STOCHASTIC TYPE

Background of the invention

The present invention relates to a method for controlling vibration equipment, wherein the vibration equipment has a vibration device which is configured to be brought in contact with at least one body part of a human being or an animal, the body part having at least one reduced or absent function, and wherein the vibration equipment is by means of at least one vibrator included therein configured to cause that the body part is subjected to vibration in order to stimulate the body function, as stated in the preamble of claim 1.

In addition, the invention relates to a device for influencing at least one reduced or absent body function on at least one body part of a human being or an animal, wherein the body part by means of at least one vibrator in the vibration device is subjected to vibration in order to stimulate the body function, as stated in the preamble of claim 11.

Discussion of prior art

In the human body there are three "systems" which involve neuromuscular control (also named sensomotoric control).

One system is the eyesight system, and another is the vestibularis system in the inner ear. The third one is the proprioceptive system, which consists of mechano-receptors in muscles, tendons, ligaments, capsula articularis, skin and sub-skin tissue.

US 5, 101,810A discloses vibration equipment in the form of a chair or a bench in contact with a person, the body being exposed to low frequency acoustic sound/ vibration signals simultaneously with supplying music to the ears of the person, and a component of the music is superimposed onto said low frequency signal. The patent discloses observable positive stimulant in connection with Rett's syndrome, autism, spastic conditions, neck or shoulder pain, lumbago, pre-menstrual pain, asthma, stress-inflicted depression, sport injuries, rheumatism, muscular spasms and general discomfort upon a state of tension. Equipment of this type or corresponding types can, however, upon such influence not be able to stimulate muscle spools and/or tendon spools to a degree worth mentioning. Muscle-/ tendon spools have as a task to signal to the brain the state at any time which the muscular fibers are in, i.e. relaxed, statically contracted, dynamic activity, or whether the muscular fibers are stretched.

The previous inventions of the applicant as described inter alia in EP 1,819,405-B1 and US 2010/0063426-A1 (=N0325,834) disclose vibrations equipment for influencing the proprioceptive system of the body, wherein the equipment with selected vibration frequencies is capable of setting into vibration during specific time periods depending ropes which lowermost are engaging and are loaded by a body part of a person. By means of such equipment there is provided a method known as Redcord® Neurac®, wherein it is aimed at optimal activation of muscle spools by using body weight as resistance (heavier and heavier) and then supply mechanical vibration to the musculature in order to enhance feedback from muscle spools to the brain via the spinal marrow. This in turn leads to increased signal activity from the brain to the muscle fibers via the nerve paths (tractus). Sensational results of treatment from using such equipment have been achieved in connection inter alia with whiplash-injuries, joints having pain and poor mobility and back discomfort, including discus prolapse and ischias.

Objects of the invention

However, the applicant has observed that for certain ailments, as e.g. with patients having great movement inhibitions, unbalance or dizziness, often in conjunction with intensive pain, a strong demand for further to challenge and stimulate the proprioceptive system seems to be present.

The present invention has therefore as a task to provide a solution by which such demands are remedied.

Summary of the invention

According to the method of the invention, it is characterized by signal controlling said at least one vibrator to produce vibration of stochastic type having at least one frequency, at least one amplitude and at least one defined vibration cycle as parameters, at least one of the parameters having a parameter value selected from one of: stochastically selected value and stochastically varying value.

By the term stochastic is understood here and in the following that the vibration and its at least two parameter values have not pre-determined characteristics and are thus arbitrary or "randomized"

According to an embodiment of the method the signal control of the vibration control of said at least one vibrator exhibits one property feature, i.e. one operational mode, from at least two of the following features a) - c):

a) al) causing current vibration frequency to be elected selectively or arbitrarily from the vibration range 15 - 150 Hz , or a2) electing at least two mutually different vibration frequencies from the range 15 - 150 Hz to selectively or arbitrarily appear simultaneously,

b) bl) causing duration of the vibration to vary arbitrarily from 0.5 to 10 seconds, preferably 0.5 - 5 seconds, or b2) causing duration of the vibration to vary arbitrarily in constant intervals of elected duration from 0.5 to 10 seconds, preferably 0.5 - 5 seconds,

c) cl) causing the intervals between the vibrations to vary arbitrarily from 1 to 10

seconds, preferably 1 - 5 seconds, or c2) causing the intervals between the vibrations to vary in a predetermined manner from 1 to 10 seconds, preferably 1 - 5 seconds.

When the signal control comprises at least feature al), the signal control may in addition, upon an elected, supplementary operational mode dl), cause the vibration to jump as regards duration or frequency and to be superimposed on or be co-operative with stochastic noise.

When the signal control comprises at least feature a2), the signal control may in addition, upon an elected, supplementary operational mode d2), cause the vibrations having different frequencies to jump as regards duration or frequency/frequencies and to be superimposed on or be co-operative with stochastic noise.

When the signal control comprises at least feature al), the signal control may in addition, upon an elected, supplementary operational mode el), cause the vibration strength of selectively or stochastically elected frequency to be changed from vibration interval to vibration interval.

When the signal control comprises at least feature a2), the signal control may in addition, upon an elected, supplementary operational mode e2), cause the vibration strength or respective vibration strength of the selectively or stochastically elected frequencies to be changed from vibration interval to vibration interval.

When the signal control comprises at least feature al), the signal control may in addition, upon an elected, supplementary operational mode fl), cause the vibration strength of selectively or stochastically elected frequency to be changed steadily or stochastically during the course of a vibration interval.

When the signal control comprises at least feature a2), the signal control may in addition, upon an elected, supplementary operational mode f2), cause the vibration strength or respective vibration strength of the selectively or stochastically elected frequencies to be changed steadily or stochastically during the course of a vibration interval.

In a further embodiment of the method, the signal control will upon election of another supplementary operational mode g) cause that the vibrator delivers, stochastically or at predetermined different times, vibration stimuli or vibration stimuli in co-operation with stochastic noise.

According to still another embodiment of the method, the vibration of stochastic type will by means of the signal control, upon election of another supplementary operational mode h) be caused to co-operate with a vibration having a constant low frequency in the range 5 - 60 Hz, preferably 10 - 20 Hz.

According to the invention, there is provided a device of the type mentioned in the introduction and which is characterized in that the vibration device is configured by means of said at least one vibrator to deliver vibration of stochastic type with at least one frequency, at least one amplitude and at one defined vibration cycle as parameters, at least one of the parameters having a parameter value elected from one of: stochastically elected value and stochastically varying value. Further embodiments of the vibration device are found in the attached patent claims 12 - 23, the claims 12 - 22 their contents being related to the contents of the attached method claims 2 - 10, respectively.

As indicated in claim 22, the vibration device is preferably configured to deliver said supply of vibration to the current body part or current body parts when the body part(s) are subjected to static or dynamic loading.

In a preferred embodiment, as stated in claim 23, but which is not in any way to be considered as limiting for the use of the vibration device, the vibration device is locatable at elected distance from a current body part, as it is designed for co-operation with a training or exercise apparatus which has a pair of depending ropes of adjustable length, the ropes lowermost being designed to co-operate with at least one body part of said human being or animal, and wherein the vibration device has a housing which at either end region has means for selective, releasable attachment to one of the ropes or to both of the ropes, respectively.

Background of stochastic noise or vibration and stochastic resonance, and with reference to the invention

Even though stochastic noise (or stochastic vibration) and "stochastic resonance" SR are terms which have existed for many decades, still the use of stochastic noise has not led to practical equipment on the market for use in alleviating physical ailments of human beings or animals, and most of that which is described in literature is related only to tests of laboratory type. SR was in fact discovered and proposed for the first time in 1981 in order to explain periodic re-appearance of ice ages.

The term "stochastic resonance" SR is in the context related to human beings or animals a mechanism or phenomenon which appears because it is added noise, e.g. vibration, as extra stimuli to reach thresholds for firing nerve cells, with the purpose of stimulating functions which have become inactive or do not react in a normal way. SR, per definition, is a nonlinear phenomenon where addition of an arbitrary disturbance (noise) may improve detection of weak stimuli or enhance information contents in a signal, e.g. train of action potentials or signals generated by neuronal composition. An optimal amount of supplied noise yields maximum improvement, whereas further increases in noise intensity only degrades detectability or information contents. It is therefore interesting and important to note that too high intensity of stochastic noise (vibration) most often causes deteriorated sensomotoric signal. Correct level is therefore important. The SR effect appears to have an almost Gaussian characteristic, where too low vibration level or too high vibration level does not provide optimal results. For persons having no specific ailment in a body part, influence of stochastic noise will in some cases give negative effects or have no effect because the transportation of signals is normal.

SR may in individual cases appear even with sinusoidal vibration, i.e. vibration with fixed amplitude and steady vibration, but in the present invention it has been found that stochastic noise in the form of vibration, i.e. e.g. vibration with arbitrary amplitude and uneven vibration cycle, or randomized vibration where frequency, amplitude, vibration time and/ or cycle varies in an undefined pattern provides well-defined extra stimulant. The preliminary test results from tests done on a closed group patients having different ailments exhibit sensational treatment results which no type of medication based treatment or traditional physiotherapy treatment yet has been able to exhibit. The interesting aspect of the treatments which are performed seems to indicate that the treatment provides a long term or permanent, positive result. Inter alia, a young man being very handicapped and a wheelchair user, has subsequent to a limited number of treatments regained full walking function. The treatment results are in a process of being systemized and will be further disclosed later.

Tests having been made by the applicant, inter alia tongue tests, exhibit remarkable results before and after treatment, and in using MR measurements it can clearly be observed increased brain activity and shifting of activity centers in the brain. This may indicate that the brain, when conceiving specific stimuli, is capable of reorganizing in order to open signal paths and establish other signal paths or control programs, in order to thereby control body parts which are not optimally influenced.

SR is extensively described in the literature and the reactions which appear are clearly observable, although it is not fully appreciated which mechanisms that are involved and how they co-operate. Research which has been carried out indicates that in order to "cheat" the brain to initiate reactions, it is important that inter alia at least one vibration parameter varies or appears in an arbitrarily or unpredictable pattern. Even though stochastic noise or stochastic resonance are term which have existed for over 40 years, the use of stochastic noise has still not led to practical devices on the market to be used to remedy physical ailments in human beings or animals.

In the literature there is disclosed that tests performed in a simple manner and to a limited extent have shown that stochastic noise has SR effect in multiple situations, inter alia to prevent tendency to falling (important to prevent femur neck fracture), remedy instability and dizziness of elderly people or patients suffering from diabetes, posture swaying of such people and patients having had a stroke. In such cases, there has during tests been used a stochastically vibratory platform, vibrators attached to ankle portions or below the foot sole, and also auditory noise signals and stimulants by means of electrodes attached to the rear side of the ears.

Patients, in particular elderly who get vibrations (subsensory noise) applied to their feet, obtain significantly better balance and less tendency of swaying and instability, even when standing on one leg. A corresponding tendency is also observed as regards ankle instability, where use of stochastic noise- stimulant results in stochastic resonance and improved stability. US 2008/161734-A1, US2011/271554-A1, US2012/186101-A1 and US2012/222333-A1 disclose some examples of vibratory insoles. Among other aspects when using stochastic noise can be mentioned that tests, disclosed in the literature, have indicated that a certain level of background noise or "white noise" have positive effect on memory properties and ability of apprehension related to inattentive children, in particular children with ADHD. Such children are often more easily distracted than other children during otherwise normal circumstances. The effect is also somewhat dependent on the individual: External noise (noise outside the nervous system) and internal noise (neural noise - related to dopamine-tone). If reduced or damaged dopamine transfer is present, then external noise seems to provide beneficial effect (ADHD). Even though beneficial as regards ADHD, corresponding noise applied to those having normal attention/ ability of comprehension may be harmful. Positive observations have also been found with patients having dopamine-related neurodegenerative disturbances, such as akinesia, Parkinson and aging. Dopamine seems to modulate the effect of noise. Studies in this connection have been made at Lund University Cognitive Science, Sweden by Sikstrom, Soderlund and Smart. In particular task-irrelevant noise has been found to provide effect, e.g. traffic noise.

Stochastic noise (randomized noise) seems to provide positive results. The noise contributes to raising a signal which is below auditory threshold, and the signal thereby becomes detectable. Too low or too strong noise level will not necessarily provide result, but in certain cases attenuate the signal. Such use of stochastic noise may e.g. be used to improve hearing for persons having reduced hearing or have cochlea implant. The basic concept is that multiple sources of unpredictable variability in fibers in the hearing nerve in case of normal hearing is known to be absent in deaf ears. The hypothesis is therefore that a finely controlled, arbitrary component in the feed-out of cochlea implant electrical signals may stimulate nerve fibers in a more natural way and which can lead to improved hearing.

The FASEB Journal express article 10.1096, 3. Dec.2002 indicates that application of vibration of low magnitude to a large degree improved formation of bone as a reaction to loading, which may indicate that stochastic resonance can contribute to osteogenic reaction. Journal of wound care vol. 19, no 3, March 2010 indicates that stochastic "white noise" which was applied to ulcus pepticum (which is difficult to heal) during 60 consecutive days, reduced the surface area of said ulcus pepticum by a total average closing rate of 82.5%

Journal Appl. Physiology 2008, October 107(4) = 1017-1027 discloses that stochastic mechano-sensoric stimulation may stabilize immature respiratory patterns of pre-maturely born children, inter alia apnea and hypoxia.

Another interesting study is how stochastic noise influences a living creature is e.g. the observation a so-called "paddlefish" (polyodon spathula) in a swimming mill between two parallel plate electrodes which emit a noise field with a frequency 0,5 - 20 Hz. In this case, the fish managed to detect considerably more food than without such a noise field present. Stochastic phenomena in the body therefore seem to have greater importance that what has been known before, and that stochastic resonance may have importance both as regards development of illness and healing functions. SR therefore seems clearly to have importance for intercell-communication.

The Development of a noisy brain. Mcintosh, Kovacevic, Lippe, Garrett, Grady; Jirsa— Archives Italiennes de Biologie, 148: 323-337, 2010) concludes by indicating that the maturing changes in brain noise represents the improvement of functional network potential, i.e. the dynamic repertoire.

Testing of noise in human muscle spools indicates the possibility that fusimotor-systems use a stochastic resonance-type mechanism in order to increase the sensitivity of muscle spools to stretch. It is known that fusimotor activity and muscle spool output is improved in the course of postural tasks and new movements.

The Effects of Stochastic Resonance Stimulation on Spine Proprioception and Postural Contol in Chronic Low Back Patients (Reeves, Cholewicki, Lee og Mysliwiec , Spine, vol. 34, no.4, pp.316-21, 2009), states that test results show that SR stimulation of paraspinal muscles improves posture control, but this improvement can hardly be credited to improved spinal proprioception. Persons with compromised neuro-muscular control or those subjected to instable environments may have benefits from SR-stimulation.

Wikipedia discloses that stochastic resonance has been observed in the neural tissue in sensory systems of multiple organisms. SR has yet to be explained completely as regards biological systems, but neural synchronism in the brain (in particular in Gamma wave frequency) has been proposed as a possible neural mechanism for SR by researchers which have investigated "sub-conscious" visual experience.

In using the method and the vibration device according to the invention, vibrator(s) of a type as e.g. described in the applicant's US publication 2010/0063426-A1 (=NO 325834) may be used. It is one currently used type.

The invention is now to be more closely explained with reference to the attached drawing figures, these figures illustrating non-limiting embodiments of the device according to the invention. Brief description of drawings

Fig. 1 shows a simplified principle block schematic of a vibration device, according to the invention.

Figs. 2 and 3 show non-limiting uses of the vibration device, according to the invention.

Fig 4 illustrates remote control option and position shifting of the vibration device, according to the invention.

Fig.5a and 5b show known vibration equipment, according to the previous invention by the applicant, as shown inter alia in US 2010/0063426-A1, as seen in frontal view and from above, respectively. Detailed description of the invention

As mentioned in the introduction it is through the inventive ideas and testing found that the present method and vibration device provides possibility for improved results of treatment of ailments which are not easily cured by means of known medication, surgery and/or traditional physiotherapeutic treatment. As mentioned some ailments are treatable in a good manner using method and equipment of Redcord® Neurac®, as inter alia disclosed in US

2010/0063426-A1.

The present invention has as outset been tested with particularly good and from medical view highly interesting and sensational results by using vibration equipment in the form of a vibration device configured as a vibration beam 1 which with its housing Γ is suspended between a pair of ropes 2, 3 extending from a training/exercise apparatus 4 known as

"Redcord® Trainer" by means of which the length of the ropes depending therefrom is easily adjustable. The ropes 2, 3 may lowermost end in e.g. gripping straps 5, 6 as shown on Fig. 2 or be attached by means of gripping pieces 7 to a sling 8 via sling straps 8', as shown on Fig. 3.

Even though the invention in an embodiment is specifically referred to in using the vibration beam together with a pair of ropes, it will be appreciated that the invention is in no way limited to such a use, and that another type of equipment to transfer vibrations to a human being or an animal using the means (method and vibration device) which the invention are directed to, will lie within the scope of the invention, and which an expert in the art through guidance from the invention may put to practice.

The vibration beam 1 is attachable to the ropes 2, 3 in releasable manner through use of gripping devices 9, 10. In a currently preferred embodiment of the gripping devices they each consist of three locking studs 9', 9", 9"' and 10', 10", 10"' which the ropes are passed by in a wavy pattern and thereby attaches the beam 1 to the ropes 2, 3. This is shown in a somewhat enlarged view on Figs. 5a and 5b. In this manner, the vibration beam 1 may be attached at a required location along the length of the ropes, so that there is a specific distance L from the base 11 on which a person 12 lies, e.g. on a bench for treatment. The chosen distance L will also be decisive for the fraction of vibration energy, from the vibration beam 1 and transferred to the ropes 2, 3, which will reach the person 12. The larger the value of L, the lesser the energy transfer.

As shown on Fig. 5a, the vibration beam 1 has a housing 1' and inside it there is located, as previously known from US 2010/0063426-A1, three vibrators in the form of electric motors 13, 14, 15 which are configured via their rotary shaft to move associated rotary, eccentrically supported weights 13', 13"; 14', 14"; 15', 15". An on/off switch 16 for power supply 17 is located on the housing 1'. The vibration beam 1 may e.g. be provided with display panels 18, 20 which in the known embodiment shows e.g. frequency and duration, respectively, and where election options are controlled by election buttons 19, 21. Intensity settings can e.g. be controlled by means of an election button 22 which may also control how many of the vibrators inside the housing of the vibration beam are to operate simultaneously. These display panels and election buttons are in the context of the present invention only examples, as it is possible to visualize that the display panels instead show the elected operation modes, i.e elected from the election options: al, a2; bl, b2; cl,c2; dl, d2; el, e2; fl, f2; g; h, and that it will be sufficient with one display panel 24, e.g. of "touch screen" type.

If the vibration beam 1 provides possibility for remote control from a remote control unit 23, the remote control unit may have a display 23' displaying the elected vibration modes. Whether these chosen vibration modes are shown in clear-text, graphics or in codes is immaterial relative to the contents of the invention. Transfer of control signals from the remote control unit 23 to the vibrator in the vibration beam 1 should be wireless, even though in some cases it may be realistic or desirable to have cabled transfer.

Alternatively, the remote control 23 may, instead of a customized device, e.g. consist of a PC, a lap-top, a network-pad or a smart-phone. The advantage is a simpler up-grading of software which is to control the vibrator. A power amplifier is normally required to provide sufficient signal power to the vibrator, e.g. when it is of traditional type as shown and explained in connection with Figs. 5a and 5b. The signal unit 25 and the election options are not drawn on Fig. 5a for the sake of clarity. As shown on Fig. 1 there are multiple election options, all dependent on the type of treatment which is desirable to be carried out in order to obtain a best possible result of treatment. For a particular patient it may be realistic using not only one type of treatment as regards vibration mode, but rather successive treatments of different type.

As mentioned in the introduction it is important that the vibration equipment, the vibration beam 1, the ropes 2, 3 and the straps 5, 6 or the sling 8, 8' as in the example, is configured to interact with at least one body part of a human being or animal. When the body part in this manner interacts with the vibration equipment and is subjected to vibration, there is present a possibility to stimulate the body function.

The method and the vibration device, according to the invention, is related to provide vibration of stochastic type with at least one frequency, at least one amplitude, and at least one defined vibration cycle as parameters, at least one of the parameters having a parameter value elected from: stochastically elected value and stochastically varying value.

The signal control output from the signal unit 25 for vibration control of said at least one vibrator exhibits one property feature, i.e. one operational mode, from at least two of the following features a) - c):

a) al) causing current vibration frequency to be elected selectively or arbitrarily from the vibration range 15 - 150 Hz , or a2) electing at least two mutually different vibration frequencies from the range 15 - 150 Hz to selectively or arbitrarily appear simultaneously,

b) bl) causing duration of the vibration to vary arbitrarily from 0.5 to 10 seconds, preferably 0.5 - 5 seconds, or

b2) causing duration of the vibration to vary arbitrarily in constant intervals of elected duration from 0.5 to 10 seconds, preferably 0.5 - 5 seconds,

c) cl) causing the intervals between the vibrations to vary arbitrarily from 1 to 10

seconds, preferably 1 - 5 seconds, or

c2) causing the intervals between the vibrations to vary in a predetermined manner from 1 to 10 seconds, preferably 1 - 5 seconds.

When the signal control comprises at least feature al), the signal unit 25 may in addition, according to an elected, supplementary operational mode dl), cause the vibration to jump as regards duration or frequency and to be superimposed on or be co-operative with stochastic noise.

When the signal control comprises at least feature a2), the signal unit 25 may in addition, according to an elected, supplementary operational mode d2), cause the vibrations having different frequencies to jump as regards duration or frequency/frequencies and to be superimposed on or be co-operative with stochastic noise.

When the signal control comprises at least feature al), the signal unit 25 may in addition, according to an elected, supplementary operational mode el), cause the vibration strength of selectively or stochastically elected frequency to be changed from vibration interval to vibration interval.

When the signal control comprises at least feature a2), the signal unit 25 may in addition, according to an elected, supplementary operational mode e2), cause the vibration strength or respective vibration strength of the selectively or stochastically elected frequencies to be changed from vibration interval to vibration interval.

When the signal control exhibits at least feature al), the signal unit 25 may in addition, upon an elected, supplementary operational mode fl), cause the vibration strength of selectively or stochastically elected frequency to be changed steadily or stochastically during the course of a vibration interval.

When the signal control exhibits at least feature a2), the signal unit 25 may in addition, upon an elected, supplementary operational mode f2), cause the vibration strength or respective vibration strength of the selectively or stochastically elected frequencies to be changed steadily or stochastically during the course of a vibration interval.

Within the scope of the present invention there is the possibility that the signal unit 25, according to any elected operational mode(s), upon election of another supplementary operational mode g) may cause that the vibration device delivers, stochastically or at predetermined different times, vibration stimuli or vibration stimuli in co-operation with stochastic noise. There is also a possibility, within the scope and concepts of the invention, to let the signal unit 25, suitably a microprocessor, according to any elected operation mode(s), upon election of another supplementary operational mode h), cause the vibration of stochastic type to cooperate with a vibration having a constant low frequency in the range 5 - 60 Hz, preferably 10 - 20 Hz.

It will be appreciated that in using a device according to the invention, it is possible to apply to one body part stochastically or at predetermined different times, vibration stimulants or vibration stimulants in co-operation with stochastic noise. However, the device may also be configured to apply simultaneously to a plurality of body part stochastically or at predetermined different times, vibration stimulants or vibration stimulants in co-operation with stochastic noise.

It has also been discovered that best treatment effects are achieved if the device is configured to deliver said application to the body part(s) in question when the body part(s) are subjected to static or dynamic loading.

Even though the invention has been shown and described in relationship to usage with a vibration beam 1 which influences a pair of ropes, it is within the scope of the invention to be able to influence one or more body parts with vibration equipment of another type than the one which is shown and described here, as long as the criteria according to the claims 1 - 22 are met. Even though there is described a currently useable type of vibrator, it will be appreciated that other, similar and suitable types of vibrators may be used, also types which are already commercially available.