CN1913844B - 患者选择性膝关节成形装置 - Google Patents

患者选择性膝关节成形装置 Download PDF

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CN1913844B
CN1913844B CN2004800397472A CN200480039747A CN1913844B CN 1913844 B CN1913844 B CN 1913844B CN 2004800397472 A CN2004800397472 A CN 2004800397472A CN 200480039747 A CN200480039747 A CN 200480039747A CN 1913844 B CN1913844 B CN 1913844B
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Prior art keywords
implant
femur
condyle
joint
bone
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CN1913844A (zh
Inventor
艾伯特G·Jr.·布尔杜利斯
沃尔夫冈·菲茨
菲利普·兰
丹尼尔·施泰内斯
康斯坦丁诺斯·楚加拉基斯
勒内·沃拉切克·瓦尔加斯
哈桑·布阿迪
安妮·赛西莉·奥里甘
戴维·米勒
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Imaging Therapeutics Inc
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Imaging Therapeutics Inc
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Priority claimed from US10/752,438 external-priority patent/US8545569B2/en
Application filed by Imaging Therapeutics Inc filed Critical Imaging Therapeutics Inc
Priority to CN201510757327.8A priority Critical patent/CN105287049B/zh
Priority to CN201210270152.4A priority patent/CN102805677B/zh
Publication of CN1913844A publication Critical patent/CN1913844A/zh
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Abstract

本文公开用于修复膝关节中关节表面的方法和装置。所述关节表面修复对于各患者是可定制的或者是高度选择性的并适合提供最佳适合和功能。也提供套组以使得能够进行定制的修复。

Description

患者选择性膝关节成形装置
技术领域
本发明是关于整形外科的方法、系统和装置,且更确切地说是关于膝中关节表面重塑的方法、系统和装置。
背景技术
存在各种类型的软骨,例如透明软骨和纤维软骨。透明软骨发现于例如关节中的骨的关节表面,且负责提供活动关节的平滑滑移运动特征。在人类关节中关节软骨牢固连接于基底骨且测量通常小于5毫米厚,而根据关节和关节内的位置变化相当大。
成人软骨具有有限的修复能力,因此,由诸如风湿病及/或骨关节炎的疾病或者创伤产生的对软骨的损坏可导致严重的身体畸形和衰弱。另外,伴随人类关节软骨老化,其张力特性改变。膝关节软骨的表面区展现张力强度增加直至一生的十分之三,之后随着年龄增加在关节表面出现对11型胶原蛋白的可检测损害,其显著降低。深区软骨随着年龄增加也展现张力强度逐渐降低,尽管胶原蛋白含量未表现出减少。此等观察结果说明随着年龄增加软骨的机械和因而的结构组织存在改变,如果发展充分,则其可使软骨易于受到创伤损坏。
一旦损坏发生,则关节修复可通过多种方法解决。一种方法包括使用基质、组织支架或者其他植入细胞(例如成软骨细胞、成软骨祖细胞、基质细胞、间质干细胞等)的载体。此等解决方法描述为对软骨和半月板修复或者替换的可能的治疗方法。也参见公开于1999年十月14日的Fofonoff的国际公开案WO99/51719;公开于12/6/2001的Simon等人的WO01/91672;和公开于2001年三月15日Mannsmann的WO01/17463;2001年九月4日授予Vibe-Hansen等人的美国专利第6,283,980B1号,1998年十二月1日授予Naughton的美国专利第5,842,477号,1998年六月23日授予Schwartz等人的美国专利第5,769,899号,1986年九月2日授予Caplan等人的美国专利第4,609,551号,1991年八月29日授予Vacanti等人的美国专利第5,041,138号,1993年三月30日授予Caplan等人的美国专利第5,197,985号,1993年七月13日授予Caplan等人的美国专利第5,226,914号,2001年十二月11日授予Hardwick等人的美国专利第No.6,328,765号,2001年八月28日授予Rueger等人的美国专利第6,281,195号和1989年七月11日授予Grand的美国专利第4,846,835号。但是,利用诸如异体移植和自体移植系统的生物替换材料以及组织支架的临床结果并不确定,因为此等材料未能实现形态排列或者结构类似于或者等同于其意欲替换的正常无疾病人类组织。而且,此等生物替换材料的机械耐久性仍不确定。
通常,软骨的严重损坏和丢失通过利用例如(例如用于美容修复的)硅树脂或者金属合金的假体材料替换关节来治疗。参见例如2002年五月7日授予Schmotzer的美国专利第6,383,228号;2001年三月20日授予Afriat等人的美国专利第6,203,576号;2000年十月3日授予Ateshian等人的美国专利第6,126,690号。植入此等假体装置通常伴以基底组织和未恢复由原始软骨提供的全部功能的骨的丢失,且在一些装置的情况下,与大量组织和骨丢失相关的严重长期并发症可包括感染、骨质溶解且也包括植入物的松动。
另外,关节成形术是高度侵入性的且要求外科切除一个或一个以上骨的全部关节表面或者其大部分。在此等程序中,通常扩大髓腔空间以适合假体的茎干。扩孔导致患者骨存量丢失。1997年一月14日授予Scott等人的美国专利5,593,450公开一种卵圆形髌骨假体。所述假体具有一个包括两个作为接合表面的髁的股骨组件。所述两个髁符合以形成一个第二滑车槽并依附于接合于股骨组件的胫骨组件上。提供一个髌骨组件以啮合所述滑车槽。2000年七月18日授予Letot等人的美国专利6,090,144公开一种包括一个胫骨组件和一个适于通过不对称啮合而与所述胫骨组件啮合的半月板组件的膝假体。
多种材料可用于以假体替换关节,例如(例如用于美容修复的)硅树脂或者合适的金属合金是适当的。参见例如,2002年九月3日授予Running的美国专利第6,443,991B1号,2002年五月14日授予Miehlke等人的美国专利第6,387,131B1号,2002年五月7日授予Schmotzer的美国专利第6,383,228号,2002年二月5日授予Krakovits等人的美国专利第6,344,059B1号,2001年三月20日授予Afriat等人的美国专利第6,203,576号,2000年十月3日授予Ateshian等人的美国专利第6,126,690号,2000年一月11日授予Kaufman等人的美国专利第6,013,103号。植入此等修复性装置通常伴以基底组织和未恢复由原始软骨提供的全部功能的骨的丢失,且在一些装置的情况下,与大量组织和骨丢失相关的严重长期并发症可引起植入物的松动。一种此类并发症是骨质溶解。一旦所述假体变得从关节松开,不管什么原因,则所述假体需要替换。因为患者的骨存量有限,所以对于关节成形术来说可能的替换手术的数量也有限。
应了解,关节成形术是高度侵入性的且要求手术切除全部或者大部分一个或者一个以上涉及修复的骨的关节表面。通常在此等程序中,将髓腔空间扩张相当大以适合所述骨内假体的茎干。扩孔导致患者骨存量丢失且随着时间过去随后的骨质溶解会经常导致假体松动。另外,植入物和骨配合处的面积随时间而减少要求所述假体最终将替换。因为患者的骨存量有限,所以对于关节成形术来说可能的替换手术的数量也有限。简而言之,经15至20年的过程,而且在一些情况下甚至经更短的时期,患者可耗尽治疗选择,最终导致疼痛、无功能关节。
2001年三月27日授予Fell等人的美国专利第6,206,927号和2003年五月6日授予Fell等人的美国专利第6,558,421号公开一种不需要骨切除的可手术植入膝假体。此假体描述为基本上为椭圆形并带有一条或一条以上直边。因此,此等装置未设计为基本上符合活体内及/或基底骨剩余软骨的实际形状(轮廓)。因此,由于患者的周围软骨及/或基底软骨下骨和所述假体之间厚度和曲率之间的差异,所述植入物的整合会极为困难。2003年四月29日授予Aicher等人的美国专利6,554,866描述一单关节膝关节假体。
已描述了不连接于胫骨和股骨的交互转位膝装置。例如,Platt等人(1969)″Mould Arthroplasty of the Knee,″Journal of Bone and Joint Surgery 51B(1):76-87描述一种具有凸形下表面不严格连接于胫骨的半关节成形术。已描述了连接于骨的装置。两种附件是通用的。McKeever设计是一种横杆部件,从顶视图看形状类似“t”,其从装置的骨啮合表面延伸以使所述“t”部分刺入骨表面,同时所述“t”自其延伸的周围表面邻接骨表面。参见McKeever,″Tibial Plateau Prosthesis,″第7章,第86页。一种替代性附接设计是Macintosh设计,其用定形翼片替代一系列多平面锯齿或齿状物。参见Potter,″Arthroplasty of the Knee with Tibial Metallic Implants of theMcKeever and Macintosh Design,″Surg.Clins.OfNorth Am.49(4):903-915(1969)。
1985年三月5日授予Wall的美国专利4,502,161描述由诸如带有不锈钢板或尼龙线的增强材料的硅树脂橡胶或特富龙的材料构成的假体半月板。1978年三月25日授予Goodfellow等人的美国专利4,085,466描述由塑料材料制成的半月板组件。半月板损伤的重建也已经以碳纤维-聚氨基甲酸酯-聚(L-丙交酯)尝试。Leeslag等人,Biological and Biomechanical Performance of Biomaterials(Christel等人编)Elsevier Science Publishers B.V.,Amsterdam.1986.第347-352页。半月板损伤也可能以生物可吸收材料和组织支架重建。
但是当前可用的装置并不总是提供理想的与关节表面的对准和所得关节适合性。不良的对准和不良的关节适合性可例如导致关节的不稳定性。此外,此等解决方案中没有一个考虑到约80%经历膝外科手术的患者具有健康的侧部隔腔且仅需修复中部的髁和髌骨。另外10%仅具有侧髁损坏。因此,90%的患者不需要全髁表面修复。
因此,仍需要用于关节修复的组合物,其包括考虑到欲修复的实际损坏的利于软骨替换系统和周围软骨之间整合的方法和组合物。另外,需要通过提供更加接近类似患者的自然膝关节解剖学的表面来改善关节矫正程序的解剖学结果的植入物或植入系统。此外,需要提供改良的功能关节的植入物或者植入系统。
发明内容
本发明提供用于以一个或者一个以上植入物替换膝关节(例如软骨、半月板及/或骨)的部分(例如患病区及/或稍大于所述患病区的区域)的新颖装置和方法,其中所述植入物实现与周围结构和组织的解剖学上或近似解剖学上的适合。在其中所述装置及/或方法包括与基底关节骨结合的元件的情况下,本发明也提供可实现与软骨下骨的近似解剖学对准的骨结合元件。本发明也提供以单次切割或者以少量相对小的切割来预处理植入位点。也可提供不对称组件以通过提供精确类似于自然膝关节解剖学的解决方案来改善经修复关节的解剖学功能性。经改善的解剖学结果转而产生经修复关节的改善功能结果。本发明也提供包括一种或一种以上用以实现最佳关节矫正的植入物的套组。
附图说明
图1A是用于评估需要根据本发明的修复的关节的方法的方块图,其中在接受选定植入物之前仍存在的关节表面是未改变的或者基本上未改变的。图1B是用于评估需要根据本发明的修复的关节的方法的方块图,其中在设计适于实现所述修复的植入物之前,现有关节表面是未改变的或基本上未改变的。图1C是用于开发植入物和在患者中使用所述植入物的方法的方块图。
图2A是适于在膝关节的胫骨坪植入的本发明的关节植入物的透视图。图2B是图2A的植入物的顶视图。图2C是图2B的植入物沿展示于图2B的线C-C的截面图。图2D是沿展示于图2B的线D-D的截面图。图2E是沿展示于图2B的线E-E的截面图。图2F是图2A的植入物的侧视图。图2G是展示沿平行于矢状平面的平面植入的图2A的植入物的截面图。图2H是展示沿平行于冠状平面的平面植入的图2A的植入物的截面图。图2I是展示沿平行于轴的平面植入的图2A的植入物的截面图。图2J展示延伸更接近于骨中线(朝向胫骨坪边缘)和前部和后部的稍大植入物。图2K是展示龙骨形式的固定物的图2A关节植入物的替代实施例的侧视图。图2L是展示固定物的图2A的关节植入物的替代实施例的底视图。图2M展示横构件形式的固定物。图2N-O是展示下表面具有用于接受横杆的沟槽的植入物替代实施例。图2P说明多种横杆。图2Q-R说明植入膝关节的装置。图2S(1-9)说明进一步具有沿一边切削的切面的适于胫骨坪的另一植入物。图2T(1-8)说明其中将关节表面修改以产生用于植入物啮合的平坦或成角度表面的胫骨植入物的替代实施例。
图3A和B是分别从下表面和上表面视点所见适用于股骨髁的关节植入物的透视图。图3C是图3A的植入物的侧视图。图3D是植入物下表面的视图。图3E是植入物上表面的视图且图3F是植入物的截面。图3G是带有安装于其上的植入物的股骨的轴向视图。图3H是不带有髌骨的膝关节的前视图,其中所述植入物安装于股骨髁。图3I是带有植入股骨髁上的图3A的植入物以及适于胫骨坪的诸如展示于图2的植入物的膝关节的前视图。图3J-K说明进一步具有至少一个斜切面用于股骨髁上的关节植入物的替代实施例。
图4A说明根据现有技术适于股骨髁的植入物。图4B-I描述适于安置于股骨髁上的另一植入物。图4B是从上表面所见所述植入物的简单透视图。图4C是图4B的植入物的侧视图。图4D是所述植入物的下表面的顶视图。图4E和F是所述植入物的侧面透视图。图4G是带有安装于其上的植入物的股骨的轴向视图。图4H是不带有髌骨的膝关节的前视图,其中所述植入物安装于股骨髁。图4I是带有植入股骨髁上的图4B的植入物以及适于胫骨坪的诸如展示于图2的植入物的膝关节的前视图。
图5A-S描述另一适于安置于股骨髁上的植入物。图5A是展示斜切面的植入物的下表面的顶视图。图5B是所述植入物的上表面的简单透视图。图5C是从第一方向所见所述植入物的侧面透视图。图5D是从第二方向所见所述植入物的简单侧面透视图。图5E-F是展示支座负载的植入物的侧视图。图5G和H说明其中植入物具有侧轨的替代实施例。图5I说明其中植入物具有固定龙骨的另一实施例。图5J是带有安装于股骨髁上的植入物的股骨的轴向视图。图5K是不带有髌骨的膝关节的前视图,其中所述植入物安装于股骨髁。图5L是带有植入股骨髁上的图5A的植入物以及适于胫骨坪的诸如展示于图2的植入物的膝关节的前视图。图5M-N描述植入膝关节的装置。图50描述允许部分切除髁的装置的替代实施例。图5P-S说明具有一个或一个以上斜切面的植入物的替代实施例。
图6A-G说明如图5所示的装置以及包含表面图的截面数据点的图解代表图。
图7A-C说明适于部分股骨髁具有两片构造的装置的替代性设计。
图8A-J描述完整髌骨(图8A)和已经切削以安装植入物的髌骨(图8B)。展示适当髌骨植入物的顶视图和侧视图(图8C-D),并展示叠加于完整髌骨上的植入物的说明图以说明植入物圆顶相对于髌骨脊的位置。图8E-F说明叠加于髌骨上的植入物。图8G-J说明基于半成品(图8G)的髌骨植入物的替代性设计。
图9A-C描述具有任何安装于其中的所教示的装置的膝关节的代表性侧视图。图9A描述具有髁植入物和髌骨植入物的膝。图9B描述其中在后部方向上髁植入物覆盖较大部分的髁表面的具有髁植入物和髌骨植入物的膝的替代性视图。图9C说明其中植入物提供于髁、髌骨和胫骨坪上的膝关节。
图10A-D描述具有任何安装于其中的所教示装置的膝关节的前视图。图10A描述具有胫骨植入物的膝。图10B描述具有髁植入物的膝。图10C描述具有胫骨植入物和髁植入物的膝。图10D描述具有双隔腔髁植入物和胫骨植入物的膝。
具体实施方式
呈示以下描述以使得任何所属技术领域的技术人员均能够制造和使用本发明。对所描述的实施例的各种修改对所属技术领域的技术人员将易于显而易见,且本文所定义的一般原理可应用于其他实施例和应用而不悖离由所附权利要求书所界定的本发明的精神和范围。因此,本发明并不意欲限于所展示的实施例,而是和符合于本文所公开的原理和特征的最广泛范围一致。在实现完全理解所公开的本发明所需要的程度上,在本申请案中引用的所有授予的专利、专利公开案和专利申请案的说明书和图示以引用的方式并入本文中。
所属技术领域的技术人员应了解,本文所述的方法可以任何逻辑上可能的所述事件的顺序以及事件的所述顺序进行。另外,当提供一个值的范围时,应了解,在所述范围的上限和下限之间的每个插入值和任何在所述范围内的陈述和插入值均涵盖于本发明。同样,预期所述本发明变体的任何可选特征可独立或者与任何本文所述的一个或一个以上特征组合提出和主张。
除非另外说明,否则本发明的的实施可应用所属技术领域内的x射线成像和处理、层析x射线照相组合、包括A扫描、B扫描和C扫描的超声波、计算机断层扫描(CT扫描)、磁共振成像(MRI)、光学相干断层扫描、单光子发射断层扫描(SPECT)和正电子发射断层扫描(PET)的常规和数字方法。所述技术在文献中充分解释而无需在本文中描述。参见,例如X-Ray Structure Determination:A Practical Guide,第二版,编者Stout和Jensen,1989,John Wiley&Sons,出版者;Body CT:A PracticalApproach,编者出版者;X-ray Diagnosis:A Physician′s Approach,编者Lam,1998Springer-Verlag,出版者;和Dental Radiology:Understanding the X-Ray Image,编者Laetitia Brocklebank 1997,Oxford University Press出版者。也参见The EssentialPhysics of Medical Imaging(2nd Ed.),Jerrold T.Bushberg等人。
本发明提供用于修复关节,尤其用于修复关节软骨和用于促进多种软骨修复材料整合进患者的方法和组合物。其中,本文所述技术允许定制软骨修复材料以适合特定患者,例如在大小、软骨厚度及/或曲率方面。当关节软骨表面的形状(例如大小、厚度及/或曲率)在解剖学上精确或近似适合于未损坏软骨或适合于患者的原始软骨时,修复的成功率增加。可在植入前将修复材料成形,且所述成形可例如基于提供关于任何在缺陷周围的“正常”软骨的曲率或厚度的信息的电子成像及/或基于在缺陷下的骨的曲率。因此,本发明尤其提供用于部分关节替换的最低侵入性方法。所述方法仅需要最少骨存量丢失或者在一些情形下无需骨存量丢失。另外,与现有技术不同,本文所述的方法将通过在植入物和周围或毗邻软骨及/或软骨下骨之间实现精确的或近似的解剖学匹配而有助于恢复关节表面的完整性。
本发明的优点可包括但不限于(i)关节修复定制,因而对使用所述修复程序的患者来说增加功效和舒适度;(ii)在一些实施例中消除对测量欲手术修复的缺陷的外科医生的需要;(iii)消除对在植入程序期间成形材料的外科医生的需要;(iv)提供基于骨或组织成像或基于手术探针技术评估修复材料的曲率的方法;(v)提供仅具有最低或在一些情形下不具有骨存量丢失的修复关节的方法;(vi)提高手术后关节适合性;(vii)在一些实施例中提高手术后患者恢复率和(viii)改善诸如运动范围的手术后功能。因此,本文所述的方法允许设计和使用更精确适合缺陷(例如植入位点)或关节表面且因而提供改良的关节修复的关节修复材料。
I.接合和对准的评估
本文所述的方法和组合物可用以治疗由软骨疾病(例如骨关节炎)、骨损伤、软骨损伤、创伤及/或由于使用过度或年龄而致的退化引起的缺陷。其中,本发明允许卫生从业者评估和治疗所述缺陷。所关注区域的大小、体积和形状可仅包括具有缺陷的软骨的区域,但优选地也包括所述软骨缺陷周围的软骨的毗邻部分。
所属技术领域的技术人员应了解,大小、曲率及/或厚度测量可使用任何合适的技术获得。例如,一维、二维及/三维测量可使用合适的机械方法、激光装置、电磁或光学跟踪系统、模型、涂覆于关节表面硬化并“记忆表面轮廓”的材料及/或一种或一种以上所属技术领域内已知的成像技术来获得。测量可非侵入性及/或手术性(例如使用探针或其他手术装置)获得。所属技术领域的技术人员应了解,所述修复装置的厚度可根据患者的解剖结构及/或对软骨损伤的深度在任何给定点变化。另外,预期医师可通过获得例如x射线来获得目标关节的测量10且随后选择一个合适的关节替换植入物50。
所属技术领域技术人员应了解,医师可如箭头32所示从产生目标关节的模型表示30的步骤直接进行到选择合适的关节替换植入物50额步骤。另外,如流程24、25、26所示,在选择合适的关节替换植入物50之后,获得目标关节的测量10、产生目标关节的模型表示30和产生投影模型40的步骤可连续或并行重复。
图1B是展示医师在评估关节中进行的步骤的替代流程图。首先,医师获得目标关节的测量10。获得测量的步骤可通过取得所述关节的影像而完成。必要时此步骤可重复11以获得复数个影像以进一步改进关节评估过程。一旦医师获得必要的测量,将信息用于产生所评估的目标关节的模型表示30。此模型表示可为地形图或者影像的形式。所述关节的模型表示可为一维、二维或者三维的。必要或需要时可重复所述方法31。其可包括实际模型。在评估了所述关节的模型表示30后,医师可视情况产生矫正条件下的目标关节的投影模型表示40。必要或需要时此步骤可重复41。使用关节地形条件和关节投影影像之间的差异,医师随后可设计关节植入物52,其适于实现矫正的关节解剖结构,每当需要实现希望的植入物设计时可重复所述设计过程53。医师也可评估提供诸如轨、龙骨、唇缘、钉、十字形茎干或固定物、横杆等的其他部件是否增强植入物在目标关节中的性能。
所属技术领域的技术人员应了解,医师可如箭头38所示从产生目标关节的模型表示30的步骤直接进行到设计合适的关节替换植入物52的步骤。类似于以上所示的流程,如流程42、43、44所示,在设计合适的关节替换植入物52之后,获得目标关节的测量10、产生目标关节的模型表示30和产生投影模型40的步骤可连续或并行重复。
图1C是说明选择用于患者的植入物的方法的流程图。首先,使用上述技术或合适且在实施本发明时在所属技术领域中已知的技术,测量患病软骨或软骨丢失区域的大小。必要时此步骤可重复多次。一旦测量了所述软骨缺陷的大小,可视情况测量毗邻软骨的厚度110。必要时此过程也可重复111。在测量软骨丢失或测量毗邻软骨的厚度之后,随后测量关节表面的曲率120。或者,可测量软骨下骨。应了解,测量可进行于所修复关节的表面或配合表面以利于产生植入物表面的最佳设计。
一旦测量了表面,使用者可选择植入物库中含有的最佳适合植入物130或者产生一个患者特异性植入物132。必要或需要时可重复此等步骤以得到用于患者的最佳适合植入物131、133。所属技术领域的技术人员应了解,可测试选择或设计植入物的包含于患者的MRI或x射线中的信息以确保所述装置的表面实现与患者的关节表面良好的适合。测试可通过例如将植入物影像叠加于患者关节的影像上来完成。一旦确定选择或设计了合适的植入物,则可例如通过从所述关节表面移除软骨或骨准备植入位点140,或者可将植入物置入关节150。
所选择或设计的关节植入物实现解剖学上或近似解剖学上与关节现有表面的适合,同时呈示复制自然关节解剖结构的相对关节表面的配合表面。在此情形下,可评估现有的关节表面以及希望的所得关节表面。此项技术尤其适用于不固定到骨里的植入物。
所属技术领域的技术人员应了解,医师或其他实施本发明的人员可获得目标关节的测量10且随后设计52或选择50合适的关节替换植入物。
II.修复材料
发现多种材料可用于实施本发明,其包括但不限于塑料、金属、结晶游离金属、陶瓷、生物材料(例如胶原蛋白或其他细胞外基质材料)、羟磷灰石、细胞(例如干细胞、软骨细胞或类似物)或其组合。基于获得的关于缺陷和关节表面及/或软骨下骨的信息(例如测量),可形成或选择修复材料。另外,使用一种或一种以上本文所述的此等技术,具有适合于特定软骨缺陷的曲率的软骨替换或再生材料将符合关节表面的轮廓和形状并将匹配周围软骨的厚度。所述修复材料可包括任何材料的组合,且一般包括至少一种非柔性材料,例如不易于弯曲或改变的材料。
A.金属和聚合修复材料
当前,关节修复系统通常应用金属及/或聚合材料,其包括例如固定到基底骨(例如在膝假体的情形下为股骨)中的假体。参见例如2001年三月20日授予Afriat等人的美国专利第6,203,576号和2001年十一月27日授予Ogel等人的美国专利第6,322,588号及其中引用的参考文献。多种金属适用于实施本发明且可基于任何标准选择。例如,材料选择可基于赋予所要刚性程度的弹性。适当金属的非限制性实例包括银、金、铂、钯、铱、铜、锡、铅、锑、铋、锌、钛、钴、不锈钢、镍、铁合金、诸如Elgiloy(钴-铬-镍合金)和MP35N(镍-钴-铬-钼合金)的钴合金和Nitinol(镍-钛合金)、铝、锰、铁、钽、诸如流金合金(Liquidmetal alloy)(购自LiquidMetal Technologies,www.liquidmetal.com)的结晶游离金属、其他可缓慢形成多价金属离子例如以抑制与患者的体液或组织接触的植入基质钙化的金属及其组合。
合适的合成聚合物包括但不限于聚酰胺(例如尼龙)、聚酯、聚苯乙烯、聚丙烯酸酯、乙烯聚合物(例如聚乙烯、聚四氟乙烯、聚丙烯和聚氯乙烯)、聚碳酸酯、聚氨基甲酸酯、聚二甲基硅氧烷、乙酸纤维素、聚甲基丙烯酸甲酯、聚醚醚酮、乙烯乙酸乙烯酯、聚砜、硝酸纤维素、类似共聚物和其混合物。也可使用生物吸收合成聚合物,诸如葡聚糖、羟乙基淀粉、明胶衍生物、聚乙烯吡咯烷酮、聚乙烯醇、聚[N-(2-羟丙基)甲基丙烯酸酰胺]、聚(羟基酸)、聚(ε-己内酯)、聚乳酸、聚乙醇酸、聚(二甲基乙醇酸)、聚(羟基丁酸酯),且也可使用类似的共聚物。
其他材料也为合适的,例如称为聚醚醚酮(PEEK)的聚酮。其包括材料PEEK450G,其为可购自Victrex of Lancashire,Great Britain的经批准用于医学植入的未填充PEEK。(Victrex位于www.matweb.com或参见Boedeker www.boedeker.com)。此材料的其他来源包括位于Panoli,India的Gharda(www.ghardapolymers.com)。
应注意,所选的材料也可为填充的。例如,其他级别的PEEK也可利用和涵盖,诸如30%玻璃填充或30%碳填充,只要所述材料由FDA或者其他管理实体批准用于可植入装置。玻璃填充PEEK降低膨胀率并且相对于未填充部分增加PEEK的弯曲模数。已知所得产物因其改良的强度、刚性或者稳定性而为理想的。已知碳填充PEEK增强PEEK的压缩强度和刚性并且降低其膨胀率。碳填充PEEK提供耐磨损性和负载能力。
应了解,可使用其他抗疲劳、具有良好记忆、柔性及/或可挠曲、具有极低吸湿性和良好耐磨损及/或磨蚀性的合适的类似生物相容热塑性或热塑性缩聚物材料而不悖离本发明的范围。所述植入物也可包含聚醚酮酮(PEKK)。
可使用的其他材料包括聚醚酮(PEK)、聚醚酮醚酮酮(PEKEKK)和聚醚醚酮酮(PEEKK),且通常为聚芳基醚醚酮。进一步可使用其他聚酮以及其他热塑性材料。
可参考以下文献的可用于所述植入物的适当聚合物,其所有均以引用的方式并入本文。所述文献包括:PCT公开案WO02/02158A1,日期为2002年一月10日且标题为Bio-Compatible Polymeric Materials;PCT公开案WO02/00275A1,日期为2002年一月3日且标题为Bio-Compatible Polymeric Materials;和PCT公开案WO02/00270A1,日期为2002年一月3日且标题为Bio-Compatible PolymericMaterials。
所述聚合物可通过包括常规聚合物加工方法的多种方法的任一种来制备。优选方法包括例如适于产生具有重要结构特征的聚合物组件的注射成形和诸如反应注射成形和立体光造型的快速成形方法。可通过物理磨蚀或化学蚀变将基板纹理化或使其多孔化以有利于结合金属涂层。诸如挤出、注射、压缩成形及/或机械加工技术也为适合的。通常,因其物理和化学特性而选择所述聚合物并适于承载和分散关节表面之间的物理负载。
一种以上的金属及/或聚合物可彼此之间组合使用。例如,一种或一种以上含金属基板可在一个或一个以上区域涂以聚合物或者一种或一种以上含聚合物基板可在一个或一个以上区域涂以一种或一种以上的金属。
所述系统或假体可为多孔的或多孔涂布的。所述多孔表面组件可由包括金属、陶瓷和聚合物的各种材料制成。此等表面组件转而可通过各种方法固定于众多由各种金属形成的结构核心。合适的多孔涂层包括但不限于金属、陶瓷、聚合材料(例如生物中性弹性体,诸如硅树脂橡胶、聚乙烯对苯二甲酸酯及/或其组合)或其组合。参见例如1971年九月20日授予Hahn的美国专利第3,605,123号、1974年五月7日授予Tronzo的美国专利第3,808,606号和1974年十月29日授予Tronzo的美国专利第3,843,975号;1967年四月18日授予Smith的美国专利第3,314,420号、1976年十月26日授予Scharbach的美国专利第3,987,499号;和德国Offenlegungsschrift2,306,552。可存在一个以上涂层且所述层可具有相同或不同的孔隙率。参见例如1976年二月17日授予Kahn等人的美国专利第3,938,198号。所述涂层可通过以粉末化聚合物环绕一个核心且加热直至固化来涂覆以形成具有一个相互连接的孔的内在网络的涂层。所述孔的弯曲度(例如通过所述孔的长度与直径的测量)在评估所述涂层在假体装置上的使用的可能的成功率方面是重要的。也参见1980年七月22日授予Morris的美国专利第4,213,816号。所述孔涂层可以粉末和整体经受使粉末结合于基板的高温的物件的形式应用。选择合适的聚合物及/或粉末涂层可考虑本文所引用的教示和参考文献来确定,例如基于其熔融指数。B.生物修复材料
修复材料也可单独或与非生物材料组合包括一种或一种以上生物材料。例如,可设计或成形任何基本材料而且诸如胎儿软骨细胞的合适的软骨替换或再生材料可应用于所述基底。随后所述细胞可结合于所述基底生长直至达到围绕软骨缺陷的软骨的厚度(及/或曲率)。离体和活体内培养物中各种基板上生长细胞(例如软骨细胞)的条件描述于例如1995年十二月26日授予Slivka等人的美国专利第5,478,739号、1998年十二月1日授予Naughton等人的5,842,477、2001年十二月4日授予Vibe-Hansen等人的6,283,980和2002年四月2日授予Salzmann等人的6,365,405。合适基板的非限制性实例包括塑料、组织支架、骨替换材料(例如羟磷灰石、生物可吸收材料)或任何其他适于在其上生长软骨替换或再生材料的材料。
生物聚合物可为天然发生的或通过发酵和类似方式活体外产生。合适的生物聚合物包括但不限于胶原蛋白、弹性蛋白、丝、角蛋白、明胶、聚氨基酸、肠线缝合线、多糖(例如纤维素和淀粉)和其混合物。生物聚合物可为生物可吸收的。
用于本文所述方法的生物材料可为自体移植物(来自相同的患者)、同种异体移植物(来自相同物种的另一个体)及/或异种移植物(来自另一物种)。也参见2002年三月21日公开Alexander等人的国际专利公开案WO02/22014和1997年八月7日公开的Lee的WO97/27885。在某些实施例中,优选自体材料,因为其承担的对主体的免疫并发症的风险降低,所述免疫并发症包括所述材料的再吸收、发炎及/或使植入位点周围的组织起疤痕。
在本发明的一个实施例中,将一个探针用于从供体位点收集组织并预备接受位点。所述供体位点可位于异种移植物、同种异体移植物或自体移植物中。所述探针用于实现供体组织样本和接受位点之间的良好解剖学匹配。特别设计所述探针以实现供体组织样本和接受位点之间的无缝或近似无缝匹配。所述探针可例如为圆柱形。所述探针的末端通常为锋利的以利于组织穿透。另外,所述探针的末端通常为空心的以接受组织。所述探针可在离其末端的限定距离处具有一个边缘,在离末端1厘米的距离处,且所述边缘可用以实现用于收集的组织穿透的限定深度。所述边缘可在外部或可在所述探针的空心部分的内部。例如,整形外科手术医生可取用所述探针并以物理压力将其推进至软骨、软骨下骨和在诸如膝关节的关节的情形中在下方的骨髓。所述医生可推进所述探针直至所述外部或内部边缘到达软骨表面。在此方面,所述边缘会防止进一步的组织穿透从而实现恒定和可再现的组织穿透。所述探针的末端可包括一个或一个以上的刃、锯样结构或组织切割机构。例如,所述探针的末端可包括由若干小刃组成的虹膜样机构。所述刃可使用手动、发动机或电机构驱动从而切穿组织并将组织样本和基底组织分离。通常,其将在供体和受体中重复。在虹膜形刃机构的情形下,可驱动个别刃以关闭所述虹膜形机构从而将组织样本与供体位点分离。
在本发明的另一实施例中,可在探针末端内部整合一个激光装置或者射频装置。所述激光装置或射频装置可用以切穿组织并将组织样本与基底组织分离。
在本发明的一个实施例中,可在供体和受体中使用相同的探针。在另一实施例中,可使用物理尺度上稍微不同的类似形状的探针。例如,用于受体的探针可比用于供体的探针稍小,从而实现组织样本或组织移植物与受体位点之间的紧密适合。用于受体的探针也可比用于供体的探针稍短,从而纠正在从供体材料中的基底组织分离或切割组织样本期间丢失的任何组织。
可将任何生物修复材料消毒以失活诸如细菌、病毒、酵母、霉菌、支原体和寄生虫的生物污染物。消毒可使用任何合适的技术进行,例如辐射,诸如γ辐射。
本文所述的任何生物材料可使用自动装置收集。所述自动装置可使用来自用于组织收集的电子影像的信息。
在某些实施例中,软骨替换材料具有特定生物化学组成。例如,围绕缺陷的软骨的生物化学组成可通过取得组织样本和化学分析或者通过成像技术来评估。例如,Alexander的WO02/22014描述将钆用于关节软骨的成像以监测软骨内的粘多糖含量。软骨替换或再生材料随后可以一定的方式制成或培养以实现类似于围绕植入位点的软骨组成的生物化学组成。用于实现所要生物化学组成的培养条件可包括例如改变浓度。软骨替换或再生材料的生物化学组成可例如通过控制某些营养和生长因子的浓度和暴露时间来影响。
III.装置设计
A.软骨模型
使用软骨厚度和曲率的信息,可产生关节软骨和基底骨表面的物理模型。此物理模型可代表关节内有限面积或其可涵盖全部关节。此模型也可考虑到半月板的存在或不存在以及一些或所有软骨的存在或不存在。例如,在膝关节中,所述物理模型可仅涵盖中部或侧部股骨髁、股骨髁和切口区、中部胫骨坪、侧部胫骨坪、全部胫骨坪、中部髌骨、侧部髌骨、全部髌骨或全部关节。软骨患病区的位置可例如使用3D坐标系统或3D欧几里德距离来确定,如WO02/22014所述。
可以此方式测定欲修复缺陷的大小。此方法考虑到例如约80%的患者具有健康的侧部组件。显而易见,一些但非全部的缺陷会包括少于全部的软骨。因此,在本发明的一个实施例中,测量围绕在一个或一个以上软骨缺陷周围的正常或仅轻微患病的软骨的厚度。此厚度可在单个点获得,或者优选地在多个点获得,例如2点,4-6点,7-10点,多于10点或在全部剩余软骨的全长。另外,一旦测定了缺陷的大小,可选择合适的疗法(例如关节修复系统)从而尽可能保留健康的周围组织。
在其他实施例中,可测量关节表面的曲率以设计及/或成形修复材料。另外,可测量剩余软骨的厚度和关节表面的曲率以设计及/或成形修复材料。或者,可测量软骨下骨的曲率并将所得测量用以选择或成形软骨替换材料。例如,软骨下骨的轮廓可用以再产生虚拟软骨表面:可鉴别患病软骨区域的边缘。可测量患病区域中软骨下骨外形。随后可通过将软骨下骨表面复制到软骨表面中产生虚拟轮廓,藉此使软骨下骨表面的拷贝连接患病软骨区域的边缘。在成形装置时,可使所述轮廓成形以与现存软骨配合或计算一些或所有软骨的切除。
图2A展示适于植入于膝关节的胫骨坪的本发明的关节植入物200的简单透视顶视图。如图2A所示,所述植入物可使用例如如以上联系图1A和B所述的双表面评估来产生。
植入物200具有一个上表面202、一个下表面204和一个外周边缘206。形成上表面202从而其形成一个用于接受相对关节表面的啮合表面;在此实例中部分凹陷以接受股骨。所述凹陷表面的凹陷可变化从而其呈现对相对关节表面的表面,例如与其连接的股骨啮合表面的负表面。所属技术领域的技术人员应了解,负印模无需准确。
植入物200的上表面202可通过多种方法的任一种成形。例如,上表面202可通过使所述表面从胫骨坪上的现存软骨及/或骨表面突出来成形,或者可将其成形以反映股骨髁以便当其啮合股骨髁时优化所述植入物的呈示表面。或者,可将上表面202成形以与相对于相对股骨髁成形的植入物的下表面配合。
下表面204具有一个匹配或近似匹配关节的胫骨坪的凸起表面从而其产生与所述胫骨坪的解剖学上或近似解剖学上的适合。根据胫骨坪的形状,下表面也可部分凸起。因此,下表面204呈现在现存表面内适配胫骨坪的表面。其可形成以匹配现存表面或匹配关节表面重复后的表面。
所属技术领域的技术人员应了解,下表面204的凸起表面无需完全凸起。相反,下表面204更可能由适配胫骨坪或经表面重塑的坪的现存表面内的凸起和凹陷部分组成。因此,所述表面基本上为变化的凸起和凹陷。
图2B展示图2A的关节植入物的顶视图。如图2B所示,植入物的外部形状208可拉长。拉长形式可产生多种形状,包括椭圆形、拟椭圆形、跑道形等。但是,应了解,外部尺寸一般是不规则的,因此不形成准确的例如椭圆的几何形状。所属技术领域的技术人员应了解,植入物的实际外形可根据欲矫正的关节缺陷的性质而变化。因此,长度L与宽度W的比率可在例如0.25至2.0且更明确的说0.5至1.5之间变化。如图2B进一步展示,当在沿着植入物的宽度的点上获取时沿植入物200轴的长度变化。例如,如图2B所示,LR w L2L3。
现转向图2C-E,沿着线C-C、D-D和E-E描述展示于图2B的植入物的截面。所述植入物分别具有厚度t1、t2和t3。如由截面所说明,所述植入物的厚度沿其长度L和宽度W变化。在植入物200的特定位置的实际厚度是欲替换的软骨及/或骨的厚度与欲复制的关节配合表面的函数。另外,植入物200在沿其长度L或宽度W的任何位置处的曲线是欲替换的软骨及/或骨的函数。
图2F是图2A的植入物200的侧视图。在此实例中,植入物200在第一末端的高度hf不同于植入物在第二末端的高度h2。另外,上缘208可具有一个向下方向的总体斜面。但是,如所说明,上缘208的实际斜面沿着其长度变化且在一些情形下可为正斜面。另外,下缘210可具有一个向下方向的总体斜面。如所说明,下缘210的实际斜面沿着其长度变化且在一些情形下可为正斜面。所属技术领域的技术人员应了解,根据个别患者的解剖结构,可产生其中hf和h2相等或实质上相等的植入物而不悖离本发明的范围。
图2G是沿着体内矢状平面取的展示植入膝关节1020内从而植入物200的下表面204处于胫骨坪1022上且股骨1024处于植入物200的上表面202上的植入物200的截面。图2H是沿着体内冠状平面取的展示植入膝关节1020内的植入物200的截面。从此视图显而易见,安置植入物200从而其适合于上关节表面224。所属技术领域的技术人员应了解,需要时,所述关节表面可为中部或侧部小平面。
图2I是沿着身体的轴平面展示植入膝关节1020内的植入物200展示从空中或上部视点取得的视图的视图。图2J是其中植入物稍大从而其延伸中部更接近骨(意即朝向胫骨坪的边缘1023)以及向前和向后延伸的替代实施例的视图。
图2K是根据替代实施例本发明的植入物200的截面。在此实施例中,下表面204进一步包括一个关节固定物212。如在此实施例中所说明,关节固定物212形成一个从植入物200的下表面204延伸并伸入例如关节骨的凸起、龙骨或垂直部件。所属技术领域的技术人员应了解,所述龙骨可为垂直的或位于身体平面内。
另外,如图2L所示,关节固定物212可具有横构件214从而从底视图可见所述关节固定物212具有十字形或“x”形的外观。所属技术领域的技术人员应了解,关节固定物212可具有多种其他形式而仍在关节中实现提供增加的植入物200稳定性的相同目标。此等形式包括但不限于销、球、牙状物等。另外,必要时可提供一种或一种以上的关节固定物212。图2M和N说明从侧视图和前视图所见的双组件植入物的替代实施例的截面。
在图2M所示的替代实施例中,希望在下表面204上提供一个或一个以上横构件220以提供所述植入物相对于股骨或股骨植入物表面的少量平移运动。在此情形中,可形成整合于所述植入物表面的横构件或所述部件为一个或一个以上适配于所述植入物200的下表面204上的沟槽222的独立片断。所述沟槽可形成如图2N1所示的单个通道或可具有如图2N2所示的一个以上的通道。在各情形中,所示横构件则适配于与植入物200相关的杆中所示的通道。所属技术领域的技术人员应了解,可形成所述横杆部件220整合于植入物而不悖离本发明的范围。
如图2Q-R所示,预期胫骨坪表面通过在其上形成接受横杆部件的通道来预备。因此,有助于植入物牢固安放于关节内同时在膝关节运动时仍提供围绕轴的运动的能力。
图2S(1-9)说明植入物200的一个替代实施例。如图2S说明,斜切边缘释放出一个锐角。图2S(1)说明一个具有单个圆角或斜角230的植入物。所述圆角位于在胫骨脊后部前方的植入物上。如图2S(2)所示,提供两个圆角230、231并用于后部斜面。在图2S(3)中,提供第三个圆角234以产生两个后部斜面的切割表面。
现转向图2S(4),取消植入物的切线,留下三个后部曲线。图2S(5)展示切线扩展的结果。图2S(6)说明当选择底部曲线而无切线扩展时对设计的影响。曲线扩展和选择的结果展示于图2S(7)。如图2S(8-9)可见,所得角具有更柔和的边缘而损失少于0.5毫米的关节空间。所属技术领域的技术人员应了解,可添加其他切割平面而不悖离本发明的范围。
图2T说明其中胫骨坪250的表面改变以容纳植入物的植入物200的一个替代实施例。如图2T(1-2)说明,可改变胫骨坪仅一半的关节表面251或全部表面252。如图2T(3-4)说明,后-前表面扩孔为平坦的260或者成梯度的262。梯度相对于前表面可为正或负的。也可于图2T的植入物使用梯度,其中所述梯度位于平面或体内或者相对于身体成角度。另外,可提供连接机构将植入物固定于改变的表面。如图2T(5-7)所示,可提供龙骨264。所述龙骨264可位于例如矢状或冠状平面的平面内或者不位于一个平面内(如图2T(7)所示)。图2T(8)说明覆盖整个胫骨坪的植入物。此等植入物的上表面设计为符合在联系图1所述的步骤下测定的关节的投影形状,而下表面设计为平坦的或实质上平坦以符合关节的修正表面。
现转向图3A-I,展示一个适于提供相对于图2A的植入物的关节表面的植入物。此植入物矫正股骨1024下表面(例如与胫骨坪配合的股骨髁)上的缺陷并可单独使用(意即)于股骨1024上或与另一关节修复装置组合使用。所述装置表面的形成可使用以上联系图2的植入物描述的技术实现。
图3A展示一个具有弯曲配合表面302和凸起关节邻接表面304的植入物300的透视图。鉴于为促进植入物与骨的连接而提供的固定物306,所述关节邻接表面304无需形成与股骨解剖学或近似解剖学上的适合。在此情形下,固定物306展示为具有带缺口头的钉栓。所述缺口便于骨内的固定过程。但是,可使用不具有缺口的钉栓以及带有其他利于固定过程的构造的钉栓或者十字形茎干。所述植入物的钉栓和其他部分可为多孔涂布的。所述植入物可不使用骨粘合剂或使用骨粘合剂插入。所述植入物可设计为邻接软骨下骨,意即其可基本上符合软骨下骨的轮廓。其具有不需移除骨而是代以钉栓孔从而显著保留骨存量的优点。
所述固定物306可呈现多种形式而不悖离本发明的范围同时在关节内仍完成提供植入物300的增加的稳定性的相同目标。此等形式包括但不限于销、泡、球、牙状物等。此外,必要时可提供一种或一种以上的关节固定物306。如图3说明,使用三个销固定植入物300。但是,可使用更多或更少的关节固定物、十字形茎干或销而不悖离本发明的范围。
图3B展示进一步说明三个将植入物固定于骨的固定物306的用途的骨配合表面304的简单透视上视图。各固定物306具有一个在顶部带有一个头312的茎干310。如图3C所示,茎干310具有平行的壁从而其形成从所述骨配合表面延伸的管或圆柱。所述茎干的部分形成接近所述头312的狭窄的颈314。所属技术领域的技术人员应了解,所述壁无需为平行的,而可为倾斜的以形成圆锥状。另外,颈314和头312无需存在。如上所述,可使用其他适于固定的构造而不悖离本发明的范围。
现转向图3D,其说明植入物300的胫骨配合表面302的视图。从此图显而易见,所述表面是弯曲的从而其凸起或基本上凸起以配合坪的凹陷表面。图3E说明进一步说明三个用于将植入物300固定于骨的钉栓306的用途的植入物300的上表面304。如所说明,安置所述三个钉栓306以形成一个三角。但是,所属技术领域的技术人员应了解,可使用一个或一个以上的钉栓,且钉栓306的与另一个的定位可为如所展示的或者为任何能够形成所要固定的其他适当定位。图3F说明沿着展示于图3E的线F-F取的植入物300的截面。通常所述钉栓在植入物的表面上定位从而所述钉栓垂直于股骨髁,其可不产生垂直于植入物表面的钉栓。
图3G说明具有侧部髁1002和中部髁1004的股骨1000的轴向视图。也展示沿着侧部上髁1008和中部上髁1010的髁间窝。也展示股骨1012的髌骨表面。说明图3A中说明的植入物300覆盖一部分侧部髁。也展示钉栓306利于将植入物300固定于髁。
图3H说明从前部透视所见的膝关节1020。植入物300植入在髁上。如图3I所示,安置植入物300从而其连接于设计为矫正胫骨坪中缺陷的植入物200,诸如图2中展示者。
图3J-K说明用于在髁上替换的植入物300。在此实施例中,提供至少一个平坦表面或斜切面360以配合在预备关节中在髁表面制成的切面。平坦表面360通常不包含所述植入物300的全部毗邻表面304。
图4A说明典型全膝关节成形术(“TKA”)最初的膝499的设计。提供后部切面498、前端切面497和末端切面496以及斜切面495。
图4B和4C说明另一植入物400。如图4B所示,成形植入物400从而其沿着股骨1012的髌骨表面覆盖侧部和中部股骨髁。植入物400具有一个侧部髁组件410和一个中部髁组件420以及将所述侧部髁组件410连接到中部髁组件420同时覆盖至少一部分股骨1012的髌骨表面的桥430。必要时植入物400可视情况与一个或一个以上图2中所示的植入物相对。图4C是图4B的植入物的侧视图。如图4C所示,使植入物400的上表面402弯曲以符合股骨髁的曲率。可构造所述弯曲从而其符合现存股骨髁之一或两个的实际曲率或符合表面重塑关节后股骨髁之一或两个的曲率。可提供一个或一个以上钉栓430以帮助将植入物固定于骨。所属技术领域的技术人员应了解,可构造植入物从而构造接触第一髁的上表面以配合现存髁同时接触第二髁的表面具有一个或一个以上平坦表面以配合经改造的髁表面。
图4D说明展示于图4B的植入物400的顶视图。从此视图应了解,构造植入物400的下表面404以符合股骨髁的形状,例如在未损害的关节中健康股骨髁会呈示于胫骨表面的形状。
图4E和F说明从下表面(意即胫骨坪配合表面)所见的植入物的透视图。
图4G说明具有侧部髁1002和中部髁1004的股骨1000的轴向视图。也展示沿着侧部上髁1008的髁间窝1006。说明于图4B的植入物400说明覆盖股骨1012的髁和髌骨表面。也展示钉栓430利于将植入物400固定于髁。
图4H说明从前部透视所见的膝关节1050。植入物400植入在两个髁上。如图4I所示,安置植入物400从而其连接于设计为矫正胫骨坪中缺陷的植入物200,诸如图2中展示者。
所属技术领域的技术人员应了解,植入物400可由具有记忆从而可构造植入物以扣合髁的材料制造。或者,可将其成形从而其符合所述表面而无需扣合。
图5A和5B说明另一适于修复损坏髁的植入物500。如图5A所示,构造植入物500从而其仅覆盖侧部或中部股骨髁510之一。所述植入物不同于图3的植入物,因为所述植入物500也覆盖至少一部分股骨512的髌骨表面。
类似于图4的植入物,所述植入物可视情况相对于一个或一个以上诸如图2所示的植入物或相对关节表面,且可与诸如图3的植入物的植入物组合。图5C是图5A的植入物的透视侧视图。如图5C所示,使植入物500的上表面502弯曲以符合其配合的股骨髁的曲率和部分其覆盖的股骨的髌骨表面。可提供一个或一个以上钉栓530以帮助将植入物固定于骨。另外,可在符合植入物配合的关节表面的表面上制成的视情况提供的切面的髁组件的下表面502上提供一个成角度表面503。
图5D说明展示于图5A的植入物500的透视顶视图。从此视图应了解,构造植入物504的下表面500以符合股骨髁的形状,例如在未损害的关节中健康股骨髁会呈示于胫骨表面的形状。
图5E是展示从顶部513延伸至线(平面17)和从线(平面18)延伸至底部515的划阴影的三点承载支撑区的植入物500的视图。同时说明从上表面延伸的钉栓530。图5F说明具有从上表面延伸的钉栓530的植入物500的上表面。图5F也说明划阴影的悬臂承载支撑区,其从线(平面18)延伸至植入物的顶部。承载力和各支撑条件的方向是基于生理承载冲撞。表1展示取自Seth Greenwald的研究的生理承载。
表1生理承载
″1″ ″2″ ″3″
弯曲角度(度) 60° 90°
法向力N 2,900 3,263 3,625
(磅) (652) (733.5) (815)
法向力案例 行走(4.0×BW) 下楼梯(4.5×BW) 上楼梯(5.0×BW)
体重(BW)取为60岁老年男性,身高173cm,平均体重74kg(163磅)。1″Tibial Plateau Surface Stress in TKA:A Factor Influencing Polymer FailureSeriesIII-Posterior Stabilized Designs;″Paul D.Postak,B.Sc.,Christine S.Heim,B.Sc.,A.Seth Greenwald,D.Phil.;整形外科研究实验室,The Mt.Sinai MedicalCenter,Cleveland,Ohio。呈示于第62届年度AAOS会议,1995。
使用在本申请案中描述的植入物500,三点承载可见于组1(2900N)。为复制承载方案的最坏情形,使用75/25负荷分布(2900N的75%=2175N)。所述负荷将集中于直接位于支承表面上结构体的下方并与其垂直的6mm直径圆形区。
转向图5F中所示的悬臂负荷,所述负荷以75/25负荷分布出现于组3或90。如以上实例,所述负荷将集中于位于垂直于后部髁的平坦切割表面的中部髁最后部中心的6mm直径圆形区。
图5G和H说明具有沿着植入物500的中部及/或侧部提供一个或一个以上轨道521的轨道设计的植入物500的替代实施例。安置所述轨道521从而其在连接倾斜表面503之前沿着中部517及/或侧部519侧面的一部分延伸。应了解,可提供单侧轨521而不悖离本发明的范围。
图5I说明具有龙骨设计的植入物500的另一实施例。龙骨523(或形成于中部的轨)提供于植入物的上表面。在此实施例中,龙骨523位于植入物的表面上而非在侧面。应了解,龙骨可如所示的居中、基本上居中或偏心定位。可提供倾斜表面503以连接经改造的关节表面。或者,当所述关节表面损坏或改造时,可构造切面503以配合所述损坏或改造的表面。
图5J说明具有侧部髁1002和中部髁1004的股骨1000的轴向视图。也展示沿着侧部上髁1008和中部上髁1010的髁间窝。也说明股骨1012的髌骨表面。展示说明于图5A的植入物500覆盖股骨1012的侧部髁和部分髌骨表面。也展示钉栓530利于将植入物500固定于髁和髌骨表面。
图5K说明从前部透视所见的膝关节1020。植入物500植入在侧部髁上。图5L说明具有覆盖中部髁1004的植入物500的膝关节1020。如图5K和L说明,符合髌骨表面的植入物500的形状可呈现多种曲率而不悖离本发明的范围。
现转向图5M和N,安置植入物500从而其连接于设计为矫正胫骨坪中缺陷的植入物200,诸如图2中展示者。
在本发明的另一实施例中,植入物500可具有基本上符合髁的表面但具有一个对应于骨上倾斜切面的平坦部分的上表面502,如图5O所示。
现转向图5P-Q,展示从侧视点所见的植入物500,其在前和后切面之间具有7个差异。
图5R-S说明具有配合于关节表面的轮廓表面560和一个前切面561以及一个后切面562的植入物500。图5S展示从稍微不同的角度所见的相同植入物500。图5T说明具有配合于关节表面的轮廓表面560和后切面562、末端切面563以及一个斜切面564的另一植入物500。在此实施例中未提供前切面。图5U说明从侧面透视所见的图5T的植入物500。所述切面通常小于TKA所要求的切面,意即通常小于10mm。必要时,此植入物的切面的设计允许在以后的时间对膝进行修正手术。
图6A-G说明具有植入物表面形状自其产生的截面610、620的图形表示的图5的植入物。图6A说明位于提取的表面形状600顶部的植入物500的顶视图。植入物500的此视图说明与植入物512的桥部分相关的槽514,其覆盖股骨的髌骨表面(或者滑车区域)以提供接近软骨表面的配合表面。所属技术领域的技术人员应了解,由于解剖结构上的不同,为中部髁设计的植入物的形状不必是为侧部髁设计的植入物的镜像。因此,例如,槽514不会存在于为股骨的中部髁和髌骨表面设计的植入物中。因而,可设计所述植入物以包括所有或部分滑车区域或者完全将其排除。
图6B说明位于另一起源的表面形状601上的植入物500的底视图。图6C是展示延伸通过展示于图6A的提取表面形状600的植入物500的底视图。图6D是展示覆盖所述提取表面600的植入物的髁翼的图6C的特写视图。图6E说明位于表面形状600的图形表示上的植入物500的顶部前视图。图6F是前视图且图6G是底部后视图。
图7A-C说明用于矫正关节类似于以上植入物500的植入物700。但是,植入物700由两个组件组成。第一组件710啮合股骨的髁,根据设计啮合中部或侧部髁。第二组件720啮合股骨的髌骨表面。如先前实施例所讨论,可构造植入物700的表面从而基于补偿外翻或内翻畸形的设计及/或整平股骨表面的股骨天然形状的投影来成形末端表面722(例如面对胫骨坪的表面)。或者可基于胫骨坪的形状来成形末端表面以提供经设计以最佳配合胫骨坪的表面。可构造最近表面724(例如啮合股骨髁的表面)从而其反映在其损坏条件或其改造条件下的股骨表面。同样,最近表面可具有一个或一个以上形成例如斜切面的整平部分726。另外,所述表面可包括促进附接于股骨的机构728,诸如龙骨、牙、十字形茎干及类似物。髁植入物的中部饰面部分具有一个锥形表面730,而髌骨组件的侧部饰面部分也具有一个锥形表面从而各组件对其他组件呈示锥形表面730。
通过如图7所示将中部和侧部隔腔的表面分开为独立的接合表面,植入物提供改良的共形表面与软骨下骨的适合。另外,保护股骨的侧前部免受可引起骨丢失的应力。同样,植入物的各组件的更小尺寸使得植入物能够使用更小的切口置入关节。最终,髌骨组件的损坏得到改善。
图8A-F说明具有植入物810的髌骨800。必要时植入物810可具有一个或一个以上的钉栓、十字形茎干或其他固定机构。所属技术领域的技术人员应了解,其他设计可以使用本揭示案的技术达成而不悖离本发明的范围。图8A说明完整髌骨800的透视图。图8B说明其中髌骨800的一个表面已经切削以形成一个光滑表面802配合植入物的髌骨800。图8C说明具有安置于所述光滑表面802上的植入物810的髌骨800。植入物810具有一个邻接所述髌骨的光滑表面802的盘式结构812和一个位于盘812上的圆顶814,从而所述圆顶原位安置以致其匹配髌骨脊的定位。如所说明,可配置植入物810从而所述盘的边缘偏移髌骨的实际边缘1毫米。所属技术领域的技术人员应了解,盘812和圆顶814可形成为单个单元或可由多个组件形成。图8D是安置于髌骨800上的植入物810的侧视图。如所展示,所述圆顶安置于植入物上从而其偏离中心。所述圆顶的最佳定位将由髌骨脊的位置确定。
现转向图8E-F,展示植入物810叠加于未改变的髌骨800上以说明植入物圆顶814的定位符合髌骨脊的位置。
图8G-J说明髌骨植入物的替代性设计。图8G说明在其开始阶段作为半成品的植入物850,其带有一个具有从其延伸用于固定髌骨的钉栓854的平坦下表面852。关节或上表面860具有一个全圆形圆顶856和一个可机械加工以匹配骨切面的圆形平坦部分858。关节表面860具有“帽”或”somberero”形的外观,具有一个带有边缘的圆顶。圆顶856的中心也为承载表面的中心。切削边缘858以符合特定患者的需要。图8J说明一个已经由图8G-I展示的半成品形成的植入物。图8I展示复数个可能的切削线。
图10A-D提供具有一个或一个以上植入其中的上述植入物的膝关节的冠状平面的替代性视图。图10A说明具有一个置于其中的胫骨植入物200的膝。图10A说明具有一个置于其中的髁植入物300的膝。如上所述,可在一个关节内提供复数个本文教示的植入物以恢复关节运动性。图10C说明其中具有两个植入物的膝关节。首先,在胫骨坪上提供胫骨植入物200且在相对的髁上提供第二植入物300。所属技术领域的技术人员应了解。可安装所述植入物从而所述植入物彼此呈示配合表面(如所说明)或并不呈示。例如,当将胫骨植入物200置于膝的中部隔腔中时,且将所述髁植入物置于侧部隔腔。所属技术领域的技术人员应了解其他组合。现转向图10D,沿双隔腔髁植入物500提供胫骨植入物200。如上所述,此等植入物可连接于膝关节的相同隔腔,但无需如此。
可设计所述关节成形系统以反映胫骨形状、股骨形状及/或髌骨形状的方面。胫骨形状和股骨形状可包括软骨、骨或其两者。另外,植入物的形状也可包括部分或所有诸如半月板的其他关节结构的组件。所述半月板为可压缩的,尤其在走路或负载期间。因此,可设计植入物以结合由于负载或身体活动期间压缩半月板而出现的半月板形状的特征。例如,可设计植入物200的下表面204以匹配包括软骨或骨或两者的胫骨坪的形状。植入物200的上表面2020可为胫骨的关节表面(尤其在未由半月板覆盖的区域中)和半月板的组合。因此,所述装置的外部形状可为半月板高度的反映。由于压缩,其可为例如20%、40%、60%或80%的未压缩半月板高度。
可类似设计植入物300的上表面304以匹配包括软骨或骨或两者的股骨髁的形状。植入物300的下表面302可为胫骨坪的表面(尤其在未由半月板覆盖的区域中)和半月板的组合。因此,所述装置的外部形状可为半月板高度的反映。由于压缩,其可为例如20%、40%、60%或80%的未压缩半月板高度。同样此等相同特性可应用于展示于图4-8的植入物。
在一些实施例中,反映半月板形状的装置的外形可由另一优选可压缩材料制成。如果选择可压缩材料,则其优选地设计为基本上匹配所述半月板的可压缩性和生物力学特征。所述整个装置通常可由此材料或非金属材料制成。
用于任何欲修复的关节表面的半月板的高度和形状可直接在影像测试时测量。如果部分或全部半月板损坏,则半月板高度和形状可来自关节的测量或使用可提供对半月板尺寸的估计的其他关节结构的测量。
在另一实施例中,植入物300、400或500的上面可根据股骨成形。所述形状优选地可源自股骨相对于胫骨坪的运动模式因而计算股骨髁在胫骨和半月板上弯曲、伸展、旋转、平移和滑行时股骨形状和胫骨股骨接触的变化。
所述运动模式可使用诸如荧光透视法、MRI、步态分析和其组合的任何所属技术领域中已知的现有或将有的测试来测量。
所述关节成形术可具有两个或两个以上组件,一个基本上配合于胫骨表面而另一个基本上接合于股骨组件。所述两个组件可具有一个平坦的相对表面。或者,所述相对表面可为弯曲的。曲率可反映包括在关节运动期间的胫骨形状、股骨形状和半月板形状及其组合。
但组件系统的实例包括但不限于塑料、聚合物、金属、金属合金、结晶游离金属、生物材料或其组合。在某些实施例中,面向基底骨的修复系统的表面可为光滑的。在其他实施例中,面向基底骨的修复系统的表面可为多孔或多孔涂布的。另一方面,面向基底骨的修复系统的表面设计为具有一个或一个以上凹槽,例如利于周围组织的内生长。所述装置的外表面可具有梯级样设计,其可利于改变生物力学应力。也可视情况在所述装置上的一个或一个以上的位置添加凸缘(例如以防止修复系统旋转、控制套牢及/或防止沉降入髓腔)。所述凸缘可为圆锥或圆柱形设计的部分。面向基底骨的部分或全部修复系统也可为平坦的,其可有助于控制植入物的深度并防止套牢。
多组件系统的非限制性实例包括金属、塑料、金属合金、结晶游离金属和一种或一种以上生物材料的组合。关节表面修复系统的一个或一个以上的组件可由生物材料(例如带有诸如软骨细胞或干细胞自身或者接种于诸如生物吸收材料或组织支架内的细胞的组织支架、同种异体移植物、自体移植物或其组合)及/或非生物材料(例如聚乙烯或诸如铬钴合金的铬合金)组成。
因此,所述修复系统可包括一个或一个以上单一材料或材料组合的区域,例如,所述关节修复系统可具有第一和第二组件。通常设计所述第一组件以具有类似于丢失的软骨组织的大小、厚度和曲率,而第二组件通常设计为具有类似于软骨下骨的曲率。此外,第一组件可具有类似于关节软骨的生物力学特性,包括但不限于类似的弹性和对轴向负载和剪切力的抗性。所述第一和第二组件可由两种不同的金属或金属合金组成。所述系统的一个或一个以上的组件(例如第二部分)可由包括但不限于骨的生物材料或者包括但不限于羟磷灰石、钽、铬合金、铬钴合金或其他技术合金的非生物材料组成。
关节表面修复系统的一个或一个以上的区域(例如第一部分及/或第二部分的外部边缘)可为生物吸收性的,例如以允许关节表面修复系统和患者的正常软骨之间的界面随着时间充以透明或纤维软骨。类似地,一个或一个以上的区域(例如关节表面修复系统的第一部分及/或第二部分的外部边缘)可为多孔性的。多孔度可在整个多孔区域线性或非线性改变,其中多孔度通常会朝向所述关节表面修复系统的中心降低。所述孔可设计用于软骨细胞、软骨基质和结缔组织的向内生长,因而实现关节表面修复系统和周围软骨之间的光滑界面。
所述修复系统(例如多组件系统中的第二组件)可使用诸如甲基丙烯酸甲酯、可注射羟磷灰石或钙磷灰石材料及类似物连接于患者的骨。
在某些实施例中,所述关节表面修复系统的一个或一个以上的部分在植入时可为柔性的或为液体或可变形且随后可硬化。硬化可发生于例如1秒至2小时内(或其间任何时期),优选地在1秒至少30分钟内(或其间任何时期),更优选地在1秒与10分钟之间(或其间任何时期)。
关节表面修复系统的一个或一个以上的组件可适于接受注射。例如,所述关节表面修复系统的外表面可在其中具有一个或一个以上开口。可将开口制作为一定尺寸以接受螺钉、管道、针或其他可插入并前进所要深度的装置,例如,通过所述关节表面修复系统进入髓隙。诸如甲基丙烯酸甲酯和可注射羟磷灰石或钙磷灰石材料的注射剂随后可通过所述开口(或者经其插入的管道)引入髓隙从而使所述关节表面修复系统结合所述髓隙。类似地,可将螺钉或销或其他固定机构插入开口并推进至基底软骨下骨和骨髓或骨骺以实现将所述关节表面修复系统固定于骨。所述螺钉或销的部分或所有组件可为生物吸收性的,例如,突进到髓隙的螺钉的末端部分可为生物吸收性的。在手术后初始时期,所述螺钉可提供关节表面修复系统的最初固定。随后,骨沿着关节软骨修复系统的下表面向内生长到多孔涂布区可代替所述关节表面修复系统对骨的最初稳定器。
所述关节表面修复系统可使用销或螺钉或其他附接机构固定到患者的骨上。所述附接机构可为生物吸收性的。所述螺钉或销或附接机构可从骨的非软骨覆盖部分或从关节的非承重表面朝向关节表面修复系统插入或推进。
在所述关节表面修复系统和周围正常软骨之间的界面可成角度,例如以相对于基底软骨下骨的90度的角度定向。合适的角度可考虑本文的教示来确定,且在某些情形下,非90度的角度可有利于负载沿着所述关节表面修复系统和周围正常软骨之间的界面分布。
所述关节表面修复系统和周围正常软骨及/或骨之间的界面可覆盖以医药剂或生物活性剂,例如刺激所述修复系统生物整合进正常软骨及/或软骨的材料。所述界面的表面区可为不规则的,例如以增加界面暴露于医药剂或生物活性剂。
E.预先存在的修复系统
如本文所述,可获得各种大小、曲率和厚度的修复系统。所述修复系统可按目录分类并储存以产生随后可自其选择个别患者的适当系统的系统库。换句话说,在一个特定对象中评估缺陷或关节表面并从所述库中选择具有合适形状和大小的预先存在的修复系统用于进一步操作(例如成形)和植入。
F.小型假体
入上所述,本文所述的方法和组合物可用于仅替换部分关节表面,例如关节表面上患病软骨或丢失软骨的区域。在此等系统中,关节表面修复系统可设计为仅替换患病或丢失软骨的区域或者其可延伸越过所述患病或丢失软骨的区域例如3或5毫米进入正常的邻近软骨。在某些实施例中,所述假体替换少于约70%至80%(或其间任何值)的关节表面(例如任何给定关节表面,诸如单个股骨髁等),优选的少于约50%至70%(或其间任何值),更优选地少于约30%至50%(或其间任何值),更优选地少于约20%至30%(或其间任何值),甚至更优选地少于约20%的关节表面。
所述假体可包括多个组件,例如一个植入骨的组件(例如一个金属装置)连接于一个成形以覆盖重叠于所述骨上的软骨的缺陷的组件。也可包括例如中间盘、半月板修复系统及类似物的其他组件。预期各组件替换少于所有相应关节表面。但是,各组件无需替换所述关节表面的相同部分。换句话说,所述假体可具有替换少于30%的骨的骨植入组件和替换60%的软骨的软骨组件。所述假体可包括任何组合,倘若各组件替换少于全部关节表面。
可形成或选择所述关节表面修复系统从而其将达到近似解剖学上适合或匹配于周围或毗邻软骨或骨。通常,形成及/或选择所述关节表面修复系统从而位于外表面的其外部边缘将对准于周围或毗邻软骨。
因此,可设计所述关节修复系统以替换例如股骨髁中的关节表面的承重部分(或多于或少于所述承重部分)。所述承重表面是指在正常日常生活活动期间(例如正常步法)两个相对关节表面之间的接触区域。至少一个或一个以上承重部分可在例如股骨髁上和胫骨上以此方式替换。
在其他实施例中,可在承重区中鉴别患病软骨或软骨丢失的区域且可以关节表面修复系统替换仅部分承重区,尤其含有患病软骨或软骨丢失区的部分。
在另一实施例中,可设计或选择关节修复系统以基本上替换所有关节表面,例如髁。
在另一实施例中,例如在具有弥散性软骨丢失的患者中,可设计关节修复系统以替换比承重表面稍大的区域。
在某些方面,欲修复的缺陷仅位于一个关节表面上,通常是患病最严重的表面上。例如,在中部股骨髁中具有严重软骨丢失但在胫骨中疾病严重性稍轻的患者中,所述髁表面修复系统可仅应用于中部股骨髁。优选的,在本文所述的方法中,设计关节表面修复系统以实现精确的或者近似的与毗邻正常软骨的解剖学上的适合。
在其他实施例中,可修复多于一个关节表面。修复区通常限于患病软骨或软骨丢失区或承重表面内比患病软骨或软骨丢失区稍大的区域。
在另一实施例中,所述关节表面修复的一个或一个以上的组件(例如指向基底骨或骨髓的系统的表面)可为多孔或多孔涂布的。已经提议多种不同的多孔金属涂层用于通过骨组织向内生长增强金属假体的固定。因此,例如1974年十二月24日授予Pilliar的美国专利第3,855,638号公开可用作骨假体的包含由固体金属材料基板和黏附于并在至少部分所述基板表面上延伸的相同固体金属材料的多孔涂层组成的复合结构的外科手术修复装置。所述多孔涂层由在其彼此接触以在所述涂层中界定复数个连接的孔隙孔的点处结合到一起的复数个小的金属材料离散颗粒组成。可在复数个单层中分布的所述颗粒的大小和间隔可为以下情形:即平均孔隙孔大小不大于约200微米。另外,孔大小分布可在基板涂层界面至涂层表面基本上均一。在另一实施例中,关节表面修复系统可含有一种或一种以上聚合材料,其可载有和释放包括药物或其他可用于药物递送的医药处理的治疗剂。所述聚合材料可例如置于多孔涂层内。所述聚合材料可用以释放例如骨或软骨生长刺激药物的治疗药物。此实施例可与其他实施例组合,其中部分软骨表面修复系统可为生物吸收性的。例如,软骨表面修复系统的第一层或其第一层的部分可为生物吸收性的。当第一层逐渐吸收时,本地释放软骨生长刺激药物可利于软骨细胞的向内生长和基质形成。
在任何上述方法和组合物中,所述关节表面修复系统可预先制造为具有一定范围的尺寸、曲率和厚度。或者,所述关节表面修复系统可为个体患者定制。
IV.制造
A.修整
在某些情形下,将会在形成(例如生长至所要厚度)之前或之后要求修整所述修复系统,例如当所要求的软骨材料的厚度不均匀时(例如当软骨替换或再生材料的不同部分要求不同的厚度时)。
所述替换材料可通过任何合适的技术来修整,其包括但不限于浇铸技术、机械磨蚀、激光磨蚀或烧蚀、射频处理、冷冻消融、营养物暴露时间和浓度的变化、酶或生长因子和任何其他适于影响或改变软骨厚度的方法。参见例如,2000年三月23日公开的Mansmann的WO00/15153;如果使用酶消化,则将所述软骨替换或再生材料的某些部分暴露于高剂量的酶或可暴露较长时间作为在所述材料的不同部分中实现软骨替换或再生材料的不同厚度和曲率的方法。
所述材料可手工及/或自动修整,例如使用将预先选择的厚度及/或曲率输入其中且随后使用所输入的信息设计装置的程序以实现所要形状的装置。
除了修整所述软骨修复材料之外或代之,植入位点(例如骨表面、任何剩余软骨材料等)也可通过任何适当技术修整以增强所述修复材料的整合。
B.定尺寸
可形成或选择所述关节表面修复系统从而其将达到近似解剖学上适合或匹配于周围或毗邻软骨、软骨下骨、半月板及/或其他组织。所述修复系统的形状可基于电子影像的分析(例如MRI、CT、数字层析x射线照相组合、光学相干断层扫描或类似方法)。如果希望关节修复系统替换患病软骨或丢失软骨的区域,则可使用在电子影像中提供健康软骨形状的虚拟重建的方法实现近似解剖学上的适合。
在本发明的一个实施例中,在软骨缺陷位置处的近似正常软骨表面可通过在整个软骨缺陷或患病软骨区域插入健康软骨表面来重建。其可例如通过借助于参数表面(例如B样条表面)描述健康软骨来实现,控制点按其安放从而参数表面符合健康软骨的轮廓并桥接软骨缺陷或患病软骨区域。所述参数表面的连续性特性将利用周围健康软骨的轮廓提供桥接软骨缺陷或患病软骨区域的部分的平滑整合。所述参数表面在软骨缺陷区域或患病软骨区域上的部分可用以确定关节修复系统的形状或部分形状以匹配周围软骨。
在另一实施例中,在软骨缺陷或患病软骨区域的位置处的近似正常软骨表面可使用形态学影像处理来重建。在第一步中,可使用手工、半自动及/或自动分割技术(例如手工追踪、区域生长、活线(live wire)、以模型为基础的分割)从电子影像中提取软骨,产生一个双重影像。软骨中的缺陷表现为可利用以2-D活3-D进行的形态闭合操作充以适当选择的结构元件的缺口。所述闭合操作通常定义为膨胀接着侵蚀。膨胀操作者将输出影像中的当前象素设定为1,如果至少一个结构元件的象素位于源影像中的区域内。侵蚀操作者将输出影像中的当前象素设定为1,如果全部结构元件位于源影像中的区域内。软骨缺陷或患病软骨的区域的填充在可用以确定关节修复系统的形状或部分形状的软骨缺陷区域或患病软骨区域上产生一个新的表面以匹配周围软骨或软骨下骨。
如上所述,可从各种大小、曲率和厚度的系统的库或数据库形成或选择所述关节修复系统从而其将实现与周围或毗邻软骨及/或软骨下骨的近似解剖学上的适合或匹配。所述系统可预先制成或制成以为个别患者定制。为在手术前控制关节修复系统与周围或毗邻软骨或软骨下骨或半月板及其他组织的适合或匹配,可使用在其植入处将关节修复系统投影在解剖位置上的软件程序。合适的软件可购得及/或易于由熟练的编程者修改或设计。
在另一实施例中,关节表面修复系统可使用一个或一个以上3-D影像投影在植入位点上。从诸如MRI或CT的3-D电子影像中使用手工、半自动及/或自动分割技术提取软骨及/或软骨下骨和其他解剖结构。例如使用多边形或NURBS表面或其他参数表面表示法产生软骨及/或软骨下骨和其他解剖结构以及所述关节修复系统的3-D代表图。各种参数表面表示法的描述参见例如Foley,J.D.等人,ComputerGraphics:Principles and Practice in C;Addison-Wesley,第二版,1995。
软骨及/或软骨下骨和其他解剖结构以及关节修复系统的3-D表示可并入通用坐标系统。随后所述关节修复系统可置于所要植入位点。软骨、软骨下骨、半月板和其他解剖结构以及关节修复系统的表示再现为3-D影像,例如应用程序设计界面(API)OpenGLE(由SGI,Inc.开发的高级3-D图形函数标准库;可作为PC显卡驱动的部分获得,例如从NVIVIA显卡的www.nvidia.com或3Dlabs产品的www.3dlabs.com,或者作为Unix工作站的系统软件获得)或Directe(基于PC系统的微软视窗(Microsoft Windows)的多媒体API;获自www.microsoft.com)。可呈现例如通过旋转将其交互式或非交互式移动实时或非实时从变化的角度展示软骨、软骨下骨、半月板或其他解剖结构以及关节修复系统的3-D影像。
可设计所述软件从而自动选择包括手术工具和器具具有对软骨及/或软骨下骨最佳适合的关节修复系统,例如使用一些上述技术。或者,操作者可选择包括手术工具和器具的软骨修复系统并使用合适工具和技术将其投入或拖入植入位点。操作者可在三个维度上相对于植入位点移动和旋转关节修复系统并可进行所述关节修复系统和所述植入位点之间的适合的视觉检查。所述视觉检查可由计算机协助。所述程序可重复直至实现满意的适合。所述程序可由操作者手动进行或其可全部或部分由计算机协助。例如,所述软件可选择操作者可测试的第一试验植入物。操作者可评估适合度。所述软件可设计并用以突出植入物与周围软骨或软骨下骨或半月板或其他组织之间的对准不良区域。基于此信息,所述软件和操作者可随后选择另一植入物并测试其对准。所属技术领域的技术人员将易于选择、修改及/或产生合适的用于本文所述的目的的计算机程序。
在另一实施例中,所述植入位点可使用一个或一个以上截面2-D影像直观化。通常将使用一系列2-D截面影像。所述2-D影像可利用诸如CT、MRI、数字层析x射线照相组合、超声波或光学相干断层扫描的影像测试使用所属技术领域的技术人员已知的方法和工具来产生。所述关节修复系统随后可叠加于一个或一个以上此等2-D影像上。所述2-D截面影像可在从矢状到冠状等的其他平面中重建。也可使用各向同性数据组(例如其中共平面分辨时片层厚度相同或近似相同的数据组)或近似各向同性数据组。可同时显示多个平面,例如使用分开的屏幕显示器。操作者也可在任何所要方向上实时或近似实时滚动2-D影像;操作者可旋转成像的组织体积同时进行此项操作。所述关节修复系统可利用不同显示平面(例如矢状、冠状或轴向,通常匹配显示软骨、软骨下骨、半月板或其他组织的2-D影像的平面)以截面显示。或者,可使用一个三维显示器用于所述关节修复系统。所述关节修复系统的2-D电子影像和2-D或3-D表示可合并到通用坐标系统中。随后所述关节修复系统可置于所要植入位点。所述系列的解剖结构、植入位点和关节修复系统的2-D截面可实时或非实时交互式显示(例如操作者可滚动一系列片层)或非交互式显示(例如作为移动所述系列的片层的动画)。
C.快速成型
快速成型是一种用于从一个物体的计算机模型制造一个三维物体的技术。一种特殊的打印机用于从复数个二维层制造原型。计算机软件将物体的代表图分割为复数个不同的二维层并随后三维打印机为各个由所述软件分割的层制造一个材料层。将各种所制造的层合并在一起形成所要原型。更多关于快速成型技术的信息可获自2002年六月27日公开的Russell等人的美国专利公开案第2002/0079601A1号。使用快速成型的一个优点是其使得安全使用毒性或强效化合物的自由形式制造技术的使用成为可能。此等化合物可安全并入一个赋形剂封套,其减少工作人员暴露。
提供一个粉末塞和构造床。粉末包括任何可制成为粉末或与液体结合的材料(金属、塑料等)。所述粉末从一个供料源用一个撒布器滚压到一个床的表面上。层的厚度由计算机控制。随后打印头将粘合剂流体沉积到其中希望所述粉末结合的位置处的粉末层上。再次将粉末滚压进构造床中并重复所述过程,同时在各层控制所述结合流体沉积以符合装置形成的三维定位。对于此过程的进一步讨论,参见例如2003年九月18日公开的Monkhouse等人的美国专利公开案第2003/017365A1号。
所述快速成型可使用如以上部分I所述的获得的二维影像以确定成型机的各层的各二维形状。在此情形下,各二维影像片层会符合二维原型片。或者,可如上所述确定缺陷的三维形状,且随后分解为用于快速成型方法的二维片层。使用三维模型的优点为用于快速成型机的二维片层可在获取所述二维影像时沿着相同平面或完全沿着不同的平面。
快速成型可与铸造技术组合或结合使用。例如,具有符合关节修复系统的内部维度的壳或容器壳使用快速成型技术制成。塑料或蜡样材料通常用于此目的。随后可例如以陶瓷涂布所述容器的内部用于随后的铸造。使用此方法,可产生个性化铸件。
快速成型可用于产生关节修复系统。快速成型可在制造工厂内进行。或者,其可在进行了外科手术测量后在手术室中进行。
V.手术技术
在对患者进行手术之前,外科医生可在手术前使用例如直立式Ap x射线进行膝的对准测定。在进行手术前评估时,可鉴别任何存在的侧部和髌骨刺。
使用标准手术技术,将患者麻醉并做一个切口以提供部分欲修复的膝关节的入口。最初可使用一个中部入口以能够进行关节的关节镜检查。其后,所述中部入口可与手术切口结合及/或可使用标准侧部入口。
一旦形成一个适当的切口,检查暴露的隔腔的完整性,包括韧带结构的完整性。必要时,可移除部分半月板以及在AP x射线中鉴别的或可存在于关节内的任何骨刺或骨赘。为利于移除骨赘,外科医生可弯曲膝以暴露其他中部和中后部骨赘。另外,骨赘可在此过程中从髌骨移除。必要时,也可在此点移除中部及/或侧部半月板,若需要,半月板的边缘一起随同移除。
所属技术领域的技术人员应了解,可需要评估中部十字形韧带以利于移除胫骨骨赘。
一旦关节表面已经准备好,则可将所要植入物插入所述关节。
A.胫骨坪
为将图2的装置200插入中部隔腔,在髌骨腱中部进行小型切口关节切开术。一旦形成所述切口,暴露中部髁并使用一把合适的刀和弯曲的骨凿向关节线下约1厘米准备一根中部套管。在准备中部套管之后,在中部胫骨坪附近安置一个Z牵引器并沿着胫骨和股骨移除半月板的前部和骨赘。在此时,膝应弯曲至约60或更大。移除所述Z牵引器并将植入物安置依靠于股骨的最末端位置以及胫骨坪边缘上方。将所述植入物径直向后推。在一些情形下,应用外翻应力可使植入物的插入变得容易。
为将图2的装置插入侧部隔腔,在髌骨腱侧部进行小型切口关节切开术。一旦形成所述切口,暴露侧部髁并使用一把合适的刀和弯曲的骨凿向关节线下约1厘米准备一根侧部套管。在准备所述侧部套管之后,在侧部胫骨坪附近安置一个Z牵引器并沿着胫骨和股骨移除半月板的前部和骨赘。移除所述Z牵引器并将植入物安置依靠于股骨的末端位置以及胫骨坪边缘上方。以45角度保持所述植入物并使用向着侧脊的侧部向中部的推力靠着侧部髁旋转所述植入物。在一些情形下,应用内翻应力可使植入物的插入变得容易。
一旦植入图2所示的任何植入物,所述装置应置于胫骨坪的AP边界的0至2毫米内并叠加于所述边界上。随后应进行活动范围的校验以确认所示植入物的平移最小。确认安置后,使用业内已知的技术进行创口闭合。
所属技术领域的技术人员应了解,希望可根据所述植入物200的构造进行胫骨坪表面的其他处理。例如,一个或一个以上通道或凹槽可形成于胫骨坪的表面上以容纳固定机构,诸如展示于图2K的龙骨212或展示于图2M-N的横构件222、221。
B.髁修复系统
为插入图3所示的装置300,根据欲修复的髁,形成一个前中部或前侧部皮肤切口,其开始于离髌骨前缘约1厘米。所述切口范围通常可为沿着髌骨边缘例如6-10厘米。所属技术领域的技术人员应了解,在一些情形下可要求更长的切口。
可需要切割超过滑膜深度以促进进入关节。另外,也可除去所有或部分脂肪垫并使得能够检查相对的关节隔腔。
通常,从股骨和胫骨的全部中部及/或侧部边缘移除骨赘以及可能相当多的髌骨边缘上的骨赘。
尽管其为可能的,但通常在植入物装置300前所述装置不要求切除末端股骨。但是必要时,可进行骨切割以提供用于所述植入物的表面。
在此接合点,使患者的腿处于90弯曲位置。随后可在髁上安置覆盖末端股骨软骨的I导轨。所述导轨使得外科医生能够确定使得植入物300能够精确置于髁上的孔的方位。当所述导轨正确放置后,钻孔进入髁以产生深度1-3毫米的孔。一旦所述孔产生,则移除所述导轨并将植入物300安装于所述髁的表面上。可使用粘合剂以利于所述植入物300粘合于髁。
当欲修复多于一个髁时,例如使用两个图3的植入物300或图4的植入物400,或者当随后通常将髁髌骨620对准于植入物600的几何中心时。为将植入物600固定于髌骨620,可在所述髌骨表面中产生一个或一个以上洞或孔612以接受植入物600的钉栓610。
VI.套组
可将一个或一个以上上述植入物一起组合于一个套组中从而外科医生可在手术期间选择一个或一个以上植入物使用。
为说明和描述的目的提供本发明实施例的先前描述。并不希望详尽或限制本发明为所公开的精确形式。多种修改和改变对于所属技术领域中的技术人员是显而易见的。选择并描述所述实施例以最佳解释本发明的原理和其实施应用,因而使得所属技术领域中的其他技术人员能够理解本发明和各种实施例以及适于所涵盖的特定用途的各种修改。希望本发明的范围由以下权利要求书及其等效物界定。

Claims (39)

1.一种用于植入到股骨髁上的植入物,所述植入物包含:
相对骨的植入物表面和相对关节的植入物表面,其中当所述植入物植入到所述股骨髁上时,所述相对骨的植入物表面经构造以相对于至少一部分股骨的股骨髁和滑车,并且所述相对关节的植入物表面经构造以提供关节表面,并且进一步其中当所述植入物植入到所述股骨髁上时,一部分所述相对关节的植入物表面具有弯曲符合一个或多个所述股骨髁的曲率并与一个或多个所述股骨髁配合的三维形状,并且其中另一部分所述相对骨的植入物表面包含平坦表面以紧靠所述股骨髁的骨切面。
2.根据权利要求1所述的植入物,其中所述植入物具有患者中软骨缺陷的厚度。
3.根据权利要求1所述的植入物,其中所述植入物具有患者中软骨缺陷的85%的厚度。
4.根据权利要求1所述的植入物,其中所述植入物具有患者中软骨缺陷的65%-100%之间的厚度。
5.根据权利要求1所述的植入物,其中所述植入物具有软骨缺陷加上预先确定的补偿值的厚度。
6.根据权利要求5的植入物,其中选择所述补偿值以校正轴未对准。
7.根据权利要求1所述的植入物,其中所述植入物由包含金属或者金属合金的材料构造。
8.根据权利要求7所述的植入物,其中所述材料包含至少一种生物活性材料。
9.根据权利要求5所述的植入物,其中将所述植入物涂以生物活性材料。
10.根据权利要求1所述的植入物,其进一步具有用于附接于所述相对骨的植入物表面和所述相对关节的植入物表面中的至少一者的结构。
11.根据权利要求1所述的植入物,其中所述相对骨的植入物表面和相对关节的植入物表面的各个具有相对于通过至少一部分所述植入物的纵轴的斜面,且进一步其中所述相对骨的植入物表面的斜面不同于所述相对关节的植入物表面的斜面。
12.根据权利要求1所述的植入物,其中所述植入物的所述相对关节的植入物表面近似髁的、滑车的、胫骨的或髌骨的关节表面之一的形状。
13.根据权利要求1所述的植入物,其中所述植入物的髁配合表面具有至少一个用于配合具有切面的准备好的髁表面的平面。
14.根据权利要求13所述的植入物,其中准备股骨髁表面用于接受所述植入物。
15.根据权利要求14所述的植入物,其中通过形成至少一个配合所述植入物的至少一个平坦表面的平坦表面来准备所述髁表面。
16.根据权利要求1所述的植入物,其中通过移除骨来准备股骨髁表面。
17.根据权利要求16所述的植入物,其中通过移除软骨来准备所述髁表面。
18.根据权利要求16所述的植入物,其中通过形成至少一个配合所述植入物的至少一个平坦表面来准备所述髁表面。
19.根据权利要求1所述的植入物,其中所述植入物是选自植入物库。
20.根据权利要求1所述的植入物,其中所述植入物经由10厘米或更小的切口手术植入。
21.根据权利要求1所述的植入物,其中所述植入物经由6厘米或更小的切口手术植入。
22.根据权利要求1所述的植入物,其中将所述关节的运动范围被恢复。
23.根据权利要求1所述的植入物,其中形成所述植入物以相对于所述股骨上的第二髁的至少一部分。
24.根据权利要求1所述的植入物,其中所述植入物进一步包含从中部或侧部侧面之一的上表面延伸的轨。
25.根据权利要求1所述的植入物,其中所述植入物进一步包含从所述相对骨的植入物表面延伸的龙骨,其中所述龙骨处于从所述植入物的中部和侧部侧面凹进的位置。
26.根据权利要求1所述的植入物,其中一部分所述相对骨的植入物表面位于一个平面内。
27.根据权利要求26所述的植入物,其中位于一个平面内的所述部分的相对骨的植入物表面配合于所述股骨表面上的平坦切面。
28.根据权利要求1所述的植入物,其中所述植入物模仿健康关节的解剖结构。
29.根据权利要求1所述的植入物,其中所述植入物模仿手术前关节的解剖结构。
30.根据权利要求1所述的植入物,其中所述植入物模仿关节的目标解剖结构。
31.根据权利要求1所述的植入物,其中所述植入物在手术期间置于关节间隙内而不进行韧带平衡。
32.根据权利要求1所述的植入物,其中所述植入物是由髁植入物和髌骨配合植入物组成的系统。
33.根据权利要求1所述的植入物,其中所述植入物在一个位置处的厚度适于解决外翻畸形、内翻畸形和整平中的至少一种。
34.根据权利要求1所述的植入物,其进一步具有有斜面的边缘。
35.根据权利要求1所述的植入物,其中所述相对骨的植入物表面进一步具有斜切面,以配合所述股骨髁的骨切面。
36.根据权利要求1所述的植入物,其进一步具有用于植入物的后部斜面的圆角。
37.根据权利要求36所述的植入物,其中所述圆角在胫骨脊的后部的外部。
38.一种用于修复膝的套件,所述套件包含:
具有相对骨的股骨植入物表面和相对关节的股骨植入物表面的股骨髁植入物,其中当所述植入物植入到胫骨表面和髌骨的所述股骨髁部分时,所述相对骨的股骨植入物表面经构造以相对于至少一部分所述股骨髁和滑车,且所述相对关节的植入物表面经构造以提供关节表面,且进一步其中当所述植入物植入到所述股骨髁上时,一部分所述相对骨的植入物表面具有弯曲符合一个或多个所述股骨髁的曲率并与一个或多个所述股骨髁配合的三维形状;和
具有当所述植入物被植入时啮合髌骨的股骨配合表面的第一表面和可滑地啮合股骨的滑车的第二表面的髌骨植入物。
39.一种用于植入到股骨髁上的植入物,所述植入物包含:
相对骨的植入物表面;和
相对关节的植入物表面,其中当所述植入物植入到股骨髁上时,所述相对骨的植入物表面经构造以相对于至少一部分滑车和至少一个股骨髁,且其中当所述植入物植入到股骨髁上时,所述相对关节的植入物表面经构造以相对于至少一部分承重胫骨表面和髌骨,且进一步其中当所述植入物植入到所述股骨髁上时,一部分所述相对骨的植入物表面具有弯曲符合一个或多个所述股骨髁的曲率并与一个或多个所述股骨髁配合的三维形状。
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ATE504261T1 (de) 2011-04-15
CA2546958A1 (en) 2005-06-09
US20100174376A1 (en) 2010-07-08
WO2005051239A1 (en) 2005-06-09
US20140142710A1 (en) 2014-05-22
US7618451B2 (en) 2009-11-17
HK1087324A1 (en) 2006-10-13
US20040236424A1 (en) 2004-11-25
CN1913844A (zh) 2007-02-14
US20070250169A1 (en) 2007-10-25

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