Abstract:
A system to be used with an implanting tool having a tip part. The system has a longitudinal axis and includes a polymeric screw having a head and an adapter between the screw and the implanting tool. The adapter includes a first part that fits the tip part of the implanting tool.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of U.S. patent application Ser. No. 11/802,692 filed 24 May 2007, which claims priority to Finnish patent application 20065349 filed 24 May 2006, the entire contents of both of which are hereby incorporated by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to a system to be used with an implanting tool. There is a special adapter between a polymeric screw to be screwed and the implanting tool. 
       BACKGROUND 
       [0003]    Metallic screws have been used for tissue fixation in surgical procedures since the  1940 &#39;s. Metallic screws preferably made of stainless steel or titanium are still most commonly used in surgery. Metallic materials, however, are significantly stiffer than bone or other tissues in human body. This mechanical incompatibility of the fixation device with the healing tissue generates several problems, such as a stress shielding effect, the loosening of the fixation due to micro motion on the implant tissue interface, and the local necrosis of the tissue due to too high local stresses in the tissue. Additionally, long term complications due to the corrosion products of the fixation devices are not uncommon. 
         [0004]    Bioabsorbable fixation devices theoretically overcome all the above mentioned problems related to metallic fixation devices. The modulus of the polymer materials can be tailored to be nearly equivalent with the tissues related to a specific application, which leads to accelerated healing due to biomechanically optimised stress transfer to the healing tissue. Bioabsorption, on the other hand, diminishes the risk of long term complications. 
         [0005]    Bioabsorbable fixation devices have not replaced the metallic fixation devices used in surgery as was expected already years ago. There are several reasons for that, such as the lack of confidence on the bioabsorbable products among the clinicians used to perform the operations with metallic devices, and in some cases, the more demanding surgical technique related to the use of the bioabsorbable fixation device. In the case of bioabsorbable fixation screws, the screw head design is strongly limited by the mechanical properties of the bioabsorbable polymer materials. The material properties of bioabsorbable polymers do not allow the usage of standardised bone fixation screw heads, e.g. hexagonal or torx heads. 
         [0006]    Most surgical screws have been made of metallic materials, e.g. titanium or stainless steel. These screws have multiple thread and head configurations to be used with different kinds of instrumentation. To ease the work of the orthopaedic surgeons, AO/ASIF (Arbeitsgemeinschaft für Osteosynthesefragen/Association for the Study of Internal Fixation) has published proposed configurations of general surgical screws to unify the instruments used in surgery. The surgeons could then use the same instrumentation, drills, taps etc. with implants of different manufacturers, if the implants have been made according to the AO/ASIF proposal. The proposal has also been turned to the ISO standards ISO 5835, ISO 6475 and ISO 9268 and to the ASTM standards ASTM F116-00 and ASTM F543-02. 
         [0007]    The AO/ASIF proposal comprises multiple different shapes for the slot of the screw head, such as cruciform, square and hexagonal. The most used one is the hexagonal head. There are also holding sleeves to be attached to the screwdriver, which holds the screw in the driver during the implantation. The AO/ASIF screwdrivers with the holding sleeves have been designed to be used with standard screws. 
         [0008]    There are also bioabsorbable screws in use, which are absorbed in the human body after the implantation so that a removal operation is not needed. The problem with AO/ASIF compatible instruments and bioabsorbable screws is that the instruments have been designed to be used with metallic implants. The mechanical properties of the bioabsorbable screws are not adequate to be able to use the AO/ASIF instruments with them. Usually, the bioabsorbable screws have to be implanted with appropriate instrumentation that increases the costs of the operations. Adapters which have been attached to the screw but which only fit the appropriate instruments, have been invented in several cases, see for example U.S. Pat. No. 5,971,987 and EP 0276153. Also, an adapter that fits between the screw and the AO/ASIF instrument has been invented, see U.S. Pat. No. 5,868,749, but the invention has not included the holding sleeve that should also fit the adapter, to be used with it. Moreover, the adapter in question is intended to be used only with screws made of bone substance. 
         [0009]    The other problem with the use of bioabsorbable screws is the breaking off of the screw when twisted with the screwdriver. Because surgeons are used to applying metallic screws that can withstand much more torque, the shift to bioabsorbable screws often results in using excessive torque with them. There are torque-limiters invented to be used with both metallic and bioabsorbable screws. Some of them are mechanisms built in the screwdrivers so that the driver gives in when twisted with too much torque (see U.S. Pat. No. 6,132,435). The forces of such torque-limiters have been adjusted to metallic screws and cannot be used with bioabsorbable ones. In many cases, they have also been designed to be used with electrical screwdrivers, which are not appropriate for bioabsorbable screws because it is important to use manual drivers to maintain a better response when tightening bioabsorbable screws. There are also torque-limiters for metallic and bioabsorbable screws that are integrated in the screw (see EP 0276153 and U.S. Pat. No. 6,471,707). They function so that there is a weaker score in the screw head for the purpose that the head will break off when excessive torque is applied. The screw has to be tightened with a secondary instrument, if the screw has not been tightened enough until the head breaks off. Also, if the screw has been stuck, the secondary instrument has to be used to remove the screw. 
       SUMMARY OF THE INVENTION 
       [0010]    According the current invention, the screw can be inserted into the bone with the novel adapter design which enables the use of standard bone screw instruments with holding sleeves and still allows the use of the screw head design best suitable for the polymeric screw. The adapter can comprise one part or several parts. The uppermost part has the standard screw head design and is preferably made of metal. The lowest side of the adapter will fit to a screw head design that is not standardised but optimized for a polymeric bone fixation screw. The lower part may be made of metal and/or plastics. Between the upper and lower parts there is a special junction which limits the maximum torque and which can be transferred from the uppermost part to the lower part in order to avoid breaking of the bioabsorbable polymer screw breakage during the surgical procedure, if a surgeon, who is used to inserting stronger metallic screws, uses too high a torque during the installation. The design of the junction is such that it enables the removing of the screw from the bone even if the torque-limit has been exceeded during the tightening of the screw. The adapter can be attached to the screw head with a mechanical quick coupling so that it holds the screw firmly during the insertion, but after the screw has been tightened enough, the adapter can be easily detached with the screwdriver. 
       GENERAL DESCRIPTION OF THE INVENTION 
       [0011]    The system is to be used with fixation screws, such as bioabsorbable fixation screws. The system is intended to be used with an implanting tool having a tip part. The system comprises an adapter comprising a first part, and a polymeric screw. The adapter may comprise a second part. The system is elongated and has a longitudinal axis. The head of the first part fits the tip part of the implanting tool, e.g. a special screwdriver. The second part of the adapter is compatible with the head of the polymeric screw. 
         [0012]    When the adapter comprises the second part, the first and the second parts of the adapter are connected to each other with a torque limiting junction. The torque limiting junction allows the first part to rotate with respect to the second part and the polymeric screw when the predetermined maximum torque has been exceeded during the screwing of the polymeric screw. However, when the polymeric screw is screwed off, i.e. when the tensioning of the polymeric screw is loosened, the first and the second parts do not rotate with respect to each other. Therefore, the polymeric screw can be screwed off although it cannot be tightened any further. 
         [0013]    The first part of the adapter comprises a head and a shaft which axis is concentric to the longitudinal axis of the system. The head usually has a larger diameter than the shaft. The head comprises a spot which is compatible with the implanting tool. The spot can be a suitably shaped recess, for example a hexagonal, cruciform, hexalobular, or quadratic recess, or the recess is a single slot. In the end of the shaft there is an end part which forms a connection to the second part. 
         [0014]    On the surface of its periphery the shaft comprises a first element which counteracts with a second element in the second part. The first element and the second element together form a body which allows the rotation when the maximum torque is exceeded during the screwing and prevents rotating when the screw is screwed off. The first element may comprise suitably shaped ridges which are provided around the periphery of the shaft. The ridges are shaped so that they can operate in above-described manner in connection with the first element. The number of the ridges or teeth can vary. The ridges can be teeth of a pinion. 
         [0015]    The second part is concentric with the longitudinal axis of the system. The second part comprises the second element which forms a counterpart to the first element. The second element may be a cavity whose shape corresponds to that of the first element. In the bottom of the cavity there may be a recess which is compatible with the end portion of the shaft of the first part of the adapter. 
         [0016]    The cavity is surrounded by walls which are separated from each other by at least one slot. The slot makes it possible that the walls can bend outwards when the first element has to rotate with respect to the second element. There are usually more than one slot, for example four slots. 
         [0017]    On the opposite side of the second part (in the length direction) there is a slot for fastening the polymeric screw. The slot is surrounded by forks which support the head of the screw from their side. The forks may comprise tabs on their inner surface. 
         [0018]    The polymeric screw is concentric with the longitudinal axis of the system and it is attached to the second part. The head of the polymeric screw is shaped so that it fits the slot of the second part. The head of the screw may comprise flutes which are compatible with the tabs. 
         [0019]    According to another modification, the first element comprises a pinion. The pinion comprises blades which extend towards the periphery of the pinion. The pinion is fastened to an end of a shaft which is compatible with a hole in the second part. 
         [0020]    The second element comprises walls whose upper side is bevelled in the screwing direction. The walls are placed radially and their height becomes smaller towards the center of the second part. The underside of each blade is stepped so that the walls will grip the steps of the blades when the screw is screwed off. 
         [0021]    The materials, the dimensions and the shapes which are used in the adapter are selected so that the desired torque forces can be achieved. The materials are normally selected amongst metals or plastics. 
         [0022]    When the adapter does not comprise the second part, the second element is formed on the head of the polymeric screw. The head of the polymeric screw may comprise on its periphery cutting-ins which are compatible with the first element of the first part of the adapter. The first element may comprise fingers which grip the cutting-ins. The cutting-ins and the fingers are shaped so that when the maximum torque in the screwing-in direction is exceeded, it is possible to rotate the screw in the screwing off direction. 
         [0023]    According to another solution, the cutting-ins and the fingers may be shaped so that the maximum torque to both directions is substantially the same. In that case, the fingers and cutting-ins have symmetrical halves with respect to a vertical plane which divides the halves. 
         [0024]    The number and the shape of the fingers and the cutting-ins may vary but they always form counterparts. The fingers are adapted to grip the cutting-ins on the outer periphery of the head of the polymeric screw. The adapter is usually made of a metallic material. 
         [0025]    The adapter comprising the fingers has a large area which is in contact with the head of the polymeric screw. This feature is meaningful, for example, in connection with brittle bones, such as osteoporotic bones. 
         [0026]    Further, the system comprising the screw and the adapter also has other advantages. The head of the adapter is compatible with the tip part of the implanting tool. The head of the first part of the adapter may comprise, for example, a recess which is compatible with the tip part of the implanting tool. Thus, a tight and stable joint is achieved. Furthermore, there is no need to touch the system by hand so the aseptic conditions are well maintained on the surface of the system comprising the adapter and the polymeric screw. 
         [0027]    As a common feature for all modifications described in this application, there may be a canal for a guide wire. The canal is concentric with the system of the invention and extends through the system to the longitudinal direction of the system. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0028]      FIG. 1  shows a perspective view of a first part of the adapter, 
           [0029]      FIG. 2  shows a perspective view of a second part of the adapter, 
           [0030]      FIG. 3  shows a perspective view of a bioabsorbable screw, 
           [0031]      FIG. 4  shows a perspective view of an exploded assembly comprising parts of the system of the invention, 
           [0032]      FIG. 5  shows a perspective view of the system of the invention, 
           [0033]      FIGS. 6-8  and  10  and  11  show cross-sectional views of a torque limiting junction, 
           [0034]      FIG. 9  shows a perspective view of an adapter (a partial view), 
           [0035]      FIG. 12  shows schematic views of possible modifications of the system according to the invention, 
           [0036]      FIG. 13  shows a perspective view of an adapter (a partial view), 
           [0037]      FIG. 14  shows a view of the adapter of  FIG. 13  in extended position, 
           [0038]      FIG. 15  shows a perspective view of the system of the invention, 
           [0039]      FIG. 16  shows a view of the system of  FIG. 15  in extended position, and 
           [0040]      FIG. 17  shows a top view of a head of a polymeric screw. 
       
    
    
     DETAILED DESCRIPTION 
       [0041]    An example of the first part of the adapter is shown in  FIG. 1 . The head of the first part comprises a hexagonal slot  1  that fits the AO/ASIF hexagonal screw driver. The first part  32  is also formed in the shape of an AO/ASIF metallic screw head so that it fits the screw holding sleeve  2 . In the middle of the first part  32 , there are ridges  3  that form part of the torque-limiting element. The sequential ridges  3  are on the periphery of a shaft  34 . The ridges  3  are shaped so that they allow torsion in the clockwise direction when the maximum torque to the clockwise direction is exceeded, but grip the counterpart when the first part is turned in counterclockwise direction (in this case, the polymeric screw is screwed to the clockwise direction and screwed off in the counterclockwise direction). In this case, the ridges incline in the counterclockwise direction, i.e. in the screwing-off direction. The end portion  4  of the first part is formed so that it attaches firmly to a recess  8  in the counterpart. 
         [0042]    The counterpart of  FIG. 1 , i.e. the second part  33 , is shown in  FIG. 2 . There is a cavity  5  of the same form as in  FIG. 1  so that the ridges  3  fit inside the part. There are four bending walls  6  that allow the torque-limit to function with the clockwise torsion. The four bending walls are separated with four slots  7 . The counterpart, i.e. the first part  32 , fits the recess  8  in the middle of the second part  33 . The other end of the part has two forks  9  that fit the bioabsorbable screw head. Small tabs  10  allow the part to attach firmly to the screw so that the adapter only comes off with a bending motion. 
         [0043]    The polymeric screw  31  is shown if  FIG. 3 . The head  11  of the screw is formed to fit the adapter by two cuts  12  in both sides of the head. Flutes  13  that fit the tabs of the adapter attach the screw to the adapter. The screw comprises threads  14  and a core  15  underneath the threads below the head  11 . 
         [0044]    There is an exploded assembly of the screw-adapter combination in  FIG. 4 . The different parts are positioned in their proper places before the assembly. The built up adapter-screw is shown in  FIG. 5 . 
         [0045]    The  FIG. 6 . shows one modification of the torque-limiting part of the adapter. The shaped pinion  16  allows rotation in the clockwise direction and prevents it in counterclockwise direction (in this case, the polymeric screw is screwed to the clockwise direction and screwed off in the counterclockwise direction). The teeth of the pinion incline in the counterclockwise direction, i.e. in the screwing-off direction. The walls  17  around the pinion  16  restrict the rotation. The slots  18  allow the walls  17  to bend, and with the proper torque, allow the pinion  16  to turn. 
         [0046]    In  FIG. 7 . there is another modification of the torque-limiting part of the adapter. The shaped pinion  20  is shaped so it can bend walls  21  around it. The slots  22  allow bending of the walls  21  with the proper torque. The counterclockwise rotation is prevented by the blades  24  of the pinion  20  and the walls  21 . The blade  24  have a rounded edge and a rectangular edge. The rounded edges of the blades  24  allow the rotation when necessary but the rectangular edges prevents the rotation. 
         [0047]      FIG. 8  shows still another modification of the torque-limiting part of the adapter. On the shaft  34  of the first part of the adapter there are blades  36  which have rounded edges and incline in the screwing-off direction. The shape of the blades allows the rotation in the clockwise direction and prevents it in the counterclockwise direction (in this case, the polymeric screw is screwed in the clockwise direction and screwed off in the counterclockwise direction). In this case, the blades have rounded edges. Walls  35  keep the blades  36  in their position but when the torsional force is high enough the walls  35  bend and allow the rotation. In the current modification, the walls  35  are individual columns as shown in  FIG. 9 . 
         [0048]      FIG. 10  shows blades  37  which are formed on the shaft  34  and walls  36 . The blades comprise a rounded edge and a rectangular edge. The function of the adapter is the same as described also in connection with the other figures. 
         [0049]      FIG. 11  shows blades  38  which are formed on the shaft  34  and walls  39 . The blades have rounded edges and incline in the screwing-off direction. The function of the adapter is the same as described also in connection with the other figures. 
         [0050]      FIG. 12  shows different modifications of the instrument-adapter-screw junctions. The screw  25  can be attached to the adapter  26  with a male or female connection. Simultaneously the instrument  27  can be attached to the adapter  26  with a male or female connection. 
         [0051]      FIGS. 13 and 14  show still another modification of the torque-limiting part of the adapter. The first element comprises a laterally rotating pinion  40 . The pinion  40  comprises blades  41  which become larger towards the periphery of the pinion  40 . 
         [0052]    The second element comprises walls  42  whose upper side is bevelled in the screwing direction. The walls  42  are placed radially and their height becomes smaller towards the center of the second part. The underside of each blade is stepped so that the walls will grip the steps  43  of the blades  41  when the screw is screwed off. 
         [0053]    The first element also comprises a shaft  44  which is compatible with a hole  45  in the second element. When the shaft  44  is placed in the hole  45  the torque-limiting junction is accomplished. 
         [0054]      FIGS. 15 and 16  show a modification of the system of the invention. The system comprises the first part  32  of the adapter but the second part is omitted. The first element of the first part  32  comprises fingers  50 . The head of the polymeric screw  11  has cutting-ins  51  which serve as the second element. The fingers  50  and the cutting-ins  51  form counterparts. The fingers  50  bend outwards when the maximum torque in the screwing-in direction is exceeded. However, the screw  31  may still be screwed off if desired. 
         [0055]      FIG. 17  shows the head of the polymeric screw  31  shown in  FIGS. 15 and 16 . The periphery of the head comprises the cutting-ins  51  so that teeth  52  are formed therebetween. The teeth  52  incline in the screwing off direction. 
         [0056]    It is also possible that the fingers  50  and the cutting-ins  51  are shaped so that the maximum torque in both directions is substantially the same. For example, the teeth  52  illustrated in  FIG. 17  may be modified so that they are straight. 
         [0057]    The number and the shape of the fingers and the cutting-ins may vary. However, the fingers and the cutting-ins always form counterparts. 
         [0058]    A skilled person can readily construct other modifications in addition to those shown in  FIGS. 1-17  after seeing the principle of this invention. Further, it is possible to use both left-handed screws or right-handed screws and a skilled person will understand how to modify the adapter according to the screw to be used.