Patent Publication Number: US-6911046-B2

Title: Biocompatible form and method of fabrication

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This is a division of U.S. patent application Ser. No. 10/012,652 filed Oct. 30, 2001 now U.S. Pat. No. 6,645,250 and entitled “Biocompatible Form and Method of Fabrication”. U.S. patent application Ser. No. 10/012,652 is hereby expressly incorporated by reference herein in its entirety. 
    
    
     STATEMENT RE FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not Applicable. 
     REFERENCE TO A “MICROFICHE APPENDIX” 
     Not Applicable. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates generally to bone implants and, more particularly, to biocompatible forms for use in supporting bone graft material. 
     2. Description of the Art 
     When a person experiences a loss of teeth due to trauma or other circumstances, or has teeth with periodontal disease, there is often a loss of interproximal crestal alveolar bone. This bone loss may also result in the loss of a person&#39;s interproximal or papillary oral tissue between the corresponding teeth and may cause a bone defect that is very unappealing aesthetically, and difficult to restore. The greater the atrophy of this alveolar bone, in either the maxilla or mandible, the less predictable the regeneration of this bone will be using current grafting procedures and associated structures, including those which are either permanently or temporarily implanted. Without the proper regeneration of this bone defect, any replacement tooth is likely to be mal-positioned, out of proportion and shape and form and lack interproximal tissue for a natural appearance. 
     The loss of teeth or periodontal disease may also result in the loss of root prominence alveolar bone, in either the maxilla or mandible. In the case of the mandible, the loss of teeth or periodontal disease may also result in a loss of mylohyoid ridge bone on either one or both sides of the mandible. Loss of root prominence alveolar bone or mylohyoid ridge bone further complicates the ability of the dentist to properly regenerate the lost bone and makes it more likely that the artificial tooth will be improperly positioned since the corresponding dental implant or support structure is supported by the root prominence bone and, depending on the particular tooth, may also be supported by the mylohyoid ridge bone. 
     Many attempts have been made to regenerate normal bone height and contours ranging from block grafts of bone, to grafts supported by screws or other metal supports. Known conventional graft techniques have failed to regenerate bone contours predictably and often result in placing grafted bone in locations where it is not needed, or regenerate bone that is over or under contoured. This often causes the patient to have multiple tissue and bone surgeries to correct the contours of the first graft. 
     One of the main goals in any attempt to replace a missing tooth is to position the tooth so that it will restore the natural appearances of the surrounding support bone and tissue. However, with the lack of bone in the atrophied maxilla or mandible, these criteria are impossible to accomplish and the results are poor with known techniques and devices. In these cases the dentist is required to restore the missing teeth and tissue contours with an artificial prosthesis, which replaces bone and soft tissue and tooth structure and may be supported by implants. The tissue and the tooth position are corrected by the prosthesis and not by the bone graft. No existing grafting technique attempts to restore the important interproximal scalloped bone contours that are critical to the proper placement of dental implants and aesthetics. One of the main problems associated with conventional methods for replacing teeth with implants is the creation of a “black hole” defect between teeth. This results from the lack of bone and tissue between the restored teeth and is very unnatural and is not aesthetically appealing to the patient. 
     Additional problems exist with known techniques associated with dental implants and bone grafts. For instance, dental implants are often placed in available bone or grafted bone that may not be in the proper position where teeth should be placed. The proper placement may actually be outside the dimensions of the bone. In these cases, if implants are placed in this bone, the dentist is forced to use advanced prosthetic techniques, such as angled abutments, longer transcutaneous abutments and/or custom cast abutments and frameworks to place a crown on an implant in an unnatural position. Usually, the defect is so great that the only prosthesis that can be used is the implant-supported denture, which artificially restores bone, tissue and tooth structure for the patient. 
     In view of the foregoing deficiencies associated with known devices and methods for regenerating dental bone in order to replace missing teeth, there remains a need for a biocompatible form and associated method for use in supporting bone graft material so that missing alveolar bone is restored to its natural contours thereby permitting dental implants to be placed in the exact position where the missing teeth were originally positioned in the skeletal bone, and allowing missing teeth to be replaced in their natural position. 
     BRIEF SUMMARY OF THE INVENTION 
     In view of the foregoing needs, the present invention is directed to a biocompatible form, which may be permanently implanted in a patient&#39;s oral cavity for use in supporting bone graft material, and a method of fabricating the biocompatible form. The biocompatible form may be advantageously utilized in either intraosseous or subperiosteal applications and the configuration of the various embodiments of the biocompatible form permit the regeneration of the scalloped alveolar bone to normal skeletal contours, for either the maxilla or mandible, thereby permitting the restoration of missing teeth in their correct position. More particularly, the biocompatible form of the present invention permits the regeneration of normal interproximal bone and tissue for an aesthetic appearance, thereby avoiding the “black hole” problems associated with conventional bone grafting techniques. Additionally, the biocompatible form permits the regeneration of root prominence root bone contours and mylohyoid ridge bone contours which contribute to the proper placement of the replacement teeth. The various configurations of the biocompatible form of the present invention permit a dentist to accurately place the bone graft material and add structural support during healing to reproduce the alveolar bone contours required to place the replacement teeth and the associated implants in the correct position. 
     According to a first aspect of the present invention, a biocompatible form is provided which may be permanently implanted in a patient&#39;s oral cavity for use in supporting bone graft material. The biocompatible form of the present invention is configured such that one or more portions conform to various alveolar bone contours. For instance, at least a portion of the biocompatible form may be configured to conform substantially to a predetermined, human interproximal bone contour, a root prominence bone contour, a palatal contour, a mylohyoid ridge bone contour, a maxillary facial contour, a maxillary lingual contour, a mandibular facial contour or a mandibular lingual contour. 
     According to a preferred embodiment, the biocompatible form is made of a first side portion, a second side portion and a connecting portion extending between and interconnecting the first and second side portions. The biocompatible form is open opposite the connecting portion and further includes open ends. 
     The first and second side portions and the connecting portion combine to define an interior channel, with the interior channel being sized and configured to receive at least a portion of an edentulous ridge of the patient and at least a portion of the bone graft material therewithin. The connecting portion of the biocompatible form includes at least one protruding portion, with each of the protruding portions being configured to conform substantially to a predetermined, human interproximal bone contour. The first side portion, second side portion and connecting portion are made of a biocompatible mesh. In one embodiment, the biocompatible form is a metal mesh, which may be fabricated from titanium or a titanium alloy and, in another embodiment, the biocompatible form is a fiber mesh, which may be fabricated from collagen. 
     In another embodiment, the biocompatible form can be configured to receive at least one dental prosthesis therethrough, with the biocompatible form further made of at least one aperture formed in the connecting portion of the biocompatible form and with each aperture sized to receive one of the dental prostheses therethrough. Each aperture is positioned intermediate an adjacent pair of the protruding portions. 
     In another embodiment, the first side portion of the biocompatible form may include at least one outwardly protruding portion, with each of these portions being configured to conform substantially to a predetermined human root prominence bone contour. In this embodiment, the second side portion may include at least one outwardly protruding portion, with each of the outwardly protruding portions being configured to conform substantially to a human root prominence bone contour, and with each of the outwardly protruding portions of the second side portion being aligned with one of the outwardly protruding portions of the first side portion. 
     In those embodiments where the first and second side portions of the biocompatible form include at least one outwardly protruding portion conforming substantially to predetermined human root prominence bone contours, each of the apertures is aligned with an aligned pair of the protruding portions of the first and second side portions, which permits each dental prosthesis to be implanted in an area of regenerated root prominence bone. 
     In yet another embodiment, having an application for regenerating the alveolar bone of a patient&#39;s mandible, the channel is sized and configure to receive a portion of a predetermined mandibular edentulous ridge. The second side portion may include at least one outwardly protruding each outwardly protruding of these portions being configured to conform substantially to a predetermined, human mylohyoid ridge bone contour. 
     In yet another embodiment, where the edentulous ridge of the patient is a maxillary ridge, the biocompatible form may further include a palatal portion integral with and extending away from the second side portion. The palatal portion being configured to conform substantially to a predetermined, human palatal bone contour. 
     The biocompatible mesh includes a first surface facing toward the interior channel of the biocompatible form and a second surface facing away from the interior channel. In those embodiments where the metal mesh is fabricated from either titanium or a titanium alloy, the first surface of the mesh may be sand-blasted and subsequently acid-etched to enhance adherence of the bone graph material to the biocompatible form. This applies to bone implants having either intraosseous or subperiosteal applications. Additionally, in intraosseous applications, the second surface of the mesh screen may also be sand-blasted and subsequently acid-etched to enhance the adherence of the bone graft material to the bone implant. With regard to subperiosteal applications, the second surface of the mesh may be polished to enhance adherence of the patient&#39;s oral mucosal tissue to the biocompatible form. Additionally, in these embodiments, the second surface of the mesh may be treated with titanium nitrate after the surface is polished for aesthetic purposes. 
     According to a second aspect of the present invention, a method is provided for fabricating a bone implant which may be permanently implanted in a patient&#39;s oral cavity for use in supporting bone graft material. According to one preferred embodiment, the method comprises the steps of acquiring a biocompatible mesh, creating a solid cast mold of an edentulous mandibular or maxillary ridge of a human cadaver skull which includes normal alveolar bone contours, and forming the biocompatible mesh to substantially conform to the contours of the solid cast mold including the contours of the mold corresponding to the normal alveolar bone contours of the human cadaver skull. 
     The step of forming may involve the step of press fitting the biocompatible mesh to the solid cast mold. The step of acquiring may include the step of selecting the biocompatible mesh from one of titanium, a titanium alloy and a fiber material. 
     The method of the present invention may be used to fabricate a biocompatible form having application as either an intraosseous implant or a subperiosteal implant. With either application, when the biocompatible mesh is made of either titanium or a titanium alloy, the method of the present invention may further include the steps of sandblasting a first surface of the biocompatible mesh which faces an interior channel defined by the mesh, and subsequently acid-etching the first surface of the mesh after the step of sandblasting, to enhance the adherence of the bone graft material to the biocompatible form. For biocompatible forms having intraosseous application, the method of the present invention may further include the steps of sandblasting a second surface of the biocompatible mesh which faces away from the interior channel, and acid-etching the second surface of the mesh after the step of sandblasting, also for the purpose of enhancing the adherence of the bone graft material to the biocompatible form. 
     In the instances where the biocompatible form is to be used for subperiosteal applications, the method of the present invention may further include the step of polishing the second surface of the biocompatible mesh to enhance adherence of the patient&#39;s oral mucosal tissue to the implant. In this embodiment, the method of the present invention may further include the step of treating the second surface of the biocompatible mesh with titanium nitrate, for aesthetic purposes. 
     According to another aspect of the invention, the biocompatible form can be customized to further conform to at least a portion of the alveolar bone contours of the patient&#39;s edentulous ridge. This method includes the steps of taking a CAT Scan of at least one of a patient&#39;s maxillary or mandibular ridge, which comprises an edentulous ridge, and fabricating a resin mold of the patient&#39;s edentulous ridge from an output of the CAT Scan. 
     The method of the present invention may also further involve the steps of taking an impression of a dental arch of the patient which is disposed in opposing relationship with the edentulous ridge of the patient and making a dental stone mold of the patient&#39;s dental arch. In this embodiment, the method further involves the steps of mounting the resin mold of the patient&#39;s edentulous ridge and the dental stone mold of the patient&#39;s opposing dental arch on a dental articulator, with the resin mold including an area corresponding to one or more missing teeth, and occluding a coronal portion of at least one tooth to the dental mold in a position opposite the area of missing teeth on the resin mold. 
     The method may further include the steps of positioning the formed biocompatible mesh on the resin mold over the area corresponding to one or more missing teeth and closing the dental articulator such that the dental stone mold is disposed in close proximity to the resin mold and the mesh screen. 
     According to another aspect of this invention, an intraosseous dental implant which is permanently implanted in a patient&#39;s oral cavity is provided. This dental implant is made of a membrane barrier layer, a bone graft material and a biocompatible form. This implant involves the membrane barrier layer substantially covering the bone graft material, the membrane barrier layer contacting a patient&#39;s oral mucosal tissue; the bone graft material substantially covering a biocompatible form, the biocompatible form having a first side portion, a second side portion and a connecting portion extending between and interconnecting the first and second side portions, the biocompatible form being open opposite the connecting portion and further including open ends, the first and second side portions and the connecting portion combining to define an interior channel, the interior channel being sized and configured to receive at least a portion of an edentulous ridge of the patient and at least a portion of the bone graft material therewithin; and the connecting portion including at least one protruding portion being configured to conform substantially to a predetermined, human interproximal bone contour; and at least a portion of the bone graft material disposed therewith the biocompatible form. 
     According to another aspect of this invention, a subperiosteal dental implant which is permanently implanted in a patient&#39;s oral cavity is provided. This dental implant is made of a membrane barrier layer, bone graft material and a biocompatible form. This implant involves the membrane barrier layer substantially covering the biocompatible form, the membrane barrier layer contacting a patient&#39;s oral mucosal tissue; the biocompatible form comprising a first side portion, a second side portion and a connecting portion extending between and interconnecting the first and second side portions, the biocompatible form being open opposite the connecting portion and further including open ends, the first and second side portions and the connecting portion combining to define an interior channel, the interior channel being sized and configured to receive at least a portion of an edentulous ridge of the patient and at least a portion of the bone graft material therewithin, the connecting portion including at least one protruding portion being configured to conform substantially to a predetermined, human interproximal bone contour, and at least a portion of the bone graft material disposed therewith the biocompatible form. 
     According to another aspect of this invention, an intraosseous dental implant which is permanently implanted in a patient&#39;s oral cavity is provided. This dental implant is made of a membrane barrier layer, bone graft material and a biocompatible form. This implant involves the membrane barrier layer substantially covering the bone graft material, the membrane barrier layer contacting a patient&#39;s oral mucosal tissue; the bone graft material substantially covering a biocompatible form comprising a first side portion, a second side portion and a connecting portion extending between and interconnecting the first and second side portions, the biocompatible form being open opposite the connecting portion and further including open ends, the first and second side portions and the connecting portion combining to define an interior channel, the channel being sized and configured to receive at least a portion of an edentulous ridge of the patient and at least a portion of the bone graft material therewithin; the first side portion including at least one outwardly protruding portion, each the outwardly protruding portion being configured to conform substantially to a predetermined, human root prominence bone contour; the second side portion includes at least one outwardly protruding portion, each the outwardly protruding portion being configured to conform substantially to a predetermined, human root prominence bone contour; and the first side portion, the second side portion and the connecting portion being made of a biocompatible mesh; and at least a portion of bone graft material disposed therewith the biocompatible form. 
     According to another aspect of this invention, a subperiostial dental implant which is permanently implanted in a patient&#39;s oral cavity is provided. This dental implant is made of a membrane barrier layer, bone graft material and a biocompatible form. This implant involves the membrane barrier layer substantially covering a biocompatible form, the membrane barrier layer contacting a patient&#39;s oral mucosal tissue, the biocompatible form comprising a first side portion, a second side portion and a connecting portion extending between and interconnecting the first and second side portions, the biocompatible form being open opposite the connecting portion and further including open ends, the first and second side portions and the connecting portion combining to define an interior channel, the channel being sized and configured to receive at least a portion of an edentulous ridge of the patient and at least a portion of the bone graft material therewithin; the first side portion including at least one outwardly protruding portion, each the outwardly protruding portion being configured to conform substantially to a predetermined, human root prominence bone contour; the second side portion includes at least one outwardly protruding portion, each the outwardly protruding portion being configured to conform substantially to a predetermined, human root prominence bone contour; and the first side portion, the second side portion and the connecting portion being made of a biocompatible mesh; and at least a portion of bone graft material being disposed therewithin the biocompatible form. 
     Another aspect of this invention provides a surgical kit including a sterilizable container adapted to contain articles. This kit can include a biocompatible form which may be permanently implanted in a patient&#39;s oral cavity for use in supporting bone graft material; the biocompatible form includes a first side portion, a second side portion and a connecting portion extending between and interconnecting the first and second side portions, the biocompatible form being open opposite the connecting portion and further including open ends, the first and second side portions and the connecting portion combining to define an interior channel, the interior channel being sized and configured to receive at least a portion of an edentulous ridge of the patient and at least a portion of the bone graft material therewithin; the connecting portion including at least one protruding portion, each of the protruding portion being configured to conform substantially to a predetermined, human interproximal bone contour or portions thereof. The kit further includes a plurality of devices adapted to attach the biocompatible form to a patient&#39;s edentulous ridge and dental tools, such as a pair of molding pliers and a pair of scissors. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other features, aspects and advantages of the present invention will become better understood with regard to the following description, appended claims and accompanying drawings, wherein: 
         FIG. 1  is a front elevation view of upper “maxillary” arch of human skull with several teeth missing; 
         FIG. 2  is a cross-sectional view taken along line  2 — 2  in FIG.  1 . 
         FIG. 3  is a cross-sectional view taken along line  3 — 3  in FIG.  1 . 
         FIG. 4  is cross-sectional view taken along line  4 — 4  in FIG.  1 . 
         FIG. 5  is a front elevation view similar to  FIG. 1 , but with bone loss shown due to missing teeth. 
         FIG. 6  is a front elevation view of bottom “mandibular” arch of human skull with several teeth missing; 
         FIG. 7  is a rear elevation view of the arch shown in  FIG. 6 , for the purpose of illustrating the mylohyoid ridge which appears on either side of the arch; 
         FIG. 8  is a perspective view of first embodiment of the biocompatible form of the present invention corresponding to a full upper “maxillary” dental arch; 
         FIG. 9  is another perspective view of first embodiment of the biocompatible form of the present invention corresponding to a full upper “maxillary” dental arch; 
         FIG. 10  is a top plan view of first embodiment of biocompatible form shown in  FIG. 8 ; 
         FIG. 11  is a front elevation view of first embodiment shown in  FIG. 8 ; 
         FIG. 12  is a rear elevation view of first embodiment shown in  FIG. 8 ; 
         FIG. 13  is a left side elevation of view of first embodiment shown in  FIG. 8 ; 
         FIG. 14  is a cross-sectional view taken along line  14 — 14  in  FIG. 11 ; 
         FIG. 15  is a cross-sectional view taken along line  15 — 15  in FIG.  11 . 
         FIG. 16  is a perspective view of second embodiment of biocompatible form of present invention, which includes a portion corresponding to the palate in the upper mouth. 
         FIG. 17  is a top plan view of embodiment shown in  FIG. 16 ; 
         FIG. 18  is a rear view further illustrating palatal area of the embodiment shown in  FIGS. 16 and 17 . 
         FIG. 19  is a perspective view of the third embodiment of present invention corresponding to upper, anterior quadrant portion of the biocompatible form. 
         FIG. 20  is a perspective view of fourth embodiment of biocompatible form of present invention corresponding to a customized left posterior quadrant of upper dental arch; 
         FIG. 21  is a perspective view of fifth embodiment of biocompatible form of present invention corresponding to an anterior quadrant of the upper dental arch; 
         FIG. 22  is a perspective view of sixth embodiment of biocompatible form of present invention corresponding to a full lower dental arch; 
         FIG. 23  is a fragmentary view of the embodiment shown in  FIG. 22 , to further illustrate the mylohyoid ridge bone contour. 
         FIG. 24  is a plan view of titanium mesh sheet; 
         FIG. 25  is a front elevation view of a dental articulator illustrating the following features: lower arch casting with full set of teeth; resin mold of upper dental arch, created from computer model and illustrating areas of missing teeth; crown portion bonded to corresponding lower teeth; mesh implant installed on upper arch, an illustration of bone graft material and portion of the articulator; 
         FIG. 26  is a front elevation view of a dental implant of the present invention. 
         FIG. 27  is a top view of dental implant shown in FIG.  26 . 
         FIG. 28  is a cross-sectional view taken along line  28 — 28  in FIG.  26 . 
         FIG. 29  is a front elevation view of another embodiment of a dental implant of the present invention. 
         FIG. 30  is a cross-sectional view taken along line  30 — 30  in FIG.  29 . 
         FIG. 31  is a plan view of a surgical kit made according to the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring now to the drawings, wherein like reference numerals have been used for similar elements throughout,  FIGS. 1-3  are views of an upper i.e., maxillary arch  10  of a human skull  12  which includes a plurality of teeth  14 . As shown in  FIG. 1 , the maxillary arch  10  is missing several teeth in the front, or anterior quadrant. The maxillary arch  10  further includes a plurality of circumferentially spaced interproximal bone contours  16  which are very important in positioning the teeth  14  in a vertical and horizontal direction. The plurality of interproximal bone contours  16  shown in  FIG. 1  in the anterior quadrant where the teeth are missing, are illustrated as representing human interproximal bone contours. A contour is a curving or an irregular feature such as the shape of the surface. For example, as shown in  FIGS. 2 and 3 , bones such as the interproximal bone  24  and the root prominence bone  26  form alveolar bone contours, such as an interproximal bone contour  16  and a root prominence bone contour  18 . 
     As may be further appreciated by reference to  FIG. 1 , the maxillary arch  10  includes a plurality of circumferentially spaced areas known as root prominence bone contours  18 . The root prominence bone contours  18  are formed by root prominence bones  26 . The plurality of root prominence bone contours  18  shown in  FIG. 1  are illustrated as representing human root prominence bone contours. A maxillary facial bone contour  20  includes a plurality of root prominence bone contours  18 , a plurality of the interstitial spaces  17  between root prominence bone contours  18 , and a plurality of interproximal bone contours  16  on the facial side of the jaw. Maxillary facial bone contour  20  is seen on a patient&#39;s face. 
       FIG. 2  is a cross-sectional view through the mid-line interproximal bone  24 . In  FIG. 2  the maxillary lingual bone contour  22  is shown. A maxillary lingual bone contour  22  includes a plurality of root prominence bone contours  18 , the interstitial space  17  between root prominence bone contours  18 , and a plurality of interproximal bone contours  16  on the lingual side of the jaw.  FIG. 3  is a cross-sectional view through the root prominence bone  26 . The maxillary lingual bone contours  22  is also shown in this view. 
     Now referring to  FIG. 4 , a horizontal cross section through the maxillary arch  10  is shown. The bone  28  covering the root of the tooth  14  is the bone-forming root prominence bone contour  18 . The plurality of root prominence bone contours  18  shown in  FIG. 1  are illustrated as representing normal human root prominence bone contours  18 . This figure also shows the maxillary lingual bone contour  22  and the maxillary facial bone contour  20 . It should be noted that the size and shape of the root prominence bone contour  18  varies depending on the size and shape of the root prominence bone  26 . 
     Now referring to  FIG. 5 , a front elevational view of an upper i.e. maxillary arch  10  of a human skull  12  is shown, in this view, the interproximal bone contour  16  and the root prominence bone contour  18  have been removed to simulate the loss of bone in this area as the result of trauma or atrophy. This area is known as the edentulous ridge  30 . 
       FIG. 6  is a front elevation view of a lower, i.e. a mandibular arch  32  of a human skull  12 , which includes a plurality of teeth  14 . As shown in  FIG. 6 , the mandibular arch  32  is missing several teeth in the front, or anterior quadrant. The mandibular arch  32  includes a plurality of circumferentially spaced interproximal bone contours  16  which are very important in positioning teeth in a vertical and horizontal direction. The particular interproximal bone contours  16  in the anterior quadrant where the teeth are missing are illustrated as representing human interproximal bone contours  16 . The mandibular arch  32  includes a plurality of circumferentially spaced areas known as root prominence bone contours  18 . A mandibular facial bone contour  23  includes a plurality of root prominence bone contours  18  a plurality of interstitial spaces  17  between root prominence bone contours  18 , and a plurality of interproximal bone contours  16  on the facial side of the jaw. 
     On the lingual side of the jaw as shown in  FIG. 7 , a plurality of mylohyoid ridge bone contours  38  are shown in FIG.  7 . The plurality of mylohyoid ridge bone contours  38  shown in  FIG. 7  illustrate normal human mylohyoid ridge bone contours  38 . Now referring to  FIG. 7 , a lingual view of  FIG. 6  is shown, including the mandibular lingual bone contour  34 . A lingual bone contour  34  includes a plurality of root prominence bone contours  18 , a plurality of interstitial spaces  17 , a plurality of interproximal bone contours  16  and a mylohyoid ridge bone contour  38  on the lingual side of the jaw. 
       FIGS. 8 and 9  are perspective views of one of the biocompatible forms of the present invention. The biocompatible form  40  is implanted into a patient to from a bone implant. This bone implant restores various alveolar bone contours and facilitates the implantation of a dental prosthesis. The biocompatible form  40  is filled with bone graft material to provide a bone implant. The bone graft material is placed inside of the biocompatible form  40  and then secured to an edentulous ridge  30  of the patient which corresponds to a full arch. A plurality of apertures  52  in the biocompatible form  40  are present to allow the placement of a dental prosthesis therethrough that would restore the actual tooth. More specifically, the biocompatible form  40  is made of a first side portion  42  (on the facial side), a second side portion  44  (on the lingual side), and a connecting portion  46  extending between and interconnecting the first  42  and second  44  side portions. The biocompatible form  40  is open opposite the connecting portion and further includes open ends  48 . The first side portion  42 , which corresponds to the facial side, the second side portion  44  which corresponds to the lingual side, and the connecting portion  46  define an interior channel  50 . The interior channel  50  is sized to receive a portion of the patient&#39;s edentulous ridge  30  and at least a portion of a bone graft material. 
     The biocompatible form  40  is configured such that one or more portions conform to various alveolar bone contours. For example, at least a portion of the biocompatible form may be configured to conform substantially to a predetermined human interproximal bone contour  16 , a root prominence bone contour  18 , a mylohyoid ridge bone contour  38 , a maxillary facial bone contour  20 , a mandibular facial bone contour  23 , a maxillary lingual bone contour  22  and a mandibular lingual bone contour  34 . 
     More specifically, each biocompatible form described in this invention includes at least one protruding portion  54 , each of the protruding portion  54  being configured to conform substantially to a predetermined human interproximal bone contour  16 . When multiple protruding portions  54  exist, each of the apertures  52  are positioned circumferentially intermediate an adjacent pair of the protruding portions  54 . The plurality of protruding portions  54  are circumferentially spaced from one another as shown in FIG.  9 . 
     The biocompatible form  40  further includes at least one aperture  52  formed in the connecting portion  46  of the biocompatible form  40  and with each aperture  52  sized to receive one of the dental prostheses therethrough. The aperture can have a variety of shapes, as they are sized to receive a dental prosthesis. When multiple protruding portions  54  exist, each of the apertures  52  is positioned circumferentially intermediate an adjacent pair of the protruding portions. The protruding portions being configured to conform substantially to a predetermined human interproximal bone contour  16 . 
     The biocompatible form  40  includes an outer surface  74  that faces away from channel  50  and an inner surface  76  that faces toward channel  50 . Depending on the application of the biocompatible form  40 , i.e. for use in an intraosseous implant or a subperiosteal implant, the outer surface  74  and inner surface  76  are treated differently. This method to make the biocompatible form  40  will be discussed in more detail in a later section. 
     Still referring to  FIG. 9 , this figure shows outwardly protruding portions  56  in the first side  42 , the facial side. Each of the outwardly protruding portions  56  conform substantially to a predetermined, human root prominence bone contour  18 . The term “predetermined” means that the contour of the biocompatible form is shaped to conform to a representative human skull from an adult male, adult female or a child. Now referring to  FIG. 10 , top plan view of a biocompatible form  40  is shown. This figure shows outwardly protruding portions  58  in the second side portion  44 , the lingual side. Each of the outwardly protruding portions  58  conforms substantially to a predetermined human root prominence bone contour  18 . Each of the outwardly protruding portions  58  of the second side portion  44  being aligned with one of the outwardly protruding portions  56  of the first side portion  42 . This alignment facilitates the proper alignment of the dental prosthesis. 
       FIG. 10  also shows apertures  52  formed in the connecting portion  46 . Each aperture  52  being sized to receive one of the dental prosthesis therethrough. Each aperture  52  being aligned with one of the outwardly protruding portions  56  of the first side portion  42  and aligned with one of the outwardly protruding portions  58  of the second side portion  44 . 
     Now referring to  FIG. 11 , a frontal view of the biocompatible form  40  is shown, including particularly the protruding portions  54  being configured to conform substantially to a predetermined, human interproximal bone contour  16 .  FIG. 11  also shows the first side portion  42  including a plurality of outwardly protruding portions  56 , each of the outwardly protruding portions being configured to conform substantially to a predetermined human root prominence bone  18  contour (shown in FIG.  2 ).  FIG. 11  also shows aperture  52 , sized to receive one of the dental prothesis therethrough. 
       FIG. 12  is a rear view of the biocompatible form  40 . This view shows the outwardly protruding portions  58  that conform substantially to a lingual contour  22  of a predetermined human root prominence bone  18  contour (shown in FIG.  1 ). 
       FIG. 13  is a left-sided, or left quadrant view of a biocompatible form.  FIG. 14  is a cross-sectional view of an anterior section going through the interproximal section of the biocompatible form  40  of  FIG. 8  at  14 — 14 .  FIG. 15  is a similar view going through the root prominence portion of  FIG. 8  at  15 — 15 . 
     In the embodiment, shown in  FIGS. 16-18 , a palatal section  61  of mesh is added to biocompatible form  40 , as described previously, to form a biocompatible form  60  useful in the reconstruction of palatal defects. More specifically, the biocompatible form  60  may further include a palatal portion  61  integral with and extending away from the second side portion  44 , i.e. the lingual side. The palatal portion  61  has an arcuate shape conforming substantially to a predetermined human palatal bone contour. In this embodiment, the second side portion  44  includes a proximal portion  63  integral with the connecting portion and a distal portion  65  opposite the proximal portion. The palatal portion  61  of the biocompatible form  60  is integral with the distal portion  65  of the second side portion  44 . 
     The biocompatible form  60  is configured such that one or more portions conform to various alveolar bone contours. For example, at least a portion of the biocompatible form may be configured to conform substantially to a predetermined human interproximal bone contour  16 , a root prominence bone contour  18 , a maxillary facial bone contour  20 , or a maxillary lingual bone contour  22 . 
     In yet another embodiment as shown in  FIGS. 22 and 23 , having an application for regenerating the alveolar bone of a patient&#39;s mandible, the second side portion  44  may include at least one outwardly protruding and circumferentially extending portion  38  with each of these portions being configured to conform substantially to a predetermined, human mylohyoid ridge bone contour  38 . The biocompatible form  70 , shown in  FIGS. 22 and 23 , is configured such that one or more portions conform to various alveolar bone contours. For example, at least a portion of the biocompatible form  70  may be configured to conform substantially to a predetermined human interproximal bone contour  16 , a root prominence bone contour  18  and a mylohyoid ridge bone contour  38 , a maxillary facial bone contour  20 , a mandibular facial bone contour  23 , a mandibular lingual bone tour  34  and a maxillary bone contour  22 . 
     In another embodiment of the invention, portions of the biocompatible form  40  and  70  are provided. In  FIG. 19 , for example, an anterior quadrant section of biocompatible form  64  is shown. More specifically, an anterior implant going from the right cuspid to the left cuspid area in a maxilla is shown. The quadrant section of the biocompatible form  64  includes on the first side portion  42  outwardly protruding portion  56 , on the second side portion  44 , outwardly protruding portion  58  (not shown) and protruding portion  54 . The outer surface  74  and inner surface  76  of the quadrant section of the biocompatible form  64  are also shown.  FIG. 20  is the side view on a left quadrant section  66  of a biocompatible form  40 .  FIG. 21  is a customized anterior implant  62  going from the right lateral incisor to the left lateral incisor, including both centrals. 
     The biocompatible forms  40 ,  60  and  70  are made of biocompatible metal mesh such as titanium and/or titanium alloy or stainless steel, or a fibrous mesh, such as a collagen mesh. An example of a sheet of mesh is shown in FIG.  24 . The mesh may also be formed from metal perforated with holes. The biocompatible form  40 ,  60  and  70  are pre-formed to the normal contours of the alveolar bone by press fitting the mesh to a titanium replica model of a normal edentulous ridge with alveolar bone contours. The titanium replica model is formed from an adult male, an adult female, or older child&#39;s skull. The biocompatible forms  40 ,  60  and  70  are configured to conform substantially to predetermined, human interproximal bone contours. 
     The biocompatible forms  40 ,  60  and  70  include a first facial side  42  and a second side lingual  44  connected by a connecting portion  46 . Each side has an outer surface  74  and an inner surface  76 . The outer surface  74  faces the facial or lingual side of the form and the inner surface  76  faces the interior channel  50 . In those embodiments where the biocompatible forms  40 ,  60  and  70  are made of a metal wire mesh screen fabricated from either titanium or a titanium alloy, the inner  76  surfaces of the mesh screen may be sandblasted and subsequently acid-etched to enhance adherence of the bone graft material to the biocompatible form  40 ,  60  and  70 . This applies to biocompatible forms  40  having either intraosseous or subperiosteal applications. Additionally, in intraosseous applications, the outer  74  surfaces of the biocompatible form  40 ,  60  and  70  may also be sandblasted and subsequently acid-etched, according to conventional procedures, to enhance the adherence of the bone graft material to the biocompatible form  40  and  70 . With regard to subperiosteal applications, the outer  74  surfaces of the biocompatible form  40  may be satin polished with a polishing wheel to enhance adherence of the patient&#39;s oral mucosal tissue to the dental implant. Additionally, in these embodiments, the outer  74  surfaces of the biocompatible form  40  may be treated with titanium nitrate after the surface is polished for aesthetic purposes to prevent a metal, such as titanium from showing through the tissue. 
     According to a second aspect of the present invention, a method is provided for fabricating biocompatible forms  40 ,  60  and  70 , which may be permanently implanted in a patient&#39;s oral cavity for use in supporting bone graft material. According to one preferred embodiment, the method involves the steps of acquiring a biocompatible screen, creating a solid cast mold of an edentulous mandibular or maxillary ridge of a human cadaver skull which includes normal alveolar bone contours, and forming the biocompatible screen to substantially conform to the contours of the solid cast mold including the contours of the mold corresponding to the normal alveolar bone contours of the human cadaver skull. The step of forming may involve the step of press fitting the biocompatible screen to the solid cast mold. The step of acquiring may involve the step of selecting the biocompatible mesh from one of titanium, a titanium alloy, wire mesh and a fiber mesh. 
       FIG. 25  is a representation of a technique for customizing the biocompatible form  40  to conform to at least a portion of the alveolar bone contours of a particular patient&#39;s edentulous ridge. First, an endentuolus ridge  30  is shown, next to the normal maxillary arch  10 , an area that represents the grafted bone material  80  is shown, and going further to the right, the biocompatible form  62  is shown. In this figure, the replacement of the missing teeth of the laterals and the centrals  82  are also shown. 
     More particularly, this method involves the steps of taking a CAT scan of at least one of a patient&#39;s maxillary or mandibular ridge, which includes an edentulous ridge  30 , and fabricating a resin mold  84  of the patient&#39;s edentulous ridge from an output of the CAT scan. The method of the present invention may also further involve the steps of taking an impression of a dental arch  86  of the patient which is disposed in opposing relationship with the edentulous ridge  30  of the patient and making a dental stone mold of the patient&#39;s dental arch  86 . In this embodiment, the method further involves the steps of mounting the resin mold  84  of the patient&#39;s edentulous ridge  30  and the dental stone mold of the patient&#39;s opposing dental arch on a dental articulator with the resin mold  84  including an area corresponding to one or more missing teeth, and occluding a coronal portion of at least one tooth  82  to the dental stone mold in a position opposite the area of missing teeth on the resin mold. A dental articulator is a device that can simulate movements of the jaw. This articulated relationship of the edentulous resin cast to the dental stone mold of the patients&#39; opposing dental arch allows for customization of the mesh to incorporate the unique contours, for example, of the interproximal bone contour, root prominence bone contour, and additionally palatal bone contour and mylohyoid bone contour. It also allows the surgeon to estimate the amount of bone graft material needed to regenerate the lost bone. 
     The method may further include the steps of positioning the modified biocompatible form  40 ,  60  or  70  on the resin mold over the area corresponding to one or more missing teeth and closing the articulator such that the dental stone mold  86  is disposed in close proximity to the resin mold  84  and the biocompatible form  40 ,  60  or  70 . The method may further include the step of customizing the biocompatible form  40  to further conform to at least a portion of the alveolar bone contours of the patient&#39;s edentulous ridge  30 . The biocompatible form  40 ,  60  and  70  may be further customized using dental tools such as pliers and scissors to fit a particular patient. 
     The method of the present invention may be used to fabricate a biocompatible form  40 ,  60  or  70  having application as either an intraosseous implant or a subperiosteal implant. The method of the present invention may further include the steps of sandblasting the interior channel  50  surfaces of the biocompatible form  40 ,  60  or  70 . This includes the inner surfaces  76  of the first side  42 , the second side  44  and the connecting portion  46 . These surfaces will be acid-etched to enhance the adherence of the bone graft material to the biocompatible form  40 ,  60  or  70 . For biocompatible forms  40 ,  60  or  70  having an intraosseous application, the method of the present invention may further include the steps of sandblasting the outer surfaces  74  of the first side facial portion  42 , the second side lingual portion  44  and the connecting portion  46 . This will also be acid-etched to enhance the adherence of the bone grafting material to the biocompatible form  40 ,  60  and  70 . 
     In the instances where the biocompatible forms  40 ,  60  and  70  is to be used for subperiosteal applications, the method of the present invention may further include the step of satin polishing the outer surfaces  74  of the biocompatible form  40  to enhance adherence of the patient&#39;s oral mucosal tissue to the implant. In this embodiment, the method of the present invention may further include the step of treating the second surface of the biocompatible forms  40 ,  60  and  70  with titanium nitrate, for aesthetic purposes. 
       FIGS. 26-27  is a graphic representation of a intraosseous bone implant  62  shown in FIG.  21 .  FIG. 26  shows the multiple layers for an intraosseous bone implant  62 . The outer layer being the oral mucosal tissue  102 . The oral mucosal tissue is retracted prior to inserting the intraosseous bone implant  62  and then re-applied to contact a membrane barrier layer  104 . A membrane barrier layer  104  acts as a barrier to tissue to prevent the tissue from obstructing bone healing. This membrane barrier layer  104  is typically absorbable and is preferably collagen. A variety of membrane barrier layers are used with bone implants and it is within the skills of the surgeon to select a suitable membrane barrier layer. The membrane barrier layer  104  in an intraosseous bone implant substantially covers the bone grafted material. 
     The next layer is the bone grafted material  80 , which is overlayed onto the biocompatible form  62  and substantially covers the biocompatible form  62 . The next layer is the biocompatible form  62 , and then the final layer is the grafted bone material  80  within the bone implant  62 . This figure also shows a plurality of the bone tacks  110  for holding the bone graft in place into the ridge. The bone tacks are titanium screws on tacks or a reabsorbable bone tack.  FIG. 28  is a cross-section view of FIG.  26 . It is a cross-sectional view through the interproximal bone  26  of the bone implant  62 . This figure also shows the residual edentulous ridge  30  within the bone implant  62 . More specifically in an intraosseous implant, a second layer of graft material  80  is applied over the bone implant  62 . The bone graft material is autogenous from patient&#39;s own bone, such as the hip or from surgical site, and/or allographic material from artificial bone, such as cadavers or animal bones, mixed with plasma proteins and normal saline, as known in dental arts. 
       FIG. 29  is a subperiostial implant. The difference between the subperiostial and the intraosseous bone implant is the overlay of the bony graft material on top of the bone implant  62  and the surface preparation of the bone implant. In a subperiostial implant, as shown in FIG.  29  and cross-section view  30 , a membrane barrier layer  104  substantially covers a customized biocompatible form  62 . The biocompatible form  62  contacts a layer of the patient&#39;s oral mucosal tissue  102 . The biocompatible form  62  is substantially filled with bone graft material  80 .  FIG. 30  also shows the edentulous ridge  30  within the biocompatible form  62 . 
       FIG. 31  is a representation of a surgical kit. The biocompatible forms included in surgical kit  90  can be for either an intraosseal or for subperiostial applications, depending on the treatment of the surface of the biocompatible form. Consequently, two types of surgical kits  90  are contemplated by this invention. More specifically, a customized biocompatible form  62  may be permanently implanted in a patient&#39;s oral cavity for use in supporting the bone graft material in a subperiosteal application. A biocompatible form for use in a subperiosteal application is made of a metal mesh. The metal mesh as formed into a biocompatible form includes a first surface facing toward the interior channel, and a second surface facing away from the interior channel. In a subperiosteal application, the second surface of the biocompatible form is polished to enhance adherence of the patient&#39;s oral mucosal tissue to the biocompatible form. 
     In an alternative embodiment of the kit, the kit  90  includes a biocompatible form treated for use in an intraosseous application. In a biocompatible form for use in an intraosseous application, all surfaces are sand blasted and subsequently acid etched to enhance the adherence of the bone graft material to the biocompatible form. 
     Each surgical kit, as shown in  FIG. 31 , may include biocompatible forms  40  and  70 , for a complete edentulous arch of the maxilla and mandible arch respectively. It may also include portions thereof of the complete arch such as anterior  64  and posterior quadrants  66  and  72  left and right of each arch. A biocompatible form  60  for the maxilla, which includes the palatal mesh, may also be included. A pair of titanium molding pliers  112  and scissors  113  are included in the surgical kit  90 . A plurality of devices, such as bone screws  110 , adapted to attach the biocompatible form to the residual ridge are also included. The surgical kit  90  is made of a sterilizable container adapted to contain various biocompatible forms, a pair of titanium molding pliers  112 , scissors,  113 , and a plurality of bone screws. The surgical kit  90  can be sterilized using a conventional means, such as ETO. 
     The biocompatible form is pre-formed to normal contours of the alveolar bone by press fitting the biocompatible forms  40 ,  60  or  70  to a titanium replica model of a normal endentulous ridge to replicate bone contours. The biocompatible form  40 ,  60  or  70  can be cut into arch quadrants and surfaces prepared. The biocompatible form  40 ,  60  or  70  prepared for intraosseous application is totally sand blasted with small particles of titanium and acid etched. The subperiosteal implants under surface is also sand blasted and acid etched and the tissue surfaces are satin polished. The biocompatible forms  40 ,  60  and  70  can also be treated with titanium nitrate. They are sterilized and packaged. The biocompatible form  40  is made in various gauges and mesh sizes. 
     EXAMPLE 1—Intraosseous Implant 
     A patient with missing teeth requires restoration. A CAT scan of the area to be regenerated along with its surround arch form is performed. A computer-generated resin model of the existing bony contours and the remaining dental arch is fabricated. The model is mounted on articulator (Whipmix®, Lexington, Ky.) with the opposing arch. The missing teeth on the resin model are positioned in a normal anatomic position to determine the amount and contours of the bone to be regenerated. Wax or other medium is applied to the resin model to simulate the contours of the bone. The model is duplicated by conventional means. An intraosseous biocompatible form from the kit shown in  FIG. 31  is selected that matches the patient. A biocompatible form  40  or  70  for a complete edentulous arch of the maxilla or mandible arch respectively, can be used or a biocompatible form such as  62 , which is a portion of the full arch, can be used. The surgeon selects a biocompatible form that more closely matches the needed restoration. In this example, a biocompatible form  40 , corresponding to a full arch is cut to precise form with titanium scissors and place on the duplicated model. The mesh can be recontoured with molding pliers to exactly fit the model and the desired regenerated contours. The biocompatible form  40  is sterilized by conventional means and prepared for surgical placement. 
     At the time of surgery, the tissue is reflected and graft site prepared. The biocompatible form is filled with an autogenous and/or an allographic material such as Bio-Oss® Concellus or Bio-Oss® Contical (OsteoHealth Co., Shirley, N.Y.) and secured to prepared bony receptor site with reabsorbable fixation pins. In this case, an intraosseo implant, the biocompatible form is placed 1-2 mm below the actual regenerated contours to allow for placement of graph material over the top of the biocompatible form. An absorbable collagen membrane, such as Bio-Gide® (OsteoHealth, Co., Shirley, N.Y.) is placed over the intraosseo implant and tissue closed for primary healing. The graft site is allowed to heal for six months with no pressure on the graft area. After healing is completed, dental prosthesis may be placed in the apertures. 
     EXAMPLE 2—Subperiosteal Implant 
     A patient with missing teeth requires restoration. A CAT scan of the area to be regenerated along with its surround arch form is performed. A computer-generated resin model of the existing bony contours and the remaining dental arch is fabricated. The model is mounted on articulator (Whipmix®, Lexington, Ky.) with the opposing arch. The missing teeth on the resin model are positioned in a normal anatomic position to determine the amount and contours of the bone to be regenerated. Wax or other medium is applied to the resin model to simulate the contours of the bone. The model is duplicated by conventional means. A subperiosteal biocompatible form from the kit shown in  FIG. 31  is selected that matches the patient. The biocompatible form  40  is cut to precise form with titanium scissors and place on the duplicated model. The mesh can be recontoured with molding pliers to exactly fit the model and the desired regenerated contours. The biocompatible form  40  is sterilized by conventional means and prepared for surgical placement. 
     At the time of surgery, the tissue is reflected and grafted site prepared. The biocompatible form is filled with autogenous and/or allographic material such as Bio-Oss® Concellus or Bio-Oss® Conticol (OsteoHealth Co., Shirley, N.Y.) and secured to prepare bony receptor site with titanium screws or tacks. In a subperiosteal implant, a collagen membrane, such as Bio-Gide® (OsteoHealth Co., Shirley, N.Y.) is placed directly on the biocompatible form and the tissue closed for primary healing. The graft site should be allowed to heal for six months with no pressure on the graft area. After healing is complete, dental implants may be placed in the designed receptor sites. 
     EXAMPLE 3—Palatal Defect Restoration 
     If a patient is missing palatal bone and several teeth due to surgery from a cancerous tumor, the procedures set out in Example 1 or 2 are repeated, but with the exception of a biocompatible form  60  having palatal area  61  is selected from the surgical kit  90 . 
     While the foregoing description has set forth the various embodiments of the present invention in particular detail, it must be understood that numerous modifications, substitutions and changes can be undertaken without departing from the true spirit and scope of the present invention as defined by the ensuing claims. The invention is therefore not limited to specific preferred embodiments as described, but is only limited as defined by the following claims.