Apparatus for treatment or prevention of osteopenia and osteoporosis, stimulating bone growth, preserving or improving bone mineral density, and inhibiting adipogenesis

Abstract

To provide an apparatus for the treatment or prevention of osteopenia and osteoporosis, stimulating bone growth, preserving or improving bone density, and inhibiting adipogenesis.SOLUTION: A vibration apparatus for treating a subject comprises an actuator configured to generate vibrational energy, a securing mechanism for positioning the actuator upon the body of the subject while maintaining portability of the actuator such that the vibrational energy is directed into an area of the body to be treated, an accelerometer disposed along the securing mechanism, and a controller in communication with the actuator and the accelerometer. The controller is programmed to measure an exposure level of the vibrational energy to the area of the body using acceleration acquired from the accelerometer, and to compare the exposure level with a maximum exposure level such that the exposure level is limited by the maximum exposure level within a predetermined period of time.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates generally to the promotion of bone growth, healing of bone tissue, treatment and prevention of osteopenia, osteoporosis, cartilage and chronic back pain, maintenance or improvement of bone density, and inhibition of adipogenesis, particularly following repeated mechanical loading of bone tissue. (Incorporated by reference)

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. [Background technology]

[0003] Osteopenia is a highly prevalent skeletal disorder characterized by accelerated bone loss, which, if untreated, can lead to osteoporosis. Osteopenia, characterized by subnormal bone mineral density (BMD), is defined as a BMD T-score between -1.0 and -2.49 and is estimated to affect 43 million Americans. If BMD loss is unchecked, patients develop osteoporosis (defined as a BMD T-score of 2.5 or less) and are at risk for the serious clinical consequences of fractures. Approximately 50% of women and 25% of men over the age of 50 will experience an osteoporotic fracture, resulting in medical costs of $19 billion annually. Additionally, women with osteoporosis are at highest risk for fracture, but due to the high prevalence of osteopenia, more fractures occur in women with osteopenia. Hip and spine fractures are the most common osteoporosis-related fractures, with over 300,000 hip fractures and over 700,000 spine fractures occurring annually in the United States. Fractures of the proximal femur, in particular, can be disabling and significantly impact an individual's ability to lead an independent life. Furthermore, the mortality rate associated with osteoporotic fractures is 15-30%. Mitigating ongoing bone loss in the early stages of bone loss is paramount to preventing the onset and devastating sequelae associated with osteoporosis.

[0004] Despite the high prevalence of osteopenia, few treatments exist. Current clinical practice guidelines for patients with osteopenia include both dietary modifications (e.g., increased calcium and vitamin D intake) and discussion of the importance of high-intensity exercise. Recent evidence indicates that calcium and vitamin D alone do not reduce fracture risk. While a combination of diet / supplements and exercise is effective in maintaining bone mass, adherence to daily weight-bearing exercise, which effectively stimulates bone cells and mitigates bone loss, is low among older adults. In addition to adherence issues, vigorous aerobic and strength training may increase the risk of injury in susceptible individuals. Alternatively, medications are used to treat bone loss associated with osteoporosis. Bisphosphonates and RANK-L inhibitors, which inhibit osteoclastic bone resorption and osteoclast maturation, are widely prescribed and effective in preventing bone loss. However, there are concerns that long-term use of these medications increases the risk of serious adverse events, such as osteonecrosis of the jaw and atypical subtrochanteric and diaphyseal femoral fractures. Therefore, these medications are generally not prescribed until bone mass is at or near osteoporosis, and the level of benefit in preventing fractures is considered to significantly outweigh the potential harm. Additionally, these serious side effects, as well as less serious but inconvenient side effects (e.g., abdominal pain, nausea, etc.), cause 22 to 82% of patients to discontinue medication within 12 months of treatment. Therefore, there is a need for a safe, effective, and convenient osteopenia treatment that can prevent the early progression of bone loss before patients reach osteoporosis.

[0005] Dynamic mechanical loading of the skeleton is an important factor in regulating bone mass in the body. Bone cells, both osteoblasts and osteoclasts, have been shown to respond to various forms of mechanical loading. Mechanical vibration has been shown to have a stimulatory effect at the bone tissue level in both animal and clinical studies. Animal studies using rat, turkey, and sheep models have shown that vibrations of 30 to 90 Hz (hertz) potently stimulate bone formation in the long bones of the appendicular skeleton. Clinically, a whole-body vibration (WBV) platform has been developed in which a human stands on a vibrating platform and vibrates the body.

[0006] Although WBV platforms have shown promising results, these devices have two important drawbacks. First, current WBV platforms require users to stand on the platform for at least 20 minutes per day, at least three days per week. This therapy can be a significant obstacle to treatment compliance and, therefore, treatment effectiveness. Therefore, a more convenient vibration therapy could improve treatment outcomes. Summary of the Invention [Problem to be solved by the invention]

[0007] A second drawback of current WBV platforms is the trade-off between safe and effective vibration levels. WBV platforms rely on vibration transmitted from the feet to the lower back and spine. It is known that vibration amplitude attenuates as it travels through the skeleton. Therefore, vibration levels on the platform must be higher than therapeutic levels for the lower back and spine. However, regular exposure to higher WBV levels raises safety concerns. The relationship between vibration amplitude, exposure duration / frequency, and safety has been hypothesized but is not fully understood or generally proven, especially for exposures of less than 4 hours per day. ISO 2631-1 (International Standard for Mechanical Vibration and Shock—Evaluation of Vibration Exposure to the Whole Human Body) focuses on providing guidelines for safe levels of vibration transmitted to the body through a supporting structure while a person (e.g., heavy equipment operator, factory worker) is standing or sitting for 4 to 8 hours per day. However, ISO 2631-1 also includes guidelines for extrapolating to shorter exposure periods. Given these considerations, high vibration levels, while effective, may not be safe in the long term. Therefore, a more direct means of delivering vibration to the lower back and spine, while also reducing the overall vibration magnitude experienced by humans, could provide a safe and effective therapy for treating low bone mass.

[0008] In addition, it is preferable that the device is portable rather than stationary. [Means for solving the problem]

[0009] The wearable vibration device provides a novel method and device for stimulating bone growth, healing bone tissue, and preventing osteoporosis, osteopenia, and chronic back pain. The wearable vibration device can maintain or promote bone tissue growth, prevent the onset of osteoporosis and cartilage loss, and treat chronic back pain.

[0010] In some embodiments of the wearable vibration device, the device can provide effective treatment by applying oscillating mechanical loads to the user's hips and spine at targeted locations. In some embodiments, the device is worn over the sacrum, focusing the vibrations on the sacrum.

[0011] The wearable vibration device can deliver WBV stimulation in at least one of the following directions: side-to-side, front-to-back, and up-to-down directions. This flexible delivery system allows for more effective targeting of the lumbar region and spine in the treatment of osteoporosis and bone mineral density (BMD) loss. More specifically, in one embodiment, one or more vibration elements may be positioned relative to a patient's body via one or more corresponding fixation mechanisms configured to position the vibration elements transversely relative to the human body so that mechanical loads are applied transversely relative to the patient. The fit of the device may be monitored by various sensors, and vibration energy may be adjusted to compensate for suboptimal fit.

[0012] Additionally, wearable devices offer users more mobility options than stationary devices.

[0013] A vibration device according to one embodiment for treating a subject generally comprises an actuator configured to generate vibrational energy, a fixation mechanism for positioning the actuator on the subject's body while maintaining portability so that the vibrational energy generated by the actuator is directed toward the part of the subject's body to be treated, and a control unit in communication with the actuator, the control unit being programmed to measure the exposure level of the vibrational energy to the part of the body and compare the exposure level with a maximum exposure level so that the exposure level is limited by the maximum exposure level within a predetermined period of time.

[0014] Another example vibration device generally includes an actuator configured to generate vibrational energy and a fixation mechanism for positioning the actuator on a subject's body while maintaining portability so that the vibrational energy generated by the actuator is directed toward a region of the subject's body to be treated. A first accelerometer is positioned proximate to the region of the subject's body and configured to detect the resulting vibrational energy transmitted to the region of the subject's body. Additionally, a controller may be in communication with the actuator and the first accelerometer, and the controller is programmed to receive a signal indicative of the resulting vibrational energy from the first accelerometer and automatically calibrate the actuator to adjust the resulting vibrational energy until the resulting vibrational energy is within a predetermined range.

[0015] A method of treating a subject according to one embodiment may generally include the steps of generating vibrational energy from an actuator such that the vibrational energy is directed to a body part of the subject while maintaining portability of the actuator; monitoring the vibrational energy delivered to the body part with a control unit; measuring the exposure level of the vibrational energy delivered to the body part with the control unit and comparing it with a maximum exposure level such that the exposure level is limited by the maximum exposure level within a predetermined period of time; and delivering the vibrational energy to the body part so that it is within the maximum exposure level.

[0016] Another method for treating a subject may generally include generating vibrational energy from an actuator such that the vibrational energy is directed to a body part of the subject while maintaining portability of the actuator; monitoring the resulting vibrational energy transmitted to the body part of the subject with a first accelerometer positioned proximate to the body part, the first accelerometer and the actuator being in communication with a controller; and automatically calibrating the actuator with the controller by adjusting the vibrational energy until the resulting vibrational energy is within a predetermined range. [Brief explanation of the drawings]

[0017] [Figure 1] FIG. 1 is a diagram illustrating a wearable vibration device according to one embodiment of the present invention. [Figure 2A] 2A and 2B are various views illustrating a wearable vibrating device according to one embodiment. [Figure 2B] 2A and 2B are various views illustrating a wearable vibrating device according to one embodiment. [Figure 3] FIG. 3 is a top view illustrating a wearable vibrating device according to one embodiment. [Figure 4A] 4A-4C are various views illustrating a wearable vibrating device according to one embodiment. [Figure 4B] 4A-4C are various views illustrating a wearable vibrating device according to one embodiment. [Figure 4C] 4A-4C are various views illustrating a wearable vibrating device according to one embodiment. [Figure 5A] 5A-5C are various views illustrating a wearable vibrating device according to one embodiment. [Figure 5B] 5A-5C are various views illustrating a wearable vibrating device according to one embodiment. [Figure 5C] 5A-5C are various views illustrating a wearable vibrating device according to one embodiment. [Figure 6] FIG. 6 is a logic diagram illustrating the functionality of a wearable vibrating device according to one embodiment. [Figure 7] FIG. 7 is a diagram illustrating various components of a wearable vibrating device according to one embodiment. [Figure 8] FIG. 8 shows a vibration device according to one embodiment in the form of a seat cover. [Figure 9] FIG. 9 illustrates a vibration device according to one embodiment that includes a foam platform with protrusions. [Figure 10A] 10A-10C show different views of an alternative foam platform and protrusion. [Figure 10B] 10A-10C are different views of an alternative foam platform and protrusion. [Figure 10C] 10A-10C show different views of an alternative foam platform and protrusion. [Figure 11A] 11A-11C show different views of alternative foam platforms and protrusions, along with some example dimensions in inches. [Figure 11B] 11A-11C show different views of alternative foam platforms and protrusions, along with some example dimensions in inches. [Figure 11C] 11A-11C show different views of alternative foam platforms and protrusions, along with some example dimensions in inches. [Figure 12] FIG. 12 illustrates a belt of the device according to one embodiment. [Figure 13] FIG. 13 illustrates a vibration pack according to one embodiment. [Figure 14] FIG. 14 illustrates the control logic of some embodiments represented as a flow chart. [Figure 15] FIG. 15 is a block diagram illustrating a data processing system that may be used in any embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0018] FIG. 1 illustrates a wearable vibration device according to one embodiment of the present invention. This embodiment is configured to be worn around the waist to deliver vibration energy to a user's lower back or spinal region. In some embodiments, the device is worn to focus the vibration energy on the sacrum. A band 102 may be secured to the body by a fastening mechanism or strap 104. A vibration pack housing or enclosure 106 may contain components and / or electronics, such as a vibration motor, processor, battery, battery charger, voltage regulator, buzzer or alarm, motor sensor, and temperature switch. The housing 106 is secured to the band 102 and connected to a pressure sensor 112 via a connector 110. A cushioning material, i.e., foam, block, or spacer 108, can more precisely direct the vibration energy to specific areas of the user and also enhance user comfort during use of the wearable vibration device. The pressure sensor may be located above or below the foam. An accelerometer 114 monitors vibration forces transmitted through the body to determine whether the wearable vibration device is properly worn. One or more accelerometers may be embedded inside, outside, or within the band 102. The accelerometers may also assess the effect of applying vibrational forces to the user. A pressure sensor 112 may also accomplish this by measuring the pressure of the device against the body. The measured pressure is indicative of the comfort of the device.

[0019] In some embodiments, multiple pressure or force sensors are provided to detect fit. In some embodiments, an array of pressure / force sensors is provided to detect fit. Using multiple sensors allows for a more precise assessment of fit. For example, the controller can detect if the device is positioned too high, too low, too far to the left, too far to the right, too loose, too tight, or a combination thereof. The controller may also communicate to the user how to adjust the device to improve fit. The controller can instruct the user to move the device up, down, left, or right, or to tighten or loosen the device.

[0020] The fit of a wearable vibrating device is important to ensure proper function. For example, if the wearable vibrating device is too loose or too tight on the body, the appropriate amount of vibration energy may not be transferred to one or more bones, the energy may be transferred to the wrong location, or the energy may be transferred in the wrong direction. In addition, poor fit may reduce the comfort of the device's user.

[0021] To ensure proper fit, the wearable vibration device may include one or more sensors. These sensors may include, but are not limited to, one or more contact sensors, one or more pressure sensors, one or more strain gauges, one or more accelerometers, one or more gyro sensors, etc. The one or more sensors may be located anywhere on the wearable vibration device, including on the strap, band, fastening mechanism, motor, spacer, housing, etc. In some embodiments, the sensors may be physically separate from the device but may communicate with the device's controller via wired or wireless communication. Additionally, the wearable vibration device may include one or more alarms to prompt the user to adjust the fit. Various types of alarms may be used, including audio, visual (e.g., flashing lights), and tactile (e.g., pulsating vibration motors). The alarm may sound for a set period of time, until fit is improved, or both. Additionally or alternatively, the fastening mechanism of the wearable vibration device may self-adjust based on feedback from one or more fit sensors. This may be achieved using motors, thermal mechanisms, mechanical mechanisms, electrical mechanisms, etc.

[0022] Alternatively or additionally, if the wearer is not delivering optimal vibration energy, the processor of the wearable vibration device can adjust the motor movement to increase or decrease the vibration energy delivered to the user. In this way, optimal treatment vibration energy can be automatically optimized even if the fit changes during treatment.

[0023] 2A and 2B are two views illustrating a wearable vibrating device according to one embodiment. FIG. 2A shows the side of the wearable vibrating device facing away from the user. A band 202 may be secured to the body by a fastening mechanism or strap 204. A container, pouch, or pocket 206 contains a motor 212, electronics 210, and a battery 214. Bones 208 help securely hold the contents of the pocket 206 and help provide rigidity to the wearable vibrating device.

[0024] FIG. 2B shows the side of the wearable vibrating device facing the user, so that the side is in contact with the user's body. A container, pouch, or pocket 220 holds the spacer described in FIG. 1. A pressure sensor 222 detects pressure caused by vibration of the motor in the pocket 206 as well as the overall tightness of the wearable vibrating device against the user's body, i.e., a measure of fit. One or more pressure sensors can also be located in other areas of the wearable vibrating device. An accelerometer 216 is held in the pocket or slot 218 to monitor the fit of the wearable vibrating device and / or the effectiveness of the transmission of vibration forces to the user. One or more different sensors may be located at various locations on the wearable vibrating device to monitor the fit of the wearable vibrating device.

[0025] 3 is a top view of a wearable vibrating device according to one embodiment. A band 302 may be secured to the body by a fastening mechanism, or strap 304. A motor 306 and other electronics and components are housed in a container 308 within a pocket 310. A spacer 312 and a pressure sensor 314 are inside the wearable vibrating device. A bone 316 helps securely hold the contents of the pocket 310 and helps provide rigidity to the wearable vibrating device. An accelerometer 318 helps monitor the fit of the wearable vibrating device and / or the effectiveness of the transmission of vibrational forces to the user.

[0026] 4A-4C are various views illustrating a wearable vibrating device according to one embodiment. FIG. 4A shows the side of the wearable vibrating device facing away from the user. A container, pouch, or pocket 406 contains a motor 402 and a motor sensor 404. A pouch or pocket 420 contains electronics 410 and a battery 412. A rib 408 helps securely hold the contents of the pocket 406 and helps provide rigidity to the wearable vibrating device. An accelerometer 414 helps monitor the comfort of the wearable vibrating device and / or the effectiveness of the transmission of vibrational forces to the user.

[0027] FIG. 4B shows the side of the wearable vibratory device facing the user, so that the side is in contact with the user's body. A container, pouch, or pocket 418 holds the spacer described in FIG. 1. A pressure sensor 416 detects pressure caused by vibration of the motor in the pocket 406, as well as a measurement of the overall tightness of the wearable vibratory device against the user's body. One or more pressure sensors may be located in other areas of the wearable vibratory device. An accelerometer 414 is for monitoring the comfort of the wearable vibratory device and / or the effectiveness of the transmission of vibrational forces to the user.

[0028] FIG. 4C is a bottom view of the device of FIGS. 4A and 4B.

[0029] 5A-5C are various views illustrating a wearable vibrating device according to one embodiment.

[0030] FIG. 5A shows the side of the wearable vibrating device facing the user, such that the side is in contact with the user's body. In this embodiment, a spacer device 506 holds the motor 504, electronics 502, and battery 510. The pressure sensor 508 is outside the spacer and therefore in contact with the user. The pressure sensor 508 senses the pressure caused by the motor's vibrations as well as a measure of the overall tightness of the wearable vibrating device against the user's body before, during, or after the motor is turned on. One or more pressure sensors can also be located in other areas of the wearable vibrating device. This embodiment allows for a more compact device.

[0031] Figure 5B is a top view of the device of Figure 5A. Figure 5C shows the side of the wearable vibrating device facing away from the user.

[0032] FIG. 6 is a logic diagram illustrating the functionality of a wearable vibration device according to one embodiment. First, the device is powered on, represented by box 602. The processor then checks for faults, represented by box 604. Several components are checked, including the battery and electronic communications. If any faults exist, the processor transitions to a fault handler box 622. For example, at startup, a single fault is sufficient to trigger the fault handler, but during operation, multiple faults must occur consecutively or within a certain time frame to trigger the fault handler. If no faults exist, the processor transitions to a treatment state, represented by box 606. Entering the treatment state may include starting a treatment timer, starting the motors at nominal values, and may also include other processing. In the treatment state, the processor may intermittently or continuously acquire data such as motor motion, device fit, and motion frequency. This is represented by box 608. The fit may include feedback from one or more sensors, such as, but not limited to, one or more contact sensors, one or more pressure sensors, one or more strain gauges, one or more accelerometers, and one or more gyroscopes. Motor motion and motor frequency are measured by the motor sensors. It is also contemplated that instead of or in addition to evaluating fit after turning on the motor, fit may be evaluated before turning on the motor.

[0033] If the motor motion is not within the appropriate range, a motor malfunction is triggered, as represented by box 610. The appropriate range may be preset or may be based on the user's weight, height, age, gender, etc., as well as the type, location, and duration of the procedure. Alternatively, the appropriate range may be dynamically set based on the comfort of the wearable vibration device and other factors. If the motor motion is impaired, a buzzer, alarm, visual light, or other alarm may be displayed.

[0034] If the fit is not within an appropriate or optimal range, a fit fault or warning, represented by box 616, is triggered. 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 in advance or may be dynamically set based on the fit of the wearable vibration device and / or other factors. The processor may periodically check the fit. For example, if the fit check returns two or more consecutive fit faults, a fit warning handler may be triggered. The fit warning handler is represented by box 618. An abnormal fit may trigger an alert via a vibration motor pulse, an audible buzzer or alarm, a visible light, and / or other warning.

[0035] After hearing, feeling, seeing, or otherwise perceiving the fit alert, the user may adjust the fit of the wearable vibration device, as represented in box 614, and / or the processor may adjust the motor's motion. In response to the fit alert, motor parameters such as frequency and amplitude may be adjusted to optimize treatment. Adjustments to motor parameters may be continuous checks that occur in a normal code loop. For example, if the motor frequency changes for some reason (fit, movement, activity, posture, time, etc.) and falls outside a predetermined window away from a predetermined frequency (e.g., 30 Hz) for a timer or counter, the motor may self-adjust to compensate for the frequency error.

[0036] As the treatment progresses, the processor continuously or intermittently checks the treatment timer represented by box 612. If the treatment time has expired, the processor proceeds to box 620 and terminates the treatment. If the treatment time is incomplete, the processor of the wearable vibration device continues the treatment and continues acquiring movement, fit, and / or other data until the treatment has ended.

[0037] Figure 7 illustrates various components of a wearable vibration device according to one embodiment. A processor 702, including control electronics, is located on a circuit board 704. The circuit board, along with other components, is located within a housing 706, for example, similar to housing 106 of Figure 1. Also mounted on the circuit board is a buzzer 708, a battery charger 722, and a voltage regulator 724 connected to the battery. Also located within the housing are a battery 712, a motor 728, a motor sensor 726, and a temperature switch 730 connected to the motor. A charging port 714 is located on a wall of the housing or container to allow access for charging the battery.

[0038] Other components are provided on the exterior of the housing, including a power switch 720, a charging LED 718, a status LED 710, and optional wearability sensor(s), including but not limited to one or more contact sensors, one or more pressure sensors 734, one or more strain gauges, one or more accelerometers 732, and one or more gyroscopes.

[0039] Embodiments for treating other body parts are also contemplated. For example, vibrations may be applied to the foot through a device such as a shoe or sock, or a device that is attached to the foot or leg by a strap or the like. Applying vibration stimulation to the foot or leg may assist in the treatment of conditions such as osteoporosis.

[0040] It has also been shown that applying vibrations to the soles of the feet can improve sensation, balance, and / or reduce gait variability. The vibration sound or energy may be subsensory or felt by the wearer. As with other embodiments, the vibrations may be applied periodically, continuously, or in other forms.

[0041] Although embodiments have been described herein, other embodiments are contemplated. For example, a wearable vibration device may be configured to be worn on other parts of the body, such as the neck, back, limbs, or head. The vibration energy may be configured to be directed in different directions, multiple directions, alternating directions, or different directions simultaneously. Multiple vibration motors may be present within a device, allowing for greater flexibility in directing the vibration energy in terms of direction, body part, etc. The vibration energy may vary over time, such as increasing or decreasing amplitude, increasing or decreasing frequency, changing direction, cycling through programs, or being turned on or off. The stimulation vibration may also incorporate different types of waveforms, such as square, triangular, sawtooth, or sinusoidal waveforms. These different waveforms may introduce harmonics of the fundamental frequency, providing enhanced or additional benefits. The vibration element may also have multiple superimposed frequencies. Multiple vibration motors may be worn on different parts of the body. Multiple wearable vibration devices may be worn. Multiple vibration motors may be used to cancel, enhance, or modify some or all of the vibration energy provided to the user. Vibration energy may be transmitted percutaneously to the implanted metal plate. For example, a vibration device may be placed on the outer surface of the leg to vibrate the metal bone plate within the leg and reduce bone necrosis around the plate. This device may be used periodically, possibly once a day, once a week, or once a month, to reduce bone necrosis.

[0042] The wearable vibration device according to the embodiment is used for SI (sacroiliac joint) syndrome, SI joint arthropathy, SI joint instability, SI joint obstruction, pelvic region muscle pain and tendonitis, pelvic ring instability, and also for preventing recurrence of SI joint obstruction and muscle tendinopathy (rectus abdominis, piriformis adductor) in cases of structural damage after lumbar fusion surgery, sympathetic nerve transection and relaxation, lower back pain, cartilage strengthening, and other symptoms.

[0043] FIG. 8 illustrates one embodiment of a vibration device in the form of a seat cover or pad. This embodiment includes a pad 802, which may incorporate a layer of foam or other padding, and a vibrating plate 804 connected to a controller. The plate may be metal, polymer, or any other suitable material. Preferably, the plate is rigid or semi-rigid. To maximize the transfer of vibration energy from the plate to the bone, the plate may be shaped like a "cup" around the hip bone. The controller, which may be integrated into the pad or a separate device, controls the plate via a wireless or wired connection. The user places the seat pad / cover on a chair or other surface and sits on the seat pad so that the hip bones, including the protruding bones that make up the ischial bones, are in contact with or nearly in contact with the plate. The plate may have a padded cover between it and the user. Vibration energy is transferred from the plate to the ischial bones and then throughout the skeleton, transferring vibration energy to the lower back and hip joints. The vibration energy may be horizontal, vertical, or both. In this embodiment, the user's weight can be used to properly "fit" the device to the body. However, as with other embodiments, an accelerometer can also be used to assess "fit." In some embodiments, the accelerometer readings can be correlated with treatment outcomes to determine preferred accelerometer readings. A controller can control the vibration and force of the vibrating device to optimize the accelerometer readings. The pads can also be secured to the user's body using straps or other connections.

[0044] The vibration device may also be in the form of a back pad similar to that shown in Figure 8, but intended to rest against the back of a chair so that the plate portion of the device contacts the hip bone, e.g., the ilium. In this embodiment, a strap may be included to bring the vibration device closer to the hip bone area.

[0045] The vibration device may also be in the form of a weighted lap pad having a vibrating plate portion adjacent the iliac crest region of the hip bones.

[0046] Vibration treatment may also be performed at forces and frequencies to treat constipation and other digestive disorders.

[0047] FIG. 9 illustrates a vibration device according to one embodiment, including a foam platform 902 with foam protrusions 904. While the protrusions are shown here as tapered squares, they may also be rectangular, circular, oval, rounded, etc. The protrusions may or may not be tapered. The protrusions may occupy a small portion, a large portion, or substantially all of the surface area of ​​the platform. The foam platform and protrusions are configured to enhance user comfort, increase the likelihood of proper placement on the sacrum, and facilitate the transfer of vibration energy from the motor to the patient's sacrum. The platform and / or protrusions may be formed from a high-density polymer foam, such as cross-linked polyethylene foam. An example is cross-linked PE foam. Cross-linked PE foam:

[0048] [Table 1]

[0049] 10A-10C show different views of an alternative foam platform and protrusion.

[0050] 11A-11C show different views of alternative foam platforms and protrusions, along with some example dimensions in inches.

[0051] Figure 12 illustrates the belt of the device according to one embodiment. The shape and construction of the belt are intended to maximize patient comfort while transferring vibrations from the puck to the patient. A parabolic contour may be used to provide a more conforming fit. When worn, the belt fits snugly around the waist with a wider belt at the hips. Additionally, this contour facilitates proper belt placement.

[0052] The belt itself may be made of multiple layers of neoprene with various fasteners, stays (nylon loops), zippers, and pockets. Each neoprene layer may be laminated with a thin nylon fabric on both sides. A middle structural layer 1204, approximately 3 mm thick, supports most of the vibration pack's weight and provides some rigidity. The outer and inner neoprene layers 1202 and 1206 may be approximately 1 mm thick. After lamination, the ends can be secured together with thin nylon strips during assembly. The stretchy neoprene and nylon materials allow for optimal conformity to various body types and are suitable for use in clothing and sporting goods that come into contact with the skin. Patients may be instructed to wear the belt over their clothing. Also shown in Figure 12 are an accelerometer pocket 1210, a hidden zipper opening 1212, and a user interface board pocket 1208. The user interface board may include an on / off button, battery level indicator, alarm indicator, and can be used for various parameters such as comfort, treatment time, treatment level, and treatment limit.

[0053] Final assembly of the belt can be completed using the rear access zipper 1212. The vibration pack can be rigidly secured to the intermediate structural layer by compressing the intermediate layer between the vibration pack and the metal plate. Once assembly is complete, the zipper can be locked in place to prevent access to the components and wiring.

[0054] The three belt sizes were chosen based on the average waist size of women in the United States. The average waist size for women aged 46 to 66 years or older, the target size for this device, is approximately 44 inches (approximately 111.76 centimeters), with a standard deviation of approximately 4.5 inches (approximately 11.43 centimeters). Therefore, assuming a normal distribution, a device size (available in three sizes) from 35 to 54 inches (approximately 88.9 to 137.16 centimeters) would accommodate approximately 95% of American women.

[0055] The vibration puck generates vibrations using a PWM (Pulse Width Modulation) controlled electric eccentric rotating mass motor. The rotational speed, and therefore the vibration amplitude, can be adjusted by changing the motor PWM duty cycle (motor frequency and vibration amplitude are approximately linearly proportional over the motor frequency range of 15-50 Hz). The motor is attached to the puck and oriented within the puck to transmit vibrations to the patient primarily in the sagittal plane (x- and z-axes, with the z-axis parallel to the patient's height / body length axis).

[0056] 13 illustrates a vibration pack according to one embodiment. Shown are a battery 1302, a lower half of a housing 1304, a printed circuit board assembly (PCBA) 1306, screws 1308, an upper half of a housing 1310, a motor 1312, screws 1314, screws 1316, a motor mounting plate 1318, a backplate 1320, a belt mounting screw 1322, and a pressure or force sensor 1324. The housing may be constructed from Acrylonitrile Butadiene Styrene Plastic (ABS). The plate may be a 0.1 inch (approximately 2.54 mm) aluminum plate.

[0057] The vibration pack is attached to the belt via a backplate 1320. The belt's neoprene is sandwiched between the backplate 1320 and the motor mounting plate 1318 with six screws.

[0058] The vibration pack-to-patient interface (between the backplate and the patient) may be padded with a 0.5-inch (approximately 1.27 cm) section of high-density polyethylene foam. This foam provides additional comfort for the belt and also increases the contact area between the vibration pack's force sensors and the patient's body. Additionally, the foam serves as a marker for the belt, ensuring proper placement on the patient's sacrum. Due to the foam's high density, it does not significantly dampen the vibrations transmitted to the body, which is important for achieving the desired therapeutic levels.

[0059] The illustrated vibration pack also includes a PCBA containing device control hardware such as a microprocessor, RTC (real-time clock), motor control chip, charging chip, accelerometer, flash memory chip, and Bluetooth Low Energy (BLE) module, as well as supporting hardware such as voltage regulators and operational amplifiers. Motor performance is monitored by the onboard motor control chip, which includes safety features such as a current sensor that electronically reduces the motor speed if an excessive current is drawn. A backup safety feature is a hardware fuse that trips and shuts down the device if the current exceeds 2.2A.

[0060] The vibrational energy may have a frequency of about 30 to 90 cycles per second (Hz). Other frequency ranges include 1 to 100 Hz, and subranges such as 25 to 35 Hz, 20 to 40 Hz, and 10 to 50 Hz, including specific frequencies therein, such as about 30 Hz, about 20 Hz, about 10 Hz, and about 4 Hz. The intensity may be between 0.01 g and 10 g (where 1.0 g = Earth's gravitational field = 9.8 m / s), and other subranges, such as 0.01 g to 4.0 g, including specific magnitudes therein, such as about 0.3 g or about 1.0 g.

[0061] The vibration device may include multiple sensors to monitor device usage and performance. An accelerometer can be embedded within a neoprene belt located approximately above the patient's right iliac crest during wear. This accelerometer can be used to quantify acceleration transmission from the pack to the patient and adjust the motor speed to ensure the transmitted vibration falls within a safe and treatable range. A second accelerometer may be placed on the PCBA proximal to the motor and used to directly monitor motor activity. The accelerometer utilizes MEMS (microelectromechanical systems) technology, making it extremely compact and reliable. The digital sensor has a maximum range of ±16 g (although in practice it is set to ±4 g for increased sensitivity) and a high-resolution data rate of up to 1.6 kHz.

[0062] To ensure the belt is tight enough for proper vibration transmission to the patient, a force or pressure sensor can be placed at the interface between the patient and the pack (behind the foam pad in this embodiment) to monitor the pack force against the sacrum. If the belt is not tight enough before activating the motor, or if the belt tightens below a threshold during use, the motor may not activate or may stall during use, respectively.

[0063] The vibration device may have an "auto-calibration" feature to ensure that the patient receives a safe and therapeutic level of vibration with each use. A feedback loop may read the value of a belt-mounted accelerometer, identify whether the value is within a specified window, and increase or decrease the power supplied to the motor until the belt-mounted accelerometer reads within the specified window. Figure 14 illustrates the control logic of some embodiments, represented as a flow chart.

[0064] As shown in FIG. 14, the controller can manage when the waist accelerometer readings are artificially low (e.g., when the belt is not attached to the body) or artificially high (e.g., when the patient jumps). The controller checks whether the waist accelerometer value matches the expected motor accelerometer value before proceeding to adjust the motor power. Box 1402 represents the controller checking the acceleration sensed by the waist accelerometer. If the value is below a threshold, e.g., 0.1 g, as shown in box 1404, the controller checks the motor acceleration in box 1410. If the motor acceleration is above a threshold, e.g., 4 g, the controller issues an error instructing the user to reposition the device and try again, as represented by box 1418. If the motor acceleration is below a threshold, e.g., 4 g, the controller can increase the motor speed by, e.g., 5% of the duty cycle, as shown in box 1416.

[0065] If the hip acceleration exceeds a threshold, e.g., 0.3 g, as represented by box 1408, the controller can check the motor acceleration, as represented by box 1414. If the motor acceleration is below a threshold, e.g., 1 g, the controller can issue an error instructing the user to reposition the device and try again, as represented by box 1420. If the motor acceleration is above a threshold, e.g., 1 g, the controller can reduce the motor RPM by, e.g., 5% of the duty cycle, as shown in box 1422.

[0066] If the acceleration measured at the hips is between two thresholds, e.g., 0.1 g and 0.3 g, as represented by box 1406, the controller will maintain the motor speed, as shown in box 1412.

[0067] If the belt readings and motor readings do not match (acceleration ratio (motor:belt) less than 2.0 or greater than 25.0), the system will not proceed and will instruct the patient to reposition the belt and remain stationary for a short calibration process. Additionally, to reduce the impact of noise in the accelerometer data due to patient movement during the calibration process, the data can be filtered in real time to obtain the most accurate reading. If the lumbar accelerometer readings (before calibration) fall outside the specified range over continuous use (indicating inconsistent device use / not following device instructions), the device can alert the patient to seek additional training / technical support.

[0068] Patients can control the device through a simple user interface (UI) on the front of the belt or through a remote control such as a mobile phone, PC, or tablet. For example, a power button can be used to turn the device on and off. Two light-emitting diodes (LEDs) indicate normal operation and alert patients to recommended actions (e.g., fastening the belt or charging the device) or any issues with the device, prompting them to contact technical support. Additionally, a speaker in the vibration pack provides audio notifications of changes in the situation that require the patient's attention.

[0069] The vibration device can be configured to include elements such as sensors to ensure proper belt application, thereby mitigating potential safety risks and ensuring effectiveness.

[0070] Sensor for proper belt wearing.

[0071] A force or pressure sensor may be located on the patient side of the pack, such as between the pack and the foam. This force sensor ensures that the belt is tight enough to effectively transmit vibrations to the patient, but not too tight to cause discomfort when wearing the device. The optimal reading range for the force sensor for belt comfort may be between 12.2N and 20N. If this range is used, the force reading must be within this range before the device motor will begin a treatment session. During treatment, if the force reading is outside this range for more than 30 seconds, the motor will shut off and the belt tightness must be adjusted back into range to continue treatment.

[0072] Automatic shut-off at the end of a treatment session: The vibration device has a built-in timer that automatically shuts off the motor after 18 minutes (or other set time, such as 20, 30, etc.) of treatment. This ensures patients receive the correct treatment every day without being overexposed to vibrations.

[0073] Preventing Overuse. To ensure that patients do not self-treat too frequently and become overexposed to vibrations, the vibration device's controls may limit the total treatment time to 18 minutes (or other set time) per calendar day. If the patient manually terminates the device before the set treatment time ends, or if the force sensor reading goes out of range during treatment and the device automatically stops, the patient may begin another treatment on the same calendar day, but the device may automatically stop when the total cumulative treatment time for that day reaches 18 minutes.

[0074] Automatic adjustment of vibration amplitude at the beginning of each treatment. While components of the vibration device are designed to standardize the vibration transmitted from the motor to the patient, multiple patient factors can affect this transmission. These factors include patient anatomical parameters, such as body shape, size, composition, and weight, which vary between and within individuals over time, as well as variations in daily belt wearing, which can affect belt tightness. The applied vibration can be adjusted at the beginning of each treatment session to ensure the vibration dose delivered to the patient is consistent and safe and effective / therapeutic for its intended use. The vibration dose can be varied by changing the motor frequency (e.g., within a range of 20 to 40 Hz). The vibration dose can be measured with a belt-type accelerometer placed on the patient's right iliac crest. When the patient dons the vibration device, the motor starts at the previous frequency, and the control unit can measure the vibration amplitude. If the measured vibration amplitude is outside the specified range (e.g., 0.03 to 0.10 g, RMS (root mean square)), the frequency is gradually increased or decreased, such as by 5 Hz, and the vibration amplitude is measured again. This continues until the measured vibration magnitude falls within a specified range. If the frequency reaches a limit without reaching the specified range, the device will shut off, a warning light on the device will flash, and the patient will be directed to troubleshooting guidance.

[0075] Maximum safe daily exposure. ISO 2631-1 provides guidelines for safe levels of vibration transmitted to the body through the supporting structure by people (e.g., heavy machinery operators, factory workers) who stand or sit for 4 to 8 hours per day. ISO 2631-1 also includes guidelines for shorter exposure periods and extrapolation to other vibration applications.

[0076] ISO 2631-1, which is incorporated herein by reference in its entirety, provides guidelines for calculating equivalent vibration exposure values ​​depending on several factors, including the magnitude of acceleration in three orthogonal directions, the frequency of vibration, and the subject's position during exposure.

[0077] Maximum safe daily exposure

[0078] The maximum safe daily exposure is calculated based on both the treatment time and the motor frequency level. To maintain below the maximum safe exposure, the vibration device's control unit can limit the duration and frequency of a user's exposure over a 24-hour period. That is, the vibration device's control unit can limit cumulative vibration exposure to ensure that a person's cumulative 24-hour vibration exposure is below the recommended maximum, taking all relevant parameters into account. To do so, the control unit may set a maximum cumulative exposure time over a 24-hour period, taking into account the motor frequency. Alternatively, the control unit may only limit cumulative exposure time within a 24-hour period to approximately 18 minutes, approximately 20 minutes, or approximately 30 minutes. The control unit can limit exposure by disabling the device for 24 hours once the limit is reached. Alternatively, or in addition, the device may warn the user that a limit has been reached. The device will resume functioning after 24 hours have elapsed. The cumulative time limit can be 15-20 minutes, 20-30 minutes, 30-40 minutes, 40-60 minutes, etc. The motor frequency may or may not be taken into account when determining these limits. Other factors that may be taken into account and input into the system's controller include parameters sensed by any sensors on the system, including accelerometers, pressure or force sensors, etc. For example, if a 30-minute vibration exposure is 0.330 g RMS (approximately 0.7 x peak-to-peak for a sinusoidal signal), the vibration device may be adjusted (using the sensor information) to deliver vibrations on the order of 0.1 to 0.3 g peak-to-peak. Alternatively, a sensor may be monitored to measure the transmitted vibration, and the controller may limit the exposure time accordingly.

[0079] Data Processing System Example

[0080] FIG. 15 is a block diagram illustrating a data processing system that may be used in any embodiment of the present invention. For example, system 1500 may be used as part of a processor. Note that while FIG. 15 illustrates various components of a computer system, it is not intended to represent the particular architecture or manner of interconnecting the components; such details are not relevant to the present invention. It will also be understood that network computers, handheld computers, mobile devices, tablets, mobile phones, and other data processing systems having fewer or perhaps more components may also be used in conjunction with the present invention.

[0081] As shown in Figure 15, computer system 1500, which is one form of data processing system, includes a bus or interconnect 1502 coupled to one or more microprocessors 1503 and ROM 1507, volatile RAM 1505, and non-volatile memory 1506. Microprocessor 1503 is coupled to cache memory 1504. Bus 1502 interconnects these various components and also interconnects these components 1503, 1507, 1505, and 1506 to a display controller and display device 1508, as well as input / output (I / O) devices 1510, which may be a mouse, keyboard, modem, network interface, printer, and other devices known in the art.

[0082] Input / output devices 1510 are typically coupled to the system via an input / output controller 1509. Volatile RAM 1505 is typically implemented as dynamic RAM (DRAM), which requires continuous power to refresh or maintain data in memory. Non-volatile memory 1506 is typically a type of memory system that retains data even when power is removed from the system, such as a magnetic hard disk, a magneto-optical drive, an optical drive, or DVD RAM. Non-volatile memory is typically random access memory, although this is not required.

[0083] While FIG. 15 illustrates an embodiment in which the non-volatile memory is a local device directly coupled to the remaining components in the data processing system, the present invention may also utilize non-volatile memory that is remote from the system; for example, a network storage device coupled to the data processing system via a network interface, such as a modem or Ethernet interface. Bus 1502 may include one or more buses connected to each other through various bridges, controllers, and / or adapters, as is well known in the art. In one embodiment, I / O controller 1509 includes a Universal Serial Bus (USB) adapter for controlling USB peripherals. Alternatively, I / O controller 1509 may include an IEEE-1394 adapter, also known as a FireWire adapter for controlling FireWire devices, SPI (Serial Peripheral Interface), I2C (Inter-Integrated Circuit), or UART (Universal Asynchronous Receiver / Transmitter), or any other suitable technology. Wireless communication protocols may include Wi-Fi, Bluetooth, ZigBee, short-range wireless, cellular, etc.

[0084] Some portions of the detailed descriptions set forth above 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 means 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, as used herein, is 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.

[0085] 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. As is clear from the above discussion, unless otherwise specifically stated, throughout this specification, discussions utilizing such terms as set forth in the claims will be understood to refer to the acts and processes of a computer system or similar electronic computing device that manipulate and transform data represented as physical (electronic) quantities in the computer system's registers and memory into other data similarly represented as physical quantities in the computer system's memory or registers or other such information storage, transmission, or display device.

[0086] The illustrated techniques may be implemented using code and data stored and executed on one or more electronic devices that may store and communicate (internally and / or with other electronic devices over a network) the 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 transient computer-readable transmission media (e.g., electrical, optical, acoustical or other forms of propagated signals—carrier waves, infrared signals, digital signals, etc.).

[0087] The processes or methods depicted in the preceding figures may be performed by processing logic comprised of hardware (e.g., circuitry, dedicated logic, etc.), firmware, software (e.g., embodied on a non-transitory computer-readable medium), or a combination of both. While the processes or methods are described above in terms of several sequential operations, it should be understood that some of the described operations may be performed in a different order. Furthermore, some operations may be performed in parallel rather than sequentially.

[0088] Any feature of any embodiment disclosed herein may be used in combination with other embodiments.

Claims

[Claim 1] 1. A vibration device for treating a subject, comprising: an actuator configured to generate vibrational energy; a fixation mechanism for positioning the actuator on the subject's body while maintaining portability so that the vibration energy generated by the actuator is directed to a region of the subject's body to be treated; an accelerometer disposed along the securing mechanism; a control unit in communication with the actuator and the accelerometer, the control unit being programmed to: acquire an acceleration of the accelerometer when measuring an exposure level of the vibration energy to the part of the body; measure the exposure level using the acceleration acquired from the accelerometer; and compare the exposure level to a maximum exposure level such that the exposure level is limited by the maximum exposure level within a predetermined time period; A vibration device comprising:

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