CN1149498A - 医用材料及其制造方法 - Google Patents
医用材料及其制造方法 Download PDFInfo
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- CN1149498A CN1149498A CN96106209.6A CN96106209A CN1149498A CN 1149498 A CN1149498 A CN 1149498A CN 96106209 A CN96106209 A CN 96106209A CN 1149498 A CN1149498 A CN 1149498A
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Abstract
通过本发明获得一种医用材料,这种材料应用于外科手术时,具备生物相容性,且保持充分的强度,可用于制造创伤填补材料、创伤缝合材料、人造器官等,在实质上只含有生物体***膜结构的致密层的膜状物中浸渍胶原或明胶,用物理或化学方法使其结构蛋白质分子间形成交联结构,得到具有强韧的物性且具备生物相容性的医用材料。
Description
本发明涉及适用于外科手术的生物体用人造材料,更具体地是有关创伤填补材料、创伤、烧伤、烫伤的保护材料、供者植皮部位的皮肤移植(donor site.skingraft)及属于人造器官能范畴的各种用于治疗的医用材料及其制造方法。
在使用上述材料的产业领域,至今为止使用的是制成各种形状的多种合成或天然高分子材料,也同样使用以马、猪、牛的生物体结构片(biogenic portion)为原料的医用材料。这些用现有的技术生产的医用材料,对于人体都是异物或者是异种的医用材料。因此用这些现有的技术生产的医用材料应用于人体时,不能完全消除免疫反应、异物反应等的不良作用。
将取自于人尸体的作为***膜的一种的硬脑膜冷冻干燥制成医用材料。这种冷冻干燥的硬脑膜是唯一被认可为同种的置换用创伤填补材料的医用材料。但是,因其为含有构成***膜的上皮层、纤维母细胞层等的细胞质的医用材料,近期指出这种材料存在有严重的副作用及与传染性疾病克罗伊茨费尔特-雅各布综合征的病原体朊病毒有关。
其他还有天然高分子材料、合成高分子材料的医用材料以及将马及猪的心包用戊二醛进行彻底的化学修饰使其成为在生物体内不溶解、不被分解、不被吸收的具有与合成高分子材料几乎相同性状的用于生物体内植入的医用材料。这种材料埋入生物体后,生物体有通过排异反应进行自我防御的生理现象,这种材料被内皮细胞包裹,包裹层逐步肥厚、肥大,永久残存。这种对于生物体属异常的现象,当然与埋植部位周围的正常组织的生存、生长不协调,产生不适,有可能发生不适当的情况。
本发明人及/或本发明的合作研究人员等从1983年1月(昭和58年)到现在,一直进行有关该项技术的研究,最先提出了各种专利申请,这些现有的技术如下所述。
日本专利第1641621号是有关使用由天然高分子纤维或合成高分子纤维与人羊膜形成的复合材料制成的膜状、管状的医疗器具,这种器具用于修复膀胱、尿道、输尿管。基于这项发明的医用材料,不仅没能完全解决抗原性、***反应等生物相容性,而且还有在生物体内不能被分解吸收而作为异物残留于生物体内的缺点。
特开平7-116242号公报记载的发明是关于一种医用材料的发明,其特征是,在两张胶原样膜中间夹入网状中间材料用粘合剂使之紧密粘合。即关于使用由胶原样膜和合成纤维形成的网状中间材料的复合材料的医用材料的发明。此处,“胶原样膜”包括硅酮膜、明胶膜、其他的天然高分子凝胶膜、合成高分子凝胶膜。而且“胶原样膜”不是科学术语,是极含糊的用语。此发明仍存在合成纤维特有的异物反应(foreign-body reaction)。
专利公开号为95-7-213597号(特开平7-213597)的“发明名称”是“精制胶原样物质”。其说明书中的实施例1将精制胶原样物质明确记载为人羊膜致密层。此项发明是关于一种由人羊膜致密层制成捻线(twisted thread)及由捻线制成的成形产品的医用材料及其制造方法。此项专利申请的技术,材料的物性由只存在于基质材料的胶原分子间的交联密度决定,因此缺点是物理强度不足。
上述目前正在使用的医用材料,不足之处在于应用于生物体有某种危险和/或不具备外科手术操作要求的物性条件。本发明的目的在于提供一种具备安全性、有效性及实用性的最理想的医用材料。最理想的用于治疗的外科手术领域的医用材料要同时满足下列与安全性、有效性及实用性相关的各项条件。
(1)安全性:作为体内植入用品,治疗骨/组织的材料需与生物体长期接触(30天以上)的情况下,必须用基于国际标准化组织(International Organization for Standardiztion ISO)制定的方针的实验方法实施这些材料的细胞毒性、致敏性、亚急性毒性、植入及其他实验,且必须证实其符合制定的安全性要求。此外还必须依照基于法规为该医疗器具制定的安全标准,用有关化学实验、物理实验、生物学实验的复杂的范围广泛的细则制定的实验方法进行实验,证实其符合所制定的安全性要求。有关表面接触用品的ISO方针,按接触部位分类为皮肤、粘膜、损伤表面,分别制定各自的实验项目、实验方法及评价标准,要求证实其安全性。此外还必须满足法规制定的该医疗用品的安全性标准。来源于生物体组织的医用材料,满足以上标准之外,还必须完全排除应用于治疗时源于病原体的危险,如肝炎(甲型、乙型、丙型)、HIV、性病等传染性病原体病毒、细菌及克罗伊茨费尔特-雅各布综合征的传染性病原体朊病毒等,从而具有安全性。(2)医用材料用作创伤填补、保护材料时的有效性:具备物理、机械功能的同时,还必须满足生理功能的要求,否则不能认定其为最理想的医用材料。这种最理想的物理、机械功能的条件是指适用于该缺损患部的医用材料用任何方法都能使用,如用粘合剂的粘合法、手缝合、器械缝合等。且能粘合固定切除、去除缺损患部后的正常组织、脏器以及具有与正常组织、脏器的物理、机械的功能协调一致的性质。
上述生理功能最理想的条件是指同时满足下列条件:
①医用材料为同种材料
②应用于生物体外科手术部位时,在适宜条件下经一定的时间随着医用材料被分解、吸收与正常组织置换。
③阻止外科手术部位血液、体液的渗出、漏料及气体的漏出。
④不需要引流术
⑤具有适宜的物性及物理、机械强度。
⑥使外科手术操作容易进行,使手术时间缩短及早期愈合成为可能。
上述条件①、②两项的机理简要说明如下。***学有关于“细胞增殖和细胞外基质”及“创伤愈合和细胞外基质’的基本理论。是关于生物体通过细胞增殖形成组织的自我修复创伤部位的生理机制的机理。生物体的***是由上皮层、基膜层、致密层及纤母细胞层按顺序形成的叠层结构的层。人们认为***的形成机制是该***特有的细胞生长附着于致密层。生长附着的细胞增殖逐渐形成其他层从而形成为***。这种细胞增殖的必要条件被认为是由构成致密层的各型胶原形成的胶原纤维形成适宜的基质以及细胞生长因子物质的存在。基于这种学术理论,满足最理想生理功能条件的医用材料为同种材料即完全保持了由构成人的***的各型人胶原形成的致密层基质的医用材料。
(3)实用性:开发医用材料的目的在于为患者服务以及提高医疗福利水平。即最理想的医用材料是满足能早日治愈疾病、能使患者早日出院、能缩短外科手术时间(方便外科大夫)、定量稳定地供给(福利上的公平)、质量规格的长期稳定及合理的价格等条件的具有实用性的医用材料。
对照上述最理想的医用材料必备的理想条件,基于现有技术的医用材料还存在下述根本上的、本质上的缺陷。
①作为天然或合成高分子材料的医用材料以及在生物体内不溶、不分解、不被吸收、与合成高分子具有相同性状的以戊二醛完全化学修饰的马和猪的心包为原料制成的生物体植入用医用材料等在生物体内因为有通过异物反应进行自我防御的生理现象,被内皮细胞包裹,包裹层逐渐肥厚、肥大,永久残存。这种对于生物体来说异常的现象,自然与植入部位周围的正常组织的生存、生长不协调,产生不适感,不能排除发生不良情况的危险。
②被批准为同种置换用创伤填补材料而在市场上销售的以人尸本硬脑膜为原料的冷冻干燥硬脑膜,不能排除传染性病原体朊病毒引起疾病的在治疗上的疑虑、供给量不稳定以及价格昂贵等缺陷。
③现在市场上销售的医用创伤保护材料有猪皮、塑料薄膜、纤维状褐藻酸无纺织布及其他各种各样的产品。这些都在愈合的创面上残留瘢痕疙瘩、伤痕。由于生物体的异物反应在治愈之前必须进行1次以上的贴换、更换,在最理想的创伤保护材料发明之前,最终也只能是单纯的代用品。
④由牛、猪的皮肤的真皮层提取、精制的I型胶原,使用除去其尾肽(telo peptide)部分的胶原作为医用材料。使用这种胶原的医用材料,具有下述缺点,采用工业上的手段、技术不能完全消除抗原性;未形成作为***再生必要条件的细胞外基质因而不具备再生的生理功能;是用戊二醛等进行完全化学修饰的合成高分子化合物,在生理学上与塑料类似;以及存在对慢病毒例如艾滋病毒及传染性病原体朊病毒的疑虑。这些材料也只是目前的代用品。
⑤动物的肠壁制成的缝合线符合在生物体内有分解、吸收性的要求,但除存在上述胶原未解决的病原体问题之外,还存在瘢痕疙瘩、伤痕等问题。多羟乙酸(略为PGA)线制成缝合线、PGA网及用PGA线制成无纺布等作为能在体内分解、吸收的医用材料在市场上销售,但因是糖类还存在***反应、刺激性的问题。
⑥本发明申请人首先提出的专利申请95-75914号(特愿平7-75914)及专利申请95-75915号(特愿平7-75915)中记述的发明是关于用在生物体内具有分解、吸收性的合成高分子纤维强化实质上构成生物体组织的致密层膜的物理性质得到的纤维强化医用材料及其制造方法。专利申请(特愿平7-75914)及专利申请95-75915(特愿平7-75915)中记述的发明,以该合成高分子纤维作为医用材料使用,但并没有完全解决***反应、刺激性、抗原性等与生物相容性有关的不妥问题。
本发明欲解决的课题是全部解决上述现有的技术遗留的各种因素引起的问题,开发满足上述最理想条件的医用材料。
所以本发明人认为应开发能解决上述课题的最好的医用材料,研究的结果完成了本发明,其要旨在于只在构成生物体***的无细胞质层(实质上是致密层)的膜状物中浸渍胶原或明胶形成膜材,通过在构成膜材的蛋白质分子间实施物理或化学交联反应,得到可用于外科手术中手缝合及器械缝合、具有强韧物性的膜状医用材料以及由这种膜状材料制成医用线状(thread)或带状(string)物及由这些线状及带状物制成的医用管状物、软管状物及这些用品的制造方法。
***在生理学上按功能(function)分类,在结构形态上分为上皮层、基膜层、致密层、纤维母细胞层四层。光学显微镜学上,按视觉所见分类,结构上分为上皮层、基膜、纤维母细胞层三层。即光学显微镜学上将生理学上分类为基膜层和致密层的结构总称为基膜。另外上皮层、纤维母细胞层是细胞质层,基膜层、致密层是无细胞质层。基膜层是厚度以纳米为单位表示的超薄层,致密层厚度可用微米表示。
本发明所指***包括硬脑膜、心包、胸膜、***、膈、腹膜、筋膜、肠系膜、皮肤、鼓膜、其他的生物体膜及血管壁、食道壁、气管壁、尿道壁、输尿管壁、心脏壁、其他的生物体脏器的外壁,还包括胎膜及构成胎膜的羊膜、绒毛膜。人羊膜厚度为12000nm,以基底层(厚50~80nm)、致密层(厚8000~10000nm)为界在其两侧外面形成上皮层和纤维母细胞。本发明所说致密层是光学显微镜下致密层和基膜的综合体,实质上是指生理学领域的致密层。
实施本发明时使用的膜状物只是构成***的无细胞质层,实质上是致密层,是生理功能及生物相容性满足最理想条件的医用材料。但是其物性与糯米纸的物性类似,尤其是湿润时,极度收缩且很软,不仅不能缝合,而且被体液浸湿后外科手术操作极难进行。
构成作为***的人羊膜、人绒毛膜的致密层中,I、III、V型胶原排列成纤维状形成基质。本发明的发明人及合作研究者们还发现了XVI型胶原的存在,发表在J.Biochem.,112,856-863(1992)。即可以说致密层主要由胶原物质构成。因此,致密层具有胶原特有的化学性质。
加热、电子射线照射、放射线照射等物理能量能使胶原分子间发生交联反应,称之为胶原的物理修饰。甲醛、戊二醛等化学试剂也能使胶原分子间发生交联反应,称为胶原的化学修饰。这种胶原的物理修饰或化学修饰使胶原发生分子间交联反应,被认为是作为胶原分子的侧链基团的氨基之间发生的交联反应。
胶原分子间的交联反应,能提高胶原组成物的强度。但是即使作为胶原组成物的致密层膜的胶原分子中存在的氨基官能团全部发生交联反应,如果不进行纤维强化,致密层膜的物理修饰物及化学修饰物也不具有适用于外科手术操作的缝合及其他手术操作的物性。原因在于形成致密层的胶原分子中存在的氨基官能团的数量决定了交联密度的不足。
明胶与胶原物性不同,但同为化学组成相同的蛋白质。因此明胶与胶原相同也含有氨基官能,也可通过物理、化学修饰使在蛋白质分子间发生交联反应。
本发明未使用与构成致密层膜的物质不同质的化学物质,得到使用具有能满足外科手术条件的物性及强度的致密度膜的医用材料。
本发明中所说的胶原是指来源于动物的经过提取、精制的胶原,并去除了胶原的尾肽。优选来源于人的经过提取、精制的胶原,更优选来源于人胎膜的胶原。
本发明中所说的明胶,是日本药典方所载注射用精制明胶,特别优选与来源于人的胶原的药典方注射用精制明胶具有同等质量的明胶。
通过实施本发明,在致密层膜中浸渍胶原或明胶,然后致密层膜的胶原分子间发生交联反应的同时,浸渍的胶原或明胶的蛋白质分子间也发生交联反应,由此使膜材料的蛋白质分子间的交联密度能极大地提高,膜材料的物理强度能得到明显加强。
结果本发明得到的膜材料,与只有致密层发生交联的膜材料相比,其物理强度显著提高。如实施例1所示,这些实验结果中的一例如表1所示。
表1
厚度(μm) | 抗拉强度(Kgf/cm2) | 伸长率(%) | |
(1)未处理的致密层膜 | 4.5 | 470 | 13.7 |
(2)交联的致密层膜 | 4.1 | 300 | 8.8 |
(3)交联浸渍明胶的致密层膜 | 14.0 | 631 | 5.0 |
由以上工序制造的本发明的医用材料,不仅使外科手术操作中的手缝合及器械缝合成为可能,而且在被血液、体液浸湿时也能保持原来形状,具有容易操作的特点。所以作为膜状的医用材料,在作为埋入生物体内的创伤填补材料、创伤修补材料及外用创伤保护材料、烧伤保护材料、烫伤保护材料、皮肤移植的移植供皮等使用时具有实用性。作为线状医用材料可用作缝合线,制成软管状、管状的医用材料可应用于人造血管、人造输尿管、人造尿道、人造气管、人造食道等方面。
下面通过实施例进一步详细说明本发明。
实施例1
称取日本药典方注射用精制明胶2g,溶于60℃的药典方精制水100ml中,冷却至室温。以下称之为明胶水溶液。将明胶水溶液注入尺寸为30cm×15cm×2cm(高)的盘内,注入高度为1cm,保存在室温下。将直径3cm长10cm的陶瓷制滚子浸于上述盘内的明胶水溶液中,使滚子转动,明胶水溶液附着于滚子表面。
将致密层膜平铺在厚5cm×宽30cm×长50cm的聚乙烯板上,静置。在致密层全表面上转动附着明胶水溶液的滚子,将明胶水溶液滚压入致密层膜。反复进行这项操作,使致密层膜中浸渍明胶水溶液直至达到饱和状态。浸渍了明胶水溶液的致密层膜经连续减压吸引,在105℃的条件下加热干燥24小时,使发生交联反应。
为解决对残存的未反应的氨基引起的抗原性的担心,对交联处理后的膜材料进行下述的琥珀酰化反应处理。按每500ml PH为9的0.02M硼酸缓冲液加入100ml的无水琥珀酸的5%丙酮溶液的比例混合得到琥珀酰化调整液。将交联处理过的膜材料浸于装满琥珀酰化调整液。将交联处理过的膜材料浸于装满琥珀酰化调整液的容器中放置4小时后,用药典方精制水洗涤,除去琥珀酰化调整液,在减压干燥装置内,于30℃干燥,用无菌暖风干燥约12小时,得到本发明的目标产品。其物性示于表1。
通过以上的工序得到本发明所希望的具有交联结构的医用材料。用茚三酮法检查得到的膜材料,结果未呈显色反应。因此证明了构成致密层膜的胶原分子间的交联反应及浸渍的明胶分子间的交联反应彻底完成以及不存在未反应的氨基。
实施例2
下面说明浸渍胶原的实施例。用加入了高研株式会社生产的商品名为高研(Koken)Atherocollagen Implant3%溶液1ml的胶原或者按照讲谈社株式会社发行的《胶原实验法》第1章“胶原的制备”中记载的极一般的制备法配制来源于人羊膜、绒毛膜的0.004%的人型胶原中性缓冲水溶液。以下称之为胶原溶液。除用上述胶原溶液代替实施例1中使用的明胶水溶液之外,其余操作同实施例1,得到本发明的目标医用材料。
作为示例,对由实施例1得到的本发明的医用材料的物理修饰膜在兔背部肌肉内的吸收和组织反应方面的实验结果示于表2、表3。
表2来源于人羊膜致密层膜的物理修饰膜在兔背部肌肉内的吸收
2wk | 4wk | 6wk | |
物理修饰的致密层膜 | 膜脆化 3/5膜断裂 2/5 | 膜吸收 3/4膜部分残留 1/4 | 膜吸收 2/3膜部分残留 1/3 |
8wk | 12wk | 16wk | |
物理修饰的致密层膜 | 膜吸收 3/3 | 膜吸收 3/3 | 膜吸收 3/3 |
表3来源于人羊膜致密层膜的物理修饰膜在兔背部肌肉内引起的组织反应
2wk | 4wk | 6wk | |
物理修饰的致密层膜 | 炎症细胞浸润轻度 2/5中度 3/5 | 炎症细胞浸润轻度 4/4 | 炎症细胞浸润轻度 3/3 |
8wk | 12wk | 16wk | |
物理修饰的致密层膜 | 炎症细胞浸润轻度 1/3无 2/3 | 脂肪组织部分纤维组织 3/3 | 脂肪组织部分纤维组织 3/3 |
以上的结果证明由本发明得到的医用材料在生物体内的吸收性良好,而且应用于生物体组织具有很高的安全性。
Claims (4)
1.一种可用于外科手术中的用手缝合及器械缝合的具有强韧物性的膜状医用材料,其特征在于,该膜状材料只由非细胞质层构成或实质上是生物体***膜结构中的致密层,在其中浸渍胶原或明胶,在结构蛋白分子之间进行物理的或化学的交联反应。
2.一种线状(thread)或带状(String)的医用材料,其特征在于,在只由非细胞质层构成的或实质上是生物体***膜结构中的致密层中浸渍胶原或明胶制成膜材料,由该膜材料制成线状或带状的医用材料,通过在结构蛋白质分子间进行了物理的或化学的交联反应,可以稳定地保持线状或带状的形状且具有强韧的物性。
3.一种管状或软管状的医用材料,其特征在于,在只由非细胞质层构成的或实质上是生物体***膜结构中的致密层中浸渍胶原或明胶制成膜材料,由该膜材料制成线状或带状的成形物,再由该成形物制成管状或软管状的成型体,通过在结构蛋白质分子间进行了物理的或化学的交联反应,可以稳定地保持管状或软管状的形状且具有强韧的物性。
4.权利要求1~3中记载的医用材料的制造方法,其特征在于,将来源于生物体的致密层中浸渍胶原或明胶后制成膜状物、线状物、带状物、管状物、软管状物,然后通过加热或紫外线照射、电子射线照射、放射线照射等照射使其发生物理交联,或者用醛类等化学试剂使其发生化学交联反应。
Applications Claiming Priority (2)
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JP7305259A JPH09122227A (ja) | 1995-10-31 | 1995-10-31 | 医用材料およびその製造方法 |
JP305259/95 | 1995-10-31 |
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CN1149498A true CN1149498A (zh) | 1997-05-14 |
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CN96106209.6A Pending CN1149498A (zh) | 1995-10-31 | 1996-05-08 | 医用材料及其制造方法 |
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US (1) | US5618312A (zh) |
EP (1) | EP0773032A1 (zh) |
JP (1) | JPH09122227A (zh) |
CN (1) | CN1149498A (zh) |
CA (1) | CA2173546C (zh) |
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US5618312A (en) | 1997-04-08 |
CA2173546A1 (en) | 1997-05-01 |
EP0773032A1 (en) | 1997-05-14 |
JPH09122227A (ja) | 1997-05-13 |
CA2173546C (en) | 2000-03-14 |
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