CN117205063A

CN117205063A - Vibration device for treating osteoporosis and increasing bone strength and bone density

Info

Publication number: CN117205063A
Application number: CN202310913022.6A
Authority: CN
Inventors: 劳芳; 范俊东
Original assignee: Xiaoda Beijing Technology Co ltd
Current assignee: Xiaoda Beijing Technology Co ltd
Priority date: 2023-07-24
Filing date: 2023-07-24
Publication date: 2023-12-12

Abstract

The invention relates to a vibration device for treating osteoporosis, increasing bone strength and bone density, comprising at least one random vibration unit configured to generate mechanical vibrations, the mechanical vibrations comprising random vibrations; the mechanical vibrations are configured to apply a mechanical load to the user at a frequency and acceleration that produces a therapeutic effect on osteoporosis. It can be used for treating or preventing bone mass reduction, osteoporosis, stimulating bone growth, maintaining or enhancing bone density or bone strength.

Description

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

Technical Field

The present invention relates to the field of medical devices. More particularly, the present invention relates to a vibration device for treating osteoporosis, increasing bone strength and bone density.

Background

Osteoporosis is a disease characterized by low bone density, deterioration of bone tissue microstructure, destruction of bone microstructure, impaired bone strength, reduced bone mass, and susceptibility to fracture. In China, osteoporosis is a disease with serious diagnosis and treatment deficiency. Therefore, there is a great unmet need for how to effectively prevent, slow bone loss, promote bone growth and healing, and repair bone damage.

At present, the osteoporosis is treated by medicines, diet therapy, exercise and other methods, the medicines and diet therapy have long treatment time and limited remission rate, the compliance requirement on patients is high, and the medicine treatment also has the problem of easily inducing gastrointestinal reactions and even tumors. Exercise therapy is of particular interest because of its health, effectiveness and convenience. The exercise has definite curative effect on improving osteoporosis and written in guidelines for preventing and treating osteoporosis, and the mechanism is the stimulation of bone cells by mechanical vibration generated by the exercise. The osteoblast is proliferated by transmitting the mechanical stimulation signal, so that the bone tissue is adaptively rebuilt, and the anabolism of the bone is regulated and controlled. However, exercise therapy is also limited, and is not suitable for people with limited exercise or heart and lung diseases, and exercise injury can be caused by improper exercise of normal people. Therefore, it has application value to provide passive mechanical vibration to the body instead of active movement, thereby preventing osteoporosis and bone calcium loss. The optimum amplitude of the vibration stimulus is described in SU1344356A1 as 2-5 mm and the frequency as 25-60 hz. In 1999, power Plate improved and developed this technology to adapt it to both athletes and usual fitness enthusiasts, and explored applications in the field of rehabilitation medicine (Journal of Sports Sciences,1999,17, pp.177-182.) that by means of whole body vibration, subjects were allowed to stand on vibration devices to receive mechanical stimuli. In 2001, APOS MEDICAL ASSETS ltd. A wearable vibration device is disclosed, the vibration element of which vibrates at a frequency in the range of about 1-200Hz, inducing a strain in bone tissue in the range of about 1-500 microstrain (US 7462158B 2). While BONE HEALTH TECHNOLOGIES, INC. is based on adding acceleration sensor on the wearable vibration device, and applying 0.3-1.5g vibration stimulus to patient sacrum in 15-90Hz frequency range (US 10206802B 2).

The mechanism of the action of the conduction mechanical stimulus of mechanical vibration in bone tissue on osteogenesis is very complex, and any parameter variation may lead to differences in therapeutic effect. In the current literature and applications, parameters such as frequency, acceleration, duration of treatment, and interval of mechanical vibrations are of interest. Researches of students such as Zhang Jianguo and the like find that the vibration stress with the frequency of 0.5-1Hz can promote the formation of new bones, prevent osteoporosis, promote the healing of bone fracture, promote the growth of poroma and increase the strength and the rigidity of the healing place of bone fracture (image analysis of the influence of periodic load on experimental fracture healing, chinese orthopedics journal, 1995,4); 220-223). Shen Hua et al have considered that the optimum frequency for vibration stress to promote bone remodeling should be in the range of 10-50Hz, and that the structural characteristics and material properties of callus grown under stimulation at this frequency are good (the study of biomechanical experiments on the optimum frequency for vibration stress to promote bone remodeling, journal of China medicine, 2000, 80 (10): 795-796). These studies have conducted intensive comparisons and studies in terms of vibration frequency, amplitude and duration of treatment, interval, each yielding vibration stimulation conditions considered optimal.

However, none of the prior art focuses on the effect of the vibration type itself on bone growth. In these documents and in practice, most use is made of deterministic vibrations, i.e. periodic or quasi-periodic vibrations. Most of the vibration is applied to the object at regular rated frequency and the other of the vibration is applied to the object at periodic small-amplitude frequency conversion, and the vibration intensity used by the vibration is also mostly fixed. In life, whether in sports or other activities, the human body is actually exposed to a random vibration state, and the mechanical stimulus containing the random vibration is closer to the vibration mode of the natural state. In addition, the bone cells are also subjected to sensitive fatigue under the condition of single periodic vibration stimulation for a long time, and at the moment, the response of the bone cells to mechanical stimulation is reduced, the anabolism capability is reduced, and the treatment effect is affected.

In addition, since different people have different conditions in gender, age, genetic background, life experience, past medical history and basic bone conditions, and bone conditions are quite different, feedback to vibration stimulus is different, and uniform and monotonous vibration types are difficult to ensure that reactions are generated in all people. Accordingly, there is a need to provide a more versatile, fatigue-resistant vibration protocol that ensures that a greater number of subjects with different bone conditions will respond to vibration stimuli, thereby benefiting.

There is a need in the art to provide a vibration device that overcomes the shortcomings of the prior art.

Disclosure of Invention

The present invention has been made in view of the above-described problems, and an object thereof is to provide a vibration device for treating osteoporosis, increasing bone strength and bone density, which achieves the effects of stimulating bone tissue growth, helping bone tissue healing, preventing osteoporosis, slowing or suppressing occurrence of bone mass reduction, maintaining or increasing bone density and bone strength by giving a mechanical stimulus including random vibration to a subject.

The random vibration according to the present invention is known as random vibration in a known definition. Mechanical vibrations are classified into two major types, deterministic and stochastic, which are classified according to the characteristics of the vibrations that change over time. Random vibration is a relative concept of deterministic vibration, and if the value or amplitude of a force or motion acting on a system is determined at any given time, the vibration resulting from such force or motion is referred to as deterministic vibration. Random vibration refers to a force or motion of the system whose value or amplitude is unpredictable at any given time.

The invention adopts a mode containing random vibration to replace the existing fixed-frequency and regular-frequency vibration stimulation bone growth mode, and considers that the human body is always in a living environment containing random vibration, and in the long-term evolution process, the mechanical stimulation generated by random vibration is the most natural state for the regulation stimulation of a physical signal path on bone cells. In daily life, the ground movement such as wind speed, road surface roughness and earthquake is random vibration; the human body also contains random vibrations during free activities and sports such as running, riding, rope skipping, etc. The types of vibrations of an artificial installation, such as a mechanical device, although comprising deterministic vibrations, still inevitably comprise random vibrations, or a combination of some kind of vibrations. In actual operation, the periodic signal of the device is often submerged in the random vibration signal.

The single, periodic, regular vibration stimulus pattern can lead to fatigue of the bone cell response, thereby compromising bone growth. The signals containing random vibration can endow the bone cell physical signal path with longer-lasting growth stimulation, and are also more suitable for various crowds in different situations. The invention adopts a vibration mode comprising random vibration, so that the vibration device which can treat osteoporosis, promote bone tissue growth, reduce bone mass loss and promote healing of fracture is obtained. On an animal osteoporosis model, the treatment mode of random vibration is found to be superior to the periodic vibration treatment mode in all detection indexes, and has statistical difference in the aspects of improving the bone mineral content and increasing the connection density of bone trabeculae, so that unexpected technical effects are obtained.

In one aspect of the invention, a vibratory apparatus is provided that includes at least one random vibratory unit configured to generate mechanical vibrations, the mechanical vibrations comprising random vibrations.

In some of these embodiments, the mechanical vibration is configured to apply a mechanical load to the user at a frequency and acceleration that are preset and capable of producing a therapeutic effect on osteoporosis.

The random vibration of the present invention includes all types of random vibration conforming to well known definitions including, but not limited to, stationary random vibration and unstable random vibration, the former subdivision also including narrow band random vibration and wide band random vibration.

In some embodiments, the random vibration unit generates only random vibration, i.e., completely random vibration, which may be selected from stationary random vibration or non-stationary random vibration.

In some preferred embodiments, the random vibration is selected from smooth random vibration.

In a more preferred embodiment, the random vibration is a narrow-band random vibration or a wide-band random vibration, and more preferably a wide-band random vibration. A representative type of wideband random vibration is white noise, such as gaussian white noise.

In some embodiments, the vibration device encodes and stores random vibration data, such as Gaussian white noise data, and the random vibration generator enables the vibration element to generate corresponding random vibration and outputs the random vibration to the subject so as to achieve the purposes of stimulating bone tissue growth and preventing osteoporosis.

The random vibration generation methods disclosed in the prior art can be used for the random vibration scheme of the present invention. Such as references and books:

Wang Yongde, wang Jun, random signal analysis base fifth edition, electronic industry Press, 2020.03.

Zhu Hua, huang Huining, li Yongqing, mei Wenbo, random signal analysis: beijing university of the science and technology publishing agency 2021.07.

Wang Shikui, theory and practice of random signal analysis: university of eastern publishing agency, 2016.08.

[ reference 4 ] Crister Anla Andrographis; li Zhijiang the random vibration Beijing: national defense industry press, 2021.04.

Yan Xiangchao vibration theory and test techniques, xuzhou: chinese mining university Press, 2017.03.

[ reference 6 ] Crister Anla Andrographis; wu Sa, she Jianhua. Mechanical vibration and impact analysis sinusoidal vibration version 3.

Beijing: national defense industry press, 2021.04.

In some embodiments, the mechanical vibrations simulate vibrations generated when the human body moves, at which time the random vibration unit (3) generates a combination of random and deterministic vibrations. Wherein random vibration may be of any of the types described above, deterministic vibration may be periodic vibration, including but not limited to sine vibration, cosine vibration, or alternation of both; aperiodic vibration may also be used.

One of the embodiments of the combination of random vibration and deterministic vibration is to adopt a simulated motion mode, namely a vibration device encodes and stores data of vibration generated when a human body normally performs walking, jogging, running, climbing, rope skipping, riding and the like, and a random vibration generator (908) is used for enabling a vibration element to vibrate so as to achieve the purposes of stimulating bone tissue growth and preventing osteoporosis.

The implementation mode of the combination of random vibration and deterministic vibration can also adopt a self-defined mode, and the vibration device in the mode can collect vibration information of a user in walking, jogging, running, climbing, rope skipping, riding and other motion environments in real time, encode and store generated vibration data to obtain a vibration scheme suitable for the specific user, and then enable the vibration element to vibrate through the random vibration generator so as to achieve the purposes of stimulating bone tissue growth and preventing osteoporosis.

Methods known in the art can be used to generate deterministic vibrations of the present invention, as can be referenced:

Beijing: national defense industry press, 2021.04.

The frequency range of the vibration energy of the present invention is 10-100Hz, including any subranges therein, such as 10-70Hz,15-60Hz, and such as 15-45Hz; also included are any particular point value frequencies within this range, such as about 30Hz, or about 45Hz, or about 10Hz, or about 65Hz.

The vibration intensity ranges from 0.01 to 10g (where 1.0 g=earth gravitational field=9.8 m/s/s), and any subrange therein, such as from 0.01 to 4.0g, from 0.1 to 1.5g, from 0.3 to 1g, and any specific point value intensity within the range, such as about 0.3g or about 1.0g.

The time of use by the user may be selected from 3-7 times a week, such as 3-5 times, 4-5 times, preferably between 20-45 minutes, and preferably 25-35 minutes, such as 30 minutes, within 24 hours.

In some embodiments, the present invention may be implemented in a non-wearing manner of a cushion, seat cushion, or the like.

Another embodiment is to provide the vibration device as wearable, portable. At this time, the vibration device further includes a fixing mechanism for fixing the random vibration unit to the body of the user. The fixation mechanism is configured to fix one or more random vibration units to at least one bone of a user.

In some embodiments, the securing mechanism is configured to secure the random vibration unit in a lateral direction of the user's body.

In some embodiments of the invention, the securing mechanism of the device is secured to the shoulder of the individual to apply vibration to the back of the individual. In another aspect, an additional securing mechanism is secured to the person's waist to provide additional support to the device apparatus while the device applies vibrations to the person's back. In other embodiments, the securing mechanism is secured only to the waist or buttocks of the individual to impart vibrations at these locations. The location of the applied vibration can be adjusted to preferentially transmit the vibration to the spine, buttocks, or other location.

In some embodiments, the wearable vibration device provides effective treatment by targeted application of oscillating mechanical loads to the user's hip and spine.

In some embodiments, the device is worn on the sacrum and the vibrations are concentrated on the sacrum.

In some embodiments, the fixation mechanism is configured to fix one or more stochastic vibration units to at least one skeletal site of the user, such as a skeletal site of a hip joint, femur, limb, head, knee joint, ankle joint, wrist, leg, arm, or the like. This configuration is preferably a scaled down version of the device disclosed in embodiments of the present invention to be worn around the spine, waist or buttocks.

The wearable vibration device allows mechanical stimulation to be delivered in a side-to-side, front-to-back, and/or up-and-down direction. This flexibility of the delivery system allows for better targeting of the hip and spine in the treatment of osteoporosis and loss of bone mineral. More specifically, in one variation, one or more random vibration units may be positioned against the user's body via one or more securing mechanisms, respectively, configured to position the random vibration units in a lateral direction of the individual's body, thereby causing a mechanical load to be applied laterally to the user.

In an embodiment of the user-selected custom mode, the vibration device further comprises one or more motion information collectors for measuring the vibration acceleration generated by the one or more random vibration units. The motion information collector may select an acceleration sensor, position the acceleration sensor near a body part area where the user is receiving vibrations, and be configured to detect the resulting vibration energy transmitted into the body area of the user, providing a corresponding data basis for customizing the personalized vibration regime.

In some embodiments, the vibration device further comprises one or more pressure sensors for measuring to ensure proper positioning and/or tensioning of the device to ensure that the user has securely worn the device before starting the treatment.

In some embodiments, the random vibration unit includes a vibration element configured to generate mechanical vibrations. In another embodiment, the vibratory element comprises a vibratory weight that moves in a random or deterministic motion. The vibration element produces vibration at a frequency in the range of about 10-100Hz and a peak vibration acceleration in the range of about 0.1-1.5g, inducing strain in bone tissue in the range of about 1-500 microstrain.

In some embodiments, the random vibration unit includes a random vibration generator programmed such that the vibrations comprise random vibrations.

In order to ensure the efficiency of vibration transmission and the therapeutic effect, in some embodiments, the present invention further comprises at least one columnar structure in contact with the body of the user, the columnar structure being located on the contact unit of the random vibration unit, in contact with the body of the user, to transmit mechanical vibrations to the user.

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

In some embodiments, the height of the column is 1-50mm, preferably 10-30mm, more preferably 10-20mm; the columnar structure forms a closely conforming shape on the user's body-contacting surface, preferably one or more curved surfaces, such as arcs, or arc-like shapes, that conform to the shape of the user's sacrum.

In another aspect of the present disclosure, there is also included a method of treating or preventing osteoporosis, comprising:

securing one or more stochastic vibration units to the body of the user, wherein the one or more stochastic vibration units are configured to apply repeated mechanical loads to the bone site of the user at a frequency and acceleration preset and sufficient to produce a therapeutic effect on osteoporosis, the mechanical loads generated by the stochastic vibration units comprising stochastic vibrations.

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

Wherein one or more random vibration units apply repeated mechanical loads during the user's walk.

In some of these embodiments, the skeletal sites of the user are the hips, femur, and spine.

In some of these embodiments, the method further comprises monitoring the frequency and acceleration by one or more acceleration sensors.

In some of these embodiments, the method further comprises ensuring proper positioning and/or tensioning of the one or more vibrating elements by the one or more pressure sensors.

In another aspect, the invention also includes a method of increasing bone mineral content comprising:

securing one or more stochastic vibration units to the body of the individual, wherein the one or more stochastic vibration units are configured to apply repeated mechanical loads to the skeletal site of the individual at a preset frequency and acceleration sufficient to produce a therapeutic effect on osteoporosis; the mechanical load generated by the random vibration unit of (a) includes random vibration.

In another aspect, the invention also includes a method of promoting normal skeletal maturation comprising:

Advantageous effects

The invention has the following effects:

(1) The invention comprises mechanical stimulation of random vibration, is closer to the vibration mode in life, has more natural vibration mode and broader and coordinated vibration frequency/vibration intensity distribution, and has good bionic effect.

(2) Compared with the vibration mode of fixed frequency or regular frequency conversion, the invention can better stimulate the growth of bone cells of the organism, the sensitivity of the bone cells to vibration stimulation is not easy to be passivated or lost, the density of bone trabecula and the bone mineral content can be better increased,

(3) The vibration mode of random vibration of the invention comprises a wider spectrum and various vibration frequency/vibration intensity modes, so that the audience is wider, and people with different bone conditions, different ages and sexes can benefit.

(4) The invention comprises a vibration mode of random vibration, can achieve the same stimulation of vibration applied to bones in a short time as the traditional long-time movement, and can achieve the bone recovery and bone growth benefit as the movement when the user does not conveniently move.

These and other features, objects, and advantages of the present invention will become apparent to those skilled in the art upon a reading of the following, details of which are more fully described below.

Drawings

Fig. 1 illustrates an isometric view of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention.

Fig. 2 is a front view showing the internal structure of a random vibration unit of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention.

Fig. 3 is a flowchart showing generation and control of random vibration by the random vibration unit of the vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention.

Fig. 4 shows a flow chart of the operation of the vibration modes of the vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention.

Fig. 5 shows a fully random vibration mode partial magnified signal diagram of a vibration device for treating osteoporosis, increasing bone strength and bone density according to an embodiment of the invention.

Fig. 6 shows a full signal diagram of the completely random vibration modes of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention.

FIG. 7 shows a partially magnified signal diagram of a simulated slow walking vibration mode of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the invention.

Fig. 8 shows a simulated walkthrough vibration mode full signal diagram of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention.

Fig. 9 shows a partial magnified signal diagram of a simulated sprint vibration mode of a vibration device for treating osteoporosis, increasing bone strength and bone density according to an embodiment of the present invention.

Fig. 10 shows a simulated sprint vibration mode full signal plot of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention.

Fig. 11 shows a partially enlarged signal diagram of a simulated rope skipping vibration mode of a vibration device for treating osteoporosis, increasing bone strength and bone density according to an embodiment of the present invention.

Fig. 12 shows a simulated rope skipping vibration mode total signal diagram of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention.

Fig. 13 illustrates a 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.

Fig. 14 shows a schematic diagram of the workflow of the internal components of a random vibration unit of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention.

Fig. 15 shows a schematic view of the position of a pressure sensor in a vibration device according to an embodiment of the present invention.

Fig. 16 shows a vibration device including three vibration units of the vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention.

Fig. 17 shows a schematic view of a honeycomb section cylinder of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention.

Fig. 18 shows a side view of a honeycomb section cylinder of the vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention as shown in fig. 17.

FIG. 19 illustrates a block diagram of a data processing system that may be used with the vibration device of any of the embodiments of the present invention.

Fig. 20 is a schematic perspective view showing a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention.

Detailed Description

Fig. 1 illustrates an isometric view of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention. As shown in fig. 1, this embodiment is designed to be worn around the waist so that vibrational energy is applied to the hip/spine region of the user. In some embodiments, the apparatus is worn such that vibrational energy is concentrated on the sacrum. The securing mechanism 1 may secure the wearable vibration device to the body, such as the waist. The contact unit 2 is a component of a portion in direct contact with the body of the user, which is a 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 may also be a separate unit, directly contacting the random vibration unit 3, or connected to the random vibration unit 3 through the fixing mechanism 1, to conduct vibration. The random vibration unit 3 may contain 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 charge indicator light 906, a status indicator light 907, a motor 304, an encoder 904, a shaft 307, and other components and/or electronics. The contact unit 2 and the vibration unit 3 are connected through the fixing mechanism 1, the contact unit 2 and the vibration unit 3 can be fixed on the fixing mechanism 1, and can also move on the fixing mechanism 1, and the relative positions of the contact unit 2 and the vibration unit 3 are kept unchanged all the time during movement.

Fig. 2 is a front view showing the internal structure of a random vibration unit of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention. As shown in fig. 2, PCB board 305 is used to control the overall operation of the device. The battery 302 supplies power to the device, and the charge and discharge of the device are controlled by the PCB 305. The random vibration generator 908 is connected to the PCB board, and may be directly integrated on the PCB board, or may be an independent unit outside the PCB board, and receives a vibration generation instruction sent by the processor 901, and drives the motor 304 to vibrate according to the instruction. The motor 304 is centrally located and is rotated by a random vibration generator, and torque is transmitted to the vibration element 301 via the rotation shaft 307, generating vibration acceleration. The housing 303 serves to protect the internal components of the device, prevent dust, etc. The rotation shaft 307 and the vibration element 301 are both located in the center of the random vibration unit.

The vibration element 301 may be configured to apply repeated mechanical loads by any method known in the art. In some embodiments, the vibratory element 301 may include an oscillating element powered by a power source. For example, an electromagnetic weight may be attached to a spring mounted inside the vibration element 301 for oscillating movement and alternately attracted and repelled by a surrounding frame made of black material, i.e. an oscillating mass moving in a periodic movement. In some embodiments, the vibration element may be an ultrasonic transducer that induces vibrations of a desired amplitude. In some embodiments, the vibrating element is a slider-crank mechanism. In other embodiments, the vibration element 301 is an eccentric weight that produces vibration as it rotates.

In some embodiments, the vibration element 301 may 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 rotational frequency, which also varies the amplitude (motor frequency and amplitude are approximately linearly proportional over the 15Hz-60Hz motor frequency range). A motor may be coupled to and oriented within the assembly to transmit vibrations to a user.

Fig. 3 is a flowchart showing generation and control of random vibration by the random vibration unit of the vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention. As shown in fig. 3, first, the device is turned on, entering a pre-detection phase, indicated by 601. The PCB 305 is powered on and runs a power-on detection program, indicated at 602. The presence or absence of an abnormality in the components such as the motor 304 and the battery 302 is detected and indicated by 603. If there is an abnormality, an abnormality indicator light is turned on and the user needs to perform maintenance, indicated by 610. If there is no abnormality, the treatment mode and treatment time are set by the user, indicated by 608. After the setup is completed, the processor 901 will receive the relevant instructions and send a vibration generating signal to the random vibration generator 908, while the processor 901 starts timing, indicated by 607. Upon receiving the vibration generation signal, the random vibration generator 908 generates a voltage waveform capable of driving the motor 304 to rotate, and drives the vibration element 301 to generate vibration acceleration according to the relevant parameters. The processor 901 will monitor in real time whether the treatment time has been reached, indicated by 609. After the timer has expired, the treatment sequence ends, indicated at 611.

The random vibration therapy mode can be designed individually for people with different requirements and is completed by the random vibration unit 3. Modes that can be set as needed are: completely random mode, motion simulation mode, custom mode. The completely random mode is a random vibration signal which imitates the common disorder in the environment, and a user can adjust the parameters such as the frequency range, the amplitude, the power spectral density and the like of random vibration, and can also directly use equipment to preset the vibration mode. The motion simulation mode is to simulate the vibration generated by bones of a human body in the process of motion and exercise, and the simulated motion comprises and is not limited to: slow running, fast running, rope skipping, mountain climbing, riding, and the like. Custom modes are movements that the user can freely select for simulation. In the embodiment of the invention, the duration of the random vibration is preferably 25-45 minutes, preferably 30 minutes.

Fig. 4 shows a flow chart of the operation of the vibration modes of the vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention. As shown in fig. 4, a vibration therapy mode is first selected by a user, represented by block 701.

In some embodiments, the user may select a completely random pattern, represented by block 702, that simulates random vibrations generated by the user during normal motion, i.e., completely random vibrations generated by the motion. The vibration device generates a completely random signal, indicated by block 705, based on the preset parameters. The fully random signal of the present invention can be obtained by the nature 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 spectral density, distribution of the random signal, etc., the resulting signal is filtered through a bandpass filter to ensure that the vibration frequency and intensity are within the proper range for vibration stimulation bone growth (frequency 10-100Hz, intensity 0.01-1.5g in the present invention), a specific fully random signal scheme is obtained, represented by block 708. One embodiment of the invention uses random vibration amplitude at 0.8g and frequency in the range of 15-60Hz to generate random vibration for 30min, the local vibration signal mode is shown in figure 5, and the whole vibration signal mode is shown in figure 6 (the ordinate is intensity g, the abscissa is time, and 0.2s is interval multiplied by 104).

In some embodiments, the user may select a motion simulation mode, represented by block 703 of FIG. 4, and may select different motion types, such as fast walk, jogging, rope jump, hill climbing, and the like. The simulation is that the composite vibration generated during normal motion of a user is superposition of periodic vibration and completely random vibration, and has the property of approximate period. The invention adopts the general amplitude and acceleration when the motion is performed, the harmonic vibration frequency is 2rad/s when the motion is slow, and the acceleration intensity is 0.6g; the harmonic vibration frequency during fast running is 3.3rad/s, and the acceleration intensity is 0.8g; the harmonic vibration frequency during rope skipping was 1.3rad/s and the acceleration intensity was 1.2g. The apparatus of the present invention generates a corresponding periodic signal based on the vibrational characteristics of the different types of motion, represented by block 706 of block 4. Embodiments use the generation of periodic signals in the prior art to obtain vibration signals when simulating motion. The periodic signal generated is superimposed with the random signal generated in the completely random vibration mode described previously, indicated by block 709 of block 4, to obtain a composite vibration signal simulating various movements.

The intensity of the vibration in the examples varied between 0.2-1.5g like pulsation to simulate the vibration of a periodic motion. Finally, the harmonic signal of periodic vibration and the random signal of random vibration are synthesized into a composite signal, and the composite signal is filtered by a band-pass filter to ensure that the vibration frequency range is 15-60Hz, so that vibration simulating different types of motions is generated, and the mechanical stimulus generated in the range benefits the growth of human bones.

For example, in the present embodiment, the vibration signal at the jog time is simulated, the harmonic vibration frequency at the jog time is specified to be 2rad/s, and the vibration acceleration amplitude is 0.6g. The harmonic signal is generated as follows:

H＝0.6sin(2t+φ)

the random signal adopts a Gaussian white noise signal with the amplitude of 0.4g, the frequency range of 15-60Hz, the power spectrum density of one straight line, and according to the Gaussian distribution, the probability density function of the Gaussian distribution is known as follows:

in this example a standard gaussian distribution is used, i.e. μ=0, σ=1.

The harmonic signals and the random signals are overlapped to obtain the simulated slow-walking signals, and vibration signal mode diagrams of different motion signals can be generated by other types of motion signals through the method (the figures 7, 9 and 11 are local vibration signal diagrams; the figures 8, 10 and 12 are all vibration signal modes).

In some embodiments, the user may also select a custom mode, represented by block 704 of FIG. 4. The self-defined mode is suitable for people who want to simulate own motion more accurately and generate vibration, and the random vibration mode of each user suitable for different conditions is configured by measuring the actual motion condition of each user, so that the random vibration has the characteristic of personalized customization, the treatment is more accurate, and the better bone growth stimulation effect is obtained.

In the apparatus comprising the custom mode, the apparatus further comprises one or more motion information collectors 5, which are located inside the stochastic vibration unit 3, wherein one embodiment is to use an acceleration sensor 910 for measuring the vibration acceleration of the wearable vibration device. The vibration acceleration sensor may employ acceleration sensors of a type known in the art, including, but not limited to, an acceleration sensor that obtains data by measuring an electrical quantity of a varistor, an acceleration sensor that obtains data by measuring a capacitance change, and an acceleration sensor that obtains acceleration data by measuring a voltage change by an inverse piezoelectric effect using a piezoelectric ceramic plate.

When the user-defined mode is used, the user wears the device for normal movement, and the movement information collector detects movement information, such as acceleration and the like, of the user when the user wears the wearable vibration device for movement in real time, and measures 30 minutes. The motion information is passed to the processor 901 for operation. The processor performs processing steps such as filtering analysis and feature extraction on the acceleration data, extracts information of vibration generated during movement, sends a vibration generation signal to the random vibration generator 908, and adjusts relevant parameters of simulated movement according to the self-defined movement condition, so that more accurate vibration treatment suitable for the self condition of each user is realized. After the parameters are stored, the user can directly use the stored vibration parameters for treatment.

The right side flow of fig. 4 shows that when the custom mode is adopted, the motion information collector measures the analog quantity of the vibration acceleration signal when the user moves, and sets the corresponding vibration parameters according to the measurement result, and the vibration parameters can be saved in the processor for the next use after the setting is completed, which is indicated by a block 707. After the measurement is completed, the user may then invoke the saved motion pattern in the processor to simulate any motion using the device, as represented by block 710. After the generation of the signal of the required vibration acceleration is completed, the processor 901 receives the related instruction, sends the vibration generating signal to the random vibration generator 908, converts the signal into a voltage signal and applies the voltage signal to the motor 304, which is represented by a block 711, and can implement negative feedback adjustment control on the motor 304 through the motor encoder, so that the vibration acceleration generated by the motor 304 can exactly meet the generated signal of the required vibration acceleration. Finally, the motor 304 begins to move, represented by block 712.

The above three random vibration modes are just three typical random vibration modes of embodiments of the present invention. Without limitation, the present invention may also employ a random vibration scheme generated by the existing random vibration theory, so long as the vibration frequency and intensity fall within the appropriate ranges for stimulating bone growth, all belong to the embodiments of the present invention that can be implemented for stimulating bone growth by random vibration.

Fig. 13 illustrates a 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 fig. 13, first the processor 901 receives an instruction to generate a vibration signal, represented by block 801. If the vibration initiation parameters (fully random mode or simulated motion mode) are specified using the preset mode, indicated by block 804, the vibration signal initiation parameters in memory may be directly invoked, indicated by block 805. If custom parameters are used, information is first acquired by the motion information acquirer, as represented by block 802. After the acquisition is completed, the acquired motion information is imported into the processor 901, and corresponding vibration parameters, such as vibration amplitude, vibration frequency, phase, etc., corresponding to the vibration signal are extracted, as represented by block 803. After extraction, the vibration parameters are saved for next use, represented by block 806.

After the vibration parameters are obtained, a verification process is first performed to confirm that the vibration data is within the allowable range of the human body, as represented by block 805. The resulting vibration parameters are then transmitted to a random vibration generator 908, represented by block 807. The random vibration generator 908 generates a random signal and/or a harmonic signal based on the relevant parameters, as represented by block 808. The resulting signals are first superimposed (the step is skipped for the completely random mode) and then filtered, indicated by block 809. Which in turn is converted to a voltage signal applied to the motor 304, indicated by block 811. The motor encoder 904 detects its rotational speed through inverse feedback modulation to control its precise operation, as represented by block 810. Ultimately producing a vibration signal, represented by block 812. The frequency of the random vibration energy of the embodiment of the invention is about 10-100Hz per second, and the intensity range of the random vibration is 0.01-1.5g.

Fig. 14 shows a schematic diagram of the workflow of the internal components of a random vibration unit of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention. As shown in fig. 14, a processor 901, a battery management module 902, a buzzer/alarm 903, a random vibration generator 908, etc. are all located on the PCB board 305. The buzzer/alarm 903 is used for alarming, and the battery management module 902 is responsible for managing the charging and discharging of the battery. The random vibration generator 908 may be located on the PCB 305 or may be independent of the PCB for generating a vibration signal for driving the motor to rotate. The PCB 305 is within the housing 303 along with other components such as a battery 302, a motor 304, a motor encoder 904, a motion information collector (in this embodiment, an acceleration sensor) 910, and the like. The battery 302 is used to provide power, the motor 304 is used to generate torque, and the encoder 904 is used to feedback control the motor rotation. The housing 303 has a charging port 909, a power switch 905, a charging indicator 906, a status indicator 907, a pressure sensor 4, and the like.

In addition to the aforementioned motion information collectors, 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. The pressure sensor can measure the wearing condition of a user, and the pressure is used for judging whether the wearing position is wrong, the wearing is too loose or too tight and the like. Upon detecting the above problem, a signal is transmitted to the processor 901, which may indicate to the user via the display device the adjustment method, prompting the user how the device should be adjusted, such as adjusting the position of the device, tightening or loosening the device. The adjustment mode can be automatically adjusted by a mechanical device controlled by a processor, and also can be manually adjusted by a user.

Fig. 15 shows a schematic view of the position of a pressure sensor in a vibration device according to an embodiment of the present invention. As shown in fig. 15, the fixing mechanism 1 fixes the wearable vibration device to the waist. The contact unit 2 can be directly attached to the waist of a user, the pressure sensor 4 is distributed on the surface of the contact unit 2, and data of the pressure sensor can be transmitted to the processor through wired or wireless signals.

One or more of the pressure sensors in the above embodiments may be placed anywhere on the wearable vibration device, including straps, bands, securing mechanisms, motors, spacers, containers, and the like. In some embodiments, the sensor may be physically separate from the device, but in wired or wireless communication with the processor of the device. Further, one or more alarms may be included in the wearable vibration device to alert the user to adjust the degree of matching. Various types of alarms may be used, including audible, visual, such as flashing lights, tactile, such as pulses of a vibration motor, etc. The alarm may sound for a set period of time, or until the match is improved, or both. Additionally or alternatively, the securing mechanism of the wearable vibration device may be self-adjusting based on feedback from the fitness sensor. This may be achieved by a motor, a thermal mechanism, a mechanical mechanism, an electrical mechanism, etc.

In some embodiments, the wearable vibration device may include both the pressure sensor 4 and the motion information collector 5. The pressure sensor is in physical contact with the user. The pressure sensor 4 detects the pressure caused by the motor vibration and the overall tightness of the wearable vibration device on the user's body before, during or after the motor is turned on. An example of the motion information collector 5 is an acceleration sensor 910, which is used to collect acceleration during motion and generate an acceleration analog, so that an algorithm in the processor can calculate parameters required by vibration.

In some embodiments, the fixation mechanism 1 secures the vibration device to the lumbar region, where the vibration device may be secured in a location such as the sacrum, hip bone, etc., that is susceptible to being conducted vibrations. In other embodiments, the vibration device is secured to other areas of the body to exert a prophylactic or therapeutic effect. For example, the wearable vibration device may be designed to be worn on the neck, back, extremities, head, foot, etc. These embodiments include, but are not limited to: the vibrations may be by means of a wristband or elbow ring, knee pad, shoe or sock, or otherwise strapped or otherwise secured to the wrist, elbow, knee, foot or other portion of the lower limb. Vibration stimuli delivered to the wrist, elbow, foot or lower limb are also helpful in treating osteoporosis or other diseases.

The fixing means 1 may take any shape and any suitable material. For example, the securing mechanism 1 may 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, having one or more housings for containing the random vibration unit 3.

The securing mechanism 1 may be in the form of a vest and may include one or more sleeves or shoulder straps for the subject's upper limb. The securing mechanism 1 may also include, but is not limited to, shoe-type, wrist-support, knee-support, ankle-support, waistband-type, shorts-type. The securing mechanism may secure the random vibration unit 3 to the torso of the individual in any manner, such as, but not limited to, velcro, hooks, snaps, buttons, zippers, ties (e.g., laces), adhesives, and the like. The random vibration unit 3 need not be contained within the housing and may be attached to the securing mechanism 1 in any other way, such as, but not limited to, by bonding, embedding, etc. The fixing mechanism 1 may have any length, width and thickness.

Embodiments of the vibration device of the present invention may be used in the prevention, treatment and rehabilitation of osteoporosis, femoral head necrosis, reduced bone mass, hypoplasia, various types of fractures. In addition, sacroiliac joint (SI) syndrome, SI arthropathy, SI instability, SI blockage, myalgia and tendinopathy in the pelvic region, pelvic ring instability, and in the case of structural disturbances following lumbar fusion, for preventing recurrent SI blockage and myopathies (rectus abdominis, piriformis), joint fracture and relaxation, back pain, cartilage strengthening, and other conditions can be treated.

The vibrating device of the present invention comprises at least one random vibrating unit 3. In some embodiments, a plurality of random vibration units may be selectively provided according to circumstances. One representative example is shown in fig. 16, fig. 16 shows a vibration device of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention, which comprises three random vibration units, the positions of which may be fixed on the fixing mechanism 1 or may be moved so that the three random vibration units may be located at arbitrary positions of the body, such as one random vibration unit located at the sacrum position, and the other two random vibration units located at hip bone positions of both sides, particularly the hip crest position. Three random vibration units can also be arranged in parallel or perpendicular orientation to the spine at the sacral site, or in combination with other bone placement.

The vibration energy of the different random vibration units may be configured as a combination and synergy of the same or different types of vibration modes and schemes. As in some of these embodiments, the different random vibration units may all select a completely random vibration mode, or a combination of two different vibration modes may be used, such as a combination of custom and simulated motion modes, or a combination of custom and completely random vibration modes.

Different random vibration units may be configured to orient in different directions, more than one direction, alternating directions, different directions simultaneously, etc.; or the vibration energy of different random vibration units may vary with time, increase/decrease amplitude, increase/decrease frequency, change direction, cycle through a program, turn on and off, etc. The stimulus vibrations may also comprise different kinds of waveforms. For example square, triangular, saw tooth, sinusoidal, etc. These different waveforms may introduce harmonics of the fundamental frequency and may provide enhancement or additional benefits. The plurality of frequencies may also be superimposed on each other in the random vibration unit. Multiple vibrating devices may be worn. Multiple vibratory units may be used to cancel, increase, or change the vibratory energy applied to the user, either partially or entirely. Vibration energy may be transferred 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 to reduce osteonecrosis around the plate. This embodiment of the device may be used periodically, possibly daily or weekly or monthly, to reduce necrosis of the bone.

In some examples, one to a plurality of columns perpendicular to the contact surface may be provided on the contact unit 2, fig. 17 shows different views of a honeycomb-section column of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention, and fig. 18 shows a side view of a honeycomb-section column of a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention as shown in fig. 17. As shown in fig. 17 and 18, these columns can be adjusted in height according to the specific condition of the contact surface with the human body, so as to form the ergonomic contact unit 2 which is more fit with the contact surface of the human body, so as to increase the comfort of the human body, increase the fit tightness with the human body, and ensure and improve the kinetic energy transmission efficiency. The columns may occupy a portion of the contact surface or may fully occupy the entire contact surface. The columns may or may not taper.

In some embodiments, the cylinder cross-section may be a honeycomb equilateral hexagon, in other embodiments, the cylinder cross-section may be any of a variety of other shapes including irregular hexagons, circles, ovals, squares, rectangles, trapezoids, polygons, diamonds, and the like.

In some embodiments, the column is rigid or semi-rigid. The column body can use shape memory alloy to carry out self-adaptive fitting on the waist curve of the user. In other embodiments, the post can freely stretch out and draw back along the axial, and automatic movement to appropriate position stops when wearing to the human body of adaptation different statures increases the laminating degree. For example, the cylinder can be pushed to move to a proper position by liquid, and the valve is automatically closed after the adjustment is finished, so that the position of the cylinder is locked.

The cylinder may 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, and silicone, TPU, and the like. The height of the column is 1-30mm, preferably 10-20mm. The ergonomic shape formed is one or more curved surfaces, such as arcs, or arc-like shapes, that conform to the shape of the user's sacrum.

FIG. 19 illustrates a block diagram of a data processing system that may be used with the vibration device of any of the embodiments of the present invention. For example, the system may be used as part of a processor. Note that while fig. 19 illustrates various components of a computer system, it is not intended to represent any particular architecture or manner of interconnecting the components; as these details are not germane to the present invention. It will also be appreciated that network computers, hand held computers, mobile devices, tablet computers, cell phones and other data processing systems having fewer components or perhaps more components may also be used with the present invention.

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

The volatile RAM 1002 is typically implemented as Dynamic RAM (DRAM) which continuously requires power in order to refresh or maintain the data in the memory. The non-volatile memory 1003 is typically a magnetic hard disk 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, the non-volatile memory 1003 will also be a random access memory, however this is not required.

Nonvolatile memory 1003 may be a local device coupled directly to the rest of the components in the data processing system or nonvolatile memory 1003 may be utilized remotely from the system; such as a network storage device coupled to the data processing system through a network interface, such as a modem or ethernet interface. The buses 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, the I/O control unit 1006 may also include a USB adapter for controlling USB (universal serial bus) peripherals. Alternatively, the control unit 1006 may include an IEEE-1394 adapter, also known as a firewire adapter, for controlling firewire devices, SPI (serial peripheral interface), I2C (internal integrated circuit) or UART (universal asynchronous receiver/transmitter), or any other suitable technology. Wireless communication protocols may include Wi-Fi, bluetooth, zigBee, near field, cellular, and other protocols.

Fig. 20 is a schematic perspective view showing a vibration device for treating osteoporosis, increasing bone strength and bone density according to one embodiment of the present invention. As shown in fig. 20, it shows a battery 302, three parts of a housing 303 (a contact unit 2 in contact with the body of a user, a housing rear portion 911 in direct contact with the contact unit 2, and a housing front portion in which a liquid crystal display 308 is mounted, respectively), a printed circuit board assembly (PcB) 305, a screw 912, a motor 304, a rotation 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). The plate may be a 0.1 "aluminum plate.

The vibration equipment is mounted to the stationary unit by means of the contact unit 2. A strip-shaped neoprene rubber, which is a part of the fixing unit, is clamped between the contact unit 2 and the front of the housing 303 using 4 screws 912.

The vibrating device of the present invention may also be provided in the form of a seat cushion or pad. The contact unit 2 itself or a seat plate connected to the random vibration unit 3 and vibrating, optionally also a pad containing a wrapped seat plate, and a layer containing foam or other lining. The seat pan may be metal, polymer or any other suitable material. Preferably, the plate is rigid or semi-rigid. The plate is shaped to hold the bones of the buttocks to maximize the transfer of vibrational energy from the plate to the bones. The processor and random vibration generator may be incorporated into the pad or may be a separate device that is connected to the control board wirelessly or by wire. The user places the seat cushion/cover on a chair or other surface and sits atop the seat cushion so that the buttock area, including the protruding bones that make up the ischium, is in contact or near contact with the plate. There may be a filling cover between the plate and the user. Vibration energy is transferred from the plate to the ischium and bones, typically to the lower back and hip areas. The vibrational energy may be horizontal, vertical, or both. In this embodiment, the weight of the user helps ensure that the device is properly "matched" to the body.

The vibration device may also be in the form of a back cushion placed against the seat back with the plate area of the device in contact with the hip, sacrum, e.g., ilium. In this embodiment, a strap may be included to increase the access of the vibratory device to the hip area.

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

Vibration therapy may also be performed with forces and frequencies to treat pain, muscle paralysis, aversion to cold, and digestive disorders.

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. The techniques shown in the figures may 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 memories, read only memories, flash memory devices, phase change memories) and transitory computer-readable transmission media (e.g., electrical, optical, acoustical or other form of propagated signals such as carrier waves, infrared signals, digital signals)) to store code and data (internally and/or over a network with other electronic devices) and transmit the code and data.

The processes or methods depicted in the preceding figures may be performed by processing logic that comprises hardware (e.g., circuitry, dedicated logic, etc.), firmware, software (e.g., embodied on a non-transitory computer readable medium), or a combination of both. Although a process or method is described above in terms of some sequential operations, it should be appreciated that some of the operations described may be performed in a different order. Moreover, some operations may be performed in parallel rather than sequentially.

Any feature of any embodiment disclosed herein may be used with other embodiments.

Effect example 1: treatment effect of random bionic vibration device on osteoporosis of New Zealand rabbits

Experimental materials and methods

1. 60 female New Zealand-series pure-bred white rabbits (Gift Biotechnology Co., ltd.) of 2.8+ -0.25 kg body weight, 6 months old, were selected as model animals.

2. The ovarian castration is carried out by adopting an ovarian resection method, and the ovarian castration comprises the following operation steps: 10% chloral hydrate (sigma company in U.S.) was injected intraperitoneally for 0.35g/kg anesthesia, with the abdomen in the supine position facing upwards, the New Zealand rabbits were fixed on the rabbit operating table, the hair in the rabbit operating field was shaved, the iodophor was sterilized, and the bilateral ovaries of the female rabbits were surgically removed. The bone density of lumbar vertebra (BMD) was measured with an X-ray bone densitometer (GE company in the United states) 3 days before the operation, and after 4 months after the operation, BMD of the proximal ends of lumbar vertebra and femur was measured again with an X-ray bone densitometer, and the successful establishment of the osteoporosis animal model was determined. The criterion for successful modeling was that the mean of BMDs of all animals was lower than the mean before castration minus 2.0SD.

3. After confirming that the modeling was successful, 60 osteoporosis rabbits were randomly divided into 6 groups, namely a blank control group (group a, without vibration stimulation), a positive control group (group B, with regular sinusoidal vibration at 30 Hz), a completely random vibration group (group C), a simulated jogging group (group D), a simulated jogging group (group E), and a simulated rope skipping group (group F). Wherein C-F correspond to the vibration modes shown in fig. 8, 10 and 12, respectively. Animals of groups B-F were fixed on a rabbit table and received vibration treatment at the lumbar spine for 33 minutes each time, once a day, for 3 months. 10 animals in each group are fed quantitatively (200 g/d), and the animals are free to drink water, and the feeding temperature is 20-25 ℃ and the relative humidity is 40-70%.

4. After 3 months of vibration treatment, each sample of the control group and each experimental group was sacrificed by ear vein air embolism, the distal femur was separated, 10 specimens of each group were placed in Micrio-CT (GE-LSPmicro-CT, GE company, USA) sample cups, and scanned under the same conditions (44 mLtube-21 μm-150mins, threshold: 1044), BMD and Bone Mineral Content (BMC) were measured, and the bone trabecular number, thickness, connection density, and bone volume ratio were analyzed for Liang Liti measurement indexes.

5. And (5) carrying out statistical treatment. Mean ± standard deviation for dataThe analysis of variance and LSD-t test were performed using SPSS11.0 statistical software.

Experimental results and analysis

1. Results of animal model establishment for osteoporosis

The BMD mean of all animals before castration and the BMD mean of all animals after castration were compared and the results are shown in Table 1. The results in Table 1 show that BMD at the proximal ends of the lumbar vertebrae and femur of rabbits after castration is significantly reduced, and the difference from BMD before castration has statistical significance (P < 0.05), and modeling is successful.

TABLE 1 New Zealand rabbits BMD determination results (mg/cm) at the proximal lumbar vertebra and femur before and after castration ² .)

Measuring time	Lumbar vertebra	Proximal femur
			Before castration	292±28	289±35
After castration	179±21	182±37

2. BMD and BMC test results for each group after random vibration treatment

Table 2 records the BMD and BMC results at the distal femur in the control and experimental groups, and the statistical results show that the BMD and BMC averages are significantly higher at the distal femur in the B-F groups than in the control group, with statistical differences. There was no statistical significance for the differences in BMD between groups B and C-F, and between groups C-F, but the values of C-F were higher for the random vibration groups than for group B, whereas on BMC there was no statistical difference between C-F, but there was a statistical significance for their differences from group B. This demonstrates that with the random vibration mode of the present invention, it is possible to achieve an effect of increasing bone mineral density that is not unlike the conventional periodic frequency conversion mode, and it is possible to better increase bone mineral content in an osteoporotic subject.

TABLE 2 distal femur BMD and BMC results

The distal femur bone fragments Liang Zhibiao were measured for each group of animals and the results obtained are shown in table 3. The results in Table 3 show that the differences between the detection indexes of the A group and the B-F group are statistically significant. Whereas the differences in BV/TV and trabecular junction density measurements were statistically significant for groups B and C-F, and for groups C-F, the TB.N, tb.Sp and Tb.Th measurements were all higher than for group B, and in some random vibration groups there was also a statistical significance for differences in TB.N and Tb.Sp compared to group B. The bone trabecula is the most active component of bone metabolism, because it approaches the bone marrow space, but bone trabecula is also extremely easy to be influenced by local or systemic disturbance factors to cause bone metabolism unbalance, and the random vibration mode of the invention can better promote bone trabecula growth and inhibit bone unbalance compared with the traditional mode.

TABLE 3 results of the measurement of femur distal bone fragments Liang Liti

Effect example 2: treatment effect of random bionic vibration device on osteoporosis of menopausal women

In a volunteer collection mode, a similar experimental study is adopted to select women with average ages of 49.43 +/-3.43 years (the ages of 43-58 years) in the transition period of 60 menopause and early menopause, which meet the osteoporosis standard, are brought into the study, and randomly divided into 3 groups, wherein the two groups are random bionic vibration groups, vibration treatment is carried out by using the random bionic vibration device shown in the figure 20 of the invention, and the other group is a control group. The random bionic vibration group observes the clinical effect of vibration on bone loss resistance by applying random vibration within the frequency range of 30-50 Hz to a human body. The subjects were classified into vibration groups A1 to A2 and a control group B. Group A1 employs the completely random vibration pattern of fig. 5-6 and group A2 employs the simulated rope skipping pattern of fig. 11-12.

According to the expected treatment scheme, one treatment course is 6 months, and vibration treatment is carried out 5 times per week for 30min.

Heart rate and blood pressure meters were issued to subjects in group A1-A2, and blood pressure and heart rate of the subjects needed to be measured and recorded before and after each treatment. The original living habit of each study group object is kept unchanged. Bone density of the whole body, lumbar vertebrae 2-4, and femoral neck of the subject was measured before and after treatment.

Statistical analysis was performed using SAS (version 9.2). And adopting a paired sample t test to respectively compare the self bone density conditions before and after the intervention of the vibration group study object and before and after the follow-up of the control group study object. The vibration/follow-up bone density changes of subjects in the vibration group and the control group were compared using two independent sample t-tests.

The examination apparatus is a DEXA bone density detector (bone density meter).

At present, the research is still in progress, in the preliminary spot check detection of bone density for 3 months, the decrease speed of the bone density of a vibration group study object is observed to be slow compared with that of a control group study object, and the random bionic vibration device has the effect of treating osteoporosis.

Claims

1. A vibration device for treating osteoporosis, increasing bone strength and bone density, comprising at least one stochastic vibration unit configured to generate mechanical vibrations comprising stochastic vibrations configured to apply mechanical loads to a user at a preset frequency and acceleration.

2. The vibration apparatus for treating osteoporosis, increasing bone strength and bone density according to claim 1, wherein said mechanical vibration is a random vibration selected from the group consisting of stationary random vibration and non-stationary random vibration; preferably, the random vibration is selected from stationary random vibration, more preferably, the random vibration is narrow-band random vibration or wide-band random vibration.

3. The vibration device for treating osteoporosis, increasing bone strength and bone density according to claim 1 or 2, wherein said mechanical vibration simulates vibration generated when a human body moves, said mechanical vibration being a combination of random vibration and deterministic vibration; the random vibration is selected from one of stable random vibration and unstable random vibration; preferably, the random vibration is selected from stationary random vibration, 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. A vibration device for treating osteoporosis, increasing bone strength and bone density according to claim 3, wherein the random vibration unit produces vibrations in the frequency range of about 10-100Hz, preferably 10-70Hz, more preferably 15-60Hz; the peak acceleration generated by the random vibration unit ranges from about 0.01 g to about 1.5g, preferably from about 0.3 g to about 1g; the mechanical vibration comprises a treatment time of between 20 and 45 minutes, preferably 25 to 35 minutes, more preferably 30 minutes, within 24 hours.

5. The vibration apparatus for treating osteoporosis, increasing bone strength and bone density of any one of claims 1, 2 or 4, further comprising a securing mechanism for securing said random vibration unit to the body of the user; preferably, the fixation mechanism is configured to fix the random vibration unit in a lateral direction of the user's body, preferably the fixation mechanism is configured to fix one or more random vibration units on at least one bone of the user, such as the hip joint, femur, spine, knee joint, ankle joint, wrist, thigh, upper arm.

6. The vibration apparatus for treating osteoporosis, increasing bone strength and bone density of any one of claims 1, 2 or 4, further comprising one or more motion information collectors for measuring the vibration acceleration produced by the user's motion; preferably, the motion information collector is an acceleration sensor.

7. The vibration device for treating osteoporosis, increasing bone strength and bone density of any one of claims 1, 2 or 4, further comprising one or more pressure sensors for measuring to ensure proper positioning and/or tensioning of the device.

8. The vibration apparatus for treating osteoporosis, increasing bone strength and bone density of any one of claims 1, 2 or 4, wherein said random vibration unit comprises a vibration element configured to produce mechanical vibrations.

9. The vibration apparatus for treating osteoporosis, increasing bone strength and bone density of any one of claims 1, 2 or 4, wherein said random vibration unit comprises a random vibration generator programmed such that said vibrations comprise random vibrations.

10. The vibration apparatus for treating osteoporosis, increasing bone strength and bone density of any one of claims 1, 2 or 4, further comprising at least one columnar structure in contact with the body of the user, said columnar structure being located on the contact unit of the random vibration unit in contact with the body of the user to conduct mechanical vibrations to the user; the section of the columnar structure is selected from hexagon, circle, ellipse, square, rectangle, trapezoid, polygon and diamond; the columnar structure is selected from shape memory alloy, high density polymer foam, such as cross-linked polyethylene foam, silica gel, TPU; the height of the column is 1-30mm, preferably 10-20mm; the columnar structure forms a shape that conforms to the human body on the surface in contact with the user's body, preferably one or more curved surfaces, such as arcs, or arc-like shapes, that conform to the shape of the user's sacrum.