The application is a divisional application of an application patent application with the name of improved maxillary arch expander and tractor device, application date of 2018, 11, 24 and application number of 202210655273.4.
The present application relates to and claims priority to U.S. provisional application Ser. No. 62/685,801 and acknowledgement No. 5437 filed by 6/15/2018, U.S. provisional application Ser. No. 62/590,363 and acknowledgement No. 3619 filed by 11/24/2017, U.S. provisional application Ser. No. 62/676,969 and acknowledgement No. 1055 filed by 5/26/2018, U.S. provisional application Ser. No. 62/699,264 and acknowledgement No. 7667 filed by 7/17/2018, U.S. provisional application Ser. No. 16/115,564 and acknowledgement No. 6177 filed by 8/29/2018, all of which are incorporated herein by reference for all purposes.
Disclosure of Invention
In one embodiment, the present invention relates to a medical device comprising at least two bodies, wherein each of the at least two bodies is configured to be coupled to a patient's maxilla and/or an at least partially out-of-the-mouth appliance, and wherein the at least two bodies are configured to apply force to the maxilla without coupling the device to the patient's teeth. In one embodiment, the invention still further comprises an adjustment mechanism configured to variably maintain the distance between the at least two bodies. In one embodiment, the invention includes a coupler configured to couple the ends of the appliance. In one embodiment, the invention includes the appliance. In one embodiment, the adjustment mechanism of the present invention includes threads. In one embodiment, the adjustment mechanism is configured to cause movement of the hard palate in a lateral direction with the at least two bodies coupled to the maxilla. In one embodiment, with the at least two bodies coupled to the maxilla, an external oral force applied to the orthodontic appliance causes movement of the maxilla forward or a combination of forward and upward. In one embodiment, with the at least two bodies coupled to the hard palate, extraoral traction applied to the appliance causes anterior or anterior and superior combined movement of the maxilla. In one embodiment, the direction of application of the external traction force is in line with the at least two bodies. In one embodiment, the at least two bodies are configured to be releasably coupled to the orthodontic appliance by fasteners. In one embodiment, the fastener is configured to form an interference fit, a snap fit, and/or a slip fit. In one embodiment, the appliance comprises an intraoral portion and an extraoral portion, wherein the intraoral portion and the extraoral portion are releasably coupled. In one embodiment, the at least two bodies coupled by the adjustment mechanism are configured to move the maxilla laterally. In one embodiment, the adjustment mechanism comprises a body having threads on only one end. In one embodiment, a first body of the at least two bodies comprises at least a first aperture and a second aperture, each aperture being arranged along a respective longitudinal axis, wherein the axis of the first aperture is not parallel to the axis of the second aperture. In one embodiment, each of the at least two bodies includes a plurality of threaded bores configured to receive threaded fasteners. In one embodiment, the device comprises threaded fasteners, wherein each of the threaded fasteners comprises two sets of threads, wherein one set of the two sets of threads is configured to mate with a corresponding threaded hole of one of the at least two bodies and the other set is configured to screw into the maxilla. In one embodiment, the maxilla is a hard palate. In one embodiment, each of the at least two bodies comprises a plurality of channels, each channel configured to receive a fastener along a longitudinal axis, wherein the longitudinal axis of at least one of the plurality of channels is non-parallel to the longitudinal axis of at least a second of the plurality of channels. In one embodiment, the longitudinal axis of the at least one channel is in an angular relationship with the longitudinal axis of the at least second channel, the angle being between 1-60 degrees.
In one embodiment, the invention includes a maxillary arch expander comprising a pair of bodies consisting of a first body and a second body, wherein each body of the pair of bodies is configured to be intraorally secured to a hard palate of a patient, and a fixation aligner, wherein the fixation aligner is configured to be secured to the pair of bodies to space the pair of bodies a predetermined distance. In one embodiment, the present invention includes a plurality of fasteners, a plurality of holes formed in the pair of bodies, a plurality of mating holes formed in the fixed aligner, the plurality of fasteners configured to fasten the fixed aligner to the pair of bodies by inserting the plurality of holes in the pair of bodies and the fixed aligner. In one embodiment, the present invention includes a plurality of holes including four holes formed in the fixed aligner and two holes formed in each of the pair of bodies. In one embodiment, the invention includes a plurality of holes formed in each of the pair of bodies, and a plurality of fasteners configured to fasten each of the pair of bodies to the hard palate by inserting the plurality of fasteners into the plurality of holes. In one embodiment, the plurality of holes in each of the pair of bodies includes at least three holes. In one embodiment, the fixed aligner includes two ends, and wherein each of the pair of bodies is configured to couple one of the two ends, respectively. In one embodiment, the fixed aligner comprises a wire. In one embodiment, the fixed aligner comprises a single material. In one embodiment, the expander is configured to be secured to the hard palate, with a space between the pair of bodies and hard palate surface tissue.
In one embodiment, the present invention includes a maxillary arch expander comprising a first pair of bodies, wherein each body is configured to couple to a patient's maxilla, and an adjustable aligner, wherein the adjustable aligner is configured to be releasably secured to the first pair of bodies to change a first distance between the first pair of bodies by applying an expanding force to the first pair of bodies. In one embodiment, the adjustable aligner includes a second pair of bodies and an expansion screw disposed between the second pair of bodies. In one embodiment, the invention includes a pair of implements and at least two supports, wherein each support includes a first end and a second end, wherein the first ends of the at least two supports are respectively coupled to and extend from a respective one of the first pair of bodies, and wherein the second ends of the at least two supports are respectively coupled to the implements. In one embodiment, the adjustable aligner includes a pair of implements, each implement coupled to a respective one of the second pair of bodies, wherein each of the implements is configured to match a shape of a palate. In one embodiment, the appliance is constructed of silicone or acrylic. In one embodiment, the appliance is configured not to couple with any teeth of the patient. In one embodiment, each of the first pair of bodies includes three holes configured to receive fasteners. In one embodiment, the three holes are threaded. In one embodiment, each of the second pair of bodies is configured to be coupled to a respective one of the pair of first bodies by at least two screws.
In one embodiment, the invention includes a method of applying an orthodontic force to a patient's maxilla without involving the patient's teeth, the method comprising the steps of providing at least two bodies, coupling the at least two bodies to a location of the maxilla, coupling an adjustable expander to the at least two bodies, applying an orthodontic force to the at least two bodies using the adjustable expander to cause movement of the at least two bodies relative to one another and cause expansion of the maxilla. In one embodiment, the adjustable expander includes threads at opposite ends of the expander. In one embodiment, the movement of the at least two bodies serves to expand the maxilla to both sides. In one embodiment, the adjustable expander has threads only at one end of the expander. In one embodiment, the movement of the at least two bodies is used to expand the maxilla unilaterally. In one embodiment, the location is on both sides of the palate midseam.
In one embodiment, the present invention includes a maxillary arch expander comprising at least one pair of bodies consisting of a first body and a second body, wherein each body of the pair of bodies is configured to be intraorally coupled to a patient's maxilla, and an aligner coupled to the pair of bodies and configured to space the pair of bodies a distance to cause expansion of the maxilla without the aligner or the at least one pair of bodies involving any teeth of the patient. In one embodiment, the aligner includes a fixed aligner or an adjustable aligner. In one embodiment, the at least one pair of bodies is selected from the group consisting of two appliances, two wires, and two fasteners. In one embodiment, each body of the pair of bodies is configured to be coupled to a maxilla within the oral cavity by at least one fastener. In one embodiment, each fastener includes two portions. In one embodiment, the two portions include threaded portions and the two threaded portions are separated by a non-threaded portion. In one embodiment, the two portions are separable. In one embodiment, each of the at least one pair of bodies includes a bore configured to receive a fastener, the fastener body having threads at both a top end and a bottom end, wherein the counterbore includes threads configured to threadedly mate with the fastener body top end. In one embodiment, the hole is a counter-sunk hole. In one embodiment, the top and bottom threads are separated by an unthreaded portion.
In one embodiment, the invention is directed to a method of treating a deficiency in maxillary development comprising the steps of providing a pair of first bodies, coupling the pair of first bodies to a hard palate of a patient, connecting an externally worn appliance to the pair of first bodies, and applying traction to the appliance to cause forward movement of the pair of first bodies. In one embodiment, the method provides an expander between the pair of first bodies, and moves the expander to cause lateral movement of the pair of bodies relative to each other. In one embodiment, the traction forces are aligned to cause only forward or forward and upward movement of the patient's maxilla. In one embodiment, the traction force produces little or no torque on the pair of bodies. In one embodiment, the direction of application of the traction force passes through the pair of bodies and past the point of application of the traction force on the implement.
In one embodiment, the present invention is directed to a method of laterally expanding a patient's maxilla comprising the steps of coupling a pair of first bodies to the maxilla while maintaining a first space therebetween in the oral cavity, coupling an adjustable aligner to the pair of first bodies, adjusting the adjustable aligner so that an expanding force is applied to the pair of first bodies to change the first space to a second space, removing the adjustable aligner from the pair of first bodies, and securing a first fixed aligner to the pair of first bodies to maintain the second space therebetween. In one embodiment, the step of creating a first space between the bodies includes securing a second first fixed aligner to the pair of first bodies to create the first space, and then removing the first fixed aligner from the pair of first bodies prior to installing the adjustable aligner. In one embodiment, the method includes the step of securing the appliance to each body. In one embodiment, the method includes the step of coupling the appliance to the hard palate of the patient instead of to the teeth. In one embodiment, each of the pair of first bodies is coupled to the hard palate on either side of the upper jaw central slit. In one embodiment, the method, the step of intraoral attachment of the bodies includes the step of inserting at least three fasteners through each body and into the hard palate.
In one embodiment, the invention is directed to a method of expanding a jaw center seam comprising the steps of providing a pair of first bodies, providing a pair of acrylic instruments, coupling the pair of first bodies and the pair of acrylic instruments to the hard palate in the oral cavity while maintaining a first distance between the pair of first bodies, and applying an expansion force to the first bodies such that the first distance between the first bodies becomes a second distance.
In one embodiment, the invention is directed to a method of augmenting a maxilla comprising the steps of providing a pair of first bodies, coupling the pair of first bodies to a hard palate, attaching an aligner to the pair of first bodies, and maintaining the pair of first bodies below and a distance from the maxilla. In one embodiment, the aligner is an adjustable aligner. In one embodiment, the aligner is a first fixed aligner. In one embodiment, the distance is between 0.1-0.3 mm. In one embodiment, the method includes providing a spacer between the pair of first bodies and the hard palate. In one embodiment, coupling includes the use of threaded fasteners. In one embodiment, the distance is maintained by locking the threads of the threaded fastener into the pair of first bodies.
In one embodiment, the invention includes a maxillary expander comprising at least two bodies, wherein each of the at least two bodies is configured to couple to a hard palate maintaining a first distance between the at least two bodies and the upper jaw, and an expander configured to maintain a second distance between the at least two bodies. In one embodiment, the expander includes a threaded end. In one embodiment, the expander is threaded at only one end. In one embodiment, the expander further comprises an aligner. In one embodiment, the aligner includes at least one body configured to be coupled to the at least two bodies. In one embodiment, the aligner comprises a fixed aligner. In one embodiment, the aligner includes an adjustable aligner. In one embodiment, the aligner includes an expander. In one embodiment, the at least two bodies are configured to receive fasteners. In one embodiment, the fastener is configured to be received by at least one lateral support extending from each of the at least two bodies. In one embodiment, the fastener comprises a screw. In one embodiment, the fastener includes two threaded portions, wherein an outer diameter of one of the two threaded portions is smaller than an outer diameter of the other. In one embodiment, the two threaded portions are separated by a non-threaded portion. In one embodiment, the at least two bodies are arranged parallel to each other.
In one embodiment, the invention includes a method of laterally expanding a maxilla comprising the steps of providing at least two bodies, coupling the at least two bodies to a hard palate, and attaching at least one aligner to the at least two bodies. In one embodiment, the at least one aligner includes a fixed aligner and/or an adjustable aligner. In one embodiment, the at least one aligner includes an attached fixed aligner and an adjustable aligner. In one embodiment, the at least two bodies comprise fasteners. In one embodiment, the fastener comprises a threaded fastener.
In one embodiment, the invention includes a medical device comprising at least two bodies configured to be coupled to a patient's maxilla, wherein each of the at least two bodies is configured to be coupled to an at least partially extraoral appliance, wherein the appliance is configured to apply traction to the at least two bodies, wherein the two bodies are configured to transfer an external oral force to the maxilla to cause movement and growth of the maxilla. In one embodiment, the at least two bodies further comprise a coupler configured to couple the orthodontic appliance ends. In one embodiment, the device comprises the appliance. In one embodiment, the appliance comprises an orthodontic facebow. In one embodiment, the adjustment mechanism, wherein in case the at least two bodies are coupled to the maxilla, is configured to transfer a force to the at least two bodies to cause the at least two bodies to apply a force to the maxilla to cause a lateral movement of the maxilla. In one embodiment, with the at least two bodies coupled to the maxilla, an external force applied to the at least two bodies by the appliance causes forward movement or a combined forward and upward movement of the maxilla. In one embodiment, the direction of application of force by the external traction force to the implement is in line with the at least two bodies. In one embodiment, the at least two bodies are configured to be releasably coupled to the orthodontic appliance. In one embodiment, the releasable coupling comprises an interference fit, a snap fit, and/or a slip fit. In one embodiment, the appliance comprises an intraoral portion and an extraoral portion, wherein the intraoral portion and the extraoral portion are releasably coupled. In one embodiment, a first of the at least two bodies comprises at least a first aperture and a second aperture, each aperture being arranged along a respective longitudinal axis, wherein the axis of the first aperture is not parallel to the axis of the second aperture. In one embodiment, each of the at least two bodies includes a plurality of threaded bores configured to receive threaded fasteners. In one embodiment, the device comprises a threaded fastener, wherein each of the threaded fasteners comprises two sets of threads, wherein one of the two sets of threads is configured to mate with a corresponding threaded hole of one of the at least two bodies, wherein the other of the two sets of threads is configured to be threadably threaded into the maxilla. In one embodiment, each of the at least two bodies includes a plurality of channels, each channel configured to receive a fastener along a longitudinal axis, wherein the longitudinal axis of at least one of the plurality of channels is non-parallel to the longitudinal axis of at least a second of the plurality of channels. In one embodiment, the longitudinal axis of the at least one channel is in an angular relationship with the longitudinal axis of the at least second channel, the angle being between 1-60 degrees.
The foregoing should not limit the invention as other advantages, benefits and embodiments are also within the scope of the invention, as described in the detailed description below.
Detailed Description
The drawings to which reference is made below depict the constituent components and features of the present invention. Although the same constituent elements may be shown in different figures, it should be noted that icons using the same constituent elements are not accumulated when the icons are redundant and/or may make the constituent elements more difficult to identify.
Figures 1a-c are schematic illustrations of the components of a bone fixation device to be fitted intraorally to both sides of a patient's palate midseam.
In one embodiment, the bone fixation device of the present invention includes a pair of first bodies 100a-b (only one body is shown in FIG. 1 a) configured to be attached to the maxilla along both sides of the intraoral maxillary central slit. In one embodiment, each body includes a side configured to face the hard palate and an opposite top side. In one embodiment, one or both sides are flat. In other embodiments, the two faces are parallel to each other. In one embodiment, at least a portion of one face is not parallel to the other face. In one embodiment, each first body 100a-b includes a plurality of first apertures 101 and a plurality of second apertures 102 disposed along a longitudinal axis of each first body. In one embodiment, each first body includes three first apertures 101 and two second apertures 102. In one embodiment, the first aperture 101 passes through the thickness of the first body 100 a-b. In one embodiment, the second aperture 102 passes only a distance through the first body 100a-b, and not through. In one embodiment, the bone fixation expander device further comprises a first fixation aligner 106, the first fixation aligner 106 having a plurality of third holes 199 configured to receive the first threaded fasteners 110. In one embodiment, the first fastener 110 is comprised of a screw configured to be received by the third aperture 199 and threaded into the second aperture 102. In one embodiment, the first fixed aligner 106 has the same number of third apertures 199 on a first side laterally to the left and on a second side opposite to the right. In one embodiment, the fixed aligner 106 includes four third apertures 199. In one embodiment, the fixed aligner 106 comprises a single unitary body. In one embodiment, the first fixed aligner 106 comprises a plate-like structure. In one embodiment, the first fixed aligner 106 comprises an H-shaped geometry. In other embodiments, the first fixed aligner includes a geometry that can have holes formed at four corners. In one embodiment, the third apertures 199 of the first fixed aligner 106 are configured to have a longitudinal spacing "B" that enables them to be coupled together with the corresponding second apertures 102 on the first bodies 100a-B by insertion of the first fasteners 110 therein. In one embodiment, when the pair of first bodies 100a-b are connected to the first fixed aligner 106 by fasteners, the lateral spacing of the third apertures 199 results in the pair of first bodies 100a-b being separated by a distance "Z". In one embodiment, the first bore 101 includes a channel that is countersunk into the first body 100a-b to a first depth that is less than the thickness of the first body such that the channel is threaded along the first depth and is configured to receive the threaded upper end of the second fastener 111 (fig. 2a-2 b) when inserted at the bottom of the rotating second fastener. In one embodiment, the first fixed aligner 106 and each of the first bodies 100a-b are sized to have the dimensions shown in FIGS. 1a and 1 b.
In one embodiment of use (see FIG. 1 c), the side of the first fixed aligner 106 facing the hard palate is placed over the respective bodies 100a-b, the respective first fasteners 110 are inserted into the third apertures 199 of the first fixed aligner 106, and the respective fasteners 110 are threaded into the second apertures 102 to couple the first fixed aligner 106 to the pair of first bodies 100a-b. After the first fixed aligner 106 and the pair of first bodies 100a-b are coupled, the combination is placed on the hard palate of the patient such that one of the first bodies 100a-b is on one side of the patient's jaw center slit and the other of the first bodies 100a-b is on the other side of the jaw center slit.
Figs. 2a-b are schematic illustrations of the components of the bony stationary arch expander device during its attachment to the sides of the hard palate midseam.
In one embodiment of use, after the first fixed aligner 106 and the pair of first bodies 100a-b are combined, they are fixed on both sides of the central slit on the hard palate and the combination is mounted to the hard palate with a plurality of threaded second fasteners 111. In one embodiment, each first body includes a plurality of threaded first holes 101, the first holes 101 connecting one side of the pair of first bodies facing the hard palate and the opposite side. In one embodiment, each of the pair of first bodies 100a-b includes three threaded first bores 101. In one embodiment, the screwable second fastener 111 includes a bottom portion configured to be screwed into the hard palate with a first set of threads and a top portion configured to be screwed into the first aperture 101 with a second set of threads. In one embodiment, the first set of threads and the second set of threads are separated by an unthreaded portion. In one embodiment, the outer diameter of the first set of threads is smaller than the outer diameter of the second set of threads. In one embodiment, the second fastener 111 is sized as given in fig. 2 b. In one embodiment of use, the bottom of the second fastener 111 is inserted through the corresponding first aperture 101 in the pair of first bodies 100a-b, and after insertion, the bottom of the second fastener 111 is threaded into the hard palate. Upon insertion of the bottom of the second fastener into the hard palate, the top of the second fastener 111 is threaded into the corresponding threads of the first aperture 101 in the pair of first bodies 100a-b until a surface portion of the top of the second fastener abuts a surface portion of the first aperture 111. In one embodiment, a torque between 0.1nm and 0.6nm is applied to the second fastener to insert them into the two cortical bones of the maxillary jaw and achieve fixation against and within the first body. In one embodiment, when the second fastener 111 abuts and is within the first body 100a-b, a fixed rigid structure is formed that is made more rigid by inserting the second fastener into the hard palate.
In one embodiment, one or more spacers 50 are inserted between the hard palate and the side of the pair of first bodies 100a-b facing the hard palate prior to inserting the bottom of the second fastener 111 into the hard palate. One or more spacers are used to determine a distance between the pair of first bodies 100a-b and the hard palate coated tissue. In one embodiment, the distance is 0.1mm-0.3mm. In one embodiment of use, the second fastener 111 is threaded into the hard palate until the pair of first bodies 100a-b lightly abut the one or more spacers 50 and the one or more spacers lightly abut hard palate tissue. In one embodiment, the spacer 50 is made of soft silicon. In another embodiment, the spacer 50 is made of a material that is dissolvable by the fluid in the oral cavity. In one embodiment, the spacer 50 is made of a material of the composition gluten-free wheat, yeast, salt and water that is baked into flakes that dissolve very rapidly when in contact with oral endocrine. In other embodiments, the spacer is made of resin or polycarbonate. After inserting one or more spacers 50 and mounting a pair of first bodies 100a-b onto the hard palate, in one embodiment, the spacers are removed or dissolved in situ, thereby creating an open space/gap between the first bodies and the hard palate. In one embodiment, the space/gap allows no or minimal contact between the first body 100a-b and the hard palate, which reduces the likelihood of tissue necrosis. In this manner, since the first body 100a-b is reduced from touching the hard palate, damage and irritation (necrosis) to the soft tissue of the upper jaw is also reduced, and the force acting on the upper jaw bone is maximized. The invention is not limited to forming the space/gap by using the described spacers, as other methods may also be used, for example by temporarily securing a pair of first bodies to the teeth with a surgical guide, thereby creating the space/gap during insertion of the second fastener 111, after which the temporary securing means may be removed. Furthermore, while the screwing of the top of the second fastener into the pair of first bodies to rigidly couple and secure the second fastener 111 to the bodies to a position below the palate is described herein, the present invention is not limited to the use of threads to accomplish this, as in other embodiments biocompatible resins or adhesives may be used in addition to or in lieu of the second set of threads described above, or clips, locks, interference fit coupling mechanisms may be used to couple the second fastener 111 to the pair of first bodies.
Fig. 3 is a schematic illustration of the constituent components of the bone anchor expander device with a pair of first bodies coupled to the patient's palate and with the first anchor aligner removed. In one embodiment of use, after the second fastener 111 is coupled to the hard palate of the patient, the first fastener 110 is unthreaded from the first body 100a-b and the first fixed aligner 106 is separated and removed from the pair of first bodies 100 a-b. After removal, the pair of first bodies 100a-B will be separated by a distance "D" determined by the distance "B" of the first fixed aligner 106 (see FIG. 1B).
Fig. 4a-j are schematic illustrations of the components of a bone-like fixed expander device comprised of an adjustable aligner and/or a pair of first bodies configured to promote movement and growth of the maxillary structure of a patient. In one embodiment, the bone anchor expander device of the present invention includes an adjustable aligner 150 (see FIG. 4 a). In one embodiment, the adjustable aligner 150 includes a pair of second bodies 151a-b, where each body is coupled by at least one adjustment mechanism formed therebetween. In one embodiment, each of the second bodies 151a-b is elongated along an axis. In one embodiment, when coupled by adjustment mechanism 152, each axis is generally parallel to the other axis. In one embodiment, the adjustment mechanism 152 comprises a two-start expansion screw threaded at both ends. In one embodiment, the adjustment mechanism 152 is configured to rotate about the pair of second bodies 151a-b such that each second body approaches or moves away from each other by the end of the adjustment mechanism being threaded with the threaded bore in each second body. In one embodiment, each pair of second bodies 151a-b is configured with an aperture sized to slidably receive an end of one or more stabilizing bars 175 inserted or threaded therethrough. In one embodiment, each of the second bodies 151a-b includes a plurality of threaded fourth apertures 198 configured through the bottom surface of the second bodies 151a-b opposite the hard palate and the top surface thereof. In one embodiment, the fourth apertures 198 are longitudinally spaced apart to match the longitudinally spacing of the second apertures 102 of each of the pair of first bodies. In one embodiment of use, the adjustment mechanism 152 is rotated to a position that enables the threaded first fastener 110 to be aligned and easily inserted through a corresponding fourth aperture 198 of the adjustable aligner 150 into a corresponding aperture 102 in each of the bodies 100 a-b. After being coupled in this manner, the pair of second bodies 151a-b will be spaced apart from each other the same initial distance "D" as the first bodies 101 a-b. After coupling, the adjustment mechanism 152 may be used to increase or decrease the lateral distance between the two pairs of second bodies 151a-b, the two pairs of first bodies 100a-b, and the first fastener 110, the change in distance being useful for treating patients with underdeveloped maxilla by bi-directionally expanding the maxilla structure and the 9 bones connected to the maxilla. In one embodiment, the adjustment mechanism 152 is not comprised of a bi-directional expansion screw with threads on both ends as described above, but instead is a single-sided expansion screw with threads on one end and no threads on the other end (see FIG. 4 d). In one embodiment, the unthreaded end is inserted through and freely rotatable in a bore of one of the second bodies 151a-b, while the threaded end is threadably coupled to a threaded bore in the other second body. The unthreaded end is secured by a retainer, such as a circular ring, to limit longitudinal movement within the bore relative to the second body. When the adjustment mechanism 152 rotates, one of the second bodies 151a-b remains stationary and the other moves. In one embodiment of use, it has been determined that a bone fixation expander device comprising a unilateral expansion screw as described above may be used to treat maxillary asymmetry. Although an increase in the distance between the two second bodies 151a-b is described above as being achieved in a rotational manner, it is contemplated that other mechanisms capable of causing movement of the second bodies 151a-b are within the scope of the present invention, such as springs, micro-motors, or some other passive or active actuator that may be used to achieve linear movement between the second bodies. In one embodiment, six fasteners are required for coupling the two first bodies 100a-b to the hard palate, three for each first body 100 a-b. The use of three second fasteners in each first body reduces the forces experienced by the fasteners as the first bodies move and also reduces the forces experienced by the local bones supporting the fasteners, as compared to the use of two second fasteners for each first body 100 a-b. With more of the second fasteners 111, the resistance to movement of the upper jaw against the second body 151a-b is applied to the fasteners and spread apart, reducing the force experienced by either fastener. Thus, in other embodiments, it is within the scope of the present invention to use more than three second fasteners 111 and more than three holes in the first body for receiving the fasteners in order to reduce the forces to which the fasteners and/or the local bones supporting the fasteners are subjected, as needed or desired.
Referring to fig. 4e, although some of the embodiments described above use a fixed aligner 106 to provide initial alignment with the pair of first bodies, in one embodiment such alignment may be provided without the use of an aligner 106. In one embodiment, the first threaded fastener 110 is inserted through the respective fourth apertures 198 of the pair of second bodies 151a-b and then threaded into the respective second apertures 102 of the pair of first bodies 101 a-b. After being coupled in this manner, a pair of first bodies 100a-b will be spaced apart an initial distance that is determined by how many revolutions the expansion mechanism 152 or 162 has rotated. Subsequently, the pair of first bodies 100a-b may be coupled to the upper jaw at the initial spacing by first inserting four second fasteners 111 into the first holes 101 at both ends of the pair of first bodies 100 a-b. After coupling to the palate, the pair of second bodies 151a-b can be removed and the coupling of the pair of first bodies to the hard palate can be reinforced by inserting two additional second fasteners 111 into the first holes 101 intermediate the pair of first bodies 100a-b, as desired. After the first bodies 100a-b are coupled to the upper jaw by the complete complementation of the second fasteners 111, the pair of second bodies 151a-b may be re-coupled to the pair of first bodies 100a-b for later use by inserting the threaded first fasteners 110 into the fourth apertures 198 and then further into the corresponding second apertures 102 of the pair of first bodies 100 a-b.
It has been found that such an arrangement maximizes the force transferred to the tissue of the midgap against movement when it is desired to minimize the initial distance between the second bodies 151a-b (see the adjustable aligner 150 in fig. 4f, without the stabilizing bars 175), such as when the first bodies 100a-b or the second bodies 151a-b are initially desired to be mounted as close as possible to the jaw midgap. As shown in fig. 4g, while in one embodiment the adjustment mechanism 152 between the second bodies 151a-b enables a minimum distance of up to 2.5mm between the second bodies, it also determines the maximum distance of 10mm and also determines how much the outer end of the adjustment mechanism 152 will protrude outwardly from the second bodies at the minimum distance shown in fig. 4 f. It has been determined that in some cases, the outer end of the adjustment mechanism may interfere with the anatomy of the patient's tongue or mouth when it is extended too far. In addition, when an expanding force is applied to the second bodies 151a-b, in the palate where the space is small, the bodies may start to enter into the tissue of the wall of the palate due to insufficient space in the lateral direction.
Fig. 4h illustrates that in order to minimize or eliminate interference with the patient's oral anatomy, in some embodiments, the adjustable aligner 150 includes an adjustment mechanism 172. In one embodiment, the adjustment mechanism 172 comprises a telescoping, expanding screw mechanism. In one embodiment, the expansion screw mechanism includes a housing 172a having two threaded bores at opposite ends, and two threaded rods 172b each having a first threaded end threadably threaded into the corresponding threaded bore and a second threaded end threaded into the corresponding threaded bore of the second body.
In one embodiment of use, rather than using only one of the adjustment mechanisms 152 or 172 to achieve the desired expansion of the patient's maxilla/palate, it is desirable to use both simultaneously. For example, where it is desired to initially place a first or second body over the palate midsuture in close proximity, and where it is desired to have subsequent expansion greater than the adjustment mechanism 152 is capable of providing an expansion distance, an adjustable aligner 150 comprising the adjustment mechanism 152 may be used to achieve a first distance (e.g., a distance of 10 mm) between the second bodies, after which the first distance is achieved, the adjustable aligner may be removed and replaced with an adjustable aligner 150 comprising the adjustment mechanism 172 to achieve a second distance (15 mm) between the second bodies. The initial and final distances described above with respect to using adjustment mechanisms 152 and 172 are intended to be examples, as in other embodiments adjustment mechanisms 152 and 172 may be configured to enable smaller or larger distances, for example, by appropriately selecting their lengths and/or modifying the subject.
Fig. 5a-b are schematic illustrations of the structural components of a bone-based fixed arching expander device, including a pair of first bodies and a pair of instruments prior to coupling with the pair of first bodies. In some cases, the combination of the adjustable aligner 150, the first bodies 100a-b, and the fasteners 111 may not be sufficient to achieve the clinically desirable maxillary expansion due to the bone anatomy being too thin or too thick. Thus, to further reduce the stresses placed on the bone by the threaded fasteners, in one embodiment, the bone anchor expander device of the present invention includes a pair of instruments 120a-b. In one embodiment, each implement includes at least one extension support 125 (see fig. 5 b). In one embodiment of use, the first end 130 of each support 125 is configured to be coupled to the respective second aperture 102 of the pair of first bodies 100a-b, and the opposite second end 131 of the support is embedded in the respective plate 132. In one embodiment, each plate comprises acrylic or other sufficiently rigid biocompatible material as known to those skilled in the art of dental equipment. In one embodiment, the first end 130 of each extension support 125 is spaced the same distance "Y" as the second aperture 102 in each first body 100a-b when embedded within the plate 132. In one embodiment, each first end 130 includes an aperture configured to receive a respective fastener 110. In one embodiment, the plates 132 are made and sized according to a die or digital scan of the oral cavity so that when used in the oral cavity they rest comfortably against the palate tissue without directly touching any teeth.
Fig. 6a-d are schematic illustrations of the constituent components of a bone-type fixed arching expander device including a pair of first bodies and a pair of appliances coupled to the pair of first bodies before and after the adjustable aligner couples the pair of first bodies. In one embodiment of use, the threaded first fastener 110 is inserted through a corresponding hole in the first end 130 of the extension support 125 of the appliance 120a-b (see fig. 6 a-b), a corresponding fourth hole 198 of the adjustable aligner 150, and threaded into a corresponding second hole 102 of the pair of first bodies 100a-b, thereby integrating the three components, which when coupled to the upper jaw and expanded by the adjustment screw 152, can apply additional corrective forces to both sides of the upper jaw center seam. In one embodiment (see fig. 6 c), rather than initially providing the appliances 120a-b as separate units from the adjustable aligner 150, each appliance is provided as part of a respective second body 151a-b, such that the adjustable aligner 150 and each appliance can be attached to the pair of first bodies 100a-b as a single unit. Fig. 6d shows an integral body in which a first end of one set of supports 125 is integrated into the second body and the opposite other set of ends can be moulded onto it by a plate (not shown).
Figures 7a-b are schematic illustrations of the components of a bone anchor expander device including an instrument for increasing the distance between adjustable aligners with an adjustment mechanism. In one embodiment of use, the adjustable aligner 150 is coupled to a pair of first bodies 100a-b and the distance between the pair of second bodies 151a-b is increased by rotating the adjustment mechanism 152, which increase in distance results in an increase in the distance between the pair of first bodies 100a-b and the instrument 120 a-b. In an embodiment, this increase in distance is achieved through the use of a wrench, activation key, or other device configured to move or rotate adjustment mechanism 152/162. In one embodiment, gradually increasing the distance between the second bodies 151a-b causes lateral expansion of the patient's maxilla, wherein the increment determines the amount of expansion that is potentially achievable. In using the adjustable aligner 150, it was determined that the portion of the second fastener 111 at the location where it was inserted into the hard palate was exposed due to the small space/gap created between the hard palate and the pair of first bodies (see discussion above of using the spacer 50 to create space/gap in fig. 2). The presence of the space results in an increase in the stress to which the second fastener is subjected at the location of insertion into the hard palate as compared to the absence of the small space by the resistance to movement of the palate midseam coupled at one end of the second fastener and the movement imparted by the second body 151a-b coupled at the other end of the second fastener as previously described. The force applied to the fastener 111 means that the stress is also experienced at each insertion point in the hard palate. It was thus determined that it was desirable to reduce the localized stresses applied to the fastener 111 and the maxilla. One method of reducing fastener stress includes distributing stress over more fasteners as described above. However, when the appliances 120a-b are also used, as their plates 132 bear against the palate, expansion of the second bodies 151a-b will cause the plates to exert a force against the soft palate and thus the hard palate that can be used, at least in part, to overcome the resistance to expansion of the upper jaw, which in turn can be used to further reduce the stress to which the fastener is subjected. The three methods of screwing the tips of the second fasteners 111 into the corresponding threaded holes of the pair of first bodies 100a-b, using more than two second fasteners 111 per first body, and using the appliance described above, can be used alone or in combination to secure the pair of first bodies 100a-b and second bodies 151a-b, thereby eliminating the need for a molar or tooth-loaded fixture. By eliminating the force transfer to the teeth, a number of benefits are obtained, namely a better orthopedic effect with respect to the effects of the alveoli or teeth. Better orthopedic effects are associated with larger airways and aesthetic benefits. Moreover, since the teeth are not involved and are not in contact with the teeth, many risks are eliminated, including root absorption, tooth tipping and possible scissor-like occlusion. While it is preferable not to involve and not touch the teeth, it is to be understood that the embodiments of the present invention described further above or below do not interfere with coupling with the teeth when a particular clinical result is desired or needed.
Fig. 8 is a schematic view of a pair of first bodies after removal of the adjustable aligners and tools after increasing the distance between the adjustable aligners by a clinically desired amount. In one embodiment of use, after the distance between the pair of first bodies 100a-b has been increased to a clinically desirable distance "D2", the first fastener 110 is unscrewed and the adjustable aligner 150 is removed, if an instrument 120a-b is used, as well. In one embodiment, to regrow the maxilla center while maintaining distance "D2", a pair of third bodies 170a-b are secured over the pair of first bodies 100 a-b. In one embodiment, each third body 170a-b includes a plurality of fifth apertures 195, each fifth aperture 195 being longitudinally spaced apart at the same spacing as the second apertures 102 of each first body. In one embodiment, the aperture 195 connects the face of the pair of third bodies 170a-b that is opposite the upper jaw and the top face and is configured to receive the fifth fastener 191 therethrough.
Fig. 9 is a schematic view of a pair of first bodies and a pair of third bodies coupled by inserting respective fifth fasteners 191 into respective fifth holes 195 and threading the respective fifth fasteners into respective second holes 102 of the pair of first bodies 100 a-b.
Fig. 10a-d are schematic illustrations of the components of a bone anchor expander device including a second anchor aligner. In one embodiment used, a second fixed aligner 196 is used in order to maintain the distance "D2" when the first and third bodies 100a-b and 170a-b are coupled. In one embodiment, the second fixed aligner 196 includes a body configured to have a shape that maintains the distance "D2" during the holding/stabilization phase, i.e., the phase in which the patient's palate middlegap regrows with bone and maintains the distance "D" by itself without use of embodiments of the present invention. In one embodiment, the second fixed aligner 196 comprises a wire bent to have its ends 166 and 167 inserted into the sixth apertures 197 of each of the third bodies 170a-b, respectively. In one embodiment, the second fixed aligner 196 is a single piece made of stainless steel spring metal. In one embodiment, the second fixed aligners 170a-b are made of a material that is strong enough to hold the distance "D2" during the hold/steady phase. The use of fixed aligner 196 instead of adjustable aligner during the hold/steady phase means that the implement is smoother and less bulky, allowing more room for the tongue to move during this phase. In addition, removal of the adjustable aligner after expansion is achieved is more hygienic. However, in other embodiments, the adjustable arch expander may be left in place after expansion is achieved without further adjustment to effectively act as a fixed aligner.
Fig. 11a-b are schematic illustrations of a bone-based fixed expander device incorporating an additional body. In some embodiments, the patient may need a certain amount of stability during maxillary arch expansion that some of the above-described embodiments may not provide most suitably, depending on the age, sex, bone density, or desired clinical outcome of the patient. Thus, in one embodiment, the bony stationary expander is provided with at least two additional bodies 165. In an embodiment, the body 165 includes an extension arm, rod, hard wire, or other structure configured to provide additional points of stability for the bony fixed expander without tooth support. In one embodiment, at least one body extends laterally from each first body 100a-b (see FIG. 11 a) or from each second body 151a-b (see FIG. 11 b). In one embodiment, one end of each body 165 is integral with each body 165 of the first body 100a-b or the second body, and the other end includes an attachment mechanism 164 configured to couple to the hard palate. In one embodiment, each attachment mechanism is configured to receive a fastener 163, the fastener 163 being configured to provide releasable coupling of the attachment mechanism to the hard palate. In embodiments, the fastener 163 may be a screw, rivet, pin, interference type mechanical biocompatible adhesive, or other dental fasteners known in the art. The use of body 165 provides additional points of attachment by which forces can be distributed to more bony fixation devices and to the palate.
Fig. 12a-c are schematic illustrations of a bone fixation type arch expander device that does not necessarily rely on the use of a pair of first bodies. In one embodiment, the bony stationary expander includes an adjustable aligner 151 or a stationary aligner 106. In one embodiment, the bone fixation expander includes a plurality of sixth fasteners 136. One bottom end of each sixth fastener 136 is configured to be inserted into the maxilla and the other opposite top end is configured to receive and couple the fixed or adjustable aligner 106, 150. In one embodiment, each sixth fastener 136 is defined by the spacing of the holes formed through the fixed aligner 106 in respective alignment and spacing relative to the other sixth fasteners coupled to the hard palate of the patient. In one embodiment, the tips of the sixth fasteners 136 initially couple the fixed aligner 106 via an interference fit with a recess formed in the bottom of the hole in the fixed aligner 106, each of the sixth fasteners extending from and being aligned with the hole after assembly. In one embodiment of use, the fixed aligner 106 and the sixth fasteners 136 are aligned and positioned against the upper jaw such that an equal number of the sixth fasteners 136 are located on either side of the jaw center seam. In one embodiment of use, each fastener is then coupled to the hard palate. In one embodiment, the bottom end of each sixth fastener 136 includes threads that pass through holes in the fixed aligner 106 for insertion into the hard palate by rotation with the top end of each fastener. In one embodiment used, the fixed aligner 106 is disengaged from the sixth fasteners 136 by removing the tips of the sixth fasteners from the recesses in the holes of the fixed aligner when each of the sixth fasteners 136 is inserted to the desired depth. In one embodiment used, the adjustable aligner 150 is coupled to the sixth fastener 136. In one embodiment, an attachment mechanism is provided with or disposed in each of the second bodies 151a-b that is sized to be spaced apart by a longitudinal spacing that is the same as the spacing of the holes of the fixed aligner 106 in the longitudinal direction. Is determined to be longitudinally spaced apart at the same longitudinal spacing as the first bodies 151 a-b. In one embodiment, prior to coupling the sixth fastener 136, the second bodies 151a-b are spaced apart using the adjustment mechanism 152 such that the attachment mechanism in the second bodies 151a-b has the same lateral spacing as the holes of the fixed aligner 106. In one embodiment, each attachment mechanism in the adjustable aligner 150 is configured to retain the adjustable aligner 150 when the adjustable aligner 150 is placed over the sixth fastener 136. In an embodiment, the attachment mechanism includes a hole, a snap-fit mechanism, an interference type mechanism, an adhesive, or a combination of the foregoing configured to allow the sixth fastener 135 to be coupled and uncoupled from the adjustable aligner 150. in one embodiment, the attachment mechanism includes holes in each of the second bodies 151a-b and seventh fasteners 135 provided together, wherein the seventh fasteners include fasteners and the top ends of the sixth fasteners 136 are provided with holes for receiving the bottom ends of the seventh fasteners 135. In one embodiment, the top end of the sixth fastener 136 and the bottom end of the seventh fastener 135 are threaded. In one embodiment used, after the adjustable aligner 150 is positioned over the sixth fastener 136, the seventh fastener 135 is inserted into the hole of the adjustable aligner and coupled to the sixth fastener 136. The adjustable aligner 151 can then be used to create an orthodontic expansion force to the sixth fastener 136 that is aligned for installation without the use of the first bodies 100a-b described above. In addition, sixth fastener 135 may be inserted into the upper jaw to a desired depth, in one embodiment, installation may be performed such that the tip of sixth fastener 135 protrudes a particular distance below the upper jaw, in which case one or more spacers 50 as described above may not be required to achieve the desired installation space/gap between adjustable aligner 150 and the tissue of the upper jaw. Although fig. 12a-b show four sixth fasteners 136 and seventh fasteners 135, it should be understood that other numbers of fasteners and attachment mechanisms may be implemented and used, such as six or more sixth and seventh fasteners, and six or more attachment mechanisms, respectively, may be used as desired or needed to distribute the forces experienced by the fasteners.
FIG. 13 is a schematic view of another embodiment of an alternative bone fixation expander device that does not require the use of a first body 100 a-b.
In another embodiment, without requiring the use of a pair of first bodies 100a-b as discussed above, each second body 151a-b includes a plurality of threaded fourth holes 198, the plurality of fourth holes 198 being configured to connect the second bodies 151a-b against the bottom and top surfaces of the hard palate. Although four threaded bores 198 are discussed herein, the present invention contemplates that other numbers of fourth bores may be configured in each second body 151a-b to better distribute forces and reduce stress on the screw and bone. In one embodiment of use, a pair of second bodies 151a-b are first coupled to the palate by inserting the bottom ends of the second fasteners 111 into the fourth holes 198, and then after insertion, the bottom ends of the second fasteners 111 are threaded into the hard palate. During insertion of the bottom end of the second fastener 111 into the hard palate, its top end is screwed into a corresponding threaded fourth hole 198 in the second body 151 a-b. In one embodiment, the spacer 50 may be used to create a distance between the pair of second bodies 151a-b and the upper jaw before the second fastener 111 is fully threaded into the upper jaw. In one embodiment, the pair of second bodies 151a-b may be coupled to or include an implement, arm, rod, hard wire, or other structure configured to provide additional stabilization points for the above-described bone fixation type archexpander when used without a pair of first bodies as described above.
The device of the prior art is compared with various embodiments of the present invention, including:
● Prior art devices an archer assembly that couples teeth by a molar band ring and that couples the upper jaw by 4 fasteners, each of which contains a single set of threads configured to screw into the upper jaw (i.e., the Moon device mentioned in the background section)
● Embodiment 1 an arching expander assembly using an adjustable aligner 150 coupled to the upper jaw by a pair of first bodies 100a-b and six fasteners 111, wherein each fastener comprises two sets of threads, and wherein one set of threads is threaded into the pair of first bodies and the other set of threads is threaded into the upper jaw (see fig. 2 b).
● Example 2 an arching expander assembly using an adjustable aligner 150 coupled to the upper jaw by a set of two bodies 120a-b (see fig. 6 b) and a pair of first bodies 100a-b and six fasteners 111, each of which includes two sets of threads (see fig. 2 b), one set of threads threaded into the pair of first bodies and the other set of threads threaded into the upper jaw (see fig. 2 b).
The following peak bone stresses were noted:
● 98MPa of prior art equipment
● Example 1:84mpa (reduced stress to fasteners and bone compared to the prior art).
● Example 250 MPa (reduced stress to fasteners and bone compared to the prior art).
The following peak maxillary stresses were noted:
● Prior art device 0.479
● Example 1:0.426 (providing a more uniform strain to the jaw center seam compared to the prior art).
● Example 2:0.397 (providing a more uniform strain to the jaw center seam compared to prior art and example 1).
Fig. 14 is a schematic view of a third securing fastener. In one embodiment, the third fixed aligner 1901 comprises a surgical guide configured to accurately position and fix a pair of first bodies 100a-b on both sides of a jaw center seam on the hard palate.
In one embodiment, a casting of the geometry within the patient's mouth is obtained, a mold is made from the casting, and an appliance in the form of a third fixed aligner 1901 is made from the mold, the surface of the appliance facing the upper jaw having features that match the upper jaw, and/or dentition of the patient. In another embodiment, a digital scan (e.g., a maxilla and/or CBCT scan of the maxilla) is performed by a computer-controlled imaging device, and an image of the patient's maxilla, jaw, and/or dentition is obtained and stored in computer memory (e.g., an STL format file). The stored images may then be used by third party printing or machining equipment to form a third fixed aligner 1901 that forms a mating feature with the patient's upper jaw, jaw bone and/or dentition against one side of the upper jaw. In one embodiment, the fixed aligner comprises biocompatible materials known to those skilled in the art to be suitable for use in the oral cavity. In one embodiment, the third fixed aligner 1901 includes an aperture 1936 formed in the third fixed aligner 1901 to guide the insertion of the second fastener 111 into the hard palate. In one embodiment, the aperture 1936 is formed along a peripheral recess 1937 formed in a third fixed aligner configured to receive the first bodies 100a-b. In one embodiment of use, after fitting onto the soft palate of a patient, the first bodies 100a-b and the fasteners 111 are guided with a third fixing aligner 1901 to positions on either side of the jaw center seam so that the fasteners 111 can be screwed into the hard palate until the threads at their tips are secured in the pair of first bodies. In one embodiment, the portion of the third fixed aligner 111 that engages the dentition may be inserted against the patient's dentition to minimize movement of the first body with respect to the maxilla when the fastener 111 is inserted. In one embodiment used, a third fixed aligner 1901 is used to define a space/gap between the first bodies 100a-b and the upper jaw. To obtain the desired space/gap, the third fixed aligner 1901 may be fabricated with a thickness of the region around the aperture 1936, for example, the space/gap is approximately 0.1-0.3mm, depending on the particular desired space/gap. The third fixed aligner 1901 may be made of a relatively rigid but brittle material, such as biocompatible acrylic, resin, or polycarbonate. In one embodiment, the third fixed aligner 1901 is provided with one or more thinned regions 1938 such that the fixed aligner can be removed by subsequent breaking at the thinned regions, thereby removing fragments of the aligner around the fasteners and under the pair of first bodies 100a-b, which allows for removal of the aligner without removing or unscrewing the fasteners 111.
Fig. 15a-c are schematic views of another third fastening device. In one embodiment, third fixed aligner 2001 is fabricated using the techniques discussed above with reference to third aligner 1901. In one embodiment, the third fixed aligner 2001 includes an alignment feature 2117 configured to receive a pair of first bodies 210a-b and a plurality of holes 2119 configured to receive a plurality of fasteners including fastener 2116 and fastener 2111. In one embodiment, the plurality of holes 2119 includes holes configured to match the spacing of the first fixed aligner 2106 and corresponding holes 2115 in the first bodies 2100 a-b. In one embodiment of use, the first body 2100a-b abuts and/or is on a feature 2117 on one side of the third fixed aligner 2001, the first fixed aligner 2106 abuts on an opposite side of the third fixed aligner 2001, and a fastener 2116 is inserted through a hole 2119 into a hole 2115 and into a hole in the first body to connect the first body and the first fixed aligner together to form an assembly with the third fixed aligner sandwiched between the pair of first bodies and the first fixed aligner. In one embodiment of use, the assembly is then placed against the upper jaw and the assembly is secured to the upper jaw using a plurality of fasteners 2111. In one embodiment used, the thickness T1 of the third fixed aligner 2001 in the region configured to receive the first bodies 2100a-b in feature 2117 is thicker than the thickness T2 of the pair of first bodies 2100a-b and such that the face of the first bodies 2100a-b facing the upper jaw in the assembly mounted to the upper jaw is spaced from the upper jaw by a distance that depends on the difference between the thickness of the third fixed aligner 2001 and the thickness of the pair of first bodies, such as a distance between about 0.1-0.3 mm.
In one embodiment, the third fixed aligner 2001 and the first fixed aligner 2106 include holes 2139, the holes 2139 being configured to have a size that allows the plurality of fasteners 2111 to be fully received therethrough and such that subsequently the second fixed aligner 2106 and the third fixed aligner 2001 can be removed by removing the fasteners 2116 while the pair of first bodies 2100a-b are secured to the hard palate by the fasteners 2111, the configuration being such that the pair of first bodies are spaced a distance from the upper palate and such that the adjustable aligner 150 can be coupled thereto. In one embodiment, the third fixed aligner 2001 is configured to be fixed to the dentition of a patient and sandwiched between the first bodies 2100a-b and the fixed aligner 2106 to hold the bodies against a particular location in the patient's mouth. The thickness of the first body 2100a and the counterbore formed therein act to further align the fastener 2111 so that the first body 2100a-b can be precisely mounted on the jaw and the fastener 2111 can be inserted into the hard palate.
Fig. 16a-d are schematic views of another bone fixation device. In some embodiments, because of the "v" shape, narrowness or restriction of the palate, it may be difficult to secure some of the embodiments described above in the patient's mouth, and for these and other shapes of the palate, the second threaded fastener 111 perpendicular to the palate may be difficult to secure in place due to the limited flat surface area.
In one embodiment, the bone fixation device includes a pair of first bodies 100c-d (see FIGS. 16 b-c). In one embodiment (see fig. 16 a), each of the pair of first bodies 100c-d includes a second aperture 102, respectively, the second aperture 102 defining a longitudinal channel that is angled (rather than parallel) with respect to the longitudinal channel defining the first aperture 101. This secures the pair of first bodies 100c-d to the pair of second bodies 151a-b in a similar manner as described in the other previous embodiments, but wherein the shaft of the second threaded fastener 111 inserted into the second bore 102 of one of the pair of first bodies 100c-d is angled with respect to the longitudinal axis of the second fastener inserted into the other of the pair of first bodies. In one embodiment, an extension 173 may be provided to the first body 100c-d to provide additional structural support for the second bore 102. In one embodiment, the pair of first bodies 100c-d having the extension 173 comprise a unitary element. In other embodiments, the first body 100c-d and the extension portion may be coupled together by various attachment means. It should also be noted that inserting the screw at an angle may have more surface contact with the bone than perpendicular insertion. Furthermore, it may be desirable to design the angled screw to be inserted into the jaw center slot in a different manner than the perpendicular screw. Although in the embodiment of fig. 16a-c, the first body is configured to mate with the second body along an extension 173 of the top surface that is non-parallel to the bottom surface of the first body. In other embodiments, the extension may be omitted such that the top and bottom surfaces of the first body are substantially planar and/or parallel to each other (see fig. 16 d).
In one embodiment, the angle of the longitudinal axis of the second bore 102 in each body 100c-d relative to the longitudinal axis of the first bore 101 is approximately between 0-90 degrees, depending on the palate shape and anatomy of the particular patient. In other embodiments, the angle of the longitudinal axis of the second bore 102 relative to the longitudinal axis of the first bore 101 is approximately between 0-60 degrees. In one embodiment, the angle of the longitudinal axis of the second bore 102 in one of the pair of second bodies 100c-d relative to the longitudinal axis of the second bore may be the same as the angle in the second first body 100 c-d. In one embodiment, the angle of the longitudinal axis of the second bore 102 in one of the pair of second bodies 100c-d relative to the longitudinal axis of the second bore may be different than the angle in the second first body 100 c-d.
While the embodiments discussed and described above have so far involved devices and methods for applying lateral force to treat a deficiency in maxillary development, the present invention determines that one or more embodiments may be used to apply forward traction to treat a deficiency in maxillary development.
In the above embodiments, it has been determined that a pair of second bodies 151a-b or third bodies 170a-b can be coupled to a pair of first bodies 100a-b, wherein in one embodiment, the apertures 197 in the pair of third bodies 170a-b are configured to be coupled to a spring wire 196 (see fig. 10 b), the spring wire 196 being used to maintain a lateral distance between the maxillary jaw middles. As shown in the embodiments below, the second and third bodies may also be configured to include apertures that may be coupled to an externally worn appliance within the mouth, such as an orthodontic facebow, which may be used to effect anterior movement and growth of the maxilla. In one embodiment, the appliance transmits one or more extraoral traction forces to a body that is intraoral mounted to the patient's maxilla in a manner that does not cause downward forward movement and growth of the maxilla, or equivalently only forward growth or a combination of forward and upward movement and growth.
Fig. 17a-c are schematic views of an orthodontic apparatus comprised of a pair of third bodies and an externally worn appliance coupled to the pair of bodies. In one embodiment (fig. 17a below), a pair of third bodies 2170a-b are coupled to the upper jaw via a pair of intermediate first bodies 2100a-b (not shown because they are located below third bodies 210a-b in fig. 17 a). In one embodiment, each of the pair of third bodies 2170a-b is configured to mate with each free end (denoted 2002 a-d) of the appliance 2002. In one embodiment, the mating is achieved by inserting the free convex end of the instrument into the recess 2197 of the pair of third bodies. In embodiments, the fit may be maintained by fasteners, interference fits, snap fits, slip fits, and/or other releasable couplings formed between the pair of third bodies 2170a-b and the free ends of the appliance 2002. In some embodiments, the aperture 2197 enables the appliance 2002 to be coupled and removed from the pair of first bodies 2100a-b simply and quickly. In some embodiments, the device 2002 is made of one or more stainless steels, ceramics, cobalt chrome, or other sufficiently strong materials.
In another embodiment, a pair of second bodies 2151a-b are coupled to the hard palate via intermediate first bodies 2100 a-b. In one embodiment, each of the pair of second bodies 2151a-b is configured to mate with each free end of the appliance 2002. In embodiments, the fit may be maintained by a fastener, an interference fit, a snap fit, a slip fit, or a releasable coupling formed between the pair of second bodies 2150a-b and the free end of the appliance 2002. In one embodiment, the mating is achieved by inserting the free male end of the instrument 2002 into a recess 2197 formed in the second body.
Fig. 18 is a schematic view of a pair of first bodies coupled to an externally worn appliance. In one embodiment, rather than coupling the appliance 2002 to the second body 2151a-b or the third body 2170a-b, the appliance is coupled to the pair of first bodies 2100a-b via fasteners 2198 provided to or in the first bodies. In one embodiment, the first body 2100a-b includes a bore similar to the bore 2197 described above.
Returning to fig. 17a, in one embodiment, the appliance 2002 comprises two first portions 2002a configured to extend laterally from each free end to a shape behind each final tooth (e.g., molar tooth) of the patient, after extending beyond the posterior teeth, the two first portions 2002a configured to be connected to a third portion 2002c by a curved portion 2002b, wherein the third portion 2002c is configured to extend from the curved portion generally along the opposing outer surfaces of the patient's teeth to a shape outside the patient's mouth, and the two third portions 2002 are configured to be joined together in the form of an integral or non-integral fourth portion 2002d or directly outside the patient's mouth. In another embodiment, instead of extending laterally behind the distal teeth, the first portions 2002a may be configured such that they can plug into the shape of the existing crevices. In other embodiments, the shape of one or more portions of the appliance 2002a is tailored to match a particular geometry of the patient.
Fig. 19a-b are schematic views of other externally worn orthodontic appliances. In one embodiment, the appliance 2002 includes a fifth portion 2002e. In one embodiment, the fifth portion is coupled to and extends from the center of the fourth portion 2002d in a generally orthogonal and upward direction relative to the fourth portion. In one embodiment, the fifth portion 2002e rigidly couples the fourth portion 2002d, for example, by brazing, welding, or other fixed coupling mechanisms known to those skilled in the art. In one embodiment, the fifth portion 2002e is configured with two branches that extend upward from the fourth portion 2002d and are recombined together above the fourth portion 2002d, the two recombined branches forming a hole and extending to the terminal. In one embodiment, the fifth portion 2002e comprises at least one point of application 2002n in the form of a hook, loop (see fig. 19 a), depression (see fig. 19 b), or other attachment mechanism to which a spring or other external force portion from an externally worn traction frame or device may be coupled. In one embodiment, the fifth portion 2002e is configured to extend upward such that little or no interference with the patient's nose occurs during use.
Fig. 20a-b are schematic illustrations of an external force applied to an externally worn appliance. As determined by the inventors of the present invention, when external traction is transmitted to the tool and through the tool to a pair of bone anchors mounted to the maxilla, the application of a forward or forward and upward force can be used to achieve forward-only growth, or forward and upward growth, wherein such force does not or minimally produces a rotational moment of the maxilla anchor attachment point. The present invention determines that upward or generally upward movement and growth of the maxilla can also be achieved when forward or forward and upward traction is applied to an implement associated with a pair of bodies of the hard palate of the maxilla, the rotational moment of the pair of first bodies 2100 a=b coupled to the maxilla is eliminated or minimized. The present invention determines that when an external oral force is applied to an appliance and to a pair of bodies (e.g., see first bodies 2100a-B in fig. 20 a) coupled to a maxilla (e.g., hard palate) in a direction past a point of application of force on the appliance (e.g., see points a, B and/or C), rotational torque imparted to the pair of bodies and the maxilla can be minimized or eliminated. In one embodiment, referring to a patient standing in a forward direction, when 1588gm of force is applied to the tool along an axis at an angle of 60 degrees to the horizontal through the point of application "C" on the tool and the point of application "D" on the pair of first bodies, the patient's maxilla can be caused to undergo the desired forward-only growth and movement. Other forces, angles and other locations on the instrument are within the scope of the invention, depending on the particular bone geometry of the patient and/or the particular desired distance of movement or growth of the patient's maxilla, provided that the forces applied to the instrument are aligned according to the above-described embodiments and a pair of bodies. For example, as shown in fig. 20b, traction force may be applied to the fifth portion 2002e at other locations 2002n, so long as the direction of application of force passes generally centrally through the pair of first bodies and past the point of application of force on the implement.
Figures 21a-b are schematic illustrations of another externally worn orthodontic appliance and its use. In one embodiment, each third portion 2002c of the appliance 2002 extends generally along opposite outer surfaces of the patient's teeth and is formed from an intraoral portion 2002p and an intraoral/extraoral portion 2002q coupled to intraoral portion 2002p by a releasable joint 2002f, e.g., by a releasable joint formed from hooks, loops, a snap fit, a slip fit, an interference fit, and/or other similar interlocking elements formed at the ends of intraoral and intraoral/extraoral portions. In one embodiment, when the appliance 2002 is used in the oral cavity, the intraoral/extraoral portion can be separated from the intraoral portion by a releasable joint 2002f as needed or desired (e.g., when the external appliance is not intended to be worn in public). While fig. 21a-b illustrate the appliance with one tab 2002f on each side and coupled thereto, it should be understood that in other embodiments the appliance may include more tabs and thus more releasable portions than the illustrated appliance.
Thus, when the pair of first bodies 2100a-b, second bodies 2151a-b, or third bodies 2170a-b are used simultaneously with the orthodontic appliance 2002, it is determined that forward or forward and upward movement and growth of the patient's maxilla can be achieved in addition to lateral expansion and growth of the maxilla. In one embodiment using third bodies 2170a-b, it is further determined that unilateral movement and growth may be achieved in addition to bilateral movement and growth of the maxilla. It is also determined that the use of first body 2100a-b, second body 2151a-b, and third body 2170a-b eliminates the need to perform invasive surgical procedures such as are required for other devices. It is further determined that aspects of the present invention are well suited for use with externally worn appliances while a patient is sleeping, as it can be configured to be positioned only over and through the shape of the patient's face anatomy, thus minimizing the impact on side sleep.
The foregoing embodiments have been described in some detail for purposes of clarity of understanding, and the described embodiments are to be considered as illustrative and not restrictive. It will be apparent to a person of ordinary skill in the art that certain changes and modifications may be practiced within the scope of the appended claims.
For example, one or more features from any embodiment may be combined with one or more features of any other embodiment without departing from the scope of the disclosure. Further, modifications, additions or deletions may be made to any of the embodiments without departing from the scope of this disclosure. In addition, other dimensions and other materials besides those disclosed may be used, provided they are compatible and sufficiently robust for use on a person. Moreover, while the described embodiments of the present invention can be used without the need to couple teeth or molar belt loops, it should be understood that the use of belt loops is not precluded and the present invention can be adapted to be used with belt loops if desired. Furthermore, although the embodiments of the present invention are described as orthodontic appliances for treating orthodontic conditions, their use is much greater, for example as a medical device for treating non-obese obstructive sleep apnea caused by hypoparathyroidism, or in conjunction with other surgical procedures that can be performed by craniomaxillofacial surgeons, which may be within the scope of medical insurance, rather than just dental insurance.