CN1136817C - 覆盖骨骼缺陷位置的薄膜及其制造方法 - Google Patents

覆盖骨骼缺陷位置的薄膜及其制造方法 Download PDF

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CN1136817C
CN1136817C CNB971121370A CN97112137A CN1136817C CN 1136817 C CN1136817 C CN 1136817C CN B971121370 A CNB971121370 A CN B971121370A CN 97112137 A CN97112137 A CN 97112137A CN 1136817 C CN1136817 C CN 1136817C
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thin film
titanium
foil
film
thickness
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CN1181228A (zh
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弗朗茨・哈斯
弗朗茨·哈斯
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Mke Metall-Und Kunststoffwaren Erzeugungs GmbH
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Abstract

一种薄膜，它用于覆盖骨骼缺陷位置和导引骨骼再生，该薄膜由无弹性、无应力且可连续变形的钛薄膜制成，并具有小于0.025mm的厚度。它在至少一个表面上制成粗糙结构或皱纹结构，并可被切割成多个块件，该块件具有切边毛刺。制造这种薄膜的方法包括：对一钛片进行辊轧，以形成一钛薄膜；用流动酸对该钛薄膜进行化学处理，以腐蚀掉特别在辊轧时产生应力的表面并降低薄膜厚度，从而得到无弹性、无应力和可连续变形并具有小于0.025mm的厚度的钛薄膜。本发明的薄膜及其制造方法具有定位可靠、可适用于各种应用场合以及制造成本低、使用方便等优点。

Description

覆盖骨骼缺陷位置的薄膜及其制造方法
技术领域
本发明涉及一种薄膜，其用于覆盖骨骼缺陷位置(例如骨折、牙槽或类似场合)以及导引骨骼再生。本发明还涉及一种制造该薄膜的方法。
背景技术
为使在缺陷位置再生成骨骼已经公知的是，通过一个薄膜覆盖该缺陷位置，以保护软组织并阻止它长入缺陷位置。还已知的是，那些规定让骨骼重新生长的区域通过一种颗粒物填满，这样设置的空间通过薄膜覆盖住。这些颗粒物大多是羟基磷灰石，以起到“占位功能”的作用，以便用于其上生长的骨骼。薄膜大多用纺织材料制成。同时，人们应用那些经多年证明适于缝合伤口的纤维料。这些织物具有防护的作用，它们被置于所希望的位置处，并通过例如缝合技术固定在那里。但是这种纤维结构的边缘区域(例如在手术期间进行切割操作而产生)和这种纺织材料的机械特性(特别是弹性)在许多应用场合都不是很理想。
DE-PS4302709C1涉及一种覆盖装置，其具有覆盖薄膜，以暂时覆盖一个骨骼生长材料如羟基磷灰石颗粒填充的残缺位置。该覆盖薄膜是柔软的、可弯曲的。并且，为了增加刚性而要求一种覆盖膜，它可以构成牢固的有刚性的钛薄膜，其厚度为0.3至1mm并被打孔。而且对于植入物，钉子、板件或轨道件也通过钛金属应用在外科手术中。这种协调一致性是很突出的，并且特别在采用较小的钛料壁厚时，X射线也不会被明显地遮挡。
中国专利申请93114758.1(公开日为1994年6月29日)提出了一种用于固定在骨组织内的固定元件，并公开了一骨膜板或膜片，以用于加强植入物与生物组织的整合。从其说明书中可以看出，该骨膜板或膜片设置在颧骨和骨膜之间，以起到加强植入物与生物组织的整合以及加强固定的作用。这一点与本发明的薄膜是完全不同的(本发明上述类型的薄膜位于软组织和骨质之间，以用于覆盖缺陷位置，并阻止软组织长入缺陷位置)。另外，该现有技术中的薄膜由用纯钛制成并具有弹性的圆片构成，该薄膜的机械特性(特别是弹性)使得其不利于实现在骨骼上的定位工作，因而不能很好地适用于本发明所述的应用场合。
发明内容
本发明的目的是克服上述现有技术中的缺陷，提供一种特别适合实际应用的改进的薄膜，以用于覆盖骨骼缺陷位置和导引骨骼再生，从而能够在小的区域中(例如颌骨手术中)加以应用，并具有定位可靠、使用方便等特点。另外，本发明的目的还在于提供一种工艺简单、制造成本低的制造上述薄膜的方法。
这一目的如此实现：即本发明提供的薄膜由无弹性、无应力和可连续变形的钛薄膜构成，它具有小于0.025mm的厚度，并将至少一个表面制成粗糙的结构或皱纹式结构。
该钛薄膜对于所述的应用目的具有足够的强度且不具有弹性，因为弹性不利于在骨骼上的定位工作。该钛薄膜的被粗糙化处理的或具有皱纹结构的表面，在外科手术应用中起到外侧面的作用，也就是说，作为对着软组织而背离骨骼的侧面。该组织很好地附着在薄膜上。因此，该薄膜的植入例如在牙龈区域内是有利的。上述粗糙化可以通过喷砂或者通过冲制来实现，而皱纹结构通过电腐蚀、激光处理或化学表面加工来完成。一个特别的薄膜实施方案的特征是，它被切割成例如3×4cm的块件，并构成一种切边毛刺，它在所有侧边上伸出薄膜表面。该毛刺按照一个方向定位，并构成一个在骨骼上特有的密封边棱，它可阻止软组织的长入。一个例如由手术线制成的箍带被置于薄膜靠置区域的骨骼上，以确保一个密封的连接。
钛薄膜通过辊轧形成所希望的料厚。该辊轧过程会导致表面结构被压缩，并因此在配合到骨骼上时要产生一弹性作用。这一点当然是不希望的，因为该材料应该是无应力的并保持可变形地位于希望的位置上。
本发明还提供了一种制造上述薄膜的方法，该薄膜由无弹性、无应力和可连续变形的钛薄膜构成，并具有小于0.025mm的厚度，该方法包括以下步骤：对一钛片进行辊轧，以形成一钛薄膜；用流动酸对该钛薄膜进行化学处理。其中，上述化学处可以腐蚀掉特别在辊轧时产生应力的表面并降低薄膜厚度。通过这种化学处理，钛薄膜的边缘层被蚀掉了，亦即去掉了会产生弹性作用的表面层。在达到希望的膜厚后，可以再实行一个清洗过程以及干燥过程，例如在干燥炉中并于100℃的条件下进行处理。通过此步骤，可能的剩余应力也相当程度地被中和平衡掉了。
优选的是，上述方法可进一步包括对所述钛薄膜施加超声波并形成稳定波的步骤。
这种无应力的钛薄膜可以容易地和不可逆地被制成希望的形状。为了外科手术目的，固定这种薄膜时可应用钛钉子，其特征是，该头部是球面形的弯曲结构，并且位于外边的对着杆部的边缘构成一个圆形的靠置边棱或圆环形表面；该头部在球面空腔的内部用一个圆段过渡到杆部上；该杆部具有一个锯齿形的横截面轮廓并由相互连接的截锥形表面构成。该钉子以钉头的外边缘密封地靠置在一个钛薄膜上。通过打入或挤入该钉子，在薄膜中形成一个孔。贯穿该孔的钉子杆部挤压薄膜材料，从而置于钉头部的球面形凹曲的空腔中。为了特别良好的配合作用，从钉头部到杆部的过渡是圆弧结构。该杆部本身通过相互依次连接的截锥表面并以多个倒钩的形式构成。
附图说明
下面结合附图对本发明的实施例进行描述。
图1表明一个通过颌骨的横截面图，其中带有植入物和覆盖膜；
图2是一个骨折缺陷并带有覆盖膜的简图；
图3是制造一个薄膜的方法过程图；
图4是一个用于固定薄膜的钉子局部剖视图。
具体实施方式
按照图1，在颌骨1中钻入一个植入物的第一部分2。上面的开口通过一个螺旋帽4封闭住，在该开口中，在第一部分2牢固植入以后装上一个带牙齿3的第二部分。为了使骨体沿第一部分2纵向拉高，在螺旋帽4和颌骨1之间安置一个外套形的、材料厚度小于0.1mm(此处例如为0.025mm)的钛薄膜5，该钛薄膜5是连续可变形、非弹性和无应力的，它用于阻挡在组织6和颌骨1之间，以防止在颌骨1上增长组织6。而骨体生长在薄膜5和颌骨1之间的空间中，这种骨质生长是在薄膜5的下方很快发生的，因为它不会由于组织6受到阻碍。薄膜5下方的中空腔(如图1中右边所示)可以用羟基磷灰石7填满。它充当“占位功能”，以助于薄膜5下方的骨质生长。该羟基磷灰石7可很快地被生长骨质贯穿并完全地存入骨体中。
不仅在植入物的第一部分2上、而且在颌骨1上都必须使薄膜5形成紧密的连接。为此，薄膜5设有一个小的中央孔，并通过它插入螺旋帽4的杆部。该螺旋帽4呈锥形的结构并安置在植入物的一个锥体上。该薄膜5被夹紧在帽锥体和植入物锥体之间，然后在置入羟基磷灰石7于颌骨1上的情况下铺置为外套形。在颌骨1上的固定通过钉子8实现，其描绘在图4中。该钛薄膜5可以在颌骨1上塑性变形。通过折皱结构可实现该外套形状。该钛薄膜5具有完全非弹性的技术特性，以在上述成形条件下或在适配于植入物和颌骨1时不存在反弹作用。
薄膜5的外表面是粗糙的。因此，组织6可在此产生一个坚固的定位。这种必需的粗糙度可以例如通过砂子喷射、压制、化学表面外理或激光加工来实现。该由钛片制成的薄膜5保留在其位置上并不必被去掉。X射线图像几乎一点也不会被遮光，所以人们还可以很好地在X照片中识别位于薄膜5下方的并在植入物区域中的变化。
在图2中描述了薄膜9的装入以及与骨骼10的骨折缺陷的关系。如标号11，12所示，该骨骼10或骨折区域例如通过板件或钉子被固置起来。该骨骼件的有缺陷的骨折区域通过非弹性、无应力、连续可变形的薄膜9以皮碗形式包围起来，薄膜9由钛片制成。在连接区域用一个箍带13固定在骨体上且被密封住。该薄膜9使得在骨折区域中软组织与骨骼10隔离开，因此，骨骼再生长可以不受干扰。人们估算骨质增长为10天可生长1mm(毫米)。
图3示出一个用钛片15制造薄膜14的方法。通过至少一个辊轧过程(辊子16，17)，该钛片15被轧至约0.025mm的厚度。该表面区域18，19具有一个被压缩的结构，因此被轧制的材料产生一个弹性作用。在一个连接的化学浴池(酸池)20中被切断的薄膜块21的表面18，19在两侧面被侵蚀。因此，按照目的要求应用流动酸。通过置于化学浴池(酸池)中，人们就可获得希望的薄膜厚度(例如0.015至0.020mm)。同时，该薄膜具有有无应力、非弹性、连续可变形的特性。但是，仅使薄膜尽可能的薄不是目标，而是希望使薄膜在最大强度下具有上述的材料特性。
实施例1：
一个钛片通过辊轧被轧至0.2mm的薄膜厚度，并浸入在一个流动酸池中，在此被停留到获得一个0.1mm的膜厚度。两侧表面为0.05mm的腐蚀量包含了在辊轧过程中会产生不希望的弹性材料性能的部分。通过化学腐蚀从0.2mm减少到0.1mm的厚度所得到的薄膜无弹性、无应力、无反弹并可连续变形。
实施例2：
通过延长在流动酸池中的停留时间，一个薄膜从原始厚度为0.203mm被制成0.08mm的厚度。因此，可同时达到一个粗糙深度，它处于0.003至0.007mm的水平上，这对于软组织的靠着增长是特别适宜的。
实施例3：
一个轧制的薄膜具有0.2mm的厚度并置于一个流动酸池中，并在此用一种压电石英产生一种在超声波范围内的波。在振荡电路的电气部分中共振是可以确定的。这种波可导致在钛薄膜上构成一种结构，它使得在流动酸池中不同的腐蚀量情况下可获得一个均匀的锉纹结构。这样可实现一个在0.08和0.03mm之间的最终膜厚。
实施例4：
通过流动酸处理，一种钛薄膜从0.08mm减少到0.02mm的厚度。这个膜厚特别适合于牙齿区域的应用，因为它对于X射线能保证特别好的穿透度。
图3中，示出了一个位于电流回路31中的振荡石英30，它以可调节的频率将能量输送至薄膜14。该频率如此选择，以使得处于夹住位置32之间的薄膜14受到连续波的作用，从而在流动酸池中获得所希望的表面结构。
薄膜14在实际上被切割成矩形的薄膜块21，在一窄侧边上钻有孔并作为条材悬挂在化学液池中。通过这种悬挂设置，振荡石英的超声波或高频振荡波被耦合接入。因此，在酸池中的薄膜块21可产生上述结构。在钛条材被酸洗刷以后，进行一个干燥过程(例如在100℃的干燥室22中进行)。这种热力的空调作用还可以使最后的剩余应力中和平衡掉。在热处理之前，进行一个表面喷砂或借助激光技术进行一个锉纹处理，然后实施切割，以达到一般商业的尺寸(例如3×4cm)。同时，上述切割如此实施，即在表面上构成一个环绕的毛刺23。这些毛刺23和粗糙的表面24对置，并在应用薄膜14时顶到骨骼上，以起到密封条的作用。另外的处理工艺(如退火)以及接着的冷却处理都可以获得良好的结果，但是不能在所有的处理点上是最理想的。
为了固定一种薄膜的位置，而该薄膜为了覆盖骨骼缺陷位置(例如骨折、牙槽或类似场合)而设置，并起到加速和按要求使骨骼增长的目的。为此，设置了一个由钛制成的钉子8，如图4所示。该钉子8具有一个球面形的头部25，它的凹入的底侧用一个冲制的圆弧结构26过渡到一个杆部27中，杆部27设置成多个倒钩状的截锥锯齿结构28。该头部25具有一个圆形的边缘29，它在钉子8钉入时起到一个用于薄膜5的密封边棱的作用。在头部25下方的凹入中空腔用于容纳在杆部27和头部25之间弯曲的过渡区域，因此，该弯曲的过渡区就可以尽可能少地挤入骨骼中，并另外可容纳由于在薄膜5和环绕杆部27的骨质中打了孔而导致挤出的薄膜及骨料。

Claims (7)

1、一种薄膜，它用于覆盖骨骼缺陷位置和导引骨骼再生，其特征在于，该薄膜(5、9、14)由无弹性、无应力和可连续变形的钛薄膜构成，它具有小于0.025mm的厚度，并将至少一个表面(24)制成粗糙的结构或皱纹式结构。
2、如权利要求1所述的薄膜，其特征在于，该薄膜被裁成多个块件，并形成有切边毛刺(23)，该切边毛刺(23)环绕着周边伸出薄膜表面。
3、如权利要求2所述的薄膜，其特征在于，每个块件的尺寸为3×4cm。
4、一种制造如权利要求1所述薄膜的方法，其特征在于，该薄膜由无弹性、无应力和可连续变形的钛薄膜构成，它具有小于0.025mm的厚度，该方法包括以下步骤：
a.对一钛片进行辊轧，以形成一钛薄膜；
b.用流动酸对该钛薄膜进行化学处理。
5、如权利要求4所述的方法，其特征在于，进一步包括对所述钛薄膜施加超声波并形成稳定波的步骤。
6、如权利要求4所述的方法，其特征在于，进一步包括对所述钛薄膜的至少一个表面进行粗糙化处理或形成皱纹式结构的步骤。
7、如权利要求4所述的方法，其特征在于，进一步包括将所述钛薄膜裁成尺寸为3×4cm的多个块件的步骤。
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EP0809979A1 (de) 1997-12-03
US5976140A (en) 1999-11-02
AT403002B (de) 1997-10-27
JPH1052441A (ja) 1998-02-24
ES2180916T3 (es) 2003-02-16
EP0809979B1 (de) 2002-07-31
EP0809979B2 (de) 2008-04-09
ATA93396A (de) 1997-03-15
AU2348497A (en) 1997-12-04
BR9703411A (pt) 1998-09-15
CN1181228A (zh) 1998-05-13
DE59707835D1 (de) 2002-09-05
ID17709A (id) 1998-01-22

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