CN101060815A - 具有传感器的整形外科用植入物 - Google Patents

具有传感器的整形外科用植入物 Download PDF

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Publication number
CN101060815A
CN101060815A CNA2005800267685A CN200580026768A CN101060815A CN 101060815 A CN101060815 A CN 101060815A CN A2005800267685 A CNA2005800267685 A CN A2005800267685A CN 200580026768 A CN200580026768 A CN 200580026768A CN 101060815 A CN101060815 A CN 101060815A
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China
Prior art keywords
implant
pick
microchip
bone
hone lamella
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CNA2005800267685A
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CN101060815B (zh
Inventor
查德·莫根
哈利·T·霍尔四世
詹姆士·M·格林
杰弗里·弗莱瑟纳
查尔斯·E·盖尔兹
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Synthes GmbH
HFSC Co
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HFSC Co
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  • Prostheses (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

本发明涉及用于固定骨的整形外科用植入物，如骨板，其中该植入物具有至少一个微芯片和至少一个与该微芯片连接的传感器。该传感器被构造成接收来自植入物的一部分或病人组织的物理刺激，如温度、压力和形变。该传感器收到的信息由微芯片收集并发送到病人体外的接受设备，如个人计算机上。该信息可以使医生诊断出该植入物的使用寿命，该骨板的载荷以及与整形外科植入物有关的可能并发症，如感染、骨折不愈合和疲劳。该植入物也可具有一个或多个位于其表面上的电极，该电极发出电流以刺激折断或折裂的骨愈合。

Description

具有传感器的整形外科用植入物
相关的申请数据
本发明要求2004年6月7日提交的第60/578,107号美国临时专利申请的优先权。
技术领域
本发明涉及整形外科所用的植入物，如骨板，以用于修复折裂的骨或用于其它的整形外科情况。具体地，本发明涉及一种具有传感器和/或微芯片的整形外科用植入物，该传感器和/或微芯片用于测量与植入物和/或周围组织有关的数据并将其传送给医生和/或病人。
背景技术
采用骨板来修复断骨在整形外科领域已运用多年并且在本技术领域已是众所周知的技术。授予Weaver等人的美国专利6,623,486中示出和描述了这种骨板的一个例子，该专利在此引为参考。这种骨板在大多数情况下起到了良好的作用，并且骨折愈合效果比不使用骨板时好。然而，在某些情况下，不恰当的安装、植入物失效、感染或其它诸如病人对规定的手术后治疗不配合等情况都可能会对骨裂的愈合产生不利影响，并且可能增加对病人健康的威胁。目前健康护理专家采用非侵入的方法，如X射线来检查骨折愈合进展并且评价被植入的骨板的情况。但是，依靠X射线不足以作出准确的诊断，它们价格较高，而且重复的X射线会损坏病人和健康护理人员的健康。在某些情况下，直至骨板失效都可能未在临床上检测到骨折不愈合。而且，X射线也不足以用于对软组织或植入物上的应力作出诊断。在某些情况下，为了采取适当的补救措施，需要侵入式操作以尽早诊断植入物故障或感染。
因此，需要一种整形外科用植入物，不需要X射线或侵入式操作，该植入物就可向医生和病人提供有关植入物状况、骨折愈合进展、周围组织状况的准确和正确信息。
发明内容
本发明包括用于固定骨的整形外科用植入物，例如骨板、髓内钉等，该植入物具有一个或多个微芯片(例如，集成电路)和多种用于收集与植入物和其周围情况有关的信息的传感器。
所提供的植入物包括构造成与病人的组织接触的本体部、一个或多个微芯片和多个置于该植入物本体上且与所述微芯片连接的传感器，其中至少一个传感器构造成接收来自该植入物的一部分或病人组织的物理刺激。该微芯片还可以包括数据记录装置和例如电池的电源。
所述植入物可以是骨板、骨钉、髓内钉、脊柱固定元件(椎弓根螺钉、椎弓根钩、固定板、固定杆等)、椎间植入物(人工椎间盘或融合隔离件)、牵引器、外部固定系统或其它整形外科用植入物。该植入物可具有涂层，该涂层可以包括聚合物或多孔金属，可用作药物活性试剂或其它治疗物质的载体或底物。该植入物还可包括用于贮存治疗性试剂的腔室，该治疗性试剂如抗生素、生长因子、化疗试剂等。该治疗性试剂可响应微芯片所接收的信号而释放。
所述植入物上的一个或多个传感器可以构造成适于接收该植入物的至少一部分的形变。该传感器可构造成适于接收施加在该植入物的至少一部分上的压力，和/或接收该植入物的至少一部分上的温度。该传感器也可构造成捕获病人组织周围的数字图像(影像和/或图像)。该传感器也可构造成适于发出刺激骨生长的电流。
所述病人组织可包括折裂的第一骨部分和第二骨部分，所述植入物还可包括构造成向该第一骨和第二骨的末端施加微动而促进该折裂部分融合的元件。
所述植入物还可包括用于对施加到该植入物上的加载周期进行计数的计数器。
在另一个实施例中，用于固定骨的植入物包括：多个用于容纳固定件的孔；板载(onboard)微芯片，该微芯片包括数据记录装置、信号调节器、多路转接器(multiplexer)和发送器；和多个与所述微芯片连接且设置在该植入物的多个位置上的传感器，其中所述传感器构造成接收该植入物的一部分上的至少一个物理刺激。
所述传感器的一个可以选自下列的至少一个：压力变换器、热偶、变形测量器和周期计数器。
在另一实施方案中，本发明涉及修复断骨的方法，该方法包括：提供具有微芯片的骨固定植入物，将多个传感器设置在所述植入物上，将所述多个传感器与所述微芯片连接，用多个固定件将该植入物固定到所述断骨的第一和第二部分上，将所述传感器的数据提供给所述微芯片，和将所述微芯片的数据发送给外部接收设备。
在另一实施方案中，提供了监测系统，其包括：植入物，其具有至少一个传感器且构造成可至少部分地插入到病人体内；与该植入物和传感器连接的微芯片，其构造成接收来自所述传感器的至少第一信号；与所述微芯片连接以发送代表所述第一个信号的第二信号的发送器；位于病人体外的接收器，其构造成接收所述发送的第二信号；与所述接收器连接的显示设备，其构造成向使用者提供代表所述第二信号的声音或可视信息。该显示设备还可构造成连续地记录所述发送的第二信号。
所述植入物可以具有涂层。这种涂层可包括聚合物或多孔金属，如镁，其可以作为药学活性试剂或合成试剂的载体或底物。
附图说明
为便于理解和阐述本发明，附图中公开了例举的和优选的特征和实施方案，然而可以理解，本发明并不仅限于所示的这些具体的设置和装置。其中，多幅图中相同的标号表示类似的部件，且其中：
图1是本发明的骨板的第一实施方案的立体图；
图2是与骨结合的本发明的骨板的第二实施方案的侧视图；
图3是本发明的骨板的实施方案的底面立体图；
图4是多种微芯片元件的实施方案的方框图；
图5是与骨结合的本发明的骨板的横截面图；
图6是本发明的优选实施方案的髓内钉的立体图；
图7是本发明的另一优选实施方案的椎弓根螺钉的立体图；
图8是本发明的又一优选实施方案的椎弓根钩的立体图；
图9是本发明的又一优选实施方案的椎骨间植入物的侧视图；
图10是本发明的一优选实施方案的上颌面牵引器的立体图；
图11是本发明的一优选实施方案的外部骨固定系统的侧视图。
优选实施方案的详细描述
现参见图1-2，图中示出了本发明第一优选实施方案的骨板10。图1所示的骨板10包括上表面15和下表面20，该下表面20被构造成与骨接触。该骨板还可以具有多个孔30，该孔30被构造成适于容纳将该骨板固定到骨上的固定件，如螺钉。一个或多个微芯片40可以位于该骨板的上表面15、下表面20、骨板侧壁上，或者如图示的实施方案置于该骨板上的腔室45中，以记录由多个传感器50收集的信息。这些传感器可以置于该骨板的上部、下部或侧面的任何位置，或者可以围绕该骨板上的孔或位于该孔中。该传感器可以位于该骨板的表面，或嵌入其中。小盖子60可提供来隐藏和保护该骨板中的微芯片40。该盖子60可以密封该微芯片以避免其暴露在该骨板所处的环境中。或者，微芯片40可以不被覆盖而完全地露出在外。虽然参考具有图1所示结构的骨板，可以注意到，可以将一个或多个微芯片40和传感器50与本领域公知的任何适当固定装置，如髓内钉、用于外部或内部固定的螺钉、脊柱固定元件(椎弓根螺钉、钩、固定杆等)、椎骨间植入物(人工椎间盘和隔离件)、用于加长骨和矫正变形的牵引器等联合使用。而且，应当强调，对于单个固定装置可以使用多个微芯片40和/或多个传感器50以监测该固定装置的不同区段或监测所述骨板上设置的不同类型传感器(例如形变、压力、温度、周期计数)。进一步地，位于一个植入物10中的微芯片40可以向其它植入物输送数据和从其它植入物接收数据。例如，位于一骨折位置的骨板10可以向位于同一块骨或不同骨中的不同骨折位置的另一骨板10传送数据。类似地，在一位置上的椎弓根螺钉可以接收来自其它椎弓根螺钉、钩或固定杆上的数据。本发明的植入物也可以用于潜在的病理学骨折位置，此时，有关植入物上形变增加的信息会显示受影响骨正在变弱。类似地，这些植入物也可应用于已进行过骨切开术或切除术的位置以监测骨强度。
此外，所述骨板10上的孔30是螺纹的，以接收具有螺纹头的螺钉，如授予Talos的美国专利5,709,686所述，该专利在此引为参考。该螺钉和骨板之间的螺纹连接可以将该螺钉和骨板锁定在一起，从而使该螺钉即使在其杆在周围的骨上失去支撑时也不会从该骨板上退出，这在由于骨切开术或其它原因导致病人的骨结构不标准的情况下是需要的。不具有这种板锁定特征的标准压紧螺钉在安装后加载过程中受到所述板上产生的弯曲作用力时可能会从所述不标准骨中拉出。此外，标准压紧螺钉都被设计成与所述板的螺钉孔以这种方式接合以促进愈合：将所述折裂的骨末端压迫在一起。因此，在仅具有压紧螺钉的骨板跨过骨折部位安装时，所述骨部分在固定后的过程中可能会稍微移动。因此，在此过程中所测得的骨板形变可能不能真实地反映所述骨的真实负载能力(例如，可能会异常高)。因而，来自仅采用压紧螺钉的骨板上的传感器的形变读数就可能不能为外科医生提供有关骨早期愈合(例如在植入后数天或第一周内)的可靠信息，而他或她需要根据这些信息做出骨折是否适当愈合的诊断。只有折裂的骨部分已经稳定了，形变读数才会足够准确，才可能做出正确的诊断。相反，当采用锁定螺钉(例如，那些具有可与所述骨板的孔螺纹连结的螺纹头的螺钉)时，则不存在稳定过程，因而所述骨板上观察到的形变值可直接表示植入时该骨板所承受的负荷(并且与所述骨所承受的负荷对应)。因此，外科医生可以采用这些早期测得的形变读数来对骨折愈合速度和不愈合的可能性作出准确和早期的评价。延迟愈合的早期诊断是有利的，因为这可使外科医生在怀疑不愈合时尽可能快地采用补救措施，因而有助于干预。
图2示出了安装在骨上的本发明的可选实施方案。图2示出了通过若干螺钉90而与骨80结合的骨板10。该骨板10可具有弧形、喇叭形或弯曲的截面。所述微芯片的盖子60可保护和盖住一个或多个微芯片40。还可以看到环绕该骨板的不同部分的各个传感器50。
图3示出了所述骨板10的实施方案的底部，显示了孔30和传感器50。在所述骨板与所述骨结合的表面，可以具有一个或多个刺激骨生长的电极70。还可以有小开口65，以便各个传感器电极进入所述骨板中并与其中所包含的所述微芯片连接。开口65还可容纳药学活性试剂，如抗生素、化疗试剂、止痛药和/或其它治疗性试剂的大药丸。所述试剂可以响应治疗医师或病人传达的信号而从所述植入物中释放，或者可以在一个或多个传感器50记录到温度升高或需要该试剂的其它数据信号时由该植入物自动地分配。在一实施方案中，该试剂可以包括生长因子，如骨形态发生蛋白(BMP)或血管内皮生长因子(VEGF)。在其它病理学应用中，该试剂可以包括血管生成抑制剂，如fibulin-5，其具有剥夺肿瘤营养和氧气的作用。在其它重建性应用中，所述药物活性试剂可包括具有在头皮区域刺激头发生长能力的药物，如Minoxidil。传感器50可包括沿所述骨板的底部设置的压力传感器，且可用于测量该骨板对其下方骨的压力(以下将结合图5作进一步描述)。
如图4所示，所述植入物可包含微芯片100，该微芯片可包括数据记录装置140、信号调节器110、多路转接器(multiplexer)120和发送器130。该微芯片可以与一个或多个结合在所述植入物的不同位置的传感器50连接。该传感器可用于通过测量各个位置的形变来监测该植入物的负荷并且计数加载和未加载的周期。或者，该传感器可被构造成即刻测量所述植入物周围的情况，如温度、pH值等。传感器50和/或微芯片40还可包括数字照相性能，如CMOS芯片，其能捕获和传送所述植入物附近的病人组织图像或影像。
图5是与骨80结合的本发明的骨板10的一实施方案的横截面图。此图示出了该骨板10呈半弧形但与该骨80具有不同的曲率，从而使该骨板仅沿其边缘或导轨与该骨接触。这种接触有利于最小化对流向该骨的血流的干扰，如授予Tepic的美国专利第6,309,393号所述，其在此引为参考。因而，置于该骨板边缘或导轨和骨表面之间的传感器50可检测该骨和骨板之间那些传感器位置上的压缩力。所获得的初始力测量值可用来提供移植后该骨板与骨之间的接合的基准值。然后，接下来的测量值可以与基准测量值比较以确定该骨板是否与骨保持充分接合或是否需要补救措施(例如，该骨板或螺钉需要更换)。理想的固定情况是：该骨板和骨之间的压缩力从安装所述植入物到将其取出这段时间内都是恒定的。当将多个独立的传感器沿所述骨板的导轨安装时，与各个传感器有关的随后读数可用于独立地识别所述骨板中的各个螺钉的状况，且还可用于获取该骨和骨板之间连接的整体性情况。
因而，设置在所述植入物上的各种传感器可以包括热偶、压力变换器、压力探针、计数器、变形测量器以及数字成像装置。至少一个传感器可用于对该植入物所经历的负荷周期进行计数，包括轴向、弯曲和扭转负荷周期。从这些传感器收集到的信息可用于诊断与该植入物和/或该植入物周围组织有关的状况。
例如，监测所述植入物上各个位置的形变是重要的，因为这种形变可能与该植入物被施加和经受的作用力直接相关。监测施加在该植入物，例如骨板上的作用力一段时间可以使医生能够确定骨是否以适当的速度愈合。随着骨的愈合，该骨所承受的负荷量会增加，所述植入物所承受的负载会按比例降低，因而安装在该植入物上的变形测量器测得的形变会降低。如果所测得的骨板负荷没有以预期的速度降低，那么医生可采取补救措施。类似地，对骨板内的过载情况进行早期检测可使医生能够修正或替换过度形变的或疲劳的骨板或固定件。已经发现，在骨折发生六个月后在临床上可以诊断出所述未愈合。如果变形测量器没有检测到负荷状况的变化，那么就意味着延迟愈合，且可能表明对所述植入物或其使用寿命限度有潜在危险。
也可用一个或多个传感器来监测所述植入物所经历的负荷周期，如轴向、弯曲和扭转负荷周期的数量。一个周期可以定义为向所述植入物施加压力，接着释放该压力。例如，如果植入物沿着病人的股骨安装，则一个周期是一步，即病人在他或她的脚接触地面时向所述植入物施加压力，接着在他或她的脚从地面抬起时释放该压力。植入物的寿命通常由骨愈合或植入物失效之前该植入物所经历的周期数来确定。通过使用编程以记录所述植入物已经经过的周期数量的计数器，医生可以确定该植入物在何时需要更换。另外，这种计数器可以用来确定植入物失效的原因，例如病人过度活动或临床上骨折未愈合。
获得所述植入物上各个位置的温度读数也是需要的，以用于确定植入物周围的组织是否在移植之后受到感染。正常健康的人类组织的温度在约36摄氏度至约37.5摄氏度范围内。已经发现，受到感染的组织可能具有温度升高到约38摄氏度以上的迹象。因此，如果植入物上的一个或多个温度传感器检测到温度升高，那么医生可以进行选择起动抗生素治疗方案，或者采用其它更加侵入式的措施来消除感染。在一实施例中，如上所述，治疗医师可向植入物发送信号以释放储存在该植入物腔室中的抗生素药丸以治疗感染，或者可选择地，可以将该植入物本身构造成当达到某一温度阈值时自动地释放抗生素。所述植入物周围组织的温度异常高还可能是病人正在经历植入物材料的副作用的信号。例如，如果所述植入物是由病人过敏性材料(例如，铬)或含有这种材料的原料制成的，那么该病人的身体对该植入物可能会产生与感染类似的反应。因而，通过温度测定同样可以确定病人对植入物的排斥。植入物中传感器50内的数字照相元件也可用于显示病人组织感染和/或植入物排斥症状的图像。
由于身体的温度会受到多种因素，如运动的影响，因此温度最好是在医生的办公室或其它受控环境中读数，而不是持续地监测或由病人监测。优选地，除了置于骨板和骨之间，所述温度传感器可置于骨板表面的任意位置。因此，通过安装在骨板上的传感器监测温度可以帮助医生对感染作出重要的早期诊断，从而增加有效控制感染的机会。在其它实施方案中，植入物10上的传感器50可以检测病人的周围组织中存在的和形成的化学试剂/反应物。
现参考图4，其是本发明的植入物中所包含的微芯片的方框图。在一实施方案中，该微芯片100可包括用来存储传感器所记录的信息的数据记录装置140。该微芯片还可以包括：信号调节器110，其为所述传感器提供能量并产生该传感器所接收的信号；多路转接器(multiplexer)120，其用于将接受自大量传感器的信息组合；和发送器130，其用于传送接受自一个或多个传感器的信息。当一个或多个传感器50接收到信息时，该信息通过所述信号调节器110传送到多路转接器(multiplexer)120上，并传送到数据记录装置140和无线发送器130上，该数据记录装置140将信息存储在微芯片100上的存储器150中，该无线发送器130将信息传送到与计算机170连接的接收设备160中。装置160可将数据传送到微芯片100并从其上接收数据。此外，可选择地，在又一实施方案中，无线发送器130可用硬线连接方式代替。
在一实施方案中，所述接收设备是无线手提计算机，如Pocket PC、Palm Pilot、Blackberry设备或便携式电话，其可用于请求所述植入物的信息、存储该植入物所发出的信息和将信息发送到该植入物。例如，外科医生可以使该手提设备通过病人身体包含所述植入物的部分，该设备可以上传来自该植入物上的一个或多个传感器的形变、温度、pH和/或压力数据。随后，与微芯片100、传感器50和/或手提设备160相联的软件可以处理该上传的数据而向外科医生提供可视的读出信息。这种读出信息可包括各传感器所获取的离散的作用力、温度、压力和应力周期值。该读出信息还可以包括一段时间内从同一病人处获得的数值图表。它还可以提供警示特征，即发出危险状况信号，如实质性植入物过载、植入物和骨间压力的实质性损失、表示感染的高温状况、和/或表示病人未参与规定的恢复性治疗或者正在对他或她自已实施大于规定量的恢复性治疗的异常低或高的周期负载计数的信号。在一实施方案中，所述软件可以显示特定植入物的图像和在该植入物上的传感器的实际位置上或附近测得的作用力、压力和温度读数。此外，代替与各个传感器有关的离散的数字读出信息，该图像可以简单地是代码色以表示满意或不满意(例如警示)的状况。所以，在一举例性实施方案中，将正在经历预期形变、压力、pH、时间、周期计数和温度值的所述骨板部分表现为蓝色，而将正在经历比预期值更高值的其它部分表现为红色。临界正常值和高形变、温度、压力和周期值可以编程到植入物上的微芯片中，或者由外科医生用手提设备来选择或从其它与植入物相连的计算机中选择。然后，外科医生使用指示笔在显示屏上选择所需的植入物部分，具体的负荷、压力、周期计数、时间和/或温度数据得到显示以反映植入物受影响的区域(例如，红色)。在另一实施方案中，所述接收设备可包括外部诊断仪器，如CT扫描仪，它可将数据传送到植入物10和/或其它手提设备160上并从其上接收数据。植入物10和/或装置160之间的通讯方法可包括红外线通讯。
在一实施方案中，所述微芯片100和数据记录装置140可以包含制造商所提供的植入物特定信息，如植入物的类型、传感器类型、植入物/传感器制造日期、地点、批次等。用于各个传感器的校准数据也可以包含其中。另外，该微芯片100和数据记录装置140可以包含来自与植入物相连的所有传感器的历史读数。该微芯片100还可以被编程对来自传感器的数据进行处理。因而，在一实施方案中，所述手提设备可对数据进行最小限度的处理，或者可以仅显示那些已由微芯片100处理过的且由数据记录装置140存储的数据。可选择地，该手提设备还可用于进行某些数据处理。
随后，医生可将来自所述手提设备的信息传送到台式计算机或网络服务器上以便长期储存或根据需要作进一步处理。在一实施方案中，数据可以匿名地通过因特网或以其它安全传送方式保密地传送给制造商(以保护病人的隐私)。然后，该制造商可使用这种数据以协助设计将来的植入物。所述植入物10和传送/接收设备160还可以构造成人造卫星通讯方式。
在一实施方案中，所述微芯片可以编程为以预定的时间间隔打开和关闭以仅在一天中的某些时间传送信息。在该微芯片是由电池供能时，这种设置是有利的，因而可以用于保存电池电能。可选择地，该微芯片可够造成在植入物的使用寿命过程中连续地传送数据。这在将计算机用来连续地收集信息以用不同变量制备图表时是有利的，该变量如温度、形变、负荷和疲劳度、以及这些变量在一天内是如何改变的，包括病人的活动如何影响变量以及这些变量是否以及如何影响植入物。
如前所述，存储在数据记录装置140中的所述信息可采用无线(例如无线电频率(RF)、红外线等)发送器130传送到人体外的接收设备160中。该无线接收设备可以与手提设备或个人计算机170连接，从而使病人和/或外科医生可以看到所述骨板所传送的信息或者可以将该信息通过因特网传送给接受者进行分析。在一可选的实施方案中，植入物10所存储的数据可采用硬线连接方式传送到人体外的接收设备160上。
可选择地，安装有所述植入物的病人在其家中或办公室中可以具有接收设备。所述微芯片可构造成在某些状况发生时无线地传送信号给该接收设备。例如，在所述微芯片感应到温度上升超过预定温度时，它就发送警示信号到基站，然后该基站会向使用者发送声音警示信号。同样地，基于过度形变、过度压力或过多周期的状况的类似警示也可发生。无线基站所接收的警示信号也可以由该基站自动地通过因特网传送给医生，该医生可以利用即时指令与病人联系。
在一实施方案中，所述微芯片可采用感应原理提供能量。在此实施方案中，将一线圈与所述植入物内的微芯片连接，一线圈嵌在病人体外的读取装置上。病人体外的线圈中的磁动势会在植入物内的线圈中产生磁动势。可用远程能量源，如超声波装置来激发感应线圈。这种设置可如互感器一样操作来为微芯片供能，因而可避免使用电池。
在另一实施方案中，所述植入物可使用压电晶体，该压电晶体会利用所述骨板的加载和未加载周期来产生电压而向该骨板供能。
在又一实施方案中，所述微芯片可采用压电技术以在所述植入物中产生微动。这种微动可传送到骨上而促进该骨愈合。可选择地，正在愈合的骨的固有微动可用于向所述微芯片供能。因而，可采用压电晶体来接收该微动并且将其转换成可对所述设备供能的电荷。
再参考图2，图中示出了所述传感器在骨板10上的具体位置。在此实施方案中，该传感器50位于所述螺孔的周围以向医生或病人提供有关螺钉位置和由各个螺钉作用在所述骨板上的压力的信息。然而，本领域的普通技术人员应该认识到，这种小尺寸的传感器可以位于该骨板上的任何部分，因而可用于提供与所述骨板段有关的物理性能信息和/或与各骨板段有关的周围环境信息。
在另一实施方案中，可以采用所述微芯片，通过位于所述骨板不同位置上的电极70来传送电流以电刺激所述骨的生长。这种刺激可加速骨的生长和恢复，这种现象是本领域公知的。在授予Ahrens等人的美国专利6,663,634中描述了用电流来刺激植入物中的骨生长和增加与骨板一起使用的抗菌试剂的抗感染能力的例子，该专利在此引为参考。
在再一实施方案中，所述骨板至少一部分可具有涂层，其中所述涂层可包括聚合物或多孔金属，如镁，其可用作药物活性试剂或合成试剂的载体或底物。这种试剂可包括抗生素、杀菌剂、生长因子(BMP和/或VEGF)、血管生成抑制剂(fibulin-5)或化疗试剂。该涂层可以是在病人体内可生物分解的。在Schmidmaier等人2001年3月9日提交的美国专利申请09/801,752中详细描述了涂层的非限制性实例，该专利在此引为参考。
在一实施方案中，所述微芯片可通过本领域公知的无线电频率(RF)无线传送信息。所述骨板也可用信息编码，该信息如该骨板何时安装的、谁安装的，从而使得医生可以采用无线电频率识别方式(RFID)从该骨板获得此信息。
虽然本文以与移植的骨板结合的方式示出和描述了本发明，但是本领域的普通技术人员应该认识到，本发明还可以用其它类型的整形外科植入物，如骨钉、髓内杆、脊柱固定元件和植入物(如椎弓根螺钉、钩等)、外部固定件和牵引器来实施。在授予Siddiqui的美国专利6,306,140中示出和描述这种骨钉的一个例子，该专利在此引为参考。Siddiqui描述了插入到骨中的骨钉，其适于固定折裂骨。该骨钉有螺纹并且可提供压力来稳定骨的不同区域。微芯片可以安装在该骨钉中，并且一个或多个传感器位于该骨钉上的不同位置以监测应力、形变、温度和压力。图7示出了椎弓根螺钉210，其具有螺纹212和用于与固定杆216连接的上部214。椎弓根螺钉210包括一个或多个微芯片40和传感器50，它们如上文参考植入物10所述发挥作用。
Ahrens等人的美国专利6,663,634中示出和描述了可用于与本发明结合的骨销的实施方案。Ahrens公开了插入到骨中的骨销，其用抗菌剂涂布。通过在骨销中安装微芯片和在该骨销上安装一个或多个传感器，如Ahrens所述的骨销可用于实施本发明。
如图6所示，本发明也可以以类似的方式结合髓内钉200来实施，该髓内钉具有一个或多个容纳锁定元件和/或横向构件的开口202、204。髓内钉包括一个或多个微芯片40和传感器50，以用于收集和传送与所述植入物和/或周围的患者组织有关的数据。与髓内钉200一起使用的横向构件(未示出)可穿过上开口202并且在修复股骨骨折时可以刺穿股骨头，该横向构件还可包括一个或多个微芯片40和传感器50。在授予Frigg的美国专利6,607,531中示出和描述了髓内钉的另一实例，该专利在此引为参考。
如上所述，本发明还可以结合脊柱固定装置，如椎弓根螺钉210(图7)、椎弓根钩220(图8)和固定杆216、222(图7和8)来实施，该脊柱固定装置插入到脊柱中和/或与其连接。根据本发明，该椎弓根螺钉210、椎弓根钩220和/或固定杆216、222可包括一个或多个微芯片40和一个或多个传感器50以用于如上文所述收集和传送形变、温度、压力和周期的数据。在授予Frigg的美国专利6,325,802和授予Kumar等人的美国专利6,610,063中示出和描述了其它椎弓根螺钉和脊柱固定装置，这两篇专利在此都引为参考。
本发明还可以结合椎骨间植入物来实施，如在融合和非融合手术中用于代替受损的椎间盘的人工椎间盘或隔离件。图9示出了插入到脊柱的两相邻椎骨间的人工椎间盘230。人工椎间盘230包括一个或多个微芯片40和传感器50，它们以如上所述的方式收集和传送植入物/病人信息。
如图10所示，本发明的另一实施方案可以是牵引器，如上颌面牵引器。牵引器240采用骨钉242固定到骨段244上，并且包括一个或多个微芯片40和传感器50。在此实施方案中，牵引器240在该牵引器的调整过程中向医师或病人提供实时反馈。另外，微芯片40也可以用于根据牵引器240上的微芯片40和传感器50所记录的数据自动地驱动牵引器调整(例如，通过马达、螺线管等)。
类似地，如图11所示，本发明也可采用外部固定装置的形式，如空间环(spatial ring)、腕关节固定件或其它骨固定系统。外部固定件250采用杆254与骨段252连接。一个或多个微芯片40和传感器50记录与固定系统有关的数据并将其传送给医师和病人。与上述牵引器240相同，外部固定件250可在该装置的调整过程中向医师或病人提供实时反馈，且微芯片40可根据记录的植入物和病人数据自动地驱动该固定件调整。
本发明的另一实施方案提供由所述植入物的制造商维护的中央网络服务器。该网络服务器与安装和维护该植入物的各个医生连通。当医生使用计算机或无线设备从植入物收集信息时，该医生可将此信息传送到中央网络服务器。然后，该制造商可使用该信息来确定特定植入物型号的平均使用寿命，且还可以编译所述数据来确定引起这种植入物型号失效的共同原因。该制造商还可以使用这种数据来确定是否可以用植入物成功或失效的倾向来教导外科医生对特定植入物的最有效安装技术。这种信息有助于制造商设计新的和改进的植入物，并且使安装技术更精湛。
虽然已参考优选实施方案对本发明进行了描述，但是本领域的普通技术人员应该认识到，只要不脱离本发明的范围还可以做出多种变化和改变。对于植入物和传感器的具体形状和构造尤其如此。例如，用于测量形变、温度和压力和/或负荷周期的传感器实质上可用于任何已知的整形固定应用中。这种应用的非限制性举例包括：上颌面固定应用中使用的骨板、与面部牵引系统一起使用的足板、头盖片夹子、与外部固定装置一起使用的销、脊柱融合板、脊柱融合杆组件等等。
因此，可以清楚地理解，如上所述的本发明的实施方案对本发明的范围没有限制，本发明仅由所附权利要求限定。

Claims (43)

1.植入物，其包括：
构造成与病人组织接触的本体部；
微芯片；和
多个设置在所述植入物的所述本体部上且与所述微芯片连接的传感器；其中，至少一个传感器被构造成从所述植入物的一部分或病人组织上接收物理刺激。
2.如权利要求1所述的植入物，其特征在于，所述微芯片还包括数据记录装置。
3.如权利要求2所述的植入物，其特征在于，所述微芯片还包括电源。
4.如权利要求3所述的植入物，其特征在于，所述电源是电池。
5.如权利要求1所述的植入物，其特征在于，所述植入物是骨板。
6.如权利要求1所述的植入物，其特征在于，所述植入物包括涂层。
7.如权利要求6所述的植入物，其特征在于，所述涂层包括聚合物或多孔金属。
8.如权利要求7所述的植入物，其特征在于，所述涂层包括药物活性试剂。
9.如权利要求1所述的植入物，其特征在于，所述植入物是髓内钉。
10.如权利要求1所述的植入物，其特征在于，所述植入物是脊柱固定元件。
11.如权利要求10所述的植入物，其特征在于，所述脊柱固定元件包括椎弓根螺钉、脊柱固定板、脊柱固定杆和脊柱固定钩中的至少一种。
12.如权利要求1所述的植入物，其特征在于，所述至少一个传感器被构造成适于接收来自所述植入物的至少一部分的形变。
13.如权利要求1所述的植入物，其特征在于，所述至少一个传感器被构造成适于接收施加在所述植入物的至少一部分上的压力。
14.如权利要求1所述的植入物，其特征在于，所述至少一个传感器被构造成适于接收所述植入物的至少一部分的温度。
15.如权利要求1所述的植入物，其特征在于，所述至少一个传感器被构造成适于记录图像。
16.如权利要求1所述的植入物，其特征在于，所述至少一个传感器被构造成适于发出电流以刺激骨生长。
17.如权利要求1所述的植入物，其特征在于，所述病人组织包括折裂的第一骨部分和第二骨部分，所述植入物还包括构造成可对该第一骨部分和第二骨部分施加微动以促进该第一折裂的骨部分和第二折裂的骨部分融合的元件。
18.如权利要求1所述的植入物，其特征在于，所述植入物还包括用于对施加到该植入物上的加载周期的数量进行计数的计数器。
19.如权利要求1所述的植入物，其特征在于，还包括用于存储治疗性试剂的腔室。
20.如权利要求19所述的植入物，其特征在于，所述治疗性试剂包括抗生素、生长因子、止痛药、化疗试剂和生长抑制剂中的至少一种。
21.如权利要求1所述的植入物，其特征在于，所述植入物是椎间植入物。
22.如权利要求1所述的植入物，其特征在于，所述植入物是牵引器。
23.如权利要求1所述的植入物，其特征在于，所述植入物是外部固定装置。
24.用于固定骨的植入物，其包括
构造成与骨接触的本体部；
所述本体部内用于容纳固定件的多个孔；
板载微芯片，其包括数据记录装置、信号调节器、多路转接器和发送器；和
多个传感器，其与所述微芯片连接且设置在所述植入物的多个位置上；
其中，所述传感器被构造成接收来自所述植入物一部分或骨的至少一种物理刺激。
25.如权利要求24所述的植入物，其特征在于，所述植入物包括骨板。
26.如权利要求24所述的植入物，其特征在于，所述植入物包括髓内钉。
27.如权利要求24所述的植入物，其特征在于，所述植入物是脊柱固定元件。
28.如权利要求27所述的植入物，其特征在于，所述脊柱固定元件包括椎弓根螺钉、脊柱固定板、脊柱固定杆和脊柱固定中的至少一种。
29.如权利要求24所述的植入物，其特征在于，所述多个传感器设置在所述孔的周围。
30.如权利要求24所述的植入物，其特征在于，所述传感器之一选自压力变换器、热偶、变形测量器、数字成像元件和周期计数器中的至少一种。
31.修复断骨的方法，包括：
(a)提供具有微芯片的骨固定植入物；
(b)将多个传感器设置在所述植入物上；
(c)将所述多个传感器与所述微芯片连接；
(d)用多个固定件将所述植入物固定到所述断骨的第一部分和第二部分上；
(e)采用所述微芯片从所述传感器收集数据；和
(f)将所述数据从所述微芯片传送到外部接收装置上。
32.如权利要求31所述的方法，其特征在于，所述至少一个传感器是热偶。
33.如权利要求31所述的方法，其特征在于，所述至少一个传感器是压力变换器。
34.如权利要求31所述的方法，其特征在于，所述至少一个传感器是变形测量器。
35.如权利要求31所述的方法，其特征在于，所述至少一个传感器是数字成像元件。
36.监测系统，其包括：
植入物，其具有至少一个传感器且被构造成至少部分地插入到病人体内；
微芯片，其与所述植入物和所述传感器连接，该微芯片被构造成接收来自所述传感器的至少第一信号；
发送器，其与所述微芯片连接以发送代表所述第一信号的第二信号；
位于病人体外的接收器，该接收器被构造成接收所述发送的第二信号；和
与所述接收器连接的显示设备，该显示设备被构造成向使用者提供代表所述第二信号的声音或可视信息。
37.如权利要求36所述的监测系统，其特征在于，所述微芯片还包括数据记录装置。
38.如权利要求36所述的监测系统，其特征在于，所述显示设备还被构造成连续地记录所述发送的第二信号。
39.如权利要求36所述的监测系统，其特征在于，所述植入物是骨板。
40.如权利要求36所述的监测系统，其特征在于，所述至少一个传感器被构造成适于接收来自所述植入物的至少一部分的形变。
41.如权利要求36所述的植入物，其特征在于，所述至少一个传感器被构造成适于接收施加在所述植入物的至少一部分上的压力。
42.如权利要求36所述的植入物，其特征在于，所述至少一个传感器被构造成适于接收所述植入物的至少一部分的温度。
43.如权利要求36所述的植入物，其特征在于，所述植入物还包括用于容纳治疗性试剂以响应所述微芯片接收到的信号而释放的腔室。
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US8551092B2 (en) 2013-10-08
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