CN115426983A - 可扩张植入物组件 - Google Patents
可扩张植入物组件 Download PDFInfo
- Publication number
- CN115426983A CN115426983A CN202180027327.6A CN202180027327A CN115426983A CN 115426983 A CN115426983 A CN 115426983A CN 202180027327 A CN202180027327 A CN 202180027327A CN 115426983 A CN115426983 A CN 115426983A
- Authority
- CN
- China
- Prior art keywords
- control
- control shaft
- base member
- implant
- adjustable member
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
- A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
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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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- 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
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- 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
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- 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
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- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
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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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/0009—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting thickness
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Abstract
公开了一种可扩张植入物。所述可扩张植入物包含:基座构件,所述基座构件具有顶表面和与所述顶表面相对的底表面;以及可调节构件,所述可调节构件可调节地耦合到所述基座构件,并且能在第一折叠位置与第二扩张位置之间移动。所述可调节构件具有顶表面和与所述顶表面相对的底表面。当所述可调节构件处于所述第一折叠位置时,所述可调节构件的所述顶表面和所述基座构件的所述底表面形成第一角度,并且当所述可调节构件处于所述第二扩张位置时,所述可调节构件的所述顶表面和所述基座构件的所述底表面形成第二角度。所述第一角度不同于所述第二角度。
Description
本申请要求2020年4月16日提交的美国申请第16/850,795号的优先权和权益,并且是所述美国申请的延续,所述美国申请以全文引用的方式并入本文中。
背景技术
本公开涉及可扩张植入物和装置,包含脊柱椎体间和椎骨内装置,以及在放置于脊柱处后可扩张的椎体间或椎骨内装置。
许多人因年龄、疾病、创伤以及先天性和后天性并发症和病症而面临脊柱问题。虽然这些问题中有一些不需要手术就能缓解,但其它问题则必需手术。对于脊柱滑脱、椎间盘退变性疾病或椎间盘突出复发等病症,可推荐脊柱融合术,其目的是在相邻椎骨之间形成坚固的骨骼,从而消除骨骼之间的任何移动。脊柱融合术使用被称为椎体间融合器或间隔物的植入物或装置,以及从脊柱一侧插入相邻椎骨之间的椎间隙的骨移植物和/或骨移植物替代物。通常,例如椎弓根螺钉和杆或板的额外外科硬件(植入物)附接到椎骨背面。当骨移植物愈合时,其融合相邻的椎骨以形成一个长椎骨。
融合器以及其它类型的植入物、植入体和/或装置经常用于患者的椎骨内部(椎骨内)和/或椎骨之间(椎体间)或相邻的其它骨体的脊柱手术。借助于椎体间装置,一个或多个此类椎体被放置在椎骨之间,以在相邻椎骨之间提供支撑并促进融合,这些相邻椎骨由于疾病、损伤、一般退化或先天性问题而需要这样做。利用椎骨内装置,将一个或多个椎体放置在椎骨内。例如融合器等脊柱装置向前、向后、侧向或后侧向插入脊柱空间。
发明内容
在一些实施例中,公开一种可扩张植入物。所述可扩张植入物包含:基座构件,所述基座构件具有顶表面和与所述顶表面相对的底表面;以及可调节构件,所述可调节构件可调节地耦合到所述基座构件,并且可在第一折叠位置与第二扩张位置之间移动。所述可调节构件具有顶表面和与所述顶表面相对的底表面。当所述可调节构件处于所述第一折叠位置时,所述可调节构件的所述顶表面和所述基座构件的所述底表面形成第一角度,并且当所述可调节构件处于所述第二扩张位置时,所述可调节构件的所述顶表面和所述基座构件的所述底表面形成第二角度。所述第一角度不同于所述第二角度。
在进一步的实施例中,公开一种可扩张植入物。所述可扩张植入物包含:基座构件,所述基座构件具有导槽;以及可调节构件,所述可调节构件可调节地耦合到所述基座构件,并且可在第一折叠位置与第二扩张位置之间移动,其中所述可调节构件具有导轨。所述导槽被配置成接收所述导轨,使得当所述可调节构件从所述第一折叠位置移动到所述第二扩张位置时,所述导轨在所述导槽内平移。所述导轨具有曲率,使得所述可调节构件以非线性方式从所述第一折叠位置移动到所述第二扩张位置。
在进一步的实施例中,公开一种可扩张植入物。所述可扩张植入物包含:多个锚固构件;基座构件,所述基座构件被配置成接收锚固构件;可调节构件,所述可调节构件耦合到所述基座构件并且可在第一折叠位置与第二扩张位置之间移动,其中所述可调节构件被配置成接收锚固构件;以及控制组件,所述控制组件包含控制轴。所述控制轴的旋转引起所述可调节构件相对于所述基座构件的相对运动。
附图说明
通过参考图示本文公开的主题的附图将更好地理解本文公开的主题的特征,其中:
图1是根据示例实施例的处于折叠位置的植入物的透视图。
图2是根据示例实施例的处于折叠位置的图1植入物的另一透视图。
图3是根据示例实施例的处于折叠位置的图1植入物的俯视图。
图4是根据示例实施例的处于折叠位置的图1植入物的前视图。
图5是根据示例实施例的处于扩张位置的图1植入物的透视图。
图6是根据示例实施例的处于扩张位置的图1植入物的另一透视图。
图7是根据示例实施例的处于扩张位置的图1植入物的另一透视图。
图8是根据示例实施例的处于扩张位置的图1植入物的后视图。
图9是根据示例实施例的图1植入物的分解图。
图10是根据示例实施例的图1植入物的可调节构件的透视图。
图11是根据示例实施例的图10可调节构件的另一透视图。
图12是根据示例实施例的图10可调节构件的底侧的透视图。
图13是根据示例实施例的图10可调节构件的底视图。
图14是根据示例实施例的图1植入物的控制轴和两个控制构件的透视图。
图15是根据示例实施例的图14控制轴的透视图。
图16是根据示例实施例的图1植入物的控制构件的透视图。
图17是根据示例实施例的图1植入物的控制构件的透视图。
图18是根据示例实施例的图1植入物的基座构件内的控制轴和控制构件的透视图。
图19是根据示例实施例的图1植入物的基座构件的透视图。
图20是根据示例实施例的图19基座构件的后透视图。
图21是根据另一示例实施例的植入物的透视图。
图22是根据示例实施例的图21植入物的透视图。
图23是根据示例实施例的图21植入物的侧视图。
图24是根据示例实施例的图21植入物的前视图。
图25是根据示例实施例的控制轴和凸轮螺钉的前视图。
图26是根据示例实施例的图21植入物的控制轴和凸轮螺钉的前视图。
图27A-B是根据示例实施例的控制机构的示意图。
在几个视图中,相应的附图标记表示相应的部分。虽然附图表示本公开的实施例,但附图不一定按比例绘制,某些特征可能被夸大,以便更好地说明和解释本公开的原理。本文阐述的示例绘示了若干实施例,但这些示例不应被解释为以任何方式限制本公开的范围。
具体实施方式
在转向详细示出某些示范性实施例的附图之前,应理解,本公开不限于说明书中阐述的或附图中示出的细节或方法。还应理解,本文使用的术语仅仅是出于描述的目的,而不应该被认为是限制性的。
本公开涉及可扩张和/或动态植入物。在示例实施例中,植入物可以是椎体间(相邻椎骨之间)、椎骨内(椎骨内部)和/或脊柱稳定装置,其可以用作也可以不用作椎体间融合器或装置、椎体间/椎骨内稳定装置等(例如,脊柱装置),用于在已变得不稳定或另外由于损伤、疾病等而受影响的椎骨或骨的其它部分之间或内部提供支撑、稳定和/或促进骨生长。具体地,本公开提供了可用于人体脊柱或其它区域的动态(可扩张和/或可扩张和可收缩)椎体间/椎体内装置的各种版本。
本文公开的各种实施例涉及可植入相邻骨体之间的可扩张植入物。例如,植入物可植入或插入邻近脊柱的上下椎骨的人类脊柱中。根据各种示例实施例,本文公开的植入物的部件可由任何合适的材料制成,包含各种金属、塑料、复合材料或其它合适的生物相容材料。在一些实施例中,本文公开的植入物的一个或多个部件可由相同的材料制成,而在其它实施例中,对于各种植入物的不同部件可使用不同材料。
现在参考图1-4,示出了根据示例实施例的可扩张植入物10。植入物10例如可用于脊柱椎体之间和/或椎体内。应理解,在一些实施例中,植入物10可用于除脊柱之外的身体其它部分,并且所有此类应用应理解为在本公开的范围内。
根据一些实施例,植入物10包含基座构件12和可调节地耦合到基座构件12的可调节构件14。植入物10可进一步包含由基座构件12接收的控制轴16,所述控制轴由穿过基座构件12的一部分的凸轮螺钉18保持。第一控制构件20和第二控制构件22被接收在控制轴16上并且可沿控制轴16移动以在如图1-4所示的折叠位置与如图5-8所示的扩张位置之间调节可调节构件14的位置。
如图18所示,基座构件12包含前端或第一端24、后端或第二端26以及设置在第一端24与第二端26之间的中心腔36。基座构件12进一步包含具有由相应凹槽形成的脊或突起30的底表面28、与底表面28相对的顶表面32、第一侧38以及第二侧40。突起30被配置成接合骨的相邻部分。在一些实施例中,前端24包含被配置成接收保持销19的第一销孔42和被配置成接收保持销19的第二销孔43。在一些实施例中,第一侧38包含第三销孔,并且第二侧40包含被配置成接收保持销19的第四销孔45。在一些实施例中,例如,图1所示的实施例,第一侧38不包含第三销孔。第一销孔42、第二销孔43、第三销孔和第四销孔45可以被配置成单独地接收保持销19(例如,以压力配合或其它保持方式)。基座构件12的第一端24包含被配置成接收控制轴16的第一部分的控制孔48(见图9)。第二端26包含被配置成接收控制轴16的头部90的尖端孔50(见图7)。
在进一步的实施例中,基座构件12包含图20所示的第一支撑销孔27和图19所示的第二支撑销孔29。第一支撑销孔27和第二支撑销孔29可单独地被配置成接收支撑销17(例如,以压配合或其它保持方式)。支撑销17可以延伸到中心腔36中,并且可以支撑控制轴16,使得控制轴16将不会抵靠基座构件12的顶表面32触底。
在进一步的实施例中,基座构件12可包含第一前导槽52、第二前导槽53、第一后导槽54和第二后导槽55。第一前导槽52、第二前导槽53、第一后导槽54和第二后导槽55可用于定制植入物10的扩张轮廓,如将进一步详细讨论。
在一些实施例中,如图11和12所示,可调节构件14包含前端或第一端62、后端或第二端64以及位于第一端62与第二端部64之间的中心凹口或腔69。可调节构件14进一步包含顶表面66和底表面67,所述顶表面具有由相应凹槽形成的脊或突起68。可调节构件14还包含第一侧部86和第二侧部88。在一些实施例中,第一侧部86和第二侧部88具有大体上对应于基座构件12的第一侧38和第二侧40的形状。在其它实施例中,第一侧部86和第二侧部88具有不同于基座构件12的第一侧38和第二侧40的形状。
如图5所示,在进一步的实施例中,可调节构件14可包含第一前导轨78、第二前导轨79、第一后导轨80和第二后导轨81。在一些实施例中,第一前导轨78被配置成由第一前导槽52接收,第二前导轨79被配置成由第二前导槽53接收,第一后导轨80被配置成由第一后导槽54接收,并且第二后导轨81被配置成由第二后导槽55接收。根据示例实施例,当植入物10扩张时(例如,可调节构件14在远离基座构件12的方向上移动),导轨78、79、80、81将在每个相应导槽52、53、54、55内单独平移。
在进一步的实施例中,如图10所示的实施例,第一前导轨78可包含被配置成接收保持销19的第一销槽82。此外,第二前导轨79可包含被配置成接收保持销19的第二销槽83。此外,第一后导轨80可包含被配置成接收保持销19的第三销槽。在一些实施例中,例如图1所示的实施例,第一导轨80不包含第三销槽。此外,第二后导轨81可包含被配置成接收保持销19的第四销槽84。
参考图10-13,在一些实施例中,可调节构件14包含一个或多个控制通道,例如第一控制通道74和第二控制通道76。第一控制通道74接收第一控制构件20,并且第二控制通道76接收第二控制构件22。在一些实施例中,控制构件20、22以滑动方式接收在控制通道74、76中,使得控制构件20和22能够在控制通道74、76内平移。在进一步的实施例中,每个控制通道具有这样的形状,即控制通道围绕控制构件并且在形状上至少部分地对应于控制构件。
参考图14和15,控制轴16包含头部90、设置在头部90内的工具端口92以及位于与头部90相对的端处的尖端98。在一些实施例中,尖端98是平坦的,而在其它实施例中,尖端98可以是尖的或倾斜的。在一些实施例中,控制轴16进一步包含第一控制螺纹94和第二控制螺纹96。无螺纹部分100可以位于第一控制螺纹94与第二控制螺纹96之间。
如图16所示,第一控制构件20包含顶部220、一个或多个平坦部104以及内螺纹106。在一些示例实施例中,第一控制构件20被配置成由第一控制通道74接收,使得平坦部104与第一控制通道74的壁接合。
如图17所示,第二控制构件22包含顶部220、一个或多个平坦部111以及内螺纹212。在一些示例实施例中,第二控制构件22被配置成由第二控制通道76接收,使得平坦部111与第二控制通道76的壁接合。在一些示例实施例中,第一控制构件20和第二控制构件22沿控制轴16并且在第一控制通道74与第二控制器通道76内或之上移动或平移。
返回参考图1-8,在一些实施例中,植入物10可在至少如图1-4所示的第一折叠位置与如图5-8所示的第二扩张位置之间移动。在第一位置,控制轴16由控制孔48接收并且定位在基座构件12的中心腔36内。在一些实施例中,当植入物10处于折叠位置时,基座构件12的第一侧38和第二侧40接收可调节构件的第一侧86和第二侧88,使得突起和凹口具有相对紧密的配合,以实现可调节构件14与基座构件12之间的正确对准,如图1-4所示。在其它实施例中,突起和凹口具有相对宽松的配合,以实现可调节构件14与基座构件12之间的期望角度偏移。
在一些实施例中,控制轴16由基座构件12接收,使得头部90位于控制孔48内(见图9),第一控制螺纹94和第二控制螺纹96位于中心腔36内,并且头部90位于基座构件12的第二端26的尖端孔50内。在一些实施例中,控制轴16可在基座构件12内旋转。第一控制构件20接收在控制轴16的第一控制螺纹94上,并且第二控制构件22接收在控制轴16的第二控制螺纹96上。
在一些实施例中,如图14所示的实施例,第一控制螺纹94和第二控制螺纹96以相反的方式(例如,左手和右手)带螺纹,使得在控制轴16旋转时,控制构件20、22沿控制轴16在相反方向上移动。例如,控制轴16可以被配置成使得控制轴16在第一方向(例如,顺时针)上的旋转引起第一控制构件20和第二控制构件22朝向彼此移动,并且控制轴16在第二方向(例如,逆时针)上的旋转引起第一控制构件20和第二控制构件22远离彼此移动。
当控制构件20、22沿控制轴16移动时,控制构件20、22在控制通道74、76内进一步移动,从而引起可调节构件14和基座构件12的相对运动。当控制构件20、22沿控制轴16平移时,可调节构件14由于第一控制通道74和第二控制通道76的成角度形状而向上或向下移动。假设控制轴16的转动速率恒定,则可以通过修改控制通道74、76相对于控制轴16的斜率来调节控制构件20、22以及因此可调节构件14的移动速率。
例如,参考图27A-C,示出了根据各种替代实施例的控制轴16、第一控制通道74和第二控制通道76的示意图。第一控制通道74相对于控制轴16以第一角度116延伸,并且第二控制通道76相对于控制轴16以第二角度118延伸。第一角度116和第二角度118限定第一控制构件20和第二控制构件22引起可调节构件14的第一端62和第二端64相对于基座构件12的相应移动(例如,扩张)的速率。如图27A所示,在一些实施例中,第一角度116和第二角度118大致相同,并且控制通道74、76限定线性路径,使得可调节构件14的第一端62和第二端64的移动速率基本相同且恒定(假设控制轴16的旋转速率恒定)。如图27B所示,在一些实施例中,第一控制通道74和第二控制通道76可以平行方式延伸,或者被配置成在同一总体方向上以角度向上延伸,而不是在向上方向上彼此成角度。
为第一控制通道74和第二控制通道76提供不同的配置使得能够定制植入物10在第二扩张位置的特性。例如,控制通道74、76可以被配置成使得在植入物10的完全扩张位置,可调节构件14的第一端62和第二端64中的一端扩张到比另一端更大的程度。根据各种替代实施例,第一控制通道74和第二控制通道76的其它配置是可能的。
在进一步的实施例中,可以使用至少一个导轨进一步定制植入物10在第二扩张位置的特性。例如,根据图5-8所示的示例实施例的植入物10具有角扩张轮廓,其中可调节构件14的顶表面66和基座构件12的底表面28基本上不平行,而是形成角度。可调节构件14的顶表面66和基座构件12的底表面28在植入物10处于扩张位置时形成的角度可以基于患者的需要来定制。例如,当植入物10安装到患者的脊柱中时,可调节构件14的顶表面66和基座构件12的底表面28在植入物10处于扩张位置时形成的角度可以取决于植入物10安装位置处患者脊柱的曲率而变化。
根据示例实施例,可以使用至少一个导轨和至少一个控制构件来实现植入物10的角扩张轮廓。例如,在图5-8所示的示例实施例中,控制轴16由基座构件12接收,使得头部90位于控制孔48内,第一控制螺纹94和第二控制螺纹96位于中心腔36内,并且端部98位于基座构件12的第二端26的尖端孔50内(见图7)。在此实施例中,控制轴16可在基座构件12内旋转。第一控制构件20接收在控制轴16的第一控制螺纹94上,并且第二控制构件22接收在控制轴16的第二控制螺纹96上。
在此示例实施例中,第一控制螺纹94和第二控制螺纹96以相反的方式(例如,左手和右手)带螺纹,使得在控制轴16旋转时,控制构件20、22沿控制轴16在相反方向上移动。在此示例实施例中,控制轴16被配置成使得控制轴16在第一方向(例如,顺时针)上的旋转引起第一控制构件20和第二控制构件22朝向彼此移动,并且控制轴16在第二方向(例如,逆时针)上的旋转引起第一控制构件20和第二控制构件22远离彼此移动。
当控制构件20、22沿控制轴16移动时,控制构件20、22在控制通道74、76内进一步移动,从而引起可调节构件14和基座构件12的相对运动。当控制构件20、22沿控制轴16平移时,可调节构件14由于第一控制通道74和第二控制通道76的成角度形状而向上或向下移动。因此,可以通过修改控制通道74、76相对于控制轴16的斜率来调节控制构件20、22以及可调节构件14的移动速率。
当控制轴16在第二方向(例如,逆时针)上转动时,控制构件20、22沿控制轴16远离彼此平移。这样做时,控制构件20、22也在控制通道74、76内平移,从而引起可调节构件14大体上远离基座构件12移动。此外,当可调节构件14远离基座构件12移动时,导轨78、79、80、81分别在每个相应导槽52、53、54、55内平移。在一些实施例中,导轨78、79、80、81和导槽52、53、54、55可垂直于可调节构件14的顶表面66延伸,从而引起可调节构件14以线性方式向上移动。在这些示例实施例中,当植入物10处于第二扩张位置时,可调节构件14的顶表面66将基本上平行于基座构件12的底表面28。在其它实施例中,例如图5-8所示的实施例,导轨78、79、80、81和导槽52、53、54、55可以具有曲率。导轨78、79、80、81和导槽52、53、54、55的曲率将引起可调节构件14以非线性方式向上移动。因此,植入物10将具有角扩张轮廓(例如,可调节构件14的顶表面66和基座构件12的底表面28基本上不平行,而是形成角度)。
在一些实施例中,第一前导轨78可以具有比第二前导轨78更大的半径(例如,最接近该点处导轨曲线的圆弧半径),并且第一后导轨80可以比第二后导轨81具有更大的直径(例如,最接近该点处导轨曲线的圆弧半径)。
在进一步的实施例中,导轨可包含线性部和弯曲部,以允许植入物10在从折叠位置扩张到扩张位置的同时线性地且成角度地扩张。可以通过根据需要改变导轨和导槽的形状来进一步定制植入物10的扩张轮廓。
在进一步的实施例中,导轨可以是线性的。在此实施例中,可以通过改变销槽82、83、84的长度来实现角扩张轮廓。如下文进一步详细讨论,当将销19插入销孔42、43、45和销槽82、83、84中时,销19可抵靠销槽82、83、84的底部触底,从而防止植入物10过度扩张。如图10所示,在一些实施例中,第一销槽82长于第二销槽83。因此,当销19抵靠销槽82、83的底部触底时,例如图5所示的实施例,第一横向侧部86将比第二横向侧部88扩张更大的距离。因此,植入物可以包含在第一横向侧上具有销槽的线性导轨和在第二横向侧上的线性导轨。在此实施例中,如果第一横向侧上的销槽长于第二横向侧上的销槽,则第一横向侧将能够在销在销槽中触底之前比第二横向侧扩张更远的距离,从而形成角扩张轮廓。
在此示例实施例中,可以基于控制轴16在第二方向(例如,逆时针)上转动的弧度来定制角扩张轮廓。当控制轴16在第二方向(例如,逆时针)上转动时,可调节构件14的顶表面66与基座构件12的底表面28之间的角度大小将增大。因此,根据此示例实施例,当植入物10处于第二扩张位置时,控制轴16在第二方向(例如,逆时针)上转动的弧度数与植入物10的可调节构件14的顶表面66与基座构件12的底表面28之间的角度大小之间存在直接关系。
也可以通过改变导轨78、79、80、81的曲率和导槽52、53、54、55的曲率来定制可调节构件14的顶表面66与基座构件12的底表面28之间的角度大小。例如,调节导槽52、53、54、55的半径(例如,最接近该点处导槽曲线的圆弧半径)和导轨78、79、80、81的半径(例如,最接近该点处导轨曲线的圆弧半径)将引起植入物10的角扩张轮廓发生变化。例如,减小导槽52、53、54、55的半径(例如,最接近该点处导槽曲线的圆弧半径)和导轨78、79、80、81的半径(例如,最接近该点处导轨曲线的圆弧半径)将导致可调节构件14的顶表面66与基座构件12的底表面28之间的较大角度。因此,根据此示例实施例,当植入物10处于第二扩张位置时,导轨78、79、80、81的半径大小与植入物10的可调节构件14的顶表面66与基座构件12的底表面28之间的角度大小之间存在反向关系。
在示例实施例中,当植入物10以角度方式扩张时,如图5-8所示,控制轴16不必位于植入物10的中心。例如,如图3所示,当植入物10处于折叠位置时,尖端98位于尖端孔50的中心。然而,如图7所示,当植入物10处于扩张位置时,控制轴16的尖端98不再位于尖端孔50的中心,而是偏移。
在使用中,如图1所示,当处于第一折叠位置时,植入物10位于期望空间内(例如,在骨的相邻部分之间)。为了定位植入物10,可以使用适当的工具接合工具凹口56并将植入物10操纵到期望位置。一旦处于期望位置,可以使用后续工具来接合工具端口92并旋转控制轴16以将可调节构件14移动到期望扩张程度。应注意,基于特定应用,可调节构件14可用于完全折叠位置、完全扩张位置或其间的任何中间位置。一旦正确定位植入物10并扩张到期望高度,就可将骨移植物材料插入中心腔36中。在一些实施例中,基座构件12和可调节构件14中以及穿过它们的各种孔可促进植入物10内和周围的骨材料生长,以进一步稳定装置。
一旦植入物10位于期望空间内并扩张到期望扩张程度,就可以使用凸轮螺钉18固定控制轴16。凸轮螺钉18包含螺纹轴181和头部182,如图9所示。螺纹轴181允许凸轮螺钉18拧入基座构件12中。头部182包含工具端口184。工具端口184允许使用工具(例如六角头起子)拧紧或松开凸轮螺钉。虽然此示例实施例示出六角头工具端口184,但应理解,工具端口184可被设计成接收多种不同类型的手动工具,包含一字螺丝刀、十字头螺丝刀、艾伦扳手螺丝刀、六角起子、梅花起子、罗伯逊起子、三翼螺丝刀、艾伦带孔起子、梅花带孔起子、百事易十字槽螺丝刀、离合器起子、扳手、Schrader起子、螺母起子、六角扳手、节点带孔起子、所列起子接口的任何组合以及任何其它类型的起子接口。
头部182进一步包含平坦部186和凸轮部188,如图25和26所示。平坦部186包含头部182边缘处的平坦边缘,并且凸轮部188包含沿逆时针方向具有增大的半径(例如,最接近该点处导槽曲线的圆弧半径)的圆形边缘。
在示例实施例中,当植入物10处于折叠位置时,凸轮螺钉18的平坦部186可以靠近控制轴16,如图25所示。一旦植入物10位于期望空间内并扩张到期望扩张程度,就可通过转动凸轮螺钉18将控制轴16锁定到位。例如,可以拧紧凸轮螺钉18,使得凸轮部188接合并接触控制轴的头部90,如图26所示。这样做时,凸轮螺钉18的凸轮部188施加到控制轴16的头部90的力可以帮助防止控制轴16旋转,从而将控制轴16锁定到位。
在一些示例实施例中,凸轮螺钉18可进一步被配置成将控制轴16锁定到位。在一个示例中,在安装植入物10之后,植入物10可能容易过度扩张。在此示例中,当植入物10扩张时,如图26所示,控制轴16将在逆时针方向上转动。在此示例中,凸轮螺钉18可以使用右手配置进行螺纹连接,其中在顺时针方向转动凸轮螺钉18将凸轮螺钉18拧紧到植入物10的基座构件12中。在此示例中,凸轮部188与控制轴16的头部90接合。如果控制轴16开始在逆时针方向上旋转,则凸轮部188与头部90之间的摩擦将引起凸轮螺钉18(如图25所示)在顺时针方向上转动,进一步拧紧凸轮螺钉18,这将进一步将控制轴16锁定到位。
此外,在植入物10易于过度扩张的示例中,可以使用多个保持销19来防止过度扩张。例如,如图1所示,保持销19可以压力配合到第一销孔42中,从而延伸到第一销槽82中(见图10)。在此示例中,当植入物10处于完全扩张位置时,保持销19可抵靠第一销槽82的底部触底,从而防止植入物10进一步扩张。类似地,保持销19可以压力配合到第二销孔43中,从而延伸到第二销槽83中。在此示例中,当植入物10处于完全扩张位置时,保持销19可抵靠第二销槽83的底部触底,从而防止植入物10进一步扩张。此外,保持销19可以压力配合到第三销孔中,从而延伸到第三销槽中。在此示例中,当植入物10处于完全扩张位置时,保持销19可抵靠第三销槽的底部触底,从而防止植入物10进一步扩张。此外,保持销19可以压力配合到第四销孔45中,从而延伸到第四销槽84中。在此示例中,当植入物10处于完全扩张位置时,保持销19可抵靠第三销槽的底部触底,从而防止植入物10进一步扩张。
此外,可以通过改变销槽82、83、84的长度来进一步定制植入物10的扩张轮廓。如上文所论述,当销19插入销孔42、43、45并插入销槽82、83、84中时,销19可抵靠销槽82、83、84的底部触底,从而防止植入物10过度扩张。如图10所示,第一销槽82长于第二销槽83。因此,当销19抵靠销槽82、83的底部触底时,例如图5所示的实施例,第一横向侧部86将能够比第二横向侧部88扩张更大的距离。
在另一示例实施例中,在安装植入物10之后,植入物10可能容易折叠。在此示例中,当植入物10折叠时,如图25所示,控制轴16将在顺时针方向上转动。在此示例中,凸轮螺钉18可以使用左手配置进行螺纹连接,其中在逆时针方向上转动凸轮螺钉18会将凸轮螺钉18拧紧到植入物10的基座构件12中。此外,凸轮螺钉18将包含凸轮部188,所述凸轮部将在顺时针方向上增加半径(例如,最接近该点处导槽曲线的圆弧半径)。在此示例中,凸轮部188与控制轴16的头部90接合。如果控制轴16开始在顺时针方向上旋转,则凸轮部188与头部90之间的摩擦将引起凸轮螺钉18在逆时针方向上转动,从而进一步拧紧凸轮螺钉18,这将进一步将控制轴16锁定到位。
应注意,植入物10可以与本文描述的其它植入物共享各种特征,并且由相同、相似或不同的材料制成。例如,植入物10的各种部件可以由金属、塑料、复合材料或其它合适的生物相容材料制成。此外,植入物10可用于连接脊柱或身体的其它部分。
现在参考图21-23,在一些实施例中,植入物110的基座构件112和可调节构件114中的一个或两个可被配置成接收锚固构件,以进一步将植入物110固定到骨的相邻部分。在示例实施例中,锚固构件可以是骨螺钉150。例如,如图21和22所示,植入物110包含基座构件112和可调节地耦合到基座构件112的可调节构件114。控制轴216由基座构件112接收,并由穿过基座构件112的一部分的凸轮螺钉218保持。第一控制构件120和第二控制构件122接收在控制轴216上,并且可沿控制轴216移动,以在如图21所示的折叠位置与如图22和23所示的扩张位置之间调节可调节构件114的位置。骨螺钉150延伸穿过基座构件112和可调节构件114。
在一些实施例中,植入物110可以相对于其它植入物共享本文公开的特征的任何组合,并且所有这些特征的组合应理解为在本公开的范围内。在一些实施例中,除了本文所描述的,植入物110基本上类似于植入物10。在示例实施例中,基座构件112包含被配置成接收骨螺钉150的第一骨螺钉孔152。类似地,可调节构件114包含被配置成接收骨螺钉150的第二骨螺钉孔254。在一些实施例中,第一骨螺钉孔152集成到基座构件112中。在一些实施例中,第二骨螺钉孔254集成到可调节构件114中。
根据图21-23所示的示例实施例,骨螺钉150包含线性外螺纹轴252、第一端处的头部154以及在与第一端相对的第二端处的尖端156。在一些实施例中,尖端156是尖的。在一些实施例中,骨螺钉416的直径从头部154到尖端156保持恒定。头部154进一步包含被配置成接收安装工具的插口158。虽然此示例实施例具有六角头起子插口158,但应理解,插口158可被设计成接收多种不同类型的手动工具,包含一字螺丝刀、十字头螺丝刀、艾伦扳手螺丝刀、六角起子、梅花起子、罗伯逊起子、三翼螺丝刀、艾伦带孔起子、梅花带孔起子、百事易十字槽螺丝刀、离合器起子、扳手、Schrader起子、螺母起子、六角扳手、节点带孔起子、所列起子接口的任何组合以及任何其它类型的起子接口。
一旦将骨螺钉150插入骨中,就可以使用保持螺钉160来防止骨螺钉150后退。在示例实施例中,例如图24所示的实施例,保持螺钉160可包含头部282、工具端口284和螺纹轴。螺纹轴可拧入基座构件112中的第一螺纹孔260或可调节构件114中的第二螺纹孔261中,如图21-24所示。在一些实施例中,第一螺纹孔260集成到基座构件112中。在一些实施例中,第二螺纹孔261集成到可调节构件114中。
头部282进一步包含平坦部286和圆形肩部288。在一些实施例中,当平坦部286靠近骨螺钉的头部154时,保持螺钉160不与骨螺钉150接触,如图24所示。然而,保持螺钉160可以拧紧到第一螺纹孔260或第二螺纹孔261中,使得圆形肩部228靠近骨螺钉150。在一些实施例中,当将保持螺钉160拧紧到第一螺纹孔260或第二螺纹孔261中时,圆形肩部228的下侧与骨螺钉150的头部154接触。这样做时,可以使用保持螺钉160来防止骨螺钉150后退。
在图21-24所示的示例实施例中,保持螺钉160包含被配置成接收六角头起子的工具端口284。应理解,工具端口284可被设计成接收多种不同类型的手动工具,包含一字螺丝刀、十字头螺丝刀、艾伦扳手螺丝刀、六角起子、梅花起子、罗伯逊起子、三翼螺丝刀、艾伦带孔起子、梅花带孔起子、百事易十字槽螺丝刀、离合器起子、扳手、Schrader起子、螺母起子、六角扳手、节点带孔起子、所列起子接口的任何组合以及任何其它类型的起子接口。
现在总体上参考附图,本文公开的各种实施例提供了可扩张植入物,所述可扩张植入物包含基座构件、可调节地耦合到所述基座构件并且可在第一折叠位置与第二扩张位置之间移动的可调节构件,以及由基座构件可旋转地接收的控制轴,其中所述控制轴的旋转引起可调节构件相对于基座构件的相对运动。至少一个控制构件被接收在控制轴上并且由控制通道接收,并且控制轴的旋转引起控制构件沿控制轴并且沿控制通道平移。
在一些实施例中,当植入物处于第一折叠位置时,上支撑件的顶表面和下支撑件的底表面平行(见例如图1)。然而,在其它实施例中,当植入物处于第一折叠位置时,上支撑件的顶表面和下支撑件的底表面可以形成角度。在此示例实施例中,植入物在植入物的一个横向侧上的高度(即,上支撑件的顶表面与下支撑件的底表面之间的距离)将大于植入物的另一横向侧上的高度。在此实施例中,植入物可以线性地扩张(即,随着植入物扩张,角度保持恒定),或者植入物可以成角度地扩张(即,随着植入物扩张,角度增加)。
在一些实施例中,可调节构件相对于基座构件以线性方式移动。在其它实施例中,可调节构件相对于基座构件以非线性方式移动。在进一步的实施例中,可调节构件相对于基座构件绕枢转轴线枢转。枢转轴线可以由延伸穿过可调节构件和基座构件中的一个或两个的枢转销提供。
在一些实施例中,使用单个控制构件和控制通道。在其它实施例中,使用多个(例如,2个)控制构件和控制通道。在一些实施例中,多个控制通道是平行且笔直的。在其它实施例中,控制通道是非平行且笔直的(例如,彼此成角度)。在进一步的实施例中,控制通道是非平行和非笔直的,使得可调节构件相对于基座构件以非线性方式移动。
在一些实施例中,控制轴包含对应于每个控制构件的控制螺纹。因此,虽然在一些实施例中控制轴包含单个控制螺纹,但在其它实施例中,控制轴包含多个(例如,第一和第二)控制螺纹。在一些实施例中,控制螺纹是类似的螺纹。在其它实施例中,控制螺纹具有不同的螺纹。例如,在一些实施例中,第一控制螺纹与第二控制螺纹具有相反旋转方向。在进一步的实施例中,第一控制螺纹与第二控制螺纹具有不同的节距。在又一些实施例中,第一控制螺纹与第二控制螺纹具有不同旋转方向,并且具有不同的节距。
在一些实施例中,可调节构件和基座构件中的一个或两个包含突起/凹槽,以提供旨在促进抓握骨的相邻部分的抓握表面。在进一步的实施例中,可调节构件和基座构件中的一个或两个包含一个或多个孔和/或腔,所述孔和/或腔被配置成促进可调节构件和基座构件内和周围的骨生长。在一些实施例中,孔从可调节构件和基座构件的顶表面、底表面和/或侧表面延伸到植入物的中心腔。
根据本文公开的任何实施例,可以包含一个或多个骨螺钉,并将其定位成延伸穿过可调节构件和基座构件中的一个或两个并进入骨的相邻部分。在一些实施例中,使用多个骨螺钉。第一骨螺钉可延伸穿过可调节构件并进入骨的第一部分,并且第二骨螺钉可延伸穿过基座构件并进入骨的第二部分。在进一步的实施例中,多个骨螺钉可通过由可调节构件和基座构件中的一个或两个限定的植入物的前面接近和操纵。控制轴的头部和工具端口也可以通过植入物的前面接近。
在各种实施例中,可以利用控制轴/控制构件/控制通道的任何适当配置。在一些实施例中,至少部分球形控制构件螺纹接合螺纹控制轴,并沿控制轴且在控制通道内平移。在其它实施例中,控制构件是非球形的,并且至少部分地接收在由可调节构件提供的控制轨或控制通道上或之中,使得控制构件沿着控制轴和控制通道或控制轨两者平移。
重要的是应注意,在示范性实施例中示出的各种植入物和植入物部件的元件的构造和布置仅仅是说明性的。虽然在本公开中详细描述了几个实施例,但是审阅本公开的本领域技术人员将容易理解,在实质上不脱离各种实施例中所叙述的主题的新颖教导和优点的情况下,许多修改是可能的(例如,各种元件的大小、尺寸、结构、形状和比例、参数值、安装布置、材料的使用、颜色、定向等的变化)。因此,所有此类修改旨在被包含在如所附权利要求书定义的本公开的范围内。任何过程或方法步骤的次序或顺序可根据替代实施例变化或再定序。可在不脱离本公开的范围的情况下对示范性实施例的设计、操作条件和布置作出其它替代、修改、改变和/或省略。
如本文中所使用,术语“大致”、“约”、“基本上”和类似术语旨在具有与由本公开的主题所属的领域的普通技术人员常用和公认的用法相一致的广泛含义。对本公开进行审查的本领域技术人员应理解,这些术语旨在允许对所描述和所要求的某些特征进行描述,而不将这些特征的范围限于所提供的精确数值范围。因此,这些术语应解释为指示对所描述和所要求的主题的非实质性的或无关紧要的修改或改变被视为处于所附权利要求书中所述的本申请的范围内。
应注意,如本文中用来描述各种实施例的术语“示范性”旨在指示此类实施例是可能的示例、表示和/或可能实施例的说明(且此类术语并不旨在暗示此类实施例必须是特别的或最佳的示例)。
如本文中所使用,术语“耦合”、“连接”等意指两个构件直接或间接地彼此接合。此接合可以是静止的(例如,永久的)或可移动的(例如,可移除的或可释放的)。此接合可以通过两个构件或彼此一体地形成为单个整体的两个构件和任何额外中间构件来实现,或者通过两个构件或附接到彼此的两个构件和任何额外中间构件来实现。
本文中对元件的位置(例如,“顶”、“底”、“上”、“下”等)的引用仅用于描述附图中各个元件的定向。应注意,根据其它示范性实施例,各种元件的定向可以不同,且此类变化旨在被本公开所涵盖。
尽管图式和描述可说明方法步骤的特定次序,但除非上文以不同方式指定,否则此类步骤的次序可不同于所描绘和描述的次序。此外,除非上文以不同方式指定,否则可同时或部分同时地执行两个或更多个步骤。此变化可取决于例如所选择的硬件系统并取决于设计者选择。所有此类变化在本公开的范围内。
重要的是应注意,各种示范性实施例的构造和布置仅是说明性的。虽然在本公开中仅详细描述了几个实施例,但是审阅本公开的本领域技术人员将容易理解,在实质上不脱离本文描述的主题的新颖教导和优点的情况下,许多修改是可能的(例如,各种元件的大小、尺寸、结构、形状和比例、参数值、安装布置、材料的使用、颜色、定向等的变化)。例如,示出为整体形成的元件可以由多个部分或元件构成,元件的位置可以颠倒或以其它方式变化,并且离散元件的性质或数量或位置可以改变或变化。任何过程或方法步骤的次序或顺序可根据替代实施例变化或再定序。还可以在各种示范性实施例的设计、操作条件和布置中进行其它替换、修改、改变和省略,而不脱离本申请的范围。
应理解,本发明植入物和安装仪器的部件、结构和/或特征的尺寸可以在本公开的范围内根据需要改变。
Claims (20)
1.一种可扩张植入物,其包括:
基座构件,所述基座构件具有顶表面和与所述顶表面相对的底表面;
可调节构件,所述可调节构件可调节地耦合到所述基座构件,并且能在第一折叠位置与第二扩张位置之间移动,其中所述可调节构件具有顶表面和与所述顶表面相对的底表面;
第一横向侧,所述第一横向侧沿所述植入物的长度延伸;
第二横向侧,所述第二横向侧与所述第一横向侧相对且沿所述植入物的所述长度延伸;
其中所述可调节构件的所述顶表面和所述基座构件的所述底表面限定高度;
其中当所述植入物从第一位置移动到第二位置时,所述第一横向侧处的高度变化不同于所述第二横向侧处的高度变化。
2.根据权利要求1所述的可扩张植入物,其中当所述植入物处于所述第一折叠位置时,所述第一横向侧处的植入物高度基本上等于所述第二横向侧处的植入物高度。
3.根据权利要求1所述的可扩张植入物,其进一步包括控制组件,所述控制组件包含控制轴,其中所述控制轴的旋转引起所述可调节构件相对于所述基座构件的相对运动。
4.根据权利要求3所述的可扩张植入物,其中所述控制组件包含第一控制构件,所述第一控制构件接收在所述控制轴上,并且被配置成接收在所述可调节构件的第一控制通道内。
5.根据权利要求4所述的可扩张植入物,其中所述控制组件包含第二控制构件,所述第二控制构件接收在所述控制轴上,并且被配置成接收在所述可调节构件的第二控制通道内。
6.根据权利要求5所述的可扩张植入物,其中响应于所述控制轴在第一方向上转动,所述第一控制构件沿所述控制轴朝向所述第二控制构件移动;并且
其中响应于所述控制轴在第二方向上转动,所述第一控制构件沿所述控制轴远离所述第二控制构件移动。
7.根据权利要求3所述的可扩张植入物,其中所述控制轴使用凸轮螺钉固定;其中所述凸轮螺钉具有凸轮部,所述凸轮部被配置成接合所述控制轴。
8.一种可扩张植入物,其包括:
基座构件,所述基座构件包括导槽;
可调节构件,所述可调节构件可调节地耦合到所述基座构件,并且能在第一折叠位置与第二扩张位置之间移动,所述可调节构件包括导轨,所述导轨由所述导槽可滑动地接收,使得当所述可调节构件从所述第一折叠位置移动到所述第二扩张位置时,所述导轨在所述导槽内移动;
其中所述可调节构件相对于所述基座构件以非线性方式从所述第一折叠位置移动到所述第二扩张位置。
9.根据权利要求8所述的可扩张植入物,其中所述基座构件包括顶表面和与所述顶表面相对的底表面;
其中所述可调节构件具有顶表面和与所述顶表面相对的底表面;
其中所述基座构件的所述底表面在所述第一折叠位置基本上平行于所述可调节构件的所述顶表面。
10.根据权利要求9所述的可扩张植入物,其中在所述第二扩张位置,所述基座构件的所述底表面与所述可调节构件的所述顶表面形成第一角度,其中所述第一角度大于0度。
11.根据权利要求8所述的可扩张植入物,其进一步包括控制组件,所述控制组件包含控制轴,其中所述控制轴的旋转引起所述可调节构件相对于所述基座构件的相对运动。
12.根据权利要求11所述的可扩张植入物,其中所述控制组件包含第一控制构件,所述第一控制构件接收在所述控制轴上,并且被配置成接收在所述可调节构件的第一控制通道内。
13.根据权利要求12所述的可扩张植入物,其中所述控制组件包含第二控制构件,所述第二控制构件接收在所述控制轴上,并且被配置成接收在所述可调节构件的第二控制通道内。
14.根据权利要求13所述的可扩张植入物,其中响应于所述控制轴在第一方向上转动,所述第一控制构件沿所述控制轴朝向所述第二控制构件移动;并且
其中响应于所述控制轴在第二方向上转动,所述第一控制构件沿所述控制轴远离所述第二控制构件移动。
15.一种可扩张植入物,其包括:
基座构件,所述基座构件包括第一主体部分和被配置成接收锚固构件的第一横向板部分;
可调节构件,所述可调节构件包括第二主体部分和被配置成接收锚固构件的第二横向板部分,其中所述可调节构件可调节地耦合到所述基座构件,并且相对于所述基座构件在第一折叠位置与第二扩张位置之间非线性地移动;以及
控制组件,所述控制组件包括控制轴,其中所述控制轴的旋转引起所述可调节构件相对于所述基座构件的相对运动。
16.根据权利要求15所述的可扩张植入物,其进一步包括:
第一横向侧,所述第一横向侧沿所述植入物的长度延伸;
第二横向侧,所述第二横向侧与所述第一横向侧相对且沿所述植入物的所述长度延伸;
其中所述可调节构件具有顶表面,并且所述基座构件具有底表面;
其中所述可调节构件的所述顶表面和所述基座构件的所述底表面限定植入物高度;
其中当所述植入物处于所述第二扩张位置时,所述第一横向侧处的所述植入物高度大于所述第二横向侧处的所述植入物高度。
17.根据权利要求16所述的可扩张植入物,其中所述可调节构件的所述顶表面和所述基座构件的所述底表面在所述第一折叠位置基本上平行。
18.根据权利要求15所述的可扩张植入物,其中所述控制组件包含第一控制构件,所述第一控制构件接收在所述控制轴上,并且被配置成接收在所述可调节构件的第一控制通道内。
19.根据权利要求15所述的可扩张植入物,其进一步包括多个锚固构件,所述多个锚固构件包含所述锚固构件。
20.根据权利要求15所述的可扩张植入物,其进一步包括所述锚固构件,其中所述锚固构件使用保持螺钉固定,其中所述保持螺钉具有平坦部和圆形肩部。
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US20230181330A1 (en) | 2023-06-15 |
KR20230005835A (ko) | 2023-01-10 |
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