CN1780594A - 用于确定半月板的大小和形状以及设计治疗的方法 - Google Patents
用于确定半月板的大小和形状以及设计治疗的方法 Download PDFInfo
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Abstract
本发明涉及用于判定在设计治疗多种关节疾病的疗法中使用的半月板尺寸和形状的方法。本发明使用经处理以供分析的关节图像。分析可包括(例如)产生厚度图、软骨曲度、或点云。此信息用于判定软骨缺损或损伤程度并设计适当的疗法,包括(例如)植入物。对所设计的疗法进行调整以解决所使用的材料。
Description
技术领域
本发明涉及确定半月板的大小和形状以用于设计治疗各种关节疾病的疗法的方法。这种方法接着用于设计用于关节的植入物或关节修复系统。
背景技术
存在各种类型的软骨,例如透明软骨和纤维软骨。在(例如)关节的骨骼的关节表面有透明软骨,且其负责提供可移动关节的平滑运动特征。关节软骨稳定的附着到基础骨骼上且在人体关节中的测得通常具有小于5mm的厚度,并且取决于关节和特定而言在关节内的位置而具有相当大的变化。另外,关节软骨是非神经的、非血管的且非淋巴的。
成人软骨具有有限的修复能力;因而,由疾病造成的软骨损坏,例如风湿性关节炎和/或骨关节炎或外伤可导致严重的身体畸形和虚弱。另外,当人体关节软骨老化时,其可拉伸特性发生改变。因而,成人软骨的抗张硬度和强度因老化过程而随时间显著减少。
举例而言,人在30岁前,膝关节软骨的表面区的抗张强度是增加的,而随后,随着年龄变大而显著减少,在关节表面可检测到出现II型胶原质检测损坏。随着年龄的增长,深区软骨的抗张强度也表现出逐渐的减少,尽管胶原质含量没有出现减少。这些观察表明了随着人变衰老在软骨的机械组织上且由此在结构组织上会发生变化,而如果让这种变化充分发展的话,就会容易使软骨提前出现外伤损坏。
一旦发生了损坏,可通过多种方法达成关节修复。基质、组织骨架或与细胞(例如,软骨细胞、原始软骨细胞、基质细胞、间叶干细胞等)一起植入的其它载体的使用已被描述成用于软骨和半月板修复或替换的潜在治疗方法。还是参阅Fofonoff的1999年10月14日公开的国际公开案WO 99/51719;Simon等人的2001年12月6日公开的WO01/91672;和Mannsmann的2001年3月15日公开的WO01/17463;2001年9月4日颁给Vibe-Hansen等人的美国专利第6,283,980B1;1998年12月1日颁给Naughton的美国专利第5,842,477号,1998年6月23日颁给Schwartz等人的美国专利第5,769,899号,1986年9月2日颁给Caplan等人的美国专利第4,609,551号,1991年8月29日颁给Vacanti等人的美国专利第5,041,138号,1993年3月30日颁给Caplan等人的美国专利第5,197,985号,1993年7月13日颁给Caplan等人的美国专利第5,226,914号,2001年12月11日颁给Hardwick等人的美国专利第6,328,765号,2001年8月28日颁给Rueger等人的美国专利第6,281,195号和1989年7月11日颁给Grande的美国专利第4,846,835号。然而,使用例如同种异体移植和自体移植系统和组织骨架的生物替换材料的临床结果具有不确定性,因为大多数这些材料不能实现与将要替换的正常的、无病的人体组织类似或相同的形态布置。另外,这些生物替换材料的机械耐用性也是不确定的。
软骨的严重损坏和缺失通常是通过使用修补材料来治疗,例如硅树脂用于如美容修复、或合适的金属合金。参阅,例如2002年9月3日颁给Running的美国专利第6,443,991号,2002年5月14日颁给Miehike等人的美国专利第6,387,131B1号;2002年5月7日颁给Schmotzer的美国专利第6,383,228号;2001年2月5日颁给Krakovits等人的美国专利第6,344,059 B1号;2001年3月20日颁给Afriat等人的美国专利第6,203,576号;2000年10月3日颁给Ateshian等人的美国专利第6,126,690号;2000年1月11日颁给Kaufman等人的美国专利第6,013,103号。这些修补装置的植入通常与缺失基础组织和骨骼而无法恢复由原始软骨所允许的全部功能相关联,使用某些装置时,与大量的组织和骨骼的缺失相关联的严重的长期并发症可包括感染、骨质溶解和植入物的松动。
可了解,关节造形手术是高度扩散性的且需要手术切除进行修复所涉及的一个或一个以上骨骼的整个或大部分关节表面。通常,通过这些程序,髓隙被大面积的扩孔以将修补物的茎干安装到骨骼内。扩孔会导致病人骨存量(bone stock)的损失,且继发的骨质溶解将随着时间不断导致修补物的松动。另外,植入物和骨骼配接的区域会随着时间退化,最终需要替换修补物。因为病人的骨存量是有限的,所以对于关节造形手术来说,可能进行的替换手术的数量也是有限的。简单来说,在15到20年的过程中,或在某些情形下甚至更短的时期,病人会用尽治疗的选择,最终导致痛苦的、功能不全的关节。
2001年3月27日的美国专利第6,206,927号和2003年5月6日颁给Fell等人的美国专利第6,558,421号揭示了一种无需切除骨骼即可手术植入的膝盖修补物。所描述的这种修补物大体上是椭圆形状,具有一个或一个以上的直边。因此,所设计的这些装置实质上与体内剩余的软骨和/或基础骨骼的实际形状(轮廓)并不一致。因而,由于病人的周围软骨和/或基础软骨下骨与修补物在厚度和曲率上的差异,使植入物的整合变得极其困难。
已经描述可不附着到胫骨和股骨(femur)的插入型膝盖装置。举例而言,Platt等人的(1969)“Mould Arthroplasty of the Knee”,Journal of Bone and Joint Surgery 51B(1):76-87中描述了具有并不严格附着到胫骨的凸起底面的半关节造形术。
1985年5月5日颁给Wall的美国专利第4,502,161号描述了由例如硅树脂橡胶或特氟纶(Teflon)的材料与不锈钢或尼龙绳加固材料构造的修补半月板。1978年3月25日颁给Goodfellow等人的美国专利第4,085,466号描述了由塑料材料制成的半月板组件。还已经尝试了使用碳纤维聚氨酯聚(左旋丙交酯)重建半月板损害。Leeslag等人的“Biological and BIOMECHANICAL Performance of BIOMATERIALS”(Christel等人编)Elsevier科学出版社B.V.,Amesterdam.1986.第347-352页。也可使用生物可再吸收材料和组织骨架来重建半月板损害。
然而,目前可用的装置并不是总能提供与关节表面形成理想的对准,从而所得的关节和谐性也并不总是理想。较差的对准性和较差的关节和谐性可(例如)导致关节不稳定。在膝关节中,不稳定性通常表现为关节的横向不稳定性。
因而,仍然需要能再现关节的两个关节表面(例如股骨髁和胫骨平台)之间的自然或接近自然的关系的方法。
发明内容
一方面,当实验体中存在半月板时,本发明包括测量半月板的尺寸和/或形状参数。这些尺寸和参数包括例如(但不限于)半月板最大前后距离、半月板最大内外距离、半月板附着物的大小和面积、前角最大长度、前角最大和最小高度、骨体最大和最小高度、后角最大和最小高度、半月板最大高度和最小高度、前角最大和最小宽度、骨体最大和最小宽度、后角最大和最小宽度、各位置的半月板半径和角度。这些测量可接着用于设计治疗关节疾病的疗法。这些治疗可包括(例如)半月板修复系统、软骨修复系统、关节修复系统和关节造形系统且其可由以下各物组成:例如,生物材料、组织骨架、塑料、金属或金属合金、或其组合。疗法可以是定制的,通常利用这些测量中的至少一个或一个以上的测量。或者,可选择与这些测量中的一个或一个以上测量紧密匹配的预制“现成的”组件。
另一方面,本发明包括测量对侧半月板的尺寸和/或形状参数。这些尺寸和参数包括例如(但不限于)半月板最大前后距离、半月板最大内外距离、半月板附着物的大小和面积、前角最大长度、骨体最大长度、后角最大长度、前角最大和最小高度、骨体最大和最小高度、后角最大和最小高度、半月板最大高度和最小高度、前角最大和最小宽度、骨体最大和最小宽度、后角最大和最小宽度、各位置的半月板半径和角度。
在一个实施例中,相对隔室的半月板可用于产生患病侧半月板的镜像。这些测量接着可用于确定半月板的大小和/或形状以设计用于患病关节的疗法。这些疗法可包括:例如,半月板修复系统、软骨修复系统、关节修复系统和关节造形系统,且其可由以下各物组成:例如,生物材料、组织骨架、塑料、金属或金属合金、或其组合。疗法可以是定制的,通常是使用这些测量中的至少一个或一个以上的测量。或者,可选择与这些测量中的一个或一个以上测量匹配或紧密匹配的预制“现成的”组件。
在另一个实施例中,可从来自相邻关节表面和结构的测量得出半月板被感染部位的3D几何形状,以再现患病半月板的形状和大小。这些测量包括例如(但不限于):胫骨尺寸,例如最大的前后距离、最大的内外距离、从胫骨脊骨到边缘的最大距离、胫骨脊骨的宽度、胫骨脊骨的高度、胫骨脊骨所占据的胫骨平台面积、胫骨平台的深度、胫骨平台的2D和3D形状;股骨髁骨骼尺寸,例如最大的前后距离、最大的上下距离、最大的内外距离、从滑车到内边缘或外边缘的最大距离;髁间凹(intercondylar notch)的宽度和深度、沿着股骨髁的选择区域的曲率、2D和3D形状。
另一方面,当应用到膝关节时,本发明包括一个或一个以上的以下测量:(1)胫骨尺寸,例如最大的前后距离、最大的内外距离、从胫骨脊骨到边缘的最大距离、胫骨脊骨的宽度、胫骨脊骨的高度、胫骨脊骨所占据的胫骨平台面积、胫骨平台的深度、胫骨平台的2D和3D形状;(2)股骨软骨尺寸,包括厚度和形状;(3)股骨髁骨骼尺寸,例如最大的前后距离、最大的上下距离、最大的内外距离、从滑车到内边缘或外边缘的最大距离;髁间凹的宽度和深度、沿着股骨髁的选择区域的曲率、2D和3D形状;和(4)股骨髁测量,包括厚度和形状。这些测量可接着用于估计半月板的大小和/或形状用于治疗关节疾病。这些治疗可包括:例如,半月板修复系统、软骨修复系统、关节修复系统和关节造形系统且其可由以下各物组成:例如,生物材料、组织骨架、塑料、金属或金属合金、或其组合。疗法可以是定制的,通常利用这些测量中的至少一个或一个以上测量。或者,可选择与这些测量中的一个或一个以上测量紧密匹配的预制“现成的”组件。
在另一方面,半月板测量是从具有正常或接近正常的半月板的参考人群中获得的。半月板测量可包括例如(但不限于):半月板最大前后距离、半月板最大内外距离、半月板附着物的大小和面积、前角最大长度、骨体最大长度、后角最大长度、前角最大和最小高度、骨体最大和最小高度、后角最大和最小高度、半月板最大高度和最小高度、前角最大和最小宽度、骨体最大和最小宽度、后角最大和最小宽度、各位置的半月板半径和角度。
还可利用相同的参考人群获得其它非半月板测量,且可包括一个或一个以上的以下测量:(1)胫骨尺寸,例如最大前后距离、最大内外距离、从胫骨脊骨到边缘的最大距离、胫骨脊骨的宽度、胫骨脊骨的高度、胫骨脊骨所占据的胫骨平台面积、胫骨平台的深度、胫骨平台的2D和3D形状;(2)股骨软骨尺寸,包括厚度和形状;(3)股骨髁骨骼尺寸,例如最大前后距离、最大上下距离、最大内外距离、从滑车到内边缘或外边缘的最大距离、髁间凹的宽度和深度、沿着股骨髁的选择区域的曲率、2D和3D形状;和(4)股骨髁测量,包括厚度和形状。(5)测量膝盖骨尺寸;(6)测量膝盖骨软骨尺寸,包括厚度和形状;和/或(7)测量例如十字韧带的韧带结构的大小、长度或形状。
参考人群的半月板的大小和/或形状可接着与一个或一个以上的其它非半月板的测量相关联。一旦建立关联,与半月板大小和/或形状最有关联的骨骼和/或软骨和/或韧带的尺寸可用于预测半月板大小和/或形状,以设计用于正遭受关节疾病痛苦的病人的疗法。来自参考人群的数据通常存储在数据库中,该数据库可定期地或连续地进行更新。利用这些信息,疗法可以是装置,包括(例如)半月板修复系统、软骨修复系统、关节修复系统和关节造形系统且其可由以下各物组成:例如,生物材料、组织骨架、塑料、金属或金属合金、或其组合。疗法可以是定制的,通常利用这些测量中的至少一个或一个以上的测量。或者,可选择与这些测量中的一个或一个以上测量紧密匹配的预制“现成的”组件。举例而言,可利用这些信息来选择半月板修复系统。或者,这些信息可用于定形插入型关节造形系统。
附图说明
图1A说明同心排列的光环的Placido盘的实例。图1B说明将Placido盘投影到一固定曲率表面上的实例。
图2显示了将同心光环(Placido盘)投影到每个股骨髁上所产生的反射,展示了反射环上的表面轮廓的变化效果。
图3说明不规则曲面的2D色码构形图的实例。
图4说明不规则曲面的3D色码构形图的实例。
图5说明使用激光扫描仪使MRI表面和数字化表面的表面配准。左边的图示显示配准前的表面,且右边的图示显示配准后的表面。
图6是股骨远端的关节软骨的三维厚度图的再现。例如可从超声波、CT或MRI数据生成三维厚度图。软骨物质内的黑洞指示整个厚度软骨缺失区域。
图7说明来自矢状扫描(蓝色)和冠状扫描(红色)的股骨内侧髁的软骨表面。
图8A说明半月板的轴向图;图8B说明半月板的矢状图;和图8C说明半月板的冠状图。
图9A说明胫骨的矢状图;和图9B说明胫骨的冠状图。
图10A说明股骨的矢状图;和图10B说明股骨的冠状图。
图11A-C说明一个组合图,其显示从冠状FSE提取之后的胫骨软骨表面和上半月板表面,和标度被设为可以承担在负重状态下的压缩的半月板表面。图11C是从所述信息得出的植入物的横截面。
图12说明接近光滑曲面片(棕色)的植入物表面(黄色)的点云。
图13A和图13B是适用于股骨髁上的植入物的视图,其分别显示了上表面和下表而视点。
图14是适用于膝盖中的一部分胫骨平台的植入物的视图。
图15A-D是适用于髋部的植入物的视图。
具体实施方式
下文的描述是使所属领域的任何技术人员能够制造并使用本发明。所属领域的技术人员将不难发现,可对所描述的实施例做出多种修改,且本文所界定的一般原则可应用于其它实施例和应用,而不背离由随附的权利要求书所界定的本发明的精神和范畴。因此,本发明不欲受限于所示实施例,而将赋予其与本文所揭示的原则和特征一致的广泛范畴。在为了达成对所揭示的本发明的完全理解所必需的意义上来说,在本应用中所引用的已经发行的专利、专利申请案、和专利申请案的说明书和附图都以引用的方式并入本文。
所属领域的技术人员将了解,除非另外说明,否则本发明的实践利用了此项技术中的x射线成像和处理、x射线断层组合(tomosynthesis)、包括A扫描、B扫描和C扫描的超声波、计算断层照相术(computed tomography)(CT扫描)、磁共振成像(MRI)、光学相干断层照相术、单光子发射断层照相术(SPECT)和正电子放射断层照相术(PET)等常规方法。在文献中充分解释所述技术且不需要在本文中赘述。参阅,例如1989年John WILEY & Sons出版社的第二版X-Ray Structure determination:A Practical Guide(Stout和Jensen编);1999年McGraw-Hill出版社的“Body CT:A Practical Approach(Slone编);1998年Springer-Verlag出版社的X-ray Diagnosis:A Physician′s Approach(Lam编);和1997年牛津大学出版社Understanding the X-Ray Image:Understanding theX-Ray Image(Laetitia Brocklebank编)。
本发明通过提供用于确定半月板尺寸和形状的方法来解决重建两个关节表面之间的自然或接近自然的关系。半月板尺寸和形状可用于设计治疗关节疾病的疗法,包括(例如)半月板修复、半月板再生和关节修复疗法。
I.关节的评估
本文所描述的方法和组合物可用于治疗由软骨疾病(例如,骨关节炎)、骨骼损坏、软骨损坏、外伤和/或因过渡使用或老化引起的退化而导致的缺损。本发明允许尤其是保健医师评估并治疗所述缺损。
所属领域的技术人员将了解,可使用任何适当的技术获得尺寸、曲率和/或厚度测量结果。例如,可使用如下合适的手段获得一维、二维、和/或三维测量结果:机械构件;激光装置;应用于关节表面的硬化并“存储表面轮廓”的电磁或光学跟踪系统、模型、材料和/或一种或一种以上此项技术中已知的成像技术。可使用例如探针或其它外科装置来非侵害地和/或在手术中获得测量结果。所属领域技术人员将了解,修复装置的厚度可根据在关节表面上的任何特定位置的待矫正的软骨和/或骨骼的损坏的深度而定在任何给定点处变化。
A.成像技术
所属领域的技术人员将了解,适合于测量(例如,软骨和/或骨骼的)厚度和/或曲率或患病的软骨区域或软骨缺失区域的尺寸的成像技术包括使用x射线、磁共振成像(MRI)、计算断层照相扫描(CT,也称为计算机化轴向断层照相或CAT)、光学相干断层照相、SPECT、PET、超声波成像技术和光学成像技术。(又参阅,Alexander等人的于2002年3月21日公开的国际专利申请案WO 02/22014;2002年4月16日颁给Tsoref等人的美国专利申请案第6,373,250号;和Vandeberg等人的(2002)Radiology 222:430-436)。可使用任何给药途径(如静脉内、关节内等)来使用对比或其它增强药剂。
在某些实施例中,CT或MRI是用于评估组织、骨骼、软骨和其中的任何缺损(例如软骨病变或患病的软骨区域)以获得关于软骨下骨或软骨退化的信息且提供关于损坏区域的形态学或生物化学或生物机械学信息。特定而言,可使用一种或一种以上的所述方法来检测诸如裂隙、部分或全部厚度的软骨缺失等变化和在残留软骨内的信号变化。针对基本的NMR原则和技术的讨论,请参阅MRI Basic Principles and Applications(第二版),Mark A.Brown和Richard C.SEMELKA,Wiley-Liss,Inc.(1999)。针对MR1的讨论请参阅Alexander等人的WO 02/22014以获得关于软骨的信息,包括常规T1和T2-加权自旋回波成像、梯度回波(GRE)成像、磁转换对比(MTC)成像、快速自旋回波(FSE)成像、对比增强成像、快速捕捉弛豫增强(rapid acquisition relaxation enhancement,RARE)成像、稳定态梯度回波捕捉(gradient echo acquisition in steady state,GRASS)、和驱动平衡傅立叶变换(driven equilibrium Fourier transform,DEFT)成像。因此,在优选实施例中,所产生的测量是基于按Alexander等人的WO 02/22014中的描述获得的关节三维图像和最终产生3D信息的二维图像的集合。可获得单独的或与关节移动图案(例如,弯曲延伸、平移和/或旋转)相结合的二维和三维软骨图像或图象。三维图像可包括关于两个或两个以上的相对关节表面的移动图案、接触点、接触区域、和关节活动期间接触点或区域的运动。二维和三维图像可包括关于关节软骨的生化组合物的信息。另外,可在时间上比较成像技术(例如)以提供关于所需的修复材料的形状和类型的最新信息。
本文所描述的任何成像装置也可在手术中使用(又参阅下文),例如使用手提式超声波和/或光学探针以在手术中使关节表面成像。
B.手术中测量
另一选择,或在上述的非侵害成像技术之外还可在关节镜检查和关节切开术期间在手术中获得患病的软骨区域或软骨缺失区域的尺寸的测量、软骨厚度和/或软骨和骨骼的曲率的测量。手术中测量可或者也可不涉及与关节表面的一个或多个区域的实际接触。
适用于获得软骨或骨骼或其它关节结构的手术中测量并生成表面构形图的装置包括(但不限于)Placido盘和激光干涉仪和/或可变形材料或装置。(参阅,例如,2002年5月7日颁给Wooh等人的美国专利申请案第6,382,028号、2000年5月2日颁给Levesque等人的第6,057,927号、1996年6月4日颁给Yamane等人的第5,523,843号、1998年12月8日颁给Sarver等人的第5,847,804号和1997年11月4日颁给Fujieda的第5,684,562号。)
图1A为同心排列的光环的Placido盘。Placido盘的同心阵列投影出半径变化的界限分明的光环,其由经光纤传送的激光或白光产生。可将Placido盘连接到内窥镜装置(或任何探针,例如手持式探针)的术端,使得将光环投影到软骨表面上。图1B为投影到固定曲率的表面上的Placido盘的实例。可使用(例如连接到装置)一个或多个成像相机以捕捉所述环的反射。数学分析用于确定表面曲率。然后,例如可在一监视器上将曲率显象为软骨表面的色码构形图。另外,构形图的数学模型可用于确定理想的构形,以替代所分析的区域中的任何软骨缺损。
图2显示将同心光环(Placido光盘)投影到每个股骨髁上所产生的反射,展示反射环上的表面轮廓的变化效果。
类似地,也可将激光干涉仪连接到内窥镜装置的末端。另外,可将小的感测器连接到该装置上,以使用相移干涉仪确定软骨表面或骨骼曲率,产生软骨表面的干涉图案分析相位(波前)视图。然后,可在一监视器上将曲率显象为软骨表面的色码构形图。另外,构形图的数学模型可用于确定理想的构形,以替代所分析的区域中任何软骨或骨骼缺损。然后,可在监视器上显象此计算过的理想的(多个)表面,且所述表面可用于选择替代软骨的(多个)曲率。
所属领域的技术人员将不难发现,在不脱离本发明的范畴的情况下可使用其它用于光学测量软骨表面曲率的技术。举例而言,可产生诸如图3和图4中所示的2维或3维图。
机械装置(例如,探针)也可用于手术中测量,例如可变形材料如凝胶体、铸模、任何硬化材料(例如直到加热、冷却或进行其它处理时才不可变形的材料)。参阅Dickson等人的2002年5月2日公开的WO 02/34310。例如,可变形凝胶体可应用于股骨髁。指向髁的凝胶体侧可产生髁的表面轮廓的负面印迹。然后,该负面印迹可用于确定缺损的尺寸、缺损的深度和缺损中或缺损附近的关节表面的曲率。这个信息可用于选择一疗法,例如,关节表面修复系统。在另一个实例中,可向关节表面(例如股骨髁或胫骨平台)施涂硬化材料。所述硬化材料可留在关节表面上直到发生硬化。该硬化材料然后可从关节表面移除。指向关节表面的硬化材料侧可产生关节表面的负面印迹。然后,该负面印迹可用于确定缺损的大小、缺损的深度和缺损中或缺损周围的关节表面的曲率。然后,这个信息可用于选择一疗法,例如,关节表面修复系统。在某些实施中,硬化系统可保持在合适的位置且形成实际的关节表面修复系统。
在某些实施例中,可变形材料包括复数个个别可移动的机械元件。当压在相关的表面上时,可在相反的方向中推动每个元件且其推动(变形)的程度可对应于所述的相关表面的曲率。该装置可包括一制动机构,以可将所述元件保持在与软骨和/或骨骼的表面一致的位置。然后,可从病人身上移走该装置,并进行曲率分析。或者,每个个别的可移动元件可包括指示其在一给定点处的变形量和/或变形度的标记。相机可用于在手术中使装置成像且可以保存所述影像并分析所述影像的曲率信息。适当的标志包括(但不限于)实际的线性测量(米制或经验式(empirical))、对应于不同量的变形的不同色彩和/或同一色彩的不同暗度和色调。也可使用电子构件来测量可移动元件的位移。
其它用于在手术中测量软骨和软骨下骨的装置包括(例如)超声波探针。超声波探针(优选是手持式的)可应用于软骨且可测量出软骨和/或软骨下骨的曲率。另外,可评估软骨缺损的尺寸并可确定关节软骨的厚度。可在A模式、B模式或C模式中获得此类超声波测量。如果获得A模式的测量,那么操作员通常可以以若干不同的探针方向(例如,内外和前后)重复测量,以得出尺寸、曲率和厚度的三维评估。
所属领域的技术人员将不难发现,使用光学、激光干涉仪、机械和超声波探针可使不同的探针方案成为可能。探针优选是手持式的。在某些实施例中,探针或探针的至少一部分(通常是与组织相接触的部分)是无菌的。使用无菌盖(sterile cover)可实现无菌性,例如类似于1999年2月25日公开的Lang的WO 99/08598A1中所揭示的。
使用影像测试和/或手术中测量而进行的关于关节软骨或软骨下骨曲率的分析可用于确定患病的软骨区域或软骨缺失区域的尺寸。例如,曲率在软骨缺失的区域中可突然发生改变。曲率的这种突然或意外改变可用于检测患病软骨或软骨缺损的边界。
II.关节软骨、骨骼和半月板的分割
己基于活线(live wire)算法实施了半自动分割方法,其提供高度的屈曲度,且因此具有显著改良关节炎软骨的分割的潜力。利用一非线性扩散过滤器选择性地对图像进行预处理。活线算法对图像中的两个像素之间的每个定向边缘(边界元素-bel)分配一列特征。使用每一特征的个别成本函数,将特征值转换成成本值。通过预定的加权方案将每一特征的成本加起来,为每个bel b产生一在0与1之间的单个关节成本值,bel b表示b为软骨边界的一部分的可能性。为了确定软骨对象的轮廓,操作员选择一起始像素P。接着,系统使用动态编程方案计算从每个图像像素到P的最少成本bel路径。当操作员选择另一像素时,系统实时显示从当前鼠标位置到P的计算路径。操作员可将此当前路径冷冻为软骨轮廓的部分。这样,操作员必须集合若干块中的每一片的所要轮廓(“笔划(stroke)”)。
此分割技术所使用的bel b的特征在于b左右的灰度值和b上的灰度级梯度量值。
所属领域技术人员将了解,所述的分割过程的全部或一部分可按需要自动化。所属领域技术人员将了解,可使用其它分割技术,包括(但不限于)阀值处理、灰度级梯度技术、蛇形(snakes)、基于模型的分割、分水岭、群集(clustering)、统计分割、过滤,包括线性分散过滤。
III.软骨表面分割的确认
为了验证关节软骨表面分割技术的精确性,可将从MRI扫描提取出的软骨表面与由(例如)在样本解剖之后使用激光扫描仪所获得的关节表面数据分割得出的结果进行比较。可使用最近点迭代方法来配准由MRI和激光扫描获得的两个表面,且MRI表面上的每一点到所配准的激光扫描表面的距离可用于确定MRI分割结果的精确性。图5显示配准前和配准后的MRI和数字化表面。表1中展示两类样本的距离测量。
表1
在分割的MRI与激光数字化表面之间的距离计算(单位为mm)
样本 | 最小距离 | 最大距离 | 平均距离M | 标准偏差σ |
1 | 3.60447e-05 | 2.10894 | 0.325663 | 0.312803 |
2 | 2.79092e-06 | 1.616828 | 0.26213l | 0.234424 |
在此实例中,数据说明:分割的MRI表面和激光扫描表面之间的平均误差在MRI扫描的分辨率的范围内。因此,所述分割方法产生了在给定MRI扫描参数内的精确性。
IV.软骨厚度分布的计算和显象
计算软骨厚度的适当方法是基于3D欧几里得距离转换(EDT)。Saito和Toriwaki的算法可用于实现非常快的计算(在SGI O2上256×256×60的数据集合的处理时间小于10秒)的数据处理。该算法通过将计算分解成一系列3次一维变换来起作用且利用了实际距离的平方。此过程通过避免确定平方根而加速了分析。初始化时,对内部软骨表面(ICS)上的三维像素(voxel)给定0值,而将所有其它三维像素(包括外部软骨表面(OCS)上的三维像素)设置为1。
首先,对于二进制输入图像F={fijk}(1≤i≤L,1≤j≤M,1≤k≤N),使用方程式1(α、β和γ表示三维像素的维度)得到新的图像G={gijk}。
因此,为每个点分配一个到i方向的相同行中最近特征点的距离的平方值。其次,使用方程式2将G转换成H={hijk}。
算法搜索在j方向中的每一列。根据毕达哥拉斯(Pythagorean)定理,相同栏中点(i,j,k)与点(i,y,k)之间的距离的平方(β(j-y))2与(i,y,k)与特定特征点giyk之间的距离的平方和等于点(i,j,k)与所述特征点之间的距离的平方。该等总和的最小值为(i,j,k)与二维i-j平面中的最近特征点之间的距离的平方。
通过方程式3增加第三维,其为针对k方向上的如方程式2所述的相同的变换。
完成EDT之后,OCS上的一给定点(a,b,c)的软骨的厚度等于Sabc的平方根。此产生一个垂直于ICS而确定的真实的三维距离值。将沿骨骼软骨边界定位的每个像素的x、y、和z位置配准到3D图上,且将厚度值转换成颜色值。以此方式,骨骼软骨界面处的每一像素的解剖位置可同时与给定位置的软骨厚度一起显示(图6)。
所属领域的技术人员将了解,可在不背离本发明的范畴的情况下,应用其它用于计算软骨厚度的技术,例如使用拉普拉斯(LaPlace)方程式。
V.软骨曲率分布的计算和显象
分析关节软骨表面的另一相关参数为曲率。以类似于厚度图的方式,可由从MRI提取的软骨表面数据得出一组曲率图。
基于子取样方案将局部的双三次曲面片拟合到软骨表面,在所述方案中,每个其它表面点是用于产生5×5点元素的网格。因此,在执行拟合之前减少数据的密度,以便拟合表面光滑并减少计算复杂性。
在计算了局部双三次曲面拟合之后,从曲面拟合数据隐含地估算单位法向量{n}。然后由下式给出对应的曲率和其方向:
k1=arccos(n0·ni)/dsi=dθ/ds1
其中,n0为估算曲率的点(u,v)处的单位法向量,且ni(i=1,...,24)为5×5的局部曲面片中的周围点中的每个点处的单位法向量。图6展示最大主要曲率图(值和方向)的实例,使用双三次曲面片拟合方法估算所述曲率。所属领域的技术人员将了解,可应用诸如n-度多项式表面内插或近似、参数表面内插或近似和用于测量曲率或3D形状的不同的离散曲率估计方法等其它技术。
VI.多个平面的图像数据的融合
近来,已开发了能够获得各向同性的或近各向同性的三维图像数据的技术。然而,以比平面内分辨率大3倍或更多的切片厚度仍可获得大多数MRI扫描。此导致对3D图像分析和显象的限制。三维对象结构不能在所有的三维中以相同的精确性描述。部分体积效应阻碍了在z维中进行比x-y平面内更大程度的解释和测量。
为了解决与非各向同性图像分辨率相关联的问题,在第一平面中取一或一个以上的第一扫描S1。每一第一扫描彼此平行。其后,以定向于第一扫描S1的成像平面取一个或一个以上的第二扫描S2,以使该等平面相交。例如,扫描S1可位于第一平面中,而扫描S2位于一正交于第一平面的平面中。除了正交扫描之外或取代正交扫描,也可在其它平面或方向中获得额外的扫描(例如,S3、S4、…Sn)。S2和任何其它扫描可具有与S1相同的平面内分辨率。任何或所有扫描也可包含足够数量的切片,以覆盖S1的整个视野。在此情形下,可产生两种具有来自相同的3D空间或重叠的3D空间的信息的数据量。
可由所述两个扫描合并数据,以独立地提取每一个扫描中相关的对象。此外,后继的分析可在一个坐标系统中组合所述两种分割的数据集合,如图6中所展示。此项技术有助于画出对象边界的轮廓,所述对象定向于平行于S1的成像平面,但是因此将正交于S2的成像平面。
为了定量测量(例如确定软骨体积),最好是直接将S1和S2组合到第三数据量中。此第三数据量一般为各向同性或近各向同性的,其分辨率对应于S1和S2的平面内分辨率,因此减少了切片之间的部分体积效应(图7)。可首先将S1和S2配准到相同的坐标系统中。如果在相同的一段时间获得两种扫描图片(而在两次扫描之间不移动病人),那么图像标头信息用于获得转换矩阵。否则,应用共同的基于信息的严格配准。将第三数据量的每个三维像素V的灰度值计算如下:
(1)确定V在3D空间中的位置;
(2)确定在此位置处S1和S2中的灰度值;
(3)将所述两个灰度值内插到单个灰度值G中;和
(4)将G分配到V。
作为对两个或两个以上的成像平面的融合的替代方法,可获得具有各向同性或近各向同性的分辨率的数据。举例而言,此可能使用螺旋CT捕捉技术或新颖的MRI脉冲序列,例如3D捕捉技术。所述3D捕捉技术包括3D驱动平衡转换(DEFT)、3D快速自旋回波(FSE)、3D SSFP(稳定态自由旋进)、3D梯度回波(GRE)、3D扰相梯度回波(SPGR)、和3D弹性平衡MR(flexible equilibrium MR,FEMR)技术。可使用脂肪饱和或使用水选择激发来获得图像。尽管在1.0×1.0×1.0和甚至更大的选择环境下可产生满足要求的结构,但是一般需要0.5×0.5×0.5mm或更小的各向同性分辨率。在近各向同性分辨率的情况下,一个和一个以上的平面中的三维像素的维度的变化通常不超过50%。
VII.半月板尺寸的体内测量
通过测量病人的半月板形状和尺寸和通过估计关节软骨的3D几何结构可确定个人化的内插关节造形术系统的尺寸和形状。然而,许多骨关节炎病人磨破了半月板,通常仅有少量的或没有半月板剩余。在这些病人中,可通过获得周围关节表面和结构的测量结果来确定个人化的内插关节造形术系统的形状。
例如,在膝中,可对患病的膝的MR图像中的股骨和胫骨骨骼进行一些测量。为了进行最佳的拟合,植入物的上表面的形状应类似于相应半月板的上表面的形状。骨骼的测量可帮助确定预测半月板尺寸有多好。
图8A为半月板100的轴向图。半月板具有最大前面后部距离1,和最大的内侧外侧距离2。在膝中,半月板补偿前角和后部,其每个具有最大的长度3、5和宽度9、11。骨体本身具有最大的长度4和宽度10,其为病人解剖部位的函数。图8B为图8A中的半月板的矢状图。半月板100具有最大的高度6、8,其与前角和后角的最大高度相关联。图8C为半月板100的冠状图。从所述冠状图可明显地看到骨体具有最大的和最小的高度。
现转向图9A,其展示胫骨110的矢状图。胫骨具有最大的前面后部距离12。图9B为图9A中所展示的胫骨110的冠状图。从矢状图可明显地看到胫骨具有最大的内侧-外侧距离13、从胫骨脊骨到边缘的最大距离14、和宽度15。
胫骨与股骨120匹配,其展示于图10A中的矢状图。股骨具有最大的前面后部距离16和最大的上下距离17。从图10B中所展示的冠状图可明显地看到最大的中侧外侧距离18、从滑车到边缘的距离19、和髁间凹的宽度20。
可为各种测量获得皮尔逊(Pearson)相关系数γ来评估一个变量由另一变量表达得如何好。适当的测量包括(例如)以下的测量:
■内侧(外侧)半月板的前部后部(AP)长度与股骨内侧(外侧)髁的AP长度;
■内侧(外侧)半月板的前部后部(AP)长度与内侧(外侧)胫骨平台的AP长度;
■内侧(外侧)半月板的内侧-外侧(ML)宽度与股骨内侧(侧面)髁的ML宽度;
■内侧(外侧)半月板的内侧-外侧(ML)宽度与内侧(外侧)胫骨平台的ML宽度;
■内侧(外侧)半月板的最高点的y坐标与内侧(外侧)胫骨中心的最高点的y坐标;
■内侧(外侧)半月板的内侧(外侧)边缘的x坐标与股骨内侧(外侧)髁的内侧(外侧)边缘的x坐标;和
■内侧(外侧)半月板的内侧(外侧)边缘的x坐标与内侧(外侧)胫骨平台的内侧(外侧)边缘的x坐标。
在表2中总结所得的测量的实例。
表2
半月板尺寸与股骨和胫骨骨骼尺寸之间的相关性
测量 | 成像平面 | N | 皮尔逊γ |
AP长度:内侧半月板-股骨内侧髁 | 矢状 | 23 | 0.74 |
AP长度:外侧半月板-股骨外侧髁 | 矢状 | 24 | 0.73 |
AP长度:内侧半月板-内侧胫骨平台 | 矢状 | 23 | 0.79 |
AP长度:外侧半月板-外侧胫骨平台 | 矢状 | 24 | 0.27 |
ML宽度:半月板- | 冠状 | 12 | 0.91 |
股骨 | |||
ML宽度:半月板-胫骨 | 冠状 | 12 | 0.92 |
ML宽度:半月板-股骨内侧髁 | 冠状 | 12 | 0.81 |
ML宽度:半月板-股骨外侧髁 | 冠状 | 12 | 0.65 |
ML宽度:半月板-内侧胫骨平台 | 冠状 | 12 | 0.86 |
ML宽度:半月板-外侧胫骨平台 | 冠状 | 12 | 0.48 |
ML宽度:内侧半月板-股骨内侧髁 | 冠状 | 12 | 0.95 |
ML宽度:外侧半月板-股骨外侧髁 | 冠状 | 12 | 0.45 |
ML宽度:内侧半月板-内侧胫骨平台 | 冠状 | 12 | 0.69 |
ML宽度:外侧半月板-外侧胫骨平台 | 冠状 | 12 | 0.34 |
ML长度:内侧半月板-外侧半月板 | 冠状 | 12 | 0.12 |
半月板高度:内侧半月板-外侧半月板 | 冠状 | 12 | 0.01 |
半月板高度:内侧半月板高度-内侧股骨高度 | 冠状 | 12 | 0.22 |
半月板高度:外侧半月板高度-外侧股骨高度 | 冠状 | 12 | 0.22 |
半月板高度:内侧半月板高度-内侧胫骨高度 | 冠状 | 12 | 0.55 |
半月板高度:外侧半月板高度-外侧胫骨高度 | 冠状 | 12 | 0.17 |
最高点(y坐标):内侧半月板-内侧胫骨中心 | 冠状 | 12 | 0.99 |
最高点(y坐标):外侧半月板-外侧胫骨中心 | 冠状 | 12 | 0.90 |
中间边缘(x坐标):内侧半月板-股骨髁 | 冠状 | 12 | 1.00 |
侧面边缘(x坐标):外侧半月板-股骨外 | 冠状 | 12 | 1.00 |
侧髁 | |||
中间边缘(x坐标):内侧半月板-内侧胫骨平台 | 冠状 | 12 | 1.00 |
侧面边缘(x坐标):外侧半月板-外侧胫骨平台 | 冠状 | 12 | 1.00 |
皮尔逊系数确定所测量的两种尺寸之间的关系。相关性越高,两个测量结果之间的关系越好。从表2中的数据可明显看出,在膝中,可通过测量相应的股骨髁的长度可很好地预测内侧和外侧半月板的AP长度。内侧胫骨平台的长度也可用于内侧半月板。股骨内侧髁的ML宽度为内侧半月板的宽度的很好的预测值。内侧和外侧胫骨中心的高度与相应的半月板的高度很好地相关。由于外侧半月板的最外侧点具有高可变性,外侧半月板的ML宽度与股骨外侧髁和胫骨中心的宽度之间的相关性较低。与外侧半月板的最远点相反的是,主边缘与胫骨和股骨的边缘很好地相关。对于内侧半月板也如此。因此,可确定内侧和外侧半月板的外部边缘。
所述结果展示可通过测量MR图像中的骨骼标志可以可靠地预测半月板尺寸。如果皮尔逊系数高(例如,接近1),则所述两个测量结果实际上可交换地用于表示所要的测量结果。如果皮尔逊系数低(例如,0.34),则可将相关因数应用于测量结果。然后,经校正的测量结果可等于或接近对应的测量结果。在某些情况下,可能校正因数的使用是不可行或者不需要的。在此情况下,在不背离本发明的范畴的情况下,可将其它诸如逻辑回归和多元分析等方法作为替代方法。
所属领域的技术人员将了解,尽管此数据已经相对于膝中的半月板和与其相关的膝解剖的测量结果进行陈述,类似的结果也可发生在骨体内的其它关节中。此外,预期可创建一个测量库(例如),以产生一个或一个以上的用于特定关节的相关因数。例如,可使用从不同实验体身上获得的复数个测量结果来产生一单个相关因数。
或者,可基于(例如)所评估的关节、病人的体型、重量、体重指数(body mass index)、年龄、性别、种族背景等产生复数个相关因数。在此情况下,可评估寻求治疗的病人。可对例如股骨内侧髁进行测量。然后,可将病人的股骨内侧髁的相关因数与基于样本的计算得出的相关因数相比较,其中样本病人具有相同的或在预定的因数范围内,包括(例如):尺寸、种类、年龄和性别。
VIII.表面数字化
可使用Titanium FaroAm坐标测量机器(CMM)(FARO Technologies Inc.,LakeMary,FL)获得来自用于产生一般半月板模型的尸体样品的半月板的数字化的表面数据。
IX.用于在解剖上矫正内插关节造形术系统的3D设计技术
每一植入物的设计工作流程可由一个或一个以上的以下步骤的组合组成:
a.融合关节的矢状和冠状3D SPGR或2D或3D FSE数据或其它序列;
b.分割关节软骨表面的点数据;
c.融合关节的矢状和冠状2D或3D FSE或2D SE数据或其它序列;
d.分割半月板上表面的点数据;
e.组合软骨表面数据和半月板表面数据以用作植入物表面的模型;
f.以范围为0.2到0.99的因数压缩半月板表面;
g.将植入物上表面和下表面的点云数据转换成参数表面数据;和
h.切割参数表面数据集合以确定植入物的精确的形状。
然而,许多病人具有严重的骨关节炎,半月板在很大程度上被耗尽了,且因此不可直接用作可得出植入物上表面的模板。在该等情况下,剩余关节骨骼的尺寸可用于调整一般半月板模型的尺寸,然后其可用作植入物的模板。
X.从软骨和健康的半月板表面导出植入物表面
可基于在半月板不覆盖的区域中的半月板上表面和关节软骨表面模制植入物的上表面。因此,在逐片分割来自SE或FSE或其它MRI图像的半月板上表面和来自3D DPGR或FSE或其它MRI图像的胫骨软骨表面之后,将组合两种数据集合(图11A-C)。为了确定假体的合成的表面,定位两个表面之间的交叉。在两个表面在特殊分层中不交叉的情况中,将计算穿过半月板表面与筋骨表面的中心端的切线之间的交叉(图11A)。为了解决在负载情况下的弹性半月板的自然压缩,可将其高度调整到(例如)原始高度的60%(图11B)。为此目的,将半月板表面上每一点连接到软骨表面上的最近点。经调整的半月板表面的新点选择在离胫骨软骨表面的距离的60%处。
所属领域的技术人员将了解,可在不背离本发明的范畴的情况下使用各种其它调整比例。适当的调整比例随病人的生理学和所要的矫正度而不同,且包括(例如)范围为0.2到1.5的比例。相对于自然半月板的植入物高度调整的数量将随制造植入物的材料而不同。例如,如果是由具有高度弹性的材料制造的植入物,则可需要使用大于1的调整。如果材料具有低度弹性,则调整适合接近50%。适当的调整也将取决于制造所述植入物所针对的关节。因此。例如,针对膝制造的使用具有低度弹性的材料的植入物可具有50-70%的调整,而为针对肩制造的也使用具有低度弹性的材料的植入物可具有60-80%的所要的调整。所属领域的技术人员将了解,植入物的矫正因数随目标关节和制造植入物的材料的特性而变化。
调整比例也可随关节内的位置而不同,其具有对于任何给定设计而言可能的复数个比例。例如,在膝关节中,可在前面使用接近0.8的调整比例,而在后部使用接近0.5的调整比例。另外,可选择更多的调整比例,使得调整比例取决于预期的关节生物力学(例如,前面的)而逐渐改变。也可由于病人的特殊参数来对调整比例做改变,所述参数诸如年龄、性别、重量、种族、和活动水平。可选择调整比例以达到最佳生物机械或功能结果。试管内尸体测试,约束测试、接触表面测试、疲劳测试和机器人专家测试可(例如)用于为植入物确定最佳调整比例。
最后,为了确定植入物上表面的形状,可将压缩的半月板表面与未经半月板覆盖的胫骨软骨表面的部分组合。可由整个软骨表面(图11C)或软骨下骨表面得出植入物的(例如)下表面的形状。(例如)如果存在严重的关节骨质象牙化并大多数软骨已经缺失,那么可使用后者。
XI.在损坏半月板的情况导出植入物上表面
病人具有损坏的或退化的半月板或先前已进行了半月板切除术时,半月板表面不可用作上述的植入物表面的模板。在这些情况下,一般半月板模型(generic meniscal model)可用于设计所要的植入物表面。
举例而言,可由使用上述的Titanium FaroAm从尸体股骨样品中收集的数据产生一般半月板模型。或者,可使用激光扫描装置或光学装置。在这种情况下,可(例如)由十个冷冻的尸体胫骨样品数字化半月板表面数据。然后,可使用(例如)仿射曲面定位方案来针对尺寸差异匹配所获得的所有的表面数据集合。然后,可将定位之后的经匹配的编码点合并到一单个点云中。可使用最小平方优化通过点云来拟合一般半月板表面Sg,得出十个样品的“平均”表面。
通常,健康的半月板的尺寸与骨骼标志的尺寸很好地相关。因此,MRI中的骨骼标志的测量可用于重建健康的半月板的尺寸(见,例如上表2)。将由股骨髁的长度计算前部后部长度L。为了确定内侧-外侧半月板宽度W,我们可为内侧半月板使用胫骨的中间边缘的位置且为外侧半月板使用侧面胫骨边缘。可从胫骨中心的最高点导出高度H。
一旦已确定了值L、W、和H,就可相应地使Sg变形。可使用方程式4将Sg中的坐标为(x,y,z)每一点P转换成新的点P’:
其中,Lg、Wg、和Hg为Sg的个别维度。经转换的点P’可形成将用作用于设计如先前章节中所描述的植入物上表面的模板的半月板表面S。
XII.植入物设计的最终步骤
如以上所描述的由MR图像导出的第一和第二植入物表面由点云组成。会将点云转换成然后可在(例如)CAD系统中操作的数据格式。表面建模程序Rhinoceros中的曲面片函数可用于使光滑的曲面片接近于点云数据(图12)。然后,可以IGES格式输出此表面以由CAD软件读取。在不背离本发明的范畴的情况下可使用其它软件程序。例如,Pro/Engineer、Solid Edge、Alibre和IronCAD也为适当的程序。
使用CAD软件SolidWorks,可将上表面和下表面组合成一个设计模型。可将外部的半月板边缘用作一边缘来缩略两个表面(图11)。
由此信息可考虑所述尺寸设计关节植入物。图13A和B为适合于在股骨髁上使用的关节植入物的图。从下表面和上表面观察点展示所述图。可调整植入物的表面、边缘和高度以说明所取得的测量结果来达到最适合病人的植入物。图14为适合于放置于膝关节中并放置于胫骨平台的一部分上的植入物的图。图15A-D为适合于髋的植入物的图。也可设计所述植入物使得可调整植入物的表面、边缘和高度以说明所取的测量以及病人的的特殊标准为适当的或需要。
XIII.用于导出植入物的3D形状的3D成像和3D量尺寸技术的精确性
为了确定从一般模型计算的预测的半月板表面与半月板的实际形状有多不同,可检查健康的自愿者。可获得也具有静脉内或关节内的对比增强的适当的螺旋CT或MRI图像,然后可使用活线分割或其它适当的机构从所述螺旋CT或MRI图像中提取内侧和外侧半月板。此外,可如以上所描述拟合内侧和外侧半月板的一般模型。对于每一实验体而言,可从MRI分割的内侧和外侧半月板可与拟合的模型相比较如下:
1.为分割的数据集合中的每一点P=(x,y,z)从拟合模型中选择最近点P1=(x1,y1,z1)和两个最近点P2=(x2,y2,z2)和P3=(x3,y3,z3),其中z1≥z,z2,z3≤z。
2.将点P正交地投影到由P1、P2和P3界定的平面上。经投影的点P’由下式给出:
其中,n为平面的法线且(·,·)表示点积。
3.按下式计算点P到平面的距离d1:
i.d1=‖P′-P‖。
4.重复步骤1-3,其中P1=(x1,y1,z1)、P2=(x2,y2,z2)和P3=(x3,y3,z3),使z1≤z,z2,z3≥z,得出d2。
5.为P计算平均距离:d(P)=(d1+d2)/2。
6.在分割的数据集合中的所有点上计算总的距离测量D:
总的距离测量D取决于坐标系统中的分割的MRI数据和拟合的模型的相对位置。通过调整刚性骨体转换T可优化此相对位置来最小化D,其基于最近点迭代算法使用D(T)作为成本函数在迭代定位程序中定位模型。
一般地,如果平均距离D/n低于1.5mm,那么预期这个拟合方法的精确性足够了,其中n为分割数据中的点的数量。
虽然已提供了本发明的实施例的前述描述用于说明和描述的目的,但并非详尽的且不欲将本发明限制于所揭示的精确形式。对于所属领域的技术人员而言,许多修改和变化都是显而易见的。选择并描述所述实施例以最好地解释本发明的原则和其实际应用,由此使所属领域的其它技术人员能够理解本发明和多种实施例并进行适合于预期的特殊使用的多种修改。本发明的范畴将由随附的权利要求书和其均等物来界定。
Claims (97)
1.一种治疗关节中的缺损的方法,其包括:
获得一关节的图像;和
生成厚度图和曲率图中的至少一个。
2.根据权利要求1所述的方法,其还包括以下一个或一个以上步骤:
使用一非线性扩散滤波器预先处理所获得的图像;
向位于至少两个像素边界之间的每个定向边缘分配一列特征;
将所述特征转换成成本价值;和
计算一单个成本价值。
3.根据权利要求2所述的方法,其还包括以下步骤:
确定一成本价值成为软骨边界的一部分的可能性。
4.根据权利要求1和3所述的方法,其还包括以下步骤:
通过选择至少一第一像素和一第二像素确定一软骨对象的轮廓。
5.根据权利要求4所述的方法,其中所述第一像素和所述第二像素是自动选择的。
6.根据权利要求4所述的方法,其中所述第一像素和所述第二像素是由操作员选择的。
7.根据权利要求1所述的方法,其还包括计算软骨厚度的步骤。
8.根据权利要求7所述的方法,其中使用3D欧几里德转换(Euclidean Transform)执行所述计算软骨厚度的步骤。
9.根据权利要求7所述的方法,其中通过将所述计算分解成一系列三次一维转换来执行所述计算软骨厚度的步骤。
10.根据权利要求9所述的方法,其中还对所述一维转换求平方以获得一组距离。
11.根据权利要求8所述的方法,其中根据Sabc的平方根计算外软骨表面上的某点的软骨厚度。
12.根据权利要求1所述的方法,其中从所述生成的厚度图设计一植入物。
13.根据权利要求1所述的方法,其中所述缺损是软骨疾病、骨骼损坏、外伤和退化中的至少一个原因而导致的结果。
14.根据权利要求9、11和12所述的方法,其中所述厚度是一测量厚度且用于设计一植入物以用于治疗所述关节中的所述缺损。
15.根据权利要求14所述的方法,其中根据所选择用来制造所述植入物的材料的质量在至少一部分所述植入物上调节所述测量厚度。
16.根据权利要求15所述的方法,其中在至少一部分所述植入物上以所述测量厚度的0.2到1.5的系数将所述测量厚度调节成一最终植入物厚度。。
17.一种适用于治疗关节中的缺损的植入物,其中所述植入物通过以下步骤来设计:
获得一关节的图像;和
生成厚度图和曲率图中的至少一个。
18.根据权利要求17所述的方法,其还包括一个或一个以上以下步骤:
使用一非线性扩散滤波器处理所获得的图像;
向位于至少两个像素边界之间的每个定向边缘分配一列特征;
将所述特征转换成成本价值;和
计算一单个成本价值。
19.根据权利要求18所述的方法,其还包括以下步骤:
确定成本价值成为一部分软骨边界的可能性。
20.根据权利要求17和18所述的方法,其还包括以下步骤:
通过选择至少一第一像素和一第二像素确定一软骨对象的轮廓。
21.根据权利要求20所述的方法,其中所述第一像素和所述第二像素是自动选择的。
22.根据权利要求20所述的方法,其中所述第一像素和所述第二像素是由操作员选择的。
23.根据权利要求17所述的方法,其还包括计算软骨厚度的步骤。
24.根据权利要求23所述的方法,其中使用3D欧几里德转换执行所述计算软骨厚度的步骤。
25.根据权利要求23所述的方法,其中通过将所述计算分解成一系列三个一维转换而执行所述计算软骨厚度的步骤。
26.根据权利要求25所述的方法,其中还对所述一维转换求平方以获得一组距离。
27.根据权利要求24所述的方法,其中根据Sabc的平方根计算外软骨表面上的某点的软骨厚度。
28.根据权利要求17所述的方法,其中所述缺损是软骨疾病、骨骼损坏、外伤和退化中的至少一个原因而导致的结果。
29.根据权利要求25、27和28所述的方法,其中所述厚度是一测量厚度且用于设计一植入物以用于治疗所述关节中的所述缺损。
30.根据权利要求29所述的方法,其中根据所选择用来制造所述植入物的材料的质量在至少一部分所述植入物上调节所述测量厚度。
31.根据权利要求29所述的方法,其中在至少一部分所述植入物上以所述测量厚度的0.2到1.5的系数将所述测量厚度调节成一最终植入物厚度。
32.一种治疗关节中的缺损的方法,其包括:
获得一关节的图像;
使用一非线性扩散滤波器处理所获得的图像;和
生成一软骨曲线。
33.根据权利要求32所述的方法,其还包括以下步骤:
使局部的双三次曲面片符合所述软骨曲线。
34.根据权利要求32所述的方法,其中所述双三次曲面片是自动选择的。
35.根据权利要求32所述的方法,其中所述双三次曲面片是由操作员选择的。
36.根据权利要求32所述的方法,其还包括计算软骨厚度的步骤。
37.根据权利要求36所述的方法,其中使用3D欧几里德转换执行所述计算软骨厚度的步骤。
38.根据权利要求36所述的方法,其中通过将所述计算分解成一系列三个一维转换而执行所述计算软骨厚度的步骤。
39.根据权利要求38所述的方法,其中还对所述一维转换求平方以获得一组距离。
40.根据权利要求37所述的方法,其中根据Sabc的平方根计算外软骨表面上的某点的软骨厚度。
41.根据权利要求32所述的方法,其中还从所述软骨曲线设计一植入物。
42.根据权利要求38、40和41所述的方法,其中所述厚度是一测量厚度且用于设计一植入物以用于治疗所述关节中的所述缺损。
43.根据权利要求42所述的方法,其中根据所选择用来制造所述植入物的材料的质量在至少一部分所述植入物上调节所述测量厚度。
44.根据权利要求42所述的方法,其中在至少一部分所述植入物上以所述测量厚度的0.2到1.5的系数将所述测量厚度调节成一最终植入物厚度。
45.一种用于纠正关节中的缺损的植入物,其中根据所述关节内的至少一个软骨和骨骼标志的测量通过估计半月板尺寸来确定所述植入物的大小。
46.根据权利要求45所述的植入物,其中所述关节是膝关节。
47.根据权利要求46所述的植入物,其中所述测量是选自由以下测量组成的组:内侧半月板的长度;股骨内侧髁的长度;外侧半月板的长度;股骨外侧髁的长度;内侧胫骨平台的长度;外侧胫骨平台的长度;内侧半月板的宽度;股骨内侧髁的宽度;外侧半月板的宽度;股骨外侧髁的宽度;内侧胫骨平台的宽度;外侧胫骨平台的宽度;内侧半月板的最高点;内侧胫骨脊骨的最高点;外侧半月板的最高点;外侧胫骨脊骨的最高点;股骨髁的最高点;和股骨外侧髁的最高点、软骨厚度和软骨曲率和3D软骨形状。
48.根据权利要求45所述的植入物,其中所述关节是一踝关节。
49.根据权利要求48所述的植入物,其中所述测量是选自由以下测量组成的组:距骨的直径、距骨的长度、距骨的宽度、距骨的曲率、距骨的软骨厚度、距骨的软骨下骨厚度、跟骨的直径、跟骨的长度、跟骨的宽度、跟骨的曲率、跟骨的软骨厚度、跟骨的软骨下骨厚度。
50.根据权利要求45所述的植入物,其中所述关节是一髋关节。
51.根据权利要求50所述的植入物,其中所述测量是选自由以下测量组成的组:髋臼的内外直径(mediolateral diameter);髋臼的前后直径;髋臼的上下直径;髋臼前部的、后部的、上部的、下部的、内侧的或外侧的曲率;髋臼前部的、后部的、上部的、下部的、内侧的或外侧的关节软骨的厚度;髋臼前部的、后部的、上部的、下部的、内侧的或外侧的软骨下骨的厚度;股骨头的内外直径;股骨头的前后直径;股骨头的上下直径;股骨头前部的、后部的、上部的、下部的、内侧的或外侧的曲率;股骨头前部的、后部的、上部的、下部的、内侧的或外侧的关节软骨的厚度;股骨头前部的、后部的、上部的、下部的、内侧的或外侧的软骨下骨的厚度。
52.根据权利要求45所述的植入物,其中所述关节是一肩关节。
53.根据权利要求52所述的植入物,其中所述测量是选自由以下测量组成的组:关节窝的内外直径、关节窝的前后直径、关节窝的上下直径、关节窝前部的、后部的、上部的、下部的、内侧的或外侧的曲率、关节窝前部的、后部的、上部的、下部的、内侧的或外侧的关节软骨的厚度、关节窝前部的、后部的、上部的、下部的、内侧的或外侧的软骨下骨的厚度、肱骨头的内外直径、肱骨头的前后直径、肱骨头的上下直径、肱骨头前部的、后部的、上部的、下部的、内侧的或外侧的曲率、肱骨头前部的、后部的、上部的、下部的、内侧的或外侧的关节软骨的厚度、肱骨头前部的、后部的、上部的、下部的、内侧的或外侧的软骨下骨的厚度。
54.根据权利要求45所述的植入物,其中所述关节是一肘关节。
55.根据权利要求54所述的植入物,其中所述测量是选自由以下测量组成的组:肱骨远端的直径、肱骨远端的深度、肱骨远端的宽度、肱骨远端的曲率、肱骨远端的软骨厚度、肱骨远端的软骨下骨厚度、桡骨的直径、桡骨的深度、桡骨的宽度、桡骨的曲率、桡骨的软骨厚度、桡骨的软骨下骨厚度、尺骨的直径、尺骨的深度、尺骨的宽度、尺骨的曲率、尺骨的软骨厚度、尺骨的软骨下骨厚度。
56.根据权利要求45所述的植入物,其中所述关节是一腕关节。
57.根据权利要求56所述的植入物,其中所述测量是选自由以下测量组成的组:桡骨的直径、桡骨的深度、桡骨的宽度、桡骨的曲率、桡骨的软骨厚度、桡骨的软骨下骨厚度、尺骨的直径、尺骨的深度、尺骨的宽度、尺骨的曲率、尺骨的软骨厚度、尺骨的软骨下骨厚度、近排腕骨的直径、近排腕骨的深度、近排腕骨的宽度、近排腕骨的曲率、近排腕骨的软骨厚度、近排腕骨的软骨下骨厚度、舟骨或月骨的直径、舟骨或月骨的深度、舟骨或月骨的宽度、舟骨或月骨的曲率、舟骨或月骨的软骨厚度、舟骨或月骨的软骨下骨厚度、三角纤维软骨的直径、三角纤维软骨的深度、三角纤维软骨的宽度、三角纤维软骨的曲率、三角纤维软骨的厚度。
58.根据权利要求45所述的植入物,其中所述关节是一指关节。
59.根据权利要求59所述的植入物,其中所述测量是选自由以下测量组成的组:指骨或掌骨的深度、指骨或掌骨的宽度、指骨或掌骨的直径、指骨或掌骨的曲率、指骨或掌骨的软骨厚度、指骨或掌骨的软骨下骨厚度。
60.根据权利要求45所述的植入物,其中所述关节在所述脊骨中。
61.根据权利要求60所述的植入物,其中所述测量是选自由以下测量组成的组:前后椎骨尺寸、内外椎骨尺寸、椎体前部的、中间的或后部的高度、茎的直径、茎的宽度、茎的长度、小关节的直径或半径、小关节的体积、小关节的3D形状、小关节的曲率、后部元件的尺寸、脊椎管的尺寸、椎体的3D形状。
62.一种用于治疗关节的植入物,其中根据所述关节内的软骨和骨骼标志的测量通过估计关节尺寸来确定所述植入物的大小。
63.一种用于设计关节的解剖学上纠正插入型关节造形系统的技术,其包括以下步骤:
获得关节的软骨或骨骼表面的数据;
获得一个或一个以上半月板表面的数据;
结合软骨或肱骨表面数据和半月板表面数据。
64.根据权利要求63所述的方法,其中现有骨骼关节的数据是用于调节半月板模型的大小。
65.一种治疗关节中的缺损的方法,其包括:
获得一关节的图像;和
测量曲率和厚度中的至少一个。
66.根据权利要求65所述的方法,其还包括一个或一个以上的以下步骤:
使用一非线性扩散滤波器预先处理所获得的图像;
对位于至少两个像素边界之间的每个定向边缘分配一列特征;
将所述特征转换成成本价值;和
计算一单个成本价值。
67.根据权利要求66所述的方法,其还包括以下步骤:
确定成本价值成为一部分软骨边界的可能性。
68.根据权利要求65和67所述的方法,其还包括以下步骤:
通过选择至少一第一像素和一第二像素确定一软骨对象的轮廓。
69.根据权利要求68所述的方法,其中所述第一像素和所述第二像素是自动选择的。
70.根据权利要求68所述的方法,其中所述第一像素和所述第二像素是由操作员选择的。
71.根据权利要求65所述的方法,其中还包括通过计算软骨厚度执行测量厚度的步骤。
72.根据权利要求71所述的方法,其中使用3D欧几里德转换执行所述计算软骨厚度的步骤。
73.根据权利要求71所述的方法,其中通过将所述计算分解成一系列三个一维转换而执行所述计算软骨厚度的步骤。
74.根据权利要求73所述的方法,其中还对所述一维转换求平方以获得一组距离。
75.根据权利要求72所述的方法,其中根据Sabc的平方根计算外软骨表面上的某点的软骨厚度。
76.根据权利要求65所述的方法,其中还从曲率和厚度中的至少一个的测量来设计植入物。
77.根据权利要求65所述的方法,其中所述缺损是软骨疾病、骨骼损坏、外伤和退化中的至少一个原因而导致的结果。
78.根据权利要求73、75和76所述的方法,其中所述厚度是一测量厚度且用于设计植入物以用于治疗所述关节中的所述缺损。
79.根据权利要求78所述的方法,其中根据所选择用来制造所述植入物的材料的质量在至少一部分所述植入物上调节所述测量厚度。
80.根据权利要求79所述的方法,其中在至少一部分所述植入物上以所述测量厚度的0.2到1.5的系数将所述测量厚度调节成一最终植入物厚度。
81.一种适用于治疗关节中的缺损的植入物,其中所述植入物通过以下步骤来设计:
获得一关节的图像;和
测量曲率和厚度中的至少一个。
82.根据权利要求81所述的方法,其还包括一个或一个以上的以下步骤:
使用一非线性扩散滤波器处理所获得的图像;
对位于至少两个像素边界之间的每个定向边缘分配一列特征;
将所述特征转换成成本价值;和
计算一单个成本价值。
83.根据权利要求82所述的方法,其还包括以下步骤:
确定成本价值成为一部分软骨边界的可能性。
84.根据权利要求81和82所述的方法,其还包括以下步骤:
通过选择至少一第一像素和一第二像素来确定一软骨对象的轮廓。
85.根据权利要求84所述的方法,其中所述第一像素和所述第二像素是自动选择的。
86.根据权利要求84所述的方法,其中所述第一像素和所述第二像素是由操作员选择的。
87.根据权利要求81所述的方法,其还包括计算软骨厚度的步骤。
88.根据权利要求87所述的方法,其中使用3D欧几里德转换执行所述计算软骨厚度的步骤。
89.根据权利要求87所述的方法,其中通过将所述计算分解成一系列三个一维转换而执行所述计算软骨厚度的步骤。
90.根据权利要求89所述的方法,其中还对所述一维转换求平方以获得一组距离。
91.根据权利要求88所述的方法,其中根据Sabc的平方根计算外软骨表面上的某点的软骨厚度。
92.根据权利要求81所述的方法,其中所述缺损是软骨疾病、骨骼损坏、外伤和退化中的至少一个原因而导致的结果。
93.根据权利要求89、91和92所述的方法,其中所述厚度是一测量厚度且用于设计一植入物以用于治疗所述关节中的所述缺损。
94.根据权利要求93所述的方法,其中根据所选择用来制造所述植入物的材料的质量在至少一部分所述植入物上调节所述测量厚度。
95.根据权利要求93所述的方法,其中在至少一部分所述植入物上以所述测量厚度的0.2到1.5的系数将所述测量厚度调节成一最终植入物厚度。
96.一种用于矫正关节缺损的植入物,其中所述植入物大小是通过根据厚度和曲度中的至少一个的测量结果估计半月板尺寸而判定的。
97.一种用于矫正关节缺损的植入物,其中所述植入物大小是根据厚度图和曲度图中的至少一个的测量结果估计半月板尺寸而判定的。
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CN102652685A (zh) * | 2007-09-30 | 2012-09-05 | 德普伊产品公司 | 定制的患者专用整形外科手术器械 |
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EP3075356A1 (en) | 2016-10-05 |
US20150216615A1 (en) | 2015-08-06 |
US20100303317A1 (en) | 2010-12-02 |
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US20120093377A1 (en) | 2012-04-19 |
CA2505371A1 (en) | 2004-05-27 |
US7796791B2 (en) | 2010-09-14 |
AU2003290757A1 (en) | 2004-06-03 |
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US8932363B2 (en) | 2015-01-13 |
US8965088B2 (en) | 2015-02-24 |
US20140153798A1 (en) | 2014-06-05 |
JP2006505366A (ja) | 2006-02-16 |
EP3075356B1 (en) | 2023-07-05 |
EP1558181A1 (en) | 2005-08-03 |
WO2004043305A1 (en) | 2004-05-27 |
US20040147927A1 (en) | 2004-07-29 |
HK1072888A1 (zh) | 2005-09-16 |
US20040153079A1 (en) | 2004-08-05 |
EP1558181B1 (en) | 2015-08-26 |
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