Abstract:
A receiving part for receiving a rod for coupling the rod to a bone anchoring element, the receiving part including: a receiving part body having a channel for receiving a rod and defining an accommodation space for accommodating a head of a bone anchoring element, the accommodation space having an opening for inserting the head; and a pressure element at least partially in the accommodation space, the pressure element including a first portion having a recess to receive the rod, and a second portion having a flexible portion to clamp the head, wherein the pressure element is moveable along a longitudinal axis of the receiving part body from an inserting position to insert the head, to a pre-locking position to clamp the head in the receiving part by a pre-stress exerted by the pressure element, to a locking position to lock the head in the receiving part.

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
     The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/154,306, filed Feb. 20, 2009, the contents of which are hereby incorporated by reference in their entirety, and claims priority from European Patent Application EP 009 002 468.8, filed Feb. 20, 2009, the contents of which are hereby incorporated by reference in their entirety. 
    
    
     BACKGROUND 
     1. Field of the Invention 
     The invention relates to a receiving part for receiving a rod for coupling the rod to a bone anchoring element and a bone anchoring device with such a receiving part. The receiving part includes a receiving part body and a pressure element located at least partly in an accommodation space of the receiving part body. The pressure element has a flexible portion to clamp the head. The pressure element can assume in the receiving part body an insertion position in which introduction and removal of the head is permitted, a locking position in which the head is locked in the receiving part, and a pre-locking position in which the head is clamped by a pre-stress exerted by the pressure element. 
     2. Description of Related Art 
     Various designs of polyaxial bone screws, wherein the head is clamped from the side to lock the rotational position of the bone screw, are known. 
     U.S. Pat. No. 5,672,176 describes a bone screw with a receiving part with a conically shaped seat and a conically shaped pressure element which exerts a pressure onto the head from above and from the side. If the cone angle has a value laying within a specific range self-locking of the pressure element within the receiving part takes place which allows to preliminary lock the head within a receiving part while the rod is still movable in order to allow the adjustment of its position. 
     WO 2007/038350 A2 discloses an apparatus for connecting a bone anchor to a support rod, the apparatus including a connector body and a cap. The connector body has a socket for insertion, angulation and removal of a bone anchor. A sleeve is provided which is configured to fit over the connector body in a temporary position, in which the sleeve permits insertion of the bone anchor, to move to a provisional locking position, in which the sleeve permits angulation but prevents removal of the bone anchor, and to move to a locking position, in which the sleeve prevents both angulation and removal of the bone anchor. 
     U.S. Pat. No. 6,063,090 relates to a device used to connect a longitudinal support to a pedicle screw by an accommodating head having a channel to accommodate the longitudinal support. The pedicle screw and the accommodating head are connected via a conical collet chuck in the accommodating head and by a spherical head on the pedicle screw. The device allows engagement of the pedicle screw in the accommodating head after the pedicle screw has been inserted into the bone. 
     U.S. Pat. No. 6,132,432 describes a spinal implant fixation assembly including a bone fixation member such as a screw and a rod receiving seat which is operatively connected to the bone fixation element. In one embodiment a screw head receiving insert is provided, which is movable within the assembly between a locked position entrapping the screw head therein and an unlocked position, wherein the screw head enters or escapes. 
     SUMMARY 
     It is an object of the invention to provide an improved receiving part for receiving a rod for coupling the rod to a bone anchoring element and a bone anchoring device with such a receiving part. The receiving part may include fewer parts and may be more easily and/or more safely handled during surgery. 
     A pressure element can be arranged in the receiving part body in three positions. In an insertion position the head is insertable from a bottom of the receiving part body into an accommodation space of the receiving part body. In a pre-locking position, the pressure element pre-locks the head in the accommodation space, which prevents inadvertent removal of the head from the receiving part body and/or inadvertent movement of the head with respect to the receiving part body during surgery. This allows for safer handling of the bone anchoring device during surgery. In a locking position, the head is finally locked in the receiving part. The pressure element can be releasably held in the insertion position and/or in the pre-locking position. This makes handling more convenient. 
     Pre-locking and final locking of the head are achieved with the same pressure element. Hence, the receiving part and the bone anchoring device according to embodiments of the invention comprise fewer elements, which reduces the costs for manufacturing and which facilitates handling. It makes use of the principle of clamping the head of the bone anchoring element circumferentially from a lateral side, which reduces a force necessary to safely clamp the head. The design of the receiving part allows introduction of the head from the bottom of the receiving part. Such a design may be more readily utilized when a modular system is provided wherein various bone anchors and/or different receiving parts are available prior to surgery. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Further features and advantages of the invention will become apparent from the description of embodiments using the accompanying drawings. In the drawings: 
         FIG. 1  shows a perspective exploded view of a first embodiment of the bone anchoring device. 
         FIG. 2  shows a perspective view of the bone anchoring device of  FIG. 1  in an assembled state. 
         FIG. 3  shows a perspective view of a pressure element according to the first embodiment. 
         FIG. 4  shows a side view of the pressure element of  FIG. 3 . 
         FIG. 5  shows a side view of the pressure element shown in  FIG. 4  rotated by 90°. 
         FIG. 6  shows a cross-sectional view of the pressure element shown in  FIG. 5 . 
         FIG. 7  shows a bottom view of the pressure element shown in  FIGS. 3 to 6 . 
         FIG. 8  shows a cross-sectional view of a bone anchoring device according to the first embodiment with a pressure element in a first position, and when the bone anchoring element is not yet inserted, the section taken perpendicular to the rod axis. 
         FIG. 9  shows a cross-sectional view of the bone anchoring device according to the first embodiment with the pressure element in the first position and the bone anchoring element partially inserted. 
         FIG. 10  shows the bone anchoring device of  FIG. 9  with the bone anchoring element fully inserted. 
         FIG. 11  shows a cross-sectional view of the bone anchoring device of the first embodiment with the pressure element in a pre-locking position. 
         FIG. 12  shows an enlarged view of a detail of  FIG. 11 . 
         FIGS. 13   a  to  13   h  show various examples of outer and inner cooperating surfaces of the pressure element and the receiving part body, respectively. 
         FIG. 14  shows the bone anchoring device of  FIG. 8  with a rod inserted and the head locked. 
         FIG. 15  shows an exploded perspective view of a bone anchoring device according to a second embodiment. 
         FIG. 16  shows an enlarged side view of a pressure element according to the second embodiment. 
         FIG. 17  shows a cross-sectional view of the pressure element of  FIG. 16 . 
         FIG. 18  shows a side view of the pressure element of  FIG. 16  rotated by 90°. 
         FIG. 19  shows a bottom view of the pressure element of  FIG. 16 . 
         FIG. 20  shows a cross-sectional view of the bone anchoring device according to the second embodiment with the pressure element in an insertion position and the bone anchoring element not yet inserted, the cross-section taken perpendicular to the rod axis. 
         FIG. 21  shows the bone anchoring device of  FIG. 20  with the bone anchoring element fully inserted. 
         FIG. 22  shows the bone anchoring device of  FIG. 20  with the pressure element in a position just before a pre-locking position. 
         FIG. 23  shows the bone anchoring device of  FIG. 20  with the pressure element in the pre-locking position. 
         FIG. 24  shows an enlarged view of a portion of  FIG. 23 . 
         FIG. 25  shows an enlarged view of another portion of  FIG. 23 . 
         FIG. 26  shows the bone anchoring device of  FIG. 20  with the pressure element in the locking position and the head locked. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     As shown in.  FIGS. 1 and 2 , a bone anchoring device according to a first embodiment comprises a bone anchoring element  1  in the form of a bone screw having a threaded shaft  2  and a head  3 , which is in this embodiment a spherical segment-shaped head. The head  3  has a recess  4  for engagement with a screwing-in tool. The bone anchoring device further comprises a receiving part body  5  for receiving a rod  6  to connect the rod  6  to the bone anchoring element  1 . Further, a closure element  7  in the form of an inner screw is provided for securing the rod  6  in the receiving part body  5 . In addition, the bone anchoring device includes a pressure element  8  for locking the head  3  in the receiving part body  5 . The pressure element  8  is held in the receiving part body  5 , for example via pins  9   a ,  9   b.    
     The receiving part body  5  is now explained with reference to  FIGS. 1 and 8  to  14 . The receiving part body  5  comprises a first end  10  and a second end  11  opposite the first end and an axis of symmetry M passing through the first end and the second end. A bore  12  is provided which is coaxial with the axis of symmetry M. In a first region adjacent to the first end  10 , the receiving part body  5  has a U-shaped recess  13 , which is symmetric with respect to the axis of symmetry M, the recess  13  having a bottom directed towards the second end  11  and two free lateral legs  14   a ,  14   b  extending towards the first end  10 . In the region of the legs  14   a ,  14   b  an internal thread  15 , which cooperates with the inner screw  7 , is provided. A channel formed by the U-shaped recess  13  is sized so as to receive the rod  6  therein, the rod to connect a plurality of anchoring devices. At a second region near the second end  11 , a cylindrical portion of the bore  12  is followed by a first tapered portion  16  tapering towards the second end  11  with a cone angle. The first tapered portion  16  is followed by a second tapered portion  17  tapering towards the second end  11  with a cone angle smaller than the cone angle of the first tapered portion. An opening  18  is provided at the second end  11 . A diameter of the opening  18  is larger than a diameter of the head  3  and smaller than the inner diameter of the bore  12 . The coaxial bore  12  provides an accommodation space  19  for the screw head  3 . 
     On each leg  14   a ,  14   b , bores  20   a ,  20   b  extending through the legs  14   a ,  14   b  are provided for receiving the pins  9   a ,  9   b . The bores  20   a ,  20   b  are located approximately at a center of each leg. 
     As can be seen in  FIGS. 1 and 3  to  7 , the pressure element  8  includes a first portion  81 , which is substantially cylindrical and which has an outer diameter which is slightly smaller than the inner diameter of the bore  12 , so that the pressure element  8  is movable in the bore  12 , and a second portion  82  which is recessed with respect to the first portion and which has a maximum outer diameter which is smaller than the inner diameter of the bore  12 . The first portion  81  has at its end opposite to the second portion  82  a U-shaped recess  83  for receiving the rod  6  therein when the pressure element  8  is situated in the receiving part body  5 . At the lateral sides of the U-shaped recess the pressure element comprises two elongate recesses  84  in the outer wall which are arranged opposite to each other, and which are aligned such that a longer side of the elongate recesses  84  is parallel to the axis of symmetry M of the receiving part body  5 . As can be seen in  FIG. 4 , the width of the lateral sides of the first portion  81  decrease towards the end opposite to the second portion  82  for at least a part of the first portion  81 . 
     The second portion  82  is formed similar to a collar, and comprises a first end at the side of the first portion  81  which is recessed with respect to the first portion  81  and a second end, and a hollow interior  85  which is substantially spherically shaped to clamp the spherical head  3  therein. The second end of the second portion  82  has an opening  86  for introduction of the head  3 . An outer wall of the second portion  82  comprises a first portion  87  which is spherical and a second portion  88  adjacent to the opening  86  which is tapered. The tapered portion  88  of the pressure element cooperates with the second tapered portion  17  of the receiving part body. The second portion  82  of the pressure element further comprises a plurality of slits  89  extending from an edge of the opening  86  through the second portion  82 . The number and dimensions of the slits  89  are such that the wall of the second portion is flexible enough to snap onto the head  3  when the head  3  is being inserted. Further, the pressure element comprises a coaxial bore  90  for providing access to the screw head  3  by a tool. 
     As can be seen in  FIGS. 8 to 14 , since the pressure element has a maximum outer diameter which is slightly smaller than the inner diameter of the bore  12 , it can be inserted from the first end  10  of the receiving part body  5  into the receiving part body  5 . Once the pressure element  8  is inserted, the pins  9   a ,  9   b  are introduced in the bores  20   a ,  20   b  so that they engage in the elongate recesses  84 , thereby holding the pressure element  8  in the receiving part body  5  and with the U-shaped recess  83  aligned with the U-shaped recess  13  of the receiving part body  5 , and preventing escaping of the pressure element through the first end  10 . Since the second portion  82  of the pressure element  8  has an outer diameter which is smaller than the inner diameter of the bore  12 , and since the second portion  82  of the pressure element has a flexible outer wall, the second portion can expand within the accommodation space  19  when the screw head  3  is introduced. 
     All parts described before may be made of a bio-compatible material, such as a bio-compatible metal like stainless steel or titanium, or a bio-compatible metal alloy, for example, nitinol, or are made from a bio-compatible plastic material, for example, PolyEtherEtherKetone (PEEK). 
     The steps of assembling the bone anchoring device are now explained with respect to  FIGS. 8 to 14 . First, when the pressure element  8  is introduced into the receiving part body  5  and held by the pins  9   a ,  9   b , it is oriented such that the opening  86  is directed towards the second end  11  of the receiving part body  5 . As shown in  FIG. 8 , the pressure element  8  is in its uppermost position which is an insertion position for allowing the screw head  3  to be inserted. In the insertion position, the flexible second portion of the pressure element is positioned freely in the accommodation space  19 . The insertion position is limited against upward movement by an abutment which is in this embodiment provided by the engagement of the pins  9   a ,  9   b  with the lower end of the recesses  84 . As shown in  FIG. 9 , the screw head  3  is then inserted through the opening  18  into the accommodation space  19 , where the second portion  82  of the pressure element  8  is located. The screw head  3  is introduced into the hollow interior  85  of the second portion  82  of the pressure element through the opening  86 . Due to the flexibility of the wall provided by the slits  89 , the second portion  82  expands in the accommodation space  19  as shown in  FIG. 9 . The second portion  82  snaps onto the screw head  3  until it encompasses the screw head  3  as shown in  FIG. 10 . The pins also prevent the pressure element  8  from escaping through the open first end  10  when the screw head  3  is inserted. In the insertion position the screw head  3  is pivotable in the receiving part and also removable if the pressure element remains in this position. There may be means (not shown) for holding the pressure element temporarily in the insertion position. Alternatively, the pressure element can be held in the insertion position by means of a tool (not shown). 
       FIGS. 11 and 12  show a pre-locking position of the pressure element. When the screw head  3  is inserted and the pressure element  8  is pressed down slightly, the outer wall of the second portion  82  of the pressure element is guided by the first tapered portion  16 , so that it contacts the second tapered portion  17  of the receiving part body. The tapered portion  88  of the outer wall of the pressure element  8  and the tapered portion  17  of the receiving part body  5  come into engagement, whereby a prestress is exerted by the second portion  82  of the pressure element onto the screw head  3 , which pre-locks the head  3 . Pre-locking means that under conditions arising during surgery, an angular position of the bone anchoring element  1  with respect to the receiving part body  5  is maintained and can be loosened only by exerting an additional force onto the receiving part body or the bone anchoring element. The pre-locking position of the pressure element can be achieved either manually by pushing down the pressure element, or by inserting the rod and screwing in the inner screw  7  so that the rod presses onto the pressure element thereby moving it slightly downwards. 
       FIGS. 13   a  and  13   b  show the engagement of the outer surface portion of the pressure element and the inner surface portion of the receiving part body in the pre-locking condition. As described before, the surfaces  17 ,  88  can be tapered as shown in  FIG. 13   a . Alternatively to, or in addition to, tapered surfaces, portions of the surfaces  88 ′,  17 ′ can be rounded as shown in  FIG. 13   b . The first tapered portion  16  at the receiving part body  5  serves only for guidance in some embodiments and can be omitted. 
       FIGS. 13   c  to  13   h  schematically show various examples of engagements of the outer surface portion of the pressure element and the inner surface portion of the receiving part body. In  FIG. 13   c  the two tapered portions  17 ,  88  are tapered at substantially a same angle. This provides a substantially even pressure distribution (approximated by arrows) between the second portion  88  of the pressure element and the tapered portion  17  of the receiving part body.  FIGS. 13   d  and  13   e  show two different variations where the portions are tapered at different angles.  FIG. 13   d  shows a main contact area at the bottom of portion  17 ″ and  FIG. 13   e  shows a main contact area at the top of portion  17 ′″.  FIG. 13   f  shows a tapered portion  88 ″″ of the pressure element and a rounded or curved portion  17 ″″ of the receiving part body, wherein the curvature is directed towards the center of the receiving part body. With such a configuration, a focused contact area at the rounded portion can be achieved. 
     In  FIGS. 13   g  and  13   h  the narrowing portion  170  of a modified example of the receiving part body  5  has a double spherical radius formed by two curved portions  170   a  and  170   b  adjacent to each other with a groove  170   c  therebetween. The curvatures are directed to a central axis M. A modified pressure element  180  has at its lower end two correspondingly curved portions  180   a  and  180   b  which correspond to the curved portions  170   a  and  170   b , with a crest  180   c  therebetween, and an outer crest  180   d  at an outer edge of the pressure element  180 . 
     As shown in  FIG. 13   g , when the pressure element  180  moves downwards, its lowermost edge  180   d  engages in the groove  170   c . In this position, there is a frictional clamping of the head  3 , which still allows the head  3  to be pivoted upon exertion of a force which is greater than the force needed to pivot the head  3  when the head  3  is introduced in the insertion position. This is an example of the pre-locking condition. As shown in  FIG. 13   h , by pressing the pressure element  180  further downward, the respective curvatures  180   a ,  180   b  of the pressure element  180  engage with the corresponding curvatures  170   a ,  170   b  of the narrowing portion  170  to lock the head  3 . 
     The third position of, for example, the embodiment of  FIG. 8 , which is a locking position, is shown in  FIG. 14 . The locking position is defined as the position in which the screw head  3  is locked in the receiving part body  5 . In this position, the tapered outer surface portion  88  of the pressure element engages the second tapered portion  17  of the receiving part body over a larger area. Thereby, the flexible wall of the second portion  82  of the pressure element  8  is pressed onto the head  3  so that the head  3  is locked. This position is achieved by further tightening the inner screw  7 , thereby further pressing down the rod  6 . 
     In use, the bone anchoring device can be, for example, pre-assembled in such a way that a suitable bone anchoring element  1  is selected and introduced into the receiving part body  5  with an inserted pressure element  8 . The bone anchoring device can be brought into the pre-locking condition by slightly pushing down the pressure element  8 . Then, the screw element  1  is screwed into the bone. The recess  4  of the head  3  can be accessed with a screw tool through the coaxial bore  12  and the bore  90 . To correctly align the receiving part with respect to the rod to which it shall be connected, an additional force is exerted onto the receiving part either manually or by application of an instrument. Once a desired position of the rod with respect to other bone anchoring devices is achieved, the inner screw  7  is tightened, thereby shifting down the pressure element into the locking position. A final tightening of the inner screw locks the rod and the head substantially simultaneously. 
     The bone anchoring device can be pre-assembled either by the manufacturer or in the course or preparation of surgery, or at any other time. In one embodiment, the surgeon can select the desired receiving parts and bone anchoring elements prior to surgery according to specific details of the particular clinical application. The design of the bone anchoring device allows selection of an appropriate bone anchoring element in terms of diameter, length, and other features. Hence, a modular system is provided which includes various receiving parts and several bone anchoring elements, which then individually can be chosen and adapted. 
     A second embodiment of the bone anchoring device is now described with respect to  FIGS. 15 to 26 . Parts which are similar to those of the first embodiment have the same reference numerals, and the descriptions thereof will not be repeated. The second embodiment of the bone anchoring device differs from the first embodiment in the design of the pressure element and the pins. The first portion  81 ′ of the pressure element  8 ′ differs from the first portion  81  of pressure element  8 . The first portion  81 ′ of the pressure element  8 ′ has a shallow recess  83 ′ which is curved in a substantially cylinder segment shape for guiding the rod  6 . It further includes two upstanding resilient fingers  91   a ,  91   b  extending from respective lateral sides of the recess  83 ′ in the direction of the first end  10  of the receiving part body. The fingers  91   a ,  91   b  have outwardly directed portions  92  at their free ends, respectively. An outer diameter of the first portion  81 ′ at least in the region of the fingers, is smaller than the inner diameter of the bore of the receiving part body, such that the resilient fingers  91   a ,  91   b  can move. 
     Pins  9   a ′,  9   b ′ each have a flattened portion  93 , a width of which is substantially the same as a width of the outwardly extending portions  92  of the resilient fingers  91   a ,  91   b . When the pins  9   a ′,  9   b ′ are inserted into the bores  20   a ,  20   b , the portions  93  extend into the coaxial bore  12  of the receiving part body  5  as shown in  FIG. 20 . In this manner, an abutment is provided for the receiving part  8 ′. 
     The assembly of the bone anchoring device according to the second embodiment is explained with respect to  FIGS. 20 to 25 . In  FIG. 20 , first, the pressure element  8 ′ is inserted from the first end  10  into the receiving part body  5 . Then the pins  9   a ′,  9   b ′ are inserted into the holes in the legs. The pressure element  8 ′ is in such a position that the outwardly extending portions  92  of the resilient fingers  91   a ,  91   b  are located above the flattened portions  93  of the pins  9   a ′,  9   b ′. In this position the pressure element  8 ′ is in an insertion position. Then, the screw head is inserted through the openings  18  and  86  until the second portion  82  of the pressure element  8 ′ is around the screw head  3 . Then, as shown in  FIG. 22 , the pressure element  8 ′ is moved slightly downward to enter a pre-locking position. Here, the resilient fingers  91   a ,  91   b  are first pressed inwards for the outwardly extending portion  92  to move past the flattened portion  93  of the pins. As shown in  FIG. 23 , the outwardly extending portions  92  then move outward and the flattened portions  93  form an abutment for the pressure element. In this pre-locking position, the tapered outer surface portion of the second portion  82  engages the tapered portion  17  of the receiving part body. Since the pins  9   a ′,  9   b ′ act as a stop, the pre-locking position is secured (i.e., the pressure element  8 ′ does not move back to the insertion position). 
     Inserting the rod and screwing in the inner screw  7  moves the pressure element further down until it achieves a final locking position as shown in  FIG. 26 . 
     The clinical use of the bone anchoring device is similar to that of the first embodiment. 
     Further modifications of the embodiments shown are possible. For example, the head of the bone anchoring element can have any other shape, for example, a cylindrical shape whereby a monoaxial bone screw is provided allowing rotation of the screw element with respect to the receiving part around a single axis. The head  3  can also be, for example, conically shaped, where the hollow interior portion  85  of the pressure element is adapted to this shape. In a further modification, the receiving part body  5 , or at least the second portion  82  of the pressure element, is made of a bio-compatible plastic material which provides elasticity to a certain degree. In this case, the slits may be omitted. 
     Alternatively to the second embodiment a spring portion can be provided, for example in the receiving part body, which may cooperates with a portion of the pressure element. Generally, the pins are only one example of achieving an abutment for the pressure element. Other constructions such as snap rings or various other features may also be utilized. 
     In one embodiment, the receiving part body can have an inclined open end to allow a greater angulation of the head in one direction. 
     In one embodiment, the outer surface of the second portion  82  of the pressure element can be tapered, and the second tapered portion  17  of the receiving part body can be inwardly curved. 
     While the present invention has been described in connection with certain exemplary embodiments, it is to be understood that the invention is not limited to the disclosed embodiments, but is instead intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims, and equivalents thereof.