Abstract:
A fixation device for bones includes a member which is to be fixed to one or more bones and has at least one bore for receiving a bone screw, wherein the at least one bore comprises a first internal thread portion. The bone screw has a first shaft section provided with a first external thread portion arranged to cooperate with the internal thread portion of the at least one bore, and a head section having a diameter larger than that of the shaft section to provide a catch arranged to engage with a stop formed in the bore. The bone screw further has a second shaft section which includes a clearance groove extending between the catch of the head section and the external thread of the first shaft section. The clearance groove allows disengagement of the two thread portions, such that the bone screw is prevented from being unscrewed off the bore when it is loosened within the adjacent bone. The member can also include a side wall of a cage used in an intervertebral implant device, or can represent a plate of a bone plate assembly.

Description:
RELATED APPLICATION(S) 
       [0001]    The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/952,208, filed Jul. 26, 2007, the contents of which are hereby incorporated by reference in their entirety, and claims priority from European Patent Application EP 07014710.3, filed Jul. 26, 2007, the contents of which are hereby incorporated by reference in their entirety. 
     
    
     BACKGROUND 
       [0002]    The present application relates to a fixation device used to provide a rigid or flexible connection between bones of the human body. 
         [0003]    Document US 2006/0085071 A1 discloses an intervertebral implant device including a body with an upper side, an under side and a front surface, in which four bore holes suited to accommodate respective bone screws are formed. The body may be formed of body-compatible plastic material. To provide rigidity and strength to the device, a small front plate made from a metallic material such as titanium or titanium alloy is attached to the front surface. Four bore holes corresponding in position to the respective bore holes of the plastic body are formed in the front plate. The bone screws may each be inserted through the bore holes of the front plate and then also extend through the bore holes of the plastic body. 
         [0004]    The bore holes of the front plate are provided with internal threads. These internal threads correspond to external threads provided on the respective heads of the bone screws. In order to enable fixation and compression, the threaded heads are conically shaped, thereby tapering towards the shaft sections of the bone screws. 
         [0005]    With regard to such a construction, a problem may arise that the screws may loosen and by application of external forces exerted on the vertebral bodies may slowly be screwed out, which may result in severe damage to adjacent blood vessels, and loosening of the whole implant. For this reason, US 2006/0085071 A1 further proposes to attach a securing plate to the front plate. The securing plate covers respective openings of the bore holes in the front plate and thus secures the bone screws inserted therein. As a consequence, the bone screws cannot be screwed out or fall out. 
         [0006]    The number of parts used to implement the above described intervertebral implant device is large and the dimensions of the device may become disadvantageously large. Further, an additional screwing step has to be applied by the surgeon in order to secure the bone screws against falling out. 
         [0007]    Document EP 1 280 481 A1 shows an intersomatic implant device comprising a cage which is composed of a sidewall. However, the holes or bores provided in the sidewall of the cage are not shown to accommodate bone screws to be inserted therein. 
         [0008]    Based on the foregoing, there is a need to provide an improved intervertebral implant device, which simplifies handling of inserting the device between two vertebral bodies, which increases its stability against external forces once the device has been installed, which also provides an efficient downsizing of the components used and/or which protects the bone screws against being screwed out or falling out in case these are loosened. 
       SUMMARY 
       [0009]    In accordance with aspects of the disclosure, an intervertebral implant device includes a device body having an upper face and a lower face for engaging with an end plate of an upper and a lower vertebral body, respectively, a side wall and at least one bore, which is formed in the side wall for receiving a bone screw as a fixation element to be inserted into vertebral body. 
         [0010]    The bone screw typically has a shaft section with an external thread portion arranged to be anchored in the adjacent vertical body, and a head section which has a diameter larger than that of the shaft section to provide a catch arranged to engage with a stop formed in the bore of the device body. 
         [0011]    The fixation device of the disclosure is arranged to provide a mechanism, which may hold a bone screw as a fixation element in place, which is to be inserted into an adjacent bone such as a vertebral body, even if it is loosened. For this purpose, the shaft of the bone screw has two sections: one section that is provided with the external thread portion and another section that is provided with a clearance groove. 
         [0012]    The external thread portion may engage with the internal thread portion of a bore provided in the device body. The shaft section which includes the clearance portion extends between a head section of the bone screw and the shaft section including the external thread portion. 
         [0013]    Hence, the bone screw may first be screwed into the internal thread portion of the bore using its external thread portion. Then upon further screwing-in of the bone screw, owing to the clearance groove, the external thread portion disengages from the internal thread portion once the entire length in longitudinal direction of the internal thread in the bore of the device body is opposed by the clearance groove. 
         [0014]    However, it becomes further possible to continue rotation of the fixation element by, e.g., an angle of about 90 to about 270 degrees in order to separate the orientation of the thread runout of the external thread of the bone screw with respect to the thread inlet of the internal thread portion of the bore. Thus, even if the bone screw fixed in the bone, e.g., the vertebral body, is loosened with time, the helical projection part of external thread at the position of the thread runout abuts with an end face surrounding the opening of the bore due to this misorientation by, e.g., 90-270 degrees. As a result, the device body urges the bone screw to be held in place within the bone, or vertebral body respectively, in this instance. 
         [0015]    According to an alternative but similar aspect of the invention, the bone screw is provided with a second external thread portion at the head section. This second thread portion cooperates with the internal thread portion, while the first external thread portion, i.e., the bone thread, cooperates with the bone material. A cylindrical guiding portion is formed within the bore adjacent to the internal thread portion in order to receive the head section when the second thread disengages from the internal thread portion in the bore. 
         [0016]    The principles of abutment of the helical projection at the thread runout of second thread are the same as in the first aspect. I.e., after disengaging from the second external thread portion, the projection abuts on a respective end face inside the bore in case of a misorientation of the thread runout by for example 90-270 degrees with regard to the thread inlet of the internal thread portion. Hence, the same degree of protection against fall-out of the bone screw may be achieved as in the first aspect. 
         [0017]    The disclosed fixation device includes a member, which is to be fixed to one or more adjacent bones, and the bone screw as the fixation element. In one embodiment this member may be embodied as a cage employed for connecting adjacent vertebral bodies. 
         [0018]    However, the device is not limited to applications regarding the replacement of intervertebral discs by means of such cages. Rather, according to other embodiments the member may have plate-like, sleeve-like or any other suitable shapes depending on the application, in order to fix or stabilize bones of the spinal column and other areas of the remainder skeleton. 
         [0019]    In accordance with aspects of the disclosure, the disclosed fixation devices include plates for fixing the cervical spine or plates for laterally fixing the thoracolumbar vertebrae using bone screws. 
         [0020]    Further features and advantages of the present fixation device will become apparent and will be best understood by reference of the following detailed description taken in conjunction with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0021]      FIG. 1  shows a perspective exploded view of an intervertebral implant device according to a first embodiment. 
           [0022]      FIG. 2  shows a plan view of the device according to  FIG. 1 . 
           [0023]      FIG. 3  shows a schematic illustration of an insertion process for the device according to  FIG. 1  between two vertebral bodies. 
           [0024]      FIGS. 4A-C  show in a schematic representation in three sectional views steps of inserting a fixation element having a clearance groove into a device body according to a second embodiment. 
           [0025]      FIGS. 5  A-C show in a schematic representation in three sectional views steps of inserting a fixation element having a clearance groove into a device body according to a third embodiment. 
           [0026]      FIGS. 6  A-C show in a schematic representation in three sectional views steps of inserting a fixation element having a clearance groove into a device body according to a first embodiment. 
           [0027]      FIG. 7A  shows a partially enlarged perspective exploded view of the fixation element being inserted into the bore according to the first embodiment, wherein a state of compression prior to locking is achieved. 
           [0028]      FIG. 7B  shows a schematic view of the relative orientations of the thread runout of the external thread of the fixation element and the thread inlet of the internal thread of the bore of the device body as present in the state shown in  FIG. 7A . 
           [0029]      FIG. 8A  shows a partially enlarged perspective exploded view of the fixation element being inserted into the bore according to the first embodiment, in a state after locking, i.e. further rotation by 90-270 degrees. 
           [0030]      FIG. 8B  shows a schematic view of the relative orientations of the thread runout of the external thread of the fixation element and the thread inlet of the internal thread of the bore of the device body with a corresponding misorientation of the thread runout versus the thread inlet resulting from the locking rotation shown in the state of  FIG. 8A . 
           [0031]      FIG. 9  shows a schematic illustration of an alternative embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0032]      FIG. 1  shows in a perspective exploded view a first embodiment of a fixation device according to the present disclosure, which in this instance is a intervertebral implant device  100 . 
         [0033]      FIG. 2  shows a plan view thereof. The device  100  includes a device body  1 , which has the form of a cage. The cage is made of a biocompatible material such as titanium, a titanium alloy or PEEK (polyetheretherketones) and is provided with a substantially vertical sidewall enclosing one or more inner hollow spaces. The spaces are open toward an upper and a lower face  3   a ,  3   b , respectively, of the cage  1 . 
         [0034]    The sidewall of the cage  1  is composed of a front wall  4 , a back wall  5 , a right side wall  6  and a left side wall  7 , which are integrally formed, such that the right and left side wall connect the front and back walls with each other. The front wall  4  represents an anterior wall and the back wall  5  represents a posterior wall of the cage  1 . 
         [0035]    The rigidity of the cage  1  is further stabilized by two inner walls  8 ,  9  which extend in arc-shape from the back wall  5  towards the front wall  4 . Both inner walls are symmetric with respect to the sagittal plane S. 
         [0036]    There are two further inner walls  10 ,  11 , which extend in arc-shape from the back wall towards the right and left side walls  6 ,  7 , respectively. Similar to inner walls  8 ,  9 , both walls  10 ,  11  are symmetric with regard to the sagittal plane. Each of the walls  8  to  11  has an arc-shape that is concave towards the sagittal plane, whereas the left and right side walls  6 ,  7  are convex thereto. This arrangement of side walls and inner walls has been found to provide an optimum load transfer at the cage-bone interface. 
         [0037]    The five spaces defined by the side walls and inner walls are designed to be filled with bone graft material. Further, small teeth  16  are provided on the upper and lower edges of each of the walls, i.e., on the upper face  3   a  and lower face  3   b  of the cage  1 , in order to facilitate a penetration into the end plates of the adjacent vertebral bodies  40 ,  42 . The shape of the series of small teeth directly corresponds to the shape of the walls and is further optimized to anatomically fit to the adjacent vertebral bodies, i.e., good distribution of stress and torsion stability. 
         [0038]    The cage  1  is also provided with three bores  2   a ,  2   b ,  2   c  each for receiving or accommodating a bone screw. The bores  2   a - c  are located on the front wall  4  of the cage  1 , wherein one center bore  2   b  is inclined downward and two side bores  2   a ,  2   c  are inclined upwards. The reverse case may be arranged as well, i.e., the center bore  2   b  is inclined upwards and the two side bores  2   a ,  2   c  are inclined downwards. As can be seen from the top view of  FIG. 2 , the bores  2   a ,  2   c  have each an opening  18   a ,  18   c  respectively towards the upper face  3   a  of the cage  1 . Due to the specific shape and arrangement of the inner walls  8  to  11 , each of the three bores also opens (under respective inclinations with regard to the transversal plane) toward its own distinct inner space confined by these walls  8  to  11 . 
         [0039]    For cages intended to replace intervertebral disks, inclination angles for the bores  2   a - c  of 45°±20° may typically be arranged. For cages intended to function as fixation plates, inclination angles of about 90°±30° can typically be employed. However, the disclosure shall not be limited to the specific values or ranges indicated above. 
         [0040]    The openings  22   a  and  22   c  of the bores are provided in respective end faces  20   a ,  20   c  which form part of inclined inner surfaces of the front wall  4  towards the inner spaces of the cage  1 . The end faces  20   a ,  20   c  are oriented substantially perpendicular to respective longitudinal axes of the bores  2   a - c . As will be detailed below, the end faces form an abutment area for projecting parts of thread runouts towards a clearance groove formed on the bone screws  30   a  to  30   c.    
         [0041]      FIGS. 3A and 3B  illustrate the insertion of the cage  1  between two adjacent vertebral bodies  40 ,  42 . For this purpose a holding slot  14  is provided on either side of the cage  1 , i.e., within the right side wall  6  and the left side wall  7 . The holding slot  14  is elongated and extends in the transversal plane T of the cage  1 . The slot allows engagement by a holding instrument which facilitates insertion of the cage  1 . In this embodiment the cage  1  represents an anterior lumbar interbody fusion cage (ALIF-cage), wherein the cage is to be introduced between two adjacent vertebrae of the lumbar spinal column from the anterior direction in order to replace a spinal disc, for example. 
         [0042]    Once the cage  1  is appropriately positioned between the vertebral bodies  40 ,  42 , bone screws  30   a - c  are inserted in respective bores  2   a - c  and screwed into end plates of the vertebral bodies  40 ,  42  ( FIG. 3B ). For explanation purposes, a simplified construction of the bores  2 ′ and the corresponding bone screws  30 ′ is shown in the embodiment of  FIGS. 4A-C . Like numerals denote the same or similar components in the figures. 
         [0043]    The bone screw  30 ′ according to this embodiment (see  FIG. 4A ) is composed of substantially three sections: a head section  36 , a first (threaded) shaft section which defines a bone thread, and a second shaft section including a clearance groove  34   a . The first shaft section has an external bone thread  32  which is designed to be drilled and cut into the bone material of the adjacent end plates of the vertebral bodies  40 ,  42 . The bone thread is formed by helical grooves  39  and helical projections  38 . 
         [0044]    The second shaft section has a clearance groove  34   a  that extends from a thread runout portion of the external thread towards the head section  36 . The second shaft portion has a diameter, which in this embodiment is substantially the same as a core diameter  31  of the threaded portion  32 , i.e., a diameter as measured with regard to the helical grooves of the external thread. In other words, the diameter of the clearance groove  34   a  is smaller than that of the helical projections  38  which form the thread  32  (outer diameter). 
         [0045]    The bone screw is first inserted into the bore  2 ′ formed in front wall  4  which has the internal thread portion  22  and a cylindrical guiding portion  52 . The cylindrical guiding portion  52  is arranged to accommodate the head section  36  of the bone screw, wherein respective diameters are substantially the same in order to provide suitable guidance. Moreover, the diameter of the guiding portion  52  is larger than that of the internal thread portion  22 , wherein a transition between both portions is represented by a conical stop  50 , which may be engaged by a corresponding conical catch  35  formed on the head section  36  of the bone screw  30 ′ when a state of compression is reached (see  FIG. 4C ). 
         [0046]    The external bone thread  32  of the bone screw and the internal thread  22  of the bore are adapted to engage with each other. Hence, the bone screw may be screwed through the internal thread  22  (see  FIG. 4B ). A longitudinal length of the clearance groove  34  is substantially the same as that of the internal thread  22 . More precisely, this length of the clearance groove is substantially the same as the distance between the stop  50  and the opening  18 ′ towards the end face  20 ′ of the front wall  4  of the cage  1 . As a consequence, the thread portions  22 ,  32  disengage when the catch  35  abuts on the stop  50 . 
         [0047]    Further screwing leads to a compression of the cage  1  against the end plate of the vertebral body  40 ,  42 . However, further screwing also leads to a misorientation of the helical projection  37  at the thread runout with respect to the thread inlet  54  (i.e., the groove of the internal thread which enters the opening  18 ′) of the internal thread  22 . Thus, the helical projection  37  of the external thread  32  at the thread runout abuts on the end face  20 ′ upon further screwing (rotation of the bone screw  30 ′). 
         [0048]      FIGS. 5A-C  show in a similarly simplified construction an alternative embodiment of the present disclosure. Same numerals denote the same or like components. In this embodiment, the head section  36  of the bone screw  30 ″ is considerably shortened as compared with the previous second embodiment. The resulting deficiency in stably guiding the bone screw upon insertion is compensated by the feature of the clearance groove  34   b , which in this embodiment has an increased thickness as compared with the core diameter  31  of the thread portion  32 . 
         [0049]    However, the diameter of the clearance groove  34   b  is smaller than the outer diameter due to the helical projection of the thread portion  32 , such that the clearance groove may pass the internal thread portion of the bore  2 ″. Thereby, the clearance groove  34   b  is in close contact to corresponding projections (not shown in detail) of the internal thread portion of the bore in order to carry out the tight guiding function for the bone screw. In other words, the internal thread portion  22  simultaneously serves as the guiding portion  52   b . Numeral  52   a  (see  FIG. 5A ) merely denotes a seat for the shortened head section  36 . 
         [0050]      FIGS. 6A-C  show the corresponding construction of the bone screw mechanism with regard to the first embodiment illustrated in  FIGS. 1 to 3 . The same numerals denote the same or like components as in the other embodiments. Shown are the steps of inserting the bone screw as shown by arrow  59  in  FIG. 6A , screwing the bone screw  30   a - c  through the internal thread portion of the bores  2   a - c  as shown by arrow  60  in  FIG. 6B , and further rotating the bone screw to lock the same as detailed above with respect to  FIGS. 4A-C  as shown by arrow  61  in  FIG. 6C . Also illustrated are the resulting forces F 1 , F 2  acting on the head section  36  via catch  35  and the first shaft section of the bone screw  30   a - c  via the external thread portion (see  FIG. 6C ). 
         [0051]      FIGS. 7A ,  7 B,  8 A and  8 B illustrate the operation of locking or securing the intervertebral implant device  100  according to the first embodiment. In this specific embodiment a hexagon head bone screw is employed and a hexagon wrench key is applied to screw the bone screw  30   c  shown  FIGS. 7A and 8A .  FIG. 7A  shows a state in which the catch  35  abuts on the stop  50  and the clearance groove  34   c  extends throughout the internal thread portion  22   c  of the bore  2   c  within front wall  4 . Hence, compression starts upon further screwing. 
         [0052]    Simultaneously with further compression, further rotation  61  of the screw  30   c  by, e.g., 85 degrees misorients the helical projection  37  at the thread runout of the external thread portion  32  with respect to the thread inlet  54  (not visible in  FIGS. 7 and 8  due to the sectional view) in the opening  22   c  of bore  2   c . The orientation is shown in  FIGS. 7B and 8B . Upon loosening of the bone screw, any force acting on the bone screw  30   c  to screw it out would result in an increasing abutment of the projection  37  on the end face  20   c  of the front wall as long as the thread runout fails to meet the thread inlet  54  of the bore  2   c . Hence, a securing function is achieved with the present embodiment. 
         [0053]      FIG. 9  shows an alternative embodiment. The same reference numerals denote the same or similar parts and components as shown in the previous embodiments. One difference is that the bone screw lacks a clearance groove. However, a protection or securing mechanism against fall-out of the screw is achieved by providing a second thread portion  330  to the bone screw  300 , more specifically to the head section  36  thereof. 
         [0054]    The bore  200  formed in the front wall  400  of the cage (or a plate  400  of a plate assembly, when a bone fixation plate is considered) comprises the first internal thread portion  220  and a cylindrical guiding portion  520  adjacent to the internal thread portion. In this embodiment, the second external thread portion  330  of the bone screw  300  cooperates with the internal thread portion of the head, while the first thread portion (bone thread)  32  merely cooperates with the bone material of the adjacent bones. 
         [0055]    For this reason, the narrow opening  180  for receiving the shaft section of the bone screw is not provided with a thread. 
         [0056]    The securing mechanism is as follows: after inserting the bone screw into the bore  200  of the front wall  400  of the cage, or the plate, the second thread potion (head thread)  330  is screwed through the internal thread  220  of the bore  200 . AS the thread length L 1  of the head thread is the same as the length of the cylindrical guiding portion  520 , the external thread  330  leaves or disengages from the internal thread  220  just when the catch  35  abuts on the stop  50 . 
         [0057]    Due to the cylindrical symmetry of the guiding portion  520 , the bone screw is now freely rotatable within the bore. Hence, further compression of the catch against the stop is achieved, when the bone thread is further screwed into the adjacent bone material more deeply by for example 80 or 90 degrees to 270 or 280 degrees. The helical projection  37  at the thread runout of the head thread  330  is thereby misoriented relative to the thread inlet of the internal thread  220  within the bore  200 . Consequently, the projection  37  abuts on a corresponding end face  201  within the bore at a transition between internal thread  220  and the cylindrical guiding portion  520 . 
         [0058]    As a result, the screw cannot easily fall out of the cage or plate even if it is loosened in the bone material. Rather, the head section will securely be kept within the cylindrical guiding portion  520 . 
         [0059]    It is to be understood that the present disclosure shall not be limited by detailed features as explained herein. Rather, it is within the scope of the invention to apply various modifications to the embodiments described above. For example, the bone screw may be screwed into the bone material by mechanisms and tools than hexagon head screws, which are well known in the art. Also, as an example, the materials employed for the cage and the screw may be chosen according to the specific needs. 
         [0060]    Still further, although the embodiments employing three bores for accommodating three bone screws have been found and described as providing an optimized design with regard to stress and torsion distribution, other designs employing two, four or more bore and bone screws can be employed as well. Also, the invention is not limited to the specific arrangement of inner and outer side walls of the cage as shown in the present embodiments. In particular, the invention encompasses applications regarding bone plates or similar bone fixation devices.