Patent Document

FIELD OF THE INVENTION  
       [0001]     The present invention relates to external orthopedic fixation devices and, more particularly, pertains to an external orthopedic bone and/or joint fixation component, such as for the foot and/or ankle.  
       BACKGROUND OF THE INVENTION  
       [0002]     In the orthopedic reconstruction of a patient&#39;s bone and/or joint, particularly with respect to bone repair thereof, it is necessary to keep the repaired bone and/or joint in an immobilized and stable state during the healing process. This is accomplished by using a frame construct that typically includes many different fixation components. The various fixation components are utilized to build a fixation device for immobilizing the bone and/or joint. One such fixation component may be an immobilization platform or platform construct.  
         [0003]     In the area of the foot and/or ankle, what is known as a foot frame is generally utilized. Current foot frames are typically of an open U-ring type. The open U-rings may comprise a single “horseshoe-shaped” frame or may include myriad pieces that must be assembled during and for use (known as a modular foot frame).  
         [0004]     During the particular surgery, one or more wires, pins, or half pins as they are known in the art are implanted through particular bones of the bone/joint (e.g. the foot and/or ankle). These wires, olive wires, pins, or half pins (collectively, wires) are utilized to immobilize and/or apply compression to the particular and/or surrounding bones in order to create a proper healing environment. The wires themselves need to be externally fixed in order to create a desired compression result on the bone or bones and/or joint or joints. This is currently accomplished by tying the wires to wire/rod nuts on the various components of the open U-ring foot frame. These systems, however, suffer problems with respect to being able to achieve the desired compression results, e.g. the ability to adequately externally fix the wires and provide controlled compression. This can lead to instability problems. Moreover, it is difficult to achieve accurate in-plane compression with current fixation devices.  
         [0005]     In order to resolve these problems, the prior art bends the transverse wires from the ankle/foot, then tensions the bent wires to achieve compression. This is known as walking the wires. The bent and tensioned wires are then attached to the open U-frame. Tensioning bent wires, however, does not provide a controlled or measurable amount of compression on the desired area of the ankle/foot.  
         [0006]     With respect to after surgery and particularly with respect to the foot and/or ankle, the surgical area (ankle/foot area) is exposed. It is thus necessary in some respects to protect the particular area (ankle/foot). Prior art fixation devices utilize an additional ring positioned inferior to the foot frame to protect the bottom of the foot. This technique is time consuming and costly.  
         [0007]     In view of the above, there is a need for an external bone and/or joint fixation device that provides improved fixation.  
         [0008]     In view of the above, there is a need for an improved external bone and/or fixation device that may be used as part of a larger fixation system.  
         [0009]     In view of the above, there is a need for an external foot and/or ankle fixation device that provides improved fixation.  
         [0010]     In view of the above, there is a need for an external foot and/or ankle fixation device that provides for greater fixation stability.  
         [0011]     In view of the above, there is a need for an external foot and/or ankle fixation device that provides for improved controllable compression.  
         [0012]     In view of the above, there is a need for an external foot and/or ankle fixation device that provides accurate in-plane compression.  
         [0013]     In view of the above, there is a need for an external foot and/or ankle fixation device that can provide various degrees of fixation member angulation in an anterior/posterior direction.  
         [0014]     In view of the above, there is a need for an external foot and/ankle fixation device that includes a dedicated elevator to protect the bottom of the foot from contaminates while still providing access for wound care.  
         [0015]     In view of the above, there is a need for an external foot/ankle fixation device that allows adjustable, controlled anterior/posterior compression for medial/lateral fixation members.  
       SUMMARY OF THE INVENTION  
       [0016]     In a general form, the subject invention is an external bone and/or joint fixation device. The fixation device allows the attachment of various anterior/posterior and/or medial/lateral fixation wires or members for immobilizing the bone and/or joint. Such attachment may be made at various angles in the general anterior/posterior direction. Moreover, the fixation device allows controlled compression along various medial/lateral and/or anterior/posterior directions. The fixation device may be used as one construct in a fixation system.  
         [0017]     In a specific form, the present invention is an external foot/ankle fixation device. The fixation device has a preferably, but not necessarily, one-piece frame component and a positionable cross bar that allows the attachment of generally anterior/posterior directed fixation wires (e.g. olive wires) or rods emanating from the foot/ankle of a patient. The fixation wires may be attached in various angles relative to an anterior/posterior plane. The external fixation device provides a stable fixation platform both in-plane and out-of-plane of the object of fixation (e.g. foot or ankle).  
         [0018]     Through the cross bar, the fixation device also provides various degrees of angulation of anterior/posterior directed fixation wires in two planes. Posterior angulation components may be provided to the posterior portion of the frame component that provides additional fixation wire/rod angulation variations. An optional elevator component may be attached to the bottom of the frame component that does not obstruct access to the soft tissues on the bottom of the foot while still protecting the bottom of the foot from contaminated surfaces.  
         [0019]     The ring frame is constructed as a closed, one-piece platform. This provides a stable platform for object fixation. This approach is simple and less expensive than modular alternatives. The present invention solves the instability problems of current open U-ring foot/ankle fixation devices. Additionally, the bottom of the foot of the patient may also be protected. Moreover, the present invention allows the accurate application of in-plane compression using tension or fixation wires. The present invention also allows the capture of fixation wires tied to various degrees of angulation in a posterior/anterior direction.  
         [0020]     The present external ankle/foot fixation device is also able to provide controlled and/or incremental compression (to the ankle/foot) for certain wires thereof along the anterior/posterior direction. Distraction and/or initial placement of half pins and the like are also achievable. Preferably movable compression rails are situated on the medial/lateral sides of the foot frame. The compression rails move along the anterior/posterior direction. The compression rails or components provide attachment of medial/lateral fixation wires for anterior/posterior compression.  
         [0021]     In one form, there is provided an external bone/joint fixation component. The bone/joint fixation component has a one-piece or modular frame having a posterior portion lying essentially in a first plane and an anterior portion transverse to the posterior portion and lying essentially in a second plane, and a first plurality of fixation bores disposed in the posterior portion and a second plurality of fixation bores disposed in the anterior portion each of which is configured to receive a wire fixator that is adapted to receive an end of a fixation wire.  
         [0022]     In another form, there is provided an external bone/joint fixation device. The external bone/joint fixation device includes a frame and a cross bar. The frame component is defined by a posterior portion and an anterior portion disposed transverse to the posterior portion, and includes a plurality of first fixation bores each of which is configured to receive a wire fixator that is adapted to receive an end of a fixation wire. The cross bar component is attachable to the anterior portion of the frame component and has a plurality of second fixation bores each of which is configured to receive a wire fixator that is adapted to receive another end of the fixation wire. The cross bar and the frame component providing controlled compression of a bone or joint retained by fixation wires tied to the frame component and the cross bar.  
         [0023]     In yet another form there is provided an external bone/joint fixation device. The bone/joint fixation device includes a frame component and first and second compression rails disposed on the frame component. The frame component is defined by a posterior portion and an anterior transverse portion and includes a plurality of fixation bores. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0024]      FIG. 1  is a perspective view of a frame component of the present external bone/joint fixation device;  
         [0025]      FIG. 2  is a perspective view of a cross-bar component of the present external bone/joint fixation device;  
         [0026]      FIG. 3  is an enlarged perspective view of a cross bar holder of the present external bone/joint fixation device;  
         [0027]      FIG. 4  is an enlarged side view of the cross bar holder of  FIG. 3 ;  
         [0028]      FIG. 5  is an enlarged perspective view of a posterior angulation component of the present external bone/joint fixation device;  
         [0029]      FIG. 6  is an enlarged side view of the posterior angulation component of  FIG. 5 ;  
         [0030]      FIG. 7  is an exploded perspective view of one form of the present external bone/joint fixation device;  
         [0031]      FIG. 8  is a fragmentary view of a portion of the posterior section of the frame component with two posterior angulation components attached thereto;  
         [0032]      FIG. 9  is an anterior to posterior view of an exemplary configuration of a fixation device in accordance with an aspect of the principles of the subject invention;  
         [0033]      FIG. 10  is a side view of the present fixation device showing exemplary placement of tension rods, wires, half pins or the like without depicting a foot;  
         [0034]      FIG. 11  is a perspective view of an exemplary external bone/joint fixation device having an exemplary foot elevator in accordance with an aspect of the principles of the subject invention;  
         [0035]      FIG. 12  is an enlarged fragmentary view of one leg of the anterior frame section of the fixation device showing an alternative embodiment to discrete cross bar angulation bores, particularly showing a continuous cross bar angulation slot;  
         [0036]      FIG. 13  is a top perspective view of a bone/joint frame in accordance with the principles of the subject invention having an embodiment of positionable compression rails;  
         [0037]      FIG. 14  is an enlarged perspective view of one of the compression rails of  FIG. 13 ;  
         [0038]      FIG. 15  is a side perspective view of the fixation frame construct of  FIG. 13  with medial/lateral fixation wires superimposed thereon;  
         [0039]      FIG. 16  is rear, side perspective view of a bone/joint frame in accordance with the principles of the subject invention having an alternative embodiment of positionable compression rails;  
         [0040]      FIG. 17  is an enlarged perspective view of one of the compression rails of  FIG. 16 ;  
         [0041]      FIG. 18  is a side perspective view of the fixation frame construct of  FIG. 16  with medial/lateral fixation wires superimposed thereon;  
         [0042]      FIG. 19  is a top plan view of an exemplary alternative embodiment of an external bone/joint frame having an exemplary alternative embodiment of compression rails in accordance with an aspect of the principles of the subject invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0043]     While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the invention to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the invention as defined by the appended claims.  
         [0044]     Referring now to  FIG. 1 , there is depicted an exemplary embodiment of a frame component (frame), generally designated  20 , of a bone/joint fixation device configured in accordance with the principles of the subject invention. While the present bone/joint fixation device or component is shown and described with respect to a foot/ankle device or component, it should be appreciated that the principles and/or the particular embodiments of the present foot/ankle fixation device/component are applicable to bones and/or joints. Moreover, while the present bone/joint fixation device may be utilized as a stand alone device or component, such a bone/joint fixation device is typically utilized in conjunction with other fixation components to create a fixation system.  
         [0045]     A body  22  defines the frame component  20  that may take various shapes and be constructed from various angled and non-angled pieces while formed in accordance with the principles presented herein. Thus, while a particular frame shape is shown, it should be appreciated that other frame shapes are contemplated and may fall within the principles of the subject invention. Particularly, the body is defined in first and second planes. The first and second planes are approximately (within an angle), but not necessarily, transverse. The body  22  is configured to surround a bone and/or joint area.  
         [0046]     The frame is preferably formed of a unitary piece (i.e. one piece), but may be modular (i.e. more than one piece). The term body (and frame) thus refers to both configurations. The body  22  may be fashioned from a composite material such as carbon fiber, metal, metal alloy, polymer, shape memory polymer, shape memory metals, or other suitable material that provides an adequate stiffness or resistance to torsion, stress, torque and/or other forces that may be applied to the body  22 . The material is also preferably, but not necessarily, radiolucent.  
         [0047]     The body  22  is generally configured to capture the posterior aspect of a foot and thus may take various shapes. In the embodiment shown, the body  22  is generally formed in the shape of a “U”, heel or the like. This may be generally characterized as oblong, oval or ovoid. In the modular case, the body  22  may be formed of variously curved and/or straight pieces. The body  22  has a posterior frame section  26  extending from two side frame sections  24  and  25 . The three frame sections  24 ,  25  and  26  define a geometric plane R. An anterior frame section  28  is disposed at an anterior portion of the frame body  22 , particularly extending from other ends of the side frame sections  24  and  25 . The anterior frame section  28  is situated in a generally vertical direction relative to the plane R. While not necessary, the anterior frame section  28  is preferably perpendicular to the plane R and thus the posterior frame section  26  and the two side frame sections  24 ,  25 . The anterior frame section  28  may be angled from the perpendicular in both directions.  
         [0048]     A plurality of holes, bores, apertures or the like  30  is disposed along the body  22 . The holes  30  extend along a posterior portion of the frame body  22  toward the anterior portion (vertical section  28 ) of the frame body  22 . The plurality of holes may be situated anywhere. As such, the plurality of holes  30  may be formed as one or more rows of holes, sets of holes, various pairs of holes (e.g. diametrically opposed pairs of holes), or other configurations or holes. While the holes  30  are depicted in  FIG. 1  as formed in essentially two rows extending along the two side portions and the posterior portion of the frame, it should be appreciated that it is not necessary for the holes  30  to be in any particular pattern or formation. It is advantageous to locate the holes  30  in strategic positions with regard to typical foot/ankle fixation members and/or techniques. The holes  30  may be disposed in pre-determined patterns based on typical foot/ankle anatomy. Certain frames may be provided with holes in only particular strategic locations that correspond to typical fixation configurations and/or techniques. A pattern such as that shown, though, allows precise alignment and anchoring of tension wires from and relative to the frame by the physician for foot/ankle fixation. Each bore  30  is adapted, configured and/or operative to receive and retain a wire nut or the like (not shown in  FIG. 1 ) that is designed to releasably retain a portion (such as an end) of a fixation member such as a tension wire, olive wire or the like.  
         [0049]     A first plurality of bores  34  forming a first series or set of bores is disposed on a leg or leg portion  35  of the anterior frame section  28 . A second plurality of bores  36  forming a second series or set of bores is disposed on another leg or leg portion  37  of the anterior frame section  28 . The first and second set of bores  34 ,  36  are adapted, configured and/or operative to allow a bolt or other fastening device to extend therethrough. Each set of bores  34  and  36  permits the fastening of a cross bar holder such as the cross-bar holder  40  particularly shown in  FIGS. 3 and 4 .  
         [0050]     Each cross-bar holder  60  is held against a leg  35 ,  37  of the anterior frame member  28  through a single respective bore  34 ,  36 . While explained in greater detail below, a cross-bar holder  60  may be positioned in and held by any one bore of a respective set of bores  34 ,  36 . Particularly, a cross-bar holder  60  may be positioned in any one bore of the bores of the set of bores  34 , while another cross-bar holder  60  may be positioned in any one bore of the set of bores  36 . This allows for each cross-bar holder  60  to be in corresponding bore of the two sets of bores  34 ,  36 . This also allows for each cross-bar holder  60  to be in different (non-corresponding) bore of each set of bores  34 ,  36 . When the cross-bar holders are in corresponding bores  34 ,  36 , the cross bar  40  is generally coplanar with the plane R. When the cross-bar holders are in non-corresponding bores  34 ,  36 , the cross bar  40  is at an angle with respect to the plane R (i.e. angulation). This allows tension wires to be situated in various angulations with respect to the plane R (and thus the foot/ankle).  
         [0051]     The bores  34 ,  36  are preferably ovoid or elliptical in shape. This allows a range of adjustment for a bolt received in a bore when the cross-bar holders are situated in non-corresponding bores  34 ,  36 . Moreover, this accommodates the translation of the bolt when the cross bar  40  is in a diagonal state. This result may be achieved by other means. Referring to  FIG. 12 , there is depicted a leg  35   a  of an anterior frame section  28   a  of an exemplary alternative embodiment of an ankle/foot fixation frame  20   a . Rather than discrete bores, the leg  35   a  has a slot or channel  180 . This provides continuous cross bar adjustment and diagonal placement accommodation. The slot  180  may be configured in other manners.  
         [0052]     The anterior frame section  28  includes a plurality of bores  32  forming a third series or set of bores. Each bore  32  is adapted, configured and/or operative to receive and retain a fixation post or the like (not shown in  FIG. 1 ) that is designed to releasably retain a portion (such as an end) of a tension wire. The body  22  of the frame component  20  may also include demarcation or tensioning marks shown in  FIG. 1  as numbers  9 - 12  and  1 - 3 . These correspond to general clock nomenclature. Other types of calibration marking may be used. The calibration markings may correspond to like markings on other components in order to provide alignment of fixation rods.  
         [0053]     The anterior frame section  28  is not necessarily perpendicular to the sides  24 ,  25 . The legs  35  and  37  of the anterior frame section  28  may be angled anywhere from 70°-120° from the perpendicular. Preferably, such an angle is from 80°-110° and is most preferably 90° (perpendicular).  
         [0054]     It should be appreciated that the frame component  20  may be made in various sizes, such as small, medium and large, both with respect to the frame itself and particularly to the inner area of the frame (i.e. the area surrounded by or within the frame). This may also be the area between the two legs of the body  22  as depicted in the embodiment of  FIG. 1 .  
         [0055]     The size (area) may range from 130 mm to 220 mm and preferably from 150 mm to 190 mm. The body  22  has an inner arcuate edge  38  that bounds and thus defines an inner area. The inner area is where the foot and/or ankle of a patient is generally retained typically through fixation members that extend into and out of a foot and/or ankle of a patient (not shown) in locations best determined by a physician. By having frame sections (side sections  24 ,  25 , posterior section  26 , and anterior section  28 ) of different dimensions, the frame component  20  may accommodate feet of various dimensions. The frame component  20  may also be made with posterior sections  26  and/or anterior sections  28  of different rates of curvature. Various configurations including modification of the ovoid shape of the frame component  20  may also be made in accordance with an aspect of the principles of the subject invention and is contemplated. Moreover, a set of frames of various dimensions may be provided. The thickness of the frame may range from 0.06 to 0.5 inches and is preferably 0.25 inches.  
         [0056]     Referring now to  FIG. 2 , there is depicted an exemplary embodiment of an anterior angulation member generally designated  40  made in accordance with an aspect of the principles of the subject invention. The angulation member  40  is embodied in  FIG. 2  as a cross bar. The cross bar  40  is configured to receive and retain fixation posts for retention of tension members such as tension wires. Moreover, the cross bar  40  is adapted to be attached to the frame component  20  as described below. The cross bar  40  is preferably fabricated from a metal, metal alloy, composite, polymer, shape memory polymer, memory shape metal, or similar material that can provide an appropriate stiffness and/or be radiolucent.  
         [0057]     The cross bar  40  is defined by a body  42  that, in this embodiment, has a tubular or cylindrical shaped section  44 . Of course, other body shapes are contemplated. A neck  46  axially extends from one end  48  of the body section  44 . The neck  46  is operative, configured and/or adapted to allow operative attachment of the end  48  (a portion of) the body section  44  to the frame component  20 . As well, the neck  46  may be fashioned in other configurations. An O-ring groove  47  is disposed in the surface of the neck  46 . A neck  50  extends from another axial end  52  of the body section  44 . The neck  50  is operative, configured and/or adapted to allow operative attachment of the end  52  (a portion of) of the body section  44  to the frame component  20 . The neck  50  may be fashioned in other configurations. An O-ring groove  51  is disposed in the surface of the neck  50 .  
         [0058]     The body  42  includes a plurality of bores  56  each one of which preferably, but not necessarily, extend through the body section  44 . The openings of each bore  56  is defined in a recess, trough, channel or the like  54  (an opposite recess of which cannot be seen in  FIG. 2 ). The recess  56  is sized to have fixation posts, wire nuts or the like that are disposed thereon maintain a low profile and/or be below the surface of the recess  56 . The cross bar  40  is configured to be immovably, but releasably, fixed in a particular angular orientation and/or in a particular rotational orientation relative to the anterior of the frame component  20 .  
         [0059]     Referring now to  FIG. 3 , there is depicted an enlarged perspective view of an exemplary cross bar holder or clamp generally designated  60 . The cross bar holder  60  is utilized to releasably retain one end of the cross bar  40  and to be releasably fastened or mounted to the frame component  20 . Because of its clamping function, the cross bar holder  60  also allows the rotational positioning of the cross bar  40  relative to the frame component  20 . Two cross bar holders  60  retain the cross bar  40  in a fixed anterior position or angle (angulation) and rotationally orientated relative to the frame component  20 .  
         [0060]     The cross bar holder  60  is characterized by a body  62  here shown as a generally slightly elongated block. The body  62  has a bore  64  extending from a face  66  of the body  62  to an opposite face  68 . The bore  64  defines an opening or shaft  65  that is sized to receive, with preferably little clearance, a neck of the body  42  of the cross bar  40 . When the holder  60  is an unclamped state, the opening  65  allows receipt of a neck of the cross bar  40  and the rotation (around a longitudinal axis) of the cross bar  40 . When the holder  60  is in a clamped state, the opening  65  is clamped tightly around the neck preventing rotation and extraction.  
         [0061]     In order to provide the above-mentioned clamping feature, the body  62  has a longitudinal slot, slit, groove, channel or the like  76  that extends through side face  77  to another side face  78  in one direction, and from the end face  68  to a point in the body  62  a distance from the other end face  66 . The slot  76  allows the body  62  to serve as a clamp around a neck of a cross bar  40  that is in the bore  64  when compression is applied to the body  62 . This is best understood with reference to the side view of the cross bar holder  60  depicted in  FIG. 4 . A bolt bore  70  is also disposed in the body  62  extending from the upper surface  72  to the lower surface  74 . The bolt bore  70  is proximate the end face  68 .  
         [0062]     When a bolt or the like is received in the bolt bore  70  and secured with a nut or the like, compression of the body  62  will result. Particularly, compression of a first portion  67  of the body  62 , defined as an upper half of the body  62  by the slot  76 , and a second portion  69  of the body  62 , defined as a lower half of the body  62  by the slot  76 , against one another closes the gap size of the slot  76  resulting in a decreased diameter opening  65 . The amount of compression determines the reduction of diameter size of the opening  65  and thus the tightness of the clamping.  
         [0063]     Referring now to  FIGS. 5 and 6 , there is depicted an exemplary embodiment of a posterior angulation component generally designated  80 . The posterior angulation component  80  is adapted, configured and/or operative to allow the retention of fixation wires and/or rods via fixation posts (not seen in  FIGS. 5 and 6 ). The posterior angulation component  80  is further adapted, configured and/or operative to attach to the posterior portion (end  26 ) of the frame body  22 .  
         [0064]     The posterior angulation component  80  is formed by a body  82  defining a frame attachment portion  84  and a fixation post portion  85 . The frame attachment portion  84  is configured, adapted and/or operative to allow the posterior angulation component  80  to be securely attached to the frame  20  and particularly, to an outer portion of the posterior frame section  26  off the body  22  of the frame component  20  such as is shown in  FIG. 8 .  
         [0065]     The frame attachment portion  84  is characterized by a first section  86  having an upper bar  88  extending generally perpendicular from a first surface  89  of the first section  86 . The upper bar  88  has an overhanging ledge  92  that along with a portion of the first surface  89  defines a channel  94 . The height or thickness of the channel  94  is dimensioned to receive a portion of the frame body  22 , particularly at the posterior portion  26  thereof. The channel  94  is also slightly curved in approximately the same curvature as the posterior portion  26  of the frame body  22 .  
         [0066]     It should be appreciated that the posterior angulation piece  80  may come in different sizes to accommodate different sizes of frames. With respect to the embodiment of  FIG. 1 , the various posterior pieces would have different radius of curvatures in order to be accommodated on frame sizes having different radii of curvature. One posterior piece, however, may accommodate more than one frame size.  
         [0067]     A plurality of holes  96 , here depicted as three holes, are disposed in the first section  86  and extend from an upper surface thereof to a lower surface thereof. The holes  96  are configured to allow mounting bolts or the like to extend therethrough in order to allow the attachment of the body  82  to the frame body  22 . When installed, each hole  96  may accommodate a mounting bolt.  
         [0068]     The fixation post portion  85  of the body  82  includes a lower trough or channel  104  and an upper trough or channel  102  in a rear body portion  100 . A plurality of bores  106  are disposed in the rear body portion  100  providing communication between the upper trough  102  and the lower trough  104 . The bores  106  are configured to receive a wire or rod fixation post of a wire or rod fixation member (see  FIG. 8 ). The lower trough  104  allows the use of a tool to retain, tighten and/or loosen a nut or other fastening device to a wire/rod fixation post. The upper trough  102  allows access to a wire/rod fixation member knob for retaining a wire and/or rod thereto during use. The upper surface  89  and the lower surface  91  are both angled upward relative to a posterior/anterior direction. This allows the attachment of fixation wires to the posterior angulation device  80  and the cross bar  40 . This is best seen in  FIG. 10 .  
         [0069]     As seen in  FIG. 10 , the upper and lower angled surfaces of the posterior angulation device  80  allows the fixation wires  130  and  132  to extend from the posterior angulation device  80 , through the plane of the frame  20 , and be coupled to the cross bar  40 . The configuration allows the fixation wires to go through the frame.  
         [0070]     Referring to  FIG. 7 , there is depicted an exploded view of an exemplary fixation device generally designated  110 . The fixation device  110  is formed by the frame component  22 , a cross bar  40 , two cross bar holders  60 , and a bolt assembly comprising a bolt  114  and nut  116 .  
         [0071]     Particularly, the opening  65  of a cross bar holder  60  receives a neck  46 ,  50  of the cross bar  40  after receipt of an o-ring  112  on the neck. One cross bar holder  60  is attached to one bore of the plurality of bores  34  of the leg  35  via a bolt  114  extending through the selected bore  34  and the bolt bore  70  of the particular cross bar holder  60  and secured by a nut  116 . The other cross bar holder  60  is attached to one bore of the plurality of bores  36  of the leg  37  via another bolt  114  extending through the selected bore  36  and the bolt bore  70  of the particular cross bar holder  60  and secured by a nut  116 . The cross bar  40  provides an anterior positioning/retention device for attachment and retention of one or more fixation or tension wires/rods.  
         [0072]     It should be appreciated that each cross bar holder  60  may be positioned in any one of the plurality of holes  34  on one side, and in any one of the plurality of holes  36  on another side. When each cross bar holder is in the same hole position, the cross bar  40  is generally co-planar with the plane R (which generally corresponds to the sole of a foot). The elevation of the cross bar  40  is dependent upon which set of holes  34 ,  36  the cross bar holders are situated on.  FIG. 7  depicts six (6) co-planar positions of the cross bar  40  each at a different elevation relative to the plane R (i.e. six pairs of holes  34 ,  36 ). Additionally, and as contemplated, the cross bar  40  may be positioned in various angular orientations relative to the plane R by positioned the cross bar holders in non-paired holes  34 ,  36 . Moreover, the cross bar  40  may be rotated about its longitudinal axis before the cross bar holders  60  are tightened.  
         [0073]     Reference is now directed to  FIG. 8  where there is depicted a posterior angulation assembly generally designated  120  as part of a fixation device in accordance with an aspect of the principles of the subject invention. Particularly, the posterior angulations assembly  120  depicts two posterior angulation components  80  attached to the posterior portion  26  of the frame body  22 . The posterior angulation components  80  are each attached via an attachment bolt  122  that each extend through a respective hole  30  in the posterior portion  26  and a respective hole  96  in the respective front portion  86  of the posterior angulation component  80  (see  FIGS. 6 and 7 ).  
         [0074]     One of the posterior angulation components  80  includes two fixators or fixation assemblies  124 . Each fixation assembly  124  is configured, adapted and/or operative to releasably retain a fixation wire or rod. The fixation assemblies  124  include a fixation post  126  and a fixation knob  128 . A fixation post  126  is shown on the other posterior angulation component  80 .  
         [0075]     Each posterior angulation component  80  may be positioned anywhere along the posterior portion  26  of the frame  20  and may have up to three fixation assemblies  124  (corresponding to the three holes). A fixation or tension wire or rod is attached to a fixation assembly  124  at the posterior end to provide in-plane anterior to posterior fixation.  
         [0076]      FIG. 9  depicts an end (anterior) view of the fixation device having the two posterior angulation components  80  attached to the frame component  20 . It should be appreciated that fixation wires may extend from one of the holes  32  via a fixation assembly and extend to either one of the holes  30  in the frame  20  and/or a posterior angulation component  80 . Generally, the wires/rods extend in an anterior/posterior (A/P) direction.  
         [0077]      FIG. 9  also illustrates the ability of the present fixation device to provide various angulations or angular alignments for the A/P relative to the plane R of the frame component  20 . Particularly, the cross bar  40  is able to change its height (H) relative to the plane R (see  FIG. 1 ). This is accomplished by selectively attaching the cross bar holders  60  in appropriate holes  34 ,  36  of the legs  35 ,  37 . Additionally, the cross bar  40  may rotate as indicated by the arrow. Moreover, the cross bar  40  may assume various angles (A) relative to the plane R. This is accomplished by attaching the cross bar holders  60  to non-paired holes  34 ,  36 . The various positions provide angular variance from a coplanar position of the cross bar  40  with the plane R.  
         [0078]     In  FIG. 10 , there is shown a side view of an external fixation device having a fixation wire or rod  130  extending from the cross bar  40  in a posterior/anterior (P/A) or anterior/posterior (A/P) direction. A foot would be positioned with the heel at the posterior portion (P). Other fixation wires/rods would typically be used. The fixation wire  130  is angled from the upper angled surface  89  of the posterior angulation component  80  and terminates at the cross bar  40 .  
         [0079]     Another fixation wire  132  is provided from the underside of the posterior angulation component  80 . Particularly the fixation wire  132  is angled from the lower angled surface  91  of the posterior angulation component  80 . The fixation wire  132  terminates at the cross bar  40 .  
         [0080]      FIG. 11  depicts an elevator, elevator component, elevator frame component generally designated  150  attached to the bottom of the frame component  20 . The elevator  150  is defined by two legs  152  and  154  that correspond to frame portions  24  and  25  and thus run the length thereof. Additionally, the elevator  150  has two front portions  156 ,  158  that support the posterior portion  26  of the frame component  20 . This open concept allows access to the sole of a foot retained therein.  
         [0081]     The elevator  150  also has a first pedestal  160  disposed at the anterior end of the leg  152 , and a second pedestal  164  disposed at the anterior end of the leg  154 . The pedestals  160  and  164  each include a respective stand  162 ,  166 , each of which has an angulation notch (of which only notch  168  is easily discernable). This allows a change in elevation of the elevator  150  relative to the frame component  20 .  
         [0082]     The elevator  150  is adapted, configured and/or operative to withstand some pressure applied thereto, especially the bottom thereof. Moreover, the elevator  150  is designed to distribute applied pressure evenly thereabout. This alleviates a pressure point when applied to the frame.  
         [0083]     Referring now to  FIG. 13 , there is depicted the frame component  20  having first and second compression bars, rails, member, components or the like generally designated  200   a  and  200   b . The compression rails  200   a ,  200   b  are preferably, but not necessarily, identical. The compression rails  200   a  and  200   b  are each configured to be releasably and/or adjustably received on the respective sides  25  and  24  of the frame, and particularly of the posterior portion thereof. As best seen in  FIG. 14 , wherein each rail  200   a  and  200   b  is represented by the compression rail  200 .  
         [0084]     In  FIG. 14 , the compression rail  200  is defined by a body  202  having a plurality of fixation bores  204  configured to receive wire fixation posts and/or members and a side bore  205 . The body  202  defines a slot or channel  210  that is dimensioned to fit around the frame. In this manner the rail  200  is slidably adjustable on the frame. First and second transverse walls  206  and  208  extend from the body  202  and provide a guide for any fixation wires.  
         [0085]     As seen in  FIG. 15 , various fixation wires  220  are provided in the medial/lateral direction from one compression rail  202   a  to the other compression rail  202   b  (although not shown fixed or attached thereto for clarity). These medial/lateral fixation wires can create anterior/posterior compression on the bone (e.g. foot/ankle). Placement of the compression rails may be staggered (i.e. not in the same position on each side of the frame).  
         [0086]     Referring now to  FIG. 16 , there is depicted the frame component  20  having first and second compression bars, rails, member, components or the like generally designated  230   a  and  230   b . The compression rails  230   a ,  230   b  are preferably, but not necessarily, identical. The compression rails  230   a  and  230   b  are each configured to be releasably and/or adjustably received on the respect to sides  25  and  24  of the frame, and particularly of the posterior portion thereof. As best seen in  FIG. 17 , wherein each rail  230   a  and  230   b  is represented by the compression rail  230 .  
         [0087]     In  FIG. 17 , the compression rail  230  is defined by a body  232  having a plurality of fixation bores  234  configured to receive wire fixation posts and/or members and a side post  238 . The body  232  has one or more mounting pegs  236  that are dimensioned to fit into the fixation bores of the frame. In this manner the compression rail  230  may be removably positioned almost anywhere along the frame.  
         [0088]     As seen in  FIG. 18 , various fixation wires, rods or the like  250  are provided in the medial/lateral direction from one compression rail  232   a  to the other compression rail  232   b  (although not shown fixed or attached thereto for clarity). These medial/lateral fixation wires can create anterior/posterior compression on the bone (e.g. foot/ankle). Placement of the compression rails may be staggered (i.e. not in the same position on each side of the frame).  
         [0089]     In  FIG. 19 , there is depicted a bottom view of an alternative embodiment of an external ankle/foot fixation device generally designated  300 . The fixation device  300  includes a frame  302  having a plurality of frame holes  304 . A cross bar  306  extends across the frame  302 . In accordance with an aspect of this embodiment, the fixation device  300  includes first and second compression rails  308  and  310 . The compression rails  308 ,  310  each have a respective set of holes  312 ,  314 . The holes  312 ,  314  allow the receipt of fixation posts/members for receiving fixation wires. As represented by the arrows, the compression rails  308 ,  310  limitedly move in an anterior/posterior direction. Other manners of providing controlled compression may be utilized. Various combinations of the above compression rails may be provided.  
         [0090]     As seen in  FIGS. 1 and 7 , the frame  20  includes numbers or calibration markings as indicated above. These marking may be calibrated and/or used with respect to other fixation components not shown herein. The markings match the markings of the other fixation components for alignment of the foot frame to threaded rods. For example, rings with threaded rods may be used in addition to the present foot frame. These components have the calibration markings that are then compatible with the calibration markings of the present fixation device.  
         [0091]     In another form, the markings may correspond to holes in other, non-marked components. For instance, another component may have a plurality of holes. Hole number of the other component would correspond to the number marking on the frame. Thus, if a fixation device was retained in a hole counted to be “12”, the fixation wire attached thereto would correspond to the marking “12” on the frame, to which the other end of the fixation wire would be attached.  
         [0092]     The frame or frame component in each case keeps the fixation wires straight (or relatively straight) with relation to the various clamping surfaces thereof. Further, the curvature of the frame is such as to preferably follow the shape of the bone/joint or placement area. Typically, the frame (posterior portion) is curved or arcuate and thus has a radius or radius of curvature particularly between the horizontal and vertical planes. This radius is preferably formed as a stress reduction radius. As such, the radius should be between 0.06 inches and 1.5 inches.  
         [0093]     Moreover, the material from which the frame is fabricated should have little to no flexibility. This will address any springback and/or tensioning of the fixation wires situated thereon or thereby. Therefore, the frame is designed with A/P forces that tend to close the frame in mind. Particularly, the frame should be stiff enough to that under tension it will flex less than 0.5 mm in the transverse plane and less than 2.0 mm in the coronal plane.

Technology Category: a