Cranial restructuring device

Abstract

To provide a device configured to apply periodic force to bones, teeth, or other parts of a body and to modify structure thereof, for example, by enlarging, compressing or lengthening.SOLUTION: There is provided a cranial restructuring device by enlarging, compressing or bending a cranial structure located between a first anchor point and a second anchor point. The cranial restructuring device includes: a force generator configured to generate force; a first anchor for attachment to the first anchor point; a second anchor for attachment to a second anchor point; a hydraulic force transmitting structure connected to the force generator, and configured to transmit the generated force to the first anchor and the second anchor thereby putting the cranial structure in at least one of: tension, compression or flexure. The force transmitting structure is a hydraulic force transmitting structure.SELECTED DRAWING: Figure 29B

Description

[Technical Field]

[0001] The present invention relates to a device for cranial and / or orthodontic remodeling that is primarily achieved by the application of cyclic forces. [Background technology]

[0002] It is well known that dental devices or systems, such as braces, oral appliances, retainers, etc., can be used to reposition teeth and modify a user's dental arches. These work by applying a constant static force to the teeth to which they are attached. More precisely, the force experienced by each tooth decreases over time as the teeth change position as a result of the constant force applied to the teeth.

[0003] In many cases, to have a meaningful effect, the appliance must be worn 24 hours a day, such as with a fixed brace, exerting constant force on the wearer's teeth. This can be uncomfortable for the wearer. A similar situation can arise when attempting to correct the wearer's facial bone structure. This often requires cumbersome reinforcing structures, such as headgear, which can be removable or fixed in the form of cranial distraction devices, and often requires wear times in excess of 12 hours, or, in the case of fixed appliances, full-time. Summary of the Invention [Problem to be solved by the invention]

[0004] Generally, the present invention aims to address this problem by providing a device configured to apply a cyclic force to bones, teeth, or other parts of the body to remodel those structures by, for example, expanding, compressing, or lengthening. As will be described below, in some cases, the applied cyclic force is superimposed on a static force for added effectiveness. [Means for solving the problem]

[0005] Although the first aspect of the present invention primarily relates to devices configured to perform reconstruction of the maxilla, mandible, dental arch, or palate, it will be appreciated that devices according to embodiments of the first aspect of the present invention may also be used for other types of cranial reconstruction. More specifically, the first aspect of the present invention provides a cranial reconstruction device that achieves this by expanding, compressing, or bending cranial structures located 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 the first anchor point; a second anchor for attachment to the second anchor point; and a force transmission structure connected to the force generator and configured to transmit a cyclic force to the first anchor and the second anchor, thereby placing the cranial structure in at least one of tension, compression, or flexion. It will be appreciated that more than two anchors may be provided and that one anchor point may constitute a group of structures.

[0006] Applying dynamic forces to bone structures has been shown to result in greater bone growth compared to static forces. Combining 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.

[0007] It will be understood throughout this application that forces applied to the teeth may also result in compression and stretching of intermediate structures, such as the periodontal ligament, with varying effects on tooth movement and bone remodeling under different loading regimes. It will also be understood that cranial structures and sutures may undergo varying amounts of compression and / or stretching depending on the loading regime.

[0008] The force generator is preferably an external force generator. In other words, during use, the force generator is preferably located or positionable outside the user's body. Herein, "periodic force" can refer to a cyclic force (i.e., a periodic force having a constant frequency or period), but it should be understood that it also encompasses quasi-periodic forces, e.g., with varying frequency or period. In other words, the force can be a variable force with a variable period. In the case of a cyclic frequency, the frequency is preferably within the range of 1-400 Hz, and in embodiments with varying frequency (i.e., a quasi-periodic force), the frequency preferably varies between 1 Hz and 400 Hz. The waveform of the periodic or quasi-periodic force is preferably one of a triangular, sinusoidal, sawtooth, spike, or square. The force can also be any superposition of these. It should be understood that other periodic waveforms are also encompassed by this definition.

[0009] The periodic force is preferably a unidirectional force. In other words, the periodic force action is preferably not a "push-pull" action, but rather a push or pull action that varies periodically (or quasi-periodically) over time. In this way, the force applied to the primary cranial structures acts to cause remodeling in only a single direction. The force generator can be configured to generate forces other than periodic forces, such as continuously varying forces or constant forces, or combinations thereof. Specifically, the force profile 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 having a profile that includes alternating periodic and non-periodic regions. In some embodiments, the non-periodic regions can include a constant force, while in other regions, the non-periodic regions can include a linearly or otherwise increasing / decreasing force. In preferred embodiments, the periodic / quasi-periodic portion of the force preferably oscillates around a non-zero force. Preferably, when the force oscillates around a non-zero force, the minimum value of the oscillation does not fall below zero. In this way, it is possible to ensure that a force is constantly applied to the primary cranial structure. This is in contrast to a force that oscillates at a zero point, where the force can no longer be applied approximately one-half the time. In some embodiments, the force characteristics (e.g., duration, amplitude) can be adjusted based on continuous or intermittent input from a data processor arranged to receive input from a measurement device, such as a pressure gauge, strain gauge, or device that measures displacement of a cranial or other body structure. Other forms of input, such as an electrocardiogram (ECG), an electroencephalogram (EEG), and an electromyogram (EMG), are also encompassed. In this way, the device can operate as a feedback system. In some cases, feedback can be obtained from the operation of an embodiment informing the activity of one or more other devices. A hydraulic machine can be used in conjunction with a displacement feedback mechanism to achieve a constant distraction rate.

[0010] It should be noted that throughout this application, reference is made 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 acts to cause movement of the structure in the direction of the constant force. The force upon contact is preferably constant.

[0011] For example, when a force is provided by a tensioned wire or an expandable structure, the extension of the wire (or expandable structure) decreases as the structure moves, i.e., the static force decreases very slowly over time. Throughout this application, these forces change gradually over time, but are nevertheless referred to as "static forces" or "constant forces." Throughout this application, the terms "constant force" and "static force" should nevertheless be considered to encompass forces that fluctuate negligibly or not at all over the timescale of one period of a nearly periodic force. A "true" constant force can be generated by an actuator with a feedback loop. As the structure moves, the pressure in the system drops and corrects to its initial value, thus maintaining a constant force. The contact surface area between the anchor point and the anchor can change after a single correction or a series of corrections.

[0012] In some cases, there may be two ways in which force is applied to the first or second anchor. Specifically, the first component may apply a static force to the first and / or second anchor, and the second component may apply a cyclic force to the first and / or second anchor. In this way, a constant "background" force may be applied, onto which the cyclic force generated by the force generator may be superimposed. The force provided by the first component is preferably 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 rapid maxillary expander. In such cases, when a user wears the appliance, the cranial structure to be reconstructed is subjected to a constant static extension or elongation force. For example, when a user requiring expansion of the maxillary dental arch wears such an appliance, the appliance may apply a constant force in a lateral outward direction to the upper teeth. This force on the teeth acts to extend the upper palate and flex the maxilla, thus resulting in gradual lateral maxillary expansion.

[0013] When the device includes a component that generates a static force, the force generator does not need to generate a periodic force with a significant magnitude because the periodic component of the force is superimposed on the static component of the force provided by the static component. Alternatively, the force generator can generate all or part of the static force as well as the periodic component. The static component is preferably shaped to expose the first and second anchors to the first and second anchor points, respectively, to ensure that the anchors are attached to the anchor points for efficient force transmission. For example, the static component can include holes or windows. Alternatively, the static component can include means for connecting the static component to the rest of the device to ensure that, in use, the force components constructively increase rather than, for example, canceling each other out. Embodiments of the invention in which the device includes a static component ensure that the force resulting from the superposition of the static and periodic components of the force is always positive, i.e., acting in the correct direction to achieve the desired restructuring.

[0014] Embodiments of the present invention are adapted to perform cranial remodeling by causing expansion, compression, or bending of cranial structures. For example, in some embodiments, the device can be used for mandibular or maxillary expansion, where the mandible / maxilla expands laterally and forward. Alternatively, the device can be used for maxillary or mandibular lengthening, where the mandible / maxilla is moved forward, for example. Lengthening can also stimulate growth by straining the bone. In some embodiments, other movements, such as retraction of the teeth or maxilla, can also be achieved. This also includes inward movement of the teeth, or more generally, inward movement. Some embodiments of the present invention can also allow movement of one or more teeth along or around any axis, such as rotation, or a combination thereof. It should be noted that in some applications of the present invention, the desired effect is movement of two cranial structures (e.g., maxillary expansion, where movement of both the left and right sides of the maxilla, i.e., bony displacement, is desired, whereby the left and right sides of the maxilla are separated by arthrodesis of adjacent sutures, or even more simply if no or little suture fusion occurs), while in other applications, the desired effect is movement of one cranial structure (e.g., maxillary lengthening, where the desired result is to move the maxilla forward). However, the mode of operation in both of these cases is substantially identical, as they are both achieved by expansion of some cranial structure to increase the distance between two fixation locations on the skull. The same applies to compression and flexion actions. The present application encompasses various different uses of the present invention in addition to those described in this paragraph. It will be recognized that asymmetric treatment of the structure in question can be achieved, for example, on one side of the maxilla, with or without suture separation.

[0015] The device of the present invention operates by transmitting a first force to a first anchor and a second force to a second anchor, the first force being in an opposite or substantially opposite 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 to only the first anchor. In these embodiments, the first force is transmitted through the cranial structure to the second anchor, and the cranial structure experiences the 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 will be appreciated by those skilled in the art, applying two forces in opposite directions to the cranial structure via two anchor points results in tension or compression forces within the cranial structure, which in turn produces the desired cranial remodeling. In some embodiments, for example, when the cranial structure is not located on a straight line connecting the first and second anchor points, the opposing first and second forces can instead act to cause bending of the cranial structure. This applies equally well when the cyclic force is applied only to the second anchor, but for simplicity's sake, that discussion will not be repeated here.

[0016] In other embodiments, the force transmission structure is configured to apply cyclic forces directly to the first anchor and the second anchor. Specifically, the force transmission structure is configured to apply a first force directly to the first anchor and a second force directly to the second anchor. As noted above, the first and second forces are preferably equal and opposite in magnitude to generate tension or compression in cranial structures located between the first and second anchor points.

[0017] The mechanism by which forces are transmitted to the first and second anchors has been discussed above. The nature of these forces and their transmission to the first and second anchors by the force transmission structure will now be discussed. In some embodiments, the force generator includes a motor, such as a stepper motor, configured to generate rotary motion. In such cases, the force generator preferably further includes a means for converting rotary motion to reciprocating motion. These means may include a crank, a screw thread, or a cam. Those skilled in the art will recognize that there are numerous other components that can be used to effect this conversion. As discussed, the force generator is preferably an external force generator, and as will become apparent, the first and second anchor points are generally located within some cranial structure of the user, such as the mouth or nose. Thus, the force transmission structure is preferably configured to transmit a cyclic force from outside the user's body to a location within the user's body. Specifically, in preferred embodiments of the present invention, the force transmission structure is configured to direct the force in an anterior-posterior direction, i.e., anterior-posterior, relative to the user's body. It should be noted that in some embodiments, a periodic force can be generated in this direction, in which case the force transmission structure need only maintain that direction, while in alternative embodiments, a force can be generated in, for example, an upward-downward direction, and the force transmission structure includes a mechanism for changing the direction of the force. The force generator can be located within a housing, which is configured to be attached to a harness. In some embodiments, the harness can be a chest harness.

[0018] The force transmission structure may include one or more non-expanding and non-compressible wires configured to transmit the generated cyclic force as a tension force. However, in a preferred embodiment of the present invention, the force transmission structure is a hydraulic force transmission structure, which utilizes the incompressibility of a fluid, such as water or oil, to transmit the force generated by the force generator as a compression force. The hydraulic force transmission structure preferably includes one or more inflatable / collapsible structures, such as balloons or bellows, that can be inflated by a fluid to transmit the cyclic force to the first anchor or the second anchor. Specific embodiments of the present invention that use hydraulic transmission structures are described later in this application. Hydraulic force transmission structures are particularly effective because they have been shown to reduce potential mechanical system failures. In other embodiments, force transmission may include or be in the form of a pneumatic or piezoelectric force transmission structure.

[0019] In some embodiments of the present invention, the device may be modular. In other words, any or all of the force generator, force transmission structure, first anchor, and second anchor may be removable from the device and therefore replaceable with alternative components. In other embodiments, a portion of the device may be fixed to or configured to be fixed to the user's cranial structure and connectable to the remainder of the device. For example, at least one of the force transmission structure, first anchor, and second anchor may be fixed to or securable to the user's cranial structure and connectable to the force generator. This type of modular structure is advantageous because it means that the fixed structure may be more securely fixed, e.g., surgically implanted or attached, which should result in more efficient transmission of force from the force generator to the cranial structure to be modified or reconstructed.

[0020] A modular structure is advantageous, for example, when no force generation is required, and the force transmitter and force generator can be decoupled, and in some embodiments, the force can be self-sustaining or radiating. Thus, the existing structure remains as small and unobtrusive as possible, improving patient comfort and minimizing complications such as entanglement and other forms of accidental injury.

[0021] Modular hydraulic force transmission structures are particularly advantageous in some embodiments because they allow a single hydraulic force generator to be removably connected to multiple different portions of the force transmission structure, allowing the force being applied by each of the different portions to be individually adjusted. Again, this refers to a valve-like or other form of severable but self-sealing / sealing connection, such as a one-way or reversible valve. The valve can be located proximal to the oral appliance within the body of the device, or it can extend slightly from the device. If tubing leading from the mouth is not in the way, 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. The force transmitter, which may be in the way when the device is not in use, can be disconnected from its connection by a self-sealing valve, as well as being detachable itself. This is not only convenient, but also reduces the risk of iatrogenic injury. The self-sealing valve allows pressure to be maintained within the system. This pressure generates a fixation force that decays over time, much like a wire under tension. Advantageously, the system can be "reset" (intermittently) several times a day to maintain the pressure, and therefore the force on the teeth. Alternatively, if the cranial structures are displaced or remodeled, thereby reducing the effective force / pressure on the structures, the device can be configured to increase the force provided by the force generator to ensure a constant force is maintained on the cranial structures. According to an exemplary embodiment, a self-sealing valve can be configured to allow a hydraulic fluid-carrying hose or catheter to be connectable and disconnectable to a first hydraulic force transmission structure portion. A first end of the hose can be fluidly connected to the hydraulic force generator, and a second end of the hose can be configured to be reversibly connectable to the first hydraulic force transmission structure portion. The hose can further be reversibly connectable to a second hydraulic force transmission structure portion. The self-sealing valve can be configured to maintain the hydraulic fluid pressure within the force transmission structure portion when the hose is disconnected.The modularity of the device components means that a single hydraulic force generator can be used to adjust the forces applied to a user's cranial structure by multiple force transmission structural 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. Multiple hydraulic force generators can also be used in situations where the device is required to apply different force characteristics simultaneously. The hydraulic force generators can be separate units and can be connected or provided together in a single housing / single sealed unit.

[0022] The above disclosure of the present invention is general and does not relate to the application of cyclic forces to specific cranial structures. Reference will now be made to some specific applications of the device.

[0023] In some embodiments, the device is configured to perform maxillary or mandibular expansion, which can refer to widening of the dental arch through tooth movement or widening through displacement of naturally occurring bone segments, and can be performed using a device or surgically, such as by separating sutures. In this case, the first and second forces result in outward bending of the jaw and expansion of the upper and lower surfaces of the mouth, i.e., reducing the curvature of the mandible or maxilla. It will be appreciated that structures configured to receive forces (directly or indirectly) from such devices can receive the forces as compression or tension. There are many different ways in which maxillary expansion can be achieved using the devices of the present invention. In some embodiments, the first and / or second anchor points can be teeth. For example, the first and / or second anchors can include wires, bands, or other orthodontic fixtures configured to wrap around teeth, or plates / wires configured to abut or engage the inner or outer surfaces of teeth. In embodiments in which the first and second anchor points are the first and second teeth, respectively, it is preferred that the first tooth be symmetrically opposed to the second tooth in the user's mouth. In some embodiments, the first anchor and / or the second anchor may comprise a molded plate shaped to conform to the inner surface of the user's teeth to provide a snug fit for more efficient force transmission. Alternative anchor placements may also be used depending on the shape of the dental arch and the desired clinical outcome. In some embodiments, the first anchor and / or the second anchor may comprise a combination of the features described above. In other embodiments, the first anchor and / or the second anchor may be a location on the soft tissue of the user's mouth. In such embodiments, the first and / or second anchor may comprise a screw or equivalent fastener configured to directly contact bone or soft tissue. More direct tissue contact enables more efficient force transmission.

[0024] According to exemplary embodiments, the device may be in the form of or include an expansion mechanism that can be configured to perform maxillary or mandibular expansion. The expansion mechanism may be configurable to be positioned in a substantially central position on the upper surface of the user's mouth. The expansion mechanism may include a central component, a hydraulic component, a channel component, and an attachment component. According to exemplary embodiments, the central component may be adjusted by turning the threaded portion relative to the channel component to apply a constant force to the patient's cranial structure via the attachment component. This force defines a background static force. Then, in use, the hydraulic component is cyclically inflated and deflated using an external hydraulic force generator. When the hydraulic component is inflated, it applies an additional force to the user's cranial structure via the attachment component. The additional force may be a cyclic force. When this occurs simultaneously, the region of the user's cranial structure located between the two attachment components is subjected to a distraction force, facilitating maxillary expansion.

[0025] The central component can be configured to be displaced relative to the channel components. Alternatively, the central component can be configured to cause separation between the first channel component and the second channel component. The central component can comprise an elongated member having a threaded portion configured to be received within a threaded bore of the channel component. The elongated member can be configured such 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. Thus, the elongated member can be configured to apply a static force to the channel component configured to engage with the threaded portion. The elongated member can comprise first and second threaded portions disposed at opposite ends of the elongated member and configured to engage with each of the first and second channel components, respectively.

[0026] The central component can further include an alignment rod extending between the first and second channel components, and the alignment rod can be configured to maintain alignment of the channel components when the channel components move relative to one another by rotation of the threaded portion. The central component can include two or more alignment rods. The first and second alignment rods can be located on each side of the elongated member to ensure that the components are precisely aligned.

[0027] The alignment rods can be cylindrical (i.e., have a circular cross section). It will be appreciated that the alignment rods can be configured to have any one of a square, rectangular, oval, and hexagonal cross section, or any other suitable shape. The alignment rods can be configured to have a rounded rectangular cross section, including, for example, an obround cross section.

[0028] The channel component can be configured (i.e., shaped and / or arranged) to accommodate the hydraulic component. The channel component can include one or more holes configured to receive the end of a central portion alignment rod. The hydraulic component can include an inflatable structure such as a balloon. The inflatable structure can include an elongated, substantially cylindrical balloon including a conical or frustoconical tip at its distal end. The proximal end of the balloon can be connectable to a tube, hose, or catheter configured to supply hydraulic fluid to the balloon. When the balloon is in place within the channel component, the outer edge of the balloon can be aligned with or extend beyond the outer wall of the channel component.

[0029] The attachment component can be configured to attach the expansion mechanism to a patient's cranial structure. In particular, the attachment component can be configured to attach at least one of the channel component and the central component to the cranial structure. The attachment component can include a shaped structure shaped to match the contours of the patient's palate and / or teeth to form a snug fit therewith. The attachment structure can include fasteners detachable from the shaped structure, for example, to enable a single expansion mechanism to be removably attached to a variety of different shaped structures and accessories. The attachment component can include fastening means configured to attach the expansion mechanism directly to the cranial structure. The fastening means can include one or more bone screws. In this manner, the attachment component can define at least one of the first and second anchors. The screw can include a rounded or domed head portion configured to avoid any sharp edges that could damage soft tissue. The top surface of the domed screw can include a hexagonally shaped hole or recess, which can be configured to enable the screw to be turned with a hexagonal tool.

[0030] The attachment component can include a wing or leg extending from the body of the attachment component. The wing can include a hole configured to receive a fastening means. The hole can include a locating slot configured to releasably couple the wing to the screw. The locating slot can include two intersecting circular holes or bores. The first, larger hole can be configured to be larger than the diameter of the head portion of the screw. The second, smaller hole can be configured to be larger than the diameter of the shaft portion of the screw and smaller than the diameter of the head portion of the screw. The first hole can be sized to allow the head portion of the screw to pass through the first hole. The second hole can be configured to receive the shaft of the screw when the attachment component is positioned in its desired portion in the user's mouth. The underside of the dome-shaped screw can be configured to engage a chamfered edge of the second hole of the locating slot. The wing can be substantially aligned with the base of the body, and the wing can be configured to extend away from the base of the body along a plane substantially parallel to the base of the body. The wing portions can be integrally formed with the body of the attachment component. The attachment component can include a plurality of wing portions. The wing portions can be located at distal corners of the body of the attachment component. The attachment component can be integrally formed with the channel component.

[0031] A cover can be positioned to form a protective shield over at least a portion of the expansion mechanism. The cover can be positioned to shield at least one of the hydraulic component, the mounting component, and the core component. The cover protects the patient's soft tissue from direct contact with features of the expansion mechanism. For example, the cover can be positioned to prevent the patient's tongue from contacting the moving component of the expansion mechanism. For example, the hydraulic component can be configured to cause cyclic displacement of the moving component when in use, which could cause injury or discomfort to the patient.

[0032] In other similar embodiments, the device can be used to perform anterior expansion of the maxilla or mandible, i.e., forward growth of the upper or lower jaw, for example, to correct an underbite or overbite. In embodiments where the device is intended for anterior expansion of the mandible, the device can include a portion having components arranged to connect to bone screws attached to the inner surface of the mandible. In some embodiments, the first and second forces result in growth and / or displacement and remodeling of the upper and lower surfaces of the mouth and the upper and lower surfaces of the maxilla / mandible themselves in the anterior-posterior (anterior-posterior) direction. In these embodiments, the first anchor point can be one or more teeth. In such cases, the first anchor can be in the form of a wire, band, or other orthodontic fixture configured to wrap around one or more teeth, or a plate or wire configured to abut or engage the back surface of an anterior tooth. Alternatively, the first anchor can include a molded plate shaped to fit against the back surface of the tooth to provide a snug fit for more efficient force transmission. The second anchor point can be a point on the soft tissue of the user's upper or lower palate posterior to the first anchor point, and can include a screw or equivalent fastener configured to directly contact bone, teeth, or soft tissue. More direct tissue contact enables more efficient force transfer.

[0033] In the embodiments described above, there are two primary means by which the force generated by the force generator can be usefully transmitted to the first anchor and the second anchor. As outlined above, the force transmission structure can be in the form of a hydraulic force transmission structure. Alternatively, an approach involving solid components configured to convert one type of motion to another can be used, i.e., no hydraulic components are used. Throughout this application, this will be referred to as a mechanical force transmission structure. In some embodiments, there can also be a hybrid of both hydraulic and mechanical force transmission structures.

[0034] As discussed above, the periodic force is preferably maintained or converted into an anterior-posterior force. However, to produce primarily lateral or lateral maxillary or mandibular expansion, the periodic force (and any optional static component) of the force must be lateral. Therefore, the force transmission structure preferably includes a mechanism for rotating the direction of the force by approximately 90°. As used herein, "approximately 90°" should also be interpreted to encompass exactly 90°. In addition, in some embodiments, the force must be transmitted to both the first anchor and the second anchor. The force transmission structure may include a mechanism for converting the periodic force into a first force that is approximately 90° relative to the periodic force and a second force that is approximately 90° relative to the periodic force but opposite in direction to the first force. The force transmission structure preferably includes a first force transmission component positioned to transmit the periodic force from the force generator to the anchor, the first force transmission component including 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 in the form of a periodically oscillating linear tension using a thread. Specifically, the mechanism can be configured to convert the linear reciprocating motion into an oscillating rotational motion of the rotating component. The rotating component can include a first thread. The mechanism can further include a first threaded member, the first threaded member having a second thread at least at a proximal end, the second thread being complementary to and engaged with the first thread. The distal end of the first threaded member preferably contacts the first anchor. The rotating component and the first threaded member are preferably arranged such that engagement between the first and second threads converts rotation of the rotating component into a reciprocating linear motion of the first threaded member. This reciprocating linear motion then transmits the periodic force to the first anchor. The rotating component can have a third thread in an opposite sense to the first thread, and the mechanism can include a second threaded member having a fourth thread that is complementary to and engaged with the third thread. The mechanism can further include a second threaded member having a third thread in an opposite sense to the second thread.The distal end of the second threaded member preferably contacts the second anchor. The rotating component and second threaded member are preferably arranged such that engagement between the third and fourth threads converts rotation of the rotating component into reciprocating linear motion of the second threaded member. This reciprocating linear motion then transmits a cyclic force to the second anchor. Alternatively, the same effect can be achieved by providing a first rotating component and a second rotating component. In other embodiments, the mechanism can include one or more worm and pinion gears or a ball and socket connection to achieve the same effect.

[0035] Other embodiments employ a hydraulic transmission structure including one or more expandable structures, such as balloons, 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 throughout the channel or chamber, thereby causing inflation or collapse of the expandable structure. In some embodiments, a first expandable structure is rigidly connected to a first anchor (e.g., by a first rod or other rigid body), and a second expandable structure is rigidly connected to a second anchor (e.g., by a second rod or other rigid body). Here, the expandable structures can be continuous (i.e., in fluid communication with each other) or can be separate components detachably or permanently attached to separate rigid bodies. Here, rigidly connected should be understood to mean that the two features are connected by a non-flexible and / or non-compressible connector. The expandable structures can be located within a groove or channel. When the first and second expandable structures are expanded, an expansion force (i.e., a cyclic force transmitted by, for example, a piston) is transmitted to the first and second anchors, respectively. Alternatively, a single expandable structure can be rigidly connected to both the first and second anchors, such that expansion of the single expandable structure transmits a cyclic force to both the first and second anchors. The or each rod can be cylindrical (i.e., have a circular cross-section). Alternatively, the rods can each include a cross-section of any one of square, rectangular, oval, and hexagonal, or any other suitable shape. The or each rod can be configured to have a rounded rectangular cross-section.

[0036] Using a hydraulic transmission structure such as that described in the preceding paragraph, the direction of the cyclic force can be more easily changed by proper orientation of the rigid connectors and inflatable structures. For example, the hydraulic transmission structure can be used for maxillary / mandibular expansion, anterior expansion, or maxillary / mandibular lengthening by proper placement of the inflatable structures and rigid connectors. Throughout the above, it should be understood that the term "rigid" means that a component, such as a connector, is incompressible over the length of the device, thereby ensuring that a force applied to one of the components is substantially equal to the force transmitted to the opposite end of the component.

[0037] In other embodiments, the expandable structure can directly contact the first anchor and / or the second anchor. Alternatively, the first anchor and / or the second anchor can be formed from the expandable structure. For example, the device can include multiple expandable structures, each configured to abut or engage with 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 include a shaped structure or plate, one or more expandable structures can be located on an outer surface of the shaped structure configured to face, abut, or engage with an inner or outer surface of a tooth. It will be appreciated that one or more expandable structures can be located on any surface of the shaped structure. It will be appreciated that the shaped structure can define a structure configured to conform to a corresponding surface of the patient's mouth, such as a portion of the palate and / or the inner surface of a tooth, and / or a bone interface.

[0038] The shaped structure can be configured to be secured to the upper jaw of a user's mouth during use using fastening means, such as bone screws. In this manner, the fastening means can define at least one of first and second anchors, as described above. At least one of the shaped structures can be configured to engage the fastening means to secure the shaped structure to a patient's cranial structure. The shaped structure can be configured with holes or apertures arranged to receive fasteners, such as bone screws. The apertures can be located at edges of the shaped structure and can be configured to open at least partially laterally. In this manner, the apertures can enable the shaped structure to be slidably engaged with fasteners fixedly attached to the patient's cranial structure. According to an exemplary arrangement, the shaped structure can be shaped to fit the contours of the patient's palate, and the shaped structure can include an aperture located at an inner end of the shaped structure, the aperture configured to receive a fastener when moved inwardly when the shaped structure is placed in the patient's mouth.

[0039] The shaping structure may include one or more shaping plates. According to an exemplary arrangement, the shaping structure may include a central shaping plate and peripheral shaping plates. Each of the shaping plates may be shaped to conform to a corresponding (i.e., selected) surface of the user's mouth, such as a portion of the palate and / or the inner surfaces of the teeth. An inflatable structure, such as a balloon, may be disposed at the junction between the central shaping plate and the peripheral shaping plate. The junction between the central shaping plate and the peripheral shaping plate may define a channel in which the inflatable structure is disposed. The channel may be tapered (i.e., configured such that the width of the channel narrows along the junction between the two shaping plates). The tapered channel may narrow from the anterior portion to the posterior portion of the shaping plate. In this manner, the tapered channel may be configured to cause greater expansion of the inflatable structures in wider portions than in narrower portions. The greater the relative expansion of the inflatable structures, the greater the rotation of the shaping structures relative to each other.

[0040] The expandable structure can be configured to couple the joints by being inflated and / or deflated with hydraulic fluid. The expandable structure can be deflated or at least partially expanded to facilitate access to fastening means configured to secure the shaped structure to the user's mouth. Additionally or alternatively, the expandable structure can be expanded to stiffen the joints. Thus, expansion of the expandable structure brings the peripheral shaped plate into intimate contact with the surface of the user's mouth, and the peripheral shaped plate is shaped to conform to the surface of the user's mouth. In this manner, the peripheral shaped plate can be configured to transmit forces generated by the expandable structure to the user's mouth. Thus, the peripheral shaped plate can define at least one of the first and second anchors, and the expandable structure can define at least a portion of the hydraulic force transmission structure. By inflating the expandable structure between the central shaped plate and the peripheral shaped plate, the device can be configured to affect expansion of the upper or lower jaw of the user's mouth. The channel at the joint between the central shaped plate and the peripheral shaped plate can include a substantially straight portion. In use, the straight portion can be positioned at an angle relative to the midline of the patient's mouth. The joints between the shaped plates can include curved portions, and the curvature can be configured to at least partially follow the curvature of the plane of the tongue. When the device includes first and second peripheral shaped plates disposed on either side of the central shaped plate, the channels between the respective plates can be configured to be substantially parallel to each other.

[0041] It will be appreciated that in the above-described arrangement, the inflatable structures can be configured to enable relative movement between the central shaped plate structure and the peripheral shaped plate structure. Each inflatable structure can be formed from a flexible material configured to allow relative displacement of the plates in the lateral and / or vertical directions. The enhanced flexibility provided by the inflatable structures means that the peripheral shaped plates can be displaced laterally and even rotated relative to the patient's mouth during use. In this manner, the resulting movement of the peripheral plates allows them to conform to the shape of the patient's mouth, thereby reducing patient discomfort.

[0042] Furthermore, the above-described combination of expandable shaped plate structures allows the device to accommodate asymmetric expansion of a patient's cranial structures. For example, such a device can accommodate outward rotation of the hemimaxilla caused by greater posterior resistance of adjacent structures. In addition, the device can accommodate differences in the relative expansion of the cranial structures (e.g., one hemimaxilla can rotate more than the other), thereby ensuring that efficient force transmission is maintained.

[0043] According to an exemplary embodiment, the first anchor can be defined by a fastening means configured to secure the central shaped plate to the user's mouth, and the second anchor can be defined by a portion of the peripheral shaped plate shaped to conform to the surface of the user's mouth. In an alternative embodiment, the shaped structure can include an additional peripheral shaped plate positioned opposite the central shaped plate. With this arrangement, the first and second peripheral shaped plates can both be configured to transmit opposing forces to either side of the user's mouth, thereby defining the first and second anchors, respectively.

[0044] According to an alternative aspect of the present invention, the expandable structure can be disposed at a junction between two structural elements. At least one of the structural elements can define an elongated member configured to extend longitudinally from the junction. The other of the two structural elements can be a shaped structure configured to conform to the shape of the patient's cranial structure. Alternatively, the first and second structural elements can each comprise an elongated member. A free end of the elongated member can be attached to the patient's cranial structure. In this manner, the free end of the elongated member can define at least one of the first and second anchors, as described above. The elongated member can be movably fastened to the other structural element by a bolted clasp arrangement, and the expandable structure can be received through a central opening of the clasp arrangement.

[0045] In particularly preferred embodiments, the device includes a shaped structure or plate, preferably shaped to fit the user's mouth. The shaped structure can include recesses shaped to fit the user's teeth. The recesses can be located on a surface of the shaped structure that is positioned to contact at least one of the inner, outer, buccal, labial, lingual, and occlusal surfaces of the teeth. The shaped structure can include multiple recesses, each shaped to fit multiple teeth of the user. One or more of the multiple recesses preferably include a cantilever structure.

[0046] It will be appreciated that the recesses can correspond to two or more teeth. The recesses can include cantilever structures configured to engage with the user's teeth when the appliance is in place in the user's mouth. The surfaces of the cantilever structures can be shaped to contact the surfaces of the user's teeth. The cantilever structures can be positioned to contact, oppose, abut, or engage with any surface of the teeth. For example, the cantilever structures can be configured to contact at least one of the inner, outer, buccal, labial, lingual, and occlusal surfaces of the teeth.

[0047] Additionally, the device preferably includes a channel or groove and an expandable structure housed within the channel, the channel being located immediately behind the cantilever structure. The channel can be arranged within the device to define an internal channel. The channel can be arranged within a molded structure of the device. Thus, the channel is preferably curved to match the curvature of the dental arch. The expandable structure is preferably arranged to apply a force to the cantilever structure when expanded, which acts to bend the cantilever structure. Thus, in use, when the expandable structure is expanded, the force applied to the cantilever structure is applied to a tooth located within the recess, which acts to cause tooth movement. In this manner, the cantilever structure can define a first anchor, and the tooth can define a first anchor point. The second anchor can be defined by the second cantilever structure. Alternatively, the second anchor can be defined by an expandable structure configured to directly contact a cranial structure, such as a tooth.

[0048] In an exemplary arrangement, the first cantilever structure can be configured to contact a first tooth surface, and the second cantilever structure can be configured to contact a second tooth surface. The first and second tooth surfaces can each define an inner or outer surface of the tooth. For example, the first and second cantilever structures can be configured to contact two different surface portions of the tooth. The first and second cantilever structures can be configured to apply separate forces to each of the first and second surface portions of the tooth. The second cantilever structure can be configured to apply a force independent of the first cantilever structure. By configuring the first and second cantilever structures to apply forces independent of each other, the device can be operable to achieve further control of the force applied to the tooth by the cantilever structures. For example, the first cantilever structure can be configured to apply a first force, and the second cantilever structure can be configured to apply a second force, where the first and second forces include different magnitudes and directions. The first and second cantilevers can be configured to apply a non-uniform force to the tooth to cause translation and / or rotation of the tooth.

[0049] The first expandable structure can be configured to apply a force to the first cantilever structure and the second expandable structure can be configured to apply a force to the second cantilever structure, in this manner the expansion of the first and second expandable structures can be controlled to determine the respective forces applied by the first and second cantilevers.

[0050] The cantilever structure can define an elongated cantilever finger, the cantilever finger including a first end attached to the forming structure and a second end not attached. The unattached end can be movable relative to the forming structure to enable the cantilever finger to bend. It will be appreciated that the cantilever structure can define any structure having a fixed end and a movable end (i.e., the movable end is movable relative to the fixed end). The cantilever finger can have a fixed end that is wider than its free end. The cantilever finger can be configured to taper toward the free end.

[0051] The recess can be positioned in close contact with the tooth surface or at a distance from the tooth surface, and can be positioned at different orientations, such as at an angle. Furthermore, the recess can comprise two or more sections. In one embodiment, a first section can be positioned at a first location on the tooth close to the gum line, and a second section can be positioned at a second location substantially away from the gum line. A single cantilever structure can be housed within the first and second sections of the recess. The first and second sections of the recess can be interconnected. In some embodiments, two or more cantilever fingers can be provided. Each of these sections can be naturally positioned at slightly or substantially different angles and molded onto one or more teeth. Alternatively, each of the sections can be designed to be positioned at a substantially different angle; for example, a single cantilever finger can be oriented substantially in a plane inclined upward or downward (relative to its adjacent section or the vertical axis) passing through the local longitudinal axis of the balloon.

[0052] The area of ​​each of the sections containing the cantilever fingers can vary; for example, thicker cantilever fingers will bend less when subjected to force than thinner fingers. Reducing the bending of the fingers can allow for less force to be transmitted to the tooth or teeth of the pair; therefore, varying the thickness of the fingers throughout the device should allow for varying the application of force to the teeth when using a single expandable structure. The fingers and / or their adjacent sections can be made from materials of varying stiffness. Furthermore, one, multiple, or zero fingers can contact a single tooth or a group of teeth. Single or multiple internal channels can be provided, with multiple internal channels housing multiple expandable structures.

[0053] The following features can also be varied for the cantilever structure: · The plane of application of the cantilever structure, i.e., angle. The area of ​​applied force, i.e., the top of the tooth, the middle of the tooth, or along the gingival margin Length and number of fingers per tooth Fingers / Different material hardness · Many balloons in series or parallel.

[0054] Additionally, the tunnels / grooves / channels can be continuous or discontinuous across the midline. The shape, circumference, length, and path of the tunnels can vary. The device can accommodate multiple tunnels or channels along with multiple balloons. The channel can be partially or fully segmented to accommodate one or more balloons.

[0055] Additionally, the internal channels can also vary in multiple ways, for example, in path, length, circumference, continuity, ie, communicating across a gap such as between two sections.

[0056] It will also be apparent that by varying the properties of the components described above, a particular tooth or teeth can be completely or relatively relieved from the application of forces.

[0057] In embodiments, the cantilever structure can be defined as an intermediate structure disposed between the expandable structure and the patient's cranial structure. Alternative intermediate structures can include a slide member or a dipper-shaped member. In situations where the intermediate structure includes a dipper-shaped member, the dipper-shaped member can include a dipper-shaped portion that defines a recess in the shaped structure shaped to fit against the tooth surface.

[0058] The intermediate structure can be defined by a weakened portion of the tooth-facing surface or wall of the recess of the forming structure. In this manner, the tooth-facing wall of the recess can include a scored or perforated area to reduce its stiffness relative to the surrounding recess wall. The weakened surface portion can be defined by two or more cantilever fingers extending across an opening in the recess wall. Each of the cantilever fingers can be connected to another cantilever finger to form a flexible lattice arrangement. The lattice of cantilever fingers can define a cross-shaped arrangement.

[0059] Each of these alternative intermediate structures can be configured, for example, to receive force from the expandable structure and transmit that force to the teeth. In use, when the expandable structure is expanded and thus expands outward, its outer surface can exert pressure on the inner surface of the intermediate structure, pressing the outer surface of the intermediate structure against the tooth surfaces, thus causing tooth displacement and maxillary expansion.

[0060] It will be appreciated that the intermediate structure can further define any recesses or tooth-receiving portions of the shaped structure, which can be configured to be positioned between the expandable structure and the surface of the user's teeth when in use and to transmit forces therebetween. Such intermediate structure can necessarily be configured to contact any surface of the teeth that can be manipulated to effect tooth displacement. For example, the intermediate structure can be configured to contact at least one of the inner, outer, and occlusal surfaces of the user's teeth.

[0061] In the above-described embodiments, the first anchor, the second anchor, at least a portion of the force transmission structure (preferably the mechanism that converts the cyclic force into a first force at approximately 90° to the cyclic force and a second force at approximately 90° to the cyclic force but opposite in direction to the first force, or the inflatable structure) is preferably sized to fit inside the user's mouth. Such an arrangement can be referred to as an intraoral appliance, since the majority of the device is located in the user's mouth during use. This is advantageous because it allows for a more compact device. It should be appreciated that intraoral also encompasses any combination of balloon arrangements, such as balloons in opposing positions on either side of a tooth contacting a group of teeth, whereby the balloons, and their expansion, cause tooth retraction and retraction of a balloon located above the gums, for example, in the maxilla. The same principle applies to the skull. In embodiments where the device includes a hydraulic force transmission structure, the change in force direction can be determined by the shape of the inflatable structure used.

[0062] In some embodiments, the appliance may include a shaped plate that is shaped to conform to the surface of the user's teeth, hi some embodiments, the shaped plate preferably conforms to the surface of the user's teeth in a flush manner to ensure maximum force transmission.

[0063] The molded plate can be shaped to fit the inner surface of the tooth, the uppermost portion of the tooth, 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 a tipped tooth, the outer section of the molded plate acts as a "rotation stop" that limits further tipping and eventual uprighting of the tooth. The device can produce translation when used on teeth that are already in the correct plane, i.e., not tilted. By minimally increasing the distance between the outer wall of the molded plate and the outer surface of the tooth, the device can accommodate both tipping and uprighting of the tooth; that is, tooth movement and tipping can occur until the tooth contacts the wall, after which uprighting occurs. At this point, if further expansion is desired, a separate device can be molded. It will be understood that one or more of the recesses can have these features to a lesser or greater extent, or can be completely lacking; for example, the wall adjacent to the outer surface of the tooth can be made taller or cantilever fingers can be absent. The reverse arrangement can also be used to "push" the tooth "inward."

[0064] However, in some embodiments, the additional effect of preventing or correcting tooth tilting can be achieved if the molding plate is shaped to fit the teeth only at the top of the teeth, with the distance between the inner surface of the molding plate and the surface of the teeth increasing with distance from the top of the teeth. Alternatively, the molding plate can be shaped to fit the teeth only at the bottom of the teeth, with the distance between the inner surface of the molding plate and the surface of the teeth increasing with distance from the bottom of the teeth. In this way, when the appliance is used to produce, for example, maxillary expansion, after movement of the top of the teeth, an outward force is applied only to, for example, the bottom of the teeth, to correct, for example, the tilt of the teeth.

[0065] In other words, the molded plate can be shaped to fit the inner surface, the top portion (tip), and part 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 section of the molded plate acts as a rotation stop that limits further tilting and eventual upsetting of the tooth.

[0066] When used on teeth that are already in the correct plane, i.e., not tilted, the appliance can cause translation by limiting or preventing any rotational movement.

[0067] In this regard, if further expansion is desired, another device can be molded. It will also be understood that one or more of the recesses can have these features to a lesser or greater extent, or can be completely lacking, e.g., the wall height adjacent the outer surface of the tooth can be greater, or cantilever fingers can be absent. The reverse arrangement can also be used to push the tooth inward or medially, i.e., toward the center of the mouth. An illustrative drawing of the geometry of the cantilever structure is shown in FIG. 37.

[0068] In the above-described embodiment, the cranial structure being remodeled is located between a first anchor point and a second anchor point. However, the underlying principles of the present invention apply equally well when the cranial structure to be altered is not between two anchor points. Accordingly, a second aspect of the present invention provides a cranial remodeling device for expanding, compressing, or bending a cranial 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 cyclic force; a first anchor for attachment to the first anchor point; and a force transmission structure connected to the force generator and configured to transmit the cyclic force to the first anchor in a remodeling direction, the head support including limiting means configured to prevent or limit movement of the user's head in the remodeling direction when the cyclic force is applied. In a very simple arrangement, the second aspect of the present invention can be realized by an arrangement in which the force generator is connected via one or more wires to one or more bone screws in position, e.g., in the lateral wall of the maxilla, via the force transmission structure, and a vibration force is applied. In such cases, as discussed in more detail below, the restraining means may be in the form of a friction providing device, or may simply be the weight of the user's head, preventing vibration of the head as a result of inertial mass. Fixation straps may also be utilized to stabilize the head.

[0069] Where suitable, the optional features described above with reference to the first aspect of the invention are equally well applicable to the second aspect of the invention and will not be repeated here for brevity. In these embodiments, the head support includes a limiting means that prevents the cyclical force from causing displacement of the user's entire head or the device alone. In other words, the limiting means receives at least one component of the response to the cyclical force. Examples of limiting means are discussed in more detail below. The device of the second aspect of the invention is particularly useful for maxillary distraction.

[0070] The device can take the form of a cradle device including a head support and rails. The head support is preferably configured to be fastened around the user's head, preferably with a force applied against the sides of the user's head and face. This means that friction between the user's head and the inner surface of the head support acts to prevent forward and backward movement of the user's head when a forward and backward force is applied. The rigidity of the structure and its securing mechanism also helps to resist sideways movement when a lateral force is applied. In other words, in such an embodiment, the inner surface of the side of the head support is insulated from at least a portion of the restricting means. More generally, the restricting means can be said to be configured to frictionally restrict or prevent movement of the user's head. To be effective, the frictional force generated by contact between the user's head and the inner surface of the head support should be greater than the cyclic force applied to the first anchor point.

[0071] Alternatively, the limiting means may include an abutment surface configured to abut against the user's head in use, wherein contact with the abutment surface is configured to prevent or limit movement of the user's head in the reconfiguration direction, hi some embodiments, the weight of the user's head alone may provide the limiting means.

[0072] The rail is preferably connected to the head support by one or more connectors. In such embodiments, the force generator can be in the form of a motor connected to both the head support and the proximal end of the connector. Alternatively, the force generator can be in the form of a hydraulic pump, which is also connected to the proximal end of the connector. In some embodiments, the first and second force generators can be connected to the rail by first and second connectors, respectively. The rail is preferably attached to the distal end of the one or more connectors. The rail and the first and / or second connectors can form part of a force transmission structure, which can further include one or more additional connectors, e.g., a third connector, the proximal end of which is preferably attached to the rail, and the distal end of which includes a first anchor, as previously discussed in this application, configured to be attached to the first anchor point. The first anchor point may be in the form of a tooth, maxilla, mandible, part of the occlusal plane, zygomatic arch, top of the skull, nose, or other structure.

[0073] In the case of symmetric extension, the device preferably includes a second anchor for connecting to a second anchor point on the cranial structure. The device may further include a fourth connector, the fourth connector including a second anchor at its distal end. The second anchor point may be any of the same cranial structures listed in the preceding paragraph with respect to the first anchor point.

[0074] In some embodiments, the device can include multiple rails, thus enabling simultaneous extension of two or more cranial structures. Preferably, at least one, and preferably a pair, of the force generators associated with each of the multiple rails is connected to the rail via a connector.

[0075] In some embodiments, the height of the rails can be varied, where "height" refers to a range in the upward-downward direction. In this way, one device can be used to generate reconstructions of different cranial structures, without the need for an entirely different device. To achieve this, one or more connectors can be rotatably attached to the head support, so that an assembly including one or more connectors and rails can be rotated to a desired position for cranial reconstruction. Alternatively, the assembly, including at least the connectors and rails, and preferably also one or more force generators, can be translated in the upward-downward direction, for example, on a dedicated structure. In some embodiments, rails can be attached to the assembly, and the assembly can be rotated and translated on the rails to allow for even greater flexibility of movement.

[0076] In some embodiments, the limiting means can be located on a rail. Preferably, the limiting means is movable along the rail so that it can be positioned in the optimal position for the particular skull reconstruction being performed. Multiple limiting means can be provided, for example to ensure symmetrical movement.

[0077] The present invention also encompasses devices that can be used for cranial compression. While embodiments of several aspects of the present invention described above can be used to perform compression, most of these embodiments are directed to systems that apply tension to cranial structures. A third aspect of the present invention provides a cranial compression device that includes a head support unit configured to apply a compressive force to at least a portion of a user's skull, a force generator configured to generate a cyclical force, and a force transmission structure configured to transmit the cyclical force to the user's skull.

[0078] In some embodiments of the third aspect of the present invention, the head support includes or is in the form of a helmet, the inner surface of which is shaped or molded to fit the outer surface of the user's head. Molding the helmet to closely fit the shape of the user's head can ensure a tight fit, thereby applying roughly equal compression to the user's skull in all directions during use. Regions can be omitted to limit the application of force to specific areas of the head. Embodiments of the third aspect of the present invention are likely to be used to correct specific cranial deformities, which require applying compressive forces in specific directions to specific portions of the user's skull. Benefits can also be achieved by acting on soft tissue structures. Therefore, it is highly preferred that the head support include a first portion positioned over the cranial structure and a second portion positioned opposite or substantially opposite the cranial structure. It should be understood that "opposite" means that the first and second portions are located on opposite sides of the user's skull during use. This ensures that when a compressive force is applied to the cranial structure by the first portion, the second portion is able to provide the necessary counterforce to maximize the effect of the compressive force.

[0079] In some embodiments, rather than the head support being in the form of a molded helmet, the head support can include first and second sections movable relative to one another and means for connecting the first section to the second section such that the inner surfaces of the first and second sections are configured to apply a compressive force to the user's skull. In some embodiments, the first and second sections can be joined to one another as a hinge. The first and / or second sections can then include locking means for securing the first and second sections in regions opposite the hinge. For example, the first section can be shaped to receive the back of the user's head, so that the user can lie on their back with their head resting on the first section. The hinge can be located in a region corresponding to the crown of the user's head, so that after the user places their head in position on the first section, the second section can be lowered onto their head (i.e., pivoted about the hinge) and connected to the second section via suitable locking means.

[0080] In other embodiments, the head support can further include a third section, with the second and third sections connected to the first section via a hinge. Similar to the embodiment described in the previous section, the first section can be shaped to receive the back of the user's head, allowing the user to lie on their back with their head resting on the first section. The hinges can be located in areas corresponding to the left and right sides of the user's head, allowing the user to place their head in position on the first section, and the second and third sections can be raised around the sides of the user's head and secured together via suitable locking means. This can be used, for example, to compress the user's skull laterally. These embodiments can also easily use hydraulic elements to actuate other components, as well as apply force directly to anchor points, for example, by including an inflatable structure on the surface of the structure that contacts the skull.

[0081] Like the force transmission structures of the previous aspects 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 balloons or bellows, positioned on the inner surface of the head support at locations corresponding to the cranial structures. The force generator is preferably configured to cyclically inflate and deflate the one or more inflatable structures to superimpose a cyclic force on the static compressive force applied by the head support.

[0082] The previous three aspects of the invention have focused on the periodicity of the force. However, the inventors have noted that advantageous effects can be provided by devices capable of applying a force (e.g., a constant force, a continuous force, a decaying force, or a periodic force as previously defined in this application) using a hydraulic force transmission structure. The use of a hydraulic force transmission 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 invention focus on devices that apply a constant or other general force using a hydraulic force transmission structure. It will also be understood that all aspects, including electromechanical variations, can be used to generate a constant force as well as a continuous, i.e., constant rate, of displacement.

[0083] Accordingly, a fourth aspect of the present invention provides a cranial remodeling device for expanding, compressing, or bending a cranial structure located between a first anchor point and a second anchor point, the device comprising: a force generator configured to generate a force; a first anchor for attachment to the first anchor point; a second anchor for attachment to the second anchor point; and a hydraulic force transmission structure connected to the force generator and configured to transmit a cyclic force to the first anchor and the second anchor, thereby placing the cranial structure in at least one of tension, compression, or flexion.

[0084] A fifth aspect of the present invention provides a cranial remodeling device for expanding, compressing or bending a cranial 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 force; a first anchor for attachment to the first anchor point; and a hydraulic force transmission structure connected to the force generator and configured to transmit a cyclic force to the first anchor in a remodeling direction, the head support including a limiting means configured, in use, to prevent or limit movement of the user's head in the remodeling direction when the cyclic force is applied.

[0085] A sixth aspect of the present invention provides a skull compression device including a head support unit configured to apply a compressive force to at least a portion of a user's skull, a force generator configured to generate the force, and a hydraulic force transmission structure configured to transmit the cyclic force to the user's skull.

[0086] Those skilled in the art will appreciate that the optional features already described in this section with respect to the first, second and third aspects of the invention may also be applied to the fourth, fifth and sixth aspects of the invention. Those skilled in the art will particularly note that the optional features of the first aspect of the invention are also particularly (although not exclusively) applicable to the fourth aspect of the invention, the optional features of the second aspect of the invention are also particularly (although not exclusively) applicable to the fifth aspect of the invention, and the optional features of the third aspect of the invention are also particularly (although not exclusively) applicable to the sixth aspect of the invention.

[0087] The device according to the present invention can be made entirely from MRI compatible materials, such as polymers and / or non-magnetic materials, thus allowing the device to be utilized by a user who is simultaneously undergoing an MRI scan.

[0088] It should be noted that in some cases, two or more devices according to any embodiment of any aspect of the invention can be used in conjunction with one another to provide cranial reconstruction. For example, subjecting the maxilla to tension using an embodiment of any of the first and fourth aspects of the invention can be performed during the same routine as cranial compression. The devices of the invention are preferably programmable to work synchronously and / or simultaneously.

[0089] The present invention will now be described with reference to the accompanying drawings. [Brief explanation of the drawings]

[0090] [Figure 1] 1A and 1B are diagrams showing an example of an upper jaw expansion device. [Figure 2] 2A and 2B show an example of an alternative maxillary expander device. [Figure 3] 13A-13C show an example of another alternative maxillary expander device. [Figure 4] 13A-13C show an example of another alternative maxillary expander device. [Figure 5] FIG. 1 shows an example of a similar device used for mandibular expansion. [Figure 6] 6A and 6B show examples of alternative maxillary expander devices. [Figure 7] 7A, 7B, and 7C show examples of alternative maxillary expansion devices. [Figure 8] Figures 8A and 8B show alternative maxillary expander devices, and Figure 8C shows some options for the various components of the maxillary expander device. [Figure 9] FIG. 1 is a diagram showing an example of a premaxillary expansion device. [Figure 10] FIG. 1 is a diagram showing an example of a premaxillary expansion device. [Figure 11] FIG. 1 shows an example of a maxillary expansion device including two shaped plates and multiple balloons. [Figure 12]Figures 12A and 12B show an alternative maxillary expansion device using multiple balloons. Figures 12C and 12D show an alternative maxillary expansion device including a recess to accommodate cantilever fingers and elongated balloons. Figures 12E-12H show four additional examples of devices for reconstructing the occlusal plane. Figure 121 is an enlarged view of a recess that can be seen, for example, in the device of Figures 12F-12H. Figures 12J and 12K are cross-sectional views of alternative maxillary expansion devices including an expandable structure and a sliding member. Figure 12L is a cross-sectional view of an alternative maxillary expansion device including an expandable structure and a dipper-shaped member. [Figure 13] Figure 13A shows an example of a device that can be used to create maxillary expansion, and Figure 13B shows a balloon that can be used with the device of Figure 13A. [Figure 14] Figure 14A shows a device that can be used to separate the bones of the skull, and Figure 14B shows a close-up of a magnification mechanism that can be used in various embodiments of the present invention. [Figure 15] Figures 15A and 15B are illustrations of alternative magnification mechanisms that can be used in various embodiments of the present invention, and Figures 15C-15E are illustrations of slotted screw hole arrangements. [Figure 16] 16A-16D show examples of devices that can be used for maxillary expansion to minimize or reverse the effects of tooth inclination. [Figure 17] 17A-17C show various means for attaching the device according to the present invention to the body of a user. [Figure 18] FIG. 1 shows an example of a device that can be used for maxillary distraction. [Figure 19] FIG. 20 shows an example of a crossbar structure that can be used in the device of FIG. 18. [Figure 20] 20A and 20B show an alternative crossbar structure that can be used in the device of FIG. [Figure 21] FIG. 10 shows an example of an alternative device that can be used for maxillary distraction. [Figure 22] Figure 22A shows an example of a hydraulic crossbar structure that can be used in a device such as that shown in Figure 21. Figures 22B and 22C show enlarged views of components within the crossbar structure of Figure 22A. [Figure 23] FIG. 10 shows an alternative device that can be used for maxillary distraction, in which there are two levels of attachment points on the skull. [Figure 24] FIG. 10 illustrates an alternative device that can be used for maxillary distraction. [Figure 25] Figures 25A-25C are schematic diagrams of a device where force is transmitted to the zygomatic arch, and Figures 25D-25F are schematic diagrams showing placement of the device between the zygomatic arch and the maxilla. [Figure 26] FIG. 10 illustrates an alternative device that can be used for maxillary distraction. [Figure 27] 27A and 27B show an adjustable device where the attachment point is the nasal bone. [Figure 28] FIG. 10 shows an adjustable device with attachment points to intranasal structures. [Figure 29-32] 29-32B show multiple rail arrangements that can be used for various types of cranial reconstructions. [Figure 33] 33A and 33B illustrate a helmet device that can be used for cranial compression. [Figure 34] 34A-34E illustrate examples of positions in which a user can position their head to receive compression or other types of cranial reconstruction from an external device. [Figure 35] 10A-10C illustrate an alternative device that can be used for cranial compression in the superior-inferior direction. [Figure 36] 36A and 36B are schematic diagrams showing how the device of FIG. 35 can be used. [Figure 37] Figure 1 shows several different geometries of cantilever fingers within recesses. [Figure 38]38A and 38B illustrate Matthews-Tessiers distractors that may be used in conjunction with embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0091] 1A and 1B illustrate one embodiment 100 of the present invention, which can be used to widen the maxilla 102 (shown in an everted position in these figures), but which can equally well be used to widen the mandible. The device includes an extra-oral force generator 104 connected to an intraoral portion 106 via 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 joint 116. A distal end 108d of the connecting rod 108 includes a driver portion 109 configured to rotate the central ball joint 116. The intraoral portion 106 also includes two pairs of laterally extending arms 118a, 118b, and 120a (and additional arms not visible in these figures). Arms 118a, 118b are connected to first and second loops 122a, 122b, respectively, which themselves loop tightly around teeth 124a, 124b. Similarly, arm 120a and the non-visible second arm are connected to third and fourth loops 126a, 126b, respectively, which loop tightly around teeth 128a, 128b. In operation, oscillatory rotation of the motor within extra-jaw force generator 104 causes rotation of distal end 108d of connecting rod 108, and thus driver portion 109, which rotates center ball joint 116 through oscillation. This vibration produces a lateral force on the threads 112, 114, which is transmitted to the laterally extending arms 118a, 118b, 120a and the invisible second arm and loops 122a, 122b, 126a, 126b, exerting a cyclical lateral outward force on the teeth 124a, 124b, 128a, 128b. This lateral outward force can act to displace the teeth and / or widen the maxilla. The device 500 shown in FIGS. 2A and 2B is substantially similar to the device 100 shown in FIGS. 1A and 1B, except that two rods 508, 511 allow for independent force transmission to the teeth 524a, 524b and 528a, 528b. Reference numbers similar to those used in FIGS. 1A and 1B indicate similar features in FIGS. 2A and 2B.Useful effects can also be achieved by continuous rotation rather than oscillating rotation. For example, the device can rotate 90° in 12 hours. The rotation speed can be variable. The device can also be used to provide an inward force by slight displacement of the central mechanism (e.g., to reverse the direction or actuation of the threads 112, 114). Such displacement is well within the purview of one skilled in the art.

[0092] FIG. 3 illustrates an alternative embodiment 200 in which cyclic forces are hydraulically transmitted. The device 200 includes two tubes 202, 204, each connected to an intraoral portion 206. Similar to FIGS. 1A and 1B, 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 loops 212a, 212b, respectively, which themselves tightly loop around teeth 214a, 214b. Similarly, the arms 210a, 210b are connected to third and fourth loops 216a, 216b, respectively, which tightly loop around teeth 218a, 218b. Although not shown in FIG. 3 , tubes 202, 204 are connected at their proximal ends 202p, 204p to a force generator, which may include a pump. Specifically, tubes 202, 204 may contain hydraulic fluid, such that the action of the pump causes back and forth movement of fluid within tubes 202, 204. In some embodiments, the pump may be a manual pump, with an indicator (visual, audible, tactile, or a combination thereof) notifying the user when to use the pump. An adjustable pressure regulator may also be used to regulate pressure generated by irregular user activity. However, in a preferred embodiment, the pump is an automatic, preferably electric or electromechanical, pump. Fluid movement within tubes 202, 204 translates into lateral outward forces on laterally extending arms 208a, 208b, 210a, 210b and loops 212a, 212b, 216a, 216b, exerting cyclical lateral outward forces on teeth 214a, 214b, 218a, 218b. This lateral outward force can act to displace the teeth or widen the maxilla. Figure 4 shows a device 300 substantially similar to device 200 of Figure 2, except that in this case, device 300 is not tethered to the teeth but is attached to the maxillary bone of the mouth via the soft tissue covering the roof of the mouth. In alternative embodiments, the device can also be tethered to the walls of the mouth and / or the teeth.

[0093] FIG. 5 shows a device similar to that shown in FIGS. 1A and 1B, but here the device is shown in place in the mandible rather than the maxilla. The internal channel can cross the midline, e.g., in the form of a flexible connection, or each section can have its own internal channel. Those skilled in the art will understand that the description of FIGS. 1A and 1B applies equally well here. Furthermore, it will be understood that the devices of FIGS. 2A-4 can also be easily modified for use in the mandible rather than the maxilla.

[0094] FIG. 6A shows an intraoral appliance 600 for use in expanding a user's dental arch (shown inverted). The appliance 600 includes a plate 602 shaped to fit the user's palate. The shaped plate 602 includes a plurality of recesses 604 around its periphery, each shaped to fit the surface of a respective tooth. In the appliance 600 of FIG. 6A, there is also an optional structure 606 shaped to wrap around the outer surface of the tooth. The portions of the appliance that are placed in contact with the user's teeth each include a balloon, allowing force to be transmitted to the tooth through openings in the recesses between the balloon and the tooth surface. Specifically, in this case, the force transmitter is hydraulic. In FIG. 6A, an additional section is provided for anchoring to the user's tooth. The appliance 600′ of FIG. 6B is similar to the appliance 600 of FIG. 6A, and like reference numbers indicate like features. In Figure 6B, device 600' further includes two holes 608' positioned to receive screws 610' secured to the user's palate. Device 600' also includes slots 612' shaped to receive screws (not shown) in the user's palate wall. Those skilled in the art will understand that the embodiments of Figures 6A and 6B can be combined and that all of the features shown are optional.

[0095] Figures 7A, 7B, 7C, and 8A show additional examples of devices 700, 750, 760, 800, each including shaped plates 702a&b, 752a&b, 762a&b, 802a&b. The expansion mechanism 704, 754, 764, 804 of each device is shown and described in detail with reference to Figure 8B (see below). Figures 7A, 7B, 7C, and 8A differ in the area over which force is applied in the mouth. In the device 700 of Figure 7A, the force is applied via two plates 702a, 702b that are shaped to fit the inner surface of the palate, ensuring an even distribution of force across the palate and therefore an even expansion. In the device 750 of FIG. 7B, two shaped plates 752a, 752b are provided. The device 750 of FIG. 7B differs from the device 700 of FIG. 7A in that one of the shaped plates, 702a, has been replaced with shaped 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 both the inner surface of the palate and the teeth. In some embodiments, the shaped plates also include sections shaped to conform to the inner surfaces of the teeth proximal to the gum line. Such shaped plates are not specific to the embodiment shown in FIG. 7B and can be present in any conforming embodiment. In the embodiment shown, the shaped plates contact four teeth, but those skilled in the art will understand that embodiments of the present invention need not be limited to contacting four teeth, and other numbers of teeth, such as one, two, three, five, or six, are also contemplated. In the device 760 of Figure 7C, two shaped plates 762a, 762b are provided. The device 760 of Figure 7C differs from the device 700 of Figure 7A in that the expansion mechanism 764 does not include threads. The expansion mechanism includes a pair of elongated alignment rods 766 that extend between two hydraulic force actuating components. In the device 800 of Figure 8A, only a single shaped plate 802b is provided. The other shaped plates are completely replaced by a wire structure 806, with the wire 802a shaped to conform to the inner surfaces of the teeth and not directly contacting the inner surface of the palate. In the embodiment shown, the wire contacts three teeth, but those skilled in the art will understand that embodiments of the invention need not be limited to contacting three teeth, and other numbers of teeth are also envisioned, for example, 1, 2, 4, 5, or 6 teeth.

[0096] FIG. 8B shows an enlarged view of a central mechanism that can be used with the device shown in FIGS. 7A-8A. In this embodiment, the screw provides a static "background" force that can be externally modified by tightening or loosening using a hole in the top surface of the screw head. In use, the hydraulic component provides an additional cyclical force that is substantially superimposed on the static force to generate a non-zero cyclical force. In the illustrated embodiment, one side of the palate represents a first anchor point, and the portion of the mouth where the other component is located represents a second anchor point, and the generated force acts to tension the palate located between those areas. To a certain extent, the dental arch is also forced into a flexed state, thereby acting to widen the palate. Various examples demonstrating the modularity of the present invention are shown in FIG. 8C.

[0097] The embodiment shown in Figures 9 and 10 is somewhat similar to that shown in Figures 7A-8A, but these devices are oriented in an anterior-posterior direction on the palate to create expansion of the premaxilla. In the configurations shown in Figures 9 and 10, the central mechanism is attached to the top of the mouth (shown with the maxilla inverted) via, for example, a bone screw, although other fasteners are equally suitable. This mechanism can be the same or substantially the same as the mechanism shown in Figure 8B, with a background static force generated by the screw and an additional cyclical component applied hydraulically. In both Figures 9 and 10, the portion of the palate to which the bone screw is attached forms, for example, the first anchor point, and the bone screw forms the first anchor. The second anchor is different in Figures 9 and 10, but in both cases, a shaped plate is used. - In Figure 9, the second anchor is in the form of a molded plate, the anterior edge of which is shaped to fit against the posterior side of the anterior teeth. A portion of the molded plate is also shaped to fit against the surface of the palate. This ensures uniform force transmission to the teeth and palate for uniform maxillary expansion. - In Figure 10, the molding plate is not in contact with the teeth, but instead only with the soft tissue of the upper palate (not shown) where the bone screws can be located.

[0098] Those skilled in the art will appreciate that in the embodiment shown in Figures 9 and 10, the lateral extent of the forming plate can vary and the leading edge can contact a number of teeth other than four, for example, 1, 2, 3, 5, or 6 teeth.

[0099] 11-12B show one embodiment of the present invention including a single shaped plate having a central slot that accommodates a central expansion feature, each shaped to fit the palate with the central expansion feature located therebetween. Alternatively, two separate plates can be used to achieve a similar effect. The outer edge of the shaped plate includes a series of recesses, the locations of which correspond to the locations of the user's teeth. The device further includes a series of balloons configured to fit between the recesses and the user's teeth, such that inflation of the balloons applies pressure to the user's teeth.

[0100] 12C and 12D show an embodiment of the present invention including a single molded plate having a central slot that accommodates a central expansion mechanism, each shaped to fit the palate with the central expansion mechanism positioned therebetween. Alternatively, two separate plates can be used to achieve a similar effect. The outer edges of the molded plates include a series of recesses, the locations of which correspond to the locations of the user's teeth. The device further includes grooves or channels housed within the elongated, expandable structure, the outer surface of which contacts the inner surface of the cantilever structure in the form of cantilever fingers.

[0101] The cantilever structure is positioned so that its outer surface is substantially aligned with the tooth-facing surface of the recess in the molding structure. In use, when the expandable structure is expanded and thus expands outward, its outer surface exerts pressure on the inner surface of the cantilever structure, pressing the tooth-facing surface of the cantilever structure against the tooth surface, thereby causing tooth displacement and, if multiple teeth are moved, causing dental arch expansion (i.e., maxillary expansion). In this manner, the expandable structure is configured to move the cantilever structure between an unbiased configuration (i.e., the cantilever is housed within the molding structure) and a biased configuration in which the cantilever structure extends forward from the tooth-facing surface of the recess. In this manner, the cantilever structure defines an intermediate structure disposed between the expandable structure and the tooth.

[0102] In an alternative arrangement, the cantilever structure can be positioned to extend from the tooth-facing surface of the recess even when no force is being applied by the expandable structure. Thus, when the molded plate is placed in a patient's mouth (i.e., the tooth-facing surface of the recess is brought into contact with a tooth), the corresponding tooth exerts a force on the outer surface of the cantilever structure, thereby biasing the cantilever structure toward the expansion structure. The expansion structure can be configured to withstand the resulting force applied to it by the cantilever structure.

[0103] In the embodiment shown in Figures 11-12D, the inflatable structure can include multiple balloons, each in fluid communication with the other (which is advantageous since they can all be inflated from a single source), although other embodiments can alternatively include multiple balloon strips. The balloons can be independently inflatable to provide a greater degree of control. A static (i.e., "background") force can then be applied by adjusting a screw in the central mechanism so that a constant outward force is applied to the inner surface of the tooth via the balloon. In use, the balloons can then be cyclically inflated and deflated to provide a cyclic component that, superimposed on the static component provided by the forming plate, applies a constantly positive, non-zero force to the tooth, resulting in maxillary expansion. Alternatively, a non-zero force can be generated by balloon expansion, with additional pulsation providing the cyclic component. Note that while the balloons are shown on only one side of the device in the embodiment shown in Figures 11-12B, those skilled in the art will appreciate that balloons may be located on both sides. For example, a single molded plate can be provided and secured to the palate on opposite sides of the central mechanism using bone screws or other suitable fasteners, e.g., along the lines of Figures 9 and 10. Alternatively, a molded plate having an expandable structure on one side can be combined with an alternative anchor structure on the opposite side, such as molded directly to a tooth or wire structure, e.g., similar to Figures 7A-8A. 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, where suitable.

[0104] Figures 12E-12G show an embodiment designed to promote remodeling by acting on the occlusal plane, which can be defined as an imaginary plane between the upper and lower dental arches. The device in Figures 12E-12G includes a series of U-shaped balloons connected to hydraulic tubing, which the user bites down on during use. The cyclic expansion and contraction of the balloons then generates a force that is applied to the user's teeth. A feedback system can be used to indicate how much the user should bite. In Figure 12F, an inflatable bite plate is attached to sections shaped to fit the teeth of the lower dental arch. It will be understood that reverse or other arrangements are also possible. In Figure 12G, multiple balloons are provided, each positioned to contact an individual tooth or series / group of teeth and multiple hydraulic tubes, each operably connected to a respective one of the multiple balloons. The balloons are positioned to conveniently exit the device where the tubing is housed and exits the front of the device. According to an exemplary alternative arrangement, the balloon is positioned within a guide element configured to prevent the balloon from expanding or stretching laterally when compressed between the tooth and bite plate. The guide element comprises a trough or channel with rigid lateral sidewalls. The channel has an open bottom, so that, when in use, the balloon can directly contact the occlusal plane of the tooth. In this manner, the rigid walls ensure that the balloon expands substantially vertically, thereby increasing the application of force to the tooth. Again, other arrangements are possible.

[0105] In Figures 12H and 12I, a cantilever finger is placed at the base of a depression along the occlusal plane. The depression is molded into part or all of the crown of the tooth. When an expandable structure beneath the finger expands, the cantilever finger is displaced upward or at an upward angle, i.e., upward but sometimes tilted. This action delivers force to the uppermost channel of the tooth and the alveolar bone.

[0106] 12J and 12K show cross sections of an alternative maxillary expansion device including an expandable structure and a sliding member, the sliding member defining an intermediate structure disposed between the expandable structure and the teeth.

[0107] The slide member is housed within the molded structure of the device in a manner similar to that described above for the cantilever structure. The device includes a groove or channel housed within the elongated, expandable structure, with the outer surface of the expandable structure positioned in contact with the inner surface of the slide member. The elongated slide member is housed within a corresponding channel extending in a direction substantially perpendicular to the longitudinal direction of the elongated, expandable structure. In use, when the expandable structure is expanded and thus expands outward, its outer surface exerts pressure on the inner surface of the slide member, pressing it against the tooth surfaces, thereby causing tooth displacement and, when multiple teeth are moved, causing dental arch expansion (i.e., maxillary expansion). The slide member is shown in an unbiased configuration (i.e., housed within the molded structure) in FIG. 12J and in a biased position in which the slide member protrudes from the tooth-facing wall of the recess in FIG. 12K.

[0108] The slide member includes a locking portion that is wider than the remainder of the slide member. The locking portion is configured to be received within a corresponding portion of the channel and limit movement of the slide member along the channel. A spring is disposed between the locking portion of the slide member and an inner wall of the channel locking portion. The spring is configured to resist protrusion of the slide member from its channel. The locking portion of the slide member can include a substantially square profile when viewed in the longitudinal cross section shown in FIGS. 12J and 12K. Alternatively, the locking portion can include a triangular or truncated profile when viewed in the same longitudinal cross section. Thus, the locking portion can taper as it extends away from the outer circumferential surface of the slide member.

[0109] FIG. 12L shows a cross section of an alternative maxillary expansion device including an expandable structure and a dipper-shaped member. The dipper-shaped member defines an intermediate structure disposed between the expandable structure and the teeth. The dipper-shaped member includes a dipper or hook-shaped portion disposed to wrap around the patient's teeth or, when in use, a dental implant. In use, the dipper-shaped member is actuated in a manner similar to the cantilever member and / or sliding member described above. In particular, expansion of the expandable structure results in the application of force by the dipper-shaped portion to the teeth, causing maxillary expansion. The dipper-shaped portion can be configured to cover different percentages of the labial and lingual surfaces of the teeth. The dipper-shaped portion can be configured to avoid covering or contacting the occlusal surfaces of the teeth.

[0110] In any of the above-described embodiments, the tooth-facing surface of the device can be configured to grip a tooth against which the device is placed. In particular, at least one of the shaped structure, the recess, and the intermediate structure can be configured to have a tooth-gripping portion or portions. The tooth-gripping portion can comprise a rounded or pointed nodule protruding from the tooth-facing surface.

[0111] 13A and 13B illustrate components that can secure a central molding plate to the upper jaw of a user's mouth, for example, using bone screws or other suitable fasteners. In addition to the central molding plate, three additional peripheral molding plates are provided, each shaped to conform to a corresponding surface of the user's mouth, such as a portion of the palate and / or the inner surfaces of the teeth. The three peripheral molding plates are joined to the central molding plate via balloons, an example of which is shown in FIG. 13B. The balloons are positioned between the central and peripheral molding plates so that when the balloons are deflated or only partially inflated by hydraulic fluid, the joints interlock, facilitating access to the anchoring screws. However, when the balloons are inflated, the joints become more rigid, and each peripheral plate is in intimate contact with the portion of the mouth to which it is shaped. The movement of the balloons within the tunnel or between the central and peripheral molding plates exerts a force on the respective contacts.

[0112] In this manner, the balloon can be configured to directly contact the shaped plate structures. Alignment mechanisms can be disposed at the joints between the shaped plate structures. The alignment mechanisms can be configured to maintain alignment of the shaped plates when the shaped plates are separated from one another by expansion of the balloon. The alignment mechanism can include at least one alignment rod disposed to extend across the channel between the shaped plate structures.

[0113] The present invention is not limited to devices for oral use. FIGS. 14A and 14B illustrate an application of a device 1000 according to an embodiment of the present invention used for distraction of cranial sutures. Multiple devices can be placed along one or more sutures. FIGS. 14A and 14B illustrate an exemplary embodiment of a device suitable for this application. FIG. 14A shows the device of FIG. 14B in place on a user's skull. Device 1000 is virtually identical to the device of FIGS. 15A and 15B, and therefore, for the sake of brevity, a detailed description will not be repeated here. The devices of FIGS. 14 and 15 differ from each other only in that in FIGS. 14A and 14B, the screws have flat hexagonal heads, while in FIGS. 15A and 15B, the screws have dome-shaped heads. The operation of these devices is the same. Any of the embodiments using screw fixation can use, for example, dome-shaped formed screws with "slotted" screw holes that allow for easy replacement of the device and do not interfere with permanent fixation, i.e., screws in the given example.

[0114] 15A and 15B show unexploded and exploded examples, respectively, of a component 1500 that can be used as a central magnification mechanism in various embodiments of the present invention. The mechanism 1500 is substantially symmetrical, and therefore, for simplicity, only the right side will be described here. The mechanism 1500 includes the following main components: a central component 1520, a hydraulic component 1540, a channel component 1560, and an attachment component 1580; each of these components will be described in more detail in turn.

[0115] Central component 1520 includes two elongated cylindrical rods 1522a, 1522b, each with a longitudinal axis extending laterally. Located between rods 1522a, 1522b is a central threaded component 1524, which has threaded portions 1525a, 1525b at each end, with the threaded portions facing in opposite directions. The central region of threaded component 1524 is unthreaded. Component 1526 is located at the center of central component 1520. As best seen in FIG. 15A , each of rods 1522a, 1522b has a small, centrally located notch 1528, where central component 1526 is located. The unthreaded proximal portion of threaded component 1524 is integral with component 1526. Located on the top surface of component 1526 is a hollow bore 1530. A pin can be inserted into bore 1530 to rotate threaded component 1524 about its longitudinal axis.

[0116] The hydraulic component 1540 is relatively simple. It includes a balloon portion 1542, which is an elongated, substantially cylindrical balloon 1544 having a conical or frusto-conical tip 1546 at its distal end. The proximal end of the balloon 1544 is connected to a tube 1548, which is connected at its proximal end to a hydraulic pump (not shown). The channel component 1560 is preferably a single piece of material and includes a recess in its outer surface forming a channel 1564, the channel 1560 being shaped to receive the balloon 1544 such that the outer surface of the balloon 1544 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 beyond the outer wall of the component. The channel component 1560 also has two holes 1566, 1568 formed therethrough, with the holes 1566, 1568 each shaped to receive an end of a rod 1522a, 1522b of the central component 1520. Also located between the two holes 1566, 1568 is a recess having a centrally located bore 1572 configured to receive the threaded end of the threaded component 1524.

[0117] The static force is applied by the threaded component 1524 via the internal threads of the central bore of the channel component, which are configured to engage the external threads of the threaded component 1524 .

[0118] The attachment component 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 in the channel component 1560 and are configured to receive the threaded ends of the rods 1522a, 1522b and threaded component 1524 that exit the outer surface of the channel component 1560. Wings 1583, 1585 are integrally formed with the body 1581 of the attachment component 1580, each extending horizontally from the base 1586 of the body 1581 and including holes 1588, 1590 that are configured to receive a respective screw 1592, 1594. Often, one or more fixation pins are preferably permanently secured to the bone of the skull by bone threads. The device attached to the fixation pin has a specially formed locating and locking slot to fit the pin. The fixation pin head is spherical in nature to avoid any sharp edges that could damage soft tissue. A hexagonally shaped hole is located within the top surface of the sphere, allowing the bone thread attached to the spherical head to be turned with a hexagonal tool. The locating slot is formed by two intersecting circles. The larger circle is slightly smaller than the diameter of the spherical head. The smaller circle is slightly larger than the lower shaft of the fixation pin's spherical head. The locating portion of the slot is sized to allow the spherical-head pin to pass over the previously attached bone. The slot is positioned so that the lower shaft of the spherical head matches the smaller diameter of the slot. Additionally, the bottom surface of the spherical head locks into the chamfered edge at the smaller diameter end of the slot. This is all held together by compressive force from a screw or balloon expansion device. See Figures 15C-15E.

[0119] When assembled, rods 1522a, 1522b and the threaded end of threaded component 1524 pass through bores 1566, 1568, 1572, 1582, 1584, 1586. This ensures precise alignment of the components. Attachment component 1580 is secured to the palate using bone screws 1592, 1594. Component 1500 is then adjusted by turning the threads on threaded component 1524 to apply a constant outward force to the palate via screws 1592, 1594. This force forms the background static force referred to elsewhere in this application. In use, balloon 1544 is then cyclically inflated and deflated using a hydraulic pump (not shown). When the balloon 1544 is inflated, it acts to extend beyond the plane that contains the outer surface of the channel component 1560, thus exerting additional force on the inner surface of the attachment component 1580. When this occurs simultaneously on both sides of the mechanism 1500, the area between the two pairs of threads is subjected to a distraction force, which, in one application, promotes maxillary expansion by separating the palatal sutures.

[0120] Figures 16A-16D illustrate examples of inserts that can be worn on teeth in combination with devices according to other embodiments of the present invention to prevent, repair, or augment tooth tilt during reconstruction. The insert includes a molded, retainer-like component with a recess shaped to fit the outer surface of the tooth. Each recess / dimple is shaped so that the inner surface of the device closely contacts the tooth's surface, the uppermost portion, and a portion of the tooth's outer surface, and a structure, in this case a cantilever finger, sits on the corresponding inner surface of the recess. Figures 16C and 16D demonstrate that the presence of a small gap between the outer surface of the tooth and the outer wall of the device allows the tooth to move and tilt, then further rotation is prevented and the tooth begins to upright with the application of additional force. The insert is preferably used in combination with the embodiment shown in Figures 11-12B, for example, so that the balloon expands against the insert rather than directly against the tooth. The structure within the recess is preferably positioned so that the balloon expands against the insert and force is transmitted to the tooth via the finger rather than by the entire inner surface of the recess. By ensuring that the cantilever fingers contact the teeth on the inner surface near the base of the tooth (i.e., "gingival margin"), it is possible to ensure that outward forces applied to the teeth act to widen the dental arch by promoting translation of the teeth. While the embodiment shown in Figures 16A-16D is a maxillary appliance, those skilled in the art will understand that a mandibular appliance is equally viable.

[0121] 17A-17C illustrate various ways in which devices 700, 800, 900 can be attached to a user U. Note that the intraoral components of these devices 700, 800, 900 can be as shown in FIGS. 1-2 for maxillary / mandibular expansion, or alternatively can be used for maxillary or mandibular lengthening (moving forward) as described below.

[0122] The embodiment of FIG. 17A includes a harness 702 having a central chest portion 704 and four straps 706, 708, 710, 712 extending from the central chest portion 704. The underside of the harness (not shown) includes a single back plate integrally formed with a head plate 714. An additional strap 716 is positioned across the user U's forehead to securely fasten the user's head to the head plate 714. The device 700 includes a force generator 718 configured to generate a linear cyclic force within a connector 720. This force may be generated, for example, by a motor or pump. At the upper end of the connector 720, a bent portion B is located, with a portion 722 entering the user U's mouth. Within the user's mouth, the rod may connect to the maxilla or mandible, thereby exerting a force on that bone as a result of the cyclic force, which acts to cause anterior displacement of the maxilla / mandible and thus lengthen the bone. The presence of harness 702 with chest plate 704, back plate, and head plate 714 ensures a consistent distance between bend B and the point in the user's mouth where the distal end of portion 722 contacts the craniofacial feature of interest, thus maximizing the effect of the force on the user's craniofacial structures. Figures 17B and 17C differ from Figure 17A in that connector 820 bifurcates at bend B in Figure 17B and there are two connectors 920a, 920b in Figure 17C, respectively. These arrangements can help ensure optimally symmetrical extension of the desired craniofacial structures.

[0123] FIG. 18 shows an alternative embodiment of the present invention that can be used for maxillary distraction, i.e., to pull the upper jaw forward. The device 1001 includes four main components: a head brace 1002, a pair of motors 1004a, 1004b, a pair of telescoping arms 1006a, 1006b, and a crossbar 1008. The head brace 1002 is shaped to fit snugly against the back of the user's head and extends forward toward the base of the user's lower jaw. The head brace includes a back portion 1010 that contacts the back of the user's head and two side portions 1012a, 1012b that are integrally formed with the back portion 1010 and cover the sides of the user's head. Each of the side portions 1012a, 1012b includes holes 1014 for the user's ears. Located at the top of the head brace 1002 is an adjustment device 1016 including screws 1018a, 1018b for adjusting the lateral tightness of the head brace 1002 to ensure a secure fit on the user's head. Located at the front of each of the side sections 1012a, 1012b is a respective motor 1004a, 1004b. In the embodiment shown in FIG. 18, the motors 1004a, 1004b are stepper motors, although those skilled in the art will appreciate that other types of motors may actually be used. Each motor 1004a, 1004b is connected to the proximal end of a respective telescoping arm 1006a, 1006b, which acts as an actuator for extending and retracting the telescoping arms, respectively. The distal ends of the telescoping arms 1006a, 1006b are connected to the ends 1008a, 1008b of the crossbar 1008.

[0124] FIG. 19 shows the crossbar 1008 in more detail in an exploded view. The crossbar 1008 includes an elongated plate 1020 having ends 1020a, 1020b. A wide portion 1022 is located in the central region of the crossbar, with narrower portions 1024a, 1024b located on either side of the wide portion 1022. Two holes 1026a, 1026b are formed in the wide portion 1022. Zeroing screws 1028a, 1028b pass through each of the holes 1026a, 1026b. On the near side N of the plate 1020, wave springs 1030a, 1030b and extension ferrules 1032a, 1032b are located at the ends of the respective screws 1028a, 1028b. On the far side F of the plate 1020, tension rods or cables 1034a, 1034b are attached to the ends of the screws 1028a, 1028b, at the distal ends of which are bone screws 1036a, 1036b. To fit the device, the crossbar 1008 is placed in a fully retracted position (i.e., the telescoping arms 1006a, 1006b are fully retracted). The tension rods or cables 1034a, 1034b are then attached between the bone screws 1036a, 1036b and the screws 1028a, 1028b; this attachment mechanism can also be easily reversible, for example, hooks or clasps, between the bone screws and the tension rods or cables. The tension ferrules 1032a, 1032b are then turned until a predetermined tension can be felt in the bone screws 1036a, 1036b.

[0125] In operation, the motion of the stepper motors 1004a, 1004b translates into extension / retraction of the telescoping arms 1006a, 1006b, thus moving the crossbar 1008 back and forth in front of the user's face. In particular, when the telescoping arms 1006a, 1006b are extended, the plate 1020 is displaced away from the user's face, causing compression of the wave springs 1030a, 1030b, resulting in displacement of the screws 1028a, 1028b and therefore a change in extension of the bone screws 1036a, 1036b. Thus, by selecting the displacement profile of the crossbar 1008 relative to the headrest 1002 caused by the motion of the motors 1004a, 1004b, it is possible to construct an extension versus time profile for the bone screws 1036a, 1036b. Alternatively or additionally, the telescoping arms 1006a, 1006b (and other components) may be adjusted manually or by actuation components.

[0126] Figures 20A and 20B show an alternative crossbar structure 1108, with like numbers referring to the same features as in Figure 19. The crossbar 1108 of Figures 20A and 20B differs from the crossbar 1008 of Figure 19 by further including strain gauges 1138a, 1138b for measuring strain on the extension rods or cables 1134a, 1134b.

[0127] Figure 21 is similar to the device in Figure 18, except the actuator is a hydraulic pump rather than a stepper motor. This arrangement is shown in more detail in Figures 22A-22C. The hydraulic balloon acts to increase the distance between the lifting plate and the back lifting plate, thus increasing the tension on the tension rod / cable.

[0128] Figure 22A shows an exploded view of the crossbar structure. The operation of the structure is as follows. - The hydraulic actuator is in the fully retracted position and the hydraulic balloon is deflated. - The extension rod / cable is attached between the bone screw and the non-rotating slide. - The zeroing screw is then turned until tension is felt in the bone screw. - At this point the lifting plate will be flush with the front brace. - At this time, the device is in the "rest position". - Coarse vibrations can be achieved by extending and retracting the hydraulic actuator. Pressure changes in the hydraulic actuator provide feedback information about the bone load, which in one example provides the underlying low-frequency vibration force. - Pressure changes in the hydrostatic balloon displace the lifting plate forward, thereby loading the bone. The pressure changes in the hydrostatic balloon also provide feedback information about the loading of the bone. This is used for small, high frequency pulsatile forces.

[0129] Each of the hydraulically actuated head brace arrangements described herein can be configured with at least one severable, 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 reversible connection of a hydraulic pump to one or more hydraulic balloons while preventing hydraulic pressure from being exerted on those balloons.

[0130] 22B and 22C show the lift plate assembly in more detail and can be described as follows. - Universal front and rear clamp slides are connected together via two parallel slide rails that slide freely through two slide rail bushings. - The bushing is fixed to a fixed structure. - The zeroing screw connects to a rod or cable that is connected to the skull. - In the retracted position, the universal front clamp slide (front) contacts the vertical surface of the fixed structure. This is the resting position. - When the hydrostatic balloon is inflated, the general-purpose clamp slide (front) is released from the vertical fixation surface. - This direction is towards the left and the zeroing screw causes tension in the rod or cable connected to the skull. - By varying the volume of hydraulic fluid in the hydraulic balloon, the distance between the universal clamp slide (front) and the fixation structure is varied, thus varying the tension applied to the cable or rod connected to the skull. - To compress the skull via the rod, the universal clamp slide (dorsal) must be pushed to the right. This can be achieved by positioning the hydraulic balloon to the right of the fixation structure, inflating the hydraulic balloon, moving the universal clamp slide (dorsal) away from the fixation structure, and pushing the zeroing screw to the right.

[0131] Figure 23 shows a device similar to that of Figure 18, but with two sets of stepper motors and two crossbars. In this way, extension forces can be applied uniformly across the vertical range of the skull.

[0132] FIG. 24 illustrates an alternative arrangement for securing the rigid arcuate support to the skull using bone screws or other suitable fasteners. A rigid central axle is attached to the center of the rigid arcuate support, and the other end of the axle is attached to a crossbar, such as the crossbars in FIGS. 19-20B. This device operates similarly to the device in FIG. 21, but 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. The compensatory force applied by this device is generated by an actuator, as described above. The actuator may comprise a hydraulic pump or a stepper motor and may be attached to the rigid arcuate support. The actuator may be removably attached to the arcuate support. Additionally, the crossbar may also be removable from the larger structural arrangement.

[0133] Figures 25A-25F are schematic diagrams of one embodiment in which a force is applied to the space between the zygomatic arch and the maxilla. In the embodiment shown, an L-shaped connector is used, and the outer end of the connector (i.e., the end not contacting the skull) can be attached to a device such as those shown in any of Figures 17A-17C, 18, 21, 23, 24, 26, 29A, 30, 31A, 32A, and 34A. In Figures 25A and 25B, the L-shaped connector is configured for maxillary distraction, and in Figure 25C, the L-shaped connector is configured for maxillary expansion. Note that while the connectors in Figures 25D-25F are shown as sharp L-shaped, in preferred embodiments of the invention, the connectors would conform to the contours of the bone surface and allow for occupancy by an expandable structure. Figures 25D-25F illustrate three different ways in which force can be transmitted to the relevant cranial structures. - In Figure 25D, a rigid connector is placed between the zygomatic arch and the maxilla, and the force transmitted from the force generator to the connector is transmitted directly to the zygomatic arch to promote bone growth and / or bone displacement. - In Figure 25E, the balloon is in place between the connector and the zygomatic arch. The connector is fixed in place and can apply a constant force to the bone. Cyclic inflation and deflation of the balloon transfers force to the zygomatic arch. In some embodiments, the balloon can be dynamically inflated / deflated to provide an "active cushion" effect as the connector is actuated. In Fig. 25F, there is no rigid connector, and a regular or shaped balloon fills the space between the maxilla and the zygomatic arch. In such an embodiment, as the balloon is cyclically inflated and deflated, the zygomatic arch is displaced laterally (because it is less resistant to movement than the maxilla). Any adverse compression of the maxilla can be overcome by using the arrangement of Fig. 25D or 25E, for example, in the palate, or by using another intraoral device such as those described elsewhere in this patent application.

[0134] The device 1300 of FIG. 26 is similar to the device shown in FIG. 18 , for example, but is intended for use when the user is lying horizontally rather than sitting or standing. As will be understood, similar reference numerals will be used to denote similar structures hereinafter. The device 1300 includes a head support 1302, motors 1304 a, 1304 b, telescoping arms 1306 a, 1306 b, and a crossbar 1308. The head support 1302 includes a headrest 1310 including a cavity for receiving the head, and side portions 1312 a, 1312 b. In a “lying” device such as that shown in FIG. 26 , the weight of the user’s head acts to prevent the user’s head from moving forward during application of a cyclic force.

[0135] Head brace 1302 optionally further includes additional frame elements 1340 (only one is shown, but one skilled in the art will understand that there may be one on each side, or none at all) integrally formed with side portions 1312a, 1312b. Each frame element 1340 includes a slot 1342 into which a corresponding protrusion on motors 1304a, 1304b fits. Operation of device 1300 is the same as that of the previously described devices, but in a different orientation.

[0136] 27A-27B show an alternative example in which the connectors between the crossbar and actuator can be rotated to connect the extension rods to intranasal structures, for example, as shown. The device shown in FIG. 28 is positioned to reconstruct proximal cranial structures, including the ethmoid bone. In an alternative position, the head brace is configured to provide an attachment point on the zygomatic bone or zygomatic arch. The frame elements and motor are configured to generate an expansion force that is applied to the zygomatic bone in a substantially superior direction. It will be appreciated that while the force exerted by the frame elements is an expansion force, the patient will experience a compression force.

[0137] 29A and 29B show an alternative embodiment of a device capable of applying a wider range of cyclical forces to a user's craniofacial structures. Device 2000 includes a main portion 2002, which includes side portions 2004a, 2004b attached to a base 2006. Each side portion 2004a, 2004b includes a semicircular portion 2008a, 2008b that includes a semicircular recess 2010a, 2010b, which is defined by an inner wall 2012a, 2012b and an outer wall 2014a, 2014b. Inner walls 2012a, 2012b each include a slot 2016a, 2016b, and outer walls 2014a, 2014b each include a slot, e.g., 2018a. The space between the side portions 2004a, 2004b is approximately the width of a human head.

[0138] The device 2000 further includes five arcuate rails 2020, 2022, 2024, 2026, and 2028. Those skilled in the art will appreciate that other embodiments of the invention may exist having fewer (i.e., one, two, three, or four) or more rails. In the embodiment shown, each of the arcuate rails 2020, 2022, 2024, 2026, and 2028 is semicircular, although other arcuate shapes could equally be used. Each end of each arcuate rail 2020, 2022, 2024, 2026, and 2028 is positioned within a respective one of the semicircular recesses 2010a and 2010b and has a protrusion extending through each of the inner slots 2016a and 2016b and outer slots, e.g., 2018a.

[0139] Each of the arcuate rails 2020, 2022, 2024, 2026, 2028 includes a mounting groove or slot 2030, 2032, 2034, 2036, 2038 extending along most or all of its length. Generally, these slots 2030, 2032, 2034, 2036, 2038 are for mounting a component on the arcuate rail, which may be a force generator, a force transmitter (or both), or an anchor.

[0140] In FIG. 29A , it is clear that each of the arcuate rails 2020, 2024, 2026, and 2028 has a different mount. Mounted on rail 2020 is a vibrating plate assembly 2040. The vibrating plate assembly includes a vibrating plate 2042, a force generator 2044, a rod 2046 (which may be telescopic), and a mount 2048. Force generator 2044 is attached to rail 2020 via mount 2048. The output of force generator 2044 is transmitted to rod 2046 and then to vibrating plate 2042. In this case, the vibrating plate is flat, but in some alternative embodiments, the plate can be shaped to accommodate various craniofacial structures. While the embodiment of FIG. 29A shows only a single rail 2020 with a vibrating plate assembly 2040, it should be understood that other embodiments can have additional vibrating plate assemblies. For example, in implementations where an upward force is applied by one or more force transmitters, the plate does not vibrate but can act as an anchor to limit head movement in response to the applied cyclic force, thus maximizing the effect of the force.

[0141] Rails 2024, 2026, and 2028 each have a force transmission component 2050, 2052, and 2054. Structure 2054 on rail 2028 is equivalent to crossbars 1008, 1108, and 1308 described previously in this application. Structure 2054 differs from the equivalent feature on plate 1020 in that it is slightly curved to allow for unresisted sliding along rail 2028. Assembly 2054 is configured to apply a tension force to a given craniofacial structure and includes force generators 2058a, 2058b, force transmitters 2060a, 2060b, and may have tension rods or cables (not shown) connected thereto. Similarly, assembly 2052 is configured to apply a tension force to a given craniofacial structure and includes force generator 2064, and may have tension rods or cables connected thereto.

[0142] Components 2050 and 2052 are compression force transmitters and operate in the same manner as vibrating plate assembly 2040, but have a differently shaped (i.e., smaller) plate 2062.

[0143] In the embodiment shown in FIG. 29A, the component 2050 can rotate relative to the rail 2024 to change the direction in which the compressive force can be applied.

[0144] FIG. 30 shows an embodiment similar to FIG. 29A, with a head cushion mounted on the base.

[0145] 31A and 31B show a device similar to that of FIGS. 29A and 29B, but the rails 2120, 2122 are oriented vertically rather than horizontally, and thus are capable of rotating around the user's head from left to right rather than top to bottom. Components located on the rails are capable of moving up and down along their respective rails. Note also that one of the rails includes a roller. Rollers are not limited to this embodiment and can be a feature in any embodiment of the invention.

[0146] Figures 32A and 32B show a modified version of the device with vertical rails, where the wall has been removed to reduce the restriction of lateral movement. This example demonstrates the framework being used to position two opposing pressure pads. These pressure pads are positioned across the skull. An actuator can apply a variable force to the skull surface. Additionally, the pressure pads can oscillate around their axis to apply a twist to the skull surface. These oscillations can be limited to ±45°, for example to push downward by a quarter turn. These oscillations can be uniform sinusoidal or irregular.

[0147] In one example, one pressure pad can apply an inward rotational force, while the other pad can apply a zero or constant opposing force to limit head movement.

[0148] FIGS. 33A and 33B illustrate a cranial reconstructing helmet 3300 according to one embodiment of the third aspect of the present invention. The inner surface of the helmet 3300 is shaped to fit snugly against the outer surface of a user's head. As seen in FIG. 33B, the inner surface of the helmet 3300 includes a plurality of cylindrical balloons 3302. While FIG. 33B shows the balloons 3302 covering only a portion of the inner surface of the helmet 3300, those skilled in the art will understand that the present invention encompasses embodiments in which any amount of the inner surface of the helmet 3300 is covered by the annular 3302. Those skilled in the art should also note that the balloons need not be annular. In use, the two anchor points can correspond to two opposing points on the user's skull, and the two anchors of the cranial reconstructing device correspond to portions of the inner surface of the helmet 3300 that contact the anchor points. The cyclic inflation and deflation of the balloons 3302 can apply a cyclic force to the skull. In a preferred embodiment, the helmet 3300 is sized to fit snugly against the user's head to provide a "background" compressive force, which is then supplemented by a cyclical force provided by the inflation and deflation of the balloons 3302. The balloons can be individually connected directly to a hydraulic compressor, or can be connected in a daisy chain so that the entire block of balloons is inflated simultaneously. With the hydraulic balloons deflated, the helmet is placed on the head and the balloons are inflated. The balloon pressure can be varied to any desired waveform to create a pulsating massage effect. By properly interconnecting the balloons with multiple pressure lines to the compressor, the balloons can sequentially create a wave-like massage sequence when inflated / deflated. Note that in these and all other embodiments of the present invention, there can be multiple balloons, and the balloons can be of different shapes, sizes, orientations, and positions (including relative proximity to the skull). The balloons can also be different textures. There may be additional elements that can displace an inflated balloon, or equally, an inflated balloon can displace additional elements.

[0149] FIGS. 34A-34C are simplified diagrams of an alternative cranial device. In FIG. 34A, the user places their head on the lower sheet, which includes a recess that allows 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 against the user's face to provide a background force. A cyclic force can then be applied by water pressure, for example, using the annular balloon of FIGS. 33A and 33B. Alternatively, the upper portion can have other components for applying compressive or tensile forces, such as the compressive force transmitter shown in FIG. 29A and FIGS. 31 and 32B. FIGS. 34B and 34C demonstrate other configurations of devices to which a device according to the present invention can be attached.

[0150] 34D and 34E show a similar embodiment having a "butterfly" arrangement, where the two side portions are moved inward together over the user's face.

[0151] The embodiment shown in Figures 34A-34E can be modified to provide tension rather than compression to the cranial structures. For example, attachment portions located on the interior surface of the device can be positioned to connect to bone screws or other devices on the user's skull, thereby applying tension to the device. As with other embodiments, this can then be a background force, on top of which a periodic force can be applied by water pressure.

[0152] Figure 35 shows a horizontal platform configured for accessing the mouth connected by two arms to an actuator, which may be mounted on a back plate or rail, such as in Figures 29, 30, 31, and 32. When the platform is actuated, it exerts a force on an anchor point in the mouth.

[0153] Figures 36A and 36B show structures attached to a horizontal platform, which in these examples are positioned to apply a force to the palate without impacting the teeth. The inflatable structure is positioned between the lateral arms of the appliance and the horizontal platform, as shown in Figure 36A. In an alternative configuration, shown in Figure 36B, the inflatable structure is positioned between the palate and the curved surface of the appliance. In each of the configurations shown in Figures 36A and 36B, the inflatable structure acts to apply a force to the palate. In Figure 36A, the force is applied by actuation of the appliance, while in the configuration shown in Figure 36B, the force is applied directly to the palate. In each of these configurations, the horizontal platform is fixed in place and applies a constant force indirectly (i.e., through the oral appliance) or no force at all. The inflatable cushion can also be used as "active cushioning" when the horizontal platform is actuated. For example, the inflatable structure can be sealed to passively absorb forces applied to 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.

[0154] According to an alternative arrangement to that shown in Figures 36A and 36B, the expandable structures can be positioned between the arms of the appliance and the occlusal planes of the teeth. Thus, activation of these expandable structures would cause direct application of force to the teeth. Such an arrangement of the expandable structures can be provided in addition to either of the arrangements shown in Figures 36A and 36B.

[0155] 38A and 38B illustrate a Matthew-Tessiers distractor that can be used in conjunction with embodiments of the present invention.

[0156] While the present invention has been described in conjunction with the exemplary embodiments set forth above, many equivalent modifications and variations will be apparent to those skilled in the art given this disclosure. Accordingly, the exemplary embodiments of the invention set forth above are considered to be illustrative rather than limiting. Various changes can be made to the described embodiments without departing from the scope of the invention. All references referred to above are incorporated herein by reference.

Claims

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

2. the generated force includes a periodic component; 10. The apparatus of claim 1.

3. the generated force is constant or substantially constant; 3. The device according to claim 1 or 2.

4. the force transmission structure includes an expandable structure; 4. An apparatus according to any one of claims 1 to 3.

5. the force transmission structure includes a first expandable structure rigidly connected to the first anchor and a second expandable structure rigidly connected to the second anchor; 5. The apparatus of claim 4.

6. the first expandable structure and the second expandable structure are connected in series with each other; 6. The apparatus of claim 5.

7. the force transmission structure includes a first channel that contains the expandable structure; 7. Apparatus according to any one of claims 4 to 6.

8. the force transmission structure includes a shaped structure, the shaped structure including a first recess shaped to conform to at least one of an inner surface, an outer surface, and an occlusal surface of a first tooth, the recess including a first intermediate structure, a surface of the first intermediate structure positioned to contact a surface of the first tooth when the appliance is in place in the user's mouth; 8. The apparatus of claim 7.

9. the first channel is located within a portion of the shaping structure behind the first intermediate structure, and the expandable structure is positioned to apply a force to the first intermediate structure when expanded, the force being transmitted through the first intermediate structure to the first tooth; 9. The apparatus of claim 8.

10. the shaped structure includes a plurality of recesses, each recess shaped to fit over the interior surface of a respective tooth, each recess including a respective intermediate structure, the surface of the intermediate structure being positioned to contact the surface of the respective tooth when the appliance is in place in the user's mouth; 10. The apparatus of claim 9.

11. the first channel is arcuate and is located behind each of the respective cantilever structures, such that when the expandable structure is expanded, it exerts a force on each of the intermediate structures, and the force is transmitted through the respective intermediate structure to each of the teeth; 11. The apparatus of claim 10.

12. 12. The device of claim 7, 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.

13. the device is modular; 13. An apparatus according to any one of claims 1 to 12.

14. the force generator is removable; 14. Apparatus according to any one of claims 1 to 13.

15. the force generator is connectable to at least a portion of the force transmission structure by a severable self-sealing connection; 15. Apparatus according to any one of claims 1 to 14.

16. the severable self-sealing connection includes a valve; 16. Apparatus according to any one of claims 1 to 15.

17. the severable self-sealing connection includes at least one of a one-way valve and a reversible valve; 17. Apparatus according to any one of claims 1 to 16.

18. the force transmission structure is configured to transmit a first force to the first anchor and a second force to the second anchor, the first force being in an opposite direction to the second force; 18. Apparatus according to any one of claims 1 to 17.

19. the force transmission structure is configured to apply the generated force directly to only the first anchor, and in use the first force is applied as a reaction force via the cranial structure to the second anchor.

20. The apparatus of claim 18.

20. the force transmission structure is configured to apply the generated force directly to the first anchor and the second anchor.

20. Apparatus according to any one of claims 1 to 19.

21. the device defining an expansion mechanism for effecting maxillary or mandibular expansion; the hydraulic force transmission structure comprises first and second hydraulic components, first and second channel components arranged to house the first and second hydraulic components, respectively, and a central component arranged to connect the first and second channel components; The apparatus of claim 1 , wherein the first anchor point defines an attachment component for the first channel component and the second anchor point defines an attachment component for the second channel component.

22. 22. The device of claim 21, wherein the attachment component comprises wing portions extending from a body of the attachment component, the wing portions comprising holes configured to receive fasteners configured to fasten the attachment means to a user's cranial structure.

23. 23. The apparatus of claim 22, wherein the aperture comprises a locating slot configured to releasably couple the wing portion to the fastener, the locating slot comprising two intersecting circular apertures, a first aperture larger than the diameter of a head portion of the fastener and a second, smaller aperture larger than the diameter of a shaft portion of the fastener and smaller than the diameter of the head portion of the fastener.

24. 1. A cranial remodeling device for expanding, compressing, or bending a cranial 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 periodic force; a first anchor for attachment to the first anchor point; a force transmission structure connected to the force generator and configured to transmit the periodic force to the first anchor in a restructuring direction; The head support The device includes limiting means configured, in use, to prevent or limit movement of the user's head in the reconfiguration direction when the cyclic force is applied.

25. the force transmission structure is a hydraulic force transmission structure; 25. The apparatus of claim 24.

26. 1. A cranial remodeling device for expanding, compressing, or bending a cranial 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; a first anchor for attachment to the first anchor point; a force transmission structure connected to the force generator and configured to transmit the periodic force to the first anchor in a reconfiguration direction, the force transmission structure being a hydraulic force transmission structure; The head support The device includes a limiting means configured, in use, to prevent or limit movement of the user's head in the reconfiguration direction when the cyclic force is applied.

27. the generated force is constant or substantially constant; 27. The apparatus of claim 26.

28. the generated force includes a periodic component; 27. The apparatus of claim 26.

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

30. the head support is configured to be fastened around a user's head, thereby applying a force to the sides, front or back of the user's head and / or face, such that an inner surface of the head support forms at least part of the restraining means and frictionally restricts movement of the user's head; 30. Apparatus according to any one of claims 24 to 29.

31. the limiting means includes an abutment surface configured to abut against the user's head in use, and contact with the abutment surface is configured to prevent or limit movement of the user's head in the reconfiguration direction.

31. Apparatus according to any one of claims 24 to 30.

32. the device includes a cradle having rails; 32. Apparatus according to any one of claims 24 to 31.

33. the rail is connected to the head support by one or more connectors; 33. The apparatus of claim 32.

34. the device includes a first connector and a second connector, the rail attached to an end of the connector distal to the force generator; 34. The apparatus of claim 33.

35. the device further includes a third connector, the third connector connected at a proximal end to the rail and at a distal end to the first anchor.

35. The apparatus of claim 34.

36. the device further comprising a second anchor for connecting to a second anchor point on the cranial structure; 36. Apparatus according to any one of claims 24 to 35.

37. the device further includes a fourth connector, the fourth connector connected at a proximal end to the rail and at a distal end to the first anchor.

37. The apparatus of claim 36.

38. the device includes a plurality of rails; 38. Apparatus according to any one of claims 24 to 37.

39. each rail of the plurality of rails is connected to at least one force generator by at least one connector; 39. The apparatus of claim 38.

40. The limiting means is located on a rail.

40. Apparatus according to any one of claims 24 to 39.

41. the force generator includes one or more of a motor and a hydraulic pump; 41. Apparatus according to any one of claims 24 to 40.

42. The first anchor point is a first tooth, the first anchor includes a component that contacts the first tooth, and the component that contacts the first tooth includes: Wrapped around the first tooth; or configured to abut an inner or outer surface of the first tooth; 42. Apparatus according to any one of claims 1 to 41.

43. the first tooth-contacting component comprises one or more of a wire, a band, a plate, or another orthodontic fixture; 43. The apparatus of claim 42.

44. The second anchor point is a second tooth, the second anchor includes a component that contacts the second tooth, and the component that contacts the second tooth includes: Wrapped around the second tooth, or configured to abut against an inner or outer surface of the second tooth; 44. Apparatus according to claim 42 or 43.

45. the second tooth-contacting component comprises one or more of a wire, a band, a plate, or another orthodontic fixture; 45. The apparatus of claim 44.

46. the first tooth-contacting component or the second tooth-contacting component includes a portion shaped to conform to the respective first tooth or second tooth surface; 46. ​​Apparatus according to any one of claims 42 to 45.

47. one or both of the first anchor and the second anchor include a screw configured to directly contact bone or soft tissue; 47. Apparatus according to any one of claims 1 to 46.

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

49. the force transmission structure is a hydraulic force transmission structure; 49. The apparatus of claim 48.

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

51. the generated force includes a periodic component; 51. The apparatus of claim 50.

52. the generated force is constant or substantially constant; 52. The apparatus of claim 51.

53. the head support includes a helmet, the inner surface of the helmet being shaped or molded to conform to the outer surface of the user's head; 53. Apparatus according to any one of claims 48 to 52.

54. The head support includes a first portion positioned to cover the cranial structure to be compressed and a second portion positioned opposite the cranial structure.

54. Apparatus according to any one of claims 48 to 53.

55. the head support including first and second sections movable relative to one another, and means for connecting the first and second sections such that an inner surface of each of the first and second sections is configured to apply a compressive force to the user's skull; 55. Apparatus according to any one of claims 48 to 54.

56. the force generator is configured to generate a force having a profile including aperiodic regions and periodic regions; 56. Apparatus according to any one of claims 1 to 55.

57. the force generator is configured to receive input from a measurement device and adjust a characteristic of the generated force in response to the input from the measurement device.

57. Apparatus according to any one of claims 1 to 56.

58. the force generator is configured to adjust the force characteristics to maintain a constant rate of remodeling of the cranial structure.

58. Apparatus according to any one of claims 1 to 57.

59. The measuring device includes a pressure gauge, a strain gauge, a device for measuring displacement of a cranial structure, an electrocardiogram machine, an electroencephalogram machine, or an electromyogram machine.

59. Apparatus according to any one of claims 1 to 58.

60. the device includes a first component configured to deliver a static force to the first anchor and / or second anchor, and a second component configured to deliver the cyclic force to the first anchor and / or second anchor; 60. Apparatus according to any one of claims 1 to 59.

61. the first component is adjustable; 61. Apparatus according to any one of claims 1 to 60.

62. the force generator is an external force generator; 62. Apparatus according to any one of claims 1 to 61.

63. the force transmission structure is configured to transmit a force from outside the user's body to a location within the user's body; 63. Apparatus according to any one of claims 1 to 62.

64. the force generator is located within a housing configured to be attached to a harness; 64. Apparatus according to any one of claims 1 to 63.

65. the force transmission structure includes one or more non-expanding, non-compressible wires configured to transmit the force as tension; 65. Apparatus according to any one of claims 1 to 64.

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