DEFICIENCIES

RELATED APPLICATIONS

[01] The present invention claims priority to U,S, Provisional Application

62/641 ,378, filed 03-11-2018; and further claims priority to U S. Provisional

Application 62/682,354, filed 06-08-2018; both of which are incorporated herein by reference.

FIELD OF THE INVENTION

m The present invention is directed to the field of orthodontics and the use of skeletal anchorage devices. The present invention is also directed to a system, components and methods that enable forward advancement and growth of the maxilla and other skeletal bones coupled to the maxilla. The present invention in further directed to skeletal anchorage devices for treating maxillary deficiency and craniofacial dystrophy.

BACKGROUND

[03] Traditional orthodontics focuses primarily on straightening misaligned teeth.

The main goal is to create a great smile with perfect tooth alignment and proper bite. Braces and wires are the preferred way of aligning the teeth.

[04] Other areas of orthodontics are directed to achieving good jaw alignmen in children. These area encompass modification and movement of the bones that support the teeth to attain desirable changes In their relative position so that aesthetics, function, and oral health are improved. Treatments are centered on bone movement rather than tooth movement and address the underlying causes of bad bites and misaligned teeth by utilizing fixed or removable dental appliances, as opposed to braces. Tooth alignment may be done later, if desired, with braces or with non-brace aligners. If begun at an early age, modification and movement of bones can obviate the need for the extraction of adult teeth or jaw surgery, and minimize or completely eliminate the need for fixed braces during adolescence. Because the bone structures of adults are fully formed, dental appliances are not well suite for Jaw alignment in adults. m Craniofacial dystrophy and maxillary hypoplasia are a type of malocclusion, which is a facial growth pattern characterized by deficient jaw growth that results in excessive vertical and lack of horizontal growth of the jaws and that that give the appearance of a long face with a wea chin. Treatments for craniofacial dystrophy include plastic surgery and movement of the teeth. Detractors of these treatments suggest that it merely masks the craniofacial dystrophy without addressing the underlying improperly formed facial bone structure. Other treatments rely on very Invasive and complicated intra-orai prone surgeries that require cutting and grafting of bones.

[OS] Recently, fixed and removable appliances, for example, Biobloc, acrylic

expander, facemask, Bollards, have been developed for orthotropic treatment of Class 111 adul malocclusion. For example, a device known as the Ke!es Facemask (see Fig. 11) includes a palatal expander and an orthodontic face bow, both of which attach to mola bands that are fixed to a patients dentition, The application of external forces via the face bow to the molars is used to create forward movement and growth of the maxilla. However, the ja movement imparted by the Keles device includes a rotational component, which also causes forwardly directed downward growth of the maxilla. St has been identified that the Keles device and similar devices are not the best solution for treatment of craniofacial dystrophy since this for of malocclusion is best treated via non-rotational forward movement and growth to the maxilla and the 9 bones that articulate with the maxilla. The Keles device also relies on tooth borne forces to achieve its movement, which is also less than ideal, since movement that might otherwise be imparted to the maxilla bone is instead imparted to teeth. Another device invented by De Cierck (see Fig 12) is a Bollard miniplate bone anchor that is used to transfer intra-orally generated forces to the maxilla. The Boilard device as well causes forwardly directed downward movement and growth of the maxilla. The Bollard miniplate bone anchor also utilizes a’’one size fits all" approach that does not accurately take into account patient specific features such as bone thickness, craniofacial symmetry, and bone surface area/geometry, which eliminates the ability to optimally place and efinicaily use the device. For example, the Bollard device has a standardized neck length. This standardized length limits its use, where when one end of the Bollard device is attached in the keratinized tissue at or below the mucogingival junction, the location of the opposite end cannot be optimized to account for the particular different skeletal geometries of different patients. Moreover, current marketed devices are all manufactured as a relatively flat surface at their plate end, requiring surgeon to manually manipulate the device to fit to a patient's bone geometry. This approach is flawe in that manually manipulating the minipiate is dependent on clinician's physical skill. Oftentimes, the miniplate needs to be manipulated mid-surgery, increasing procedural time and opportunities for adverse events to occur. Additionally, requiring manual manipulation of the bone anchor requires a sacrifice in material properties. That is, stiffen more strong materials cannot be used because of their inability to be manipulated to fit individual patient's bone geometry. Lastly, following manual manipulation of the Bollard device, its material properties can be greatly degraded. As a result, fracture risk and risk of performance failure greatly increases, in fact, the instructions for use of the Bollard miniplate specifically state "bending should be limited to the region between the boles (1) in the minipiate. This bending should not exceed 10 ^* and may only be performed once. Bending of the plate more than 10° and/or repetitive bending may lead to fracture during or after surgery. The angulation between the minipiate and the neck (2) should not be modified in order to ensure good contact between the lower part of the neck and the alveolar bone (3). The round bar should not be bended. Bending of the round bar may lead to fracture during or after surgery." All these limitations do not allow for optimization of the Bollard device installation location, and therefore, limit its potential effective use.

[073 To date, no known systems, components or methods that use protraction force are able to optimally treat craniofacial dystrophy and maxillary hypoplasia in adults, as well as children, without introducing rotation of the maxilla.

SUMMARY

The present invention identifies that in the mouths of normally developed individuals, vector forces applied to the palate by the tongue (see direction of arrows in Fig. 13} causes normal facia! and skeletal growth. The present invention further identifies that in subject's whose skeletal growth is deficient and whose tongue is unable to provide sufficient forces against the palate to effectuate such growth, such as in adults with craniofacial dystrophy, forward and, as may be needed, additional upward facial growth can be engineere via application of extra-ora!ly generated toward or forward and upward directed protraction forces to skeletal anchorage devices (also referred to as bone anchors below) coupled to the maxilla.

COS] Unlike known solutions, the present invention also identifies that individual patients can be provided more optimal clinical outcomes when the shape of their skeletal anchorage devices is customized to their individual and unique bone structure. m Before providing a customized skeletal anchorage device, the present

invention utilizes software analysis of patient specific 3D data/model derived from cone beam computed tomography (CBGT), CAT Scan, or magnetic resonance imaging (MR!). Each patient's bone thickness and geometry is assessed to optimize where one end of the bone anchor is to be attached via bone screw fixation as well as to optimize the geometry of a mounting plate at the end so that it beneficially exits, keratinized tissue in a manner that minimizes infection. The 3D data/model is also used to customize the geometry of each skeletal anchorage device to match each patient's unique attributes such that It is optimally placed within the patient's mouth to minimize chafing and rubbing as well as to correct placement of its second end so that force(s) applied to the second end do not cause excessive moments at the point to the skull at the other end.

[11] Taken together, this novel approach generates much greater predictability and accuracy in deriving skeletal anchorage, which results in overall greater patient outcomes. mi The present invention’s patient-specific approach enables a plate of each skeletal anchorage device to be attached flush against the patient's bone, and as well allows design a neck of each device with a geometry that enables intraoral neek placement against contours of the jaw. |13J The present invention also enables a customized screw configuration based on the patient's bone geometry, density and thickness. Screw positions in a connecting plate can be optimized to take advantage of skull locations with optimal bone density and thickness, and a force transmitting neck can be designed to attach to the screws in a manner that optimizes force distribution in the screw, thereb reducing the stress concentrations on the screws, enabling more effective and capable orthodontic treatment and procedures. Thi approach promotes better osseointegration, minimizes complications, involves greater predictability for clinicians, and overall improves performance and patient comfort.

[14] While the present invention is directed to positioning the maxilla via

protraction forces to treat craniofacial dystrophy and maxillary hypoplasia, the scope of the invention anticipates its possible use as a patient-specific mandibular anchor for mandibular repositioning, namely, encouraging mandibular forward positioning. Accordingly, the present invention contemplates that it can also more broadly be used for dentofacial orthopedics,

[15J in one embodiment, the present invention comprises a system to treat

maxillary deficiency, the system comprising: an orthodontic face bow comprising an intra-oral portion; and an extra-oral portion, wherein the extra-ora! portion is configured to receive one or more extra-oral protraction force, and wherein the intraoral portion comprises one or more coupler configured to transfer the one or more extra-oral protraction force to intra-oral portions of the patient's mouth that are not teeth of the patient. In one embodiment, the faoe bo consists of The one or more coupler. In one embodiment, the one or more coupler comprises a bone anchor in one embodiment, the intra-oral portions of the patient's mouth that are not teeth comprise maxilla of the patient In one embodiment, the intra-oral end comprises silicone, plastic, acrylic, polymer, or combination thereof. In one embodiment, the intra-oral portions of the patient's mouth that are not teeth comprise a maxilla. In one embodiment, the present invention comprises one or more protraction device configured to apply the one o more extra-oral force

[1b] In one embodiment, the present invention comprises a system for treating a maxillary deficiency of a subject comprised of a first face bow comprised of an Inira oral-end; and an extra-ora! end, wherein the extra-oral end is configured to receive a first force, and wherein the intra-oral en is configured to transfer the first force to a maxilla of the subject; and a second faee bow, comprised of an infra oral-end; and an extra-oral end, wherein the extra-oral end is configured to receive a second force, and wherein the intra-orai end is configured to transfer the second force to the subject's maxilia In one embodiment, the invention comprises an externa! protraction device, wherein the external protraction device is configured to apply the first force to the extra-oral end of the first face bow an to apply the second force to the extra-oral end of the second face bow. i In one embodiment, the present invention comprises: a kit for treating a

maxillary deficiency of a subject, the kit comprising: a container; at (east one bone anchor, wherein the container is configured to store the at least one bone anchor, wherein the at least one bone anchor is configured to transfer extra-oral forces to non-dental portions of the patient’s mouth in one embodiment the kit further comprises at least one coupler, the at leas! coupler comprised of a first end and a second end, wherein the first end is configured to be coupled to a first face bow, and wherein the second end is configured to be coupled to the bone anchor. In one embodiment the kit further comprises a second face bow configured to transfer extra-oral forces directly to the subject's maxillary tuberosity or superior palate. In one embodiment the kit further comprises comprising at least one screw type fastener configured to atach the at least one bone anchor to the non-dental portions of the patient's mouth. In one embodiment, the at least one bone anchor comprises grade 4 or grade 5 titanium. In one embodiment, the at least one bone anchor is printed from eta!.

[183 in one embodiment, the present invention comprises: a bone anchor for

transferring an extra-oral force to a subject's skull, comprising; a first end and a second end, wherein the second en is configured to be intra-oraiiy coupled to the skull, wherein the first end comprises a first coupler, and where the first coupler is configured to be coupled to a force generated from outside the subject’s mouth in one embodiment the bone anchor comprises comprising a connecting piece defined by a length disposed between the first end and the second end. In one embodiment, the second end comprises a plate within which a plurality of apertures are disposed in one embodiment, the plate comprises norvpisnar surfaces configured to fit against non-planar surfaces of the subject's skull. In one embodiment, the plurality of apertures consists of four apertures. In one embodiment, the plurality of apertures consist of at least four apertures wherein, relative to an axis defined by or extending fro the length, an equal number of the apertures are disposed on opposite sides of the axis. In one embodiment, the first coupler comprises an aperture or protrusion configured to be coupled to a second coupler or to an end of a face bow. In one embodiment, the bone anchor comprises Titanium 4 or Titaniu 5. in one

embodiment, the bone anchor is a printed from metal. In one embodiment, when viewed in a cross-section, the connecting piece comprises one or more of a flat, rounded, and a curved surface in one embodiment, the first coupler comprises a cylinder. m In one embodiment, the present invention comprises a system for transferring an extra-oral force to a maxilla of a subject, the system comprising; a first part and a second part, wherein the second part is coupled to the first part, wherein the first part is configured to receive the extra-oral force and transfer the extra-oral force to the second part, and wherein the second part is configured to transfer the force to the subject's maxilla. In one embodiment, the first part comprises a coupler. In one embodiment, the second part comprises a bone anchor.

[20] In one embodiment, the present invention comprises a third part, wherein the first part is coupled to the third part between the first part and the second part, and wherein the third part is configured to receive the extra-oral force from outside the subject's body and to transfer the extra-oral force to the second part In one embodiment, the third part comprises a face bow, wherein the face bow comprises a first end configured to be coupled to the coupler, in one embodiment, the bone anchor comprises Titaniu 4 or Titanium 5. In one embodiment, the bone anchor is a printed from metal. In one embodiment, the first part and the second part are connected by a connecting piece, wherein when viewed in a cross-section, the connecting piece comprises one or more of a flat, rounded, and a curved surface. [21] In one embodiment, the present invention comprises a method of treating maxillary deficiencies, comprising the steps of: intra-oraliy attaching at least two bone anchors to locations on the maxilla of a subject; coupling first ends of a face bow to the two bone anchors; and applying extra-oral force to the face bow. In one embodiment, the method comprises applying the extra-oral force that does not cause rotation of the maxilla about the at least two bone anchors. In one embodiment, with the subject standing and with the head of the subject facing forward, the extra-oral force is applied to the face bow only in a forward of a combination of forward and upward direction, In one embodiment, the bone anchor is not attached to any other intra-ora! structure within the subject's mouth. In one embodiment, application of the extra-oral forces does not cause rotational moments to be generated at the two bone anchors. In one embodiment, the extra-oral force is applied to the face bo along a vector that passes through the face bow where the force is applied and the two bone anchors.

[22] In one embodiment, the present invention comprises a method of treating a subject, comprising the steps of; intra-oraliy coupling a first end of face bow to the maxilla of the subject; and applying an extra-oral force to a second end of the face bow to cause the maxilla of the subject to move substantially forward without any downward rotation. In one embodiment, the first end of the face bow is coupled to the zygomatic buttress or the infrazygomatic crest of the subject in one

embodiment, the face bow is not attached to any of the teeth of the subject.

[23 in one embodiment, the present invention comprises a method of causing a maxilla to grow via an application of a force, comprising the steps of: intra-oraliy coupling at least one bone anchor to the maxilla; generating an extra oral force; and coupling the extra-oral force to the at least one bone anchor to cause the maxilla to move forward without any downwar rotation. In one embodiment, the foree is coup!ed to the at least one bone anchor via a face bow. in one embodiment, the at least one bone anchor comprise two bones anchors wherein each respective bone anchor is coupled to the maxilla on a respective opposite side of the maxilla in one embodiment no other forces other than the extra-oral force are coupled to the at least one bone anchor, [24] In one embodiment, the present invention comprises a method! for treating a subject, comprising the steps of: generating an extra-oral force; attaching at least one bone anchor to a maxilla of the subject; and coupling the extra-oral force to the at least one bone anchor to cause movement of maxilla and without causing moments to be generated at the at least one bone anchor.

[25] In one embodiment, the present invention comprises A method of treating a subject, comprising the steps of: generating an extra-oral force; attaching at least bone anchor to a maxilla of the subject; and coupling the extra-oral force to the at least one bone anchor to non-rotaiionaliy move the maxillary complex of the subject about the at least one bone anchor.

[26] In one embodiment, the present invention comprises a method of treating a subject for cranial dystrophy and deficiency comprising the steps of: generating an extra-oral force; attaching at least one bone anchor to a maxilla of the subject; and coupling the extra-oral force to the at least bone anchor to cause the maxillary complex of the subject to move in a direction that is not directed downward relative to a forward facing direction of the subject's face.

[27] In one embodiment, the present invention comprises a method of treating a subject, comprising the steps of: attaching at least one skeletal anchorage device to a maxilla of the subject at an attachment point; and applying an extra oral force to the skeletal anchorage device, where the extra-oral force creates substantially no moment about the attachment point.

[28] in one embodiment, the present invention comprises at least one face bow, comprising infra oral-ends; and at least one pair of extra-oral ends coupled to the intra-oral ends, wherein the extra-oral ends are configured to receive extra-ora! forces, and wherein the intra-oral ends are configured to transfer the extra-oral forces to the interior of a subject's mouth without contacting the subject’s teeth. In one embodiment, the at least one face bow comprises two face bows. In one embodiment, the intra-oral ends are configured to transfer the extra-oral forces to the maxilla of the subject. In one embodiment, the intra-oral ends are configured to transfer the forces to a palate of the subject. [29] In one embodiment, the present invention comprises a bone anchorage

device for the attachment of orthodontic appliances, comprising : a first end and a second end, wherein the second en is configured to be directly coupled to an intra- oral location on the jaw of a subject, wherein the first end comprises a first coupler configured to be coupled to an orthodontic appliance inside or outside the subject's mouth; and a connecting piece with a length connecting the first end and the second end, wherein the length is comprised of one or more of a straight, bent, curved, and/or twisted portion in one embodiment, the length is defined by one or more cross-sectional shape comprised of at least one rounded, elliptical, semicircular, curved or flat side, In one embodiment, the one or more cross-sectional shape comprises two or more of a rounded, elliptical, semicircular, curved or flat side in one embodiment, the second end comprises a plate within which a plurality of apertures are disposed in one embodiment, the plate comprises a surface, wherein the surface is non-planar; and wherein a substantial portion of the non-planar surface is configured to conform to a substantial portion of a surface of the jaw. In one embodiment, the first coup!er comprises an_attachment_point. in one

embodiment, the attachment point comprises an aperture. In one embodiment, the plate comprises a left and right portion, wherein the left and right portion each comprise at least two apertures, wherein the apertures in the left portion are disposed along an axis that is generally slanted with respect to an axis of the connecting piece at its connection to the plate, and wherein the apertures in the right portion are disposed along an axis that is generally parallel with respect to the axis of the connecting piece at its connection to the plate in one embodiment, the plate comprises a left and right portion, wherein the left and right portion each comprise at least two apertures, wherein the apertures in the right portion are disposed along an axis that is generally slanted with respect to an axis of the connecting piece at its connection to the plate, and wherein the apertures in the left portion are dispose along an axis that is generally parallel with respect to the axis of the connecting piece at its connection to the plate. In one embodiment, the plate comprises a left and right portion, wherein the left and right portion each comprise two apertures, and wherein the apertures are disposed asymmetrically with respect to each other in one embodiment, the plate comprises a left and right portion, wherein the left and right portion each comprise two apertures, and wherein the apertures are disposed symmetrically about an axis defined by the connecting piece. In one embodiment, the location on the jaw comprises a location on a zygomaticomaxillary buttress or the mandible in one embodiment, the location on the jaw comprises a location on a nasomaxillary buttress or the mandible. In one embodiment, the location on the jaw comprises a location on a maxillary buttress or the mandible. In one embodiment, the location on the jaw comprises a location on the maxilla or mandible. In one embodiment, the location on the jaw is adjacent a zygomatic suture on the maxilla or on the mandible. In one embodiment, the first coupler comprises an attachment point configured to permit attachment of an orthodontic appliance, in one embodiment, the orthodontic appliance comprises a face bow in one embodiment, the orthodontic appliance comprises a second coupler.

[30] n one embodiment the present invention comprise a method of forming a patient-specific bone anchorage device, comprising the steps of; obtaining a model of a patient's skull or mandible, identifying one or more location on the mode! of the patient's skull or mandible; manipulating the mode! of the bone anchorage device to cause a shape of the bone anchorage device to fit against the one or more location on the model of the patient’s skull or mandible; and positioning the model of a bone anchorage device against the model of the patient's skull or mandible in one embodiment the model of the patient’s skull is a digital model obtained with a digital scanning device, wherein the model of the bone anchorage device is a digital model embodied in code or memory of a computing device; and wherein manipulating the shape of the mode! of the bone anchorage device is performed on the computing device. In one embodiment, the digital model of the patient's skull represents a surface of the skull or mandible. In one embodiment, the digital model of the patient's skull or mandible, and the digital model of the bone anchorage device are displayed on a digital display. In one embodiment, the manipulation of the bone anchorage device comprises lengthening, shortening, contouring, twisting, stretching, and/or bending a connecting piece of the bone anchorage device. In one embodiment, the manipulation of the bone anchorage device comprises changing a contour of a plate at the second top end of the bone anchorage device. In one embodiment, the manipulation of the bone anchorage device comprises changing a thickness of the bone anchorage device. In one embodiment, the manipulation of the bone anchorage device comprises manipulating a first bottom end of the bone anchorage device. In one embodiment, the digital model of the bone anchorage device is stored in a file In one embodiment, the file comprises an STL file. In one embodiment, comprises manufacturing the bone anchorage device based on digital data stored in the file. In one embodiment, manufacturing the bone anchorage device is performed by printing in one embodiment, the bone anchorage device comprises metal. In one embodiment, bone anchorage device comprises titanium 5. In one embodiment, the manipulation comprises twisting, stretching, and or bending one or more portion of the model of the bone anchorage device. In one embodiment, the one or more location comprises a location on a zygomaticomaxillary buttress in one embodiment, the one or more location comprises a location on a nasomaxillary buttress. In one embodiment, the one or more location comprises a location on a maxillary buttress.

In one embodiment, the one or more location is adjacent a zygomatic suture on the maxilla in one embodiment, further comprises a step of using screws to attach the bone anchorage device to a skull or mandible of the patient in one embodiment, the bone anchorage device comprises an atachment plate comprised of screw holes, wherein the manipulation Includes locating the screw holes in the attachment plate such that when mounted to the patient’s skull or mandible by screws inserted within the screw holes and with an external force applied to the bone anchorage device, the external force is distributed to be substantially equal among the screws. In one embodiment, the one or more location comprises a location on the skull mandible that optimizes the force distribution. In one embodiment, the one or more location comprises a location on the e that has a bone thickness and/or density capable of optimizing the force distribution. In one embodiment, the one or more location is identified by a person performing the method. In one embodiment, the one or more location is identified using artificial intelligence.

[31] In one embodiment, the present invention comprises; a method of using a patient-specific bone anchorage device, comprising the steps of: identifying one or more location adjacent to a zygomatic suture of a patient; manipulating a shape of the bone anchorage device to cause the shape to fit against the patient’s skull in the area of the zygomatic suture; attaching the bone anchorage device to the one or more location. In one embodiment, the present invention further comprises applying an extra-oral force to the bone anchorage device, in one embodiment, the present invention comprises applying the extra-oral force to the bone anchorage device with little or no rotational moment created at the bone anchorage device by the extra-oral force.

[323 Other embodiments, aspects, and benefits of the present invention wifi thus become apparent upon a further reading of the detailed description beiow.

FIGURES

£33] Referring to Fig, 1 , there is seen a representation of a system used for

engineering facial and skeletal growth.

[34] Referring to Figs. 2a-d, there are seen top, front, side and perspective

representations of an embodiment of a first face bow and a second face bow.

[38] Referring to Fig. 3, there is seen a representation of an embodiment of a first face bow couple to orthodontic headgear.

[38] Referring to Figs. 4a-e, there are seen top, front, side and perspective

representations of an embodiment of a bone anchor.

[37] Referring to Fig. 5, there are seen top, a front, and perspective

representations of an embodiment of a coupler,

[38] With reference to Fig. 6, there is seen another embodiment of a first face bow.

[39] With reference to the representations in Figs. 7a-f, methods of use of a first face bow and bone anchor are referenced.

[40] With reference to Figs. 8a~d, there are seen representations of top, front, side, and perspective and views of an embodiment of the second face bow shown partially in Fig. 3 and more fully in Fig. 1.

[41] Referring to Figs. 9a-b, there are seen representations of top and side views of another embodiment a second face bow. [42] Referring to Fig. 10, there is seen a representation of application of horizontal and upward forces by a second face bow to a maxilla of a subject

[43] Referring to Fig. 11 , there is seen a prior art device.

[44] Referring to Fig. 12, there is seen a prior art device.

[45] Referring to Fig. 13, there are seen a representations of a bone screw,

[46] Referring to Fig. 14, there is seen a representation of forces applied to the palate by the tongue.

[47] Referring to Figs. 15a-b, there are seen representations of embodiments of a bone anchor.

[48] Referring to Fig. 16, there is seen another representation of a bone anchor embodiment. 4$3 Referring to Fig . 17, there are seen virtual representations of a bone anchor.

[50] Referring to Fig. 18, there is seen a representation of the location of a

zygomatic maxillary suture.

[51] Referring to Fig. 19, there is seen a representation of a human skull

[52] Referring to Fig, 20, there is seen a representation of an embodiment of a bone anchor.

[53] With reference to Fig. 21 , there is seen a representation of the anatomy of a skull.

[54] With reference to Figs. 22a-b, there are seen embodiments of customized bone anchors.

[55] With reference to Fig. 23, there is seen a representation of a perspective view of an orthodontic device that is capable of providing intra-oral maxillary expansion. m With reference to Fig. 24, there is seen a representation of an orthodontic device that is capable of providing both maxillary protraction and intra-oral maxillary expansion.

[67] With reference to Figs. 25a-b, there is seen a representation of an orthodontic device that is capable of providing maxillary protraction and treating transverse craniofacial asymmetry

[68] With reference to Figs. 2Sa-c, there is seen a representation of an orthodontic device that is capable of providing maxillary protraction and treating transverse craniofacial asymmetry in use.

[68] With reference to Fig. 27, there is seen an illustration of a force diagram

showing the forces generated by the orthodontic device including a facebew coupled to a lateral attachment portion.

[SO] With reference to Fig. 28, there is seen the calculations used to determine the forces generated by the orthodontic device including a facebow coupled to a lateral attachment portion.

DETAILED DESCRIPTION

[61] Referring to Fig. 1 , there is seen a representation of a system used for

engineering facial and skeletal growth as is needed to treat maxillary deficiencies, craniofacial dystrophy and maxillary hypoplasia via direct application and transfer of extra-oral protraction forces to a maxilla of a subject. In one embodiment, the system comprises; first face bow 102, second face bow 106, two bone anchors 110 (one which is not visible on the opposite side of the skull in Fig. 1), and two couplers 114 (one which is not visible on the opposite side of the skull in Fig . 1). As will be appreciated upon a reading of the descriptions provided below, to achieve beneficial facia! growth of the maxilla, the first face bow 102 can be used alone, the second face bow 102 can be used alone, or both the first and second face bow can be used In combination.

[62] Referring to Figs. 2a-d, there are seen top, front, side and perspective

representations of an embodiment of a first face bow and a second face bow. In one embodiment, a first face bow 202 comprises first ends 203 configured to be inserted into the ora! cavity of a subject and second ends 204 configured to be coupled extra- oraily to headgear (see Fig. 3} worn by a subject. The embodiment in Fig. 2 represents the second ends 204 being comprised of a loop, however, other geometries for the second ends are considered to be within the scope of the invention as long as such geometries enable the second ends to be coupled to an extra-oral headgear or other external structure capable of applying extra-oral forces to the second ends in one embodiment, the first face bow 202 comprises 304V stainless steel and the exemplary dimensions shown in Fig. 2, however, other materials, geometries and other dimensions are within the scope of the invention as long as they are compatible for human use and are configured to transfer extra-oral protraction forces applied at the first ends 203 to the second ends 204 in the manner described further below.

Referring to Fig. 3, there is seen a representation of an embodiment of a first: face bow coupled to orthodontic headgear in one embodiment, first a first face bo 302 is coupled to a headgear 390 that acts as an anchor to for extra-oral protraction forces that are applied to the first face bow, which in turn transfers the extra-oral protraction forces to intra-oraliy mounted bone anchor 310. in one embodiment, headgear 390 is used in conjunction with a plurality of elastics 391 that generate the extra-oral protraction forces applied to the face bows in other embodiments, it is contemplated that protraction forces can be provided by springs, wires or other means capable of applying tension forces to the face bows in embodiments, the headgear 390 can be made of elastics; plastics, metals, and combinations thereof, however, other materials and geometries are within the scope of the invention as well. In one embodiment, rather than a headgear perse, other protraction devices are also contemplated to be within the scope of the invention, for example, protraction devices that could be anchored on other parts of the subject's body , or off a subject's body in one embodiment, headgear 390 also enables application of extra-oral forces to a second face bow 306, which is represented only in part in Fig,

3 and is described and shown in more detail further below. [64] Referring to Figs. 4a-c there are seen top, front, side and perspective

representations of an embodiment of a bone anchor in one embodiment, a bone anchor 410 comprises a first end 403 configured to be coupled to extra-ora!ly applied protraction forces, and a second end 404 structurally coupied to the first end. In one embodiment, bone anchor 410 comprises a connecting piece 420 that defines a length that couples the first end 403 to the second end 404 and that is configured to transfer forces from the first end to the second end. In one embodiment, the connecting piece comprises a linear portion 430 and a curved portion 440. In one embodiment the second end 404 comprises a plate 421 within which a plurality of apertures 422 are disposed. In one embodiment, apertures 422 are structured to receive bone screws of a type known in the dental surgery arts (for example, as represented in Fig 14) to fixedly couple the plate 421 to an intra-ora i location on the skull via an intraorai tool adapted to facilitate installation of the screws. In one embodiment, the number of apertures is four apertures. As seen in the front view, in one embodiment, relative to a central axis defined by a portion of the connecting piece 420, two apertures 422 are disposed on one side of the axis and 2 apertures are disposed on another side of the axis. As seen in the side view, in one

embodiment, relative to an axis defined by the length of the connecting piece 420, the piste 421 is disposed in a plane that passes along the axis in one embodiment, plate 421 comprises a horizontal portion 423 from which two side portions 424 extend on either side. In one embodiment, two apertures 422 are disposed in the horizontal portion 423, and each side portion 424 is comprised of an aperture 422. In one embodiment, connecting piece 420 connects centrally to the horizontal portion 423 at a connecting portion 426 between each of the two side portions 424 In one embodiment, the connecting portion 426 is disposed centrally with respect to the horizontal portion 423 and equidistant from each of the apertures 422. In another embodiment, with a plate 421 comprising a horizontal portion having a vertical height at the central portion that is smaller or larger than shown in Figs. 4a-c, the

connecting portion 426 could be disposed either higher or lower such that the connecting portion would be disposed centrally on the horizontal portion but not equidistant from each of the apertures (see Fig, 4e). In one embodiment, the first en comprises a coupler 450. In one embodiment, coupler 450 is comprised of an aperture 451. In one embodiment, aperture 451 comprises a holiow cylinder. As seen in the front view in Fig. 4a, aperture 451 defines a central axis that is orthogonal to an axis defined by the connecting piece 420. in one embodiment, bone anchor 410 is manufactured from material having a hardness and or stiffness capable of allowing the shape of the bone anchor to be manually changed. In one example, the material comprises grade titanium and the exemplary dimensions shown in the figures, however, as will be seen from the description, other materials, geometries and dimensions are within the scope of the invention as Song as they are compatible for human use and are sufficiently strong enough to transfer extra-oral protraction forces applied at the first end 403 to the second end 404. Although in an uninstalled configuration bone anchor 410 comprises the particular shape

represented by Figs. 4a~o, to better confor to the shape and geometry of a subject’s intra-oral skeletal structure, in one embodiment, bone anchor 410 is manufactured to be capable of having its shape and geometry manually manipulated to fit a patient’s bone geometry before installation by a clinician.

Referring to Fig. 5, there are seen top, a front, and perspective

representations of an embodiment of a coupler in one embodiment, a coupler 510 comprises a first end 560 configured to be coupled to extra-oraily applied protraction forces and a second end 570 coupled to the first end 500. in one embodiment, coupler 510 comprises a body 562 configured to transfer forces from the first end to the second end. In one embodiment, the body 562 comprises an aperture 563 and a protrusion 564. in one embodiment, the aperture 563 is formed at the first end 560 and the protrusion 564 is formed at the second end 570. In one embodiment, the aperture 563 is configured to receive and to be coupled to a first end 203 of the first face bow 202 shown in Fig. 2. In one embodiment, the aperture 563 Is configured to retain the first end of 203 such that with 200 to 1000 grams of force applied to each anchor via respective first ends 203 of the first face bow, couplers and ends of the face bow remain Joined to each other in one embodiment, second end 570 is configured to keep the first end 403 of the bone anchor 410 shown in Fig , 4 coupled to the second end 570 while an extra-oral force is applied to a second end 204 of the face bow 202 shown in Fig. 2. In one embodiment, protrusion 564 Is configured to slideah!y and removeably fit within aperture 451 of the first end 403 of the bone anchor 410 shown in Fig. 4, m In another embodiment, the second end 570 of the coupler 510 can be

configured to comprise an aperture at the location of the protrusion 564, and the first end 403 of the bone anchor 410 shown in Fig. 4 could be configured to comprise a protrusion at the location of the aperture 451. In one embodiment, coupler 510 is manufactured from nylon and with the exemplary dimensions shown in Fig 5, however, other materials (for example, po!ymers/plastics), geometries and

dimensions are within the scope of the invention as long as they are compatible for human use and are configured to transfer extra-oral forces to the bone anchor in the manner described above and further below.

[67] With reference to Fig. 6, there is seen another embodiment of a first face bow.

In one embodiment, the functionality provided by coupler 510 (see Fig. 5) is provided by an embodiment where the first ends of a first face bow 602 comprise an integral coupler 610. In one embodiment, first face bow 602 comprises ends 611 that are configured to couple to intra-orally installed bone anchor. In one embodiment ends 611 of first face bow 602 comprise a protrusion configured to fit within an

appropriately dimensioned aperture of a first end of a bone anchor. In one

embodiment, the ends 611 comprises a bent curved or hook like geometry formed at the same time as the formation of first face bow 602. Both the embodiment of Fig. 5 and Fig. 6 facilitate simple and quick connection and removal of a first face bow, not just by a dental specialist, but by a subject with the bone anchors installed.

[68] With reference to the representations in Figs 7a~f, methods of use of a first face bow and bone anchor are described below.

[69] In the discussion below, two exemplary examinations of different extra-oral forces as they are applied to a bone anchor via a first face bow are presented, where use of the terms forward horizontal, downward and vertical are used refer to a respective direction and orientation of a subject's skuli when the subject is standing in a prone position with their head facing forward.

[70] Unlike other devices, for example the Keles and De Clerck devices discussed in the background, which apply forces that cause rotation and thus unnatural downward movement and growth of the maxilla, the first face bow of the present invention is directed to treating maxillary deficiency and craniofacial dystrophy via a system, components and methods that, with reference to a standing subject's head facing forward, effectuate substantially only forward movement and growth of the maxilla in one embodiment, the first face bow and bone anchors of the present invention are configured to apply forces to the maxilla that rare uniquely able to generate positive forward growth not just of the maxilla, but as well as of the zygomatic bone and other bones that articulate with movements of the maxilla:

sphenoid, frontal bone, ethmoid, etc.

[711 The present invention identifies that when used with installed bone anchors, first face bow, and external headgear as seen in Fig. 4, the connecting portions 426 of each anchor is preferred to be maintained in the same plane (i,e a horizontal plane when a patient is standing with their face pointing forward) the extra-ora! second ends 204 the first face bow 302 is disposed in (see Fig 3). Why this orientation is preferred is addressed in the examinations made below.

[721 A first examination contemplates application of extra-oral protraction forces to a face bow 702 and couples the forces to a maxilla via a bone anchor 710 at an upward angle relative to a horizontal plane. With reference to Fig. 7a, th forces can be analyzed using the following equations, where along the Y Axis -Fo cos0 +FAY - 0, where FAY is the Y component of FA, where along the Z axis we get ~Fo sin8 +FA2 ~ 0, an where the resulting moment will be = Fo Sin8 * LMY + Fo eosB * Usz. If Fe is approximately 500 g of force (4.9 N) acting at an angle of 30° and U¾Y - 5 cm and LMZ _“ cm, we get the following result: FAY ~ 4 24 N - 432 go force, FAZ ~ 2,45 N ~ 250 g of force and ~ 0,25 Nm.

[73] Using the above, we can estimate the load o screws that will be used to attach the bone anchor to the maxilla from the resulting moment by using the free body diagram shown in Fig, 7b. Assuming Is is approximately 1 cm, we get screw shear forces in excess of the foliowing. Fsi « Fsz = 25N - 2500 g of feree. This result reflects a balancing the moment M, which is primarily created by the Z component of FA, combined with the !arge moment arm LMY. The present invention identifies that a similar large moment could be generated by forces directed at a downwar angle relative to a horizontal plane and, that at some value, such moment could be too large for the bone anchor screws and bone structure of the maxilla to handle

[74] In the second exemplary application represented by Fig 7c, and to which an

embodiment of the present invention is directed, extra-oral forces are applied by a face bow 702 to a maxilla horizontally. A similar analysis is performed as for the first application of forces above. With reference to Fig 7c, along Y axis -Fo + FA ~ 0, where Z axis forces are all assumed to be zero, and the resulting moment is M ~ Fo ^* LMZ. If FD is approximately 500 g of force (4,9 N) and LMY ~ 5 cm LMZ“1 cm, we get the following result FD = 500 g of force and M ~ 0,049 Nm, Thus, it is identified that in one embodiment, application of horizontal forces results in reduced moments being applied to the bone anchor screws and maxilla, which preferably reduces bone screw breakage and damage to the maxilla.

[75] With reference to Fig. 7d, a frontal analysis of moment loads about the X axis is represented. In Fig. 7d, FA appears as a force application point that points straight out from the figure. Depending o the application point, there will be a moment arm L X which will create additional moments on the bone anchor. To minimize this additional moment, application point of FA, which corresponds to an end 204 of the face bow in Fig, 2, can be moved to align closer with a vertical plane in which the bone anchor is disposed. To further minimize stresses caused by the moment arm in Fig. 7d, the present invention identifies that a cross screw pattern of the apertures 422 provided on the bone anchor of Fig. 4 can be used minimize loading of the screws by providing equal distribution of forces that are transferred by the bone anchor to the connecting point 426

[76] Use of the present invention contemplates man embodiments. For example, another embodiment of the present invention is directed to application of extra-oral forces to the maxilla of a subject with a configuration that is Intended to achieve optima! treatment of maxillary deficiency and craniofacial dystrophy. Further, one embodiment of the present invention is directed to application of extra-oral forces to the maxilla of a subject with a configuration that causes the maxilla and the bones that articulate with it to move and grow in a manne that achieves optimal treatment of maxillary deficiencies and craniofacial dystrophy. Also, one embodiment of the present invention is directed to application of extra-oral forces to an installed bone anchor with an orientation relative to the skull that causes no rotation or substantially no rotation at the bone anchor. Also, one embodiment of the present invention is directed to application of extra-oral forces to the maxilla of a subject with an orientation relative to the skull that causes no rotation or substantially no rotation of the maxilla about the bone anchor. Also, one embodiment of the present invention is directed to application of extra-oral forces to the maxilla with an orientation relative to the skull that causes no rotation or substantially no rotation of the bones that articulate with the maxilla about the bone anchor. In other embodiments, the present invention identifies that because rotational moments applied to bone anchor screws cart be minimized, stresses applied to the bone anchor and bone anchors screws can minimized, where such minimization can be achieved when protraction forces applied to a face bow are applied at the face bow along a vector that passes through the plates of the bone anchors, fo example In a forwardly directed upward direction as represented by Fig. 7e or a forward only direction as represented by Fig. 7f.

In embodiments, the zygomatic buttress of the maxilla and the infrazygomatic crest are Identified by the present invention to be locations on the skull that are well suited for attaching bone anchors to achieve the benefits of the present invention, however, other attachment points are also within the scope of the invention, as long as the bone anchors and face bow are able to be dimensioned to ai!ow application of forward or a combination of forward and upward vector extra-oral protraction vector forces in a manner described above and in a manner that interacts minimally with the lips an teeth of a particular subject. For example, in one embodiment it is

contemplated that a bone anchor could be coupled higher on the skull along the zygomatic bone, Flowever, it is identified that attachment to the zygomatic bone may require more invasive surgery, and as well, since the zygomatic bone articulates with significantly fewer bones than the maxilla, results achieved via attachment and application of forces to the zygomatic bone may potentially not be as beneficial to a subject as those that can be achieved via application of forces to the maxilla. Further discussions directed to the selection of locations for the attachment of bone anchors is provided below. [78] Referring to Figs, 8a-d, there are seen representations of top, front, side, and perspective and views of an embodiment of the second face bow shown partially in Fig, 3 and more fully in Fig, 1 , In one embodiment, a second face bow 802

comprises first ends 803 configured to be inserted into the oral cavity of a subject and second 804 and third ends 805 configured to be coupled extra-orally to a headgear or other type of protraction device worn by a subject {see Fig 3, which represents a coupling of third ends of a second face bow to a headgear). Figs 8a~d show the second ends 804 and 805 being comprised of a straight piece and a loop respectively, however, other geometries for the second ends are considered to be within the scope of the invention as long as such geometries enable the ends to be coupled to an extra-oral headgear or other external structure capable of applying extra-oral forces to the ends. In one embodiment the first face bow 902 comprises 304V stainless steel and the exemplary dimensions shown in Figs. 8a-d, however, other materials, geometries and dimensions are within the scope of the invention as long as they are compatible for human use and are configured to transfer extra-oral forces applied at the second 804 and third ends 805 to the first ends 803 in the manner described above and further below.

[79] Referring to Figs. 9a-h, there are seen representations of top and side views of another embodiment a second face bow. As in the embodiment of Figs. 8a~d, a second face bow 902 comprises first ends 903 configured to be inserted into the oral cavity of a subject an second 904 and third ends 905 configured to be coupled extra-orally to a headgear worn by a subject in embodiments, ends 904 and 905 comprises hooks or loops. In one embodiment, the first ends 903 are integrated with a materia! comprised of silicone, or other bio-compatible polymer, plastic or acrylic.

In one embodiment, the material is configured to fit against each side an against the maxilla behind the molars an provide a cushioning fit of the first ends 903 against the maxilla (i.e. see Fig, 1 for the location where intra-oral first ends of a second face bow are disposed) in one embodiment, the locations where first ends 903 are coupled to the maxilla at maxillary tuberosities. In one embodiment, second face bow 902 is configured to receive extra-ora! forces at third ends 905 and transfer the forces intra-orally to the maxilla via the first ends 903. In one embodiment, horizontal or substantially horizontal extra-ora! forces are applied to second face bow S02 with respect to the skull of a prone subject such that when inserted and coupled to the maxiSia, a first end 903 of the second face bow 902 and the point where extra- ora! forces are applied at a third end 905 are aligned in the same horizontal plane (Le see orientation of second face bow 902 in Fig. 3) !n one embodiment, extra-oral forces are applied to the second face bow 902 by a headgear. Application of extra- ora! forces horizontally to the maxilla via a second face bow 902 can be used to achieve the same benefits as that described above with use of the first face bow but without the intra-ora! surgery needed to attach a bone anchor to the maxilla in an alternative embodiment (see Fig. 9c), it is contemplated that intra-ora! ends of a second face bow as discussed above can be embedded within an acrylic appliance that is configured to fit against the maxilia at superior palate either behind the molars or the maxillary tuberosity.

[SO] Referring to Fig 10, there is seen a representation of application of horizontal and upward forces by a second face bow to a maxilla of a subject. The present invention Identifies that in some individuals, in order to achieve the best overall maxillary and facial bone growth, in addition to the use of horizontal or substantially horizontal forward force vectors to achieve forward growth of the maxilia and skeletal bones coupled to the maxilla, varying degrees of upward force may also be desired to be applied. Although application of upward force could be achieved via a configuration of the first face bow where its extra-oral end is positione in a higher horizontal plane than the bone anchor, as identified above, such an orientation can cause moments to be generated that can cause undesired excessive stresses to be applied to bone anchor screws an thus the maxilia. Reduction of this stress is discussed below.

[81] In one embodiment, a headgear 1090, elastics 1091, first 1003, second 1004, and third 1005 ends of a second face bow 1002 are used to apply both forward forces, as well as forwardly directed upward forces to a subject. With reference to the representations of the first and second face bows in Fig. 3, when horizontal or substantially horizontal forces are applied directly to bone anchors by a first face bow alone, it is identified that the forces need to fight against the resistance of ail the bones coupled to, and that articulate with, the maxiiia. It is identified that additional application of forward forces to the maxilla by a second face bow (see horizontal orientation of elastic 1091 connected to third end 1005) enables the amount of force applied by the first face bow to he reduced, which can in turn be used to reduce the amount of stress applied to bone screws and the maxilla. The present invention also identifies that although it may not be desired to apply upwardly directed force vectors to the bone anchor, and thus the maxilla, by the first face bow, such forces could also be applied by the second face bow at 1GQ4 (see upward angle of elastic 1091 connected to second end 1004) without causing excessive stresses on bone screws, because the second face bo does not require use of bone screws. Thus it will be appreciated by those skilled in the orthodontic arts that treatment of maxillary deficiency and craniofacial dystrophy by the present invention encompasses not just horizontal or substantially horizontal application of forces to the maxilla, but as needed, varying degrees of upwardly directed forward forces as may be needed to mimic both the beneficial forward as well as upward force production that the tongue applies intra-oraiiy to the structure of the mouth.

[82] The bone anchor described herein is an innovative orthodontic anchor

designed to be used to provide orthodontic maxillary protraction as well as in other orthodontic procedures that require orthodontic anchorage: (molar distalization, for example, or mandibular forward positioning). The device's design is innovative in that it allows optimization of force distributions as well as force vectors. m The present invention further identifies that recent innovations in additive

manufacturing can be used to create customized bone anchors according to information obtained during software analysis of patient specific 3D data/model.

Such a customized approach has several advantages. Namely, it eliminates an installing surgeon fro being having to manually bend bone anchors to fit to a patient’s skeletal structure prior to intra-oral installation, where such manipulation can degrade mechanical properties of the bone anchor and subject it to fracture or maiperformanee, as well as entail uncertainty and time consumption during installation. A consequence of not needing to manually manipulate the bone anchor shape manually is that stiffer materials than otherwise could be used can be considered, which opens up the possibility of other applications for the present

invention,

[84] Referring to Figs. 15a-b, there are seen representations of embodiments of a bone anchor. The bone anchor embodiments of Figs 15a~b have in common with other embodiments describe previously in that they comprise; a top second end 1504 configured to couple extra-oral forces to a patient's maxilla, where the forces are first received at a bottom first end 1503, which is coupled to the top second end 1504 via a connecting piece 1520 that defines a distance that separates the bottom first end and the top second end,

[BSl In the representations of Figs. 15a-b, the top secon en 1504 of each bone anchor 1510 is configured to be attached to a zygomatic buttress of the maxilla, however, it is identified that such attachment may not necessarily be against a completely flat surface. Thus, although the top second end was previously

represented with an initially fiat surface (see Fig, 4 above), to achieve good fitment against the zygomatic buttress, in one embodiment, the top second end 1504 is configured with other than a completely flat surface, for example, in the form of a plate 1521 comprised of contoured surface configured to match a surface of a desired point of attachment against the maxilla.

[88] Referring to Fig. 18, there is seen another representatio of a bone anchor. In one embodiment, reduction in interference with a patient's normal oral functions by a bone anchor 1610 can be achieved by customizing the length and/or geometry of a connecting piece 1820 to comprise one or more of straight, bent, curved, and/or twisted portion. In embodiments, connecting piece 1820 comprises the same or a varying cross-sectional geometry along one or more portions of its length. In embodiments, a surface of bone anchor T81Q at a cross-section taken through bone anchor 1810 comprises one or more of a generally round, elliptical, semicircular, curved and flat side. For example, in one embodiment, a top portion 1620a of connecting piece 1820 comprises a surface comprised of cross-sections having areas defined by at least one flat or curved side and a rounded side, a middle portion 1820b that comprises a twisted and curved surface comprised of smaller cross- sectional areas than at the top portion and that are defined by at least one flat side or curved side and a rounded side, and a bottom portion 1620c that includes a curved surface comprised of cross-sectional areas that are defined by one or more rounded side.

£87] Referring to Fig. 17, there are seen virtual representations of a bone anchor.

In one embodiment, the present invention comprise one or more module embodied as instructions stored on or in a computer readable medium in the form of software, hardware, or firmware and that are interpreted by a processor to enable creation, manipulation, and display of a 3D representation of a bone anchor 1710a on a user interface or display. In one embodiment, the one or more module is used to import or generate a first stereolithography (STL) file representative of the 3D representation 1710a. in one embodiment, one or more module is configured to allow a user to manipulate the shape and orientation of the 3D representation 1710a to fit against the surface of the 3d representation of a patient's maxil!a. In one embodiment, after manipulation, the processor is configured to save a manipulated version 1710b of the 3D representation 1710a as a second STL file, in one embodiment, a printer is configured to use the second STL file to create a physical copy of the manipulated version 1710b.

£883 Referring to Fig. 18, there is seen a representation of the location of a

zygomatic maxillary suture. As known to those skilled in the art, human skulls comprise a plurality of anatomic sections that are joine by sutures in Fig. 18, line "L" points to a typical location of a zygomatic maxillary suture that separate maxillary (left of the suture) and zygomatic (right of the suture) portions of a skull.

[89] Referring to Fig. 19, there is seen a representation of a human skull. In Fig.

19, dots with different shades indicate variability of the maxillary cortical bone thickness at a different locations on a skull, where the darkest dots indicate more thickness than lighter dots, where each dot is separated by about 5mm. In Fig. 19, a virtual representation of a bone anchor 1910 that has not been fully manipulated is overlay ed over the representation of the skull to illustrate how screw holes in its plate 1921 are desired to be configured to overlay thicker regions (darker dots) of the zygomatic buttress of the maxilla in Fig. 19, plate 1921 comprises a nghi/distai portion that is generally slanted with respect to a central axis defined by a top portion of connecting piece 1920 and so as to generally match the slope/slant of the

zygomaticomaxillary suture of the skull and so as to take advantage of the thick portions of the skull bone adjacent the suture. In one embodiment, the plate also comprises an !eft/medial portion that is generally in alignment with the axis, so that when coupled to the maxillary buttress, screws used to atach the bone anchor will be better positioned to avoid thinner portions of bone that is typically present in the anterior sinus region of the skull,

[SO] As discussed above, the present invention enables the shape of bone

anchors to be customized to the structure and shape of each patient's skull. To achieve such customization, in one embodiment, the present invention utilizes software analysis of patient specific 3D data derived from CBCT, CT, or !V!Rl scan. After processing patient image data, each patient's skull and bone thickness and geometry is derived from the data to create a model of the skull that can be displayed in 3D The 3D model and data can be used by a technician or clinician to design an optimized bone anchor by manipulating an initial virtual representation of a bone anchor created from a first STL file (see 1710a in Fig . 17} so that it fits to and along contours of the 3D model at locations that are optimized for mounting screws. During manipulation of data, geometrical changes to the bone anchor can be visualized in real-time, for example, a shape, length and/or thickness of a connecting piece can increased or decreased so that it property exits keratinized tissue, or at another desired location, where the plate is intended to be mounted, while at the same time taking into account a desired location for where a bottom first end of the bone anchor is desired to be positioned. Further, during manipulation, a second top end of the bone anchor may many be manipulated so that the surface of its plate conforms to the surface of the patient's skull at a desired point of attachment.

[91] in one embodiment, virtual manipulation of a bone anchor includes placement of it's second top end along the posterior/supertor portion of a patient's maxilla while positioning it's first bottom end roughly 2mm above their gum line, where in actual use, this location typically provides thicker bone structure for mounting of bone screws, and a mounting point that is close to the center of resistance of the maxilla and that is close to the zygomaticomaxillary suture in one embodiment, once the location of the suture has been established, a goal is to place a distal edge of the bone anchor plate along the suture line while having the neck drop between the first and second molar. It is identified, however, that for some patient’s having bone thickness determined to be different from the representative skull of Fig 19, optimal location of a first end and second end of a bone anchor may be different from that described above.

After manipulating a virtual bone anchor to obtain a desired fit to a particular patient’s geometry and/or to the thick portions of the maxilla, data representative of it manipulated shape is saved as a second STL file, which data can subsequently be used to manufacture a physical bone anchor. In one embodiment, bone anchors according to the present invention are manufactured via additive 3D printing by using data stored in the second STL file. In one embodiment, to facilitate easier

manipulation of a virtual representation of a to second end and connecting piece of a bone anchor, the first STL file comprises separate data representative of a virtual bone anchor that does not include a bottom first end, and separate data

representative of a virtual bottom first end. In one embodiment, after the virtual bone anchor sans a bottom first end is manipulated to fit a particular location on the skull (see 1710b in Fig. 17), the virtual representation of the bottom first end is displayed, and the bottom first end with a desired shape and in a desired orientation is virtually joined aligned to a bottom portion of the connecting piece. After joining and alignment, data representative of a complete bone anchor is saved in a second file, and the second file can be used to manufacture the bone anchor, for example, as represented by bone anchor 2010 in Fig. 20. In one embodiment, the second file comprise an STL file that is used to manufacture the bone anchor via 3D printing in metal as is known to those skilled in the art. In one embodiment, printing is performed using grade 5 titanium or other material having a similar hardness and/or stiffness. During virtual manipulation, in some embodiments, the relationship of the geometry of one part of a bone anchor may be manipulated relative to another part to achieve optimal strength for a particular amount of force desired to be applied to the bone anchor. For example, in one embodiment, the following equation may apply: (neck width) = (neck !ength)/T0, however. However, this relationship can vary based on different applications and different material uses, for example, stiffer

materials may require less thickness.

[93] Referring to Fig , 21 , there is seen a representation of the anatomy of a skull.

Although coupling of a bone anchor has been described as being preferably to certain regions of a patient’s maxilla along a maxillary butress (i.e.

zygomaticomaxillary buttress), it is understood that depending on a particular patient's skeletal geometry or a particular other application, bone anchors of the present invention can be configured to be coupled to fit against other portions of a patient's maxilla, including, but not limited to the nasomaxillary buttress or to the nasomaxillar buttress and the zygomaticomaxillary butress.

[94J Referring to Figs, 22a~b, there are seen embodiments of bone anchors that are customized to provide optimized anchorage given a patient’s specific geometry and anatomy, as well as desired end use/orthodontlc procedure. Referring back to Figs. 4a-c, there is seen a representation of a bone anchor which comprises a generally fiat plate at its top second end, a connecting piece with a middle portion that is generally straight and rounded in a cross-section, and a bottom first end that comprises a cylindrical connector having an aperture defined by an axis that is aligned generally parallel to plane in which the flat plane is disposed in Figs. 4a-c, the plate comprises two sides that generally symmetrical with respect to each other about an axis defined by the connecting piece, where each side of the plate comprises two apertures and where a center location of the apertures can be generally defined by corners of a square. As also described above, the shape and geometry of a bone anchor can differ from that represented by Figs. 4a-c, For example, as represented by Fig 20 a piate of a comprises a left and right portion, wherein the left and right portion each comprise at feast two apertures, wherein apertures in the right portion are disposed along an axis that is generally slanted with respect to an axis of the connecting piece at its connection to the pfate, and wherein the apertures in the left portion are disposed along an axis that is generally parallel with respect to the axis of the connecting piece. In the embodiment of Fig. 20, the center of the apertures can be defined by corners of a polygon that has two non- paralle! sides, where the center of each of the two of the apertures on either side of the connecting piece correspond to the ends of the non-paraiiei sides it is

understood that the geometry represented by Fig. 20, as wet! as other geometries within the scope of the invention, may be reversed for a bone anchor used on an opposite side of the skull, In the embodiment of Fig. 20, an orientation of an axis of a cylindrical connector at the first bottom end is disposed in an orientation that is generally orthogonal to a plane a plate at the second top end is generally disposed in. As represented in Figs. 22a-b, in embodiment, an orientation of an axis of a cylindrical connector at the first bottom end is disposed in an orientation that is generally parallel to a plane the plate at the second top, however in Fig. 22b, apertures in a plate at the top second end are disposed in other than at the corners of a square or polygon. In one embodiment, the plate is asymmetrically disposed about an axis defined by a top portion of a connecting piece in one embodiment, apertures in the plate at the top second end of a bone anchor are disposed generall in a linear relationship of three apertures. In one embodiment, apertures in the plate define an L-shaped relationship of 4 apertures. In other embodiments, depending on the amount of available intra-oral geometry or a desired amount of force needed to secure a bone anchor to a particular portion of the skull, a bone anchor can be manufactured to comprise more or fewer apertures in its plate. m Those skilled In the art will identify that many other embodiments are also within the scope of the present invention, which should be limited only by the extent of the present or future claims presented along with the present application

£963 Ail of the prior description and FIG. 1-22 may be found in international

application no. PCT/US2018/042200 titled SYSTEM, COMPONENTS AND

METHOD FOR TREATING MAXILLARY DEFICIENCIES AND CRANIOFACIAL DYSTROPHY, which published as WO 2019/018249 on January 24, 2019.

P?3 The bone anchor and facebow components described above may be

configured to achieve additional novel treatments of the maxillofacial complex.

Orthodontic devices may be designed to apply transverse forces to the maxilla to provide additional treatment modalities. For example, parallel expansion of the maxilla may be achieved using only intra-oral forces. In addition, modification of the extra-oral portion of a facebow allows for the application of unequal lateral forces to the maxilla to provide asymmetric maxillary protraction. mi One current method of treating maxillary deficiency requires use of a palatal maxillary skeletal expander. With children, palatal expanders have been used to expand the maxillary arch to create room for the growth of permanent teeth or to widen the upper jaw so that the bottom and upper teeth will better fit together better. In some cases, the jaw is expanded as a treatment to a compromised airway. Some known palatal expanders comprise and expand the maxillary arch by tooth (molar) borne anchorage means (bands) bridged together by an adjustable screw

mechanism (see U.S. Pat. no 5,564,920 to Klapper), As the screw is turned, a bilateral force is generated against the teeth and jaws to cause displacement of the teeth and the maxillary arch. Once installed, the adjustable screw Is rotated using a toot. The screw conventionally comprises two opposing halves, each half having a threaded portion. The force from the expanding scre is transferred through arms of the device to the banded molars and ultimately results in expansion of the maxillary dental arch and/or growth from the median palatine suture. The expande is left in for a therapeutically effective period and the patient, or patient’s caregiver, activates the expander by rotating the screw a predetermined amount over a predetermined period appropriate to the expander screw configuration, age of the patient, and condition for which treatment is applied (for example, a ¼ turn producing 0.25 mm of movement once per week, or a ¼-½ turn a day producing 0.25-0.50 mm of movement per day). Following a desired expansion, a holding phase is performed, leaving the expander in place for 3-6 months for stabilization, during which time the screw is locke in place to prevent the screw from backing up. During the holding phase the tootb/jaw interface stabilizes in a new position and the palatine suture grows back together across the space, after which time the expander is removed. The expander described above expands the space across the palatine suture via forces that are directly applie to only the teeth. m Another known transverse expander device is demonstrated in U.S. Pat. no.

9,351,810 to Moon. The Moon expander uses mini screws/temporary anchorage devices to mount a pair of bodies to the ceiling of the hard palate on either side of palatine suture. Each of the bodies in Moon also comprise a pair of extending arms and a pair of tooth anchorage bands devices similar to that used by Klapper as described above. The Moon expander comprises a double ended screw located between the pairof bodies. When the double ended screw in Moon is rotated, forces are applied directly not only to the teeth, but also by the mini screws to the hard palate on either side of the palatine suture. Unlike the Klapper device, since force is also applied directly to the hard palate, a reduced amount of force can be applied to the teeth, and a greater amount of force on the bone, which reduced force means stresses on the tooth/jaw interface can be reduced. However, the Moon expander also has a number of disadvantages. By applying forces directly to the hard paiate, the mini screws are put under stress and thus are subject to potential breakage, as is also the bone structure in the area where the screws are inserted. Further, although Moon applies less force to the teeth, St nevertheless transmits force to and causes movement of the teeth, which may not be desired. For example, when treating transverse maxiilary deficiency in skeietally mature individuals, transmitting force to the teeth can result in undesired alveolar effects, such as alveolar“bending,” toot root resorption, and potentially even a "scissors bite.” Furthermore, Moon's expander is only supported by two mini implants on each side of the median palatine suture, which often times in more skeietally mature individuals is insufficient and inefficient at generating the desired orthopedic effects, such that could occur with surgical osteotomy followed by expansion in cases of high difficulty, such as patients with very thin palatal bone or a very interlocked suture, the anchorage in the palate alone may not be sufficient to achieve desired skeletal growth results. In these cases of high difficulty, the ability to utilize anchorage on the zygomatic buttress rather than only the palatal process of the maxilla would be a powerful tool for clinicians treating maxillary deficiency.

Although expansion is traditionally achieved through devices anchored in the palate, it has been shown that achieving parallel expansion of the maxilla can be very challenging, especially in mature patients. Because the center of resistance of maxiilary expansion is located at a higher location than paiataliy anchored expansion devices, expansion of the maxillofacial complex tends to decrease in the upper locations on the maxilla. As a result, paiataliy anchored expansionary devices often result in a pyramidal type expansion, wherein the expansion of the maxillofacial

complex is greatest at the locations in the lower maxilla toward the teeth, and expansion is least in the upper maxilla regions like the orbital and zygomatic regions. This invention identifies that it is desirable to apply an expansionary force closer to the maxillary center of resistance than is possible with pa!ataiiy anchored appliances. In order to accomplish this, a lateral force can be applied intraora!ly to bone anchors coupled to regions in the upper maxilla. Since the zygomatic buttress is a primary resistor of maxillary expansion, it is envisioned that a lateral force applied to a bone anchor located on the buttress of the maxilla will result in not only more parallel expansion and less pyramidal expansion, but also result in greater ability to successfully expand difficult mature patients characterize by greater interlocked suture than adolescent patients. Additionally, being able to apply the expansionary force at an additional advantageous location like the maxillary buttress will present a new treatment option for patients with poor bone quality or quantity that make it difficult to expand exclusively from the palate. In short, the ability to achieve anchorage at an advantageous location of the maxillary butress an apply an expansionary force can be used as a tool to achieve higher quality expansion results, as well as treat more difficult cases wherein palatal anchorage expansion is not sufficient.

[101] The term "intra-oral” means within the mouth.

[102] The term“extra-ora!” means outside the mouth.

[103] The term“zygomatic buttress” refers to a portion of the zygomatic bone (also known as the cheekbone or malar bone). The term“zygomatic buttress” does not include the teeth or the palatine bone.

[104] Fig. 23 illustrates a perspective view of an orthodontic device that is capable of providing intra-ora! maxillary expansion. An intra-oral expansion device 2300 includes an attachment portion 2310 coupled to a previously attached bone anchor 2320 via a coupler 2330 A second attachment portion at the opposite end of the intra-oral expansion device is coupled to a second previously atached bone anchor (not shown). Alternatively, the attachment portion may be directly coupled to the bone anchor without the use of a coupler. The bone anchor may be a patient- specific designed and manufactured bone anchor. The bone anchor is preferably anchored to the zygomatic buttress of the maxilla. The intra-oral expansion device may optionally be coupled to additional bone anchors.

[105] The intra-oral expansion device is a simple spring that produces opposing expansive forces at the attachment portions, much like a bow. The intra-oral expansion device may optionally include one or more curved or wound spring portions, such as a torsion spring, to provide the expansive forces. The intra-oral expansion device may be composed of any biocompatible material that is capable of retaining its original shape after being deformed. Preferably, the intra-oral expansion device comprises spring metal, such as spring steel.

I106J The intra-oral expansion device Is removable to permit simple installation and removal by a user. The user may connect the intra-oral expansion device to the patient's maxilla by coupling the attachment portions of the intra-oral expansion device to the bone anchors or to the couplers, if present. The elastic behavior of the spring requires the user to compress the attachment portions of the intra-oral expansion device towards each other by applying compressive forces to the attachment portions during installation. Once the intra-oral expansion device has been installed and the compressive forces removed, the spring generates restorative opposing sprin forces that apply transverse forces to maxilla. The opposing transverse spring forces may be used to treat a transverse maxillary deficiency of the patient.

[107] The intra-ora! expansion device may be configured to deliver a specific

amount of restorative force necessary to achieve a desired amount of transverse displacement and growth of the maxillary buitress/mid-palata! suture of a patient.

The intra-ora! expansion device may generate a restorative spring force between 100-2000 gram-force {gf), including 150 gf, 200 gf, 250 gf, 300 gf, 350 gf, 400 gf, 450 gf, 500 gf, 550 gf, 600 gf, 650 gf, 700 gf, 750 gf, 800 gf, 900 gf, 1000 gf, 1100 gf,

1150 f, 1200 gf, 1250 gf, 1300 gf, 1350 gf, 1400 gf, 1450 gf, 1500 gf, 1550 gf, 1600 gf, 1650 gf, 1700 gf, 1750 gf, 1800 gf, 1900 gf and 1950 gf. The intra-oral expansion device may also generate a greater restorative spring force of between 0.1-52 kilogram-force (kgf). including 0.2 kgf, 0.3 kgf, 0.4 kgf, 0.5 kgf, 0.6 kgf, 0.7 kgf, 0.8 kgf, 0.9 kgf, 1 kgf, 2 kgf, 3 kgf, 4 kgf, 5 kgf, 6 kgf, 7 kgf, 8 kgf, 9 kgf, 10 kgf, 15 kgf, 20 kgf, 25 kgf, 30 kgf, 35 kgf, 40 kgf, 45 kgf and 50 kgf.

[108] The intra-oral expansion device is preferably dimensioned to fit entirely within a patient’s mouth. The specific size of the intra-oral expansion device will depend on the size of the patient's intra oral cavity and/or desired position of the bone anchors. The diameter of the intra-oral expansion device may be varied to provide a desired amount of spring force and wit! depend on the specific material used for the device, For example, the intra-oral expansion device may comprise spring metal and have a linear length of 12 cm and a diameter of 1.3 mm. A significant advantage of sizing the intra-oral expansion device to fit within the patient's mouth is that the device may be used u to 24 hours per day. In addition, a device that fits entirely within a patient’s mouth eliminates the need for extraoraf orthodontic or medical equipment.

[109] Fig 24 illustrates an orthodontic device that is capable of providing both

maxillary protraction and intra-oral maxillary expansion. The orthodontic device 2400 includes a first facebow 2410, for providing maxillary protraction, cou led to a second facebow 2420, for providing intra-oral maxillary expansion. The first facebow includes a first extra-oral attachment portion 2430 and a second intra-oral attachment portion 2440. The first extra-oral attachment portion and the second extra-oral attachment portion may each independently be coupled to an external anchorage or protraction device (not shown - see Fig, 3 or Fig 10). The second facebow includes a first intra-oral attachment portion 2450 and a second intra-oral attachment portion 2460, The first intra-orai attachment portion and the second intra-oral attachment portion may each independently be coupled to a previously- installed bone anchor coupled to a patient’s maxilla (not shown - see Fig. 23). The second facebow includes a first spring 2470 and a second spring 2480, The first spring and the second spring provide transversely opposed spring forces to achieve maxillary expansion, as described above. In an alternative configuration, the first facebow and the second facebow may be a single monolithic component

[110] The first facebow and the second facebow of the orthodontic device function synergisticaify to provide enhanced treatment of maxi ary deficiencies. It has been recognized that maxillary protraction results in a compressive force on the mid- palatal suture, which inherently promotes constriction of the maxillofacial complex Moreover, applying an expansionary force to the maxilla tends to loosen the maxillary sutures and facilitate protraction. Accordingly, the maxillary expansion provided by the second facebow both enhances the maxillary protraction provided by the first facebow while also preventing constriction of the maxillofacial complex. These features allow the orthodontic device to simuitaneous!y treat transverse maxillary deficiencies and forward longitudinal maxiilary deficiencies while avoiding future maxillofacial complications that may arise from the use of a protraction device alone.

[111] Fig. 25a illustrates an orthodontic device that is capable of providing maxillary protraction and treating transverse craniofacial asymmetry. Fig. 25b illustrates a perspective view of the orthodontic device shown in Fig. 25a. The orthodontic device 2500 includes a facebow 2510, for providing maxillary protraction, coupled to a lateral attachment portion 2520, for providing asymmetric lateral forces to the maxilla. The facebow includes a first extra-oral attachment portion 2530 and a second extra-oral attachment portion 2540. The first extra-oral attachment portion and the second extra-oral attachment portion may each independently be coupled to an external anchorage or protraction device. The facebow also includes a first intra- oral attachment portion 2550 and a second intra-oral attachment portion 2580. The first intra-oral attachment portion and the second intra-oral attachment portion may each independently be coupled to a previously-installed bone anchor coupled to a patient's maxilla. The lateral attachment portion extends from the middle of the facebow and may be coupled to an external anchorage or protraction device in an alternative configuration, the facebow and the lateral attachment portion may be a single monolithic component.

[112] Fig. 28a illustrates a perspective view of an orthodontic device that is capable of providing maxillary protraction and treating transverse craniofacial asymmetry in use. Fig. 26b and Fig, 26c illustrate a side view and top view, respectively, of the orthodontic device In use. The orthodontic device 2600 includes a facebow 2610 and a lateral attachment portion 2620 The facebow includes a first extra-orai attachment portion 2630 and a second extra-oral attachment portion 2640, and a first intra-ora! attachment portion 2650 and a second intra-oral attachment portion, opposite the first intra-oral attachment portion (not shown). The first extra-oral attachment portion and the second extra-ora! attachment portion are coupled to an external anchorage and protraction device 2660 by a first force applicator 2635 and a second force applicator 2645. The lateral attachment portion is coupled to the external anchorage and protraction device by a third force applicator 2625. The first intra-oral attachment portion is coupled to a first bone anchor 2670, The second intra-oral attachment portion is coupled to a second bone anchor, opposite the first bone anchor (not shown). The first bone anchor and the second bone anchor are preferably coupled to the zygomatic buttress of the maxilla. The first force

applicator, the second force applicator and the third force applicator work together to apply asymmetric maxil!ary protraction.

[113] The lateral attachment portion may have any configuration that allows it to transmit an external lateral force to the patient’s maxilla through the bone anchor. Examples of suitable configurations include a hook and a ring.

[114] The protraction and lateral forces may be provided by any suitable externa! anchorage or protraction device with one or more force applicators capable of consistently applying a desired force level to the orthodontic device. Examples of suitable force applicators include springs, elastics and wires. The force applicators may be chosen to provide a desired amount of force to various locations of the patient’s maxilla. The force applicators ma each independently provide the same amount of force, or may provide different amounts of force. For example, the first force applicator and the second force applicator may each be elastics that

independently apply 500 grams to the facebow, and the third force applicator may be an elastic that applies 200 grams to the lateral atachment portion. Only one side of the lateral attachment portion is coupled to the external anchorage or protraction device so that force is only applied to one side of the patient’s maxilla.

[115] Fig. 27 illustrates a force diagram showing the forces generate by the

orthodontic device including a facebow coupled to a lateral attachment portion as shown in Figs. 25a-h and Fig. 26a-c, Fig 27 represents a normal application of lateral spring forces by the facebow to two bone anchors, as well as application of an asymmetric lateral force to the attachment portion. For example, when 250 gram- force of lateral force is applied by the facebow to bone anchors, and when a lateral force is applied to the attachment portion in a right direction, more force is applied to the bone anchor at the right side of facebow (Re - 500 gf) than the bone anchor at the left side of the facebow (LE - 250 gf). Assuming protraction forces represented by PL and PR were to remain the same, application of a lateral force E to the attachment portion would cause moments to be generated and rotational forces to be applied to the facebow such that protracted movement and growth of patient’s maxilla could potentially occur in other than in a desired direction. As a result, it may be necessary to apply non-equal protraction forces Pi. and PR, For example, to offset rotational moments generated by a lateral force E of 250 gf an to maintain non rotated forward protraction of a maxilla, protraction force PR would need to be 750 gf and Pi would need to be 250 gf. Fig. 28 illustrates the calculations used to determine the forces shown in Fig. 27.

[116| The present invention is capable of not only treating craniofacial asymmetry in the transverse dimensions but also in the anterior posterior dimensions, in addition to applying an external expansionary force to the orthodontic appliance in order to treat transverse craniofacial asymmetry, non-equal or asymmetric protraction forces at PL and PR can be used to treat craniofacial asymmetry in the anterior posterior dimension as well. For example, in a patient wherein the right side of the maxilla, face or skull is narrower and more recessed than the left side, an additional lateral force E could be applied on the narrower right side and the protraction forces PR and PL can be modulated such that PR generates a greaterprotractionary force on the right side of the patient's maxilla, face or skull than the left side. Other combinations of anterior-posterior and/or transverse deficiency on the left or right sides of a patient's face can be treated by a corresponding modulation of the lateral force E and modulation of the protraction forces PR and PL to provide asymmetric

protraction.

[117] The orthodontic devices described herein may optionally be provided as a kit

A kit for treating a maxillary deficiency may contain one or more bone anchors, optionally one or more couplers, an orthodontic device and a plurality of force applicators. Preferably all components contained in the kit are sterile.

[118] Although the bone anchors are described above as being mounted to the zygomatic buttress of the maxilla, the bone anchors may be coupled to any bucca {cheek side) surface of the maxilla. The zygomatic buttress of the maxilla is the most preferred location for coupling the bone anchors.