Biocompatible form and method of fabrication

Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone

Reexamination Certificate

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Details

C623S017180, C433S199100, C433S201100

Reexamination Certificate

active

06645250

ABSTRACT:

CROSS-REFERENCE TO RELATED APPLICATIONS
Not Applicable.
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'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'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 interproxlmal 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'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

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