|Publication number||CN1720010 A|
|Application number||CN 200380104667|
|Publication date||11 Jan 2006|
|Filing date||31 Oct 2003|
|Priority date||5 Nov 2002|
|Also published as||CA2504583A1, CA2504583C, CN102028567A, CN102028567B, EP1562525A1, EP1562525B1, EP2327375A1, EP2327375B1, EP2633835A2, EP2633835A3, EP2633835B1, US7682396, US8267999, US8753397, US9265619, US20060155377, US20090204219, US20130253648, US20140364949, US20160235547, WO2004041129A1|
|Publication number||200380104667.6, CN 1720010 A, CN 1720010A, CN 200380104667, CN-A-1720010, CN1720010 A, CN1720010A, CN200380104667, CN200380104667.6, PCT/2003/4872, PCT/IB/2003/004872, PCT/IB/2003/04872, PCT/IB/3/004872, PCT/IB/3/04872, PCT/IB2003/004872, PCT/IB2003/04872, PCT/IB2003004872, PCT/IB200304872, PCT/IB3/004872, PCT/IB3/04872, PCT/IB3004872, PCT/IB304872|
|Inventors||J·博兰, J-M·菲恩特斯, J-M·维塔尔, T·迪富尔, J·于佩尔|
|Export Citation||BiBTeX, EndNote, RefMan|
|Classifications (32), Legal Events (3)|
|External Links: SIPO, Espacenet|
本发明涉及了一个椎间盘假体，用于在脊柱中，特别是在颈椎上，替代连接椎骨的纤维软骨盘。 The present invention relates to an intervertebral disc prosthesis, used in the spine, particularly in the cervical spine, the vertebrae alternative connecting fibrocartilage disc.
在先前技术中已知有各种假体形式。 In prior art are known various forms of prosthesis. 其中有些假体，由于它们用可压缩材料制成，或由于它们容许假体的不同组成部分相互过度的运动，可能比较容易地引起至少假体的一部分被挤出在椎骨之外，这对病人是不希望的。 Some of these prostheses, because they are made of compressible material or because they allow the different components of the prosthesis mutually excessive movement, may be relatively easily cause at least a portion of the prosthesis is extruded outside the vertebrae, which the patient is undesirable.
本发明的目的是采用一个简单的椎间盘假体，来纠正先前技术的某些缺点，使得可以限制假体不同组成部分相互的运动。 The object of the present invention is the use of a simple intervertebral disc prosthesis, to correct some of the shortcomings of the prior art, makes it possible to limit the different components of the prosthesis mutual movement.
一个包括至少三个部分的椎间盘假体达到了这个目的，它包括：一个称为上板的第一板、一个称为下板的第二板、以及一个芯子，芯子的上表面与上板的至少一部分下表面接触，芯子的下表面与下板的至少一部分上表面接触，并且上板至少相对于芯子可以运动，特征在于：下板和芯子之间有配合装置，从而沿着基本上平行于下板的轴线，限制或消除了芯子相对于下板的移动，并且环绕基本上垂直于下板的轴线，限制或消除了芯子相对于下板的转动，通过上板和下板的两个平面形成了一个基本上不变的角度。 Comprises at least three parts of the intervertebral disc prosthesis to achieve this object, comprising: a first plate called upper plate, a lower plate is called a second plate, and a core, and on the upper surface of the core At least a portion of the lower plate in surface contact, at least a portion of the core on the lower surface of the lower plate in surface contact, and the upper plate can be moved at least with respect to the core, characterized in that: there are cooperating means between the lower plate and the core, and thus along the the lower plate is substantially parallel to the axis, to limit or eliminate movement of the core relative to the lower plate, and surrounds the lower plate is substantially perpendicular to the axis, to limit or eliminate rotation of the upper plate of the core relative to the lower plate by and two planar lower plate forms a substantially constant angle.
按照另一个特征，下板包括与芯子的凹形装置配合的凸形装置。 According to another feature, the lower plate comprises male means and female means of the core fit.
按照另一个特征，下板包括与芯子的凸形装置配合的凹形装置。 According to another feature, the lower plate comprises female means and male means of the core fit.
按照另一个特征，得到的角度使得芯子沿着从前到后的方向形成一个锐角。 According to another feature, resulting in an angle such that the core forms an acute angle in a direction from front to back.
按照另一个特征，相同的板可以与不同厚度的芯子装配。 According to another feature, the same plates can be assembled with cores of different thicknesses.
按照另一个特征，在上板和下板之间的角度在0°和15°之间。 According to another feature, the angle between the upper and lower plates is between 0 ° and 15 °.
按照另一个特征，芯子可以相对于上板和/或下板运动，使得可以补偿假体的三个部分的相互定位缺陷。 According to another feature, the core relative to the upper plate and / or lower plate movement, makes it possible to compensate for the three parts of the prosthesis of the mutual positioning defects.
按照另一个特征，至少上板下表面的一部分为凹的，并且与芯子的上表面相补。 According to another feature, at least the surface of the upper plate portion is concave, and the upper surface of the core fill.
按照另一个特征，每个凸形装置的尺寸稍小于每个凹形装置的尺寸，从而能够在芯子和下板之间具有微小的间隙。 According to another feature, the size of each male means is slightly smaller than the size of each female means so as to be able to have a slight gap between the core and the lower plate.
按照另一个特征，每个凸形装置的尺寸基本上相同于每个凹形装置的尺寸，从而防止在芯子和下板之间的任何间隙。 According to another feature, the size of each male means are substantially the same as the size of each female means so as to prevent any clearance between the core and the lower plate.
按照另一个特征，下板的凸形装置是两个扣销，向着假体的内部弯曲，并且相互对着位于假体的两边，以及芯子的凹形装置是两个凹区。 According to another feature, the male means of the lower plate are two snap pin, bent toward the inside of the prosthesis and located opposite each other on either side of the prosthesis, and the female means of the core are two recessed areas.
按照另一个特征，至少一个扣销被一个设有钻孔的凸耳替代，采用进入钻孔的一个销钉把一个舌片固定在凸耳上。 According to another feature, at least one of a snap pin is provided with projecting ears borehole alternative, use of a pin into the borehole to a tongue fixed to the lugs.
按照另一个特征，下板的凸形装置是两个位于下板中心附近的销钉，芯子的凹形装置是两个凹坑。 According to another feature, the male means of the lower plate of the lower plate are two located near the center of the pin, the female means of the core are two recesses.
按照另一个特征，下板的凸形装置是相互对着位于假体两边附近的两个壁，芯子的凹形装置是凹区。 According to another feature, the male means of the lower plate are located opposite each other on either side of the prosthesis close to the two walls, the female means of the core are recessed area.
按照另一个特征，下板的凸形装置是位于假体中心的一个肋，芯子的凹形装置是一个槽。 According to another feature, the male means of the lower plate is a rib located in the center of the prosthesis, the core means is a concave groove.
按照另一个特征，芯子由聚乙烯制成。 According to another feature, the core is made of polyethylene.
按照另一个特征，下板在其前边附近包括一个或几个开孔，用于在一个椎骨中容纳假体固定装置。 According to another feature, the lower plate in the vicinity of the front side comprises one or several openings for receiving the prosthesis securing means in a vertebra.
按照另一个特征，下板的开孔为矩形，固定装置包括一个与下板形成锐角的本体和一个头部。 According to another feature, the lower plate is a rectangular opening, forms an acute angle fixing means comprises a body and a head portion of the lower plate.
按照另一个特征，下板的开孔为圆形，固定装置为钉子形。 According to another feature, the lower plate having a circular opening, fixing means for the nail-shaped.
按照另一个特征，上板至少在其上表面的一部分上为凸形，以配合椎骨的形状。 According to another feature, the upper plate, at least on part of its upper surface is convex, to match the shape of the vertebrae.
在参照附图、阅读以下的描述之后，对本发明的其他特征和优点将会看得更清楚，其中：图1a和1b分别代表了一个实施例的上板的底视图和底透视图，图2a和2b分别代表了一个实施例的下板的顶视图和顶透视图，图3a和3b分别代表了一个实施例的芯子的顶视图和顶透视图， After referring to the drawings, reading the following description, features and other advantages of the invention will be seen more clearly, in which: Figures 1a and 1b represent respectively a bottom view and a bottom perspective view of the upper plate of one embodiment, FIG. 2a and 2b respectively represent a top view and a top perspective view of the lower plate of an embodiment, FIG. 3a and 3b respectively represent a top view and a top perspective view of one embodiment of the core,
图4a和4b分别代表了图1a，1b，2a，2b，3a和3b实施例的椎间盘假体的顶透视图和侧视图，图5a和5b分别代表了第二个实施例的椎间盘假体的侧视图和沿着图5a平面DD的剖视图，图6a代表了第三个实施例的椎间盘假体的侧视图，图6b和6d代表了沿着图6a平面AA的剖视图，芯子相对于下板分别具有微小间隙和不具有间隙，图6c和6e分别代表了沿着图6b和6d平面BB的椎间盘的剖视图，图7a和8a分别代表了另外两个实施例的下板的顶视图和底透视图，图7b和8b分别代表了图7a和8a下板的侧透视图和顶透视图，其中按照两个不同实施例插入了假体固定装置，图9a代表了第四个实施例的下板的顶视图，图9b代表了沿着图9a平面CC的下板的剖视图，图10a和10b分别代表了另一个实施例的上板的后视图和侧视图。 Figures 4a and 4b represent the FIG. 1a, 1b, 2a, top perspective view of 2b, 3a and 3b, an embodiment of the intervertebral disc prosthesis and a side view, Figures 5a and 5b represent a second embodiment of the intervertebral disc prosthesis a side view and a sectional view along the plane DD in Figure 5a, Figure 6a represent a third embodiment of the intervertebral disc prosthesis is a side view, Fig. 6b and 6d represent a sectional view taken along the plane AA of Figure 6a, the core relative to the lower plate respectively, with a slight gap and without gaps, Fig. 6c and 6e represent a sectional view of FIG. 6b and 6d of the disc along the plane BB, Fig. 7a and 8a respectively represent a top view and a bottom perspective view of the lower plate of the two embodiments diagram, Figure 7b and 8b respectively represent a side perspective view and Fig. 7a and 8a a top perspective view of the lower plate, wherein the insert according to two different embodiments of a prosthesis fixture, Figure 9a represents a fourth embodiment of the lower plate The top view, FIG. 9b represents a sectional view of the lower plate of Figure 9a along the plane CC, Figures 10a and 10b respectively represent the upper plate of another embodiment of a rear view and a side view.
本发明的椎间盘假体由一个上板1构成，它依靠一个芯子3相对于一个下板形成关节式连接，如在图4a，4b，5a和6a中可以明显看出。 The intervertebral disc prosthesis of the present invention is constituted by an upper plate 1, it relies on a core (3) with respect to a lower plate forming the articulation, as in Fig. 4a, 4b, 5a and 6a will be apparent. 本发明假体的一个优点是它包括了简单的部分，可以设计成使得假体配装在颈椎上。 An advantage of the present prosthesis is that it comprises simple parts, can be designed such that the prosthesis is fitted on the cervical spine.
在图1a和1b中可以明显看出，上板1至少在其下表面的一部分10上稍凹，从而与芯子3的稍凸的上表面配合。 In Figures 1a and 1b will be apparent, the upper plate 1 at least slightly concave upper surface at its lower portion 10, so that the core 3 is slightly convex upper surface mating. 芯子3的上表面与上板1的凹形部分10相补，使得能够在上板1和芯子3之间运动。 The upper surface of the core 3 and the concave portion 10 on the plate 1 complementarity, enables the upper plate 1 and between the core (3) movement.
在一个供替代的实施例中，上板1上表面的一部分为凸形，如图10a和10b所示，以便更好地配合在要配装假体的椎骨上，椎骨的底部是凹的，此时，上板1的凸形部分位于上板的前部，如在图10b中可明显看出。 In the embodiment of an alternate embodiment, the upper portion of the surface of the upper plate 1 is convex, as shown in Fig. 10a and 10b, in order to better fit the body of the vertebra to pretend with bottom vertebrae is concave, At this time, the convex portion 1 of the upper plate portion located on the front panel, as can be clearly seen in Figure 10b.
下板2基本上为平的。 The lower plate 2 is substantially flat. 实际上，其下表面不需要凸或凹，因为椎骨顶部基本上是平的。 In fact, its lower surface does not need a convex or concave since the top of the vertebrae is substantially flat. 在图2a，2b，7a和8a的实施例中，在下板2的两个基本上平行的边21、22上，下板2包括两个位置相互对着的扣销20。 In Figure 2a, 2b, 7a and 8a of the embodiments, the two sides 21, 22 of the lower plate 2 is substantially parallel to the lower plate 2 comprises two mutually opposing positions of the snap pin 20. 每个扣销20向着假体内部弯曲，因此可以进入位于芯子3上的凹区30。 Each buckle pin 20 toward the inside bend of the prosthesis, so you can enter the core pits located on 30 3. 在图3a和3b中可明显看出，芯子3包括一个基本上平的下表面。 As is apparent in Figures 3a and 3b can, core 3 comprises a substantially flat lower surface. 用于配合在下板2上。 For engaging the lower plate 2. 对于颈椎假体，芯子3较薄(例如3mm厚)，或者对于腰椎假体较厚(例如15mm)。 For cervical prosthesis core 3 thin (3mm thick for example), or for a lumbar prosthesis thicker (eg 15mm).
在图3a，3b，4a和4b的实施例中，芯子3的每个凹区30尺寸稍大于下板2的每个扣销20尺寸，从而沿着基本上平行于下板2的轴线的移动，以及环绕基本上垂直于下板2的轴线的转动，均限制了芯子3相对于下板2的间隙。 In Figure 3a, 3b, 4a and 4b of the embodiment, each recessed area 30 of the core 3 is slightly larger than the size of the lower plate 20 of each size of the snap pin 2, thus along the lower plate 2 is substantially parallel to the axis of move, and the vertical axis of rotation substantially surround the lower plate 2, both limits of the core 3 relative to the lower plate 2 of the gap. 上板1和芯子3之间的运动，以及芯子3相对于下板2的间隙，使得病人能够运动，并且如果需要，可以补偿假体定位的缺陷。 1 and the movement between the upper plate of the core 3, and the core 3 with respect to the gap between the lower plate 2, so that the patient can be moved, and, if desired, can be compensated for the prosthesis positioning defects. 间隙也提供了一个优点，防止作用于假体上应力造成过早磨损。 Gap also provides an advantage to prevent the stress acting on the prosthesis cause premature wear.
在图5a和5b的实施例中，芯子3的每个凹区30的尺寸基本上与下板2的每个扣销20尺寸相同，从而在移动和转动上，均防止芯子3相对于下板2的任何间隙。 In the embodiment of FIG. 5a and 5b, the size of each recessed area 30 of the core 3 is substantially the lower plate 20 of each snap pin 2 of the same size, so that the moving and rotating, with respect both to prevent the core (3) The lower plate 2 of any gap. 此时，容许假体的唯一运动是上板1相对于芯子3的运动。 At this time, the only movement of the prosthesis is to allow the upper plate 1 with respect to the movement of the core 3.
在9a和9b的实施例中，扣销20之一用一个设有钻孔200的凸耳替代。 In an embodiment of 9a and 9b in one of 20 with a pin buckle with bay drilled 200 ear instead. 用一个进入钻孔200的销钉24把一个舌片23固定在凸耳上。 Into the borehole 200 by a pin 24 on a tongue 23 fixed to the lugs. 在一个供替代的实施例中，两个扣销均用固定了舌片23的凸耳替代。 In the embodiment of an alternate embodiment, the two pins are made of fixing the buckle tongues 23 projecting ears instead.
在图6a，6b，6c，6d和6e的实施例中，下板2不包括任何扣销20，而包括位于下板2中心附近的两个销钉25。 In Figure 6a, 6b, 6c, 6d and 6e in the embodiment, the lower plate 2 does not include any deduction pin 20, and includes a lower plate 2 located near the center of the two pins 25. 此时，作为相补，芯子3不包括任何凹区30，而在其下表面包括两个凹坑35。 In this case, as the fill phase, the core 3 does not include any concave region 30, and at its lower surface comprises two recesses 35. 下板2的销钉25尺寸和芯子3的凹坑35尺寸，在图6b和6c实施例中容许有微小的移动和转动间隙，在图6d和6e实施例中不容许有间隙。 Pin 25 of the lower plate 2 of size 35 and size of the pit 3 of the core, in Figure 6b and 6c embodiments allow a slight movement and rotation gap, in FIG. 6d and 6e embodiment does not allow a gap.
在图中未示的另一个实施例中，下板2在其上表面上包括一个肋，没有扣销20或销钉25。 Not shown in the figure of another embodiment, the lower plate 2 on its upper surface includes a rib, the pin 20 does not buckle or pin 25. 作为相补，芯子3在其下表面包括一个槽。 As complementarity, core 3 comprises a groove in its lower surface. 下板的肋尺寸和芯子的槽尺寸，在一个实施例中容许有微小的移动和转动间隙，在另一个实施例中不容许有间隙。 The size of the lower plate and the core of the rib groove size, in one embodiment, to allow a slight movement and rotation gap, in another embodiment does not allow a gap.
在图中未示的另一个实施例中，替代扣销20，下板2包括两个壁，相互对着设置在下板的两个基本上平行的边21，22附近，它们设置在假体内，但不是扣销20。 Not shown in the figure of another embodiment, instead of the snap pin 20, the lower plate 2 comprises two walls disposed opposite each other near the lower edges 21, 22 of two substantially parallel plates, which are provided in the false body , but not snap pin 20. 芯子3包括相对于壁的相补凹区。 Including with respect to the core (3) relative to fill the pit wall. 在该实施例中，芯子的每个凹区尺寸稍大于，或者基本上等于下板的每个壁尺寸，从而使得能够有或没有微小的移动和转动间隙。 In this embodiment, the core of each of the recessed area slightly larger than, or substantially equal to the dimensions of each wall of the lower plate, thus making it possible to have a slight or no movement and running clearance.
在图中未示的另一个实施例中，凹形装置位于下板和凸形装置位于芯子。 In another not shown embodiment, the female means located in the lower plate and the male means located in the core.
本发明的椎间盘假体可以纠正脊椎前凸的缺陷和对脊椎，例如对颈椎增加脊椎前凸。 The intervertebral disc prosthesis of the invention can correct lordosis defects and to the spine, such as cervical increase lordosis. 因此，沿着图4的从前到后的方向F，在假体的上板1和下板2之间，需要存在一个锐角。 Therefore, the direction from the front to the rear in Figure 4 F, between the upper plate 1 and the lower prosthesis plate 2, require the presence of an acute angle. 例如，这个角度在0°到15°之间。 For example, this angle is between 0 ° to 15 °. 为了根据病人来调整所需的角度，简单地需要选择一个芯子，在代表其上表面的中面和通过其下表面的平面之间具有一个适当的角度。 Based on the patient in order to adjust the desired angle, simply need to select a core, on behalf of its upper surface in the surface and having an appropriate angle between the plane passing through its lower surface.
如果凹形件位于下板和凸形件位于芯子，则依靠进入下板空腔或开孔的一个突起，沿从前向后的方向形成一个锐角的脊椎前凸芯子可以与板成为整体。 If the female member is located in the lower plate and the male member is located in the core, rely on the next cavity or opening of a plate projection, formed in the rearward direction from the front at an acute angle of lordosis core may be integral with the plate.
当上述芯子为平时依靠上板的形状，或者当上述芯子为凸时依靠上板相对于芯子的位置，可以得到先前技术中已知的假体倾角。 When the shape of said core is usually rely on the board, or rely on the plate relative to the position of the core when said core is convex, can be known in the prior art prosthesis inclination. 对于上述先前技术的第一种情形，本发明假体的机加工更加经济，因为芯子用比板更便宜的材料(例如，聚乙烯)组成。 For the above-mentioned prior art first scenario, the present invention is the machining of the prosthesis is more economical, because the composition of the core with a cheaper material than the plates (e.g., polyethylene). 对于上述先前技术的第二种情形，本发明的芯子不容易被挤出假体之外，因为板之间的角度在假体定位时基本上不变。 For the second scenario above prior art, the core of the present invention does not readily be extruded outside the prosthesis since the angle between the plates when the prosthesis is positioned substantially constant.
如果外科医生需要一个病人的确定的脊椎前凸，则他们将选择一个相对于下板2不容许有间隙的芯子3。 If the surgeon needs to determine the lordosis of a patient, they will select a with respect to the lower plate 2 does not allow a gap of the core 3. 另一方面，如果他们简单地需要脊椎前凸保持在一定范围值内，则他们将选择一个相对于下板2容许微小移动和转动间隙的芯子。 On the other hand, if they simply need lordosis maintained within a certain range of values, they will select a with respect to the lower plate 2 and to allow a slight rotational movement of the core gap.
在图7a，7b，8a和8b中代表的一个供替代的实施例中，本发明的椎间盘假体可以固定在脊椎中，防止在脊椎对定位假体施加的横向合力(它随着脊椎前凸而增加)影响下假体移位。 In Figure 7a, 7b, 8a and 8b in the embodiment represented a substitute for, the intervertebral disc prosthesis of the invention can be fixed in the spine, preventing lateral force (which along with lordosis in the spine of the positioning of the prosthesis applied increase) under the influence of prosthesis displacement. 此时，下板2包括位于假体后侧边附近的一个或几个开孔28，29，使得可以容纳固定装置4，5。 In this case, the lower plate 2 comprises one or several openings located near the side of the prosthesis after 28, 29, making it possible to accommodate securing means 4,5.
这样，在图7a和7b情形中，下板2的开孔28为矩形，固定装置4由一个本体40和一个头部41构成。 Thus, in the case of Figures 7a and 7b, the opening 2 of the lower plate 28 is rectangular, the fixing means 4 consists of a body 40 and a head portion 41 configured. 头部41的尺寸稍大于下板2的开孔28的尺寸，使得一旦固定装置4在一个椎骨中定位时，下板2夹在固定装置4的头部41和上述椎骨之间。 Size of the head 41 is slightly larger than the opening 28 of the lower plate 2, such that once the fixing apparatus 4 is positioned in a vertebra, the lower plate 2 is sandwiched between the fixing device 41 of the head 4 and said vertebra. 在固定装置4的本体40和下板2之间具有一个小于或等于90°的角度。 Between the fixing means 40 of the main body 4 and the lower plate 2 having a value less than or equal to 90 ° angle.
在图8a和8b的情形中，在下板2中具有两个圆形开孔29，固定装置5为钉子形，具有一个比开孔29尺寸大的头部，使得可以把下板2夹在固定装置5的头部和固定假体的椎骨之间。 In the case of Figures 8a and 8b, the lower plate 2 having two circular openings 29, fixing means 5 is a nail shape having a size larger than the head opening 29, so that the lower plate 2 can be sandwiched between the fixed between the vertebrae of the head unit 5 and the fixed prosthesis.
对于熟悉该技术的人员应该清楚，本发明能够形成无数其他具体形式的实施例而不偏离如权利要求中规定的范围。 For a person skilled in the art will be clear, embodiments of the present invention can be formed in numerous other specific forms without departing from the scope as defined in the claims. 因此，必须认为本实施例仅是举例说明，而可以在所附权利要求范围规定的领域中修改，并且本发明不一定限于以上给出的细节。 Therefore, the present examples are to be considered illustrative, but can be modified in the scope of the appended claims predetermined field, and the present invention is not necessarily limited to the details given above.
|International Classification||A61B17/064, A61F2/44, A61F2/30, A61F2/00|
|Cooperative Classification||A61F2220/0008, A61F2220/0033, A61F2002/30841, A61B2017/0647, A61F2002/30884, A61F2/442, A61B17/0642, A61F2002/30398, A61B17/0644, A61F2002/30616, A61F2002/0882, A61F2220/0025, A61F2002/30472, A61F2002/30662, A61F2220/0041, A61F2002/30535, A61F2002/30393, A61F2002/30576, A61F2/0811, A61F2002/30397, A61F2002/30354, A61F2002/30365, A61F2220/0016, A61F2002/30369, A61F2002/443, A61F2/4425|
|European Classification||A61F2/44D2, A61F2/44D|
|11 Jan 2006||C06||Publication|
|1 Mar 2006||C10||Entry into substantive examination|
|11 Apr 2012||C12||Rejection of a patent application after its publication|