PATENT ABSTRACT
The described embodiments relate to a transport prosthesis and a distraction device, which is surgically implanted against a bone, for the purpose of growing new bone through the process of distraction. The transport prosthesis is designed to be affixed to a patient&#39;s jaw to support the distraction device. The distraction device comprises a screw mechanism that attaches to a threaded post, which extends through tissue from an onlay plate that is surgically placed on the alveolar bone. After a brief, latent period, the screw mechanism is then activated daily until the desired amount of new bone growth is achieved.

PATENT DESCRIPTION
[0001]    This application claims priority to U.S. Provisional Patent Application No. 61/294,742, filed on Jan. 13, 2010, the entirety of which is incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    Embodiments described herein relate generally to dental implant systems and methods for growing new bone, more particularly, to dental implant systems and methods for encouraging new bone growth in areas of the mouth that have suffered bone loss and most particularly to transport prostheses and distraction devices and methods for forming new bone growth and soft tissue by distraction osteogenesis in areas of the jaw bone. 
       BACKGROUND 
       [0003]    Orthopedic surgeons have conventionally relied upon the process of distraction osteogenesis to reconstruct and lengthen bones. This process may involve placing a vascularized piece of bone under tension, thereby inducing native bone formation via the creation of a bony reparative callus, which can then be placed under tension to generate new bone. To effect distraction osteogenesis, a surgeon generally performs an osteotomy where sectioning or segmenting the bone into more than one piece occurs. As the bone segments heal, they will gradually expand over a period of time; the gradual expansion allows the blood vessels and nerve ends to remain intact during the distraction process. For example, the bone may extend a millimeter a day, often by performing two extensions of half a millimeter, for three or four days which allow the blood vessels and nerve ends to remain intact. 
         [0004]    As the gap between the bone segments widens, the natural healing capacity of the body can fill the void with new bone and adjacent soft tissue. Once the desired bone formation is achieved, the area may be allowed to heal and consolidate. Often, the distraction osteogenesis device is then removed. 
         [0005]    Premature tooth loss may limit a patient&#39;s ability to chew and speak clearly. Tooth replacement is one solution to this problem. Conventionally, dentists have been able to replace missing teeth by various means. For example, a patient may be fitted with a removable prosthesis, such as partial or complete dentures. Another option is the placement of fixed bridge work cemented to adjacent teeth. While these conventional methods serve to fill the void of the edentulous space by replacing the crown of the involved teeth, they fail to cure other problems associated with premature tooth loss, such as bone deterioration. 
         [0006]    Bone deterioration limits the surgical options available to dentists and may necessitate a dentist to place a smaller than optimal sized dental implant. These smaller dental implants often cannot accommodate the mechanical load from chewing, and ultimately may loosen and/or fail. Moreover, the bone deterioration may cause a dental implant to be placed in a location that is not as aesthetically or functionally optimal. 
         [0007]    One prior solution to this bone deterioration problem, if the bone loss was not significant, was to augment the bony bed with the patient&#39;s own bone, cadaveric bone, or with synthetic bone substitutes. In cases where the bone loss is significant, the bone augmentation must be done as a first surgical procedure with the placement of the dental implant occurring several months later, as a second surgical procedure, once healing of the bone graft is completed. 
         [0008]    There is a need for a new distraction device and method for allowing the rapid regeneration of new bone growth, reducing a patient&#39;s aesthetic concerns, reducing the need for bone grafts, and preventing the actual cutting of the bone in an area of bone deficiency. 
       BRIEF SUMMARY 
       [0009]    Various embodiments described herein relate to a transport prosthesis, which is temporarily installed in a patient&#39;s mouth, and supports a distraction device for promoting new bone growth through the process of distraction. In various embodiments, the transport prosthesis provides an aesthetically pleasing prosthesis that also allows a patient to chew, provides one or more drill guides for preparing a site for a permanent tooth implant, and/or provides a support, or transport, for a distraction device for regrowing bone. 
         [0010]    Other embodiments described herein relate to a distraction device, which is surgically implanted, for promoting new bone growth through the process of distraction. A specific embodiment includes a device having an expansion component that attaches to a threaded post, which extends through tissue (transmucosa) from a plate, and is surgically placed on the alveolar bone. After a brief, latent period, the expansion component of the device is activated daily until the desired amount of new bone growth is achieved. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  is a top and back perspective view of a transport prosthesis in accordance with an embodiment described herein. 
           [0012]      FIG. 2  is a top and side perspective view of the transport prosthesis shown in  FIG. 1 . 
           [0013]      FIG. 3  is a bottom view of a portion of the transport prosthesis shown in  FIG. 1 . 
           [0014]      FIG. 4  is a top and back perspective view of the transport prosthesis shown in  FIG. 1 . 
           [0015]      FIG. 5  is a top view of covers to be used with the transport prosthesis shown in  FIG. 1 . 
           [0016]      FIG. 6  illustrates a portion of a distraction device in accordance with an embodiment described herein. 
           [0017]      FIG. 7  illustrates a distraction device and a portion of a transport prosthesis in accordance with an embodiment described herein. 
           [0018]      FIG. 8  illustrates a distraction device and a portion of a transport prosthesis in accordance with another embodiment described herein. 
           [0019]      FIG. 9  is a bottom and side perspective view of a portion of the transport prosthesis shown in  FIG. 1  and a portion of a distraction device. 
           [0020]      FIG. 10  is a front and bottom perspective view of a transport prosthesis in accordance with an embodiment described herein. 
           [0021]      FIG. 11  is a bottom and side perspective view of the transport prosthesis shown in  FIG. 10 . 
           [0022]      FIG. 12  is a front and bottom perspective view of the transport prosthesis shown in  FIG. 10 . 
           [0023]      FIG. 13  is a front and bottom perspective view of a transport prosthesis in accordance with an embodiment described herein. 
           [0024]      FIG. 14  is a front and bottom perspective view of the transport prosthesis shown in  FIG. 13 . 
           [0025]      FIG. 15  is a front and bottom perspective view of a transport prosthesis in accordance with an embodiment described herein. 
           [0026]      FIG. 16  is a front and bottom perspective view of the transport prosthesis shown in  FIG. 15 . 
           [0027]      FIGS. 17-26  illustrate steps in a method of implanting a transport prosthesis in accordance with an embodiment described herein. 
           [0028]      FIG. 27  is a perspective view of a transport prosthesis according to another embodiment described herein. 
           [0029]      FIG. 28A  is a perspective view,  FIG. 28B  is a top view, and  FIG. 28C  is a cut-away perspective view of a transport ring. 
           [0030]      FIG. 29  is a side view of the transport prosthesis of  FIG. 27 . 
           [0031]      FIG. 30  is a perspective view of a saddle and sheath housing. 
       
    
    
     DETAILED DESCRIPTION 
       [0032]    Embodiments discussed herein provide techniques and apparatuses for promoting new bone growth and soft tissue by distraction osteogenesis in areas of the jaw bone and/or maxillofacial region. In the following description, numerous specific details are set forth, such as material types, dimensions, specific tissues, etc., in order to provide a thorough understanding of embodiments of the invention. Practitioners having ordinary skill in the biomedical arts will understand that embodiments of the invention may be practiced without many of these details. In other instances, well-known devices, methods, and biochemical processes have not been described in detail to avoid obscuring the invention. 
         [0033]    Embodiments discussed herein offer solutions to the foregoing problems by providing a transport prosthesis and distraction device that can regenerate new bone growth, reduce a patient&#39;s aesthetic concerns, protect a patient&#39;s biting surface, prevent multiple surgical procedures, enhance the structural integrity, and reduce bone deterioration of existing bone. The transport prosthesis and distraction device may be provided to dental practitioners as a complete, customized system for regenerating bone and soft tissue on a controlled vector thereby allowing for ideal aesthetic and prosthetic rehabilitation through optimal implant placement. The transport prosthesis and distraction device provides practitioners the capability to restore a patent from partial or complete edentulism without the need for bone harvesting from a donor site and without the need for a through and through osteotomy. 
         [0034]      FIG. 1  shows a top and back perspective view of a transport prosthesis  100  that is designed to be affixed to a patent&#39;s remaining teeth or jaw bone of the lower jaw, where the patient is in need of new bone growth on the jaw bone or within the maxillofacial region and/or one or more tooth implants.  FIG. 2  shows a top and side perspective view of the transport prosthesis  100 . 
         [0035]    The transport prosthesis  100  includes a number of prosthetic guide teeth  120   a - j . One or more, or all, of the guide teeth  120  may include a main aperture  130   a - j  arranged therein to allow access from the top of the prosthetic tooth to the bottom of the prosthetic tooth. The main aperture  130  may be used to provide access to the jaw bone such that a hole can be drilled and used to implant an implant fixture device or permanent prosthetic device, for example, a root of a permanent prosthetic tooth. As shown in  FIG. 1 , where a guide tooth  120   a - f  is wide enough, the main aperture  130   a - f  may be arranged through the guide tooth itself. Otherwise, where the guide tooth  120   g - j  is shaped as a veneer and is therefore too narrow to accommodate a main aperture, the main aperture  130   g - j  may be formed by a structure, e.g., a hoop, attached to and arranged behind the guide tooth. Although the embodiment shown in  FIG. 1  shows the main aperture  130   g - j  structure formed as a round hoop, it should be appreciated that other shapes could also be used, such as square, triangular, and other regular or irregular polyhedrons. 
         [0036]    The guide teeth  120  may also include one or more pairs of guide holes  132   a  and  132   b ,  132   c  and  132   d  which may be used to precisely locate a drill above the desired main aperture  130   b  or  130   e , respectively. For example, a drill (not shown), may include one or more protrusions that may be fit into the guide holes  132   a  and  132   b  to position the drill over the main aperture  130   b . The drill may then be used to drill into the bone underneath to create a hole for a permanent prosthetic while its position is maintained by the interlocking of the protrusions and the guide holes  132 . In the embodiment shown in  FIG. 1 , guide holes  132   a - d  are only provided for guide teeth  120   b  and  120   e . In other embodiments, guide holes  132  may be provided for only one guide tooth, more than one guide teeth, or all guide teeth. 
         [0037]    One or more of the guide teeth  120  may also have attached to them a device support  140 .  FIG. 3  shows a bottom view of device support  140   h  arranged on the transport prosthesis of  FIG. 1 . Device support  140   h  is used to support a distraction device  200  ( FIG. 7 ). As will be described in further detail below, an expansion component may be used to incrementally move a plate component of the distraction device. The device support  140   h  includes a ring  144  and optionally a number of protrusions  146  for supporting the expansion component  220 . While device support  140   h  shown in  FIGS. 1 ,  2 , and  3  is depicted as a ring, it should be understood that the device support  140   h  could be formed in other shapes, such as square, triangular, and other regular or irregular polyhedrons. In the embodiment shown in  FIGS. 1 and 2 , one device support  140   h  is used to support a distraction device that will be used to promote bone growth for the area under four different prosthetic teeth  120   g - j . In other embodiments, a device support  140   h  may be provided for a single tooth, two teeth, three teeth, five teeth, or more. 
         [0038]      FIG. 4  shows the transport prosthesis  100  of  FIG. 1  further including a number of covers  150   a - f  arranged on the prosthetic teeth  120   a - f . Covers  150   a - f , also shown in  FIG. 5 , are used to cap the guide teeth  120   a - f  and cover the main apertures  130   a - f  until they are needed. As shown in  FIG. 4 , covers  150   a - f  may be shaped as an uppermost portion of a tooth and may fit over the prosthetic teeth  130   a - f  to complete the top portion of a tooth shape. In one embodiment, covers  150   a - f  may attach to the prosthetic teeth  130   a - f  by snapping on and may be removed by snapping off or prying off. In another embodiment, covers  150   a - f  may be cemented into place. A number of the covers  150   b ,  150   e  may have a device support  140   b ,  140   e , respectively, arranged in the covers to support a distraction device. The device support  140   b ,  140   e  includes a through hole to allow a distraction device  200  to be arranged through the prosthetic teeth  120   b ,  120   e . Although the embodiment in  FIG. 4  shows only two caps having device supports, it should be understood that a lesser or greater number of caps could be provided with device supports. 
         [0039]    In one embodiment, where the patient is partially edentulous, the transport prosthesis  100  includes a number of caps  110   a ,  110   b ,  110   c ,  110   d ,  110   e ,  110   f , which are hollow teeth that may be shaped to conform to and fit over top of a patient&#39;s remaining teeth. It should be understood that the placement and shape of the caps  110  may be modified as needed to fit a patient&#39;s remaining teeth. Alternatively, if a patient is missing a tooth, but does not require bone growth or a prosthetic implant in the region of the missing tooth, the cap  110  overlying that area may be formed as a solid prosthetic tooth. In another embodiment, where the patient is completely edentulous, the caps may be omitted completely and all of the prosthetic teeth may be formed as drill guides. 
         [0040]    While the transport prosthesis  100  in the embodiment of  FIG. 1  is a full arch, it should be understood and appreciated that in other embodiments, the transport prosthesis may be formed as a partial arch. In another embodiment, the transport prosthesis could be in the form of a dental bridge, e.g., a resin-bonded bridge or Maryland bridge, and may be cemented into place in the gap between two remaining teeth. The application of a transport prosthesis in the form of a Maryland bridge enables a dentist to install the transport prosthesis with a minimum amount of tooth modification by cementing the transport prosthesis to acid etched enamel and an acid etched cast metal framework. The patient&#39;s abutment teeth may be left basically intact and undamaged. 
         [0041]    A bone distraction device  200  that may be mounted to the device support  140  is shown in  FIG. 6  and is further described in U.S. patent application Ser. Nos. 12/394,480 and 12/619,563, the disclosures of which are hereby incorporated by reference in their entirety. The bone distraction device  200  comprises a plate component  210  and an expansion component  220 . The plate component  210  has a plate  211  and a stem  212  (or apical portion) extending vertically from the plate  211 . In various embodiments, the stem  212  may be a threaded cylinder. The expansion component  220  (coronal portion) operatively connects and controls the retraction of the plate component  210 .  FIG. 9  shows a view of the bottom of a portion of the transport prosthetic  100  in which the plate component  110  has been inserted into the device support  140   h.    
         [0042]    The expansion component  210  may be retained in contact with the device support  140  by use of a washer  270 . The washer  270  may include an annular portion  276  and a number of retaining portions  272 . In use, the annular portion  276  may be arranged over and in contact with the expansion component  210  in such a way that the expansion component  210  may still rotate. The retaining portions  272  may be attached to the device support  140  by, for example, welding, adhesive, press fitting, melting, or other attachment methods. In one embodiment, the washer  270  may include two retaining portions  272 . In another embodiment, the retaining portions  272  may include a holes  274  that may match up with protrusions on the device support  140  to better hold the washer  270  in place. 
         [0043]    The plate component  210  and expansion component  220  can independently be formed of a material selected from one or more of the following materials: commercially pure titanium, titanium alloys, other metal alloys, or other metal substances. It should be noted that the metal substance should meet or exceed the parameters for materials used in dental implantology. It should be also appreciated that the plate and expansion components  210 ,  220  can be formed of a degradable or non-degradable bioceramic material, e.g., hydroxyapatite, reinforced polyethylene composite, betatricalciumphosphate, substituted calcium phosphates, bioactive glass, resorbable calcium phosphate, alumina, zirconia, etc. that may be manufactured as a solid structure. It should also be noted that a biodegradable polymer can be used in combination with the bioceramic material to form a composite material used to form the plate and expansion components  210 ,  220 . In the preferred embodiment, a hydroxyapatite material is utilized to form the plate and expansion components  210 ,  220 . The plate and expansion components  210 ,  220  can be formed by any type of material known in the art having characteristics that result in non-toxic byproducts. 
         [0044]    For example, plate and expansion components  210 ,  220  can be formed of synthetic polymers (alone or in combination) such as polyurethanes, polyorthoesters, polyvinyl alcohol, polyamides, polycarbonates, poly(ethylene)glycol, polylactic acid, polyglycolic acid, polycaprolactone, polyvinyl pyrrolidone, marine adhesive proteins, trimethylene carbonate, L-lactide, D,L-lactide, polyglycolide, and cyanoacrylates, or analogs, mixtures, combinations, and derivatives of the above. Plate and expansion components  210 ,  220  can also be formed of naturally occurring polymers or natively derived polymers (alone or in combination) such as agarose, alginate, fibrin, fibrinogen, fibronectin, collagen, gelatin, hyaluronic acid, and other suitable polymers and biopolymers, or analogs, mixtures, combinations, and derivatives of the above. Also, plate and expansion components  210 ,  220  can be formed from a mixture of naturally occurring biopolymers and synthetic polymers. Alternatively, plate and expansion components  210 ,  220  can be formed of a collagen gel, a polyvinyl alcohol sponge, a poly(D,L-lactide-co-glycolide) fiber matrix, a polyglactin fiber, a calcium alginate gel, a polyglycolic acid mesh, polyester (e.g., poly-(L-lactic acid) or a polyanhydride), a polysaccharide (e.g., alginate), polyphosphazene, or polyacrylate, or a polyethylene oxide-polypropylene glycol block copolymer. Plate and expansion components  210 ,  220  can be produced from proteins (e.g. extracellular matrix proteins such as fibrin, collagen, and fibronectin), polymers (e.g., polyvinylpyrrolidone), or hyaluronic acid. Synthetic polymers can also be used, including bioerodible polymers (e.g., poly(lactide), poly(glycolic acid), poly(lactide-co-glycolide), poly(caprolactone), polycarbonates, polyamides, polyanhydrides, polyamino acids, polyortho esters, polyacetals, polycyanoacrylates), degradable polyurethanes, non-erodible polymers (e.g., polyacrylates, ethylene-vinyl acetate polymers and other acyl substituted cellulose acetates and derivatives thereof), non-erodible polyurethanes, polystyrenes, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulphonated polyolifins, polyethylene oxide, polyvinyl alcohol, Teflon®, and nylon. 
         [0045]    Bioceramic materials employed as the manufacturing material can fall into all three biomaterial classifications, i.e., inert, resorbable and active, meaning they can either remain unchanged, dissolve or actively take part in physiological processes. There are several calcium phosphate ceramics that are considered biocompatible and possible materials for the plate component  210 . Of these, most are resorbable and will dissolve when exposed to physiological environments, e.g., the extracellular matrix. Some of these materials include, in order of solubility: Tetracalcium Phosphate (Ca 4 P 2 O 9 )&gt;Amorphous calcium Phosphate&gt;alpha-Tricalcium Phosphate (Ca 3 (PO 4 ) 2 )&gt;beta-Tricalcium Phosphate (Ca 3 (PO 4 )2)&gt;&gt;Hydroxyapatite (Ca 10 (PO 4 ) 6 (OH) 2 ). Unlike the other certain calcium phosphates listed above, hydroxyapatite does not break down under physiological conditions. In fact, it is thermodynamically stable at physiological pH and actively takes part in bone bonding, forming strong chemical bonds with surrounding bone. This property is advantageous for rapid bone repair after surgery. Other bioceramic materials such as Alumina and Zirconia are known for their general chemical inertness and hardness. These properties can be exploited for implant device support purposes, where it is used as an articulating surface for implant devices. Porous alumina can also be used as a bone spacer, where sections of bone have had to be removed due to various conditions or diseases. The material acts as an environment that promotes bone growth. 
         [0046]    At times, biodegradable polymers suffer from warping, hollowing or substantial erosion inherent with the process of degradation. In order to manage such a problem, polymers with high crystallinity are utilized. Self-reinforced and ultrahigh strength bioabsorbable composites are readily assembled from partially crystalline bioabsorbable polymers, like polyglycolides, polylactides and glycolide/lactide copolymers. These materials have high initial strength, appropriate modulus and strength retention time from 4 weeks up to 1 year in-vivo, depending on the implant geometry. Reinforcing elements such as fibers of crystalline polymers, fibers of carbon in polymeric resins, and particulate fillers, e.g., hydroxyapatite, may also be used to improve the dimensional stability and mechanical properties of biodegradable devices. The use of interpenetrating networks (IPN) in biodegradable material construction has been demonstrated as a means to improve mechanical strength. To further improve the mechanical properties of IPN-reinforced biodegradable materials, biodegradable plates may be prepared as semi-interpenetrating networks (SIPN) of crosslinked polypropylene fumarate within a host matrix of poly(lactide-co-glycolide) 85:15 (PLGA) or poly(1-lactide-co-d,l-lactide) 70:30 (PLA) using different crosslinking agents. 
         [0047]    Resin composites with incorporated polytetrafluoroethylene (PTFE) particles improve the hydrophobicity and surface properties of device implants, e.g., components  210 ,  220 . PTFE has high resistance to chemical regents, low surface energy, tolerance to low and high temperatures, resistance to weathering, low friction wiring, electrical insulation, and slipperiness. However, because conventional PTFE has poor resistance to abrasion, the inventor contemplates cross-linking PTFE with gamma-beam irradiation to drastically enhance resistance to abrasion and deformation. Further, the composites made of braided carbon fibers and epoxy resins (so called biocompatible carbon-epoxy resin) have better mechanical properties than composites made of short or laminated unidirectional fibers. 
         [0048]      FIG. 7  shows the plate component  210  and stem  212  of the distraction device  200  of  FIG. 6 . The stem  212  may be solid or may be hollow. If the stem  212  is hollow, fluids such as medicine or cells may be injected through the stem  212  to the patient&#39;s bone. The plate  211  of the plate component may be formed of a biocompatible and bioresorbable polymer as described in U.S. Pat. No. 6,607,548, the disclosure of which is hereby incorporated by reference in its entirety. The plate  211  may be solid or perforated. The polymer may be a melt-blended polymer composition including a base material including a biodegradable polymer or copolymer, and a copolymer additive including one or more monomers imparting a tensile strength for the implant at room temperature that is lower than a tensile strength at room temperature for an implant formed from the base material excluding the copolymer additive. In another embodiment, the polymer may be a melt-blended polymer composition including a base material including a biodegradable polymer or copolymer, and a copolymer additive including one or more monomers imparting a tensile strength for the melt-blended polymer composition at room temperature that is lower than a tensile strength at room temperature for the base material. 
         [0049]    To form the polymer, a biodegradable polymer or copolymer is provided as an initial base material and is then combined with one or more copolymer additives to alter the tensile properties of the biodegradable polymer or copolymer. The base material of the biodegradable polymer may be a polymer or copolymer of lactic acid, L-lactide, D-lactide, D,L-lactide, meso-lactide, glycolic acid, glycolide and the like and optionally other cyclic esters which are copolymerizable with lactide. Additional co-monomers may also be present to impart desired properties as needed such as alpha-, beta- or gamma-hydroxybutyric acid, alpha-, beta- or gamma-hydroxyvaleric acid and other hydroxy fatty acids (C 11  to C 25 ) such as stearic acid, palmitic acid, oleic acid, lauric acid and the like. Accordingly, the base material may include polylactides, polyglycolides, poly(L-lactide), poly (D-lactide), poly(L-lactide-co-D,L-lactide), poly(L-lactide-co-meso-lactide), poly(L-lactide-co-glycolide), poly(L-lactide-co-epsilon-caprolactone), poly(D,L-lactide-co-meso-lactide), poly(D,L-lactide-co-glycolide), poly(D,L-lactide-co-epsilon-caprolactone), poly(meso-lactide-co-glycolide), poly(meso-lactide-co-epsilon-caprolactone) and the like. When the base material is a copolymer, the monomer units may be present in a ratio of 50:50, 60:40, 70:30, 80:20, 85:15 and all suitable ratios in between. For example, suitable base materials include poly(L-lactide-co-D,L-lactide) 70:30, poly(L-lactide-co-D,L-lactide) 80:20, poly(L-lactide-co-glycolide) 85:15, and poly(L-lactide-co-glycolide) 80:20. Copolymers that contain L-lactide as a component preferably contain at least 70% of the L-lactide component and more preferably between about 70% and about 95% of the L-lactide component. Polymers or copolymers useful as base materials are commercially available from many sources or can be readily manufactured using methods well-known to those skilled in the art. 
         [0050]    The plate  211  may be formed by processing steps including injection molding, extrusion, pressure melting, hot pressing and other like methods known to those skilled in the art. In one embodiment, the polymer may be available to a dentist as a sheet of material. To form the plate  211 , the dentist may cut off an appropriate amount of the polymer from the sheet and bend and shape the polymer to conform to a patient&#39;s jaw bone. In various embodiments, the plate may be conformed to the patient&#39;s jaw bone as exactly as possible, or more generally, by creating a general shape thereof. In one embodiment, the polymer material may be softened by submerging the polymer in water, and then once malleable, the polymer material can be shaped, connected to the stem  212 , and allowed to harden. In another embodiment, the polymer material may be provided to the dentist in predetermined sizes and/or may include preformed holes for attaching the threaded cylinder portion  212 . 
         [0051]    The outer surface of both the plate and expansion components  210 ,  220  can be covered/roughened with a surface coating, for example, chitosan, for additional bone growth. The plate and expansion components  210 ,  220  having corresponding cylinder like portions (threaded cylinder portion  212  and hollow slot  225  (described below)), can be conventionally threaded (externally on the plate component  210  and internally on the expansion component  220 ) with clockwise or counterclockwise treads. The threads of the plate component  210  start about two (2) mm (for example) from the base of the plate component  210  and continue vertically along the entire length of the cylinder  212  of the plate component  210 . The threaded cylinder portion  212  may be rigidly attached to the plate component  211  by the use of threads or may be movably fitted to the plate component  211  by the use of a chamfered portion. 
         [0052]    As shown in  FIG. 6 , the expansion component  220  has a hollow slot  225  extending completely through, and within the full length, of the expansion component (completely from the top end  226  to the bottom end  227  of the expansion component  220 ) having threads. The hollow slot  225  has a cylindrical configuration and comprises internal clockwise or counterclockwise threads that correspond to respective threads on the cylinder  212  of the plate component  210 . The pitch of the threads on the plate and expansion components  210 ,  220  can be any pitch that promotes new bone growth of approximately 0.5 mm/day. Examples of a pitch that promotes new bone growth include, for example, 0.25 mm, 0.3 mm, 0.5 mm, 1.0 mm, 1.5 mm and 2.0 mm. The length of the expansion component  220  may vary depending on the required distraction; an example includes a length of the expansion component  220  of approximately 3.5 mm. 
         [0053]    In order to enable the surgeon or patient to easily read the distance of distraction after having activated the distraction expansion component  220  (as described below), the head of the expansion component  220  is preferably marked on the surface between the center and the side of the expansion component  220 . The mark may be an indentation in the expansion component  220  and/or may consist of a different color. 
         [0054]    The expansion component  220  may include interlacing or interlocking complimentary locking members  231  on the surface facing the device support  140  to interlock with the protrusions  146  of the device support  140  and prevent rotation of expansion component  220  during the transportation process. As described below, the expansion component  220  of the distraction device  200  provides for retraction between the plate and expansion components  210 ,  220  to form a distraction gap, between the plate component  210  and the patient&#39;s bone. In the embodiment shown in  FIG. 8 , the expansion component  220  may be replaced with a threaded nut  620  having a bottom end  627 , a top end  626 , and a hollow slot  625 . 
         [0055]    In one embodiment, the expansion component may be driven by the use of pneumatic or hydraulic pressure. For example, in order to operate the expansion component, a pneumatic or hydraulic source may be attached to the expansion component to adjust the expansion component with greater precision than might otherwise be obtained by hand. In another embodiment, a pneumatic or hydraulic source might be arranged to increase pressure under the plate component thus raising the plate component and the expansion component serving to hold the plate component in place after it is raised. 
         [0056]      FIG. 10  shows a transport prosthesis  600  affixed to a patent&#39;s remaining teeth and jaw bone  205  of the upper jaw, where the patient is in need of bone growth on the jaw bone or maxillofacial region and/or one or more tooth implants. Similar to the embodiment shown in  FIG. 1 , the transport prosthesis  300  includes a number of prosthetic guide teeth  320 , which may include a main aperture  330  arranged either within or behind the guide tooth. The main aperture  330  may be used to provide access to the jaw bone to drill a hole that will be used to implant an implant fixture device or permanent prosthetic device, for example, a root of a permanent prosthetic tooth. The transport prosthesis also includes a device support  340   a  for supporting a distraction device. 
         [0057]    In the embodiment shown in  FIG. 10 , each guide tooth  320  is provided with a pair of guide holes  332  which may be used to precisely locate a drill above the desired main aperture. A drill (not shown) that includes two protrusions may be fit into the guide holes  332  to position the drill over the main aperture  330 . The drill may then be used to drill into the bone underneath to create a hole for an implant fixture device or permanent prosthetic device, for example, a root of a permanent prosthetic tooth, while its position is maintained by the interlocking of the protrusions and the guide holes  332 . Where the guide tooth is a veneer too small to include a guide hole through the guide tooth, the guide holes may be formed as smaller hoops connected to the guide hoops. 
         [0058]      FIG. 11  shows a front and bottom perspective view of the prosthesis of  FIG. 10  and also shows an exploded view of the accompanying caps  350  and plate components  210   a - c .  FIG. 12  shows the transport prosthesis  300  of  FIG. 10  affixed to a jaw bone  205  and having the covers  350  arranged on the guide teeth  320 . The covers  350  are used to cap the guide teeth  320  and cover the main apertures  330  until they are needed. Similar to the covers  150  of the embodiment of  FIG. 4 , the covers  350  shown in  FIG. 12  may be contoured to fit over and complete the top portions of the prosthetic teeth  530  and the covers  350  may attach to the prosthetic teeth  330  by snapping or cementing on and may be removed by snapping off or prying off. The transport prosthesis of  FIG. 12  includes three separate device supports  340   a - c  to support the three plate components  210   a - c.    
         [0059]      FIG. 13  shows a front and bottom perspective view of a transport prosthesis  400  according to an embodiment in which the transport prosthesis  400  only includes a single device support  440 . The transport prosthesis  400  also includes a number of prosthetic guide teeth  420 , caps  410 , guide holes  432 , and main apertures  340 .  FIG. 14  shows the transport prosthesis  400  of  FIG. 13 , further including a cover  430 .  FIG. 15  shows a front and bottom perspective view of a transport prosthesis  400  according to an embodiment in which the transport prosthesis  500  only includes a single device support  540  and does not include any guide holes. The transport prosthesis  500  includes a number of prosthetic guide teeth  520  and caps  510 .  FIG. 16  shows the transport prosthesis  500  of  FIG. 15 , further including a cover  530 . 
         [0060]    An exemplary method of installing the transport prosthesis at a predetermined site or area  897  ( FIG. 18 ) where additional bone is required is described below. Prior to any surgical technique, proper treatment planning should be performed, including a physical examination, X-ray studies and consultation. Once the patient has been conventionally prepared for surgery, a local anesthetic is given and infiltrated into the surgical site. After allowing adequate time for anesthesia and vasoconstriction, a practitioner makes a crestal incision in the area of the defect using a scalpel  1701  or other instrument, as shown in  FIG. 17 , so that the full thickness buccal and lingual mucoperiosteal flaps  1801 ,  1802  are revealed, as shown in  FIG. 18 . The underlying bone of the alveolar ridge  1804  is conventionally exposed by, for example, raising the full thickness mucoperiosteal flaps with an elevator (not shown). The exposed bone  1804  may be conventionally evaluated by palpitation for bone density and quality. 
         [0061]    In one embodiment, the plate component  210  may be installed after the site  897  has suffered fresh trauma, such as where the tooth has been knocked out due to an accident or extracted from its bony socket. In another embodiment, the site  897  may be fully healed before the procedure to insert the plate component  210  is performed. Where the site is fully healed, one or more osteotomy cites  1903  may be created in the alveolar ridge  1804 , using a drill  1905  or other instrument, to create controlled micro-surgical trauma of the bone, as shown in  FIG. 19 . It should be noted that other conventional procedures could be used to create the osteotomy. All of the bone drilling procedures include copious amounts of irrigation, (internally and/or externally). The osteotomy site is enlarged by utilizing progressively wider drills. Optionally, the parallelism of the osteotomy site can be verified by X-rays and/or paralleling pins. The final sized osteotomy site is completed by either utilizing the final, smooth, twist drill or by tapping in the threads corresponding to the combination distraction dental implant.  FIG. 20  shows a number of osteotomy cites  1903  formed in the alveolar ridge  1804 . 
         [0062]    As shown in  FIG. 21 , the plate component  210  of the distraction device  200  is placed atop the osteotomy cites  1903  along the alveolar ridge  1904  where additional bone is required.  FIG. 22  shows an example of the plate component  210  arranged at a various sites  897  requiring bone growth in a partially edentulous patent. As shown in  FIG. 23 , primary wound closure may be effected using traditional surgical techniques, for example by sutures  2301 . In another embodiment, the plate component  210  may be omitted and the lifting of the tissue away from the osteotomy cites may be effected by the use of hydraulic, pneumatic, or mechanical means. For example, the tissue may be lifted away from the osteotomy cites by injecting fluid or air into a space between the osteotomy cites and the tissue. 
         [0063]    The plate  211  of the plate component  210  may be shaped to fit the predetermined site  897  prior to the surgery. As described above, in one embodiment, the plate  211  may be shaped off-site or may be cut and/or shaped by the dentist on-site. The plate component  210  is placed onto or into the bone  205  manually or by use of a conventional implant drill set at slow speeds, as is known by those skilled in the art. The wound is irrigated and, if osteotomies are formed, the incisions are conventionally closed with the threaded cylinder  212  being exposed. Intimacy of the plate component  210  into the bone is verified visually and tactilely. 
         [0064]    In one embodiment, in order to enhance the bone healing process during this procedure, bone growth factors such as bone morphogenetic proteins (BMPs) and basic fibroblast growth factor (bFGF) may be introduced to the area of distraction. These two classes of bone growth factors have been shown to accelerate bone regeneration, bone healing to prosthetic-like implants, and increase strength and stability to the bony callus. The bone growth factors could be delivered to the area of distraction by a variety of methods. One method would be to introduce the bone growth factors in combination with a collagen matrix, which could be a gel- or sponge-like material, to the area of distraction. The bone growth factor would stimulate the patient&#39;s own bone cells into action, while the collagen would provide the scaffolding into which the stimulated bone cells can grow. In the end, bone could replace the collagen scaffold, which may be eventually resorbed. Fibrinogen, a-thrombin, as well as other various antibiotics, growth hormones, gene therapies, or combinations of these factors may also be utilized in the distraction device  200  to promote healthy bone growth. The BMP material may be infused as a liquid or viscous gel substance. These cell therapies can be introduced to the bone site through a hollow transport pin. 
         [0065]    Another method of delivery could be to coat the actual distraction device  200  with the bone growth factor in combination with a bioceramic, such as hydroxyapatite or betatricalciumphosphate, which would have a synergic stimulative effect on the bone cells. For this to be accomplished, a specific amount of the bone growth factor would be absorbed to a gritblasted hydroxyapatite coated implant or distraction device prior to implantation. 
         [0066]    The transport prosthesis  300  may be formed prior to the surgery to closely conform to the patient&#39;s jaw and remaining teeth. A practitioner may capture data including images of the patient&#39;s jaw and/or remaining teeth by the use of a digital photograph, a conventional or cone-beam CT scan, a dental impression, a digital impression, or a combination thereof. The data may be imported to a data reader, for example, a DICOM medical data reader. Software may be used to design the transport prosthesis  300  to be used as part of a treatment plan that includes aesthetic consideration and tissue regeneration. The software may use various forms of complex analysis, including cephalometric analysis, to create a design for the transport prosthesis  300  that ensures ideal implant, abutment, and crown placement and to allow for advance planning of bone growth along a controlled vector. The various portions of the transport prosthesis may then be fabricated from the design using methods such as advanced direct digital manufacturing, CNC machining, robotics, and/or other various manufacturing steps commonly used to produce conventional dentures. The completed transport prosthesis may then be provided to the dental practitioner by itself, or as part of a kit that may include the transport prosthesis, a tool for adjusting the expansion component, such as those described in U.S. patent application Ser. No. 12/619,563, dental implants, and/or abutments and crowns. 
         [0067]      FIG. 24  is a view of a fully edentulous patient in the process of being fitted with the transport prosthesis  300 .  FIG. 25  is a front view and  FIG. 26  is a side view of a partially edentulous patient fitted with the transport prosthesis  300 . As shown in  FIGS. 24 ,  25 , and  26 , the transport prosthesis  300  is arranged over the plate component  210  of the distraction device  200  so that the threaded cylinder  212  extends through the support housing  340  ( FIG. 10 ). Where the patient is partially edentulous, the transport prosthesis  300  may be attached to the patient&#39;s remaining teeth by snapping on, any adhesive method known in the art, screws, or a combination thereof. If a patient is completely edentulous, the transport prosthesis  300  may be attached directly to the bone, for example, by dental fixation screws. 
         [0068]    The expansion component  220  may then be attached to the plate component  210 . The expansion component  220  must be rotatable around the plate component  210 , as will be discussed in detail below. As mentioned above, expansion component  220  has internal threads that can operatively engage with external threads of plate component  210  of the distraction device  200  during implantation. The expansion component  220  is rotated and thus must not be fixedly connected to the plate component  210  in such a way as to prevent the expansion component  220  from freely rotating around the plate component  210  as the plate component  210  rotationally raises from the patient&#39;s bone as the gap between the plate and expansion components  210 ,  220  is decreased axially during implantation by the interaction of the internal threads of the expansion component  220  with the external threads of the plate component  210 . Other conventional means for maintaining the rotatability of the expansion component  220  would be acceptable. 
         [0069]    The plate component  210  remains stationary in the bone and rotational movement of the expansion component  220 , provided by, such as for example, the interaction of the threads of the expansion component  220  with the external threads of the plate component  210 , provide for the retraction of the plate component  210  to the expansion component  220 . The body then attempts to heal itself by filling in the gap with new bone. If the gap is widened daily, the body recognizes the newly expanded gap and continues to fill the gap with new bone. By expanding the gap slowly over time (0.5-2.0 millimeters per day), the body will continue to heal the gap and generate new bone. Consequently, because the native bone is utilized as the template for repair, the new bone generated will comprise the same size, shape, density, and other characteristics as the original bone. Such results are advantageous and unique to new bone generation and are not accomplished when using other conventional bone transplantation techniques. Furthermore, during distraction osteogenesis, in addition to creating new bone, the overlying soft tissues are regenerated, a secondary gain unique to distraction osteogenesis. This secondary beneficial effect has significant clinical implications, for not only is the underlying foundation properly established, but also the overlying soft tissue is recreated providing for aesthetic and functional rehabilitation of the defect. 
         [0070]    The top surface  280  of the expansion component  220  has a hexagonal shaped aperture  290 . The aperture  290  provides the mechanical access to rotate the expansion component  220  to activate the distraction process via a corresponding hexagonal key. The hexagonal key may be made from stainless steel, and causes retraction of the plate and expansion components  210 ,  220  of the distraction device  200  during operation, as will be described more fully below. 
         [0071]    The patient is then educated as to the care and activation of the distraction device  200 . After allowing for a period of initial healing, a latency period (of about 5-7 days), the expansion component  220  is activated or maneuvered, (turned) thereby retracting the plate component  210  to the expansion component  220  (about 1.0 mm per day) in divided doses, and thus creating a distraction gap above the bone. The patient is also educated to make the adjustment necessary to increase or widen the gap each day. Thereafter, the patient is seen for follow-up and evaluation as appropriate. Since the typical height of a natural tooth crown above the gum is about eight (8) mm, in order to properly function, the distal end of the expansion component  220  should not extend above the level of the lowest adjacent tooth crown. 
         [0072]    After sufficient bone height (about 5 mm to about 15 mm) is achieved, the distraction process is halted. In one embodiment, the transport prosthesis  300  and expansion component  220  are removed. In another embodiment, the transport prosthesis is left in place and a drill is aligned with the main aperture  330  of a guide tooth using the guide holes  332 . The drill is used to form a hole in the newly grown bone to affix a more permanent prosthetic tooth. In one embodiment, because the newly grown bone may be relatively weak and incompletely ossified, a period of about four to about six weeks is required before the installation of the final prosthesis. 
         [0073]    The foregoing description illustrated one specific application of the technique and technology of distraction osteogenesis to the field of dental implants using an exemplary transport prosthesis, distraction device, and method. Since conventional dental implants have similar basic forms, it should be apparent to those skilled in the art that the potential combinations and rearrangements of the various features of the transport prosthesis and distraction device are unlimited. 
         [0074]    Advantages of embodiments described herein include providing new bone growth and soft tissue formation, thereby, reducing the number and morbidity of surgical procedures a patient is subjected to during the distraction as compared to the prior surgical procedures. Additionally, the transport prosthesis and distraction device described above provides for increased versatility by using an expansion component  220  to continuously adjust the distraction gap during the bone regeneration process without additional surgical procedures. The embodiments of the transport prosthetic and distraction device are also more aesthetically pleasing during the actual distraction process as compared to conventional devices and methods. It should also be appreciated to those skilled in the art that the above concept of a transport prosthetic and distraction device is not limited to use as a dental implant and could be used as a general distraction device in the maxillofacial region. 
         [0075]      FIG. 27  shows another embodiment of a transport prosthesis  500 . The transport prosthesis  500  includes a plate  510  having a hole  512 . The hole  112  is arranged to slide over a sheath housing  514 . The plate  510  is raised along the sheath housing by a transport ring  516 . The plate  510  can be metallic, ceramic, or a polymer. Furthermore, the plate  510  can be biodegradable and may be solid or perforated. 
         [0076]      FIG. 28A  shows a perspective view of the transport ring  516  and  FIG. 28B  shows a top view of the transport ring  516 .  FIG. 28C  shows a cut-away view of the transport ring  516  taken along line AA, as shown in  FIG. 28B . The transport ring  516  includes three arms  518 . The arms  518  have internal threads  520  arranged on their ends. The transport ring arms  518  are designed to follow along the slots  522  to the base  524  of the sheath housing  514 . The sheath housing  514  allows for transport of the distraction plate  510  and transport ring  516 . The sheath housing  514  also holds the activation screw  526 . The sheath housing  514  consists of a hollow tube with three slots  522  of equal size along its length at 120 degree intervals. At the base  524  of the sheath housing  514  can be either a drill  528 , as shown in  FIG. 27 , or a saddle  530 , as shown in  FIG. 30 , for fixation into the bone. 
         [0077]    The activation screw  526  allows for movement of the transport ring  516 . The activation screw  526  sets within the sheath housing  514 . To operate, the sheath housing  514  is fixed into the bone  532  ( FIG. 29 ), either by the drill  528  or saddle  530 . The drill  528  may be drilled into the bone  532  to fix the sheath housing  514 . As shown in  FIG. 30 , the saddle  530  may be attached to the bone  532  by a number of screws  534 . The transport ring  516  is slid along the sheath housing  514  to its base  524 . The plate  510  is set along the sheath housing  514  to the base  524  as well. The activation screw  526  is screwed into the sheath housing  514 . As shown in  FIG. 29 , once the activation screw  526  has reached the base  524  of the sheath housing  514 , the transport ring  516  will rise and push the distraction plate  510  along with it, for example, from point B to point C of  FIG. 29 . 
         [0078]    Changes and modifications in the specifically described embodiments and methods can be carried out without departing from the scope of the invention which is intended to be limited only by the scope of the appended claims.