Abstract:
A bone anchoring device includes an anchoring element including a shaft and a head; a receiving part including a first end and a second end, and having a channel for receiving a rod near the first end, and an accommodation space for accommodating the head near the second end; and a pressure element configured to be located at least partially in the accommodation space and including a flexible portion to clamp the head, wherein the anchoring element is pivotable, and the pressure element is movable inside the accommodation space to lock the head within the pressure element, and wherein a first securing portion on the pressure element and a second securing portion on the receiving part are configured to engage and form a rigid coupling therebetween to prevent removal of the pressure element from the first end of the receiving part.

Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
       [0001]    The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/288,608, filed Dec. 21, 2009, the contents of which are hereby incorporated by reference in their entirety, and claims priority to European Patent Application EP 09 180 249.6, filed Dec. 21, 2009, the contents of which are hereby incorporated by reference in their entirety. 
     
    
     BACKGROUND 
       [0002]    1. Field 
         [0003]    The invention relates to a bone anchoring device for anchoring a stabilization rod in a bone or in a vertebra. The bone anchoring device includes an anchoring element, a receiving part for receiving a head of the bone anchoring element and for receiving the stabilization rod to be connected to the anchoring element. The anchoring element is pivotably connected to the receiving part and can be fixed at an angle by exerting pressure onto the head via a pressure element which is arranged in the receiving part. The pressure element has a flexible portion to clamp the head. The pressure element also has a securing portion which engages a securing portion at the receiving part to prevent a loss of the pressure element after insertion of the pressure element into the receiving part. 
         [0004]    2. Description of Related Art 
         [0005]    U.S. Pat. No. 5,716,356 describes a polyaxial bone screw including a screw element and a receiving part which is pivotably connected to the screw element and a pressure element to exert pressure onto the head of the screw element to fix the angle between the screw element and the receiving part. The pressure element is held in the receiving part in an aligned position by means of crimping through bores provided in the receiving part. 
         [0006]    U.S. Pat. No. 5,672,176 describes another example of a polyaxial bone screw with a pressure element which is also held in place by crimp bores without impeding a sufficient movement of the pressure element to clamp the head. 
         [0007]    WO2006/116437 A2 describes a bone anchor for spinal fixation in the form of a polyaxial bone screw including a screw element, a housing, a sleeve and a collet arranged in the housing for exerting pressure onto the head of the screw element. The sleeve has retention tabs which snap into slots in opposite wall positions of the housing. 
         [0008]    The polyaxial bone screw described in DE 43 07 576 C1 has an inner thread at the receiving part which engages an outer thread of the pressure element as well as an outer thread of a clamping screw which clamps the head. WO98/34554 describes a multi-axial bone engaging fastener assembly wherein a crown member presses onto the head of the bone screw. The crown member is threaded and inserted by threading it through the threaded portion of the receiver member. Therefore, it cannot escape inadvertently. 
         [0009]    Usually, the polyaxial bone anchoring devices of the above described types are provided, for example, by the manufacturer, in a pre-assembled condition. In this condition a specific screw element, for example, a screw element having a specific length and a specific shaft diameter or specific thread form is connected to the receiving part, and the pressure element is arranged therein so that it cannot fall out. For surgery, the necessary number and types of such pre-assembled polyaxial bone screws are selected and provided in advance as a full set of implants. 
       SUMMARY 
       [0010]    Embodiments of the invention provide a bone anchoring device, wherein parts can be selected and assembled by the surgeon or by any other personnel in a simple manner at the operation site, or at any other place after the parts have been manufactured. In addition, the bone anchoring device provides for improved handling during surgery. 
         [0011]    The bone anchoring device has few parts. The parts are of a simple design. This provides for lower costs of manufacturing and convenient handling. The bone anchoring device can be assembled at any point after the parts have been manufactured and before the screw element is inserted into the bone. Therefore, assembling of the polyaxial bone screw can be carried out by anybody, in particular by the surgeon or by any personnel assisting him before or during surgery. 
         [0012]    With such a bone anchoring device, a modular system can be provided which allows for combinations of various anchoring elements with any suitable receiver on demand, depending on actual clinical requirements and situations. This reduces the costs of polyaxial screws, reduces inventory, and gives the surgeon a substantial choice of implants. In addition, existing receiving parts may be upgraded to form the bone anchoring device according to embodiments of the invention. 
         [0013]    The pressure element of the bone anchoring device is secured against falling out (i.e., loss of the pressure element). The coupling between the receiving part and the pressure element is implemented by a rigid coupling, which is easier to manufacture than a spring based coupling. The screw element can be assembled from the top of the receiving part or from the bottom of the receiving part. This gives the surgeon using the bone anchoring device substantial freedom with respect to application of the bone anchoring device. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    Further features and advantages of the invention will become apparent from the description of embodiments by means of the accompanying drawings. In the drawings: 
           [0015]      FIG. 1  shows an exploded perspective view of a bone anchoring device according to a first embodiment; 
           [0016]      FIG. 2  shows the bone anchoring device of  FIG. 1  in an assembled state; 
           [0017]      FIG. 3  shows a cross-sectional view of the bone anchoring device according to the first embodiment, the cross-section taken perpendicular to a rod axis; 
           [0018]      FIG. 4  shows a cross-sectional view of the bone anchoring device according to the first embodiment, the cross-section taken along the rod axis; 
           [0019]      FIG. 5  shows a perspective view of a pressure element of the bone anchoring device according to the first embodiment; 
           [0020]      FIG. 6  shows a cross-sectional view of the pressure element, the cross-section taken perpendicular to the rod axis; 
           [0021]      FIG. 7  shows a side view of the pressure element of  FIG. 5  seen in a direction perpendicular to the rod axis; 
           [0022]      FIG. 8  shows a bottom view of the pressure element of  FIG. 5 ; 
           [0023]      FIGS. 9   a  to  9   d  show steps of assembling the bone anchoring device according to the first embodiment in a first sequence; 
           [0024]      FIGS. 10   a  to  10   d  show steps of assembling the bone anchoring device according to the first embodiment in a second sequence; 
           [0025]      FIG. 11  shows an exploded perspective view of a bone anchoring device according to a second embodiment; 
           [0026]      FIG. 12  shows a cross-sectional view of the bone anchoring device according to the second embodiment in an assembled state, the cross-section taken perpendicular to a rod axis; 
           [0027]      FIG. 13  shows an enlarged cross-sectional view of the second embodiment as shown in  FIG. 12  without the rod and the fixation screw; 
           [0028]      FIG. 14  shows a top view of the bone anchoring device according to the second embodiment; 
           [0029]      FIG. 15  shows a perspective view of a pressure element of the bone anchoring device according to the second embodiment; 
           [0030]      FIG. 16  shows a cross-sectional view of the pressure element of  FIG. 15 , the cross-section taken perpendicular to the rod axis; 
           [0031]      FIG. 17  shows a bottom view of the pressure element of  FIG. 15 ; 
           [0032]      FIG. 18  shows a perspective view from the top of a receiving part of the bone anchoring device according to a modification of the second embodiment; 
           [0033]      FIG. 19  shows a side view perpendicular to the rod axis of the receiving part of  FIG. 18 ; 
           [0034]      FIG. 20  shows a cross-sectional view of the receiving part of  FIG. 18 , the cross-section taken along line A-A of  FIG. 19 ; 
           [0035]      FIG. 21  shows a cross-sectional view from the top of the receiving part of  FIGS. 18 and 19 , the cross-section taken along plane C in  FIG. 19 ; 
           [0036]      FIG. 22  shows a cross-sectional view of the pressure element of the modified second embodiment; 
           [0037]      FIG. 23  shows a cross-sectional view of the receiving part and the inserted pressure element, the cross-section taken along plane C in  FIG. 19 ; 
           [0038]      FIG. 24  shows an exploded perspective view of the bone anchoring device according to a third embodiment; 
           [0039]      FIG. 25  shows a cross-sectional view of the bone anchoring device according to the third embodiment in an assembled state, the cross-section taken perpendicular to a rod axis; and 
           [0040]      FIG. 26  shows a side view of a pressure element according to the third embodiment. 
       
    
    
     DETAILED DESCRIPTION 
       [0041]    As shown in  FIGS. 1 and 2 , a bone anchoring device according to a first embodiment includes a bone anchoring element  1  in the form of a bone screw having a threaded shaft  2  and a head  3 , which in this embodiment is a spherical segment-shaped head. The head  3  has a recess  4  for engagement with a screwing-in tool. The bone anchoring device further includes a receiving part  5  for receiving a rod  6  to connect the rod to the bone anchoring element  1 . Further, a fixation element  7  in the form of an inner screw or set screw is provided for securing and clamping the rod  6  in the receiving part  5 . In addition, the bone anchoring device includes a pressure element  8  for exerting pressure to lock the head  3  in the receiving part  5 . 
         [0042]    The receiving part  5  is explained with reference to  FIGS. 1 to 4 . The receiving part  5  includes a first end which may be characterized as a top end  5   a  and a second end which may be characterized as a bottom end  5   b , and an axis of symmetry M passes through the top end  5   a  and the bottom end  5   b . A bore  9  which is coaxial with the axis of symmetry M extends from the top end  5   a  to the bottom end  5   b . By means of the bore  9 , an opening  10  is provided at the bottom end. The diameter of the bore  9 , and therefore the diameter of the opening  10  at the bottom end  5   b , is greater than a greatest outer diameter of the head  3 . Adjacent the bottom end  5   b , the bore  9  has a narrowing section  9   a , which narrows towards the bottom end  5   b . The narrowing section can have a taper or a rounded portion or any other shape which provides exertion of a compression force onto a pressure element  8  which is described below. The narrowing section  9   a  also provides a seat for the screw head  3  with the pressure element  8 . The bore  9  further includes in the lower portion of the receiving part  5  a section  9   b  with an enlarged diameter, and following or adjacent to this a middle section  9   c  with a reduced diameter which is still greater than the largest diameter of the head  3 . Following or adjacent to the reduced diameter middle section  9   c , a recessed section  9   d  with an enlarged diameter is formed, which serves as a securing portion for engagement with the pressure element  8 . Between the recessed section  9   d  and the top end  5   a  there is a section  9   e  which is provided with an internal thread. The diameter of the section  9   e  is smaller than the diameter of the section  9   d  and slightly smaller than the largest outer diameter of the pressure element  8 , but still greater than the outer diameter of the head  3 . 
         [0043]    In a region adjacent to the top end  5   a  the receiving part  5  has a substantially U-shaped recess  11 , which is symmetric with respect to the symmetry axis M. The recess  11  has a bottom which is directed towards the bottom end  5   b , and provides for two free lateral legs  11   a ,  11   b  extending towards the top end  5   a . The channel formed by the substantially U-shaped recess  11  is sized so as to receive a rod  6  therein, which can connect a plurality of anchoring devices. 
         [0044]    As can be seen in particular in  FIGS. 3 and 4 , the recessed section  9   d  is located on the inner wall of the legs  11   a ,  11   b . The recessed section  9   d  cooperates with a portion of the pressure element  8 , to prevent escaping of the pressure element  8  from the receiving part  5 . 
         [0045]    As can be seen in  FIGS. 1 and 3  to  8 , the pressure element has a top end  8   a  and a bottom end  8   b . Adjacent to the top end  8   a  there is a substantially cylindrical first section  81  which has an outer diameter which is slightly smaller than the inner diameter of the middle section  9   c  of the bore  9 , so that the pressure element  8  can extend, with at least a part of its cylindrical section  81 , through the middle section  9   c  of the receiving part  5 . Adjacent to the top end  8   a , a substantially U-shaped recess  82 , is provided which is formed to guide the rod  6  therein. By means of the substantially U-shaped recess  82 , a channel with side walls  82   a ,  82   b  is formed. At a distance from the top end  8   a  on each side wall  82   a ,  82   b , a projection  83  is formed which extends from the outer wall in a circumferential direction along the side walls  82   a ,  82   b . The outer diameter of the projection  83  is greater than the inner diameter of the middle section  9   c  of the bore  9  and greater than the inner diameter of the threaded section  9   e  of the receiving part  5 , but slightly smaller than the inner diameter of the recessed section  9   d , so that the projection  83  can engage the recessed section  9   d . Hence, the projection  83  forms a securing portion which cooperates with the recessed section  9   d  to prevent loss of the pressure element  8  from the receiving part  5 . The width of the side walls  82   a ,  82   b  of the channel as can be seen in  FIG. 7 , is at least slightly smaller than the width of the substantially U-shaped recess  11  of the receiving part  5 . The pressure element  8  has a further recess  84  in the outer wall of each side wall  82   a ,  82   b  which is located on the side of the projection facing away (e.g., farther away) from the top end  8   a  and which can serve, for example for engagement with a tool (not shown). 
         [0046]    The pressure element  8  further has a second section  85  which has a hollow interior  86  which is substantially spherically-shaped and is sized to clamp the spherical head  3  therein. A greatest outer diameter of the second section  85  is substantially the same as the outer diameter of the cylindrical first section  81 . A free end of the second section  85  provides an opening  87  for the introduction of the head  3 . Further, the second section  85  includes a plurality of slits  88  extending from the opening  87  through the second section  85  to define or form a resilient wall. The number and the dimension of the slits  88  is such that the wall of the second portion  85  is flexible enough to snap onto the head  3  when the head  3  is being inserted. The slits  88  may extend into the first cylindrical section  81  (not shown) to enhance flexibility. The outer surface of the second section  85  is substantially rounded and has tapered or curved or otherwise narrowing portion  89  towards the bottom end  8   b . The narrowing portion  89  cooperates with the narrowing portion  9   a  of the receiving part  5  when the head is being locked in the receiving part  5 . 
         [0047]    The fixation element  7  is in this embodiment an inner screw which is configured to press onto the rod  6  when it is screwed-in between the legs  11   a ,  11   b  of the receiving part  5 . It should be noted that in the embodiment shown the side walls  82   a ,  82   b  extend below the rod surface when the rod  6  is inserted. Hence, by tightening the inner screw  7 , pressure is also exerted onto the pressure element  8 , and therefore onto the head  3 . However, any other closure and fixation mechanism is conceivable. For example, the fixation element  7  can be a two-part fixation element having an outer screw pressing onto the top end of the pressure element and an inner screw which independently presses onto the rod for independent rod and head fixation. 
         [0048]    The section  9   e  of the receiving part having the internal thread is shown with a flat thread in the figures. However, any other thread form may instead be implemented. Specific closure and fixation mechanisms adapted to a specific thread form may then be utilized. 
         [0049]    The parts of the bone anchoring device are made of a body compatible material, in particular of a body compatible metal, metal alloy or body compatible plastics. For example, materials like stainless steel, titanium, nickel titanium alloys, such as Nitinol, body compatible plastics such as polyether ether ketone (PEEK) or combinations thereof may be used. 
         [0050]    The steps of assembling the bone anchoring device according to a first sequence are now described with reference to  FIGS. 9   a  to  9   d . In a first step shown in  FIG. 9   a  a specific bone anchoring element  1  which is suitable for the intended clinical application is provided. It can be selected from a plurality of bone anchoring elements having different shaft lengths, shaft diameters etc. Usually the heads  3  of the bone anchoring elements have approximately the same size. The receiving part  5  and the pressure element  8  are provided. Then the pressure element  8  is first assembled with the screw element  1 . That means, the head  3  is inserted through the opening  87  into the hollow interior section  86  of the pressure element  8 . By means of the flexible wall sections, the pressure element  8  is easily snapped onto the head  3 . 
         [0051]    Then, as shown in  FIG. 9   b  the bone anchoring element  1  with the pressure element  8  mounted thereon is inserted from the top end  5   a  into the receiving part  5 . The orientation of the pressure element  8  relative to the receiving part  5  is such that the projections  83  point in the direction of (e.g., aligned with) the U-shaped recess. As shown in  FIG. 9   c  the bone anchoring element  1  with the pressure element  8  mounted thereon is then further inserted into the receiving part  5  with the projection  83  of the pressure element  8  being located within the U-shaped recess  11 . 
         [0052]    Then, as shown in  FIG. 9   d  in connection with  FIGS. 3 and 4  the bone anchoring element  1  together with the pressure element  8  is rotated by 90° such that the projection  83  on either side of the side walls of the pressure element  8  engages the recessed section  9   d  on either side of the legs  11   a  and  11   b  of the receiving part  5 . When the projection  83  engages the recessed section  9   d , the pressure element  8  is prevented from falling out, since the projection  83  is hindered by the upper edge of the recessed section  9   d  acting as a stop. Further, the pressure element  8  is prevented from being inserted too deeply, since the lower edge of the recessed section  9   d  adjacent to middle section  9   c  also acts as a stop. In this position, which is shown in  FIGS. 3 and 4  the flexible second section  85  of the pressure element  8  is compressed by the narrowing portion  9   a  of the receiving part  5  to clamp the head  3 . 
         [0053]    Further, as can be seen in  FIG. 9   d , the substantially U-shaped recesses of the pressure element  8  and the receiving part  5  are aligned by rotation of the pressure element  8 . 
         [0054]    According to the first sequence of steps of assembly described above, the bone anchoring device is used as a top loading polyaxial bone anchoring device (i.e. the bone anchoring element  1  is introduced from the top end  5   a  of the receiving part  5 ). 
         [0055]    In clinical use, the surgeon or any other personnel, for example assistant personnel, can select a suitable bone anchoring element and assemble the polyaxial bone anchoring device by himself using, for example, simple tools. After assembly, the bone anchoring element is inserted into a bone and the receiving part  5  is aligned with a stabilization rod  6  which connects several bone anchoring devices. To fix the rod  6  to the bone anchoring element, a fixation element  7  is tightened. By tightening the fixation element, the narrowing portion  89  of the pressure element  8  is further pressed into the narrowing section  9   a  of the receiving part  5  so that after final tightening the head  3  is clamped firmly, so that it is locked in a particular angular position with respect to the receiving part  5 . Due to the design of the pressure element  8  and the receiving part  5 , depending on the specific geometry of the narrowing portion  85  of the pressure element  8  and the narrowing section  9   a  of the receiving part  5 , a self-locking of the head  3  may occur before final locking. A self-locking can occur, for example, if the sections  9   a  and  89  have a taper with an appropriate cone angle for friction-locking. The self-locking may be of use in some clinical application where it is desirable to maintain an angular relation between the screw element and the receiving part before final locking. 
         [0056]    The assembly of the bone anchoring device according to a second alternative sequence of steps is now described with reference to  FIGS. 10   a  to  10   d . As shown in  FIGS. 10   a  and  101 ) first, the pressure element  8  is inserted from the top end  5   a  into the receiving part  5 . The projection  83  points into the U-shaped recess  11  of the receiving part  5 . Then, as shown in  FIG. 10   c  the pressure element  8  is rotated by 90° such that the projection  83  engages the recessed portion  9   d . In this position, the pressure element  8  is prevented from escaping through the top end  5   a . Further, the U-shaped recesses of the pressure element  8  and the receiving part  5  are aligned. Then, the bone anchoring element  1  is inserted through the opening  10  at the bottom end  5   b  of the receiving part  5 , and inserted into the flexible second portion  85  of the pressure element  8 , as shown in  FIG. 10   d . Thereby, the pressure element  8  is moved towards the top end  5   a  of the receiving part  5  until the projection  83  abuts against an upper edge of the recess  9   d , which acts as a stop. The flexible section of the pressure element  8  can widen into the space provided by the section  9   b  of the bore  9  to snap onto the head  3 . 
         [0057]    In the manner described above the bone anchoring device can be used as a bottom loading polyaxial bone anchoring device, wherein the bone anchoring element  1  is introduced into the receiving part  5  from the bottom end  5   b . In clinical use, the bone anchoring element  1  may first be inserted into the bone, and the receiving part  5  with pressure element  8  therein may then be mounted on the bone anchoring element  1 . 
         [0058]    A second embodiment of the bone anchoring device is described with reference to  FIGS. 11 to 17 . Parts which are similar to the first embodiment are indicated with the same reference numerals and the descriptions thereof are not repeated. The second embodiment differs from the first embodiment in the design of the pressure element and the receiving part. The pressure element  8 ′ has instead of the channel provided by the U-shaped recess  82  only a groove  82 ′ in which the rod  6  rests. At the lower end of the cylindrical portion  81  which faces away from (e.g., opposite to) the top end  8   a , two projections  83 ′ which are offset at 90° from the groove  82 ′ are provided. As shown in  FIG. 12 , when the bone anchoring device is assembled and the fixation element  7  is tightened, the projections  83 ′ extend into the enlarged diameter section  9   b  in the lower portion of the receiving part  5 ′. An upper edge of this portion  9   b  forms a stop for the projection  83 ′ which prevents escaping of the pressure element  8 ′ through the top end  5   a  when the rod  6  and the fixation element  7  are not inserted, as shown in  FIG. 13 . 
         [0059]    To allow the insertion of the pressure element  8 ′ into the receiving part  5 ′ and engagement of the projections  83 ′, the receiving part  5 ′ has on the bottom of its substantially U-shaped recess  11  two recesses  11   c , which are positioned and sized such that the projections  83 ′ can engage therewith (e.g., pass through) during insertion of the pressure element  8 ′. 
         [0060]    The assembly of the bone anchoring device is similar to that of the first embodiment. The pressure element  8 ′ alone or the pressure element  8 ′ with the bone anchoring element  1  mounted therein is inserted into the receiving part  5 ′ with the projections  83 ′ pointing into the U-shaped recess  11  of the receiving part  5 ′. The pressure element  8 ′ is moved in the direction towards the bottom end  5   b  of the receiving part  5 ′ until the projections  83 ′ engage the recesses  11   c  on the bottom of the substantially U-shaped recess  11 . After further insertion, when the projections  83 ′ reach the section  9   b  with the enlarged diameter, the pressure element  8 ′ is rotated by 90° so that its groove  82 ′ is aligned with the U-shaped recess  11  of the receiving part  5 ′. In this condition, the pressure element  8 ′ is secured against falling out. 
         [0061]    A modification of the second embodiment is now described with reference to  FIGS. 18 to 23 . It differs from the second embodiment in that the pressure element  8 ″ has only one projection  83 ″, instead of two projections  83 ′ as in the second embodiment. Correspondingly, the receiving part  5 ″ of the modified second embodiment has only one recess  11   c  on the bottom of the substantially U-shaped recess  11  for engagement with the only one projection  83 ″. Further, as shown in  FIGS. 18 ,  20  and  21 , a recess  13  is provided which extends from the recess  11   c  in a circumferential direction substantially for a quarter circle length. Hence, the projection  83 ″ of the pressure element  8 ″ is guided in the recess  13  when the pressure element  8 ″ is rotated to align the U-shaped recesses. The projection  83 ″ abuts against the upper edge of the recess  13  which acts as a stop. Further, the projection  83 ″ abuts against the end of the recess  13  in a circumferential direction, which prevents further rotation of the pressure element  8 ″ as shown in  FIG. 23 . 
         [0062]    A third embodiment of the bone anchoring device will now be described with reference to  FIGS. 24 to 26 . 
         [0063]    The third embodiment differs from the first and the second embodiment in the design of the pressure element and the receiving part. In the third embodiment, a coupling between the pressure element  8 ′″ and the receiving part  5 ′″ which prevents the falling out of the pressure element  8 ′″ is a threaded coupling. Parts of the receiving part  5 ′″ and the pressure element  8 ′″ according to the third embodiment which are similar to those of the first and second embodiments are indicated with the same reference numerals, and the descriptions thereof are not repeated. The pressure element  8 ′″ differs from the pressure elements according to the second embodiment in that instead of the projections  83 ′/ 83 ″ a section  830  with a fine thread is provided at a lower end of the substantially cylindrical section  81 . The height of the section  830  in an axial direction is small compared to the height of the substantially cylindrical section  81 . The thread can be for example a metric fine thread or any other thread. 
         [0064]    The receiving part  5 ′″ has, instead of the portion  9   c  with the reduced diameter of the bore  9  according to the bone anchoring devices of the first and second embodiments, a corresponding threaded section  930  of the bore  9  which cooperates with the threaded section  830  of the pressure element  8 ′″. 
         [0065]    When the pressure element  8 ′″ is inserted into the receiving part  5 ′″ and the threaded section  830  is screwed through the threaded section  930  with the internal thread so that it enters the enlarged diameter section  9   b , the section  930  having the internal thread acts as a stop which prevents escape of the pressure element  8 ′″ through the top end  5   a . As in the first and second embodiments, the securing against falling out is achieved by first inserting the pressure element  8 ′″ and then rotating it. In the third embodiment the rotation is realized by screwing the pressure element  8 ′″ through the section  930  with the internal thread. 
         [0066]    Further modifications of the bone anchoring device are conceivable. For example, instead of the pressure element having the projections as described in the first and second embodiments, the receiving part can instead have the projections, which engage in corresponding recesses provided at the pressure element. 
         [0067]    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.