以水合的状态植入。当该材料以水化的状态植入时，它可能是因为从未被脱水或已被脱水并复原。当复原时，该材料可用盐水或另一水介质复原，或者可用非水介质例如乙二醇或酒精复原。并且，当以“水合”状态提供时，该材料可以作为凝胶、溶液、混悬液、分散体、乳剂、糊等提供。
在最优选的实施方案中，该材料是一种适合通过皮下注射针注射入滑膜关节内的微粒和/或纤维材料。
在最优选的实施方案中，胶原材料作为尺寸范围在0.05mm和5mm之间的微粒提供。当使用例如阔筋膜或盘环的材料时，微粒优选从0.1mm到5mm的尺寸范围。当使用例如去矿化的骨基质或明胶时，该微粒优选从0.05mm到3mm的尺寸范围。当使用材料小塞时，该塞优选从0.5mm到5mm的尺寸范围。在一些实施方案中，可以使用较大尺寸的块例如尺寸达20mm的块。
可以使用多于一种类型的组织加工或制备该材料。例如，在适当情况下可优选阔筋膜和去矿化的骨基质的混合物，如可以是DBM和环纤维材料的混合物。
可以在配方中加入交联剂以促进胶原材料的交联。例如，可以在配方中包含戊二醛或其它蛋白交联剂。交联剂可促进胶原分子间共价或非共价的交联。类似地，也可包含抑制蛋白变性的制剂。适合用于本发明中的交联剂是本领域技术人员熟知的，可以不经过度的实验而选择。
当材料用作浆或凝胶时，也可包含促进浆或凝胶形成的添加剂。这些添加剂可以促进蛋白折叠、水结合、蛋白-蛋白相互作用、和水固定。
此外，可以包含一种放射照相造影剂，例如硫酸钡，或一种放射造影染料，例如泛影酸钠(HYPAQUE
Figure C20038010331500071
)，以帮助外科医生追踪所注入材料的运动和/或位置。适合用于椎间盘造影术的放射造影材料是本领域技术人员已知的，可以不经过度的实验而选择用于本发明。
最后，还可以包含其它对所注入以胶原为基础的材料提供好处的添加剂。这样的添加剂包括镇痛药以减轻疼痛、抗生素以非潜在的细菌感染减至最低程度。
也可包含例如蛋白聚糖和/或透明质酸的多糖，以吸引或结合水来保持滑膜关节水合。此外，也可包含生长因子和/或其他细胞(例如椎间盘细胞、干细胞等)，以促进愈合、修复、再生和/或恢复关节，和/或促进正常的关节功能。适合用于本发明中的添加剂是本领域技术人员已知的，可以不经过度的实验而选择。
在一些实施方案中，胶原材料在注入关节之前被脱水，在那里它通过从周围区域吸收液体而再水合。在另一实施方案中，胶原材料在植入前作为凝胶、浆、或其他水合配方提供。
基于胶原的材料是“外科手术地添加”至滑膜关节。即，该材料通过医务人员的介入被添加，以区别于通过身体的自然生长或再生过程而“添加”。外科手术过程优选地包括通过皮下注射针注射，尽管可使用基于胶原的材料导入关节的其他外科手术方法。例如，该材料可通过经扩张的开口挤压、经导管灌注、经损伤或外科手术切口产生的开口植入，或通过其它非侵入性或最小限度地将该材料侵入性沉积入关节间隙的方法被导入滑膜关节，
现参考附图，图1A-1D显示了将基于胶原的材料注射入关节的一个方法。在图1A中，注射器12中提供了脱水微粒阔筋膜或环纤维材料11(在无菌包装中)。如图1B所示，该材料在悬浮液介质中再水合和/或分散，以提供基于胶原的材料的湿分散体13。皮下注射针14连接于注射器12，以及注射器被插入关节囊16(图1C)。如图1D所示，针头/注射器可在关节囊内各处移动，从一侧扫到另一侧和从后面扫到前面，以确保基于胶原的材料13在间隙内均匀分布。然而，优选针头的尖保持接近关节囊的中心，以确保该材料在间隙内的沉积和潜在的漏泄减至最低程度。
可选择地，如图2A-2F所示，小直径胶原塞21可插入关节。胶原塞21可先被压缩或插入小直径管22，并提供在传送套管23中(图2A-2C)。传送套管23连接于扩张器24。
压缩的塞通过使用导针27(图2D)穿刺关节而插入关节25。扩张器24，优选地已与传送套管23连接，插在导针27上面(图2E)。然后胶原塞21准备注射(或挤压)入关节。可以使用柱塞28从套管中推压胶原塞。胶原塞在退出扩张器时扩展，并且当它们在关节中重水合时可进一步扩展。
从本发明使用的方法和材料中得到的益处和优点包括以下：
(1)本发明为退化的滑膜关节提供润滑和/或缓冲，改善或恢复正常的关节功能；
(2)本发明提供的再水合预期减慢退化进程。
(3)本发明因改善关节的润滑而缓解疼痛。
(4)该过程是经皮的或最小侵入性的门诊患者过程。
(5)当类似技术和材料用于整容过程时，风险是最小的。
(6)由于使用天然的或人-重组的基于胶原的材料，所以材料是生物相容性的。
在一个优选实施方案中，本发明的材料和方法可用于治疗脊柱中的滑膜关节，具体是面关节。在其它优选实施方案中，髋、膝、踝、手指、脚趾、肘、肩、腕、骶髂、颞下颌、腕掌等关节可全部通过将胶原源性材料注入关节间隙以补充/增加润滑关节的软骨而治疗。
现参考使用上述过程的特定的例子。可以理解，提供的例子是为了更完整地描述优选实施方案，而不是限制本发明的范围。
实施例1
使用水合微粒的凝胶或悬浮液或如水、盐水或乙二醇的生物相容性介质中的纤维状(同源或异源的)阔筋膜补充面关节的软骨。粒径范围从0.01mm至5mm，优选在0.05和0.25mm之间。使用皮下注射针，通过完整的关节囊直接将悬浮液注射入关节的面关节间隙。注射后悬浮液容纳在关节囊内。随后，介质扩散出盘间隙，把水合的阔筋膜材料留下来。单次注射对于改善面关节结构是有效的，尽管为达到合适的治疗水平可能必需另外的注射。
实施例2
使用水合微粒的凝胶或悬浮液或如水、盐水或乙二醇的生物相容性介质中的纤维状异源环纤维化补充面关节的软骨。粒径范围在从0.01mm至5mm，优选在0.05和0.25mm之间。使用皮下注射针，通过完整的关节囊将悬浮液直接注射入关节的面关节间隙。注射后悬浮液容纳在关节囊内。随后，介质扩散出盘间隙，把水合的阔筋膜材料留下来。单次注射是合乎需要的，然而，为达到合适的治疗水平可能必需另外的注射。
实施例3
使用细粒、微粒或粉末状的脱水环纤维化材料补充面关节的软骨。粒径范围0.01mm至5mm，优选在0.05和0.25mm之间。该材料以脱水状态装填入为输送微粒物质而特别设计的注射器中。通过一个小的、扩张的囊开口将材料挤压进关节的面关节间隙。在注射器针去除之后，该材料保留在关节联接的面关节间隙内。随后它吸收水分或体液并在体内膨胀。
虽然在附图和前述中详细阐述和说明了本发明，但同样被认为是阐述性的，其特征并不受限制，可以理解的是，仅显示和描述了优选实施方案，并且在本发明的精神内的所有变化和改进都要求保护。

Claims (37)

1.一种包含微粒状基于胶原的材料的均匀组合物在制备治疗滑膜关节的药物中的应用，其中所述的微粒通过外科手术添加到滑膜关节处，其中所述的微粒为脱水形式，并在手术植入滑膜关节后再水化，或者所述的微粒为水化形式。
2.如权利要求1所述的应用，其特征在于，所述的包含微粒状基于胶原的材料通过注射和/或挤压外科手术添加到滑膜关节。
3.如权利要求1所述的应用，其特征在于，所述微粒的大小在0.05mm至5mm范围。
4.如权利要求1所述的应用，其特征在于，所述微粒的大小在0.05mm至3mm范围。
5.如权利要求1所述的应用，其特征在于，所述微粒的大小在0.05mm至1mm范围。
6.如权利要求1所述的应用，其特征在于，所述微粒的大小在0.25mm至1mm范围的微粒。
7.如权利要求1所述的应用，其特征在于，所述微粒的大小在0.05mm至20mm范围的微粒。
8.如权利要求1所述的应用，其特征在于，所述基于胶原的材料以水化形式作为凝胶或浆注射。
9.如权利要求1所述的应用，其特征在于，所述基于胶原的材料作为溶液或悬浮液注射。
10.如权利要求1所述的应用，其特征在于，所述基于胶原的材料作为另外包含促进胶原分子交联的交联剂的配方提供。
11.如权利要求1所述的应用，其特征在于，所述基于胶原的材料作为另外包含放射造影剂的配方提供。
12.如权利要求1所述的应用，其特征在于，所述基于胶原的材料作为另外包含镇痛药的配方提供。
13.如权利要求1所述的应用，其特征在于，所述基于胶原的材料作为另外包含抗生素的配方提供。
14.如权利要求11-13任一所述的应用，其特征在于，放射造影剂、镇痛药或抗生素均匀地分散在基于胶原的材料中。
15.如权利要求1所述的应用，其特征在于，所述基于胶原的材料作为另外包含多糖的配方提供。
16.如权利要求15所述的应用，其特征在于，所述多糖是蛋白聚糖。
17.如权利要求15所述的应用，其特征在于，所述多糖是透明质酸。
18.如权利要求1所述的应用，其特征在于，所述基于胶原的材料作为另外包含生长因子的配方提供。
19.如权利要求1所述的应用，其特征在于，所述基于胶原的材料作为另外包含一个或多个其它类型的细胞的配方提供，所述细胞有效地促进愈合、修复、再生和/或恢复滑膜关节，和/或促进正常的关节功能。
20.如权利要求2-13，15-19中任一项所述的应用，其特征在于，所述滑膜关节是面关节。
21.如权利要求14所述的应用，其特征在于，所述滑膜关节是面关节。
22.一种滑膜关节，它包括包含微粒状基于胶原的材料的均匀组合物，其中所述的微粒通过外科手术添加到滑膜关节处，其中所述的微粒为脱水形式，并在手术植入滑膜关节后再水化，或者所述的微粒为水化形式，其中所述微粒的大小范围为0.05-20mm。
23.如权利要求22所述的滑膜关节，其特征在于，所述基于胶原的材料包括大小在0.05mm至5mm范围的微粒。
24.如权利要求22所述的滑膜关节，其特征在于，所述基于胶原的材料包括大小在0.1mm至5mm范围的微粒。
25.如权利要求22所述的滑膜关节，其特征在于，所述基于胶原的材料包括大小在0.5mm至5mm范围的微粒。
26.如权利要求22所述的滑膜关节，其特征在于，所述基于胶原的材料以水化形式作为凝胶或浆注射入关节。
27.如权利要求22所述的滑膜关节，其特征在于，所述基于胶原的材料作为溶液或悬浮液注射入关节。
28.如权利要求22所述的滑膜关节，其特征在于，所述基于胶原的材料作为另外包含促进胶原分子交联的交联剂的配方提供。
29.如权利要求22所述的滑膜关节，其特征在于，所述基于胶原的材料作为另外包含放射造影剂的配方提供。
30.如权利要求22所述的滑膜关节，其特征在于，所述基于胶原的材料作为另外包含镇痛药的配方提供。
31.如权利要求22所述的滑膜关节，其特征在于，所述基于胶原的材料作为另外包含抗生素的配方提供。
32.如权利要求22所述的滑膜关节，其特征在于，所述基于胶原的材料作为另外包含多糖的配方提供。
33.如权利要求32的滑膜关节，其特征在于，所述多糖是蛋白聚糖。
34.如权利要求32的滑膜关节，其特征在于，所述多糖是透明质酸。
35.如权利要求22所述的滑膜关节，其特征在于，所述基于胶原的材料作为另外包含生长因子的配方提供。
36.如权利要求22所述的滑膜关节，其特征在于，所述基于胶原的材料作为另外包含一个或多个其它类型的细胞的配方提供，所述细胞促进愈合、修复、再生和/或恢复所述的滑膜关节，和/或促进正常的关节功能。
37.如权利要求22至36中任一项所述的滑膜关节，其特征在于，所述滑膜关节是面关节。
CNB2003801033159A 2002-11-15 2003-11-10 包含微粒状基于胶原材料的组合物的制药应用和包含所述组合物的滑膜关节 Expired - Fee Related CN100394989C (zh)

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