CN1373816A - 存储形状记忆合金的方法 - Google Patents

存储形状记忆合金的方法 Download PDF

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CN1373816A
CN1373816A CN00812759A CN00812759A CN1373816A CN 1373816 A CN1373816 A CN 1373816A CN 00812759 A CN00812759 A CN 00812759A CN 00812759 A CN00812759 A CN 00812759A CN 1373816 A CN1373816 A CN 1373816A
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state
processing method
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CN1183271C (zh
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R·叙尔
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MAT INOV SARL
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MAT INOV SARL
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    • A61B17/72—Intramedullary pins, nails or other devices
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Abstract

使得由一种形状记忆合金制成的产品记住两种几何状态的工艺方法及其应用使得由一种形状记忆合金制成的产品记住两种几何状态的工艺方法,以及这种工艺方法在医学、牙医学、兽医学或类似领域中的产品上的应用。本发明涉及一种工艺方法,该工艺方法用来使得由一种形状记忆合金制成的产品记住两种几何状态,所述工艺方法的特征在于,该方法包括:a)通过对所述的产品进行作用而使所述合金记住第一几何状态,使之在第一温度下达到第一状态并使之在第一温度下保持所述第一状态,然后b)通过对所述的产品进行作用而使所述合金记住第二几何状态,使之在第二温度下达到第二状态并使之在第二温度下保持所述第二状态。本发明还涉及这种工艺方法在医学、牙医学、兽医学或类似领域中的应用。

Description

存储形状记忆合金的方法
本发明涉及使得由一种形状记忆合金制成的产品记住两种几何状态的工艺方法。本发明还涉及到如何将这种工艺方法应用到产品上，该产品将被固定在另一个元件上，且随后将从该产品上拆卸下来。本发明还涉及将这种工艺方法应用到医学、牙医学以及兽医学等领域中的产品上。
形状记忆合金，也称之为SMA，是一种现有技术。由于有这种记忆效应，一种在第一温度进行变形处理后的材料将会在其温度回复到第二温度时恢复到其初始形状。这种效应是由于在奥氏体固相和同样为固相的马氏体相之间存在的热弹性转变所导致的。
有多种不同的现有合金都可表现出这种效应。
将这些合金的这种效应应用到医学领域也是众所周知的，特别是生产用于骨头元件的连接部件或联结夹。关于这种记忆材料的应用的描述可参考FR-A-2700464。
需要指出的是，在此以说明性的方式通过本发明在医学领域部分的应用对本发明进行说明。
当前，形状记忆合金在医学领域部分的应用还限于将产品固定到元件上，还不能够进行将所述的产品从该元件上拆卸下来的下一阶段。例如，在人体移植方面，目前采用记忆合金有利于插入但是毫不利于记忆合金的拆除，而拆除目前也不太受到人们的关注。
本发明的目的是为了提出一种处理具有记忆效应的产品的工艺方法，通过这种效应，首先能够将这种相关的产品贴到一个元件上，其次，能够将所述产品从所述元件上拆下来。因此，本发明的目的是为了提出一种工艺方法，该工艺方法不象现有技术所述的那样只记忆一种几何状态，而是使得由一种形状记忆合金制得的产品能记忆两种几何状态。
为此，本发明的工艺方法包括：
a)通过对所述的产品进行作用而使所述合金具有第一几何状态，使之在第一温度下达到第一状态并使之在第一温度下保持第一状态，然后
b)通过对所述的产品进行作用而使所述合金具有第二几何状态，使之在第二温度下达到第二状态并使之在第二温度下保持第二状态。
如果所研究的产品是将要置于一种生物体中的植入物，就可以通过使该植入物处于两种几何状态中的其中一种状态而将该植入物植入，该状态可以通过提供必要的热量而使得该植入物达到与该状态相应的温度而实现。可以通过使该植入物处于另一种状态而将该植入物拆卸下来，该状态可以通过提供必要的热量而使得该植入物获得与该另一状态相应的温度而实现。
需要指出的是，植入时的几何状态与所述植入物作用在一元件上的状态相应，例如另一个植入物，身体的另一个成分或部位，从而将其自身固定在该元件上。至于拆卸时的几何状态，其要与所述植入物恢复到其植入之前所处的初始状态或所处的类似状态相应。
因此，由于植入物被做成一种受过培养的合金而具有两种显著的几何状态，这使得植入物能够在一种状态下植入并使其在另一种状态下能被拆下。
所采用的合金例如是一种镍或钛合金，或者是一种由所述合金进行加强后的复合材料。
例如，所考虑的两个温度中的最高温度在+37℃到+55℃范围之间，而最低的温度在+30℃和-30℃之间。
如果本发明用于医学领域，最高温度可以通过透热刀来实现，而最低温度可以通过生理血浆、cryode等来实现。
根据本发明的另一个特征，所述的方法包括在使所述合金记住第一几何状态之后且在使所述合金记住第二几何状态之前对所述产品进行精加工。该精加工步骤可包括对该产品进行抛光，例如通过砂子打磨进行抛光。
为了防止所述记忆合金中所含的镍与人体接触，精加工步骤可以包括施加一层薄的保护膜，该保护膜的厚度在例如1-5微米的范围内。
这层膜可以由下面其中一种材料制成：
碳化镍
氧化铝
二硫化钼
碳氮化钛(腈化钛)，
镍、钛以及铝的三元材料
氮化铬
非晶态的黑金刚石
碳化钛
氮化钛等
这些保护膜例如是一种在低温下通过对所述产品进行氮化所获得的薄层。它可以通过离子轰击或通过气相沉积方式进行。
需要指出的是，在低温下进行氮化处理的作用除了对人体起保护作用外，还能够增大合金在冷热状态下的记忆力。
而且，因为这种氮化处理能更快地获得一种非常好的表面状况，因此这种氮化处理缩短并因此简化了对未被精加工的该产品进行抛光的步骤。这种氮化处理也制出了受到摩擦或负载作用的部分。
本发明可以用于任何领域，只要该领域属于需要采用一种具有两种几何状态的产品。本发明特别涉及在产品上的应用，该产品通过紧固的方式固定到一元件上并随后从该元件上拆下来。在公开文本的后面的部分，将会为解释性的目的以在医学领域的应用为例进行说明，例如，用于人体移植物中。
下面将参考附图对本发明的工艺方法的应用实例进行描述，其中
图1是以一个联结夹作为实施例对本发明进行图释的视图，
图2a-2d是以一个销钉为实施例对本发明的工艺方法进行图释的视图，
图3所示的是一个窝槽的透视图，本发明将会被用于该窝槽上，
图4a-4c所示的是一个以锚钉为实施例来对本发明的工艺方法进行图释的视图，以及
图5所示的是一个股骨茎装置的视图，该装置采用了本发明的形成记忆的工艺方法。
首先，参考图1对在人体植入物方面的应用进行研究，这些植入物是用于外科整形或伤害修复的联结夹，且这些联结夹或者用于将韧带保持在一起或者将骨头连接(以骺联结夹为例)。这些植入物也可以是用于脊柱治疗时的联结夹。这些植入物也可是在医学或外科手术时所用的缝合钉。
根据本发明获得一种联结夹的工艺方法如下。该联结夹通过一个例如由一种镍和钛的合金制成的金属线10获得，该合金中镍和钛的化学计量比最好接近于1，接着以机械加工方式使其成型，从而使其成为一种“n”形11，该“n”形11具有两个通过中心11c连接在一起的支腿11a和11b。这就是联结夹的所谓的初始形状。
接着，该成型联结夹的支腿11a和11b受到力的作用，使其彼此拉近。然后获得第一几何状态12。该操作是在温度T1下进行的，温度T1位于37℃到55℃范围之间，例如40℃。该操作在例如一种台钳中或采用一种具有与所需形状互补形状的模具20进行。从而，可以认为该联结夹已经记住了第一种记忆状态。
接着在联结夹的状态12下对联结夹进行精加工步骤。该步骤可以通过例如喷砂进行抛光，或通过例如气相沉积或氮化以低温沉积方式形成涂层。该步骤在图1中用标记N表示。
在进行该精加工步骤之后，联结夹的支腿受到力的作用而使之具有不同于第一几何状态12的第二几何状态。根据将要使用的场合，该第二几何状态可以为状态13，联结夹在该状态13中恢复到其初始状态11，在初始状态11时其支腿11a和11b是平行的；或者为状态13′，联结夹在该状态13′中彼此分离开。该操作在温度T2下进行，该温度T2在-30℃到+30℃之间，例如为5℃.。该操作例如可以采用一个皮带轮装置或采用一个用于第二几何状态的具有与所需形状互补的适当形状的模具21或21′来进行。
实际上，就联结夹而言，状态13优选为13′，以便其能够被拆下来。
这种类型的联结夹的使用方法如下。在进行植入时，联结夹就位并对联结夹施加热量，使得联结夹达到温度T1。由于该温度为高温，因此可以采用一种例如透热刀。接着，它将获得其几何状态12，这两个支腿在该状态下会彼此拉近。从而该联结夹会保持这种状态。在这种状态下，联结夹被固定到其支承件上，例如一块骨头上，并且在不采取下一步行为时联结夹不会脱落。
为了将其拆下来，需要对所研究的联结夹加热，使其达到温度T2的范围内，从而使得联结夹获得几何状态13，其支腿在该状态下再次处于平行状态。随后通过平行于其支腿回抽就能够拆下该联结夹。由于该温度较低，因此采用生理血浆(导热)就可以了。
在他们处于记忆状态下时确定与几何状态12、13、13′相应的一些形状，并选择这种形状使得它们与所考虑的联结夹相适应。
需要指出的是，在上述给定的联结夹的实施例中，并根据本发明的变化，温度T1可以为最低，例如在-30℃到+30℃之间，而温度T2为最高，例如在+37℃到55℃之间
针对图2a-2d对本发明的工艺方法的另一种应用进行了描述，且该应用涉及主要用于连接骨头的销钉30。销钉30基本由一个管构成，该管的侧面开有一条纵向狭缝31。该销钉的下端32的稍微作得象套针尖端，以便于插进为此而钻的空腔。
图2b所示的是销钉30的圆弧断面，其处于培养前的初始状态30A。在图2c中，销钉30处于受到温度T1培养后的第一几何专状态30B。表示销钉30的断面的圆弧相对于初始状态30A开口要大些。在图2d中，销钉30处于受到温度T2培养后的第二几何状态30C。表示销钉30的断面的圆弧相对于前述几何形状30B开口稍微收拢一些，但是相对于初始状态30A开口又开得大一些。
在此通过举例的方式所给出的断面形式是一种简单圆弧。可以理解的是，断面可以是更复杂的形状。
在前面描述的最后一个步骤之后还可以跟随一个步骤，在该步骤中使销钉30返回其初始状态。该步骤在室温下通过机械方式进行。
这种类型的销钉30的使用方法如下。外科医生采用例如一种根管扩孔钻在骨头中钻一个孔，使得该孔能够容纳处于初始状态的销钉30。孔的直径要稍微大于销钉30的外径，使得销钉可以插进去。
在插进销钉后，销钉30受热，使得销钉达到温度T1。随后销钉30使其自身处于第一几何状态30B，销钉在该状态下使其自身楔靠在骨头中所形成的孔的侧壁上。然后，在治疗的过程中销钉保持形状不变，并且在没有采取进一步的行为之前不会脱落。
到了要将销钉拆卸下来的那天，销钉受热，使其温度达到T2。随后销钉收缩并使其自身处于第二几何状态30C。
需要指出的是，销钉在第二几何状态30C下封闭的程度要比在第一几何状态30B要大，但是要比在初始状态30A下小，这意味着销钉不会损坏海绵组织，该海绵组织在治疗期间会长进到销钉中。
除了采用本发明的工艺方法能够使得被植入的销钉30拆卸下来外，采用具有双记忆功能的材料所产生的优点在于，相对于该领域的现有状态而言它有利于销钉的插入。在现有技术状态下，销钉需要借助于螺钉来固定，该螺钉的插入需要采用荧光监视屏，而该监视屏通常是有害甚至是危险辐射的源头。而且插入和拆除操作进行起来比较容易。
采用相同的方式，也就是说采用具有纵向狭缝的管形件，还能够制造通常用来固定板材、韧带等的铆钉。它们的使用方式基本上与对上述图2a中的销钉30所描述的方式相同。
同样采用相同的方式，还可以制造一种股骨茎部件。
需要指出的是，销钉或铆钉中只有一部分带有一个侧缝或者甚至几个侧缝。
图3所示的是窝槽40，通常首先用来容纳一种假体例如一种股骨部分的球头，其次用于将其自身固定到相应的关节腔中。
窝槽40由一种基本上成半球形的中空杯构成，其侧面上开有一条狭缝41，该狭缝的宽度为e。在制造的过程中，宽度e的初始值为eini。在采用温度T1进行培养期间，使得窝槽呈现第一几何状态，在该状态下的宽度值e为e1。例如，该e1值要大于eini。
在采用温度T2进行培养期间，使得窝槽呈现第二几何状态，在该状态下的宽度值e为e2，由于和上述销钉30相同的原因，该值e2要略微比值e1小一些，但是又比值eini大一些。
所述窝槽的使用方法如下。和前面一样，将窝槽置于关节腔中，并受热，使其温度达到T1。假设其随后处于第一几何状态，在该状态下狭缝41的宽度值为e1，使其自身固定在关节腔的侧壁上。如果温度T1较高的话，热量可以通过透热刀来提供。
一旦就位后，窝槽就会保持固定。
当要将其拆下时，使其受热并使其温度达到T2，在该温度下，窝槽呈现第二几何状态，该状态下狭缝41的宽度为e2。该宽度值e要略微低于第一几何状态下的宽度值e1，这样在将窝槽抽出时就能避免损坏任何向内生长的组织。
用具有两种记忆工能的材料制成的所述窝槽除了具有采用本发明的工艺方法所显示出的优点外，其插入时比需要采用螺钉或石膏的现有技术要简单和快捷。而且，如果采用螺钉，那么作用在窝槽聚乙烯芯件上的摩擦是产生不可忽视的磨损的根源。
需要指出的是，窝槽40上可以设有一条或多条象狭缝41一样的狭缝。
本发明还能够应用到作为跖趾假体的植入物上。
本发明也可以用于腰椎外科栓结术以使得椎骨重新对齐，这些椎骨采用双记忆材料做成，并使其进记住两种独立的几何状态：一种状态用于在椎骨之间进行栓结而另一种状态使其能拆卸下来。
本发明还可以用于一种锚钉假体，例如一种膝盖假体，如图4a-4c所示。这种锚钉50大致呈圆柱形，且在圆柱体的顶上覆盖着一个用来容纳假体端部的半球形杯体51。需要指出的是，该杯体51可装备一种假体固定装置，例如一种刺刀或其他的配件。
在锚钉50的圆柱形部分中，切出一些凸块52，这些凸块52通过其挠性基部54与锚钉的本体53结成一体。因此，每个凸块都能够相对于其基部54向外弯曲。
图4b所示的是锚钉50的俯视图，该锚钉的凸块52向外弯曲。锚钉50的这种状态为第一几何状态，且该状态与通过对锚钉加热将锚钉插入时所给定的状态一致，锚钉通过加热而达到接近温度T1的温度。
在图4c中，锚钉50的凸块缩回并靠在锚钉杆上。锚钉50的这种状态为其第二几何状态，该状态与通过对其施加必要的热量而将锚钉拆下来时所给定的状态一致，锚钉通过加热而达到接近温度T2的温度。
现在参考图5对本发明的另一种应用进行描述，该图涉及一种股骨茎元件装置。该装置由一种平杆60构成，该杆的一端装配有一中心圆柱61，该中心圆柱以其现有的方式直接或借助于一种套筒用来装配到一个球形件中，该球形件用来形成股骨假体的头部。该装置还包括一个模具62，该模具与杆60相适应并覆盖在该杆。在该实施例中所示的该模具62有两个通过一中心部分62c彼此连在一起的侧壁62a和62b。
模具62由记忆材料制成，并根据本发明的工艺方法受到两次培养。在初始状态下，侧壁62a和62b彼此平行，且两侧壁之间分开的距离d的值为dini，dini略微比杆60的厚度要大，从而所述模具62可以安装在所述杆60上。在第一几何状态下，侧壁62a和62b彼此相向稍微拉近一些，因此距离d的值要小于dini且也略微小于杆60的厚度。在该几何状态下，通过简单的夹紧方式就可将模具62插入和固定在杆60上，插入时的温度为T1。在第二状态下，侧壁62a和62b彼此基本平行，因此距离d的值基本上等于初始值dini，且在该状态下可以在温度T2下将模块62从杆60上拆卸下来。

Claims (14)

1.使一种由形状记忆合金记住两种几何状态的工艺方法，该工艺方法包括：
a)通过对所述的产品进行作用而使所述合金记住第一几何状态，使之在第一温度下达到第一状态并使之在第一温度下保持所述第一状态，然后
b)通过对所述的产品进行作用而使所述合金记住第二几何状态，使之在第二温度下达到第二状态并使之在第二温度下保持所述第二状态。
2.如权利要求1所述的形成记忆的工艺方法，其特征在于该方法还包括：采用其化学计量比接近于1的镍钛合金作为合金，或者采用一种由所述合金进行加强后的复合材料。
3.如权利要求1或2所述的形成记忆的工艺方法，其特征在于，所考虑的两个温度中的最高温度在+37℃到+55℃范围之间，而最低的温度在+30℃和-30℃之间。
4.如前述任何一个权利要求所述的形成记忆的工艺方法，其特征在于，所述第二几何状态为所述产品受到首次培养之前的初始状态。
5.如前述任何一个权利要求所述的形成记忆的工艺方法，其特征在于该方法包括：在对所述合金进行第一几何状态的培养之后和在对所述合金进行第二几何状态的培养之前，对所述产品进行精加工。
6.如权利要求5所述的形成记忆的工艺方法，其特征在于，所述精加工步骤包括，例如通过喷砂的方式进行抛光。
7.如权利要求5或6所述的形成记忆的工艺方法，其特征在于，所述精加工步骤包括：在低温下沉积出一层薄的保护层，该保护层由下列材料中的一种构成：
碳化镍
碳化钛
氮化钛
氧化铝
二硫化钼
碳氮化钛(腈化钛)
镍、钛以及铝的三元材料
氮化铬
非晶态的黑金刚石
8.将如权利要求1-7中的任何一个所述的形成记忆的工艺方法应用到一些产品上，这些产品将要通过紧固的方式固定到一元件上，之后又从该元件上拆下来。
9.如权利要求8所述的形成记忆的工艺方法的应用，其特征在于，所述产品是人体植入物。
10.如权利要求9所述的形成记忆的工艺方法的应用，其特征在于，所述人体植入物是一些联结夹，这些联结夹包括两个由一中心连接在一起的支腿，所述两支腿在第一几何状态下彼此相向拉近，而在第二几何状态下彼此基本上平行。
11.如权利要求9所述的形成记忆的工艺方法的应用，其特征在于，所述植入物由一管构成，该管的侧面至少开有一条纵向槽，所述管在所述第一几何状态下要比初始状态下开口要大些，且在所述第二几何状态下，该管处于类似第一几何状态的状态，该状态下其开口相对于初始状态也要大一些。
12.如权利要求9所述的形成记忆的工艺方法的应用，其特征在于，所述的植入物是窝槽，该窝槽由一种半球形的中空杯构成，该中空杯其侧面上开有之少一条狭缝，该狭缝在第一几何状态下的开口度要比在第二几何状态下宽。
13.如权利要求9所述的形成记忆的工艺方法的应用，其特征在于，所述植入物为锚钉，该锚钉基本上呈圆柱形，该圆柱形的侧壁上有纵向的凸块，这些凸块可以相对于其基部向外弯曲，所述凸块在所述第一几何状态下处于弯曲位置，而所述凸块在所述第二几何状态下则顺着所述圆柱形的侧面放置。
14.如权利要求8所述的形成记忆的工艺方法的应用，其特征在于，所述产品是一个具有“U”形断面的模具，该模具可以安装到一平杆上，从而形成一股骨茎，所述模具的侧壁在所述第一几何状态下彼此相向拉近，而在所述第二状态下彼此基本平行，所述侧壁在所述第一几何状态下夹紧所述平杆，从而通过夹紧的方式使其固定。
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