Abstract:
A threaded fastener for embedment into bone is disclosed. Threads are formed on cylindrical stock. The thread pattern features upper and lower surfaces. The upper surface includes (in section) two facets which intersect to form a “V” shaped contour and a lower surface which is undercut below an upper facet nearest a root of the fastener thread. The fastener includes a self-tapping cutter at a distal extremity and a driving head at its proximal extremity. The cylindrical stock contemplates two variants: it may be hollow from the proximal end to the self-tapping cutter or from the self-tapping cutter to its distal end. The self-tapping cutter is configured to feed bone shards into the hollow.

Description:
FIELD OF THE INVENTION 
       [0001]    A fastener for embedment in bone is constructed to be easily inserted and reliably retained in the bone. 
       BACKGROUND OF THE INVENTION 
       [0002]    Surgical procedures involving fasteners on skeletal structure presently suffer from several common frailties. One is the inability to accurately orient the fastener during insertion to keep the fastener from wandering. Bone interiors have a sponge like (cancellous) texture. Even with a predrilled pilot hole, fasteners still frequently skew off the axis of the pilot hole, making it difficult to register the fastener at its distal end with another instrumentality. 
         [0003]    Another frailty is the failure to provide a reliable thread portion that engages the bone of the patient in a manner which retards its working loose. Bone is a remarkable structure which varies both in hardness and elasticity as a function of both age and location. Loads on the fastener must accommodate not only these constraints but also the dynamics of forces generated by the patient in daily activities. 
         [0004]    The buttress thread is presently the industry standard. Unfortunately, buttress threads are suitable for use only where load forces on the fastener are applied in one direction. (Bhandari, Design of Machine Elements (2007), page 204). Where the load forces are multidirectional or not unidirectional and axial, failure can occur. One manifestation of buttress thread failure is “toggling” where the fastener works on the bone and enlarges the hole within which the fastener resides. 
         [0005]    Yet another frailty related to high insert torque makes it impossible to insert the screw through bone fragments without it grabbing the fragment and causing it to rotate with the screw causing significant trauma to soft tissues and a failed fixation of the fragment. 
         [0006]    In an attempt to offset the multiple problems of buttress threads, it is common practice to design the buttress thread profile to increase retention by increasing friction. Increased friction leads to elevated temperatures during insertion, potentially damaging bone tissue. A temperature excursion greater than 116 degrees Fahrenheit (47 degrees Celsius) at the insertion site causes osteonecrosis which cannot be repaired and which the body cannot heal. And, even worse, excess heat compromises the fastener&#39;s ability to remain in place since the bone has died at the screw thread interface. As a consequence, some procedures rely on liquid cooling at the site during the drilling/insertion procedure, but, even then, the process generates so much heat that the heat generating tool can be too hot to touch because the liquid cooling is merely topical. 
         [0007]    Since the only variables (thread pitch, crest and root diameters) in the buttress thread design are interrelated, improving retention increases friction and insertion torque, resulting in heat generation and impairing the surgeon&#39;s ability to feel the insertion torque of the fastener in a meaningful way. This still leaves the fundamental problem of the thread&#39;s inability to withstand multidirectional forces unaddressed, while creating several new problems. 
         [0008]    The surgeon has no tactile feedback when inserting the fastener. The buttress fastener is harder to start and is prone to stripping, especially when used in conjunction with a plate. The wedge shaped buttress thread induces an outwardly radial force, perpendicular to the fastener&#39;s long axis, which increases the probability the bone will split or crack, making a procedure much more difficult, if not impossible. The buttress threaded fastener can wander during insertion, making its registry with an instrumentality at the distal end of the fastener a recurring problem. Wandering away from the pilot hole often results in cutting new threads in an unintended location or stripping out the pilot hole which retards healing and actually induces trauma; and, where there is a temperature excursion above 116 degrees Fahrenheit, it can also cause osteonecrosis of the adjacent bone. 
         [0009]    The present invention&#39;s thread geometry minimizes insertion force. This allows the surgeon tactile feedback and reduces the effort required to deploy the fastener. This, in conjunction with chip disposal, a centering pilot, and improved thread cutting features keep friction low, the fastener aligned and directed from wandering away from the preferred path. 
         [0010]    The distal end of many fasteners includes an area (cutting flute) designed to help cut through bone, defining a “self-tapping” fastener. Buttress thread fastener&#39;s self-tapping features a flute that is straight or at least close to in-line with the long axis of the screw. That is, as the fastener is advanced, the cutting edges send the bone chip towards the head of the fastener which is into the path of the helical threads. This bone debris accumulates along the thread teeth and increases insertion torque and friction which therefore generate additional heat. The debris also makes the fastener harder to insert and provides a poor interface with the bone and the fastener. 
         [0011]    In the present invention, the cut chips curl away from the cutting edges (located on one or more threads at the distal end) and are fed downwardly into a hollow of the fastener because of a chamfer at thread interruptions which define cutting surfaces or flutes. That is, as the fastener advances, the flute forces the chips downwardly into a hollow of the screw. This results in exact clearance between the fastener and the portion of the bone being formed as “bone teeth” (that portion which engages the threaded fastener). The interface between the bone and fastener is therefore substantially free of the cuttings and provides healthier bone tissue adjacent the fastener to prevent additional trauma to the bone. 
         [0012]    Another problem associated with buttress style threads is that the area between threads of the fastener is the only site of anchoring in the bone, and because of the design constraints associated therewith, this site is difficult to optimize. Stated alternatively, the metal of the fastener is orders of magnitude stronger than the retaining bone so that when failure occurs, it always involves bone trauma. 
         [0013]    The present invention maximizes the bone being engaged while minimizing the fastener&#39;s thread, something impossible to do with a buttress thread and other common threads and common manufacturing processes. The result is less bone trauma and less bone removed to increase bone strength to retain the fastener better. 
         [0014]    This invention discards conventional thinking and manufacturing processes in the pursuit of new and desirable functions that can be achieved from the thread profile. 
         [0015]    Heretofore manufacturers have adopted a simple and very fast manufacturing process that produce screws that function no better than common wood screws. 
       BRIEF SUMMARY OF THE INVENTION 
       [0016]    The present invention reflects results of applicant&#39;s ongoing research in threaded fasteners specialized for use in bone. Five thread patterns are disclosed, all of which function by “interlocking” with adjacent bone into which the fastener is embedded. The thread patterns may extend along the entire exterior length of the fastener or partially along the length. Two variations of a self-tapping cutter are disclosed: both of which feed cut bone shards into a hollow interior of the fastener: one cutter feeds shards into the interior towards a proximal end and another cutter feeds shards into a distal end. Thus, the interior is hollow either from the cutter towards the proximal end or from the cutter to its distal end. A pilot is located on the distal end. The self-tapping cutter is spaced a short distance from the pilot and the threads defining the cutter area decrease in crest diameter approaching the distal end of the fastener. Typically, one or more threads taper and the drawings show three such threads. 
         [0017]    The instant invention addresses various skeletal components with fasteners in ways heretofore unattainable with an improved thread pattern which provides greater retention of bone structure and minimal damage to bone adjacent the fastener. 
         [0018]    This invention produces a bone screw thread design that can be modified in many independent ways to produce different capabilities and functions that can contribute to better grip, greater resistance to pull-out, lower cutting and insertion pressure which reduces site temperature and causes less damage to the bone in the process. These features provide better feel for the surgeon installing the screws to prevent stripped threads, better clamping force, better fixation, and ultimately shorter healing time. 
         [0019]    The fastener is formed using a CNC manufacturing process which utilizes single-point threading in conjunction with multiple form cutting tools with different shapes and following different paths to create thread features formed by independently programmable successive cutting moves, each distinct from the others. This means that the tooth height, thickness and spacing can now each be modified independently to produce different characteristics and capabilities to greatly improve both the procedure when the screw is installed into the bone and the performance of the screw in situ. 
         [0020]    While the method that is being disclosed forms threads of greater complexity in the process, in a production setting it is only possible because of CNC machine tools and the ability to program sequential, independent cutting moves to create unique features unknown in the prior art. 
         [0021]    Bone fixation is very complicated because the breaks are found in an infinite variety of shapes and locations. Fasteners embedded in bone need to minimize bone trauma and removal while maximizing retention in a dynamic environment. The benefits derived from these new thread designs and a method to produce them will be very significant to the industry and patients. 
       OBJECTS OF THE INVENTION 
       [0022]    Accordingly, it is a primary object of the present invention to provide an orthopedic fastener structure and method. 
         [0023]    A further object of the present invention is to provide an improved threaded portion therefore. 
         [0024]    A further object of the present invention is to provide an improved threaded portion which minimizes bone trauma, resists failure and is easy to install. 
         [0025]    A further object of the present invention is to provide a fastener which can accommodate a plurality of different angles of attack when addressing a skeletal structure. 
         [0026]    Viewed from one vantage point, it is an object of the present invention to provide an orthopedic fastener formed by independently modifying tooth height, thickness and spacing, thus altering said faster&#39;s characteristics and capabilities. 
         [0027]    Viewed from another vantage point, it is an object of the present invention to provide an orthopedic fastener formed by: independently modifying tooth height, thickness and spacing, thus altering said fastener&#39;s characteristics and capabilities, whereby pitch and major and minor tooth thread diameters are independently variable to facilitate matching fastener thread profiles with corresponding bone tooth profiles as a function of bone density and site of fastener deployment to improve fastener purchase and increase resistance to pull out forces. 
         [0028]    Viewed from the previous vantage point, it is an object of the present invention to provide a fastener further including forming a chip cutting flute at a distal end thereof, said chip cutting flute having leading cutting edges defining a cutting thread pattern disposed on said distal end and spiraling helically on the fastener, said thread pattern disposed on said remainder of the fastener defining a substantially non cutting, interlocking thread pattern whereby said cutting flute forms the interlocking thread pattern in the bone thereby reducing friction upon fastener insertion and minimizing heat buildup while providing greater sensitivity during fastener installation, reducing installation torque and possible misalignment which otherwise causes unnecessary bone removal and thread stripping while resisting breaking loose bone fragments during installation. 
         [0029]    Viewed from the previous vantage point, it is an object of the present invention to provide a fastener further formed by disposing the interlocking thread pattern spirally along the fastener, interrupted by a substantially cylindrical fastener shaft such that said fastener shaft defines a cylindrical wall spiraling along a length of said fastener and interrupted by said interlocking thread pattern, whereby said interlocking pattern retards toggling of the fastener and minimizes radial forces while resisting multidirectional forces and bending moments which otherwise could cause fastener upheaval, and the cylindrical shaft defines a contact surface for bone devoid of sharp surfaces which would cause pressure points. 
         [0030]    Viewed from the previous vantage point, it is an object of the present invention to provide a fastener further forming an abutment surface adjacent a proximal end of said fastener, defining an impediment to further fastener advancement and means to induce clamping of said fastener in an orthopedic environment. 
         [0031]    Viewed from a previous vantage point, it is an object of the present invention to provide a fastener further forming an interference fit adjacent a proximal end of said fastener, defining an impediment to further fastener advancement and means to induce clamping of the fastener in an orthopedic environment. 
         [0032]    Another vantage point contemplates an orthopedic fastener, comprising, in combination: a shaft having a proximal end provided with means for advancing said fastener and means for impeding fastener advancement, said shaft having a thread pattern providing interlocking means wound about said shaft, said thread pattern interrupted by intervening smooth, cylindrical walls of said shaft, a thread forming means on a distal end of said shaft, said thread forming means having a thread pattern a mirror image of and opposite from said fastener thread pattern having said interlocking means, and a pilot at said distal end of said shaft adjacent said thread forming means, said thread forming means including means to store bone fragments interiorly and away from threads of said fastener. 
         [0033]    These and other object will become clearer when considering the following. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0034]      FIG. 1  shows a fastener with a thread along the cylindrical shaft. 
           [0035]      FIG. 2A  shows a cutter directing bone shards along one path. 
           [0036]      FIG. 2B  shows a cutter directing bone shards along another path. 
           [0037]      FIG. 3  shows a first tooth profile in section. 
           [0038]      FIG. 3A  shows one perspective of the  FIG. 3  cutting flute. 
           [0039]      FIG. 3B  shows a second perspective. 
           [0040]      FIG. 4  shows a second tooth profile in section. 
           [0041]      FIG. 4A  shows one perspective of the  FIG. 4  cutting flute. 
           [0042]      FIG. 4B  shows a second perspective. 
           [0043]      FIG. 5  shows a third tooth profile in section. 
           [0044]      FIG. 5A  shows one perspective of the  FIG. 5  cutting flute. 
           [0045]      FIG. 5B  shows a second perspective. 
           [0046]      FIG. 6  shows a fourth tooth profile in section. 
           [0047]      FIG. 6A  shows one perspective of the  FIG. 6  cutting flute. 
           [0048]      FIG. 6B  shows a second perspective. 
           [0049]      FIG. 7  shows a fifth tooth profile in section. 
           [0050]      FIG. 7A  shows one perspective of the  FIG. 7  cutting flute. 
           [0051]      FIG. 7B  shows a second perspective. 
           [0052]      FIG. 8  is a sectional view taken along the long axis of the fastener showing a hollow serving as a chip repository at a distal end. 
           [0053]      FIG. 9  is another longitudinal sectional view showing the hollow at the proximal end. 
       
    
    
     DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0054]      FIG. 1  depicts a plan view of a bone fastener  10  have a full flight of threads along its length;  FIG. 8  shows the fastener  10  in section and  FIG. 9  shows a modified fastener  10   a  having threads  12  only partially deployed and located at a distal end  14 , adjacent pilot  8 . The fastener shaft  6  above this threaded portion is smooth and cylindrical, as it is between all intervening threads. That is, the space between adjacent threads is cylindrical, thereby avoiding potential pressure points with adjacent bone. The fastener includes a head  2  at a proximal end that includes an instrumentality to facilitate fastener deployment, illustrated here as a female socket  4  to engage a complementally formed driving tool. 
         [0055]      FIGS. 8 and 9  also display two variations of the fastener  10 ,  10   a  internally.  FIG. 8  reflects a hollow bore  16  in communication between and open distal end  7  and a lower bore repository  80  located in a cylindrical periphery circumscribing and defining the bore  16 . This bore  80  is adjacent to and coextensive with the cutting flutes.  FIG. 9  reflects a hollow bore  18  extending from the proximal end and passing through the head  2  via socket  4  down to an upper bore repository  90  located on a cylindrical portion of the distal end adjacent cutting flutes. In this embodiment, it is preferred to close the distal end with a wall  14  defining a blind bore. The thread length shown in  FIGS. 8 and 9  could be transposed such that the abbreviated thread of  FIG. 9  could feed a lower bore repository shown in  FIG. 8  and the full thread  12  of  FIG. 8  could feed an upper bore repository  90  as shown in  FIG. 9 . 
         [0056]    In both fasteners, the distal end has a conical taper  8  diverging from the distal terminus and enlarging towards the cutting flutes where its diameter is equal to the shaft diameter. This taper discourages the fastener from wandering from a predrilled pilot hole. 
         [0057]    When the  FIG. 9  repository  90  is selected, it is possible to remove bone shards from the bore  18  and introduce additives into the bore  18  for dispensation about the bone/thread interface via the opening of the repository  90  that is adjacent the cutting flutes. Examples of additives include, but are not limited to: medicines, bone growth stimulants, and other substances having beneficial value. 
         [0058]      FIGS. 3 through 7  exemplify five thread forms having geometry optimized for retention in bone irrespective of the bone characteristics (e.g. cortical, cancellous, osteoporotic, variable density, variable elasticity, etc.). Upper inner root flanks (or facets) ( 32 ,  42 ,  52 ,  62  and  72 ) and upper outer flanks ( 33 ,  43 ,  53 ,  63  and  73 ) work in conjunction with lower undercut inner root flanks ( 34 ,  44 ,  54 ,  64  and  74 ) to provide primary thread retention in the adjacent bone. The conjunction of upper flanks form a substantially “V” shaped profile (when view in section) which centers and locates the bone by virtue of the crotch of the “V” and directs all loads imposed on the screw/bone interface to remain centered in place. In conjunction with the lower inner undercut root flank, all loads are resisted primarily by these three flanks and thwart migration of the fastener, preventing it from working loose. The lower inner root flank traps bone between it, the shaft and the adjacent upper flanks by threaded retention. 
         [0059]    All of the undercut lower root flanks—by definition of undercut—angle downwardly, from root attachment out and down towards the distal end. Because the upper root flanks also declinate downwardly towards the distal end, these two root flanks when viewed jointly tend to converge as they extend away from the root. 
         [0060]    Each thread pattern includes a lower, outer flank:  35 ,  45 ,  55 ,  65  and  75 . This lower outer flank extends from the lower undercut root flank.  FIGS. 3 through 7  reflect various angulations at the juncture of these lower flanks. Facets  45 ,  55 ,  65  and  75  appear substantially perpendicular to the long axis  11  of the fastener, while flank facet  35  is canted towards the proximal end of the fastener. 
         [0061]      FIG. 3  shows upper  33  and lower  35  outer flanks terminating at an outboard extremity in a crest diameter  36 , whose thickness is subject to modification from an appreciable thickness—as shown—to a minimal thickness approaching a thin edge, controlled by the machining process. As shown, crest  36  appears parallel to the long axis  11  ( FIG. 1 ) of the fastener. 
         [0062]    Similarly, crests  46 ,  56 ,  66  and  76  all appear parallel to the fastener long axis  11 . In  FIG. 4  an outermost portion of upper flank  43  registers with proximal edge of crest  46  while lower flank  45  registers with the distal edge of crest  46 . Comparing  FIGS. 3 and 4 , the proximal angulation of lower outer flank  35  represents a thinning of the material of the crest  36 . 
         [0063]      FIG. 5  includes a further upper flank  57  extending between an outer most portion of upper flank  53  and a proximal edge of crest  56 . A distal edge of crest  56  addresses lower outer flank  55 . Comparing tooth forms of  FIGS. 4 and 5 , flank  57  represents a chamfered surface, thinning the thickness of the crest  56 . 
         [0064]      FIG. 6  reflects the upper, outer flank  63  is parallel to both the crest  66  and the fastener long axis  11 . Consequently, a further outer facet  67  transitions between outer flank  63  and crest  66 . Transition facet  67  parallels lower outer facet  65  and both are perpendicular to the long axis of the fastener. The dimension of transition facet  67  is variable. 
         [0065]      FIG. 7  includes a transition facet  77  similarly oriented and dimensional as facet  67 , and the transition between a distal edge of the crest  76  and lower outer flank  75  enjoys a chamfer flank  78 . 
         [0066]    In each thread pattern shown in  FIGS. 3-7 , the active thread cutting geometry is shown in  FIGS. 3A-7A  and  3 B- 7 B with details shown in  FIGS. 2A and 2B  providing bone shard transport into repository bores  80  or  90 . While the  FIG. 2A  structure follows the  FIG. 3  geometry and  FIG. 2B  follows the  FIG. 6  geometry, none the less, it shall become clear the  FIGS. 4 ,  5  and  7  threads are to be affected in the same manner. 
         [0067]    Specifically, a hollow bore is created by drilling out the center of the fastener along the long axis  11  ( FIG. 1 ). If the hollow bore is on the distal end, a drill penetrates a distance into the fastener from the distal end. Conversely, when the hollow bore is on the proximal end, the drill enters from the proximal end  4 . Next, a broaching tool plunge cuts into the cylinder exterior at an angle offset from the long axis. The tooth pattern of  FIG. 2A  is achieved by cutting at a 5-10 degree angle  13 —offset from the long axis  11  shown in  FIG. 1 . This results in edges on upper flanks  133  and  135  contacting bone before edges on lower flanks  134  and  135 . This results in bone shards moving in the direction “A”, down into hollow  80  and towards the distal end. The broaching tool, when forming the oval opening for the hollow  80  also removes material from the oval  83  at the distal end as shown by ramp  81  in  FIG. 1 . This sloped ramp  81 , leading into the hollow, enhances the precision fit with the bone that is not removed. Sharp edges  82 , circumscribing the remainder of the oval  83  assure a further precise fit. 
         [0068]      FIG. 2B  reflects the broaching tool oriented along a 5-10 degree offset ( 15 ) on the opposite side of the long axis  11 . Please see  FIGS. 1 and 6 .  FIG. 2B  reveals the lower facets  164  and  165  will be the first to contact bone, sending bone shards along the arrow B, opposite from  FIG. 2A . Shards advance downwardly into the hollow  90  and thence towards the proximal end. Thus, it is to be observed that by changing the chamfer of the teeth where the broaching tool removed material, the bone shard removal pattern can be modified to either the proximal or distal interior of the fastener. 
         [0069]    For example, in  FIGS. 4A ,  5 A and  7 A, if the leading edges of the cutter are to be  144 ,  154  and  174  for the lower root flanks  44 ,  54  and  74 ; and  145 ,  155  and  175  for the lower outer flanks  45 ,  55  and  75 , then the  FIG. 2B  broaching technique is to be followed. Likewise, if the leading edges shown in  FIGS. 4B ,  5 B and  7 B are to be made effective, the  FIG. 2A  broaching step chamfers cutters  142 ,  143 ,  152 ,  153 ,  157 ,  172 ,  173  and  177  to lead the cutting. 
         [0070]    Other variants are contemplated as part of this invention by the scope of the claims.