CN113143355A - 多护罩脊柱进入系统 - Google Patents
多护罩脊柱进入系统 Download PDFInfo
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- CN113143355A CN113143355A CN202110037202.3A CN202110037202A CN113143355A CN 113143355 A CN113143355 A CN 113143355A CN 202110037202 A CN202110037202 A CN 202110037202A CN 113143355 A CN113143355 A CN 113143355A
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- shield
- end portion
- outer shield
- distal end
- inner shield
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- 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
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
- A61F2/4611—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
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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
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
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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
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
- A61F2002/30556—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting thickness
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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
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2002/4635—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using minimally invasive surgery
Abstract
本发明提供了一种用于进入椎间盘的进入装置,该进入装置具有外部护罩,该外部护罩包括具有从皮肤向下到达小关节线的较大直径(约16至30mm)的进入护罩;以及内部护罩,该内部护罩具有延伸穿过进入护罩并向下到达椎间盘水平面的第二较小直径(约5至12mm)。这结合了直接视觉显微手术/小切口方法和经皮“超‑MIS”技术的优点。
Description
背景技术
现今,通过微开管和牵开器在显微镜视图下进行的显微外科脊柱骨切除术和脊柱减压术正在成为脊柱手术护理的标准。这些进入工具通常具有在16mm与30mm之间的内径。这里,在脊柱外科医生熟悉入路和减压技术的情况下,以及在可以使用标准设备和器械的情况下,应当将这些已知技术视为可以进一步创新的基础。
然而,进行安全椎间盘进入所穿过的Kambin三角区的解剖窗口的尺寸非常有限。可以通过切除上关节突的至少一部分来放大该进入窗口。但无论如何,经由这种入路将植入物安全地引入到椎间隙所需的工作护罩的长度必须在直径约8mm至12mm的范围内,从而从小关节线到达椎间盘进入点。
发明内容
本发明的发明人设想通过以上提及的第一外部护罩引入第二内部护罩。第二内部护罩延伸经过第一外部护罩以到达紧邻神经组织的位置,由此防护神经使其避开穿过椎间盘间隙的器械或装置。在这个步骤中,外部护罩允许内部护罩的可视安全放置。
在一个实施方案中,提供了一种外部护罩(其可以为例如管或刀片),该外部护罩包括从皮肤向下到达骨线的具有较大直径(约12mm至 30mm)的进入护罩,以及具有第二较小直径(约5mm至12mm)的内部护罩,该内部护罩延伸经过进入护罩并且向下到达椎间盘水平。这将显微外科/微创入路的直接可视的益处和经皮技术相结合(图1a至图b和图 2)。
外部护罩具有多个特征和优点。首先,外部护罩能够在显微镜视图下的标准显微外科减压/骨切除术期间,基于熟悉MIS技术的外科医生能够执行的标准过程,实现周围软组织的分离和保护以及可视化。其次,外部护罩能够在小关节或小关节各部分的检测和移除期间,基于熟悉MIS技术的外科医生能够执行的标准过程,实现周围软组织的分离和保护以及可视化。第三,外部护罩能够在牵开敏感组织和非牵开敏感组织之间的边界 (例如,小关节线)的下方在直接可视控制下,基于熟悉MIS技术的外科医生能够执行的标准过程,实现敏感(例如,神经)组织(穿出神经根、下行神经根、硬脑膜)的识别、制备和保护。第四,外部护罩能够在直接可视控制下,实现内部护罩的插入以及内部护罩在椎间盘间隙中或椎骨上的可能对接。
同样,内部护罩具有多个特征和优点。首先,内部护罩能够保护神经组织(穿出神经根、下行神经根、硬脑膜),使其避开引入到椎间盘中的器械。第二,外部护罩能够引导椎间盘内器械(椎间盘切除器械、可视化器械、椎间盘切除检查器械、植入物插入器械、骨移植物填充器械)。第三,由于外部护罩的尺寸较小,可以以对脊柱后柱区域的骨和软组织的最小的损伤或创伤来插入护罩,这与经皮进入器械相当。
因此,根据本发明,提供了一种进入患者体内的椎间盘的方法,所述方法包括以下步骤:
a)在患者的皮肤中制造切口,
b)通过切口经皮地插入具有基本上管状形状的外部护罩(诸如管或多槽牵开器),所述外部护罩具有适于从切口延伸到患者脊柱中的敏感组织与不敏感组织之间的边界(例如,上关节突(SAP)或椎板)的长度,
c)将这个外部护罩固定到椎弓根锚固件,
d)插入集成了光学可视化器械的外部护罩,
e)切除上关节突的一部分,以及/或者执行显微外科减压手术
F)穿过外部护罩插入内部护罩或从外部护罩展开内部护罩,使得内部护罩的远侧端部部分延伸到椎间盘,内部护罩具有外表面,
g)使护罩的外表面接触神经根以防护神经根,
h)通过显微手术减压被认为导致神经卡压的任何组织,
i)取出椎间盘材料,包括从椎骨终板移除软骨材料,
j)插入椎间体装置,以及
k)部署稳定机构以使椎间节段稳定。
根据本发明,还提供了一种进入患者体内的椎间盘的方法,所述方法包括以下步骤:
a)在患者的皮肤中制造切口,
b)通过切口经皮地插入外部屏蔽件,所述外部屏蔽件具有基本上管状形状,
c)将这个外部护罩固定到椎弓根锚固件,
d)穿过外部护罩插入内部护罩,使得内部护罩的远侧端部部分延伸到椎间盘,内部护罩具有外表面,
e)使护罩的外表面接触神经根以防护神经根,
f)通过显微手术减压被认为导致神经卡压的任何组织,
g)取出椎间盘材料,包括从椎骨终板移除软骨材料,
h)插入椎间体装置,以及
i)部署稳定机构以使椎间节段稳定。
根据本发明,还提供了一种用于进入椎间盘的进入装置,所述进入装置包括:
a)外部护罩,所述外部护罩具有:基本上管状的部分,适于从切口延伸到敏感组织与不敏感组织之间的边界(例如,关节突或椎板)的长度;近侧端部部分;远侧端部部分;外表面;以及限定内表面的纵向通孔,
b)内部护罩,所述内部护罩具有:i)第一基本上管状的部分,所述第一基本上管状的部分具有近侧端部部分、远侧端部部分、限定内表面的纵向通孔和限定直径的外表面;以及ii)纵向凸缘,所述纵向凸缘从基本上管状的部分的远侧端部部分朝远侧延伸,其中内部护罩的外表面基本上嵌套在外部护罩的内表面内,使得
i)凸缘朝远侧延伸经过外部护罩的远侧端部部分。
附图说明
图1a示出了通过进入装置递送的椎间体装置。
图1b示出了进入装置的端视图。
图2a和图2b是进入装置的套管式实施方案的不同视图。
图3a至图3d示出了内部护罩的不同轴向横截面。
图4示出了内部护罩的颈缩漏斗形实施方案。
图5至图6示出了同心和不同心的内部护罩的不同纵向横截面。
图7示出了接合的进入装置。
图8a示出了内部护罩的带凸缘实施方案。
图8b示出了具有近侧止挡件的内部护罩。
图9示出了两个端口附接到外部护罩的进入装置。一个端口是用于保持外管的连接器,而另一个端口是针对光源的接口。
图10公开了外管的横截面,其中外管壁具有适于包含可视化单元(诸如摄像头)的第一通道和适于包含清洁系统(诸如透镜清洁装置)的第二通道。
图11公开了外管的横截面,其中外管壁包含透镜清洁装置和摄像头。
图12公开了顶端芯片实施方案,包括外管的横截面,其中外管壁具有包含内窥镜的通道,所述内窥镜在其远侧端部附近具有视频芯片。
图13公开了外管的远侧端部,所述外管以其远侧端部附近的视频芯片为特征。
图14公开了用于内窥镜的镜架。
图15a至图15b示出了具有近侧弯管的内部护罩。
图16示出了在外部护罩内的内部护罩上具有远侧尖端的进入装置。
图17示出了定位环在内部护罩与外部护罩之间的进入装置。
图18示出了深度调整装置由内部护罩和外部护罩形成的进入装置。
图19公开了整体式牵开器,该整体式牵开器具有容纳于外管245的切出件内的平坦内表面。
图20示出了图48的实施例。
图21公开了牵开器,该牵开器具有容纳于外管内的平坦内表面。
图22至图24b示出了牵开实施方案。
图25至图30示出了具有延伸护罩的进入装置。
图31示出了具有内部护罩和外部护罩的进入装置。
图32至图34示出了内部护罩。
图35公开了径向软组织牵开器。
图36公开了外管/内部牵开器组件,其中第一内部牵开器和第二内部牵开器均向内倾斜以牵开软组织。
图37至图46公开了涉及进入装置的优选外科手术方法。
图47a至图47c公开了导航插塞,该导航插塞包括基座,该基座具有附接到其的阵列,其中插塞适于装配在外管内。
图48公开了从外管的端部延伸出的超声波切割器的曲奇切割器型远侧端部,其中远侧端部具有多个切割齿。
图49a至图49b公开了用于引导骨切割装置的模板的各种横截面。
图50公开了具有半圆形切割件切割器骨头的超声波切割器的曲奇切割器型远侧端部。
图51公开了将外管和螺钉延伸部连接的微型柔性臂。
图52公开了外管/内牵开器组件,其中内牵开器向内倾斜以牵开软组织。
图53公开了外管/内牵开器组件,其中内牵开器与外管平行地运行。
图54公开了容纳于外管内的内窥镜和从外管延伸的内管。
具体实施方式
执行荧光镜透视检查可视化以限定初始参考阵列放置的切口部位以及进入椎间盘的切口。
一般来讲,本发明的护罩能够应用于脊柱手术中常用的任何常规方法。然而,考虑到进入装置的临床益处及其基本原理,优选在椎间盘的椎板间隙入路、椎间孔外入路或经椎间孔入路中使用这些护罩。
现在参见图1至图7,提供了一种用于进入椎间盘的进入装置,该进入装置包括:
a)外部护罩1,该外部护罩具有:基本上管状部分,适于从切口延伸到敏感组织与不敏感组织之间的边界(例如,关节突)的长度;近侧端部部分3;远侧端部部分5;外表面7;以及限定内表面10 的纵向通孔9,
b)内部护罩11,该内部护罩具有:i)第一基本上管状部分13,该第一基本上管状部分具有近侧端部部分15、远侧端部部分17、限定内表面21的纵向通孔19和限定直径的外表面23;以及ii)纵向凸缘25,该纵向凸缘从基本上管状部分的远侧端部部分朝远侧延伸,
其中内部护罩的外表面基本上嵌套在外部护罩的内表面内,使得凸缘朝远侧延伸经过外部护罩的远侧端部部分,并且
内部护罩的基本上管状部分的远侧端部部分朝远侧延伸经过外部护罩的远侧端部。
外部护罩实施方案:
在外部护罩的设计中,可以使用传统的管或对开管/牵开器概念。也可以采用更新的概念,诸如“柔性管”。外部护罩可以是简单的圆柱形管。外部护罩也可以是对开管,这样常规的牵开器被认为是对开管。外部护罩可以是柔性管。外部护罩可以是具有从近侧端部延伸到远侧端部的狭槽的管。各种形状实施方案可以是:
a)具有内径D的圆柱形管(图3a);
b)高度a与长度b不同的椭圆形管(图3b);
c)具有直径D的基本上圆形或椭圆形横截面的“半月形”管,其中截面(或弦)“a”被切割(图3c);和
d)具有高度a和宽度b的矩形管(图3d)。
在一些实施方案中,远侧端部部分5的形状包括不对称形状,以更好地将组织侧向牵开到SAP。
外部护罩可以优选地用于各种进入窗口尺寸,即宽度范围为6mm至 25mm且长度范围为40mm至200mm。通常,外部护罩包括允许附接稳定机构的特征,该稳定机构允许适当附接灵活性(例如,球形接头)。在一个实施方案中,外部护罩具有适于引入内窥镜或摄像头的定制特征,该定制特征允许将内窥镜引入到预定深度,在那里外部护罩的远侧部分处的工作窗口可以被可视化。
内部护罩实施方案:
现在参见图3a至图3d,内部护罩11也可以包含各种设计。
在第一实施方案中,内部护罩是完全包围(即,延伸360度)的刚性管。内部护罩具有各种横截面,诸如:
e)具有内径D的圆柱形管(图3a);
f)高度a与长度b不同的椭圆形管(图3b);
g)具有直径D的圆形横截面的“半月形”管,其中截面(或弦) “a”被切割(图3c);和
h)具有高度a和宽度b的矩形管(图3d)。
内部护罩可以具有不同的纵向形状。例如,在第二实施方案中,并且现在参见图4至图7,内部护罩11是漏斗形(例如,颈缩)管(如图4所示)。在该实施方案中,内部护罩改变了它沿护罩的横截面形状/面积,其中在近侧部分具有较大的直径/工作区域,并且对具有更大直径的这个区域的长度进行调整使其成为内部护罩的将嵌套在外部护罩内的部分,以及具有较小的直径/工作区域,在那里内部护罩使外部护罩延伸。这种设计增加了椎间盘内工具的运动范围并实现了更好的可视化。在图4中,凸缘是第二基本上管状部分25,其直径小于内部护罩的第一基本上管状部分13的直径。颈缩区域27设置在第一基本上管状部分与第二基本上管状部分之间。
在一些实施方案中,内部护罩可以呈多个牵开器刀片中的一个牵开器刀片的形式。
在管状实施方案中,较小的管可以与较大的管同心,也可以不与其同心。在图5中,内部护罩的第一基本上管状部分和第二基本上管状部分是同心的(a=b)。在图6中,内部护罩的第一基本上管状部分和第二基本上管状部分是不同心的(a>b)。
在一些实施方案中,在较大和较小管之间提供球形接头,从而允许两个管之间的角度发生变化(图7)。在图7中,内部护罩的外表面23基本上嵌套在外部护罩的内表面10内,使得内部护罩的基本上管状部分的近侧端部终止于外部护罩内。而且,内部护罩的远侧端部部分朝远侧变窄以限定第一半径R1,并且内部护罩的近侧端部部分朝远侧变窄以限定第二半径,并且内部护罩的近侧端部部分嵌套在外部护罩的远侧端部部分内以实现内部护罩的多轴枢转。
在一些实施方案中,内部护罩是部分包围的管/护罩或“凸缘”,仅被设计用于保护神经。对于一些应用,内管的唯一目的可能是防护/保护穿出神经根。在这种情况下,内部护罩可能被简化为圆柱体,该圆柱体具有从其朝远侧延伸的凸缘25,使得凸缘仅仅是为整个圆的大约四分之一的护罩。参看图8a,或如果安装在外部护罩上,则参看图9。
神经保护器的深度调整
可以通过依赖于在外部护罩与内部护罩之间在沿外部护罩或内部护罩的任何位置处的干扰的机构来将前述外部护罩以其深度定位并固定。
在图8b中,内部护罩的第一基本上管状部分13的近侧端部部分包括适于邻接外部护罩的近侧端部部分的止挡件31,该止挡件适于防止内部护罩的过度远侧移动。优选地,止挡件基本上径向地围绕内部护罩的基本上管状部分的近侧端部部分延伸。止挡件还可以进一步包括适于抓紧的纹理化径向表面33。该纹理化径向表面既充当止挡件,又充当用于扭转护罩的柄部。
在图9中,内部护罩的外表面基本上嵌套在外部护罩的内表面内,使得内部护罩的基本上管状部分的近侧端部部分朝近侧延伸经过外部护罩的近侧端部。而且在图9中,外部护罩的外表面进一步包括适于连接到导航器械或稳定点的第一端口41,以及适于连接到摄像头/灯系统的第二端口 43。
外部护罩的导航:
第一个端口允许对外部护罩进行导航以确定其相对于治疗部位的位置 (深度和取向)。在一个实施方案中,外部护罩的外表面具有允许直接或间接附接导航器械的特征。在另一个实施方案中,外部护罩的内表面具有允许直接或间接附接导航器械的特征。
外部护罩中的内窥镜:
在一些实施方案中,外部护罩具有整体式内窥镜,该内窥镜可以相对于解剖结构设置在固定的或可变的(角度或周向)位置。这种内窥镜可视化可以用于随后的手术步骤,包括骨移除、内部护罩部署、椎间盘切除术和植入物插入。优选地,内窥镜具有用于原位自动清洁透镜的整体式透镜清洁机构。
图10公开了外管的横截面,其中外管壁138具有适于包含摄像头的第一通道238和适于包含透镜清洁装置的第二通道338。
图11公开了外管的横截面,其中外管壁包含透镜洁装置139和摄像头 239。
图12公开了顶端芯片实施方案,包括外管的横截面,其中外管壁具有包含内窥镜240的通道140,该内窥镜在其远侧端部附近具有视频芯片 340。
图13公开了外管的远侧端部,该外管以其远侧端部附近的视频芯片 141为特征。
固定式内窥镜:
该内窥镜可以是具有小于5mm的外径并且具有与外部护罩的长度基本上匹配的增量长度的顶端芯片型内窥镜。整体式顶端芯片内窥镜/外部护罩实施方案的益处包括在外部护罩的孔内具有相对自由空间,从而增强可视化。
优选地,内窥镜在端口内成角度或具有内置透镜角度,使得在端口内最终定位时,外部护罩的远侧部分的圆周是可见的,并且圆周内的区域也是可见的。
在一些实施方案中,可以从外部护罩的壁上移除内窥镜并且将其独立地插入到外部护罩孔中以检查治疗部位(例如,插入椎间盘间隙中以确认适当椎间盘切除术的进行)。
图14公开了用于内窥镜237的持镜器137。
仍然参见图9,在一些实施方案中,内部护罩的凸缘25具有弓形横截面。在一些实施方案中,凸缘的弓形横截面限定凸缘的外表面47,该外表面的曲率与外部护罩的内表面10的曲率基本上类似。优选地,凸缘限定第二基本上管状部分,该第二基本上管状部分的直径小于或等于内部护罩的第一基本上管状部分的直径。
现在参见图15a至图15b和图16,内部护罩可以是可以被安装到/钩挂到外管的单个刀片。在这种情况下,弯管51用作止挡件并且也用作外管的连接器。另外,内部护罩的近侧端部可以形成锚固销钉53。
存在许多方法来将内部护罩固定或定位到椎间盘上和/或外部护罩上。在一个实施方案中,这提供了内部护罩的针对滑移/脱位的安全性,包括将内部护罩朝远侧安装(到椎骨终板或椎间盘纤维环之上或之内)和/或朝近侧安装(到外部护罩之上)。
内部护罩与解剖结构的远侧固定可以包括:a)椎间盘纤维环内的固定,b)抵靠椎骨的固定;c)抵靠其他结构的固定;d)基尔希纳钢丝,该基尔希纳钢丝朝远侧延伸穿过内部护罩的壁并锚固到解剖结构;以及e)销钉,该销钉使远侧部分(图15)延伸以锚固到解剖结构。
内部护罩在外部护罩上的近侧固定可以涉及定位环或深度调整。现在参见图17,内部护罩在外部护罩上的近侧固定可以涉及定位环55。假设外部护罩相对于解剖结构固定,则可以选择在外侧具有外管形状以及在内侧具有内管形状的定位环。当放置在内部护罩上并进入外部护罩时,这种环将使近侧内部护罩相对于外部护罩以及相对于解剖结构(考虑到以上假设)的位置或至少取向稳定。
现在参见图18,内部护罩在外部护罩上的近侧固定可以涉及深度调整装置57。这另外通过将内部护罩经由棘轮系统锚固或钩挂到外部护罩中来使内部护罩相对于解剖结构的顶端位置稳定或锚固。棘轮系统也可以定位在外部护罩的内表面与内部护罩的外表面之间或定位在外部护罩的壁内。棘轮系统还可以包括弹簧系统以增加内部护罩与外部护罩之间的摩擦。
内部护罩部署(周向):
实施方案,其具有分开的外部护罩和内部护罩,允许内部护罩相对于外部护罩的独立定位。而且,较小的内部护罩(相对于外部护罩)的使用允许在不存在牵开敏感组织的入口处实现最大程度的可视化。这种最大程度的可视化实现了内部护罩的准确放置。在外部护罩的远侧存在牵开敏感组织的情况下,相对较小的内部护罩允许实现最小程度的牵开,同时提供穿过或经过这些组织的通路。优选地,内部护罩的内径不超过外部护罩的内径的40%至100%。
在一些实施方案中,将内部护罩-外部护罩构型替换为:a)初级护罩,该初级护罩具有基本上管状形状,该基本上管状形状具有切出件;以及b)次级护罩,该次级护罩具有基本上可插入切出件中的形状。优选地,初级护罩具有基本上环形形状并且次级护罩具有与初级护罩的环形形状基本上匹配的弓形横截面。该实施方案允许次级护罩相对于初级护罩倾斜。
内部护罩部署(径向):
在另一个神经保护实施方案中,护罩的牵开运动是径向的而不是旋转的。在这些实施方案中,可以使用直的内部护罩或卡口式内部护罩。内部护罩可以定位在受保护组织将被定位的区域上方。然后,凸缘护罩可以在外部护罩的远侧端部处倾斜(例如,朝向尾椎弓根)进入进入窗口的中心。凸缘护罩随后可以纵向地进入神经根的内侧,形成Kambin所述的“安全区”。凸缘护罩随后成角度,使得内部护罩的远侧顶端侧向成角度,其中内部护罩的外部远侧表面将穿出神经根轻轻地推开和/或防护穿出神经根使其避开为进行椎间盘内手术而进一步向内侧引入到护罩的工具。该实施方案可以被构造成使得内部护罩基本上嵌套在:a)外部护罩的壁内(图19);b)外部护罩的内表面的内部(图21);或c)外部护罩的外表面的外部。在一些实施方案中,内部护罩内置于外部护罩的壁内或甚至外部护罩的外部。
图19公开了整体式牵开器,该整体式牵开器具有容纳于外管245内的平坦内表面145。
图21公开了牵开器,该牵开器具有容纳于外管内的平坦内表面144。
在其它实施例中,外管可具有与外管的外表面嵌套的牵开器。
神经保护器的深度控制:
可以通过依赖于在外部护罩与内部护罩之间在沿外部护罩或内部护罩的任何位置处的干扰的机构来将前述外部护罩以其深度进行控制。
有多种途径可以由本发明的装置使用来撑开椎间盘间隙和/或在安装时提供神经保护。
在一个牵开实施方案中,使用旋转展延器。这是一种常规的概念,涉及插入到椎间盘中的卵形或矩形横截面形状的棒,所述棒的较小维度指向椎骨终板。在力的作用下将展延器转动90°后,较大维度指向椎骨终板,这通过两个横截面尺寸的差将椎间盘撑开。
在第二牵开实施方案中,如现在参见图22至图24b,内部护罩可以包括展延器,该展延器包括框架60、头部刀片61和尾部刀片63。
将在头部位置和尾部位置具有头部撑开刀片61和尾部撑开刀片63的展延器以塌陷/渐缩构型引入到椎间盘中(图22)。然后将展延器刀片用内芯65(该芯与刀片上的反作用几何形状匹配以免侧向滑脱)撑开,从而使椎间高度从d1升至d2(图22至图23)。然后将与内芯高度匹配的侧壁67 向内侧/向侧面引入(图24a),以周向地封闭四壁式护罩。一旦内芯被移除,堆叠式护罩使椎体保持以撑开状态分开(图24b)。
现在参见图25至图26,内部护罩可以进一步包括旋转凸缘71,该旋转凸缘在旋转时向侧面/向内侧移动以防护神经根。
在神经保护实施方案中,并且现在参见图27至图30,使用旋转漏斗 70。优选地,可以巧妙地引入凸缘护罩71以在插入时保护穿出神经根。如果通过外部护罩引入这个护罩,则这个护罩可以指向尾椎弓根。这个位置是“保存区”。一旦远侧顶端达到椎间盘水平,内部护罩就可以顺时针转动大约90°(即旋转),使得凸缘将穿出神经根轻轻地推开和/或防护穿出神经根使其避开为进行椎间盘内手术而进一步向内侧引入到护罩的工具。
在第二神经保护实施方案中,并且现在参见图31至图34,使用同心排列的多护罩来轻轻地移动和/或防护神经。旋转漏斗原理也可以应用于多于一个旋转护罩。如果只需要对位于单一侧的结构提供保护,则单个护罩可能是合适的。然而,在其他情况下,朝向椎间盘的护罩入口在内侧和侧面均受到穿出神经和下行神经的约束,因此内部护罩需要防护两个相对的结构。在这种情况下,两个同心地布置的外旋转凸缘81和内旋转凸缘83 在相应的顺时针和逆时针方向上转动90°以达到最终构型,其中相对的护罩保护神经使其避开为进行椎间盘内手术而进一步引入的工具。
在另一个神经保护实施方案中,径向牵开的多护罩用于轻轻地移动和/ 或防护神经。径向牵开原理也可以应用于多于一个径向牵开护罩。
图35公开了径向软组织牵开器136。
图36公开了外管/内部牵开器组件,其中第一内部牵开器153和第二内部牵开器253均向内倾斜以牵开软组织。
如果只需要对位于单一侧的结构提供保护,则单个护罩可能是合适的。然而,在其他情况下,进入椎间盘的护罩入口在内侧和侧面均受到穿出神经和下行神经的约束,使得内部护罩需要防护两个相对的结构。在这种情况下,两个相对的内凸缘初始朝向外管进入窗口的中心定位,并且随后向外牵开以防护相对的神经使其避开为进行椎间盘内手术而进一步引入的工具。
图37至图46公开了涉及套管式进入装置的优选外科手术方法。
在一个实施方案中,并且现在参见图37,外科医生放置基于椎弓根螺钉的锚固件,向锚固件添加导航参考框架101,并使用商用导航系统进行导航。在一些实施方案中,参照与治疗部位基本上对称地相邻的解剖学特征 (例如,对侧颅骨或尾椎弓根)来将导航阵列放置到解剖结构上。
在一些实施方案中,通过Kambin三角区将探头导航到小关节囊或椎间盘间隙。优选地,在切开筋膜和肌肉之后,引入启用了导航可视化的探头以获得初始锚固点。在一个实施方案中,将探头通过指向上关节突的外侧缘的外部而插入到椎间盘间隙中,并且可以任选地利用神经检测和/或可视化功能/在它们的支持下来启用。在另一个实施方案中,将探头引入到小关节囊中。
在一些实施方案中,在导航探头上存在扩张。在初始锚固点之后,执行扩张以针对进行治疗所需的端口大小来准备手术部位。然后执行顺序扩张直至获得优选大小的端口窗口。然后通过相关扩张器引入所述端口。在一个实施方案中,在椎间盘间隙中进行初始锚固并且将使用一个或多个同心顺序扩张装置以便围绕初始锚固点同心地牵开组织(在外侧使SAP的侧向部分,以及在内侧使Kambin三角区暴露)。在另一个实施方案中,在小关节囊内进行初始锚固并且可以使用一个或多个偏心顺序扩张装置以将组织牵开侧向地集中在SAP和Kambin三角区的侧向部分。
在一些实施方案中,将外部护罩固定到解剖学参考物上。外部护罩具有基本上管状部分,该管状部分具有被设计用于附接到稳定机构的点或特征,该稳定机构继而固定到治疗部位的头部或尾部的椎体上的解剖学特征。
图38公开了外管,进入其中的插塞包含用于引导骨切割装置的模板。
在一些实施方案中,外部套管附接到稳定机构。在一个实施方案中,这个稳定装置是一种具有足够的长度以在治疗部位的对侧上到达解剖学固定点(例如,椎弓根螺钉)的装置。所述机构(包括其连接到外部护罩和解剖学锚固件的连接特征)允许外部护罩的放置具有足够的灵活性,并且足够稳定以将外部护罩保持在适当位置,直到使用者松开为止。稳定方法使得使用者可以决定刚度。
在另一个实施方案中,这个装置具有足够的长度以在治疗部位的同侧上到达解剖学固定点(例如,椎弓根螺钉)。同样地,所述机构(包括其连接到外部护罩和解剖学锚固件的连接特征)将允许外部护罩的放置具有足够的灵活性,并且足够稳定以将外部护罩保持在适当位置,直到使用者松开为止。稳定方法使得使用者可以决定硬度。
在另一个实施方案中,这个装置是一种具有足够的长度以在患者的中线上到达解剖学固定点(例如,椎弓根螺钉)的装置。同样地,所述机构 (包括其连接到外部护罩和解剖学锚固件的连接特征)将允许外部护罩的放置具有足够的灵活性,并且足够稳定以将外部护罩保持在适当位置,除非使用者松开。稳定方法使得使用者可以决定硬度。
现在参见图39a至图39b,外科医生然后使组织扩张到超过基于椎弓根的锚固件,并插入连接至锚固件的外部护罩1,该外部护罩的近侧端部指向上关节突。在受到影响的椎间盘上进行一直到骨头的钝性分离,然后在受到影响的椎间盘上进行肌肉牵开。这种牵开涉及在直接可视化下对肌肉和筋膜到骨水平的钝性分离。
现在参见图40,外科医生然后将外部护罩1转向层间空间,根据病理需要执行中央双侧减压,然后将护罩转回其初始位置。
在一些实施方案中,从切口位点向内侧倾斜进入通道的替代形式可以是使用更为内侧的另选进入位点。在一些实施方案中,椎间盘空间中的初始锚固点将在下关节突的内侧。对于在小关节囊中具有初始锚固点的实施方案,偏心扩张器的扩张将从囊向内进行扩张。此外,将通过骨移除区段移除部分椎板和下关节突。
现在参见图41,外科医生然后将骨移除工具(未示出)插入外部护罩管并切除上关节突的侧向部分以向内延伸传统的Kambin三角形。
在直接或内窥镜式可视化下,骨移除装置被引入外部护罩并用于至少移除SAP的侧向部分。此类装置的长度和尺寸可供选择,从而允许通过 40mm至200mm的进入窗口和10至25mm的窗口尺寸进行安全引入和使用。
在一个实施方案中,骨移除装置是超声切割装置。在另一个实施方案中,骨移除装置是往复式切割表面。在又一个实施方案中,骨移除装置是旋转切割工具。在另一个实施方案中,骨移除装置是行程长度介于10mm 至30mm之间的机械冲头。可以以这样的方式移除骨,即将尺寸小于进入尺寸的骨切除并移除。可使用独立插入外部护罩中并用于引导骨切割和移除的方向的模板执行骨移除。
负模板是插入外部进入管中的插头式装置。根据需要被移除的组织的横截面形状,它包括不同形状的纵向切口,相应的组织的横截面形状需要被覆盖并由此免受任何外科手术相互作用。通过将例如铣刀的切割装置插入纵向切口中,外科医生能够移除组织而不会危及被覆盖的组织/结构。结合近侧止动系统(在外部进入管的近侧端部和/或铣削系统的轴上),外科医生可逐层移除组织。层的厚度以及由此的切割程序的进展可通过标尺支持的止动系统进行控制。该系统允许外科医生利用受控的连续工作流程执行安全的组织移除:检查解剖情况→调节止动系统以限定需要被移除的组织的横截面厚度→在止动系统接合之前插入铣削系统→在平面(2D)上(也是盲目地)铣削/切割组织→移除铣削系统→检查解剖情况→调节止动系统。
可以认为连续的工作流程比并行工作流程更安全,因为外科医生一次只需关注一个参数(此处为:铣刀的平面位置,然后是铣刀的深度,然后是铣刀的平面位置......),但是并行工作流程需要一次控制两个或更多个参数(此处为:铣刀的平面位置与其深度)。
SAP移除的导航可利用上述骨移除装置进行,该骨移除装置适于通过其与导航系统的机械或视觉连接来导航。
现在参见图42至图43,外科医生然后将内部护罩管插入外部护罩管中,该内部护罩用于将外管从小关节线向前延伸,直到内部护罩的末端达到椎间盘的水平面。神经根由内部护罩保护。
现在参见图44,外科医生然后识别椎间盘,并利用楔形骨凿展开椎间盘;检查松动,并移除后缘、骨刺和环带,直到打开最小的环形窗口。外科医生然后将椎间盘移除工具201插入进入装置中,移除椎间盘并准备终板。
图44中规定的椎间盘清理步骤的另选实施方案是将椎间盘移除工具通过其与导航系统的机械或视觉连接进行导航。
现在参见图45,外科医生然后执行暂时的椎间盘空间牵张,用骨移植物填充椎间盘空间的一部分,并将融合笼203插入剩余的椎间盘空间中。
现在参见图46,外科医生然后加入后部固定103。
观察元件
在一些实施方案中,使用了基于芯片在末端上的技术并被集成到端口的壁中的可视化元件。该实施方案与安装在管壁处的标准棒状透镜内窥镜相比具有许多优点:
·制造成本。芯片在末端上的技术允许非常有成本效率的制造,因此可作为“一次性”器械销售。
·刚性部分仅在远侧末端处。尽管标准的棒状透镜内窥镜系统在整个管上具有刚性的圆柱形状,但是芯片在末端上的内窥镜在近侧外管端部可具有非圆柱形构造。优选地,该形状是扁平缆线形状。在一些新颖的实施方案中,相对于标准棒状透镜内窥镜,芯片在末端上的内窥镜具有相对较短的“刚性”节段(约20mm),其中近侧端部包括可以是柔性的缆线。在其他实施方案中,刚性部分较短(产生较小的芯片组件)并且主动进行关节运动的概念用于改变透镜角度。由于缆线集成在管壁中,端口窗口的形状在整个程序中得以保持。例如,5mm芯片在末端上的内窥镜将15mm的圆形进入窗口变成肾状进入窗口。
·相机单元的尺寸/重量。标准的棒状透镜内窥镜具有标准目镜,该目镜是具有一定尺寸的通用接口。连接到此类系统的相机必须内置于一定的尺寸中以与目镜兼容。这个要求产生了具有诸多缺点的相对笨重的相机附件(直径为约3至6cm,长度为约5至10cm)。首先,这个较大的相机构造可能是工作中的物理障碍,特别是当工作端口的轨迹改变或干扰相机时。其次,这种常规构造的尺寸和重量变得足够大,以致在棒状透镜内窥镜上产生某些不希望的力,特别是在弯曲时。第三,相对脆弱的常规棒状透镜内窥镜必须嵌入诸如金属管的稳定结构中,从而进一步减少活动工作窗口。
利用本文所公开的芯片在末端上的实施方案,其芯片缆线嵌入在外管的壁中,在近侧外管壁处离开的缆线不会在工作端口上产生类似的力。此外,就将芯片在末端上的内窥镜安装在管壁中的附接机构而言,由于没有产生弯曲力从而提高了采用机械上不必非常稳定的相对较薄的附接选项的可能性。
·工作环境。通常,在脊柱内窥镜检查应用中使用恒定的流体环境 (盐水溶液的持续流动)。然而,在小切口和显微手术环境中,由于解剖条件差异很大,因此流体环境没有帮助。因此,在本文所述的优选新颖程序中,芯片在末端上的内窥镜在干燥的开放空气环境中工作。然而,芯片在末端上的内窥镜在其中所使用的开放的干燥空气环境可能对内窥镜的透镜部件产生不希望的凝结效应。例如,较冷的透镜在潮湿的体温环境中可能会起雾。此外,来自单极解剖刀或止血工具的钻屑、毛刺碎片或烟雾同样会影响内窥镜的透镜从而降低可视性。因此,期望周期性地清洁芯片在末端上的内窥镜的透镜。
神经偏转(管中管)
在通过门静脉进行的微创脊柱手术中,经常使用一组扩张器来准备接收门静脉的位点。美国专利公开US 2012-0232552(Morgenstern)中示出了一种此类技术。在这种常规技术(其具有偏心扩张器)中,任何一个扩张器的外径与下一个连续的(外部)扩张器的内径相同。这种直径的同一性对于荧光镜透视检查辅助的经皮肌肉扩张是必需的。
由于本申请的一些实施方案描述了在脊柱关节的水平面与椎间盘之间的程序,所以在直接可视化下解剖手术位点。因此,在这些新颖的程序中使用的连续扩张器的直径不必匹配。这些新颖的程序中宽松的“精确直径”要求允许外科医生在许多管设计区域中更加自由。例如,它允许使用锥形管。它还允许外科医生自由使用不同轴的外部端口和内部端口。它进一步允许内部端口相对于外部端口的轨迹在某些治疗步骤中在角度上发生变化。最后,它允许内部端口相对于外部端口的轨迹在某些治疗步骤中在距离上发生变化。
由于荧光镜透视检查辅助,经皮肌肉扩张在没有直接可视化下进行,因此这是使用具有限制的盲目的程序。这些限制包括无法进行出于安全考虑而需要直接可视化的手术步骤。需要直接可视化的一个此类治疗步骤是对骨和与神经结构直接相邻的韧带组织进行直接减压。由于这种减压是在脊柱融合期间对退化的脊柱动作区段执行的常见步骤,因此Morgenstem程序严重限制了可被治疗的病理/适应症。
由于本文所述的一些实施方案允许对解剖结构直接可视化,所以这些实施方案进一步特别地允许对骨和与神经结构直接相邻的韧带组织进行直接减压,并且更一般地允许通过完全保留组织的“管中管”入口对与管相邻的组织进行操作或移除。
Morgenstem还描述了一种方法,在该方法中,在荧光镜透视检查的引导下(即,无直接可视化),通过椎间盘空间将导丝直接引入Kambin三角形。这是一种众所周知的方法,但仍然需要在没有直接可视化的情况下将导丝插入穿过神经结构。Morgenstern还描述了使用基于电的神经监测探头的可能性。此外,Morgenstern描述了一种通过随后从SAP和椎弓根中锉掉骨的扩大棘突的方法。这种程序可能会削弱椎弓根的基部,这使得将该方法与椎弓根螺钉结构结合起来存在风险。
本文所述的新颖程序仅在小关节线上方的安全区域中执行非可视化程序(例如,扩张)。在解剖学上更为关键的小关节水平面与椎间盘之间的区域中,该新颖的程序在直接可视化下解剖手术位点,从而允许外科医生尽可能多且尽可能有意义地留出骨。
导航
通过术中实时显示,导航增强了静态X射线、CT或MRI数据,其中实际使用的器械与患者的解剖结构相关。因此,它通过显示它们的形状、轨迹和定位甚至更重要的是它支持外科医生在执行操作期间保持器械取向来增加这些器械的安全性。
不希望受理论束缚,据信,微创技术不常使用的一个原因是与小切口技术相比,需要明显更高的X射线暴露来保持取向,其中外科医生仍然具有直接可视化所以实际上可以利用显微镜或小型放大镜看到活动位点。对于经常接触辐射的外科医生而言,X射线暴露的效果更强。这个挑战通过本文所述的新颖程序中实现的导航技术来解决,因为它们允许将X射线暴露减少到用于对准目的的理想的最小总共两个X射线。一旦单次侧向拍摄和单次前后拍摄已被对准,所有使用的器械(例如,Jamshidi针、指示器、扩张器、进入管、骨凿、可伸展保持架本身、椎间盘移除装置......)都可以实时投影到这些静态荧光图像中。另一个积极效果是可以节省大量时间。使导航系统就位也有助于外科医生了解内窥镜的取向(轨迹和深度),并因此了解他或她利用相机实际上看到的内容。这可以通过直接导航相机或通过将相机设置在集成到导航进入管中的固定位置中来间接实现。
Jamshidi针、指示器、扩张器和进入管器械都可以使用一个器械,即 FOX导航多功能工具进行导航。
图47a至图47c公开了一种导航插头,该导航插头包括基座147,该基座具有与其连接的阵列247,其中该插头适于配合在外管347内。
骨切割器
在一些实施方案中,新颖的程序使用用于SAP移除的超声骨切割装置,该装置仅切割骨并且不会切割软组织。基于用于椎间体融合的常规可扩展笼式装置的实施方案可能需要至少与12mm一样大的进入窗口。这么大的窗口只能通过(部分)移除上关节突(SAP)以延伸Kambin三角形来实现。由于超声骨切割装置在意外碰到神经时不会切断神经而显着增加了此程序的安全性。如果切割装置刀片被设计成朝远侧达到椎间盘空间的水平面的内管/刀片的形状和直径(即,饼干切割器设计),则SAP移除可以被最小化(更少的创伤,对患者的压力更小,恢复更快)并且在单个步骤中执行(比多步骤程序更快)。
图48公开了从外管243的端部延伸的超声切割器的饼干切割器型远侧端部143,其中远侧端部143具有多个切割齿343。
另一种提高骨切割安全性的方法是利用负引导对骨进行深度控制的手动铣削。负引导涵盖那些不会被移除的区域(负模板)。深度控制允许在外科医生的连续控制下逐层铣削骨层。深度控制的参考以及轨迹可以是外部进入管(还可参见导航段落)。
图49a至图49b公开了用于引导骨切割装置的模板的各种横截面。
骨切割器
在一些实施方案中,骨移除装置是具有饼干切割器设计的超声刀。该解剖刀具有与外管接合的月牙形切割表面。该解剖刀被用作单程器械,一次性移除预定量的骨。在一些实施方案中,该解剖刀还具有喷洒水以用于冲洗的管,而外管具有用于清除已移除骨的浆液的抽吸管线。
在一些实施方案中,该解剖刀可以被导航并且骑在设置在外管内壁上的狭槽中。狭槽的深度可以预先确定,以提供深度控制的铣削并控制切割器的走向。这是有利的,因为据信徒手切割很容易碰到神经。切割表面的形状和尺寸可限定待移除的骨的特定区域。切割的特异性是有利的,因为它将骨的移除量降至最小,这对及其无力的小关节是有利的。因此,实现了更快的程序,更少的创伤(更少的疼痛)以及更稳定的结构。
观察元件(黄褐色)
在一些实施方案中:芯片观察元件可以成角度以便使其可以看到管的周围角落。
在常规的内窥镜中,可视化是2D的(即,没有深度感知),所以当两个神经实际相距2cm时,它们可能看起来紧密靠近。因此,在一些实施方案中,内窥镜被修改使得芯片起到测距仪的作用。具体地讲,芯片识别并评估距离芯片已知距离的参考结构,然后基于该评估测量神经距离芯片 (管端部)有多远。
神经偏转(管中管)
在一些实施方案中,外部护罩上具有压力传感器以测量神经上的压力。使用可以测量距离的超声技术,系统可以测量回缩时神经的伸长,并限定最大伸长极限(例如,20%),然后在超过伸长极限时向外科医生发出警告。在一些实施方案中,系统将超声集成到端口中并由此导航端口。
在一些实施方案中,外科医生导航相机。这允许外科医生了解相机的取向。
在一些实施方案中,可视化提供了椎间盘的轴向视图,因此外科医生可以了解椎间盘移除工具的位置。
神经监测分析
目前,神经监测装置可用于获得可能在手术环境中引起的潜在神经健康或神经损伤的指示。通过测量手术位点附近的神经与神经的远端之间的电脉冲来实现神经健康的这种指示。例如,可以在脊柱的神经根和腿上的某个点之间测量脉冲。
神经损伤可通过直接手动接触神经而引起。除了诸如切断或压碎神经的严重损伤之外,对神经施加其他较小的力也会造成损伤。例如,使神经移位,拉伸神经或压迫神经可导致严重的损伤。在一些情况下,将此类力扩展施加到神经可减少流经神经的血液,再次导致神经损伤。通常情况下,这个暴露时间取决于施加的力的量。因此,对于外科医生能够装载神经多长时间似乎没有已知的坚定规则。
除了神经监测之外,评估潜在神经损伤的替代形式可能为程序期间的神经保护带来新的见解。就这一点而言,神经操作测量可以产生对神经风险的指示。如果神经在程序期间发生移位,它可能会被拉长或者可能会发生侧向移位。可测量神经物理特征的这些改变并用于预测潜在的神经损伤。因此,可测量其他潜在特征并用于预测潜在的神经损伤,包括弧长和神经本身的直径等。这些特征可通过诸如超声的技术以可量化的术语测量。所得的测量值然后根据绝对值、百分比变化或一些其他指示可从数据库或文库中获得的潜在神经风险/损伤的度量(通过软件或手动)进行分析。在一些实施方案中,这些度量可用作安全时间长度的预测因子,在该安全时间长度内,神经可具有给定的移位或变形而不引起长期损伤。还可使用计算或算法来确定最大安全变形,或者神经可具有给定变形特征的最大许可时间。
这种测量可通过许多方式获得。它可以通过手动、光学或其他成像形式进行测量。这可以发生开腹手术、MIS中的皮下注射或其他类型的程序。直接可视化可使用相机完成。之前和之后的图像可被解释为计算绝对变形量或百分比变化量。该测量可以通过诸如超声或可以“看见”软组织或识别与周围组织相关的神经组织的其他形式的成像(X射线、CAT/PET 扫描、MRI等)来获得。
根据该实施方案可以使用的其他测量方法可包括a)测量由于装载引起的神经内的密度变化,或者b)血流量的变化。此类测量可以通过雷达、超声和其他成像方法获得。
在一些神经监测实施方案中,测量神经或脉冲内的阻抗是可能的,其中这可以相对于神经的特定变形区域局部完成。具体地讲,在本文所讨论的一些实施方案中,神经护罩可以在护罩的相对边缘上具有传感器,该传感器将接触两个不同神经位置中的相同神经。这些传感器将允许外科医生在神经扩张之前读取诸如脉冲或阻力的电气值,然后在发生扩张或实现扩张时再次测量电气值。这些测量值的差值可以是变形程度的指标。
图50公开了具有半圆形切割件切割器骨的超声波切割器的饼干切割器型远侧端部142。
图51公开了连接外管246和螺钉伸出部346的小型挠曲臂146。
图52公开了外管/内部牵开器组件,其中内部牵开器151向内倾斜以牵引软组织。
图53公开了外管/内部牵开器组件,其中内部牵开器152平行于外管 252延伸。
图54公开了容纳在外管内的内窥镜154和从外管延伸的内管254。
在上文所公开的许多实施方案中,内部护罩嵌套在外部护罩内。然而,在所有这些实施方案的另选实施方案中,内部护罩被集成到形成在外部护罩的壁内的切口中的可移除刀片代替。在这种情况下,内部护罩的外表面基本上嵌套在外部护罩的外表面内,使得凸缘朝远侧延伸经过外部护罩的远侧端部。
在上文所公开的许多实施方案中,内部护罩的基本上管状的部分的近侧端部包括适于抵靠外部护罩的近侧端部的止动件,所述止动件适于防止内部护罩的过度远侧运动。在其他实施方案中,支座发生在沿着外部护罩的任何地方。
Claims (15)
1.一种用于进入椎间盘的进入装置,包括:
a) 外部护罩,所述外部护罩具有基本上管状的部分、适于从切口延伸到关节突的长度、近侧端部部分、远侧端部部分、外表面以及限定内表面的纵向通孔,
b) 内部护罩,所述内部护罩具有近侧端部部分、远侧端部部分、内表面以及外表面,和,
c) 设置在所述外部护罩的远侧端部部分中的视频芯片,
其中所述内部护罩基本上嵌套在所述外部护罩内,使得所述内部护罩朝远侧延伸经过所述外部护罩的所述远侧端部部分,以及
其中所述视频芯片设置在所述外部护罩的通道中,且所述通道至少在所述外部护罩的远侧端部部分处通向所述外部护罩的内表面。
2.根据权利要求1所述的装置,其特征在于,所述内部护罩的所述近侧端部部分包括适于邻接所述外部护罩的所述近侧端部部分的止动件,所述止动件适于防止所述内部护罩的过度远侧运动。
3.根据权利要求2所述的装置,其特征在于,所述止动件从所述内部护罩的所述近侧端部部分基本上径向地延伸。
4.根据权利要求3所述的装置,其特征在于,所述止动件还包括适于抓紧的纹理化径向表面。
5.根据权利要求1所述的装置,其特征在于,所述内部护罩的远侧端部部分具有弓形横截面。
6.根据权利要求1所述的装置,其特征在于,所述内部护罩的远侧端部部分的所述弓形横截面限定所述内部护罩的外表面,所述外表面具有基本上类似于所述外部护罩的所述内表面的曲率的曲率。
7.根据权利要求1所述的装置,其特征在于,所述内部护罩的所述外表面基本上嵌套在所述外部护罩的所述内表面内,使得所述内部护罩的所述近侧端部终止于所述外部护罩内。
8.根据权利要求1所述的装置,其特征在于,所述外部护罩的所述外表面还包括适于连接到导航器械的第一端口。
9.根据权利要求8所述的装置,其特征在于,还包括:
- 所述导航器械,其中所述第一端口连接到所述导航器械。
10.根据权利要求1所述的装置,其特征在于,所述外部护罩的所述外表面还包括适于连接到光源的第二端口。
11.根据权利要求1所述的装置,其特征在于,所述内部护罩具有作为止动件起作用的近侧弯管。
12.根据权利要求1所述的装置,其特征在于,所述内部护罩具有作为锚定件起作用的尖锐远侧末端。
13.根据权利要求1所述的装置,其特征在于,还包括:d)定位在所述护罩的所述近侧端部之间的定位环,其中所述环适于将所述内部护罩朝近侧固定在所述外部护罩上。
14.根据权利要求1所述的装置,其特征在于,所述通道在所述外部护罩的远侧端部沿所述外部护罩的远侧端部部分与所述外部护罩的纵向通孔相交。
15.根据权利要求1所述的装置,其特征在于,还包括扁平缆线,其联接到所述视频芯片且从所述外部护罩的近侧端部部分延伸。
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US11559328B2 (en) | 2023-01-24 |
US20230135764A1 (en) | 2023-05-04 |
JP2021007812A (ja) | 2021-01-28 |
US20190209154A1 (en) | 2019-07-11 |
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