CN101146495A - 带有螺旋形翼部的棘突间植入物 - Google Patents
带有螺旋形翼部的棘突间植入物 Download PDFInfo
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- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
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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
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/17—Guides or aligning means for drills, mills, pins or wires
- A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
- A61B17/1757—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the spine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
- A61B17/7068—Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor
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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
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/441—Joints for the spine, e.g. vertebrae, spinal discs made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
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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
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/30289—Three-dimensional shapes helically-coiled
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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
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/30291—Three-dimensional shapes spirally-coiled, i.e. having a 2D spiral cross-section
Abstract
根据本发明的系统和方法包括植入物,该植入物包括间隔件(320)和骨架(302),该骨架具有中心体(304)和螺旋形翼部(360),该翼部从该中心体延伸。骨架可以定位在相邻棘突(2、4)附近,且可以被旋转和推进,使得相邻棘突经过翼部的凹槽(361)内,从而允许所述翼部布置在相邻棘突的相对侧。间隔件可以布置在骨架之上,使得间隔件接触和分离棘突,从而限制伸展过程中相邻棘突的相对运动。
Description
优先权声明
美国临时专利申请No.60/663,922,主题名称:INTERSPINOUSPROCESS IMPLANT HAVING A THREAD-SHAPED WING AND METHODOF IMPLANTATION,发明人:James F.Zucherman等,申请日:2005年3月21日(代理人案号:No.KLYC-01112US0);和
美国专利申请No.11/378,892,主题名称:INTERSPINOUS PROCESSIMPLANT HAVING A THREAD-SHAPED WING AND METHOD OFIMPLANTATION,发明人:James F.Zucherman等,申请日:2006年3月17日(代理人案号:No.KLYC-01112US1)。
技术领域
本发明涉及棘突间植入物
背景技术
脊柱是主要包括韧带、肌肉、椎骨和椎间盘的生物机械结构。脊柱的生物机械功能包括:(1)支撑身体,这涉及将体重以及头部、躯干和手臂的弯折运动传递到骨盆和腿部,(2)这些部分之间的复杂生理学运动,和(3)保护脊髓和神经根。
随着当前社会的老龄化,预见到不良脊柱状态将会增多,这种现象是老年人的特征。仅通过示例,随着老龄化的到来,脊柱狭窄(包括但不限于中央管和横向狭窄)和小平面关节病将会增多。脊柱狭窄导致椎孔面积(即,用于神经和血管通道的可用空间)减小,这将压迫脊椎神经根而导致神经根痛。Humpreys,S.C.et al.,Flexion and traction effect on C5-C6 foraminal space,Arch.Phys.Med.Rehabil.,vol.79 at 1105(Sept.1998).脊柱狭窄的另一种并发症是脊髓病,该病导致颈部疼痛和肌无力。同上。颈部的伸展和同侧转动进一步减小了椎孔面积和加剧疼痛、神经根压迫以及神经损伤。同上。Yoo,J.U.et al.,Effect of cervical spine motion on the neuroforaminal dimensions ofhuman cervical spine,Spine,vol.17 at 1131(Nov.10,1992).与此对照,颈部弯曲增加了椎孔面积。Humpreys,S.C.et al.,supra,at 1105。
与狭窄关联的疼痛可以用药物和/或手术缓解。希望消除对全部个人实施大手术的需要,特别是对老年人。
发明内容
因此,存在这样的需要,即研制脊柱植入物,该植入物可以缓解由脊柱狭窄导致的疼痛以及由脊柱损伤或者变性导致的其他这种情况。这种植入物将分离椎骨或者增加椎骨间空间,以增大椎孔面积并降低脊柱神经和血管上的压力。
存在这样的进一步需要,即研制用于脊柱植入物的最少侵入式手术植入方法,该方法能保护脊柱的生理学特征。
进而,存在这样的需要,即能适应脊柱不同解剖学结构的植入物,将对脊柱的进一步损伤降低到最小,并且不需要侵入式的外科植入方法。另外,存在这样的需要,即处理由脊柱伸展和/或弯曲所加剧的不良脊柱状况。
附图说明
图1A是植入物的透视图,该植入物包括泪滴形截面的间隔件、分离导向件、第一翼部、和可以连接到分离导向件的第二翼部;
图1B是植入物的透视图,该植入物包括椭圆形截面的旋转间隔件、分离导向件、第一翼部、和可以连接分离导向件的第二翼部;
图2A是根据本发明实施例的植入物骨架透视图;
图2B是用于图2A所示骨架的间隔件透视图;
图2C是支座在图2A所示骨架内的图2B所示间间隔件透视图;
图3A是图2A-2C所示的定位在相邻棘突之间椎间韧带附近的植入物骨架的后视局部截面图;
图3B是图2A-2C所示植入物骨架的后视局部截面图,该骨架旋转使得脊椎间韧带沿着植入物纵轴设置在部分螺旋形第二翼部和第一翼部之间;
图3C是图2A-2C所示植入物骨架的后视局部截面图,该骨架旋转使得脊椎间韧带沿着纵轴设置在全部螺旋形第二翼部和第一翼部之间;
图3D是图2A-2C所示植入物骨架的后视局部截面图,其中间隔件局部布置在骨架中心体之上,使得间隔件的一部分局部分离脊椎间韧带;
图3E是图2A-2C所示植入物骨架的后视局部截面图,其中间隔件支座在骨架中心体之上,使得间隔件一部分局部分离脊椎间韧带;
图4A是定位在相邻棘突间的图3E所示植入物的端视图;
图4B是定位在相邻棘突间的图3E所示植入物的前视图;
图5A是根据本发明的植入物替代实施例的骨架透视图;
图5B是用于图5A所示骨架的间隔件透视图;
图5C是支座在图5A骨架内的图5B所示间隔件的透视图;
图6是定位在相邻棘突间的图5A-5C所示植入物的侧视图;
图7A是根据本发明的植入物进一步实施例的骨架透视图;
图7B是定位在相邻棘突间的图7A所示骨架的侧视图;
图7C是定位在相邻棘突间且缩回以塌下第二翼部的图7A所示骨架的侧视图;
图8是根据本发明的植入物进一步实施例的骨架透视图;
图9图示了根据本发明用来将脊椎间植入物植入颈椎区域相邻棘突之间的方法实施例;
图10是根据本发明用来将脊椎间植入物植入腰椎区域相邻棘突间的方法流程图。
具体实施方式
脊椎间植入物
图1A是2004年5月20日提交的美国专利申请No.10/850,267所说明的植入物透视图,该申请文件通过引用包含在本文中。植入物100包括第一翼部130、间隔件120、和导入组织扩张器(这里也称为分离导向件)110。分离导向件110在该特别实施例中是楔形的,即植入物具有从植入物100近端部到导向件110结合间隔件120的区域150扩张的截面(对于图形的参照是基于棘突间植入物的插入点)。这样,当植入物100手术插入棘突之间时,分离导向件110用来初始分离软组织和棘突。应该理解,分离导向件110可以削尖或者类似加工,从而有利于植入物100插入到相邻颈椎的棘突之间。具有优势的是,插入技术尽可能少的影响骨头和周围组织或者韧带,从而减少对手术位置的创伤并促使早日愈合,而且防止正常解剖学特征失稳。对干如图1A和1B所示的实施例,不需要取下任何棘突骨头也不需要切断与棘突紧密关联的韧带和组织或者将之从身体中取出。例如,不需要切断下椎骨的棘上韧带或者局部垫着上颈椎骨棘突的项韧带(其相应于棘上韧带)。
可以看出,间隔件120垂直于植入物100纵轴125的截面可以是泪滴形的。以此方式,间隔件120的形状可以大致符合植入物100将要定位的相邻棘突间的楔形空间或者该空间的一部分。如图1A所示,间隔件120(和第一翼部108)造型成适应C6和C7椎骨棘突(和/或薄片)的解剖学形式或者轮廓,用来放置在这些棘突(即,C6-C7运动节段)之间。相同的形状或者该形状的变形可以用来适应其他运动节段,例如胸椎或者腰椎区域。在其他实施例中,间隔件120可以具有替代形状,诸如圆形、楔形、卵形、卵圆形、足球形、和带圆角的矩形以及其他形状。间隔件120的形状可以经过选择,用于特定的病人,使得医生可以将植入物100尽可能近地定位到棘突表面的前部。为间隔件120选择的形状可以影响植入物100和将要分离的棘突的接触表面区域。增大植入物100和棘突之间的接触表面区域可以在棘突骨架和植入物100之间分布载荷力。
第一翼部130在垂直于间隔件120和分离导向件110的纵轴125的截面上是类似的泪滴形。第一翼部130的尺度,特别是沿着脊柱轴线可以大于间隔件120,并且可以限制或者阻止植入物100沿着纵轴125在插入方向上的横向位移。与间隔件120一样,第一翼部130可以具有其他截面形状,诸如椭圆形、楔形、圆形、卵形、卵圆形、足球形、和带圆角的矩形以及其他形状。
图1A的植入物100进一步包括从分离导向件110分开的可调节翼部160(这里也称为第二翼部)、间隔件120和第一翼部130。植入物100定位在相邻棘突之间后,第二翼部160可以与分离导向件110(和/或间隔件120)连接。类似于第一翼部130,第二翼部160可以限制或者阻止植入物100的侧向位移,但是是限制或者阻止在相反于插入方向上的位移。当第一翼部130和第二翼部160连接到植入物100,且植入物100定位在相邻棘突之间时,棘突一部分可以夹在第一翼部130和第二翼部160之间,限制沿着纵轴125的位移。可以看出,第二翼部160可以有泪滴形截面。限定穿过第二翼部160的空间170的唇部180允许第二翼部160经过分离导向件110,从而碰到分离导向件110和/或间隔件120并与其连接。第二翼部160然后固定到分离导向件110和/或间隔件120。第二翼部160可以设计成干涉配合到间隔件120上或者配合到靠近间隔件120的分离导向件110一部分上。当第二翼部160干涉配合时,不存在额外的连接装置将第二翼部160相对于植入物100的剩余部分紧固。
可替代地,可以用各种紧固件来相对于植入物100的剩余部分固紧第二翼部160。例如,图1A图示了包括泪滴形第二翼部160的植入物100实施例,该第二翼部160具有舌部158,其位于第二翼部160的后端。孔155穿过舌部158设置,并且当通过手术将第二翼部160相对于植入物100的剩余部分插入就位时,该孔155与间隔件120上的相应孔156对齐。螺纹螺钉154可以沿前后方向插入穿过对齐的孔155、156,从而将第二翼部160固紧到间隔件120。从后向前的插入方向让螺钉154沿着通常垂直于纵轴125的方向啮合孔155、156以及植入物100的剩余部分。当要求医生用螺钉154将第二翼部160固紧到植入物100的剩余部分时,这种取向是最方便的。第二翼部160可以通过某些其他机构进一步固紧到间隔件120上,例如诸如带凸起的挠性铰链(未示出),该凸起啮合分离导向件110和间隔件120其中之一上的凹口。可替代地,第二翼部160可以通过某些其他机构固紧到分离导向件110和间隔件120其中之一上。
图1B是授予Zucherman等的美国专利No.6,695,842所述的植入物透视图,该专利文件通过引用包含在本申请中。植入物200具有主体,该主体包括间隔件220、第一翼部230、导入组织扩张器210(这里也称为分离导向件)和对齐导轨203。植入物200主体插入相邻棘突之间并且(根据需要)保留在位,而不连接到骨头或者韧带。
分离导向件210包括尖端,分离导向件210从该尖端扩展,该尖端直径足够小,使得该尖端能在脊椎间韧带上刺入开口和/或能插入到较小的初始扩张开口内。分离导向件210的直径和/或截面积逐渐增大,直到其基本上类似于间隔件220的直径。逐渐变细的前端使得医生容易将植入物200推进到相邻棘突之间。当把植入物200主体推进到相邻棘突之间时,分离导向件210前端分离相邻棘突并且扩张脊椎间韧带,使得相邻棘突之间的空间大约是间隔件220的直径。
如图1B所示,间隔件220有椭圆形截面,并且能转动,使得间隔件220能相对于棘突的非均匀表面自行对齐。自行对齐能保证压缩载荷分布在骨头表面上。如Zucherman’842所考虑的那样,间隔件220例如具有6毫米、8毫米、10毫米、12毫米和14毫米的直径。这些直径指间隔件220分离并保持棘突分开的高度。对于椭圆形间隔件220,所选择的高度(即,直径)是穿过椭圆的副尺度测量值。主尺度横穿棘突一上一下的对齐方向。
第一翼部230具有下部231和上部232。上部232造型成适应L4(用于L4-L5位置)或者L5(用于L5-S1位置)椎骨的棘突(和/或薄片)的解剖学形式或者轮廓。相同的形状或者该形状的变形可以用来适应其他运动节段,诸如颈椎和胸椎区域的运动节段。下部231也可以弄圆以适应棘突。当植入物200插入到相邻棘突之间时,第一翼部230的下部231和上部232用作停止机构。植入物200的插入不能超过第一翼部230的表面。另外,插入植入物200以后,第一翼部230可以防止植入物200的一些并排或者前后移动。
和图1A的植入物100一样,图1B的植入物200进一步包括第二翼部260。类似于第一翼部230,第二翼部260包括下部261和上部262,该上部262确定尺寸和/或造型成适应棘突和/或薄片的解剖学特征或者轮廓。第二翼部260可以用紧固件254固紧到植入物200的主体上。第二翼部260还具有对齐片268。当第二翼部260初始放置在植入物200的主体上的时候,对齐片268啮合对齐导轨203。对齐片268在对齐导轨203内滑动,并且帮助可调节的翼部260保持基本上与第一翼部230平行。当植入物200主体插入病人并且连接好第二翼部260的时候,沿着纵轴225在插入方向或者相反于插入方向的位移可以被限制或者阻止。而且,第二翼部260还防止一些并排或者前后移动。
对于图1A所示的植入物100和图1B所示的植入物200,在植入物100、200定位在棘突之间以后,第二翼部160、260与植入物100、200连接的情况下,用来定位这种植入物100、200并且随后将第二翼部160、260与植入物100、200连接的手术可能要求两侧切入,这时医生必须触及脊椎间韧带的两侧,触及第一侧以刺入和/或分离脊椎间韧带和定位植入物100、200,使得沿着插入方向的移动被第一翼部130、230令人满意地限制住,而触及第二侧以连接第二翼部160、260,使得沿着相反于插入方向的移动被第二翼部160、260令人满意地限制住。
带导入螺钉的植入物
参照图2A至3C,根据本发明的植入物300和用来定位这种植入物的方法,在一个实施例中可以包括具有中心体304的骨架302,该中心体304沿着植入物300纵轴325延伸。中心体304可以包括分离导向件306,其位于中心体304的近端。分离导向件306可以具有逐渐变细的形状,使得分离导向件306能刺入和/或分离与目标运动节段关联的脊椎间韧带。第一翼部330从中心体304远端延伸,并且用来限制或者阻止植入物300沿着纵轴325在插入方向上的移动。
基本上为螺纹形的导入螺钉(这里也称为第二翼部)360从中心体304的周边延伸,相对与分离导向件306定位较远。例如,第二翼部可以是螺旋形,其中螺旋形状通常是三维曲线,该曲线排列在圆柱或者圆锥上,使得其与垂直于轴线的平面所成的角度恒定。这里所述的螺旋形状不需要沿着恒定角度排列,而是可以沿着变化的角度排列。螺旋形状仅需要包括在重叠表面之间具有间隙361(这里也称为凹槽)的曲线,使得与相邻棘突有关的结构和棘突能经过凹槽361。应该理解,除螺旋形之外的导入螺钉形状也在本发明的精神和范围内。例如,可以使用带恒定直径螺纹的形状,或者带不同或者恒定螺距的形状。通常并且优选,第二翼部360具有这样的外径,该外径从中心体304近端附近朝向远处的第一翼部330稳步增大。第二翼部360终止,使得间隔件320(图2B)能布置在第二翼部360和第一翼部330之间。第二翼部360的螺旋形状有利于从形成在脊椎间韧带6一侧的一个或者多个切口植入到棘突2、4(如图3A-3E所示)之间,所述脊椎间韧带6在相邻棘突2、4之间延伸。
可以这样在上述的这个实施例中实现植入,即通过用分离导向件306初始刺入或者分离脊椎间韧带6,随后旋转中心体304。当中心体304旋转且中心体304沿着纵轴325在插入方向上推拉时,脊椎间韧带6和相邻棘突2、4其中之一或者两者在螺旋形第二翼部360的凹槽361内滑动。脊椎间韧带6和/或关联的棘突2、4沿着凹槽361行进并且因此沿着中心304行进,导致当植入物300支座好时,第二翼部360定位在相对于第一翼部330而言的脊椎间韧带6相对侧,使得脊椎间韧带6沿着纵轴325设置在第一翼部330和第二翼部360之间。将脊椎间韧带6、和/或关联的棘突2、4布置在第一翼部330和第二翼部360之间,限制或者阻止了沿着纵轴325的移动。
在某些实施例中,分离导向件306可以具有通常圆锥形,而不是如参照图1A和1B所述的楔形。在分离导向件306包括楔形的情况下,旋转中心体304可以导致分离导向件306以一定距离分离相邻棘突2、4和/或脊椎间韧带6,该距离相应于分离导向件306的主尺度。
参照图2A,和分离导向件306一样,第一翼部330具有圆形,具有基本上相同的主和副尺度。第一翼部330造型使得第一翼部330可以与中心主体304一起旋转,同时与周围结构的干涉最小。而且,第一翼部330的弄圆形状可以适应下面所述的槽,同时提供表面来在植入过程中接触相邻棘突2、4,从而限制沿着纵轴325在插入方向上的运动。但是,在其他实施例中,第一翼部330不需要弄圆的形状。
第一翼部330可以包括一个或者多个槽来接收间隔件320,使得间隔件320能布置在第二翼部360和第一翼部330之间的中心体304之上。如图所示,第一翼部330包括基本为弧形的两个槽332、334,并且布置成彼此相对。槽332、334周边之间的最大距离可以基本上限定间隔件320的副(或者可替代的主)尺度。槽332、334优选具有内表面,该内表面过渡到中心体304的外表面,使得当间隔件320被推进穿过槽332、334时,间隔件320靠接中心体304,从而允许一部分载荷传递到中心体304上。在其他实施例中,一个或者多个槽可以穿过第一翼部330设置,并且可以根据需要造型,使得一个或者多个槽具有相同或者不同几何形状。
图2B是间隔件320的透视图,该间隔件具有适配成接收在上述骨架302上的几何形状。间隔件320包括顶部322和底部324。(应该注意,植入物的某些部件这里称为“顶”和“底”部件,但是位置定语仅用来在类似部件之间进行区别,而不是限制本发明的用途)。顶部322和底部324具有支撑各相邻棘突2、4的外表面和靠接中心体304的内表面。如图所示,顶部322和底部324的一部分内表面开槽,从而大约符合中心体304的形状,从而将载荷传递到中心体304外表面。外表面是弧形的,且通常造型成类似于第一翼部330的槽332、334的外周边。在其他实施例中,例如在中心体是梯形或者其他形状时,顶部322、底部324以及相应的槽332、334可以类似地造型,以适应中心体304。可替代地,中心体304可以具有不规则或者非对称形状,以防止不正确地将间隔件320与骨架302配合。本领域技术人员应该理解该结构能造型的多种变形。
可以看出,顶部322和底部324包括各自导入组织扩张器321、323(这里也称为分离导向件)。用于顶部322和底部324的分离导向件321、323在间隔件320近端逐渐变细,从而允许分离导向件306分离相邻棘突2、4和/或脊椎间韧带6其中之一或者两者。
可以看出,顶部322和底部324,沿着垂直于纵轴325的截面一起剖开,可以具有劈开的泪滴形,类似于图1A中的间隔件120截面。以此方式,间隔件320的形状可以大致符合植入物300将要定位的相邻棘突之间的楔形空间或者该空间的一部分。相同的形状或者该形状的变形可以用来适应不同运动节段/或不同病人,如上所述。在其他实施例中,间隔件320可以具有替代形状,诸如圆形、椭圆形、楔形、卵形、卵圆形、足球形、和带圆角的矩形以及其他形状。间隔件320的形状可以为特定病人选择,让医生能将植入物300尽可能近地定位在棘突表面前部。为间隔件320选择的形状会影响植入物300和待接受分离的棘突的接触表面积。增大植入物300和棘突之间的接触表面积能将载荷力分布在脊柱骨架和植入物300之间。
顶部322和底部324从基部326延伸并且被基部326固定在相对位置上。可以看出,底部324比顶部322延伸地更远。如下面将要进一步详细讨论,顶部322沿着纵轴325相对于底部324长度被截短,以避免接触第二翼部360,该翼部在图2所示实施例中螺旋到中心体304上表面上的终止点。截短顶部322的额外优势在于,棘突更为舒缓地分离,随着间隔件320插入到骨架302中,首先分离底部324,然后分离顶部322。基部326沿着纵轴325可以根据需要具有一定长度,并且优选该长度足够将顶部322和底部324支撑在相对于彼此的至少半刚性位置。基部326可以包括腔329,用来接收插入工具和紧固件(未示出)其中之一或者两者。腔329可以相应于设置在中心体304内的螺纹腔309,当间隔件320支座好时,例如让骨架302和间隔件可以例如仅通过螺钉固定连接。
图2C是植入物300的透视图,其中间隔件320支座在骨架302内并且布置在中心体304之上。可以看出,间隔件320底部324比顶部322延伸地更远,并且不受第二翼部360阻碍,该第二翼部局部螺旋在底部324之上。第一翼部330和第二翼部360基本上沿着脊柱轴线具有主尺度,该尺度大于间隔件320的主尺度,从而阻止或者限制植入物300沿着纵轴325的运动。
图3A至3E是后视局部截面图,图示了定位在相邻棘突之间的植入物300。图3A图示了位于目标运动节段脊椎间韧带6附近的骨架302的分离导向件。骨架302可以被逆着脊椎间韧带6推进,以刺入和/或分离脊椎间韧带6。骨架302可以进一步被沿着纵轴325推进到脊椎间韧带6内,直到第二翼部360接触脊椎间韧带6。参照图3B,骨架302然后可以被旋转并且被朝向脊椎间韧带6推进,让第二翼部360经过脊椎间韧带6,从而该骨架被沿着纵轴325定位在第二翼部360的一部分和第一翼部330之间。脊椎间韧带6和相邻棘突2、4基本上设置在第二翼部360沿着纵轴325重叠的表面之间的槽361内。参照图3C,骨架302可以进一步被旋转并推进到脊柱间韧带6内,直到全部第二翼部360基本上布置成这样,即脊椎间韧带6设置在第一翼部330和第二翼部360之间。骨架302可以进一步被旋转,让槽332、334布置成接收间隔件320,这样施加到间隔件320上的载荷将充分分布在间隔件320的表面上(即,间隔件320大约符合目标运动节段的相邻棘突2、4接触表面之间的空间)。
参照图3D和3E,骨架302根据需要布置好以后,顶部322和底部324可以定位在相应槽332、334中,并且被推进到中心体304之上,使得顶部322和底部324进一步分离脊椎间韧带6和/或相邻棘突2、4。可以沿着插入方向推进间隔件320,直到基部326支靠着第一翼部330。在优选实施例中,顶部322和底部324可以布置成使得顶部322和底部324大约接触或者近似接触第二翼部360,使得间隔件320完全支撑相邻棘突2、4施加的载荷,而不会打滑。
图4A是定位在目标运动节段相邻棘突2、4之间的植入物300端视图。可以看出,基部326布置成相对于脊柱轴线略微成角度。可以看出,上棘突2包括略微朝下弯的下接触表面,且下棘突4包括也略微朝下弯的上接触表面。如图所示布置植入物300可以增加相邻棘突2、4和间隔件320在插入植入物300过程中的整体接触表面,使得基部326与脊柱轴线垂直对齐。增大整体接触表面可以减小从运动节段施加给间隔件320的应力,并且减小从间隔件施加给相邻棘突2、4的应力。
可以进一步看出,基部326可以包括腔329,在实施例中,该腔是直径大于第一翼部330上的相应腔309直径的孔。这种特征可以接收插入工具(未示出),用来协助植入,或者这种特征可以接收紧固件(未示出),诸如螺钉或者螺栓来将间隔件320固紧到骨架302上。其直径大于骨架302上的腔309的孔329可以允许接收紧固件头部,使得该头部不会延伸超过基部326的远端面。在其他实施例中,基部326可以包括一个或者多个额外的腔,用来接收锁定销,或者插入工具(未示出)的其他特征件,例如2004年3月30日授予Zucherman等的主题为“Mating Insertion Instruments for Spinal Implantsand Methods of Use”的美国专利No.6,712,819所述。
图4B是定位在目标运动节段相邻棘突2、4之间的植入物300正视图。可以看出,第二翼部360是螺旋形的,并且通过接触上棘突2可以限制或者阻止在相反于插入方向上的运动。而且,第二翼部360的一部分可以接触下棘突4。尽管示出第二翼部360包括螺旋形状,有点类似于海螺壳,但是在其他实施例中,第二翼部360可以具有不同与所示形状的形状。例如,第二翼部360远端可以比图示的或多或少重叠第二翼部360近端。可替代地,第二翼部360可以形成两个或者多个断开的节段,而不是不断开的螺旋线。而且进一步,第二翼部360可以包括槽,用来接收间隔件320上下部322、324的近端部件。在理解了所示的结构后,图3A-4B所示的形状的许多不同变形对于本领域技术人员而言是明显的。根据本发明的植入物并非旨在限制到这里所示和所述的内容,而是适用于全部这种植入物,只要这种植入物使用翼部,且翼部主尺度大于棘突之间空间的主尺度即可,其中可以在沿着插入方向推进所述植入物的同时,通过旋转所述植入物来将所述翼部大约定位。
现在参照图5A至5C,示出了根据本发明实施例的植入物400的替代实施例。图5A是包括中心体404的骨架402的透视图,该中心体在近端具有分离导向件406,在远端具有对齐凸起408。可以看出,第二翼部460类似于上述的第二翼部460。对齐凸起408从中心体404延伸,当间隔件420布置在中心体404之上时,用来对齐间隔件420,并且用来防止间隔件420在植入后相对于骨架402接着旋转。因此,对齐凸起408相应于间隔件420内的凹口427,中心体404局部设置在该凹口内。
图5B是间隔件420的透视图。间隔件420包括孔428,该孔至少局部穿过间隔件420设置,并且包括沿着孔428长度的凹口427,该凹口用来接收骨架402的对齐凸起408。间隔件420近端可以逐渐变细,以形成分离导向件426,用来分离脊椎间韧带6和/或运动节段的相邻棘突2、4。类似于图1B所示的旋转间隔件220,以及图2A-2C所示的植入物300,当间隔件420定位在骨架402之上并且位于棘突2、4之间以后,可以进一步旋转植入物400或者调整之,用来分布载荷。
如上所述,间隔件420可以具有垂直于纵轴425的截面,该截面是泪滴形的,类似于图1A和2A所示的间隔件120、320的截面。以此方式,间隔件420的形状大致符合植入物400将要定位于其中的、相邻棘突2、4之间的楔形空间或者该空间的一部分。相同形状或者该形状的变形可以用来适应不同运动节段和/或不同病人,如上所述。在其他实施例中,间隔件420可以具有替代形状,诸如圆形、椭圆形、楔形、卵形、卵圆形、足球形、和带圆角的矩形以及其他形状。间隔件420的形状经过选择,用于特定病人,使得医生能尽可能近地将植入物400定位到棘突2、4表面前部。为间隔件420选择的形状会影响植入物400和将要接受分离的棘突2、4之间的接触表面积。增大植入物400和棘突2、4之间的接触表面积可以在脊椎骨架和植入物400之间分布载荷力。
图5B的间隔件420从第一翼部430延伸,该翼部与间隔件420整体形成或者连接到该间隔件。可以看出,间隔件420近端长度变化,更远地延伸到间隔件420底部节段附近,以大致相应于第二翼部460的螺旋形状,从而避免接触第二翼部460,该第二翼部在图5A所示的实施例中螺旋到中心体404上表面上的终止点。如上所述,一旦骨架404根据需要布置好以后,间隔件420可以定位在中心体404之上,并且被推进经过中心体404,使得间隔件420进一步分离脊椎间韧带和/或相邻棘突。可以进一步沿着插入方向推进间隔件420,直到中心体404支座在孔428内。在优选实施例中,间隔件420近端的形状造型成这样,即支座时,近端大约接触或者近似接触第二翼部460,使得间隔件420完全支撑相邻棘突施加的载荷,而不会打滑。
第一翼部430可以根据需要具有沿着纵轴425的深度和宽度,使得第一翼部430可以接触相邻棘突2、4其中之一或者两者,从而限制或者阻止植入物400沿着纵轴425在插入方向上的运动。如图所示,第一翼部430具有弄圆的形状,该形状具有基本上相同的副和主尺度。不像图2A-2C所示的植入物300实施例那样,第一翼部430不需要旋转来恰当地布置第二翼部460,因此第一翼部430不必具有弄圆的形状,根据需要,第二翼部420具有某些其他形状。例如,第一翼部430包括类似于图1B所示的形状。第一翼部430可以包括腔429,用来接收插入工具(未示出)其中之一或者两者。而且,中心体404可以任选地包括腔409,使得例如间隔件420支座好的时候,骨架402、间隔件420以及第一翼部430可以固定连接。
图5C是植入物400的透视图,其中间隔件420定位成支座在骨架402上,并且布置在中心体404之上。第一翼部430和第二翼部460具有大约沿着脊柱轴线的主尺度,该尺度大于间隔件420的主尺度,从而阻止或者限制植入物400沿着纵轴425的运动。图6如图5A-5C所述设置在相邻棘突之间的植入物400的后视图。
在某些包括类似于图2A-5C所示的植入物300、400的系统的实施例中,多个不同间隔件320、420可以选择性地与单个骨架302、402关联,使得医生能选择恰当尺寸和形状的间隔件320、420以适应病人的解剖学特征。在包括从第一翼部330延伸的中心体304的实施例中,两个槽332、334的外周边之间的距离相应于最大间隔件尺寸(例如,14mm)。在包括具有对齐凸起408的中心体404的实施例中,一系列间隔件420可以具有变化的尺度和/或形状,并且可以具有类似尺寸的腔428来接收中心体404。从本说明中容易理解,根据本发明实施例的系统可以包括骨架302、402和多个具有不同尺寸和/或形状的间隔件320、420。
如上所述,根据本发明的植入物、系统以及用来将这种植入物定位在棘突之间的方法并不表示限制到上述的和这里的实施例,而是意在表示包括全部这种植入物,只要他们使用了翼部,且该翼部的主尺度大于棘突之间空间的主尺度即可,其中在将所述植入物沿着插入方向推进的同时,通过旋转所述植入物来将所述翼部恰当定位。对于本领域技术人员而言,许多不同变形是明显的。例如,如图7A至7C所示,在根据本发明的植入物500另一个实施例中,骨架502可以包括内中心体504,该中心体设置在外中心体505内,使得第二翼部560的近端部分与内中心体504连接,或者从内中心体504延伸,而且第二翼部560的远端部分与外中心体505连接,或者从外中心体505延伸。一旦骨架502根据需要布置,使得脊椎间韧带设置在第一翼部530和第二翼部560之间以后,内中心体504可以移动到一个位置,该位置更为完全地接收在外中心体505内,使得第二翼部560压扁,减小第二翼部560占用的空间。
在如图7A至7C所示的这种实施例中,第二翼部560可以用更为柔韧的材料制成,使得第二翼部560容易压扁。可替代地,第二翼部560可以用形状记忆材料制成,例如诸如镍钛金属,使得骨架定位后,第二翼部560被压扁,促使内中心体504在外中心体505内移动。另外,第二翼部560可以制成两个部件,一个部件紧固到内中心体504上,一个部件紧固到外中心体505上。当内中心体504更为完全地接收在外中心体505内时,固紧到内中心体504的第二翼部560的那部分嵌入到连接在外中心体505的第二翼部560的那部分内
如图8所示,在更进一步的实施例中,根据本发明的植入物600包括更为舒缓地逐渐变细的分离导向件606,使得相邻棘突和/或有关组织随着导入螺钉660的旋转以及朝向插入方向推进而分离,如上所述。
在更进一步的实施例中,间隔件不需要固定,而是可以旋转设置在中心体之上。例如,间隔件可以包括对齐缺口,如上参照图1B所述,使得当中心体旋转,从而在螺纹形翼部的凹槽内旋拧相邻棘突和有关组织并且将螺纹形翼部定位在相邻棘突的相对侧部时,间隔件可以保持在固定位置。通过将间隔件固定就位,间隔件可以根据需要布置在相邻棘突之间。一旦植入物定位在相邻棘突之间后,可以释放旋转间隔件,以符合棘突之间的空间。这些结构以及其他变形都在本发明考虑范围内。
用于本发明植入物的材料
在某些实施例中,植入物以及植入物的组件(即,间隔件、骨架等)可以用医用级金属诸如钛、不锈钢、钴铬、他们的合金或者其他具有类似的高强度和生物相容特性的适当植入材料制成。另外,植入物可以至少局部由形状记忆金属制成,例如镍钛,该金属是钛和镍的结合物。这种材料是典型不透射线的,且在X射线造影和其他类型的造影过程中显现。根据本发明的植入物,和/或其部分还可以用某些挠性和/或可偏转材料制成。在这些实施例中,植入物和/或其部分可以全部或者局部用医用级生物相容聚合物、共聚物、混合物和聚合物复合物制成。共聚物是从多于一种单体派生出来的聚合物。聚合物复合物是两种或者多种材料的异质结合物,其中组分是不相混合的,因此展现处彼此之间的界面。聚合物混合物是两种或者多种不同种聚合物的宏观均匀混合物。许多聚合物、共聚物、混合物和聚合物复合物是射线透射的,且在X射线或者其他类型的造影中不显现。包括这种材料的植入物较之包括全部不透射线材料的植入物,在造影时可以为医生带来较少的脊柱成像阻碍。但是,植入物不必包括任何射线透射材料。
一族生物相容聚合物是聚芳醚酮族,该族包括几个成员,包括聚醚醚酮(PEEK)、和聚醚酮酮(PEKK)。PEEK被证明是用于植入物的结实材料,并且满足生物相容性标准。医用级PEEK可以从Victrex Corporation ofLancashire,Great Britain旗下的产品名为PEEK-OPTIMA的产品获得。医用级PEKK可以从Oxford Performance Materials旗下的名称为OXPEKK的产品获得,也可以从CoorsTek旗下的名为BioPEKK的产品获得。这些医用级材料还作为增强型聚合物树脂获得,这种增强型树脂显示出更大的材料强度。在实施例中,植入物可以用PEEK 450G制成,该材料是未填充的PEEK,经批准用于医疗植入物,可以从Victrex获得。这种材料的其他来源包括位于印度Panoli的Gharda。PEEK 450G具有以下近似特性:
特性 值
密度 1.3g/cc
RockwellM 99
RockwellR 126
拉伸强度 97MPa
弹性模量 3.5GPa
挠曲模量 4.1Gpa
PEEK 450G具有适当的物理机械特性,且适合在相邻棘突之间承受和传播物理载荷。植入物和/或其部分可以通过挤出、注射、压力模塑和/或机加工技术形成。
应当注意,所选的材料也可以是填充的。填料可以添加到聚合物、共聚物、聚合物混合物、或者聚合物复合物,以增强聚合物材料。添加填料来改变特性,诸如机械、光学和热特性。例如,可以添加碳纤维来机械地增强该聚合物,为特定用途提高强度,诸如为载荷承载装置。在某些实施例中,其他级别的PEEK也是可用的,且被考虑用作根据本发明的植入物,诸如30%玻璃填充或者30%碳填充级别的PEEK,只要这种材料被FDA或者其他管理机构明确为可以用于可植入装置。相对于未填充的PEEK,玻璃填充的PEEK降低了延展率,但是增加了PEEK的挠曲模量。制成的产品已知对于改善强度、刚性或者稳定性是理想的。相对于未填充的PEEK,碳填充的PEEK已知具有提升的压缩强度和刚性,但是降低了延展率。碳填充的PEEK还提供耐磨性以及承载能力。
应该理解,其他适当的类似生物相容热塑性或者热塑性缩聚物材料也可以使用,且不脱离本发明的范围,其中所述的材料要耐疲劳,具有良好的记忆,且是挠性的和/或可偏折的,具有非常低的吸水性,和良好的耐磨和/或抗磨性。正如所提及的,植入物可以包括聚醚酮酮(PEKK)。其他可用的材料包括聚醚酮(PEK),聚醚酮醚酮酮(PEKEKK),聚醚醚酮酮(PEEKK),且通常包括聚芳基醚酮。而且,也可以用其他聚醚酮和其他热塑性材料。用于植入物的适当聚合物的参考文献可以参照以下文件,他们全部作为参考文献包括在此。这些文件包括:PCT公开WO02/02158A1,公开日2002年1月10日,主题名称“Bio-Compatible Polymeric Materials”,PCT公开WO02/00275A1,公开日2002年1月3日,主题名称“Bio-Compatible PolymericMaterials”,和PCT公开WO02/00270A1,公开日2002年1月3日,主题名称“Bio-Compatible Polymeric Materials”。其他材料诸如Bionate,聚碳酸酯聚氨酯,从Polymer Technology Group,Berkeley,California可以获得,也是适当的,因为其具有良好的氧化稳定性、生物相容性、机械强度和耐磨性。也可以用其他热塑性材料和其他高分子量聚合物。
用于植入脊椎间植入物的方法
这里公开了教导了用于将植入物300植入颈椎的最少侵入式手术方法。在该方法中,如图9所示,优选导向线缆680经过放置网络690插入到植入物受体颈部。导向线缆680用来确定植入物300相对于颈椎包括棘突而言放在哪里。一旦导向线缆680在成像技术协助下定位以后,在颈部一侧切口,使得根据本发明实施例的植入物300可以穿过该切口并且沿着大约垂直于导向线缆680的线路定位在颈部,并且在导向线缆680的端部被引导。植入物300的骨架302插入病人颈部。骨架302包括分离导向件306,该分离导向件从中心体304近端延伸;和第一翼部330,该第一翼部从中心体304远端延伸。骨架302进一步包括螺旋形第二翼部360,该第二翼部从分离导向件306向远处沿着中心体304延伸一定距离。优选在插入过程中,分离导向件306刺入或者分开组织,而不会切断组织。骨架302可以这样布置,使得从中心体304延伸的第二翼部360接触或者近似接触脊椎间韧带。然后沿着一定方向旋转骨架302,使得第二翼部360的螺旋延伸部“生长”,并且向前推进骨架302,使得相邻棘突配合在第二翼部360的螺旋表面之间的凹槽内。继续旋转骨架302,直到第二翼部360经过相邻棘突2、4。
进一步旋转骨架302,直到第一翼部330的槽332、334根据需要布置在目标运动节段相邻棘突2、4之间。一旦令人满意地定位骨架302以后,将间隔件320与骨架302匹配,使得间隔件320上部322和下部324通过第一翼部330的各自槽332、334被接收(或者简单地接收在中心体304之上,例如在第一翼部330从间隔件320延伸,而不是从中心体304延伸的情况下)。可以将间隔件320沿着通常与骨架302的插入线路共线的线路插入。颈部的解剖学特征使得相对于骨架302和间隔件320而言,最方便和最少侵入式地从侧面进入颈部。
而且,这里公开和教导了用来将植入物300植入到腰椎的最少侵入式手术方法。在该方法中,如图10的流程图所示,优选通过前后方法制作单边切口。例如,该单边切口可以开在距离沿着棘突2、4轴线右边一定距离的位置(步骤102)。扩张该切口,将分离工具定位在该切口内,使得分离工具近端触及脊椎间韧带6的暴露侧。然后穿过脊椎间韧带6推进分离工具,并将之分离,从而分离脊椎间韧带6以接收植入物300(步骤104)。脊椎间韧带6充分分离后,分离工具可以解脱并从切口中取出。
分离工具从切口中取出后,可以将骨架302定位在扩张的开口处,且可以将骨架302的分离导向件306推进穿过该扩张的开口(步骤106)。如上所述,将骨架302这样布置,使得从中心体304延伸的第二翼部360与脊椎间韧带6近似接触。然后沿一定方向旋转骨架302使得第二翼部360的螺旋延伸部“生长”,且向前推进骨架302,使得相邻棘突2、4配合在第二翼部360的表面之间的凹槽内(步骤108)。然后继续旋转骨架302,直到第二翼部360经过相邻棘突2、4。
可以进一步旋转骨架300,直到槽332、334根据需要布置在目标运动节段相邻棘突之间。骨架302自由旋转,使得载荷可以更为均匀地分布在棘突表面上。一旦令人满意地定位骨架302以后,可以插入间隔件320,使得第一翼部320的槽322、324从中心体304远端延伸(或者简单地接收在中心主体之上,例如在第一翼部从间隔件延伸的情况下)。然后沿着通常与骨架302的插入线路共线的线路插入间隔件320(步骤110)。从切口中取出剩下的工具,然后闭合切口。优选在插入过程中,分离端刺入或者分开组织而不切断组织(步骤112)。
为图示和说明目的给出了本发明的前述说明。其并非旨在穷举或者将本发明限制到所述公开的精确形式。对于本领域技术人员而言,许多改动和变形是明显的。所选择和说明的实施例是为了最好地解释本发明的原理及其实际应用,从而让本领域的其他技术人员理解本发明的各种实施例,以及适合所考虑的特定用途时所具有的各种改动。这旨在表明本发明的范围由随后的权利要求及其等同物所限定。
Claims (20)
1.一种适配成插入到棘突之间的脊椎间植入物,该植入物包括:
间隔件,该间隔件适配成定位在棘突之间;
导入螺钉,该螺钉适配成在棘突之间引导植入物,使得该间隔件有选择地设置在棘突之间。
2.如权利要求1所述的植入物,进一步包括:
中心体,该中心体具有第一端和第二端;
翼部,该翼部从所述第二端延伸;以及
其中,
导入螺钉从所述第一端延伸;和
间隔件设置在中心体之上,位于导入螺钉和所述翼部之间。
3.一种适配成插入到棘突之间的脊椎间植入物,该植入物包括:
中心体;
翼部,该翼部从所述中心体延伸,该翼部大约是螺纹形;和
间隔件,该间隔件设置在中心体之上;
其中,通过旋转所述中心体和推进所述中心体使得相邻棘突在螺纹形翼部内移动,从而将所述中心体定位在相邻棘突之间。
4.如权利要求3所述的植入物,进一步包括从所述翼部延伸的分离导向件。
5.如权利要求3所述的植入物,其特征在于,所述间隔件可以相对于所述中心体旋转。
6.如权利要求3所述的植入物,其特征在于:
所述中心体包括第一端和第二端;
所述翼部从所述第一端延伸;和
进一步包括:
从所述第二端延伸的另一个翼部,所述另一个翼部包括槽;和
其中所述间隔件适配成通过所述槽接收在所述中心体之上。
7.如权利要求4所述的植入物,其特征在于:
对齐凸起从所述中心体的第二端延伸;和
间隔件包括腔,该腔接收所述中心体;和凹口,该凹口接收所述对齐凸起。
8.如权利要求6所述的植入物,其特征在于,所述间隔件包括用来接收所述中心体的腔。
9.一种适配成插入到棘突之间的脊椎间植入物,该植入物包括:
骨架,该骨架包括:
中心体,该中心体具有第一端和第二端;
第一翼部,该第一翼部从所述第二端延伸;和
第二翼部,该第二翼部从所述第一端延伸;
其中所述第二翼部大约是螺旋形的;和
其中通过旋转所述中心体并且推进所述中心体使得相邻棘突在所述第二翼部的螺纹形状内移动,从而将所述中心体定位在相邻棘突之间;以及
间隔件,适配成与所述骨架关联使得所述间隔件接收在所述中心体的至少一部分之上。
10.如权利要求9所述的植入物,其特征在于,所述间隔件包括分离导向件。
11.如权利要求9所述的植入物,其特征在于:
所述第一翼部包括槽;和
间隔件包括腔,使得所述间隔件能穿过所述槽接收在所述中心体之上。
12.如权利要求9所述的植入物,其特征在于:
所述第一翼部包括第一槽和第二槽;和
所述间隔件包括适配成通过所述第一槽接收在所述中心体之上的第一部分;和适配成通过所述第二槽接收在所述中心体之上的第二部分。
13.如权利要求9所述的植入物,其特征在于,所述螺纹形状是螺旋形的。
14.一种适配成插入到棘突之间的脊椎间植入物,该植入物包括:
外中心体;
内中心体,该内中心体至少局部可以从所述外中心体延伸;
翼部,该翼部至少从内中心体延伸,该翼部大致是螺纹形的;和
间隔件,该间隔件有选择地设置在所述外中心体之上;
其中所述内中心体可以接收在所述外中心体内,使得所述翼部可以被推进到压扁的构形。
15.如权利要求14所述的植入物,其特征在于,所述间隔件朝向所述导入螺钉后方定位。
16.如权利要求1所述的植入物,其特征在于,所述间隔件可以旋转。
17.如权利要求1所述的植入物,其特征在于,所述导入螺钉是螺旋形的。
18.如权利要求1所述的植入物,其特征在于,所述导入螺钉限定分离斜坡。
19.一种适配成插入到棘突之间的脊椎间植入物,该植入物包括:
中心体;
组织扩张器,该扩张器从所述中心体的第一端延伸;
翼部,该翼部定位在所述中心体的第二端附近;
间隔件,在所述中心体定位在棘突之间后,该间隔件适配成定位在棘突之间;和
所述间隔件包括腔,使得所述间隔件可以被推进经过所述翼部并且接收在所述中心体的至少一部分之上,且使得所述中心体接收在棘突之间。
20.如权利要求19所述的植入物,其特征在于:
所述翼部包括槽;和
所述间隔件可以被穿过所述翼部的所述槽接收,使得所述间隔件的所述腔接收在所述中心体的至少一部分之上。
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US11/378,892 | 2006-03-17 | ||
US11/378,892 US8147548B2 (en) | 2005-03-21 | 2006-03-17 | Interspinous process implant having a thread-shaped wing and method of implantation |
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CN101146495A true CN101146495A (zh) | 2008-03-19 |
CN101146495B CN101146495B (zh) | 2010-06-09 |
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CN2006800089080A Expired - Fee Related CN101146495B (zh) | 2005-03-21 | 2006-03-21 | 带有螺旋形翼部的棘突间植入物 |
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US (3) | US8147548B2 (zh) |
EP (1) | EP1868537B1 (zh) |
JP (1) | JP4861404B2 (zh) |
KR (1) | KR20080040619A (zh) |
CN (1) | CN101146495B (zh) |
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US20060265066A1 (en) | 2006-11-23 |
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EP1868537B1 (en) | 2012-05-16 |
AU2006227004A1 (en) | 2006-09-28 |
JP2008532731A (ja) | 2008-08-21 |
KR20080040619A (ko) | 2008-05-08 |
JP4861404B2 (ja) | 2012-01-25 |
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US20120083843A1 (en) | 2012-04-05 |
US8273107B2 (en) | 2012-09-25 |
EP1868537A4 (en) | 2009-11-04 |
US20080046086A1 (en) | 2008-02-21 |
WO2006102428A1 (en) | 2006-09-28 |
AU2006227004A2 (en) | 2006-09-28 |
US8591546B2 (en) | 2013-11-26 |
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