Patent Publication Number: US-2007105068-A1

Title: Combination distraction dental implant and method of use

Description:
This invention is a continuation-in-part of my prior patent application Ser. No. 08/886,078 filed Jul. 2, 1997 entitled Combination Distraction Dental Implant and Method of Use. That application which is reproduced in its entirety hereinafter is directed to an in situ combination distraction and dental implant system comprising an apical member having a top surface, a coronal member comprising internal threads and a bottom surface with the bottom surface of the coronal member facing the top surface of the apical member and a rod like connecting distraction member comprising a first set of external threads matingly engageable with the internal threads of the coronal member facilitating mechanical incremental rotation of the connection and distraction member with respect to the coronal member such that incremental rotation of the connecting and distraction member causes the coronal member to vertically separate from the apical member and create a correspondingly sized vertical gap between the top and bottom surfaces for distraction osteogenesis. 
    
    
      That system creates osteogenesis in the jaw of a dental patient by surgically cutting a section of the jaw so that the cut section attaches to the coronal member, and as the coronal member separates from the apical member, the jaw segment which has been sectioned slowly moves away from the remaining jaw section so that osteogenesis begins to occur filling the gap between the separated tissue members. The movable segmented jaw section generally moves upwardly to raise the bone and gum level line (for the bottom jaw) to enhance the support structure for a dental implant to be placed in the jaw of the dental patient. By allowing the jaw tissue of the jaw segment (which is movable with respect to the remainder of the jaw) to adhere to the coronal member and move the coronal member vertically, not rotationally, with respect to the distraction member, tissue tear between the movable jaw segment and the coronal member is materially eliminated.  
      The present invention recognizes that distraction osteogenesis may be generated more simply by merely providing a combination distraction and dental implant system in which the system only comprises a combination dental distraction and implant device which comprises a head and a shaft portion. The shaft, preferably basically cylindrical, comprises a threaded, longitudinal shank section and a smooth-wall distal-end section. The distraction and implant device is engaged in the jaw of the patient in a conventional manner, i.e., by first tapping and screw threading the member into an undercut bore drilled into the jaw. In order to provide distraction osteogenesis, the jaw is surgically cut as described in my prior patent application, and rather than there being separate coronal and apical members, this new invention comprises merely providing a unitary, combination distraction and dental implant device which comprises a head and shaft, with the shaft comprising a threaded, shank section and a smooth, distal wall portion.  
      After the jaw is surgically cut as described in my prior application and the combined dental implant/distractor of the present invention is inserted in the jaw in the conventional manner, distraction osteogenesis can be generated. This occurs because the smooth, distal end of the device bears against, for instance, a round section in the bone cut surface or a bottom, round jaw surface (an alternate embodiment provides a base support member, like a disc or washer). Thus, further turning of the combined dental implant/distractor cannot cause it to move further in a vertical direction. Rather, as the device is slowly rotated, jaw tissue in the jaw segment (grown toward and adhered to the distraction device) moves upwardly. In order to provide incremental upward movement for the segmented jaw section, the distraction device is rotated and the tissue which adhered to the distraction device separates therefrom. Because of the threaded surface of the upper shank section of the distraction device and the jaw tissue which bears thereagainst, rotation of the device (blocked from vertical movement) will cause the upper segment of the jaw to climb or glide up the inclined plane of the threads or lift upwardly because of the vertical/lifting pressure of the threads against the contiguous and adjoining jaw section segment.  
      In order to enhance the healing process, in quality and time, between the jaw tissue and the combined distraction/implant device, BMP or other bone growth enhancing material can be introduced. The growth enhancing substance can be applied directly through interior channels in the distraction device either by using a syringe placed downwardly in a throughhole to distribute the BMP radially throughout channels in the device or it may be directly applied to the interstices between the jaw tissue and the distraction device itself. By providing such augmenting tissue restorative material such as BMP, the process for causing distraction osteogenesis and bone healing to occur will be materially enhanced in time while reducing the trauma to the jaw tissue which provides bearing surfaces for the distraction device.  
      In another embodiment of this invention, a bottom plate or apical member, preferably a small disc, can be inserted in a drilled bore of the jaw prior to insertion of the combined distraction and implant device so as to provide a more effective bearing surface upon which the smooth distal end of the distraction device will rotate and bear. Such an apical member or thin metal plate could be made of a resorbable material such as PGA or PLA so that placement of the unitary implant and distraction device can be a one-time surgical activity in which the distraction device serves not only to create distraction osteogenesis, but it also serves as the support or implant securing mechanism for a later cap or crown (prosthesis).  
      The inventor&#39;s own prior, referred-to patent application (reproduced hereinafter) describes a system in which the implant is placed in the lower jaw, upper jaw or is placed in a jaw section (in the latter situation, an H cut is provided so to simultaneously allow the upper and lower jaw segments in a single jaw section to move opposite from each other). Distraction osteogenesis occurs because of their adherence of tissue to the apical and coronal members which move away from each other as the threaded distraction member rotates. In the present invention, separate coronal and apical members are no longer required because the distraction member, itself, is provided with threads in the region in which relative tissue movement is required for the sectioned jaw segment—whether two segments move opposite to each other, an upper segment moving upwardly towards the sinus or an upper segment in the lower jaw moves to raise the gum line.  
      The dental implant distraction device of this invention is physically identical, in one embodiment, to  FIGS. 8A and 8B  of my prior patent application. The device comprises a biocompatible material and is sized to be inserted into the jaw of a patient. Thus, for the patent claims directed solely to the new embodiment of the device itself,  FIGS. 8A and 8B  of my prior application provide support for the claims and the filing date of the earlier application shall apply to claims reading upon the device depicted in  FIGS. 8A and 8B .  
      This invention is directed to both an apparatus and the method of creating distraction osteogenesis by providing a simple single mechanical unit, a combination dental implant-distraction device which is capable of creating distraction osteogenesis and providing a support for a conventional implant, crown or prosthesis.  
     BRIEF DESCRIPTION OF THE DRAWINGS  
      The numbering of the Figures in this patent application will commence with  FIG. 14  as  FIGS. 1 through 13  are taken from my prior patent application which is reproduced in its entirety hereinafter and incorporated expressly herein. For purposes of ease of reference:  
       FIG. 14  is a perspective view showing the integral, combination dental implant-distraction device of this invention which is also shown in  FIGS. 8A and 8B  of the prior application;  
       FIG. 15  is a perspective view similar to  FIG. 14  showing a base, disc-like member or flat, apical member upon which the smooth-walled and smooth end, distal portion of the dental implant-distraction device bears during its rotation, thereby providing distraction osteogenesis;  
       FIGS. 14 and 15  show the position of the dental implant prior to the surgical cut in the bone creating the jaw surgical section segment which moves relative to the remainder of the jaw section; the surgical cuts were described in my prior patent application.  
       FIG. 16  is an enlarged, partial, sectional view of the threaded portion of the dental implant-distraction device and the jaw tissue growing proximate thereto, which, in combination allows the jaw segment to be moved upwardly as the distraction device incrementally rotates and the threads of the device provide lifting and inclined support for the jaw tissue thereby moving the jaw tissue upwardly when the device is incrementally rotated;  
       FIG. 17  illustrates another embodiment of this invention in which a covering cap for the dental implant-distractor device is provided for improved hygienics. This embodiment shows a combination dental implant-distraction device with a plurality of internal pathways outwardly or radially emanating from a center bore, extending through the dental implant-distraction device to enhance distribution of BMP, introduced through the top bore, which enhances tissue restoration and bone growth; and  
       FIG. 18  is an alternative embodiment of this invention in which a center section of the dental implant distraction device is smooth and the longitudinally extended segments are both threaded thereby allowing for concurrent movement of both upper and lower jaw segments with respect to each other by those jaw segments bearing against the upper and lower threaded sections of the dental implant-distraction device. This device could be used to promote, for example, distraction osteogenesis in an upper jaw in two directions, i.e., moving bone growth toward the sinus area and moving the gum line to align with adjacent teeth and gum structure.  
       FIG. 19  is a perspective view of an alternate embodiment of a final connecting member, consistent with the invention fully disclosed in my prior application; and  
       FIG. 20  is a perspective view of an alternate embodiment of a combination dental implant and distraction member with a coronal member, extra-osseously located.  
      Prior Patent application Ser. No. 09/886,078  
      The following section repeats and corresponds to the specification (written description and drawings  FIGS. 1-13 , including the Abstract of the Disclosure) of my prior patent application Ser. No. 08/886,078 filed Jul. 2, 1997. To the extent not exactly repeated herein, it is expressly incorporated herein by reference. Minor changes may have been made for clarity and ease of reading.  
      The present invention relates generally to dental implant systems and methods for replacing missing teeth with dental implants, more particularly, to dental implant systems and surgical methods for replacing teeth with dental implants in areas of the mouth that have suffered bone loss and most particularly to combination distraction dental implant devices and methods for replacing missing teeth in areas of the jaw bone having bone loss using a three component combination distraction dental implant device including two cylindrical like components and a connecting third component or an expansion third component to grow new bone and soft tissue by distraction osteogenesis;  
      Premature tooth loss can limit a patient&#39;s ability to chew and speak clearly. Consequently, patients request tooth replacement. In the past, dentists have been able to replace missing teeth by means of removable prosthesis such as partial or complete dentures. Other prior alternatives included the placement of fixed bridge work cemented to adjacent teeth. These two prior methods served only to fill the void of the edentulous space by replacing the crown of the involved teeth but did not replace the root.  
      Recently, the field of dental implantology has come into its own, as the technology for replacement of the root and the crown portion of the missing teeth has evolved. In dental implantology, the root portion of the missing tooth is replaced first, by surgically implanting a cylindrical root form dental implant into the dentoalveolar bone (Stage I). There are a number of U.S. Patents relating to dental implants, including the following: U.S. Pat. Nos. 5,489,210; 5,470,230; 5,449,291; 5,334,024; 5,281,140; 5,269,685; 5,259,759; 5,154,612; 5,145,371; 5,125,841; 5,069,622; 5,064,425; 5,051,880; 4,960,381; 4,824,372; 4,798,205; 4,682,951; 4,657,510; 4,552,532 and 4,330,891 the disclosure of each is herein incorporated by reference.  
      As the surgical site heals, the dental implant becomes bonded and incorporated into the surrounding bone forming an integral unit. The dental implant abutment for the creation of the crown of the tooth later, once osseous healing had occurred (4-6 months), is placed at the time of Stage II uncovering.  
      In some instances, the above is accomplished by a one-stage implant procedure. In the one-stage procedure, also known as the nonsubmerged, either a one-piece fixture, in which the implant and transmucosal portion are fused together, or both an implant body and a healing cap are simultaneously placed. Instead of covering the implant, the soft tissue is sutured around the protruding transmucosal portion or healing cap and left to heal for the same 4 to 6 months. The advantages of one-stage implants is described in detail in an article by Louis F. Clarizio, DDS, entitled “One-stage Implants: An Overview of Their Usefulness and the Techniques for Placement” in the  Postgraduate Dentistry Series,  Volume 3, Number 4, 1996 beginning at page 3, the disclosure of which is hereby incorporated by reference.  
      Regardless of whether a one-stage or a two-stage implant is used, long term success of dental implants depends upon two factors: (1) the osseous incorporation or integration of the implant with the native bone, and (2) the mechanical loading properties of the prosthetic crown onto the dental implant. Ideally, the longest (13-15 mm) and widest (2.5-5.5 mm) dental implant should be placed in the bone to act as a proper foundation for the tooth crown.  
      However, as a consequence of premature tooth loss, patients have lost bone in the area of a proposed implant. This bone loss has, in some cases, limited the surgical options, requiring the dentist to place a smaller than optimal sized dental implant. If the dental implant is too small to accommodate the mechanical load from chewing, with time, it will loosen and fail. Thus, the longest and widest implant available, as described above, (based on the bone stock) should be placed. Additionally, due to bone loss or insufficient bone in the implant area, the dental implant may be placed in an anatomical location where the existing bone may not be ideal for prosthetic reconstruction with a crown or bridge, forcing the dentist to replace the missing tooth with a crown that is not as aesthetic or functional as would be considered optimal.  
      One prior solution to this bone loss problem was to augment the bony bed with the patient&#39;s own bone or cadaveric bone as a transplant, or with synthetic bone substitutes. This procedure was done at the time of dental implant placement if the bone loss is not too great. Otherwise 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 was completed.  
      Due to the anatomy of the craniofacial region (defined as pertaining to the region of the head which contains the craniofacial bones, including the maxilla, the upper jaw bone includes the bones of the eyes, the hard palate and the nose, and the mandible, the lower jaw bone, usually with reference to specialized surgical or prosthetic reconstructions of this area of the face), augmentation of the deficient bone is not as simple as layering on the transplanted bone and allowing it to heal. Occasionally, the maxillary sinus membrane (located in the upper jaw) must be elevated or the inferior alveolar nerve (located in the lower jaw) transposed to allow room for placement of the bone graft. Regardless of the technique and materials used, the potential morbidity to the patient can be significant.  
      Another prior technique of producing new bone was that of distraction osteogenesis. Here, the body was “tricked” into making new bone as it attempts to heal a fracture site. Using this technique, the surgeon created an osteotomy or cut in the bone in an area of bone deficiency. As long as a non-critical size gap exists, the body 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. This results in creation of new bone in the expansion gap. As long as the gap is expanded slowly over time (0.5-2.0 millimeters per day), the body continues to heal the gap, generating new bone.  
      A critical size defect is one that will not heal on its own i.e. a critical size defect is sufficiently large to allow only for connective tissue healing without bone bridging between the two ends of the defect. A non critical defect is one which will heal on its own by filling in with bone. Each bone of the body has its own “critical size” defect. If a critical size defect exists, then a bone graft or a bone substitute must be placed to allow for osseous regeneration.  
      Since the native bone is utilized as the template for repair, the new bone generated has the same size and shape as the original bone. This phenomenon of recreating the same size and shape as the original bone is unique to bone generation using distraction osteogenesis and is not accomplished with conventional bone transplantation.  
      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.  
      Distraction osteogenesis defined as the generation of new bone in response to the application of tension stresses placed across an osteotomy site (bone cut site), has been successfully applied to the bones of the maxillofacial region and specifically to the dentoalveolar unit using distraction devices that are external to at least the gums inside the mouth and, in some cases, completely external the mouth. In these prior instances of applying distraction osteogenesis prior to placing a dental implant, an osteotomy (corticotomy) is made in the bone adjacent to the area requiring bone augmentation and one of the prior bone expansion devices was applied. After allowing for a period of initial healing, the prior device was activated by the patient at home, advancing the distraction gap about 0.5 to about 2.0 millimeters a day. For a more complete description of distraction osteogenesis, see the article “Osteodistraction” by the inventor of the present application in  Selected Readings in Oral and Maxillofacial Surgery,  volume 4, Number 7, published by the University of Texas, Southwestern Medical Center at Dallas, in 1996, the disclosure of which is herein incorporated by reference.  
      After a sufficient amount of new bone matrix was generated, the distraction device was left in place to allow for ossification of the newly generated bone. The prior distraction devices were then removed during a second surgical procedure and dental implant(s) are placed. Once again the patient was required to undergo two surgical procedures: (1) bone generation via distraction osteogenesis and (2) placement of the dental implant.  
      A minimum of about ten (10) to about fifteen (15) millimeters of bone was required to utilize the existing distraction devices. If there was not enough bone stock to place the existing devices, a bone graft was required prior to the distraction device being placed. In this case, the patient was required to undergo three separate surgical procedures.  
      The current external and submerged distraction devices are also limited in the amount of bone expansion each device can deliver because they have fixed internal mechanisms which provide for bone expansion from 0.0 mm to the full length specified for a particular device. Presently, for an external distraction device the full length is about 40 mm while for an intraoral distraction device, the full length is about 18 to about 20 mm. Should more bone expansion be required, then a new device was required to be placed during yet another surgical procedure (fourth).  
      These prior distraction devices took essentially two approaches: (1) the device was situated externally, outside the skin, with pins holding the device in place to the bone, or (2) the device was situated intraorally, inside the mouth, along the gum line, with pins or screws holding the device in place. Devices which are located externally function well but can pose aesthetic concerns while the patient is utilizing the device and also facial scars are created as the pins holding the device in place are moved as the device is activated and the bone is expanded. Intraoral devices do not have as many aesthetic concerns, but are bulky, displacing the lips and cheeks, which can give the patient the appearance of a local infection.  
      As can be seen above, in the worst case, some patients were required to undergo as many as four (4) separate surgical procedures over a lengthy time period in order to achieve an optimal dental implant. It should be obvious that it is desirable to limit the number of surgical procedure a patient must undergo.  
      Thus, there is a need for new devices and methods for placing optimally sized dental implants in areas having insufficient bone. Such new devices and methods should reduce the number of surgical procedures a patient must undergo to achieve an optimal implant; should significantly reduce the number of individual distraction devices required for obtaining the appropriate amount of bone in the implant site; should reduce the number of surgical procedures required for placing an optimal implant in the implant site; should incorporate as many features of the prior devices as possible into a combination distraction dental implant device; should reduce patients aesthetic concerns; should reduce, if not totally eliminate, displaced lips and cheeks and should reduce, if not totally eliminate, the need for bone grafts.  
     SUMMARY OF THE INVENTION  
      It is accordingly one object of the present application to provide a new combination dental implant and distraction device and method of using which limits the number of surgical procedures a patient must undergo to have an optimum dental implant placed in an area having initially insufficient bone stock.  
      Another object of the present invention is to provide a combination distraction dental implant device and method of using the device that combines the technology of dental implantology and that of distraction osteogenesis such that a combination distraction dental implant can be utilized as both the bone distraction device and, after the distraction, left in place as the dental implant.  
      A still further object of the invention is to provide a combination distraction dental implant device that is utilized as the root form for a prosthesis such as, for example, a crown, a bridge or dentures.  
      Another object of the invention is to provide a combination distraction dental implant that eliminates the need for the complete removal of the distraction device prior to placement of a separate dental implant during another surgical procedure.  
      A further object of the present invention is to provide a combination distraction dental implant that eliminates the need for bone grafts in areas of limited bone stock in order to place optimal dental implants.  
      Another object of the invention is to provide a combination distraction dental implant that lifts the sinus during the distraction process.  
      The above and other objects of the present invention are realized by combining the technology of dental implantology and that of distraction osteogenesis to produce a combination distraction dental implant which serves as both the implant and the distraction device. In preferred embodiments and methods of the present invention, a combination distraction dental implant is utilized as both the distraction or bone expansion device and the dental implant device and is left in place after distraction in the place of the prior conventional dental implant.  
      One representative embodiment of a specific 
      combination distraction dental implant comprises: a hollow coronal component; a partially hollow apical component initially having at least one surface contiguous with at least one surface of the hollow coronal component; and at least one expansion component for: (a) operatively connecting the hollow coronal component and the partially hollow apical component, and     (b) controllably expanding the distance between the contiguous surfaces of the hollow coronal component and the partially hollow apical component to form a gap.    

      Another representative embodiment of a specific combination distraction dental implant for placing an optimum dental implant in an area having initially insufficient bone stock comprises: a hollow coronal component; a partially hollow apical component operatively positioned proximal the hollow coronal component; and a removable connecting component operatively connecting the hollow coronal component and the partially hollow apical component.  
      One representative method of the present invention includes the steps of: providing a three component distraction device including a hollow coronal component, a partially hollow apical component and a linking component or a first expansion component; placing the combination distraction device in a predetermined site where bone regeneration is required; allowing the combination distraction device to become integrated into the bone; ensuring that osseous incorporation of the combination distraction device into the bone has been accomplished; performing a corticotomy in the buccal bone at the level of the contiguous surfaces of two of the three components of the combination distraction device to form a distraction gap; educating the patient as to the care and activation of the three component combination distraction device; after allowing for a period of initial healing, maneuvering the connecting component thereby separating the coronal component and the apical component to widen the distraction gap in the bone.  
      Another representative embodiment of a more general purpose distraction device of the present invention includes: a first component selectively operatively removably connectable to a first predetermined portion of a bone; a second component selectively operatively removably connectable to a second predetermined portion of the bone, the second component being operatively positioned proximal the first component; and a connecting component for: (a) operatively connecting the first and the second components, and (b) controllably expanding the distance between the first and the second components.  
      Other objects and advantages of the present application will become apparent from the following description, the accompanying drawings and the appended claims. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       FIG. 1  is an exploded view of a representative prior conventional dental implant with the implant shown placed in the upper jaw bone;  
       FIG. 2  is an exploded view a representative combination distraction dental implant of the present invention with parts shown in phantom;  
       FIG. 3  is an exploded cross-sectional view of the representative combination distraction dental implant of  FIG. 2 ;  
       FIG. 4  is a perspective view of the representative combination distraction dental implant of the present invention shown after initial placement in an area of the jaw requiring additional bone;  
       FIG. 5  is a perspective view of the representative combination distraction dental implant of  FIG. 4  shown after initial placement in an area of the jaw requiring additional bone and after some bone has be generated;  
       FIG. 6  is a perspective view of the representative combination distraction dental implant of  FIG. 4  shown after initial placement in an area of the jaw requiring additional bone and after additional bone has be generated;  
       FIG. 7  is a perspective view of the representative combination distraction dental implant of  FIG. 5  shown after sufficient bone has be generated to support an optimum crown;  
       FIG. 8A  is a perspective view of one representative expansion component of a plurality of different size expansion components usable with the combination distraction dental implant of the present invention;  
       FIG. 8B  is a perspective view of another representative expansion component of a plurality of different size expansion components usable with the combination distraction dental implant of the present invention;  
       FIG. 8C  is a perspective view of a representative abutment usable with the combination distraction dental implant of the present invention;  
       FIG. 9  is a schematic view of a maxillary sinus in an area of the jaw having diminished bone height requiring additional bone prior to the placement of an implant;  
       FIG. 10  is a schematic view of the representative combination distraction dental implant of the present invention shown after initial placement in an area of the jaw requiring additional bone;  
       FIG. 11  is a schematic view of the representative combination distraction dental implant of  FIG. 10  shown after initial placement in an area of the jaw requiring additional bone and after some bone has been generated lifting the maxillary sinus;  
       FIG. 12  is a schematic view of the representative combination distraction dental implant of  FIG. 11  shown after additional bone has been generated further lifting the maxillary sinus; and  
       FIG. 13  is a schematic view of a representative combination distraction dental implant of  FIG. 11  shown after sufficient bone has been generated to support an optimum crown and even further lifting the maxillary sinus. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
      The science and technology of dental implants have been described above. As such, dental implants have evolved from a simple cylindrical form to now having external threads, self tapping grooves, vertical grooves, vents, apical holes and treads, and surface coatings/treatments (titanium plasma spray, acid-etch, hydroxylapatite, microspheres, sintered pores, bone promoting substances, selective surface combinations), etc., all of which act to serve as mechanisms to facilitate placement and promote bone healing, thus increasing retention of the implant within the bone. As is known, dental implants can be made of various grades of titanium (Grade I-IV) to increase the strength of the implant itself. Implants may also be stepped or tapered apically, allowing for placement into narrow anatomical spaces. Implants may have a smooth collar to provide for cervical healing. Implants may have external or internal hexagonal, octagonal, spline and other designs to allow for increased retention and anti-rotation, friction-fit/interference-fit of the prosthesis such as, for example, a crown, a bridge or dentures onto the implant.  
      Regardless of the specific manufactures design, a dental implant serves to replace the missing root shape of the tooth, utilizing the best mechanical form available for that manufacture&#39;s design. Ultimately the design of any dental implant is dictated by its clinical success. Consequently, variations in the basic design of root form dental implants is limited.  
       FIG. 1  illustrates a representative conventional dental implant. This conventional dental implant  20  comprises a cylinder like member  22  having internal threads (not shown) for receiving a post  26  which supports a dental prosthesis such as, for example, a crown  28 , a bridge or dentures. The cylinder like member comprises a neck portion  30  for connection with the post  26 , a body portion  32  and an apex portion  34 .  
      In one exemplary embodiment of the present invention, the three component combination distraction dental implant device includes a two component externally smooth or threaded, stepped or tapered portion with round ends made of, such as, for example, implant grades of titanium or other material that performs effectively in implant usage. The external surface of the, presently preferably cylinder like, combination distraction dental implant may be smooth, roughened or coated with bone augmentation materials (hydroxyapatite, bone morphogenic proteins, titanium plasma spray, microspheres, sintered pores, selective surface combinations, etc.). The cylinder like portion of the combination distraction dental implant is separated horizontally, dividing the cylinder like portion of the combination distraction dental implant into two components, an apical component and a coronal component. The apical component of the implant may be modified to contain through and through ports, such as, for example, in a x-fashion or a y-fashion port configuration or two (2) holes through and through to allow for osseous incorporation. The apical and the coronal components, presently preferably, contain internal threads, or equivalent structure, into which a connecting component or an expansion component is operatively placed. The internal structure of the apical and the coronal components are adapted to operatively cooperate with the expansion component such that (1) at a minimum, the two components are operatively connected together and (2) the distance between the apical component and the coronal component is selectively varied.  
      When initially used, the connecting component is advanced into the two separable apical and coronal components by rotating, for example, the connecting component in a clockwise direction. As the connecting component is advanced into the coronal component and then into the apical component of the combination distraction dental implant, the body of the connecting component cooperates with the internal structure of the coronal component and one end of the connecting component operatively engages the internal structure of the apical component and effectively connects the two components together.  
      When the two components having the initial connecting component operatively positioned therein have become sufficiently integrated with the bone, the initial connecting component is removed and replaced with a first expansion component for causing separation between the apical and coronal components thereby expanding a surgically created distraction gap in the bone. Since, when properly placed in a patient&#39;s bone, the apical and coronal components become integrated, fused intra-osseously to the bone, separating these two components expands the distraction gap previously made in the bone proximal to the separation point between the two components. The separation of the components is dependent upon the cuts in the bone. If the bone is cut perpendicular to the horizontal cut in both directions, then the components will move apart, as in a sinus lift. If the bone is cut perpendicular to the horizontal cut in only one direction, then only the component most proximal the perpendicular cuts will move.  
      Both the initial connecting component and the expansion component are designed to be removable from a position connecting the apical and the coronal components, such as, for example, by reversing the direction of rotation. Once removed, the expansion component may be replaced with a longer expansion component, allowing for incremental distraction osteogenesis, or by an abutment for receiving a crown, once sufficient bone has been regenerated to support an optimal implant.  
      In any event, any one of the plurality of possible sized expansion components are operative to both connect and controllably separate the two separable components of the combination distraction dental implant and provides for the controllable separation of the separable apical and the coronal components during the distraction process. Upon completion of the distraction, the expansion component is replaced by the abutment which becomes incorporated into the bone during healing.  
      In one representative surgical approach, the combination distraction dental implant device is placed by making an incision along the crest of dental ridge exposing the underlying bone. Using sequentially sized drills, an osteotomy is created in the planned implant placement site. The osteotomy is sized such that the cylindrical distraction implant will fit with a friction fit. A tap drill may also be utilized to tap the bone site to receive the threaded type of distraction implant. The appropriately sized three component combination distraction dental implant is then placed and the incision is closed, with either the top of the initial connecting component extending through the soft tissue or covered by the soft tissue, the cap being flush with the surface of the bone. The combination distraction dental implant is then allowed to heal and become integrated into the bone.  
      If a two-stage implant procedure was determined appropriate, during Phase II, uncovering, the buccal portion of the bone is exposed. Next in both the one-stage and the two-stage procedures, osseous integration of the combination distraction dental implant is verified visually, tactilely and radiographically, as appropriate. In one presently preferred method, using radiographs, a corticotomy is created in the buccal bone at the level of the combination distraction dental implant separation site i.e., the position where the apical component and the coronal component are contiguous. The buccal cortex is scored/cut at the same horizontal level. Two vertical bicortical osteotomies are then created at the limit of the edentulous space, the area to be expanded. The incision is closed with the initial distraction connecting or expansion component extending intra-orally. After a latency period and after replacing the initial connecting component, if used, with an expansion component, the distraction expansion component is activated separating the distraction gap, i.e. the gap between the apical component and the coronal component. After adequate bone height is achieved, the last of the plurality of possible sized expansion components is removed and replaced with an abutment which acts as the basis for a prosthesis such as, for example, a crown, a bridge or dentures.  
      In one specific method of the present invention, the bone site for the combination distraction dental implant is created and the three component combination distraction dental implant placed. After the combination distraction dental implant has integrated into the bone, the distraction implant is surgically approached. A bone cut is made at the level of the planned distraction gap. The new bone cut is allowed a period of initial healing, and the distraction process is then initiated. This distraction activation can be coupled with (Stage  11 ) uncovering of three component dental implant. As the gap between the apical and the coronal components of the combination distraction dental implant is advanced, the distraction gap is expanded providing for new bone formation. Once the desired amount of new bone growth has been achieved, an abutment replaces the last expansion component of the three component combination distraction dental implant and the apical and the coronal components with the abutment connecting them together is allowed to heal in position.  
      The following is a specific representative example of the application of the combination distraction dental implant methods and device of the present invention to the science and technology of dental implants. It is believed that most, if not all, current dental implants could be modified, in accordance with the present invention, to allow for the application of the additional distraction as long as the components of the combination distraction dental implant are sufficiently strong to withstand the loads and to effectively distribute the loads from the combination distraction dental implant to the bone.  
      As shown in  FIGS. 2 and 3 , one specific, presently preferred, embodiment of the combination distraction dental implant of the present invention is generally designated by the numeral  40  and comprises three components including a two component  42 ,  44 , presently preferably, externally threaded cylinder like portion  46  and at least one initial connecting component  48  or one of a plurality of expansion components  48   a,    48   b  for cooperating with the two components  42 ,  44  an apical component  44  and a coronal component  42  for operatively connecting and for controllably separating the two components.  
      The two components  42 ,  44  presently preferably, are about four (4.0) mm in diameter and combined are about eight (8.0) mm in length, and are made of, presently preferably, commercially pure Grade IV titanium (other metals, metal alloys or metal substances could be used as long as they meet or exceed the parameters for material used in dental implantology). The outer surface of both components of the cylinder like portion of the present invention can be conventionally covered/roughened with a surface coating extending about one (1.0) mm to about two (2.0) mm from the superior aspect of the combination distraction dental implant along the entire length of both components  42 ,  44 . The two components  42 ,  44  of the combination distraction dental implant  40  are, presently preferably, cylinder like, and having, presently preferably, conventionally externally threaded, with the, presently preferably, clockwise treads starting about two (2.0) mm from the superior aspect of the combination distraction dental implant along the entire length. The apical component  44  of the combination distraction dental implant includes conventional means  50  for enhancing integration with the bone and for reducing rotation of the implant once integrated with the bone. One example, and the presently preferred means, is three oblong apical vents  52 ,  54 ,  56  about one (1.0) mm in diameter located about one half (0.5) mm superior to the end of the apical component  44  of the two components of the combination distraction dental implant  40 .  
      The two components  42 ,  44  have a combined hollow portion  60  extending from the superior surface for about six (6.0) mm of the total about eight (8.0) mm length of the two components  42 ,  44  (completely throughout the about four (4.0) mm length of the coronal portion  42  and about two (2.0) mm into the upper portion of the apical portion  44 ). The hollow portion  60  is stepped with the apical portion, about a two (2.0) mm portion, having about a two (2.0) mm diameter and the coronal portion, about a four (4.0) mm portion having about a three (3.0) mm diameter. The about two (2.0) mm superior, coronal, portion  62  of the hollow inner portion  60  has a hexagonal configuration, with the coronal portion about one half (0.5) mm flared outward producing a knife edge junction. The remaining inner portion of the about two (2.0) mm long portion, of the about three (3.0) mm wide portion is round, with, presently preferably, clockwise threads. The hollow about two (2) mm diameter portion  61  of the apical component  44  is round, with, presently preferably, clockwise threads.  
      Prior to, during and after initial placement, the horizontal interface between the two about, four (4.0) mm long components  42 ,  44  has no noticeable gap (See  FIG. 4 ). This interface may be smooth or have interlacing or interlocking complimentary locking members on the facing surfaces  58 ,  59  of the components  42 ,  44 . Such members would prevent rotation and torsion at the interface during the healing process and before the components become integrated with the bone. As mentioned above, the combination distraction dental implant device  40  also includes one of the plurality of incrementally sized expansion components  48   a,    48   b,  as shown in  FIGS. 8A and 8B , for operatively connecting the two components  42 ,  44 . As described above, the expansion component provides for separation between the above described two components  42 ,  44  to form a distraction gap  70 , once the two components  42 ,  44  connected by the initial connecting component  48  are properly integrated with the bone  80 . (See  FIGS. 4-6 )  
      As illustrated in  FIGS. 8A , and  8 B, the expansion component preferably comprises one of a plurality of separate interchangeable members  48   a,    48   b  of varying lengths each having means for separating the two components  42 ,  44 . The end portion  112  of the interchangeable expansion components  48   a,    48   b  must be, of necessity, rotatable in the hollow portion  61  of the component  44 , as will be discussed in detail below. The plurality of expansion components  48   a,  and  48   b  in one exemplary example, comprise separate members of about five (5.0) mm  48   a,  about ten (10.0) mm  48   b,  about thirteen (13.0) mm (not shown), about fifteen (15.0) mm (not shown), and about 18.0 mm (not shown) in length, presently preferably, made of commercially pure titanium or equivalent. Each expansion component is, presently preferably, T shaped with a threaded vertical portion  82  and a smooth superior cap portion  84 . The vertical portion  82  is about two (2.0) mm in diameter with threads operatively corresponding to the internal threads of the two components  42 ,  44  of the distraction implant device  40  and for cooperation therewith. The height of the threaded portion has varying lengths, such as, for example, about four and one half (4.5) mm for the about five (5.0) mm expansion component, about eight (8.0) mm for the about ten (10.0) mm expansion component, about eleven (11.0) mm for the about thirteen (13.0) mm expansion component, about thirteen (13.0) mm for the about fifteen (15.0) mm expansion component, and about sixteen (16.0) mm for the about eighteen (18.0) mm expansion component.  
      The initial connecting component  48 , and the final abutment component  100  each have a threaded end portion  110  for interaction with the hollow portion  61  of the apical component  44 . The end portion  112  of the interchangeable expansion components  48   a,    48   b  must be, of necessity, rotatable in the hollow portion  61  of the component  44  because, as the expansion component is rotated the expansion component  48   a  must not be fixedly connected to the apical component  44  in such a way as to prevent the end  112  from freely rotating in the apical component  44  as both the apical component  44  and the coronal component  42  remain rotationally fixed in the bone as the gap between the two components  42 ,  44  is increased axially by the interaction of the external threads of the expansion component  48   a,    48   b  with the internal threads of the coronal component  42 . Other conventional means for maintaining the rotatability of the end portion  112  in the hollow portion  61  would be acceptable.  
      The key concept is that the apical component  44  and the coronal component  42  remain stationary in the bone and rotational movement of the expansion component  48   a,    48   b,  provided by, such as for example, the interaction of the threads of the expansion component with the internal threads of the coronal component  42 , provide for the separation of the coronal component  44  and the apical component  42 . Specifically, during the rotation of the expansion component after the end  112  of the expansion component  48   a  is contiguous with the bottom surface  63  of the apical component  44 , the end component  112  freely rotates within the hollow portion  61 .  
      The superior aspect, cap portion  84 , of the initial connecting component  48  (see  FIG. 2 ) is, presently preferably, about four (4.0) mm in diameter and either about one (1.0) mm high when unexposed or about three (3.0) mm high when exposed for the five (5.0) mm long component or about two (2.0) mm high for the remaining above described expansion components.  
      When seated, the about one (1.0) mm cap of the initial connecting component  48  sits flush with the edge of the combination distraction dental implant, while the about three (3.0) mm cap extends beyond the edge of the combination distraction dental implant  40  through the mucosa  90 , intraorally (See  FIGS. 4-7 ). The about two (2.0) mm cap has concentric lines spaced about 1.0 mm apart along the entire length of the cap. The superior aspect  92  of the cap is tapered inward along the about one half (0.5) mm of the one (1) mm height to correspond to the internal taper of the superior aspect/knife edge of the combination distraction dental implant  40 . The top, superior surface  94  of the expansion component cap has about a one (1.0) mm diameter, hexagonal shaped aperture  96 , about two (2.0) mm in depth. This aperture  96  provides the mechanical access to remove the initial connecting components  48  and to both place and remove a selected one of a plurality of the expansion components  48   a,    48   b  from its connecting position between the two components  42 ,  44  and to activate the distraction process via a corresponding L or T shaped hexagonal key (not shown), of about one (1.0) mm diameter, presenting preferably, made from stainless steel, by causing separation of the two components  42 ,  44  of the combination distraction dental implant  40 , as will be described more fully below.  
      As shown in  FIG. 8C , the abutment  100 , for final connecting of the two components  42 ,  44 , for being integrated with the bone and for attaching the prosthesis such as, for example, a crown  28 , a bridge or dentures ( FIG. 1 ) will now be described. The abutment  100  has essentially the same dimensions of the expansion components  48   a,    48   b  but the overall length and the cap portion  84  as well as the end  110  most remote from the cap are necessarily altered. The cap portion  102  of, such as, for example, the crown attaching expansion component or abutment  100  is, in its presently preferred configurations, about six (6.0) mm high and about four (4.0) mm wide at its base, extending upward with no more than an about twenty-three (23) degree taper. From the widest aspect, the cap  102 , presently preferably, tapers inward about two (2.0) mm to form a taper that provides for a friction fit with the internal knife edge taper of the superior portion of the combination distraction dental implant. The cap taper meets the threaded portion at about a right angle. The abutment cap  102  has the same about one (1.0) mm diameter hexagonal access aperture in its superior surface. This final abutment component is the component utilized as the base for the prosthesis such as, for example, a crown  28 , a bridge or dentures after sufficient bone growth through distraction osteogenesis has been generated by the controlled separation of the two components  42 ,  44  by the expansion component. The cap portion  102  may also be configured as a ball, bar, magnet or any abutment, as is known in the art. The end  110  of the abutment  100  must be operative to interlock with the component  44  such that during bone integration, the two components  42 ,  44  remain fixedly connected.  
      As illustrated in  FIGS. 4-7 , in one presently preferred-method for the distraction of bone using the combination distraction dental implant  40  described above, the combination distraction dental implant  40  device is placed by making a series of osteotomies within the dentoalveolar bone in the predetermined site or area where additional bone is required. Prior to any surgical technique, proper treatment planning must be performed, including a physical examination, X-ray studies and consultation with the dentist fabricating the prosthetic crown.  
      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, incisions are made along the crest of dental ridge, in the predetermined site. The underlying bone is conventionally exposed by raising a full thickness mucoperiosteal flap with an elevator. The exposed bone is conventionally evaluated by palpitation for bone density and quality.  
      Using sequentially sized drills, (an acceptable set is available from Dentsply® Implant, 15821 Ventura Blvd., Ste. 420, Encino, Calif. 91436) as is presently preferred, an osteotomy is created in the planned implant placement site, it being understood that other conventional procedures could be used to create the osteotomy. First, presently preferably, about a two (2.0) mm diameter pilot drill is used to initiate the osteotomy site, such as, for example, to a depth of about eight (8.0) mm. All of the bone drilling procedures include copious amounts of irrigation, (internally and/or externally). Conventional paralleling pins of about two (2.0) mm diameter are placed into the pilot holes to ensure the proper orientation and location of the combination distraction dental implant in the bone. The osteotomy site is enlarged by utilizing progressively wider drills. The proper orientation and depth of the osteotomy site is verified by re-placing the paralleling pins. Optionally, the parallelism of the osteotomy site can be verified by X-rays. 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.  
      At this point, the three component combination distraction dental implant  40  of the present invention is placed (see  FIG. 4 ) into the bone  80  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 the incision is conventionally closed with the cap  84  being, presently preferably, covered by the gum tissue. In a one-stage implant procedure, the cap is exposed, as described above.  
      The three component distraction dental implant  40 , presently preferably, with the initial connecting expansion component  48  is then allowed to heal and become integrated into the bone (a process that takes approximately four months). It should be understood that it may be possible to substitute a first expansion component  48   a  in place of the initial connecting component  48 , as long as the portion extending above the gum does not extent above the top of any adjacent tooth and as long as other medical concerns are met as appropriate.  
      After physical examination and X-ray evaluation are utilized to ensure osseous incorporation of the combination distraction dental implant, the top  84  or superior portion of the combination distraction dental implant is exposed during the Phase  11 , uncovering surgical procedure in a two-stage procedure where the implant is completely covered (not shown). In the case of a one-stage implant, the cap is not covered, as shown in  FIGS. 4-7 .  
      During either the one-stage or the two-stage procedure, local anesthetic is administered, after the patient has been prepared for surgery. Incisions are made in the gum over the site of the combination distraction dental implant (two-stage procedure). A full thickness mucoperiosteal flap is raised along the buccal portion utilizing a periosteal elevator. Osseous integration of the two component combination distraction dental implant  40  into the bone is verified visually and tactilely. Using a burr and copious amounts of irrigation, a corticotomy is placed in the buccal bone horizontally, adjacent the two components separation point (about 4.0 mm from the superior dental aspect of the combination distraction dental implant). The horizontal corticotomy, presently preferably, extends laterally about one (1.0) mm to about seven (7.0) mm beyond the margin of the two component combination distraction dental implant or as appropriate, depending upon the judgment of the surgeon.  
      Two vertical bicortical osteotomies are created extending from the horizontal cut to the crest of the dental ridge. This cut can also be preformed in the opposite direction, apically to allow for the sinus lift procedure, as described later. The vertical osteotomies are completed with a thin osteotome. Care is taken not to perforate the lingual periosteum or mucosa. The horizontal cut remains as a corticotomy. If the combination distraction dental implant has been placed in an area of limited bone stock, about one (1) to about two (2) millimeters, between the implant and the adjacent teeth/nerve, then only corticotomies are performed including on the lingual.  
      At this point, the patient has been prepared for the process of growing new bone stock by distraction osteogenesis prior to the prosthesis such as, for example, a crown, a bridge or dentures being connected to the implant. First, if used, the initial connecting component  48  is removed and replaced by a first adjustable expansion component  48   a.  The incision is then closed, with the cap of the adjustable expansion component  48   a  extending about five (5.0) mm through the mucosa, intraorally.  
      The patient is educated as to the care and activation of the three component combination distraction dental implant. After allowing for a period of initial healing, a latency period (of about 5-7 days), the adjustable expansion component  48   a  is maneuvered, (turned) thereby separating the two components  42 ,  44  of the combination distraction dental implant  40  of the present invention (about 1.0 mm per day) in divided doses, as is known in the art, and thus creating and widening the distraction gap  70  in the bone.  
      The patient is educated to make the adjustment necessary to increase or widen the gap  70  each day. Thereafter, the patient is seen for follow-up and evaluation as appropriate. Since the plurality of expansion components  48   a,    48   b  are incrementally sized by about five (5.0) mm, the maximal distraction gap advancement achieved by any one expansion component is about five (5.0) mm. If greater bone growth is required, the first expansion component  48   a  can be removed and replaced by the next longer sized expansion component  48   b  and the distraction process reinitiated, to achieve further bone regeneration, as above (See  FIGS. 4-7 ).  
      If an initial expansion component  48   a  was used instead of the initial connecting component  48 , the actuation process, after healing, is followed, as described above.  
      Since the typical height of a natural tooth crown  111  above the gum  90  is about eight (8.0) mm, in order to properly function, the distal or cap end of the expansion component  48   a  should not extend above the level of the lowest adjacent tooth crown  111 .  
      After sufficient bone height (about 5 mm to about 15 mm) is achieved, the distraction process is halted and the last adjustable expansion component is removed and replaced with the abutment  100 . However, since the new bone is still relatively weak and incompletely ossified, a period of about four to about six weeks is required before the fabrication and installation of the final prosthesis such as, for example, a crown  28 , a bridge or dentures. Additionally during this period, the abutment  100  now connecting the two components  42 ,  44  of the combination distraction dental implant becomes incorporated with the bone thereby increasing the rigidity of the installed combination distraction dental implant device  40  of the present invention.  
       FIGS. 4-7  illustrate the distraction process according to the present application.  FIG. 4  shows the combination distraction dental implant  40  of the present invention newly installed in an area having insufficient bone to support an optimal dental implant.  FIG. 5  shows an intermediate bone growth situation where some bone has been regenerated but not enough to support an optimal dental implant. Note the increased separation between the coronal  42  and apical  44  components and the increased distraction gap  70 .  FIG. 6  shows another intermediate bone regeneration position with  FIG. 7  showing the final result with the abutment  100  being positioned connecting the two components  42 ,  44 .  
      As clearly illustrated in  FIGS. 4-6 , as the bone is regenerated and the expansion component  48   a  becomes nearly flush with the gum, the expansion component connecting the coronal  42  and apical  44  components is removed and replaced with the next longer of the plurality of expansion components  48   b  such that, presently preferably, the end extending intraorally does not extend above the adjacent teeth, a height of about five (5) millimeters.  
      The foregoing description illustrated one specific application of the technique and technology of distraction osteogenesis to the field of dental implants using an exemplary 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 of the three component combination distraction dental implant devices is unlimited. By modifying minor details of the basic design, such as, for example, splitting the dental implant horizontally 60/40% rather than the 50/50% as described, altering the length or taper of the expansion component, changing the pitch of the screws, etc., are just a few of the unlimited possible variations.  
      Nevertheless, in all possible variations, the basic concept remains as described, i.e., utilizing two separate components  42 ,  44  connected by one of a plurality of adjustable expansion components to achieve sufficient bone generation in an area of deficient bone in order to place an optimum dental-implant. Advantages of combination distraction dental implant of the present invention include providing new bone 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 three component combination dental implant described above provides for increased versatility by using a plurality of interchangeable, incrementally seized expansion components  48   a,    48   b  to continuously adjust the distraction gap  70  during the bone regeneration process without additional surgical procedures. Consequently if more bone is required than initially anticipated, then the expansion component, and only this single component, is removed and replaced with a longer one to provide the additional bone generation until sufficient bone is generated then the last expansion component is replaced by the abutment  100 .  
      As shown in  FIGS. 9-12 , utilization of the device of the present invention for cases where the bone is deficient and the sinus must be elevated. As shown in  FIG. 9 , the device  40  of the present invention is placed in the bone  80  with the apical component  44  proximate the boundary between the bone  80  and the maxillary sinus  200 .  
       FIGS. 10-12  illustrate the regeneration of the bone as the apical component  44  effectively lifts the maxillary sinus  200  in gradual phases through distraction osteogenesis by regenerating bone between the apical  44  and the coronal  42  components.  
      In this method, one possible approach is to have both the coronal component  42  and the apical component  44  generate bone by having the apical component  44  push toward the sinus  200  and the coronal component  42  move toward the crown of the adjacent teeth and increase the bone between the sinus and the gum. Therefore, when the force is applied to separate the two components, distraction takes place by moving both components, depending upon the bone cuts (osteotomies), as previously described.  
      As can be seen from the drawings, it is believed possible to elevate the maxillary sinus while generating sufficient bone to provide the equivalent of the conventional bone graft system of the prior art. One representative prior method and apparatus for lifting a descendent portion of the maxillary sinus is disclosed in U.S. Pat. No. 4,682,951, the disclosure of which is herein incorporated by reference.  
      Thus, it can be seen that the new combination intraossoeus dentoalveolar distraction osteogenesis implant and method of using includes a new three component device which reduces the number of surgical procedures required to place a dental implant in an area initially having insufficient bone stock to support the optimal implant and is more aesthetically pleasing during the actual distraction process as compared to prior devices and methods.  
      It should be clear to those skilled in the art that the above concept of a three component distraction device with interchangeable expansion components is not limited to use as a dental implant and could be used as a general distraction device in the maxillofacial region, for example, by externally attaching the coronal component and the apical component to appropriate areas of a bone by connecting means, such as, for example, pins, screws, rods, titanium discs, etc., as known by those skilled in the art. When attached external to the bone and soft tissue (extra mucosal), the same distraction principles would apply including the variable size interchangeable connecting components.  
      In fact, a plurality of interchangeable, incremental devices, each device comprising a first component operatively, removably connected to a first bone connecting means, a second component operatively, removably connected to a second bone connecting means and a guide means operatively connecting the first and second components could be positioned external to the skin or soft tissue of the mouth intraorally to effectuate distraction of bone, such as, for example, the mandible. Such a device would have the advantage of being initially much smaller, resulting in considerable increased patient comfort because it is not necessary for the initial device to be the length of the final distance to be distracted, as with currently used devices, such as, for example, the devices shown in  FIGS. 11 and 14  in the article entitled “Osteodistraction” mentioned above. Also, the device causes less tissue displacement (lips) thereby reducing aesthetic concerns and is better tolerated by the patient. Finally, the device is smaller, due to its incremental construction, and, thus, easier to remove at each intermediate position and at the end of the distraction process.  
      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.  
     Combination Distraction Dental Implant and Method of Use  
     Abstract of Disclosure  
      A combination distraction device and methods of using are disclosed. The combination distraction device comprises a two component portion (an apical and a coronal component) and an expansion component for separating the two components once the device has been initially integrated into the bone. Internal threads of the apical and the coronal components are adapted to operatively cooperating with the threads of the expansion component such that the distance between the apical component and the coronal component is selectively varied. When assembled, the expansion component is advanced into the two separable components by rotating, for example, the expansion component in a clockwise direction. As the expansion component is advanced into the two component portion of the combination distraction dental implant, one end of the expansion component engages the end of the internal thread in the apical component, causing separation between the apical and coronal components thereby forming a gap. Since, when placed in a patient, the apical and coronal components become mechanically or biologically integrated, fused intra-osseously to the bone, separating these two components expands a distraction gap previously made in the bone proximal the separation point between the two components and provides for the formation of new bone and soft tissue.  
      The following represents additional language and/or description from that of my prior application Ser. No. 08/886,078 filed Jul. 2, 1997.  
       FIG. 14 a  perspective view of a lower jaw section  140  in which a gum section  1   42  is recessed. One object of distraction osteogenesis is to raise (from the perspective of the lower jaw) the recessed bone and gum level so as to provide sufficient and aligned bone support for a dental implant inserted in the jaw. In accordance with this invention, the combination dental implant-distraction device  144  (which is mechanically identical to the distractor component shown in  FIGS. 8A and 8B  of my prior application) is provided with a cylindrical head  146 , an upper threaded or longitudinal shank section  148  and a lower, smooth walled and flat tipped, reduced diameter section  150 . In the embodiment of  FIG. 14 , the shaft segments  148  and  150  are cylindrical, and the smooth shaft and tipped section  150  is reduced in diameter with respect to upper threaded shaft section  148 . A central, hex-shaped blind bore  143  is provided which cooperates with a suitably-shaped turning key to facilitate mechanical, incremental rotation of the device, to promote distraction osteogenesis.  
      In accordance with the method of this invention, the unitary, i.e., one-piece, combination dental implant-distraction device  144  is to be inserted in the jaw  140  of the patient. A suitable drill is selected and used to predrill a bore into the jaw, large enough to accommodate device  144 , which is then inserted in a conventional tapping and screw/rotation movement. A slight undercut is provided so that as the combination dental implant-distraction device  144  is inserted in the jaw, it is relatively fixedly inserted therein with the threads initially-turning into and bearing against the adjoining tissue, which becomes compressed and deformed to accommodate the threaded section  148  as it is threaded into the jaw  140 .  
      In accordance with the principles of this invention, the combination dental implant-distraction device is inserted far enough into the jaw until its bottom, smooth, or flat-tipped surface  152  bears against a corresponding flat or base surface  154  in the floor of the jaw, as it develops after the initial drilling operation has occurred. This floor or base  154  of the jaw prevents the bottom  152  of the dental implant-distraction device from moving further downwardly as it rotates in the jaw. Rather, further rotation will cause the tissue of the jaw to ride up the threads of the combination dental implant-distraction device since the bone at the base of the drilled bore blocks downward movement of the device, even as rotation is accomplished. As a consequence of the direction of the surgical cut, the new bone growth direction can be adjusted, as desired, so that sinuses can be pushed upwardly.  
      In an alternative embodiment of  FIG. 15 , an additional base support  156  in the form of a flat disc (similar in shape to a washer) may be inserted in the drilled out, lower portion or blind bore of the jaw upon which the bottom, smooth surface  152  of the distraction device mechanically bears. By providing the additional base support  156 , there is believed to be less trauma to the patient and greater likelihood that the dental implant-distraction device  144  will not move downwardly in the jaw. The base member  156  could be constructed as the apical member illustrated in  FIGS. 1 through 13  of my prior application or as the shown flat disc, washer, or base member. The base member could, as an alternative, be made of a resorbable material such as PLA or PGA which would ultimately resorb into the jaw tissue after a suitable period of time prior to which its usefulness as a base member would have been fully realized.  
      In accordance with the method of this invention, and referring to  FIGS. 14 and 15 , after the dental implant-distraction device  144  is inserted in the jaw as illustrated in  FIGS. 14 and 15 , a surgical cut is provided to separate the upper jaw section segment  158  from the remaining portion of the jaw section  160  along a section line  162 . This section line separates the jaw segment  158  from the remaining portion of the jaw section  160  and allows jaw segment  158  to move upwardly incrementally in order to reestablish a new upper gum line as ultimately illustrated in  FIGS. 6 and 7  of my earlier application. Distraction osteogenesis occurs in the gap between the upper surface of the jaw segment  160  and the lower surface of jaw section  158 . As osteogenesis occurs, section  158  continues to be incrementally moved upwardly by rotation of the dental implant-distraction device  144 , as described. The tissue rides up the inclinded surfaces of the threads of the device and new bone is grown. In this manner, a new gum line is established and a secure location is provided for a dental implant.  
       FIG. 16  is an enlarged sectional view illustrating the jaw tissue  162  growing into the threads  164  and threaded or inclined surfaces  166  of the threaded section  148  of the combination dental implant-distraction device  144 . Since there is sufficient jaw tissue  164  bearing against the upper portions of the helix of the threaded section  148 , upper jaw segment  158  will move upwardly because of the vertical forces imparted by the helical thread  166  on-the jaw tissue of upper segment  158  causing upper segment  158  to move upwardly with respect to jaw section  160 . This is possible because the bottom  152  of the dental implant-distraction device cannot move downwardly as it is fixedly bearing on the uncut jaw section  154 , as seen in  FIG. 14 , or on the bearing surface  156  as shown in  FIG. 15 . Thus, incremental rotation of the device causes upward movement of jaw section  162 , riding up the inclined threads of the device. This distraction will be filled in my bone in-growth.  
      The above device and method eliminates the need for the separate coronal and apical members  42  and  44 , as illustrated in  FIGS. 1 through 13  of my prior patent application.  
      As may be easily understood, with this dental implant-distraction device  144 , only a single mechanical component and surgical procedure is required to yield not only distraction osteogenesis but also the sufficiently strong joining of the implant  144  to the jaw  160  allowing a sufficient, sturdy platform upon which a conventional dental crown or other dental prosthesis may be placed as illustrated in  FIGS. 1 through 13  of my prior patent application.  
       FIG. 17  is a sectional view of another embodiment of my invention in which a cap or cover  170  is employed which is adapted to sit and frictionally fit over the dental implant-distraction device  144 . It provides a more hygienic and sanitary condition to the procedure, during the time that the implant/distraction device is being rotated to cause distraction osteogenesis to occur. The cover or cap  170  may be frictionally secured or conventionally secured but, of course, should be easily removable to allow access to the head of the distraction device to permit easy selective incremental rotation thereof. Thereafter, the cap can be easily replaced. Another embodiment of the invention discloses the use of a head protecting cap  179  which surrounds the hex head  181  of the device. This cap, too, can be frictionally secured and is intended to protect the tissue, at the device-tissue intersection from debris.  
      In accordance with a further feature of this invention (See  FIG. 17 ), the center of the distraction device  144  may be provided with a hollow, center bore  172  through the head and shaft, which communicates with a plurality of radially extending branches  174  which exit the outside circumferential surface of the device. The branches  174  directly communicate with that portion of the jaw tissue which is closest to the distraction device. A syringe or other material insertion device may be inserted into bore  172  to dispense or apply BMP to the jaw tissue through the center bore and branches  174  to enhance tissue healing. As the device accomplishes distraction osteogenesis, the cap  170  will slowly ride off of the device until it can be easily removed.  
       FIG. 18  is yet another alternative embodiment of the combination dental implant-distraction device. Here, a basic cylinder is provided, in which the center section  176  is smooth and the outer longitudinal sections  178  are oppositely threaded. The combination dental implant-distraction device of  FIG. 18  is employed in those situations in which an H-cut is surgically provided to the jaw, permitting concurrent movement of upper and lower jaw segments by their bearing against and riding over the helical threads in threaded segments  178 , as the dental implant-distraction device is rotated. This embodiment would be used, for example, where growth in two areas was desired, e.g., expanding the sinus area upwardly while also extending downwardly the gum line of the upper jaw.  
       FIG. 19  is yet another alternate embodiment of the distraction/connecting member. This, preferably, relates to the three piece device fully described in my prior application. As can be seen, one or more (preferred three radially-spaced) anti-rotational grooves or fluted section(s)  202  are provided to the upper threaded section  204 . The fluted section(s)  202  enhance bone in-growth. Bone in-growth has been found to be more effective into smooth-walled transitional surfaces than sharp-walled or cornered transitional sections. The section(s)  202 , in the preferred embodiment, extend to the bottom surface  206  of the larger diameter section  208  and, preferably, extend at least 50% up from bottom surface  206 , of the axial length of the larger diameter section  208 . The head end  205  of the device is formed as a wide-diameter disc, beneath the hex-head  207 . The wide diameter of the disc  209  and its flat bottom surface  211  ensure that the implant remains immobile, i.e., the disc  213  inhibits rocking of the implant.  
      While this invention has been described with respect to mechanical threaded segments for vertically lifting jaw section for distraction osteogenesis, it is also possible that a hydraulic or other ratchet/lifting system could be employed to provide sufficient bearing force or surfaces between the tissue and respective distraction, coronal or apical members allowing the segmented jaw section or the members in the embodiments to move with respect to the jaw and/or distraction member. The relative movement may be accomplished by a combination of a hydraulic system, employed with a step-like vertical changer, much in the way of a tire jack or the like. Similarly, the inventor envisions that distraction osteogenesis could also be accomplished by a telescopic, mechanical arrangement with the selective introduction of fluid into connected chambers service to increase vertical spacing to encourage bone growth. Other mechanical arrangements, of course, could be employed to separate the segmented tissue, all toward the desired end of bone growth and an implant support.  
       FIG. 20  shows yet another embodiment of the invention. Here, similar to my prior disclosed three-piece device for a dental implant and distraction mechanism, a unitary implant and distractor  200  is provided with supporting head  202  and downwardly extending cylindrical shaft  204 . The bottom  208  is a smooth-walled tip. Here, too, a hex-shaped hole  206  is provided in the head to facilitate incremental rotation of the device by a suitably shaped turning key. Here, as described previously, the end of the shaft is provided with a reduced-in-diameter smooth walled section  208 . The shaft  204  is externally threaded, as at  210 . Beneath the head  202 , is a bevel or undercut surface  212 . In this embodiment, however, a separate collar or coronal member  220  is located extra-osseously. The collar surrounds the cylindrically-smooth outer surface of the superior or top portion of the device and mechanically functions as the coronal member of my prior device. Thus, the surrounding cap acts as the coronal member of my prior three component system, only now the coronal member is extra osseous. As is apparent, the coronal member can be intra- or extra-osseous. When the coronal member is extra-osseous, the member protects the gum line from becoming invaded with debris. This prevents infection. The ring-like collar  220  is flat on its base, as at  222 , which sits atop the gum surface. The inventor contemplates that collars can be formed of a variety of shapes and sizes to roughly match that of the tooth around which the collar is placed. The shapes protect the boundary, between implant and gum, from debris and bacteria. The cap can be triangular, ovoid, box-shaped, depending on the desired tooth shape. As distraction osteogenesis proceeds, the cap will slowly “pop-off” and be discarded. Prior thereto, the cap has promoted gum healing and protected the implant-gum linefrom bacteria, infection and decay. The outside wall of the coronal member  220  defines a cylindrical outer wall  224 . The coronal member  220  is provided with internal threads  226  which mate with the external threads  210  of the shaft  204  of the unitary dental implant and distractor  200 . The top surface of the coronal member  220  is provided with an undercut  230  which mates and accepts the bevel surface  212  of the head  202  of the dental implant and distractor  200 . The device operates in much the same way as the prior disclosed devices, namely, rotation of the device causes the surgically sectioned jaw to move relatively upwardly, riding up the inclined surfaces of the threads, with respect to the coronal member. The coronal member will not rotate since it is provided with one or more downwardly extending spikes (not shown in the drawing) on its bottom or flat surface  222  which project into the gum. This prevents rotation of the coronal member and ensures that rotation of the shaft causes the sectioned jaw to move upwardly with respect to the coronal member.  
      While this invention has been described with respect to particular applications, it will be appreciated that the described dental implant-distraction may be used for other purposes. Many other variations and applications of the invention will be apparent. The above specification and the detailed description of the preferred embodiment are to be considered as representative only, as the scope of the invention is intended to be covered by the scope of the claims, as interpreted by the courts, and their reasonable and legal equivalents, as also interpreted by the courts and the applicable statutes. 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.