CN107223041A - 用于由于感染双侧更换在肩部、膝部和髋部中的植入物的陶瓷间隔垫片(“Spacer”) - Google Patents
用于由于感染双侧更换在肩部、膝部和髋部中的植入物的陶瓷间隔垫片(“Spacer”) Download PDFInfo
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- CN107223041A CN107223041A CN201580065814.6A CN201580065814A CN107223041A CN 107223041 A CN107223041 A CN 107223041A CN 201580065814 A CN201580065814 A CN 201580065814A CN 107223041 A CN107223041 A CN 107223041A
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- spacing washer
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- spacer
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30721—Accessories
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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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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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Abstract
本发明涉及一种用于关节中的感染的临时手术治疗的作为在肩部、膝部和髋部的内置管术中的关节替代物的由各个部件(2,3,4,9,10,12)构成的间隔垫片(“Spacer”)(1)。为了避免骨头到间隔垫片处的生长和磨损产物的释出、患者基本上不受活动性限制且Spacer的磨损尽可能小,建议,即,间隔垫片(1)由至少一个由一种陶瓷材料或由多种陶瓷材料、或由带有陶瓷涂层的非陶瓷材料构成的部件构成。
Description
技术领域
本发明涉及一种用于关节中的感染的临时手术治疗的作为在肩部、膝部和髋部的内置管术中的关节替代物的由各个部件构成的间隔垫片(“Spacer”)。
背景技术
间隔垫片(也被称作Spacer)在关节内置管术的领域中是已知的且被临时用于由于内置管术治疗辅助细菌感染的医治且在医治阶段期间使得关节设备的机械的最小功能性成为可能。
在此,医治的该辅助通过抗生或抗菌物质的局部的、尽可能受控的给出实现。当Spacer至少具有下面的外形元件时,实现关节的最小功能性:
·在远侧的杆或柄,与人工髋部关节的杆或柄类似,其支撑在大腿骨髓管中的Spacer。
·在近侧的球段或球头,其可在受限制的范围中(尤其关于负荷变换和运动变换的次数)被连接在移除人工髋臼之后留下的髋臼空腔的半球中。
当感染在数周之后被治愈时,Spacer的寿命/应用结束、Spacer被移除且新的假体、必要时使用修复假体。
目前的Spacer系统大多数基于PMMA骨粘固剂,其与抗生有效成分(大多数为庆大霉素(Gentamicin)和/或万古霉素(Vancomecin))混合或者被填充且作为预制的植入物被提供或在外科手术期间利用所提供的材料混合物和模具来制造。
在此存在一系列负面影响患者的本质上的缺点或者限制(根据所使用的系统):
· 随着增加的在患者中的滞留时间,骨头生长到Spacer处的风险上升,这使得仅是临时的植入物的移除变得困难或者在移除的情形中导致非期望的骨头损失。该风险由于材料和造型特定的表面粗糙度和所使用的材料的化学生物特性在负面的方面被增加。
· 所使用的材料在摩擦学负载的情形中的较小的磨损强度格外地在患者的活动性上限制了患者。所释出的磨损产物(粘固剂颗粒以及粘固剂经常为了强度提高以其来填充的陶瓷颗粒)在某些情况下挑起负面的生物反应且增加在进一步的过程中所装入的假体由于所谓的三体磨损(Dritt-Korper-Verschleiss)的磨损风险。
· 临时Spacer的相比常规假体而言较小的机械强度导致如下,即,当Spacer由于断裂的失效应被避免时,患者须格外限制负荷(负荷的高度和负荷循环的次数)且进而格外限制其活动性。
·由于粘固剂间隔垫片的粗略的外形,在大多情况下仅可建立或者具有非常不精确的摩擦副,这导致关节的增加的磨损和不足的导向和稳定性。
发明内容
本发明所基于的目的是,如此地改善一种根据权利要求1的前序部分的间隔垫片或者Spacer,即,避免骨头到Spacer处的生长和磨损产物的释出。此外,患者应基本上不受活动性限制且Spacer的磨损应尽可能小,这可能导致关节的不足的导向和稳定性。利用本发明,这些缺点被消除且得出一系列在下面进行描述的另外的优点。
上述目的通过一种根据权利要求1的间隔垫片或者Spacer来实现。
通过使间隔垫片由至少一个由一种陶瓷材料或由多种陶瓷材料、或由带有陶瓷涂层的非陶瓷材料构成的部件构成,避免了骨头到Spacer处的生长和磨损产物的释出。此外,患者基本上不受活动性限制且Spacer的磨损尽可能小,从而不出现关节的不足的导向和稳定性。
优选地,带有与生物组织的接触的至少一个陶瓷部件的所有裸露面被磨光或被处理成,使得其表面粗糙度Ra小于0.35μm。骨头的生长因此被排除。
为了促进治疗过程,至少一个陶瓷部件至少在部分区域中携带有带有一种或多种抗生有效成分的一个涂层或多个涂层。
在一实施形式中,间隔垫片由带有伸出的容纳元件的陶瓷柄构成且在容纳元件上固定有金属套管且在该套管上锚固有陶瓷球头。间隔垫片因此由与传统假体相同的部件构成。
优选地,在柄与套管之间以及在套管与球头之间的联接通过锥形的夹紧连接实现或在柄与套管之间的联接作为基于截棱锥几何形状或形状配合地基于四边形几何形状的夹紧连接实现,以便于例如有助于柄通过陶瓷粉末的单轴干压的成型或材料配合地或者形状配合地在使用骨粘固剂的情形下实现该联接。
套管在容纳元件上也可经由一个或多个止挡部被夹紧。
为了防止柄在骨头中的转动,柄的接合到骨头中的区段在横截面上具有矩形或椭圆形的形状。
对于在膝部的内置管术中的关节替代物而言,间隔垫片优选仅由两个构件、即由骨粘固剂或由陶瓷材料构成的大腿部件和由陶瓷材料构成的小腿部件构成且大腿部件具有两个彼此平行布置的滑动面,其被支承在小腿部件上的两个彼此平行布置的拱形结构上。
优选地,为了改善稳定性大腿部件在滑动面之间被封闭。
为了避免转动,小腿部件在与拱形结构相对的底侧上具有垂直突出的榫部,其在横截面上非圆形地成形且优选具有带棱的或椭圆形的横截面。
因此,本发明描述了一种在内置管术中用于感染的临时手术治疗的间隔垫片(Spacer),其一件式或多件式地由一种或多种陶瓷材料与由塑料或金属构成的接口模块组合地构成,必要时额外地部分或完全被涂以抗生有效成分或起抗菌作用的材料。
有利地:
• Spacer的所有裸露面(带有与生物组织的接触的面)被磨光或被另外地处理,带有降低表面粗糙度以便于减少由于细菌引起的生物膜形成和附着的目的。
• 涂层在人体中的时间期间释出一种或多种抗生有效成分,例如以含庆大霉素的棕榈酸盐层的形式,备选地该涂层同样可以起抗生作用的金属(例如银或铜)来实施,其防止细菌定殖,而不强制释出有效成分。
•当释出在层穿过体液的穿透的时间关系中或通过层的分解(生物降解)实现且进而实现由外向内的有效成分释出时,例如通过带有不同有效成分浓度或/或层厚的多个层,有效成分的释出动力可被匹配于患者需求。
可使用的陶瓷材料:
• 高纯度氧化铝、尤其CeramTec公司的Biolox Forte材料
• 氧化锆增强的氧化铝(ZTA)、尤其CeramTec公司的Biolox Delta材料
• 钇稳定的氧化锆(3Y-TZP)、尤其CeramTec公司的MZ111材料
• 铈稳定的氧化锆(Ce-TZP),在其中氧化锆的四方相的稳定通过氧化钇实现。
• 带有例如包含作为分散胶体(Dispersoide)的铝酸锶(Strontiumaluminate)且关于断裂韧性参数达到最高值的第二相的钇稳定的氧化锆。
• 当然,该材料等级的所有变体方案适合用于根据本发明的构件。
• 也将非氧化物的陶瓷材料、例如氮化硅Si3N4考虑作为用于该发明的陶瓷材料。
用于在髋部和肩部内置管术中的应用的实施形式,
- 有利地:
• 该系统模块化地构建且由带有被插上的适配器套和又被插上的球头或者球段头的柄构成。为此参见附图。
• 陶瓷球头原则上等于髋部内置管术的常规球头,然而应用决定地满足关于几何公差和表面品质的较小要求
• 陶瓷球头4的直径在48与60mm的范围中,因为对着经移除的金属盘在髋臼中留下的空腔或者对着自然的髋臼实现连接,如果存在半假体的感染,以6mm的步长的分级在经济上是有意义的,其它的分级显然同样是可行的。
• 球头的连接球体的功能区可小于在髋部假体的情形中常见的(球段)。
• 通过锥形夹紧连接实现在柄与套管之间以及在套管与球头之间的联接,备选地在柄与套管之间的联接还可实施成基于截棱锥几何形状的夹紧连接或形状配合地基于四边形几何形状来实现,以便于例如促进柄通过单轴干压陶瓷粉末的成型,备选地该联接还可材料配合地或者形状配合地在使用在内部手术中待混合的骨粘固剂(必要时包含抗生有效成分例如庆大霉素)的情形下实现。
• 在锥形夹紧连接的情况中通过大于常见髋部假体的圆锥直径实现联接,以便于如此实现较大的柄颈直径,这相比金属柄降低了在陶瓷柄颈中的弯曲应力。
• 套管由所建立的植入物合金例如TiAl6V4、CoCrMo、不锈钢或纯钛构成,备选地套管还可由生物相容的聚合体构成,例如PE、XPE、维生素E-XPE、PEEK、PEKK、PMMA构成。
• 一个系统包括多个套管,其带有不同内径和/或外径,其中然而相应地仅一个可被同时使用(不可组合),其如此使得球头的位置沿着柄颈轴线的改变成为可能(所谓的“颈跳动”或“颈长度”)。
• 由聚合体材料构成的套管不具有纯粹力配合的连接(例如圆锥形的夹紧连接),而是额外地具有一个或多个止挡部,其在夹紧连接中由于与之伴随的相对移动达到预先定义的应力状态的情形中被激活。
• 陶瓷柄具有已知的植入物系统的基本形状,以便于如此更节省骨头地取决于所提取的、被感染的系统(包含现存的骨制支架)或/和紧接着待植入的新系统或修复系统(包含在进一步的过程中的所创造的骨制支架)选择Spacer,在经济的角度的情形下同样可提供减少的形状多样性,其根据所建立的市场导向的系统,在较少多样性的情形中使得较高件数成为可能的单元几何形状备选地也是可能的。
• 陶瓷柄在近侧部分处具有凸缘,其负责额外的支撑且进而不仅有助于柄的沉入且防止向内生长。
备选地,密封的陶瓷涂层可被涂覆到所建立的由金属材料构成的髋部柄上,从而使得柄于是关于表面或者其化学、物理和生物特性与全陶瓷的柄充分类似,从而充分地减少骨整合以及细菌定殖。
附图说明
下面借助附图对本发明作进一步说明。
具体实施方式
图1显示了根据本发明的间隔垫片或者Spacer1,其由带有用于套管3和头部4的伸出的容纳元件13的柄2构成。柄2和头部4由陶瓷构成。在该实施形式中,套管3由金属构成。为了使柄2可被更抗扭地植入在骨头中,其在横截面上具有矩形或椭圆形的形状。
图2仅显示了柄2。在所标明的位置A1处,其具有解剖学设计。在所标明的位置A2处,柄具有较大的半径。在区域A3中在横截面上仅存在较软的过渡。柄在A4的区域中具有14*14的最大横截面。
图3显示了柄2的不同尺寸。图4显示了相比用于包含套管3的Spacer的球头4的常规球头5。球头4大于用于髋部假体的常规球头5。
柄2的表面粗糙度Ra在烧结之后优选为0.25至0.35。Spacer 1的球头4具有优选0.1μm的表面粗糙度。
用于在膝部内置管术中的应用的实施方案:
图5a,5b显示了在膝部关节假体的情形中的现有技术。该假体由陶瓷的大腿部件6、PE部件7和陶瓷的小腿部件8构成。图5a显示了被植入的假体且图5b显示了尚未植入的假体。
在图6和7中显示了用于膝部的根据本发明的Spacer。
图6a显示了由骨粘固剂构成的大腿部件9,其被支承在由陶瓷构成的根据本发明的小腿部件10上。小腿部件10大致由带有拱形结构15的由陶瓷构成的矩形台构成,大腿部件9以其滑动面14支承在该台上。在其底侧处,小腿部件10具有榫部11,其为了抗扭地非圆形地成形,例如具有带棱的或椭圆形的横截面。不仅大腿部件9而且小腿部件10利用骨粘固剂被锚固在骨头中。
在图7a和7b中显示了一种备选的Spacer。在该实施形式中,大腿部件12由陶瓷构成,如同小腿部件10。小腿部件10与根据图6b的小腿部件10相同地构造。
有利地:
• Spacer的大腿部件9,12具有简化的几何形状,根据由PMMA材料构成的现存的Spacer,备选地可实现通用几何形状,其是在市场上最需要的植入物系统的内轮廓的平均或这些系统的重叠的最小几何形状(最小材料条件)
• 小腿部件10以简化的台形式由陶瓷实现,在其处关节缝隙通过一个或多个可堆叠的隔板的插入来实现
• 隔板由陶瓷或低摩擦的聚合体、例如PE、XPE、维生素E-XPE构成,其中,聚合体额外地可被填充以一种或多种在体内被释出的抗生有效成分。
陶瓷部件的制造:
连接的部件可利用已知的制造工艺来生产,例如单轴或均衡的干压、切削成型、单阶段或多阶段的烧结(热均衡的挤压是可行的然而可能是不必要的)、在经烧结的状态中的磨削和磨光,其中,由于对公差和表面品质的较少的要求可减少磨削和磨光处理或者必要时可取消部分步骤。
连接的部件的造型同样可通过陶瓷注塑成型(CIM或LIM)来实现。
在髋部或肩部内置管术的应用的情况中,对于柄2的制造可设想如下方法:
• 注浆成型(Schlickerguss)
• 干压
• 湿压
• CIP(冷均衡挤压 (cold isostatic pressing)) – 按照最终轮廓的冷均衡挤压
• CIM(陶瓷注塑成型(ceramic injection molding))- 陶瓷注塑成型
• 凝胶铸造
• LIM(低压注射成型(low pressure injection molding))
陶瓷柄的表面在烧结之后必要时以如下程度通过磨削或/和滑动磨削或/和磨光被机械后处理,使得形成尽可能光滑的表面,其不或尽可能少地被骨整合到骨头中以及防止细菌定殖,然而必要时使得涂层的充分附着成为可能。
在髋部或肩部内置管术中的应用的情况中,金属套管3有利地节省成本地通过深冲由钢板坯件制成。
Claims (10)
1.用于关节中的感染的临时手术治疗的作为在肩部、膝部和髋部的内置管术中的关节替代物的由各个部件(2,3,4,9,10,12)构成的间隔垫片(“Spacer”)(1),其特征在于,所述间隔垫片(1)由至少一个由一种陶瓷材料或由多种陶瓷材料或由一种带有陶瓷涂层的非陶瓷材料构成的部件构成。
2.根据权利要求1所述的间隔垫片,其特征在于,带有与生物组织的接触的至少一个陶瓷部件的所有暴露的表面被磨光或被处理成,使得其表面粗糙度Ra小于0.35μm。
3.根据权利要求1或2所述的间隔垫片,其特征在于,所述至少一个陶瓷部件至少在部分区域中携带有带有一种或多种抗生有效成分的一个涂层或多个涂层。
4.用于在所述髋部和肩部的内置管术中的关节替代物的根据权利要求1至3中任一项所述的间隔垫片,其特征在于,所述间隔垫片(1)由带有伸出的容纳元件(13)的陶瓷柄(2)构成,在所述容纳元件(13)上固定有金属套管(3)且在所述套管(3)上锚固有陶瓷球头(4)。
5.根据权利要求4所述的间隔垫片,其特征在于,在柄(2)与套管(3)之间以及在套管(3)与球头(4)之间的联接通过锥形的夹紧连接实现或在柄(2)与套管(3)之间的联接基于截棱锥几何形状的夹紧连接或形状配合地基于四边形几何形状来实现,以便于例如促进所述柄(2)通过陶瓷粉末的单轴干压的成型或在使用骨粘固剂的情形下材料配合地或者形状配合地实现所述联接。
6.根据权利要求4所述的间隔垫片,其特征在于,所述套管(3)在所述容纳元件(13)上经由一个或多个止挡部被夹紧。
7.根据权利要求1至6中任一项所述的间隔垫片,其特征在于,所述柄(2)的接合到骨头中的区段在横截面上具有矩形或椭圆形的形状。
8.用于在所述膝部的内置管术中的关节替代物的根据权利要求1至3中任一项所述的间隔垫片,其特征在于,所述间隔垫片仅由两个构件(9,10或10,12)构成,即由骨粘固剂或由陶瓷材料(12)构成的大腿部件(9)和由陶瓷材料构成的小腿部件(10)且所述大腿部件(9,12)具有两个彼此平行布置的滑动面(14),其被支承在所述小腿部件(10)上的两个彼此平行布置的拱形结构(15)上。
9.根据权利要求8所述的间隔垫片,其特征在于,所述大腿部件(9,12)在所述滑动面(14)之间被封闭。
10.根据权利要求8或9所述的间隔垫片,其特征在于,所述小腿部件(10)在与所述拱形结构(15)相对的底侧上具有垂直突出的榫部(11),其在横截面上非圆形地成形且优选具有带棱的或椭圆形的横截面。
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DE102016009730A1 (de) * | 2016-07-28 | 2018-02-01 | Forschungszentrum Jülich GmbH | Verfahren zur Verstärkung von transparenten Keramiken sowie Keramik |
DE102017107621A1 (de) * | 2017-04-10 | 2018-10-11 | Ilias Efthimiou | Reibbelagkörper |
GR20180100146A (el) * | 2018-04-04 | 2019-11-28 | Βλαχος, Ιωαννης Ηλια | Συστημα κεραμικης αρθροπλαστικης επιφανειας |
US20210145549A1 (en) * | 2019-11-14 | 2021-05-20 | Biomet 3I, Llc | Implant placement assist system |
AU2021200566B2 (en) * | 2020-03-20 | 2022-06-02 | Heraeus Medical Gmbh | Device and method for producing spacers |
RU202061U1 (ru) * | 2020-04-09 | 2021-01-28 | Иван Михайлович Ефремов | Форма для изготовления головки монополярного спейсера тазобедренного сустава |
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- 2015-12-03 WO PCT/EP2015/078460 patent/WO2016087561A1/de active Application Filing
- 2015-12-03 BR BR112017010111A patent/BR112017010111A2/pt not_active Application Discontinuation
- 2015-12-03 DE DE102015224150.5A patent/DE102015224150A1/de not_active Withdrawn
- 2015-12-03 US US15/532,914 patent/US20170340445A1/en not_active Abandoned
- 2015-12-03 CN CN201580065814.6A patent/CN107223041A/zh active Pending
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Also Published As
Publication number | Publication date |
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BR112017010111A2 (pt) | 2017-12-26 |
JP2017536214A (ja) | 2017-12-07 |
RU2017123560A (ru) | 2019-01-10 |
DE102015224150A1 (de) | 2016-06-09 |
US20170340445A1 (en) | 2017-11-30 |
EP3226811A1 (de) | 2017-10-11 |
WO2016087561A1 (de) | 2016-06-09 |
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