Abstract:
The invention involves an osteogenic mandibular distraction device. The device is particularly suited for bucchal installation. The device comprises a thoracic member having a fore end and an aft end; a tail member slidably engaged to the thoracic member at the aft end thereof, thereby defining a longitudinal axis between the thoracic member and the tail member, and having a tail member fastening feature for attachment with respect to a first boney structure; an axial extender rotatably attached with respect to the thoracic member, extending therefrom in an aft direction, and engaged with respect to the tail member, whereby a distance between the thoracic member and the tail member may be variably established; a head member; and a rotator attached with respect to the fore end of the thoracic member allowing specific and fixable rotational positioning transverse to the longitudinal axis of the head member with respect to the thoracic member. The head member has a rear portion pivotably attached with respect to the fore end of the thoracic member, and a forward portion with a forward fastening feature for attachment with respect to a second boney structure.

Description:
FIELD OF THE INVENTION  
         [0001]    This invention relates to orthodontic devices, particularly those involving osteogenic distraction.  
         BACKGROUND OF THE INVENTION  
         [0002]    Malocclusion is the misalignment of the maxillary and mandibular teeth when the jaw is closed. Severe malocclusion requires orthodontic intervention for proper dentofacial biomechanics. Similarly, it is necessary for orthodontic intervention for congenital micrognathia or mandibular defects due to trauma or disease. If left untreated, malocclusion and other mandibular defects can lead to headaches, pain, disfigurement, premature wearing of the teeth, and eventual tooth loss.  
           [0003]    In applications in which the mandible is short relative to the upper jaw (recessive malocclusion), the mandible needs to be distended.  
           [0004]    The process of extending the bone is known alternatively as osteogenesis, osteosynthesis, or osteodistraction. In general terms, the living bone to be lengthened is cut perpendicularly to the direction of distraction. The bone is then separated and braced. After new bone has filled the gap created by the distraction and ossified, the brace can be removed.  
           [0005]    Under present procedure for mandibular distraction, an adjustable mechanism is installed to the lateral aspect of at least one ramus under the masseter muscles and also attached by surgical pins to the body of the mandible. The mandible is then transected between the points of installation and attachment. Incremental adjustments by application of the device distends the mandible body anteriorly relative to the ramus over time to maintain directional placement as the connective tissue is lengthened to allow for osteogenesis along the line of transection.  
           [0006]    There are a number of appliances available to an orthodontist for correcting malocclusion. One type of appliance uses a small screw jack attached to selected teeth. The devices of Guerrero et al. (U.S. Pat. No. 5,885,290) and Gittleman (U.S. Pat. No. 5,885,283) constitute an attempt at providing a distraction device for distention of the mandible. These devices allow for distention along one line of travel.  
           [0007]    While the majority of the mandibular distraction motion is in an anterior direction along one axis, malformations and traumatic reconstructions often require movement along other than a single linear direction.  
           [0008]    The device of Schendel (U.S. Pat. No. 5,700,263) allows for bidirectionality in adjustment. Such bidirectionality, however, must be predetermined prior to installation of the apparatus. Moreover, the Schendel device does not allow for different rates of distraction between the various dimensional adjustments.  
           [0009]    An osteogenic distraction device facilitating easy adjustment in each of two dimensions, adjustment in either dimension independent of adjustment in the other dimension, would be an important improvement in the art.  
         OBJECTS OF THE INVENTION  
         [0010]    It is an object of the invention to provide an osteogenic distraction device that overcomes some of the shortcomings of the prior art.  
           [0011]    It is another object of this invention to provide an osteogenic distraction device which is easy to install to a mandible.  
           [0012]    It is still another object of this invention to provide an osteogenic distraction device which is easily adjustable.  
           [0013]    It is yet another object of this invention to provide an osteogenic distraction device which is easily adjustable by a patient into whom a device has been implanted.  
           [0014]    It is still yet another object of this invention to provide an osteogenic distraction device which is easily customizable by a surgeon before placement of a device into a patient.  
           [0015]    It is a further object of this invention to provide an osteogenic distraction device which once implanted does not need invasive surgery for removal.  
           [0016]    It is a still further object of this invention to provide an osteogenic distraction device which minimizes the chance of infection once implanted within the body.  
           [0017]    Another object of this invention is to present an osteogenic distraction device which allows for easy adjustment within either of two dimensions independent of any adjustment in the other dimension.  
           [0018]    Yet another object of this invention is to present an osteogenic distraction device which minimizes the number of fixation devices necessary to adequately anchor the distraction device to the patient.  
           [0019]    Still another object of this invention is to provide an apparatus and method for minute, incremental distraction adjustments to maximize bone growth and establish long-term bone health.  
           [0020]    Even yet another object of the invention is to maintain a union of two sections of bone as the connective tissue is lengthened and new bone is created within the transected gap.  
           [0021]    How these and other objects are accomplished will become apparent from the following descriptions and from the drawings.  
         SUMMARY OF THE INVENTION  
         [0022]    The invention involves an osteogenic mandibular distraction device. The device is particularly suited for bucchal installation. The device comprises a thoracic member having a fore end and an aft end; a tail member slidably engaged to the thoracic member at the aft end thereof, thereby defining a longitudinal axis between the thoracic member and the tail member, and having a tail member fastening feature for attachment with respect to a first boney structure; an axial extender rotatably attached with respect to the thoracic member, extending therefrom in an aft direction, and engaged with respect to the tail member, whereby a distance between the thoracic member and the tail member may be variably established; a head member; and a rotator attached with respect to the fore end of the thoracic member allowing specific and fixable rotational positioning transverse to the longitudinal axis of the head member with respect to the thoracic member. The head member has a rear portion pivotably attached with respect to the fore end of the thoracic member, and a forward portion with a forward fastening feature for attachment with respect to a second boney structure. In this way, variable bidirectional adjustment may be obtained between the tail member fastening feature and the forward fastening feature. By the term “bidirectional adjustment”, it is meant that adjustment may be made independently in either linear direction, or cooperatively to obtain a rotational movement within a plane.  
           [0023]    In one preferred embodiment, at least one of the fastening features is a plate extending out from the device, into which at least one hole may be created. It is more preferable for the at least one plate to be bioabsorbable. By “bio-absorbable”, it is meant that the material of which the plate is made, will, over time, be broken down within the body (human or otherwise) into which it is placed, and be absorbed or adsorbed, ultimately being expelled by natural organic processes, without the need for surgical removal.  
           [0024]    It is also preferable in this embodiment for the at least one plate to be alterable after manufacture but before installation. It is yet more preferable to have at least one pre-placed discontinuity to allow for separation along the discontinuity when purposeful pressure is applied perpendicularly to the plate. This discontinuity could be, by way of illustration only, and not limitation, a perforation or scoring.  
           [0025]    In another preferred embodiment, the at least one plate is a mesh which inherently provides a plurality of screw-receiving ports.  
           [0026]    In another preferred embodiment the axial extender is threaded. It is more preferable when the axial extender is a jack screw.  
           [0027]    In yet another preferred embodiment, the rotator is threaded. In a different preferred embodiment, the rotator is geared.  
           [0028]    It is still yet another embodiment of this osteogenic mandibular distraction device to further comprise: (a) at least one guide having a cross-sectional shape extending from the aft end of the thoracic member; and (b) at least one guide receptor on the tail member with a receptor space of a shape complementary to the guide cross-sectional shape. In this way, the tail member will slide along the guide as the relative distance between the thoracic member and the tail member is varied.  
           [0029]    It is another aspect of this invention to provide a method of osteogenic mandibular distraction. This method comprises the steps of:  
           [0030]    (a) obtaining a osteogenic mandibular distraction device having: (i) a thoracic member having a fore end and an aft end; (ii) a tail member slidably engaged to the thoracic member at the aft end thereof, thereby defining a longitudinal axis between the thoracic member and the tail member, and having a tail member fastening feature for attachment with respect to a first boney structure; (iii) an axial extender rotatably attached with respect to the thoracic member, extending therefrom in an aft direction, and engaged with respect to the tail member, whereby a distance between the thoracic member and the tail member may be variably established; (iv) a head member; and (v) a rotator attached with respect to the fore end of the thoracic member allowing specific and fixable rotational positioning transverse to the longitudinal axis of the head member with respect to the thoracic member;  
           [0031]    (b) severing the bone of the mandible in a transverse band thereby separating a labial portion of the mandible from a cranial portion of the mandible;  
           [0032]    (c) fixing the forward fastening feature with respect to the bone on one side of the separation in the mandible;  
           [0033]    (d) adjusting the rotator to a fixed, preferred rotational position between the head member and the thoracic member;  
           [0034]    (e) fixing the tail member fastening feature with respect to the bone on the opposite side of the separation in the mandible; and  
           [0035]    (f) over time, incrementally varying the axial distance between the thoracic member and the tail member; thereby producing mandibular distraction. The head member of this osteogenic mandibular distraction device has a rear portion pivotably attached with respect to the fore end of the thoracic member, and a forward portion with a forward fastening feature for attachment with respect to a second boney structure.  
           [0036]    It is preferable for the fixation of the fastening features to be accomplished through screws. It is more preferable for the screws to be bioabsorbable.  
           [0037]    Another aspect of this invention is an osteogenic distraction device for oral installation. The device comprises: (a) a thoracic member having a fore end and an aft end; (b) a tail member slidably engaged to the thoracic member at the aft end thereof, thereby defining a longitudinal axis between the thoracic member and the tail member, and having a tail member fastening feature for attachment with respect to a first boney structure; (c) an axial extender rotatably attached with respect to the thoracic member, extending therefrom in an aft direction, and engaged with respect to the tail member, whereby a distance between the thoracic member and the tail member may be variably established; (d) a head member having a rear portion pivotably attached with respect to the fore end of the thoracic member, and a forward portion with a forward fastening feature for attachment with respect to a second boney structure; and (e) a rotator attached with respect to the fore end of the thoracic member allowing specific and fixable rotational positioning transverse to the longitudinal axis of the head member with respect to the thoracic member. In this way, variable bidirectional adjustment may be obtained between the tail member fastening feature and the forward fastening feature. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0038]    The drawings illustrate preferred embodiments which include the above-noted characteristics and features of the invention. The invention will be readily understood from the descriptions and drawings. In the drawings:  
         [0039]    [0039]FIG. 1 is a top view of the device according to the invention with a starboard tab.  
         [0040]    [0040]FIG. 2 is a side view of the side of the device of FIG. 1.  
         [0041]    [0041]FIG. 3 is a end view of the anterior of the device of FIG. 1.  
         [0042]    [0042]FIG. 4 is a end view of the posterior of the device of FIG. 1.  
         [0043]    [0043]FIG. 5 is a top view of an alternative embodiment of a device according to the invention.  
         [0044]    [0044]FIG. 6 is a partial cut-away top view of the device of FIG. 5.  
         [0045]    [0045]FIG. 7 is a side view of a partially disassembled device of FIG. 5.  
         [0046]    [0046]FIG. 8 is a cut-away top view of the device of the device of FIG. 5 with the jack screw displaced producing rotation.  
         [0047]    [0047]FIG. 9 is a top view of the device of FIG. 1 with alternative embodiments of uniting tabs having supplemental fixation plates.  
         [0048]    [0048]FIG. 10 is a side view of the device of FIG. 9.  
         [0049]    [0049]FIG. 11 is a top view of the device of FIG. 1 installed in a mandible. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0050]    [0050]FIG. 1 shows the device  10 . Device  10  has a head section  20 , a thoracic section  22 , and an abdominal section  24 . By the terms “head”, “thoracic”, and “abdominal”, applicants are not referring to anatomical parts of the human anatomy, but rather three distinct and aligned members of device  10 . For directional convention in describing the device herein, head section  20  is deemed anterior and abdominal section  24  is deemed posterior along a longitudinal dimension.  
         [0051]    Head section  20 , thoracic section  22 , and abdominal section  24  are rigid and must be strong enough to provide the jaw adequate support when the device is installed spanning the transection (as described below) of the mandible while the bone is generating. Unless otherwise discussed, metal and in particular, surgical-grade stainless steel, is preferred for the composition of the components of device  10 .  
         [0052]    As shown in FIG. 1, when viewed from above, thoracic section  22  has a roughly rectangular posterior thoracic portion  26  and a tapered-neck-shaped anterior thoracic portion  28  (shown in phantom) integral with posterior thoracic portion  26 .  
         [0053]    Extending posteriorly out from posterior thoracic portion  26  is a longitudinal motion director. As shown in FIGS.  1 - 4 , longitudinal motion director is a glide  30 . Glide  30  is most preferably a U-shaped channel. The purpose of a longitudinal motion director is to allow abdominal section  24  to slide along glide  30  with respect to thoracic section  22  but to constrain the sliding movement to one dimension and prohibit rotation of abdominal section  24  with respect to thoracic section  22 . It can be easily understood that any mechanism, such as two parallel, longitudinal bars ( 31  as shown in FIG. 5) extending posteriorly from thoracic section  22  would provide sufficient structure to keep abdominal section  24  traveling in one dimension with respect to thoracic section  22 . It has been found that U-shaped channel glide  30  is best suited for sanitary intra-oral application by eliminating pockets into which debris, microorganisms, or tissue may accumulate.  
         [0054]    Also extending posteriorly from thoracic section  22  and parallel to glide  30  is a threaded longitudinal jack screw  32  capable of rotation about a longitudinal jack screw axis  34  without travel into thoracic section  22 .  
         [0055]    Both glide  30  and jackscrew  32  engage abdominal section  24 .  
         [0056]    Abdominal section  24 , as viewed from the top, is roughly rectangular in shape.  
         [0057]    As seen in FIG. 4, extending horizontally through abdominal section  24  from the interior side to the posterior side, are two cavities, the glide-receiving cavity defined by glide-receiving cavity wall  36  and the jack-screw-receiving cavity defined by jack-screw-receiving cavity wall  38 . Glide-receiving cavity wall  36  is U-shaped and dimensioned to allow abdominal section  24  to slide along glide  30  but with sufficiently tight tolerance to prevent accumulation of debris and/or tissue in the space between glide  30  and glide-receiving cavity wall  36 .  
         [0058]    Jack-screw cavity wall  38  is threaded to accommodate longitudinal jack screw  32 . At the posterior end of jack screw  32  is adjustment head  42 . It is the purpose of adjustment head  42  to allow longitudinal adjustment along longitudinal jack screw axis  34  by turning of a wrench. Any means of turning jack screw  32  about its axis  34  to cause movement of abdominal section  24  along glide  30  is sufficient for purposes of the invention. As seen in FIG. 6, when jack screw  32  is rotated, abdominal section  24  may be moved along longitudinal motion director.  
         [0059]    As seen in FIG. 1, when viewed from the top, extending out from abdominal section  24 , perpendicular to longitudinal jack screw axis  34  of jack screw  32  is an abdominal fixation tab  44 . As better seen FIG. 4, abdominal fixation tab  44  is integral with abdominal section  24 . As shown, abdominal fixation tab  44  has three screw-receiving apertures  46 . Screw-receiving apertures  46  are designed to receive fixation screws  48  (shown in phantom in FIG. 4). Fixation screws  48  are driven through screw-receiving apertures  46  to allow securing of device  10  to a mandible  50 . Fixation screws  48  may be either of surgical-grade stainless steel or alternatively of a biodigestable material for absorption into the body over time. In this latter manner, removing device  10  from the oral cavity is facilitated. Rather than removing each fixation screw  48  from their place of fixation within mandible  50 , the screw head  52  may be cut off and device  10  may be removed while screw body  54  remains in the jaw for absorption over time by the human body.  
         [0060]    It should be noted that, as shown in FIG. 1, abdominal fixation tabs  44  extend out from the starboard side of abdominal section  24 . This version of device  10  may be used on either side of the jaw, although the embodiment shown in FIG. 1 is best suited for buccal installation in the left jaw. Alternatively, for right-side buccal installation, a similarly shaped abdominal fixation tab  44  may extend on the port side of abdominal section  24 . In addition, it is easily understood that such abdominal fixation tab  44  may extend axially outwardly from the posterior end of abdominal section  24 .  
         [0061]    Posterior portion  26  of thoracic section  22  is rectangular with a laterally-running thoracic-section posterior side  56 , and has opposed longitudinally-running, parallel, posterior-portion thoracic-section, lateral sides  58 ,  60  each perpendicular to the thoracic-section posterior side  56 . Posterior-portion thoracic-section lateral sides  58 ,  60  are spaced apart by a lateral dimension D1. Anterior portion  28  of thoracic section  22  engages head section  20  at a post-engaging arrangement  62 .  
         [0062]    In the preferred embodiment, post-engaging arrangement  62  consists of fork with two tines  64  defining a post-receiving cavity  66 . Tines  64  have longitudinally-running tine sides  68  separated by a lateral distance D2 which is approximately one-third of the lateral distance D1. Tying the most posterior point of each tine side  68  to the most anterior point of each posterior-portion thoracic-section lateral side  56  are anterior-portion angled sides  70 . Angled sides  70  are positioned approximately 45° from each posterior-portion thoracic-section lateral side  58 ,  60 . By providing an angular distance between post-engaging arrangement  62  and posterior-portion thoracic-section lateral side  56 , clearance is provided for rotation of thoracic section  22  with respect to head section  20 .  
         [0063]    As seen in side view of FIG. 2, anterior portion  28  has a smaller transverse dimension than posterior portion  26 . Extending transversely through anterior portion  28  is a pivot cavity  72 .  
         [0064]    Head section  20  has a roughly rectangular cross-section, comprised of an upper piece  74 , lower piece  76 , port piece  78 , and starboard piece  80  and is substantially hollow. Port piece  78  and starboard piece  80  are dimensioned to provide adequate support for head jack screw  92 , but do not extend the full length of head section  20  to provide an opening at the posterior end of head section  20  whereby anterior portion angled sides  70  may travel a distance as thoracic section  22  is pivoted with respect to head section  20 , without obstruction by posterior edges of port and starboard pieces  78 ,  80 .  
         [0065]    In the preferred embodiment, upper piece  74 , lower piece  76 , port piece  78 , starboard piece  80 , and a head tab  81  are integrated to form one, continuous housing with rounded corners and sides. This unibody design of head-section  20  decreases opportunity for tissue-holding pockets and, with the rounded corners and edges, allows for travel along tissues as device  10  is being adjusted in operation within the body.  
         [0066]    Extending transversely through a point at the posterior of upper piece  74  and through a point at the posterior of lower piece  76  of head section  20  are upper head pivot hole  82  and lower head pivot hole  84 , respectively. Extending through upper head pivot hole  82 , pivot cavity  72 , and lower head pivot hole  84 , is a pivot pin  86 . Pivot pin  86  is dimensioned to be flush with the upper surface of upper piece  74  and the lower surface of lower piece  76  to provide comfortable, smooth surfaces for the wearer.  
         [0067]    As seen in FIGS. 1 and 2, device  10  (and the similar mechanism shown in an alternate embodiment as device  100  of FIGS.  5 - 8 ) includes a head jack screw  92  which is supported by head port piece  78  and head starboard piece  80 , and extends laterally through head section  20 . Head jack screw  92  is threaded and is capable of being rotated around about head jack screw axis  94  without travel. Rotation of thoracic section  22  in the embodiment shown in FIGS.  1 - 4 , is accomplished by means of a standard key (not shown) removably placed in a key hole  96  to lever torque to head jack screw  92 . It is well known in the industry that other methods are equally effective to induce torque. One such alternate method is shown in the embodiment of FIGS.  5 - 8 , wherein rotation of the thoracic section  22  is accomplished by inducing torque through a wrench applied to wrench-receiving head  99 .  
         [0068]    Attached to head jack screw  92  is a head pivot device  98 . Head pivot device  98  has a anterior threaded portion  100  and a posterior post-holding portion  102 . Anterior threaded portion  100  engages head jack screw  92 . It should be noted that, while in the embodiment of FIGS.  1 - 4 , head pivot device  98  is of a generally “L” shape configuration which complementarily receives post-engaging arrangement  62  which is of a generally inverted “L” shape, in the embodiment of FIGS.  5 - 8 , the anterior portion of thoracic section  22  of FIG. 7 has upper and lower arms  165  extending horizontally out therefrom defining a nub-receiving cavity  167  therebetween. Head pivot device  98  of FIGS.  5 - 8  includes threaded anterior portion  100 , post-holding portion  102  and post  104  that extends through post-receiving cavity  66  of the extreme anterior portion  28  of thoracic section  22 . Post-receiving portion  102  has a nub configuration which is complementary with nub-receiving cavity  67 . These are but two possible methods of providing rotation of the head section  20  with respect to the thoracic section  22 .  
         [0069]    In this manner, as head jack screw  92  is rotated about its axis  94 , head pivot device  98  (including post  104 ) travels along jack screw axis  94 , which in turn rotates anterior portion  28  of thoracic section  22  about pivot pin  86  thereby arcuately moving abdominal section  24  with respect to head section  20  (as best seen in FIG. 8).  
         [0070]    Extending out anteriorly from head section  20  is head tab  81 . Head tab  81  may extend out from head section  20  in any manner which can accommodate fixation to the jaw, such as laterally or radially from head section  20 . Head tab  81  has three fixation screw apertures  108  to receive fixation screws  110 . As discussed with regard to installation of the abdominal fixation tab  44 , head fixation screws  110  may be either stainless steel or bioabsorbable for installation into a jaw.  
         [0071]    FIGS.  5 - 8  illustrate another embodiment of the invention identified as device  100 , which includes many common components with device  10 , depicts alternative embodiments of the post-engaging arrangement and tail member. For clarity, the components of device  100  which are common with the components of device  10  will be identified by identical numerals. Like device  10 , device  100  includes a head section  20 , a thoracic section  22 , and an abdominal section  24 . Device  100  also includes an abdominal fixation tab  144  located on the port side of device  100 . As discussed above with regard to fixation tabs  44  of device  10 , abdominal fixation tabs  144  may be located on either the port or starboard sides of device  100  to accommodate installation in the mouth. Device  100  is installed within the mouth through the use of a single fixation screw (not shown) extending through screw hole  146  into the jaw. In a similar manner, head tab  181  has one screw hole  146  for a single fixation screw.  
         [0072]    As human mouths come in an infinite array of sizes and shapes with an infinite need for adjustment, it is desirable to provide placement options for the surgeon installing the device. The device  200  depicted in FIGS. 9 and 10 illustrate substantially the same device of FIGS.  1 - 8  but with alternative types of fixation that is more easily customizable by an installer of the device prior to installation.  
         [0073]    Device  200  includes a head uniting tab  281  which extends anteriorly longitudinally from head section  20  and a abdominal uniting tab  244  which extends out from abdominal section  24  (at either port or starboard, as desired), perpendicular to longitudinal jack screw axis  34 .  
         [0074]    As shown in FIGS.  9 - 10 , head uniting tab  281  has a plate-uniting hole  246 . Attached to head uniting tab  281  is an anterior customizing plate  300 . Anterior customizing plate  300  has a tab-uniting hole  247 . Head uniting tab  281  is secured to customizing plate  300  by a fastener  310  which extends through plate-uniting hole  246  and tab-uniting hole  247 . Fastener  310  may be of any suitable type, such as a rivet, and may be made of any suitable material, such as surgical-grade stainless steel or a biodigestable material.  
         [0075]    Similarly, abdominal uniting tab  244  has a plate-uniting hole  246  and is likewise secured to a customizing plate  312  by fastener  310 . It can be appreciated that, like fixation tabs  44  and  81  of device  10 , head uniting tab  281  and abdominal uniting tab  244  may extend out from head section  20  and abdominal section  24 , respectively, in any direction which facilitates installation of devices  10 ,  100  or  200  in the mouth. Futhermore, anterior customizing plate  300  may be secured to head section  20  by any suitable method, such as pinned, screwed or welded to the anterior end wall  286  or a side wall  288 ,  290  of head section  20 . Similarly, customizing plate  312  may be secured to abdominal section  24  in any suitable manner.  
         [0076]    In the preferred embodiment shown in FIGS.  9 - 10 , the lower surface  282  of head uniting tab  281  and the lower surface  245  of abdominal uniting tab  244  are located at a distance spaced from the lower surface  284  of head section  20  and the lower surface  248  of abdominal section  24 , respectively, approximately equal to the thickness of customizing plates  300 ,  312  to provide a continuous, flush lower surface along device  200 .  
         [0077]    Customizing plates  300 ,  312  may be made of any suitable material with sufficient strength to withstand lateral stresses in treatment operation would be acceptable, most preferrably a surgical-grade plastic or biodigestble material. Customizing plates  300 ,  312  may be manufactured in any shape or configuration desired, such as a mesh as illustrated by customizing plate  300 , or a sheet as illustrated by customizing plate  312 . Mesh customizing plate  300  may be trimmed to accommodate or customize the shape thereof to the wearer and further allows the device of the invention to be secured to the wearer by screws at any location desired on mesh customizing plate  300 .  
         [0078]    Sheet customizing plate  312  may include pre-drilled apertures  314  at predetermined locations thereon to facilitate attachment of the device of the invention to the wearer. Sheet customizing plate  312  may also include scored separation lines  316  which provides easy customization of the shape of sheet customizing plate  312  to accommodate the wearer.  
         [0079]    FIGS.  5 - 8  and  11  also demonstrate a method for osteogenic distraction.  
         [0080]    Under anesthetic, an incision is made on the buccal side of the oral cavity allowing the gum to pulled aside providing access to the ramus under the masseter muscle and access to mandible  50 . In the preferred method, an initial cut is made vertically along the mandible  50 . Prior to complete transection, fixation of the device of the invention within the mouth is accomplished.  
         [0081]    Specifically, fixation screws  110  are driven through fixation apertures  108  of head tab  81  into the ramal portion of mandible  50  or into the ramus. While in an undistended position (with thoracic section  22  touching abdominal section  24 ), abdominal fixation tab  44  (preferably extending downwardly) is affixed to the labial side of the partial transection and affixed to mandible  50  by means of fixation screws  48 .  
         [0082]    The remainder of the transection is accomplished with care being taken not to disturb the non-boney, filamentary connective tissue portions of mandible  50 .  
         [0083]    By operation of head jack screw  92  and longitudinal jack screw  32 , slight distending adjustment is made thereby separating thoracic section  22  from abdominal section  24  at periodic temporal intervals, at the direction of the surgeon. As additional rotations are provided to longitudinal jack screw  32 , the jaw is additionally distended. Slowly widening the gap while maintaining the integrity of the connective-tissue blood supply improves the creation of new bone-forming tissue.  
         [0084]    Further, if rotational motion of the jaw is required for proper positioning, in addition to longitudinal distension, torque may be applied to head jack screw  92 . As head jack screw  92  rotates in both clockwise and counter-clockwise directions, rotation of the jaw is available upwardly and downwardly about the transection. It will be noted that adjustment may be made by longitudinal jack screw  32  independent of operation of head jack screw  92  thereby allowing for fine adjustments during the course of treatment.  
         [0085]    It is preferable to mount device of the invention under the gum, adjacent to the bone, but, it is acceptable to mount the device of the invention superficially to the gum within the oral cavity.  
         [0086]    At the conclusion of treatment and after ossification of generated bone in the gulf provided by the transection and distension, the device of the invention will be removed.  
         [0087]    All parts can be fashioned from biocompatible stainless steel since this apparatus will remain in place only for up to eight weeks while bone is formed in the lengthening gap. If the device was affixed with metal or other non-bioabsorbable fixation screws  48 , fixation screws  48  will be removed from the body thereby releasing the device and allowing it to be removed from the body.  
         [0088]    If bioabsorbable screws or pins were used to affix the device to mandible  50 , the heads  52  of fixation screws  48  may be cut off thereby allowing for removal of the device with retained placement of the bioabsorbable body  54  of fixation screws  48 .  
         [0089]    To avoid sharp edges and pain at the site, the remaining core of body  54  of fixation screw  48  may be cut, filed or polished.  
         [0090]    Alternatively, if customizable plates such as  300 ,  312  depicted in FIGS.  9 - 10  are made of bioabsorbable material along with fixation screws  48 , customizable plates  300 ,  312  may be separated from device  200  at a location anywhere between fixation screws  48  and device  200  to allow for removal of the metallic portion of distension device  200  from the oral cavity. In this latter regard, the body will absorb the bioabsorbable material and allow for natural osteogenic repair of the screw holes.  
         [0091]    While the principles of the invention have been shown and described in connection with but a few embodiments, it is to be understood clearly that such embodiments are by way of example and are not limiting.