CN106470645B - 打孔的衬垫 - Google Patents
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Abstract
本发明涉及一种用于穿戴在肢体残端上的假肢衬垫,该假肢衬垫具有由弹性体构成的弹性衬垫层(20),在此,该衬垫层(20)至少在远端部分(30)中具有孔隙(26)。
Description
技术领域
本发明涉及一种经过改进的、用于穿着在肢体残端上的假肢衬垫。本发明还提出了对假肢穿戴的改进。
背景技术
缺损的身体四肢可以用假肢来代替。假肢在此模仿(nachbilden)缺损肢体的功能和/或形状。为了在假肢与肢体残端(例如,截肢或关节截断之后的小腿残端或大腿残端)之间实现机械连接,假肢具有所谓的假肢杆,假肢杆接收肢体残端并将假肢尽可能地形状配合和力配合地固定在肢体上。如果情况允许,还可以使用带子和类似的器件来防止假肢轴从肢体残端滑落。
为了将假肢杆固定到肢体残端上,在此特别是设置有长袜形的所谓衬垫。这种衬垫公知地是由肖氏硬度A为20至约50的弹性材料、硅橡胶或聚氨酯基或氯丁二烯基的聚合物制成,特别是RTV硅。在穿戴假肢之前,假肢衬垫被拉至肢体残端的上方并在身体与假肢杆之间形成粘附、密封和缓冲的中间层,该中间层补偿在穿戴过程中可能出现的配合不准确性并同时增加穿戴舒适性。
在假肢杆的一种设计方案中,该假肢杆被特殊地成形到肢体残端上,使得支持固定。通过以假肢杆与肢体残端的皮肤表面之间的增加附着力的层来提高静摩擦的方式,来实现力配合。在此利用的是:在将假肢杆戴到肢体残端上时将空气压出,通过肢体残端与假肢杆之间的表面的相当程度的密封作用,使得空气不再能够容易地流回,从而能够实现粘附。
在一种可替代的但本质上与此同源的原理中,主要用到了衬垫的弹性体材料的表面特性,该表面特性在肢体的尤其是无毛的皮肤表面上造成较高的摩擦。已知地,某些弹性体、例如硅橡胶或聚氨酯基或氯丁二烯基的聚合物关于皮肤具有特别紧密的粘附性,特别是当弹性体尤其是由于其自身的弹性而被压到皮肤表面上时。已知的假肢衬垫(在被裸露的肢体残端预紧的情况下)容易地粘附在残端上,并可以在那里吸收大量的剪切力。通过另外的措施和器件,使粘附的衬垫与刚性的假肢杆机械地连接,例如通过衬垫上的远端金属基底,该金属基底利用相应的结构,力配合和形状配合地接合在假肢杆上。由此,即使在残端与杆之间没有根本形成真空,假肢也牢固地保持在残端上。
为了实现粘附,假肢衬垫由至少一个不透气的固体材料层构成,该固体材料层将肢体残端和假肢杆内侧针对外部环境密封,以形成真空。已知的由弹性体材料制成的假肢衬垫的缺点在于:密封的弹性体或橡胶和皮肤组织的表面通常是不相容的。在穿戴时,由于活着的皮肤中的皮脂腺和特别是汗腺的不可避免的活动,在肢体残端的皮肤与假肢杆的内侧之间会不利地出现液体。这会导致在穿戴时出现主观的不适感觉,以及因此降低了针对医疗目的和基于安全原因必需穿戴假肢的依从性。其次,这种液体形成还会不利地导致皮肤表面与衬垫之间的静摩擦减小,由此存在穿戴时假肢杆从肢体残端突然松脱或松动的风险,这对于假肢穿戴者而言会有健康危险,主要是会对假肢、假肢上的可能的人工膝关节失控。这会直接地明显提高在行走时发生摔跤和跌倒的风险。另外,在衬垫与皮肤表面之间缺少粘附时,皮肤表面发生大多数情况下是局部的但却是非常大的摩擦负荷。如果皮肤在此已经被所形成的液体软化,则会刺激和伤害到皮肤。本质上,在皮肤表面存在液体即使在休息时也成问题,因为皮肤表面会受到伤害。尤其是对于伤疤或伤口来说,这是非常关键的。除了一般的刺激和干扰伤口治疗之外,还可发生细菌或真菌类的感染。
发明内容
本发明的目的在于对已知的假肢衬垫进行如下地改进:一方面是保留假肢衬垫的功能,另一方面则是减少或者完全阻止已知假肢衬垫的众所周知的缺点、特别是在肢体残端的皮肤与所穿着的假肢衬垫之间的液体形成。
为此目的,本发明提供了一种用于穿着到肢体残端上的新型假肢衬垫。根据本发明,该假肢衬垫具有至少一个由弹性体制成的弹性衬垫层,根据本发明,该衬垫层至少在肢体残端的远侧前端的区域中具有孔隙,并且孔隙在所述衬垫层的松弛状态下基本上是封闭的,而在运动时通过所述衬垫层在残端上拉伸能够打开。
在此,优选地设置为,这些孔隙在衬垫层的松弛状态下基本是封闭的,并且通过衬垫层的拉伸而被打开。这种拉伸特别是发生在下述情况下:假肢衬垫被穿着在残端上,假肢被戴上并且假肢穿戴者以通常的方式使用假肢,即,在肢体与假肢杆之间发生横向力和剪切力。例如,在小腿假肢或者大腿假肢中,在行走时衬垫层会周期性地拉伸和松弛,由此使根据本发明的孔隙相应地或多或少地进一步打开或封闭。
根据本发明的假肢衬垫具有孔隙,这些孔隙能够至少暂时性地在衬垫的面向残端的内侧与外侧之间建立透气性和透液性的连接。
很明显,通常不利地在肢体残端的皮肤与假肢衬垫的内侧之间形成的液体、也就是说特别是汗水,会通过根据本发明的孔隙穿过衬垫层向外排出,即离开皮肤表面。有利的是,这种排水特别是发生在运动过程中,也就是在假肢衬垫的拉伸过程中。在不受到理论束缚的情况下,希望通过衬垫层的固有弹性和根据本发明的孔隙的横截面依赖于拉伸的改变的相互作用,来实现一种泵送效应,这种泵送效应使所形成的液体优选地积极地向外移动。有利地,由此避免自然形成的液体、也就是说特别是汗水过度地积聚在肢体残端的皮肤表面上。这使假肢穿戴者直接感觉到明显地增加的穿戴舒适度。同时,由此使假肢的运行可靠性和使用寿命显著增加。
令人惊讶的是,与预期相反,根据本发明的孔隙不会降低另外所力求的、假肢杆在肢体残端上的真空粘附性。相反,与预期相反的是,通过孔隙主要是由于有利地排出了液体,使得假肢衬垫的增加附着力的作用得以提高。
在一种优选的设计方案中,孔隙仅设置在假肢衬垫的远端部分中,即,肢体残端的前端区域中。在一种替代的设计方案中,在假肢衬垫的远端部分中的局部密度、也就是每单位面积的孔隙的数量,要高于假肢衬垫的其他部分。在一种优选的变型中,替代地或附加地,在假肢衬垫的近端部分不存在孔隙。
在另一种变型中,孔隙分布在整个衬垫表面上。在另一种变型中,孔隙被局限于某些与优先的(darunter liegenden)肢体的解剖学的结构相对应的区域中,即,仅唯一地存在于那里,或者以较高的密度存在于那里。这些区域特别是在皮肤的汗腺密度较高的地点上。相反,在衬垫的某些区域中,例如由于稳定性的原因,就没有孔隙。这些区域特别是具有高机械拉力负荷的区域,例如在髌骨、前胫骨边缘或者髁骨的区域中。
“远端部分”是指假肢衬垫的如下区域:该区域关于假肢衬垫的总拉伸沿纵向方向延伸经过假肢衬垫的远端侧的70%、优选为66%、特别优选为40%。“近端部分”是指假肢衬垫的如下区域:该区域关于假肢衬垫的总拉伸沿纵向方向延伸经过假肢衬垫的近端侧的70%、优选为50%、特别优选为30%。
优选地,衬垫层中的孔隙的平均密度为每平方厘米面积有2至20个、特别为每平方厘米面积4至16个。与此相反,“高密度”部分的密度为每平方厘米有大约8至20个孔隙;在此,低浓度区域的密度为每平方厘米有大约2至8个孔隙。
在此,根据本发明的假肢衬垫可以由所有已知的、应用于假肢衬垫中的已知弹性体材料构成。优选地,至少一个弹性衬垫层由从硅弹性体(硅橡胶)、聚氨酯弹性体、氯丁二烯弹性体中选出的弹性体构成。特别优选为硅弹性体,特别是RTV硅。肖氏硬度(A)优选为20至50。衬垫层的厚度优选为2mm至4mm,在所谓的凝胶衬垫(Gellinern)中厚至6mm。
在特别优选的设计方案中,衬垫层中的孔隙是通过无削方法形成的。优选地,选择例如割开或刺扎这样的处理步骤。这特别是通过使用刀和/或针来完成。通过这种无削方法形成的孔隙特别是确保:这些孔隙在假肢衬垫的放松、非拉伸状态下基本上处于封闭状态,并且只有通过拉伸应力才能被打开。因此,在本发明的思想下,特别良好地确保衬垫层的阀门效应。
在替代的设计方案中,根据本发明的衬垫层中的孔隙通过所谓的切削方法形成。优选地,这些方法选择冲孔和钻孔这样的处理步骤。切削方法被理解为材料切除方法。即,在这种设计方案中,孔隙是在有材料损失的情况下呈孔的形式形成在衬垫层中。
在一种替代的设计方案中,通过切削方法形成的孔和通过无削方法形成的细口在衬垫层中组合地存在。
在一种优选的变型中设置为,孔隙仅仅地或替代地以高密度地设置在假肢衬垫的衬垫层的下述区域中:该区域在穿着状态下可以定位在肢体残端的存在有高密度汗腺以及因此预计形成有更多液体的区域上。在一种替代的或附加的设计方案中,孔隙仅仅地或替代地以高密度地位于衬垫层的下述区域中:在穿着状态下以及在通常的使用中,由于重力矢量使所形成的液体积聚在假肢衬垫的内侧。例如在大腿假肢或小腿假肢中,该区域可以是肢体残端的远侧尖端。
在一种替代的或附加的设计方案中,根据本发明的孔隙在衬垫层中被构造为呈微孔隙的形式,衬垫层本身是开放多孔的弹性体海绵材料或者含有这种弹性体海绵材料。在这种设计方案的一种变型中,衬垫层不仅具有开放多孔的部分,而且还具有封闭蜂窝状的部分和/或无蜂窝的部分。从制造技术上说,这可以例如通过将含有海绵材料和不含有海绵材料的弹性体前体组合浇注成相应的形状来实现。在此还可以考虑,多孔起泡弹性体和通过如前所述的切削和/或无削方法形成的孔隙的组合。
在一种特殊的设计方案中设置为,在衬垫层的外侧上附加地设置纺织材料层。该纺织材料层可以被特别设计为,使在孔隙上的气体交换可能或容易。替代地或者附加地,该织物层可以被专门设计为,接收从孔隙中溢出的液体,并优选继续输送或分散该液体。由此有利地实现:在肢体残端与假肢杆之间的应用,可以相对于周围环境被继续完全封闭,这进一步提高假肢杆的附着力。在此特别设置为,假肢衬垫外侧上的纺织材料将在外侧上局部溢出的液体分散、接收并存储。在已知的过程和措施中,现在例如在假肢穿戴者的休息期内、特别是当没有新的汗液补充形成时,可用作将所形成的液体缓慢地导出或变干。
在该设计方案的一种优选的变型中,织物层被单独地构成,并与假肢衬垫的衬垫层物理地分开,并且可以从衬垫层上拆卸下来。在一种替代的变型中,该织物层与假肢衬垫的衬垫层牢固地连接成一个单元。为此目的,纺织材料可以与衬垫层粘接在一起,或者由弹性体构成的衬垫层被聚合在纺织材料上。
本发明的主题也是,应用具有上述特征的假肢衬垫来达到在穿着假肢时避免或减少在患者的肢体残端上形成汗水的目的。本发明的主题也是,应用具有前述特征的假肢衬垫以延长假肢在患者身上的有效穿戴时间。
下面通过下述的实施例来详细说明本发明,但是这并不能被理解为对本发明的限制。
附图说明
图1以示意图示出了根据本发明的假肢衬垫10的结构
图2示出了图1所示的相应的假肢衬垫10。
图3和图4示出了根据图1或图2的假肢衬垫10的示意性细节视图。
具体实施方式
图1以示意图示出了根据本发明的假肢衬垫10的结构。该假肢衬垫由至少一层由弹性体材料制成的弹性衬垫层20构成。根据本发明,该衬垫层至少在远端部分30中具有孔隙26。假肢衬垫10形成长袜状的套40,该套在近端部分40上具有开口44,该开口被拉到肢体残端上方。
图2示出了图1所示的相应的假肢衬垫10,其衬垫层20至少在远端部分30中具有孔隙26,而不是在可遭受特别的机械负荷的特定的区域34中。
图3和图4示出了根据图1或图2的假肢衬垫10的示意性细节视图。至少在该假肢衬垫的远端部分30的范围内,在衬垫层20中形成孔隙26。图4示出了一种优选的设计方案,其中,衬垫层20朝向外部被由织物材料50形成的附加层覆盖。
Claims (13)
1.一种用于穿戴在肢体残端上的假肢衬垫,具有由弹性体构成的弹性的衬垫层(20),其中,所述衬垫层(20)至少在远端部分(30)中具有孔隙(26),并且其中,孔隙(26)在所述衬垫层(20)的松弛状态下基本上是封闭的,而在运动时通过所述衬垫层(20)在残端上拉伸能够打开。
2.根据权利要求1所述的假肢衬垫,其中,在所述衬垫层(20)拉伸时,孔隙(26)能至少暂时性地在所述衬垫的面向残端的内侧(22)与外侧(24)之间建立透气和透液的连接。
3.根据权利要求1所述的假肢衬垫,其中,在所述衬垫层(20)的外侧(24)上设有纺织材料(50),所述纺织材料被特别设计为,在所述孔隙(26)中能够进行气体交换和/或接收从所述孔隙(26)溢出的液体。
4.根据权利要求3所述的假肢衬垫,其中,所述纺织材料(50)与所述衬垫层(20)物理地分开并且是能拆卸的。
5.根据权利要求3所述的假肢衬垫,其中,所述纺织材料(50)与所述衬垫层(20)牢固地连接。
6.根据权利要求1至5中任一项所述的假肢衬垫,其中,所述孔隙(26)被以平均密度为每平方厘米2至20个孔隙地设置在所述衬垫层(20)中。
7.根据权利要求1至5中任一项所述的假肢衬垫,其中,所述孔隙(26)不存在于所述衬垫的近端部分(30)中。
8.根据权利要求1至5中任一项所述的假肢衬垫,其中,所述弹性体选自于硅弹性体和聚氨酯弹性体。
9.根据权利要求1至5中任一项所述的假肢衬垫,其中,所述衬垫层(20)中的孔隙(26)是通过选自于割开和刺扎的无削方法形成的细口。
10.根据权利要求1至5中任一项所述的假肢衬垫,其中,所述衬垫层(20)中的孔隙(26)是通过选自于冲孔和钻孔的切削方法形成的孔。
11.根据权利要求1至5中任一项所述的假肢衬垫,其中,所述孔隙(26)被构造为,作为开放多孔的弹性体海绵材料的所述衬垫层(20)中的孔隙。
12.根据权利要求1至11中任一项所述的假肢衬垫(10)的一种应用,所述假肢衬垫用于当假肢被穿戴在肢体残端上时避免或减少汗水积聚在肢体残端(40)上。
13.根据权利要求1至11中任一项所述假肢衬垫(10)的一种应用,所述假肢衬垫用于延长假肢的有效穿戴时间。
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US10905568B2 (en) * | 2016-02-29 | 2021-02-02 | Pva Medical, Llc | Prosthetic limb socket with variable hardness |
US11224527B2 (en) * | 2018-01-30 | 2022-01-18 | Alps South Europe, S.R.O. | Interchangeable pump-lock for prosthetic socket and method of use |
US11730612B2 (en) | 2018-12-05 | 2023-08-22 | Ossur Iceland Ehf | Prosthetic liner and method for making the same |
EP4057947A1 (en) * | 2019-11-12 | 2022-09-21 | Ossur Iceland Ehf | Ventilated prosthetic liner |
US20210145613A1 (en) * | 2019-11-18 | 2021-05-20 | Otto Bock Healthcare Lp | 3d printed prosthetic liners and sockets |
WO2023220151A1 (en) * | 2022-05-12 | 2023-11-16 | Alps South Europe, S.R.O. | Novel silicone liner |
WO2024137196A1 (en) * | 2022-12-19 | 2024-06-27 | Alps South Europe, S.R.O. | Novel elastomeric gel liner |
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AU2015293992B2 (en) | 2018-11-08 |
IL249380A0 (en) | 2017-01-31 |
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IL249380A (en) | 2017-05-29 |
CA2953735C (en) | 2018-08-28 |
MX356171B (es) | 2018-05-17 |
DE102014011034A1 (de) | 2016-01-28 |
RU2017105067A3 (zh) | 2018-08-27 |
CN106470645A (zh) | 2017-03-01 |
CA2953735A1 (en) | 2016-01-28 |
US10639173B2 (en) | 2020-05-05 |
RU2665129C2 (ru) | 2018-08-28 |
SA517380742B1 (ar) | 2020-03-22 |
AU2015293992A1 (en) | 2016-12-22 |
DK3171827T3 (en) | 2018-09-03 |
MX2017000847A (es) | 2017-08-18 |
KR101765086B1 (ko) | 2017-08-04 |
ES2682211T3 (es) | 2018-09-19 |
EP3171827B1 (de) | 2018-06-06 |
EP3171827A1 (de) | 2017-05-31 |
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