CN102088931A - 用于治疗假体感染的模块式间隔件装置 - Google Patents

用于治疗假体感染的模块式间隔件装置 Download PDF

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Publication number
CN102088931A
CN102088931A CN2008801303254A CN200880130325A CN102088931A CN 102088931 A CN102088931 A CN 102088931A CN 2008801303254 A CN2008801303254 A CN 2008801303254A CN 200880130325 A CN200880130325 A CN 200880130325A CN 102088931 A CN102088931 A CN 102088931A
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screw
designed
aforementioned
activating agent
drug products
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CN102088931B (zh
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G·法齐奥利
R·索菲亚蒂
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Tecres SpA
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Tecres SpA
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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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3611—Heads or epiphyseal parts of femur
    • A61F2002/3621—Heads or epiphyseal parts of femur pierced with a longitudinal bore
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/365—Connections of heads to necks
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
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Abstract

一种用于两步骤治疗假体感染的间隔件装置(1)，由可生物相容和多孔的材料制造，设计成能够添加药物产品、活性剂和/治疗成分，它包括：第一部分(2)，该第一部分设计成固定在由在先植入件留下的相应骨床上；以及第二部分(3)，该第二部分设计成插入病人的相应关节区域中，第一部分(2)和第二部分(3)通过可调节连接装置(4)来安装。

Description

用于治疗假体感染的模块式间隔件装置
技术领域
本发明涉及一种用于两步骤治疗假体感染的间隔件装置，所述假体为例如臀假体、肱骨假体、膝盖假体、踝假体等。
背景技术
假体感染是最令人害怕的一种假体失效原因。特别对于臀假体，这些感染相当频繁地出现，出现的百分率是在0.5％和6％之间的病例中。在重新植入的情况下或在有危险因素(例如在先外科手术、局部血肿、间发性传染病、局部或总体骨疾病、免疫系统受损等)时感染的百分率增加。
一种治疗感染的、定义为两步骤治疗的方法包括：第一步骤，其中，取出感染的假体，因为仅采用保守的抗生素治疗成功的可能性极其有限；以及第二步骤，其中，一旦从病人组织中消除了所有感染，就植入新假体。
为了保持用于新假体植入所需的空间和为了治愈感染，申请人开发了用于临时使用的专门假体，也称为临时间隔件，它释放药物和/或治疗产品，并能够进行关节运动。
这些间隔件是意大利专利No.IT-1278853和欧洲专利No.EP-1274374的主题，它们都为相同申请人，并被本文参引。
国际专利申请WO-2007/099232介绍了一种临时间隔件，它包括半球形头部，该半球形头部插入相应关节中，且该半球形头部能够与一杆分离和安装在该杆上，以便插入由在先植入件留下的骨床中。利用在WO-2007/099232中所述的间隔件，可以使得杆与不同尺寸的半球形头部组合，以便适应病人关节的解剖结构。在半球形头部和杆之间的连接通过相应截头锥形区域来实现。
发明内容
本发明的一个目的是改进背景技术。
本发明的另一目的是提供一种间隔件装置，它能够很容易地适应不同的病人尺寸。
本发明的还一目的是提供一种间隔件装置，它很容易植入病人体内。
本发明的还一目的是提供一种间隔件装置，它能够保持关节功能，缩短病人恢复时间。
本发明的附加目的是提供一种间隔件装置，它还至少在某些时间期限内支承动态负载，同时等待最后的重新植入。
根据本发明的一个方面，设想了如权利要求1所述的间隔件装置。
附图说明
通过下面对本发明一些实施例的说明将更清楚本发明的其它特征和优点，这些实施例表示为在附图中的实例，附图中：
图1是本发明的间隔件装置的正视图；
图2是图1中所示的间隔件装置的侧视图；
图3是前面附图中所示的间隔件装置的透视放大剖视图；
图4是图3中所示的间隔件装置的侧视放大剖视图；
图5是本发明的间隔件装置的另一形式的透视放大剖视图；
图6是图5中所示的间隔件装置的侧视放大剖视图；
图7是本发明的间隔件装置的另一形式的透视图；以及
图8是图7中所示形式的间隔件装置的侧视放大局部剖视图。
具体实施方式
参考附图，参考标号1表示本发明的整个间隔件装置，特别是用于两步骤治疗假体感染的间隔件装置。
在描述实施例中将特别介绍用于治疗和更换臀假体的间隔件，不过应当知道，本发明也可以用于治疗其它类型的假体，例如肱骨假体、膝盖假体、踝假体等。
本发明的装置1由多孔的可生物相容材料来制造，并设计成能够附加一种或更多种药物产品、活性剂和/或治疗成分，它们释放至该装置附近的病人组织内。
用于本发明的间隔件装置的材料可以从金属、金属合金、有机金属、陶瓷、玻璃和塑料中选择。
更具体地说，塑料可以从热塑性聚合物中选择，例如：丙烯酸树脂，包括所有共聚物和丙烯酸合金：聚乙烯、聚丙烯，通过注射模制或通过吹塑模制而热成形。
在本发明的一个实施例中，材料由骨胶和一种或更多种上述塑料的组合而获得。
本发明的间隔件装置的材料可以已经包括一种或更多种第一药物产品、活性剂和/或治疗成分(例如抗生素)，且为多孔的，与该第一药物产品、活性剂和/或治疗成分相同或不同的一种或更多种药物产品、活性剂和/或治疗成分可以例如通过浸透来添加。
在本发明的另一实施例中，间隔件并不包括药物产品、活性剂和/或治疗成分，且一种或更多种药物产品、活性剂和/或治疗成分在装置植入病人体内时例如通过浸透来添加。
从药物和治疗产品来看，至少三种不同类型的材料可以用于间隔件：
已经包括一种或更多种药物产品、活性剂和/或治疗成分的材料，且并不添加其它药物和/或治疗产品；
已经包括一种或更多种药物产品、活性剂和/或治疗成分的材料，且可能添加了其它药物和/或治疗产品，例如当材料自身为多孔时通过浸透来添加；
并不包括任意药物产品、活性剂和/或治疗成分的材料，且当装置植入病人体内时能够添加一种或更多种药物产品、活性剂和/或治疗成分，例如当材料自身为多孔时通过浸透来添加。
药物产品、活性剂和/或治疗成分可以包括抗生素、防腐剂、抗麻醉药、化学治疗药物(例如庆大霉素、万古霉素等)或者其它活性成分。
根据附图，装置1包括：第一部分2，该第一部分2设计成固定在由在先植入件留下的相应骨床上；第二部分3，该第二部分3设计成插入病人体内的相应关节区域中，该第一部分2和第二部分3通过可调节类型的连接装置4来连接。装置还包括阻塞装置5，该阻塞装置5设计成固定可调节连接装置4的位置。
在附图所示的实施例中(该实施例涉及臀关节)，第一部分2包括杆6，该杆将被插入股骨的近侧部分中。
根据图1和2中特别所示，杆6包括两个相当长和细的部分7、8，该部分7、8设计成将插入股骨的、在解剖学上较长和细的相应部分中。当股骨更粗和更短时，可以使用更宽和更短的杆6，如图8中所示。
杆6还包括更宽的部分9；不过，如图7和8中所示，可以没有该更宽部分9，且杆6可以有大体上截头锥形形状，以便保持股骨的转节(当它仍然处于良好状态时)。
还有，在图中所示的实施例中，第二部分3包括大体上半球形头部10，特别是根据图2，可以预计有不同尺寸的头部11、12，特别是有不同直径的半球，以便适应病人关节囊的不同尺寸。
因此，应当知道，可以选择不同尺寸的杆6，也就是说杆有不同尺寸和截面以及不同尺寸的头部10-12，以便更好地适应病人的解剖结构。
本发明的间隔件装置的重要特征在于其包括可调节连接装置4，该可调节连接装置4除了连接第一部分2和第二部分3，还可以用于调节在第一部分2和第二部分3之间的相互位置。在图中所示的实施例中，由于可调节连接装置4的作用，可以改变间隔件装置1的颈部13的长度“D”，还用于更好地适应植入该间隔件装置的病人的解剖结构。
根据本发明的一种形式，可调节连接装置4包括螺钉/螺母连接件14-15，但是在不脱离本发明范围的情况下也可以使用其它类型的可调节连接件。
该特征构成了绝对新颖性，因为它使得医师能够治疗控制关节头部的分离。实际上，通过转动半球形头部，可以伸长或缩短装置的颈部，从而使得医师能够获得理想的关节头部分离，用于更合适地施加最后假体。
换句话说，当植入间隔件装置时，医师可以确定颈部的最合适长度“D”，以便使得关节头部保持正确的分开距离，用于随后施加最后假体。
在图1-4和7、8所示的形式中，螺钉14由杆6支承，而螺母15位于头部10中。在图5和6的形式中，螺母15位于杆6上，而螺钉14安装在头部10上。
本发明的间隔件装置的另一重要特征在于其包括阻塞装置5，根据图1-6所示的实施例，该阻塞装置5包括自硬化液体胶泥，该自硬化液体胶泥设计成固定在第一部分2和第二部分3之间的相互位置。
特别是，前述胶泥防止在两个部分2和3之间(也就是说头部10-12和杆6之间)的相互旋转。
胶泥可以与专用预负载注射器一起以一套工具的形式来提供，该胶泥通过孔或槽道16注入，根据本发明的实施例，该孔或槽道16可以位于头部10-12上或杆6上。
在图7和8所示的形式中，阻塞装置5包括：位于螺钉14中的一系列槽17，这些槽17与螺钉14自身的轴线平行；以及钉18或螺钉，用于插入螺钉14中的专门轴向孔19中。
一旦调节了在头部10-12和杆6之间的位置，钉18插入螺钉14的孔19中，且由于存在槽17的原因，螺钉14膨胀，并阻塞在螺母15内部。
上述本发明可以进行多种变化和改变，所有这些变化和改变都在本发明的保护范围内。

Claims (21)

1.一种用于两步骤治疗假体感染的间隔件装置(1)，由可生物相容的材料制造，设计成能够添加药物产品、活性剂和/治疗成分，它包括：第一部分(2)，该第一部分设计成固定在相应骨床上；第二部分(3)，该第二部分设计成插入病人的相应关节区域中，所述第一部分(2)和所述第二部分(3)通过连接装置(4)来连接，其特征在于：所述连接装置(4)是能够调节的，这样，所述连接装置能够调节所述第一部分(2)和所述第二部分(3)之间的相互位置。
2.根据权利要求1所述的装置，还包括：阻塞装置(5)，该阻塞装置设计成阻塞可调节连接装置(4)的位置，从而阻塞第一和第二部分之间的相互位置。
3.根据权利要求1或2所述的装置，其中：所述第一部分(2)包括待插入股骨的近侧部分中的杆(6)。
4.根据权利要求3所述的装置，其中：所述杆(6)能够具有不同的长度和截面，以便用于适应病人股骨的不同尺寸。
5.根据前述任意一个权利要求所述的装置，其中：所述第二部分(3)包括基本半球形头部(10-12)，所述头部预计为多种尺寸，特别是有不同直径的半球，以便适应病人的关节囊的不同尺寸。
6.根据前述任意一个权利要求所述的装置，还包括：在所述第一和第二部分(2、3)之间的颈部(13)，该颈部有长度“D”，所述可调节连接装置(4)使得所述颈部(13)的所述长度“D”能够改变。
7.根据前述任意一个权利要求所述的装置，其中：所述可调节连接装置(4)包括螺钉/螺母连接件(14、15)。
8.根据权利要求7所述的装置，其中：所述螺钉(14)安装在第一部分(2)上，所述螺母(15)位于第二部分(3)上。
9.根据权利要求7所述的装置，其中：所述螺母(15)安装在第一部分(2)上，所述螺钉(14)位于第二部分(3)上。
10.根据权利要求2至9中任意一个所述的装置，其中：所述阻塞装置(5)包括胶泥，该胶泥设计成阻塞第一部分(2)和第二部分(3)之间的相互位置。
11.根据权利要求10所述的装置，其中：所述胶泥通过位于所述第一部分(2)中或所述第二部分(3)中的孔或槽道(16)来注入。
12.根据权利要求2至9中任意一个所述的装置，其中，所述阻塞装置(5)包括：一系列槽(17)，这些槽位于螺钉(14)中，与螺钉(14)自身的轴线平行；以及钉(18)或螺钉，用于插入位于螺钉(14)中的孔(19)内，所述钉(18)设计成使得所述螺钉(14)膨胀，并使它阻塞在螺母(15)内。
13.根据前述任意一个权利要求所述的装置，其中：所述第一部分(2)包括杆(6)，该杆为基本截头锥形形状，以便保持必须植入所述杆(6)的股骨的转节。
14.根据前述任意一个权利要求所述的装置，其中：所述可生物相容的材料包括一种或更多种第一药物产品、活性剂和/或治疗成分，它们设计成释放至装置附近的病人组织中。
15.根据权利要求1至13中任意一个所述的装置，其中：所述可生物相容的材料没有添加药物产品、活性剂和/或治疗成分。
16.根据权利要求14或15所述的装置，其中：所述可生物相容的材料为多孔的，并可以有添加的一种或更多种药物产品、活性剂和/或治疗成分，该药物产品、活性剂和/或治疗成分与第一药物产品、活性剂和/或治疗成分相同或不同。
17.根据前述任意一个权利要求所述的装置，其中：所述药物产品、活性剂和/或治疗成分包括以下产品中的一种或更多种：抗生素例如庆大霉素、万古霉素；防腐剂；抗麻醉药；化学治疗药物等或者其它活性成分。
18.根据前述任意一个权利要求所述的装置，其中：所述可生物相容材料包括从金属、金属合金、有机金属、陶瓷、玻璃、塑料中选择的材料。
19.根据权利要求1至17中任意一个所述的装置，其中：所述可生物相容材料包括从热塑性聚合物、丙烯酸树脂、聚乙烯、聚丙烯中选择的塑料，该丙烯酸树脂包括所有共聚物和丙烯酸合金。
20.根据权利要求19所述的装置，其中：所述塑料通过注射模制或通过吹塑模制来热成形。
21.一种装置，其中，所述可生物相容材料包括骨胶与根据前述权利要求18至20中任意一个所述的一种或多种材料的组合。
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