CN1053005A - 矫形器的改进 - Google Patents

矫形器的改进 Download PDF

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CN1053005A
CN1053005A CN90109860A CN90109860A CN1053005A CN 1053005 A CN1053005 A CN 1053005A CN 90109860 A CN90109860 A CN 90109860A CN 90109860 A CN90109860 A CN 90109860A CN 1053005 A CN1053005 A CN 1053005A
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orthosis
foot
footwear
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metatarsal
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菲利普·约翰·瓦希利
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Winpal Pty Ltd
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Abstract

一种可塑外形的矫形器，长度约为与之配合的鞋 (靴)长度的四分之三，它有一个整体制成的脚跟套 (2)，一个纵向拱形突起(3)一个跖骨部突起(4)和一 个内凹突起(θ)。将该矫形器放进鞋(靴)中直到后跟 部，然后加热之，患者将脚伸入鞋(靴)中，这时柔软的 矫形器即被模塑，适应于患者的脚。

Description

本发明涉及矫形器，特别是一种可以被模制成适合患者脚的状态以支撑和调节脚的骨骼结构的矫形器。
所谓“矫形器”是公知的，它们包括从简单的鞋内底成形到豪华的结构的定制矫形鞋制品。
拆开矫形，我们可看到公知的可插入的鞋垫装置的尺寸通常复盖鞋底的整个表面，这就要求具有多种不同长度，宽度甚至形状的鞋垫，如女士用的轻便半高跟鞋（court-fit  shape）。这些公知的鞋垫通常都有现货供应，但它们要么无力从生物力学角度上调节人的脚，要么这种调节和适应患者脚型的过程耗时甚长。这些鞋垫很少能从生物力学角度对脚的骨骼进行今人满意的控制，且通常它们是由硬材料如硬塑料或碳纤维制成的，另一方面，很多用弹性材料制成的鞋垫也仅仅起到减震作用。
“全鞋长”矫形器在下列美国专利中均有公开：第3895405号（EDWARDS）中，鞋垫由平片状原始材料模压而成（见图1和图2）;第3782390号（JOHNSON）介绍了一种制造插垫物的方法，即向脚8所穿的鞋12中充入可贮存的液体;第2760281号（COSIN）公开了一种鞋垫或插入物，由若干不连接层组成，包括被加入在内的三角形构件15;而第2409594号（SHERMAN）则公开了一种由片状材料制成的矫形器，该种材料可使用活化剂使之最后形成固定形状。
美国专利4674204号，4232457号，3825017号和4522777号（SULLIVAN，MOSHER，SCRIMA，和PETERSON）分别公开了具有海绵或泡沫层的各种矫形器。
第2401514号美国专利（SCHOLL）提出的一个创造性的概念是，将一个纤维质条状物置于热塑树脂的拱形支撑下面，以防止其在穿鞋时滑动和发出吱吱声，第4517981号美国专利（SANTOPIETRO）涉及一种基本上平的、四分之三鞋长的矫形器，它没有纵向拱起或跖骨都突起。第4823420号美国专利（BARTNECK）公开了一种包含数层材料的模制成形的鞋垫，它明显不足四分之三鞋长，并且直线地横切下没有跖骨凸起的前端部。
其它感兴趣的是下列号码的美国专利说明书：
2653396（GOTTLIEB）;3068872（BRODY）;3121431（ROSENHAFT）;3859740（KEMP）;3309797（POATIS）;4216778（WEISS）;4268980（GUDAS）;4346525（LARSEN）;4364188（TURNER）;4463761（POIS）;4520581（IRWIN）;4530173（GESINSKY）;4557060（KAWASHIMA）;4563787（DREW）;4674201（WEISS）;4686993（GRUMBINE）;4702255（SCHENKI）;4756096（MAYER）;4791736（PHILLIPS）;和4868945（DE，VETTIGNIS）;
本发明的目的是，克服或至少减少已有技术的不利方面或缺点，首先，提供一种外形可模制的矫形器，这种矫形器有预定的各种形状和角度，能够被插入鞋中置于鞋底面上且能够最后被模制成适合患者脚的形状，从而支承和调节脚的骨骼结构，这种可塑矫形器大约有鞋的四分之三长，以便支承于踵骨到接近跖骨的末端部位，该矫形器带有一个整体模制的脚跟套，一个纵向拱形突起部，一个约4°的内凹部以及一个使第一，第二，第三和第四根跖骨顶端成为一条直线排列的跖骨部突起。
最理想的是，该可塑矫形器的宽度正好是第五条跖骨端的侧面到第一和第二根跖骨的纵向等分线的距离。这种设计使得当患者用脚踏时，第一跖骨节能够产生弯曲。
“突起”和“弯曲”这两个词对于熟悉矫形器领域的人来说，是有深刻理解的。
其次，本发明提供一种方法，使可塑矫形器在患者脚下最终成形，这种方法包括以下步骤：
（Ⅰ）将该可塑矫形器插入选择出的鞋中;
（Ⅱ）将矫形器置于直抵后跟的位置上，以使之复盖鞋底该部分表面;
（Ⅲ）用蒸汽加热该矫形器，在一个连续的循环中，先是约5秒钟的“接通热源”，接着是约5秒钟“切断电源”，然后重复这一过程，直到该矫形器经过约20秒钟的加热过程。
（Ⅳ）患者坐着将脚伸入鞋中;
（Ⅴ）摸索着调整脚底关节于一适中位置;
（Ⅵ）患者站立，保持脚底关节的适中位置，使双脚受力均匀，将鞋的中间和侧边向内压，使尚热的，可塑的矫形器形成患者的脚所处的适中的状态，然后
（Ⅶ）使该矫形器冷却。
为使本发明被更好地理解，在下文中我们通过参考附图来说明一个优选的实施例。
图1是一个左脚的可塑矫形器的右侧视图;
图2是底视图;
图3是该矫形器的左视图;
图4是顶视图;
图5是正面透视图;
图6是另一个实施例的脚跟部分底面局部图，其中有一个吸收冲击的海绵质的“冲击点”插入物;
图7是沿图6中的Ⅶ-Ⅶ线取的按比例放大的横截面图。
在各附图中，同一数字表示类似的部分，在说明书中，形容词“orthotic”代替“orthopodic”或“orthopaedic”来修饰“device”。
各附图中有一个通常由1表示的可塑矫形器，它可以是由比重为350公斤/米3的乙基己烯基己酸酯（E、V、A）或比重为220公斤/米3的乙基己烯基己酸酯（E、V、A）制成。
表格：
性能及检验方法  单位  “EVA”  “EVA”
密度 kg/m3350 220
硬度（日本工业标准Typec）  -  74  57
吸水平（日标.K6767） gms/cm3＜0.002 ＜0.002
导热率（美国试验标准578）  w/m℃  0.064  0.055
操作温度  Min℃  -70℃  -70℃
max℃  -70℃  -70℃
拉伸强度（日标K6767）  Mpa  3.0  2.0
撕破强度（日标K6767）  N/cm  170  120
断裂伸度率（日标K6767）  %  250-300  250-300
压缩塑性变形率  %  ＜5  ＜5
压缩偏转（美国试验标准  kpa  950  240
d3575）
本发明的可塑矫形器可做成各种几何形状，也就是说，有各种形式，用于正常成年人的，女式轻便半高跟鞋用的，婴儿或年青人用的。儿童脚的尺码范围可设想为，比如1-3、4-6、7-9、10-12，及13，青年人的尺码2，从一般的和更广泛的适用性出发，我们即可提供10种模型。同样，假设成人的尺码为4-6，7-9，和10-12，在正常的、宽的和女式轻便半高跟鞋等方面，在此范围内提供了9种成年人用的模型。
每个可塑矫形器1是通过一种阳摸用EVA制成，这些阳模与矫形器形状相同且都是刚性的。本发明的矫形器的长度大体上是鞋内部实际长度的四分之三，以便可以垫于踵骨（即跟骨）下而截止于靠近跖骨顶端的部位，这些跖骨位于趾骨和连接脚的7个跗骨之间。
每个可塑性矫形器都有一个整体摸制的足跟套2，纵向拱形突起部分3和为校直第2、3、4根跖骨顶端成一行而做的跖骨突起部4。
本发明的矫形器的宽度最好是从第5根跖骨突出部的侧面起到第1与第2根跖骨的纵向等分线止，这种设计使第一根跖骨在脚用力踏或说走或跑一时能够弯曲。如必要，也可增加一个楔形物和/或其它几何形状的结构，用以校正前脚掌的，跗骨的或脚踵的严重畸形。
可以想象，至少在开始阶段，熟练技术人员将在现有的预制铸造模中进行定制的模制这种可塑矫形器，但是，可以说，长期的生产过程将利用其本身的“cad/cam”加工工艺与工业模制工艺技术应用相结合进行生产。
对于脚的某些畸形，本矫形器还有一些可模制的附件，包括2°，4°、6°、8°的可粘合的楔形块，4或8毫米的可粘合的踵部突起和纤维复盖物。
图3的角θ所示的是一个4°角（或接近4°角）的脚底部后部突起-即所谓的“内凹突起，这种构造即可允许脚部弯曲又可防止过度内翻。
在一种改进型中，已摸制好的矫形器中可加入一海绵质减震垫5（最好由低密度的聚氨基甲酸酯泡沫做成），该减震层正好垫在后跟骨刺或跟骨下。这个插入层5可以被恰当地称为“震点”或“震位”。该矫正器的缓冲区域可以是其整个厚度部分或部分厚度部分。最好将矫形器的表面用一层纤维外层覆盖或包住-见图7中的6。
另一方面，如前所述，本发明提出了一种方法，即当矫形器被插入鞋中并置于鞋底上后，可以在鞋中就患者的脚模制而成。
模制过程如下：将本发明的可塑矫形器插入选择好的鞋中。置于尽量靠后的位置，利用合适来源的蒸汽加热该矫形器，使用一个连续约5秒钟的“接通热源”和约5秒钟的“切断热源”的加热循环，重复这个循环，直到该矫形器经过约20秒钟的总加热时间，患者坐着将脚伸入鞋子或靴子中，摸索着调整脚底关节于一适中位置，然后让患者站立，保持脚底关节的适中位置，使双脚受力均匀，将鞋的中间和侧面边缘向里压，使尚热的，可塑的矫形器形成患者的脚所处的适中的状态，只需使矫形器冷却约5分钟，或冷却至环境温度。这鞋或靴就可以穿了。
如必要，另一只脚也需重复这一过程。可是在模制矫形器的过程中为保证平衡，两只鞋都要穿上。如需要，在模制的下个过程中，前脚掌的突起可以踩在跖骨边的矫形器边缘上，而且，如果未达到所需要的结果，矫形器可以很容易地重塑。
本发明较已有的各种矫形器有几项明显的优点：高而坚实的脚跟套对脚后部有更好的控制;装入了一个“震点”垫层;为适应跖骨的矫形、纵向拱起的矫形、横向拱起的矫形及矢状跟骨的矫形而准确的成型;因后跟部表面较宽和固体的EVA的基底而更稳定，有最好为4°角的向内凹突部。
实验表明，本发明对于下列一般脚部生理问题能提供有效的帮助：踵部骨刺，足底筋膜炎、摩顿氏病、脚趾触痛、跟骨骨突炎、跟腱苔色素感染、外肿夹、过度内翻、膑骨运动障碍、平足，及矫形外科方面类似的问题。
综上述，本领域的技术人员将懂得，按照下述权利要求中所阐述的原则和范围。可以对本发明的矫形器做出一些改形和改进。

Claims (10)

1、一种外形可塑的矫形器，它有预定的各种形状和角度，能够被插入鞋中置于鞋底面上而最终能够在鞋中被模制成适合患者脚的形状，从而支承和调节脚的骨骼结构，这种矫形器大体上为鞋的四分之三长，置于患者脚的后跟到邻近跖骨顶端的部位，它带有一个整体模制的脚跟套，一个纵向拱形突起部，一个约4°的内凹突起以及一个使第一、二、三和四根跖骨顶端成为一条直线排列的跖骨部突起。
2、如权利要求1所述的可塑矫形器，其宽度是第五条跖骨端侧到第一和第二根跖骨的纵向等分线的距离，这使得患者用脚踏时，第一跖骨节能够产生弯曲。
3、如权利要求1或2所述的可塑矫形器，其中装有海绵质减震插入件，垫于患者脚的跟骨骨刺下。
4、如权利要求3所述的可塑矫形器，所说的缓振区可以是矫形器整个厚度部分或部分厚度部分。
5、如权利要求1或2的可塑矫形器，其上表面套有一纤维状表皮。
6、如权利要求1或2的可塑矫形器，乙基烯基乙酸酯制成。
7、一种在鞋中按照患者脚型模制如权利要求1或2所述的可塑矫形器的方法，由以下几个步骤组成：
（Ⅰ）将该可塑矫形器插入选择出的鞋中;
（Ⅱ）将矫形器置于直抵后跟的位置上，以使之复盖鞋底该部分表面;
（Ⅲ）用蒸汽加热该矫形器，在一个连续的循环中，先是约5秒钟的“接通热源”，接着是约5秒钟“切断电源”，然后重复这一过程，直到该矫形器经过约20秒钟的加热过程。
（Ⅳ）患者坐着将脚伸入鞋中;
（Ⅴ）摸索着调整脚底关节于一适中位置;
（Ⅵ）患者站立，保持脚底关节的适中位置，使双脚受力均匀，将鞋的中间和侧边向内压，使尚热的，可塑的矫形器形成患者的脚所处的适中的状态，及
（Ⅶ）使该矫形器冷却。
8、如权利权利要求7所述的一种方法，其中所说的矫形器冷却时间为约5分钟。
9、如权利要求7所述的一种方法，其中所说的矫形器可以冷却到环境温度。
10、如权利要求7所述的一种方法，按步骤（Ⅵ）之后，将前脚掌和/或后脚掌凸起压到矫形器跖骨边缘上。
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CA2072133A1 (en) 1991-05-18
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