Skull reconstruction device

Abstract

A device for skull reconstruction by expansion, compression or bending of a skull structure between a first anchor point and a second anchor point, comprising: a force generator configured to generate a force that may be cyclical; a first anchor for attachment to the first anchor point; a second anchor for attachment to the second anchor point; a force transfer structure, which may be hydraulic, connected to the force generator and configured to transfer the generated force to the first anchor and the second anchor, thereby placing the skull structure in at least one of: tension, compression or bending. Another device for skull reconstruction by expansion, compression or bending of a skull structure having a first anchor point, 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 that may be cyclical; a first anchor for attachment to the first anchor point; a force transfer structure, which may be hydraulic, connected to the force generator and configured to transfer the cyclical force to the first anchor in a reconstruction direction; wherein the head support includes: a limiting device configured to prevent or limit movement of the user's head in the reconstruction direction when the cyclical force is applied in use. Another device for skull compression includes: a head support unit configured to apply pressure on at least a portion of a user's skull; a force generator configured to generate force; and a force transfer structure configured to transfer periodic force to the user's skull, the force transfer structure being a hydraulic force transfer structure.

Description

Technical Field

[0001] The present invention relates to a device for achieving skull and / or orthodontic reconstruction primarily through the action of periodic forces. Background Art

[0002] 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, the force experienced by each tooth decays over time as the teeth change position.

[0003] In many cases, the device must be worn 24 hours a day, such as fixed braces, and constantly applies force to the user's teeth to have any meaningful effect. This can become uncomfortable for the user. A similar situation arises when attempting to correct the user's facial bone structure. This often requires a bulky support structure, such as a headgear, which may be removable or fixed in the form of a skull distraction device, and in the case of fixed devices, often requires more than 12 hours of wear time or constant use. Summary of the invention

[0004] In summary, the present invention aims to solve this problem by providing a device configured to apply cyclical forces to bones, teeth or other parts of the body to reshape their structure, such as by expansion, compression or protrusion. As described below, in some cases, the applied cyclical forces are superimposed on the static forces to increase the efficacy.

[0005] The first aspect of the present invention is mainly related to a device configured to perform reconstruction of the maxilla, mandible, dental arch or palate, but it should be understood that the device according to the 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 achieves this by providing a device for performing skull reconstruction by expansion, compression or bending of skull structures located between a first anchor point and a second anchor point, the device comprising:

[0006] a force generator configured to generate a periodic force;

[0007] a first anchor for attachment to a first anchor point;

[0008] a second anchor for attachment to a second anchor point;

[0009] A force transmitting structure connected to the force generator and configured to transmit a periodic force to the first anchor and the second anchor to place the skull structure in at least one of: tension, compression, or flexion. It is recognized that there may be more than two anchors and that one anchor point may constitute a group of structures.

[0010] It has been shown that applying dynamic forces to bone structures results in greater bone growth compared to static forces. The combination of static and dynamic forces has also been shown to accelerate tooth movement. This is advantageous because it reduces treatment time and minimizes the amount of pain / discomfort experienced by the user. It also minimizes or eliminates the need to wear static braces or oral appliances / retainers for extended periods of time.

[0011] Throughout this application, it is understood that forces applied to the teeth may also result in compression and tension of intermediate structures such as the periodontal ligament, and that the effects on tooth movement and bone remodeling will be different under different loading schemes. It should also be understood that skull structures and sutures may be subjected to different amounts of compression and / or tension, depending on the loading scheme.

[0012] 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 quasi-periodic forces, where, for example, the frequency or time period changes. 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., 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 the following: triangular, sinusoidal, sawtooth, pointed or square. The force can also be any superposition of these. Other periodic waveforms should be understood to be included in this definition.

[0013] The periodic force is preferably a unidirectional force. In other words, the effect of the periodic force is preferably not a "push-pull" effect, but a push or pull effect that varies periodically (or quasi-periodically) over time. In this way, the force applied to the main cranial structure causes reconstruction only in 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 non-periodic 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 with a profile of alternating periodic and non-periodic regions. In some embodiments, the non-periodic region can include a constant force, while in other regions, the non-periodic region can include a linear or otherwise increasing / decreasing force. In a preferred embodiment, the periodic / quasi-periodic portion of the force preferably oscillates around a non-zero force. Preferably, when the force oscillates around the non-zero force, the minimum value of the oscillation is not less than zero. In this way, it can be ensured that the force is always applied to the main cranial structure in question. This is in contrast to a force oscillating around a zero point, where no force may be applied for about half of the time. 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 pressure gauge, a strain gauge, a device that measures the displacement of a cranial structure or other body structure. Other forms of input are also contemplated, such as an electrocardiogram (ECG), an electroencephalogram (EEG), and an electromyogram (EMG). In this way, the device can operate as a feedback system. In some cases, feedback can come from the operation of one embodiment, informing one or more other devices of the activity. A constant dispersion rate can be achieved by using a hydraulic combined with a displacement feedback mechanism.

[0014] It should be noted that throughout this application we refer to a "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 the time of contact is preferably constant.

[0015] If the force is provided by, for example, a tensioned wire or inflatable structure, the tension in the wire (or inflatable structure) will decrease as the structure moves, i.e., the static force will decrease very slowly over time. Throughout this application, these forces are still referred to as "static forces" or "constant forces", even though they change gradually over time. Throughout this application, the terms "constant force" and "static force" should still be considered to include forces that change only by a negligible amount, or not at all, on the time scale of one cycle of a periodic force. An actuator with a feedback loop can produce a "true" constant force. As the structure moves, the pressure in the system drops and is corrected to its initial value, thereby maintaining a constant force. After one correction or a series of corrections, the contact surface area between the anchor point and the anchor may change.

[0016] In some cases, there may be two ways to apply force to the first anchor or the second anchor. Specifically, the first component may apply a static force to the first anchor and / or the second anchor, and the second component may apply a periodic force to the first anchor and / or the second anchor. In this way, a constant "background" force may be applied, and the periodic force generated by the force generator may be superimposed thereon. Preferably, the force provided by the first component is adjustable, for example by a screw. The first component may be in the form of a well-known oral appliance, such as a static brace, retainer, or a rapid maxillary expander. In this case, when the user wears the device, the skull structure to be reconstructed is subjected to a constant static tension or stretching force. For example, if a user who needs to expand the maxillary dental arch wears such a device, the device may apply a constant force to the upper teeth in a lateral and outward direction, which acts on the teeth, causing the upper jaw to be in tension and the upper jaw to be in bending, thereby resulting in a gradual lateral maxillary expansion.

[0017] 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 then superimposed on the static component of the force provided by the static component. Alternatively, the force generator may 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 anchor point and the second anchor point respectively to ensure that the anchors can be attached to the anchor points for effective force transfer. For example, the static component may include a hole or a window. Alternatively, the static component may 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, canceling 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 for the desired reconstruction to occur.

[0018] Embodiments of the present invention are suitable for performing skull reconstruction by achieving expansion, compression or bending of skull structures. For example, in some embodiments, the device can be used for mandibular or maxillary expansion, wherein the mandibular / maxillary bone expands laterally and forwardly. Alternatively, the device can be used for maxillary or mandibular protrusion, wherein the mandibular / maxillary bone is forward, such as the bone in question. Protrusion can also stimulate growth by subjecting the bone to strain. In some embodiments, other movements can be achieved, such as retraction of teeth or maxilla. This also includes the medial or more general inward movement of teeth. In some embodiments of the present invention, movement of one or more teeth along or around any axis or their combination such as rotation is also possible. Note that in some applications of the present invention, the desired effect is the movement of two skull structures (e.g., maxillary expansion, where both the left and right sides of the maxilla are desired, i.e., bone displacement, whereby the left and right sides of the maxilla are separated by the detachment of adjacent sutures, or simply further separated without or insignificant suture fusion), while in other applications, the desired effect is the movement of one skull structure (e.g., maxillary protrusion, where the desired result is the forward movement of the maxilla). However, the mode of operation in both cases is virtually the same, since both are achieved by expanding some cranial structure in order to increase the distance between two fixed locations on the skull. The same applies to compression and flexion actions. This application covers a variety of different uses of the invention in addition to those mentioned in this paragraph. It will be appreciated that the structures in question can be treated asymmetrically, for example on one side of the maxilla with or without suture separation.

[0019] The device of the present invention works by transmitting a first force to a first anchor and a second force to a second anchor, wherein the first force is opposite, or substantially opposite, in direction to the second force. In embodiments where the first or second force is applied over a large area (e.g., between the head plate and the back of the head), the net effect of the first force is opposite, or substantially opposite, to the net effect of the second force. In some embodiments, the force transmission structure is configured to apply the first (periodic) force directly only to the first anchor. In those embodiments, the first force is transmitted to the second anchor via the skull structure, which 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 the skull structure through two anchor points generates tension or compression forces in the skull structure, and then achieves the desired skull remodeling. In some embodiments, for example when the skull structure is not located on a straight line connecting the first and second anchor points, the opposing first and second forces can instead produce bending of the skull structure. This also applies well to the case where the periodic force is applied only to the second anchor, but for the sake of simplicity, we will not repeat the description here.

[0020] In other embodiments, the force transfer structure is configured to apply a periodic force directly to the first anchor and the second anchor. Specifically, the force transfer structure is configured to apply a first force directly to the first anchor and a second force directly 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 produce tension or compression in the skull structure located between the first anchor and the second anchor.

[0021] Above, we discussed the mechanics of force transmission to the first and second anchors. Now we discuss the nature of these forces and their transmission to the first and second anchors through the force transmission structure. In some embodiments, the force generator includes a motor configured to generate rotational motion, such as a stepper motor. In this case, the force generator preferably also includes a device for converting the rotational motion into reciprocating motion. These devices may include cranks, threads or cams. Those skilled in the art know that there are a large number of other components that can be used to achieve this conversion. As discussed, the force generator is preferably an external force generator, and as is apparent, 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 transmission structure is preferably configured to transmit periodic forces from outside the user's body to inside the user's body. Specifically, in a preferred embodiment of the present invention, the force transmission structure is configured to guide the force in the front-to-back direction, that is, in the front-to-back direction relative to the user's body. Note that in some embodiments, the periodic force can be generated in this direction, in which case the force transmission structure only needs to maintain this direction, but in alternative embodiments, the force can be generated in, for example, the up-down direction, and the force transmission structure includes a mechanism for changing the direction of the force. The force generator can be located in a housing configured to be attached to the harness. In some embodiments, the harness may be a chest harness.

[0022] The force transfer structure may include one or more inextensible and incompressible wires configured to transfer the generated periodic force as a tension force. However, in a preferred embodiment of the present invention, the force transfer structure is a hydraulic force transfer structure that utilizes the incompressible properties of a fluid such as water or oil to transfer the force generated by the force generator as a compression force. The hydraulic force transfer structure preferably includes one or more expandable / contractible structures, such as an air bag or bellows, which can be inflated with a fluid to transfer the periodic force to the first anchor or the second anchor. Specific embodiments of the present invention utilizing hydraulic transfer structures will be described later in this application. Hydraulic force transfer structures are particularly effective because they have been shown to reduce the potential for mechanical system strain. In other embodiments, the force transfer may include a pneumatic or piezoelectric force transfer structure, or be in the form of a pneumatic or piezoelectric force transfer structure.

[0023] In some embodiments of the present invention, the device can be modular. In other words, any or all of the force generator, force transfer structure, first anchor, and second anchor can be removed from the device so that they can be replaced with alternative components. In other embodiments, a portion of the device can be fixed or configured to be fixed to the user's skull structure and can be connected to the rest of the device. For example, at least one of the force transfer structure, first anchor, and second anchor can be fixed or fixable to the user's skull structure and can be connected to the force generator. This modular structure is advantageous because it means that the fixed structure can be more securely fixed, such as by surgical implantation or attachment, which will result in more effective transfer of force from the force generator to the skull structure to be reshaped or reconstructed.

[0024] Modular construction is advantageous, for example the force transmitters and force generators may be removable when force generation is not required, and in some embodiments the forces may be self-sustaining or depleted. Thus, the housing structure remains as compact and unobtrusive as possible, improving patient comfort and minimizing complications such as entanglement and other forms of accidental injury.

[0025] A modular hydraulic force transmission 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 transmission structure so that the force applied by each different part can be adjusted individually. Again, this refers to a valve or other form of removable but self-sealing / sealed connection, such as a one-way valve or a reversible valve. The valve can be close to the oral appliance within the body of the device, or extend shortly therefrom. If the tubing leading out of the mouth does not protrude, the valve can be located closer to the hydraulic force generator. The valve allows the force transmitter to be detachable at any point along its length. When the device is not in use, the force transmitter may protrude and can be removed from its connection by a self-sealing valve, or it can be separated by itself. 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 fixed force, which decays over time, just like our wire under tension. Advantageously, the system can be "reset" multiple times a day (intermittently), thereby maintaining pressure and therefore force on the teeth. Alternatively, as the skull structure is displaced or reshaped, and the effective force / pressure on the structure is thus reduced, the device can be configured to increase the force provided by the force generator to ensure that a constant force is maintained on the skull structure. According to an exemplary embodiment, the self-sealing valve can be configured to allow a hydraulic fluid delivery hose or conduit to be connected to and disconnected from the first hydraulic force transmission structure portion. The first end of the hose can be fluidically connected to the hydraulic force generator, and the second end of the hose can be configured to be reversibly connected to the first hydraulic force transmission structure portion. The hose can also be reversibly connected to the second hydraulic force transmission 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 transmission structure portion. The modularity of the device components means that a single hydraulic force generator can be used to adjust the force applied to the user's skull structure by multiple force transmission structure portions. In this way, the modularity of the device eliminates the need to operate multiple hydraulic force generators, thereby reducing the cost of the system. In the case where the device is required to apply simultaneous and different force characteristics, multiple hydraulic force generators can be used. The hydraulic force generators can be separate units, which can be connected together or arranged in a single housing / single closed unit.

[0026] The above disclosure of the invention is general and not related to applying periodic forces to a specific skull structure. We now turn to some specific applications of the device.

[0027] In some embodiments, the device is configured to perform maxillary or mandibular expansion, which can refer to widening of the dental arch due to tooth movement, or widening due to displacement of bone parts, which can be naturally present, produced by using the device or surgical separation sutures. In this case, the first force and the second force cause the outward bending of the jaw in question, and the expansion of the upper / lower surface of the mouth, even if the mandibular or maxillary bones are not too curved. It is recognized that the structure configured to receive forces (directly or indirectly) from such a device may be subjected 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 can be a tooth. For example, the first anchor and / or the second anchor can include a wire, a band or other orthodontic fixture configured to be wrapped around a tooth, or a plate / wire configured to abut or engage the inner or outer surface of a tooth. In embodiments where the first anchor point and the second anchor point are respectively a first tooth and a second tooth, it is preferred that the first tooth is symmetrically opposite to 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 so as to provide a close fit, thereby more effectively transmitting force. Depending on the shape of the dental arch and the desired clinical outcome, alternative arrangements of anchors may be employed. 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 a location on the soft tissue of the user's mouth. In such embodiments, the first and / or second anchor may include a screw or equivalent fastener configured to directly contact bone or soft tissue. By more directly contacting the tissue, more effective force transmission can be achieved.

[0028] According to an exemplary embodiment, the device can be in the form of an expansion mechanism, or include an expansion mechanism, which can be configured to perform maxillary or mandibular expansion. The expansion mechanism can be configured to be arranged in a roughly central position on the upper surface of the user's oral cavity. The expansion mechanism can include a central component, a hydraulic component, a channel component, and an attachment component. According to an exemplary embodiment, the central component can be adjusted by rotating the threaded portion relative to the channel component so that it applies a constant force to the patient's skull structure through the attachment component. This force defines a background static force. Then, in use, an external hydraulic force generator is used to periodically expand and contract the hydraulic component. When the hydraulic component expands, it applies additional force to the user's skull structure through the attachment component. The additional force can be a periodic force. When this occurs simultaneously, the area of ​​the user's skull structure arranged between the two attachment components is subjected to a tensile force that promotes maxillary expansion.

[0029] The central component can be configured to displace itself relative to the channel component. Alternatively, the central component can be configured to cause separation between the first channel component and the second channel component. The central component can include an elongated member having a threaded portion, which is configured to be accommodated in a threaded hole of the channel component. The elongated member can be configured so that rotation of the threaded portion causes displacement between the central component and the attachment component in a direction parallel to the longitudinal axis of the elongated member. Therefore, the elongated member can be configured to apply a static force on the channel component configured to engage with the threaded portion. The elongated member can include a first and a second threaded portion, which are arranged at opposite ends of the elongated member and are configured to engage with each of the first and second channel components, respectively.

[0030] The central component may also include an alignment rod extending between the first and second channel components, which may be configured to maintain alignment of the channel components as they move relative to each other due to rotation of the threaded portion. The central component may include two or more alignment rods. The first and second alignment rods may be disposed on either side of the elongated member to ensure that the components are properly aligned.

[0031] The alignment rod may be cylindrical (i.e., have a circular cross-section). It should be appreciated that the alignment rod may be configured to have any of a square, rectangular, oval, and hexagonal shape or any other suitable shape. The alignment rod may be configured to have a rounded rectangular cross-section, including, for example, an inverted rounded cross-section.

[0032] The channel component can be configured (i.e., shaped and / or arranged) to accommodate the hydraulic component. The channel component may include one or more holes configured to receive the ends of the alignment rods of the central portion. The hydraulic component may include an expandable structure, such as an airbag. The expandable structure may include an elongated, substantially cylindrical airbag comprising a conical or frustoconical tip at its distal end. The proximal end of the airbag may 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 may be aligned with the outer wall of the channel component, or extend beyond the outer wall.

[0033] The attachment component can be configured to attach the expansion mechanism to the patient's skull structure. Specifically, the attachment can be configured to attach at least one of the channel component and the central component to the skull structure. The attachment component can include a molded structure that is shaped to match the contour of the patient's upper jaw and / or teeth so as to form a close fit therewith. The attachment structure can include a fastening that can be detached from the molded structure so that, for example, a single expansion mechanism can be removably attached to a variety of different molded structures and accessories. The attachment component can include a fastening device that is configured to attach the expansion mechanism directly to the skull structure. The fastening device can include one or more bone screws. In this way, the attachment component can define at least one of the first and second anchors. The screw can include a round or dome-shaped head that is configured not to provide any sharp edges that may damage soft tissue. The top surface of the dome screw can include a hole or recess formed in a hexagonal shape, which can be configured to be able to turn the screw with a hexagonal tool.

[0034] The attachment component may include a wing or foot extending from the body of the attachment component. The wing may include a hole configured to receive a fastening device. The hole may include a positioning slot configured to releasably attach the wing to the screw. The positioning slot may include two intersecting circular holes or holes. The first larger hole may be configured to be larger than the diameter of the screw head. The second smaller hole may 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 may allow the head of the screw to pass through the first hole. The second hole may be configured to receive the shaft of the screw when the attachment component is arranged in the desired portion of the user's mouth. The underside of the dome screw may be configured to engage with the chamfered edge of the second hole of the positioning slot. The wing may be substantially aligned with the base of the body, and the wing may be configured to extend along a plane substantially parallel to the base of the body. The wing may be integrally formed with the body of the attachment component. The attachment component may include a plurality of wings. The wing may be arranged at the distal corner of the body of the attachment component. The attachment component may be integrally formed with the channel component.

[0035] 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 component, the attachment component, and the central component. The cover protects the patient's soft tissue from direct contact with features of the expansion mechanism. For example, the cover can be arranged to prevent the patient's tongue from contacting any movable component of the expansion mechanism. For example, when in use, the hydraulic component can be configured to cause periodic displacement of the movable component, which may cause injury or discomfort to the patient.

[0036] In other similar embodiments, the device can be used for forward expansion of the maxilla or mandible, that is, forward growth of the maxilla or mandible, such as correction of the lower jaw or palate. In embodiments where the device is used for forward expansion of the mandible, the device may 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 force and the second force cause growth and / or displacement and remodeling of the upper / lower surface of the oral cavity and the maxilla / mandible itself in the anterior-posterior direction (anterior-posterior). In these embodiments, the first anchor point may be one or more teeth. In this case, the first anchor may be in the form of a wire, a 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 rear surface of the front teeth. Alternatively, the first anchor may include a molded plate shaped to fit the back of the tooth so as to provide a tight fit, thereby more effectively transmitting force. The second anchor point may be a point on the soft tissue of the upper or lower jaw of the user, which is located behind the first anchor point, and the second anchor point may include a screw or equivalent fastener configured to directly contact the bone, tooth or soft tissue. By more directly contacting the tissue, forces can be transmitted more effectively.

[0037] In the above embodiments, there are two main ways that the force generated by the force generator can be effectively transferred to the first anchor and the second anchor. As described above, the force transfer structure can be in the form of a hydraulic force transfer structure. Alternatively, an approach including solid components configured to convert one type of motion into another type of motion can be used, i.e., without hydraulic components. Throughout this application, this will be referred to as a mechanical force transfer structure. In some embodiments, there can be a mixture of hydraulic and mechanical force transfer structures.

[0038] As described above, it is preferred that the periodic force is maintained in the anterior-posterior direction, or converted into a force in the anterior-posterior direction. However, in order to primarily 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 may include a mechanism for converting the periodic force into a first force at about 90° to the periodic force and a second force at about 90° to the periodic force and opposite in direction to the first force. The force transmission structure preferably includes a first force transmission component, which is arranged to transmit the periodic force from the force generator to the anchor, and the first force transmission component includes one or more of a wire or a piston. Specifically, the force transmission component is configured to transmit force in the form of a linear reciprocating motion, or to periodically oscillate a 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 component. The rotating component may include a first thread. The mechanism may also include a first threaded member having a second thread on at least the proximal end, the second thread being complementary to and engaged with the first thread. The distal end of the first threaded member is preferably in contact with the first anchor. The rotating component and the first threaded member are preferably arranged so that the rotation of the rotating component is converted into a reciprocating linear motion of the first threaded member by the engagement between the first thread and the second thread. Then, the periodic force is transmitted to the first anchor by this reciprocating linear motion. The rotating component may have a third thread opposite to the first thread in meaning, and the mechanism may include a second threaded member having a fourth thread complementary to and engaged with the third thread. The mechanism may also include a second threaded member having a third thread opposite to the second thread in meaning. The distal end of the second threaded member is preferably in contact with the second anchor. The rotating component and the second threaded member are preferably arranged so that the rotation of the rotating component is converted into a reciprocating linear motion of the second threaded member by the engagement between the third thread and the fourth thread. Then, the periodic force is transmitted to the second anchor by this reciprocating linear motion. Alternatively, the same effect can be achieved by providing a first rotating component and a second rotating component. In other embodiments, the mechanism may include one or more worm gears and pinions, or a ball and socket connection, so as to achieve the same effect.

[0039] Other embodiments adopt hydraulic transmission structure, including one or more expandable structures, such as airbags, bellows or other equivalent components. In these embodiments, the force transmission structure preferably includes a channel or chamber containing hydraulic fluid, and a piston configured to move the fluid in the entire channel or chamber, thereby causing the expandable structure to expand or collapse. In some embodiments, there is a first expandable structure rigidly connected to the first anchor (for example, through a first rod or other rigid body) and a second expandable structure rigidly connected to the second anchor (for example, through a second rod or other rigid body). The expandable structures here can be in series (i.e., fluidly connected to each other), or can be independent components, removably or permanently attached to independent rigid bodies. Here, rigid connection should be understood to mean that these two features are connected by an inflexible and / or incompressible connector. The expandable structure can be located in a groove or channel. When the first expandable structure and the second expandable structure expand, the expansion force (i.e., the periodic force transmitted by, for example, the piston) is transmitted to the first anchor and the second anchor respectively. Alternatively, a single expandable structure can be rigidly connected to the first anchor and the second anchor, so that the expansion of the single expandable structure transmits the periodic force to the first anchor and the second anchor. The or each rod may be cylindrical (i.e. have a circular cross section). Alternatively, each rod may comprise a cross section of any of square, rectangular, elliptical and hexagonal or any other suitable shape. The or each rod may be configured to have a circular rectangular cross section.

[0040] Using a hydraulic transfer structure such as that described in the previous paragraph, the direction of the periodic force can be more easily changed by appropriate orientation of the rigid connector and the inflatable structure. For example, the hydraulic transfer structure can be used for maxillary / mandibular expansion, anterior expansion, or maxillary / mandibular extension by appropriate arrangement of the inflatable structure and the rigid connector. In the above, the term "rigid" should be understood to mean that the component such as the connector is incompressible over its length at 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.

[0041] In other embodiments, the inflatable structure may be in direct contact with the first anchor and / or the second anchor. Alternatively, the first anchor and / or the second anchor may be formed by an inflatable structure. For example, the device may include a plurality of inflatable 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 anchor and the second anchor comprise a molded structure or plate, one or more inflatable structures may 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 the one or more inflatable structures may be located on any surface of the molded structure. It is recognized that the molded structure may define a structure configured to conform to a corresponding surface of a patient's oral cavity, such as a portion of the upper jaw and / or an inner surface of a tooth, and / or a bone interface.

[0042] The molded structure can be configured to be fixed to the roof of the user's mouth using a fastening device, such as a bone screw, when in use. In this way, as described above, the fastening device can define at least one of the first and second anchors. At least one molded structure can be configured to engage with the fastening device so as to fix the molded structure to the patient's skull structure. The molded structure can be configured with a hole or opening that is arranged to receive a fastener, such as a bone screw. The opening can be arranged at the edge of the molded structure and configured to be at least partially open on the lateral side. In this way, the opening can enable the molded structure to be slidably engaged with a fastener that is fixedly attached to the patient's skull 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 middle end of the molded structure, which is configured to receive the fastener when it is moved in the middle direction when the molded structure is installed in the patient's mouth.

[0043] The molded structure may include one or more molded plates. According to an exemplary arrangement, the molded structure may include a central molded plate and a peripheral molded plate. Each molded plate may be shaped to conform to a corresponding (i.e., selected) surface of the user's oral cavity, such as a portion of the upper jaw and / or the inner surface of the teeth. An inflatable structure such as an airbag may 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 may define a channel in which the inflatable structure is arranged. The channel may be tapered (i.e., configured so that the width of the channel narrows along the junction between the two molded plates). The tapered channel may narrow from the front to the back of the molded plate. In this way, the tapered channel may be configured to cause a greater expansion of the inflatable structure in the wider portion than in the narrower portion. The greater relative expansion of the inflatable structure may cause the molded structures to rotate relative to each other.

[0044] The inflatable structure may be configured to articulate the joint by expanding and / or contracting with a hydraulic fluid. The inflatable structure may be contracted, or at least only partially expanded, to facilitate access to a fastening device configured to secure the molded structure to the user's mouth. Additionally or alternatively, the inflatable structure may be expanded to make the joint rigid. Thus, expansion of the inflatable structure causes the peripheral molded plate to come into close contact with the surface of the user's mouth to which it is shaped to fit. In this way, the peripheral molded plate may be configured to transmit the force generated by the inflatable structure to the user's mouth. Thus, the peripheral molded plate may define at least one of the first and second anchors, and the inflatable structure may define at least a portion of the hydraulic force transmission structure. By inflating the inflatable structure between the central and peripheral molded plates, the device may be configured to affect maxillary or mandibular expansion of the user's mouth. The passageway of the joint between the central molded plate and the peripheral molded plate may include a substantially straight portion. In use, the straight portion may be arranged at an angle to the midline of the patient's mouth. The joint between the molded plates may include a curved portion, the curvature of which may be configured to at least partially follow the curvature of the tongue plane. Where the apparatus comprises first and second peripheral moulding plates arranged on either side of a central moulding plate, the channels between the respective plates may be arranged such that they are substantially parallel to each other.

[0045] In the above arrangement, it is appreciated that the inflatable structures may be configured to enable relative movement between the central and peripheral moulding plate structures. Each inflatable structure may be formed of a flexible material configured to allow relative displacement of the plates in lateral and / or vertical directions. The enhanced flexibility provided by the inflatable structures means that the peripheral moulding plates may be displaced laterally during use, and may also be rotated relative to the patient's mouth. In this way, the resulting movement of the peripheral plates causes it to conform to the shape of the patient's mouth, thereby reducing discomfort to the patient.

[0046] Furthermore, the combination of the expandable and molded plate structures described above allows the device to accommodate asymmetric expansion of the patient's cranial structure. For example, such a device is able to accommodate external rotation of the hemimaxilla caused by greater posterior resistance from adjacent structures. Furthermore, it also allows the device to accommodate differences in relative expansion of cranial structures (e.g., one hemimaxilla may be rotated more than the other), thereby ensuring that effective force transfer is maintained.

[0047] According to an exemplary embodiment, the first anchor may be defined by a fastening device configured to secure the central molded plate to the user's oral cavity, and the second anchor may be defined by a 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 may include another peripheral molded plate that is arranged on an opposite side of the central molded plate. According to such an arrangement, the first and second peripheral molded plates may define the first and second anchors, respectively, as they may both be configured to transmit opposing forces on opposite sides of the user's oral cavity.

[0048] According to an alternative aspect of the present invention, an expandable structure may be arranged at a joint between two structural elements. At least one structural element may define a slender member configured to extend longitudinally from the joint. The other of the two structural elements may be a molded structure configured to conform to the shape of the patient's skull structure. Alternatively, the first and second structural elements may each include an elongated member. The free end of the elongated member may be attached to the patient's skull structure. In this way, the free end of the elongated member may define at least one of the first and second anchors, as described above. The elongated member may be movably fastened to the other structural element by a bolt fastening device, and the expandable structure may be received by a central hole of the fastening device.

[0049] In a particularly preferred embodiment, the device comprises a molded structure or plate, which is preferably shaped to fit the user's mouth. The molded structure may include a recess shaped to fit the user's teeth. The recess may be arranged on a surface of the molded structure, which surface is arranged to contact at least one of the inner surface, outer surface, buccal surface, labial surface, lingual surface and occlusal surface of the teeth. The molded structure may include a plurality of recesses, each shaped to fit a plurality of teeth of the user. One or more of the plurality of recesses may preferably comprise a cantilever structure.

[0050] It is recognized that the recess can accommodate more than one tooth. The recess can include a cantilever structure that is configured to engage with the user's teeth when the device is in place within the user's mouth. The surface of the cantilever structure can be shaped to contact the surface of the user's teeth. The cantilever structure can be arranged to contact, face, abut or engage any surface of the tooth. For example, the cantilever structure can be configured to contact at least one of the inner surface, outer surface, buccal surface, labial surface, lingual surface, and occlusal surface of the tooth.

[0051] In addition, the device preferably includes a channel or groove, and an inflatable structure housed in the channel, the channel being located directly behind the cantilever structure. The channel can be arranged inside the device so as to define an internal channel. The channel can be arranged in a molded structure of the device. The channel is therefore preferably curved so as to match the curvature of the dental arch. The inflatable structure is preferably arranged so that when it expands, it exerts a force on the cantilever structure, which force acts to cause the cantilever structure to bend. Therefore, in use, when the inflatable structure expands, the force exerted on the cantilever structure is applied to the teeth resting in the recess, and the force acts to cause the teeth to move. In this way, the cantilever structure can define a first anchor and the teeth can define a first anchor point. The second anchor can be defined by a second cantilever structure. Alternatively, the second anchor can be defined by an inflatable structure that is configured to directly contact a skull structure, such as a tooth.

[0052] In an exemplary arrangement, a first cantilever structure can be configured to contact a first tooth surface and a second cantilever structure can be configured to contact a second tooth surface. The first and second tooth surfaces can each define an inner surface or an outer surface of a tooth. For example, the first and second cantilever structures can be configured to contact two different surface portions of a tooth. The first and second cantilever structures can be configured to apply a separate force to each of the first and second surface portions of the tooth. The second cantilever structure can 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 can be operated to achieve greater control over the forces applied by the cantilever structures on the tooth. For example, the first cantilever structure can be configured to apply a first force and the second cantilever force can be configured to apply a second force, wherein the first force and the second force include different magnitudes and directions. The first and second cantilever can be configured to apply uneven forces on the tooth, causing translation and / or rotation of the tooth.

[0053] The first inflatable structure may be configured to exert a force on the first cantilever structure, and the second inflatable structure may be configured to exert a force on the second cantilever structure. In this way, the expansion of the first and second inflatable structures may be controlled to determine the respective forces exerted by the first and second cantilevers.

[0054] The cantilever structure may define an elongated cantilever finger including a first end attached to the molded structure and an unattached second end. The unattached end may be movable relative to the molded structure to enable the cantilever finger to flex. It should be appreciated that the cantilever structure may define any structure including 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 toward the free end.

[0055] The recess can be arranged to be in close contact with the tooth surface, or at a certain distance from the tooth surface and in a different orientation, such as tilted at an angle. In addition, the recess includes more than one part, and in one embodiment, the first part can be arranged at a first position of the tooth close to the gum line, and the second part can be arranged at a second position substantially away from the gum line. A single cantilever structure can be accommodated in the first and second parts of the recess. The first and second parts of the recess can be interconnected. In some embodiments, there can be more than one cantilever finger. Each of these parts can naturally be molded to one or more teeth at slightly or substantially different angles. Alternatively, each part can be designed so that they are placed at substantially different angles, for example, the cantilever fingers can be individually oriented and act in an upward or downward inclined plane passing through the local longitudinal axis of the airbag (relative to its adjacent parts or vertical axis).

[0056] The area of ​​each portion comprising the cantilevered fingers may vary, for example, a thicker cantilevered finger will bend less when subjected to a force than a thinner finger. Reduced bending of the fingers may allow less force to be transmitted to one or more teeth with which it is paired, thereby allowing different finger thicknesses throughout the device to apply different forces to the teeth when a single expandable structure is employed. The fingers and / or their adjacent portions may be made of materials of varying hardness. In addition, there may be one, more than one, or no fingers in contact with a tooth or group of teeth. There may be a single or multiple internal channels, the latter accommodating multiple expandable structures.

[0057] The following characteristics may also vary depending on the cantilever structure:

[0058] The application plane, i.e. the angle of the cantilever structure

[0059] The area where the force is applied, i.e. the top of the tooth, the middle of the tooth, or along the gum edge

[0060] Length and number of fingers on each tooth

[0061] Fingers / hardness of different materials

[0062] Multiple airbags connected in series or parallel.

[0063] Furthermore, the tunnel / groove / channel may be continuous or discontinuous in the midline. The tunnel shape, circumference, length, and route may vary. The device may contain multiple tunnels or channels, with multiple air cells. The channel may be partially or completely divided to accommodate one or more air cells.

[0064] The internal passageway may also vary in a variety of ways, such as its course, length, circumference, continuity, i.e. whether it communicates through a gap between two parts, etc.

[0065] It is also obvious that by varying the characteristics of the above-mentioned components, one or some teeth may be completely or relatively free from the application of forces.

[0066] In an embodiment, the cantilever structure can be defined as an intermediate structure disposed between the expandable structure and the patient's cranial structure. Alternative intermediate structures may include a sliding member or a scoop-shaped member. Where the intermediate structure includes a scoop-shaped member, the scoop-shaped member may include a scoop-shaped portion defining a recess of the molded structure that is shaped to conform to the tooth surface.

[0067] The intermediate structure may be defined by a weakened portion of a tooth-facing surface or wall of a recess of the molded structure. Thus, the tooth-facing wall of the recess may include an area that is scored or punctured so as to reduce its rigidity relative to the surrounding recess wall. The weakened surface portion may be defined by two or more cantilever fingers extending through holes in the recess wall. Each cantilever finger may be connected to another cantilever finger so as to form a flexible grid arrangement. The grid of cantilever fingers may define a cross-shaped arrangement.

[0068] For example, each of these alternative intermediate structures can be configured to receive force from the inflatable structure and transmit the force to the teeth. In use, when the inflatable structure inflates and expands outward, its outer surface can exert 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.

[0069] It will be appreciated that the intermediate structure may further define any recessed portion 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 when in use, and may be configured to transmit forces therebetween. Such an intermediate structure may be desirably configured to contact any surface of the tooth that may be manipulated to effect tooth displacement. For example, the intermediate structure may be configured to contact at least one of an inner surface, an outer surface, and an occlusal surface of a user's tooth.

[0070] In the above embodiments, preferably, the first anchor, the second anchor, at least a portion of the force transfer structure (preferably, a mechanism for converting a periodic force into a first force at about 90° to the periodic force and a second force at about 90° to the periodic force and in the opposite direction to the first force or the inflatable structure) are sized to fit within the oral cavity of the user. Such a device may be referred to as an intraoral appliance because, during use, the majority of the device is located within the oral cavity of the user. This is advantageous because it allows for a more compact device. It should also be accepted that any combination of air cell arrangements are covered within the oral cavity, such as opposing air cells on either side of the teeth, contacting a set of teeth, whereby their expansion causes the teeth to retract, and air cells located, for example, above the gums of the maxillary bone. The same principles apply to the skull. In embodiments where the device includes a hydraulic force transfer structure, the change in direction of the force may be determined by the shape of the inflatable structure used.

[0071] In some embodiments, the device may include a molding plate shaped to fit the surface of the user's teeth. In some embodiments, it is preferred that the molding plate fits flush with the surface of the user's teeth to ensure maximum transmission of force.

[0072] The molding plate can be formed to fit 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 wrapped. When force is applied to the inner surface of the tilted tooth, the outer part of the molding plate acts as a "rotation stopper" to limit the further tilting and final uprighting of the tooth. When used on a tooth that is already in the correct plane, i.e., not tilted, the device can achieve translation. By minimizing the distance between the outer wall of the molding plate and the outer surface of the tooth, the device can adapt to the tilting and uprighting of the tooth, i.e., the movement and tilting of the tooth can occur until the tooth contacts the wall, and then uprighting occurs. At this point, if further expansion is required, another device can be molded. It should also be understood that one or more recesses can have these features to a smaller or greater extent, or not have a larger wall height adjacent to the outer surface of the tooth or no cantilever fingers at all. The reverse arrangement can also be used to "push" the tooth "inwardly".

[0073] However, in some embodiments, if the molding plate is shaped to fit the teeth only at the upper part of the teeth, 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 teeth, an additional effect of preventing or correcting tooth tilting can be achieved. Alternatively, the molding plate can be shaped to fit the teeth only at the lower part of the teeth, 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 teeth. In this way, when the device is used to achieve maxillary expansion, for example, the outward force is applied to, for example, the lower part of the tooth only after some movement of the upper part of the tooth, for example to correct the tilt of the tooth.

[0074] In other words, the molding plate can be shaped to conform to the inner surface, the uppermost portion (apex), and a portion of the outer surface of the tooth. In this way, the tooth is partially encapsulated. When force is applied to the inner surface of the tilted tooth, the outer portion of the molding plate acts as a rotation stop, limiting further tilting and eventual straightening of the tooth.

[0075] When used on teeth that are already in the correct plane, the device can achieve translation, ie by limiting or preventing any rotational movement without tilting.

[0076] At this point, if further expansion is desired, another device can be molded. It will also be appreciated that one or more of the recesses may have these features to a lesser extent, a greater extent, or entirely without, for example, a greater wall height adjacent the outer surface of the tooth or without cantilever fingers. The reverse arrangement may also be used to push the tooth medially or inwardly, i.e., toward the center of the oral cavity. An illustrative diagram relating to the geometry of the cantilever structure is provided in Fig.37 Shown in.

[0077] In the above-described embodiments, the skull structure being reconstructed is located between a first anchor point and a second anchor point. However, the core principles of the invention are equally applicable to situations where the skull structure to be changed is not located between two anchor points. Therefore, a second aspect of the invention provides a device for skull reconstruction by expansion, 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 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 transfer structure connected to the force generator and configured to transfer the periodic force to the first anchor in a reconstruction direction; wherein the head support comprises: a limiting device configured to prevent or limit movement of the user's head in the reconstruction direction when the periodic force is applied in use. In a very simple arrangement, the second aspect of the invention can be implemented by an arrangement in which the force generator is connected to one or more bone screws via a force transfer structure, the bone screws being located in, for example, the side wall of the maxilla via one or more wires and applying an oscillating force. In this case, as discussed in more detail below, the restraining means may be in the form of friction providing means, or simply the weight of the user's head, which prevents the head from oscillating due to its inertial mass. A securing strap may also be used to stabilize the head.

[0078] Where compatible, the optional features described above with reference to the first aspect of the invention may be equally well applied to the second aspect of the invention and are not repeated here for the sake of brevity. In these embodiments, the head support includes a limiting device that prevents the periodic force from causing only displacement of the user's entire head or the device. In other words, the limiting device receives at least a component of the reaction to the periodic force. Examples of limiting devices will be discussed in more detail later. The device of the second aspect of the invention is particularly useful for maxillary protrusion.

[0079] The device can take the form of a support 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 that forces are applied to the side surfaces of the user's head and face. This means that when a forward and backward force is applied, the friction between the user's head and the inner surface of the head support acts to prevent the user's head from moving forward and backward. When a lateral force is applied, the rigidity of the structure and its fixing mechanism also help to resist 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 restraining device. More generally, it can be said that the restraining device is configured to limit or prevent movement of the user's head by friction. In order to be effective, the friction 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.

[0080] Alternatively, the restraining means may comprise 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 restraining means.

[0081] The track is preferably connected to the head support via one or more connectors. In such an embodiment, the force generator can be in the form of a motor connected to the head support and the proximal end of the connector. Alternatively, the force generator can be in the form of a hydraulic pump, also connected to the proximal end of the connector. In some embodiments, there can 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 can form part of a force transfer structure, which can further include one or more additional connectors, such as a third connector, the proximal end of which is preferably attached to the track, and the distal end of which includes a first anchor, as discussed earlier in this application, which is configured to attach to a first anchor point. The first anchor point can be in the form of a tooth, a maxilla, a mandible, a portion of an occlusal surface, a zygomatic bone, an upper portion of a skull, a nose, or other structure.

[0082] For symmetrical protrusion, the device preferably includes a second anchor for connecting to a second anchor point of a skull structure. The device may also include a fourth connector including the second anchor at its distal end. The second anchor point may be any of the same skull structures listed for the first anchor point in the previous paragraph.

[0083] In some embodiments, the device may include multiple tracks so that advancement of more than one cranial structure may be achieved simultaneously. There is preferably at least one and preferably a pair of force generators associated with each of the multiple tracks, connected to the tracks via connectors.

[0084] In some embodiments, the height of the track can be changed. The "height" mentioned here refers to the degree in the up-down direction. In this way, one device can be used to achieve the reconstruction of different skull structures without having to use completely different devices. To achieve this, one or more connectors can be rotatably attached to the head support so that the assembly including one or more connectors and the track can be rotated to the desired position for skull reconstruction. Alternatively, the assembly including at least a connector and a track, preferably also including one or more force generators, can be translated in the up-down direction, for example on a dedicated structure. In some embodiments, the track can be mounted on an assembly on which the track can rotate and translate to allow greater flexibility of movement.

[0085] In some embodiments, the restraining device may be located on a track. Preferably, the restraining device is movable along the track so that it can be located in the best position for the particular skull reconstruction being performed. There may be multiple restraining devices, for example to ensure symmetrical operation.

[0086] The present invention also encompasses devices that can be used for skull compression. Although 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 skull structures. 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 transfer structure configured to transfer the periodic force to the user's skull.

[0087] In some embodiments of the third aspect of the present invention, the head support comprises or is in the form of a helmet, the inner surface of the helmet being shaped or molded to fit the outer surface of the user's head. By molding the helmet to fit closely to the shape of the user's head, it is possible to ensure a tight fit, which in use will apply pressure roughly equally in all directions on the user's skull. Regions may be omitted to limit force application to specific regions of the head. Embodiments of the third aspect of the present invention may be used to correct specific skull deformities, which will require compressive forces to be applied in specific directions on specific parts of the user's skull. Benefits may also be obtained by acting on soft tissue structures. Therefore, it is highly preferred that the head support comprises a first portion positioned to cover the skull structure in question, and a second portion positioned opposite or substantially opposite to the skull structure in question. Here, "opposite" should be understood as the first and second portions being located on opposite sides of the user's skull in use. This ensures that when a compressive force is applied by the first portion to the skull structure in question, the second portion is able to provide the required reaction force to maximize the effect of the compressive force.

[0088] In some embodiments, rather than the head support being in the form of a molded helmet, the head support may include a first portion and a second portion that are movable relative to each other, and a device for connecting the first portion to the second portion in a manner where the inner surfaces of the first portion and the second portion are configured to apply a compressive force on the user's skull. In some embodiments, the first portion and the second portion may be connected to each other at a hinge. The first portion and / or the second portion may then include a locking device for securing the first portion and the second portion in an area opposite the hinge. For example, the first portion may be shaped to accommodate the back of the user's head so that the user can lie headfirst in the first portion. The hinge may be located in an area corresponding to the top of the user's head so that once the user places their head in the appropriate position in the first portion, the second portion may be lowered (i.e., pivoted about the hinge) above their head and connected to the second portion by a suitable locking device.

[0089] In other embodiments, the head support may further include a third portion, with the second and third portions being connected to the first portion by a hinge. Similar to the embodiments described in the previous section, the first portion may be shaped to accommodate the back of the user's head so that the user can lie headfirst in the first portion. The hinge may be located in an area corresponding to the left and right sides of the user's head so that once the user places their head in the appropriate position in the first portion, the second and third portions may rise around the sides of the user's head and be secured to each other by suitable locking devices. This may be used, for example, for lateral compression of the user's skull. These embodiments may also easily employ hydraulic elements to actuate other components, as well as apply force directly to the anchor point, for example by including an expandable structure on the surface of the structure that contacts the skull.

[0090] As with the force transmission structure of the previous aspect of the invention, the force transmission structure of the third aspect of the invention is preferably a hydraulic force transmission structure. It preferably includes one or more inflatable structures, such as air bags or bellows, which are located on the inner surface of the head support at positions corresponding to the skull structure in question. The force generator is preferably configured to periodically inflate and deflate the inflatable structure so as to superimpose the periodic force on the static compressive force applied by the head support.

[0091] The first three aspects of the present invention focus on the periodicity of force. However, the inventors have noted that advantageous effects can be provided by means of a device capable of applying any force (e.g., a constant force, a continuous force, a decaying force, or a periodic force as defined earlier in this application) using a hydraulic force transfer structure. The use of a hydraulic force transfer structure results in a more efficient and more easily controllable transfer of force from the force generator to the cranial structure. The following aspects of the present invention focus on devices that use a hydraulic force transfer structure to transfer a general force, whether the force is constant or otherwise. It should also be understood that all aspects, including electromechanical variations, can be used to produce a constant force as well as a continuous rate of displacement, i.e., a constant rate.

[0092] Therefore, a fourth aspect of the present invention provides a device for skull reconstruction by expansion, compression or bending of a skull structure between a first anchor point and a second anchor point, the device comprising:

[0093] a force generator configured to generate a force;

[0094] a first anchor for attachment to a first anchor point;

[0095] a second anchor for attachment to a second anchor point;

[0096] A hydraulic force transmitting structure is connected to the force generator and is configured to transmit a periodic force to the first anchor and the second anchor to place the skull structure in at least one of tension, compression, or flexion.

[0097] A fifth aspect of the present invention provides a device for performing skull reconstruction by expansion, 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 portion of a user's head; a force generator configured to generate force; a first anchor for attaching to the first anchor point; a hydraulic force transmission structure connected to the force generator and configured to transmit a periodic force to the first anchor in a reconstruction direction; wherein the head support comprises: a limiting device configured to prevent or limit movement of the user's head in the reconstruction direction when the periodic force is applied during use.

[0098] A sixth 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 force; and a hydraulic force transmission structure configured to transmit periodic force to the user's skull.

[0099] Those skilled in the art will appreciate that the optional features described above in this section for the first, second and third aspects of the invention may also be applied to the fourth, fifth and sixth aspects of the invention. The skilled person will particularly note that the optional features of the first aspect of the invention are particularly (but not exclusively) applicable to the fourth aspect of the invention, the optional features of the second aspect of the invention are particularly (but not exclusively) applicable to the fifth aspect of the invention, and the optional features of the third aspect of the invention are particularly (but not exclusively) applicable to the sixth aspect of the invention.

[0100] The device according to the present invention can be made entirely of MRI safe materials, such as polymers and / or non-magnetic materials. In this way, the device can be used by a user who is undergoing an MRI scan at the same time.

[0101] It should be noted that in some cases, more than one device according to any embodiment of any aspect of the present invention may be used in conjunction with each other to provide skull reconstruction. For example, stretching the maxilla using an embodiment of any of the first and fourth aspects of the present invention may be performed in the same procedure as skull compression. The devices of the present invention are preferably programmable to work synchronously and / or simultaneously. BRIEF DESCRIPTION OF THE DRAWINGS

[0102] The present invention will now be described with reference to the accompanying drawings, in which:

[0103] - Figure 1A and 1B An example of a device for maxillary expansion is shown.

[0104] - Figure 2A and 2B Examples of alternative devices for maxillary expansion are shown.

[0105] - Figure 3 An example of another alternative device for maxillary expansion is shown.

[0106] - Figure 4 An example of another alternative device for maxillary expansion is shown.

[0107] - Figure 5 An example of a similar device for mandibular expansion is shown.

[0108] - Fig. 6A and Figure 6B Examples of alternative devices for maxillary expansion are shown.

[0109] - Fig. 7A , 7B and 7B show examples of alternative devices for maxillary expansion.

[0110] - Fig. 8A and 8B Alternative devices for maxillary expansion are shown.

[0111] - Figure 8C A variety of options for various components of the maxillary expansion device are shown.

[0112] - Fig. 9 An example of a device for anterior maxillary expansion is shown.

[0113] - Fig.10 An example of a device for anterior maxillary expansion is shown.

[0114] - Fig.11 An example of a device for maxillary expansion is shown, comprising two molding plates and a plurality of balloons.

[0115] - Fig. 12A and 12B An alternative device for maxillary expansion using multiple balloons is shown.

[0116] - Fig. 12C and 12D An alternative device for maxillary expansion is shown, comprising a recess containing cantilevered fingers and an elongated balloon.

[0117] - Figures 12E to 12H Four further examples of devices for reconstructing the occlusal surface are shown.

[0118] - Fig.12I It is shown that in e.g. Figures 12F to 12H A close-up of the depression found in the device.

[0119] - Fig.12J and 12KCross-sections of alternative devices for maxillary expansion are shown separately, including an expandable structure and a sliding member.

[0120] - Figure 12L Shown is a cross section of an alternative device for maxillary expansion, including an expandable structure and a scoop-shaped member.

[0121] - Fig.13A Examples of devices that may be used to achieve maxillary expansion are shown.

[0122] - Fig. 13B Shows that it can be Fig.13A An air bag used in conjunction with the device.

[0123] - Fig.14A A device that can be used to separate the skull is shown.

[0124] - Fig. 14B Shown is a close-up view of an expansion mechanism that may be used in various embodiments of the present invention.

[0125] - Fig.15A and 15B Shown are views of alternative expansion mechanisms that may be used with various embodiments of the present invention.

[0126] - Figures 15C to 15E A slotted screw hole arrangement is shown.

[0127] - Figures 16A to 16D Examples of devices that can be used to expand the maxilla, minimize or reverse the effects of tooth tilting are shown.

[0128] - Figures 17A to 17C Various ways of mounting the device according to the invention on the body of a user are shown.

[0129] - Fig.18 An example of a device that can be used for maxillary advancement is shown.

[0130] - Fig.19 It shows that it can be Fig.18 An example of a crossbar structure used in an apparatus.

[0131] - Fig. 20A and 20B Shows the available Fig.18 An alternative crossbar structure in the device.

[0132] - Fig.21 Examples of alternative devices that may be used for maxillary advancement are shown.

[0133] - Fig.22A It shows that it can be used as Fig.21 An example of a hydraulic crossbar structure for the device shown.

[0134] - Fig. 22B and 22C Shows Fig.22A A close-up view of the components in the crossbar structure.

[0135] - Fig.23 An alternative device that can be used for maxillary advancement is shown, in which there are two horizontal attachment points on the skull.

[0136] - Fig.24 Alternative devices that may be used for maxillary advancement are shown.

[0137] - Figures 25A to 25C Schematic diagram showing the device for force delivery to the zygomatic bone.

[0138] - Figures 25D to 25F is a schematic diagram showing placement of the device between the zygomatic bone and the maxilla.

[0139] - Fig.26 Alternative devices that may be used for maxillary advancement are shown.

[0140] - Fig.27A and 27B An adjustable device is shown where the attachment point is the nasal bone.

[0141] - Fig.28 An adjustable device is shown where the attachment point is an intranasal structure.

[0142] - Figures 29 to 32B show an arrangement comprising multiple tracks that can be used for various types of skull reconstruction.

[0143] - Fig.33A and 33B A helmet device that can be used for skull compression is shown.

[0144] - Figures 34A to 34E Examples of arrangements in which a user may position their head to receive compression or other types of skull remodeling from an external device are shown.

[0145] - Fig.35 Alternative devices that can be used for skull compression in the superior and inferior directions are shown.

[0146] - Fig.36A and 36B Instructions on how to use Fig.35 Schematic diagram of the device.

[0147] - Fig.37 A number of different geometries of cantilevered fingers in recesses are shown.

[0148] - Fig.38A and 38B A Matthew-Tesser retractor is shown that may be used in conjunction with embodiments of the present invention. DETAILED DESCRIPTION

[0149] Figure 1A and 1B An embodiment 100 of the device of the present invention is shown, which can be used to widen the maxilla 102 (shown inverted in these figures), but it can equally well be used to widen the mandible. The device includes an extraoral force generator 104 connected to an intraoral portion 106 by a connecting rod 108. The force generator 104 may include a motor (not shown). The intraoral portion 106 includes a central portion 110 having two threads 112, 114 and a central ball socket 116. The distal end 108d of the connecting rod 108 includes a screwdriver portion 109 configured to rotate the central ball socket 116. The intraoral 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 connected to first and second rings 122a, 122b, respectively, which themselves securely surround the teeth 124a, 124b. Similarly, the invisible arm 120a and the second arm are connected to the third and fourth rings 126a, 126b, respectively, which firmly surround the teeth 128a, 128b. In operation, the oscillating rotation of the motor in the extraoral force generator 104 causes the distal end 108d of the connecting rod 108 to rotate, so that the screwdriver portion 109 causes the central ball socket 116 to rotate in an oscillating manner. This oscillating motion in turn generates lateral forces on the threads 112, 114, which are transmitted to the laterally extending arms 118a, 118b, 120a and the invisible second arm, and the rings 122a, 122b, 126a, 126b exert periodic lateral outward forces on the teeth 124a, 124b, 128a, 128b. This lateral outward force can displace teeth and / or widen the maxilla. Figure 2A and 2B The device 500 shown is basically the same as Figure 1A and 1B The device 100 shown is identical except that there are two rods 508, 511, allowing independent force transfer to the teeth 524a, 524b and 528a, 528b. Figure 1A and 1B Reference numerals used in the same manner as those used herein denote Figure 2A and 2B Similar features in FIG. 114. Useful effects may also be obtained as a result of continuous rotation rather than oscillating rotation. For example, the device may rotate 90 degrees in 12 hours. The rate of rotation may be variable. The device may also be used to generate an inward force, slightly rearranging the center mechanism (e.g., reversing the direction of threads 112, 114 or reversing the actuation direction). Such rearrangement is well within the purview of the skilled person.

[0150] Figure 3An alternative embodiment 200 is shown in which the cyclic force is transmitted hydraulically. The device 200 includes two tubes 202, 204, each connected to an intraoral portion 206. Figure 1A and 1B As shown, the intraoral portion 206 includes two pairs of laterally extending arms 208a, 208b, 210a, 210b. The arms 208a, 208b are connected to first and second rings 212a, 212b, respectively, which themselves securely surround teeth 214a, 214b. Similarly, the arms 210a, 210b are connected to third and fourth rings 216a, 216b, respectively, which securely surround teeth 218a, 218b. Although Figure 3 202,204 is not shown, but the tubes 202,204 are connected to the force generator at their proximal ends 202p,204p, which may include a pump. Specifically, the tubes 202,204 may contain hydraulic fluid so that the action of the pump causes the fluid to move back and forth in the tubes 202,204. In some embodiments, the pump may be a manual pump with an indicator (visual, auditory, tactile or a combination thereof) that informs 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 in the tubes 202,204 is converted into a lateral outward force on the lateral extension arms 208a, 208b, 210a, 210b and the rings 212a, 212b, 216a, 216b to apply a periodic lateral outward force on the teeth 214a, 214b, 218a, 218b. This lateral, 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 Figure 2, except that in this case, the device 300 is not anchored to the teeth, but is mounted to the bone of the roof of the mouth through the soft tissue covering the roof of the mouth. In alternative embodiments, the device can also be anchored to the walls of the mouth and / or teeth.

[0151] Figure 5 Shows something like Figure 1A and 1B The device shown here is shown, except that it is shown here on the mandible rather than the maxilla. The internal passage can pass through the midline, for example in the form of a flexible connection, or each part can have its own internal passage. Those skilled in the art will understand that Figure 1A and 1B The description of applies equally well here. In addition, it is understood that Figures 2A to 4 The device can also be directly modified for use in the mandible instead of the maxilla.

[0152] Fig. 6AAn 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 fit the user's palate. The molded plate 602 includes a plurality of recesses 604 around its perimeter, each recess 604 being shaped to fit the surface of a corresponding tooth. Fig. 6A In the device 600, there is also an optional structure 606 which is shaped to wrap around the outer surface of the tooth. The portions of the device arranged to contact the user's teeth each include an airbag, through which force can be transmitted to the tooth through the hole in the recess between the airbag and the tooth surface. Specifically, the force transmitter in this example is hydraulic. Fig. 6A In the embodiment, an additional portion is provided for anchoring to the user's teeth. Figure 6B The device 600' is similar to Fig. 6A The device 600 of the present invention is shown in FIG. 600 , where like reference numerals denote like features. Figure 6B , the device 600' also includes two holes 608', which are positioned to receive screws 610' fixed to the user's palate. The device 600' also includes a slot 612', which is shaped to accommodate a screw (not shown) in the user's palate wall. Those skilled in the art will understand that Fig. 6A and Figure 6B The embodiments can be combined and all features shown are optional.

[0153] Fig. 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 mechanism 704, 754, 764, 804 of each device is as shown in reference Figure 8B As shown and described in detail (see below). Fig. 7A , 7B , 7C and 8A apply force to different areas in the mouth:

[0154] -exist Fig. 7A In the device 700 of , force is applied through two plates 702a, 702b, which are molded to fit the inner surface of the palate. This ensures an even distribution of force across the palate, thereby ensuring even expansion.

[0155] -exist Figure 7B In the device 750, there are two molding plates 752a, 752b. Figure 7B The device 750 and Fig. 7AThe device 700 of FIG. 1 is different in that one of the molding plates 702a is replaced by a molding plate 752a which is shaped to conform to the inner edges 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 molding plate may also include a portion shaped to conform to the inner surface of the teeth near the gum line. Such molding plates are not specific to Figure 7B The embodiment shown is not limited to the embodiment shown, but may exist in any compatible embodiment. In the embodiment shown, the molded plate contacts four teeth, but those skilled in the art understand that embodiments of the present invention are not necessarily limited to contacting four teeth; other numbers of teeth, such as one, two, three, five or six, may be envisioned.

[0156] -exist Figure 7C In the device 760, there are two molding plates 762a and 762b. Figure 7C The device 760 and Fig. 7A The device 700 of FIG. 1 is different in that the expansion mechanism 764 does not include threads. The expansion mechanism includes a pair of elongated alignment rods 766 extending between two hydraulically actuated components.

[0157] -exist Fig. 8A In the device 800, there is only a single molding plate 802b. The other molding plate is completely replaced by a wire structure 806, wherein 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 embodiment shown, the wire contacts three teeth, but those skilled in the art understand that embodiments of the present invention are not necessarily limited to contacting three teeth; other numbers of teeth, such as one, two, four, five, or six, are contemplated.

[0158] Figure 8B Shows the available Figures 7A to 8A Close-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 using the holes 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 part of the mouth against which the other component rests represents the second anchor point, and the force generated causes the jaw located between these areas to be stretched. To some extent, the dental arch is also bent, which also has the effect of widening the jaw. Figure 8C Various examples are shown that demonstrate the modularity of the present invention.

[0159] Fig. 9 and Fig.10 The embodiment shown is 7A to 8A The embodiment shown is somewhat similar except that the device is oriented in an anterior-posterior direction on the palate to achieve expansion of the premaxilla. Fig. 9 and10 In the configuration shown, the central mechanism is secured to the upper surface of the oral cavity (the maxilla is shown inverted) by, for example, bone screws, although other fasteners are equally suitable. Figure 8B The mechanism shown is the same or substantially the same, with the background static force being generated by the screw and an additional periodic component being applied hydraulically. Fig. 9 and Fig.10 In the embodiment of the present invention, the portion of the palate to which the bone screw is attached forms, for example, a first anchor point, and the bone screw forms a first anchor. Fig. 9 and Fig.10 , although in both cases, a molded plate is used:

[0160] -exist Fig. 9 In the , the second anchor is in the form of a molded plate whose front edge is shaped to fit against the back side of the front teeth. A portion of the molded plate is also shaped to also fit against the surface of the palate. This ensures that the forces are evenly transferred to the teeth and jaws to achieve uniform maxillary expansion.

[0161] -exist Fig.10 In the embodiment, the molding plate does not contact the teeth, but only the soft tissue of the upper palate, in which the bone screws can be located (not shown).

[0162] exist Fig. 9 and 10 In the embodiment shown, it will be clear to those skilled in the art that the lateral extent of the moulding plate may vary and the front edge may, for example, contact a number of teeth other than four, such as one, two, three, five or six.

[0163] Figures 11 to 12B An embodiment of the invention is shown which comprises a single moulding plate having a central slot containing a central expansion mechanism, each shaped to fit the palate, with the central expansion mechanism located between them. Alternatively, a similar effect may be achieved using two separate plates. The outer edge of the moulding plate comprises a series of recesses whose positions correspond to the positions of the user's teeth. The device also comprises a series of air cells configured to fit between the recesses and the user's teeth such that expansion of the air cells causes pressure to be applied to the user's teeth.

[0164] Fig. 12C and 12D An embodiment of the invention is shown which comprises a single moulding plate having a central slot containing a central expansion mechanism, each shaped to fit the palate, with the central expansion mechanism located between them. Alternatively, a similar effect may be achieved using two separate plates. The outer edge of the moulding plate comprises a series of recesses, the positions of which correspond to the positions of the user's teeth. The device also comprises a groove or channel in which an elongated inflatable structure is housed, the outer surface of the inflatable structure being in contact with the inner surface of a cantilever structure in the form of a cantilever finger.

[0165] The cantilever structure is arranged so 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 is inflated and expands outward, its outer surface exerts 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 the teeth to shift, and when multiple teeth move, the dental arch expands (i.e., the maxillary expansion). In this way, the inflatable structure is configured to push the cantilever structure between an unbiased configuration (i.e., the cantilever is housed in the molded structure) and a biased configuration, in which the cantilever structure extends forward from the tooth-facing surface of the recess. In this way, the cantilever structure defines an intermediate structure arranged between the inflatable structure and the teeth.

[0166] In an alternative arrangement, the cantilever structure may be arranged to extend from the tooth-facing surface of the recess even when no force is applied by the expandable structure. Thus, when the molding plate is installed in the patient's mouth (i.e., such that the tooth-facing surface of the recess is in contact with the teeth), the corresponding teeth exert a force on the outer surface of the cantilever structure, thereby biasing it toward the expandable structure. The expandable structure may be configured to resist the resultant force exerted thereon by the cantilever structure.

[0167] exist Figures 11 to 12D In the embodiment shown, the inflatable structure may comprise a plurality of balloons in fluid communication with each other (advantageous as they can all be inflated from a single source), but alternatively other embodiments may comprise a plurality of balloon bands. The balloons may be independently inflatable to impart a greater degree of control. A static (i.e. 'background') force may then be applied by adjusting a screw in the central mechanism, thereby applying a constant outward force to the inner surface of the tooth via the balloons. In use, the balloons may then be cyclically inflated / contracted to provide a periodic component superimposed on the static component provided by the moulding plate, thereby applying a non-zero force which is always positive to the tooth to effect maxillary expansion. Alternatively, the non-zero force may be produced by balloon expansion, with further pulsation imparting the periodic component. Note that in Figures 11 to 12B In the illustrated embodiment, the balloon is shown on only one side of the device, but it will be apparent to one skilled in the art that the balloon can be in place on both sides. For example, there can be a single molded plate, and the opposite sides of the central mechanism can be fastened using bone screws or other suitable fasteners along, for example Fig. 9 and 10 Alternatively, as Figures 7A to 8A As shown, a molded plate with an expandable structure on one side can be combined with an alternative anchor structure on the other side, such as molded directly onto the tooth, 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.

[0168] Figures 12E to 12GAn embodiment is shown that is designed to promote remodeling by acting at the occlusal plane, which may be defined as an imaginary plane between the upper and lower dental arches. Figures 12E to 12G The device consists of a continuous U-shaped airbag connected to a hydraulic line, which the user bites down during use. The cyclic expansion / contraction of the airbag then generates a force applied to the user's teeth. A feedback system can be used to indicate how hard the user should bite down. Fig.12F In the embodiment of the present invention, the expandable bite plate is mounted to a portion molded to fit the teeth of the lower dental arch. It will be appreciated that the reverse or other arrangements are possible. Figure 12G In the device, there 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 exit the device, wherein the tubes are contained within the device and exit the front of the device. According to an exemplary alternative arrangement, the airbags are arranged within a guide element, which is configured to prevent the airbags from opening or expanding in a lateral direction when the airbags are compressed between the teeth and the bite plate. The guide element includes a groove or channel with rigid side walls. The channel has an open bottom surface so that when in use, the airbags can directly contact the occlusal surfaces of the teeth. In this way, the rigid walls ensure that the airbags expand in a substantially vertical direction, thereby increasing the force applied to the teeth. Similarly, other arrangements are possible.

[0169] exist Fig.12H and 12I In the invention, cantilever fingers are arranged at the bottom of a depression along the occlusal surface. The depression is molded into part or all of the crown of the tooth. When the expandable structure below the finger expands, the cantilever finger is displaced upward or at an upward angle, that is, upward but can be tilted. This action provides force to the uppermost path of the tooth and the alveolar bone.

[0170] Fig.12J and 12K A cross section of an alternative device for maxillary expansion is shown, comprising an expandable structure and a sliding member. The sliding member defines an intermediate structure disposed between the expandable structure and the teeth.

[0171] The sliding member is housed in the molded structure of the device in a manner similar to the cantilever structure described above. The device includes a groove or channel in which an elongated inflatable structure is housed, and the outer surface of the inflatable structure is arranged to contact the inner surface of the sliding member. The elongated sliding member is housed in a corresponding channel, which extends in a direction substantially perpendicular to the longitudinal direction of the elongated inflatable structure. In use, when the inflatable structure is inflated and expands outwardly, its outer surface exerts pressure on the inner surface of the sliding member, causing it to press on the tooth surface, thereby causing the teeth to shift, and when multiple teeth are moved - the dental arch expands (i.e., maxillary expansion). The sliding member is Fig.12J, shown in the unbiased configuration (i.e., the stowed position within the molded structure), Figure 12K is shown in a biased position, with the sliding member protruding from the tooth-facing wall of the recess.

[0172] The sliding member includes a locking portion that is wider than the rest of the sliding member. The locking portion is received in a corresponding portion of the channel and is configured to limit the travel of the sliding member along the channel. A spring is disposed between the locking portion of the sliding member and an inner wall of the locking portion of the channel. The spring is configured to prevent the sliding member from protruding from its channel. Fig.12J and 12K As shown, when viewed from a longitudinal section, the locking portion of the sliding member may include a substantially square profile. Alternatively, when viewed in the same longitudinal section, the locking portion may include a triangular or truncated profile. Thus, the locking portion may taper as it extends away from the peripheral surface of the sliding member.

[0173] Figure 12L A cross-section of an alternative device for maxillary expansion is shown, comprising an inflatable structure and a spoon-shaped member. The spoon-shaped member defines an intermediate structure disposed between the inflatable 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 a patient's teeth or dental implants. In use, the spoon-shaped member is actuated in a manner similar to the cantilever members and / or sliding members described above. In particular, expansion of the inflatable structure causes the spoon-shaped portion to exert a force on the teeth, resulting in maxillary expansion. The spoon-shaped portion can be configured such that it covers different portions of the labial and lingual surfaces of the teeth. The spoon-shaped portion can be configured such that it does not cover or contact the occlusal surface of the teeth.

[0174] In any of the above embodiments, the tooth-facing surface of the device can be configured to grip the tooth it contacts. Specifically, at least one of the molded structure, the recess, and the intermediate structure can be configured with a tooth gripping portion or a tooth gripper. The tooth gripping portion can include a rounded or pointed nodule protruding from the tooth-facing surface.

[0175] Fig.13A and 13B A component is provided in which a central molding plate can be fixed to the roof of a user's mouth, for example using bone screws or other suitable fasteners. In addition to the central molding plate, there are three additional peripheral molding plates, each shaped to conform to a corresponding surface of the user's mouth, such as a portion of the jaw and / or the inner surface of the teeth. The three peripheral molding plates are connected to the central molding plate by air cells, such as an example of an air cell. Fig. 13BThe airbags are located between the central and peripheral moulding plates in such a way that when the airbags are deflated or only partially inflated with hydraulic fluid, the joint is articulated to facilitate access to the anchor screws. But when the airbags are inflated, the joint becomes more rigid and causes each respective peripheral plate to come into close contact with the portion of the mouth moulding it. The movement of the airbags in the tunnel or between the central and peripheral moulding plates transmits forces to their respective contact points.

[0176] In this manner, the airbag may be configured to directly contact the mold plate structures. The alignment mechanism may be arranged at the joint between the mold plate structures. The alignment mechanism may be configured to maintain the alignment of the mold plates when the mold plates are separated from each other due to the expansion of the airbag. The alignment mechanism may include at least one alignment rod arranged to extend through the passage between the mold plate structures.

[0177] The present invention is not limited to devices for oral applications. Fig.14A and 14B An application of a device 1000 according to an embodiment of the present invention is shown for traction of a skull suture. Many devices can be deployed along one or more sutures. Fig.14A and 14B An example embodiment of an apparatus suitable for this application is shown. Fig.14A Shows Fig. 14B The device 1000 is actually located in the appropriate position on the user's skull. Fig.15A and 15B The devices of FIG. 14 and FIG. 15 are the same, so for the sake of brevity, the detailed description will not be repeated here. The devices of FIG. 14 and FIG. 15 differ from each other only in that Fig.14A and 14B In the case of a screw, the screw has a flat hexagonal head, while in Fig.15A and 15B In the embodiment, the screw has a domed head. The operation of the device is the same. Any embodiment using screw fixation can use a shaped screw, such as a dome-shaped screw, in combination with a "slotted" screw hole, which allows easy replacement of the device without disturbing the permanent fixation, i.e. in the example of the given screw.

[0178] Fig.15A and 15B An unexploded and exploded example of a component 1500 is shown, respectively, which can be used as a central expansion mechanism in various embodiments of the present invention. The mechanism 1500 is substantially symmetrical, so for simplicity, we will only describe the right-hand side here. The mechanism 1500 includes the following major 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.

[0179] 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, the threaded portions having opposite directions. The central area of ​​the threaded component 1524 is free of threads. There is a component 1526 in the center of the central component 1520. Fig.15A As best shown, each rod 1522a, 1522b has a small centrally located notch 1528 in which the central member 1526 rests. The proximal unthreaded portion of the threaded member 1524 is integral with the member 1526. There is a hollow hole 1530 on the top surface of the member 1526. A pin can be inserted into the hole 1530 to rotate the threaded member 1524 about its longitudinal axis.

[0180] The hydraulic component 1540 is relatively simple. It includes a balloon portion 1542, which is an elongated generally cylindrical balloon 1544 having a conical or frustoconical tip 1546 at its distal end. The proximal end of the balloon 1544 is connected to a tube 1548, which is connected to a hydraulic pump (not shown) at its proximal end. The channel component 1560 is preferably a single piece of material, which includes a recess on the outer surface forming a channel 1564, which is shaped to receive the balloon 1544 so that its outer surface is flush with the inner surface of the channel 1564. In a preferred embodiment, when the balloon 1544 is in place within the channel 1564, the outer edge of the balloon 1544 is aligned with or extends through the outer wall of the component. The channel component 1560 also has two holes 1566, 1568 formed therethrough, each shaped to be suitable for receiving one end of the rods 1522a, 1522b of the central component 1520. There is also a recess located between the two holes 1566 , 1568 , which has a hole 1572 located at the center thereof, which is configured to receive the threaded end of the threaded member 1524 .

[0181] The static force applied by the threaded member 1524 is applied through internal threads on the central bore of the channel member, which are configured to engage with external threads on the threaded member 1524.

[0182] The attachment member 1580 is also preferably formed from a single piece of material and includes three holes 1582, 1584, 1586 that align with the holes 1566, 1568, 1572 on the channel member 1560 and are configured to receive the threaded ends of the rods 1522a, 1522b and the threaded member 1524 when they are exposed 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 wing extending horizontally from the base 1586 of the body 1581 and including holes 1588, 1590 that are configured to receive corresponding 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 pin has a specially formed position and locking slot to match the pin. The fixation pin head is spherical so as not to provide any sharp edges that may damage soft tissue. The hexagonal hole is on the top surface of the sphere so that the bone thread attached to the spherical head can be turned with a hexagonal tool. The locating 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 locating portion of the slot is sized to allow it to pass over a spherical head pin previously installed in the bone. The slot is positioned so that the shaft under the spherical head coincides with the smaller diameter of the slot. In addition, the bottom surface of the spherical head locks onto the chamfered edge of the smaller diameter end of the slot. It is held together by the compression force from the screw or balloon dilation device. See FIG. 15C to FIG. 15E .

[0183] When assembled, the threaded ends of rods 1522a, 1522b and threaded member 1524 pass through holes 1566, 1568, 1572, 1582, 1584, 1586. This ensures that the components are properly aligned. Attachment member 1580 is secured to the palate using bone screws 1592, 1594. Member 1500 is then adjusted by turning the threads on threaded member 1524 so that it applies a constant outward force to the palate via 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 balloon 1544. When balloon 1544 is inflated, it serves to extend beyond the plane containing the outer surface of channel member 1560 and thereby exert additional force on the inner surface of attachment member 1580. As this occurs simultaneously, the area between the two pairs of screws on either side of the mechanism 1500 is subjected to tensile forces which, in one application, promote maxillary expansion by separation of the palatal sutures.

[0184] Figures 16A to 16DAn example of an insert that can be worn on a tooth in combination with a device according to other embodiments of the present invention is shown, for the purpose of avoiding, correcting or increasing tooth tilting during a remodeling procedure. The insert comprises a molded retainer-like component having a recess molded to fit the outer surface of the tooth. Each recess / depression is shaped so that the inner surface of the device is in intimate contact with the tooth surface, the uppermost portion and part of the outer surface of the tooth, and there is a structure, in this case a cantilever finger, on the corresponding inner surface of the recess. Fig. 16C and 16D It is shown that there is a small gap between the outer surface of the tooth and the outer wall of the device, allowing the tooth to move and tilt, then be prevented from further rotation, and begin to straighten with further application of force. The insert is preferably used with e.g. Figures 11 to 12B The illustrated embodiments are used in conjunction so that the balloon expands against the insert rather than directly against the tooth. The structure in the recess is preferably positioned so that when the balloon 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 cantilevered 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 has the effect of widening the dental arch by promoting translation of the tooth. Figures 16A to 16D The illustrated embodiment is an upper jaw device, but those skilled in the art will appreciate that a lower jaw device is equally feasible.

[0185] Figures 17A to 17C Various ways in which the devices 700, 800, 900 may be mounted to a user U are shown. It should be noted that the intraoral components of these devices 700, 800, 900 may be used for maxillary / mandibular widening as shown in Figures 1-2, or alternatively, as described below, they may be used for maxillary or mandibular protrusion (forward movement).

[0186] Fig.17AThe embodiment of includes a harness 702 having a central chest 704 with four straps 706, 708, 710, 712 extending therefrom. The back of the harness (not shown) includes a single back plate that is integrally formed with a head plate 714. An additional strap 716 spans across the forehead of the user U to secure the user's head tightly to the head plate 714. The device 700 includes a force generator 718 that is 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 enters the mouth of the user U. Within the user's mouth, the 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 serves to cause the maxilla / mandible to shift forward, thereby causing protrusion of the bone. The presence of the harness 702 with the chest plate 704, back plate and head plate 714 ensures a constant distance between the point where the distal end of bend B and portion 722 contact the craniofacial features of interest within the user's mouth, thereby maximizing the impact of forces on the user's craniofacial structure. Fig. 17B and 17C Respectively Fig.17A The difference is that in Fig. 17B The middle connector 820 is bifurcated at bend B and at Fig. 17C There are two connectors 920a, 920b in. These arrangements help ensure optimal symmetrical protrusion of the ideal craniofacial structure.

[0187] Fig.18 An alternative embodiment of the present invention is shown, which can be used for maxillary protrusion, i.e., pulling the maxilla forward. 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 behind the user's head and extend forward to the bottom of the user's lower jaw. The head support includes a back 1010 that contacts the back of the user's head, and two side portions 1012a, 1012b that are integrally formed with the back 1010 and cover the sides of the user's head. The side portions 1012a, 1012b each include a hole 1014 for the user's ear. There is an adjustment device 1016 at the top of the head support 1002, 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 side portion 1012a, 1012b, there is a corresponding motor 1004a, 1004b. Fig.18In the illustrated embodiment, the motors 1004a, 1004b are stepper motors, but those skilled in the art will appreciate that other types of motors may be used in practice. Each motor 1004a, 1004b is connected to the proximal end of a corresponding telescopic arm 1006a, 1006b, each telescopic arm serving 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.

[0188] Fig.19 The crossbar 1008 is shown in more detail in an 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 either side of the wide portion 1022. Two holes 1026a, 1026b are formed in the wide portion 1022. A zeroing screw 1028a, 1028b passes through each hole 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. At the distal side F of the plate 1020, a pull rod or cable 1034a, 1034b is attached to the end of the screw 1028a, 1028b, at the distal end of which a bone screw 1036a, 1036b is positioned. To assemble the device, the crossbar 1008 is in a fully retracted position (i.e., the telescopic arms 1006a, 1006b are fully retracted). The pull rod or cable 1034a, 1034b is then attached between the bone screw 1036a, 1036b and the screw 1028a, 1028b, and the attachment mechanism may also be easily reversible, such as a hook or buckle between the bone screw and the pull rod or cable. The tension ring 1032a, 1032b is then turned until a predetermined tension can be felt in the bone screw 1036a, 1036b.

[0189] In operation, the movement of the stepper motors 1004a, 1004b is converted into the extension / retraction of the telescopic arms 1006a, 1006b, thereby causing the crossbar 1008 to move forward and backward in front of the user's face. In particular, when the telescopic arms 1006a, 1006b are extended, 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, thereby causing changes 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 be constructed in the bone screws 1036a, 1036b. Alternatively or in addition, the telescopic arms 1006a, 1006b (and other components) can be adjusted manually or by an actuating component.

[0190] Fig. 20A and 20B An alternative crossbar structure 1108 is shown, wherein like numerals refer to the same crossbar structure as in FIG. Fig.19 The same features in . Fig. 20A and 20B The crossbar 1108 and Fig.19 The crossbar 1008 of FIG. 1004 differs in that it also includes strain gauges 1138a, 1138b for measuring the strain in the rods or cables 1134a, 1134b.

[0191] Fig.21 Similar to Fig.18 except that the actuator is a hydraulic pump instead of a stepper motor. Figures 22A to 22C The hydraulic airbags are used to increase the distance between the lifting plate and the rear lifting plate, thereby increasing the tension in the pull rod / cable.

[0192] Fig.22A An exploded view of the crossbar structure is shown. The operation of the structure is as follows:

[0193] -The hydraulic actuator is in the fully retracted position and the hydraulic bladder is deflated.

[0194] -The pull rod / cable is attached between the bone screw and the non-rotating slider.

[0195] -Then turn the zeroing screw until tension is felt in the bone screw.

[0196] -At this point, the riser is flush with the front bracket.

[0197] - Now, the device is in a "resting position".

[0198] - Coarse oscillation can be achieved by extending and retracting the hydraulic actuator.

[0199] -Pressure changes in the hydraulic actuator provide feedback information of loading the bone. This provides a low frequency potential oscillating force in one example.

[0200] -Pressure changes in the hydraulic bladder move the lifting plate forward, thus applying a load to the bone. Pressure changes in the hydraulic bladder also provide feedback information about loading the bone. This is used for small high frequency pulsating forces.

[0201] As described herein, each hydraulically actuated head support device can be configured with at least one removable self-sealing connection. The self-sealing connection can include, for example, at least one of a one-way valve and a reversible valve. The self-sealing connection is configured to enable a hydraulic pump to be reversibly connected to one or more hydraulic bladders without affecting the hydraulic pressure in the bladders.

[0202] Fig. 22B and 22CThe riser plate assembly is shown in more detail and can be described as follows:

[0203] -The universal clamp slide is connected front and back by two parallel slide rails, which slide freely through two slide rail bushings.

[0204] -The bushing is fixed to the fixed structure.

[0205] -The zeroing screw is attached to a rod or cable that is attached to the skull.

[0206] - In the retracted state, the front universal clamp slide (front) is in contact with the vertical surface of the fixed structure. This is the static state.

[0207] -When the hydraulic bladder is inflated, the universal clamp slide (front) is forced away from the vertical fixing surface.

[0208] -direction will be to the left and cause the zeroing screw to create tension in the rod or cable attached to the skull.

[0209] - By changing the volume of hydraulic fluid in the hydraulic bladder, the distance between the universal clamp slider (front) and the fixed structure tension in the rod or cable will change and therefore the tension applied in the cable or rod connected to the skull will also change.

[0210] - In order to create compression on the skull through the rod, the universal clamp slide (posterior) must be pushed in the right-hand direction. This can be achieved by positioning the hydraulic bladder to the right of the fixed structure and inflating the hydraulic bladder, forcing the universal clamp slide (posterior) away from the fixed structure and pushing the zeroing screw to the right-hand side.

[0211] Fig.23 Shown with Fig.18 The device is similar to the device of the , except that there are two sets of stepper motors and two crossbars. In this way, the extension force can be applied evenly throughout the vertical range of the skull.

[0212] Fig.24 An alternative arrangement is shown in which the rigid arched support is secured to the skull using bone screws or other suitable fasteners. A rigid center rod is attached to the center of the rigid arched support and the other end of the step is attached to a crossbar, e.g. Figures 19 to 20B The device is similar to, for example, Fig.21 The device operates in the same manner as described above, except that the device is secured 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 may include a hydraulic pump or a stepper motor and may be mounted to a rigid arch support. The actuator may be removably mounted to the arch support. In addition, the crossbar may also be removed from the wider structural arrangement.

[0213] Figures 25A to 25F is a schematic diagram of an embodiment in which force is applied to the space between the zygomatic bone and the maxilla. In the embodiment shown, an L-shaped connector is used, the outer end of which (i.e., the end that does not contact the skull) can be attached to a device, such as Figures 17A to 17C , 18, 21, 23, 24, 26, 29A, 30, 31A, 32A, 34A. Fig.25A and 25B In the L-shaped connector configuration, maxillary protrusion is used. Fig.25C In the example, the L-shaped connector is configured for maxillary expansion. It should be noted that although Figures 25D to 25F The connector in is shown as a sharp L-shape, but in a preferred embodiment of the invention the connector will be shaped to the contour of the bone surface in question, as well as to allow for any occupancy of the expandable structure. Figures 25D to 25F Three different ways in which forces can be transmitted to relevant skull structures are shown:

[0214] -exist Fig.25D In the present invention, 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.

[0215] -exist Fig.25E In the embodiment of the present invention, the airbag is in place between the connector and the zygomatic bone. The connector is fixed in place and can apply a constant force to the bone. The force is transmitted to the zygomatic bone through the periodic expansion and contraction of the airbag. In some embodiments, the airbag can be dynamically expanded / contracted to provide an "active cushioning" effect when the connector is actuated.

[0216] -exist Fig.25F In an embodiment, 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 cyclically expanded / contracted, the zygomatic bone is displaced laterally (because it is less resistant to movement than the maxilla). By using, for example Fig.25D Any adverse compression of the maxilla can be overcome by placement of the 25E within the palate, or by use of other intraoral devices such as those described elsewhere in this patent application.

[0217] Fig.26 The device 1300 is similar to, for example Fig.18 1300 is a device similar to that shown in the drawings, but is used when the user is lying horizontally rather than sitting or standing upright. It will be appreciated that similar reference numerals are used below to indicate similar structures. The device 1300 includes a head support 1302, motors 1304a, 1304b, telescoping arms 1306a, 1306b, and a crossbar 1308. The head support 1302 includes a headrest 1310 and side portions 1312a, 1312b, the headrest 1310 including a cavity for receiving the head. In a device such as Fig.26In the "lie flat" arrangement shown, the weight of the user's head is used to prevent the user's head from moving forward during the application of the cyclic force.

[0218] The head support 1302 optionally also includes additional frame elements 1340 (only one is shown, but those skilled in the art will appreciate that there may be one on each side, or none at all) that are integrally formed with the side portions 1312a, 1312b. Each frame element 1340 includes a slot 1342 into which a corresponding protrusion on the motor 1304a, 1304b fits. The operation of the device 1300 is the same as that of the previous device, but the orientation is different.

[0219] Figures 27A to 27B An alternative example is shown in which the connector between the crossbar and the actuator can be rotated, such as shown, to connect the pull rod to the intranasal structure. Fig.28 The device arrangement shown in A is used to reshape the proximal skull structure including the ethmoid bone. In an alternative arrangement, the head mount is configured so that the attachment point is provided at the cheek bone or zygomatic bone. The frame elements and motors are configured to generate an expansion force that is applied to the cheek bone in a generally upward direction. It is recognized that although the force applied by the frame elements is expansion, the patient will be subjected to a compressive force.

[0220] Fig.29A and 29B Shown is an alternative embodiment of the device, which can apply more varied range of periodic forces to the craniofacial structure of the user.Device 2000 comprises a main body 2002, which comprises a side 2004a, 2004b that is installed on a base 2006.Each side 2004a, 2004b comprises a semicircular portion 2008a, 2008b, which comprises a semicircular recess 2010a, 2010b, and recess 2010a, 2010b is limited by inner wall 2012a, 2012b and outer wall 2014a, 2014b.Inner wall 2012a, 2012b comprises slot 2016a, 2016b separately, and outer wall 2014a, 2014b comprises slot 2018a, for example separately.The space between the side 2004a, 2004b is approximately the width of a human head.

[0221] The device 2000 also includes five arcuate tracks 2020, 2022, 2024, 2026, 2028. It will be appreciated by those skilled in the art that other embodiments of the present invention may have fewer (i.e., one, two, three, or four) tracks or more tracks. In the illustrated embodiment, each of the arcuate tracks 2020, 2022, 2024, 2026, 2028 is semicircular, but other arcuate shapes may be equally used. Each end of each arcuate track 2020, 2022, 2024, 2026, 2028 is located within a corresponding one of the semicircular recesses 2010a, 2010b and has a protrusion extending through each inner slot 2016a, 2016b and an outer slot such as 2018a.

[0222] Each arcuate track 2020, 2022, 2024, 2026, 2028 includes a mounting recess or slot 2030, 2032, 2034, 2036, 2038 extending along most or all of its length. Typically, these slots 2030, 2032, 2034, 2036, 2038 are used to mount a component on the arcuate track in question, which component may be a force generator, a force transmitter (or both), or an anchor.

[0223] exist Fig.29A , it will be apparent that each of the arcuate rails 2020, 2024, 2026 and 2028 has a different attachment. A vibration plate assembly 2040 is mounted on rail 2020. The vibration plate assembly includes a vibration plate 2042, a force generator 2044, a rod 2046 (which may be telescopic), and a mounting member 2048. The force generator 2044 is mounted to the rail 2020 via the mounting member 2048. The output of the force generator 2044 is transmitted to the rod 2046 and then to the vibration plate 2042. In this case, the vibration plate is flat, but in some alternative embodiments, the plate can be shaped to fit various craniofacial structures. It should be understood that although Fig.29A The embodiment shown only shows a single track 2020 with a vibrating plate assembly 2040, but other embodiments may have additional vibrating plate assemblies. In embodiments where, for example, an upward force is applied by one or more force transducers, the plate may not vibrate and may 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.

[0224] Tracks 2024, 2026, 2028 each have a force transfer component 2050, 2052, 2054 thereon. The structure 2054 on track 2028 is equivalent to the crossbars 1008, 1108, 1308 previously described in this application. The difference is that the equivalent feature of plate 1020 is slightly curved so that it can slide along track 2028 without resistance. Assembly 2054 is configured to apply tension to a given craniofacial structure, and includes force generators 2058a, 2058b, force transmitters 2060a, 2060b, and may have a pull rod or cable (not shown) connected thereto. Similarly, assembly 2052 is configured to apply tension to a given cranial structure, and includes force generator 2064, and may have a pull rod or cable connected thereto.

[0225] Components 2050 and 2052 are compression force transmitters that operate in the same manner as vibrating plate assembly 2040, but with plates 2062 of different shapes (ie, smaller).

[0226] exist Fig.29A In the illustrated embodiment, member 2050 is capable of rotating relative to track 2024 in order to change the direction in which it is able to apply a compressive force.

[0227] Fig.30 Shows something like Fig.29A An embodiment wherein the head pad is mounted on the base.

[0228] Fig.31A and 31B Shown with Fig.29A and 29B The device of the present invention is similar to the device of the present invention, except that the tracks 2120, 2122 are oriented vertically, rather than horizontally, and are therefore able to rotate from left to right around the user's head, rather than from top to bottom. The components located on the tracks are able to move in an up and 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.

[0229] Fig.32A and 32B A modified version of the device with a vertical track is shown in which the wall has been removed to reduce the restriction on movement in the lateral direction. 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 are able to oscillate about their axis to apply a torque to the skull surface. These oscillations can be limited to + / -45°, such as a quarter turn push down. These oscillations can be uniform sinusoidal or random.

[0230] In one example, one pressure pad may apply an inward rotational force while the other side may apply no or a constant opposing force to restrict head movement.

[0231] Fig.33A and 33B A skull reconstruction helmet 3300 according to an embodiment of the third aspect of the present invention is shown. The inner surface of the helmet 3300 is shaped to fit the outer surface of the user's head. Fig.33B As shown, the inner surface of the helmet 3300 includes a plurality of cylindrical air bags 3302. Fig.33B The airbag 3302 is shown to cover only part of the inner surface of the helmet 3300, but 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 ring-shaped. In use, the two anchor points can correspond to two points on the user's skull that are opposite 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. Through the cyclic expansion and contraction of the airbag 3302, a cyclic force can be applied to the skull. In a preferred embodiment, the size of the helmet 3300 is designed to fit tightly on the user's head so as to provide a "background" compressive force, which is then supplemented by the cyclic force provided by the expansion and contraction of the airbag 3302. The airbags can be connected directly to the hydraulic compressor individually, or they can be connected as a daisy chain so that the entire airbag block will expand simultaneously. As the hydraulic airbags are contracted, the helmet is placed on the head and the airbags are expanded. The airbag pressure can be varied to any waveform that is desired to produce a pulsating massage effect. By properly interconnecting the airbags and multiple pressure lines to a compressor, the airbags can achieve an undulating massage sequence when they are sequentially inflated / deflated. Note that in this and all other embodiments of the invention, there can be multiple airbags, which can have different shapes, sizes, orientations, and locations (including proximity relative to the skull). The airbags can also be different textures. There can be additional elements to replace the inflated airbags, or similarly, the inflated airbags can replace additional elements.

[0232] Figures 34A to 34C This is a simplified diagram of the skull cranial apparatus. Fig.34A In the embodiment of the invention, the user places their head on the lower seat, which includes a recessed portion to allow it to better conform to the shape of the user's head. The upper portion can then be lowered onto the user's face. The device is preferably configured to fit snugly on the user's face so as to provide a background force. The periodic force can then be applied hydraulically, for example using a Fig.33A and 33B Alternatively, the upper portion may have other components that apply compression or tension, such as Fig.29A and the compression force transmitters shown in 31 and 32B. Fig.34Band 34C Other device configurations are shown in which the device according to the invention can be installed.

[0233] Fig.34D and 34E A similar embodiment is shown having a "butterfly" arrangement where the two sides converge inward across the user's face.

[0234] Figures 34A to 34E The embodiment shown can be modified to provide tension rather than compression to the skull structure. For example, the attachment portion located on the inner surface of the device can be arranged to connect to, for example, a bone screw or other fixation device on the user's skull, so that tension is applied to the fixation device. This will represent a background force, and a periodic force can be hydraulically applied thereto in the same manner as other embodiments.

[0235] Fig.35 There is shown a horizontal platform shaped for accessing the mouth connected by two arms to an actuator which may be mounted to a back plate or track such as shown in Figures 29, 30, 31 and 32. When the platform is actuated it applies a force to an anchor point in the mouth.

[0236] Fig.36A and 36B The structures are shown attached to a horizontal platform and in these examples are arranged to apply force to the palate without involving the teeth. Fig.36A As shown, the expandable structure is arranged between the lateral arms and the horizontal platform of the device. Fig.36B In the alternative arrangement shown, the expandable structure is disposed between the palate and the curved surface of the device. Fig.36A and 36B In each of the arrangements shown, an inflatable structure is used to apply force to the palate. Fig.36A In the case of Fig.36B In the case of the arrangements shown, the force is applied directly to the palate. In each of these arrangements, the horizontal platform is held in place by applying a constant force indirectly (i.e., through an intraoral device) or by no constant force at all. The inflatable pads may also serve as "active cushioning" when the horizontal platform is actuated. For example, the inflatable structures may be sealed so that they can passively absorb the forces exerted on them by the platform. Alternatively, the inflatable structure may be connected to a hydraulic actuator configured to cause the application of a constant or dynamic force.

[0237] according to Fig.36A and 36B Alternatively to the arrangement shown, the inflatable structures may be arranged between the arms of the device and the occlusal surface of the tooth. Thus, activation of these inflatable structures will result in the application of forces directly on the tooth. Fig.36A and 36BOther arrangements of the inflatable structure may be provided in addition to the arrangement shown.

[0238] Fig.38A and 38B A Matthew-Tesser retractor is shown that may be used in conjunction with embodiments of the present invention.

[0239] Although the present invention has been described in conjunction with the above exemplary embodiments, many equivalent modifications and variations will be apparent to those skilled in the art when this disclosure is given. Therefore, the exemplary embodiments of the present invention described above are considered to be illustrative rather than restrictive. Various changes may be made to the described embodiments without departing from the scope of the present invention. All references mentioned above are incorporated herein by reference.

Claims

1. A device for skull reconstruction by expansion, compression or bending of a skull structure between a first anchor point and a second anchor point, the device comprising: a force generator configured to generate a periodic force; a first anchor for attachment to a first anchor point; a second anchor for attachment to a second anchor point; a first component configured to transmit a static force to the first anchor and / or the second anchor; and a second component configured to transmit a cyclic force to the first anchor and / or the second anchor, wherein the second component includes a hydraulic force transmitting structure connected to the force generator and configured to transmit a cyclic force to the first anchor and the second anchor to place the skull structure in at least one of: tension, compression or flexion, wherein the force transfer structure comprises a first channel including an expandable structure; and Wherein, the expandable structure is an elongated cylindrical airbag.

2. The device according to claim 1, wherein: The force generator is configured to generate all or part of the static force as well as the periodic force.

3. The device according to claim 1, wherein: The force transmitting structure includes a first expandable structure rigidly connected to the first anchor and / or a second expandable structure rigidly connected to the second anchor.

4. The device according to claim 3, wherein: The first and second expandable structures are connected to each other in series.

5. The device according to claim 1, wherein: The force transfer structure includes a molded structure, which includes a first recess, which is formed to match at least one of the following: an inner surface, an outer surface and an occlusal surface of a first tooth, and the recess includes a first intermediate structure, and the surface of the first intermediate structure is arranged to contact the surface of the first tooth when the device is located in an appropriate position in the user's mouth.

6. The device according to claim 5, wherein: The first channel is located in a portion of the moulding structure behind the first intermediate structure, and the expandable structure is arranged such that when it expands, it exerts a force on the first intermediate structure, and the force is transmitted to the first tooth via the first intermediate structure.

7. The device according to claim 6, wherein: The molded structure includes a plurality of recesses, each recess being shaped to conform to the inner surface of a corresponding tooth, and each recess including a corresponding intermediate structure having a surface arranged to contact the surface of the corresponding tooth when the device is in position within the user's mouth.

8. The device according to claim 7, wherein: The first channel is arcuately shaped and is located behind each respective cantilever structure such that when the expandable structure expands, it exerts a force on each intermediate structure, and the force is transmitted to each tooth through the respective intermediate structure.

9. The device according to any one of claims 5 to 8, wherein: The intermediate structure is at least one of: a cantilever structure, a sliding member, and a weakened portion of a wall of the recess.

10. The device according to claim 1, wherein: The device is modular.

11. The device according to claim 1, wherein: The force generator is removable.

12. The device according to claim 1, wherein: The force generator is connectable to at least a portion of the force transmitting structure by a removable self-sealing connection.

13. The device according to claim 12, wherein: The removable self-sealing connection comprises a valve.

14. The device according to claim 12, wherein: The detachable self-sealing connection includes at least one of a one-way valve and a reversible valve.

15. The device according to claim 1, wherein: The force transfer structure is configured to transfer a first force to the first anchor and a second force to the second anchor, wherein the first force is in an opposite direction to the second force.

16. The device according to claim 15, wherein: The force transfer structure is configured to apply the generated force directly to the first anchor only, and wherein in use, the first force is applied as a reaction force to the second anchor via the skull structure.

17. The device according to claim 1, wherein: The force transfer structure is configured to apply the generated force directly to the first and second anchors.

18. The device according to claim 1, wherein: The device defines an expansion mechanism for performing maxillary or mandibular expansion, The hydraulic force transmission structure includes first and second expandable structures, first and second channel components arranged to respectively accommodate the first and second expandable structures, and a central component arranged to connect the first and second channel components; The first anchor point defines an attachment feature of a first channel member and the second anchor point defines an attachment feature of a second channel member.

19. The device according to claim 18, wherein: The attachment member includes a wing extending from a body of the attachment member, the wing including an aperture configured to receive a fastener configured to secure the attachment device to a cranial structure of a user.

20. The device according to claim 19, wherein The hole includes a locating slot configured to releasably couple the wing portion to the fastener, wherein the locating slot includes two intersecting circular 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.

21. The apparatus of claim 1, wherein: The first anchor point is a first tooth, and the first anchor includes a first tooth contacting component configured to: Wrap around the first tooth, or Adjoining the inner or outer surface of the first tooth.

22. The apparatus of claim 21, wherein: The first tooth contacting member comprises one or more of: a wire, a band, a plate, or another orthodontic fixture.

23. The apparatus of claim 21, wherein: The second anchor point is a second tooth, and the second anchor includes a second tooth contacting component configured to: Wrap around the second tooth, or Adjacent to the inner or outer surface of the second tooth.

24. The apparatus of claim 23, wherein: The second tooth contacting member comprises one or more of: a wire, a band, a plate, or another orthodontic fixture.

25. The device according to claim 21 or 23, wherein: The first tooth contact member or the second tooth contact member includes a portion shaped to conform to a surface of a first tooth or a second tooth, respectively.

26. The apparatus of claim 1, wherein: One or both of the first and second anchors include a screw configured to directly contact bone or soft tissue.

27. The apparatus of claim 1, wherein: The force generator is configured to generate a force having a profile including a non-periodic region and a periodic region.

28. The apparatus of claim 1, wherein: The force generator is configured to receive input from the measurement device and to adjust a characteristic of the generated force in response to the input from the measurement device.

29. The apparatus of claim 28, wherein: The force generator is configured to adjust a characteristic of the force to maintain a constant remodeling rate of the skull structure.

30. The device according to claim 28 or 29, wherein: The measuring device comprises: a pressure gauge, a strain gauge, a device for measuring the displacement of the skull structure, an electrocardiograph, an electroencephalograph or an electromyograph.

31. The apparatus of claim 1, wherein: The force generator is an external force generator.

32. The apparatus of claim 1, wherein: The force transfer structure is configured to transfer force from outside the body of the user to a location inside the body of the user.

33. The apparatus of claim 1, wherein: The force generator is located within a housing configured for attachment to a harness.

34. The apparatus of claim 1, wherein: The force transmitting structure includes one or more inextensible, incompressible wires configured to transmit the force as a tensile force.

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