CN103037809B - 植入物部件和方法 - Google Patents
植入物部件和方法 Download PDFInfo
- Publication number
- CN103037809B CN103037809B CN201180039345.2A CN201180039345A CN103037809B CN 103037809 B CN103037809 B CN 103037809B CN 201180039345 A CN201180039345 A CN 201180039345A CN 103037809 B CN103037809 B CN 103037809B
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- Prior art keywords
- implant
- porous
- protuberance
- mould
- granule
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Classifications
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- 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
- 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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- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
- A61B17/8066—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones for pelvic reconstruction
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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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- G06F9/44—Arrangements for executing specific programs
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- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
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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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- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
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Abstract
提供用于骨科植入物的系统、装置和方法。该植入物可包括基部构件(例如髋臼壳或者加强件),其构造成与加强件、凸缘杯、安装构件、或者任何其它合适的骨科附件相联接。可植入部件中的任何部件可以包括一个或多个多孔表面。该多孔表面可具有突出部,该突出部连接到该表面并从该表面延伸。可以针对特定应用改变突出部的尺寸和集中度,以适应不同的植入物和患者解剖结构。多孔植入物还可包括一个或多个内部或外部实心部分,其对植入物进行加强。
Description
相关申请的交叉引用
本申请要求2010年6月8日提交的美国临时专利申请第61/352,705号、2010年6月8日提交的美国临时申请第61/352,722号、2010年12月14日提交的美国临时申请第61/422,903号、2011年3月23日提交的美国临时申请第61/466,817号的权益,这些申请的全部内容以参考的方式并入本文中。
背景技术
由于多种原因,关节经常遭受退行性病变。当关节退变变为晚期或者不可逆时,则可能必须用假体关节置换天然关节。人工植入物(包括髋关节、肩关节和膝关节)广泛地用于骨科手术。特别地,髋关节假体是常见的。人的髋关节机械性地起球窝接头的作用,其中,股骨的球形头位于骨盆的窝形髋臼内。各种退行性疾病和损伤可能需要用合成材料(通常是金属、陶瓷或塑料)置换髋关节的全部或一部分。
更具体地,天然髋关节经常遭受退行性病变,需要用假体关节置换髋关节。通常,用股骨头与髋臼之间的两个支承面来置换髋关节。第一支承面通常为假体壳或髋臼杯,该假体壳或髋臼杯可以由金属、陶瓷材料形成,或者根据需要来选择材料。然后,将衬里(通常由聚乙烯材料(例如超高分子量聚乙烯)、陶瓷材料形成,或者在一些情况下甚至是金属衬里)紧密地配合到壳内以提供内支承面,该内支承面接收人工股骨头并且以关节连接关系与人工股骨头配合以便追随并适应股骨与髋臼之间的相对运动。
通常,通过将螺钉穿过髋臼杯中的孔或者通过用水泥固定髋臼杯而固定髋臼杯(或者髋臼杯与衬里组件)。在一些情况下,由于较差的骨储备(bone
stock)而仅用水泥将衬里粘结在患者体内。在其它情况下,可将具有多孔表面的髋臼杯压合到经扩孔的髋臼表面中。
有可能必须实施第二次或后继手术,以便用(通常更大的)置换关节来替换假体关节。经常由于骨的进一步退变或者退行性疾病的进展而导致必须实施这种手术,需要去除更多的骨并且用更大或加强的假体关节(经常称为翻修假体)置换被去除的患病的骨。例如,在髋臼的边缘附近经常发生骨丢失,这会减小用于牢固地放置压合杯的边缘覆盖范围。因此,可以将这种手术称为翻修手术。
在髋臼翻修手术中,髋臼假体一般包括附加的安装元件,例如加强件、凸缘、钩、板或者任何其它附件或安装点或构件,一旦定位这些安装元件则为置换假体提供附加的支撑和/或稳定性。由于患病区(在此情况下是髋关节)中的骨退变、骨丢失或者骨缺损,通常需要这些附加的安装或附接构件。
可连同假体系统提供各种类型的这些安装构件(该术语意图包括但不限于凸缘、叶片、板和/或钩),以便帮助外科医生实现最佳固定;安装构件的非限制性示例包括髂骨凸缘(提供骨盆的髂骨区中的固定和固着以及抵靠髂骨区的固定和固着)、坐骨叶片(提供坐骨中的固定和固着以及抵靠坐骨的固定和固着)和闭孔沟(通过与闭孔接合而提供固定和下固着)。尽管曾经试图给这种安装附件提供模块性,但到目前为止的解决方案一般来说并未提供真正的模块化。相反,它们通常提供安装构件可定位的少数离散位置,并未给外科医生提供更全范围的决定选项。
另外,在一些初次手术中,更经常地在翻修手术中,髋臼中可存在骨缺损或空隙,外科医生必须在插入新壳之前用骨移植物进行填充。这会是耗时的且费用高,并且可使患者遭遇额外的健康风险。一些技术使用与髋臼壳有关的加强件,该加强件可以联接到或者以其他方式附接到壳的外表面。
就当前的加强件而言,外科医生可以将加强件附接到骨然后植入髋臼杯。然而,许多髋臼壳依赖于骨螺钉来实现适当的固定,并且加强件经常妨碍螺钉。简而言之,外科医生需要自由地将螺钉放在最佳位置,但这损害了他们使用加强件的能力。就当前系统而言,它也占用更多的手术时间来试验部件取向然后设法发现良好的髋臼杯的骨固定。外科医生将通常必须自主决定除去的骨量而同时估计所需加强件的尺寸。在骨经常为不足的情况下,外科医生踌躇于除去任何比必须量更多的骨。
本文也描述了针对各种类型关节植入物的使用和应用的各种其它特征和改进的特征,诸如改进的骨螺钉、改进的涂层以及各种加强件去除和插入选项。
发明内容
本文中公开了用于提供模块化骨科植入物的系统、装置和方法。所述植入物可包括基部构件(例如髋臼壳或者加强件),该基部构件构造成与加强件、凸缘杯、安装构件、任何其它合适的骨科附件、或者它们的任意组合联接。安装构件例如包括凸缘、叶片、钩和板。在一些实施例中,骨科附件能够可调节地定位在基部构件或其它附件的周围,由此提供用于组装和植入所述装置的模块性。在植入物的部件之间可使用各种固定和/或锁定机构。在某些实施例中,骨科附件可移除地联接到基部构件或其它部件。在某些实施例中,骨科附件一体地设置在基部构件或其它部件上,但仍然能够可调节地定位在它们的周围。在一些实施例中,提供可膨胀的加强件、基部构件或者其它骨填充装置。在一些实施例中,提供表面特征物,该表面特征物产生摩擦并且允许在植入物与患者骨界面处的周围骨头向内生长。
本文中所述的系统、装置和方法提供植入物,该植入物产生摩擦并且允许在植入物与患者骨的界面上的周围的骨向内生长。在某些实施例中,一种可植入骨科装置包括植入物,该植入物具有接触患者关节的表面并且具有连接到该表面且升到该表面之上的多个突出部。该植入物还可包括在骨界面处分散遍及该表面的多个孔。位于植入物表面的突出部可以是钝的,或者可以是任何其它合适的形状和构造。突出部可从表面延伸至任何合适的高度,例如在大约50μm和大约2000μm之间的高度、在大约100 μm和1100 μm之间的高度、或者在大约200 μm和400 μm之间的高度。突出部可以以任何合适的集中度或密度间隔在植入物的表面上。期望的突出部密度也可以是患者特定的,并且可以基于部件所植入的天然骨的密度来决定。植入物可在其表面上具有大量的突出部特征物,并且这些单独特征物中的一个或多个在不影响该表面总体效率的情况下可落在期望的尺寸或间距之外。
在某些实施例中,植入物包括内部或外部的加强特征物。多孔植入物可包括内部或外部的加强肋,以为周围的多孔结构提供支撑。多孔植入物也可与凸缘联接,该凸缘具有用于将凸缘附接到植入物的第一端以及用于将凸缘附接到周围骨结构的第二端。多孔植入物也可包括网状表面涂层。
在某些实施例中,通过提供具有多孔带珠表面的负印痕的模具以及提供将要被涂布的植入物衬底而形成可植入骨科装置。可将颗粒插入植入物衬底与模具之间,并且可向模具、植入物衬底和颗粒施加压力或升高的温度。所提供的植入物衬底可以是实心的或者可以是多孔的,并且被插入植入物衬底与模具之间的颗粒可以是对称的或者不对称的。
在某些实施例中,通过创建模拟多孔带珠植入物的外表面形貌的三维模型并且创建植入物衬底体积的三维模型而形成可植入骨科装置。将模拟多孔带珠植入物的外表面形貌的模型应用于植入物衬底体积的模型而形成预形成体积,并且应用算法以便用期望网状结构填充预形成体积从而创建多孔植入物模型。利用该多孔植入物模型形成植入物。
在某些实施例中,通过提供具有内表面(该内表面模拟多孔带珠表面的外表面形貌几何形状的负像)的植入物的模具以及提供被放置到模具中的多个颗粒而形成可植入骨科装置。向模具和颗粒施加压力或升高的温度。被放置到模具中的颗粒可以是对称的或者不对称的。
在某些实施例中,通过提供具有内表面(该内表面模拟多孔带珠表面的外表面形貌几何形状的负像)的植入物的模具并且将一种或多种起泡剂装到该模具中而形成可植入骨科装置。以植入物的大致形状或尺寸形成多孔泡沫部件,该植入物具有模拟多孔带珠表面的外表面形貌几何形状的外表面几何形状。将多孔泡沫部件从模具移除,并且将粘合剂施加到多孔泡沫部件。将多个对称或不对称的颗粒施加到具有粘合剂的多孔泡沫部件,使多孔泡沫部件、粘合剂和颗粒经受升高的温度以将颗粒烧结到一起并烧尽泡沫部件,以形成植入物,所述植入物具有粗糙化的多孔纹理,其具有模拟经过临床验证的多孔带珠结构的外表面形貌几何形状。多孔泡沫部件可以是聚合的,并且可以是聚氨酯部件。
附图说明
当结合附图阅读下面的详细说明时,前述以及其它的目的和优点将变得显见,遍及附图中,相同的附图标记表示相同的部件,并且在附图中:
图1示出了示例性植入物部件的第一视图;
图2示出了示例性植入物部件的第二视图;
图3示出了具有球形珠表面形貌的示例性植入物涂层体积;
图4示出了具有多孔结构的示例性单元细胞(unit
cell);
图5示出了具有球形珠形貌和多孔结构的示例性涂层体积的截面;
图6示出了多孔表面的第一示例性SEM图像;并且
图7示出了多孔表面的第二示例性SEM图像。
具体实施方式
为了全面地了解本文所描述的系统、装置和方法,将对某些示例性实施例进行描述。尽管本文所述的实施例和特征具体地被描述用于髋臼系统,但应当理解的是下面所概述的所有部件、连接机构、可调节系统、固定方法、制造方法、涂层以及其它特征可以以任何合适方式相互组合,并且可适合并应用于其它手术中所使用的医疗器械和植入物,其它手术包括但不限于脊柱成形术、颅颌面手术、膝关节成形术、肩关节成形术以及足、踝、手和其它四肢手术。
在本文所描述的各种植入物和其它装置的各种实施例可结合任何合适的加强材料而使用,加强材料的非限制性示例包括骨水泥、合适的聚合物、可重吸收聚氨酯、和/或由PolyNovo Biomaterials有限公司提供的任何材料、或者它们的任何适当组合。以下的参考文件中描述了可以使用的可能材料的其它非限制性示例:标题为“Biodegradable
Polyurethane and Polyurethane Ureas”的美国专利申请公开第2006/0051394号、标题为“Biocompatible Polymer Compositions for Dual or Multi
Staged Curing”的美国专利申请公开第2005/0197422号、标题为“Biodegradable Polyurethane/Urea Compositions”的美国专利申请公开第2005/0238683号、标题为“Polymer
Compositions for Dual or Multi Staged Curing”的美国专利申请公开第2007/0225387号、标题为“Biocompatible Polymer Compositions”的美国专利申请公开第2009/0324675号、标题为“Chain
Extenders”的美国专利申请公开第2009/0175921号、以及标题为“High Modulus Polyurethane and Polyurethane/Urea
Compositions”的美国专利申请公开第2009/0099600号。前述参考文件的全部内容以参考的方式并入本文中。
现在参照图1-7,某些实施例提供具有多孔带珠(beaded)涂层的部件以及它们的制造方法。因为植入物和天然骨通常具有不同程度的柔性,从而会产生不均匀的应力分布。因此,当加载植入物时,在骨(更柔顺)与植入物(更刚性)之间的界面处通常存在一些相对运动。因此,许多植入物采用中间材料(例如骨水泥)来减小相对运动的量;然而,无水泥植入物可依赖于相对粗糙度来实现相同的目的。
历史上,已经利用小球形珠、细丝束和热喷涂金属来产生减小相对运动量所必须的摩擦。任选地,螺钉和/或压配合特征物可改善植入物到骨的固定。这种技术被骨科外科医生群体所广泛接受。然而,这些涂层的几何性质限制了它们的孔隙的位置和尺寸。更新的技术(例如采用不对称的珠或金属泡沫的技术)具有改进的孔隙位置和尺寸,但这些技术难以制造成具有有利的表面纹理。补救措施包括将阴影线放置到已形成多孔涂层的表面中(例如,通过机械加工)。其它多孔表面已经被制造成具有微观水平的尖锐突出部。这些突出部即使当骨与植入物之间存在少量相对运动时也可能引起问题。更尖锐的突出部可戳入骨中并形成骨颗粒或者可以从植入物中脱离而在植入物-骨的界面处形成磨粒。除了使植入物与骨之间的附接松动外,这些松动的颗粒可引起有害的并发症。
通过提供具有许多宏观水平的钝突出部且具有微观水平的多孔结构的带纹理表面的植入物,而解决以前的多孔表面的缺点。钝的突出部产生减小植入部件与周围骨之间相对运动量的摩擦。多孔性允许周围的骨生长到植入物中,并且植入物与骨之间相对运动的缺乏促进此向内生长。
设计和形成具有钝突出部的多孔植入物时的考虑因素是突出部的尺寸和密度。突出部形成骨最初接触植入物的区域。如果突出部太大或者间隔太远,那么突出部之间的植入物表面积的大部分将距离骨太远而不便于骨生长到植入物中,并且骨不能与植入物形成实心界面。相反,如果突出部过小或彼此过于靠近,那么它们的影响将极小并且植入物可能遇到与具有更平滑表面或者由许多集中尖锐突出部所构成表面的现有技术植入物相同的问题。理想的表面所包含的突出部大到足以产生骨与植入物之间的所需摩擦并且仍然小到足以依然允许高程度的向多孔表面内的骨生长。突出部可以具有任何适合的高度,优选在大约50 μm与大约2000 μm之间。就某些应用而言,优选的是将突出部高度限制在200 μm至400 μm之间以获得期望水平的摩擦和周围骨的向内生长。
在可植入部件的表面上的突出部可以具有适合于部件的一般应用或特定应用的任何合适的形状或形貌。在某些实施例中,每个表面突出部可以是凸块形状,就像在植入物表面上的一部分球体。突出部也可成形为诸如丝或者任何其它合适的特征物,包括在无水泥植入物中常见的特征物。
图1和图2示出了改进的髋臼植入物1500的一些实施例,该髋臼植入物1500可以是整个加强件、加强件的一部分、凸缘、板、其它安装构件、壳或者笼。改进的髋臼植入物1500模拟临床成功的多孔珠的凹凸不平的外表面几何形状和形貌,并且具有期望向内生长界面的粗糙度和孔隙度。植入物1500的表面具有钝的突出部1502,突出部1502被基本成形为植入物1500表面上的半球形的凸块。将突出部1502的尺寸和形状设计成产生期望的摩擦,该摩擦减小植入物1500相对于周围骨的运动同时允许周围骨显著地生长到多孔突出部1502以及突出部之间的多孔表面区1504中。除了上述突出部高度以外,突出部1502的间距和密度也会影响摩擦及所产生的骨向内生长的量。植入物可使用任何适当密度的突出部1502,并且该突出部优选地占据表面的大约10%至大约60%之间。突出部可被集中到大约0.25个珠/mm2和大约6个珠/mm2之间的密度。
改进的髋臼植入物(例如图1和图2的植入物1500)可以通过任何合适的方法形成,并且可以利用以下四种方法中的一种形成。
第一种方法包括以下步骤:(1)提供具有多孔带珠表面的负印痕的模具,(2)提供将要被涂布的植入物衬底,其可以是实心的或多孔的,(3)将小的不对称颗粒插入植入物衬底与所述模具之间,以及(4)向模具、植入物衬底和小的不对称颗粒施加压力和/或升高的温度以形成“未处理状态”的植入物(即,准备好完全烧结)或最终植入物(已烧结),该植入物具有粗糙化的多孔涂层,其具有模拟经过临床验证的多孔带珠结构的外表面几何形状和形貌,并且具有期望小梁结构的粗糙度和孔隙度。
第二种方法包括以下步骤:(1)创建模拟多孔带珠植入物的外表面形貌的三维模型,(2)创建植入物衬底体积的模型,(3)将模拟多孔带珠植入物外表面形貌的三维模型应用于植入物衬底体积的三维模型以形成凹凸不平的预形成体积,(4)应用算法以用期望的相互连接多孔或网状结构填充凹凸不平的预形成体积,以创建多孔植入物模型,以及(5)在快速制造工艺中使用该植入物模型形成植入物,该植入物具有粗糙化多孔纹理且具有模拟经过临床验证的多孔带珠结构的外表面形貌几何形状。
第三种方法包括以下步骤:(1)提供具有内表面(该内表面模拟多孔带珠表面的外表面形貌几何形状的负像)的植入物的模具,(2)提供多个小的不对称颗粒,(3)将多个小的不对称颗粒放置到模具中,以及(4)向模具和/或小的不对称颗粒施加压力和/或升高的温度以形成“未处理状态”的植入物(即,准备好完全烧结)或者最终植入物(已烧结),该植入物具有粗糙化的多孔纹理,其具有模拟经过临床验证的多孔带珠结构的外表面形貌几何形状。
第四种方法包括在制造金属泡沫的前期步骤中在泡沫部件上形成带珠表面,该方法包括以下步骤:(1)提供具有内表面(该内表面模拟多孔带珠表面的外表面形貌几何形状的负像)的植入物的模具,(2)将一种或多种起泡剂装到模具中,(3)以所述植入物的大致形状和/或尺寸形成多孔泡沫部件(例如,聚合的,聚氨酯),其具有模拟多孔带珠表面的外表面形貌几何形状的外表面几何形状,(4)从模具移除多孔泡沫部件,(5)将粘结剂或粘合剂施加到多孔泡沫部件,(6)将多个小的对称或不对称颗粒(或者其组合)施加到其上具有粘结剂或粘合剂的多孔泡沫部件,(7)使其上具有粘结剂或粘合剂及颗粒的多孔泡沫部件经受升高的温度以将颗粒烧结到一起和/或烧尽泡沫部件以形成“未处理状态”的植入物(即,准备好完全烧结)或者最终植入物(已烧结),该植入物具有粗糙化的多孔纹理,其具有模拟经过临床验证的多孔带珠结构的外表面形貌几何形状。该植入物具有模拟经过临床验证的多孔带珠结构的凹凸不平的外表面形貌和几何形状。
至少形成植入物的外部的衬底可以是类似于小梁结构的块状多孔网状结构。植入物的一个或多个芯部或者外表面部分可以是实心的(例如,植入物的一部分可构造成与另一个植入物部件联接)。植入物还可包括一个或多个实心的内部。例如,图1中所示的植入物1500可包括在植入物内部上的实心结构部分。该结构部分可以是在植入物1500内部上的单个实心区域或多个实心区域,其提供一系列结构肋,用以增加对植入物的支撑。该实心内部结构可具有任何合适的形状和构造,例如类似于混凝土中的钢筋的结构性格栅。示例性但非限制性的示例区域(其中需要有内部结构)包括在螺钉孔周围的区域、加强件的赤道区域、或者任何其它适当的区域。在一些实施例中,可以将聚合物泡沫溶化或燃烧从而具有珠的形状,或者可以使泡沫在珠形下层表面上发生聚合从而形成具有珠形表面的最终产品。除了实心内部部件外,植入物1500可与外部凸缘或其它安装构件相联接,以便为植入物提供额外的支撑。例如,可沿附接到植入物的凸缘在该凸缘的第一端植入植入物1500并且将植入物1500在第二端附接到患者骨(例如利用固定到凸缘中的通孔中的骨螺钉)。植入物1500也可包括类似于常见支柱和撑杆结构的外部实心加强件,以提供对植入物多孔部分的支撑。
就快速制造技术而言,可以虚拟地形成珠表面几何形状和形貌并且将其从块状多孔实体扣除,或者可以形成虚拟珠并将其与多孔实体组合。一般的意图是,在一些但不必是所有实施例中,最终产品是同质的。植入物的替代实施例可包括模拟金属丝束或者热喷涂涂层的峰和谷的表面形貌。一旦利用建模软件创建了期望几何形状的虚拟模型,则可以利用任何合适的快速制造技术来形成具有期望表面形貌的植入物部件。例如,可以使用三维印刷技术形成多孔植入物,三维印刷技术使用粉末金属来“印刷”经建模的植入物。以这种方法,可形成具有包括突出部(例如图1和图2中的突出部1502)的表面形貌的泡沫,然后用粉末金属填充该异形泡沫从而形成具有异形表面的多孔微观结构。不包含突出部的泡沫也可用于用粉末金属形成多孔微观结构,然后可以将带有突出部的期望表面形貌冲压到多孔金属植入物的表面中。
以此方式制造的植入物的优点是这些植入物包含一体式多孔性并且具有经过临床验证的多孔珠的最初骨接合表面形貌。换句话说,提供骨与植入物之间所需摩擦力的相同特征物是提供用于骨向内生长和周围生长的表面以便获得刚性且耐久固定表面的相同特征物。作为非限制性示例,表A和表B示出了可能合适的珠密度(间距)和直径的一些例子。
表A. 与从Smith &
Nephew公司获得的Birmingham Hip® Resurfacing系统一起使用的壳上的选定区域中的珠数量以及50个珠的珠直径的平均差和标准差的表,在至少3个视野中(SEM,Jeol,日本)。
表B. 用于骨向内生长的典型带珠产品的实心百分率(percent
solid)
其中,“实心百分率”是通过典型的金相学技术基于ASTM F1854所公开的测试方法(标题为“Standard Test Method for Stereological Evaluation of
Porous Coatings on Medical Implants”)所产生的珠密度的二维测量值,该文献的全部内容以参考的方式并入本文中。
图3示出了涂层体积1510,球形珠体积1512放置在其内,使得球形珠体积1512从涂层体积1510突出而形成模拟球形珠形貌的第二涂层体积。替代地,可将实心球形珠合组合到多孔涂层中。为了形成涂层体积1510,可以创建两个软件模型然后将其合并从而形成具有异形突出部表面的多孔体积的最终模型。该体积(包括多个珠体积1512)的宏观结构的第一模型可以在建模软件中创建,并且可以看上去与图3中所示的体积大致相同。
可以创建第二软件模型来产生宏观体积(例如图3中所示的体积)所希望的多孔微观结构。图4示出了示例性多孔网状结构的单元细胞1520,该单元细胞可构造成填充模拟球形珠形貌的涂层体积。单元细胞1520由支柱1512的复杂结构所构成。支柱1512的布置形成单元细胞1520内的空隙1514,从而形成期望的多孔微观结构。可改变支柱1512的尺寸和布置来控制空隙1514的数量和尺寸。通过控制支柱1512的尺寸和布置,获得了期望量和形貌的多孔结构。
图5示出了可对应于图3的涂层体积1510的涂层体积1530的截面,其模拟该体积被用网状结构替代(例如,在CAS软件中经由重复的单元细胞,例如图4中的单元细胞1520,或者利用上述4种方法中的任一种方法)之后的球形珠形貌。完成的涂层体积1530呈现异形宏观结构和多孔微观结构二者。图5中的虚线勾画了涂层体积1530的表面形貌,并且示出了形成凹凸不平表面的突出部(其在被植入时产生与骨的摩擦)。由实心结构1532与空隙1534的组合构成的涂层体积1530的微观结构形成多孔植入物,周围的骨可以生长到该多孔植入物中以填充空隙1534并形成植入物与骨的实心匹配。
图6示出了由所公开的方法制造的部件的表面的放大25倍的SEM图像1540。在此图中表面形貌不明显。图7是由所公开的方法制造的结构的放大50倍的SEM图像1550。图6和图7中所示的结构呈现上面关于涂层体积1510和1530所讨论的多孔微观结构,并且可以通过将实心宏观结构与多孔微观结构模型(例如图4中的单元细胞1520)合并来形成。
作为另一个非限制性示例,下表示出了已证明可用于各种实施例的一些其它示例性参数。在下面的表中,MVIL是指平均空隙拦截长度(其是表征平均孔径尺寸的另一种方式),尤其在孔形状和孔径尺寸不均匀的结构中。MVIL的一个通常已知定义是“测量格网线取向成平行于衬底界面。线拦截空隙的次数被与体积空隙百分率一起使用来计算平均空隙拦截长度”。
*(细小、中等和粗糙结构)。
通常,所期望的是提供在大约60-85%之间的孔隙度。孔径尺寸通常可在大约50至1000微米的范围内。在上述示例中,所提供的最小孔径尺寸为大约300微米,并且最小窗在跨越其最大直径处为大约595微米。应当理解的是,所提供的该示例意图是非限制性的并且仅以说明为目的。
本文中所述的系统、方法和装置形成具有异形宏观结构和多孔微观结构的植入物,并且可以允许医学专业人员使用可定制的、患者特定的植入物。可以利用本文中所述的快速制造技术并通过将植入物的两个或更多个模型合并然后印刷建模的部件,而高效地形成定制的植入物。这可以允许医学专业人员(例如骨科外科医生)订购特定于单个患者的植入物,包括对植入物的尺寸和形状进行建模以与患者解剖结构的缺陷或者其它独特特征相符。也可以通过实施患者解剖结构的骨扫描或者利用其它可得到的医学成像和建模技术自动地创建用于快速制造的三维模型,而使此过程自动化。
定制单独植入物的能力也允许医学专业人员调节植入物的详细宏观结构和微观结构,以满足具体应用的需要。例如,骨科外科医生可以通过选择植入物表面上的突出部的形状、高度、密度或其它特征而调节植入物的宏观结构。外科医生也可以定制植入物内的空隙的数量和尺寸以实现期望的植入物孔隙度。在一些实施例中,外科医生也可以选择植入物的宏观结构的构造。对于包括用于强度和结构的内部实心部分的植入物而言,外科医生可以定制内部实心部分的尺寸和位置以提供在植入物的需要增加的强度的某些非均匀区域中的结构。示例性但非限制性的希望强度增加的示例区域包括螺钉孔附近的区域、加强件的赤道区域、加强件的连接部位、加强件的比其它区域更薄的区域、或者任何其它合适的区域。如果植入物的不同区域需要不同水平的摩擦或者用于骨界面的表面积,那么植入物的表面形貌也可以是非均匀的。外科医生可能需要在植入物的某些区域(例如经受更高水平的应力的区域)具有较高集中度的表面突出部,以及在其他区域具有较低集中度的突出部或者根本无突出部。
本文中所描述的多孔植入物允许植入物提供良好的接触表面区域和摩擦,而无论植入物所植入的骨的质量如何。例如,具有软的松质骨的患者会需要较长的特征物并且需要较低数量的这些特征物。具有硬致密骨的患者会需要较短的特征物但需要较多数量的这些特征物,以形成骨中的相同固定。可以通过由本文所述多孔植入物所提供的单独设计选项来适应患者解剖结构和骨质量的特定要求。
前述内容只是本公开的原理的例证,可以通过除本文所描述实施例以外的实施例来实施所述系统、装置和方法,本文所描述实施例是以说明为目的而不是限制性的。应该理解的是,虽然本文所公开的系统、装置和方法被示出用于髋臼系统中,但也可应用于其它外科手术所使用的医疗器械,其它外科手术包括但不限于脊柱成形术、颅颌面手术、膝关节成形术、肩关节成形术以及足、踝、手和四肢手术。
在研究了本公开之后,本领域技术人员将会想到各种变更和修改。可以用与本文中所述一个或多个其它特征的任意组合和亚组合(包括多种从属组合和亚组合)的方式来实施所公开的特征。以上所描述和说明的各种特征(包括其任何部件)可以组合或合并到其它系统中。另外,某些特征可以省略或者不实施。
本领域技术人员可发现本公开的变化、替换和变更的示例,可以在不背离本文所公开信息的范围的情况下做出变化、替换和变更。本文所引用的所有参考文献的全部内容以参考的方式并入本文中并且成为本申请的一部分。
Claims (18)
1.一种可植入骨科装置,包括:
植入物,所述植入物具有与患者骨关节接触的第一表面,
其中,所述第一表面包括多个突出部以及多个孔,所述多个孔分散在包括所述多个突出部以及在所述多个突出部之间的所述第一表面内且遍及包括所述多个突出部以及在所述多个突出部之间的所述第一表面。
2.如权利要求1所述的装置,其中,所述突出部是钝的。
3.如权利要求1和2中任一项所述的装置,其中,所述突出部升到所述第一表面之上的高度在50 μm和2000 μm之间。
4.如权利要求3所述的装置,其中,所述高度在100 μm和1100 μm之间。
5.如权利要求3所述的装置,其中,所述高度在200 μm和400 μm之间。
6.如权利要求1、2、4、5中任一项所述的装置,其中,所包括的所述多个突出部的集中度在0.25个突出部每平方毫米和6个突出部每平方毫米之间。
7.如权利要求1、2、4、5中任一项所述的装置,还包括沿所述植入物布置的或者布置在所述植入物内的加强肋。
8.如权利要求1、2、4、5中任一项所述装置,包括凸缘,所述凸缘具有附接到所述植入物的第一端以及包括用于附接到患者骨的通孔的第二端。
9.如权利要求1、2、4、5中任一项所述的装置,包括在所述植入物上的网状表面涂层。
10.一种用于制备可植入骨科装置的方法,所述方法包括:
提供模具,所述模具具有多孔带珠表面的负印痕;
提供将要被涂布的植入物衬底;
将颗粒插入所述植入物衬底与所述模具之间;以及
向所述模具、植入物衬底和颗粒施加压力或者升高的温度。
11.如权利要求10所述的方法,其中,所述植入物衬底是实心的或多孔的。
12.如权利要求10和11中任一项所述的方法,其中,所述颗粒是不对称的。
13.一种用于制备可植入骨科装置的方法,所述方法包括:
创建模拟多孔带珠植入物的外表面形貌的三维模型;
创建植入物衬底体积的三维模型;
将所述模拟多孔带珠植入物的外表面形貌的三维模型应用于所述植入物衬底体积的三维模型,以形成预形成体积;
应用算法以便用期望的网状结构填充所述预形成体积,以创建多孔植入物模型;以及
利用所述多孔植入物模型形成植入物。
14.一种用于制备可植入骨科装置的方法,所述方法包括:
提供具有内表面的植入物的模具,所述内表面模拟多孔带珠表面的外表面形貌几何形状的负像;
提供多个颗粒;
将所述多个颗粒放置在所述模具中;以及
向所述模具施加压力或者升高的温度。
15.如权利要求14所述的方法,其中,所述颗粒是不对称的。
16.一种用于制备可植入骨科装置的方法,所述方法包括:
提供具有内表面的植入物的模具,所述内表面模拟多孔带珠表面的外表面形貌几何形状的负像;
将一种或多种起泡剂装到所述模具中;
以所述植入物的大致形状或尺寸形成多孔泡沫部件,所述植入物具有模拟多孔带珠表面的外表面形貌几何形状的外表面几何形状;
从所述模具移除所述多孔泡沫部件;
将粘合剂施加到所述多孔泡沫部件;
将多个对称或不对称颗粒施加到其上具有粘合剂的所述多孔泡沫部件;
使其上具有粘合剂和颗粒的所述多孔泡沫部件经受升高的温度以将所述颗粒烧结到一起并烧尽所述泡沫部件以形成植入物,所述植入物具有粗糙化的多孔纹理,其具有模拟经过临床验证的多孔带珠结构的外表面形貌几何形状。
17.如权利要求16所述的方法,其中,所述多孔泡沫部件是聚合的。
18.如权利要求16和17中任一项所述的方法,其中,所述多孔泡沫部件是聚氨酯。
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