CN101031259A - 用于骨头复原的方法和装置 - Google Patents
用于骨头复原的方法和装置 Download PDFInfo
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- CN101031259A CN101031259A CNA2005800190749A CN200580019074A CN101031259A CN 101031259 A CN101031259 A CN 101031259A CN A2005800190749 A CNA2005800190749 A CN A2005800190749A CN 200580019074 A CN200580019074 A CN 200580019074A CN 101031259 A CN101031259 A CN 101031259A
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- implant
- bone
- pipe
- support
- plate
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- A61F2220/0091—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0069—Three-dimensional shapes cylindrical
-
- 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
- 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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- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
Abstract
用于复原人体或动物骨头解剖结构的方法和装置,可包括将能够在单个确定面中展开的可展开植入物插入骨头,将可展开植入物定位在骨头中,以使单个确定面与骨头复原面一致,并使可展开植入物在骨头复原面中张开。第一支撑面和第二支撑面展开在骨头内的组织。本发明的实施例还可包括将填充材料注射到植入物的周围。
Description
本申请要求在2004年9月29日提交的美国专利申请No.10/951776和在2004年6月9日提交的法国专利申请No.0406211的优先权,通过参考将这两篇申请的全部内容并入此文。
技术领域
本发明涉及外科和医用植入物的领域,更具体地涉及使用医用骨头植入物复原人体或动物骨头组织的装置和方法。
背景技术
骨头压缩,尤其是骨质疏松症以及外伤的根原可为各种原因,而有时联合了两个原因,其中骨质疏松症在个体的重量下引起(例如)椎骨压缩。这种骨头压缩可影响到椎骨,并且影响到其它骨头,例如,桡骨和股骨。
已知几种实施椎骨校正,将椎骨复原为其原始形状或类似于原始形状的椎骨成形技术。例如,一种技术包括:将可膨胀橡皮球植入椎骨,然后将压力液体引入橡皮球以推动椎骨的表壳,尤其是上下椎骨平台,以在压力的效果下校正椎骨的形状。该技术称为椎体后凸成形术(kyphoplasty)。一旦校正了骨质表壳,橡皮球就缩小,并从椎骨取出,以能够及时将粘固粉(cement)注射到需要给予足够的机械阻力的表壳中以使校正达很长持续时间。
椎体后凸成形术的值得注意的缺点在于其大量的操作,尤其是膨胀操作及必须将橡皮球从患者体内取出。另外,由于橡皮球的体积为多方向的,所以难以控制橡皮球的膨胀,这常常在表壳上沿不适当的方向引起大的压力。这种大的压力具有使表壳破裂的危险,尤其是,表壳与椎骨的下平台和上平台相连的侧面部分。
还具有其它用于填充椎骨中的空腔的椎骨植入物。但是,这种植入物通常采用通过形成多个点得到的径向膨胀规律,其中的多个点在植入物收缩效果下通常位于植入物纵轴上。这种植入物在单个点上施加了过高的压力,可能将该点支撑的材料刺破。另外,类似于椎体后凸成形术,太高的压力可引起组织或器官壁的破裂,例如表壳。另外,一些植入物的径向膨胀不允许期望的特定膨胀方向。
发明内容
本发明的实施例减少了上述缺陷,并提供超越现有骨头复原装置的额外的优点。更具体地,本发明的一些实施例包括复原人体或动物骨头解剖结构的方法,包括下列一个或多个步骤:
-根据单个确定的展开面,优选地为植入物的固有面,将可展开植入物植入骨头以复原;
-在骨头中定位可展开植入物,以使展开面与骨头复原面一致;
-使可展开植入物在骨头复原面中展开;以及
-在植入物中和/或植入物周围注射填充材料。
根据本发明一些实施例的方法,允许设置加强结构,产生坚固的结构(即,借助于植入物的展开,植入物与硬化的填充材料结合在一起)。另外,由于植入物保持到位,这使通过植入物展开校正的骨头结构的尺寸得以保持,所以可以在比较低的压力下注射填充材料。
本发明实施例的另一个特征是,可展开植入物可在骨头复原面内展开到确定的值:在最小厚度(例如,任何展开之前的植入物厚度)与最大厚度(例如,最大展开之后的植入物厚度)之间。该特征允许,例如,对于给定的椎骨校正控制植入物的展开值。
本发明实施例的另一个有利的特征包括通过展开第一和/或第二相对的板使可展开植入物展开,(分别)形成第一和第二骨头支撑面。该特征允许通过增加组织上的接触表面或支撑表面,减小植入物施加在与植入物接触的组织上的压力。
植入物的长度还可设定为基本上等于骨头中第一和第二支撑表面的至少一个。该特征允许使(在组织上的)支撑长度与植入物长度的比值达到最优。该比值越接近于一,植入物在需要小长度的位置中就越能维持下去。另外,该特征还允许在低注射压力注射填充材料。为避免将填充材料注进不适当的组织(例如,血管壁),低注射压力是更有利的。
在本发明的另一个实施例中,各第一板和第二板可部分地形成圆柱形支撑表面,该圆柱形支撑表面的一部分(或更多部分)可平行于可展开植入物的纵轴。圆柱形(弯曲)支撑表面可将植入物施加在组织上的力分散开。
在本发明的另一个实施例中,植入物的所述第一板和第二板的张开利用在板下方的一个或多个支撑。该特征允许将支撑表面长度与植入物长度的比值尽提高到可能地接近于一(1)(参见上面)。另外,该特征允许在板下方更均匀地分配推力,以减少悬臂(cantilever)。
为对在骨头复原中使用植入物产生的压缩载荷有帮助,可在植入物中和/或植入物周围注射填充粘固粉,包括离子粘固粉,尤其是磷酸钙粘固粉、炳烯酸类粘固粉或后者的混合物。从而,植入物与粘固粉的结合与建筑物构造中的钢筋混凝土结构没有区别。
在本发明的另一个实施例中,用于骨头复原的可展开植入物包括植入物固有的单个展开面。该单个展开面对应于骨头复原面。植入物还可包括第一和第二相对的板,其分别形成第一和第二骨头支撑面。沿单个展开面,将第一和第二板设置为从彼此移动离开(例如,在植入物展开时)。植入物还可包括用于一个或多个第一和第二支持支撑面的第一和第二支撑,并且所述支撑优选地位于一个板的下方或(分别)位于两个板的下方。植入物还可包括用于控制植入物展开的装置。该装置可包括设置在各支撑与对应的板之间的材料腹板,具有确定的厚度。
在本发明的另一个实施例中,用于控制展开的装置控制植入物展开之前的最小厚度与植入物最大展开之后的最大厚度之间的展开值。
植入物还可包括(优选地)用于在骨头中定位可展开植入物的装置,以使植入物的展开面与骨头复原面基本上一致。该装置可包括允许植入物绕着纵轴角度定向的接合装置(例如,螺纹接合),并且可在植入物的一端包括一个或多个平坦表面,用以(例如)与植入物支架接合。
本发明的另一个实施例把注意力贯注于骨头复原系统,可包括至少一个可展开植入物,其具有对应于骨头复原面的单个展开面(在单个骨头中可使用一个或多个植入物,以产生更加均匀的骨头复原;参见图37)。该系统还可包括第一管和第一杆,其中第一管用于与要复原的骨头的外表面相邻地定位,第一杆具有用于固定进骨头内部远端的螺纹端(第一杆可容纳在第一管内)。该系统还可包括用于在其中容纳第一管的第二管和用于接受第二管的第三管。第三管可包括一个或多个接合元件,用来将第三管固定在骨头的外表面上。该系统还可包括由第一杆导向的钻头,用来在骨头的一侧开设扩大的孔。此外,该系统还可包括机械插入装置,用来将可展开植入物插入患者体内。
在本发明的另一个实施例中,公开了一种用于将可展开植入物插入患者体内的机械插入装置。该装置可包括夹紧部分(该夹紧部分具有中心孔)、容纳在中心孔内的第一管和容纳在第一管内的螺纹杆,其中螺纹杆可包括用来接收插入患者体内的植入物的远端。该装置还可包括连接到夹紧部分和/或植入物支架的手柄以及用来确定植入物的展开量尺(gauge)。
参考附图、下面给出的简要说明以及随后的详细说明,会更加清楚地了解本发明的其它特征、优点、实施方式和目的。
附图说明
图1A示出了根据本发明实施方式的可展开植入物在静止位置的透视图;
图1B示出了图1A的实例在张开/展开位置的视图;
图2A示出了根据本发明另一个实施方式的可展开植入物的另一个实施例在静止位置的侧视图;
图2B示出了图2A的实例在张开/展开位置的视图;
图3示出了根据图1A的实例的侧视图;
图4示出了沿着图3的线I-I的剖视图;
图5示出了沿着图3的线II-II的剖视图;
图6示出了从图1A的实例的F方向观看的端部视图;
图7示出了从图1A的实例的上方观看的视图;
图8示出了根据本发明另一个实施方式的可展开植入物的第二实施例在静止位置的透视图;
图9示出了图8的实例在张开位置的视图;
图10示出了根据图8的实例的侧视图;
图11示出了沿着图10的线III-III的剖视图;
图12示出了沿着图10的线IV-IV的剖视图;
图13示出了沿着图10的线V-V的剖视图;
图14示出了沿着图10的线VI-VI的剖视图;
图15示出了从图8的实例的G方向观看的视图;
图16示出了从图8的实例的上方观看的视图;
图17-29示意性地示出了根据本发明的骨头复原方法的实施例的不同步骤;
图30-32示意性地示出了根据本发明的骨头复原方法的另一个实施例的不同步骤;
图33示出了根据本发明另一个实施例的用于将植入物插入患者骨头的植入物支架装置的透视图;
图34示出了图33的植入物支架装置的俯视图;
图35示出了用于图33和图34中示出的植入物支架的展开量尺;
图36示出了根据使用图33和图34中所示植入物支架用于根据所公开实施例的植入物的展开值图表;
图37示出了根据本发明另一个实施例使用一对植入物的视图。
具体实施方式
图1A至7中所示的可展开植入物1(以及其它实施例)可包括下列部件中一个或多个:
-单个确定展开面2,其可为植入物的固有面;
-装置3,用于将可展开植入物定位在骨头中,使展开面与骨头复原面对应;
-装置4,用于使可展开植入物在单个展开面2中展开;
-装置5,用于控制确定的展开值,该值在植入物所有展开之前的植入物最小厚度A与植入物最大展开之后的最大厚度B之间;以及
-第一相对板6和第二相对板7,在植入物1展开期间,第一相对板6和第二相对板7能够分别沿着单个展开面2在骨头中形成彼此离开的第一支撑面8和第二支撑面9。
如图1A和图1B所示,植入物1可包括具有横向圆形外截面的圆柱形状,可使用车床、激光和/或电蚀刻制造技术(也可使用铸造方法),将生物相容性材料(例如,钛)制成管状体24。植入物1还可包括第一端20和第二端21,各端优选地采用管状体24的横截面的形状。如图1B和图2B所示,这两个端优选地趋向于靠向彼此,以允许植入物的张开/展开。
因此,两端20、21通过第一直线臂22和第二直线臂23彼此相连,其中当植入物未张开时,第一直线臂22和第二直线臂23互相平行。这两个臂可在管状体24中沿纵向形成——即,能够在第一端20和第二端21靠向彼此时被折叠,这也导致第一相对板6和第二相对板7从管状体24的纵轴10的离开。
图2A至2B示出了类似于在图1A和图1B中公开的植入物的实施例,但具有额外一组支撑(例如,四连杆)。更具体地,图2A至2B中的植入物包括支撑13A、13B、14A、14B、15A、15B、16A和16B,上部板和下部板各两对支撑。该额外的支撑可给植入物提供更高的刚度,并且/或者确保板6和7以基本平行和/或均匀的方式张开。
如图4-5所示,为在单个平面2(穿过管状体24的纵轴10)内张开臂22和23,臂22和23优选地沿直径方向相对。在这点上,臂22、23可从管状体24的横向凹槽40形成,该横向凹槽40横越贯穿管状体,在植入物1的两个端20和21之间在管状体的整个长度上延伸。如图5所示,连接两端20和21的臂22、23分别采用以管状体24外表面的圆弧26为界的横截面。弦27限定了圆弧26,并且弦27可包括在壁25中以形成凹槽40。凹槽40可关于纵轴10对称。
各臂22、23可分成三个连续的刚性部分,其可如下(例如)连同第一端20和第二端21连接在一起。关于上臂22:第一刚性部分28通过关节29在一端连接到第一端20。刚性部分28的另一端通过关节31连接到相邻的第二刚性部分30的第一端。第二刚性部分30可通过关节33在第二端连接到第三刚性部分32。第三刚性部分32的另一端可通过关节34连接到第二端21。优选地,关节29、31、33和34可以包括一个旋转自由度,分别绕垂直于展开平面2的轴线动作。优选地,关节29、31、33通过在相应的关节区使形成臂的壁的减薄而形成,如图1A-3所示(参见,例如,附图标记5和81)。
当植入物的第一端20和第二端21靠向彼此时,各臂22、23可以张开,使得两个相邻的刚性部分28和32推动中间的刚性部分30远离植入物的纵轴10。如图3更详细示出的,为了在第一端20和第二端21靠向彼此时,使臂的运动沿着正确的方向开始,优选地建立臂各部分的适当的转动力偶。
因此,上臂22的端28、32的刚性部分可分别在形成这些刚性部分的材料腹板的下部铰接到端20和21上。端28、32的刚性部分还可在形成刚性部分28、32的材料腹板的上部中铰接到中间的刚性部分30上。当施加力将第一端20和第二端21沿着植入物的纵轴10靠拢时,关节的移动在端28和32的刚性部分上建立了转动力偶。作为使中间的刚性部分30移动而远离纵轴10的结果,该移动往往使刚性部分32朝着植入物的外部转动。
下臂23可以与上臂相类似的方式构造,并且优选地与上臂22关于穿过纵轴10、垂直于展开面2的平面对称。
这样,根据本发明的一些实施例,上臂22和下臂23的关节优选地由槽81形成的变弱区域形成。所述槽81限定了形成管状体24的材料的薄片条(即,在31、33的材料厚度),薄片条的厚度可由槽81的深度确定(如图中所示),以允许材料的塑性变形而不折断。具体地,根据一个实施例,上臂22的端28和32的刚性部分,以及它们在下臂23上的对称部分,在极限展开期间可采用如下位置(称为极限位置):在该位置中,预定刚性部分在第一端20和第二端21靠向彼此时垂直于植入物1的纵轴10(植入物1张开,直到最大展开能力为止),导致相应的材料产生塑性变形。优选地,预先确定槽81的宽度,以允许上臂和下臂各部分的间隙,还允许向腹板提供合适的曲率半径以确保材料的塑性变形而不使材料破裂。
第一相对板6和第二相对板7可形成在上臂22和下臂23中。关于上臂22,例如,刚性板66可由中间的刚性部分30和从其两侧伸出的材料外延(端部分28和32)形成。为了生成刚性板6,使用一对横向槽35和36将端部分28和32从上臂22分开,其中横向槽35和36纵向地在各自的端部的整个长度上延伸(参见图3-4)。关节31和33与端部分28和32分别形成第一板6的第一支撑12和第二支撑13。根据对称性,同样的方法也适用于第二板7。
因此,根据示出的实施例,第一板6和第二板7可分别包括第一悬臂翼(cantilever wing)16、18和第二悬臂翼17、19,其各自的连接区域位于第一支撑12、14和第二支撑13、15的水平面上。如图1A-3所示,第一悬臂翼16、18和第二悬臂翼17、19可包括基本上相当于第一板6或第二板7中的一个在单个展开面2中最大位移值的长度。
第一板6和第二板7分别形成第一支撑面8和第二支撑面9,各支撑面都具有基本上等于植入物长度的长度,并且在展开期间可以垂直于纵轴10移动。根据本发明的一个实施例,由于植入物1形成在管状体24中,所以第一板6和第二板7分别形成弯曲的支撑面,该弯曲支撑面优选平行于纵轴10。
用于将可展开植入物定位在骨头中以使展开面2与骨头复原面对应的装置3可包括连接装置,该连接装置允许植入物绕着纵轴10的角度定向。例如,该装置可包括平坦表面37、38,该平坦表面37、38形成在端20的具有圆形截面的圆柱形表面上,这样可允许植入物1的转动接合。用于使可展开植入物在单个展开面2中张开的装置4可包括上臂22的端部28和32,以及在下臂23上相应的对称端部,从而允许上部板6和下部板7的张开。
可使用植入物支架71(参见图23)以在将植入物置于骨头内时允许植入物的端20和21彼此靠拢。植入物支架71通过支撑植入物的端20,例如,允许将端21拉向端20,或者反之亦然(例如,支撑端21,将端20推向端21)。为此,远端21,例如,包括沿着纵轴10的螺纹孔39,以允许植入物支架71的接合,其中植入物支架71包括相应的螺纹部分。最接近的端20可包括沿着纵轴10的孔80,以允许有植入物支架71的芯部通到远端21的通路。
可通过植入物支架,优选地借助于螺纹接合来提供控制装置5,从而允许根据需求在任一时刻停止展开,其中植入物支架可包括用于将端20和21靠拢的毫米控制装置。在另一方面,控制装置还可通过臂22和23的关节来提供,更具体地,可通过限定各臂的材料腹板的厚度来提供,在塑性区域变形的各臂允许除弹性收缩之外,展开基本上保持臂的确定的张开位置,其中弹性收缩在实际中可忽略不计。
通过由板得到的板6和7对骨头解剖结构的适应,能够获得植入物的板6和7的展开以及它们张开时的稳定性。虽然在本发明的一些实施例中,板6和7在平行布置中张开,如果必要(例如,根据骨头解剖的需要),本发明的其它实施例允许植入物的板6和7以非平行的移动张开。例如,如果单个的支撑臂的长度不同,那么板6和7的展开可以不平行。例如,如果支撑12和14长于支撑13和15(参见图1A-2B),那么植入物张开会逐渐地推动板6和7使其倾斜远离彼此。在图1A-2B中,这会导致在端21处板6和7比在端20处彼此分离更远。本领域的技术人员应当明白,依据该构造,为获得特定的角,只需要加长/缩短一个相应的支撑的长度。
类似地,如图2A-2C所示,当四连杆包括的支撑12A、12B、13A、13B、14A、14B、15A、15B如图所示一样长度相等时(即,12A长度=13A长度,12B长度=13B长度,等等),结果在植入物展开时产生平行四边形(在段AD与BC之间确保平行性,参见图2C)。通过改变L1和L2的长度,四连杆不会在展开时产生平行四边形,而是在板6和7之间出现角度。形成的角度还可依据端20和21彼此被拉得多近。随着植入物的张开,角度逐渐的增大。
图8-16涉及可展开植入物101的第二实施例,该实施例的元件在功能上与图1-7所示的实施例的相应元件相类似。此外,图8-16中涉及图1-7中所示实施例的相应特征分别包括增加数100的相同的附图标记,并且不再另做描述。
示出的植入物101不同于植入物1在于,在板106和107上没有翼部分,如图9中更加具体示出的。植入物101在各臂122和123的一个端部128或132上包括平行四边形系统141。在示出的实例中,平行四边形系统表示在上臂122的端部128上,连接到端120和下臂123上相应的系统上。平行四边形系统可用来确保各臂122和123的板的移动平行于植入物的纵轴110。如图中所示,臂122的端部128(在相应的臂123上类似)是裂开的,关节131和129(分别)位于中间部分130上方和植入物的端120上方,以形成在相应的板移动期间可变形的平行四边形。
可变形平行四边形141的关节可以与臂122的其它关节131、133、134相同的方式制造,如图8-16所示。如在上面所述和在图11-14中所示,公开的解剖结构在臂的多个部分129、130、132建立了力偶。这在植入物101的端120和121彼此靠拢时,允许期望的位移。
为获得可变形平行四边形141,臂的端部128优选地分为三个纵向杆:两个侧面杆142和一个中间杆143,形成了可变形平行四边形141的两个边。平行四边形其余两个边可由臂122的中间部分的外延144和端120的双重外延145形成,其中外延144位于中间杆143外延的轴线上,双重外延145沿着平行于植入物纵轴110的方向延伸,并置于两个侧面杆142的外延的轴线上(参见图8)。
值得注意,臂122和123可关于通过植入物101纵轴110、基本上垂直于展开面102的平面对称,以在植入物展开期间使得两个板106和107以平行于纵轴110的方式移动。
骨头复原实例
现在参考图17-29,对根据本发明的一个实施例使用可展开植入物复原人骨头的方法的第一实例进行描述。其具体地涉及通过减少裂痕,对通过后外侧线路的椎骨的骨头复原方法。因此,该方法可包括下列步骤中的一个或多个(优选地为全部)。本领域的技术人员应当理解,根据本发明该实施例的植入物挤入/分开骨头内部的组织,使得植入物的支撑面优选地与骨头组织相接触以复原。
(优选地)在(于植入物固有的)单个确定面2内可展开的可展开植入物插入需复原其形状的椎骨60。为实施该操作,由皮肤通过后外侧线路设置杆/销61(例如,Kirschner型销),使得螺纹端62可固定(例如,用螺纹拧紧)进入与被销贯穿的皮质骨(cortical bone)64相对的皮质骨63中(图17)。销61接收在第一扩张管65中,直到第一扩张管65的一端与皮质骨64的外表面接触(例如,可被支撑)(图18。
第一扩张管65由第二扩张管66接收,直到第二扩张管66的端部与皮质骨64的外表面接触(例如,可被支撑)(图19)。第二扩张管再由第三扩张管67接收,该第三扩张管在皮质骨64的外表面上相接触(例如,被支撑)(图20)。第三扩张管67端部的齿68将管固定在皮质骨64中。
如图21所示,然后除去第一扩张管65和第二扩张管66,只留下由管67环绕的销61,其中管67和销61由管状空隙68彼此分离。然后借助于(例如)由销61导向的钻头69穿透最接近的皮质骨64和松质骨70,如图22所示。在一个实施例中,穿透松质骨,直到远端的三分之一(近似地),然后可收回钻头69(销61也可收回)。
植入物最近的一端可拆除地连接到植入物支架71的(优选为)中空芯部的远端上,然后将植入物支架71插入管67的芯部,如图23所示。植入物可通过(例如)螺纹连接可拆除地固定到植入物支架上。在植入物支架71的芯部内,可插入具有远端的杆3316,该杆的远端包括接合植入物远端的接合装置(并且,还可包括直径大于杆直径的展开的近端)。类似于植入物到植入物支架的固定方式,杆到植入物的接合装置也可通过螺纹连接。
如图33所示,植入物支架71包括手柄装置3310,用于控制(例如)杆相对于植入物支架的移动。手柄装置可包括具有中心孔的夹紧块3312,通过该中心孔,植入物支架71被固定,并至少可转动地,但优选地为可转动地并且线性地,保持在适当位置上。在这点上,夹紧元件的近端与植入物支架的近端优选地为齐平的。根据本发明的一个实施例,手柄3314可连接到夹紧元件和植入物支架中的一个或两个,但优选地能够相对于它们在顺时针和逆时针方向中的一个或两个上自由转动。在本发明的另一个实施例中,手柄可不连接到夹紧块和植入物支架中的一个或两个。该手柄可包括中心孔,该中心孔优选地包括预定螺距的内部螺纹。
接收在植入物支架内的杆3316优选地包括在螺距上相当于手柄3314的螺距的螺纹。锁止装置3311相对于夹紧块滑动,并且可包括销3321,销3321与杆3316摩擦地干涉,以将杆锁定在位置上(即,不能转动运动)。
优选地至少沿着大部分杆长度设置杆螺纹。根据本发明的一个实施例,可预先组装杆、植入物支架、夹紧块和手柄。将杆的带螺纹远端插入植入物近端中心内的孔中,然后杆带螺纹的远端可接收在植入物远端中心内相应的螺纹部分中。然后,可将植入物与植入物支架/手柄装置组件的远端(即,植入物的所在位置)插入扩张管67。
图34示出了植入物支架的另一个视图,包括可用来表示植入物展开量的量尺3320(例如,测定在杆3316上的转动量)。量尺可包括对杆3316的观察孔。如图35所示,根据本发明的一个实施例,能看见的杆的部分可不包括螺纹。并且,杆的该部分可包括表示展开百分比的标记3322。与观察孔相邻设置的另外的标记3324允许使用者从两个标记之间的相对移动来测定展开百分比。
依赖于杆3316的预定螺距和螺纹方向,手柄的转动使杆3316相对于植入物支架沿一方向线性运动。优选地,螺纹设置在杆上,使得手柄的顺时针运动将杆从植入物展开的区域(植入区域)向外运动离开。例如,对于M5螺纹,可使用0.8mm的螺距。但是,本领域的技术人员应当理解,(例如)可使用大约0.5mm与1.0mm之间的螺距。图36为通过用于三种特定尺寸植入物的杆的转数示出根据本发明的一个实施例的植入物无负载展开的图表。
因此,考虑到上面的实施例,一旦植入物固定在扩张管中并在其中向下滑动,那么就使得植入物置入椎骨60的内部。优选地定位该植入物,使得单个展开面2对应于所需的骨头复原面(图24)。可使用任意成像技术,包括X光和超声波,来校验植入物的位置。
然后转动手柄3314,将杆从植入区域“拉”离。由于植入物的近端接靠在植入物支架上,所以拉动杆会引起植入物的远端向着近端移动(或者,反之亦然)。这导致植入物的端部彼此拉伸,使植入物张开。更具体地,相对板6和7张开,有利地分别在椎骨60中形成第一支撑面8和第二支撑面9,这两个支撑面可在基本上等于植入物1长度的整个长度上连续(图25)。在展开期间,进行减少骨裂的控制。
因此,通过在板下方支撑,允许推力在植入物下方的板的整个长度上分配,从而在椎骨中得到植入物的展开。因此,可设置板的足够长度,而限制板厚度的过多尺寸以阻止弯曲。本领域的技术人员应当理解,根据本发明一些实施例的植入物采用了升降板的长度(非展开)对长度的空间需求比(被极度优化),例如,从而允许以减少骨裂为目的在有限骨内空间的更好应用。
根据本发明的实施例,杆3316还可包括分离装置,其可在杆的近端3318上包括内六边形。这可允许一旦植入物已经张开,就将杆从植入物分离。可选择地,在手柄未连接到夹紧块和/或植入物支架的情况下,手柄可反方向转动(即,转动使得杆不沿着远离植入物的方向移动),使得手柄行进远离夹紧块与植入物支架的齐平部分,从而手柄接合了杆的近端。手柄的进一步反方向转动(在植入物张开后)使杆以与手柄相同的反方向转动,因此引起杆与植入物分离。依赖于确定的螺距,该分离可在任意转数发生(例如,少于或多于一转)。还是参见图26。
优选地,在移除杆之后,将填充材料74注射到植入物周围。以填充植入物内部和周围为目的,填充材料可包括,例如,离子粘固粉,尤其是磷酸钙粘固粉、炳烯酸类粘固粉或后者的混合物。为达到该目的,注射器73的针在管67中向下滑动,直到针的端部达到植入物1的远端孔39为止(图27)。然后通过针注射填充材料。持续注射可以倒退方式进行到椎骨60的近端孔64(图28)。然后从管67退出注射器的针(图29)。
现在参考图30-32,对根据本发明用于复原人骨头的实施例的方法的第二实例进行描述。该实例一般涉及减少骨裂,使用通过椎弓根线路对椎骨骨头复原的方法。
第二实例与第一实例类似,只是植入物插入椎骨60的线路不同,其现在以椎弓根的方式(图30)代替在第一方法中使用的后外侧线路得到。因此,在图30-32中只示出了第二方法的一些步骤,以显示出用于将植入物1插入椎骨的不同线路。对于图30至图32,与第一方法实例相同的元件具有相同的附图标记,那些图分别对应于第一方法实例的图24、25和28的步骤。关于图32所示的步骤,后者在注射器73的针头位置上与图28稍微不同,更接近于图32中植入物的远端。
这样,可以看出,已经清楚达到上文阐明本发明的目的。由于无需脱离本发明的范围就能做出一定的变化,因此,上述说明和在附图中所示的所有内容都只是示意性的,而不是字面意见的(并因此不是限制性的)。本领域的技术人员会认识到本文描述与说明的方法、装置和系统构造都只是落入本发明范围的多种可能系统构造的实例。
Claims (17)
1.一种用于骨头复原的可展开植入物,包括:
植入物固有的单个展开面,其中所述单个展开面对应于骨头复原面;
第一相对板和第二相对板,其分别形成第一骨头支撑面和第二骨头支撑面,其中在所述植入物展开时,所述第一相对板和第二相对板趋向于沿所述单个展开面移动远离彼此;
第一支撑和第二支撑,用于所述第一支撑面和所述第二支撑面中的每一个,分别位于各板的下方;以及
用于控制所述植入物的展开的装置,该装置包括设置在各支撑与对应的板之间的材料腹板,所述材料腹板具有控制所述植入物的展开的确定厚度。
2.如权利要求1所述的可展开植入物,还包括与各材料腹板相邻定位的槽,其具有确定的宽度,以允许各支撑与各自的板之间的间隙。
3.如权利要求1所述的可展开植入物,其中各支撑的长度基本上彼此相等。
4.如权利要求1所述的可展开植入物,其中至少一个所述板的至少一个所述支撑的长度短于相应的第二支撑,使得在所述植入物展开时,所述第一板和所述第二板彼此成一定角度地运动。
5.如权利要求1所述的可展开植入物,其中所述第一支撑和所述第二支撑包括一对第一支撑和第二支撑。
6.一种用于将可展开植入物插入患者体内的医用插入装置,包括:
夹紧部分,具有中心孔;
第一管,容纳在所述中心孔中;
螺纹杆,容纳在所述第一管中,具有接收用于插入患者体内的植入物的远端;
手柄,连接到所述夹紧部分和/或植入物支架;以及
量尺,用于确定所述植入物的展开。
7.如权利要求6所述的装置,其中所述夹紧部分的近端与所述第一管的近端齐平。
8.如权利要求6所述的装置,其中所述手柄连接到所述夹紧部分和所述第一管中一个或两个的近端。
9.如权利要求8所述的装置,其中所述手柄能相对于所述夹紧部分和/或所述第一管自由转动。
10.如权利要求6所述的装置,其中所述手柄包括具有螺纹的开孔,该开孔的螺纹的螺距相当于所述螺纹杆的螺距。
11.如权利要求6所述的装置,其中所述量尺包括在所述夹紧部分中的开孔,用于观测所述螺纹杆的部分。
12.如权利要求11所述的装置,还包括第一标记和第二标记,所述第一标记与所述观察孔相邻,所述第二标记设置在螺纹杆显示于所述观察孔中的部分上,其中所述螺纹杆的转动导致所述第一标记与所述第二标记的相对运动。
13.如权利要求6所述的装置,还包括锁止装置,以基本上停止所述螺纹杆的转动。
14.一种骨头还原的系统,包括:
至少一个可展开植入物,具有对应于骨头复原面的单个展开面;
第一管,用于定位与要复原的骨头的外表面相邻;
第一杆,具有用于固定进所述骨头内部远端中的螺纹端,所述第一杆接收在所述第一管内;
第二管,用于在其中接收所述第一管;
第三管,用于接收所述第二管,所述第三管包括用于在所述骨头外表面上固定所述第三管的一个或多个连接元件;
钻头,用于在所述骨头的一侧开设扩大的孔,其中所述外头由所述第一杆导向;以及
医用插入装置,用于将可展开植入物插入患者体内。
15.如权利要求14所述的系统,其中所述医用插入装置包括:
夹紧部分,具有中心孔;
第四管,容纳在所述中心孔中;
第二杆,容纳在所述第一管中,具有接收用于插入患者体内的植入物的远端,所述第二杆带有螺纹;
手柄,连接到所述夹紧部分和/或植入物支架;以及
量尺,用于确定所述植入物的展开。
16.一种复原人体或动物骨头解剖结构的方法,包括:
将具有单个展开面的可展开植入物插入骨头;
将所述可展开植入物定位在所述骨头中,以使所述单个确定面与骨头复原面相对应;
使所述植入物在所述骨头复原面中展开,其中第一支撑面和第二支撑面展开在所述骨头内的组织;以及
将填充材料注射到所述植入物的周围。
17.如权利要求16所述的方法,其中注射步骤包括注射离子粘固粉。
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2005
- 2005-06-08 FR FR0505798A patent/FR2871367B1/fr active Active
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- 2005-06-08 JP JP2007526606A patent/JP4620120B2/ja active Active
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- 2005-06-08 CA CA2567274A patent/CA2567274C/en active Active
- 2005-06-08 KR KR1020077000205A patent/KR101206552B1/ko active IP Right Grant
- 2005-06-08 ES ES05780621.8T patent/ES2442454T3/es active Active
- 2005-06-08 EP EP12191848.6A patent/EP2572680B1/en active Active
- 2005-06-08 PL PL05780621T patent/PL1778136T4/pl unknown
- 2005-06-08 CN CN201310319755.3A patent/CN103622766B/zh active Active
- 2005-06-08 ES ES12191848.6T patent/ES2576291T3/es active Active
- 2005-06-08 WO PCT/IB2005/002631 patent/WO2005120400A2/en active Application Filing
- 2005-06-08 MX MXPA06014196A patent/MXPA06014196A/es unknown
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2007
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