CN109906064B - 针对骨缺损的折叠容纳装置 - Google Patents
针对骨缺损的折叠容纳装置 Download PDFInfo
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Abstract
本发明提供了一种包括二维网状片材的骨移植物***,该二维网状片材的尺寸和形状被设定成当沿着折叠线折叠时形成三维移植物容纳结构,该三维移植物容纳结构被构造成填充有骨移植材料以放置在骨的目标区域内,该网状片材包括:第一端部翼片,所述第一端部翼片经由第一折叠线连接到该网状片材的剩余部分;以及第二端部翼片,所述第二端部翼片经由第二折叠线连接到该网状片材的剩余部分,第三折叠线从第一折叠线延伸至第二折叠线,使得剩余部分被构造成包裹折叠好的第一端部翼片和第二端部翼片,以形成移植物容纳结构,第一端部翼片和第二端部翼片基本上对应于骨的目标区域的轮廓。
Description
优先权声明
本申请要求于2016年11月3日提交的美国临时专利申请序列号62/417,052的优先权。上述申请的全部公开内容以引用方式明确地并入本文。
背景技术
通常用骨移植物和/或植入物诸如骨板来治疗下颌缺损,以帮助愈合。可使用多种方法中的任一种将骨移植物放置在目标区域中。然而,在没有用于骨移植物的容器的情况下,移植物在其可被身体结合到愈合骨中之前可远离目标部位。
发明内容
本发明涉及包括二维网状片材的骨移植物***,该二维网状片材的尺寸和形状被设定成当沿着折叠线折叠时形成三维移植物容纳结构,该三维移植物容纳结构被构造成填充骨移植材料以放置在骨的目标区域内,该网状片材包括:第一端部翼片,该第一端部翼片经由第一折叠线连接到该网状片材的剩余部分;以及第二端部翼片,该第二端部翼片经由第二折叠线连接到网状片材的剩余部分,第三折叠线从该第一折叠线延伸至该第二折叠线,使得该剩余部分被构造成包裹折叠好的第一端部翼片和第二端部翼片,以形成该移植物容纳结构,该第一端部翼片和该第二端部翼片基本上对应于该骨的目标区域轮廓。
本公开还涉及包括移植物容纳组件的骨移植物***,该移植物容纳组件包括多个二维网状片材,该多个二维网状片材沿着其纵向边缘而彼此连接,每个该网状片材的尺寸和形状被设定成使得当沿着折叠线折叠时,该网状片材中的每个形成三维移植物容纳结构,该三维移植物容纳结构被构造成填充骨移植材料,每个移植物容纳结构相对于相邻的移植物容纳结构可移动,以形成所需构型的该移植物容纳组件,用于将该移植物容纳组件放置在骨的目标区域内。
本公开还涉及用于治疗骨的方法,包括:沿着折叠线折叠第一二维网状片材以形成第一三维移植物容纳结构,该第一网状片材包括:第一端部翼片,该第一端部翼片经由第一折叠线连接到网状片材的剩余部分;以及第二端部翼片,该第二端部翼片经由第二折叠线连接到网状片材的剩余部分,第三折叠线从第一折叠线延伸至第二折叠线,使得剩余部分被构造成包裹折叠好的第一端部翼片和第二端部翼片,以形成第一移植物容纳结构;用骨移植材料填充该第一移植物容纳结构;使该第一移植物容纳结构保持成闭合构型,使得该骨移植材料保持在其中;将该第一移植物容纳结构定位在骨的目标区域内;以及将该第一移植物容纳结构固定到该骨上。
附图说明
图1示出了根据本公开的示例性实施方案的***的俯视平面图;
图2示出了图1的***的透视图;
图3示出了图1的***的另一个透视图;
图4示出了处于折叠构型中的图1的***的透视图;
图5示出了根据本公开的另一个示例性实施方案的***的俯视平面图;
图6示出了处于折叠构型中的图5的***的透视图;
图7示出了根据本公开的又一个示例性实施方案的***的透视图;
图8示出了根据图7的***的网状片材的透视图;
图9示出了处于折叠构型且定位在骨的目标区域中的图7的***的俯视平面图;
图10示出了处于折叠构型且定位在骨的目标区域中的图7的***的透视图;以及
图11示出了根据图7的***的移植物容纳结构的横截面侧视图。
具体实施方式
可参考以下的描述和附图理解本发明,其中相同参考标号指代类似元件。本发明涉及骨的治疗,并且具体地涉及使用骨移植物和骨移植替代物而进行的治疗。本发明的示例性实施方案描述了一种移植物容纳保持架,该移植物容纳保持架被构造成定位在目标骨(例如,下颌)中的间隙或空间中,使得移植材料可填充在其中以促进和引导间隙/空间中的新骨的产生。在一个示例性实施方案中,保持架可定位在骨的两个分离部分之间以产生接合骨的分离部分的新骨。然而,本领域的技术人员应当理解,移植物容纳保持架可***或定位在目标骨的任何间隙或空间内,包括例如在骨的端部处,使得只有在移植物容纳保持架的一侧上有骨,或者在骨的凹入空间内,使得移植物容纳保持架的三个侧面接触骨。示例性实施方案中的移植物容纳装置成形为二维网状片材,该二维网状片材的尺寸和形状被设定成折叠成三维结构,该三维结构的形状基本上对应于待填充的凹槽或空间的形状。可以将骨移植材料或骨移植替代材料填充到三维结构之内。在一个实施方案中,移植物容纳装置的尺寸、形状和结构被设定成治疗下颌的缺损。尽管示例性实施方案被示出和描述为在治疗下颌中使用,但本领域的技术人员应当理解,本发明的移植物容纳装置也可按不同形状形成,并且其尺寸经设定,允许其用于治疗将从使用移植物容纳装置中受益的其它类型的骨。
如图1-4所示,根据本公开的示例性实施方案的***100包括二维网状片材102,其尺寸和形状被设定成沿折叠线106折叠,如图1所示,以形成三维移植物容纳结构104,如图4所示,三维移植物容纳结构被构造成***骨的目标区域中(例如,以置换下颌的一部分)。网状片材102的尺寸和形状经具体的设定,使得当折叠时,移植物容纳结构104可定位在目标区域B中,例如,先前被切除的骨占据的空间中。例如,目标区域可位于已被移除的骨的一部分的任一侧上的骨的端部。移植物容纳结构104的每一端部可基本上对应于骨的分离部分的端部中的相对应一个端部的外表面轮廓,使得移植物容纳结构104桥接骨的两个分离部分。移植材料可填充在移植物容纳结构104的内部以促进骨的分离部分之间的骨生长,如本领域的技术人员将会理解的那样。
如图1所示,网状片材102包括多条折叠线106,网状片材102沿着折叠线106具体地被构造成沿着这些折叠线折叠,以形成移植物容纳结构104,如图4所示。网状片材102限定:第一表面122,当网状片材102折叠成移植物容纳结构104时,第一表面形成移植物容纳结构104的内部;和第二表面124,当网状片材102折叠成移植物容纳结构104时,第二表面形成移植物容纳结构104的外部。网状片材102还限定第一边缘108和相对的第二边缘110,使得当网状片材102沿折叠线106进行折叠时,所得的移植物容纳结构104沿着纵向轴线从对应于第一边缘108的第一端部112延伸至对应于第二边缘110的第二端部114。折叠线106可形成为例如活动铰链,从而有利于网状片材102沿其折叠。
在一个实施方案中,网状片材102包括至少三条折叠线106,该至少三条折叠线106将网状片材102分成多个区段,该区段限定了移植物容纳结构104的不同表面。网状片材102的形状可被设定成包括第一端部翼片116和第二端部翼片118,每个翼片经由折叠线106中的一条折叠线连接到网状片材102的剩余部分120。具体地讲,第一端部翼片116经由折叠线中的第一折叠线106a连接到网状片材102的剩余部分120,并且第二端部翼片118经由折叠线中的第二折叠线106b连接到剩余部分120。第一端部翼片116和第二端部翼片118可分别沿着第一折叠线106a和第二折叠线106b,朝第一表面122折叠。当折叠时,第一端部翼片116和第二端部翼片118横向于移植物容纳结构104的纵向轴线延伸,以分别限定移植物容纳结构104的第一端部112和第二端部114。在一个示例中,第一端部翼片116和第二端部翼片118折叠,以基本上垂直于移植物容纳结构104的纵向轴线延伸。如本领域的技术人员将会理解的,第一端部翼片116和第二端部翼片118中每个翼片的形状通常可成形为对应于骨的分离部分的外表面的轮廓。
折叠线中第三折叠线106c从第一边缘108延伸至第二边缘110,并连接第一折叠线106a和第二折叠线106b。因此,在沿着第一折叠线106a和第二折叠线106b折叠网状片材102之后,可沿着第三折叠线106c折叠网状片材102(图2),并可以使剩余部分120包裹折叠好的第一端部翼片116和第二端部翼片118(图3),使得第一表面122围绕第一端部翼片116和第二端部翼片118的周边延伸,分别与其边缘130,132接触,以在容纳结构104(图4)内形成可在其中保持移植材料的基本上封闭的空间。如本领域的技术人员将会理解的,在折叠网状片材102期间或之前,移植物容纳结构104可填充有移植材料。移植物容纳结构104可以多种方式中的任一种保持成闭合构型。例如,移植物容纳结构104可经由缝合和/或钩挂来闭合。
在另一个实施方案中,网状片材102包括经由第四折叠线106d连接到网状片材102的剩余部分120的重叠部分126。当沿第四折叠线折叠时,重叠部分126与剩余部分120的一部分重叠,以有利于移植物容纳结构104的闭合。可将该重叠部分126缝合或以其它方式附接到剩余部分120以使移植物容纳结构104保持成闭合构型,从而将移植材料保持在其中。
网状片材102的形状可被设定成使得在一个实施方案中,在折叠过程完成之后,移植物容纳结构104包括在第一端部112和第二端部114中每个端部处的悬伸部128。换句话讲,网状片材102的一部分可延伸超过折叠好的第一翼片116和第二翼片118中的每个翼片,使得当移植物容纳结构104定位在骨的目标区域之中时,悬伸部128延伸超出骨的分离部分的端部。悬伸部128可经由例如骨固定元件附连到骨,以相对于骨固定移植物容纳结构104。
网状片材102可以按多种形状和尺寸制造,使得外科医生或其它使用者可选择最适于治疗目标骨的所需尺寸和形状。另外地或另选地,外科医生或其它使用者可修剪网状片材102以获得更适合正进行治疗的那部分目标骨的移植物容纳结构104。例如,可修剪悬伸部128的多个部分、和/或第一端部翼片116和第二端部翼片118以实现所需的贴合度。网状片材102可包括例如分割线形式的修剪线以引导其正确的修剪。
网状片材102可由诸如吸收性聚合物(例如PCL)或不可再吸收聚合物、金属(例如钛)、或复合材料(例如石墨烯、弹性体)等材料形成,这取决于正进行治疗的解剖区域和指示。网状片材102可包括延伸穿过其材料的多个孔,这些孔的形状被设定成促进骨的血管形成,同时防止填充在移植物容纳结构104中的移植材料脱落。孔的尺寸和形状也可被设定成在其中接纳固定元件。在一个示例中,孔的尺寸可被设定成接纳直径为1.8mm的固定螺钉。在另一个实施方案中,网状片材102可经由由所需材料形成的多个相交撑条形成,撑条相交以限定孔。
根据示例性方法,网状片材102被构造成沿折叠线106折叠以形成移植物容纳结构104。具体地讲,朝第一表面122向内折叠第一端部翼片116和第二端部翼片118,直到第一端部翼片116和第二端部翼片118基本上相对于网状片材102的剩余部分120垂直。该剩余部分120包裹第一端部翼片116和第二端部翼片118的周边,使得第一表面122表面分别接触第一翼片和第二翼片的边缘130、132。如果需要,可在网状片材102折叠之前修剪网状片材102,以更好地贴合正进行治疗的骨的目标区域。当网状片材102被折叠成所需的形状时,移植材料可被填充到移植物容纳结构104中。一旦已完成网状片材102的折叠,移植物容纳结构104就形成移植材料保持在其中的基本上封闭的空间,从而防止移植材料从其中脱落。可对彼此接触以形成移植物容纳结构104的网状片材102的边缘和/或表面进行缝合、钩挂或以其它方式附接以保持移植物容纳结构的形状。
一旦移植物容纳结构104呈所需的形状并填充有移植材料,根据需要,移植物容纳结构104可被放置在目标骨的两个部分之间的凹槽或间隙中的所需位置中。例如,移植物容纳结构104可被定位成使得移植物容纳结构104的第一端部112和第二端部114基本上与骨的分离端部部分对齐。如果需要,可进一步修剪移植物容纳结构104,以有助于将移植物容纳结构104定位在骨的目标区域中。在一个实施方案中,移植物容纳结构104的第一端部112和第二端部114之处的悬伸部128可与骨的分离部分的端部重叠。这些悬伸部128可经由例如骨固定元件诸如骨螺钉固定到骨。移植物容纳结构104也可经由骨板固定到骨,该骨板沿移植物容纳结构104的长度延伸,使得骨板的端部延伸超出骨的分离部分的端部。骨板可固定到移植物容纳结构104和骨。
尽管示例性实施方案描述了使用单个移植物容纳结构104来治疗目标区域,但可利用多个移植物容纳结构104来治疗目标区域。然而,这可能需要修剪网状片材102和/或移植物容纳结构104以贴合目标区域。在一个实施方案中,移植物容纳结构104可端对端彼此附接,以形成用于治疗目标区域的所需长度和/或曲率。
根据另一个示例性实施方案,如图5和图6所示,***200可基本上类似于上述***100,该***100包括网状片材202,该网状片材202被构造成沿着折叠线206a、206b进行折叠,以形成移植物容纳结构204。然而,移植物容纳结构204可具体地使用三维数字环境进行设计以匹配患者的特定骨尺寸,该特定骨尺寸可通过例如目标骨的3D成像获得。具体地讲,3D扫描可用于生成具有所需尺寸的移植物容纳结构204诸如长度、曲率、和横截面积。这些尺寸被用于设计虚拟3D形状,该虚拟3D形状然后可转换为数字二维设计以构建患者专用网状片材202。***200可以将***100的网状片材102用作网状片材202的二维模板。使用所需尺寸的移植物容纳结构204和网状模板,来构造患者专用网状片材202。网状片材202的尺寸和形状根据所需尺寸进行具体设定,其成形为包括折叠线206a、206b,使得当沿着折叠线206a、206b折叠时,形成具有所需尺寸的移植物容纳结构204。
网状片材202可基本上类似于上文中关于***100所述的网状片材102。网状片材202可包括弯曲的纵向边缘234、236和相对的第一横向边缘208和第二横向边缘210,当其从纵向边缘中的第一边缘234朝纵向边缘中的第二边缘236延伸时,第一横向边缘和第二横向边缘相对于彼此逐渐变细。网状片材202还可包括附加折叠线206a、206b和狭缝238,用以沿着这些部分折叠时,实现移植物容纳结构204的所需曲率和形状。
在一个实施方案中,网状片材202被具体地构造成治疗患者的下颌。类似于网状片材102,该网状片材202包括第一端部翼片216和第二端部翼片218,当折叠时,第一端部翼片和第二端部翼片分别限定移植物容纳结构204的第一端部212和第二端部214。第一端部翼片216和第二端部翼片218的尺寸和形状被具体地设定成对应于患者下颌的目标区域的轮廓。纵向延伸的折叠线206a被设计成使得,当沿其折叠时,所得的移植物容纳结构204具有所需的横截面积,用于治疗患者下颌的目标区域。网状片材202还包括沿其延伸的狭缝238,该狭缝238与横向延伸的折叠线206b的一部分对齐,使得在折叠时,经由横向延伸的折叠线206b而彼此分离的网状片材202的相邻部分240可以相对于彼此弯曲以获得具有所需曲率的移植物容纳结构204。
与网状片材102相似,网状片材202的形状也可经设定,使得当折叠时,移植物容纳结构204包括延伸超过折叠好的第一端部翼片216和第二端部翼片218的悬伸部228。悬伸部228可延伸超出骨的分离部分的端部,使得可经由这些悬伸部228将移植物容纳结构204固定到骨。
***200可以基本上与上文关于***100所述相同的方式使用。具体地讲,网状片材202可沿折叠线206a、206b折叠以构造患者专用移植物容纳结构204。在网状片材202的折叠期间,移植物容纳结构204可填充有移植材料。如上文所述,移植物容纳结构204将具有所需尺寸、截面形状和曲率,用于治疗患者的目标区域。
如图7-11所示,***300可基本上类似于上述***100、200。然而,***300包括移植物容纳组件301,该移植物容纳组件包括沿着其第一纵向边缘334彼此连接的多个网状片材302,如图7所示。网状片材302中的每一网状片材可基本上类似于网状片材102、202,并且可单独折叠以形成移植物容纳结构304,这些移植物容纳结构一起形成用于治疗患者的骨的目标区域的移植物容纳装置303。由于在折叠网状片材302之后,网状片材302沿着第一纵向边缘334连接,每个所得的移植物容纳结构304可相对于彼此进行定位/取向,以获得具有所需曲率的组件301以贴合骨的目标区域。与***200类似,***300可具体地使用三维数字环境进行设计以匹配患者的特定骨尺寸,特定骨尺寸可通过例如目标骨的3D成像获得。具体地讲,3D扫描可用于生成具有所需尺寸的移植物容纳组件301诸如长度、曲率、和横截面积。然后将这些尺寸转换为数字二维设计以构建患者专用网状片材302,其可被折叠以形成所需的移植物容纳结构304的组件。另选地,***300或所述实施方案的任一***可制成标准尺寸,医师可根据任何已知的一种或多种方式对其进行修剪、弯曲或以其它方式定制以适合个体患者。
如图8所示,网状片材302中的每一网状片材可基本上类似于上文关于***100所述的网状片材102。每个网状片材302是二维的并经由第一表面322和第二表面324进行限定,当朝向移植物容纳结构304折叠网状片材302时,第一表面形成移植物容纳结构304的内部,当朝向移植物容纳结构304折叠网状片材302时,第二表面形成移植物容纳结构的外部。每个网状片材302还可经由第一纵向边缘334和第二纵向边缘336、以及第一横向边缘108和第二横向边缘110进行限定。与网状片材102类似,每个网状片材302的尺寸和形状被设定成沿折叠线306折叠,以形成具有所需移植物容纳结构304的移植物容纳组件301。移植物容纳结构304中的每一个可填充有移植材料,使得移植物容纳组件301可被放置在目标区域内以促进骨生长和愈合。具体地讲,每个网状片材302包括第一端部翼片316和第二端部翼片318,该第一端部翼片316和第二端部翼片318分别经由第一折叠线306a和第二折叠线306b连接到每个网状片材302的剩余部分320。当网状片材302被折叠时,第一端部翼片316和第二端部翼片318可分别形成移植物容纳结构304的第一端部312和第二端部314。
网状片材302可包括第三折叠线306c,沿着该折叠线,可折叠剩余部分320,使剩余部分320包裹第一端部翼片316和第二端部翼片318的周边。网状片材302可被折叠以形成基本上与上文针对***100所述相同的移植物容纳结构304。在折叠过程中,可在组件301的每个移植物容纳结构304内填充移植材料。尽管示例性实施方案示出和描述了三条折叠线306,本领域的技术人员应当理解,网状片材302可包括多于三条折叠线306以形成例如类似于网状片材102的重叠部分。
本领域的技术人员应当理解,每个网状片材302可具有不同的尺寸和形状,使得组件301的横截面积可沿其长度具有变化的尺寸和形状,以模拟骨(例如下颌骨)的自然变化轮廓。具体地讲,每个网状片材302的第一端部翼片316和第二端部翼片318可在尺寸和形状上变化,使得所得的移植物容纳结构304可在目标区域内建立所需的轮廓。
一旦每个网状片材302已经折叠并填充了移植材料,移植物容纳组件301可根据需要定位在骨的目标区域内,如图9和图10所示。由于网状片材302沿着第一纵向边缘334彼此连接,因此所形成的移植物容纳结构304可相对于彼此进行定位和/或取向(例如,成角度)以形成组件301的适于治疗目标区域的所需构型(例如,曲率)。移植物容纳组件可经由例如悬伸部328固定到骨的分离端部,该悬伸部328从网状片材中的第一网状片材302a延伸至网状片材中的最后一个网状片材302b,用以当组件301定位其中时延伸超出骨的分离端部。如图10所示,***300还可包括植入物,例如用于提供附加固定的骨板340。骨板340可横跨移植物容纳结构304延伸,使得其端部342、344沿着骨的分离部分的端部延伸。骨板340可以固定到每个移植物容纳结构304,以使相邻的移植物容纳结构304相对于彼此保持在所需位置/取向。
如图11所示,在另一个实施方案中,移植物容纳结构304可形成有凹槽346,该凹槽346的尺寸和形状被设定成在其中接纳骨板340,使得当骨板340被放置在移植物容纳结构304的凹槽346之内时,骨板340防止骨板340与骨移植物容纳结构304之间的相对运动,以及组件301的骨移植物容纳结构304之间的相对运动。在一个实施方案中,凹槽346可经由沿网状片材302延伸的其它折叠线306而形成。
本领域的技术人员应当理解的是,可在不脱离本发明实质或范围的情况下,对本发明的结构和方法作出多种修改和变型。因此,本发明旨在涵盖本发明的各种修改和变型,只要它们落入所附权利要求或其等效内容的范围内。
Claims (9)
1.一种骨移植物***,包括:
二维网状片材,所述二维网状片材的尺寸和形状被设定成当沿着折叠线折叠时,形成三维移植物容纳结构,所述三维移植物容纳结构被构造成填充有骨移植材料以放置在骨的目标区域内,所述网状片材包括:第一端部翼片,所述第一端部翼片经由第一折叠线连接到所述网状片材的剩余部分;以及第二端部翼片,所述第二端部翼片经由第二折叠线连接到所述网状片材的所述剩余部分,第三折叠线从所述第一折叠线延伸至所述第二折叠线,使得所述剩余部分被构造成包裹折叠好的第一端部翼片和第二端部翼片,以形成所述移植物容纳结构,所述第一端部翼片和所述第二端部翼片基本上对应于所述骨的所述目标区域的轮廓。
2.根据权利要求1所述的***,其中,所述网状片材包括重叠部分,所述重叠部分经由第四折叠线连接到所述网状片材的所述剩余部分。
3.根据权利要求1所述的***,其中,当所述网状片材被折叠以形成所述三维移植物容纳结构时,所述移植物容纳结构的第一端部和第二端部中的一个端部包括悬伸部,所述悬伸部延伸超过所述折叠的第一端部翼片和第二端部翼片中的一个翼片。
4.根据权利要求3所述的***,所述悬伸部被构造成延伸超出骨的一部分,以将所述移植物容纳结构固定到其上。
5.根据权利要求4所述的***,所述悬伸部包括延伸穿过其中的开口,所述开口的尺寸和形状被设定成用于接纳穿过其中的骨固定元件。
6.根据权利要求1所述的***,其中,所述网状片材经由延伸穿过其中的多个孔形成。
7.根据权利要求6所述的***,其中,所述网状片材经由多个相交撑条形成,所述相交撑条限定所述多个孔。
8.根据权利要求1所述的***,其中,所述网状片材的第一纵向边缘和第二纵向边缘沿曲线延伸并且包括相交的纵向折叠线和横向折叠线。
9.根据权利要求8所述的***,其中,所述横向折叠线的一部分包括沿其延伸的狭缝,使得在折叠时,所述骨移植物容纳结构沿着对应于患者下颌的曲率的曲线延伸。
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WO2018085526A2 (en) | 2018-05-11 |
US11633284B2 (en) | 2023-04-25 |
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US20210322171A1 (en) | 2021-10-21 |
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