MANDOLESI DIMITRI (IT)
MANDOLESI DIMITRI (IT)
| WO2002094171A1 | 2002-11-28 |
| US20040153009A1 | 2004-08-05 | |||
| US20060030907A1 | 2006-02-09 | |||
| US20050267388A1 | 2005-12-01 |
CLAIMS
1. The main claim is the synchronous or asynchronous frequency and/or pressure variation, in all possible combinations, of the acoustic pressure wave emitted by the Pain Relief Acoustic Device (PRAD), i.e.: • the apparatus can emit in a synchronic way a fixed wave frequency and pressure that can be suddenly and simultaneously increased or decreased (almost immediate decrease for instance from 100 up to 1 Hz and from 5 up to 0.01 Bar, or increase from 25 up to 150 Hz and from 1 up to 6 Bar) (Fig. 1).
• Sudden variations can be consecutive with or without intervals (continuous or pulse system), with possible increase or decrease of frequency and pressure (Fig.
2).
• During the intervals between variations it is possible to reset frequency and pressure to initial emission values.
• The apparatus can emit frequency and pressure in an asynchronic way, so that sudden frequency variation can take place before and/or after the pressure one, with repeated or inverted cycles (one cycle consisting of frequency variation followed by pressure variation and the following cycle consisting of pressure variation followed by frequency variation. A cycle can consist of a single wave train or of several wave trains, either using continuous or pulse system) (Fig. 3). • Frequency and pressure emission can be increased or decreased simultaneously to pressure increase or decrease either using the continuous or pulse system (Fig. 4),
2. As claimed in claim N° 1 other possible variations can be emitted either by a single probe or by two or more ones forming a single probe or operating individually. The probes can emit acoustic pressure waves having the same frequency and pressure or with all variations as afore mentioned and any possible combination thereof, in a synchronic or asynchronic way for the different probes Fig. 5
3. Resolution of acute or chronic pain by the use of frequency and pressure modulated acoustic pressure waves ranging from 1 (min) up to 500 Hertz (max) and from 0.001 (min) up to 8 Bar (max).
4. Manual setting for sudden and simultaneous frequency and pressure increasing or decreasing of acoustic pressure waves consisting of a rotating and/or coming and going movement on the area to be treated suddenly pushing and lifting the probe.
5. Acoustic pressure wave generation and modulation system (frequency and pressure variation) obtained using either the engine or compressors or systems conceived to this purpose (Fig. 7).
6. Pneumatic and/or electronic or other system in order to modulate pressure and frequency (Fig. 8)
7. Programmable or auto-setting system to set frequency and pressure variation of acoustic pressure waves
8. Device (manual or automatic) application method, supposing the preliminary drawing up of a paper or digital myofunctional map illustrating body points to be submitted to treatment by the PRAD. The myofunctional map is drawn up after hand or device examination of patient's muscular apparatus; in this latter case, the device should be used in diagnostic mode. The myofunctional map is drawn up utilizing a specific symbology (Fig. 9).
9. Software for the drawing up of the myofunctional map allowing map filing and data analysis
10. The use of the device is mainly conceived to attain the resolution of acute or chronic pain in humans or animals
11. The use of the PRAD in case of acute and/or chronic pain resistant to physio-, surgical of pharmaco-therapy The use of the PRAD in treating lipedema, edematous-fibrosclerotic panniculopathy
(cellulitis) and lymphedema of any origin. |
TITLE
Pain Relief Acoustic Device
DESCRIPTION
Technical Field People have sought relief from pain for centuries. While many pharmaceutical compositions have proved quite successful, continued use of many medications leads to adverse side effects. Narcotic pharmaceuticals impair patient functioning and can be addictive.
Moreover, many patients are not suitable candidates for pharmaceutical intervention. Pregnant women are advised to avoid most medications. Patients with allergic or gastric problems are prohibited from taking many pain relieving pharmaceuticals. Patients under care with other medications for different medical conditions, suffer from drug interactions. Many medications must be ingested, which can be quite problematic for people with swallowing difficulty.
Disclosure of Invention
The present invention consists of a device and system giving pain relief in a few minutes by direct stimulation on muscles where fibres are subject to continuous contractures.
Acoustic pressure waves are characterized by some essential parameters: the wave pressure is proportional to the energy and it is in relation with pressure variations. The frequency is also proportional to the energy, but is connected with the number of width peaks per time unit.
The Pain Relief Acoustic Device (PRAD) is a frequency and pressure modulated apparatus. It consists of a specific acoustic pulse generator; pulses are transmitted to the tissues in an atraumatic way by skin contact using a small resonance cup, reducing or even resolving pain in a few minutes.
The main feature of the invention is the synchronous or asynchronous frequency and/or pressure variation, in all possible combinations, of the acoustic pressure wave emitted by the PRAD.
The use of the device can be either manual or automatic. The device is composed of a pressure wave generator ranging from 1 (min) up to 500 Hertz (max) and from 0.001 (min) up to 8 Bar (max).
It is usually almost impossible to relieve chronic pain even after several years' treatment.
PRAD is an innovative apparatus whose technology is particularly conceived for those patients, no responders, who, so far, have no therapeutic perspectives.
An irritating physical disease can considerably worsen life, sometimes leading also to psychic depression.
The PRAD allows to a great extent to get rid of pain, even in the case of diseases resistant to usual analgesics and lasting from years.
A single treatment is sufficient to predict whether the treatment is effective; in fact, after a few minutes of treatment, if the interested area is no more painful or only a residual pain can be felt, it is possible to sentence that in almost all cases the successive treatments will bring to the resolution of the pain.
Pain affects posture (antalgic posture), and this situation, if long lasting, would also cause physical alterations to body areas far from the onset point due to work overload.
Pain relief, in addition to restoring psychic wellbeing, allows the patient to start again practising the appropriate motor activity required to attain such a physical form as to get permanent results thereby increasing his self-esteem.
PRAD treatment has the following features: is uninvasive is immediately effective does not involve current emission can be repeated if required ° is not operator dependent does not transfer drugs or uses contact fluids does not burn the skin does not use magnetic fields or laser ° is delivered in a short time (approx. half an hour).
The action mechanism of the PRAD, supposed on the basis of its rapid effect on pain, is the functional reactivation of muscle fibres suffering from contracture. The fibres, being in a contraction status, cannot be no longer regulated by the muscle spindle system and may remain in such status also for years.
The neuromuscular spindle, morphologically identified as a sense organ in 1893 by Ruffini and Kerschner, is a highly specialised structure widely spread in skeletal muscle parenchyma. It consists of a muscular fibres fascicle dedicated in gathering data on muscle length and tone, approx. 10 mm long, which is enclosed in a spindle-shaped connective capsule. It is a particular mechanic receptor situated inside human body striated muscle, arrayed parallel and strictly connected with muscle fibres and sensitive to minimal mechanic stimulus of the order of 3 grams.
Clinical Background
Some of the most frequent painful pathologies which can be treated using PRAD are the following: • Diseases resistant to pharmacotherapy, i.e. diseases unresponsive to therapies by ordinary anti-inflammatories, analgesics, muscle relaxants and cortisone;
• Diseases non-decreasing after surgical treatment, such as slipped disc, hip or knee prosthesis, arthroscopic shoulder or knee operations, etc.;
• Post operative diseases occurring after standard rehabilitation post operative treatments and after physio- and massotherapy treatments where no appreciable benefits have been recorded;
• Pains after sport traumas such as pubalgia, or injuries to deep muscles, i.e. iliopsoas, obturator, pyriform, popliteus which have stopped several times athletes during their career resulting in such a persistent pain as to prevent their sport activity;
• Pains caused by arthritis in the cervical, dorsal, lumbar regions as well as in upper and lower limbs, well known to older people and painful to the point they can be no more self sufficient. It means those people, even young, who having been suffering from these pathologies, are definitely persuaded there is nothing to do against pain and have resigned to a painful existence;
• Periarthritis humero-scapularis pains not significantly affected by usual therapies and often submitted to surgical treatment;
• Radial epicondylitis, one of the more disabling pathologies to workers, affecting the elbow of the dominant arm and practically preventing the patient from the usual working and leaving activities;
• Muscle diseases caused by postural imbalance, i.e. pains originating far from the painful point due to blocks of the articular movements and which, through myo-fascial kinetic chains, are felt in areas far from the block itself;
• Muscle tension headache. Diagnosis of contractures at head level needs an accurate examination and the drawing up of a myofunctional map in order to select the adequate therapy; to our experience, this system has been successful in treatment of headache lasting from several years;
• Psychosomatic pains (to a lower or higher extent all kinds of pain which can be submitted to this treatment); the PRAD treatment generates a somato psychic effect producing in most cases the readjustment of patient typical emotional tensions;
• Pains in lower limbs in patients suffering from chronic venous insufficiency (varix) possibly associated with feeling of weight, restless leg syndrome, burning and cramps;
• Women painful intercourse (dyspareunia).
Usually the PRAD can treat successfully pains not associated with tissue inflammation either traumatic or infective or allergic, therefore when neither tissue swelling nor redness or heat are present in the painful area. Clinical effects
During the past years a significant amount of treatments have been delivered. In most patients successful results have been recorded after only four treatments, delivered once a week. Considering the specific efficiency in muscle-bone pains, the use of the PRAD, in other fields of human pathologies, is to be further investigated.
Background Art
Based on a research on devices utilizing acoustic waves, the following apparatuses have been identified:
1. (wo/2005/117797) method and apparatus for relief of headache 2. (wo/2006/061867) apparatus and method for the conditioning of muscular fibrils reaction coordination capacity by biomechanical stimulation
3. (wo/2003/075758) system for instant diagnosis and treatment of soft tissue disorders
4. (wo/1998/033171) method and device for producing shock waves for technical and specially medico-technical applications
5. (wo/2006/118608) therapeutic micro-vibration device
Item (1) above is an apparatus designed to treat only headache instead of all types of pain. It utilizes vibrations transmitted by a microphone to the patient's head cutis producing micro-oscillations of a minimal pressure. Basically it does not use synchronous and/or asynchronous frequency or pressure variation of acoustic pressure wave (during session).
Item (2) is aimed at increasing muscle strength by muscle fibres functional recruitment. It utilizes several transducers, placed on muscle groups to be treated, and the treatment is given during isometric contraction. Frequency and pressure of emitted vibrations are fixed during session. Basically it does not use synchronous and/or asynchronous frequency or pressure variation of acoustic pressure wave (during session).
The use of item (3) is subject to a complex system of identification of tendons subject to spasm and cannot treat deep muscles. It utilizes an intense pressure mechanical stimuli to be delivered to Golgi organ, whose values or emission frequency are not declared, as it is the case of the vibrations used to reduce pain during treatment. In addition to the fact that the treatment is to be delivered on points different from the ones of the PRAD, it basically does not use synchronous and/or asynchronous frequency or pressure variation of acoustic pressure wave (during session).
Item (4) is based on the use of micro waves or ultrasounds aiming at treating pains or breaking up calcium calculi (lithotripsy) generated in some organs or tissues. Other systems utilize mechanical shock waves (low emission frequency up to 21 Hz, pressure up to 5 bar). Anyhow, the above devices basically do not use synchronous and/or asynchronous frequency or pressure variation of acoustic pressure wave (during session).
Item (5) utilizes at the same time the emission of a pool of micro vibrations such as a magnetic field strength, photon electromagnetic, a light beam and a muscle acoustic vibration, all miniaturised inside a small probe. Basically it does not use synchronous and/or asynchronous frequency or pressure variation of acoustic pressure wave (during session).
Brief Description of Drawings
A brief description of enclosed drawing is given in the following:
Fig.1 Wave frequency and pressure are uniform and are suddenly and simultaneously increased or decreased in continuous (a) or pulse (b) mode. After the sudden
variation the same pressure as the initial one is reset , whereas the frequency is different from the initial one (c).
Fig. 2. Immediate synchronic pressure and frequency decreasing variations with subsequent intervals (sudden pulse variation mode) Fig. 3 Asynchronic waves emission, where sudden frequency variation may precede or follow pressure variation by repeated cycles or by inverted mode.
Fig. 4 Emission of frequency and pressure modulated waves (increasing and/or decreasing) in comparison with the main one. Synchronic modulation (a), asynchronic modulation, (b1) both in continuous emission mode (b2). Fig. 5 Transducer with several probes.
Fig. 6 Sketch of the device and of the transfer and control system of acoustic waves emission.
Fig. 7 Flow diagram.
Fig. 8 Sketch of the inner part of the PRAD Fig. 9 Symbology to drawn up the myofunctional map Fig. 10 Different kinds of probes
Best Mode for Carrying out the Invention Instrumental Features of the PRAD Acoustic pressure waves are characterized by some essential parameters: the wave pressure is proportional to the energy and it is in relation with pressure variations. The frequency is also proportional to the energy, but is related to the number of width peaks per time unit.
The PRAD is a frequency and pressure modulated apparatus, consisting of a specific acoustic pulse generator; pulses are transmitted to the tissues in an atraumatic way by skin contact using a small resonance cup, reducing or even resolving pain in a few minutes.
The use of the device can be either manual or automatic. The device is composed of a acoustic pressure wave generator theoretically varying from 1 (min) up to 500 Hertz (max) and from 0.001 (min) up to 8 Bar (max).
Actually the acoustic pressure wave generator consists of two compressors allowing to change wave frequency and pressure suddenly and synchronously; this is attained by
means of a system of pneumatic electro-valves controlled by a programmable electronic system. A further pressure variation can be obtained by a mechanical regulator. Therefore, frequency and pressure of a specific wave train are modulated either automatically by means of an electronic control system (Fig. 8) or manually by means of specific movements of probe.
The device transfers the wave train to a stiff plastic probe through of a small flexible plastic tube. The probe has, at its end, an expansion chamber of a larger diameter than the tube, of different shape and dimension (Fig. 10), which when put in contact with the skin of the patient to be treated, transfers the wave train to the tissues underneath the wave train (Fig. 6).