CN100337599C - 产生与组织部分且尤其是骨骼部分的连接的植入假体 - Google Patents
产生与组织部分且尤其是骨骼部分的连接的植入假体 Download PDFInfo
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- CN100337599C CN100337599C CNB028058879A CN02805887A CN100337599C CN 100337599 C CN100337599 C CN 100337599C CN B028058879 A CNB028058879 A CN B028058879A CN 02805887 A CN02805887 A CN 02805887A CN 100337599 C CN100337599 C CN 100337599C
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- implanting prosthetic
- implanting
- prosthetic
- resonator
- tissue
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- 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.)
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Abstract
为形成与人类或动物的组织部分且尤其是骨头的形状配合连接,使用植入假体(7),所述植入假体用于使该组织部分与另一组织部分连接或与一个代替或支承该另一组织部分的人造元件或辅助治疗装置连接,它至少部分由可借助机械能被液化的材料组成,特别适用的材料为热塑性(如可被吸收的热塑性塑料)或摇溶的材料。所述可液化材料按以下方式布置在该植入假体上,即它能接触到该组织部分并且能通过机械振动被激发并同时压在该组织部分上,从而使所述可液化材料的至少一部分液化并被压入该组织部分的开口内。为此,使植入假体接触该组织部分,在接受超声波能量作用的同时,使植入假体压在组织部分上。然后使可液化材料液化并压入组织部分的开口或表面粗糙处内,一旦凝固,它就直接连接到那。
Description
技术领域
本发明涉及植入假体,该植入假体用来产生与人类或动物的组织部分且尤其是骨骼部分的至少部分形状配合的连接,其中借助植入假体使组织部分彼此相连或将组织部分连接到支承或代替组织部分的人造装置或其它辅助治疗装置上。
背景技术
产生与骨骼部分(骨头)连接的已知植入假体是如螺钉、销、搭扣等,它们被用来使骨头相连或把骨头连接到人造的、承载的、稳定的支承部件上或连接到取代骨骼部分(稳定板或固定板、缝合线、金属丝、人造关节、人造牙齿等)的部件上。这种植入用连接件如由金属或塑料构成,也由可被吸收的塑料构成。在治愈后,或许又通过手术把它们取出来,但也可留在体内,在那里,它们可能逐渐分解并被活组织取代。
为了稳固骨折部,用上述螺钉把带有适当孔的固定板固定在断折区内。板和螺钉例如由金属(如不锈钢或钛)构成。所述螺钉为自攻螺钉并且被拧入骨头的无螺纹孔内,或被拧入预先钻好的螺纹孔内。为了相似目的,销和搭扣被敲入先前形成的孔内。通常,所获得的连接是摩擦接合的,或许也是形状配合的。
在所有情况下,在装入上述连接件时,需要用很大的力(扭力和打击力),取出时也是如此。这经常意味着,为了植入和或许取出,植入假体必须具有比其在装入状态下要承受负荷时更高的机械稳定性。尤其是在用机械强度明显低于金属的可被吸收塑料制成植入假体的情况下,这导致植入假体必须有较大的横截面,因此,对植入而言,也不希望地要在活组织中形成很大的开口。
连接件的机械安装也可能造成相当多的热量,所述热量损坏了周围的组织,在这种安装中必须克服产生摩擦接合的摩擦,尤其是在给没有预先钻孔的植入假体攻螺纹、拧入自攻螺钉和敲入时。
还知道了,为形成上述连接而在手术中使用了可硬化的塑料材料(如,基于水合或聚合物的特殊粘固粉),在粘性较高的情况下,这种材料从外面被压入植入假体与活组织之间或被压入组织缺损中并且当场硬化。只有当该材料被压入其中的孔具有适当的底切槽时,才能形成形状配合的连接。
发明内容
本发明的目的是提供用于产生与组织部分(尤其是骨头部分、软骨部分、腱部分、韧带部分或其它组织部分)的形状配合连接的植物、入假体,它可以用较小的力而简单快速地植入,该植入假体在植入后能够立即产生非常稳定的连接(初始稳定性)。此外,人们要求所述植入假体在热量和应力集中方面出现比至少某些已知的植入假体部件时更少的问题并且要求可以进一步减小待植入外来材料的体积。本发明的进一步目的是提供该植入假体的植入装置和方法。
为了实现上述目的,本发明提供一种产生与组织部分的形状配合连接的植入假体,以使该组织部分与另一组织部分连接或与一个代替或支承该另一组织部分的人造元件或辅助治疗装置连接,其特征在于,该植入假体至少部分由可通过机械能被液化的材料组成,所述可液化材料按以下方式布置在该植入假体上,即它能接触到该组织部分并且能通过机械振动被激发并同时压在该组织部分上,从而使所述可液化材料的至少一部分液化并被压入该组织部分的开口内。
本发明利用了已知的如出版物WO-98/42988所述的事实,即,尤其是热塑性聚合物可通过机械振动而有目的地被液化,在这种情况下,流体静压可以把热塑性聚合材料压入空洞(如木材孔)内,这在凝固后产生了形状配合连接。
根据本发明,用于产生与组织部分的形状配合连接的植入假体至少部分由可在低温(<250℃)下通过机械振动能量(尤其是超声波)即通过内部和/或外部的摩擦而液化的材料组成,该材料可在外部压力作用下被压入孔或组织的其它开口内,从而在重新凝固时形成形状配合连接。
可在低温下塑化的聚合物适用作本发明植入假体中的可通过机械能而液化的材料,尤其是已用于医学的已知热塑性塑料。这种不可被吸收的热塑性塑料例如是:聚乙烯(PE)、聚甲基丙烯酸甲酯(PMME)、聚碳酸酯(PC)、聚酰胺、聚酯、聚丙烯酸酯或相应的共聚物。这种可被吸收的热塑性塑料例如是:基于乳酸和/或乙醇酸(PLA、PLLA、PGA、PLGA等)的聚合物以及多羟基链烷酸酯(PHA)、聚已酸内酯(PCL)、多聚糖、聚二环己酮(PD)、聚酐或相应的共聚物。本身已知的具有摇溶特性的水合粘固粉或聚合物粘固粉也是适用的,例如磷酸钙粘固粉、硫酸钙粘固粉或异丁烯酸盐粘固粉。粘固粉也可以含有事先准备好的摇溶天然组织或异丁烯酸盐材料。由于其摇溶特性,通过施加机械能(尤其是超声波)并且在没有升温的情况下,粘固粉可以从比较粘糊的状态进入流动状态。
在植入时,本发明的植入假体(在表面上或在或许特意为植入假体开设的开口内)开始接触组织部分,然后施加超声波能量并同时将它压在该组织部分上。通过相应地形成植入假体并通过能量的适当测定,保证了只使需求量最少的可液化材料被局部明确地液化。只要液化并压入足够多的材料,就停止供应能量,从而液化材料凝固成新的形状,其中最好保持对该植入假体施压。
为了植入,不是通过外部热量,而是通过机械能(振动能、摇动能)而因内部和/或外部的摩擦来液化所述材料。因此,给周围组织造成的热负荷始终较低。通过机械能,在不同材料相之间获得强剪切效果。这有助于均匀液化以及获得不太粘的和仍然较低的周围负荷。然后,流体静压把以这种方式液化的材料压入周围组织的孔或开口内,在利用流体静压的情况下,可渗透到周围组织中并强化。
必要时,为了其它功能而有利地把附加物质混入液化材料中,如加入机械强化材料的物质,它在一第二反应中使该材料膨胀或在那里形成孔,可被释放到活体周围中以促进治愈或再生的物质,或可负责其它功能的物质。作为促进治愈和再生的物质,例如可以如此加入生长因子、抗生素或抗炎制剂,从而该物质随着材料流动可进入预期位置或有目的地分布到组织区内,并且在是可被吸收材料的情况下,该物质可以延期释放。
使用本发明的连接植入假体,可以实现多点连接或大表面连接。可以有目的地影响和控制连接负荷分配。例如,用本发明的植入假体,可以大表面(参见图15或16)或多点且深层次作用(参见图2-4)地把固定板或稳定板固定到骨头面上。如,通过板或其它有一体的液化区或完整的液化层的支承装置或固定装置,实现了面连接,为了与一骨头相连,所述液化区或液化层位于该骨头上且随后至少局部受到机械能(如超声波振动)的激发。可液化区有利地配备有能量方向传感器或与能量方向传感器接触。能量方向传感器可以是突出部件,它例如成棱锥形、圆锥形、半球形或肋状并且引起所施加的机械能的集中。
深度固定是如此实现的,即销状或木楔状植入假体被装到组织表面上或之内并随后被激发,该植入假体的横截面在其长度上是不变的或变化的并且该植入假体完全或部分由液化材料组成。植入假体被有利地设计成在预定位置(顶点或特定杆部)液化。在这里,通过能量定向发送器(以预定方式成形的突出件)也可以实现可控的液化。通过把植入假体装入待连接组织内,实现了深层次固定。液静压状况可以是这样的,即液态材料压在大压力下被压入邻近组织中。
用来植入本发明植入假体的装置,即用来液化与组织部分接触的可液化材料及把可液化材料压入组织中的装置,还可以适用于积极地控制在周围组织和材料中的温度分布,从而可以防止由此引起的不可容忍的热量和温度对活组织的损害。通过借助该装置的控制装置和或许适当安装的传感器和导热件来积极控制供给或输出的能量(热分布和热管理),可控制植入过程。就是说,通过计量输入能量并通过散发多余能量来控制植入。
材料液化所用能量最好由压电激励装置或限磁激励装置来产生。一由振荡器控制而产生振动的振动单元在约2kHz-200kHz并最好是超声波(如20kHz或40kHz)的频率范围内把波传给正与其有效连接(压住它)的植入假体。植入假体被连接到待连接的骨头或组织上,从而声能导致可液化材料的内吸收能量或表面吸收能量,这样,材料至少局部液化。通过强剪切效果实现了液化。通过具有不同密度且局部被包在待液化材料(如小球)内的第二成分,可以增强内摩擦并由此增强内部液化。在以特殊的摇溶粘固粉为植入假体或植入假体部件时,情况就是这样。
通过本发明方法而产生的连接主要是形状配合连接,其中该形状配合接头在两侧可能非常小(表面不平整、表面粗糙或组织孔)或较大(在组织或组织部之间的大空隙,或受力形成的开口或组织中的空洞)。如此借助超声波来机械激发连接植入假体,即尤其是在与组织部分接触的区域内或连接植入假体的内部,可控地液化它们。液化通常发生在组织表面或组织内的适当开口中,该开口是因连接植入假体渗过组织表面地进入组织或事先用其它机械装置而形成的。
非常简化并示意地描述了在可液化材料的深度装入该组织时的要观察的效果是,与在液压缸中的活塞类似,连接植入假体的还未液化的材料位于一组织开口内并且基本上密封地充满开口。因为该液化材料不能从开口排出,所以外界作用的负荷产生了液静压(施加于植入假体的压力)。由于该压力和振动,液化材料被压入周围的待连接材料(活组织)的已有和/或新近形成的空洞内。该渗透深度尤其取决于这些围绕物的性质、取决于手术参数并且取决于可液化材料(尤其是其粘度)。通过该连接植入假体的可液化或液化体积,可以确定压入该组织中的材料量。如果需要大量液化材料或者不知道组织内出现的空洞尺寸和数量,则可以使用可以类似无限供给的植入假体或植入假体成分。
因灌入和压缩材料产生的并可导致失效如组织破损的应力峰值通过明确的并相互协调地施加超声波和机械压力或流体静压并且通过植入假体及设置于其上的可液化材料的适当设计来避免。在非常多孔的并或许无预钻孔的组织中,空洞和缝隙被可液化材料填满。通过在相邻组织区中的可液化材料的受控压缩而实现了,即便是非常多孔的组织(如骨质疏松的骨组织),连接植入假体也牢固滞留其中。这样,本发明植入假体可以经受强大的机械拉出力或负荷,这在治疗稍后阶段在使用至少部分可被吸收的材料的情况下被可控制地降低,或通过再生组织来承受(第二稳定作用)。
本发明适用于如在颚内固定假牙。假牙最好包括一成本发明植入假体形式的标准根部并能够与各种牙冠相连。根部完全或部分由可通过机械能被液化的材料组成,在位于颚骨内的一开口中时,该材料受机械能激发而液化并被压入骨组织孔内。因此,植入假体本身穿过开口和组织孔并且在,由此一来,出现了在齿根开口和在邻接骨组织里的马上稳定(初始稳定)的牙冠固定基础,它或许随后至少部分地被再生的骨组织代替。
在此公开的本发明的另一应用领域是如人造关节领域。人造关节窝及关节球或关节干可以与活骨组织相连或通过本发明植入假体被固定在那。除了在植入时小心输入力外,如此选择参与材料,即很大程度上避免刚性突增,这肯定有助于该植入假体的使用寿命。
用于植入本发明植入假体的装置如下所述,一振荡器用来产生待经传送装置如电缆传给一振动单元的电振荡。该振动单元包括一振动元件(驱动单元)和一谐振器,它们彼此有效连接。驱动单元(如压电元件)促使谐振器振动。谐振器的振动被直接或通过传送装置被传给植入假体。由于振动,通过内部液化反应或与非振动环境(组织部分或另一植入假体部分)的接触,至少局部液化植入假体。在激发期间内,可用适当的保持机构保持植入假体和/或通过一导向件引导该植入假体。对于最小侵害的手术,特别适合直接把植入假体固定到振动单元上。配备保持机构和/或导向机构不仅用于临时保持或固定植入假体,而且用于温控(尤其是热消散)。
由于有目的地局部液化植入假体材料,所以没有产生大量的热。另外,通过温控,有效地控制了与植入假体邻接的温度,如借助有目的地起到散热作用的导热件,或者用起到温控作用的液体(如林格氏消毒溶液)。
如在人类或动物骨骼上实现植入本发明植入假体的方法如下:植入假体与骨骼部分接触,然后产生机械振动并传送给植入假体的可液化材料,同时,植入假体压在骨骼部分上。供应机械能,直到可液化材料充分液化并在接触区内渗入骨组织或至少该骨骼部分的表面不平整之处内为止。然后,停止机械振动以使液化的材料再次凝固,在此期间内,最好保持流体静压。再次凝固的材料形状配合地把植入假体固定在该骨骼部分内。
如本发明所述的连接植入假体具有销、榫楔和/或板或薄膜形状。这些植入假体适于使组织部分彼此连接或使组织部分连接到人造元件上。
对上述方式的植入较为有利的是,使用一个包括至少一种本发明植入假体的全套工具或成组器械,有利地选择适合应用领域的不同尺寸的植入假体以及实现该植入的装置。所述全套工具或成组器械也包括用于装置消毒的装置(用于装置的消毒覆盖物)和或许部件的可消毒的更换件(尤其是谐振器、远端谐振器部件或传送部件)。通过不同形状,谐振器部件如适应于不同的植入假体和/或应用。此外,所述全套工具有利地包括用于植入的使用说明、特种植入假体的植入参数说明和其它准备组织部分(如匹配植入假体的钻孔)的辅助机构、定位仪器、控制装置和/或适应于植入假体和/或谐振器的植入假体导向装置。
最好通过植入假体的补充使全套工具或成组器械总是做好使用准备。这种选择是根据要求来定的并可以随时间变化。这种补充品(代用配套工具和附加配套工具)一方面包括所用植入假体的代用品和新型植入假体,它又例如带有用于组织制备的适当装置、定位仪器、控制装置、适合的谐振器或谐振器部件、植入假体导向装置和尤其是相应的植入说明书。
附图说明
经随后的附图更详细地说明本发明,其中:
图1表示本发明植入假体的植入装置的一示范实施例及其使用;
图2表示通过本发明植入假体被固定到骨头上的固定板;
图3、4表示要用于如图2所示应用中的本发明植入假体的实例和由此在骨头和板之间的产生的连接;
图5a-5e表示本发明销状植入假体的示范横截面,该植入假体包括轴向延伸的能量定向发送器;
图6-8表示本发明的两个销状植入假体实例的纵截面,该植入假体包括不可液化材料的植入假体部分;
图9-13表示在销状或榫楔状植入假体和谐振器上的配合保持机构的示范实施例;
图14表示本发明的植入假体用在人类颅骨和颚骨上;
图15-17表示用于颅骨区的本发明植入假体和由此在两个颅骨部分之间产生的连接的例子;
图18表示用于如图16、17所示应用的示范谐振器装置;
图19表示本发明植入假体进一步用在人体脊柱区;
图20表示本发明植入假体进一步被用来固定假牙;
图21、22以截面图示出用于如图20所示应用的两个本发明植入假体的例子;
图23表示通过本发明植入假体被固定到前臂上的固定装置;
图24表示适于如图23所示应用的连接植入假体的实例;
图25表示通过如图24所示的植入假体被固定到骨头上的如图23所示的固定装置;
图26表示适于图23所示应用的连接植入假体的另一例子;
图27表示借助本发明植入假体被固定的并用于固定折断关节颈的转子板;
图28表示用于人造关节球的干,它利用本发明植入假体被固在管状骨上;
图29表示通过本发明植入假体被固定到骨头上的关节韧带;
图30表示例如由肿瘤造成的并用本发明植入假体填充并充满的组织空洞。
具体实施方式
图1简单示意性地示出用来植入本发明植入假体的植入装置1的一示范实施例。
装置1包括一振荡器2和一振动单元3,它们经一电缆4相连。部分容纳在一外壳5内的振动单元3被设计成如手钻般使用的手持装置。振动单元3包括集成在外壳5(未详细示出)内且与一谐振器(超声波电极)6相连的一振动元件。至少一远端谐振器部件突出到外壳5外。振荡器2给振动元件供应能量。受振动元件激发,该谐振器以预定频率振动,或者可能按预定频率图形振动。2Hz-200Hz的频率和双箭头所示方向的1μm-100μm的谐振器振幅是特别合适的。可以根据用途、待液化材料及谐振器和植入假体的形状来调整频率。也可以将超声波范围的振动与附加机械振动叠加,如低频大振幅的机械振动。但在多数情况下,该装置被设计用于单一振动频率如20kHz-40kHz和例如用于在z向(通过谐振器6将植入假体压住一组织部分的方向)上的谐振器振幅20μm-30μm,这就足够了。为了控制功率(单位时间所供应能量),激发可以是脉冲式的,在此可以调整脉冲间距和/或脉冲长度。
该振动频率和谐振器形状有利且本身已知地相互协调,从而该谐振器以驻波形式振动并且压住植入假体的其远端在z向上有最大振幅。进一步有利地赋予销状植入假体这样的长度,即该长度与预定的激发频率和预定的植入假体材料相匹配。
谐振器6的远端可以被设计用来保持一植入假体7,如图1所示。这简化了该植入假体在一组织部分上或在一组织部分的开口内如腿骨10上的定位。为了定位和没有开口的植入,也可以有利地设置一植入假体导向装置,该导向装置支承在外壳5或组织部分上。也可以把谐振器设计成有如同锤子的一平端面并且简单地使它压住一保持在一组织开口内的或通过适当的单独保持机构或导向装置被保持的一植入假体。这样一个谐振器的远端在植入期间内必须不粘住该植入假体。这是通过该谐振器适当的非粘附性端面或通过与谐振器相邻的并由不可液化材料组成的植入假体部分实现的。
为了可以用于消毒操作区,该装置如被用在消毒覆盖物中。该消毒覆盖物有利地包括用于该谐振器远端部分的一开口,并且该谐振器或一远端谐振器部分可以被拆下,以更换和消毒。
例如,本发明的植入装置1的其它示范实施例被设计成包括所有部件(包括能量供应)的手持装置或被设计成完全固定的装置。
图2表示通过本发明植入假体7被固定到如骨折或骨裂区的骨头部分上以稳定折断或开裂的固定板或稳定板21。在这种情况下,骨头部分20包括一较薄但较致密的外皮层骨质22,皮层骨质的下面是多孔的松质骨组织23。不同于图2所示,在天然组织中,该皮层骨质至松质骨的转变是其中组织变得越来越多孔的逐渐转变。植入假体7伸过该板21内的开口并穿过皮层骨质22地伸入松质骨23内,它们至少被固定到该松质骨23内。
图3、4局部放大地示出了本发明植入假体的两个例子,它们例如可以用于如图2所示的应用中。图3表示植入后的一植入假体,图4表示一在板21的一开口和皮层骨质22内的以便施加振动能的植入假体。
为了植入,至少例如通过钻孔来打开皮层骨质。一适当的孔也可以以盲孔形式延伸到松质骨23内。因为骨头的皮质没有适当用来压入液化材料的孔,所以如通过攻制螺纹25或经粗糙化孔的内壁,可以产生这种开口或表面不平整。然后,可液化材料被压入该开口内并再次凝固而形成形状配合连接。植入假体的液化材料被压入松质骨23的孔内并且以这种方式深深地固定到该植入假体7内。如图所示,对组织而言,液静压把一流体材料压入该组织孔内要比机械导入一固体材料要温和得多。为此,可以产生与没有不太坚硬的组织如骨质疏松的骨组织的稳定连接。
为了把植入假体7连接到板21上,该植入假体可以包括一如同机械螺钉的头,如图2所示。如图3所示,金属板21内的开口也包括一如同骨皮层骨质22中所产生的螺纹的内螺纹,该液化材料穿透并且凝固在该螺纹中,形成形状配合。在这种情况下,可省掉一头。植入假体7不是通过突出植入假体部分的不理想切头而是通过使尺寸适当的植入假体移动到理想位置上而与该板21对齐。
对由热塑塑料制成的板21来说,板与植入假体之间的连接(耐抗松动性)可以如图4所示地通过材料融合连接和固定在组织中(焊接或粘附)来实现。在移动植入假体时已开始地在连节点26处形成材料融合连接。同样在这种情况下,有利地移动该植入假体7,直到它最后与该板21的外侧齐平。
因为该植入假体7不需要被拧入该组织内,所以不需要设计包括用于在较大扭力下连接情况确实如此的已知螺钉的装置。因此,所述植入假体的尺寸选定可以仅仅针对其在植入情况下的功能,即所述植入假体更细长并在组织中待产生的开口比使用同样材料的传统螺钉的情况要小。因为经材料的液化和凝固形成了形状配合,它包括较小的应力和切口,所以进一步提高强度并使得它不容易材料疲劳失效。
要深深地固定到组织部分内的本发明植入假体如图2-4所示地有利地成销状或榫楔状,并且如其远端及另外的表面区包括可液化材料,在所述表面区需要固定(如,在板21内一螺纹和骨皮质22内)。为此,如图2-4所示,它们可以完全由可液化材料组成,其中材料待液化的远端和表面区尤其有利地配备有能量定向发送器,或能量定向发送器被设置在开始接触这些区的表面上。这种能量定向发送器例如是植物假体远端,它成尖头形状或以其它方式渐缩成一个或多个点状或线形尖头区。另外,待液化的表面区包括如其高度和宽度都要适应于待产生的固定部的隆起、顶点或肋。所述能量定向发送器至少比该表面突出10μm。它们也可以较大并且例如以轴向伸展肋的形式导致隆起状或有棱角的销横截面,如图5a-5e的示范形式所示。销状植入假体的整个或部分长度具有这种横截面。
对于除了固定到远端区内外的或者作为在其外周面区域里的唯一固定点的销状植入假体,设有组织开口(如孔),所述开口在插入植入假体时在至少一些位置上导致在组织和植入假体或能量定向发送器之间的摩擦配合,所述开口比所述植入假体的横截面的略窄。
对于其它功能,可液化材料可以含有外来相或其它物质。尤其是,经混合纤维或晶须(如,磷酸钙陶瓷或玻璃)来机械加强该材料。可液化材料可以进一步包括现场可膨胀或溶解的并由此形成孔的要素(如聚酯、多糖、水凝胶、磷酸钠)和现场待释放的以抗击酸分解负面作用的物质如生长因子、抗生素、抗炎制剂或缓冲剂(如磷酸钙)。也可能是用来促进x射线照片中的可视性或类似功能的混合物。
事实表明,用来固定到松质骨内的根据图2-4的植入假体由聚合物如PC或PLLA组成且具有3mm-4mm的直径,该植入假体有利地在用于压入的植入假体横截面区域内施加0.5-5N/mm2的压力。指定范围内的力造成了大于5mm/s的敲进速度。
图6-8表示另外三个销状植入假体7的例子,它们除了由可液化材料构成的区域外还有一由不可液化材料如金属、陶瓷或玻璃或合成材料构成的芯11(图6和7)或套13(图8)。
根据图6、7的植入假体的远端包括一可液化材料的帽12,它或多或少地被弄尖(图6)或包括许多收缩成尖头或直线的端部(图7)。芯11的外周面完全(图6)或只是局部地被可液化材料包围住,其中包围区域是轴向延伸的,或呈环形或可以规则或不规则地分布在该外周面上。这些区域有利地包括如上所述的用于完全由可液化材料组成的植入假体的能量定向发送器。可液化材料的厚薄取决于所需的渗透深度,但不应薄于约10μm。
如图6所示,阶梯状横截面缩小适用作能量定向发送器。有相应阶梯面的植入假体被植入相应成阶梯状的或缩窄的组织开口内。
有不可液化的芯11的销状或榫楔状植入假体的能量施加可能涉及植入假体的整个近端或只涉及由同样可液化材料组成的环形外部区。
根据图8的植入假体在一不可液化的套13的内部有可液化材料。套13配备有开设于需要固定的位置上的开口。本发明植入假体的这个实施例尤其适用于以高粘性摇溶材料为可液化材料,因为该材料经受不住由于谐振器压在植入假体上所造成的机械负荷。确定该套内的开口的尺寸,以使高粘性材料只能在液化时通过。多孔烧结材料构成的套13特别适用。带套13的植入假体要定位在一组织开口内并且该谐振器只被用到可液化材料上,即具有适合该套内部横截面的横截面。
在销状或榫楔状植入假体的近端上,可设有如一用来代替或固定其它组织部分的加厚头状人造部分、一辅助治疗装置、该装置的固定装置或一缝合线或环扎线的固定装置。在销形或榫楔状植入假体的近端上,也可以设置一与在谐振器上的对应保持机构配合的保持机构(见图9-11)。
在销状或榫楔状植入假体内的一个金属芯11通常用作植入假体的机械加固件并为此有适当的尺寸。但该芯也可以较薄并易于从该植入假体中取出。在这种情况下,它例如作为用于最小侵入的x射线照片的可视结构或作为导向丝在植入后被马上取出。
带有如金属芯的、被固定到组织内的并包括可被吸收的液化材料的本发明植入假体在植入后立即具有良好的初始稳定性。当该固定材料分解时,该固定松动,有植入假体产生的稳定变成动态,从而组织本身要承受越来越多的负荷,这促进了自然的再生过程并在许多情况下防止萎缩。在可液化材料分解后,如果芯表面被设计成不使活组织与它长在一起,则可以容易地移去芯。但如果芯表面促进组织的内部生长(生物活性表面),则内部生长构成了固定在该组织内的植入假体或植入假体芯的理想的第二稳定性(同样参见图28)。
图6、7所示的植入假体芯不仅可以由金属(如钢、钛或钴铬合金)构成,也可根据用途由塑料(如聚醚芳基酮、聚氟乙烯和/或聚氯乙烯、聚醚酰亚胺、聚醚砜、聚乙烯氯化物、聚亚安酯、聚砜、聚酯)或陶瓷或玻璃状材料(如氧化铝、氧化锌、硅酸盐、磷酸钙陶瓷或玻璃)或合成材料(如碳纤维强化型高温热塑塑料)组成。
图9-13显示出在植入装置1(图1)的谐振器6(超声波电极)的远端部分之内或之上保持本发明的销状或榫楔状植入假体的不同应用例。保持机构可以是如图9、10所示的形状配合保持机构。该形状配合例如这样实现,即可在谐振器6远端上插入一相应开口15内卡在那里的植入假体7或一植入假体芯11的一弹性的近侧延长部14的快速接合(图9)。该形状配合也可以借助伸过该谐振器6和一植入假体芯11或植入假体近端延长部14并适当固定的销16来实现。在这里,为此有利地考虑到该形状配合结构与谐振器远端有一段距离d,在该距离处,为了在z向上振动而有一节点,就是说,z向的振幅基本为零。
图11表示借助螺丝17的在谐振器6与植入假体7之间的传力配合连接。如果如此拧紧该螺丝,即振动不中断地传过界面,则植入假体7变成谐振器6的一部分并进行相应设计。这表示该谐振器的远端在z向上不必需要最大的振幅,在这里,例如也可以有一节点。
图12、13表示在谐振器6上保持其近端由可液化材料组成的植入假体的有利的植入假体保持机构。在这两种情况下,涉及到植入假体近端的由超声波作用决定地成形并粘接在谐振器远端上,它通过在谐振器6上的适当的能量定向发送器被启动。图12表示有一远端面的谐振器6,该远端面象碎石锤打击面样地形成。图13表示有一中心能量定向发送器的谐振器6。在这两种情况下,谐振器6的能量定向发送器接触该植入假体7的近端并使谐振器开始振动。在谐振器的能量定向发送器区内的可液化材料先液化并与谐振器粘接,其中它具有谐振器远端面的形状并在图12所示的情况下形成一头部18。
在把植入假体定位到组织部分之上或之内以前,如图9-13所示地有利地把该植入假体保持到该谐振器上,在图12、13的情况下,在植入后,施力来解除这种保持,结果,谐振器脱离如弯离或转离该植入假体7。
图14表示本发明植入假体的另一应用领域,即固定一插入颅顶39开口内的骨质盖板30或由人造材料构成的盖板和把一个如人造固定板31固定在一骨折或骨裂的颚骨32上。类似用途可以是面部再造手术。在盖板30与周围骨组织之间待产生的连接被有利地限制在该板与天然骨头之间选定缝隙位置33上。固定板31同样在所选板位置31’上与颚骨相连。借助植入装置1,通过连续植入步骤形成所选位置上的连接。
图15-17局部放大地表示可用本发明植入假体产生的且适用于图14所示用途的连接。
图15表示本发明的一植入假体,为了在颅骨29和待装到颅骨开口内的盖板30之间的至少局部连接,其中该盖板例如由多孔材料(如也是颅骨)构成,该植入假体位置靠上并借助通过超声波能量(双箭头)被植入,以跨过缝隙33(下方)地连接颅骨29和盖板30。
有利地倾斜形成缝隙33,以便由颅顶29来承受施加到该缝隙区的外来压力,为了定位该植入假体7,该缝隙延伸到外面。如成球形或香肠状的并由热塑塑料或摇溶材料构成的植入假体位于外缝隙扩宽区内并接受振动能量。因此,植入假体材料被液化并在一侧被压入颅顶29的孔内,而在另一侧被压入由如骨头组成的盖板30的相应孔内,或压入相应布置在人造板内的人造开口(如虚线所示槽)内。于是,在颅顶29和盖板30之间出现了在两侧形状配合地被固定的连接。
图16表示一固定薄膜35,它也可以具有织物表面结构并可以用于将盖板30局部固定在颅顶29开口内。薄膜35例如成带状并有利地易弯曲。它完全由可液化的热塑性塑料构成或如用纤维垫或类似结构来强化。它跨接缝隙33并在两侧(双箭头)借助植入装置(图1)被激发,从而使它粘到颅顶29或盖板30的表面(大面积的较浅的连接,该连接也可以被限制在多个或成图案的独立固定点)。或许,植入假体要与在其下面的材料连接的表面区可以适当地被预处理(如变粗糙)或在人造板30上设置适当的表面结构(表面不平整、凹槽、槽等)。为把薄膜35接到骨面上,谐振器端面的0.5N/mm2-3N/mm2的压力就够用了。
图17表示一固定板36,它在一固定薄膜35或相应的织物表面结构的帮助下被固定到缝隙33上,它为了承受相当大的力而如由金属构成,因此除用于颅骨外,它还可以被用在也如图13所示的颚骨或如图2的应用中。固定板36由这样的材料构成,即它在本发明意义上均不可液化并且在它指向待固定组织的表面上有一适于形状配合的表面结构。薄膜35位于板36与待固定组织或材料之间并对板36的至少局部施加振动能量并由此被接到该颅顶29的表面和盖板30上。在植入期间内,可以在薄膜35与固定板36之间产生形状配合连接,或已经通过薄膜35被连接到那的板36可被用作完成的植入假体。在这种双层植入假体中,层间连接也可以是材料融合形式的(粘接或焊接)。在这种双层植入假体内,薄膜35也可以被限制为该板的涂层,该涂层有利地没有不变的厚度,而是在能量定向发送器意义上地由隆起、尖头或肋的图案构成,其最小高度约为10μm。
图14所示的固定板31包括如布置在适当凹处内的薄膜区31’并且有一配备有能量定向发送器的外表面。这些薄膜区与位于其下的颚骨区相连。
尤其对于图16所示的应用,如此设计谐振器是有利的,即传给植入假体的振动没有如双箭头所示地垂直于待产生的连接面(z向),而是与之平行(x/y方向)。或许,如图18所示的传送件37较为合适。传送件37与谐振器6传力配合连接,确切地说在一个波在z向上有一节点(振幅=0)并因而在x/y方向上有最大振幅的位置上。x/y方向上的振动被传送件37传给薄膜35。
图19非常简单示意地示出了作为本发明植入假体的另一用途的用于人类脊柱区的支承件。支承件40是弹性的且永久或可能临时地支承着脊柱区。在本发明的意义上,支承件40被固定到脊柱上,即它由可相应液化的材料构成并没有深深地固定住(如图16所示),它由不可液化材料组成并通过薄膜而没有深度地连接到脊柱上(如图17所示),或利用预设孔而深层次地连接到脊柱上(与图2-4相似)。图19所示的销状植入假体具有突出到支承件外的头部并且是按照图12制成的。对永久支承而言,连接植入假体和支承件由不可被吸收材料制成,对临时制成而言,由可被吸收材料制成。
图20表示本发明的榫楔状植入假体7在颚骨32内形成一人造牙齿40基底的应用。植入假体7至少部分由热塑性塑料或摇溶材料构成。它在端面上有固定人造牙齿40、齿桥或假牙的保持机构。植入假体在有或没有人造牙齿的情况下安置在相应开口内并在超声波振动下被进一步压入。因为同时使植入假体的至少一部分液化,所以它不仅在很大程度上没有缝隙地填补了植入假体与骨头之间的缝隙,而且它被压入颚骨孔内,所以如图21的截面图所示地出现深层连接。
图22以截面图表示本发明植入假体的另一示范实施例。此植入假体尤其适用于图20所示用途。可液化材料没有布置在植入假体外表面上,而是在一允许在液态下的可液化材料渗透的套13内,如结合图8中所描述的那样。沿剖面线所示,在中线的左侧是未使用超声波前的植入假体,在中线的右侧是使用超声波后的植入假体。套13例如由金属或陶瓷的多孔烧结材料构成并承担植入假体的支承功能。在所示例子中,套13有一开口,该开口例如有内螺纹并可被固定在人造牙齿、齿桥或假牙中。植入假体有另一个环形开口43,可液化材料如由可液化材料构成的圆柱形件44定位于该开口里。为了目的明确的液化,能量定向发送器45设置在与可液化材料接触的环形开口43内。
图22所示的植入假体位于如一颚骨(41,图20)的开口内,然后,使用有一环形远端的谐振器6对可液化材料施加机械能。这样,该材料被液化并被穿过多孔套材地被压入周围骨组织内,由此一来,该植入假体被固定在此组织内。
对图19-20所示用途特别有利的是,可被吸收材料被选用作可液化材料,同时支承件由既不可液化也不可被吸收的材料构成,并且机械强度足以固定牙齿、齿桥或假牙。同时,至少中心部分的表面具有生物活性(如象套13那样描述地多孔),也就是说,配备生物活性以使它促进与骨组织的共生。在植入后不久,这种植入假体就具有足以固定牙齿、齿桥或假牙以及正常使用的初始稳定性。然后,经中心植入假体部分的生物活性表面促进的再生组织继续代替可被吸收材料并且与该中心植入假体部分长在一起。因此,本发明的植入假体没有用粘固粉就提供了直接的初始稳定性,并且在再吸收和再生阶段后提供了与已知植入假体的稳定性相等的第二稳定性。但与已知的植入方法相比,不存在过渡阶段,根据现有技术,在该过渡阶段里,开口41是闭合的且在牙齿、齿桥或假牙被直接固定到再生骨头内之前,要等待骨组织的再生。
图23表示一包括支承件52和一固定在支承件52上的支架53的外部固定装置51,该装置如借助本发明的植入假体被固定在人体手臂的管状骨50上。支承件52被设计成本发明的植入假体的形式。一管状骨的中间部分主要由皮层骨质组成并且只包括非常小的本发明意义上的多孔组织区。为此,如在图24、25中更详细示出的那样,管状骨50内的骨髓腔54被用于待压入的可液化材料。所述支承件例如配备有底板55,因为骨髓不足以对流体静压施加足够的阻力。
为固定该固定装置,在管状骨50中钻设(或有螺纹25)开口,直达骨髓腔54,其中,孔径分别等于植入假体7或底板55的直径。植入假体7包括一中心支承件52,底板55被固定到植入假体远端上并且可液化材料的一环形或管状区57被布置在支承件周围并基本上覆盖底板55。把植入假体引入开口56内并且通过适用的外用装置被保持在预定深度下。然后,支承件52周围的可液化材料57在超声波作用下压住底板55,所以在管状骨50与底板55之间被压入骨髓腔54内,从而形成了在开口56内保持支承件52的形状配合连接。该固定实现了支承件52的单皮层骨的防倾斜固定。根据现有技术,这只能通过一双皮层骨的固定才能实现。
图26表示本发明植入假体的另一实施例,该植入假体尤其适用于图23所示用途。如为摇溶粘固粉的可液化材料设置在支承件52内,有这样的尺寸的开口58设置在底板55之上,即有较高粘性的粘固粉不能流出,但由于谐振器6的作用而处于液化状态的粘固粉可以流出。支承件52的末端被设计成图8的套意义上的套。在谐振器的帮助下,穿过开口58的粘固粉将支承件固定在骨髓腔内和或许在邻近的骨组织内。
图27作为本发明植入假体地示出拉紧螺钉60,如它与一转子板61一起使用以固定折断的股骨颈椎骨。该拉紧螺钉60(在一植入假体套13的意义上,图8)是空心的且至少在远端有开口,一可液化材料可以通过开口被压出,以便能比只使用螺钉螺纹时更好地将远端区固定在如骨质疏松的组织区里。因此,螺钉螺纹尤其用于把骨折区内的组织拉合在一起,直到可液化材料把远端螺钉固定到该组织内为止。
图28表示通过本发明植入假体7把一人造关节件62固定到其上的管状骨50的截面示意图。关节件62的干63和布置在干周围的可液化材料57代表本发明的植入假体,它在超声波作用下被压入管状骨50内,该材料57被液化并被压入松质骨23的孔内和管状骨的皮层骨质22的表面不平整处。该干63在如图17所示的板36的意义上具有一个适用于与可液化材料57形状配合连接的表面结构。
如由钛构成的干63的一个特别有利的实施例包括一个多孔的并因而是生物活性的表面,该表面被可被吸收的液化材料包围。该植入假体在植入后直接具有允许至少承受部分负荷的初始稳定性。稍后,由第二稳定性接替该初始稳定性,第二稳定性由活骨组织与钛干63的多孔表面共生而决定的。这表示,人造关节件在植入后基本上可以不使用粘固粉地立即承受负荷。这种早期负荷促使活组织再生并且防止萎缩(骨质疏松症)。尽管如此,活组织在另一阶段内与钛干共生。
图29同样非常示意性地表示在韧带71连接骨头72和73的区域内的关节70。韧带71天然地与骨头共生,其中在过高负荷下,该连接可能撕裂。本发明的植入假体可被用来修复,其中可以使用根据图2-4的植入假体的实施例。为了修复,该关节骨头的皮层骨质被打开并且使销状植入假体7穿过韧带71并从外面用一头部(如根据图13)固定住。也可以想到根据图16和17的深度略浅的实施例。
最后,图30表示要通过本发明植入假体7形成的连接不一定被用于两个元件(两个组织部分或一组织部分和一人造部分)的连接。也可以将本发明植入假体用来填充由如一肿瘤造成的组织开口80。为此,有利地使用高粘度的植入假体7和摇溶材料81。借助一位于开口周围的导向装置82,此材料被导入开口18内并突出到开口外。用于此应用的谐振器6具有对应于导向装置82的内部横截面的横截面并且把材料81像活塞一样地压入开口80内。因此,不仅基本上无缝隙地填充了该开口80,而且在超声波作用下变成液体的材料81也被压入通入开口80的组织孔内,并且在凝固后形成形状配合连接,如图30下方所示。这种形状配合连接牢牢地把植入假体7保持在开口80内,甚至是在开口没有底切槽的情况下以及在没有设置其它保持机构(如在该植入假体上缝合的骨膜)的情况下。
经过适当精细加工的病人的骨材料可被混到可液化材料里。
在如图30所示的情况下,如果用热塑性材料来代替摇溶的粘固粉,则也可以特别制造开口80以接纳用于线84和缝合的固定件,如图30中(仅仅下方)虚线所示。可以以同样的方式来固定一辅助治疗装置如激励器。
例1
由PLLA和聚碳酸酯注塑而成的销具有直径为3.5mm-4.25mm的圆形横截面、26mm-40mm的长度(20kHz下的理想长度:35mm)、圆头逐渐缩小的远端和四个自远端起轴向延伸了10mm的槽,用20kHz的激励频率把销固定到新近屠杀的家畜的松质骨内(股骨头部)。为了植入,打开位于松质骨之上的薄的皮层骨质,但没有在松质骨上预先钻孔。在植入时,用60N-130N的压力使所述植入假体压住组织并且用激励频率(超声波电极振幅约为20μm-25μm)进行激发。前进速度被限制在2s内前进不到10mm。然后,无激发地保持植入假体达5s。
产生的固定深度达15mm,它在抽出时要强于植入假体本身(最大抽出力超过500N)。传感器被放在距离皮层骨质的预钻孔1mm处(骨表面下方1.5mm),在植入后约10s的温度据测为最高44℃(约高于室温22℃)。该过高温度在约30s内降低一半。
与尚未植入的植入假体的材料相比,对植入材料的PLLA材料来说,没有发现分子重量减轻。
Claims (35)
1、产生与组织部分的形状配合连接的植入假体(7),用于使该组织部分与另一组织部分连接或与一个代替或支承该另一组织部分的人造元件或辅助治疗装置连接,其特征在于,该植入假体(7)至少部分由可通过机械能被液化的材料组成,所述可液化材料按以下方式布置在该植入假体(7)上,即它能接触到该组织部分并且能通过机械振动被激发并同时压在该组织部分上,从而使所述可液化材料的至少一部分液化并被压入该组织部分的开口内。
2、如权利要求1所述的植入假体,其特征在于,所述可液化材料是热塑性或摇溶的。
3、如权利要求1或2所述的植入假体,其特征在于,所述可液化材料具有至少一种可被吸收的成分。
4、如权利要求1所述的植入假体,其特征在于,所述可液化材料还含有添加物质,该添加物质适于机械强化该可液化材料或者适于被释放入该植入假体的活体周围中以促进治愈或再生。
5、如权利要求1或2所述的植入假体,其特征在于,所述植入假体成销形或榫楔状。
6、如权利要求5所述的植入假体,其特征在于,所述可液化材料布置在该植入假体的远端的植入假体表面上和/或植入假体外周面上,该植入假体包括由不可液化材料构成的芯(11)。
7、如权利要求5所述的植入假体,其特征在于,该植入假体包括由不可液化材料构成的套(13),所述可液化材料被布置在该套内并且该套包括用于让已经液化的该可液化材料流出的开口(58)。
8、如权利要求6或7所述的植入假体,其特征在于,所述可液化材料是可被吸收的,所述芯(11)或所述套(13)至少局部地具有一个生物活性表面。
9、如权利要求4所述的植入假体,其特征在于,该植入假体在其近端有保持机构(14,15)。
10、如权利要求1所述的植入假体,其特征在于,该植入假体成板(35,36)的形状或成薄膜(35)的形状。
11、如权利要求10所述的植入假体,其特征在于,所述板或薄膜(35)是单层的。
12、如权利要求10所述的植入假体,其特征在于,所述板或薄膜(35,36)包括一层可液化材料和一层不可液化材料,所述可液化材料覆盖所述不可液化材料的表面的至少一部分,这两个层形状配合地或材料融合地彼此接合。
13、如权利要求1所述的植入假体,其特征在于,该植入假体是一个用于人造支承件或固定件、人造关节件、人造牙齿、齿桥或假牙、缝合线、环扎线或辅助治疗装置的固定装置。
14、如权利要求1所述的植入假体,其特征在于,所述植入假体被固定在一个植入装置(1)的谐振器(6)上,所述植入装置还包括振荡器(2)和振动元件,该振荡器(2)设置用来激发该振动元件产生机械振动,该谐振器(6)和该振动元件彼此有效连接地形成一个振动单元(3),该谐振器(6)能与该植入假体(7)有效连接以传递该机械振动并被设置用来将该植入假体(7)压在该组织部分上,并且所述植入装置还包括支撑在外壳上的植入假体导向装置。
15、如权利要求14所述的植入假体,其特征在于,该植入装置被设计用于以2kHz-200kHz频率使该谐振器(6)机械振动。
16、如权利要求14或15所述的植入假体,其特征在于,能调节出该机械振动的不同的频率、频率图形和/或能量脉冲。
17、如权利要求14或15所述的植入假体,其特征在于,该谐振器(6)或该谐振器的远端部分是可更换的且能够被消毒。
18、如权利要求1或14所述的植入假体,其特征在于,该植入假体是一个附加的全套工具的一部分,所述全套工具还包括在机械振动的帮助下植入所述植入假体的说明书。
19、如权利要求18所述的植入假体,其特征在于,所述植入假体(7)有多个。
20、如权利要求19所述的植入假体,其特征在于,该植入装置(1)的谐振器(6)在远端上包括保持机构,该植入假体(7)为销状或榫楔状并且在近端包括匹配于所述谐振器保持机构的保持机构。
21、如权利要求19或20所述的植入假体,其特征在于,所述全套工具包括各种销状或榫楔状植入假体以及谐振器(6)或远端谐振器部分,它的远端表面对应于所述植入假体的近端横截面。
22、如权利要求19所述的植入假体,其特征在于,该植入假体(7)的至少一部分为销状,所述全套工具还包括其直径匹配于植入假体(7)的最大直径以便摩擦配合的钻孔件。
23、如权利要求19所述的植入假体,其特征在于,该植入假体(7)的至少一部分在带有开口(58)的套(13)内具有所述可液化材料,所述全套工具还包括至少一个谐振器(6)或远端谐振器部分,其横截面适合该套(13)的近端内部横截面。
24、如权利要求19所述的植入假体,其特征在于,所述全套工具还包括具有开口的导向装置(84)和至少一个谐振器(6)或远端谐振器部分,其横截面适应于该开口。
25、如权利要求19所述的植入假体,其特征在于,所述全套工具还包括用于该植入装置(1)的消毒覆盖物。
26、如权利要求19所述的植入假体,其特征在于,能在该植入装置(1)上调节出不同的振动频率、频率图形和/或能量脉冲,所述全套工具还包括用于各种植入假体的调整说明书。
27、如权利要求5所述的植入假体,其特征在于,为了将该植入假体固定在一个板(21)中,所述植入假体的近端区域包括能够通过机械能被液化的材料。
28、如权利要求5所述的植入假体,其特征在于,它包括一个尖头形近端区。
29、如权利要求5所述的植入假体,其特征在于,所述可液化材料被布置在植入假体远端的植入假体表面上和/或在圆柱形植入假体表面上,所述可液化材料具有作为能量定向发送器的阶梯面。
30、如权利要求9所述的植入假体,其特征在于,所述保持机构设置用于传力配合连接。
31、如权利要求14所述的植入假体,其特征在于,所述谐振器被设置用于传力配合连接。
32、如权利要求19所述的植入假体,其特征在于,它包括许多销形植入假体和至少一个具有多个开口的板(21),这些开口适应于销形植入假体(7)。
33、如权利要求32所述的植入假体,其特征在于,所述板(21)是金属的,为了与所述板(21)连接,销形的所述植入假体(7)的近端区域包括能通过机械能被液化的材料,这些开口设置用于与所述可液化材料形状配合连接。
34、如权利要求33所述的植入假体,其特征在于,这些开口具有螺纹。
35、如权利要求32所述的植入假体,其特征在于,所述板(21)和/或销形所述植入假体的近端区域包括可液化材料,因而所述板和所述植入假体的所述近端区域能通过施加机械振动被焊接或粘结在一起。
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2002
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- 2002-03-04 AU AU2002233103A patent/AU2002233103B2/en not_active Expired
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