Abstract:
Disclosed are surgical devices and methods of proximating body parts. In an exemplary method of assembling an orthopedic prosthetic device, there are steps o placing a ferrule in a sleeve; passing a cord through the sleeve and through the ferrule; applying pressure to the ferrule, to cause the ferrule to grip the cord; and locking the ferrule in a fixed position relative to the sleeve.

Description:
FIELD OF THE INVENTION  
       [0001]    This invention relates generally to surgical kits and methods and, more particularly, to surgical kits and methods for resisting a tensile force in order to maintain body parts in proximity. 
       DESCRIPTION OF RELATED ART  
       [0002]    An orthopedic prosthetic device can rely on a flexible tensioned element to maintain approximation of two or more body parts, such as bones. The flexible tensioned element can be made of metal cable or cordage that is a composite of a tough cover, such as polyester, and a core with high tensile strength and low creep, such as an Aramid fiber. For example, an orthopedic implant can include a metal flange connected to a cord at one end, the cord passing through a bone and then through or around a second bone and tied to a second metal flange thereby holding the two bones together. 
         [0003]    The effectiveness of such a device may be limited by the wearing out of the cord over time. 
       SUMMARY OF THE INVENTION 
       [0004]    To address the problem above, there is a method of assembling an orthopedic prosthetic device. The method comprises placing a ferrule in a sleeve; passing a cord through the sleeve and through the ferrule; applying pressure to the ferrule, to cause the ferrule to grip the cord; and locking the ferrule in a fixed position relative to the sleeve. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0005]    References are made to the following text taken in connection with the accompanying drawings, in which: 
           [0006]      FIG. 1  shows a combination of elements. 
           [0007]      FIG. 2  shows a process. 
           [0008]      FIG. 3  shows a subsequent phase of the process. 
           [0009]      FIG. 4  shows a process in accordance with an exemplary embodiment of the present invention. 
           [0010]      FIG. 5  shows a subsequent phase of the process. 
           [0011]      FIG. 6  shows a subsequent phase. 
           [0012]      FIG. 7  shows a subsequent phase. 
           [0013]      FIG. 8  shows a subsequent phase. 
           [0014]      FIG. 9  is a diagram emphasizing a sub process. 
           [0015]      FIG. 10  is a diagram showing a subsequent phase of the process. 
           [0016]      FIG. 11  is a cross section view emphasizing certain aspects of the configuration shown in  FIG. 10 . 
           [0017]      FIG. 12  shows a process in accordance with a second exemplary embodiment. 
           [0018]      FIG. 13  shows a subsequent phase of the other process. 
           [0019]      FIG. 14  shows a subsequent phase. 
           [0020]      FIG. 15  shows a subsequent phase. 
           [0021]      FIG. 16  shows a subsequent phase. 
           [0022]      FIG. 17  is a diagram showing a subsequent phase of the process. 
           [0023]      FIG. 18  is a cross section view emphasizing certain aspects of a configuration. 
           [0024]      FIG. 19  is a cross section view of the configuration shown in  18  at a subsequent time point. 
           [0025]      FIG. 20  shows a process in accordance with a third exemplary embodiment. 
           [0026]      FIG. 21  shows a subsequent phase of the other process. 
           [0027]      FIG. 22  shows a subsequent phase. 
           [0028]      FIG. 23  shows a subsequent phase. 
           [0029]      FIG. 24  shows a subsequent phase. 
           [0030]      FIG. 25  is a diagram showing a subsequent phase of the process. 
           [0031]      FIG. 26  is a diagram emphasizing certain aspects of the configuration shown in  FIG. 25 . 
       
    
    
       [0032]    The accompanying drawings which are incorporated in and which constitute a part of this specification, illustrate embodiments of the invention and, together with the description, explain the principles of the invention, and additional advantages thereof. Certain drawings are not necessarily to scale, and certain features may be shown larger than relative actual size to facilitate a more clear description of those features. Throughout the drawings, corresponding elements are labeled with corresponding reference numbers. 
       DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS  
       [0033]      FIG. 1  shows a sleeve  122 . The sleeve  122  defines internal threads  124  and a flange  126 . 
         [0034]    The ferrule  130  has a plurality of tapered segments. The ferrule  130  is configured to fit into the sleeve  122 . 
         [0035]    The set screw  140  defines external threats  142  that mate with internal threads  124  of the sleeve  122 . The set screw  140  defines a plurality of indents  144  for engagement with a screwdriver, as described in more detail later in this disclosure. 
         [0036]      FIG. 2  shows a process performed in a factory building. A plurality of sleeves  122  are placed into a sterilizer  142 . The sterilizer  142  could include an oven that heats to a temperature of 100 degrees Celsius or more, in order to sterilize the sleeves  122 . Subsequently, each sleeve  122  is placed in a respective sterile envelope  126  and the envelope  126  is then hermetically sealed, such that the sleeve  122  is sterile in a sterile interior of the envelope  126 . Each envelope  126  contains one and only one sleeve  122 . 
         [0037]    A plurality of the ferrules  130  are placed into a sterilizer  142  and heated to a temperature of  100  degrees Celsius or more, in order to sterilize the ferrules  130 . Subsequently, each ferrule  130  is placed in a respective sterile envelope  136  and the envelope  136  is then sealed hermetically sealed, such that the ferrule  136  is sterile in a sterile interior of the envelope  136 . Each envelope  136  contains one and only one of the ferrules  130 . 
         [0038]    A plurality of set screws  140  are placed into a sterilizer  142  and heated to a temperature of 100 degrees Celsius or more, in order to sterilize the set screws  140 . Subsequently, each set screw  140  is placed in a respective sterile envelope  146  and the envelope  146  is then sealed hermetically sealed, such that the set screw  140  is sterile in a sterile interior of the envelope  146 . Each envelope  146  contains one and only one set screw  140   
         [0039]      FIG. 3  shows another process performed in the factory building. An envelope  126 , an envelope  146 , and an envelope  136  are placed in a common box  150 . The box  150  has one and only one envelope  126 , one and only one envelope  146 , and one and only one envelope  136 . 
         [0040]    The sterilizer  142  could include a mechanism configured to apply a chemical, physical, and/or irradiation method. Examples of chemical methods include exposure to ethylene oxide or hydrogen peroxide vapor. Examples of physical methods include sterilization by heat. Examples of irradiation methods include gamma irradiation, electron beam irradiation, and microwave irradiation. 
         [0041]      FIG. 4  shows a process, performed outside of the factory building, in accordance with an exemplary embodiment of the present invention. An electric drill  167  is applied to a clavicle  21  in order to make a through-hole  23 . Subsequently, the electric drill  167  is applied to the clavicle  21  in order to make a through-hole  25 . 
         [0042]    As shown in  FIG. 5 , a flange  118  is placed over the clavicle  21  such that a hole  123  of the flange  118  is aligned with the through-hole  23  of the clavicle  21  and a hole  125  of flange  118  is aligned with the through-hole  25  of clavicle  21 . A cord  115  with fixed end stop  110  is passed through the through-hole  125  and the hole  25 , then around a coracoid process  19  of a scapula  17 , and then through the through-hole  23  and the hole  123 . 
         [0043]    As shown in  FIG. 6 , the envelope  126  is removed from the interior of the box  150  and the sleeve  122  removed from the sterile interior of the envelope  126 . The envelope  126  is then discarded. The envelope  146  is removed from the interior of box  150  and set crew  140  removed from the sterile interior of the envelope  146 . The envelope  146  is then discarded. The envelope  136  is removed from the interior of the box  150  and the ferrule  130  removed from the sterile interior of envelope  136 . The envelope  136  is then discarded. 
         [0044]    As shown in  FIG. 7 , the cord  115  is passed through the sleeve  122 , through the ferrule  130 , and though the set screw  140 . Once the end of cord  115  has exited the through-hole  23  in the clavicle  21 , sufficient traction is applied to the cord  115  so as to seat trailing flange assembly  110  against the flange  118 . With the sleeve  122  seated against the flange  118 , traction is applied to the cord  115 , so as to restore alignment of the clavicle  21 . 
         [0045]    Pressure is applied to the ferrule  130  via the set screw  140 , to cause the ferrule  130  to grip the cord  115  and to lock the ferrule  130  in a fixed position relative to the sleeve  122  as shown in  FIG. 8 . 
         [0046]      FIG. 9  shows a tool applying a turning force to the set screw  140  in order to apply pressure to the ferrule  130 . A cannulated (hollow) screwdriver  170  includes teeth  171 . The teeth  171  engage with the detents  141  of the set screw  140 . 
         [0047]    As shown in  FIG. 10 , the cord  115  is then cut flush with the surface of the adjustable and stop. 
         [0048]      FIG. 11  is a diagram emphasizing certain aspects of the configuration shown in  FIG. 10 . The external threads  142  of the set screw  140  engage internal threads  124  of sleeve  122 , causing the set screw  140  to exert a force downward, in the orientation of  FIG. 11 , onto the ferrule  130 . 
         [0049]    The tapered portions of the sleeve  122  act as an inclined plane relative to the downward force on the ferrule  130 , causing the ferrule  130  to exert a compressive force inward towards the axis of the cord  115 . The compressive force is applied across a distance D. The distance D exceeds the diameter of the cord  115 . In other words, the distance D is more than  100  percent of the diameter of cord  115 . For example, if the cord the  115  has a diameter of  1  millimeter, the distance D is greater than 1 millimeter. 
         [0050]    The cord  115  has a diameter in the range of 1 to 10 millimeters 
         [0051]    Because of the compression along the distance D, the cord  115  is held in place within the sleeve  122 , despite a tensile force key exerted by bone and tissue. 
         [0052]    In summary, the box  150  contains a surgical kit including a hermitically sealed package  126  having a sterile interior, a sterile sleeve  122  in the interior of the package  126 . The sleeve is configured to receive the ferrule  130  and the ferrule is configured to receive the cord  115 , such that the cord  115  extends from the sleeve  122  along the sleeve axis, and extends from the ferrule  130  along the ferrule axis. A section of the internal threads  124 , of sleeve  122 , is effectively a projection configured to exert a force, parallel to the sleeve  122  axis, against the ferrule  130 , via the set screw  140 . 
         [0053]    The pressure applied via the set screw  140  causes the ferrule  130  to grip the cord  115  along a certain minimum length D of the cord, and lock the ferrule  130  in a fixed position relative to the sleeve  122 . 
         [0054]      FIGS. 12-14  show a process, performed outside of the factory building, in accordance with another exemplary embodiment. A long straight needle  107  engages the cord  115  and is passed through the through-hole  105  and out the intact medial skin. 
         [0055]    Once the needle  107  has exited the medial tibia  5 , sufficient traction is applied to the cord  115  so as to seat the trailing flange assembly  110  against the fibula 
         [0056]    As shown in  FIG. 15 , the envelope  126  is removed from the interior of box  150  and the sleeve  122  removed from the sterile interior of envelope  126 . The envelope  126  is then discarded. The envelope  146  is removed from the interior of box  150  and set crew  140  removed from the sterile interior of envelope  146 . The envelope  146  is then discarded. The envelope  136  is removed from the interior of box  150  and the ferrule  130  removed from the sterile interior of envelope  136 . The envelope  136  is then discarded. 
         [0057]    As shown in  FIG. 16 , the cord  115  is passed through the sleeve  122 , through the ferrule  130 , and though the set screw  140 . The sleeve  122  is seated against the medial tibia  5 . Traction is applied to the cord  115 , so as to position the medial tibia  5  relative to the fibula  10 . 
         [0058]    Pressure is applied to the ferrule  130  via the set screw  140 , to cause the ferrule  130  to grip the cord  115  and to lock the ferrule  130  in a fixed position relative to the sleeve  122  as shown in  FIG. 17 . 
         [0059]      FIG. 18  shows a configuration. A long straight needle  107  engages the cord  115  and is passed through the through-hole  105  and out the intact medial skin. 
         [0060]    Once the needle  107  has exited the medial tibia  5 , sufficient traction is applied to the cord  115  so as to seat trailing flange assembly  110  against fibula  10 . 
         [0061]    The cord  115  is passed through the sleeve  222 , through the ferrule  230 , and though the set screw  240 . The sleeve  222  is seated against medial tibia  5 . Traction is applied to cord  115 , so as to position medial tibia  5  relative to fibula  10 . 
         [0062]    Subsequently, as shown in  FIG. 19 , pressure is applied to the ferrule  230  via the set screw  240 , to cause the ferrule  230  to grip the cord  115  and to lock the ferrule  230  in a fixed position relative to the cord  115 . 
         [0063]    More specifically, external threads  242  of the set screw  240  engage internal threads  224  of the sleeve  222 , causing the set screw  240  to exert a force downward, in the orientation of  FIG. 19 , onto the ferrule  230 . 
         [0064]    The downward force causes the ferrule  230  to collapse in the vertical direction, as the ferrule  230  is compressed between screw  240  and sleeve  222 . The collapse of the ferrule  230  causes the ferrule  330  to expand in the horizontal direction, in the orientation of  FIG. 19 . Because the side of sleeve  222  is rigid, the ferrule  230  undergoes a horizontal expansion in a direction towards the axis of cord  115 , causing the ferrule  230  to insert a compression inward towards the axis of cord  115 . The compression force is applied across a distance D along the axis of the cord  115 . The distance D exceeds the diameter of the cord  115 . In other words, the distance D is more than 100 percent of the diameter of cord  115 . 
         [0065]    Because of the compression along the distance D, cord  115  is held in place within sleeve  222 , despite a tensile force key exerted by bone and tissue. 
         [0066]    To more evenly distribute the compressive force, the distance D, along the axis of the cord  115 , is greater than 2 times of the diameter of cord  115 . 
         [0067]    To still more evenly distribute the compressive force, the distance D, along the axis of the cord  115 , is greater than 5 times of the diameter of cord  115 . 
         [0068]    To still more evenly distribute the compressive force, the distance D, along the axis of the cord  115 , is greater than 10 times of the diameter of cord  115 . 
         [0069]    In summary, the sleeve  222  is configured to receive the ferrule  230  and the ferrule  230  is configured to receive the cord  115 , such that the cord  115  extends from the sleeve  222  along the sleeve axis, and extends from the ferrule  230  along the ferrule axis. A section of the internal threads  224 , of sleeve  222 , is effectively a projection configured to exert a force, parallel to the sleeve  222  axis, against the ferrule  230 , via the set screw  240 .The pressure applied via the set screw  240  causes the ferrule  230  to grip the cord  115  along a certain minimum length D of the cord, and lock the ferrule  230  in a fixed position relative to the sleeve  122  and relative to cord  115 . 
         [0070]      FIGS. 20-22  show a process performed, outside of the factory building, in accordance with another exemplary embodiment. A long straight needle  107  engages cord  115  and is passed through the through-hole  105  and out the intact medial skin. 
         [0071]    Once the needle  107  has exited the medial tibia  5 , sufficient traction is applied to cord  115  so as to seat trailing flange assembly  110  against fibula  10 . 
         [0072]    As shown in  FIG. 23 , envelope  126 ′ is removed from the interior of box  150 ′ and sleeve  322  removed from the sterile interior of envelope  126 . Envelope  126 ′ is then discarded. Envelope  136 ′ is removed from the interior of box  150 ′ and the ferrule  330  removed from the sterile interior of envelope  136 ′. Envelope  136 ′ is then discarded. 
         [0073]    As shown in  FIG. 24 , the cord  115  is passed through the sleeve  322 , and through the ferrule  330 . The sleeve  322  is seated against medial tibia  5 . Traction is applied to cord  115 , so as to position medial tibia  5  relative to fibula  10 . 
         [0074]    With no force applied, the ferrule  330  is wider than the aperture of sleeve  322 . The surgeon inserts the narrow end of the ferrule  330  into the aperture of sleeve  322 . The surgeon then exerts a pressure on the ferrule  330  along the axis of sleeve  322 , causing the ferrule  330  to undergo the deformation in order to pass through the aperture of sleeve  322  such that the ferrule  330  undergoes elastic recovery (spring back), and the ferrule  330  is seated in sleeve  322 , with the projection  152  of sleeve  322  exerting a pressure, on the projection  162  of the ferrule  330 , along the axis of sleeve  322 , to cause the ferrule  330  to grip the cord  115  and to lock the ferrule  330  in a fixed position relative to the sleeve  322  as shown in  FIG. 25 , where the ferrule  330 -sleeve  322  combination is designated  120 ′. 
         [0075]      FIG. 26  is a diagram emphasizing certain aspects of the configuration shown in  FIG. 25 . Projection  152  of sleeve  322  engages projection  162  of the ferrule  330  such that sleeve  322  exerts a force downward, in the orientation of  FIG. 26 , onto the ferrule  330 . 
         [0076]    The tapered portions of the sleeve  322  act as an inclined plane relative to the downward force on the ferrule  330 , causing the ferrule  330  to insert a compression inward towards the axis of cord  115 . The compression force is applied across the distance D. 
         [0077]    Because of the compression along the distance D, cord  115  is held in place within sleeve  122 , despite a tensile force key exerted by bone and tissue. 
         [0078]    In summary, box  150 ′ contains a surgical kit including a hermitically sealed package  126 ′ having a sterile interior, a sterile sleeve  322  in the interior of the package  126 ′. The sleeve is configured to receive the ferrule  330  and the ferrule is configured to receive the cord  115 , such that the cord  322  extends from the sleeve  322  along the sleeve axis, and extends from the ferrule  330  along the ferrule axis. 
         [0079]    Sleeve  322  includes a projection  152  configured to exert a force, parallel to the sleeve  322  axis, against the ferrule  330 . 
         [0080]    The projection  152  extends from a detent defining a ring-shaped structure in sleeve  322 . 
         [0081]    The projection  152  defines a  90  degree angle with the sleeve axis. 
         [0082]    The components  322  and  330  undergo the same factory building sterilization and packaging processes as already described above. 
         [0083]    Benefits, other advantages, and solutions to problems have been described above with regard to specific examples. The benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not critical, required, or essential feature or element of any of the claims. 
         [0084]    Additional advantages and modifications will readily occur to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or the scope of Applicants&#39; general inventive concept. The invention is defined in the following claims. In general, the words “first,” “second,” etc., employed in the claims do not necessarily denote an order.