CROSS-REFERENCE TO RELATED APPLICATION This invention is disclosed in part in our co- pending application entitled Orthodontic Anchor, Serial No. 07/659,680, filed on February 25, 1991, the priority of which is claimed for the common subject matter.

BACKGROUND OF THE INVENTION Skeletal deformities become evident during the growth of an individual, or may be acquired from trauma, tumor resection, or systemic disease.

Correction of bone deformities requires either surgical treatment to reposition the deformed bones into a "normal" relationship, or by guided bone movements. Currently pins or other transosseous devices are used in conjunction with surgical procedures to anchor the bones and to maintain bone position during treatment and healing. These transosseous devices have limitations, such as in small bones and in regions of the human skeleton such as the face where other vital structures exist preventing pins from being used. The correction of facial deformities presents clinical challenges which have led to this invention.

In patients with atrophic maxillary or mandibular bone, prosthetic rehabilitation with conventional dentures is often not satisfactory since the patient has very little bone to retain the dentures. In order to rehabilitate these patients, bone grafting is often required. However, many patients are not candidates for bone grafting due to health reasons. Their rehabilitation requires only an anchor for improved retention of their prosthesis. This invention can be placed either onto the bone or into a shallow, 3mm depression and will provide anchorage for the patient's dentures. Placement of the bioactively coated device onto bone will allow bone deposition over the entire

surface of the 2-3 mm thin device, increasing its ability to withstand the forces of chewing.

Often the earliest signs of maxillary or mandibular growth disharmony is dental malalignment. Once recognized, it is possible to guide the growth of segments of the cranio-facial skeleton in order to minimize the need for surgical correction of the deformity.

Maxillary hypoplasia exists in all three dimensions. Transverse deficiency of the maxilla is often treated by the orthodontist with orthopedic palatal expansion. Deficiency in the maxillary in the vertical or anterior- posterior direction has not been satisfactorily cured by non-surgical guided movements because of a lack of a stable or non-mobile anchorage source for orthopedic movements.

Mandibular deficiency can be corrected by functional appliances which position the mandible forward, and presumably allow for posterior condylar appositional growth which stabilizes the mandible in this forward position. Orthodontists employ orthopedic traction in all three dimensions to control or direct the development of a bone to a favorable location.

Cleft palate patients often have transverse, anterior-posterior, and vertical dysplasia.

Reconstruction of these patients often involves orthodontic alignment of the segments prior to bone grafting the defects. However, the defects can be large and difficult to manage when the patient is young. The deciduous dentition can also be difficult to manage in regards to orthodontic anchorage preventing definitive alignment of the arches until the patient is in the early teens.

All orthodontic and orthopedic forces adhere to Newton's Law of Reciprocal Forces. If a force is applied to retract, or pull back on object such as a

tooth, there exists an "equal and opposite" force to move another tooth forward. The resistive value of the posterior teeth is known as anchorage.

Orthodontists offset these reciprocal tendencies by using an extraoral force known as a headgear to augment the resistive value of the molar teeth. However, patient compliance may be poor because many patients do not want to wear the headgear, compromising orthodontic therapy and often the final result. The problem is that the retractive forces are usually continuous, acting 24 hours a day. Realistically most patients will not wear a headgear more than 10 - 12 hours a day. Therefore, the posterior anchorage is typically fortified 40 - 50% of the time. All too often inconsistent usage or overt non-compliance reduce this effect even more.

Previous work in this field indicates that endosseous implants can be used to anchor orthodontic forces for tooth movement. All of the previously used implants were cylindrical or screw shaped, from eight to 22 mm in length. These studies indicate that osseointegrated implants have been used to anchor realignment of teeth, without moving the implants. These implants were placed deeply into the bone. In the field of orthopedics, pins are routinely placed through bones and connected to various supporting frameworks to maintain bone position and also to act as an anchor for guided bone movements. Morbidity is associated with placing pins through the cortical and cancellous bone, and if complications such as pin loosening or infection occurs, loss of bone structure can occur.

Clinically, hydroxylapatite coated cylindrical implants have been used since July 1984. Solid blocks of dense hydroxylapatite are available for interpositional and onlay grafting of defects during

orthognathic surgery. The onlay grafts were used exclusively for cosmetic augmentation of facial defects without carrying loads.

A need exists for obtaining anchorage directly on parts of the jaws in order to allow the orthodontist the capability for moving teeth and bones in any direction.

A need also exists for obtaining anchorage directly on parts of other bones to allow the orthopedic surgeon the capability for moving the bones in any direction, without the use of transosseous pins.

An anchorage device should be small, allow for various parts to fit into it for versatility of use, and be able to fit on bone and be applied to the bone surface only or within a shallow depression of the bone. If the anchorage device requires placement deeply into or through bone, then it may be difficult to place the device in children because of potential damage to unerupted teeth. Also size limitations of small bones prevents the use of transosseous pins. In addition, for cranial bone movements for cases of Crouzon's or Apert's syndrome for example, intra-bony devices may interrupt vital structures such as dura or sinusoids.

The objectives of this invention can be stated as follows:

1. It must not deeply enter the bone but should attach to it, or lie flush with the surface penetrating the bone no more than 3 mm to allow bone overgrowth for extended applications; 2. it should be relatively thin to lay under soft tissue against bone, without creating significant inflammation; 3. it should have versatility of attachments in order to assume a role for an orthodontic anchor, a prosthetic anchor, an orthopedic

anchor; or to attach other devices to a bone such as a pacemaker. 4. it must have sufficient shear strength to absorb chewing forces and forces placed upon it from orthodontic, occlusal, and orthopedic loading.

SUMMARY OF THE INVENTION As a orthodontic anchor system for treatment of growth disharmony, bone deformity, bone atrophy, and malalignment of teeth, an onplant surgically placed in a subperiosteal tunnel on or into a shallow depression in the skeletal bone, allowing biointegration^between the onplant bone interface and the bone, after which a system is attached to the onplant for treatment. The system may consist of a palatal bar which is attached to the anchor system, and the palatal bar is also attached to bands around two teeth, holding them non-mobile, permitting the orthodontist to treat the malalignment of the teeth. As a prosthetic anchor the thin, completely bioactively coated onplant is surgically placed in a shallow depression in the bone to allow for bone to heal on all of the onplant's surfaces, allowing biointegration between the onplant bone interface and the bone, after which a device is attached to the onplant to provide anchorage for prothetic devices. The optional placement of the completely bioactively coated onplant into a shallow depression on the bone is for extended applications.

As an orthopedic anchor the onplant is surgically placed in a subperiosteal tunnel on or into a shallow depression in the skeletal bone, allowing biointegration between the onplant bone interface and the bone, after which a device is attached to one or more anchors, with each onplant biointegrated to the underlying bone, in order to guide movement of the bones that the onplants

are biointegrated to, to bring bones closer or further apart, for the correction of bone deformities.

The onplant may have as screw hole penetrating it for the sole purpose of stabilizing it with a small screw into the bone while the onplant is integrating. The screw would serve no purpose once integration had occurred and may be removed when the surgeon exposes the onplant to attach the intended device.

The invention accordingly comprises the several steps and the relation of one or more of such steps with respect to each of the others, and the apparatus embodying features of construction, combinations of elements and arrangements of parts which ar^e adapted to effect such steps, all as exemplified in the following detailed disclosure, and the scope of the invention will be indicated in the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be better understood and the objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein:

FIGURE 1 is a perspective view of the orthodontic anchor system of the invention;

FIGURE 2 is an exploded side elevation view of the invention of FIGURE 1;

FIGURE 3 is a top view of the invention of FIGURE 1;

FIGURE 4 is a bottom view of FIGURE 1 ,

FIGURE 5 is a bottom view of an alternative embodiment of the orthodontic anchor system of the invention;

FIGURE 6 is a bottom view of an alternative embodiment of the orthodontic anchor system of the invention;

FIGURE 7 is a bottom view with the orthodontic anchor system installed in the roof of a mouth with the palatal wire connected to two banded teeth;

FIGURE 8 is a bottom view with another orthodontic anchor system installed in the roof of a mouth with the palatal bar connected to two banded teeth. FIGURE 9 is a human skull with the prosthetic bone anchor system of the invention;

FIGURE 10 is the mandible or lower jaw shown in FIGURE 9;

FIGURE 11 is a cross-sectional view taken on lines 11-11 of FIGURE 10;

FIGURE 12 is a partial cross-sectional view of the upper jaw of a living person;

FIGURE 13 is a crosε-sectional of a tibia or leg bone showing an orthopedic anchor system of the invention;

FIGURE 14 is a finger bone with orthopedic anchor system of the invention; and,

FIGURE 15 is a rib bone with orthopedic anchor system of the invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The orthodontic anchor system 20 has two parts; the onplant 21 and the abutment 22. These are connected to a palatal bar 24 or palatal wire 28, which is attached to bands 25 around the teeth to be held immobile.

As show in FIGURES 1-4 the onplant 21 has an circular upper surface which is the onplant bone interface 30. The circular shape is illustrative only. The onplant may be an oval, a square, a rectangle, a triangle, or other shape to resist the forces applied to it. This onplant bone interface 30 is textured, which both increases the surface area and present's surface area which is better able to resist the shear forces imposed by the orthodontic anchor system 20. Both the textured onplant bone interface 30 and the surface 31 may be covered with hydroxylapatite or other bioactive material.

The onplant 21 has a lower surface with a beveled outer portion 31 and a central circular portion 36. The outer portion 31 joins the outer periphery of the onplant bone interface 30. The center of the lower surface 36 has at least one threaded aperture 32. There may be more than one threaded aperture depending on the need to resist rotational forces. When the onplant 21 is initially installed the threaded aperture 32 has a healing screw 26, not shown, installed to prevent tissue from covering it and having to be removed.

The abutment 22 is circular, with an upper surface 37 matching the lower surface 36 of the onplant 21. The upper surface 37 has a protruding threaded screw 33 which cooperates with the threaded aperture 32. The abutment 22 has a neck 34 of reduced diameter and a head 35 of increased diameter, compared with the neck 34. Surface 35 as shown is illustrative only. It may have a slot, hexagonal, or threaded hole or other means of seating the abutment or attaching the palatal bar.

The dimensions of the onplant 21 may be 8 mm in diameter and 2 mm thickness. The abutment 22 may be 4 mm in overall height, with the neck 34 being 1 mm in height and 1 mm in diameter. The device will vary in size according to the shape and the designed force load. The structure of both the onplant 21 and the abutment 22 is a titanium alloy. The surface, except for the onplant bone interface 30, is smooth and all corners are beveled to prevent damage to soft tissue. The test sample had a 50 micron coating of hydroxylapatite. It was plasma sprayed on the metal. The spray consists of a superheated solution of hydroxylapatite applied to the roughened titanium alloy. FIGURE 5 shows a onplant 21 which is similar to the onplant 21 of FIGURE 1. This onplant 21 is generally cylindrical in shape. It has the onplant bone interface 30 which is textured and coated by hydroxylapatite, and a threaded aperture 32.

FIGURE 6 is similar to FIGURE 5, but is oval in shape and has two threaded apertures 32. This embodiment permits two orthodontic devices to be used.

As shown in FIGURE 7 the palatal wire 28 is soldered to the two bands 25 of two molars or other teeth and presses into the neck 34 of the abutment 22, preventing the two teeth from moving forward. This palatal wire 28 may be fabricated from 0.051 in. orthodontic wire or cast from precious or non-precious metals.

FIGURE 8 shows the orthodontic anchor system 20 mounted between the two teeth to be held stable. The palatal bar 24 is fabricated from thicker metal to resist the shear forces of the teeth against the orthodontic anchor system 20. This palatal bar 24 is screwed on abutment 22 which is screwed into the onplant 21.

The orthodontic anchor system 20 is able to resist both primary lateral and horizontal forces as well as a vertical force.

The orthodontic anchor system 20 is not limited to use with a palatal bar 24. It may alternatively be used with any conventional orthodontic device, as will be immediately apparent. It is within the scope of the invention to use other suitable materials for the orthodontic anchor system 20. These will include inert metals, plastics and composites. Likewise the bonding means can be any mechanical means such as keylocks or miters or magnetic or biodegradable polymer. The onplant bone interface 30 may have a different textured surface or a non-textured surface which promotes adequate bonding strength. The thickness and method of applying the hydroxylapatite"coating may be varied. The orthodontic anchor ε -stem 20 is installed into a patient's mouth in accordance with the following procedures. These are generalized for an understanding of the invention, and are not the detailed procedures which would be actually followed by a surgeon. Under local anaesthesia, an anterior palatal incision will be made and a subperiosteal tunnel created so that the tunnel will place the onplant at the proposed location (most likely between tne permanent first molars) . Conservative dissection will be used in order that palatal reflection is minimal and restricted to only the onplant site in order to prevent onplant migration. One or two onplants will be placed depending on the treatment needs for the patient. For orthopedic applications, the anchor wil] be placed into a subperiosteal tunnel and if placed on a curved surface retained in position during biointegration by a small screw or circumferential resorbable sutures.

For prosthetic or extended applications, an incision will be made along the crest of the alveolar bone, and the periosteum will be reflected. A precision bur may be used to create an optional shallow depression identical

to the shape of the anchor, to the depth required so the anchor lies flush with the bone.

Previous experience indicates that careful surgical technique will result in secure positioning of these onplantε, without the need for retentive wires to maintain bone contact on flat surfaces. However, on curve surfaces a small screw or suture may be needed to retain the onplant in the preferred position during biointegration. The onplant is usually provided sterile by the manufacturer. It will be placed into the subperiosteal tunnel taking great care to place it directly against the palatal or other bone, or into the shallow'depression within the bone. The incision will be closed using 4-0 polyglactin suture. The patients will be given a prescription for antibiotics (typically penicillin or doxyclycline) and analgesics. This small surgical procedure should cause minimal pain to the patient. The patient will be called at home by the surgeon for follow up, and seen for suture removal one week after the surgery. The patient will be followed every two weeks for observation during the healing period which is necessary to achieve integration of the onplants hydroxylapatite surface with the underlying bone. Twelve weeks will be allowed for healing and biointegration to occur. Twelve weeks is the expected onplant biointegration time because that is the time required for integration of hydroxylapatite coated implants in humans. At twelve weeks, the patients will be given local anaestheεia and a εmall incision will be made directly over the onplant, exposing only the healing screw 26 that was placed into the internal thread of each device. An abutment 22 is then screwed into the onplant. The overlying soft tisεue thickness may be thinned to 3 mm in order to allow for cleaning of the attachment device. An impression will be taken in order

to fabricate a palatal bar 24 which is secured to the onplant and banded to the dentition, or to fabricate the mechanical orthopedic or prosthetic anchorage devices depending on patient needs. The palatal wire 28 will be solid and minimally pliable. The wire will be soldered to bands glued to the anchor teeth. Approximately two weeks will be allowed for fabrication of the bar or bending the wire on a transferred study model. The wire will be fabricated of 0.051 in. orthodontic wire.

Two weeks later, orthodontic devices will be attached to the onplant and to the maxillary teeth, for example the first molar, placed in such a way that the wire attaching the onplant to the tooth acts to hold the tooth in position, as an anchor. The onplant will serve as the point of absolute anchorage, preventing the anchored teeth from moving anteriorly.

The remaining dentition will be treated with conventional orthodontic appliances. The location of the teeth with respect to the onplantε may be measured and recorded both by radiographs and actual physical measurement with a Boley gauge.

At the conclusion of the treatment involving the device, under local anestheεia, an incision will be made exposing the entire onplant. Uεing a forcep designed for this procedure, the hydroxylapatite coated device will be removed. The prosthetic device will be left in place to provide anchorage of the denture.

In a study investigating the difference between diameter and length on the ultimate pull-out strength of hydroxylapatite coated cylinders in the dog jaw, a mechanically significant bonding was found with hydroxylapatite coated implants. In the dog alveolus in a cortical and cancellous bone environment, up to 4b poundε were required to pull hydroxylapatite coated onplants from the dog jaw. Based on these mechanical

studies of onplants, we are confident that the onplant'ε hydroxylapatite bone bond can withstand continuously applied forces.

Hydroxylapatite coated implants can be used for restoration of partially and totally edentulous patients. Occlusal function has not resulted in losε of the hydroxylapatite coating, thus continuous occlusal function helps confirm our belief that a hydroxylapatite coated device can function under continuous load. To further verify this concept, clinical trials of uεing hydroxylapatite coated dental implants as orthodontic anchor systems 20 (Hoffman, Block personal communication, 1989) demonstrate that one or two hydroxylapatite coated implantε placed within the bone of the maxilla or mandible can be uεed aε anchors for tooth movement. Teeth attached to the implantε did not move whereaε thoεe teeth not attached to the implantε moved noticeably when εubjected to a εimilar force. Both in animal εtudieε and in theεe clinical trials, these implants did not move, rather the teeth were moved when constant forces in excess of 11 ounces were continuously placed on the implants.

The invention may be used as an anchor for dental prostheses. FIGURE 9 shows a skull of an older male who has lost his teeth, and whose jawbone has partially atrophied. FIGURE 10 showε the mandible of the εkull with four onplantε 21 attached. FIGURE 11 εhowε the onplant shaped to the surface contour of the mandible bone. It discloseε a integration εtabilization εcrew 30 which may be used while biointegration occurs. On a curved surface drifting or lack of intimate contact may require this small retaing screw during the biointegration procesε. The screw serves no other purpose than to stabilize the onplant during this process and may be removed after biointegration.

FIGURE 12 εhows the upper jawbone of a living person between the gingiva or gum and the maxillary sinuε. The loεs of teeth atrophies the bone, often making the known implants impossible to use because of the thinness of the upper jawbone. An onplant 21 is shown biointegrated to the upper jawbone.

The εurface of the onplant which will reεt againεt the bone may be textured, as shown, to increase the surface and resiεt εhear forces. This is not neceεεary as a smooth surface which biointegrates with εufficient εtrength may alεo be uεed. That εurface of the onplant, if an inactive metal, muεt be covered with a bioactive material, εuch aε hydroxylapatite, to promote - biointegration. If the onplant iε itεelf bioactive, such as a plastic or collagen, then the additional coating with a bioactive material may be unnecessary.

For the prosthetic application, an incision is made along the crest of the alveolar bone and the periosteum is reflected. The surface of the onplant which will reεt against the bone is shaped to the contour of the bone. The onplant may be held firmly against the bone by the use of small sorbable screws. A shallow depression may be cut in the bone to allow the onplant to lie fluεh with the surface of the bone. The εurface of the onplant opposite the εurface facing the bone will have means 25 to attach any of the current conventional dental protheseε, including dentureε. Thiε meanε may be, for instance, a ball, a ring, or a magnet, which will cooperate with the mounting on the prostheεis to stabilize the prosthesis.

The invention may be used aε an anchor for an orthopedic device in order to guide the movement of boneε to bring them either closer together or further apart, for the correction of bone deformities or injuries. Onplants 21 are placed in subperiosteal tunnels in two or more bones. The onplant 21 may have to be shaped

to either a convex shape to fit a tibia bone, see FIGURE

13, or a concave εhape to fit a finger bone, εee FIGURE

14. In certain cases, such as the finger bone, the onplant could be held in place during biointegration by sutures or the aformational integration stabilization screws.

After biointegration, orthopedic devices are attached to two or more onplants on different bones in tension or compreεεion, to tranεmit attractive or distractive forceε for bone reconεtruction.

Alternatively the onplant 21, εuch as that on a finger bone, aε in FIGURE 14, could be used aε a prosthetic anchor for an artificial finger tip. ^v

The invention may be uεed to attach a medical device. FIGURE 15 εhows an onplant 21 on a rib bone. A pacemaker may be attached to it, which would provide a more stable mounting than is conventionally used today.

This invention may also have εimilar application in veterinary medicine. It will thuε be εeen that the objects set forth above,among thoεe made apparent from the preceding description, are efficiently attained and, since certain changes may be made in carrying out the above method and in the article set forth without departing from the εpirit and scope of the invention, it is intended that all matter contained in the above deεcription and εhown in the accompanying drawingε εhall be interpreted aε illuεtrative and not in a limiting εenεe.

It iε alεo to be underεtood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statementε of the εcope of the invention which, as a matter of language, might be said to fall therebetween.