CN109661208B - 装配关键支柱的颅骨成形手术板 - Google Patents
装配关键支柱的颅骨成形手术板 Download PDFInfo
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Abstract
本发明涉及一种在颅骨切除术后使用的可调节颅骨成形手术板。该组件包括附接到颅骨开口周围的颅骨上的环件和可调节地安装到环件上的板件。该板件可在位于环件上方的升高位置和基本上与环件齐平的降低位置之间移动。多个可伸展且可缩回的支杆在环件和板件之间延伸,以提供板件的可调节性。在环件和板件之间延伸的多个拉索在提升位置提供横向稳定性。该组件替代了原生骨骼,并且消除了进行后续颅骨修补术的需要。在一个实施例中,板件包括刚性中心部分,三个刚性安装突片和多个可延展的锥形周边瓣片,该锥形周边瓣片在板件和患者的颅骨之间提供平滑的界面。
Description
相关申请的交叉引用
本申请要求保护于2016年5月18日提交的临时申请美国序列号62/338,120的优先权,其通过引用整体并入本文。
背景技术
颅骨切除术是一种医学外科手术,通常用于处理常常由创伤或中风引起的难治性脑肿胀。当使用标准颅骨切除手术对患者进行处理时,需要进行两次手术。第一次进行颅骨切除术,其中去除一部分颅骨,然后在颅骨开口上闭合皮肤或头皮。颅骨切除术使脑组织通过开口扩张来降低颅内压。在脑肿胀消退(可能需要数周或数月)之后,需要进行第二次手术即颅骨修补术来放回保存的原生骨骼材料,或者另选地,植入假体颅骨片,诸如薄钛颅骨板件。该第二次手术在颅骨开口或缺损上方恢复固体覆盖物。
在颅骨切除术中移除颅骨部分允许脑组织扩张而不受颅骨的限制。没有颅骨保护,在肿胀在接下来的数周或数月内减少之前,大脑在皮肤下容易受到伤害,直到进行颅骨修补术修复颅骨缺损。在颅骨切除术和颅骨修补术之间的过渡期间,患者通常佩戴头盔以保护大脑。颅骨修补术增加了与患者护理相关的高成本。颅骨修补术程序还会增加患者风险,因为对大脑进行重大操作可能导致脑损伤,这可能导致颅内出血和癫痫发作,增加感染风险以及伤口破裂。此外,在颅骨修补术之前,患者经常患上头痛并且由于颅骨提供的正常颅内压梯度丧失而导致其恢复延迟。
发明内容
因此,本发明的主要目的是提供一种颅骨切除外科手术,其仅通过一次外科操作即可实现颅内压的减压和缓解并且为颅骨开口覆盖保护性固体。
本发明的另一个目的是提供一种在颅骨切除术后使用的改进的颅骨板组件。
本发明的又一个目的是提供一种颅骨板组件,其具有多个可调节支杆,以将板件定位在颅骨上方。
本发明的再一个目的是提供一种颅骨板组件,其可以在颅骨切除术操作期间植入,而不需要随后的颅骨修补操作。
本发明的另一个目的是提供一种外科手术,其中移除一部分颅骨以暴露大脑,并且将板件以和颅骨缺损适当的空间关系定位在颅骨上方,然后在脑肿胀消退之后,将板件降低到与颅骨相邻或齐平的位置,而不需要进行第二次外科手术。
本发明的再一个目的是提供一种颅骨成形手术板,其可调节地定位在患者颅骨上。
本发明的另一个目的是提供一种颅骨成形手术板,其可以相对于颅骨升高和降低。
本发明的再一个目的是提供一种颅骨成形手术板,其具有用于控制板件在颅骨开口上的位置的收缩构件。
本发明的又一个目的是提供一种颅骨成形手术板,其具有防止板件横向移位的器件。
本发明的再一个目的是提供一种颅骨成形手术板,其可以选择性地定位并且保持在颅骨开口上方。
本发明的另一个目的是提供一种在去除一部分颅骨后保护大脑的方法,其中环件固定到颅骨上,并且板件可调节地附接到环件上以容纳脑肿胀。
本发明的再一个目的是提供一种颅骨板,其具有到颅骨的三点固定部并且具有板件,该板件具有刚性中心部分,三个刚性安装延伸部和可延展的突片或瓣片。
本发明的另一个目的是提供一种颅骨板,当脑肿胀消退后,该颅骨板当处于降低位置时基本上与颅骨表面齐平。
本发明的又一个目的是提供一种改进的颅骨板组件,其制造经济,易于植入并且对患者安全。
通过以下描述,上述目的和其他目的会变得显而易见。
本发明的目的可以通过以下技术方案来实现:
本发明的颅骨成形手术板包括适于在颅骨切除术后围绕颅骨开口固定到颅骨的环件。使用多个在板件和环件之间径向向外延伸的支杆和拉索,将颅骨修补板件可调节地安装到环件上。支杆可在延伸位置和缩回位置之间移动,该延伸位置使板件相对于环件升高,而缩回位置使板件相对于环件降低。板件最初保持在颅骨上方的间隔距离处以保护大脑。支杆可枢转地附接到环件上并且可滑动地安装到板件上。支杆的位置可以经由棘轮或通过小型电动机调节。
颅骨成形手术板消除了脑肿胀消退后进行颅骨修补术的需要。在脑肿胀完全存在后,可以将板件降低到与颅骨相邻或齐平的位置,而不需要更换原生骨骼。
在优选实施例中,本发明的颅骨修补板件在三个等距点固定到颅骨上。该优选的颅骨板件具有刚性中心部分和三个用于附接到颅骨的刚性安装突片。在安装突片之间,在板件周边处是可延展的瓣片或突片,当板件处于初始升高位置时,瓣片或突片最初朝向颅骨向下弯曲或成角度,然后当板件处于降低位置时基本上平坦地水平延伸以便与颅骨齐平,从而在板件和颅骨表面之间提供平滑的界面。
附图说明
图1是根据本发明的颅骨板在升高位置的侧面立视图。
图2是处于降低位置的板的侧视图。
图3是示出了沿着图1中的线3-3截取的处于升高位置的枢转升降支杆、收缩结构和拉索的局部放大剖视图。
图4是沿图2中的线4-4截取的局部放大剖视图。
图5是沿图1中的线5-5截取的处于升高位置的组件的局部放大俯视平面图。
图6是沿图2中的线6-6截取的处于降低位置的组件的局部放大俯视平面图。
图7是组件的俯视平面图。
图8是组件的圆形棘轮的放大俯视平面图。
图9是沿图8中的线9-9截取的棘轮的剖视图。
图10是处于升高位置的支杆的另一个放大侧视图。
图11是处于升高位置的支杆的另一个放大侧视图。
图12是根据本发明的收缩通道、杆和缆线的局部剖视图。
图13是示出了具有开颅术的标准问号形创伤瓣的人的头部的侧面立视图。
图14是人的头部的侧面立视图,示出了根据本发明的用于颅骨板的模板件的放置。
图15是示出了在移除一部分颅骨之后颅骨中的开口的侧面立视图。
图16是根据本发明的颅骨成形手术板的优选实施例的俯视平面图,其中板组件固定在颅骨的3个点处,并且具有三个支杆,用于调节升高和降低之间的板组件位置。
图17A是图16中所示的板组件的一个边缘的侧面立视图,其中包括安装块和支杆块,支杆处于延伸位置,使得板组件处于升高位置。
图17B是类似于图17A的视图,其中在将板组件安装到颅骨之后移除了支杆块。
图17C是示出了图16的板件在脑肿胀停留后处于降低位置的另一个侧面立视图。
图18A是支杆块的侧面立视图。
图18B是支杆块的正面立视图。
图18C是沿图18B中的线C-C截取的支杆块的剖视图。
图19A是示出了图16中的板件处于升高位置并且可延展的凸缘瓣片向下朝向颅骨弯曲(并且为了清楚起见,移除了支杆)的侧面立视图。
图19B是示出了图16中的板件处于降低位置并且可延展的凸缘瓣片基本上与颅骨齐平的侧面立视图。
图20A是图16的板件的周边边缘的一部分的侧面立视图,其中板件处于升高位置并且可延展的凸缘瓣向下朝向颅骨弯曲。
图20B是示出了板件处于降低位置并且瓣片基本上与颅骨齐平的侧面立视图。
图21A是示出了图16的板件处于升高位置的另一个侧面立视图。
图21B是示出了图16的板件处于降低位置侧面立视图。
具体实施方式
本发明涉及一种颅骨板组件和在颅骨切除神经外科手术过程中手术安装该组件的方法。该板组件旨在取代在颅骨切除术期间移除的颅骨,并消除进行随后的颅骨修补术放回原生骨骼的需要。
本发明的颅骨板组件在附图中通常使用附图标记10表示。组件10包括板件12和环件14。环件14使用螺钉18固定到患者的颅骨16上。板件12通过围绕板件12等距间隔的支杆20附接到环件14上。虽然附图示出了使用间隔30°的十二个支杆20,但是应当理解,可以使用更多或更少的支杆,其中最少有三个间隔120°的支杆。
每个支杆20具有外端20,外端20通过销24枢转地连接到环件14。另选地,每个支杆20的外端22可以以任何其他方便的方式(包括一体成型铰链)枢转地固定到环件14上。
每个支杆20的内端26被卡在板件12中的通道28中。槽30沿通道28的底部延伸,使得内端26可以在通道内滑动。杆或圆柱32经由销34枢转地连接到支杆20的内端26。另选地,杆32和支杆20可以使用柔性铰链一体成型。杆32的内端附接到线或线缆36,线或线缆36又附接到安装在板件12中心处的棘轮或线轴38。支杆20、杆32、线缆36和棘轮38形成了收缩系统,由此棘轮38旋转会沿径向向内拉动或拖动线缆36和杆32,使得支杆20的内端26经由槽30沿通道28滑动。因此,在致动棘轮38时,板件12可从在颅骨16(图1、3和5)上方间隔开的升高位置移动到颅骨(图2,4和6)附近的降低位置。棘轮38包括头部40,当需要降低板件12时,头部40可以收容扳手或插座,以便沿图8中的顺时针运动方向转动棘轮38。轮38具有多个齿39和棘爪卡钩41,棘爪卡钩41用来啮合其中一个齿,并防止轮38反向旋转。
拉索42在板件12的周边和环件14之间延伸,以在处于升高位置时使板件12保持居中,其中线缆42处于张紧状态。当板件12移动到降低位置时,线缆42上的张力被移除,使得线缆42松弛(如图6所示)。
本发明的神经外科方法包括:第一步,使用在皮肤上切割的标准创伤瓣44暴露颅骨,如图16所示。模板46定位在颅骨开口48上方,使得外科医生或医务人员可以标记模板46的边界和固定螺钉18的位置50,如图14所示。模板边界限定了由外科医生进行的一次或多次后续骨骼切割。然后移除模板46。
接下来,外科医生进行开颅手术,沿着模板的标记线单独切割颅骨以移除一部分颅骨,使得颅骨开口48与模板尺寸和形状匹配。一旦打开硬脑膜,大脑就会以标准方式解压。人造硬脑膜可以放置在暴露的大脑的上方。
然后,外科医生将颅骨修补板10和环件12定位在颅骨开口48上,使得由环件12中的螺孔限定的固定点与固定位置标记50对齐。然后,外科医生将标准颅骨螺钉18穿过环件孔安装,以将颅骨修补环件12固定在固定点50处。围绕环件12的周边边缘的紧固件18的周向布置防止了环件的移位。支杆20和拉索42确保板10在颅骨16上方实现适当的初始定位。外科手术以安装帽状腱膜下引流管(未示出)和使用吻合器或缝线闭合皮瓣44而结束。
因此,颅骨板组件10包括可移动板件12和平稳固定环件14,收缩系统允许板件在颅骨表面上方约5mm的向上位置和颅骨开口48附近或内部的向下位置之间移动,以便与颅骨16基本齐平。支杆20防止板件12意外向下移动,而拉索42防止板件12从初始向上位置横向或向上偏移。因此,围绕组件10的圆周的支杆20和拉索42的组合始终保持组件的稳定性。收缩系统包括支杆20,杆或圆柱32,线缆36和板件12中的通道28,经由棘轮38相对于颅骨16控制并改变板件12的位置。板件12中的导向通道28还阻止了板件的意外弯曲或移动,例如,如果板件被撞击或以其他方式在无意中被接触。
优选地,棘轮38和头部40被皮瓣44覆盖。当脑肿胀减轻,并且是时候降低板件12时,可以在皮瓣44上开小切口以提供进入棘轮头部40的通路,从而允许棘轮38旋转以缩回线缆36和杆32,以便将连接的支杆20拉向板件12的中心,从而降低板件12。然后可以使用一根或多根缝合线或粘合剂闭合切口。
板组件10提供了经由收缩系统可调节地选择和设置板件12在颅骨上方的位置的能力。更具体地,支杆20与环件14和板件12之间的界面点被约束在导向通道28的背侧面上方。通过导向通道28的侧壁防止界面点的横向位移,同时通过导向通道28在杆或圆柱32的内端沿周向将其完全封闭的杆或圆柱32,防止界面点向下或沿腹侧位移。通过板件12上的周边唇缘52,并且因为收缩系统不能被拉伸,防止了朝向板件12的侧向或周边边缘位移。类似地,因为收缩系统不能被压缩,防止了朝向板件12的中心的位移。可以调节支杆20和收缩系统的界面位置的唯一方式是通过使用棘轮38卷收线缆36。
在优选实施例中,导向通道28形成在板件12内,但是另选地,可以附接在板件的底部或顶部上。
作为棘轮38的备选方案,小型电驱动电机可以安装在板件12上并附接到线缆36,并且使用遥控装置致动,这将消除进入棘轮头部40所需的微小手术切口。用来调节板件位置的其他致动器也在本发明的范围内。
因此,本发明的颅骨成形手术板10消除了这些患者通常所需的标准第二次颅骨修补外科手术。
在优选实施例中,组件10的所有部件均由刚性和轻质材料制成,诸如金属、塑料或复合材料。板件12和/或环件12可以包括孔或开口,以使重量最小化,而不会牺牲强度和耐用性。此外,其他类型的线性致动器可以代替收缩系统来升高和降低板件12。
颅骨成形手术板的优选实施例如图16-21所示。该优选组件10A包括具有三个支杆20A和中心棘轮38A的板件12A,其如上文关于颅骨成形手术板10所述起作用。上述环件14由3个单独的安装块54替代,安装块54使用螺钉18固定到与颅骨开口附近的颅骨上。板10A具有刚性中心部分56和三个刚性安装突片或延伸部58,支杆20A延伸到该刚性安装突片或延伸部58。板件12A的周边边缘在安装凸片56之间具有可延展的凸缘瓣片或凸片58,如图16所示。瓣片58逐渐变细到其外边缘的相对较薄的厚度。
当将颅骨成形手术板10A安装在患者颅骨下方时,使用螺钉18将安装块54附接到在所需位置处的颅骨16上。如图17A所示,支杆块60将支杆20A固持在倾斜位置,使板件12A在颅骨48上方间隔开。在安装组件10A之后,移除支杆块54,并且板件保持在升高位置,如图17B所示。在颅骨肿胀消退之后,可以将板件降低到与颅骨16基本齐平的位置,如图17C所示,致动棘轮38A使得杆32A和线缆32A、36A将板件12A缩回并降低,类似于上面关于板组件10描述的过程。
可延展瓣片或突片58最初朝向颅骨16延伸或向下弯曲,如图19A、20A和21A所示。当降低板件12A时,可延展瓣片58基本上与颅骨16齐平并在颅骨和板件之间提供平滑界面,如图19B、20B和21B所示。
当板组件10、10A处于降低或下降位置时,板件12、12A应当与患者的颅骨稳固接合,而不会在向患者的表层头皮施力时出现摇动或运动。对于现有技术中的常规颅骨修补板件,这种固定是通过具有与患者颅骨的轮廓良好贴合的轮廓的板件实现的,通过在植入板件的圆周周围放置许多骨钉来实现稳定性。骨钉还确保了植入物边缘和患者颅骨之间的界面基本上齐平,以便最大限度地减小头皮皮肤在任何凸起的板件边缘上发生破裂的风险。然而,放置多个螺钉的要求延长了外科手术的持续时间并且增加了外科医生在操作期间的工作负荷。
另外,由于颅骨板件通常在紧急或应急外科手术过程中放置,因此必须使用现成的板件植入物,因为没有足够的时间来制造定制的贴合板件。不可避免地,这些现成的植入物的轮廓与患者颅骨的轮廓不能精确匹配。图16-图21中所示的三点固定颅骨板组件10A经过可延展的锥形瓣片58克服了这个现有技术问题,锥形瓣片58提供了与颅骨表面的平滑界面,同时还允许通过提供到棘轮38A的入路的单一小切口降低板件12A。当板件12A处于降低位置时,三个等距刚性延伸部或突片56经由缩回的支杆20A固定在颅骨16上的适当位置。即使在患者的颅骨和组件10A之间存在表面轮廓差异时,瓣片58的锥形边缘也可确保板件和颅骨平面之间平滑的周向界面。相邻凸缘瓣片上的位置差异将是最小的,并且当头皮重新定位在组件10A顶部上时不可察觉。
支杆块60可以由塑料或其他半延展性材料构成。每个支杆块60包括槽62,槽62可以在刚性安装凸片57(如图17A所示)和支杆20A上滑动,使得支杆被收容在支杆块60的导向通道64中。在安装组件10A之后,可以使用标准手术技术在植入物10A上闭合头皮。
如针对板组件10所描述的,外科医生使用模板来描绘将要创建的颅骨开口48的轮廓线,并选择尺寸合适的植入板组件。与标准的颅骨切除手术相比,描绘颅骨开口和位置以及固定组件10A所需的时间需要额外的手术时间。额外的时间通常不到5分钟。
在脑肿胀消散后(手术后大约两周),使用组件10中描述的相同的棘轮技术将板件12A移动到向下位置。这可以在门诊诊所进行。将注射局部麻醉并在中心圆形棘轮外壳上方开小切口(小于1cm)。外科医生将使用手持式棘轮旋转器(例如六角扳手)旋转棘轮38A并将三个收缩构造32A、36A拉向中心,从而向下拉动板件12A直至其与颅骨16齐平。在操作期间,外科医生将用对侧的手在板件12A上轻轻地手动施加向下的压力。一旦将板件12A固定在向下位置,即可将切口缝合闭合。整个手术时间估计不到10分钟。
组件10A相对于组件10具有多个优点,包括:(1)改善了最终向下位置的位置稳定性;(2)由于连接点更少,简化了手术植入技术而且速度更快(将组件固定到颅骨上的时间大约减少了80%,并且标准颅骨切除外科手术增加的时间不到5分钟);(3)由于零件更少,简化了制造,降低了成本。
上面已经通过优选实施例示出和描述了本发明,并且应当理解,可以进行的许多修改、替换和添加均落入本发明的预期精神和范围之内。从上述内容可以看出,本发明至少实现了其列出的所有目的。
Claims (9)
1.一种颅骨成形手术板,其特征在于,包括:
板件,覆盖颅骨开口并且具有相对的上表面和下表面以及周边边缘;
环件,其适于固定到颅骨上;
多个支杆,每个支杆具有相对的内端和外端,所述内端和外端附接到所述板件和所述环件,以便在用来将所述板件保持在所述颅骨上方间隔距离处的升高位置和用于将所述板件定位在所述颅骨附近的降低位置之间移动;
还包括收缩系统,其用来使所述内端沿径向向内朝向所述板件的中心移动;
所述收缩系统包括多根连接到所述支杆的所述内端的线和用于缠绕所述线的线轴。
2.如权利要求1所述的颅骨成形手术板,其特征在于,所述支杆的所述外端可枢转地附接到所述环件上。
3.如权利要求1所述的颅骨成形手术板,其特征在于,所述支杆的所述内端可滑动地安装到所述板件上。
4.如权利要求1所述的颅骨成形手术板,其特征在于,所述线轴为棘轮式。
5.如权利要求1所述的颅骨成形手术板,其特征在于,所述线轴包括具有多个齿的棘爪,以及用于接合其中一个所述齿的卡钩。
6.一种用于开颅后形成颅骨开口的可调节板组件,其特征在于,包括:
环件,其适于附接到所述颅骨上,以便围绕所述开口延伸;
板件,其可调节地安装到所述环件上,并且能够在所述环件上方间隔开的升高位置和与所述环件基本齐平的降低位置之间移动;
还包括多个可延伸并且可缩回的支杆,所述支杆在所述板件和所述环件之间延伸,以相对于所述环件将所述板件定位在选定位置;
每个支杆具有可枢转地连接到所述环件上的外端和可滑动地安装到所述板件上的内端;
每个支杆的所述内端附接到缆线上,并且所述缆线连接到轮,所述轮旋转以缩回所述缆线和所述支杆。
7.如权利要求6所述的可调节板组件,其特征在于,所述轮包括齿和卡钩,所述卡钩用来啮合所述齿以防所述轮反向旋转。
8.如权利要求6所述的可调节板组件,其特征在于,还包括致动器,所述致动器连接到所述支杆,以使所述支杆在所述升高位置和所述降低位置之间移动。
9.如权利要求6所述的可调节板组件,其特征在于,还包括多根电缆,所述电缆在所述板件和所述环件之间延伸,以防当所述板件处于所述升高位置时所述板件相对于所述环件横向移动。
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- 2017-05-18 BR BR112018073648-1A patent/BR112018073648A2/pt not_active Application Discontinuation
- 2017-05-18 US US16/301,655 patent/US10893896B2/en active Active
- 2017-05-18 AU AU2017268377A patent/AU2017268377A1/en not_active Abandoned
- 2017-05-18 JP JP2018560483A patent/JP2019516481A/ja active Pending
- 2017-05-18 RU RU2018144185A patent/RU2738853C2/ru active
- 2017-05-18 WO PCT/US2017/033274 patent/WO2017201253A1/en unknown
- 2017-05-18 CN CN201780030121.2A patent/CN109661208B/zh active Active
- 2017-05-18 CA CA3024581A patent/CA3024581A1/en not_active Abandoned
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RU2738853C2 (ru) | 2020-12-17 |
CN109661208A (zh) | 2019-04-19 |
US20190282282A1 (en) | 2019-09-19 |
RU2018144185A3 (zh) | 2020-09-04 |
WO2017201253A1 (en) | 2017-11-23 |
RU2018144185A (ru) | 2020-06-18 |
BR112018073648A2 (pt) | 2019-02-19 |
EP3457965A4 (en) | 2020-07-29 |
EP3457965A1 (en) | 2019-03-27 |
AU2017268377A1 (en) | 2018-12-13 |
JP2019516481A (ja) | 2019-06-20 |
US10893896B2 (en) | 2021-01-19 |
CA3024581A1 (en) | 2017-11-23 |
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