CN1033560A - 替代牙齿或部分骨组织的植入物 - Google Patents

替代牙齿或部分骨组织的植入物 Download PDF

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CN1033560A
CN1033560A CN88104540A CN88104540A CN1033560A CN 1033560 A CN1033560 A CN 1033560A CN 88104540 A CN88104540 A CN 88104540A CN 88104540 A CN88104540 A CN 88104540A CN 1033560 A CN1033560 A CN 1033560A
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glass
bone
implant
metal
absorbable
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安蒂·伊利-厄普
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ANTTI YLI URPO
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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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    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0012—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy
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    • A61C8/0018—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the shape
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    • A61C8/0013—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy with a surface layer, coating
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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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Abstract

用于代替牙齿或部分骨组织的植入物，它含有金 属部分(1)(需要强度时)，用附着于该金属的含金属 氧化物添加物的不可吸收的生物玻璃，即Ca-P玻璃 罩住；此外，该植入物含有可吸收到骨或生物体上的 Ca-P玻璃混合物，HA已被加到可吸收的(4)和不 可吸收的(2)Ca-P玻璃中，使(2)和(4)彼此之间，以 及与组织、与金属(1)附着连接。并且在(2)和(4)之 间加入缓慢可吸收的Ca-P玻璃和HA的混合物 层。不需要高强度时，金属芯核可由不可吸收的 Ca-P玻璃代替。

Description

尽管研究人员一直对把合成材料植入组织中很感兴趣，但是直到十八世纪末人们才第一次实现了这一尝试。然而，这些研究并未带来任何令人满意的结果。事实上，自50年代初以来，在将钛或钽金属片装入骨、如颌骨中已取得了不同的成功。
由于手术的难度和感染的危险，大的骨膜下结构和骨内膜（endosteal）片愈来愈不受欢迎。它们已被单独的螺杆（Branemark，Straumann，Bioceram;参考文献1    Albrektson等人，Special    reprint，The    long    term    efficacy    of    Currently    used    dental    implants.A    review    and    proposed    Criteria    of    Success.Int，J.Oral    and    Max.fac.Implants    1.1986）和像单独一个牙根的大的园锥柱体（Frialit;ref.1.）代替。对于本方法来说，把该结构放入牙槽骨中是共同的。这样，有可能在骨与植入物之间实现机械接触。该植入物还穿入齿龈，留下凸出的可见部分，这个突出部分对假体起支承作用。为了防止细菌侵袭，上皮必需紧密地附着于该突出部分的表面。为此，要求总保持该区域清洁。
上述方法中植入物与骨头的附着由于感染的组织层而被阻止，可以用两期手术的方法来避免这个问题，在该方法中，在第一期中，植入物被全部螺旋旋入该骨内（ad    modua    Branemark，ref.1）。在手术的第二期里，在3～6月后，该植入物上安上一个凸出部分。其结果是令人满意的。
已经提出了这种方法的几种变型（IX-植入，IMZ-植入，芯-管-植入（Core-Vent-implantat））。所用的材料是钛或是具有等离子喷涂（TiO2）Ti的钴-铬合金。尽管制造商保证可以在手术后立即装入，但是愈合期在3至6个之间。其主要缺点是该方法困难且复杂。
Straumann的方法更为简单，但较不可靠。在该方法中，空心穿孔柱体从牙龈突出并只用一次手术被装入骨内。该材料是Co-Cr合金，它是通过等离子喷涂涂上TiO2的，这些园柱体由于它们的不可靠性而在1986年从市场上被撤消。
目前，第三类植入物是多晶Al2O3-陶瓷，Frialit植入物，它在牙齿拨出后被直接装入被扩大的根腔里。在形状方面，这种植入物朝向其终端以几个阶跃变化缩小。由于陶瓷的脆性，这些植入物只能用于支承像门牙这样咬合压力小的单个牙齿。
日本的“生物陶瓷”Kyoceranas植入物的Al-Crystal-Saphire植入物系列，它们比Frialit植入物更少些。这些植入物强度高，但延性低。而且，由于该材料的脆性，必须非常小心地进行退火处理。获得的临床效果与制造商给出的结果不相吻合。骨头与生物陶瓷的附着似乎不能令人满意。其原因可能是其惰性性质和其表面的低摩擦以及表面面积小。
即使一个长的愈合期似乎也不足以产生一个坚固的附着。
大而简单的附着机制所要求骨的最小尺寸是深10mm和宽5.5mm（Straumann），拨走牙齿后，牙槽骨收缩，使得没有足够的骨头用于安装这样的植入物。
因为薄结构不能承受所需要的机械应力，所以钛和Al2O3植入物两者都太大。此外，Ti的制造困难。另一方面，小的植入物（Branemark）复杂而昂贵，最小的非金属（生物陶瓷）植入物则具有脆性。
所使用的材料类型可以以下面的方式分类：
1.生物不相容的金属：
Co-Cr合金，不锈钢，镍合金，第Ⅳ族的贵金属
2.惰性材料，它与组织不反应，但与骨头得到紧密的接触：
Al2O3陶瓷，Ta和Ti金属和它们的合金（TiV4A16），各种不同形态的碳，聚四氟乙烯。
3.生物活性材料，它们积极、迅速地与骨头附着，即它们是有表面活性的，能诱导骨的生长：
羟基磷灰石（hydroxylapatite），Ca-P玻璃，Ca-P玻璃陶瓷，“生物陶瓷”。磷酸三钙，即TCP（吸收即溶解到组织中），其组分和制造方法使这些材料产生吸收性，并从完全可吸收到不可吸收各不相同。
下表表示了所用的材料和它们的性质。
材料 10N/mm2骨结合 与上皮
强度＊的结合
Al生物陶瓷材料    9-7/7-4    ++    ++
CaP-生物陶瓷材料    9-0.5/2-0.5    ++    ++
羟基磷灰石    0.5/0.5    +++    +
钛    99.9    6/5    +    +
Ti-6Al-4V    7/6    ±    ±
Ti-6Al-4V+生物涂层    7/6    ++    +
钢    9.75/7.5    --    --
钴-合金    8.5/7    -    -
碳    5.5    +    +
塑料（含钙）    1-0.5    ±    ±
贵金属    8.1/5.8-    ±    ±
8.8/8.4
钽    +    +
＊抗拉强度/断裂应力
+++    与骨头和上皮的连接很好，而且还引起骨生长
++    与骨头的连接很好
+    与骨头的连接良好
±    与骨头的连接不大明确
-    没有连接
--    杂粒反应（foreign    particle    reaction）
目前，使用这些生物活性材料的场合如下：
1.羟基磷灰石（HA）与金属的结合是有疑问的。一直想得到一个机械关节，但由于HA的脆性而成问题，没有得到令人满意的结果。也尝试了等离子喷涂，但是，晶体结构被保留、而其表面被转化成易吸收的TCP得不到证实，所以该关节是不耐久的（World    High    Tec，Congress，Milano    1986）。而且，以珊瑚为基础的HA不比任何合成材料更好。然而HA是一种廉价材料，其上面的胶原纤维与组织很好地附着与矿化（Jarcho    et    al.Several    Studies，ref.2    de    Putter，de    Lange，de    Groot：Permucosal    dental    implants    of    dense    Hydroxylapatite    Fixation    in    alveolar    bone;Abstract：Int.Congress    on    tissue    integrationin    oral    and    maxillofacial，Brussels    1985）。
2.Cap-玻璃和玻璃陶瓷，即所谓的生物陶瓷已被观察到具有良好的骨连接能力（Hencke el al.1971，ref.3.Gross et strung：the interface Of various glasses and glassceramics with a boney implantation bed.J.Biomed.Mat.Res.251-271;19，1985）。该反应是以生产富SiO2层和Ca与P的沉积为基础。然后，Ca和P结晶成为附着于表面的胶原纤维周围的HA。
一个理想的方法将要满足以下的要求：
1.植入物必须小而坚固，并完全是生物相容的。
-于是有弹性的钛和可能有过敏反应的镍和铬合金都是不可行的。
-剩下可供选择的材料是相当贵重的合金（Au-，Pt-，Pd-合金）
或者硬钛合金。
2.植入物必须具有能与骨和上皮结合的表面，而且必须对骨生长有加强作用。
这样一些表面是：
-HA＝羟基磷灰石
-TCP＝磷酸三钙
-生物玻璃或生物玻璃陶瓷
目前，为了得到足够小的尺寸和高的强度，一些植入物具有一个金属芯核，该芯核涂敷一种生物玻璃（Cap-玻璃），该生物玻璃由于其含有金属氧化物而不可吸收。此外，它具有一个由Ca-P-玻璃组成的外层，它对骨或生物体是可吸收的（ref.US.Pat.4497629.Ogino    et    al.）。这样，要求1和2从表面上看是满足了，然而，随着外层被吸收，内层不能达到与组织的满意结合。
用羟基磷灰石（HA）已改进了牙植入物的附着作用，在本发明中，HA既被用在可吸收的外层（可吸收的Ca-P玻璃+HA），也被用在于缓慢吸收的内层（可缓慢吸收的Ca-P-玻璃+HA）。此外，用一个中间层加强这两层的连接，该中间层具有一种可调整吸收率的Ca-P-玻璃，并含有HA。通过专利申请中的阐述可基本明了本发明。
以下详细解释了本发明适合于牙齿、即骨内植入物的一个应用（A）。
图1概略地表示了普通使用的材料。
图2表示了用在牙齿里的一个样品结构。
图3表示了一个骨膜下的植入物，即安装在骨和骨膜之间的植入物。
图4表示了一个关节假体。
图5表示一种装入骨腔内的骨内颗粒填料。
图6表示生物陶瓷块的骨补助物。
按照本发明，所示的植入物具有一个硬的表面氧化的金属芯核1（金属陶瓷合金），其热膨胀系数为10-15×10-6/K，涂有一层厚的致密而平滑的不吸收的青铜色生物玻璃，一种Ca-P玻璃和HA的混合物2，它具有9-14×10-6/K的更小的热膨胀系数，它被涂有一层Ca-P玻璃和HA混合物3，烧结成致密的或多孔的、几乎不可吸收的层，其上再涂一层硬度低的Ca-P玻璃和HA的混合物层4，该层是可吸收的，并成为骨头界面的界限，它激活骨的生长，并直接对植入物的连接形成一个机械骨，不会对骨头引起过大的压力。
需要时也可以把外层4做成玻璃的，于是，解决方案是一种层结构，其中外层4可吸收而金属上的内层不可吸收，因为第2层包含吸收抑制物（如金属氧化物），所以吸收无论如何不可能进入到金属表面。按照本发明的说明，在2与4之间存在一个半吸收的界层，此外，在所有的2、3和4的Ca-P玻璃层中加入了HA。这些层（及HA）与金属以及彼此之间的结合由于该玻璃而变得坚固和稳定。特别要指出的是，这样HA也与该金属连接。但是，在大多数情况下，当HA未被加入到该金属表面的层（2）中，或当排除Ca-P-玻璃与HA混合物层时，也可能达到令人满意的稳定的结果。
在不需要该坚固的结构时，就不要金属芯核。例如，当植入物用于骨增长时就可能如此。
就像纯的Ca-P玻璃的比率那样，可以通过控制组分和用添加物（如金属氧化物）来调节玻璃/HA混合物的吸收率。本发明的Ca-P玻璃/HA混合物表面很快（在1-8小时内）与细胞相附着，并由于植入物存在无机物，很快发生矿化现象。
这样的骨连接由于该材料对骨生长的诱导作用可以在软骨（Weakbone）结构中也是坚固的。
这样，这种植入物结构能够做得比以前的小，此外，需要时，该金属芯核支承与之相连的陶瓷结构。通过对该表面上釉，可以防止骨与植入物之间的上皮和疏松结缔组织的推进。本发明以另外的应用可以用不同的结构得到。它们已被表示在下面的表里，对层2、3和4，用了其它合适的组份：
-金属表面可以有一些横槽
-植入物的形状可以是园锥形、园柱形的或螺旋形的，其尺寸可以有所变化：
厚度：例如2.5-70mm
长度：例如7.0-700mm
-愈合期里可以在植入物顶部装上一个陶瓷帽
-植入物可以全部埋入骨中或埋在骨膜下，或者也可以部分地露出在牙龈之外。
本发明骨内植入物的其它应用如下：
B1.安装在骨膜和骨之间的骨膜下植入物。
按照图3，
层1.金属
层2.惰性生物玻璃
层3.HA/生物玻璃混合物
层4.可吸收的HA/生物玻璃混和物
B2.关节假体的那些层与上面是一样的，而且关节表面是惰性致密的碱玻璃陶瓷或金属。
图4中的结构：层1，2，3和4如前一样。
c.骨腔中的骨内颗粒填料。图5，层2、3和4如前一样。在使用填料5时，具有直径在1-5mm之间的大颗粒如：
a.该颗粒的芯核是缓慢可吸收的，其表面则是迅速可吸收的。
b.一部分颗粒是不可吸收的（2），一部分是缓慢可吸收的（3），另一部分是迅速可吸收的。
c.一部分颗粒是缓慢可吸收的（3），而其余或者是迅速可吸收的（2）或者不可吸收的（4）。
d.一部分颗粒或者是缓慢可吸收的，或者是快速可吸收的（4）。
D.骨膜下的和牙周膜的颗粒填料是与前面一样的，但是这些颗粒小，且是缓慢可吸收的。其直径在0.1至1mm之间，没有多层。在c和d情形下，可以是给出所需的与空间一致形状的一个可硬化的塑料。
E.图6表示了颗粒、一个代替骨头的生物陶瓷块的一个整体化的替代物，一个陶瓷块通过或者部分或者全部地具有如图6a所示的Ca-P玻璃/HA混合物的缓慢可吸收的或迅速可吸收的表面层可以与骨头接合。该陶瓷块可以如图6b所示预先与金属部件相连接，该陶瓷块由缓慢可吸收层（3）和不可吸收的（2）Ca-P玻璃/HA混合物材料的上釉层组成。此外，如果希望增强与骨的结合，外表面可以由迅速可吸收的材料（4）组成。

Claims (6)

1、一种用于代替牙齿或骨组织其它部分的植入物，需要强度时有一个金属芯核(1)，它具有附着于该金属上的、由于有金属氧化物添加物而不可吸收的一种生物玻璃，即Ca-P玻璃，此外还具有对骨头或生物体是可吸收的Ca-P玻璃，其特征在于通过将HA加到可吸收的Ca-P玻璃(4)和不可吸收(由于金属氧化物)的Ca-P玻璃(2)以及还可加到缓慢可吸收的这种玻璃中保证了组织与植入物、各层彼此之间以及层与金属的结合稳定性，第二层与第四层之间加入Ca-P玻璃和HA混合物层，这样就可以将该结构既可用在牙植入物中也可用在其它型式的植入物中。
2、权利要求1所述的一个结构，其特征在于其金属芯核全部由不可吸收的Ca-P玻璃来代替，而生物体按照本发明通过将HA加到夹层而与这个芯核结合。
3、权利要求1所述的一个结构，其特征在于当植入物用在关节中时，若关节的骨物质在内侧，则内层（4）是可吸收的Ca-P玻璃和HA的混合物，而外层（2）是不可吸收的Ca-P玻璃层。若关节的骨物质在外侧时，情况正相反。
4、权利要求1所述的一个结构，其特征在于本发明的Ca-P玻璃和HA混合物被用作骨腔中的颗粒填料，于是不论是分层的（5a）或慢吸收的（3）或快吸收的（4）颗粒（5b，bc，5d）在它们被吸收时通过骨而与骨头彼此相连。
5、权利要求1所述的一个结构，其特征在于用来代替骨头的块或者部分地或者全部地由缓慢可吸收的（3）或快吸收的（4）Ca-P玻璃和HA混合物组成。
6、权利要求1所述的一种结构，其特征在于依靠Ca-P玻璃和HA的不可吸收的（2）混合物代替缓慢可吸收的Ca-P玻璃HA混合物，金属部分（1）与骨头附着。
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CN101972174B (zh) * 2010-04-13 2013-12-04 上海池工陶瓷技术有限公司 一种ZrO2-HA复合的口腔种植修复体及制作方法
CN109640888A (zh) * 2016-06-22 2019-04-16 艾斯丘莱普股份公司 优选地用于在骨腔的治疗期间使用的医疗产品、用于生产医疗产品的方法及医疗套件
CN109640888B (zh) * 2016-06-22 2021-11-09 艾斯丘莱普股份公司 优选地用于在骨腔的治疗期间使用的医疗产品、用于生产医疗产品的方法及医疗套件

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JP2642183B2 (ja) 1997-08-20
FI885235A0 (fi) 1988-11-11
KR0126285B1 (ko) 1997-12-18
US5139424A (en) 1992-08-18
FI78232B (fi) 1989-03-31
FI78232C (fi) 1989-07-10
NZ225029A (en) 1990-11-27
NO175736B (no) 1994-08-22
DK631189A (da) 1989-12-14
DK631189D0 (da) 1989-12-14
FI872640A (fi) 1988-12-16
FI89864B (fi) 1993-08-31
FI89864C (fi) 1993-12-10
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DE3886551D1 (de) 1994-02-03
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EP0421987A1 (en) 1991-04-17
IE881813L (en) 1988-12-15
NO895066D0 (no) 1989-12-15
EP0421987B1 (en) 1993-12-22
ES2006980A6 (es) 1989-05-16
KR890701067A (ko) 1989-12-19
IL86702A0 (en) 1988-11-30
HU204689B (en) 1992-02-28
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FI872640A0 (fi) 1987-06-15
ZA884205B (en) 1989-04-26
JPH02503757A (ja) 1990-11-08
NO895066L (no) 1989-12-15
CA1323779C (en) 1993-11-02

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