Abstract:
A bone anchoring device includes a bone anchoring element having a shank and a head, a continuous one-piece receiver member, a continuous one-piece first locking element and a second locking element. The receiver member has a first chamber for receiving the head, the head being pivotable in the first chamber, and a second chamber with a channel for receiving the rod. A first locking element fixes the head in the first chamber at an angle, and a second locking element fixes the rod in the second chamber. The receiver member includes a body including both the first chamber and the second chamber. The head and the rod can be inserted and locked independently from each other. The head is fixed by exerting pressure onto it. The bone anchoring device is particularly applicable to the stabilization of the spine in the sacro-iliac and the cervical region.

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
       [0001]    This present application claims the benefit of U.S. Provisional Patent Application No. 61/229,061, filed Jul. 28, 2009, and claims priority from European Patent Application EP 09 166 639.6, filed Jul. 28, 2009, the disclosures of which are incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    The invention relates to a bone anchoring device with a bone anchoring element having a shank and a head and a receiver member for receiving the head and for receiving a rod. The bone anchoring element is pivotable in the receiver member and can be locked by a first locking element. The rod can be locked by a second locking element which is separated and independent from the first locking element. The bone anchoring device is particularly applicable for the stabilization of the cervical or the lumbosacral region of the spinal column. 
         [0003]      FIG. 1  shows different zones of the spinal column in a side view. In  FIG. 2  the lumbosacral region is shown in a posterior view. In this region, it can be advantageous to arrange the stabilization rod offset from the anchoring elements. As depicted in  FIG. 3 , in the stabilization of the iliosacral bones, polyaxial screws  101  with a shank are used that extend at an angle of approximately 90° out of a plane containing the rod axis and a central axis of the receiver member to allow them to be anchored laterally in the ilium  102 . A lateral offset is also helpful in all other junctional zones of the spine. 
         [0004]    Polyaxial bone screws are known in which the rod is arranged above of the head of the bone anchoring element. Usually these polyaxial bone screws have a pressure element which is located between the rod and the head. A locking element, such as a set screw, presses onto the rod that itself presses onto the pressure element to simultaneously lock the head and the rod in their positions. US 2003/0100896 A1 describes a specific example of a polyaxial bone screw that allows the independent fixation of the head and the rod. To accomplish this, a dual part locking element is used, one part of which presses onto the pressure element for fixation of the head and the other part presses onto the rod for fixing the rod. The first and the second locking element are not independent from each other. 
         [0005]    Although the known examples of polyaxial screws are suitable for stabilizing the spine in most of the clinical applications, there is still the need of having a polyaxial screw for specific applications that require the rod to be guided laterally from the screw or the screw extending in a direction out of a plane containing the rod axis. 
         [0006]    US 2007/0265621 describes a polyaxial bone screw that is applicable in particular to the stabilization of the sacrum. 
         [0007]    WO 94/00066 describes an osteosynthetic fixation device that consists of a bone screw having a conical head section and a spherical slotted clamping component that receives the conical head section and that is pivotable in a spherical segment-shaped bore of a connection element. The connection element has a channel for introducing a stabilization rod, and the channel for the rod is provided laterally from the bore that receives the bone screw. Since the clamping component is expanded by the conical head section of the bone screw, it is necessary to have a tension element that draws the conical head section into the clamping element. Therefore, on top of the conical head section of the bone, screw sufficient space must be provided for the tension element. 
         [0008]    U.S. Pat. No. 6,290,703 B1 describes a bone fixing device in particular for fixing to the sacrum for osteosynthesis of the backbone. The device comprises an elongate link that receives at least one bone-fastening screw that passes through an orifice formed in the link. In the bottom of the link there is a bearing surface of essentially circular cross-section. The head of the screw includes an essentially spherical surface for bearing against the bearing surface. The device further includes a plug suitable for coming into clamping contact against said screw head to hold it in a desired angular position. 
         [0009]    U.S. Pat. No. 7,166,109 B2 describes a bone anchoring device comprising a bone screw and a receiver member with a lateral channel for the rod. The receiver member is a two-part receiver member. The device has a low profile and is particularly applicable to the stabilization of the pelvis. 
         [0010]    It is the object of the invention to provide a bone anchoring device that is suitable for many purposes including specific applications such as stabilization of the cervical spine and the sacro-iliac region of the spine. 
       SUMMARY 
       [0011]    The object is solved by a bone anchoring device according to claim  1 . Further developments are given in the dependent claims. 
         [0012]    The bone anchoring device according to the invention has the advantage that the rod and the bone anchoring element can be locked independently from each other with independent locking elements. The locking of the head is possible, for example, by using a single set screw that engages in a standard thread of the head receiving chamber. Since the receiver member is fully threaded, no spreading of the flanks occurs. Therefore, the head can be safely locked with a simple one-part element. Since the locking of the rod and the locking of the bone anchoring element are completely independent, the rod and the bone anchoring element can be locked and unlocked again independently of each other. This allows easy and precise adjustment of the head and the rod. 
         [0013]    The bone anchoring device has a lower profile than the standard polyaxial screws. The profile is similar in size to a monoaxial screw that has only the receiver, the rod and the locking element. 
         [0014]    Different receiver members can be provided with different orientations of the rod with respect to the bone anchoring element. Therefore, a set of different receivers can be provided to allow the surgeon to select the suitable arrangement. In particular, it is possible to select the lateral offset of the rod with respect to the bone anchoring element. Since the head of the bone anchoring element is easily locked by a simple one-part locking element, the bone anchoring device can be assembled by hand and needs not to be pre-assembled by the manufacturer. This allows the surgeon to select a suitable screw shank and combine it with the receiver member. 
         [0015]    Since all existing screw shanks with heads can be used, the system has an enhanced modularity. 
         [0016]    Further features and advantages of the invention will become apparent from the followed detailed description of embodiments of the invention by means of the accompanying drawings. In the drawings: 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]      FIG. 1  shows a schematic side view of the spinal column with indication of particular regions of the spinal column and particular regions with difficult junctional zones. 
           [0018]      FIG. 2  shows a schematic rear view of the lumbosacral region of the spine. 
           [0019]      FIG. 3  shows a stabilization of the spinal column in the lumbosacral region. 
           [0020]      FIG. 4  shows a perspective view of a first embodiment of the bone anchoring device in an assembled state. 
           [0021]      FIG. 5  shows a perspective exploded view of the bone anchoring device of  FIG. 4 . 
           [0022]      FIG. 6  shows another perspective view of the bone anchoring device of  FIG. 4 . 
           [0023]      FIG. 7  shows a sectional view of the rod receiving portion of the bone anchoring device of  FIG. 6 , the section being taken along line A-A in  FIG. 6 . 
           [0024]      FIG. 8  is a sectional view of the head receiving portion of the bone anchoring device according to  FIG. 6 , the section being taken along line B-B in  FIG. 6 . 
           [0025]      FIG. 9  is a perspective view of the locking element for locking the head. 
           [0026]      FIG. 10  is another perspective view of the locking element of  FIG. 9 . 
           [0027]      FIG. 11  is a sectional view of the locking element of  FIGS. 9 and 10 , the section being taken along line C-C in  FIG. 10 . 
           [0028]      FIG. 12   a  is a perspective view from the top of a modified example of the first embodiment in an assembled state. 
           [0029]      FIG. 12   b  is a perspective view from the bottom of the modified example shown in  FIG. 12   a.    
           [0030]      FIG. 13  shows some possible combinations of different bone anchoring elements with the receiving member and the locking element for locking the head. 
           [0031]      FIG. 14  shows a perspective view of a second embodiment of the bone anchoring device in an assembled state. 
           [0032]      FIG. 15  shows a perspective exploded view of the bone anchoring device of  FIG. 14 . 
           [0033]      FIG. 16  shows a perspective view of the receiver member of the bone anchoring device according to the second embodiment. 
           [0034]      FIG. 17  shows an enlarged sectional view of the head receiving chamber of the receiver member of  FIG. 16 , the section being taken along line D-D in  FIG. 16 . 
           [0035]      FIG. 18  shows a top view of the receiver member of  FIG. 16  seen in the direction of arrow F. 
           [0036]      FIG. 19  shows a side view of the receiver member of  FIG. 16  seen in the direction of arrow H. 
           [0037]      FIG. 20  shows a sectional view of the receiver member of  FIG. 16  the section taken along line D-D. 
           [0038]      FIG. 21  shows a side view of the receiver member of  FIG. 16  seen in the direction of arrow E. 
           [0039]      FIG. 22  shows a schematic view of a modified example of the second embodiment. 
           [0040]      FIG. 23  shows a schematic view of a still further modified example of the second embodiment. 
           [0041]      FIG. 24  shows a still further modified example of the second embodiment. 
       
    
    
     DETAILED DESCRIPTION 
       [0042]    The bone anchoring device  1  according to a first embodiment shown in  FIGS. 4 to 12  includes a bone anchoring element, in this case a screw member  2  having a threaded shaft  3  having a bone thread and a head  4 . The head  4  is shaped, for example, as a spherical segment. It has a recess  4 ′ at its free end for engagement with a screwing-in tool. The bone anchoring device further includes a receiver member  5  for connecting the screw member  2  to a rod  20 . The receiver member  5  includes two portions in the form of separated chambers, a head receiving chamber  6  and a rod receiving chamber  7 . The head receiving chamber  6  and the rod receiving chamber  7  are connected by means of an intermediate portion  8 , which is in the embodiment shown a rod portion or a bar. The head receiving chamber  6  is, as shown in  FIGS. 4 to 6  and  FIG. 8 , a body with a substantially cuboid shape having a first end  6   a  and an opposite second end  6   b.  A through-hole  9  extends from the first end to the second end. In a region adjacent to the second end, the diameter of the through-hole is smaller than that adjacent to the first end. Thus, a seat  9   a  is provided for the screw head  4 , preventing escaping of the screw head and enabling the screw head  4  to pivot within the head receiving chamber  6 . The seat can have a spherical or a tapered portion or a portion with any other shape. Adjacent to or near the first end  6   a,  an internal thread  10  is provided. The internal thread can be a metric thread or can have any other thread shape. Since the thread is provided in the through-hole, the thread is closed in a circumferential direction. This allows use of a metric thread since a splaying of a U-shaped receiver, as it is known to be a problem in conventional polyaxial bone screws, does not occur. The diameter of the opening at the second end  6   b,  which is defined by the through-hole, is such that the shank  3  of the screw member can be passed therethrough. When the head  4  of the screw member  2  is in the head receiving portion, the screw member can pivot so that the shank axis can assume different angles with respect to the axis of the through-hole. 
         [0043]    To fix the angular position of the screw member  2  in the head receiving chamber  6 , a first locking element  11  is provided, which can be seen in detail in  FIGS. 9 to 11 . The first locking element  11  has a threaded portion  11   a  with an external thread cooperating with the internal thread  10  of the through-hole, and a cylindrical portion  11   b,  which extends in the direction of the head  4  when the screw member and the first locking element are inserted into the head receiving chamber. The threaded portion  11   a  and the cylindrical portion  11   b  form a one-part first locking element  11 . At the free end of the cylindrical portion  11   b,  a spherical recess  11   c  is formed, the radius of which is adapted to the radius of the head  4 . The recess  11   c  serves to distribute the load exerted by the first locking element  11  onto the head  4 . The outer diameter of the cylindrical portion  11   b  is slightly smaller than the inner diameter of the through-hole  9  and also of the threaded portion  11   a  so that the first locking element can be easily introduced into the through-hole. The first locking element  11  further comprises a coaxial bore  12  that allows access to the screw head  4  by a tool. At the free end of the threaded portion  11   a,  the first locking element  11  has a structure, such as a hexagonal structure  13  for engagement with a tool. 
         [0044]    Referring to  FIGS. 4 and 8 , the second end  6   b  of the head receiving chamber  6  has an inclined surface that extends at an angle to the surface defined by the first end  6   a.  By means of this, the pivot angle of the screw member can be enlarged to one side. 
         [0045]    As can be seen in  FIGS. 4 to 7 , the rod receiving chamber  7  has also a cuboid shape with a first end  7   a  and an opposite second end  7   b.  A U-shaped recess  14  extends from the first end  7   a  in the direction of the second end  7   b  to form a channel for the rod  20  to be received therein. By means of the U-shaped recess  14 , two free legs are formed. An internal thread  15  extends from the first end or near the first end  7   a  in the direction of the second end  7   b  for screwing in a second locking element  16 . The second locking element  16  is in this embodiment a set screw. The internal thread  15  can be a flat thread with horizontal flanks to eliminate a splaying of the legs when the second locking element  16  is screwed in. 
         [0046]    In the embodiment shown in  FIGS. 4 to 12 , the head receiving chamber  6  and the rod receiving chamber  7  are connected by the intermediate portion  8  and arranged in such a way that the central axis A 1  of the through-hole of the head receiving chamber  6  is inclined by an angle of 45° with respect to the central axis A 2  of the rod receiving chamber  7 , as can be seen in particular in  FIG. 8 . The arrangement of the chambers  6 ,  7  with respect to each other is such that the internal threads of the through-hole and the U-shaped recess, respectively, are oriented towards the same side. By means of this arrangement, as can be seen in  FIG. 8 , it is possible to align the screw axis S nearly parallel to the longitudinal axis L of the rod. By means of the length of the intermediate portion  8 , the lateral offset between the screw and the rod can be defined. 
         [0047]    The shape of the head receiving chamber  6  and the rod receiving chamber  7  is not limited to the cuboid shape shown, it is also possible to use a cube shape, a cylindrical shape or any other symmetric or asymmetric shape. Although the head receiving chamber  6  is shown to be a top loading chamber, where the screw is inserted with its tip portion first through the first end  6   a,  it can also be designed as a bottom loading chamber where the head is introduced from the bottom, i.e. the second end  6   b.    
         [0048]    The material of the elements of the bone anchoring device is a body-compatible material, such as stainless steel, titanium, and body-compatible alloys such as nickel-titanium alloys, for example nitinol. It is also possible to construct the bone anchoring device or parts thereof from a body-compatible plastic material, such as, for example medical-grade PEEK. 
         [0049]    In modifications of this embodiment, the receiver member can be constructed such that the head receiving chamber  6  and the rod receiving chamber  7  have another orientation with respect to each other. Any orientation is possible, for example, an orientation where the central axes A 1  and A 2  are parallel to each other. 
         [0050]    A specific modification of the bone anchoring device according to the first embodiment is shown in  FIGS. 12   a  and  12   b . Like parts are indicated with the same reference numerals as in the first embodiment and the descriptions thereof are not repeated. The bone anchoring device  1 ′ of this modified embodiment has an identical rod receiving chamber  7  and a modified head receiving chamber  6 ′. The head receiving chamber  6 ′ has a through-hole  9  in which the first locking element  11  is screwed in and a seat  91   a  for the head  4  provided at the second end, which is sized such that the head is pivotably held therein. It further includes a recess  91 , which extends in the region near the second end  6   b ′ perpendicular to the through-hole  9  and is open to the second end  6   b ′ and to the through-hole  9 . When the screw member is inserted into the through-hole  9  it can be pivoted once the head  4  is in the seat  91   a  such that the threaded shank extends at an angle of around 90° to the through-hole  9 . In addition, as shown in  FIG. 12   a , the central axes A 1  and A 2  of the head receiving chamber and the rod receiving chamber are parallel in this case and the chambers are arranged such that the locking elements are accessible from the same side. 
         [0051]      FIG. 13  shows a sectional view of the first locking element  11  and a partial sectional view of the head receiving chamber  6  showing the through-hole  9  together with different screw elements. The screw element  2  as shown in the left part of  FIG. 13  can have different shanks  3  with different lengths and diameters. The screw element  2 ′ shown in the middle portion has a coaxial bore  21  extending therethrough from the first end to the tip, providing a channel for the introduction of bone cement or other substances. In another example, the bore  21  is closed at the tip of the shank and can have lateral openings  22  extending from the coaxial bore  21 . In a further modification the screw element  2 ″ can be a screw element for non-spine applications. The screw element  2 ″ has a threaded portion  23  and a thread-free portion  24 . Different screw members  2 ″ with different threads can be provided. The features of the screw elements can be combined among each other. The head  4  of the different screw members  2 ,  2 ′,  2 ″ are all the same with respect to their outer shape and diameter so that they can be assembled with the receiver member described before and clamped with the same locking element  11 . 
         [0052]    In use, first the appropriate screw member and receiver member are selected. Thereafter, the screw member is inserted into the head receiving chamber of the receiver member. Thereafter the screw member is screwed into the bone. Typically, several screw members with receiver members are screwed one after the other into portions of adjacent vertebrae. Then, the angular position of the receiver member with respect to the screw member is adjusted and the first locking element  11  is inserted and tightened to clamp the head. Thus, the head is locked by a downward movement of the first locking element in the direction of the shank. Thereafter, the rod is inserted and is adjusted to the screw position. Thereafter, the rod is fixed by the second locking element. During adjustment of the positions of the rod and the head, it can be necessary to open the head and/or rod fixation again to further adjust the positions. Since the head fixation and the rod fixation are completely independent from each other, a convenient and precise adjustment is possible. 
         [0053]    A second embodiment of the bone anchoring device will now be described with reference to  FIGS. 14 to 24 . The second embodiment differs from the first embodiment in the design of the receiver member  50 . The screw member  2  is identical or similar to that of the first embodiment. Also, different screw members can be used as for the first embodiment. The receiver member  50  has a body having a substantially cuboid shape and the head receiving chamber and the rod receiving chamber are formed by portions of the cuboid body. The body has a first end  50   a  and a second end  50   b,  which can be defined as the short sides  51  of the cuboid. Between the first end  50   a  and the second end  50   b,  walls are defined between the long sides  52  of the cuboid. A central axis C extends through the center of the cuboid body and is parallel to the long sides  52 . Approximately one half of the body, adjacent to the second end  50   b,  forms a head receiving chamber  60  that is constructed by means of a through-hole  90 , the longitudinal axis  90   a  of which extends perpendicular to the central axis C of the cuboid body. The through-hole  90  is shaped similarly to the through-hole  9  of the first embodiment. It comprises an internal thread  100  at one end and a seat  91   a  for receiving the head  4  of the screw member  2  in a pivotable manner at the opposite end. At the first end  50   a,  a U-shaped recess  74  is provided, which forms a channel for receiving the rod  20 . Adjacent to or near the first end  50   a,  an internal thread  150  is provided at the legs formed by the U-shaped recess. The central axis A 2  of the internal thread  150  is coaxial with the central axis C of the body  50  and is perpendicular to the bore axis  90   a  of the through-hole  90 . By means of this arrangement, the rod axis L and the screw axis S include an angle of approximately 90°±α, wherein a is the pivot angle that the screw can assume in the seat. Further, the screw axis S projects out of a plane that contains the rod axis L and the central axis C of the receiver member. This arrangement is particularly suitable for application in the lumbosacral region of the spine as shown in  FIGS. 2 and 3 . 
         [0054]    The first locking element  11  and the second locking element  16  are the same as in the first embodiment. 
         [0055]    The bone anchoring device of the second embodiment can also be used in other regions of the spinal column. If the screw member  2  is screwed into the pedicles, the bone anchoring device is a bone anchoring device with a lateral rod arrangement. Since the body  50  can be a compact design, a low-profile and low-cost bone anchoring device is provided. 
         [0056]      FIGS. 22 to 24  show further modifications of the second embodiment. All modifications have in common a compact body  50 ′,  50 ″,  50 ′″, which has a head receiving chamber  60 ′,  60 ″,  60 ′″ and a rod receiving chamber  70 ′,  70 ″,  70 ′″, which are laterally separated from each other and can be accessed with two separate locking elements  11  and  16 ′,  16 ″,  16 ′″. In  FIG. 22 , the rod receiving chamber  70 ′ is laterally arranged and has an inclined U-shaped recess  74 ′ for introducing the rod  20  from the side and a locking element  16 ′ in form of a set screw to be screwed in a threaded bore  72  extending from the top into the inclined U-shaped recess. This is a side-loading arrangement in which the locking elements  11  and  16 ′ are accessible from the same side. In  FIG. 23 , the U-shaped recess  74 ″ for the rod  20  extends from the same side as the threaded portion  100 ′ of the through-hole  90 ′ for the head  4 . This embodiment is a top-loading embodiment, where the rod has a lateral arrangement and the locking elements for the head and the rod are accessible from the same side.  FIG. 24  shows a further modification, where instead of a U-shaped recess, a through-hole  76  for the rod  20  is provided and the rod is secured by a set screw  16 ′″ extending through a threaded bore  78 . 
         [0057]    The shape of the receiver member of the second embodiment is not limited to the shapes depicted in  FIGS. 14-24 . Common to all modifications is that the receiver member has a body with a compact shape. The head need not be spherically shaped, but can also have a tapered portion or another shape.