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CN1245675A - 假肢 - Google Patents

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Publication number
CN1245675A
CN1245675A CN99106979A CN99106979A CN1245675A CN 1245675 A CN1245675 A CN 1245675A CN 99106979 A CN99106979 A CN 99106979A CN 99106979 A CN99106979 A CN 99106979A CN 1245675 A CN1245675 A CN 1245675A
Authority
CN
China
Prior art keywords
artificial limb
series
bonded type
limb
angle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN99106979A
Other languages
English (en)
Inventor
W·普尔
A·德塞萨里斯
M·门兹
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Zimmer GmbH
Original Assignee
Zimmer GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Zimmer GmbH filed Critical Zimmer GmbH
Publication of CN1245675A publication Critical patent/CN1245675A/zh
Pending legal-status Critical Current

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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract

假肢(1)包括基本上圆形截面的远端部分(2),和与这个远端部分(2)连接的近端部分(3),在近端部分的侧面具有一个向腹部伸出的肋骨(4)。近端部分(3)向上扩大。在上端具有一颈部(5),在颈部上可以安放关节头。假肢(1)的直径从假肢(1)的远侧端开始基本上整体锥形扩大。

Description

假肢
本发明涉及到根据独立权利要求前序部分所述的假肢。
在市场上可买到很多不同结构的假肢，特别是这种植入股骨的假肢。根据假肢在股骨内的固定形式和方法可以将假肢区分为粘合式假肢或非粘合式假肢。对此在手术计划中矫形外科医生根据X射线图等获得的骨骼信息，如股骨的大小及其状态来决定，采用粘合或非粘合假肢固定。此外还应确定要植入假肢的尺寸。
在手术过程中从一种确定的固定形式，例如粘合固定开始进行。对于适合这种固定形式的假肢例如由DE-B2-25 37 807或者EP-A-0672 396为公众所知。在手术中首先由外科医生对股骨作好手术准备。在此简单地说是在股骨上做一个孔洞，接着在孔洞内放入粘合剂。然后将假肢插入粘合剂中并保持位置，直至粘合剂固化，并由此使假肢固定。假肢插入粘合剂时必须在没有空气夹杂进粘合剂的情况下实现。这种插入要求外科医生具有一些技巧，因为粘合剂在放入股骨的时候从其流动特性来说是这样进行的，使得实际上不产生已挤出粘合剂的回流。这一点又相应地反映在柄型上，通常情况下粘合式固定假肢柄型与非粘合式固定假肢柄型有着很大区别，因为粘合式假肢的固定是在包围假肢的粘合剂层中实现的，而对于非粘合式固定的假肢固定是直接在包围假肢的骨骼组织中实现的。
在假肢植入时采用粘合式还是非粘合式固定进股骨的决定已经在手术之前，即在预定手术方案中已经确定。关于要植入假肢的大小在手术前也已经确定。同时还决定了，外科医生得如何做出用来容纳粘合剂的孔洞以及孔洞必须具有什么样的尺寸。
然而在一些情况下在手术进行当中表明，即在对股骨实施预备措施时，例如由于骨质状态应该预定进行非粘合式固定，甚至是很适合预定进行非粘合式固定，尽管计划进行粘合式固定。但是此时改变粘合式假肢的决定已不再可能，因为根据粘合式和非粘合式固定假肢的不同柄型必须产生新的手术计划。
因此本发明的任务就是建议一种假肢，它能够实现，对已经在手术计划中产生的关于固定的决定可以再改变一次，而无须对此要求新的手术计划。这一点换句话说就是，假肢就其柄型来说不仅得适合于粘合式固定而且也得适合非粘合式固定。
按照本发明这个任务通过独立权利要求特征所表示的假肢而被解决。尤其是按照本发明的假肢具有一个基本上为圆形截面的远端段。也就是说，这个远端部分首选由完整的圆形构成，但是可能有一点圆形偏差，例如有一点扁平，以保证在粘合式固定时有足够厚的粘合层。在这个远端段上连接有近端段，在此近端段侧面上还有一向腹部伸出的肋骨。假肢的近端段向上扩展，并且在上端部位形成一颈部，在颈部上可以放置关节头。假肢的直径从假肢的远侧端开始基本上整体锥形扩展，首选整体锥形。这种形式的假肢原则上不仅适合于粘合式而且也适合于非粘合式固定在骨骼中。
从假肢远端开始的基本上整体锥形扩展意味着，假肢不存在后切除，这种后切除以往在粘合式固定过程中由于骨骼粘合剂的不良流动特性(粘滞性)而可能导致空气夹杂。此外假肢在近端方向上的扩大导致骨骼粘合剂的压迫并由此改善粘合剂在骨骼孔洞空间内渗透进经常是多孔的骨骼(海绵组织)的分布。此外从假肢远端开始的锥形扩展对应于骨干骨骼部位内骨髓腔的自然走向。对于带有非锥形的圆柱形远端部的假肢可能在非粘合式固定时有时侯出现这种假肢卡住，但是非粘合式固定应首选在近端的假肢区域上实现。这种卡住对于外科医生来说意味着附加的工作步骤，因为他还得用准备好的锥状铰刀对骨髓腔进行附加的扩孔，以使假肢能够被更深的插进骨髓腔，由此使假肢能够被固定在近端区域上。
在按照本发明的假肢的优选实施例中锥形扩大的远端段的张开角在1°至10°范围内，特别是位于大约2°。这个范围实际上包括了在骨干骨骼区域内所出现的所有骨髓腔走向，很多走向都具有2°张开角。
在按照本发明的假肢的另一优选实施例中假肢纵轴与颈部轴之间的夹角在120°至150°之间，特别是位于大约135°。对于这种角度人们也称之为所谓的“CCD角”(椎体-颈-骨干角Centrum CollumDiophysis angle)。上述范围同样基本包括了在实践中所出现的情况。135°的CCD角经常在年轻患者中见到，但是这种尺寸的CCD角的假肢也完全可植入更大年龄的患者。这样的CCD角也可以影响到例如局部肌肉韧带器官的绷紧，因为在患者骨骼上的原始CCD角在假肢植入前是较微小的，通过较大的CCD角韧带器官又被“张紧”。
在按照本发明假肢的另一实施例中假肢在近端段向前倾斜，在此这个倾斜角度或者前倾角度(前倾角度是经常出现的标法)位于5°至17°之间，特别是位于11°左右。这个角度范围包括了最经常出现的前倾角度，对于这个角度经常出现的值为大约11°。
本发明的另一方面涉及一系列不同尺寸假肢，其中这种系列中的每个假肢由前面所述的结构而构成。不同尺寸的假肢是按照“洋葱皮原则”而构成的，在此两个相邻尺寸的厚度值相差一个恒量。两个相邻尺寸的长度值同样也可以差一个恒量，但是这个恒量可能与厚度差恒量不同。
在粘合式固定中关于包围植入假肢的粘合层厚度存在着不同的观点，这种观点从很薄的粘合层(例如十分之几毫米)到较厚的粘合层(例如从1毫米直至3毫米)。在此粘合层被解释为由粘合剂所充填的植入孔洞与假肢之间的空间。粘合剂挤入海绵组织在实践中可以导致这个粘合层的加厚是显而易见的。尤其是鉴于后一种观点(较厚粘合层)本发明的另一个方面涉及到一套假肢，这套假肢包括两个假肢系列，第一系列和第二系列，其中各系列中的每个假肢由前面所述结构而构成。在第一系列中假肢用于非粘合式植入，在第二系列中假肢用于粘合式植入。在不同系列的假肢中一个系列的柄型和尺寸与对应的另一系列的假肢是一致的，但是第二系列(粘合式固定假肢)中的那个对应于第一系列非粘合式植入假肢的假肢小于对应的在第一系列中的那个假肢。仅仅是第二系列(粘合式固定假肢)的假肢颈部大体上对应于第一系列(非粘合式固定)对应的假肢颈部尺寸，因而从假肢颈部来说尺寸大体上是与非粘合式固定相同的，但是粘合式假肢本身小于相应的非粘合式固定假肢。
本发明的其它有利结构通过下面参考附图所述实施例给出。图示有些为简图和/或截面图：
图1为按照本发明的假肢实施例的透视图，
图2为图1所示假肢实施例的从腹部看过去的视图，
图3为图1所示假肢实施例从侧面向中心看过去的视图，
图4至8为图2假肢实施例沿剖面线IV-IV，V-V，VI-VI，VII-VII，VIII-VIII的截面图。
在图1中给出了按照本发明的假肢实施例由中心/腹部方向看过去的透视图。假肢1包括一个远端段2和一个与这个远端段连接的近端段3。在近端部分3的上端有一个孔洞30用于非粘合式固定楔入器械的连接或者粘合式植入顶压器械的连接。在侧面在近端部分3上向腹部方向伸出一个肋骨4。这个肋骨4以大体上解剖学上的骨骼构造仿制在侧面部位。在假肢1的近端部分3的上端部位连接着颈部5，在颈部上可以安置一个关节头(没有画出)。这一点在所示实施例中是这样实现的，与一个锥形盲孔一起形成的由适当材料(如陶瓷或金属)制成的关节头推到锥形延伸的颈部部分50上并且通过锥形夹紧座固定在颈部部位50上。
在图2中给出了图1所示假肢1实施例的从腹部看过去的视图。在此也可以看到假肢1的远端部分2和与远端部分连接的近端部分3。此外还看到朝着腹部(即假想由图示平面突出的)的肋骨4和连接在近端部分上部的颈部5。此外在图2中还看到，假肢的直径从假肢远侧端开始整体扩大。这一点在图2中借助于张开角α来表示，这个角度范围位于1°至10°，特别是位于2°左右。应这样来设想图2中的张开角α，即不仅将两根画在假肢端部的虚线延长(犹如将假肢外形假想延长)而且将点划线轴A也延长，直至三根线交叉(远离纸下端才可能出现交叉)。于是张开角α由两根虚线所夹。
此外在图2中还看到由颈部5轴线与假肢轴线A所夹的角度β。这个角度也被称作CCD角(椎体-颈-骨干角)。这个CCD角β在所示的假肢实施例中位于120°至150°之间，特别是位于大约135°。135°的CCD角经常在年轻患者股骨中出现，对于老年患者这个角度通常较小。但是这种CCD角的假肢完全也可以植入老年患者。这种CCD角假肢的植入可能对这样的患者产生部分肌肉韧带器官绷紧的现象，韧带器官通过较大的CCD角似乎又被“张紧”并被激活。
此外在图2中还可以看到不同的截面IV-IV，V-V，VI-VI，VII-VII，和VIII-VIII。这些截面本身在图4至8中画出。在图4中看到一个假肢1远端部分2的截面。截面是圆形的，这对于在图5中所示的远端部分2的V-V截面是同样的。但是这个截面直径大于IV-IV截面直径，因为假肢是从远侧端开始连续整体扩大的。图6所示截面VI-VI已经位于假肢的近端部分3上。在那里已经微微看到在假肢侧面向着腹部伸出的肋骨4。此外还看到，假肢在近端部分3整体的继续扩大。这一点尤其从图2中也可以看出。
在图7中可以看到沿图2中VII-VII线的截面，在此假肢1侧面上向着腹部伸出的肋骨4比VI-VI截面更明显地显露出来。最明显的向腹部伸出的肋骨4在图8中的沿图2的VIII-VIII截面中可以看到。
从图4至8可以全面看出，假肢1直接从远端部分2的最远端开始就整体锥形扩大，并且在近端部分3继续假肢的扩大。这种假肢造型的第一个优点是，不存在后切除，使得在粘合式固定时不存在空气夹杂，这种空气夹杂在后切除情况下是可能出现的，因为骨骼粘合剂在假肢插进粘合剂时只有微弱的流动性(即高粘滞度)，已经由假肢排挤的粘合剂的回流是几乎不可能的。这种假肢造型的另一个优点是，从远侧端开始整体锥形地假肢扩大在假肢远端部分2也可以使在非粘合式固定时假肢特别容易地插进股骨骨干区域上的骨髓腔里面，因为在股骨骨干区域上的骨髓腔同样是轻度锥形延伸构成的。反之对于非锥形圆柱形假肢远端部分可能会在假肢插进时出现卡住，使得外科医生必须得附加地对骨髓腔扩孔，以在非粘合式固定时起到所期望的近端固定的作用。但是这一点对于外科医生来说意味着在股骨解剖时附加工作步骤。在粘合式固定通过假肢远端部分2整体的锥形扩大起到对粘合剂压迫的作用并由此改善粘合剂在孔洞里海绵组织中的分布。
图3还接着给出了图1所示假肢1从侧面向中心看过去的视图。在这个视图中同样可以看到向腹部伸出的肋骨4。此外还可以看到，假肢在近端部分向前面倾斜。这个倾斜角度γ也常常被称为前倾角，其范围在5°至17°之间，特别是位于大约11°。这个范围包括最经常出现的前倾角值，这个大约11°的前倾角γ值对应于最经常遇到的角度值。
由于出现的股骨尺寸可能是完全不相同的，所以得建立全系列假肢以覆盖整个股骨尺寸系列。尽管在预定的手术计划中已经得到了一个完全确定的患者假肢尺寸，但是可能在手术中最终证明，或者更大一点的植入体或者更小一点的植入体也许更好一些。出于这个原因本发明的另一方面涉及不同尺寸假肢的系列，这种系列中的每个假肢由前面所述结构而构成。这种系列的假肢是按照所谓的“洋葱皮原则”而建立的，即两个相邻假肢尺寸的厚度值相差一个恒量。两个相邻尺寸的长度值同样差一个恒量，但是这个恒量可能又不同于厚度差的恒量。
尤其是在通过骨骼粘合剂固定中存在着不同的观点。这些观点主要是关于不同的粘合层厚度，这个粘合层是包围假肢的(即指股骨孔洞与假肢之间的粘合层的厚度)。有些观点得出很薄的粘合层，位于十分之几毫米范围，另一些观点得出粘合层厚度从大约1毫米直至3毫米。尤其是对于后一种粘合剂层范围，无论是粘合式固定还是非粘合式固定，假肢尺寸都是非常重要的。假如预定手术计划是非粘合式固定而在手术中被证实，应采用粘合式固定，则必须得选择一种从尺寸上明显较小的假肢。然而对于粘合式固定较小假肢颈部必须得与非粘合式固定假肢颈部具有基本相同的尺寸。因此本发明的另一方面涉及到一套假肢，这套假肢包括两个如前所述结构的假肢系列。在第一系列中假肢用于非粘合式固定，而在第二系列中假肢用于粘合式固定。在此对于非粘合式固定假肢(来自第一系列)也可以包含在相应的粘合式固定假肢(在第二系列中)，但是也可能是，例如对于两个相邻尺寸的非粘合式固定假肢只包含一个具有粘合式固定(在第二系列)中间尺寸的假肢。来自第二系列(粘合式固定假肢)的那个对应于第一系列非粘合式固定假肢的假肢小于相应的在第一系列中的假肢。但是第二系列(粘合式固定假肢)的假肢颈部对应于非粘合式固定的相应的假肢颈部的大体尺寸，对于粘合层的厚度还可能对此有一个在手术进行当中的决定，是应该采用非粘合式还是粘合式假肢固定。
不言而喻，对于非粘合式固定的假肢材料和粘合式固定的假肢材料是不同的。对于非粘合式固定的假肢首选采用钛合金是由于这种合金的生物兼容性(最终骨骼必须得长在假肢上)，对于粘合式固定的假肢考虑采用例如钴铬钼合金(CoCrMo-合金)。对于非粘合式固定和粘合式固定的假肢从柄型上来说还是完全相同的，因为假肢柄型对于两种固定形式都是适合的。

Claims (6)

1.假肢(1)包括基本上圆形截面的远端部分(2)，和与这个远端部分(2)连接的近端部分(3)，在近端部分的侧面具有一个向腹部伸出的肋骨(4)，此外假肢(1)上的近端部分(3)向上扩大并且在上端具有一颈部(5)，在颈部上可以安放关节头，其特征为，假肢(1)的直径从假肢(1)的远侧端开始基本上整体锥形扩大。
2.如权利要求1的假肢，其特征为，锥形扩大的远端部分部位上的张开角(α)在1°至10°范围内，特别是位于2°左右。
3.如权利要求1或2的假肢，其特征为，假肢纵轴线(A)与颈部轴线之间的角度(β)位于120°至150°之间，特别是位于135°左右。
4.如权利上述要求之一的假肢，其特征为，假肢(1)在近端部分(3)向前面倾斜。这个倾斜角度(γ)或前倾角位于在5°至17°之间，特别是位于大约11°。
5.不同尺寸假肢的系列，其中这个系列中的每个假肢(1)由前面权利要求所述的结构而构成并且不同尺寸的假肢是按照“洋葱皮原则”而构成的，两个相邻尺寸的厚度值相差一个恒量。
6.一套假肢，包括两个如权利要求5的假肢系列-第一和第二系列，在第一系列中假肢(1)用于非粘合式植入，而在第二系列中假肢(1)用于粘合式植入，其中来自第二系列的那个对应于第一系列非粘合式植入假肢的假肢小于相应的在第一系列中的假肢，但是第二系列的相应假肢(1)颈部(5)对应于第一系列的相应假肢(1)颈部(5)的大体尺寸。
CN99106979A 1998-06-04 1999-06-03 假肢 Pending CN1245675A (zh)

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