Vibration device for treating osteoporosis and increasing bone strength and bone density

Abstract

A vibration device for treating osteoporosis and increasing bone strength and bone density, comprising at least one random vibration unit (3). The random vibration unit (3) is configured to produce mechanical vibration, and the mechanical vibration comprises random vibration; and the mechanical vibration is configured to apply a mechanical load to a user at a frequency and an acceleration that produce a therapeutic effect on osteoporosis. The vibration device can be used for treating or preventing osteopenia and osteoporosis, stimulating bone growth, and maintaining or enhancing bone density or bone strength.

Description

A vibration device for treating osteoporosis and increasing bone strength and bone density Technical Field

[0001] The present invention relates to the field of medical devices, and more particularly to a vibration device for treating osteoporosis and increasing bone strength and bone density. Background Art

[0002] Osteoporosis is a disease characterized by low bone density, deterioration and destruction of bone microarchitecture, impaired bone strength, decreased bone mass, and predisposition to fractures. In my country, osteoporosis is severely underdiagnosed and undertreated. Therefore, there is a significant unmet need for effective prevention and mitigation of bone loss, promotion of bone growth and healing, and repair of bone damage.

[0003] Currently, osteoporosis is treated with medication, diet therapy, and exercise. However, medication and diet therapy require long treatment times, have limited remission rates, and require high patient compliance. Medication therapy can also easily trigger gastrointestinal reactions and even tumors. Exercise therapy, on the other hand, has garnered particular attention due to its health, effectiveness, and convenience. Exercise is proven to be effective in improving osteoporosis and is included in osteoporosis prevention and treatment guidelines. Its mechanism stems from the mechanical vibrations generated by exercise stimulating bone cells. By transmitting mechanical signals, osteoblasts proliferate, enabling adaptive bone remodeling and regulating bone anabolism. However, exercise therapy has its limitations and is not suitable for individuals with limited mobility or cardiopulmonary disease. In addition, improper exercise can lead to injuries in healthy individuals. Therefore, providing the body with passive mechanical vibrations, as an alternative to active exercise, to prevent osteoporosis and bone calcium loss has potential applications. It has been reported that Soviet cosmonauts used vibration technology to combat muscle atrophy and bone calcium loss caused by weightlessness in space, enabling them to safely remain in space for over 420 days, compared to the then-record for American astronauts, which was just over 120 days. SU1344356A1 states that the optimal amplitude for vibration stimulation is 2-5 mm and the frequency is 25-60 Hz. In 1999, Power Plate improved and developed this technology, making it suitable for both athletes and ordinary fitness enthusiasts, and pioneered its application in the field of rehabilitation medicine (Journal of Sports Sciences, 1999, 17, pp. 177-182.). It uses whole-body vibration to allow the subject to stand on the vibration device to receive mechanical stimulation. In 2001, APOS MEDICAL ASSETS LTD. disclosed a wearable vibration device whose vibration element vibrates at a frequency in the range of approximately 1-200 Hz, inducing strain in the bone tissue in the range of approximately 1-500 microstrains (US7462158B2). BONE HEALTH TECHNOLOGIES, INC. has added an acceleration sensor to the wearable vibration device, applying 0.3-1.5g vibration stimulation to the patient's sacrum within a frequency range of 15-90Hz (US10206802B2).

[0004] The mechanism of mechanical vibration in bone tissue to stimulate osteogenesis is very complex, and changes in any parameters may lead to differences in treatment effects. In current literature and applications, the focus is on parameters such as the frequency, acceleration, treatment duration, and interval of mechanical vibration. For example, Zhang Jianguo et al. found that vibration stress with a frequency between 0.5-1 Hz can not only promote new bone formation and prevent osteoporosis, but also promote fracture healing, promote callus growth, and increase the strength and stiffness of the fracture healing site (Image analysis of the effect of cyclic load on experimental fracture healing, Chinese Journal of Orthopaedics, 1995, 4); 220-223). Shen Hua et al. believe that the optimal frequency for vibration stress to promote bone reconstruction should be 10-50 Hz, and that the structural characteristics and material properties of callus grown under the stimulation of this frequency are better (Biomechanical experimental study on the optimal frequency of vibration stress to promote bone reconstruction, Chinese Medical Journal, 2000, 80(10): 795-796). These studies conducted in-depth comparisons and research on vibration frequency, amplitude, treatment duration and interval, and each came up with what they considered to be the optimal vibration stimulation conditions.

[0005] However, without exception, the existing technologies have not paid attention to the impact of the vibration type itself on bone growth. In these documents and actual applications, the vast majority use deterministic vibrations, that is, periodic vibrations or quasi-periodic vibration modes. Most of them apply vibrations to the object at a regular rated frequency, and a small part applies vibrations in a periodic, small-amplitude variable frequency manner. The vibration intensity used is also mostly fixed. In life, whether exercising or engaging in other activities, the human body is actually exposed to a state of random vibration. Mechanical stimulation containing random vibrations is closer to the vibration mode of the natural state. In addition, bone cells will also experience sensitivity fatigue under long-term single periodic vibration stimulation. At this time, the response of bone cells to mechanical stimulation will decrease, and the anabolism capacity will be weakened, affecting the treatment effect.

[0006] Furthermore, because different people vary in gender, age, genetic background, life experience, medical history, and underlying bone conditions, their bone conditions vary greatly, and therefore their response to vibration stimulation is different. A uniform, monotonous vibration type cannot guarantee a response in all people. Therefore, a more universal and fatigue-resistant vibration solution is needed to ensure that more subjects with different bone conditions respond to vibration stimulation and thus benefit.

[0007] There is a need in the art to provide a vibration device that can overcome the deficiencies of the prior art.

[0008] Summary of the Invention

[0009] The present invention is proposed in view of the above-mentioned problems, and its purpose is to provide a vibration device for treating osteoporosis and increasing bone strength and bone density. The device stimulates bone tissue growth, helps bone tissue healing, prevents osteoporosis, slows down or inhibits the occurrence of bone loss, and maintains or increases bone density and bone strength by giving the subject mechanical stimulation including random vibration.

[0010] The random vibration described in this invention is random vibration in the commonly known sense. Mechanical vibration is categorized into two main types: deterministic and random. These types are based on the characteristics of the vibration's variation over time. Random vibration is the relative term to deterministic vibration. If the value or amplitude of the force or motion acting on a system is constant at any given time, the vibration generated by this force or motion is considered deterministic vibration. Random vibration, on the other hand, refers to a system where the value or amplitude of the force or motion is unpredictable at any given time.

[0011] The present invention adopts a mode including random vibration to replace the existing fixed-frequency and regularly variable-frequency vibration stimulation mode of bone growth. This is because the human body is always in a living environment including random vibration. In the long-term evolution process, the mechanical stimulation generated by random vibration is the most natural state for regulating the physical signal pathways on bone cells. In daily life, wind speed, road roughness, and ground movement during earthquakes are all random vibrations; the human body also contains random vibrations when it is free to move and exercise, such as running, cycling, and skipping rope. Although the vibration types of artificial facilities such as mechanical equipment include deterministic vibrations, they still inevitably contain random vibrations, or a combination of several types of vibrations. In actual operation, the periodic signal of the equipment is often submerged in the random vibration signal.

[0012] A single, periodic, regular vibration stimulation mode will cause fatigue in the response of bone cells, thereby reducing the effect of bone growth. Signals containing random vibrations can give the physical signal pathways of bone cells a more lasting growth stimulation, and are also more suitable for various people in different situations. The present invention obtains a vibration device that can treat osteoporosis, promote bone tissue growth, reduce bone loss, and promote fracture healing by adopting a vibration method containing random vibrations. In the animal osteoporosis model, it was found that the random vibration treatment mode was superior to the periodic vibration treatment mode in all detection indicators, and there were statistical differences in improving bone mineral content and increasing the connection density of trabeculae, achieving unexpected technical effects.

[0013] One aspect of the present invention provides a vibration device including at least one random vibration unit, wherein the random vibration unit is configured to generate mechanical vibration, wherein the mechanical vibration includes random vibration.

[0014] In some embodiments, the mechanical vibration is configured to apply a mechanical load to the user at a predetermined frequency and acceleration that is capable of producing a therapeutic effect on osteoporosis.

[0015] The random vibration of the present invention includes all types of random vibrations that meet the well-known definition, including but not limited to stationary random vibration and non-stationary random vibration. The former can be further subdivided into narrow-band random vibration and wide-band random vibration.

[0016] In some embodiments, the random vibration unit generates only random vibration, ie, completely random vibration, and the random vibration can be selected from stationary random vibration or non-stationary random vibration.

[0017] In some preferred embodiments, the random vibration is selected from stationary random vibration.

[0018] In a more preferred embodiment, the random vibration is a narrowband random vibration or a broadband random vibration, more preferably a broadband random vibration. A representative type of broadband random vibration is white noise, such as Gaussian white noise.

[0019] In some embodiments, the vibration device encodes and stores random vibration data, such as Gaussian white noise data, and uses a random vibration generator to enable the vibration element to generate corresponding random vibrations, and outputs the random vibrations to the object to achieve the purpose of stimulating bone tissue growth and preventing osteoporosis.

[0020] The random vibration generation methods disclosed in the prior art can be used in the random vibration scheme of the present invention. For example, references and books can be made:

[0021] Reference 1: Wang Yongde and Wang Jun, Fundamentals of Random Signal Analysis. 5th edition, Publishing House of Electronics Industry, March 2020.

[0022] Reference 2: Zhu Hua, Huang Huining, Li Yongqing, and Mei Wenbo (eds.). Random Signal Analysis. Beijing: Beijing Institute of Technology Press, July 2021.

[0023] Reference 3: Wang Shikui, ed. Random Signal Analysis: Theory and Practice. Nanjing: Southeast University Press, August 2016.

[0024] Reference 4: Christian Lalanne (France); translated by Li Zhiqiang. Random Vibration. Beijing: National Defense Industry Press, April 2021.

[0025] Reference 5: Yin Xiangchao, ed. Vibration Theory and Testing Technology. Xuzhou: China University of Mining and Technology Press, March 2017.

[0026] Reference 6: Christian Lalanne (France); translated by Wu Sa and Ye Jianhua. Mechanical Vibration and Shock Analysis: Sinusoidal Vibration, 3rd Edition.

[0027] Beijing: National Defense Industry Press, April 2021.

[0028] In some embodiments, the mechanical vibration simulates the vibration generated by human body movement, and in this case, the random vibration unit (3) generates a combination of random vibration and deterministic vibration. The random vibration can be any of the above types, and the deterministic vibration can be periodic vibration, including but not limited to sine vibration, cosine vibration, or alternation of the two; non-periodic vibration can also be used.

[0029] One type of implementation of the combination of random vibration and deterministic vibration is to use a simulated motion mode, that is, the vibration device encodes and stores the data of vibrations generated by the human body during regular walking, jogging, sprinting, climbing, skipping, cycling, etc., and uses a random vibration generator (908) to make the vibration element vibrate, so as to achieve the purpose of stimulating bone tissue growth and preventing osteoporosis.

[0030] The implementation method of the combination of random vibration and deterministic vibration can also adopt a custom mode. In this mode, the vibration device can collect vibration information of the user in sports environments such as walking, jogging, sprinting, climbing, skipping, cycling, etc. in real time, encode and store the generated vibration data, and obtain a vibration scheme suitable for the specific user. The random vibration generator is then used to make the vibration element vibrate, so as to achieve the purpose of stimulating bone tissue growth and preventing osteoporosis.

[0031] Known methods in the prior art can be used to generate the deterministic vibration of the present invention, such as:

[0032] Reference 6: Christian Lalanne (France); translated by Wu Sa and Ye Jianhua. Mechanical Vibration and Shock Analysis: Sinusoidal Vibration, 3rd Edition.

[0033] Beijing: National Defense Industry Press, 2021.04.

[0034] The frequency range of the vibration energy of the present invention is 10-100 Hz, including any sub-ranges therein, such as 10-70 Hz, 15-60 Hz, and 15-45 Hz; it also includes any specific point value frequency within this range, such as about 30 Hz, or about 45 Hz, or about 10 Hz, or about 65 Hz.

[0035] The vibration intensity range is 0.01-10g (where 1.0g = Earth's gravitational field = 9.8m / s / s), and any sub-ranges therein, such as 0.01-4.0g, 0.1-1.5g, 0.3-1g, and any specific point value intensity within this range, such as about 0.3g or about 1.0g.

[0036] The user can choose to use it 3-7 times a week, such as 3-5 times, 4-5 times, wherein the treatment time within 24 hours is preferably between 20-45 minutes, preferably 25-35 minutes, such as 30 minutes.

[0037] In some embodiments, the present invention can be implemented in a non-wearable manner such as a back cushion or a seat cushion.

[0038] Another embodiment is to configure the vibration device to be wearable and portable. In this case, the vibration device also includes a fixing mechanism for fixing the random vibration unit to the user's body. The fixing mechanism is configured to fix one or more random vibration units to at least one bone of the user.

[0039] In some embodiments, the fixing mechanism is configured to fix the random vibration unit in a lateral direction of the user's body.

[0040] In some embodiments of the present invention, the device's mounting mechanism is secured to an individual's shoulders to apply vibrations to the individual's back. In another embodiment, an additional mounting mechanism is secured to the individual's waist to provide additional support for the device while the device applies vibrations to the individual's back. In other embodiments, the mounting mechanism is secured only to the individual's waist or hips to apply vibrations at these locations. Thus, the location of vibration application can be adjusted to preferentially deliver vibrations to the spine, hips, or other locations.

[0041] In some embodiments, a wearable vibration device provides effective therapy by applying targeted oscillatory mechanical loads to the user's hips and spine.

[0042] In some embodiments, the device is worn on the sacrum and the vibrations are focused on the sacrum.

[0043] In some embodiments, the fixing mechanism is configured to fix one or more random vibration units to at least one skeletal part of the user, such as the hip, femur, limbs, head, knee, ankle, wrist, leg, arm, etc. This configuration is preferably a scaled-down version of the device disclosed in the embodiments of the present invention, so as to be worn around the spine, waist, or hips.

[0044] The wearable vibration device allows for the delivery of mechanical stimulation in the left-right, front-back, and / or top-bottom directions. This flexibility in the delivery system allows for better targeting of the hip and spine when treating osteoporosis and bone mineral loss. More specifically, in one variation, one or more random vibration units can be positioned against the user's body via one or more securing mechanisms, each configured to position the random vibration unit in a lateral direction relative to the individual's body, thereby applying the mechanical load laterally to the user.

[0045] In embodiments of user-selected custom modes, the vibration device further includes one or more motion information collectors for measuring the vibration acceleration generated by the one or more random vibration units. The motion information collectors may be accelerometers positioned near the area of ​​the user's body receiving the vibrations. The accelerometers are configured to detect the resulting vibration energy transmitted to the user's body area, providing data for customizing a personalized vibration plan.

[0046] In some embodiments, the vibrating device further comprises one or more pressure sensors for measuring and ensuring correct positioning and / or tensioning of the device to ensure that the user has securely worn the device before beginning treatment.

[0047] In some embodiments, the random vibration unit includes a vibration element configured to generate mechanical vibrations. In another embodiment, the vibration element includes a vibrating weight that moves in a random or deterministic manner. The vibration element generates vibrations at a frequency in the range of approximately 10-100 Hz, with a peak acceleration in the range of approximately 0.1-1.5 g, inducing strain in bone tissue in the range of approximately 1-500 microstrains.

[0048] In some embodiments, the random vibration unit includes a random vibration generator programmed so that the vibration includes random vibrations.

[0049] In order to ensure the efficiency of vibration transmission and the therapeutic effect, in some embodiments, the present invention also includes at least one columnar structure in contact with the user's body in the vibration device. The columnar structure is located on the contact unit of the random vibration unit and contacts the user's body to transmit the mechanical vibration to the user.

[0050] In some embodiments, the cross-section of the columnar structure can be any shape, including but not limited to circular, elliptical, square, rectangular, trapezoidal, polygonal, and rhombus. The most suitable shape is preferably rhombus. The columnar structure can be made of any material that ensures the desired vibration energy is transmitted to the user's body, such as a rigid or semi-rigid material with a density of 30-45 kg / m³, including but not limited to shape memory alloys, high-density polymer foams such as cross-linked polyethylene foam, silicone, TPU, etc.

[0051] In some embodiments, the height of the column is 1-50 mm, preferably 10-30 mm, and more preferably 10-20 mm; the columnar structure forms a tightly fitting shape on the contact surface with the user's body, preferably one or more curved surfaces that fit the shape of the user's sacrum, such as an arc, or a shape similar to an arc.

[0052] Another aspect of the present disclosure also includes a method for treating or preventing osteoporosis, comprising:

[0053] One or more random vibration units are fixed to the user's body, wherein the one or more random vibration units are configured to apply repetitive mechanical loads to the user's bone parts at a preset frequency and acceleration sufficient to produce a therapeutic effect on osteoporosis, and the mechanical load generated by the random vibration unit includes random vibrations.

[0054] In some embodiments, the random vibration unit applies a mechanical load to at least one bone site of the user's body, preferably in a lateral direction of the user's body.

[0055] The one or more random vibration units apply repetitive mechanical loads during the user's walking.

[0056] In some embodiments, the skeletal parts of the user are the hip, femur, and spine.

[0057] In some embodiments, the method further includes monitoring the frequency and acceleration via one or more accelerometers.

[0058] In some embodiments, the method further includes ensuring proper positioning and / or tensioning of the one or more vibrating elements using one or more pressure sensors.

[0059] Another aspect of the present invention includes a method for increasing bone mineral content, comprising:

[0060] One or more random vibration units are fixed to the body of an individual, wherein the one or more random vibration units are configured to apply repetitive mechanical loads to the individual's bone parts at a preset frequency and acceleration sufficient to produce a therapeutic effect on osteoporosis; the mechanical load generated by the random vibration unit includes random vibrations.

[0061] In some embodiments, the random vibration unit applies a mechanical load to at least one bone site of the user's body, preferably in a lateral direction of the user's body.

[0062] The one or more random vibration units apply repetitive mechanical loads during the user's walking.

[0063] In some embodiments, the skeletal parts of the user are the hip, femur, and spine.

[0064] In some embodiments, the method further includes monitoring frequency and acceleration via one or more accelerometers.

[0065] In some embodiments, the method further includes ensuring proper positioning and / or tensioning of the one or more vibrating elements using one or more pressure sensors.

[0066] Another aspect of the present invention also includes a method for promoting normal skeletal maturation, comprising:

[0067] One or more random vibration units are fixed to the body of an individual, wherein the one or more random vibration units are configured to apply repetitive mechanical loads to the individual's bone parts at a preset frequency and acceleration sufficient to produce a therapeutic effect on osteoporosis; the mechanical load generated by the random vibration unit includes random vibrations.

[0068] In some embodiments, the random vibration unit applies a mechanical load to at least one bone site of the user's body, preferably in a lateral direction of the user's body.

[0069] The one or more random vibration units apply repetitive mechanical loads during the user's walking.

[0070] In some embodiments, the skeletal parts of the user are the hip, femur, and spine.

[0071] In some embodiments, the method further includes monitoring frequency and acceleration via one or more accelerometers.

[0072] In some embodiments, the method further includes ensuring proper positioning and / or tensioning of the one or more vibrating elements using one or more pressure sensors. Beneficial effects

[0073] The present invention has the following effects:

[0074] (1) The present invention includes mechanical stimulation of random vibration, which is closer to the vibration mode in life, has a more natural vibration mode, a wider and more coordinated distribution of vibration frequency / vibration intensity, and has a good bionic effect.

[0075] (2) Compared with the vibration mode of fixed frequency or regular frequency variation, the vibration mode of the present invention including random vibration can better stimulate the growth of bone cells in the body. The sensitivity of bone cells to vibration stimulation is not easily blunted or lost, and the density of trabeculae and bone mineral content can be better increased.

[0076] (3) The random vibration mode of the present invention includes a wider spectrum and more diverse vibration frequency / vibration intensity modes, so it has a wider audience and can benefit people with different bone conditions, different ages, and genders.

[0077] (4) The present invention includes a random vibration mode, which can achieve the same stimulation to the bones as traditional long-term exercise in a short period of time, so that the user can achieve the same bone recovery and bone growth benefits as exercise even when it is inconvenient for exercise.

[0078] These and other features, objects and advantages of the present invention will become apparent to those skilled in the art after reading the following, the details of which are more fully described below. BRIEF DESCRIPTION OF THE DRAWINGS

[0079] FIG1 shows an axonometric view of a vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention.

[0080] FIG2 shows a front view of the internal structure of a random vibration unit of a vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

[0081] FIG3 shows a flow chart of generating and controlling random vibrations by a random vibration unit of a vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

[0082] FIG4 shows a flow chart of the operation of each vibration mode of the vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

[0083] FIG5 shows a diagram of a locally amplified signal of a completely random vibration mode of a vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

[0084] FIG6 shows a diagram of all signals of a completely random vibration mode of a vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

[0085] FIG7 shows a diagram of a locally amplified signal of a vibration mode simulated by slow walking of a vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention.

[0086] FIG8 shows a diagram of all signals of a simulated slow walking vibration mode of a vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention.

[0087] FIG9 shows a diagram of a locally amplified signal of a vibration mode simulated sprinting of a vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention.

[0088] FIG10 shows a diagram of all signals of a simulated sprint vibration mode of a vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention.

[0089] FIG11 shows a diagram of a locally amplified signal of a vibration mode simulating a skipping rope of a vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention.

[0090] FIG12 shows a diagram of all signals of a vibration mode simulating rope skipping of a vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention.

[0091] FIG13 shows a random vibration signal generation mechanism of a vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

[0092] FIG14 is a schematic diagram showing the working process of the internal components of the random vibration unit of the vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

[0093] FIG15 is a schematic diagram showing the position of a pressure sensor in a vibration device according to an embodiment of the present invention.

[0094] FIG16 shows a vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention, which includes three vibration units.

[0095] FIG17 shows a schematic diagram of a honeycomb cross-section column of a vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention.

[0096] FIG18 shows a side view of the honeycomb cross-section cylinder of the vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention as shown in FIG17 .

[0097] FIG. 19 is a block diagram of a data processing system that may be used with the vibration device of any embodiment of the present invention.

[0098] FIG20 shows a schematic diagram of the three-dimensional structure of a vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention. DETAILED DESCRIPTION

[0099] Figure 1 shows an axonometric view of a vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention. As shown in Figure 1, this embodiment is designed to be worn around the waist so that vibration energy is applied to the user's hip / spinal region. In some embodiments, the device is worn so that the vibration energy is concentrated on the sacrum. A fixing mechanism 1 can secure the wearable vibration device to the body, such as the waist. The contact unit 2 is the component that directly contacts the user's body. It is part of the random vibration unit 3 and exists as an integral component with the random vibration unit 3. In some embodiments, the contact unit 2 can also be a separate unit, directly contacting the random vibration unit 3, or connected to the random vibration unit 3 via the fixing mechanism 1 to transmit vibration. The random vibration unit 3 may include a vibration element 301, a random vibration generator 908, a processor 901, a battery 302, a battery management module 902, a buzzer / alarm 903, a charging indicator light 906, a status indicator light 907, a motor 304, an encoder 904, a rotating shaft 307, and other components and / or electronic devices. The contact unit 2 and the vibration unit 3 are connected via a fixing mechanism 1. The contact unit 2 and the vibration unit 3 can be fixed on the fixing mechanism 1 or moved on the fixing mechanism 1. When moving, the contact unit 2 and the vibration unit 3 always maintain a constant relative position.

[0100] Figure 2 shows a front view of the internal structure of the random vibration unit of a vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention. As shown in Figure 2, PCB 305 controls the overall operation of the device. Battery 302 powers the device, with PCB 305 controlling its charging and discharging. A random vibration generator 908 is connected to the PCB and can be directly integrated onto the PCB or externally as a separate unit. It receives vibration generation commands from processor 901 and drives motor 304 to vibrate accordingly. Motor 304 is centrally located and rotates under the drive of the random vibration generator. Torque is transmitted to vibration element 301 via shaft 307, generating vibration acceleration. Housing 303 protects the internal components of the device and prevents dust. Shaft 307 and vibration element 301 are both located in the center of the random vibration unit.

[0101] The vibrating element 301 can be configured to apply a repetitive mechanical load by any method known in the art. In some embodiments, the vibrating element 301 may include an oscillating element powered by a power source. For example, an electromagnetic weight can be attached to a spring that is mounted inside the vibrating element 301 for oscillating motion and is alternately attracted and repelled by a surrounding frame made of a black material, i.e., an oscillating mass that moves in a periodic motion. In some embodiments, the vibrating element can be an ultrasonic transducer that induces vibrations of a desired amplitude. In some embodiments, the vibrating element is a crank slider mechanism. In other embodiments, the vibrating element 301 is an eccentric weight that generates vibrations when it rotates.

[0102] In some embodiments, the vibration element 301 can generate vibrations using a powered eccentric rotating mass motor controlled by pulse width modulation (PWM). The duty cycle of the motor PWM can be varied to tune the rotation frequency, which also changes the amplitude (the motor frequency and amplitude are approximately linearly proportional within the motor frequency range of 15 Hz-60 Hz). The motor can be connected to and oriented within the assembly to transmit the vibrations to the user.

[0103] Figure 3 shows a flow chart illustrating the generation and control of random vibrations by the random vibration unit of a vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention. As shown in Figure 3 , the device is first turned on and enters the pre-test phase, indicated by 601. The PCB 305 is powered on and the power-on test program is executed, indicated by 602. Components such as the motor 304 and battery 302 are checked for abnormalities, indicated by 603. If an abnormality is detected, the abnormality indicator light illuminates, prompting the user to perform maintenance, indicated by 610. If no abnormality is detected, the user sets the treatment mode and treatment time, indicated by 608. Once the settings are complete, the processor 901 receives the relevant instructions and sends a vibration generation signal to the random vibration generator 908. Simultaneously, the processor 901 starts timing, indicated by 607. Upon receiving the vibration generation signal, the random vibration generator 908 generates a voltage waveform based on relevant parameters to drive the motor 304 to rotate, thereby driving the vibration element 301 to generate vibration acceleration. The processor 901 then monitors in real time whether the treatment time has expired, indicated by 609. After the timer ends, the treatment process ends, as indicated by 611.

[0104] The random vibration therapy mode can be personalized for people with different needs and completed by the random vibration unit 3. The modes that can be set as needed are: completely random mode, motion simulation mode, and custom mode. The completely random mode imitates the common disordered random vibration signals in the environment. The user can adjust the frequency range, amplitude, power spectrum density and other parameters of the random vibration, or directly use the vibration mode predetermined by the equipment. The motion simulation mode simulates the vibrations generated by the bones of the human body during exercise and training. The simulated movements include but are not limited to: slow walking, brisk walking, running, skipping rope, climbing, cycling, etc. The custom mode allows users to freely choose the simulated movement. In the embodiment of the present invention, the duration of the random vibration is preferably 25-45 minutes, preferably 30 minutes.

[0105] Figure 4 shows a flow chart of the various vibration modes of the vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention. As shown in Figure 4 , first, the user selects a vibration treatment mode, which is represented by box 701 .

[0106] In some embodiments, the user can select a completely random mode, represented by box 702, which simulates the random vibration generated by the user during normal exercise, that is, the completely random vibration generated by exercise. The vibration device will generate a completely random signal according to preset parameters, represented by box 705. The completely random signal of the present invention can be obtained by the properties and generation methods of random signals disclosed in the prior art. By specifying a series of parameters of the random signal, including amplitude, frequency, power spectrum density, distribution of the random signal, etc., the generated signal is filtered through a bandpass filter to ensure that the vibration frequency and intensity are within the range suitable for vibration stimulation of bone growth (the present invention is frequency 10-100Hz, intensity 0.01-1.5g), thereby obtaining a specific completely random signal scheme, represented by box 708. One embodiment of the present invention uses random vibration amplitude of 0.8g and frequency in the range of 15-60Hz to generate random vibration for 30 minutes. Its local vibration signal pattern is shown in Figure 5, and the entire vibration signal pattern is shown in Figure 6 (the ordinate is intensity g, the abscissa is time, 0.2s is the interval, multiplied by 104).

[0107] In some embodiments, the user can select a motion simulation mode, represented by block 703 in FIG. 4 , and can choose different types of exercise, such as brisk walking, jogging, rope skipping, and mountain climbing. This simulates the composite vibration generated during normal user exercise, a superposition of periodic and completely random vibrations, with approximately periodic properties. The present invention uses typical amplitudes and accelerations associated with such exercises: a harmonic vibration frequency of 2 rad / s and an acceleration intensity of 0.6g for slow walking; a harmonic vibration frequency of 3.3 rad / s and an acceleration intensity of 0.8g for jogging; and a harmonic vibration frequency of 1.3 rad / s and an acceleration intensity of 1.2g for rope skipping. The device of the present invention generates corresponding periodic signals based on the vibration characteristics of different types of exercise, represented by block 706 in FIG. This embodiment utilizes conventional methods for generating periodic signals to obtain vibration signals for simulated exercise. The generated periodic signal is superimposed with the random signal generated using the previously described completely random vibration mode, represented by block 709 in FIG. 4 , to obtain composite vibration signals simulating various types of exercise.

[0108] The vibration intensity in this embodiment varies in a pulsating manner between 0.2 and 1.5 g to simulate periodic motion. The harmonic signal of the periodic vibration is then combined with the random signal of the random vibration to form a composite signal. This signal is then filtered through a bandpass filter to ensure a frequency range of 15-60 Hz, generating vibrations that simulate different types of motion. The mechanical stimulation generated within this range benefits human bone growth.

[0109] For example, in this embodiment, the vibration signal during slow walking is simulated, and the harmonic vibration frequency during slow walking is specified to be 2 rad / s and the vibration acceleration amplitude is 0.6 g. The generated harmonic signal is: H = 0.6sin(2t+φ)

[0110] The random signal uses a Gaussian white noise signal with an amplitude of 0.4g, a frequency range of 15-60Hz, a power spectrum density of a straight line, and a Gaussian distribution. The probability density function of the Gaussian distribution is known to be:

[0111] In this example, a standard Gaussian distribution is used, that is, μ = 0, σ = 1.

[0112] By superimposing the harmonic signal with the random signal, a simulated slow-walking signal is obtained. Other types of motion signals can also be generated by the above method to generate vibration signal pattern diagrams of different motion signals (Figures 7, 9, and 11 are local vibration signal diagrams; Figures 8, 10, and 12 are all vibration signal patterns).

[0113] In some embodiments, the user can also select a custom mode, as indicated by block 704 in FIG4 . This custom mode is suitable for those who want to more accurately simulate the vibrations generated by their own exercise. This mode measures each user's actual exercise conditions and configures a random vibration pattern tailored to each user's situation. This allows for personalized random vibration treatment, resulting in more precise treatment and better bone growth stimulation.

[0114] In equipment including a custom mode, the equipment further includes one or more motion information collectors 5, which are located inside the random vibration unit 3. One specific embodiment uses an acceleration sensor 910 to measure the vibration acceleration of the wearable vibration device. The vibration acceleration sensor can use an acceleration sensor of a type known in the prior art, including but not limited to acceleration sensors that obtain data by measuring the electrical quantity of a piezoresistor, acceleration sensors that obtain data by measuring changes in capacitance, and acceleration sensors that use piezoelectric ceramics to obtain acceleration data by measuring voltage changes through the inverse piezoelectric effect.

[0115] When using the custom mode, the user wears the equipment of the present invention to perform normal exercise. The motion information collector will detect the user's motion information, such as acceleration, when exercising while wearing the wearable vibration device in real time, and measure for 30 minutes. The motion information will be transmitted to the processor 901 for calculation. The processor performs filtering analysis, feature extraction and other processing steps on the acceleration data, extracts the information of vibration generated during exercise, and sends the vibration generation signal to the random vibration generator 908. The relevant parameters of the simulated motion are adjusted according to the custom motion situation, thereby achieving more accurate vibration therapy suitable for each user's own situation. After the parameters are saved, the user can directly use the saved vibration parameters for treatment.

[0116] When the flow process on the right side of Fig. 4 has shown the adoption of custom mode, the motion information collector measures the vibration acceleration signal analog quantity of the user when exercising, and sets the corresponding vibration parameter according to the measurement result, represented by frame 707, after the vibration parameter setting is completed, it can be saved in the processor so that it can be used next time.After measuring, the user can reach the effect of utilizing this device to simulate any movement by calling out the motion pattern preserved in the processor, represented by frame 710. After generating the signal of required vibration acceleration, processor 901 receives relevant instructions, and vibration generation signal is sent to random vibration generator 908, then signal is converted to voltage signal and is applied on motor 304, represented by frame 711, and can realize the negative feedback regulation control to motor 304 by motor encoder, make the vibration acceleration that motor 304 produces can just meet the signal of the required vibration acceleration generated.Finally, motor 304 starts to move, represented by frame 712.

[0117] The three random vibration modes described above are merely three typical random vibration modes for the embodiments of the present invention. Without limitation, the present invention may also employ random vibration schemes derived from existing random vibration theories. As long as the vibration frequency and intensity fall within the appropriate range for stimulating bone growth, such schemes are applicable to the random vibration bone growth stimulation of the present invention.

[0118] Figure 13 shows the random vibration signal generation mechanism of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention. As shown in Figure 13, first, the processor 901 receives an instruction to generate a vibration signal, represented by box 801. If the preset mode is used to specify its initial vibration parameters (completely random mode or simulated motion mode), represented by box 804, the initial parameters of the vibration signal in the memory can be directly called, represented by box 805. If custom parameters are used, the motion information collector must first collect information, represented by box 802. After the collection is completed, the collected motion information is imported into the processor 901, and the corresponding vibration parameters that meet this vibration signal are extracted, such as vibration amplitude, vibration frequency, phase, etc., represented by box 803. After the extraction is completed, the vibration parameters are saved for next use, represented by box 806.

[0119] After obtaining the vibration parameters, a verification process is first required to confirm that the vibration data is within the permissible range for the human body, as represented by box 805. Subsequently, the obtained vibration parameters are transmitted to the random vibration generator 908, as represented by box 807. The random vibration generator 908 generates a random signal and / or a harmonic signal based on the relevant parameters, as represented by box 808. The obtained signal is first superimposed (this step is skipped for a completely random mode) and then filtered, as represented by box 809. The random vibration generator then converts it into a voltage signal and applies it to the motor 304, as represented by box 811. The motor encoder 904 detects its speed and controls its precise operation through inverse feedback regulation, as represented by box 810. Finally, a vibration signal is generated, as represented by box 812. The frequency of the random vibration energy in the embodiment of the present invention is approximately 10-100 Hz per second, and the intensity range of the random vibration is 0.01-1.5g.

[0120] Figure 14 shows a schematic diagram of the internal components of the random vibration unit of a vibration device for treating osteoporosis and increasing bone strength and density according to one embodiment of the present invention. As shown in Figure 14 , the processor 901, battery management module 902, buzzer / alarm 903, and random vibration generator 908 are all located on the PCB 305. The buzzer / alarm 903 is used for alarms, and the battery management module 902 is responsible for managing battery charging and discharging. The random vibration generator 908 can be located on the PCB 305 or independently of the PCB and is used to generate a vibration signal to drive the motor. The PCB 305, along with other components such as the battery 302, motor 304, motor encoder 904, and motion information collector (an accelerometer in this embodiment) 910, are all located within the housing 303. The battery 302 provides power, the motor 304 generates torque, and the encoder 904 provides feedback control of the motor's rotation. The outside of the housing 303 has components such as a charging port 909 , a power switch 905 , a charging indicator light 906 , a status indicator light 907 , and a pressure sensor 4 .

[0121] In addition to the aforementioned motion information collector, the wearable vibration device of the present invention may also include one or more other types of sensors. In some practical examples, the wearable vibration device may include one or more pressure sensors. The pressure sensors 4 are distributed on the surface of the vibration contact unit 2. This pressure sensor can be used to measure the user's wearing condition, and the pressure can be used to determine whether there are problems such as incorrect wearing position, too loose or too tight wearing, etc. When the above problems are detected, the signal is transmitted to the processor 901, and the processor can indicate the adjustment method to the user through the display device, prompting the user how to adjust the device, such as adjusting the position of the device, tightening or loosening the device. The adjustment method can be automatically adjusted by the processor controlling the mechanical device, or manually adjusted by the user.

[0122] Figure 15 shows a schematic diagram of the location of pressure sensors in a vibration device according to one embodiment of the present invention. As shown in Figure 15, a fixing mechanism 1 secures the wearable vibration device to the waist. The contact unit 2 can be directly attached to the user's waist. Pressure sensors 4 are located on the surface of the contact unit 2 and transmit pressure data to a processor via wired or wireless signals.

[0123] One or more pressure sensors in the above embodiments can be placed anywhere on the wearable vibration device, including straps, bands, fixing mechanisms, motors, spacers, containers, etc. In some embodiments, the sensor can be physically separated from the device but in wired or wireless communication with the device's processor. In addition, one or more alarms can be included in the wearable vibration device to alert the user to adjust the fit. Various types of alarms can be used, including audible, visual, such as flashing lights, tactile, such as pulses from a vibration motor, etc. The alarm can sound for a set period of time, or until the fit is improved, or both. Additionally or alternatively, the fixing mechanism of the wearable vibration device can self-adjust based on feedback from the fit sensor. This can be achieved through a motor, thermal mechanism, mechanical mechanism, electrical mechanism, etc.

[0124] In some embodiments, the wearable vibration device may include both a pressure sensor 4 and a motion information collector 5. The pressure sensor is in contact with the user's body. The pressure sensor 4 detects the pressure caused by the motor's vibrations and the overall fit of the wearable vibration device against the user's body before, during, or after the motor is activated. An example of the motion information collector 5 is an accelerometer 910, which is used to collect acceleration during movement and generate an acceleration analog value to facilitate the algorithm system in the processor to calculate the required vibration parameters.

[0125] In some embodiments, the fixing mechanism 1 fixes the vibration device at the waist. In this case, the vibration device can be fixed at positions such as the sacrum and hip bones where vibrations are easily transmitted. In other embodiments, the vibration device is fixed to other areas of the body to exert preventive or therapeutic effects. For example, a wearable vibration device can be designed to be worn on the neck, back, limbs, head, feet, etc. These embodiments include but are not limited to: vibrations can be transmitted through devices such as wristbands or elbow rings, knee pads, shoes or socks, or tied or otherwise fixed to the wrists, elbows, knees, feet or other parts of the lower limbs. Vibration stimulation transmitted to the wrists, elbows, feet or lower limbs can also help treat osteoporosis or other diseases.

[0126] The fixing mechanism 1 can be of any shape and any suitable material. For example, the fixing mechanism 1 can be made of a known elastic material, such as but not limited to cloth, woven or non-woven material, natural or synthetic rubber, silicone rubber, polyurethane, nylon or polyester, with one or more housings for containing the random vibration unit 3.

[0127] The fixing mechanism 1 can be in the form of a vest and can include one or more sleeves or shoulder straps for the upper limbs of the subject. The fixing mechanism 1 can also include, but is not limited to, shoe-type, wrist-guard-type, knee-guard-type, ankle-guard-type, belt-type, and shorts-type. The fixing mechanism can fix the random vibration unit 3 to the torso of an individual in any way, such as but not limited to Velcro, hooks, buckles, buttons, zippers, laces (such as shoelaces), adhesives, etc. The random vibration unit 3 does not have to be contained in a shell and can be connected to the fixing mechanism 1 in any other way, such as but not limited to by bonding, embedding, etc. The fixing mechanism 1 can have any length, width, and thickness.

[0128] Embodiments of the vibration device of the present invention can be used for the prevention, treatment, and rehabilitation of osteoporosis, femoral head necrosis, osteopenia, bone dysplasia, and various types of fractures. Furthermore, the device can be used to treat sacroiliac (SI) syndrome, SI arthropathy, SI instability, SI obstruction, myalgia and tendinopathy in the pelvic region, pelvic ring instability, and, in the case of structural disorder after lumbar fusion, to prevent recurrent SI obstruction and myopathy (rectus abdominis, piriformis), joint rupture and laxity, back pain, cartilage strengthening, and other conditions.

[0129] The vibration device of the present invention includes at least one random vibration unit 3. In some embodiments, multiple random vibration units can be selected according to the situation. One representative embodiment is shown in Figure 16, which shows a vibration device for treating osteoporosis, increasing bone strength and bone density according to an embodiment of the present invention. The vibration device includes three vibration units, and the positions of the three random vibration units can be fixed on the fixing mechanism 1 or moved, so that the three random vibration units can be located at any position of the body, such as one random vibration unit is located at the sacrum position, and the other two random vibration units are located at the hip bone positions on both sides of the waist, especially the hip crest position. The three random vibration units can also be arranged at the sacrum position in a direction parallel or perpendicular to the spine, or combined with the placement of other bones.

[0130] The vibration energy of different random vibration units can be configured to combine and coordinate the same or different vibration modes and schemes. For example, in some embodiments, different random vibration units can all select a completely random vibration mode, or a combination of two different vibration modes, such as a combination of a custom mode and a simulated motion mode, or a combination of a custom mode and a completely random vibration mode.

[0131] Different random vibration units can be configured to align in different directions, more than one direction, alternating directions, or different directions simultaneously; or the vibration energy of different random vibration units can vary over time, increase or decrease in amplitude, increase or decrease in frequency, change direction, cycle through programs, turn on and off, and so on. The stimulating vibrations can also include different waveforms, such as square, triangular, sawtooth, or sinusoidal waveforms. These different waveforms can introduce harmonics of the fundamental frequency and provide enhanced or additional benefits. Multiple frequencies can also be superimposed within a random vibration unit. Multiple vibration devices can be worn. Multiple vibration units can be used to partially or completely cancel, increase, or vary the vibration energy applied to the user. Vibration energy can be delivered transcutaneously to an implanted metal plate. For example, a vibration device can 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 can be used periodically, perhaps once daily, weekly, or monthly, to reduce bone necrosis.

[0132] In some embodiments, one or more columns perpendicular to the contact surface may be provided on the contact unit 2. FIG17 shows different schematic views of a honeycomb cross-section column of a vibration device for treating osteoporosis, increasing bone strength and bone density according to an embodiment of the present invention. FIG18 shows a side view of a honeycomb cross-section column of a vibration device for treating osteoporosis, increasing bone strength and bone density according to an embodiment of the present invention as shown in FIG17 . As shown in FIG17 and FIG18 , the height of these columns can be adjusted according to the specific conditions of the contact surface with the human body to form an ergonomic contact unit 2 that better fits the contact surface with the human body, thereby increasing the comfort of the human body and increasing the closeness of fit with the human body, thereby ensuring and improving the efficiency of kinetic energy transfer. The column may occupy a partial area of ​​the contact surface, or it may completely occupy the entire contact surface. The column may be gradually narrowed or not.

[0133] In some embodiments, the cross section of the column can be a honeycomb equilateral hexagon. In other embodiments, the cross section of the column can also be an irregular hexagon, circle, ellipse, square, rectangle, trapezoid, polygon, rhombus, or any other shape.

[0134] In some embodiments, the column is rigid or semi-rigid. Shape memory alloys can be used to adapt the column to the user's waist curve. In other embodiments, the column can be freely retractable along the axis, automatically moving to the appropriate position when worn to accommodate different body shapes and improve fit. For example, a liquid can be used to propel the column into position, and a valve can automatically close after adjustment to lock the column position.

[0135] The column can be made of any material capable of effectively transmitting vibration energy, including but not limited to high-density polymer foams, such as cross-linked polyethylene foam, silicone, TPU, and other materials. The column's height is 1-30 mm, preferably 10-20 mm. Its ergonomic shape comprises one or more curved surfaces, such as an arc or a shape similar to an arc, that conform to the shape of the user's sacrum.

[0136] FIG19 is a block diagram of a data processing system that can be used with the vibration device of any embodiment of the present invention. For example, the system can be used as part of a processor. Note that while FIG19 illustrates various components of a computer system, it is not intended to represent any particular architecture or manner of interconnecting the components, as such details are not germane to the present invention. It will also be appreciated that network computers, handheld computers, mobile devices, tablet computers, cell phones, and other data processing systems having fewer or potentially more components can also be used with the present invention.

[0137] As shown in Figure 19, a computer system as a form of data processing system includes one or more processors 901 coupled to ROM 1001, volatile RAM 1002, and non-volatile memory 1003. A bus 1004 interconnects these various components and also interconnects the processor 901, ROM 1001, volatile RAM 1002, and non-volatile memory 1003 to an input / output (I / O) device 1005 and, through the input / output (I / O) device 1005, to a control unit 1006, which may be a mouse, keyboard, modem, network interface, printer, or other devices known in the art, a display unit 1007, a vibration unit 1008, and a communication unit 1009. The control unit 1006 may be a mouse, keyboard, modem, network interface, printer, or other devices known in the art.

[0138] Volatile RAM 1002 is typically implemented as dynamic RAM (DRAM), which continuously requires power to refresh or maintain the data in the memory. Non-volatile memory 1003 is typically a magnetic hard drive, a magnetic optical drive, an optical drive, or a DVD / RAM or other type of memory system that retains data even after power is removed from the system. Typically, non-volatile memory 1003 will also be random access memory, however this is not required.

[0139] The non-volatile memory 1003 can be a local device directly coupled to the rest of the components in the data processing system, or non-volatile memory 1003 can be utilized remotely from the system; such as a network storage device coupled to the data processing system via a network interface (such as a modem or Ethernet interface). The bus can include one or more buses connected to each other through various bridges, controllers, and / or adapters, as are known in the art. In one embodiment, the I / O control unit 1006 can also include a USB adapter for controlling USB (Universal Serial Bus) peripheral devices. Alternatively, the control unit 1006 can 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 can include Wi-Fi, Bluetooth, ZigBee, near field, cellular, and other protocols.

[0140] Figure 20 shows a schematic diagram of the three-dimensional structure of a vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention. As shown in Figure 20, it shows a battery 302, three parts of the housing 303 (respectively, the contact unit 2 that contacts the user's body, the rear portion 911 of the housing that directly contacts the contact unit 2, and the front portion of the housing with the liquid crystal display 308), a printed circuit board assembly (PCB) 305, screws 912, a motor 304, a rotating shaft 307, an eccentric shaft 309, a processor 901, and a random vibration generator 908. The housing may include a housing made of ABS (acrylonitrile butadiene styrene plastic). The plate may be a 0.1" aluminum plate.

[0141] The vibration equipment is mounted to the fixing unit via the contact unit 2. A strip of neoprene which is part of the fixing unit is sandwiched between the contact unit 2 and the front of the housing 303 using four screws 912.

[0142] The vibration device of the present invention can also be provided in the form of a seat cushion or pad. The contact unit 2 itself or a seat pan connected to the random vibration unit 3 and vibrating, optionally includes a padding covering the seat pan, and a layer comprising foam or other padding. The seat pan can be metal, polymer, or any other suitable material. Preferably, the pad is rigid or semi-rigid. The shape of the pad can support the hip bones to maximize the transmission of vibration energy from the pad to the bones. The processor and random vibration generator can be integrated into the pad, or can be a separate device that controls the pad wirelessly or via a wired connection. The user places the seat cushion / covering on a chair or other surface and sits on top of the seat cushion so that the hip area, including the bony prominences forming the ischium, is in contact or near contact with the pad. A padded covering can be provided between the pad and the user. Vibration energy is transferred from the pad to the ischium and bones, typically to the lower back and hip area. The vibration energy can be horizontal, vertical, or both. In this embodiment, the user's weight helps ensure that the device is properly "fitted" to the body.

[0143] The vibration device can also be in the form of a backrest pad that rests against the back of the chair, with the plate area of ​​the device in contact with the hip bone, sacrum, or, for example, ilium. In this embodiment, a strap can be included to increase the proximity of the vibration device to the hip bone area.

[0144] The vibration device may also be in the form of a weighted thigh pad with the vibration plate area adjacent to the iliac crest area of ​​the hip bone.

[0145] Vibration therapy can also be performed at forces and frequencies that treat ailments such as pain, muscle paralysis, chills, and digestive disorders.

[0146] However, it should be understood 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. 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 use 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, acoustic or other forms of propagated signals, such as carrier waves, infrared signals, digital signals)) to store code and data and transmit code and data (internally and / or over a network with other electronic devices).

[0147] The processes or methods depicted in the preceding figures may be performed by processing logic comprising 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. Furthermore, some operations may be performed in parallel rather than sequentially.

[0148] Any feature of any embodiment disclosed herein may be used with any other embodiment.

[0149] Effect Example 1: Therapeutic Effect of Random Bionic Vibration Device on Osteoporosis in New Zealand Rabbits

[0150] Experimental Materials and Methods

[0151] 1. Sixty female New Zealand purebred white rabbits (Changsha Tianqin Biotechnology Co., Ltd.), 6 months old and weighing 2.8±0.25 kg, were selected as model animals.

[0152] 2. Ovariectomy was performed. The ovariectomy procedure was as follows: Anesthesia was achieved by intraperitoneal injection of 10% chloral hydrate (Sigma, USA) at 0.35g / kg. The rabbits were placed in a supine position with their abdomen facing upwards. The surgical area was shaved, disinfected with iodine, and both ovaries were surgically removed. Three days before surgery, lumbar spine bone density (BMD) was measured using an X-ray absorptiometry (GE, USA). Four months after surgery, BMD at the lumbar spine and proximal femur was measured again using an X-ray absorptiometry to confirm successful establishment of the osteoporosis animal model. Successful modeling was determined when the mean BMD of all animals was less than the pre-castration mean minus 2.0SD.

[0153] 3. After confirming successful modeling, 60 osteoporotic rabbits were randomly divided into six groups: a blank control group (Group A, no vibration stimulation), a positive control group (Group B, 30Hz regular sinusoidal vibration), a completely random vibration group (Group C), a simulated jogging group (Group D), a simulated sprint group (Group E), and a simulated rope skipping group (Group F). Groups CF corresponded to the vibration patterns shown in Figures 8, 10, and 12, respectively. Animals in groups BF were secured in a rabbit stand and received 33-minute vibration therapy at the lumbar spine once daily for three months. Each group consisted of 10 animals. All animals were fed a fixed diet (200g / day) and had free access to water. The animals were housed at a temperature of 20-25°C and a relative humidity of 40%-70%.

[0154] 4. After 3 months of vibration therapy, the control group and each experimental group were killed by air embolization of the marginal ear vein. The distal end of the right femur was separated, and 10 specimens from each group were placed in a Micro-CT (GE-LSPmicro-CT, GE Company, USA) sample cup. The specimens were scanned under the same conditions (44 mL tube, 21 μm, 150 mins, threshold: 1044). BMD and bone mineral content (BMC) were measured, and trabecular stereometric indicators such as trabecular number, thickness, connection density, and bone volume ratio were analyzed.

[0155] 5. Statistical analysis. Data are expressed as mean ± standard deviation. SPSS 11.0 statistical software was used for variance analysis and LSD-t test.

[0156] 1. Results of establishing an osteoporosis animal model

[0157] The mean BMD values ​​of all animals before and after castration were compared, and the results are shown in Table 1. The results in Table 1 show that the BMD of the lumbar spine and proximal femur of rabbits decreased significantly after castration, and the difference from the BMD before castration was statistically significant (P < 0.05), indicating that the model was successful.

[0158] Table 1 BMD results of lumbar spine and proximal femur of New Zealand rabbits before and after castration (mg / cm 2 . )

[0159] 2. BMD and BMC test results of each group after random vibration treatment

[0160] Table 2 reports the BMD and BMC results of the distal femur in the control group and each experimental group. The statistical results show that, compared with the control group, the mean BMD and BMC values ​​of the distal femur in Group BF were significantly higher than those in Group A, demonstrating statistically significant differences. There were no statistically significant differences in BMD between Groups B and CF, or between any two CF groups. However, the random vibration group showed higher BMD values ​​than Group B. While there were no statistically significant differences between the CF groups themselves, there was a statistically significant difference between the CF groups and Group B. This demonstrates that the random vibration mode of the present invention can achieve bone density increases comparable to those achieved with traditional periodic frequency modulation, and can even more effectively increase bone mineral content in subjects with osteoporosis.

[0161] Table 2 Results of distal femur BMD and BMC

[0162] The distal femoral trabecular indices of each group of animals were measured, and the results obtained are shown in Table 3. The results in Table 3 show that the differences in various test indicators between Group A and Group BF were statistically significant. The differences in the BV / TV and trabecular connection density test results between Groups B and CF were statistically significant. The TB.N, Tb.Sp and Tb.Th test results of Group CF were all higher than those of Group B. In some random vibration groups, the differences in TB.N and Tb.Sp compared with Group B were also statistically significant. Trabecular bone is the most active component of bone metabolism because it is close to the bone marrow space, but trabecular bone is also extremely susceptible to local or systemic disturbance factors, leading to bone metabolism imbalance. Compared with the traditional method, the random vibration method of the present invention can better promote trabecular growth and inhibit bone imbalance.

[0163] Table 3 Results of stereometric indices of distal femoral trabeculae

[0164] Effect Example 2: Therapeutic Effect of Random Bionic Vibration Device on Osteoporosis in Menopausal Women

[0165] Through volunteer recruitment, a similar pilot study was conducted, selecting 60 postmenopausal and early postmenopausal women who met the criteria for osteoporosis. The women were randomly divided into three groups: two random bionic vibration groups, which received vibration therapy using the random bionic vibration device shown in Figure 20 of the present invention, and one control group. The random bionic vibration group applied random vibrations within a frequency range of 30 to 50 Hz to the human body to observe the clinical effect of vibration in combating bone loss. The subjects were divided into vibration groups A1 and A2 and control group B. Group A1 used the completely random vibration pattern shown in Figures 5-6, and Group A2 used the simulated rope skipping pattern shown in Figures 11-12.

[0166] According to the expected treatment plan, a course of treatment is 6 months, with 5 vibration treatments per week, each treatment lasting 30 minutes.

[0167] Heart rate and blood pressure monitors were provided to subjects in groups A1 and A2. Blood pressure and heart rate were measured and recorded before and after each treatment. Subjects in each group were instructed to maintain their existing lifestyle habits. Bone density measurements were performed on the entire body, at lumbar vertebrae 2-4, and at the femoral neck before and after treatment.

[0168] Statistical analysis was performed using SAS (version 9.2). Paired-sample t-tests were used to compare bone mineral density in the vibration group before and after intervention and in the control group before and after follow-up. Two independent-sample t-tests were used to compare changes in bone mineral density before and after vibration and follow-up in the vibration and control groups.

[0169] The examination equipment is a DEXA bone density detector (bone densitometer).

[0170] The study is still ongoing. In the preliminary bone density spot check test over 3 months, it was observed that the bone density of the subjects in the vibration group decreased at a slower rate than that of the subjects in the control group. This confirms that the random bionic vibration device of the present invention is effective in treating osteoporosis.

Claims

1. A vibration device for treating osteoporosis and increasing bone strength and bone density, characterized in that: The device comprises at least one random vibration unit, wherein the random vibration unit is configured to generate mechanical vibration, wherein the mechanical vibration includes random vibration, and wherein the mechanical vibration is configured to apply a mechanical load to a user at a preset frequency and acceleration.

2. The vibration device for treating osteoporosis and increasing bone strength and bone density according to claim 1, characterized in that: The mechanical vibration is a random vibration, and the random vibration is selected from a stable random vibration or an unsteady random vibration; preferably, the random vibration is selected from a stable random vibration, and more preferably, the random vibration is a narrow-band random vibration or a wide-band random vibration.

3. The vibration device for treating osteoporosis and increasing bone strength and bone density according to claim 1 or 2, characterized in that: The mechanical vibration simulates the vibration generated by human body movement, and the mechanical vibration is a combination of random vibration and deterministic vibration; the random vibration is selected from one of stable random vibration and unsteady random vibration; preferably, the random vibration is selected from stable random vibration, and more preferably, the random vibration is narrow-band random vibration or wide-band random vibration; the deterministic vibration is selected from periodic vibration, such as sinusoidal vibration.

4. The vibration device for treating osteoporosis and increasing bone strength and bone density according to claim 3, characterized in that: The vibration frequency range generated by the random vibration unit is about 10-100 Hz, preferably 10-70 Hz, and more preferably 15-60 Hz; the peak acceleration range generated by the random vibration unit is about 0.01-1.5 g, preferably 0.3-1 g; the mechanical vibration includes a treatment time of between 20-45 minutes within 24 hours, preferably 25-35 minutes, and more preferably 30 minutes.

5. The vibration device for treating osteoporosis and increasing bone strength and bone density according to any one of claims 1, 2 or 4, characterized in that: It also includes a fixing mechanism for fixing the random vibration unit on the user's body; preferably, the fixing mechanism is configured to fix the random vibration unit in the lateral direction of the user's body, preferably, the fixing mechanism is configured to fix one or more random vibration units on at least one bone of the user, such as a hip joint, a femur, a spine, a knee joint, an ankle joint, a wrist, a thigh, or an upper arm.

6. The vibration device for treating osteoporosis and increasing bone strength and bone density according to any one of claims 1, 2 or 4, characterized in that: It also includes one or more motion information collectors for measuring the vibration acceleration generated by the user's motion; preferably, the motion information collector is an acceleration sensor.

7. The vibration device for treating osteoporosis and increasing bone strength and bone density according to any one of claims 1, 2 or 4, characterized in that: One or more pressure sensors may also be included to measure and ensure proper positioning and / or tensioning of the device.

8. The vibration device for treating osteoporosis and increasing bone strength and bone density according to any one of claims 1, 2 or 4, characterized in that: The random vibration unit includes a vibration element configured to generate mechanical vibration.

9. The vibration device for treating osteoporosis and increasing bone strength and bone density according to any one of claims 1, 2 or 4, characterized in that: The random vibration unit includes a random vibration generator programmed so that the vibration includes random vibration.

10. The vibration device for treating osteoporosis and increasing bone strength and bone density according to any one of claims 1, 2 or 4, characterized in that: It also includes at least one columnar structure in contact with the user's body, which is located on the contact unit of the random vibration unit and in contact with the user's body to transmit mechanical vibration to the user; the cross-section of the columnar structure is selected from hexagon, circle, oval, square, rectangle, trapezoid, polygon, and rhombus; the columnar structure is selected from shape memory alloy, high-density polymer foam, such as cross-linked polyethylene foam, silicone, TPU; the height of the column is 1-30mm, preferably 10-20mm; the columnar structure forms a shape that fits the human body on the contact surface with the user's body, preferably one or more curved surfaces that fit the shape of the user's sacrum, such as an arc, or a shape similar to an arc.

Images