WO2024151481A1 - Devices, systems and methods for enhancement of bone fracture healing and bone strength by vibration treatment - Google Patents

Abstract

A vibrational treatment system for healing broken bones and/or strengthening bones is provided and that, in certain aspects, includes a flexible band or wrap; a case attached to, or integrated with, the flexible band or wrap and defining at least one internal compartment; a housing comprising a vibrating mechanism therein; a controller in operative communication with the electric motor and configured to actuate the vibrating mechanism at a target frequency; and a sensor configured to monitor a parameter of the electric motor during operation, wherein the controller is further configured to compare the monitored parameter with a predetermined threshold magnitude and, if the monitored parameter is determined to drop below the predetermined threshold magnitude, then the controller is configured to communicate with the electric motor to maintain the target frequency.

Description

ATTORNEY DOCKET NO.88676.394078.1.WO.U1 TITLE OF THE INVENTION Devices, Systems and Methods for Enhancement of Bone Fracture Healing and Bone Strength by Vibration Treatment INVENTORS Mark A. Besancon, Victoria, Texas, a citizen of the United States of America. Joseph R. Besancon, Aledo, Texas, a citizen of the United States of America. CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to provisional application number 63/479098, filed January 9, 2023 and titled DEVICES, SYSTEMS AND METHODS FOR ENHANCEMENT OF BONE FRACTURE HEALING AND BONE STRENGTH BY VIBRATION TREATMENT, the entire contents of which is incorporated herein by reference. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0001] None BACKGROUND OF THE INVENTION [0002] FIELD OF THE INVENTION [0003] The invention relates to systems, devices and methods for enhancing healing of fractured bones and strengthening non-fractured bones with vibration treatment. [0004] DESCRIPTION OF THE RELATED ART [0005] Mechanical stimulation is a well-accepted treatment for aiding healing of broken or fractured bones in humans and animals. In addition, vibration treatment may be used to stimulate changes in osteocytes after vibration treatment. Osteocytes are the most abundant cells in bone tissues. Recently, vibration treatment has been studied to examine changes in osteocytes following application of vibration stimuli to the subject bone. See Cheung, et. al., “Enhancement of osteoporotic fracture healing by vibration treatment: the role of osteocytes”, Injury 5252 (2021) S97-S100, incorporated herein by reference in its entirety, hereinafter (“Cheung”). ATTORNEY DOCKET NO.88676.394078.1.WO.U1 Cheung examined morphological and functional changes of osteocytes after vibration treatment in a rat model with bone fracture. The findings indicated that vibration treatment induced significant outgrowth of canaliculi and altered expression of various proteins (E11, FGF23 and scierostin and, particularly, osteocyte specific dentin matrix protein 1 (DMP1). Thus, Cheung demonstrates that vibration treatment significantly increased the mineralization and accelerated osteoporotic growth, and resultant fracture healing in the model. The osteocyte is the major cell type, and as discussed the most abundant cell in bone, to sense mechanical signals and facilitate downstream mineralization and, in the case of fractures, healing of the patient’s bone. [0006] The inducement of increased mineralization and accelerated osteoporotic growth by vibration treatment thus has been demonstrated to aid in healing bone fractures. These benefits are also of use to, e.g., an aging population of humans and/or animals that are subjected to the thinning of bones due to osteoporosis and similar processes. [0007] The most common fracture sites for humans over the age of 50 are the distal radius, humerus, hip and spine fractures. Current clinical procedures simply treat such osteoporotic fractures by fixation followed by weight-bearing ambulation for rehabilitation. Applicant is currently unaware of any clinically useful device, system or method that enhances healing of a bone fracture, or that strengthens bones, e.g., as in aged persons, to help in preventing future fractures. [0008] It would be highly desirable to provide clinically useful devices, systems and/or methods that address, inter alia, these issues. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0009] These drawings are exemplary illustrations of certain embodiments and, as such, are not intended to limit the disclosure. [0010] FIGURE 1A illustrates a perspective view of an aspect of one embodiment of the present disclosure. [0011] FIGURE 1B illustrates a block diagram of an aspect of one embodiment of the present invention. [0012] FIGURE 2 illustrates vibrational vectors generated by one embodiment of the present disclosure. [0013] FIGURE 3 illustrates an end view of one embodiment of the present disclosure. [0014] FIGURE 4 illustrates an end view of one embodiment of the present disclosure. ATTORNEY DOCKET NO.88676.394078.1.WO.U1 [0015] FIGURE 5 illustrates an end view of one embodiment of the present disclosure. [0016] FIGURE 6 illustrates a block diagram of one embodiment of the present disclosure. [0017] FIGURE 7 illustrates a block diagram of one embodiment of the present disclosure. [0018] DETAILED DESCRIPTION OF THE INVENTION [0019] Figure 1 illustrates one embodiment of an exemplary system or device 10 to provide vibration treatment to a bone or bones of a patient wherein the patient may comprise humans or animals. A flexible band 12, comprising e.g., neoprene or similar material, is provided that may comprise mechanisms for connecting a first end 14 and a second end 16 of the flexible band, e.g., Velcro® or the like for cases wherein the flexible band 12 surrounds the subject patient’s limb. For example, a broken humerus may comprise the flexible band 12 being wrapped around the patient’s leg and substantially at the location of the fractured bone. In other embodiments, the flexible band 12 may not wrap around the patient at any point, but may be positionable over the subject bone(s) such that the flexible band 12 does not change position during vibration treatment. [0020] A case 18 may be provided and fixed to, or integrated with, the flexible band 12. The case 18 may be flexible, rigid or configured to expand and contract to hold a vibrating mechanism 20 (see, e.g., Fig. 1B) therein (e.g., in an internal compartment) in a secure manner. In the exemplary embodiment of Fig. 1A, the flexible band 12 and case 18 may comprise neoprene. However, the skilled artisan will readily understand that other materials may also be used, e.g., other flexible or non-flexible materials that transmit vibrational energy, each of which is within the scope of the present disclosure. [0021] In some embodiments, the band 12 may be non-flexible, while in other embodiments the band 12 may be omitted and the case 18 with vibrating mechanism 20 disposed and/or secured therein may be held in place by other means. [0022] The vibrating mechanism 20 of Fig. 1B comprises a housing 22 that may be of a plastic, or other material, and that surrounds an electric motor 24 that may be driven by AC or DC power. As shown in Fig. 1B, a battery 26 is provided and in electrical communication with the motor 24 to drive the motor 24 when actuated. In other embodiments, the battery 26 may be replaced by a connection to AC mains for powering the motor 24. In other embodiments, the battery 26 may be present as well as a connection to AC mains. [0023] The exemplary vibration motor 24 of Fig. 1B comprises an offset weight 28. Generally, ATTORNEY DOCKET NO.88676.394078.1.WO.U1 the vibration motor 24 of Fig. 1B comprises a shaft 30 that rotates along an axis A when rotatingly driven by the motor 24 and wherein the shaft 30 comprises an offset (non-symmetric or eccentric) mass 28 attached to the shaft 30 along a portion of the length of the shaft 30. As illustrated, the offset mass 28 is spaced away from the motor 24 and located at a distal end of shaft 30. The eccentric or offset mass 28 comprises a center of mass C that is spaced radially away from the nominal axis A of the shaft 30, creating an eccentricity when rotated around axis A. The offset or eccentric mass 28 may be attached at any point along the shaft 30, but preferably is at or near a distal end of the shaft 30. As the exemplary vibration motor 24 rotates, centripetal forces are unbalanced and a small, rapid displacement of the motor 24 and housing 22 results. The repeated displacement produces vibrational energy that may be transmitted from the mass 28 and/or motor 24 to the housing 22, through the band 12 surrounding at least a portion of the case 18, and through a patient’s soft tissue to reach a bone therein. [0024] As the skilled artisan will recognize, eccentricity may be achieved by a geometric asymmetry whereby more material is provided on one side of the mass 28 than other portions of the mass 28 in order to move the center of mass C to a position that is spaced apart from the axis A of the shaft 30. In addition, eccentricity may be achieved using a symmetric mass, wherein a portion of the mass 28 is of higher density than the other material’s density in order to move the center of mass C to a position that is spaced apart from the axis A of the shaft 30. [0025] The exemplary vibrating mechanism of Fig. 1B induces the eccentric or offset mass 28 to rotate around the axis A of the shaft 30, following an essentially circular or orbital path. As a result, the motor 24, and the case 18 will vibrate in two directions or vectors, along the X-axis and along the Z-axis. There is no movement or vibration along the direction of the axis of the shaft (Y-axis) as illustrated in Fig. 2, wherein the two vibrational vectors are shown as double- sided arrows. It will be optimal to arrange the vibrational device or system of Fig. 1B such that one or more of the vibrational vectors are directed at the targeted area within the patient’s anatomy, i.e., the region of bone of interest. [0026] The vibrating mechanism 20 comprising an eccentric or offset mass 28 along a motor- driven shaft 30 is merely exemplary. The skilled artisan will understand that alternative vibratory mechanisms 20 may be used to achieve the targeted vibrational effects. [0027] For example, linear resonant actuators will be known to the artisan. The linear resonant actuator may use a magnet, spring and voice coil to cause the desired motor displacement and ATTORNEY DOCKET NO.88676.394078.1.WO.U1 vibration. In this embodiment, the magnet is excited by an electromagnetic field induced in the voice coil and the spring enables the magnet (which has a mass) to oscillate back and forth relative to its normal, non-actuated, resting position. The vibrational energy in this embodiment of a vibrating mechanism is directed along one direction or vector because the magnet only moves in one plane. Accordingly, linear resonant actuators only generate vibrational energy along one vector or in one direction or plane. [0028] Other vibrating mechanisms will readily present themselves to the skilled artisan, all of which are within the scope of the present disclosure. [0029] Turning back to Figs. 1A and 1B, the exemplary vibrating mechanism 20 is secured within the case 18 in preparation for use. [0030] Figure 3 provides one embodiment of the device or system of Fig. 1A and 1B, wherein a vibrating mechanism 20 is disposed and/or secured within the case 18 and the flexible band or strap 12 is wrapped around soft tissue T surrounding a bone B in need of treatment. As shown, the case 18 with vibrating mechanism 20 disposed and/or secured therein is placed over the treatment or target region and the flexible band or strap 12 wrapped around the soft tissue, over the case or housing and secured, e.g., by Velcro®, such that the vibrating case 18 does not move away from the treatment or target region during vibration treatment. As described above, optimally, the vibrational energy generated during the treatment should be directed along at least one vector or path generally toward the bone region of interest B, wherein the direction of the at least one vector comprises the x-axis and/or the z-axis, but not the y-axis. [0031] Figure 4 is an alternate embodiment of a device 30 that comprises two spaced-apart cases 18, each comprising a vibrating mechanism 20 disposed and/or secured therein. A band 12 is shown securing the vibrating mechanisms 20 proximate soft tissue T as above and surrounding the treatment or target bone region B. This embodiment provides vibrational energy directed to the bone region of interest from two spaced-apart locations, thus providing additional vibrational energy and covering more of the area of interest than a device or system having a single vibrating mechanism 20. As discussed above, each vibrating mechanism 20 generates vibrations along at least one vibrational vector comprising the x-axis and z-axis, but not the y-axis. [0032] Accordingly, the vibrations generated from a first one of the two spaced-apart vibrating mechanisms 20 will impact the target or bone region of interest B from different directions and at different angles than a second one of the two spaced-apart vibrating mechanisms 20. ATTORNEY DOCKET NO.88676.394078.1.WO.U1 [0033] Similarly, Figure 5 provides an alternate embodiment comprising a device 40 with three spaced-apart cases 18, each comprising a vibrating mechanism 20 disposed and/or secured therein. A band 12 is shown securing the vibrating mechanisms proximate soft tissue T as above and surrounding the treatment or target bone region B. This embodiment provides vibrational energy directed to the bone region of interest B from three spaced-apart locations, thus providing additional vibrational energy and covering more of the area of interest than a device or system having one or two vibrating mechanisms 20. As discussed above, each vibrating mechanism 20 generates vibrations along at least one vibrational vector comprising the x-axis and z-axis, but not the y-axis. [0034] Accordingly, the vibrations generated from a first one of the three spaced-apart vibrating mechanisms 20 will impact the target or bone region of interest B from different directions and at different angles than a second one or a third one of the three spaced-apart vibrating mechanisms 20. [0035] In other embodiments, more than three-spaced-apart vibrating mechanisms 20 may be provided to provide additional coverage and impact angles. [0036] In some embodiments, the vibrating mechanism(s) 20 may operate in a synchronized or offset frequency and/or vibration magnitude pattern as desirable to enhance bone stimulation and/or healing. In some of these embodiments, as shown in Figure 6, a controller 50 in operative communication with the motor 24 of the vibrating mechanism 20 and comprising a processor P and a memory M may be provided with programmed instructions stored within the memory M and executable by the processor P, wherein the programmed instructions comprise actuation and/or magnitude of vibration patterns and/or sequences. As shown, one, two or three vibrating mechanisms 20 may be controlled with controller 50. [0037] For example and without limitation: [0038] the programmed instructions may comprise vibration magnitude pattern sequences with varying magnitude; [0039] the programmed instructions may comprise instructions for vibration pattern sequences with non-varying magnitude; [0040] the programmed instructions may comprise instructions for synchronized vibration to one vibrating mechanism 20, or two or more vibrating mechanisms 20; and/or [0041] the programmed instructions may comprise instructions for non-synchronized vibration ATTORNEY DOCKET NO.88676.394078.1.WO.U1 to one vibrating mechanism 20, or two or more vibrating mechanisms 20. [0042] The embodiments discussed herein may also be used for smaller or larger bones. [0043] The artisan will understand that one or more such devices or systems may be employed around a region of bone. [0044] As discussed above, the flexible band or strap 12 need not wrap around the soft tissue T surrounding the bone region of interest B. Instead, e.g., in a vertebral fracture, the flexible band 12 or strap with one or more cases 18, each comprising a vibrating mechanism 20 therein, may be laid along the skin of the patient’s spinal region of interest and the vibrating treatment may be executed and wherein the flexible band or strap 12 is configured to remain in position along the patient’s skin. [0045] Generally, the vibrational frequency generated by the vibrating mechanism(s) 20 is within the range of between 20 and 90 Hz, known in the art as low-magnitude high-frequency vibration. A more preferred frequency range may be between 20 and 50 Hz. A most preferred frequency may be targeted to 35 Hz to induce the desired mineralization and osteoporotic stimulation of bone. [0046] Returning to Figure 1, the battery 26 may comprise an exemplary 9V battery, though other voltages may be provided. As the devices or systems described herein are used, the motor 24 of the vibrating mechanism 20 will eventually drain the battery 26 and it will begin putting out less than the exemplary 9V. Generally, motors that are powered by a battery will begin to turn slower as the battery’s output, or potential, decreases. As discussed herein, a target frequency of vibration may be implemented, e.g., 35 Hz. It is important to maintain the target frequency even during the draining of the battery to maximize efficacy of the treatment session. [0047] Thus, certain embodiments the controller 50 illustrated in Figure 6 may comprise the controller 40 being configured to maintain the targeted vibrational frequency, even as the battery begins to drain. In this embodiment, the vibration mechanism 20 continues to vibrate at the targeted, e.g., 35 Hz, frequency as the battery’s output drops below 9V. [0048] As illustrated in Figure 7, in some embodiments, the controller 50 may comprise a voltage sensor V that is in operative communication with the battery 26 and monitors the voltage output of the battery 26. If the sensed voltage is below a predetermined threshold, e.g,. 9V, then the controller 50 is configured to apply an appropriate Pulse Width Modulation (PWM) to the motor 24 to maintain the targeted frequency of vibration as the battery’s output decreases. In ATTORNEY DOCKET NO.88676.394078.1.WO.U1 addition to maintaining the desired vibrational frequency during a treatment session, these embodiments also extend the useful life of the battery 26 as its potential begins to decay. [0049] Continuing with Figure 7, in other embodiments, the controller 50 may comprise an RPM (rotations per minute) sensor R in operative communication with the motor 24 and that senses the number of revolutions the motor 24 makes. If the sensed RPM’s is below a targeted frequency, e.g., 35 Hz, then the controller 50 is configured to apply an appropriate Pulse Width Modulation (PWM) to the motor 24 to maintain the targeted frequency of vibration as the battery’s output decreases. [0050] In some embodiments, the controller 50 may comprise a timer or counter that comprises or can be programmed with a maximum run time for one continuous vibration treatment. The maximum run time may comprise 20 minutes, or greater or less than 20 minutes as will be appreciated by those skilled in the art, for example, depending on the desired treatment area, intensity, and overall medical plan. When the maximum run time is reached, the controller 50 is configured to automatically terminate the vibration treatment. [0051] In other embodiments, the power may be provided by an external power source such as an A/C power source. [0052] The magnitude of the vibrational energy generated by a vibrating mechanism 20 may comprise generation of a waveform, e.g., and without limitation, a sinusoidal waveform, that may comprise an acceleration of less than that of gravitational acceleration. That is, less than “1g” or less than 9.81 m/s². Other accelerations may also be provided and are within the scope of the present disclosure. [0053] As described herein, the embodiments of the vibrational bone healing and/or strengthening device or system may be used to enhance, or speed, the healing of fractured bones. In addition, non-fractured bones, such as those weakened by, e.g., osteoporosis during the normal aging cycle, may be strengthened using the inventions described herein. Various embodiments may be used for human and/or animal applications. Various embodiments may also be used for target regions of any bone of a human or animal. [0054] The description of the present disclosure as set forth herein is illustrative and is not intended to limit the scope of the concepts disclosed herein. Features of various embodiments may be combined with other embodiments within the contemplation of this invention. Variations and modifications of the embodiments disclosed herein are possible, and practical ATTORNEY DOCKET NO.88676.394078.1.WO.U1 alternatives to and equivalents of the various elements of the embodiments would be understood to those of ordinary skill in the art upon study of this patent document. These and other variations and modifications of the embodiments disclosed herein may be made without departing from the scope and spirit of the present disclosure.

Claims

ATTORNEY DOCKET NO.88676.394078.1.WO.U1 Having described the invention, we claim: 1. A vibrational treatment system for healing broken bones and/or strengthening bones, comprising: a flexible band or wrap; a case attached to, or integrated with, the flexible band or wrap and defining at least one internal compartment; a housing comprising a vibrating mechanism therein, the vibrating mechanism comprising an electric motor and a battery connected with the electric motor, and configured to be secured within the internal compartment; a controller in operative communication with the electric motor and comprising: a processor configured to execute programmed instructions and in operative communication with a memory, the processor further configured to actuate the vibrating mechanism at a target frequency, a sensor configured to monitor a parameter of the electric motor during operation, the sensor being in operative communication with the electric motor and the processor, wherein the processor is further configured to compare the monitored parameter with a predetermined threshold magnitude and, if the monitored parameter is determined to drop below the predetermined threshold magnitude, then the controller is configured to communicate with the electric motor to maintain the target frequency. 2. The vibrational treatment system of claim 1, wherein the sensor comprises one or both of a voltage sensor and a rotations per minute (RPM) sensor. 3. The vibrational treatment system of one or both of claims 1 and 2, wherein the monitored parameter comprises voltage generated by the electric motor and/or rotations per minute (RPM) produced by the electric motor during operation. 4. The vibrational treatment system of one or more of claims 1-3, wherein the controller is configured to communicate an appropriate pulse width modulation to the electric motor ATTORNEY DOCKET NO.88676.394078.1.WO.U1 to maintain the target frequency. 5. The vibrational treatment system of one or more of claims 1-4, wherein the controller further comprises a predetermined maximum run time for the electric motor. 6. The vibrational treatment system of one or more of claims 1-5, wherein the vibrating mechanism and controller are configured to generate a waveform that comprises an acceleration of less than that of gravitational acceleration. 7. A vibrational treatment system for healing broken bones and/or strengthening bones, comprising: a flexible band or wrap; a case attached to, or integrated with, the flexible band or wrap and defining at least one internal compartment; a housing comprising a vibrating mechanism therein and configured to be secured within the internal compartment, wherein the flexible band or wrap is configured to wrap around soft tissue of a patient which surrounds a bone region of interest, around the exterior surface of the case that is attached to or integrated with the flexible band or wrap, and secured to a portion of the flexible band or wrap. 8. The vibrational treatment system of claim 7, wherein the vibrating mechanism comprises a motor. 9. The vibrational treatment system of claim 8, wherein the vibrating mechanism is configured to generate vibrational energy in one direction. 10. The vibrational treatment system of claim 8, wherein the vibrating mechanism is configured to generate vibrational energy in more than one direction. ATTORNEY DOCKET NO.88676.394078.1.WO.U1 11. The vibrational treatment system of claim 10, wherein the vibrating mechanism is configured to generate vibrational energy in two directions. 12. The vibrational treatment system of claim 8, wherein the vibrating mechanism comprises a rotatable shaft comprising a rotational axis, the rotatable shaft in rotational connection with the motor and comprising an eccentric mass comprising a center of mass that is spaced radially away from the rotational axis of the rotatable shaft, the eccentric mass located along the rotatable shaft. 13. The vibrational treatment system of claim 12, wherein the eccentric mass is located at a distal end of the rotatable shaft. 14. The vibrational treatment system of claim 12, wherein the eccentric mass comprises an asymmetric shape. 15. The vibrational treatment system of claim 8, wherein the vibrating mechanism comprises a linear resonant actuator. 16. The vibrational treatment system of claim 12, wherein the eccentric mass comprises a symmetric shape. 17. The vibrational treatment system of claim 7, further comprising two or more cases attached to, or integrated with, the flexible band or wrap. 18. The vibrational treatment system of claim 17, further comprising two or more housings, each housing comprising a vibrating mechanism and configured to be secured within one of the two or more cases. 19. The vibrational treatment system of one or more of claims 7-18, wherein the vibrating mechanism is configured to direct vibrational energy in the direction of the bone region of interest. ATTORNEY DOCKET NO.88676.394078.1.WO.U1 20. The vibrational treatment system of one or more of claims 7-19, wherein the vibrating mechanism is configured to vibrate at a frequency range of between 20 and 90 Hz. 21. The vibrational treatment system one or more of claims 7-19, wherein the vibrating mechanism is configured to vibrate at a frequency range of between 20 and 50 Hz. 22. The vibrational treatment system of one or more of claims 7-19, wherein the vibrating mechanism is configured to vibrate at a frequency of 35 Hz. 23. The vibrational treatment system of any one of claims 7-22, wherein the vibrating mechanism is configured to generate vibrations induced by waveforms that comprise an acceleration of less than 9.81 m/s². 24. The vibrational treatment system of one or more of claims 7-22, further comprising a controller in operative communication with the motor and comprising: a processor; a memory in operative communication with the processor; and programmed instructions stored within the memory, wherein the processor is configured to execute the programmed instructions, and wherein the programmed instructions comprise actuation and/or vibration magnitude pattern sequences. 25. The vibration treatment system of claim 24, wherein the programmed instructions comprise vibration magnitude pattern sequences with varying magnitude. 26. The vibration treatment system of claim 24, wherein the programmed instructions comprise instructions for vibration pattern sequences with non-varying magnitude. 27. The vibration treatment system of claim 24, wherein the programmed instructions comprise instructions for synchronized vibration to the two or more vibrating ATTORNEY DOCKET NO.88676.394078.1.WO.U1 mechanisms. 28. The vibration treatment system of claim 24, wherein the programmed instructions comprise instructions for maintaining a target frequency of vibration. 29. The vibration treatment system of claim 24, wherein the programmed instructions comprise instructions for non-synchronized vibration to the two or more vibrating mechanisms. 30. The vibration treatment system of any one of claims 24-29, wherein the controller comprises a voltage sensor in operative communication with a battery and configured to sense voltage output from the battery during use of the system. 31. The vibration treatment system of claim 24, wherein the controller is further configured to adjust a rotational speed of the motor to maintain a targeted rotational frequency if the sensed voltage is below a predetermined voltage target. 32. The vibration treatment system of any one of claims 24-29, wherein the controller comprises a sensor that measures a rotational speed of the motor during use of the system. 33. The vibration treatment system of claim 32, wherein the controller is further configured to adjust the rotational speed of the motor to maintain a targeted rotational frequency if the sensed rotational speed is below a predetermined target. 34. A method for enhancing healing of broken bones, comprising: providing a vibrational treatment system according to one or more of claims 1-33; locating the vibrating mechanism(s) over the bone region of interest; and actuating the vibrating mechanism for a predetermined period of time. 35. A method for increasing strength of bones, comprising: ATTORNEY DOCKET NO.88676.394078.1.WO.U1 providing a vibrational treatment system according to one or more of claims 1-33; locating the vibrating mechanism(s) over the bone region of interest; and actuating the vibrating mechanism for a predetermined period of time. 36. A method for increasing mineralization of bones, comprising: providing a vibrational treatment system according to one or more of claims 1-33; locating the vibrating mechanism(s) over the bone region of interest; and actuating the vibrating mechanism for a predetermined period of time. 37. A method for stimulating expression of osteocyte specific dentin matrix protein 1 (DMP1), comprising: providing a vibrational treatment system according to one or more of claims 1-33; locating the vibrating mechanism(s) over the bone region of interest; and actuating the vibrating mechanism for a predetermined period of time.