CN208096810U - 外科手术套件和用于覆盖脊柱的一部分的护罩 - Google Patents
外科手术套件和用于覆盖脊柱的一部分的护罩 Download PDFInfo
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- CN208096810U CN208096810U CN201720534239.6U CN201720534239U CN208096810U CN 208096810 U CN208096810 U CN 208096810U CN 201720534239 U CN201720534239 U CN 201720534239U CN 208096810 U CN208096810 U CN 208096810U
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Abstract
外科手术套件和用于覆盖脊柱的一部分的护罩。外科手术套件包括用于覆盖受试者脊柱的一部分的护罩。所述护罩可包括适于接合骨固定组件的附接部分,所述骨固定组件适于被固定在所述受试者的多个椎骨上。所述骨固定组件可包括固定在两个骨锚之间的脊椎联结构件。每个骨锚可包括适于被植入椎骨中的紧固件部分和适于固定所述脊椎联结构件的头部联接部分。所述护罩可通过固定在所述骨固定组件的脊椎联结构件之间的单独联接元件(诸如夹具或可调节链环)联接到所述骨固定组件。可替代地,所述护罩可包括被构造成直接接合所述骨固定组件的整体附接部分。
Description
优先权
本申请要求美国临时申请号62/364,621(2016年7月20日提交) 的权益。
在本说明书中引用的参考文献及其参考文献通过引用的方式整体并入本文中,其适合于教导另外的或可替代的细节、特征和/或背景。
技术领域
本实用新型涉及脊柱植入物。更具体地,本实用新型涉及用于在椎板切除术之后保护人的脊柱的脊柱装置。
背景技术
椎板切除术是一种将称为锥板的椎骨部分(覆盖人脊柱管的椎骨的后面部分)移除的外科手术。又称减压术,椎板切除术放大脊柱管来减轻脊髓或神经上的压力(所述压力最常见地由骨在脊柱管内生长过度引起,这可发生在那些脊柱中具有关节炎的人中)。
这些是世界范围中执行的椎板切除术的若干不幸结果,这些不幸结果尚未解决。首先,椎板切除术移除了脊柱的后路保护元件。因此,患者仅留下封闭的脊旁肌、筋膜、皮下、组织和皮肤缝合。尽管椎板不被认为是脊柱必要的支持性部分,但是椎板的损失理论上导致在手术区域中对神经组织带来直接损伤的可能性。在腰部脊柱中,经常存在来自肌肉和筋膜的足够保护;然而,在颈部脊柱中,脊旁肌肉组织受到限制。第二,瘢痕组织在椎板切除术之后出现(set-in),因为在硬脑膜上封闭的脊旁肌在其上形成纤维层。在硬脑膜和神经根周围的瘢痕组织可压迫神经根和马尾,从而产生神经并发症,诸如持续性腰痛、坐骨神经痛和/或肠和膀胱功能障碍。第三,由于复发性椎间盘突出、术后脊柱狭窄(医源性的或获得性的)或因为高度增生的硬膜外纤维化,翻修手术可证明是必要的。因此,在没有正常界标和原有椎板的保护的帮助下,重复的暴露需要仔细检查先前的手术部位。在这种情况下,外科医生使硬脑膜损伤的可能性更大,从而导致脑脊髓液(CSF) 渗漏。外观上,当伤口收缩时,给患者留下经常在手术部位上可见的明显的挛缩凹痕或凹腔。这种“凹痕”经常在外观上,具体地在偏瘦患者中,尤其在颈椎或胸椎上是不令人希望的。
美国专利号6,454,767公开了一种用于减少术后粘连形成的脊柱保护装置或套件。所述装置包括适于覆盖脊椎动物脊柱的骨解剖体的有孔护罩。所述护罩可包括伸长的空腔并且可包括接近于护罩边缘以接受附接销的附接端口,以及用于将护罩附接到骨的多个附接销。图 1A是根据美国专利号6,454,767的第五腰椎的椎板切除术的图解。脊髓24由单个腰椎26组成的椎柱和椎板40围绕,每个腰椎26由横突 30和棘突32组成。脊椎中的一个已经经受椎板切除术(切割横截面以阴影线示出)。图1B是安装在腰椎上的护罩10的图解,其中护罩10 定位在椎板切除部位上。附接平板18附接到棘突,并且一组四个附接销20用来在适当位置处将护罩10的四个角锚定到周围脊椎组织。
需要具有以下令人希望的特性的改进的脊柱保护装置:
1)在椎板切除术之后对脊髓或相关联的神经根提供保护。
2)防止由于硬脑膜顶部的治愈成纤维细胞而造成术后瘢痕形成。
3)提供容易的界标使得外科医生在暴露以再次进行外科手术期间不能进入硬脑膜并且引起CSF渗漏。
4)在椎板切除术之后防止外观缺陷。
5)在椎板切除术或脊柱后路融合术之后易于施用,尤其对于患有融合的患者。
6)提供长期的耐久性并且促进重复进行脊柱外科手术。
实用新型内容
在一个方面中,本实用新型提供外科手术套件。所述套件可包括用于覆盖受试者脊柱的一部分的护罩。所述护罩可包括适于接合骨固定组件的附接部分,所述骨固定组件适于被固定在受试者的多个椎骨上。
在一个实施方案中,骨固定组件包括固定在两个骨锚之间的至少一个脊椎联结构件,每个骨锚包括适于植入椎骨中的紧固件部分和适于固定脊椎联结构件的头部联接部分。
在另一个实施方案中,护罩的附接部分适于接合骨固定组件的脊椎联结构件。在替代性实施方案中,护罩的附接部分适于接合骨固定组件的骨锚中的至少一个。
可替代地,护罩的附接部分包括用于接合骨固定组件的脊椎联结构件的钩件部分。骨固定组件可包括由脊椎联结构件连接的一个骨螺钉或多于一个骨螺钉。脊椎联结构件可以是可具有可伸缩构型的杆。
在一些实施方案中,护罩具有可调节横向宽度。在一个实施方案中,护罩包括各自包含用于接合骨固定组件的脊椎联结构件的一个钩件的两个零件,其中所述两个零件彼此适于在多个侧向位置处接合。在一个实施方案中,存在两个钩件,所述两个钩件被构造成可移除地附接到杆,并且连接构件设置在所述两个钩件之间。
所述连接构件可包括可滑动地在中心螺钉处联结的两个连接构件。
所述护罩可具有垂直长度以覆盖至少两个或更多个脊椎。所述护罩还可包括多个护罩,其中相邻护罩以连续的方式一个堆叠在另一个的顶部。
所述护罩可包括在外科手术套件中,所述外科手术套件包括适于将护罩的附接部分固定到骨锚中的一个的至少一个联接元件。所述外科手术套件还可包括适于将护罩的附接部分固定到脊椎联结构件的至少一个联接元件。在这些实施方案中,联接元件可以是具有开口端的夹具。在一个实施方案中,所述夹具可具有奥米伽类型的形状。联接元件可以可移除地附接到骨螺钉。在一些实施方案中,附接部分包括联接元件,所述联接元件包括两个侧钩件和连接构件。
在又一个实施方案中,骨固定组件包括各自固定在两个骨锚之间的至少两个脊椎联结构件。所述外科手术套件还包括适于接合所述两个脊椎联结构件中的每一个的链环(link)。所述链环可包括固定元件以将护罩固定在其上。在一个实施方案中,链环可包括彼此处于可滑动构型的两个连接构件以便允许调节链环在脊椎上的横向长度。在一个实施方案中,所述护罩包括各自附连到链环的所述两个连接构件的相应构件的两个零件,并且当链环的两个连接构件相对于彼此移动时,可调节在所述两个零件之间的侧向距离。
护罩的附接部分可包括至少一个孔。所述护罩可包括伸长的凹面。所述附接部分可包括在护罩的相对侧上侧向延伸的两个零件。
在一个实施方案中,所述护罩包括两个侧向零件,每个侧向零件包括护罩部分和钩件部分,所述护罩通过附接部分固定到骨固定组件,并且所述附接部分被构造成可移除地附接到骨固定组件。
在一个实施方案中,所述护罩包括两个半圆顶,其中每个半圆顶固定到一个连接构件。
所述护罩可包括聚合物材料(诸如PEEK)或由其制成。在其他实施方案中,所述护罩可包括金属或金属合金材料,诸如钛或其合金。
所述护罩还可包括至少一种治疗剂,诸如抗狭窄剂、抗纤维化剂或抗生素剂。
附图说明
图1A(现有技术)是示出与椎板切除术相关联的身体解剖体的腰椎的部分透视图。
图1B(现有技术)是示出使用现有技术护罩来覆盖图1A中示出的椎板切除术解剖体的部分透视图。
图2A是本实用新型的实施方案的脊柱保护护罩的透视图;图2B 是图2A中示出的脊柱保护护罩的顶视图;图2C是本实用新型的另一个实施方案的脊柱保护护罩的顶视图;图2D和图2E是根据本实用新型的实施方案的具有不同附接部分的脊柱保护护罩的顶视图。
图3描绘当被植入在已经执行椎板切除术的受试者脊柱的一部分的椎骨上时的骨固定组件。
图4描绘骨固定组件的锚的示例性内部结构。
图5描绘根据本实用新型的某些实施方案的通过骨固定组件安装在椎板切除部位上的脊柱保护护罩。
图6A-6M描绘根据本实用新型的实施方案的用于将脊柱保护护罩固定到骨固定组件的脊椎联结构件的联接元件的各种构型。
图7A和图7B描绘根据本实用新型的实施方案的将脊柱保护护罩与骨固定组件的锚联接。
图8A-8I描绘根据本实用新型的实施方案的脊柱保护护罩的附接部分的各种构型,所述附接部分包括用于接合骨固定组件的一部分的结构特征部。
图9A和图9B描绘本实用新型的实施方案。
图10A和图10B描绘本实用新型的附接到椎柱的机构。
具体实施方式
本实用新型总体涉及外科手术套件,所述外科手术套件包括适于例如在椎板切除术之后或在脊柱后路融合术之后覆盖受试者脊柱的一部分的护罩。所述护罩包括适于接合骨固定组件的附接部分,所述骨固定组件适于被固定在受试者的多个椎骨上。所述附接部分可以可移除地附接到骨固定组件。
在图2A和图2B中示出护罩的实例。护罩100可包括主体部分 100,所述主体部分100可采用弓形形状110(例如,弯曲形状、椭圆形或梯形)或具有伸长的凹面;以及附接部分120a和120b,所述附接部分120a和120b可包括孔或开口122a和122b以容纳附接销或其他联接机构以便将护罩固定到骨(例如,脊椎)上。所述孔可假定是圆形、椭圆形、正方形或其他形状。尽管附接部分120a和120b被示出各自包括两个孔;但是可包括更少或更多的孔以为固定提供替代性选择 (在图2C中示出在各个附接部分上仅具有一个孔的护罩的实例),例如,3个、4个、5个、6个、7个、8个、9个、10个……n个。护罩100可相对于轴线101对称,其中附接部分在相对侧上相对于轴线 101侧向延伸。在使用中,轴线101可在垂直、轴向路径上与脊柱对准。护罩100沿轴线(或垂直长度)具有可被构造成如所希望或按需覆盖脊柱(spine或spinal column)的不同区段(例如,颈部、胸部、腰部等)的一个脊椎或两个或更多个连续脊椎(例如,3个、4个、5个、6 个、7个、8个、9个、10个脊椎)的长度L。护罩100具有总宽度W 并且护罩的主体具有宽度W1,其中的两者都可被选择或调制以适合护罩在植入护罩的脊柱上的位置。如下文所示,在某些实施方案中,宽度W和/或W1可以是可调节的。
可替代地,附接部分可不具有孔,但是作为替代可包括帮助将护罩固定到骨固定组件的其他结构特征部。用于将护罩固定到骨固定组件的手段在下文进一步描述。在护罩100的任一侧面上也可具有多个附接部分,并且所述附接部分可采用各种形状和大小,如在图2D (120a、120b、120a’、120b’)和图2E(120c、120d)中所示。
如本文所述,保护护罩被构造成接合骨固定组件,所述骨固定组件可以是外科手术套件的一部分或单独地被提供。在一个实施方案中,并且如图3所示,骨固定组件200可包括固定在两骨锚231a与 232a之间的脊椎联结构件220a,和固定在两骨锚231b与232b之间的脊椎联结构件220b。可将所述骨锚植入相应脊椎26a和26b的横突27a和27b的一部分中。在锚231a-232a之间和在锚231b-232b之间的脊椎联结构件220a/220b帮助抑制两个脊椎26a与26b之间的相对运动。虽然示出为圆柱形,但是脊椎联结构件220a/220b可具有任何希望的横截面形状,诸如椭圆形、矩形或其他多边形状。还在图3 中示出了经切割的椎板42(已经将棘突和一部分椎板移除),脊髓24 的一部分从该经切割的椎板42被暴露。本实用新型的护罩(其在使用时)可覆盖(而无需接触)这部分被暴露的脊髓24并且可附接到骨固定组件200。对于不具有脊柱融合的简单的椎板切除术,图2中示出的保护护罩100还可使用通过孔122a和/或122b插入的皮质骨螺钉简单地固定到剩余骨(或残留椎板)或中间面关节上。
图3中示出的骨固定组件可采用多种构型。例如,图4描绘图3 中示出的骨固定组件的实施方案的说明性横截面图。锚210a包括紧固件部分250,所述紧固件部分250可以是具有头部部分251和螺纹部分252以用于促进其植入椎骨(例如,图3中所示的脊椎26a的横突部分)中的骨螺钉。紧固件部分250包括用来例如通过螺丝刀或其他机械装置来驱动螺纹部分进入骨中的接收座254。锚210a还包括头部联接部分260,所述头部联接部分260包括外壳262和锁定构件264,所述锁定构件264可被构造成用配对螺纹与外壳262的内部表面263接合,并且将脊椎联结构件220a通过摩擦锁定在一定位置中。在一个实施方案中,骨固定组件包括由脊椎联结构件连接的两骨螺钉。脊椎联结构件可以可移除地附接到所述一个或多个骨螺钉。
在图3和图4中所示的实施方案中,当锁定构件264处于未锁定位置时(例如,当它不接触脊椎联结构件220a时),脊椎联结构件220a 可沿其长度方向移动,从而调节设置在两个锚231a与232a之间(并且在所述两个锚231b与232b之间)的脊椎联结构件220a的长度。脊椎联结构件可以是杆。可替代地,脊椎联结构件可沿其长轴具有可伸缩构型;在已经将脊椎联结构件220a的两端锁定到相应锚上之后,这种可伸缩构型允许调节设置在两个锚231a与232a之间的脊椎联结构件220a的长度。
另外,锚210a可包括通过双球窝关节构型连接头部联接部分260 和紧固件部分250的链环270,所述双球窝关节构型允许头部联接部分260相对于紧固件部分250的轴线旋转和/或枢转。通路272被限定在链环270内,所述通路272与紧固件部分250的接收座254对准以允许拉紧工具(例如,螺丝刀)通过头部联接部分260(在安装脊椎联结构件220a之前)直接接触接收座254以将紧固件部分250固定到骨中。
本实用新型的护罩可以各种方式接合骨固定组件。例如,护罩的附接部分可由如图4所示的紧固件部分250例如通过穿过附接部分的孔插入螺纹部分252来固定到椎骨,从而允许头部部分251将护罩的附接部分120a或120b固定到椎骨上。
在优选实施方案中,在植入骨固定组件之后将护罩固定到骨固定组件上。如图5所示,护罩100可通过附接部分120a/120b固定到已经被安装在骨上的骨固定组件的杆。这种方法允许容易且快速安装以及更换护罩,同时将固定组件保持在适当位置。
为了促进将护罩固定到骨固定组件上,保护护罩可包括被定形并且被构造成(例如,在杆上或在骨锚上)直接接合骨固定组件的附接部分。可替代地,外科手术套件可包括一个或多个联接元件以将护罩的附接部分联接到骨固定组件,例如,联接到脊椎联结构件和/或联接到骨固定组件200的头部联接部分。优选地,联接元件在脊椎联结构件220上固定在处于与脊椎联结构件关联的两个骨锚之间的一定位置处。
如图6A所示,用来固定脊椎联结构件的附接的联接元件可采用夹具310的形式。夹具可被构造有适当的弹性和伸直长度以卷绕骨固定组件的脊椎联结构件圆周的至少一部分,以便抵靠脊椎联结构件 220固定所述附接部分。图6B示出护罩100通过穿过护罩100的附接部分的孔122b插入夹具310并且卷绕脊椎联结构件220的圆周来固定到脊椎联结构件220。
如图6C所示,联接元件还可采用具有开口端或奥米伽(“Ω”)形状的夹具320的形式,所述夹具320包括具有开口宽度Wb的球状部分 322、具有开口宽度Wn(Wn<Wb)的颈部部分324,以及扩口端部分 326。图6D示出护罩100通过经由护罩100的附接部分的孔122插入夹具320并且将所述夹具320卷绕脊椎联结构件220的圆周来固定到脊椎联结构件220。优选地,奥米伽(“Ω”)形状定形的夹具320的大小、构型和弹性是使得球状部分322可卷绕脊椎联结构件220的圆周至少多于180°,并且使得当夹具320固定到脊椎联结构件220上时,颈部部分324的宽度Wn小于脊椎联结构件220的直径。奥米伽(“Ω”) 形状构型的优点包括容易部署夹具320。操作员可朝向脊椎联结构件 220推动开口端,并且所述开口端将归因于夹具320的弹性而扩张,从而允许球状部分322借助于颈部部分324卡扣配合到脊椎联结构件220的圆周上,以便将脊椎联结构件220通过摩擦锁定到一定位置中。
如图6E中所示,联接元件也可采用在夹具端部附近具有锁定机构的夹具330的形式。夹具330包括伸长机构332、在伸长机构332 的一端附近的突出部分336以及在伸长机构332的另一端附近的端口 334。突出部分336被构造有适当尺寸以被插入部分334中来形成封闭结构,其中突出部336摩擦地接合端口334。如若需要,所述封闭结构可被手动地重新打开,但是另外具有足够的稳定性来植入身体中以供长期使用。伸长构件332的在突出部分336与端口334之间的伸直长度可被调制成足以卷绕脊椎联结构件的圆周以允许将突出部分 336插入端口334中。图6F示出护罩100通过穿过护罩100的附接部分的孔122b插入夹具330的伸长构件332并且将所述伸长构件332 卷绕脊椎联结构件220的圆周来固定到脊椎联结构件220,并且突出部分336锁定在端口334以形成封闭结构以便将所述护罩固定到脊椎联结构件220。
在另一个实施方案中,如图6G和图6H所示,联接元件可采用链环340的形式,所述链环340被构造成横向地跨过脊椎以接合骨固定组件的安装在脊柱两侧上的脊椎联结构件(杆)(参见图3)。链环340 包括侧向或侧钩件348a和348b,所述侧向或侧钩件348a和348b被设定尺寸并且被构造成接合脊椎联结构件(杆)。每个钩件还配备有螺钉344a/344b以用于拉紧相应杆。连接构件346b自钩件348b延伸。连接构件346b的远端包括用于接收中心螺钉342的放大部分345,以及用于可滑动地接收自钩件348a/348b延伸的连接构件346a的箍结构343。在钩件348a与348b之间的横向长度LL可凭借两个连接构件346a与346b之间的可滑动连接进行调节。连接构件346a可在箍 343内旋转,并且所述两个连接构件346a和346b也可从线性排列偏离(例如,它们可形成角度),从而容许链环340与骨固定组件的可能不是平行构型的脊椎联结构件联接。在操作中,当获得链环340的构型的所需长度LL和其他可调节参数时(例如,当获得钩件与脊椎联结构件之间的拉紧配合时),中心螺钉342可被拉紧来接合连接构件 346a,从而固定长度LL。螺钉344a和344b可被拉紧,使得它们固定地接合骨固定组件的脊椎联结构件(杆)。图6H示出固定到骨固定组件的脊椎联结构件220a/220b上时的联接元件340。
本实用新型的护罩可以各种方式固定。例如,如图6I中示意性地示出,护罩100可具有沿其长轴线或垂直轴线(例如,沿护罩100 的纵向轴线101)定位的多个孔口125a、125b和125c,其中所述孔口的大小被适配成使得链环340的螺钉342可通过所述孔口而被插入以便将护罩100固定到其上。如图6J(组装在三个链环上的护罩100的自顶向下视图)所示,护罩100通过链环的中心螺钉342a、342b和342c 固定到三个链环340a、340b和340c(所述三个链环340a、340b和340c 由其相应侧钩件固定到相应杆220a和220b)。因此,当中心螺钉342a、 342b和342c被拉紧时,链环340a、340b和340c的侧向跨度被固定,并且同时护罩100被固定到脊椎。
图6K和图6L示出如先前结合图6G和图6H所述联接元件采用链环340的形式的替代性实例。在这个实施方案中,护罩100可包括两个零件100a和100b,所述两个零件100a和100b假定为分别具有经切割的顶部100a1和100b1的半圆顶或弯曲壳体的构型。零件100a和100b可分别固定到链环340的连接构件346a和346b上。所述固定可由机械联接、化学粘结、物理粘结等完成。在护罩两个零件100a 和100b之间的侧向距离可通过相对于连接构件346b滑动连接构件 346a来调节。例如,当两个侧向钩件348a和348b处于第一开口构型中(如图6K所示)时,在护罩的两个零件100a和100b之间存在侧向间隙Dg。在两个连接构件346a和346b抵靠彼此滑动使得所述两个侧向钩件348a和348b处于第二更加紧凑的构型中(如图6L)之后,所述两个零件100a和100b在中心接缝100s相遇或在中间至少部分地重叠,使得在所述两个零件100a和100b之间不再存在侧向间隙。在这种构型中,护罩100的上部部分可模拟棘突的形状。这种构型还可用作用于植入的最终组装的构型,其中连接构件346a和346b可通过由拉紧工具(例如,螺丝刀)拉紧螺钉342来彼此锁定,所述拉紧工具可通过在此构型处由两个零件100a和100b形成的顶部开口100h进入螺钉342。
在联接元件用来将所述护罩联接到脊椎联结构件上的上述实施方案中,为了提高联接元件与脊椎联结构件之间的摩擦,所述脊椎联结构件可包括槽、凹窝、凹痕或其他表面不规则物。
在另一个实施方案中,如图6M所示,联接元件可采用链环350 的形式,所述链环350被构造成横向地跨过脊柱以接合骨固定组件的安装在脊柱两侧上的脊椎联结构件(杆)。链环350包括被设定尺寸并且被构造成接合脊椎联结构件(杆)的侧向或侧钩件358a和358b。所述钩件具有可呈“Ω”(奥米伽)形状的开口端。连接构件356b从钩件 358b延伸;连接构件356a从钩件358a延伸。连接构件356b的远端包括用于接收附接到连接构件356a的螺栓352的伸长端口355;所述螺栓向上延伸通过端口355以可滑动地连接连接构件356a和356b。由于在连接构件356a与356b之间的可滑动连接,在钩件358a与358b 之间的横向长度LL是可调节的。连接构件356a和356b可相对于彼此旋转以形成非线性排列。例如,连接构件可移动以在它们之间形成小于180°的角度。螺栓352可被拉紧以使连接构件356a与连接构件 356b接合,从而固定长度LL。
在其他实施方案中,联接元件可被构造用于将护罩100的附接部分与骨固定组件的骨锚直接联接。作为另一个实例,这些夹具可用来联接到如图4所示的头部联接部分260。也可使用其他形式的联接元件。例如,图7A和7B示出附接销(或大头钉/螺钉)380,所述附接销 380具有头部部分382;接合部分384,所述接合部分384被设定尺寸并且被构造成通过护罩的附接部分120a、120b的孔122a/122b插入头部联接部分260(参见图4)的锁定构件264的槽座265中,从而将护罩的附接部分120a、120b固定到头部联接部分260。
在另一个实施方案中,本实用新型的护罩的附接部分可包括被构造成接合骨固定组件的整体部分。例如,如图6A、6C和6F所示的各种联接元件(夹具)制造为护罩100的附接部分,或与护罩100的附接部分集成一体。如在图8A所示,奥米伽(“Ω”)形状定形的夹具420可独立于护罩100制造并且然后与护罩100的附接部分120集成一体或联结(例如,通过焊接、粘附或本领域中通常已知的技术)。图8B 示出具有附接部分120的护罩100,所述附接部分120包括奥米伽(“Ω”) 形状定形的端部部分430。夹具420或奥米伽(“Ω”)形状定形的端部部分430可用于接合脊椎联结构件220或与脊椎联结构件220关联的骨锚。虽然夹具420或奥米伽(“Ω”)形状定形的端部部分430的开口端在图8A和图8B中示出为朝向脊椎联结构件220侧向定向,但是也涵盖其他定向,例如,向下或斜向下。
本实用新型的护罩的附接部分也可包括被构造成接合骨固定组件的除脊椎联结构件之外的零件的其他整体结构元件。例如,如图 8C所示,护罩100的附接部分120包括突出部分440,所述突出部分 440(诸如图7A和图7B中的附接销380)被设定尺寸并且被构造成插入头部联接部分260的锁定构件264的槽座265中,从而将护罩100 的附接部分120固定到头部联接部分260上。
图8D示出护罩100的被构造为钩件以在两侧边上接合脊椎联结构件220a和220b的附接部分120a和120b的另一个实例。在本实施方案中,护罩100、附接部分120a/120b由联结在一起的两个工件形成。图8E示出图8D中所示的结构的变体,其中可紧固接近于钩件定位的附接销180a和180b(例如,螺钉)以接触脊椎联结构件(杆)220a 和220b,从而为钩件与脊椎联结构件(杆)220a和220b之间的接合提供进一步的安全性。
图8F-H示出护罩100的被构造为钩件的附接部分120a和120b 的另一个实例,其中护罩100具有可调节横向宽度或侧向宽度。在本实施方案中,护罩100包括两个侧向零件(或半部)100a和100b,每个侧向零件包括沿宽度方向定向的狭缝102a和102b。为了在外科手术期间组装护罩,操作员可首先将所述两个相应钩件与骨固定组件(未示出)的脊椎联结构件接合,并且朝向彼此滑动护罩的所述两个半部直到达到希望的位置,所述希望的位置为在狭缝102a/102b对准的情况下,所述两个半部部分地与彼此重叠。然后,操作员可使用附接销181穿过狭缝102a和102b的开口将护罩固定在这一位置处(参见图 8F)。附接销181可包括螺栓181a和螺母181b。替代狭缝102a/102b,也可采用在宽度方向上布置在100a和100b上的一系列孔 103a/103b(参见图8H)来提供离散的止动位置以便调节用来覆盖脊椎的护罩的宽度。
在另一个实施方案中并且如图8I所示,联接元件的联接机构或链环可采用被构造成与一系列孔口配对的一系列突出的形式。联接元件被构造成横向地跨过脊柱以接合骨固定组件(未示出)的脊椎联结构件(杆)。在这种情况下,在护罩的所述两个半部之间的固定可通过在突出与孔口之间直接联接来完成。联接机构360包括被设定尺寸并且被构造成接合脊椎联结构件(杆)的侧向或侧钩件368a和368b。连接构件366a从钩件368a延伸并且连接构件366b从钩件368b延伸。连接构件366b包括可均匀地沿其长度隔开的一系列突出364。连接构件366a包括可沿其长度均匀地隔开并且被构造成与连接构件366b的突出364配对的一系列孔口365。突出364应与孔口365的外部表面齐平。在钩件368a与368b之间的横向长度LL相对于突出364与孔口365的配对或联结而是可调节的,所述横向长度LL可调节成使得一个或多于一个突出与一个或多于一个孔口配对。
图9A和图9B示出图6M的附接到脊柱的联接元件的实施方案。图9A示出本实用新型,其中联接元件处于闭合位置中,而图9B示出本实用新型,其中联接元件处于打开位置中。如先前所述,联接元件可以是被构造成横向地跨过脊柱的脊椎以接合安装在脊柱任一侧上的脊椎联结构件(杆)200的链环350的形式。链环350包括被设定尺寸并且被构造成接合脊椎联结构件200的侧钩件358a和358b。链环350还包括从钩件358b延伸的连接构件356b和从钩件358a延伸的连接构件356a。连接构件356a的远端包括螺栓352并且连接356b 的远端包括伸长的端口355以用于接收螺栓352以便可滑动地连接连接构件。护罩370可附接到联接机构的顶部。护罩370和脊椎联接元件的布置允许护罩一个堆叠在另一个的顶部以便沿脊柱形成连续但柔性的护罩。
如在图9A和图9B中所示,外科手术套件可包括一个护罩,或者可包括多于一个护罩。例如,外壳手术套件可包括2个、3个、4 个、…、n个护罩。当使用多于一个护罩时,所述护罩变得沿脊柱一个堆叠在另一个之上。每个护罩被设计成覆盖一个脊椎。如果多于一个脊椎需要被覆盖,那么将采用多于一个护罩并且每个护罩覆盖一个脊椎。
图10A和图10B示出本实用新型的到骨固定组件的附接。在图 10A中,护罩370的实施方案通过钩件358a和358b到脊椎联结构件 (杆)200的连接而连接到棘突的尾部脊。图10B示出当棘突与护罩之间的距离被闭合并且将本实用新型搭扣到头向脊时护罩370的实施方案。
在上文所述的各个实施方案中,骨固定组件、将骨固定组件与护罩联接的联接元件以及护罩可由多种生物相容性材料(诸如金属、金属合金、聚合物材料),包括生物可吸收材料(诸如聚乳酸、聚乙醇酸,聚-ε-己内酯或其混合物或共聚物)制成。可以使用的材料的实例包括不锈钢(SST)、镍钛(NiTi)或聚合物。可使用的其他金属的实例包括超弹性NiTi、形状记忆NiTi、Ti-Nb、约55-60重量%Ni的Ni-Ti、Ni-Ti-Hf、 Ni-Ti-Pd、Ni-Mn-Ga、300至400系列304、316、402、440SST、MP35N、 17-7PH SST、其他弹簧钢或其他高抗拉强度材料或生物相容性金属材料。在一个优选实施方案中,所述材料是超弹性或形状记忆NiTi,而在第二优选实施方案中,所述优选材料是SST。
可替代地,护罩可由聚合物形成。聚合物的实例包括聚酰亚胺、 PEEK、尼龙、聚氨酯、聚对苯二甲酸乙二酯(PET)、乳胶、HDHMWPE 和热塑性弹性体。
取决于材料以及在柔性方面的结构要求,护罩在任意点处的壁厚度可以例如从约0.05mm变化至2mm,例如,从0.05mm变化至约1mm、约0.1mm、0.2mm、0.3mm、0.4mm、0.5mm、0.6mm、0.7 mm、0.8mm、0.9mm、1.0mm等。护罩的内部直径可以例如从约 0.1mm变化至约2mm,或从约0.25mm变化至约1mm,例如约0.2 mm,约0.3mm,约0.4mm,约0.5mm,约0.6mm,约0.7mm,约 0.8mm,约0.9mm,约1mm,约2mm,约2.5mm,约3mm的厚度。
脊柱保护护罩100可以被浸透有或涂覆有一种或多种治疗剂或药剂,诸如抗再狭窄剂、抗纤维化剂或抗炎剂、抗生素或任何这些制剂的组合。可将这类制剂浸透在被涂覆于保护护罩上的控制-释放层中。所述控制释放层可由蛋白质,诸如胶原蛋白、纤维蛋白、原弹性蛋白、弹性蛋白,交联原弹性蛋白和细胞外基质组分、纤维蛋白、纤连蛋白、层粘连蛋白、其衍生物或其他生物制剂或任意这些的混合物形成。
治疗剂或药剂可以被封装、嵌入或悬浮在生物相容性基质(诸如凝胶)中。所述凝胶可以是可被干燥和重新水合的水凝胶。所述基质可以由可以是半透性的盖封装。所述盖可以是半渗透性的膜、薄片、薄膜、胶带或任何其他希望的构型。
所述盖可具有多个孔、微孔、狭缝,或可由原纤维的多孔网络,或由一个可变密度的原纤维底板或任何其他希望的穿孔形成。所述治疗剂或药剂可在一定时间t内被均匀地递送。可替代地,所述治疗剂或药剂独立于时间和并入本装置的药学活性剂的浓度以一定速率被释放。零级释放确保在希望时间长度内释放稳定量的药物,从而最小化可能的峰值/波谷波动和副作用,同时最大化药物浓度保留在治疗窗内的时间量。
并入治疗剂或药剂的层可以是处于椎板盖外部表面上的涂层。并入所述制剂的层也可使用螺旋胶带构型卷绕所述椎板盖。来自吸载制剂的基质的层或涂层可使用标准技术施加到椎板盖以覆盖椎板盖的整个或部分表面。所述涂层可以是药物和基质的单层均质混合物或呈组合物点阵图案。椎板盖可用包括至少一种药剂或治疗剂的液体溶液浸泡或喷涂。在施加每层之后,在施加下一层之前使椎板盖干燥。并入治疗剂或药剂层的厚度可在约0.1μm至约150μm,约1μm至约 100μm,约10μm至约50μm,或约20μ至30μm范围中。可替代地,可将多层活性剂/基质组合物施加在这些厚度范围中的盖的表面上。例如,多层各种药学活性剂可沉积到盖上,使得特定药物可被一次性释放。
并入药剂的层或涂层还可包括基质。所述基质可包括水溶性材料或遇水膨胀性材料。可将治疗剂或药剂分散在基质内或涂覆在基质外部和/或内部表面上。水溶性材料是指与水或含水生理流体(诸如血和间质液)接触时溶解、水解、分解或崩解的材料。当水溶性材料层溶解时,治疗剂或药剂被释放。水溶性材料被溶解所需的时间长度可以小于2小时、小于1小时、小于30分钟、小于10分钟、小于5分钟、或小于1分钟。
所述基质可包括水不溶性材料和水溶性材料的混合物。所述组合的实例包括紫胶和聚乙烯吡咯烷酮,和乙基纤维素和羟丙基甲基纤维素。所述基质也可包括遇水膨胀性材料。水溶性材料或遇水膨胀性材料可包括多糖,诸如右旋糖、藻酸盐、直链淀粉、支链淀粉、角叉菜聚糖、羧甲基纤维素、结冷胶、瓜尔胶、多糖结合疫苗、羟乙基纤维素、支链淀粉、淀粉衍生物、透明质酸、淀粉衍生物、黄原胶、木葡聚糖、壳聚糖水凝胶、肽聚糖和蛋白聚糖(progeogl yeans)。水溶性材料或遇水膨胀性材料也可包括简单的糖类,诸如葡萄糖、麦芽糖、乳糖、果糖、蔗糖、半乳糖、葡糖胺、半乳糖胺、胞壁酸、葡萄糖醛酸苷、葡糖酸盐、果糖、海藻糖;合成聚合物,诸如聚乙烯基醇、聚乙烯吡咯烷酮、聚乙二醇、丙二醇、聚氧乙烯衍生物;多肽,诸如弹性蛋白、聚乙烯胺或聚(L-赖氨酸)、未交联水凝胶、交联水凝胶、聚丙烯酸或任何其他交联遇水膨胀性聚合物。水凝胶材料的实例包括羧甲基纤维素(CMC)、羟丙基甲基纤维素(HPMC)、支链淀粉、淀粉衍生物、透明质酸或它们的组合。
并入药学活性剂的基质也可以包括许多希望的生物相容性无毒材料。生物相容性材料的实例包括聚(丙交酯-共-乙交酯),聚酯(诸如聚乳酸、聚乙醇酸、聚酐、聚己内酯、聚羟基丁酸酯戊酸酯)或其共聚物的混合物。在一个实施方案中,基质还可包括天然存在的物质,诸如胶原蛋白、纤连蛋白、玻连蛋白、弹性蛋白、层粘连蛋白、肝素、纤维蛋白、纤维素,碳或细胞外基质组分。可在基质中使用的聚合物包括聚(乳酸-共-乙交酯);聚-DL-丙交酯,聚-L-丙交酯,和/或其混合物,并且可以具有各种固有粘度和分子量。在一个实施方案中,可使用聚(DL-丙交酯-共-乙交酯)。聚-DL-丙交酯材料可以是均质组合物形式,并且当被溶解和干燥时,它可形成通道网格,在所述通道网格中药学物质或治疗物质可被捕集以用于递送至组织。在另一个实施方案中,涂层组合物包括不能吸收的聚合物,诸如乙烯醋酸乙烯酯 (EVAC)、聚甲基丙烯酸丁酯(PBMA)和甲基丙烯酸甲酯(MMA)。
所述基质还可包括有机凝胶,诸如聚(乙烯)、L-丙氨酸、脱水山梨醇单硬脂酸酯、尤特奇或卵磷脂有机凝胶。可替代地,凝胶可包括溶胶-凝胶。在另一个实施方案中,所述基质可包括可卷绕椎板盖的胶带(诸如生物粘合剂)。例如,可以使用聚合成薄柔性膜的烷基氰基丙烯酸酯单体。可使用烷基链氰基丙烯酸酯,诸如甲基-、乙基-、异丙基、丁基和氰基丙烯酸辛酯。其他可能的生物粘合剂包括尿烷基材料以及并入贝类粘合蛋白的粘合剂。
并入治疗剂或药剂的层或涂层可分散在由具有多个空点的非水凝胶聚合物制成的类海绵膜或层内或分散到其上。类海绵膜或层可替代地也可由基于聚合物的纤维网络或脚手架构造,从而导致空点空间存在于纤维状网络或纤维结节的网络内。将治疗剂或药剂注入叠置在此椎板盖上的海绵膜或层的空点中。所述治疗剂或药剂通过海绵膜或层的空点排出。海绵膜或层可通过将非水凝胶聚合物溶解在溶剂和可洗脱颗粒材料中来制备。在海绵膜或层组合物被固化之后将其被暴露在溶剂(例如水)中,这引起颗粒材料从聚合物洗脱,从而留下在其中具有多个空点的海绵膜或层。然后将海绵涂层暴露于生物活性材料下以使海绵膜或层吸载有这类材料。可通过扩散或其他方式将这类材料吸载到涂层中。用于形成海绵膜或层的非水凝胶聚合物应该是是生物相容性的那些材料。非水凝胶聚合物是当将水滴添加到这类聚合物薄膜的顶部上时,所述水滴将不会扩散的聚合物。这类聚合物的实例包括但不限于聚氨酯、聚异丁烯及其共聚物、硅树脂和聚酯。其他合适的聚合物包括聚烯烃、聚异丁烯、乙烯-α-烯烃共聚物、高密度高分子量聚乙烯(HDHMWPE)、丙烯酸聚合物和共聚物、乙烯基卤化物聚合物和共聚物(诸如聚氯乙烯)、聚乙烯醚(诸如聚乙烯基甲基醚)、聚乙烯基卤化物(诸如聚偏二氟乙烯和聚偏二氯乙烯)、聚丙烯腈、聚乙烯酮、聚乙烯基芳族化合物(诸如聚苯乙烯)、聚乙烯酯(诸如聚醋酸乙烯);乙烯基单体的共聚物、乙烯基单体和烯烃的共聚物(诸如乙烯- 甲基丙烯酸甲酯共聚物)、丙烯腈-苯乙烯共聚物、ABS树脂、乙烯- 醋酸乙烯酯共聚物、聚酰胺(诸如尼龙66和聚己内酯)、醇酸树脂、聚碳酸酯、聚氧乙烯、聚酰亚胺、聚醚、环氧树脂、聚氨酯、人造丝- 三乙酸酯、纤维素、乙酸纤维素、丁酸纤维素、乙酸丁酸纤维素、玻璃纸、硝酸纤维素、丙酸纤维素、纤维素醚、羧甲基纤维素、胶原、甲壳质、聚乳酸、聚乙醇酸和聚乳酸-聚环氧丙烷共聚物。
可将治疗剂或药剂并入到被并入基质中的微球、脂质体和其他类型的基于颗粒的药物递送载体。例如,可将聚(乳酸-共-乙醇酸)纳米颗粒并入可交联的基于透明质酸水凝胶基质内。可替代地,所述基质可包括用于封装治疗剂或药剂纳米凝胶。纳米凝胶是由聚乙二醇 (PEG)链段交联的带电荷聚离子链段的聚合物网络。可将多种不同的药剂并入纳米凝胶中。
抗再狭窄剂的实例包括但不限于,紫杉醇、药学活性紫杉醇衍生物、雷帕霉素、药学活性雷帕霉素衍生物、合成的基质金属蛋白酶抑制剂(诸如巴马司他(BB-94))、细胞可渗透霉菌毒素(诸如细胞松弛素 B)、基因靶向的治疗药物、c-myc带中性电荷的反义寡核苷酸(诸如非肽抑制剂(诸如替罗非班))、抗过敏药物(诸如曲尼司特)、基于基因的治疗物(诸如紫杉醇),以及其组合。
抗纤维化剂的实例包括但不限于:降低或引起溶解或纤维化组织或其部分的收缩的制剂;在酶催化下降解或收缩纤维化组织的制剂 (诸如蛋白酶或聚糖酶);抑制胶原蛋白产生并且刺激胶原蛋白降解的激素(诸如松弛素);影响纤维化组织中的成纤维细胞或其他细胞的功能、生命力或增殖的基于细胞因子、药物、细胞或核酸的材料;或抑制胶原蛋白产生和/或刺激胶原蛋白降解的细胞。抗纤维化剂的特定实例包括藻酸盐、硫酸软骨素、硫酸皮肤素、葡聚糖硫酸盐、透明质酸、肝素、硫酸肝素、硫酸角质素和戊糖多硫酸、或其组合。
抗炎剂的实例(在没有脊柱融合被涉及,因为抗炎性将阻碍脊柱融合的情况下)包括但不限于:萘普生;双氯芬酸;塞来昔布;舒林酸;二氟尼柳;吡罗昔康;吲哚美辛;依托度酸;美洛昔康;布洛芬;酮洛芬;r-氟比洛芬;甲灭;萘丁美酮;托美丁(tolmetin),和上述中每一种的钠盐销售(sodium sales of each of the foregoing);痛力克溴甲胺;酮咯酸氨丁三醇;酮咯酸;三水杨酸胆碱镁;罗非昔布;伐地考昔;罗美昔布;依托考昔;阿司匹林;水杨酸及其钠盐;α,β,γ-生育酚和生育三烯酚(及其所有d,1,和外消旋异构体(isoler))的水杨酸酯;甲基,乙基,丙基,异丙基,正丁基,仲丁基,叔丁基,乙酰水杨酸酯;替诺昔康;醋氯芬酸;尼美舒利;奈帕芬胺;氨芬酸;溴芬酸;氟芬那酸;保泰松或其组合。
抗生素的实例包括但不限于:氨基糖苷类(诸如链霉素、阿米卡星和妥布霉素);大环内酯(诸如红霉素、克拉霉素和林可霉素);四环素(诸如四环素、强力霉素、金霉素和米诺环素);为合成的恶唑酮类(诸如利奈唑胺);夫西地酸;和氯霉素;β-内酰胺青霉素(诸如青霉素、阿莫西林、双氯西林和氨苄青霉素);β-内酰胺头孢菌素(诸如头孢噻肟、头孢呋辛、头孢克洛和头孢曲松);β-内酰胺碳青霉烯类(诸如亚胺培南和美罗培南);喹诺酮类(诸如环丙沙星、莫西沙星和左氧氟沙星);磺胺类药物(诸如磺胺和磺胺甲恶唑);甲硝唑;利福平;万古霉素;和呋喃妥因。
可以在本实用新型中使用的药剂包括:(i)药剂,诸如(a)抗血栓形成剂(诸如肝素、肝素衍生物、尿激酶和PPack(右旋苯丙氨酸脯氨酸精氨酸氯甲基酮);抗炎剂,诸如地塞米松、泼尼松龙从、皮质酮、布地奈德、雌激素、柳氮磺吡啶和氨水杨酸;(c)抗肿瘤剂/抗增殖剂/ 抗缩瞳剂如紫杉醇、5-氟尿嘧啶、顺钼、长春碱、长春新碱、埃博霉素、内皮他汀、血管他汀、血管肽素、能够阻断平滑肌细胞增殖的单克隆抗体、胸苷激酶抑制剂、雷帕霉素、40-0-2(羟基乙基)雷帕霉素(依维莫司)、40-0-苄基-雷帕霉素、40-0(4'-羟甲基)苄基-雷帕霉素、 40-0-[[4'-(1,2-二羟基乙基)]苄基-雷帕霉素、40-稀丙基-雷帕霉素、 40-0-[[3’-92,2-二甲基-1,3-二氧戊环-4(S)-基-丙-p-2’-烯-l’基)]-20雷帕霉素、(2’:E,4’S)-40-0-(4’,5’.:二轻基戊-2'烯-l'基)雷帕霉素、40-0(2-羟基)乙氧基羰基甲基-雷帕霉素、40-0-(3-羟基丙基)-雷帕霉素40-0-((羟基)己基-雷帕霉素40-0-[[2-(2-羟基)乙氧基]乙基-雷帕霉素、 40-0-[[(3S)-(羟基)己基-雷帕霉素40-0-[[2-(2-羟基)乙氧基]乙基-雷帕霉素、40-0-[[(3S)-2,2-二甲基二氧戊环-3-基]甲基-雷帕霉素、40-0-(2- 乙酰氧基)乙基-雷帕霉素、40-0[[2-(N-甲基-N’-哌嗪基)乙酸基]乙基- 雷帕霉素、39-0-去甲基-3.9、400-0,0亚乙基-雷帕霉素、(26R)-26-二氢-40-0-(2-羟基)乙基-雷帕霉素、28-O甲基雷帕霉素、40-0-(2-氨基乙基)-雷帕霉素、40-0-(2-乙酰氨基乙基)-雷帕霉素40-0(2-烟酰胺基乙基)-雷帕霉素、40-0-(3-(N-甲基-咪唑-2'基甲酰胺基)乙基)-30雷帕霉素、40-0-(2-乙氧基幾基氨基乙基)-雷帕霉素、40-0-(2-甲苯基亚横酰氨基乙基)-雷帕霉素、40-0-(2-甲苯基磺酰氨基乙基)-雷帕霉素、 40-0-(2-乙氧基羰基氨基乙基)-雷帕霉素、40-0-(2-甲苯基磺酰氨基乙基)-雷帕霉素、40-0-[[2-(4’,5’-二乙酯基-1’,2’,3’-三唑-l’-基0-乙基]雷帕霉素、42-Epi-(四唑)雷帕霉素(他克莫司)、以及42-[3-羟基-2-(羟甲基)-3-甲基丙酸酯]雷帕霉素(他克莫司),(d)麻醉剂,诸如利多卡因、布比卡因和罗哌卡因;€抗凝剂,诸如D-苯丙-脯-精氨酸氯甲基酮和含RGD多肽的化合物、肝素、水蛭素、抗凝血酶化合物、血小板受体拮抗剂、抗凝血酶抗体、抗血小板受体抗体、阿司匹林、前列腺素抑制剂、血小板抑制剂和蜱抗血小板肽;(f)血管细胞生长促进剂,诸如生长因子、转录激活因子和翻译促进剂;(g)血管细胞生长抑制剂,诸如生长因子抑制剂、生长因子受体拮抗剂、转录阻抑物、翻译阻抑物、复制抑制剂、抑制性抗体、定向抑制生长因子的抗体、由生长因子和细胞毒素组成的双功能分子、由抗体和细胞毒素组成的双功能分子;(h)蛋白激酶和酪氨酸激酶抑制剂(例如,酪氨酸磷酸化抑制剂、染料木黄酮、喹恶啉类);(i)前列环素类似物;(j)降胆固醇降低剂;(k) 血管生成素;(l)抗微生物剂,诸如三氯生、头孢菌素类、氨基糖苷类和呋喃妥因;m)细胞毒性剂、细胞生长抑制剂和细胞增殖效应物;(n) 血管扩张剂;以及(o)干扰内源性血管活性机制的制剂,(ii)基因治疗剂,其包括反义DNA和RNA,以及编码以下的DNA:(a)反义RNA, (b)tRNA或rRNA以替换有缺陷,或碱性成纤维细胞生长因子、血管内皮生长因子、表皮生长因子、转化生长因子a和P、源于血小板的内皮生长因子、源于血小板的生长因子、肿瘤坏死因子a、肝细胞生长因子和胰岛素样生长因子,(d)细胞周期抑制剂,其包括CD抑制剂,以及€胸苷激酶(“TK”和用于干扰细胞增殖的其他制剂。
可以使用的其他药剂包括:阿卡波糖、抗原、β-受体阻断剂、非留体抗炎药(NSAID、强心苷、乙酰水杨酸、病毒抑制剂、阿柔比星、阿昔洛韦、顺钼、放线菌素、α-和β-拟交感神经药、(奥美拉唑、别嘌呤醇、前列地尔、前列腺素、金刚烷胺、氨溴素、氨氯地平、甲氨蝶呤、S-氨基水杨酸、阿米替林、阿莫西林、阿那曲唑、阿替洛尔、硫唑嘌呤、巴柳氮、倍氯米松、倍他司汀、苯扎贝特、比卡鲁胺、地西泮和地西泮衍生物、布地奈德、丁苯羟酸、丁丙诺啡、美沙酮、钙盐、钾盐、镁盐、坎地沙坦、卡马西平、卡托普利、头孢菌素、西替利嗪、鹅去氧胆酸、熊去氧胆酸、茶碱和茶碱衍生物、胰蛋白酶、西咪替丁、克拉霉素、克拉维酸、克林霉素、氯丁替诺、可乐定、磺胺甲基异恶唑、可待因、咖啡因、维生素D和维生素D的衍生物、考来烯胺、色甘酸、香豆素和香豆素衍生物、半胱氨酸、阿糖胞苷、环磷酰胺、环孢素、环丙孕酮、阿糖胞苷、达哌挫、去氧孕稀、地奈德、双肼屈嗪、地尔硫卓、麦角生物碱、茶苯海明、二甲基亚砜、二甲硅油、多潘立酮和多潘立酮衍生物、多巴胺、多沙唑嗪、多柔比星、多西拉敏、达哌唑、苯二氮卓类、双氯芬酸、糖苷类抗生素、地昔帕明、益康唑、ACE抑制剂、依那普利、麻黄碱、肾上腺素、促红细胞生成素和促红细胞生成素衍生物、吗啡烷类、钙拮抗剂、依利替康、莫达非尼、奥利司他、肽抗生素类、苯妥英、利鲁挫、利塞膦酸盐、西地那非、托吡醋、大环内酯类抗生素、雌二醇和雌二醇衍生物、孕激素和孕激素衍生物、睾酮和睾酮衍生物、雄激素和雄激素素衍生物、乙水杨胺、依托酚那酯、依托贝特、非诺贝特、乙轻茶碱、依托泊苷、泛昔洛韦、法莫替丁、非洛地平、非诺贝特、芬太尼、芬替康挫、回旋酶抑制剂、氟康挫、氟达拉滨、氟桂利嗪、氟尿喃啶、氟西汀、氟比洛芬、布洛芬、氟他胺、氟伐他汀、促滤泡素、福莫特罗、磷霉素、呋塞米、夫西地酸、戈洛帕米、更昔洛韦、吉非贝齐、庆大霉素、银杏、圣约翰草、格列本脲、作为口服抗糖尿病药的尿素衍生物、高血糖素、葡糖胺和葡糖胺衍生物、谷胱甘肽、甘油和甘油衍生物、下丘脑激素、戈舍瑞林、回旋酶抑制剂、胍乙啶、卤泛群、氟呱啶醇、肝素和肝素衍生物、透明质酸、肼屈嗪、氢氯噻嗪和氢氯噻嗪衍生物、水杨酸盐类、羟嗪、伊达比星、异环磷酰胺、丙咪嗪、吲哚美辛、吲哚拉明、胰岛素、干扰素类、碘和碘衍生物、异康唑、异丙肾上腺素、葡糖醇和葡糖醇衍生物、伊曲康唑、酮康唑、酮洛芬、酮替芬、拉西地平、兰索拉唑、左旋多巴、左美沙酮、甲状腺激素类、硫辛酸和硫辛酸衍生物、赖诺普利、利舒脲、洛非帕明、洛莫司汀、洛哌丁胺、氯雷他定、马普替林、甲苯达唑、美贝维林、美克洛嗪、甲芬那酸、甲氟喹、美洛昔康、甲吲洛尔、甲丙氨醋、美罗培南、美沙拉秦、甲琥胺、安替比林甲胺甲烧、二甲双胍、甲氨蝶呤、哌甲酯、甲泼尼龙、美噻吨、甲氧氯普胺、美托洛尔、甲硝挫、米安色林、咪康唑、米诺环素、米诺地尔、米索前列醇、丝裂霉素、咪唑斯汀、莫昔普利、吗啡和吗啡衍生物、月见草、纳布啡、纳洛酮、替利定、萘普生、那可汀、那他霉素、新斯的明、尼麦角林、尼可刹米、硝苯地平、尼氟酸、尼莫地平、尼莫唑、尼莫司汀、尼索地平、肾上腺素和肾上腺素衍生物、诺氟沙星、甲哌氯丙嗪砜、那可汀、制霉菌素、氧氟沙星、奥氮平、奥沙拉秦、奥美拉唑、奥莫康唑、昂丹司琼、奥沙西罗、苯唑西林、奥昔康唑、羟甲唑啉、泮托拉唑、对乙酰氨基酚、帕罗西汀、喷昔洛韦、口服青霉素类、喷他佐辛、喷替茶碱、己酮可可碱、奋乃静、哌替啶、植物提取物、安替比林、非尼拉敏、巴比妥酸衍生物、保泰松、苯妥英、匹莫齐特、吲哚洛尔、哌嗪、吡拉西坦、哌仑西平、吡贝地尔、吡罗昔康、普拉克索、普伐他汀、哌唑嗪、普鲁卡因、丙嗪、丙哌维林、普萘洛尔、异丙安替比林、前列腺素类、丙硫异烟胺、丙羟茶碱、喹硫平、喹那普利、喹普利拉、雷米普利、雷尼替丁、瑞普特罗、利血平、利巴韦林、利福平、利培酮、利托那韦、罗匹尼罗、罗沙替丁、罗红霉素、鲁斯可皂苷元、芦丁和芦丁衍生物、沙巴达、沙丁胺醇、沙美特罗、东茛菪碱、司来吉兰、舍他康唑、舍吲哚、舍曲林、硅酸盐类、西地那非、辛伐他汀、谷留醇、索他洛尔、司谷氨酸、司帕沙星、大观霉素、螺旋霉素、螺普利、螺内酯、司他夫定、链霉素、硫糖铝、舒芬太尼、舒巴坦、磺胺类、柳氮磺吡啶、舒必利、舒他西林、舒噻美、舒马普坦、氯琥珀胆碱、他克林、他克莫司、他林洛尔、他莫昔芬、牛磺罗定、他扎罗汀、替马西泮、替尼泊苷、替诺昔康、特拉唑嗪、特比萘芬、特布他林、特非那定、特利加压素、特他洛尔、四环素类、四氢唑林、可可碱、茶碱、布替嗪、甲疏咪挫、吩噻嗪类、塞替派、噻加宾、硫必利、丙酸衍生物、噻氯匹定、噻吗洛尔、替硝唑、噻康唑、硫鸟嘌呤、噻克索酮、替罗拉胺、替扎尼定、妥拉挫林、甲苯磺丁脲、托卡朋、托萘醋、托哌酮、拓扑替康、托拉塞米、抗雌激素药、曲马多、曲马唑啉、群多普利、反苯环丙胺、曲匹地尔、曲唑酮、曲安西龙和曲安西龙衍生物、氨苯蝶啶、三氟哌多、曲氟尿苷、甲氧苄啶、曲米帕明、曲吡那敏、曲普利啶、曲磷胺、曲金刚胺、氨丁三醇、三苯乙醇、曲克芦丁、妥洛特罗、酪胺、短杆菌素、乌拉地尔、熊去氧胆酸、鹅去氧胆酸、伐昔洛韦、丙戊酸、万古霉素、维库氯按、万艾可、文拉法辛、维拉帕米、阿糖腺苷、氨己稀酸、维洛沙秦、长春碱、长春胺、长春新碱、长春地辛、长春瑞滨、长春西汀、维喹地尔、华法林、尼可占替诺、希帕胺、扎鲁司特、扎西他滨、齐多夫定、佐米曲普坦、挫吡坦、佐匹克隆、佐替平等。
虽然本实用新型已经具体示出并参考具体实施方案描述,但是应理解,上述公开的和其他特征和功能或其替代物的变体可以理想地组合到许多其他不同的系统或应用中。此外,在其中的各种替代方案,修改,变化或改进可对本领域技术人员是显而易见的,并且随后可由本领域技术人员做出这些替代方案,修改,变化或改进,这也旨在包含在以下权利要求范围内。
Claims (39)
1.一种外科手术套件,其特征在于包括:
用于覆盖受试者脊柱的一部分的护罩,所述护罩包括适于接合骨固定组件的附接部分,所述骨固定组件适于被固定在所述受试者的多个椎骨上。
2.如权利要求1所述的外科手术套件,其特征在于所述骨固定组件包括固定在两个骨锚之间的至少一个脊椎联结构件,每个骨锚包括适于植入椎骨中的紧固件部分和适于固定所述脊椎联结构件的头部联接部分。
3.如权利要求2所述的外科手术套件,其特征在于所述护罩的所述附接部分适于接合所述骨固定组件的所述脊椎联结构件。
4.如权利要求2所述的外科手术套件,其特征在于所述护罩的所述附接部分适于接合所述骨固定组件的所述骨锚中的至少一个。
5.如权利要求2所述的外科手术套件,其特征在于所述护罩的所述附接部分包括钩件部分。
6.如权利要求2所述的外科手术套件,其特征在于所述护罩具有可调节的横向宽度。
7.如权利要求6所述的外科手术套件,其特征在于所述护罩包括两个零件,其各自包含用于接合所述骨固定组件的脊椎联结构件的一个钩件,所述两个零件彼此适于在多个侧向点处接合。
8.如权利要求2所述的外科手术套件,其特征在于所述护罩具有垂直长度以覆盖至少两个脊椎。
9.如权利要求2所述的外科手术套件,其特征在于还包括适于将所述护罩的所述附接部分固定到所述骨锚中的一个的至少一个联接元件。
10.如权利要求2所述的外科手术套件,其特征在于还包括适于将所述护罩的所述附接部分固定到所述脊椎联结构件的至少一个联接元件。
11.如权利要求9或10所述的外科手术套件,其特征在于所述联接元件是具有开口端的夹具。
12.如权利要求2所述的外科手术套件,其特征在于所述骨固定组件包括各自固定在两个骨锚之间的至少两个脊椎联结构件,所述外科手术套件还包括适于接合所述两个脊椎联结构件中的每一个的链环,其特征在于所述链环包括彼此处于可滑动构型的两个连接构件以便允许调节所述链环的横向长度。
13.如权利要求12所述的外科手术套件,其特征在于所述护罩包括各自附连到所述链环的所述两个连接构件的相应构件的两个零件,当所述链环的所述两个连接构件相对于彼此移动时,可调节在所述两个零件之间的侧向距离。
14.如权利要求2所述的外科手术套件,其特征在于所述骨固定组件包括各自固定在两个骨锚之间的至少两个脊椎联结构件以及适于接合所述两个脊椎联结构件中的每一个的链环,其特征在于所述链环包括具有多个孔口的第一连接构件和具有多个突出的第二连接构件,所述孔口和所述突出能够配对在一起并且当所述第一连接构件和所述第二连接构件相对于彼此移动时是可调节的。
15.如权利要求2所述的外科手术套件,其特征在于所述护罩的所述附接部分包括至少一个孔。
16.如权利要求1所述的外科手术套件,其特征在于所述护罩包括伸长的凹面。
17.如权利要求1所述的外科手术套件,其特征在于所述附接部分包括在所述护罩的相对侧上侧向地延伸的两个零件。
18.如权利要求1所述的外科手术套件,其特征在于所述护罩由聚合物材料制成。
19.如权利要求1所述的外科手术套件,其特征在于所述护罩由包括PEEK的材料制成。
20.如权利要求1所述的外科手术套件,其特征在于所述护罩还包括选自抗狭窄剂、抗纤维化剂、抗炎剂和抗生素剂的至少一种治疗剂。
21.如权利要求20所述的外科手术套件,其特征在于所述至少一种治疗剂被嵌入生物相容性基质中。
22.如权利要求21所述的外科手术套件,其特征在于所述基质由半透性盖封装。
23.如权利要求21所述的外科手术套件,其特征在于所述基质还包括水溶性材料。
24.一种用于覆盖脊柱的一部分的护罩,其特征在于所述护罩由附接部分固定到骨固定组件,其特征在于所述附接部分被构造成可移除地附接到所述骨固定组件。
25.如权利要求24所述的护罩,其特征在于所述骨固定组件包括骨螺钉。
26.如权利要求25所述的护罩,其特征在于还包括通过脊椎联结构件连接的至少两个骨螺钉。
27.如权利要求26所述的护罩,其特征在于所述脊椎联结构件是杆。
28.如权利要求27所述的护罩,其特征在于所述杆具有可伸缩构型。
29.如权利要求27所述的护罩,其特征在于所述附接部分包括联接元件。
30.如权利要求29所述的护罩,其特征在于所述联接元件是夹具。
31.如权利要求30所述的护罩,其特征在于所述夹具形成奥米伽形状。
32.根据权利要求29所述的护罩,其特征在于所述联接元件包括被构造成可移除地附接到所述杆的至少两个侧钩件以及设置在所述两个钩件之间的连接构件。
33.如权利要求32所述的护罩,其特征在于所述连接构件包括在中心螺钉处可滑动地联结的两个连接构件。
34.如权利要求32所述的护罩,其特征在于所述护罩包括两个半圆顶,其特征在于每个半圆顶固定到一个连接构件。
35.如权利要求29所述的护罩,其特征在于所述联接元件可移除地附接到所述骨螺钉。
36.如权利要求34所述的护罩,其特征在于所述联接元件包括夹具。
37.如权利要求24所述的护罩,其特征在于包括多个护罩,其特征在于相邻护罩以连续的方式堆叠在彼此的顶部。
38.如权利要求37所述的护罩,其特征在于所述附接部分包括联接元件,所述联接元件包括两个侧钩件和连接构件。
39.一种用于覆盖脊柱的一部分的护罩,其特征在于包括两个侧向零件,其特征在于每个侧向零件包括护罩部分和钩件部分,所述护罩通过附接部分固定到骨固定组件,并且所述附接部分被构造成可移除地附接到所述骨固定组件。
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Effective date of registration: 20240130 Address after: No.1, Floor 5, No. 88, Section 2, Chongqing North Road, Datong District, Taiwan, China, China Patentee after: Xinwangsheng Medical Co.,Ltd. Country or region after: Taiwan, China Address before: Taipei City, Taiwan, China Patentee before: ORION BIOTECH Inc. Country or region before: Taiwan, China |