CN1269845A - 可植入的形状记忆合金医疗器件 - Google Patents

可植入的形状记忆合金医疗器件 Download PDF

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CN1269845A
CN1269845A CN98807247A CN98807247A CN1269845A CN 1269845 A CN1269845 A CN 1269845A CN 98807247 A CN98807247 A CN 98807247A CN 98807247 A CN98807247 A CN 98807247A CN 1269845 A CN1269845 A CN 1269845A
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J·弗洛门伯里特
N·巴迪吉纳
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Abstract

提供一种包含形状记忆合金(SMA)部分的医疗器件。该SMA部分可从其在奥氏体状态时具有的未变形的第一形态变形为第二形态,从而所述变形使其转变为应变诱发马氏体状态或部分马氏体状态,同时其As从其初始温度As o升高到As′;并且当一旦处于所述第二形态的所述SMA部分被加热到高于As′的温度时,它转变为至少部分奥氏体状态,该转变使得从变形的第二形态变为未变形的第一形态并且伴随As从As′降低为As o,从而在体温下所述SMA部分稳定处于所述至少部分奥氏体状态。

Description

可植入的形状记忆合金医疗器件
发明领域
本发明涉及可植入的医疗器件，具体涉及可以从应变诱发的马氏体状态热膨胀为稳定的奥氏体状态的可植入形状记忆尼太诺尔(nitinol)合金器件。
发明背景
可植入的医疗器件，例如斯滕特固定器、心脏瓣膜、骨板(boneplate)、宫内避孕器等必须满足各种要求以便使用并具有对其应用的安全性。例如，它们对活体组织必须是化学和生物学惰性的，并且可在其位置长期存留。此外，上述类型的器件必须能够从便于插入体内导管或体腔的收缩状态膨胀到使用时的膨胀直径。这种膨胀或者通过强制膨胀完成，如在某些斯滕特固定器的情形下是利用具有端部气囊的导管的作用而完成或者通过如形状记忆效应的自膨胀完成。
一种广泛使用的此类合金是称为“尼太诺尔”的镍-钛合金。在某些条件下，尼太诺尔具有很大弹性，从而能够发生很大变形，而后又能返回到其初始形状。此外，尼太诺尔具有形状记忆性质，使其能够“记忆”在特定热处理时施加的特殊形状，并在特定条件下再现该施加的形状。
尼太诺尔的形状记忆效应来自金属相变。某些尼太诺尔具有特征转变温度或转变温度范围，高于这些温度其主要的金属相称为“奥氏体”，低于这些温度其主要的金属相称为“马氏体”。从奥氏体(或奥氏体状态)向马氏体(或马氏体状态)的转变称为“马氏体转变”；从奥氏体向马氏体的逆转变称为“奥氏体转变”。该转变发生在一定的温度范围，并通常参照分别为马氏体转变的起始温度和结束温度的Ms和Mf以及分别为奥氏体转变的起始温度和结束温度的As和Af来描述。这两相之间的转变是可逆的，从而该合金可被处理成在这两相具有不同的形状或形态，并且在从一种相转变为另一种相时可从一种形状可逆地变化到另一种形状。对于尼太诺尔医疗器件，优选在体内展开时保持为奥氏体状态，因为尼太诺尔奥氏体比尼太诺尔马氏体强度高并且较不易变形，从而更能抵抗外力。
由尼太诺尔制成的可植入医疗器件在本领域是已知的。例如参见美国专利3786806、4485816和5037427。在美国专利5562641中，采用双程形状记忆效应，使得奥氏体转变温度高于体温，而马氏体转变温度低于体温，由此，该器件在体温下保持其最后的处理状态(例如奥氏体或马氏体)。美国专利5624508公开了一种具有确定转变温度的形状记忆合金(SMA)器件的制备方法。许多这种器件中，As显著高于体温，因此为将此器件转变为奥氏体状态，必须以不仅难以施加而且可能造成对周围组织的损伤的程度提供热。对于As仅仅稍高于体温的器件，例如由于发生应力诱发马氏体转变，奥氏体将变得不稳定，使器件抵抗外应力的能力降低。
许多传统的尼太诺尔医疗器件的As和Af之间的温度范围一般很大，因此很难精确地和可再现地建立加热时奥氏体转变的程度。
在医疗器件中可同样利用应力诱发马氏体原理，而非温度诱发马氏体，例如美国专利4665906。在这些器件中，使奥氏体变形，形成应力诱发马氏体，并采用约束元件保持其变形的形态和马氏体状态。以其变形形态将所述器件置入体内，去掉约束元件使其恢复奥氏体状态和形态，而没有任何温度变化。这种器件必须使用约束元件，并且一旦从该医疗器件上去掉约束元件，它几乎立即展开。如果没有恰在释放约束元件之前将器件精确放置，那么可能就不得不将其取出，并造成周围组织的损伤。
发明简述
本发明涉及例如斯滕特固定器、心脏瓣膜、骨板、钳、牙齿植入物、导管、宫内避孕器等的可植入医疗器件。
下文中，术语“形状记忆器件”意指全部或其至少一个功能部分由形状记忆合金(SMA)制成的器件。术语“功能部分”意指对医疗器件的功能起主要作用的器件部分。形状记忆器件利用SMA的形状记忆性质行使其功能：整个器件或至少其功能部分会因其奥氏体向马氏体(如果需要也可按相反方向转变)的金属相转变而发生形态变化。术语“形态”应理解为意指SMA的形状、直径、弹性、拉伸性质或其它任何影响SMA在体内功能的性质。
本发明提供一种医疗器件，该器件具有至少一个包括双程形状记忆类型的SMA的功能部分，即具有奥氏体和马氏体所呈现的两个不同的“记忆”形态。此外，本发明的器件具有受应变影响的马氏体向奥氏体转变的温度(As和Af)，即变形后该温度会提高(应变诱发的形态变化)。这样该变形会形成应变诱发的马氏体，使As(未变形态时低于体温)提高到As′。一旦在体内转变为奥氏体，As恢复到其初始温度值(As°)，因此该器件稳定在其奥氏体状态。
本发明的第一方案提供一种医疗器件，其中含有在其奥氏体状态和其马氏体状态分别具有不同形态的形状记忆合金(SMA)部分，该SMA可通过发生在奥氏体转变起始温度As和奥氏体转变结束温度Af之间温度范围内的奥氏体转变而从马氏体转变为奥氏体，并可通过发生在马氏体转变起始温度Ms和马氏体转变结束温度Mf之间低于体温的温度范围内的马氏体转变而从奥氏体转变为马氏体，在未变形状态As低于体温，所述器件的特征在于：
该SMA部分可从其在奥氏体状态时具有的未变形的第一形态变形为变形后的第二形态，从而该变形使其转变为应变诱发马氏体状态或部分马氏体状态，同时其As从其初始温度As°升高到As′；并且
当一旦处于所述第二形态的SMA部分被加热到高于As′的温度时，它转变为至少部分奥氏体状态，该转变使得从变形的第二形态变化为未变形的第一形态并且伴随As从As′降低至As°，从而在体温下在所述至少部分奥氏体状态，SMA部分是稳定的。
本发明的第二方案提供一种在人体内展开医疗器件的方法，该医疗器件包括在其奥氏体状态和其马氏体状态分别具有不同形态的形状记忆合金(SMA)部分并具有有关的Ms、Mf、As和Af温度，这些温度分别是所述SMA的马氏体转变起始温度和结束温度和该SMA的奥氏体转变起始温度和结束温度，在所述器件处于未变形状态时，As具有低于体温的值As°，Ms低于As，所述方法包括下列步骤：
通过施加应变使所述医疗器件从其在奥氏体状态下的未变形第一形态变为变形后的第二形态而使该医疗器件变形，所述变形使As从As°升高到As′，该变形后SMA部分处于应变诱发的马氏体状态或部分马氏体状态；
将该医疗器件定位于体内的目标位置，在所述定位过程中，该SMA部分保持在所述应变诱发马氏体状态或部分马氏体状态；然后
通过将其加热到高于As′的温度，将该SMA部分从所述马氏体状态或部分马氏体状态转变为至少部分奥氏体状态，该转变使得SMA部分的形态改变，即从变形的第二形态变为未变形的第一形态，形态的变化使得As从As′下降为As°，从而在体内展开时，所述医疗器件在至少部分奥氏体状态是稳定的。
熟练技术人员将会理解As从As°提高到As′伴随着Af从Af°提高到Af′。
在将医疗器件定位在体内目标位置后，如上所述，将该SMA部分加热到高于As′的温度，使该SMA部分从应变诱发马氏体或部分马氏体状态转变到至少部分奥氏体状态。如果加热至As′和Af′之间的温度，该SMA将只发生部分奥氏体转变并此后保持部分奥氏体状态。如果将该SMA加热至高于Af′的温度，其将发生完全奥氏体转变并此后保持完全奥氏体状态。
根据本发明的一个实施方案，As′高于体温。一般在这种SMA中，变形后它转变为，并在该器件展开过程中保持完全马氏体状态。无需借助于例如美国专利4665906所要求的约束元件即可展开这种器件。
根据本发明的另一个实施方案，As′低于体温，Af′但高于体温。在应变变形后，SMA部分可处于完全或部分马氏体状态。
根据本发明的一个实施方案，医疗器件可具有初始形状，从而在变形时该SMA不同的部分以不同的应变变形。结果，不同部分的As′会因此而不同。举例来说，第一SMA部分可具有大小为t1的As′，第二SMA部分可具有为大于t1的t2的As′。这样，如果将器件加热到高于t1但低于t2的温度，所述第一部分将转变为奥氏体或部分奥氏体状态，而所述第二部分仍保持马氏体状态。这种器件的实例是具有分别处于奥氏体和马氏体状态的交替部分的斯滕特固定器；一个具有处于奥氏体状态的两个整体部分和处于马氏体状态的中间连接部分的斯滕特固定器等。这种斯滕特固定器在展开时将同时具有支撑动脉管壁的刚性部分和中间的柔韧部分，因此适于在弯曲的动脉区域展开。另一实例是具有钩状部分的斯滕特固定器，具体如实施例3所示。如果仍处于马氏体状态的该SMA或其至少一部分加热至高于t2(即其As′温度)的温度，则SMA整体转变为奥氏体状态。对于具有如实施例3的钩状元件的斯滕特固定器，这可使该斯滕特固定器易于移出或再展开。
应理解的是，可利用SMA的双程形状记忆性质，通过将其冷却到低于Ms的温度，使SMA转变为可便于移出和再展开该医疗器件的马氏体或部分马氏体状态。
现参考附图，在发明详述和实施例中详细描述本发明。
附图简述
图1示出的是本发明医疗器件的奥氏体转变温度和应变之间的关系。
图2示出的是作为本发明书本式实施方案的血管内斯滕特固定器。
图3示出的是牙齿植入物两种状态下的纵剖面图：奥氏体状态(图3A)和展开在颚骨中的应变诱发马氏体状态(图3B)。
发明详述
本发明的器件可由任何适合的形状记忆材料制成，优选为尼太诺尔。本发明医疗器件中的SMA在体内展开时处于至少部分奥氏体状态。为制造本发明的医疗器件，将SMA成形为其期望的形态并在高温退火。关于SMA的制造方式，参见美国专利5624508，其内容引入本文作为参考。然后将SMA冷却到低于As但高于Ms的温度，以保持奥氏体状态。在该未变形状态，SMA的As，即As°，低于正常体温(37℃)。然后变形该医疗器件至一定程度，以使部分或全部奥氏体转变为应变诱发马氏体。SMA一般无需借助任何约束元件等即可保持在其变形的马氏体或部分马氏体状态。
从图1可见，对SMA的变形造成As和Af从As°和Af°提高到As′和Af′，该提高程度取决于应变程度。此外，从图1可见，随着应变量的增大，As′和Af′之间的差异减小。通常SMA器件变形直到As高于正常体温(37℃)并且As和Af之间的范围最小。现在无需借助约束元件即可将该器件插入体内，而不会自发转变为奥氏体。
有时也将SMA变形到使As提高到低于体温的As′温度，但同时Af′高于体温(Af°可低于或高于体温)。此时，SMA仅处于部分马氏体状态，并且其插入可能需要或不需要约束元件(取决于马氏体比例)。
将器件定位于目标位置，然后采用常规方式(例如通过暴露于流经展开导管的热盐溶液，通过微波辐射加热等等)加热至高于As′、优选高于Af′的温度。因此，器件中部分或全部马氏体转变为奥氏体，从而使器件形态发生从变形的形态到未变形的奥氏体形态的变化。该形态变化造成应变下降，这又造成As从As′降至低于体温的As°。因此，该医疗器件在体内展开时稳定在至少部分奥氏体状态。
有可能按照本发明使同一医疗器件不同区域经受不同的变形量。因此，这些不同区域会具有不同的转变温度，从而低应变区域可在比高变形区域低的温度转变为奥氏体。通过使这种医疗器件处于“活化”温度，该活化温度高于低应变区域的As′温度(t1)但低于高应变区域的As″温度(t2)，可制备出在所需位置具有奥氏体区域和马氏体区域的医疗器件。该马氏体区域的特征在于具有良好的柔韧性和弹性，而所述奥氏体区域的特征在于较高的强度和抗变形能力。
下列实施例中进一步描述了本发明，但本发明不限于此。
实施例1线圈式斯滕特固定器(Coil stent)
参照图1，制备了具有本发明特征的血管内尼太诺尔斯滕特固定器，发现该固定器具有作为应变函数的如下转变温度：
变形量 As(℃) Af(℃)
O-ε1 As＝As°＝28 Af＝Af°＝33
ε2 As＝As′＝37 Af＝Af′＝41
ε3 As＝As′＝43 Af＝Af′＝43.5
将该斯滕特固定器加热到35℃，并变形为所需的最终形态。退火处理如此成形的斯滕特固定器，然后冷却至低于合金Af°(28℃)但高于Ms温度的温度，由此保持奥氏体状态。然后以压缩应力对该斯滕特固定器进行变形至等于图1中ε3的应变。该变形导致应变诱发马氏体的形成，并使As和Af分别变化到43℃和43.5℃。该压缩形态促进斯滕特固定器在其被展开的血管中易于引入和移动。使用该斯滕特固定器对猪进行了试验。
一旦通过导管定位于体内目标位置，斯滕特固定器就通过流经展开导管的热盐溶液被加热到44℃。这种加热使得完全转变为奥氏体，并使斯滕特固定器的形态相应变化为其期望的最终形态。这种形态变化导致应变下降至O-ε1范围，这样As和Af均低于体温。因此，该斯滕特固定器在体内展开时处于稳定的完全奥氏体状态。
实施例2螺旋带斯滕特固定器
由尼太诺尔线材在400℃轧制得到带材(厚度0.15mm，宽度2.0mm)。然后，将该带材安装在芯轴(直径5.0mm)上形成环间具有间隙的螺旋形状。为了形成外径为5.3mm的螺旋斯滕特固定器期望的最终形态，在500℃处理该带1.5小时，然后在700℃处理0.5小时，然后在550℃处理0.5小时，最后在480℃处理1.5小时。这种退火之后，斯滕特固定器的As和Af分别确定为28℃和33℃。然后将该斯滕特固定器冷却至室温(约25℃)并在直径逐渐减小到1.0mm的不同芯轴上变形。这种变形导致形成了应变诱发马氏体。在每个芯轴上变形之后斯滕特固定器的As和Af温度如下表所示：
斯滕特固定器直径(mm)   ε(％)    As(℃)    Af(℃)
    4.0     0.8     28     33
    3.0     2.0     28     33
    2.5     3.0     33     38
    2.0     4.5     38     40
    1.5     7.0     42     43
    1.0     12     44     44.5
就上表所列转变温度而言，该斯滕特固定器在变形至直径不超过2.0mm时无需外覆鞘层即可通过导管插入体内，因为As温度高于体温(37℃)，因此斯滕特固定器在插入过程中并不转变为奥氏体。
该斯滕特固定器在猪和人体上进行了试验，并展开在试验对象体内的气管、食道、尿道和胆管中。该斯滕特固定器变形至1.5mm直径，并定位在血管内的目标位置。此后，将斯滕特固定器加热至43℃，以转变为奥氏体并使斯滕特固定器向期望的最终形态变化。斯滕特固定器在体内展开时的最终直径约4mm，从而整个奥氏体转变温度范围低于体温。因此，该斯滕特固定器在体内展开时稳定处于其奥氏体状态。
实施例3带有移出钩的螺旋带斯滕特固定器
在其奥氏体状态成形实施例2所述的斯滕特固定器，使其具有从该斯滕特固定器外周向其中心延伸的钩状元件(图2)。当随后在不同的芯轴上缠绕以使斯滕特固定器直径为1.7mm时，该斯滕特固定器大部的特征是具有5.0％的应变，但是为了形成钩状元件在奥氏体状态经历了高度变形的钩和斯滕特固定器的“肘部”区域除外。在奥氏体状态形成肘部区域的位置处的变形接近7％。除了钩和肘部区域外，整个斯滕特固定器的As′和Af′温度分别为41℃和43℃。在人体和猪上进行试验并安置于实施例1所述器官内的斯滕特固定器，放置在目标位置并加热到41℃，从而使斯滕特固定器整体除原来形成的肘部区域保持马氏体之外均转变为奥氏体。斯滕特固定器在可使用寿命内保持该状态。为了在停止使用时方便地移出斯滕特固定器，将其加热到45℃以便在原先形成的肘部区域引发奥氏体转变。因此，再次形成钩，由镊子夹住移出体外。
实施例4牙齿植入物
如图3A所示的牙齿植入物30由具有用于固定于颚骨内的腿状伸出元件的锚定部分34组成，它由尼太诺尔(50.5％原子Ni)经500℃拉拔并在650℃处理0.5小时、500℃处理2小时和450℃处理1.5小时而制成。伸出元件32在20℃由“张开”形态(由图3A的虚线表示)拉直为沿箭头34方向的应变形态(图3A阴影表示)，其应变为5％，因而形成应变引发马氏体并使As和Af分别升高到39℃和42℃。然后将该植入物插入钻在颚骨的牙根管36(图3B)中。使该植入物接触45℃的盐溶液，从而引发向奥氏体的转变，并使植入物的形态变为图3B中所示形态，从而很好地锚定于颚骨内。此外，该植入物对周围的骨施加恒定的应力并保持不超过2％的应变，此时As＝30℃，Af＝35℃。
实施例5骨折愈合器件
制造压缩骨折愈合器件，该器件包括其内部具有尼太诺尔线材(50.8％原子Ni)的两个螺丝状节段。将线材冷拔至直径0.5mm，然后在500℃退火3小时。拉延该线材至应变7％，形成应变诱发马氏体并使As和Af分别升高至39℃和41℃。将该器件插入断骨，此时使其接触1-2毫升45℃的盐溶液以引发向奥氏体的转变。该转变使应变下降到约3％，此时As＝30℃，Af＝34℃。以这种方式使用该器件可在断骨表面产生恒定的压力。
以上是本发明某些实施方案的详细讨论。它们不应被理解为限制由权利要求书所确定的本发明的范围。

Claims (19)

1.一种医疗器件，其中包含在其奥氏体状态和其马氏体状态分别具有不同形态的形状记忆合金(SMA)部分，该SMA可通过发生在奥氏体转变起始温度As和奥氏体转变结束温度Af之间温度范围内的奥氏体转变而从马氏体转变为奥氏体，并可通过发生在马氏体转变起始温度Ms和马氏体转变结束温度Mf之间低于体温的温度范围内的马氏体转变而从奥氏体转变为马氏体，在未变形状态As低于体温，所述器件的特征在于：
该SMA部分可从其在奥氏体状态时具有的未变形的第一形态变形为变形后的第二形态，从而该变形使其转变为应变诱发马氏体状态或部分马氏体状态，同时其As从其初始温度As°升高到As′；并且当一旦处于所述第二形态的所述SMA部分被加热到高于As′的温度时，它转变为至少部分奥氏体状态，该转变使得从变形的第二形态变为未变形的第一形态并且伴随As从As′降低为As°，从而所述SMA部分在体温下稳定处于所述至少部分奥氏体状态。
2.根据权利要求1的医疗器件，其中，所述形状记忆合金是尼太诺尔。
3.根据权利要求1的医疗器件，其中，所述SMA的至少一部分与它的其余部分相比可经变形具有更高的应变，从而所述至少一部分具有高于SMA其余部分的As′温度t1的As′温度t2。
4.根据权利要求3的医疗器件，通过将SMA加热到高于t1但低于t2的温度而在体内展开，其中所述至少一部分在展开时保持马氏体状态，而该SMA其余部分转变为奥氏体。
5.根据权利要求1-4中任一项的医疗器件，其中，As′高于体温。
6.根据权利要求1-4中任一项的医疗器件，其中，As′低于于体温并且Af′高于体温。
7.一种在人体内展开医疗器件的方法，该医疗器件包含在其奥氏体状态和其马氏体状态分别具有不同形态的形状记忆合金(SMA)部分并具有有关的Ms、Mf、As和Af温度，这些温度分别是所述SMA的马氏体转变起始温度和结束温度和该SMA的奥氏体转变起始温度和结束温度，在所述器件处于未变形状态时，As具有低于体温的值As°，所述方法包括下列步骤：
通过使所述医疗器件从其在奥氏体状态下未变形的第一形态转变为变形后的第二形态而使该器件变形，所述变形使As从As°升高到As′，所述变形后该SMA处于应变诱发马氏体状态或部分马氏体状态；
将该医疗器件安置于体内的目标位置，在安置过程中，该SMA部分保持应变诱发马氏体状态或部分马氏体状态；然后
通过将其加热到高于As′的温度，将该SMA部分从所述马氏体状态或部分马氏体状态转变为至少部分奥氏体状态，该转变使得该SMA部分从变形的第二形态变为未变形的第一形态，形态的变化使得As从As′下降为As°，从而在体内展开时，所述医疗器件稳定处于至少部分奥氏体状态。
8.一种在人体内展开医疗器件的方法，该医疗器件包含在其奥氏体状态和其马氏体状态分别具有不同形态的形状记忆合金(SMA)部分并具有有关的Ms、Mf、As和Af温度，这些温度分别是所述SMA的马氏体转变起始温度和结束温度和该SMA的奥氏体转变起始温度和结束温度，在所述器件处于未变形状态时，As具有低于体温的值As°，并且Ms低于As，所述方法包括下列步骤：
将该SMA加热到高于As的温度，从而使所述SMA处于至少部分奥氏体状态；
将该医疗器件冷却到As和Ms之间的温度；
变形所述医疗器件使其从其在奥氏体状态下未变形的第一形态变形为变形后的第二形态，所述变形使As从As°升高到As′，所述变形后该SMA部分处于马氏体状态或部分马氏体状态；
将该医疗器件安置于体内的目标位置，在安置过程中，该SMA部分保持马氏体状态或部分马氏体状态；然后
通过将其加热到高于As′的温度，将该SMA部分从所述马氏体状态或部分马氏体状态转变为至少部分奥氏体状态，该转变使得SMA部分的形态从变形的第二形态变为未变形的第一形态，形态的变化使得As从As′下降为As°，从而在体内展开时，所述医疗器件稳定处于至少部分奥氏体状态。
9.根据权利要求8的方法，其中，所述形状记忆合金是尼太诺尔。
10.根据权利要求8或9的方法，其中，在变形期间所述SMA的至少一部分与它的其余部分相比经所述变形具有更高的应变，从而所述至少一部分具有高于SMA其余部分的As′温度t1的As′温度t2。
11.根据权利要求10的方法，其中将SMA加热到高于t1但低于t2的温度，从而使所述至少一部分保持马氏体状态，而该SMA其余部分转变为奥氏体。
12.根据权利要求11的方法，还包括在所述转变步骤后将SMA加热到高于t2的温度，由此使所述至少一部分从马氏体状态转变为奥氏体状态。
13.根据权利要求11的方法，还包括通过夹住在加热至大约t2温度的过程中发生了转变的具有较高应变的所述至少一部分而将医疗器件从体内取出。
14.根据权利要求1-6中任一项的医疗器件，它是医用斯滕特固定器。
15.根据权利要求1-6中任一项的医疗器件，它是牙齿植入物。
16.根据权利要求1-6中任一项的医疗器件，它是骨折愈合器件。
17.根据权利要求1-6中任一项的医疗器件，它是心脏植入物。
18.根据权利要求1-6中任一项的医疗器件，它是骨板。
19.根据权利要求1-6中任一项的医疗器件，它是宫内避孕器。
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CA2296317C (en) 2009-01-20
CA2296317A1 (en) 1999-01-28
CN1091169C (zh) 2002-09-18
EP1017868B1 (en) 2003-09-03
DE69817846T2 (de) 2004-07-08
EP1017868A1 (en) 2000-07-12
IL121316A (en) 2001-07-24
KR20010021843A (ko) 2001-03-15
DE69817846D1 (de) 2003-10-09
IL121316A0 (en) 1998-01-04
ATE248933T1 (de) 2003-09-15
HK1031900A1 (en) 2001-06-29
WO1999004053A1 (en) 1999-01-28
RU2196188C2 (ru) 2003-01-10
ES2206914T3 (es) 2004-05-16
TW519550B (en) 2003-02-01
JP2001510084A (ja) 2001-07-31
AU7076898A (en) 1999-02-10
DK1017868T3 (da) 2004-08-16
US5876434A (en) 1999-03-02

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