CN1688263A - 被植入骨组织或补充有骨代用材料的骨组织中的植入物 - Google Patents

被植入骨组织或补充有骨代用材料的骨组织中的植入物 Download PDF

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Publication number
CN1688263A
CN1688263A CNA038246228A CN03824622A CN1688263A CN 1688263 A CN1688263 A CN 1688263A CN A038246228 A CNA038246228 A CN A038246228A CN 03824622 A CN03824622 A CN 03824622A CN 1688263 A CN1688263 A CN 1688263A
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Prior art keywords
implant
surf zone
bone
core
type
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Granted
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CNA038246228A
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CN100506186C (zh
Inventor
J·迈尔
M·埃施利曼
L·托里亚尼
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Woodwelding AG
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Woodwelding AG
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Abstract

本发明涉及供植入到骨组织中的植入物,例如,牙科植入物或整形外科用的植入物。这一植入物具有:第一类型的表面区域(4),它具有例如骨整合,抗炎症,抗感染和/或生长促进性能,和第二类型的表面区域(8),它由能够由机械振动液化的材料组成。该植入物被放置在(例如颌骨的)开口的内部,接受机械振动的作用(例如超声波),和压住在颌骨上。在这一方法中,可液化的材料被液化和压入到周围骨组织的不规则区域和孔隙中,在再固化之后,它在植入物和骨组织之间形成正面连接。第一类型和第二类型的表面区域的合适排列和尺寸设计会导致在植入过程中已液化材料至多以临床不相关的量在第一类型的表面区域(4)上流动,因此这些表面区域的生物整合性能在植入之后立即起效。由于正面连接,该植入物获得很好的一级稳定性,据此能够在植入之后立即处于应力之下。这防止了由于未让植入物处于应力下所引起的消极效果的发生并将植入物和骨组织之间的相对运动减少到在植入之后有助于所需骨整合的那一生理允许程度。

Description

被植入骨组织或补充有骨代用材料的骨组织中的植入物
本发明属于医学技术领域并涉及根据第一个独立专利权利要求的序言的植入物。该植入物是被植入到人或动物骨组织中或植入到补充有骨代用材料的骨组织中。
根据本发明的植入物例如是牙科植入物,它(起着自然牙根的作用)被植入到颌骨中,和为了紧固人造牙冠,架桥或牙科修补物例如包括在其近端的固定部位,后者在植入之后位于骨表面的区域中。牙科植入物代表了完全牙齿替代品,就是说除了被植入的牙根区域之前还具有牙冠区域。该植入物也可以具有不同的功能并适合于在其它人或动物骨中植入。一般而言,该植入物用于将骨部分与另一组织部分,尤其与另一骨部分,或与人造部分相连接,该人造部分可以支持或替代骨部分(例如人造关节)或牙齿或它可以是治疗辅助设备(例如药物释放设备,引流设备或用于电或化学刺激的刺激设备)。该植入物可以进一步是治疗自动装置本身或它可以用于替代缺少的骨组织或可能的需要再生的骨组织(例如在肿瘤的摘除之后)或它可以是以所需方式增强自然骨的增强元件。
以具有固体位置的上述牙科植入物为基础的牙齿替代结构(单个牙齿,一组牙齿,部分修补物或完全修补物)的固定根据现有技术的状态是在下列步骤中实现的,例如:在自然牙根的除去之后需要一直等待到自然再生的骨组织填充在颌骨内的开口为止。在再生的骨组织中形成了与植入物适配的开口。该植入物被放置在开口中,其中开口是足够的深以便容纳完整的植入物,它因此没有伸出到开口之外。在植入物的近面上确定紧固位置的内部穿线用封盖螺钉封闭。该牙床(gum)被封在该封盖螺钉上和一直等待到骨组织向内生长与植入物成为一体为止和因此具有足以承受预期的负荷的稳定性(二级稳定性)。然后,在附加的步骤中,在植入物上的牙床被打开和封盖螺钉被测距仪(distancer)替代,其中测距仪伸出到牙床之外。只有当在测距仪周围的牙床已愈合时,牙齿替代结构才紧固于植入物上。该简要描述的程序必然让患者有十二到十八个月的治疗时间,其中的两个到三个月属于在植入与骨组织在植入物周围生长或植入物在骨组织内向内生长的时间点之间的一段时间,这样植入物具有足够的承受负荷的稳定性。
如果使用在形状上尽可能精确地与最初开口适配的植入物,则第一等待时间(在颌骨的开口内骨组织的再生)可以避免或缩短,如在出版物US-6132214(Suhonen等人.)中所述。
根据现有技术状态的牙科植入物通常由纯钛或钛合金组成。这些材料显示出非常好的生物相容性并且有多种已知的进一步改进骨整合的表面设计。植入物经常还包括允许骨组织生长到植入物之中的宏观结构。然而,这些已知牙科植入物的稳定性仅仅在完全的骨整合之后对于全负荷是足够的,即只有当它们周围紧密地生长了骨组织或向内生长或交互生长了骨组织(二级稳定性)时。在例如老年患者的骨质疏松的或软的骨中,以及在弱再生的骨组织中,偶然发现无法能够实现足够的植入物稳定性。
以上所述的牙科植入物的一级稳定性,即直接在植入之后的它们的稳定性,是非常有限的。因此之故,在植入和进一步构造之间增加了上述等待时间。上述植入物的一级稳定性将根据植入物形式来变化,但在大多数场合下它对于全负荷是不足够的。具有穿线的针状植入物限制性地可承受张力和压缩力和可能有的横向力,尤其当被植入而使得至少一个穿线圈位于骨的皮质部分的区域之内时。它们几乎不能承受扭转力。不具有圆形横截面的,即与自然牙根适配的植入物在承受扭转力时是更稳定的,但是当承受张力时不太稳定。上述情况也适用于片状牙科植入物,后者也可能包括多个的固定位置。
已知的牙科植入物的不足够的承载能力,紧接着在植入之后承受负荷时,将导致在植入物和骨组织之间的运动,该运动足以妨碍或甚至防止骨整合。然而,植入物的立即负荷不仅是缩短治疗时间所希望的,而且是避免由于无负荷所引起的颌骨的萎缩所需要的,即,利用只能通过为稳定的植入物施加负荷所能够实现的在植入物和骨组织之间的微小运动(不超过生理量度)来促进骨整合。
一级稳定性,尤其在张力和压缩力下承受负荷的能力,对于根据现有技术状态的针状植入物来说是通过合适形成的穿线(US3499222),通过张开的元件(例如US5766009,EP1 184006)或通过颈圈状元件来提高的。尤其用于紧固丝线或缝线的锚状植入物被配备倒剌状表面结构(US-4360343)以提高有关拉伸载荷的一级和二级稳定性。然而,这些改进皆不容许直接在植入之后的植入物的负荷。
因此本发明的目的是提供适合植入在骨组织中或在补充有骨代用材料的骨组织中的植入物,该植入物具有非常良好的一级稳定性,使得它例如能够在植入之后立即承受负荷,而且该植入物还能够用于其它临床功能,例如用于骨整合,让颗粒物或分子进出该植入物(输送或引流),用于电或化学刺激等和这也是紧接着在植入之后。植入物的附加临床功能不会因为所需要的一级稳定性而受到临床上相关的限制。如果该植入物具有例如负荷承载功能,即如果它是例如牙科植入物,则紧接着在植入之后或在植入之后至少比已知的此类植入物早得多的时候尽可能无限地荷载,然而其中骨整合(附加的临床功能)保持基本上不受阻碍,即紧接着在植入之后开始,从而使得由早期加载负荷所实现的对骨整合的上述正面效果能够完全地被利用。此外,根据本发明的植入物或它的植入都不比根据现有技术的那些更加复杂。
这一目的是通过在专利权利要求中所定义的植入物来实现。
根据本发明的植入物的表面,它与骨组织接触或例如在其周围生长骨组织或交互生长骨组织,包括了第一类型的区域和与第一类型的表面区域不同的第二类型的区域。
第一类型的表面区域是以本身已知的方式发挥一种或一种以上的预定临床功能。此类临床功能的例子是为了良好二级稳定性所需要的骨整合的促进或至少启动,治疗有效的化合物输送进入到该植入物周围的组织中,不需要的化合物从植入物周围的组织中除去(引流)或包围该植入物的组织的电或化学刺激。
对于例如具有负荷承载功能的植入物,第一类型的表面区域包括例如适合于与有生命力的骨组织之间的稳定向内生长或贯穿生长的一些结构和它们至少考虑到骨整合生物活性。此外或另外具有例如骨整合性,抑制炎症,抗感染,生长促进效果的化合物可以被输送通过第一类型的表面区域或这些表面可以用作治疗有效性刺激脉冲的通道。
第一类型的表面区域是例如生物相容性表面(例如由钛构成)和它们能够在形成后具有适合于骨组织向内生长的结构。此类表面可以进一步地涂有包括磷酸钙的材料,它们可以通过例如膦酸盐或肽序列来改性和/或它们可以包括含有例如生长因子的凝胶或聚合物。
第二类型的表面区域经过设计产生一级稳定性。为此目的,这些区域包括能够由机械振动所液化的材料,即具有热塑性能的材料(热塑性塑料或包括热塑性组分的复合材料)或触变水泥,其中可液化的材料通过在植入过程中机械振动(例如超声波振荡)的应用被液化和压入到包围该植入物的骨组织的不规则处,孔隙或适当产生的几何结构中。
构成第二类型的表面区域的材料早已在植入之前形成了植入物的外表面的一部分或它处于植入物的内部并在植入过程中它以液化状态加压穿过相应开口到达植入物的外表面,在这里就地产生了第二类型的表面区域。
为了让第二类型的表面区域的液化材料能够在植入过程中被压入到骨组织中,第二类型的表面区域以某种方式排列以使得它们在将植入物放置于骨中之后与骨组织接触。这意味着第二类型的表面区域例如伸出至少局部地超出了第一类型的表面区域或它们位于植入物边缘,凸出部等之上。对于内部含有形成第二类型的表面区域的材料的植入物,因此排列了用于压出可液化材料的开口。
两种类型的表面区域进行排列以及可液化的材料和/或液化是以某种方式来设计尺寸,使得第二类型的表面区域保持尽可能没有已液化材料。这确保第一类型区域的附加临床功能不受妨碍或仅仅妨碍到临床上可接受的程度,甚至紧接着在植入之后。随即例如实现:第一类型的表面区域的骨整合不仅不受妨碍而且不延迟和因此紧接着在植入之后就开始。
对于在植入过程中在植入方向上相对于骨组织移动的植入物,两种类型的表面区域的分离是通过将两种类型的表面区域彼此紧挨着和平行于植入方向进行排列来实现。
按照与已知植入物相同的方式,根据本发明的植入物在开口中被植入,该开口可能在例如颌骨的预先再生的骨组织中为植入物所特定地产生,其中这一开口可以容纳整个植入物(牙根区域)或其中以自切(self-cutting)方式的该植入物可以受力的作用比开口更深地进入到骨组织中。该开口可以例如仅仅涉及到皮层质骨层或,由于有植入物的合适设计,它可以完全地省略。根据本发明的植入物也可以在复制的意义上具有与骨腔的不规则形相适配的形状,例如所摘除的自然牙根的形状并可以直接植入到这一空腔中。
根据本发明的植入物是,例如,具有针或自然牙根的形状并具有在其近端的固定位置(例如具有穿线的袋形孔或具有由牙科医生可以产生该袋形孔的位置)或人造牙冠区域的牙科植入物。在它的远端处,它可以形成为凿子形状和/或具有侧部自切或凹槽结构。它可以进一步是板形,圆盘形或刀形并包括一个或多个紧固位置,或它可以具有锚的形状,例如线或缝线能够紧固在其上。
根据本发明的植入物是单件式的并包括例如由不同材料组成的以上所定义的、不同的表面区域,或它在内部含有可液化的材料并包括开口,该材料当液化时经由该开口被压出到植入物的外侧。该植入物也可以是两件式或多件式的,其中外科医生将各种材料的两个或多个部分混合而形成植入物。
为了植入,根据本发明的植入物位于骨(或补充有骨代用材料的骨组织)之中,例如在颌骨之中,的开口中,和然后将机械振动(例如超声波)应用于它,和同时它被压住在骨上。这引起可液化材料的至少一部分被液化和压入到外围骨组织的孔隙,表面不规则处和/或所产生的几何结构之中,其中在固化之后在植入物与外围骨组织或可能的骨代用材料之间形成正面配合连接。取决于该植入物设计,在液化的同时该植入物也可以推进到骨组织(植入方向)。
为了对放置的植入物施加机械振动,超声波装置的超声焊极例如被放置在植入物的近端。实验表明,以0.2-20W/每平方毫米活性表面的功率能够获得良好的结果。振动的频率是在2-200kHz之间。
根据本发明的和具有负荷承载功能的植入物(例如牙科植入物)包括例如带有第一类型的表面区域的植入物中心部分并由例如金属(例如钢,钛,钴/铬合金),陶瓷或玻璃状材料(例如氧化铝,氧化锆,陶瓷或磷酸钙型玻璃),热固性或高温热塑性聚合物(聚醚芳基酮,聚氟-或聚氯乙烯,聚醚酰亚胺,聚醚砜,聚氯乙烯,聚氨酯,聚砜,聚酯)或复合材料(例如用碳纤维增强的高温热塑性塑料)制得。此类植入物还包括可液化材料(例如具有热塑性能的材料)的植入物周边部分。可液化材料也可以放置在中空的植入物中心部分的内部,其中植入物中心部分的壁具有贯通式开口,液化的材料在机械振动的影响下经由该开口被压出,以便在壁的外侧上形成第二类型的表面区域。植入物各个部分可以在制造厂家那里彼此连接或仅仅直接在植入之前或过程中由外科医生将它们彼此连接。
不具有相关的负荷承载功能的根据本发明的植入物(例如具有输送功能,引流功能或刺激功能的植入物)也可以包括植入物中心部分和植入物周边部分,该植入物周边部分至少部分地由可液化的材料组成,其中对于植入所需要的机械稳定性(负荷承载功能)可以由植入物周边部分所接替,该植入物中心部分具有非常少的机械稳定性。植入物中心部分例如是多孔磷酸钙的或具有低机械稳定性的其它骨代用材料的或薄膜的渗透性容器,其中在整个容器壁发生输送或引流或刺激。植入物中心部分也可以是例如多孔磷酸钙或另一种骨代用材料的结构体并具有引发或协助所缺少或另外想望的骨组织的形成的功能。还有可能在植入物中心部分的内侧上提供可液化的材料并在液化时将它加压穿过相应的开口到达植入物中心部分的外表面,即使后一植入物部分具有小的机械稳定性。
根据本发明的植入物也能够由仅仅一种材料组成,它同时能够满足对于植入物和可能的固定位置的机械强度而言的要求,由第一类型的表面区域的附加临床功能所设定的要求(例如分别地,生物整合或二级稳定化)以及利用机械振动的液化性能的要求。视情况而定,在植入物的各个区域中,一种材料可以填充到不同的程度(例如用纤维,晶须或颗粒)或它可以用不同的材料填充在不同的区域中。同样在这一情况下,被整合在骨组织中的表面区域的合适设计必须确保在植入之后,第二类型的表面区域或已液化的材料分别地尤其与骨组织接触和已液化的材料没有或仅仅在临床不相关的程度上被携带到第一类型的表面区域上。
对于具有用于骨整合的表面区域的植入物,可液化的材料理想地是至少部分地生物可降解的(可再吸收的),因此在植入物和骨组织之间的正面适配(positive fit)的稳定性功能(一级稳定性)逐渐地被骨整合的稳定性功能(二级稳定性)所接替,这理想地提高到与可液化的材料被再吸收时相同的程度,即一级稳定性下降。尤其对于疏松骨组织或不充分再生的骨组织,有利的是永久地保留一级稳定化作为二级稳定化的补充,即使用不可再吸收的、可液化的材料,它也适用于良好的生物整合(二级骨整合)。
对于不需要有负荷承载功能的植入物,可液化的材料有利地是至少部分地可再吸收的,如果植入物从骨组织中除去或完全地被骨组织替代。如果需要保留一级稳定性,可液化的材料不是可再吸收的或仅仅部分地可再吸收的。
例如以乳酸和/或乙醇酸为基础的可再吸收的聚合物(PLA,PLLA,PGA,PLGA等)或聚羟基链烷酸酯(PHA),聚己内酯(PCL),多糖,聚二氧杂环己烷酮(PD),聚酐,多肽或相应共聚物或含有上述聚合物作为组分的共混聚合物或复合材料都适合作为可再吸收的可液化的材料。热塑性塑料如聚烯烃,聚丙烯酸酯,聚甲基丙烯酸酯,聚碳酸酯,聚酰胺,聚酯,聚氨酯,聚砜,聚芳基酮,聚酰亚胺,聚苯基硫化物或液晶聚合物(LCPS),聚缩醛,卤代聚合物,尤其卤代聚烯烃,聚苯硫醚,聚砜,聚醚或相应共聚物或含有上述聚合物作为组分的共混聚合物或复合材料都适合作为不可再吸收的聚合物。可应用的触变体系是可再吸收的,部分地可再吸收的或不可再吸收的聚合物,陶瓷或水硬水泥(例如Synthes公司的Norian或Centerpulse的Sulfix)。
可液化的材料可以含有发挥其它功能的外来相或化合物。尤其,可液化的材料可以通过掺混纤维或晶须(例如磷酸钙陶瓷或玻璃)来增强和这代表了复合材料。可液化的材料可以进一步含有就地膨胀或溶解(产生孔隙)的组分(例如聚酯,多糖,水凝胶,磷酸钠)或需要就地释放和具有治疗效果(例如愈合和再生的促进)的化合物(例如生长因子,抗生素,炎症抑制剂或防止酸性分解的不利影响的缓冲剂如磷酸钠)。如果可液化的材料是可再吸收的,此类化合物的释放会延迟。
不包括可液化材料的植入物部分不是可再吸收的,如果植入物将保留在患者体内或如果它通过手术被除去。然而这一植入物部分也可以至少部分地由可再吸收的材料组成,它在植入之后逐渐地被有生命力的组织替代。
植入物的设计和可液化材料的选择需要以某种方式彼此匹配,使得正面适配的强度足以满足预计荷载的需要,和使得液化有合理的即尽可能低的放热。如果使用具有较高软化温度的可液化材料,理想的是确保植入物整个地(包括可液化的材料)随共振器进行机械振动,这样可液化的材料在第二类型的表面区域中仅仅非常局部地,例如仅仅在适当提供的能量导向器的区域中被液化。如此,释放的热量能够保持在可接受的范围内。尤其,当使用具有较低软化温度的材料或材料是可液化的但没有放热(例如触变水泥)时,液化也可以在可液化的材料之内(通过该激发振动的大衰减)或在植入物中心和周边部分之间的接触部位进行。
在植入过程中对组织的热负荷可以甚至进一步通过设计该植入物中心部分使之包含具有大的导热能力和/或大的热容量的材料(例如碳化硅)和视情况而定,使之包含有冷却介质流过的冷却通道来减少。
根据本发明的植入物的举例性实施方案利用下面的附图来详细地描述,其中:
图1,2A,2B,2C显示了根据本发明的基本上针形的植入物的三个第一种示例性实例(例如牙科植入物),该植入物包括植入物的中心和周边部分,(图1:侧视图,图2A到2C:横截图);
图3显示了根据本发明的植入物的第二种示例性实例(例如牙科植入物),该植入物包括植入物的中心和周边部分,其中植入物的形状与在骨中存在的空腔(例如自然牙根从颌骨中的除去所引起的空腔)相适配;
图4和5显示了根据本发明的植入物的两种附加实例(例如牙科植入物),该植入物包括植入物的中心和周边部分,其中该植入物中心部分与在骨中存在的空腔适配(例如是自然牙根的模仿)和被设计成自切或凹槽(横截面);
图6显示了根据本发明的植入物的另一基本上针形的实例(例如牙科植入物),该植入物包括植入物的中心和周边部分(侧视图);
图7和8显示了根据本发明的植入物的示例性实例,该植入物成形为锚形(图7:侧视图;图8:横截图);
图9和10作为侧视图(图9)和平面视图(图10)显示了根据本发明的板形,圆盘形或刀形植入物的示例性实例(例如具有两个紧固位置的牙科植入物);
图11和12显示了根据本发明的基本上针形植入物的示例性实例(例如牙科植入物),该植入物包括中空的植入物中心部分(图11:纵剖面图;图12:平面视图)。
图13显示了根据本发明的植入物的示例性实例,该植入物包括没有相关机械稳定性的植入物中心部分;
图14显示了作为根据本发明的植入物的附加实例的强化元件;
图15和16(各自的A、B和C)显示了,在三维插图(图15A和16A)中,在侧视图中在两根椎骨之间植入过程中(图15B和16B),和当植入时作为前视图(图15C和16C),用于连接两根脊椎骨的植入物的两个实例。
图1和2A到2C显示了根据本发明的植入物的示例性、针形实例,该植入物具有负荷承载功能和因此是例如牙科植入物或例如用于稳定化骨折或固定支持板或作为人造关节部件的轴(例如髋,膝,肩或手指关节)的整形外科用植入物。该植入物包括植入物中心部分1和植入物周边部分2,其中该植入物中心部分包括在其近端的例如紧固位置3(例如具有内部穿线的袋形孔或由外科医生产生此类袋形孔的位置)。植入物远端例如设计成凿子形以发挥自切效果。该植入物也可以,如在根据图2C的横截面视图中所示,包括轴向扩展、自切或凹槽型元件9。该植入物中心部分1包括平行于植入方向A扩展的第一类型的表面区域4(例如具有骨整合,炎症抑制,抗感染和/或生长促进性能)。在第一类型的表面区域4之间,该植入物包括适合于连接到植入物周边部分2的表面。在植入物周边部分2和植入物中心部分之间的连接可以是粘合剂连接5(图2A)或正面适配连接,例如具有窄的开放式槽缝的独立凹槽5’(图2A和2C)或具有多个开口或凹槽的表面5”(图2B)。植入物周边部分2包括手指状部分6,它例如适配到凹槽5’中或在表面区域5”之上和它形成了第二类型的表面区域8的至少一部分。
如在图2A到2C中所示,本发明对于针形植入物的横截面没有设定任何条件,因此这可以根据功能来选择。因此,除了在三个图2A到2C中显示的那些以外的其它截面视图都是可以想象的,例如具有圆形横截面的植入物中心部分和位于其上面的手指形部分6,如图2A所示。
在图2C中显示的植入物尤其能够以例如基本上自切方式被敲入骨组织中。为了防止液化的材料被驱动到第一类型的表面区域4之上,第一类型和第二类型的表面区域(4和8)彼此紧挨着和平行于植入方向A而扩展。在植入路径是仅仅短的近侧区域中,手指形部分6可以直通进入到沿植入物中心部分1延伸的环6’中和理想地保持在植入物中心部分的凹槽中。环6’不仅将手指形部分6聚集成内聚性的植入物周边部分2(它对于可能由外科医生容易地连接两个部分是有利的),而且构成了在植入物和皮层质骨组织之间的紧密一级稳定化(尤其对于张力和扭转)的一种方式。如果合适的话,在皮层质骨中产生穿线或类似结构,这样环6’能够由正面适配连接到这一相对致密骨层。
为了将植入物放置于更深的开口中和在振动过程中不发生位移或仅仅轻微地位移,第一和第二类型的表面区域可以不同地排列。第二类型的表面区域8可以形成,代替手指形部分6,例如点或交叉线的图案。第二类型的表面区域8的排列因此适合于植入的方式。此外,第二类型表面区域的排列适合于由液化的材料所实现的一级稳定性,即无法由植入物形状实现的一级稳定性。
在图1和2A到2C中示出的植入物的两个植入物部分1和2可以由制造厂家彼此连接。植入物周边部分2例如可以通过直接注射模塑到植入物中心部分1上来制造。两个植入物部分1和2也可以单独制造和一直到直接在植入之前为止才由外科医生连接在一起。在这种情况下,理想的是在植入过程中在两种材料之间实现正面适配或粘合剂连接,这样植入物周边部分2的材料被液化和例如被压入到植入物中心部分的根据图2B的开口或凹槽中。为此需要提供植入物周边部分2的内侧或植入物中心部分1的有能量导向器的相应表面。
由外科医生接合在一起的优点在于以下事实:两个部分能够单独地消毒,即可能使用与这两部分的各种功能相适应的不同方法。整个植入物的杀菌不是必须的。临到植入前接合在一起可以允许制造厂家制造出例如在长度和直径上彼此不同的植入物中心部分和例如在材料或手指形部分厚度上不同的植入物周边部分的组合件,这样外科医生本人对于所述情况精确地组装合适的植入物(在较低数量的组分下更大的可变性)。
为了植入根据图1和2A到2C的针形植入物,使用植入设备(例如超声波设备的超声焊极(sonotrode)),该设备具有基本上与植入物的近面相适应的远端。如有必要,偶联件可以引入在超声焊极和植入物之间。该振荡能量有利地施加于植入物中心部分。
图3显示了根据本发明的牙科植入物,它原则上按照与根据图1的植入物同样的方式设计,但形状不同于已知的针状或螺钉状植入物,而是等同于在骨中的自然空腔,在所举例的情况下等同于自然牙根。在由植入物周边部分2形成的第二类型的表面区域8之间,即在第一类型的表面区域4中,植入物中心部分1具备一些结构,允许例如穿线在再生的骨组织中有改进的锚固作用(二级稳定性)。
图4和5以横截面显示了根据本发明的植入物的附加实例,它适合被植入到现存的骨空腔中,例如在由自然牙根的除去所产生的空腔中。植入物与具体的空腔相适配和包括轴向扩展,自切或凹槽型元件9。两种植入物的植入物中心部分1由携带例如紧固位置3的针形部分1.1(负荷承载部分)或人造牙冠和主体部分1.2组成。主体部分1.2是在复制意义上,例如通过使用所除去的牙根,在外部成形,例如按照在出版物US-6132214(Suhonen等人)中所述,或就地成形,即在相应的空腔中。
根据图4的主体部分1.2形成了第一类型的表面区域4(例如具有骨整合,炎症抑制,抗感染和/或生长促进性能)并由有利地可再吸收的或部分地可再吸收的骨代用材料(例如磷酸钙,聚交酯,填充磷酸钙的不可再吸收的聚合物,有增强组分的混合物体系)组成。植入物周边部分2限于自切或凹槽型元件9,例如可液化材料的针状部分被引入其中。
根据图4的植入物可以在两个相继的步骤中植入。首先在存有的空腔中填充一件骨代用材料(主体部分1.2)。然后针形部分被植入,其中通过可液化材料(植入物周边部分2)的锚固可以至少部分地影响该骨代用材料。此类情况由点划线在图4中示出。
根据图5的主体部分1.2是由可液化材料的较薄和尽可能柔性的层形成,即,由形成第二类型的表面的植入物周边部分2包围。代替该薄层,也可以提供至少部分地涂有可液化材料的膜。轴向扩展,自切或凹槽型元件9包括第一类型的表面4。主体部分1.2由塑性、可固化材料,例如骨胶接剂(它可以由光,超声波或加热所固化)或水硬性水泥(该胶接剂优选具有触变性能)组成。在引导到空腔中之后,主体部分1.2呈现空腔的形状。在施加机械振动时,不仅第二类型的表面区域的可液化材料被压入到周围骨组织的孔隙和不规则处,而且该主体部分与空腔的形状适配和也可能固化。可液化材料有利地是可再吸收的,这样由第二类型的表面区域8产生的一级稳定性被二级稳定性所接替,该二级稳定性首先由主体部分1.2的骨整合所引起和然后在主体部分的再吸收之后由针形部分1.1的骨整合所引起。
被设计为牙科植入物的根据图4和5的植入物可以基本上直接在自然牙根的除去之后被植入在颌骨中,因为它们的形状与由除去所产生的空腔相适配。幸亏一级稳定性由第二类型的表面区域8所实现,它们也可以立即荷载,因此引起细微运动,以生理措施加速在主体部分1.2和随后针形部分1.1的的第一类型的表面区域中的骨整合。该牙科植入物因此更缩短了治疗时间,甚至与根据图1到3的植入物相比。这同样适用于为了在除了颌骨以外的其它骨中的植入所设计的植入物。
图6显示了根据本发明的植入物的附加针状实例(例如牙科植入物,用于骨折的固定的植入物,用于固定支持板的植入物,人造关节的轴),该植入物包括植入物中心部分1和植入物周边部分2。植入物中心部分1包括贯通式开口和/或非贯通式开口11以便让骨组织交互生长,例如可液化材料的针形插件12插入在该开口中伸出到植入物中心部分1的表面以外并由摩擦接头(friction fit)稳固地保持住。针形插件12一起形成植入物周边部分2,针形插件的末端从在第二类型的表面8上的开口11伸出。
图7和8以侧视图和横截视图显示了根据本发明的植入物的锚状实例。这一实例的紧固位置3例如是作为孔眼而形成的。该锚具有本身已知的形状并包括在其长度上延伸的槽缝,可液化材料的针形插件(植入物周边部分2)是以正面适配被排列在槽缝中。该针13在两侧伸出而超出了锚的表面。锚形植入物,作为已知的此类锚状植入物,可以包括附加的倒刺14,它在张力负荷下被压入到骨组织中,使得由植入物周边部分2追加正面适配锚固。然而,此类倒刺或类似的保留机构决不是必需的。
锚边缘作为刀片的设计简化了植入,在骨组织中或在仅仅涉及皮层质骨的开口中无需使用合适的开口。
图9和10显示了,作为根据本发明的植入物的附加举例性实例,板形的、圆盘形的或刀形的牙科植入物,它例如包括两个固定位置3或两个人造牙冠和它的植入物周边部分2由多个针状部分13组成,后者位于在板、圆盘或刀中的贯通式开口内和在植入物中心部分的凹槽中的紧固位置的区域中。
该板-,圆盘-或刀-形牙科植入物,其中的一个例子示于图9和10中,从颌脊放置在颌骨中,与在机械振动的施加过程中的针形牙科植入物相同(植入方向A,图9)。然而,它们也可以从侧边放置在颌骨中(植入方向A’,图10),为了进行该植入需要除去颌骨的一部分和在植入之后再放置。
板-,圆盘-或刀-形植入物不仅适用于牙科领域而且适用于整形外科领域,为此它们包括适当准备的近侧区域。
图11和12以纵剖面图和作为平面视图显示了根据本发明的植入物的其它针形实例(例如牙科植入物或整形外科用的植入物)。该植入物中心部分1被设计为具有内部空间2’的套筒,该可液化的材料包含在其中。该套筒壁包括贯通式开口或槽缝20,它们例如以轴向的列进行排列或轴向扩展。植入物放置在骨腔中和振动元件21(超声波装置的超声焊极)放置在植入物中心部分的内部空间2’中的可液化材料之上,对这一材料施加振动和同时将它压向植入物远端。利用振动该材料被液化和利用压力它加压通过开口或槽缝20进入周围骨组织的表面不规则处和孔隙中,因此产生了主要使植入物稳定化的正面适配。
如果该植入物中心部分1具有所示的凿子状的远端,则根据图11和12的植入物无需开口就能够敲入骨组织(至少松质骨)中。环形的超声焊极22适合于此。超声焊极21一直作用到植入物已经到达在骨中预定位置为止。
在根据图11和12的植入物中,实际上只有当植入物处于骨组织时产生植入物周边部分,即它就地产生。
在植入物中心部分的内部空间2’中提供的可液化材料可以是排列在植入物中心部分之外的热塑性材料如可液化材料。然而有利地,它是聚合物或具有触变性能的水硬水泥,该胶接剂是植入之后可通过例如紫外光,加热,机械振动或简单地随时间推移来固化。
当将热塑性塑料用作在植入物中心部分的内部空间2’中提供的可液化材料时,能量导向器可以排列在植入物中心部分1的内表面上或在热塑性塑料的表面上。
根据图10和11的植入物的可液化材料可以由制造厂家或由外科医生引入在植入物中心部分1中。它作为许多单独的部分被引入或它通过超声焊极加压基本上连续地进入到植入物中心部分1。
图13显示了根据本发明的植入物的附加示例性实例。与根据前面的图的植入物相反,这一植入物不是为了负荷承载功能所设计,而是例如为了释放治疗有效化合物,为了引流(drainage),为了组织或器官的电或化学刺激或为了类似功能。
该植入物周边部分至少部分地由可液化材料组成(第二类型的表面区域8)和被设计为对于植入具有足够稳定性的骨架构造(cage)。不具有任何负荷承载功能的植入物中心部分被排列在骨架构造的内部。将植入物放入到骨腔中和由与植入物的近端面相适应的设备(超声波设备的超声焊极)对其施加振荡能量。用于根据图13的植入物的超声焊极具有空心圆柱体的形式。
构成根据图13的植入物的第一类型的表面区域4的植入物中心部分具有例如骨整合功能并由例如高孔隙度的磷酸钙,的骨碎片(患者本身的松质骨)或凝胶组成。这一中心部分也可以是一种设备,由该设备将颗粒物或分子释放到周围组织(输送设备)或从周围组织(引流设备)或刺激物中除去,其中该设备例如被设计为包括壁(它构成第一类型的表面区域4)的相应渗透性容器。
根据图13的骨架构造可以由制造厂家装有植入物中心部分或它可以在手术室中填充例如骨碎片。同样有可能将该骨架构造以空的构型植入和就地为它装配植入物中心部分,其中保持植入物中心部分在应有位置的覆盖元件可以被放置和由超声波焊接法就地紧固。
图14显示了作为根据本发明的植入物的附加例子的强化元件31,它适用于产生除了自然骨组织以外的另外所需要的骨组织,例如为了扩大颌骨的脊32。这一脊32和强化元件31是以截面视图和以植入之后的状态被显示。该强化元件31包括由骨生长促进材料例如高孔隙度的磷酸钙组成的植入物中心部分1。可液化材料的针形插件被排列在植入物中心部分1的通孔(内部空间2’)中。为了植入,该强化元件31被放置在合适地准备的颌骨脊32上,使得针形插件例如对准该脊32。然后通过使用与针形插件的横截面相适应的超声焊极21,对针形插件施加振荡能量,同时将针形插件压向脊32。随即可液化材料至少部分被液化并压入到骨组织颌骨脊中和进入到强化元件的材料中以便将该强化元件31逐点地紧固于颌骨脊32中和让植入物中心部分1(第一类型的表面区域)与颌骨脊的骨组织紧密接触,使得紧接着在植入之后让植入物中心部分渗入了来自自然骨组织的细胞以促进骨形成。在这种情况下,可液化的材料有利地是可再吸收的。
图15A-15C和16A-16C显示了适合于连接两个椎骨的根据本发明的植入物的两个实例。再次该植入物包括植入物中心部分1,后者构成负荷承载支持体1.3和被排列在支持体内部和可被再生骨组织穿透的基体1.4。基体1.4例如由高孔隙度的磷酸钙,骨碎片或凝胶组成。植入物中心部分在形式上适配于自然脊椎骨盘和包括在它的上下侧上的脊40,后者在植入方向A上延伸并适配于需要在椎骨的骨组织中形成的凹槽。
植入物周边部分2在根据图15的实施方案中被排列在脊40上和在根据图16的实施方案中植入物周边部分的材料被提供在植入物中心部分1的内部空间2’中,该植入物中心部分1在脊40的区域中包括开口20。
根据图15A的植入物用超声焊极30推挤在如图15B中所示的两个适当准备的椎骨之间,其中植入物周边部分2的可液化材料被液化和压入到椎骨的骨组织中从而锚固该植入物,如图15C中所示。用于植入的超声焊极基本上与植入物的近端面相适配。
根据图16A的植入物被放置在如图16B中所示的两个椎骨之间,例如通过使用与植入物中心部分1的负荷承载支持体1.3的近端面基本上相适配的超声焊极30。当植入物被放置时,通过使用与内部空间2’的近端面相适配的超声焊极对可液化材料施加振荡能量。随即该材料被加压通过开口20并进入椎骨41的骨组织中从而将植入物锚固于椎骨中,如在图16C中所示。
根据图15和16的植入物在植入之后(一级稳定化)立即紧固于椎骨上。因此不需要按在类似的现有技术程序中所已知的那样将两个椎骨稳定化。这使植入物特别适合于最低限度介入式操作。

Claims (23)

1.植入到人或动物骨组织或补充有骨代用材料的骨组织中的植入物,其中植入物表面的至少一部分与骨组织接触,特征在于植入物表面的这一部分包括第一类型的表面区域(4)和与第一类型的表面区域(4)不同的第二类型的表面区域(8),其中第二类型的表面区域(8)包括由机械振动可液化的材料和借助于该机械振动使得在由机械振动进行植入时该植入物至少实现一级稳定化,其中第一类型的表面区域(8)发挥与一级稳定化的功能不同的其它临床功能和其中第一类型和第二类型的表面区域(4,8)以一种方式进行尺寸设计和排列,使得在由机械振动进行植入时第一类型的表面区域保持至少部分地没有已液化材料。
2.根据权利要求1的植入物,特征在于第一类型的表面区域(4)的临床功能,该功能不同于一级稳定化,包括骨整合、颗粒物或分子从植入物渗透出来进入到在植入物周围的骨组织中或从植入物周围的骨组织渗透出来进入到植入物中,或电或化学刺激。
3.根据权利要求1或2的植入物,特征在于可液化的材料是具有热塑性能或具有触变性能的材料。
4.根据权利要求3的植入物,特征在于可液化材料是以乳酸和/或乙醇酸为基础的聚合物,聚羟基链烷酸酯,聚己内酯,多糖,多肽,聚二氧杂环己烷酮,聚酐,聚烯烃,聚丙烯酸酯,聚甲基丙烯酸酯,聚碳酸酯,聚酰胺,聚酯,聚氨酯,聚砜,聚芳基酮,聚酰亚胺,聚苯基硫化物,液晶聚合物,聚缩醛,卤代聚合物,尤其卤代聚烯烃,聚苯硫醚,聚砜,或聚醚或这些聚合物的共聚物或共混聚合物或含有此类聚合物中的一种的复合材料,或聚合物,陶瓷或水硬水泥。
5.根据权利要求1到4中一项的植入物,特征在于第一类型的表面区域(4)包括适合于由有生命力的骨组织向内生长或贯穿生长的结构。
6.根据权利要求5的植入物,特征在于第一类型的表面区域(4)进一步具有炎症抑制,抗感染和/或生长促进性能。
7.根据权利要求1到6中一项的植入物,特征在于第一类型和第二类型的表面区域(4,8)彼此紧挨着并平行于植入方向(A)来排列。
8.根据权利要求1到7中一项的植入物,特征在于它包括:包括第一类型的表面区域(4)的植入物中心部分(1),和排列在植入物中心部分之外的、至少部分地由可液化材料组成的和构成第二类型的表面区域(8)的植入物周边部分(2)。
9.根据权利要求8的植入物,特征在于第二类型的表面区域(8)至少局部地伸出到第一类型的表面区域(4)之外。
10.根据权利要求1到7中一项的植入物,特征在于植入物包括植入物中心部分(1),后者构成第一类型的表面区域(4)并包括可液化材料已排列或可排列在其中的内部空间(2’)中,其中内部空间(2’)由开口(20)连通到植入物中心部分(1)之外,这些开口经过尺寸设计让可液化材料当处于液态时加压穿过和它们排列在需要产生第二类型的表面区域(8)的范围中。
11.根据权利要求7到10中一项的植入物,特征在于植入物具有负荷承载功能和植入物中心部分(1)构成了植入物的负荷承载元件。
12.根据权利要求11的植入物,特征在于该植入物中心部分(1)至少部分地由金属,金属合金,陶瓷材料,聚合物或复合材料组成。
13.根据权利要求11或12之一的植入物,特征在于植入物中心部分(1)包括自切或凹槽型元件。
14.根据权利要求11到13中一项的植入物,特征在于植入物中心部分(1)包括负荷承载部分(1.1)和具有可变形状的基体部分(1.2)。
15.根据权利要求11到13中一项的植入物,特征在于植入物中心部分(1)包括负荷承载支持体(1.3)和基体(1.4)。
16.根据权利要求15的植入物,特征在于基体(1.4)包括骨代用材料,骨碎片或凝胶。
17.根据权利要求8到10中一项的植入物,特征在于植入物周边部分(2)可作植入物负荷承载部分。
18.根据权利要求17的植入物,特征在于该植入物中心部分(1)是具有渗透性壁的容器或由骨代用材料,骨碎片或凝胶组成。
19.根据权利要求1的植入物,特征在于它是牙科植入物,其包括至少一种紧固位置(3)或至少一种牙冠部分。
20.根据权利要求1的植入物,特征在于它用于整形外科应用。
21.根据权利要求19或20中一项的植入物,特征在于植入物是针形,板形,圆盘形或刀形或它已采取或可以采取与骨中预定空腔的形状相对应的形状。
22.根据权利要求20的植入物,特征在于它用于连接两个骨部分或紧固支持板或用作髋关节,指关节,膝关节,或肩关节的修补物的轴。
23.根据权利要求1的植入物,特征在于植入物具有脊柱盘的形状和包括在其上下侧的至少一个脊(40),其中第二类型的表面区域(8)排列在脊(40)的区域内。
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