Abstract:
A medical implant plate including at least two sets of apertures through an elongated shaft body to individually accommodate and orient set screws or pegs at various angles that may be selected depending on application, i.e., the apertures don&#39;t have fixed angled, but allow for a range of angles. Once the screw has been locked, the device becomes a fixed angled device. The screws or pegs laterally spaced relative to each other to resist torsion and to secure the plate against dislodgement. The body also includes a flared-end portion that accommodates and extends partially onto a metaphysis of a tubular bone of the hand while maintaining a low-profile to avoid soft-tissue irritation. The flared-end portion that extends on to the metaphysis does NOT have holes for screws but serves as a buttress. Screws that extend into the metaphysis come from the three holes located along the slightly angled portion of the plate.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application for patent claims the benefit of priority from U.S. Provisional Patent Application Ser. No. 61/026,725 filed Feb. 6, 2008, the disclosure of which is incorporated herein by reference in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present general inventive concept relates generally to a fracture fixation plate system, and more particularly, to a fracture fixation plate system designed to stabilize a fracture of a tubular bone of the hand. 
         [0004]    2. Description of the Related Art 
         [0005]    Plates having fixed-angled locking features are known for use with distal radius (wrist) fractures, proximal humerus (shoulder) fractures and some hand fractures. These plates have revolutionized the treatment of fractures that have occurred in comminuted and/or osteoporotic bone, providing rigid and stable internal fixation and allowing for early range of motion. 
         [0006]    Conventional wrist and shoulder plates have a raised head that extends onto the metaphysis of a bone to permit locking screws to extend into the metaphysis at a fixed-angle. These wrist and shoulder plates cover an increased area of the bone and provide increased support to the screws extending into the metaphysis. 
         [0007]    Although conventional wrist and shoulder plates have a relatively high and bulky profile that is likely to protrude from the bone of the metaphysis, such protrusion is not a problem because muscles and other soft-tissue overlying the shoulder and wrist acts as a buffer between the plate and soft tissue, which significantly decreases the likelihood of tendon and other soft-tissue irritation. 
         [0008]    Because the hand does not have the similar muscle mass to act as a buffer similar to the shoulder and forearm muscles, the body of conventional hand plates are designed to be much lower in profile. However, the low profile plating systems available must extend on to the metaphysis of tubular bones of the hand when used to stabilize fractures that extend into the metaphysis or into the nearby articular surface. 
         [0009]    Following the fixation of such fractures using conventional hand plating systems, there may be cases in which the plate is prominent, causing tendon and soft-tissue irritation and pain. It is not uncommon, in such cases, for there to be a need for subsequent hardware removal once the fracture has healed, necessitating another surgery. Consequently, conventional hand plates are less than optimal for use in the treatment of certain types of hand fractures. 
         [0010]    Accordingly, it would be beneficial to provide a fracture fixation plate system to stabilize a fracture of a tubular bone in a region having generally low muscle mass, such as the hand, that extends onto the metaphysis of the bone, but is not prominent, avoids soft-tissue irritation, and may be employed via minimally invasive means. 
       SUMMARY OF THE INVENTION 
       [0011]    The present general inventive concept provides a fixed-angled fracture fixation device to treat tubular hand bone fractures that extends onto the metaphysis or articular surface of the tubular hand bone. 
         [0012]    The present general inventive concept also provides a fixed-angled fracture fixation device for rigid osteosynthesis. 
         [0013]    The present general inventive concept also provides a fixed-angled fracture fixation device having a body that does not, itself, extend onto the metaphysis but has locking holes that receive fixed angled screws such that the screws are directed and extend into the metaphysis to facilitate fixation of those tubular hand bone fractures that extend into the metaphysis or articular surface. 
         [0014]    The present general inventive concept also provides a fixed-angled fracture fixation device having a low profile that remains proximal or distal to a metaphysis of a tubular hand bone, thereby avoiding prominence and soft-tissue and/or tendon irritation. 
         [0015]    The present general inventive concept also provides a fixed-angled fracture fixation device having a low profile that is less likely to require removal due to skin irritation and/or tendon ruptures. 
         [0016]    The present general inventive concept also provides a fracture fixation plate that is designed to engage a tubular hand bone, and is not rough to touch. 
         [0017]    The present general inventive concept also provides a fracture fixation plate that is subcondylar such that the fracture fixation plate is situated just below or above the condyle or metaphysis of a tubular hand bone. 
         [0018]    The present general inventive concept also provides a fracture fixation plate that primarily resides on a diaphysis of a tubular hand bone. 
         [0019]    The present general inventive concept also provides a fracture fixation plate for a metacarpal or phalanx. 
         [0020]    The present general inventive concept also provides a fracture fixation plate having a fixed-angled locking feature. 
         [0021]    The present general inventive concept also provides a fracture fixation plate having screws that extend into a metaphysis central portion of a tubular hand bone. 
         [0022]    The present general inventive concept also provides a fracture fixation plate that may be placed in a minimally invasive fashion, e.g., requires only a small incision. 
         [0023]    The present general inventive concept also provides a fracture fixation plate that is substantially rigid and manufactured from stainless steel, titanium alloy, or the like. 
         [0024]    The present general inventive concept also provides a fracture fixation plate that provides proper alignment and stabilization of a tubular hand bone fracture. 
         [0025]    The present general inventive concept also provides at least two fracture fixation plates of different sizes and/or shapes that cooperate to provide a fracture-fixation system for providing proper alignment and stabilization of tubular hand bone fractures. 
         [0026]    The present general inventive concept also provides such an apparatus that is easy to use, comparatively simple to manufacture, and especially well adapted for the intended usage thereof. 
         [0027]    Additional aspects and utilities of the present general inventive concept will be set forth in part in the description that follows and, in part, will be obvious from the description, or may be learned by practice of the general inventive concept. 
         [0028]    The foregoing and/or other aspects and utilities of the present general inventive concept may be achieved by providing. 
         [0029]    The foregoing and/or other aspects and utilities of the present general inventive concept may also be achieved by providing a tubular hand bone fracture fixation apparatus for use with a plurality of screws, the apparatus including an elongated body defining a longitudinal axis, the elongated body having a first portion and a second portion with an upper surface and a bone-engagement lower surface, a first set of apertures through the first portion to orient a number of the plurality of fixation screws along two or more axes, a second set of apertures through the second portion to orient a number of the plurality of fixation screws along a common axis, and an oblong aperture located within the second set of apertures to orient a set screw, wherein the first portion includes a support-enhancement element. 
         [0030]    The apparatus may include a plurality of peaks along the upper surface between the second set of apertures. 
         [0031]    A length of the plurality of peaks may successively increase from the second portion to the first portion. 
         [0032]    The apparatus may include sidewalls of the elongated body extending along the longitudinal axis, wherein the sidewalls extend substantially parallel to each other along the second portion of the elongated body, and the sidewalls diverge along the first portion of the elongated body. 
         [0033]    The apparatus may include a plurality of inward portions of the sidewalls that narrow the elongated body, and a plurality of outward portions of the sidewalls that widen the elongated body. 
         [0034]    Each of the plurality of inward portions may be adjacent to a non-aperture area of the elongated body, and each of the plurality of outward portions may be adjacent to one of the second set of apertures. 
         [0035]    A length of the plurality of outward portions may successively increase from the second portion to the first portion. 
         [0036]    The first set of apertures may be conical tapered inward and angled with respect to a central axis of each of the apertures. 
         [0037]    The support-enhancement element may have an interior with an upper wall and three walls that depend from the upper wall. 
         [0038]    The support-enhancement element may be formed by parallel side surfaces of the elongated body that diverge outward from each other. 
         [0039]    The support-enhancement element may be a buttress, a buttress cavity, or a buttress concavity. 
         [0040]    The bone-engagement lower surface may flare upward and/or outward at the support-enhancement element to form a concavity that may extend onto a metaphyse of a tubular bone. 
         [0041]    The screws may include a fixation screw and/or a set screw. 
         [0042]    The upper surface and the bone-engagement lower surface of the elongated body may extend substantially parallel to each other along the second portion, and/or the upper surface may extend at an upward angle of approximately 13 degrees from the bone-engagement lower surface along the first portion. 
         [0043]    The apparatus may include an elongated aperture extending axially in a direction substantially aligned with the longitudinal axis. 
         [0044]    The elongated body may taper in thickness from the second portion to the first portion and may be thinnest proximate to an edge of the support-enhancement element. 
         [0045]    Each of the first set of apertures and/or the second set of apertures may be conically tapered inward toward the bone-engagement lower surface of the elongated body. 
         [0046]    The apparatus may be a metacarpal plate and/or phalanx plate and may be reversible along a metacarpal and/or phalanx. 
         [0047]    The first set of apertures may include a lower first aperture that may be on the common axis of the second set of apertures, and/or upper second and third apertures that may be opposite to each other on either side of the first aperture on another axis that is perpendicular to the common axis. 
         [0048]    The first set of apertures may orient one or more screws at an angle between 10 and 45 degrees relative to the planar top surface and along a z-axis thereof. 
         [0049]    The elongated body may have a thickness of 1.6 mm, 2.0 mm, or 2.4 mm. 
         [0050]    If only one of a first end or second end is a tapered surface, then a surface opposite to the tapered surface may be a planar surface along the entire length of the plate. 
         [0051]    A first end surface may taper in thickness along one or both of the upper surface and the bone-engagement lower surface. 
         [0052]    One or more of the second set of apertures may have a first diameter and a second diameter, the second diameter being different than the first diameter. 
         [0053]    The second set of apertures may orient one or more of the plurality of fixation screws at an angle between 10 and 45 degrees relative to the planar top surface. 
         [0054]    The screws are headless, locking, not locking, cannulated, not cannulated, or have threaded heads. 
         [0055]    The screws may have a core diameter of 2.0 mm or 2.4 mm. 
         [0056]    The first set of apertures and the second set of apertures may be predrilled locking holes to prevent inadvertent removal or toggling of the screws. 
         [0057]    The apparatus may mount on a bone on a prominent area of the body such as a tubular hand bone such as a metacarpal and/or a phalanx. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0058]    These and/or other aspects and utilities of the present general inventive concept will become apparent and more readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which: 
           [0059]      FIG. 1  is a top plan view of a fracture fixation plate system of the present general inventive concept illustrating a plurality of plates each resident on a tubular hand bone. 
           [0060]      FIG. 2  is a side elevation view of a fracture fixation plate system of the present general inventive concept illustrating a plurality of fracture fixation plates each having a longitudinal planar surface, the fracture fixation plates attached to a metacarpal bone and a phalanx, each fracture fixation plate attached via a plurality of locking screws that extend into the hand bone at an angle that is perpendicular to the plate planar surface and three locking screws on the angled portion of the plate that is at an angle of approximately 12 degrees to the plate planar surface, the screw being fixed at angles of approximately 10-45 degrees to the plate planar surface. 
           [0061]      FIG. 3  is a top plan view of a large fracture fixation plate of the present general inventive concept illustrating tapered or conical apertures and an oblong positioning hole that is non-locking. 
           [0062]      FIG. 4  is a side elevation view of the large fracture fixation plate of the present general inventive concept illustrating a raised first end. 
           [0063]      FIG. 5  is a bottom plan view of the large fracture fixation plate of the present general inventive concept. 
           [0064]      FIG. 6  is a front elevation view of the large fracture fixation plate of the present general inventive concept illustrating the raised first end. 
           [0065]      FIG. 7  is a rear elevation view of the large fracture fixation plate of the present general inventive concept illustrating a body with the first end rising above the body in the background. 
           [0066]      FIG. 8  is a top plan view of a small fracture fixation plate of the present general inventive concept illustrating tapered or conical apertures. 
           [0067]      FIG. 9  is a side elevation view of the small fracture fixation plate of the present general inventive concept illustrating a raised first end. 
           [0068]      FIG. 10  is a bottom plan view of the small fracture fixation plate of the present general inventive concept. 
           [0069]      FIG. 11  is a front elevation view of the small fracture fixation plate of the present general inventive concept illustrating the raised first end. 
           [0070]      FIG. 12  is a rear elevation view of the small fracture fixation plate of the present general inventive concept illustrating a body with the first end rising above the body in the background. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0071]    Reference will now be made in detail to the embodiments of the present general inventive concept, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the like elements throughout. The embodiments are described below in order to explain the present general inventive concept be referring to the figures. 
         [0072]    Referring to  FIGS. 1 and 2 , the present general inventive concept provides a fracture fixation fixed-angled locking plate  1  made of stainless steel or titanium alloy. The plate  1  is placed against and fixed to a shaft or diaphysis of a bone such as tubular bones of the hand including, but not limited to the bones of the fingers, e.g., metacarpal bones and/or phalanges. 
         [0073]    The plate  1  has a body  10  that extends along a longitudinal axis. The plate  1  has a first portion  30  of the body  10  and a second portion  60  of the body  10  on either end of the plate  1 , as illustrated in  FIG. 3 . The body  10  has two sidewalls  12  and  14  that extend the longitudinal axis of the body  10 . The body  10  also has an upper surface  16  and a lower bone-engaging surface  18  that extend the longitudinal axis of the body  10 . 
         [0074]    As the sidewalls  12  and  14  extend along the second portion  60 , the sidewalls  12  and  14  are parallel to each other or at least substantially parallel to each other. As the sidewalls  12  and  14  extend along the first portion  30 , the sidewalls  12  and  14  diverge from each other, i.e., flare out or extend outwardly to form a buttress  40 . The sidewalls  12  and  14  begin to diverge at or adjacent to the point where the first portion  30  and second portion  30  meet. 
         [0075]    As the upper and lower surfaces  16  and  18  extend along the second portion  60 , the upper and lower surfaces  16  and  18  are parallel to each other or at least substantially parallel to each other. As the upper and lower surfaces  16  and  18  extend along the first portion  30 , the upper surface  16  diverges away from the lower surface  18 , the lower surface extending along both the first and second portions  30  and  60  in the same plane. The upper and lower surfaces  16  and  18  begin to diverge at or adjacent to the point where the first portion  30  and second portion  30  meet. 
         [0076]    As illustrated in  FIGS. 4 ,  6 , and  7 , the buttress  40  extends at an upward angle of approximately 12 degrees from the longitudinal axis of the body  10 , and outward via both sidewalls  12  and  14  with respect to the second portion  60 , the second portion  60  having a substantially uniform shape. The buttress  40  has a thickness that is thinner than the other part of the body  10  and may taper to a lesser thickness moving away from the second portion  60 , as illustrated in  FIG. 6 . The buttress  40  at least partially extends onto or fits over a metaphysis of a bone such that the metaphysis is partially engulfed by the buttress  40 . In this manner, the plate  1  is anchored against the metaphysis causing the plate  1  to be better secured to the bone. 
         [0077]    The plate  1  has a plurality of apertures including a first set of apertures  32 ,  33 , and  34  and a second set of apertures  50  to provide a variety of mounting orientations for the plate  1 , thereby providing increased mounting versatility of the plate  1 . The apertures  32 ,  33 ,  34 , and  50  are conical or tapered inwardly toward the bone-engaging surface  18  of the plate  1 . The screws to be accommodated by the apertures  32 ,  33 ,  34 , and  50  may have a screw head with a tapered shape that substantially corresponds to and matches the tapered shape of the apertures  32 ,  33 ,  34 , and  50 . 
         [0078]    The first set of apertures  32 ,  33 , and  34  extend through the first portion  30 , as illustrated in  FIG. 3 . The exemplary embodiment includes three apertures  32 ,  33 , and  34 . It is foreseen, however, that only two or one apertures may be employed in the first portion  30 . 
         [0079]    Aperture  32  is centered on the longitudinal axis of the body  10 . Apertures  33  and  34  are centered on an axis that is perpendicular to the longitudinal axis of the body  10 , and are offset on either side of aperture  32 . The conical shape of the apertures  32 ,  33 , and  34  vary to enable the apertures  32 ,  33 , and  34  to receive and direct set screws  70  at different angles, such as angles of 10-45 degrees and preferably 15-45 degrees, relative to a plane defined by the upper surface  16 . 
         [0080]    The pegs or set screws  70  are preferably angled by the apertures  32 ,  33 , and  34  in more than one direction, e.g., in two dimensions, to reflect the bone size increase from the diaphysis to the metaphysis. This permits penetration by the set screws  70  into an area of the bone that is more expansive than an area covered by the plate  1 , i.e., into an area greater than a width of the plate  1  and/or beyond an edge  12  or  14  of the plate  1 , as depicted in  FIG. 2 . 
         [0081]    The second set of apertures  50  extend through and along the second portion  60 , as illustrated in  FIG. 3 . The exemplary embodiment includes six apertures  50 . It is foreseen, however, that more or fewer apertures may be employed in the second portion  60 . 
         [0082]    The apertures  50  extend in a line along the longitudinal axis of the body  10  and are of equal size and shape such that pegs or set screws  80  inserted therein are directed into the bone at angles that are equal to each other. While the majority of apertures  50  are equidistant from each other, one of the apertures  50  is separated from the other apertures  50  by an oblong aperture  55  to provide tolerance for movement of the plate  1  after initial placement of the plate  1  on the bone. 
         [0083]    The oblong aperture  55  is designed to accept a first of the set screws  80  to affix the plate  1  to the bone such that as the first of the set screws  80  penetrates the bone, the plate  1  becomes rigidly clamped to the bone. Specifically, the first of the set screws  80  is initially installed through an approximate center of the oblong aperture  55  to secure the plate  1  to the shaft of the bone. If it is determined that the plate  1  is not in an ideal position and repositioning of the plate  1  is desired, the first of the set screws  80  can be loosened from the oblong aperture  55  to permit the plate  1  to be slid along a length of the oblong aperture  55  with respect to the first of the set screws  80  and without completely removing the first of the set screws  80  from the bone. If the first of the set screws  80  is initially installed near the center of the oblong aperture  55 , the plate  1  may be slid in either direction relative to the first of the set screws  80  with respect to the oblong aperture  55 . 
         [0084]    When the plate  1  is in an ideal position, one or all of the set screws  70  are then installed through the fixed-angled locking apertures  32 ,  33 , and  34 , which direct the set screws  70  into the metaphysis of the bone. Any of the apertures  32 ,  33 , and  34  can initially be used to hold the fracture reduced (by inserting a guide wire through it) while the other aperture(s) are drilled and filled with the appropriate length screw to stabilize the fracture. After the set screws  70  are installed, the set screws  80  are installed through the fixed-angled locking apertures  50 , which direct the set screws  80  into the shaft of the bone. 
         [0085]    The sidewalls  12  and  14  are waved running along a substantially S-shaped path extending inward and outward opposite to each other along the longitudinal axis of the body  10 . The sidewalls  12  and  14  have inwardly-extending portions  65  that extend inwardly when the sidewalls  12  and  14  are adjacent to areas of the second portion  60  between the apertures  50 . The sidewalls  12  and  14  have outwardly-extending portions  66  that extend outwardly when the sidewalls  12  and  14  are adjacent to apertures  50 . The inwardly-extending portions  65  and outwardly-extending portions  66  extend inward and outward along the longitudinal axis at the same distance along the entire length of the second portion  60 . The lengths of the outwardly-extending portions  66  increase as the sidewalls  12  and  14  extend from the second portion  60  to the first portion  30  along the longitudinal axis of the body  10 . 
         [0086]    For instance, the outwardly-extending portions  67  adjacent to the oblong aperture  55  is longer along the longitudinal axis of the body  10  relative to the outwardly-extending portions  66  on a side of the oblong aperture  55  opposite to the first portion  30 . Likewise, the outwardly-extending portion  68  adjacent to the meeting point of the first portion  30  and the second portion  60  is longer than the outwardly-extending portion  67 . The inwardly-extending portions  65  and outwardly-extending portions  66  permit the plate  1  to be as thin as possible while maintaining structural integrity. 
         [0087]    The upper wall  16  is waved running along a substantially S-shaped path extending inward and outward along the longitudinal axis of the body  10 . The upper wall  16  has inwardly-extending portions  73  that extend inwardly toward the lower bone-engaging surface  18  when the upper wall  16  is adjacent to apertures  50 . The upper wall  16  has outwardly-extending portions or peaks  72  that extend outwardly when the upper wall  16  is adjacent to areas of the second portion  60  between the apertures  50 . The inwardly-extending portions  73  and outwardly-extending portions  72  extend inward and outward along the longitudinal axis at the same distance along the entire length of the second portion  60 . The lengths of the outwardly-extending portions  72  increase as the upper wall  16  extends from the second portion  60  to the first portion  30  along the longitudinal axis of the body  10 . 
         [0088]    For instance, at the meeting point between the first portion  30  and second portion  60 , an outwardly-extending portion  74  is formed that has a length greater than the outwardly-extending portions  72  along the longitudinal axis of the body  10  on a side of the oblong aperture  55  opposite to the first portion  30 . Likewise, the outwardly-extending portion  75  between the apertures  34  and  35  has a length greater than the outwardly-extending portion  74 . The inwardly-extending portions  73  and outwardly-extending portions  72  permit the plate  1  to be as thin as possible while maintaining structural integrity. 
         [0089]    The plate  1  may have a thickness of 2.0 mm and 2.4 mm.  FIGS. 3-7  illustrate plate  1 , which is 2.4 mm.  FIGS. 8-12  illustrate a plate  100  that is substantially identical to plate  1  except it is 2.0 mm. Plate  100  accommodates the set screws  70  and  80  of plate  1 . It is foreseen, however, that other plates may be made smaller, e.g., with a thickness of 1.4 mm and 1.6 mm, and still accommodate set screws  70  and  80  of plate  1  or may be made smaller and only accommodate set screws or pegs that are smaller than set screws  70  and  80 . 
         [0090]    To accommodate the set screws  70  and  80  of plate  1  in relatively smaller plate  100 , sidewalls  112  and  114  of body  110  are closer to apertures  150 , as illustrated in  FIG. 8 . To maintain sufficient structural integrity of the plate  100 , there is a smaller angle of expansion of sidewalls  112  and  114  as the body  110  forms a buttress  140 . The smaller angle of expansion results in a thicker neck portion of the buttress  140  between aperture  132  and an adjacent aperture of apertures  150 . 
         [0091]    It is foreseen that the plate  1  may be placed such that the buttress  40  is adjacent to an upper or lower condyle of a metacarpal. Likewise, it is foreseen that the plate  100  may be placed such that the buttress  140  is adjacent to an upper or lower condyle of a phalanx. In this manner, the plates  1  and/or  100  may be placed in either a forward or backward direction, as illustrated in  FIGS. 1 and 2 . 
         [0092]    The set screws  70  and  80  may be locking and/or non-locking and may have a screw head and/or be headless, locking and/or non-locking, fully threaded and/or lag (partially threaded) and/or cannulated. The 2.0 mm and 2.4 mm screws may be cannulated with a passage through an interior length thereof to accommodate a pre-inserted guide wire or the like. 
         [0093]    While the present general inventive concept is intended for tubular bones of the hand, it is foreseen that the present general inventive concept may be employed to stabilize fractures of small bones other than tubular hand bones, such as but not limited to the tip of the elbow or the lateral side of the ankle. 
         [0094]    Although a few embodiments of the present general inventive concept have been illustrated and described, it will be appreciated by those skilled in the art that changes may be made in these exemplary embodiments without departing from the principles and spirit of the general inventive concept, the scope of which is defined in the appended claims and their equivalents.