Skull reconstruction device

Abstract

A device for skull reconstruction by expansion, compression or bending of a skull structure located between a first anchor point and a second anchor point, the device comprising: a force generator configured to generate a force; a first anchor for attachment to a first anchor point; a second anchor for attachment to a second anchor point; and a hydraulic force transmission structure connected to the force generator and configured to transmit a force to the first anchor and the second anchor to place the skull structure in at least one of stretching, compressing, or bending, where the force transmission structure is the hydraulic force transmission structure.

Description

[0001] This application is a divisional application of the invention patent application with the application date of June 19, 2020 and the application number of 202080057958.8. Technical Field

[0002] The present invention relates to a device for achieving skull and / or orthodontic reconstruction mainly through the action of periodic forces. Background Art

[0003] As is well known, dental devices or systems such as braces, intraoral appliances, retainers, etc. can be used to reposition teeth and modify the dental arch of a user. These work by applying a constant static force to the teeth to which they are attached. More precisely, since the force applied to the teeth is constant, as the teeth change position, the force received by each tooth decays over time.

[0004] In many cases, the device must be worn 24 hours a day, such as fixed braces, and continuously apply force to the user's teeth in order to produce any meaningful effect. This can become uncomfortable for the user. A similar situation occurs when attempting to correct the facial bone structure of the user. This typically requires a bulky support structure, such as a headgear, which can be removable or fixed in the form of a skull traction device. In the case of a fixed device, it usually requires a wear time of more than 12 hours or continuous use. Summary of the Invention

[0005] Broadly speaking, the present invention aims to solve this problem by providing a device configured to apply periodic forces to bones, teeth, or other parts of the body in order to reshape their structure, for example, by expansion, compression, or protrusion. As described below, in some cases, the applied periodic forces are superimposed on static forces to increase efficacy.

[0006] The first aspect of the present invention mainly relates to a device configured to perform reconstruction of the maxilla, mandible, dental arch, or palate. However, it should be understood that the device according to an embodiment of the first aspect of the present invention can be used for other types of skull reconstruction. More specifically, the first aspect of the present invention is achieved by providing a device for skull reconstruction by expansion, compression, or bending of a skull structure located between a first anchor point and a second anchor point, the device comprising:

[0007] A force generator configured to generate periodic forces;

[0008] A first anchor for attaching to the first anchor point;

[0009] A second anchor for attaching to the second anchor point;

[0010] A force transmission structure that is connected to a force generator and configured to transmit a periodic force to a first anchor and a second anchor, thereby subjecting the cranial structure to at least one of: tension, compression, or bending. It is recognized that there may be more than two anchors, and one anchor point can constitute a set of structures.

[0011] It has been shown that applying a dynamic force to a bone structure results in greater bone growth compared to a static force. The combination of static and dynamic forces has also been shown to accelerate tooth movement. This is advantageous as it reduces treatment time and minimizes the amount of pain / discomfort experienced by the user. It also minimizes or eliminates the need for long-term wear of static orthodontic appliances or oral appliances / retainers.

[0012] Throughout this application, it is understood that the force applied to a tooth can also cause compression and tension of intermediate structures such as the periodontal ligament, and under different loading regimens, the effects on tooth movement and bone remodeling will be different. It should also be understood that the cranial structure and sutures may be subjected to different amounts of compression and / or tension, depending on the loading regimen.

[0013] Preferably, the force generator is an external force generator. In other words, in use, the force generator is preferably located or can be located outside the user's body. The "periodic force" here can refer to a cyclic force (i.e., a force that is periodic and has a constant frequency or period), but should also be understood to include a quasi-periodic force, where for example the frequency or time period varies. Alternatively, the force can be a variable force with a variable time period. For the cyclic frequency, the preferred frequency is in the range of 1 to 400 Hz, and in embodiments where the frequency varies (i.e., a quasi-periodic force), the frequency preferably varies between 1 Hz and 400 Hz. Preferably, the waveform of the periodic or quasi-periodic force is one of: triangular, sinusoidal, sawtooth, spiked, or square. The force can also be any superposition of these. Other periodic waveforms should be understood to be included in this definition.

[0014] The periodic force is preferably a unidirectional force. In other words, the action of the periodic force is preferably not a "push-pull" action, but a push or pull action that varies periodically (or quasi-periodically) over time. In this way, the force applied to the major cranial structure causes remodeling in only a single direction. The force generator can be configured to generate forces other than periodic forces, such as continuously varying forces or constant forces or combinations thereof. Specifically, the profile of the force generated by the force generator can include periodic and aperiodic regions, as well as regions where no force is applied. For example, in some embodiments, the force generator can be configured to generate a force having a profile with alternating periodic and aperiodic regions. In some embodiments, the aperiodic region can include a constant force, while in other regions, the aperiodic region can include a linear or otherwise increasing / decreasing force. In a preferred embodiment, the periodic / quasi-periodic portion of the force preferably oscillates about a non-zero force. Preferably, when the force oscillates about a non-zero force, the minimum value of the oscillation is not below zero. In this way, it can be ensured that the force is always applied to the major cranial structure under discussion. This is in contrast to a force that oscillates about zero, where for approximately half the time, no force may be applied. In some embodiments, the force characteristics (e.g., duration, magnitude) can be adjusted based on continuous or intermittent input from a data processor, which is arranged to receive input from a measuring device, such as a manometer, a strain gauge, a device for measuring the displacement of the cranial structure or other body structure. Other forms of input are also covered, such as electrocardiogram (ECG), electroencephalogram (EEG), and electromyogram (EMG). In this way, the device can operate as a feedback system. In some cases, the feedback can come from the operation of one embodiment, informing the activity of one or more other devices. A constant dispersion speed can be achieved by using a combination of hydraulics and displacement feedback mechanisms.

[0015] It should be noted that throughout this application, we refer to "constant force" or "static force". When a constant force is applied to, for example, a tooth or other cranial structure, over time, the force will cause the structure to move in the direction of the constant force. The force at contact is preferably constant.

[0016] If the force is provided by, for example, a taut line or an inflatable structure, then the tension in the line (or inflatable structure) will decrease as the structure moves, i.e., the static force will decrease very slowly over time. Throughout the present application, these forces are still referred to as "static forces" or "constant forces", although they change gradually over time. Throughout the present application, the terms "constant force" and "static force" should still be considered to include forces that vary by a negligible amount, or not at all, on the time scale of one period of a periodic force. An actuator with a feedback loop can generate a "true" constant force. As the structure moves, the pressure in the system drops and is corrected to its initial value, thus maintaining a constant force. After one correction or a series of corrections, the contact surface area between the anchor and the anchorage may change.

[0017] In some cases, there may be two ways to apply a force to the first anchor or the second anchor. Specifically, a first component can apply a static force to the first anchor and / or the second anchor, and a second component can apply a periodic force to the first anchor and / or the second anchor. In this way, a constant "background" force can be applied, and the periodic force generated by the force generator can be superimposed thereon. Preferably, the force provided by the first component is adjustable, for example, by a screw. The first component can be in the form of a well-known oral appliance, such as a static bracket, a retainer, or a rapid maxillary expander. In this case, when the user wears the device, the cranial structure to be reconstructed is subjected to a constant static tension or tensile force. For example, if a user who needs maxillary arch expansion wears such a device, the device can apply a constant force to the upper teeth in a laterally outward direction, which acts on the teeth to stretch the palate and bend the maxilla, thereby causing a gradual lateral maxillary expansion.

[0018] When the device includes a static force generating component, the force generator does not need to generate a periodic force with such a large amplitude, because the periodic component of the force is superimposed on the static component of the force provided by the static component. Alternatively, the force generator can generate all or part of the static force as well as the periodic component. The static component is preferably shaped to expose the first anchor and the second anchor to the first anchorage and the second anchorage, respectively, to ensure that the anchors can be attached to the anchorages for effective force transmission. For example, the static component can include holes or windows. Alternatively, the static component can include means for connecting it to the rest of the device in use to ensure that the components of the force add constructively, rather than, for example, cancel each other out. Embodiments of the present invention in which the device includes a static component ensure that the force generated by the superposition of the static and periodic components of the force is always positive, i.e., acts in the correct direction to effect the desired reconstruction.

[0019] Embodiments of the present invention are adapted to perform skull reconstruction by effecting expansion, compression, or bending of skull structures. For example, in some embodiments, the device can be used for mandibular or maxillary expansion, where the mandible / maxilla expands laterally as well as forward. Alternatively, the device can be used for maxillary or mandibular protrusion, where the mandible / maxilla moves forward, such as the bone being discussed. Forward movement can also stimulate growth by subjecting the bone to strain. In some embodiments, other movements can be effected, such as retraction of teeth or the maxilla. This also includes medial or more generally inward movement of the teeth. In some embodiments of the present invention, movement of one or more teeth along or around any axis or combinations thereof such as rotation is also possible. Note that in some applications of the present invention, the desired effect is movement of two skull structures (e.g., maxillary expansion, where movement of both the left and right sides of the maxilla is desired, i.e., bone displacement, whereby the left and right sides of the maxilla are separated by detachment of adjacent sutures, or simply further separated in the absence of or with insignificant suture fusion), while in other applications, the desired effect is movement of one skull structure (e.g., maxillary protrusion, where the desired result is forward movement of the maxilla). However, the mode of operation in both cases is actually the same, as both are achieved by expanding some skull structures in order to increase the distance between two fixed positions on the skull. This equally applies to compression and bending actions. In addition to those mentioned in this paragraph, the present application also covers various different uses of the present invention. It can be appreciated that the structures being discussed can be treated asymmetrically, for example, asymmetric treatment can be performed on one side of the maxilla, with or without suture separation.

[0020] The device of the present invention works by transmitting a first force to a first anchor and a second force to a second anchor, where the direction of the first force is opposite to, or substantially opposite to, that of the second force. In embodiments where the first force or the second force is applied over a large area (e.g., between a head plate and the back of the head), the net effect of the first force is opposite to, or substantially opposite to, the net effect of the second force. In some embodiments, the force transmission structure is configured to directly apply only the first (periodic) force to the first anchor. In those embodiments, the first force is transmitted via the skull structure to the second anchor, and the skull structure experiences a second force as a reaction force, which has the same magnitude (or substantially the same magnitude) as the first force but in the opposite direction. As is well known to those skilled in the art, applying two forces in opposite directions to a skull structure through two anchor points creates tensile or compressive forces in the skull structure, and then the desired skull reconstruction is achieved. In some embodiments, for example, when the skull structure is not located on the straight line connecting the first and second anchor points, the opposite first and second forces can alternatively create bending of the skull structure. This equally applies to the case where the periodic force is applied only to the second anchor, but for the sake of brevity, we will not repeat the description here.

[0021] In other embodiments, the force transfer structure is configured to directly apply a periodic force to the first anchor and the second anchor. Specifically, the force transfer structure is configured to directly apply a first force to the first anchor and a second force to the second anchor. As described above, preferably, the first force and the second force are equal in magnitude and opposite in direction so as to create tension or compression in the cranial structure located between the first and second anchor points.

[0022] Above, we discussed the mechanics of force transfer to the first and second anchors. Now we discuss the nature of these forces and their transfer to the first and second anchors through the force transfer structure. In some embodiments, the force generator includes a motor configured to produce rotational motion, such as a stepper motor. In this case, the force generator preferably further includes means for converting the rotational motion into reciprocating motion. These means can include a crank, a thread, or a cam. As is known to those skilled in the art, there are numerous other components available for achieving such a conversion. As discussed, the force generator is preferably an external force generator, and as is evident, the first and second anchor points are typically located within some cranial structure of the user, such as the mouth or nose. Therefore, the force transfer structure is preferably configured to transfer a periodic force from outside the user's body to inside the user's body. Specifically, in a preferred embodiment of the present invention, the force transfer structure is configured to direct the force in the anteroposterior direction, i.e., along the anteroposterior direction with respect to the user's body. Note that in some embodiments, the periodic force can be generated in this direction, in which case the force transfer structure only needs to maintain the direction, but in alternative embodiments, the force can be generated, for example, in the up-down direction, and the force transfer structure includes a mechanism for changing the direction of the force. The force generator can be located within a housing configured to be attached to a harness. In some embodiments, the harness can be a chest harness.

[0023] The force transfer structure can include one or more inextensible and incompressible lines configured to transfer the generated periodic force as tension. However, in a preferred embodiment of the present invention, the force transfer structure is a hydraulic force transfer structure that utilizes the incompressible property of a fluid such as water or oil to transfer the force generated by the force generator as a compressive force. The hydraulic force transfer structure preferably includes one or more expandable / contractible structures, such as air bladders or bellows, that can be inflated with fluid in order to transfer the periodic force to the first or second anchor. Specific embodiments of the present invention employing a hydraulic transfer structure will be described later in this application. The hydraulic force transfer structure is particularly effective because they have been shown to reduce potential mechanical system sprains. In other embodiments, the force transfer can include or be in the form of a pneumatic or piezoelectric force transfer structure.

[0024] In some embodiments of the present invention, the device may be modular. In other words, any one or all of the force generator, the force transfer structure, the first anchor, and the second anchor may be removed from the device such that they may be replaced with alternative components. In other embodiments, a portion of the device may be fixed or configured to be fixed to the skull structure of the user and may be connected to the remainder of the device. For example, at least one of the force transfer structure, the first anchor, and the second anchor may be fixed or fixable to the skull structure of the user and may be connected to the force generator. This modular structure is advantageous because it means that the fixation structure can be more firmly fixed, for example, by surgical implantation or attachment, which will result in a more efficient transfer of force from the force generator to the skull structure to be reshaped or reconstructed.

[0025] The modular structure is advantageous, for example, when the generation of force is not required, the force transmitter and the force generator may be detachable, and in some embodiments, the force may be self-sustaining or depleted. As a result, the dwelling trace structure remains as compact and unobtrusive as possible, improving patient comfort and minimizing complications such as entanglement and other forms of accidental injury.

[0026] The modular hydraulic force transfer structure is particularly advantageous because in some embodiments it allows a single hydraulic force generator to be removably connected to multiple different parts of the force transfer structure in order to individually adjust the forces exerted by each different part. Again, this refers to valves or other forms of detachable but self-sealing / sealed connections, such as check valves or reversible valves. The valve can be within the device body near the oral appliance or extend therefrom shortly. If the conduit leading out of the mouth does not protrude, the valve can be located closer to the hydraulic force generator. The valve allows the force transfer member to be separable at any point along its length. When the device is not in use, the force transfer member may protrude and can be detached from its connection via the self-sealing valve or can be separated on its own. This is not only convenient but also reduces the risk of iatrogenic injury. The self-sealing valve allows the pressure in the system to be maintained. This pressure generates our retention force, which decays over time, like our wire under tension. Advantageously, the system can be "reset" multiple times a day (intermittently), thus maintaining the pressure and thus the force on the teeth. Alternatively, as the cranial structure is displaced or remodeled and thus the effective force / pressure on the structure decreases, the device can be configured to increase the force provided by the force generator to ensure a constant force is maintained on the cranial structure. According to an exemplary embodiment, the self-sealing valve can be configured to allow a hydraulic fluid delivery hose or conduit to be connectable to and disconnectable from a first hydraulic force transfer structure portion. The first end of the hose can be fluidly connected to the hydraulic force generator and the second end of the hose can be configured to reversibly connect to the first hydraulic force transfer structure portion. The hose can also be reversibly connected to a second hydraulic force transfer structure portion. When the hose is disconnected, the self-sealing valve can be configured to maintain the pressure of the hydraulic fluid in the force transfer structure portion. The modularity of the device components means that a single hydraulic force generator can be used to adjust the forces exerted on the user's cranial structure by multiple force transfer structure portions. Thus, the modularity of the device eliminates the need to operate multiple hydraulic force generators, thereby reducing the cost of the system. In cases where the device is required to exert simultaneous and different force characteristics, multiple hydraulic force generators can be used. The hydraulic force generators can be separate units that can be connected together or housed within a single housing / single enclosed unit.

[0027] The above disclosure of the invention is general and not related to applying periodic forces to a specific cranial structure. Now, we turn to some specific applications of the device.

[0028] In some embodiments, the device is configured to perform maxillary or mandibular expansion, which may refer to widening of the dental arch due to tooth movement or widening due to displacement of bony portions, which may be naturally occurring, created by using the device or surgical split sutures. In such cases, the first and second forces cause outward bending of the jaw in question, and expansion of the upper / lower surfaces of the mouth, even if the mandible or maxilla is not very curved. It is recognized that structures configured to receive forces (directly or indirectly) from such a device may be subject to compressive or tensile forces. There are many different ways to achieve maxillary expansion using the device of the present invention. In some embodiments, the first anchor point and / or the second anchor point may be teeth. For example, the first anchor and / or the second anchor may include wires, bands, or other orthodontic fixtures configured to wrap around teeth, or plates / wires configured to abut or engage the inner or outer surfaces of teeth. In embodiments where the first anchor point and the second anchor point are a first tooth and a second tooth respectively, preferably, the first tooth is symmetrically opposite the second tooth in the user's mouth. In some embodiments, the first anchor and / or the second anchor may include a molded plate shaped to conform to the inner surface of one or more teeth of the user to provide a tight fit and thus more effectively transmit force. Alternative arrangements of the anchors may be employed depending on the shape of the dental arch and the desired clinical outcome. In some embodiments, the first anchor and / or the second anchor may be a combination of the above features. In other embodiments, the first anchor point and / or the second anchor point may be locations on the soft tissue of the user's mouth. In such embodiments, the first and / or second anchor may include screws or equivalent fasteners configured to directly contact bone or soft tissue. By contacting the tissue more directly, the force can be transmitted more effectively.

[0029] According to an exemplary embodiment, the device may be in the form of, or include, an expansion mechanism that may be configured to perform maxillary or mandibular expansion. The expansion mechanism may be configured to be disposed at a generally central location on the upper surface of the user's mouth. The expansion mechanism may include a central component, a hydraulic component, a channel component, and an attachment component. According to an exemplary embodiment, the central component may be adjusted by rotating a threaded portion relative to the channel component such that it applies a constant force to the patient's cranial structure through the attachment component. This force defines the background static force. Then, in use, an external hydraulic pressure generator is used to periodically expand and contract the hydraulic component. When the hydraulic component expands, it applies an additional force to the user's cranial structure through the attachment component. The additional force may be a periodic force. When this occurs simultaneously, the region of the user's cranial structure disposed between the two attachment components is subject to a tensile force that promotes maxillary expansion.

[0030] The central component can be configured to displace itself relative to the channel component. Alternatively, the central component can be configured to cause a separation between the first channel component and the second channel component. The central component can include an elongate member having a threaded portion configured to be received within a threaded bore of the channel component. The elongate member can be configured such that rotation of the threaded portion causes displacement of the central component and the attached component in a direction parallel to the longitudinal axis of the elongate member. Accordingly, the elongate member can be configured to apply a static force on the channel component configured to engage the threaded portion. The elongate member can include first and second threaded portions disposed at opposite ends of the elongate member and configured to engage each of the first and second channel components, respectively.

[0031] The central component can further include an alignment rod extending between the first and second channel components, which can be configured to maintain their alignment when the channel components move relative to each other due to rotation of the threaded portion. The central component can include two or more alignment rods. The first and second alignment rods can be disposed on either side of the elongate member to ensure proper alignment of the components.

[0032] The alignment rod can be cylindrical (i.e., having a circular cross-section). It should be appreciated that the alignment rod can be configured to have any one of square, rectangular, oval, and hexagonal shapes or any other suitable shape. The alignment rod can be configured to have a circular-rectangular cross-section, including, for example, a rounded-corner cross-section.

[0033] The channel component can be configured (i.e., shaped and / or arranged) to accommodate a hydraulic component. The channel component can include one or more holes configured to receive the ends of the alignment rods of the central portion. The hydraulic component can include an expandable structure, such as an airbag. The expandable structure can include an elongate substantially cylindrical airbag having a conical or frustoconical tip at its distal end. The proximal end of the airbag can be connected to a tube, hose, or conduit configured to supply hydraulic fluid to the airbag. When the airbag is in place within the channel component, the outer edge of the airbag can be aligned with the outer wall of the channel component or extend beyond the outer wall.

[0034] The attachment member can be configured to attach the expansion mechanism to the patient's cranial structure. Specifically, the attachment can be configured to attach at least one of the channel member and the central member to the cranial structure. The attachment member can include a molded structure that is shaped to match the contour of the patient's upper jaw and / or teeth to form a tight fit therewith. The attachment structure can include a fastening that is removable from the molded structure so that, for example, a single expansion mechanism can be removably attached to a variety of different molded structures and fittings. The attachment member can include fastening means configured to attach the expansion mechanism directly to the cranial structure. The fastening means can include one or more bone screws. Thus, the attachment member can define at least one of the first and second anchors. The screw can include a round or domed head that is configured not to provide any sharp edges that could damage soft tissue. The top surface of the domed screw can include a hexagonally formed hole or recess that can be configured to enable the screw to be turned with a hexagonal tool.

[0035] The attachment member can include wings or feet extending from the body of the attachment member. The wings can include holes configured to receive the fastening means. The holes can include positioning slots configured to releasably attach the wings to the screw. The positioning slots can include two intersecting round holes or apertures. The first larger hole can be configured to be larger than the diameter of the screw head. The second smaller hole can be configured to be larger than the diameter of the screw shaft and smaller than the diameter of the screw head. The size of the first hole can allow the head of the screw to pass through the first hole. The second hole can be configured to receive the shaft of the screw when the attachment member is disposed in the desired portion in the user's mouth. The underside of the domed screw can be configured to engage the chamfered edge of the second hole of the positioning slot. The wings can be substantially aligned with the base of the body, and the wings can be configured to extend in a plane substantially parallel to the base of the body. The wings can be integrally formed with the body of the attachment member. The attachment member can include a plurality of wings. The wings can be disposed at the distal corners of the body of the attachment member. The attachment member can be integrally formed with the channel member.

[0036] The cover can be arranged to form a protective shield over at least a portion of the expansion mechanism. The cover can be arranged to shield at least one of the hydraulic components, the attachment member, and the central member. The cover protects the patient's soft tissue from direct contact with the features of the expansion mechanism. For example, the cover can be arranged to prevent the patient's tongue from contacting any movable parts of the expansion mechanism. For example, when in use, the hydraulic components can be configured to cause periodic displacement of the movable parts, which can cause injury or discomfort to the patient.

[0037] In other similar embodiments, the device can be used for anterior expansion of the maxilla or mandible, i.e., forward growth of the maxilla or mandible, such as correcting the lower or upper palate. In an embodiment where the device is used for anterior mandibular expansion, the device can include a portion having a component arranged to be connected to a bone screw fixed to the inner surface of the mandible. In some embodiments, the first and second forces cause growth and / or displacement and remodeling of the upper / lower surfaces of the oral cavity and the maxilla / mandible itself in the anteroposterior direction (forward-backward). In these embodiments, the first anchor point can be one or more teeth. In such a case, the first anchor can be in the form of a wire, band, or other orthodontic fixture configured to wrap around one or more teeth, or in the form of a plate or wire configured to abut or engage the posterior surface of the anterior teeth. Alternatively, the first anchor can include a molded plate shaped to conform to the back of the teeth to provide a tight fit and thus more effectively transmit the force. The second anchor point can be a point on the soft tissue of the user's upper or lower palate located behind the first anchor point, and the second anchor can include a screw or equivalent fastener configured to directly contact bone, teeth, or soft tissue. By contacting the tissue more directly, the force can be transmitted more effectively.

[0038] In the above embodiments, there are two main ways in which the force generated by the force generator can be effectively transmitted to the first and second anchors. As described above, the force transmission structure can be in the form of a hydraulic force transmission structure. Alternatively, a method including solid components configured to convert one type of motion into another type of motion, i.e., without hydraulic components, can be used. Throughout this application, this will be referred to as a mechanical force transmission structure. In some embodiments, there can be a hybrid of hydraulic and mechanical force transmission structures.

[0039] As described above, preferably, the periodic force remains in the anteroposterior direction or is converted into a force in the anteroposterior direction. However, in order to mainly achieve lateral or lateral maxillary or mandibular expansion, the periodic force (and optional static component) of the force needs to be in the lateral direction. Therefore, the force transmission structure preferably includes a mechanism for rotating the direction of the force by about 90°. Here, "about 90°" should also be interpreted as covering exactly 90°. In addition, in some embodiments, the force must be transmitted to the first anchor and the second anchor. The force transmission structure can include a mechanism for converting the periodic force into a first force that is about 90° with respect to the periodic force and a second force that is about 90° with respect to the periodic force and has a direction opposite to that of the first force. The force transmission structure preferably includes a first force transmission member arranged to transmit the periodic force from the force generator to the anchor, and the first force transmission member includes one or more of a wire or a piston. Specifically, the force transmission member is configured to transmit the force in the form of a linear reciprocating motion or to periodically oscillate the linear tension using a thread. Specifically, the mechanism can be configured to convert the linear reciprocating motion into an oscillating rotational motion of a rotating member. The rotating member can include a first thread. The mechanism can also include a first threaded member having a second thread at least at the proximal end, and the second thread is complementary to and engages with the first thread. The distal end of the first threaded member preferably contacts the first anchor. The rotating member and the first threaded member are preferably arranged such that the rotation of the rotating member is converted into a reciprocating linear motion of the first threaded member through the engagement between the first thread and the second thread. Then, the periodic force is transmitted to the first anchor through this reciprocating linear motion. The rotating member can have a third thread opposite in sense to the first thread, and the mechanism can include a second threaded member having a fourth thread that is complementary to and engages with the third thread. The mechanism can also include a second threaded member having a third thread opposite in sense to the second thread. The distal end of the second threaded member preferably contacts the second anchor. The rotating member and the second threaded member are preferably arranged such that the rotation of the rotating member is converted into a reciprocating linear motion of the second threaded member through the engagement between the third thread and the fourth thread. Then, the periodic force is transmitted to the second anchor through this reciprocating linear motion. Alternatively, the same effect can be achieved by providing a first rotating member and a second rotating member. In other embodiments, the mechanism can include one or more worm gears and pinions, or ball and socket joints, in order to achieve the same effect.

[0040] Other embodiments employ a hydraulic transfer structure that includes one or more expandable structures, such as balloons, bellows, or other equivalent components. In these embodiments, the force transfer structure preferably includes channels or chambers containing a hydraulic fluid and pistons configured to move the fluid throughout the channels or chambers, thereby causing the expandable structures to expand or collapse. In some embodiments, there is a first expandable structure rigidly connected to the first anchor (e.g., via a first rod or other rigid body) and a second expandable structure rigidly connected to the second anchor (e.g., via a second rod or other rigid body). The expandable structures here can be in series (i.e., in fluid communication with each other), or can be separate components removably or permanently attached to separate rigid bodies. Here, rigid connection should be understood to mean that the two features are connected by a non-bendable and / or non-compressible connector. The expandable structures can be located within grooves or channels. When the first and second expandable structures expand, the expansion forces (i.e., the periodic forces transmitted, for example, by the pistons) are transmitted to the first and second anchors, respectively. Alternatively, a single expandable structure can be rigidly connected to the first and second anchors such that expansion of the single expandable structure transmits periodic forces to the first and second anchors. The rod or each rod can be cylindrical (i.e., having a circular cross-section). Alternatively, each rod can include a cross-section of any one of square, rectangular, oval, and hexagonal or any other suitable shape. The rod or each rod can be configured to have a circular-rectangular cross-section.

[0041] Using a hydraulic transfer structure such as that described in the previous paragraph, the direction of the periodic force can be more easily changed through proper orientation of the rigid connectors and expandable structures. For example, the hydraulic transfer structure can be used for maxillary / mandibular expansion, anterior expansion, or maxillary / mandibular protraction through proper arrangement of the expandable structures and rigid connectors. Above, the term "rigid" should be understood to mean that a component such as a connector is non-compressible over the length of the device on the scale of the device, ensuring that the force applied to one of the components is substantially equal to the force transmitted to the opposite end of the component.

[0042] In other embodiments, the expandable structure can be in direct contact with the first anchor and / or the second anchor. Alternatively, the first anchor and / or the second anchor can be formed by the expandable structure. For example, the device can include multiple expandable structures, each configured to abut or engage a cranial structure, such as a tooth or other feature of the mouth. In some embodiments, when one or both of the first and second anchors include a molded structure or plate, one or more expandable structures can be located on an outer surface of the molded structure that is configured to face, abut, or engage an inner or outer surface of a tooth. It is recognized that one or more expandable structures can be located on any surface of the molded structure. It is recognized that the molded structure can define a structure configured to conform to a corresponding surface of the patient's oral cavity, such as a portion of the palate and / or an inner surface of a tooth, and / or a bone interface.

[0043] The molded structure can be configured to be fixed to the top of the user's oral cavity using fastening means such as bone screws in use. Thus, as described above, the fastening means can define at least one of the first and second anchors. At least one molded structure can be configured to engage with the fastening means so as to fix the molded structure to the patient's cranial structure. The molded structure can be configured with holes or openings which are arranged to receive the fastening, such as bone screws. The openings can be arranged at the edge of the molded structure and configured to be at least partially open on the lateral sides. Thus, the openings can enable the molded structure to make a sliding engagement with the fastening fixedly attached to the patient's cranial structure. According to an exemplary arrangement, the molded structure can be shaped to fit the contour of the patient's palate, and the molded structure can include an opening arranged at the intermediate end of the molded structure which is configured to receive the fastening when the molded structure is moved in the intermediate direction when installed in the patient's mouth.

[0044] The molded structure can include one or more molded plates. According to an exemplary arrangement, the molded structure can include a central molded plate and a peripheral molded plate. Each molded plate can be shaped to conform to a respective (i.e., selected) surface of the user's oral cavity, such as a part of the upper jaw and / or the inner surface of the teeth. An inflatable structure such as an airbag can be arranged at the junction between the central molded plate and the peripheral molded plate. The junction between the central molded plate and the peripheral molded plate can define a channel in which the inflatable structure is arranged. The channel can be tapered (i.e., configured such that the width of the channel narrows along the junction between the two molded plates). The tapered channel can narrow from the front to the rear of the molded plate. Thus, the tapered channel can be configured to cause a greater inflation of the inflatable structure in the wider part than in the narrower part. The greater relative inflation of the inflatable structure may cause the molded structures to rotate relative to each other.

[0045] The inflatable structure can be configured to articulate the joint by inflating and / or contracting with hydraulic fluid. The inflatable structure can be contracted, or at least only partially inflated, to facilitate access to the fastening device configured to secure the molded structure to the user's mouth. Additionally or alternatively, the inflatable structure can be inflated to make the joint rigid. Thus, the inflation of the inflatable structure causes the peripheral molded plate to be in close contact with the surface of the user's mouth that it is shaped to conform to. In this way, the peripheral molded plate can be configured to transfer the force generated by the inflatable structure to the user's mouth. Accordingly, the peripheral molded plate can define at least one of the first and second anchors, and the inflatable structure can define at least a portion of the hydraulic pressure transfer structure. By inflating the inflatable structure between the central and peripheral molded plates, the device can be configured to affect the expansion of the upper or lower jaw of the user's oral cavity. The passage of the joint between the central molded plate and the peripheral molded plate can include a substantially straight portion. In use, the straight portion can be arranged at an angle to the midline of the patient's oral cavity. The joint between the molded plates can include a curved portion, the curvature of which can be configured to at least partially follow the curvature of the tongue plane. In the case where the device includes first and second peripheral molded plates arranged on both sides of the central molded plate, the passages between the respective plates can be configured such that they are substantially parallel to each other.

[0046] In the above arrangement, it is recognized that the inflatable structure can be configured to enable relative movement between the central and peripheral molded plate structures. Each inflatable structure can be formed of a flexible material configured to allow relative displacement of the plates in the lateral and / or vertical directions. The enhanced flexibility provided by the inflatable structure means that the peripheral molded plate can be laterally displaced during use and can also rotate relative to the patient's mouth. In this way, the final movement of the peripheral plate causes it to conform to the shape of the patient's mouth, thereby reducing the discomfort of the patient.

[0047] Furthermore, the combination of the above-described inflatable and molded plate structures allows the device to accommodate asymmetrical expansion of the patient's cranial structure. For example, such a device can accommodate the outward rotation of the hemimaxilla caused by greater posterior resistance of adjacent structures. Additionally, it also allows the device to accommodate differences in the relative expansion of the cranial structure (e.g., one hemimaxilla may rotate more than the other), thus ensuring effective force transfer is maintained.

[0048] According to an exemplary embodiment, the first anchor can be defined by a fastening device configured to secure the central molded plate to the user's oral cavity, and the second anchor can be defined by the portion of the peripheral molded plate shaped to conform to the surface of the user's oral cavity. In an alternative embodiment, the molded structure can include another peripheral molded plate arranged on the opposite side of the central molded plate. According to this arrangement, the first and second peripheral molded plates can respectively define the first and second anchors since they can both be configured to transfer opposite forces on opposite sides of the user's oral cavity.

[0049] According to an alternative aspect of the present invention, the inflatable structure may be disposed at the junction between two structural elements. At least one of the structural elements may define an elongate member configured to extend longitudinally from the junction. The other of the two structural elements may be a molded structure configured to conform to the shape of the patient's cranial structure. Alternatively, the first and second structural elements may each include an elongate member. The free end of the elongate member may be attached to the patient's cranial structure. Thus, the free end of the elongate member may define at least one of the first and second anchors as described above. The elongate member may be movably fastened to the other structural element by a bolt fastening device, and the inflatable structure may be received through the central hole of the fastening device.

[0050] In a particularly preferred embodiment, the device includes a molded structure or plate, preferably shaped to conform to the user's mouth. The molded structure may include recesses shaped to conform to the user's teeth. The recesses may be disposed on a surface of the molded structure that is arranged to contact at least one of the inner, outer, buccal, labial, lingual, and occlusal surfaces of the teeth. The molded structure may include a plurality of recesses, each shaped to conform to a plurality of the user's teeth. One or more of the plurality of recesses may preferably include a cantilever structure.

[0051] It is recognized that a recess may accommodate more than one tooth. The recess may include a cantilever structure configured to engage the user's teeth when the device is in place within the user's oral cavity. The surface of the cantilever structure may be shaped to contact the surface of the user's teeth. The cantilever structure may be arranged to contact, face, abut, or engage any surface of the teeth. For example, the cantilever structure may be configured to contact at least one of the inner, outer, buccal, labial, lingual, and occlusal surfaces of the teeth.

[0052] In addition thereto, the device preferably includes a channel or groove, and an inflatable structure received within the channel, the channel being located directly behind the cantilever structure. The channel may be disposed inside the device so as to define an internal channel. The channel may be disposed in the molded structure of the device. The channel is thus preferably curved so as to conform to the curvature of the dental arch. The inflatable structure is preferably arranged such that when it expands, it exerts a force on the cantilever structure that acts to cause the cantilever structure to bend. Thus, in use, when the inflatable structure expands, the force applied to the cantilever structure is applied to the teeth resting within the recesses, and this force acts to cause tooth movement. Thus, the cantilever structure may define a first anchor, and the teeth may define a first anchor point. The second anchor may be defined by a second cantilever structure. Alternatively, the second anchor may be defined by the inflatable structure configured to contact directly the cranial structure, such as a tooth.

[0053] In an exemplary arrangement, the first cantilever structure may be configured to contact a first tooth surface and the second cantilever structure may be configured to contact a second tooth surface. The first and second tooth surfaces may each define an inner or outer surface of the tooth. For example, the first and second cantilever structures may be configured to contact two different surface portions of the tooth. The first and second cantilever structures may be configured to apply separate forces to each of the first and second surface portions of the tooth. The second cantilever structure may be configured to apply a force independently of the first cantilever structure. By configuring the first and second cantilever structures to apply forces independently of each other, the device is operable to achieve greater control over the forces applied by the cantilever structures to the tooth. For example, the first cantilever structure may be configured to apply a first force and the second cantilever structure may be configured to apply a second force, where the first and second forces include different magnitudes and directions. The first and second cantilevers may be configured to apply non-uniform forces on the tooth, causing translation and / or rotation of the tooth.

[0054] The first expandable structure may be configured to apply a force on the first cantilever structure and the second expandable structure may be configured to apply a force on the second cantilever structure. Thus, the expansion of the first and second expandable structures may be controlled to determine the corresponding forces applied by the first and second cantilevers.

[0055] The cantilever structure may define an elongate cantilever finger that includes a first end attached to a molded structure and a second end that is unattached. The unattached end may be movable relative to the molded structure to enable the cantilever finger to bend. It should be appreciated that the cantilever structure may define any structure that includes a fixed end and a movable end (i.e., the movable end is movable relative to the fixed end). The cantilever finger may include a fixed end that is wider than its free end. The cantilever finger may be configured to taper towards the free end.

[0056] The recess may be arranged to be in close contact with the tooth surface, or at a distance from the tooth surface and with a different orientation, such as being angled. Additionally, the recess includes more than one portion. In one embodiment, the first portion may be arranged at a first location on the tooth near the gum line and the second portion may be arranged at a second location substantially away from the gum line. A single cantilever structure may be received within the first and second portions of the recess. The first and second portions of the recess may be interconnected. In some embodiments, there may be more than one cantilever finger. Each of these portions may be naturally molded onto one or more teeth at a slightly or substantially different angle. Alternatively, each portion may be designed such that they are placed at substantially different angles, for example, the cantilever fingers may be individually oriented substantially and act in a plane that is angled upward or downward with respect to a local longitudinal axis (relative to its adjacent portion or the vertical axis) through the airbag.

[0057] The area of each part including the cantilever fingers can vary. For example, compared to thinner fingers, thicker cantilever fingers bend less when a force is applied. The reduced bending of the fingers allows a smaller force to be transmitted to one or more of their paired teeth, so that when a single expandable structure is employed, different finger thicknesses throughout the device will allow different forces to be applied to the teeth. The fingers and / or their adjacent parts can be made of materials of different hardnesses. Additionally, there may be one, multiple, or no fingers in contact with a single tooth or a group of teeth. There can be single or multiple internal channels, the latter accommodating multiple expandable structures.

[0058] The following features may also vary depending on the cantilever structure:

[0059] • The application plane, i.e., the angle of the cantilever structure

[0060] • The area where the force is applied, i.e., the top of the tooth, the middle of the tooth, or along the gum line

[0061] • The length and number of fingers per tooth

[0062] • The hardness of the fingers / different materials

[0063] • Multiple airbags in series or parallel.

[0064] Furthermore, the tunnel / groove / channel can be continuous or discontinuous along the midline. The tunnel shape, perimeter, length, and route can vary. The device can contain multiple tunnels or channels with multiple airbags. The channels can be partially or fully separated to accommodate one or more airbags.

[0065] The internal channels can also vary in multiple ways, such as: route, length, perimeter, continuity, i.e., whether it is connected through a gap between two parts, etc.

[0066] It is also obvious that by changing the characteristics of the above components, a certain tooth or certain teeth can be completely or relatively exempt from force application.

[0067] In an embodiment, the cantilever structure can be defined as an intermediate structure arranged between the expandable structure and the patient's cranial structure. Alternative intermediate structures can include a sliding member or a spoon-shaped member. In the case where the intermediate structure includes a spoon-shaped member, the spoon-shaped member can include a spoon-shaped part that defines a recess of the molding structure, and the recess is shaped to conform to the tooth surface.

[0068] The intermediate structure can be defined by the tooth-facing surface of the recess of the molded structure or a weakened portion of the wall. In this way, the tooth-facing wall of the recess can include an area that is scored or pierced to reduce its rigidity relative to the surrounding recess wall. The weakened surface portion can be defined by two or more cantilever fingers that extend through holes in the recess wall. Each cantilever finger can be connected to another cantilever finger to form a flexible grid arrangement. The grid of cantilever fingers can define a cross-shaped arrangement.

[0069] For example, each of these alternative intermediate structures can be configured to receive a force from the expandable structure and transfer that force to the tooth. In use, when the expandable structure expands and expands outwardly, its outer surface can apply pressure on the inner surface of the intermediate structure, causing the outer surface of the intermediate structure to press against the tooth surface, thereby causing tooth displacement and maxillary expansion.

[0070] It should be appreciated that the intermediate structure can further define any recess or tooth-receiving portion of the molded structure that is configured to be disposed between the expandable structure and the surface of the user's tooth in use and can be configured to transfer a force therebetween. Such an intermediate structure can be necessarily configured to contact any surface of the tooth that can be manipulated to effect tooth displacement. For example, the intermediate structure can be configured to contact at least one of the inner surface, outer surface, and occlusal surface of the user's tooth.

[0071] In the above embodiments, preferably, the first anchor, the second anchor, and at least a portion of the force transfer structure (preferably, the mechanism for converting a periodic force into a first force that is approximately 90° to the periodic force and a second force that is approximately 90° to the periodic force and opposite in direction to the first force or the expandable structure) are sized to fit within the user's oral cavity. Such a device can be referred to as an intraoral appliance because, during use, most of the device is located within the user's oral cavity. This is advantageous because it allows for a more compact device. It should also be accepted that any combination of airbag arrangements within the oral cavity, such as opposite airbags on either side of the teeth that contact a set of teeth, airbags whose expansion causes tooth retraction, and airbags located, for example, above the gums of the maxilla. The same principle also applies to the skull. In embodiments where the device includes a hydraulic force transfer structure, the direction change of the force can be determined by the shape of the expandable structure used.

[0072] In some embodiments, the device can include a molded plate that is shaped to conform to the surface of the user's teeth. In some embodiments, preferably, the molded plate conforms to the surface of the user's teeth in a flush manner to ensure maximum force transfer.

[0073] The molding plate can be shaped to conform to the inner surface of the tooth, the uppermost part of the tooth, and a portion of the outer surface of the tooth. In this way, the tooth is partially enclosed. When a force is applied to the inner surface of the inclined tooth, the outer portion of the molding plate acts as a "rotation stopper", restricting further inclination of the tooth and eventual uprighting. When used on a tooth that is already in the correct plane, i.e., not inclined, the device can effect translation. By minimally increasing the distance between the outer wall of the molding plate and the outer surface of the tooth, the device can accommodate tooth inclination and uprighting, i.e., tooth movement and inclination can occur until the tooth contacts the wall, after which uprighting occurs. At this point, if further expansion is needed, another device can be molded. It should also be understood that one or more recesses can have these features to a lesser or greater extent, or not at all, such as a greater wall height adjacent to the outer surface of the tooth or no cantilever fingers. The reverse arrangement can also be used to "push" the tooth "inward".

[0074] However, in some embodiments, if the molding plate is shaped to conform to the tooth only at the upper part of the tooth, and the spacing distance between the inner surface of the molding plate and the tooth surface increases with the distance from the upper part of the tooth, an additional effect of preventing or correcting tooth inclination can be achieved. Alternatively, the molding plate can be shaped to conform to the tooth only at the lower part of the tooth, and the spacing distance between the inner surface of the molding plate and the tooth surface increases with the distance from the lower part of the tooth. In this way, when the device is used, for example, to effect maxillary expansion, an outward force is applied only after some movement of the upper part of the tooth, e.g., to the lower part of the tooth, e.g., to correct the inclination of the tooth.

[0075] In other words, the molding plate can be shaped to conform to the inner surface, the uppermost (tip) part, and a portion of the outer surface of the tooth. In this way, the tooth is partially enclosed. When a force is applied to the inner surface of the inclined tooth, the outer portion of the molding plate serves as a rotation stopper, restricting further inclination of the tooth and eventual uprighting.

[0076] When used on a tooth that is already in the correct plane, i.e., by restricting or preventing any rotational movement without inclination, the device can effect translation.

[0077] At this point, if further expansion is needed, another device can be molded. It should also be understood that one or more recesses can have these features to a lesser or greater extent, or not at all, such as a greater wall height adjacent to the outer surface of the tooth or no cantilever fingers. The opposite arrangement can also be used to push the tooth towards the middle or inward, i.e., towards the center of the oral cavity. An illustrative drawing related to the geometry of the cantilever structure is shown in Figure 37 is shown.

[0078] In the above embodiments, the skull structure being reconstructed is located between the first and second anchor points. However, the core principle of the present invention is equally applicable to cases where the skull structure to be altered is not located between two anchor points. Accordingly, a second aspect of the present invention provides an apparatus for reconstructing the skull by expansion, compression, or bending of a skull structure having a first anchor point, the apparatus comprising: a head support having a head receiving portion configured to receive a portion of a user's head; a force generator configured to generate a periodic force; a first anchor for attachment to the first anchor point; a force transmission structure connected to the force generator and configured to transmit the periodic force in a reconstruction direction to the first anchor; wherein the head support includes: a restraint device configured to, in use, prevent or limit movement of the user's head in the reconstruction direction when the periodic force is applied. In a very simple arrangement, the second aspect of the present invention can be implemented by an arrangement in which the force generator is connected via a force transmission structure to one or more bone screws that are located, for example, in the side wall of the maxilla via one or more wires and an oscillating force is applied. In this case, as discussed in more detail below, the restraint device can be in the form of a friction-providing device or simply the weight of the user's head that prevents the head from oscillating due to its inertial mass. A fixing strap can also be used to stabilize the head.

[0079] Where compatible, the optional features described above with reference to the first aspect of the present invention can be equally well applied to the second aspect of the present invention and, for the sake of brevity, are not repeated here. In these embodiments, the head support includes a restraint device that prevents the periodic force from causing only displacement of the entire user's head or the apparatus. In other words, the restraint device receives at least a component of the reaction to the periodic force. Examples of the restraint device will be discussed in more detail later. The apparatus of the second aspect of the present invention is particularly useful for maxillary protraction.

[0080] The apparatus can take the form of a bracket device including a head support and a track. The head support is preferably configured to tighten around the user's head, preferably in a manner such that the force is applied to the side surfaces of the user's head and face. This means that when a front-to-back force is applied, the friction between the user's head and the inner surface of the head support serves to prevent the user's head from moving back and forth. When a lateral force is applied, the rigidity of the structure and its fixing mechanism also contribute to resisting lateral movement. In other words, in such an embodiment, the inner surface of the side of the head is supported by at least a portion of the restraint device. More generally, it can be said that the restraint device is configured to limit or prevent movement of the user's head by friction. For effectiveness, the frictional force generated by the contact between the user's head and the inner surface of the head support should be greater than the periodic force applied to the first anchor point.

[0081] Alternatively, the restricting device may include an abutment surface configured to abut the user's head in use, wherein contact with the abutment surface is configured to prevent or restrict movement of the user's head in the reconfiguration direction. In some embodiments, the weight of the user's head may alone provide the restricting device.

[0082] The track is preferably connected to the head support by one or more connectors. In such an embodiment, the force generator may be in the form of a motor connected to the head support and the proximal end of the connector. Alternatively, the force generator may be in the form of a hydraulic pump, also connected to the proximal end of the connector. In some embodiments, there may be a first force generator and a second force generator, connected to the track via a first connector and a second connector respectively. The track is preferably attached to the distal end of one or more connectors. The track and the first and / or second connectors may form part of a force transmission structure, which may further include one or more additional connectors, such as a third connector, whose proximal end is preferably attached to the track and whose distal end includes a first anchor, as discussed previously in this application, the first anchor being configured for attachment to a first anchor point. The first anchor point may be in the form of a tooth, the maxilla, the mandible, a part of the occlusal surface, the zygomatic bone, the upper part of the skull, the nose or other structures.

[0083] For symmetric protrusion, the device preferably includes a second anchor for connection to a second anchor point of the cranial structure. The device may also include a fourth connector, which includes the second anchor at its distal end. The second anchor point may be any of the same cranial structures listed for the first anchor point in the previous paragraph.

[0084] In some embodiments, the device may include multiple tracks, such that protrusion of more than one cranial structure may be achieved simultaneously. There is preferably at least one and preferably a pair of force generators, each associated with one of the multiple tracks, connected to the track via a connector.

[0085] In some embodiments, the height of the track may be varied. By "height" is meant the extent in the up-down direction. In this way, a single device may be used to effect reconfiguration of different cranial structures without having to use a completely different device. To achieve this, one or more connectors may be rotatably attached to the head support such that the assembly including the one or more connectors and the track may be rotated to a desired position for cranial reconfiguration. Alternatively, the assembly including at least the connector and the track, preferably also including one or more force generators, may be translated in the up-down direction, for example on a dedicated structure. In some embodiments, the track may be mounted on an assembly on which the track may rotate and translate to allow greater flexibility of movement.

[0086] In some embodiments, the restricting device may be located on the track. Preferably, the restricting device may be movable along the track such that it can be located at the optimal position for a particular skull reconstruction being performed. There may be multiple restricting devices, for example to ensure symmetric operation.

[0087] The present invention also encompasses devices that can be used for skull compression. While embodiments of some aspects of the present invention set forth above can be used to perform compression, most of them are directed to systems that apply tension to the skull structure. A third aspect of the present invention provides a device for skull compression, comprising: a head support unit configured to apply a compressive force on at least a portion of a user's skull; a force generator configured to generate a periodic force; and a force transmission structure configured to transmit the periodic force to the user's skull.

[0088] In some embodiments of the third aspect of the present invention, the head support includes or is in the form of a helmet, and the inner surface of the helmet is shaped or molded to conform to the outer surface of the user's head. By molding the helmet to closely conform to the shape of the user's head, it is possible to ensure a tight fit, which will apply pressure substantially equally in all directions on the user's skull during use. Areas may be omitted to restrict the application of force to a particular region of the head. Embodiments of the third aspect of the present invention may be used to correct specific skull deformities, which will require the application of compressive force in a specific direction on a specific part of the user's skull. Benefits can also be obtained by the action on the soft tissue structure. Thus, very preferably, the head support includes a first part positioned to cover the skull structure in question, and a second part positioned opposite or substantially opposite the skull structure in question. Here, "opposite" should be understood to mean that in use, the first part and the second part are located on opposite sides of the user's skull. This ensures that when a compressive force is applied by the first part to the skull structure under discussion, the second part can provide the required reaction force to maximize the effect of the compressive force.

[0089] In some embodiments, rather than the head support being in the form of a molded helmet, the head support may include a first part and a second part movable relative to each other, and means for connecting the first part to the second part in such a way that the inner surfaces of the first part and the second part are configured to apply a compressive force on the user's skull. In some embodiments, the first part and the second part may be connected to each other at a hinge. Then, the first part and / or the second part may include locking means for fixing the first part and the second part in a region opposite the hinge. For example, the first part may be shaped to receive the back of the user's head such that the user can lie face up in the first part. The hinge may be located in a region corresponding to the top of the user's head such that once the user places their head in the appropriate position in the first part, the second part can be lowered (i.e., pivoted about the hinge) above their head and connected to the second part by a suitable locking means.

[0090] In other embodiments, the head support may further include a third portion, and the second and third portions are connected to the first portion by hinges. Similar to the embodiments described in the previous section, the first portion may be shaped to receive the back of the user's head such that the user can lie face up in the first portion. The hinges may be located in regions corresponding to the left and right sides of the user's head such that once the user places their head in the appropriate position in the first portion, the second and third portions can rise around the sides of the user's head and be fixed to each other by suitable locking means. This can be used, for example, for the lateral compression of the user's skull. These embodiments can also easily incorporate hydraulic elements to actuate other components and directly apply force to the anchor points, such as by including an expandable structure on the surface of the structure that contacts the skull.

[0091] Similar to the force transmission structure of the foregoing aspect of the present invention, the force transmission structure of the third aspect of the present invention is preferably a hydraulic force transmission structure. It preferably includes one or more expandable structures, such as airbags or bellows, which are located on the inner surface of the head support at positions corresponding to the skull structures under discussion. The force generator is preferably configured to periodically expand and contract the expandable structures in order to superimpose a periodic force on the static compression force applied by the head support.

[0092] The first three aspects of the present invention focus on the periodicity of the force. However, the inventors have noted that an apparatus capable of applying any force (such as a constant force, a continuous force, a decaying force, or a periodic force as defined earlier in this application) by using a hydraulic force transmission structure can provide advantageous effects. Using a hydraulic force transmission structure results in a more efficient and easier-to-control transmission of force from the force generator to the skull structure. The following aspects of the present invention focus on an apparatus for transmitting a general force using a hydraulic force transmission structure, whether the force is constant or otherwise. It should also be understood that all aspects, including electromechanical variants, can be used to generate a constant force as well as a continuous displacement rate, i.e., a constant rate.

[0093] Accordingly, a fourth aspect of the present invention provides an apparatus for cranial remodeling by expansion, compression, or bending of a cranial structure located between a first anchor point and a second anchor point, the apparatus comprising:

[0094] A force generator configured to generate a force;

[0095] A first anchor for attachment to the first anchor point;

[0096] A second anchor for attachment to the second anchor point;

[0097] A hydraulic force transmission structure that is connected to the force generator and is configured to transmit a periodic force to the first anchor and the second anchor, thereby placing the cranial structure in at least one of tension, compression, or bending.

[0098] A fifth aspect of the present invention provides an apparatus for cranial reconstruction by expansion, compression or bending of a cranial structure having a first anchor point, the apparatus comprising: a head support having a head receiving portion configured to receive a portion of a user's head; a force generator configured to generate a force; a first anchor for attachment to the first anchor point; a hydraulic force transmission structure connected to the force generator and configured to transmit a periodic force in a reconstruction direction to the first anchor; wherein the head support comprises: a restraint device configured to prevent or limit movement of the user's head in the reconstruction direction during use when a periodic force is applied.

[0099] A sixth aspect of the present invention provides an apparatus for cranial compression, comprising: a head support unit configured to apply a compressive force to at least a portion of a user's skull; a force generator configured to generate a force; and a hydraulic force transmission structure configured to transmit a periodic force to the user's skull.

[0100] Those skilled in the art will appreciate that the optional features described above for the first, second and third aspects of the present invention can also be applied to the fourth, fifth and sixth aspects of the present invention. In particular, the skilled person will note that the optional features of the first aspect of the present invention are particularly (but not exclusively) applicable to the fourth aspect of the present invention, the optional features of the second aspect of the present invention are particularly (but not exclusively) applicable to the fifth aspect of the present invention, and the optional features of the third aspect of the present invention are particularly (but not exclusively) applicable to the sixth aspect of the present invention.

[0101] The apparatus according to the present invention can be made entirely of MRI-safe materials, such as polymers and / or non-magnetic materials. In this way, a user undergoing an MRI scan can use the apparatus.

[0102] It should be noted that in some cases, more than one apparatus according to any embodiment of any aspect of the present invention can be used in combination with each other to provide cranial reconstruction. For example, stretching of the maxilla using an embodiment of either the first or fourth aspect of the present invention can be performed in the same procedure as cranial compression. The apparatus of the present invention is preferably programmable to work synchronously and / or simultaneously. BRIEF DESCRIPTION OF THE DRAWINGS

[0103] The present invention will now be described with reference to the accompanying drawings, in which:

[0104] - Figure 1A and 1B shows an example of an apparatus for maxillary expansion.

[0105] - Figure 2A and 2BShows an example of an alternative device for maxillary expansion.

[0106] - Figure 3 Shows an example of another alternative device for maxillary expansion.

[0107] - Figure 4 Shows an example of another alternative device for maxillary expansion.

[0108] - Figure 5 Shows an example of a similar device for mandibular expansion.

[0109] - Figure 6A and Figure 6B Shows an example of an alternative device for maxillary expansion.

[0110] - Figure 7A 、 7B and 7C show examples of alternative devices for maxillary expansion.

[0111] - Figure 8A and 8B Show an alternative device for maxillary expansion.

[0112] - Figure 8C Shows various options for the various components of the maxillary expansion device.

[0113] - Figure 9 Shows an example of a device for anterior maxillary expansion.

[0114] - Figure 10 Shows an example of a device for anterior maxillary expansion.

[0115] - Figure 11 Shows an example of a device for maxillary expansion, including two molded plates and multiple airbags.

[0116] - Figure 12A and 12B Show alternative devices for maxillary expansion using multiple airbags.

[0117] - Figure 12C and 12D Show an alternative device for maxillary expansion, including a recess containing cantilever fingers and an elongate airbag.

[0118] - Figures 12E to 12H Shows four further examples of devices for reconstructing the occlusal surface.

[0119] - Figure 12I Shows a close-up of a depression that can be found in a device such as Figures 12F to 12H for example.

[0120] -Figure 12J and 12K respectively show cross-sections of alternative devices for maxillary expansion, including an inflatable structure and a sliding member.

[0121] - Figure 12L shows a cross-section of an alternative device for maxillary expansion, including an inflatable structure and a spoon-shaped member.

[0122] - Figure 13A shows an example of a device that can be used to achieve maxillary expansion.

[0123] - Figure 13B shows an airbag that can be used with the device of Figure 13A .

[0124] - Figure 14A shows a device that can be used to separate the skull.

[0125] - Figure 14B shows a close-up view of the expansion mechanism that can be used in various embodiments of the present invention.

[0126] - Figure 15A and 15B show views of alternative expansion mechanisms that can be used in various embodiments of the present invention.

[0127] - Figures 15C to 15E shows a slotted screw hole arrangement.

[0128] - Figures 16A to 16D shows an example of a device that can be used for maxillary expansion and minimize or reverse the effect of tooth tipping.

[0129] - Figures 17A to 17C shows various ways of installing the device according to the present invention onto a user's body.

[0130] - Figure 18 shows an example of a device that can be used for maxillary protraction.

[0131] - Figure 19 shows an example of a crossbar structure that can be used in the device of Figure 18 .

[0132] - Figure 20A and 20B show alternative crossbar structures that can be used in the device of Figure 18 .

[0133] - Figure 21 shows an example of an alternative device that can be used for maxillary protraction.

[0134] - Figure 22A shows a device that can be used as in Figure 21Example of the hydraulic crossbar structure of the device shown.

[0135] - Figure 22B and 22C shows Figure 22A a close-up view of the components in the crossbar structure.

[0136] - Figure 23 shows an alternative device that can be used for maxillary protraction, with two horizontal attachment points on the skull.

[0137] - Figure 24 shows an alternative device that can be used for maxillary protraction.

[0138] - Figures 25A to 25C shows a schematic diagram of a device for transmitting force to the zygomatic bone.

[0139] - Figures 25D to 25F is a schematic diagram showing the device placed between the zygomatic bone and the maxilla.

[0140] - Figure 26 shows an alternative device that can be used for maxillary protraction.

[0141] - Figure 27A and 27B shows an adjustable device, where the attachment point is the nasal bone.

[0142] - Figure 28 shows an adjustable device, where the attachment point is the intranasal structure.

[0143] - Figures 29A to 32B shows an arrangement including multiple tracks that can be used for various types of skull reconstruction.

[0144] - Figure 33A and 33B shows a helmet device that can be used for skull compression.

[0145] - Figures 34A to 34E shows an example of an arrangement where a user can place their head to receive compression or other types of skull reconstruction from an external device.

[0146] - Figure 35 shows an alternative device that can be used for skull compression in the up and down direction.

[0147] - Figure 36A and 36B is a schematic diagram illustrating how to use Figure 35 the device.

[0148] - Figure 37 shows multiple different geometries of the cantilever fingers in the recess.

[0149] - Figure 38A and 38B shows a Matthews - Tesz traction device that can be used in conjunction with embodiments of the present invention. Detailed Description

[0150] Figure 1A and 1B shows Embodiment 100 of the device of the present invention, which can be used to widen the maxilla 102 (shown inverted in these figures), but can equally well be used to widen the mandible. The device includes an extra - oral force generator 104 connected to an intra - oral portion 106 by a linkage 108. The force generator 104 can include a motor (not shown). The intra - oral portion 106 includes a central portion 110 having two threads 112, 114 and a central ball - and - socket 116. The distal end 108d of the linkage 108 includes a screwdriver portion 109 configured to rotate the central ball - and - socket 116. The intra - oral portion 106 also includes two pairs of laterally extending arms 118a, 118b and 120a (and another arm not visible in the figure). The arms 118a, 118b are respectively connected to first and second rings 122a, 122b, which themselves firmly surround teeth 124a, 124b. Similarly, the non - visible arm 120a and the second arm are respectively connected to third and fourth rings 126a, 126b, which firmly surround teeth 128a, 128b. In operation, the oscillatory rotation of the motor within the extra - oral force generator 104 causes the distal end 108d of the linkage 108 to rotate, such that the screwdriver portion 109 causes the central ball - and - socket 116 to rotate in an oscillatory manner. This oscillatory motion in turn produces lateral forces on the threads 112, 114, which are transmitted into the laterally extending arms 118a, 118b, 120a and the non - visible second arm, and the rings 122a, 122b, 126a, 126b apply periodic lateral outward forces on the teeth 124a, 124b, 128a, 128b. This lateral outward force can displace the teeth and / or widen the maxilla. Figure 2A and 2B The device 500 shown is substantially the same as Figure 1A and 1B the device 100 shown, except that there are two rods 508, 511 allowing independent force transmission to teeth 524a, 524b and 528a, 528b. Reference numerals similar to those used in Figure 1A and 1B denote Figure 2A and 2BSimilar features. As a result of continuous rotation rather than oscillatory rotation, useful effects can also be obtained. For example, the device can rotate 90 degrees in 12 hours. The rotation rate may be variable. The device can also be used to generate an inward force and slightly rearrange the central mechanism (e.g., reverse the direction of the threads 112, 114 or reverse the actuation direction). Such rearrangement is entirely within the purview of a person skilled in the art.

[0151] Figure 3 An alternative embodiment 200 is shown, in which the periodic force is hydraulically transmitted. The device 200 includes two tubes 202, 204, each tube being connected to an intraoral portion 206. As Figure 1A and 1B shown, the intraoral portion 206 includes two pairs of laterally extending arms 208a, 208b, 210a, 210b. The arms 208a, 208b are respectively connected to the first and second rings 212a, 212b, and the first and second rings 212a, 212b themselves firmly surround the teeth 214a, 214b. Similarly, the arms 210a, 210b are respectively connected to the third and fourth rings 216a, 216b, which firmly surround the teeth 218a, 218b. Although Figure 3 not shown in , the tubes 202, 204 are connected at their proximal ends 202p, 204p to a force generator, which may include a pump. Specifically, the tubes 202, 204 may contain a hydraulic fluid such that the action of the pump causes the fluid to move back and forth within the tubes 202, 204. In some embodiments, the pump may be a manual pump with an indicator (visual, auditory, tactile, or a combination thereof) to notify the user when to pump. An adjustable pressure regulator may also be used to regulate the pressure generated by irregular user activity. However, in a preferred embodiment, the pump is automatic, preferably an electric pump or an electromechanical pump. The fluid movement within the tubes 202, 204 is converted into a laterally outward force on the laterally extending arms 208a, 208b, 210a, 210b and the rings 212a, 212b, 216a, 216b to apply a periodic laterally outward force on the teeth 214a, 214b, 218a, 218b. Such a laterally outward force can displace the teeth or widen the maxilla. Figure 4 A device 300 is shown that is substantially the same as the device 200 in FIG. 2, except that in this case, the device 300 is not anchored to the teeth but is mounted on the bone of the oral cavity roof through the soft tissue covering the oral cavity roof. In an alternative embodiment, the device can also be anchored to the walls of the oral cavity and / or teeth.

[0152] Figure 5 is shown to be similar to Figure 1A and 1BThe device shown, except that it is shown here as being located on the mandible rather than the maxilla. The internal channels can, for example, pass through the midline in the form of a flexible connection, or each part can have its own internal channel. Those skilled in the art will understand that Figure 1A and 1B the description of which applies equally well here. Additionally, it can be understood that Figures 2A to 4 the device of which can also be directly modified for use on the mandible rather than the maxilla.

[0153] Figure 6A An intraoral device 600 (shown inverted) for expanding a user's dental arch is shown. The device 600 includes a plate 602 that is shaped to conform to the user's palate. The molded plate 602 includes a plurality of recesses 604 around its perimeter, each recess 604 being shaped to conform to the surface of a corresponding tooth. In Figure 6A the device 600, there is also an optional structure 606 that is shaped to wrap around the outer surface of the tooth. Each part of the device arranged to contact the user's teeth includes an airbag through which force can be transmitted to the tooth through holes in the recesses between the airbag and the tooth surface. Specifically, the force transmitter in this example is hydraulic. In Figure 6A , an additional part for anchoring to the user's teeth is provided. Figure 6B the device 600' is similar to Figure 6A the device 600, with like reference numerals representing like features. In Figure 6B , the device 600' also includes two holes 608' that are positioned to receive screws 610' fixed to the user's palate. The device 600' also includes slots 612' that are shaped to accommodate screws (not shown) in the user's palate wall. Those skilled in the art will understand that Figure 6A and Figure 6B the embodiments of which can be combined, and all the features shown are optional.

[0154] Figure 7A , 7B , 7C and 8A show additional examples of devices 700, 750, 760, 800, each device including molded plates 702a and b, 752a and b, 762a and b, 802a and b. The expansion mechanisms 704, 754, 764, 804 of each device are as shown and described in detail with reference to Figure 8B (see below). Figure 7A , 7B , 7C and 8A differ in the areas where they apply force in the oral cavity:

[0155] - In Figure 7AIn the device 700, force is applied through two plates 702a, 702b which are molded to conform to the inner surface of the palate. This ensures uniform distribution of the force across the palate and thus ensures uniform expansion.

[0156] - In Figure 7B the device 750, there are two molded plates 752a, 752b. Figure 7B The device 750 of Figure 7A differs from the device 700 of Figure 7B in that one of the molded plates 702a is replaced by a molded plate 752a which is shaped to conform to the inner edge of the teeth in addition to conforming to the inner surface of the palate. This means that force is applied to the inner surface of the palate and the teeth. In some embodiments, the molded plate may also include a portion shaped to conform to the inner surface of the teeth near the gum line. Such a molded plate is not specific to

[0157] - In Figure 7C the device 760, there are two molded plates 762a, 762b. Figure 7C The device 760 of Figure 7A differs from the device 700 of

[0158] - In Figure 8A the device 800, there is only a single molded plate 802b. The other molded plate is completely replaced by a wire structure 806 where the wire 802a is shaped to conform to the inner surface of the teeth and does not directly contact the inner surface of the palate. In the illustrated embodiment, the wire contacts three teeth, but those skilled in the art will understand that embodiments of the present invention need not be limited to contacting three teeth; other numbers of teeth, such as one, two, four, five or six, can be envisioned.

[0159] Figure 8B is shown for use in Figures 7A to 8AClose-up view of the central mechanism of the device shown. In this embodiment, the screw provides a static "background" force that can be modified externally by tightening or loosening through a hole in the upper surface of the screw head. In use, the hydraulic component provides an additional periodic force that effectively superimposes on the static force to produce a periodic non-zero force. In the embodiment shown, one side of the jaw represents the first anchor point, the oral portion against which the other component abuts represents the second anchor point, and the resulting force puts the jaw between these regions in tension. To some extent, the dental arch is also in flexion, which also serves to widen the jaw. Figure 8C Various examples demonstrating the modularity of the present invention are shown.

[0160] Figure 9 and Figure 10 The embodiment shown is somewhat similar to Figures 7A to 8A the embodiment shown, except that the device is oriented in the anteroposterior direction on the palate to effect expansion of the anterior maxilla. In Figure 9 and 10 the configuration shown, the central mechanism is fixed to the upper surface of the oral cavity (the maxilla is shown inverted) by, for example, bone screws, although other fasteners are equally applicable. The mechanism can be the same as or substantially the same as Figure 8B the mechanism shown, with the background static force being produced by the screw and the additional periodic component being hydraulically applied. In Figure 9 and Figure 10 , the portion of the palate to which the bone screw is attached forms, for example, the first anchor point and the bone screw forms the first anchor. The second anchor is different from Figure 9 and Figure 10 , although in both cases, a molded plate is used:

[0161] - In Figure 9 , the second anchor is in the form of a molded plate, the front edge of which is shaped to conform to the posterior side of the front teeth. A portion of the molded plate is also shaped to conform to the surface of the palate. This ensures that the force is evenly transmitted to the teeth and the jaw to effect uniform maxillary expansion.

[0162] - In Figure 10 , the molded plate does not contact the teeth but only contacts the soft tissue of the upper palate, and the bone screw can be located in this soft tissue (not shown).

[0163] In Figure 9 and 10 the embodiments shown, it will be apparent to those skilled in the art that the lateral extent of the molded plate can vary and the front edge can contact, for example, a number of teeth other than four, such as one, two, three, five, or six.

[0164] Figures 11 to 12BAn embodiment of the present invention is shown which includes a single molded plate having a central slot containing a central expansion mechanism, each being shaped to conform to the palate, with the central expansion mechanism located therebetween. Alternatively, a similar effect can be achieved using two separate plates. The outer edge of the molded plate includes a series of recesses, the positions of which correspond to the positions of the user's teeth. The device also includes a series of airbags configured to fit between the recesses and the user's teeth such that inflation of the airbags causes pressure to be applied to the user's teeth.

[0165] Figure 12C and 12D An embodiment of the present invention is shown which includes a single molded plate having a central slot containing a central expansion mechanism, each being shaped to conform to the palate, with the central expansion mechanism located therebetween. Alternatively, a similar effect can be achieved using two separate plates. The outer edge of the molded plate includes a series of recesses, the positions of which correspond to the positions of the user's teeth. The device also includes a groove or channel in which an elongate inflatable structure is received, the outer surface of the inflatable structure being in contact with the inner surface of a cantilever structure in the form of cantilever fingers.

[0166] The cantilever structure is arranged such that its outer surface is substantially aligned with the tooth-facing surface of the recess of the molded structure. In use, when the inflatable structure inflates and expands outwards, its outer surface applies pressure on the inner surface of the cantilever structure, causing the tooth-facing surface of the cantilever structure to press against the tooth surface, thereby causing tooth displacement, and when multiple teeth move, the dental arch expands (i.e., maxillary expansion). In this way, the inflatable structure is configured to push the cantilever structure between an unbiased configuration (i.e., the cantilever is received within the molded structure) and a biased configuration, in which the cantilever structure extends forward from the tooth-facing surface of the recess. Thus, the cantilever structure defines an intermediate structure disposed between the inflatable structure and the teeth.

[0167] In an alternative arrangement, the cantilever structure can be arranged to project from the tooth-facing surface of the recess even when the inflatable structure is not applying a force. Thus, when the molded plate is installed in the patient's mouth (such that the tooth-facing surface of the recess is in contact with the teeth), the corresponding teeth apply a force on the outer surface of the cantilever structure, thereby biasing it towards the inflatable structure. The inflatable structure can be configured to resist the resultant force applied on it by the cantilever structure.

[0168] In Figures 11 to 12DIn the illustrated embodiment, the expandable structure may include a plurality of air bladders that are in fluid communication with each other (which is advantageous as they can all be inflated from a single source), but alternatively, other embodiments may include a plurality of air bladder bands. The air bladders may be independently inflatable to provide a greater degree of control. A static (i.e., "background") force can then be applied by adjusting a screw in the central mechanism, thereby applying a constant external force to the inner surface of the teeth through the air bladders. Then, in use, the air bladders can be periodically inflated / deflated to provide a periodic component that is superimposed on the static component provided by the molding plate, thereby applying a non - zero force that is always positive to the teeth to effect maxillary expansion. Alternatively, the non - zero force can be generated by air bladder expansion and further pulsations impart the periodic component. Note that in Figures 11 to 12B the illustrated embodiment, the air bladders are shown only on one side of the device, but it will be apparent to those skilled in the art that the air bladders can be positioned on both sides. For example, there can be a single molding plate and the opposite sides of the central mechanism can be fixed to the palate along lines such as Figure 9 and 10 . Alternatively, as Figures 7A to 8A illustrates, a molding plate having an expandable structure on one side can be combined with an alternative anchoring structure on the other side, such as being directly molded to the teeth, or a wire structure. It should be noted that throughout this application, it is contemplated that a first anchor of one embodiment can be combined with a second anchor of another component, if compatible.

[0169] Figures 12E to 12G An embodiment is shown that is designed to facilitate remodeling through action at the occlusal plane, which can be defined as an imaginary plane between the upper and lower dental arches. Figures 12E to 12G The device of includes a continuous U - shaped air bladder connected to a hydraulic line that the user bites down on during use. Then, the periodic inflation / deflation of the air bladder generates a force applied to the user's teeth. A feedback system can be used to indicate how tightly the user should bite. In Figure 12F , an inflatable occlusal plate is mounted to a portion molded to conform to the teeth of the lower dental arch. It should be understood that the reverse or other arrangements are possible. In Figure 12GThere are multiple airbags and multiple hydraulic tubes. Each airbag is arranged to contact a single tooth or a series / group of teeth, and each hydraulic tube is operably connected to a corresponding one of the multiple airbags. The airbags are arranged to conveniently leave the device, where the tubes are contained within the device and exit from the front of the device. According to an exemplary alternative arrangement, the airbags are arranged within a guiding element configured to prevent the airbags from opening or expanding in the lateral direction when compressed between a tooth and a bite plate. The guiding element includes a groove or channel having rigid sidewalls. The channel has an open bottom surface such that, in use, the airbag can directly contact the occlusal surface of the tooth. In this way, the rigid walls ensure that the airbag expands in a substantially vertical direction, thereby increasing the force applied to the tooth. Similarly, other arrangements are possible.

[0170] In Figure 12H and 12I therein, cantilever fingers are arranged along the occlusal surface at the bottom of a recess. The recess is molded into part or all of the dental crown. When the expandable structure beneath the fingers expands, the cantilever fingers shift upward or shift at an upward angle, i.e., upward but can be inclined. This action provides force to the uppermost path of the tooth and the alveolar bone.

[0171] Figure 12J and 12K shows a cross-section of an alternative device for maxillary expansion, including an expandable structure and a sliding member. The sliding member defines an intermediate structure arranged between the expandable structure and the tooth.

[0172] The sliding member is accommodated within the molded structure of the device in a manner similar to the above-described cantilever structure. The device includes a groove or channel in which an elongate expandable structure is accommodated, and the outer surface of the expandable structure is arranged to contact the inner surface of the sliding member. The elongate sliding member is accommodated within a corresponding channel that extends in a direction substantially perpendicular to the longitudinal direction of the elongate expandable structure. In use, when the expandable structure expands and expands outwardly, its outer surface applies pressure on the inner surface of the sliding member, causing it to press against the tooth surface, thereby causing the tooth to shift, and when multiple teeth move - the dental arch expands (i.e., maxillary expansion). The sliding member is shown in Figure 12J in an unbiased configuration (i.e., the received position within the molded structure), and in Figure 12K is shown in a biased position where the sliding member protrudes from the tooth-facing wall of the recess.

[0173] The sliding member includes a locking portion that is wider than the rest of the sliding member. The locking portion is accommodated within a corresponding portion of the channel and is configured to limit the travel of the sliding member along the channel. A spring is arranged between the locking portion of the sliding member and the inner wall of the channel locking portion. The spring is configured to prevent the sliding member from protruding from its channel. As Figure 12J and 12KAs shown, when viewed in a longitudinal cross-section, the locking portion of the sliding member may include a substantially square profile. Alternatively, when viewed in the same longitudinal cross-section, the locking portion may include a triangular or frustoconical profile. Thus, the locking portion may taper as it extends away from the outer peripheral surface of the sliding member.

[0174] Figure 12L A cross-section of an alternative device for maxillary expansion is shown, including an expandable structure and a spoon-shaped member. The spoon-shaped member defines an intermediate structure disposed between the expandable structure and the teeth. The spoon-shaped member includes a spoon-shaped or hook-shaped portion that, when in use, is arranged to wrap around the patient's teeth or dental implants. In use, the spoon-shaped member is actuated in a manner similar to the cantilever member and / or the sliding member described above. In particular, expansion of the expandable structure causes the spoon-shaped portion to apply a force on the teeth, resulting in maxillary expansion. The spoon-shaped portion may be configured such that it covers different portions of the labial and lingual surfaces of the teeth. The spoon-shaped portion may be configured such that it does not cover or contact the occlusal surface of the teeth.

[0175] In any of the above embodiments, the tooth-facing surface of the device may be configured to grip the teeth it contacts. Specifically, at least one of the molded structure, the recess, and the intermediate structure may be configured with a tooth gripping portion or a tooth gripper. The tooth gripping portion may include circular or pointed nodules protruding from the tooth-facing surface.

[0176] Figure 13A and 13B relates to a component where a central molded plate may be fixed to the top of the user's oral cavity, for example, using bone screws or other suitable fasteners. In addition to the central molded plate, there are three additional peripheral molded plates, each shaped to conform to a corresponding surface of the user's oral cavity, such as a portion of the jaw and / or the inner surface of the teeth. The three peripheral molded plates are connected to the central molded plate by airbags, an example of which is Figure 13B shown. The airbags are located between the central molded plate and the peripheral molded plates in such a way that when the airbags contract or are only partially inflated with hydraulic fluid, i.e., the joints are hinged to facilitate access to the anchor screws. But when the airbags expand, the joints become more rigid and cause each corresponding peripheral plate to come into close contact with the portion of the mouth it is molded to. The movement of the airbags in the tunnels or between the central and peripheral molded plates transmits the force to their respective contact points.

[0177] In this way, the airbags may be configured to directly contact the molded plate structure. An alignment mechanism may be arranged at the junctions between the molded plate structures. The alignment mechanism may be configured to maintain the alignment of the molded plates when the molded plates are separated from each other due to the expansion of the airbags. The alignment mechanism may include at least one alignment rod arranged to extend through a channel between the molded plate structures.

[0178] The present invention is not limited to devices for oral applications. Figure 14A and 14B shows an application of the device 1000 according to an embodiment of the present invention, which is used to traction cranial sutures. Many devices can be arranged along one or more sutures. Figure 14A and 14B shows an exemplary embodiment of a device suitable for this application. Figure 14A shows Figure 14B the proper position of the device on the user's skull. The device 1000 is actually the same as the devices of Figure 15A and 15B , so for the sake of brevity, the detailed description will not be repeated here. The devices in FIGS. 14 and 15 differ from each other only in that in Figure 14A and 14B , the screws have flat hexagonal heads, while in Figure 15A and 15B , the screws have dome-shaped heads. The operation of the devices is the same. Any embodiment using screw fixation can use shaped screws, such as dome-shaped screws, in combination with "slotted" screw holes, which allows for easy replacement of the device without disturbing the permanent fixation, i.e., in the example of a given screw.

[0179] Figure 15A and 15B show, respectively, an undissected and dissected example of the component 1500, which can be used as a central expansion mechanism in various embodiments of the present invention. The mechanism 1500 is substantially symmetric, so for the sake of brevity, we will only describe the right hand side here. The mechanism 1500 includes the following main components, each of which will be described in more detail in turn: a central component 1520, a hydraulic component 1540, a channel component 1560, and an attachment component 1580.

[0180] The central component 1520 includes two elongated cylindrical rods 1522a, 1522b, each having a longitudinal axis extending in the left-right direction. There is a central threaded component 1524 between the rods 1522a, 1522b, which has threaded portions 1525a, 1525b at each end, with opposite directions. The central region of the threaded component 1524 has no threads. There is a component 1526 at the center of the central component 1520. As Figure 15A best shown, each rod 1522a, 1522b has a small notch 1528 at the center, and the central component 1526 rests in this notch. The proximal unthreaded portion of the threaded component 1524 is integral with the component 1526. There is a hollow hole 1530 on the top surface of the component 1526. A pin can be inserted into the hole 1530 to rotate the threaded component 1524 around its longitudinal axis.

[0181] The hydraulic component 1540 is relatively simple. It includes an airbag portion 1542 which is a slender generally cylindrical airbag 1544 having a conical or frustoconical tip 1546 at its distal end. The proximal end of the airbag 1544 is connected to a tube 1548 which is connected at its proximal end to a hydraulic pump (not shown). The channel member 1560 is preferably a single-piece material which includes on its outer surface a recess forming a channel 1564 which is shaped to receive the airbag 1544 such that its outer surface is flush with the inner surface of the channel 1564. In a preferred embodiment, when the airbag 1544 is in place within the channel 1564, the outer edge of the airbag 1544 is aligned with or extends through the outer wall of the member. The channel member 1560 also has two holes 1566, 1568 formed therethrough, each shaped to receive one end of the rods 1522a, 1522b of the central member 1520. There is also a recess between the two holes 1566, 1568 which has a hole 1572 at its center which is configured to receive the threaded end of the threaded member 1524.

[0182] The static force applied by the threaded member 1524 is applied through internal threads on the central hole of the channel member which are configured to engage the external threads on the threaded member 1524.

[0183] The attachment member 1580 is also preferably formed of a single-piece material and includes three holes 1582, 1584, 1586 which are aligned with the holes 1566, 1568, 1572 on the channel member 1560 and are configured to receive the rods 1522a, 1522b and the threaded end of the threaded member 1524 when they protrude from the outer surface of the channel member 1560. Integrally formed with the body 1581 of the attachment member 1580 are wings 1583, 1585 each of which extends horizontally from the base 1586 of the body 1581 and includes holes 1588, 1590 which are configured to receive respective screws 1592, 1594. It is generally preferred that one or more fixation pins are permanently fixed to the skull by bone threads. The device to be attached to the fixation pins has specially formed positions and locking slots to match the pins. The fixation pin head is spherical so as not to provide any sharp edges which could damage soft tissue. A hexagonal-shaped hole is on the top surface of the sphere such that the bone threads attached to the spherical head can be turned with a hexagonal tool. The positioning slot is formed by two intersecting circles. The larger circle is slightly larger than the diameter of the spherical head. The smaller circle is slightly larger than the shaft under the spherical head of the fixation pin. The dimensions of the positioning portion of the slot are designed to allow it to pass over the spherical head pin previously installed on the bone. The slot is positioned such that the shaft under the spherical head coincides with the smaller diameter of the slot. Additionally, the bottom surface of the spherical head is locked on the chamfered edge at the smaller diameter end of the slot. It is held together with the compressive force from the screw or the airbag expansion device. See Figures 15C to 15E 。

[0184] When assembled, the threaded ends of rods 1522a, 1522b and threaded member 1524 pass through holes 1566, 1568, 1572, 1582, 1584, 1586. This ensures proper alignment of the components. The attachment member 1580 is fixed to the palate using bone screws 1592, 1594. Then, the component 1500 is adjusted by turning the threads on the threaded member 1524 such that it applies a constant outward force to the palate through screws 1592, 1594. This force forms the background static force mentioned elsewhere in this application. Then, in use, a hydraulic pump (not shown) is used to periodically inflate and deflate the airbag 1544. When the airbag 1544 is inflated, it is used to extend beyond the plane of the outer surface containing the channel member 1560 and thus applies an additional force on the inner surface of the attachment member 1580. When this occurs simultaneously, on both sides of the mechanism 1500, the area between the two pairs of screws is subjected to a tensile force which, in one application, promotes maxillary expansion through the separation of the palatal sutures.

[0185] Figures 16A to 16D Examples of inserts that can be worn on teeth in combination with devices according to other embodiments of the present invention are shown for the purpose of avoiding, correcting or increasing tooth inclination during a reconstruction process. The insert includes a molded retainer-like member having recesses molded to conform to the outer surface of the teeth. Each recess / depression is shaped such that the inner surface of the device makes close contact with the tooth surface, the uppermost part of the tooth and a portion of the outer surface, and there is a structure on the corresponding inner surface of the recess, in this example, cantilever fingers. Figure 16C and 16D A small gap is shown to exist between the outer surface of the tooth and the outer wall of the device, allowing the tooth to move and tilt and then being prevented from further rotation and starting to upright as further force is applied. The insert is preferably used in combination with an embodiment such as Figures 11 to 12B shown such that the airbag expands against the insert rather than directly against the tooth. The structure in the recess is preferably positioned such that when the airbag expands against the insert, the force is transmitted to the tooth through the fingers rather than through the entire inner surface of the recess. By ensuring that the cantilever fingers contact the tooth at the inner surface near the bottom of the tooth (i.e., the "gingival end"), it can be ensured that the outward force applied to the tooth acts to widen the dental arch by promoting tooth translation. Figures 16A to 16D The embodiment shown is a maxillary device, but those skilled in the art will understand that a mandibular device is equally feasible.

[0186] Figures 17A to 17CShows various ways in which devices 700, 800, 900 can be mounted on user U. It should be noted that the oral components of these devices 700, 800, 900 can be used for maxilla / mandible widening as shown in FIGS. 1 to 2, or alternatively, as described below, they can be used for maxilla or mandible protraction (forward movement).

[0187] Figure 17A An embodiment of which includes a harness 702 having a central chest 704 from which four straps 706, 708, 710, 712 extend. The back of the harness (not shown) includes a single backplate that is integrally formed with the headplate 714. An additional strap 716 spans across the forehead of user U to tightly secure the user's head to the headplate 714. Device 700 includes a force generator 718 configured to generate a periodic linear force within a connector 720. The force can be generated by, for example, a motor or a pump. There is a bend B at the upper end of the connector 720 and a portion 722 that enters the oral cavity of user U. Inside the user's oral cavity, a rod can be connected to the maxilla or mandible, and as a result of the periodic force, the rod can apply a force to the bone that is used to cause forward displacement of the maxilla / mandible, thereby causing protraction of the bone. The presence of the harness 702 with the chest plate 704, backplate, and headplate 714 ensures a constant distance between the bend B and the point of contact of the distal end of the portion 722 with the craniofacial feature of interest within the user's oral cavity, thereby maximizing the impact of the force on the user's craniofacial structure. Figure 17B and 17C are respectively different from Figure 17A in that in Figure 17B the connector 820 bifurcates at the bend B, and in Figure 17C there are two connectors 920a, 920b. These arrangements help to ensure optimal symmetric protraction of the ideal craniofacial structure.

[0188] Figure 18An alternative embodiment of the present invention is shown, which can be used for maxillary protraction, i.e., forward traction of the maxilla. The device 1001 includes four main components: a head support 1002, a pair of motors 1004a, 1004b, a pair of telescopic arms 1006a, 1006b, and a crossbar 1008. The head support 1002 is shaped to fit snugly on the back of the user's head and extends forward to the bottom of the user's mandible. The head support includes a back 1010 that contacts the back of the user's head, and two sides 1012a, 1012b that are integrally formed with the back 1010 and cover the sides of the user's head. Each of the sides 1012a, 1012b includes a hole 1014 for the user's ear. At the top of the head support 1002 there is an adjustment device 1016, which includes screws 1018a, 1018b for adjusting the lateral tightness of the head support 1002 to ensure a secure fit on the user's head. In front of each of the sides 1012a, 1012b there are corresponding motors 1004a, 1004b. In Figure 18 the embodiment shown, the motors 1004a, 1004b are stepper motors, but those skilled in the art will understand that other types of motors can be used in practice. Each motor 1004a, 1004b is connected to the proximal end of a corresponding telescopic arm 1006a, 1006b, and each telescopic arm serves as an extension and retraction actuator. The distal ends of the telescopic arms 1006a, 1006b are connected to the ends 1008a, 1008b of the crossbar 1008.

[0189] Figure 19The crossbar 1008 is shown in more detail in the exploded view. The crossbar 1008 includes an elongated plate 1020 having ends 1020a, 1020b. There is a wide portion 1022 in the central region of the crossbar, and narrower portions 1024a, 1024b on both sides of the wide portion 1022. Two holes 1026a, 1026b are formed in the wide portion 1022. Zeroing screws 1028a, 1028b pass through each of the holes 1026a, 1026b. On the proximal side N of the plate 1020, wave springs 1030a, 1030b and tension collars 1032a, 1032b are located at the ends of the respective screws 1028a, 1028b. On the distal side F of the plate 1020, tie rods or cables 1034a, 1034b are attached to the ends of the screws 1028a, 1028b, and bone screws 1036a, 1036b are positioned at the distal ends of the screws. To assemble the device, the crossbar 1008 is in the fully retracted position (i.e., the telescopic arms 1006a, 1006b are fully retracted). Then, the tie rods or cables 1034a, 1034b are attached between the bone screws 1036a, 1036b and the screws 1028a, 1028b, and the attachment mechanism can also be easily reversible, such as a hook or buckle between the bone screw and the tie rod or cable. Then the tension collars 1032a, 1032b are rotated until a predetermined tension can be felt in the bone screws 1036a, 1036b.

[0190] In operation, the movement of the stepper motors 1004a, 1004b is converted into the extension / retraction of the telescopic arms 1006a, 1006b, causing the crossbar 1008 to move back and forth in front of the user's face. In particular, when the telescopic arms 1006a, 1006b extend, the plate 1020 moves away from the user's face, causing compression of the wave springs 1030a, 1030b, which causes displacement of the screws 1028a, 1028b, thus causing a change in the tension in the bone screws 1036a, 1036b. By selecting the displacement curve of the crossbar 1008 relative to the head support 1002 caused by the movement of the motors 1004a, 1004b, a curve of tension versus time can thus be constructed in the bone screws 1036a, 1036b. Alternatively or additionally, the telescopic arms 1006a, 1006b (and other components) can be adjusted manually or by actuation of a component.

[0191] Figure 20A and 20B An alternative crossbar structure 1108 is shown, where the same numbers refer to the same features as in Figure 19 above. Figure 20A and 20B The crossbar 1108 of Figure 19 differs from the crossbar 1008 of above in that it also includes strain gauges 1138a, 1138b for measuring the strain in the tie rods or cables 1134a, 1134b.

[0192] Figure 21 A device similar to Figure 18 except that the actuator is a hydraulic pump instead of a stepper motor. This arrangement is shown in more detail in Figures 22A to 22C Hydraulic air bags are used to increase the distance between the lifting plate and the rear lifting plate, thereby increasing the tension of the tie rod / cable.

[0193] Figure 22A An exploded view of the crossbar structure is shown. The operation of this structure is as follows:

[0194] - The hydraulic actuator is in the fully retracted position and the hydraulic air bag is contracted.

[0195] - The tie rod / cable is attached between the bone screw and the non-rotating slider.

[0196] - Then turn the zeroing screw until tension is felt in the bone screw.

[0197] - At this time, the lifting plate is flush with the front bracket.

[0198] - Now, the device is in the "rest position".

[0199] - Coarse oscillation can be achieved by extending and retracting the hydraulic actuator.

[0200] - The pressure change in the hydraulic actuator provides feedback information on loading the bone. This provides a low-frequency potential oscillating force in one example.

[0201] - The pressure change in the hydraulic air bag moves the lifting plate forward, thereby applying a load to the bone. The pressure change in the hydraulic air bag also provides feedback information on loading the bone. This is used for small high-frequency pulsating forces.

[0202] As described herein, each hydraulically actuated head bracket device can be configured with at least one detachable self-sealing connection. The self-sealing connection can include, for example, at least one of a check valve and a reversible valve. The self-sealing connection is configured such that the hydraulic pump can be reversibly connected to one or more hydraulic air bags without affecting the hydraulic pressure in these air bags.

[0203] Figure 22B and 22C The lifting plate assembly is shown in more detail and can be described as follows:

[0204] - The universal fixture sliders are connected together by two parallel slide rails in the front and back, and the slide rails slide freely through two slide rail bushings.

[0205] - The bushings are fixed to the fixed structure.

[0206] - The zeroing screw is connected to a rod or cable connected to the skull.

[0207] - In the contracted state, the front universal fixture slider (front) contacts the vertical surface of the fixed structure. This is the stationary state.

[0208] - When the hydraulic airbag expands, the universal fixture slider (front) is forced away from the vertical fixed surface.

[0209] - The direction will be to the left and cause the zeroing screw to create tension in the rod or cable connected to the skull.

[0210] - By changing the volume of the hydraulic fluid in the hydraulic airbag, the distance between the universal fixture slider (front) and the tension in the fixed structure in the rod or cable will change and thus the tension applied in the cable or rod connected to the skull will also change.

[0211] - To create compression on the skull through the rod, the universal fixture slider (rear) must be pushed in the right - hand direction. This can be achieved by positioning the hydraulic airbag on the right side of the fixed structure and inflating the hydraulic airbag, forcing the universal fixture slider (rear) away from the fixed structure and pushing the zeroing screw to the right - hand side.

[0212] Figure 23 shows a device similar to Figure 18 the device, except there are two sets of stepper motors and two crossbars. In this way, a protrusion force can be evenly applied within the vertical range of the skull.

[0213] Figure 24 shows an alternative arrangement where a rigid bow - shaped support is fixed to the skull using bone screws or other suitable fasteners. A rigid center rod is attached to the center of the rigid bow - shaped support, and the other end of the step is attached to a crossbar, such as Figures 19 to 20B the crossbar in Figure 21 The device operates in a manner similar to the device in, for example, Figure 21 except for the fact that the device is fixed to the skull by bone screws rather than by friction between the user's head and the inner surface of the head - support structure. As described above, the corrective force applied by the device is generated by an actuator. The actuator can include a hydraulic pump or a stepper motor and can be mounted to the rigid bow - shaped support. The actuator is removably mounted on the bow - shaped support. In addition, the crossbar can also be removed from the wider structural arrangement.

[0214] Figures 25A to 25F is a schematic diagram of an embodiment where a force is applied to the space between the cheekbone and the maxilla. In the shown embodiment, an L - shaped connector is employed, and its outer end (i.e., the end not in contact with the skull) can be attached to a device, such as Figures 17A to 17C the devices shown in 18, 21, 23, 24, 26, 29A, 30, 31A, 32A, 34A. In Figure 25A and 25BIn [reference], the L-shaped connector is configured for maxillary protraction, and in Figure 25C it is configured for maxillary expansion. It should be noted that although the connector in Figures 25D to 25F is shown as a sharp L-shape, in a preferred embodiment of the present invention, the connector will be shaped to the contour of the bone surface under discussion and allow any occupancy of the inflatable structure. Figures 25D to 25F Three different ways in which force can be transmitted to the relevant cranial structures are shown:

[0215] - In Figure 25D a rigid connector is placed between the zygomatic bone and the maxilla, and the force transmitted from the force generator to the connector is directly transmitted to the zygomatic bone to promote bone growth and / or bone displacement.

[0216] - In Figure 25E an airbag is positioned between the connector and the zygomatic bone. The connector is fixed in place and can apply a constant force to the bone. Through the periodic inflation and deflation of the airbag, the force is transmitted to the zygomatic bone. In some embodiments, the airbag can be dynamically inflated / deflated to provide an "active cushioning" effect upon actuation of the connector.

[0217] - In Figure 25F there is no rigid connector, and a regular or shaped airbag fills the space between the maxilla and the zygomatic bone. In such an embodiment, when the airbag is periodically inflated / deflated, the zygomatic bone is laterally displaced (since it is less resistant to movement than the maxilla). Any adverse compression of the maxilla can be overcome by using, for example, Figure 25D or the arrangement of 25E within the palate, or by using other intraoral devices such as those described elsewhere in this patent application.

[0218] Figure 26 The device 1300 is similar to, for example, the device shown in Figure 18 but is used when the user is lying horizontally rather than sitting or standing upright. It can be understood that similar reference numerals are used below to denote similar structures. The device 1300 includes a head support 1302, motors 1304a, 1304b, telescopic arms 1306a, 1306b, and a crossbar 1308. The head support 1302 includes a headrest 1310 and sides 1312a, 1312b, and the headrest 1310 includes a cavity for receiving the head. In a "lying flat" device such as Figure 26 shown, during the application of the periodic force, the weight of the user's head is used to prevent the user's head from moving forward.

[0219] The head support 1302 optionally further includes additional frame elements 1340 (only one is shown, but those skilled in the art will understand that there can be one on each side or none at all), which are integrally formed with the sides 1312a, 1312b. Each frame element 1340 includes a slot 1342 into which corresponding protrusions on the motors 1304a, 1304b are fitted. The operation of the device 1300 is the same as that of the previous device, but with a different orientation.

[0220] Figures 27A to 27B An alternative example is shown where the connector between the crossbar and the actuator can be rotated, as shown for example, to connect the pull rod to the intranasal structure. Figure 28 The device shown is arranged to reconstruct the proximal cranial structure including the ethmoid bone. In an alternative arrangement, the head support is configured such that the attachment points are provided at the zygomatic or cheekbones. The frame elements and the motors are configured to generate a dilating force which is applied to the zygomatic bones in a generally upward direction. It is recognized that although the force applied by the frame elements is dilating, the patient will experience a compressive force.

[0221] Figure 29A and 29B An alternative embodiment of the device is shown which is capable of applying a more diverse range of cyclic forces to the craniofacial structure of the user. The device 2000 includes a body portion 2002 which includes sides 2004a, 2004b mounted on a base 2006. Each side 2004a, 2004b includes a semi-circular portion 2008a, 2008b which includes semi-circular recesses 2010a, 2010b, the recesses 2010a, 2010b being defined by inner walls 2012a, 2012b and outer walls 2014a, 2014b. Each of the inner walls 2012a, 2012b includes a slot 2016a, 2016b and each of the outer walls 2014a, 2014b includes a slot such as 2018a. The space between the sides 2004a, 2004b is approximately the width of a human head.

[0222] The device 2000 further includes five arcuate tracks 2020, 2022, 2024, 2026, 2028. Those skilled in the art will understand that other embodiments of the invention can have fewer (i.e., one, two, three or four) tracks or more tracks. In the embodiment shown, each of the arcuate tracks 2020, 2022, 2024, 2026, 2028 is semi-circular, but other arcuate shapes can equivalently be used. Each end of each of the arcuate tracks 2020, 2022, 2024, 2026, 2028 is located within a corresponding one of the semi-circular recesses 2010a, 2010b and has a protrusion extending through each of the inner slots 2016a, 2016b and the outer slot such as 2018a.

[0223] Each arcuate track 2020, 2022, 2024, 2026, 2028 includes mounting grooves or slots 2030, 2032, 2034, 2036, 2038 extending along most or all of its length. Generally, these slots 2030, 2032, 2034, 2036, 2038 are used to mount components on the arcuate track in question, which components can be force generators, force transmitters (or both), or anchors.

[0224] In Figure 29A it is apparent that each of the arcuate tracks 2020, 2024, 2026, and 2028 has a different attachment. A vibrating plate assembly 2040 is mounted on track 2020. The vibrating plate assembly includes a vibrating plate 2042, a force generator 2044, a rod 2046 (which can be telescopic), and a mount 2048. The force generator 2044 is mounted to track 2020 via the mount 2048. The output of the force generator 2044 is transmitted to the rod 2046 and then to the vibrating plate 2042. In this case, the vibrating plate is flat, but in some alternative embodiments, the plate can be shaped to fit various craniofacial structures. It should be understood that although Figure 29A the embodiment of

[0225] only shows a single track 2020 with a vibrating plate assembly 2040, other embodiments can have additional vibrating plate assemblies. In an embodiment where, for example, an upward force is applied by one or more force transmitters, the plate may not vibrate and can be used as an anchor to limit movement of the head in response to the applied periodic force, thereby maximizing the effect of the force.

[0226] Components 2050 and 2052 are compression force transmitters that operate in the same manner as the vibrating plate assembly 2040 but have plates 2062 of different shapes (i.e., smaller).

[0227] In Figure 29A the embodiment shown, component 2050 is capable of rotating relative to track 2024 so as to change the direction in which it can apply a compression force.

[0228] Figure 30 shows an embodiment similar to Figure 29A wherein a head pad is mounted on a base.

[0229] Figure 31A and 31B shows a device similar to that of Figure 29A and 29B except that the tracks 2120, 2122 are vertically oriented instead of horizontally oriented, and thus can rotate around the user's head from left to right instead of from top to bottom. The components located on the tracks can move in the up - down direction along their respective tracks. It should also be noted that one of the tracks includes rollers. The rollers are not limited to this embodiment and can be featured in any embodiment of the present invention.

[0230] Figure 32A and 32B shows an improved version of the device with vertical tracks, wherein the walls are removed to reduce the restriction on lateral movement. This example shows a frame for positioning two opposing pressure pads. These pressure pads are positioned across the skull. The actuator can apply a variable force to the skull surface. In addition, the pressure pads can oscillate about their axes to apply torque to the skull surface. These oscillations can be limited to + / - 45°, for example, pushing down a quarter turn. These oscillations can be uniformly sinusoidal or random.

[0231] In one example, one pressure pad can apply an inward rotational force while the other side can apply no or a constant opposing force to restrict head movement.

[0232] Figure 33A and 33B shows a cranial reconstruction helmet 3300 according to an embodiment of the third aspect of the present invention. The inner surface of the helmet 3300 is shaped to conform to the outer surface of the user's head. As Figure 33B shown, the inner surface of the helmet 3300 includes a plurality of columnar airbags 3302. Although Figure 33BIt shows that the airbag 3302 only covers a part of the inner surface of the helmet 3300. However, those skilled in the art will understand that the present invention covers embodiments in which any number of the inner surfaces of the helmet 3300 are covered by the ring 3302. Those skilled in the art will also note that the airbag does not have to be annular. In use, the two anchor points can correspond to two points on the user's skull that are opposite to each other, and the two anchors of the skull reconstruction device correspond to the parts of the inner surface of the helmet 3300 that contact these anchor points. By the periodic expansion and contraction of the airbag 3302, a periodic force can be applied to the skull. In a preferred embodiment, the helmet 3300 is sized to fit tightly on the user's head to provide a "background" compressive force, which is then supplemented by the periodic force provided by the expansion and contraction of the airbag 3302. The airbags can be directly connected to a hydraulic compressor individually, or they can be daisy-chained so that the entire airbag block will expand simultaneously. As the hydraulic airbag contracts, the helmet is placed on the head and the airbag expands. The airbag pressure can be varied to any waveform that is desired to produce a pulsating massage effect. By correctly interconnecting the airbags and multiple pressure lines to the compressor, the airbags can achieve a undulating massage sequence when expanding / contracting in sequence. Note that in this and all other embodiments of the present invention, there can be multiple airbags, which can have different shapes, sizes, orientations, and positions (including the proximity to the skull). The airbags can also be of different textures. There can be additional elements to replace the inflated airbags, or equivalently, the inflated airbags can replace the additional elements.

[0233] Figures 34A to 34C is a schematic diagram of a skull cranial device. In Figure 34A , the user places their head on a lower seat that includes a recess to allow it to better conform to the shape of the user's head. Then, the upper part can be lowered onto the user's face. The device is preferably configured to fit tightly on the user's face to provide a background force. Then, a periodic force can be applied hydraulically, for example, using a ring airbag as shown in Figure 33A and 33B . Alternatively, the upper part can have other components that apply compressive force or tension, such as the compressive force transmitters shown in Figure 29A and 31 and 32B. Figure 34B and 34C show other device configurations in which the device according to the present invention can be installed.

[0234] Figure 34D and 34E show similar embodiments with a "butterfly" arrangement, where two sides come together inwardly across the user's face.

[0235] Figures 34A to 34EThe illustrated embodiments can be modified to provide tension rather than compressive forces to the cranial structure. For example, the attachment portions located on the inner surface of the device can be arranged to connect to, for example, bone screws or other fixation devices on the user's skull such that tension is applied to the fixation devices. This would represent the background force, and periodic forces can be hydraulically applied thereon in the same manner as in other embodiments.

[0236] Figure 35 A horizontal platform is shown that is shaped for access to a mouth connected to an actuator by two arms, and the actuator can be mounted to a backplate or track, such as shown in FIGS. 29, 30, 31, and 32. When the platform is actuated, it applies a force to an anchor point in the oral cavity.

[0237] Figure 36A and 36B Structures attached to the horizontal platform are shown and in these examples are arranged to apply a force to the palate without involving the teeth. As Figure 36A shown, an expandable structure is arranged between the lateral arms of the device and the horizontal platform. In Figure 36B an alternative arrangement shown, the expandable structure is arranged between the palate and the curved surface of the device. In Figure 36A and 36B each arrangement shown, the expandable structure is used to apply a force to the palate. In Figure 36A , the force is applied by actuation of the device, and in Figure 36B the case of the arrangement shown, the force is applied directly to the palate. In each of these arrangements, the horizontal platform is fixed in place by applying a constant force indirectly (i.e., through an intraoral device) or not applying a constant force at all. When the horizontal platform is actuated, the expandable pads can also act as an "active buffer". For example, the expandable structures can be sealed such that they can passively absorb the forces acting on them by the platform. Alternatively, the expandable structures can be connected to a hydraulic actuator configured to cause the application of a constant or dynamic force.

[0238] According to Figure 36A and 36B an alternative arrangement to the arrangement shown, the expandable structure can be arranged between the arms of the device and the occlusal surfaces of the teeth. Thus, activation of these expandable structures will result in the direct application of a force on the teeth. In addition to Figure 36A and 36B the arrangements shown, this arrangement of the expandable structure can also be provided.

[0239] Figure 38A and 38B show a Matthews-Tessier retractor that can be used in combination with embodiments of the present invention.

[0240] Although the present invention has been described in connection with the above exemplary embodiments, many equivalent modifications and variations will be apparent to those skilled in the art when given this disclosure. Accordingly, the above exemplary embodiments of the present invention are considered to be illustrative and not restrictive. Various changes may be made to the described embodiments without departing from the scope of the present invention. All of the references mentioned above are hereby incorporated by reference.

Claims

1. An apparatus for cranial reconstruction by dilation, compression, or bending of a cranial structure located between a first anchor point and a second anchor point, the apparatus comprising: A force generator configured to generate a force; A first anchor for attachment to the first anchor point; A second anchor for attachment to the second anchor point; A hydraulic force transmission structure connected to the force generator and configured to transmit the force to the first and second anchors, thereby placing the cranial structure in at least one of: tension, compression, or bending, wherein the force transmission structure is a hydraulic force transmission structure.

2. The apparatus according to claim 1, wherein: The generated force includes a periodic component.

3. The apparatus according to claim 1 or 2, wherein: The generated force is constant or substantially constant.

4. The apparatus according to any one of claims 1 to 3, wherein: The force transmission structure includes an expandable structure.

5. The apparatus according to claim 4, wherein: The force transmission structure includes a first expandable structure rigidly connected to the first anchor and a second expandable structure rigidly connected to the second anchor.

6. The apparatus according to claim 5, wherein: The first expandable structure and the second expandable structure are connected in series with each other.

7. The apparatus according to any one of claims 4 to 6, wherein: The force transmission structure includes a first channel containing the expandable structure.

8. The apparatus according to claim 7, wherein: The force transmission structure includes a molded structure that includes a first recess shaped to conform to at least one of: the inner surface, outer surface, and occlusal surface of a first tooth, the recess including a first intermediate structure, the surface of the first intermediate structure being arranged to contact the surface of the first tooth when the apparatus is in a proper position within a user's oral cavity.

9. The apparatus according to claim 8, wherein: The first channel is located within a portion of the molded structure that is behind the first intermediate structure, and the expandable structure is arranged such that when it expands, it applies a force on the first intermediate structure, and the force is transmitted to the first tooth via the first intermediate structure.

10. The apparatus according to claim 9, wherein: The molded structure includes a plurality of recesses, each recess shaped to conform to the inner surface of a corresponding tooth, and each recess includes a corresponding intermediate structure, the surface of the corresponding intermediate structure being arranged to contact the surface of the corresponding tooth when the apparatus is in a proper position within the user's oral cavity.

11. The apparatus according to claim 10, wherein: The first channel is arcuate and is located behind each corresponding cantilever structure such that when the expandable structure expands, it applies a force on each intermediate structure, and the force is transmitted to each tooth through the corresponding intermediate structure.

12. The device according to any one of claims 7 to 11, wherein The intermediate structure is at least one of: a cantilever structure, a sliding member, and a weakened portion of the wall of the recess.

13. The apparatus according to any one of claims 1 to 12, wherein: The apparatus is modular.

14. The apparatus according to any one of claims 1 to 13, wherein: The force generator is removable.

15. The device according to any one of claims 1 to 14, wherein: The force generator is connectable to at least a part of the force transmission structure by a detachable self-sealing connection.

16. The device according to any one of claims 1 to 15, wherein: The detachable self-sealing connection includes a valve.

17. The device according to any one of claims 1 to 16, wherein: The detachable self-sealing connection includes at least one of a check valve and a reversible valve.

18. The device according to any one of claims 1 to 17, wherein: The force transmission structure is configured to transmit a first force to the first anchor and a second force to the second anchor, wherein the first force and the second force are in opposite directions.

19. The device according to claim 18, wherein: The force transmission structure is configured to directly apply only the generated force to the first anchor, and wherein in use, the first force is applied to the second anchor via the skull structure as a reaction force.

20. The device according to any one of claims 1 to 19, wherein: The force transmission structure is configured to directly apply the generated force to the first anchor and the second anchor.

21. The device according to claim 1, wherein The device defines a dilation mechanism for performing maxillary or mandibular dilation. The hydraulic force transmission structure includes first and second hydraulic components, first and second channel components arranged to respectively accommodate the first and second hydraulic components, and a central component arranged to couple the first and second channel components; The first anchor point defines an attachment component of the first channel component, and the second anchor point defines an attachment component of the second channel component.

22. The device according to claim 21, wherein, The attachment component includes wings extending from the body of the attachment component, and the wings include holes configured to receive fasteners, and the fasteners are configured to fasten the attachment device to the skull structure of the user.

23. The apparatus according to claim 22, wherein, The holes include positioning slots, and the positioning slots are configured to releasably couple the wings to the fasteners, wherein the positioning slots include two intersecting round holes, namely a first hole larger than the head diameter of the fastener and a second smaller hole larger than the shaft diameter of the fastener and smaller than the head diameter of the fastener.

24. A device for performing skull reconstruction by dilation, compression or bending of a skull structure having a first anchor point, the device comprising: A head support having a head receiving portion configured to receive a part of the user's head; A force generator configured to generate a periodic force; A first anchor for attachment to the first anchor point; A force transmission structure connected to the force generator and configured to transmit the periodic force in the reconstruction direction to the first anchor; Wherein, the head support includes: A restricting device configured to prevent or restrict movement of the user's head in the reconstruction direction during use when a periodic force is applied.

25. The device according to claim 24, wherein: The force transmission structure is a hydraulic force transmission structure.

26. A device for performing skull reconstruction by dilation, compression or bending of a skull structure having a first anchor point, the device comprising: A head support having a head receiving portion configured to receive a part of the user's head; A force generator configured to generate a force; A first anchor for attachment to a first anchor point; A force transmission structure connected to the force generator and configured to transmit a periodic force in a reconstruction direction to the first anchor, wherein the force transmission structure is a hydraulic force transmission structure; Wherein, the head support includes: A restraint device configured to prevent or limit movement of the user's head in the reconstruction direction during use when a periodic force is applied.

27. The device according to claim 26, wherein: The generated force is constant or substantially constant.

28. The device according to claim 26, wherein: The generated force includes a periodic component.

29. The device according to any one of claims 24 to 28, wherein: The first anchor is a screw configured to contact bone or soft tissue; The force transmission structure includes one or more wires or rods connecting the force generator to the screw.

30. The device according to any one of claims 24 to 29, wherein: The head support is configured to tighten around the user's head such that a force is applied to the side, front, or back of the user's head and / or face, such that the inner surface of the head support forms at least a portion of the restraint device and restricts movement of the user's head by friction.

31. The device according to any one of claims 24 to 30, wherein: The restraint device includes an abutment surface configured to abut the user's head during use, wherein contact with the abutment surface is configured to prevent or limit movement of the user's head in the reconstruction direction.

32. The device according to any one of claims 24 to 31, wherein: The device includes a bracket having a track.

33. The device according to claim 32, wherein: The track is connected to the head support by one or more connectors.

34. The device according to claim 33, wherein: The device includes a first connector and a second connector, and the track is attached to the end of the connector remote from the force generator.

35. The device according to claim 34, wherein: The device further includes a third connector connected to the track at the proximal end and to the first anchor at the distal end.

36. The device according to any one of claims 24 to 35, wherein: The device further includes a second anchor for connection to a second anchor point of the cranial structure.

37. The device according to claim 36, wherein: The device further includes a fourth connector connected to the track at the proximal end and to the first anchor at the distal end.

38. The device according to any one of claims 24 to 37, wherein: The device includes a plurality of tracks.

39. The device according to claim 38, wherein: Each of the plurality of tracks is connected to at least one force generator by at least one connector.

40. The device according to any one of claims 24 to 39, wherein: The restraint device is located on the track.

41. The device according to any one of claims 24 to 40, wherein: The force generator includes one or more of a motor and a hydraulic pump.

42. The device according to any one of claims 1 to 41, wherein: the first anchor point is a first tooth, and the first anchor includes a first tooth contact member configured to: wrap around the first tooth, or abut against an inner or outer surface of the first tooth.

43. The device according to claim 42, wherein: the first tooth contact member includes one or more of the following: a wire, a band, a plate, or another orthodontic fixture.

44. The device according to claim 42 or 43, wherein: the second anchor point is a second tooth, and the second anchor includes a second tooth contact member configured to: wrap around the second tooth, or abut against an inner or outer surface of the second tooth.

45. The device according to claim 44, wherein: the second tooth contact member includes one or more of the following: a wire, a band, a plate, or another orthodontic fixture.

46. The device according to any one of claims 42 to 45, wherein: the first tooth contact member or the second tooth contact member includes a portion shaped to conform to the surface of the first tooth or the second tooth, respectively.

47. The device according to any one of claims 1 to 46, wherein: one or both of the first anchor and the second anchor include a screw configured to directly contact bone or soft tissue.

48. A device for cranial compression, comprising: a head support unit configured to apply a compressive force on at least a portion of a user's skull; a force generator configured to generate a force, the generated force being periodic; and a force transmission structure configured to transmit the periodic force to the user's skull.

49. The device according to claim 48, wherein: the force transmission structure is a hydraulic force transmission structure.

50. A device for cranial compression, comprising: a head support unit configured to apply a compressive force on at least a portion of a user's skull; a force generator configured to generate a force; and a force transmission structure configured to transmit a periodic force to the user's skull, the force transmission structure being a hydraulic force transmission structure.

51. The device according to claim 50, wherein: the generated force includes a periodic component.

52. The device according to claim 51, wherein: the generated force is constant or substantially constant.

53. The device according to any one of claims 48 to 52, wherein: the head support includes a helmet, the inner surface of which is shaped or molded to conform to the outer surface of the user's head.

54. The device according to any one of claims 48 to 53, wherein: the head support includes a first portion positioned to cover a cranial structure to be compressed and a second portion positioned opposite to the cranial structure.

55. The device according to any one of claims 48 to 54, wherein: the head support includes a first portion and a second portion movable relative to each other, and means for connecting the first portion and the second portion in such a way that the respective inner surfaces of the first portion and the second portion are configured to apply a compressive force on the user's skull.

56. The device according to any one of claims 1 to 55, wherein: the force generator is configured to generate a force having a profile including an aperiodic region and a periodic region.

57. The device according to any one of claims 1 to 56, wherein: the force generator is configured to receive an input from a measuring device and to adjust the characteristics of the generated force in response to the input from the measuring device.

58. The device according to any one of claims 1 to 57, wherein: the force generator is configured to adjust the characteristics of the force to maintain a constant remodeling rate of the skull structure.

59. The device according to any one of claims 1 to 58, wherein: the measuring device includes: a manometer, a strain gauge, a device for measuring the displacement of the skull structure, an electrocardiograph, an electroencephalograph or an electromyograph.

60. The device according to any one of claims 1 to 59, wherein: the device includes a first component configured to deliver a static force to the first anchor and / or the second anchor, and a second component configured to deliver a periodic force to the first anchor and / or the second anchor.

61. The device according to any one of claims 1 to 60, wherein: the first component is adjustable.

62. The device according to any one of claims 1 to 61, wherein: the force generator is an external force generator.

63. The device according to any one of claims 1 to 62, wherein: the force transmission structure is configured to transmit the force from outside the user's body to a location inside the user's body.

64. The device according to any one of claims 1 to 63, wherein: the force generator is located in a housing configured to be attached to a harness.

65. The device according to any one of claims 1 to 64, wherein: the force transmission structure includes one or more inextensible and incompressible lines configured to transmit the force as a tension.

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