CN108601662B - 多孔脊柱融合植入物 - Google Patents
多孔脊柱融合植入物 Download PDFInfo
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- CN108601662B CN108601662B CN201680081857.8A CN201680081857A CN108601662B CN 108601662 B CN108601662 B CN 108601662B CN 201680081857 A CN201680081857 A CN 201680081857A CN 108601662 B CN108601662 B CN 108601662B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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Abstract
在一个方面中,本公开提供了一种外科植入物,该外科植入物包括:上骨接触表面,该上骨接触表面包括具有平均孔尺寸的多个不规则成形的孔,其中所述孔由多个支柱形成;下骨接触表面,该下骨接触表面包括具有平均孔尺寸的多个不规则成形的孔,其中所述孔由多个支柱形成;以及中央主体,该中央主体包括具有平均孔尺寸的多个不规则成形的孔,其中所述孔由多个支柱形成,其中所述上骨接触表面和所述下骨接触表面上的平均孔尺寸与所述中央主体上的平均孔尺寸不同。
Description
相关申请的交叉参考
本申请要求如下系列号的未决美国临时专利申请的优先权和权益:(i)2015年12月16日提交的No.62/268,430;和(ii)2016年6月23日提交的No.62/354,077;和(iii)2016年8月26日提交的62/379,988。
技术领域
主题公开总体上涉及脊柱植入物。
背景技术
背部问题是所有种族人们当中发生的最普遍、最令人衰弱的事情之一。仅在美国,每年就进行500,000多例脊柱腰椎和颈椎融合手术。背部疼痛和残障的原因之一是由于脊柱中的一个或多个椎间盘破裂或退化引起的。通常进行外科手术来校正由于创伤、疾病或老化引起的移位、损坏或退化的椎间盘。通常,脊柱融合术涉及移除一些或全部患病或损坏的椎间盘,并且将一个或多个椎间植入物插入到所得到的椎间盘空间内。利用人工植入物替换受伤或劣化脊柱骨需要脊柱中固有应力机构的知识以及身体响应于装置的生物学特性的知识之间的平衡。
发明内容
在一个方面中,本公开提供了一种外科植入物,该外科植入物包括:上骨接触表面,该上骨接触表面包括具有平均孔尺寸的多个不规则成形的孔,其中所述孔由多个支柱形成;下骨接触表面,该下骨接触表面包括具有平均孔尺寸的多个不规则成形的孔,其中所述孔由多个支柱形成;以及中央主体,该中央主体包括具有平均孔尺寸的多个不规则成形的孔,其中所述孔由多个支柱形成,其中所述上骨接触表面和所述下骨接触表面上的所述平均孔尺寸与所述中央主体上的所述平均孔尺寸不同。
在另一个方面中,本公开提供了一种外科植入物,该外科植入物包括:上骨接触表面;下骨接触表面;布置在所述上骨接触表面和所述下骨接触表面之间的中央主体,其中所述上骨接触表面和所述下骨接触表面具有从外周边向内部中央点减小的弹性模量。
附图说明
通过结合附图阅读该说明书,本领域技术人员将更清楚本主题公开的许多优点,附图包括:
图1A至图1D示出了根据主题公开的示例性实施方式的植入物的各种视图。
图2A至图2C示出了根据主题公开的示例性实施方式的植入物的设计的网格立体图。
图3示出了根据主题公开的示例性实施方式的植入物的多微孔端板的密度变化。
图4A至图4E示出了根据主题公开的示例性实施方式的植入物中的非均匀变化支柱形状。
图5至图12示出了根据主题公开的示例性实施方式的侧向植入物的各种立体图。
图13示出了图5至图11的侧向植入物的框架部件的立体图。
图14示出了图5至图12的侧向植入物的分解视图。
图15至图19示出了主题公开的侧向植入物的另选示例性实施方式。
图20至图25示出了主题公开的前植入物的示例性实施方式。
图26示出了主题公开的植入物的端板的另选示例性实施方式。
图27示出了主题公开的植入物的另一个另选示例性实施方式。
图28至图29示出了主题公开的植入物的另一个另选示例性实施方式。
图30至图31示出了主题公开的植入物的另一个另选示例性实施方式。
图32至图33示出了主题公开的植入物的另一个另选示例性实施方式。
具体实施方式
除非另有限定,否则这里使用的所有术语(包括技术术语和科技术语)都具有与本公开的领域中的技术人员所通常理解相同的含义。需要进一步理解,诸如那些在通用字典中限定的术语应该被解释为具有与它们在说明书上下文中的含义一致的含义,并且不应该以理想化或过于正式的意义进行解释,除非这里明确地进行了这样的限定。为了简洁或清晰起见,可能不详细描述公知功能或构造。
这里使用的术语仅仅为了描述具体实施方式之用,并且不是为了进行任何限制。如这里使用的,单数形式“一”、“一个”和“该”旨在也包括复数形式,除非上下文另有明确说明。
为了便于描述,这里可能使用空间相对术语,诸如“在…下面”、“在…下方”、“下”、“在…之上”、“上”等等以描述在设备正面朝上时一个元件或特征与另一个元件或特征的关系。
术语“大约”和“近似”应该泛指给定测量特性或精度的情况下对于所测量的量的可接收的误差或变化程度。典型地,示例性的误差或变化程度在给定值或值范围的百分之20(20%)内,优选在10%内,更优选在5%内。这里给出的数值量是近似的,除非另有说明,从而意味着在没有明确说明时也能够推断出属于“大约”或“近似”。
下面描述本发明的例示性实施方式。为了清楚起见,在该说明书中并不描述实际实现方案的所有特征。当然要认识到,在开发任何这种实际实施方式时,必须做出各种实现方案特定的决定,以便实现开发者的特定目的,诸如遵守系统相关和商业相关约束,这些约束对于不同的实现方案来说将是不同的。而且,要认识到,这种开发努力可能是复杂且耗时的,但是对于受益于本公开的本领域技术人员来说仍然是常规任务。这里公开的患者定位系统和相关方法自豪地拥有单独地或组合地保证专利保护的各种新颖特征和部件。
尽管主题内容可容易地进行各种修改和另选形式,但是在附图中以示例方式示出了主题内容的特定实施方式,并且这里详细地描述这些特定实施方式。然而,应该理解,这些对这些特定实施方式进行描述并不是为了将主题内容限制于所公开的具体形式,而是相反,该主题内容覆盖落入如这里限定的主题内容的精神和范围内的所有修改、等效物和另选形式。例如,这里描述的具体示例的任何一个特征都可以与这里公开的任何其他示例一起使用,而不会脱离本主题内容的范围。
本公开涉及一种脊柱融合植入物装置100,该植入物装置100具有上端板101、下端板102、融合孔口103、器具接合特征104,该器具接合特征104包括一个或多个接合特征105,诸如工具接收孔口。根据一个示例性实施方式,器具接合特征104包括被构造成接收诸如固定板、固定翼片或骨螺钉之类的固定元件的至少一部分的部分。另外,上端板101和下端板102具有多微孔端板结构110,并且装置100的位于上端板101和下端板102之间的内部部分(或中央主体130)具有大孔网格结构主体120。植入物100可以由任何生物相容材料构成。植入物100可以由单种生物相容材料构成,或者它可以由若干种生物相容材料构成(例如,器具接合特征104可以是与上多微孔端板101和下多微孔端板102不同的材料;大孔结构主体120可以是与上端板101和下端板102不同的材料,等)。
根据一个实施方式,植入物100由钛合金构成,并且拥有大孔主体网格结构120以有助于促进骨生长,这有助于在间隙内转化为快速初始稳定性。大孔主体网格结构120被设计成具有固有挠性,这种固有挠性有助于减少应力屏蔽并且减少植入物100下沉到植入该植入物的患者的椎骨内。
根据另一个实施方式,椎骨融合植入物100进一步包括由形成植入物的骨接触表面的柔性结构形成的多微孔端板结构110。该柔性结构允许植入物更好地相符于高度可变的人类椎骨端板形态。这种相符能力进一步增加了植入物100的稳定性,并且进一步增加了植入物100通过横跨植入物表面更好地进行载荷分布而减少植入物下沉到椎骨内的能力。自我调整的柔性结构允许植入物的骨接触表面定制而适合每个患者都不同的椎体端板的形态。可以想到,所述柔性结构可以以没有示出的另外方式构成,例如,从弹簧延伸出或者经由楔形件部署的柔性桁架、紧密压紧的柱,或者比金属椎间体具有更高挠性的医用等级弹性体。每种情况下的目标都一样,即实现植入物100和椎体端板表面之间的最佳配合。
这里描述的脊椎融合植入物100相比于传统系统拥有多个改进,包括增强的载荷分布和独特的端部匹配和相符表面。尽管在图1A至图4E中被示出为前椎间体装置,但是可以想到植入物100的大小和形状变化以适应对椎骨的颈部区域、胸部区域或腰部区域的所有的外科入路,包括直接侧向入路、前外侧入路、前侧入路、后侧入路和后外侧入路(参见例如图28至图33)。具有图示特征的椎间植入物100也是可能的。
图1A至图4E示出了一个实施方式,其中植入物100由合适的生物相容材料诸如钛合金构成,并且拥有大孔主体网格结构120,以帮助促进骨生长,该骨生长在椎间盘间隙内转化为快速初始稳定性。大孔主体网格结构120被设计成具有一定水平的固有挠性,该固有挠性有助于减少应力屏蔽和下沉。上端板101的轮廓与椎体端板的形状互补。尽管没有示出,可以想到下端板102为平坦而不是异型的另一个实施方式。
在图1A至图33中所示的某些示例性实施方式中,本公开为脊柱融合植入物100,该脊柱融合植入物100包含多尺度网格特征,诸如多微孔端板结构110和大孔主体网格结构120,多微孔端板结构110和大孔主体网格结构120增强了植入物100的机械特性和射线投射性以及生物响应性。如下的一般描述适用于图1A至图32中所示的所有实施方式。
如图1A所示,植入物100实施为多尺度结构设计,由具有多微孔端板结构110的上骨接触表面101和下骨接触表面102(或端板)、具有大孔主体网格结构120的位于上骨接触表面101和下骨接触表面102之间的中央主体部分130以及位于植入物的尾端并包括工具接合特征105的器具接合特征104构成。多微孔端板结构110和大孔主体网格结构120都由不规则且非均匀成形和尺寸的变化厚度的支柱140的网络构成。该支柱140网络限定不规则且非均匀成形和尺寸的非多边形孔150的系统。例如,如图3所示,支柱网络和对应孔的规模在多微孔端板结构110中小于大孔主体网格结构102。尽管植入物100的示例性实施方式包括融合孔口103,但是可以想到图示实施方式的另选实施方式不包括融合孔口103(即大孔主体网格包含植入物的位于多微孔端板之间的整个部分)。另外,可以想到,如下描述可以适用于成形为通过到椎间盘空间的任何已知外科入路例如直接侧向入路、前外侧入路、前侧入路或后侧入路植入到脊柱内的脊柱融合植入物装置。
一般设计构思涉及将多微孔端板110结合到图1A中所示的上骨接触表面101和下骨接触表面102,这允许在整个植入物100中形成连续孔隙度,即由多微孔端板形成的孔与由主体网格120的中央主体部分130形成的孔连通/接触。这允许骨不间断地结合到植入物100的微结构110和大孔结构120中。主体网格120允许基于患者特定载荷条件裁量并优化植入物100。此外,可以调整设计参数以表现出类似于骨的特性并促进骨结合。类似地,多微孔端板110的功能是在植入后立即促进骨生长到结构内。根据示例性实施方式,使用增材制造技术(包括但不限于3D打印)实现植入物100的生产。根据另选实施方式,使用增材制造和减材制造的组合制造植入物。
多尺度网格植入物100的部件包括:结构、机械和生物特征。该植入物可以由任何合适的生物相容金属材料、聚合材料和/或陶瓷材料构成。植入物100可以由单一生物相容材料构成,或者它可以由若干种生物相容材料构成(即,器具接合特征104可以是与上骨接触表面101和下骨接触表面102不同的材料)。根据一个实施方式,植入物100由钛合金构成。
图2A至图2C示出了大孔主体网格120可以通过使用包括优化算法的软件来设计,所述算法基于施加在植入物上的载荷条件(包括压缩、剪切和扭转111,参见图2B中的箭头)来载量所述结构。类似地,微孔结构110和/或主体网格结构120可以相对于孔大小、支柱厚度和/或表面粗糙度来进行功能分级。多微孔端板110可以在优到次方向、在中间到侧向方向上或优到次和中间到侧向的组合来进行功能分级。根据一个实施方式,上骨接触表面101和下骨接触表面102的孔隙度可以进行功能分级以允许从微孔到大孔网格的过渡是连续的。另选地,从微孔端板到大孔端板的过渡可以是明显的。此外,多微孔端板的刚度等级将允许与骨接触的区域挠曲和变形,以更好地相符个别患者的独特椎骨端板形态。这可获得分布载荷和降低下沉可能性的双重好处。
根据图26中所示的示例性实施方式,多微孔端板结构110从上骨接触表面101和下骨接触表面102的周边朝向上骨接触表面101和下骨接触表面102的中央孔隙度降低。根据图27中所示的示例性实施方式,大孔网格主体结构120的孔的孔隙度围绕植入物100的周边增加,而朝向植入物100的中央减小。在图26和图27所示的两个实施方式中,孔隙度的变化可以是渐进的,或者另选地该变化可以是阶梯式的。
在一个实施方式中,对多微孔端板结构110进行裁量以表现出与人骨相比较小或相同范围的弹性模量(例如,在0.2GPA至30GPa之间),以促进骨生长并降低应力屏蔽。根据另选示例性实施方式,整个植入物100的体积弹性模量小于或等于人骨的范围范围(0.2GPa到30GPa)。根据另一个示例性实施方式,裁量上骨接触表面101和下骨接触表面102以具有与特定患者自身骨匹配或与特定患者自身骨在相同范围内的弹性模量。根据又一个示例性实施方式,裁量整体植入物以具有与特定患者自身骨匹配或与特定患者自身骨在相同范围内的弹性模量。根据使用增材制造技术生产的植入物100的示例性实施方式,植入物设计软件包括可以应用于植入物100以便产生低密度、节省材料的植入物的优化算法。这是通过在设计程序中向植入物100施加多个临床相关的载荷条件并且允许有限元解算器优化并细化如图2A所示的植入物100的主体网格结构完成的。通过增加植入物100的射线可透性从而允许人们更好地观察骨生长到植入物100中,被优化而移除材料的植入物100可以有益于临床医生。
在替换实施方式中,上骨接触表面101和下骨接触表面102可以具有不同弹性模量的区域。例如,上骨接触表面101和下骨接触表面102在插入之后与相邻椎体的皮质区域接触的外部区域可以具有第一弹性模量,而上骨接触表面101和下骨接触表面102在插入之后与相邻椎体的网状骨质区域接触的内部区域可以具有第二弹性模量。在一个实施方式中,第一弹性模量可以为大约6GPa,而第二弹性模量为大约3GPa。
上端板101和下端板102由多微孔端板结构110形成,该多微孔端板110使孔150尺寸、孔150体积、支柱140厚度和表面粗糙度设计成促进生长并在植入部位处引发成骨响应。根据一个示例性实施方式,多微孔端板110中的孔150的直径范围从100μm到1500μm,并且支柱140的厚度范围从100μm到500μm。在一些实施方式中,多微孔端板110中的孔140的尺寸范围从300μm到1200μm,并且支柱140的厚度尺寸范围从150μm到300μm。在一个示例性实施方式中,孔150的平均直径为500μm,而支柱140平均厚度为200μm。根据另选实施方式,孔150平均直径为800μm,而支柱140的平均厚度为200μm。根据另一个示例性实施方式,形成上骨接触表面101和下骨接触表面102的多微孔端板110的孔150在周边处具有500μm的平均直径,并且孔150朝向上骨接触表面101和下骨接触表面102的中央过渡到800μm的平均直径。该过渡可以是渐进的或离散的。根据这些示例性实施方式,多微孔端板101、102具有包括从端板表面一直延伸到300μm的大表面粗糙度和包括深度范围从0.45μm到7μm的表面纹理的纳米/微表面粗糙度。
如上所述,从多微孔端板结构110到大孔结构120的过渡可以是离散的(即,在这些结构之间没有重叠),渐进的(即,多微孔结构110的孔150的平均尺寸逐渐增加至大孔网格结构120中发现的孔150的平均尺寸)或者在这些结构之间可以有一些重叠(即,大孔网格结构120可以延伸到多微孔端板结构110内)。
在一个实施方式中,该过渡为其中大孔网格结构120延伸到多微孔端板结构10内一定深度d的重叠。该重叠深度d可以根据具体植入物的必要设计要求而改变。在一些实施方式中,这些结构之间的重叠是指深度d在多微孔端板结构110的厚度的5%到95%之间。例如,如果多微孔结构110具有大约1000μm的厚度,则深度d可以在5μm至950μm之间。在一个实施方式中,深度d为多微孔结构110的厚度的25%至75%之间,而在一个优选实施方式中,深度d为多微孔结构110的厚度的大约50%至66%。例如,如果多微孔端板结构110具有1000μm的厚度,则深度d将为大约500μm至660μm。如这里描述的,多微孔端板结构110的厚度能够在上端板101和下端板102的不同区域中改变也是可行的。在这些实施方式中,深度d还可以在不同厚度的区域中改变。如果上端板101的第一区域具有1,000μm厚度的多微孔结构110,则深度d可以为大约500μm至660μm,而在具有1,500μm的上端板101的相邻区域,深度d则可以为大约750μm至1,000μm。另选地,深度d可以恒定,而不管多微孔端板结构110或多微孔端板结构110的具体区域的厚度如何。
中央主体部分130的大孔网格结构120的孔150在X、Y和Z平面中的每个平面中都具有从2mm到10mm的尺寸范围,并且支柱140的厚度尺寸范围从0.3mm到5mm。根据示例性实施方式,孔150为大约5.5mm×5.5mm×4mm,其中支柱140的厚度范围从0.5mm到2mm。包括主体-网格结构120的各个支柱140为非平面的、不规则的,并且不是根据规则或重复图案放置的。支柱140的厚度在各个支柱140的整个长度都是变化的,换言之,各个支柱140横跨支柱140具有不同厚度。根据这些示例性实施方式,大孔网格主体120具有包括深度范围从0.45μm到7μm的表面纹理的表面粗糙度。在图4A所示的实施方式中,各个支柱140在支柱140的每个端部(即,在该端部处,各个支柱140终止和/或连接至另一个单独支柱140)处具有比支柱140的中间部分更大的厚度。根据图4A所示的示例性实施方式的另一个方面,每个支柱140的最小和最大厚度可以每个支柱都不同。
植入物100可以包括纹理化表面涂层160以进一步促进骨生长到植入物100上。该纹理化表面涂层160可以是陶瓷涂层,诸如磷酸钙或生物相容金属涂层。在一些实施方式中,该纹理化表面涂层160被施加至多微孔端板结构110。在其它实施方式中,该纹理化表面涂层160被施加至大孔网格主体结构120。在还有其它实施方式中,该纹理化表面涂层160被施加至整个植入物100。
图5至图14示出了示例性侧向脊柱融合植入物100的各种视图。该植入物100具有由多微孔端板结构110形成的上表面101和下表面102以及由主体网格结构120形成的中央主体部分130。植入物100具有前端170和相反的尾端180以及从上骨接触表面101穿过植入物100延伸至下骨接触表面102的融合孔口103。尾端180包括器具接合孔口104,该器具接合孔口104包括用于接合插入工具的至少一个接合部分105。前端170可以是锥形的,以方便插入到椎间盘空间内。在另选实施方式中,前端170的至少一部分是实心的。根据该示例性实施方式,植入物100从前端170到尾端180的长度在从45mm到65mm的范围内,植入物100的前后宽度尺寸在18mm到26mm的范围内,并且脊柱前凸角在0°到15°的范围内。还可以想到,本公开的植入物100可以具有从15°到40°的过度脊柱前凸角。
根据图5至图14中的实施方式的脊柱融合植入物进一步包括植入物框架190。植入物框架190可以包括将上接触表面101和下接触表面102的外周边和内周边分界的实心缘。在该实施方式中,沿着上接触表面101和下接触表面102的内部的实心缘形成了融合孔口103的边界。
在一些实施方式中,植入物100包括位于植入物100的中间平面内的至少一个不透射线标记200。在一些实施方式中,植入物100包括位于中间平面中的至少两个不透射线标记200。可以进一步想到,本公开的植入物100可以与联接至该植入物100的尾端180的固定板一起使用,并且包括贯穿的用于接收固定元件的至少一个固定孔口,从而在固定板联接至该植入物100时,该固定孔口位于椎体侧方邻近。在一些实施方式中,固定板包括两个固定孔口,一个固定孔口将相邻于上椎体侧方,并且另一个固定孔口将相邻于下椎体侧方。
图15至图19示出了侧向植入物的另选实施方式,该侧向植入物具有针对图8至图10描述的所有相同特征,但是不包括框架190。
图20至图25示出了尺寸设置成通过前侧入路插入椎间盘空间内的前侧植入物100的示例性实施方式。图20至图25的植入物具有由多微孔端板结构110形成的上表面101和下表面102以及由主体网格结构120形成的中央主体部分130。该植入物具有前端170和相反的尾端180以及从上骨接触表面101穿过植入物100延伸至下骨接触表面102的融合孔口103。尾端180包括器具接合特征104,该器具接合特征104包括用于接合插入工具的至少一个接合部分105。根据该示例性实施方式,植入物100具有在0°到15°的范围内的脊柱前凸角。还可以想到,主题公开的脊柱融合植入物的示例性实施方式具有15°到40°的过度脊柱前凸角。根据一个示例性实施方式,植入物100包括植入物框架190。
图28至图29和图32至图33示出了尺寸设置成经由前侧入路插入椎间盘空间内的前侧植入物100的另选实施方式。根据该实施方式的植入物包括图20至图25中所示并与以上描述的植入物相同的全部基本结构特征,并且进一步包括器具接合特征104,该器具接合特征104包括固定孔口106。尽管在图28至图29中被示出为具有三个孔口,并且在图32至图33中被示出为具有两个孔口,但是可以想到植入物具有至少一个固定孔口。根据这些示例性实施方式,固定孔口的尺寸设置成用来接收骨螺钉。此外,尽管被示出为具有融合孔口103和框架190,可以想到另选实施方式,其中植入物不具有融合孔口(即,大孔网格主体在多微孔端板之间是连续的,多微孔端板也是连续的)和/或植入物不包括框架。
图30至图31示出了尺寸设置成通过后侧入路插入椎间盘空间内的后侧植入物的另一个另选实施方式。根据该实施方式的植入物包括与图1A至图27中所描述的植入物相同的全部基本结构特征,包括第一多微孔端板101和第二多微孔端板102、大孔网格主体120和器具接合特征104。
根据一个示例性实施方式,该植入物可以通过将该植入物分离成分开结构,设计和/或优化这些结构并且将它们组合以在单个构建过程中进行打印而制成。根据一个实施方式,该植入物被设计为包括主体网格和多微孔端板的两个分开结构。根据该实施方式,将主体网格结构优化以针对所制造的每个植入物尺寸产生有效的强度比重量结构。所述植入物尺寸都进行优化以通过特定最大容许网格应力承受相同载荷条件,从而使每个植入物尺寸都得到独特的主体网格结构。
根据示例性实施方式,每个植入物部件(例如,主体网格和多微孔端板)使用建模软件程序设计。然后,通过向该植入物应用特定理论载荷条件使用有限元分析和优化算法对网格主体结构进行优化(例如,按照需要确定每个网格支柱的厚度,以便使强度最大化并且使结构材料最少)。多微孔端板的设计被限定为实现期望结构,并且所述端板与优化主体网格组合以产生组装好的装置。将最终装置组件输出为.STL文件,并且准备好利用3D打印机器进行构建。
根据另选实施方式,制造植入物的方法进一步包括如下步骤:设计器具接合特征以实现期望设计;和将所述器具接合特征与多微孔端板和优化网格主体组合,之后将装置部件输出为.STL文件并准备好利用3D打印机器进行构建。根据一个方面,在将装置打印出来之后在器具接合特征中机加工附加特征,诸如孔口。
根据另一个另选实施方式,制造植入物的方法进一步包括如下步骤:设计缘以实现期望结构;将其与多微孔端板和优化网格主体组合(具有或不具有器具接合特征);将最终装置部件输出为.STL文件并且准备好利用3D打印机器构建所述植入物。
为了例示和描述的目的,已经提供了本主题公开的示例性实施方式的上述公开。并不是为了穷尽该主题公开或者将该主题公开限制于所公开的精确形式。鉴于上述公开,这里描述的实施方式的许多改变和修改对本领域技术人员来说都是显而易见的。主题公开的范围仅由所附权利要求及其等同物来限定。
另外,在描述本主题公开的代表性实施方式中,说明书可能已经将本主题公开的方法和/或过程展现为具体的步骤序列。然而,从该方法或过程不依赖这里阐述的特定步骤顺序这一方面来说,所述方法或过程不应该限于所描述的特定步骤序列。如本领域技术人员将认识到的,其它步骤序列也是可行的。因此,说明书中阐述的特定步骤顺序应该被解释为对权利要求的限制。另外,涉及本主题公开的方法和/或过程的权利要求不应该限于以书写顺序来执行它们的步骤,本领域技术人员能够容易地认识到所述序列可以改变并且仍然保留在本主题公开的精神和范围内。
Claims (9)
1.一种外科植入物,该外科植入物包括:
i.上骨接触表面,该上骨接触表面包括具有平均孔尺寸的多个不规则成形的孔,其中所述上骨接触表面的所述孔由多个支柱形成;
ii.下骨接触表面,该下骨接触表面包括具有平均孔尺寸的多个不规则成形的孔,其中所述下骨接触表面的所述孔由多个支柱形成;以及
iii.中央主体,该中央主体包括具有平均孔尺寸的多个不规则成形的孔,其中所述中央主体的所述孔由多个支柱形成,
其中所述上骨接触表面和所述下骨接触表面上的所述平均孔尺寸与所述中央主体上的所述平均孔尺寸不同,
其中,所述上骨接触表面、所述下骨接触表面和所述中央主体具有弹性模量,并且所述中央主体的弹性模量与所述上骨接触表面和所述下骨接触表面的所述弹性模量不同,并且
其中,所述上骨接触表面和所述下骨接触表面的所述弹性模量从外周边向内部中央点减小。
2.根据权利要求1所述的外科植入物,其中,所述上骨接触表面和所述下骨接触表面的平均孔尺寸小于所述中央主体的平均孔尺寸。
3.根据权利要求1所述的外科植入物,其中,所述上骨接触表面和所述下骨接触表面的平均孔尺寸在100微米至1500微米之间。
4.根据权利要求3所述的外科植入物,其中,所述上骨接触表面和所述下骨接触表面的平均孔尺寸为大约500微米。
5.根据权利要求1所述的外科植入物,其中,所述弹性模量从所述外周边向所述内部中央点以阶梯形式变化。
6.根据权利要求1所述的外科植入物,该外科植入物进一步包括融合孔口。
7.根据权利要求1所述的外科植入物,该外科植入物进一步包括植入物框架。
8.根据权利要求1所述的外科植入物,该外科植入物进一步包括一个或多个不透射线标记。
9.根据权利要求1所述的外科植入物,其中,所述外科植入物的所述上骨接触表面相对于所述外科植入物的所述下骨接触表面的角度为0度到40度。
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CN108601662A (zh) | 2018-09-28 |
EP3389570A1 (en) | 2018-10-24 |
JP7301111B2 (ja) | 2023-06-30 |
AU2016369593B2 (en) | 2021-04-01 |
US20200261243A1 (en) | 2020-08-20 |
KR20180095853A (ko) | 2018-08-28 |
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