CN117205063A - A vibration device for treating osteoporosis and increasing bone strength and density - Google Patents

Abstract

The invention relates to a vibration device for treating osteoporosis and increasing bone strength and bone density, which includes at least one random vibration unit configured to generate mechanical vibration. The mechanical vibration includes random vibration; the mechanical vibration is configured to The frequency and acceleration with which osteoporosis produces a therapeutic effect imposes mechanical loads on the user. It can be used to treat or prevent osteopenia, osteoporosis, stimulate bone growth, maintain or enhance bone density or bone strength.

Description

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

Technical field

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

Background technique

Osteoporosis is a disease characterized by low bone density, deterioration of bone tissue microstructure, destruction of bone microstructure, impaired bone strength, osteopenia, and susceptibility to fractures. Osteoporosis is a severely underdiagnosed and undertreated disease in our country. Therefore, there is a huge unmet need in how to effectively prevent and slow down bone loss, promote bone growth and healing, and repair bone damage.

Currently, there are treatments for osteoporosis such as drugs, diet, and exercise. Drugs and diet therapy take a long time, have limited remission rates, and require high patient compliance. Drug treatments also have problems that can easily cause gastrointestinal reactions and even induce tumors. . Exercise therapy has received special attention because of its health, effectiveness and convenience. Exercise has a definite effect on improving osteoporosis and has been included in the guidelines for the prevention and treatment of osteoporosis. The mechanism is due to the stimulation of bone cells by mechanical vibration generated by exercise. By conducting mechanical stimulation signals, osteoblasts proliferate, causing adaptive reconstruction of bone tissue and regulating bone anabolism. However, exercise therapy also has limitations and is not suitable for people with limited exercise or people with cardiopulmonary diseases. In addition, improper exercise for normal people can also lead to sports injuries. Therefore, it has application value to provide the body with passive mechanical vibration to replace active motion to prevent osteoporosis and bone calcium loss. SU1344356A1 records that the optimal amplitude of 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 SportsSciences, 1999, 17, pp. 177 -182.), which uses whole-body vibration to allow subjects to stand on a vibrating device to receive mechanical stimulation. In 2001, APOS MEDICAL ASSETS LTD. disclosed a wearable vibration device. The vibration element of the device vibrates at a frequency in the range of approximately 1-200 Hz, causing a strain in the bone tissue in the range of approximately 1-500 microstrain ( US7462158B2). On this basis, BONE HEALTH TECHNOLOGIES, INC. adds an acceleration sensor to the wearable vibration device and applies 0.3-1.5g vibration stimulation to the patient's sacrum in the frequency range of 15-90Hz (US10206802B2).

The mechanism of the conduction of mechanical vibration in bone tissue and the effect of mechanical stimulation on osteogenesis is very complex, and changes in any parameters may lead to differences in therapeutic effects. In current literature and applications, attention is paid to parameters such as frequency, acceleration, treatment duration and intervals of mechanical vibration. For example, Zhang Jianguo and other scholars have found that vibration stress with a frequency between 0.5-1Hz can not only promote new bone formation and prevent osteoporosis, but also promote fracture healing, promote the growth of callus, and increase the strength and stiffness of the fracture healing site. (Image analysis of the effect of cyclic loading on experimental fracture healing, Chinese Journal of Orthopedics, 1995, 4); 220-223). Research by Shen Hua et al. believes that the optimal frequency for vibration stress to promote bone reconstruction should be 10-50Hz, and believes that the structural characteristics and material properties of callus grown under the stimulation of this frequency are better (the optimal frequency for vibration stress to promote bone reconstruction Biomechanical experimental research, Chinese Medical Journal, 2000, 80(10): 795-796). These studies conducted in-depth comparisons and studies in terms of vibration frequency, amplitude, treatment duration and intervals, and each concluded the optimal vibration stimulation conditions.

However, without exception, existing technologies have not paid attention to the impact of the vibration type itself on bone growth. In these literatures and practical applications, the vast majority use deterministic vibration, that is, periodic vibration or quasi-periodic vibration mode. Most of them apply vibration to the object at a regular rated frequency, and a small part uses periodic small-amplitude frequency conversion to apply vibration to the object. The vibration intensity used is mostly a fixed intensity. In life, whether it is exercising or engaging in other activities, the human body is actually exposed to a state of random vibration. Only mechanical stimulation containing random vibration is closer to the natural state of vibration mode. 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 anabolic ability will be weakened, which will affect the therapeutic effect.

In addition, since different groups of people have different situations in terms of gender, age, genetic background, life experience, past medical history and basic bone quality conditions, their bone quality conditions vary widely. Therefore, the feedback to vibration stimulation is different, and it is difficult to guarantee a uniform and monotonous vibration type. Produce reactions in all groups of people. Therefore, it is necessary to provide a more universal and fatigue-resistant vibration scheme to ensure that more subjects with different bone conditions can respond to vibration stimulation and benefit from it.

There is a need in this field to provide a vibration device that can overcome the shortcomings of the existing technology.

Contents of the invention

The present invention is proposed in view of the above problems, and its purpose is to provide a vibration device for treating osteoporosis and increasing bone strength and bone density. The device stimulates the growth of bone tissue by giving a subject mechanical stimulation including random vibration. Help bone tissue heal, prevent osteoporosis, slow down or inhibit the occurrence of osteopenia, maintain or increase bone density and bone strength.

The random vibration described in the present invention is random vibration according to the commonly known definition. Mechanical vibration is divided into two types: deterministic and random, which are divided according to the changing characteristics of vibration in the time history. Random vibration is a relative concept of deterministic vibration. If the value or amplitude of the force or motion acting on the system is determined at any given time, the vibration caused by this force or motion is called deterministic vibration. Random vibration means that the value or amplitude of a system's force or motion is unpredictable at any given time.

The present invention uses a mode containing random vibration to replace the existing vibration stimulation method of fixed frequency and regularly variable frequency to stimulate bone growth. This is because the human body is always in a living environment containing random vibration. In the process of long-term evolution, random vibration occurs. The mechanical stimulation to regulate the physical signaling pathways on bone cells is the closest to the natural state. Random vibrations occur in daily life such as wind speed, road surface roughness, and ground movement during earthquakes; the human body also contains random vibrations during free activities and sports, such as running, cycling, rope skipping, etc. Although the vibration types of artificial facilities such as mechanical equipment include deterministic vibration, they still inevitably contain random vibration, or a combination of certain vibration types. In actual operation of equipment, its periodic signals are often submerged in random vibration signals.

A single, periodic pattern of regular vibration stimulation will cause bone cell response fatigue, thereby reducing the bone growth effect. Signals containing random vibrations can provide bone cell physical signaling pathways with more lasting growth stimulation, and are also more suitable for various types of people in different situations. By adopting a vibration mode including random vibration, the present invention obtains a vibration device that can treat osteoporosis, promote bone tissue growth, reduce bone loss, and promote fracture healing. In animal osteoporosis models, it was found that the random vibration treatment mode was superior to the periodic vibration treatment mode in all test indicators, and there were statistical differences in increasing bone mineral content and increasing the connection density of trabecular bone, achieving Unexpected technical effects.

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

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

Random vibration in the present invention includes all types of random vibration that meet the commonly known definitions, including but not limited to stationary random vibration and unsteady random vibration. The former can also be subdivided into narrow-band random vibration and wide-band random vibration.

In some embodiments, the random vibration unit only generates random vibration, that is, completely random vibration, and the random vibration can be selected from stationary random vibration or unstable random vibration.

In some preferred embodiments, the random vibrations are selected from stationary random vibrations.

In a more preferred embodiment, the random vibration is narrow-band random vibration or broad-band random vibration, and more preferably wide-band random vibration. The representative type of broadband 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, uses a random vibration generator to cause the vibration element to generate corresponding random vibrations, and outputs random vibrations to the subject to stimulate bone tissue growth. The purpose of preventing osteoporosis.

All random vibration generation methods disclosed in the prior art can be used in the random vibration solution of the present invention. If you can refer to literature and books:

[Reference 1] Wang Yongde and Wang Junzuo, Fundamentals of Random Signal Analysis. Fifth Edition, Electronic Industry Press, 2020.03.

[Reference 2] Zhu Hua, Huang Huining, Li Yongqing, Mei Wenbo, eds. Random signal analysis. Beijing: Beijing Institute of Technology Press, 2021.07.

[Reference 3] Wang Shikui, ed. The Theory and Practice of Random Signal Analysis. Nanjing: Southeast University Press, 2016.08.

[Reference 4] (French) Written by Christian Lalan; translated by Li Zhiqiang. Random vibration. Beijing: National Defense Industry Press, 2021.04.

[Reference 5] Edited by Yin Xiangchao. Vibration Theory and Testing Technology. Xuzhou: China University of Mining and Technology Press, 2017.03.

[Reference 6] (French) Written by Christian Lalan; translated by Wu Sa and Ye Jianhua. Mechanical Vibration and Impact Analysis of Sinusoidal Vibration 3rd Edition.

Beijing: National Defense Industry Press, 2021.04.

In some embodiments, the mechanical vibration simulates the vibration generated when the human body moves. At this time, the random vibration unit (3) generates a combination of random vibration and deterministic vibration. The random vibration can use any of the above types, and the deterministic vibration can use periodic vibration, including but not limited to sine vibration, cosine vibration, or alternating between the two; non-periodic vibration can also be used.

One type of implementation of the combination of random vibration and deterministic vibration is to use simulated motion mode, that is, the vibration device encodes data of vibrations generated when the human body performs regular movements such as walking, jogging, running fast, climbing, skipping rope, riding, etc. And stored, the random vibration generator (908) causes the vibration element to vibrate, so as to stimulate the growth of bone tissue and prevent osteoporosis.

The implementation of the combination of random vibration and deterministic vibration can also adopt a custom mode. In this mode, the vibration device can collect real-time vibration information of the user in walking, jogging, fast running, mountain climbing, rope skipping, riding and other sports environments, which will generate The vibration data is encoded and stored to obtain a vibration plan suitable for the specific user, and then the vibration element is vibrated through the random vibration generator to achieve the purpose of stimulating the growth of bone tissue and preventing osteoporosis.

Known methods in the prior art can be used to generate the deterministic vibration of the present invention, for example, reference can be made to:

[Reference 6] (French) Written by Christian Lalan; translated by Wu Sa and Ye Jianhua. Mechanical Vibration and Impact Analysis of Sinusoidal Vibration 3rd Edition.

Beijing: National Defense Industry Press, 2021.04.

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

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

The user can choose 3-7 times a week, such as 3-5 times, 4-5 times, and the treatment time within 24 hours is between 20-45 minutes, preferably 25-35 minutes, such as 30 minutes.

In some embodiments, the present invention can be implemented in non-wearable forms such as cushions and seat cushions.

Another embodiment is to configure the vibration device to be wearable and portable. At this time, the vibration device also includes a fixing mechanism for fixing the random vibration unit on the user's body. The fixation mechanism is configured to fix one or more random vibration units to at least one bone of the 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 device's securing mechanism is secured to the individual's shoulders to apply vibration to the individual's back. On the other hand, additional anchoring mechanisms are secured to the individual's waist to provide additional support to the device while the device applies vibrations to the individual's back. In other embodiments, the securing mechanism is secured only to the individual's waist or hips to apply vibration at these locations. The location where the vibration is applied can therefore be adjusted to preferentially deliver the vibration to the spine, hips or other locations.

In some embodiments, wearable vibration devices provide effective therapy by applying oscillatory mechanical loads in a targeted manner to the user's hips and spine.

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

In some embodiments, the fixation mechanism is configured to fix one or more random vibration units on at least one skeletal part of the user, such as a hip joint, a femur, a limb, a head, a knee joint, an ankle joint, a wrist, a leg, an arm and other skeletal parts. This configuration is preferably a scaled-down version of the device disclosed in embodiments of the invention, to be worn around the spine, waist, or hips.

This wearable vibration device allows the delivery of mechanical stimulation in the left-right, front-back and/or up-down 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 may each be positioned against the user's body via one or more fixation mechanisms configured to position the random vibration units in a lateral direction of the individual's body on the user, thereby placing mechanical loads laterally on the user.

In the implementation of the user-selected custom mode, the vibration device further includes one or more motion information collectors for measuring vibration acceleration generated by one or more random vibration units. The motion information collector can select an acceleration sensor, position the acceleration sensor near the user's body part area that receives vibration, and be configured to detect the resulting vibration energy transmitted to the user's body area, providing corresponding responses for customized personalized vibration solutions. Data base.

In some embodiments, the vibrating device also includes one or more pressure sensors for measuring to ensure correct positioning and/or tensioning of the device to ensure that the device is securely worn by the user before initiating treatment.

In some embodiments, the random vibration unit includes a vibration element configured to generate mechanical vibration. In another embodiment, the vibrating element includes a vibrating weight that moves with random or deterministic motion. The vibration frequency generated by the vibrating element is in the range of about 10-100 Hz, the vibration peak acceleration is in the range of about 0.1-1.5g, and the strain in the bone tissue is induced 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 effect of treatment, in some embodiments, the vibration device of the present invention further includes at least one columnar structure in contact with the user's body. The columnar structure is located on the contact unit of the random vibration unit and is in contact with the user's body. contact to transmit mechanical vibrations to the user.

In some embodiments, the cross-section of the columnar structure can be of any shape, including but not limited to circles, ovals, squares, rectangles, trapezoids, polygons, rhombuses, etc. The most suitable shape is preferably rhombus. The material of the columnar structure is selected from any material that can ensure that the required vibration energy is transmitted to the user's body, such as rigid or semi-rigid materials with a density of 30-45kg/m3, including but not limited to shape memory alloys, high-density polymer foam, Such as cross-linked polyethylene foam, silicone, TPU, etc.

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

In another aspect, the present disclosure also includes a method of treating or preventing osteoporosis, including:

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 to the user's skeletal parts at a preset frequency and acceleration sufficient to produce a therapeutic effect on osteoporosis. Repeated mechanical loads, including random vibrations, are generated by random vibration units.

In some of the embodiments, the random vibration unit applies a mechanical load on at least one skeletal part of the user's body, preferably in a transverse direction of the user's body.

One or more random vibration units apply repetitive mechanical loads during the user's walking.

In some of these embodiments, the user's skeletal regions are the hip, femur, and spine.

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

In some of these embodiments, the method further includes ensuring correct positioning and/or tensioning of the one or more vibrating elements via one or more pressure sensors.

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

One or more random vibration units are fixed to the individual's body, wherein the one or more random vibration units are configured to apply to the individual's skeletal parts at a preset frequency and acceleration sufficient to produce a therapeutic effect on osteoporosis. Repeated mechanical loading; the mechanical loading produced by the random vibration unit includes random vibration.

In some of the embodiments, the random vibration unit applies a mechanical load on at least one skeletal part of the user's body, preferably in a transverse direction of the user's body.

One or more random vibration units apply repetitive mechanical loads during the user's walking.

In some of these embodiments, the user's skeletal regions are the hip, femur, and spine.

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

In some of these embodiments, the method further includes ensuring correct positioning and/or tensioning of the one or more vibrating elements via one or more pressure sensors.

In another aspect, the present invention also includes a method for promoting normal skeletal maturation, including:

One or more random vibration units are fixed to the individual's body, wherein the one or more random vibration units are configured to apply to the individual's skeletal parts at a preset frequency and acceleration sufficient to produce a therapeutic effect on osteoporosis. Repeated mechanical loads; Random vibration units Mechanical loads generated include random vibrations.

In some of the embodiments, the random vibration unit applies a mechanical load on at least one skeletal part of the user's body, preferably in a transverse direction of the user's body.

One or more random vibration units apply repetitive mechanical loads during the user's walking.

In some of these embodiments, the user's skeletal regions are the hip, femur, and spine.

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

In some of these embodiments, the method further includes ensuring correct positioning and/or tensioning of the one or more vibrating elements via one or more pressure sensors.

beneficial effects

The invention has the following effects:

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

(2) Compared with vibration modes of fixed frequency or regular variable frequency, 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 easy to be blunted or lost, and can better Increase the density and bone mineral content of trabecular bone,

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

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

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

Description of the drawings

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

Figure 2 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.

Figure 3 shows a flow chart for 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.

Figure 4 shows a flow chart 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.

Figure 5 shows a partial amplified signal diagram 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.

Figure 6 shows the complete signal diagram of the completely random vibration mode of the vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

Figure 7 shows a partial amplified signal diagram of a simulated slow walking vibration mode of a vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

Figure 8 shows the entire signal diagram of the simulated slow walking vibration mode of the vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

Figure 9 shows a partial amplified signal diagram of a simulated fast running vibration mode of a vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

Figure 10 shows the entire signal diagram of the simulated fast running vibration mode of the vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

Figure 11 shows a partial amplified signal diagram of a simulated skipping rope vibration mode of a vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

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

Figure 13 shows the 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.

Figure 14 shows a schematic diagram of the work flow 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.

Figure 15 shows a schematic diagram of the position of the pressure sensor in the vibration device according to one embodiment of the present invention.

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

Figure 17 shows a schematic diagram of a honeycomb cross-section cylinder of a vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

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

Figure 19 shows a block diagram of a data processing system that may be used with a vibration device of any embodiment of the present invention.

Figure 20 shows a schematic three-dimensional structural view of a vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention.

Detailed ways

Figure 1 shows an isometric view 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 1, this embodiment is designed to be worn around the waist so that vibrational energy is applied to the hip/spine area of the user. In some embodiments, the device is worn so that vibrational energy is focused on the sacrum. The fixing mechanism 1 can fix the wearable vibration device to the body, such as the waist. The contact unit 2 is a component that is in direct contact with the user's body. It 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 can also be used as an independent unit to directly contact the random vibration unit 3, or be connected to the random vibration unit 3 through the fixing mechanism 1 to conduct 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, and a code. 904, shaft 307, and other components and/or electronics. The contact unit 2 and the vibration unit 3 are connected through the fixed mechanism 1. The contact unit 2 and the vibration unit 3 can be fixed on the fixed mechanism 1, or they can move on the fixed mechanism 1. When moving, the contact unit 2 and the vibration unit 3 always maintain their relative positions. constant.

Figure 2 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. As shown in Figure 2, PCB board 305 is used to control the overall operation of the device. The battery 302 supplies power to the device, and the PCB board 305 controls its charging and discharging. The random vibration generator 908 is connected to the PCB board, and can be directly integrated on the PCB board, or can be used as an independent unit outside the PCB to receive the vibration generation instructions sent by the processor 901, and drive the motor 304 to vibrate according to the instructions. The motor 304 is located in the center and rotates driven by the random vibration generator. The torque is transmitted to the vibration element 301 through the rotating shaft 307 to generate vibration acceleration. The shell 303 plays a role in protecting the internal components of the device and preventing dust. The rotating shaft 307 and the vibration element 301 are both located in the center of the random vibration unit.

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

In some embodiments, vibrating element 301 may generate vibration using a powered eccentric rotating mass motor controlled by pulse width modulation (PWM). The duty cycle of the motor PWM can be changed to tune the rotational frequency, which also changes the amplitude (motor frequency and amplitude are approximately linearly proportional over the motor frequency range of 15Hz-60Hz). The motor can be attached to and oriented within the component to deliver vibrations to the user.

Figure 3 shows a flow chart for 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. As shown in Figure 3, first, the device is turned on and enters the pre-detection stage, represented by 601. The PCB board 305 is powered on and runs the power-on detection program, represented by 602. Detect whether the motor 304, battery 302 and other components are abnormal, represented by 603. If there is an abnormality, the abnormal indicator light will light up and the user needs to perform maintenance, which is represented by 610. If there is no abnormality, the user sets the treatment mode and treatment time, represented by 608. After the setting is completed, the processor 901 will receive the relevant instructions and send the vibration generation signal to the random vibration generator 908. At the same time, the processor 901 starts timing, represented by 607. After receiving the vibration generation signal, the random vibration generator 908 generates a voltage waveform that can drive the motor 304 to rotate according to the relevant parameters, and drives the vibration element 301 to generate vibration acceleration. The processor 901 will monitor in real time whether the treatment time is reached, represented by 609. After the timer expires, the treatment process ends, indicated by 611.

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

Figure 4 shows a flow chart 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. As shown in Figure 4, the user first selects a vibration therapy method, represented by box 701.

In some embodiments, the user may select a completely random mode, represented by block 702, which simulates random vibrations generated by the user during normal movement, that is, completely random vibrations generated by movement. The vibration device generates a completely random signal according to preset parameters, represented by block 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 spectral density, distribution of the random signal, etc., the generated signal is filtered through a band-pass filter to ensure that the vibration frequency and intensity are within the appropriate range for vibration to stimulate bone growth. Within (the frequency of the present invention is 10-100Hz, the intensity is 0.01-1.5g), thereby obtaining a specific completely random signal scheme, represented by box 708. One embodiment of the present invention uses a random vibration amplitude of 0.8g and a frequency of 15-60Hz to generate random vibration for 30 minutes. The local vibration signal pattern is shown in Figure 5, and the entire vibration signal pattern is shown in Figure 6 (vertical The coordinate is intensity g, the abscissa is time, 0.2s is the interval, multiplied by 104).

In some embodiments, the user can select a motion simulation mode, represented by block 703 in Figure 4, and can select different motion types, such as brisk walking, jogging, skipping, mountain climbing, etc. It simulates the composite vibration generated during normal movement of the user. It is a superposition of periodic vibration and completely random vibration, and has approximately periodic properties. The present invention adopts the general amplitude and acceleration when engaging in such sports. The harmonic vibration frequency during slow walking is 2rad/s and the acceleration intensity is 0.6g; the harmonic vibration frequency during fast running is 3.3rad/s and the acceleration intensity is 0.8. g; the harmonic vibration frequency during rope skipping is 1.3rad/s, and the acceleration intensity is 1.2g. The device of the present invention generates corresponding periodic signals according to the vibration characteristics of different types of motion, represented by block 706 of block diagram 4. The embodiment adopts the periodic signal generation method in the prior art to obtain the vibration signal during simulated motion. The generated periodic signal is superimposed with the random signal generated according to the aforementioned completely random vibration method, represented by block 709 of block diagram 4, to obtain a composite vibration signal that simulates various motions.

In the embodiment, the intensity of the vibration changes in a pulsating manner between 0.2-1.5g to simulate the vibration of periodic motion. Finally, the harmonic signal of periodic vibration and the random signal of random vibration are synthesized into a composite signal, which is filtered by a band-pass filter to ensure that the vibration frequency range is 15-60Hz, thereby generating vibrations that simulate different types of motion. Within this range The resulting mechanical stimulation benefits human bone growth.

For example, in this embodiment, the vibration signal during slow walking is simulated, the harmonic vibration frequency during slow walking is specified to be 2rad/s, and the vibration acceleration amplitude is 0.6g. The generated harmonic signal is:

H＝0.6sin(2t+φ)

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

In this example, the standard Gaussian distribution is used, that is, μ=0, σ=1.

By superimposing harmonic signals and random signals, a simulated slow-moving signal is obtained. Other types of motion signals can also be generated through 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 show all vibration signal modes).

In some embodiments, the user may also select a custom mode, represented by block 704 of FIG. 4 . The custom mode is suitable for people who want to more accurately simulate the vibrations caused by their own movements. This mode measures the actual movement of each user and configures a random vibration mode suitable for each user in different situations, thereby making random vibrations possible. It has the characteristics of personalized customization, making the treatment more precise and achieving better bone growth stimulation effect.

In the equipment containing the custom mode, the equipment also includes one or more motion information collectors 5. The motion information collectors are located inside the random vibration unit 3. One specific implementation method is to use an acceleration sensor 910 to measure the possible Vibration acceleration of wearable vibrating devices. The vibration acceleration sensor can use acceleration sensors of known types in the prior art, including but not limited to acceleration sensors that obtain data by measuring the electrical quantity of a varistor, acceleration sensors that obtain data by measuring changes in capacitance, and acceleration sensors using Piezoelectric ceramic sheet, an acceleration sensor that measures voltage changes to obtain acceleration data through the inverse piezoelectric effect.

When using the custom mode, the user wears the equipment of the present invention and performs normal exercise, and the motion information collector will detect the user's motion information, such as acceleration, etc., in real time while wearing the wearable vibration device, and measure for 30 minutes. The motion information will be passed to the processor 901 for calculation. The processor performs processing steps such as filtering analysis and feature extraction on the acceleration data, extracts the vibration information generated during movement, and sends the vibration generated signal to the random vibration generator 908 to adjust the relevant parameters of the simulated movement according to the custom movement situation. This enables more precise vibration therapy that is suitable for each user's own situation. After the parameters are saved, the user can directly use the saved vibration parameters for treatment.

The process on the right side of Figure 4 shows that when the custom mode is used, the motion information collector measures the vibration acceleration signal analog quantity when the user is exercising, and sets the corresponding vibration parameters according to the measurement results, represented by box 707. After the vibration parameter setting is completed Can be saved to the processor for next use. After the measurement is completed, the user can achieve the effect of using this device to simulate any motion by calling up the motion mode saved in the processor, represented by box 710. After generating the required vibration acceleration signal, the processor 901 receives the relevant instructions and sends the vibration generation signal to the random vibration generator 908, and then converts the signal into a voltage signal and applies it to the motor 304, represented by block 711. And the motor encoder can be used to realize negative feedback adjustment control of the motor 304, so that the vibration acceleration generated by the motor 304 can exactly match the generated required vibration acceleration signal. Finally, motor 304 begins to move, represented by block 712 .

The above three random vibration modes are just three typical random vibration modes in the embodiment of the present invention. Without limitation, the present invention can also adopt the random vibration scheme generated by the existing random vibration theory. As long as the vibration frequency and intensity fall within the appropriate range for stimulating bone growth, the random vibration stimulation of bone growth of the present invention is an implementable scheme.

Figure 13 shows the 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. As shown in Figure 13, first the processor 901 receives an instruction to generate a vibration signal, represented by block 801. If the preset mode is used to specify the initial parameters of the vibration (completely random mode or simulated motion mode), represented by block 804, then the initial parameters of the vibration signal in the memory can be directly called, represented by block 805. If custom parameters are used, information needs to be collected by the motion information collector first, represented by box 802. After the collection is completed, the collected motion information is imported into the processor 901, and corresponding vibration parameters consistent with the vibration signal are extracted, such as vibration amplitude, vibration frequency, phase, etc., represented by block 803. After the extraction is completed, the vibration parameters are saved for next use, represented by block 806.

After obtaining the vibration parameters, a verification process needs to be performed first to confirm that the vibration data is within the acceptable range of the human body, represented by box 805. The resulting vibration parameters are then transferred to a random vibration generator 908, represented by block 807. The random vibration generator 908 generates random signals and/or harmonic signals based on relevant parameters, represented by block 808 . The obtained signals are first superimposed (this step is skipped for completely random mode), and then filtered, represented by block 809. This is then converted into a voltage signal in the random vibration generator and applied to the motor 304, represented by block 811. The motor encoder 904 detects its rotational speed and controls its precise operation through inverse feedback adjustment, represented by block 810 . Finally, a vibration signal is generated, represented by block 812. The frequency of random vibration energy in the embodiment of the present invention is about 10-100Hz per second, and the intensity range of random vibration is 0.01-1.5g.

Figure 14 shows a schematic diagram of the work flow 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. As shown in Figure 14, the processor 901, the battery management module 902, the buzzer/alarm 903, the 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 battery charging and discharging. The random vibration generator 908 can be located on the PCB board 305, or can be independent from the PCB board, and is used to generate vibration signals that drive the motor to rotate. The PCB board 305 together with other components such as the battery 302, the motor 304, the motor encoder 904, the motion information collector (acceleration sensor in this embodiment) 910, etc. are all inside the housing 303. 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 outer shell 303 has a charging port 909, a power switch 905, a charging indicator light 906, a status indicator light 907, a pressure sensor 4 and other components.

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 use the pressure to determine whether there are problems such as incorrect wearing position, too loose or too tight wearing. When the above problem is detected, the signal is transmitted to the processor 901, and the processor can provide information to the user through the display device to indicate the adjustment method, 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-controlled mechanical device, or manually adjusted by the user.

Figure 15 shows a schematic diagram of the position of the pressure sensor in the vibration device according to one embodiment of the present invention. As shown in Figure 15, the fixing mechanism 1 fixes the wearable vibration device to the waist. The contact unit 2 can directly fit the user's waist. The pressure sensor 4 is distributed on the surface of the contact unit 2, and its data is transmitted to the processor through wired or wireless signals.

One or more pressure sensors in the embodiments described above can be placed anywhere on the wearable vibration device, including straps, straps, securing mechanisms, motors, spacers, containers, etc. In some embodiments, the sensor may be physically separate from the device but in wired or wireless communication with the device's processor. Additionally, one or more alarms may be included in the wearable vibrating device to alert the user to adjust the fit. Various types of alarms are available, including audible, visual, such as flashing lights, tactile, such as pulses from a vibrating motor, etc. The alarm can sound for a set period of time, or until the match improves, or both. Additionally or alternatively, the fixation mechanism of the wearable vibration device may self-adjust based on feedback from the fit sensor. This can be achieved by motors, thermal mechanisms, mechanical mechanisms, electrical mechanisms, etc.

In some embodiments, the wearable vibration device may include a pressure sensor 4 and a motion information collector 5 at the same time. The pressure sensor is in contact with the user's body. The pressure sensor 4 detects the pressure caused by the vibration of the motor 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 quantity to facilitate the algorithm system in the processor to calculate the parameters required for vibration.

In some embodiments, the fixing mechanism 1 fixes the vibration device on the waist. In this case, the vibration device can be fixed on the sacrum, hip bone, and other locations where vibration is easily transmitted. In other embodiments, the vibration device is fixed on other areas of the body to exert preventive or therapeutic effects. For example, wearable vibration devices can be designed to be worn on the neck, back, limbs, head, feet, etc. These embodiments include, but are not limited to, vibrations that may be delivered through devices such as wristbands or elbow rings, knee braces, shoes, or socks, or strapped or otherwise fixed to wrists, elbows, knees, feet, or other parts of the lower limbs. Vibratory stimulation delivered to the wrists, elbows, feet or lower limbs can also help treat osteoporosis or other conditions.

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

The immobilization mechanism 1 may be in the form of a vest and may include one or more sleeves or straps for the subject's upper limbs. The fixing mechanism 1 may also include, but is not limited to, shoe type, wrist type, knee type, ankle type, belt type, and shorts type. The fixation mechanism can fix the random vibration unit 3 on the individual's torso in any way, such as but not limited to Velcro, hooks, buckles, buttons, zippers, ties (such as shoelaces), adhesives, etc. The random vibration unit 3 does not have to be contained within the housing, and may be connected to the fixed 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.

Embodiments of the vibration device of the present invention can be used in the prevention, treatment and rehabilitation of osteoporosis, femoral head necrosis, osteopenia, bone hypoplasia, and various types of fractures. In addition, it can be used to treat sacroiliac joint (SI) syndrome, SI arthropathy, SI instability, SI obstruction, myalgia and tendinopathy in the pelvic area, pelvic ring instability, and in cases of structural disorder after lumbar fusion. For the prevention of recurrent SI obstruction and myopathy (rectus abdominis, piriformis), joint rupture and laxity, back pain, cartilage strengthening, and other conditions.

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

The vibration energy of different random vibration units can be configured as a combination and synergy of the same or different vibration modes and schemes. For example, in some embodiments, different random vibration units can all select completely random vibration modes, or a combination of two different vibration modes can be used, such as a combination of a custom mode and a simulated motion mode, or a custom mode and a completely random vibration mode. Synergy and combination of random vibration patterns.

Different random vibration units can be configured to orient in different directions, more than one direction, alternating directions, different directions at the same time, etc.; or the vibration energy of different random vibration units can change over time, increase/decrease amplitude, Increase/decrease frequency, change direction, cycle through programs, turn on and off, etc. Stimulating vibrations can also include different kinds of waveforms. For example, square, triangle, zigzag, sine waveform, etc. These different waveforms can introduce harmonics of the fundamental frequency and can provide enhancement or additional benefits. Multiple frequencies can also be superimposed on each other in a random vibration unit. Multiple vibration devices can be worn. Multiple vibration units may be used to partially or fully cancel, increase or modify the vibration energy applied to the user. Vibrational energy can be transmitted transcutaneously to the implanted metal plate. For example, a vibrating device could be placed on the outer surface of the leg to vibrate a metal bone plate within the leg to reduce osteonecrosis around the plate. This embodiment of the device may be used periodically, perhaps daily or weekly or monthly, to reduce bone necrosis.

In some embodiments, one or more cylinders perpendicular to the contact surface can be provided on the contact unit 2. Figure 17 shows a vibration method for treating osteoporosis and increasing bone strength and bone density according to an embodiment of the present invention. Different views of the honeycomb cross-section cylinder of the device. Figure 18 shows the side of the honeycomb cross-section cylinder of the vibration device for treating osteoporosis and increasing bone strength and bone density according to one embodiment of the present invention as shown in Figure 17 view. As shown in Figures 17 and 18, the height of these columns can be adjusted according to the specific conditions of the contact surface with the human body, forming an ergonomic contact unit 2 that better fits the human body contact surface, so as to increase the comfort of the human body and increase the connection with the human body. The tightness of the human body's fit ensures and improves the efficiency of kinetic energy transmission. The cylinder can occupy part of the contact surface or completely occupy the entire contact surface. The column may or may not be tapered.

In some embodiments, the cross-section of the cylinder can be a honeycomb-shaped equilateral hexagon. In other embodiments, the cross-section of the cylinder can also be an irregular hexagon, a circle, an ellipse, a square, a rectangle, or a trapezoid. , polygon, rhombus and any other various shapes.

In some embodiments, the column is rigid or semi-rigid. The column can use shape memory alloy to adaptively fit the user's waist curve. In other embodiments, the cylinder can freely expand and contract along the axial direction, and automatically moves to and stops at an appropriate position when worn, so as to adapt to human bodies of different sizes and increase the fit. For example, liquid can be used to push the column to the appropriate position, and the valve can be automatically closed after the adjustment is completed to lock the column position.

The column can be made of all materials that can effectively transmit vibration energy, including but not limited to high-density polymer foam, such as cross-linked polyethylene foam, as well as materials such as silicone and TPU. The height of the column is 1-30mm, preferably 10-20mm. The ergonomic shape formed is 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.

Figure 19 shows a block diagram of a data processing system that may be used with a vibration device of any embodiment of the present invention. For example, the system may be used as part of a processor. Note that while Figure 19 illustrates various components of a computer system, it is not intended to represent any particular architecture or manner of interconnecting components; as these 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 possibly more components may also be used with the present invention.

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

Volatile RAM 1002 is typically implemented as dynamic RAM (DRAM), which continuously requires power in order to refresh or maintain data in memory. Non-volatile memory 1003 is typically a magnetic hard drive, magnetic optical drive, optical drive, or 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 random access memory, however this is not required.

Non-volatile memory 1003 may be a local device coupled directly to the remaining components in the data processing system, or non-volatile memory 1003 may be utilized remotely from the system; such as, coupled through a network interface (such as a modem or Ethernet interface) Network storage devices to data processing systems. A bus may include one or more buses connected to each other through various bridges, controllers, and/or adapters, as is 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) peripheral devices. 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 (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.

Figure 20 shows a schematic three-dimensional structural view 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 the battery 302, three parts of the housing 303 (respectively the contact unit 2 that is in contact with the user's body, the rear portion 911 of the housing that is in direct contact with the contact unit 2, and the liquid crystal display screen). 308), printed circuit board assembly (PcB) 305, screws 912, motor 304, rotating shaft 307, eccentric shaft 309, processor 901, random vibration generator 908. The housing may include a housing made of ABS (acrylonitrile butadiene styrene plastic). The plate can be 0.1” aluminum plate.

The vibration equipment is mounted to the fixed unit via the contact unit 2. The strip of neoprene that is part of the fastening unit is sandwiched between the contact unit 2 and the front of the housing 303 using 4 screws 912.

The vibration device of the present invention may also be provided in the form of a seat cushion or pad. The contact unit 2 itself or the seat panel connected to the random vibration unit 3 and vibrating may also optionally include padding covering the seat panel, and a layer containing foam or other lining material. The seat pan can be metal, polymer or any other suitable material. Preferably the plate is rigid or semi-rigid. The plate is shaped to cradle the bones of the hip to maximize the transfer of vibrational energy from the plate to the bone. The processor and random vibration generator may be incorporated into the pad, or may be a separate device that is connected wirelessly or via wire to the control board. The user places the seat pad/cover on a chair or other surface and sits on top of the seat pad such that the hip area including the prominent bones that make up the sit bones is in or near contact with the board. There can be a padded covering between the board and the user. Vibrational energy is transferred from the plate to the sit bones and bones, usually to the lower back and hip areas. Vibrational energy can be horizontal, vertical, or both. In this embodiment, the user's weight helps ensure that the device "fits" properly to the body.

The vibrating device may also be in the form of a backrest pad, placed against the seat back, with the plate area of the device in contact with the hip bone, sacrum, for example the ilium. In this embodiment, a strap may be included to increase the access of the vibrating device to the hip bone area.

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

Vibration therapy can also be performed at a force and frequency that treats ailments such as pain, muscle paralysis, chills, and digestive disorders.

It should be clear, however, that all content in these and similar terms is to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. The techniques illustrated 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 (eg, 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, acoustic or other forms of propagated signals, such as carrier waves, infrared signals, digital signals)) to store code and data and to transmit code and data (internally and/or through other electronic devices over a network).

The processes or methods depicted in the preceding figures may be performed by processing logic including hardware (eg, circuitry, dedicated logic, etc.), firmware, software (eg, 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 recognized that some of the operations described may be performed in a different order. Furthermore, some operations may be performed in parallel rather than sequentially.

Any features of any embodiment disclosed herein can be used with other embodiments.

Effect Example 1: Therapeutic effect of random bionic vibration device on osteoporosis in New Zealand rabbits

Experimental materials and methods

1. Select 60 female New Zealand purebred white rabbits (Changsha Tianqin Biotechnology Co., Ltd.) that are 6 months old and weigh 2.8±0.25kg as modeling animals.

2. Use the method of ovariectomy to perform castration treatment. The operation steps of ovarian castration are: intraperitoneally inject 10% chloral hydrate (American Sigma Company) 0.35g/kg anesthesia, lie in a supine position with the abdomen upward, and fix the New Zealand rabbit to the rabbit during surgery. On the stage, the hair of the rabbit's surgical area was shaved, disinfected with iodophor, and both ovaries of the female rabbit were surgically removed. Three days before the operation, the bone density (BMD) of the lumbar spine was measured with an X-ray bone densitometer (GE Company, USA). Four months after the operation, the BMD of the lumbar spine and proximal femur was measured again with an X-ray bone densitometer. An animal model of osteoporosis was successfully established. The criterion for successful modeling is that the mean BMD of all animals is lower than the mean before castration minus 2.0SD.

3. After confirming that the modeling was successful, 60 osteoporotic rabbits were randomly divided into 6 groups, namely the blank control group (Group A, no vibration stimulation), the positive control group (Group B, using 30Hz regular sinusoidal vibration), Complete random vibration group (Group C), simulated jogging group (Group D), simulated fast running group (Group E), simulated rope skipping group (Group F). Among them, groups C-F correspond to the vibration modes shown in Figures 8, 10 and 12 respectively. The animals in groups B-F were fixed on the rabbit table and received vibration treatment at the lumbar spine. Each vibration lasted for 33 minutes, once a day, for 3 months. There are 10 animals in each group. All animals are fed a fixed amount (200g/d), drink water freely, and are kept at a temperature of 20 to 25°C and a relative humidity of 40% to 70%.

4. After 3 months of vibration treatment, each sample in the control group and each experimental group was killed by air embolization of the marginal ear vein, the right distal femur was isolated, and 10 specimens from each group were placed into Micro-CT (GE-LSPmicro -CT, GE Company of the United States) sample cup, scan under the same conditions (44mL tube-21μm-150mins, threshold: 1044), determine BMD and bone mineral content (BMC), and analyze the number, thickness, and connection density of trabeculae. , and bone volume ratio and other trabecular bone stereometry indicators.

5. Statistical processing. Data are expressed as mean ± standard deviation Expressed, SPSS11.0 statistical software was used for analysis of variance and LSD-t test.

Experimental results and analysis

1. Results of establishment of osteoporosis animal model

Compare the mean BMD of all animals before castration and the mean BMD of all animals after castration. The results are shown in Table 1. The results in Table 1 show that the BMD of the rabbit's lumbar spine and proximal femur decreased significantly after castration, and the difference from the BMD before castration was statistically significant (P<0.05), indicating that the modeling was successful.

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

Measurement time lumbar spine proximal femur before castration 292±28 289±35 After castration 179±21 182±37

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

Table 2 records 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 B-F are significantly higher than those in group A, which is statistically significant. difference. There is no statistical significance in BMD between groups B and C-F, and between C-F. However, the value of random vibration group C-F is higher than that of group B. In terms of BMC, there is no statistical difference between C-F, but they The difference with group B was statistically significant. This shows that the random vibration mode of the present invention can achieve an effect of increasing bone density that is not inferior to that of the traditional periodic frequency conversion mode, and can better increase the bone mineral content of osteoporosis subjects.

Table 2 BMD and BMC results of distal femur

The trabecular bone indexes of the distal femur of animals in each group were measured, and the results obtained are shown in Table 3. The results in Table 3 show that the differences in various detection indicators between group A and groups B-F are statistically significant. Among them, the difference in BV/TV and trabecular bone connection density test results between groups B and C-F was statistically significant. The test results of TB.N, Tb.Sp and Tb.Th in group C-F were all higher than those in group B. In some cases, In the random vibration group, the differences in TB.N and Tb.Sp were also statistically significant compared with group B. Trabecular bone is the most active component of bone metabolism because it is close to the bone marrow space. However, trabecular bone is also extremely susceptible to local or systemic disturbance factors, leading to bone metabolism imbalance. The random vibration method of the present invention is different from traditional Compared with other methods, it can better promote the growth of trabecular bone and inhibit bone imbalance.

Table 3 Results of stereometric indexes of distal femoral trabecular bone

Effect Example 2: Therapeutic effect of random bionic vibration device on osteoporosis in menopausal women

Through volunteer recruitment, we selected 60 menopausal transition and early menopausal women who met the criteria for osteoporosis with an average age of 49.43±3.43 years old (age distribution 43-58 years old) and used a similar pilot study to randomly select them. Divide into 3 groups, two groups are the random bionic vibration group, use the random bionic vibration device shown in Figure 20 of the present invention for vibration treatment, and the other group is the control group. The random bionic vibration group applied random vibration in the frequency range of 30 to 50 Hz to the human body to observe the clinical effect of vibration on bone loss. The subjects were divided into vibration groups A1 to A2 and control group B. Group A1 adopts the completely random vibration mode in Figure 5-6, and Group A2 adopts the simulated rope skipping mode in Figure 11-12.

According to the expected treatment plan, a course of treatment lasts for 6 months, with vibration therapy performed 5 times a week, each treatment lasting 30 minutes.

Heart rate and blood pressure watches were issued to the research subjects in groups A1-A2, and the subjects' blood pressure and heart rate were measured and recorded before and after each treatment. The subjects in each research group were instructed to keep their original living habits unchanged. Before and after treatment, the bone density of the whole body, lumbar vertebrae 2-4, and femoral neck of the study subjects was measured.

Statistical analysis was performed using SAS (version 9.2). A paired sample t test was used to compare the bone density of the subjects in the vibration group before and after intervention and the subjects in the control group before and after follow-up. Two independent samples t test was used to compare the bone density changes of the subjects in the vibration group and the control group before and after vibration/follow-up.

The inspection equipment is DEXA bone density detector (bone densitometer).

The research is still in progress. In the preliminary spot check of bone density for 3 months, it can be observed that the bone density of the subjects in the vibration group decreases more slowly than that of the subjects in the control group, which can confirm the randomness of the present invention. Bionic vibration device has the effect of treating osteoporosis.

Claims (10)

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.