CN1350667A - 产生病人专用移植物的方法 - Google Patents

产生病人专用移植物的方法 Download PDF

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CN1350667A
CN1350667A CN00807348A CN00807348A CN1350667A CN 1350667 A CN1350667 A CN 1350667A CN 00807348 A CN00807348 A CN 00807348A CN 00807348 A CN00807348 A CN 00807348A CN 1350667 A CN1350667 A CN 1350667A
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data
graft
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彼得·利奇科
托尔斯滕·亨宁
约尔格·拜内曼
沃尔夫冈·弗里德
维尔纳·林斯
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Ralph Sid
Thomas Kerbs
3Di GmbH
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3Di GmbH
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Abstract

本发明涉及一种产生病人专用移植物的方法,这种方法是基于对病人的医学影象的检验结果而产生病人专用的移植物。本发明的目的是,与病人伤口位置的大小、形状、复杂性无关地,产生功能出色、非常美观地适合于病人的移植物,它不仅可以很快而且可以低成本地进行制作,还可以在手术过程中将其植入病人体内。这种方法可以同样精确地被用于所有形状、大小以及所有可考虑的移植材料。根据本发明,把病人的实际三维模型(由记录在案的现有病人两维图像数据形成的)与实际医学基准数据进行比较。例如用存有先人数据的数据库进行的比较,根据比较结果来选择或产生最适用于病人或与病人模型最相似的基准模型目标,根据这个基准模型目标产生实际移植物目标。直接由计算机中实际产生的移植物模型产生CNC控制器数据,用于编程控制移植物的制作。

Description

产生病人专用移植物的方法
本发明涉及基于由形成图像的医学方法得到的现有病人检验结果而产生病人专用移植物。
很久以来，一直可以使用体外物质(移植物)来弥补器官伤口。实际的现有技术是，在采用真正存在的中间模型的情况下，通过在手术时形成移植物来产生专用于病人的硬组织移植物，或者在把CAD/CAM—技术用作计算机支持结构的辅助工具地来形成硬组织移植物。在这种情况下，逐渐形成图像的医学方法如计算机层析X射线摄影术(Computeromographie)、原子核X射线扫描术(Kernspintomographie)、超声波扫描术等是产生的移植物基础。
有限地采用可成型或可加工的金属网、金属片、易变形材料(其在短时间后硬化，如塑料)和病人人体的固有物质进行移植是医学中的常见做法(如参见US4,097,935，US4,976,737)，在手术时利用所述移植物来堵住伤口，即在手术时制成、加工移植物并使其与伤口形状相符。不过，金属移植物如网、片等可能在随后的病人诊断时很麻烦，确切地说，尤其是在大伤口时，将来会使一些检验方法变得不可能。手术过程一般由处理情况本身和医生经验来决定，在这种情况下，在植入移植物前确定手术方案的可能性就象没有那样。因此，对于手术病人来说，需要常见的术后处理，这又是病人的肉体和精神负担。此外，一些容易变形和/或生产成本较低的材料如塑料在负荷能力和耐久性方面有其使用局限的一面。为此，病人希望获得美观的外形，而这在许多情况下是很难实现的。
这样的情况也是可行的(“在颅上颌面手术中的立体平版印刷生物建模，有希望的尝试”，颅上颌面手术杂志，1999年，第27期或US5,370,692、US5,452,407或US5,741,215)，即移植物拟订和产生实体三维中间模型例如是基于上述形成图像的医学检验方法并通过立体平版印刷法开始的。随后，在采用可塑性变形材料的情况下，把移植物模拟地加入伤口中并随后以最终形式由移植材料制成移植物。在这里，最好由高强度材料如钛来制作移植物。
以下也是公知的(“头盖骨移植—计算机辅助设计和制作”，科学丛书，1999年2月；“用单个的钛移植物重建颅颌面骨格缺陷”，德国的医生报刊，1997年9月)，由病人的图像形成检验法的数据产生简单的三维CAD病人模型并根据这个模型病症采用简单的造型方法的情况下在计算机上人工草拟移植物。随后，通过CNC方法制作出手术用的移植物。
但是，所有已知方法都有这样的缺点，即移植物建模的结果主要由产生或制造移植物的人的经验、能力、审美观来决定。从现有数据到制成可在手术中使用的合格移植物，其成本高并且时间长，在加工所谓的中间模型的情况下，时间更长。在手术中的移植物的制作需要相当长的手术时间和相当费事的手术组织工作，因而，最终对病人来说，这是很大的肉体和精神负担。此外，从医学和美学的观点出发，很难有效且形状匹配地使用不适应病人伤口位置的移植物。通常，外科医生的突出能力和经验对手术结果有重要影响。第一种方法在实践中和在临床程序范围内只被用在小伤口和/或结构小的损伤，对于在复杂伤口和移植物中的成型和匹配来说，它受到其生产技术的限制。
移植物与伤口位置匹配能力很大程度上决定了手术是否费事。确切地说，在通过中间模型制造移植物时，中间模型的仿制还不利地影响了精度。
在复杂情况下，移植物必须通过漫长的且很费时的过程，或许还要通过多个中间步骤来制造。在这种比较长的期间里，病人的伤口区或许在这段期间里变化了。实际上，移植物的尽可能精确的匹配能力没有充分地考虑到这种改变并且这使手术更加费事。
从以上以及病人的角度出发，最好尽快(就手术而言)并且与病人伤口位置很匹配地制作出移植物。根据病人手术前的手术方案，不仅应该给治疗的外科医生指示出病人的伤口位置，还要指示出要植入的移植物的形状和尺寸。
本发明的任务是，与病人伤口位置的大小、形状、复杂性无关地，产生功能出色、非常美观地匹配于病人的移植物，它不仅可以很快速地且成本低地进行制造，而且可以在手术过程中被植入病人体内。这种方法可以同样精确地被用于所有形状、大小以及所有可考虑的移植材料。
根据本发明，病人的实际三维模型(其众所周知地由记录在案的且至少用于其移植物区和周围区的现有(两维)图像数据形成)与实际医学基准数据进行比较。根据比较结果，选择最适用于病人的或与病人模型最相似的基准模型目标，根据基准模型目标产生实际的移植物模型。根据计算机中的实际移植物模型数据，直接产生用于移植物的编程控制制造的CNC控制器数据。与实际医学基准数据的比较不仅可以在存储有大量先人(probanden)(其它人)的医学数据的数据库中进行，而且可以在采用病人本身数据的情况下进行，为了选择或产生病人基准模型，考虑使用其人体对称性(尤其是是双重存在的人体镜像对称区)。也可以考虑将早先的病人检验数据(还没有伤口或者与伤口变化有关)用于这种比较。
这样一来，实际上在美观和功能方面并且在计算技术(软件)方面不太费事地很快建立病人的具体模型，而且对所需的移植物的任何形状、尺寸、复杂度来说，移植物都很精确地匹配于病人的伤口位置。根据利用CAD-CAM辅助产生并且与伤口位置或代表性比较数据匹配的实际移植物模型，治疗的外科医生可以获得很实在的指示，以便客观地在实际模型上实施手术方案，并且在手术准备阶段模拟手术过程，由此更好地准备和进行真正的手术及其过程，并因而客观地评估，可能的话，也可以实现与病人商量并确定手术方案。从病人基准模型中，通过采用数学算法抽出移植物模型，并由此直接推导出用于填充或堵塞伤口位置的移植物的控制器数据，从而可以有利地马上编程控制本身已知的CNC控制器的移植物，并且不需要中间模型或试验模型(尤其是用于仿制、试验、改善、修正以及新加工)，按人体形成移植物。利用CNC控制制造机械(计算机支持地给其传输数据)，可以由包括陶瓷和钛在内的任何材料进行制造，从而为每个病人，在所需性能(功能、负荷能力、可吸收性、耐久性、美观、生物互容性等)方面选择移植物。保证最快的移植物制作(它从手术的新观点或变化观点来看也可以快速重复)缩短了临床工作中的时间过程和组织过程，并且减少了外科医生的精力耗费，同时降低了病人的安全风险。尤其是从病人的角度出发，通过精确地使要生产的移植物匹配于伤口区而获得了美观的植入伤口区，并且避免或至少在范围和次数上减轻了外科修复、整形以及所谓的后续手术的负担，这是有利的。
以下，结合附图所示的实施例来详细说明本发明。其中：
图1是一般的方法示意图；
图2是具体的方法示意图；
图3表示医学两维图像数据的整理；
图4表示三维病人模型的产生；
图5表示反转模型；
图6表示三维基准模型；
图7表示三维移植物模型。
例如，病人在上头盖骨上具有大面积创伤(如因事故、肿瘤等)。在图1、2中，为了表现本发明的方法，不仅画出了一般的示意图，而且画出了具体的方框示意图。
为了精确诊断并随后产生移植物，在医院放射科(如利用计算机层析X射线摄影术或原子核X射线扫描术)中，拍摄伤口区5及其周围的医学两维图像数据1(两维分层图像)(图3)。
在采用数学图形处理算法的情况下，在两维图像数据1中首先进行轮廓识别，随后进行片段划分，其目的是探测硬组织区(骨头)。在识别了轮廓并且划分片段后，形成了两维图像数据2，根据这些数据并通过相应的空间排列而至少形成了伤口区5及其周围的实际三维病人模型3(点模型)。
在医生和设计师的配合下，在实际三维病人数据模型3上，在采用专用于此的计算机程序的情况下精确地确定和标记出伤口区。
接着，可以使用各种产生精确匹配的移植物的方法来制作该移植物。其中：
1、在三维病人模型4(见图5，表示为横截面形式)上，伤口区5完全在半个人体内，即完全在头的一侧，因而，利用人体对称性，这个有伤口区5的人体一侧的数据通过转换器8而由三维病人模型4完好一侧7的数据仿制而成(完好侧7在对称面6上的镜像)。在反转后，通过使用数学算法(在此未详细说明)进行实际移植物模型9的提取。
2、在三维病人模型10(在图6中以侧视图表示)上，伤口区5位于人体对称面上，或者可以不因任何理由使用完好侧的数据，这样一来，通过三维实际模型11产生了实际移植物模型9。根据基准数据库中的三维病人模型10的专用标记的比较，在考虑了数学、功能、医学、美学的观点的情况下，选择类似模型。最后，根据这种选择，最好在尤其是医学鉴定的情况下，选择三维基准模型11。通过三维基准模型11与三维病人模型10的叠加，出现了实际三维病人模型12，根据这个模型，又如第1项所述的那样，在计算机中产生实际移植物模型9。
3、在特殊情况下，如当伤口部分位于对称面上时，先后采用这两种方法(根据第1项的反转和根据第2项的数据库比较)，综合结果而形成一个用于移植物建模的三维基准模型。
根据至少一种已知方法来选择和/或建立三维基准模型并由三维基准模型产生实际移植物模型只通过计算技术来实现。利用这种处理方法，不仅很快而且很精确地产生了移植物，并且随后制造出移植物，以便在手术时植入病人体内。
在产生了以后，现有的实际移植物模型9(图7)接受各种处理，例如可能包括固体计算、医学手术方案和实施的模拟以及安装标记(孔、固定件等)、质量控制等。
根据实际移植物9的方案，为制作人体移植物而产生/模拟CNC控制器数据，并且将实际移植物模型转变为可用的移植物。
附图标记—览表：
1—医学的两维图像数据；
2—轮廓识别和片段划分的两维图像数据；
3—三维病人模型(点模型)；
4—三维病人模型(横截面)；
5—伤口区；
6—医学上的人体对称面；
7—三维病人模型的完好侧；
8—完好侧7的反转体；
9—移植物模型；
10—三维病人模型(侧视图)；
11—三维基准模型；
12—三维病人模型；

Claims (5)

1.一种产生病人专用移植物的方法，其中，根据从病人那得到的至少移植区和周围区的图像数据产生实际三维模型，并且根据CNC控制器数据制作移植物以便通过手术植入病人体内，其特征在于，把病人的实际三维模型与实际医学基准数据进行比较，根据比较结果，选择或建立最适用于病人或与病人模型最相似的基准模型目标，根据基准模型目标产生实际的移植物模型，移植物模型的实际数据被用作控制数据，用于编程控制移植物的制造。
2.如权利要求1所述的方法，其特征在于，将病人的实际三维模型与一个数据库的实际医学基准数据比较，从存储于数据库的数据中选择最适用于病人的或与病人模型最相似的基准模型目标。
3.如权利要求2所述的方法，其特征在于，从存储于数据库中的数据中选择出至少多个与病人模型相似的基准模型目标，在考虑了其它选择标准如医学专家鉴定的情况下，从这些基准模型目标中选择出最适用于病人或与病人模型最相似的基准模型目标。
4.如权利要求1所述的方法，其特征在于，最好在考虑了人体对称性，尤其是双重存在，以及人体区的镜面对称，和/或考虑了病人的旧数据的情况下，把病人的实际三维模型与病人自身的数据进行比较，从这些数据中选择出或建立最适用于病人或与病人模型最相似的基准模型目标。
5.如权利要求1、2和4所述的方法，其特征在于，不仅把病人的实际三维模型与一个数据库的实际医学基准数据进行比较，还将病人的实际三维模型与病人自身的数据进行比较，从这些数据中选择出或建立最适用于病人或与病人模型最相似的基准模型目标。
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