Patent Application
20190053968
The present invention relates generally to the stimulation of bone growth, healing of bone tissue, and treatment and prevention of osteopenia, osteoporosis, and chronic back pain, and to preserving or improving bone mineral density, and to inhibiting adipogenesis particularly by the application of repeated mechanical loading to bone tissue.
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each such individual publication or patent application were specifically and individually indicated to be so incorporated by reference.
Low bone mineral density (BMD) and osteoporosis are significant problems facing the elderly, leading to 1.5 million fractures in 2002 (National Osteoporosis Foundation (NOF): America's bone health: The state of osteoporosis and low bone mass in our nation. Washington D.C., National Osteoporosis Foundation, 2002). Bisphosphonates, a class of compounds that generally inhibit the digestion of bone, have been used for over a decade to treat osteoporosis with significant success but cause unwanted side effects including osteonecrosis of the jaw, erosion of the esophagus, and atypical femoral fractures, which has led to the reconsideration of the use of bisphosphonate therapy.
One alternative to treat osteoporosis has been the use of Whole Body Vibration (WBV), which consists of repeated mechanical loading of bone tissue through vibration devices, using relatively high frequencies (e.g. 15-90 Hz) and relatively low mechanical loads (e.g. 0.1-1.5 g's). Studies have shown that WBV can delay and/or halt the progression of osteoporosis (Rubin et. al., Journal of Bone and Mineral Research, 19:343-351, 2004). In another randomized study, in which ≥0.6 g's of vibratory force were delivered to the feet of the patient, it was demonstrated that WBV was effective in improving hip BMD outcomes as compared to control groups that either did not exercise or were part of an exercise program (Verschueren et al., Journal of Bone and Mineral Research, 19:352-359, 2004).
Related studies have demonstrated the ability of WBV to improve hip and preserve spine BMD in populations of healthy cyclists, postmenopausal women and disabled children (Am J Phys Med Rehabil 2010; 89:997-1009, Ann Intern Med 2011; 155:668-679, J Bone and Mineral Research 2011; 26(8):1759-1766).
The mechanism by which WBV influences BMD is an issue of some debate but studies have suggested that the shear stress within bone marrow in trabecular architecture during high frequency vibration could provide the mechanical signal to marrow cells that leads to bone anabolism (Journal of Biomechanics 45(2012):2222-2229). More specifically, shear stress above 0.5 Pa is mechanostimulatory to osteoblasts, osteoclasts and mesenchymal stem cells (Journal of Biomechanics 45(2012):2222-2229).
Many conventional methods of promoting bone tissue growth and bone maintenance by the application of WBV generally tend to apply relatively high frequency (e.g. 15-90 Hz) and relatively low magnitude mechanical loads (e.g. 0.1-1.5 g's) to bodily extremities, such as the use of vibrating platforms upon which a user stands that apply repeated mechanical loads to the feet of a user. Current WBV vibration platforms (e.g. Galileo 900/2000™, Novotec Medical, Pforzheim, Germany; or Power Plate™, Amsterdam, The Netherlands) and associated treatment regimens require the user to stand on a platform for up to 30 minutes a day, which is inconvenient for many users. Furthermore, applying vibration to the feet of the patient is an inefficient method for mechanically loading the hips, femur, and spine, the targeted areas for WBV therapy for osteoporosis. Up to 40% of vibration power is lost between the feet and the hips and spine due to mechanical damping in the knees and ankles (Rubin et al., Spine (Phila Pa. 1976), 28:2621-2627, 2003).
One other issue with current WBV platforms is the directionality of applied force. Standing on a vibrating platform, an individual receives WBV stimulus in a plane perpendicular to the spine and long bones of hip. Studies have shown that vibrations applied “in the inferior-superior direction would be misaligned with the principal trabecular orientation in the greater trochanter and femoral neck, resulting in lower shear. In contrast, trabeculae in the lumbar spine are aligned with the direction of vibration and the permeability is higher” (Journal of Biomechanics 45(2012): 2222-2229).
There is a need for a more efficient and easy to use source of mechanical vibration that delivers around 0.6 g of force directly to the spine and hips. A more efficient method for delivering vibration force would be to reduce the load applied to the patient and make the device easier to use, while maximizing therapeutic benefit to osteoporosis by localizing the repeated mechanical loads delivered to the hip and spine. Additionally, the potential to deliver WBV in a plane perpendicular to the directionality of the spine and long bones of the hip may be more beneficial than a traditional vibrating plate on which a person stands.
Additionally, a portable device, vs. a stationary device may be desired.
Finally, the existing technology of vibrating platforms limits the application of WBV to special populations that may benefit from its use. Cyclists, for example, have been shown to have lower BMD than other athletes and even lower than the BMD of sedentary people (Int J Sports Med 2012; 33:593-599). Thus, a wearable delivery system for this technology extends the reach of this tool to a wider population of individuals. Not only could a wearable device be used during cycling (or other activities), the present invention could be adapted to deliver WBV through a bicycle to the rider for the purpose of preserving BMD in cyclists.
In a separate but connected issue, WBV have been suggested to be “anabolic to the musculoskeletal system” and “in parallel, suppress adiposity” (PNAS. Nov. 6, 2007; 104(45):17879-17884). In animal models, studies have shown that low magnitude WBV can reduce stem cell adipogenesis and can provide a tool for “nonpharmacologic prevention of obesity and its sequelae” (PNAS. Nov. 6, 2007; 104(45):17879-17884). In a study done with obese women, WBV displayed a “positive effect on body weight and waist circumference reduction” (Korena J Fam Med. 2011; 32:399-405).
A wearable vibration device provides a novel method and apparatus for the stimulation of bone growth, healing of bone tissue, and prevention of osteoporosis, osteopenia, and chronic back pain. The wearable vibration device may maintain or promote bone-tissue growth, may prevent the onset of osteoporosis, and may treat chronic back pain.
Generally, one embodiment of the vibration device may comprises a motor configured to be in vibrational conductance with an area of the subject, one or more sensors in communication with the motor for receiving feedback relating to the vibrational conductance from the area of the subject, and a controller in communication with the motor. The controller may be configured to receive the feedback through the one or more sensors and determine an amount of vibrational conductance transmitted to the area of the subject such that the feedback is correlated to a fit of the motor relative to the area of the subject. Additionally, the controller may be further configured to adjust one or more parameters of the motor in response to the correlated fit until the feedback is optimized within a predetermined range for treatment.
In use, one method for positioning the vibration device against the subject, may generally comprise securing a motor to be in vibrational conductance with the area of the subject, actuating the motor to transmit vibrations to the area, sensing feedback via one or more sensors in communication with the motor relating to the vibrational conductance from the area, correlating a fit of the motor relative to the area based on the feedback, and adjusting one or more parameters of the motor in response to the correlated fit until the feedback is optimized within a predetermined range for treatment, if needed.
In some embodiments of the wearable vibration device, the device provides effective treatment by targeted application of oscillating mechanical loads to the hip and spine of a user.
The wearable vibration device allows for delivery of WBV stimulus in side-to-side, front-to-back, and/or in inferior-superior directions. This flexibility in the delivery system allows for better targeting of the hips and spine in the treatment of osteoporosis and loss of BMD. More specifically in one variation, one or more vibrating elements may be positioned against the patient's body via one or more securing mechanisms, respectively, which are configured to position the vibrating elements in a direction lateral to the individual's body such that the mechanical loads are applied laterally to the patient. The fit of the device may be monitored by various sensors and the vibrational energy may be adjusted to compensate for less than optimal fit.
In addition, a wearable device provides the user with more ambulatory options than a stationary device.
It is understood that the term motor, may mean a motor which directly transmits vibrational energy to the subject, or it may be the combination of a motor driving a mechanism which in turn transmits vibrational energy to the subject.
The fit of the wearable vibration device is important to ensure proper function. For example, if the wearable vibration device is too loose or too tight on the body, the proper amount of vibrational energy may not be transferred to the bone(s), or the energy may be transferred to the wrong location, or the energy may be transferred in the wrong direction. In addition, the comfort to the user of the device may be compromised if the fit is not correct.
To ensure proper fit, the wearable vibration device may include one or more than one sensor. These sensors may include, but are not limited to: contact sensor(s), pressure sensor(s), strain gauge(s), accelerometer(s), and gyroscope(s). A sensor or sensors may be placed anywhere on the wearable vibration device, including the straps, bands, securing mechanism, motor, spacer, container etc. In addition, an alarm or alarms may be included in the wearable vibration device to alert the user to adjust the fit. Various types of alarms may be used, including audible, visible, such as a blinking light, tactile, such as a pulsing of the vibrational motor, etc. The alarm may sound for a set period of time, or until the fit is improved, or both. In addition, or alternatively, the securing mechanism of the wearable vibration device may be self-adjusting based on the feedback from the fit sensor(s). This may be achieved with a motor, a thermal mechanism, a mechanical mechanism, an electrical mechanism etc.
Alternatively or additionally, if the fit is not providing the optimal vibrational energy transfer, the processor of the wearable vibration device may adjust the movement of the motor to increase or decrease the vibrational energy being transferred to the user. In this way the optimal treatment vibrational energy may be optimized automatically even if the fit changes during the treatment.
If the motor movement is not in the appropriate range, a motor movement fault is triggered, represented by box 610. The appropriate range may be preset and may depend on the weight, height, age, sex etc. of the user, as well as the treatment type, area, time etc. The appropriate range may also be dynamically set based on the fit of the wearable vibration device and/or other factors. A fault in the motor movement may result in an audible buzzer or alarm, a visible light and/or other alarms.
If the fit is not in the appropriate or optimal range, a fit fault or warning is triggered, represented by box 616. The appropriate range for fit may be based on feedback from any of the sensors described herein. The appropriate/optimal range for fit may be set ahead of time, or may be dynamically set based on the fit of the wearable vibration device and/or other factors. The processor may check for fit on a periodic basis. For example, if the fit check returns two or more consecutive fit faults, the fit warning handler may be triggered. Fit warning handler is represented by box 618. A fault in the fit may result in a pulse alarm, which may be generated by pulsing the vibrational motor, an audible buzzer or alarm, a visible light and/or other alarms.
After hearing, feeling, seeing or otherwise perceiving a fit alarm, the user may either adjust the fit of the wearable vibration device, or the processor may adjust the motor movement as represented in box 614, or both. The frequency, amplitude and other motor parameters may be adjusted to optimize the treatment in response to the fit warning. The motor parameter adjustment may be a continual check occurring in the regular code loop. For example, if the motor frequency changes for whatever reason (fit, movement, activity, body position, time, etc) and is outside of a predetermined window away from a predetermined frequency (30 Hz for example) for a certain timer or counter: then the motor will adjust itself to correct for the error in frequency.
As treatment proceeds, the processor continually or intermittently checks the treatment timer, represented by box 612. If the treatment time is complete, the processor moves onto to box 620 and the treatment is ended. If the treatment time is incomplete, the processor of the wearable vibration device continues the treatment, and continues acquiring motor, fit, and/or other data until the treatment ends.
Outside of the enclosure are other components including power switch 720, charge LED 718, status LED 710 and any fit sensor(s). Fit sensors may include, but are not limited to, contact sensor(s), pressure sensor(s), strain gauge(s), accelerometer(s), and gyroscope(s).
Embodiments to treat other body areas are also envisioned. For example, vibration may be delivered to the foot through a shoe or sock like device, or a device that straps, or otherwise attaches to the foot or lower limb. Vibrational stimulus delivered to the foot or lower limb may help treat osteoporosis or other ailments.
It has also been shown that vibratory noise applied to the sole of the foot may improve sensation, enhance balance, and/or reduce gait variability. The vibratory noise, or energy, may be subsensory or may be sensed by the wearer. As in other embodiments, the application of vibration may be periodic, continuous, or otherwise.
Although embodiments have been described herein, other embodiments are envisioned. For example, the wearable vibration device may be designed to be worn on other areas of the body such as the neck, back, limbs, head etc. The vibrational energy may be configured to be directed in different directions, more than one direction, alternating directions, simultaneously different directions etc. More than one vibrational motor may be present in the device, allowing for more flexibility in directing vibrational energy in terms of direction, body part, etc. the vibrational energy may change with time, increasing/decreasing amplitude, increasing/decreasing frequency, changing direction, cycling through a program, turning on and off, etc. The stimulation vibration may also incorporate different kinds of waveforms. For example, square, triangle, saw tooth, sinusoidal waveforms, etc. These different waveforms may introduce harmonics of the base frequency and may provide enhanced or additional benefits. Multiple frequencies may also be superimposed on each other in the vibrating element. Multiple vibrational motors may be worn on different parts of the body. Multiple wearable vibration devices may be worn. Multiple vibrational motors may be used to partially or fully cancel, augment, or change the vibrational energy applied to the user. Vibrational energy may be transferred transcutaneously to an implanted metal plate. For example, the vibration device may be placed on the outer surface of the leg to vibrate a metal bone plate within the leg to reduce bone necrosis around the plate. This embodiment of the device may be used periodically, possibly once per day or once per week or once per month to reduce necrosis of the bone.
Embodiments of the wearable vibration device may be used for SI joint syndrome, SI joint arthrosis, SI joint instability, SI joint blockage, Myalgia and tendopathia in pelvic region, Pelvic ring instability, In the case of structural disturbance following lumbar spinal fusion, For prophylaxis of relapsing SI joint blockages and myotendopathia (m. rectus abdominis, m. piriformis adduktoren), Symphysis rupture and relaxation, back pain, as well as other conditions.
The vibration device may also be in the form of a back pad, similar to the one shown in
The vibration device may also be in the form of a weighted lap pad, with vibrational plate areas in proximity to the iliac crest areas of the hip bones.
Vibrational treatments may also be performed in forces and frequencies to treat constipation, and other digestion disorders.
Vibrational energy may be at a frequency of about 30-90 cycles per second (Hz). Other frequency ranges are also contemplated such as 1-100 HZ and other sub-ranges therein, such as, 25-35 Hz, including specific frequencies therein, such as about 10 Hz or about 4 Hz. The intensity can range from 0.01 g to 10 g (where 1.0 g=earth's gravitational field=9.8 m/s/s), and other sub-ranges therein, such as 0.01 g to 4.0 g, and specific magnitudes therein, such as about 0.3 g or about 1.0 g.
As shown in
Typically, the input/output devices 910 are coupled to the system through input/output controllers 909. The volatile RAM 905 is typically implemented as dynamic RAM (DRAM) which requires power continuously in order to refresh or maintain the data in the memory. The non-volatile memory 906 is typically a magnetic hard drive, a magnetic optical drive, an optical drive, or a DVD RAM or other type of memory system which maintains data even after power is removed from the system. Typically, the non-volatile memory will also be a random access memory, although this is not required.
While
Some portions of the preceding detailed descriptions have been presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. These algorithmic descriptions and representations are the ways used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. An algorithm is here, and generally, conceived to be a self-consistent sequence of operations leading to a desired result. The operations are those requiring physical manipulations of physical quantities.
It should be borne in mind, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless specifically stated otherwise as apparent from the above discussion, it is appreciated that throughout the description, discussions utilizing terms such as those set forth in the claims below, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.
The techniques shown in the figures can be implemented using code and data stored and executed on one or more electronic devices. Such electronic devices store and communicate (internally and/or with other electronic devices over a network) code and data using computer-readable media, such as non-transitory computer-readable storage media (e.g., magnetic disks; optical disks; random access memory; read only memory; flash memory devices; phase-change memory) and transitory computer-readable transmission media (e.g., electrical, optical, acoustical or other form of propagated signals—such as carrier waves, infrared signals, digital signals).
The processes or methods depicted in the preceding figures may be performed by processing logic that comprises hardware (e.g. circuitry, dedicated logic, etc.), firmware, software (e.g., embodied on a non-transitory computer readable medium), or a combination of both. Although the processes or methods are described above in terms of some sequential operations, it should be appreciated that some of the operations described may be performed in a different order. Moreover, some operations may be performed in parallel rather than sequentially.
This application is a continuation of PCT/US2016/026410 filed Apr. 7, 2016, which is herein incorporated by reference in its entirety for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2016/026410 | Apr 2016 | US |
| Child | 16150031 | US |
